id|nct_id|recruitment_details|pre_assignment_details
713154|NCT04608500|Participants were enrolled at 46 sites in the United States from 01 June 2017 - 31 July 2018.|All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All the study assessments were performed as per the schedule of assessment.
713155|NCT04578496||
713156|NCT04574999|There were 167 patients enrolled in the study; 114 patients were randomized to the Estriol group and 53 to the placebo group.|
713157|NCT04555525||
713158|NCT04553497|35 who met the study inclusion criteria were randomly separated into two groups: the interferential current group (n = 18) and the sham group (n =17).|"18 patients were excluded
~Rheumatic diseases, 6
~Multiple trauma, 5
~Cerebrovasculer diseases, 3
~Peripheral nerve injury, 2
~Shoulder subluxation, 2"
713159|NCT04548622||
713160|NCT04542694||The study will randomize 200 patients. Given the possible non-inclusion of patients at the screening stage, the maximum number of patients to sign the Informed Consent Form in the Patient Information Leaflet and to participate in screening can be no more than 210 people.
713161|NCT04542226||
713162|NCT04534491|Study was conducted in US-sites and pharmacies from 25May2010 (first patient first visit) to 22Jun2011 (last patient last visit).|Twelve hundred thirty (1230) women arrived at the pharmacies for the enrollment phase and 855 qualified participants purchased Oxytrol and entered the actual use phase.
713163|NCT04534465|Study was conducted in US from 13Feb2013 (first patient first visit) to 19Mar2013 (last patient last visit).|Sixty-two (62) subjects was screened and fifty (50) subjected completed the study.
713164|NCT04532164|Study was conducted at single center in the US, between 10 JUN 2013 (first subject first visit) and 11 NOV 2013 (last subject last visit).|A total of 137 subjects were enrolled in the study and 132 received study treatment.
713165|NCT04531813|Study was conducted at single center in the US, between 10 JUN 2013 (first subject first visit) and 1 JUL 2013 (last subject last visit).|A total of 32 participants were enrolled in the study and 31 received study treatment.
713166|NCT04531540|Study was conducted at single center in the US, between 9 SEP 2013 (first subject first visit) and 18 OCT 2013 (last subject last visit).|A total of 225 subjects were enrolled in the study and 222 received study treatment.
713167|NCT04531527|Study was conducted at single center in the US, between 24 JUN 2013 (first subject first visit) and 28 JUN 2013 (last subject last visit).|A total of 32 subjects were enrolled in the study and 29 received study treatment.
713168|NCT04523831|The trial was designed to evaluate the effects of potential treatments in hospitalized and outdoor patients with mild to moderate COVID-19 infection, from 1 June to 30 august, 2020 in the largest COVID-19 dedicated hospital, Dhaka Medical College Hospital in Bangladesh.|Of 556 patients who screened and were assessed for eligibility, 400 underwent randomization. Total 200 patients received active drug and 200 patient received placebo.
713169|NCT04512482|Subject recruitment occurred from 6/14/2018 to 7/3/2018 from the graduate orthodontic clinic in the Indiana University School of Dentistry. 46 patients were screened for eligibility during this time frame.|46 of 46 subjects were randomized. Of those, 45 subjects completed at least one of the two study interventions (one of the study arms).
713170|NCT04502979||
713171|NCT04495712||
713172|NCT04491994|Enrollment during 10th April to 31st May 2020 at department of Pulmonology, Pakistan Emirates Military Hospital (PEMH) Pakistan.|672 confirmed PCR positive cases were assessed for eligibility. 132 did not meet selection criteria and excluded.Later,15 withdrew consent and 5 became symptomatic. During follow up 13 patients were found to be deviated from advised therapy and 7 were lost to follow up yielding a final study population of 500.
713173|NCT04491240||
713174|NCT04483011|Total of 42 subject screened, 18 enrolled into study and randomized into two groups with 9 subjects each.|
713175|NCT04474405|Enrollment occurred between Aug and Dec 2013. Subjects in the MRI and Amyloid Extension cohort received flortaucipir brain PET scans in Study T807000 (NCT01733355)|Subjects enrolled in the MRI/amyloid extension cohort were to be combined with the Brain PET subgroups for analysis per protocol. MRI allows previously-obtained flortaucipir scan and cognitive data to be combined with the PET scan results from the Brain PET subgroups for analysis.
713176|NCT04470375|Middle school students (Grades 5-8), live in Louisville, KY area, no PNE training sessions in the past, no history of epilepsy or seizures or adverse events with viewing VR in the past.|No exclusion prior to assignment
713177|NCT04468347|Enrollment occurred between Oct 2014 and Feb 2018 from the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL)|
713178|NCT04462731||Only recruited irreversible pulpitis cases that received single-visit root canal treatment.
713179|NCT04454138||
713180|NCT04450823|Recruitment was June through October of 2019|
713181|NCT04448210||
713182|NCT04446247||
713183|NCT04435808||
713184|NCT04425863|Recruitment at Eurnekian Public Hospital|
713185|NCT04425850|Health personnel|"Once consent was signed, compliance with all the eligibility criteria verified, and inclusion of the subject decided, the investigator assigns corresponding treatment according to the randomization carried out.
~It includes volunteers for both cohorts, provided they have test negative for COVID 19 in swabs obtained immediately before inclusion."
713186|NCT04422561||
713187|NCT04410159|All patients were recruited 2 to 3 days after date of diagnosis (nasophryngeal swab postive for SARS-C0V-2. All patients were asymptomatic and admitted to the hospital for observation|No significant event occurred after enrollment
713188|NCT04406194||57 subject screened
713189|NCT04404907||
713190|NCT04403113||
713191|NCT04400682||46 subjects screened
713192|NCT04399161|"Children: Participants were chosen from a government residential school located in Mysuru.
~Elderly: Participants were chosen from an old age home in Mysuru."|"Streptococcus mutans count determined in 72 participants
~Children: 36 of 45 fulfilled eligibility criteria. 6 participants were excluded before allocation (reason: left school).
~Elderly: 36 of 70 fulfilled eligibility criteria. 6 participants were excluded before allocation (reason: died, didn't co-operate)."
713193|NCT04397094||
713278|NCT04158466|There were 252 participants randomized but 251 participants received treatment. Participants are summarized by actual treatment group received.|
714677|NCT03400579||
713194|NCT04393493|We screened all consecutive patients admitted for acute decompensated heart failure (ADHF) and acute kidney injury (AKI) who were evaluated by the Nephrology service at the Hospital Civil de Guadalajara Fray Antonio Alcalde, an University Hospital, from July 2017 to February 2020.|Of 168 patients assessed for eligibility, 80 met inclusion criteria and were randomized to treatment
713195|NCT04390022||
713196|NCT04383132||
713197|NCT04376060||
713198|NCT04374500|"Seventeen healthy non-smoking male volunteers not taking any regular medication were recruited in Umeå, Sweden. Ten participated in protocol 1 and ten in protocol 2 (3 in both).
~Eighty-three men and women with established coronary artery disease were recruited from the cardiology outpatient clinic at the Royal Infirmary, Edinburgh, Scotland."|
713199|NCT04366583||High-risk bleeding ulcers were enrolled and defined as those with stigmata of an actively bleeding visible vessel, a non-bleeding visible vessel or adherent clots. Exclusion criteria were the presence of another possible bleeding site; coexistence of active severe illness, and systemic bleeding tendency.
713200|NCT04363879||
713201|NCT04359771|one eye (Right) from each patient was assigned to one arm (yellow MPL) and the other eye (Left) of the same patient to the 2nd arm (diode MPL). Therefore, the total number of enrolled participants was 15 contributing to total of 30 eyes (units) i.e there were 15 participants contributing to 15 eyes in each arm of the study.|
713202|NCT04358991||
713203|NCT04355663|Recruitment was realized between May 2015 and May 2017 at Department of Neurology, Facuty Hospital Royal Vineyard. MS patients were divided into three groups by an independent study coordinator according to availability of each therapist (in Groups 1 and 2) and amount of FES devices to borrow (in Group 3), and underwent three kinds of PT.|120 people were initially assessed for eligibility. 24 people did not fit to inclusion criteria, 1 did decline to participate and 1 injured. 92 were allocated into three groups.
713204|NCT04352660||
713205|NCT04350788||
713206|NCT04350307||
713207|NCT04348851||
713208|NCT04348357||
713209|NCT04343261||
713210|NCT04343222|Participants were patients with retinal disease requiring anti-VEGF therapy under the care of retinal specialists at the University of Wisconsin Hospital and Clinics.|
713211|NCT04343092||
713212|NCT04339296|Study participants were recruited from a Family Care Clinic during the period of June to October 2019. The clinic mailed invitation letters to potentially eligible participants. Also, potentially eligible participants with scheduled appointments at the clinic were flagged by clinic staff so they could be informed and directed to research staff.|A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups; 24 allocated to intervention and 26 allocated to control. A total of 16 spencer participants and 17 control participants completed the study. The study dropout rate was 33% (n=8) and 35% (n=9) in the intervention and control group, respectively.
713213|NCT04336475|Participants were recruited based on randomization in outpatient rheumatology clinic. First patient was enrolled on March 2017 and the last participant was enrolled in October 2018.|156 patients were evaluated and 74 met inclusion criteria. 14 patients refused to participate. 60 patients were randomized.
713214|NCT04329923||
713215|NCT04326842||
713216|NCT04325542||
713217|NCT04323592||
713218|NCT04322968||
713219|NCT04322526||
713220|NCT04322500||
713221|NCT04318535|This was an open label, randomized,3-treatment,3-period, single dose, crossover study. Bioequivalence between test Griseofulvin tablets (500 milligram [mg]) versus reference Griseofulvin tablets 500 mg and dose proportionality between test Griseofulvin tablets (250 mg and 500 mg) were evaluated in healthy adult participants under fed conditions.|A total of 36 participants were enrolled and received study treatment. The study had 3 periods: Period 1 (Day -1 to Day 5), Period 2 (Day 7 to Day 12) and Period 3 (Day 17 to Day 22) with a washout of atleast 7 days (not more than 14 days) between two subsequent dosing days.
713222|NCT04316260||
713223|NCT04308239||
713224|NCT04296448||
713225|NCT04296227|The final study population consisted of 85 qualified healthy subjects ranging from 18 to 81 years of age of any racial / ethnic background.|The subjects understood the study and provided consent for participation by signing the Independent Review Board (IRB) approved Informed Consent Form prior to start of the test. The subjects were informed about the clinical investigation within his/her ability to understand following the established informed consent process.
713226|NCT04295356||
713227|NCT04292899|Participants were enrolled at study sites in the United States, Europe, and Asia. The first participant was screened on 06 March 2020. The last study visit occurred on 30 June 2020.|4958 participants were screened. 4891 participants were enrolled. 4 participants in Part A and 49 participants in Part B did not receive treatment and are not included in the analyses.
713228|NCT04292639|The final study population consisted of 20 qualified healthy subjects, 10 males and 10 females, ranging in age from 18 to 52 yrs of any racial / ethnic background. Each subject understood the study and provided consent for participation by signing the Independent Review Board (IRB) approved Informed Consent Form prior to start of the test.|The subjects were healthy showing no evidence of significant medical problems as indicated by satisfactorily completing the health assessment form. Eligible subjects needed to meet all of the inclusion criteria and none of the exclusion criteria for participation.
713229|NCT04292171||
713230|NCT04289714||The initial recruitment total was 30, however, due to low number of participants completing the study, ethics approval was sought to extend the study. As a result 35 participants were recruited at the end of the study period.
713231|NCT04287517|Forty volunteer patients who had active pain in the neck region for the last 1 month, who applied to our clinic (Istanbul University Faculty of Medicine Sports Medicine Department), between 12 December 2019 - 01 March 2020, and who had an active myofascial trigger point were evaluated and included in the study.|Although 2 patients met the diagnostic criteria, they were not included in the study due to cervical hernia and cervical stenosis.
713372|NCT04014062||A total of 144 subjects were planned and enrolled. Of these 144, 2 subjects withdrew before dosing. Hence, 142 subjects started the study, were dosed, and were considered for the study analyses.
714678|NCT03400475||
714679|NCT03400449||
713232|NCT04285411|"Following Institutional Review Board (IRB) approval Title: Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry, Clinimark Study ID# PR 2019-353, eleven healthy adult volunteer subjects were screened and enrolled into the study. One subject was withdrawn due to poor device placement and time sync with the control oximeter."|
713233|NCT04281901|25 participants with chronic postoperative temporal bone cavity inflammation were recruited at the tertiary otorhinolaryngology referral centre between February- March 2020. In this period the list of patients was created based on examinations and documentation review. 2 participants had bilateral involvement, therefore 27 cases were recruited.|After random allocation 1 patient allocated to the group treated with standard conservative measures refused to participate in the study.
713234|NCT04280705|Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 21FEB2020 and 20APR2020.|
713235|NCT04280653|Normal healthy volunteers were interviewed to determine if they were interested in participating in the study. Recruitment was in the ophthalmologist office by the study staff.|There was no wash out or run-in period in this study. There was only 1 arm in this study.
713236|NCT04274556||
713237|NCT04272775|Participants took part in the study at 5 investigative sites in Japan from 05 June 2012 to 15 February 2019.|Relapsed and/or refractory multiple myeloma (RRMM) participants were enrolled to receive ixazomib 4.0 milligram (mg) in: Cohort 1 and along with lenalidomide 25 milligram per day (mg/day) and dexamethasone 40 mg/day (Rd) in Cohort 2. Study was terminated after completion of Cohorts 1 and 2 due to business decision; no safety or efficacy concerns.
713238|NCT04271020||
713239|NCT04270292||
713240|NCT04269629||
713241|NCT04267770||
713242|NCT04267380||The study was retrospective study of participants with rheumatoid arthritis (RA) who were tofacitinib initiators (first ever use of tofacitinib as reported by rheumatologist) on or after February 2016. Such participants were identified and their data was retrieved from United States (US) Corrona RA Registry database and assessed in this study.
713243|NCT04266925||49 youth soccer teams were included this randomized crossover design. All completed both arms.
713244|NCT04252092||
713245|NCT04251884||
713246|NCT04250987||
713247|NCT04243369||
713248|NCT04241146||
713249|NCT04238429||
713250|NCT04232137||
713251|NCT04224753||
713252|NCT04223232||
713253|NCT04222699||30 participants were S. aureus negative in the nose at enrollment and were withdrawn from the study as the use of mupirocin was not clinically indicated.
713254|NCT04218799||11 participants were S. aureus negative in the nose at enrollment and were withdrawn from the study as the use of mupirocin was not clinically indicated. 1 participant was discharged from the nursing home prior to receiving mupirocin.
713255|NCT04214951||
713256|NCT04214600||
713257|NCT04214080||
713258|NCT04209335|Participants were recruited from the general population with different lifestyles and jobs.|
713259|NCT04206800||
713260|NCT04205669||
713261|NCT04204200||All of 66 participants met the inclusion criteria and were randomised to treatment.
713262|NCT04195893||
713263|NCT04195880|All Veterans admitted to any of the eight experimental and eight control facilities (VA Community Living Centers) during the study timeframe, January 2016 - December 2017.|
713264|NCT04194151|Every patient who agreed to participate and required general anesthesia with endotracheal intubation by the same anesthesiologist|"Randomization was prior to data collection. The patient number was assigned by computerized randomizer to the 6 study groups. The collection was systematic from day one of the study, including all patients who met inclusion criteria and accepted participation.
~Of 192 patients enrolled, 186 met inclusion criteria."
713265|NCT04186806||
713266|NCT04186780|The patients were received in September, October and November in the nursing room at the University for the meetings.|"Individuals aged from 20 to 65 years old, who had at least one of the following biochemical markers at the borderline level, were recruited. Must be tolerant to bars ingredients and to Shiitake and they must be availability to attend the date and time of blood collection.
~Some of the individuals had diseases such as cancer, heart disease, neurodegenerative disease, diabetes, among others. These diseases could be confounders of the study and some recruited people had to be excluded."
713267|NCT04184297|The study investigate the effectiveness and safety of maintenance treatment with combination of tiotropium and olodaterol comparing to maintenance treatment with combination of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) based on existing data.|The study was conducted using existing administrative healthcare claims and laboratory result data captured in the HealthCore Integrated Research Database (HIRD). The observation period was from January 2013 until the most recent date available at the time that the cohort is extracted (March 2019).
713268|NCT04184271||
713269|NCT04183231||
713270|NCT04182217||
713271|NCT04179838||
713272|NCT04178590|October 2019 Department of Periodontology and Oral Medicine School of Dental Medicine University of Belgrade|Periodontitis patients with systemic and/or other oral disease or ongoing drug therapy are excluded.
713273|NCT04173741||
713274|NCT04171102||
713275|NCT04170686||146 potential participants were consented and screened. 25 individuals met exclusion criteria (severe depression) and were not randomized.
713276|NCT04169113||
713277|NCT04161079|Each MAR patient attended a single visit at the investigational site Mehiläinen hospital, Helsinki, during the period from 08 Nov 2019 to 29 Jan 2020. Maximum of 11 MAR patients who underwent successful MAR implantation and completed 2010-040 clinical investigation were anticipated to be qualifying for this follow-up clinical investigation.|"This follow up investigation compared 5-year timepoint data with the 2-year results of 2010-040 investigation, therefore enrollment numbers differ in the Protocol Section (7) and in the Participant Flow (12).
~7 MAR patients returned for 2010-040FU5 follow-up visit and 3 of these were with MAR Classic, 1 with MAR Regular and 3 with MAR Expanded."
714722|NCT03384953||
714723|NCT03384329||Eight enrolled patients dropped out during the 5-day run-in inpatient-study period
713279|NCT04150861|The trial was conducted at one site in China between June 2019 to December 2019.|A total of 133 subjects were screened, wherein, 24 subjects met the eligibility criteria and were randomized to the investigational medicinal product (IMP): 8 subjects each were exposed to Follitropin Delta (FE 999049) 12 μg, 18 μg and 24 μg, respectively. All the randomized subjects completed the trial.
713280|NCT04150224|Period 1: Single or double dosing (Cohorts 1-4) Period 2: Multiple dosing (Cohort 5)|
713281|NCT04149925||
713282|NCT04149405|"Postmenopausal women who were admitted to Ondokuz Mayıs University (OMU), Faculty of Medicine, Department of Endocrinology and Metabolism between 2016 and 2018.
~Patients eligible for the study were directed to OMU, Faculty of Dentistry, Department of Periodontology for periodontal examination after obtaining medical records."|Smokers and subjects who had received antibiotic treatment in the last 3 months and/or periodontal treatment in the last 6 months were excluded from the study.
713283|NCT04149353||
713284|NCT04144088||
713285|NCT04143373||In this study, the Enrollment number not equal to the number of participants who Started because this was a split-person design study in which 20 participants enrolled and within each individual, the left or right sides were allocated randomly for receiving these two types of saline.
713286|NCT04142216|Recruitment period: The assignment of patients to groups has began on October 14, 2019. It lasted on November 1, 2019.|in chewing group: one person reject to join to the study. one person chewing clove.
713287|NCT04140890|Participants were recruited from September 2019 to March 2020 in metropolitan Detroit, Michigan.|Drop out due to unable to comply to study procedure (n=4) Disenroll due to COVID-19 outbreak (n=5)
713288|NCT04138810||
713289|NCT04138758|In this cohort study, administrative data from the HealthCore Integrated Research Database (US, HIRD, Jan 2013 - March 2019) were used to identify and compare new users of Tio+Olo (Tiotropium and Olodaterol) with new users of LABA/ICS (Long-acting Beta2-Agonists/Inhaled Corticosteroids) combination therapy with respect to safety and effectiveness.|Only subjects that met all inclusion and none of the exclusion criteria were included. two cohorts (Initiators of Tiotropium + Olodaterol and patients receiving Long-acting beta agonist / inhaled corticosteroid) were established. The cohorts after propensity score matching were used for the analyses
713290|NCT04137627||
713291|NCT04136145|This was an open-label, randomized, parallel group, single dose study to evaluate safety and pharmacokinetics (PK) of belimumab, administered either intravenously (IV) or subcutaneously (SC) via an auto-injector in healthy Chinese participants.|A total of 171 participants were screened and 36 participants were enrolled and randomized in the study.
713292|NCT04130425||
713293|NCT04128293|This was a randomized, open-label, single dose, 4 period crossover study in healthy participants conducted at a single center in the United States.|A total of 16 participants were enrolled in this study. The study was early terminated by sponsor due to a potential contamination issue in the study drug after completion of treatment Period 2. Hence, treatment Periods 3 and 4 were not conducted.
713294|NCT04123665|Participants were recruited from one center in United States.|A total of 125 participants were screened for the study. Of these, 98 participants were enrolled and allocated to a randomized treatment. 27 participants were not enrolled, of which, 19 did not meet study criteria, 3 lost to follow-up and 5 withdrew their consent.
713295|NCT04122534||
713296|NCT04121078|Participants took part in the study at 1 investigative site in the United States from 15 October 2019 to 16 November 2019.|Healthy participants were enrolled in 1 of the 2 treatment sequences of this 2-period crossover study to receive TAK-906 25 milligram (mg) alone (Treatment A) and TAK-906 25 mg along with rifampin 600 mg (Treatment B).
713297|NCT04113785||
713298|NCT04112160||
713299|NCT04112069|20 pediatric participants|two-period, random-order, cross-over design. The two experimental periods each spanned5 days, including 4 nights (e.g. Monday-Friday). A washout period of ~ 3 days in duration separatedthe two experimental periods of the Pediatric Transitional Study Session.
713300|NCT04109703||
713301|NCT04109222|Participants were enrolled from 30 September 2019 to 7 October 2019 at 2 active sites in the United States.|A total of 90 participants were enrolled and vaccinated in the study.
713302|NCT04106817|Study participants were enrolled at a single site in California|Enrolled participants with evidence of an infection, elevated blood pressure, or abnormal lab values prior to Day 1 did not receive the investigational virus product.
713303|NCT04098809||
713304|NCT04095286|This was a single center, open-label, randomized, single dose, 3-period crossover study in healthy participants that compared the pharmacokinetics (PK) of a new lower dose formulation (dispersed in water and administered intact orally) of ambrisentan (AMB) tablet with the reference marketed AMB tablet (administered orally).|A total of 29 participants were enrolled at a single center in the United Kingdom.
713305|NCT04091659||
713306|NCT04090164|"The Hospital medical record system was searched to identify patients with the malignant neoplasm of the breast diagnosis. The information of an un-selected sample of 650 patients was retrieved from the system. Two-hundred forty-five patients with incomplete data were excluded. The remaining 405 patients were subjected for further analysis."|"The study group was retrospectively extracted from hospital file. However, The Dakahlia Governorate adult female Population is a historical control group derived from the raw data of a previous study. As such, this control group has not been recruited in the current study."
713307|NCT04086641||
713308|NCT04086576||
713309|NCT04086433||
713310|NCT04086407|Participants were pre-screened in clinic and using previous sleep study results within a two year time period with a diagnosis of Obstructive Sleep Apnea|No enrolled participants were excluded
713311|NCT04083404||
713312|NCT04082819|Healthy participants who were 25 years old and worked in Markham were recruited. Only healthy subjects were included; those who were under 25, had heart arrhythmias, atrial fibrillations or atrial flutters, an inaudible Korotkoff sound, wounds of the upper arms/wrists, missing fingers, and/or an arm circumference of more than 55 cm were excluded.|
713313|NCT04081961||
713314|NCT04080297||
713373|NCT04013789|The study was conducted at a single investigative site in the United States.|Of the 79 enrolled subjects, 11 were screen failures and 1 withdrew prior to randomization. This reporting group includes all randomized subjects (67).
713315|NCT04079790|This was a two-part, double-blind, randomized, sequential study to evaluate pharmacokinetics of Gepotidacin in healthy adult and adolescent participants. The study was conducted at a single center in the United States.|A total of 34 participants were randomized in this study (Randomized Population): 16 adult participants in Part 1 and 18 adolescent participants in Part 2.
713316|NCT04079127||
713317|NCT04079114||
713318|NCT04076787|International metastatic renal cell carcinoma database consortium (IMDC) real-world database was used to collect the data from the medical charts of adult participants with clear metastatic renal cell carcinoma (mRCC), who received first-line sunitinib therapy in a real-world setting, from January 2010 to February 2018.|
713319|NCT04072432||
713320|NCT04071392||
713321|NCT04069715||
713322|NCT04069221||"Screened volunteers: 48
~Screening failures:
~ECG: 7 Clinical laboratory: 3 Medical history: 2 Vital signs: 1 Physical examination: 1 Other: 1
~Approved but not dosed Reserve: 5 Not in clinic/Personal: 2"
713323|NCT04067401|Recruitment of classes was staggered over 16 months-Oct 2017 - Jan 2019-with classes matched. Clusters of class units within training squadron were formed over time as they became available, selected to maximize balance (e.g., AFSC), and randomized to one of two training conditions.|
713324|NCT04067141||
713325|NCT04066647||
713326|NCT04065074||
713327|NCT04061694||
713328|NCT04057235||
713329|NCT04055675||
713330|NCT04054011||No significant events pertaining to pre-assignment.
713331|NCT04053465||Participants were excluded if they did not reach the aerobic fitness criteria or if there were foreseen scheduling conflicts.
713332|NCT04053270||
713333|NCT04053023|This was an open-label, drug interaction study to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and OCA conjugates in healthy participants. The study was conducted at a single center in the United Kingdom.|A total of 19 participants were enrolled in Part A. Part B was optional and since there was no clinical benefit seen in conducting Part B of this study, no participants were enrolled in Part B. The study was concluded following completion of Part A.
713334|NCT04051710||
713335|NCT04051684||
713336|NCT04050722|Participants were recruited from one center in United States.|A total of 154 participants were screened, of whom 130 were randomized for treatment, 17 were screen failures, 3 withdrew consent prior to randomization, and 4 were not randomized as sufficient participants were already enrolled in the study.
713337|NCT04050618||
713338|NCT04050605||
713339|NCT04049578||
713340|NCT04049552|Each subject enrolled was used as both active intervention and placebo, using 2 keloids on the same subject, color coded to have either rapamycin ointment or placebo ointment applied.|
713341|NCT04048681||This is a cross-over trial, and participants were assigned to receive diet soda, regular soda, and carbonated water in a random order.
713342|NCT04047121|5-years data were retrieved from insurance claims Truven Health MarketScan Research Databases and were evaluated in 5 months of this retrospective, observational study. Participants who initiated treatment with tofacitinib, adalimumab or etanercept for rheumatoid arthritis (RA), between January 2014 and September 2016 were involved in this study.|5-years (January 2012 to September 2017) included pre-index of 2 years, 2 years to capture treatment initiation (index date), and 1 year for follow-up post-index. Index date was first prescription date of treatment (tofacitinib, adalimumab or etanercept) from January 2014 to September 2016.
713343|NCT04045964||
713344|NCT04043416||
713345|NCT04042324||All twelve participants enrolled in the study were randomly assigned to cross-over between the three treatments on Days 1, 3 and 5.
713346|NCT04041453||
713347|NCT04041219||
713348|NCT04041037||
713349|NCT04039867||
713350|NCT04039412|We conducted an interventional randomized trial at the internal medicine department clinic, Zagazig University Hospital, Zagazig, Egypt, in the period from July 2018 to June 2019. We allocated the participants attending the clinic by simple randomization over the three treatment groups.|
713351|NCT04037748||
713352|NCT04036838||
713353|NCT04035577||One participant withdrew from the study after signing the consent form but before initiating any of the study activities, and we consented an additional participant in their place. A total of 21 participants consented.
713354|NCT04035564|"Recruitment period: March 30, 2018 - February 28, 2020
~Inclusion Criteria:
~Preterm infants <35 Weeks gestation, less than 24 hrs of age.
~Exclusion Criteria:
~Urinary malformations
~Congenital abdominal wall defect
~Intestinal atresia / obstruction
~Congenital heart defect
~Location: Neonatology (Pediatric Hospital)"|
713355|NCT04034043||
713356|NCT04032652||The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
713357|NCT04032613||
713358|NCT04027803||
713359|NCT04027218||63 individuals signed informed consent form, but one of them did not meet all the inclusion criteria. Then 62 participants were included in the study.
713360|NCT04024501|All subjects signed and dated the informed consent form (ICF) before any study procedures were performed.|The study included a Screening Period of maximum 28 days.
713361|NCT04023695||
713362|NCT04023578||
713363|NCT04022668||
713364|NCT04020822||
713365|NCT04019990||During evaluations and training, 1 wheelchair basketball player, and 3 stand-up basketball players were excluded from the study as they failed to meet the inclusion criteria.
713366|NCT04018664|Only Part A of this study was completed. Treatment arms summarized are those that were used on in Part A.|
713367|NCT04018001||The study was a retrospective follow-up study of participants treated with index medication (tofacitinib) and enrolled in a health insurance plan for a minimum of 24 months.
713368|NCT04017611||
713369|NCT04016623||
713370|NCT04016259||
713371|NCT04015232||
713374|NCT04012970||
713375|NCT04011592||
713376|NCT04010370||
713377|NCT04007159|Participants were recruited from one center in Brazil.|A total of 369 participants were screened, of which 302 participants were enrolled and 280 participants were randomized in induction phase and 258 participants went into the challenge phase.
713378|NCT04007107|The trial was conducted at one site in the Netherlands.|Participants were randomised in a 2×2 scheme evenly to 4 sequences (A, B, C and D) of either DV3396 or PDS290 and side of injection (right/left) on abdomen.
713379|NCT04006795|Participants were recruited from one center in Brazil.|A total of 61 participants were screened, of which 40 participants were enrolled and 37 participants were randomized, 3 enrolled participants were not randomized as they missed scheduled site visits. All 37 randomized participants completed the study.
713380|NCT04006366||
713381|NCT04005885||All subjects were fitted with comfilcon A for one month and then the subjects were randomized to wear two daily disposable lenses for one week.
713382|NCT04005391||
713383|NCT04002973||
713384|NCT04002960||
713385|NCT04002791||
713386|NCT04002648||
713387|NCT04000815||For the last 6 months, patients with drug use that may affect menstruation like oral contraceptives, patients with cardiac or renal disease and therefore drug use, causes of infertility other than unexplained infertility, history of ovarian surgery, presence of polycystic ovary syndrome, and patients with irregular menstruation.
713388|NCT04000373|Patients were recruited and enrolled between July 2019 and October 2019 in the outpatient clinic.|
713389|NCT03997825||
713390|NCT03995680||
713391|NCT03993392|A total of 49 participants were screened and a total of 26 (53.1%) were enrolled into the study (i.e., were administered TM buprenorphine in the induction phase).|"Reasons not enrolled:
~10 patients did not meet inclusion/exclusion criteria;
~3 did not meet Day 1 check-in criteria;
~3 withdrew consent;
~3 were not entered because the study was closed to enrolment;
~4 patients were for other reasons"
713392|NCT03993210||
713393|NCT03992482|Subjects were recruited from the clinical practice of the investigator at the time of their routine eye examination visit. The clinical practice is located in the Illinois Eye and Ear Infirmary (EEI), the University of Illinois at Chicago (UIC). The first participant was enrolled on 6 May 2019, and the last participant was enrolled on 7 June 2019.|
713394|NCT03992014|This was a two-period, mass balance study in healthy male participants to assess the pharmacokinetics (PK), excretion and metabolism of Linerixibat. The study was conducted at a single center in the United Kingdom.|A total of 10 participants were screened of which 4 failed screening and 6 participants were enrolled in the study. The study had 2 treatment periods (each of 8 days) with a washout of 7 days. All participants were followed-up at Day 34.
713395|NCT03991715||
713396|NCT03989570||7 patient refuse to participate
713397|NCT03989427|221 students were screened for eligibility between January 25, 2019 to May 10, 2019 in the Out-Patient Department (OPD) of Dept.of Periodontics, Poly clinic A, Klinik Pergigian, Melaka, Malaysia.|30 of 221 participants were randomized. Of those not randomized, 120 did not meet inclusion criteria and 71 declined to participate.
713398|NCT03988907||
713399|NCT03988426||
713400|NCT03988088||The 3-month open-label extension addendum was to evaluate safety and tolerability.
713401|NCT03985657|193 persons with Marfan syndrome were screened. Persons were recruited from the Johns Hopkins Marfan Clinic and the external Marfan Community via the Marfan foundation. Inclusion was based on a clinical diagnosis of Marfan syndrome (Ghent Criteria) or genetic testing. Persons were excluded if they had any chronic lung disease, other sleep disorders aside from sleep apnea, were on blood thinners, or had uncontrolled blood pressure. Recruitment occurred between 09/2018 and 11/2019.|
713402|NCT03984838|The was a single dose, open-label study in healthy Japanese participants for the evaluation of pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablet of Dolutegravir (DTG)/Rilpivirine (RPV) 50 milligrams (mg)/ 25 mg|A total of 16 participants were enrolled in the study
713403|NCT03984825|This was a Phase 1, open-label, fixed-sequence, 1-way drug-drug interaction (DDI) study to assess the Pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability of GSK3640254 and an oral contraceptive containing Ethinyl estradiol/Levonorgestrel (EE/LNG, Portia) when administered alone and in combination in healthy female participants.|A total of 23 participants were enrolled in the study
713404|NCT03983317||Participants completed the Baseline Phase first, so participants who did not complete the Baseline Phase did not start the Treatment Phase.
713405|NCT03982433|Recruited from medical clinic and ongoing cohort|
713406|NCT03979807|The study compared the treatment persistence of patients with Chronic Obstructive Pulmonary Disease (COPD) using Olodaterol/Tiotropium Bromide inhaled via Respimat soft mist inhaler (SMI) versus patients with COPD using Umeclidinium/Vilanterol inhaled via the Ellipta Dry powder inhaler (DPI).|Only subjects that met all inclusion and none of the exclusion criteria were included in the study. Initiators of Olodaterol/Tiotropium Bromide were matched to patients receiving Umeclidinium/Vilanterol using a 1:2 propensity score matching, resulting in a matched cohort of 11296 overall.
713407|NCT03979079||
713408|NCT03979066||One participant was enrolled but was not randomized, as the participant was determined to be a screen failure.
713409|NCT03977935||
713410|NCT03977818||
713411|NCT03977727|45 patients were screened for eligibility between June 11,2019 and November 21, 2019 at a diabetes clinic in Austin, TX|40 of 45 participants were randomized. All 5 who were not randomized did not meet inclusion criteria.
713412|NCT03976466||Inclusion critera for patients to complete enrolled protocol were: patients over 60 years old, no history of cephalosporine allergy, to have any of the non-modifiable risk factors, patients who accept blood transfusion. Patientes who are institutional entitled.
713413|NCT03975790||The study was a retrospective population-based register study. Detailed data on each participant was retrieved from the Truven Health MarketScan Research Database and assessed in this study.
713414|NCT03974802||
713533|NCT03854253||
713582|NCT03822078|This study was conducted at one clinical center in Japan.|The study consisted of 5 dose cohorts of 8 participants. Within each dose cohort 6 participants were randomly assigned to receive denosumab and 2 participants to receive placebo.
714724|NCT03384316||
714725|NCT03384173||
713415|NCT03973905|The present analysis has been performed on the data set of a case-control study conducted in 6 US Emerging Infection Program Network states, either statewide (4 states) or in select counties (2 states) by Skoff et al., 2017.|The primary study was a case-control study evaluating the effectiveness of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines (Boostrix and Adacel) administered during pregnancy in preventing pertussis in infants.
713416|NCT03972813|Recruitment period: summer 2019 Recruitment locations: immunization clinics and schools in 40 townships in Shanghai, China|
713417|NCT03972137|Participants were recruited from the New Brunswick, New Jersey area via flyer postings, clinic referrals, and social media advertisements. The first participant was enrolled April 24, 2019 and the last participant was enrolled November 12, 2019.|The intervention occurred across 10 sessions. All participants received individualized heart rate variability biofeedback at each session, smoking cessation therapy during 6 of the sessions and 8 weeks of transdermal nicotine patches. Two of the twelve consented participants who attended the baseline visit were not eligible and were not enrolled.
713418|NCT03970824||
713419|NCT03970395|Of the 129 infants screened at Sant'Anna Hospital, 96 were enrolled between September 2016 and June 2019.|
713420|NCT03966365||
713421|NCT03965754||
713422|NCT03965533|This was a double-blind, placebo-controlled, randomized, parallel group, two-part study to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) dose of GSK2831781 in healthy Japanese and Caucasian participants (Part A) and subcutaneous (SC) dose of GSK2831781 in healthy Caucasian participants (Part B).|A total of 30 participants were screened and 16 participants were enrolled in Part A (14 were screen failures). A total of 41 participants were screened and 20 participants were enrolled in Part B (21 were screen failures). Placebo arms across similar dosing strategies were combined in Part B.
713423|NCT03965403||
713424|NCT03965052||
713425|NCT03965039||
713426|NCT03964220|A retrospective cohort data analysis evaluated the effectiveness of add on therapy with Tiotropium Respimat® 1.25 microgram comparing to increasing the dose of Inhaled Corticosteroid (ICS) in patients with a diagnosis of Asthma and on ICS/Long-acting beta-agonist (LABA) therapy.|This study included asthma patients from two retrospective data sources (IMS Pharmetrics and EMRClaims+) after propensity score matching based on ICS/LABA dose on initiation date, demographics, Charlson Comorbidity index (CCI) score, specific comorbidities, medications and asthma control status.
713427|NCT03962790||A total of 95 participants were enrolled in this study however one participant was never randomized due to screen failure therefore, 94 participants were randomized to receive study drug.
713428|NCT03962634||
713429|NCT03961308|Participants took part in the study at 1 investigative site in the United States from 12 March 2018 to 21 November 2018.|Healthy participants were enrolled in one of the two device presentation groups to receive vedolizumab subcutaneous (SC) 108 milligram (mg) using a prefilled syringe (PFS) or using an investigational device. Primary objective was to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
713430|NCT03961295|Participants took part in the study at 1 investigative site in the United states from 22 February 2018 to 28 August 2018.|Healthy participants were enrolled in one of the two device presentation groups to receive vedolizumab subcutaneous (SC) 108 milligram (mg) using prefilled syringe (PFS) or using an investigational device. Primary objective was to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
713431|NCT03961100||
713432|NCT03959332||
713433|NCT03958071|This retrospective database study was conducted to understand differences in characteristics of Idiopathic pulmonary fibrosis (IPF) patients who were newly prescribed pirfenidone or nintedanib, and those who did not receive a prescription for an antifibrotic treatment.|The study includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data.
713434|NCT03954626|The study enrolled patients from 3 centers from the United States.14 patients were enrolled and analyzed in the study.|
713435|NCT03954158||
713436|NCT03953820|A total of 43 healthy (except for seizure disorder) volunteers were screened for eligibility in this study.|31 of the 43 screening participants were enrolled and randomized at 5 study sites in the United States. Of those not randomized, 7 did not meet protocol eligibility criteria and 5 were judged eligible but decided not to participate or were not selected to participate in the study since there was already a sufficient number of subjects.
713437|NCT03953183||
713438|NCT03951610||
713439|NCT03950674|The MK-3475-189-Japanese Extension Study enrolled a total of 30 participants and the analyses included 10 participants (pembrolizumab =4; control = 6) that had been previously enrolled in the MK-3475-189 global study (NCT02578680), resulting in a total of 40 participants.|These results are based on a database cutoff date of 20-May-2019, at which time 30 participants were ongoing in the study. Four participants randomized to receive Control treatment had switched over to receive pembrolizumab monotherapy treatment. These results are for randomized treatment only.
713440|NCT03949621|Participants took part in the study at 1 investigative site in the United States from 06 February 2018 to 13 August 2018.|Healthy participants were enrolled in one of the two device presentation groups to receive vedolizumab subcutaneous (SC) 108 milligram (mg) using prefilled syringe (PFS) or using an investigational device. Primary objective was to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
713441|NCT03948581|Participants took part in the study at 1 investigative site in the United States from 21 February 2018 to 21 September 2018.|Healthy participants were enrolled in one of the two device presentation groups to receive vedolizumab subcutaneous (SC) 108 milligram (mg) using prefilled syringe (PFS) or using an investigational device. Primary objective was to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
713442|NCT03946124||
713443|NCT03943095|Participants were recruited from one center in Canada|A total of 123 participates were screened and enrolled, out of which 104 participants were randomized in the study and 19 participants were not randomized.
713808|NCT03698279|The study was conducted at 16 centers in United States (US) and Canada from 09 October 2018 to 16 October 2019.|A total of 665 participants were enrolled in the study.
713444|NCT03937479|The study was conducted at 49 study centers in the United States of America between 01 May 2019 and 15 November 2019. Overall, 416 adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) on a stable background therapy of open-label tiotropium were randomized and 413 patients received double-blind study treatment.|Following Screening on Visit 1, eligible patients entered a 14-day run-in period, where they received tiotropium once daily. At Visit 2, patients were re-assessed for eligibility according to randomization criteria. Patients were randomized equally across 5 double-blind treatment groups (4 doses of RPL554 or placebo).
713445|NCT03936608||
713446|NCT03936244||
713447|NCT03933774|This is a split-face trial. A single patient with paired lesions will be enrolled.|
713448|NCT03933618|Men will be incentivized to come to each clinic appointment with $20 dollars at the end. If they complete the study they will be able to earn $100. Men will be incentivized to not use phosphodiesterase inhibitors throughout the study by giving them three 100mg tablets of Viagra per month of the study for a total of twelve 100 mg tablets.|
713449|NCT03933462||
713450|NCT03933449|This results disclosure is based on a data cutoff date of 13-Feb-2019, at which time 26 participants were ongoing in the study.|
713451|NCT03930641|Thirty-five subjects were enrolled and 34 received one IVT injection of brolucizumab 6 mg PFS. One subject withdrew consent before receiving treatment.|
713452|NCT03928522||
713453|NCT03928327|Participants took part in the study in the United States from 02 May 2019 to 16 August 2019.|Healthy participants were enrolled in this 2-period study to receive: TAK-788 20 mg (Treatment A) along with itraconazole 200 mg (Treatment B) and TAK-788 160 mg (Treatment C) with rifampin 600 mg (Treatment D) in sequential manner to evaluate drug-drug interaction.
713454|NCT03927950|Department of Psychiatry|
713455|NCT03926065|Children aged 3 to 5 years old were recruited from classrooms at three childcare centers in State College, Pennsylvania by distributing letters to parents between May 2019 and October 2019.|
713456|NCT03923933|Patients were recruited from the nephrology clinic in the Hospital General de México, between May and August 2019. All those with stage 4-5 chronic kidney disease, who had chronic use of loop diuretics and hypertension, were invited to perform an impedance measurement. Those with volume overload were invited to participate in the protocol.|
713457|NCT03923530|Recruitment at Malcom Randall VA Medical Center|
713458|NCT03921723|This was a Phase 1, open-label, non-randomized, single dose study in healthy adult participants conducted at a single center in the United Kingdom (UK) to assess the prototype liquid fomulations of dolutegravir (DTG) versus DTG dispersible tablets (reference).|A total of 22 participants were enrolled in the study. The washout time between dosing in consecutive study periods was a minimum of 7 days.
713459|NCT03918239|This study was conducted at a single site in United States of America from 14 May 2019 (first participant first visit) to 13 November 2019 (last participant last visit).|A total of 190 participants were enrolled and received the treatment. Out of which, 173 participants completed this study.
713460|NCT03914950|Participants were recruited based on physician referral at one university hospital between February 2014 and January 2019. The first participant was enrolled on February 7, 2014, and the last participant was enrolled in January 2019.|Of 174 enrolled participants, 120 participants met ALL inclusion criteria having TOF-18F-FDG PET/CT with diagnostic CT of the abdomen or upper abdomen AND biopsy or FNA or operation of the pancreas and were analyzed. Participants not completing the study were excluded and therefore not analyzed (54 participants).
713461|NCT03914417|Recruitment/Enrollment from Jan 1, 2013 - Jan 1, 2015|
713462|NCT03913377|A total of 78 subjects were enrolled into this study. Of those enrolled, 65 subjects were assigned to either the observational arm (21) or the interventional arm (44), while 13 subjects failed to meet all eligibility criteria.|Of the 21 subjects assigned to the observational arm, all subjects completed the study. Of the 44 subjects assigned to the interventional arm 2 subjects were discontinued. A total of 63 subjects completed the study.
713463|NCT03911960|3 participants consented to the study and were randomized but completed none of the study procedures (did not complete the baseline questionnaire, any of the counseling sessions, or the follow-up visit).|
713464|NCT03911752||
713465|NCT03909763||
713466|NCT03909295|A total of 52 participants were enrolled across 17 centers in Japan.|"This study was terminated early based on the pre defined early termination criteria of the primary endpoint of PARAGON-HF (CLCZ696D2301) was not met in the protocol."
713467|NCT03909009|Participants were recruited from Physical Medicine and Rehabilitation (PMR) outpatient clinics of a university hospital.|Twenty-eight patients were evaluated for participation in the study. Eight patients were excluded.
713468|NCT03907579||
713469|NCT03907241||
713470|NCT03905642||
713471|NCT03904420||
713472|NCT03902613||
713473|NCT03902392||
713474|NCT03901313|A total of 24 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study.|
713475|NCT03901105|Scans were acquired from subjects previously enrolled in the AZES (NCT02245737) PET substudy (N=205), including mild AD (n=141) and mild cognitive impairment (MCI) due to AD (n=64).|To be included in the study, subjects had to have a valid baseline flortaucipir PET scan and clinical dementia rating (CDR) assessments at baseline and 18 months.
713476|NCT03901092|Subjects were not recruited for this study. Study scans were selected from 2 previously completed imaging studies. Scans previously acquired from Study A16 (NCT02516046) and A05 (NCT02016560) were read by 5 independent, blinded to other study information.|
713477|NCT03900299||
713478|NCT03899064|First Subject First Visit: 18-Feb-2019; Last Subject Last Visit: 05-Apr-2019|"This study was a randomized, double-blind, controlled, within-subject comparison study to evaluate the potential of MC2-01 cream to induce a photoallergic skin reaction.
~The study consist of a 3-week Induction phase, followed by a Challenge phase."
713479|NCT03898349|This was not an intent to treat design, therefore UI and AI groups were combined to compare texters and non-texters from each of the groups (and control).|
713480|NCT03897179||
713481|NCT03895632||
713482|NCT03895307||
713483|NCT03894449||
714726|NCT03383887||
718785|NCT02711800||
718786|NCT02711345||
713484|NCT03892564|First Subject First Visit: 27-Feb-2019. Last Subject Last Visit: 09-Mar-2019|"The study consist of a screening day + treatment period of 4 consecutive days.
~The study is a within-subject comparison study of MC2-01 cream and vehicle. The products were each applied to 2 sites; one was irradiated and other non-radiated. The irradiated and non-irradiated sites were compared to each other and with an untreated irradiated site."
713485|NCT03891641||
713486|NCT03889444||
713487|NCT03889028|Adult patients undergoing T-cell replete allo-HSCT at 20 different centers in Spain from September 2014 to December 2015 (Registry of the Working group on Infectious and Non-Infectious Complications of the GETH-Spanish Hematopoietic Transplantation and Cell Therapy Group-). A total of 218 adult patients who received an unmanipulated allo-HSCT at the Clinical University Hospital of Valencia from March 2010 to May 2019 (excluding patients recruited in the GETH registry) were also included|
713488|NCT03888755|The study was conducted at 8 sites in Japan between 18 March 2015 (first participant first visit) and 12 February 2016 (last participant last visit).|A total of 8 Japanese participants were enrolled and included in the study treatment.
713489|NCT03888482|This study was performed at 8 study centers in the United States (US).|Of the 154 enrolled, 2 were exited from the study as screen failures and 1 subject was randomized but not exposed. This reporting group includes all exposed subjects (151).
713490|NCT03888469|This study was performed at 5 study centers in the United States (US).|This reporting group includes all randomized subjects (92).
713491|NCT03888391||
713492|NCT03888274||
713493|NCT03887442|The study was carried out in 10 academic medical centers in Spain. First patient in was on 16-February-2011 and the study was closed (last patient in) on 02-October-2012.|
713494|NCT03887429||
713495|NCT03887286||
713496|NCT03886701||
713497|NCT03885726|Recruitment for this study took place in both an inpatient hospital setting and an outpatient medical clinic setting.|Of the N=32 enrolled patients, only N=28 completed both study arms. An additional N=3 patients were excluded from study analysis, making the total number of patient data analyzed post-hoc N=25.
713498|NCT03883386||
713499|NCT03882801|Participants were enrolled from 3 centers in a single country|24 participants were randomized and enrolled, 23 were administered with at least one dose of study drug, 1 participant was never dosed.
713500|NCT03882424||
713501|NCT03882047||
713502|NCT03881670||
713503|NCT03879772||
713504|NCT03878758||Each subject received more than one treatment
713505|NCT03878745||
713506|NCT03876743||
713507|NCT03875664||Excluded after enrollment if intraoperative decision made not to perform posterior colporrhaphy or perineorrhaphy.
713508|NCT03870997|Existing members of the online health platform Achievement who met the inclusion criteria were blinded to their study participation status and were not asked to take any action to enroll in the study. Participants were randomized to one of the digital interventions or to no intervention. All study activities were conducted virtually.|
713509|NCT03870893||
713510|NCT03870737||
713511|NCT03870555|Participants took part in the study at 1 investigative site in the United States from 08 March 2019 to 16 May 2019.|Healthy adult participants were enrolled in this 3-period cross-over study in 1 of the 3 treatment sequences to receive TAK-954 0.1 milligram (mg) or Placebo on Day 1 (Lead-in Dose), followed by TAK-954 (0.5 mg, 1 mg or 2 mg) or Placebo on Day 2 (Treatment Dose) of each study period.
713512|NCT03869450||
713513|NCT03868631|282 people responded to the screening survey online from August 2016 through January 2017. Data collection was completed by May 2017. 61 participants were randomized for study participation. Recruitment emails were sent to students at Arizona State University and others were contacted via word of mouth.|
713514|NCT03868254||
713515|NCT03866434|This study was conducted at single site in United States of America from 26 February 2019 to 10 April 2019.|A total of 20 participants were enrolled and completed the study.
713516|NCT03865446||
713517|NCT03865329||
713518|NCT03864653||
713519|NCT03863210|"The study took place in family medicine offices from 1 March to 1 September 2014. Two offices were in the city of Split, one office in the island of Brač and one in the island of Korčula.
~There were 781 women in age 45 to 60. All patients responding to the inclusion criteria listed below are called by telephone or directly contacted in FM offices."|There were 104 women enrolled in this study, but two women came out of the study at the beginning of the study.
713520|NCT03862040|This study was conducted at 3 sites in the United States. Seven adults with known or suspected bacterial pneumonia being treated with standard of care (SOC) antibiotics and requiring mechanical ventilation were enrolled.|
713521|NCT03861845||
713522|NCT03861559|A total of 201 participants were randomized into the study (101 mometasone furoate; 100 placebo).|
713523|NCT03860753||
713524|NCT03859960|Individuals with SCI recruited from the inpatient rehabilitation unit of an education and research hospital. Recruitment began in September 2014 and was completed in May 2018.|
713525|NCT03859622||
713526|NCT03858894||
713527|NCT03858335||
713528|NCT03857750|Patients were included from the Departments of Anaesthesia, Centre of Head and Orthopaedics and Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Denmark in the period of the 27th of March 2019 to 7th of November 2019.|Five of 37 patients were excluded due to rescheduling, rapid sequence induction, prone position and different anesthetic medication. 3 patients in each group have missing data on duration of action due to supplementary doses of rocuronium.
713529|NCT03857243||3 subjects were found not eligible for participation after signing consent.
713530|NCT03857230|Duration of participation was about 73 days: screening period (up to 7 days), preparation period (up to 28 days), the 1st period (9 days), the 2nd period (9 days), and the follow-up period (28 days starting from the first day of the 2nd period). The wash-out period is 10 days.|28 healthy female volunteers aged 18 to 40 years inclusively have been enrolled according to the inclusion and non-inclusion criteria, among them 4 back-ups enrolled in the study to replace the volunteers excluded before the study completion.
713531|NCT03855228||
713532|NCT03855189||
713534|NCT03851016|27 residents were screened for eligibility between April 08, 2019 and April 12, 2019 from two comparable nursing homes in the Houston Texas Metropolitan area.|24 of the 27 participants, 12 from each home met inclusion criteria. The two nursing homes were allocated by the PI to either Life Story Book Intervention first or Usual Care first. All participants in the same nursing home received the same intervention at the same time.
713535|NCT03850496||
713536|NCT03850444|The China extension study enrolled 262 participants. Of the 262 total participants enrolled, 92 were also previously enrolled in the global study for MK-3475-042 (NCT02220894).|These interim results are based on a database cutoff date of 04-September-2018, at which time 137 participants were ongoing in the study.
713537|NCT03850093|66 patients who underwent endoscopic sinus surgery were eligible for the study|
713538|NCT03849690|Participants took part in the study at 1 investigative site in the Unites states from 27 February 2019 to 15 April 2019.|Healthy participants were enrolled in this single sequence, 2-period cross-over design study to receive TAK-906 25 milligram (mg) in Study Period 1 followed by esomeprazole 40 mg and TAK-906 25 mg in Study Period 2.
713539|NCT03849300||
713540|NCT03848910||
713541|NCT03848871||
713542|NCT03848455||
713543|NCT03848416||Participants were randomized to 1 of 3 treatments, Reference, Test Formulation 1 or Test Formulation 2.
713544|NCT03848403||Participants were randomized to a treatment sequence in one of three periods. The study was stopped for some participants per sponsor decision and these participants did not move on to subsequent periods in the study at the protocol interim analysis.
713545|NCT03848221||
713546|NCT03848208|Participants were enrolled in a single center in Portugal.|Participants were randomly assigned to receive a single oral dose of cytisine or placebo in a 3:1 ratio (6 cytisine:2 placebo) for each dose cohort. Seventy-four (74) participants were randomized; 2 were withdrawn from the study by physician decision before dosing (1 due to high blood pressure and 1 due to noncompliance with protocol restrictions).
713547|NCT03847987|Healthy male and female participants between ages 18-55 years, who were nonsmokers for at least 6 months.|
713548|NCT03847610||One volunteer withdrew consent to undergo microdialysis on the study day and was withdrawn from the analysis. The participant did not cite a reason for declining microdialysis catheter insertion. Therefore, ten volunteers were included in the study.
713549|NCT03847233||
713550|NCT03845933||
713551|NCT03844945|Participants were recruited at 25 clinical trial sites in Japan.|Prior to enrollment, adult participants were to have a Screening Visit and 2 Qualification Visits to allow for washout of ocular hypotensive medication if needed.
713552|NCT03843372||
713553|NCT03842683||
713554|NCT03841331|The study was conducted at 41 sites in US from 22 January 2019 to 21 January 2020. All subjects who met the study entry criteria were randomized in a 1:1 ratio to receive daily oral doses of serlopitant 5 mg or placebo.|During the screening period (3 weeks), all subjects were evaluated for eligibility and assessed for conditions associated with chronic pruritus. Subjects were to complete an electronic diary (eDiary) at the Screening visit.
713555|NCT03840278||2 were ineligible due to lacking a designated contact or were taking arrhythmogenic medications
713556|NCT03840135||
713557|NCT03837028||
713558|NCT03836859||
713559|NCT03836729|This was an open-label, single-sequence one-way interaction drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics (PK) of tenofovir alafenamide (TAF) and emtricitabine (FTC).|A total of 16 participants were enrolled in the study.
713560|NCT03836664|A total of 26 participants in the age group of 18-65 years were recruited from the general neurology clinics at the University of Kansas Medical Center. One participant did not meet inclusion criteria and was excluded from the study. Finally 25 participants were enrolled. Recruitment period ended from 4/21/17 to 2/23/18.|Out of the 26 recruited participants, upon screening one participant no more met inclusion criteria due to worsening of his clinical condition. He had an increase in his migraine frequency and therefore, did not meet the inclusion criteria of 1-8 migraine episodes per month. He was considered to be a screen fail and was not enrolled in the study.
713561|NCT03835546||
713562|NCT03835221||
713563|NCT03835078|42 subjects were enrolled but three subjects did not satisfy the minimum number of days / hours of wear during the study and excluded from all the analysis.|
713564|NCT03832387||
713565|NCT03832322||
713566|NCT03831971||26 subjects signed consent. 14 subjects not eligible. 12 subjects underwent study.
713567|NCT03831451||
713568|NCT03831282||
713569|NCT03830307|Recruitment Period was from 3/11/2019-3/29/2019|
713570|NCT03828734||
713571|NCT03828617||A total of 1718 participants were enrolled, out of which only 1710 were randomized. There were 8 participants who were enrolled (signed informed consent document) but were not randomized into the study as the randomization system had reached the pre-specified capacity.
713572|NCT03828149||
713573|NCT03827473||
713574|NCT03826914|Recruitment of study participants employed several strategies including email, flyers, and in-person presentations.|
713575|NCT03825393||
713576|NCT03825042|The recruitment period started on January 2018 and terminated on October 2018. A total of 80 subjetcs have been randomization and 78 completed the study. Each subject has been involved in the study for approximately two months. A total of 4 study visits has been performed for each subject.|"Subjects who provided written informed consent have been subjected to the screening assessments. Subjects who met all inclusion criteria and none of the exclusion criteria have been eligible for the study and have proceeded with the randomization visit after 7 days.
~No wash-out or run-in period was used in this study. 8"
713577|NCT03824912||
713578|NCT03824236||
713579|NCT03823937||
713580|NCT03822884||
713581|NCT03822182|Enrollment was between November 2018 and January 2020 and inclusive of all patients with a torn rotator cuff in the clinical practice of the PI|A total of 78 patients were enrolled. 1 patient was excluded after inspect report showing current narcotic use. 1 patient was excluded for failure to submit data postoperatively.
713583|NCT03821259||The study recruited an opportunistic sample of suitable participants who were identified and initially approached about the study by a psychologist involved in their care. Consequently no participants were excluded following their enrolment in the study.
713584|NCT03820544||
713585|NCT03820258|Participants were enrolled at study sites in Europe. The first participant was screened on 28 January 2019. The last study visit occurred on 19 February 2020.|The study was terminated because EMA granted Gilead a waiver for SOF/VEL/VOX in children less than 12 years old. Cohorts 2 and 3 were not enrolled. As per the protocol, participants could have received 8 or 12 weeks of treatment, depending on their prior treatment and disease status, however all participants received treatment for 8 weeks.
713586|NCT03819491||
713587|NCT03818815||
713588|NCT03817879||
713589|NCT03817775||
713590|NCT03816761|The trial was conducted at one site in the United States.|
713591|NCT03816696|This was an open-label, fixed-sequence, two-way drug interaction and 3-period study. Participants received treatment A- dolutegravir 50 milligram (mg) in Period 1; treatment B- GSK3640254 200 mg in Period 2 and treatment C- dolutegravir 50 mg and GSK3640254 200 mg in Period 3.|A total of 30 participants were screened, of which 14 were screening failures. Hence, 16 participants were enrolled in this study. This study was conducted at a single center in the United States.
713592|NCT03815240|The study took place at the Clinical Research Center for Hair and Skin Science in Berlin, Germany from January 2019 to July 2019 and involved 12 healthy female volunteers|
713593|NCT03813719|Consective patients attending Rapid access Gynaecology Clinic for the first time, with suspected endometrial cancer between July 2018 and April 2019|
713594|NCT03812510|In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.|In the A-101-WART-303 study, subjects will be followed every 6 weeks to assess for a recurrence or development of new common warts. If a recurrence occurs or a new wart develops these subjects may return to the site to receive A-101 Topical Solution 45% twice a week for an additional treatment cycle of 8 weeks.
713595|NCT03812328||
713596|NCT03811093|The Trial recruitment period had a start date of January 14th and ended on January 19th 2019. (A total of 6 days) All participant recruitment and interviews were conducted at the Cross Chiropractic Center in Hixson, TN.|
713597|NCT03810235||3 participants delivered prior to randomization, leaving 63 participants to start the trial
713598|NCT03810014|The study was carried out in a random sample of twelve retail outlets in two sub-counties of rural western Kenya. Potential participants were approached by the research assistants as they sought services at the outlets. Participants were then offered a scratch card with masked arm assignment, which randomized them to one of four study arms in a 1:1:1:1 ratio, each arm with a different combination of two different RDT prices and two different conditional ACT prices using a 2x2 factorial design.|
713599|NCT03809910|The study was conducted at single center in Canada. A total of 40 participants were screened, of whom 39 were randomized for treatment and 1 withdrew consent prior to randomization.|Participants received 4 treatments in 3 periods: 1. Prototype power toothbrush (PTB) in 'Gumline' mode, 2. Prototype PTB in 'Combined' mode ('Gumline' mode followed by 'Interdental' mode), 3. Reference manual toothbrush (MTB), 4. Reference PTB
713600|NCT03809611||
713601|NCT03809182|The patients were recruited at the Pontifical Catholic University Hospital between 2012 and 2013. Twenty patients were assigned to each arm to allow some dropouts. Nonetheless, every randomized patient included in the study was analyzed at the end of it (intention to treat analysis).|No patient was excluded from the study after being assigned to one arm/group.
713602|NCT03809104|Older adults aged more than 60 and lived in the nursing home or went to daycare center regularly in rural southern Taiwan were recruited for screening.All the residents with sufficient cognitive function and physical fitness to perform training that lasts for 30 minutes and meeting the criteria of sarcopenia by AWGS.|A total of 43 participants were recruited for VR-REH. Among them, 40 patients completed the study and 3 patients withdrew during the study period (2 dropped out during the visit at 4 weeks due to hospitalization and 1 withdrew at 8 weeks due to case-closed from daycare center).
713603|NCT03808688|A total of 261 subjects were enrolled across 22 investigational sites and 260 treated.|The enrolled population includes all subjects who signed ICF. One subject enrolled but withdrew consent before study drug dispensed; thus, post-baseline treatment is unavailable. Participant Flow data represents ITT population. Clarification of enrolled (n= 261) vs treated (n=260) subjects is provided in Recruitment & Pre-assignment sections.
713604|NCT03808493|Participants took part in the study at 1 investigative site in Japan from 30 January 2019 to 12 March 2019.|Healthy Japanese male participants were enrolled in 1 of the 2 treatment sequences to receive TAK-438 OD 20 milligram (mg) or TAK-438 20 mg with or without water in Study 1, and TAK-438 OD 20 mg or TAK-438 20 mg with water in Study 2. Study was completed with Pilot study since results from interim analysis satisfied the criteria of bioequivalence.
713605|NCT03808298||
713606|NCT03807739|Screening period: Day -28 to Day 2|
713607|NCT03807700|Participants were recruited from a single center in Canada. A total of 119 participants were screened, all of which were enrolled and randomized into the study.|Participants were allocated to randomized treatment in 2 different arms- experimental adhesive group and no adhesive group.
713608|NCT03807544||
713609|NCT03807245|Healthy female participants aged 18 to 40 years were recruited in a Phase 1 unit from January 2019 and the study was completed by October 2019.|
713610|NCT03807089||89 subjects were excluded (poor bowel preparation [n = 45], prior colonic resection [n = 3], difficult first insertion [n=45], not over 40 [n = 1], no history of adenomatous colorectal polyps [n = 1], device related reasons [n = 1])
713611|NCT03806790||
713612|NCT03806270||
713613|NCT03805971||
713614|NCT03805672|Patients 18 years or older who were admitted to the trauma or other surgical service and diagnosed during their hospital admission with an isolated distal DVT were invited to participate in the study.|
713615|NCT03804918||
718787|NCT02711306||
713616|NCT03804710|All participants were enrolled at one center in Germany.|A total 174 participants were screened, out of which 158 participants were enrolled, 149 participants were randomized and 25 participants not randomized. Out of 149 randomized participants, 7 participants did not completed study because 3 participants experienced adverse event, 3 participants withdrew consent and 1 participant due to other reason.
713617|NCT03803085||
713618|NCT03802864||
713619|NCT03802565||
713620|NCT03802344|First Subject First Visit: 12-Dec-2018. Last Subject Last Visit: 02-Oct-2019.|"Prior to randomization, the subject entered a washout period (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The washout/screening period could last for up to 30 days, depending on which disallowed treatments the subject received.
~498 subjects signed the Informed consent form, 490 subjects were randomized and randomly assigned into 3 treatment groups (MC2-01 cream, active comparator, MC2-01 vehicle)."
713621|NCT03801148|Participants took part in the study at 1 investigative site in the United States from 10 January 2019 to 09 April 2019.|Healthy participants were enrolled in this 2-part and 2-way crossover study to receive dexlansoprazole 30 milligram (mg) capsules manufactured by Takeda GmbH Plant Oranienburg (TOB) and 30 mg capsules manufactured by Takeda Pharmaceutical Company Ltd. (TPC) in Part 1 and dexlansoprazole 60 mg capsules by TOB and 60 mg capsules by TPC in Part 2.
713622|NCT03801044|All peritoneal dialysis patients in Sisli Hamidiye Etfal Training and Research Hospital, Nephrology Outpatient Clinic, Istanbul, Turkey have been invited to the study between May and September 2018.|Total 23 patients accepted to participate in the study, but two of them were excluded because of immobility and not being capable of proceeding with the diagnostic tests
713623|NCT03800030||
713624|NCT03799614||
713625|NCT03799484||
713626|NCT03799211||
713627|NCT03796260||
713628|NCT03796182||A total of 12 healthy participants were enrolled in the study and 6 participants were assigned in each of the 2 treatment sequences, all receiving study treatment.
713629|NCT03796013||
713630|NCT03795753||
713631|NCT03794024||
713632|NCT03793751||
713633|NCT03793556|"A first specialist visit was performed by an ENT as per clinical practice based on patient's symptoms.
~Patients sent by the ENT should not have been pre-treated with PPIs and/or medical devices and/or similar products. The diagnosis was confirmed by the Gastroenterologist Investigator who recruited patients."|In this phase of the study, 72 patients were enrolled. One patient withdrew the informed consent and was excluded from the study before randomization.
713634|NCT03793010|The recruitment period for this study was from December 2018 until August 2019. The patients were enrolled at medical clinics.|
713635|NCT03792672|Participants took part in the study at 1 investigative site in Netherlands from 11 February 2019 to 18 June 2019.|Healthy participants were enrolled in 1 of the 6 treatment sequences of this 3-period crossover study to receive TAK 653 0.5 milligram (mg) (Low dose), TAK-653 6 mg (high dose), placebo in Treatment Periods 1 to 3, and ketamine 0.5 milligram per kilogram (mg/kg) in an open label treatment Period 4.
713636|NCT03791489||
713637|NCT03790917||
713638|NCT03790306||
713639|NCT03789474|The study was conducted from January 2017 to July 2018 at ALL INDIA INSTITUTE OF MEDICAL SCIENCES,RISHIKESH,UTTARAKHAND ,INDIA.|
713640|NCT03789175|This is a one-subject study so there are no recruitment or screening of other subjects.|
713641|NCT03787472|A total of 45 subjects were enrolled in this study and all 45 subjects were randomly assigned to one of the two lens sequences and completed the study. 3 subjects were excluded from analysis and 42 were included in Per-Protocol Population.|
713642|NCT03787212|A total of 4 subjects were enrolled into this study prior to its termination. This study was terminated early by the sponsor due to a warning letter from the FDA regarding non-compliance to 21 CFR part 820.|
713643|NCT03786744||
713644|NCT03786718||Of the 69 enrolled participants, 67 completed the baseline questionnaire and were with given access to the intervention. Two participants never completed the baseline questionnaire despite reminders and therefore did not receive access to the intervention and were withdrawn.
713645|NCT03785548||
713646|NCT03784898|The study was conducted at a single site in the United States. A total of 14 participants were screened between 8 February 2019 to 11 December 2019, of which,1 participant was screen failure. Screen failures was mainly due to inclusion criteria not met.|A total of 13 participants were enrolled in the study.
713647|NCT03784001||
713648|NCT03783780||
713649|NCT03783039|Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until hospital discharge and requested to attend a visit at 30 (+14) days post surgery and at 6 months (+/- 30 days) either at the hospital or via telephone.|Subjects required to meet pre-defined inclusion/exclusion criteria prior to receiving study product. Subjects required to have an appropriate mild or moderate target bleeding site (TBS) identified intra-operatively. Subjects excluded if the TBS was where silver nitrate or any other escharotic chemicals were applied, was in, around, or in proximity to foramina in bone, areas of bony confine.
713650|NCT03782571|A total of 34 subjects were enrolled into the study. Of the enrolled 9 subjects did not meet the eligibility criteria. 22 subjects completed the study and 3 subjects were discontinued from the study.|Subjects were randomized to 1 of 4 unique lens sequences.
713651|NCT03782233||
713652|NCT03782181||
713653|NCT03781375|This study was conducted at 7 centers in the United States. The study consisted of a 6-month double-blind treatment period followed by a 6-month open-label period where all participants received etanercept + methotrexate. Early transition to open-label treatment was allowed after 2 months of blinded treatment, for disease flare or lack of response.|Participants were randomized equally into 1 of 2 treatments for the double-blind portion of the study. Randomization was stratified by route of methotrexate administration (oral [PO] vs subcutaneous [SC]) prior to randomization.
713809|NCT03697993|Participants were males and non-pregnant females aged >=18 years and diagnosed with complicated urinary tract infections (cUTIs) without bacteremia with a uropathogen. Participants were enrolled between 14NOV2018 and 03OCT2019.|
713654|NCT03780959|Participants were enrolled at 9 sites in the United States and Canada. The study consisted of an open-label treatment period (part 1) where all participants received 0.4 mg etanercept twice weekly for 3 months, followed by a randomized double-blind treatment period (part 2).|At the end of part 1 participants with disease response were randomized to part 2, with stratification according to study center and number of active joints (≤ 2 vs. > 2) at the end of month 3.
713655|NCT03780400|Participants with symptomatic, physician diagnosed knee or hip osteoarthritis (OA) were recruited from participating primary care providers in 3 University of North Carolina clinics between March 2019 and July 2019. The first participant was enrolled on March 21, 2019 and the last participant was enrolled on July 3, 2019.|
713656|NCT03780010|medical clinic|
713657|NCT03779724|This prospective randomized controlled trial aimed to recruit 50 patients with multiple sclerosis from the physical medicine and rehabilitation clinic of Ankara Training and Research Hospital, Health Sciences University, Ankara, Turkey.|
713658|NCT03779503||
713659|NCT03778190||
713660|NCT03777865||The study was conducted in 1 country from 14 December 2018 to 17 April 2019. A total of 100 participants were enrolled.
713661|NCT03776175||
713662|NCT03774745||
713663|NCT03774576|Healthy male and female participants between 18 and 55 years old. Female participants were women of non-childbearing potential (WONCBP).|
713664|NCT03773133|This phase I/II, multicenter, open-label single-arm study of 177Lu-satoreotide tetraxetan therapy with companion diagnostic imaging Gallium-68 (68Ga)-satoreotide trizoxetan (formerly 68Ga-OPS202) positron emission tomography (PET)/computed tomography (CT) was terminated early on 20 November 2019 due to unsuccessful screening.|Overall, 9 subjects were enrolled of which 8 received the screening investigational imaging product (IIP) 68Ga-satoreotide trizoxetan and 1 did not due to consent withdrawn by subject. None of the subjects received the therapeutic investigational radiopharmaceutical product (IRPP), 177Lu-satoreotide tetraxetan.
713665|NCT03772522|Recruitment took place between March, 2018 and September, 2018. Participants were collaboratively recruited by our community partner Covenant House Toronto, who referred youth to our research team.|Although out recruitment goal was 26 youth, we exceeded that goal by recruiting 27 youth.
713666|NCT03772327|Recruitment occurred primarily from the clinic population receiving care for HIV at New York Presbyterian Hospital Center for Special Studies located in New York City. A total of 24 and 42 participants were recruited from the Upper East Side and Chelsea locations respectively from May 2015 to August 2018.|67 were screened for the study and 4 did not enroll because: 1 elected not to participate given excellent adherence to medications, 1 was ineligible after a switch off a tenofovir containing regimen, 1 did not come to the enrollment appointment, and 1 did not provide consent.
713667|NCT03771560||
713668|NCT03771274||
713669|NCT03769207|Participants who received an irregular pulse notification or who had an AF classification on the ECG app and then called the sponsor's customer support were invited to download the study app and enroll. They had a remote study visit, were sent an ECG patch to wear and return for analysis, and had a second remote visit to review the findings.|
713670|NCT03768856||
713671|NCT03767894||
713672|NCT03767062||
713673|NCT03766646||
713674|NCT03766373||
713675|NCT03766165||
713676|NCT03765996|Patients enrolled in the study between 2012 and 2014.|
713677|NCT03765502|Trained Users were recruited alongside a participant with diabetes (PWD) with whom they were familiar. They were given a level of training intended to mimic that of a real-life caregiver on both devices: glucagon emergency kit (GEK) and nasal glucagon (NG). Untrained Users who have limited knowledge of severe hypoglycemia did not receive training.|Trained users participated in Part A and untrained users participated in Part B.
713678|NCT03765164||
713679|NCT03765138||
713680|NCT03764813|Parents of neonates with birth weight < 1000 gr and/or postmenstrual age < 30 weeks consecutively admitted to the intensive neonatal unit of Fondazione Poiliclinico Gemelli IRCCS were informed about the study and asked to paricipate.|Among 29 couples, 25 accepted to participate and overall 25 patients were enrolled.
713681|NCT03764449|The study was conducted at 1 site in the Netherlands.|Participants in this study included healthy volunteers.
713682|NCT03763058|Patients were recruited in Groupe Hospitalier Sud Réunion between 3-15 December 2018.|Thirty-two patients were screened but not enrolled and assigned to music intervention as they did not fill the inclusion/exclusion criteria.
713683|NCT03762668|This study was conducted at 5 investigative sites located in the United States.|Of the 62 subjects enrolled, 2 were exited as screen failures prior to randomization. This reporting group includes all randomized and exposed subjects (60).
713684|NCT03762200|Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until hospital discharge and requested to attend a visit at 30 (+14) days post surgery and at 6 months (+/- 30 days) either at the hospital or via telephone.|Subjects required to meet pre-defined inclusion/exclusion criteria prior to receiving study product. Subjects required to have an appropriate mild or moderate target bleeding site (TBS) identified intra-operatively. Subjects excluded if the TBS was where silver nitrate or any other escharotic chemicals were applied, was in, around, or in proximity to foramina in bone, areas of bony confine or where plugging of the urethra, ureter or a catheter was possible by study product.
713685|NCT03761368|Patients aged over 18 years presented with stable angina pectoris, admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz and scheduled for elective CA with follow-up PCI.|
713686|NCT03760640||
713687|NCT03760510||
713688|NCT03760250||
713689|NCT03760146||
713690|NCT03759600|Participants took part in the study at 17 investigative sites in Japan from 26 December 2018 to data cut-off: 01 July 2019.|Female participants with a diagnosis of advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based therapy were enrolled to receive niraparib 300 mg in this study.
713918|NCT03644108|This was a single-centre study.|A total of 30 subjects were screened for the study; All 30 subjects were included single-period.
713691|NCT03759587|Participants took part in the study at 27 investigative sites in Japan from 28 Dec 2018 up to Data cut-off: 17 Mar 2019. The study is ongoing.|Participants with a diagnosis of with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, who had achieved complete response (CR) or partial response (PR) in the last chemotherapy containing platinum-based anticancer agents were enrolled to received niraparib 300 mg in this study.
713692|NCT03759340||
713693|NCT03758365|First Subject First Visit: 07-Nov-2018. Last Subject Last Visit: 23-Nov-2018|"The study consist of a screening period up to 15 day prior to randomization, a test period and a follow-up period.
~The study design is a within subject evaluation of the vasoconstriction properties of MC2-01 cream compared with vehicle cream and 5 other corticosteroids. All subjects received therefore a single treatment with all 7 products."
713694|NCT03757988||
713695|NCT03757234||
713696|NCT03757039|Subjects were enrolled at investigative sites located in the United States (1) and United Kingdom (1).|Of the 42 enrolled, 1 subject was exited from the study as a screen failure prior to randomization. This reporting group includes all randomized/assigned subjects (41).
713697|NCT03756506||dlk
713698|NCT03756038||
713699|NCT03755882|A total of 46 subjects were enrolled into this study. Of those enrolled 45 were dispensed at least 1 study lens. Of those dispensed, 41 subjects completed the study while 4 were discontinued.|
713700|NCT03754556|This study was a retrospective cohort study, using the data from three health care systems: Kaiser Permanente Northern California (KPNC), Kaiser Permanente Southern California (KPSC), Kaiser Permanente Washington (KPWA) and one research institute with access to a health information exchange, Regenstrief Institute (RI)|Between 01 January 2001 and 30 April 2018, 326658 participants were identified: 322898 participants with intrauterine device (IUD) type available and 94817 participants with breastfeeding status available (and IUD insertion within 12 months postpartum)
713701|NCT03753113||
713702|NCT03752567|Enrollment took place in the first 15 days of the operating period (November 1, 2018 - October 31, 2019). The patients were enrolled at the only experimentation center represented by La Regina pharmacy, a community pharmacy in a small rural center in southern Italy.|None of the enrolled patients were excluded from the ongoing trial. All patients completed the entire observation period.
713703|NCT03752528|All investigators sites were in the U.S.|54 subjects were screened. One did not meet eligibility criteria.
713704|NCT03752151|Subjects were considered enrolled when they signed informed consent Subjects were enrolled between 22 January 2019 and 14 June 2019 at 12 study centers in 8 countries|Following enrollment, the MARVEL 2 algorithm was downloaded into the subject's implanted Micra pacemaker. Following download subjects were programmed to MARVEL 2 Algorithm monitor mode followed by MARVEL 2 adaptive mode. Two subjects exited prior to MARVEL 2 download; one did not meet the study inclusion/exclusion and one withdrew consent.
713705|NCT03751280|This study was conducted at 6 centers in the USA.|The eligible subjects were randomized in 1:1 ratio to receive either PEAR-004 or sham.
713706|NCT03751020|Participants were specifically recruited through tailored advertising on geo-targeted websites; bulletin boards and listservs of local colleges; in-person announcement and flyers at local businesses, community events, and the gay-straight alliances of area schools. Participants completed a brief online survey to confirm eligibility.|"Participants completed a brief online survey to confirm eligibility, defined as:
~age 18 -29; identifying as sexual minority; currently living in one of the eligible counties; and having daily personal Internet access. Participants emailed a photo of an identification card(e.g. a driver's license), as proof of age. 108 people were randomized."
713707|NCT03748979|Participants took part in the study at 3 investigative sites in Japan from 21 November 2018 to 24 October 2019.|Healthy participants were enrolled in Part A and A' (exploratory), NT1 in Part B and NT2 in Part C, to receive TAK-925 multiple rising dose of 44 mg (milligram), 112 mg,180 mg or placebo in Part A, 11 mg, 44 mg or placebo in Part B, multiple dose of TAK-925 44 mg, 112 mg or placebo in Part C.
713708|NCT03748758||
713709|NCT03746405||Across the 25 enrolled participants, 7 were excluded after the first visit for different reasons such as: contraindications, too high resting motor threshold or technical difficulties
713710|NCT03745937|The study was conducted in Germany between 07Jan2019 and 28May2019.|A total of 20 participants were randomized to the study.
713711|NCT03745222|One participant was enrolled in the United States before the study was terminated.|
713712|NCT03745092||
713713|NCT03744780||
713714|NCT03742973||Zero participants reported in cohort A due to protection of personal identifiable information based on enrollment futility and cohort B is not reported due to early study termination based on enrollment futility.
713715|NCT03742440||
713716|NCT03742271|A total of 129 subjects were enrolled in this study. Of those enrolled, 127 subjects were assigned and dispensed the Test lens while, 2 subjects failed to meet all eligibility criteria. Of those dispensed, 115 subjects completed the study while, 12 subjects were discontinued from the study.|
713717|NCT03742154||
713718|NCT03741725||
713719|NCT03741062||
713720|NCT03740659|"Study Period:
~Date of first enrolment: 4 September 2018
~Date study finalized (last patient last visit): 6 December 2018
~Study centres:
~U.O. Oculistica Universitaria, Azienda Ospedaliera Universitaria Pisana, Presidio Ospedaliero di Cisanello, Pisa;
~Clinica Oculistica, Presidio Ospedale San Paolo, Milan."|Planned sample size n.120; randomized patients n.125; screened patients n.133 (1 patient screened for both eyes).
713721|NCT03740152||
713722|NCT03739866|Participants were enrolled at study sites in the United States. The first participant was screened on 26 November 2018. The last study visit occurred on 15 June 2020.|89 participants were screened. Data submitted represent analysis performed on data collected by the Primary Completion Date, November 2019, and available additional data collected through June 2020. Complete data will be submitted in June 2021.
713723|NCT03739528|"Study period:
~Date of first enrolment: 03.09.2018
~Date study finalized (LPLV): 19.12.2018
~Study centers:
~42 centers in Italy
~4 centers in Spain
~4 centers in Russia
~1 center in Germany"|Planned sample size n.800; randomized patients n.808; screened patients n.863
713724|NCT03739242||
713725|NCT03738865||132 subjects were randomized, however 1 subject withdrew prior to dosing, therefore 131 subjects received study drug.
718935|NCT02696226||
713726|NCT03738475|Participants took part in the study at 6 investigative sites in the United States from 11 November 2018 to 22 July 2019.|Participants diagnosed with celiac disease (CD) were enrolled in a 1:1 ratio in one of two treatment groups: Tolerogenic Immune Modifying Particles - Gliadin (TIMP-GLIA) or Placebo.
713727|NCT03738020||spilt-face design
713728|NCT03736031|Participants were enrolled at an academic medical center between May 8, 2018 and August 15, 2019.|Participant enrollment and randomization occured at the same time. There were no enrolled participants excluded from the study before assignment to groups.
713729|NCT03735862|A consecutive cohort of patients who underwent a hiatal hernia repair between 1 Nov 2015 and 1 Mar 2017 at the principle investigator's private practice were identified. Patients were contacted by phone and asked if they were willing to participate. If so they were consented and enrolled.|12 patients declined participation or could not be contacted. These were included in the baseline analysis.
713730|NCT03734822||
713731|NCT03733899|A total of 22 subjects were enrolled in this study. Of those enrolled, 20 were dispensed at least one study lens while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 17 completed the study while 3 subjects were discontinued.|
713732|NCT03733470||Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications leaving 8NS and 11SS subjects.
713733|NCT03733301|Participants who completed the 16-week treatment period had an option to enter extension study JAHN (NCT03334435).|
713734|NCT03730116||
713735|NCT03730103||Subjects were excluded: (2) case start-times after 1:00 p.m., (1) case aborted, (1) approach changed to vaginal, (1) patient withdrew.
713736|NCT03729960||
713737|NCT03728790|Subjects were recruited from the inpatient postpartum service after delivery. Recruitment began on November 9, 2018. The last participant was recruited on July 10, 2019.|426 women with hypertension were assessed for eligibility. 123 women were excluded: 1 was under 18 years old, 49 resided outside of New York State, 22 received care at a non-participating office, 48 were planning on following up at another institution, 2 spoke a language other than English or Spanish and 1 was unable to use the tablet. 90 declined.
713738|NCT03728140||
713739|NCT03727854||
713740|NCT03727425||
713741|NCT03727373||
713742|NCT03726996||
713743|NCT03726164||
713744|NCT03725982|Volunteering participants were recruited via the collaborating investigators and by means of announcement e-mails to employees and students of the University and Hospital of Tübingen.|39 volunteering participants were recruited, of which 2 were excluded from the study prior to the measurement due to a too high BMI (> 30 kg/m2). A 3rd participant was excluded because he was the first that was measured and we had to adjust a few things to the measurement afterwards.
713745|NCT03725098||One additional subject was enrolled due to a delay in the reporting function of the electronic database used for the study. This additional subject is not anticipated to affect the analyses or ethical conduct of the study, as all subjects were treated on-label for an approved device in this post-market study
713746|NCT03725085|This is a multicentric study conducted in 9 study centres across 7 cities in India.|A total of 554 subjects were screened, 552 subjects enrolled and 550 of them completed the study.
713747|NCT03724981||Injections with the 2 injection devices were performed on a practice pad.
713748|NCT03724877|Base cohort consisted participants with ChronicObstructivePulmonaryDisease(COPD) who subsequently received at least one prescription for a long-acting bronchodilator, either Long-Acting Beta2-Agonist(LABA) or long-acting MuscarinicAntagonists(LAMA), or for inhaled corticosteroid(ICS), alone or in combination, from 1January2002 until 31December2015.|Population-based incident new-user cohort design with high-dimensional time-conditional propensity score matching. The study cohort was formed from the base cohort using an incident new-user cohort design with time-conditional propensity scores.
713749|NCT03724253|This study was conducted at 3 centers in 2 countries: Austria (1) and France (2).|A total of 50 subjects were planned for the study (10 subjects for the dosimetry group and 40 subjects for the non dosimetry group). In total, 22 subjects were screened for eligibility and 19 subjects were enrolled (2 subjects in the dosimetry group and 17 subjects in the non dosimetry group).
713750|NCT03723980|"Start of recruitment : 1st october 2017 End of Recruitment: 24th april 2018
~location: Pakistan; Karachi; Dow-International dental college, Operative Dentistry; out-patient department."|
713751|NCT03723603||
713752|NCT03722810||More students agreed to participate in the study than we had expected.
713753|NCT03722784||
713754|NCT03722446|Patients in labor requesting epidural analgesia for an expected vaginal delivery.|Participants were excluded if there was a fetal loss involved.
713755|NCT03722264|12 participants were enrolled with all participants receiving each treatment|
713756|NCT03722030||
713757|NCT03721549||
713758|NCT03720938|Four primary public schools among 14 in the central schools of Bolu region were randomly selected. In January to February of year 2013, all children (n=1300) from grades III,IV,V and VI were given froms for participation.Children positively responded to informed consent forms (n=918) were accepted as eligible for the study.|"The discrepancy between the enrolled (918) and assigned (n=106) numbers of children could be attributed to strict inclusion and exclusion criteria, and particularly to dropped out children due to technological preoocupation and physical inactivity as well as problems interfering physical activity and self-perception."
713759|NCT03720847|"Recruitment occurred between November 15, 2016 and August 12, 2017. All participants were recruited via social media advertisements to participate in a study on the biology of stress, depression, and suicidal thoughts. All participants were enrolled at the single site for the study: UNC Chapel Hill Psychiatry Department laboratories."|
713760|NCT03720119|Patients were recruited from January 27, 2015 to March 05, 2018 in three Italian hospitals in Pisa and Trieste|
713761|NCT03719885||
713762|NCT03719677||
713763|NCT03719300|Eligible patients were patients with High Risk Non Muscle Invasive Bladder Cancer whose disease was unresponsive to BCG. It was planned to enroll and treat 140 patients (N=140), of which 70 to 100 were estimated to have carcinoma in situ (CIS) (with or without papillary disease).|
713764|NCT03718455||
713765|NCT03718143||
713766|NCT03718000||
718936|NCT02696200||
713767|NCT03717064|This study recruited healthy adult participants at one site in the United States.|This study had two periods. Period 1: Participants received a single dose of pitavastatin, followed by a washout period of 7-21 days. Period 2: Participants received a single dose of pitavastatin along with a twice-daily dose of RO7049389.
713768|NCT03716050||
713769|NCT03716024||
713770|NCT03715803||
713771|NCT03715530||
713772|NCT03715452||
713773|NCT03715426|Participants were recruited from the mandatory primary prevention program, Relationship Remix, offered to all incoming students at the University of Michigan. We specifically recruited from October 21, 2018 - November 11, 2018 from Alice Lloyd Residence Hall (control) and Couzens and Fletcher Residence Halls (intervention).|In the MKit WebApp Intervention group, 1 potential participant did not complete the baseline survey. In the Standard of Care group, 4 potential participants did not complete the baseline survey. All of these potential participants were therefore not considered enrolled for the purposes of outcome analyses.
713774|NCT03714672|The first participant was enrolled on 26 August 2017.|A total of 1151 participants signed an informed consent form, 829 participants were allocated to treatment. Of the 829 allocated participants, 3 were not treated (1 each in the Diclofenac 50, Tramadol 50, and Tramadol/Diclofenac 25/25 treatment arms) and were not included in the Safety Set (N=826).
713775|NCT03714659||
713776|NCT03712917||
713777|NCT03710577|Volunteers were recruited from students, faculty, and staff at the University of Wisconsin - Madison to participate in this study.|Volunteer eligibility was determined through a preliminary phone screen, participants were randomly assigned to receive the experimental task (Yoga) or the control task (quiet rest) first. Participants will then cross over 2-5 days after their first task to act as their own controls.
713778|NCT03710083||72 subjects consented and enrolled in the overall study. Of the 72, 3 subjects failed screening, 3 subjects didn't utilize any Guardian™ Sensor (3) , 66 subjects utilized Guardian™ Sensor (3) and were considered to have started in the study.
713779|NCT03709823||
713780|NCT03709810|Participants were recruited from a single center in the United States. A total of 53 participants were screened, of which 49 were enrolled. 48 participants were randomized and completed the study.|Participants allocated to either intervention A(experimental test adhesive)or B(no adhesive)in period1. In period2,alternative sequence was assigned(B or A)in a crossover manner.Each period consisted of 1day testing(single use of experimental test product)with at least2days between adjacent treatment visits to recover from mastication procedures.
713781|NCT03709654||
713782|NCT03709602|32 participants were recruited for the qualitative portion of the study to participate in interviews (n = 16 parents, n = 16 adolescents)|Cohort of Adolescents from electronic health record group were reviewed retrospectively from January 1, 2017- February 28, 2019. Enrollment of parents and adolescents (n = 32) began on the start date of January 7, 2019.
713783|NCT03709576|Subjects were recruited from the Penn State Milton S. Hershey Medical Center from 18 July 2018 through 17 October 2019|One subject was excluded due to progression of disease prior to enrollment
713784|NCT03708770|First subject enrolled July 27, 2015 and last subject enrolled November 8, 2016. Last subject follow-up was June 19, 2017.|
713785|NCT03708744||"4-way crossover, each subject randomized to receive A, B, C, and D in one of four sequences.
~A: M207 3.8 mg, two 1.9 mg patches, 30 min, upper arm B: M207 3.8 mg, two 1.9 mg patches, 30 min, thigh C: M207 3.8 mg, two 1.9 mg patches, 1 hr, upper arm D: Intranasal zolmitriptan 2.5 mg One subject randomized to CADB was given ABCD."
713786|NCT03708562|The EverlinQ Endovascular Access Systems Enhancements (EASE-2) study began enrollment on October 5th 2017 and the last patient was enrolled on May 23rd 2018.|
713787|NCT03708211|Participants took part in the study at investigative sites in the Netherlands from 28 March 2019 to 03 December 2019.|Participants with advanced solid tumors were enrolled in 2-part cross-over design study to receive 1 of 2 treatment sequences in Part 1: TAK-931 80 mg PIC + TAK-931 80 mg tablet (Sequence A) or TAK-931 80 mg tablet + TAK-931 80 mg PIC (Sequence B). Part 2 of the study was not conducted due to the business decision, which was unrelated to safety.
713788|NCT03707912||
713789|NCT03707821|A total of 253 subjects were enrolled into this study. Of those 2 subjects failed to meet all eligibility criteria and 251 subjects were dispensed a study lens. of the dispensed subjects 248 completed the study while 3 subjects were discontinued.|
713790|NCT03707587||
713791|NCT03707522|College students recruited via e-mail|
713792|NCT03706469|Participants took part in the study at 1 investigative site in the United States from 18 October 2018 to 22 December 2018.|Healthy participants were enrolled and randomized in one of the 4 treatment sequences to receive TAK-831.
713793|NCT03706313||
713794|NCT03705793||"Mometasone Furoate Nasal Irrigation Arm 3 participants lost to follow-up 2 participants withdrew
~Mometasone Nasal Spray Arm 4 participants lost to follow-up
~1 participant withdrew
~While 53 participants were initially enrolled, a total of 7 participants were lost to follow-up and 3 participants withdrew. Thus, the total number of participants who completed the study was 43."
713795|NCT03705494||
713796|NCT03705481||
713797|NCT03704467|First participant signed informed consent: 04 Mar 2019, Last participant last visit: 06 Nov 2019.|This study was planned to be conducted in 2 parts; Part A was the safety run-in part and Part 2 was the randomized controlled part. However, after completing Part A and confirming the safe combination dose, the sponsor decided not to conduct Part B.
713798|NCT03704376||125 were enrolled, but 39 were excluded because they ended up receiving a different type of graft.
713799|NCT03704194||
713800|NCT03703466||Study completers are participants who completed 3 cycles (28 days cycle)
713801|NCT03702608||
713802|NCT03702166||
713803|NCT03701061||
713804|NCT03700671||
713805|NCT03700385|A total of 40 subjects consented and were treated.|A total of 40 patients were enrolled (signed informed consent) and 40 subjects were treated at two (2) sites in Europe.
713806|NCT03698591|Subjects were recruited from 11/1/18 until 5/17/19. Subjects were recruited and screened from the Duke University Brain Imaging Analysis Center (BIAC) research participant pool as well as from e-flyers on Duke University's electronic community bulletin board (DukeList).|
713807|NCT03698331||
713810|NCT03697551|Female subjects with newly diagnosed breast cancer who had a somatostatin receptor subtype 2 (sstr2) positive lesion were recruited to this study from 22 October 2018, and the last subject last visit was on 6 February 2019. The study was terminated early on 9 August 2019.|Six subjects were screened and 4 subjects were eligible to receive gallium-68 (68Ga)-satoreotide trizoxetan (formerly 68Ga-OPS202) as a sstr2 positive positron emission tomography (PET) imaging agent. The screening period was up to 14 days prior to the 68Ga-satoreotide trizoxetan administration on Day 1, with a follow-up visit at Day 14.
713811|NCT03697252|The study was conducted in 12 study centers in North America.|A total of 250 participants were screened, 182 were randomized, and 145 participants completed the study.
713812|NCT03697122||
713813|NCT03697083||
713814|NCT03696589||
713815|NCT03695913||
713816|NCT03695094|The study started to enroll patients in September 2018 and concluded in May 2019.|"The study included a Screening Period (Day -28 to Day -2), a Baseline Visit (Day -1), a Treatment Period (Day 1 to Day 12) and a Safety Follow-Up Period Day (13 to Day 20±1).
~Participant Flow refers to the Full Analysis Set."
713817|NCT03694925||
713818|NCT03694821||
713819|NCT03693989||
713820|NCT03693950||
713821|NCT03693937||
713822|NCT03693625|The study was conducted at 9 centers in 1 country.|A total of 31 participants were enrolled at 9 centers.
713823|NCT03692676|This study is a cross-sectional assessment of asthma patients who initiated Spiriva Respimat, who initiated leukotriene receptor antagonist (LTRA), who received a higher dose of ICS/LABA FDC, or who switched to a new ICS/LABA FDC in asthma in the UK during the study period|All subjects were screened for eligibility to participate in trial. Subjects visited specialist site to ensure that they met all implemented inclusion criteria. Subjects meeting the exclusion criteria were excluded.
713824|NCT03691948||No significant pre-assignment study events occurred.
713825|NCT03691844|"Seven trial sites in Denmark (1 site), Czech Republic (3 sites) and the USA (3 sites).
~Trial initiation: 04-Oct-2018 Trial completion: 09-Jul-2019"|
713826|NCT03691831||
713827|NCT03689920|After subjects were enrolled, they were evaluated per study eligibility criteria. Only those who met all criteria proceeded to receive implant and randomized in the study (as applicable).|
713828|NCT03689452||
713829|NCT03688880|The study was conducted at 16 sites in 4 countries from 30 October 2018 to 04 September 2019. A total of 107 participants were enrolled of which 18 participants were screen failures. Screen failures were mainly due to inclusion criteria not met.|A Total of 89 participants were randomized and treated in the study. Assignment to arms was done in 2:1 ratio (MAR-CUTIS:Dermabond Advanced). Randomization was stratified by wound type (lacerations and incisions), skin type and age groups.
713830|NCT03688620|GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain) was administered to subjects in this study|Subjects aged <9 years in Vaccinated_Fluarix Tetra Group (Spain) who were not vaccinated against influenza in preceding seasons received 2 doses of quadrivalent seasonal influenza vaccine in this study. Subjects from other groups received only 1 dose of the vaccine. Dose 2 results correspond to only some subjects in Vaccinated_Fluarix Tetra Group.
713831|NCT03687970|This study was conducted at Washington University in St Louis School of Medicine. Participants were recruited between September 17, 2018, and September 17, 2019.|This is a case-control study. Case group: Patients with current symptoms of painful chemotherapy-induced peripheral neuropathy (CIPN) following treatment with oxaliplatin, cisplatin, paclitaxel, or docetaxel. Control group: patients who received the same chemotherapy agents, but who did not report current (or other long-term) painful CIPN.
713832|NCT03687736||
713833|NCT03687684|Participants took part in the study at single site in Japan from 09 October 2018 to 19 June 2019.|Healthy adult participants were randomized to receive TAK-831: under 3-sequential dose escalation design to the sequence of administration of A (100 mg +300 mg), B (100 mg + Placebo), and C (Placebo + 300 mg) in Cohort 1 (Japanese); single dose followed by multiple dose of TAK-831 or Placebo in Cohorts 2, 4, 5 (Japanese) and in Cohort 3 (Chinese).
713834|NCT03687450||
713835|NCT03687372||
713836|NCT03686176|This study was conducted in the pediatric emergency department (PED) at an urban, tertiary care children's hospital.|
713837|NCT03686033|Participants took part in the study at 4 investigative sites in the United States from 31 October 2018 to 18 June 2019. A total of 8 participants were screened and enrolled, of which 5 participants were randomized and treated, of which, 4 participants completed both crossover and open label treatments in the study.|The study was terminated due to safety concerns from a phase 1 study (E2082-J081-001; NCT03402178) and preclinical animal toxicity testing.
713838|NCT03685968|Patients were enrolled from the adult surgical operating rooms of 2 academic hospitals, Lyndon Baines Johnson General Hospital and Memorial Hermann Hospital - Texas Medical Center, in Houston, TX from August 2013 to December 2015.|
713839|NCT03685643||A total of 578 eligible participants (290 in the intervention and 288 in the control) participated in the study.
713840|NCT03685396|42 subjects were selected from those seeking care at the Department of oral surgery, Dental clinic G.Vogel, San Paolo hospital,Milan.|
713841|NCT03684928||
713842|NCT03684265|The trial was a randomised, two-period, two sequences, single-dose, open-label, and crossover trial in healthy male and female subjects in fasting conditions.|All subjects were screened for eligibility to participate in trial. Subjects attended specialist site to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated. In this study, 26 subjects were entered & treated.
713843|NCT03684044|A total of 363 patients received at least one dose of study treatment and were included in the analyses of safety and efficacy.|
713844|NCT03683901||Single group cohort study with random serial allocation of treatment type. All participants underwent each of the three stimulation conditions (TENS, t-NMES, no stimulation) three times in a computer-generated random sequence for each outcome measure with a 5-minute wash-out period between each stimulation.
713919|NCT03644095|This was a single-centre study.|Total 30 subjects were enrolled in the study and all 30 subjects completed the study.
713920|NCT03643692||
718937|NCT02696083||
713845|NCT03683758|Recruitment was performed through convenience sampling. Potential study participants are identified through Co-Investigator, Dr. Matt Wentzell's, prior involvement as the trainer/first aid respondent for one of the two NSGSC teams.|"Participants allocation is premeditated by team-based on the MW's regular paramedical involvement with one of the teams and therefore his ability to oversee and administer the intervention warm-up.
~Goaltenders, pregnancy, injury/illness preventing participation in performance testing, practices or games are all grounds for study exclusion."
713846|NCT03682809||
713847|NCT03681951|This was an open-label study to investigate the safety, clinical activity, pharmacokinetics, and pharmacodynamics of GSK3145095 administered alone and in combination with anticancer agents including Pembrolizumab in adult participants with selected advanced solid tumors.|Total 8 participants were included in part 1 of the study across United States. This study was terminated during Part 1 (Monotherapy dose escalation [DE]) and hence Part 2,3,4 were not conducted following an internal review of the company's current research and development portfolio.
713848|NCT03681808||
713849|NCT03681119||
713850|NCT03680105|Participants received either Rejuveinix (RJX) or saline placebo.|
713851|NCT03679975|Eleven subjects were screened for the study: Two subjects withdrew after signing informed consent but prior to any study procedure. Nine subjects were enrolled and received study medication and completed the study. There were no discontinuations.|Planned enrollment was 30 patients for a final sample size of 25 completed patients. The Sponsor decided to terminate the study after 9 completed patients (with agreement from the FDA), based on an interim analysis of the first 8 completed patients with no evidence of a harmful effect of 1 dose of 50 mg Riluzole Oral Film on swallowing function.
713852|NCT03679741|A total of 126 subjects were enrolled into this study. Of those enrolled, 120 subjects were randomized and dispensed at least one study lens. Of the dispensed subjects, 110 completed the study, while 10 subjects were discontinued.|
713853|NCT03679494||
713854|NCT03678870||
713855|NCT03678311|Recruitment was delayed in starting. Start Date 3/13/2019, End Date 4/30/2019. Recruited people with a clinical diagnosis of QT Prolongation that were not on treatment for sleep disordered breathing, chronic sleep disorders, unstable medical conditions or rapid/uncontrolled heart rate (for safety reasons).|Baseline Study 9 completed, 4 qualified to continue and receive CPAP. Zero started the 3 month follow up (CPAP treatment). Because of contract issues CPAPs were not available. Study ended 4/30/2019.
713856|NCT03677401|The study was conducted at 40 sites in US from 29 August 2018 to 06 February 2020. All psrticipants who met the study entry criteria were randomized in a 1:1 ratio to receive daily oral doses of serlopitant 5 mg or placebo.|During the screening period (4 weeks), all participants were evaluated for eligibility and chronic pruritic conditions frequently associated with Prurigo Nodularis. Participants were to complete an electronic diary (eDiary) at the Screening visit.
713857|NCT03677375||Protocol enrollment number includes screen failures and subjects that did not proceed due to time constraints
713858|NCT03677245||
713859|NCT03677089|Target enrollment was 150. 149 participants, primary care physicians, were screened from 10 ECHO Autism Hub Centers. 1 participant failed screening. 148 participants were enrolled. Screenings/enrollment occurred between September 12, 2016 and January 16, 2018. Two ECHO Autism Hub Centers were randomized to each of the 5 cohorts/clusters.|The 10 sites were randomly assigned to cohort using SAS. Each site was assigned a random number (from a uniform distribution), and the two lowest numbers were assigned to period 1, etc. through the two highest numbers assigned period 5. No blocking or stratification was used in the randomization.
713860|NCT03676803|Interested participants who responded to the approved flyers called the research site and a coordinate conducted a screening by utilizing a screening script. Initial eligibility was determined by a telephone conversation. Eligible subjects were scheduled for a screen visit.|After one week run-in period, thirty-one participants were enrolled and randomized into mixed-spices intervention group and placebo group. All have completed the two-week intervention study.
713861|NCT03675776||Total of 68 participants were screened for eligibility; 50 participants randomized to receive double-blind treatment.
713862|NCT03675685||
713863|NCT03675581|This is an open-label, 2-period, fixed-sequence, Phase I trial in order to investigate the effect of nintedanib on the pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in female patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).|All patients were screened for eligibility prior to participation in the trial. Patients attended a specialist site which ensured that they (the patients) strictly met all inclusion and none of the exclusion criteria. Patients were not to be allocated to a treatment group if any of the entry criteria were violated.
713864|NCT03675451||
713865|NCT03674177|The study was conducted at 11 centers in 3 countries: 4 in Finland, 5 in Germany and 2 in the USA.|Among 579 screened subjects in this study, 77 subjects were screen failure. 502 subjects were enrolled.
713866|NCT03673670||
713867|NCT03670537||
713868|NCT03669081||
713869|NCT03668600|Patients from RAP-MD-99, completed 1 of the rapastinel lead-in studies - RAP-MD-04, RAP-MD-05, RAP-MD-06 or RAP-MD-33.|
713870|NCT03667547||
713871|NCT03664544||
713872|NCT03663582|The study was conducted at 5 sites in Japan between 06 July 2018 (first participant first visit) and 06 August 2019 (last participant last visit).|A total of 7 participants were enrolled and received the treatment. Out of them, 6 participants completed the study.
713873|NCT03663569|This open-label self-controlled observational study over an observational period of 6 weeks (2 visits) was to investigate the potential changes in clinical control of Chronic Obstructive Pulmonary Disease (COPD) patients measured by the Clinical COPD Questionnaire (CCQ) during treatment with Spiolto® Respimat® in routine practice.|All patients were screened for eligibility prior to participation in the trial. Patients attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
713874|NCT03663179||
713921|NCT03643575|This was a single-centre study.|A total of 30 subjects entered the study, among them 27 subjects completed the study.
713922|NCT03643432||
714299|NCT03509207|3 patients were enrolled. The study was prematurely closed due to the sluggish patient recruitment and the difficult acquisition of the investigational product.|There were no Screening failures in the Course of the study.
713875|NCT03663101|This Phase II proof-of-concept study was conducted at single investigational site in the United Kingdom between 30 October 2018 and 08 November 2019. The study consisted of two sequential parts: Part A (Pre-randomisation run-in period) and Part B (Randomised double-blind period). Part A was considered as an extended screening period.|Part A was conducted to identify participants who would potentially benefit from Dysport® injection, considered as 'responders'. Part B was a double-blind study of Dysport or placebo injection in responders from Part A. Of the 46 participants who were included in Part A, 17 were responders. Of which, 16 participants were randomised into Part B of the study.
713876|NCT03662334||All three parts (Parts 1, 2, and 3) of this exploratory study were to use a cross-over design that would maximize efficiency while minimizing sample size. Only Part 2 of this study was conducted; thus, all 14 participants were enrolled in Part 2 only.
713877|NCT03662282|Infants were recruited from a single NICU for compassionate use of Omegaven for cholestasis.|Infants were screened based on inclusion and exclusion criteria. When there was a potential candidate, an IND application is submitted to FDA.
713878|NCT03662139||
713879|NCT03661814|Participants were recruited from August 2018 - December 2018|
713880|NCT03661762||
713881|NCT03661697||
713882|NCT03660839|Study was conducted at 7 active sites in 5 countries. Total of 448 participants were screened between 11 September 2018 and 09 October 2019, of which 140 were randomized to 1 of 4 treatment arms and those who failed to meet inclusion criteria were considered as screen failure.|All eligible participants were randomized via a centralized randomization system using interactive response technology to 1 of the 4 arms in 1:1:1:1 ratio. Day 0 (drug administration day, per protocol) was considered as Day 1 for all analysis using Safety population as per Clinical Data Interchange Standards Consortium convention.
713883|NCT03660787||114 is the number of enrolled and screened participants according to the protocol, but during the screening process some people were withdrawn from the study before randomization because some of them did not meet the inclusion criteria and some withdrew the informed consent form themselves. So, the number of randomized participants is 104.
713884|NCT03660241||
713885|NCT03658889||
713886|NCT03658876||There were 197 individuals who consented to the study. These were in the observational phase. There were 184 randomisation episodes from these individuals.
713887|NCT03658811||
713888|NCT03657407|A cohort of 281 women was assessed for trial eligibility. Patients were excluded from enrollment if the patient could not be reached pre-operatively (n=47), if inclusion criteria were not met (n=67), or if participation was declined (n=106). A cohort of 61 women met criteria for trial enrollment.|From a cohort of 61 women meeting criteria for trial enrollment, individuals were excluded from study participation and randomization if the study protocol was not executed by the surgical team i.e. study medication was not ordered/administrated (n=5). 56 women underwent randomization/assignment to the study interventions.
713889|NCT03657264||
713890|NCT03657095||At the Enrollment Visit for this open-label extension (OLE) study, participants began a blinded transition from the pivotal BPS-314d-MR-PAH-302 double-blind study (NCT01908699) to this study over 4 weeks.
713891|NCT03655951||
713892|NCT03655444||
713893|NCT03655301|The study was conducted at one study center in the US, between 11-Sep-2018 (first participant first visit) and 12-Nov-2018 (last participant last visit).|A total of 50 participants signed the informed consent form, of them 37 participants were screen failures. The remaining 13 participants received the study treatment.
713894|NCT03655106||
713895|NCT03654560||
713896|NCT03654417||
713897|NCT03653429||
713898|NCT03653416|Participants enrolled from March 2018, and study conducted from June 2018 to August 2019|
713899|NCT03651856||
713900|NCT03651479||
713901|NCT03650842||
713902|NCT03650400|Six US centers recruited 11 subjects in the study.|A total of 19 subjects were screened to enroll 11 subjects in the study
713903|NCT03649867||
713904|NCT03649815||
713905|NCT03649750|This was a single-centre study.|Total Thirty-six (36) subjects were enrolled in the study among them 36 subjects completed the study.
713906|NCT03649646||
713907|NCT03649412|This was an open-label, 2-part (Part A & B), single dose study in healthy participants to assess modified release (MR) prototype coated tablet formulations of GSK2982772 compared to an immediate release reference tablet formulation.|A total of 33 participants were enrolled in this study. In Part A, 16 participants were enrolled but 1 replacement participant was added (total=17). Participants from Part A did not continue to Part B. In Part B, 16 participants were enrolled.
713908|NCT03648983||
713909|NCT03648853|12 surgical patients were recruited between 10/3/19/2018 and 11/30/2018. All subjects completed the study. Study was conducted in surgical patients under general anesthesia at UCSF|
713910|NCT03647709|All patients to have total knee arthroplasty. All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C and blood pressure. All patients enrolled in educational program. All patients have pre-op physical therapy teaching.|
713911|NCT03647046||
713912|NCT03647033||
713913|NCT03646656||
713914|NCT03645811||
713915|NCT03645434|Subjects who met all the inclusion and none of the exclusion criteria were enrolled at 3 sites in Germany and 2 sites in the United Kingdom (UK).|Subjects attended Screening Visit within a 14 to 28-days Screening Period, before receiving their first dose of AZD8871. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures.
713916|NCT03645421|Preobese/obese Japanese adults with Type 2 diabetes mellitus (T2DM) were recruited to this Phase IIa randomised, parallel-group, placebo-controlled, double-blind, study at 5 centres in Japan. The first patient started in August 2018 and the last patient completed in January 2019.|Patients with an early stage of T2DM who had inadequate blood glucose control, defined as glycated haemoglobin (HbA1c) between 7.0% and 10.5%, and who were treated with diet and exercise were enrolled. A body mass index of 24 to 40 kg/m2 was also a requirement. Patients with acutely decompensated blood glucose control were excluded.
713917|NCT03644212||
714300|NCT03508843||
714301|NCT03508687||
713923|NCT03643159||Virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled Abilify MyCite participants at the end of the study for analysis. Since the study was terminated early, no matching occurred.
713924|NCT03642873|This was a single-centre study.|A total of 24 subjects entered the study, among them 23 subjects completed the study.
713925|NCT03642457||
713926|NCT03642262|This was a single-centre study conducted in Canada.|Total Thirty (30) subjects were enrolled in the study among them 27 subjects completed the study.
713927|NCT03641508||
713928|NCT03640832|All the participants were enrolled from one center in Germany.|A total of 141 participants were screened for the study out of which 90 participants were enrolled and randomized to any of the 2 treatment arms. A total of 51 participants did not meet the study criteria and were not randomized. All 90 randomized participants completed the study.
713929|NCT03640559||
713930|NCT03640507|Participants will be recruited in-person only by study investigators/trained research personnel after admission to labor and delivery prior to administration of sedatives, anesthetics, or other mental-altering medications (note: some patients included in study will be in labor and may have already received regional anesthesia).|Participants need to be confirmed to be undergoing a Cesarean procedure.
713931|NCT03640052||
713932|NCT03639675|Study was conducted at 7 study sites in Japan from 3-Oct-2018 (first subject's first visit) to 14-Mar-2019 (last subject's last visit).|Overall, 17 participants were screened. Of these, 16 participants were assigned and received the study treatment.
713933|NCT03638908|Subjects were recruited solely from the clinic from November 2013 to November 2016|This was an open label study and all subjects were assigned to receive Fluoxetine.
713934|NCT03638635|Patients were approached for consent in the hospital postoperatively to request the use of their data for research purposes.|
713935|NCT03638323||"Number of screend patients: 46 Number of patient excluded: 9
~1 refusal
~7 lack an inclusion criteria or had an exclusion criteria
~1 was excluded after enrolment due to comprehension disorders and unreliable responses to the Hearing Questionnaire"
713936|NCT03637517|Clinical Pharmacology phase 1 unit.|30 day screening period.
713937|NCT03637348||
713938|NCT03636893||
713939|NCT03636386||
713940|NCT03635957|Data presented are as of the data cutoff date of 12 May 2020.|One participant was dosed with methotrexate (MTX) in the Run-In Period (MTX tolerance period) but was lost to follow up prior to the per protocol enrollment at Day 1. This participant was a screen failure but is included in the Run-in period data (including safety).
713941|NCT03635424||
713942|NCT03634579||
713943|NCT03634306||
713944|NCT03634085||
713945|NCT03633825|Participants were recruited from 39,450 Koko users who signed up for the service between August 10, 2017 and September 20, 2017. Koko (née Panoply) provides safety services for large online social networks.|All potential participants (N=39,450) screened for eligibility were considered enrolled. Potential participants were randomized upon accessing the platform, not later when identified as being in-crisis, because we used the platform's extant, AB-testing randomization tool. No other AB-tests were on the platform during the study period.
713946|NCT03633526|A total of 18 participants were enrolled in this study. Two participants were enrolled but were not dosed in triple combination (TC) treatment period. Therefore, results are reported for 16 participants.|This study was conducted in participants with cystic fibrosis (CF) 6-11 years of age. The study was terminated before start of Part B at Sponsor's discretion.
713947|NCT03633487|This was a single-centre study.|A total of 24 subjects entered the study; All 24 subjects were included single-period.
713948|NCT03633448|This was a single-centre study.|Total 24 subjects were enrolled in the study and all 24 completed the study.
713949|NCT03633344|In the study recruited 145 patients. One (1) of the patients dropped out of the study before being randomized.|
713950|NCT03632109||
713951|NCT03632083||This was a randomised, double-masked, contralateral, cross-over study in which subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in a lens care product Lite or Hy-Care.
713952|NCT03631732|Participants were enrolled at study centers in the United States. The first participant was screened on 28 August 2018. The last Week 48 study visit occurred on 04 Feb 2020.|"The following NRTIs & 3rd agents were allowed:
~NRTIs:abacavir, emtricitabine, lamivudine, tenofovir alafenamide, tenofovir disoproxil fumarate, zidovudine;
~3rd agents:delavirdine,efavirenz, nevirapine, rilpivirine,dolutegravir, elvitegravir,raltegravir, doravirine, atazanavir, darunavir, lopinavir, nelfinavir, saquinavir, tipranavir, maraviroc"
713953|NCT03630679||
713954|NCT03630185||
713955|NCT03630016||Eleven subjects were enrolled into the study with one subject later withdrawn due to poor sensor placement.
713956|NCT03629886|The study was conducted at 4 centers in China.|
713957|NCT03629184||
713958|NCT03629054|It was planned to include healthy participants in this randomised, open-label, two-way crossover trial with 2 treatments (test treatment (T) and reference treatment (R)) and 2 treatment sequences (TR or RT) in order to compare the treatment T to the treatment R under fed conditions. They were recruited from the volunteers' pool of the study site.|All participants were screened for eligibility to participate in the trial and to ensure that all participants met all inclusion/exclusion criteria. Participants were not to be included in the trial if any of the specific exclusion criteria were met.
713959|NCT03629041||Participants were healthy volunteers who have their regular dental care at Rhiwbina Dental Surgery.
713960|NCT03629028||
713961|NCT03628885||
713962|NCT03628599|Subjects were recruited from 4 investigational sites located in the United States.|Of the 39 enrolled, 2 subjects were discontinued (1 screen failure, 1 due to lens power not available) prior to randomization. This reporting group includes all randomized subjects (37).
713963|NCT03628456||
714015|NCT03608839|Data from DME diagnosed volunteers was collected and analyzed at the Department of Ophthalmology, State University of Campinas (UNICAMP), Brazil between May 2016 and December 2017|Informed written consent was obtained from all patients, and approved by the ethics committee of the Clinical Hospital of the State University of Campinas
714016|NCT03608488||
713964|NCT03628417|Participants with cutan metastases of melanoma malignum and breast cancer were followed-up at one of the academic medical center in Hungary between September 2016 and June 2019 based on oncologist refferal.|"Enrolled participants were not excluded from the study before assignment to groups. Block randomization was performed separately on each metastasis, so the patients received both treatments.
~The bleomycin and calcium syringes were mixed and labeled with numbers according to the metastases."
713965|NCT03627832||
713966|NCT03627494|This was a 3 part study conducted at a single center in the United States where, Part A is a single oral dose, dose-rising, 3 period crossover study; Part B is a repeat oral dosing, dose escalation study and Part C is a crossover study where a single dose was administered in fasted or fed conditions.|A total of 66 participants were enrolled in Part A (18 participants), Part B (36 participants) and Part C (12 participants).
713967|NCT03627299||Of 11 participants who signed consent, 10 received organ offers from HCV+ deceased donors. The remaining participant did not receive an offer before enrollment in the study closed.
713968|NCT03627195||
713969|NCT03626714||
713970|NCT03626415||
713971|NCT03624946||
713972|NCT03624920|105 patients were screened and 77 were randomized and allowed to start the medications periods.|
713973|NCT03624504||
713974|NCT03623698||
713975|NCT03623035||
713976|NCT03622112|The study was conducted in 92 sites in 8 countries; Bulgaria, Germany, Hungary, Poland, and Ukraine, United States (US), South Africa, and Japan. In this study, 806 patients (including 82 Japanese patients) were randomised. For sites in the US, no patients were randomised to the AZD7594 792 μg/720 μg once daily (QD) treatment arm.|Subjects attended a Screening Visit within 28 days before receiving their first dose. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures. One patient in the AZD7594 50 μg treatment arm did not receive any treatment and was randomised in error (protocol deviation).
713977|NCT03621878||
713978|NCT03621787||
713979|NCT03621202||
713980|NCT03620708||
713981|NCT03620383||
713982|NCT03619889||
713983|NCT03619590|Study population included pregnant women who prospectively reported exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. 245 pregnancies were prospectively registered in the study. 142 pregnancies were lost to follow-up. Outcomes were reported for 103 pregnancies. Hence, the number of subjects started is 103.|A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester, respectively.
713984|NCT03619135||
713985|NCT03618628||
713986|NCT03618147||
713987|NCT03618017||160 eligible women were invited to participate; 66 women enrolled (completed the baseline survey and were randomized).
713988|NCT03617861||
713989|NCT03617588|Recruitment Period June 18th 2018 to June 12th 2019.|
713990|NCT03617523|Participants were enrolled from 10 September 2018 to 22 October 2018 at 3 centers in the United States.|A total of 240 participants were enrolled in the study.
713991|NCT03617419||
713992|NCT03616977||
713993|NCT03616600||
713994|NCT03616171|Participants were enrolled between August 30, 2017 and April 2, 2018 from Georgia State University in Atlanta, Georgia.|A total of 19 individuals consented to take part in the study, of which 13 did not meet eligibility criteria during the screening process, resulting in 6 participants who were randomized to a study arm.
713995|NCT03616106|"Recruitment of interventionists
~Initially, 2 interventionists were enrolled, then one left the study and a replacement interventionist was recruited.
~Patient participant recruitment
~Initially, 50 participants were enrolled. Data was deleted for 6 participants due to a technical error. They were replaced with 6 additional patients."|
713996|NCT03615911||
713997|NCT03615807||
713998|NCT03615534|Obese females (BMI≥30 kg/m2), within the age of 20-60 years, attending the Obesity research and therapy unit of Al-Kindy College of Medicine, Baghdad, Iraq, throughout the period from 1st October 2014 to 15th March 2015, were screened for preliminary eligibility.|Out of the 161 obese females settled for participation, Atherogenic dyslipidemia (AD) was diagnosed in 69(42.9%) patients, all of whom were enrolled in Therapeutic Lifestyle Changes (TLC) run-in period. AD was averted by TLC in 12(17.4%) patients. The remaining 57(82.6%) non-responding patients were randomly allocated to one of the four study arms.
713999|NCT03615508||
714000|NCT03615482||
714001|NCT03615183|Anti-retroviral therapy (ART)-naïve, participants with human immunodeficiency type 1 virus (HIV-1) infection were enrolled in this study.|
714002|NCT03615001||
714003|NCT03614975||
714004|NCT03614156|Patients from RAP-MD-33 completed one of the rapastinel lead-in studies - RAP-MD-30, RAP-MD-31, or RAP-MD-32.|363 patients enrolled in the Open Label Treatment Period (OLTP). Of these, 209 completed OLTP and 137 entered Double Blind Treatment Period (DBTP) and were randomized. Patients who completed or discontinued from the study can enter a 2-wk safety follow-up period (SFUP). 165 patients from OLTP and 91 patients from DBTP entered the SFUP.
714005|NCT03614078||
714006|NCT03613649|The trial was performed at a commercial phase 1 unit. Recruitment opened on September 4, 2018 and all 72 participants were consented and screened for meeting eligibility criteria prior to enrollment and dosing. Enrollment was completed on December 04, 2018.|
714007|NCT03613493||
714008|NCT03613129||
714009|NCT03612856||A total of 37 participants were screened for the study, of which 10 did not meet eligibility criteria. The remaining 27 participants were enrolled. 3 participants terminated the study prior to randomization either by withdrawing consent or at the PI's discretion. The remaining 24 participants were randomized into the study and dosed.
714010|NCT03611829||
714011|NCT03610633||
714012|NCT03610464||
714013|NCT03610269||
714014|NCT03609619||
714065|NCT03585296||
714066|NCT03583450||
714067|NCT03583385||
718938|NCT02696070||
714017|NCT03607682|This trial was open to accrual from September 2018 to June 2020 at Vanderbilt Medical Center in Nashville, TN. Two participants were enrolled. The study stopped early due to loss of funding.|2 participants were enrolled; 1 participant had disease progression and was not on the study long enough to be evaluable.
714018|NCT03607487|The study was conducted at 9 different sites in Canada, 2 different sites in Germany and 1 site in Denmark|A total of 43 participants were screened for enrollment in the study, 8 did not meet the eligibility criteria. A total of 35 participants were randomized to one of the treatment groups.
714019|NCT03606460||
714020|NCT03606343|Youth with ASD without ID attending middle school and their parents were recruited in the 2018-2019 academic school year via letters, flyers, and emails targeted at individuals who had received services at a hospital outpatient clinic specializing in assessment and treatment of autism.|
714021|NCT03605693||
714022|NCT03605303|On July 06, 2018 Johnson & Johnson Vision terminated this study prematurely after lens testing revealed that the lens thickness in the mid-periphery of the lens were thinner than the lens design targets. As of this date only 3 subjects were enrolled at 1 site.|
714023|NCT03604497||437 individuals enrolled and 385 crossed the street at least once during the protocol, suggesting they participated. The numbers do not add up since it is a crossover trial.
714024|NCT03604341||2 participants failed to meet the inclusion criteria after enrollment and were not assigned to a treatment group.
714025|NCT03604263||
714026|NCT03603652||
714027|NCT03603106||For part I, all patients who were not randomized were screening failures. For part II, all patients who were not allocated to a dose of P03277 were screening failures.
714028|NCT03603028||One individual was unable to participate in Days 2, 3, and followup of the protocol.
714029|NCT03602053||
714030|NCT03601715|Paticipants, reached through social media, volunteered to participate in the study.Participant enrollment began on 9/3/18 and the last participant was enrolled on 11/9/18.|All the twenty health enrolled male subjects met the inclusion criteria and were randomly allocated an order in which treatments were received.
714031|NCT03599986||
714032|NCT03599687||
714033|NCT03599349||
714034|NCT03599193||
714035|NCT03598140||
714036|NCT03597178|A total of 16 subjects were enrolled into this study. Of those enrolled, 2 failed to meet all eligibility criteria. Of 14 dispensed subjects all completed the study.|
714037|NCT03597022|Study was conducted at multiple centers in 11 countries or regions between 24 July 2018 (first subject first visit) and 15 October 2019 (last subject last visit).|Overall, 26 participants were screened. Of them, 1 participant was screen failure and 1 participant could not start subsequent treatment on schedule; 24 participants received study treatment.
714038|NCT03596723||
714039|NCT03595215||
714040|NCT03594227||
714041|NCT03594045||
714042|NCT03593902||
714043|NCT03593200|This Phase 2a, open-label, multiple-dose study was conducted in subjects with paroxysmal nocturnal hemoglobinuria (PNH) who had not received treatment with eculizumab (Soliris®) in the past, between 16 August 2018 and 22 October 2019.|Up to 20 subjects were planned to be enrolled; however, the sponsor decided to close recruitment after 4 subjects were enrolled based on the conclusion that sufficient data were collected to meet the study objectives.
714044|NCT03592186|"74 participants (37 dyads) were recruited from a short-term residential facility and 48 participants (24 dyads) were recruited from a long-term facility.
~The long-term facility was added in Year 3 of the trial to improve recruitment and inform design of a fully powered trial (consistent with recruitment plan outlined in the grant proposal)."|Following informed consent, participants had to complete a baseline assessment and confirm discharge to parental custody (study inclusion criteria) before randomization. 10 participants (5 dyads) that consented were not randomized and not included in the final intent-to-treat sample because of these inclusion criteria.
714045|NCT03592121||
714046|NCT03591458||
714047|NCT03591406||Subjects who provided signed and dated informed consent were screened within 7 days prior to initial treatment administration.
714048|NCT03591068||
714049|NCT03590743||
714050|NCT03590613|This was a 4-way crossover, single-center, randomized, double-blind, dose-ascending, placebo (PBO)-controlled study to evaluate the safety, tolerability, and pharmacokinetics of oral TID doses (thrice a day) of GSK2982772 in healthy male Japanese participants|A total of 13 healthy male Japanese participants were enrolled in the study to receive GSK2982772 and PBO from a single center in Japan
714051|NCT03588806||
714052|NCT03588741|The trial was conducted at 1 trial site in Germany.|Previously treated participants with severe haemophilia A (FVIII activity <1% according to medical records) who had developed clinically relevant FVIII inhibitors in trial NN7170-4213 were offered immune tolerance induction (ITI) treatment with turoctocog alfa.
714053|NCT03588572||
714054|NCT03587974||
714055|NCT03587428|All the participants were recruited from one center in United Kingdom.|A total of 16 participants were screened, out of which 1 did not met the study criteria. Total of 15 participants were randomized to study treatments.
714056|NCT03587207|Subjects were recruited from 1 center at Czechia.|Out of the total 520 subjects enrolled in this study, 500 subjects received the vaccination. Among the 20 subjects that were not vaccinated, 15 did not fuflill eligibility criteria and 5 were excluded due to other reasons.
714057|NCT03586830||Total 196 participants were randomized out of which 175 participants completed study.
714058|NCT03586726||
714059|NCT03586648|In total, 71 subjects were enrolled in this study of which, 70 subjects were dispensed at least 1 study lens, 1subject failed to meet all eligibility criteria. Of those dispensed a study lens, 61 subjects completed the study while, 9 were discontinued from the study.|
714060|NCT03586583||6 qualified radiologists were shown DBT (Tomosynthesis) of a breast with the modified processing side-by-side the same breast with the original processing. Each reader was given a unique sample of 100 cases to review. Images were acquired under Fujifilm image acquisition protocol FMSU2013-004A
714061|NCT03585959||
714062|NCT03585790||
714063|NCT03585543||
714064|NCT03585504||
714068|NCT03582943|Participants recruited by word-of-mouth and through participant registry. Assessed for eligibility, n = 182. Excluded, n = 100 with n = 33 not meeting criteria, n = 64 declined to participate, and n = 3 pilot participants who were not randomized.|
714069|NCT03582813|Eligible participants ( who were active Texas Department of State Health Services (DSHS) were recruited at community mental health agencies by local research staff between March 2009 and September 2010.|
714070|NCT03582553|38 subjects were screened for eligibility between May 25, 2018 and September 12, 2018.|Of the 38 participants screened, 10 participants did not meet the study criteria, 7 had schedule conflicts and declined to participate, and 3 were screened before the study was determined to have met the recruiting goal. 18 participants were randomized.
714071|NCT03582215||Equal allocation of men and women for each treatment arm.
714072|NCT03581825|A total of 63 subjects were enrolled in this study. Of those, 62 were dispensed at least 1 study lens. Of those dispensed a study lens, 60 subjects completed the study while 2 were discontinued from the study.|
714073|NCT03581474||
714074|NCT03581097|A consecutive cohort of adult patients scheduled for elective ambulatory hand surgery of less than one-hour duration with an intravenous regional anesthesia was recruited|Patients were randomized with a free web tool (available at www.randomizer.org) in a consecutive order into two parallels groups
714075|NCT03580382||
714076|NCT03579940||Crossover study with three study periods, each participant received single/repeated oral doses of 50, 100, 200, 400, or 2 X 200 milligram (mg) lasmiditan, placebo, or 2 X placebo, according to their assigned treatment sequence, on Day 1 of each Period. The washout period between dosing in consecutive study periods was approximately 72 hours.
714077|NCT03579719|The study was conducted at 1 site in the Netherlands.|Participants in this study included healthy volunteers.
714078|NCT03579433|Of the 124 subjects enrolled, 12 subjects were discontinued prior to randomization, and 8 subjects were randomized, but not treated in either eye. This reporting group includes all subjects with attempted implantation of an intraocular lens (IOL) in one or both eyes.|
714079|NCT03578926|45 habitual lens wearers were enrolled. 1 participant was ineligible for the study due to an unacceptable lens fit. 44 participants were dispensed and completed all study visits.|
714080|NCT03578549||
714081|NCT03578146|Subject recruitment occurred at investigative site in the US between March 2013 through April 2014|Rivaroxaban was administered orally at 20 mg once daily for 6 days to steady-state in an open label fashion. Subjects were then randomized to receive study treatment (andexanet or placebo) intravenously at different doses/dose regimens on Day 6, all bolus doses administered such that they ended at 3 hours after the last dose of rivaroxaban.
714082|NCT03577275||This was a cross over study so 32 subjects each completed 4 treatment arms
714083|NCT03576118||
714084|NCT03575962|This was a single center, open-label, randomized, two-period crossover study to assess the relative bioavailability of a mesylate salt capsule of GSK3640254 compared to a hydrochloride salt capsule in healthy participants.|Participants received treatment in one of the two sequences; regimen A (GSK3640254 hydrochloride salt capsule) followed by regimen B (GSK3640254 mesylate salt capsule) or vice versa in each of the treatment period 1 and 2. A total of 14 participants were enrolled in the study.
714085|NCT03575871|Participants with age greater than or equal to (>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of >=40 kilograms were enrolled in the study. Eligible participants had an option to enter into a long-term extension (LTE) study after completing 12 weeks of treatment in this study.|This study was conducted from 29-June-2018 to 13-Aug-2019 at 106 sites in 13 countries.
714086|NCT03575806||This study was not of a randomized design, patients were recruited by their willingness to receive the Tcm transfusion as the adjuvant therapy after screening and meeting the eligibility criteria. As pathological classification with MVI was determined after 1 week postoperatively, patients consented with radical operation would be screened again.
714087|NCT03575702|Subjects enrollment was conducted in 11 clinical sites in Russia between July 2016 and April 2017. After the screening period 300 patients (150 in each group) were included in the study. 299 patients started study treatments.|
714088|NCT03574818|one patient was enrolled in May 2018, study was terminated in September 2019 due to poor accrual|
714089|NCT03574441||
714090|NCT03573908||"Treatment Period (TP, 12 weeks): Participants were randomized 1:1 to linaclotide 290 μg or placebo once daily.
~Randomized Withdrawal Period (4 weeks):
~Participants randomized to linaclotide 290 μg during TP were rerandomized 1:1 to linaclotide 290 μg or placebo
~Participants randomized to placebo during TP were allocated to linaclotide 290 μg."
714091|NCT03573830|Participants were recruited online, between the 10th and the 27th of December 2018, through a market research service, Maru Blue, which keeps a database of 130,000 individuals who have consented to receive invitations to online surveys. Individuals registered in the database were sent an email invitation, which included a link to our online survey.|Our target sample size was 606, as stated in the protocol. However, we were able to enroll more than our target: 731
714092|NCT03573817||Participants were randomized 1:1 to one of two treatment groups and received treatment twice-daily for the two 21-day treatment periods. The participants in Arms 1 and 2 are the same (minus attrition), and the participants in Arms 3 and 4 are the same (minus attrition).
714093|NCT03573505|Participants were enrolled at 47 investigational sites in 16 countries from September 24, 2018 to November 14, 2019.|A total of 109 participants with Idiopathic pulmonary fibrosis (IPF) were enrolled and randomized in this study. Of which, 106 participants received at least one dose of study drug. The maximum length of the dosing period was up to Week 46. Participants were then followed-up for safety for up to Week 60.
714094|NCT03573323||The study consists of a combined blinded treatment (trt) period with a 24-week duration followed by a post treatment follow-up (PTFU) period with a minimum of a 12-week duration. The Induction Dosing Period (12 Weeks) and Extension Period (12 Weeks) were combined for analysis and referred to as the blinded treatment periods.
714095|NCT03573206||
714173|NCT03550378|The study was conducted in the United Kingdom and Germany between 29Jun2018 and 04Feb2019.|A total of 41 participants were randomized to the study.
714174|NCT03550066||
714175|NCT03549598||
714345|NCT03495856|Recruitment Dates: April 2018 to September 2018 Recruitment Setting: Medical clinics; University/Medical center campus and email listserve|
714096|NCT03572972|Data was retrieved from Korean Health Insurance Review & Assessment Service (HIRA) database, of participants who were diagnosed with non-valvular atrial fibrillation (NVAF) from 1-January-2007 up to and including index date, who newly initiated non-vitamin K antagonist oral anticoagulants (NOACs), warfarin or used aspirin during intake duration.|It is a retrospective, observational study. Index date: first prescription date of study drugs during intake duration. Intake period: between 1-July-2015 to 30-November-2016. Inverse probability of treatment weighted (IPTW) method was used to analyze outcome measures to balance participant's characteristics among reporting arms.
714097|NCT03572218|Recruitment began April 2018 and ended October 2018. Participants were recruited by flyers, local media, and physician referrals for a study about weight loss and social experiences related to weight. Participants were screened by telephone and by a subsequent in-person behavioral evaluation and brief medical evaluation.|
714098|NCT03571724|A total of 142 smokers were recruited from two sites in the United States; Celerion, Lincoln Nebraska and High Point Clinical Trials Center, High Point, North Carolina. The participants were recruited via social media, print, TV, radio, referrals.|Subjects may have been excluded from the study if there was evidence of any of the exclusion criteria during the study as noted, in the opinion of the Investigator.
714099|NCT03571672||
714100|NCT03571607||
714101|NCT03571256||A total of 158 participants were randomized in a 1:1:1 ratio to TEV-50717 high-dose, TEV-50717 low-dose or placebo group.
714102|NCT03570658|Healthy male Chinese subjects aged 18-60 years.|"Total n=31.
~SAD n=28 (Active treatment n=22 and placebo n=6). 21 participants continued on to the MAD phase of the study. 3 participants chose not to continue.
~MAD n=24. 3 participants were directly enrolled into the MAD phase of the study in addition to the 21 participants from the SAD phase."
714103|NCT03570554|Study was conducted at multiple centers in the US between 29 June 2018 (first participant first visit) and 14 June 2019 (last participant last visit).|Overall, 209 participants were screened. Of them, 168 participants were screen failures, and 41 subjects were randomized to study treatments.
714104|NCT03570476||
714105|NCT03570255||
714106|NCT03570047|It is a retrospective population-based register study. Data of each participant diagnosed with non-valvular atrial fibrillation (NAVF) was retrieved from Medical Data Vision (MDV) database for the duration of approximately 7 years (March 2011 to December 2017).|In this study, inverse probability of treatment weighted (IPTW) method was used in analysis of outcome measures to balance participant's characteristics among reporting groups.
714107|NCT03569618||
714108|NCT03569371|The study was conducted at 4 different sites in US.|A total of 10 participants were assigned to treatment with INCB054707.
714109|NCT03569202|The study comprised three sequential parts. Parts 1 to 3 involved different participants each, thus no participant flow between parts (or periods) took place.|
714110|NCT03569033||
714111|NCT03568942|This was an open-label study to evaluate the pharmacokinetic (PK) of repeat oral doses of gepotidacin in adult female participants with clinical signs and symptoms of acute cystitis.|A total of 22 participants were enrolled in this study. This study was conducted at a single center in the United States.
714112|NCT03568500|The trial enrolled participants with a confirmed clinical diagnosis of schizophrenia, schizoaffective disorder, or first episode psychosis.|Participants in this trial received at least 1 CoEncapsulated miniature ingestible event marker in a tablet and a medicinal product originator tablet of either aripiprazole, olanzapine, or quetiapine (participants were allowed to take risperidone, though no participant took risperidone in this trial) as prescribed by their healthcare professional.
714113|NCT03567005|Subjects were recruited from 5 investigative sites located in the United States.|All 60 enrolled subjects were randomized and exposed to the investigational products.
714114|NCT03566979||
714115|NCT03566810||
714116|NCT03566680|Subjects were recruited if they were in the 18-45 had significant Contact lens dry eye questionnaire 8 (cldeq-8) scores (12 or greater), subjects also had to be previous spectacle or contact lens wearers, and had relatively healthy meidcal history, as well as being able to be fit within the approved fda range for orthok (orthokeratology) lenses.|
714117|NCT03565887|Planned sample size was approximately 156 subjects, 104 subjects in the RVL-1201 group, and 52 in the Vehicle group, to be enrolled at approximately 30 clinical sites in the U.S.|
714118|NCT03565874||
714119|NCT03565679||
714120|NCT03565666|18 participants were recruited at MGH and 18 participants at Stanford|This study consisted of a test-run period followed by an RCT
714121|NCT03565328||2 participants signed informed consent: 1 subject completed the study; 1 subject failed the screening. Study was terminated due to lack of enrollment and precluded analysis of primary or secondary outcomes.
714122|NCT03565315||
714123|NCT03565211|The trial was conducted at 14 trial centers in the United States (US) between 26 July 2018 to 29 July 2019.|In total 352 participants were screened. Of these, 98 were screening failures and 254 participants were treated with investigational medicinal product (IMP), progesterone vaginal ring (PVR).
714124|NCT03564886||
714125|NCT03564444|The study was conducted between 06Jun2018 and 27Dec2018 in the USA.|
714126|NCT03564353||
714127|NCT03563716|Participants were recruited at study sites in 6 countries.|Eligible patients with previously untreated, locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC) were randomized 1:1 to receive either placebo plus atezolizumab or MTIG7192A plus atezolizumab.
714128|NCT03563313||
714129|NCT03563209|This study enrolled patients with post-stroke elbow flexor spasticity from a single medical center in Turkey. The last patients completed in July 2018|
714130|NCT03563183||Of the 29305 subjects in the Total Vaccinated cohort (TVC) of study ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229), 2329 subjects were excluded as they belonged to centers not participating in the current study Zoster-064(Z-064). Thus, 26976 subjects were eligible for Inclusion in the Z-064 TVC.
714131|NCT03562559|Patients older than 18 years of age undergoing elective total knee arthroplasty who were able to give informed consent|
714132|NCT03562481||
714176|NCT03549429||"A total of 159 patients were enrolled (consented) but not randomized. The reasons for not randomizing include:
~Research assistant unavailable (n=6)
~Anesthetic plan change (n=4)
~Surgical plan change (n=4)
~Tape sensitivity (n=1)"
714133|NCT03562117|This was a Phase I, non-randomized, open-label, parallel-group, multi-center, two-part study that evaluated the pharmacokinetics, safety, and tolerability of a single 1500 milligrams (mg) oral dose of gepotidacin in participants with normal hepatic function and in participants with mild, moderate, and severe hepatic impairment.|Twenty five participants were enrolled in the study. In part 1, normal hepatic function participants were matched to moderate hepatic impaired participants. In Part 2, participants with severe hepatic impairment were matched to normal hepatic function participants who participated in Part1.
714134|NCT03560986|First participant enrollment on 31 May 2018. After a pooled interim analysis of primary endpoint data of studies KF7013-04 and KF7013-02 (NCT03530345), recruitment was stopped as interim results indicated futility. Last participant's last assessment was on 01 Aug 2019.|267 participants were enrolled (signed consent), 100 were allocated to treatment, and 99 received study medication. Of 167 participants not allocated, 99 did not meet inclusion/met exclusion criteria, 3 were lost to follow-up, 14 withdrew consent, 1 experienced adverse events, and 50 were not allocated for other reasons (study termination).
714135|NCT03560739||344 participants were screened
714136|NCT03560518||
714137|NCT03560245|111 subjects were randomized, but 3 subjects withdrew prior to receiving treatment. 108 subjects received treatment.|
714138|NCT03560128||
714139|NCT03559829||
714140|NCT03559257||
714141|NCT03559179||
714142|NCT03559062||A total of 69 participants were randomized, out of which 67 participants received study drug and were included in participant flow and baseline characteristics section.
714143|NCT03558997|A total of 214 participants were screened for study eligibility at 17 study sites in United States and Canada, of whom 103 were randomized to receive the study treatment. Screen failure was mostly due to inclusion criteria not met/exclusion criteria met.|Participants who met the eligibility criteria were randomized in 1:1:1:1 ratio to 1 of 4 treatment groups: Placebo, Dupilumab, Subcutaneous immunotherapy (SCIT) and Dupilumab + SCIT.
714144|NCT03558672|Participants were recruited among therapists and physicians across 4 US sites between September 2018 and March 2020. The first subject was enrolled on September 14, 2018.|
714145|NCT03558555|Participants presenting for laparoscopic hernia repair under general anesthesia in an ambulatory setting were recruited from July 2017 to December 2018. First enrollment in Dec 2017.|
714146|NCT03558516||
714147|NCT03558230||
714148|NCT03558074||
714149|NCT03558061||
714150|NCT03557931||Participants who were 18 to 55 years of age (inclusive at screening) with stable schizophrenia or schizoaffective disorder with mild extrapyramidal symptoms on up to 2 antipsychotic therapies and who met inclusion criteria and none of the exclusion criteria were enrolled.
714151|NCT03557801||
714152|NCT03557775||We had 22 subjects enrolled, however one did not meet the screening requirements and was not further included in the study (and therefore was not randomized to an intervention group). Another participant withdrew before being randomized to an intervention group. In total, 20 participants were randomized to the intervention groups.
714153|NCT03557476||
714154|NCT03556761||
714155|NCT03556579|A total of 62 subjects were into this study. Of those enrolled, 60 were assigned and administered a study lens. Two subjects were enrolled but not administered a study lens. All 60 subjects completed the study.|Subjects were stratified into two age groups: 18-39 and 40-65 using a 2:1 allocation. Subjects were randomized at each visit using a contralateral design.
714156|NCT03555890|This was a single center, single dose, open-label, randomized, 2-part, 2-way crossover study. Bioequivalence (BE) between levocetirizine (levo) oral disintegrating tablet (ODT) and levocetirizine immediate release tablet (IRT) was evaluated in 72 healthy Japanese participants.|A total of 133 participants were screened, of them, 72 participants were randomized to receive study treatment. All participants except one participant randomized in Part 2 (Initial study) completed the study.
714157|NCT03555565|Participants took part in the survey at 115 investigative sites in Japan, from 28 February 2017 to 31 October 2019.|Participants with a historical diagnosis of type 2 diabetes mellitus with renal or hepatic impairment or advanced age were enrolled. Participants received alogliptin and metformin hydrochloride combination tablets as part of a routine medical care.
714158|NCT03555435||
714159|NCT03555305||Two period crossover study, with a minimum of 7 days washout period between each period.
714160|NCT03554954||
714161|NCT03554746||
714162|NCT03554629|"Execution of CIP v 1 enrollment at 6; data not included in results since data inadequate.
~Execution of CIP V2 enrollment was 23 One subject withdrawn before participation due to failure to meet failure to meet criteria of enrollment on the study day (runny nose)"|
714163|NCT03554005||
714164|NCT03553758||
714165|NCT03552549||
714166|NCT03552536|Participants with human immunodeficiency virus-1 (HIV-1) infection who were naïve to anti-retroviral therapy (ART) were enrolled. Only participants from Panel A were recruited. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.|
714167|NCT03552523||16 subjects consented and were screened for eligibility. 7 subjects were ineligible. Of the 9 that were eligible, 2 subjects were eligible but not able to schedule their study participation. The other 7 eligible subjects were randomized and started participating in the trial. 5 of those 7 subjects completed both arms of the study.
714168|NCT03552289||
714169|NCT03551821||
714170|NCT03551743|Subject recruitment occurred at investigative site in the US between March 2014 through August 2015|28 subjects were enrolled in Module 4. Edoxaban was administered 60 mg orally once daily for 6 days in an open label fashion. Andexanet/placebo was administered intravenously (IV) on Day 6 such that they ended at 3 hours (Cohorts 1 and 2) or 5 hours (Cohort 3) after the last dose of edoxaban.
714171|NCT03551730|Subject recruitment occurred at investigative site in the US between August 2013 through November 2013|Enoxaparin was administered subcutaneously at 40 mg once daily for 6 days to steady-state in an open label fashion. Subjects were then randomized to receive study treatment intravenously on Day 6; such that they ended at 3 hours after the last dose of enoxaparin.
714172|NCT03550989||
714346|NCT03495817||
714347|NCT03495102||
714177|NCT03549338|The intended number of patients to be included in this trial was approximately 54 (18 evaluable per Arm). As of the trial termination date, 2 patients were enrolled.|The first patient was randomized to Arm B prior to the trial termination date and crossed over to Sym004 at the EOC1. The second patient was randomized to Arm B after the trial termination date, but enrolled to Arm A per Sponsor decision.
714178|NCT03549234||
714179|NCT03549130|All participants were recruited at two centers in USA.|A total of 235 participates were screened, out of which 130 participants were enrolled and randomized in the study. 105 participants were not randomized as 104 of which did not meet study criteria, 1 had adverse event.
714180|NCT03549117|All participants were recruited from two centers in USA|A total of 200 participants were screened. Out of which 140 participant were randomized in the study. 60 participants were not randomized as 52 of which did not meet study criteria, 2 had adverse event, 3 were lost to follow up, 2 withdrew consent and 1 because of other (unspecified) reason.
714181|NCT03548337||
714182|NCT03547635||
714183|NCT03547583|Study was conducted at 178 study centers worldwide, between 15-Jun-2018 (first subject first visit) and 04-Nov-2019 (last subject last visit).|Overall, 979 participants were screened, of whom 789 participants were randomized in the study. 788 of the randomized participants were allocated to study treatment, of whom 672 participants completed the study.
714184|NCT03547531|All of the participants were fifth graders from 2 elementary schools in Yogyakarta, Indonesia. These two schools have the similar characteristics in social-economy, number of students, and the type of school based on the data and recommendation from Education and Culture Office of Sleman District, Yogyakarta, Indonesia.|Each school had 62 fifth graders (total participants of both school was 124 fifth graders). No participants were excluded. Random group assignment was done by coin flipping to choose one school as control group and the other as intervention group.
714185|NCT03547154||
714186|NCT03546842||
714187|NCT03546816|The study was conducted at 49 sites in United States from 02 May 2018 to 14 February 2020. All subjects who met the study entry criteria were randomized in a 1:1 ratio to receive once-daily oral doses of serlopitant 5 mg or placebo for 10 weeks.|During the screening period (2-4 weeks), all subjects were evaluated for eligibility and assessed for conditions associated with chronic pruritus. Subjects were to complete an electronic diary (eDiary) during screening visit.
714188|NCT03546621|Of 120 randomized patients 118 started treatment with study medication (2 patients from Tenofovir only group withdrew before treatment)|
714189|NCT03546491||
714190|NCT03546270||
714191|NCT03546192|Study participants were enrolled in 3 centers in the Philippines from 17 June 2015 to 26 June 2015.|A total of 120 participants (60 for each group) were enrolled and vaccinated in the study.
714192|NCT03545984|Several residents who were randomized were unable to complete the study because they did not participate in the management of patients undergoing open or endovascular aortic surgery that required CSF drainage catheter insertion during their rotation..|This educational randomized trial was conducted on residents and they were enrolled and randomized in two study groups (arms) corresponding to two educational methods. Patients were not considered enrolled in this study.
714193|NCT03545893||
714194|NCT03545412|The study was conducted at 1 site in Taiwan.|A total of 25 participants were screened, enrolled and treated in the study.
714195|NCT03544879||
714196|NCT03544307||
714197|NCT03544242||
714198|NCT03544216||
714199|NCT03543176|This cross-sectional observational survey study aimed to assess symptom burden and Baseline clinical and economic characteristics in chronic obstructive pulmonary disease (COPD) participants treated with single-inhaler dual therapies in adult Medicare Advantage (MA) enrollees with COPD diagnosis and treatment.|A total of 789 claims linked analytic participants were enrolled in the study.
714200|NCT03543137|The study was conducted at single center in United States. A total of 61 participants were screened, of whom 37 were randomized for treatment and 24 were screen failures.|Participants received treatment in one of the two sequences; treatment A (Prototype Mini Lozenge: Reference drug) followed by treatment B (Nicorette Mini lozenge: Investigational drug) or vice versa in each of the study period 1 and 2.
714201|NCT03542474||
714202|NCT03541356|Parkinson's disease patients at movement disorder clinics in Australia|Confirmation of L-dopa responsiveness at Visit 2, prior to randomization
714203|NCT03541044|The study was conducted at single center in United States. A total of 90 participants were screened, of whom 46 were randomized for treatment and 44 were screen failures.|Participants received treatment in one of the two sequences; treatment A (Prototype Mini Lozenge: Reference drug) followed by treatment B (Nicorette Mini lozenge: Investigational drug) or vice versa in each of the study period 1 and 2.
714204|NCT03540160|The study was conducted at 120 sites from 15 March 2018 to 08 April 2020. All participants who met the study entry criteria received daily oral doses of serlopitant 5 mg tablet.|Subjects attended a screening visit before receiving their first dose. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study-related procedures.
714205|NCT03540030|Patients were identified in clinic by the surgeon performing the shoulder arthroplasty. The surgeon introduced the concept of opioid-free arthroplasty with the patients, who then chose whether to follow the traditional or opioid-free pathway. The surgeon then notified the study coordinator of the patient's decision and patients were consented.|
714206|NCT03539549||A total of 124 participants were enrolled in the study. Out of 124, one participant was not treated with study drug and was subsequently discontinued from the study. The participant was not included in the Safety Population or analyses.
714207|NCT03539484||
714208|NCT03539211||
714209|NCT03538808||None, all participants that were enrolled in the study were randomized into one of the four conditions.
714210|NCT03538795|Participants will be recruited from a list of stroke survivors who have contacted our lab but have been excluded from past studies because their motor impairment was too severe. The recruitment period was June 11, 2018 to February 14, 2019.|
714211|NCT03538743||
714297|NCT03509675|The recruitment started in April 2018 and ended on Jan 30, 2019. All subjects were asked to join the trial at Oral Medicine Clinical Services at the University of Washington.|
714549|NCT03438578||
714212|NCT03538717|Data was collected and observed retrospectively for approximately 1 year, of metastatic renal cell carcinoma (mRCC) participants who received axitinib in the daily clinical practice as second and later lines prior to inclusion in study and met inclusion/exclusion criteria.|
714213|NCT03538015||
714214|NCT03537664||Samples from 20 patients were used for the analysis of total bacteria in 1st and 2nd visits. Additional 25 patients were necessary for the analysis of specific bacterial species in post-instrumentation samples (n=45 patients).
714215|NCT03537404|Healthy adult volunteers were recruited for all Parts of the study in one clinical site (Bessalar clinic) in Moscow between April and June 2017. 36 subjects were randomized so that 18 subjects participated in each Part of the study (6 subjects in each treatment group of each Part).|Subjects were to be screened within 28 days before dosing in this multi-part study. Subjects were to be admitted to the study center the evening before the first dose for baseline assessments to confirm eligibility.
714216|NCT03537274|In total, 1224 participants with chronic Hepatitis C virus (HCV) infection were randomized, with 1219 receiving study treatment.|
714217|NCT03537092|From 05/22/2018 to 11/01/2018, 84 women were recruited and screened from gynecology clinics at Magee-Womens Hospital at the University of Pittsburgh Medical Center and the surrounding community. The study was fully enrolled with 64 participants on 11/13/2018.|
714218|NCT03536949|Planned sample size approximately 225 subjects, 150 subjects in the RVL-1201 group and 75 subjects in the Vehicle group, to be enrolled at approximately 30 clinical sites in the U.S.|
714219|NCT03536923||
714220|NCT03536819||
714221|NCT03536702||60 subjects signed consent. Results reported are for completers only. Completers are participants who signed consent, were randomized, completed baseline measures and took at least one class after baseline.
714222|NCT03536663|Hemodialysis patients were recruited at three clinical sites in the USA. 23 subjects were enrolled to this study. The first subject first visit was on August 29, 2018 and the last subject last visit was on April 17, 2019.|
714223|NCT03535974||
714224|NCT03535844||
714225|NCT03535649|Participants took part in the study at 13 investigative sites in South Korea from 17 August 2017 to 18 December 2018.|Participants with a diagnosis of moderately to severely active ulcerative colitis (UC), having failed tumor necrosis factor-alpha (TNF-alpha) antagonist therapy and who have been prescribed vedolizumab intravenously under standard clinical practice were enrolled in this observational study.
714226|NCT03535571||
714227|NCT03534986||
714228|NCT03534427||
714229|NCT03534362|Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.|
714230|NCT03533829||
714231|NCT03533374||
714232|NCT03533244||
714233|NCT03533036|15 participants recruited to each group (experimental vs control)|Patients were assigned to either experimental or control group via convenient sampling.
714234|NCT03532048|Goal of 40 families (160 individuals) to be recruited.|
714235|NCT03531905||
714236|NCT03531710||
714237|NCT03530917|The study was conducted at 1 Center in China.|A total of 70 Healthy Male and Female Chinese Participants were enrolled.
714238|NCT03530631||Only four subjects were recruited for this pilot study
714239|NCT03530345|First participant enrollment on 30 May 2018. After a pooled interim analysis of primary endpoint data of studies KF7013-02 and KF7013-04 (NCT03560986), recruitment was stopped as interim results indicated futility. Last participant's last assessment was on 31 July 2019.|182 participants were enrolled (signed consent), 57 were allocated to treatment and received study medication. Of 125 participants not allocated, 95 did not meet inclusion/met exclusion criteria, 1 was lost to follow-up, 9 withdrew consent, 1 experienced technical problems, and 19 were not allocated for other reasons.
714240|NCT03530098||
714241|NCT03529942||
714242|NCT03529461|Recruitment began on 4/25/2017 and ended on 4/2/2018.|"208 patients assessed for eligibility:
~56 patients enrolled
~152 patients excluded (reasons: 127 not meeting inclusion criteria or no show for procedure, 6 patients declined to participate, 19 patients excluded because of early trial closure)"
714243|NCT03528369|Subjects were recruited at 6 investigative sites in the US.|Subjects were randomized to receive one of three treatments after the investigator deemed them to qualify for the study.
714244|NCT03528174||
714245|NCT03527966||
714246|NCT03527173|This study was conducted at one center in the United States of America (USA).|All 71 subjects enrolled in the study, received a study vaccination and were included in the All Exposed Set.
714247|NCT03526055||
714248|NCT03525678|This was a Phase II, open-label, randomized, multicenter study to evaluate the efficacy and safety of belantamab mafodotin monotherapy at a dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg, given intravenously (IV) in participants with relapsed/refractory multiple myeloma (RRMM).|A total of 293 participants were screened and 221 participants were enrolled and randomized in this study. The results presented are based on the interim analysis.
714249|NCT03525548|A total of 113 participants were enrolled in the study, of which 6 participants were included in the run-in period but were not dosed in TC treatment period. Results are presented for 107 participants dosed in the TC treatment period.|This study was conducted in participants with cystic fibrosis (CF) aged 12 years or older.
714250|NCT03525444|A total of 405 participants were enrolled in the study, of which 2 participants were enrolled but were not dosed in the triple combination (TC) treatment period. Results are presented for 403 participants dosed in the TC treatment period.|This study was conducted in participants with cystic fibrosis (CF) aged 12 years or older.
714251|NCT03525210|This is a single center, open-label, investigator-initiated phase III study (protocol V503-044-IC, NCT03525210) in HIV patients and SOT recipients One hundred HIV patients (age: 18-45 years) and 171 SOT (kidney, heart, lung transplant) patients (age: 18-55 years) were enrolled between April 2018 and January 2019 in the outpatient clinic of the University Hospitals Leuven, Belgium|
714298|NCT03509350|Participant enrollment began on August 22, 2018. Follow-up for the primary outcome measure was completed on August 22, 2019 and follow up for the secondary outcome measures was completed on January 29, 2020. Participants were recruited from multiple sites in the United States of America.|
714550|NCT03438539||
714252|NCT03525119|Participants took part in the study at 10 investigative sites in United Kingdom from 16-May-2018 to 09-Jul-2019.|Healthy participants were randomized in 1:1:1 ratio in 3 parallel groups: Group 1 received 1 dose of Hepatitis A Virus (HAV) vaccine and Tetravalent Dengue Vaccine Candidate (TDV) placebo matching injection, Group 2 received 2 doses of TDV and HAV vaccine placebo matching injection and Group 3 received 1 dose of HAV vaccine and 2 doses of TDV.
714253|NCT03524157||
714254|NCT03523988|Orthodontic patients that presented to the University of Washington Graduate Orthodontics Clinic between May 2nd and June 23rd, 2017 were approached for recruitment.|Participants were screened against a set of inclusion criteria during the informed consent process. If one or more of the inclusion were not met then the patient was not assigned to a group.
714255|NCT03522675||
714256|NCT03522506|Participants took part in the study at 1 investigative site in the United States from 09 May 2018 to 07 November 2018.|Healthy sleep deprived participants were enrolled in 1 of the 4 treatment sequences of this 4-period crossover study to receive: TAK 925 44 milligram (mg) (Low dose), TAK-925 112 mg (High dose), modafinil 300 mg, and placebo.
714257|NCT03522441||
714258|NCT03522350|Patients undergoing IVF were be recruited to participate in the study. Those agreeing to participate consented to have their embryos incubated in the new Embryoscope+ as opposed to the current one being used as standard of care.|"18 subjects will undergo IVF. Participant's oocytes at retrieval will be randomly assigned to both groups for comparison: Standard EmbryoScope system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated. Best grade embryos will be transferred regardless of EmbryoScope use."
714259|NCT03521817||
714260|NCT03521791||
714261|NCT03521141|Mailed and Phone outreach to enrolled SCCS participants.|"Begin enrollment (Baseline survey) for verbal consent, randomize on receipt of written consent. Analysis performed on randomized participants who completed the Results Call (those who began the pilot trial)."
714262|NCT03521089||
714263|NCT03520998||
714264|NCT03520959||
714265|NCT03520348||
714266|NCT03519932||Subjects were randomized to wear comfilcon A toric lenses for 1-month and samfilcon A toric lenses for 1-month in this cross-over dispensing study.
714267|NCT03519919||
714268|NCT03519867|Adult participants of American Society of Anesthesiologists (ASA) Class 1-3 who were scheduled for surgery were recruited at 4 study sites in the US.|
714269|NCT03519854|Of the N=99 randomized participants, N=98 received treatment. Treated participants are counted as Started in the arm that most accurately describes the treatment received. If no treatment was received (N=1 participant), participants are counted as Started in the arm to which they were randomized.|"One participant originally randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. As a result, this participant is counted as Started/Treated in the Arm A. Placebo; given 3 minutes after Esmeron® arm."
714270|NCT03519516||
714271|NCT03519282||Three subjects did not meet the inclusion criteria. Ten (10) subjects completed all visits and their data were included in the analysis.
714272|NCT03519243||
714273|NCT03519204||Three participants were randomized to the no-treatment control group but were treated in error on the day of randomization and were included in the treatment group for the Modified-intent-to-treat (mITT) population and the Safety population for analysis.
714274|NCT03519087||No participants were excluded from the study before assignment to groups (interdisciplinary vs. standard)
714275|NCT03518840|Patients were recruited from November 2017 through June 2019 (20 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.|
714276|NCT03518125|469 participants were screened at 4 sites in the US between May 14, 2018 - November 8, 2018, of which 305 were randomized and vaccinated between May 17, 2018 - November 12, 2018.|
714277|NCT03518008|Subjects were recruited from 1 investigative site located in the United States.|A total of 22 subjects signed informed consent to participate in the study. This reporting group includes all randomized and exposed subjects (22).
714278|NCT03516227|Participants were recruited from the neurological ward at a medical center in northern Taiwan.|Five patients did not receive the allocated group treatment protocol (two had arrhythmias after inclusion and three refused baseline measurements)
714279|NCT03515941||
714280|NCT03514966||Patients with the following were excluded: (1) dysphagia or symptoms of gastric outlet obstruction; (2) poor general condition; (3) a pacemaker or other implanted electromedical devices, or artiﬁcial heart valves; (4) pregnancy or suspected pregnancy; (5) exclusion criteria for standard magnetic resonance imaging examination
714281|NCT03513848||
714282|NCT03513757||
714283|NCT03513588||
714284|NCT03512457||
714285|NCT03512067||
714286|NCT03512041||
714287|NCT03512028||
714288|NCT03511521||
714289|NCT03511326||
714290|NCT03511105|This was a randomized, placebo-controlled, parallel group, double-blind (sponsor-open), segmental lipopolysaccharide (LPS) challenge study of GSK2798745 in healthy participants.|A total of 47 participants were randomized in the study. The study was terminated due to low probability of achieving a positive outcome on the primary endpoint.
714291|NCT03510715|The study was conducted at 10 active centers (which screened at least 1 participant) in 10 countries worldwide. Overall, 20 participants were screened between 31 August 2018 and 4 January 2019, of whom 2 were screen failures. Of the 10 centers which screened participants, 9 centers enrolled at least 1 participant.|A total of 18 participants were enrolled and received treatment in this study.
714292|NCT03510273||One woman was positive for visual inspection with acetic acid, but after enrollment was found to not have documentation of her human papillomavirus test or test result. Therefore, 320 were enrolled but only 319 participated in the study.
714293|NCT03510195||
714294|NCT03509948||
714295|NCT03509883||94 Participants Enrolled; 30 participants Randomized; Reasons Not Randomized: 43 participants no longer meet study criteria; 12 were lost to follow up 9 other; 5 screening extras: 4 back ups
714296|NCT03509766||
715471|NCT03216499|Enrollment Sept 14, 2017 - March 9, 2018, all glioblastoma multiforme (GBM) patients|
714302|NCT03508661|Scleroderma Canada and the Scleroderma Foundation were asked to generate a list of 12 interested scleroderma support group leaders. These leaders received an initial email invitation to join the study along with the consent form and the first 10 leaders to consent were enrolled in the study. Participants were recruited from February to March 2018.|One of the 10 participants who initially indicated that she would participate was hospitalized and was unable to take part before providing informed consent. This participant was replaced with one of the remaining interested support group leaders that were contacted prior to the start of the program. Thus, 10 participants were enrolled.
714303|NCT03508050||
714304|NCT03507569|Healthy subjects between the ages of 23 and 55 years (inclusive) were enrolled at one site in the United Kingdom.|
714305|NCT03507036||
714306|NCT03506425||
714307|NCT03506347||
714308|NCT03506295|"Each patient underwent TBC, and 4 samples of cryobiopsies were obtained per patient. 2 biopsies were obtained with Standard of Care procedures and 2 biopsies used the radial ultrasound probe will be used in addition to standard of care.
~All participants received both interventions."|
714309|NCT03505593||Of 48 enrolled participants, 46 met inclusion/ exclusion criteria and underwent a tube placement attempt. From these 46 participants, 43 completed a successful tube placement.
714310|NCT03505372|5 patients were recruited|
714311|NCT03505190|"Planned: Up to 50 healthy volunteers (HVs) across 5 cohorts of 10 HVs (8 active, 2 placebo) per dose-level.
~Actual: A total of 41 HVs were enrolled across 4 dose cohorts."|
714312|NCT03504189||
714313|NCT03503578||
714314|NCT03503292||
714315|NCT03503188|Multicenter, single-visit study to collect new data of participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) and symptomatic controls (non-IPF). Participants were grouped based on their diagnosis at screening. Data for main study was collected from April2018 to July2018 and for substudy from September2018 to January2019.|All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered in the trial if any one of the specific entry criteria were not met.
714316|NCT03502915||
714317|NCT03502681||
714318|NCT03502070||
714319|NCT03501693||This was a retrospective, multi-reader multi-case reader study. 18 radiologist readers read all 300 cases (half FFDM and half DBT plus S-View reads) at each of 2 visits which were separated by a memory washout period of approximately 4 weeks. Images were previously acquired under Fujifilm protocol FMSU2013-004A.
714320|NCT03501277|Participants took part in the study at 1 investigative site in Russia from 26 May 2018 to 11 July 2018.|Healthy participants were enrolled in 1 of the 4 treatment sequences to receive: SYR-322-4833 BL (25 milligram [mg] + 15 mg) (Regimen A), alogliptin 25 mg + pioglitazone 15 mg (Regimen B), SYR-322-4833 (25 mg + 30 mg) (Regimen C), and alogliptin 25 mg + pioglitazone 30 mg (Regimen D).
714321|NCT03501264||
714322|NCT03501069|Participants took part in the study at 2 investigative sites in the United States from 30 May 2018 to 26 December 2018.|Healthy female participants were enrolled to receive TAK-418 as single rising dose (SRD) dose of 120 milligram (mg), or 160 mg (non-Japanese cohort), and/or placebo in a crossover fashion; and multiple rising dose (MRD) of 20 mg, 60 mg, 160 mg (non-Japanese cohort) or 20 mg (Japanese cohort). The study was terminated early due to business decision.
714323|NCT03501043||
714324|NCT03500679||
714325|NCT03500406||
714326|NCT03500302||
714327|NCT03500289||
714328|NCT03500224|Participants took part in the study at 1 investigative site in the Netherlands from 30 April 2018 to 01 June 2018.|Healthy participants were enrolled to receive a single 60-minute intravenous infusion of 0.5 milligram (mg) TAK-954 containing a microtracer of [14C]-TAK-954.
714329|NCT03500211||
714330|NCT03500198||Total of 247 participants signed the informed consent form and out of them 27 participants were never randomized and treated, 2 were randomized but not treated. Hence 218 participants were implanted lens in the first eye, (110 in ZHR00 and 108 in ZCB00 control group).
714331|NCT03500159||
714332|NCT03499067||
714333|NCT03498560||
714334|NCT03498300||The sample size of 129 participants was calculated based on the primary objective. Randomized clinical trial on 42 seropositive participants was performed for one of the secondary objectives, which was to compare the different anti-PT IgG at delivery among seropositive participants who received Tdap to those who received Td.
714335|NCT03498287||
714336|NCT03498196||
714337|NCT03497845||
714338|NCT03497585|"For the feasibility study, patient recruitment occurred between 21st May 2018 and 3rd September 2019. Patients were recruited from those referred to a rehabilitation programme within a physiotherapy-led, out-patient service in a National Health Service (NHS) Trust in Northern England.
~The acceptability interviews involved patients (as above) and healthcare professionals (HCPs) delivering the programmes. HCP recruitment occurred between 18th September 2019 and 6th November 2019."|This was a single-arm feasibility study. All patients received the same treatment, that is, they all attended the same rehabilitation programme that was underpinned by the activity pacing framework. Excluded from the study were those patients who did not meet the inclusion/exclusion criteria.
714339|NCT03497130||
714340|NCT03497039|The study was conducted at 4 sites in the United Kingdom and 1 site in Germany.|A total of 47 participants with osteoarthritis were enrolled out of which 46 were randomly assigned in 2 arms either to receive Diclofenac Diethylamine (DDEA) 2.32 percent (%) gel treatment or placebo gel. 1 participant withdrew consent before starting treatment.
714341|NCT03496987|Inpatients, who were awake, consentable, and undergoing unilateral thoracentesis|
714342|NCT03496974||
714343|NCT03496428|be at least 18 years of age; have at least one implant in the anterior maxilla with the indication for rehabilitation with a definitive implant supported crown; have two mesial and two distal adjacent teeth to the implant and be rehabilitated with a provisional implant supported crown for at least 3 months.|
714344|NCT03496324|Study was conducted in single-site in the United Kingdom.|Total 71 subjects were screened. Of these, 38 subjects were screen failures, 2 were withdrew consent, 7 were reserve subjects. Subjects randomized were 24.
714348|NCT03494985|Participants were recruited from 2 sites in United States of America.|467 participants were screened, out of which 45 were not randomized to the study. 15 did not meet study criteria, 8 were lost to follow-up, 19 withdrew their consent, and 3 were due to other reason (not specified). 422 were enrolled in the study out of which 26 did not meet eligibility criteria. Remaining 396 started the study.
714349|NCT03493854||A total of 607 patients were screened, 500 of whom were randomized.
714350|NCT03493828||
714351|NCT03493815||
714352|NCT03493698||Each subject was expected to complete treatment groups A, B, C and D; sequentially.
714353|NCT03493542||
714354|NCT03493386|A single center, single dose, open-label, randomized, 2-way crossover study in healthy Japanese male participants to evaluate the bioequivalence of daprodustat tablets, study was conducted at one center in Japan.|Total 64 healthy participants were enrolled in the study which was conducted from 24-April-18 to 09-June-18, study was conducted in two parts, Part 1 was the bioequivalence of daprodustat Tablets and part 2 was food effect on the pharmacokinetics (PK) of daprodustat.
714355|NCT03492554||
714356|NCT03492398||
714357|NCT03492099||
714358|NCT03491917||This was a retrospective, multi-reader multi-case reader study. Six (6) radiologist readers read all 100 cases (half FFDM and half DBT plus S-View reads) at each of 2 visits which were separated by a memory washout period of approximately 4 weeks. Images were previously acquired under Fujifilm protocol FMSU2013-004A.
714359|NCT03491891||
714360|NCT03491800||
714361|NCT03491553|Participants were enrolled at study sites in New Zealand and the United States. The first participant was screened on 6 April 2018. The last Week 48 study visit occurred on 06 September 2019.|59 participants were screened. Data submitted represent interim analysis performed on data collected by the Primary Completion Date, March 2019, and additional data collected through September 2019. Complete data will be submitted in August 2021.
714362|NCT03491228||
714363|NCT03491150|The study was conducted at 66 centers in 16 countries.|A total of 149 participants were enrolled at 66 centers. These 149 participants represented the Safety Analysis population and data for this population is presented here.
714364|NCT03490916||
714365|NCT03490110||
714366|NCT03490032|This study was conducted at 5 centers in the USA (Phase I: 1 site; Phase II: 4 sites)|
714367|NCT03489863||
714368|NCT03489720||Two participants were randomized to intervention arm followed by control arm. These participants withdrew from the study after the start of the intervention arm and never started the control arm.
714369|NCT03489551||
714370|NCT03489304||
714371|NCT03488927||
714372|NCT03488108||
714373|NCT03488030|Participants took part in the study at 7 investigative sites in Argentina from 12 December 2018 to 31 May 2019.|Participants diagnosed with moderate to severe Inflammatory Bowel Disease (IBD)- Crohn's disease (CD) or ulcerative colitis (UC) were observed on Day 1 with retrospective data collection for previous 3 years.
714374|NCT03487588||
714375|NCT03486990|Participants took part in the study at 5 investigative sites in the United States from 23 January 2018 to 22 July 2019.|Participants diagnosed with celiac disease (CD) were enrolled to receive TIMP-GLIA as a single dose escalation of 0.1 milligram per kilogram (mg/kg), 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg, 8.0 mg/kg in Part A; and TIMP-GLIA as a two dose escalation of 2.0 mg/kg, 4.0 mg/kg, 8.0 mg/kg in Part B.
714376|NCT03486392||A total of 474 participants were randomized out of which 444 participants completed the study.
714377|NCT03485976||
714378|NCT03483896||
714379|NCT03483623||North Atlantic Treaty Organization (NATO) and Warrior Evacuation Litter Pad (WELP); NATO and Fluid Immersion System (FIS) mattress; Raven 90C litter and WELP; Raven 90C and FIS
714380|NCT03483051||"1 subject withdrew consent prior to treatment
~1 subject screen failed"
714381|NCT03482973||80 Participants signed consent and none of the participants was withdrawn prior to randomization.
714382|NCT03482882||
714383|NCT03482713||
714384|NCT03482583||
714385|NCT03482453|Participants took part in the study at 1 investigative site in the United States from 28 March 2018 to 18 January 2019.|Healthy participants were enrolled in this 3 parts study to receive: TAK-788 as a single rising dose of 20 milligram (mg), 40 mg, 80 mg, 120 mg, 160 mg in Part 1; TAK-788 in a 2-way cross-over design with or without a low-fat meal in Part B; or in a 2-way cross-over sequence to receive TAK-788 drug in capsule (DiC) A or B in Part 3.
714386|NCT03482011||
714387|NCT03481816||
714388|NCT03481309||
714389|NCT03481270|We recruited 1374 black men in barbershops and flea markets to take the baseline survey. The subjects were given a coupon which allowed them entrance to the clinic.|1374 participants were recruited and completed the baseline survey prior to coming to the clinic. 667 filled out the baseline survey but did not come to the clinic and were not randomized. 70 additional participants were excluded from participation and were not randomized.
714390|NCT03480919||
714391|NCT03480841|Interest letters describing the study were mailed from the Part C research partner to mothers in April -June 2018. Interested mothers contacted the research team by phone or email, and were then screened for eligibility. Eligible mothers completed consent forms at their homes with researchers during the Baseline visit.|
714392|NCT03480802|Adults 18 years of age or older infected with human immunodeficiency virus (HIV) who did not receive a pneumococcal vaccine prior to study entry were enrolled in this study.|
714393|NCT03480750|Between September 1, 2012 and October 30, 2015, eligible patients were enrolled in a medical center, National Cheng Kung University Hospital.|
714394|NCT03480425||
714395|NCT03480152|No participants were enrolled on Dose Level 1 - 0.04mg vaccine, nor Cohort 2a/2b, Arm 2, Phase II Maximum Tolerated Dose Arm/Group. Participants vaccination started on Dose Level 2 - 0.13 mg.|Two step registration process. Step One: Patient signed consent to create vaccine. Step Two: Once vaccine is available, patient screened for eligibility criteria. If eligibility criteria were met, registration and enrollment was completed and the patient was treated. One patient died between Step one and Step two and was not treated.
714396|NCT03480048||
714397|NCT03480009||
714398|NCT03479944||Of the 57 enrolled subjects, 2 subjects discontinued the study before surgery on the first operated eye. This reporting group includes all subjects for which cataract surgery was performed with the test device (regardless of success or failure) (Treatment-Emergent Safety Analysis Set)
714399|NCT03479216|"History of cardiac, hepatic or renal disorders, diabetes mellitus, chronic pain treatment, contraindication to/refusal of spinal anesthesia, a known allergy to the study drugs, or who refused to participate in the study were excluded.
~(10 patients excluded: 5 declined regional anesthesia, 4 had diabetes mellitus,1 failure of regional anesthesia)"|52 patients aged between 18 and 65 years with ASA I or II who were scheduled for elective arthroscopic meniscectomy under spinal anesthesia were included in this prospective, randomized, double-blind study.
714400|NCT03478956||A total of 30 patients were screened and 6 failed screenings, 2 due to administrative reasons and 4 due to failure to meet exclusion criteria; a total of 24 participants were enrolled in the study.
714401|NCT03478891|Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland|
714402|NCT03478696|This was a randomized, multicenter, double blind, parallel group study where participants with chronic obstructive pulmonary disease (COPD) were randomized to receive either fluticasone furoate/umeclidinium/vilanterol or budesonide/formoterol plus tiotropium in a 1:1 ratio. The study was conducted across 60 centers in 3 countries.|A total of 1120 participants were screened in the study, of which 289 participants failed during screening. Of the 831 participants who entered the run-in period, 99 participants were run-in failures. A total of 732 participants were randomized and received randomized treatment.
714403|NCT03478683|This was a randomized, multicenter, parallel group study where participants with chronic obstructive pulmonary disease (COPD) were randomized to receive either fluticasone furoate/umeclidinium/vilanterol or budesonide/formoterol plus tiotropium in a 1:1 ratio. The study was conducted across 65 centers in 4 countries.|A total of 1036 participants were screened in the study, of which 215 failed during screening. Of the 821 participants who entered the run-in period, 92 were run-in failures. A total of 729 participants were randomized in the study, of which one participant was randomized in error. A total of 728 participants received randomized treatment.
714404|NCT03478657|This was a multi-center, single arm, stratified, open-label, randomized placebo-only study conducted in pediatric participants. Participants were stratified based on age at Visit 0 (Stratum 1: 5 to 7 years old inclusive and Stratum 2: 8 to 11 years old inclusive).|A total of 232 participants were screened, of which 10 failed screening and 222 participants were enrolled in the study. The study was conducted in the United States and Canada.
714405|NCT03478644|All participants were recruited at one center in the United States.|A total of 155 participants were screened, of which first 31 eligible participants with complete upper dentures were included in Phase 1 (food removal testing). Out of 155 participants, 152 were randomized in Phase 2 (oral soft tissue and dermal assessment). 3 participants were not randomized as 2 were screened failure and 1 withdrew from study.
714406|NCT03478371||
714407|NCT03477903|One participant took part in the study at an investigative site in the United States from 25-Aug-2018 to 29-Aug-2018.|One participant with a diagnosis of Enteral Feeding Intolerance (EFI) was enrolled and received 0.1 mg of TAK-954. No participants were enrolled in the other 3 planned arms of the study.
714408|NCT03476850||
714409|NCT03476278||
714410|NCT03476239|"This is an ongoing study conducted at 23 centers in China. Overall 121 participants were enrolled.
~The data cutoff date for the primary analysis reported is 12 April 2019; 106 participants enrolled prior to the data cutoff date.
~The study includes a treatment period, a safety follow-up (SFU) visit 30 days after last dose and a follow-up period."|"The data cutoff date of 12 April 2019 allowed for the protocol-specified 90th participant enrolled before 21 February 2019 to have had the opportunity to complete 2 cycles of treatment and the SFU visit (if discontinued treatment after 2 cycles).
~Data are not available for the 15 participants who enrolled between 21 February 2019 and 12 April 2019."
714411|NCT03476135|The study was conducted at 8 sites in Finland from 27 February 2018 to 10 September 2018.|A total of 91 participants who received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine or Nimenrix® vaccine in previous study MET54 (NCT03205358) were enrolled in this study (MET62).
714412|NCT03475875|A total of 92 subjects were enrolled into this study. Of those enrolled, 91 were dispensed a study lens and 1 subject failed to meet the eligibility criteria. Of the dispensed subjects 83 completed the study while 8 subjects were discontinued.|
714413|NCT03474874||
714414|NCT03474172|All the recuitment work conducted at the outpatient department of pediatrics of Kanghua hospital where is a first class western medical hospital between May.2018 to August.2018.|
714415|NCT03474081|This was a randomized, multicenter, parallel group study where participants with chronic obstructive pulmonary disease (COPD) were randomized to receive either fluticasone furoate/umeclidinium/vilanterol or tiotropium in a 1:1 ratio. The study was conducted across 68 centers in 3 countries.|A total of 1049 participants were screened, of which 179 failed screening. Total of 870 participants entered in run-in period, of which 70 were run-in failures. Total of 800 participants were enrolled and randomized.
714416|NCT03473886||
714417|NCT03473808||
714418|NCT03473665||This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
714419|NCT03473236||
714420|NCT03473197||
714421|NCT03473184||
714422|NCT03473171||
714423|NCT03472547||
714424|NCT03472534||This does not apply
714425|NCT03472287||
714426|NCT03472014||
714427|NCT03471975||
714428|NCT03471871|Participants took part in the study at 8 investigative sites in the United States from February 21, 2018 to August 3, 2018.|In healthy volunteer (HV) cohort, 39 participants were screened and enrolled, of which 22 were screen failures, 17 were randomized to receive treatment. In obstructive sleep apnea (OSA) cohort, 107 participants were screened and enrolled, of which 68 were screen failures, 39 were randomized to receive treatment. Total participants enrolled=146
714429|NCT03471832||
714430|NCT03470740||
714431|NCT03470012|Subject recruitment occurred between 1/16/2018 and 1/23/2018.|
714432|NCT03469349|Participants took part in the study at 19 investigative sites in Russia, Kazakhstan and Georgia from 01 May 2018 to 28 August 2019.|Participants with peripheral arterial occlusive disease (PAD) Fontaine stage IIB were enrolled in this study to receive either actovegin or placebo in a 1:1 ratio.
714433|NCT03469336||Of 26 participants screened for entry into the study, 4 participants failed at Screening and 4 participants were eligible at Screening but were not randomized in the study, and the remaining 18 participants were assigned to the study treatment.
714434|NCT03469258||
714435|NCT03468920||
714436|NCT03468855||
714437|NCT03468816|"61 patients were screened for eligibility between May 2018 and December 2019 at the Dermatology department at University Hospital in Linköping, Sweden and 2 of these patients were enrolled.
~3 patients were screented for eligibiity and enrolled between July 2019 and December 2019 at S2Clinic in Linköping, Sweden."|Each enrolled participant used both investigational device Variant A and Variant B in either the order A-B-A or B-A-B according to a pre-designed schedule to ensure equal numbers in the two study arms. All 5 enrolled participants completed the study.
714438|NCT03468543||
714439|NCT03468179||
714440|NCT03468075||
714441|NCT03467971||
714442|NCT03467945||
714443|NCT03467763||Please note that results have been presented in a single study arm as the order in which participants received drug or placebo was unique for many patients, so that reporting a separate arm for each sequence of drug and placebo exposure would have resulted in reporting individual level results, potentially compromising patient confidentiality.
714444|NCT03467685||
714445|NCT03467477|Enrollment occurred between Mar 2018 and Nov 2018. Recruited subjects with clinically diagnosed early AD who were interested in participating in AD therapeutic clinical trials being conducted by Eli Lilly and Company.|
714446|NCT03467425|This was a Phase IV, open-label, randomized study to evaluate the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA multiple inhaler triple therapies (MITT) for chronic obstructive pulmonary disease (COPD) control within the usual clinical practice setting. TRELEGY and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.|A total of 3341 participants were screened and 3109 participants (Par.) were enrolled in this study. Of which, 3092 participants were randomized and received the study treatment. The remaining 17 participants were randomized in error (those who were recorded as screen failures and also randomized) and did not receive investigational product (IP).
714447|NCT03467412||Each subject received 2 dose strengths on 2 separate areas locally applied on the scalp. Thus, 120 treatment areas were defined in the trial but only 60 subjects participated. The number of participants in each arms are not unique subjects since each subject will appear in 2 arms. The total number of participants in the trial is 60.
714448|NCT03467048||
714449|NCT03466918|Each study site was allowed up to two roll-in patients. Per the protocol, roll-in patients completed all study visits and procedures but were not part of the analysis. Eight of the 58 patients enrolled were roll-in patients.|
714450|NCT03466658|Participants were recruited in the Penn State Health Orthopedics Clinic for indications of open or arthroscopic shoulder surgery.|17 participants met inclusion criteria and were enrolled. 3 participants withdrew prior to study intervention.
714451|NCT03466099||130 Patients were randomized but one patient withdrew prior to receiving any study treatments
714452|NCT03466086|A total of 57 subjects were enrolled in this study, of which 55 subjects were assigned to receive at least 1 eye drop while, 2 subjects were screen failures and/or not assigned. Of the total assigned subjects, 53 subjects completed the study and 2 subjects discontinued the study.|
714453|NCT03466073||
714454|NCT03466060|A total of 130 subjects were enrolled into this study. Of those enrolled, 113 subjects were assigned and dispensed a study lens while, 15 subjects were screen failures and 2 subjects were assigned but not administered the Test article. Of those dispensed, 106 subjects completed the study while, 7 subjects were discontinued.|Of those that completed the study, 78 subjects completed without a major protocol deviation impacting a primary endpoint.
714455|NCT03466047||
714456|NCT03465904||
714457|NCT03465878|Participants (pts) who completed Part A but discontinued before the beginning of Part B were replaced by newly enrolled participants in Part B.|Two period crossover study, with a minimum of 22 days washout period between each period.
714458|NCT03465735||
714459|NCT03465709|Male and female subjects aged at least 60 years with a clinical diagnosis of neovascular age-related macular degeneration in the study eye were recruited to this Phase 1b/2, open-label study at 3 study centers in the United States conducted from 14 February 2018 until the last subject last visit on 05 April 2019.|Subjects who demonstrated a reduction in excess macular fluid or macular thickness based on spectral domain optical coherence tomography (SD-OCT) comparison between Screening Visits 1 and 2, and who were eligible received a first anti-vascular endothelial growth factor (anti-VEGF) injection at Visit 2 and a second one at baseline (Day 1, Visit 3).
714460|NCT03465436||All randomized participants who received at least 1 dose of study drug.
714461|NCT03464383||
714462|NCT03463941||
714463|NCT03463512||
714464|NCT03463161||
714465|NCT03463031||
714466|NCT03462927|First Subject First Visit: 08Feb-2018. Last Subject Last Visit: 04-Aug-2018.|Prior to randomization, the subject entered a washout period (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The washout/screening period lasted for up to 4 weeks depending on which disallowed treatments the subject received.
714467|NCT03462745||
714468|NCT03461757|The study was conducted at 69 centers in the United States.|Total 1811 participants were enrolled, of which 1466 were randomized to rimegepant 75 milligram (mg) orally disintegrating tablet (ODT) or placebo. Total 345 participants failed screening mainly due to failure to meet eligibility criteria. Randomization was stratified in 1:1 ratio based on use of prophylactic migraine medications (yes or no).
714469|NCT03461705||
714470|NCT03460990|A total of 116 participants were enrolled in the study, of which 5 participants were included in the run-in period but were not dosed in TC treatment period. Results are presented for 111 participants dosed in the TC treatment period.|This study was conducted in participants with cystic fibrosis (CF) aged 12 years or older.
714471|NCT03460899|"Recruitment period: Approximately 3 Months (End of February until beginning of May 2018)
~Recruitmet process: Subjects were recruited by using a local recruitment registry."|
714472|NCT03460587||
714473|NCT03459794||
714474|NCT03459612||Randomized, 4-period cross-over study in healthy participants.
714475|NCT03459196|A total of 54 subjects were enrolled in the study at 7 sites in Europe. The first subject was enrolled on April 17th, 2018 and the last subject was enrolled on June 20th, 2018.|Subjects were screened carefully prior to enrollment in the study to ensure compliance with the inclusion and exclusion criteria. All subjects were screened using pre-procedure imaging for the presence of LA thrombus, which was intended to decrease the potential for thromboembolic complications.
714476|NCT03459131|Subjects were recruited from one study site located in the US.|All 15 enrolled subjects were randomized and exposed to investigational product. This reporting group includes all randomized and treated subjects (15).
714477|NCT03458871||
714478|NCT03458702|We recruited women from yoga classes at the university.|Qualified participants were asked to track their menstrual cycle using a menstrual log and e-mail the primary investigator on day 1 of the follicular phase of their menstrual cycle. The participant was then scheduled for condition A first or condition B first.
714479|NCT03457909|Healthy volunteers or patients with suspected esophageal diseases were prospectively enrolled in Changhai Hospital from March 2018 to June 2018.|This study was a prospective, self-controlled, single-centered pilot study. After enrollment, each enrolled subject first underwent DS-MCE(detachable string magnetically controlled capsule endoscopy), and subsequently EGD(esophagogastroduodenoscopy) within one week.
714480|NCT03457727|This two-part study assessed the relative bioavailability of Danirixin (DNX) tablet formulations along with effect of food and gastric acid secretion suppression on DNX pharmacokinetics. This study was conducted at a single center in the United States from 07-Mar-2018 to 25-Jul-2018.|Danirixin hemihydrate salt tablet formulation manufactured using roller compaction (RC) was compared to test formulations manufactured by direct compression (DC) with an excipient hydroxypropyl methylcellulose (HPMC) to evaluate the most appropriate formulation/dosing regimen. A total of 40 participants were enrolled in the study.
714481|NCT03457636||
714482|NCT03456960|Participants took part in the study at 1 investigative site in Japan from 8 March 2018 to 12 October 2018.|Healthy male participants were enrolled in this 2-period cross-over design study to receive 1 of the 2 treatment sequences: fixed dose combination (FDC) of TAK-438 and aspirin (TAK-438ASA) or a free combination of TAK-438 and aspirin in Study 1, and to receive 1 of the 2 sequences: FDC of TAK-438ASA under fasted or fed conditions in Study 2.
714483|NCT03456856|A total of 30 participants were enrolled at 2 centers in the United States.|
714484|NCT03456700||
714485|NCT03456427||
714486|NCT03456245||
714487|NCT03455556|One (1) patient was recruited from August 2018 to September 2019 at Mayo Clinic. This trial was permanently closed on September 11, 2019. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|
714488|NCT03455543||Protocol Sample Size was anticipated at 170 subjects. The original enrollment target of 170 subjects was exceeded to grant study entry to qualified subjects that completed the 14-day run-in period.
714489|NCT03455491|Patients receiving both in- and outpatient treatment could be enrolled.|"A total of 121 patients were screened to participate in the trial; one patient was withdrawn at screening.
~120 patients were randomly assigned into 3 groups."
714490|NCT03455218||
714491|NCT03454581|Recruitment and follow-up assessment: May 2016 to November 2016. Location: Participants were recruited from patients referred to the Department of Buco Maxillofacial Surgery and Traumatology and to the Department of Conservative Dentistry at Federal University of Rio Grande do Sul, Porto Alegre,Brazil.|"Fifty-one participants were enrolled and randomized into 3 groups. Inclusion criteria: myogenic and arthrogenic temporomandibular dysfunction, pain and mouth movement limitation.
~Exclusion criteria: Dental therapy; rheumatic diseases, use of anti-inflammatory and muscle relaxant."
714492|NCT03454048||
714493|NCT03453515||
714494|NCT03453151||
714495|NCT03453060||A total of 132 participants were screened for the study, of which 111 did not meet eligibility criteria, declined to participate, or were dropped alternates. The remaining 21 participants were randomized into the study, with each dose level occurring in sequential order.
714496|NCT03452943||A total of 119 participants were randomized in a 1:1 ratio to either TEV-50717 or placebo group.
714497|NCT03452371||
714498|NCT03452176||
714499|NCT03451721|The recruitment was finished on 27Dec2018 and total 20 patients enrolled in study|
714500|NCT03450369||
714501|NCT03450070||There were 121 subjects enrolled. 3 of those subjects were disconinued prior to being patched due to screen failure. Therefore, 118 subjects started using patches.
714502|NCT03449979||
714503|NCT03449758|The study was conducted at 31 active centers in France. A total of 104 participants were screened between 05 March 2018 to 27 December 2018, of which 20 were screen failures. Screen failures were mainly due to inclusion criteria not met.|A total of 84 participants were enrolled and received treatment.
714504|NCT03449446|Participants were enrolled at study sites in United States, Australia, Canada, Hong King and New Zealand. The first participant was screened on 21 Mar 2018. The last study visit occurred on 19 Nov 2019.|950 participants were screened.
714505|NCT03449433||
714506|NCT03449342|The trial was conducted at 10 sites in India.|
714507|NCT03448536|Study was conducted at multiple centers in the US between 05 April 2018 (first patient first visit) and 05 September 2018 (last patient last visit).|Overall, 242 participants were screened. Of them, 201 participants were randomized, and 196 received study treatment.
714508|NCT03448419|Randomised, double-blind, placebo-controlled, parallel-group trial in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF) to evaluate the effect of Empagliflozin versus Placebo on exercise and heart failure symptoms.|Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.
719019|NCT02687529||
719020|NCT02687412||
719021|NCT02687217||
714509|NCT03448406|Randomised, double-blind, placebo-controlled, parallel-group trial in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF) to evaluate the effect of Empagliflozin versus Placebo on exercise and heart failure symptoms.|Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.
714510|NCT03448224|Qualtrics Sample Providers emailed advertisements for an online screening survey to members of internet panels and posted online advertisements. Recruitment flyers with contact information were posted on campus and in classrooms and on internet ads on social media and Craigslist. Baseline assessments were completed between April and November 2018|One participant removed after assignment because of failed quality check with baseline data.
714511|NCT03447821||
714512|NCT03447730||
714513|NCT03447639|Patients were recruited from the inpatient units of the hospital.|
714514|NCT03447353||
714515|NCT03447249|A total of 385 participants were enrolled in the study, of which 3 participants were enrolled but were not dosed in the TC treatment period. Results are presented for 382 participants dosed in the TC treatment period.|This study was conducted in participants with cystic fibrosis (CF) aged 12 years or older.
714516|NCT03447015||
714517|NCT03446846||
714518|NCT03446781||
714519|NCT03446690||
714520|NCT03446573|This non-inferiority study evaluated antiviral activity of switching to dolutegravir (DTG) + lamivudine (3TC) fixed dose combination (FDC) once daily compared to continuation of a Tenofovir alafenamide (TAF)-based regimen (TBR) over 48 weeks in virologically suppressed participants with human immunodeficiency type 1 infection.|743 participants were enrolled, of which two participants did not receive treatment and hence 741 participants received at least one treatment into the study. The results presented are based on Week 48 primary analysis.
714521|NCT03445390||
714522|NCT03445195||
714523|NCT03445156|Participants were college students who completed the study as part of a course requirement.|After giving their consent, participants completed a survey. Next, they were randomly assigned to play either a violent First-Person-Shooter video game or a nonviolent shooting video game for 20 minutes. Video game play was recorded. A debriefing followed.
714524|NCT03444766||100 participants treated
714525|NCT03444584|The study was conducted in Germany and Hungary between 08May2018 and 06Dec2018.|
714526|NCT03444090||
714527|NCT03443713||
714528|NCT03443427||
714529|NCT03443414|405 adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) were randomized into this double-blind, multicenter study, and 403 received study medication. Patients were recruited to 47 study centers in Bulgaria, Czech Republic, Germany, Poland, Romania and the United Kingdom.|Patients with a clinical diagnosis of COPD as defined by the American Thoracic Society/European Respiratory Society guidelines with symptoms compatible with COPD for at least 1 year prior to screening, and with clinically stable symptoms in the 4 weeks prior to screening and randomization were screened for inclusion.
714530|NCT03443063|Participants took part in the study at 2 investigative sites in the United states from 07 February 2018 to 24 August 2018.|A total of 48 participants were screened, of which 32 were screen failures and 16 were enrolled and received study treatment.
714531|NCT03442933|In total, 40 participants were randomly assigned to their Arm/Group, in which the intervention was administered in 2 different sequences of intervention: 1) Road Cycling first, then Mountain Biking; and 2) Mountain Biking first, then Road Cycling.|They were required to attend on 2 different occasions to our installation, both spaced a week apart as washout.
714532|NCT03442868|Participants were recruited from Dallas Fort Worth metro area. Recruitment started in October 2016 and last participant was enrolled in Oct 2018.|
714533|NCT03442829||
714534|NCT03442725|A total of 16 subjects were recruited in this open label, single dose study between February and May 2018. Recruited subjects were split evenly between 2 groups (control group and test group).|The control group comprised 8 healthy subjects with normal renal function and who were demographically matched to test group by age (±10 years), sex and body mass index (BMI) (±20%). 8 subjects with severely impaired renal function but not requiring dialysis were recruited into the test group.
714535|NCT03442699||8 participants were consented. Two were excluded for comorbid substance use disorder. 6 participants initiated treatment.
714536|NCT03442595||
714537|NCT03442036|Subjects undergoing painful foot/ankle surgery at UCSD were recruited to the study. Total enrollment = 70 subjects.|
714538|NCT03441984|This was a 2-Part, Phase I, Single-Dose, 3-Period Crossover Relative Bioavailability Study of a Pediatric TRIUMEQ Dispersible Tablet and Pediatric Dolutegravir and Lamivudine (DTG/3TC) Fixed Dose Combination Dispersible Tablet Formulations as Compared with Adult Tablets in Healthy Participants.|A total of 36 participants were enrolled for Part 1 and 2 of the study at a single-center in the United States. Each participant received all 3 treatments according to their assignment to one of the 6 treatment sequences in Part 1 and 2.
714539|NCT03441789||1 participant signed consent but failed screening
714540|NCT03441633||
714541|NCT03441594||
714542|NCT03441269||
714543|NCT03441178||Planned on 100 enrolled but 101 was enrolled due to timing and study closure.
714544|NCT03440918|"528 patients in the pediatric ICU were on antibiotics < 1 calandar day and were assessed for eligibility during the study period, February 15, 2018 to April 11, 2019.
~257 were excluded and did not undergo randomization."|No patients enrolled in the study were excluded before assignment to groups.
714545|NCT03440619||
714546|NCT03440424|Participants took part in the study at 2 investigative sites in the United States from 26 January 2018 to 23 April 2018.|A total of 28 participants were screened, of which 4 were screen failures, and 24 were enrolled and received the study treatment.
714547|NCT03439124||All 138 randomized patients received treatment
714548|NCT03439072|The recruitment period began 08 Jan 2018 and ran through 02 Apr 2018. Subjects were screened for study eligibility at one of the six clinical sites up to 30 days prior to randomization.|A total of 81 eligible subjects were randomized to treatment. However, two subjects withdrew consent prior to dosing, so the number of subjects exposed to study treatment was 79.
714551|NCT03438383|Τhis prospective randomized single-blinded study with a control group was conducted in a tertiary urban Greek hospital. Subjects recruitment was performed at the respective departments of obesity surgery where subjects underwent surgery, also belonging to tertiary hospitals.|Exclusion criteria included cardiovascular and pulmonary disease not related to obesity status, and chronic renal disease. From the 48 patients initially enrolled in the study, 1 was excluded from the participant flow because of recent onset of cardiovascular disease. 47 patients were assigned to the study groups.
714552|NCT03438266|A total of 66 participants were enrolled in the study and 6 were excluded as screen failures. Only 60 participants were randomized and received study treatment.|
714553|NCT03437733||
714554|NCT03437564|Participants took part in the study at 1 investigative site in Japan, from 16 February 2018 to 13 April 2018.|Healthy participants were enrolled in one of two treatment group (vortioxetine 20 mg (1×20 mg tablet) on Day 1 in Period 1, followed by vortioxetine 20 mg (2×10 mg tablets) on Day 1 in Period 2; vortioxetine 20 mg (2×10 mg tablets) on Day 1 in Period 1, followed by vortioxetine 20 mg (1×20 mg tablet) on Day 1 in Period 2) with cross over design.
714555|NCT03437447||
714556|NCT03436732||1/5 participants enrolled was a screen failure following enrollment.
714557|NCT03436420|Children were recruited from the patient population of Children's Healthcare of Atlanta, in Atlanta, Georgia. Enrollment began on March 29, 2018 and study follow up was completed on August 27, 2019.|
714558|NCT03436147||
714559|NCT03435783||
714560|NCT03435562||
714561|NCT03435497||1 control was withdrawn because she was exposed to the intervention after randomization. Of the 98 remaining, 1 control did not provide any follow-up data due to moving away from the study area. 4 participants who provided first follow-up data did not provide last follow-up data (2 intervention, 2 control). Retention rate=99%
714562|NCT03435185||16 patients were excluded due to not meeting inclusion criteria
714563|NCT03434977|Participants took part in the study at 1 investigative site in Japan from 14 February 2018 to 11 March 2018.|Healthy male participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive pediatric formulation of TAK-536 10 milligram (mg) granules under fasted or fed condition.
714564|NCT03434457||
714565|NCT03434249|"The study was a randomized, double-blind, placebo-controlled parallel-group study. Eighty (80) infants were screened and all were enrolled in the study and randomized (40 to Bifidobacteriium BB-12® and 40 to Placebo).
~The enrollment period started on 11-Nov-2016 and closed on 6-Nov-2017."|
714566|NCT03434119|The study was conducted at 94 sites in United States (US). A total of 534 participants were screened between 20 February 2018 and 01 November 2018, of which 293 participants were screen failures. Screen failures were mainly due to glycated hemoglobin A1c (HbA1c) level less than (<)7.5% or greater than (>)10% at the screening visit.|Randomization was stratified by self-reported ethnic/racial group, screening HbA1c values (<8.5% vs >=8.5%), background use of sodium-glucose co-transporter-2 (SGLT-2) inhibitors (yes/no), background use of sulfonylureas (yes/no). Assignment to arms was done centrally by an interactive response technology (IRT) in 1:1 ratio (Soliqua 100/33:Lantus).
714567|NCT03433794||Participants read study description and eligibility criteria, and signed up to attend a baseline session. Upon joining the study and completing an informed consent document, they were randomly assigned to arm/group of the study. After completing the online survey, 26 individuals were identified as ineligible and not enrolled.
714568|NCT03433703|Participants took part in the study at 3 investigative sites in the United States from 26 April 2018 to 07 January 2019.|A total of 8 participants were enrolled, of these, 6 were screen failures and 2 were treated. Upon completion of lenvatinib treatment, eligible participants were to receive commercially available systemic treatment of physician choice (TPC). However, because of early termination of study no participants received TPC.
714569|NCT03433677||2-period crossover with no washout between periods and a 4 week safety follow-up.
714570|NCT03432533|Participants were enrolled at 36 centers in Poland, United Kingdom, and United States.|Participants were randomized in a 1:1 ratio.
714571|NCT03432390|Patients were recruited at the Teaching Hospital of the Federal University of Pernambuco|Ninety-eight patients were screened for the purpose of determining eligibility; seventy-two were enrolled, twenty-six were not due to not meeting the inclusion criteria [ASA >2,(01); Not Preschool-aged (21)], meeting the exclusion criteria [current upper respiratory tract infection(03)] or not signing the written informed consent (01)
714572|NCT03431441|A total of 26 subjects were enrolled in the study. Of those enrolled, 24 subjects were assigned and administered. Of the total assigned subjects, 19 subjects completed the study, while 5 subjects were discontinued from the study.|
714573|NCT03431012||Of 349 submitted questionnaires, 30 were incomplete and 103 were deemed to be invalid, leaving to analyse 216 valid questionnaires.
714574|NCT03430986||
714575|NCT03430856|Out of 20 sites, which were selected for recruitment, 19 sites enrolled subjects in the run-in period, of which 15 sites later assigned subjects to randomized treatment: India:20 sites|The trial included an 8-week run-in period and a 24-week treatment period. During the run-in period, the subjects received insulin glargine along with metformin. In total, 143 subjects entered the run-in period, of these 52 subjects were run-in failures. Hence, 91 subjects were randomly assigned to each treatment arm.
714576|NCT03430245||
714577|NCT03430206||
714578|NCT03430050||
714579|NCT03429712||
714580|NCT03429556||
714581|NCT03429270||
714582|NCT03428997||
714583|NCT03428750||
714584|NCT03428152||
714585|NCT03427931||
714586|NCT03427892|This study enrolled patients recruited through flyers and other forms of advertisement. Patients met DSM-5 criteria for bipolar I or II disorder, with a current moderate to severe depressed mood state. The last patient completed on March 15, 2018.|Of the 30 patients consented and screened during the duration of the study between March 2017 and December 2017, 9 screen failed and 21 were enrolled within the study. The study was non-randomized and all patients received the same study condition.
714673|NCT03401671|The study was conducted in the United States between 15 January 2018 (first participant first visit) and 30 May 2018 (last participant last visit).|A total of 32 participants were enrolled, received the treatment and completed the study.
714674|NCT03401450||
714587|NCT03427073|Recruitment was carried out in three study sites in Belfast, Manchester and Newcastle, UK starting on 27 April 2015.|Part 1 enrolled adult patients with advanced solid tumours in whom treatment with an anti-angiogenic agent was appropriate. Participants had screening evaluations between Day -1 and -28 before entering the first 21-day treatment cycle.
714588|NCT03426995|This was a randomized, double-blind, placebo-controlled, 3-part study. Part A was single ascending dose crossover with 2 interlocking cohorts(1 and 2);Part B was planned to be a single dose, open-label, 2-way crossover in fed, fasted conditions(Cohort3);Part C was repeat dose design in sequential cohorts(4,5) and cohorts 6 to 8 were planned.|A total 48 participants were enrolled in this study. Part B and Part C (Cohorts 6 to 8) were not initiated as the study was terminated early due to strategic reasons following emergence of new data. Hence, no participants were enrolled in Part B and Part C (Cohorts 6 to 8).
714589|NCT03426787||
714590|NCT03426631||
714591|NCT03426566|Recruitment period: between October 2009 and December 2010 Medical records were obtained from the Diabetic Foot Centre (DFC) in Wroclaw, Poland and covered a period of fifteen months of work.|Patients without previous ulcerations or foot surgery were evaluated.
714592|NCT03426436||
714593|NCT03426137|Three participants were consented from University of Maryland Shock Trauma Center, per protocol, between 3/17/2019 to 3/30/2019. All three withdrew before randomization or starting any study procedures.|
714594|NCT03425396||
714595|NCT03425253|Participants participated in the study at 3 study sites in Australia from 02 February 2018 to 05 December 2019.|
714596|NCT03424681||
714597|NCT03424265||
714598|NCT03424044||
714599|NCT03423654||
714600|NCT03423641||This is a retrospective observational study, thus patients are not assigned and no one is excluded from the study after they become eligible.
714601|NCT03423173|Participants took part in the study at 14 investigative sites in the United States from 12 February 2018 to 14 January 2019.|Healthy participants were enrolled in 2:2:2:1 ratio into one of the four trial groups and received either Tetravalent Dengue Vaccine (TDV) lot 1, TDV Lot 2, TDV Lot 3 or Placebo for the investigation of lot to lot consistency of three consecutive lots.
714602|NCT03423082||
714603|NCT03421886||
714604|NCT03421730||Seventeen subjects were enrolled and randomized to 1 of 12 crossover treatment sequences AB, AC, AD, BA, BC, BD, CA, CB, CD, DA, DB or DC. However, data were analyzed (and presented) by individual treatment only (i.e. A, B, C and D), not per treatment sequence. Fifteen subjects received at least 1 study treatment; 13 subjects completed the trial.
714605|NCT03421379||Participants were randomized to receive either nasal glucagon or intramuscular (IM) glucagon in the first period, followed by the alternate treatment in the second period.
714606|NCT03421210||
714607|NCT03420625||
714608|NCT03420300|The study was conducted at 6 medical center in Taiwan to evaluate the tolerability and efficacy of elbasvir/grazoprevir (EBR/GZR) for patients with hepatitis C virus genotype 1 infection and receiving hemodialysis. The recruitment period was from 05 June, 2018 to 30 April, 2019|The study was an one-arm, open label, multi-center study. Patients were checked for inclusion and exclusion criteria to assess the eligibility. There was no pre-assignment criteria in the study.
714609|NCT03419962|This was an open-label observational study to measure the effectiveness of 6 weeks treatment of Spiolto® Respimat® in Patients with Chronic Obstructive Pulmonary Disease (COPD). The Clinical COPD Questionnaire (CCQ)-score was used to evaluate changes in health and functional status.|All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion and non of the exclusion criteria. 1 enrolled participant was excluded as he/she did not have at least one documented administration of Spiolto® Respimat®.
714610|NCT03419780||
714611|NCT03419598|The virtual patients were created based on CT data sets obtained for 30 patients with knee osteoarthritis. The virtual patients were duplicated, and then enrolled into both arms.|
714612|NCT03419078||
714613|NCT03418662|592 patients were enrolled in the study, but 17 were excluded before randomization for not meeting inclusion criteria. 569 patients were randomized.|
714614|NCT03418571|"Sixteen subjects were screened for Cohort 1. Of these, 15 subjects were randomized. There was 1 screen failure due to consent withdrawal.
~For Cohort 2, 1 subject was screened but considered a screen failure (consent withdrawal).
~Consent was obtained from the first subject on 1 March 2018; last subject completed the final visit on 19 October 2018"|All randomized subjects received at least 1 administration of study drug and were included in the Safety Population.
714615|NCT03418376||
714616|NCT03418324|Study opened to accrual February 5, 2018 and the first patient on study March 5, 2018. As of November 6, 2019, 12 patients have been consented, 11 were enrolled, and 11 were off-treatment and off-study. Study closed to accrual on May 1, 2019, as drug manufacturer has limited drug supply without plans to increase production.|Early accrual closure due to manufacturer's limited drug supply.
714617|NCT03418064||
714618|NCT03417830|This was a two part study. Part A contains two dosing sessions and Part B contain single dosing session. This study was conducted at a single center in Sweden from 06-April-18 to 20-July-2018.|Two participants were enrolled in Part A. The study was terminated by sponsor due to a change in the benefit:risk profile of GSK2315698+GSK2398852 (anti-serum amyloid P component [SAP] treatment) during Part A; hence, no participants were enrolled in Part B.
714619|NCT03417752||
714620|NCT03417713||
714621|NCT03417557||Three subjects did not meet the inclusion criteria. Seventeen (17) subjects completed all visits and were included in the analysis.
714622|NCT03417505||
714623|NCT03417466||A total of 72 subjects signed the informed consent form and completed the screening. Five subjects failed the screening. One subject withdrew before wearing the sensor.
714624|NCT03417219||
714625|NCT03417141||
714626|NCT03417024||
714627|NCT03416985||
714628|NCT03416127||
714629|NCT03415243|Participants were recruited from one center in USA.|A total of 32 participants were screened, of whom 28 were randomized for treatment and 4 were screen failures.
714675|NCT03400800||
714676|NCT03400787||
714630|NCT03415178|The study was conducted at 13 centers in the United States. A total of 92 participants were screened on 29-March-2018 with randomization between 05 April 2018 and 12 April 18 of whom 23 were screen failures. Screen failures were mainly due to exclusion criteria met.|Randomization to treatment arms was done centrally using treatment allocation system (Interactive Response Technology) in a 1:1 ratio (alirocumab from auto-injector device [AI] : alirocumab from new auto-injector device [SYDNEY]). A total of 69 participants were randomized.
714631|NCT03415152||
714632|NCT03415022||"9 participants discontinued the study after initial evaluation but before treatment randomization:
~5 discontinued due to scheduling difficulties
~2 discontinued due to COVID-19 research suspension
~2 discontinued due to difficulties calibrating eye tracker used for treatment sessions"
714633|NCT03414359||
714634|NCT03414047|Completers included participants who died from any cause and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.|
714635|NCT03413618||Admitted to the hospital with the suspicion for DVT: 202; DVT verified: 158; Eligible DVT: 102; Rejected to participate: 12; Randomized: 90
714636|NCT03412929||
714637|NCT03412734||
714638|NCT03412084||
714639|NCT03412019||
714640|NCT03410628||
714641|NCT03409796|Participants took part in the study at 2 investigative sites in the Unites Stated from 24 April 2018 to 02 May 2019.|Participants diagnosed with celiac disease (CeD) were enrolled in a 1:1 ratio in one of the two treatment groups: 3 gram gluten per day or 10 gram gluten per day.
714642|NCT03409731|This Post-marketing Surveillance study was conducted in patients with ischemic heart disease potentially indicated for treatment with the Absorb GT1 Bioresorbable Vascular Scaffold System. A total of 135 patients were enrolled between December 13, 2016 to December 11, 2017 time period.|The proposed target sample size of the surveillance was approximately 2,000 patients. However, only 135 patients were registered in this study since Absorb GT1 was withdrawn from global market, due to low sales volume.
714643|NCT03408730||
714644|NCT03408639||
714645|NCT03408483||
714646|NCT03408392|This was an open-label, randomized, single-dose, two-period cross-over study to evaluate bioequivalence of SKF101804 Cefixime 200 milligram (mg)/5 milliliter (mL) suspension versus Cefixime 200 mg/5 mL suspension reference product in healthy adult participants under fasting conditions. Participants were enrolled at a single center in South Africa.|Participants received treatment in one of the two sequences; SKF101804 cefixime 200mg/5mL suspension (Test formulation) followed by cefixime 200mg/5mL suspension (Reference formulation)or vice versa in each of the treatment period 1 and 2. A total number of 28 participants were randomized.
714647|NCT03408171||
714648|NCT03407625||
714649|NCT03407612||
714650|NCT03407482|The study was conducted at 50 centers in 11 countries.|160 participants were enrolled into this OLE study and were included in the ITT and Safety populations.
714651|NCT03407430|Subjects were recruited from 11/2015 through 07/2017.|Eleven subjects were screened and successfully consented to this trial. Of these, three subjects either had therapy alteration that led to their exclusion or left without study-related medication, thus 8 subjects were treated.
714652|NCT03407170||
714653|NCT03407118||
714654|NCT03406325|19 patients were recruited in the study. 12 were used for validation. 7 were used for patient-specific testing. Therefore, there were 1 validation group and 7 individuals' result.|
714655|NCT03406260||Crossover study with three study periods, each participant received single oral doses of Lasmiditan 200 milligrams (mg), Lasmiditan 100 mg and Placebo tablets as per the dosing sequence in each period. The washout period between dosing in consecutive study periods was at least 48 hours.
714656|NCT03405935|Participants were enrolled at study sites in Europe. The first participant was screened on 01 March 2018. The last study visit occurred on 29 May 2020.|90 participants were screened.
714657|NCT03405818||
714658|NCT03405259||
714659|NCT03404843||
714660|NCT03404206|The study was conducted at one center in the United States, between 12 February 2018 (first patient first visit) and 10 July 2018 (last patient last visit).|Overall, 387 participants completed surgical teeth extraction, and all of them were randomized and received the treatment.
714661|NCT03404167|The trial was performed at a commercial phase 1 unit. Recruitment opened on February 2, 2018 and all eight participants were consented and screened for meeting eligibility criteria prior to enrollment and dosing on Feb 23, 2018.|This was an open-label, non-randomized single-dose oral treatment of eligible participants followed by follow up to eight days after dosing.
714662|NCT03403712||202 patients were randomized to IV NEPA and 202 patients were randomized to Oral NEPA. Two randomized patients (Patient IDs 211003 and 213001) in the IV NEPA group did not receive any active study drug or AC chemotherapy.
714663|NCT03403504|24, from Mar2017 to Jul2017, from patient database, medical clinic, advertisement recruitment and etc.|
714664|NCT03403491||
714665|NCT03403413|3|3
714666|NCT03403400|The participants were recruited from July 2018 - September 2019 through consecutive admissions from two outpatient clinics with therapists with experience in VR.|After the subject signed the informed consent, the study coordinator was notified by the research staff to conduct a retrospective chart review of the medical record of the subject. Based on the retrospective chart review, the study coordinator determined if the subject was eligible to participate in the study.
714667|NCT03403374|Participants were enrolled at 10 study centers in India. The first participant was enrolled on 04 August 2018 and the last participant was enrolled on 29 August 2019.|
714668|NCT03403036|41 patients screened with 39 meeting all eligibility requirements. Patients with moderate-to-severe psoriasis were recruited from 3 sites.|
714669|NCT03402932||No significant event after andnrollment, prior to assignment
714670|NCT03402893||1 participant signed consent but failed screening
714671|NCT03402750||
714672|NCT03402555||The mother was to complete an eQuestionnaire for eligibility confirmation and upload 3 separate test images of her infant/toddler's stool via ClaimIt within a window of 10 days. The mother and infant/toddler were enrolled if the test images were successfully uploaded and if they met all inclusion criteria and none of the exclusion criteria.
714680|NCT03400163||"3 participants were enrolled, randomized and treated within this sub-study (PK cohort).
~Note: parent study is NCT02413372 (MB130-045)."
714681|NCT03399370||
714682|NCT03398928||
714683|NCT03398798||
714684|NCT03398421|This was a Phase I, single center, open label, one sequence cross-over study conducted in healthy males and females of non-child bearing potential to evaluate the pharmacokinetic (PK), safety and tolerability of nemiralisib administered alone and concomitantly with repeated doses of itraconazole.|A total of 20 participants were enrolled at a single center in the United States.
714685|NCT03398356||
714686|NCT03398330|42, from Mar2017 to Sep2017, from patient database, medical clinic, advertisement recruitment and etc.|
714687|NCT03398278|38, from Jun2017 to Oct2017, from patient database, medical clinic, advertisement recruitment and etc.|
714688|NCT03398213||
714689|NCT03397771||Subjects entered the 2 week Run-in Period and received subject blind placebo treatment. Subjects who continued to meet eligibility criteria at the end of the Run-in Period (at least 7 incontinence episodes per week in the diary entries), entered the Treatment Period, randomly assigned (2:1) to receive study drug (litoxetine) for placebo BID.
714690|NCT03397394|97 subjects were recruited from 40 sites across 6 countries.|
714691|NCT03397121||
714692|NCT03396913||
714693|NCT03396835||
714694|NCT03396432|The study was recruited per protocol without any protocol deviation or violation.|The block size was varying among 2, 4, 6 to avoid the predictability of device assignment. To further balance device assignment, we'll stratify the randomization by study site and clinician's role. Separate randomization schedule was generated for each stratum.
714695|NCT03395990||
714696|NCT03395886||
714697|NCT03394508||Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up
714698|NCT03394391|Participants were recruited while attending routine clinic visits across five (5) high patient-density ART sites in 2 States in South West, Nigeria over a 13 week period.|There was no significant event.
714699|NCT03393806|This was a double-blind, placebo-controlled, parallel group study conducted in participants with moderate to severe asthma with allergic fungal airway disease (AFAD). The study was conducted across 4 countries-France, Netherlands, Russian Federation and the United Kingdom.|A total of 17 participants were randomized in a ratio of 1:1 to receive either GSK3772847 10 milligrams per kilogram (mg/kg) or placebo. Recruitment in the study was terminated early due to the feasibility of completing the study in a timely manner.
714700|NCT03393754||
714701|NCT03393208||
714702|NCT03392532|Subjects were recruited from one investigative site located in the US.|This reporting group includes all enrolled subjects (36).
714703|NCT03392194|From January-March 2018, participants were recruited from two affordable housing communities. Convenience and snowball sampling methods were employed. Study staff and community partners provided information to interested participants at community events and distributed flyers and postcards throughout the communities.|Sleep hygiene (SH) group sessions served as a run-in period for randomization. Participants were consented to participate in the research study (n=38) and then attended two SH group session. At the end of the second SH session, participants were randomized to the SH-arm or the sleep hygiene and yoga (SH+Y) arm (n=33).
714704|NCT03391986||
714705|NCT03391115||Two Nurse participants in the dyadic patient-nurse enrollment were not successfully recruited.
714706|NCT03390426||
714707|NCT03390257||
714708|NCT03390166|An advertising brochure on this study which was approved by the Institutional Review Board (IRB) was distributed to potential participants. Participants who were interested in participating in this study contacted the investigator. An appointment was made to explain the details of the study individually.|"Pre-assignment Details
~A total of 945 participants who met all inclusion criteria and not of the exclusion criteria were enrolled in the study."
714709|NCT03389854||
714710|NCT03389308||
714711|NCT03388645|19 subjects were recruited; 7 were not dosed because they were either ineligible or did not start the study.|
714712|NCT03387683|Fifty three patients with type 2 diabetes and on a stable dose of metformin for at least 6 weeks were enrolled in 1 study center in Sweden and 1 center in Finland. The first patient was enrolled on 28 February 2018 and the last patient's last visit was on 19 March 2019.|Eligible patients were aged between 40 and 75 years, had type 2 diabetes for at least 6 months and had no significant coronary artery disease symptoms. Patients were randomized in a 1:1 ratio, to receive 10 milligram (mg) dapagliflozin or placebo.
714713|NCT03387462|Participants were recruited online and via social media, as well as through in-person community outreach.|
714714|NCT03387319||
714715|NCT03387059||Nine participants were enrolled and the study was prematurely terminated due to the poor feasibility and sustainability, leading to slow recruitment rate.
714716|NCT03387046||
714717|NCT03386994|Non-interventional multicenter study in Spain, based on newly collected data of patients with Idiopathic Pulmonary Fibrosis (IPF) aims to estimate the economic and social Impact of IPF according to the Forced Vital Capacity (FVC) value.|All patients who are diagnosed with IPF and attended to a routine visit during the inclusion period and met all of the inclusion and none of the exclusion criteria and provided informed consent to participate were included in the study. IPF-Patients were reported by subgroup (predicted FVC% at baseline) for baseline characteristics and outcome measures, to make comparisons between groups. Data on caregiver burden was collected from routine clinical care using medical records and patient´s diary.
714718|NCT03386474|150 subjects who completed the 96 week CORE trial (RTH258-C001) were eligible to continue in the extension. 62 CORE sub. were treated w/ brolucizumab 3mg & 45 CORE sub. w/ brolucizumab 6mg. These 107 sub. were treated in the extension w/ new formulation 6 mg brolucizumab. 43 subjects treated with aflibercept 2 mg in the CORE continued aflibercept.|
714719|NCT03386448||
714720|NCT03386435|For the donor group, adult (aged 18-60 years) liver donors scheduled for elective donor right hepatectomy from August 2016 to July 2017 at Asan Medical Center in Seoul, Korea, were screened for eligibility.|
714721|NCT03386032||
714727|NCT03383783||1 participant signed the informed consent and attended up to visit 2, but were dropped from the study as they no longer met inclusion criteria, and this occurred before randomization to interventions.
714728|NCT03383757||
714729|NCT03383627||
714730|NCT03383614||24 healthy subjects were randomized and received study drug or matching placebo.
714731|NCT03383588||
714732|NCT03383523|Potential volunteers contacted HMR by telephone or email if they were interested in the study. HMR contacted eligible volunteers who had registered an interest in doing this study to invite them to take part. Recruitment of participants started on 26 October 2017 (FSFV) and finished on 26 March 2018 (LSLV).|screening details: to check they were healthy and eligible for the study, volunteers had a full examination at screening including physical and neurological examination, vital signs, 12-lead ECG monitoring, safety blood tests (hematology, biochemistry, coagulation and urinalysis), drug screen, alcohol breath test and serology
714733|NCT03383198||
714734|NCT03382912||Completer's included participants who had progression free survival events (Progressive Disease (PD) or death).
714735|NCT03382834||
714736|NCT03382665||
714737|NCT03382262|The recruitment period for this study was from December 2017 to July 2018. The patients were enrolled at medical clinics.|
714738|NCT03381989|31 participants enrolled on protocol. 30 started the protocol, after 1 participant withdrew consent prior to the procedure.|
714739|NCT03381742|3,737 CAD patients who received either clopidogrel or ticagrelor therapy and underwent TEG test from 11 medical centers. Among these patients, 1,725 subjects were treated with clopidogrel and 2,012 subjects were treated with different ticagrelor regimens.|
714740|NCT03381248||
714741|NCT03380845||
714742|NCT03380780||
714743|NCT03380572||
714744|NCT03380429|This was an open-label, randomized, multi-center, parallel group study to evaluate the effect of the connected inhaler system (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic participants (Par) with poor control.|A total of 528 participants were screened and 437 participants were enrolled and randomized in this study.
714745|NCT03380390||
714746|NCT03379740||
714747|NCT03379545||
714748|NCT03379506|Male and female participants 3 to <18 years of age with chronic hepatitis C virus (HCV) genotype 1 (GT1) or GT4 were enrolled at 14 global study sites.|The present results include data up through the sustained virologic response 12 weeks after completing therapy (SVR12) endpoint cutoff date of 10 April 2020, and will be updated once the final dataset has been analyzed.
714749|NCT03379376||
714750|NCT03379233|This study was conducted at Netherlands and Germany between 11 July 2018 (first participant first visit) and 22 January 2019 (last participant last visit).|A total of 7 subjects were randomized in the study.
714751|NCT03378973||
714752|NCT03378076||
714753|NCT03377244||
714754|NCT03376516||
714755|NCT03376295|Primary objective was to assess the effectiveness of maintenance treatment of ChronicObstructivePulmonaryDisease (COPD) with combination of Long-acting beta2-agonist(LABA) and the long-acting muscarinic antagonists(LAMA)tiotropium(TIO) compared with the combination of a LABA and an Inhaled corticosteroids(ICS) on the time to COPD exacerbation.|Population-based propensity score-matched incident new-user cohort study.
714756|NCT03376256||
714757|NCT03376061|Between December 2017 and April 2018 a total of 97 patients were randomized to the topical (n = 49) and intravenous (n = 48) groups.|
714758|NCT03375294||
714759|NCT03374995||
714760|NCT03374488|This study was conducted at 82 centers in 16 countries.|
714761|NCT03374189|Eligible patients recruited between July 2017 and June 2018 at St. Vincent's Hospital.|
714762|NCT03374176|The study was carried out on patients at the Integral Dentistry Clinics of the University Center of Health Sciences of the University of Guadalajara in Jalisco, Mexico. The participants attended for dental care from August 2015 to December 2016.|A radiographic examination was undertaken using either periapical films or a pantomogram. Periodontal therapy was initiated within 1month of the baseline screening examination.
714763|NCT03373890|Participants were recruited through a directed mailing to children with cerebral palsy receiving care at Seattle Children's Hospital between Sept 1, 2014 and June 30 2015.|In eligible if unable to walk at greater than their self selected walking speeds with orthotics on a treadmill.
714764|NCT03373591||
714765|NCT03373162||
714766|NCT03373006||
714767|NCT03372928||This was a cross-over design study. 19 volunteers completed both the standard and high EAA testing phases.
714768|NCT03372603|Study was conducted at 4 centers in the United Kingdom. Participants who met eligibility criteria entered a 2-period crossover study. Participants were randomized to either placebo or GSK2798745 in each Treatment Period (each 7 days, with a 14-21 day washout). Total duration of participation was 10.5 weeks. Study terminated on grounds of futility|A total of 34 participants were screened of which 17 failed screening and 17 participants were included in the study.
714769|NCT03372551||Three (3) subjects did not meet inclusion criteria and were excluded from the analysis. One subject was enrolled and later discontinued.
714770|NCT03372382|recruitment start date: 12/2017 recruitment end date: 03/2018|
714771|NCT03372369|Participants were enrolled between January 26 and February 13, 2018. They were enrolled and participated in the study through a survey distributed on Amazon Mechanical Turk.|
714772|NCT03372083|The study was conducted in 10 sites in 7 countries (one in Egypt, three in Italy, one in Lebanon, one in Oman, two in Thailand, one in the United Arab Emirates, and one in the United Kingdom).|
714773|NCT03371459||Subjects who met all screening and randomization requirements were eligible for rand to Tx Period, comprised of Visits 2 and 3 . Eligible subj were rand via IWRS to receive 2 cumulative-dose Tx's in one of 2 possible Tx sequences: AS MDI, given as 1+1+2+4+8 actuations of AS MDI 90 μg, Proventil, given as 1+1+2+4+8 actuations of Proventil 90 μg
714774|NCT03371381||The trial consisted of two parts (Phase 1 b and Phase 2). However, Phase 2 was not conducted due to early termination of the study. All analyses were performed on Phase 1b data.
719393|NCT02649634||
719394|NCT02649608||Groups are overlapping the cohorts
714775|NCT03370770|Non-interventional, multi-centre cohort study based on existing data from medical records of patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC) treated with afatinib (Gi[l]otrif®) as first-line treatment followed by osimertinib in case the T790M resistance mutation was developed. The study included an extension analysis using additional collected data of the enrolled patients.|All patients were screened for eligibility to participate in the trial. Only patients that met all the inclusion and none of the exclusion criteria were included in the trial.
714776|NCT03370536||
714777|NCT03370419||
714778|NCT03370302|Participants took part in the study at 4 investigative sites in Japan, South Korea and Taiwan from 17 January 2018 to 28 August 2019.|Participants with advanced nonhematological malignancies were enrolled in Dose Escalation and Expansion Phase to receive TAK-228 in 1 of the 2 schedules: once daily (QD) or once weekly (QW). Further enrollment in QW schedule was stopped and study was terminated before QW expansion because more favorable safety profile were observed in QD schedule.
714779|NCT03370289|Participants took part in the study at one investigative site in Japan, from 12 January 2018 to 28 February 2018.|Healthy volunteer were enrolled and vaccinated the study drug, BLB-750 at a 3-week interval (Day 1 and Day 22) in a treatment period of 43 days through intramuscular route.
714780|NCT03370042||
714781|NCT03369951|Participants were recruited from those presenting at the ICU critically-ill with illness known or suspected to be caused by infection with Gram-negative bacteria. Enrollment occurred between 28MAR2018 and 18JUL2019.|
714782|NCT03369756||
714783|NCT03369704|This study was conducted at 22 centers in Kanto-area of Japan.|337 patients were randomized
714784|NCT03369418|Subjects were recruited by flyers from the WLA VA Integrative Medicine Clinics and on the UCLA campus between April 2016 and August 2018.|
714785|NCT03369340|40 subjects were screened for eligibility. 21 subjects were screen failures (10 reserve subjects were not enrolled, 9 subjects did not meet eligibility criteria, and 2 subjects withdrew.)|"On Day 1, 19 subjects were enrolled and exposed to P3P 3 before randomization.
~One enrolled subject withdrew after P3P 3 use before randomization. 18 subjects were randomized."
714786|NCT03369197|Patients were recruited in the Endoscopy suite at Johns Hopkins Hospital.|
714787|NCT03369158||
714788|NCT03368937||
714789|NCT03368898||
714790|NCT03368807||
714791|NCT03368235|This was a Phase 2a study conducted in participants with active rheumatoid arthritis (RA) in spite of stable treatment with conventional disease-modifying anti-rheumatic drugs at 5 investigational sites across Sweden and The Netherlands between 18 January 2018 and 12 November 2019.|A total of 21 participants were randomized in a 1:1 ratio to take either AZD9567 or prednisolone in a 2-week double-blind, double-dummy treatment period.
714792|NCT03368170|The study was conducted as an outpatient trial and patients were identified from 20 sites across two countries. The first patient was enrolled 13 April 2018 and the last past completed 12 June 2019.|Patients completed two 24-hour diaries during run-in of which one had to be valid prior randomization.
714793|NCT03368053|This study was conducted at one Centre in Belgium.|A total of 36 subjects were enrolled in the study. Those subjects received at least three doses of the GSKSB732461 vaccine candidate in GSK-sponsored 732461/002 (PRO HIV-002) study.
714794|NCT03366207||
714795|NCT03365934||
714796|NCT03365778||
714797|NCT03365011||
714798|NCT03364608|This study was conducted at 10 sites in the United States, from December 2017 to March 2018. The study was anticipated to run for at least 23 days but not to exceed 68 days.|Subjects were randomized into one of 10 treatment sequences. Each sequence comprised all 5 treatments included in this study (ie, AS MDI 90 μg, AS MDI 180 μg, Placebo MDI, Proventil 90 μg, and Proventil 180 μg) in a randomized order
714799|NCT03364335|Subjects meeting all inclusion criteria and no exclusion criteria were randomized to one of five treatment arms in the ratio of 1:1:1:1:1(A:B:C:D:E). The randomization was stratified by a maximum of 70% female with a BMI range between 30 kg/m2 and 45 kg/m2|The discrepancy in the number of enrolled subjects and the actual number that started the study is because some of the enrolled subjects did not start the study for the following reasons: they moved, were not compliant with investigator request or were sent on active military duty.
714800|NCT03364192||
714801|NCT03364023||
714802|NCT03363906||Participants were randomly assigned into different treatment sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2. Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.
714803|NCT03363776||10 participants randomized and treated
714804|NCT03363633||The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).
714805|NCT03362944||No participants were excluded from the study prior to assignment to groups.
714806|NCT03362879|In total, 412 participants were enrolled in the study and 409 of these participants fulfilled all inclusion and none of the exclusion criteria and, thus, were included in the full analysis set.|
714807|NCT03361917||
714808|NCT03361865|This study was conducted at 98 centers in 17 countries.|
714809|NCT03361605||
714810|NCT03361228|The study was conducted at 3 different sites in US. A total of 10 patients were screened and 5 patients enrolled in study.|No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
714811|NCT03361176||
714812|NCT03360903||
714813|NCT03360344||Forty-four (44) participants and sixty-eight (68) wrists were enrolled in the study. Some participants had bilateral involvement whereas other participants only had one wrist that was involved.
714814|NCT03360110||
714815|NCT03360071||
714889|NCT03342469|Participants with ADHD and neuro-typical controls were recruited from Jan. 2018 until Oct. 2018 at a Mid-Atlantic University.|"Two-week AFC-free diet to standardize intake before randomization to challenge with AFC relative to placebo.
~Washout period of 4 days between challenge with AFC and placebo."
719750|NCT02612727||
714816|NCT03359850|This study evaluated pharmacokinetics and safety of niraparib in participants with advanced solid tumors and with either normal hepatic function or moderate hepatic impairment. The results presented are based on primary analysis up to 18 months. Data collection is still on-going and additional results will be provided after study completion.|This is a 2 period study including pharmacokinetic (PK) phase and extension (Ext.) phase. A total of 17 participants were enrolled in the study and received study treatment, niraparib.
714817|NCT03359629||
714818|NCT03359473|This was a Phase II, double-blind, randomized, multicenter study to evaluate the safety and efficacy of GSK2881078 over 13 weeks of once daily oral dosing, first time administered in older men and post-menopausal female participants with chronic obstructive pulmonary disease (COPD) and muscle weakness, participating in home exercise.|A total of 200 participants were screened and 97 participants were enrolled in this study. Of which, 96 participants were randomized and received the study treatment. The remaining 1 participant was randomized without fulfilling the inclusion and exclusion criteria and therefore did not receive study medication.
714819|NCT03358576||
714820|NCT03358472||This study was conducted at 76 centers in 14 countries.
714821|NCT03358407|This was a 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2983559 in healthy participants. The study was terminated early due to non-clinical toxicology findings and reduced safety margins. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.|A total of 85 participants were screened, of them, 54 participants were screen failures and 31 participants were enrolled and received study treatment in Part A. The study was terminated during Cohort 2 of Part A, hence no participants were enrolled in period 3, 4 and 5 (Cohort 2) of Part A and in Part B.
714822|NCT03358355||
714823|NCT03358329|Patients were recruited at 10 sites across the US between November 2017 and January 2018.|
714824|NCT03358251||
714825|NCT03358238||Two participants were enrolled and subsequently excluded before the start of the study. One of these individuals died between the consent date and the start of the study, and the other was lost to follow-up between the consent date and study start.
714826|NCT03358147|The study randomized subjects at 194 sites in the United States from December 2017 to September 2019. The entire study period was scheduled to take up to approximately 26 weeks for each individual subject from the time of screening through the follow up period.|Subjects were randomized in a 2:2:2:2:1 Scheme to follow 1 of the 5 treatment groups.
714827|NCT03357952||A total of 10 participants were enrolled in the study. Among these, 9 participants were included in the Safety Run-in phase (Part 1) who received daratumumab intravenous (IV) and JNJ-63723283 IV and 1 participant randomized to Arm A in Part 2 of the study who received daratumumab IV alone.
714828|NCT03357731||"49 participants assigned to treatment and 45 treated. Reasons not treated: 2 re-randomized; 1 randomized in error, screen failure; 1 no longer met study criteria.
~Note: Study designed for all participants to enter all 3 arms (reassignment of arms occurs every period change)."
714829|NCT03357614||
714830|NCT03357471|The study started to enroll patients in November 2017 and concluded in July 2018.|Participant Flow refers to the Safety Set (SS), which consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device).
714831|NCT03357341|This was a prospective observational study that included two cohorts of participants identified through electronic health records (EHR) within the Geisinger Health System (GHS) database. The study was conducted at a single center in the United States.|A total of 194 participants were enrolled and followed up for six months. The study data was captured remotely via sensors and devices provided by GlaxoSmithKline (GSK) to the participants, or via extraction of EHR data.
714832|NCT03356977||
714833|NCT03355820|This study was conducted at a single center in China.|228 subjects were included in the Enrolled Set, 1 subject was excluded from all statistical analyses, thus 227 subjects formed the Exposed Set.
714834|NCT03354754|Approximately 60 patients were planned to be randomized to LYS228 or a comparator (standard of care therapy preferably piperacillin/tazobactam) in a 2:1 ratio.|
714835|NCT03354663||
714836|NCT03354637||
714837|NCT03354598||
714838|NCT03354429|414 study sites in 28 countries enrolled patients. The first patient was enrolled on 22 January 2018. The last patient visit took place on 13 December 2019.|11073 patients screened; 11016 patients randomised. 57 patients who were not randomised (patient did not meet inclusion/exclusion criteria n=52, patient decision n=5).
714839|NCT03354325||
714840|NCT03353922||Randomized 3-way cross-over of multiple doses of 150 mg tolperisone, 10 mg cyclobenzaprine, or placebo TID in 35 male & female healthy volunteers. Treatment groups A (Tolperisone), B (Cyclobenzaprine), and C (Placebo) randomized by 6 treatment sequences. Subjects serve as own positive control, data analyzed and reported based on treatment type.
714841|NCT03353246||
714842|NCT03352882||
714843|NCT03352713||
714844|NCT03352609||
714845|NCT03352453||
714846|NCT03351933||A total of 146 subjects were screened for the study, and 8 of them were rescreened. The screen failures were mainly due to body mass index out-of-range. A total of 28 subjects were enrolled in the study.
714847|NCT03351738|The study was conducted in the US between 13Dec2017 and 09Nov2018.|A total of 248 participants consented to participate in the study, of which 115 were screen failures. A total of 133 participants were randomized to the study of which only 132 received treatment. One participant was ineligible, being randomized by error but not followed or treated.
714848|NCT03351699||
714849|NCT03351335|The study was conducted at 7 investigational sites in the United States.|A total of 180 participants were screened, out of which 60 were enrolled and treated. Of these, 56 participants completed the study.
714850|NCT03351231||7 participants were enrolled and 5 of those participants entered treatment; reasons for 2 participants not entering treatment were due to: 1 death; 1 participant no longer met study criteria. Note: study terminated following starting dose of BMS-986242 12.5 mg; dosing did not escalate.
714851|NCT03351101|There were 271 participants enrolled, with 136 Senofilcon C participants dispensed lenses and 132 Samfilcon A participants dispensed lenses (268 participants total).|
719751|NCT02612688||
721740|NCT02428192||
721741|NCT02427984||
714852|NCT03350984|A total of 111 hospitalized DM2 patients not critical to the study were evaluated. Of these, 35 did not meet the inclusion criteria and the 75 included participants were randomized into two groups. The recruitment of patients began on November 2, 2017 and ended on June 1, 2018.|"Within the physiological group, 1 patient was eliminated before initiating the insulin regimen, presenting acute abdomen and requiring intensive therapy. Therefore, 36 patients will start treatment in the physiological group and 39 patients in the traditional group."
714853|NCT03350919||No subjects were excluded from the study between recruitment and randomization to assigned groups.
714854|NCT03350724||
714855|NCT03350503|Of the 125 subjects enrolled, 4 were exited as screen failures. This reporting group includes all subjects with successful test article implantation unilaterally (121 subjects).|
714856|NCT03350256||
714857|NCT03350217||
714858|NCT03349632|Subjects were recruited from 3 investigational sites located in the United States.|Of the 68 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (66).
714859|NCT03349515||
714860|NCT03349437||
714861|NCT03349333||In the protocol, 85 patients are planned to enroll. However, 71 patients are treated in the real situation.
714862|NCT03349099|Recruitment was conducted from urology pre-operative clinic from July 1 2014 to May 31 2016|No patients were excluded prior to assignment.
714863|NCT03349060|Participants with age greater than or equal to (>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of >=40 kilogram were enrolled in the study. Eligible participants had an option to enter into a long-term extension (LTE) study after completing 12 weeks of treatment in this study.|This study was conducted from 07-December-2017 to 26-March-2019 at 76 sites in 8 countries.
714864|NCT03349034|Participants undergoing osseocutaneous fibula or scapular tip free flaps for head and neck reconstructionwere enrolled from September 2017 and September 2019.|
714865|NCT03348904|Approximately 630 participants were planned to be randomized. Prior to the termination of the study, 2 participants were randomized to the Platinum Doublet Chemotherapy arm (Arm B) and treated.|
714866|NCT03348683|First enrollment 12-11-2017, final enrollment 12/11/2018. Enrollment occurred on the labor floor of the Mount Sinai Hospital.|
714867|NCT03346902||
714868|NCT03346850||
714869|NCT03346759||
714870|NCT03346161|The study was opened to participant enrollment on 01/12/2018 and closed to participant enrollment on 10/24/2018.|
714871|NCT03346070||
714872|NCT03346057||Of 344 participants randomized to the study, 331 received at least one dose of study treatment (All Treated Population) and were evaluable for all safety analysis.
714873|NCT03345979||Of the 200 patients enrolled and randomized to treatment, there were 195 patients included in the full analysis set. These were patients who randomized, received 1 dose study drug and had at least one post-baseline Positive and Negative Syndrome Scale (PANSS) assessment.
714874|NCT03345914|"A total of 474 participants were screened for study eligibility at multiple sites in the United States and Europe. Screen failure was mostly due to inclusion/exclusion criteria not met and other reasons. The majority of participants (221/367) were enrolled at study sites in the United States."|A total of 474 participants were screened. 367 participants randomized in 1:1:1 ratio to 1 of 3 treatment groups. 5 randomized participants were not treated (2 in placebo + TCS group & 3 in combined dupilumab + TCS group). Participants randomized to receive Dupilumab 100 mg or 200 mg Q2W + TCS, Dupilumab 300 mg Q4W + TCS or matching placebo.
714875|NCT03345901||
714876|NCT03345472||175 subjects were enrolled. 32 exited before the spinal cord stimulation trial. 143 subjects started the trial and 12 exited during the trial. 131 subjects completed the trial: 117 had a successful high dose (HD) trial; the 14 with unsuccessful HD trial were exited. Of the 117, 14 exited before implant and 103 were implanted (Treated Arm).
714877|NCT03345407|This was a Phase IIb, multicenter, randomized, stratified, double-blind (sponsor open), placebo controlled parallel-group study in participants who presented with an acute moderate or severe exacerbation of chronic obstructive pulmonary disease (COPD) requiring Standard of Care (SoC).|A total of 943 participants were randomized, and 938 participants who received at least one dose of study treatment were included in the modified intent to treat (MITT) Population. The study included participants enrolled from 16 countries.
714878|NCT03345108|All the participants were recruited from one center in United States.|A total of 49 participants were screened for entry into the study, of whom 48 were randomized. 1 participant did not meet the study criteria. Out of 48, only 47 subjects started the no adhesive treatment period, since 1 participant discontinued the study due a scheduling (withdrawal of consent).
714879|NCT03344861||
714880|NCT03344640|Of all patients randomized (N= 98; 100%) in the study, a total of 96 patients (98%) were dosed (49 patients in the secukinumab 300 mg group and 47 patients in the placebo group)|2 patients were not dosed, one patient decided to discontinue on Day 1 due to a common cold and one patient was a run-in failure
714881|NCT03344562||
714882|NCT03344510|Healthy volunteers were recruited from the area surrounding the University of Pennsylvania using IRB-approved flyers, as well as approved email communications, and postings on an approved website|This was a split body study, so each participant functioned in both intervention and control arms.
714883|NCT03344172||
714884|NCT03343639||
714885|NCT03343080||
714886|NCT03343067||The study was terminated early for business reasons, not for safety concerns. There are no subject data past Treatment Month 6.
714887|NCT03342898|Participants took part in the study at 11 investigative sites in the United States from 28 Feb 2018 to 22 May 2019.|Healthy participants were enrolled in 1:1:1 ratio in 3 parallel groups. Participants received concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in Groups 1, 2 and 3.
714888|NCT03342560|All 30 patients were scanned in clinic ultrasound setting. 2 visits were scheduled for each patient. Mean difference between visits was 11 days. Mean difference between liver biopsy date and first visit date was 89 days. 2 patients were lost to followup for 2nd visit.|
714890|NCT03342157|Recruitment occurred from 11/01/2017 through 05/11/2020 at St Lukes Medical Center utilizing outpatient and inpatient referrals from practitioners.|No enrolled participants were excluded from the study.
714891|NCT03341923|Subjects were recruited from 4 study sites located in Japan.|Of the 151 enrolled, 17 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
714892|NCT03341910||
714893|NCT03341728||
714894|NCT03341637|Participants took part in the study at 5 investigative sites in Mexico from 14-Dec-2017 to 26-Jan-2019.|Healthy volunteers were enrolled in a 3:1 ratio into 2 parallel study groups: 1 study group received 2 doses of Tetravalent Dengue vaccine (TDV) and another group received 2 doses of TDV matching placebo subcutaneously (SC).
714895|NCT03341546||
714896|NCT03341533||
714897|NCT03341312||
714898|NCT03341299||
714899|NCT03340961||
714900|NCT03340883|Subject enrollment was stopped prematurely due to the sponsor's decision to terminate the study. Therefore, the study did not proceed to the Phase 2 portion of the study protocol. All reporting groups are for Phase 1 only.|
714901|NCT03340805||
714902|NCT03340610||
714903|NCT03340350||
714904|NCT03339726||
714905|NCT03339583||The decision to recruit more patients than it was stated in protocol was made because of dropout of 3 patients and in order to get enough experimental data to provide statistical power
714906|NCT03339453||"In each period, either 3 milligram (mg) nasal glucagon (NG) or 1 mg intramuscular (IM) Glucagon was administered.
~After a wash-out period of at least 1 day (24 hours) from the first period (first visit), participants crossed over to the alternate glucagon treatment in period 2 (second visit)."
714907|NCT03339206|Participants were recruited and screened for study eligiblity online between June 2017 and April 2018, and invited to enroll after the study started and they were determined to be eligible.|845 participants consented to participate in the study, of those 41 did not complete the baseline questionnaire and were not randomized. Of the 804 originally reported 12 were ineligible since they were not current smokers, 1 person withdrew, and 2 were duplicates. Our final analytic sample is 789.
714908|NCT03338816|Participants with acute hepatic porphyrias (AHP) were enrolled at thirty-six sites in Australia, Bulgaria, Canada, Germany, Denmark, Spain, Finland, France, United Kingdom, Italy, Japan, Korea (the Republic of), Mexico, Netherlands, Poland, Sweden, Taiwan and the United States.|
714909|NCT03338803|Non-interventional, retrospective cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data for the period of 01 July 2011 through 31 March 2017.|Type 2 diabetes mellitus (T2DM) patients with written prescription for initiating Linagliptin (Tradjenta®, Jentadueto®, or Jentadueto XR®) were identified during identification period starting on 01 January 2012 and ending on 30 September 2016. Aim was to describe real world glycemic-lowering effectiveness across range of ages and renal function.
714910|NCT03338673||
714911|NCT03338556||
714912|NCT03338400||
714913|NCT03338036||
714914|NCT03337490||
714915|NCT03337477|Participants took part in the study in the United States, Russia, Denmark and Italy from 13 February 2018 to 21 December 2018.|Patients with S-K ≥5.8 mmol/L for whom treatment with insulin and glucose to manage hyperkalaemia has been determined medically appropriate by the Investigator. The study originally recruited patients with S-K ≥6.0 mmol/L; however, this inclusion criterion was updated during CSP Amendment to allow enrolment of patients with S-K ≥5.8 mmol/L.
714916|NCT03337308||Data are presented for the Full Analysis Set, comprised of all randomized participants. One participant was randomized but was not treated.
714917|NCT03336853||
714918|NCT03336645|The study was conducted at 28 study centers in the Japan between 23 October 2017 (first participant first visit) and 19 August 2019 (last participant last visit).|A total of 25 participants were enrolled, received treatment and completed the study.
714919|NCT03336502|70 participants were randomized and 70 received at least one dose of study drug.|
714920|NCT03335800|Participants downloaded the app; those with irregular pulse notification had a first teleconference visit with telehealth provider; an ECG patch was shipped to eligible participants to wear for 7 days, then they returned the patch for analysis and had a second teleconference visit to review the findings with the telehealth provider.|
714921|NCT03335566|The study was conducted at 17 centres in China, Korea and Taiwan. A total of 424 participants were enrolled between 11 May 2014 and 9 April 2015.|Participants were randomised in 1:1 ratio to receive either Sonazoid™ or SonoVue®.
714922|NCT03335254|The trial enrolled nine male subjects. All subjects received treatment and completed the study. None of the enrolled/randomized subjects were withdrawn or discontinued from the study.|
714923|NCT03335150||
714924|NCT03334825|The study team recruited participants onsite at 22 HIV emergency single adult shelters across NYC between April 2012 and April 2013|
714925|NCT03334812|All patients were recruited from 3 clinical sites in Austria.|The original set up of this trial was for 2 cohorts of LNA043 (20 mg and 40 mg). The trial was terminated before any patient in the LNA043 40 mg cohort was randomized
714926|NCT03334747|This study was conducted in 10 centers in 5 countries: Mali (2), Uganda (3), Ghana (2), Gabon (1), Rwanda (2).|Approximately, 210 patients were planned to be randomized in six cohorts (KAE609: 150 and Coartem: 60). A total of 188 (KAE609: 137 and Coartem: 51) subjects were randomized in five cohorts. Cohort 6 was optional and never initiated. Two of the 188 randomized subjects were not treated and therefore were excluded from all analyses.
714927|NCT03334734||
714928|NCT03334721||
714929|NCT03334630|Enrollment/randomization occurred between 06NOV2017 and 26OCT2018 across 23 sites in the US, Canada and Europe.|
714930|NCT03334448||
714931|NCT03334422|Participants who completed double blind treatment phase had option to enter extension study I4V-MC-JAHN (NCT03334435).|
714932|NCT03334396|Participants who completed double blind treatment phase had option to enter extension study I4V-MC-JAHN (NCT03334435).|
714933|NCT03334214|44 participants were randomized at multiple study centers in Canada, Hungary, and Poland.|A total of 173 participants were screened for the study and 44 participants were randomized and received study drug.
714934|NCT03334175||
714975|NCT03323723||
714976|NCT03323307||
714977|NCT03323164||
725554|NCT02110277||
725555|NCT02110264||
714935|NCT03333876|58 participants at one site were consented in October 2017 in Pittsburgh, Pennsylvania. 29 were snorers, 29 were bed partners.|Of the 29 couples, 2 participants screened out. Therefore 27 participants started the study.
714936|NCT03333746||
714937|NCT03333577||
714938|NCT03333317|On 17 October 2018, the study was stopped prematurely by the sponsor as a precautionary measure, to allow further evaluation and assessment of the new nonclinical pharmacokinetics (PK) and safety findings and determine their relevance to human studies.|Total 7 participants were randomized to receive lumicitabine or placebo.
714939|NCT03332979|11/01/2018-31/01/2019 Carers were recruited via a number of avenues including; 9 NHS hospital trusts across England who acted as Participant Identification Centres, the Join Dementia Research (JDR) website and through Alzheimer's Society avenues such as the Alzheimer's Society research network and the Care and Cure magazine.|
714940|NCT03332784|Participants took part in the study at 3 investigative sites in Japan from 04 November 2017 to 04 September 2018.|Healthy adult and elderly participants were enrolled to receive TAK-925 or placebo in Cohorts 1 and 2 under alternating panel design and in Cohorts S1, S2, 3, and 4 under parallel design of Part 1, and participants with type 1 narcolepsy were enrolled to receive TAK-925 or placebo in a 2-period cross-over design in Cohorts 5, 6, and 7 of Part 2.
714941|NCT03332160||
714942|NCT03331965||
714943|NCT03331835||
714944|NCT03331315||
714945|NCT03331185||
714946|NCT03331042||
714947|NCT03330834||
714948|NCT03330457|healthy subjects|18 subjects met the inclusion/exclusion criteria; 18 subjects were randomized to two cohorts (6 andexanet and 3 placebo each cohort)
714949|NCT03330275|A total of 24 subjects were enrolled into this study. All enrolled subjects met all eligibility criteria and were dispensed a study lens. Of the dispensed subjects, all 24 completed the study.|A 2X2 William's crossover design was utilized for visit 1. A 3X3 William's Crossover design was utilized for visits 2, 3 and 4.
714950|NCT03330236|Among the 70,783 patients scheduled to undergo an elective surgical procedure in the main operating rooms at Xiangya Hospital from October 2017 to August 2019, a total of 1,560 participated in this study.|
714951|NCT03330041|This randomized clinical trial was conducted at the University of California, Davis dermatology clinic from November 28, 2017, to June 15, 2018.|
714952|NCT03329989||
714953|NCT03329885||96 participants were enrolled (screened) of whom 36 were screen failures, 22 were approved but not dosed and 38 were randomized in the study.
714954|NCT03329690|In the Primary Cohort, a total of 188 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to treatment. In the Exploratory Cohorts, a total of 43 non-randomized participants were enrolled and received treatment. Study participants for all cohorts were enrolled at clinic sites in South Korea and Japan.|In the Primary Cohort, participants with HER2 overexpressing gastric of GEJ adenocarcinoma were randomized (2:1) to either DS-8201a or physician's choice (irinotecan or paclitaxel). In the Exploratory Cohorts, participants with HER2 IHC 2+/ISH negative advanced gastric or GEJ adenocarcinoma who were naïve to HER2 treatment received DS-8201a.
714955|NCT03329573|This was a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of Paroxetine immediate release (IR) tablets manufactured in GlaxoSmithKline Tianjin (GSKT) (A) and Mississauga (B) sites in healthy Chinese participants under fasting and fed conditions.|Participants received treatment in one of the two sequences; treatment A (GSKT, Paroxetine IR investigational drug) followed by treatment B (Mississauga, Paroxetine IR reference drug) or vice versa in each of the treatment period 1 and 2. A total of 85 (47 under fed condition and 38 under fasting condition) participants were enrolled.
714956|NCT03329209|Participants took part in the study at 1 investigative site in China from 05 March 2018 to 05 September 2018.|Healthy Chinese participants were enrolled to receive a single dose of vedolizumab intravenous 300 milligram (mg).
714957|NCT03328949|Study recruitment and enrollment took place at 15 clinical sites in 9 European countries between May 2018 and March 2019. A total of 120 subjects with calcified, stenotic de novo coronary arteries were enrolled and treated with the Coronary Intravascular Lithotripsy (IVL) System.|
714958|NCT03328897|Patients were recruited from 27 sites across China.|Patients were randomized into three treatment groups (omalizumab 300 mg s.c., omalizumab 150 mg s.c. and placebo) in a 2:2:1 ratio.
714959|NCT03328624||
714960|NCT03328208||
714961|NCT03328182||
714962|NCT03327402|The study was conducted at eight centers in the United States between 13 March 2018 (first participant first visit) and 05 October 2018 (last participant last visit).|A total of 24 participants were enrolled and received the treatment. Of them 12 participants were included in the rich pharmacokinetic (PK) sampling group and 12 participants were included in the sparse PK sampling group. Overall, 22 participants completed the study.
714963|NCT03327051|Participants attended an initial study visit at week -2, followed by a baseline visit at week 0, and a final visit at week 4.|
714964|NCT03326999|Recruitment began in October with enrollment from December 2017 through December 2018.|
714965|NCT03326986||Participants in Panels A and B received a single-rising dose of MK-7252 or placebo in 5 alternating dosing periods. Participants in Panel C received a single-rising dose of MK-7252 or placebo in 3/5 planned periods (P). A 180 mg dose was added (P3). P4-5 were not run so the 240, 360, 540, and 120 mg fed and placebo fed doses were not given.
714966|NCT03326869||
714967|NCT03326843||
714968|NCT03326518||
714969|NCT03326323||
714970|NCT03325894|The study was conducted at 33 centers in the United States between 02 January 2018 (first participant first visit) and 19 January 2019 (last participant last visit).|Overall, 141 participants enrolled and received the treatment in two groups (Group A and B). Participants who completed antecedent studies SHP465-112 (NCT03327402) or SHP465-309 (NCT03325881) were in Group A and participants who were directly enrolled into this study were in Group B.
714971|NCT03325881|The study was conducted at 43 study centers in the United States between 09 December 2017 (first participant first visit) and 07 June 2018 (last participant last visit).|A total of 124 participants were screened, of them 89 were randomized and 88 received the treatment. Out of them, 83 participants completed the study.
714972|NCT03325673||
714973|NCT03324451||
714974|NCT03323736||
714978|NCT03323086||50 women enrolled in the trial. Two women who enrolled withdrew prior to randomization. Thus, 48 women were randomized.
714979|NCT03322930|patients recruited from medical clinic (Texas Retina Associates)|
714980|NCT03322566|Participants took part in the study at 65 investigative sites in 14 countries from 09 January 2018 to 13 December 2018.|
714981|NCT03322540|A total of 154 participants were randomized in 1:1 to either combination (Pembrolizumab+Epacadostat) and control (Pembrolizumab+Placebo) groups. As of Amendment 05, study design was changed to unblinded, open-label, and single-arm (epacadostat and placebo were removed). All participants remaining in the study will receive pembrolizumab monotherapy.|
714982|NCT03322514||
714983|NCT03322462|Enrollment occurred between Nov 2017 and Aug 2018. Recruited subjects with clinically diagnosed early AD who were interested in participating in AD therapeutic clinical trial AACG (Eli Lilly and Company; TRAILBLAZER-ALZ; NCT03367403)|
714984|NCT03322423|A total of 78 subjects were enrolled into this study. Of the enrolled all 78 were dispensed at least one study lens. Of the dispensed subjects 71 completed the study, while 7 subjects were discontinued.|
714985|NCT03322293||
714986|NCT03321721||
714987|NCT03321396|The recruitment started in January 2017. The location was taken place at National Cheng Kung University Hospital. Patients who met the inclusion criteria were recruited.|
714988|NCT03321253||
714989|NCT03321097||
714990|NCT03320941|126 participants were randomized and received at least one dose of study drug.|
714991|NCT03320824||
714992|NCT03320564||
714993|NCT03320369||
714994|NCT03320096|The study was conducted at 2 sites in Germany.|A total of 20 participants were screened, enrolled and treated in the study.
714995|NCT03319810||
714996|NCT03319719|The study was conducted at 3 investigative sites in the United States.|A total of 65 participants were screened, out of which 52 participants were randomized and treated. Of these, 51 participants completed the study.
714997|NCT03319407||
714998|NCT03319277||
714999|NCT03319212|A total of 105 subjects were enrolled into this study. Of those enrolled 81, were dispensed a study lens while 24 subjects failed to meet all eligibility criteria. Of those dispensed a study lens, 73 completed the study while 8 subjects were discontinued. All subjects were disepsned the same study lens senofilcon A.|Subjects were stratified into two subject groups: symptomatic (baseline CLDEQ-8 score of 15 or greater) and asymptomatic (baseline CLDEQ-8 score of 7 or lower).
715000|NCT03319173||
715001|NCT03319134||
715002|NCT03318861|Participants were enrolled at study sites in the United States. The first participant was screened on 20 October 2017. The data cutoff occurred on 19 May 2019.|21 participants were screened.
715003|NCT03318341||
715004|NCT03318315|Healthy adult participants 19-64 years of age were recruited from the communities surrounding each clinical site, and were enrolled between 20FEB2018 and 29JUN2018.|
715005|NCT03317431||
715006|NCT03316976|Participants took part in the study at 1 investigative site in China from 22 November 2017 to 08 February 2018.|Healthy Chinese participants were enrolled in this two arm study to receive single oral dose of dexlansoprazole 30 and 60 milligram (mg) delayed-release capsules.
715007|NCT03316911|Participants were recruited from the mandatory primary prevention training sessions, Relationship Remix, offered to all incoming students at the University of Michigan. We specifically recruited in October 22, 2017 - November 17, 2017 from Alice Lloyd Residence Hall (control) and Mosher Jordan Residence Hall (intervention).|
715008|NCT03316378||
715009|NCT03316131|The trial was conducted at two study centres: Baltimore and Los Angeles. The date of the first subject visit was 25 Oct 2017 and the date of the last subject last visit was 19 Jul 2018. A total of 36 adults asymptomatic hyperuricemic patients were included into this study.|Patients who provided informed consent underwent screening procedures within the 28 days. Patients returned to the Clinical Unit on Day -2 of Treatment Period 1 and were randomized (1:1) to two treatment sequences ( treatment AB or BA).
715010|NCT03316105||
715011|NCT03315949||
715012|NCT03315780||
715013|NCT03315702||
715014|NCT03315689||
715015|NCT03315572|This was a cross-sectional, qualitative study to develop items to evaluate ease of use of ELLIPTA by pediatric participants with asthma and their caregivers for implementation in clinical trials.|Two iterative rounds of interviews were conducted in 14 dyads, each containing one caregiver and one pediatric participant with asthma (a total of 28 participants). All the interviews were conducted in Raleigh, North Carolina and Southfield, Michigan.
715016|NCT03315559|The study was conducted at a single center in the United Kingdom from 14-November-2017 to 22-December-2017.|A total of 7 participants were screened, of which 1 participant was a reserve participant and was not used. The remaining 6 participants were enrolled.
715017|NCT03315286|We recruited 14 patients with kidney transplantation & actinic keratosis from 10/2018 to 4/2018. We recruited another 97 patients with only a history of actinic keratosis without a history of kidney transplantation between 4/2018 and 7/2018. Patient were all recruited at one academic institution. We are presenting the data of the 97 patients.|
715018|NCT03315104|This study included patients hospitalized with serious illness with laboratory-confirmed influenza A infection. Total 75 subjects were screened with 10 screen failures. Out of 65 randomized subjects, 60 received study treatment and 53 completed the study.|
715019|NCT03314857|Each study site was allowed up to two roll-in patients. Per the protocol, roll-in patients completed all study visits and procedures but were not part of the analysis. Six of the 67 patients enrolled were roll-in patients.|
715020|NCT03314753|"110 patients reported a re-ablation in the original FIRE AND ICE Trial. Of those 110, 89 consented for the FIRE AND ICE Re-Ablation study. All data available in retrospective chart review from the 89 subjects were included in analyses. No patient data was excluded.
~The first re-ablation for each patient was included in the analysis."|
715021|NCT03314662|20 study centers in the United States|All enrolled subjects were randomized.
715022|NCT03314519||
715023|NCT03314233||
715059|NCT03306641||
719752|NCT02612623|Male and female participants with treatment-refractory chronic cough were enrolled in this study.|
715024|NCT03313310|Participants will be recruited in clinics serving young men who have sex with men (YMSM) and young transwomen (YTW) of color, and local gathering places for YMSM and YTW. Participants will be asked to refer potentially eligible friends or acquaintances. Passive recruitment will include posting study flyers and describing the study on social media.|
715025|NCT03313050||
715026|NCT03313037||
715027|NCT03312933||
715028|NCT03312543||At Visit 1 (Screening), participants were enrolled in the study and randomized to the active cell or the sham cell (stratified by skin type). All participants received the same facial cleanser and moisturizer with SPF to use between Visit 1 and Visit 2, and then received the assigned test product (Active Mask or Sham Mask) at Visit 2 (Baseline).
715029|NCT03312517||Presence of insomnia determined by clinical interview performed by a physician board certified in sleep medicine
715030|NCT03312348||
715031|NCT03312231|Participants were healthy males and non-pregnant females aged 19 years and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 14FEB2018 and 05SEP2018.|
715032|NCT03312114||
715033|NCT03311841||
715034|NCT03311659||
715035|NCT03311646||Participants were screened for eligibility prior to the baseline condition. Participants were then required to return to the lab on a designated date to complete an additional drug screen and begin the hotel phase. Participants could withdraw or be lost to follow up between screening and baseline.
715036|NCT03311373|This study was conducted at a single center in the United States from November 2017 to December 2017.|"Elig subj. received single dose of BGF MDI (Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler) 320/28.8/9.6 μg as:
~Regimen A: BGF MDI w/out spacer, w/out charcoal Regimen B: BGF MDI with spacer, w/out charcoal Regimen C: BGF MDI w/out spacer, with charcoal Regimen D: BGF MDI with spacer, with charcoal"
715037|NCT03311230||
715038|NCT03310775|The participants were recruited from the Child and Adolescent Psychiatric Clinic at Seoul National University Bundang Hospital, through advertisements at the Smile Together Foundation (a local advocacy institute of ASD), a community of child and adolescent psychiatrists, an internet group of families of youth with ASD.|Ten participants were excluded during the randomization procedure; six were not adequately motivated, one did not meet the diagnosis of ASD, one had difficulty understanding self-report scales, one had a problem with school, and one had to fulfill a military commitment.
715039|NCT03310723||
715040|NCT03310580||
715041|NCT03310450|Consecutive sampling was done by voluntary confirmation of participants in the 2017 North Coast tour (http://ina-northcoast-cyclingtour.com/index.html) and the 2017 Tour de Borobudur (https://event.sambabikers.com/). All participants were invited to participate in this observational study via an online advertisement on the website.|Participants with a history of coronary artery diseases (CAD) were excluded from study participation. Subsequently, a total of 94 participants were included in this study
715042|NCT03310411||Crossover study with four periods. Participants were randomized to one of four treatment (Treatment A: 200 milligram (mg) lasmiditan + 100mg sumatriptan, Treatment B: 200mg lasmiditan + placebo, Treatment C: 100mg sumatriptan + placebo, Treatment D: placebo + placebo) period sequences. There was a washout of at least 4 days between each dosing day.
715043|NCT03310268|Participants were recruited from one center in China.|A total of 688 participates were screened, out of which 185 participants were randomized in the study and 503 participants were not randomized as 474 participants did not meet study criteria, 6 were reported with adverse events, 3 because of protocol violation, 4 withdrew consent, and 3 because of unspecified reasons.
715044|NCT03310021|Healthy Subjects|One subject in cohort 10 (Edoxaban/Placebo) discontinued due to protocol deviation (mis-enrolled, inclusion criteria #10 not met(weight>80kg). This subject (100003) is not summarized in tables because he/she did not receive any andexanet/Placebo. The safety population (N=107) is defined as having received study drug andexanet/placebo.
715045|NCT03309943|Participants were enrolled in a laboratory setting at Duke University School of Medicine during a period ranging from January 2018 to June 2019.|
715046|NCT03309787||
715047|NCT03309696||
715048|NCT03309657||
715049|NCT03309202|Recruitment for participants in Cohorts 3 and 4 initiated first and recruitment for participants in Cohort 2 started when approximately 50% of total participants across Cohorts 3 and 4 had been dosed. Participants in Cohort 1 were recruited last to match the average demographics across the pooled Cohorts 2 through 4.|A total of 24 subjects with 4 varying degrees of hepatic function were enrolled into the study to ensure that up to 6 evaluable subjects in each of the 4 hepatic function cohorts complete the study.
715050|NCT03309072|"Age between 18 and 35
~Currently not using any medication
~Native English speaker
~Capable of understanding and signing an informed consent"|
715051|NCT03308968||A total of 838 participants were randomized in a 1:1:1 ratio to placebo, fremanezumab quarterly, or fremanezumab monthly treatment groups.
715052|NCT03308825|Study participants were enrolled in 3 centers in the United States from 11 September 2017 to 25 October 2017.|A total of 240 participants were enrolled and vaccinated in the study.
715053|NCT03308799|First Subject First Visit: 03-Oct-2017. Last Subject Last Visit: 08-Jun-2018.|Prior to randomization, the subject entered a washout period (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The washout/screening period could last for up to 30 days, depending on which disallowed treatments the subject received.
715054|NCT03308669||
715055|NCT03308058|There were 46 mothers included in the study.|
715056|NCT03307252|The trial consisted of 3 parts investigating different drug transporter inhibitors. All parts of the trial were performed in healthy male participants in a randomised, open-label, three-way (Part 1) or four-way (Part 2 and 3) crossover design.|All participants were screened for eligibility to participate in the trial. Participants were not to be randomised to trial treatment if any of the in- or exclusion criteria were violated at screening.
715057|NCT03307174|Patients were enrolled between December 2016 to December 2018|"Patients were not randomized to study groups if epidurals were not able to be successfully placed.
~2 subjects in the CEI group were no included in the analysis due to missing data
~1 subject in the PIEB group was not included in the analysis due to missing data"
715058|NCT03307005||
715060|NCT03306589|This study aimed to assess 2 models of systemic inflammatory response: exposure of healthy participants to systemic challenge with either Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF).|Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
715061|NCT03306420|First Participant First Visit: 03-Oct-2017 Last Participant Last Visit: 14-Jan-2019.|
715062|NCT03306277|22 participants were recruited across 16 study centers in the United States.|A screening period of up to 30 days occurred before treatment.
715063|NCT03306199||
715064|NCT03306043|This was a multi-center, open-label extension study to evaluate the long-term safety profile of mepolizumab in participants with Hypereosinophilic Syndrome (HES). In this study, participants received open-label mepolizumab 300 milligram (mg) subcutaneously (SC).|A total of 102 participants who completed the parent study (200622 [NCT02836496]) and met the eligibility criteria were enrolled in this open-label extension study.
715065|NCT03305887||
715066|NCT03305822||
715067|NCT03305770|Subjects were recruited from 6 investigational sites located in the US.|This reporting group includes all randomized subjects (107).
715068|NCT03305731||
715069|NCT03305575||
715070|NCT03305419|This study consisted of two parts; part A was single ascending dose, 3-way crossover and part B was repeat dose, sequential assignment which investigated the safety, tolerability, and pharmacokinetics of GSK2982772, in healthy participants.|A total of 62 participants (15 in Part A and 47 in Part B) were enrolled in the study. Participants were not enrolled into the GSK2982772 360 milligram (mg) twice daily (BID) arm of Part B as one participant in the 360 mg BID dose level in Part A exceeded the maximum concentration (Cmax) stopping criteria.
715071|NCT03305159||
715072|NCT03305055||
715073|NCT03304873||
715074|NCT03304119||
715075|NCT03304106||
715076|NCT03303950||
715077|NCT03303911||
715078|NCT03303794||
715079|NCT03303521||
715080|NCT03303417|16 healthy volunteers were recruited from the population of Nottingham and surroundings. 2 dropped out after a single visit due to unexpected work commitments so 14 volunteers completed the study|
715081|NCT03303404||
715082|NCT03303196||
715083|NCT03303144||All 27 participants in the study were randomly assigned to cross-over between the three treatments on Day 3, Day 8 and Day 10.
715084|NCT03302975||
715085|NCT03302936||
715086|NCT03302793||
715087|NCT03302780||
715088|NCT03302741||
715089|NCT03302559||
715090|NCT03302416||45 subjects screened, 19 assigned to interventions
715091|NCT03302247||
715092|NCT03301844|Patients were enrolled between May 2017 and January 2018 at the Ophthalmology Unit of the Magna Graecia University of Catanzaro in Italy|During a 2-week run-in period starting at Visit 1, and after the patient has provided informed consent, the Investigator will collect demographic data and medical history and perform a physical examination of the patient.
715093|NCT03301779||Participants were immediately assigned to a group upon enrollment.
715094|NCT03301740||
715095|NCT03301714||
715096|NCT03301649|A total of 912 infested household participants were included and 911 (905 enrolled [380 index + 525 non-index] + 6 non-enrolled) were treated. Participants were randomized in 3:3:1 to generic ivermectin, Sklice (ivermectin), or vehicle lotion. 1 participant was considered randomized but not dispensed, so not included in any treatment arm.|"Non-enrolled infested participants: Any household member who was infested with lice and agreed to be treated with study drug but did not participate in the study.
~912 infested patients were available to participate in the study, one patient was not dispensed study product, 911 patients (905 enrolled + 6 non-enrolled) were treated."
715097|NCT03301298||
715098|NCT03301272||
715099|NCT03301155||
715100|NCT03300843||
715101|NCT03300674||
715102|NCT03300570||37 patients were pre-registered, where 10 were screen failures, leaving 27 patients who proceeded to randomization.
715103|NCT03300466||
715104|NCT03300024||
715105|NCT03299686|Participants were from Argentina (2), Belgium (3), Germany (5), Denmark (4), France (2), Israel (3), Slovakia (2), The United States (7)|After an initial screening visit, run-in period and baseline assessments, the eligible subjects entered the treatment period and were randomized in a 3:2 ratio to one of the two treatment groups.
715106|NCT03299101||
715107|NCT03299049|This non-inferiority study evaluated antiviral activity of cabotegravir(CAB) long acting(LA) 600 milligrams(mg) + rilpivirine(RPV) LA 900 mg administered every 8 weeks(Q8W) compared with CAB LA 400 mg+RPV LA 600 mg administered every 4 weeks(Q4W) over a 48-week period in virologically suppressed human immunodeficiency type 1 infection participants.|A total of 1049 eligible participants were randomized in a ratio of 1:1 to 1 of the 2 treatment arms in Maintenance Phase, of which 4 participants did not receive study treatment and 1045 participants were included in Intent to treat-Exposed Population. Results presented are based on Week 48 primary analysis.
715108|NCT03298867||Results data presented corresponds to the completion of the Double-Masked Treatment Period (last patient last visit, 13 February 2019; data cut-off date, 19 February 2019).
715109|NCT03298412|The study enrolled participants from Australia, France, Greece, Italy, Switzerland, and the United States. The first participant enrolled on 23 May 2018, and the last participant enrolled on 05 August 2019.|The study included a Screening period (up to 28 days), and a run-in period of up to 24 months to evaluate minimal residual disease (MRD) status and assess eligibility for treatment assignment.
715110|NCT03298113||
715111|NCT03298048||2 of the 17 enrolled did not start treatment: one did not start treatment due to physician's concerns about patient taking bowel prep, and the second did not start treatment because of hospitalization.
715112|NCT03298035||
715113|NCT03297944||All 15 participants received every intervention.
715114|NCT03297294||Three hundred six patients were screened and 137 randomized
715115|NCT03297112||
715116|NCT03297021|165 patients assessed for eligibility 141 patients were randomized|
715117|NCT03296787|Participants took part in the study at 4 investigative sites in Czech Republic and Hungary from 21 November 2017 to 09 August 2019.|Participants with normal renal function and renal impairment were enrolled in 1 of the 4 groups: A (healthy), C (moderate), D (severe), and E (end-stage renal disease [ESRD]) to receive TAK-954 0.2 milligram (mg). Based on available safety and pharmacokinetics (PK) data from Group C, participants were not enrolled in Group B (mild).
715118|NCT03296566||297 participants were recruited and subsequently randomized. Post-randomization, 3 participants withdrew from the control arm. 294 patients were analyzed in the statistical analysis.
715119|NCT03296280|10 facilities were to participate in the first 6 POCUS course session during FY17. 10 facilities were to participate in the last 6 POCUS course sessions during FY17. Participants, rather than facilities, were recruited and assigned to to the early or late intervention arms.|
715120|NCT03296072|Participants were recruited from one center in United States of America.|A total of 68 participates were screened, out of which 62 participants were randomized in the study and 6 participants were not randomized as all the 6 participants did not meet study criteria.
715121|NCT03295630|20 hospital ward based participants recruited. Recruitment period September 2016 to April 2017|
715122|NCT03295266|The study terminated prior to enrollment of any healthy control participants.|Participants with moderate or severe hepatic impairment (HI) based on estimated glomerular filtration rate (eGFR) were enrolled at 2 study centers in the US.
715123|NCT03295201|Recruitment period was March 2017-October 2017 Setting: A university hospital outpatient clinics|Number of patients assessed for eligibility was 30. Among them,8 participants were excluded due to being inappropiate for the inclusion criteria (6 were out of age limits, 2 did not agree to participate in the study)
715124|NCT03294681|153 participants were recruited in six centres from 03 October 2017 to 29 May 2019.|
715125|NCT03294629|March 2015 to Mar 2016, at medical clinic.|
715126|NCT03294538|The populations for this study included the Safety Population, the modified Intent-to-Treat (mITT) population, and the Per-Protocol (PP) Population.|Following the 14-day screening period, participants who continued to meet the inclusion/exclusion (I/E) criteria were randomly assigned to treatment on a 2:2:1 ratio of generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01%; Estrace Vaginal Cream USP, 0.01%; or vehicle vaginal cream.
715127|NCT03293654||
715128|NCT03293485||
715129|NCT03293394||
715130|NCT03293238|Patients were recruited through individual physician practices.|Sixty-three patients were enrolled and randomized into four groups: Group 1: Joint Line Ultrasound Guided (n= 19), Group 2: Joint Line Landmark Based (sham Ultrasound) (n= 16), Group 3: Suprapatellar Ultrasound Guided (n= 14), Group 4: Suprapatellar Landmark Based (sham Ultrasound) (n= 14). One patient's radiographic imaging was lost.
715131|NCT03292692||
715132|NCT03292640||
715133|NCT03292614||
715134|NCT03292562||
715135|NCT03292016||
715136|NCT03291613||
715137|NCT03291288|A total of 32 participants who met all inclusion and no exclusion criteria were enrolled in the study; 2 participants did not receive pexidartinib treatment.|This open-label, single sequence crossover study comprised of 2 parts. Part 1 was the initial single sequence crossover part to evaluate the effect of pexidartinib on the pharmacokinetics of midazolam and tolbutamide, the drug-drug interaction (DDI) phase. Part 2 was an evaluation of efficacy and safety of pexidartinib treatment in various tumors.
715138|NCT03291197|Recruitment period was from September 2017 to 2018. This was a 12 month period in which patient with shoulder and hand pain following stroke were recruited.|All participants were recruited to for suprascapular and median nerve blocks once a diagnosis of shoulder-hand-syndrome was made using the Budapest criteria
715139|NCT03290768||
715140|NCT03290378||
715141|NCT03290300||
715142|NCT03290027||
715143|NCT03289858||
715144|NCT03289676||
715145|NCT03289533|Participants with advanced hepatocellular carcinoma (HCC) who did not receive any prior systemic therapy were enrolled in this study.|
715146|NCT03289481|This study was a cross over case-control study (each subject was a control for themselves).|
715147|NCT03289234||
715148|NCT03289208||
715149|NCT03288779|We recruited 6 patients with diagnoses of schizophrenia, which included 4 inpatients and 2 outpatients.|
715150|NCT03287869||The study included participants who completed 3-week double-blind treatment in studies 331-201-00080 (NCT03259555)/331-201-00081 (NCT03257865) and, who in the investigator's judgment, could potentially benefit to receive brexpiprazole in this study. Data was summarized as per the treatment received in the previous studies.
715151|NCT03287843||
715152|NCT03287804|Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients were treated with doses from 15 x 10⁶ to 350 x 10⁶ APRIL CAR T Cells.|Screening procedures were performed up to 12 weeks before study treatment administered
715153|NCT03287791|The populations for this study included the Safety Population, the modified Intent-to-Treat (mITT) population, and the Per-Protocol (PP) Population.|If participant failed to return diary card and had no evidence of study drug use, then •participant was included in Safety population if there was some participant safety or efficacy data after Baseline •participant considered lost to follow up and excluded from Safety Population if there was no participant safety or efficacy data after Baseline
715154|NCT03287622||
715155|NCT03287089|Consecutive women were prescreened for eligibility and introduced to the study prior to surgery. Women with postoperative urinary retention following pelvic organ prolapse and/or incontinence surgery were approached for study inclusion at the time of their postoperative in-office voiding trial between September 2017 and April 2019.|"Women were deemed as enrolled once they consented and randomized. No enrolled participants were excluded with this definition."
715156|NCT03286829||
715157|NCT03286751||This was a 6-period crossover study in which participants received a single 7 Unit (U), 15 U, or 30 U subcutaneous (SC) dose of LY900014 or Humalog in one of six sequences. There was a washout period of ≥ 3 days between each euglycemic clamp procedure.
715158|NCT03286400||
715159|NCT03286283||All participants who were enrolled were assigned to a/the treatment group.
728891|NCT01870973||
715160|NCT03286218||Qualification Phase: Participants randomized in a 2-period crossover design with a washout period of at least 72 hours Treatment Phase: Participants randomized to 1 of 10 dosing sequences, irrespective of their qualification randomization, in a 5-period crossover design with a washout period of 3 days in between doses.
715161|NCT03285984|Participants were recruited at a single center in the United States.|A Total of 56 participants were screened and randomized in the study. All 56 participants completed the study.
715162|NCT03285724||
715163|NCT03285711|Participants were enrolled at study sites in United States. The first participant was screened on 06 October 2017. The last study visit occurred on 03 February 2020.|22 participants were screened.
715164|NCT03285555||
715165|NCT03285542||
715166|NCT03285529||
715167|NCT03285373|Patients with Non Valvular Atrial Fibrillation (NVAF) in Spain, mainly from the hospital setting were on treatment with New Oral Anticoagulant (NOAC) according to its approved local Summary of Product Characteristics (SmPC) and have initiated their first NOAC starting from November 2016 were included in this trial.|All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites in Spain to ensure that subjects met all incl/excl criteria. 45 patients (out of 1008 enrolled), did not meet at least one of the selection criteria and were considered not eligible. Data analysis was carried out with 963 eligible patients.
715168|NCT03285295|Alinity s HBsAg: 17987 Alinity s HTLV I/II: 17685 Alinity s Anti-HCV: 17904 Alinity s HIV Ag/Ab Combo: 19571 Alinity s Anti-HBc: 16776 Alinity s Chagas: 16958|
715169|NCT03284411||
715170|NCT03284229||31 patients were screened. 3 patients were screen failure. 28 patients enrolled in the study.
715171|NCT03283787||
715172|NCT03283709||
715173|NCT03283696||Completers included participants who died from any cause, participants with progressive disease.
715174|NCT03283436||
715175|NCT03283319||
715176|NCT03283098|This study was conducted at 5 centers in China.|Of the 37 subjects screened, 33 participants were randomized in a 3:1 ratio to either etelcalcetide or placebo in a double-blind manner prior to the Day 1 activities.
715177|NCT03282682||
715178|NCT03282591||
715179|NCT03282240|Study participants were screened in 35 centers in the Unites States (US) from 08 September 2017 to 15 September 2017.|A total of 2670 participants were randomized in the study.
715180|NCT03282227||
715181|NCT03282071|recruitment period: Aug-Oct 2017; types of location: family service centres|8 parents excluded (not meeting inclusion criteria 18-59 years)
715182|NCT03281668||
715183|NCT03281577|Participants took part in the study at 1 investigative site in the United States from 02 January 2018 to 12 July 2019.|Participants with a diagnosis of diabetic or idiopathic gastroparesis were enrolled and randomized in 1:1:1:1 ratio to receive TAK-954 0.1 mg, 0.3 mg, 1 mg or placebo.
715184|NCT03281200|Non-interventional study based on medical charts was conducted in approximately 35 pulmonology services in Spanish hospitals. Idiopathic pulmonary fibrosis (IPF) patients were characterized at the time of nintedanib initiation. Analysis of this report was performed using the data collected in the database from 21October2017 up to 31January2018.|All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be analyzed if any one of the specific entry criteria were not met.
715185|NCT03280615||
715186|NCT03280550||At the first visit of the 5-week screening/run-in period, participants were asked to standardize their nasal corticosteroids to a regimen of mometasone, 200 micrograms twice a day (BID). If intolerant to a BID regimen, then they remained on a stable dosage of mometasone once a day (QD) during the run-in period and throughout the treatment period.
715187|NCT03280537||At the first visit of the 5-week screening/run-in period, participants were asked to standardize their nasal corticosteroids to a regimen of mometasone, 200 micrograms twice a day (BID). If intolerant to a BID regimen, then they remained on a stable dosage of mometasone once a day (QD) during the run-in period and throughout the treatment period.
715188|NCT03280381||
715189|NCT03280108|Subjects were recruited from 12 investigative sites located in the United States.|Of the 250 enrolled, 7 subjects were exited as screen failures prior to attempted implantation. This reporting group includes all subjects with at least one eye implanted (243).
715190|NCT03279731|"Participants were recruited at university based medical school clinic setting. The first participant was randomized on September 29, 2017; the last participant completed participation on September 6, 2019.
~Note: 9 participants were censored from the trial due to an error in medication/placebo assignment by the Investigational Drug Service. As such, these 9 participants were not considered in any of the analyses presented, leaving 13 in the liraglutide and 14 in the placebo group."|Participants underwent a 2 week run in to assure that they continued to have binge episodes before being randomized to placebo or liraglutide 3.0 mg.
715191|NCT03279458||
715192|NCT03279237||
715193|NCT03278886||
715194|NCT03278106||
715195|NCT03278067||One study General Practitioner (GP2) did not follow the procedure as per protocol in distributing, handling of the returned cards and the unused Adverse Drug Reaction (ADR) cards, therefore the data from that GP were excluded from the analysis.
715196|NCT03278028||
715197|NCT03277846||
715198|NCT03277274|Participants took part in the study at 2 investigative sites in Czech Republic and Slovakia from 09 November 2017 to 10 September 2018.|Participants with normal hepatic function and hepatic impairment were enrolled in 1 of the groups:B(moderate), C(severe) or D(healthy) to receive TAK-954 0.2mg. Based on available safety and PK data from Group B, participants were enrolled in reduced study design and were not enrolled in GroupA(mild). Groups A-D are equal to Groups 1-4 in protocol.
715199|NCT03277183||
715200|NCT03277105||
715240|NCT03267511|Participants were recruited from one center in USA|A total of 137 participates were screened, out of which 123 participants were enrolled and randomized in the study. 14 participants were not randomized as 11 participants did not meet study criteria, 2 participants withdrew by consent and 1 participant was lost to follow-up.
715241|NCT03267264||
715242|NCT03267212||
715201|NCT03276936|This open-label, multi-center, 40-week extension study was conducted at 70 sites in the United States from 05 September 2017 to 03 January 2019, and enrolled participants from previous double-blind (DB) studies FX2016-11 and FX2016-12.|Baseline for the study was conducted at the same time as Visit 5/Week 12 (Final Visit) of Study FX2016-11 or Study FX2016-12. All assessments performed at Visit 5/Week 12 (Final Visit) of Study FX2016-11 or Study FX2016-12 were not repeated but rather recorded as the same assessments at Baseline for this study.
715202|NCT03276871||
715203|NCT03276494||
715204|NCT03276078|This study was conducted at a single centre in China. The first participant was enrolled in December 2017 and the last participant visit was in June 2018.|A total of 97 participants were screened. Of these, 20 were enrolled and received treatment.
715205|NCT03276026||
715206|NCT03275870||
715207|NCT03275623||
715208|NCT03274986|Subjects were recruited from 11 investigative sites located in the United States.|21 subjects discontinued prior to randomization, and 1 subject discontinued after randomization but prior to attempted implantation. This reporting group includes all subjects with attempted implantation, as treated. Note: 1 subject randomized to DFT015 was implanted with SN60WF. Subject withdrew at the 1 month visit.
715209|NCT03274856|Five additional participants screened but not randomized|
715210|NCT03274518||
715211|NCT03274453||
715212|NCT03274440|"Participants were randomized to receive high THC/low CBD cannabis (THC), low THC/high CBD cannabis (CBD), and placebo cannabis (PBO). Total participants for each order were:
~Order A (THC, CBD, PBO) = 3 Order B (THC, PBO, CBD) = 2 Order C (CBD, THC, PBO) = 4 Order D (CBD, PBO, THC) = 1 Order E (PBO, THC, CBD) = 1 Order F (PBO, CBD, THC) = 3"|Participants who met study criteria and chose to participate were assigned to receive each of the three study conditions (high THC/low CBD; low THC/high CBD; placebo with no THC or CBD) in random order. All sessions were separated by at least 1 calendar week.
715213|NCT03274076|Participants were recruited from University of Michigan and University of Pittsburgh Scleroderma clinics. The recruitment period began in September 2017 and ended with the last participant randomization in October 2018.|
715214|NCT03273946|This was a single arm non-interventional, post-marketing safety monitoring study to evaluate safety of Chinese participants aged 1 to <4 years when using Flixotide 50 micrograms (μg) via a pediatric spacer device with a face mask in clinical practice. No medical intervention was received by participants during conduct of this study.|Total 158 participants were enrolled into this study. The study was conducted at 4 centers in China.
715215|NCT03273673||
715216|NCT03273543||
715217|NCT03273426|Sep 2016 to Feb 2018 at Breast Care Center, Seoul National University Hospital|All enrolled patients completed the protocol for minimally-invasive biopsy and subsequent wide excision.
715218|NCT03273387|Subjects were recruited from NCCHK PH outpatient clinic from September 2017 until November 2018|A total of 35 Patients were enrolled between September 2017 and November 2018 at NCCHK PAH outpatient clinic. A total of 26 patients were consent to underwent the trial and randomly assigned to receive trimetazidine or placebo with ratio 1:1.
715219|NCT03273283||
715220|NCT03273166||Fingers were not randomized to the two interventions. All participants received both interventions in the exact same manner.
715221|NCT03273153||
715222|NCT03272711||Twenty-nine participants were not assigned to a group. Twenty did not meet eligibility criteria for randomization, 8 individuals declined to participate further and one person was a pilot participant.
715223|NCT03272139||
715224|NCT03271424||
715225|NCT03271307|Participants were recruited during routine health services at participating facilities. For Aim 1, participants were recruited from September 18, 2017 - February 19, 2018. For Aim 2, participants were recruited from March 21, 2018 - June 13, 2018.|
715226|NCT03271021||
715227|NCT03270657||
715228|NCT03270644||Open-label fixed-sequence study in which participants received a single oral dose of lasmiditan 200 mg on Day (D) 1 Reference Treatment (R), then propranolol 80 mg administered orally twice daily from Day 4 through Day 10 Reference Treatment, with one single oral dose of lasmiditan 200 mg on Day 9 Test Treatment (T).
715229|NCT03270436||
715230|NCT03270085||
715231|NCT03269968||The study was terminated due to insufficient enrollment. No study data are available.
715232|NCT03269552||4 participants signed informed consent, met eligibility and continued on to study treatment.
715233|NCT03268941|Participants took part in the study at 7 investigative sites in the United States from 26 September 2017 to 09 March 2018.|Participants with a diagnosis of diabetes mellitus and gastroparesis (GP) or with idiopathic gastroparesis (IG) were enrolled. 51 participants were randomized in Part 1, out of which 48 completed the Part 1, 21 of 48 participants entered the Part 2.
715234|NCT03268746|Subjects were recruited from 4 study centers located in Korea.|Of the 52 enrolled, 7 subjects exited as screen failures prior to implantation. This reporting group includes all implanted subjects (45).
715235|NCT03268590|41 persons responded to study advertisements and were screened for eligibility between September 2017 and April 2018. 33 were studied.|
715236|NCT03268343||
715237|NCT03268005|The trial was conducted at 165 sites in 17 countries as follows: Argentina-3, Bulgaria-4, Canada-10, Croatia-4, Czech Republic-4, Germany-6, Greece-8, Italy-4, Poland-10, Republic of Korea-6, Romania-6, Russia-8, Serbia-9, Slovakia-5, Spain-8, Ukraine-6 and United States (US)-62. Two sites in the US screened but didn't randomise any subject.|There was a 12-week run-in period primarily for optimisation of the basal insulin and reinforcement of subject training in trial procedures, diabetes education and dietary training. Out of the 1264 participants enrolled in the study, 173 were run-in failures and 1091 were randomised.
715238|NCT03267940|The study was conducted in 2 portions: Run-in portion and Expansion portion.|The study was terminated prematurely by the Sponsor due to stopping the clinical development of PEGPH20 in all indications based on negative pivotal data in metastatic pancreatic cancer.
715239|NCT03267576||A total of 64 participants were enrolled in this study but 1 participant has withdrawn consent before assigning to any study treatment hence, 63 participants were randomized to study treatment arms.
715499|NCT03210961||A total of 208 potential participants were screened after signing an informed consent form, of whom 109 participants were randomized to receive study treatment.
715243|NCT03266588|The study was conducted at 103 centers in the United States.|A total of 3019 participants were screened for this open-label study. A total of 2867 participants entered the observational period, and 1908 participants subsequently enrolled in the long-term treatment period of whom 1800 received treatment. A total of 807 participants failed screening mainly due to failure to meet eligibility criteria.
715244|NCT03266419||
715245|NCT03266172|This was an open label, 3-part, single and repeat dose study conducted in healthy participants to assess modified release (MR) minitablets (MT) in a capsule and MR monolithic matrix (MM) formulations of GSK2982772 compared to immediate release (IR) tablet formulation of GSK2982772.|In this study, total 45 participants were enrolled.
715246|NCT03266107|Patients for the study were drawn from current low back pain clinic populations, referrals, and patient self-referral at two investigative sites in the U.S. from February 2018 to February 2019. Consecutively identified patients were screened for medical history and review of MRI for Modic/endplate changes and any excluded pain sources.|
715247|NCT03266094|A total of 60 children, ages 2 to 12 in the US, were enrolled into a single-arm trial. A total of 60 subjects were screened and consented.|
715248|NCT03265938|study was conducted from September 2017 until July 2019|
715249|NCT03265600|Participants were recruited from 11 metro-north Boston primary care Patient Centered Medical Homes via print and digital flyers, as well as referrals from primary and mental health care settings confirmed by a primary care provider. 465 participants were recruited.|All participants received a 60-minute introduction to mindfulness led by an MTPC group leader prior to randomization. The session included a conceptual/experiential mindfulness introduction, inquiry, and digital and print resources. Participants were able to decline study continuation after the 60-minute introduction and before randomization.
715250|NCT03265132||
715251|NCT03265119||
715252|NCT03264456||Three consented patients chose not to undergo the initial PET/MRI scan prior to the scan being performed. Additionally, one patient's images were lost to data corruption and the patient was not included in the final analysis.
715253|NCT03264248||
715254|NCT03264157||
715255|NCT03263806|Emergency department patients who had a Cardiac CT scan, were screened for the study. The doctors interpreting the CT scan notifies the research coordinator regarding potential eligibility of the patient to the study.|
715256|NCT03263702||
715257|NCT03262441|Participants were recruited from the University of Washington AIDS Clinical Trials Unit at Harborview Medical Center in Seattle. The first participant enrolled February 12, 2018 and the last participant enrolled in August 14, 2018.|
715258|NCT03262233||
715259|NCT03262012|This study was conducted at 75 study centers in Japan, from Aug 2016 to June 2018. This is an extension study of PT010006 and could take up to an additional 28 weeks.|Subjects were randomized in a 2:2:1:1 scheme.
715260|NCT03261999||
715261|NCT03261531||
715262|NCT03261167|This was a multicenter study conducted at 40 study centers in Japan, of which 38 centers enrolled participants.|A total of 131 participants were screened of which 7 participants were screen failures [reason being did not meet inclusion exclusion criteria (6) and withdrew consent (1)] and finally 124 participants were randomized (63 participants in the GSK1358820 240 units [U] group and 61 participants in the GSK1358820 400 U group).
715263|NCT03260894|This study was conducted at 73 centers in 14 countries.|
715264|NCT03260868|Participants were enrolled in the study at 6 sites in Canada and United States between 19 September 2017 and 02 October 2018.|A total of 15 participants were randomized in study. Randomization was stratified by glycated hemoglobin (HbA1c) (less than [<] 7.6 percent [%] and greater than or equal to [>=] 7.6%) value at screening visit. Assignment in arms was done using interactive response technology (IRT) in 1:1 ratio to either virtual or traditional approach group.
715265|NCT03260699||
715266|NCT03260595||
715267|NCT03260426||
715268|NCT03260205|The study was conducted at 49 sites in United States between 06 September 2017 (first participant enrolled) and 23 October 2018 (last participant completed).|A total of 284 participants were screened of them 85 participants were screen failures and did not receive any treatment. 199 participants (153 participants for SPD489 treatment and 46 participants for placebo treatment) were randomized, out of them 150 participants completed the study.
715269|NCT03259555||The trial population consisted of adult participants (18 to 65 years) diagnosed with bipolar I disorder displaying an acute manic episode with or without mixed features requiring hospitalization.
715270|NCT03259490|It was planned to include healthy male and female subjects in this randomised, open label study. They were recruited from the volunteers' pool of the study site.|This trial was a two-way crossover study. All subjects received the 2 treatments in randomised order.
715271|NCT03259425||
715272|NCT03259139||Participants were both randomly assigned to condition (i.e. non-violent, sword, gun conditions) and to be either a player or watcher.
715273|NCT03259087||
715274|NCT03258814|This study enrolled participants with axial spondyloarthritis (AS) at 7 study sites in Germany. Eligible participants were receiving treatment with adalimumab (HUMIRA®) based on therapist's decision and local label requirements, must have had a response to adalimumab and have been eligible for active physiotherapy.|An enrollment period of treatment initiation and response assessment for 3 to 5 months preceded Randomization. This study was terminated early due to slow enrollment. Up to study termination 17 patients met all inclusion and none of the exclusion criteria and were enrolled in the study. A total of 7 of these patients were randomized into the study.
715275|NCT03258762|This study was conducted in healthy Japanese and Caucasian male participants to evaluate safety, tolerability and pharmacokinetic (PK) parameters of Pyrimethamine. This study was conducted at a single center in Australia.|A total of 14 healthy participants were enrolled in this study.
715276|NCT03258710|This was a multi-center, single-arm study to assess efficacy and safety of tenofovir disoproxil fumarate (TDF) by switching at Day 1 from entecavir hydrate (ETV) to TDF in chronic hepatitis B envelope antigen (HBeAg)-positive and hepatitis B virus-deoxyribonucleic acid (HBV-DNA) undetectable participants.|A total of 75 participants were enrolled in the study.
715500|NCT03210701||
715501|NCT03210519||
716336|NCT03052972|Enrollment took place between Mar 2017 and Aug 2018 from the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study|
715277|NCT03258645|This retrospective study using existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry assessed the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation after the first ever ischemic stroke (3 months of follow-up thereafter) to prevent secondary stroke.|In this non-interventional study based on existing data, no patients were screened.
715278|NCT03257995||
715279|NCT03257865||The trial population consisted of adult participants (18 to 65 years) diagnosed with bipolar I disorder displaying an acute manic episode with or without mixed features requiring hospitalization. One participant randomized to brexpiprazole was not treated and excluded from the safety analysis set.
715280|NCT03257813||
715281|NCT03257657||
715282|NCT03257631|Participants were enrolled at 18 sites in France, Italy, Spain, UK, and the USA. The study consisted of 4 groups, for each of the following primary brain tumor types: diffuse intrinsic pontine glioma (DIPG), ependymoma, high-grade glioma, and medulloblastoma. The study is currently ongoing; results are reported as of 15 March 2019 data cutoff date.|In stage 1 approximately 9 participants were to be enrolled in parallel to each group. If two or more participants in a group achieved an objective response or long-term stable disease within the first 6 cycles of treatment (within the first 3 cycles for DIPG) an additional 11 participants were to be enrolled in that group.
715283|NCT03257410||
715284|NCT03257358||165 patients were enrolled but only 163 were treated and included in the Safety Set
715285|NCT03257202||All 12 patients received each of the 4 study arms.
715286|NCT03257189|"Participants were recruited via an established database at the clinical site, with the use of IRB approved flyers and posting on the clinical site website. The completely voluntary nature of participation in the study was emphasized.
~Subject recruitment and screening began July 17, 2017 and completed July 21, 2017."|
715287|NCT03256968||
715288|NCT03256851||
715289|NCT03256799|N of 1 trial|there was no multiple arms in this study and no multiple groups
715290|NCT03256695||A total of 423 participants with exacerbation-prone chronic obstructive pulmonary disease (COPD) were screened, of which 405 participants at 40 investigational centers in the United States met entry criteria and were considered to be eligible for enrollment into the study.
715291|NCT03256552|Conducted at 20 sites in Japan from January-September 2015. Entire period of study participation per subject was a maximum of 19 weeks. Planned target enrollment of 60 subjects.|This was a chronic dosing (7 days), 4-period, 4-treatment, placebo-controlled, crossover study. Each subject was randomized to 1 of 4 sequences. Each sequence included the four treatment groups. By-treatment sequence tabulations of the data were not pre-specified.
715292|NCT03256526||
715293|NCT03256253||
715294|NCT03256162|Potential participants were those who were admitted to St Patrick's University Hospital, Dublin, for treatment of a major depressive episode (either unipolar or bipolar depression) between 06.09.17 and 12.06.18.|Treatment-as-usual, by the participants' treating teams, continued throughout the entire trial.
715295|NCT03256136||
715296|NCT03255980|FPI: June 2017 LPO: July 2018|
715297|NCT03255902||
715298|NCT03255824||
715299|NCT03255733||
715300|NCT03255655|Patients 18 - 85 years previously diagnosed with unilateral Chronic Plantar Fasciitis (>90 days), where Standard of Care therapies had failed to reduce pain.|
715301|NCT03255382|Intent-to-treat (ITT) analysis set included all participants enrolled in the study (N = 120). Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 117).|A total of 120 participants were enrolled and included in the ITT population; 3 randomized participants discontinued prior to receiving any study drug and were excluded from the safety population.
715302|NCT03255291||
715303|NCT03255187|Recruitment was conducted on Agust, 2017 in Fenglin Campus, Fudan University. A total of 93 participants were assessed for eligibility and 70 of them were finally recruited.|
715304|NCT03254719||
715305|NCT03254602||
715306|NCT03254459||
715307|NCT03254147|Non-interventional study based on existing health insurance claims data|All patients were screened for eligibility to participate in the trial. Patients met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
715308|NCT03254134|A non-interventional study based on existing health insurance claims data. 5,146 and 13,115 patients were prescribed dabigatran and warfarin.|The Japanese patients diagnosed as Non-Valvular Atrial Fibrillation (NVAF) and newly treated with dabigatran and warfarin in the real world Japanese setting between April 2010 and June 2016 using the Medical Data Vision (MDV) database.
715309|NCT03252964|364 candidates were contacted. Of those, 52 enrolled.|
715310|NCT03252353||
715311|NCT03252015||
715312|NCT03251963||
715313|NCT03251937|Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and proceed in the study.|
715314|NCT03251482||The study was planned to be conducted in 2 parts: Part 1 (Dose- Escalation) and Part 2 (Dose-Response). After completion of Part 1, the sponsor made the decision to not move forward with Part 2 as there was sufficient data to make a determination of efficacy in Part 1. Part 2 was not conducted, hence endpoints for Part 2 are not reported.
715315|NCT03251326||
715316|NCT03250845|This study enrolled 30 patients with an immunodeficiency secondary to a hematologic disorder requiring immunoglobin substitution therapy from 1 academic center in Belgium. The last patient completed in December 2017.|
715317|NCT03250689|The study was conducted at single center in United Kingdom. This study was terminated early due to a change in the benefit risk profile of danirixin observed in another study NCT03034967, leading to cessation of the overall danirixin development program.|A total of 43 participants were screened, of which 23 were screen failures (23 participants did not meet inclusion/exclusion criteria). From the 20 participants who passed screening, 1 was not randomized due to study being terminated early. Hence, 19 participants were enrolled and received treatment in this study.
716120|NCT03090100||Out of total 1,048 randomized participants, 534 were assigned to receive Guselkumab + Placebo and 514 subjects were assigned to receive Secukinumab.
715318|NCT03250182|This study was conducted at a single center in the United States from August 2017 to December 2017.|"BGF MDI 320/14.4/9.6 μg oral inhalation as follows:
~Single-dose on the morning of Day 1 (Visit 3) followed by serial blood draws for 24 hours
~BID dosing every morning and evening on Day 2 through Day 7 approximately 12 hours apart
~Single-dose administration on the morning of Day 8 (Visit 5) followed by serial blood draws for 12 hours"
715319|NCT03249935||
715320|NCT03249909|Total enrolment was 109 subjects from 9 sites in the US, and was completed between 11 AUG 2017 and 12 JUN 2019.|All enrolled subjects were assigned to a treatment group and treated in compliance with the Instructions For Use. No subject was excluded from the intent-to-treat (ITT) and safety population during analysis.
715321|NCT03249779||
715322|NCT03249584|At the time of the primary objective assessment (Apr 2019), 106 subjects were enrolled. Enrollment ended Feb 2020 with 218 total subjects which will allow for assessment of secondary objective and long-term effectiveness and safety; follow-up continues. The secondary objective will be assessed and AE will be updated once the study has completed.|6 of 106 subjects exited prior to RF Ablation due to failing in/exclusion criteria, withdrawal of consent, etc. 100 subjects underwent RFA. For effectiveness, subjects were separated into 2 study Groups (Thoracic/Lumbar and Periacetabulum/Iliac Crest/Sacrum) based on the location of each subject's ablation(s); subjects were combined for safety.
715323|NCT03249454|We recruited 15 subjects.|2 enrolled participants were not assigned to an arm--one of these participant had leg edema that interfered with outcome assessment, and the second participant did not exhibit an H reflex due to a baclofen medication pump; therefore, these 2 participants were not randomized and did not start any intervention.
715324|NCT03249272||Due to the slow pace of recruitment, the sponsor withdrew funding for the study. Of the expected 75 participants, 31 were recruited. As was pre-specified, the regadenoson and adenosine groups were combined for analysis as these interventions are interchangeable.
715325|NCT03249116|Participants were 75 adolescents ages 13-17 on a continuum of social anxiety who were recruited through convenience and snowball sampling via local libraries and youth centers, social media, and other public venues.|
715326|NCT03248947||
715327|NCT03248882||
715328|NCT03248492|Participants who met all of the inclusion and none of the exclusion criteria were enrolled and randomized to treatment (Part 1) or received DS-8201a at the recommended dose (Part 2).|In Part 1, participants were randomized 1:1:1 to either 5.4 mg/kg, 6.4 mg/kg, or 7.4 mg/kg dose of DS-8201a. Two doses randomized 1:1 (6.4 mg/kg and 7.4 mg/kg) were further evaluated. In Part 2, all T-DM1 resistant refractory participants (cohort 2a) or T-DM1 intolerant (cohort 2b) received DS-8201a at the recommended dose.
715329|NCT03248141|Out of 41 screened participants, 11 were enrolled in this study. Study got terminated afterwards due to difficulty in enrolling the targeted number of participants.|
715330|NCT03247985|Participants were recruited at the Mayo Clinic in Rochester, Minnesota from June 2013 to June 2014.|
715331|NCT03247816||
715332|NCT03247790||
715333|NCT03247738|Between December 10, 2017 and July 17, 2018, there were a total of 99 STEMI patients with intent to undergo P-PCI that presented to our Institution, of whom 69 provided their written informed consent to participate in the study.|19 patients were not randomized because PCI was not performed or had newly identified exclusion criteria
715334|NCT03247673||
715335|NCT03246724|Patients were recruited from October 26th, 2017 to November 30th, 2019 at the outpatient eye clinic, Ophthalmology Department, Boston Medical Center.|Out of 327 patients enrolled, 283 completed study participation and 44 patients did not complete study participation as they were dropped or withdrew from the study. 22 patients were dropped before randomization and 22 patients discontinued from study after randomization due to reasons seen in the participant flow table.
715336|NCT03246672|Participants were recruited from January to March 2018. These participants were identified using electronic medical record data indicating that they had bariatric surgery for weight loss at one of four VA hospitals: West Roxbury, MA; Long Beach, CA; Palo Alto, CA; and Ann Arbor, MI.|33 participants provided verbal consent. Of those, 3 were unable to be reached and 30 were reached by telephone to complete baseline measures and were scheduled for their first intervention phone call. Of those 30, 29 participants were reached for the first intervention phone call, and 1 participant unable to be reached for further participation.
715337|NCT03246152|This is the number of enrolled patients that completed the study.|
715338|NCT03246061||420 patients screened for MRI Modic changes at levels L3 to S1 to achieve 140 enrollments. Patients with Modic changes at other levels or who had other primary etiologies for their low back pain (i.e. disc herniation, stenosis, facet joint) were excluded. An independent orthopedic surgeon medical reviewer confirmed eligibility prior to randomization. A pre-specified interim analysis was conducted when 60% of randomized patients completed their 3-month primary endpoint visit.
715339|NCT03245762||
715340|NCT03245619|This was planned to be a 3 part, dose escalation study; however, the study was terminated during Part A (Cohort 3) because a relationship between GSK3335065 and ventricular tachycardia in a participant could not be excluded. Hence, participants were not recruited in Cohorts 4 to 8 of Part A; Part B and Part C were not initiated.|A total of 55 participants were screened of which 33 failed screening and 4 were kept in reserve but not used. A total of 18 participants were enrolled in the study. The study was conducted in the United Kingdom. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
715341|NCT03245463||
715342|NCT03245398||
715343|NCT03244865||
715344|NCT03244800|The study was conducted across 5 sites in Germany between 04Sep2017 and 23Jan2018.|A total of 120 participants consented to participate in the study. Of which 55 were screen failures; 65 participants were randomised (46 to MEDI0382 and 19 to placebo).
715345|NCT03244618|Participants were recruited at a single center in Bristol, United Kingdom.|"Participants brushed for 4-6 weeks with fluoride toothpaste during run-in period between enrollment and randomization. 272 participants were enrolled out of which 263 were randomized. Reasons for participant not being randomized:
~Did not meet Baseline inclusion criteria (n=1)
~Withdrawal by subject (n=6)
~Lost to follow-up (n=2)"
715346|NCT03243981||
715502|NCT03210376|Patients were identified when scheduled for Robotic Prostatectomy. Eligible subjects were approached before scheduled surgery to obtain Informed Consent. Patients were recruited from November, 2017 through July, 2018.|
715347|NCT03243630|A total of 26 subjects were eligible for participation with 24 randomized after completion of the adaptation session. Reasons for exclusion after adaptation session included poor venous access (n=1) and a positive drug screen (n=1).|A total of 26 subjects were eligible for participation with 24 randomized after completion of the adaptation session.
715348|NCT03243305||
715349|NCT03243084|Recruitment ran from August 2017 - December 2017. This clinical trial utilized multiple recruitment strategies including UNC University Physical Therapy and Pain clinic locations, informational notify.unc.edu system, and jointheconquest.org along with the listing on clinicaltrials.gov|
715350|NCT03242941||If the pulmonary vein ablation succeeded and the subject was in sinus rhythm the study procedure started from the electrode testing. Alternatively, if the subject was still in AF, the electrode testing was performed after either the application of the dual stage pacing algorithm or the cardioversion, when the sinus rhythm was established.
715351|NCT03242863|Children were recruited from three childcare centers in central Pennsylvania between November 2017 and March 2019|
715352|NCT03242590||
715353|NCT03242434|This study was a longitudinal study which involved healthy participants and participants who had sustained a thermal injury. The study was conducted in United Kingdom. This study was terminated early prior to the full sample size being achieved as the development of the formulation was terminated.|A total 23 participants were screened for study of which 5 participants were screen failure and 18 participants were enrolled in the study.
715354|NCT03242408||
715355|NCT03241927|4 Participants consented, 1 with unstable CNS and not eligible, 2 withdrew consent. and 1 enrolled.|
715356|NCT03241862||
715357|NCT03241810|At the time of the study termination by the prior Sponsor (Merrimack Pharmaceuticals), 62 sites participated in the study (27 in North America and 35 in Europe).|
715358|NCT03241368|"187 subjects signed consent. Per the protocol, a subject was not considered enrolled until consent was signed and subject met inclusion/exclusion criteria. Of the 187 who signed consent, 158 were considered enrolled per the protocol. 29 were screen failures, i.e. they signed informed consent, but ended up failing inclusion/exclusion."|Of the 187 subjects who signed informed consent, 29 failed inclusion/exclusion criteria and were exited from the study. Criteria included labs, which caused some subjects to wash out at this early phase. This left us with 158 subjects. For various reasons, 39 additional subjects were exited prior to all imaging procedures being completed.
715359|NCT03241342||
715360|NCT03240575|The study compares treatment tiotropium+olodaterol (5μg/5μg) once daily FDC to Fluticasone propionate+Salmeterol (250μg/50μg) twice daily FDC over 12 weeks in patients with COPD. A Digital Health (DH)-study has been integrated a site specific study. The patients enrolled in the DH-study are not considered to be part of the main study.|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and non of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
715361|NCT03239873||
715362|NCT03239665||
715363|NCT03239522|This study evaluated the excretion balance of daprodustat(GSK1278863) using radiolabeled 14 Carbon [14C]-drug substance administered orally, and as an intravenous (IV) infusion, administered as a micro tracer dose (concomitant with an oral, non-radiolabeled dose) in healthy male participants.|Participants were enrolled at a single center in United Kingdom. A total of 6 participants were enrolled in the study. All the enrolled participants were randomized to receive study treatment.
715364|NCT03239496||
715365|NCT03239483||
715366|NCT03239106||
715367|NCT03238924||
715368|NCT03238911|A total of 310 subjects were screened and 123 subjects were randomised into the trial.|
715369|NCT03238781|A total of 510 subjects were screened.|"Participants were randomized 4:3:3 to placebo, AMG 301 210 mg Q4W, or AMG 301 420 mg Q2W, respectively. The randomization was stratified by
~chronic migraine versus episodic migraine and
~North America versus Rest of World."
715370|NCT03238352|Participants were recruited from one center in USA.|A total of 123 participates were screened, out of which 89 participants were enrolled and randomized in the study. 34 participants were not randomized as all the 34 participants did not meet study criteria.
715371|NCT03238001|Participants were enrolled at one site in the US.|450 participants were enrolled. 14 did not meet screening criteria.
715372|NCT03237871||
715373|NCT03237845|This study was conducted at 50 sites in United States of which 49 sites enrolled at least 1 participant.|A total of 1499 participants were enrolled, of which 1186 participants were randomized to rimegepant 75 milligram (mg) or placebo. A total of 313 participants failed screening mainly due to failure to meet eligibility criteria. The randomization was stratified in a 1:1 ratio based on use of prophylactic migraine medications (yes or no).
715374|NCT03237156|Participants took part in the study at 1 investigative site in Japan from 07 August 2017 to 07 October 2017.|Healthy male participants were enrolled in this study to receive TAK-906 as: single ascending dose and multiple ascending dose of 50 milligram (mg) in Cohort 1, 100 mg in Cohort 2, and 10 mg in Cohort 3.
715375|NCT03237065|A total of 244 subjects were screened and 122 subjects were randomised into the trial.|
715376|NCT03237013|Study was conducted between February and December 2016. Participants were recruited from an undergraduate research participation website at a large, public American university. A general description of the study's purpose, which specified study inclusion criteria and one's time commitment was provided for potential participants|
715377|NCT03236311|The study was conducted in United States, South Korea, Sweden, Netherlands and Denmark from 12 Oct 2017 to 23 Jul 2018.|A total of 10 participants who met all of the inclusion criteria and none of the exclusion criteria were randomized and enrolled in the study.
715378|NCT03236168||
715379|NCT03235817||
715380|NCT03235726|This was a two parts single and repeat dose escalation study. Part 1 was conducted in healthy volunteers and Part 2 was conducted in participants with moderate chronic obstructive pulmonary disease (COPD).|A total of 52 participants (36 in Part 1 and 16 in Part 2) were enrolled in this study. This study was conducted at a single center in the United Kingdom from 13-July-2017 to 19-June-2018.
715503|NCT03210337||
715504|NCT03210220||
716337|NCT03052764||
728892|NCT01870921||
715381|NCT03235479|The study was conducted at 50 centers in the United States.|A total of 1485 participants were enrolled, of which 1162 participants were randomized to BHV-3000 (rimegepant) 75 milligram (mg) or placebo. A total of 323 participants failed screening mainly due to failure to meet eligibility criteria.The randomization was stratified in a 1:1 ratio based on use of prophylactic migraine medications (yes or no).
715382|NCT03235414||
715383|NCT03235349|The study was conducted at 34 sites in China and South Korea. Eligible participants were chronic hepatitis C (HCV) genotype (GT)1-6-infected adults with compensated cirrhosis with or without HIV co-infection who were HCV treatment-naïve or treatment-experienced with regimens containing interferon (IFN), pegylated IFN, ribavirin, and/or sofosbuvir.|
715384|NCT03235284||
715385|NCT03235115||
715386|NCT03235089||
715387|NCT03235050||
715388|NCT03234465||3 patients were randomized but never received study drug and are excluded from the safety analysis set.
715389|NCT03234374||
715390|NCT03234036|This two-part study assessed the relative bioavailability and food effect of a novel tablet formulation of boosted-GSK2838232 compared to capsule along with safety and pharmacokinetics of repeated once-daily doses of non-boosted GSK2838232. This study was conducted at a single center in the United States.|Participants received GSK2838232 200 milligrams (mg)/ritonavir as capsule or tablet formulation in Part 1 and GSK2838232 500 mg or placebo in Part 2. A total number of 16 participants were enrolled in Part 1 of the study and 10 participants were enrolled in Part 2. In total, 26 participants were enrolled in the study.
715391|NCT03233737||
715392|NCT03233529||
715393|NCT03233438||
715394|NCT03233308||
715395|NCT03233230||A total of 933 participants with rheumatoid arthritis were screened. Out of which, 390 participants were randomized in ratio of 1:1:1:1 to 1 of the 4 treatment groups: Placebo; M2951 25 milligrams (mg) once daily (QD), M2951 75 mg QD and M2951 50 mg twice daily (BID).
715396|NCT03233217|Study participants were enrolled from 15 September 2017 to 26 October 2017 at 2 centers in Japan.|10 participants were randomized 1:1 to receive either QIV-HD by intramuscular (IM) route or QIV-HD by subcutaneous (SC) route (Cohort 1). After review of local and systemic AEs for 7 days post-vaccination in Cohort 1, remaining 165 participants were randomized 1:1:1 to receive QIV-HD by IM route, QIV-HD by SC route, or QIV-SD by SC route (Cohort 2)
715397|NCT03233009|All the participants were enrolled at one center in Brazil.|A total of 46 participants were screened, out of which 3 participants did not meet study criteria, 43 participants were enrolled in the study out of which 3 participants withdrew their consent. Remaining 40 participants were randomized to the study.
715398|NCT03232983||This is an open-label, randomized, crossover, up to 10-hour euglycemic clamp study in which participants were randomized into one of four treatment sequences. Participants received single doses of 15 units of LY900014 on 4 occasions (treatment Periods 1 through 4) with a wash-out period of at least 3 days between study drug administration.
715399|NCT03232892||
715400|NCT03232827|A total of 207 individuals were identified as eligible for study participation. Study personnel contacted the individuals by telephone to schedule their initial visit. 91 were consented and enrolled.|Subjects who were eligible & presented to initial visit 12 hour tobacco abstinent were randomized. Subjects were randomized to 1 of 36 session sequences & completed up to four smoking sessions. 2 subjects were not nicotine abstinent at their initial visit, were rescheduled & lost to follow-up.
715401|NCT03232580|5 patients enrolled single site in US|
715402|NCT03232567|Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects were screened within 28 days of randomization.|60 subjects who met all inclusion and no exclusion criteria and provided written informed consent were enrolled into 3 sequential cohorts of 20 subjects each defined by the vaccine dose (1×10^9, 1×10^10,1×10^11 vp). Within each cohort and its sentinel group, subjects were randomized in a 3:1 ratio to receive 1 intranasal dose of NasoVAX or placebo
715403|NCT03232333||
715404|NCT03231943|This study was conducted to evaluate safety, tolerability and pharmacokinetic (PK) of GSK3640254 in healthy participants at one center in United Kingdom from 19-September-2017 to 09-September-2018|Total 78 participants were enrolled in the study. This was a two part study, Part 1 was single ascending dose (SAD) and Part 2 was multiple ascending dose (MAD).
715405|NCT03231917||
715406|NCT03231800||
715407|NCT03231709|Participants took part in the study at 2 investigative sites in Japan from 18 August 2017 to 4 February 2018.|Participants with a diagnosis of Type 2 Diabetes Mellitus (DM) were enrolled in 1 of 2 crossover arms: trelagliptin 100 mg then alogliptin 25 mg or alogliptin 25 mg then trelagliptin 100 mg.
715408|NCT03231371||
715409|NCT03231345||
715410|NCT03231228||
715411|NCT03230864||Patients who did not fulfil the randomization criteria for the DBT period, were withdrawn from the study after the PC period. Patients who fulfilled the randomization crietria for the DBT period, continued into the DBT period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm.
715412|NCT03229486||
715413|NCT03229252||
715414|NCT03229109||
715415|NCT03228836||
715416|NCT03228433|Participants took part in the study at single site in the United States from 21 July 2017 to 12 May 2018.|Healthy participants were randomized to receive TAK-418 or matching placebo in Cohorts 1 to 5.
715417|NCT03228212|A total of 133 subjects were enrolled into this study. Of the enrolled subjects, 130 were dispensed at least one study lens and 3 subjects failed to meet all eligibility criteria. Of the dispensed subjects 127 completed the study while 3 subjects were discontinued.|
715418|NCT03227861|Out of 97 participants who completed the main study, 80 participants continued into the extension phase and were treated with Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC).|
715419|NCT03227692||
715466|NCT03217175||22 subjects signed the consent form and screened into the study. 5 subjects were randomized and participated in the outpatient run-in period for one arm. Only 2 subjects of those 5 completed the arm. No subjects completed both arms of the study.
715467|NCT03216902||
715468|NCT03216850||
715469|NCT03216746||
715420|NCT03227445|This is a randomized, multi-center, open-label study comparing placebo ELLIPTA with placebo DISKUS + HandiHaler to assess correct inhaler use in participants with Chronic Obstructive Pulmonary Disease (COPD). A total of 17 centers across United States participated in the study.|Out of 240 randomized participants (par), 239 entered the study as 1 par was randomized in error. In order to minimize potential bias the order of placebo devices & order of responses, in preference questionnaire (PQ), was randomized in a crossover design. All par on study received placebo only & participant flow reflects this as the only treatment
715421|NCT03226769||
715422|NCT03226691||
715423|NCT03226392|Participants were recruited from centers in Brazil (8), Bulgaria (4), Canada (3), Colombia (4), Germany (5), Hungary (7), India (5), Israel (5), Italy (4), Peru (6), Republic of Korea (5), Russian Federation (14), Spain (8), United States (36), Vietnam (3).|
715424|NCT03226366||
715425|NCT03226353||
715426|NCT03226275||The study was designed to assess bioequivalence (BE) between a single oral dose of bisoprolol-amlodipine fixed-dose-combination (FDC) tablet and bisoprolol and amlodipine, each given concomitantly as a single dose in fasting or fed state.
715427|NCT03226249|The study opened to accrual on September 6th, 2017 with an accrual goal of 30 patients. The first patient was enrolled onto the study and started treatment on November 9th, 2017. The study closed permanently to further enrollment of participants on March,12th 2019 as the accrual goal was met.|
715428|NCT03226223||
715429|NCT03225599||
715430|NCT03225573||
715431|NCT03225313|ASA I & II patients. 25 patient in each group.|Prospective randomized double blinded controlled clinical trial was done with a total number of 75 patients divided into 3 groups .
715432|NCT03225001||
715433|NCT03224598||
715434|NCT03224390||
715435|NCT03224325|Participants took part in the study at 1 investigative site in the United States from 21-Jul-2017 to 9-Sep-2018.|Healthy volunteers were enrolled in a 1:3 ratio to receive placebo or TAK-831 in 6 cohorts.
715436|NCT03224130||
715437|NCT03223909||
715438|NCT03223662||
715439|NCT03223337|This was a two part study in adults with moderate (Part 1) and potentially mild (Part 2) hepatic impairment and matched, healthy control participants with normal hepatic function. This study was conducted at two centers in the United States of America (USA).|All participants received 6 milligrams (mg) of daprodustat (GSK1278863) as a single oral dose in the fasted state. A total number of 16 participants were enrolled in Part 1 and 21 participants were enrolled in Part 2 of the study. In total 37 participants were enrolled in the study.
715440|NCT03223246||
715441|NCT03222583|This study was conducted at 47 sites in China, South Korea, and Singapore. Eligible participants were non-cirrhotic chronic hepatitis C (HCV) genotype (GT)1-6-infected adults with or without HIV co-infection who were HCV treatment-naïve or treatment-experienced with regimens containing interferon (IFN), pegylated IFN, ribavirin, and/or sofosbuvir.|Randomization was stratified by geographic region, genotype (GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected). Participants were randomized to Arm A or Arm B in the following ratios: China: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3 - 6; South Korea and Singapore: 2:1 for GT1 and 2:1 for GT2.
715442|NCT03222505||
715443|NCT03222427||
715444|NCT03222414||3 participants were randomized, but data was not analyzable on 2 participants. Randomization assignment was not recorded on these 2 participants.
715445|NCT03222141||
715446|NCT03222128|Subjects were screened and enrolled at 51 sites in the US|The As-Treated population was 1074 The Valve-Implanted population was 1069
715447|NCT03222037|A total of 49 subjects were enrolled into this study. Of the enrolled subjects, 43 were dispensed at least one study article. Of the dispensed subjects all 43 completed the study.|
715448|NCT03221764||
715449|NCT03221738||
715450|NCT03221660||
715451|NCT03221192|This was a cross-sectional qualitative study to characterize the participants experience of nasal polyps. Participants were identified via partner recruitment agencies for participation in the Concept Elicitation (CE) or Cognitive Debriefing (CD) interview.|A total of 27 participants with severe, recurrent nasal polyps who underwent at least one nasal polyp surgery in the past 10 years were enrolled in the study. The study was conducted in the United States and Germany.
715452|NCT03220737|This study included healthy volunteers (2 - 17 years) who were not previously immunized against cholera. A total of 574 subjects were screened, of which 24 were screen failures. A total of 550 subjects randomized, of which 471 received study treatment and 433 and 73 completed the main study for treatment and placebo, respectively. Recruitment July 2017-July 2018.|"This study included healthy volunteers (2 - 17 years) who were not previously immunized against cholera. A total of 574 subjects were screened, of which 24 were screen failures. A total of 550 subjects randomized, of which 471 received study treatment and 506 and 62 completed the main and sub studies, respectively. Recruitment July 2017-July 2018.
~The historical control subjects are not included in the protocol enrollment number for PXVX-VC-200-006. They are solely a comparator population."
715453|NCT03220412||
715454|NCT03220230||
715455|NCT03220204||
715456|NCT03220048||
715457|NCT03219723|Participants took part in the study at 58 investigative sites in Japan, from 01 September 2015 to 30 April 2017.|Participants with a historical diagnosis of gastric/duodenal ulcer, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis were enrolled to receive interventions as part of routine medical care. However, participants with gastric MALT lymphoma were not enrolled in the survey.
715458|NCT03219320||
715459|NCT03219294||
715460|NCT03219216||A total of 100 participants were enrolled and received ≥ 1 dose of study drug.
715461|NCT03218592||
715462|NCT03218566||
715463|NCT03218397||
715464|NCT03218163||This study enrolled 1 participant, but the study was terminated before they could be assigned to the intervention, therefore, 0 participants started the study.
715465|NCT03217968||
715470|NCT03216512||5 participants were consented to the study, but failed to meet all inclusion/exclusion criteria
716588|NCT03017937||
715472|NCT03216265|All participants were enrolled at one center in Germany.|A total of 93 participants were screened, out of which 24 did not meet study criteria. Remaining 69 participants were enrolled in the study, out of which 3 did not start the study. 2 were lost to follow-up and 1 due to other reason (not specified).
715473|NCT03216200||
715474|NCT03215901|Study participants were recruited from the population surveillance of the Africa Health Research Institute (AHRI) in Somkhele, South Africa, which served as the sampling frame.|From a pre-determined sample of 835 young adults, 433 young adults were found at home and a recruitment attempt was made. Of these, 430 consented to participate. 3 participants dropped out before completing the baseline survey, were not exposed to the treatment, and were blinded to their randomization status. 427 completed the baseline.
715475|NCT03215758|Participants were recruited from centers in Argentina (20), Germany (12), Hungary (4), Mexico (2), Philippines (4), Slovakia (7), South Africa (5), Turkey (5), United States (29)|
715476|NCT03215706||719 Randomized; 707 Treated; reasons not treated: 1 adverse event unrelated to the study drug, 4 participants withdrew consent, 5 no longer meet study criteria and 2 other reasons.
715477|NCT03214952|Participants took part in the survey at 291 investigative sites in Japan, from 01 March 2016 to 31 October 2018.|Participants with a historical diagnosis of gastric ulcer, duodenal ulcer, and reflux esophagitis were enrolled. Participants received vonoprazan as part of a routine medical care.
715478|NCT03214588|Participants took part in the study at 6 investigative sites in the United States from 08 November 2017 to 27 December 2018.|Participants with a diagnosis of Friedreich Ataxia were randomized in a 2:1:2 ratio to receive TAK-831 75 mg TAK-831 300 mg or TAK-831 placebo-matching tablets twice daily.
715479|NCT03214406||
715480|NCT03214380||The purpose of the Lead-in Period was to titrate basal insulin prior to randomization. Participants were then randomized to receive Insulin lispro (Humalog) or LY900014 in the Treatment Period (Period 2).
715481|NCT03214367|"The study consists of 2 double-blind arms (LY900014 and Insulin Lispro (Humalog)) and one Open-label treatment group (LY900014 Postmeal).
~Double-blind group: The study included 8-week lead-in period followed by a 52-week treatment period.
~Open-label treatment group: The treatment period ended after 26 weeks."|The purpose of the Lead-in Period was to titrate basal insulin prior to randomization. Participants were then randomized to either LY900014 at mealtime, Insulin Lispro (Humalog) at mealtime, or LY900014 administered 20 minutes after the start of a meal (LY900014 Postmeal) in the treatment period (Period 2).
715482|NCT03214224|49 subjects (including 3 patients not completing procedures, 3 controls, and 3 therapists)|
715483|NCT03214094|Participants took part in the survey at 121 investigative sites in Japan, from 01 September 2016 to 28 February 2019.|Participants with a historical diagnosis of gastric or duodenal ulcers were enrolled. Participants received vonoprazan as part of a routine medical care.
715484|NCT03214081|Participants took part in the survey at 122 investigative sites in Japan, from 01 March 2016 to 31 August 2018.|Participants with a historical diagnosis of reflux esophagitis were enrolled. Participants received vonoprazan as part of a routine medical care.
715485|NCT03213626|This was a single arm two stage design. The 1st stage was to have 11 patients and be terminated if 0 responded. The 2nd stage would have a total of 37 patients and if the number responding was <= 2, the combination was to be rejected. The study was terminated prematurely due to no patient benefit at Patient 7.|
715486|NCT03213509|Please note 170 cases were enrolled (ie, babies who suffered from perinatal mortality). Of these 170 cases, there were four sets of twins, both of whom died. This means that there were a total of 166 potential participants to interview via verbal autopsy (we asked for one interview in the case of twins).|Note: Perinatal mortality cases were assigned to intervention or control group based on their assignment during the BetterBirth Trial. This assignment did not impact the verbal autopsy data collection process; all cases underwent the same interview process.
715487|NCT03213405|Recruitment was performed in a single center. Recruitment started on 06.27.17 and ended on 12.04.17.|
715488|NCT03213366||
715489|NCT03212690|This study elucidated the association of the Renin-angiotensin system and right ventricular (RV) function in mechanically ventilated participants. This study was conducted at two centers in France from 11-June-2018 to 08-July-2019. A total of 57 participants were enrolled in this study.|The study was terminated as overall probability of project success was considered low. The study had significant programmatic risks identified with development plan for Recombinant Human Angiotensin Converting Enzyme2 in critical care including participant identification, uncertainty around potential to impact mortality and operational feasibility.
715490|NCT03212638||
715491|NCT03212521|Participants were enrolled at 40 sites in Bulgaria, Canada, France, Germany, Poland, Russian Federation, Spain, United Kingdom, and the United States (including Puerto Rico).|
715492|NCT03212365||
715493|NCT03212326|Patients recruited from hospital inpatient ward and from electrophysiology laboratory procedure suites. Recruitment commenced March 2013, and ended March 2016.|
715494|NCT03212261|Screening and recruitment occurred from August through December 2017. There were a few subjects who expressed interest in discussing participation in January 2018 due to the holidays, which led to their enrollment in January 2018. However, the active recruitment period occurred from August through December 2017.|Individuals who signed consent but who are found to be unable to use the videoconferencing software during the brief test call will be considered ineligible for the study. Two people fell into this category.
715495|NCT03212144|Study terminated at early stage due to poor enrollment|
715496|NCT03211858|The study was conducted at 82 centers in 7 countries. A total of 846 participants were screened between 02 August 2017 and 29 December 2017, of which 249 participants were screen failures. Screen failures were mainly due to glycated hemoglobin A1c (HbA1c) level lesser than (<) 7.0% or greater than (>) 10% at the screening visit.|Randomization was stratified by HbA1c at screening visit (<8%, greater than or equal to [>=] 8%), prior use of NovoLog/NovoRapid (Yes, No), geographical region (Europe, United States [US], Japan) and type 1 or 2 of diabetes mellitus (T1DM/T2DM [US only]). Assigned to arms in 1:1 ratio (SAR341402: NovoLog/NovoRapid).
715497|NCT03211156|Participants were recruited from women who were colonized/infected with Gardnerella vaginalis but have no clinical evidence of Bacterial Vaginosis. Enrollment occurred between 21SEP2017 and 08AUG2019.|
715498|NCT03211117||
716121|NCT03089944||A total of 343 participants were enrolled and received ≥ 1 dose of study drug.
715505|NCT03210155|The only subject was recruited from study flyer in May 2018. Subject met inclusion criteria, provided informed consent and was recruited into the study.|The only subject recruited from study flyer in May 2018. Subject met inclusion criteria, provided informed consent and was recruited into the study.
715506|NCT03209973|70 participants were enrolled at 11 sites in China. The first participant dose date was on 21April2017. Data cut off date for the primary outcome measure was 26Nov2018.|
715507|NCT03209570||
715508|NCT03209518|Participants took part in the survey at 52 investigative sites in Japan, from 18 March 2016 to 10 October 2018.|Participants with a historical diagnosis of premenopausal breast cancer were enrolled. Participants received Leuprorelin as part of routine medical care.
715509|NCT03209492|Participants took part in the study at 61 investigative sites in Japan, from 01 April 2016 to 01 December 2017.|Participants with a historical diagnosis of prostate cancer were enrolled. Participants received interventions as part of routine medical care.
715510|NCT03208933|The study enrolled participants in Russia.|
715511|NCT03208673||
715512|NCT03208192|Partipants were recruited at Moscow Clinical Scientific Center. The first participant was enrolled on Feb 2017 and the last participant was enrolled in April 2020|Of 68 enrolled participants, met inlusion criteria and were randomized.
715513|NCT03208166||
715514|NCT03208088|A total of 96 subjects were enrolled in this study, of which 91 subjects were assigned at least 1 study lens, 5 subjects failed to meet all eligibility criteria. Of the total assigned subjects, 88 completed the study, while 3 were discontinued.|Subjects were randomized to 1 of 10 unique lens sequences.
715515|NCT03207776||
715516|NCT03207763|Participants were enrolled at the Emory Children's Center in Atlanta, Georgia. Enrollment began on July 11, 2017 and all follow up was complete by May 15, 2019.|
715517|NCT03207750|The study was conducted at 48 centers in the United States (US).|"Out of 1280 subjects enrolled in the study, 7 subjects did not receive any study treatment and 1 subject was eliminated from all analyses as there was a deviation in informed consent.
~1272 subjects were vaccinated and included in the Exposed Set, 1148 subjects completed the study."
715518|NCT03207438||We estimated the total sample size prior to accessing the data. However, not every participant consented to have their information used/shared with researchers. Therefore the analyzed sample, consisting of only those who consented, is slightly reduced compared to the sum of the sample sizes reported in the original study reports.
715519|NCT03207399||
715520|NCT03207243|This was a randomized, double-blind, placebo-controlled, parallel-group multicenter study to assess the efficacy, safety and tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of GSK3772847 in participants with moderately severe asthma.|A total of 165 participants with moderately severe asthma were randomized to receive GSK3772847 or placebo.
715521|NCT03207074|All patients attending rapid access clinic, or day surgery for investigation of suspected endometrial cancer were asked to participate in the study. Those needing tissue biopsies for clinical indications, were also asked to undergo a second research biopsy. The research biopsy is analysed by the iKnife.|
715522|NCT03206970|86 participants were enrolled at 13 sites in China. Data cut off date for the primary outcome measure was 15Feb2019.|
715523|NCT03206918|91 participants were enrolled at 11 sites in China. The first participant dose date was on 09Mar2017. Data cut off date for the primary outcome measure was 14Dec2018.|
715524|NCT03206788||
715525|NCT03206216||
715526|NCT03205488|From November 2017 to December 2018, 125 patients were assessed for eligibility. Of those screened, 76 participants were enrolled in the trial.|Of the patients assessed for eligibility, 49 (39%) were excluded. 42 patients did not meet inclusion criteria and 7 declined study participation.
715527|NCT03205371|Study participants were enrolled in South Korea, Mexico, the Russian Federation, and Thailand from 07 November 2016 to 13 June 2018.|A total of 1183 participants were enrolled and randomized in the study.
715528|NCT03205358|Study participants were enrolled from 31 March 2015 to 17 July 2015 at 8 clinic centers in Finland.|A total of 188 participants who met all inclusion and none of the exclusion criteria were randomized and vaccinated in the study.
715529|NCT03205163|The study was conducted in Japan and United States between 28 August 2017 to 12 November 2018.|A total of 16 participants were enrolled, 7 participants to low dose cohort (LDC) and 9 to high dose cohort (HDC).
715530|NCT03204942||140 patients were assessed for primary eligibility using Visual Analogue Scale(VAS).Of which81 only met the inclusion and exclusion criteria. Those 81 were assessed for final eligibility using MRI, CT and bone scan. 69 were included and12 were excluded before randomization due to4 died,4 declined to participate and4 had severe health deterioration
715531|NCT03204643||
715532|NCT03204539|Only 1 participant enrolled, but did not complete study due to early study termination.|
715533|NCT03204279||
715534|NCT03203564|Subjects were recruited from a database of healthy volunteers at CTC and from advertising in media, including social media.|Subjects were screened for eligibility according to study-specific inclusion/exclusion criteria within four weeks prior to start of study treatment (Visit 1; Screening Visit).
715535|NCT03203291||
715536|NCT03202550||Three participants who were enrolled but did not receive the intervention had either chosen not to proceed further with the study or were not able to swallow the study drugs.
715537|NCT03202472|"Dates of recruitment period: Patient consent and enrollment began 9-Aug-2017 and the final surgical procedure was performed 12-Jan-2018.
~Fifty-five patients were accessed for eligibility. Five patients who initially consented for the study but then withdrew prior to intervention because their surgeries were either cancelled or rescheduled"|There are no pre- assignment details to describe
715538|NCT03201900|Participants took part in the study at 38 investigative sites in Japan and Korea. Results are reported based on the primary completion date of 28 Feb 2019. A total of 98 participants were screened, of which 07 were screen failures and 91 entered Treatment Phase. Of these, 89 participants received the study treatment.|Study consisted of 2 main phases: Treatment Phase (consisted of 4 milligram [mg] Treatment Phase [the Titration Period {6 weeks} and the Maintenance Period {26 weeks}] and, for those participants who need a higher dose, the 8 mg Treatment Phase [the Titration Period {4 weeks} and the Maintenance Period {26 weeks}]) and Extension Phase.
716589|NCT03017846||
716590|NCT03017612||
715539|NCT03201419|A total of 71 sites were authorized to recruit subjects for the trial between July 2017 and July 2019. The trial sites that screened subjects to the trial were: 5 in Belgium, 10 in Canada, 5 in Czech Republic, 2 in Germany, 5 in Hungary, 1 in Poland and 43 in the Unites States of America (USA).|A total of 1721 subjects were screened, wherein, 531 met the eligibility criteria and entered the enrichment period. Of these, 302 subjects met the eligibility criteria at Visit (V) 4 (randomization), and were randomized to treatment with FE 201836 (different doses), placebo, or desmopressin. A total of 278 subjects completed the trial.
715540|NCT03200925||
715541|NCT03200912||The populations for this study included the Safety Population, the Per-Protocol Population, and the modified Intent-to-Treat (mITT) population.
715542|NCT03200860||
715543|NCT03200535||
715544|NCT03199911||
715545|NCT03199872||
715546|NCT03199079||
715547|NCT03198884|A retrospective chart review of appoximately 400 HIV+ patients receiving treatment at an urban diverse FQHC was conducted to identify those who were receiving an NRTI-sparing regimen of DRV and DTG.|Subjects included were at least 18 years of age, receiving DRV/r + DTG QD for at least 24 weeks and had laboratory data through 48 weeks of follow up. Those excluded were not taking the study regimen, missed more than five doses of medication over two weeks prior to study visit or if there was missing lab data for 2 or more study time points.
715548|NCT03198767|A total of 116 subjects were screened and 54 subjects were enrolled and randomized, with 48 completing the study. 6 subjects in Part A were discontinued due to a protocol deviation after day 3 dosing (the protein drink provided to subjects was incorrect and included 8% carbohydrate).|
715549|NCT03198754|89 consented, but 16 not enrolled|
715550|NCT03198520||
715551|NCT03198507|This study was conducted between July 2017 and December 2018. A total of 62 centers in the US screened potential subjects and 55 centers randomized subjects into the study.|
715552|NCT03198000||
715553|NCT03197883|All the participants were recruited from one center in Brazil.|A total of 163 participants were screened, out of which 31 did not meet study criteria, 7 had adverse events (AEs), 1 participant was lost to follow-up, 1 withdrew his consent and 23 participants were not randomized in the study due to other reasons (not specified).
715554|NCT03197558||
715555|NCT03197376|Recruitment period: 21 June 2017 to 29 January 2018|Randomization took place only after a subject had satisfied all eligibility criteria. Subjects were randomized in a 2:2:2:3 ratio based on a pre-established randomization scheme.
715556|NCT03197025||Only one participant was enrolled, thus Arm/Group - 2/Arm 2 MTD was not done.
715557|NCT03196635||
715558|NCT03196505||
715559|NCT03196349||
715560|NCT03196232||
715561|NCT03196193||
715562|NCT03195517||
715563|NCT03195010||
715564|NCT03194776||A total of 46 subjects with clinical evidence of PAD and intermittent claudication were enrolled and randomized in this study.
715565|NCT03194698||
715566|NCT03194503||
715567|NCT03194490||
715568|NCT03194464|Participants identified by the VA Brain Rehabilitation Research Center (BRRC) screening and recruitment core enrolled between 2/1/2016 - 5/21/2018.|
715569|NCT03194373||One enrolled patient withdrew prior to starting study treatment.
715570|NCT03194334||
715571|NCT03194217||
715572|NCT03193593||
715573|NCT03193047|170 participants were screened; out of 170, 59 participants were randomized. One participant never received study medication and withdrew from the study due to the Sponsor's decision.|
715574|NCT03193021||
715575|NCT03192904||
715576|NCT03192826||
715577|NCT03192488|Subjects were recruited by direct email to the administrators of the Indiana University ROTC program. It was made clear that participation of cadets was voluntary in nature and was not be a requirement of ROTC duties. Active recruitment took place from 08/2017 to 03/2018.|Enrolled participants were excluded prior to arm/group assignment if they had abnormal pulmonary function, or voluntarily discontinued with study procedures after completing a graded maximal exercise test and familiarization trial of exercise performance tests on a cycle ergometer. Two subjects withdrew prior to initial group assignments.
715578|NCT03192475||
715579|NCT03192306||
715580|NCT03192137||
715581|NCT03191552|Among the 36 children evaluated for recruitment, 26 of them met the inclusion criteria. There were two drop-outs throughout the follow-up period. Finally, data from 24 children were analyzed.|"Not meeting inclusion criteria (n=10)
~Mixed CP n=2
~Undergone surgery in past 6 months n=2
~BTX-A injection in past 3 months n=2
~Who do not understand and execute given instructions, severe CP n=4"
715582|NCT03191396|"The trial was conducted at 77 sites in 11 countries as follows (number of sites that screened subjects/ number of sites that randomised subjects):
~Bulgaria (9/ 9); Czech Republic (5/ 5); Finland (8/ 8); France (8/ 8); Hungary (8/ 8); Italy (4/ 4); Poland (3/ 3); Slovenia (4/ 4); Spain (5/ 5); Sweden (6/ 6); United Kingdom (17/ 17)"|After screening, subjects were required to continue their oral anti-diabetic drug (OAD) pre-trial background medication (i.e. metformin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulphonyl ureas, or combinations of these) throughout the entire trial.
715583|NCT03190993||
715584|NCT03190369|The study was conducted at 21 sites in China from 21 August 2017 to 28 January 2019. A total of 524 participants were screened, of which, 84 participants were screen failures. Screen failures were mainly due to inclusion criteria not met.|A total of 440 participants were enrolled and randomized in the study. Assignment to arms was done centrally using an interactive voice response system/interactive web response system (IVRS/IWRS) in 1:1 ratio (Placebo: Hylan G-F 20).
715585|NCT03190213||
715586|NCT03190083||
715587|NCT03190005||
715588|NCT03189745||Participants who received either MenACWY-TT (NIMENRIX) or Mencevax ACWY vaccine in study 109069 (NCT00464815) were administered a MenACWY-TT booster vaccination in this study and evaluated for immunogenicity, reactogenicity and safety parameters.
715627|NCT03180645|All the participants were enrolled at one center in Germany.|A total of 86 participants were screened, out of which 14 did not meet study criteria, remaining 72 participants were randomized to the study.
715589|NCT03189589|The study was conducted at a single center in the United Kingdom from 15-June-2017 to 24-July-2017.|A total of 19 participants were screened for this study, of which 7 participants were screen failures and 12 participants were randomized to treatment. The reasons for screen failure were: did not meet inclusion/exclusion criteria (6 participants) and withdrawal by participant (1 participant).
715590|NCT03189134||
715591|NCT03188536|Participants took part in the study at 30 investigative sites in Spain from 26 July 2017 to 30 January 2019.|Participants with a diagnosis of multiple myeloma with symptomatic relapse and/or refractory disease were observed to collect the retrospective data on Day 1.
715592|NCT03188523||Twelve participants infected with Human Immunodeficiency Virus 1 (HIV-1) were enrolled into Panels A and B. Due to an earlier than anticipated achievement of the study primary study objectives, Panels C and D were not conducted and no participants were enrolled in these panels.
715593|NCT03188263||
715594|NCT03188120|This was a non-interventional, observational study to collect new real world data (i.e., data under routine medical practice) on safety and effectiveness of Spiriva Respimat treatment in patients.|All participants were screened for eligibility to participate in trial. They attended specialist sites to ensure that they (the participants) met all implemented inclusion/exclusion criteria. Participants were not to be entered to trial if any of the specific entry criteria was violated.
715595|NCT03188055||We received 233 survey responses for the anonymous Moral Distress Survey (MDS). As these pre/post surveys were given anonymously, it was not possible to determine the total number of participants as some participants could have completed both pre and post surveys.
715596|NCT03187756||
715597|NCT03187678|Twenty-two patients treated with Uptravi for pulmonary arterial hypertension (PAH) were screened; 20 of them were enrolled in the study.|
715598|NCT03187301|Patients with Parkinson's disease (PD) complicated by motor fluctuations ('OFF' episodes) were recruited in 13 study sites in Italy and the United States, starting April 2017. The study was completed in December 2017. Approval was obtained from the Enrollment Adjudication Committee and Sponsor prior to enrollment of each patient.|Dose Titration Phase: individual responses to single doses of APL 130277 were evaluated at 5 mg increments up to 40 mg and then 10 mg increments up to 60 mg until a full 'ON' was achieved. If tolerated, patients were titrated to a supratherapeutic dose (up to 60 mg) which was 1 or 2 levels above the initial dose producing an 'ON' response.
715599|NCT03187197|This non-interventional study enrolled patients in Taiwan with a previous Vitamin K Antagonist (VKA) therapy, followed by switching to Pradaxa® (one of the novel oral anticoagulants (NOACs)) or patients being newly diagnosed with Non-Valvular Atrial Fibrillation (NVAF) and initiated on Pradaxa® or VKA.|Data was collected from approximately 20 medical centers or regional hospitals in Taiwan where Pradaxa® is taken as the prescription of stroke prophylaxis (or prevention) in Atrial Fibrillation (AF). Data was collected between June 23, 2017 and Jan 11, 2019. 10 enrolled participants were removed due to screening failures before entering the study.
715600|NCT03187002|All recruitment occurred at the Planned Parenthood site.|
715601|NCT03186781|Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.|
715602|NCT03186677||There were 11 unique subjects who completed the study; 2 failed screening. Of the 5 subjects in Cohort 4, 1 subject previously participated in Cohort 1 and 2 subjects in Cohort 2. Of the 2 subjects in Cohort 5, 2 subjects previously participated in Cohort 4. As a result, the Safety Analysis Set included 16 subjects. Cohorts were conducted in numerical order.
715603|NCT03185481||
715604|NCT03185455||
715605|NCT03185182|Patients were recruited continously in this study. Five patients were recruited, all at the Urological Clinic at Skåne University Hospital, Jan Waldenströms gata 7, 205 02 Malmö, Sweden. The first patient was recruited 2017-07-14 and the last patient was recruited at 2018-05-23.|Patients were recruited continously in this study. Screening critera: suspected dissiminated renal cancer, age 18-70. Five patients were screened for the study and all five patients were considered suitable for enrollment.
715606|NCT03185065||
715607|NCT03184987|This study evaluated long-term safety of fixed dose combination therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate (FF/UMEC/VI) in Japanese participants with asthma. The study was conducted across multiple centers in Japan.|A total of 114 participants were screened, of which 1 failed screening and 2 participants were run-in failures and 111 participants received study treatment.
715608|NCT03184701||
715609|NCT03184519||
715610|NCT03184441|Recruitment was from 3 study sites (i.e. Neonatal Intensive Care Units). 6/30/16-7/30/16.|
715611|NCT03184428|Eyes of patients who underwent a cataract surgery in the Department of Ophthalmology in Neubrandenburg between September 2009 and December 2013 and had an L313 MICS lens implanted.|"The following reasons led to an exclusion of participants:
~intraoperative posterior capsule rupture
~Distance between place of residence and place of investigation >50 km
~Exchange of the intraocular lens
~Practice closure of the supervising ophthalmologist
~no entry in any established doctor's medical system
~no follow-up"
715612|NCT03184077||
715613|NCT03183869||
715614|NCT03183518|All participants were enrolled at one center in Brazil.|A total of 49 participants were screened, out of which 1 participant did not meet study criteria. Remaining 48 participants were enrolled in the study, out of which 12 participants withdrew their consent before randomization.
715615|NCT03183063||
715616|NCT03182933||Study aimed to obtain 70 patients to account for dropout, however was sufficiently powered if 60 patients enrolled. Study was terminated after 64th patient due to surgeon preferences.
715617|NCT03182920||
715618|NCT03182738||
715619|NCT03182582||
715620|NCT03181724||
715621|NCT03181594||
715622|NCT03181503|The study was conducted at 16 sites in 4 countries.|A total of 100 participants were screened, out of which 70 participants were randomized and treated (36 participants in Placebo and 34 participants in Nemolizumab group). Total 60 participants completed the study.
715623|NCT03181451||
715624|NCT03181308||
715625|NCT03181009||
715626|NCT03180801||An excess number of subjects were vaccinated to ensure 123 subjects were able to complete the quarantine period . Any subject that dropped out after vaccination but before inoculation with the challenge virus was replaced with another vaccinated subject.
715628|NCT03180619|Participants were enrolled at study sites in Asia Pacific, North America, and Europe. The first participant was screened on 29 June 2017. The last Week 48 study visit occurred on 20 Sep 2019.|147 participants were screened.
715629|NCT03180515||
715630|NCT03180489||
715631|NCT03180385||"Informed consent was obtained for 15 participants. However, the reason there are only 2 participants listed under total started in participant flow is because these were the only participants who were actually randomized. The other 13 participants were extubated and did not need BiPAP/NAVA. They were not randomized and were excluded."
715632|NCT03180138||
715633|NCT03179891|Planned enrollment was 40 adult male and female subjects with a clinical diagnosis of epilepsy requiring admission to an epilepsy monitoring unit, a general clinical research center, or similar facility for evaluation of seizures. A minimum of 30 subjects was expected to complete the study.|A total of 35 subjects were enrolled to receive a 12.5-mg dose of study drug during both the interictal and the ictal/peri-ictal period which occurred in either order as determined by seizure occurrence.
715634|NCT03179345||"A total of 32 healthy subjects enrolled in this crossover study. Each subject was randomly assigned to 1 out of 4 treatment sequences.
~Abbreviations:
~Gral = Gralise®; Neur = Neurontin®; Lyr = Lyrica®; Plbo = Placebo."
715635|NCT03179319||
715636|NCT03178942|Two hundred fifty-four (254) patients were randomized to study products. Thirteen (13) sites randomized patients into the study.The first patient was enrolled on 06/14/2017 and the last patient completed was on 10/30/2017. The time from first patient enrolled until last patient completed was approximately four months.|All eligible patients were randomized at visit 1 and received the study product with instructions for dosing at home.
715637|NCT03178851||
715638|NCT03178344||
715639|NCT03178266||
715640|NCT03178045||
715641|NCT03177798|Cross-over design, eleven individuals receive both treatments, Icatibant and placbo|
715642|NCT03177603|This phase 2a, open-label, dose-escalation study comprised of 4 cohorts. Participants received GSK2586881 by single intravenous (IV) infusion at following doses: 0.1 milligram per kilogram (mg/kg) or 0.2 mg/kg or 0.4 mg/kg or 0.8 mg/kg.|A total of 31 participants were screened and of them 7 participants were screen failures and one withdrew consent before dosing. Hence, a total of 23 participants received study treatment. This study was conducted at 4 centers in Germany, 2 centers in Spain, and 2 centers in the United States.
715643|NCT03177395|Studied period: 05 June 2017 to 08 August 2018 Study centres: Edinburgh Clinical Trials Unit (ECTU) The Emergency Medicine Research Group Edinburgh (EMERGE)|Adults within 24 h of a paracetamol overdose that required NAC. Within each of 3 sequential cohorts, participants were randomly assigned, with concealed allocation, to NAC and a single intravenous calmangafodipir dose (n=6/dose) or NAC alone (n=2). Calmangafodipir doses were 2, 5, or 10 μmol/kg. Participants, study and clinical teams not blinded
715644|NCT03176654||
715645|NCT03176407|Patients presenting to the emergency department with acute UGIB were screened for eligibility. Inclusion criteria were symptoms suggestive of UGIB defined as hematemesis, coffee ground emesis or melena (at least one of three).|
715646|NCT03176238||Three hundred eleven participants were screened and 235 enrolled in Asian and non-Asian countries. Primary reason for discontinuation was presented.
715647|NCT03175562|All participants were enrolled at one center in Brazil.|A total of 294 participants were screened,out of which 240 participants were randomized and 54 participants were not randomized. Out of 54 participants, 22 participants did not meet study criteria, 5 participants were lost to follow-up, 26 participants withdrew their consent, 1 participant was not randomized for other reasons (not specified).
715648|NCT03175172||
715649|NCT03175120|The trial was conducted at 40 sites in China.|Participants were randomised in a 2:1 manner to receive either IDegLira or IDeg in combination with metformin.
715650|NCT03174366||
715651|NCT03174158||
715652|NCT03174132||
715653|NCT03173170|Participants took part in the study at 1 investigative site in United States from 31 May 2017 to 24 July 2017.|Healthy participants were enrolled in this single sequence 2-period crossover study to receive TAK-954 0.2 milligram (mg) in Intervention Period 1 followed by itraconazole 200 mg + TAK-954 0.2 mg in Intervention Period 2.
715654|NCT03172702|Japanese patients with hyperkalemia were recruited to this open-label, single-arm study with a flexible dosing regimen conducted in 44 study centers in Japan. First patient enrolled in September 2017; last patient completed in July 2019.|For inclusion, patients were required to have 2 consecutive iSTAT (portable blood analyzer) potassium values, measured 60 minutes apart, both ≥5.1 millimole per liter (mmol/L) and measured within 1 day before the first dose of sodium zirconium cyclosilicate (ZS) on Correction Phase (CP) Day 1.
715655|NCT03172520||
715656|NCT03172494|The trial was conducted at 38 sites in China mainland.|Participants were randomised in a 2:1:1 manner to receive insulin degludec/liraglutide, insulin degludec or liraglutide in combination with metformin.
715657|NCT03172481||
715658|NCT03172364|All the participants were enrolled from one center in Campinas, Sao Paulo, Brazil.|A total of 190 participants were screened for the study, out of which 122 participants were enrolled and 68 participants were not eligible to meet study criteria. Out of 122 enrolled participants, 113 were randomized. Out of 77 nonrandomized participants, 73 did not meet the study criteria, 1 had an adverse event (AE), and 3 were lost to follow-up.
715659|NCT03172130||
715660|NCT03171415||Study was designed to enroll 32 subjects. In practice, 33 subjects were enrolled into the study. In cohort 3, one subject that was injected with plcebo was lost to follow up 3 days following injection. Therefore, an additional subject was enrolled and injected with placebo but he also was lost to follow up, 7 days following injection.
715661|NCT03171051||
715662|NCT03170609||
715663|NCT03170544|This was a 4-part study, participants received MK-1092 or glargine: Part 1 - healthy adult participants; Part 2, healthy adult participants received MK-1092 and also insulin lispro (Humalog®); Part 3 - adult participants with Type 1 diabetes mellitus; Part 4 had 3 periods (Periods 1, 2, and 3), participants with Type 2 diabetes mellitus.|
715723|NCT03159468||All enrolled participants were assigned to one of the six arms.
715724|NCT03159299||
715725|NCT03159260||
715726|NCT03159143||
715727|NCT03159091||
715664|NCT03170271|Patients with severe uncontrolled asthma and peripheral blood eosinophil counts of ≥ 150 cells/microliter (μL) were recruited to 221 centers in 14 countries. Patients were randomized in a 2:1 ratio to receive benralizumab or matched placebo for 24 weeks. Results are reported for the double-blind period of the study (data cut-off: 12 Sep 2019).|Severe eosinophilic patients were to have had ≥ 2 asthma exacerbations while on maintenance inhaled corticosteroids (ICS) plus another asthma controller that required treatment with systemic corticosteroids in the 12 months prior to enrolment. Patients continued to receive their standard of care asthma therapy throughout the study period.
715665|NCT03170232|This study was originally designed for 52 weeks of treatment in participants with mild to moderate chronic obstructive pulmonary disease (COPD); however, the study was terminated early due to a change in the benefit-risk ratio of danirixin hydrogen bromide (DNX HBr).|A total of 86 participants were screened, of them, 54 participants were randomized in a ratio of 1:1 to receive either placebo or 35 milligrams (mg) DNX HBr. Due to early termination of the study, no participants completed the study.
715666|NCT03170219||
715667|NCT03170193|This study was conducted at a single center in the United States. Participants were enrolled from 15 May 2017 to 18 September 2017.|Participants were enrolled into one of six dose cohorts. Within each cohort participants were randomized in a ratio of 3:1 to receive AMG 529 or placebo.
715668|NCT03170154|Subjects were recruited at 16 investigative sites located in the United States.|Of the 376 enrolled, 26 subjects did exit the study as screen failures. This reporting group (350) includes all subjects with attempted implantation with the IOL (successful or aborted after contact with the eye).
715669|NCT03169816||60 patients were enrolled in the trial but of these 49 patients were randomized to one of the treatment arms.
715670|NCT03169530|103 subjects provided signed consent, 32 subjects were randomized. The additional 71 subjects were in the screening or in the run-in stage of the trial at the time of study cessation.|103 subjects provided signed consent, 32 subjects were randomized. The additional 71 subjects were in the screening or run-in stages of the trial at the time of study cessation.
715671|NCT03169244||
715672|NCT03169153|Subjects were recruited from 1 study center located in the United Kingdom.|Of the 114 enrolled, 29 subjects were exited prior to randomization. An additional 4 subjects discontinued after randomization but prior to exposure. This reporting group includes all randomized and exposed subjects (81).
715673|NCT03169062||
715674|NCT03168919|"Recruitment period: 10/2016 through 3/2018
~Location: The subjects were identified from the hospital during the admission for resection of the tumor. They were recruited from the clinic of the radiation oncologists and/or neurosurgeons."|Subject #2: Voluntary withdrawal. Subject #5: Voluntary withdrawal.
715675|NCT03168906||
715676|NCT03168841||
715677|NCT03168542|A total of 23 subjects were enrolled into this study. Of the enrolled subjects 21 were dispensed a study lens and 2 subjects failed to meet the eligibility criteria. Of the dispensed subjects all 21 completed the study.|This was a non-randomized study. The JJVC fitting guide, subjects responses and eye car practitioner options dictated which study lens the subject was to be fit with. Lens type and lens sequence are not experimental design factors. The first lens pair (Right/Left) on eye was the same lens pair (Right/Left) the subject ended with.
715678|NCT03168425||
715679|NCT03168308||
715680|NCT03168295||Diabetic and non-diabetic subjects were assigned to both interventions after randomization, either dapagliflozin first with placebo second, or placebo first and then dapagliflozin next.
715681|NCT03168022||
715682|NCT03167541|This was a single-centre study conducted in United Kingdom.|Total 32 subjects were screened. Of these, 6 subjects were screen failures, 2 were surplus to requirement, 6 were reserve subjects. Subjects randomized were 18.
715683|NCT03167151|Initially, the plan was to recruit the 6 participants for the safety run-in phase of the study within 6 months. 9 patients, of which 6 were evaluable, were recruited at the Oxford Churchill Hospital site from 02 Mar 2018 until 31 Jan 2019. Due to the issues with slow recruitment, the steering committee decided to end recruitment on 31 Jan 2019|9 participants were recruited onto the study. However, of the 9 participants, 2 were found to have no tumour present during their surgery and were therefore no longer eligible. A further 1 participant withdrew their consent after they had been recruited. Thus of 9 participants only 6 were eligible for analysis.
715684|NCT03166735|This study is a multi-centre, double-blind, parallel-group, randomised, placebo-controlled phase IIa study to investigate safety, tolerability, pharmacodynamics, and pharmacokinetics of different doses of orally administered BI 1467335 (for 12-weeks) compared to placebo in patients with clinical evidence of Non-alcoholic steato-hepatitis (NASH).|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
715685|NCT03166618||Up to 189 subjects were planned; 1 subject was enrolled but did not receive treatment.
715686|NCT03166215|Participants took part in the study at 10 investigative sites in the United States from 17 August 2017 to 19 September 2018.|Participants with a diagnosis of developmental and/or epileptic encephalopathies were enrolled to receive TAK-935 or placebo in Part 1 [Double Blind Treatment Period (TP)] and Part 2 (Open Label TP).
715687|NCT03166124||This is a 2-period, crossover study, up to 10-hour euglycemic clamp in which participants were randomized to 1 of 2 treatment sequences: LY900014 in Period 1 switching to Humalog period 2 or Humalog in Period 1 switching to LY900014 in Period 2. A washout period of 3 to 15 days occurred between study drug administration.
715688|NCT03165981||
715689|NCT03165955||A total of 31 subjects were screened; 3 subjects were screen failures and were not included in the analysis
715690|NCT03165916||146 pts enrolled in study. 1 pt w/drew consent prior to randomization. 30 pts were inappropriate candidates & weren't randomized. 115 pts were randomized. 1 pt's clinical course required a second procedure & they were randomized twice. Initially the pt randomized to not receive a stent & later to receive a stent, there were 116 interventions.
715763|NCT03149887|54 patients recruited at time of presentation for surgery. These 54 received the injection of either liposomal bupivacaine (experimental group) or normal saline (control group).|
716193|NCT03075644|The trial was conducted at 12 sites in Japan.|Participants were randomised in a 3:1 manner to receive either somapacitan or Norditropin®.
715691|NCT03165747|Participants were recruited at Emory University Hospital in Atlanta, Georgia, USA. Enrollment began on October 1, 2017 and all study activity stopped on March 23, 2019.|35 individuals consented to participate. The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.
715692|NCT03165617|Subjects were enrolled over 3 seasons, starting in SH 2017, followed by NH 2017-2018 and NH 2018-2019. Recruitment was conducted in 8 countries over these 3 seasons: Australia, Philippines and Thailand (Season 1); Estonia and Finland i(Season 2); and Estonia, Finland, Lithuania, Poland and Spain (Season 3)|
715693|NCT03165175||
715694|NCT03165110|17 March 2017 - 05 May 2017 AMCR Institute, Escondido CA|
715695|NCT03165058||
715696|NCT03165045|Chronic obstructive pulmonary disease patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks in routine clinical practice|All subjects were screened for eligibility to participate in trial. Subjects attended specialist site to ensure that they (the subjects) met all implemented inclusion/exclusion criteria.
715697|NCT03164629||
715698|NCT03164551||
715699|NCT03163758|Acute ischemic stroke inpatients from the department of Neurology in Peking Union Medical College Hospital were enrolled.|Ten participants were excluded from the study because they didn't meet the inclusion criteria.
715700|NCT03163342||
715701|NCT03163303||Participants who completed the baseline assessment were randomized to the STAND intervention or Tobacco Status Project (TSP) control conditions 1:1 using blocked random assignment sequence generated by the biostatistician. Randomization was stratified by 2 variables known to be related to outcomes: daily smoking status and readiness to quit smoking
715702|NCT03163134|All adult patients undergoing endoscopic endonasal approach (EEA) at the Center for Cranial Base Surgery of the University of Pittsburgh Medical Center from February 2011 to April 2015 were evaluated for enrollment.|
715703|NCT03163017||
715704|NCT03162796|A total of 383 participants were enrolled. Among them, 381 participants received at least one dose of study drug (126 in placebo group, 127 in guselkumab 100 mg q8w group and 128 in guselkumab 100 mg q4w group). One participant was randomized to guselkumab 100 mg q8w but not treated.|One participant was accidentally randomized before completion of screening assessments. Subsequently, this participant screen failed and was later re-screened and randomized using a new participant number.Therefore, this participant was counted twice in the number of participants enrolled, but only once in the number of participants randomized.
715705|NCT03162614||
715706|NCT03162458||
715707|NCT03162354|Participating PICUs were stratified based on projected patient volumes, matched into pairs, and allocated randomly to intervention (n=4) or control (n=4) conditions. Eligible participants were acutely head injured patients <3 years admitted for intensive care (excluding MVA victims and patients with pre-existing brain abnormalities). Prospective data capture at all 8 participating PICUs began 1 August 2017 and ended 31 March 2020. For patients, the study was strictly observational.|All eligible patients were included in the analysis.
715708|NCT03162328|84 participants across 7 sites were screened for eligibility for this study. Recruitment was open April 2017 through November 2017.|Of the 84 participants screened, 63 were found to be eligible,however 1 eligible participant withdrew at the randomization visit, but prior to randomization. 1 participant withdrew after being randomized. 1 participant did not complete all study visits, but had enough device data to be included in the analysis.
715709|NCT03162055|This study was conducted in 110 centers in 7 countries (Russia, Bulgaria, Ukraine, United States of America, Canada, Hungary and France) between 25 May 2017 and 04 May 2018. Participants with moderate to very severe chronic obstructive pulmonary disease (COPD) were recruited in this study.|The study had a screening period, followed by a 24-week double-blind and double-dummy treatment period. A total of 1445 participants were screened. Of which, 1119 participants were enrolled and randomized to study treatment.
715710|NCT03161964||
715711|NCT03161938||
715712|NCT03161405|Participants took part in the study at 1 investigative site in the United States from 05 June 2017 to 10 July 2017.|Healthy participants were enrolled in single sequence 2-period crossover study to receive TAK-906 maleate 25 milligram (mg) in First Intervention Period followed by Itraconazole 200 mg along with TAK-906 maleate 25 mg in Second Intervention Period.
715713|NCT03161327|This study recruited patients from various clinics presenting for appointments not necessarily related to PAD. Patients were asked to complete a screening questionnaire. 1791 patients completed the questionnaire. Patients giving any yes responses were asked if they wanted to participate in the study.|Of the 1791 patients who completed the survey, 238 enrolled in the study (gave consent and completed digital ABI screening).
715714|NCT03160898|Patients with familial or sporadic ALS were enrolled at 65 sites in Australia, Canada, Ireland, Netherlands, Spain, and the United States. The first patient was screened on 16 August 2017 and the last patient completed on 07 March 2019.|Eligible patients were male or female, ≥18 - ≤80 years of age, with familial or sporadic ALS diagnosed for ≤24 months. At screening, patients were to have upright slow vial capacity (SVC) ≥60% of predicted; must have been able to swallow tablets, perform reproducible pulmonary function tests; have normal lab tests; and have a caregiver (if needed).
715715|NCT03160885||The screening period was 2 and 6 weeks and included 1 or 2 visits. The exact duration depended on the wash-out period defined by the exclusion criteria. If no wash-out or only a 2-week wash-out was required, screening Visits 1 and 2 were combined. Eligibility was assessed at the (first) screening visit and on Day 0 prior to randomization.
715716|NCT03160716||
715717|NCT03160703|Participants were recruited from one center in Canada.|A total of 225 participants were screened, of which 220 participants were enrolled and randomized in the study. A total of 5 participants were not randomized in study as 3 participants did not meet study criteria, and 2 withdrew their consent.
715718|NCT03160573|United Health Resources Group (UHRG) was responsible for recruitment using advertising and volunteers from their website. All patients were recruited at a single UHRG site (7721 S. Painter Ave, Whittier, CA 90602)|No significant events prior to assignment to an arm.
715719|NCT03160170||
715720|NCT03160027||
715721|NCT03159624||
715722|NCT03159611||
715917|NCT03123614||
715728|NCT03158688|This study was conducted at 102 centers in Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, France, Greece, Hungary, Japan, Poland, Romania, Russia, South Korea, Spain, Taiwan, Turkey, United Kingdom, and United States. 569 subjects were screened and 466 were enrolled.|Participants were randomized in 1:2 ratio to arms KD vs. KdD after being stratified by 1) International Staging System (ISS) stage (Stage 1-2 vs Stage 3) at screening, 2) prior proteasome inhibitor exposure (yes/no), 3) number of prior lines of therapy (1 vs ≥ 2), and 4) prior cluster differentiation antigen 38 (CD38) antibody therapy (yes/no).
715729|NCT03158311|Participants took part in 166 investigative sites in 20 countries from 05 Feb 2018 to 19 Jul 2019.|A total of 1917 participants were screened. A 2 week run-in phase preceded the randomized treatment phase of the study. 1821 participants entered the run-in phase. Those participants who met the inclusion criteria entered the randomized treatment phase. Participants were randomized with a randomization ratio of 1:1:1 to three treatment arms.
715730|NCT03158285||A total of 741 participants were randomized and 739 participants received at least one dose of study drug: 246 in placebo group, 248 in guselkumab 100 mg q8w group, and 245 in guselkumab 100 mg q4w group. Two participants were randomized in error and were never treated. Participant flow is reported for treatment discontinuation up to Week 48.
715731|NCT03158272||19 participants entered the treatment period, and 19 were treated.
715732|NCT03158220||
715733|NCT03158038|The study was conducted from 30 May 2017 to 14 Dec 2017 at 2 sites in the United States of America (USA).|A total of 300 participants were randomized and participated in the study.
715734|NCT03158012||
715735|NCT03157583|All the participants were enrolled at one center in Germany.|Total of 9 participants were screened for the study out of which 1 participant did not meet the study criteria. Remaining 8 participants were randomized in the study.
715736|NCT03157531||
715737|NCT03157232||
715738|NCT03156543||
715739|NCT03155269|Participants were recruited from one center in India.|A total of 117 participates were screened, out of which 114 participants were enrolled and allocated to a randomized treatment in the study (57 participants in each group), and 3 participants were not randomized due to withdrawl of consent.
715740|NCT03155178||"This is a randomized, paired-comparisons design where each subject will receive two of the planned treatments, one on the left side of body and one on the right.
~Each subject provides 2 abdomen test sites, left or right, and 2 inguen test sites, left or right. Therefore 69 subjects provide 276 potential test sites."
715741|NCT03154333||
715742|NCT03154086|This was a two-part study. Part A was a single dose escalating and Part B was a repeat dose escalating. Participants participated in either Part A or Part B of the study. This was a single center study, conducted at one site in Australia.|A total number of 28 participants were enrolled in Part A and 40 participants were enrolled in Part B of the study. Participants in Part A, participated in one of the 3 Cohorts in Part A and Part B participants participated in one of the 5 Cohorts in Part B.
715743|NCT03154047||
715744|NCT03153956||
715745|NCT03152591|This study was conducted in 5 centers in 2 countries: Germany (3), and USA (2).|Participants were randomized in the ratio of 1:1 to receive either LIK066 50 mg tid or placebo for 14 days and morning dose on Day 15.
715746|NCT03152552|Patients were randomized in a 1:1:2:2:2 ratio to one of 5 regimens (LIK066 2.5mg, 10mg, 50 mg, EMPA 25mg, Pbo) at Visit 201 (randomization) with a plan to be treated for 36 weeks.|A placebo run-in period (Epoch 2) running up to 2 weeks before randomization was used to assess eligibility
715747|NCT03152526||
715748|NCT03152136||
715749|NCT03152110||
715750|NCT03152019||
715751|NCT03151551|Per protocol and statistical analysis plan (SAP), the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.|Open-Label Treatment Period from Week 0 to Week 52 inclusive followed by Post-Treatment Follow-Up Period of up to a minimum of 12 weeks.
715752|NCT03151265||
715753|NCT03151226||
715754|NCT03151148|Recruitment of patients with active atopic dermatitis took place between 20 September 2017 through 24 April 2019 at 2 clinical centers in the US: National Jewish Health: Division of Pediatric Allergy and Clinical Immunology and University of California - San Diego|Screened S. aureus positive participants requiring medication/therapy washout of ≤14 days to meet inclusion/exclusion criteria were randomized within 14 days of screening. Screened S. aureus positive participants requiring medication/therapy washout > 14 days, completed a Repeat Culture Visit after a washout, to confirm S. aureus colonization.
715755|NCT03150758||
715756|NCT03150719||A total of 98 participants were randomized: 47 in placebo group and 51 in tezacaftor (TEZ)/ivacaftor (IVA) group. One participant in TEZ/IVA group did not receive any study drug.
715757|NCT03150485|A total of 23 subjects were enrolled into this study. Of the enrolled subjects all 23 were dispensed a study lens. Of the dispensed subjects 22 completed the study while 1 subjects was discontinued.|This was a non-randomized study. The JJVC fitting guide, subjects responses and eye care practitioner opinions dictated which study lens the subject was to be fit with. Lens type and lens sequence are not experimental design factors.
715758|NCT03150199||In order to meet our goal of having 60 participants complete the intervention, we recruited 63 participants in order to account for 3 participants who were Lost to Follow-Up.
715759|NCT03150160||All randomized patients (1). Note: No patients were randomized to the Simbrinza + Travatan arm.
715760|NCT03150108|The study was conducted at a single center in United States between 19 April 2017 (first participant first visit) and 26 Jun 2017 (last participant last visit).|A total of 24 participants (12 non-Hispanic healthy volunteer Caucasian participants and 12 healthy Japanese participants) were enrolled and randomized to study treatment.
715761|NCT03150082|This was an open-label, randomized, single-dose, two-period cross-over study to evaluate bioequivalence of GR37547 ciprofloxacin 500 milligrams (mg) test product versus ciprofloxacin 500 mg reference product in healthy adult participants under fasting conditions. Participants were enrolled at a single center in South Africa.|Participants received treatment in one of the two sequences; Treatment A (GR37547) followed by Treatment B (ciprofloxacin reference) or vice versa in each of the treatment period 1 and 2. A total number of 26 participants were randomized.
715762|NCT03149991||
715958|NCT03117140||
715764|NCT03149848|A total of 15 participants were enrolled from one center in the United Kingdom. The study was conducted from 06 June 2017 to 07 September 2017.|A total of 26 participants were screened for the study. Of these, 6 participants did not meet the inclusion/exclusion criteria and 5 participants (reserved participants) were eligible however they did not participate in the study. Therefore, 15 participants were enrolled and received at least one dose of study medication.
715765|NCT03149172||25 subjects were screened. However, only 21 subjects were enrolled. 4 patients didn't participate the study.
715766|NCT03149055||
715767|NCT03149042||
715768|NCT03148756||
715769|NCT03148691||
715770|NCT03148470||
715771|NCT03148262|A total of 63 subjects consented for the study. Four subjects disqualified.|Four subjects disqualified due to additional procedure, induction without propofol or using fentanyl.
715772|NCT03148236||
715773|NCT03148067||
715774|NCT03147690||
715775|NCT03147248|Participants recruited from 21 study centers in 8 countries for Part 1. Participants recruited from 76 study centers (including 1 good clinical practice [GCP] noncompliant study center) in 12 countries for Part 2. The study was divided into 2 parts (Part 1 and Part 2). Thus, the patients from Part 2 were newly enrolled/randomized only for Part 2.|For Part 1, a total of 90 patients were screened, 50 patients were enrolled (40 screening failures) and 48 patients were randomized. For Part 2, a total of 528 patients were screened, 357 patients were enrolled and 343 patients were randomized. Of these, 5 patients from a significant GCP noncompliance site were excluded in all analysis population.
715776|NCT03146741||
715777|NCT03146585|Adult patients admitted to our ICU with any kind of organ support.|
715778|NCT03146403||
715779|NCT03145818|Recruitment letters to Veterans, Caregivers and Coordinators were sent inviting them to participate in qualitative interviews.|
715780|NCT03145259||
715781|NCT03145207||
715782|NCT03144635||
715783|NCT03144518||Note: 3 Participants were not randomised to condition, as they did not attend primary session.
715784|NCT03144180|Participants were enrolled at an academic medical center between July 2017 and August 2017. The first participant was enrolled on July 19, 2017 and the last participant was enrolled on August 24, 2017.|Of the 32 enrolled participants, 16 were randomized to the study arm.
715785|NCT03143855|32 participants signed the consent form however 5 participants were no shows for the initial visit at which ranndomization occurred.|
715786|NCT03143569||
715787|NCT03143166|This was open label, 2 period, fixed sequence (RT), single arm study in 36 healthy male Japanese subjects. All subjects were orally treated with single dose of 110 milligram (mg) dabigatran etexilate (DE) tablet formulation alone in period 1 and with 20 mg rabeprazole tablet in period 2 with 4 days of rabeprazole pre-medication.|After it had been determined that the subject met all eligibility criteria, a unique subject number was assigned. The number was recorded on electronic Case Report Forms and correspondence regarding the subject. Once a subject number had been assigned, it could not be reassigned to any other subject. Randomisation was not planned in this study.
715788|NCT03143101|The study was conducted from 08 May 2017 through 29 Sep 2017 in the USA.|A total of 200 participants were randomized and participated in the study.
715789|NCT03142932|Participants were recruited through posters advertising the study around the Johns Hopkins Medical Institutions East Baltimore campus, including clinics, inpatient and outpatient facilities, and through participant referrals.|160 participants were assessed for eligibility, 58 did not meet inclusion criteria
715790|NCT03142750||
715791|NCT03142451||
715792|NCT03141931||
715793|NCT03141788||Screen failures because they did not meet Inclusion/Exclusion criteria
715794|NCT03141528||
715795|NCT03141372||
715796|NCT03141307||
715797|NCT03141151||
715798|NCT03141086|Originally 46 subjects were planned to be enrolled in the study. However, 24 subjects were actually enrolled in the study and randomized as the study was prematurely terminated for business reasons.|
715799|NCT03140631||153 patients were enrolled in the trial; however, three patients were removed from the trial before treatment allocation due to physician discretion. These patients never received any treatments and were not included in the analysis.
715800|NCT03139604|Participants took part in the study at 128 investigative sites in 19 different countries.|A total of 498 participants were screened for this study, of which 59 participants were screen failures and 439 participants were randomized to treatment.
715801|NCT03139578|A total of 51 subjects were enrolled in the study from two sites. Of those enrolled, 50 subjects were randomized and 50 subjects were dispensed a study lens. All 50 subjects completed the study, while no one discontinued from the study.|
715802|NCT03139552||
715803|NCT03139448||
715804|NCT03139279||We consented 122 patients of which 8 were immediately excluded for the following reasons: procedure began prior to randomization (3), inclusion criteria not met (3), anesthesiologist declined (1), patient withdrew consent (1); 114 were randomized into the treatment and placebo groups.
715805|NCT03139240||
715806|NCT03139032||
715807|NCT03138967|Participants were screened within days of their scheduled eligible procedure. Enrolled 50 patients, 4 withdrew, we requested IRB approval to enroll 4 more to maintain statistical power. A total of 54 patients were enrolled in the study, but only 50 were assessed for the primary outcome, 1 participant died before POD-7 follow-up.|
715808|NCT03138876||
715809|NCT03138798||
715810|NCT03138655|Participants took part in the study at 72 investigative sites in United States, Belgium, Canada, France, Germany, Hungary, Israel, Netherlands, Poland, Ukraine, United Kingdom and European Union from 8 November 2017 to 26 March 2020.|Pediatric participants who weighed >10 kg with a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) were enrolled in 1:1 ratio to receive vedolizumab low or high dose groups per weight (<30 kg and >=30 kg).
715811|NCT03138590||
716007|NCT03107026||A total 491 subjects were randomized in this study. Five subjects were randomized but never received any dose of study medication.
716194|NCT03075553||
716195|NCT03075527||
715812|NCT03138577|Study subjects were recruited from August 2018 to July 2019. Fifty-nine subjects were assessed for eligibility. Fourteen subjects were excluded or refused to participate, and 21 were eligible but not approached due to the anticipation of insufficient time to complete assessments. Twenty-four patients consented to enrollment.|3 of the 24 enrolled patients were excluded due to baseline abnormal diaphragm motion or inability to visualize the diaphragm on baseline ultrasound scan.
715813|NCT03138382||
715814|NCT03138330||
715815|NCT03137784||
715816|NCT03137693||
715817|NCT03137225|Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.|
715818|NCT03137173|Patients with an ABSSSI who received any systemic antibacterial treatment within 14 days, or topical antibacterial administration on the primary lesion within 96 hours, before first infusion of study drug were not allowed to enter the study. Hospitalization in a medical clinic was mandatory for the first 72 hours.|3 randomized patients were not dosed, due to ICF withdrawal (2 patients) and death (1 patient).
715819|NCT03137069|The study was conducted at 21 centers in 3 countries.|A total of 134 participants were enrolled at 21 centers.
715820|NCT03136861|This study was conducted at 66 centers in 17 countries worldwide: Spain(14), Czech Republic(3), Finland(2), Lithuania(2), Estonia(3), Latvia(3), Switzerland(1), Russia(4), Sweden(4), United Kingdom(5), Belgium(2), Ireland(2), Poland(7), Croatia(3), Bulgaria(5), Greece(5), Italy(1).|At Baseline, patients were randomized to either secukinumab 150 mg or placebo (Group A or B). At Week 8, patients were re-randomized or re-assigned respectively to 1 of 5 treatment arms to receive either secukinumab 150 mg or secukinumab 300 mg (Arm A1 to B2).
715821|NCT03136484|The trial was conducted at 115 sites in Argentina (5), Brazil (2), Canada (8), India (10), Ireland (4), Lebanon (5), Malaysia (5), Mexico (2), Sweden (5), United Kingdom (11) and United States (58).|Study design: Body composition (sub-study) was measured using dual x-ray absorptiometry (DXA) scans in a planned subset of randomised participants.
715822|NCT03136380|This study was conducted at a single center in Tokyo, Japan from 10-May-2017 to 31-July-2017.|A total of 147 participants were screened of which 113 were screen failures the reasons of which were investigator discretion (1), lost to follow-up (2) screened but enrollment target reached prior to enrollment (5) and did not met inclusion/exclusion criteria (105). A total of 18 participants in Part 1 and 16 in Part 2 were enrolled in the study.
715823|NCT03136328|Participants were recruited at Montefiore Medical Center which has medical specializing in the diagnosis and treatment of NETs. Eligible participants were those referred by their physicians for PET (Positron Emission Tomography) or CT imaging due to suspected or confirmed NETs.|
715824|NCT03136198||
715825|NCT03136159|Recruitment of all women admitted to labor and delivery or antepartum service to receive the silver-impregnated dressing should they deliver by primary csection|
715826|NCT03136107|All the participants were randomized at one center in Germany.|
715827|NCT03136068||
715828|NCT03135899|Patients with mild asthma were recruited in this trial, which was split into 2 parts. Part 1 was a multiple-dose, single-blind, double-dummy, randomized, 4-way crossover trial with dose ordered sequences. Part 2 was a multiple-dose, double-blind, double-dummy, randomized, 4-way crossover trial.|All patients were screened for eligibility to participate in the trial. Patients attended a specialist site which ensured that they (the patients) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria was violated.
715829|NCT03135548|This was a randomised, double-blind, placebo-controlled, parallel-design trial to investigate the safety and efficacy of BI 655130 in patients with Palmoplantar Pustulosis (PPP) following multiple intravenous administrations of either low dose or high dose compared with placebo.|All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensured that all participants met all inclusion/exclusion criteria. Participants were not to be randomised to trial treatment if any one of the specific entry criteria were not met.
715830|NCT03135535||
715831|NCT03135522||
715832|NCT03135431||
715833|NCT03135379||
715834|NCT03135028|Participants were enrolled at study sites in Japan. The first participant was screened on 19 May 2017. The last study visit occurred on 26 February 2019.|13 participants were screened.
715835|NCT03135015|Participants were recruited from 26-APRIL-2017 to 24-MAY-2017 at GI Labs (20 Victoria St., Toronto ON, M5C 2N8).|A screening visit was conducted to ensure each participant met inclusion/exclusion criteria for the study. Participants that qualified for the study were separated into either the lean or the overweight group as per protocol (11 subjects/arm).Participants were assigned to a randomization schedule in order of enrollment within each group.
715836|NCT03134963||
715837|NCT03134911|This was an observational, multicentre and cross-sectional study conducted in Departments of Internal Medicine from 47 sites in Spain. The patient received the same anticoagulant treatment for at least 6 months and no more than 2 years.|Data were obtained from a single visit that coincided with one of those performed by the patients as part of routine follow-up of their disease, without interfering with usual clinical practice of the investigator. 535 patients were enrolled and 34 excluded from analysis due to being screening failure and not meeting inclusion/ exclusion criteria.
715838|NCT03134768|Recruitment took place in KK Women's and Children's Hospital|
715839|NCT03134703||
715840|NCT03134599||
715841|NCT03134326||
715842|NCT03134313||
715843|NCT03134248||60 subjects were enrolled for this study (assigned a subjectID), but 11 of these subjects were screen failures, leaving 49 subjects who were randomized for lens assignments.
715844|NCT03134222|Participants were enrolled at study sites in the United States and Canada. The first participant was screened on 24 May 2017. The last study visit occurred on 18 December 2019.|72 participants were screened.
715845|NCT03134183||
715846|NCT03134144|Volunteering participants were recruited via the investigators that collaborated in this study.|"None of the recruited volunteering participants was excluded based on the exclusion criteria.
~One subject dropped out prior to the measurement due to time constraints."
715847|NCT03134092||
715848|NCT03133767||
715849|NCT03133481||
715850|NCT03132753||
715851|NCT03132571||"30 people were screened by telephone.
~18/30 people screened were deemed ineligible. The reasons for ineligibility were: antidepressant medication use (11/18), a history of seizures (4/18) and already taking Naltrexone (3/18).
~12/30 people were eligible, 6/12 were initially interested in the study and ultimately, only 5/6 were consented."
715852|NCT03132298||
715853|NCT03132246||Patients were enrolled if presented as high risk but later separated into the Infected Group or the Not Infected Group based on whether or not they went on to develop an infection post surgery. Group assignment is unknown for patients that did not complete the study and therefore groups are combined for reporting overall study numbers.
715854|NCT03132220||
715855|NCT03131999|18 Subjects signed consent, 2 subjects failed baseline evaluation and were not randomized. 1 subject was randomized, took 4 placebo pills and stopped (without side effects) and is deemed not evaluable.|
715856|NCT03131895|Participants took part in the study at 1 investigative site in the United States from 25 April 2017 to 31 July 2017.|Healthy participants were enrolled in this 2 part study to receive dexlansoprazole 30 milligram (mg) capsules manufactured by Takeda GmbH Plant (Oranienburg, Germany) (TOB) or 30 mg capsules manufactured by Takeda Pharmaceutical Company Ltd. (Osaka, Japan) (TPC) in Part 1 and dexlansoprazole 60 mg capsules by TOB or 60 mg capsules by TPC in Part 2.
715857|NCT03131713||No significant events during pre-assignment stage
715858|NCT03131687||
715859|NCT03131648||The screening period was 2 to 6 weeks and included 1 or 2 visits. The exact duration depended on the wash-out period defined by the exclusion criteria. If no wash-out or only a 2-week wash-out was required, screening Visits 1 and 2 were combined. Eligibility was assessed at the (first) screening visit and on Day 0 prior to randomisation.
715860|NCT03131596|208 patients with moderate to severe (American Fertility Society score ≥ 5) Asherman syndrome who underwent hysteroscopic adhesiolysis were recruited from May 1st,2017 to January 1st,2018.|1 patients was excluded follow the criteria strictly and 7 patients declined to participant. In total, 8 patients were excluded before assignment to groups.
715861|NCT03131479|This study was conducted at 1 centers in the United States.|
715862|NCT03131219||
715863|NCT03131206||The Phase 1 portion of the study includes 3 dose levels that can be explored: Dose Level 1 (starting dose), Dose Level -1, and Dose Level 2. This study enrolled only to Dose Level 1, therefore the baseline and outcome measures presented are for the DL1 participants only.
715864|NCT03131167|The study was conducted at 4 study centers in the United States between 10 May 2017 (first participant first visit) and 30 May 2018 (last participant last visit).|Totally, 63 participants enrolled, randomized and received treatment in two parts of the study with one cohort for one dose level (Part 1: Cohort A1, A2, A3, with single dose and QD multiple dose, followed by Cohort B1, B2, B3 with BID multiple dose. Part 2: Cohort C1, C2, C3 with TID multiple dose, followed by D1, D2, D3 with QID multiple dose).
715865|NCT03130738||
715866|NCT03130257||
715867|NCT03129321||
715868|NCT03129178|96 people were assessed for eligibility from clinic letters, word of mouth, local groups and via the clinical trials website. Recruitment occurred from 06-07-2017 - 29-05-2018.|27 participants were consented.
715869|NCT03128931||
715870|NCT03128892||
715871|NCT03128723|"Recruitment Period: April 04, 2017, to May 10, 2017.
~Location: Clinical site."|
715872|NCT03128411||Currently results are reported based on primary completion date. Data cut-off date was 12 March 2019.
715873|NCT03128372||
715874|NCT03128307|Subjects recruited online. A total of 764 expressed interest in the trial. 143 potential subjects either opted not to participate or did not meet the inclusion/exclusion criteria.|
715875|NCT03128099||
715876|NCT03128086||
715877|NCT03128008||
715878|NCT03127956||
715879|NCT03127943||
715880|NCT03127644|Patients not receiving any therapy for hyperkalaemia and with 2 consecutive potassium values of ≥ 5.1 millimoles/litre (mmol/L) and ≤ 6.5 mmol/L (as measured by i-STAT, a portable blood analyser) were enrolled into 24 study sites in Japan from June 2017 to February 2018.|103 patients were randomised 1:1:1 to receive double-blind treatment of sodium zirconium cyclosilicate (ZS) 5 grams (g) three times daily (TID), ZS 10 g TID, or placebo TID for 48 hours.
715881|NCT03127384||
715882|NCT03127228||
715883|NCT03126682||
715884|NCT03126539||
715885|NCT03126448||
715886|NCT03126344||
715887|NCT03125941||
715888|NCT03125915||
715889|NCT03125395|This study was planned to have 2 cohorts: Treatment Cohort and Observational Cohort. Only the Treatment Cohort is presented in results as there were no participants enrolled in the Observational Cohort.|This study was conducted in participants with cystic fibrosis (CF) aged 2 years and older who participated in parent study VX15-809-115 Part B (NCT02797132).
715890|NCT03125200||
715891|NCT03125031||
715892|NCT03125018||
715893|NCT03125005||
715894|NCT03124979||
715895|NCT03124966||
715896|NCT03124927||
715897|NCT03124901||
715898|NCT03124836||
715899|NCT03124823||
715900|NCT03124797||
715901|NCT03124784||
715902|NCT03124771||
715903|NCT03124758||
715904|NCT03124693||
715905|NCT03124602||
715906|NCT03124563||
715907|NCT03124550||
715908|NCT03124537||
715909|NCT03124407||
715910|NCT03124381||
715911|NCT03124342||
715912|NCT03124199|Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment|There were no significant events in the study after patient enrollment and before assignment
715913|NCT03124108||A total of 68 participants were screened, out of which 45 participants were randomized, 15 participants in each of the 3 treatment groups.
715914|NCT03123874||
715915|NCT03123861||
715916|NCT03123848||
715918|NCT03123471|303 participants were randomized to study treatment at 41 sites in the United States and Canada.|Participants were randomly assigned in a 2:1 ratio to receive either apremilast or placebo. Randomization was stratified by baseline Scalp Physician Global Assessment (ScPGA) score (moderate [3], severe [4]) to ensure balance between treatment arms with respect to baseline severity of scalp psoriasis.
715919|NCT03123393|Participants took part in the study at 26 investigative sites in France, Great Britain, Italy, Spain, Canada, United States from 10 October 2017 to 17 December 2019. The study was terminated by the sponsor before the initiation of the stage 2 efficacy evaluation.|Participants with a diagnosis of relapsed or refractory diffuse large B-cell lymphoma who had at least 2 prior lines of chemotherapy were enrolled in Cohorts A and B. Cohort A received a single dose and Cohort B received ramp-up doses of TAK-659 in Stage 1 of the study.
715920|NCT03123354||
715921|NCT03123263|Retrospective review of medical charts of HER 2 positive, stage 1,2 and 3 breast cancer at Univesity medical center, TTUHSC-EL Paso between Jan 1 2010 and Jan 1 2015.|
715922|NCT03123055||
715923|NCT03122886||
715924|NCT03122587||
715925|NCT03122548||
715926|NCT03122457|Recruitment from July 2015 through August 2019 Please confirm the date of the first enrollment (month, day, year) Please confirm the date of the last study visit or the last date that data was collected (month, day, year)|
715927|NCT03122184||69 participants enrolled in the study but 22 either withdrew their consent or failed to attend their first in-person visit before randomization. Forty-seven individuals were randomized to a treatment condition.
715928|NCT03122171||
715929|NCT03122145|2018-2019 HealthStreet university approved flyers|"Experiment #1: single 60 minute visit with multiple assessments of cough and respiratory function.
~Experiment #2: single 60-minute visit with an instrumental swallowing evaluation (videofluoroscopy)."
715930|NCT03121950||1 participant was excluded due to not meeting criteria on minimum score required for participation on the Mini Mental Status Examination
715931|NCT03121820|Participants recruited at GKB № 15 im. O. M. Filatova Public Healthcare Institution of Department of health care of Moscow, Russian Federation between October and November 2016|18 participants recruited; 25 screened, 7 excluded (5 did not meet inclusion criteria and 2 refused participation).
715932|NCT03121612||There were no wash-out or run-in procedures. No enrolled participant was excluded from the study before randomisation.
715933|NCT03121365||
715934|NCT03121144||
715935|NCT03120676||
715936|NCT03120520||
715937|NCT03120351|80 Enrolled|
715938|NCT03120013||
715939|NCT03119831||
715940|NCT03119688|Participants were recruited from one center in Brazil.|A total of 89 participants were screened, out of which 39 participants did not meet the study criteria. Remaining 50 participants were enrolled in the study, out of which 2 participants were not randomized to the study due to adverse events (AEs).
715941|NCT03119662|The Study was conducted at 29 sites in United States of America & Europe from 8 February 2018 to 19 October 2018. A total of 4 participants with Chronic Kidney Disease (CKD) stage III/IV were enrolled in the study.|Participants were randomized in 1:1 ratio to undergo either contrast-enhanced computed tomography (CECT) or non-enhanced computed tomography (NECT), of which 1 participant withdrew from study.
715942|NCT03119649||
715943|NCT03119610||
715944|NCT03119389|Units within each hospital were recruited to participate in the baseline study. Observation of healthcare worker hand hygiene and glove use were observed during the baseline period. Units with similar hand hygiene and glove use compliance were approached for participation in the study.|
715945|NCT03119181||
715946|NCT03119168||
715947|NCT03119025|The recruitment, assessment and treatment of patients were conducted from May 2015 to November 2016 in a Clinic of Immunopathology affiliated with Institute of Fundamental and Clinical Immunology, that currently holds a license for cell technology application.|
715948|NCT03118947|This open-label extension study included patients completing double-blind, randomised, placebo-controlled study ACP-103-032 (NCT02992132).|Patients from parent study ACP-103-032 who were eligible to participate in this study were consented prior to the final procedures performed for study ACP-103-032 at Week 12. The ACP-103-032 Week 12 visit was also considered the baseline visit of study ACP-103-033. The ACP-103-033 result tables are all based on the safety analysis set (n=78).
715949|NCT03118934|Subjects were recruited from 20 investigational sites located in the United States (14), United Kingdom (3), and Canada (3).|Of the 188 enrolled subjects, 6 were exited prior to trial fit. This reporting group includes all subjects randomized and trial fit, as randomized (182). Safety Analysis Set is reported as exposed.
715950|NCT03118843|Participants were enrolled at study sites in North America, Europe, New Zealand, and Australia. The first participant was screened on 25 April 2017. The last study visit occurred on 19 March 2018.|38 participants were screened.
715951|NCT03118765||A total of 155 subjects were randomized to study treatments.
715952|NCT03118739|This study was conducted at 19 clinical research centers in the United States of America. First subject enrolled (First subject first visit/first consent signed date): 18 May 2017. Last subject last visit: 13 August 2018.|Patients were screened at Visit 1. Within 1 week, eligible patients collected 3 morning void samples on consecutive days for proteinuria measurements. Patients with acceptable results were scheduled for Visit 2. Prior to randomization and before or on the day of Visit 2, patients underwent MRI. V2 occurred no later than 6 weeks after V1.
715953|NCT03118596||
715954|NCT03118297||
715955|NCT03117569|From 21 August 2017 to 16 July 2018, participants were screened and enrolled at 33 sites in Australia (n=6), Canada (n=7), France (n=3), Germany (n=4), New Zealand (n=4), Switzerland (n=2), United Kingdom (n=3), and United States (n=4). Study recruitment was in tertiary specialist viral hepatitis clinics (n=30) and primary care clinics (n=3).|
715956|NCT03117517||
715957|NCT03117361|Patients participated between 15May2017 - 30Jul2018 (last follow-up cutoff date). The 1st dose/1st cycle was administered on 15May2017 and the last dose/last cycle on 23Jul2018. At cutoff date 10 patients had been included and treated with plitidepsin+BTZ+DXM and they were evaluable for safety. 8 of these were evaluable for the efficacy endpoint|IC signed;Age≥18 years;confirmed diagnosis of MM,ECOG PS≤2;LVEF≥45%;negative pregnancy test
715959|NCT03116841|Participants took part in the study in Japan, from 02 August 2017 to 20 December 2017.|Participants with a historical diagnosis of reflux esophagitis, undergoing maintenance treatment with a proton pump inhibitors (PPI) after initial treatment, and with Pittsburgh Sleep Quality Index (PSQI) global score ≥ 6.0 at the start of administration (VISIT 2) were enrolled and was administered vonoprazan 20 mg once daily for 8 weeks.
715960|NCT03116828||
715961|NCT03116698|Approximately 240 subjects were expected to be randomized, but 238 subjects were randomized and included in the ITT population and 183 subjects were included in the Per Protocol population.|
715962|NCT03115853||The data for this study was lost. The total number of participants enrolled/completed was pulled from IRB records. Participant age was between 18-65 per protocol. All participants were enrolled in the United States. No other data is available.
715963|NCT03115827||
715964|NCT03115580|Participants enrolled between May 2017 and March 2019.|
715965|NCT03115476||"1234 participants were randomised and applied investigational medicinal product (IMP) in the trials LP0084-1193, -1194, -1195, -1196 (main trials, Period 1).
~A total of 563 participants from the main trials continued and were enrolled into this extension follow-up trial (LP0084-1369, Period 2)."
715966|NCT03115411||
715967|NCT03115177||
715968|NCT03114995|Consecutively enrolled patients who are already stabilized with standard medical treatment and diagnosed with Non-ST elevation acute coronary syndrome (NSTE-ACS) at Seoul National University Bundang Hospital from February 2012 to October 2015|
715969|NCT03114969|This was an open-label study investigating error rates for ELLIPTA dry powder inhaler (DPI), alone or in combination when compared to other DPIs (DISKUS, Turbuhaler, HandiHaler and Breezhaler) and combinations of these, as prescribed to chronic obstructive pulmonary disease (COPD) participants, prior to any retraining in correct use.|A total of 461 participants were screened of which 11 failed screening and 450 participants were enrolled. The study was conducted in two countries-Netherlands and the United Kingdom.
715970|NCT03114683|Update analysis data cutoff date of safety data: 30 Sep, 2019. Update analysis data cutoff date of efficacy data: 12 Feb, 2018.|
715971|NCT03114657|The study was conducted at 209 centers in 27 countries.|A total of 806 participants were enrolled at 209 centers. 4 participants did not receive any study treatment meaning that the modified intent-to-treat and safety populations consisted of 802 participants.
715972|NCT03114488||
715973|NCT03113916||
715974|NCT03113656||
715975|NCT03112993|"Recruitment Period
~First subject on study: 30/MAY/2017; Last subject off study: 14/AUG/2018.
~Locations: University Hospital and Missouri Orthopaedic Institute, University of Missouri, Columbia, Missouri, United States of America."|
715976|NCT03111550||A total of 242 subjects were enrolled in this study, and 229 subjects were implanted with study IOL in first eye.
715977|NCT03111316||
715978|NCT03111108|Adult male and female participants with chronic hepatitis C virus (HCV) genotype 4 (GT4) infection were enrolled at 12 study centers in France.|
715979|NCT03110900||
715980|NCT03110770|Part A targeted healthy adults only. Part B included adolescents in the study population. Part B sites had the option to enroll adolescents and adults, or choose to enroll only adults. The study was conducted at sites located in areas of confirmed or projected active transmission of Zika virus (ZIKV) infection.|
715981|NCT03110692||
715982|NCT03110601||Non-randomized cross-over study in which all eligible participants received the same order of procedures (i.e. Conventional SCS parameters for 4 days, then a washout period of 1 day, then PM-SCS parameters for 4 days).
715983|NCT03110471||
715984|NCT03110458||
715985|NCT03110380|Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 June 2017. The last Week 48 study visit occurred on 04 December 2018.|633 participants were screened.
715986|NCT03110185|Participants were either recruited pre- or post-operatively for study procedures depending on availability of equipment and research staff.|Participants were not assigned to groups, as baseline delirium status determined which group the participants fell into (delirium vs. no delirium).
715987|NCT03110159||
715988|NCT03110029||
715989|NCT03110003||
715990|NCT03109951||None noted as this was a single-arm study.
715991|NCT03109873||
715992|NCT03109769||
715993|NCT03109418||"Three participants were excluded prior to randomization due to the following reasons:
~The patient was experiencing on-going neurological issues and was therefore removed from the study prior to randomization.
~The patient missed his/her own surgery date.
~The patient ended up having outpatient surgery, and was therefore excluded."
715994|NCT03109184|Families were individually randomized at the level of the dyad, thus our study randomized 119 dyads. Parents and teens were not randomized separately. There were only two study arms, CONTROL families and STRONG families.|
715995|NCT03109015||
715996|NCT03108924||This was an open-label, 2-part, single dose study. In Part 1, MK-7264 was evaluated in participants with moderate and severe renal impairment (RI) compared to healthy matched control participants. In Part 2, MK-7264 was evaluated in 2 periods in participants with end stage renal disease (ESRD) requiring hemodialysis (HD).
715997|NCT03108521|All subjects ware recruited in medical clinic of Sichuan Provincial People's Hospital during July 26th 2016 to October 12th 2017.|
715998|NCT03108482||
715999|NCT03108469||
716000|NCT03108157|Recruitment started on January 2017 and finished in October 2018. All patients were recruited at ProcreaTec Fertility Clinic in Madrid|
716001|NCT03108027||
716002|NCT03107754||
716003|NCT03107715||
716004|NCT03107611||
716005|NCT03107377||
716006|NCT03107052|A total of 275 participants with episodic cluster headache (ECH) or chronic cluster headache (CCH) were enrolled in this study.|Participants were assigned to receive treatments in fremanezumab 225 milligrams (mg) monthly, fremanezumab 675/225 mg monthly, or fremanezumab 675 mg quarterly groups; based on their randomization in the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338).
716591|NCT03017261||
716592|NCT03017235||
716593|NCT03017040||
716008|NCT03106870|"The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.
~Sixty two pregnant women were recruited from Ain Shams university maternity hospital who fulfilled the inclusion criteria. They were counseled and after consenting were included into the study."|
716009|NCT03106844||
716010|NCT03106753||
716011|NCT03106636|"Numbers reported are number of participants (caregivers and their children).
~The Protocol Enrollment number (442) differs from the number of participants in the Started category (416) due to a control group condition (services as usual) being removed from the study early on. 416 started in the two study conditions (KEEP-P and KEEP-P+)"|
716012|NCT03106337||
716013|NCT03106077||96 participants signed consent, 54 enrolled during prescreening and 42 enrolled during enrollment, 94 were ineligible due to 4 died prior to starting treatment, 1 found not to be Triple negative breast cancer, 4 withdrew, 73 FR alpha negative, 11 insufficient tissue for analysis of FR alpha and 1 trial closed prior to enrollment.
716014|NCT03105518||
716015|NCT03105479|Due to early termination of the study after sponsor's decision to discontinue the development of cadazolid, only one patient was enrolled at one site in the US.|
716016|NCT03105362|Male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease), who were on a stable enteral nutrition regimen (oral rehydration fluids taken orally) between the ages of 1-17 were recruited from clinic.|No run-in or wash out period prior to participating in study.
716017|NCT03105297|Participants were recruited from one center in Australia.|103 participants were screened, out of which 9 were screening failure, 3 did not want to participate. Remaining 91 participants were included in the safety population.
716018|NCT03104985||
716019|NCT03104816|28 patients were involved in study. 22 patients completed the study. Patients were recruited in the surgical clinic, preoperative clinic, preoperative surgical area.|Patients were included in the study according to their inclusion and exclusion criteria. There were no patients were excluded from study in the period after signing the consent to assignment to groups.
716020|NCT03104738||
716021|NCT03104647|Recruitment took place at the Shaare ZedeK Medical Center during the 5th of July 2017.|
716022|NCT03104322||
716023|NCT03104192||
716024|NCT03103919|The study started to enroll patients in March 2017 and concluded in January 2018.|Participant Flow refers to the Safety Set (SS), which consists of all subjects who received at least 1 dose of Neupro. One subject who received Neupro after screen failing was not considered as treated within the study and, therefore, not included in the SS.
716025|NCT03103906|All participants were recruited at a single center in Brazil.|A total of 141 participants were screened, out of which 106 participants were enrolled in the study. 35 participants were not enrolled as 30 did not met study criteria, 2 had adverse event and 3 were lost to follow up. Out of 106, 82 participants were randomized and 24 were not randomized because of other reasons (unspecified).
716026|NCT03103763||
716027|NCT03103503||
716028|NCT03103282||
716029|NCT03103100||
716030|NCT03103061||
716031|NCT03102918||
716032|NCT03102879|Recruitment between September 2016 and September 2017, from patients referred for endodontic treatment to the Universidad de los Andes Health Center, located in San Bernardo city, Santiago, Chile.|
716033|NCT03102762||
716034|NCT03102736|40 participants enrolled, 14 were excluded before starting the study and 10 were excluded after starting the study but before randomization (6 were ketamine non-responder, 2, failed to return to baseline, and 2 withdrew before randomization)|
716035|NCT03102710||18 subjects were dropped prior to randomization. Reasons for this included inconsistent or non-differentiable pain ratings to heat stimuli, pain thresholds that were too high or low, inability to finish subsequent sessions, too much discomfort with noxious stimuli, no SSN/hairstyle incompatible with tDCS, participated in a previous pain study.
716036|NCT03102411|The online survey took place from 3/9/2017 to 3/11/2017 through SurveyMonkey® (Palo Alto, CA, USA). The survey was distributed securely to a representative sample of the US population. 1881 subjects responded to the survey with 1718 completing all the questions (91% completers).|
716037|NCT03102190||
716038|NCT03102034|Recruitment period was from April to October 2017. Participants were recruited from medical clinics.|
716039|NCT03101592|"Recruitment relied on active identification and referral of stable patients by clinic staff. Clinics were randomized to a study arm, and enrolled individuals initiated the study drug dispensing interval to which the clinic had been randomly assigned.
~A total of 14,430 individuals were screened from May 2017- April 2018 across 30 study sites."|
716040|NCT03101462||
716041|NCT03101371|A single-site randomized controlled trial, conducted at the University of Colorado Hospital, enrolled women beginning October 2017 and ended February 2019.|
716042|NCT03101293|Participants took part in the study at 1 investigative site in the United States from 04 April 2017 to 26 May 2017.|Healthy participants were enrolled in this 2-way crossover study and randomized in 1 of the 2 treatment sequences which determined the order to receive TAK-831 400 milligram (mg) film-coated tablets under fasted conditions and TAK-831 400 mg tablet under fed conditions (nutritional drink).
716043|NCT03101267|A total of 150 participants with cedar pollinosis were enrolled in this study. Participants were randomly allocated to 3 groups in a ratio of 1:1:1 to ASP4070 4 mg group, ASP4070 1 mg group or placebo group.|"Class of Japanese Red Cedar (JRC) pollen-specific Immunoglobulin E (IgE) antibody test at screening visit 1 and Change from pre-exposure in mean total 3 nasal symptom (sneezing, nasal discharge and nasal congestion) score 120 to 180 minutes after start of cedar pollen exposure at screening visit 2 were used as stratification."
716044|NCT03101150||416 participants were screened. 192 did not meet eligibility criteria. 38 refused to participate and 7 turned out to be ectopic pregnancy.
716081|NCT03096314||After initial study screening, eligible patients were consented and received secondary screening for vitamin D deficiency; performed via an FDA-approved test (either hospital clinical laboratory or the FastPack IP device (Qualigen Inc., Carlsbad, CA). Participants with a screening 25OHD level <20 ng/mL were randomized for treatment assignment.
716082|NCT03095885||
728893|NCT01870869||
716045|NCT03101033|Participants were assessed in the pain clinic of xijing hospital by a separate clinician, their clinical data and phone number were recorded. The total of 186 participants were assessed and 92 of them were enrolled.|Ninety-four participants were excluded before assignment. Sixty-three of them did not meet the inclusion criteria. Twenty-four of them refused to participate. Seven participants were excluded as other reasons such as the physician was uncertain about the diagnosis or the participants was difficult to communicate with.
716046|NCT03101020|All participants were recruited through third party referral from the Health Center of the University of Queensland. The date of recruitment was from 06/01/2017 to 06/16/2017. The participants usually knew about the study through advertisement on online social media or through folders on the Health Center clinic.|There were no events that occur after participant enrollment, but prior to assignment of participants to a group
716047|NCT03100968||
716048|NCT03100942|Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 01 May 2017. The last study visit occurred on 02 October 2019.|348 participants were screened.
716049|NCT03100864|This was an Phase IIa multi-centre, non-randomised, uncontrolled single arm), open-label, exploratory trial to assess biomarker changes in response to Interleukin-36 signalling blockade induced by treatment with spesolimab in patients with moderate to severe active Ulcerative colitis.|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
716050|NCT03100838|A total of 64 subjects were dosed.|
716051|NCT03100825||A total of 161 participants were screened, of which 94 participants entered the treatment phase. A total of 86 participants completed the study.
716052|NCT03100617||
716053|NCT03100500||
716054|NCT03100344|This study was conducted at 57 investigational sites in Australia, Canada, Germany, France, Poland and the United States.|In this study, 226 participants with moderate-to-severe atopic dermatitis (AD) were randomized across the 4 treatment groups after a 2 to 4-week run-in period. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures.
716055|NCT03100123||
716056|NCT03100058|Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.|Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.
716057|NCT03099694|From May, 2017, through July, 2018, a total of 18 centers screened 2509 infants, of which 1385 were eligible. We recruited 340 infants (170 in each group), to account for dropouts. Finally, 302 infants completed the trial (152 in NHFOV; 150 in NCPAP group.)|"1045 Did not undergo randomization
~663 Refused to participate
~382 NHFOV devices not available"
716058|NCT03099655||"Out of 471 initial enrollments;31 were excluded due to the following:
~No implant attempted(23)
~Investigator deemed not medically necessary(4)
~Insurance declined coverage(2)
~Patient did not meet criteria for the study(1)
~Investigator withdrew, not a good candidate(1)
~Resulting in 440 subjects with 4798 Lead implant attempted"
716059|NCT03099538||
716060|NCT03099369||
716061|NCT03099187||
716062|NCT03099161||This study was planned to have 2 parts: a dose escalation/confirmation phase (Part 1) and an expansion phase (Part 2). The expansion phase was not conducted due to early study termination.
716063|NCT03099096|Participants with severe eosinophilic asthma, were enrolled at 16 sites in the United States of America, 6 sites in Germany, 5 sites in the United Kingdom, 4 sites in Canada, 3 sites in Australia, 2 sites in Russia and 2 sites in Sweden. The study duration lasted from 04 May 2017 to 30 November 2017.|Of the total 181 participants screened, 22 were screen failures and 159 were enrolled in this open-label, single arm, repeat dose study of mepolizumab and attempted to self-administer at least one dose of study treatment.
716064|NCT03098979|The study was conducted at 76 study centers in 12 countries, between 10 May 2017 (first patient first visit) and 20 June 2018 (last patient last visit)|A total of 339 subjects entered the screening period, of whom 34 withdrew before randomization. The remaining 305 subjects were randomized and received at least one dose of study drug
716065|NCT03098966|This is a retrospective study that was performed at Ain Shams University Maternity Hospital during the 3-year period from January 2013 to December 2015.|
716066|NCT03098745||
716067|NCT03098641|Between January 2013 and December 2016, in 10 secondary and tertiary French care centres|Patients were excluded if they did not attend their follow up visit within 30 days of surgery.
716068|NCT03098615||
716069|NCT03098173||
716070|NCT03098030||
716071|NCT03097861|This trial was conducted at 66 investigative sites in the United States.|Actual randomization ratio of sprinkle:placebo:capsule (2:1:1) was different than the planned randomization ratio (1:1:1)
716072|NCT03097614|Of the 57 enrolled subjects, 54 subjects completed the study. All 57 subjects enrolled in the study were included in FAS and safety populations|
716073|NCT03097484||
716074|NCT03097341||A total of 105 participants were screened for the study, of which 84 did not meet eligibility criteria or declined to participate. The remaining 21 participants were randomized into the study, with each dose level occurring in sequential order.
716075|NCT03097289|"A participant was considered enrolled upon signing the informed consent form."|"33 participants consented/enrolled: 1 screen-failed; 32 participants started an apheresis procedure and were therefore included in the Safety Analysis Set
~6 participants did not complete all study procedures, resulting in 26 participants completing the study; 2 participants met the Full Analysis set exclusion criteria
~24 = Full Analysis set"
716076|NCT03097133||
716077|NCT03097029||
716078|NCT03096873||
716079|NCT03096483||
716080|NCT03096444||
716083|NCT03095651||No participants were randomized to the T1DM (Type 1 Diabetes Mellitus) MK-5160 64 nmol/kg arm or the T2DM (Type 2 Diabetes Mellitus) MK-5160 16 nmol/kg arm.
729026|NCT01860573||
716084|NCT03095638|This study was conducted at 1 site in the United States of America from 03 May 2017 to 23 Jun 2017. The study was conducted in 2 parts and a total of 38 participants were enrolled: 14 in Part 1 (treatment A and B over 2 dosing periods) and 24 in Part 2 (treatment C,D,E, over 3 dosing periods) with washout of 7(-4 hours) days between doses.|A total of 106 participants were screened however 68 were screen failures the reasons for which were did not meet inclusion/exclusion, adverse event, lost to follow up, investigator discretion, withdrew consent and screened but enrollment target reached prior to enrollment. All of the 38 enrolled participants completed the study.
716085|NCT03095599||"Phase 2 was conducted at the District Health Center (DHC) of Ben Luc, Long An Province and involved 252 subjects. After positive safety review of Day 8 data, Phase 3 was at 2 sites: the DHC of Ben Luc, Long An Province and the DHC of Long Thanh, Dong Nai Province.
~In total, of the 1399 subjects who were screened, 888 subjects were rand"
716086|NCT03095521|The trial included a screening period, up to 5 days active treatment, and follow-up visit. The patients had to visit the trial site up to 3 times.|228 patients in total were included
716087|NCT03095508|The trial included a screening period, up to 5 days active treatment, and follow-up visit. The patients had to visit the trial site up to 3 times.|229 patients in total were included
716088|NCT03095456||
716089|NCT03095053|The patient population of the RCT consisted of patients who underwent autologous blastocyst freeze-all IVF cycles between March and October 2016, at a private IVF center|Excluded (N =82) Patients with no blastocyst Patients with <2 blastocysts Patients with only one 2BB blastocyst
716090|NCT03095027|Subjects were recruited from 3 study centers located in the United States.|Of the 54 enrolled, 3 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (51).
716091|NCT03094806||
716092|NCT03094325|All patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy|
716093|NCT03094195||Two hundred thirty patients were screened.
716094|NCT03093662||
716095|NCT03093415|Participants for the medication assisted therapy (MAT) group were all recruited and enrolled from within a single FQHC that provides office based opioid treatment with buprenorphine. Participants in the needle exchange program were similarly recruited in that setting. Retrospective comparison group was an academic hepatology referral clinic.|This is a non-randomized, prospective cohort trial. No washout/run-in occured.
716096|NCT03093350||
716097|NCT03093324|Participants were enrolled at 70 investigative sites in the United States (US), Germany, and Poland from March 15, 2017 to June 27, 2019.|A total of 506 participants with relapsing remitting multiple-sclerosis were enrolled in this study. Of which 504 participants received study drug and randomized in Parts A and B of the study (253 participants in ALKS 8700 group and 251 in Dimethyl Fumarate group). A total of 478 participants completed the study.
716098|NCT03093272||
716099|NCT03093207||
716100|NCT03093181|All the participants were recruited from one center in Brazil.|"Out of 205 screened participants,157 participants were enrolled, and 132 participants were randomized. 25 enrolled subjects were not subsequently randomized. Out of 132 randomized participants,1 participant was misallocated to treatment (received no treatment instead of positive control)."
716101|NCT03093025||
716102|NCT03092791|Participants took part in the study at four investigative sites in Panama from 7 June 2017 to 18 October 2018.|Healthy participants were randomized to one of two (adult and toddler lead-ins) or four (infant dose ranging) arms in a 1:1 or a 1:1:1:1 ratio, to receive sIPV or reference sIPV. Two groups received placebo.
716103|NCT03092752|This was a retrospective observational cohort study. The data was taken from Medical Data Vision (MDV) database for the duration from 1st January 2014 to 30th September 2016 .|The data of 523585 patients was available in the MDV database having a diagnosis of Type 2 Diabetes Mellitus (T2DM) of which data of 162116 eligible patients was included in this study.
716104|NCT03092726|Participants with fibromyalgia (FM) were enrolled in 24 sites in the United States.|Participants underwent a screening period (up to 42 days), where washout of medications and a 7-day baseline diary run-in were completed. Participants were randomized (1:1 ratio) after confirmation of eligibility (which also required a mean daily average pain score of ≥ 4 and ≤ 9 [per Daily Average Pain Numerical Rating Scale] to enter the study).
716105|NCT03092479||
716106|NCT03092375||
716107|NCT03092219|A total of 202 subjects were randomized with 150 subjects allocated to TEOSYAL RHA® Redensity and 52 subjects allocated to No-Treatment control.|
716108|NCT03091920||
716109|NCT03091777|"Recruitment Period: March 2017 to November 2017
~The location of clinical sites included women's health clinics and clinical research centers"|All subjects who met the entry criteria were randomized and enrolled into the study.
716110|NCT03091751||
716111|NCT03091673||
716112|NCT03091439|Although this was a planned multi-center study, the study was terminated and only one investigative site in the United States enrolled a participant.|
716113|NCT03091400|Enrollment Period: 03/16/2017 - 02/20/2018. There was a two-phase screening. Of the 35 participants who met initial screening criteria (e.g., age, MS diagnosis), 24 did not meet secondary screening requirements (e.g., objective memory impairment on assessment). Eleven (11) participants met secondary screening requirements and were randomized.|
716114|NCT03091361||
716115|NCT03091348||
716116|NCT03091192|First subject enrolled: 25 July 2017. Last subject last visit: 18 August 2019. Data cut off: 19 August 2019. The study was terminated prematurely. Randomized subjects continue to receive IMP as clinically indicated by PI; safety information is being collected for those subjects.|
716117|NCT03091179||
716118|NCT03090958|Participants were recruited from October, 2016-November, 2016. Participants were recruited from the Cook County Health and Hospitals Systems Infectious Disease Clinic.|21 individuals were contacted to recruit them into the study. 20 participants were consented and enrolled, but 21 individuals were assessed for one of the feasibility measures.
716119|NCT03090256|Subjects were recruited from 2 investigative sites located in Japan.|Of the 76 enrolled, 8 subjects were exited as screen failures prior to implantation. This reporting group includes all implanted subjects (68).
721816|NCT02420353|Recruitment completed at the University of Michigan Sports Medicine Clinic|
716122|NCT03089879|A total of 35 subjects were enrolled into the study. Of these, 7 and 2 eligible subjects from the H03_01TP parent study were enrolled into the Shigella Group and Placebo Group, respectively. 26 subjects were enrolled into the Naïve Group. All 35 subjects were vaccinated and analyzed for immunogenicity and safety.|The subjects in Naive Group, who were not part of the H03_01TP study, were added in order to have a more balanced number of previously unvaccinated and vaccinated subjects in the extension trial.
716123|NCT03089853||
716124|NCT03089580|14 participants were recruited. Each participant received the Intense Pulse Light treatment in one eye and the sham treatment in their other eye.|
716125|NCT03089216||A total of 325 participants were examined to check whether they met the inclusion and exclusion criteria; 217 participants were excluded because they presented initial conditions described in the exclusion criteria of the study; 108 were enrolled.
716126|NCT03088917|After identification of lost to follow-up hepatitis C patients, patients who were alive and residing in the Netherlands were invited for re-evaluation at the outpatient clinic.|After invitation, patients could not be enrolled (defined as the signing of informed consent) for multiple reasons. These reasons are described below.
716127|NCT03088345||
716128|NCT03088267|Date first subject enrolled: February 11, 2017 Date last subject completed: February 25, 2017|All 18 subjects were enrolled and completed the study.
716129|NCT03088137|Subjects were screened and enrolled at 3 In Vitro Fertilisation (IVF) centers in Russian Federation from 08.02.2017 - 17.08.2018.|Of 118 participants: 8 were reported as screening failures prior the group assignment.
716130|NCT03087643||
716131|NCT03087604||
716132|NCT03087513|"Between February 2018 and April 2019, 73 posterior cervical spine patients screened from the preoperative assessment clinic of Toronto Western Hospital to identify eligible patients.
~First participant was enrolled on March 2018 and the last participant was enrolled on April 2019."|"40 participants received 10ml syringe containing Sugammadex (2mg/kg) in the first phase, followed by Placebo 10 ml in the second phase or 10ml syringe containing Placebo in the first phase, followed by 10 ml of Sugammadex (2mg/kg) in the second phase.
~Time interval of approximately 3 hours between initial and crossover arm. 2 Patients withdrawn"
716133|NCT03086707||
716134|NCT03086551|Recruitment was conducted through mailings to individuals identified as having been admitted to the University of Michigan Health System in the past 5 years (from 01/01/2012 to 01/27/2017) for treatment of middle cerebral artery stroke. Mailings were sent to those individuals with zip codes in the state of Michigan and northwest Ohio.|Enrolled participants were excluded prior to randomization for: known contraindication to the transcranial magnetic stimulation intervention (n=1) and a broken foot, not study related, between enrollment and randomization (n=1).
716135|NCT03086447|A total of 267 subjects were enrolled into this study. Of the enrolled 262 were randomized to receive a study lens, while 5 subjects failed to meet the eligibility criteria. Of the 262 randomized subjects, 231 completed the study and 31 subjects were discontinued.|One subject was randomized to the Test lens but in actuality was dispensed the control lens, therefore his/her data was summarized with the control data, while this/her demographic information is apart of the Test summary.
716136|NCT03086408||
716137|NCT03086356|This was a single-centre, open-label trial in 1 group of healthy volunteers. The trial included a 2-week treatment period during which the subjects were hospitalised at the trial site and a follow-up period of approximately 3 months.|"Healthy male and female volunteers, aged ≥18 and ≤45 years, body weight
~≥50 kilograms (kg) with a Body Mass Index (BMI) in the range from ≥19 to <24 kilogram per square meter (kg/m2) were included in the trial."
716138|NCT03086343|The study had a 24-week, randomized, double-blind, parallel-group, active-controlled period (Period 1) and an ongoing open-label long-term extension study (Period 2). Results from Period 1 are reported.|Full Analysis Set: all randomized participants who received at least one dose of study drug during Period 1; one participant who was a screen failure was randomized in error and did not receive study drug.
716139|NCT03086330|The trial was conducted at 61 sites in 6 countries as follows: Austria (4 sites), Canada (8 sites), Japan (4 sites), Norway (4 sites), Russian Federation (5 sites), United States of America (USA) (36 sites). In addition, 1 site in Norway and 3 sites in the USA screened, but didn't randomise any participant.|
716140|NCT03086265||
716141|NCT03086213||
716142|NCT03086135||
716143|NCT03086018||
716144|NCT03085914|The study was conducted at 9 study sites in the United States. For each treatment group, results included data contributed by participants from Phase 1 and 2. Results for Treatment Groups C, D, and E contain data from Phase 2 mandatory biopsy cohort participants. No Phase 2 participants were enrolled in any efficacy expansion cohort.|A total of 70 participants were enrolled in the study. Study enrollment was permanently discontinued on 25 Oct 2018 as a strategic decision. At the time of data cut-off date of 25 Jan 2019, 11 participants were ongoing on treatment.
716145|NCT03085836|Participants took part in the study at 1 investigative site in China from 19 April 2017 to 17 August 2017.|Healthy Chinese participants were enrolled in this study to receive treatment in one of the 3 treatment groups: TAK-438 10 milligram (mg) once daily or TAK-438 20 mg once daily or TAK-438-20 mg twice daily.
716146|NCT03085797|Participants (par.) were enrolled across 11 countries (Germany, Netherlands, Romania, Sweden, United Kingdom, United States, Argentina, Australia, Canada, Republic of Korea and Russian Federation).|A total of 414 participants were enrolled and randomized in the study, of which only 407 participants received study treatment and were included in the Intent-to-Treat Population (defined as all randomized participants who took at least 1 dose of study treatment). Seven participants did not receive study treatment as they were randomized in error.
716147|NCT03085238|Prospective, multi-center, non-blinded, single-arm study|
716148|NCT03085017||
716149|NCT03084315||
716150|NCT03083990||
716151|NCT03083847||121 participants were screened; 55 participants were assigned to an arm; 66 participants did not meet screening criteria; one subject was consented to two arms, but started on only a control arm.
716152|NCT03083769||
716196|NCT03075449||A cross-sectional participant survey study combined with 12 months of retrospective data collection from participant's PCP medical records.
718241|NCT02770625||A total of 9 patients were planned to be enrolled in the study; 8 patients were enrolled into the study and all 8 patients completed the study.
716153|NCT03083639|Participants took part in the study at 1 investigative site in the United States from 27 March 2017 to 13 May 2017.|Healthy participants were enrolled in this 2-way crossover study and randomized in 1 of the 2 treatment sequences to receive esomeprazole 40 milligram (mg) capsule (Regimen A) or esomeprazole 40 mg tablet (Regimen B) under fasted conditions.
716154|NCT03083483|The recruitment period ran from 5/1/17 to 12/20/17. Subjects were recruited off of the Duke University Behavioral Research Lab Sessions Scheduling Website for undergraduate and graduate students, Duke School of Medicine students in the Trent Semans Center and Duke South Clinics, and Duke Pre-Medical undergraduate students.|2 participants were screen failures
716155|NCT03083470||
716156|NCT03083379||
716157|NCT03082599||A total of 120 patients were enrolled and randomized; however, data from only 79 patients was analyzed due to major procedural issues at one site. One patient in the Emmetropia group missed the 3-month visit.
716158|NCT03082586||
716159|NCT03082196||
716160|NCT03080961|Upon written informed consent, 82 subjects were enrolled based on their medical history of recurrent genital herpes.|Of the 82 subjects enrolled, 46 had a confirmed HSV-2 infection and started applying VIBLOK.
716161|NCT03080493||
716162|NCT03080454||All participants received both the anodal and sham trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS) conditions, and sequence of stimulation conditions was the same across participants, with sham stimulation preceding active stimulation.
716163|NCT03079531||
716164|NCT03079375||
716165|NCT03078946||Patients were excluded if: (1) patient's refusal, (2) allergy to any drugs of the study, (3) history of drug or alcohol abuse, (4) history of uncontrolled diabetes or hypertension, (5) history of chronic pain or daily intake of analgesics within 24 h before surgery, and (6) impaired kidney or liver functions.
716166|NCT03078816||
716167|NCT03078647||
716168|NCT03078595|At the Haemophilia Centre, Medical Clinic III/Institute for Transfusion Medicine, Hospital of the Johann Wolfgang Goethe-University Frankfurt/Main approximately 1500 charts of VWD patients were screened rendering about 35 patients with VWD type 2 and 3.|From July 16, 2015 to July 15, 2016 24 type 2 and 3 VWD cases were enrolled. Due to the difficulty to find more type 2 and 3 VWD patients willing to participate recruitment was stopped in March 2017 after enrolment of 24 individuals. From April 04, 2016 to March 24, 2017 24 patients that self-reported to be hematologically healthy were enrolled.
716169|NCT03078582||
716170|NCT03078556|The study was conducted in 2 parts (Part 1 and Part 2) at a single center in the United States from 27-March-2017 to 18-August-2017 and 154 participants (78 in Part 1 and 76 in Part 2) were randomized. First 16 participants completing the first 2 dosing periods, returned for a 3rd treatment period and received single dose of FDC with high fat meal|A total of 283 (Part 1: 150, Part 2: 133) participants were screened for this study; 125 (Part 1: 72, Part2: 53) participants were screen failures (SF) and 4 participants were reserved but not used. The reasons for SF: inclusion/exclusion criteria not met (105), withdrew consent (18), physician decision (2).
716171|NCT03078504||
716172|NCT03078478|The trial was conducted at 230 sites in 11 countries as follows. Number of sites that screened and randomised participants to treatment are given in parenthesis. Canada:(9/9), Denmark: (6/6), Estonia: (5/5), Germany: (11 /11), Greece: (7/7), Hungary: (9/9), Norway: (4/4), Poland: (9/9), Romania: (5/4), Serbia: (8/8), United States: (157/153).|The participants were previously treated with basal insulin once daily or twice daily ± oral anti-diabetic drugs excluding sulfonylureas/glinides. Pre-trial insulin was discontinued and the subjects continued their pre-trial oral anti-diabetic drugs (OADs).
716173|NCT03078270||
716174|NCT03078127|Patients were screened and recruited from the adult CF clinic at UNC from January 2017 to December 2017.|"Following screening, patients performed a baseline study visit prior to randomization into the study arms which determined which order to complete the other three interventions would be performed. Baseline (or huff-cough) was completed prior to randomization to ensure comparator data if a patient was unable to complete the study."
716175|NCT03077919|123 participants screened eligible and completed the baseline CAPS-5|113 participants were randomized to treatment/sham and underwent the study procedure at Week 0 and Week 2.
716176|NCT03077893||A total of 44 subjects were enrolled into the trial and given active Provant Therapy. A total of 7 subjects dropped out of the study prior to being randomized 1:1 active to sham. Since these subjects withdrew from the study prior to assignment to an arm, they are not included in the randomized total of 37 (18 active and 19 sham).
716177|NCT03077724||
716178|NCT03077711|104 patients actually signed consent to participate but 12 were excluded due to screening failure, decision to decline participation after signing consent, renal failure discovered after enrolling patient, and one unrelated death|
716179|NCT03077659||
716180|NCT03077607||Study was conducted in 4 countries from 07-Nov-2016 to 18 Dec 2017.
716181|NCT03077438|Study participants were enrolled in 36 centers in the United States (US) and Puerto Rico from 17 February 2017 to 30 March 2017.|A total of 1000 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study.
716182|NCT03077165||
716183|NCT03076996||
716184|NCT03076983||
716185|NCT03076970||Crossover study with three study periods, participants were randomly allocated to one of six treatment sequences: ABC, ACB, BAC, BCA, CAB or CBA as per the dosing sequence in each period with 6 days washout period.
716186|NCT03076515||
716187|NCT03076359||
716188|NCT03076190||4 participants declined to participate; 127 were randomized
716189|NCT03075904||This study was terminated after the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy were characterized at a single dose level (10 milligram/kilogram [mg/kg]) in Cohort 1, before any participants were enrolled in Cohort 2. This results disclosure is for Cohort 1 only.
716190|NCT03075891||
716191|NCT03075878||This study was terminated after the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy were characterized in Cohort 1 (SYNT001 Dose 1), before any participants were enrolled in Cohort 2 (SYNT001 Dose 2). This results disclosure is for Cohort 1 only.
716192|NCT03075839||
721817|NCT02420327||
716197|NCT03075410|This was a double blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of single and repeat doses of GSK3036656 in healthy adult participants. The study was conducted at 1 center in United Kingdom from 02-April-2017 to 04-August-2017. Part A was a crossover design, Part B was a parallel group design..|20 participants screened, 8 were screen failures (SF). 9 were randomized at the beginning of Part A. During Part A, 2 of the 3 participants who withdrew were replaced, hence 11 randomized. 30 participants screened, 7 were SF, 4 passed screening but were kept in reserve, hence 19 randomized in Part B.
716198|NCT03075163||
716199|NCT03074682||
716200|NCT03074630||
716201|NCT03074500|Recruitment period was March 2017-May 2017 Setting: A university hospital outpatient clinics|Number of patients assessed for eligibility was 41. Among them,8 participants were excluded due to being inappropiate for the inclusion criteria (2 had concomittant radiculopathy, 2 were diagnosed as cubital tunnel syndrome, 2 were diagnosed as carpal tunnel syndrome and 2 of them had duration of symptoms were more than 12 weeks)
716202|NCT03074409||
716203|NCT03074331|Participants were enrolled at study sites in India. The first participant was screened on 23 March 2017. The last study visit occurred on 07 February 2018.|170 participants were screened.
716204|NCT03074162|This was an open-label, randomized, 3-treatment periods (each of which included a multiple-dose period of 7 days [twice daily and only in the morning on Day 7] and two pharmacokinetic profile periods of 12 hours [Day 1] and 24 hours [Day 7]) separated by a wash out period of at least 7 days.|All subjects were screened for eligibility to participate in the trial. Subjects attended the trial site and it was ensured that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
716205|NCT03073876|Of 25 individuals enrolled, 2 participants allocated to the placebo group discontinued: one complained of side-effects (n = 1); one moved from NY area (n = 1). Total N= 23.|
716206|NCT03073798||
716207|NCT03073759||
716208|NCT03073486||
716209|NCT03073213|All the re-enrolled participants from single dose period (SDP) to multiple dose period (MDP) have been washed out and screened for eligibility to MDP.|
716210|NCT03073200|"Results reported are for primary outcome up to week 12, data beyond week 12 will be reported after final analysis.
~Participants (Pts)"|Open-Label Etanercept group occurred only in Etanercept approved countries.
716211|NCT03073148||Upon enrollment in the study, patients received Hydra-PEG coated fluorosilicone acrylate RGP contact lenses. Assignment to the Tangible Boost or Control group occurred after 1 month of contact lens wear, on day 30. 4 participants that did not report back for visit 3 on day 30 were excluded from the study prior to assignment to a group.
716212|NCT03073109|The study included participants from two Latin American countries (Colombia and Peru) from 15 March 2017 to 16 September 2019.|This was a non-interventional, hybrid study (prospective and retrospective data collection).
716213|NCT03072875||
716214|NCT03072732|Patients were recruited at the dialysis clinics of three sites, from November 2016 through February 2017.|
716215|NCT03072719|Participants were recruited at a single center in Ireland.|Total 394 participants were screened, out of which 120 participants were randomized. 274 participants were not randomized because 248 participants did not meet the study criteria, 4 participants were lost to follow up, and 7 participants withdrew the consent and 15 participants for other reasons (not-specified).
716216|NCT03072550||
716217|NCT03071887|The three open pilot groups and qualitative exit interviews were conducted between December 2017 and July 2018 through community outreach, flyers, and referrals from healthcare providers at the Infectious Disease units of two Boston-area hospitals.|
716218|NCT03071744||
716219|NCT03071276|Participants must have a diagnosis of AML and must have disease that has relapsed or is refractory to chemotherapy, or that has relapsed after hematopoietic stem cell transplantation (HSCT).|
716220|NCT03071263||
716221|NCT03070964|"The first IC was signed on 25Oct2016 and the first study treatment administration was on 9Nov2016.
~The cutoff date was 2Jul2018 (date of last follow-up, clinical cutoff). At cutoff date, 14 patients had been included, of whom 13 were treated and evaluable for safety, and 12 were evaluable for the primary efficacy endpoint"|
716222|NCT03070782|Participants with a clinical diagnosis of hyperlipoproteinemia(a) and established CVD were enrolled in 31 study centers in United States, Canada, Denmark, Germany and Netherlands between 7th March 2017 to 13th November 2018.|286 participants were randomized in a 1:1:1:1:1 ratio to Cohorts A, B, C, D or E. In each cohort, participants were randomized in a 5:1 ratio to receive ISIS 681257 or placebo.
716223|NCT03070730||Participants that were enrolled in the study were excluded from the study because they either did not meet eligibility criteria or decided not to participate.
716224|NCT03070548||This is a mass balance study with 14C-radiolabeled talazoparib in at least 6 participants with advanced solid tumors who qualified for treatment with talazoparib. Participants who completed the mass-balance part in this study had the option to continue treatment on an open-label extension protocol.
716225|NCT03070483||
716226|NCT03070470||
716227|NCT03070431||
716228|NCT03070236||
716229|NCT03070171|Randomised, single-dose, open-label, replicate design in a two-treatments, four-period, two-sequence crossover design (T:Dabigatran etexilate tablet formulation 110 mg and R: Dabigatran etexilate capsule formulation 110 mg)|All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
716230|NCT03070002|The study opened for enrollment on March 23, 2017 with an accrual goal of 42 patients. The first patient started treatment on study October 19, 2017. The study closed permanently to enrollment on March 6 2018 with one patient enrolled, due to low accrual and before total accrual to the study could be met.|
716333|NCT03053180|A total of 60 participants signed the written patient authorization form and were enrolled into the study in 7 investigational sites located in Russia.|
716334|NCT03053063|Participants were enrolled at study sites in North America, Asia, Australia, New Zealand, Europe and Puerto Rico. The first participant was screened on 30 January 2017. The last study visit occurred on 06 May 2019.|2154 participants were screened.
716231|NCT03069989|The study was conducted at 3 sites in the United Kingdom from 13-June-2017 to 18-July-2018. At the interim analysis following review of Cohort 1 data it was agreed to stop the study without proceeding into optional Cohort 2.|A total of 11 participants were screened, of which 3 were screening failures. Two screening failure participants did not meet inclusion/exclusion criteria and 1 participant withdrew consent. Hence, 8 participants were enrolled in this study.
716232|NCT03069677||
716233|NCT03069482||
716234|NCT03069365||Intent to treat population: all participants who received at least 1 dose of study drug
716235|NCT03069352|Participants were enrolled at 76 sites globally. The study is currently ongoing; the results reported below include the primary analysis for efficacy which was conducted after 133 deaths occurred (data cut-off date of 15 February 2019), and an unplanned 6-month follow-up update for overall survival and safety (15 August 2019 cut-off date).|Participants with acute myeloid leukemia (AML) were randomized to one of two treatment arms in a 1:2 ratio (placebo + low-dose cytarabine [LDAC] or venetoclax + LDAC). Randomization was stratified by AML status (secondary, de novo), age (18 - < 75, ≥ 75) and region (United States [US], European Union [EU], China, Japan, rest of world).
716236|NCT03069313|we needed at least a total of 30 patients to achieve more than 85% power to detect the differences in BPI-SF pain scores relative to baseline using a two tailed paired t-test with 5% level of significance. After accounting for 15% dropouts, we estimated to include at least 35 patients in the study.|IRB approved recruitment of 50 participants
716237|NCT03068897||
716238|NCT03068767|Chronic HBV patients receiving regular 6-month surveillance in the outpatient clinic of Taipei Tzu Chi Hospital were invited to join the study from August 2017 to September 2018.|All had positive hepatitis B surface antigen (HBsAg) for more than 6 months. Those with positive anti-hepatitis C virus (HCV) antibody, other known causes of chronic hepatitis or receiving antiviral treatment currently were excluded. Those who had HBsAg loss, undetectable HBV DNA and adequate vitamin D level (≥30 ng/mL) were excluded.
716239|NCT03068754||Of 207 potential participants screened, 143 were randomized to begin treatment
716240|NCT03068611|Study recruitment was conducted online over 7 weeks (May to July, 2017). Only newly registered users of BecomeAnEX.org were recruited.|
716241|NCT03068468|Participants were enrolled at 89 investigative sites in the United States, Australia, Austria, Canada, France, Germany, Greece, Italy, Japan, Republic of Korea, Russia Federation, Spain and United Kingdom from June 01, 2017 to February 07, 2020.|A total of 490 participants with Progressive Supranuclear Palsy disease were enrolled and randomised in the study. Of these, 486 participants received the study drug in placebo-controlled (PC) period. After completing PC period, 416 participants entered and dosed in open-label extension (OLE) period and no participants completed the study due to early termination of the study.
716242|NCT03068312||This study was conducted in participants with cystic fibrosis (CF).
716243|NCT03068091||
716244|NCT03067987||
716245|NCT03067948||We only enrolled an intervention group (and utilized a historic control). Thus, all patient participants were assigned to the intervention group.
716246|NCT03067506|Participants took part in the study at 1 investigative site in the United Kingdom from 29 February 2017 to 03 July 2017.|Participants with a diagnosis of major depressive disorder (MDD) prescribed first-, second- or third-line antidepressant monotherapy were provided with an Apple watch on which brief cognitive and mood tests were evaluated.
716247|NCT03067441||After successfully completing 52 weeks of treatment in the parent study, Study 1002-040 (NCT02666664), and meeting entry criteria, participants could enrol into this Open-label Extension (OLE) study.
716248|NCT03066999||No enrolled patients were excluded from the study before assignment to groups
716249|NCT03066778||Of the 453 randomized participants, 446 received ≥1 dose of treatment. One participant who was randomized to the pembrolizumab+etoposide arm was inadvertently treated with placebo+etoposide. For efficacy analyses this participant will be included in the arm they were initially randomized into and for safety analyses the participant will be included by treatment received. No participants entered the optional second course phase.
716250|NCT03066622||
716251|NCT03066609|A total of 664 patients were screened and 543 patients were randomized to one of three treatment groups in the induction period: secukinumab 300 mg (n=272), secukinumab 150 mg (n=136), and placebo (n=135)|
716252|NCT03066193||
716253|NCT03066102||
716254|NCT03065933||
716255|NCT03065530|Parturients (>18 and <45 years old) with a singleton pregnancy admitted to our institute who underwent elective caesarean delivery under epidural anaesthesia were recruited in this study between February 2017 and October 2017.|"not meeting inclusion criteria (n=39)
~declined to participate , n=14
~other reasons, n=3"
716256|NCT03065283||none declare
716257|NCT03065205||
716258|NCT03065075||
716259|NCT03065023||
716260|NCT03064841|Patients were recruited into the study in the order of their clinical visits scheduled. First 7 consented and suitable patients were recruited for each site on each day, or fewer if without enough patients. One study visit was planned for each patient.The data was collected for this study from 09th March, 2017 to 30th December, 2017.|All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be included in the study if any of specific entry criteria was violated.
716261|NCT03064451||
716262|NCT03064126||A total of 440 subjects were enrolled in the trial (376 subjects in the RCT, 52 subjects in the LB substudy and 12 subjects in the PK substudy). RCT subjects were randomized to Ranger DCB or standard PTA at a 3:1 ratio, respectively. All LB and PK subjects were treated with the Ranger DCB. RCT/PK shows 12 months data; LB shows 6 month data.
716263|NCT03064113|21-May-2011 (FPFV) through 07-Oct-2011 (LPLV)|Male and female subjects between the ages of 40 and 75 years-old with a clinical diagnosis of COPD and responsiveness to ipratropium bromide.
716264|NCT03063476|Healthy subjects (N=2) were recruited in March 2017. Subjects who had previously participated in a pilot study were invited to return for an additional study visit.|
716265|NCT03063437|Participants were recruited at the listed tertiary academic hospitals from August 15, 2017 to September 30, 2018.|
716266|NCT03063385||
722055|NCT02400749||
722056|NCT02400710||
716267|NCT03063294|We recruited and enrolled VA primary care clinics from October 2016 to June 2018 using a multi-pronged approach, including teleconference presentations and direct outreach to regional and national leadership. Enrolled clinics participated in a 12-month quality improvement project.|"Patient survey data were collected cross-sectionally at baseline and 12-months' follow-up to measure clinic outcomes. For the primary outcome (Health Care System Hassles Scale), both baseline and follow-up data are presented in the outcomes section; the primary measure of effectiveness depends on the change in outcome from baseline to follow-up."
716268|NCT03063086||
716269|NCT03062917||
716270|NCT03062891||A total of 240 participants gave informed consent. After consent, participants were required to complete the baseline assessments before being assigned to a group. A total of 41 participants did not fill out this survey despite consenting, meaning a total of 199 participants were assigned to a group.
716271|NCT03062605||
716272|NCT03062488|"Place of Study: Nemours Children's Hospital, Orlando, FL and Wolfson Children's Hospital, Jacksonville, FL
~Design:
~Prospective Randomized Study Study Period: October 2017-March 2018 Population: 50 pediatric patients in each group between 24 months through 7 years of age undergoing adenoidectomy or tonsillectomy with or without adenoidectomy"|No events. Patients were screened prior to pre-enrollment.
716273|NCT03062267||No significant events to report that occurred after participant enrollment but prior to assignment of participants to an arm.
716274|NCT03062228|Participants were recruited between April 28 2016 through February 22 2017, inclusive. Participants were recruited by the study recruiter from a sample of healthy, Ghanaian women presenting to the KBTH maternity wards and who delivered a live birth within the past 48 hours.|There were no significant events in the study after participant enrollment but prior to assignment to an arm or group. Two participants who were recruited were excluded from the study after it was discovered later that they did not fully meet the eligibility criteria (both had delivered stillborn infants).
716275|NCT03061513|Recruited from the clinical practice at Weill Cornell Medicine's (WCM) Parkinson's Disease Department as well as Weill Cornell Medicine, and utilized flyers.|One screening visit consisting of: neurological examination, interview on health topics, and questionnaires on health topics.
716276|NCT03061331|A total of 20 subjects were enrolled in this cross-over study.|
716277|NCT03061279||
716278|NCT03061214|"The trial was conducted at 65 sites in 5 countries/regions as follows:
~Region China: 42 sites; Brazil: 3 sites; Republic of Korea: 12 sites; South Africa: 5 sites; Ukraine: 3 sites."|
716279|NCT03061188|Opened for accrual on May 23, 2017 with goal of 50 patients. Due to funding issues the goal was reduced to 15. First patient started treatment June 1, 2017. Study design for Phase 1 was 3 + 3 escalation. The study closed Aug. 5, 2019 with accrual for the study design having been met.|
716280|NCT03061175||
716281|NCT03061097|We enrolled patients across four nursing homes from July 10, 2017 to June 30, 2018. A total of 78 individuals were consented for enrollment. A total of 33 individuals were able to provide a stool sample of sufficient quantity to perform all the required screening and stool collection for autologous FMT preparation prior to randomization. These 33 were eligible for randomization.|From the 33 participants eligible for randomization, a total of 7 were randomized to receive either active autologous FMT or placebo. Of the other 25 individuals (out of 78) consented to the study, 14 withdrew (3 of which withdrew post-randomization and 11 of which were withdrawn prior to assignment).
716282|NCT03060759||
716283|NCT03060551|Between July 2018 and December 2019, a total of twenty subjects were enrolled in this single center, open label, phase I trial.|Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection.
716284|NCT03060512|Study was performed in 53 sites in the United States. First subject first visit: 2 March 2017. Last subject completed: 23 August 2017. The entire planned duration of study participation was up to 7 weeks.|350 subjects were screened and 74 subjects failed to meet the inclusion/exclusion criteria. 276 subjects were randomised to a treatment sequence.
716285|NCT03060486||
716286|NCT03059901||
716287|NCT03059810|A total of 72 subjects were enrolled into this study. Of the enrolled subjects 63 were dispensed at least one study lens and 9 did not meet the eligibility criteria. All 63 dispensed subjects completed the study.|
716288|NCT03058991|Of 124 consented individuals, 108 were randomized and attended at least 1 session.|
716289|NCT03058705||
716290|NCT03058692|Participants were healthy adult males and non-pregnant females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09APR2018 and 28JUN2018.|
716291|NCT03057704|Subjects were approached after they were scheduled for colonoscopy or minor procedures and appeared in the holding area for procedures in which propofol sedation or induction of general anesthesia was used.|
716292|NCT03057613||
716293|NCT03057496|Subjects were recruited between January 2018 and May 2019 via referrals from the Carroll Center for the Blind, the Massachusetts Commission for the Blind and practitioners at vision rehabilitation clinics in the Greater Boston area, and via a pool of volunteers who had previously participated in studies in our lab.|
716294|NCT03057366|Participants took part in the study at 1 investigative site in Hungary from 11 May 2017 to 05 November 2018.|Participants with advanced solid tumors were enrolled in this two-part study to receive intravenous infusion of pevonedistat in Part A and pevonedistat in combination with chemotherapy in Part B (optional part). One participant from Part A consented for Part B but did not meet the eligibility criteria and never received study treatment in Part B.
716295|NCT03057132||
716296|NCT03056573|A total of 64 subjects were enrolled and undergone implant with a Portico Transcatheter Aortic Valve via an alternative access route at 10 sites between March 29, 2017 and June 04, 2018.|Of the 64 subjects, 45 subjects were implanted via subclavian/axillary access and 19 via transaortic access. Enrollment in the transaortic arm was stopped after 15 months due to a slow enrollment rate. All subjects will be followed through 1-year post implant.
716335|NCT03053050|Participants were enrolled at study sites in North America, Asia, Europe, Australia, South America, Puerto Rico, and New Zealand. The first participant was screened on 13 February 2017. The last study visit occurred on 19 June 2019.|2250 participants were screened.
722057|NCT02400580||
716297|NCT03056456|For the time between consecutive periods, participants continued their CSII with their personal pump using Insulin lispro (Humalog) until the evening of Day -1 (after administration of the standardized dinner) of the next period when they will receive either LY900014 or Insulin lispro (Humalog), according to assigned treatment.|Participants were randomized to receive LY900014 and Insulin lispro (Humalog) via CSII with intermittent bolus doses, standard single-wave (SS) and standard dual-wave (SD) immediately before meals, over 3 days per period.
716298|NCT03056352||
716299|NCT03056300|Recruitment occurred from January 2017 to April 2017 across 4 sites.|This was a single-arm study where all enrolled patients would have their surgery performed using the powered vascular stapler.
716300|NCT03056144||One participant was recruited and assigned for the intervention.
716301|NCT03056040||Participants were stratified into 1 of 2 groups based on their transfusion history. Stratified participants were randomly assigned in a 1:1 ratio to receive ravulizumab or eculizumab.
716302|NCT03055988|Randomised, double-blind, active-controlled, two-period cross-over study in patients with chronic obstructive pulmonary disease (COPD) to investigate effect of 6-week treatment of tiotropium + olodaterol fixed dose combination (FDC) with fluticasone propionate + salmeterol FDC orally inhaled by the Respimat® and Accuhaler® inhaler respectively.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensured that all patients met all inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
716303|NCT03055897|Participants were recruited from one investigative site located in the United States.|This reporting group includes all enrolled participants.
716304|NCT03055858|A total of 50 subjects were enrolled in the ADO II AS IDE study at 8 centers in the United States between 5 June 2017 and 25 January 2018. Following completion of enrollment in the IDE cohort, an additional 150 subjects were enrolled in the continued access protocol (CAP) between 26 March 2018 and 1 February 2019.|Among the 50 subjects in the IDE cohort, 4 subjects did not receive the study device and were withdrawn per protocol following completion of the 1-month follow-up visit. Of the 150 subjects in CAP cohort, 139 completed the 6 months follow up.
716305|NCT03055832||
716306|NCT03055806||
716307|NCT03055650|Participants were recruited from 3 investigative sites located in the United States.|This reporting group includes all enrolled participants.
716308|NCT03055624|Patient were recruited in Interventional Radiology clinic from April 2017 to August 2018.|All patients enrolled were treated in the single treatment arm.
716309|NCT03055494|A total of 133 patients were screened for the study, with 82 (61.7%) of these completing the screening phase.|This is The Randomized Set; i.e., all randomized participants
716310|NCT03055338||
716311|NCT03055260||
716312|NCT03055221||
716313|NCT03055195|This study investigated the efficacy and safety of mepolizumab administered subcutaneously (SC) in adults with moderate to severe atopic dermatitis. A total of 34 participants were enrolled at different centers in Canada and United States.|This study was terminated early, as this study reached pre-determined futility criteria following interim analysis.
716314|NCT03055156|Participants were recruited from individuals who were scheduled for an overnight PSG study as part of their regular care at the Stanford Sleep clinic.|4 participants were enrolled but not randomized to a study arm.
716315|NCT03055000||
716316|NCT03054922||
716317|NCT03054857||
716318|NCT03054844||
716319|NCT03054805|This trial is expected to recruit 180 children, but the actual willingness to participate in the trial is 153 children.|
716320|NCT03054740||
716321|NCT03054649|This study was conducted at 1 site located in the Philippines and 1 site located in Mexico. Of the 44 subjects signing an informed consent, 12 failed to meet inclusion/exclusion criteria and 5 were withdrawn prior to implantation when the intraocular lens power was not available due to inventory restrictions.|This reporting group includes all implanted subjects/eyes. Note: One eye in Cohort 2 attempted implantation but was discontinued due to capsular instability (preferred term: Ciliary zonular dehiscence), which was reported as an intraoperative SAE.
716322|NCT03054506||"52 patients signed the consent form and thus were considered enrolled. 4 failed screening 48 passed screening
~5 withdrew before run-in
~1 lost to follow-up 42 started run-in
~2 failed run-in 40 randomized
~1 withdrew due to AE 39 completed study
~1 patient's follow-up CTT data irretrievable (technical malfunction) 38 complete CTTs"
716323|NCT03054428|The study was conducted at 45 sites in the United States and Canada between 21 Mar 2017 and 05 Jun 2018. A total of 295 participants were screened, of which, 251 were eligible. The most common causes for screening failures were lack of adequate disease severity and lack of willingness to comply with study visits and procedures.|Eligible participants were randomized (1:1:1) & stratified by baseline Investigator's Global Assessment (IGA) score (3 vs 4) & body weight (<60 kg vs ≥60 kg) to 16 wks treatment with dupilumab every 2 wks (q2w) or q4w,or placebo q2w.
716324|NCT03054103||
716325|NCT03054077||
716326|NCT03054064||
716327|NCT03054051|Participants were recruited from schools in Kisumu Town, western Kenya, Africa. Enrollment of participants occurred between March 20, 2017 and April 7, 2017. All study activities were completed by June 19, 2017.|Letters were sent to 150 parent of age-eligible children inviting them to attend informational meetings. Of the 126 who attended a meeting, 90 were interested and eligible to participate and 60 of these were randomly selected to enroll in the study.
716328|NCT03053960||
716329|NCT03053518||
716330|NCT03053492||
716331|NCT03053427|Participants with moderate to severe idiopathic restless legs syndrome were enrolled in 51 study sites in Japan.|Participants received single-blind placebo for 1 week (run-in period). Subsequently, eligible participants were randomized to receive gabapentin enacarbil or placebo orally once daily after dinner for 12 weeks (treatment period).
716332|NCT03053401|Potential subjects will be seen in the orthopedic office prior to the scheduled surgery. An informed consent will be provided for review by the authorized legal representative (s). If they agree to participate in the study, they will be requested to sign and date the informed consent.Patient ascent to the study may be also requested if needed.|
719934|NCT02595450||It was physician's decision to prescribe erlotinib in participants and to document their treatment cycles.
716338|NCT03052725|A total of 392 patients with severe eosinophilic asthma rolled over from Study 30025 or 30027, and 391 of these patients (at 125 centers) were enrolled into this extension study and treated with reslizumab. One patient withdrew consent after completing Study 30025 and before enrolling in Study 30066.|Of the 391 patients enrolled, 112 (29%) enrolled seamlessly and 279 (71%) enrolled non-seamlessly, meaning there was a time gap between completion of the parent study and start of this extension study.
716339|NCT03052530||
716340|NCT03052517|Participants were from ARG, AUS, AUT, BEL, BRA, BGR, CAN, CHN, COL, CZE, EST, FIN, FRA, DEU, GRC, GTM, HUN, IND, ISR, JPN, LVA, LBN, LTU, MYS, MEX, NLD, PER, PHL, POL, ROU, RUS, SAU, SRB, SGP, SVK, ESP, CHE, TWN, TUR, GBR, USA|Eligible patients included patients completing a prior QAW039 Phase 3 study (CQAW039A2307, QAW039A2314, CQAW039A2316, or CQAW039A2317) and patients who had not previously participated in a QAW039 study.
716341|NCT03052426||
716342|NCT03052322||Participants were randomized in 1:1 ratio to receive either MSB11022 or EU-Humira for 48 weeks.
716343|NCT03052257||
716344|NCT03051646||
716345|NCT03051633||
716346|NCT03051607|The disposition of study patients. A total of 66 patients were enrolled in 27 study centers across 6 countries: USA, United Kingdom, Italy, Canada, Spain and Hungary, and were included in the Safety Set (SS) as well as the Full Analysis Set (FAS).|
716347|NCT03051217|The study started to enroll patients in February 2017 and concluded in January 2019.|"The study included a 5 Week Screening Period, an Initial Period up to Week 16, a Maintenance Period up to Week 52 and a Safety Follow-up Period up to Week 60.
~Participant Flow refers to the Randomized Set (RS)"
716348|NCT03051165|Participants were recruited from the Emory Sleep Center in Atlanta, Georgia. Enrollment began on 11/21/2016 and the study was terminated early on 12/14/2017.|
716349|NCT03051100||
716350|NCT03050918||
716351|NCT03050775||
716352|NCT03050697|Subjects were recruited from one investigative site located in New Zealand.|Of the 16 subjects (25 eyes) enrolled in the study, 4 subjects (7 eyes) were exited prior to implantation as screen failures, and 1 eye in 1 subject was exited prior to implantation due to a medical condition. This reporting group includes all implanted subjects (12) and eyes (17).
716353|NCT03050619||All study participants had at least 12 months of continuous registration in the United Kingdom (UK) Clinical Practice Research Datalink (CPRD) prior to the study initiation which is a data source comprising primary care electronic medical record (EMR).
716354|NCT03050541||
716355|NCT03050398|All patients had to have met all eligibility criteria and to have been enrolled into the CLEE011A2404 core study. Patients were offered the opportunity to consent and enroll into this optional companion study.|
716356|NCT03050372|Eligibility screening was completed over the phone by trained sleep personnel; sleep laboratory is located at the Medical University of South Carolina's Institute of Psychiatry at 67 President St., Charleston S.C. This is a crossover study; each participant is exposed to both active and sham conditions.|N=209 subjects screened from 07/2016-07/2017; N=193 participants were excluded prior to PSG because they declined to participate (N=49), did not meet the age criterion (N=28), did not meet the sleep criterion (N=61), had co-morbid psychiatric disorders (N=42), or for other reasons (N=13); N=4 excluded after consent due to medication/baby/no-show.
716357|NCT03050359|Participants took part in the study at 52 investigative sites in China, Korea, and Taiwan from 05 April 2017 to 19 July 2019.|Participants with or without diagnosis of Helicobacter pylori (H. Pylori) Infection were enrolled and randomly assigned in 1:1 ratio to receive either TAK-438 20 mg or lansoprazole 30 mg along with matching placebo (to keep the blind).
716358|NCT03050320||
716359|NCT03050294||
716360|NCT03050216||
716361|NCT03050203||
716362|NCT03049852||
716363|NCT03049748||A total of 68 subjects were recruited and screened for study eligibility based on inclusion/exclusion criteria. Of these, 28 were excluded due to not meeting the study criteria (n=10) or refused to participate due to being overwhelmed with the newly implanted LVAD (n=15) and other reasons (n=3).
716364|NCT03049501||
716365|NCT03049488|Healthy adults were recruited from the Washington, D.C., metropolitan area.|
716366|NCT03049280|Recruitment of study subjects occurred between April 2017 and October 2017 at 3 participating sites|
716367|NCT03048747|This trial was conducted in 16 participants from 31 trial sites in Japan.|"Adults with a definite diagnosis of SIADH in reference to Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011"
716368|NCT03048500|The first patient started treatment July 12, 2017. The study was designed to enroll patients with/without prior PD-1/PD-L1 inhibitor treatment. The study closed enrollment to patients without prior treatment with PD-1/PD-L1 inhibitor April 30, 2018. The study was suspended for IA and subsequently closed to further enrollment August 13, 2019.|
716369|NCT03048383|Patients were prospectively enrolled from July 2012 to March 2015. All patients 18 years and older with facial synkinesis, who presented to our tertiary care Facial Nerve Center for treatment and were appropriate candidates for botulinum toxin chemodenervation therapy, were offered voluntary participation.|Exclusion criteria included previous complication from botulinum toxin neuromodulator injection, inability to understand or complete the SAQ survey, inability to participate in follow-up, and pregnancy. Informed consent was obtained from each patient before enrollment in the study.
716370|NCT03048058|20 subjects male/female aged 18 years and older with the diagnosis of persistent erythema associated with mild to moderate rosacea as defined by an Investigator Global Assessment rating between 2 and 5. Patients were recruited from Wake Forest University Department of Dermatology Clinics and via Institutional Review Board approved advertising.|
716371|NCT03048006||
716372|NCT03047720||
716373|NCT03047551||Subjects were excluded from the analysis due to study withdrawal prior to receiving sonography.
716374|NCT03047447||
716375|NCT03047174||
716376|NCT03046472||
716377|NCT03046446||
716378|NCT03046225|The study was carried out at the Hospital de Clínicas de Porto Alegre Hospital (HCPA), Rio Grande do Sul, Brazil. Evaluations and interventions occurred between May and September 2016.|
718242|NCT02770612||1 individual met exclusion criteria after agreeing to participate, due to postoperative length of stay > 7 days, and was not consented
716379|NCT03046212|The study was carried out at the Hospital de Clínicas de Porto Alegre Hospital (HCPA), Rio Grande do Sul, Brazil. Evaluations and interventions occurred between May and August 2016.|
716380|NCT03045926|35 subjects with chronic functional diarrhoea were enrolled into this open label study in 2 study centres in the Netherlands and United Kingdom. The first subject started 24 August 2016 and last subject completed 9 May 2017.|73 subjects were screened for inclusion in the study, 38 subjects failed screening, and 35 met all the inclusion and none of the exclusion criteria. All 35 subjects received treatment with study medication.
716381|NCT03045887|This is a two part, single site, randomized, double-blind (sponsor open), placebo controlled study in healthy smokers. Study was conducted in the United Kingdom.|Part A comprised of two cohorts, each of which consisted of 3 treatment periods with 4 treatment sequences. Out of 98 screened participants, 37 were randomized, 58 were screen failures and 3 were retained as reserve participants. In Part B, 12 participants were included, 11 of them were taken from Part A and 1 additional participant only for Part B
716382|NCT03045861|This was a dose ranging study to evaluate the antiviral effect, safety, tolerability and pharmacokinetics of cobicistat-boosted GSK2838232 monotherapy over 10 days in human immunodeficiency virus-1 (HIV-1) infected participants.|A total of 85 participants were screened across 21 sites in the United States and Canada of which 52 participants failed screening. Thirty three participants were enrolled from 15 sites in the United States and Canada.
716383|NCT03045809|At risk women regardless of symptoms were enrolled between 7-2016 and 3-2017. Recruitment activities were implemented by study staff with the help of community mobilizers. They organized recruitment meetings, and distributed flyers. Women were encouraged to refer their friends.|Women were eligible if aged 18 or older, and at risk of sexually transmitted infections (more than one sex partner and/or having been treated for at least one STI in the past year), with or without urogenital symptoms. HIV-positive and pregnant women were not excluded. Women were screened free of charge but did not receive a monetary reimbursement.
716384|NCT03045653||
716385|NCT03045302|Subjects with acromegaly were recruited from 26 January 2017 in 4 study centres in 4 countries. Stage 1 of the study consisted of a twice daily (BID) regimen of BIM23B065, and a Stage 2 with a three times daily regimen of BIM23B065 was planned but not conducted due to early termination of the study on 26 May 2017.|7 subjects were screened and 3 failed screening (1 subject did not meet eligibility criteria and 2 subjects did not complete screening procedures due to the early study termination).
716386|NCT03045081||A controlled, sequential, nonrandomized study design was used. For first 6 months of enrollment, assessment procedures for the control group were conducted, during which the Web-based PTSM platform for the intervention phase of the study was developed. During the second 6 months, patients were enrolled in the intervention group.
716387|NCT03044886||
716388|NCT03044730|The study opened for enrollment on May 25th, 2017 with an accrual goal of 30 patients. The first patient started treatment on May 30th, 2017. The study closed permanently to further enrollment on March 12th, 2018 as the accrual goal was met.|
716389|NCT03044691||
716390|NCT03044574|The total amount of 812 patients were screened during the enrollment period, 405 of them were excluded: Caprini score of <11 (n=304); a various regimen of anticoagulation (n=48); venous thrombosis at the baseline (n=31); declined participation (n=18); implanted inferior vena cava filter (n=4).|
716391|NCT03044431|All patients who underwent elective, investigational cell therapy were enrolled in the outcomes study.|No patients in the study received placebo. All patients received autologous, adult stem cell therapy.
716392|NCT03044353|This was an open label, non-randomized, monthly repeat anti-serum amyloid p component (anti-SAP) treatment study in systemic amyloidosis participants with cardiac dysfunction caused by cardiac amyloidosis.|Twelve participants were screened; seven were enrolled in to study (six were enrolled in Group 1 and one in Group 2). No participant was enrolled in Group 3. The study was terminated by sponsor due to a change in the benefit:risk profile of GSK2315698+GSK2398852 (anti-SAP treatment).
716393|NCT03044197||
716394|NCT03044106||
716395|NCT03044028||
716396|NCT03043885||
716397|NCT03043651||
716398|NCT03043599||
716399|NCT03043560|Participants recruited from Sept 2017 through August 2019|
716400|NCT03043534||
716401|NCT03043365|Thirty-seven healthy volunteers were recruited from June 2017 through March 2018 at the National Institutes of Health (NIH) (Bethesda, MD)|
716402|NCT03043274|Patients were recruited in the cardiac catheterization laboratory.|Patients were randomized upon recruitment to the standard of care alone or standard of care in addition to cangrelor
716403|NCT03043105||
716404|NCT03043079||
716405|NCT03042910||Study was conducted in 4 countries from 07-Nov-2016 to 18 Dec 2017.
716406|NCT03042780||
716407|NCT03042715||
716408|NCT03042702||"No participants were enrolled in the Kevetrin 350 mg/m2 IV/Cohort 2 Arm/Group."
716409|NCT03042559||
716410|NCT03042299|Participants took part in the study at 1 investigative site in Japan from 10 February 2017 to 11 March 2017.|Healthy male participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive TAK-536 10 milligram (mg) granules (pediatric formulation) or TAK-536 10 mg tablet (commercial formulation).
716411|NCT03041909|Subjects enrolled in this study participated in GBT440-001 study (NCT02285088).|There was no screening period as subjects transitioned directly from the GBT440-001 study (NCT02285088).into this study.
716412|NCT03041896||
716413|NCT03041792||Overall, a total of 61 potential participants were randomized to the study, and 60 of them received study treatment.
716414|NCT03041467|330 subjects from 21 US sites and 8 OUS sites contributed to the global cohort. 204 of subjects came from U.S. sites, 112 of subjects came from Japan sites, and 14 of subjects came from New Zealand sites. There was no minimum enrollment requirement at each site; individual sites were not allowed to enroll more than 20% of the total study subjects.|A total of 488 patients were consented to be reviewed for enrollment. 158 patients were not enrolled in the study. 170 subjects were randomized to IN.PACT AV Drug Coated Balloon treatment and 160 subjects were randomized to the Standard PTA Treatment.
716415|NCT03041441||
716416|NCT03041298||
716417|NCT03041181||
718243|NCT02770547||
716418|NCT03041116|The study was conducted in Spain, United States, Canada, Czech Republic, France, Germany, Italy, Norway, and Poland from 17-July-2017 to 23-December-2019. A total of 91 participants were screened, of which 84 participants were randomized in the double blind period, and 78 participants completed the double-blind period.|The study consisted of a screening period of up to 29 days. All assessments at screening were done as per the schedule of assessments.
716419|NCT03041090||
716420|NCT03040713|Enrollment occurred between Apr 2017 and Oct 2018.|As a result of a positive amyloid scan at screening, 1 subject was discontinued prior to administration of flortaucipir. Two additional subjects had positive amyloid scans and received flortaucipir, but were excluded from the per protocol population results (n=13).
716421|NCT03040687|Sixty healthy adult naive subjects enrolled and received one of the three BSIgG products. Fifty-nine of those subjects were challenged with ETEC strain B7A.|Study specific screening occurred prior to enrollment. Eighty-two subjects signed study specific consent forms. Nineteen subjects screened failed. Three subjects were randomized but did not receive BSIgG.
716422|NCT03040479||Male and female adult participants with normal hepatic function, mild and moderate hepatic impairment participated in the study. All participants participated in one treatment period and received a single dose of lasmiditan in the fasting state.Participants confined to the clinic 10 hours prior to dosing until 36 hours after drug administration.
716423|NCT03040466||
716424|NCT03040362||Participants were preceded by an overnight fast (at least 10 hours) from food (not including water) before receiving a dose of [14C]-lasmiditan.
716425|NCT03040336||
716426|NCT03040323|Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. The PI has left the institution and no information is available regarding how many participants Started and Completed the study in each arm|
716427|NCT03040011||After enrollment but before randomization, 4 patients withdrew from the study: surgical location changed (n=1), declined to participate (n=1), unsafe for general anesthesia (n=1), reported lidocaine allergy (n=1). Because they withdrew prior to randomization, we received permission to enroll an additional 4 patients to meet goal sample size of 75.
716428|NCT03039738||
716429|NCT03039699||
716430|NCT03039686||
716431|NCT03039621||
716432|NCT03039569||
716433|NCT03039543||
716434|NCT03039283|162 participants were recruited in five German centres from March 2017 to August 2018|
716435|NCT03039192||
716436|NCT03039179|The study began on May 2014 and ended in May 2015 when the eighties patient was enrolled.|
716437|NCT03039088||
716438|NCT03038867||
716439|NCT03038815||
716440|NCT03038126||
716441|NCT03038113||
716442|NCT03037983|Of the approached potential participants, many were unable to participate due to difficulties with the amount of time required to participate in the study, or a change in interest.|
716443|NCT03037905||
716444|NCT03037619||
716445|NCT03037580||
716446|NCT03037541||
716447|NCT03037489||
716448|NCT03037307|All participants were recruited at a single center in the United States.|A total of 53 participants were screened. Out of which 44 participants were randomized in the study. 9 participants were not randomized because they did not meet the study criteria.
716449|NCT03037203||
716450|NCT03036852|Participants were enrolled at study sites in Canada, the United Kingdom, Spain, Israel, New Zealand, and Australia. The first participant was screened on 22 March 2017. The last study visit occurred on 07 November 2018.|78 participants were screened.
716451|NCT03036839|Participants were enrolled at study sites in Taiwan, Italy, Germany, the United States, and Belgium. The first participant was screened on 27 June 2017. The last study visit occurred on 14 February 2019.|124 participants were screened.
716452|NCT03036735||Study was terminated prematurely
716453|NCT03036384|All participants were recruited at CHU Saint-Pierre.|Possible doses of HB prilocaine range from 30 to 55mg, but actual administrated doses will be defined by CRM
716454|NCT03036293||
716455|NCT03036215||
716456|NCT03036163||
716457|NCT03036124||
716458|NCT03036072||
716459|NCT03035955||
716460|NCT03035942||
716461|NCT03035929||1 participant withdrew after consent but before the baseline visit and is not included in the results.
716462|NCT03035916||According to the analysis by PASS 11.0, at lease 25 participants each arm were needed.Taking into account the withdrawal of patients in the middle of the study, each group were more than a few included
716463|NCT03035864|Eligible patients were randomized in a 2:1 ratio to rhNGF eye drops solution at 20 μg/ml (120 patients) or vehicle eye drops solution (60 patients) 6 times per day for 8 weeks, followed by 4 weeks of follow-up with no further treatment.|
716464|NCT03035760|Participants were healthy adult males and non-pregnant females recruited from existing volunteer populations and from the communities at large around the clinical site. Participants were enrolled between 05JUN2017 and 10APR2018.|
716465|NCT03035708||
716466|NCT03035487||
716467|NCT03035032|Asian male participants above the age of 18 years with biopsy-proven prostate adenocarcinoma who fulfill the eligibility criteria were enrolled in this study.|107 participants were enrolled and 106 participants received treatment.
716468|NCT03034967|This study investigated the dose response and safety of danirixin compared with placebo in Chronic Obstructive Pulmonary Disease (COPD) participants with respiratory symptoms including cough, increased sputum production and dyspnoea.|A total of 614 participants were randomized in this study across 9 countries.
716469|NCT03034954||Two participants were excluded after consent due to failing the tDCS safety screen. One participant endorsed a skin condition with lesions at site of electrode placement. One participant disclosed a prior head injury.
716470|NCT03034928|Subjects were recruited from 1 study center located in the United States (US).|All 33 subjects enrolled were randomized. This reporting group includes all randomized subjects (33).
719935|NCT02595437||
719936|NCT02595372||
719937|NCT02595073||
716471|NCT03034915|In this randomized, double-blind, double dummy, 3-arm parallel group study, eligible participants received Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 microgram (mcg) once daily via the ELLIPTA dry powder inhaler (DPI), or UMEC 62.5 mcg once daily via ELLIPTA DPI, or Salmeterol (SAL) 50 mcg twice daily (BID) via the DISKUS DPI (1:1:1) for 24 weeks.|A total of 3591 participants who met the eligibility criteria were screened; 2431 participants were randomized and 2425 comprised the Intent to Treat (ITT) population (6 participants randomized in error and did not receive any treatment).The study consisted of a run-in period (4 weeks), treatment period (24 weeks) and follow up period (7+/-3 days).
716472|NCT03034772||Since multiple centers were enrolling simultaneously, two more patients then anticipated were randomized
716473|NCT03034577|In the period from June 2017 until November 2018, 350 patients were enrolled across 4 hospital sites (100 patients from the Royal Melbourne Hospital, 98 from the Peter MacCallum Cancer Centre, 88 from the Royal Women's Hospital and 64 from North Park Private Hospital).|No participants were excluded from the study prior to surgical procedure
716474|NCT03034460|This study was conducted at six centers in three countries (Germany, France, Canada) between 25 April 2016 (first participant screened) to 02 November 2016 (last participant completed).|A total of 70 participants were randomized, of which 64 participants completed the study.
716475|NCT03034057||A total of 169 adult women participants of reproductive age (18 to 45 years) were enrolled in the study.
716476|NCT03034044||
716477|NCT03033745||
716478|NCT03033511||
716479|NCT03033134||
716480|NCT03032965||Two subjects were not randomized.
716481|NCT03032523|Mothers attending obstetrics clinics at Stanford University were approached if they met inclusion criteria. 119 mothers were approached, 66 declined to participate, 23 were lost to follow up after initially discussing the study, 6 were unable to participate because research staff were not available at the time of birth, and 3 were ineligible.|
716482|NCT03032510||
716483|NCT03032393||
716484|NCT03032380|The study population included participants with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative bacteria.|Participants were randomized in a 1:1 ratio to either cefiderocol or meropenem. Randomization was performed by the stratified randomization method using infection diagnosis (HABP, VABP, and HCABP) and Acute Physiology and Chronic Health Evaluation II (APACHE II) score (≤ 15 and ≥ 16) as allocation factors.
716485|NCT03032263||
716486|NCT03031899|patients were recruited from the outpatient department of the dental college where the study was conducted.|3 patients were excluded as one patient had not quit the habit and in another patient the lesion regressed during 2 weeks waiting period post habit cessation
716487|NCT03031795||
716488|NCT03031678||
716489|NCT03031496|This is a Phase I, open label, balanced, randomized, single dose, two-way crossover study, enrolling 42 healthy participants at a single center in South Africa.|Total 42 participants were enrolled and randomized to receive a single oral dose of study treatment in a cross-over manner.
716490|NCT03031431||
716491|NCT03031340||
716492|NCT03030989||
716493|NCT03030638|Participants recruited in the study are those patients who received a first dispensing for single-agent formulations of olodaterol or indacaterol during the study period and had at least 12 months of continuous enrolment in the study databases prior to index date.|Databases used: PHARMO Database Network in the Netherlands, National Registers in Denmark and IMS Health Information Solutions Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France. Study periods were 01 March 2014 - 31 December 2016 in PHARMO and Denmark and 01 October 2015 - 30 November 2017 in the IMS RWE LPD panels.
716494|NCT03030599||Subjects were evaluated for eligibility during the Screening Period (up to 30 days).
716495|NCT03030183||
716496|NCT03029988||
716497|NCT03029832||
716498|NCT03029819||
716499|NCT03029780||
716500|NCT03029715||
716501|NCT03029650|"Recruitment was conducted at the University of Iowa by advertisements in the Noon News, a UIHC newsletter, and by a mass email that was sent to all staff/faculty/and students. Recruitment began in November 2016 and continued until the enrollment goal of 24 participants completing all arms of the study was reached in March 2017."|
716502|NCT03029624|Participants were recruited and enrolled from April 2017 to September 2017 (i.e. 5 months). The study took place at 7 urology/urogynecology clinics across the United States and New Zealand.|Participants were required to complete a 2-week washout of all overactive bladder medications prior to baseline. After passing screening and baseline criteria, patients were enrolled. As this is a single-arm study, once participants were enrolled they were assigned to the intervention (eCoin).
716503|NCT03029234|This study was conducted at 18 centers in China. The study is ongoing; results are reported as of the data cut-off date of 15 March 2019, which was conducted when all enrolled participants had received at least 12 cycles of treatment or had discontinued treatment.|
716504|NCT03029091|Participants were recruited from eosinophilic esophagitis specialty clinics (3 sites) in the USA between May 2017 and April 2019.|17 participants screened, 2 excluded (2 met exclusion criteria), and 15 initiated the intervention
716505|NCT03029000||A total of 6 participants were screened for this study, of which 5 participants were considered a screen failure mainly due to inclusion criteria not met or exclusion criteria met. Only one participant was enrolled and treated in this study.
716506|NCT03028987|Volunteers are past participants who are identical twins and who have been identified as HLA DR1501+ or DR0701+ by lab assay results.|All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .
716507|NCT03028974|Participants are presented only in the group in the year in which they received the vaccination. Planned Groups B and C did not enroll in years 2014-2018, Group A did not enroll in 2015-2018 and Group F did not enroll in years 2016-2018 due to LAIV not being recommended.|
716508|NCT03028896||
716509|NCT03028870|First subject first visit: 14-Mar-2017; last subject last visit: 21-Nov-2017. Thirty-one investigative centers in the United States participated in the study.|
716510|NCT03028636||
716511|NCT03028467|This study was conducted to assess pharmacokinetics (PK), safety, tolerability and efficacy of GSK3196165 for 12 weeks, in combination with Methotrexate (MTX), in Japanese participants with active moderate-severe rheumatoid arthritis (RA) despite treatment with MTX. Participants were enrolled at 15 centers in Japan from 24-Jan-2017 to 30-Jun-2017.|A total of 35 participants were screened, and 20 participants failed screening because of not met eligibility criteria (18 participants) and withdrawal by participant (2 participants). Hence, a total of 15 participants were enrolled and randomized to study treatment.
716512|NCT03028363||
716513|NCT03028324||
716514|NCT03028220||
716515|NCT03028142||74 were screened.Main reasons for screen failure were reversibility criteria not met (21), withdrew consent (5) and unsuitable chronic obstructive pulmonary disorder (COPD) history (4). Patients had to discontinue long acting bronchodilators on the day before screening and short acting bronchodilators for 8 hours before all spirometry assessments
716516|NCT03028129|Eligible participants were interviewed for eligibility criteria (age, race, alcohol use, comorbidities) and laboratory tests (HIV, hepatitis B and C, liver enzymes, interferon gamma dosing for tuberculosis antigens and active tuberculosis).|Study was discontinued at ninth month after interim analysis and showed efficacy in intervention group less than 2.5%
716517|NCT03028025||
716518|NCT03028012||
716519|NCT03027661||
716520|NCT03026803||
716521|NCT03026556|This is a Non-interventional retrospective cohort study based on existing data with propensity score matching (PSM) in Non-valvular Atrial Fibrillation (NVAF) patients with new Non-Vitamin K antagonist oral anticoagulant (NOAC) use.|The study was a US retrospective database of the Department of Defense (DoD) beneficiary population. Data was extracted from July 1, 2010 to June 30, 2016. Thus there was no pre-assignment/screening details.
716522|NCT03026530||
716523|NCT03026283|From 1/24/2017 to 6/13/2018 patients seen in the Cardiology ambulatory care service for CCTA to be evaluated for the diagnosis of obstructive disease, and who were evaluated as low to intermediate risk for obstructive disease, and who were symptomatic were offered the opportunity to participate in the study.|To participate, patients were required to complete the CCTA, and on exam have no Cardiac stenting or bypasses as determined by medical history provided by the patient and review of CCTA scan.
716524|NCT03026257|Subjects were recruited from 8 study centers located in the United States (5), Germany (2), and Canada (1).|Of the 323 enrolled, 66 subjects exited as screen failures prior to randomization. An additional 5 subjects were randomized but discontinued prior to treatment. This reporting group includes all randomized and exposed subjects (252). Subject distribution in As Randomized and As Treatment differs due to 3 subjects with lens/solution misallocations.
716525|NCT03026166|Participants were enrolled at 17 clinical study sites in 4 countries: United States, France, Italy, and Germany.|Three study cohorts were planned to enroll approximately 30 participants in each, including a dose-limiting toxicity (DLT) evaluation phase (the first 12 weeks of any treatment for all participants) and an expansion phase. However, Cohort 2 was limited to 12 participants and Cohort 3 was not opened.
716526|NCT03026088||
716527|NCT03026075|"patients indicated for screening/ surveillance or diagnosis colonoscopy enrolled at 3 clinical sites as follows:
~Radboud University Medical Center(UMC)- Netherlands-16 cases
~Erasmus Medical Center (MC)-Netherlands-16 cases
~Mainz University Medical Center(UMC)-Germany- 15 cases
~enrollment period : 20 December 2016 - 31 May 2017"|The patients had reduced preparation in order to mimic poor bowel cleansing. the study bowel preparation consisted of dietary restrictions (no dried fruit, seeds or nuts) starting 2 days prior to colonoscopy, a 24-hour clear liquid diet and a split dose of 20 mg Bisacodyl (10 mg in each dose).
716528|NCT03025945||
716529|NCT03025217||
716530|NCT03024970||
716531|NCT03024606||23 patient were randomized to the texting group and 26 to the control. However, 9 in the texting group and 10 in the controls did not follow up for any study procedures of data collection, so we do not have data to report on them.
716532|NCT03024112||
716533|NCT03023891||25 participants signed consent, 5 did not show up for screening and 2 failed screening. 18 participants started the study.
716534|NCT03023878|"This study was conducted at 12 centers in the European Union (France, Germany, Spain, and the United Kingdom), the United States, and Canada.
~Of the 54 subjects screened, 47 subjects were enrolled."|The study consisted of a standard of care rituximab-chemotherapy Run-in Period of approximately 21 weeks, a 12- to 16-week blinatumomab Treatment Period, a 30-day safety follow-up, and a Long-term Follow-up Period up to 1 year from the first dose of blinatumomab, or until participant death, whichever occurred first.
716535|NCT03023709|The study was halted after the IIV pilot phase because the LAIV vaccine for the study phase was not recommended for use by ACIP so no participants enrolled in the LAIV study phase.|
716536|NCT03023683||
716537|NCT03023553||
716538|NCT03023488||
716539|NCT03023423||A total of 100 participants were enrolled in the study (7 in phase 1b [safety run-in phase], and 93 in Phase 2 [randomized phase]). Among them, 99 participants (7 in phase 1b [safety run-in phase], and 92 in phase 2 [randomized phase]) were randomized as 1 participant was randomized after the clinical cutoff date (17-May-2018).
716540|NCT03023176||
716541|NCT03023137|Recruitment started on May 2011 and was stopped on April 2015.|Of 491 patients approached, 11 declined participation in the study and 480 were enrolled. Participants in the W+D arm were recommended lifestyle changes to be started when they wished to conceive. Only participants in both groups who managed to get pregnant were included in the study.
716542|NCT03022981|Participants were enrolled at 28 study sites in Belgium, Italy, the United Kingdom, and the United States. The first participant was screened on 26 January 2017. The last study visit occurred on 26 February 2020.|221 participants were screened.
716543|NCT03022916||Each patient served as their own control. One big toenail received nail polish only and the other big toenail was treated with nail polish and efinaconazole solution.
716594|NCT03016325||100 participants in Part I and 222 in Part II were assigned to treatment (322 randomized in total), of which 97 and 214, respectively, were treated (311 total treated). Reasons not treated (Part I): 3 other reasons. Reasons not treated (Part II): 2 no longer met study criteria; 1 adverse event (AE); 5 other reasons.
719938|NCT02595008||
722058|NCT02400463||
716544|NCT03022799|A first in human, single center, randomized, placebo controlled, double blind, sequential group Phase 1 study in healthy subjects recruited from Nov 2016 to Sep 2017. Participants who met all the inclusion and none of the exclusion criteria were enrolled.|All subjects underwent a Screening period of up to 28 days and a 3 day Confinement period when they were hospitalized for study activities (Day -1 to Day 3) for Part A (Single Ascending Doses) and an 8 day Confinement period when they were hospitalized for study activities (Day -1 to Day 8) for Part B (Multiple Ascending Doses)
716545|NCT03022630||
716546|NCT03022526||We aimed to have 46 participants completing the trial, so enrolled until we hit that mark (greater than 46 enrolled due to loss to follow up).
716547|NCT03022435|Numbers listed in the tables reflect individual twins and not twin pairs.|
716548|NCT03022422|Numbers listed in the tables reflect individual twins and not twin pairs.|
716549|NCT03022396|All numbers of participants reflect an individual participant, not a twin pair. All enrollment numbers reflect the number of participants, not the number of twin pairs.|
716550|NCT03022370||
716551|NCT03022084||
716552|NCT03022045||A total of 18 subjects were enrolled; 1 subject failed screening and are excluded from the analyses.
716553|NCT03021759|No informed consent was obtained from the participants in this study.|
716554|NCT03021668||
716555|NCT03021642||Overall, 65 subjects were screened for this study. Of which, 24 subjects were randomized into the study.
716556|NCT03021564||31,399 patients were admitted to intensive care unit (ICU), 24,245 were discharged alive without in-ICU cardiac arrest, 6,477 died in the ICU with no cardiopulmonary resuscitation (CPR) attempt, 677 had cardiac arrest with CPR attempt.
716557|NCT03021538||
716558|NCT03021343||
716559|NCT03021304|Participants with severe eosinophilic asthma, were enrolled at 4 sites in the United States of America, 3 sites in the Netherlands, 3 sites in the Russian Federation, 3 sites in Sweden, and 2 sites in Canada. The study duration lasted from 01 February 2017 to 08 August 2017.|Of the total 58 participants screened, 2 were screen failures and 56 were enrolled in this open-label, single arm, repeat dose study of mepolizumab and attempted to self-administer at least one dose of study treatment.
716560|NCT03021265|This was an observational study based on newly collected data under real-world practice in participants with hypertension in Japan.|Non-randomized, post marketing surveillance, a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline concomitant drug in use) were defined for participant enrollment. Participants were enrolled from February 2017 to January 2018 (The first existed in Jan, system opened with delay on Feb).
716561|NCT03021187|The trial was conducted at 111 sites in 9 countries: Canada (7), France (10), Greece (6), India (9), Japan (18), Mexico (2), Poland (4), Russian Federation (5) and United States (48). Following sites were approved by the IRB/IEC but didn't randomise subjects: France (2), India (1), Japan (1) and United States (3).|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
716562|NCT03021018|The study started to enroll patients in February 2017 and concluded in April 2018.|Participant Flow refers to the Intent-to-Treat as Treated (ITT-T) Set.
716563|NCT03021005||
716564|NCT03020992|The first participant was enrolled in December 2016 and the last participant was enrolled in December 2017.|"The study included 3 periods as follows: Period 1 (Screening Period) 1 to 5 weeks before Baseline, Period 2 (Treatment Period) Week 0 to Week 96 and Period 3 (FU Period) 10 weeks from the final dose of investigational medicinal product (IMP) received (Week 104).
~Participant Flow refers to the Safety Set."
716565|NCT03020745|This was a Phase 2a study examining the first administration of GSK3389404 in participants with chronic hepatitis B (CHB). The study was conducted in 2 parts- Part 1 (dose escalation) and Part 2 (dose expansion and optional follow-up period).|A total of 106 participants were screened, of which 78 participants (12 participants in Part 1 and 66 participants in Part 2) were enrolled and received either GSK3389404 or placebo. No participants were enrolled in two cohorts of Part 1 (GSK3389404 60 milligram [mg] and GSK3389404 240 mg) as per decision made by the dose escalation committee.
716566|NCT03020719||
716567|NCT03020576||
716568|NCT03020537||
716569|NCT03020524||
716570|NCT03020498||
716571|NCT03020472||
716572|NCT03020446||
716573|NCT03020160||A total of 7 patients were screened and enrolled in the PK run-in cohort of the study. For the expansion cohort, a total of 44 patients were screened, of whom 41 were enrolled.
716574|NCT03020095||
716575|NCT03020069||
716576|NCT03020004||
716577|NCT03019783||
716578|NCT03019744||
716579|NCT03019627|After confirmation of inclusion and exclusion criteria all eligible patients were randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up. rhNGF and vehicle were administered as eye drops at 20 μg/mL concentration, six times daily for 8 weeks in patients with dry eye|
716580|NCT03019549||11 participants completed Period 1 but did not enter Period 2 because they did not meet the genotype criteria.
716581|NCT03019458||
716582|NCT03018938||
716583|NCT03018691||
716584|NCT03018340||In Stage 1, pts were randomized to pimavanserin or placebo (1:3). At the end of Stage 1, placebo pts not responding to treatment were rerandomized (1:1) in Stage 2; all other pts continued in Stage 2 the initial randomized treatment.
716585|NCT03018223||
716586|NCT03018106|Participants were enrolled between June 2017 and September 2017|One individual gave informed consent to participate in the study and was randomized to the Estrogen arm.
716587|NCT03018028|The trial was conducted at 16 sites in Japan. Japanese participants with type 2 diabetes (T2D) treated with either diet and exercise alone or with oral anti-diabetic drug (OAD) monotherapy for at least 30 days prior to screening were enrolled in the study.|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
716595|NCT03016078|Investigation period: Feb 2017 - March 2017. The study was conducted on 21 enrolled subjects at one site in the US. Subjects included were 18 years, and above, undergoing elective primary hip or knee arthroplasty.|
716596|NCT03015649||
716597|NCT03015220|The trial was conducted at 36 sites in Japan.|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
716598|NCT03015181|Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.|
716599|NCT03015142||
716600|NCT03014700||
716601|NCT03014674|This was a randomized, multi-center, open-label, parallel-group, single-dose study in healthy participants. The participants were administered one of 3 different mepolizumab treatments (a liquid drug product in a safety syringe; a liquid drug product in an autoinjector; a reconstituted lyophilized drug product from a vial).|A total of 246 participants were randomized and 244 participants received study treatment. Two participants were randomized in error
716602|NCT03014492||
716603|NCT03014479|Participants took part in the study at 25 investigative sites in Japan, from 18 February 2017 to 21 October 2017.|Participants with a historical diagnosis of type 2 diabetes mellitus on diet and exercise therapy only, were enrolled in 1 of 2 treatment groups (Trelagliptin once-weekly, or the Daily DPP-4 inhibitor once- or twice-daily (according to individual label instructions), orally, for up to 12 weeks).
716604|NCT03014453|"The cohort study was conducted with BPD infants born≤32 weeks gestational age (GA) between January 2017 and July 2018 at Shengjing Hospital of China Medical University.The BPD was diagnosed at 36 weeks postmenstrual age (PMA) on the National Heart, Lung and Blood Institute classification and categorized as mild, moderate or severe."|
716605|NCT03014206||
716606|NCT03014180|Subjects have been included from Feb 16, 2017 to June 2, 2017.|All the 60 patients were assigned to the treatment arm.
716607|NCT03014011|37 participants were screened between May 2017 and July 2018 at the Department of Endocrinology, Bispebjerg University Hospital, Denmark.|Of the 37 screened participants, 28 met inclusion criteria and were randomised. 25 completed both intervention visits. Three participants (one man, two women) withdrew from the study after randomisation for reasons not related to the intervention. Baseline characteristics are based on the 25 participants that completed the study.
716608|NCT03013985||Out of 247 consented, 9 were not randomized, 27 failed to start (19 did not receive study medication, 1 had eGFR out of range, 7 had admission BG >400 mg/dl)
716609|NCT03012841||
716610|NCT03012828||
716611|NCT03012334||Crossover study with five study periods, each participant received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and Placebo as per the dosing sequence in each period. The washout period between dosing in consecutive study periods was at least 7 days.
716612|NCT03012191||
716613|NCT03012061|This study was conducted at different centers in Russia, United States, Canada, Poland and Romania to compare the efficacy, safety and tolerability of two doses of umeclidinium bromide (UMEC) administered once-daily (OD) via a dry powder inhaler, versus placebo.|Total 421 participants were included in the study.
716614|NCT03011840||
716615|NCT03011099||One participant dropped out of the study after signing the consent before randomization.
716616|NCT03011034|Out of 34 enrolled participants, 33 participants received daratumumab and 1 participant received talacotuzumab.|Due to serious infusion-related reaction (IRR) event that occurred in first participant enrolled in talacotuzumab arm, no further participants were enrolled in this arm.
716617|NCT03010800||
716618|NCT03010631|All participants were recruited in the United States|"Treatment periods for Cohorts 1 and 2 did not have the same participants.
~Participants in each cohort were randomized to sequence.
~In each sequence the first treatment was given for 14 days, there was a 7-day washout period, and then the second treatment was given for 14 days."
716619|NCT03010501|Children aged 3 to 5 years old were recruited from classrooms at three childcare centers in State College, PA by distributing letters to parents between September 2016 and September 2017.|
716620|NCT03010423||
716621|NCT03010254|Subjects were recruited from 21 investigative sites located in Australia, Canada, Spain and the United Kingdom.|A total of 322 subjects were enrolled in the study, out of which 39 subjects exited due to screen failure and 1 subject discontinued due to site being closed before actual screening visit and randomization. This reporting group includes all randomized subjects.
716622|NCT03010137||
716623|NCT03009162||
716624|NCT03008889||Screening method for classifying self-injurious behavior (SIB) was before randomization.
716625|NCT03008837||27 veterans were initially consented. However, 6 of these veterans either could not begin the study within the study period, moved out of state, or received implanted MRI-incompatible devices that excluded them from the study following the initial consent, but prior to randomization.
716626|NCT03008707||
716627|NCT03008213||
716628|NCT03008174||
716629|NCT03007966||
716630|NCT03007719|This study was closed due to low accrual. Only 4 patients were enrolled to this protocol and all were assigned to cohort 2|
716631|NCT03007472||
716632|NCT03007394||
716633|NCT03007225|Recruitment finished and study completed Patients collected from HCC clinic full filling the inclusion criteria,Ain Shams University hospitals|
716634|NCT03006926|Participants took part in the study at 24 investigative sites in the United States, Japan, United Kingdom, France, Italy, Spain, and Russian Federation. Results in this summary are reported based on the primary completion date (31 October 2019) of study.|A total of 104 participants were enrolled and received treatment. Of these, 6 participants were enrolled in DLT part and 98 were enrolled in the expansion part.
716635|NCT03006562||
716636|NCT03006471||
716637|NCT03006458||
716693|NCT02998021||
716694|NCT02997904||
716695|NCT02997735||
716696|NCT02997722||
716697|NCT02997163||
716698|NCT02996968||
722059|NCT02400437||
722060|NCT02400346||
716638|NCT03006341|A validation study; Patients from a United States health insurance database (linked to electronic medical records (EMR) in a subset) with a recorded diagnosis of atrial fibrillation without evidence of valvular aetiology and at risk for stroke who initiate dabigatran or warfarin between October 2010 and December 2014.|In this non-interventional study based on existing data, no patients were screened.
716639|NCT03005288|The study was completed as planned.|Participants were randomized to the study at 1:1 ratio to receive BYM338 10 mg/kg or placebo.
716640|NCT03005067|Participants were recruited from 24 centers in United States.|A total of 308 participants were screened for this study, out of which137 participants were screening failure.
716641|NCT03005041|Participants were recruited at a single center in United states of America (U.S.A)|A total 58 participants were screened, out of which 56 participants were enrolled in the study. Two participants were not enrolled as they did not meet the study criteria. Of 56 enrolled participants, 55 participants were randomized as one participant withdrew consent.
716642|NCT03004924|Study was conducted at 121 centers in 14 countries between 29 Mar 2017 (first participant first visit) and 01 Oct 2018 (last participant last visit).|A total of 1080 participants were screened, of them 753 enrolled and randomized to treatment. One participant was randomized in error and therefore captured only in the intent-to-treat (ITT) population.
716643|NCT03004911||
716644|NCT03004846|Participants with chronic stable plaque psoriasis were recruited in this 2 part study to evaluate safety, tolerability and clinical effect of GSK2981278.|A total of 10 participants were screened; of which two were screen failures and eight were included in the treatment phase of Part A and received GSK2981278 4% ointment for 8 weeks. Part B of this study was not conducted as pre-defined efficacy criteria for continuing to Part B were not met. Hence no participants were enrolled in Part B.
716645|NCT03004638|The study was conducted at 4 sites in the USA between 23Jan2017 and 02Nov2017.|A total of 91 participants were screened, of which 32 participants were randomized in a 6:2 ratio to receive MEDI6012 or placebo in 4 cohorts (8 participants in each cohort). For Cohort 4, randomization happened in a 7:1 ratio to receive MEDI6012 or placebo due to an interactive voice/web response system programming issue.
716646|NCT03004534||The screening period starts with registration (which is informed consent signature) and ends when the patient is enrolled (following eligibility central review confirmation by TRIO) or screen failed.
716647|NCT03004469|Study was conducted in 5 countries, in 52 sites and initiated on 02 Aug 2016 (First participant first visit) and the study got completed on 05 Mar 2018 (Last participant last visit).|A total of 632 participants were screened, with 458 participants being randomized.
716648|NCT03003793||
716649|NCT03003520|Participants were recruited from 12 investigational sites in the U.S. Austria, Germany and Great Britain.|Data are reported as of the database cutoff date of 02-Aug-2018. Forty-six participants signed consent, and 40 had a baseline and post baseline evaluation.
716650|NCT03003494|"Patient with chronic Obstructive Pulmonary Disease receiving treatment Spiolto® Respimat® were enrolled between July 2017 and May 2018.
~309 screened and 3 patient violated inclusion/exclusion criteria were excluded, 306 entered the trial"|All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met. Physical Functioning patient questionnaire (PF10)
716651|NCT03003390|One participant in the enoxaparin group was enrolled during a single arm phase and not included in the analysis.|
716652|NCT03003000|This was a randomized, placebo and active-controlled, double-blind, 3-arm, parallel trial, comparing the effect of the fixed dose combination of 400 milligram (mg) ibuprofen&100 mg caffeine versus 400 mg ibuprofen and placebo in patients with acute neck or back pain randomly assigned in 2:2:1 ratio respectively.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered/randomised to trial treatment if any one of the specific entry criteria were not met.
716653|NCT03002974||
716654|NCT03002818||
716655|NCT03002753|Participants were recruited between December 2016 and June 2018.|
716656|NCT03002623||
716657|NCT03002610||
716658|NCT03002454|Oncologic bone imaging subjects screened and enrolled at Health Sciences Centre, Winnipeg, Manitoba from August to November 2017.|Previous bone imaging scan, within 3 to 28 days, using fission derived 99mTc MDP Injection to act as comparator for investigative drug (neutron-bombardment derived 99mTc MDP Injection) bone imaging scan of same subject.
716659|NCT03002311|The enrollment period for the study took place between January 1, 2016 and June 30, 2017.|Of 933 patients screened, 35% were enrolled. Of those screened, 4.5% of patients were excluded because they did not have a phone and 2.0% were excluded because they were non-English speaking. The largest groups excluded were those who did not want to participate (n=300) and those who were given a specific referral (n=107).
716660|NCT03002194||
716661|NCT03002077|The study was planned to be terminated when 100 patients had completed the 52-week Open Label Treatment Period (OLTP).|Patients who either completed the RAP-MD-04 Double-blind Treatment Period (DBTP) or who did not meet criteria to be randomized into the DBTP of RAP-MD-04 and were therefore discontinued from that study were eligible for Study RAP-MD-06.
716662|NCT03002038||
716663|NCT03002012||
716664|NCT03001778||
716665|NCT03001674|10 patients with advanced HF from 2014 to 2015 at Tufts Medical Center referred for clinically indicated RHC and IABP placement prior to LVAD surgery. Five control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.|
716666|NCT03001557|Participants took part in the study at 57 investigative sites in the United States, Japan and United Kingdom from 20 Dec 2016 to 26 Jul 2018 (Results are reported based on the primary completion date of 26 July 2018).|A total of 214 participants were screened, of which 151 were screen failures and 63 were randomized and enrolled in to the study. Of these 63 participants, 62 received the study treatment (1 participant was inadvertently randomized but did not receive any study drug).
716667|NCT03001453||
716668|NCT03001258||
716813|NCT02979444||All enrolled participants were randomized to one of the three study arms
729993|NCT01795833||
716669|NCT03001219|Adult men and women with moderate to severe active rheumatoid arthritis (RA) who experience an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy with MTX plus anti-TNF-a therapy.|"Arms are not mutually exclusive.
~Proof of Concept: 109 total participants enrolled.
~Extension Period Analysis: 106 participants from the previous groups, including placebo, received 360 (n=9) or 810 mg/dose (n=97) of RO7123520.
~Part 3 was not conducted due to early study termination."
716670|NCT03001076|Out of the 269 participants who were randomized to the double-blind treatment period, 181 participants were randomized to bempedoic acid and 88 participants to placebo. One participant in the placebo group was randomized but never started treatment.|The study consisted of an approximate 1-week screening period, a 4-week single-blind placebo and ezetimibe run-in period, and a 12-week double-blind treatment period.
716671|NCT03001011|Study was conducted at 38 centers in China. A total of 482 participants were screened between 07 June 2017 & 30 May 2019, of which 280 participants were screen failures. Screen failures were mainly due to serum phosphorus level greater than or equal to >=5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per litre [mmol/L]) at screening visit.|A total of 202 participants were randomized in the study. Randomization was stratified according to screening serum phosphorus level (>=5.5 - 6.0 mg/dL [1.78 - 1.94 mmol/L] and >6.0 mg/dL [1.94 mmol/L]). Assignment to arms was done centrally using interactive voice/web response system in 1:1 ratio (Renvela [sevelamer carbonate]: placebo).
716672|NCT03000686|Healthy participants who met the eligibility criteria entered a 2-period crossover study. Participants were randomized to either placebo or GSK2586881 in each Treatment Period. Total duration of participation was 8 weeks. Study was terminated for technical feasibility, operational considerations and futility in line with pre-specified criteria.|A total of 48 participants were screened, of which 31 failed screening and 17 (11 participants in Part 1 and 6 in Part 2) were enrolled in the study. The study was conducted at a single center in Germany.
716673|NCT03000673||32 participants were randomized and treated.
716674|NCT03000608||
716675|NCT03000569|Participants were enrolled at 9 sites in the United States and took part in the study which ran from 30 November 2016 to 11 September 2017.|
716676|NCT03000530|In Part A, 21 participants were screened; 13 received at least one dose of study drug. In Part B, 169 participants were screened; 89 received at least one dose of study drug.|
716677|NCT03000452|The study was conducted at 8 sites in 4 countries including Greece, Spain, Sweden and the United States, from 14 March 2017 to 04 December 2017|Eligible participants included those with relapsed and refractory multiple myeloma (RRMM) who progressed on daratumumab (DARA) while on a DARA-containing regimen as the most recent multiple myeloma (MM) therapy. Participants had to have received at least 3 prior anti-myeloma therapies.
716678|NCT03000309||
716679|NCT03000283|Participants were recruited based on physician referral at a single medical institution between March 1, 2017 and November 7, 2018. The first participant was enrolled on March 22, 2017 and the last participant was enrolled on November 7, 2018.|
716680|NCT03000088|This study enrolled patients scheduled for elective surgery requiring orotracheal intubation in our hospital. The last patient completed in August 2016.|
716681|NCT03000075||A total of 182 subjects were enrolled; 11 subjects failed screening and are excluded from the analyses.
716682|NCT02999763||
716683|NCT02999672||
716684|NCT02999633|The study was conducted in 6 countries. A total of 16 participants were screened of those 2 participants failed screening: 1 participant for evidence of ongoing infection and 1 participant for not meeting the criterion for relapsed or refractory T-acute lymphoblastic leukemia (ALL)/T-lymphoblastic lymphoma (LBL).|The first participant was enrolled on 14 March 2017. A total of 14 participants were enrolled to receive isatuximab. The study was early terminated on 08 Nov 2017 due to an unsatisfactory benefit/risk ratio.
716685|NCT02999178|Randomized (1:1 ratio), placebo-controlled, double-blind, parallel-group trial comparing nintedanib to placebo over a 52-week treatment period (Part A). Participants continued on blinded, randomized treatment beyond 52 weeks (Part B). Data base lock (DBL) one was on 6-June-2019, DBL two was on 11-September-2019. Overall Study Period=Part A and B.|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
716686|NCT02999100|This is a 2 part study: Part 1 enrolled pregnant women, randomized to receive either inhaled (IH) or intramuscular (IM) oxytocin as active management of the third stage of labor. Part 2 enrolled non-pregnant women of childbearing potential and received IH oxytocin and intravenous (IV) oxytocin in a cross over design.|A total of 31 participants were enrolled in the study. This study was terminated due to inability to reliably measure plasma oxytocin levels in women in third stage labor, regardless of administration method (IH, IM or IV).
716687|NCT02998996||
716688|NCT02998684||
716689|NCT02998671|A total of approximately 75 subjects were planned to be enrolled in the study. The study was terminated early due to futility after a total of 52 subjects were enrolled and randomized.|"For period 1 (12 weeks) subjects were randomized to one of the 3 treatment groups CJM112 high dose, CJM112 low dose or placebo.
~For Period 2 (12 weeks) subjects treated with Placebo in Period 1 were rerandomized to CJM112 high dose or CJM112 low dose. All other subjects remained on the same dose."
716690|NCT02998554|The study was conducted at 30 centers in the United States and Puerto Rico between 28 March 2017 (first participant first visit) and 16 May 2019 (last participant last visit).|A total of 156 participants were randomized and received the treatment. Out of them, 134 participants completed the study.
716691|NCT02998541|This study was conducted at 97 sites in 15 countries between 27 March 2017 (first participant enrolled) to 13 May 2019 (last participant completed).|A total of 219 participants were randomized and 196 completed the study. Among which 219 were included in intent-to-treat (ITT) population, 217 in safety population, 83 in modified intent-to treat (mITT) population. Two participants were included in ITT population but not in safety population.
716692|NCT02998476|A Phase 2, multicenter, international, open-label study with approximately 120 planned participants with relapsed or refractory DLBCL.|55 participants included in the treatment group A who were not previously treated with a BTK inhibitor and received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW. 5 Participants were enrolled in group B who were previously treated with a BTK inhibitor. and received parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW.
716699|NCT02996682|Participants were enrolled at study sites in Japan. The first participant was screened on 26 December 2016. The last study visit occurred on 08 May 2018.|155 participants were screened.
716700|NCT02996591||
716701|NCT02996500||
716702|NCT02996474||
716703|NCT02996448||Healthy volunteers were not enrolled to the study due to the early termination. The three subjects enrolled were those with AD-HIES.
716704|NCT02996097||
716705|NCT02995980||
716706|NCT02995967||Although 3 participants completed the study, no analysis done due to study being stopped for poor enrollment.
716707|NCT02994979||
716708|NCT02994940||
716709|NCT02994732||
716710|NCT02994251||
716711|NCT02994108|Study recruitment took place from January through early September 2018 in the Chicago area.|Although 155 participants completed the baseline survey, only 150 of them were randomized. A double screening protocol was used to ensure participants who had already been vaccinated were not accidentally enrolled. Five participants reported receiving a dose of HPV vaccine on baseline so they were no longer eligible for the RCT.
716712|NCT02994056|Participants were enrolled at study sites in the United States and France. The first participant was screened on 23 January 2017. The last study visit occurred on 12 December 2018.|73 participants were screened.
716713|NCT02993926|Participants took part in the study at 6 investigative sites in China from 24 Jun 2017 to 30 Sep 2018.|Participants with a diagnosis of central precocious puberty (CPP) who previously received Enantone for at least 9 continuous months in clinical practice index period: 1 September 1998 to 30 September 2018 were enrolled in this study.
716714|NCT02993783|Participants took part in the study at 11 investigative sites in the United States, France, Belgium and Norway from 28 April 2017 to 09 May 2018.|Participants with steroid-refractory acute intestinal graft-versus-host disease (GvHD) who had undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) were enrolled to receive 300 mg or 600 mg vedolizumab.
716715|NCT02993757|Study participants were enrolled from 01 December 2016 to 16 April 2017 at 5 centers in Malaysia. A total of 528 participants were enrolled and randomized in study.|As per protocol amendment 1, only dengue immune participants at baseline completed the dengue vaccination schedule and received 3 doses of CYD dengue vaccine, whereas the dengue non-immune participants received only 2 doses of CYD dengue vaccine. All participants were followed for safety up to 6 months after the last vaccination.
716716|NCT02993471||Multicenter, open-label, 2-period, fixed-sequence study.
716717|NCT02993445||After a 30-day drug washout, patients were randomly assigned to complete either ANB or FR for 5 min. After instruction, patients completed either ANB or FR, and completed the alternate task 2 weeks later.
716718|NCT02993302|May 2014 - May 2015, Patients with Graves' disease who are still in hyperthyroid condition at the outpatient clinic of Endocrinology Department of Dr. Cipto Mangunkusumo Hospital in Jakarta, Indonesia.|
716719|NCT02993250||
716720|NCT02992691|Participants were recruited at one center in Germany|A total of 100 participants were screened, out of which 25 participants were screening failure. Remaining 75 participants were enrolled in the study. Out of 75 enrolled participants, 6 did not meet eligibility criteria, 3 withdrew their consent, 10 participants, due to other reason (not specified). Remaining 56 were randomized in the study.
716721|NCT02992418|Study participants were enrolled from 19 December 2016 to 17 April 2017 at 4 centers in the Philippines. A total of 688 participants were enrolled and randomized in this study.|Safety signal was spotted in dengue non-immune participants, which led to IDMC suggestion to not vaccinate them anymore. As no Health Authority feedback was received on amendment, study was terminated before 3rd (last) injection of CYD dengue vaccine. Hence, no participants received 3rd CYD dengue dose (as planned) and all were followed for safety.
716722|NCT02992288|Study was conducted at multiple centers in 11 countries between 22 February 2017 (first participant first visit) and 16 May 2018 (last participant last visit).|Overall, 462 participants were screened. Of them, 35 participants did not complete screening due to unmet eligibility criteria, consent withdrawal, adverse events and other unspecified reasons. In total, 427 participants were randomized and 426 participants received study treatment.
716723|NCT02992236||Cross-over design, all subjects received VAS203 and placebo
716724|NCT02992197||
716725|NCT02992132|The study was planned to be conducted in approximately 432 subjects. For business reasons, and not related to safety, recruitment of subjects was stopped after 111 subjects were randomized. The last subject was randomized on 2 Nov 2017.|The screening visit was followed by a 2- to 4-week screening period, including wash-out of antipsychotic agents which were prohibited during the Treatment period (exception: protocol specified agents). Subjects had to be on stable doses of permitted medications for >=4 weeks before Baseline (>=12 weeks for cholinesterase inhibitors and memantine).
716726|NCT02992119||
716727|NCT02992067||
716728|NCT02991898||
716729|NCT02991859|A total of 56 participants were enrolled across 1 center in Germany and 2 centers in the United Kingdom.|A total of 165 participants were screened of which 109 failed screening and 56 participants were enrolled in study. Of the 56 participants enrolled,only 54 were randomized and received at least one dose of study medication. Only 7 participants were withdrawn from the study, 2 participants who were not withdrawn, entered Period 2 esc Phase 1.
716730|NCT02991820||
716731|NCT02991729||
716732|NCT02991599||
716733|NCT02991430||
716734|NCT02991118|A total of 779 participants were randomized 2:1 to receive either bempedoic acid or placebo.|The study consisted of 3 periods: a 1-week screening period; a 4-week single-blind, placebo run-in period; and a 52-week double-blind, randomized treatment period.
716735|NCT02991040|"The study was undertaken between August 24 2016 and June 21 2017. Subjects that were randomized, there were 100 intent-to-treat (ITT), 95 modified intent-to-treat (mITT), 75 per-protocol (PP) subjects. Of the subjects randomized there were 17 subjects in the rollover subset (17 ITT, 12 mITT, and 12 PP subjects).
~96 Subjects completed the study."|
716736|NCT02990910|children who scheduled for adenotonsillectomy under general anesthesia|Patients with a history of allergy, pulmonary or cardiac diseases were excluded.
716844|NCT02974140|Subjects were recruited from 3 investigative sites located in the United States.|This reporting group includes all enrolled subjects (39).
716737|NCT02990338|The study was conducted at 102 sites in 24 countries. A total of 387 participants were screened between 22 December 2016 and 01 February 2018. Out of which, 307 participants were randomized in 1:1 ratio to IPd (Isatuximab + Pomalidomide + Dexamethasone) and Pd (Pomalidomide + Dexamethasone) arms using an interactive response technology (IRT).|Randomization was stratified by age (less than [<] 75 years versus greater than and equal to [>=] 75 years) and number of previous lines of therapy (2 or 3 versus more than 3). Results are reported based on the primary completion date of 22 November 2018.
716738|NCT02990000||
716739|NCT02989805|Participant enrollment began in April 2017 and all follow-up visits were complete by December 31, 2019. Participants were enrolled from the patient population at 8 emergency departments in South Carolina.|
716740|NCT02989727|This study only analyzed data from treatment completers in the original study, NCT00274677. The original study enrolled 221 participants, with 150 completing the trial.|
716741|NCT02989714||
716742|NCT02989649|Participants took part in the study at 16 investigative sites in China from 22 Dec 2016 to 26 Jan 2018.|Participants with a diagnosis of Type 2 Diabetes Mellitus (T2DM) prescribed alogliptin or alogliptin Fixed Dose Combinations (FDCs) with either metformin or pioglitazone were enrolled in this observational study.
716743|NCT02989610|The PROGRESS study enrolled a total of 234 participants between January 2017 and January 2019 at 37 sites in Europe, the U.S. and Australia. Of which 195 participants completed 6 months follow-up visit.|Of the 234 enrolled participants, there were 230 participants who had initial study programming. Out of 212 participants who completed the 3-month visit, there were 202 with complete primary endpoint data. After the 3-month visit, 17 were withdrawn or lost to follow-up, leaving the number of participants completed as of 195 participants.
716744|NCT02989545||
716745|NCT02989389||Part A was a dose-escalation 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was a single-dose, 3-cohort (Cohorts 3, 4 and 5) study.
716746|NCT02989168||
716747|NCT02988882||
716748|NCT02988856||
716749|NCT02988843||
716750|NCT02988622|100 patients were recruited from the University of Iowa, Hospitals and Clinics between June to August 2016.|The exclusion criteria included any scar less than 6 weeks old, a history of keloid scarring, use of isotretinoin or other photosensitizing medication at the time of the study or within the previous 3 months and if the patient was pregnant.
716751|NCT02988349|"The first recruitment took place on Oct. 2013, in the Department of Operative Dentistry and Endodontics, West China Hospital of Stomatology. 15 CF and 15 CA individuals were recruited by the end of Nov. 2013.
~The second recruitment took place on May in the same location. 2014. 6 CF and 6 CA individuals were recruited by the end of Jun. 2014."|
716752|NCT02988219||
716753|NCT02988193||
716754|NCT02988115|602 participants were screened; out of 602, 345 participants were randomized. 76 participants discontinued investigational medicinal product (IMP), and 18 participants withdrew from the study.|
716755|NCT02988050||Patients were excluded if they refused to be included in the study.
716756|NCT02987972||
716757|NCT02987868|Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.|16 participants recruited; 16 Screened, 0 excluded (12 Males and 4 Females)
716758|NCT02987660|Subjects were recruited from 1 study center located in France.|Of the 21 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (20).
716759|NCT02987621||
716760|NCT02987543|Subjects were divided into two cohorts based on HRR gene mutation status. Subjects with mutations in either BRCA1, BRCA2, or ATM are in Cohort A whereas subjects with mutations among 12 other genes involved in the HRR pathway (BARD1, BRIP1, CDK12, CHEK1,CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L) are in Cohort B.|
716761|NCT02987374|During spring and early summer (prior to June 30) of 2012, 11 participants were consented to participate. One participant was found to be ineligible and was therefore withdrawn prior to any interventions.|
716762|NCT02987231|At clinical site|The study recruited 66 eligible patients. However, three patients were excluded before assignment to groups. Two recruited patients never presented for treatment and one declined to proceed.
716763|NCT02987205||
716764|NCT02986958||
716765|NCT02986854|Subjects were recruited from 1 center in Puerto Rico and 37 centers in Unites States.|704 subjects were enrolled in this study. Out of the 704 enrolled, 701 received the study vaccine
716766|NCT02986711||
716767|NCT02986373||Participants who had completed all doses of study drug and the Week 24 visit of M16-002 (NCT02719171; lead-in study) were eligible to enroll in M16-244 (this study).
716768|NCT02986282|One hundred and fifteen consecutive patients with atrial fibrillation admitted to Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw for electrical cardioversion were screened. Participants were recruited to the study from October 2012 up to December 2015.|
716769|NCT02986139|This study was conducted at 23 centers in the United States. The first participant enrolled on 29 November 2016 and the last participant enrolled on 01 September 2017.|Participants were randomized 1:1 to receive each etanercept formulation in 1 of 2 treatment sequences: AB (treatment A followed by treatment B) or BA (treatment B followed by treatment A).
716770|NCT02985996||"24 participants were recruited in Phase II, but only 18 were randomized to either Genvoya or Truvada due to lost to follow up.
~19 participants were recruited in Phase III, but only 16 were randomized to either Genvoya or Truvada due to lost to follow up."
716771|NCT02985840||
716772|NCT02985827||
716773|NCT02985684||
716774|NCT02985398||A total of 158 participants signed the ICF, of which 128 participants met the entry criteria and were randomized into the trial.
716775|NCT02984995|A total of 37 participants who met all inclusion and no exclusion criteria were enrolled in the study.|Quizartinib initial dose was 30 mg/day and escalated to 60 mg/day. For subjects receiving strong cytochrome P450 (CYP) 3A4 inhibitors, the initial dose was 20 mg/day. An increase from the initial dose of 30 mg/day to 60 mg/day or 20 mg/day to 30 mg/day was determined on Day 16 of Cycle 1 and Day 1 of Cycle 2 based on dose increase criteria.
723964|NCT02238782|21 subjects were enrolled, 12 of these subjects went on to receive treatment|
716776|NCT02984982|The study was conducted at 39 active centers in Japan. Overall 214 participants were screened between 15 November 2016 and 02 November 2017, of whom 8 were screen failure and 206 were randomized to either alirocumab arm or standard of care (SoC) arm.|Randomization was stratified by 'on statin therapy' or 'not on statin therapy' at the time of acute coronary syndrome (ACS) onset.
716777|NCT02984943||
716778|NCT02984878||
716779|NCT02984709||
716780|NCT02984644||
716781|NCT02984267||
716782|NCT02983981||
716783|NCT02983877|Thirty eight individuals with bipolar disorder (BD) and hypertension (HTN) being treated with evidence-based antihypertensive agents and mood stabilizing or antipsychotic medications who are nonadherent with their HTN medicine will be enrolled by referral. This phase uses a prospective cohort design with participants serving as their own control.|After providing informed consent, all participants will undergo screening followed by a 30-day run-in period in which adherence will be measured using eCAP and self-report. During the 30-day run-in period, participants will continue to receive care as usual and serve as their own control with no intervention.
716784|NCT02983825||
716785|NCT02983617|Participants were enrolled at study sites in Germany. The first participant was screened on 6 April 2017. The last Week 25 study visit for the primary endpoint occurred on 20 February 2019.|38 participants were screened. Randomization was discontinued after implementation of Protocol Amendment 3; all additional participants were enrolled to Arm: Tirabrutinib + Entospletinib + Obinutuzumab.
716786|NCT02983604|Participants were enrolled at study sites in the United States. The first participant was screened on 10 January 2017. The last study visit occurred on 19 July 2018.|17 participants were screened.
716787|NCT02983448||
716788|NCT02983305||
716789|NCT02983227|The study was conducted at 138 centers in 19 countries.|496 participants were enrolled into this OLE study and were included in the ITT and Safety populations.
716790|NCT02983058|Study subjects were exclusively recruited from the Amish and Mennonite community in Lancaster, Pennsylvania (PA). All subjects with psychotic spectrum disorder were receiving clinical care at the Clinic for Special Children in Strasburg, PA and identified an unaffected 1st or 2nd degree relative (unaffected subject).|All subjects (affected and unaffected) who met inclusion/exclusion criteria were included in the study.
716791|NCT02982928||
716792|NCT02982863|A retrospective, observational study using health insurance claims data.48696 patients were prescribed dabigatran, warfarin, apixaban, edoxaban, or rivaroxaban as the first OACs but 50 patients were removed as they took more than one these drugs. Thus only 48646 patients were prescribed the drugs of interest.|"The Japanese patients diagnosed as Non-Valvular Atrial Fibrillation (NVAF) between April 2010 and June 2016, were prescribed dabigatran, warfarin, apixaban, edoxaban, or rivaroxaban as the first OACs.
~DPC; Diagnosis Procedure Combination (DPC)"
716793|NCT02982720||
716794|NCT02982239|Student-athletes were recruited over the summer and through the first 2 weeks of the 2015 Fall semester, as they arrived on campus. Recruitment was accomplished through flyers, referrals from athletics staff, and in-person recruitment among athletes at on campus athletic facilities.|All students who completed the survey were eligible for the intervention study, though selection was targeted to those with sleep complaints.
716795|NCT02982187|This is a randomized, multi-center, open-label, cross-over study comparing Placebo ELLIPTA Dry Power Inhaler (DPI) with either Placebo DISKUS DPI + Placebo Handihaler or Placebo Turbuhaler plus Placebo Handihaler to assess correct inhaler use. A total of 5 centers, 3 in the Netherlands and 2 in the United Kingdom participated in the study.|A total of 160 participants were screened. Eighty were assigned to sub-study 1 and 80 to sub-study 2 according to naivety to inhalers in each sub-study. One participant in sub-study 2 withdrew consent prior to device assessment. Therefore 80 par in sub-study 1 and 79 par in sub-study 2 are included in the intent to treat population.
716796|NCT02982018|A total of 133 subjects were enrolled into the study. Of the enrolled subjects 131 were dispensed study lenses and 2 subjects failed to meet the eligibility criteria. Of the dispensed subjects 123 completed the study and 8 subjects were discontinued.|
716797|NCT02981602|This study evaluated safety, tolerability, pharmacokinetics and antiviral activity of GSK3228836 in two population of participants with Chronic Hepatitis B (CHB) virus infection: treatment-naive participants (Cohorts 1, 2 and 3) and participants on stable nucleos(t)ide treatment (Cohort 4)|A total of 31 participants were enrolled and received either GSK3228836 or placebo. In Cohort 3 participants were administered GSK3228836 300 milligram [mg] instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
716798|NCT02981524||
716799|NCT02981342|"Study was planned for stage 1 & stage 2. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
~Completed participants are those who has CR, PR, SD, or PD and is off treatment."|Per protocol, no efficacy analysis was planned for safety lead in. Purpose of safety lead in was only safety evaluation. All efficacy was done on randomized pts.
716800|NCT02980978||
716801|NCT02980783||
716802|NCT02980601||
716803|NCT02980523||
716804|NCT02980224||
716805|NCT02980211||
716806|NCT02980133||A total of 841 participants with persistent asthma were randomized in a 1:1:1:1 ratio to receive Fp MDPI 25 mcg, Fp MDPI 50 mcg, FS MDPI 50/12.5 mcg, or placebo MDPI. Randomization was stratified by previous therapy (inhaled corticosteroid [ICS] or non-corticosteroid [NCS]).
716807|NCT02980107||
716808|NCT02980042||
716809|NCT02979899||
716810|NCT02979639||A total of 404 subjects were enrolled in the study. However,1 subject was considered not eligible per the exclusion criteria (had previously received a Zoster vaccine) & 2 subjects were not vaccinated due to voluntary consent withdrawal.Hence,401 subjects were considered to have started the study & administered the first study vaccine (Exposed Set)
716811|NCT02979613|Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 29 December 2016. The last study visit occurred on 30 January 2020.|541 participants were screened.
716812|NCT02979535|Study participants were enrolled from 16 November 2016 to 13 March 2017 at 3 centers in Mexico.|A total of 480 participants were enrolled and randomized in this study.
729994|NCT01795716||
729995|NCT01795638||
716814|NCT02979431||A total of 301 subjects were screened.180 subjects were randomized to receive ALX-0171 3.0 mg/kg, ALX-0171 6.0 mg/kg, ALX-0171 9.0 mg/kg or placebo, yielding an overall allocation ratio of 3:1 active to placebo.
716815|NCT02979301||
716816|NCT02979262|Fathers were recruited from two 6-month men's residential substance use treatment facilities. Both programs followed a 12-step facilitation therapeutic milieu approach. Information about the study was provided by facility staff to men who entered the facility, completed 30 days of treatment and had a biological child under the age of 16.|Screening: 1) had some contact with his children via phone, letters or in person visits; 2) reported either physical or psychological aggression toward his female co-parent in the last 12 months; and 3) could complete study interviews and intervention in English. Eligible men met individually with an RA to complete baseline measures.
716817|NCT02979249||
716818|NCT02979197||Eligibility assessments were made at Initial Screening (Day -14 to -10), Final Screening (Day -1), and prior to randomization (Day 0). Subjects who met eligibility criteria at Initial Screening underwent a 10- to 14-day washout from their blood pressure medication and those who continued to meet criteria at the end of the washout were randomized.
716819|NCT02979054||157 screened patients disposed as: 135 patients treated and randomised, 20 patients not included (reasons: screen failures: 14, protocol violation: 1, consent withdrawal: 4 and other reasons: 1) and 2 patients treated but not randomised.
716820|NCT02978833||
716821|NCT02978508||
716822|NCT02978417|Community treatment provider Fellowship Health Resources (FHR) prescreened 19 people as eligible. Two declined to participate and 3 were terminated from court and lost eligibility, leaving 14 potential subjects.|Fourteen subjects consented to be in the study and completed a baseline interview. Four were terminated from court thereby losing eligibility, so they were not randomized.
716823|NCT02978339||
716824|NCT02978157|"recruitment period: February 2015
~Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital"|None were excluded following participant enrollment.
716825|NCT02977572||
716826|NCT02977507||
716827|NCT02976519|The trial was conducted in 2 parts. The first part was a multiple rising dose (MRD) trial in healthy participants. The second part followed a cross-over design with respect to placebo and BI 443651 treatment in participants with cystic fibrosis. Both parts were randomised, placebo-controlled, and double-blinded.|All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that they (all participants) met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
716828|NCT02976181||
716829|NCT02976103|Recruitment dates: 03/09/2017-12/21/2017|
716830|NCT02975973|The reason we have fewer subjects randomized than enrolled is that some participants did not meet criteria to be randomized. These subjects were consented and completed many assessments, but were ultimately not randomized due to how they scored on some assessments. For instance, some peoples MCCB score was too high to be randomized into the study.|The primary reasons for ineligibility were not meeting the early psychosis criterion (< 5 years of treatment), not taking any medication, and drug use. There were also many who did not even enter screening due to the assessment that they would highly likely not meet the threshold of requirement cognitive impairment (MATRICS score 40).
716831|NCT02975804||
716832|NCT02975700|A total of 8 participants entered the pilot portion of the study; no participants entered the phase 2 portion. Of the 8 participants, 2 failed screening criteria and did not receive treatment.|
716833|NCT02975557|Subjects were recruited from the clinical practice of the investigator at the time of their routine eye examination visit. The clinical practice is located in the Illinois Eye and Ear Infirmary (EEI), the University of Illinois at Chicago (UIC). The first participant was enrolled in May 2016, and the last participant was enrolled in February 2017.|
716834|NCT02975336|A total of 1053 participants with Systemic Lupus Erythematosus (SLE) were screened. Out of which, 469 participants were randomized in ratio of 1:1:1:1 to 1 of the 4 treatment groups: Placebo; M2951 25 milligrams (mg) once daily (QD), M2951 75 mg QD and M2951 50 mg twice daily (BID).|
716835|NCT02975206||
716836|NCT02974868|The study had a 24 week Treatment Period, a 4 week Drug Holiday, an up to 48 weeks(24 weeks + additional 24 Weeks for those received active retreatment) Single Blind Extension Period, a 4 week Drug Holiday, a 24 weeks Cross Over Open Label Extension Period.|"Criteria for entering SBE: complete the former period without showing Key Exclusion defined in CSR Section 9.3.2.
~Criteria for entering COE: non-responders (SALT change from baseline <30%) at Week 24 and continued to be non-responders at Week 52 in SBE period without showing Key Exclusion defined in CSR Section 9.3.2."
716837|NCT02974855||A total of 27 participants were enrolled in the study and assigned to 1 of 4 cohorts. Only 26 participants received the study treatment and 1 participant withdrew after randomization but prior to dosing.
716838|NCT02974842|Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation were recruited from three gynecologic oncology centers in the United States.|This was a single arm study evaluating the feasibility of a novel hysteroscopic catheter to collect cytological samples.
716839|NCT02974686||Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
716840|NCT02974634|"Participants were enrolled at three study sites through several mechanisms. These include identification of potential participants via institutional registry, records,databases.Referrals from site WOCNs, attending surgeons and other clinical providers; and through distribution of Institutional .
~Subjects were recruited from 11/01/16 to 10/01/2018."|All cancer survivors over 21 years of age who were at least six weeks after a surgical procedure that necessitated the creation of an intestinal stoma (fecal or urinary) were recruited. Survivors with temporary ostomies were included, and there was no maximum time since surgery.
716841|NCT02974543||14 participants consented to the study, but were screened out of allocation to either arm for excess hearing loss, lack of somatosensory modulation, or unwillingness to participate (largely due to time committments/availability).
716842|NCT02974296||
716843|NCT02974153||A total of 2263 participants signed the ICF, of which 1121 participants met the entry criteria and were randomized into the trial.
729996|NCT01795547||
729997|NCT01795534||
716845|NCT02974114|All participants were recruited at a single center from the United Kingdom.|A Total of 54 participants were screened, out of which 21 participants were randomized to the study, 5 participants were screening failure, 1 participant withdrew consent and 27 participants were not randomized due to other reasons (not specified).
716846|NCT02974088|Recruitment between 26 May 2006 and 31 August 2006. Community recruitment with domiciliary visits|
716847|NCT02973802|This study enrolled patients diagnosed with Graves Disease from 8 hospital clinics located in the UK. The last patient enrolled completed dosing in February 2018.|28 subjects were screened for the study, of which 12 were eligible, and commenced treatment with ATX-GD-59.
716848|NCT02973503||
716849|NCT02973477||
716850|NCT02973438||
716851|NCT02973100|The study consisted of 3 periods: an approximately 2-week lead-in period, followed by an 18-week treatment period, and a 4-week safety follow-up period.|
716852|NCT02973048|All participants were recruited at CHU Saint-Pierre and Sainte-Anne Saint-Rémy hospitals (Brussels). Of 88 patients assessed for eligibility, only 40 were randomized to treatment (17 not meeting inclusion criteria and 31 declined to participate)|
716853|NCT02972658|Participants who completed feeder study [AZES (NCT02245737)] were enrolled in this study.|Participants who were randomized in Study AZES to either 20 milligrams (mg) or 50 mg of lanabecestat continued on the treatment allocation from the feeder study. Participants randomized to placebo in Study AZES were randomized in a blinded fashion, 1:1 ratio, to either lanabecestat 20 mg or 50 mg daily (QD), administered orally.
716854|NCT02972632|Participants took part in the study at 23 investigative sites in United States from 22 December 2016 to 06 February 2018.|Participants with a diagnosis of major depressive disorder were enrolled to receive vortioxetine with a starting dose of 10 mg for 12 weeks. Dose was increased or decreased as per investigator's discretion.
716855|NCT02972554|Healthy young adult participants were recruited from campus via flyers and listserv postings. All participants were screened over telephone to ensure they were healthy.|No enrolled participants were excluded from the study before assignment to groups.
716856|NCT02972515||
716857|NCT02972502||
716858|NCT02972359|The first participant was enrolled on 20 December 2016.|A total of 580 participants signed an informed consent form, 318 participants hereof were allocated to treatment. Two of the allocated participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants received treatment.
716859|NCT02972242||
716860|NCT02971839||
716861|NCT02971670||
716862|NCT02971631|Five participants recruited from Hereditary Diffuse Gastric Cancer patient population|
716863|NCT02971605||
716864|NCT02971488||
716865|NCT02971293|This study was conducted at two centres, one each in Germany and the UK. The first patient was enrolled in December 2016 and the last patient last visit was in August 2017.|A total of 103 patients were screened; 42 patients were eligible to participate and were randomised.
716866|NCT02971202||
716867|NCT02971163|After screening 351 patients, 51 randomized, one was excluded because not syncope, resulting in 50 participants enrolled with unexplained syncope from January 2017 to January 2019.|
716868|NCT02971007|Recruitment period November 2016 to May 2017 at 22 medical clinics in USA|Enrolled patients were excluded from the study before assignment to groups due to abnormal laboratory test results, negative potassium hydroxide test (KOH) for vaginal yeast or vaginal pH greater than 4.5 during the screening process.
716869|NCT02970981||
716870|NCT02970812||
716871|NCT02970669|140 subjects from 23 sites in the US were randomized. The study consisted of a 2-week baseline period , followed by an 8-week double-blind treatment period ( randomized to sacubitril/valsartan or enalapril, in a 1:1 ratio), followed by an 8-week open label extension period during which all patients were treated with sacubitril/valsartan.|
716872|NCT02970552||
716873|NCT02970422|200 participants completed the AHRPQ. Of those, 52 were missing spirometry in medical records, 148 completed with spirometry for Quartile 1-4 analysis [groups], and 130 of the 148 completed spirometry, exacerbation and mMRC for Group A-D analysis.|
716874|NCT02970305||
716875|NCT02970292||
716876|NCT02970162||
716877|NCT02970032||All 20 patients that were enrolled in the standard heparin dose arm crossed over into the real time heparin dose adjustment arm per the pilot protocol with undetectable anti-Xa levels (<0.10).
716878|NCT02969928||
716879|NCT02969876||
716880|NCT02969863||27 subjects were enrolled, but only 24 participated in the study. 2 subjects were ineligible, and 1 could not participate for scheduling reasons. 1 of the 24 was terminated by the investigator during the first arm of the study, so that 1 subject only started 1 arm. 23 subjects finished that arm, and 23 subjects started and finished the other arms
716881|NCT02969655|A total of 50 centers, contracted in Japan, enrolled and randomized participants. A total of 271 participants were enrolled and randomized in this study.|A total of 332 participants were screened of which 61 failed screening reasons being participants did not meet inclusion/exclusion criteria (48), physician decision (3) and withdrawn by participant (10), hence 271 participants were enrolled and randomized.
716882|NCT02969590||In order to qualify for the intervention phase, subjects needed to demonstrate an ovulatory menstrual cycle during the Screening Period.
716883|NCT02969525|The study started to enroll patients in October 2016 and concluded in July 2018.|"The study included a 28-Day Screening Period, followed by a Double-blind Period from Day 1 to Week 12, prior to treatment re-randomization, a Dose-blind Period, from Week 12 after the treatment re-randomization and up to Week 48 and a Safety Follow-Up (SFU) Period, post week 48.
~The Participant Flow refers to the Randomized Set and Dose-Blind Set."
716884|NCT02969421||
716885|NCT02969408||A total of 449 participants with exacerbation-prone asthma were screened, of which 397 participants at 45 investigational centers in the US met entry criteria and were considered to be eligible for enrollment into the study.
716965|NCT02960854||38 subjects were enrolled in the study. 31 were randomized; 7 not randomized: (5) Failed to meet study eligibility criteria, (1) died, (1) withdrew consent
716966|NCT02960295||
719143|NCT02675075|Subjects were recruited from the amyotrophic lateral sclerosis (ALS) Clinic at the James A. Haley Hospital from January 2016 to November 2017|
716886|NCT02969356|This multicenter, single-arm study was conducted in 18 centers in 4 countries between 22 December 2016 and 18 July 2018 in participants with spastic hemiparesis due to acquired brain injury. Study had 2 treatment cycles separated by at least 12 (maximum 20) weeks and combined with Guided Self-Rehabilitation Contract (GSC) for whole study duration.|A total of 157 participants were treated in this study. At baseline (Cycle 1, Day 1), the primary treatment target (TT) limb (upper limb [UL] or lower limb [LL]) was defined by the investigator, following discussion with the participant. If the primary TT limb was the UL, the secondary TT limb was the LL (and vice versa).
716887|NCT02969317|12 patients were entered to receive treatment with tiotropium+olodaterol fixed-dose combination (FDC) 5 microgram / 5 microgram (5 μg / 5 μg). All of the 12 entered patients were treated with trial medication.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
716888|NCT02969187||
716889|NCT02969044||
716890|NCT02969031||
716891|NCT02969018||
716892|NCT02968992||
716893|NCT02968979|56 oncologists, lung specialists or radiation oncologists treating patients with a malignant lung tumour have recruited patients from outpatient visit, day hospital or in-patient hospitalization in France and Belgium, between the 25th of July and the 31th of October 2016. Patients were recruited in a consecutive manner.|"539 patients were recruited. Among them, 5 did not meet the eligibility criteria, 1 withdrew his/her consent, 2 were excluded during the data review because the cancer histology was undefined.
~The analysis population included 531 patients and among them 312 had skeletal muscle mass assessment."
716894|NCT02968914|Subjects who met all the inclusion and none of the exclusion criteria were enrolled at PAREXEL Early Phase Clinical Unit in Berlin and London.|Subjects attended a Screening Visit within 28 days before receiving their first dose of Benralizumab. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study-related procedures.
716895|NCT02968758||
716896|NCT02968576|IRB approval was obtained for 48 subjects to allow for screen failures, withdrawals, lost to follow up, etc.|
716897|NCT02968563|Participants were enrolled at study sites in Germany. The first participant was screened on 13 December 2016. The last Week 25 study visit for the primary endpoint occurred on 17 June 2019.|35 participants were screened. Randomization was discontinued after implementation of Protocol Amendment 3; all additional participants were enrolled to Arm: Tirabrutinib + Idelalisib + Obinutuzumab.
716898|NCT02968433||
716899|NCT02968368||
716900|NCT02968277||
716901|NCT02968173||
716902|NCT02968134||
716903|NCT02967991||
716904|NCT02967679||
716905|NCT02967562||
716906|NCT02967510||
716907|NCT02967458||
716908|NCT02967393||"Feasibility Measures are done by the parent/guardian of the participants. Feasibility Measure data will be reported as a single group.
~Participant data (vaccine data) will be reported by the type of vaccination received."
716909|NCT02967367||
716910|NCT02967354||
716911|NCT02967055||
716912|NCT02967016||
716913|NCT02966795|This study was conducted in 24 hospitals or clinics in Europe (Belgium, France), Oceania (Australia, New Zealand), North America (Canada, USA), South Africa, and southeast Asia (Singapore, Vietnam). Participants were screened between January 17, 2017, and December 26, 2017.|Enrolled participants with genotype 5 or 6 hepatitis C (HCV) were assigned to treatment with glecaprevir/pibrentasir for either 8 weeks or 12 weeks based on cirrhotic status.
716914|NCT02966509|August 2013 recruitment for overall study through new patient visit screening, phone calls to patients prior to first oncology appointment, and referral by physicians when diagnosed with recurrent cancers. Recruitment completed in February 2015.|
716915|NCT02966353||Screening evaluations were performed to determine the eligibility for the study and establish a baseline prior to dosing.
716916|NCT02966340||In order to enroll 64 participants with valid data, 70 participants were randomized to account for 4 lost early in study flow (one data collection error, two startle non-responders, and one withdrawn after visit 1).
716917|NCT02966275||10 participants were enrolled in the trial and participated in the study
716918|NCT02966223||
716919|NCT02966015||
716920|NCT02966002||
716921|NCT02965924||
716922|NCT02965846||Of the 43 participants who enrolled in the study, 10 were randomized and received intervention to compromise the safety and Intent to Treat (ITT) populations
716923|NCT02965833|Subjects were recruited from 9 study centers located in the United States.|Of the 126 enrolled, 5 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (121).
716924|NCT02965820|Subjects were recruited from 8 study centers located in the United States.|Of the 122 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (121).
716925|NCT02965729||
716926|NCT02965599|This study was conducted in participants with severe, active rheumatoid arthritis receiving GSK3117391, 40 milligrams (mg) or placebo at one center in Poland and one in Romania.|This study was terminated early by the sponsor following internal review. A total number of 26 participants were screened, of which three participants were enrolled in the study.
716927|NCT02965534||
716928|NCT02965456||Participants were randomized in a 1:1 ratio to receive either IDP-121(tretinoin 0.05 percent [%]) Lotion or IDP-121 Vehicle Lotion.
716929|NCT02965144|A database comprised 18 patients, who were screened; 1 declined participation due to lack of motivation and 4 were lost to follow-up during screening. A total of 13 pt were enrolled, started the study and completed the study.|
716930|NCT02964910||
716931|NCT02964767|Patients with HIV infection enrolled at ART centre, Khagaria, India, during June'2015 to May'2016 were recruited.|patients, who were Lost to Follow Up (LFU), were excluded from study.
717224|NCT02925923||
717225|NCT02925858||
717226|NCT02925741||Eleven patients refused the synthetic linens.
716932|NCT02964416|"Over a period of two years, 2016 and 2017
~Patients were recruited in the study during the preoperative anesthesia evaluation either at the preoperative clinic or from the ward after admission."|A total of 80 patients were enrolled and selected to randomize. 39 patients in Tramadol group and 41 patients in placebo group.79 patients completed the study as one patient in tramadol group dropped out due to change/ modification in his surgical procedure.
716933|NCT02964338|Participants with a history of chronic cluster headache (CCH) were enrolled. Eligible participants entered baseline cluster headache (CH) attack information into an electronic diary device daily for greater than or equal to (≥)4 weeks during the Baseline Period.|A total of 259 participants were randomly assigned with stratification based on sex, country, and baseline concomitant preventive medication use (yes/no) to either placebo, fremanezumab 675/225/225 milligrams (mg), or fremanezumab 900/225/225 mg treatment groups in a 1:1:1 ratio.
716934|NCT02964312||
716935|NCT02964247|The trial was conducted at 74 sites in 7 countries. All the sites have screened and randomised subjects. Brazil: 3 sites, India: 7 sites, Israel: 6 sites, Mexico: 2 sites, Russian Federation: 3 sites, United Arab Emirates: 5 sites, United States: 48 sites screened and randomised subjects.|
716936|NCT02964234||
716937|NCT02964078||
716938|NCT02963987|Participants for the study were recruited from 7 classrooms of 2 childcare centers in University Park, PA from June 2015 to April 2016.|
716939|NCT02963935|The trial was conducted at 17 sites in the United States.|All the subjects received Intensive Behaviour Therapy (IBT) for obesity in a primary care setting according to Centers for Medicare & Medicaid Services (CMS) visit schedule during the trial.
716940|NCT02963922|The trial was conducted at 53 sites in Canada (7), Germany (7), Israel (6), Italy (4), Mexico (2), Turkey (7) and United States (20).|Participants were randomised in a 1:1 manner to receive either liraglutide or placebo as an adjunct to a reduced-calorie diet and increased physical activity as part of a comprehensive lifestyle intervention program.
716941|NCT02963701||This study was an Open-label, randomised, laboratory blind, single dose, two-way crossover, Phase I trial. A total of 56 healthy male and female subjects were randomised in the trial. Subjects were assigned randomly to one of two treatment sequences (Test-Reference, Reference-Test), before first drug administration.
716942|NCT02963597|Subjects were recruited from the inpatient clinical services of the Albert Einstein Medical Center Philadelphia (US) and from the Heart and Diabetes Center of North Rhine-Westphalia (Germany). Patients signed an informed consent for the study prior to any study-related procedure. Before randomization, all eligibility criteria were confirmed.|
716943|NCT02963506|The study started to enroll participants in October 2016 and concluded in August 2018.|"The study included a 28-Day Screening Period, followed by a Double-Blind Period from Day 1 to Week 12, prior to treatment re-randomization, a Dose-blind Period, from Week 12 after the treatment re-randomization and up to Week 48 and a Safety Follow-Up (SFU) Period, post Week 48.
~The Participant Flow refers to the Randomized Set and Dose-Blind Set."
716944|NCT02963311||
716945|NCT02962960|Participants type I Interferon (IFN) test-high Systemic Lupus Erythematosus (SLE) subjects with active skin manifestations while receiving Standard of Care (SOC) treatment were eligible for the study.|36 patients were randomized, and all received at least one dose of study treatment.
716946|NCT02962934||
716947|NCT02962908||"195 subjects were screened. Of those, N=20 subjects were removed from the study prior randomisation due to:
~lost to follow up n=3
~didn't wish to continue after screening visit n=9
~did not meet inclusion/exclusion criteria n=8"
716948|NCT02962882|"Investigation period: Sept 2016 - Nov 2016. This study was conducted in two sites in the US, on patients being treated in an ICU who were at risk of developing pressure injuries.
~The target subjects were male or female, aged 18 years or above, with an expected stay of 4-6 days in an ICU."|
716949|NCT02962687||
716950|NCT02962648|A total of 193 subjects were screened and 103 subjects were enrolled into the trial.|Subjects enrolled in this extension trial had previously participated in the lead-in trials IDA-03 (52%, NCT02940886), CKD-04 (32%, NCT02940860), and IDA-01 (16%, NCT02130063).
716951|NCT02962609||
716952|NCT02962427||
716953|NCT02962284|A total of 20 subjects were enrolled in the study. Of these, 9 subjects were previously treated with YONSA and 11 subjects were previously treated with Zytiga in CHL-AA-201. Twelve (60.0%) subjects completed the study|
716954|NCT02961946||
716955|NCT02961920|Between November 2016 and October 2018, 50 patients who underwent lumbar spine surgery in our institution were assessed. Two patients dropped out. Thus, 48 patients achieved study protocol.|
716956|NCT02961894||
716957|NCT02961790||
716958|NCT02961764||
716959|NCT02961751|Sites/clinics recruited subjects from their existing patient population, patients that were sent by referral from other clinics, and walk-ins. 232 volunteers were screened to enroll 211 subjects between 13SEP2016 and 31DEC2018.|
716960|NCT02961244|Between June 2013 and December 2015 elective, preoperatively not infected/dirty, open major abdominal operations under general anesthesia, longer than 30 minutes and over 18 aged were included in the study. Primary outcome was comparison of SSI rates between groups and secondary was effects of protocol to normothermia.|Exclusion criteria were emergent surgery, local/locoregional procedures, laparoscopic operations, minor abdominal operations, malign hyperthermia, signs of active infection/fever, immunosuppression, malnutrition, kidney/liver failure, antibiotic use within the previous 1 week/ımmunsupresive use within previous 1 month, reversal of approval.
716961|NCT02961218|A total of 49 participants were randomized into the study from 15 centers in seven countries: Greater Britain (5), Israel (1), Germany (1), Turkey (3), South Africa (1), USA (3) and Canada (1).|Subjects who met the eligibility criteria at screening underwent evaluation of baseline clinical and biomarker assessments prior to first dose administration.
716962|NCT02961062|A total of 40 patients were randomized in a 1:1 ratio to two treatment sequences: SAF312 followed by Vehicle, or Vehicle followed by SAF312.|Bilateral crossover design: A crossover design was utilized in order to decrease the inter-patient variability due to different pain tolerance in different individuals.
716963|NCT02960997||
716964|NCT02960893|181 participants were screened, and 141 of these participants were randomized to treatment at 18 sites in the United States.|
717267|NCT02920450|Recruitment period was from 9/25/2017 until 12/06/2018, at which point the study was closed due to low accrual.|
716967|NCT02960217||"During a 6-week Run-in Period, participants recorded disabling paroxysmal movement disorder events in a daily electronic Glut1 DS movement disorder diary.
~One participant was randomized but did not receive any treatment due to a protocol violation; this participant was not included in any analysis population."
716968|NCT02959996||40 patients enrolled in both groups, however 1 patient in the liposomal bupivacaine group was excluded after randomization.
716969|NCT02959983||A total of 660 participants were screened; 346 participants were randomized; 344 participants received at least 1 dose of study drug which comprises the safety population. Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study.
716970|NCT02959970|The study was conducted at 20 sites in United States (US) between 31 October 2016 (first participant first visit) and 09 March 2018 (last participant last visit).|A total of 105 participants were screened, out of which 100 participants were enrolled into either of the 2 cohorts, Pharmacokinetic (PK) Cohort and Non-PK Cohort.
716971|NCT02959892|Participants took part in the study at 1 investigative site in United Kingdom from 05 December 2016 to 23 August 2017.|Healthy participants were enrolled in this study to receive TAK-041 in one of the 2 treatment groups: TAK-041 20 milligram (mg) or TAK-041 40 mg.
716972|NCT02959866||Clinicians will be encouraged to screen patients for poverty and use the online tool with every eligible patient during 3-months. It is difficult to estimate how many patients will be seen during the 3-month time period, the number who will be living in poverty, the number who agree to the intervention and be consented to the study for follow-up.
716973|NCT02959853||
716974|NCT02959840||
716975|NCT02959827|This study was a retrospective cohort study, using the data from the years 2008 to June of 2016 in the database of Kaiser Permanente Northern California.|There were 2320 children identified in Kaiser Permanente Northern California who met our study population criteria: patients who had a procedure that used iodinated contrast agent and were under the age of 4, during the years 2008 to June of 2016.
716976|NCT02959814||
716977|NCT02959437|The study was conducted at 8 sites in United States, 2 sites in UK and 1 site in Spain.|A total of 70 participants were enrolled in the study. Study enrollment was permanently discontinued on 15-Feb-2019 as a strategic decision. At the time of data cut-off, 2 participants were ongoing treatment. No patients were enrolled in Treatment Group B and Treatment Group C.
716978|NCT02959307||
716979|NCT02959190|Episodic migraine (EM) participants rolled over from parental Study I5Q-JE-CGAN (CGAN - NCT02959177)), and chronic migraine (CM) participants were newly enrolled in this CGAP study.|
716980|NCT02959177||Participants were randomized to a Treatment Phase with double-blind treatment arms and then could enter a Follow-up Post Treatment Phase.
716981|NCT02959138|Participants were enrolled at study sites in United States, New Zealand, and Germany. The first participant was screened on 21 November 2016. The last study visit occurred on 05 October 2018.|75 participants were screened. Participants in adaptive Cohort 3 (Mild renal impairment) were not enrolled following review of safety and pharmacokinetic (PK) data from participants in Cohort 1 (moderate renal impairment).
716982|NCT02958995|Participants took part in the study at 2 investigative sites in the United States from 01 July 1997 to 30 June 2011.|Participants with a historical diagnosis of Type 2 diabetes mellitus (T2DM) with pioglitazone exposure identified from the Kaiser Permanente of Northern California(KPNC) Diabetes Registry (with or without diabetes) and had completed Member Health Survey (MHS) were enrolled in the epidemiology study.
716983|NCT02958982|Participants were recruited between 03 Nov 2016 to 05 Apr 2017 for Single Ascending Dose (SAD) study and patients were recruited between 12 May 2017 to 26 Aug 2017 for Multiple Ascending Dose (MAD) study|There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo (SAD and MAD). The proof of concept study was terminated prematurely after enrolling only one patient. Therefore, no analysis was performed.
716984|NCT02958969||
716985|NCT02958956|Participants took part in the study at 2 investigative sites in the United States from 01 July 1997 to 30 June 2012.|Participants with a historical diagnosis of T2DM with pioglitazone exposure identified from the Kaiser Permanente of Northern California(KPNC) Diabetes Registry were enrolled in this observational study.
716986|NCT02958826||
716987|NCT02958787||
716988|NCT02958553|The EmPOWERing Active Seniors with Energy Study first subject was enrolled February 10, 2017. The last subject was enrolled November 6, 2017. All subjects were enrolled at a single study site which was a lower-limb rehabilitation clinic.|
716989|NCT02958345||
716990|NCT02958267|Number of participants to be treated was capped at 30 participants. However, the approved protocol allowed enrollment of up to 45 participants to achieve a treatment group of 30 participants.|Based on the recruitment details stated, if a participant enrolled but subsequently withdrew or was withdrawn prior to treatment, another participant was enrolled in order to achieve a number of 30 participants who were treated within the study. Per protocol, consented patients could include up to 45 if needed to achieve 30 treated participants.
716991|NCT02957942||
716992|NCT02957747||
716993|NCT02957331||
716994|NCT02957305|Participants with diagnosis of miscarriage and scheduled for Manual Vacuum Aspiration at the Gynecologic Emergency Unit of Hospital de Clínicas de Porto Alegre, a tertiary teaching hospital, were recruited. The first participant was enrolled on December 21, 2016.|A total of 269 were screened. From these, 211 were enrolled and randomized to treatment. After randomization, 2 cases, one case of infected abortion and one case with previous cervical conization were identified and they were treated as for intention to treat.
716995|NCT02956967||
716996|NCT02956837||Out of 406 subjects initially enrolled in the study, 6 subjects had numbers allocated but did not receive any study vaccine dose, hence only 400 subjects were included in the Total Vaccinated Cohort.
716997|NCT02956746||
716998|NCT02956629|Males and females of at least 18 years of age, with chronic Hepatitis C Virus (HCV) infection were enrolled in this study.|
716999|NCT02956616||
717000|NCT02956460||
717001|NCT02956278||As the intent of the protocol was to characterize the effect of the genetic variant, data were collected and analyzed per genotype variant regardless of number of doses received.
717002|NCT02956122|Study was conducted between 26 April 2017 (first participant first visit) and 03 May 2018 (last participant last visit).|A total of 1 participant was enrolled and completed Part 1 (GLASSIA) of the study, and was analyzed for efficacy and safety with individual PK parameters estimated. Part 2 (GLASSIA versus albumin [control]) was not initiated following discontinuation of the study due to operational and business considerations.
717003|NCT02956070||
717004|NCT02956057||
717005|NCT02956005||
717006|NCT02955797|Study participants were enrolled in 34 centers in Spain, Hungary, Germany and Finland from 24 February 2017 to 21 September 2017.|A total of 918 participants were enrolled and randomized in the study.
717007|NCT02955212|"Participants were enrolled at 37 sites in Brazil, China, and South Korea.
~The study consists of a 12-week placebo-controlled, double-blind period (Period 1), and an ongoing open-label 52-week extension period (Period 2). Results for Period 1 are reported."|Participants who met eligibility criteria were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by country and the Chinese population was expected to comprise up to 80% of the total study population.
717008|NCT02955186||54 participants agreed to the study but 4 did not end up participating in the full study and were never randomized to treatment.
717009|NCT02955147|Between December 2016 and August 2018, we screened 16 GCA patients for this trial. Three patients failed the screening process and 13 patients were enrolled.|Three patients failed the screening due to dementia (N = 1), severe prednisone-induced depression (N = 1), and positive hepatitis B core antibody (N = 1)
717010|NCT02954952||
717011|NCT02954887||
717012|NCT02954848|Participants took part in the study at 44 investigative sites in Japan from 15 November 2016 to 26 February 2018.|Participants with a diagnosis of non-erosive gastroesophageal reflux disease (NERD) were enrolled and received one tablet of placebo orally, once daily in a run-in period. After that, the participants who met all the entry criteria were randomized in 1:1 ratio to receive TAK-438 10 mg or TAK-438 placebo-matching tablets.
717013|NCT02954653||Due to early termination of the study, the planned higher PF-06747143 dose levels (3, 10, 15, and 20 milligrams per kilogram [mg/kg]) in Part 1 were not tested; Part 2 was not conducted.
717014|NCT02954601|Following the screening, eligible subjects entered a 3-day, single-blind placebo run-in. On Day 4, each subject was randomized to a treatment sequence for each of three treatment periods, each period was either placebo or 1 of the 3 treatments). All subjects received placebo and only 2 of the 3 treatments.|The number of participants receiving each intervention, in each Period, is reported. In each treatment period, each subject received randomly either placebo, qd, bid, or tid for each of 3 treatment periods. Subjects received the randomized treatment from Day 4 through Day 8. There was a 24-hour single-blind placebo washout on Day 9.
717015|NCT02954575||
717016|NCT02954354|This study was conducted at 297 sites, consisting of 141 sites in Japan, 149 sites in the United States, and 7 sites in Canada. Participants were enrolled from December 2016 to April 2017.|"Participants 20 to 64 years of age were randomly assigned in a 2:2:1 ratio to receive a single oral dose of baloxavir, 75 mg oseltamivir twice daily for 5 days, or matching placebos.
~Participants 12 to 19 years of age were randomly assigned in a 2:1 ratio to receive a single dose of either baloxavir or placebo."
717017|NCT02954198||
717018|NCT02954172||
717019|NCT02954159||
717020|NCT02953938|73 patients were screened and 59 were randomized on a 1:1 ratio to the ranibizumab group (29 patients) and ranibizumab with laser group (30 patients). Of the randomized patients, 56 (94.9%) completed the study and 11 months of treatment. 3 (5.1%) discontinued both study and study treatment: 2 (3.4%) withdrew consent and 1 (1.7%) had adverse event|Below is the participant flow of Randomized patients
717021|NCT02953886||
717022|NCT02953873||
717023|NCT02953821||Of 293 who signed informed consent, 172 were randomized into treatment groups
717024|NCT02953678|This study was conducted at 26 study centers in the United States.|
717025|NCT02953561|Recruitment Period: February 2017 to February 2019|
717026|NCT02953548|Participants were screened to assess their eligibility to enter the trial within 7 days prior to the first dose administration.|
717027|NCT02953418||
717028|NCT02953314||"This study consisted of 2-parts (Part A and B). The planned primary analysis was designed to assess overall treatment arm TEZ/IVA, irrespective of weight-based dosing regimen. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus analysis is presented for the single treatment arm TEZ/IVA."
717029|NCT02952898|"Recruitment Period: October 2016 to July 2017
~The location of clinical sites included dermatology clinics and clinical research centers."|All subjects who met the entry criteria and were randomized and enrolled into the study.
717030|NCT02952872||
717031|NCT02952820|Participants took part in the study at 119 investigative sites in Japan, Korea, Finland, Germany, Italy, New Zealand, Poland, Romania, Spain, Canada, Mexico, and the United States from 15 November 2016 to 08 January 2019.|A total of 2059 participants were screened, of which 1088 were screen failures and 971 participants were randomized to receive study treatment.
717032|NCT02952313||
717033|NCT02952261|The recruitment process was from October 15, 2016 to October 26, 2017. And, the first participant was recruited on October 24, 2016. Until reaching to 40% of prespecified sample size (Janunary 1, 2017) , interim analysis was conducted.|
717034|NCT02951988|Patients from RAP-MD-04, completed 1 of the rapastinel lead-in studies - RAP-MD-01, RAP-MD-02, or RAP-MD-03.|A total of 1304 patients enrolled in the Open Label Treatment Period (OLTP). Of these, 1056 completed the OLTP and 604 entered the Double Blind Treatment Period (DBTP) and were randomized.
717035|NCT02951884|Patients were recruited from June 2016 through May 2018 (24 months) from the Orthopaedic Surgery and Rehabilitation Center at Loyola University Medical Center.|
717036|NCT02951819||
717037|NCT02951780||Crossover study with three periods. Each participant received up to 3 doses of study drug (rGlucagon and/or LY3185643) in a dosing day as per the dosing sequence in each period with 7 to 12 days washout period.
717038|NCT02951767||The analysis included data up to cutoff date 04 July 2016.
717039|NCT02951702||
717268|NCT02920242||
717269|NCT02920177||
719144|NCT02674854||
719145|NCT02674685||
717040|NCT02951533||Total of 119 participants were enrolled and randomized, 118 (GUS [60], FAE [58 participants]) were treated in this study. Out of them, 42 participants completed study in Part III.
717041|NCT02951481|Retrospective period recruitment: 2015 (12 months). Prospective period: from February 15, 2017 to December 15, 2017 (10 months)|The initial idea was to include overall a minimun 200 patients (100 per group). As 231 patients fulfilled the criteria to be included in the retrospective arm, we finally recruited 172 patients during the prospective period (with a systematical intervention). Due to the study design, all started patients completed the study. So, counting the two groups, 403 patients started and completed the study. Neither the retrospective arm nor the prospective one suffered losses.
717042|NCT02951429||Written informed consent for participation in the study was obtained before performing any study-specific screening tests or evaluations.
717043|NCT02951351||
717044|NCT02951312||
717045|NCT02951273||
717046|NCT02951182|Of the 74 participants enrolled (47 participants in Part 1 and 27 participants in Part 2), 1 participant in Part 2 discontinued in the Run-in Period because continuation criteria were not met and was not randomized in the Treatment Period. Therefore, only 73 participants are included in the results below.|Four parts were originally planned for the study; only Parts 1 and 2 were conducted. Part 3 was removed in protocol Version 2.0. Part 4 was not conducted at the Sponsor's discretion.
717047|NCT02951156|This study included participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after completion of at least 2 and not more than 4 lines of rituximab-containing multi-agent chemotherapy (prior to this study), and/or in whom autologous stem cell transplant (ASCT) has failed, or who were not candidates for ASCT or who were not eligible for intensive chemotherapy.|This study was planned to be conducted into two phases: Phase 1b and Phase 3. Phase 3 of the study was never conducted due to early termination of study because of Phase 1b enrollment closure.
717048|NCT02951052|This was a phase III, randomized, open-label, active-controlled, multi-center, parallel-group, non-inferiority study to evaluate the antiviral activity and safety of two long-acting (LA) injectable drugs, cabotegravir (CAB) plus rilpivirine (RPV) when compared to current standard of care conducted in virologically suppressed human immunodeficiency.|A total of 618 participants were enrolled in the study. Two randomized participants did not receive study treatment. A total of 616 participants contributed to the Intent-to-treat exposed Population and Safety Population. The results presented are based on Week 48 primary analysis.
717049|NCT02950896||
717050|NCT02950831||
717051|NCT02950753||
717052|NCT02950545||
717053|NCT02950480||
717054|NCT02950025|The study opened to participant enrollment on 01/19/2017 and closed to participant enrollment on 08/13/2018.|
717055|NCT02949947|Recruitment Period: 12/2017 to 1/2019|A total of 3 participants were enrolled in the study; however only 1 started on the trial since 1 participant non-compliance and 1 participant insurance changed. Due to low accrual the study terminated early.
717056|NCT02949921|The study was conducted at 1 investigative site in the United States.|A total of 20 participants were enrolled, treated, and completed the study.
717057|NCT02949908|Two participants were enrolled and the study was prematurely terminated due to low participant recruitment.|
717058|NCT02949674|Recruitment dates: January 2017 to April 2017, at High Specialty Unit Dr. Victorio de la Fuente Narvaez, IMSS|
717059|NCT02949518||
717060|NCT02949271|The study took place at Duke University Medical Center from November 2016-November 2017.|298 were assessed for eligibility and 119 subjects were excluded due to not meeting exclusion criteria.
717061|NCT02949219||
717062|NCT02949141||All patients eligible for the study were included and received all three imaging modalities.
717063|NCT02949128||
717064|NCT02949011|This was a multicenter study conducted at 551 sites, including 242 sites in the United States, 142 sites in Japan, 48 sites in APAC (including Australia, New Zealand, Philippines, and South Korea), 98 sites in Europe (Belgium, Germany, Hungary, Latvia, Poland, Romania, and Spain), and 21 sites in South Africa.|Eligible patients were randomized in a 1:1:1 ratio to 1 of 3 treatment groups. Participants were stratified by baseline symptom score (≤ 14 or ≥ 15), preexisting and worsened symptom (Yes or No), region (Asia, North America/Europe, or Southern Hemisphere), and patient's weight (< 80 kg or ≥ 80 kg).
717065|NCT02948634||
717066|NCT02948582||All enrolled subjects were randomized. all randomized subjects received at least one dose of study medication
717067|NCT02948257||
717068|NCT02947997||No significant events occurred after participants enrollment.
717069|NCT02947984||
717070|NCT02947100||
717071|NCT02947022||
717072|NCT02946918||
717073|NCT02946580||
717074|NCT02946515|Medical and nursing students were recruited from a local university, and pediatric primary care practitioners were recruited through a local health system. All participants were recruited by email and invited to participate. Interested participants were contacted by study team members about the study and an in-person baseline visit was scheduled.|At baseline, participants reviewed and signed the consent form in-person and were given a hard copy for their records. After the baseline measurement visit, participants were randomized to either the intervention group or the wait-list control group. Due to the visit occurring in person, all participants who were consented were randomized (N=44).
717075|NCT02946489||
717076|NCT02946463||Participants were stratified into 6 groups based on transfusion history and LDH screening levels. Stratified participants were then randomly assigned in a 1:1 ratio to receive either ravulizumab or eculizumab in the 26-week Primary Evaluation Period.
717077|NCT02946385|All subjects enrolled in the study started the study.|"Participant flow,baseline characteristics & immunogenicity analyses were performed on randomized population & Safety analysis on treated population.2 subjects from Naïve_ABCWY group received rMenB+OMV vaccine & not MenABCWY.Hence,number of subjects analyzed in Naïve_B & Naive_ABCWY groups in treated population differ from randomized population"
717078|NCT02946229||
717079|NCT02946021||
717080|NCT02945657||
717547|NCT02875340|Recruitment period: 31 October 2016 - 19 June 2017|
717548|NCT02875067||
717549|NCT02875028|16 healthy volunteers participated in this crossover trial.|
717081|NCT02945410||"Participants Excluded prior to assignment:
~n = 4 did not meet inclusion criteria on preliminary questionnaires (n = 1 did not met the age requirements (reported a false age) n = 1 reported hyperthyroidism n = 2 reported insufficient levels of physical activity) n = 1 declined to participate in the study after enrolling"
717082|NCT02945254||
717083|NCT02945150||"33 patients signed consent for the study. Of those, 23 patients were deemed ready for transplant and were put on the waitlist for a HCV kidney (10 patients did not meet the readiness criteria for kidney transplantation). Of those, 8 patients were transplanted with an HCV+ kidney."
717084|NCT02945046||A total of 169 participants were randomized in a 1:1:1 ratio to placebo, fremanezumab 675 milligrams (mg)/placebo/placebo, or fremanezumab 900/225/225 mg groups.
717085|NCT02944968|A total of 51 subjects were enrolled in the study at 6 sites in Europe. The first subject was enrolled on September 28th, 2016 and the last subject was enrolled on April 26th, 2018.|Subjects were screened carefully prior to enrollment in the study to ensure compliance with the inclusion and exclusion criteria. All subjects had pre-procedure imaging to screen for the presence of left atrial appendage thrombus to decrease the potential for thromboembolic complications.
717086|NCT02944656|Participants were recruited from the Atlanta Women's Center in Atlanta, Georgia. Enrollment began on December 8, 2016 and all study procedures concluded on June 26, 2018.|A total of 122 individuals were eligible and consented to participate in the study. Six withdrew prior to randomization and an additional 2 withdrew prior to beginning the study, resulting in 114 receiving the intervention.
717087|NCT02944565|Patients were enrolled beginning in February 2017 and patient enrollment was completed in June 2017|
717088|NCT02944513||
717089|NCT02944461||
717090|NCT02944448||
717091|NCT02944383||
717092|NCT02943941||
717093|NCT02943668||
717094|NCT02943577||Prior to randomization, patients entered a 1-wk, double-blind, placebo lead-in period to identify placebo responders. Upon completion of the placebo lead-in period, patients were randomized in 1:1 ratio to receive either rapastinel or placebo. Randomization was stratified by patient's responder status (placebo non-responder vs. placebo responder).
717095|NCT02943564|658 total enrolled. 20 discontinued prior to randomization.|Prior to randomization, patients entered a 1-wk, double-blind, placebo lead-in period to identify placebo responders. Upon completion of the placebo lead-in period, patients were randomized in 1:1 ratio to receive either rapastinel or placebo. Randomization was stratified by patient's responder status (placebo non-responder vs. placebo responder).
717096|NCT02943499||
717097|NCT02943473|Participants enrolled from May 2017 through June 2019|
717098|NCT02943460|Participants were enrolled at study sites in North America and Europe. The first participant was screened on 29 November 2016. The last visit in the Blinded Study phase occurred on 28 February 2018.|105 participants were screened.
717099|NCT02943447|Participants were enrolled at study sites in United States, Canada, United Kingdom, and Austria. The first participant was screened on 01 December 2016. The last study visit occurred on 4 September 2019.|130 participants were screened.
717100|NCT02943226||
717101|NCT02943213||Study volunteers each received a single dose of 25 mg Chlorpromazine Hydrochloride Tablet in both treatment periods.
717102|NCT02943096|We will recruit subjects via advertisements for patients who feel depressed, through the RecruitMe online platform, as well as clinical referrals from colleagues around CUMC.|Every subject evaluated for this protocol will receive a clinical interview by a psychiatrist or psychologist, be administered the 24-item Hamilton Rating Scale for Depression (HRSD) and Antidepressant Treatment History Form, and have a SCID performed by a trained rater. They will be educated about appropriate treatments available for depression.
717103|NCT02942771||
717104|NCT02942654||The study consisted of two treatment periods, with a minimum of 3 days washout period between each period.
717105|NCT02942576|A total of 614 participants who met the inclusion and none of the exclusion criteria were randomized; 602 received study drug.|Participants were required to have completed between 21 to 28 days of anticoagulation with study treatment prior to the catheter ablation visit/periprocedural visit (Day 0).
717106|NCT02942485|There were no cross-over patients.|
717107|NCT02942407|Participants who met protocol inclusion criteria were enrolled (randomized 1:1 apixaban and warfarin) at clinical sites across the United States.|
717108|NCT02942160||
717109|NCT02942017|Participants took part in the study at 32 centers in United States from 25 July 2016 to 11 October 2017.|A total of 108 participants were randomized into the study to receive either placebo or SAGE-547, 104 of whom received the study drug.
717110|NCT02942004|Participants took part in the study at 32 centers in United States from 01 August 2016 to 19 October 2017.|A total of 138 participants were randomized into the study to receive either placebo or SAGE-547. Forty-three received placebo, and 79 received SAGE-547.
717111|NCT02941692||
717112|NCT02941640||
717113|NCT02941614||
717114|NCT02941146||Protocol defined inclusion and exclusion conditions determined study entry. All subjects were included in the single arm study.
717115|NCT02940886|A total of 3108 subjects were screened and 1512 subjects were randomised in the trial.|Subjects who did not have a documented history of intolerance of oral iron for at least 1 month within the last 9 months had a run-in period. During the run-in period, the subject received oral iron for up to 1 month in order to document intolerance or lack of response to oral iron.Subjects were monitored for AEs indicative of iron intolerance.
717116|NCT02940860|A total of 2560 subjects were screened and 1538 subjects were randomised into the trial.|
717117|NCT02940691||
717118|NCT02940626|Subjects were randomized at 35 centers in the United States, Austria, Czechia, France, India, Israel, Poland, Portugal, Romania, Serbia, Spain, Rep. of Georgia, and Russian Federation|Eligible subjects underwent daily screening of endotracheal aspirates to determine if they met randomization criteria. Only subjects who were randomized are included in the study analysis and summarized in the Participant Flow. A single subject was randomized/treated in a site-specific pneumonia treatment sub-study.
717550|NCT02874924||
719223|NCT02666950||Three patients were accrued. Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.
717119|NCT02940574|Participants were mainly recruited from the Expertise Centrum Autisme of the UZ Leuven between April 2015 and December 2016. Recruitment and patient contact were facilitated by our collaboration with Prof. Dr. Jean Steyaert, head of UZ Leuven ECA.|
717120|NCT02940522||
717121|NCT02940327||
717122|NCT02940249|Healthy participants were recruited from King's College London (KCL) and the general public in London and surrounding counties.|34 out of 64 screened were randomized. Of those not randomized, 8 did not meet inclusion criteria, 1 had a minor adverse event, and 21 declined to participate.
717123|NCT02939950||A total of 1632 eyes from 816 study participants were enrolled, of which 1612 eyes from 806 study participants were randomized into 1:1 to wear either the Bausch + Lomb samfilcon A soft contact lens or Bausch + Lomb pure vision soft contact lens.
717124|NCT02939937||
717125|NCT02939716|15 included in final analysis as scanner failure caused loss of data for 3 subjects|
717126|NCT02939599||
717127|NCT02939560||
717128|NCT02939326||
717129|NCT02939170|Subjects were recruited from 5 study centers located in the United States.|Of the 87 enrolled, 7 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (80).
717130|NCT02939131|Once enrollment opened (Dec 20, 2016), sites prepared lists of potential participants. The approach order was randomized in blocks of six. Sites were instructed to approach participants in order by block. A protocol letter of amendment in April 27, 2018 removed this requirement. First enrolled March 6, 2017, and the last enrolled on March 5, 2019|Sites were randomized to COMB-R or ESC with balancing based on information collected during application to participate and also in a pre-study survey, which gathered grouped data on characteristics of potential participants at each site including sex at birth, age group, mode of HIV transmission, HIV viral suppression status, level of depression.
717131|NCT02939079|The recruitment period started on April 2015. 74 patients were screened initially and 50 of them were recruited. All the patients were recruited from the neurology department of Kashani hospital, Isfahan, iran. They were patients referred to the neurology department (multiple sclerosis clinic) for evaluation and treatment.|After recruitment, no medication was prescribed for the patients for two months as the wash-out period. Then patients were assigned to study groups.
717132|NCT02939014|Participants took part in the study at 7 investigative sites in China from 07 November 2016 to data cut-off on 02 August 2018, when the last participant completed treatment (Primary Completion Date). The post-treatment follow-up is ongoing.|Participants with a diagnosis of Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL) were enrolled to receive brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion, Day 1 of every 3-week cycle.
717133|NCT02938949||
717134|NCT02938585|The trial was conducted at 10 sites in mainland China.|Study design: This was an open-label and non-randomised trial. Participants with severe haemophilia A were administered a prophylaxis (preventive) or on-demand regimen of turoctocog alfa (trial product) at the investigator's discretion.
717135|NCT02938520|This non-inferiority study evaluated antiviral activity of switching to intramuscular long acting carbotegravir (CAB) and rilpivirine (RPV) every 4 weeks compared to continuation of abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) over 48 weeks in virologically suppressed participants with human immunodeficiency type 1 infection|A total of 631 participants were enrolled into the Induction Phase of the study. 566 participants were subsequently randomized. Two randomized participants did not receive study treatment. This study was conducted in 11 countries. The results presented are based on Week 48 primary analysis
717136|NCT02938494||
717137|NCT02938169||
717138|NCT02938052||
717139|NCT02938013||
717140|NCT02937870|All participants were recruited at a single center in USA.|A total of 37 participants were screened. Out of which 23 participants were randomized in the study. 14 participants were not randomized in the study because 12 of which were screened failure, one participant withdrew consent and one participant was dismissed because number of participants required being reached.
717141|NCT02937766||
717142|NCT02937740||
717143|NCT02937701|This study was conducted at 75 centers in Australia, Bulgaria, Canada, Czech Republic, Germany, Hungary, Poland, Spain, and the United States.|"Participants were randomized in a 1:1 ratio to receive ABP 710 or infliximab, stratified by geographic region and prior biologic use.
~At week 22 participants initially randomized to infliximab were re-randomized in a 1:1 ratio to continue infliximab or switch to ABP 710. Participants initially randomized to ABP 710 continued receiving ABP 710."
717144|NCT02937636|Participants were recruited from one center in China.|A total of 343 participates were screened, out of which 128 participants were randomized in the study. 215 participants were not randomized as 186 participants did not meet study criteria, 5 participants withdrew consent and 24 were not randomized for other reasons (not specified).
717145|NCT02937623|All participants were recruited at a single center in USA.|A total of 135 participants were screened, out of which 126 were enrolled in study. 9 participants were screening failure so did not enrolled. Out of 126 enrolled participants, 120 participants were randomized. 6 participants were not randomized as 1 had adverse event, 3 withdrew from study before randomization & 2 because of unspecified reasons.
717146|NCT02937584|This study randomized 23 subjects at 2 sites in Belgium from December 2016 to May 2018.|Subjects were randomized into 1 of 2 treatment sequences. Sequence 1 received GP MDI in Period 1 followed by FF MDI in Period 2. Sequence 2 received FF MDI in Period 1 followed by GP MDI in Period 2.
717147|NCT02937558|A total of 5 subjects were randomized to active or placebo treatment during the double-blind phase of the study. All subjects completing double-blind treatment were eligible for open-label in-patient treatment with CSI Glucagon.|The first enrolled subject was not deemed evaluable for responsive to glucagon based upon prior history of glucagon resistance, per investigator.
717148|NCT02937506||
717149|NCT02937168|This study consisted of 2 parts: Part 1, a 21-day positron emission tomography (PET)/computed tomography (CT) screening period, and Part 2 (only participants with asthma), a 6-week double blind treatment/assessment period.|Participants with eosinophilic asthma were to be randomly assigned 1:1 in a double-blind fashion in Part 2 of the study to receive either placebo or reslizumab. Study was terminated prior to administration of reslizumab.
717150|NCT02936999||
719224|NCT02666846||
717151|NCT02936869|Participants were recruited from the community within 128 wards in Ebonyi State in August 2016.|Of the 269 TBAs identified through community leaders and facility heads that met the inclusion criteria and were recruited, 20 declined to participate and 27 could not be located at the given addresses.
717152|NCT02936648||
717153|NCT02936479||
717154|NCT02936076||
717155|NCT02936037||
717156|NCT02935894||
717157|NCT02935842|From May 2015 to February 2018, N=32 patients with idiopathic Parkinson's disease (PD) were recruited from the University Hospital Basel (Switzerland) and N=22 healthy controls (HC) were recruited from senior health centers or sports groups independent of the hospital.|"Eligibility assessments were conducted by neurologists, neuropsychologists and speech-language therapists. Eligibility criteria led to 12 exclusions in the PD group and to 4 exclusions in the HC group.
~Therefore, final N count for the study were: N=20 PD patients and N=18 HC."
717158|NCT02935738||
717159|NCT02935699||
717160|NCT02935673|Sponsor halted screening and enrollment in study on 22 June 2018 due to emerging lumicitabine nonclinical data. On 17 October 2018, study was stopped prematurely by sponsor as a precautionary measure, to allow further evaluation of new nonclinical pharmacokinetic (PK) and safety findings and determine their relevance to human studies.|A total of 49 participants were randomized and treated (2 participants in Part 0, 36 participants in Part 1 and 11 participants in Part 2). Analyses were conducted on pooled groups across the 3 study parts.
717161|NCT02935595||"3 subjects signed consent and were screened, but met exclusion criteria and were thus excluded from the study before starting.
~1 subject withdrew consent after screening and did not start the study."
717162|NCT02935543||
717163|NCT02935192|503 subjects were consented and screened from across 6 clinical trial sites located in Belgrade and Vrsac, Serbia. Of the 503 subjects screened, 23 subjects failed screening.|"Twenty-three (23) subjects failed screening and were not assigned to a treatment group.
~An additional 8 subjects withdrew consent prior to receiving any study product."
717164|NCT02935179||
717165|NCT02935088||
717166|NCT02935062||
717167|NCT02935036||
717168|NCT02934932||15 participants signed consent; 6 screen failed. All subjects received all three treatments with treatment order randomized within each subject.
717169|NCT02934698||
717170|NCT02934347||
717171|NCT02934191||
717172|NCT02934178|This was a single-site study conducted in Bangladesh. The study originally planned to enroll up to 64 toddlers to receive three doses of 3x10^3, 3x10^4, 3x10^5 or 3x10^6 colony-forming units (CFU) live attenuated, oral shigella WRSS1 vaccine or placebo, however enrollment was terminated after the first dose cohort was enrolled.|
717173|NCT02933879||
717174|NCT02933866||
717175|NCT02933528||
717176|NCT02933502||
717177|NCT02933476||6 subjects were enrolled, but data only collected for 5 subjects. (1 subject was enrolled but no baseline data was collected due to illness)
717178|NCT02933450||
717179|NCT02933060||
717180|NCT02933034||
717181|NCT02932943||Prior to randomization, patients entered a 1-wk, double-blind, placebo lead-in period to identify placebo responders. Upon completion of the placebo lead-in period, patients were randomized in 1:1 ratio to receive either rapastinel or placebo. Randomization was stratified by patient's responder status (placebo non-responder vs. placebo responder).
717182|NCT02932904|Participants took part in the study at 16 investigative sites in the United States from 21 November 2016 to 09 June 2017.|Healthy volunteers were randomized in a 1:1:1:1 ratio to one of 4 treatment arms: vortioxetine 10 mg, vortioxetine 20 mg, paroxetine or placebo.
717183|NCT02932891||
717184|NCT02932878||
717185|NCT02932787|Office-based workplace (UK)|
717186|NCT02932462||
717187|NCT02932306||Participants were randomized in a 1:1 ratio to receive either IDP-121(tretinoin 0.05 percent [%]) Lotion or IDP-121 Vehicle Lotion.
717188|NCT02932267||Wash-out period for topical treatment or procedures of 1 week to 3 months and for systemic treatment for 1 month to 3 months, depending on treatment
717189|NCT02932228|Recruitment into ImPACT completed by ImPACT staff at VAPAHCS|
717190|NCT02931838||268 participants were randomized in the study; One participant was randomized but did not receive study drug due to being lost to follow-up
717191|NCT02931396||
717192|NCT02931253|Study terminated prior to meeting enrollment target. Enrollment rate slower than expected.|
717193|NCT02931045||
717194|NCT02930980||
717195|NCT02930837|A total of 121 patients were screened from 11 centres across China. Of the screened patients, 1 patient did not meet the study entry criteria. The first patient visit was on 12 December 2016 and the last patient visit was on 11 December 2017.|All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated. Rescue medication was allowed for all patients as required.
717196|NCT02930590|The study took place at the Clinical Research Center for Hair and Skin Science in Berlin, Germany from September 2016 to March 2017 and involved 15 healthy female volunteers.|
717197|NCT02930226|Healthy volunteers were recruited at an academic medical center between February 2017 and March 2018. The first participant was enrolled on March 6, 2017 and the last participant was enrolled on April 5, 2018.|Of 40 screened participants, 30 met inclusion criteria and were enrolled. Six participants were withdrawn prior to receiving study treatment. Twenty four participants were infused with plasma.
717198|NCT02930174|Volunteers were solicited via word of mouth from the medical staff and the respiratory therapy staff at our university hospital. Enrollment occurred from February 1, 2018 through March 27, 2018.|All volunteers were screened for any contraindication to applying the electrical impedance tomography device (pacemaker, etc) before signing an informed consent document. No volunteer had such contraindications and all were successfully studied.
718523|NCT02738333|Participants were enrolled at study sites in Japan. The first participant was screened on 12 April 2016. The last study visit occurred on 11 May 2017.|266 participants were screened.
717199|NCT02930018|Patients with acute ischaemic stroke who were selected to undergo EVT (endovascular thrombectomy) were enrolled. The trial was done at acute care hospitals. Patients were randomly assigned (1:1) to receive a single intravenous dose of nerinetide (NA-1) or placebo. All patients underwent endovascular thrombectomy and received alteplase in usual care when indicated.|The trial drug was administered as soon as possible after randomisation.
717200|NCT02930005||
717201|NCT02929823|Patients were recruited at study sites in the USA and were assigned to study drug only if they met all the inclusion criteria and none of the exclusion criteria. Deviations from the inclusion/exclusion criteria were not permitted.|For patients using prohibited concomitant medications within 14 days prior to planned randomization date, a 14 day washout period was required prior to first dose of study drug. Patients who failed initial screening were allowed to rescreen once.
717202|NCT02929667|A total of 30 subjects enrolled from February 2017 to February 2019. These 30 subjects underwent further screening before randomization to an intervention. Eight of the subjects failed to meet eligibility for randomization to an intervention, hence only 22 participants were randomized equally (1:1) to one of the treatment arms.|A total of 6 subjects with HCVR slope of > 2.0 L/min/mm Hg were excluded.Two additional subjects did not meet other inclusion criteria for randomization.
717203|NCT02929498|This was an open-label, 2 arm study to evaluate the safety and clinical activity of GSK2879552 alone, or in combination with azacitidine in adult participants with myelodysplastic syndromes (MDS). The study was conducted in 3 centers among 2 countries.|Total 5 participants were included into Part 1 and received GSK2879552. The study was terminated during Part 1 and hence Part 2 was not conducted as the risk benefit in earlier studies do not favor continuation of this study.
717204|NCT02929407|The trial was terminated early due to low recruitment. Only four subjects were enrolled into the open-label, exploratory Part 1 of the trial (all receiving different dosing regimens), and no subjects were enrolled into the randomized, double-blind, placebo-controlled Part 2 of the trial prior to early termination.|A total of five subjects were screened, of which, four subjects were enrolled in Part 1 of the trial.
717205|NCT02928770||
717206|NCT02928536|A pilot study was conducted in Italy in November 2016. The fieldwork in other countries was conducted between June 2017 (in Romania) and October 2018 (in Latvia). The questionnaire was administered with computer-assisted personal interviewing (CAPI) through face-to-face interviews at participants' homes.|
717207|NCT02928380|Participants were recruited at a single center in the United States.|A total of 91 participants were screened, out of which only 83 participants were randomized to the study. 8 participants were not randomized: 7 participants due to screening failure and 1 participant due lost to follow up.
717208|NCT02928224|Patients were at least 18 years of age with confirmed metastatic colorectal cancer (CRC) whose disease had progressed after 1 or 2 prior regimens in the metastatic setting and whose tumor tissue was BRAF V600E-mutant as previously determined by a local assay at any time prior to Screening|
717209|NCT02928029|The study was conducted in 7 study centers, the first participant first visit was on 10/Feb/2017 and last participant last visit on 20/Mar/2019|"10 participants were screened in the study; 4 participants in Cohort 1 and 6 participants in Cohort 2. 3 of these participants failed screening procedures, all for the reason inclusion criteria not met. No participants were started in the Phase 2 part of the study prior to study termination."
717210|NCT02927938||
717211|NCT02927834||
717212|NCT02927795|"Open-label observational study, including Chronic Obstructive Pulmonary Disease (COPD) patients in Spain receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations. Questionnaire (quest.).
~10-point increase of Physical functioning questionnaire (PF10 )"|All participants were screened for eligibility to participate in the study. Participants attended primary care centres which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met.
717213|NCT02927639||
717214|NCT02927457|This was a double blind (sponsor unblinded) Phase Ib two group [group A-photoprovocation (PV) lesions and group B-natural lesions] study to investigate repeat doses of GSK2646264 administered via topical delivery, on safety, pharmacodynamic effect and clinical efficacy in cutaneous lupus participants.|A total of 11 participants were enrolled in group B in this study. No participants were randomized in group A due to PV failure and feasibility. All participants in group B received both treatment interventions at the same time (on different skin sites), hence these participants were combined in the participant flow.
717215|NCT02927431|This was a randomized study to evaluate the efficacy and safety of Danirixin (DNX) co-administered with a standard-of-care antiviral (oseltamivir [OSV]), in the treatment of adults hospitalized with influenza. The study enrolled participants in 7 centers across 3 countries (Romania,Sweden and United States) and was terminated due to poor enrollment|A total of 14 participants were screened for the study, of which 4 participants were screening failures. 10 participants received study treatment.
717216|NCT02927366|This study was conducted in 5 centers in 4 countries: Germany (2), Korea (1), UK (1) and USA (1).|Part 1 consisted of 8 subjects, randomized in a 6:2 ratio to QCC374 or placebo. The planned bid dose levels in Part 1 were 0.03 mg, 0.06 mg and 0.12 mg. Subjects began dosing at 0.03 mg bid.
717217|NCT02927327||
717218|NCT02927223||
717219|NCT02927171|Participants were recruited from a skilled nursing facility between the dates of 02.28.2016 and 10.30.2018|There were no exclusions of participants. All eligible, willing participants were allocated to one of two arms.
717220|NCT02926833|Participants were enrolled at study sites in United States. The first participant was screened on 29 September 2016. The last study visit for the primary endpoint occurred on 21 February 2019.|44 participants were screened.
717221|NCT02926638||This study was terminated early and thus no manuscript will be forthcoming. Outcomes were not analyzed.
717222|NCT02926573|The study opened to participant enrollment on 06/24/2016 and closed to participant enrollment on 06/30/2017.|13 participants were enrolled but withdrew prior to study participation with no medication given. 8 participants withdrew due to patient preference and 5 withdrew due to cancellation of surgery.
717223|NCT02926209|A total of 104 subjects were screened out of which 100 recruited into the study. Three (3) subjects were removed from the study by the physician during the procedures for medical reasons and one (1) subject did not complete the bowel preparation and was therefore excluded. One (1) subject withdrew consent prior to the procedure.|
717227|NCT02925611||60 patients were enrolled in the study and underwent randomisation to receive isolfurane or desflurane anaesthesia with 30 patients in each group.No patients were lost to follow up and all patients were analysed.
717228|NCT02925494|A total of 433 participants who completed the 6-month Treatment Period in pivotal studies M12-815 (NCT02654054) or M12-817 (NCT02691494) were enrolled in this extension study at 114 sites in 2 countries (US [including Puerto Rico] and Canada).|A total of 433 participants were treated in this extension study and were grouped according to the treatment assignments in pivotal studies M12-815 and M12-817 and this extension study.
717229|NCT02925403||
717230|NCT02925312||
717231|NCT02925117|"Participants were enrolled at 36 sites in 8 countries (Australia, Canada, Finland, Germany, Japan, Netherlands, Spain, and the United States [US]).
~The study included a 16-week double-blind treatment period (Period 1) followed by a a 72-week double-blind treatment period (Period 2) for a total of 88 weeks of treatment."|Participants were randomized in a 1:1:1:1 ratio, stratified by geographic region (US and Canada; European Union and Australia; and Japan). Participants who completed Period 1 were re-randomized at Week 16 in a 1:1 ratio within their original treatment group assignments to either upadacitinib or placebo. Rescue therapy was provided from Week 20.
717232|NCT02925078||
717233|NCT02924883||
717234|NCT02924688|Participants were enrolled from 322 centers across 15 countries.|Total 5185 participants were screened and 2436 participants were enrolled into the study and received the study treatment.
717235|NCT02924428||Eight patients signed the consent form but did not meet inclusion/exclusion criteria.
717236|NCT02924350|Participants were recruited at one center in the United Kingdom.|A total of 246 participants were screened, out of which 205 participants enrolled in the study. 41 of screened participants were not enrolled because of screening failure. Of 205 enrolled participants, 204 were randomized in study, one participant was not randomized due to lost to follow up.
717237|NCT02924051||
717238|NCT02923921||In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
717239|NCT02923895|Participants were recruited at a single clinical site in Canada.|A total of 197 participants were screened and enrolled in the study, out of which 192 participants were randomized to the study treatments. Five participants were not randomized: 1 participant was screening failure, and 4 participants withdrew their consent.
717240|NCT02923830||
717241|NCT02923427||
717242|NCT02923349|The study was conducted at 4 different sites in US, 1 site in Switzerland,1 site in Spain and 2 sites in the United Kingdom.|A total of 129 participants were screened for this study, of which 42 participants were screen failures and 87 participants were randomized to treatment.
717243|NCT02923271||
717244|NCT02923245||
717245|NCT02923115|A total of 134 participants who met all inclusion and no exclusion criteria were enrolled in the study at 47 clinic sites (15 in the United States and 32 in Europe). Of the 134 participants randomized to treatment, 125 received treatment.|This study enrolled up to 5 sequential, ascending-dose, continuous infusion cohorts (starting DS1040b dose 20 mg). In Cohorts 1 and 2, eligible participants were randomized in a 2:1 ratio to either DS-1040b or placebo. Starting with Cohort 3, the ratio changed to 3:1. All participants received standard of care enoxaparin during study drug infusion.
717246|NCT02922985||
717247|NCT02922959|Potential participants were recruited through various methods including advertisements, flyers, and word-of-mouth. Greater than 90% of participants were recruited from a syringe exchange program. All participants were given a thorough explanation of the study and signed an informed consent form.|116 potential participants were consented and screened, and 80 were randomized to Personally-tailored opioid overdose education and naloxone distribution plus Peer Intervention (PTOEND+PI) (n=40) or PTOEND (n=40).
717248|NCT02922868||
717249|NCT02922738|Provider recruitment by email invitation to Family Medicine and Adult Medicine providers at one academic medical center. 32 primary care providers (PCPs) enrolled. 989 patients with a skin problem visit to a participating PCP were identified between November 2015 to August, 2016. 433 patients participated by providing data in telephone interviews.|
717250|NCT02922582|Participants were recruited between October 28, 2016 and October 12, 2017 at 4 US sites. The study was terminated on 27-Nov-2017 due to low enrollment.|One patient was screened but was not randomized due to not meeting inclusion criteria.
717251|NCT02922153||
717252|NCT02921841||
717253|NCT02921750||
717254|NCT02921490||
717255|NCT02921425||
717256|NCT02921412||37 participants were initially enrolled (assigned a study ID), with 1 failing the screening. A total of 36 participants wore the control lens (enfilcon A toric) first and then refitted and dispensed the test lenses (fanfilcon A toric) at baseline visit. There were no discontinuations.
717257|NCT02921386||
717258|NCT02921295||
717259|NCT02921087||Forty five subjects were consented and screened. Twenty three were found to be eligible and randomized. Twenty two completed the study.
717260|NCT02921061||Though this is a dose escalation study, all patients ultimately received decitabine at the same dose (20 mg/m2) and the same additional drugs (G-CLAM) over the same dosing schedule.
717261|NCT02920983|55 subjects were recruited for the study, 51 subjects were enrolled and 50 subjects completed the initial follow up visit.|Subjects are randomized to wear each lens brand for one week in a random sequence.
717262|NCT02920970||There were 72 participants were enrolled in the study, of which 70 were dispensed a contact lens to wear and 2 failed screening.
717263|NCT02920957||There were 88 participants enrolled for this study, with 1 participant failed the screening leading to 87 who were fitted with and dispensed contact lenses.
717264|NCT02920918||
717265|NCT02920749|In this study we compared the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anaesthesia with controlled hypotension for otorhinolaryngeal surgery.|We studied patients with ASA physical status I or II, their age between was between 18 and 65 years. Individuals with a history of pulmonary, psychiatric, cerebrovascular or congenital neuromuscular disease were excluded from the study. Patients were blocked randomised to one of four anaesthetic treatment groups with closed envelops.
717266|NCT02920476||
717270|NCT02919995||16 patients were screened; six patients failed screening. Patients had to discontinue long acting bronchodilators on the day prior to screening and short acting bronchodilators for 8 hours before all spirometry assessments
717271|NCT02919826||
717272|NCT02919813||
717273|NCT02919761|A total of 259 patients were recruited at 80 study centers globally for Part 1. Of those participants, 77 were randomized to receive Acthar and 77 were randomized to receive Placebo for an additional 12 weeks, which was Part 2.|All participants enrolled in Part 1
717274|NCT02919696||Participants who completed were those who had progressive disease or died due to any cause while on treatment. Pharmacokinetic (PK) samples were collected at lower doses during cycle 1.
717275|NCT02919683||
717276|NCT02919657|Open call for bariatric patients via social media and direct mail marketing.|
717277|NCT02919618|Twenty-one patients were consented between July 11, 2016 and December 20, 2017. These patients were evaluated as either inpatient or outpatient. Once patients met initial enrollment criteria, screening procedures were conducted to determine if the patient was eligible for SBRT.|"Nineteen patients were consented, screened, and deemed eligible for SBRT.
~Two additional patients signed consent and went through screening procedures; however, were later deemed ineligible to obtain SBRT."
717278|NCT02919423||5 subjects were consented but did not meet eligibility criteria and were not randomized to a condition.
717279|NCT02919267|As mentioned into the Methods section of the protocol, each patients that were excluded after randomization were replaced by a new randomized patient. We had to randomized 49 patients in order to analyze a total of 39 patients.|One patient was excluded after the study was completed because when we started the analysis of the results, we realized that one of the patient had an air leak during the study period that was not recognized by the investigator. Since the study was completed, we could not randomized a new patient.
717280|NCT02919111||
717281|NCT02919007||
717282|NCT02918773|Twenty-two volunteer clinicians were randomly assigned to use either a smartphone otoscope device or a conventional otoscope for a six-month period from October 15, 2016 to April 15, 2017. This study was conducted at two children's hospital emergency departments in Atlanta, Georgia.|Study clinicians logged 1,502 encounters where otoscopes were used; 112 (7%) of encounters were excluded due to incomplete data or not meeting study inclusion criteria, for a total of 1390 encounters evaluated.
717283|NCT02918669||
717284|NCT02918656||
717285|NCT02918630||
717286|NCT02918617||
717287|NCT02918552||
717288|NCT02918396||
717289|NCT02918357||
717290|NCT02918318||
717291|NCT02918279|This trial was conducted at 32 sites in 5 countries: Belgium (6 sites), Sweden (4 sites), Russia (8 sites), Mexico (2 sites) and the United States of America (USA - 12 sites). Additionally, 1 site in the USA was approved by the independent review board, but did not randomise any participant.|This trial consisted of a 12-week run-in period, during which participants received counselling on healthy nutrition and physical activity. Completed numbers include participants who completed the trial without prematurely discontinuing the trial product and participants who discontinued the trial product but came for the week 82 follow-up visit.
717292|NCT02918266|Participants took part in the study at 1 investigative site in the United states from 21 November 2016 to 08 August 2017.|Healthy male participants were enrolled in this 2-part study to receive: TAK-071, scopolamine in Part 1; TAK-071, scopolamine and donepezil in a cross-over sequence in Part 2. The study was terminated prior to start of Part 2 intervention period 2 due to indication change.
717293|NCT02918097||
717294|NCT02918071||121 participants receive treatment with benralizumab 30 mg at every 4 weeks schedule.
717295|NCT02917941|Participants took part in the study at 16 investigative sites in Japan from 01 November 2016 to 31 August 2019.|Participants with confirmed MM, who received 1-3 lines of prior therapy, received ixazomib 4 mg + lenalidomide and dexamethasone in this study, followed by progression free survival (PFS) and overall survival (OS) follow-up.
717296|NCT02917642||Patients who had received endodontic intervention or declined to participate before assignment: 16 out of 66 patients were excluded from this study.
717297|NCT02917603||
717298|NCT02917447||
717299|NCT02917265|Participants were recruited at the Rheumatology Research Clinic of the Oklahoma Medical Research Foundation between 9.2015 and 5.2017.|Screening and randomization occurred at the same visit. One individual failed screening due to severe depression.
717300|NCT02916927||62 rather than 56 patients were enrolled because we were concerned about participants not completing the study.
717301|NCT02916745||
717302|NCT02916563||
717303|NCT02916498||16 subjects were enrolled in the study. 10 were withdrawn prior to randomization. 6 were randomized. Statistically relevant conclusions cannot be made from this small sample size.
717304|NCT02916433||
717305|NCT02916407||A total of 56 patients were enrolled in this study and no patient was dropped.
717306|NCT02915978||
717307|NCT02915874||
717308|NCT02915835||
717309|NCT02915783|Participants took part in the study at 8 investigative sites in the United States.|A total of 41 participants were enrolled and screened, of which 10 were screen failures and 31 participants received the study treatment. Data in this result summary have been reported at primary completion date (17 Jul 2019).
717310|NCT02915705||Eligible participants discontinued oral phosphate and active vitamin D therapy for 7 days prior to randomization. Participants were then randomized 1:1 to receive either open label burosumab administered by subcutaneous (SC) injection every 2 weeks (Q2W) or phosphate and active vitamin D therapy administered orally daily for a total of 64 weeks.
717311|NCT02915302|Study participants were enrolled in 38 centers in the United States from 23 September 2016 to 02 January 2017.|A total of 1950 participants were randomized in the study.
717312|NCT02915159||250 enrolled; 188 Randomized, 62 not Randomized:Reasons Not randomized: 6 withdrew consent, 1 lost to follow-up, 49 no longer meet study criteria, 6 screening failures
717313|NCT02915029||
717314|NCT02915016||
717315|NCT02914795||
717316|NCT02914548||
717317|NCT02914457||
718524|NCT02738255||
717318|NCT02914275|Subjects were enrolled from 27 September 2016 to 11 August 2017 from 39 study sites in the United States of America.|A total of 2339 subjects were screened. A total of 2250 subjects were randomized to study treatment. Due to not having valid informed consent, 3 subjects were removed from the clinical database. Therefore, overall 2247 subjects gave informed consent and were included in the analysis set.
717319|NCT02914236|Patients in the specialist's clinic with symptoms associated with nasal airway obstruction were approached for possible participation. Following completion of the informed consent process, baseline evaluation was conducted.|Four potential subjects failed to meet one or more of the inclusion/exclusion criteria. One additional subject met all criteria, but other health issues precluded commitment to the study.
717320|NCT02914210||
717321|NCT02914184|The study was conducted at 66 centers in 8 countries: 2 in Costa Rica, 10 in Finland, 6 in Germany, 7 in Japan, 6 in Republic of Korea, 9 in Spain, 6 in Taiwan and 20 in the United States (US).|Among 1612 subjects enrolled in the study, 1600 were vaccinated and 1545 completed the study.
717322|NCT02914132||
717323|NCT02914119||Estimated number of included cases
717324|NCT02913326|This is a randomised, open-label, exploratory trial with blinded endpoint adjudication (PROBE [prospective, randomised, open-label, blinded endpoint] design), comparing efficacy and safety of oral dabigatran etexilate versus oral warfarin in patients with cerebral venous and dural sinus thrombosis over a 24-week period.|All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that they (all participants) met all inclusion/exclusion criteria. Participants were not to be randomised to trial treatment if any one of the specific entry criteria were not met.
717325|NCT02913222||
717326|NCT02913105|The study was conducted in 25 centers across 6 countries.|A total of 121 participants were enrolled in the study, and included in the safety population. Placebo data have been pooled from placebo treated participants from both cohorts (100 mg and 50 mg matching placebo).
717327|NCT02912650||
717328|NCT02912468|Participants were involved in the study from 05 December 2016 to 05 July 2018 at 67 active centers in 13 countries. A total of 506 participants were screened, of which 276 participants were enrolled and randomized to receive dupilumab 300 mg or placebo. A total of 230 participants failed screening mainly due to failure to meet inclusion criteria.|Randomization was stratified by the presence of comorbid asthma and/or non-steroidal anti-inflammatory drug exacerbated respiratory disease (NSAID-ERD), prior nasal polyposis (NP) surgery (yes or no), and country.
717329|NCT02912455||
717330|NCT02912364||
717331|NCT02912195||
717332|NCT02911948|The trial was conducted at 38 sites in Japan as follows: 38 sites screened and 37 sites randomised subjects.|
717333|NCT02911922|One patient was enrolled on this study overall.|
717334|NCT02911909||
717335|NCT02911857||Participants with Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome (also known as mevalonate kinase deficiency (HIDS/MKD), or colchicine resistant/intolerant Familial Mediterranean Fever (crFMF) received study drug based on the final dose regimen received in CACZ885N2301 (NCT02059291).
717336|NCT02911844||
717337|NCT02911818|This trial enrolled 150 participants for the original 52-week study. The 12-week extension study randomized 45 participants from the 100 eligible from the original 52-week trial who were originally in either the CMS-Liraglutide or Multi-Component groups. Eligible participants for the 12-week extension had to complete 1 year on liraglutide.|
717338|NCT02911753||
717339|NCT02911688|Volunteers were screened for eligibility between September 2016 and November 2018 at the Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina at Chapel Hill.|18 volunteers were randomized
717340|NCT02911519|The participants were selected from the users who attended ambulatory control in the Comprehensive Mental Health Clinic that serves Colombian health care users. Through telephone call and referral by treating psychiatrists, those users who, due to clinical history, were diagnosed with schizophrenia, were invited to participate.|
717341|NCT02911324||
717342|NCT02910739||Per protocol, this study was divided into Part I and an optional Part II, with Part II initiating only after interim analysis (IA) of Part I. Following Part I IA, the pharmacokinetic (PK) criterion necessary to initiate enrollment for Part II was not met. As a result, the study was completed normally without enrollment into the optional Part II.
717343|NCT02910713||Intranasal and Extranasal data for this crossover study are combined because there is only access to combined arm data for this study. The study was acquired from another organization and limited results data are available.
717344|NCT02910362|From September 2016 until December 2016,15 patients were enrolled at Arizona Eye Consultants clinic|Patients were included in the study based upon meeting inclusion criteria and not meeting exclusion criteria. Patients were randomized to either group based upon a random number generator.
717345|NCT02910167|Observational prospective study to evaluate adverse events (AEs), Risk factors and drug utilization of Buscapina Compositum N in adults from metropolitan lima|All patients were screened for eligibility to participate in the trial. Patients attended one of 4 specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria was violated.
717346|NCT02910102||68 participants signed consent and were screened for participation. Of these, 40 entered a 2-week single-blind placebo run-in period with treatment with placebo qd. Subjects were allowed to re-screen if they failed the initial screening assessments. All subjects deemed eligible following run-in were randomized to a treatment group.
717347|NCT02910089|Potentially eligible patients for inclusion in this study were those who: (1) were ≥18 years of age, (2) had filled a prescription for 1 or more oral hypoglycemic agents within the prior 12 months, and (3) had evidence of poor glycemic control (A1C ≥8%) within the previous 6 months.|Patients were excluded if, prior to identification, they had fewer than 3 months of continuous enrolment in the health plan, had recently filled insulin or had no available telephone contact information.
717348|NCT02910011|23 were consented but 15 assigned to receive the intervention|
717349|NCT02909959||
718525|NCT02738203||
719556|NCT02633358|Recruitment period: 2015 Jan. to 2018 Apr. Types of location: Cardiac intensive care units, China Medical University Hospital, Taichung, Taiwan|
717350|NCT02909907|This was a 12-week, pilot, randomized (1:1 ratio), double-blind, placebo-controlled study of 21 patients with ET evaluated by a movement disorders specialist at the Cleveland Clinic.|Twenty-one patients were enrolled to participate, but one patient was removed from the sample due to being an extreme outlier on most outcomes of interest, and another patient dropped out after the baseline visit.
717351|NCT02909764|Mothers were recruited from a list of past participants in our research program who asked to be contacted for future studies. Study was conducted at The Monell Chemical Senses Center in Philadelphia, Pennsylvania USA in 2016.|Children were randomized at the beginning of the first test session. There were no significant effects that occurred after participant enrollment but before randomization to study group.
717352|NCT02909504||
717353|NCT02909439||18 patients were excluded after enrollment. The reasons were (1) no longer met inclusion criteria (n =10), declined to participate (n=3), change in surgical date & logistical issues (n=5)
717354|NCT02909153||
717355|NCT02909140||Although 3 patients were enrolled, no information is available for the 3rd patient. Hence, the discrepancy.
717356|NCT02909101||
717357|NCT02908880||
717358|NCT02908841|43 patients were enrolled in the study, 21 patients were excluded due to lack of intraoperative bleeding.|
717359|NCT02908672||22 participants in the experimetal arm stopped treatment during the run-in period and received no atezo. 4 more in the experimental arm completed the run-in period but did not receive atezolizumab and were included in the safety population. 3 participants from the control arm were not treated with either cobimetinib or vemurafenib.
717360|NCT02908620|Study conducted at the University of Pennsylvania School of Dental Medicine. 240 South 40th Street, Robert Schattner Center, Philadelphia, PA 19104. Recruitment was from normal volunteers.|
717361|NCT02908529||
717362|NCT02908516||
717363|NCT02908464||After participant enrollment, a baseline cognitive assessment was performed using the Montreal Cognitive Assessment (MoCA). If the patient achieved a score indicating the presence of severe baseline cognitive impairment (<10), they were subsequently withdrawn.
717364|NCT02908347||
717365|NCT02908269|Study participants were enrolled in 2 centers in the United States from 15 September 2016 to 28 September 2016.|A total of 180 participants (60 for each group) were enrolled and vaccinated in the study.
717366|NCT02908178|Because this study is 1) secondary data analysis of an existing database, 2) has two aims using the most recent data when conducting the analyses, and 3) uses Mehalanobis matching, the number of participants in Enrollment is the number of patients who are eligible to our inclusion criteria.|
717367|NCT02908100|The study was conducted at 69 centers in 12 countries.|An overall total of 616 participants were screened into the study, of which 356 participants were screen failures. 260 participants (Intent-To-Treat/ITT population) were randomized into the study, of which 1 participant did not receive any study treatment meaning that the Safety population consisted of 259 participants.
717368|NCT02907892||
717369|NCT02907814|Ophthalmology clinic, Newark, New Jersey, from 10/26/2016 to 4/1/2018|
717370|NCT02907619||Study B5161004 was an open-label extension (OLE) to study B5161002. The parent study B5161002 was a Phase 2, randomized, 2-period, blinded, placebo controlled study to evaluate the safety, efficacy, PK and PD of domagrozumab administered to ambulatory boys diagnosed with DMD.
717371|NCT02907489||
717372|NCT02907463||
717373|NCT02907268||
717374|NCT02907216||Out of the 292 subjects enrolled in the study, the first 73 subjects enrolled into each of the 2 study groups (total of 146 subjects) were allocated to the HRV immunogenicity sub-cohort to evaluate immunogenicity of the liquid HRV vaccine.
717375|NCT02907073||
717376|NCT02906930|The trial was conducted at 93 sites in 9 countries as follows: Algeria: 4 sites screened/4 sites randomised subjects; Bulgaria: 3/3; Czech Republic: 5 /5; Japan: 6/6; Mexico: 2/2; Russian Federation: 9/9; Serbia: 3/3; Turkey: 7/7; United States: 53/48.|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
717377|NCT02906917|The trial was conducted at 71 sites in 7 countries, as follows: Algeria (4), Czech Republic (6), India (10), Russian Federation (11), Serbia (5), Turkey (7), and United States (28). Additionally, 1 site in the United States screened, but didn't randomise any subject.|
717378|NCT02906813|Participants took part in the study at 1 investigative site in the United States from 12 September 2016 to 09 November 2016.|Healthy participants were enrolled in 1 of the 3 treatment sequences that determined the order of the three treatments received: TAK-935 300 milligram (mg) tablets in fasted state, TAK-935 300 mg tablets in fed state and TAK-935 300 mg solution in fasted state.
717379|NCT02906709||
717380|NCT02906696|Recruitment Period: October 2016 to November 2018|
717381|NCT02906670|Patients were only recruited for Part 1; a recommended Phase 2 dose (RP2D) could not be established and the part 2 cohorts A, B, C and were not initiated.|
717382|NCT02906644|Recruitment began on 11/8/2016 and ended on 2/20/2018. Of the 97 subjects (subjs.) consented during this period, 61 subjects met all study criteria, attended the first study visit, were randomized and received study intervention.|Of the 97 subjs. enrolled, 36 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1): 14 did not meet inclusion criteria, 16 met exclusion criteria, 3 were unable to meet study requirements, 2 were excluded due to laboratory values, and 1 was excluded by the medical staff.
717383|NCT02906579||
717384|NCT02906566||110 participants were consented; 34 participants were assigned to a study arm.
717385|NCT02906358||
717386|NCT02905981||
717387|NCT02905825||One subject (or parent) signed the consent, but before washout period was completed, decided to withdraw from trial. Therefore, from the 54 consented, only 53 started the study procedure.
717388|NCT02905331||
717389|NCT02905266||106 participants were randomized and treated.
717390|NCT02905149||
718632|NCT02728206|Participants were enrolled at a study site in New Zealand. The first participant was screened on 12 June 2016. The last study visit occurred on 16 January 2018.|11 participants were screened.
718633|NCT02728089||
717391|NCT02905006|The study started to enroll participants in August 2016 and concluded in July 2017.|"The study included a 2-4 week Screening Period and a 12-week Treatment Period. Completed study was defined as completed the 12-week double-blind Treatment Period. After Treatment Period participants either enrolled in an extension study (PS0011) or entered a 20-week Safety Follow-Up Period.
~Participant Flow refers to the Randomized Set."
717392|NCT02904915||
717393|NCT02904902||
717394|NCT02904356||
717395|NCT02904265|Study closed due to only 3 participants recruited|Study closed due to only 3 participants recruited
717396|NCT02904096|The study was conducted at 9 investigational sites in the United States.|A total of 256 subjects were enrolled and treated, out of which 216 subjects completed the study.
717397|NCT02904057|The study was conducted at 2 sites in Canada.|A total of 29 participants were screened for the study and all 29 participants were enrolled and treated.
717398|NCT02903966|This study evaluated the safety and tolerability of repeat oral doses of GSK2982772 60 milligram (mg) or placebo three times daily (TID) in Part A (double blind [DB]) followed by GSK2982772 60 mg TID in Part B open label extension (OL) in active ulcerative colitis (UC) participants.|A total of 77 participants were screened, of which 36 eligible participants were enrolled (41 were screening failure). All 36 participants were randomized to receive GSK2982772 60 mg or Placebo in Part A of the study.
717399|NCT02903836|2 subjects withdrew consent prior to receiving study drug and 7 subjects whose PK results showed no detectable level of either nafithromycin or moxifloxacin hence 9 subjects excluded from the Safety population.|
717400|NCT02903420|Thirty-eight subjects were consented to the trial. Two subjects withdrawn from the study prior to the TAVI procedure. One subject had a gastrointestinal bleed prior to the procedure and the other subject had surgery per the decision of the surgeon.|"Eight of the 36 subjects were treated as bailout due to the non-nominal volumes. The primary analysis was performed on the patients with nominal volume (n=28)."
717401|NCT02903407|Patients were recruited from the Duke CICU between September 1, 2017 and June 30, 2019. Patients were identified by the rounding team for potential inclusion in the sedation trial and then screened by study team members to determine whether they met inclusion criteria. Consent was obtained from eligible patient's primary decision maker.|No enrolled participants were excluded from the study prior to group assignment.
717402|NCT02903394||
717403|NCT02903238||
717404|NCT02903121||
717405|NCT02903030|13 participants were screened and randomized to be in the study at the OSU Wexner Medical Center, Nisonger Center in 2016.|13 patients were randomized to order, but 3 dropped out because of distance and transportation without providing any follow-up data, leaving 10 who progressed through to study completion. (77% retention rate)
717406|NCT02902965||
717407|NCT02902913||
717408|NCT02902809|Adult participants with asthma inadequately controlled on inhaled corticosteroid plus long-acting beta 2 agonist were recruited at 4 sites in Japan from 01 November 2016 until study termination on 24 January 2018. No adolescent participants were enrolled in the study.|Of all enrolled participants, 3 were considered screen failures and 28 participants were received study treatment. Following initial screening, there was a run-in period of up to 2 weeks to allow adequate time for eligibility criteria to be evaluated prior to entry to planned 52-week treatment period followed by a 14 week extended follow-up period.
717409|NCT02902770||
717410|NCT02902237|All patients were recruited in the University Hospital Muenster on an out-patient basis.|24 patients were screened, 6 were screening failures(1: fast disease progression, 1: retraction of consent; 3: fast disease progression, 1: new brain metastasis diagnosed in screening). One patient died from sepsis before treatment with tTF-NGR, 17 patients obtained at least 1 application of tTF-NGR and were evaluable for safety, toxicity ans efficacy.
717411|NCT02902172||
717412|NCT02902146||
717413|NCT02902081||
717414|NCT02901951|Subjects aged between and including 40 to 60 years were enrolled in this study, in compliance with the inclusion criteria, which required the documented evidence of previous vaccination with three or four consecutive doses of Engerix-B administered in adulthood (i.e. at least 18 years of age).|106 subjects were enrolled in the study but 3 subjects were withdrawn before vaccine administration. Therefore, the number of subjects started is 103.
717415|NCT02901249||
717416|NCT02901080||All 161 participants who enrolled in the study began the treatment.
717417|NCT02901054|19 consented, 3 participants withdrew prior to any intervention, and 1 participant excluded before outcomes data collection|
717418|NCT02900781|Consented participants|StudyTerminated- device not working
717419|NCT02900378|This study was conducted at 120 centers in 19 countries worldwide (Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Netherlands, Norway, Poland, Spain, Sweden and UK).|It was planned to recruit 300 patients per treatment arm, i.e. 600 patients in total. A total of 764 patients were screened, of whom 621 patients were randomized (310 in the sacubitril/valsartan group and 311 in the enalapril group).
717420|NCT02900170||
717421|NCT02900092||
717422|NCT02899988||
717423|NCT02899962||722 subjects were screened of which 650 subjects were assigned to treatment with LEO 90100 open-label phase. Subjects did not progress from screening due to adverse event=1, lost to follow-up=2, other reasons=2, screening failures=52, and withdrawal by subject=15. All 650 subjects were exposed to LEO 90100 during the open-label phase
717424|NCT02899884|Participants took part in the study at 32 investigative sites in Spain from 14 November 2016 to 16 July 2018.|Participants with a diagnosis of cancer pain were enrolled and observed to characterize the participants with breakthrough pain.
717425|NCT02899689|From November 2016 to February 2018 at UTMB Galveston|
717426|NCT02899377|This was a pilot imaging study using positron emission tomography (PET)/computed tomography (CT) and multi parametric magnetic resonance imaging (MRI) to investigate the potential to characterize and quantify disease manifestation in primary Sjögren's syndrome (pSS) participants.|A total of 25 participants were enrolled in the study. The study was conducted at 3 centers in the United Kingdom.
717427|NCT02899338||Subjects were randomized in 1:1 ratio to receive BI 695501 (autoinjector) or BI 695501 (prefilled syringe).
717428|NCT02899156||
717429|NCT02898974||
717430|NCT02898740||
717431|NCT02898662|This study was conducted at 16 centers in 4 countries (Hungary, Poland, Denmark and Sweden) between 12 October 2016 and 25 September 2018. Participants with eosinophilic moderate to severe asthma on a maintenance treatment of controller inhaled corticosteroids (ICS) + long-acting β2 agonists (LABA) and no other controller medication were recruited.|The study had a screening period (2-4 weeks), a 12-week dosing period and an observation period (up to 40 weeks). A total of 81 participants were randomized in this study to test the hypothesis that AZD1419 provided sustained asthma control in eosinophilic asthma participants after removal of ICS and LABA medication.
717432|NCT02898597||
717433|NCT02898454|Study participants were involved in the study from 28 November 2016 to 16 November 2018 at 117 centers in 14 countries. A total of 806 participants were screened, of which 448 participants were enrolled and randomized to receive dupilumab 300 mg or placebo. A total of 358 participants had screen failures due to failure to meet inclusion criteria.|Randomization was stratified according to asthma and/or non-steroidal anti-inflammatory drug exacerbated respiratory disease (NSAID-ERD) history (yes/no), prior nasal polyps (NP) surgery (yes or not), and country.
717434|NCT02898116||
717435|NCT02897349|This was a randomised, double-blind, multi-centre, and placebo-controlled, parallel group study to compare linagliptin with placebo as add-on therapy to stable insulin alone (basal insulin, premixed insulin) or in combination with metformin in Chinese type 2 diabetes mellitus (T2DM) participants with insufficient glycaemic control.|All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
717436|NCT02897141||
717437|NCT02897115|The study planned to enroll approximately 240 participants at 30 sites in Germany. Due to slow enrollment the study was terminated prematurely; at the time the decision to close the study was made 22 subjects were enrolled at 9 sites in Germany.|
717438|NCT02896907||
717439|NCT02896855||
717440|NCT02896595||
717441|NCT02896569||
717442|NCT02896400||
717443|NCT02896361|29 patients were screened for elegibility between july 2016 and may 2017 Dusseldorf (GER) and Wilrijk (BEL)|27 of the 29 participants received the study intervention. Of those did not receive study intervention, 1 did not meet inclusion/exlusion criteria and 1 was withdrawn for non compliance.
717444|NCT02896296||A total of 208 subjects were screened across 25 sites, and of those, all 208 subjects entered the treatment period and received at least 1 dose of RBP-6000.
717445|NCT02896127|The majority of subjects completed 52 weeks of treatment. After Week 16 all participants originally assigned to placebo switched to AIN457 150 mg s.c. Four out of the 153 assigned to the placebo group discontinued before Week 16.|All patients independent of completer status were asked to enter follow up whenever they exited the study no matter at what time in their participation. Moreover, not all participants who completed Week 52 entered the follow up period and some did not complete follow-up. Therefore, the number of participants who started the follow-up period is not equal to the number of participants who completed the previous period.
717446|NCT02895347||Of the 40 subjects who consented to participate in the study, 4 subjects failed to complete study procedures and dropped out of the study. Reason for this included inability to attend the final assessment and subjects unwilling to perform the final study assessment on a live porcine model.
717447|NCT02895295||
717448|NCT02895035|All patients who presented to one of two attending ophthalmologist's (MCC or SMP) clinics at Penn State Eye Center for cataract evaluation between November 10, 2016 and February 8, 2018 and met inclusion/exclusion criteria were invited to participate in the study. There were no incentives provided to patients for enrolling in the study.|
717449|NCT02894840||A total of 340 participants (40 in phase I and 300 in phase II) who met all inclusion criteria and not of the exclusion criteria were enrolled in the study.
717450|NCT02893878||The study included vaccinated subjects only.
717451|NCT02892734|The study opened to accrual on September 5, 2017 with a total accrual goal of 29. The first patient started treatment October 18, 2017. The study was closed permanently January 21 2019 with 3 patients treated on study.|
717452|NCT02892513||
717453|NCT02892500||
717454|NCT02892448||
717455|NCT02892422||"Participants who had completed either study 16159A or 16323A were enrolled. Participants from study 16323A were excluded from the all patients treated dataset and from the full analysis dataset."
717456|NCT02892409|Participants took part in the study at 1 investigative site in Korea from 05 September 2016 to 11 May 2017.|Participants with diagnosis of positive helicobacter pylori (HP) were enrolled in 1 of the 2 treatment groups to receive: Clarithromycin + Amoxicillin + Tripotassium Bismuth Dicitrate (Bismuth) + Lansoprazole twice daily or Clarithromycin + Amoxicillin + Bismuth + TAK-438 twice daily.
717457|NCT02892344||
717458|NCT02892110||
717459|NCT02892019||randomized set : 80 participants (41 and 39) Full analysis set : 79 participants (41 and 38) safety set : 79 participants (41 and 38) per protocol set : 35 participants (35 and 34)
717460|NCT02891863||
717461|NCT02891629||Investigator decided to terminate subject participation due to the discovery of cataract during the trial.
717462|NCT02891408|Participants were enrolled at study sites in United States. The first participant was screened on 23 September 2016. The last study visit occurred on 13 May 2019.|In the control groups (normal hepatic function), each participant was matched for age, gender, race, and body mass index with a participant in the hepatic impairment group. 14 total unique participants with normal hepatic function were enrolled in Cohort 1 (N = 10) and Cohort 2 (N = 4). 6 participants with normal hepatic function from Cohort 1 also served as matched controls in Cohort 2.
717463|NCT02891200||
717464|NCT02891174||"74 women were consented prior to delivery.
~Women were subsequently excluded due to cesarean delivery (n=20), severe features of preeclampsia (n=7), additional anesthesia (n=2), and delivery physician preference (n=2).
~43 women were randomized. Six women declined study medication and were not included in intention-to-treat analysis."
717465|NCT02891070||
719753|NCT02612610||Of 367 screened, 253 were randomized to treatment with placebo or 7.5 mg, 20 mg, or 50 mg gefapixant. One participant randomized to receive 7.5 mg gefapixant was discontinued before receiving treatment.
717466|NCT02890992|The study was conducted at 16 sites in 10 countries. Overall 63 participants were screened between 15 September 2016 and 13 June 2018, of whom 21 participants were screen failures. Screen failures were mainly due to exclusion criteria met.|A total of 42 participants were included in this study.
717467|NCT02890381|Recruitment period was from September to October 2016. Participants were recruited from medical clinics.|
717468|NCT02890355|The trial was designed to enroll 143 patients, but was closed early based on the results of a planned interim futility analysis. Thus, only 123 patients were enrolled on the study.|123 participants were enrolled, but 4 were ineligible and 2 refused assigned FOLFIRI treatment. Thus, 117 were eligible for analyses.
717469|NCT02890303|This study enrolled patients at 8 clinical study sites, with symptomatic age-related lens cataract desiring lens extraction and IOL implantation. The last patient was enrolled in the study in December 2016.|
717470|NCT02889900|Patients with platinum-resistant relapsed high grade serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal carcinoma who had received at least 3 prior lines of therapy for advanced ovarian cancer were recruited to 25 study centers in the United States in this single arm, open-label Phase IIb study.|Patients had no evidence of deleterious or suspected deleterious germline breast cancer susceptibility gene (gBRCA) mutations. Patients had to have measurable disease, defined as ≥1 lesion that could be assessed at baseline by computed tomography / magnetic resonance imaging and be suitable for repeated assessment.
717471|NCT02889861|Eligible participants have tolerated IMCgp100 (77 kDa bi-specific protein) for a minimum of 4 weeks of dosing without significant toxicities that would preclude further dosing in the opinion of the principal investigator or Sponsor.|Participants were eligible for enrollment in this study from parent studies that have completed and satisfied its primary endpoints or have been terminated by the Sponsor for reasons other than safety.
717472|NCT02889289|One Veteran recruited from Polytrauma department of Washington DC VA Medical Center during April 2015.|
717473|NCT02888756||
717474|NCT02888691||
717475|NCT02888171|Participants were recruited from the nephrology outpatient clinics at the University of Alabama at Birmingham (UAB) from September 2016 to October 2018.|Participants who were taking oral iron supplements at the time of the screening visit were allowed to participate but had to undergo a wash-out period of at least 4 weeks prior to randomization.
717476|NCT02888093||
717477|NCT02888080||"Safety Analysis set : 20 patients ACZ885 and 20 patients Placebo
~PK Analysis set : 20 patients ACZ885
~PD Analysis set : 20 patients CAZ885 and 20 patients placebo"
717478|NCT02887989||
717479|NCT02887521||
717480|NCT02887404||
717481|NCT02887183|Of 1031 patients screened for the study, 795 completed screening and were enrolled. One (1) patient completed screening but withdrew consent and did not enter the treatment phase. Therefore, the Full Analysis Set and the Safety Set was based on 794 patients.|
717482|NCT02886923|A total of 24 subjects were enrolled into this study. Of the enrolled subjects 23 were dispensed a study lens while 1 subject failed to meet all eligibility criteria. Of the dispensed subjects, all 23 completed the study.|
717483|NCT02886715|At Baseline Visit eligible subjects were randomized to the Test, Reference or Placebo product in a 2:2:1 ratio using an interactive response technology (IRT) system|"1154 subjects were screened for study participation, 1110 subjects were randomized and included in the statistical analyses.
~25 investigative sites randomized subjects into the study."
717484|NCT02886702|At Visit 1, eligible subjects were randomized to the Test, Reference or Placebo product in a 1:1:1 ratio using an interactive response technology (IRT) system.|"927 subjects were screened for study participation, 855 subjects were randomized and included in the statistical analyses.
~29 investigative sites (one with two locations) randomized subjects into the study."
717485|NCT02886624|Recruitment occurred between May 31, 2017 and August 20, 2019. Recruitment took place at 6 university hospitals in France (Paris, Lyon, and Nice). 33 individuals were assessed for eligibility and 3 did not meet inclusion criteria.|
717486|NCT02886338||
717487|NCT02886234||Prior to being randomized, patients had to complete all baseline activities, which included two months of counting to establish a baseline adherence measure. During this interval, 6 patients withdrew from the study. Thus, 44 patients were randomized (24 to health coaching arm, and 20 to the mindfulness training arm).
717488|NCT02885636||
717489|NCT02885506||
717490|NCT02885246|This is a database study with no subject enrollment. The seasonal influenza A and/or B cases reported in the study centers were recorded in country specific national influenza surveillance program databases. Data were not available for selected countries of Central America and the Caribbean. Therefore,only data from Panama were analysed.|All data was taken from the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES) database of Panama, from January 2011 to December 2017. Based on the dates of data transfer and data availability, the data collection period was updated as January 2011-December 2017 instead of January 2010-December 2015, previously defined per protocol.
717491|NCT02885181|Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 21 September 2016. The last study visit occurred on 20 September 2017.|140 participants were screened.
717492|NCT02885025|Patients were recruited from the VA Greater Los Angeles Healthcare System Allergy Immunology Clinic|
717493|NCT02885012||
717494|NCT02884492||
717495|NCT02884427||
717496|NCT02884089|Participants were randomized to one of the four sequences and received either placebo or Abemaciclib along with Metformin or Iohexol. A washout period of at least 16 days following Abemaciclib administration & at least 5 days following placebo administration occurred between each period.|Follow-up visit of 16 to 20 days occurred after administration of the last dose of study drug.
717497|NCT02883452|For Part 1, participants were screened from 21 study centers in 9 countries and were enrolled from 20 study centers in 9 countries. For Part 2, participants were screened from 62 study centers in 16 countries and were enrolled from 50 study centers in 15 countries.|For Part 1, a total of 55 CD patients were screened, 45 patients were enrolled (10 screening failures) and 44 patients were randomized. For Part 2, a total of 195 CD and UC patients were screened, 136 patients were enrolled (59 screening failures) and 131 patients were randomized.
719754|NCT02612428||
719755|NCT02612285||
719756|NCT02612155||
717498|NCT02883244|This study enrolled subjects with signs and symptoms of gingivitis and no or little experience with inter-proximal cleaning device in the single center.|All subjects received professional prophylaxis and assigned manual toothbrush and dentifrice. Group was assigned 3 weeks or more after professional prophylaxis.
717499|NCT02882854||
717500|NCT02882711||Four participants who were enrolled met exclusion criteria and therefore did not start the study.
717501|NCT02882633||
717502|NCT02882152||
717503|NCT02881957||
717504|NCT02881840||
717505|NCT02881775||
717506|NCT02881658||
717507|NCT02881567|Participants enrolled in the study at 11 investigative sites in Canada, Germany, Italy, and the United States from 05 April 2017 to 12 September 2018.|Participants who discontinued treatment with natalizumab due to safety concerns were enrolled to receive daclizumab 150 milligrams (mg) per 1.0 milliliter (mL).
717508|NCT02881112||
717509|NCT02881047||
717510|NCT02881008||
717511|NCT02880865|Participants were enrolled at 2 health centers in the Philippines.|Filipino children aged 9 to < 10 months were randomized in a 1:1 ratio to receive measles, mumps, and rubella vaccine (MMR) and prequalified live, attenuated SA-14-4-2 Japanese encephalitis vaccine (CD-JEV) together (Group 1) or 56 days apart (Group 2). All participants received a second dose of MMR at 12 months of age.
717512|NCT02880852|A total of 20 participants with Systemic Lupus Erythematosus (SLE) were enrolled. The study was conducted at 2 centers in China from 23-Jan-2017 to 08-Sep-2017.|A total of 25 participants were screened, of which 5 participants were screen failures. The reason for screen failures were: did not meet inclusion/exclusion criteria (4 participants) and investigator discretion (1 participant).
717513|NCT02880761||
717514|NCT02880514|A total of 50 participants were recruited across 12 clinical sites.|An intra-patient control design was employed where left and right frontal sinuses of each patient were randomized to the treatment or control group after successful completion of in-office balloon dilation.
717515|NCT02880475||
717516|NCT02880254||difficulty recruiting participants to be in the trial in the time frame; some agreed but then never came in to consent; there were no patients who consented but did not participate
717517|NCT02880228||
717518|NCT02880189||
717519|NCT02880137||
717520|NCT02879812||
717521|NCT02879747|All children in the fix dose group and children in the individualized dose group who have reached their midparental height SDS (>- 0.6 SDS) during at least two years of GH-treatment within the 'GH-dose-catch up' study (TR 98-0198-003) and still are prepubertal were eligible in the study.|If glucose levels at the day of inclusion were higher than 7.1 mmol/L, then the child was excluded before assignment.
717522|NCT02879032|Patient presented with stable chest pain who have undergone ETT according to Bruce protocol were selected as case considering inclusion and exclusion criteria.Cases other than stable chest pain were excluded. Informed written consent was taken from the patient. CAG report was collected from the Cath lab after the procedure.|
717523|NCT02878590||23 subjects were enrolled (i.e. given a subject number). 6 subjects did not meet the inclusion / exclusion criteria. 5 subjects did not qualify to use the Bongo device at home.
717524|NCT02878486||
717525|NCT02878382|All twenty patients completed the 12 -month study. Patients were male, Fitzpatrick skin types I-III and mean age 73.8 years (range 54-89).|
717526|NCT02878330|The study was conducted from 03-Nov-2016 to 06-Dec-2018.|A total of 1540 participants were screened, out of which 1453 participants were randomized in the study.
717527|NCT02878213|"For DURABLE-1 22 consecutive paroxysmal atrial fibrillation patients were recruited.
~The trial was extended (DURABLE-1.1) and altogether 39 paroxysmal atrial fibrillation patients were recruited."|
717528|NCT02877927||
717529|NCT02877732||
717530|NCT02877680|Recruited from diabetes clinics at Texas Children's Hospital.|Of 84 families consented, 2 families did not complete baseline questionnaires and were not randomized (1 withdrew due to time demands, 1 moved to another care institution). Of the remaining 82 families, 2 completed baseline questionnaires but were never randomized because they never completed a study visit, resulting in a randomized sample of n=80.
717531|NCT02877485||
717532|NCT02877095||
717533|NCT02877082|Patients were recruited from 9/9/2016 to 7/11/2017 at Winship Cancer Institute of Emory University.|
717534|NCT02877004|Participants recruited from the local community of Rochester, MN, 09/16-08/17. All interested individuals called a central number and underwent a 10-minute phone pre-screen. If they passed the telephone pre-screen, they were invited to attend an in-person consent visit. All study visits and treatments took place in Mayo Clinic - Rochester Campus.|After consent, patients were screened for study entry criteria. Only those who passed all criteria were invited to be randomized to study.
717535|NCT02876926||
717536|NCT02876900||
717537|NCT02876887||
717538|NCT02876757||
717539|NCT02876601|"This was a crossover study. Of 20 healthy volunteers 16 were randomly assigned to receive LPS, while 4 received Placebo only. All participants underwent two study periods: A defibrotide and a placebo period.
~The system will not let us enter this study design of a crossover study. Only 20 healthy volunteers participated."|
717540|NCT02876575|A total of 48 Adults, greater than or equal to 22 in the US and greater than or equal to 18 in Europe, were enrolled into a single-arm trial. A total of 50 subjects were screened and consented and 2 subjects were withdrawn due to physician request.|
717541|NCT02876159|Participants for this study were enrolled from 07/01/2016 to 09/30/2016. Clinical study was conducted at Hope Clinic of Emory University.|
717542|NCT02876055||
717543|NCT02875977|Patients were recruited from August 2016 through March 2017 (7 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.|
717544|NCT02875834|This study was conducted in 42 centers within Japan, Russia, South Korea, and Taiwan.|the study consisted of two phases: an open-label phase (single arm, 48 hours, ZS 10 g TID; OLP) and a randomized treatment phase (3 arms, 28 days; RTP). 267 patients entered OLP. Out of these, 248 endered RTP and were randomized to placebo, ZS 5 g QD or ZS 10 g QD in a 1:2:2 ratio.
717545|NCT02875613||
717546|NCT02875366||
717551|NCT02874846||Subjects who agreed to participate in this study were assessed during a screening visit and those who were already using ocular hypotensive medication had to undergo a washout for a specified period (5 days to 4 weeks, depending on the medication) prior to the Qualification visit.
717552|NCT02874794|Of 892 patients screened for the study, 465 completed screening and were enrolled. Of the 465 randomized, 1 patient was randomized in error to the sacubitril/valsartan group and was not treated. The Full Analysis Set and Safety Set are based on 464 patients who received treatment.|
717553|NCT02874742|223 participants were enrolled/randomized (16 in safety run-in,104 to D-RVd and 103 to RVd group). At clinical cut-off, among 207 (D-RVd [104]+RVd [103]) randomized, 201 received treatment (D-RVd: 100 and RVd: 101). 1 participant randomized to D-RVd group received RVd treatment and was randomized twice (resulting a total of 224 participants).|Participant was screen-failure and was randomized to D-RVd first; after re-screening was randomized to RVd group.The participant was counted in D-RVd for ITT analysis and RVd for safety analysis. So, safety analysis set included 99 participants in D-RVd and 102 in RVd group who received at least 1 dose of study treatment.
717554|NCT02874534||
717555|NCT02874404|Subjects were statified to Arms A, B, or C for correlative sample collection purposes only. Clinical study outcomes are not viewed differently among the groups, so subjects are presented as one arm/group.|
717556|NCT02874066|64 patients screened, 18 patients excluded|
717557|NCT02873923||
717558|NCT02873754||
717559|NCT02873702|Participants took part in the study at 8 investigative sites in China from 21 December 2016 to 06 November 2017.|Participants with erosive esophagitis (EE) were enrolled to receive: lansoprazole 30 milligram (mg) or dexlansoprazole 60 mg in Healing Period and dexlansoprazole 30 mg or Placebo in Maintenance Period. Study was terminated since compound was not expected to provide sufficient additional benefit to participants over currently available therapies.
717560|NCT02873689|Participants took part in the study at 20 investigative sites in China from 27 December 2016 to 19 April 2018.|Participants with diagnosis of symptomatic nonerosive gastroesophageal reflux disease (GERD) were enrolled in 1 of the 2 treatment groups: to receive dexlansoprazole 30 mg or placebo.
717561|NCT02873585||
717562|NCT02873481||
717563|NCT02873429|Over a 1 year period, 218 persons beginning treatment for chronic pain at conventional medicine clinics (pain clinics, physical therapy, primary care) (n=105), and integrative medicine centers (n=113) were invited to complete online assessments at 3 time-points: Baseline, 2 month, and 4 month follow-up.|9 participants enrolled (completed consent) and did not continue in the study: 2 Integrative / Complementary Alternative Medicine (CAM) and 1 Conventional withdrew after signing consent form; 2 CAM and 4 Conventional did not meet eligibility criteria after signing consent form.
717564|NCT02873377||
717565|NCT02873286||
717566|NCT02873221||
717567|NCT02873195||
717568|NCT02873104||
717569|NCT02872935||
717570|NCT02872909||
717571|NCT02872311||
717572|NCT02872285|Participants were enrolled at 7 study centers within the United States. Study centers were dermatology medical clinics experienced in conducting clinical trials.|Participants were 18 to 75 years of age with chronic plaque-type psoriasis for ≥ 6 months prior to screening. Eligible patients had a baseline Psoriasis Area and Severity Index (PASI) score > 7 with body surface area (BSA) involvement of 5-15% and overall lesion severity rated as moderate or marked.
717573|NCT02872103||
717574|NCT02872012|23 participants were recruited. Each participant received 1 cryoanesthesia intervention in one eye and one standard of care lidocaine intervention in their other eye.|
717575|NCT02871739||
717576|NCT02871635|This was an exploratory, randomized, 56-week, double-blind, parallel arm, multiple dose, active comparator trial of BI 695501 and EU-approved Humira, with a 48-week treatment period and a 10-week follow-up period (starting after last dose of trial medication at Week 46) in patients with moderately to severely active Crohn's Disease (CD)|The trial consisted of a screening period of up to a maximum of 28 days, a 48-week treatment period consisting of an induction period from baseline to Week 4 and a maintenance period from Week 5 to Week 48, and a 10-week safety follow-up period (starting after last dose of trial medication at Week 46).
717577|NCT02871570||
717578|NCT02871479||
717579|NCT02871440||
717580|NCT02871375|Subjects were recruited from 11 study centers located in the United States.|Of the 170 enrolled, 2 subjects were exited as screen failures prior to randomization. An additional 2 subjects were randomized in error but not exposed. This reporting group includes all randomized and exposed subjects (166).
717581|NCT02871128||
717582|NCT02871011||
717583|NCT02870933||
717584|NCT02870283|Response to treatment was assessed for the entire algorithm. There were no comparisons between the steps of each arm of the study|
717585|NCT02870205||
717586|NCT02870101||
717587|NCT02869893||
717588|NCT02869451|Study recruitment occurred between August 2016 to May 2017. Participants were recruited from community settings and Craigslist.|Seven participants signed consent. Two of these participants were withdrawn by the principal investigator after signing consent because they did not meet study eligibility criteria.
717589|NCT02869438||233 participants were randomized to receive treatment in study D3250C00038 (Solana) with benralizumab 30 mg or placebo. Of the 233 patients randomised, all (100.0%) received treatment with study drug. 118 (50.6%) patients received benralizumab 30 mg and 115 (49.4%) patients received placebo.
717590|NCT02868892||
717591|NCT02868554||
717592|NCT02868281|Participants were enrolled from 12 centers in China.|Total 583 participants were screened and 530 participants were enrolled into the study (53 participants were screen failures).
717593|NCT02868242|Participants were enrolled at one study site in Egypt. The first participant was screened on 28 August 2016. The last study visit occurred on 03 February 2019.|24 participants were screened.
717632|NCT02862106|Participants completed the first stage(0-76weeks),enrolled at 9 sites in the China. The first participant was screened on 19 November 2011.|209 participants entered the second stage of the study , and comprise the Safety Analysis Set and the Full Analysis Set
719757|NCT02612077||
717594|NCT02868216|dates of the recruitment: 09/15/2015 to 07/15/2017 patients with AMY in this period: 707|Patients submitted to myocardial revascularization surgery, with acute or chronic infections, need for mechanical ventilation or other complications were excluded; those with delirium, cognitive or mental difficulties, aged ≥ 80 years; and also, unable to comply with follow-up visits or who refused to participate.
717595|NCT02867995||
717596|NCT02867709||
717597|NCT02867605||
717598|NCT02867202|"all patients were recruited from 1st affiliated hospital of Wenzhou Medical University.
~Inclusion criteria were as follows:1) women aged 18 to 45 years. 2) agreed to have second-look hysteroscopy. 3) moderate to severe intrauterine adhesion (AFS score ≥5)"|"not meeting inclusion criteria
~declined to participate"
717599|NCT02867163||
717600|NCT02867150||
717601|NCT02867059||
717602|NCT02866942||
717603|NCT02866695||
717604|NCT02866643||
717605|NCT02866175|A total of 1506 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study; 1486 participants received treatment. A total of 20 participants (5 Edoxaban and 15 Vitamin K Antagonist) did not receive treatment.|
717606|NCT02865915|The study was conducted at 30 US sites. The study was initiated on 27 July 2016 and completed on 04 August 2017. Study sites consisted of a combination of private clinical research centers, medical clinics, and academic practices.|Prior to randomization, subjects completed a screening period with a wash-out of medications for PCOS symptoms (if needed). Eligible subjects then completed an 8-week Lead-in Period with an initial 5-day progestin challenge, self-report of menstrual bleeding, and assessment of ovulation status by urine pregnenediol-3-glucuronide.
717607|NCT02865720|The study was conducted in 9 study centers in Japan between 13 Sep 2016 (First participant first visit) and 23 June 2017 (Last participant last visit).|A total of 8 participants were screened and enrolled. Investigational product administrations were planned according to participants' age; 500 units (U) for participants 2 to 5 years and 1000 U for participants 6 years and older. However, as no participants under the age of 6 years were enrolled, only the higher dose of 1000 U was administered.
717608|NCT02865590||
717609|NCT02865499||
717610|NCT02865395||
717611|NCT02865343||
717612|NCT02865083||
717613|NCT02864732||
717614|NCT02864706|"In total, 95 patients (48 everolimus, 47 controls), attended the follow-up visit at 5-7 years post-transplant and were included in the safety population
~The PP population (27 everolimus, 35 controls) excluded 7 patients in the everolimus group and 11 in the control group who discontinued study drug prematurely"|Two patients randomized to everolimus did not provide a month 12 measured GFR (mGFR) value and were excluded from the ITT population, which thus comprised 93 patients (46 everolimus, 47 controls).
717615|NCT02864394|Participants with non-small cell lung cancer (NSCLC) and programmed cell death ligand 1 (PD-L1) positive (Tumor Proportion Score [TPS] ≥1%) tumors who had experienced disease progression after platinum-containing systemic therapy were recruited.|Of 425 participants randomized, 411 received treatment on study. All 425 participants were PD-L1 positive (TPS ≥1%). At the time of the Final Analysis data cut-off (09-Sep-2019), 130 participants were ongoing in the study.
717616|NCT02864381|Participants were enrolled at study sites in Australia, Europe, and the United States. The first participant was screened on 01 September 2016. The last study visit occurred on 23 August 2019.|187 participants were screened.
717617|NCT02864342|Subjects with chronic obstructive pulmonary disease (COPD) were recruited into 8 study sites in the United States from August 2016 to October 2017. The study evaluated the impact of medication reminders on adherence to Symbicort pressurized metered dose inhaler (pMDI) using a BreatheMate bluetooth device that monitored daily Symbicort inhaler use.|Subjects who entered the study already on a stable dose of Symbicort were enrolled and randomized at Visit 1 followed by a 26-week treatment period. Subjects who converted to Symbicort were enrolled at Visit 1 and entered a 25-day run-in period after which they were randomized at Visit 2, followed by a 26-week treatment period.
717618|NCT02864316||2 subjects were screen failures
717619|NCT02864069||
717620|NCT02863575||
717621|NCT02863419|The trial was conducted at 101 sites in 12 countries as follows:Croatia (5), Czech Republic (3), Germany (8), Hungary (9), Japan (9), Latvia (4), Poland (9), Slovakia (5), South Africa (5), Ukraine (3), United Arab Emirates (2), United States (39).|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
717622|NCT02863328|The trial was conducted at 108 sites in 12 countries as follows: Argentina (4), Brazil (3), Croatia (4), Greece (7), Hungary (7), Italy (5), Poland (6), Russian Federation (6), Serbia (5), Spain (8), Thailand (3), United States (46). 1 site each in Croatia and Italy, and 2 sites in the United States screened, but didn't randomise any subjects.|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
717623|NCT02863289|From 01/11/2016 to 01/03/2017 in Tayside.|All children who sustained proximal humerus fracture at age of 10 to 18 years old in Tayside.
717624|NCT02863263||
717625|NCT02863198||
717626|NCT02862912||
717627|NCT02862730||
717628|NCT02862600|Fifty subjects were screened at 13 US centers. Of these, 36 were found suitable for enrollment, and 35 were enrolled prior to study termination.|The principal reason for screen failure was attainment of > 75% of the maximum predicted MVO2 on CPEX testing. One subject was found to be a CYP2D6 poor metabolizer.
717629|NCT02862574|Participants were enrolled at study sites in the United States. The first participant was screened on 15 December 2016. The last study visit occurred on 07 August 2017.|28 participants were screened.
717630|NCT02862548|Participants were enrolled at a study site in New Zealand. The first participant was screened on 16 September 2016. The last Week 48 study visit occurred on 26 July 2018.|57 participants were screened.
717631|NCT02862535|Participants were enrolled at study sites in Japan. The first participant was screened on 20 Sep 2016. The last study visit occurred on 25 Oct 2019.|39 participants were screened.
717633|NCT02861937|Thirty four patients (19 males and 15 females, aged 20-60 years) were consecutively enrolled over a six month period (April 2014 to September 2014) from the outpatient department of periodontology, Krishnadevaraya College of Dental Sciences, Bangalore, and Karnataka.|12 chronic gingivitis, 12 chronic periodontitis patients and 10 healthy individuals were included as control. Patients systemically healthy having more than or equal to 14 functional teeth, patients had not received any form of surgical/non surgical periodontal therapy or received antibiotics within the past 6 months.
717634|NCT02861807||
717635|NCT02861664|All participants were recruited at a single center in China.|A total of 273 participants were screened, out of which 135 participants were randomized to the study. 138 participants were not randomized because out of these, 135 participants did not meet the study criteria and 3 participants withdrew consent.
717636|NCT02861534||
717637|NCT02861131||
717638|NCT02861118|Participants took part in the study at the 25 investigative sites in Spain from 26 October 2016 to 04 April 2018.|Participants with a diagnosis of ulcerative colitis (UC) or Crohn's disease (CD) who started treatment with biologics between June 2011 and June 2013, participated in the study. Total 357 participants were registered, out of which only 310 participants were analyzed.
717639|NCT02860845||
717640|NCT02860507||
717641|NCT02860169|Participants were recruited from one center at United Kingdom (UK).|This study was divided in 3 parts (A, B and C). Part A was an online survey, Parts B and C. Participants recruited separately for each part of the study based on the inclusion and exclusion criteria of respective part of the study. (46 [part A] + 20 [part B] + 48 [part C] = 114 enrolled in the study)
717642|NCT02859597||
717643|NCT02859454||
717644|NCT02859441||
717645|NCT02859246||
717646|NCT02858726||Of 226 enrolled participants, 175 met inclusion criteria and were randomized to treatment.
717647|NCT02858713||
717648|NCT02858492|The study evaluated safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of GSK2982772 in participants with rheumatoid arthritis (RA). Participants were randomly assigned to receive either GSK2982772 60 milligram (mg) or placebo to be taken orally twice daily (BID) or three times daily (TID) for 84 days.|A total of 99 participants were screened, of them, 47 participants were screen failures and 52 participants were enrolled. Of them, 51 participants received study treatment. One participant was enrolled in the study but never received study treatment as eligibility criteria for dose was not met.
717649|NCT02858440||
717650|NCT02858401|Participants were enrolled at study sites in United States. The first participant was screened on 29 January 2015. The last study visit occurred on 14 February 2019.|58 participants were screened.
717651|NCT02858362|Participants were enrolled in 16 sites across the United Kingdom (UK) and United States (US) between the dates of 16 June 2016 (First Patient In) and 11 September 2018 (Last Patient Out). Cohort 1 was conducted in the UK and US, Cohort 2 was conducted in the US only, and Cohort 3 was conducted in the UK only.|
717652|NCT02858349||
717653|NCT02858180|Between 12/2016 and 12/2018, 15 subjects with chronic HCV and advanced heart failure or chronic HCV and lung disease were enrolled across 4 sites (academic medical centers in the US). Subjects all have genotype 1, 4, 5 or 6 HCV.|
717654|NCT02858050||
717655|NCT02857816|One hundred fifty-four subjects were enrolled (consented) to participate in the trial from September 15, 2016 through August 14, 2017 from 12 US centers.|Out of 154 enrolled subjects, 120 were qualified and 121 subjects received PTNM therapy, with 1 not meeting eligibility criteria.
717656|NCT02857426||"47 PCNSL participants were randomized (enrolled) and treated.
~19 PTL participants were randomized (enrolled) and treated."
717657|NCT02857283|A total of 17 participants were screened between April 22, 2017 and May 1, 2019. Participants were recruited from a database of subjects at the Center for Environmental Medicine, Asthma and Lung Biology.|Two participants did not meet inclusion criteria, and 1 withdrew before undergoing the second exposure. All participants were free from acute illness
717658|NCT02856880||A total of 150 participants were screened, of which 45 participants were randomized and 44 completed the study.
717659|NCT02856828||
717660|NCT02856555|Participants were enrolled at study sites in United States. The first participant was screened on 08 August 2016. The last study visit occurred on 18 July 2017.|433 participants were screened.
717661|NCT02856282|This study was conducted in United Kingdom. Participants who purchased product took part in online survey conducted by either of 2 methods: 1- scanned a Quick Response code on product package labelling/link on the product box, 2- via an e-mail invitation (who purchased product at a Boots Pharmacy), that included a link to the survey.|A total of 72 participants were screened out of whom only 46 answered the survey. Rest 31 were screen failures.
717662|NCT02856035||
717663|NCT02855567||
717664|NCT02855541||
717665|NCT02855450||
717666|NCT02855437|The target population recruited was patients with gout. Patients were recruited from the UAB gout clinic, The Kirklin Clinic, and the UNMC gout clinic.|
717667|NCT02855411|A total of 35 participants were screened before study termination.|No participants had been randomized to receive study drug or placebo before study termination.
717668|NCT02855359||
717669|NCT02855086||
717670|NCT02854800|Participants were recruited from the Comprehensive Outpatient Addiction Treatment (COAT) program at Chestnut Ridge Hospital on the campus of West Virginia University. Participants were recruited from the COAT clinic between 7/8/2016 and 2/2/2017.|All participants that were enrolled (after passing the initial screening and not meeting any of the exclusion criteria) were assigned a group.
717671|NCT02854631|Participants were enrolled at study sites in Europe and North America. The first participant was screened on 01 September 2016. The last study visit occurred on 31 May 2018.|166 participants were screened.
717672|NCT02854605|Participants were enrolled at study sites in North America, Hong Kong, New Zealand, and Europe. The first participant was screened on 26 October 2016. The last study visit occurred on 09 January 2018.|327 participants were screened.
717673|NCT02854540||
719758|NCT02612064|Participants were recruited at the clinical site in United Kingdom (UK).|In total, 488 participants were screened, out of which 230 participants were randomized.
717674|NCT02854527||This is an open-label, randomised, single-dose, five-way, ten-sequence crossover study. Four drugs (Digoxin (R1), Furosemide, (R2), Metformin hydrochloride (R3), Rosuvastatin (R4)) were given as monotherapy and one as a combination of all four drugs together as test cocktail (T) in pre-defined sequences.
717675|NCT02854059||
717676|NCT02853929|Subjects enrolled in the study were infants aged 9 months at the time of enrollment, born to mothers vaccinated with Boostrix in study 116945 BOOSTRIX-047 [NCT02377349] and who received primary vaccination Infanrix hexa co-administered with Prevenar 13 in study 201330 BOOSTRIX-048 [NCT0242264]|"551 subjects were enrolled in this trial, out of which 540 received the booster dose of Infanrix hexa co-administered with Prevenar 13.
~11 subjects did not receive booster vaccination even though subject number had been allocated."
717677|NCT02853435|This study was conducted across 2 centers in the United States from 04-August-2016 to 18-October-2017. Since the relative bio-availability of the roller compacted(RC) tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|A total of 48 participants were enrolled in the study of which 26 participants were randomized in Part 1a, 10 participants were randomized in Part 2 and 12 participants were part of Placebo-controlled Part 3.
717678|NCT02853331||These interim results are based on a database cutoff date of 24-Aug-2018, at which time 693 participants were ongoing in the study.
717679|NCT02853318||
717680|NCT02853123|This was a randomised, double-blind, active-controlled, 2-period crossover, Phase IV study to evaluate the effects of once daily administration of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on the intensity of breathlessness in patients with Chronic Obstructive Pulmonary Disease (COPD).|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which then ensured that all patients met all inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any specific entry criteria were violated.
717681|NCT02853032||
717682|NCT02852434||
717683|NCT02852265|We consented and enrolled 20 women in the outpatient clinic at the University of California, Davis Department of Obstetrics and Gynecology for study participation between September and December 2016.|
717684|NCT02851823||Split-mouth design (test and control in the same patient).
717685|NCT02851108||
717686|NCT02851069||A total of 66 participants were enrolled in the study; 1 participant never started treatment and thus the safety population was comprised of 65 participants. In this study, the safety population, target population, and core population were identical.
717687|NCT02850978|This was an observational study based on newly collected data under real-world practice in participants diagnosed with chronic obstructive pulmonary disease (COPD) (chronic bronchitis, emphysema) in Japan.|This non-randomized, post marketing surveillance (PMS) was a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline, concomitant drug in use) were defined for participant enrollment. Participants were enrolled from August 2016 to August 2017.
717688|NCT02850965|This was a Phase III, multinational, randomized, double-blind, parallel-arm, multiple-dose, active-comparator trial of BI 695501 and US-licensed Humira with a 24-week treatment period and 10 weeks of safety follow up, in patients with moderate to severe chronic plaque psoriasis.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
717689|NCT02850276|Enrollment period from November 2015 to Jan 2018|
717690|NCT02850159||
717691|NCT02850068||
717692|NCT02849990||
717693|NCT02849938||
717694|NCT02849704|Subjects were recruited from academic medical centers in the Philadelphia region between August 2016 and November 2017. For the CP cohort, subjects were diagnosed with CP by a gastroenterologist based on criteria as recommended by the American Pancreatic Association (APA) Practice Guidelines.|There were no events between enrollment and assignment in either group. All subjects enrolled were assigned to the appropriate arm.
717695|NCT02849678|Patients were enrolled between the period of October, 2009 and August, 2011|Three patients were consented but not randomized due to failure to meet inclusion criteria (3 screen failures)
717696|NCT02849626|Participants took part at 58 investigative sites in the United States, European Union and Asia Pacific. A total of 208 participants were screened and enrolled, of which 28 were screen failures and 180 received study treatment in Core Phase. Of 146 participants who completed the Core Phase, 136 entered Extension Phase A and received study treatment.|This study included a Core Phase and two Extension Phases (Extension Phase A and Extension Phase B). This result summary includes data only for the Core Phase and Extension Phase A of the study at the primary completion date (05 February 2019). Extension Phase B results will be provided at the time of study completion date.
717697|NCT02849509||
717698|NCT02849418|This study evaluated the efficacy and safety of GSK1358820 (botulinum toxin type A) in participants with urinary incontinence due to neurogenic detrusor overactivity. This was a multicenter study conducted at 7 centers in Japan.|A total of 30 participants were screened of which 21 participants were randomized (11 participants in the GSK1358820 200 Unit [U] group and 10 participants in the placebo group).
717699|NCT02849184||
717700|NCT02849080|The main phase of the trial was conducted at 77 sites in 10 countries, and the extension phase (Switch) at 71 sites in 9 countries, as follows (main phase/extension phase): Argentina (3/3), Austria (3/3), Belgium (7/7), Brazil (2/0), Egypt (4/4), Norway (4/4), South Korea (7/7), Switzerland (8/5), Turkey (8/8), and United States (31/30).|The trial consisted of two treatment periods: a 52-week main phase and a 52-week extension phase. In Switch, participants were allowed to re-randomise from sitagliptin to oral semaglutide. Sustainability included results for participants who received oral semaglutide during main + extension phase.
717701|NCT02848729||
717755|NCT02839902|Participants took part in the study at 7 investigative sites in Japan, from 27 December 2016 to 30 August 2017.|Participants with a historical diagnosis of hyperlipidemia who were inadequately controlled while receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor were enrolled in one of two groups, treatment group with omega-3-acid ethyl esters (TAK-085) 2 grams (g) and treatment group without TAK-085 (Control Group).
725556|NCT02110238|29 outpatient medical clinics enrolled subjects over 4.5 months|
717702|NCT02848664|Potential patient participants were recruited from patients who had previously participated in protocol on The Passy Muir Swallowing Self Training Device, Voice and Swallowing Clinics, community hospitals, announcements in websites of patient support groups, and contacts with speech language pathologists specializing in dysphagia.|Exclusion of those with psychiatric, epilepsy, severe speech/language communication disorders, cognitive impairment, esophageal disorders, and inability to tolerate a nasal endoscopic examination. Inclusion criteria: 13 years or older, parental consent if under 18, stable medical condition and oropharyngeal dysphagia.
717703|NCT02848651||
717704|NCT02848599|From July 2016 to September 2017, 86 patients were included in the study in accordance with the inclusion criteria and 70 of them completed the study. The study design was a prospective, randomized, controlled trial. It was conducted at the University Hospital Osijek (Croatia).|No patients were excluded from the study before assignment to groups.
717705|NCT02848326||Participants diagnosed with migraine, with or without aura were enrolled in one of 6 treatment arms: placebo, or atogepant 10 mg once daily (QD), 30 mg QD, 60 mg QD, 30 mg twice daily (BID), or 60 mg BID.
717706|NCT02848313||
717707|NCT02848222||
717708|NCT02847858|Individuals were recruited from 18 participating school-based health centers in the Los Angeles UnifiedSchool District starting August 2016 and ending May 31, 2018. Clinic staff provided all female youth who entered the clinic an opportunity to use the iPad with the intervention app (baseline questionnaire for the control group).|
717709|NCT02847650||
717710|NCT02847637||A total of 161 participants were screened, of which 9 failed screening and 152 who previously received either episodic or prophylactic treatment with FVIII agents were enrolled in this study. Participants in Arms A, B, and C were randomized in a 2:2:1 ratio; participants in Arm D were enrolled without randomization.
717711|NCT02847494||
717712|NCT02847260||
717713|NCT02847182||
717714|NCT02847169||
717715|NCT02846792|Seattle Cancer Care Alliance/University of Washington Phase I/II trial open label study enrolled patients at a single site between June 2017 and July 2018.|Five patients were consented and treated.
717716|NCT02846779||
717717|NCT02846740||
717718|NCT02846714||
717719|NCT02846558||
717720|NCT02846415||
717721|NCT02846324||
717722|NCT02846233||
717723|NCT02845752||
717724|NCT02845700|Participants were recruited from the community. Assessments occurred at the Florida State University Anxiety and Behavioral Health Clinic. In total, 16 individuals were assessed for eligibility. Of these, 15 participants were randomized to an intervention condition, and 1 was excluded because they were not combat exposed.|Of the 15 participants randomized to condition, 2 did not receive their allocated intervention (both in the Sensory Retraining Treatment [i.e., active] condition), because they withdrew from the study before the baseline appointment.
717725|NCT02845674||Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002.
717726|NCT02845375|46 subjects were enrolled.6 did not meet inclusion citeria. 40 subjects were randomized|
717727|NCT02845336||
717728|NCT02844998||
717729|NCT02844946||
717730|NCT02844920||
717731|NCT02844569||
717732|NCT02844543||
717733|NCT02843659||45 subjects enrolled, 18 subjects were randomized/treated. 15 subjects didn't complete the treatment period. The study was terminated and the remaining 15 randomized subjects who had not yet completed the double-blind period entered the follow-up period. Of the 15 subjects who entered the follow-up period, 12 did not complete the follow-up period
717734|NCT02843529||
717735|NCT02843178||
717736|NCT02842866|Study was conducted from 15-July-2016 to 13-February-2017 at 35 sites in the United States and Puerto Rico.|Total 907 participants were enrolled in the study, out of which 906 were randomized. 1 participant was not randomized to either of the 2 treatment groups; this participant was not vaccinated and did not provide blood samples, therefore not counted in any analysis.
717737|NCT02842853|Study participants were enrolled in 90 centers in the United States (US) from 15 July 2016 to 16 August 2016.|A total of 3344 participants who met all inclusion and none of the exclusion criteria were enrolled and randomized in the study.
717738|NCT02842736||
717739|NCT02842242||
717740|NCT02842151|Subjects were recruited from 3 investigative sites located in Ireland (1) and the US (2).|Of the 162 enrolled, 12 subjects were exited as screen failures prior to intraocular lens (IOL) implantation. This reporting group includes all subjects with attempted implantation (150).
717741|NCT02842086|Participants were enrolled at study sites in the United States, Canada, and the European Union. The first participant was screened on 02 September 2016. The data cut date for the end of blinded treatment phase was 12 December 2019.|5857 participants were screened.
717742|NCT02842073||
717743|NCT02842060||
717744|NCT02841787||
717745|NCT02841709|Conducted at 10 centers in 2 countries (USA and Germany)|Screening phase: From informed consent to randomization, lasting a max. of 28 days and comprising a screening period (screening visit + at least 7 days at home) and a run-in period (2 consecutive PSG nights on SB placebo, + 5-12 days at home with no treatment). Note: More subjects were randomized (n = 58) than originally planned (n = 50).
717746|NCT02841449||n = 17 recruited; n = 1 withdrew prior to starting the study due to surgery (unrelated to study)
717747|NCT02841267||One participant in Cohort 2 was consented, but elected to withdraw from the study prior to assignment to a treatment arm.
717748|NCT02841241||
717749|NCT02841189||
717750|NCT02841046||
717751|NCT02840916||
717752|NCT02840721||
717753|NCT02840461||
717754|NCT02840253||
718422|NCT02750410||After 16 weeks of the primary double-blind treatment period, participants taking placebo were switched to dulaglutide for an additional 36 weeks of open-label extension treatment. Efficacy was assessed for 16 weeks based on hypoglycemic agent evaluation.
717756|NCT02839889|This multi center was conducted at 3 sites in the US. Enrollment to the study was stopped due to recruitment challenges and no new patients have been screened as of January 2018. 5 patients were randomized across the 2 treatment groups.|To confirm eligibility participants underwent a 7 day baseline assessment/OIC confirmation period. 12 patients provided consent for this study, however 7 did not fulfill eligibility criteria during the 7 day baseline period.
717757|NCT02839876||
717758|NCT02839798||
717759|NCT02839772||
717760|NCT02839746|"The data collection periods:
~When planned to be switched from vitamin K antagonists (VKA) to Pradaxa® (At baseline, Visit 1)
~7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2)
~125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)
~Questionnaire (quest.)"|All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met.
717761|NCT02839681||Per protocol: Phase 2 Cohort was not performed because we did not accrue at least 6 subjects in the Safety run-in cohort. The first 6 evaluable subjects enrolled in whom the higher of 2 de-escalating doses of anetumab ravtansine will be evaluated in order to determine the recommended Phase 2 dose.
717762|NCT02839330|This study was conducted at 26 centers in the USA.|All enrolled subjects were included in the study. A total of 5 subjects were enrolled and randomized in error by sites. These subjects were deemed screen or randomization failures due to violation of the inclusion and/or exclusion criteria. Therefore, of the 3196 subjects enrolled in the study 3191 subjects were vaccinated.
717763|NCT02839200|Conducted at 38 sites in 6 countries (Germany, Hungary, Israel, Spain, Sweden, and the USA)|"Screening details: screening period (screening visit followed by at least 7 days at home) and a run-in period (2 PSG nights on single-blind placebo, followed by 5-12 days with no treatment), and lasting a max. of 28 days. N = 360 subjects were randomized; N = 359 subjects were treated; N = 1 subject discontinued due to randomization error."
717764|NCT02838901|The study enrolled adults who have suffered an ischemic stroke with minimum impairments defined by NIHSS scores and physical function measurements.|From June 2012 to June 2016, patients who are admitted to the Stroke Unit and who are within 96 hours of symptom onset, were screened for eligibility by reviewing their admitting history and physicals and imaging results.
717765|NCT02838420|Asian adult participants with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) were enrolled at 21 study sites in 3 countries - China, Korea, and Thailand.|
717766|NCT02838407||
717767|NCT02838134||26 patients were assessed for eligibility but excluded, 8 patients did not meet the inclusion criteria 18 patients declined to participate
717768|NCT02838017||
717769|NCT02837952||
717770|NCT02837913||
717771|NCT02837731||
717772|NCT02837328|Participants of 55 years of age or older were recruited using fliers, the University of Minnesota StudyFinder website, invitations to individuals enrolled in the ResearchMatch research volunteer database, and invitations to University of Minnesota School of Public Health employees.|Participants attended a baseline visit where measurements were conducted and a Zio XT Patch heart rhythm monitor was applied by trained staff. After wearing the patch for 2 weeks, the participants were randomized 1:1 to either magnesium oxide or a placebo using block randomization within two strata of age (younger than 65 and 65 and older).
717773|NCT02837237||
717774|NCT02837029|The study opened for accrual on July 25th, 2016 with goal of 40 patients. The first patient started treatment Sep. 12, 2016. The study design for Phase 1 was 3 + 3 dose escalation. Accrual was suspended on June 7, 2019 for review of DLT data for dose Level 2 of Phase 1. The study closed Jun. 2, 2020 due to funding issues and Phase 1b never opened.|
717775|NCT02836990|Participants were recruited from UBMD Vascular Surgery Office and were consented at the time of surgery at Buffalo General Medical Center between 2016 and 2019.|
717776|NCT02836652||
717777|NCT02836613|Open label, randomized, parallel group with study drug administration on Day 1 and up to 20 weeks blood sampling.|
717778|NCT02836496|This 32-week, randomized, double-blind, placebo-controlled study assessed the efficacy and safety of mepolizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks compared with placebo in adolescent and adult participants with severe hypereosinophilic syndrome (HES) receiving standard of care (SoC) therapy.|A total of 108 participants were enrolled in the study and randomized. The study was conducted in 13 countries.
717779|NCT02836249|Participants were enrolled at study sites in China. The first participant was screened on 25 August 2013 for the main study and the first participant screened in China was on 19 June 2015. The last Week 48 visit for the primary endpoint in China occurred on 15 December 2016.|227 participants were screened in China.
717780|NCT02836236|Participants were enrolled at study sites in China. The first participant was screened on 25 August 2013 for the main study and the first participant screened in China was on 19 June 2015. The last Week 48 visit for the primary endpoint in China occurred on 24 February 2017.|239 participants were screened in China.
717781|NCT02835820||
717782|NCT02835690||Of 44 participants enrolled, 42 received treatment. As of the 19-Sept-2017 database cut-off, 26 participants were ongoing in the study for long-term safety and survival follow-up.
717783|NCT02835677|Recruitment occurred in the Neurology Service at the Memphis Veterans Affairs Medical Center (VAMC).|
717784|NCT02835495||"Of 118 enrolled participants, 58 met inclusion criteria.
~51 participants were randomized. 1 had to withdraw pre-intervention initiation due to cancer diagnosis.
~50 participants were randomized and received the intervention treatment."
717785|NCT02835339||66 Women were consented, enrolled and assigned a study arm for this study. However, this was prior to clinical need for intervention, therefore several women who were enrolled in the study did not show clinical need for intervention.
717786|NCT02835274||
717787|NCT02835092||
717788|NCT02834819||
717789|NCT02834806||
717899|NCT02817841||A total of 2,148 participants aged 16-50 years were enrolled. Of those, 1,864 participants started the investigational product. Two hundred and eighty-four participants did not start the investigational product for the following reasons: lost to follow-up (166), withdrew consent (31), and other reasons (87).
717790|NCT02834663|This was an interventional, prospective, single-center study conducted at Wonkwang University Hospital from August 2016 to February 2019. All patients included in the study provided signed, informed consent prior to enrollment.|previous history of vitreoretinal surgery, post-cataract operation status (≤4 months before participation in this study), uncontrolled hypertension, or glaucoma were excluded from the study.
717791|NCT02834624|Infants < 35 weeks gestation requiring intubation and surfactant for Respiratory Distress Syndrome. Infants with suspected congenital infection, major birth defects, known chromosomal disorder, cord blood pH < 7.0, or Apgar score of 3 or < at 10 minutes were excluded. The infants were randomized to receive either Poractant or Calfactant.|
717792|NCT02834247|Participants took part in the study at 13 investigative sites in the United States, Spain and United Kingdom from 12 August 2016 to 30 November 2018.|Participants with advanced solid tumors and metastatic TNBC were enrolled in Parts 1 and 2 respectively. Part 2 cohorts: TNBC cohort was discontinued due to insufficient efficacy of drug. Study was terminated before start of potential fixed dose cohort, non-small cell lung cancer cohort and head and neck squamous cell carcinoma cohort.
717793|NCT02833974|This study investigated the safety, pharmacodynamics, and effect of the Toll-like receptor 7 (TLR7) agonist, GSK2245035, on allergen-induced asthmatic response in participants with mild allergic asthma. Participants received either intranasal 20 nanogram (ng) GSK2245035 or placebo once weekly for 8 weeks.|A total of 36 participants were randomized at different centers in United Kingdom and Germany..
717794|NCT02833948||
717795|NCT02833922||
717796|NCT02833857|This study was conducted at 6 centers in the United States, United Kingdom, and the European Union. Participants were enrolled from 14 March 2017 to 01 October 2018.|
717797|NCT02833844|This study was conducted at 72 centers in Australia, Belgium, Brazil, Canada, France, Greece, Italy, Poland, Portugal, Romania, South Africa, Spain, Switzerland, United Kingdom, and United States. The first participant was enrolled on 22 May 2017, and the last participant was enrolled on 23 January 2019.|"Participants were randomized in a 2:1 ratio to evolocumab or placebo, respectively, in a double-blind manner. Randomization was stratified by entry statin treatment and hepatitis C status.
~Data presented are based on a data cutoff date of 9 July 2019."
717798|NCT02833415||
717799|NCT02833350|578 participants were enrolled in the study and 578 were dosed. One (1) subject in Cohort 2 in the Placebo arm was incorrectly dosed with the High Dose. The ITT data set included participants according to their randomization while SAF data set included participants according to the treatment administered.|
717800|NCT02833337||
717801|NCT02833077|A total of 221 participants were enrolled in the study, with enrollment defined as signing the informed consent form. A total of 29 enrolled participants were screen failures (did not meet eligibility criteria). Thus, a total of 192 participants were randomized.|
717802|NCT02832674|One hundred and twenty-one subjects were screened and 72 were enrolled. study initiation 25Jun2015.|No significant events occurred during the study recruitment process.
717803|NCT02832375|Participants were recruited at one center in United States.|A total of 266 participants were screened, out of which 242 participants were randomized. 24 participants were not randomized because 14 participants did not met the study criteria, 1 participant was lost to follow up and 9 participants withdrew consent from the study.
717804|NCT02832284||
717805|NCT02832167||239 participants were treated.
717806|NCT02832154||
717807|NCT02832115||
717808|NCT02831855||
717809|NCT02831764|This study is a Phase 3, randomized, double-blind, parallel group, non-inferiority study. A total of 104 investigational centers in 18 countries randomized one or more participants in this multicenter study. The results presented are based on the primary analysis at Week 48.|Total of 722 participants were enrolled and randomized; however only 719 participants (3 participants were never dosed following randomization as they withdrew consent to participate in study) were dosed in to the study to receive either dolutegravir plus lamivudine (DTG+3TC) or dolutegravir plus tenofovir/emtricitabine (DTG+TDF/FTC).
717810|NCT02831673|This study is a randomized, double-blind, parallel-group, non-inferiority study. A total of 87 investigational centers in 18 countries randomized one or more participants. The results are presented based on primary analysis at Week 48. Analysis presented used a data cut-off date of 22-May-2018 (for Week 48 database freeze).|Total of 719 participants were enrolled and randomized, however only 714 were dosed in the study and 5 were not dosed due to physician decision (3), protocol deviation (1) and participant's own decision (1).
717811|NCT02831660||
717812|NCT02831569||
717813|NCT02831387||
717814|NCT02831257||
717815|NCT02830893|Recruitment period from June 2017 to May 2018.|23 study participants were screened and all 23 study participants were randomized.
717816|NCT02830880|Study participants were recruited from patients receiving services at Emory University Hospital in Atlanta, Georgia. Participant enrollment began in July 2016, follow up for the primary outcome measures was complete by December 1, 2018 and follow up for the secondary outcome measure was completed on September 30, 2019.|
717817|NCT02830438|Outpatient|
717818|NCT02830087||
717819|NCT02829996||
717820|NCT02829983||
717821|NCT02829944|This study recruited participants from the Duke Labor and Delivery population, as they presented for scheduled Cesarean Delivery.|
717822|NCT02829918|Participants were recruited at Moffitt Cancer Center, City of Hope Cancer Center and Winship Cancer Center October 2016 through January 2019.|
717823|NCT02829775|A total of 9 participants were recruited in the study: 8 participants from study NO16006 (NCT02736721) and 1 participant from study NO16007 (NCT number not available).|
717824|NCT02829463||
717825|NCT02829320|This was a 24-week, Phase 3, open-label, non-comparative, multicenter study to evaluate the efficacy and safety of GSK1278863 in Japanese hemodialysis participants with renal anemia not using Erythropoiesis Stimulating Agents. The study was conducted at 18 centers in Japan from 08-Aug-2016 to 17-Oct-2017.|A total of 36 participants were screened and 8 failed screening because of not meeting eligibility criteria (7) and withdrawal by participants (1). The remaining 28 participants were enrolled in this study. This study consisted of a 4-week screening period, a 24-week treatment period and a 2 to 4-week follow-up period.
718423|NCT02750345||
718424|NCT02750332||
717826|NCT02829307|This study was conducted at a single center in Netherlands from 23-Aug-16 to 27-Jan-17. A total of 8 participants were randomized in the study who received 89Zr-GSK3128349 which was a mixture of unlabelled and zirconium-labelled GSK3128349, in the form of solution for intravenous (IV) administration.|A total of 34 participants were screened, of which 26 were screen failures. The reasons for screen failure were: did not meet the inclusion/exclusion criteria (11 participants) and investigator discretion (15 participants).
717827|NCT02829294|Subject were recruited from the normal clinic population and based on the investigators prior knowledge of treating subjects with the conditions.|Subjects were pre-screened. If subjects agreed to participate, treatment was scheduled. On the treatment day, subjects were re-screened to ensure inclusion/exclusion criteria were met. Subjects were consented and then proceeded to treatment.
717828|NCT02829138||
717829|NCT02829034||
717830|NCT02828982|Recruitment began after initial approval from the University of Michigan IRB (July 2016). Participants were recruited through the University of Michigan Orthotics and Prosthetics Clinic by a study physician and study prosthetist in-person, through phone or email, or with flyers.|Participants were asked to complete both arms of the study. Before starting, participants were randomly enrolled in the dynamic response foot (unpowered prosthesis) or powered condition to start with. Some participants completed both arms while others only finished one of the arms.
717831|NCT02828917||
717832|NCT02828644||
717833|NCT02828436||
717834|NCT02828241|Subjects were randomized to either DFD-04 Ointment or Placebo Ointment in a ratio of 2:1|
717835|NCT02828137||
717836|NCT02828124|There were 10 subjects were treated in this study. All 10 subjects were enrolled in BMS-986183 escalation (Part 1)|
717837|NCT02828111||
717838|NCT02828020||
717839|NCT02827708|The trial was conducted in 8 countries (107 sites screened/88 randomised subjects), as follows: Denmark: 7/4; Finland: 7/7; Israel: 7/6; Poland: 2/2; Russian Federation: 19/18; Sweden: 6/4; United Kingdom: 9/7; United States (US):50/40. In addition, 10 sites in the US were approved by the institutional review board, but didn't randomise any subject|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
717840|NCT02827500|Subjects hospitalized with acute heart failure were randomized prior to discharge from September 2016- April 2018.|
717841|NCT02826798||
717842|NCT02826694||
717843|NCT02826603|Overall, 1353 patients were screened of which 1102 patients completed the Screening phase; 251 patients were screen failures|"The randomized set was defined as all patients who were randomized at the baseline visit. Unless otherwise specified, mis-randomized patients were excluded from the randomized set.
~Mis-randomized patients were those who were screen failures, but had been randomized by the Investigator before eligibility was assessed, but had not been treated"
717844|NCT02826551||
717845|NCT02826421|Subjects were recruited from 4 study centers located in Spain and 2 study centers located in France.|"Of the 114 enrolled, 2 subjects did not meet inclusion/exclusion criteria, and 3 subjects were excluded prior to randomization for other reasons (ie, the maximum number of randomized subjects was reached). This reporting group includes all randomized subjects (109)."
717846|NCT02825992||
717847|NCT02825966||
717848|NCT02825680||
717849|NCT02825550|The recruitment started in April, 2016. The location was all taken place in National Cheng Kung University Hospital. Patients who met inclusion criteria were recruited.|
717850|NCT02825251|The trial was conducted at 92 sites in 9 countries.as follows: Belgium (7), Canada (8), France (10), Germany (9), Netherlands (9), Russian Federation (11), Slovenia (2), United Kingdom (6), and United States (30). One (1) site in the Netherlands screened, but didn't randomise any subject.|There was a 4-week run-in period primarily for reinforcement of subject training in trial procedures, diabetes education and collecting baseline assessments. Subjects remained on their pre-trial insulin treatment during the run-in period.
717851|NCT02825212|Participants were self referred after discussion with their physicians, enrolled sequentially over a two year period (2016-2018)|Long recruitment, with part of the problem of finding patients not already on antivirals. The original protocol was for Harvoni, which had been specifically licensed for Hepatitis C Virus genotype 1. Protocol was modified after discussion with Gilead with the licensing of Epclusa, which is active for other genotypes, specifically to be able to include two patients with genotype 2 thus enabling the study to reach full enrollment. Study objective is not to compare medications.
717852|NCT02825043||
717853|NCT02824913||
717854|NCT02824562||
717855|NCT02824432|Participants took part in the study at 7 investigative sites in Japan, from 04 August 2016 to 19 August 2017.|Participants with a historical diagnosis of hyperlipidemia were enrolled in one of two groups, omega-3-acid ethyl esters (TAK-085) 2 grams (g) and TAK-085 4 g treatment groups.
717856|NCT02824224||Excluded (n=5) from participation after signing informed consent form. Discontinued IUD (n=1) Declined to participate (n=2) Non-compliant with diaries (n=2)
717857|NCT02824198|Study participants were enrolled from 01 July 2016 to 18 February 2017 at 3 sites in Singapore.|A total of 118 participants who received 3 doses of CYD dengue vaccine in study CYD28 (NCT00880893) were enrolled and randomized in this study (CYD63).
717858|NCT02823964||
717859|NCT02823600||
717860|NCT02823470||
717861|NCT02823431||
717862|NCT02823080||
717863|NCT02822950||
717864|NCT02822885||
717865|NCT02822794|Participants were enrolled at study sites in Japan. The first participant was screened on 25 July 2016. The last study visit occurred on 25 August 2017.|132 participants were screened.
717866|NCT02822612||
717867|NCT02822287|Participant were recruited at 1 center in Germany|A total of 58 potential participants were screened and 57 participants were included in the study. All 57 participants received the investigational product.
718425|NCT02750306||
718426|NCT02750267||
718427|NCT02749903||
718428|NCT02749799||
729998|NCT01795495||
717868|NCT02822235|Participants took part in the study at the 14 investigative sites in Brazil from 11 October 2016 to 19 Feb 2018.|Participants diagnosed with infectious bowel disease (IBD)- Crohn's disease (CD) or ulcerative colitis (UC) were observed to collect the retrospective data on Day 1. Participants with active disease at Day 1 entered Prospective phase and were followed up for a period of 12 months.
717869|NCT02822222|This trial was conducted at a single Investigational Site (Orange County Research Center) in Tustin, CA. All subject recruitment procedures and materials were reviewed & approved by a central IRB prior to their use. The 1st screening visit was May 31, 2016, the 1st subject was enrolled on June 10, 2016, & the last subject visit was July 7, 2016.|Randomization to treatment took place on Day 4, following the 7-day washout period & the 3-day run-in placebo period. Only subjects that continued to meet eligibility criteria following the Day 4 baseline procedures were randomized.
717870|NCT02821962||
717871|NCT02821910||The subjects were randomly allocated to the 2 treatment sequences (test (T) - reference (R) or R-T) in 3 separate trial parts. There was a wash-out period of at least 35 days between the treatments.Treatments were administered as single doses in the fed state in Parts 1 and 3, and in the fasted state in Part 2.
717872|NCT02821819||
717873|NCT02821715|54 patients were screened, 51 patients were randomized and 48 started the double-blind treatment period|Study starts with open-label run in period with modafinil 300 mg/d. 51 patients met study inclusion/exclusion criteria and entered the run-in period, 48 subjects still fulfilled inclusion criteria after run-in and entered the double-blind period.
717874|NCT02821455||
717875|NCT02821403||
717876|NCT02821338||
717877|NCT02821000||This results disclosure is based on a data cutoff date of 27-December-2017 for the efficacy and safety analyses; at which time 58 participants were ongoing in the study. The data cutoff date for the pharmacokinetics analysis was 20-July-2017.
717878|NCT02820870|All primary care providers at one VA Medical Center clinic were randomized prior to the start of the intervention. Eligible visits were those with patients who were recommended statins by VA/DoD guidelines, but were not receiving them. The intervention was only performed on intervention arm visits during the 3-month intervention duration.|The unit of analysis was the visit during the 3-month intervention, with clustering for provider. Patients who met VA/DoD statin recommendations were excluded from the project. Each time-period (pre-intervention, intervention, post-intervention) are visits, and hence should have different sample sizes.
717879|NCT02820844|This study evaluated the efficacy and safety of GSK1358820 (botulinum toxin type A) in participants with overactive bladder. This was a multicenter study conducted in Japan.|A total 354 participants were screened, of which, 104 failed screening and 250 were randomized. Of the 250 randomized, 248 received GSK1358820 100 units (U) or placebo. One participant did not receive treatment due to defective investigational product vial and the other participant was met with protocol exclusion criteria before dosing.
717880|NCT02820597|27 participants were enrolled and treated with bilateral cryotherapy of the nasal passage (54 treatments).|
717881|NCT02820324||
717882|NCT02820038||
717883|NCT02819908||
717884|NCT02819804|The study was activated for accrual on August 24, 2016 with the first patient enrolled and treated on the study on August 17, 2017. The study was terminated before the accrual goal of 22 patients was reached due to funding issues and slow accrual.|
717885|NCT02819726|This was a global study conducted in 66 study centres. The first participant entered the study on 11 October 2016 and the date of the last participants last study visit was 07 November 2018.|
717886|NCT02819557|Participants aged ≥2 to <5 years old with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation in the dystrophin gene were recruited for this study.|Participants in the Evaluable Population included all participants who received at least 1 dose of ataluren and had a baseline and at least 1 postbaseline measurement for Timed Function Test (TFT), North Star Ambulatory Assessment (NSAA), or response to the palatability of ataluren questions.
717887|NCT02819310||
717888|NCT02819297||1020 subjects were consented and entered into a two-week run-in period to confirm constipation status (subjects were required to average < 3 complete spontaneous bowel movements per week). Following the run-in period, 603 subjects qualified for randomization.
717889|NCT02819284||909 subjects were randomized, 4 of which were not included in any analysis population as agreed upon with the FDA. 3 individuals had participated in more than one study therefore the data for their second-participation were not included and 1 individual did not receive treatment.
717890|NCT02819011||
717891|NCT02818998|Study was conducted at multiple centers in 14 countries between 16-Nov-2016 (first participant first visit) and 24-Sep-2019 (last participant last visit).|"A total of 500 participants were screened in this study. Of these, 37 participants did not enter the treatment period (31 were screening failures; 3 were lost to follow-up; 2 had an adverse event (AE) and 1 was not randomized due to an other reason). A total of 463 participants were randomized and received treatment."
717892|NCT02818946||
717893|NCT02818920||Thirty-five subjects consented to the study. Two subjects withdrew consent before receiving protocol treatment and three were deemed ineligible.
717894|NCT02818777||
717895|NCT02818569||All 15 participants completed both arms (dexmedetomidine and placebo) for the study. After being randomized and completing the first arm, patients completed the alternative arm thereafter.
717896|NCT02818244|All subjects who met inclusion criteria and had no exclusions were enrolled. All subjects who were consented, participated and completed the study wearing a device on each wrist.|
717897|NCT02818114|We recruited from veterans screening for Prolonged Exposure (PE) at a Midwestern VA between 6/2017 and 3/2018. Note that the study was open between 10/2016 and 3/2018, because between 10/2016 and 2/2017 we were enrolling focus groups to refine the intervention to be tested in the clinical trial; the focus groups were not the clinical trial..|31 participants were referred by outpatient therapists. 9 were not interested, and 6 did not meet institutional criteria to start PE. 16 consented to interview screening. 5 did not meet criteria to start PE, 2 were lost to follow-up before starting, and one chose not to start PE.
717898|NCT02818036||
718429|NCT02749370|This study was conducted at 22 centers in the United States from 18 May 2016 to 06 December 2017.|
718430|NCT02749201||
718431|NCT02748928||
718432|NCT02748889||
717900|NCT02817828||A total of 1,577 participants aged 18-50 years were enrolled. Of those, 1,553 started the study treatment. Twenty-four participants did not start the treatment for the following reasons: consent withdrawn (8), unspecified reason (5), protocol deviation (3), pregnancy (4), lost to follow-up (3), and adverse event not related to bleeding (1).
717901|NCT02817763|At clinical site|The study recruited 45 eligible patients. However, five patients were excluded before assignment to groups. One recruited patient never presented for treatment and four declined to proceed.
717902|NCT02817594|Participants chronically infected with hepatitis C virus (HCV) were enrolled at 9 centers in the Netherlands.|Participants were prescribed the interferon-free combination regimen of paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) at the discretion of the physician in accordance with local clinical practice and label.
717903|NCT02817555||
717904|NCT02817516|Participants took part in the study at 1 investigative site in the United States from 30 June 2016 to 22 August 2016.|Non-Japanese healthy participants were enrolled in Part 1 to receive TAK-828 as multiple rising dose of: 15 milligram (mg) in Cohort 1, 45 mg in Cohort 2, and 75 mg in Cohort 3. Study was terminated before the start of 100 mg in Part 1 Cohort 4, and 45 mg and 100 mg in Japanese participants in Part 2 due to findings from 13-week toxicology study.
717905|NCT02817087|38 patients were screened 7 were screen fails. 2 withdrawn. 14 treated-Active, 15 treated-placebo.|
717906|NCT02816723||
717907|NCT02816710|The study was performed in the department of Ophthalmology, Ruijin Hospital, affiliated with Shanghai Jiaotong University School of Medicine, between July 2016 and September 2017.|
717908|NCT02816398||
717909|NCT02816346|Subjects were recruited from the recruiting range of Cincinnati Children's Hospital Medical Center (CCHMC) via word of mouth and advertisements in multiple formats including but not limited to newspapers, fliers, e-mails, and the CCHMC website.|
717910|NCT02816138||
717911|NCT02815982|Caregivers and PCS were recruited as dyads, however, caregivers participated in the intervention (NOURISH-T vs EUC) and completed measures. PCS did not participate in the intervention and only completed measures. Outcomes are noted by whether caregivers or PCS completed measures.|
717912|NCT02815735||Four subjects were not dispensed lenses due to screen failure. Seven subjects discontinued from the study due to the investigational site withdrawing from the study.
717913|NCT02815709||Pre-Surgical Entry Criteria
717914|NCT02815670|An open-label, uncontrolled case series trial, with a single treatment arm of idarucizumab in patients with venous thromboembolism treated with dabigatran etexilate in ongoing Boehringer Ingelheim pediatric clinical trials (1160.106 and 1160.108). Treatment period was around 1 day followed by 29 days of safety follow-up period.|All subjects were screened for eligibility to participants in the trial. Subjects attended specialist sites which would then ensure that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be assigned to treatment groups if any one of the specific entry criteria were violated.
717915|NCT02815644||This is a Open-label, randomised, single-dose, two-sequence, crossover design
717916|NCT02815397||
717917|NCT02815293|Of the 36 participants who enrolled in the study, 18 were randomized and received intervention to comprise the safety and Intent to Treat (ITT) populations|This study was terminated
717918|NCT02815280|The study was conducted at 36 sites in the United States and one site in the Dominican Republic from 11 May 2016 to 13 October 2017.|The study consisted of a varied screening period. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All assessments at screening were done as per the schedule of assessment.
717919|NCT02815267|The study was conducted at 35 sites in the United States and one site in the Dominican Republic from 06 May 2016 to 13 October 2017.|The study consisted of a varied screening period. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All assessments at screening were done as per the schedule of assessment.
717920|NCT02814890|Sixty-five patients were initially recruited in Auguest, 2016.|The participants who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions would be wash out.
717921|NCT02814656|This study was conducted at a single centre in the UK. The first patient was screened in June 2016 and the last patient visit was in November 2016.|A single dose of 300 μg AZD8871 or placebo was administered to 8 healthy subjects following a 3-day washout period, dosing then continued for a further 12 days. Following the 1st cohort, 2 further cohorts of 8 subjects each were administered multiple ascending doses of AZD8871 in the same manner as Cohort 1.
717922|NCT02814643|This study was conducted at 30 study centers in the United States between 01 July 2016 and 24 January 2017|The study duration was up to 23 weeks, consisting of an initial screening period lasting up to 3 weeks, a 12-week treatment period, and a follow-up visit 8 weeks after the last dose of study drug
717923|NCT02814565|Participants took part in the study at 10 investigative sites in the Russian Federation from 12 October 2016 to 14 March 2017.|Participants with a diagnosis of acute cervical and/or lower back pain due to muscle spasms of local origin were enrolled equally in one of two treatment groups: Cyclobenzaprine HCl 15 mg or placebo.
717924|NCT02814448|Participants were between the ages of 25 and 65 to be eligible for the study|
717925|NCT02814279|At clinical site|The study recruited 45 eligible patients. However, three patients were excluded before assignment to groups. Two recruited patients never presented for treatment and one declined to proceed.
717926|NCT02814227||
717927|NCT02814175|There were 246 participants randomized; 1 participant did not receive study medication. Upon completion of Part 1, eligible participants continued to Part 2, so no additional participants were enrolled in Part 2.|Intent-To-Treat Part 1 (ITT Part 1) population comprised all participants randomized and received at least 1 dose of study medication in Part 1. ITT Long Term (ITT LT) population included all participants who continued to Part 2 and received at least 1 dose of Part 2 study medication; no additional participants were enrolled into Part 2.
718071|NCT02792062|Participants took part in the study at 1 investigative site in Japan from 04 July 2016 to 31 August 2016.|Healthy premenopausal adult female participants were enrolled and randomized in this 3 period cross over study in 1 of 6 administration sequences to receive TAK-385 40 milligram (mg) under fasted conditions without breakfast, before breakfast, or after breakfast.
717928|NCT02813694|The study was designed to enroll adults with CABP for which oral antibacterial therapy was appropriate. Subjects with PORT score of II, III and IV were eligible. The first subject was randomized in August 2016 and the last subject was randomized in December 2017|Subjects who met inclusion criteria and did not meet exclusion criteria were randomly assigned to a treatment group. Administration of study drug was expected to occur as soon as possible after the diagnosis of CABP with all Screening/baseline assessments expected to be completed within 24 hours before the first dose of study drug.
717929|NCT02813681||
717930|NCT02813577||
717931|NCT02813551||
717932|NCT02813473|223 patients with presence of 3 vessel dissease or left-main disease were enrolled in 6 centers in Europe to assess the coronary artery disease of the 223 patients randomized with either coronary CTA or conventional angiography blinded to the other modality.|
717933|NCT02813265||918 subjects were randomized, 3 of which were not included in any analysis population as they had participated in more than one study. The data for the second-participation for these 3 individuals were not included in any analysis population as agreed upon with the FDA.
717934|NCT02813070|The study was conducted at 5 centers in Japan and 1 center in Korea. A total of 87 participants were enrolled and screened in the study, of whom, 17 withdrew prior to dosing and 70 participants received Flutemetamol F 18 injection.|Participants were assigned into 3 groups based on the baseline diagnosis of probable Alzheimer's disease (pAD), amnestic mild cognitive impairment (aMCI) or healthy volunteers (HVs). All screened participants underwent diagnostic-quality anatomic brain magnetic resonance imaging (MRI) during screening period.
717935|NCT02812342||
717936|NCT02812238||
717937|NCT02812186||
717938|NCT02811965||
717939|NCT02811913||
717940|NCT02811640||Two patients had to be excluded from the analysis due to difficulties zeroing the Stryker pressure monitor at the time of surgery.
717941|NCT02811445|Recruitment dates: 5/2016 to 2/2018 at the Tufts University Human Nutrition Research Center on Aging (Boston, MA). Sedentary older adults were recruited from a database of older adults, and via advertisements posted on HNRCA bulletin boards and online media.|Exclusion criteria included a SPPB score of 9 or 10, a BMI ≥ 35 kg/m2, acute or terminal illness, myocardial infarction in the past 6 months, unstable cardiovascular disease, MMSE score < 23, blood pressure > 150/90 mm Hg, androgen therapy in males, estrogen therapy in females, and others.
717942|NCT02811419||
717943|NCT02811302||
717944|NCT02811159||Participants who had successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] were enrolled in this study.
717945|NCT02810873||
717946|NCT02810509||
717947|NCT02810457|Screening occurred at 146 centers in 24 countries (randomized at 136 centers, 24 countries) in Belarus, Bosnia & Herzegovina, Bulgaria, Croatia, Georgia, Germany, Greece, Hungary, Italy, Japan, South Korea, Peru, Philippines, Poland, Romania, Russia, Serbia, Spain, Taiwan, Thailand, Turkey, Ukraine, US and Vietnam. No screening occurred in Canada.|Of a total of 1023 patients who signed informed consent and were screened, 292 patients were not randomized. Of the 731 randomized patients, 2 patients were randomized in error and never received any study treatment, and 1 patient was randomized but withdrew consent prior to receiving any study treatment.
717948|NCT02810327||
717949|NCT02809976||
717950|NCT02809911||Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.
717951|NCT02809859||
717952|NCT02809846|Study was conducted at the Scripps Mercy Oncology Clinic in San Diego California. Enrollment began on Wednesday 7/5/216. The last participant completed on 7/27/17 . The trial was terminated before reaching the projected sample size because of unanticipated difficulties in the recruitment and retention of individuals with targeted conditions.|
717953|NCT02809833||
717954|NCT02809430||Over the 3-night run-in period with CPAP, 28 of the 90 patients enrolled (31%) were excluded: 14 with CPAP use <3 hours, 5 with no evidence of OSA, and 9 with evidence of central or complex sleep apnea. A total of 62 eligible patients (69%) completed the run-in with evidence of OSA and chose to continue CPAP.
717955|NCT02809183||
717956|NCT02809118|"The study was prematurely discontinued while recruitment was still low (56 out of the planned 300 subjects).
~Recruitment started on 16 June 2016. On 28 November 2017, recruitment was stopped. This study was conducted in USA, Canada and South Korea."|In subjects assessed within the first 24 hours from Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) onset, mean hearing threshold had to be confirmed by a second measure that was conducted, at the earliest, 24 hours after the onset of ISSNHL.
717957|NCT02809053|One hundred and one study centres in 29 countries participated in the study. The first participant was enrolled into the study on the 18 January 2017 and the last participant completed week 28 (primary analysis cut-off) on the 17 July 2019.|A total of 455 participants were consented for the study and 315 participants were randomized in a 1:1 ration to receive SAIT101 (n=157) versus MabThera (n=158).
717958|NCT02808975||Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit
717959|NCT02808390|First Patient IN: 28 November 2016 ; Last patient OUT: 31 July 2017|"The study consisted of 3 phases:
~Screening Phase - up to 4 weeks
~Double-blind Placebo-controlled Phase - Weeks 0 to 8
~Follow-up Phase - Week 9"
717960|NCT02808338|A multi-site study that accrued over 2016 and into the middle of 2017.|
717961|NCT02808312|Participants were enrolled at study sites in the United States (US) and New Zealand. The first participant was screened on 13 July 2016. The last study visit occurred on 16 October 2018.|109 participants were screened.
717962|NCT02808130||
717963|NCT02808052|A total of 9 subjects were assigned to one of three groups (Mild, Moderate, or Severe) based on degree of renal impairment. All 9 subjects were enrolled in the study from 29-May-2017 to 17-Dec- 2017, at the Univ Hosp Cologne, Germany.|Following the change of ownership of Minocin IV from The Medicines Company to Melinta Therapeutics, the business decision was made to terminate this study prior to completion as Melinta.
717964|NCT02807948||
718072|NCT02792049||
718073|NCT02791945||
729999|NCT01795105||
717965|NCT02807623|A total of 315 active-duty US Military Service Members due to receive injectable influenza vaccine (IIV) were recruited via flyers or verbal briefing from the Fort Bragg, North Carolina 82'nd Airborne Soldier Readiness Center and Walter Reed National Military Medical Center between 9/19/2016 and 11/6/2018.|Of these 315 subjects, 15 were excluded due to the following reasons: 4 did not meet inclusion criteria, 2 declined to participate, and 9 are identified as other reasons. 300 were randomized to 1 of 3 arms. However, only 233 of the 300 returned for follow-up visits. Thus results are based on data from those 233 participants with completed data.
717966|NCT02807402|In this prospective, multi-center observational study a total of 522 adult patients chronically infected with hepatitis C virus (HCV) genotype 1 were enrolled by 22 centers in Romania.|
717967|NCT02807376|Recruitment was from July 2016 to July 2017 across 11 hospitals.|In total, 302 subjects were screened, 270 subjects were randomized, and those 32 subjects who were not randomized did not satisfy inclusion or exclusion criteria.
717968|NCT02807259||
717969|NCT02806986|Participants with primary immunodeficiency (PI) requiring IgG replacement were enrolled. Study has 3 stages: Screening/Previous Regimen Phase, Treatment Stage 1 and 2. Total 62 participants entered Previous Regimen Phase, of which 61 entered in Treatment Stage 1 to receive IGSC 20%. Study was conducted in 8 countries from June 2016 to May 2019.|Participants had no SBI within last 3 months prior to screening and were on immunoglobulin G (IgG) replacement therapy (stable regimen via intravenous [IV] or subcutaneous [SC] infusion) for ≥3 consecutive months prior to screening. Participants receiving IVIG prior to study entry must have received a dosage of ≥200 mg/kg per infusion.
717970|NCT02806973||
717971|NCT02806960|4-period, 4 sequence, repeated single dose design with 7 days washout period between each dose.|
717972|NCT02806947||The primary analysis population includes only participants with an AA score of 1 or 2 (n=64 on the prednisone arm, n=58 on the sirolimus arm). Three participants on the prednisone arm and two on the sirolimus arm were excluded because they had an AA score of 3 or missing.
717973|NCT02806895||
717974|NCT02806869||
717975|NCT02806726||Per the protocol, the total number of participants enrolled is 42 (the number of participants who agreed to participate in the study and completed the informed consent process). The total number of participants Started is 7 (the number of participants who were assigned to each Arm/Group).
717976|NCT02806713||
717977|NCT02806544||
717978|NCT02806505||A total of 85 participants were randomly assigned to the two treatment groups (Peginterferon alfa-2a 135 mcg/week and Peginterferon alfa-2a 90 mcg/week). A total of 4 randomized participants did not receive any study drug.
717979|NCT02806414||
717980|NCT02806232||
717981|NCT02806024|Eligible participants were women with suspicion of morbidly adherent placenta (accreta) on imaging, or women with placenta previa and two or more cesareans (CS).|One patient was excluded from the study after consenting to participate, but before delivery. Two consented patients delivered at night, and were unable to be randomized.
717982|NCT02805907||
717983|NCT02805790||
717984|NCT02805647|Children with low energy fractures|without bone diseases such as OI
717985|NCT02804750|All enrolled participants who received at least 1 dose of study drug|
717986|NCT02804594|Our study participants are recruited from the MS Clinic.|Study participants who met the eligibility criteria to enroll in the study are randomized into study medication group or placebo group. Study participants who did not meet the criteria to enter the study treatment period of the study were observed as controls.
717987|NCT02804399||
717988|NCT02803749||
717989|NCT02803580|This was an observational study based on participants newly diagnosed with Idiopathic Pulmonary Fibrosis (IPF) for less than 3 months, who enrolled in 20 Italian Pulmonary Centers highly experienced in the disease management of IPF. Data collection was performed between 30th November 2015 and 15th May 2018.|Data source for this study were medical records usually collected during routine clinical practice other than study-specific questionnaires.
717990|NCT02803138||Safety population: all enrolled participants who received at least 1 dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known. 256 participants enrolled; treatment was not started in 20 participants. The death noted below occurred during the SAE collection period.
717991|NCT02802878||
717992|NCT02802865||
717993|NCT02802592||This study was terminated due to loss of funding and those participants enrolled were not un-blinded to the study team members.
717994|NCT02802514|This crossover study conducted in adult healthy volunteers who were susceptible to motion sickness to explore regional brain activity and connectivity associated with treatment using magnetic resonance imaging (MRI). Participants were randomized to receive single dose of 50milligram (mg) albiglutide and 10microgram (µg) exenatide along with placebo|A total of 10 participants were screened, of which 6 were screen-failures and 4 were randomized. Participants from United States site were part of the study. This was a 2-part study; however, study was terminated early due to portfolio strategic reason and only Part A was completed.
717995|NCT02802501|This was a single center randomized, double-blind, parallel group study to evaluate the efficacy and safety of tafenoquine co-administered with DHA-PQP for the radical cure of P.vivax malaria in Indonesian soldiers. Participants with microscopy-confirmed P.vivax were recruited at 2malaria-free bases in Java following deployment to Indonesian Papua.|A total of 164 participants were screened of whom 14 failed during screening and 150 were randomized to receive dihydroartemisinin-piperaquine (DHA-PQP) only, tafenoquine+DHA-PQP and primaquine+DHA-PQP in a ratio of 1:1:1.
717996|NCT02802449||
717997|NCT02802345|Randomised, double-blind, parallel design comparison of nintedanib 150 milligram (mg) twice daily (bid) and sildenafil 20 mg three times a day (tid) to nintedanib 150 mg bid and placebo matching sildenafil tid administered orally over 24 weeks.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be randomized to trial if any one of the specific entry criteria were not met.
717998|NCT02802319||
717999|NCT02802241||
718000|NCT02802111||
718433|NCT02748863||A total of 251 patients were screened and 214 patients were randomized
718434|NCT02748785||
718435|NCT02748525||
718001|NCT02801942|This was a multi-center, non-drug treatment study to compare differences in immune cells derived from the inguinal lymph nodes (iLN) and peripheral blood of New Onset Type 1 Diabetes Mellitus (NOT1D) participants and healthy volunteers. Participants were enrolled at a single center in United Kingdom.|Participants underwent iLN biopsies by two methods; fine-needle aspirate (FNA) and core needle biopsy. Participants underwent screening followed by study visits and follow-up. A total of 43 participants were screened, of which, 21 were considered as screen failures and 22 were enrolled into the study.
718002|NCT02801877||
718003|NCT02801669|A total of 984 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment at 164 clinic centers in Japan. Of the 984 participants, 982 received treatment.|Participants were assigned to the DU-176b or placebo group in a 1:1 ratio using a stratified randomization method with the CHADS2 index score (≤2, ≥3) as a stratification factor.
718004|NCT02801617|The study raised 120 research subjects, only 116 were selected, 2 left the study before being evaluated for a total of 114. However, 7 subjects were eliminated by: closure of center 1, without monitoring 2, by loss of follow-up 2, non-compliance with inclusion criteria 1 and failure of scrutiny 1, leaving a total of 107 randomized research subjects|
718005|NCT02801578|Recruitment Period: July 2016 to June 2017|
718006|NCT02801396||A total of 116 subjects were enrolled into the study. Of the enrolled subjects 15 were not dispensed a study lens. A total of 101 subjects were dispensed a study lens. Of the dispensed subjects 1 was discontinued and 100 subjects completed the study.
718007|NCT02801370||
718008|NCT02801006||
718009|NCT02800928||This is a cross-over design. Medication arms are within-subject.
718010|NCT02800642|A total of 244 participants were screened in 42 study centers in 8 countries, the first subject first visit was on 10/Jun/2016 and last subject last visit was on 31/Jun/2019|Of the 244 screened participants, 162 subjects completed screening and entered the treatment period
718011|NCT02800356||
718012|NCT02800213||
718013|NCT02800148||
718014|NCT02799784|This is a multicenter, randomized, open label, 2 period crossover complete block design study. Participants (par.) with Chronic Obstructive Pulmonary Disease (COPD) were enrolled across 4 countries: Germany, Spain, the United Kingdom and the United States.|Study consisted of a run-in period of approximately 2 weeks followed by two 8-week treatment periods with a washout of approximately 3 weeks. The total duration of the study was approximately 22 weeks including follow-up. A total of 443 par. were screened, of which 236 par. were randomized (207 par. were pre-screen, screen and run-in failures).
718015|NCT02799472|A total of 39 participants with active early/established Rheumatoid arthritis were randomized across 9 centers in 3 countries from 15 June 2016 to 30 October 2017.|Out of the 88 participants screened for this study, 49 participants were screen failures and 39 participants were randomized and received treatment in the study.
718016|NCT02799381||Safety Data Set: all participants randomized to OMT and all participants randomized to LCIG treatment who had a study tube (NJ or PEG-J) placement procedure. Two participants randomized to the LCIG arm did not have device placement for LCIG infusion and were not included in the safety data set.
718017|NCT02799082|Study period: December 13, 2007 to October 01, 2008. Patients were recruited at 8 study centers in Germany (hospitals and private practices).|128 patients were screened, of whom 122 patients were randomized (41 patients to the vehicle/placebo group, 81 patients to the BF-200 ALA group); 6 patients were screening failures (3 patients refused to participate, 3 patients meet exclusion criteria).
718018|NCT02799069|Multinational / 26 centers sites: Germany (23), Austria (2) and Switzerland (1); 08 Apr 2008: First subject signed informed consent; 21 Aug 2009: Last subject completed clinical part of study|616 patients with actinic keratosis (AK) were planned to be randomized in a 3:3:1 ratio allowing for 20% of non-evaluable patients excluded from the per-protocol set. Due to the low drop out rates, recruiting was stopped after 600 patients were screened. Of those, 571 patients were randomized and 29 patients were screening failures.
718019|NCT02798978|This study was planned to be conducted in 2-parts, however Part 2 was discontinued by the Sponsor prior to its scheduled start. Part 1 was single-dose escalation, sequential group evaluation of intravenously administered GSK1795091 to evaluate the safety and tolerability in healthy participants.|Forty two participants were randomized in Part 1 of which 2 did not receive dose due to abnormal findings during pre-dose examination. Participants were randomized in ratio of 3:1 to receive GSK1795091 or matching placebo.
718020|NCT02798952||
718021|NCT02798861||
718022|NCT02798835||
718023|NCT02798380||
718024|NCT02798354||Of note, initial control data were collected prior to the first Intervention Period
718025|NCT02798315||
718026|NCT02798289||
718027|NCT02797821||
718028|NCT02797678||
718029|NCT02797613||
718030|NCT02797522||
718031|NCT02797132|The study was conducted in 2 parts, Part A and Part B. In Parts A and B, participants received doses of lumacaftor/ivacaftor (LUM/IVA) based on weight. Participants from Part A may have also participated in Part B.|
718032|NCT02797080||
718033|NCT02797054||
718034|NCT02796963|Participants were recruited from July 28, 2016, and followed until August 21, 2017. A total of 1,381 participants were enrolled. Of these, 203, 139, 134 and 203 were recruited from Guangzhou, Jiangmen, Zhuhai and Shenzhen, respectively, while 180, 189, 182 and 151 were recruited from Yantai, Jinan, Qingdao and Jining, respectively.|Overall, the survey link was clicked 36,863 times from 25,141 independent Internet Protocol (IP) addresses, and a total of 2,112 eligible participants finished the questionnaire (many people clicked the survey link but withdrew before the eligible screening). Among these 2,112 participants, 1381 were eligible for the study.
718035|NCT02796924||
718074|NCT02791906|Screening was performed from electronic medical records searcesh for potential study participants, followed by manual review.|After assessing subjects for eligibility via electronic health record reviews (n=529), 522 were excluded due to not meeting inclusion/exclusion criteria (n=506), not being interested in participating upon telephone interview (n=3) and various other reasons (inability to contact, inability to exercise, scheduling difficulties; n=13).
718517|NCT02739269|A total of 200 women who were undergoing in vitro fertilisation treatment in Queen Mary Hospital, Hong Kong, were recruited.|
718036|NCT02796677|Study was conducted on participants with stable chronic obstructive pulmonary disease (COPD), in 11 countries: United States (US), Germany, Poland, Hungary, Bulgaria, Ukraine, United Kingdom (UK), Czech Republic, Spain, Israel & Russia (was not finally started). First participant enrolled was 05 July 2016 & participant last visit was 08 June 2017|Eligible Participants signed informed consent form (ICF) & entered screening (Run-in) period (14 ± 3 days), inclusion/exclusion criteria were checked by medical & COPD history, physical examination, laboratory analysis, electrocardiogram, & COPD severity (COPD Assessment Test [CAT] & post-bronchodilator forced expiratory volume in 1 second [FEV1])
718037|NCT02796651|This study was carried on 132 participants with moderate to severe chronic obstructive pulmonary disease (COPD) & reversible airway disease in the United States of America (USA; 21 sites) & were randomized to one of treatment sequences (each with 5 periods of different treatment, separated by wash-out period of 7 (+/1) days after treatment period).|After signature of the informed consent, participants who were taking prohibited medication performed a wash-out period and were given Atrovent (2 puffs 4 times/day) before Screening and during the run-in period. All participants were provided with rescue drug (albuterol) and Atrovent to be taken during the wash-out between treatment periods.
718038|NCT02796560||
718039|NCT02796352||
718040|NCT02796300|Recruitment period = 01/2017 to 12/2018 Location = UCLA Santa Monica Hospital|No significant events occurred in this study prior to assignment to a group
718041|NCT02796274||
718042|NCT02796092|Patients were recruited based on physician referral in a single specialized center between January 2014 and January 2015. The 1 year follow-up period was finished in February 2016.|
718043|NCT02795832||
718044|NCT02795819|Subjects were recruited from a single academic medical center cancer clinic from July 8, 2016 through November 22, 2016.|
718045|NCT02795780|Enrolled between Aug 2016 and Aug 2017. The only subjects eligible were those who completed the Confirmatory Phase of Study A05 (NCT02016560).|
718046|NCT02795767|Following completion of accrual to Cohort A: Emicizumab QW, enrollment was opened to Cohort B: Emicizumab Q2W and Cohort C: Emicizumab Q4W. Of note, enrollment remained open to Cohort A only for participants who were <2 years old, and enrollment to Cohorts B and C was limited to participants who were 2-11 years old.|
718047|NCT02794974|The patients were recruited as part of the preoperative information discussion. All patients received an intermediate cervical plexus block and a facial nerve block (cervical branch, superficial cervical ansa). The decision on an additional perivascular infiltration was made by an experienced physician on the basis of sonoanatomic properties.|
718048|NCT02794870|Recruitment period was from July to October 2016. Participants were recruited from medical clinics.|
718049|NCT02794844|From 06/16/2015 to 02/20/2017, patients (or in the case of children, the pediatric patient and their parent/legal guardian) were approached for participation after a clinical assessment was performed by a GI provider during an outpatient GI appointment. Study procedures were performed after obtaining proper consent and/or child assent.|
718050|NCT02794766||
718051|NCT02794727||
718052|NCT02794597||
718053|NCT02794480|This is a randomized, multi-center, open-label, cross-over study comparing Placebo ELLIPTA Dry Power Inhaler (DPI) with either Placebo GlaxoSmithKline (GSK) Metered Dose Inhaler (MDI) or Placebo Astra Zeneca (AZ) MDI to assess correct inhaler use. A total of 20 sites in the United States (US) participated in the study.|A total of 329 participants (par) were screened out of which 324 were randomized to sub-study 1 and sub-study 2 in a ratio of 1:1. Each par received at least one-dose of placebo from at least one study inhaler. These par comprised the intent to treat (ITT) population. Par were randomized on the same day as screening.
718054|NCT02794441|Participants were recruited between December 2016 and June 2017 from the ED at the Children's Hospital of Eastern Ontario, a tertiary care academic pediatric hospital located in Ottawa, Ontario, Canada.|
718055|NCT02794246||
718056|NCT02794207||
718057|NCT02794103|Data were collected at the pediatric burn unit of the CHU Sainte-Justine, in Montreal (Quebec, Canada) from June 14, 2016, to January 31, 2017.|Participants sedation levels were assessed after enrolment in the study and the patient was excluded if he/she was too sedated to participate in the experimental intervention.
718058|NCT02793947||
718059|NCT02793856||
718060|NCT02793817||
718061|NCT02793674|This study screened patients admitted to the PICU during the study period (September 2014 to June 2016) who were <3 years of age and started on high flow nasal cannula by the clinical team.|Of the 54 patients who met eligibility criteria on screening, 39% (N=21) underwent high flow nasal cannula flow titrations and had effort of breathing measurements taken.
718062|NCT02793232||Study was conducted in 3 parts: Part A (4-period cross-over design), Part B and C (single period, parallel design).
718063|NCT02793154|This study compared effects of repeated doses of albiglutide and exenatide in type 2 diabetes mellitus. This study was conducted in two parts; first cohort of participants (Par.) were planned to receive exenatide (Part A) and second cohort with albiglutide or exenatide (Part B). There were no pre-specified Primary or Secondary endpoints for Part A.|This study was terminated during exploratory Part A due to the difficulty with enrollment and Part B was cancelled. Hence, Par. received only exenatide subcutaneous (SC) injection in Part A. The data was only collected in Part A and no Par. were enrolled in Part B. All the 4 enrolled Par. completed Part A and no Par. was withdrawn from study.
718064|NCT02793128||
718065|NCT02792829||
718066|NCT02792777||
718067|NCT02792699|"This study was conducted at 57 centers in Bulgaria, Estonia, Germany, Hungary, Poland, and the United States (US).
~Eligible participants were men and women aged 18 to 80 years, inclusive, with a diagnosis of rheumatoid arthritis (RA) for at least 6 months."|Participants were randomized in a 1:1:1 ratio to 1 of 3 groups, stratified by geographic region (North America vs Eastern Europe vs Western Europe), seropositivity (rheumatoid factor [RF]-positive and/or cyclic citrullinated peptide [CCP]-positive vs RF-negative and CCP-negative), and number of prior biologic therapies used for RA (1 vs > 1).
718068|NCT02792517|This study was conducted at 3 centers in the United States of America. Participants were enrolled from 12 February 2016 to 15 April 2016.|
718069|NCT02792231||There were 1280 patients screened
718070|NCT02792218||A total of 1277 patients were screened, of whom 927 patients were randomized into the study.
718075|NCT02791763|This was an open-label, active-controlled, parallel-group, multi-center study to compare the efficacy (verification of non-inferiority) and safety of GSK1278863 (daprodustat) versus epoetin beta pegol in Japanese non-dialysis (ND) participants, including an open-label non-comparative cohort of peritoneal dialysis (PD) participants.|A total of 56 centers, contracted in Japan, enrolled and randomized participants. A total of 455 participants were screened and 355 participants were enrolled and randomized in this study.
718076|NCT02791659||
718077|NCT02791516|This study was conducted at 10 centers in South Korea. Participants were enrolled from 16 January 2017 to 17 August 2017.|Participants were randomized in a 1:1 ratio to receive either romosozumab 210 mg subcutaneously (SC) QM or matched placebo SC QM. Upon completion of the 6-month treatment period, participants were followed for an additional 3 months.
718078|NCT02791490||
718079|NCT02791438|The study was conducted at 17 investigative sites in Japan from 18 August 2016 to 04 June 2019.|Following a placebo run-in period, pediatric patients with hypertension received azilsartan at starting doses of 2.5 mg for patients < 50 kilograms (kg) and 5 mg for patients ≥ 50 kg.
718080|NCT02791308||
718081|NCT02791269||
718082|NCT02790788||
718083|NCT02790736||
718084|NCT02790606|The study was conducted at 14 active sites in the US. Of 181 consented subjects,110 were treated with device and 71 were considered screen failures. No site treated more than 20% of the total number of subjects.The first subject was treated Aug, 3, 2016 and the last one Feb. 27, 2017. The last 24-month follow-up contact occurred Mar. 16, 2019.|
718085|NCT02790463||
718086|NCT02790281|Subjects were recruited from amongst the subjects seeking medical support due to present, active moderate to severe ulcerative colitis or Crohn's disease (newly diagnosed or during disease relapse) at four sites in two countries (Denmark and Sweden) between 10 Dec 2014 to 20 Aug 2015.|
718087|NCT02790073||
718088|NCT02789410||
718089|NCT02789176||
718090|NCT02789111|Forty-nine opioid-naive participants undergoing spine surgery between 2016 and 2018 with neurological monitoring were screened and included for eligibility. A total of 24 patients were assigned to the active group and 25 were assigned to the placebo group. One patient from the alvimopan group had surgery canceled, and thus was excluded from further analysis. In the placebo arm, 4 patients were recruited but withdrew from the study.|All 49 consented participants were assigned to an arm.
718091|NCT02788747||
718092|NCT02788656||
718093|NCT02788513|This is a multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy and safety of orally administered BI 425809 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.|"Subjects were screened prior to participation and attended a specialist site which ensured that they strictly met all inclusion/exclusion criteria. Subjects were not to be allocated to a treatment group if any of the criteria were violated.
~One subject was randomized by error via Interactive Response Technology (IRT) but never took a drug."
718094|NCT02788474|The trial comprised of 2 treatment periods (52 weeks). The first treatment period was a 12-week, randomised, double-blind, placebo-controlled, parallel-group period whereas the second treatment period was a 40-week, single-arm, open-label, active treatment (nintedanib 150 milligram (mg) twice daily (bid)) period.|Participants with idiopathic pulmonary fibrosis (IPF) were eligible for the trial if they fulfilled all of the inclusion criteria and none of the exclusion criteria.
718095|NCT02788357||
718096|NCT02788279|A total of 490 participants were screened of whom only 363 participants were randomized.|
718097|NCT02788201||
718098|NCT02788188||
718099|NCT02788175||
718100|NCT02788097||
718101|NCT02787863|IRB approval - 05 SEP 2012 (protocol #122, Samara State Medical University). Dates of recruitment period - 06 SEP 2012 - 07 JUL 2013. FPFV - 06 SEP 2012. LPLV - 07 JUL 2017. Types of location - Samara State Medical University, Institute of Sera and Vaccines RAS (Russian Federation).|219 patients were examined and monitored for 4 years. Distributed in a row, first to the PCV13 group, then to the PPV23, PPV23/PCV13 and PCV13/PPV23 groups for COPD and asthma.
718102|NCT02787694||
718103|NCT02787681||
718104|NCT02787655||
718105|NCT02787564||
718106|NCT02787551|The study was conducted at 112 sites in 9 countries. A total of 840 participants were screened between 06 July 2016 and 01 November 2017, of which 326 were screen failures. Screen failures were mainly due to glycated hemoglobin (HbA1c) level lesser than (<)7% or more than (>)9% at screening visit.|A total of 514 participants were randomized in 1:1 (Insulin Glargine/Lixisenatide fixed ratio combination [FRC] or glucagon-like peptide-1 receptor agonist [GLP-1 RA]) ratio. Randomization was stratified by values of HbA1c at screening (<8%, >=8%) & GLP-1 RA subtype at screening (once/twice daily [QD/BID], once weekly [QW] formulations).
718107|NCT02787304||
718108|NCT02787291||
718109|NCT02787083||
718110|NCT02787057||
718111|NCT02786953||1 participant consented, completed baseline data, then withdrew
718112|NCT02786927|Eligible participants who met the inclusion criteria at screening were randomized to use ELLIPTA inhaler and Handihaler inhaler in a crossover manner at Visit 1 and Visit 2 once daily for 5-9 days. At Visit 3, participants were asked to complete the inhaler preference questionnaire.|A total of 227 participants with diagnosis and documented history of chronic obstructive pulmonary disease (COPD) were screened for this open-label, cross-over study, of which 13 were screen failures, 2 were randomized by error and did not receive treatment and 212 participants entered the study treatment phase.
718113|NCT02786901||
718114|NCT02786836|Patients with acute liver failure (ALF) who were enrolled into the ALF Study Group Registry at 11 participating investigative U.S. sites were screened for eligibility. In March 2018, patients with acute liver injury (ALI) not related to acetaminophen overdose (APAP) and enrolled into the ALFSG Registry were included and screened for eligibility.|
718115|NCT02786810||
718116|NCT02786771||In reference to comment [2] we had 126 participants that were enrolled in the study but only 125 that started the study. One participant that signed the consent form did not pass the eligibility criteria and therefore was not randomized into a study group and did not start the study.
718117|NCT02786719||
718118|NCT02786537|Participants were consented at 34 US centers Between June 2016 and March 2018. Patients were screened for insurance that included SOF/LDV on formulary. However, following randomization, some participants were unable to obtain SOF/LDV through insurance and instead received 1 of 2 other HCV regimens.|This study initially (Phase 1) randomized subjects to receive 1 of 3 HCV drug regimens (EBR/GZR +/- RBV, LDV/SOF +/- RBV, or PrOD +/-RBV). In phase 2 of this study, randomization to PrOD regimen was discontinued and newly enrolled subjects were randomized to either EBR/GZR +/- RBV or LDV/SOF +/- RBV. Data was analyzed via original 'randomization' and as subjects were 'actually treated (regimen actually received)'.
718119|NCT02786355||This study design involves a cross-over of participants (i.e., participants are randomly assigned to one of the four groups after which they crossover to the other 3).
718120|NCT02786004||
718121|NCT02785913||31 participants were enrolled. However, 4 were deemed ineligible and 1 died prior to receiving study treatment. Thus 26 participants were eligible. Of these, 21 were PI3K GNE-positive (had at least one mutation that was possibly associated with clinical benefit of PI3K inhibitors), and were included in the primary analysis population (PAP).
718122|NCT02785900||
718123|NCT02785770||
718124|NCT02785588||
718125|NCT02785458||
718126|NCT02785432||
718127|NCT02785406||
718128|NCT02785354|The study ENGEL 2 is a real-world historical cohort study in the French nationwide healthcare claims and hospitalization database (SNIIRAM) including new users of DOAC or VKA for nonvalvular atrial fibrillation (NVAF) in 2013 with a follow-up for one year (main objective).|The main objective was to compare the risk & effectiveness for dabigatran vs VKA, & for rivaroxaban vs VKA. The main analysis was done for hdPS matched patients (pts.) with atrial fibrillation (AF) diagnosis information in the database.
718129|NCT02785185||
718130|NCT02785172||
718131|NCT02785159||
718132|NCT02784925||
718133|NCT02784834||
718134|NCT02784704|Subjects with a diagnosis of complicated intra-abdominal infection (cIAI) requiring surgery were recruited into this study. Subjects were recruited in 65 centers worldwide. The first subject enrolled on 13 October 2016 and the last subject completed on 19 May 2017.|
718135|NCT02784613||
718136|NCT02784587||
718137|NCT02784548||
718138|NCT02784444||
718139|NCT02784275||
718140|NCT02784106||The study consisted of a 12-week double-blind treatment period and a 26-week open-label extension period. Primary and secondary outcome measures were planned to be analyzed for double-blind treatment period only.
718141|NCT02783898||243 patients randomised. 1 participant removed after randomisation as did not meet inclusion criteria. 242 patients allocated to arms.
718142|NCT02783820||
718143|NCT02783768||"There were a total of 12 subjects enrolled. 6 subjects were randomized to E-cigarette first, of which 5 completed the full protocol. 5 subjects were randomized to Sham first, all 5 of whom completed the full protocol. 1 subject was consented but not randomized."
718144|NCT02783729|Participants took part in the study at 67 investigative sites in the United States, Spain, Germany, Canada, United Kingdom, and Italy from 31 May 2016 to 30 January 2018.|A total of 3537 participants were screened, of which 1006 participants were randomized to the treatment period. All participants who were subsequently randomized completed a Run-in Period before randomization to treatment period.
718145|NCT02783599|Participants are considered to have completed the study if they completed one cycle of monotherapy and all 6 cycles of combination therapy.|
718146|NCT02783573|This study consists of Placebo-Controlled Treatment Period (Weeks 0 to 78) and Delayed-Start Period (Weeks 78 to 156).|In Period 1, per the protocol, placebo-controlled groups (Placebo for 78 weeks then Lanabecestat 20 mg; Placebo for 78 weeks then Lanabecestat 50 mg) were combined to form one placebo group. As study terminated early and very few participants entered into the period 2, the arms in period 2 are combined based on dose exposure for ease of comparison.
718147|NCT02783443||
718148|NCT02783170||
718149|NCT02783066||
718150|NCT02783027||
718151|NCT02782923||
718152|NCT02782676||"15 subjects are consented but not randomized or treated in the study.
~13 subjects were randomized but did not receive study OVD in either eye."
718153|NCT02782377||
718154|NCT02782364|Patients attending clinic for routine evaluation of faecal incontinence were approached to particpate in this study|
718155|NCT02782325||1 patient after screening since he met an exclusion criterion. 6 patients went on to randomization
718156|NCT02782169||
718157|NCT02781844|This study was conducted in North America and Europe between 04 March 2017 (first participant first visit) to 08 March 2019 (last participant last visit).|A total of 34 participants were enrolled and 33 completed the study. The study consisted of two treatment periods (Treatment period I and II) with four cohorts. Cohort I included Sequence AB and BA. Cohort II included Sequence CB and BC. Cohort III included Sequence DE and ED, Cohort IV included Sequence FE and EF.
718158|NCT02781818|Patients presenting to an academic dermatology department in a subspecialty hidradenitis suppurativa clinic were enrolled during clinic visits between 6/20/2016 and 5/17/2017|The design allows for individual subjects to have multiple lesions randomized to distinct treatment arms, which means a single subject could be included as participants in multiple arms. This results in the total participant number calculated by adding participants in each arm to be higher (55) than the number of subjects enrolled (32).
718159|NCT02781649||
718160|NCT02781571|Participants were enrolled at study sites in Spain, Switzerland, and the United Kingdom. The first participant was screened on 27 July 2016. The last study visit occurred on 28 July 2017.|85 participants were screened.
718161|NCT02781558|Participants were enrolled at study sites in Spain. The first participant was screened on 29 July 2016. The last study visit occurred on 27 October 2017.|
718202|NCT02776670|Subjects were recruited from 14 study centers located in Australia (2), Taiwan (1), Singapore (1), United Kingdom (1) and the US (9).|Of the 308 enrolled, 77 were exited as screen failures prior to randomization. This reporting group includes all randomized and treated subjects (231).
718203|NCT02776644||
718518|NCT02739100||
730679|NCT01748240||
718162|NCT02781454|Subjects were enrolled at 9 Northeast ALS Consortium (NEALS) centers in the US. These NEALS centers were academic clinical research centers with established practices where sporadic ALS (sALS) patients are regularly seen and treated.|Within 21 days prior to treatment assignment, patients were screened for eligibility based on inclusion/exclusion criteria. Failure to meet any of these criteria at the time of this screening would result in exclusion from the study, and these patients would not be assigned to a treatment group.
718163|NCT02781324||
718164|NCT02781311||
718165|NCT02781051||
718166|NCT02780869|First subject completed follow-up: August 19, 2016 Last patient completed follow-up: January 18, 2017|Subject enrollment occurred after the subject met preoperative eligibility criteria, gave written informed consent, and met intraoperative eligibility criteria. Subjects were randomized and treated subsequent to enrollment. Subjects could withdraw or be withdrawn from the study at any time after enrollment, including prior to treatment.
718167|NCT02780856|"Patients were recruited by 5 Investigators from 4 UK, dental practices between 14 January and 04 May 2017.
~110 patients attended Visit 1 and were imaged with the Calcivis System, therefore data from 110 patients are included in the safety and agreement populations."|
718168|NCT02780765||
718169|NCT02780700|This was an exploratory, phase II multi-center, non-comparative, open-label, randomized trial to assess the efficacy and safety of nintedanib alone, or in combination with capecitabine in patients with refractory metastatic colorectal cancer.|"Patients eligible for this study were to be randomized in a 1:1 fashion to receive either nintedanib alone or combination with capecitabine.
~One patient with combination therapy entered study, no patient with nintedanib alone entered study."
718170|NCT02780687|This study was a Phase II open label single arm exploratory trial of oral afatinib monotherapy following platinum failure for patients with advanced/metastatic urothelial tract carcinoma with genetic alterations in ERBB receptors.|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
718171|NCT02780661|All participants were recruited at a single center in United Kingdom.|A total of 25 participants were screened, out of which 19 participants were randomized to the study, 6 participants were not randomized because of screening failure.
718172|NCT02780622||
718173|NCT02780388|The study was conducted from 12 May 2016 to 09 Aug 2018 in Poland and the United States of America.|A total of 117 participants were screened in the study, out of which 60 were screen failures. A total of 57 participants were randomized in this study.
718174|NCT02780349||
718175|NCT02780167||A total of 269 participants were randomized. There were 2 participants who were randomized but did not receive any study treatment. All other participants were treated.
718176|NCT02780115||Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study.
718177|NCT02779543||
718178|NCT02779491||
718179|NCT02779166||
718180|NCT02779075||
718181|NCT02778880|This clinical trial took place at a tertiary care children's hospital emergency department from March 2016 to February 2017. The study sample was identified through an established triage process identifying children with an acute painful extremity injury. These patients were ages 8-17 years with a visual analog scale (VAS) score greater than 35 mm.|
718182|NCT02778867|Participants were recruited from eosinophilic esophagitis specialty clinics (10 sites) in the USA between May 20, 2016 and March 2019|143 participants screened, 14 excluded (8 did not meet inclusion criteria, 1 met exclusion criteria, 5 withdrew during screening), and 129 randomized
718183|NCT02778555||
718184|NCT02778204|Accrual occurred between June 2017 and July 2019 in Kenya, Thailand, South Africa, and the United States at 9 different medical clinic sites. Pregnant mothers were screened and subsequently enrolled for 1 day at the same day their newborn infants were enrolled (within 3 days of life).|The sample size of the study (47) represents the infants enrolled. As multiple births are disallowed in the study, this also represents the total mother-infant pairs.
718185|NCT02778152||
718186|NCT02778113|This was a four-period crossover study in which participants received a single dose of study drug in each period, with seven days between each dose.|
718187|NCT02778100||
718188|NCT02778074||
718189|NCT02777944||
718190|NCT02777931||
718191|NCT02777918||
718192|NCT02777827|"This study was conducted at four sites in Germany.
~The first patient was screened 21 June 2016, the last patient visit was 29 November 2016."|In total, 42 patients were screened; 30 patients were eligible to participate and were randomised.
718193|NCT02777749||
718194|NCT02777268|Recruitment Area: United Kingdom Location: Phase 1 Unit|
718195|NCT02777242|In total, 66 patients were enrolled, of which 65 patients were randomized and were included in the Safety Population.|The Safety Population included all patients who were randomized and took at least one dose of Investigational Product. The Safety Population was used as the denominator in percentage calculations.
718196|NCT02777125||
718197|NCT02777086|Recruiting for the study began in September, 2015 and extended through February, 2019. Recruitment occurred in probation offices in two large counties in Texas and two residential substance abuse treatment centers for people on probation.|
718198|NCT02777021||
718199|NCT02776904||
718200|NCT02776774||
718201|NCT02776683|This was Phase IIIb, open-label, multicenter, multinational, single-arm trial. Patients with previously untreated metastatic colorectal cancer (mCRC) were enrolled. From 21December2017, Sponsor recommended that patients should be switched from BI 695502 to the reference product Avastin® as soon as it was available at the respective clinical site.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that they (the patient) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
718204|NCT02776553|227 Subjects were recruited from the UAMS liver transplant clinic. 207 were excluded for meeting exclusion criteria.|
730680|NCT01748227||
718205|NCT02776033|This was a repeat dose study in participants with active plaque-type psoriasis. Participants received either GSK2982772 60 milligrams (mg) or placebo orally twice daily (BID) in Cohort 1 and either GSK2982772 60 mg or placebo orally three times daily (TID) in Cohort 2. The study was conducted at 4 centers in Canada.|A total of 100 participants were screened, of which, 65 participants were enrolled in the study.
718206|NCT02775916||
718207|NCT02775903|This study consisted of 2 cohorts: • Adults with previously untreated intermediate, high or very high risk myelodysplastic syndromes (MDS) not eligible for hematopoietic stem cell transplantation (HSCT). • Adults with previously untreated acute myeloid leukemia (AML) ≥ 65 years and not eligible for HSCT with intermediate or poor cytogenetic risk.|Within each cohort participants were randomized in a 1:1 ratio to receive either azacitidine plus durvalumab or azacitidine alone. Randomization was stratified according to cytogenetic risk: • Very good, good and intermediate versus poor and very poor for MDS • Intermediate versus poor for AML Results are up to the data cutoff of 31 October 2018.
718208|NCT02775864||
718209|NCT02775617||
718210|NCT02775435|Interim analysis data cutoff date: 03-Apr-2018. Of the 559 randomized participants, 193 were ongoing and 75 participants randomized to chemotherapy had switched to receiving protocol-specified pembrolizumab (MK-3475). Interim results are for randomized treatment only.|
718211|NCT02775344||3 women have been enrolled into the study with informed consent signed. However, their operations were rescheduled, thus did not include in the randomization.
718212|NCT02775240|The study was conducted in a single center in the United States between 16 August 2016 (first participant first visit) and 31 August 2016 (last participant last visit).|A total of 18 participants were screened and were enrolled in the study and received the treatment.
718213|NCT02774941||
718214|NCT02774850||610 patients reflects the total number of patients included in chart abstractions; from there exclusion criteria were applied to determine early discharge eligibility. They were assigned to Early Discharge Management and Inpatient Management by chemotherapy course, not by the overall treatment.
718215|NCT02774798||
718216|NCT02774681|The study opened to accrual May 25, 2016 with the first patient being treated on study August 31,2016. the total accrual goal of 25 patients. The study closed to further accrual January 28, 2019 with 12 patients enrolled on the study|
718217|NCT02774616|292 patients completed the informed consent process and signed the informed consent sheet.|278 patients received one or more study devices implanted. 14 enrolled patients did not receive a study device and were excluded from the analysis. Reasons were implantation of other devices than the study devices (N = 8), no implantation of any device for different reasons (N = 5), or withdrawal of consent before implantation (N = 1).
718218|NCT02774343||
718219|NCT02774278||
718220|NCT02774265|We recruited inpatients admitted between January 19, 2016 and November 1, 2016.|
718221|NCT02774213||
718222|NCT02774148||
718223|NCT02773836|The reason there are more participants enrolled at Period 2 (Wave 2 Post-TPD implementation) as compared to Period 1 (Wave 1 Pre-TPD implementation) is because a replenishment sample was recruited in Wave 2.|
718224|NCT02773758|Participants were recruited at a single center in Canada.|A total of 143 participants were enrolled in the study. Out of which 141 participants were randomized.
718225|NCT02773576||The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study
718226|NCT02773537|Recruitment occurred between October 2015 and August 2016. Patients were approached for participation in the study during their pre-op medical clearance clinic appointment.|A total of 107 patients undergoing primary TKA met initial eligibility criteria and were offered participation in the trial. 75 total subjects were randomized and considered enrolled to one of three arms of the study. 32 patients were excluded for various reasons prior to randomization.
718227|NCT02773446||Cohort 2 group A consists of 11 subjects from Cohort 1. These subjects were re admitted for a second admission. The total number of subjects enrolled was 47.
718228|NCT02773368|The trial was conducted at 74 sites in 11 countries as follows: Argentina (3), Canada (5), Finland (6), Hungary (5), India (8), Russian Federation (7), Slovakia (5), Slovenia (4), Spain (6), Switzerland (5) and United States (20).|Subjects with type 2 diabetes mellitus on oral anti-diabetic drug (OAD) therapy with stable daily dose of sodium glucose co-transporter 2 inhibitors (SGLT2i) either as monotherapy or in combination with metformin ± dipeptidyl peptidase-4 inhibitors (DPP4i) ± pioglitazone according to locally approved label for at least 90 days prior to screening.
718229|NCT02772809|Stroke survivors over the age of 18 with hemiplegia, who are three months post event, and have varying levels of impairment in the upper extremities will be recruited. All use of the TheraDrive system will take place at the Rehabilitation Robotics Lab on the ﬁrst ﬂoor of Penn Rittenhouse|
718230|NCT02772757|Experienced hearing-aid users were recruited from the Mountain Home VA Audiology Clinic in Mountain Home, TN|A total of 77 participants were consented. A total of 5 participants did not meet the inclusion criteria and thus were not randomized because they didn't qualify. A total of 72 participants were randomized.
718231|NCT02772666||
718232|NCT02772432||
718233|NCT02771574||
718234|NCT02771522|"Patients were recruited by two Investigators from a routine NHS Orthodontic clinic between 15 February 2017 and 01 May 2018.
~Of the 36 patients attending Visit 1, 30 were eligible for Calcivis imaging ( 3 patients were pregnant, 2 patients had appliances on less than 12 months and I patient did not have visible white spot lesions)."|
718235|NCT02771366||Within subject design, total N = 30. Participants complete both arms.
718236|NCT02771340||
718237|NCT02771275||
718238|NCT02771145|Subjects were recruited from 6 study centers located in Japan.|Of the 91 enrolled, 1 subject was exited as a screen failure prior to treatment. This reporting group includes all treated subjects (90).
718239|NCT02771093|Participants took part in the study at 2 investigative sites in Japan, from 08 September 2016 to 27 April 2017.|Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in 1 of 2 (the trelagliptin 100 mg group or the alogliptin 25 mg group) treatment groups.
718240|NCT02770846||
722877|NCT02330523|Patients were recruited at all 9 investigation sites between October 2013 and June 2014.|
722878|NCT02330341||
718244|NCT02770521|This study had two parts: Part A was a two-period crossover. Part B was a three-period crossover with dose escalation. Healthy Japanese participants were eligible to enroll in one part. One randomized participant discontinued prior to study completion and was replaced. The replacement adopted the original participant's randomization scheme.|
718245|NCT02770365||
718246|NCT02770287|Single center, baseline-controlled, open-label study. First subject enrolled March 26, 2016 and last subject completed the study on June 28, 2016.|
718247|NCT02770248|Subjects were recruited from 16 study centers located in the United States.|Of the 162 enrolled, 37 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (125).
718248|NCT02770014||
718249|NCT02769858||
718250|NCT02769702||
718251|NCT02769624|This was a randomized, placebo-controlled, double-blind, crossover trial conducted at one center. Healthy Fontan patients were recruited from within the medical center's Fontan management program for participation in this trial. Each patient completed three study visits over the course of six weeks.|Each participant came in for a baseline visit initially and then for the second visit, they were randomly assigned to receiving either the study medication or placebo. At the third visit, the patient received the opposite of what they received at visit two.
718252|NCT02769442||
718253|NCT02769312|"Participants consented at a formal in-person eligibility determination (screening).
~Location: Providence, RI"|"6 participants were excluded during pre-assignment.
~2 Not Eligible (1 due to the absence of Criterion A trauma, 1 declined to complete eligibility procedures)
~2 Withdrew Consent
~2 Discontinued (1 lost/unable to contact, 1 inpatient admission)"
718254|NCT02769247||
718255|NCT02769065|Participants took part in the study at 1 investigative site in United States from 05 May 2016 to 08 June 2017.|Healthy participants (non-Japanese and Japanese) and participants with mild cognitive impairment (MCI) or mild Alzheimer disease (AD) (non-Japanese) were enrolled in cohorts: TAK-071 single-rising-dose (SRD), multiple-rising dose (MRD), Food Effect Crossover or in combination with donepezil.
718256|NCT02768870||
718257|NCT02768753||
718258|NCT02768558||Registered patients who submitted tissue for PD-L1 assessment and had no evidence of distant metastases or local disease progression at the second step registration were randomized. Of 20 registered patients, 8 were randomized.
718259|NCT02768298|Participants took part in 34 investigative sites in Germany.|Participants were randomized 1:1 to receive either LCZ696 or enalapril during the double-blind period.
718260|NCT02768194|Participants were recruited at one center at United Kingdom.|A total of 26 participants were screened, out of which 24 participants were randomized to the study and 2 participants withdrawn their consent.
718261|NCT02768129||Of the 30 participants that were consented, 9 participants were ineligible, withdrew, or were lost to contact before commencing tDCS.
718262|NCT02768103||
718263|NCT02767947||A total of 75 participants with tinea corporis were enrolled and randomized in 4:1 ratio to receive either luliconazole cream 1% or vehicle cream.
718264|NCT02767934||
718265|NCT02767869||
718266|NCT02767843||
718267|NCT02767765||
718268|NCT02767609||
718269|NCT02767531|"A randomized,open-label, crossover trial with four periods and two sequences (orlistat and off for 3 months each) was conducted."|
718270|NCT02767427||
718271|NCT02767388||
718272|NCT02767271||
718273|NCT02767128||
718274|NCT02767011||
718275|NCT02766907||
718276|NCT02766777||
718277|NCT02766673||The original study sample size called for 25 subjects. The block randomization scheme of 6 treatment sequences within 1 randomization block. Therefore we recruited 24 patients to complete 4 randomization block. the 25th patient would have started a new randomization block and make one treatment sequence more common that the others.
718278|NCT02766608|This study randomized subjects at 244 study centers in 7 countries, from June 2016 and November 2017. The study period was scheduled to take up to approximately 30 weeks for each individual subject from the time of screening through the follow-up period.|Subjects were randomized in a 3:3:3:1:1 ratio to BFF 320/9.6, BFF 160/9.6, FF 9.6, BD 320, and Symbicort.
718279|NCT02766517||Participants with migraine who had previously participated in the Phase 2 galcanezumab study, NCT02163993 [I5Q-MC-CGAB], and received either 120 milligram (mg) or 300 mg galcanezumab or placebo, with suitable skin characteristics for the dermal capsaicin challenge, were included in the I5Q-MC-S001 (NCT02766517) trial.
718280|NCT02766400|Recruitment period: August 2012 to December 2014. Participants with acute stroke were enrolled in inpatient rehabilitation at Mercy and Montefiore Hospital.|"Excluded (n=27)
~Insufficient cognitive impairment (n=6)
~Mood/psychotic disorder (n=14)
~Drug/alcohol abuse (n=3)
~Change in medical status (n=1)
~Pre-morbid cognitive impairment (n=1)
~Short Length of Stay (n=2)
~Withdrew prior to randomization (n=7)
~Changed mind (n=4)
~Discharged (n=3)"
718281|NCT02766374||
718282|NCT02766283|This study was a retrospective cohort study, using the data from the years 1998 until 2015 in the database of Maccabi Health Services (Israel).|Between 1.1.1998 and 31.12.2015, 877 participants were identified. After applying exclusion criteria, 34 participants were excluded from the initial cohort and the final cohort consisted of 843 participants.
718283|NCT02766244||
718284|NCT02766088|In December 2017, GSK decided to deprioritize the development of the dengue purified inactivated vaccine (DPIV) candidate. This decision was made due to the significant scientific challenges of dengue vaccine development. Hence, only 2 sites participated to the study, 1 in Mexico and 1 in Philippines.|
718285|NCT02766023|Participants were non-pregnant females with untreated bacterial vaginosis recruited from the clinics conducting the study and from other clinical providers coordinating referrals of eligible women to the study centers. Participants were enrolled between 03JUN2016 and 27AUG2018.|
718286|NCT02765490||
718287|NCT02765269||
718288|NCT02765100||
718289|NCT02764970||
718290|NCT02764775||
718519|NCT02738879|A total of 746 participants were randomized across 149 study sites in 22 countries.|Male and female participants with Type 2 diabetes mellitus (T2DM) ≥18 years of age were enrolled in this trial.
718291|NCT02764697|"The recruitment period was 06/31/2016 through 08/10/2016
~Active follow-up period 06/31/2016 through 12/07/2016
~The study was conducted at 1 site Tampa Bay Uveitis Center, LLC 5800 49th Street North, St Petersburg Fl 33709: Outpatient Medical Clinic"|The patient after consent was given, were required to have their medical records reviewed and have screening laboratory evaluations
718292|NCT02764229|Participants were enrolled at 40 study centers with the United States, Poland, Hungary, Czech Republic, Serbia and Netherlands. Study centers included academic medical centers and non-academic medical clinics.|Eligible subjects were those completing the preceding double-blind study LYC-30937-2001 Week 8 visit.
718293|NCT02764190||
718294|NCT02764164||
718295|NCT02764151||After reviewing efficacy, safety, PK and PD of all available data from enrolled patients, the Sponsor decided to prematurely terminate the study and not to pursue marketing approval for PF-06840003 in the indication of malignant glioma. Part 2 of the study was not initiated.
718296|NCT02763865|clinic|screening procedures per inclusion and exclusion criteria, no wash out, stayed on meds.
718297|NCT02763644|Due to low confidence of clinical benefit, this study was closed. In the beginning 3 participants were assigned to LFG316 on top of SoC & 4 subjects to only SoC (so total 7 randomized). 2 were randomized to SoC switched arm to LFG316 plus SoC. This means that 2 SoC and 2 in SoC then LFG316 are the same subjects as All SOC first.|
718298|NCT02763579||Participants in this study included: extensive-stage small cell lung cancer (ES-SCLC) with no prior systemic treatment for ES-SCLC.
718299|NCT02763566||Participants who died due to any cause or disease progression or alive and on study at conclusion but off treatment are considered as completed.
718300|NCT02763254|Study was closed early due to inadequate recruitment.|
718301|NCT02763215||
718302|NCT02763189||
718303|NCT02763124||
718304|NCT02763046|Participants took part in 40 investigative sites in Germany.|Participants were randomized 1:1:1 to one of the following treatment groups: secukinumab 150 mg s.c. with delayed NSAID tapering, secukinumab 150 mg s.c. with early NSAID tapering and placebo.
718305|NCT02762877||
718306|NCT02762799||
718307|NCT02762578|A total of 41 sites were approved for recruiting subjects, of which 40 sites screened and randomized the subjects.|Insulin treated subjects on current treatment: basal insulin, premixed insulin or a self-mixed insulin regimen, all administered once daily or twice daily (BID) with or without metformin. The treatment regimen should have remained unchanged for at least 8 weeks prior to randomisation.
718308|NCT02762500|Participants were enrolled at 42 study centers within the United States, Poland, Hungary, Czech Republic, Serbia and Netherlands. Study centers included academic medical centers and non-academic medical clinics.|Participants were 18 to 75 years of age with active ulcerative colitis for at least 6 months prior to screening, had a total Mayo score (TMS) ≥ 4 to ≤ 11, with endoscopic subscore ≥ 2, and rectal bleeding subscore ≥ 1 at screening.
718309|NCT02762370|Patients were screened for study eligibility at 9 study centers in the United States (US).|Patients were Randomized within 21 days of Screening.
718310|NCT02762331||
718311|NCT02762084||
718312|NCT02762071||
718313|NCT02761980||In this study, participants were administered at least 1 test dose of reference standard endotoxin (RSE) intravenously, based on their body weight before randomization, to induce pyrexia in them.
718314|NCT02761967||
718315|NCT02761733|The research team distributed recruitment letters (in English and Chinese) via mail and in person in all four research sites. With assistance from case managers, research assistants introduced themselves to patients and invited participation. Recruitment occurred from October 2013 to June 2014.|Enrollment was not directly related to the assignment of intervention, which was randomized at the site level. The screening predetermined criteria (exclusion of cognitive impairment). The number of individuals found eligible to participate was 266, and the research team subsequently randomly selected 240 participants.
718316|NCT02761642||
718317|NCT02761629||
718318|NCT02761252|"The recruitment started on 13 April 2016 and termineted on 23 November 2016. 454 patients with SARC and mild to moderate asthma as comorbidity were screened.
~420 patients were randomised of which 388 patients completed the study."|454 patients were enrolled but 34 patients did not met inclusion/exclusion critera.
718319|NCT02760927||
718320|NCT02760862||
718321|NCT02760810||A total of 31 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 30 were dispensed the study lens. Of the dispensed subjects 29 completed the study and 1 subject was discontinued from the study.
718322|NCT02760654||
718323|NCT02760602||Participants were randomized by site and by use of florbetapir positron emission tomography (PET) scanning or cerebrospinal fluid (CSF) for study eligibility.
718324|NCT02760368|Enrollment was conducted at 42 clinical sites (in Belarus, Bulgaria, Russia,Turkey) between May 2016 and April 2018. 785 patients were included, 357 patients screen- failured, 428 patients were randomized (143 patients in OKZ q2w +MTX group, 142 patients in OKZ q4w +MTX group, 143 patients in Placebo q2w +MTX group). 427 patients were treated.|
718325|NCT02760277||
718326|NCT02760264||
718327|NCT02760069||
718328|NCT02760056||
718329|NCT02759939|The recruitment period was April 1, 2016 to December 30, 2016. Recruitment took place in 16 primary care and/or reproductive health care clinics in the Northeast United States.|This was a cluster randomized trial. The level of randomization was clinics.
718330|NCT02759692||A total of 283 subjects were enrolled into this study. Of the enrolled subjects all were dispensed at least one study lens. Of the dispensed subjects 276 subjects completed the study and 7 subjects were discontinued.
718331|NCT02759562|Participants were enrolled at study sites in Australia and Europe. The first participant was screened on 04 November 2016. The last study visit occurred on 21 July 2017. The study was terminated after 6 participants were enrolled in Part 1 of the study. Therefore, Part 2 was not initiated.|26 participants were screened.
718332|NCT02759471||
718520|NCT02738853||
718521|NCT02738801||
718522|NCT02738580||
722879|NCT02330276||
722880|NCT02330172||
722881|NCT02330094||
718333|NCT02759354|This multicenter extension study was conducted in Finland at approximately 10 sites from studies V419-007 and V419-008, which had eligible participants(i.e. participants who completed the full 3+1 or 2+1 vaccination schedule in the original studies).|Of the 760 screened participants, 754 were enrolled and completed the study. A total of 752 participants were included in the Persistence Analysis Set, 752 with blood samples available for hepatitis B surface antigen (HBsAg) analyses, and 751 for pertussis analyses.
718334|NCT02759315|Adult participants with hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, or 6 infection were enrolled at 5 study centers in the United States. Participants with HCV GT5 infection were initially intended for inclusion but none were enrolled.|
718335|NCT02759146|Participants were recruited from 8 clinical centers between April 2015 and November 2019.|"Of the 471 consented, 347 completed the baseline interview and were randomized. Between the time of consent and baseline interview 124 dyads attrited. Reasons included:
~Changed mind about participating (n=24), cannot be reached via phone/mail (n=55), too busy (n=19), too overwhelmed (n=8), too sick (n=9) and other reasons (n=48).
~Throughout the study, if either patient or caregiver dropped from the study, the dyad was considered an attrition."
718336|NCT02759016|This trial was planned to consist of 2 parts. First part was a Phase Ib, open-label, single arm, multi-center, dose escalation trial to determine the maximum tolerated dose and the recommended Phase II dose of intravenous BI 836826 in combination with ibrutinib. Original protocol planned a Phase II part which was not conducted.|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that the subjects strictly met all inclusion and none of the exclusion criteria. Abbreviations: SD=Stable Disease, PR-MRDpos=Minimal Residual Disease positive Partial Response, PR-L=Partial Response with Lymphocytosis.
718337|NCT02758899||
718338|NCT02758717||
718339|NCT02758613||
718340|NCT02758301||
718341|NCT02758210|Participants were recruited from those already participating in the MICRA Study and MICRA CA Study at Emory University Hospital and Emory University Hospital Midtown. Participants for this substudy were enrolled between April 2016 and October 2016.|
718342|NCT02758171||
718343|NCT02758132||
718344|NCT02758119||
718345|NCT02757963|A total of 1658 male participants, >=50 years of age, with reasons not related to lower urinary tract symptoms (LUTS) were included in evaluable Population. The study was conducted at 47 centers in 5 countries; 8 centers in France, 9 centers in Germany, 6 centers in Italy, 18 centers in Russia and 6 centers in Spain.|A total of 2343 male participants were screened for probable Benign prostatic hyperplasia (BPH). Of these, 1679 participants were enrolled, 1658 participants were included in the evaluable population. 21 participants progressed in the study but were found to have not met eligibility criteria. Overall, 561 participants completed all 3 visits.
718346|NCT02757950|A total of 2462 subjects were enrolled in the study in one center in Brazil.|
718347|NCT02757768|The study enrolled male participants with overactive bladder (OAB) symptoms who were taking the alpha-blocker tamsulosin for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).|Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled. Participants entered a 4-week open label tamsulosin hydrochloride 0.4 mg once daily (QD) run-in period prior to being randomized in a 1:1 ratio into the 12-week double-blind treatment period of either mirabegron or placebo once daily.
718348|NCT02757625||
718349|NCT02757547||Subjects participating in the study will undergo both arms. Subjects will first complete the Placebo Arm and then will complete the Active Arm.
718350|NCT02757521||
718351|NCT02757430|Any patient indicated to undergo a cardiac electrophysiology (EP) mapping and ablation procedure that used the EnSite Precision™ Cardiac Mapping System was considered eligible.|
718352|NCT02757352|This study has 3 periods: Period 1 - Screening; Period 2 - A Double-Blind Treatment Period (Weeks 0 Up to 52); (Inadequate Responders [IR] Week 16-52) followed by a Follow-Up Period (Up to 24 Weeks after last visit)|Participants who completed study were eligible to enroll into a long-term study (Study I1F-MC-RHBY [RHBY]) for up to 2 additional years. Participants that do not enroll into study RHBY will complete the Post-Treatment Follow-Up Period.
718353|NCT02757105||
718354|NCT02757092|The study was design a Prospective randomized control trial,and enrolled a total of 36 older patients with lung tumors after thoracoscopic surgery in the cardiothoracic and vascular ordinary ward between March 31 2016 to April 1 2017. The study was performed conducted in Kaohsiung Chang Gung Memorial Hospital, Taiwan|
718355|NCT02757053||Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination.
718356|NCT02756949|Participants were recruited at 5 public HIV testing sites (1 community health center, 3 clinics, and 1 tertiary hospital) in inner city Johannesburg, South Africa. Recruitment happened from October 2015 to June 2016. HIV positive individuals were pre-screened for trial suitability and recruited if eligible upon screening.|Of the 4537 individuals approached about the study, 90 declined to participate and 4094 were found ineligible during pre-screening and screening, leaving 353 for randomization. 8 standard of care arm participants were later removed from analysis due to erroneous sending of SMS reminders for their 6-month clinic appointment leaving 345 for analysis.
718357|NCT02756832|Participants took part in the study in Russia from 20-Sep-2016 to 28-Apr-2018.|Participants with a diagnosis of diabetes mellitus type 2 (T2DM) prescribed alogliptin benzoate in accordance with Russian SmPC were enrolled in this observational study.
718358|NCT02756819|Participants took part at 65 sites in the study in Russian Federation and the Republic of Kazakhstan from 18-Jul-2016 to 08-May-2018.|Participants with a diagnosis of hypertension and who were obese, prescribed azilsartan medoxomil in accordance with local summary of product characteristics (SmPC) were enrolled in this observational study.
718359|NCT02756689|One additional patient was already scheduled to participate when the study met the projected number (128). The final (#129 patient) was offered participation in the study since she had already been scheduled for a study visit and possible induction of labor.|
718421|NCT02750501|Recruitment was conducted through Cystic Fibrosis Care Centers.|"7-day Observation Period: Maintain usual enteral feeding (EF) regimen. 7-day Run-in period: Maintain usual EF volume up to a max of 1000 mL using standard formula for at least 5 days.
~49 subjects signed consent; 5 screen failed; 44 started the observation period; 39 completed observation and run-in periods entering the treatment period."
718360|NCT02756650|8 subjects enrolled 5 subjects were evaluated in Rheumatology clinic. 3 subjects were evaluated in Neurology clinic.|Ten patients were planned to be enrolled. Nine patients were screened. Eight patients were enrolled. Six patients completed the study. One patient was dropped out in the 7th visit because of an unknown drug abuse. One patient was dropped out in the 11th visit because of adverse event, worsening in pulmonary artery aneurysm.
718361|NCT02756637||
718362|NCT02756624|Subjects were recruited from six sites in the US.|There were 516 subjects enrolled, 23 subjects discontinued, and 493 subjects completed the study. Participant flow and baseline characteristics are presented for the 516 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 Vehicle.
718363|NCT02756611|Participants were enrolled at 59 sites in 19 countries. This study is currently ongoing. Results are reported up to the primary analysis data cut-off date of 30 June 2019, which occurred after all participants completed the Week 48 disease assessment.|
718364|NCT02756364|Participants took part in the study at 50 investigative sites in Spain and the United States from 28 July 2016 to 25 November 2019. After all data was collected and participants were transitioned to post-trial access, the Sponsor stopped the study site, defined as 'Site terminated by the Sponsor'.|Female participants with a diagnosis of estrogen receptor (ER)-positive/human epidermal growth factor receptor-2 (HER2)-negative advanced or metastatic breast cancer that has progressed during or after aromatase inhibitor therapy were enrolled in 1:1:1 ratio to receive fulvestrant, fulvestrant + sapanisertib QD and fulvestrant + sapanisertib QW.
718365|NCT02756351||
718366|NCT02756338||
718367|NCT02756182||
718368|NCT02756078|A total of 200 subjects were enrolled into this study. Of the enrolled, 171 subjects were randomized and dispensed at least one study lens. Of the dispensed subjects, 127 completed the study while 44 subjects were discontinued.|
718369|NCT02756013||
718370|NCT02755935||
718371|NCT02755831|Enrollment. There were 714 women assessed for eligibility with N = 193 enrolled; n = 100 allocated to treatment group and n = 93 to the control group. In the treatment group there were n = 3 and n = 3 in the control group, respectively, loss to follow-up. The final analysis included n = 97 in the treatment group and n = 90 in the control group.|
718372|NCT02755818|Subjects are recruited from Sacramento areas within 50 miles radius, and University of California, Davis. Subjects of chronic kidney disease (CKD5) are recruited mainly from five DCI (Dialysis Clinic Incorporation) clinics in Sacramento area.|
718373|NCT02755805|Recruitment period: July 2009 to June 2012. Participants with acute stroke were enrolled in inpatient rehabilitation at Mercy and Montefiore Hospital.|"Excluded (n=30):
~Insufficient cognitive impairment (n=15)
~Mood/psychotic disorder (n=5)
~Aphasia (n=3)
~Recent drug/alcohol abuse (n=2)
~Primary diagnosis not stroke (n=2)
~Withdrew prior to randomization (n=3)
~Changed mind (n=1)
~Family reasons (n=1)
~Unexpected discharge (n=1)"
718374|NCT02755649|The study was conducted at 73 sites in Europe. A total of 390 participants were screened between 28 Jan 2016 and 14 Sep 2016. Of those, 325 participants were enrolled into the study and randomized. Sixty participants were considered screen failures, mostly due to unmet eligibility criteria.|After providing informed consent, participants were assessed for study eligibility. Screening assessments were performed between day -28 & day -15, prior to randomization. Participants who met eligibility criteria at baseline (day 1) were randomized in a 1:1:1 ratio to receive dupilumab (weekly [QW] or every 2 weeks [Q2W]) or placebo.
718375|NCT02755285|Subjects enrolled had been referred to Mayo Clinic for clinically indicated gastrointestinal diagnostic endoscopy between August 19, 2016 and September 7, 2016.|Each subject underwent a complete diagnostic endoscopy examination with white light, followed by an exam with BLI (BLI + BLI-brt) and FICE, at 3 FICE settings (1,2 & 6). Each subject could contribute up to 2 anatomical sites (regions of interest).
718376|NCT02755129||
718377|NCT02755116|180 patients consented, 36 excluded prior to study drug administration and 144 patients were randomized and enrolled.|
718378|NCT02755090||
718379|NCT02754674||
718380|NCT02754661||
718381|NCT02754570||
718382|NCT02754492|"A participant was considered enrolled upon signing the informed consent form."|"334 participants consented/enrolled: 19 screen-failed; 5 never started procedure = 24 participants excluded from Safety Analysis.
~310 participants = Safety Analysis set (31 participants excluded from the full analysis set: 23 of these participants were unassigned to an Arm, 8 participants were assigned to an Arm)
~279 = Full Analysis set"
718383|NCT02754440|"A participant was considered enrolled upon signing the informed consent form."|"365 participants consented/enrolled: 25 screen-failed; 5 never started procedure = 30 participants excluded from Safety Analysis.
~335 participants = Safety Analysis set (56 participants excluded from the full analysis set: 35 participants were unassigned to an Arm, 21 participants were assigned to an Arm)
~279 = Full Analysis set"
718384|NCT02754427||
718385|NCT02754310||
718386|NCT02753946|"Patients diagnosed with cUTI/AP based on signs and symtoms requiring 7 days hospitalization (or up to 14 days in case of bacteremia). No oral switch is allowed in the study.
~Confirmatory microbiology data only available after randomization."|At least 30% of patients required a diagnosis of AP. Receipt of effective systemic antibiotic for >24 hrs within 72-hr window before randomization exclusionary but receiving single dose of short-acting systemic antibiotic within 72 hrs of randomization permitted up to a max of 25% of the study enrollments.
718387|NCT02753920||After signing informed consent and enrolling in the study, 4 subjects withdrew consent prior to randomization, 4 subjects had surgery cancelled for various medical reasons, 3 subjects had cystotomies thus requiring prolonged catheterization for 1-2 weeks and 1 subject withdrew after randomization.
718388|NCT02753881||
718389|NCT02753842|Participants were recruited in Atlanta, GA from May 19, 2016 - May 2, 2017. Recruitment was predominantly through electronic advertising and paper signs posted at venues such as college campuses.|We recruited 504 participants into the crossover trial. Participants were randomized into one of six sequences, each representing the order in which a participant would receive batches of five study condoms of a particular type.
718390|NCT02753699|The study was conducted in 127 centers across 22 countries globally.|"Participants transferring from Study 2211 were allocated to the From Study 2211 group. These were evaluated as INF-free and Overall subgroups for efficacy analyses."
722882|NCT02330081||
718391|NCT02753595|Participants took part in the study at 4 investigative sites in the United States from 13 Jul 2016 to 16 Aug 2019. A total of 25 participants were screened and enrolled (signed informed consent form), of which 11 were screen failures, and 14 were treated.|Study terminated early during Phase 1b Expansion Part and before initiating Phase 2 due to poor accrual. Data reported is based on initial dosing levels given to participants during Phase 1b. Combined data for participants who received Dose level 0 during determination of RP2D and confirmation of RP2D (Expansion Part) are reported as planned.
718392|NCT02753413|A total of 102 subject numbers were screened, but only 100 subjects were randomized and received vaccination.|
718393|NCT02753075||A total of 283 participants were screened, out of which 240 participants were randomized.
718394|NCT02752958|This study had 2 centers in United Kingdom (UK) but, all the participants were recruited from the 1 center only.|A total of 163 participants were screened, of which 75 participants were enrolled and randomized in the study. A total of 88 participants were not randomized in study as 53 participants did not meet study criteria, 1 participant had adverse event (AE), 3 were lost to follow up, 6 had protocol violation and 25 due to other reason (not specified).
718395|NCT02752906|Study participants were enrolled in 30 centers from 15 April 2016 to 02 August 2016.|A total of 810 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study.
718396|NCT02752880||
718397|NCT02752802||
718398|NCT02752776|A total of 1660 participants were treated and included in the Safety set.|A total of 1858 patients were screened in this study.
718399|NCT02752633||
718400|NCT02752490||
718401|NCT02752256||
718402|NCT02752087|This was a four-period crossover study of U-193 LY900014 test formulation and U-95 LY900014 reference formulation with a minimum of 3 days between dosing.|
718403|NCT02752074|This study was conducted at 135 centers in 23 countries|
718404|NCT02752048||
718405|NCT02751983|"6 participants (1 Treatment as Usual (TAU), 5 TAU plus ACT (ACT)), were enrolled in a pilot to the pilot phase of the current study. Clinicians were trained based on the first 5 ACT participants and qualitative feedback was used to revise the ACT for Life manual prior to enrolling an additional 70 participants who were randomized to ACT or TAU."|
718406|NCT02751931|Pediatric participants consisting of male and female children from 3 to <12 years of age and adolescents from 12 to <18 years of age, with a body weight of >=11 kilogram (kg), with Neurogenic detrusor overactivity (NDO) on clean intermittent catheterization (CIC) were enrolled in this study.|Eligible participants who met inclusion and none of the exclusion criteria were enrolled. Participants who received oral drug to manage their NDO completed a 2 week washout period. A total of 113 pediatric participants were screened, 22 of whom were screening failures.
718407|NCT02751879|This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® tablet once daily as indicated in the approved labels. Between December 2016 and October 2017, 231 patients were screened for study participation and 228 patients were treated.|All patients were screened for eligibility to participate in the study. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to study if any of the specific entry criteria were violated.
718408|NCT02751580||
718409|NCT02751450|Participants were recruited at one center in United Kingdom.|A total of 263 participants were screened, 233 were randomized and 232 completed the study. One participant withdrew from study due to adverse event (AE).
718410|NCT02751424|This is a first-time-in-human (FTIH), randomized, double-blind, placebo-controlled, dose-escalation study to determine the safety, tolerability & pharmacokinetic (PK) profile of GSK3342830 after administration of single (Part 1) & repeat (Part 2) IV doses in healthy adult participants (par.) & single IV dose in healthy adult Japanese par. (Part 3).|A total of 62 par. were enrolled in the study. Part 1 comprised of 48 par. and 14 par. were enrolled in Part 2. No par. were enrolled in Part 3 as the study was terminated early per sponsor discretion.
718411|NCT02751385|Phase I study to investigate the effect of multiple oral doses of nintedanib on the single dose kinetics of a combination of ethinylestradiol and levonorgestrel (Microgynon®) in patients with non-small cell lung cancer.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all subjects met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
718412|NCT02751320|Participants were recruited at one center in United States.|A total of 58 participants were screened, of which 45 participants were randomized and 42 completed the study.
718413|NCT02750943|Participants were recruited in a single center in Germany.|A total of 317 participants were screened. Out of which only 253 participants were randomized.
718414|NCT02750930|A total of 8 participants with Diabetes Mellitus type II, were enrolled in the study from 3 centres in United States of America. The study was conducted from 07 October 2016 to 21 March 2017. The study was terminated prematurely as a reflection of GlaxoSmithKline business considerations.|The participants who completed study 200952 and who were eligible, were included in this open-label extension study 204682. This was an extension study, hence visit 1 of this study was also a last treatment visit of study 200952 (NCT02683746).
718415|NCT02750813|Subjects were recruited from 12 study centers located in the United States.|Of the 252 enrolled, 5 subjects were exited prior to randomization and 1 randomized subject was exited prior to treatment. This reporting group includes all randomized subjects who were exposed to a study product (test or control) (246).
718416|NCT02750800||Full Analysis Set: participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of adalimumab
718417|NCT02750761||Prior to enrollment, participants were receiving prophylaxis for or with a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram-positive antibacterial activity.
718418|NCT02750709||
718419|NCT02750618||The study enrolled pediatric participants between 1 and 4 years old, inclusive, with clinical findings consistent with XLH including hypophosphatemia and radiographic evidence of rickets, and a confirmed PHEX mutation or variant of uncertain significance.
718420|NCT02750592|A total of 37 patients were screened, and 30 patients (81.1%) completed the screening phase and entered Treatment Period|Seven patients were screening failures
718436|NCT02748512|One subject was assigned to the Mk II; however, received treatment with the Mk I after attempted to use 2 different Mk II inserters without success and switched to the Mk I inserter. The data for this subject were included in the Mk II inserter treatment group for ITT population and in the Mk I inserter treatment group for the safety population|Prior to analysis no Subjects were Excluded From the Utilization Analysis (i.e., completed Day 7). 1 MKI and 1 MKII eyes were lost to follow-up at Month 12.
718437|NCT02748356||
718438|NCT02748317|Participants were recruited nationwide between Jan 20, 2016, and May 31, 2017|
718439|NCT02748213||
718440|NCT02748070||
718441|NCT02748057||
718442|NCT02747628||
718443|NCT02747615||
718444|NCT02747433||Of the eleven individuals enrolled, one did not meet inclusion criteria and ten were randomized to treatment.
718445|NCT02747186||
718446|NCT02747108|Veterans that met preliminary study eligibility criteria were mailed a letter about the study and were contacted by a Research Assistant 10 days later by phone to gauge their participation interest. Recruitment was conducted between December 2015 and February 2017.|Participants that met study criteria and had an upcoming primary care appointment were sent a Baseline Survey to complete as a requirement for randomization. Those that did not complete the Baseline Survey or whose primary care appointments were cancelled and not rescheduled were not randomized and thus excluded from analysis.
718447|NCT02747043|A total of 380 subjects were screened and 256 participants (128 in the ABP 798 treatment group and 128 in the rituximab treatment group) were randomized at 91 centers across 20 countries.|Participants were randomized centrally to receive either ABP 798 or rituximab in a 1:1 manner. The randomization was stratified based on geographic region (Europe, Americas, Japan, Asia Pacific - Other) and age group (> 60 years of age, ≤ 60 years of age).
718448|NCT02747004||
718449|NCT02746991||
718450|NCT02746809||
718451|NCT02746705||
718452|NCT02746679|Patients were recruited into present study between January 2015 and January 2016|A total of 226 patients with IUA were recruited into present study within 12 months. Of them, 10 met the exclusion criteria and 55 patients refused to participate in this study. Finally, 161 patients were randomized into MBSR group (n=80) and wait-list group (n=81).
718453|NCT02746627||
718454|NCT02746575||
718455|NCT02746406||
718456|NCT02746263||
718457|NCT02746107||
718458|NCT02745626|Recruitment period: December 2011 - March 2014. Location: Orthodontic Clinic, School of Dental Medicine, University of Connecticut Health, Farmington , CT|
718459|NCT02745535|Study enrollment opened 5-May-2016 and closed 24-Jan-2018. All study visits were done in an outpatient medical clinic in Baltimore or Washington DC.|Participants infected with chronic hepatitis C (HCV), genotype 1, who previously were treated with unsuccessful combination DAA-based therapy were enrolled in the study. Subjects included HCV mono-infection, HCV/HIV co-infection or HCV/hepatitis B (HBV) co-infection or HCV/HIV/HBV triple-infected patients.
718460|NCT02745392||
718461|NCT02745353||
718462|NCT02745210|Participants were recruited from medical, surgical, or neurological services of LLUMC. Non-injured participants were recruited from MRI staff, Loma Linda University student or Resident populations|
718463|NCT02745145||The study enrolled 24 participants and was early terminated due to the difficulties experienced in identifying participants who meet the eligibility criteria of the trial.
718464|NCT02745119|"994 participants enrolled in study . study terminated early by Sponsor due to lack of efficacy.
~842 patients received at least one lampalizumab injection 152 patients enrolled in Study GX30191 did not receive study drug in the extension study and thus were excluded from the safety-evaluable population."|Eligible participants were those who enrolled in Studies GX29176 (NCT02247479) and GX29185 (NCT02247531) and had completed the 96-week treatment period without early treatment discontinuation or study discontinuation.
718465|NCT02744898||
718466|NCT02744846||
718467|NCT02744755|353 patients were randomized (1:1)and received at least one dose of study drug; 303 patients completed the study.Eligible patients in the Humira group who completed Study Period 1 (baseline to week 24) with an at least moderate response by DAS28-CRP score were switched to GP2017 treatment during Study Period 2 (Week 24 to week 48).|Full analysis set: randomized patients (study drug assigned) Per protocol set study period 1 (SP1) / study period 2(SP2): patients who completed Week 12 (SP1) / Week 48 (SP2) without major protocol deviations and received at least 5 doses of study drug up to Week 10 (SP1) / 10 doses of IMP from Week 24 to Week 46 (SP2)
718468|NCT02744534|Participants were recruited from Emory University Hospital and the Winship Cancer Institute in Atlanta, Georgia from November 2015 to April 2017. All study procedures were completed by March 31, 2018.|Participants with abnormal anti-1-amino-3-[18F]fluorocyclobutane-1- carboxylic acid (FACBC) positron emission tomography (PET)-CT scans were to have both targeted and template biopsies while those with normal FACBC PET-CT scans would have only the standard of care template biopsy. None of the study participants had a normal FACBC PET-CT scan.
718469|NCT02744391||
718470|NCT02744352||
718471|NCT02744066|Patients were recruited from admissions to the neonatal intensive care unit (NICU) in two phases. In phase #1 of the study 25 infants were recruited for participation and 25 infants completed the protocol. In phase #2 of the study 30 additional infants were recruited, with 25 infants completing the protocol. The total number studied was 50.|
718472|NCT02743962|Urology and Urogynaecology consultants' secretaries identified potential participants using a range of keywords and International Classification of Diseases (ICD-10) codes in April 2016. Potential participants attended a meeting at a single private hospital site and recruitment was completed by the end of May 2016.|There was no pre-participation period. Once consented to participate participants began the study.
718473|NCT02743949|Participants took part in the study at 33 investigative sites in Belgium, Bulgaria, Czech Republic, Estonia, Poland and United Kingdom from 14 July 2016 to 12 October 2018.|Participants with a symptomatic gastro-esophageal reflux disease who have a partial response following treatment with a high dose of proton pump inhibitor were enrolled in a 1:1:1 ratio to receive esomeprazole 40 mg, vonoprazan 20 mg, or vonoprazan 40 mg.
718474|NCT02743936||
722883|NCT02330055||
732726|NCT01614899||
732727|NCT01614886||
718475|NCT02743780|Subjects were recruited from 5 study centers located in the US.|This study was conducted in 3 parts. A separate cohort of subjects was enrolled for each part. Of the 191 subjects enrolled (Part 1, 2, and 3 combined), 79 were exited as screen failures and 14 were discontinued prior to randomization. This reporting group includes all randomized subjects. A zero indicates no intended subjects.
718476|NCT02743702||
718477|NCT02743520||
718478|NCT02743377||16 subjects were enrolled but one subject did not start the study.
718479|NCT02743312|5 volunteers were screened for eligibility from November 1, 2015, to April 1, 2016.|All 5 volunteers were enrolled.
718480|NCT02743221||154 patients were randomized among whom one was deemed ineligible after randomization.
718481|NCT02743117|A total of 301 participants were randomized and participated in the study from 02-May-2016 through 30-Nov-2016 at 3 sites in the United States of America (USA).|One participant was considered as screen failure and 300 randomized participants were treated in the study.
718482|NCT02743078||
718483|NCT02742987||
718484|NCT02742818||
718485|NCT02742766|A total of 104 participants (80 in Part 1 and 24 in Part 2) were randomized to receive either study medication or placebo. This study was conducted at a single center in Australia from 14-March-2016 to 16-June-2017.|This study was planned to be conducted in 3 parts: Part 1 (single-day dosing) and Part 2 (repeat dose) dose-rising study in healthy participants and Part 3 (repeat dose) in obese participants. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues.
718486|NCT02742649||
718487|NCT02742532||
718488|NCT02742519||Study consisted of 2 parts: Part 1- Double Blind (DB) Crossover Treatment Period and Part 2- Open Label (OL) Period.
718489|NCT02742441|"Recruitment period: June 2016 to February 2017
~The location of clinical sites included dermatology clinics and clinical research centers."|All subjects who met the entry criteria were randomized and enrolled into the study.
718490|NCT02742129|Patients with a diagnosis of HFpEF are screened for entry criteria. Willing participants meeting entry criteria will be consented and questioned to confirm that HF symptoms are the primary limitation to activity.|All consented participants continuing to meet the screening criteria will undergo a baseline HFN study-specific CPET to confirm Peak VO2 ≤75% with peak respiratory exchange ratio ≥ 1.0. All subjects that fulfill the CPET and other inclusion criteria and none of the exclusion criteria will be randomized.
718491|NCT02742103||To ensure that at least 1/3 of the study population had an estimated glomerular filtration (eGFR) in the chronic kidney disease (CKD) Stage 3b range, no more than 2/3 of the study population were to have an eGFR in the CKD Stage 3a range. Randomization was stratified by eGFR and by medical history of diabetes.
718492|NCT02742077||
718493|NCT02741713||
718494|NCT02741687|Participants were recruited from Emory University Hospital and Grady Hospital in Atlanta, Georgia between June 2016 and March 2017.|A total of 97 patients consented to be in the study and one participant withdrew prior to randomization. After subsequent failure to meet eligibility criteria (such as surgery being cancelled or postponed) and voluntary participant withdrawals prior to receiving the study medication there were 80 participants who received the study intervention.
718495|NCT02741635||
718496|NCT02741596|The study was conducted at 43 sites across United States, Canada, Europe and Jorden between 26 May 2016 (first participant first visit) and 31 October 2019 (last participant last visit).|A total of 212 participants were enrolled and received treatment in two groups (Rollover participants [109] and Non-rollover participants [103]). Participants who rolled from the DX-2930-03 (NCT02586805) study were in Rollover group and participants who were directly enrolled into this DX-2930-04 study were in Non-rollover group.
718497|NCT02741518||
718498|NCT02741310|This study was conducted at 1 center in Belgium; participants were enrolled from 22 February 2016 to 11 May 2016.|Eligible participants were randomized on day 1 to receive either erenumab or matching placebo in a 2:1 allocation ratio.
718499|NCT02741297||
718500|NCT02741284||
718501|NCT02741271||
718502|NCT02741245||
718503|NCT02741076|First Subject First Visit 14 September 2016; Date of Early Study Termination 29 January 2018|Prior to randomization, subjects gave consent and entered a pre-assignment period that assessed eligibility for the intervention phase of the study.
718504|NCT02740920||
718505|NCT02740660||
718506|NCT02740582||
718507|NCT02740413||The study was a retrospective population-based register study. Detailed data on each participant diagnosed with haemophilia was retrieved from the Malmö Haemophilia Register (MHR) in January 2016 covering the period of January 2005 up to December 2015.
718508|NCT02740049|Participant diagnosed with severe asthma were recruited from clinics at the Royal Brompton hospital between January 2016 and September 2016.|
718509|NCT02739997|Adult participants with complicated intra-abdominal infection (cIAI) were recruited at 37 study sites in Japan.|
718510|NCT02739984|Of 853 patients screened, a total of 424 participants were randomized at 58 centers in Belgium, Canada, Italy, Mexico, Poland, Spain and the United States from 17 May 2016 to 05 May 2017.|Participants received subcutaneous placebo during a 6-week screening period. Participants who completed the screening period and met final eligibility criteria were randomized in a 1:2 ratio to placebo or evolocumab. Randomization was stratified by low-density lipoprotein cholesterol (LDL-C) level (> or < 130 mg/dL).
718511|NCT02739828||
718512|NCT02739789||This was a within-subjects design, thus every subject received both active and sham conditions
718513|NCT02739698||43 subjects were recruited but 11 were excluded after the pathologist samples review
718514|NCT02739594||
718515|NCT02739360|Participants were enrolled at study sites in the Netherlands. The first participant was screened on 04 May 2016. The last study visit occurred on 28 December 2017.|Six participants previously enrolled in Study GS-US-315-0102 were offered screening for enrollment into this study.
718516|NCT02739321||Enrolled participants take part in a one-week lead in period during which time all participants sleep with the box spring foundation of the new mattress technology, but with the mattress technology turned off, and wear an actigraphy watch. Participants who are unable to tolerate the actigraphy watch or the box spring foundation are excluded.
718526|NCT02738151|The study was conducted at 158 study centers across 16 countries. A total of 1376 participants were screened between 19 May 2016 and 19 February 2017, of whom 447 were screen failures.|A total of 929 participants were randomized in 1:1 ratio to either Toujeo or Tresiba, stratified by screening glycated hemoglobin (HbA1c) values (<8% or >=8%); and use of sulfonylurea (SU) or meglitinides before the day of screening ('yes' versus 'no').
718527|NCT02738138||The study included a 35-day screening period.
718528|NCT02738086||
718529|NCT02738008|This study was conducted in participants who successfully completed the primary studies Heparc-2002 (NCT02604199) and Heparc-2003 (NCT02604212) through Day 113 and responded to therapy, except for those who achieved loss of Hepatitis B Surface Antigen (HBsAg) during the primary study.|No participants were enrolled from the Heparc-2002 or Heparc-2003 placebo groups.
718530|NCT02737917||
718531|NCT02737891||
718532|NCT02737852||
718533|NCT02737722||Overall, 48 participants were screened; 17 were screen failures and weren't enrolled. One participant was enrolled but not randomized.
718534|NCT02737631||
718535|NCT02737618||
718536|NCT02737592||
718537|NCT02737397||This was a 4 way cross-over study where 13 individuals received a single dose of an agent in a randomized sequence. All participants were intended to receive all four interventions.
718538|NCT02737358|Adult daily cigarette smokers were recruited from the community in Charleston, South Carolina (US).|Following screening, participants completed mobile daily diaries leading up to a Training visit. During this visit, participants were instructed on how to leave a carbon monoxide samples, upload videos, and loaned equipment to complete remote samples. Prior to randomization, 22 participants withdrew, were lost to follow-up or were discontinued.
718539|NCT02737332||
718540|NCT02737163||
718541|NCT02737072||This study was conducted in 2 parts. Phase 1a of the study consisted of a dose-escalation assessment and Phase 1b of the study included 2 expansion arms. The study was terminated after the Phase 1a part was complete. A participant completed the study if they completed at least 1 cycle.
718542|NCT02736955||
718543|NCT02736890||
718544|NCT02736825|The study was conducted at 8 sites in the United States.|A total of 262 participants were screened, enrolled, and treated in the study. Of these, 240 participants completed the 180-days evaluation. The study was terminated at 180 days.
718545|NCT02736721||
718546|NCT02736578||
718547|NCT02736188|143 participants were screened and enrolled across 14 total sites in the United States, Israel, United Kingdom, Italy, France, Canada, and Bulgaria. 87 participants rolled over from study UX001-CL301 (NCT02377921), 49 participants rolled over from study UX001-CL202 (NCT01830972), and 7 participants rolled over from UX001-CL203 (NCT02731690).|Of the143 participants who enrolled, 1 participant withdrew consent prior to receiving the first dose and is not included in the Safety Analysis Population presented below.
718548|NCT02736175||
718549|NCT02735980||
718550|NCT02735915|Subjects who participated in the parent study Zoster-003 (NCT00434577),in GSK1437173A _MD Group and received a complete vaccination course(2 doses of 50 µg GSK1437173A) were offered participation in this Long Term Follow-Up study. A total of 70 subjects met the eligibility criteria & consented to participate in Germany, Sweden and Czech Republic|Out of 70 subjects originally enrolled (Total enrolled cohort for persistence phase) into the study, 8 subjects were eliminated as subject number was allocated without vaccine administration. Only 62 subjects were vaccinated with at least one dose, forming the Total vaccinated cohort(TVc) for re-vaccination phase.
718551|NCT02735642|Participants were enrolled between May 2017 and April 2018 from three sites in Homa Bay County, Nyanza region, western Kenya. In fulfillment of Aim 1, we explored two recruitment approaches (homebased vs. mobile-event based) and three HIV testing options (oral self-test, staff-administered, or referral to health facility).|After participants completed HIV testing, only newly diagnosed participants living with HIV were enrolled into the SMART trial component of the study. This occurred from June 2017 to June 2018. Please note these are not additional participants, they are part of the N=1198 enrolled in the overall study.
718552|NCT02735577||
718553|NCT02735551||
718554|NCT02735421||A total of 67 Participants were randomized. All eligible participants had each half-face randomized to one of the two following treatments (with the other treatment applied to the other side of the face): adapalene 0.3% - benzoyl peroxide (BPO) 2.5% gel and adapalene 0.3% - BPO 2.5% vehicle gel.
718555|NCT02735382|This cluster randomized clinical trial was conducted in 23 primary care clinics, representing 2 health systems in Wisconsin, randomized to eReferral (intervention; n = 11) or Fax-to-Quit (usual care; n = 12). All participants were adult patients attending visits at their primary care clinics.|
718556|NCT02735200|Orthopedic clinics|consecutive patients
718557|NCT02735187|A total number of 51 patients were enrolled for the study at 1 study site in Germany between March and April 2016. 140 patients were pre-screened.|
718558|NCT02735174||
718559|NCT02735096|Single group, recruited at MU balance clinic|Patient with full denture was excluded
718560|NCT02735044|The study was conducted at 105 centers in 24 countries. A total of 616 participants were screened between 14 April 2016 and 31 October 2017, of which 153 were screen failures. Screen failures were mainly due to glycated hemoglobin (HbA1c) level outside of defined ranges per eligibility criteria.|A total of 463 participants were randomized in the study. Randomization was stratified by age group (<12 years and >=12 years) and by HbA1c (<8.5% and >=8.5%). Assignment to arms was done centrally using interactive voice system in 1:1 ratio.
718561|NCT02734953|Recruitment period: June 1-25, 2016 Recruitment Location: medical clinic|All enrolled participants were included,
718562|NCT02734940|The study was terminated because of lack of enrollment. No data was ever collected.|
718563|NCT02734862||
718564|NCT02734849|Date First Patient First Visit 04 April 2016 Date Last Patient Last Visit 05 January 2018 Date Enrollment was Terminated 31 May 2017|
718565|NCT02734810||
718566|NCT02734693||
718567|NCT02734498||
718788|NCT02710981||As this is a self controlled clinical trial, participants in the clomiphene citrate only arm (6th ovulation induction cycle) are the same participant in the clomiphene citrate plus sildenafil vaginal gel arm (7th ovulation induction cycle).
718568|NCT02734433|A total of 12 participants who met all inclusion and no exclusion criteria were enrolled in the study; 11 participants were treated.|The study was conducted in a dose-escalation 3 + 3 design and was comprised of 2 dose levels (Cohort 1 [600 mg/day] and Cohort 2 [1000 mg/day]). Selection of the pexidartinib dose of 1000 mg/day as the highest dose and the split-dose administration schedule was based on data from a Phase 1 study on patients with solid tumors (Study PLX108-01).
718569|NCT02734355||
718570|NCT02734238||Three participants discontinued the study during phase 1, prior to intervention assignment to a study arm: 1 was unable to tolerate study procedures and 2 had conflicting work/time commitments.
718571|NCT02734212||
718572|NCT02734056|Patients were consented prior to recruitment|
718573|NCT02733991||
718574|NCT02733757||
718575|NCT02733653||Sixty patients including 10 roll-in patients were enrolled in this trial. Roll-in patients are not included in the endpoint analyses.
718576|NCT02733588||A total of 8 patients were enrolled in the study. One subject withdrew prior to completing study procedures, leaving 7 subjects who were assigned to a treatment arm. Consistent with the number of subjects who started treatment period 1, the number enrolled is given as 7 even though demographics are presented for all 8 qualified/enrolled subjects.
718577|NCT02733367||
718578|NCT02733042|The study was conducted at 32 sites in 6 countries: France, Italy, Japan, the Netherlands, the United Kingdom, and the US. The study was to consist of 3 parts: dose-finding (Part 1) dose-confirmation (Part 2), and dose-expansion (Part 3). Part 3 was not opened. The study is ongoing; results are based on a data cut-off date of March 6, 2019.|Participants were assigned to 1 of 4 treatment arms based on the investigator's choice led by the participant's eligibility status per the inclusion/exclusion criteria for each treatment arm, prior antilymphoma/chronic lymphocytic leukemia (CLL) therapy, response to prior therapy, medical history, and the availability of open treatment slots.
718579|NCT02732951|This was randomised, double-blind, placebo-controlled, parallel-group trial to evaluate pharmacodynamics, safety and tolerability of orally administered Boehringer Ingelheim (BI) 1026706 for 12 weeks in patients with Diabetic Macular Oedema (DME).|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were violated.
718580|NCT02732938||Phase 2 part of the study was not conducted due to early termination.
718581|NCT02732912|Started 25 November 2016, Ended 13 February 2017 Recruited from medical and surgical wards in a large acute teaching and academic hospital in United Kingdom (UK)|
718582|NCT02732899||
718583|NCT02732639||
718584|NCT02732600|numbers of participants is presented at three time points: 1. Baseline 2. 6-months, and 3. 1-year|
718585|NCT02732587|Subjects were recruited online via craigslist.com and through local flyering|
718586|NCT02732561||
718587|NCT02732366|Participants were recruited from physician and physical therapist practices in a rural regional hospital. The intervention and control conditions were provided as 8-week programs. Recruitment was coordinated to occur approximately 4 weeks prior to a scheduled program/session, until sufficient numbers of participants were identified.|Two participants withdrew after consenting and before randomization. Note that randomization was done in session blocks.
718588|NCT02732327|The planned sample size was 100 patients; however, the sponsor discontinued the study due to the fact that the study no longer aligned with the revised clinical development plan and commercial strategy for CAZ-AVI. A total of 2 patients were enrolled and completed the study.|
718589|NCT02732210|The first participant was enrolled into the study on 6 July 2011 and enrollment continued until the 935th participant enrolled on the 5 April 2012. All participants were to be observed for at least 2 years, the last subjects last reported end date was 14 April 2014.|
718590|NCT02732145|"Patients were recruited at Poliklinika Harni, Zagreb, Croatia, during routine gynecological care, and from esthetic unit to obtain vulvar specimens from patients with the normal vulva.
~For each patient with vulvar dermatosis, the first consecutive patient with vulvodynia, impaired vulvar skin, and normal vulva was taken for comparison."|"Vulvar discomfort was evaluated with the ISSVD Vulvodynia Pattern Questionnaire (1. level of the investigation/pre-assignment), and vulvar lesions were assessed by clinical examination and Cotton-Swab test (2. level of the study/pre-assignment).
~Patients with vulvar infection and pre/malignancy were excluded from further investigation."
718591|NCT02731833|Participants were recruited at single clinical site in Canada.|A total of 229 participants were screened. Out of which 222 participants were randomized. 7 participants were not randomized because these participants did not meet study criteria.
718592|NCT02731820|Participants were recruited among the cohort of post-menopausal women attending to the Radiodiagnostic Unit of Istituto Ortopedico Rizzoli (IOR) from September 2015 to February 2017 to perform the periodic measurements of lumbar (at L2-L4 level) and femoral bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA).|
718593|NCT02731755||
718594|NCT02731742||The study was terminated prior to completion of Part A enrollment and prior to initiation of Parts B or C enrollment. This results disclosure is for Part A only.
718595|NCT02731690||
718596|NCT02731638||
718597|NCT02731469||
718598|NCT02731313||A total of 448 tumor specimens originating from 420 participants were assessed for inclusion in the study. Of these 448 specimens, 54 were excluded from analysis. 394 tumor specimen were included in the study which were derived from a population of 367 participants. This population (n=367) is reported in this study.
718599|NCT02731300|Study participants were recruited via advertisement at the pediatric outpatient department, Srinagarind hospital, Faculty of Medicine, Khon Kaen University, Thailand. A total of 22 patients with Lennox-Gastaut Syndrome (LGS) were enrolled between August 2010 and December 2013|All patients were assigned to record sizure frequency prior to start the protocol
718600|NCT02731157||
718601|NCT02731131||
718602|NCT02730988||
718603|NCT02730962||
718604|NCT02730884|Recruitment Period: August 2017 to April 2019|
718789|NCT02710890|The study started to enroll participants in May 2017 and concluded in June 2019.|Participant Flow refers to the Safety Set iv (SS-iv).
718790|NCT02710630||
718605|NCT02730871|Subjects were recruited from sites located in Argentina, Australia, Belgium, Chile, Columbia, Germany, Greece, Italy, Malaysia, Poland, Spain, Taiwan, and the United Kingdom.|Of the 173 enrolled, 39 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
718606|NCT02730819|Patients seen at the Mayo Clinic in Jacksonville, Florida between May 2016 and September 2016 were enrolled in the study.|
718607|NCT02730728||
718608|NCT02730663|It took about 15 months from the approval of the Ministry of Food and Drug Safety(MFDS) and the IRB, including the subject enrollment period of about 13 months and the follow-up period of 2 months at maximum.|
718609|NCT02730598||
718610|NCT02730455|Participants were recruited from 19 sites in Germany, 4 sites in the United Kingdom (UK), 12 sites in Spain, and 18 sites in the United States (US).|A total of 277 participants with acute ischemic stroke were randomized into the study (94 participants in the placebo group, 91 participants in the natalizumab 300 milligram (mg) group, and 92 participants in the natalizumab 600 mg group).
718611|NCT02730403||
718612|NCT02730377|The trial was conducted at 219 sites in Canada (11), Colombia (3), India (16), Latvia (2), Lebanon (4), Russian Federation (5), Serbia (6), Turkey (4) and the United States (168).|Participants were randomised in a 1:1 manner to receive either liraglutide or an oral antidiabetic drug (OAD) both as add-on to background therapy with metformin.
718613|NCT02730351|This was a multicenter, randomized, double-blind, double-dummy, crossover comparison study of fluticasone furoate (FF)/vilanterol (VI) versus fluticasone propionate (FP) in adolescent and adult participants with asthma and exercise-induced bronchoconstriction (EIB). The study was conducted in two countries-United States and Canada.|The study consisted of 4-week single-blind run-in, 2-week double-blind treatment period 1, 2-week single-blind wash out, 2-week double-blind treatment period 2 and 1-week Follow-up. A total of 163 participants were screened, 75 were randomized and 74 were included in Intent-To-Treat (ITT) Population who received at least 1 dose of trial medication.
718614|NCT02730260||"978 persons inquired about the program. 847 took steps to qualify for an employer health insurance discount Of these, 294 declined to enroll, e.g. for being in the precontemplative stage of change.
~553 persons participated in coaching. Of these, 35 worked with coaches in training. 518 participants enrolled in the randomized trial."
718615|NCT02730247||
718616|NCT02730208||A total of 41 participants were randomized and treated in the study.
718617|NCT02730195||
718618|NCT02730169||
718619|NCT02730130||
718620|NCT02729909|Participants took part in the study at 10 investigative sites in Mexico from 11 May 2016 to 05 June 2017.|Participants with a diagnosis of chronic idiopathic constipation were enrolled in a 1:1 ratio in one of two treatment groups to receive either lubiprostone 24 µg or placebo.
718621|NCT02729896|The study was conducted at 11 investigational centres in Germany (3), Poland (5) and USA (3).|
718622|NCT02729831|April 2016-December 2017. Adults diagnosed with hip or knee osteoarthritis who had a visit scheduled with a participating orthopedic surgeon at 3 sites were invited to participate before their visit.|Participants were randomized to a study arm after screening the surgeons' schedules. To be eligible for the study, patients needed to attend the visit with the surgeon. The majority of post randomization exclusions are due to patients not showing up to the visit. Some are due to limited clinical information available at screening.
718623|NCT02729753|Patients scheduled for esophagectomy for esophageal cancer or other indications unrelated to the objective of this study were approached to allow for use of cryoballoon ablation in area to be resected prior to surgery.|
718624|NCT02729545|Participants were recruited through advertisements on local newspapers and posters.Of the 116 individuals who were initially recruited for this trial, 56 were excluded,sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30).|
718625|NCT02729194||
718626|NCT02729051|This was a 24-week, randomized, double-blind, parallel group multicenter study to compare closed triple therapy Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) with open triple therapy (FF/VI + UMEC), in participants with chronic obstructive pulmonary disease (COPD). This study was conducted across 12 countries.|A total of 1311 participants were pre-screened, of which 1278 participants were screened (33 pre-screen failures). There were 175 screen failures and 48 Run-in failures. A total of 1055 participants were randomized and received the study treatment.
718627|NCT02729038|A 2-part study, conducted in participant's with varying degree of renal impairment (RI) which enrolled 32 participants, wherein, 24 participants were enrolled in Part 1 and 8 participants in Part 2. The study was conducted, at 3 centers in United States of America from 29 June 2016 to 20 June 2017.|A total of 43 participants were screened of which 8 were screen-failures and 32 were enrolled in the study and 3 participants were reserve participants and were no longer required in the study .
718628|NCT02729025|This study was conducted at 14 centers in Canada, the Netherlands, and the United States. Participants were enrolled from 14 April 2016 to 07 December 2017.|Eligible participants were randomized in a 1:1 ratio to receive either evolocumab or placebo. Randomization was stratified by baseline background statin therapy (on statin versus not on statin) and by screening lipoprotein(a) (Lp[a]) (< 175 mg/dL or ≥ 175 mg/dL).
718629|NCT02728895|Participants took part in the study at 5 investigative sites in the United States from 15 June 2016 to 10 July 2018.|Participants undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) were enrolled to receive vedolizumab intravenous 75 milligram (mg) or 300 mg along with standard graft-versus-host disease (GvHD) prophylaxis therapy (tacrolimus plus short team methotrexate).
718630|NCT02728830||Of the 39 subjects that were consented, 24 were screen failures. Nine were screen failures because exclusionary surgery, 6 because of exclusionary pathology, 3 because physician decision, 2 because of participant withdrawals, 1 was lost to follow up, 1 had exclusionary lab values, 1 had a contraindicated illness, and 1 had a language barrier.
718631|NCT02728258|Opened to screening 1/23/2017. The first patient was enrolled in March 2017 and the last patient was enrolled in May 2017. The study was officially closed to accrual on 8/7/2017 after the first stage of accrual was completed and all screened patients were either enrolled or refused. The study did not continue on to the second stage of accrual.|"Tumor samples were screened for somatic hotspot PIK3CA gene mutations prior to enrollment."
722884|NCT02329964|Recruitment period : 2015.2.10 - 2015.6.30 Location : Korea University Medical Center Anam Hospital|
722885|NCT02329743||
718634|NCT02727894|From March 2013 till September 2015 in 12 centres across the Czech Republic 276 patients were enrolled.|Patients with diagnosed colorectal carcinoma were enrolled (276). 11 patients were excluded because of the inability to categorise those patients into the screening or non-screening group.
718635|NCT02727842||
718636|NCT02727816||
718637|NCT02727777|Recruitment was open from 03/01/2017 to 11/27/2017|No significant events in the study occurred after enrollment, prior to assignment to arm/group
718638|NCT02727751||
718639|NCT02727660|This study screened subjects at 292 study centers in 18 countries and randomized subjects at 259 study centers, from April 2016 to April 2018.|Subjects were randomized in a 1:1:1 ratio to BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, and FF MDI 9.6 μg treatment groups
718640|NCT02727322||
718641|NCT02726971||
718642|NCT02726945|Recruitment opened April 2015 and the first subject was enrolled in the study in July 2016. Recruitment was completed in September 2017.|
718643|NCT02726789||
718644|NCT02726620||
718645|NCT02726451||
718646|NCT02726399||
718647|NCT02726178|The recruitment process was conducted in the neonatal intensive care unit of Sainte-Justine University Hospital (CHU Sainte-Justine, Montreal, QC, Canada) over a period of fourteen months (February 2010 - March 2011).|A total of 362 preterm infants were screened, 56 completed the study. Of the infants who did not participate in the study, 212 were discharged before the first immunization (92 to home and 120 to level II nurseries), 37 died, 28 were still intubated at the time of enrolment, 14 did not meet the inclusion criteria, and parents refused for 15.
718648|NCT02726113|Subjects with diagnosed prostate cancer, who were scheduled for prostatectomy, were randomized into D3 supplementation vs Placebo groups prior to surgey|Overall Study
718649|NCT02726074|Participants took part in the study at 11 investigative sites in Korea from 03 May 2016 to 26 April 2018.|A total of 106 participants were enrolled in this study, 102 participants were included in the safety set excluding 3 participants who did not received the investigational product and 1 participant who was not assessed for safety at least once after study treatment.
718650|NCT02726022||
718651|NCT02725866||Safety population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known.
718652|NCT02725801||
718653|NCT02725788|From September 24, 2014 to May 12, 2015 at five U.S. hospitals|
718654|NCT02725710|Recruited between August 2016 and June 2018.|One subject randomized to gabapentin withdrew from the procedure.
718655|NCT02725671||
718656|NCT02725645|elementary school children, male and female, with no history of spine problems. Tutors provided legal authorization.|
718657|NCT02725593|Participants took part in the study at 42 study centres in 7 countries worldwide.|
718658|NCT02725515|First informed consent date: 16FEB2016 First randomization date: 07MAR2016 Last informed consent date: 09NOV2017 Last randomization date: 07DEC2017|After obtaining informed consent, IM depomedrol was administered and screening studies were performed over the 2-4 week screening period. Immunosuppressive therapy must have been stopped or tapered off by randomization on Day 1. Patients who did not meet the disease activity improvement criteria during the screening period were not randomized.
718659|NCT02725476||
718660|NCT02725411||
718661|NCT02725268|Participants took part in the study at 60 investigative sites in Australia, Belgium, Germany, Italy, Netherlands, Norway, Spain, United Kingdom, Canada and the United States from 08 September 2016 to 23 July 2019.|The female participants with a diagnosis of endometrial carcinoma were enrolled and randomized into 1:1:1:1 ratio to receive single agent paclitaxel, paclitaxel in combination with sapanisertib, single agent sapanisertib or sapanisertib in combination with MLN1117.
718662|NCT02725008|Pediatric Emergency Department|99 participants were enrolled, 2 participants underwent initial enrollment but were not randomized to a group, leaving 97 participants who were assigned to a study group.
718663|NCT02724839|A total of 36 parent-child dyads (72 individual participants) were consented and enrolled over the entire course of the study starting with recruitment in February 2016 and ending with the final session in July 2018.|
718664|NCT02724800||"92 participants met initial eligibility criteria and signed informed consent to participate in the study.
~However, only 63 participants met full criteria to participate and were randomized to a treatment arm."
718665|NCT02724787||
718666|NCT02724644||
718667|NCT02724449||
718668|NCT02724111|This study was a single-site study recruited and performed at Korea University Guro Hospital, a general hospital, Seoul, South Korea, from 15 May 2016 to 16 February 2017.|No enrolled participants were excluded from the study before assignment to arms or groups.
718669|NCT02724033||
718670|NCT02723916|Recruitment occurred from April 2016 - April 2018|No pre-assignment in study.
718671|NCT02723786|This was a single arm study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of GSK1070806 plus standard of care (SOC) for the prevention of delayed graft function in adult participants after renal transplantation.|A total of 10 participants were screened for the study, and 7 of them received study treatment. The study enrolled participants in 4 centers across 2 countries (Spain and United Kingdom).
718672|NCT02723630||
718673|NCT02723591||Participants of ≥16 years and ≤70 of age requiring kidney transplant were enrolled. Randomization was stratified by alemtuzumab (yes/no), kidney donor profile index (KDPI) (3 levels: N/A [living donors] versus ≤50 versus >50), and human leukocyte antigens (HLA) Class II mismatch (yes/no).
718674|NCT02723344|Although 75 participants were consented and enrolled in the study, 31 participants met inclusion criteria and continued participation.|
718675|NCT02723201|Participants took part in the study at 1 investigative site in the United Kingdom from 28 April 2016 to 24 August 2016.|Healthy participants were enrolled in 3 part study to receive TAK-020. Part-1: relative bio-availability of solid formulations, Part-2: effect of food on co-crystal tablet(CCT) and Part-3: dose linearity of CCT. Part-3 was not conducted, as relative bioavailability of solid formulation was greater than(>) 50% compared with oral solution of TAK-020.
718676|NCT02723188||
718677|NCT02723175||
718678|NCT02723084||Intent-to-treat population: all participants who received at least 1 dose of study drug.
718679|NCT02722967|This open-label, single-arm trial assessed the functionality of an integrated call center for digital medicine system (DMS) as used by adult subjects (18 to 65 years of age, inclusive, at the time of screening) with Schizophrenia (SCH), Bipolar 1 disorder (BP1), or Major depressive disorder (MDD) being treated with oral aripiprazole.|The trial consisted of a screening period of ≤ 7 days. This period assessed the eligibility criteria at 1 or more visits. An interactive web response system (IWRS) was used to obtain an identification number for each subject with a signed electronic informed consent form (eICF).
718680|NCT02722928||
718681|NCT02722863||
718682|NCT02722837|Participants were enrolled at study sites in the Russian Federation and Sweden. The first participant was screened on 04 April 2016 and the last study visit occurred on 13 September 2017.|122 participants were screened.
718683|NCT02722577||Presence of clinical arrhythmia during the ablation procedure is a requirement for the study protocol and can not be guaranteed at the time of enrollment. 2 of the patients who have consented did not have clinical arrhythmia present at the time of the ablation procedure and were therefore not included in the study.
718684|NCT02722564||
718685|NCT02722408||
718686|NCT02722330||
718687|NCT02722304|The study was conducted at 4 study centers in the United States (3) and Australia (1) between 02 November 2016 (first participant first visit) and 14 September 2018 (last participant last visit).|A total of 22 participants were screened for entry of study, of these, 15 participants were considered screen failures. Remaining 7 participants were enrolled and randomized in the study.
718688|NCT02722278||
718689|NCT02722239|Participants recruited from one medical clinic located in Moscow, Russia in March and April 2016.|46 subjects were screened, 40 randomized (2 did not meet inclusion criteria and 4 were back-up volunteers).
718690|NCT02722148||
718691|NCT02722044|A total of 51 participants were screened, and 33 participants were enrolled in the study.|
718692|NCT02721966|503 participants completed the screening period; and the randomized set consists of 498 patients because 5 participants were misrandomized|95.6% of those randomized completed period 1 and moved on to period 2; and the 85.3% completed treatment period 2.
718693|NCT02721875||
718694|NCT02721641||
718695|NCT02721277||
718696|NCT02721147||Participants are randomized only after 1) both partners in the couple complete consent/baseline and 2) the first telephone session is scheduled. Patients who consent without their partner or couples who consent and do not schedule sessions are not randomized.
718697|NCT02720952||
718698|NCT02720757|This was an open-label observational study conducted in 6 countries, enrolling consented Chronic Obstructive Pulmonary Disorder (COPD) patients who received treatment with Spiolto® Respimat® according to the approved summary of product characteristics (SmPc).|Patients were enrolled consecutively and were followed over an observational period of approximately 6 weeks, which was the average time between two medical consultations
718699|NCT02720627||
718700|NCT02720536||All patients completed study CICL670F2201 (NCT02125877) prior to entry into this study
718701|NCT02720523|"Participants with active rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease-modifying anti-rheumatic drug (csDMARDs) were enrolled at 49 sites in Japan.
~The study is currently ongoing, results are reported up to Week 60, as of the data cutoff date of 12 July 2018."|Participants were randomized to 1 of 3 doses of upadacitinib or placebo in Period 1. Participants who completed week 12 could continue in the study; participants in the upadacitinib groups continued on the same dose of upadacitinib, participants in the placebo group switched to upadacitinib 7.5, 15, or 30 mg per the pre-specified randomization.
718702|NCT02720510|A total of 6 patients were randomized and treated in the study. None of the patient completed the study and all patients were discontinued.|
718703|NCT02720484|The study opened for accrual on March 22 2016 with an accrual goal of up to 33 patients. The first patient started treatment March 30, 2016. Accrual was suspended on December 5, 2016 after the first 10 patients were enrolled for Interim Analysis. The study was closed permanently on May 24 2017 with no additional patients enrolled.|
718704|NCT02720224||
718705|NCT02720198|Potential participants were identified by self-referral via the printed ad, phone script, the patients' physicians, local health providers, mental health providers, or Duke providers. Others were recommended by PI or Study Coordinator. They assessed and screened at 2 sites, an university hospital and a clinic of the research institute.|One subject was lost to follow up after screening.
718706|NCT02720107||There were 133 patients enrolled in the study but only 130 received drug
718707|NCT02720081||
718708|NCT02720042|Study subjects were enrolled between 22-Mar-2016 and 26-Apr-2017 at 15 different sites in 8 European countries.|
718709|NCT02719938|March 2016 to August 2017 enrolled dyads of hospitalized patients with late-stage dementia and family decision-makers.|
718710|NCT02719743||
718711|NCT02719639|This is an open label observational study in Chronic Obstructive Pulmonary Disease (COPD) patients from 534 investigational sites in 9 countries.|All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial if any one of the specific entry criteria were not met.
718712|NCT02719535||
718713|NCT02719522|Patients have been enrolled in 21 sites in EU, Australia and Israel between 24-Mar-2016 and 27-Sep-2017.|
718714|NCT02719366||
718715|NCT02719353||
718716|NCT02719171||This study included a 6-week screening period.
718717|NCT02719158||
718718|NCT02719028|A multi-center, phase II, prospective, double blind, randomized, placebo-controlled trial, recruiting from 23-Jun-2016 to 30-Aug-2018 6 sites are NTUniversity Hospital; CMU Hospital; NCKU Hospital; Taipei VG Hospital; FEM Hospital; CGM Hospital, Linkou branch;|total treatment period: 16 weeks including a 2-week screening visit, a 12-week study treatment, and a 2-week follow-up
718719|NCT02718963||There was no significant event in the study after participant enrollment
718720|NCT02718898||"12 week Blinded Treatment period, followed by 40 week Open Label Treatment Period, followed by 12 week Post treatment follow-up period.
~ttt = treatment, Pt = Participant."
722886|NCT02329730||
722887|NCT02329600||
718721|NCT02718625|This study was conducted from 10October2016 to 09March2017. The study was cancelled by the sponsor due to low enrollment despite several attempts and measures to improve recruitment. Therefore, the study was not feasible to continue and an early termination was needed.|
718722|NCT02718417||
718723|NCT02718326|Recruitment for this study was conducted in the following countries between 29 Mar 2016 and 07 Aug 2017: Germany, Hungary, Japan, the United Kingdom, and the United States. A total of 759 participants were screened.|Out of 759, 402 participants were randomized to receive 1 of 3 treatment groups in a 1:1:1 ratio stratified based on their Diabetic Retinopathy Severity Scale (DRSS) score (level 47 vs. level 53). Only 1 eye was selected as the study eye.
718724|NCT02718248|Participant recruitment took place over a 6 month period from Sept. 2016 to Feb. 2017. TOH ED staff were asked to approach participants with information about the study and refer any eligible men to the Research Coordinator. Once participants were referred to the Research Coordinator, she contacted them by telephone and scheduled a Baseline Visit.|No participants were excluded from this study post-enrollment.
718725|NCT02718157||
718726|NCT02718118||
718727|NCT02718040||
718728|NCT02717949||
718729|NCT02717754|In total 99 participants were included in study, but as first 50 participants were administered infusion incorrectly thus only 49 participants were considered evaluable for pharmacokinetics. The 50 participants were reported for safety under arm groups placebo (incorrect infusion duration), oseltamivir 100 or 200 mg (incorrect infusion duration).|
718730|NCT02717494|Recruitment period was from April 2016 to November 2017. Participants were recruited from medical clinics.|"Of the 347 pregnant women enrolled in the study, 346 were randomized and received study vaccination. One discontinued study prior to receiving study vaccination.
~There were 349 infants born on the study, including 4 sets of twins. Two women discontinued study prior to delivering their child. Those children are not included in the outcome results."
718731|NCT02717273||
718732|NCT02717195||Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period. Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment.
718733|NCT02717130||
718734|NCT02716987|Participants took part in the study at 2 investigative sites in the United Kingdom from 21-Mar-2016 to 30-Aug-2016.|Healthy participants in Set A received up to 100 megabecquerel (MBq) of [18F]PGM299 for 3 PET scans at baseline, 2, and 26 hours post TAK-831. Set A participants also received a single dose of TAK-831 (100 milligram [mg], 200 mg, 250 mg, or 500 mg). Healthy participants in Set B received up 100 MBq of [18F]PGM299 for 2 PET scans on Day 1 and 10.
718735|NCT02716896||
718736|NCT02716818|This study was conducted at 11 study sites in 7 countries: Denmark 1, France 2, Germany 1,Netherlands 1, Sweden 1, UK 4, and USA 1.|Following written informed consent and screening tests (Visit 0), eligible participants were called back for the baseline visit. As part of the baseline assessment, participants were admitted overnight for a 24- hour endocrine profile whilst remaining on their standard therapy. Participants were then randomised to Chronocort or standard therapy.
718737|NCT02716805||
718738|NCT02716779||Enrollment was 68: 1 participant withdrew during the screening phase and 67 participants were randomized.
718739|NCT02716727||
718740|NCT02716714|This study enrolled patients with actinic keratosis (AK) patients with the lesions on the face, scalp, trunk and/or extremities from 10 academic medical centers in South Korea. First subject was enrolled on 06 Apr 2015 and Last subject was completed on 13 Jun 2016.|
718741|NCT02716584||
718742|NCT02716506||
718743|NCT02716324|From 3/2016-7/2017, primary care clinicians at participating pediatric practices nominated eligible patients for recruitment. Eligible patients were contacted by phone and then underwent in-person informed consent. Participants were stratified by practice, age group (5-7 or 8-12 years old), and sex and randomized 1:1 to the two study arms.|Eligible participants were excluded prior to enrollment if they had history of suicide, bipolar disorder, schizophrenia, autism, or conduct disorder.
718744|NCT02716298||
718745|NCT02716194|The study was conducted at 20 study sites in the EU and Russia. 44 participants signed informed consent. Of these, 4 participants were not treated (2 screen failures and 2 participants withdrew from study prior to receiving any dosing).|44 participants signed informed consent. Of these, 4 participants were not treated (2 screen failures and 2 participants withdrew from study prior to receiving any dosing).
718746|NCT02715804|A total of 492 participants were enrolled from 14 March 2016 through 26 December 2018 in 20 countries.|A total of 492 participants were enrolled and randomized in 2:1 ratio to received either PAG (PEGPH20 + Nab-paclitaxel + Gemcitabine) or AG (Placebo + Nab-paclitaxel + Gemcitabine).
718747|NCT02715765|The PI for this study has left the institution. After extensive effort to locate more information, only limited study data is available. 3 participants were enrolled, however no baseline data was collected/is available.|
718748|NCT02715726|The study was conducted at 61 centers in China, India and Thailand. Overall 1163 participants were screened between 27 July 2016 and 18 December 2017, of whom 548 were screen failures. Screen failures were mainly due to exclusion criteria met. A total of 615 participants were randomized in 2:1 ratio to alirocumab: ezetimibe.|Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke [Yes/No], and high-intensity statin treatment (Yes: atorvastatin 40 to 80 mg daily or rosuvastatin 20 to 40 mg daily, no: atorvastatin below 40 mg daily, rosuvastatin below 20 mg daily or simvastatin whatever the dose daily) and country.
718749|NCT02715700|Adult male and female participants on stable methadone maintenance therapy were recruited at 2 study sites in the United States.|
718750|NCT02714868|Convenience sample, recruited from partnering community agencies and schools|Non- randomized assignment
718783|NCT02711995|Eight patients were enrolled in the study, and seven patients completed the study. The first participant enrolled on December 15, 2015 and the last patient completed the study on September 29, 2016. All patients were seen at Weill Cornell Medicine ENT located at 1305 York Avenue,5th Floor NY NY 10021|One patient was excluded prior to the second intervention. Her neurologist started her on a medication that could have confounded our findings, therefore her participation in the study ended. She still received treatment, but was no longer considered a study subject.
718784|NCT02711839||
718751|NCT02714595|This study enrolled hospitalized patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), bloodstream infection (BSI), sepsis, or complicated urinary tract infection (cUTI) caused by carbapenem-resistant Gram-negative pathogens, and was conducted at 95 sites in 16 countries.|Participants were randomized in a 2:1 ratio to receive therapy with cefiderocol or best available therapy (BAT), stratified by primary clinical diagnosis (HAP/VAP/HCAP, BSI/sepsis, cUTI), Acute Physiology and Chronic Health Evaluation (APACHE) II score (≤ 15 or ≥ 16-≤ 30), and region (North America, South America region, Europe, Asia-Pacific).
718752|NCT02714504||
718753|NCT02714426||
718754|NCT02714400||
718755|NCT02714283|Complete national 2006-2014 Medicare data from Part A, B and D (but not C) were obtained from Center for Medicare and Medicaid Services for patients with ICD-9-CM code 494.0 or 494.1 (bronchiectasis without or with acute exacerbation).|From the identified bronchiectasis cohort, we excluded patients with cystic fibrosis, HIV infection, or a history of organ transplant. Such patients are fundamentally different than non-CF bronchiectasis patients who lack these factors with regard to their risk for infection, hospitalization, and many of the outcomes under study in this proposal.
718756|NCT02714218||481 participants were enrolled, 387 randomized (180 N3I1, 180 N1I3, 27 Cohort C/N6I1), 385 treated (180 N3I1, 178 N1I3, 27 Cohort C/N6I1). Reasons not treated: 1 did not meet study criteria, 1 other reason. Cohort C/N6I1 assessed for exploratory outcome measures not being reported in the Outcome Measures module. Safety data included with AE data.
718757|NCT02714062||
718758|NCT02713867||363 Enrolled (Randomized), 358 Treated; reasons not treated: 3 Other Reasons, 2 withdrew consent.
718759|NCT02713828||
718760|NCT02713789||
718761|NCT02713698||
718762|NCT02713659||
718763|NCT02713594||
718764|NCT02713542|A total of 126 patients were evaluated and 90 were treated at four sites|A total of 36 patients were excluded before randomization to groups due to not meeting Inclusion/Exclusion criteria.
718765|NCT02713529|This study was conducted at 15 centers in Australia, Canada, United States of America, and Europe.|Part 1 was a phase Ib safety study comprised of two cohorts. Part 2 was a phase 2 safety and efficacy study comprised of 5 groups.
718766|NCT02713490|Participants were recruited between April 18, 2016 and February 8, 2017 at 16 sites in the United States|A total of 167 patients were screened; there were 27 screen failures, including 2 patients who were randomized in error to the EXPAREL 266 mg + bupivacaine hydrochloride (HCl) group.
718767|NCT02713425||
718768|NCT02713256||
718769|NCT02713243|In total, 20 patients were enrolled in this study and received at least one dose of LJN452 or matching placebo for 14 days in Period 1. There will be a washout period between 7 to 28 days followed by Period 2 drug if patient on LJN452 or Placebo in Period 1 they will take Placebo or LJN452 respectively in Period 2 for 14 days|
718770|NCT02713230|Participants were recruited between May 9, 2016 and July 7, 2017 at 16 sites in the US and Europe|"Started does not include one patient who was a screen failure, was not enrolled, and was randomized to placebo in error."
718771|NCT02713204|The study was conducted at 87 sites in the United States. A total of 560 participants were screened in the study.|Out of 560 participants, 365 were randomized & treated. Participants were randomized in 1:2:3 to receive REGN910-3 3:2mg, REGN910-3 6:2mg & 2mg intravitreal aflibercept injection (IAI) followed by re-randomization at week 12 in REGN910-3 6:2mg & IAI 2mg arm. Not all participants who completed Week 12 were re-randomized & continued to Week 36.
718772|NCT02713178|Participants were recruited between June 3, 2016 and June 30, 2017 at 13 sites in the US and Europe|
718773|NCT02712996||Of 20 enrolled participants, 3 never began the trial due to scheduling problems or competing demands.
718774|NCT02712983|A total of 107 subjects were enrolled in the trial from 6 countries (Belgium [2 sites], France [4 sites], Germany [5 sites], Italy [6 sites], Spain [8 sites] and United Kingdom [9 sites]).|This study planned to recruit approximately 180 subjects to one of the 3 cohorts in a ratio of 1:1:1. The subjects within each cohort were randomized to blinded TIP or placebo with the following randomization scheme: TIP:TIP/Placebo cyclical:Placebo, in a 2:2:1 ratio.
718775|NCT02712788||
718776|NCT02712554|Total 12 subjects were enrolled and completed the Dose Selection phase. Subjects randomized to the Treatment phase were 40 and all of them received at least 1 dose of study drug, and 37 subjects completed the study.|
718777|NCT02712359|The study was conducted at 4 centers in Panama. Out of the 1201 subjects originally enrolled in the study, 2 subjects were eliminated from the ATP cohort for persistence, due to non-eligibility. Hence, 1199 subjects were included in the ATP cohort for persistence.|The design of the study included 2 epochs: Epoch 001 - Persistence at Year 8 and Epoch 002 - Persistence at Year 10.
718778|NCT02712333|Recruitment was conducted on November, 2015 in Jiangwan Campus, Fudan University. A total of 65 participants were assessed for eligibility and 60 of them were finally recruited|
718779|NCT02712320|All subjects were males with advanced prostate carcinoma that completed 12 months (48-week) of therapy with Leuprolide Mesylate Injectable Suspension (LMIS) 50 mg under the Protocol FP01C-13-001 and were suitable candidates for continued medical androgen ablation therapy as judged by investigators.|
718780|NCT02712099|"study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital from August 2015 to march 2016.
~Fifty pregnant women In whom the transabdominal scan revealed evidence of anterior placenta previa were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria."|
718781|NCT02712047|This was a randomized, double blind, placebo-controlled, two-period, crossover repeat dose study in adult participants with asthma. The study was conducted from 29 April 2016 to 21 February 2017, at a single site in New Zealand.|Total 36 participants were screened, of which 8 participants were screen failures. Of the 28 participants who were enrolled in the study, 27 participants were randomized as 1 participant withdrew before randomization. The study had Run-in period of 7 days, which was followed by a Treatment period (TP) 1, a wash-out period of 21 days and TP2.
718782|NCT02712008|The study was conducted at 70 sites in US. A total of 438 participants were screened in the study.|Out of 438 participants, 302 were randomized & treated in study. Participants were randomized in 1:2:3 to receive REGN910-3 3:2mg, REGN910-3 6:2mg & 2mg intravitreal aflibercept injection followed by re-randomization at week 12 in REGN910-3 6:2mg & IAI 2mg arm. Not all participants who completed Week 12 were re-randomized & continued to Week 36.
718791|NCT02710591|The recruitment period varied depending on the recruitment speed ; started in March 2016 to November 2017. it was competitive among the 4 sites: France, Spain, Italy and UK. A time interval of at least 1 week was maintained between adminstration of first dose in the first 3 patients of each cohort. It was extended to all patients for cohort 4.|"Screening details:
~Screening was carried out within 4 week prior to first administration of Rimeporide (SD1) to enable confirmation of patient eligibility and following the signature of the Informed Consent Form."
718792|NCT02710526||
718793|NCT02710422||
718794|NCT02710292|Subjects were recruited from 6 study sites located in Japan.|Of the 104 subjects, 5 were exited as screen failures prior to being enrolled. This reporting group includes all enrolled subjects (99).
718795|NCT02710214||
718796|NCT02710136|Of the 182 participants recruited, 80 participants consented to be screened for study eligibility. Among the five participating clinical research sites, all located in the United States, 35 participants enrolled to participate in the study. Enrollment was active from February 2016 to March 2017.|
718797|NCT02710071||41 of 405 participants were randomized. Of those not randomized, 364 did not meet inclusion criteria
718798|NCT02710045||
718799|NCT02709889||Participants were enrolled into a standard 3+3 dose-escalation study within disease-specific cohorts in Part A, and then participants were enrolled into a disease-specific expansion cohort in Part B based on the maximum tolerated dose determined in Part A.
718800|NCT02709785|Subjects recruited from Graduate Periodontics clinic at two universities.|
718801|NCT02709746||Patients who did not fulfil the randomization criteria for the Double-blind treatment (DBT) Period, were withdrawn from the study after the Single-blind treatment (SBT) period. Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period.
718802|NCT02709577||
718803|NCT02709538||
718804|NCT02709486||
718805|NCT02709369||
718806|NCT02709330|Subjects were recruited from the clinic patient population and outside advertisements and postings. Recruitment began 3/28/2016 and ended 9/14/16 once 50 subjects had been enrolled. Study visits were conducted at the Duke ALS clinic and via phone contacts.|An additional 10 subjects were consented specifically as controls for outcome measure 2 and not included in the treatment group (Lunasin regimen).
718807|NCT02709096||
718808|NCT02709083||
718809|NCT02709005|Women, 18-50 years old, with clinical evidence of bacterial vaginosis, were identified during a routine clinic visit, referred by their care provider, or recruited directly to the research clinic between May 11, 2016 and November 16, 2017.|
718810|NCT02708966||
718811|NCT02708862||There were 26 total subjects; each did all 4 arms.
718812|NCT02708849||
718813|NCT02708745||
718814|NCT02708524||A total of 554 subjects were enrolled in this study. Of the enrolled subjects 6 subjects did not meet the eligibility criteria and 548 subjects were dispensed a study lens. Of the dispensed subjects 535 subjects completed the study and 13 subjects were discontinued.
718815|NCT02708498||
718816|NCT02708485||
718817|NCT02708433||
718818|NCT02708355||
718819|NCT02708290||"MITA was made available gratis at all app stores from 2015 to 2020. From this pool of potential study participants, we selected participants for the observation clinical study based on the following criteria:
~Consistency: at least three ATEC evaluations completed.
~The interval between the first and the last evaluation was six months or longer.
~Diagnosis: ASD
~Age: 2 to 12 years
~This resulted in 6454 participants, from whom we have selected the test and control groups"
718820|NCT02708277|From January 2011 to February 2013, women with severe intrauterine adhesions who presented with a history of infertility were initially included in the study.|Exclusion criteria: endometrial tuberculosis, grossly abnormal semen analysis, ovarian failure, hydrosalpinx fluid, and patients who did not proceed to second-look hysteroscopy within the specified time frame，women with no desire to pregnancy.
718821|NCT02708238||
718822|NCT02708212|Total 129 patients were invited to participate in the study from April to July 2016, and 8 patients were excluded. Finally, 121 patients were recruited for the study which was performed in a community hospital (Evergreen General Hospital). One patient in the EGD-colonoscopy was further excluded from final analysis due to poor bowel preparation.|Eight patients were excluded from assignment due to refusal to provide informed consent (n=3), American Society of Anesthesiology class 3 (n=3), duodenal peptic stricture (n =1), and partial colectomy (n=1).
718823|NCT02708186||
718824|NCT02708121|All six providers who were recruited through a Duke Health primary care-based research network and were present at a primary care clinic provider meeting in February 2017, were eligible and consented to participate. Patients of the enrolled providers were recruited from May 2017 to August 2017 through an electronic health record database search.|None of the providers were withdrawn from the study. Of the 66 patients initially consented, 6 withdrew prior to learning their randomization assignment; 4 chose to withdraw for no stated reason; one was withdrawn by the study team due to being in treatment; and one was withdrawn by the study team due to canceling their index appointment.
718825|NCT02708095||
718826|NCT02707991|Recruitment took place from July 2016 to February 2018 in an outpatient infectious disease clinic in Baltimore, Maryland|
718827|NCT02707965||
718828|NCT02707952||Intent-to-treat population: all participants who received at least 1 dose of study drug
718829|NCT02707640||
718830|NCT02707601|Participants were enrolled at study sites in the United States. The first participant was screened on 01 April 2016. The last study visit occurred on 29 September 2017.|259 participants were screened.
718831|NCT02707523||
718832|NCT02707432||
718833|NCT02707172|Participants were recruited from Kaohsiung Medical university in Kaohsiung City, Taiwan from May, 2013 to September, 2013.|
718834|NCT02707146||
718901|NCT02699684|Subjects were recruited from 1 study center located in the United Kingdom (UK).|Of the 82 enrolled, 6 subjects were exited as screen failures prior to randomization. One subject withdrew consent after randomization, but before exposure to product. This reporting group includes all randomized and exposed subjects (75).
718902|NCT02699632||
718835|NCT02706951|"A total of 648 participants with rheumatoid arthritis (RA) on a stable dose of methotrexate (MTX) were randomized at 138 study sites located in 24 countries.
~The study is currently ongoing; results are reported up to the end of Period 1 (Week 14)."|"Participants were randomized in a 2:2:1:1 ratio to 1 of 4 groups:
~Upadacitinib 30 mg (Periods 1 and 2)
~Upadacitinib 15 mg (Periods 1 and 2)
~MTX (Period 1) → upadacitinib 30 mg (Period 2)
~MTX (Period 1) → upadacitinib 15 mg (Period 2)
~Randomization was stratified by geographic region. The MTX groups were pooled for Week 14 analyses."
718836|NCT02706938|This trial was conducted at the outpatient visit of the Gastroenterology, Digestive endoscopy and Liver Diseases Unit in Clínica Fundadores, Bogotá, Colombia. A search for eligible patients was also conducted by using a Local Endoscopy Database with a time frame from 2014 to 2016, and patients with esophagitis were contacted by telephone.|1082 out of 1147 potentially eligible patients were excluded prior to randomization. 941 patients did not meet the inclusion criteria and 105 patients had at least one exclusion criteria. 36 patients declined their participation before starting the clinical trial.
718837|NCT02706925|This trial was performed as a partially randomised, placebo-controlled within parallel dose groups, single-blind trial.|All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
718838|NCT02706899||
718839|NCT02706886|Participants were enrolled at ten sites in Germany, France, the United Kingdom, Israel, and the Netherlands.|In Part A, single ascending dose (SAD) part, healthy adults were dosed with lumasiran or placebo once. In Part B, multiple ascending doses (MAD) part, patients with primary hyperoxaluria type 1 (PH1) were dosed with lumasiran or placebo. All patients, who initially received placebo, received lumasiran after completing placebo dosing.
718840|NCT02706873|Participants were randomized at 136 sites in 43 countries. The study included 2 periods and a Japan sub-study. The global study analysis included participants from Japan, but excluded the upadacitinib 7.5 mg group. The Japan sub-study included all participants from Japan, including the upadacitinib 7.5 mg group.|"Participants were randomized in a 1:1:1 ratio to Groups 1, 3, and 4 below, except for participants in Japan who were randomized in a 1:2:1:1 ratio to Groups 1, 2, 3, and 4. Randomization was stratified by geographic region.
~Results are reported up to Week 24 of Period 1. Efficacy analyses were conducted separately for the Japan sub-study."
718841|NCT02706847|Participants were enrolled at 152 sites located in 26 countries from March 2016 to January 2017. Eligible participants had active rheumatoid arthritis (RA) and previous inadequate response or intolerance to biologic disease-modifying anti-rheumatic drugs (bDMARDs), and were receiving concomitant background conventional synthetic DMARDS (csDMARDs).|"Participants were randomized in a 1:1:2:2 ratio to one of the 4 treatment groups below. Randomization was stratified by the number of previous bDMARDs used and geographic region.
~The study is ongoing and data up to week 24 are reported here."
718842|NCT02706834|Participants took part in the study at 2 investigative sites in the United States from 01 March 2016 to 17 June 2016.|Non-Japanese healthy participants were randomized to Cohort 1 or Cohort 2 with 4 different sequences to receive TAK-828 or placebo in a ratio of 9:3. Japanese healthy participants were randomized into Cohort 3 with 3 different sequences to receive TAK-828 or placebo in a ratio of 8:4.
718843|NCT02706717|Enrollment began in 04/2016 and completed in 12/2016.|
718844|NCT02706691||
718845|NCT02706483|Eligible subjects with IBS-C from SP304203-04 (NCT02387359), SP304203-05 (NCT02493452), and SP304-20212 (NCT01722318), and subjects that did not previously participate in any plecanatide study, were enrolled.|
718846|NCT02706327|This study was conducted between January 2014 and January 2016 at an outpatient clinic. Eligible participants were randomly assigned into three groups using simple randomization procedures.|
718847|NCT02705807|This study consisted a screening visit, a Run-in period of a maximum of 30 days observation, a 4-week treatment period with the thermostable formulation of FLOLAN, and a one-week follow-up visit.|Ten participants (par.) who gave consent and passed the screening assessments were enrolled in the Run-in period. After the Run-in period, par. underwent Baseline assessments and were switched to thermostable formulation of FLOLAN. All par. underwent right heart catheterisation (RHC) up to 24 hours and at Week 4 after switching to study treatment.
718848|NCT02705716|Participants were recruited at one center (2 sites) in United Kingdom.|A total of 409 participants were screened, out of which 142 participants were randomized. 267 participants were not randomized because 183 participants did not met the study criteria, 1 had adverse event, 2 were lost to follow up, 7 had protocol violation, 2 withdrew consent and 72 were not randomized for other reasons (not specified).
718849|NCT02705625||
718850|NCT02705586|From March 2016 to May 2016, 8 Parkinson's disease veterans and their caregivers were recruited for the 10-week Mindfulness-Based Stress Reduction classes held at the VA Portland Health Care System in Portland, Oregon.|13 participants consented for the study. 4 withdrew after screening prior to the intervention due to the amount of travel to the Portland VA in the study.
718851|NCT02705365||
718852|NCT02705352|Challenges recruiting patients into the study.|
718853|NCT02705105||
718854|NCT02704702||
718855|NCT02704689||
718856|NCT02704143|The recruitment period was from February 2016 to March 2018 in Changhai Hospital affiliated to Navy Medical University.|There were significant events that occur after participant enrollment, but prior to assignment of participants to an arm or group.
718857|NCT02704104|Patients were recruited who were to undergo excision of two skin lesions in the same sitting.|
718858|NCT02704091|The study enrolled adult participants with a recent episode of acute diarrhoea presumed of infectious origin, defined as the passage of 3 or more unformed (loose or watery) stools per day without alarm symptoms within the first 48 hours. Participants were randomised at 62 study centres in Algeria, Czech Republic, Egypt, Lebanon, Poland and Tunisia.|858 participants were randomised, of which 853 were included in the analysis and 5 were excluded due to invalid consent. Only participants included in the analysis are presented in the participant flow. Participants received a diary evaluation booklet (DEB) to record each stool plus consistency on a daily basis from inclusion until end of study.
718859|NCT02703987||Two subjects were terminated before randomisation (1 due to sponsor decision to withdraw, and 1 due to consent withdrawal).
718860|NCT02703948||
718861|NCT02703909||
718862|NCT02703636|The full analysis set (FAS) included all patients who received at least one dose of study treatment and had at least a baseline and any post-baseline assessment on treatment.|"In total, 147 patients were screened for the study. 129 completed screening and 18 discontinued from screening. 118 patients were enrolled and the remaining 11 patients discontinued at baseline.
~All 118 enrolled patients received study treatment. 102 completed the study and 16 discontinued"
718863|NCT02703532|Participant enrollment began in January 2016 and all study follow up was completed on January 8, 2019. Participants were enrolled at Emory University Hospital in Atlanta, Georgia.|
718864|NCT02703467||
718865|NCT02703454||
718866|NCT02703350||Two-part study compared individualized doses of LY900014 (Test) to insulin lispro (Reference). Part A: LY900014 or insulin lispro once subcutaneously (SC) before, at, or after start of meal in each of 6 periods. Minimum 1 day washout. Part B: LY900014 or insulin lispro SC before meals for 14 days. Participants were expected to complete both parts.
718867|NCT02703337||Two-part study compared individualized doses of LY900014 (Test) to insulin lispro (Reference). Part A: LY900014 or insulin lispro once subcutaneously (SC) before, at, or after start of meal in each of 6 periods. Minimum 1 day washout. Part B: LY900014 or insulin lispro SC before meals for 14 days. Participants were expected to complete both parts.
718868|NCT02703324||This study compared individualized doses of LY900014 (Test) to insulin lispro (Reference) when delivered via an insulin pump. The study consisted of four, three-day treatment periods, with a maximum of one week between doses in consecutive periods.
718869|NCT02703311||
718870|NCT02703259|Patient were recruited from June 2016 to July 2017 via phone or in the office setting. Potential subjects were informed of the study by investigators and if they desired to participate, they either signed consents forms in the office or on the day of surgery.|There were no events prior to assignment in study arm after participant enrollment.
718871|NCT02702999||
718872|NCT02702921|Recruitment was from Feb 2016 to Feb 2017 across 7 hospitals.|229 subjects signed an informed consent, 201 were randomized into one of the two groups. The 28 not randomized did not meet the inclusion criteria.
718873|NCT02702609|Participants were recruited and enrolled at 2 dental schools between August 2016 and June 2017.|
718874|NCT02702401|Although 278 participants were randomized to receive pembrolizumab and 135 to receive placebo, 1 participant in the placebo group received pembrolizumab in error. The efficacy population included all participants as randomized and the safety population was adjusted to account for actual treatment received (pembrolizumab = 279, placebo =134).|These results are based on a database cutoff date of 26-Mar-2018 for the primary analysis of progression-free survival (PFS) and 02-Jan-2019 for all other outcomes, at which time 128 participants were ongoing in the study.
718875|NCT02702193||Screening: 243 were screened of which there were 70 excluded (9 did not meet inclusion criteria; 32 declined participation; 29 were lost contacts)
718876|NCT02702011||
718877|NCT02701985||A total of 75 patients were randomized in a 1:1 ratio to RO5459072 or placebo (38 patients in the RO5459072 treatment group and 37 patients in the placebo group).
718878|NCT02701764||
718879|NCT02701647||
718880|NCT02701634|Participants were enrolled at study sites in Europe, Asia, Canada, and United States. The first participant was screened on 27 May 2016. The last study visit occurred on 06 Mar 2018.|89 participants were screened.
718881|NCT02701582|"Patients were prescreened and slate was given to PI for approval. Patients were approached in pre-op on day of surgery in a private setting. Study was discussed with them and questions were answered. If interested, they signed consent.
~Study team began screening patients after receiving IRB approval. The first patient was consented on 3/13/14."|
718882|NCT02701556||
718883|NCT02701387||
718884|NCT02701361|90 participants signed consent; 2 participants who signed consent were later found not to be eligible(88 eligible). 80 participants were randomized|
718885|NCT02701296||
718886|NCT02701270|Volunteers were recruited through the Study site (Leatherhead Food Research, UK) volunteer database in September - October 2015.|13 healthy volunteers were recruited, 12 volunteers were screened and one excluded (did not meet inclusion criteria).
718887|NCT02701257||
718888|NCT02701101||
718889|NCT02701049||
718890|NCT02700997||
718891|NCT02700984|Subjects were recruited from 23 study sites located in the US.|This reporting group includes all enrolled subjects (282).
718892|NCT02700919||
718893|NCT02700815|This was a randomised, placebo and active treatment-controlled, double-blind, parallel group study. Out of 757 enrolled patients with acute back or neck pain, 746 were randomised and treated with 4 topical treatments administered twice daily for 4 to 7 days.|All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial if any of the specific entry criteria were not met.
718894|NCT02700412|"Participants with treatment-resistant epilepsy in the state of Alabama were enrolled. Their primary treating neurologist provided the UAB CBD Treatment Approval Committee with the required information (found on www.uab.edu/cbd) to review. The committee either approved/recommended or disapproved/not recommended them for treatment in the study."|Of the total 129 participants with epilepsy ages 18 years and older screened, 80 were enrolled in this single-center, open-label study. This study was not randomized.
718895|NCT02700334||
718896|NCT02699996||
718897|NCT02699983||
718898|NCT02699970|The study started enrollment in February 2016 and enrollment was completed in April 2016. The full set of 420 features were used for the intra-system study as well as for the inter-system sub-study.|Features were evenly distributed over three magnifications (10x, 20x or 40x). 21 different feature types were included. Each feature type was divided over three organs.
718899|NCT02699892||There was no documentation for the reason for discontinuation; hence, in Participant Flow module, for all participants who did not complete the study, the reason is reported as Unspecified.
718900|NCT02699866|First site was initiated on 11th DEC 2015 (Mainz University). The first patient was included on 12 FEB 2016 and the last patient out was on 07 JUN 2019 (last 1-year follow-up). The last centre was closed on 10 DEC 2019 (Münster).|This was a non-randomized study (N/A).
718903|NCT02699593||A total of 142 subjects were enrolled into this study. Of the enrolled 1 subject did not meet the eligibility criteria and 141 were dispensed a study lens. Of the dispensed subjects 125 completed the study and 16 subjects were discontinued.
718904|NCT02699450||A total of 229 patients were randomized, but two participants randomized to Arm C: 6 mg Faricimab were excluded from the analysis populations due to Good Clinical Practice (GCP) non-compliance at a single site.
718905|NCT02699125|405 participants were screened for eligibility.|41 participant was enrolled in the study.
718906|NCT02699099||Subjects completed the study until Month 4.5. The results summary will be updated after subjects will complete the entire study period.
718907|NCT02698865||
718908|NCT02698800||
718909|NCT02698735|A sixth participant in this study (as proposed) was to be a RDEB patient without a nonsense mutation to act as a negative control. Since the patient had no chance to benefit from any treatment, and with the risks/expense/travel/biopsies we decided not to enroll such a patient.|
718910|NCT02698566||"Participant Flow module includes the number of patients enrolled (35) as well as the number of healthcare professionals (3) who administered intravitreal (ITV) injections to enrolled patients."
718911|NCT02698475||The results reported are for the main study (up to 56 weeks) and the long-term extension (LTE) results of the study will be reported once the study is completed.
718912|NCT02698436||
718913|NCT02698423||
718914|NCT02698410|This pilot study was conducted at 11 investigational sites in Italy between 06 July 2016 and 18 June 2019.|The study consisted of a screening period (maximum 4 weeks), followed by an open label treatment period of up to a maximum of 52 weeks or until disease progression, death or unacceptable toxicity, or subject/physician decision.
718915|NCT02698371|Participants were recruited from the Dental School Clinic of the Faculty of Health Sciences - UFP.|54 participants were screened. Of those, 38 participants met inclusion criteria and were enrolled.
718916|NCT02698241||A screening visit was required after a subject signed the informed consent form and before the baseline and programming visit. During the screening visit, subject's OptiVol Fluid Index and bloodwork were verified for the eligibility to continue the study. If subject failed the screening, he/she would exit the study.
718917|NCT02698189||Enrollment to the study was discontinued early based on a decision to terminate the MK-8628 program and based on limited efficacy signals and not due to safety-related concerns. This results disclosure is based on a data cutoff date of 09-May-2018; at which time 1 participant was ongoing in the study.
718918|NCT02698176|This was a dose-escalating study in participants with advanced or metastatic non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), castration-resistant prostate cancer (CRPC), or nuclear protein in testis (NUT) midline carcinoma (NMC) for which standard therapy does not exist, proven ineffective, intolerable, or unacceptable.|Participants with CRPC, NMC, and TNBC, as defined in the entry criteria, were enrolled; no participants with NSCLC were enrolled. All participants had a Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1 and 76.9% of participants had 2 or more prior lines of therapy. No participants were enrolled in Part B of the study.
718919|NCT02698033||
718920|NCT02697890||
718921|NCT02697773||
718922|NCT02697435|Using an IRB-approved waiver of consent, research coordinators (RCs) screened CPRS records of Veterans age 60-89 with low back pain.Those eligible were mailed a study brochure and a letter signed by the chief of Primary Care. Additional screening was performed on those who called the RC. Those eligible were further screened on site.|There was no wash out or run in period.
718923|NCT02697292||
718924|NCT02697240||
718925|NCT02697214||All 50 subjects wore 4 monitors each. i.e. EKG, H7 polar monitor, and 2 other randomly assigned heart rate monitors.
718926|NCT02697188|Cross over study with 5 periods. Twelve subjects enrolled and completed 5 crossover periods each.|
718927|NCT02696967|This study was conducted in 11 centers in 5 countries: Belgium (1), Germany (2), Netherlands (1), Singapore (1) and USA (6).|"Patients were assigned to one of the 2 treatment arms in fixed randomization ratio (CLR325: Placebo):
~Cohort 1: Single dose of CLR325 2.5 mcg/kg/min (i.v.) or placebo (i.v.)
~Cohort 2: Single dose of CLR325 0.25 mcg/kg/min (i.v.) or placebo (i.v.)
~Cohort 3: Single dose of CLR325 8 mcg/kg/min (i.v.) or placebo (i.v.)"
718928|NCT02696902|A total of 188 participants were assigned to the study treatment groups. Out of 188 participants, 4 participants did not receive the study treatment.|
718929|NCT02696850|Men and women aged 18 and older with a diagnosis of chronic rhinosinusitis were recruited from the Washington University in St. Louis School of Medicine Otolaryngology clinic from January 1, 2016 to February 16, 2017.|
718930|NCT02696798|Blinded Treatment Dosing Period (Week 0 to Week 16), Extended Treatment Period (Week 16 to Week 52) followed by post-treatment follow-up period occurring from last treatment visit (week 52), or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.|Participants who completed study were eligible to enroll into a long-term study (I1F-MC-RHBY [NCT03129100]) for up to 2 additional years. Participants who terminate study RHBW early or who do not enroll into Study RHBY will complete the Post-Treatment Follow-Up (PTFU) Period in study RHBW.
718931|NCT02696785|"Blinded treatment period (Week 0 to Week 16), followed by extended treatment period (Week 16 to Week 52), followed by post treatment period for a maximum of 24 weeks.
~Washout period occurred for only Adalimumab group for 6 weeks (Week 14 to Week 20)."|Participants who completed study were eligible to enroll into a long-term study (Study I1F-MC-RHBY [RHBY]) for up to 2 additional years. Participants that do not enroll into study RHBY will complete the Post-Treatment Follow-Up Period.
718932|NCT02696434||There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP.
718933|NCT02696317|Subjects were recruited from one study center located in the United Kingdom.|Of the 84 enrolled, 1 subject was exited as a screen failure prior to randomization. One subject was discontinued after randomization but prior to study lenses parameter optimization. This reporting group includes all subjects exposed to habitual or study lenses (82).
718934|NCT02696291|Healthy subjects were recruited from a phase 1 clinical research unit. Recruitment was initiated on 27 May 2016 and the last subject completed the final study visit for Cohort 1 on 02 March 2017.|
718939|NCT02696031|A total of 1583 patients were screened for this study, of which 555 patients (35.1%) were randomized. Overall, 1028 patients (64.9%) discontinued prior to screening phase completion, most due to screen failure (1000 patients, 63.2%).|5% of participants discontinued before or at week 24
718940|NCT02695719|Participants took part in the study at 13 investigative sites in Korea from 14 April 2016 to 24 February 2017.|Participants with a diagnosis of chronic idiopathic constipation as determined by the Rome III Diagnostic Criteria for Functional Constipation were enrolled in 1:1 ratio to receive lubiprostone or placebo.
718941|NCT02695628||
718942|NCT02695537|"Participants with treatment-resistant epilepsy in the state of Alabama were enrolled. Their primary treating neurologist provided the UAB CBD Treatment Approval Committee with the required information (found on www.uab.edu/cbd) to review. The committee either approved/recommended or disapproved/not recommended them for treatment in the study."|Of the total 141 participants with epilepsy ages 1-19 screened, 89 were enrolled in this single-center, open-label study. This study was not randomized.
718943|NCT02695524||
718944|NCT02695446||
718945|NCT02695420|Participants were enrolled at 31 research centers in Japan from 14 April 2016 to 16 December 2016.|Participants were randomized at a ratio of 1:1:1:1 to twice daily (BID) placebo, 25 mg, 25 mg->37.5 mg Target Dose, or 25 mg->50 mg Target Dose, respectively. Randomization was stratified by presence or absence of atrial fibrillation/flutter.
718946|NCT02695329||
718947|NCT02695290||This was an open-label, single-arm Phase IV study of afatinib in patients with stage IV or recurrent Non-Small Cell Lung Cancer who have poor performance status and whose tumors have the common epidermal growth factor receptor (EGFR) mutations, Exon 19 deletions or Exon 21(L858R) substitution mutations.
718948|NCT02694978|Participants with iron deficiency anemia (IDA), <12.0 grams (g) per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing and transferrin saturation (TSAT) <20% or Ferritin ≤100 nanograms (ng) per milliliter (mL) within 60 days of dosing and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.|
718949|NCT02694835|Subjects were recruited from 5 investigational sites located in the United States.|Of the 81 enrolled, 1 subject exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (80).
718950|NCT02694757||
718951|NCT02694744||
718952|NCT02694718|A total of 60 participants were enrolled in this study conducted from 30 March 2005 to 28 November 2006 at 6 centers in Switzerland.|
718953|NCT02694601||
718954|NCT02694562||Twenty MIRACLE III subjects were consented. Of these 20, eighteen (18) were enrolled and treated in the trial. Two subjects were not enrolled as they did not meet I/E criteria. These two subjects have been reported as screen failures.
718955|NCT02694549||
718956|NCT02694536||
718957|NCT02694523||A total of 684 subjects were enrolled; 79 subjects failed screening and are excluded from the analyses.
718958|NCT02694445||
718959|NCT02694328||
718960|NCT02694315||
718961|NCT02694198||
718962|NCT02693834|26 participants were screened for eligibility between March 2016 and October 2017 at two outpatient clinics (Pate Rehab, Dallas and Baylor Institute for Rehabilitation, Frisco) in Dallas, Texas. Out of the 26 screened participants, 3 did not meet inclusion criteria. 23 participants consented for the study.|Of the 23 consented participants 2 dropped out at baseline due to fatigue. 21 people completed the baseline measurements. 11 were randomized to DA AFO first week group, PLS AFO second week(1 lost to follow up) and 10 were randomized to PLS AFO first week, and DA AFO second week. 20 participants completed both arms.
718963|NCT02693743||
718964|NCT02693704||
718965|NCT02693691|The study enrolled a total of 239 subjects at 31 investigational sites in Germany, The Netherlands, and Ireland. The first subject was enrolled on 13 May 2016 and the last subject was enrolled on 29 March 2018. The last 12-month follow-up was completed on 19 March 2019. Data was collected until the database closure date, 28 June 2019.|Three of the 239 subjects enrolled withdrew before implantation was attempted. Of the 236 subjects who had an attempted implant, two subjects were not implanted. One subject was not implanted because there was a failure to meet screening criteria and the other subject experienced an AE during the implant procedure and was not implanted.
718966|NCT02693418||
718967|NCT02693171||
718968|NCT02693132||
718969|NCT02693106||
718970|NCT02693002||
718971|NCT02692859||
718972|NCT02692716|The study was conducted at 214 sites in 21 countries: Algeria (4), Argentina (6), Brazil (1), Canada (7), Denmark (5), Germany (10), India (16), Israel (8), Italy (7), Malaysia (10), Mexico (6), Netherlands (5), Poland (5), Romania (8), South Africa (9), Spain (9), Taiwan (4), Thailand (7), Turkey (9) and United Kingdom (9), United Stated (69).|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
718973|NCT02692703||The study included a 36-day screening period.
718974|NCT02692560||
718975|NCT02692495||
718976|NCT02692482||
718977|NCT02692417||
718978|NCT02692235|42 subjects volunteered to participate in the study. After the initial screening, 28 were included in the study (14 subject not meeting inclusion criteria) and were randomly assigned to either an L-carnitine (n=14) or a placebo supplementation group (n=14).|
718979|NCT02692209|The 298 breast screening and diagnostic cases selected for this study, were obtained from the FMSU2013-004A acquisition study. The statistician randomly selected cases to provide a distribution of density, finding types, etc.|"Reading radiologists independently read all 298 cases sequentially; first as an FFDM read, then as a FFDM + DBT read on the Aspire Bellus workstation.
~There was no washout, and all data below is entered correctly."
718980|NCT02692040|Recruited by Covance Clinical Research Unit, Leeds, UK|
718981|NCT02691936||
719015|NCT02688153||"All eligible subjects recruited were randomized to each arm/group as 1:1 ratio at start.
~Amongst randomized arm/group, three of the subjects randomized to the Edwards INTUITY group were converted to the control group and received commercially available surgical aortic heart valves."
718982|NCT02691741|Subjects were recruited from 15 study centers located in Australia (3), Brazil (3), Spain (3), Denmark (2), Colombia (2), United Kingdom (1), and the Netherlands (1).|Of the 215 enrolled, 26 subjects were exited as screen failures and 1 subject died prior to randomization. This reporting group includes all randomized subjects (188).
718983|NCT02691702||
718984|NCT02691572||
718985|NCT02691507||
718986|NCT02691494||Eligible participants were randomized in a 1:1:2 ratio to 1 of 3 treatment groups: placebo, elagolix 300 mg BID, or elagolix 300 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) once daily (QD).
718987|NCT02691468|One hundred and eight adult patients, aged between 18 and 75 years, American Society of Anesthesiologists (ASA) physical status 1 ~ 3 scheduled for elective thoracic surgery were enrolled.|Patients with emergency surgery, difficult intubation, poor lung function to accomplish one-lung ventilation (OLV) during surgery were excluded.
718988|NCT02691416|From July 2014 to January 2016, patients who were undergoing intracranial aneurysm surgery at hospital and consistent with the criterion of American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ,but without severe hepatic and renal dysfunction, coagulation disorder were recruited.|
718989|NCT02691260||
718990|NCT02691143|A convenience sample of who presented with acute non-complicated neck pain were recruited from an outpatient chiropractic clinic|
718991|NCT02691013||
718992|NCT02690974|This study was conducted in 32 study centers in Canada|Approximately 300 patients with HFrEF were planned for enrolling into the study. A total of 302 patients received at least one dose of LCZ696 and were included in the Full Analysis Set (FAS). The analysis of the primary endpoint was based on the FAS.
718993|NCT02690948||
718994|NCT02690935|The first patient was enrolled in the study on 05 March 2016 and the last study visit was on 29 November 2016.|
718995|NCT02690727||
718996|NCT02690701|Randomized Set consisted of all 91 participants who were randomly assigned to a treatment group|
718997|NCT02690207|Potentially eligible subjects who received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) studies were enrolled in this study.|8687 subjects were enrolled in this study and received Herpes Zoster sub-unit vaccine. Of these, 8434 subjects completed the trial and 253 subjects withdrew.
718998|NCT02690194||Control group data was not analyzed for all measures
718999|NCT02690181|Subjects were recruited from 1 site in Belgium.|All enrolled subjects completed the study.
719000|NCT02689973||
719001|NCT02689804||No significant events in the study that occur after participant enrollment, but prior to assignment of participants to an arm or group.
719002|NCT02689492|This was a multi-center, non-interventional (observational), prospective cohort study based mainly on newly-collected data for Chronic obstructive pulmonary disease (COPD) patients. No treatments were administered to the patients on the protocol basis, since this was a non-interventional study. The total number of enrolled patients was 401.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria were not met.
719003|NCT02689219|This protocol was a two cohort Phase II study. A Simon two-stage design was used. One cohort (CD30 negative/unknown) met the stopping rule for lack of efficacy at the first stage interim analysis. The first stage of the second cohort (CD30 positive) was not completed because the study was stopped early due to lack of funding.|
719004|NCT02689206|Participants on Hemodialysis (HD) with anemia associated with chronic kidney disease (CKD) switching from Erythropoiesis-Stimulating Agent (ESA) treatment were recruited in this randomized, dose-ranging study. Participants with hemoglobin (Hgb) values between 9.0- 11.5 grams per deciliter (g/dL) were considered as eligible for recruitment.|A total of 211 participants were screened; of which 108 were screen failures and 103 were randomized to receive at least one dose of either placebo or 10, 15, 25 or 30 milligrams (mg) of daprodustat (dapro). One participant who was randomized to the placebo group, erroneously received 25 mg dapro treatment throughout the 29-day treatment period
719005|NCT02689154|18 adolescents self-selected into the app intervention. During the intervention period the app participants did not attend the EMPOWER intervention. The app program did not require parental involvement.|Newly referred patients were pre-screened for eligibility prior to their first clinic visit. YFAS-c was utilized to screen for traits of food addiction. Inclusion criteria included age 12-18 years and positive YFAS-c. Exclusion criteria were: obesity co-morbidities known psychiatric illness or developmental delay, and the inability to read English.
719006|NCT02688933|The study was conducted at 100 sites in United States. A total of 980 participants were screened between 5 May 2016 and 16 February 2017, of whom 342 were screen failures. Screen failures were mainly due to exclusion criteria met.|A total of 638 participants were randomized in HOE901-U300 or Lantus, stratified by baseline HbA1c (<8 %,> =8%), frequency of basal insulin injections at Visit 1 (twice vs once daily), current continuous glucose monitoring (CGM) use at Visit 1(yes/no) and mealtime insulin titration algorithm (simple titration vs carbohydrate counting).
719007|NCT02688868||
719008|NCT02688842||
719009|NCT02688829||
719010|NCT02688764||
719011|NCT02688556||One subject in OTX-101 0.09% group, was never treated with study medication and is not included in any of analysis sets Additionally, because the subjects in the ITT analysis set were analyzed as randomized, one subject who erroneously received OTX-101 0.09%, was included in the Vehicle group for purposes of efficacy analysis.
719012|NCT02688387|This was a single dose, randomized, open-label, crossover study in healthy participants. A total of 112 healthy participants were randomized and received the study treatment. The study was conducted at a single center in the United Kingdom.|A total of 174 participants were screened, of which 59 were screen failures and 3 participants were reserve participants. Thus 112 participants were randomized. The study, was conducted in three parts: Part 1 (5 way crossover) and Parts 2 and 3 (A and B), followed 4 way crossover design.
719013|NCT02688218||
719014|NCT02688192|In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).|
719016|NCT02687919||
719017|NCT02687815||Of 595 participants assessed for eligibility, 192 finished run-in and were randomized.
719018|NCT02687542||
719022|NCT02687191||Not all the 15 pre-specified dose groups (possible doses based on Bayesian modified continual reassessment method [mCRM]) were expected to be studied. The actual doses were determined by mCRM and safety review. Study results were reported for the 6 actual dose groups allocated with participants.
719023|NCT02687165|4 patients were screened, but none was randomized|4 patients were screened, but no one was randomized
719024|NCT02687139||
719025|NCT02687126||
719026|NCT02686437||
719027|NCT02686164|Participants took part in the study at 4 investigative sites in the United States from 18 Apr 2016 to 16 Aug 2018.|A total of 51 participants were screened and enrolled, of which 21 were screen failures and 30 participants received the study treatment.
719028|NCT02686138||
719029|NCT02686034||37 patients were excluded from the study at the end of the 4-week Run-In/Observational period because they did not continue to meet the study eligibility criteria, were lost to follow-up, or they chose not to continue in the study.
719030|NCT02685956||
719031|NCT02685826|100 subjects screened for this study. The main cause of screen failures was failure of inclusion/exclusion criteria per protocol in 37 (37.0%) subjects while 7 (7.0%) subjects failed screening for other reasons (mainly due to the Full Clinical Hold placed by the FDA).|A total of 56 subjects were enrolled and treated over 24 study sites.
719032|NCT02685566|The 100 breast screening and diagnostic cases selected for this study, were obtained from the FMSU2013-004A acquisition study. The statistician randomly selected cases to provide a distribution of density, finding types, etc.|Each radiologist read all 100 cases as FFDM only and FFDM+DBT(100 cases multiplied by 2 modalities = 200 reads) with a 4 week washout period between the 2 sessions.
719033|NCT02685488||
719034|NCT02685436|infants referred to the pediatric pulmonology unit at MUCH for evaluation because of recurrent or persistent wheeze were evaluated for the presence of GERD at gastro-enterology and hepatology unit.|
719035|NCT02685293|Subjects with moderate to severe chronic obstructive pulmonary disease (COPD) were enrolled into this 2-period, 2-treatment, crossover study from 09 December 2016. The study was terminated early on 20 June 2018.|Subjects were randomly assigned, in a 1:1 ratio, to receive either Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) then Placebo MDI or Placebo MDI then GFF MDI in two 7-day treatment periods, separated by a washout period of between 7 and 21 days.
719036|NCT02685202||
719037|NCT02685072||
719038|NCT02685033||
719039|NCT02685007|Participants took part in the study at 7 investigative sites in Austria from 05 April 2016 to 14 August 2017.|Participants planned for laparoscopic surgery in the field of gynecology, urology or visceral surgery were enrolled in this study to use pre-rolled TachoSil according to the local Summary of Product Characteristics (SmPC) based on physician decision and the data was collected under routine standard of care.
719040|NCT02684981|This is an observational study. Total 9472 patients with Non-Valvular Atrial Fibrillation (NVAF) were enrolled in the study using Vitamin K antagonist (VKA) therapy prior to being switched to Pradaxa® and newly diagnosed with NVAF and initiated Pradaxa® or VKA. Patients were followed up for observational period of approximately 6 months.|All patients were screened for eligibility. All enrolled patients met all implemented inclusion/exclusion criteria. Out of 9472 enrolled patients, 7 patients with unknown study treatment were not included in the main analysis set. Total 9465 patients were included in the main analysis set and started the study.
719041|NCT02684942|The study design is cross-over in female outpatients with cervical cancer (age, 20-80 years) stage IB-IVB treated with four fractions of brachytherapy from June 2013 to September 2014 were enrolled in the study.|Forty patients with cervical cancer were enrolled in the study. The exclusion criteria were prior pelvic brachytherapy and a history of allergy to meperidine, fentanyl, or benzodiazepine and none were subsequently excluded.
719042|NCT02684630||131 volunteers signed consent and were enrolled, but 3 were screen fails and therefore did not participate in the study
719043|NCT02684604||
719044|NCT02684591||
719045|NCT02684435||
719046|NCT02684396|Participants took part in the study at 1 investigative site in the United States from 19 August 2014 to 08 July 2015.|Healthy Volunteers were enrolled in 1 of 6 treatment groups, once a day placebo, TAK-648 0.05 mg, 0.15 mg, 0.35 mg, 0.7 mg or 0.85 mg.
719047|NCT02684370||A total of 560 subjects were enrolled; 54 subjects failed screening and are excluded from the analyses.
719048|NCT02684357||A total of 577 subjects were enrolled; 86 subjects failed screening and are excluded from the analyses.
719049|NCT02684344||
719050|NCT02684279||A total 533 subjects were enrolled in this study. Five subjects did not receive any dose of study medication.
719051|NCT02684188|We recruited participants from among patients admitted to Saint Patrick Hospital, a regional referral hospital, from one of four counties. All four were non-metropolitan counties and three of the counties met the criteria of being a frontier county (population of less than 6 people per square mile).|
719052|NCT02684097||
719053|NCT02683954|This study was conducted in Ain Shams University Maternity Hospital, during the period from December 2014 till October 2015. After approval of the research and ethics committee and, sixty patients were admitted to the wards to undergo laparoscopy for various indications and were included in this study.|
719054|NCT02683928||
719055|NCT02683876||
719056|NCT02683785|This was a multi-center, double-blind, placebo-controlled study to investigate the efficacy and safety of GSK3196165 in participants with inflammatory hand osteoarthritis. The study was conducted in five countries in Poland, United Kingdom, Netherlands, Germany and United States.|A total 121 participants were screened of which 77 were screen failures and 44 participants were enrolled in the study.
719057|NCT02683772||43 patients consented for this study. One patient did not meet criteria. 42 patients were randomized and began the first study PSG night. 3 patients were found to be ineligible due to I/E criteria not met. Site erroneously placed patient on ST mode for one of the PSG study nights. Thus, there were 38 patients that were analyzed.
719058|NCT02683746|This repeat-dose study of albiglutide was conducted at 153 sites in the United States (US). A total of 624 participants with type 2 diabetes mellitus (T2DM) were screened; of these 316 were screen failures and 308 were randomized to receive albiglutide liquid drug product or lyophilized drug product in a 1:1 ratio.|
719059|NCT02683707||
719060|NCT02683668|Forty-four subjects (23 male) with mild-to-moderate COPD (GOLD stage I-II, FEV1 67.8% of predicted) using DPI-HandiHaler (18µg tiotropium daily) for at least 3 months, but with ongoing symptoms or exercise limitation (COPD Assesment Test (CAT) score >10) participated in the study. 1 failed to complete|
719061|NCT02683577|This was an open-label study conducted at 2 investigational sites, one in Romania and one in the Republic of Moldova. Subjects were enrolled to the study from 08 February 2016 (first subject enrolled) until 07 July 2016 (last subject completed).|"Subjects enrolled into 3 hepatic functional groups:
~Healthy control subjects with normal hepatic function
~Mild hepatic impairment (HI) subjects (Child-Pugh [C-P] class A)
~Moderate HI subjects (C-P class B).
~C-P score was summed from 5 clinical assessments of liver disease; each measure scored 1-3, with 3 indicating most severe derangement."
719062|NCT02683525||
719063|NCT02683421||
719064|NCT02683174||
719065|NCT02683161||
719066|NCT02683109|Definition: Open-Label Treated Set (OLTS): This patient set includes all patients who signed the informed consent and were dispensed open-label study medication during the run-in period prior to randomisation and were documented to have taken any dose of this medication.|Definition: Randomised Set (RS): This patient set is nested within the OLTS and includes all patients who signed the informed consent form and were also randomised, regardless of whether the patient was treated with study medication or not.
719067|NCT02683083||
719068|NCT02682823||
719069|NCT02682602||
719070|NCT02682563||
719071|NCT02682498||
719072|NCT02682381|Study was conducted at 27 study centers in the United States, Belgium, Canada, the United Kingdom, Finland, Germany and Italy between 03 June 2016 (first participant first visit) and 18 August 2017 (last participant last visit).|Overall, 59 participants were enrolled; 50 in the teduglutide treatment arm (24 participants in the 0.025 milligram per kilogram per day (mg/kg/day) dose group and 26 participants in the 0.05 mg/kg/day dose group)and 9 in the standard of care arm.
719073|NCT02682264|There were 609 subjects who were rolled over (i.e., enrolled) from the two Phase 3 pivotal studies (CB-03-01/25 [NCT02608450] and CB-03-01/26 [NCT02608476]) into this long-term, safety study. However, two (2) subjects in the original vehicle cream were not treated with test article and thus were excluded from the study population (Safety set).|
719074|NCT02682069||
719075|NCT02682056|Participants were enrolled between December 2017 and January 2018 from the Emory Children's Center and Children's Healthcare of Atlanta, in Atlanta, Georgia.|
719076|NCT02682030|Patients were recruited internally at Cedars-Sinai Medical Center ALS multidisciplinary clinic.|5 participants met inclusion criteria and were enrolled into the study. One participant was randomized to the Treatment Group A HFCC Only arm while 4 participants were randomized to the Treatment Group B HFCC + Cough Assist Arm.
719077|NCT02681809||
719078|NCT02681757||
719079|NCT02681614||
719080|NCT02681510|"Participants were recruited via Facebook ads contextually tagged to appear only to adults in the Madison, WI area who had liked or posted about smoking."|
719081|NCT02681458||
719082|NCT02681172|This was a Phase IV, multi-center study which was conducted in an outpatient setting documenting routine clinical care in the Centres Mémoire Ressources et Recherches (CMRR). Subjects were recruited in 18 active centers in France.|
719083|NCT02681094|The study was conducted at 119 sites in 6 countries: Canada, Czech Republic, Germany, Mexico, Russia, and United States (US). Approximately 900 participants were to be randomized. Participants with Type 2 Diabetes (T2DM) inadequately controlled on metformin alone were randomized in this study.|All participants had screening (Visit 0) at 1 week prior to enrolment to screen the eligibility based on non-fasting sample of Glycated haemoglobin (Hb A1c); results of HbA1c determined enrolment based on inclusion/exclusion criteria. An abbreviated informed consent was signed and review of concomitant or other medications/therapies were performed.
719084|NCT02680847||
719085|NCT02680834||All subjects participated in a two week run-in phase. The treatment included MLB which was worn 24 hours a day except during clinic visits. The run-in phase was intended to assess the subject's initial response to standard of care treatment using MLB before receiving treatment with the investigational device.
719086|NCT02680756||A total of 462 subjects were screened; of these, 212 subjects were not randomised (202 screening failures and 10 not assigned). 250 subjects (54% of the screened population) were randomised: 125 subjects to the ferric maltol group and 125 subjects to the IV iron group.
719087|NCT02680665||
719088|NCT02680639|Participants were in enrolled from a single site in Pittsburgh PA. The study opened Mid 2015 with first enrollment November 2015 and continued into August 2016.|
719089|NCT02680457||Total number of patients: 12 in a crossover intervention. Interventions: 2. Washout period before the cross-over intervention. Protocol violations were detected at the end of the study in patients of both groups
719090|NCT02680301||
719091|NCT02680158||
719092|NCT02680145||
719093|NCT02680054||Study was closed before target could be reached due to exhaustion of eligible participants
719094|NCT02680041|The study was conducted between 01 June 2016 (first patient, screening visit) and 01 November 2017 (last patient, last contact) at 17 sites in the USA. Overall 17 sites were initiated, of which 15 sites enrolled patients.|
719095|NCT02680002|Participants were screened and enrolled at 6 sites in the US.|
719096|NCT02679976||A total of 30 subjects were enrolled into this study. Subjects were stratified as either Hyperope or Myopes using a 1:1 allocation. All enrolled subjects completed the study.
719097|NCT02679911|Subjects at screening had a mycological sampling of affected great toenail and for inclusion subjects shoud have both direct microscopy and culture results positive at Baseline|
719098|NCT02679807||All volunteers who signed consent were considered enrolled in the study per UVA IRB policy. 334 of these 380 volunteers were randomized to treatment after pre-treatment screening was complete.
719099|NCT02679755||252 participants were assigned to treatment at 20 sites in India and Australia (100 in India, 152 in Australia)
719219|NCT02667457|The study was conducted at single center in Canada.|A total of 39 participants were screened and enrolled to the study, of which only 36 participants were administered with investigational imaging product. All 36 treated participants completed the study.
719100|NCT02679729|Phase 1, first-in-human (FIH), single-blind, placebo-controlled, single ascending dose (SAD), sequential dose group study in healthy male participants and female participants of non-childbearing potential at 2 study centers (EPCU Baltimore and EPCU Los Angeles). The study comprised of Part A and Part B.|The study consisted of a screening period (Days -28 to -1).
719101|NCT02679690||
719102|NCT02679573||860 subjects were planned to be enrolled in the study but 859 are included in the ITT population. One subject mistakenly was randomized into the IXRS but did not provide informed consent; therefore, this subject was not included in the ITT population.
719103|NCT02679469||
719104|NCT02679287||103 participants signed informed consent and were assessed for eligibility.10 were excluded prior to randomization (7 did not meet inclusion criteria, 2 declined to participate, 1 lost to followup). 93 participants were randomized and assigned to groups.
719105|NCT02679274||
719106|NCT02679235||
719107|NCT02679222||
719108|NCT02679066||
719109|NCT02678923||Participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up intravascular ultrasound (IVUS) assessment were included in the modified intent-to-treat (mITT) population (primary/secondary analyses).
719110|NCT02678676|Participants took part at 228 sites in 18 European countries including Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Latvia, Lithuania, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, and the United Kingdom from 02 November 2004 to 10 March 2015.|Participants with a historical diagnosis of Type 2 diabetes mellitus (T2DM) who were previously treated with pioglitazone or placebo in the PROactive study (NCT00174993) were enrolled in this observational study according to their originally assigned treatment group.
719111|NCT02678442||
719112|NCT02678416|A total of 79 participants were enrolled in the study. 12 participants in Part 1 and 66 participants in Part 2 were randomized to sequence, and received at least one dose of the study treatment.|One participant in Part 2 was randomized but discontinued without receiving treatment due to an adverse event.
719113|NCT02678390||
719114|NCT02678286||
719115|NCT02678039||
719116|NCT02678000|All subjects (N=11) who enrolled in in PART 1 completed the study : LHW090 (N=7) and placebo (N=4). Of all subjects (N=73) in PART 2, a total of 69 subjects completed and 4 subjects discontinued.|All subjects (N=11) who enrolled in in PART 1 completed the study : LHW090 (N=7) and placebo (N=4). Of all subjects (N=73) in PART 2, a total of 69 subjects completed and 4 subjects discontinued.
719117|NCT02677896|Participants with metastatic hormone sensitive prostate cancer (mHSPC) were enrolled in 204 study sites worldwide.|The randomization was stratified by volume of disease (low vs high) and prior docetaxel therapy for prostate cancer (no prior docetaxel, 1 to 5 cycles, 6 cycles).
719118|NCT02677844|Dose escalation study with 2 cohorts, participants in cohort 1 were randomized to 1 of 4 sequences & participants in cohort 2 were randomized to 1 of 3 sequences. Cohort 1 had periods 1 to 4 with at least 5 days washout between each dose, Cohort 2 had periods 4(DDI) to 7 with at least 8 days washout between each dose.|
719119|NCT02677779||
719120|NCT02677766||
719121|NCT02677753||
719122|NCT02677740||
719123|NCT02677714|The study was conducted at single center in Canada.|
719124|NCT02677623||10 consented subjects were excluded prior to randomization. 8 had completed their surgery during a period of study suspension and 2 ended up not proceeding with surgery.
719125|NCT02677493||
719126|NCT02677428|Participants were recruited from two VA Medical Centers in New England between December 2015 and December 2018. 32 participants who consented to the study did not log into the study website and were thus excluded from analysis.|
719127|NCT02677220||
719128|NCT02677116||Completers include the participants who died due to any cause or disease progression, alive and on study at conclusion, but off treatment.
719129|NCT02676895|Out of the 74 enrolled subjects, 2 subjects were allocated numbers but were not administered the study vaccine, hence they did not start the study.|
719130|NCT02676882|Recruitment period: 1/24/2017 through 3/5/2018 Recruitment methods: Medical clinics, womensmentalhealth.org, other online recruitment sources, flyers in public locations, database of previous patients and research participants at the Center for Women's Mental Health at MGH|Potential subjects were screened by phone and if eligible attended a baseline screening visit at which they consented to further eligibility assessment for each of two groups. If after consent they failed to meet eligibility criteria, they were considered enrolled per IRB guidelines, but were not assigned to a group to start study medication.
719131|NCT02676843||
719132|NCT02676466||
719133|NCT02676375||
719134|NCT02675998||
719135|NCT02675907||
719136|NCT02675764||
719137|NCT02675751||235 subjects were consented in the study, of which all 167 subjects have both eyes treated for a total of 334 treated eyes.
719138|NCT02675634|The subjects were recruited through the Coloplast A/S database and from hospital sites|
719139|NCT02675543||
719140|NCT02675517|1737 patients were treated. Of these 1578 patients had both visits documented as well as filled in all questionnaires, thus being evaluable for analysis of primary and secondary endpoints .|All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered to trial drug if any of the specific entry criteria was violated.
719141|NCT02675426|"Participants were randomized at 150 centers in 35 countries in North America, eastern and western Europe, Asia, South America, Australia, New Zealand, and South Africa.
~The study had a 12-week placebo-controlled, double-blind period (Period 1), and an ongoing 5-year double-blind extension (Period 2). Results for Period 1 are reported."|Participants were randomly assigned in a 1:1:1 ratio to 15 or 30 mg upadacitinib or placebo. Randomization was stratified by prior exposure to biologic disease-modifying anti-rheumatic drug (bDMARD) and geographical region. Participants assigned to placebo were switched to 15 or 30 mg upadacitinib at week 12 according to randomization assignment.
719142|NCT02675231||In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
719146|NCT02674659|We initiate this project from February 10th, 2016 until September 23rd, 2016. All the subjects (post coronary artery bypass graft operation) were collected from the National Cardiovascular Center Harapan Kita.|There is no specific run-in period for every patient enrolled in this study. If they meet the inclusion criteria, they will be randomly assigned to the intervention or control group.
719147|NCT02674633||Participants who met full criteria for ADHD at Screening and who the PI believed were not optimally treated with current medication were eligible to washout their medication regimen. For those electing to washout, treatment was discontinued between 7 and 3 days prior to their scheduled Baseline Visit.
719148|NCT02674568||A total of 342 participants were enrolled; 3 participants were not dosed.
719149|NCT02674477||
719150|NCT02674412||
719151|NCT02674386|This study included participants from studies A4091056 (NCT02697773), A4091057 (NCT02709486) and A4091058 (NCT02528188) who had undergone a total joint replacement (TJR) surgery of knee, hip, or shoulder. During this study, if participant underwent an additional TJR surgery, then data for that additional TJR surgery was also assessed.|Pre-specified intent of this study was to compare results regardless of treatment group/doses in parent studies and also to report data for overall (combined participants from all parent studies).
719152|NCT02674334|Participants were informed of the study in the Orthopaedic clinic at the visit prior to surgery. The consent form and pre- and post-testing using the Mini Mental State Examination (MMSE) was reviewed. Following consent, the baseline MMSE was administered. A score below 24 disqualified participants. Recruitment began October 2012 and ended May 2013.|Excluded reasons: anesthesiologist availability; surgery started early; illiteracy; less than 24 on the pre-operative MMSE; supine and BCP; no surgery; surgery delayed; operating suite could not accommodate NIRS monitor; data not recorded; previous difficult intubation; surgeon in two operating suites simultaneously; not needed, quota met.
719153|NCT02674204||
719154|NCT02674061||These results are based on a database cutoff date of 18-September-2019, at which time 91 participants were ongoing in the study.
719155|NCT02673944||
719156|NCT02673918|We had pre-defined recruitment period and not a sample size goal. The recruitment period was 10 weeks for part 1 of the study (recruiting women within 8 weeks of surgery for breast cancer) and 20 weeks for part 2 (recruiting women within 6 weeks of completing radiation therapy for breast cancer).|
719157|NCT02673684||
719158|NCT02673619|This was a double blind, repeat dose, randomized, parallel group, placebo controlled study to examine the clinical effect, pharmacokinetics, safety and tolerability of topically applied umeclidinium (UMEC) for 28 days, to the palms, in participants with primary palmar hyperhidrosis. The study was conducted at six centers.|Participants were randomized in 4:1 ratio (UMEC: vehicle) to receive UMEC 1.85 percent or vehicle in higher dose cohort and UMEC 1.15 percent or vehicle in lower dose cohort. A total of 140 participants were screened, of which 82 failed screening and 58 participants were randomized into the study.
719159|NCT02673541||
719160|NCT02673515|After interviewing 462 adults for study eligibility based on previously set inclusion and exclusion criteria we have selected 60 representative study participants for the randomized controlled trial.|
719161|NCT02673489||Of the 106 subjects enrolled, 78 participants entered the treatment period and received study treatment; 28 participants were enrolled but did not enter the treatment period. 26 were due to no longer meeting study criteria; 1 was due to poor/non-compliance (missed Day 1 visit); and 1 was other (missed screening window).
719162|NCT02673372||
719163|NCT02673333||
719164|NCT02673203||
719165|NCT02673138||
719166|NCT02672852||Part A1: double-blind (DB) risankizumab or placebo (Weeks 0,4). Part A2 (Week 16) DB placebo to DB risankizumab; risankizumab continued risankizumab. Part B (Week 28) risankizumab responders rerandomized to DB risankizumab/placebo; risankizumab nonresponders continued risankizumab. Week 32: rerandomized relapsed switch risankizumab.
719167|NCT02672553|All eligible subjects recruited were randomized to each arm/group as 1:1 ratio at start.|Three (3) of the subjects randomized to the Edwards INTUITY group were converted to the control group and received a commercially available surgical aortic heart valve via MIS and therefore these three (3) subjects could not be accurately categorized into the MIS-AVR or FS-AVR category and were excluded from the as intended (AI) cohort.
719168|NCT02672514||
719169|NCT02672423||A 2- and 3-period crossover study conducted in 3 parts, with Part A followed by Parts B and C. Participants received single oral doses of abemaciclib on 2 separate occasions in Parts A and C and on 3 separate occasions in Part B.There was a washout interval of at least 16 days between periods.
719170|NCT02672176|Participants were recruited from three Primary Care Clinics at UC Davis Health|
719171|NCT02672111||One patient enrolled in the study but did not receive CAM2038
719172|NCT02672033|From 10/2015 to 04/2018, 2 subjects were consented into the trial.|Eligibility screening by the Jonsson Comprehensive Cancer Center Data Safety Monitoring Board. Subjects undergo 5 fractions of hypofractionationated Intensity Modulated Radiation Therapy (IMRT) over 1 week with simultaneous integrated boost to gross disease.Subjects then undergo pleurectomy/decortication within 14 days after completion of IMRT.
719173|NCT02671760||
719174|NCT02671500|Participants were enrolled at study sites in Asia. The first participant was screened on 19 April 2016. The last study visit occurred on 27 March 2018.|437 participants were screened.
719175|NCT02671461||16 participants were enrolled; 15 were randomized; 14 were treated. 1 participant was not randomized because the interactive voice response system did not work at the time of enrollment
719176|NCT02671422|Non-interventional study based on newly collected data in patients with Non-Small Cell Lung Cancer of adenocarcinoma tumour, who, for the first time, received Vargatef® as part of the routine treatment according to the approved label (new users design), to explore whether genetic or genomic markers could be used to predict Overall Survival.|Only subjects that met all the study inclusion criteria were to be entered in the study. All subjects were free to withdraw from the non-interventional study at any time for any reason given.
719177|NCT02671266||
719178|NCT02671136||
719179|NCT02671032||
719180|NCT02670928|This study was conducted in the following jurisdiction: Russia (2 centers).|
719220|NCT02667288||
719221|NCT02667275||
719222|NCT02667236||
719181|NCT02670915|The trial was conducted at 150 sites in 17 countries(number of sites with screened/randomised subjects)-Bulgaria: 4/4; Czech Republic: 6/6; Estonia: 2/2; Finland: 3/3; Germany: 6/6; India: 7/7; Israel: 6/6; Italy: 5/5; Japan: 34/34; Latvia: 1/1; Lithuania: 1/1; Poland: 4/4; Russia: 11/11; Serbia: 4/4; Turkey: 7/7; Ukraine: 9/9; United States: 40/39|12-week run-in period: Participants were switched from previous insulin treatment to insulin degludec once daily, and mealtime NovoRapid®/NovoLog®. Insulin degludec treatment was optimised on a weekly basis to the pre-breakfast glycaemic target of 4.0-8.0 mmol/L. Out of 834 participants, who started the run-in period, 57 were run-in failures.
719182|NCT02670811||Participants who were eligible were asked to sign informed consents. Afterwards all baseline measurements were taken two weeks before randomization and group formations. Subjects who did not fulfill the inclusion criteria were explained why they were not eligible for this study.
719183|NCT02670629|"The patients in this research study were those admitted to the Emergency department of the Hospital Universitario José Eleuterio González between July 1, 2014 and December 1, 2015 with a diagnosis of a acute completely displaced distal radius fractures who matched our inclusion criteria."|Patients who had additional fractures or injuries, as well as those who sustained an open distal radius fractures were excluded from the trial before the assignment of groups. Other exclusion criteria included bone diseases, pathological fractures and chronic fractures.
719184|NCT02670551||Total 782 participants were screened for eligibility; 488 participants randomized to receive double-blind treatment; 480 participants received at least 1 dose of double-blind treatment (Safety Population) and 474 participants had at least 1 postbaseline Montgomery-Åsberg Depression Rating Scale total score assessment (Intent-to-Treat Population).
719185|NCT02670538||
719186|NCT02670473||
719187|NCT02670343||
719188|NCT02670330|152 participants with epidermolysis bullosa (EB) were enrolled between 9 June 2015 and 5 July 2017 in this open-label, multi-center extension study. All enrolled participants had previously completed Study SD-005 (NCT02384460).|Analysis groups were defined based on prior treatment in Study SD-005: 77 participants who received placebo were allocated to the 'Placebo to Zorblisa™ (SD-101-6.0)' group and 75 participants who received SD-101-6.0 were allocated to the 'SD-101-6.0 to SD-101-6.0' group. All participants received SD-101-6.0 upon enrolling in Study SD-006.
719189|NCT02670083|The study was conducted at 249 centers in 30 countries.|A total of 813 participants were enrolled at 249 centers. 4 participants did not receive any study treatment meaning that the modified intent-to-treat and safety populations both consisted of 809 participants.
719190|NCT02669940||
719191|NCT02669914|The study opened to participant enrollment on 09/12/2016 and closed to participant accrual on 11/16/2017.|
719192|NCT02669862||
719193|NCT02669849|Participants were randomized to receive a single 9-mg dose of VX-210 or a placebo (buffer solution). A single 3-mg dose of VX-210 in fibrin sealant was initially included but was subsequently removed during the study through a protocol amendment. The 3-mg arm was not analyzed for primary and secondary efficacy and pharmacokinetic analysis.|A total of 70 participants were randomized, out of which 67 participants received the study drug.
719194|NCT02669784||
719195|NCT02669758|Subjects who completed the 4-week treatment period of the antecedent study, ALK3831-A305, were eligible to be enrolled in Study ALK3831-A306 within 7 days of their last study visit in ALK3831-A305.|A total of 4 subjects enrolled but were not dosed. Three subjects were lost-to-follow-up prior to receiving study drug, and one subject was not compliant with study drug. A total of 277 patients were administered at least one dose of ALKS 3831 and were included in the safety population.
719196|NCT02669667|The study was conducted from 18Feb2016 to 12Jun2017 in United States and United Kingdom.|"A total of 124 participants were enrolled in the study; of which 80 participants were screen failures. Forty-four participants were randomized to MEDI9314 or placebo in 7 treatment groups."
719197|NCT02669615||
719198|NCT02669433||484 participants signed consent and were screened for participation. Of these, 306 entered a 2-week single-blind placebo run-in period with treatment with placebo qd. There was an overlap between the participants from the run-in period and the participants that were randomized during the treatment period.
719199|NCT02669407|Recruited patients hospitalized for acute decompensated heart failure (ADHF) at Duke University Hospital between April 2017 and May 2018.|
719200|NCT02669329||
719201|NCT02669264||
719202|NCT02669095||A total of 150 subjects were enrolled in this study. All subjects enrolled into the study were dispensed a study lens. Of the dispensed subjects 146 completed the study and 4 subjects were discontinued.
719203|NCT02669082|Participants took part in the study at 7 investigative sites in Japan from 09 May 2017 to 31 January 2018.|Participants with a diagnosis of Major Depressive Disorder (MDD) with Insomnia were enrolled in 1 treatment arm: Ramelteon 8 mg.
719204|NCT02669043||
719205|NCT02669017||Participants were screened at 11 sites in 3 countries.
719206|NCT02668952||
719207|NCT02668822||
719208|NCT02668783||
719209|NCT02668640||All participants who received at least one dose of adalimumab during the study
719210|NCT02668432||
719211|NCT02668302|A total of 45 patients were recruited at one clinical site between November 9, 2015 and May 24, 2016, of whom 40 met final eligibility.|Participants underwent endoscopic sinus surgery, including bilateral ethmoidectomy with middle meatal antrostomy. Concurrent septoplasty and surgical treatment of the other paranasal sinuses were also permitted. Participants returned at 7 days post-op and those meeting final eligibility underwent baseline assessment and group assignment.
719212|NCT02668198||
719213|NCT02667951||
719214|NCT02667912||
719215|NCT02667821|Twenty patients were recruited from the campus-teaching clinic located at the Canadian Memorial Chiropractic College. Included were adults aged 18 years and older with chronic grade II mechanical neck pain that had been prescribed cervical manipulation for treatment of their condition|
719216|NCT02667704||This is open-label, mono-center clinical trial in healthy male subjects applied a fixed sequence, two-treatment, two- period crossover design. All subjects were to undergo 2 trial periods in a fixed sequence, receiving reference treatment (R) in Period 1, and test treatment (T) in Period 2. A wash-out between Periods 1 and 2 was not mandatory.
719217|NCT02667639||
719218|NCT02667626||
719225|NCT02666664|A total of 2230 participants were randomized 2:1 to either bempedoic acid or placebo. One participant was randomized to bempedoic acid treatment, but never received any dose of investigational medicinal product (IMP) i.e. study drug.|The study consisted of 2 periods: a 2-week screening period and a 52-week double-blind, randomized treatment period.
719226|NCT02666560|Recruitment occurred at an NHS FoundationTrust between March to April 2015. Twenty-six children with Cerebral Palsy who were currently on the paediatric physiotherapy caseload met the inclusion criteria, so were invited to participate. A total of nineteen children chose to participate in this research project.|
719227|NCT02666430||
719228|NCT02666352|Participants with moderate hepatic insufficiency (HI), severe HI, and healthy controls were recruited at 2 study centers in the United States.|
719229|NCT02666222||
719230|NCT02665741||
719231|NCT02665728||
719232|NCT02665689|The recruitment has been stopped prematurely in August 2018 by the sponsor after the enrolment of four patients because the enrollment pace was far below target.|Screening period of seven days prior to randomization.
719233|NCT02665468||
719234|NCT02665455||Eighty-three (83) participants were consented. Nine of the 83 participants withdrew from the study on or before Visit 1 and before the device was worn or used. All 74 participants that wore a sensor are included in the analysis.
719235|NCT02665364||"The number of participants enrolled is the number of participants who signed informed condent form.
~One subject was randomized in IFN-K group and did not receive IFN-K. A total of 185 subjects were randomized and 184 subjects were treated : 91 subjects received IFN-K and 93 subjects received placebo."
719236|NCT02665286||
719237|NCT02665273||
719238|NCT02665260||A total of 6 subjects met exclusion criteria for having greater than 50 molluscum contagiosum lesions at screening.
719239|NCT02665221||
719240|NCT02664987||
719241|NCT02664961||
719242|NCT02664922||
719243|NCT02664610||
719244|NCT02664532||
719245|NCT02664415|This study was conducted at the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. Participants were recruited between 9 August 2016 and 9 January 2017, from ongoing Acute HIV Infection (AHI) cohorts and received ART during AHI via a separately-funded protocol (clinicaltrials.gov NCT00796263).|Twenty-three participants were enrolled, 4 were withdrawn prior to randomization because of the unavailability of study product in-country, and 19 were randomized with 5 assigned to placebo and 14 to VRC01. One VRC01 recipient experienced severe generalized urticaria during the first study infusion and did not complete the study.
719246|NCT02664363||
719247|NCT02664311|September 2013-January 2014 at Beth Israel Deaconess Medical Center|
719248|NCT02664272||
719249|NCT02664220|Of 372 subjects consented, 100 were enrolled as these subjects had perforated appendicities|
719250|NCT02664181||
719251|NCT02663882||
719252|NCT02663817||
719253|NCT02663752|Study has been discontinued because of low patient recruitment.|
719254|NCT02663687|The study was conducted at a single center in the United States between 19 February 2016 (first participant first visit) and 05 December 2016 (last participant last visit).|A total of 48 participants were screened, randomized and received at least one dose of treatment.
719255|NCT02663674|Recruitment occurred between Feb 2016 and May 2018 at community locations in Coccidioides-endemic areas. Participants were adults presenting with community acquired pneumonia (CAP) whose health care provider had made the decision to treat with an antibacterial.|
719256|NCT02663453|This study enrolled preterm infants who required parenteral nutrition for at least 7 days from 2 academic medical centers in Bangkok. The last patient completed in December 2015|
719257|NCT02663232||
719258|NCT02663128|To obtain representative age-related data, attempts were made to enroll at least 6 participants who were >55 years of age.|Participants were randomized to 1 of 6 treatment sequences over 3 treatment periods that were 7 days long with a 7-day washout period between doses. Participants were either in a fasted state or fed state. Sequences contain a Reference (Fasted) dose; Test (Fasted) dose, and Test (Fed) dose: R (Fast)/ T (Fast)/ T (Fed), respectively.
719259|NCT02662764||
719260|NCT02662608|Study recruitment was limited to single participant compassionate use in December 2015.|
719261|NCT02662569|Participants were enrolled at 102 study centers and randomized at 98 centers in Argentina, Brazil, Canada, China, Colombia, France, Republic of Korea, Russian Federation, Turkey, and the United States from 14 April 2016 to 28 July 2017.|Participants who met eligibility criteria and completed at least 4 weeks of lipid stabilization on atorvastatin 20 mg daily were randomized in a 1:1:2:2 ratio to receive placebo every 2 weeks (Q2W), placebo once a month (QM), evolocumab Q2W, or evolocumab QM. Randomization was stratified by entry statin therapy and geographic region.
719262|NCT02662556||
719263|NCT02662387||
719264|NCT02662244|Thirty-three subjects seeking treatment for biopsy-proven BCC that did not meet the criteria for Mohs surgery were recruited from the clinic|
719265|NCT02662036||
719266|NCT02661828|Participants were recruited from January 2016 through March 2017.|Of the two participants who signed consent, one subject began study participation for which data were collected.
719267|NCT02661815|Patient were recruited in medical clinics from 03/28/2016 to 01/17/2017, the first patient was enrolled on 06/15/2016.|
719268|NCT02661737||
719269|NCT02661594|Forty (40) healthy, non-elderly, Caucasian and Japanese, male or female subjects were planned to enter the study. At least 10 subjects were to be Japanese and at least 40% of subjects for both races were to be male.|Forty (40) healthy subjects entered the study. One subject voluntarily withdrew after Period 1 (moxifloxacin 400 mg) and another subject was withdrawn due to severe non-compliance with the protocol after receiving APD421 5 mg and 40 mg.
719270|NCT02661490|Participants took part in the study at 10 investigative sites in United States from 1 February 2016 to 31 October 2017.|Healthy elderly volunteers were enrolled and randomized in 1:1:1:1 ratio in 4 arm groups to receive either one or two doses of one of the 2 formulations (A or B) of norovirus (NoV) GI.1/GII4 bivalent virus like particle (VLP) vaccine or placebo. Healthy young adults received both placebo and formulation A.
733184|NCT01586026||
719271|NCT02661256|Recruitment Period: September 2014- August 2015. All participants were recruited from the Neonatal Intensive Care Unit (NICU) at Winthrop University Hospital, Mineola, NY.|Chart review- 26 preterm infants on nCPAP. Weaned off nCPAP before approaching-10. Excluded- 4 (h/o upper airway anomalies, brain injury, etc.). Eligible-12. Declined consent -5. Consented-7. Screening and VFSS completed-7. Analyzed-7. None of the enrolled participants were excluded from the trial before assignment to groups.
719272|NCT02661178||79 healthy subjects were randomized and received study drug. Protocol Enrollment reflects the total number of participants enrolled in both Part 1 (63 participants) and Part 2 (16 participants).
719273|NCT02661126|In Part 1, adults with moderate renal impairment (RI; determined by estimated glomerular filtration rate [eGFR]), and healthy participants, were recruited at 2 sites in the US. Part 2 was intended to enroll severe RI participants but was not conducted based on results of a planned interim analysis of Part 1 data.|
719274|NCT02661061|Participants were inpatients at St Patrick's Mental Health Services admitted for treatment of an acute depressive episode with a previous history of depression|Participants were randomised from n=28 participants in an observational phase, all of whom were receiving inpatient treatment for recurrent depressive disorder. Participants were monitored weekly for response to treatment and those who responded were invited to be randomised.
719275|NCT02660983|Participants took part in the study at 32 investigative sites in Korea from 05 August 2013 to 21 December 2018.|A total of 425 participants were screened, of which 123 were screen failures and 302 were enrolled and randomized to receive study treatment. For Double Blind (DB) Phase both efficacy and safety data is presented while for Open Label Extension (OLE) Phase, only safety data is presented.
719276|NCT02660918||
719277|NCT02660853||
719278|NCT02660827||Two age groups study: 7-13 Years old and 2-6 Years old
719279|NCT02660801|the participants were recruited among the local community|
719280|NCT02660580||Participants were randomized to either MSB11022 or EU-Humira in Core Treatment Period till Week 16. Participants who achieved PASI50 at Week 16 entered Extension Period where participants in MSB11022 were continued to receive MSB11022 & participants in EU-Humira were re-randomized to receive either MSB11022 or EU-Humira for additional 37 weeks.
719281|NCT02660528||No participants were assigned to treatment arms because none of the participants were eligible to continue the study after screening.
719282|NCT02660242||
719283|NCT02660229||
719284|NCT02660112||
719285|NCT02659787||
719286|NCT02659709|Glaucoma patients and Caregivers were recruited from the Glaucoma Service at Wills Eye Hospital, Philadelphia, PA, USA.|
719287|NCT02659631||Twenty-eight (28) participants were enrolled and 27 participants received study drug. One participant discontinued before receiving treatment.
719288|NCT02659540||
719289|NCT02659501||
719290|NCT02659098||
719291|NCT02658877||
719292|NCT02658851||
719293|NCT02658487|The recruitment period for this trial was March 2016 to April 2019. Participants were recruited at Vanderbilt University Medical Center, Yale University, and University Medical School, South Carolina.|42 participants met all eligibility criteria and were enrolled on this study. Nine of the participants received a second induction.
719294|NCT02658461|Eligible participants from the MO22982 (NCT01401166) trial were observed for this time and motion study of trastuzumab. The focus of the observation in this study was the HCP rather than the person being treated, so number of observations is reported everywhere instead of number of participants. Number of participants was not collected.|"Each arm included 12 observations of an episode of care independent of the person being treated. By design of the study, some individuals may have been observed more than once and there may have been fewer than 12 actual participants in each arm. As only a single observation was required to participate, there was no disposition recorded."
719295|NCT02658357||The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study
719296|NCT02658240||
719297|NCT02658149||
719298|NCT02658084||
719299|NCT02658019||
719300|NCT02657928||
719301|NCT02657915||The number of participants eligible for this study was determined by the number of participants who participated in RENEW Study (NCT01721161). A total of 82 participants were enrolled in RENEW Study (NCT01721161) and received at least 1 dose of study treatment. A total of 52 participants participated in this study.
719302|NCT02657889||
719303|NCT02657629||
719304|NCT02657564||
719305|NCT02657538||
719306|NCT02657434||
719307|NCT02657408|This was a randomised, placebo-controlled, double-blind, parallel-group study in a single trial center. In this study 57 healthy smoking subjects were entered and randomized. Subjects were allowed to rescreened twice based on investigator´s judgment with new informed consent & unique study subject number.|All subjects (Subjs) were screened for eligibility to participate in trial. Subjs attended specialist site to ensure that they (the Subjs) met all implemented inclusion/exclusion criteria. Subjs were not to be randomised to trial drug if any of specific entry criteria was violated.
719308|NCT02657369|Participants took part in the study at 13 investigative sites in France, Italy, United Kingdom, Australia and the United States from 07 July 2016 to 26 September 2018.|A total of 48 participants were screened, of which 14 were screen failures and 34 were enrolled to receive study treatment.
719309|NCT02657252||Some patients (n=17) were withdrawn because did not appear at the previous scheduled appointments, and were replaced for new ones. In order to avoid loss of individuals we have decided to include 17 more patients.
719310|NCT02657226|This is an observational study. Hence, no prospective enrollment was performed. Collected data was analysed on patients meeting inclusion criteria for the study periof from year 2000 to 2008.|
719311|NCT02657031||
719312|NCT02656875||
719313|NCT02656836|Could not recruit target number of participants within the time frame|
719349|NCT02653495|Advertising and Research Volunteer Repository Database|Pre-screening took place along with a two-step screening visit for eligibility criteria. Those not meeting eligibility would screen out: 86 prescreened, 28 initial contact for screening.
719350|NCT02653456||
719314|NCT02656745|"We recruited potential participants from May to July 2016. Digital advertisements were posted to social media outlets targeting users who searched for quit smoking. The study team contacted respondents by telephone to prescreen for eligibility and, if appropriate, directed them to a Web portal for the study."|All participants that completed informed consent, baseline survey, and downloaded the app were included in the single arm ITT sample.
719315|NCT02656693||
719316|NCT02656485||
719317|NCT02656420||
719318|NCT02656329|The Study was conducted at 70 centers in United States of America, Canada and Europe between 30 December 2015 and 04 May 2018. A total of 395 participants were enrolled in study, of which 52 were screen failures mainly due to exclusion criteria met.|Out of 343 participants, 321 participants with 25% <=left ventricular ejection fraction (LVEF) <=35% were randomized in a 1:1 ratio to the AdreView™ group or Standard of Care (SoC) group stratified by enrolling center via an interactive web response system and 22 participants were not randomized but included in safety analysis set.
719319|NCT02656290||
719320|NCT02656199|0 participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.|0 participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.
719321|NCT02656173|Male participants with overactive bladder (OAB) under treatment with the α-blocker tamsulosin for benign prostatic hyperplasia (BPH) were enrolled in Japan (53 sites) and Korea (5 sites).|Eligible participants received tamsulosin 0.2 mg and placebo orally once a day after breakfast for 4 weeks. Subsequently, participants who met the eligibility criteria at the end of this 4 week screening period were randomized 1:1 to mirabegron 50 mg group or placebo group with tamsulosin 0.2 mg orally once a day after breakfast for 12 weeks.
719322|NCT02656160||
719323|NCT02656069|The recruitment period began 15 March 2017 and ran through 30 June 2017. Subjects were screened for study eligibility at one of the 7 clinical sites up to 60 days prior to randomization.|A total of 6 screened and eligible subjects were not randomized to one of the treatment sequences due to closing of the enrollment period.
719324|NCT02655887|The study was activated at 25 investigational sites in the U.S., Europe and Australia. First subject was enrolled June 15, 2016, and the last subject on May 1, 2017. Approximately 60% of subjects are in the U.S.|Three U.S. sites were activated, but did not consent subjects. A fourth site enrolled 1 subject who was lost to follow-up after discharge (site closed). Fifty-eight (58) screen failures reported and three (3) eligible subjects were not treated with the device. In total, 170 subjects were treated with VENOVO.
719325|NCT02655679||
719326|NCT02655666||
719327|NCT02655653||
719328|NCT02655510||
719329|NCT02655419||The study was conducted at 11 centers in 3 countries from 19-May-2016 to 26-Oct-2017.
719330|NCT02655237|Participants took part in the study at 34 investigative sites in Japan from 05 March 2016 to 25 September 2017.|Participants with a diagnosis of uterine fibroids were enrolled in 1 of 2 (Relugolix once daily and Leuprorelin once in 4 weeks) treatment groups.
719331|NCT02655224|Participants took part in the study at 15 investigative sites in Japan from 26 March 2016 to 19 May 2017.|Participants with a diagnosis of uterine fibroids were enrolled in a 1:1 ratio in one of two treatment groups: relugolix 40 mg or placebo.
719332|NCT02655016|In this double-blind, randomized, placebo-controlled study, participants with stage III or IV ovarian cancer were randomized to receive either niraparib or placebo in 2:1 ratio. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion.|A total of 989 participants were screened, of which 256 participants did not meet eligibility criteria. A total of 733 participants were enrolled and randomized in the study, of which 728 participants received study treatment (4 participants were screen failures after randomization and 1 participant withdrew consent before first dose).
719333|NCT02654977||
719334|NCT02654782|Subjects were recruited at Mayo Clinic in Rochester, Minnesota.|
719335|NCT02654769||
719336|NCT02654717||
719337|NCT02654652|This study enrolled patients hospitalized with head and neck cancer from Instituto Alfa de Gastroenterologia, Hospital das Clínicas de Minas Gerais, from October 2014 until April 2016|Of the 40 patients screened, six were ineligible: esophageal cancer (1), cirrhosis (1) and four were inoperable. Forty were randomized (19 - symbiotic group and 21 - control)
719338|NCT02654639||
719339|NCT02654483||"A 30-day washout period from prohibited medications (if applicable) is included prior to arm assignment.
~All patients who complete the double-blinded period will be offered a 2-month period on active drug."
719340|NCT02654314||
719341|NCT02654145|Participants with severe eosinophilic asthma who were receiving omalizumab, but were not optimally controlled were enrolled in this open-label study and received mepolizumab 100 milligrams (mg) subcutaneously (SC) every 4 weeks for 32 weeks with last dose on Week 28. The study was conducted at 46 centers from 17 March 2016 to 31 May 2017.|Screening was performed at Visit 1 (Week -1). A total of 206 participants were screened of which 54 participants were screen failures. Seven additional participants were reported as pre-screen failures. The remaining 145 participants received at least one dose of mepolizumab.
719342|NCT02654132||157 participants were enrolled, 117 were randomized at 39 sites in 10 countries. Of the 117, 60 participants were randomized into the E-Pd group and 57 were randomized into the Pd group.
719343|NCT02654054||Eligible participants were randomized in a 1:1:2 ratio to 1 of 3 treatment groups: placebo, elagolix 300 mg BID, or elagolix 300 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) once daily (QD).
719344|NCT02654002|Participants were enrolled at one study site in the United States. The first participant was screened on 20 January 2016. The last study visit occurred on 14 July 2016.|183 participants were screened. No participants were enrolled in Cohorts 9 and 10.
719345|NCT02653872|This study was conducted at PAREXEL Early Phase Clinical Unit - London|Fifteen healthy male subjects were enrolled in the study to assess the pharmacokinetics (PK) of AZD7986 when administered alone (Treatment Period 1) and in combination with multiple doses of verapamil (Treatment Period 2) and itraconazole (Treatment Period 3).
719346|NCT02653768||
719347|NCT02653625||
719348|NCT02653560||
719351|NCT02653417||
719352|NCT02653326||
719353|NCT02653183|118 subjects were enrolled and 113 subjects were randomized, Out of the 113 randomized subjects. Screening failure, IP never applied, inclusion criteria inclusion criteria 4 not met.=5 Not included in the analysis The patient signed IC after data been entered into the eCRF. Excluded from the analysis=5|
719354|NCT02653170|Patients and their caregivers were recruited from three mid-Michigan hospital stroke units. MISTT recruitment started in January 2016 and concluded in July 2017.|"Of 320 enrolled patients, 55 were excluded prior to randomization due to extended rehab stays lasting >4 weeks (n=36), health reasons preventing participation (n=7), and other reasons that contributed to ineligibility (n=12).
~Of 210 enrolled caregivers, 41 were excluded prior to randomization due to exclusion of their patient."
719355|NCT02653144||
719356|NCT02652949|100 subjects (53 US, 47 Outside US [OUS]), from 18 US sites and 15 OUS sites, contributed to the global cohort. The 1st subject was enrolled on 25/APRIL/2016, the 100th subject on 28/MARCH/2018.|A total of 152 subjects were consented to be reviewed for enrollment. 52 subjects were not approved for implantation, 100 subjects were approved for implantation. The 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up.
719357|NCT02652780||
719358|NCT02652767||
719359|NCT02652624|Participants were enrolled at study sites in the United States, Russian Federation, Thailand, Dominican Republic, and Uganda. The first participant was screened on 19 February 2016. The last study visit occurred on 26 November 2018.|491 participants were screened.
719360|NCT02652481||
719361|NCT02652468||
719362|NCT02652416|This was a randomised, double-blind, placebo-controlled, single-centre trial investigating single rising dose (SRD) groups (25 milligram (mg), 50 mg and 100 mg) and a multiple dose (MD) (100 mg) in healthy Chinese and Japanese male subjects. This trial had an SRD plus MD nested design. All subjects from SRD 100 mg also participated in the MD part.|Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue therapies was allowed for all subjects as required.
719363|NCT02652390|This is a long-term follow-up of patients who participated in a randomized trial. In the initial trial the patients were recruited between November 7, 1998 and March 10, 2011 (NCT00806871; see Atroshi et al. Ann Intern Med 2013). Data in this follow-up were collected between February 24, 2016 and July 7, 2016.|No significant events occurred after participant enrollment but prior to assignment to arms.
719364|NCT02652260||
719365|NCT02652221||
719366|NCT02652208||
719367|NCT02652156||
719368|NCT02651987|Subjects with well differentiated, metastatic or locally advanced, unresectable, pancreatic or midgut neuroendocrine tumours (NETs) and who had radiologically documented disease progression as per Response Evaluation Criteria in Solid Tumours (RECIST) v1.0 whilst receiving treatment with lanreotide Autogel® 120mg, every 28 days for at least 24 weeks were enrolled into this study in 25 centres across 10 countries.|Subjects who had centrally reviewed, radiologically documented disease progression within 24 months prior to enrolment and whilst receiving treatment with lanreotide Autogel® 120 mg, administered every 28 days for at least 24 weeks, were recruited into one of two cohorts based on the primary location of NET (i.e. pancreatic NET [panNET] or midgut NET cohort).
719369|NCT02651922||
719370|NCT02651688||
719371|NCT02651584||
719372|NCT02651467|Participants were recruited from one center in USA.|Total 265 participants were screened, out of which 221 participants were randomized. 44 participants were not randomized; 43 participants did not meet the study criteria and 1 participant withdraw his consent before getting randomized to any study treatment.
719373|NCT02651415|Study conducted from August 2016 - November 2018. 12 Patients were enrolled but only 10 were evaluable.|
719374|NCT02651337|5 participants consented for study participation, 4 patients were enrolled|
719375|NCT02651272||
719376|NCT02651259|The first participant was enrolled on March 13, 2017 and accrual was completed on June 12, 2018 across the following sites: Siriraj Hospital, Mahidol University NIC (CRS 5115), Kenya Medical Research Institute/Walter Reed Project (CRS 5121), Malawi (CRS 12001), the Les Centres GHESKIO INLR (CRS 30022), and Harare Family Care (CRS 31890).|
719377|NCT02651220||1001 patients were randomized, 24 did not receive any study medication.
719378|NCT02651194||This study included a 35-day screening period.
719379|NCT02651155|Participants took part in the study at 20 investigative sites in Russia from 17 February 2016 to 26 January 2017.|Participants with a diagnosis of chronic idiopathic constipation as determined by the Rome III Diagnostic Criteria for Functional Constipation were enrolled in 1:1 ratio to receive lubiprostone or placebo.
719380|NCT02651103||
719381|NCT02650999||
719382|NCT02650921||
719383|NCT02650895|Study Period: 34 weeks. Initiation Date: 02 June 2014. Completion Date: 15 January 2015. Study site: Clinical Pharmacology Unit, Medpace Inc. Cincinnati, Ohio.|"Diagnosis and Main Criteria for Inclusion:
~The population for this study was healthy males and females between the ages of 18 and 55 years, inclusive, in good health based on medical history, physical examination, electrocardiogram (ECG), and routine laboratory tests, with a body mass index between 18 kg/m2 and 30 kg/m2, inclusive."
719384|NCT02650856||
719385|NCT02650466||
719386|NCT02650440||
719387|NCT02650219|from January 2010 to April 2011, 40 GD1 patients and 20 healthy volunteers (control group) were included in the study in the 12 inclusions centers (medical clinic or hopsital)|
719388|NCT02650193||
719389|NCT02650128|Study recruitment and enrollment took place at seven clinical sites in Australia and Europe between December 2015 and September 2016. A total of 60 subjects with calcified, stenotic de novo coronary arteries were enrolled and treated with the investigational device.|
719390|NCT02649946|Between June 9, 2016, and July 20, 2017, Investigators randomized 280 subjects into the study at 24 sites in the US, Europe, and Australia/New Zealand (50-75% of subjects treated in the US). The final subject completed 6 month follow-up on January 30, 2018. Anticipated data of study completion (last subject, last visit) is Q3, 2019.|
719391|NCT02649894||
719392|NCT02649842||Per SAP there is only one arm. It includes all subjects with ZCT450/525/600 toric IOL in the primary eye.Fellow eye can have the same IOL or a ZCT300/400.
719395|NCT02649556|Of the 984 subjects (488 in the THS arm and 496 in the CC arm) who were enrolled and randomized into the original study, NCT02396381, 672 subjects were enrolled into the extension study (309 in the THS arm and 363 in the CC arm).|"672 subjects enrolled in the extension study; the 857 subjects in the Full Analysis Set - As Exposed (FAS-EX) included subjects for combined analyses from the original six month study who did not enter the extension study. The analysis was performed according to subjects' exposure over the 12 month period as detailed in Arm/Group (Reporting Groups) table."
719396|NCT02649322||
719397|NCT02649218|Of the subjects who completed core study (NCT02477332) that were eligible for extension study, 237 were screened; 226 were enrolled to open-label treatment epoch; 201 (88.9%) completed treatment epoch; 209 (92.5%) entered the post-treatment follow-up epoch and 152 (67.3%) completed the post-treatment follow-up epoch|
719398|NCT02649192||
719399|NCT02648971||
719400|NCT02648698||A total of 120 subjects were assessed for eligibility. All of the 120 subjects were enrolled and randomized into the antibiotic group and the control group on a 1:1 ratio.
719401|NCT02648646||
719402|NCT02648438|This study was conducted at PAREXEL International, Early Phase Clinical Unit, Baltimore, United States of America. A total of 30 subjects were enrolled in the study and Twenty-four subjects completed the study.|The IV infusion was fixed as the first treatment (Period 1), the monodose inhaler was fixed as the second treatment (Period 2) and the oral formulation was fixed as the fourth treatment (Period 4). During Period 3, subjects were split into 2 equal cohorts, multiple-dose DPI and pMDI.
719403|NCT02648230|Enrolled between December 2015 to December 2016.|
719404|NCT02648217|The trial was conducted at 27 sites in 5 countries as follows: Algeria: 4 sites; India: 7 sites; Lebanon: 4 sites; Malaysia: 3 sites; South Africa: 9 sites.|
719405|NCT02648204|A total of 210 sites were approved for recruiting subjects, of which 196 sites randomized the subjects: Bulgaria: 6; Croatia: 6; Finland: 6; Germany: 6; Greece: 8; Hong Kong: 1; India: 22; Ireland: 5; Latvia: 3; Lithuania: 5; Portugal: 4; Romania: 7; Slovakia: 6; Spain: 8; United Kingdom: 8; United States: 95.|
719406|NCT02648178||
719407|NCT02648022||83 patients were consented but only 79 were randomized. 4 participants were withdrawn.
719408|NCT02647944|Participants were enrolled between December 18, 2015 and September 1, 2016 at the Mayo Clinic in Rochester, Minnesota.|
719409|NCT02647905||
719410|NCT02647866|Investigative sites in the US, Poland, Czech Republic, Russia, Romania, Serbia, and Hungary screened patients from January 2016 until June 2017, with the first patient enrolled in June 2016.|A total of 109 patients were screened during the recruiting period. Subjects were enrolled into the study only if all inclusion criteria and none of the exclusion criteria were fulfilled.
719411|NCT02647788|All patients were recruited between 11/18/15 and 1/10/18 and were identified on the physicians surgery schedule as patients receiving either trigger finger or carpel tunnel surgery.|There were 4 patients that were enrolled but did not make it to the randomization stage. 2 patients had liver disease and therefore met exclusion criteria for the study. The other 2 patients did not have surgery.
719412|NCT02647658||
719413|NCT02647645||
719414|NCT02647346||
719415|NCT02647320|A total of 654 subjects were recruited at multiple sites in the United States and Canada.|A total of 654 subjects were screened and 297 subjects passed the run-in screening period and were randomized. One subject failed screening but was randomized in error.
719416|NCT02647281|This was a Phase 1, randomized, double-blind (sponsor un-blinded), placebo-controlled, dose escalation study to determine the safety, tolerability, and pharmacokinetic (PK) profile of GSK3389404 as single and multiple subcutaneous (SC) injections in healthy participants. This study was conducted at 2 centers in London, United Kingdom.|The study was conducted in 2 Parts: Single-Ascending Dose (Part 1) and Multiple-Ascending Dose (Part 2). In Part 1, total of 32 participants were enrolled and all of them were randomized to receive the study treatment. In Part 2, a total of 24 participants were enrolled and all of them were randomized to receive the study treatment.
719417|NCT02646891||
719418|NCT02646826||
719419|NCT02646761||A total of 47 subjects were assessed for eligibility for the study. Nine were deemed ineligible and 38 were randomized into one of the 2 study arms. Subjects were recruited and randomized prior to surgery & the baseline assessment was done approximately 2 to 4 weeks after surgery.
719420|NCT02646566|Estimated recruitment was 700, to deliver 690 evaluable, randomised patients, providing an average of 230 evaluable patients in each of the three groups. The number of randomised patients planned per country was as follows: Germany, 190; France, 15; Canada, 100; and USA, 395|Three patients were randomised but not dosed: 2 due to withdrawal of consent, 1 for other reasons.
719421|NCT02646449||While 11 signed Consent, 7 were started on protocol medications. One patient was excluded after signing consent due to an exclusionary diagnosis (schizophrenia), one due to being over the maximum age limit (patient falsified age at screen), one due to an exclusionary medical diagnosis and one was excluded due to alcohol use under the minimum.
719422|NCT02646332||
719423|NCT02646124||
719424|NCT02645760||
719425|NCT02645617||
719426|NCT02645409||
719427|NCT02645253|This study was conducted at PAREXEL Early Phase Clinical Unit - Los Angeles|Twenty-seven participants were randomized in 3 sequential cohorts. Each cohort consisted of nine participants in it. Within each cohort, 7 participants were randomly assigned to receive AZD7594 (different doses) and 2 subjects were randomly assigned to receive placebo.
719428|NCT02645123||
719429|NCT02645019||
719430|NCT02644668|Patients with SMA were enrolled at 18 sites in Canada and the United States. The first patient was enrolled on 14 January 2016 and the last patient completed on 31 May 2018.|Eligible patients were male or female, ≥12 y of age and had a genetically confirmed diagnosis of SMA. Ambulatory patients were able to walk ≥50 m in 6 min; and non-ambulatory patients were able to tolerate upright sitting with support for 3 h. Patients had an FVC >20% predicted, an HFMS-E score ≥10 and ≤54, and elbow and knee flexion ≤90 degrees.
719431|NCT02644356||
719432|NCT02644343||
719512|NCT02638051|From January 3, 2014 to December 20, 2014, 260 patients were recruited in Clifford Hospital. They were randomly allocated in two groups with 130 patients in each group.|There was no any pre-assignment dropout or exclusion.
719433|NCT02644278||First Participant First Visit: 29 Feb 2016-Last Participant Last Visit: 19-Oct-2017; A total of 15 participants were enrolled in Part A and no participants were enrolled for Part B as the study was discontinued during dose escalation in Part A, based on business related reasons as decided by the Sponsor.
719434|NCT02644122||
719435|NCT02644109||
719436|NCT02644096|The study was carried out in two orthopaedic departments in Aarhus university hospital in Denmark in the period from January 2005 until May 2007. All patients were recruited from the hospitals waiting list.|180 patients were given the SF-36 questionnaire preoperatively. 175 questionnaires were returned and so 175 patients were randomised into the study.
719437|NCT02643979||
719438|NCT02643875||All subjects who passed the inclusion and exclusion criteria at the baseline visit would be assigned to the treatment for each eye according to the randomization log.
719439|NCT02643862||
719440|NCT02643849||A total of 109 subjects were screened for inclusion. Two subjects were excluded because they did not meet all inclusion/exclusion criteria and did not participate. Therefore the Intent to Treat population was 107 subjects, each of whom received at least 1 stent insertion.
719441|NCT02643693|Study initiated (1st subject screened): 16 November 2015 A demonstration of the P3L system and the VUSE e-cigarette system was given to the subjects.|"Enrolled population = 24 subjects All enrolled subjects met all of the inclusion and none of the exclusion criteria for the study.
~Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC)."
719442|NCT02643628||55 subjects screened with 45 meeting eligibility criteria and enrolled. One subject discontinued by investigator. 44 subjects randomized 23 to Microneedling + Bellafill and 21 to Microneedling alone.
719443|NCT02643615||
719444|NCT02643472||
719445|NCT02643394||
719446|NCT02643355|Patients were recruited in the ED only, by ED physicians|One patient signed consent but withdrew before randomization to drug (Explaining N=70 total)
719447|NCT02643251||
719448|NCT02643225||
719449|NCT02643199|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.
~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria."|
719450|NCT02643095||
719451|NCT02643082|This study was conducted at 1 site in Antwerp Belgium from January 2016 to December 2016.The study was anticipated to run for approximately 9 months but not to expected to exceed 12 months. The study period was duration was expected to run approximately 13 weeks for each subject.|Subjects were randomized into 1 of 2 treatment sequences: subjects in Sequence 1 received GFF MDI in Treatment Period 1 followed by Placebo MDI in Treatment Period 2, and subjects in Sequence 2 received Placebo MDI in Treatment Period 1 followed by GFF MDI in Treatment Period 2. There was a a washout of 5-21 days,in between treatment periods.
719452|NCT02643004||
719453|NCT02642991||
719454|NCT02642965||
719455|NCT02642952||
719456|NCT02642835||
719457|NCT02642679|Patients scheduled to undergo split-thickness skin graft harvesting in the Divisions of Burn and Plastic Surgery at the Brigham and Women's Hospital during the period of time from January to December 2016 were identified as possible study candidates.|Enrolled participants were excluded from the study prior to experimental dressing application if they were found unable to comply with necessary wound care/follow up, or if their surgeon requested they no longer be enrolled.
719458|NCT02642653||
719459|NCT02642627||
719460|NCT02642614|Double dummy trial, 2 different type of medication were dispensed to the patient with the help of two different bottles: Bottle 1 - 5 mg OR 25 mg BI 1026706 tablets or placebo tablets matching 5 mg and 25 mg BI 1026706 tablets, Bottle 2 -100 mg tablets or Placebo tablets matching 100 mg BI 1026706 tablets.|All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered in to the trial if any of the specific entry criteria was violated.
719461|NCT02642575|"This was a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital from January 2016 to august 2016.
~67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study."|
719462|NCT02642536||
719463|NCT02642432||This study included a 35-day screening period.
719464|NCT02642393||
719465|NCT02642237||
719466|NCT02642159|The study was conducted at 119 centers in 15 countries. A total of 864 participants were screened between March 2016 and September 2016, 451 of whom were screen failures. Screen failures were mainly due to inclusion criteria not met.|Randomization was stratified by investigator's choice of usual care therapy, which was pre-specified prior to randomization. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 2:1 ratio (alirocumab: usual care) after confirmation of selection criteria. 413 participants were randomized.
719467|NCT02641912|Participants were recruited at one center in United States of America.|A total of 104 participants were screened. Out of which 100 participants were randomized and stratified based on confirmed Sjögren's syndrome status (Yes[Y]/No[N]).
719468|NCT02641730||
719469|NCT02641587||"Following enrollment of 121 subjects, each subject received a product test of CHTP 1.2 prior to randomization.
~One subject was not randomized due to the physician's decision. This subject is included in the Exposed Not Randomized reporting group of the Baseline Characteristics.
~Consequently, 120 subjects were randomized."
719470|NCT02641561||
719471|NCT02641522||
719472|NCT02641392|310 adult participants who had previously participated in the main study GED-0301-CD-002 were enrolled at 167 study sites in 29 countries.|"Includes participants with Crohn's disease who had previously participated in the main study GED-0301-CD-002 through Week 12 at minimum and completed participation through the last treatment visit at Week 52, or met the early escape criteria and were discontinued beginning at Week 12 through Week 52."
719513|NCT02638012||
719514|NCT02637999||
727222|NCT01986114||495 represents the total number of subjects who were treated with study drug.
727223|NCT01986101||
719473|NCT02641379|This study was conducted in 2 parts. Part 1 was conducted from 16 May 2003 to 12 September 2008 at 21 centers in Austria; Part 2 of this study was conducted from 19 October 2009 to 15 November 2013 at 15 centers in Austria.|A total of 545 participants were enrolled in Part 1, of which 5 participants were treated but were not included in any analysis population due to a missing post-baseline safety assessment. A total of 176 participants were enrolled in Part 2 of this study.
719474|NCT02641249|Dates of Recruitment: 10/2014-2/2016 Location: Hospital|
719475|NCT02641080||
719476|NCT02641067||
719477|NCT02640807||
719478|NCT02640755|First subject enrolled: 8 February 2016; Last Subject Last Visit: 21 December 2016 (End of Study [EoS]). The study was performed at a single study centre in the United Kingdom. Adult patients with advanced solid tumours refractory or resistant to standard therapies were recruited into this 2 period study.|4 patients were enrolled (signed informed consent). Following [14C]-AZD2014, patients either continued AZD2014 as monotherapy or in combination with a standard regimen of fulvestrant or paclitaxel as appropriate and at the Investigator's discretion. No patients were recruited into AZD2014+paclitaxel treatment regimen.
719479|NCT02640716||
719480|NCT02640677|At the end of recruitment of this pregnancy registry for Bexsero, there were only 2 registrations. Of these,1 subject withdrew the consent and the other subject did not return for a follow up, hence considered as lost to follow up. Therefore, no pregnancy outcome data are available for this study.|
719481|NCT02640625||
719482|NCT02640612|This study was an open-label extension trial. Adult patients with moderate to severely active rheumatoid arthritis (RA) who completed Trial NCT02137226 (1297.2), wished to participate in this extension trial and per Investigator's assessment could benefit from continuing to receive BI 695501 were included in this trial.|All patients were screened for eligibility to participate in the trial. The screening visit of this trial was the Week 48 visit in Trial 1297.2.
719483|NCT02640573||
719484|NCT02640547|In this prospective, multi-center observational study a total of 394 adult patients chronically infected with hepatitis C virus (HCV) were enrolled at 17 centers in Poland.|Effectiveness analyses of clinical outcomes are reported by HCV genotype. Safety variables were analyzed by treatment regimen.
719485|NCT02640482|Safety population: All participants who received at least one dose of study drug.|A total of 304 subjects were randomized and 302 subjects received at least 1 dose of study drug.
719486|NCT02640404|Participants were enrolled from 06 June 2016 through 16 June 2016 at a single center in Vietnam.|A total of 224 participants (112 for each group) were enrolled and vaccinated in the study.
719487|NCT02640235||
719488|NCT02640157||A total of 506 participants were randomized and 505 received ≥ 1 dose of study drug. One participant in Arm B was randomized in error and never dispensed study drug. This participant is included in the total number of participants in Arm B who discontinued the study. This study included a 42-day screening period.
719489|NCT02640053|Forty-six (46) participants were enrolled from 13 academic and community practice institutions in the United States between 12/24/2015 and June 16, 2017.|There were three patients who withdrew consent (1 cryotherapy, 2 control) and one patient on the cryotherapy arm who was found to be ineligible. All of these 4 participants were excluded from all analyses.
719490|NCT02639910||
719491|NCT02639637||
719492|NCT02639559||
719493|NCT02639494||
719494|NCT02639429||
719495|NCT02639390||
719496|NCT02639351|80 subjects were recruited from 1 site in Germany.|
719497|NCT02639338|Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 December 2015. The last study visit occurred on 02 January 2017.|315 participants were screened.
719498|NCT02639286||
719499|NCT02639247|Participants were enrolled across 101 study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 December 2015. The last study visit occurred on 18 January 2017.|397 participants were screened.
719500|NCT02639182|Participants who were atleast 18 years of age with all histologies of confirmed renal cell carcinoma and evidence of progression on or after the last regimen received were enrolled.|Randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1), the number of prior systemic RCC regimens (2 or > 2) and Renal cell carcinoma (RCC), histology (clear or nonclear cell).
719501|NCT02639052||
719502|NCT02638974||
719503|NCT02638948||Out of 508 participants who signed the informed consent form and were enrolled in the study; 248 participants were randomized, and 247 participants were administered study drug (1 participant did not take any double-blind study medication).
719504|NCT02638623||
719505|NCT02638597||
719506|NCT02638493|All participants were recruited at the University of North Carolina at Chapel Hill and surrounding areas, through Institutional Review Board (IRB)-approved advertisements.|Participants interested in the study were pre-screened for eligibility using an IRB-approved questionnaire.
719507|NCT02638337|Participants were randomized at 68 sites in the United States.|After a screening period of up to 4 weeks, participants who met all eligibility criteria were randomized in a 1:1 ratio to receive either ospemifene 60 mg once daily or matching placebo for 12 weeks. Randomization was stratified by severity of most bothersome symptom of vaginal dryness on Day 1 and by the presence or absence of the uterus.
719508|NCT02638259||
719509|NCT02638168||
719510|NCT02638129||Sixty-seven (67) participants randomized into the double-blind lead-in period (Enrolled Set), while 58 participants were randomized into the double-blind treatment period (Full Analysis Set).
719511|NCT02638103|Participants with chronic or episodic migraine (CM or EM) who completed the pivotal efficacy studies of fremanezumab (TV48125-CNS-30049 [NCT02621931] and TV48125-CNS-30050 [NCT02629861]) and agreed to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), were enrolled in this study.|A total of 1890 participants were enrolled, including 917 participants with CM rolled over from Study TV48125-CNS-30049, 661 participants with EM rolled over from Study TV48125-CNS-30050, and 312 newly enrolled participants (193 with CM and 119 with EM).
719554|NCT02633488||6 subjects failed the screening. 2 subjects voluntarily withdrew.
719555|NCT02633371||
719515|NCT02637856|The study was conducted in North America at 90 study sites in the U.S. and Canada.|Participants with relapsing remitting multiple sclerosis (RRMS) were enrolled, who had had a suboptimal response to an adequate course of a disease-modifying treatment (DMT). An adequate course of prior DMT was defined as the same DMT administered for at least 6 months.
719516|NCT02637804||
719517|NCT02637557||
719518|NCT02637323|Patients were screened for study eligibility at four (4) study centers in the United States (US).|Patients were enrolled sequentially with at least 10 patients per Cohort. Subjects were enrolled within 14 days of Screening.
719519|NCT02637141|This study was conducted at three sites in Finland.|Participants who met the study entry criteria were randomized at a 1:1:1 ratio to receive 150 mg or 300 mg AMG 714 or placebo once every 2 weeks for a total of 6 administrations over a period of 10 weeks. Randomization was stratified by study site and sex.
719520|NCT02637063||
719521|NCT02637037|This study was conducted at PAREXEL International, Early Phase Clinical Unit Baltimore, United States of America. Subjects were randomized into 4-period, 4-treatment (per study part) crossover (4 sequences containing 4 treatments) in fed and fasted state.|Sequences 1, 2, 3 and 4 Part 1: ABCD, BADC, ABDC, BACD Part 2: EFGH, FEHG, EFHG, FEGH (A = test, fed; B = reference, fed; C = test, fasted; D = reference, fasted; E = test, fed; F = reference, fed; G = test, fasted; H = reference, fasted) A total of 80 subjects were randomized into the study
719522|NCT02636907|"An Open-label, Interventional clinical trial followed by an extension phase of BI 695501 in patients with Rheumatoid Arthritis.
~EoT: End of treatment (EoT)"|All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered to trial drug if any of the specific entry criteria was violated.
719523|NCT02636712|The recruitment has finished on 25 Dec 2015 and totally 10 patients.|
719524|NCT02636608|This observational study was conducted in 14 medical centers in Hungary experienced in the treatment of chronic hepatitis C (CHC). The first participant entered the study on November 27, 2015 and last patient last visit was on 23 May 2018.|
719525|NCT02636595||This study included a 35-day screening period.
719526|NCT02636361||
719527|NCT02636283||
719528|NCT02636049||
719529|NCT02635984||
719530|NCT02635880||
719531|NCT02635828||54 participants provided written consent for the study, and only 40 participants were randomized.
719532|NCT02635646||
719533|NCT02635542||
719534|NCT02635425||
719535|NCT02635347||The number of participants, 94, reflects the enrolled subjects, 31 + historical controls, 63.
719536|NCT02635204||
719537|NCT02634983|The study took place in 3 clinical sites in United-Kingdom|31 patients were randomized, all of whom were included in the safety set and PD analysis sets (primary population of interest)
719538|NCT02634827|One (1) patient was accrued from December 2015 to June 2018 at Mayo Clinic. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|
719539|NCT02634814||
719540|NCT02634801|Treatment Period (Weeks 0 to 24), Extension Period (Weeks 24 to 36) followed by post-treatment follow-up period occurring from last treatment visit (week 36), or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.|
719541|NCT02634788||
719542|NCT02634606|The enrollment period was 3/22/2011 - 11/13/2015 and took place in a private setting the clinic located at the site.|Thirteen subjects with cholesterol level (>180 mg/dl), aged 37-64, taking statins drug at the time were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill) for 12 weeks. Randomization was not performed due to limited subjects recruited.
719543|NCT02634580|"This study was conducted at 30 centers in Japan. Participants were enrolled from 27 February 2016 to 18 May 2017.
~The study consisted of a 12-week double-blind (DB) treatment period and a 9-month open-label extension (OLE) period."|Participants were randomized 1:1:2:2 into 1 of 4 treatment groups for the 12-week, double-blind treatment period. Randomization was stratified by screening low-density lipoprotein cholesterol (LDL-C) level (< 180 mg/dL vs. ≥ 180 mg/dL) and baseline statin use (yes vs. no).
719544|NCT02634346||Disposition is shown for the safety population - subjects who were randomized and received at least 1 dose of study drug. 1 subject in the placebo group and 1 subject in the olanzapine-only group were randomized but not treated, and thus were not included in the safety population.
719545|NCT02634320|Subjects had schizophrenia, and had been taking paliperidone palmitate (PP) or Risperidone long-acting injection (RLAI) with inadequate results for at least 3 doses prior to screening.|All subjects received 4 to 6 doses of aripiprazole lauroxil in monthly or 6-week intervals.
719546|NCT02634177||304 Randomized
719547|NCT02634151||Participants who had heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) and were on a statin therapy were enrolled in this study.
719548|NCT02634073||Sixteen subjects were randomized to one of the 4 treatment sequences separated by >=7 day washout between doses.
719549|NCT02633956||Subjects using statins within 30 days of the initial Screening visit (Screening Visit 1) are required to stop statin therapy immediately following this initial visit and must undergo a 4-week statin washout period prior to Screening Visit 2.
719550|NCT02633800||Of 125 screened, 87 patients from 8 countries were randomized into treatment groups
719551|NCT02633787|Study participants were enrolled from 15 December 2015 to 28 December 2015 at 4 clinic sites in the United States.|A total of 110 participants who met all inclusion and none of the exclusion criteria were enrolled; 109 participants completed the trial.
719552|NCT02633735||ED Sites were randomized to the AppyCDS intervention or usual care (UC). Sites were stratified by health system and then grouped on patterns of pediatric referral and provider cross coverage. EDs or groups of EDs were sorted into pairs by estimated pediatric patient volume. Study phases were consistent but date ranges varied by health system.
719553|NCT02633501||Among the 312 screened subjects, 32 subjects were screening failure. 280 subjects were randomized: 28 in subset 1 and 252 in subset 2. Images from the subset 1 were used for training of off-site readers and validation of imaging protocol. Consequently, these subjects were not included in the efficacy analysis but only in the safety assessment.
727224|NCT01986062||
719557|NCT02633241|Patients were recruited from 3.2.2017 and the final patient was enrolled 1.11.2018. Recruitment occurred after mail and phone contact approximately 2 weeks before the study and consent was obtained on the day of the study.|
719558|NCT02633215||
719559|NCT02633020|This study was conducted at 6 sites in France, Netherlands, Finland, Spain, and the United States. Participants with previously confirmed diagnosis of refractory coeliac disease (RCD) type 2 were enrolled from April 13, 2016 to January 19, 2017.|Participants were randomized in a 2:1 ratio to receive either 8 mg/kg AMG 714 or placebo. Randomization and initial dosing of the first 10 participants were staggered to allow observation for any possible unanticipated side effects.
719560|NCT02632838|Participants were recruited though recruitment flyers, nurses and community health workers (CHWs). Potential participants were invited to attend the information session held by the research team. Informed consent and Health Insurance Portability and Accountability Authorization were obtained for those who were eligible to participate in the study.|We have total 30 participants enrolled in the study, there was no significant events occurred before they were assigned to groups.
719561|NCT02632812||
719562|NCT02632786||
719563|NCT02632747|A randomized, double-blinded, placebo-controlled, crossover trial to compare the effect of empagliflozin versus placebo when added to ramipril on reducing glomerular hyperfiltration in patients with type 1 Diabetes mellitus (T1D), Type 2 Diabetes (T2D), or obesity.|Participants who successfully completed the 4 weeks open-label ramipril run-in period and meet all of the inclusion, and non of the exclusion criteria were randomized into the trial, with no stratification to one of two sequences.
719564|NCT02632526|This study was conducted on 96 healthy male participants at a single center: PAREXEL Early Phase Clinical Unit - London. This study consisted of 2 parts: Part A - single ascending dose (SAD) and Part B - multiple ascending dose (MAD).|Screening period was from Day -28 and Day -1. Participants signed informed consent form; demographic data, medical history and concomitant medication details were collected; weight, height and body mass index were measured; inclusion/exclusion criteria were checked, serology and screening of urinary drugs of abuse, alcohol and cotinine were done
719565|NCT02632110||
719566|NCT02631954||Subjects who passed the screening were randomized using IWRS before conducting the clinical trail.
719567|NCT02631876||A total of 366 participants were randomized in 2:1 to receive either mirvetuximab soravtansine or the investigator's choice (IC) chemotherapy.
719568|NCT02631837|Between December 9, 2015, and February 23, 2017, 194 women were screened for eligibility|
719569|NCT02631772||
719570|NCT02631746||
719571|NCT02631590||
719572|NCT02631577||All participants received daily low-dose aspirin (81-100 mg) during lenalidomide treatment and until 28 days after the last dose of lenalidomide. Participants who are unable to tolerate aspirin, who have a history of thromboembolism (TE), and who are at high risk of TE, received warfarin or low-molecular-weight heparin (LMWH).
719573|NCT02631551||
719574|NCT02631525||
719575|NCT02631070|This is an ongoing double-blind randomized, Phase 3 trial. Participants were randomized in a 2:1 ratio to luspatercept or placebo treatment and data are reported up to the data cut off date of 01 July 2019. Participants were enrolled at 65 sites in 11 countries.|Participants were randomized based on red blood cell (RBC) transfusion burden at baseline (≥ 6 RBC units/8 weeks versus < 6 RBC units/8 weeks [based on the mean of the 2 consecutive 8-week periods immediately prior to randomization]) and the International Prognostic Scoring System (IPSS) for myelodysplastic syndromes (MDS) at baseline.
719576|NCT02631057||
719577|NCT02630992||
719578|NCT02630966|Participants took part in the study at 13 investigative sites in Canada, France, Italy, the Netherlands, Spain, the United Kingdom, and the United States from 10 August 2016 to 14 November 2018.|Participants with diagnosis of moderately to severely active Crohn's disease and 1 to 3 draining perianal fistula(e) of at least 2 weeks duration were randomized in 1:1 ratio to receive vedolizumab IV 300 mg dose at Weeks 0,2,6,14,22 and vedolizumab placebo-matching IV dose at Week 10 or vedolizumab IV 300 mg dose at Weeks 0,2,6,10,14,and 22.
719579|NCT02630719||
719580|NCT02630706|In total, 1078 participants were screened, and 506 participants were randomized at 50 sites in China, Hong Kong, Republic of Korea, the Philippines, and Taiwan.|
719581|NCT02630693||
719582|NCT02630563|The study was conducted between 02 May 2003 and 20 January 2005. This study was conducted at 2 sites in United States (US). Overall, 9 participants entered the study.|Thirty five participants were screened; 9 entered the study following a screening period of up to 14 days. Stable pediatric liver transplant participants who were at least 6 months post-transplant and who were receiving stable dose of Mycophenolate Mofetil (MMF) in combination with cyclosporine were enrolled into the study.
719583|NCT02630472||
719584|NCT02630459|"The study, initiated on 06 January 2016 at 43 centers in Japan, included a 24-week double-blind treatment phase (DBTP) followed by a 76-week open-label (OL) treatment phase (OLTP).
~DBTP: participants were randomized 2:1:2:2 to receive placebo, erenumab 28 mg, erenumab 70 mg, or erenumab 140 mg once monthly (QM) subcutaneously (SC)."|"OLTP: participants received erenumab 70 mg and/or 140 mg QM SC (depending on the participant's visit completion status after a protocol amendment).
~Optional 85-day clinical home use (CHU) sub-study during the OLTP: participants randomized 1:1 to erenumab using two 70 mg/mL or one 140 mg/mL autoinjector (AI)/pen(s)."
719585|NCT02630251|This was a single-agent open-label dose escalation study to determine the Maximum tolerated dose (MTD)|The study was terminated due to development of another bromodomain and extra-terminal(BET) Inhibitor with a better understanding of the risk benefit profile.
719586|NCT02630186|Three patients were enrolled at a single center in the United States.|The Dose Finding Phase included a 7 day Run in Period of rociletinib monotherapy, at the Dosing Cohort-defined dose level, prior to the initiation of combination treatment.
719587|NCT02629965|This was a randomised, double-blind, active-controlled, 2-way crossover trial to assess the effects of once daily treatment of orally inhaled Tiotropium + Olodaterol FDC 5 μg/5 μg or Tiotropium 5 μg over 12 weeks of treatment in Japanese patients with Chronic obstructive pulmonary disease (COPD).|All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
719588|NCT02629861||A total of 2995 patients with migraine provided written informed consent. Of the 2995 patients screened, 875 met entry criteria, including diagnostic criteria for episodic migraine (EM) and diary compliance during the run-in period, and were randomized into this study from 123 study centers by 123 investigators.
719589|NCT02629822||
719590|NCT02629354||All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist site ensured that they (the subjects) met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
719591|NCT02629159|"Participants with moderately to severely active rheumatoid arthritis (RA) on a stable dose of methotrexate with an inadequate response were randomized at 286 study sites in 41 countries.
~This study is currently ongoing; results are reported as of the data cut-off date of 02 February 2018, when all participants were to have completed Week 26."|"Participants were randomized in a 2:1:2 ratio to receive placebo, adalimumab, or upadacitinib. Randomization was stratified by prior exposure to biologic disease-modifying anti-rheumatic drug(s) (bDMARD) (yes/no) and geographic region.
~Rescue therapy was offered to participants who met protocol-specified criteria at Weeks 14, 18, 22, or 26."
719592|NCT02629133||
719593|NCT02629094||
719594|NCT02628964||
719595|NCT02628938|Recruitment took place between March and December 2014 in the dental clinics of Riyadh colleges of Dentistry and Pharmacy|212 female students aged 18-35 were screened. 167 were excluded for not meeting the inclusion criteria. Only 45 were finally enrolled and distributed on the three groups
719596|NCT02628873|Participants were recruited from existing practice and clinic patients who had the Essure device placed for contraception.|
719597|NCT02628769||
719598|NCT02628743||
719599|NCT02628600||Participants in Study INS-212 had either received 590 mg LAI plus an MDR (LAI + MDR arm) or a multidrug regimen alone (MDR alone arm). All participants in this safety extension study, INS-312, were to continue the multidrug antimycobacterial regimen that they were receiving during Study INS-212 and received LAI 590 mg QD for up to 12 months.
719600|NCT02628418||
719601|NCT02628236||
719602|NCT02628223||
719603|NCT02628106|Our overall recruiting cycle for 40 days, mainly for patients with chronic kidney disease patients, which is divided into diabetic nephropathy and non-diabetic patients|Chronic kidney disease patients were divided into diabetic nephropathy and non-diabetic group, ordinary chronic kidney disease patients with diabetes mellitus were excluded
719604|NCT02628093||73 subjects were enrolled, and 60 of them were randomized into the two groups.
719605|NCT02628028||The study consist of 2-parts. Part A included participants with at least mildly active rheumatoid arthritis (RA) and Part B included participants with moderately to severely active RA. Long-term extension (LTE) period allowed eligible participants who completed Part B of study to receive LY3337641 up to an additional 52 weeks.
719606|NCT02627963||
719607|NCT02627924|Ninety-one patients diagnosed with rheumatoid arthritis (RA) were enrolled at nine different sites in Korea.|
719608|NCT02627794||
719609|NCT02627144||
719610|NCT02627118||
719611|NCT02627001||
719612|NCT02626910||
719613|NCT02626819||
719614|NCT02626780||
719615|NCT02626611||All enrolled participants received Xolair but only those not withdrawn progressed to the Active Study Phase of allergen exposure.
719616|NCT02626520||
719617|NCT02626182||
719618|NCT02626026|Participants were enrolled at 11 study sites in the United States. The first participant was screened on 26 January 2016. The last study visit occurred on 01 September 2016.|58 participants were screened and 42 participants were enrolled.
719619|NCT02626000|This study was conducted at 19 centers in Australia, Canada, Europe, and the United States.|This study is currently ongoing. Results of the primary analysis of the phase 1b part of the study are reported here, as of the data cutoff date of 02 November 2017.
719620|NCT02625974|The study was conducted from 27 JAN 2016 (First subject first visit) to 25 JUL 2018 (End of Part 1 of study) in 18 centers in Argentina, 3 centers in Bolivia and 4 centers in Colombia.|A total of 371 subjects were screened for randomization. Forty-one (41) subjects were excluded from the study during screening. The 330 subjects who were eligible to participate in the study were randomized in a 2:1 ratio to either a 60-Day or 30-Day regimen with nifurtimox tablets.
719621|NCT02625922|There were total 11 centers from 3 countries. (Germany-6, Switzerland-1, and the United Kingdom-4).|
719622|NCT02625844||Patient disposition information was unavailable. Therefore, all participants are represented in one arm.
719623|NCT02625623|Overall, 459 participants were screened for this study. Of which, 371 participants were randomized into the study.|
719624|NCT02625571||No details to provide. All recruited participants were enrolled.
719625|NCT02625545||
719626|NCT02625428||
719627|NCT02625402|Patient recruitment was conducted from December 2015 to March 2016. Patients were recruited at two hospitals. Consent for the study (or enrollment) was implied by completion of the survey, so the enrollment number is lower than the number that started the study and were assigned to a study arm.|
719628|NCT02625324|100 subjects (53 US, 47 Outside US [OUS]), from 18 US sites and 15 OUS sites, contributed to the global cohort. The 1st subject was enrolled on 25 April 2016 (US) & on 08 June 2016 (OUS), the 100th subject on 28 March 2018.|A total of 152 subjects were consented to be reviewed for enrollment. 52 subjects were not approved for implantation, 100 subjects were approved for implantation. The 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up.
719629|NCT02625298|The study involved twenty-four patients, 11 males (45.8%) and 13 females (54.2%) (mean age 13.30±2.83), who came to the University Clinic, due to spontaneous or provoked pain, discomfort during chewing, numbness, and observed swelling.|Based on patient's subjective symptoms, clinical examination, vitality testing and analysis of periapical radiograph, the acute exacerbation of a necrotic pulp with chronic apical periodontitis was diagnosed. If the teeth were unrestorable or with signs of horizontal or vertical root fractures or root resorption, they were excluded from this study.
727225|NCT01985971||
727226|NCT01985958||
727227|NCT01985932||
727228|NCT01985763||
719630|NCT02625259|Participants took part in the study at 1 investigative site in the United States from 08 January 2016 to 22 July 2016.|Healthy participants were enrolled in this 3-part study to receive TAK-117 in Part 1 as: Crossover of 9*100 milligram (mg) capsules or 3*300 mg tablets, Part 2: Crossover of TAK-117 in fasted or fed state and Part 3: TAK-117 with lansoprazole.
719631|NCT02625233||A total of 105 subjects were enrolled into this study. Of the enrolled subjects all were dispensed a study lens. Out of all the dispensed subjects 103 completed the study while 2 subjects were discontinued.
719632|NCT02625220||A total of 177 subjects were enrolled into this study. Of the enrolled subjects, 7 did not meet the eligibility criteria and 170 subjects were dispensed a study lens. Of the dispensed subjects, 7 were discontinued and 163 completed the study.
719633|NCT02625207||The study was conducted in two parts (Part 1 and 2). Participants were assigned to treatment into 4 cohorts in Part 1 (Cohort 1, 2, 3, 4) and into 2 cohorts in part 2 (Cohort 1, 3).
719634|NCT02625181||
719635|NCT02624986||A total of 45 patients were screened, twenty-five of whom were enrolled in the dose escalation phase. The sponsor decided to terminate the study early and the expansion phase was not opened.
719636|NCT02624843||
719637|NCT02624791||
719638|NCT02624713||
719639|NCT02624700||
719640|NCT02624687||
719641|NCT02624492|This trial was designed to consist of 2 parts. First part was an open-label, non-randomised, Phase Ib dose-escalation trial according to a standard 3+3 design to determine the maximum tolerated dose (MTD) of BI 836286 in combination with gemcitabine and oxaliplatin. Second part of the trial, an open-label randomised Phase II, was not conducted.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that they (the patients) met all inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were violated.
719642|NCT02624375|Recruitment occurred from September 2016 to January 2018. Recruitment was done by placing flyers at retirement homes and by contacting persons over 70 who had previously been enrolled in research studies including giving informed written consent to be re contacted for future studies.|
719643|NCT02624284||
719644|NCT02624050|Recruitment was from 08/2016 through 08/2017 at the pre-anesthesia clinic and on the day of surgery in the pre-operative area.|
719645|NCT02623959|Outpatients with MPE eligible for IPC,no evidence of extensive loculation or hydropneumothorax or other contraindication to pleurodesis or narcotics;aged 18 or older;and has sufficient mental capacity to answer SF-6D and Borg score questions. Out of 3 participants 2 withdrew before randomization.|
719646|NCT02623855||
719647|NCT02623829||
719648|NCT02623803||
719649|NCT02623725|Study participants were enrolled from 14 April 2016 to 19 October 2016 at 5 sites, one each in Brazil, Colombia, Honduras, Mexico, and Puerto Rico.|A total of 251 participants who received 3 doses of CYD dengue vaccine in previous studies CYD13 (NCT00993447) and CYD30 (NCT01187433) were enrolled and randomized in this study (CYD64).
719650|NCT02623361||
719651|NCT02623348|Patients recruited from 3 local San Francisco dialysis clinics|Baseline assessment performed prior to random assignment
719652|NCT02623335|Surgeons at 5 sites were recruited by email and in-person contact. After they were consented, their patients were screened for eligibility and approached in clinic to discuss study participation.|
719653|NCT02623322|The study was conducted at 34 investigational sites in 6 countries including the United States (15 centers), South Africa (12 centers), Canada, Spain, New Zealand (2 centers in each country), and Great Britain (1 center).|Randomization was stratified by onset of influenza-like illness (≤ 36 hours and > 36 hours) and a permuted block randomization method was used to obtain an approximate 1:1:1 ratio of subjects in the 3600 mg MHAA4549A, 8400 mg MHAA4549A, and placebo strata.
719654|NCT02623218||One enrolled participant did not meet eligibility criteria.
719655|NCT02622828||
719656|NCT02622724||
719657|NCT02622568|Pediatric Dermatology Medical Clinic|
719658|NCT02622321||A total of 114 participants were screened, of which 5 were screen failure and 109 were enrolled in this study. Participants in Arm A and Arm B were randomized in a 2:1 ratio; participants in Arm C and Arm D were enrolled without randomization.
719659|NCT02622191|Participants with unilateral primary open-angle glaucoma (POAG) were recruited from the Glaucoma Service at Wills Eye Hospital, Philadelphia, PA, USA. Healthy controls were recruited from staff, friends and family. All participants were recruited between November 2012 and February 2013.|
719660|NCT02622178|Glaucoma patients, suspects and healthy subjects were recruited between 2011 and 2012 in the Glaucoma Service at Wills Eye Hospital, Philadelphia, Pennsylvania, USA.|
719661|NCT02622113||The number of patients continued treatment in this study after TA-7284-11 study was 139. Four patients in the CANA/CANA group who did not continued this study were included in the analysis set. Analysis of this study was conducted 143 patients.
719662|NCT02622074||Sixty participants were allocated and treated on study.
719663|NCT02621983||There is a discrepancy between the enrollment number (50) and the participant flow module (38) because 12 participants either failed the initial screening procedures or were unable to be randomized because they didn't complete the baseline visit prior to randomization.
719664|NCT02621931||A total of 3148 patients with migraine provided written informed consent and were screened for entry into either Study TV48125-CNS-30049 or Study TV48125-CNS-30050. Of the 3148 screened, 1130 met entry criteria, including criteria for chronic migraine and diary compliance during the run-in period, and were randomized into this study.
719665|NCT02621892||
719666|NCT02621619||
719667|NCT02621606|Healthy participants (Part 1), healthy elderly participants (Part 2), and participants with Alzheimer's Disease (AD; Part 3) were enrolled in this study.|N=20 participants were enrolled, with N=20 receiving ≥1 dose of [11C]MK-6884. N=1 participant in Part 2 withdrew from study before receiving the second dose of [11C]MK-6884.
719668|NCT02621424|Two hundred and twenty nine patients were screened. 43 patients were eligible and signed consent. Three withdrew before randomization. Forty were randomized.|Forty patients were randomized. Eight patient withdrew before treatment started. Thirty two patients started the treatment.
719669|NCT02621073||
719670|NCT02621060||
719671|NCT02621047||'Alectinib: Normal Hepatic Function' participants were grouped into 2 arms: 'Alectinib: Normal Moderate Matched Control' and 'Alectinib: Normal Severe Matched Control'. Same 'Alectinib: Normal Hepatic Function' participant could be included in both 'Alectinib: Normal Moderate Matched Control' and 'Alectinib: Normal Severe Matched Control' arms.
719672|NCT02621034||
719673|NCT02620917||
719674|NCT02620878||
719675|NCT02620787||
719676|NCT02620774||
719677|NCT02620683|Beginning in December 2015 23 subjects recruited for study conducted in the surgery clinic at UNC School of Dentistry|No enrolled subjects excluded.
719678|NCT02620384|147 participants from one local institution (inpatient hospital) were enrolled between October 2015 and November 2017|Participants who signed consent but after further evaluation did not to meet inclusion or met one or more exclusion criteria were not included in the analysis. There were four screen failures following consent.
719679|NCT02620020|The study was conducted at 105 sites in US, CA & EU from 26Jan2016 - 13Sep2017. Of 1,783 participants screened, 563 randomized to 1 of 4 groups stratified by baseline low back pain numerical rating scale (LBP NRS) score (<7, ≥7), duration of chronic LBP (<5, ≥5yrs) & max. Kellgren-Lawrence (K-L) score (≤2, >2) at any knee/ hip joint at screening.|The study consisted of a screening period of up to 30 days & a 7-day pre-randomization period during which pain medication, except study-provided rescue medication, was discontinued. Confirmation of no exclusionary findings on joint on which imaging was performed during screening must have been received before a participant could be randomized.
719680|NCT02619812|The subjects were recruited from Mayo Clinic in Rochester, Minnesota.|A total of 4 subjects were enrolled. Two subjects were randomized to placebo/placebo, and one subject was randomized to colesevelam/Serum-derived bovine immunoglobulin/protein isolate (SBI). One subject was consented, but never randomized/accrued.
719681|NCT02619799||
719682|NCT02619617||This study was planned to have 2 cohorts using a one-sequence two-period design to compare SOM230 vs. placebo. Two consecutive CH attacks were treated: the first attack was treated with placebo (Period 1) and the subsequent attack was treated with SOM230 (Period 2). However, Cohort 2 was not initiated.
719683|NCT02619591|Patients with chest trauma presenting to the emergency department who were going to get a CT of the chest were eligible|Exclusions were patients who had recieved a chest tube already, or those with known pneumothoraces.
719684|NCT02619409||
719685|NCT02619396||
719686|NCT02619175||
719687|NCT02618928|This observational study was conducted in 69 medical centers in France experienced in the treatment of chronic hepatitis C (CHC). The first participant entered the study on 15 December 2015, last patient last visit was on 29 March 2018.|
719688|NCT02618915||
719689|NCT02618772|Recruitment began on January 13, 2010 and was completed on March 17, 2015. Recruitment took place solely in the Pediatric Emergency Department at the Montreal Children's Hospital.|
719690|NCT02618759||
719691|NCT02618642|"60 participants meeting inclusion criteria (healthy volunteers) were randomized into 4 groups
~Setting: Centre for Innovative Research in Medical and Natural Sciences, the University of Rzeszów Faculty of Medicine, Poland."|
719692|NCT02618512||
719693|NCT02618187||
719694|NCT02618031||Final assignment to a group was not determined until the diagnostic cerebral angiograms were evaluated by the core lab at the end of the study to quantify the Capillary Index Score for each subject. Preliminary assessment of group was determined by the operators at the time of treatment.
719695|NCT02617901||
719696|NCT02617888||101 patients enrolled in intervention arms (breast shields). Other patients in observational arm (not completed analysis).
719697|NCT02617784||
719698|NCT02617667||
719699|NCT02617628|Recruitment started August 2016 and ended June 16, 2018 in the Philadelphia Prison System. Subjects all were recruited while incarcerated.|Subjects were stratified to sentenced/not sentenced and male/female
719700|NCT02616900|51 participants selected from the patient population at six low vision rehabilitation clinics, in the period Dec 16, 2015 through September 19, 2016.|The study had only one arm.
719701|NCT02616783|Participants were enrolled at study sites in Europe. The first participant was screened on 22 December 2015. The last study visit occurred on 21 March 2018.|214 participants were screened.
719702|NCT02616614||The populations for this study included the Safety Population, the Per-Protocol Population (PP), and the modified Intent-to-Treat (mITT) Population.
719703|NCT02616601||The populations for this study included the Safety Population, the Per-Protocol (PP) Population, and the modified Intent-to-Treat (mITT) population.
719704|NCT02616523|The study was conducted between June 2014 and April 2015 at Ljubljana University Medical Centre, Slovenia.|We excluded from the study: the participants with allergies to α2 receptor agonists, uncontrolled arterial hypertension, 2nd and 3rd degree atrioventricular block, alcohol abusers, clinically important neurological, cardiovascular, respiratory, renal, liver, and gastrointestinal disease, pregnant women and participants younger than 18 years.
719705|NCT02616380|One hundred participants with rheumatoid arthritis (RA) were enrolled at 7 sites in Taiwan.|
719706|NCT02616250||
719707|NCT02616146|Note: One participant less than 18 years of age was inadvertently randomized and received study medication. She was discontinued from the study due to the major protocol violation.|
719708|NCT02616029|Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 17 December 2015. The last study visit occurred on 11 July 2019.|120 participants were screened.
719709|NCT02615990||
719710|NCT02615743||Children were the participants enrolled in the study, parents/caregivers were not.
719711|NCT02615717||
719712|NCT02615535||
719713|NCT02615509||
719747|NCT02612909|Phase 2 & 3: Recruitment occurred from communes affiliated with the District Health Centers. Commune health workers identified potential participants through home visits and invited interested people to attend an information session. People heard about the study and those interested had individual consent for screening.|
719748|NCT02612857||
719749|NCT02612779||EPd cohort: 68 participants entered the treatment period. EN cohort: 6 participants entered the treatment period.
719714|NCT02615470|Community pharmacies in Montgomery, Jefferson, Mobile, Tuscaloosa, Lee (AL) and San Bernadino, Riverside, Los Angeles, San Diego in CA were identified using Hayes Directory. Pharmacies were recruited via telephone with a maximum of 5 contact attempts. Eligible pharmacies must offer at least pneumococcal or herpes zoster vaccination service.|A randomized block design was used. Eligible community pharmacies within each block (AL and CA) were randomly assigned to each treatment group. Pharmacies with the same ownership were assigned to the same treatment group to prevent potential contamination.
719715|NCT02615249|The study population will consist of subjects with past positive patch test result to at least one of the dilution series metals being tested on this study or strong suspicion of metal contact allergy.|Subjects with a past positive patch test will be tested with the allergen panel and corresponding reference allergen(s) to which they had the previous response. Subjects with suspicion of metal contact allergy will be tested with all dilution series and reference allergens. Not all subjects tested all allergens
719716|NCT02615158||
719717|NCT02615145|In this prospective, multi-center observational study, adult patients chronic hepatitis C (CHC) virus receiving the interferon-free ABBVIE REGIMEN (paritaprevir/r - ombitasvir with or without dasabuvir) with or without ribavirin (RBV) were offered the opportunity to participate in this study during a routine clinical visit at participating sites.|Per protocol, the Enrolled Population is used to present Participant Flow. Enrolled Population analysis groups are defined according to the participant's HCV genotype/subtype, regardless of ABBVIE Regimen prescribed.
719718|NCT02614924|Patients were recruited between 27.11.12 till 24.7.14. Recruitment was done during anaesthetic prep assessment.|No participants were excluded
719719|NCT02614898||Sixty-seven participants were enrolled in this study (15 pediatric and 52 adults). Treatment information was missing for 1 adult participant.
719720|NCT02614794||
719721|NCT02614729|All participants were recruited from Columbia, Missouri and the surrounding area from January 2014 to May 2015.|Following recruitment and screening, 17 met women met the screening criteria, signed the study consent, and completed the study procedures. All participants received the following treatments: Energy Balance Comparison (n=17) (SP-PLANT, SP-BEEF, HP-BEEF-EVEN, HP-BEEF-SKEW) & Energy Restriction Comparison (n=17) (SP-PLANT, SP-BEEF, HP-BEEF-EVEN).
719722|NCT02614703|Patients were recruited from our Barrett's esophageal Surveillance Program. The study took place in a South Texas Gastroenterology office. The first patient was enrolled 4-11-17. Study enrollment was stopped 7/30/18.|Patients were assigned an arm immediately after enrollment. There were no events within the enrollment and the actual procedure. The only reason patient could have been excluded was a no-show to the procedure appointment.
719723|NCT02614690|60 patients between ages 3 to 13 with closed shaft or distal third radius and ulna fracture requiring reduction were enrolled at Connecticut Children's Medical Center Emergency room between 2013 and 2015.|There were no pre-assignment details.
719724|NCT02614586|Participants took part in the study at 1 investigative site in the United States from 09 December 2015 to 29 April 2016.|Participants with a diagnosis of schizophrenia were enrolled in this 2-part study comprised of Part-1, screening and Part-2, treatment phase. Part-2 was not initiated because in Part-1 (sequential step 2), the P50 auditory gating (stimulus[S]2/S1) ratio for alpha and beta frequency bands demonstrated high variability and the study was terminated.
719725|NCT02614560||
719726|NCT02614469|Subjects took part in the study at one investigative site in the United States from 15 March 2016 to 10 April 2016.|
719727|NCT02614287||
719728|NCT02614274||
719729|NCT02614261||Results reported are for primary outcome, which is the double blind treatment phase up to month 3; data beyond month 3 will be reported after Study Completion final analysis for month 16 results.
719730|NCT02614222||
719731|NCT02614196||
719732|NCT02614183||
719733|NCT02614131||Following the enrollment of 7 participants into Part B Cohort 5, a decision was made to stop the development of LY2599666 based on the lack of efficacy results of another compound directed against the same target. Participants were not enrolled for Part B Cohorts 6 and 7 or Part C Cohorts 8 and 9.
719734|NCT02614079|Participants were recruited from subjects scheduled to receive the Spinal Cord stimulator (SCS) trial leads at the University of Toledo Medical Center.|6 participants were enrolled.
719735|NCT02613910|This study was a multicounty, multicenter, open-label extension study to assess the long-term efficacy and safety of ofatumumab subcutaneous (SC) injection in participants with pemphigus vulgaris (PV), who completed the core study period of study OPV116910.|The study consisted of a screening visit, followed by a 56-week treatment period, a 4-week follow-up visit and a minimum of 1 year (up to 2 years) of individualized follow-up. Only 1 participant was enrolled into the study due to study termination.
719736|NCT02613897||
719737|NCT02613871|Participants were enrolled at study sites in Taiwan. The first participant was screened on 22 December 2015. The last study visit occurred on 07 November 2018.|135 participants were screened.
719738|NCT02613572||"Phase I: 15 subjects took escalating ALA doses (600mg, 800mg, 1200mg). 1 subject withdrew after 800mg due to wanting to delay start of 1200mg dose beyond planned completion date.
~Phase II: 52 subjects randomized to placebo or 1200mg ALA. 1 subject died due to unrelated event and was replaced in study; thus, 53 total subjects were enrolled."
719739|NCT02613507|The enrollment period lasted approximately 12 months from Dec-2015 until Nov-2016.|639 sbjts were enrolled at 32 sites in China, Russia, and Singapore. 5 sbjts screen failed. The 5 sbjts who screen-failed were re-enrolled. 504 randomized sbjts comprised the randomized population (451 in China, 45 in Russia, and 8 in Singapore). The 451 randomized sbjts who were recruited from China comprised the China Cohort.
719740|NCT02613481||
719741|NCT02613403|"For study Part A, 94 cirrhotic (C) or non-cirrhotic (NC) participants with chronic hepatitis C virus (HCV) genotype (GT) 1 previously failing a direct-acting antiviral regimen (DAA) were randomized, with 1 participant withdrawing prior to receiving study treatment.
~The trial was terminated prior to participant enrollment for study Part B."|
719742|NCT02613338||
719743|NCT02613221|Participants took part in the study at 25 investigative sites in Japan, from 08 December 2015 to 30 March 2018.|Participants with a historical diagnosis of RAS wild-type, unresectable, advanced/recurrent colorectal cancer were enrolled in this study.
719744|NCT02613208||
719745|NCT02613182||
719746|NCT02613117||
719759|NCT02611882|Participants were recruited through clinicians located at San Francisco Veteran's Affairs Medical Center and University of California, San Francisco Helen Diller Family Comprehensive Cancer Center|
719760|NCT02611830|Participants took part in the study at one hundred forty-one investigative sites in North America, South America, Western/Northern Europe, Central Europe, Eastern Europe and Africa/Asia/Australia from 18-Dec-2015 to 21-Aug-2018.|A total of 383 participants were enrolled in open-label (OL) induction phase, 353 participants completed. 216 participants achieved clinical response at Week 6 were randomized into maintenance phase and participants who did not achieve clinical response at Week 6, received 3rd dose of open label vedolizumab IV 300 mg and completed Week 14 visit.
719761|NCT02611817|Participants with moderate to severe Crohn's disease (CD) took part in the study at 169 investigative sites in North America, South America, Western/Northern Europe, Central Europe, Eastern Europe, East Asia, and Africa/Australia from 04 Jan 2016 to 06 Aug 2019.|Participants were enrolled in open-label (OL) induction phase to receive vedolizumab (VDZ) intravenous (IV). Participants with clinical response (CR) at Week 6 were randomized into double-blind maintenance phase to receive VDZ subcutaneous/placebo, and who did not achieve CR at Week 6 received 3rd infusion of OL VDZ IV and completed Week 14 visit.
719762|NCT02611765||
719763|NCT02611752||
719764|NCT02611479||If participants did not complete a baseline survey before their lumbar spine fusion surgery or were found to be ineligible they were excluded from the study before completing follow-up surveys.
719765|NCT02611154|Recruitment for this study began in November 2015 and ended December 2015. The final participant was enrolled on 03DEC2015 and completed the study on 19JAN2016.|
719766|NCT02610972||
719767|NCT02610868|Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.|All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).
719768|NCT02610842|Patients with SSc were invited to take part in this study during their routine appointments at University of Campinas Rheumatology Outpatient Clinic.|Patients were excluded if enrolled in other rehabilitation program in the previous three months, in the presence of hand disability due other pathologies rather than Systemic Sclerosis, or if they could not perform the exercises proposed as intevention due to medical conditions or advanced hand deformities.
719769|NCT02610816|Participants were recruited from eosinophilic esophagitis (EoE) specialty clinics (10 sites) in the USA between November 2015 and February 2018.|67 participants screened, 4 excluded (2 did not meet inclusion criteria, 2 met exclusion criteria), and 63 randomized
719770|NCT02610777|Participants took part in the study at 59 investigative sites in the United States, Canada, Belgium, Bulgaria, Czech Republic, Germany, Spain, France, Ireland, Israel, and Italy. Results are reported based on the primary completion date of 04 September 2019.|Participants with higher-risk myelodysplastic syndrome (HR MDS) or chronic myelomonocytic leukemia (CMML) or low-blast acute myelogenous leukemia (AML) were enrolled in this study to receive one of the two treatments: single-agent azacitidine or the combination of pevonedistat and azacitidine.
719771|NCT02610725||
719772|NCT02610634||
719773|NCT02610231||Subjects must have completed 12 weeks of double blind treatment in study 6002-014 including a 30 day follow up period. All subjects were screened for eligibility to participate in the trial. Subjects that met all the inclusion and none of the exclusion criteria were eligible for entry into the trial.
719774|NCT02610192|The study is conducted at a single center in Deurne (Belgium).|
719775|NCT02610140||Overall, 315 patients were screened; of these, 67 patients were screening failures.
719776|NCT02609984||
719777|NCT02609841|Patients with end stage renal disease on maintenance hemodialysis took part in the study at 17 sites in the United States.|Cardiac rhythm was monitored using a 24-hour non-invasive, wearable device (BodyGuardian® remote monitoring system) throughout the study to assess for cardiac arrhythmias was to be worn by patients. One site did not perform cardiac rhythm monitoring.
719778|NCT02609672||
719779|NCT02609659||
719780|NCT02609633|Families of participants were identified and recruited from the investigators' established participant populations or from the participant populations of other physicians within the group practice, using protocol-specified inclusion and exclusion criteria.|Although a total of 196 parents and children/adolescents were enrolled, only the 98 children/adolescents were considered participants in the study. Baseline and adverse events data were only collected for children/adolescents.
719781|NCT02609607||
719782|NCT02609399|"This study recruited adult patients through both clinical testing and screening with a Clinical Decision Guideline (CDG) over two influenza seasons at the following academically affiliated U.S. Emergency Departments (EDs):
~November 2015- April 2016: Johns Hopkins Hospital (JHH)
~November 2016- April 2017: JHH and Maricopa Medical Center (MMC)"|
719783|NCT02609308||
719784|NCT02609204||
719785|NCT02609178|All the participants were enrolled from the Department of Prosthodontics, Stomatological Hospital of Fourth Military Medical University between December 2015 and March 2016.|17 patients assessed for eligibility, 5 of them were excluded for not meeting inclusion criteria. 12 participants recruited; 10 screened.
719786|NCT02609113||
719787|NCT02609100||
719788|NCT02608905||
719789|NCT02608892|Recruitment took place between May and August 2016, at a mother-baby unit in Ontario, Canada.|No enrolled participants were excluded from the study before assignment to groups.
719790|NCT02608879||
719791|NCT02608684||
719792|NCT02608489|Consecutive patients aged 20-90 years with bilateral or unilateral cataract undergoing uncomplicated phacoemulsification and intraocular lens (IOL) implantation at Soonchunhyang University Hospital between January 1, 2014 and January 31, 2015 were enrolled.|
719793|NCT02608476||
719794|NCT02608463||
719795|NCT02608450||
719796|NCT02608229|The study opened to participant enrollment on 06/06/2016 and closed to participant enrollment on 08/19/2019.|
719797|NCT02608177||
719798|NCT02608099||
720200|NCT02569411|Authors identified in randomized controlled trials that were eligible for inclusion in two systematic review and network meta-analysis papers.|Authors whose contact information was unidentifiable were excluded.
719799|NCT02607956|Participants were enrolled at centers in Australia, Europe, North America, and the Dominican Republic. The first participant was screened on 11 November 2015. The last Week 144 study visit occurred on 17 May 2019.|742 participants were screened.
719800|NCT02607930|Participants were enrolled at study centers in Europe, Canada, Dominican Republic, and United States. The first participant was screened on 13 November 2015. The last Week 144 study visit occurred on 14 May 2019.|739 participants were screened.
719801|NCT02607865|The trial was conducted at 200 sites in 14 countries: Argentina-5, Brazil-1, France-10, Germany-12, Israel-8, Japan-16, Mexico-5, Romania-12, Russian Federation-8, South Africa-11, Turkey-7, Ukraine-8, United Kingdom (UK)-14, United States (US)-83. In addition, 6 sites screened, but didn't randomise any subjects: France-1, Turkey-1, UK-1 and US-3.|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
719802|NCT02607800|Participants were enrolled at study sites in North America, Europe, and, Asia Pacific. The first participant was screened on 16 November 2015. The last study visit occurred on 11 January 2017.|1116 participants were screened.
719803|NCT02607735|Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 11 November 2015. The last study visit occurred on 21 June 2017.|520 participants were screened.
719804|NCT02607618||
719805|NCT02607306|The trial was conducted at 71 sites in Japan. 71 sites screened and randomised subjects.|
719806|NCT02607280|A total of 35 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study from December 2015 to March 2017 at 1 clinic site in Japan.|
719807|NCT02607254|11 subjects were recruited in the study.|Each subject underwent a washout period to stop the the current pain medications. Subjects who had significant reduction in pain were randomized to either placebo or Lyrica during the double blind withdrawal phase.
719808|NCT02607228|Participants were enrolled at 4 study sites in the United States. The first participant was screened on 08 December 2015. The last study visit occurred on 03 September 2019. Phase 2 Dose Expansion of the study was not conducted. Results are reported for only Dose Escalation Monotherapy and Combination Therapy.|43 participants were screened.
719809|NCT02607124||
719810|NCT02606903||This was randomized, single-dose, parallel-arm, open-label Phase I trial with healthy male subjects.
719811|NCT02606877|This was an open-label, multiple-dose, 2-group trial in patients with idiopathic pulmonary fibrosis (IPF) to investigate the relative bioavailability of nintedanib and pirfenidone when administered alone and after coadministration.|Each patient group was treated according to a fixed sequence design, first with single treatment (R1, R2 respectively) followed by a combined treatment (T1, T2 respectively) which also included an up-titration period. Therefore, generating individual participant flow for each treatment group was not planned in this trial.
719812|NCT02606838||
719813|NCT02606734|First Enrollment on 10/26/2015, Last Enrollment on 11/19/2015|Subjects undergoing a coronary artery imaging (angiogram) for diagnostic or percutaneous coronary intervention (PCI) procedures are eligible to participate in this study. All data will be collected on the day of the procedure. There are no follow-up visits in this study.
719814|NCT02606708||
719815|NCT02606643||
719816|NCT02606604|PWMS were recruited from various sources from including: physician practices, physical therapy practices, support groups, web postings, email, fitness centers, and personal communication. Recruitment was from June 2015 - July 2017.|Participants were excluded from the study if they did not meet the inclusion/exclusion criteria.
719817|NCT02606500||
719818|NCT02606279||
719819|NCT02606253||
719820|NCT02605993||
719821|NCT02605954|Participants were enrolled at study sites in Europe and North America. The first participant was screened on 18 November 2015. The last study visit occurred on 24 Jan 2018.|346 participants were screened.
719822|NCT02605928|First punctures were utilized for tissue detection model validation and tuning. In pivotal phase, the model kept unchanged. Performance of the device was evaluated from pivotal phase results.|
719823|NCT02605876|A convenience sample was recruited from local rehabilitation clinics, the University population, the local population, and a nearby Veterans Affairs Medical Center.|
719824|NCT02605863||
719825|NCT02605837|This study was conducted at 72 sites in North America from 07 December 2015 (first participant enrolled) to 15 February 2019 (last participant completed).|A total of 318 participants were randomized and received the treatment (placebo or oral Budesonide suspension [OBS]) in a double blind fashion following a placebo lead-in phase and 296 participants completed the study.
719826|NCT02605824||9 subjects were consented to the study but only one remained eligible to continue to the treatment period after baseline eligibility testing and the run-in period.
719827|NCT02605642|351 participants were included in this study, however, 17 participants were excluded from all analysis (they were neither BDMARD naive nor switched from Remicade). They switched to CT-P13 from a BDMARD other than Remicade, therefore not considered for any analysis.|
719828|NCT02605447|There were 2009 subjects enrolled at 110 centers in USA, Japan, Germany, Sweden, Brazil, Latvia and Switzerland between 16 February 2016 and 30 March 2018.|2009 patients are enrolled, but 522 patients did not stop the DAPT therapy. Therefore 1487 patients are counted as eligible for the study endpoints.
719829|NCT02605395|Bioequivalence of rabeprazole from Idiazole 20 milligram (mg) tablets and Pariet 20 mg tablets was investigated after single oral dose administration to healthy participants under fed conditions. This study was conducted from 22 March 2014 to 30 March 2014.|During this study, 74 participants were screened. One participant was excluded for significant variation in laboratory results at screening and three participants voluntarily withdrew before entering in to period 1. Hence, 70 participants were enrolled and randomized in study, and all 70 participants completed both periods of the study.
719830|NCT02605304|Participants were enrolled from February to June 2016 at 3 U.S. sites.|
719831|NCT02605187||
719832|NCT02605174||Participants were randomly assigned to 1 of 7 sequences and received lasmiditan 50 mg (L50 mg), lasmiditan 100 mg (L100 mg) or lasmiditan 200 mg (L200 mg) or placebo (P) for the first dose and the second dose, if needed for rescue or recurrence of migraine.
719833|NCT02605122|Subjects who met all inclusion/exclusion criteria and sign the informed consent/assent were enrolled. Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects received safety and efficacy assessments during and after treatment.|
719834|NCT02604810|A total of 61 subjects were screened for participation in this study. Of these 61 subjects, 8 subjects were considered screen failures. A total of 20 investigators in the United States enrolled subjects in this study. The first subject was enrolled in this study on 04 Jan 2016 and the date of the last subject's last study visit was 14 Dec 2017.|One subject was lost to follow-up before the IGIV-C Phase.
719835|NCT02604589||
719836|NCT02604550|Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center in Atlanta, Georgia were prospectively randomized to receive either a femoral nerve block (FNB) or an adductor canal block (ACB). Participants were enrolled between December 2015 and April 2016.|
719837|NCT02604433|A total of 447 subjects were screened for inclusion in this study, of whom 336 participants were randomized to study treatment at 65 sites in 15 countries. Screening/run-in evaluations were performed to determine study eligibility and were completed within 12 weeks of randomization.|Participants were randomized to receive luspatercept or placebo at a 2:1 ratio, stratified by geographical regions: • North America and Europe • Middle East and North Africa • Asia-Pacific Data Cut-off: 11 May 2018 D/C TRT counts refer to participants who discontinued treatment and continued in the study as part of the Follow-Up Period.
719838|NCT02604407|The study was conducted at 43 study centers in the United States between 19 November 2015 and 24 March 2016.|A total of 369 participants were screened and 275 participants were enrolled in the study.
719839|NCT02604342|The study recruited participants with Anaplastic Lymphoma Kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) in 13 countries from November 2015 to March 2017.|A total of 119 participants were enrolled and randomized into the study: 79 participants in the alectinib arm, and 40 participants in the chemotherapy arm.
719840|NCT02604264||
719841|NCT02604212||
719842|NCT02604199||
719843|NCT02604173||
719844|NCT02604160||In Part A of the study, a dose stopping criterion was met leading to early conclusion of the study.
719845|NCT02604017||This study included a 35-day screening period.
719846|NCT02603952|The study was conducted from 07 Dec 2015 to 09 Dec 2016 in Australia, South Africa and United States of America.|A total of 373 participants were screened, of which 247 participants were screen failures and 126 participants were randomized in the study.
719847|NCT02603926|Participants were recruited by invitation from the University of California, Davis (UC Davis), MIND Institute's Fragile X Research and Treatment Center.|
719848|NCT02603887|Enrollment period was between July 20, 2016 and August 22, 2017|13 participants were treated at MD Anderson Cancer Center. 7 participants who consented were not treated; 3 due to multiple myeloma (MM) diagnosis, 1 had monoclonal gammopathy of unknown significance (MGUS) diagnosis, 2 withdrew consent due to personal preference and 1 didn't get treatment due to study was placed on hold by FDA
719849|NCT02603809|The study was conducted at 99 sites in 3 countries. Of the 1659 participants that signed the informed consent 996 entered the run-in period (i.e. 663 participants were screening failures: 651 failed to meet the eligibility criteria to enter the run-in period, 6 withdrew and 6 did not enter the run-in period for other reasons).|Of the 996 participants enrolled into the run-in period, a total 992 participants received at least one dose of the single-blind placebo. Of these 992 participants 502 were considered run-in failures (390 failing to meet randomization criteria, 57 withdrew consent and 55 left for other reasons) and 490 participants were randomized into the study.
719850|NCT02603666|Outpatient department, between 04/Feb/2012 and 04/Apr/2014|
719851|NCT02603432|This study included only those participants who did not show evidence of disease progression after completion of at least 4 and not more than 6 cycles of first-line platinum-containing chemotherapy (prior to this study).|
719852|NCT02603419||Study was conducted in 2 phases: lead-in and expansion. Expansion phase was terminated by the sponsor on 30 April 2018.
719853|NCT02603393||
719854|NCT02603211||
719855|NCT02603172|Participants took part in the study at one investigative site in the United Kingdom from 12-May-2016 to 10-May-2017. The study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4A and 4B were not recruited in Part B and Part C was not initiated.|This was 3 parts study, participants received GSK3039294: single ascending dose in Part A; repeated dose in Part B; repeat dose in systemic amyloidosis in Part C. Participants in Part A also participated in Part B of the study.
719856|NCT02603120|Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 11 November 2015. The last study visit occurred on 23 October 2019.|646 participants were screened.
719857|NCT02603107|Participants were enrolled at study sites in Dominican Republic, North America, Australia, and Europe. The first participant was screened on 20 November 2015. The last study visit occurred on 23 December 2019.|707 participants were screened.
719858|NCT02602496||
719859|NCT02602223|Screening, recruitment and study-related procedures were done at Indiana University School of Dentistry (IUSD) clinics between 9/17/2012 and 7/14/2014|
719860|NCT02602080||55 patients were enrolled in the study based on the anesthesia they will be receiving and their surgical type. Patients weren't excluded prior to group assignment. Patients were excluded if protocol deviations occurred, pending the severity of the deviation.
719861|NCT02601976||
719862|NCT02601820|"11 liver or gastroenterology centers in the United States: 9 academic medical centers, 2 private gastroenterology centers.
~1601 patients officially enrolled who provided informed consent, completed baseline patient-reported outcome (PRO) surveys and were prescribed one of five direct acting antiviral treatment regimens for chronic hepatitis C."|None. Observational study included enrolled patients who completed PRO data at follow-up time periods.
719863|NCT02601625|"This study was conducted at the PAREXEL Early Phase Clinical Unit Baltimore, 3001 S. Hanover St.
~Baltimore, MD 21225 United States of America"|All eligible participants underwent a screening period of a maximum of 28 days. During the treatment period all participants were asked to be the residents at the study site prior to the evening meal the night before dosing with anifrolumab or placebo (Day -1) until at least 48 hours after dosing; and were then discharged on the morning of Day 3.
719864|NCT02601573|Adult participants infected with HCV GT3 were enrolled at 14 study centers in the United Kingdom.|A total of 101 participants were randomized, including 1 participant who did not meet inclusion criteria and who should have been considered a screen failure; this participant was not treated with study drug. A total of 100 participants were treated.
719865|NCT02601560|A total of 230 participants were screened in the study from 07-Dec-2015 to 13-Jan-2017 at 8 sites in the United States of America.|Out of 230 participants, 182 participants were considered screen failures. The remaining 48 participants were randomized to receive the study drug. The 1600 mg dose was omitted based on a greater than expected pharmacodynamics effects at lower doses.
719866|NCT02601469||
719867|NCT02601313|Participants were enrolled at study sites in United States, France, Netherlands and Germany. The first participant was screened on 09 Nov 2015. The data cutoff occurred on 24 July 2019.|Participants from 2 x 10^6 axicabtagene ciloleucel (AC) didn't contribute to primary and secondary analysis. The process used to manufacture axicabtagene ciloleucel was modified to manufacture brexucabtagene autoleucel (KTE-X19). 10 participants were treated with axicabtagene ciloleucel, all other participants were treated with KTE-X19.
719868|NCT02601300|Participants were enrolled at 21 study centers within the United States, Bulgaria, Poland, Slovakia and Canada.|Participants were 18 years of age and older with active ulcerative colitis for 3 months prior to screening, had a modified Mayo score (MMS) ≥ 4 to ≤ 9 absolute rectal bleeding (RBS) subscore ≥ 1 at screening, a mayo endoscopic subscore ≥ 2 at screening and must have had a therapeutic failure or been intolerant to other therapies.
719869|NCT02601209||"Phase II Analysis Group 1: 32 Patients pre-registered; 7 did not pass screening, leaving 25 to proceed to randomization.
~Phase II Analysis Group 2: 166 Patients pre-registered; 52 did not pass screening, leaving 114 to proceed to randomization."
719870|NCT02601170||
719871|NCT02600923||A total of 131 participants were enrolled and assigned to study treatment, and 130 participants were treated in the study.
719872|NCT02600871||
719873|NCT02600845|Participants were identified and recruited from the investigators' established subject populations or from the subject populations of other physicians within the group practice, using protocol-specified inclusion and exclusion criteria.|
719874|NCT02600819|Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 14 December 2015. The last study visit occurred on 15 October 2019.|75 participants were screened.
719875|NCT02600767||
719876|NCT02600715|Recruitment began December 1, 2015 at a private urogynecology clinic. There were 32 patients that were assessed for eligibility. Four patients were excluded: three patients did not meet inclusion criteria (did not proceed with in-office treatment) and one patient declined to participate due to wanting the active suppository.|"28 patients consented to participate in the study. Two patients withdrew consent to participate and did not end up participating: one patient's medication resumed efficacy, and one patient withdrew regarding possible use of narcotics and concern due to a a previous narcotic addition.
~Thus, only 26 patients are considered enrolled in this study."
719877|NCT02600637||
719878|NCT02600611||
719879|NCT02600559||"There were a total of 518 subjects screened for this study. There were 17 subjects considered screen failures, with the majority (11) failing to meet inclusion/exclusion criteria. Therefore, 501 subjects were assigned for treatment in this study and are designated as enrolled."
719880|NCT02600403||
719881|NCT02600351|Participants were enrolled at study sites in the United States (including a site in Puerto Rico), and Canada. The first participant was screened on 11 November 2015. The last study visit occurred on 29 May 2017.|120 participants were screened.
719882|NCT02600325||
719883|NCT02599961|Study enrolled pediatric, adolescent, and adult glucose transporter type 1 deficiency syndrome (Glut1 DS) participants who completed the UX007G-CL201 study (NCT01993186; rollover participants). No non-rollover participants (those from other clinical studies, investigator sponsored trials, or expanded access/compassionate use treatment) enrolled.|For continuing UX007G-CL201 participants, the Week 52 visit of that study may have been conducted in conjunction with the Baseline visit for this study to avoid duplication of assessments.
719884|NCT02599766||
719885|NCT02599688||
719886|NCT02599649|Recruitment Period: April 2016 to June 2017|Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.
719887|NCT02599441||
719888|NCT02599194||
719889|NCT02599129|Subjects were enrolled from November 2015 to March 2016.|
719890|NCT02598934||
719891|NCT02598622||
719892|NCT02598583||
719893|NCT02598297|Approximately 320 male or female adults (age 18 or over) with a confirmed diagnosis of MF were planned to be enrolled. The target population was not met due to early study termination. A total of 49 subjects were enrolled in the study, 25 in the ruxolitinib arm and 24 in the placebo arm.|
719894|NCT02598193|Participants with idiopathic pulmonary fibrosis were recruited for this study.|At the start of screening, participants were on pirfenidone for at least 16 weeks and on a stable dose (1602-2403 mg/d) for at least 28 days. A total of 109 participants were screened, 20 participants were screen failures and 89 were enrolled at 36 study centers in 8 countries.
719895|NCT02598128|34 patients enrolled; 33 patients completed the study from 11 U.S. sites.|33 eligible patients according to the inclusion/exclusion criteria were randomized in Period B (double-blind crossover) to the study.
719896|NCT02598089||Sixty four (64) subjects were consented and 4 were not randomized, leaving 60 subjects for the study.
719897|NCT02598076||
719898|NCT02597946|Open label, single arm study, divided into 2 parts; Part A: All enrolled patients will receive afatinib monotherapy.Part B: Patients with more than 12 weeks clinical benefit in part A will receive afatinib once daily combined with paclitaxel once weekly.|No patients met the criteria to enter part B. Thus part B was not performed in this trial.
719933|NCT02595502||A total of 286 subjects were enrolled in this study. Of the enrolled subjects 1 subject did meet the eligibility criteria and 285 subjects were randomized. Of the randomized subjects 9 were discontinued and 276 completed the study.
720286|NCT02561130||
719899|NCT02597933|"This was a randomised, placebo-controlled, double-blind, parallel design trial.
~Abbreviation used:
~treatment (trt) baseline (bl.) categorical (cat.) continuous (cont.) number (no.) patient (pt) Placebo (pl.) discontinued (disc.) primary analysis (PA) Antitopoisomerase Antibody (ATA)"|All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated
719900|NCT02597920|Non-interventional study (NIS) on patients diagnosed with non-valvular atrial fibrillation (NVAF).|A total of 1852 patients were enrolled, out of which 1822 were found eligible.
719901|NCT02597907||
719902|NCT02597855||
719903|NCT02597673||2 participants withdrew from the study during baseline testing, and prior to being assigned to a group.
719904|NCT02597582||
719905|NCT02597543||
719906|NCT02597478|Adult participants (age>18) with an active diagnosis of cancer were recruited between 1/2016 and 10/2018 from the Supportive Care and Thoracic Medical Oncology outpatient clinics at MD Anderson Cancer Center who met the inclusion and exclusion criteria.|A total of 50 participants enrolled but 34 patients were randomized to start the study. 13 became symptomatic while on wait list and could not proceed, 2 participants died, and 1 had screen failure before participants were randomized.
719907|NCT02597452||
719908|NCT02597127||
719909|NCT02597062||
719910|NCT02597049||
719911|NCT02596971|The study was conducted at 15 sites in 3 countries (Italy, Australia, and USA).|Out of the 117 subjects who were screened for this study, 91 subjects were enrolled to either FL treatment cohort (Atezo-G-Benda, Atezo-G-CHOP) or DLBCL cohort (Atezo-R-CHOP) and 26 subjects failed screening.
719912|NCT02596958||
719913|NCT02596945||
719914|NCT02596906|32 participants consented for the study of which 15 were included in the final analysis.|331 participants were screened for eligibility criteria, of which 52 participants were eligible for the study. Of the 52, 20 participants dropped out due to time constraints. An additional 17 participants were removed from the analysis due to inability to complete the scans or after recommendation by neurologist who questioned if they truly met eligibility criteria.
719915|NCT02596893|Participants were enrolled at study centers within the United States and Canada, Australia, Eastern and Western Europe, Korea and Russia.|Treatment assignment at baseline (Week 0) was stratified based on concomitant use of corticosteroids (yes/no), concomitant use of immunosuppressants (yes/no) or and previous exposure to biologics (yes/no),
719916|NCT02596867|Prospective - two breast cancer patients enrolled over 6 months perios from clinic .|
719917|NCT02596854||A single arm of subjects was enrolled and analyzed. Scanner selection (1.5T or 3.0T) was based on availability at the site and assigned by the site. Only one arm assignment (neurological MRI population) was per-protocol.
719918|NCT02596750||Measure Analysis Population Description: This study incorporated a split body design. 21 participants were studied, each participant had a different treatment on each of their forearms, 42 forearms or data points overall.
719919|NCT02596711|Participants were recruited from the Houston metropolitan area (Harris County, Texas) through fliers at community centers and local health clinics as well as through advertisements online and in print newspapers between February of 2016 and January of 2017.|During baseline visit (prior to randomization), an expired carbon monoxide sample was collected using Bedfont Micro+Smokerlyzer.Additionally, participants able to become pregnant were required to take a routine hCG urine sample pregnancy test to rule out potential pregnancy.An assessment battery was also administered at the baseline visit.
719920|NCT02596620|164 patients who had failed the H pylori eradication attempts using the standard triple therapy (proton pump inhibitor bid, clarithromycin 500 mg bid, amoxicillin 1 g bid × 7 days) were randomly assigned to either an sequential therapy group (EALM)(n = 82) or a 10-day levofloxacin-containing teriple therapy group (EAL)(n = 82).|We excluded those patients who had taken antibiotics, bismuth, proton-pump inhibitors, or non-steroidal anti-inflammatory drugs within the previous 4 weeks, were allergic to the medications used, had a history of previous gastric surgery or serious concomitant illness, or were currently pregnant.
719921|NCT02596451||
719922|NCT02596321||
719923|NCT02596230|This study characterizes patients following acute venous thromboembolism and assesses the safety and effectiveness of dabigatran etexilate in the treatment and secondary prevention of acute DVT and PE in comparison to vitamin K antagonist in routine clinical practice. This is a large multi-center observational study based on new data collection.|All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they met all inclusion/exclusion criteria. The study enrolled and characterized all patients within 30 days after being diagnosed with an acute DVT and/or PE.
719924|NCT02596035||197 participants were enrolled, 142 were treated. Of the 55 participants not treated, 3 participants withdrew consent, 2 participants died and 50 participants no longer met study criteria.
719925|NCT02596022||
719926|NCT02596009|Out of the 97 screened and randomized patients, 96 patients (99.0%) completed the study.|No active drug or placebo was administered in this study. The patients were to continue on their respective current maintenance COPD treatment as deemed appropriate by the treating physician. Each patient was required to inhale through all three study devices at the same visit in a randomized cross-over sequence.
719927|NCT02595983|A total of 12 participants with hereditary Transthyretin-mediated Amyloidosis (ATTR) with polyneuropathy who had neuropathy progression following post-orthotopic liver transplant (OLT) were enrolled and treated in this study.|
719928|NCT02595970|"Study centers: This study involved 17 active centers who enrolled (or recruited) patients in France
~First patient enrolled: 20-May-2015
~Last patient completed: 09-Feb-2017"|No significant events in the study (for example, wash out, run-in) that occur after participant enrollment, but prior to assignment of participants to the treatment arm
719929|NCT02595723|35 patients were screened for eligibility between July 2015 and September 2016.|21 of 35 participants were randomized. Of those not randomized, 14 did not meet inclusion criteria.
719930|NCT02595684||
719931|NCT02595567||
719932|NCT02595528||Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study.
719939|NCT02594826||Following eligibility screening and informed consent, women completed a baseline questionnaire, which included items on screening history and prior medical history. For a small number of women, responses on the baseline questionnaire were deemed to be inconsistent with study eligibility. Therefore, those women were excluded from further analysis.
719940|NCT02594644||
719941|NCT02594163||
719942|NCT02594111||
719943|NCT02594098||
719944|NCT02593903||
719945|NCT02593864||X-ray screening for inclusion/exclusion criteria
719946|NCT02593825||
719947|NCT02593773||
719948|NCT02593630||
719949|NCT02593396|All the male subjects who attended the methadone maintenance clinic from December 2015 to December 2017 in University Malaya Medical Center (UMMC) and University Malaya Center of Addiction Science Studies (UMCAS) were approached.Screening data was reviewed to determine subject eligibility.|This study screened 109 and included 80 (73.4%) male patients who met all inclusion criteria and none of the exclusion criteria.
719950|NCT02593305||
719951|NCT02593149||"Baseline characteristic data were not collected for the participants in the Intervention Period. Baseline data were collected for the Run-In Period with the a priori intent of showing that baseline characteristics were similar in both arms. 9 patients were excluded due to heparin allergies prior to enrollment during the Intervention period."
719952|NCT02593097||
719953|NCT02593032||
719954|NCT02592876||
719955|NCT02592655|Healthy volunteers with a minimum upper thigh circumference of 61 cm were recruited from the general population during the first two weeks of December 2015.|Each participant receives a different intervention each period. 19 Participants randomly allocated to unique sequences of four interventions. No participants were lost once enrolled. 5 minute minimum washout period between interventions.
719956|NCT02592629||
719957|NCT02592486||
719958|NCT02592447||Of 48 consented, 4 never completed questionnaires.
719959|NCT02592434||
719960|NCT02592421||
719961|NCT02592018||
719962|NCT02591537||Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing.
719963|NCT02591511||
719964|NCT02591290|Participants were enrolled from 20 October 2015 through 18 December 2015 at a single center in Japan.|A total of 60 participants were enrolled in the study.
719965|NCT02591238|Time: Jun 10,2015 -Jun 24,2015. Address: factory clinic of Heilongjiang Airports Managements Group Co., Ltd and village clinic of Xinfa village Daoli district, Haerbin city, Heilongjiang province, China. Medical staff: 3 Registered medical practitioner and 4 registered nurse.|First in included 96 participants of both genders, 28 participants excluded (refused to randomly assigned n=9, not meeting inclusion criteria n=9, time improper n=8, unknown n=2). 5 participants withdraw during the trial (pregnant n=1, influenza n=1, personal circumstance n=2, unknown reason n=1).
719966|NCT02591056||
719967|NCT02590939||
719968|NCT02590588||
719969|NCT02590562||
719970|NCT02590432|828 participants were enrolled, 2 participants were enrolled but did not receive study treatment and were not included in any analysis populations.|826 participants received LINZESS® 145μg [CIC] and 290μg [IBS-C] in the Open Label Treatment Period. Out of 826, 114 participants were randomized in the Double-blind Treatment Period and 57 out of 114 participants received 72 μg in the Dose-reduced Open Label Treatment Period due to intolerable AEs.
719971|NCT02590406|Recruitment between September and December 2015 on the bariatric surgery ward during the preoperative assessment.|"Files were evaluated in order to see if the patients met the inclusion criteria, if they had any exclusion criteria. Then the trial was explained to them and they could choose wether they wanted to participate or not.
~75 patients files were evaluated, 53 were solicitated, 3 refused to participate."
719972|NCT02590354||
719973|NCT02590068||
719974|NCT02590003||
719975|NCT02589847||
719976|NCT02589808||
719977|NCT02589665||
719978|NCT02589639|"After screening, patients who were pre-treated with insulin and 1 oral antidiabetic drug (OAD) underwent a 10-week wash-out period.
~Then patients proceeded to a 2-week open-label placebo run-in period. Patients who were pre-treated with insulin alone skipped the wash-out period and proceeded to an open-label placebo run-in period."|Patients who successfully completed the periods and who still satisfied the inclusion/exclusion criteria were randomised to the 52-week double- blind treatment period of the study in which they received either 1 of the 2 doses of empagliflozin or placebo in addition to insulin.
719979|NCT02589626|Patients were entered in the trial and randomised in a 1:1 ratio to receive treatment.|All subjects were screened for eligibility to participate in the trial. Subjects attended specialist site which would then ensure that they (the subjects) met all strictly implemented inclusion/exclusion criteria. Subjects were not randomised to trial treatment if any one of the specific entry criteria was violated.
719980|NCT02589405||
719981|NCT02589171||
719982|NCT02589145|Patients enrolled at MD Anderson Clinic starting on August 22, 2016.|
719983|NCT02589067||
719984|NCT02588976||
719985|NCT02588872||
719986|NCT02588599||
719987|NCT02588573||Of the 103 enrolled, 13 participants were not eligible due to screen failure. This reporting group includes 90 participants (180 eyes) belonging to 2 groups of 45 habitual wearers of either etafilcon A lens or frequent replacement lenses (FREQ). All participants were randomized to wear etafilcon A in one eye and somofilcon A in the fellow eye.
719988|NCT02588339|Participants recruited between March 2016 and August 2018|
720059|NCT02581891|This study was conducted from 19-Nov-2015 (First Patient First Visit) to 26-Apr-2019 (Last Patient Last Visit).|A total of 443 participants were screened in this study. Of these, 156 participants were screening failures and did not enter the treatment period. Of the 287 treated participants, 16 were treated during the initiation phase, but were not randomized to a treatment arm after the initiation phase.
720287|NCT02561078||
720288|NCT02560922||
719989|NCT02588261|First-line participants with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma NSCLC with EGFR activating mutation (exon 19 deletion or exon 21 L858R) with or without a T790M mutation who had not previously been treated with an EGFR inhibitors were enrolled in 201 sites in 23 countries.|Eligible participants were stratified according to the following: Eastern Cooperative Oncology Group (ECOG) performance status (0, 1 or 2), Epidermal growth factor receptor (EGFR) mutation status (exon 19 deletion or mutations in exon 21 [L858R]), Tyrosine kinase inhibitor (TKI) chosen (erlotinib or gefitinib) and race (Asian versus non-Asian).
719990|NCT02588092|Participants were enrolled at 11 sites in the United States between 01 February 2016 and 29 August 2018.|
719991|NCT02587819||
719992|NCT02587650||
719993|NCT02587520|Study participants were enrolled in 20 centers in the Unites States (US) from 22 October 2015 to 15 August 2016.|A total of 1363 participants were randomized in a 1:1:1 ratio to 1 of the 6 formulation study groups. Randomization was stratified by age (adolescents: age 10-18 years, adults: age 19-64 years, and older adults: age greater than equal to [>=] 65 years).
719994|NCT02587234||
719995|NCT02587221|The study enrolled male and female adults ≥ 65 years old who were healthy or had co-morbidities.|Screening criteria applied.
719996|NCT02587143||Seccondary effcts happens after punctre (dizziness...)
719997|NCT02587117|Only symptomatic oral lichen planus patients, who were fulfill inclusion and exclusion criteria, were selected and recruited from the outpatient department of Oral Medicine and Radiology, College of dental surgery, BPKIHS on the basis of randomization list. The first patients was recruited on 21/02/2013 and the last patients was on 28/01/2014.|Before enrollment, full explanation about the study was given and written informed consent was taken. A detailed clinical history, clinical examination,baseline investigations and punch biopsy were taken. Patient was on treatment with medication for the same lesions asked to stop the treatment and a washout period of 3 weeks was given.
719998|NCT02587065|Participants were recruited from 32 sites in Italy.|A total of 193 participants with relapsing remitting multiple sclerosis (RRMS) were enrolled into the study.
719999|NCT02586974|All patients undergoing RARP at Città della Salute e della Scienza Hospital between September 2015 and June 2016 were screened for inclusion.|Exclusion criteria were as follows: age >80 years, ASA status >3, allergic status needing corticosteroid premedication, refusal to sign the informed consent, cognitive disability, conversion to open surgery.
720000|NCT02586909||
720001|NCT02586896||
720002|NCT02586857||
720003|NCT02586805|The study was conducted at 41 sites in the United States, United Kingdom, Italy, Germany, Canada and Jordan between 03 March 2016 (first participant first visit) and 13 April 2017 (last participant last visit).|A total of 159 participants were screened and 126 participants were randomized in the ratio of 3:2:2:2 to the placebo versus DX-2930-03 arms. Of them, 125 participants were assigned to study treatment and one participant determined to be screen failure after randomization.
720004|NCT02586675|Participants were enrolled at Moffitt Cancer Center March 2016 through September 2016. All participants were enrolled and treated on Cohort 1 (Ribociclib 400 mg PO D1-21; Tamoxifen 20 mg PO QD (1) only.|
720005|NCT02586506|Participants who were naive to ELLIPTA (trade name of dry powder inhaler owned by GlaxoSmithKline) inhaler use and had an established diagnosis of asthma participated in this study.|
720006|NCT02586493|Participants who were naive to ELLIPTA (trade name of dry powder inhaler owned by GlaxoSmithKline) inhaler use and had an established diagnosis of Chronic Obstructive Pulmonary Disease (COPD) participated in this study.|
720007|NCT02586415|From May 2016 through May 2017, a total of 182 patients underwent randomization (92 to the endovascular-therapy group and 90 to the medical-therapy group) at 38 centers in the United States.|After obtaining written informed consent, participants were randomized if they met all clinical and imaging eligibility requirements and could undergo initiation of endovascular therapy between 6 and 16 hours after the time that they had last been known to be well.
720008|NCT02586233|A total of 106 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment at a total of 78 clinic sites (46 in Europe, 19 in the United States, 7 in Asia, 5 in Australia, and 1 in Canada). Of the 106 participants randomized, 101 participants received treatment.|The study consisted of 6, sequential, ascending-dose cohorts. Participants were randomized to either DS-1040b or placebo in a 3:1 ratio.
720009|NCT02586077||
720010|NCT02586025||
720011|NCT02586012||
720012|NCT02585999||30 participants completed the baseline questionnaire, but 2 withdrew prior to starting the study.
720013|NCT02585960|The study was conducted at 62 study centers in 19 countries between 23 November 2015 (first participant first visit) and 05 August 2018 (last participant last visit).|A total of 135 participants were enrolled in the study. Of them,14 participants were dropped out and did not receive any treatment 121 participants underwent initial pharmacokinetic(PK) assessment with a single administration of BAX 855 and based on their individual PK values, 115 participants were randomized to any one of the prophylactic regimen.
720014|NCT02585934||2173 participants signed consent and were screened for participation. Of these, 1470 entered a 3-week single-blind placebo run-in period with treatment with placebo qd + stable dose of donepezil 5 or 10 mg qd. There was an overlap between the participants from the run-in period and the participants that were randomized during the treatment period.
720015|NCT02585895|This study was conducted at 15 centers in the following 8 countries: Australia, Czech Republic, France, Germany, Italy, Spain, the United Kingdom, and the United States. Participants were enrolled from 21 December 2015 to 21 July 2016.|Participants were randomized in a 1:1 ratio to continue apheresis on the same schedule as before study entry, or to stop apheresis and receive evolocumab. Randomization was stratified by screening low-density lipoprotein cholesterol (LDL-C) (< 160 mg/dL [4.1 mmol/L] vs ≥ 160 mg/dL).
720016|NCT02585843||
720017|NCT02585830||
720057|NCT02581995|Study was conducted at multiple study centers in 14 countries, between 19 November 2015 (first participant first visit) and 09 August 2017 (last participant last visit).|Overall, 676 participants were screened. Of them, 116 participants did not complete screening: 100 failed screening; 8 withdrew, 1 had an adverse event, 1 was lost to follow-up and 6 were not assigned to treatment for other reasons. A total of 560 participants were assigned to treatment and 31 participants discontinued the study prematurely.
720289|NCT02560779||
720018|NCT02585778|The study was conducted at 103 sites in 10 countries. Of these, 97 active sites randomized at least 1 participant. Overall 796 participants were screened between October 2015 and August 2016, of whom 279 were screen failures. Screen failures were mainly due to exclusion criteria met or inclusion criteria not met.|Randomization was stratified by diabetes type (Type 1 diabetes mellitus [T1DM] versus Type 2 diabetes mellitus [T2DM]). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 2:1 ratio (Alirocumab:Placebo). A total of 517 participants were randomized. Baseline and efficacy data were analyzed per stratum.
720019|NCT02585713||
720020|NCT02585700|All volunteers were recruited at the Clinical Center of Serbia, Belgrade, Serbia.|66 people were screened for the study after signing consent. 6 subjects failed screening. A total of 60 subjects received vaccine or placebo.
720021|NCT02585245||
720022|NCT02584998||
720023|NCT02584959|This was a multicenter study conducted at 33 sites/centers in 7 countries: United States, Canada , Germany, Hungary, Israel, Spain, and Romania .|Of the 81 participants screened, 6 subjects failed to meet the randomization criteria and were not randomly assigned to a treatment sequence . All 75 randomly assigned participants received at least 1 dose of the IP.
720024|NCT02584868||
720025|NCT02584855|This study had four periods: Period 1: Screening period lasting from 4 to 30 days before Week 0, Period 2: Initial open-label treatment period from Week 0 up to Week 36, Period 3: randomized double-blind withdrawal period from Week 36 to week 104 (or, early termination or relapse) and Period 4: post treatment follow-up.|Participants were randomized during week 36 to week 64. The criteria for randomization in period 3 was having received ixekizumab (IXE) 80 mg Q2W for at least 6 months and meeting Coates criteria for minimal disease activity (MDA) for 3 consecutive months over 4 consecutive visits.The criteria was met anytime from 36 to 64 weeks.
720026|NCT02584790||
720027|NCT02584725||
720028|NCT02584686|Started Nov 1, 2015 Completed May 24, 2016 Cairo University Andrology outpatient clinic|
720029|NCT02584673||
720030|NCT02584660||Of the 300 participants screened, 114 participants were randomized (51 to rivaroxaban group and 63 participants in the standard-of-care group) and 112 participants were treated and received at least 1 dose of study agent.
720031|NCT02584504|The study was conducted at 30 active centers in Japan. Overall 241 participants were screened between 30 November 2015 and 19 October 2016, of whom 78 were screen failures and 163 were randomized. Screen failures were mainly due to exclusion criteria met.|"Randomization stratified per background statin therapy (Yes/No). No statin also stratified per background fibrate/ezetimibe therapy (Yes/No), 'Yes' =fibrate/ezetimibe, 'No' =diet therapy alone. Randomization followed 1:1:1 ratio (Alirocumab 150 mg Q4W: Alirocumab 150 mg Q2W: Placebo Q2W)."
720032|NCT02584452||Two participants consented but withdrew from the study prior to randomization.
720033|NCT02584257|Male/female patients 18-65 years of age, inclusive, with a diagnosis of asthma and at least a 6-month history of stable mild asthma as defined by the NAEPP EPR-3 guidelines were recruited and enrolled at 17 different centers in the USA. First subject was screened on April 12th, 2016 and the last patient was completed the study on August 12th, 2016.|Of the 217 patients enrolled in the study, 126 failed screening or were randomization failures, largely due to failure to meet the inclusion and exclusion criteria. 91 Subjects were randomized to treatment groups.
720034|NCT02584140||
720035|NCT02583477|This study consisted of 2 independent cohorts, each of which ran at separate times between 25 March 2016 and 09 July 2018. In Cohort 1, participants were recruited from 1 center in the United States; in Cohort 2, participants were recruited from 6 centers in the United Kingdom.|Participants underwent screening evaluations to determine eligibility within 4 weeks (28 days) prior to first administration of the Investigational Product (IP). A total of 27 participants (3 in Cohort 1 and 24 in Cohort 2) were assigned to treatment and 23 were treated. Only treated participants are included in the participant flow.
720036|NCT02583425||
720037|NCT02583399|Enrollment occurred between 08-Aug2017 and 21-Feb2019. Subject were recruited were hospitalized pediatric subjects, aged birth (greater than 37 weeks gestational age) to less than six months of age, with a clinical indication of pain and fever.|
720038|NCT02583360||
720039|NCT02583269||
720040|NCT02583256|This study was conducted at 17 sites in total; 9 sites in Finland, 4 sites in the Philippines and 4 sites in Thailand.|All enrolled subjects were included in the study.
720041|NCT02583230||
720042|NCT02583048|Participants were enrolled from August 2016 to July 2018 at 3 non-US clinical research sites.|Participants were randomized with equal probability to each of the 3 experimental arms.
720043|NCT02582983||
720044|NCT02582970||
720045|NCT02582840|26 October 2015 to 04 June 2016, Japan, patients with type 1 diabetes mellitus.|Of 62 patients who signed informed consent, 42 eligible patients randomized and completed the 7-day treatment period (Part A) of the study.
720046|NCT02582814||
720047|NCT02582749||
720048|NCT02582684||A total of 122 participants were accrued.
720049|NCT02582671||Safety population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known.
720050|NCT02582658||A total of 173 patients were enrolled in the study; 2 patients never started treatment and were excluded from the safety (SP; N=171); 6 patients were excluded from the core population (CP; N=165), defined as all SP patients who met eligibility criteria and were adequately treated according to the standard of care and local label recommendations.
720051|NCT02582632||
720052|NCT02582515||
720053|NCT02582255||
720054|NCT02582242|A total of 50 sites were approved for recruiting subjects, of which 48 sites (in 2 regions) screened and randomized the subjects (China region, including mainland China, Hong Kong and Taiwan; non-China region, including other 4 countries) as follows: Algeria: 3; mainland China: 23; Hong Kong: 1; India: 8; Taiwan: 4; Turkey: 5; Ukraine: 4.|
720055|NCT02582216||
720056|NCT02582151||
720058|NCT02581930|Dates of the recruitment period were 12/12/16-12/14/17 in medical clinic.|
720120|NCT02577003||Prior to randomization, all participants received placebo for 2 weeks.
720290|NCT02560753||
727229|NCT01985685||
720060|NCT02581865|This study enrolled participants (male and female) with a diagnosis of Tourette Syndrome through Diagnostic and Statistical Manual of Mental Disorders, 4th or 5th Editions (DSM-IV or -V) from approximately 40 study centers in the United States|
720061|NCT02581839||
720062|NCT02581488||
720063|NCT02581475||
720064|NCT02581410||
720065|NCT02581345|A total of 572 participants were enrolled and randomized equally into M923 and European Union reference protein product (EU RPP) arms. One participant in each arm did not receive any treatment. The 263 participants completing EU RPP treatment in Part 1 were randomized to 1 of 2 treatment arms in Part 2 (Transition and Continuous).|
720066|NCT02581202||
720067|NCT02581189||Safety population: all enrolled participants receiving at least 1 dose of the ABBVIE REGIMEN.The prescribed ABBVIE REGIMEN needed to be known. 565 participants enrolled; treatment not started in 28 participants; 3 withdrew consent and no start of treatment was recorded; Two of the 3 deaths noted below occurred during the SAE collection period.
720068|NCT02581163||Safety population: all enrolled participants receiving at least 1 dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known. 314 participants enrolled; treatment start date was missing in 2 participants; 1 withdrew consent and no start of treatment was recorded.
720069|NCT02581137||
720070|NCT02581111||
720071|NCT02580877||
720072|NCT02580799||A total of 5 trial sites (named as Sites A to E) along with 1 reference site (named as Abroad) participated in this study.
720073|NCT02580591|A randomized, placebo-controlled, double-blind, parallel-group study compared 3 doses of empagliflozin (2.5 milligram (mg), 10 mg, and 25 mg) with placebo in patients with type 1 diabetes mellitus (T1DM) as adjunctive to optimized insulin therapy.|6-Week T1DM therapy (insulin) optimisation period followed by a 2-Week placebo run-in period before randomization. Patients who successfully completed both of the periods were randomized into the 26-Week double-blind treatment period. All treatments were administered in addition to optimized insulin therapy.
720074|NCT02580357|At clinical site|
720075|NCT02580318||54 participants.
720076|NCT02580240||
720077|NCT02580201||
720078|NCT02580188||
720079|NCT02580058||
720080|NCT02579928|Adolescents (aged 13 to 17 years old) were recruited via (1) physician referral or (2) via direct inquiries from families via ClinicalTrials.gov listing. Subjects were enrolled at the Yale Child Study Center (New Haven, CT) between May 2016 and September 2018.|Participants were to remain on stable dosing of their current medication regimen for the four weeks prior to the first infusion, and during the four-week trial itself. All participants underwent a physical examination, laboratory screening, and electrocardiography.
720081|NCT02579915||
720082|NCT02579876||
720083|NCT02579863||
720084|NCT02579811||
720085|NCT02579772||
720086|NCT02579759||
720087|NCT02579629|Participants were enrolled between July 2015 and July 2019.|
720088|NCT02579616|Participants took part in the study at 7 investigative sites in Japan from 23 Oct 2015 to 27 Feb 2019.|A total of 29 participants were screened and enrolled, of which 3 were screen failures and 26 were treated in the study.
720089|NCT02579603||
720090|NCT02579421||
720091|NCT02579382|Participants were enrolled at study sites in Asia, Europe, New Zealand, and North America. The first participant was screened on 10 November 2015. The last study visit occurred on 03 May 2019.|260 participants were screened
720092|NCT02579135||
720093|NCT02579057||
720094|NCT02578992|Patients aged 20-80 years who were scheduled for various surgeries requiring general anesthesia with tracheal intubation were recruited. All patients exhibited an American Society of Anesthesiologists physical status of I-III. From November 2014 to October 2015|Patient denied to participated, equipment unavailable or malfunction, difficult mask ventilation were excluded .
720095|NCT02578940|This study was conducted between 27 November 2015 (first patient, screening visit) and 22 June 2018 (last patient, completed) at seven sites (one did not enrol) in the UK.|
720096|NCT02578862||
720097|NCT02578745|We recruited 120 patients from October 2015 to April 2016 at Washington University Medical Center|We enrolled patients undergoing scheduled or emergency cesarean delivery.
720098|NCT02578706||
720099|NCT02578680||These interim results are based on a database cutoff date of 08-Nov-2017, at which time 372 participants were ongoing in the study. 67 participants randomized to receiving Control treatment had switched to receiving pembrolizumab monotherapy treatment. These interim results are for randomized treatment only.
720100|NCT02578316||
720101|NCT02578238||Case report forms were retrieved from 152 participants during the study period. Among these participants, 143 were included in the safety analysis population, excluding 9 participants who did not use the drug according to the approved indication or dosage.
720102|NCT02578199||
720103|NCT02578186|Participants were recruited at Henry Ford Medical Hospital, Detroit MI, USA between October 2013 to December 2014.|43 subjects screened. 33 subjects received product (ie, enrolled, for the purposes of this reporting), of whom 2 withdrew but re-enrolled (per protocol amendment). These 2 subjects are counted as starting each sequence in the table below, bringing total started to 35 and for AEs to 30 and 29 (DPH and placebo, respectively.) 25 subjects completed.
720104|NCT02577991||
720105|NCT02577978||
720106|NCT02577900||
720107|NCT02577887||
720108|NCT02577822||
720109|NCT02577718||
720110|NCT02577601||
720111|NCT02577510||We enrolled 21 participants and randomized the sides for each modality.
720112|NCT02577445||
720113|NCT02577354||
720114|NCT02577315|Actual number of subjects enrolled in fact represents entered / randomized subjects due to the study set up.|
720115|NCT02577146||
720116|NCT02577107||
720117|NCT02577042||
720118|NCT02577029||
720119|NCT02577016||Prior to randomization, all participants received placebo for 2 weeks.
720326|NCT02556632||
720121|NCT02576990|This study was conducted at 25 clinical centers in 13 countries.|A screening period occurred 28 days prior to the treatment period. The treatment period consisted of a 28-day treatment cycle for up to 35 administrations of study medication (approximately 2 years). There was a post-treatment safety follow-up 30 days post the last dose of treatment. Survival was followed up every 12 weeks.
720122|NCT02576977|Subject Disposition as per database cutoff date of July 9, 2018.|
720123|NCT02576951||
720124|NCT02576938||
720125|NCT02576899||
720126|NCT02576678|The study was conducted at 11 study centers in 4 countries, including the United States, Canada, Germany and Spain.|Participants were enrolled according to a staggered, stepwise approach by age range and weight starting with older and heavier participants. Dosing within and between groups was staggered based on PK data collected and a minimum of 2 weeks of safety data.
720127|NCT02576652|This study was conducted at one center in the United States.|
720128|NCT02576639||Participants were randomized in a 1:1:1:1:1 ratio to 5 treatment groups: placebo, CNP520 2 mg, CNP520 10 mg, CNP520 35 mg and CNP520 85 mg.
720129|NCT02576587||
720130|NCT02576535||
720131|NCT02576509||743 participants were assigned to treatment, and 730 treated. Reasons for 13 not treated: 2 requests to stop treatment; 6 withdrew consent; 5 no longer met study criteria
720132|NCT02576249||
720133|NCT02576145||
720134|NCT02576067|Participants enrolled period from Dec 2015 to April 2018|
720135|NCT02576054||
720136|NCT02576041||Screening was performed in 2 separate sections, at hospital site (H) and at the simulator (S) center. A total of 19 patients were screened and only one discontinued study before starting placebo treatment due to agitation, sickness, transpiration and vomiting at the simulator driving test.
720137|NCT02575950||19 of the participants enrolled were screening failures. The remaining 40 were enrolled sequentially into 4 cohorts. Progression from one cohort to the next was decided by the Safety Review Committee following a review of local skin responses (LSRs), safety, and tolerability after the last participant in each cohort had completed the Week 2 visit.
720138|NCT02575911|Participants were recruited from 2 sites located in the US.|Of the 34 enrolled, 4 participants were exited as screen failures prior to surgery. This reporting group includes all treated participants (30).
720139|NCT02575833|This study was conducted at 35 centers across the United States, South Africa, New Zealand, and the European Union (EU). Participants were enrolled from November 2015 to January 2017.|Participants were randomized in a 1:1 ratio to receive either a single dose of erenumab 140 mg or placebo intravenously (IV) prior to starting an exercise treadmill test. Randomization was stratified by the total exercise time average (< 7 minutes or ≥ 7 minutes) of the 2 qualifying exercise treadmill tests performed during screening.
720140|NCT02575807||
720141|NCT02575365|It was planned to recruit 80 patients. By the end of the first year, 4 patients have been recruited and the study was stopped due to low enrollment and study results were analyzed.|
720142|NCT02575300||
720143|NCT02575079|Participants were enrolled in the parafilm study between March 2015 and June 2017. All study procedures and follow up was completed on March 29, 2018.|Fifty-one individuals consented to participate in the study. Prior to beginning any study interventions one was lost to follow up, one withdrew, and one did not begin the prep regimen, resulting in 48 participants who began the study intervention.
720144|NCT02574858||
720145|NCT02574845|All subjects were screened for eligibility to participate in the study. No run-in or wash-out period was conducted, since the trial was conducted in healthy subjects, that were not expected to take medications regularly. Actual number of subjects enrolled in fact represents randomized subjects due to the study set up.|All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subjects) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
720146|NCT02574832||
720147|NCT02574637||The study enrolled 29 participants who were randomized to one of five treatment groups (Placebo/ Brazikumab High dose/ Brazikumab High-Medium dose/ Brazikumab Low dose/ Brazikumab Low-Medium dose). This study was terminated early.
720148|NCT02574598||
720149|NCT02574481||A total of 524 subjects have been enrolled in the IMPERIAL trial, including 465 subjects in the RCT, 50 subjects in the LL substudy and 13 subjects in the PK substudy. There were 4 subjects enrolled in both the PK and Long Lesion substudy.
720150|NCT02574312|The first patient was operated on 16 November 2015 and recruitment lasted for 37 months with the last patient operated on 19 December 2018.|Consent was taken for 102 knees, 14 subjects were deemed ineligible for the study. This left 88 subjects in the safety population that could be randomised for the study.
720151|NCT02574260||
720152|NCT02574247||Participants were randomly assigned to Training and Control groups a priori.
720153|NCT02573948|People Who Injected Drugs (PWID), age > 18 years, with history of injecting drug use confirmed by a positive urine test and visual inspection of injection marks|
720154|NCT02573870|This study consisted of 1-week run-in period, 6-week (42-day) treatment period and 1-week follow-up period. Eligible participants (par.) were randomized (2:1) to either batefenterol (BAT)/fluticasone furoate (FF) 300/100 micrograms (µg) or a placebo in double blinded treatment.|A total of 62 participants withn an established clinical history of chronic obstructive pulmonary disease (COPD) were randomized and received at least one dose of study drug (forming the Intent-to-Treat Population), out of which 7 participants were withdrawn from the study.
720155|NCT02573857||After reviewing the safety data obtained from the first 2 cohorts, the SRT decided not to enrol Cohort 3.
720156|NCT02573779|Eligible study participants included premature inborn infants at <1500 g BW with no barriers to enteral milk feeding. Infants were approached and enrolled within the first 72 hr of life.|Of 223 inborn infants <1500 g BW between September 2015 to August 2016, 33 infants were excluded, 59 could not be enrolled within 72 h, and 6 were not enrolled because their parents declined. Of the 125 enrolled infants, 8 were removed from the study owing to GI defects or complications unknown at time of enrollment that precluded enteral feeding.
720521|NCT02539563||
720522|NCT02539511||50 participants were enrolled in the study and from those, 40 were randomized.
720157|NCT02573467|Participants entered extension study treatment period after completing the core study and continued on the study drug to which they were randomized in the core study (one of 3 bimagrumab doses (1mg/kg, 3mg/kg or 10mg/kg) or placebo). Participants discontinued from the treatment period were to enter a 6-month, treatment-free Follow-up Period (FUP).|All participants (N=211) were discontinued from the double-blind treatment period, 178 of whom entered the FUP. Overall 154 participants completed the FUP and 20 discontinued due to subject/guardian decision and 1 for technical reasons. Three discontinued FUP due to death (one each in the 10mg/kg, 3mg/kg, and placebo groups).
720158|NCT02573402||
720159|NCT02573311||The trial consisted of 2 parts. One was the product review phase (Part 1) and another was the actual use phase (Part 2). The number of enrolled patients in the protocol represent the number of participants (1117) who intended to purchase study product and enter part 2 of the study. All endpoints are based on part 2 of the study.
720160|NCT02573233|The study was conducted at 16 sites in 6 countries. A total of 133 participants were screened between January 2016 and January 2018. Of which, 42 participants were randomized. 91 participants were screen failures mainly due to exclusion criteria met and inclusion criteria not met.|Participants were randomized in 1:1 ratio to receive dupilumab 300 mg every 2 weeks (q2w) and placebo q2w by using Interactive Voice/Web Response System (IVRS). Randomization was stratified by inhaled corticosteroids (ICS) dose (medium and high) and region (North America and Europe).
720161|NCT02573181|Participants were recruited at 17 study centers in the United States.|
720162|NCT02573155|This study was conducted at 2 centres in the UK (one for each part). In part 1 of the study, the first patient was screened in October 2015 and the last patient visit was in March 2016. In part 2 of the study, the first patient was screened in April 2016 and the last patient visit was in August 2016.|"2-part study: Part 1: single ascending doses of AZD8871 (planned 50, 100, 300, 600, 1200, 1800 μg; actual dose 50, 200, 400, 900, 1800, 2100 μg) or placebo over 3 treatment periods; 2 cohorts (male; mild persistent asthma).
~Part 2: 5-way complete cross-over, single-dose; M/F, moderate/severe COPD; 2 doses of AZD8871, placebo, or 2 active controls."
720163|NCT02573012||314 participants were enrolled in the study; 55 participants discontinued the study prior to randomization; 259 participants were randomized.
720164|NCT02572817||
720165|NCT02572752||The trial was randomised and open-label with a 3-way crossover design (2 administrations of reference treatment and 1 administration of test treatment in all subjects). In this study 70 subjects were entered and treated.
720166|NCT02572609||The crossover design 2x2 was used in the study. This is a conventional nonreplicated design with two formulations, two periods, two sequences (RT and TR) where each individual is randomly allocated in one of these sequences.
720167|NCT02572570||
720168|NCT02572427||
720169|NCT02572401||
720170|NCT02572388||
720171|NCT02572167||
720172|NCT02572076|"all patients recruited between Feb 2016 to Dec 2016 at Emek Medical Center, Afula Israel."|
720173|NCT02571972||
720174|NCT02571777|Participants took part in 415 investigative sites in 41 countries|4851 participants were screened of which 3092 participants were randomized to 1 of the 5 treatment groups with a randomization ratio of 1:1:1:1:1.
720175|NCT02571634|23 subjects were enrolled between July 20, 2015 and Dec 22, 2015. They were recruited from Womack Army Medical Center's Interdisciplinary Pain Management Center. All were scheduled for a radiofrequency ablation of the lumbar facet joints. All were consented prior to any assessment or treatment.|
720176|NCT02571452|Participants were recruited from 1/6/16 to 8/9/18 through local advertisements, referrals from other research studies or VA clinicians and direct mailings to veterans that had established care at the San Francisco VA (SFVA) or that lived within a 40-mile radius of the SFVA.|A total of 157 people provided consent for screening, 119 completed screening and 93 were eligible, enrolled and randomized to treatment. Of the 93, two were withdrawn during treatment or 6-month follow-up due to no longer meeting eligibility and two were pilot subjects that didn't meet inclusion criteria and weren't included in data analysis.
720177|NCT02571439||Due to recruitment proceeding slower than expected and study personnel relocating from the study site, we closed the study before recruitment of planned number of subjects
720178|NCT02571244||
720179|NCT02571218||
720180|NCT02571153||
720181|NCT02571075||
720182|NCT02571049||
720183|NCT02570750||
720184|NCT02570711||
720185|NCT02570425||Participants were re-randomised to either the BF Spiromax first or Symbicort Turbohaler first at each visit.
720186|NCT02570295||
720187|NCT02570165|Eligible participants (par.) with an established clinical history of Chronic Obstructive Pulmonary Disease (COPD), were included in this dose-finding study of batefenterol (BAT). Of 585 par. screened, 324 par. were randomized in the study, out of which one par. was randomized in error and was not included in the Intent-to-Treat analysis.|Pre-bronchodilator and post albuterol/salbutamol spirometry testing were performed at Screening visit. Post-albuterol/salbutamol (Forced expiratory Volume in One Second) FEV1 and FEV1/ (Forced Vital Capacity) FVC values were used to determine subject eligibility. Participants underwent 2 weeks run-in period.
720188|NCT02570152||
720189|NCT02570139||
720190|NCT02570126||Five vaccinated subjects for whom the data could not be used due to invalid informed consent were excluded.
720191|NCT02570074||
720192|NCT02570022||
720193|NCT02569996|This study was conducted between 08 July 2005 to 12 Aug 2013 at 15 sites in Hungary.|A total number of 124 patients were recruited. Of these, 83 patients completed the maintenance therapy with rituximab (MabThera) and entered the 3-year follow-up phase. Of these, 69 patients completed the follow-up phase.
720194|NCT02569957||
720195|NCT02569853||
720196|NCT02569710|No participants were recruited for Cohorts 10 and 12, hence no data is reported here for these two cohorts.|
720197|NCT02569658||
720198|NCT02569541||
720199|NCT02569437|Subjects were recruited from September 2014 to April 2016 at the Mount Sinai Department of Otolaryngology-Head & Neck Surgery rhinology practice.|
720693|NCT02522884||
720694|NCT02522845|The trial period ran from May 2015 to December 2018|Patients not meeting inclusion criteria
720201|NCT02569398||Total of 557 participants were enrolled in study. Study was early terminated based on experience of significant elevations in liver enzymes in participants receiving JNJ-54861911 in this study and 54861911ALZ2004 (NCT02406027).
720202|NCT02569112|Ten subjects between the ages of 21 and 50 years of age, requesting a reduction in focal fat of the flanks were recruited from a single outpatient clinic.|Subjects received one session of cryolipolysis treatment on both sides of their body before one side of their body was treated with multipolar radiofrequency plus varipulse technology. Each subject acted as their own control.
720203|NCT02569086||
720204|NCT02568852||
720205|NCT02568683|Participants were enrolled at study sites in the United States and France. The first participant was screened on 11 February 2016. The last study visit occurred on 22 June 2017.|13 participants were screened.
720206|NCT02568644||
720207|NCT02568475||
720208|NCT02568397||
720209|NCT02568384||
720210|NCT02568345||
720211|NCT02568254||A total of 78 subjects were enrolled in this study. Of the enrolled subjects 74 subjects were dispensed at least 1 study lens and 4 subjects did not meet the eligbility criteria. Of the dispensed subjects 72 completed the study and 2 subjects were discontinued.
720212|NCT02568046|The first patient was enrolled in March 2016. In January 2017, the trial was terminated early and enrollment was prematurely discontinued.|
720213|NCT02568007||
720214|NCT02567968||
720215|NCT02567708|Eligible participants entered the 2 week Run-in phase and participants who met the randomization eligibility criteria entered into the 4 week Double-blind treatment period (DBTP) 1 followed by a 4-week wash-out period, 4 weeks DBTP 2 and a 2 week follow-up phase. The total duration of participation in the study was 16 weeks.|A total of 108 participants with persistent uncontrolled asthma, currently not treated with an inhaled corticosteroid (ICS) or long acting beta2 agonist (LABA) were screened, of these, 58 were screen failures and 50 entered the Run-in phase. All 50 par. were randomized into the study and received study treatments.
720216|NCT02567656||
720217|NCT02567552||
720218|NCT02567188||
720219|NCT02566889||Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab.
720220|NCT02566785|November 2015 through June 2016 at the Heart Failure Improvement Program of a regional hospital.|
720221|NCT02566759|Participants took part in the study at 1 investigative site in the United Kingdom from 23 September 2015 to 12 July 2016.|Healthy participants were enrolled in 4 part study to receive TAK-831: single rising dose (SRD) in Part 1; SRD/multiple rising dose (MRD) in Part 2; MRD in Part 3; relative bioavailability(rBA) in 3-sequence crossover in Part 4. Part 3 was terminated due to discomfort observed in participants from the cerebrospinal fluid (CSF) collection procedure.
720222|NCT02566590||
720223|NCT02566577||
720224|NCT02566369||
720225|NCT02566317||
720226|NCT02566265||
720227|NCT02566135||
720228|NCT02566109||
720229|NCT02566083||
720230|NCT02566044||The study was terminated after completion of all randomized patients in Cohort 2 due to strategic issues. All patients completed the study prior to termination.
720231|NCT02566031||
720232|NCT02566005|During the study period from September 2015-July 2016, 4767 patients delivered at Mount Sinai West and of these, 1423 deliveries followed induction of labor. A total of 200 patients consented to participate in the study and were randomized, 100 to each group.|
720233|NCT02565914|This study consists of 3 parts: Part A, B and C. Part A has completed while Parts B and C are ongoing. Primary Completion was achieved based on Part A in May 2019. Only Part A results are reported. Complete results for Parts B and C will be updated within 1 year of study completion date.|Participants from Parent Studies 103 (NCT02070744), 106 (NCT02347657), 107 (NCT02516410), 108 (NCT02392234), 109 (NCT02412111) and 111 (NCT02508207) were enrolled in this study. A total of 1044 participants were randomized in this study.
720234|NCT02565810||
720235|NCT02565784||
720236|NCT02565706||
720237|NCT02565628||A total of 20 participants were randomized, 19 participants were treated. One participant was randomized but withdrew consent before receiving any treatment. This subject was not included in any analysis set.
720238|NCT02565615||
720239|NCT02565576|A total of 44 patients were randomized to receive either IV CFZ533 or IV placebo, of which 34 patients (77%) completed the study.|Safety analysis set, and Full analysis: 44 patients (22 treated with CFZ533 and 22 with placebo) PK analysis set : 20 patients treated with CFZ533 PD analysis set: 42 patients (20 treated with CFZ533 and 20 with placebo)
720240|NCT02565485||
720241|NCT02565381||Some participants (N=8) enrolled in the study but did not return for randomization.
720242|NCT02565186||
720243|NCT02565147||Enrolled participants who underwent successful primary percutaneous coronary intervention (PPCI) defined as thrombolysis in myocardial infarction (TIMI) Flow of 2 or 3, underwent cardiac magnetic resonance imaging (CMR) at 5 days, and were without major protocol deviations were included in the per-protocol population (primary/secondary analyses).
720244|NCT02565108||
720245|NCT02564952|All participants were enrolled by invitation into the open-label extension (OLE) phase after completing the double-blind phase of the study.|Two of the 18 participants withdrew during the OLE titration period: 1 met protocol-specified withdrawal criteria; 1 had GWP42003-P withdrawn due to adverse events (AEs) ongoing at entry to the OLE phase.
720246|NCT02564926|First patient enrolled: 05 January 2016 Last patient last visit: 15 January 2018|178 patients provided informed consent. 121 patients received study treatment and were included in the SAF population. 112 patients received study treatment and had at least one post-baseline primary efficacy assessment and were included in the FAS population (56 patients in each treatment group).
720247|NCT02564887||
720248|NCT02564718|Study was conducted at 9 study centers in 7 countries between 19 November 2015 (first participant first visit) and 18 December 2017 (last participant last visit).|Overall, 11 participants were screened, of these 1 participant was not included in the study due to withdrawal by parent. A total of 10 participants were assigned to treatment.
720695|NCT02522728||
720249|NCT02564497||491 participants were enrolled; 146 were randomized and treated. 232 participants were enrolled but not randomized because they no longer met study criteria, 1 participant withdrew consent and 112 participants were not randomized for other reasons.
720250|NCT02564432|Patients, who were recruited to participate in the early feasibility study of the percutaneous osseointegrated prosthesis (NCT02720159), were also recruited to participate in this study. Patients were transfemoral amputees selected from the VA patient registry|
720251|NCT02564354|Subjects were screened and enrolled at 5 hospitals in the USA and Europe. Screenings for Cohort 1 and Cohort 2 occurred in parallel between between 19th October 2015 and 14th July 2016.|
720252|NCT02564263||This results disclosure is based on a data cutoff date of 15-Oct-2018, at which time 67 participants were ongoing in the study.
720253|NCT02564211||
720254|NCT02564120||
720255|NCT02564055|Eligible participants entered a 4 weeks screening phase and participants who met the eligibility criteria entered into the 12 weeks double-blind treatment phase and 4 weeks post-treatment follow-up phase. The total duration of participation in the study was 16 to 20 weeks.|A total of 363 adolescent and adult participants with atopic dermatitis (AD) were screened, of which 116 were screen failures and 247 entered the treatment phase. Participants in the treatment phase were randomized to receive GSK2894512 cream (0.5 or 1%) or vehicle control once daily (QD) or twice daily (BID).
720256|NCT02564042|This was a randomized, double-blind, dose-finding study of GSK2894512 in adult participants with psoriasis. The study consisted of 3 periods: 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of study for a participant was 16-20 weeks.|A total of 290 participants were screened of which 63 failed screening and 227 participants were randomized into the study. Participants in the treatment phase were randomized to receive GSK2894512 cream (0.5 or 1 percent) or vehicle control once daily (QD) or twice daily (BID).
720257|NCT02564029||
720258|NCT02564016||
720259|NCT02563990||
720260|NCT02563899|The study conducted between 23 November 2015 to 25 February 2016. The data for population pharmacokinetic (PK) analysis was pooled from the earlier two studies including LHH117157 (NCT01934153) (6 participants from Cohort B) and AC4112008 (NCT01110018) (9 participants) with the data of the current study.|A total of 28 participants randomized in this study. Because of a system configuration error, randomization numbers were assigned to 5 screen failure participants. However, these participants did not enter the study and not dosed, remaining 23 participants (18- Umeclidinium; 5- Placebo) included in Full Analysis Population.
720261|NCT02563860||
720262|NCT02563834||
720263|NCT02563808||
720264|NCT02563548|The study was conducted in 2 parts: dose escalation and dose expansion. A total of 56 participants were enrolled (35 with gastric adenocarcinoma [GAC] and 21 with non-small cell lung cancer [NSCLC]).|14 participants (10 with GAC and 4 with NSCLC) were enrolled in dose escalation part. Due to evolving standard-of-care in the immuno-oncology treatment landscape, this study discontinued further enrollment on 31 May 2018. At the time of the early termination, 42 participants (25 with GAC and 17 with NSCLC) had been enrolled in dose expansion part.
720265|NCT02563496|This was an open label, Phase 2, multicenter study to assess the pharmacokinetics, safety and efficacy of tafenoquine in participants with Plasmodium Vivax Malaria.|A total of 66 participants were screened, of which 6 participants failed screening. Hence, 60 participants were enrolled in this study. The cohort Tafenoquine 50mg was initiated, but study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort. Hence, no participants were enrolled in this cohort.
720266|NCT02563106||
720267|NCT02563093|Study participants were enrolled from 28 September 2015 to 03 November 2015 at 4 clinic centers in the United States.|A total of 208 participants who met all of the inclusion criteria and no exclusion criteria were enrolled and vaccinated.
720268|NCT02563028||
720269|NCT02562989||
720270|NCT02562924||All subjects were enrolled prior to surgery (day 0). Days 0-7 all subjects were treated with oral prednisone once daily, nasal saline irrigation four times daily, and nasal saline misting hourly while awake. Assignment to each arm occurred on day 7. Three enrolled subjects withdrew prior to assignment because they elected to not undergo surgery.
720271|NCT02562898||
720272|NCT02562755||
720273|NCT02562521||
720274|NCT02562482||
720275|NCT02561897|"Recruitment period 2015-2017
~Recruited in hospital and medical clinic"|
720276|NCT02561832|Patients were screened between 06 November 2015 and 02 June 2016 at 7 medical centers in 2 countries|At screening, consenting patients were assessed to ensure that they met eligibility criteria. Once eligibility criteria were confirmed, patients underwent assessments applicable for the visit. Procedures that were part of standard of care may have occurred before informed consent was obtained.
720277|NCT02561806|Induction period occurring from week 0 to week 12 followed by maintenance period occurring week 12 to week 52 followed by post-treatment follow-up period occurring from last treatment period visit (week 52) or Early termination visit, for a minimum of 12 weeks following that visit.|
720278|NCT02561702||
720279|NCT02561585|Date of First Subject First Visit: 02-Feb-2016 Date of Last Subject Last Visit: 06-Dec-2016|A total of 40 participants were screened, 9 participants were screening failures, and the remaining 31 participants were randomized as follows: 20 participants to LEO 124249 ointment 30 mg/g group and 11 participants to LEO 124249 ointment vehicle group.
720280|NCT02561572||
720281|NCT02561481||
720282|NCT02561338||
720283|NCT02561221|Eighteen primary care clinics were randomized equally to either the Intensive Lifestyle Intervention or Usual Care. Patients received the intervention to which their clinic was assigned. Study enrollment occurred from April 2016 to September 2017. Patients completed a pre-screener and attended a screening visit which included the consent process and measurement to determine height and weight for BMI among other eligibility criteria. Patients were enrolled upon baseline visit completion.|
720284|NCT02561195||
720285|NCT02561156|Participants took part in the study at 1 investigative site in United Kingdom from 26 August 2015 to 23 September 2017.|Healthy participants were enrolled in this 2 part study to receive TAK-653 as: single rising (SRD) dose of 0.3 milligram (mg), 1 mg, 3 mg , 5 mg, 9 mg or 18 mg in Part 1, and SRD/multiple rising dose (MRD) of 0.3 mg, 1 mg, 3 mg, 6 mg or 9 mg in Part 2.
720291|NCT02560701|Participants were identified in claims data. Each was required to have one inpatient episode or two outpatient visits with a corresponding diagnosis of bipolar disorder. Patients with schizophrenia or schizoaffective disorder were excluded.|Study participants without either a) two years of continuous enrollment in a low-deductible health plan OR b) one year of enrollment in a low-deductible plan followed by a continuous year of enrollment in a high-deductible plan were excluded. This brought the sample size from 350,823 to 97,302.
720292|NCT02560584||
720293|NCT02560558||
720294|NCT02560493||
720295|NCT02560389||103 participants enrolled but only 91 started in the study. 12 participants did not start in the study (6 did not show up, 3 were claustrophobic, 1 was too large to fit in MRI scanner and 2 were tested positive for having used cannabis)
720296|NCT02560324|697 potential participants were pre-screened over the phone for eligibility between September 2015 and August 2018. 140 potential participants attended an in-person eligibility screen at the research clinic.|69 of 140 participants met eligibility criteria and were randomized. For participants who were not randomized: 61 did not meet inclusion criteria, 5 declined to participate, 4 missed the baseline visit, and 1 is unknown.
720297|NCT02560051||
720298|NCT02560038||
720299|NCT02560025||
720300|NCT02560012||One enrolled patient's tumor did not have a genomic profile completed as next-generation sequencing was not done. Both proteomics and genomics assessments were required so patient was excluded.
720301|NCT02559895||A total of 2413 participants signed the ICF, of which 898 participants met the entry criteria and were randomized into the trial.
720302|NCT02559817||There was a screening period of 14 to 28 days, followed by a Pretreatment period of 14 to 21 days, prior to randomization of study participants.
720303|NCT02559713|Participants took part in the study at 4 investigative sites in the United States from 29 November 2017 to 22 February 2019.|Lactating women with a diagnosis of active ulcerative colitis (UC) or Crohn's disease (CD) being treated with vedolizumab were enrolled to receive a single vedolizumab 300 milligrams (mg) dose intravenous (IV).
720304|NCT02559687||Of 185 participants screened for inclusion, 121 were enrolled and received treatment.
720305|NCT02559622|The study was conducted at 23 centers in Germany.|
720306|NCT02559570||Pediatric participants aged 6 to 11 years were dosed using a weight-based approach. For participants who weighed <35 kg, the doses administered corresponded to about 0.25 to 0.5, 0.5 to 1, or 1 to 2 µg/kg. For participants who weighed ≥35 kg, the doses were not to exceed 0.5, 1, or 2 µg/kg.
720307|NCT02559414||
720308|NCT02559310|The study was designed to enroll adults with CABP that was severe enough to require a minimum of at least 3 days of IV treatment. Subjects with a PORT score of III, IV and V were eligible. The first subject was randomized in February 2016 and the last subject was randomized in April 2017.|Subjects who met inclusion criteria and did not meet exclusion criteria were randomly assigned to a treatment group. Administration of study drug was expected to occur as soon as possible after the diagnosis of CABP with all Screening/Baseline assessments expected to be completed within 24 hours before the first dose IV study drug.
720309|NCT02559206||A total of 227 of the 759 participants who signed an informed consent form and entered the Pretreatment Period were not randomized into the study, and were identified as pretreatment failures.
720310|NCT02558894|"First patient enrolled: 16 Nov 2015; Part A data cut-off: 26 May 2017. The study contained a Part B which was not opened; only Part A was conducted.
~Study assessed efficacy of durvalumab (MEDI4736) + tremelimumab combination therapy compared to durvalumab (MEDI4736) monotherapy.
~Study performed at 21 sites in 6 countries."|65 patients were randomised to receive investigational product (IP) and 64 received treatment. One randomised patient in the durvalumab monotherapy arm was withdrawn prior to receiving any IP but was still included in the full analysis set (FAS) which was used for participant flow and baseline analysis.
720311|NCT02558829|"Study centers: 30 sites in 9 countries had been initiated,i.e. 25 sites in Europe (Austria, Germany, Spain, France, Italy, Poland, Serbia, and UK) with 21 of them becoming active, and 5 sites in the USA.
~Study period: first subject screened: 01-Oct-2015, first subject randomized (= enrolled): 03-Dec-2015, Last subject completed: 29-Nov-2016."|A subject registered in the eCRF as 'eligible' was assigned to the applicable Group A/B/C (= stratum). The sequence for performance of both growth hormone stimulation tests (GHSTs) in Group A/B/C subjects was assigned by stratified randomization. Healthy control subjects (Group D) were tested in the same sequence as the matched Group A subjects.
720312|NCT02558790||
720313|NCT02558400||
720314|NCT02558374|Participants were recruited at 53 sites starting in September 2015|
720315|NCT02558231||
720316|NCT02557698|Recruitmant period: Nov 2014 - Apr 2015, Location: Charité University Hospital|
720317|NCT02557646|Out of 697 participants enrolled in the study, only 693 participants provided evaluable data. One participant did not receive peginterferon alfa-2a/ribavirin combination therapy, while 3 participants received combination therapy only for a very short time.|
720318|NCT02557555||
720319|NCT02557516|"It was anticipated that up to 24 patients (3 to 6 patients; 4 dose levels) would be enrolled in Phase 1 part of the study and up to 24 patients in the Phase 2 part with a total of up to 45 patients in the trial.
~A total of 22 patients were actually enrolled in the study: 13 patients in the Phase 1 part and 9 patients in the Phase 2 part."|The first part of the study had a 3+3 design. Four dose levels of monalizumab were planned: 1 mg/kg, 2 mg/kg, 4 mg/kg and 10 mg/kg. Dose-escalation decisions were made by a Safety Committee.The dose of monalizumab for all patients in phase 2 of the study (2 mg/kg) was also chosen by the Safety Committee based on phase 1 data.
720320|NCT02557399|DUAC® (clindamycin phosphate 1.2 percent [%] + benzoyl peroxide 3%) is the registered product of GlaxoSmithKline. This study was conducted between 07 October 2015 and 17 February 2016 in which 349 participants were randomized.|
720321|NCT02557100||80 participants randomized and treated.
720322|NCT02557035||
720323|NCT02556918||One participant died during hospital admission before receiving study medication.
720324|NCT02556801|The total recruitment period of the study was from September until November 2015. As soon as approx. 160 subjects had been randomized, recruitment was stopped and the investigator was informed to end recruitment of patients. Already screened patients were randomized, if eligible. See summary in the table below.|
720325|NCT02556788||
720327|NCT02556554|From 08/2015 to 06/2016, investigators enrolled women in preconception and the 1st trimester at the Barbara Davis Center, and followers. Other women consented for the retrospective (no CGM) group. Follower data only included answers to monthly questionnaires. Study registration was delayed due to staffing issues and account set-up in the system.|Study cohorts: (1) women with T1D prospectively enrolled in 1st trimester or when planning pregnancy, (2) followers (family/friends) of women in the 1st cohort, and (3) women with T1D with a pregnancy within the past 3 years who did not use CGM therapy during gestation (retrospective). Follower data only included answers to monthly questionnaires.
720328|NCT02556333||
720329|NCT02556307||
720330|NCT02556255||
720331|NCT02556203|Study was conducted at 136 centers world-wide between 16 Dec 2015 (first patient's first visit) and 27 Nov 2018 (last patient's last visit).|A total of 1674 subjects were screened, of which 1644 were randomly assigned to either of the two treatment arms and 1608 subjects started treatment with study medication.
720332|NCT02556177||
720333|NCT02556138|All subjects were recruited at the Mayo Clinic in Rochester, Minnesota.|
720334|NCT02556112|Recruitment began August 2015 and ended April 2018. Participants were recruited through flyers table tents in the Medical Group clinics and cafeteria and email blasts through unit fitness monitors.|Once participants were enrolled to the study, initial measurements (with the exception of lab work requiring blood draws) were taken before assignment to groups. The reason for this was to avoid bias on the part of the research team that might occur with knowledge of group assignment before obtaining initial data.
720335|NCT02555878|A total of 841 participants were enrolled in the study to receive either of the 2 treatments: rivaroxaban or matching placebo.|Deaths which were primary cause of treatment discontinuation (up to Day 180) are reported in participant flow excluding deaths which occurred after discontinuation.
720336|NCT02555722|Subjects were randomized to the study lenses based on a 2 to 1 ratio within each investigational site and across the entire study using randomization tables.|Two (2) subjects were ineligible and were not randomized and exited the study. This left 90 subjects randomized into the test and control products.
720337|NCT02555683|Participants were from Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Latvia, Lithuania, Philippines, Poland, Romania, Singapore, Spain, Switzerland, UK, US, Vietnam.|The study included a Screening period of up to 2 weeks and a Placebo Run-in period of 2 to 6 weeks, during which eligibility for randomization was determined.
720338|NCT02555657||
720339|NCT02555631||
720340|NCT02555618|Participants took part in the study at 1 investigative site in Japan from 24 September 2015 to 18 November 2015.|Healthy Volunteers were enrolled equally in 1 of 2 groups, TAK-850 subcutaneous (SC) or Influenza hemagglutinin (HA) vaccine SC.
720341|NCT02555371|A multi-center, randomized, double-blind, placebo controlled, parallel group study to compare cessation versus continuation of long-term mepolizumab treatment. Participants (par.) who completed the Follow Up/Exit Visit or Early Withdrawal Visit from study MEA115666 (NCT01691859) or 201312 (NCT02135692) were eligible to participate in this study.|This is a 3 period study including variable open-label (OL) run-in, double-blind (DB) treatment period and open-label treatment switch period. The study was conducted in 75 centers across 14 countries from 07-Jan-2016 to 24-Jul-2019.
720342|NCT02555306||
720343|NCT02555228||
720344|NCT02555215||
720345|NCT02555098||
720346|NCT02554981||
720347|NCT02554929|This study was conducted at the Hospital for Sick Children (SickKids). Children, aged 4-7 years, were screened to participate in the treatment study by one of the principal investigators (child psychiatrists) at an anxiety disorders clinic in SickKids.|Of the n=93 consented participants, 3 withdrew consent prior to randomization and treatment assignment.
720348|NCT02554890|A total of 964 patients were screened for the study. Of these, 887 patients were randomized, 444 to enalapril and 443 to sacubitril/valsartan, and 875 randomized patients were treated.|Patients were randomized 1:1 to sacubitril/valsartan or enalapril. At the end of the 8-week treatment period, all patients had a 36-hour washout from study treatment prior to starting the open-label extension to ensure that the blinding of the core study was maintained.
720349|NCT02554877||
720350|NCT02554799|"Optional Cohort:
~The study design of this clinical trial allowed for an optional cohort to be enrolled. Ultimately, such optional cohort was not deemed required and therefore not conducted."|
720351|NCT02554786|Participants took part in 316 investigative sites in 24 countries from 29 Dec 2015 to 28 Jun 2019.|3890 participants were screened of which 2216 were randomized to 1 of the 5 treatment groups with a randomization ratio of 1:1:1:1:1.
720352|NCT02554760|Subjects seeking a reduction in fat in the flank area were recruited from the general population.|
720353|NCT02554682|Adolescents between 14 and 17 years of age with an upcoming well-child visit and a parent were recruited from January 2016 through September 2016 from one urban primary care practice in the Pediatrics Research Consortium (PeRC) at Children's Hospital of Philadelphia (CHOP).|A total of 425 parent-adolescent dyads were contacted and screened. Of these, 188 (44%) did not meet eligibility criteria, 26 (6%) declined, and 37 (9%) could not be scheduled or reached again. 174 participant dyads we randomized into one of the five assignment groups.
720354|NCT02554656||
720355|NCT02554435||
720356|NCT02554279|The study was conducted at 31 infertility centers in the US between 31 Aug 2014 to 02 Feb 2017.|
720357|NCT02554019|In total 36 subjects were enrolled in study parts I and II (18 in part I and 18 in part II). 12 subjects in part I received 50 mg BT063, 12 subjects in part II received 100 mg BT063. 6 subjects in part I and 6 subjects in part II received Placebo and were pooled for analysis. Only final results and no partial or interim results are presented.|
720358|NCT02553928||
720359|NCT02553915||
720360|NCT02553798||
720361|NCT02553772||
720362|NCT02553746||
720363|NCT02553629||
720364|NCT02553538||
720365|NCT02553512||
720366|NCT02553499||
720367|NCT02553421||
720368|NCT02553395||
727431|NCT01971580|Patients were recruited from Washington University School of Medicine Adult Congenital Heart Disease clinic between 10/2012 and 11/2014|
720369|NCT02553330|This study was conducted at 17 study centers in the United States.|Twelve participants were enrolled at 4 sites and were evaluable in the Part A treatment period; In Part B, 78 additional participants were enrolled at 17 sites.
720370|NCT02553317|A total of 145 subjects was randomized at 55 sites located in Europe (34 sites; 91 subjects), Asia (4 sites, 6 subjects), Australia (3 sites, 3 subjects), and North America (14 sites; 45 subjects). Consent was obtained from the first subject on 19 November 2015; the last subject completed the final visit on 16 August 2017.|Of the 149 subjects screened, 4 were screen failures and 145 were randomly assigned to treatment (Intent-to-treat [ITT] population). All, except 1 subject who withdrew consent, received study drug and were included in the safety population and in the modified ITT (mITT) population.
720371|NCT02553135||
720372|NCT02552966|Subjects were recruited from the Northwestern Medicine Gastroenterology clinic during the study period beginning 9/1/2015. A total of 15 subjects|
720373|NCT02552810|Eligible patients who met the inclusion criteria were asked to participate and were enrolled in consecutive order between January and September 2010 at the Department of Oral Surgery, University of Valencia.|
720374|NCT02552732||
720375|NCT02552368||
720376|NCT02552355||Participants were assigned to either Metformin-Protein, Metformin-Carbohydrate, Placebo-Protein, and Placebo-Carbohydrate.
720377|NCT02552316||
720378|NCT02552303||
720379|NCT02552238||
720380|NCT02552212|This ongoing study started to enroll participants in September 2015. The study included a Screening Period, up to 6 weeks before Baseline, a Double-Blind (DB) Period from Baseline (Week 0) to Week 52, that included the open label CZP (OL-CZP) treatment and other treatment (OT) and a Safety Follow-up Extension (SFE) Period, up to week 156.|The record presents interim results, up to Week 52. The Participant Flow refers to the Randomized Set (RS).
720381|NCT02552147||
720382|NCT02552121|For the Dose Escalation, participants took part in the trial at 3 sites located in Denmark, the United Kingdom (UK), and the United States (USA) from 30 Nov 2015 until 10 Feb 2017. Cohort Expansion trial was performed at 10 sites located in Belgium, UK, Denmark, and the USA from 16 Feb 2016 until the last participant visit on 13 Dec 2017.|
720383|NCT02551887|"Recruitment Period: May 15, 2014 - April 30, 2015
~Locations: The 5 CHICA clinic study sites were located throughout metropolitan Indianapolis. These clinics serve largely low income (70% Medicaid) and minority (33% Hispanic, 49% African American) children. CHICA has provided data to over 37,000 children since first implemented in 2004."|
720384|NCT02551874|This study was conducted at 112 centers in 11 countries from 20 Oct 2015 to 10 Nov 2017. There were 2 data cut-offs for this study: 8 May 2017 for analyses of the short-term study period (after 24 weeks of open-label treatment) and 10 Nov 2017 for analyses of the short-term plus long-term study period (after 52 weeks of open-label treatment).|The study duration was up to 56 weeks, consisting of a 2-week screening period, 2-week lead-in period, 24-week short-term treatment period, and 28-week long-term treatment period.
720385|NCT02551822||9 participants were withdrawn or lost to follow-up prior to randomization. 32 participants enrolled and 23 were randomized.
720386|NCT02551809||
720387|NCT02551770||Oversight. 1 extra patient was enrolled.
720388|NCT02551757||
720389|NCT02551744||
720390|NCT02551731||
720391|NCT02551692||37 participants were withdrawn from the study prior to treatment assignment due to either loss of interest, lost to contact, or inability to complete baseline procedures per protocol.
720392|NCT02551666||"151 prospective subjects were assessed for eligibility. 74 failed the medical screening 28 ended up declining to participate after learning more about the study 14 were withdrawn for other reasons not related to the study
~35 participants remained and were allocated to one of the two treatment groups."
720393|NCT02551653|Healthy volunteers and participants with Pulmonary Arterial Hypertension (PAH) were included in this study to evaluate the bio-distribution of [11C]- GSK2256098 in the lungs and heart using Positron Emission Tomography (PET).|A total of 14 participants were screened, of which 4 participants were screen failures. Remaining 10 participants were included in the study.
720394|NCT02551432||
720395|NCT02551224||
720396|NCT02551094||
720397|NCT02551055|Participants took part in the study at 3 investigative sites in Spain and the United States from 15 October 2015 to 18 January 2017.|Participants with solid advanced tumors were enrolled in Part 1 to receive MLN1117 along with alisertib, paclitaxel, TAK-659 and docetaxel in 1 of 7 treatment regimens. In Part 2, participants with gastric or gastroesophageal junction adenocarcinoma were to be enrolled, however, study terminated before initiation of part 2.
720398|NCT02550873|One hundred fifty-one (151) patients were screened for the study. Of these, one hundred seventeen (117) were found to be eligible and were randomized. One randomized patient dropped out of the study prior to receiving any study drug.|
720399|NCT02550795||There was no one who excluded before assignment to groups
720400|NCT02550652||A total of 126 patients were enrolled in the study however one patient randomized to obinutuzumab did not receive study treatment due to a positive pregnancy test, but prior to the first study drug infusion; therefore a total of 125 patients are included in the analysis.
720401|NCT02550288||Study consisted of screening, a 2-week placebo run-in and a 12-week treatment period.
720402|NCT02550210||
720403|NCT02550197|The study participants were enrolled from 11 September 2015 to 03 November 2015 at 5 clinic sites in the Republic of Korea.|A total of 300 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
720404|NCT02550132||
720405|NCT02550106|Full Analysis Set|
720406|NCT02549859|15 patients were screened for eligibility at a hospital-associated specialty clinic in Chicago, IL.|Eleven of 15 screened participants were enrolled; four did not meet inclusion/exclusion criteria. Five of the enrolled participants had participated in a previous study and had been treated on 60Hz DBS since then; their Visit 1 (V1) measurements were taken from the previous study.
720407|NCT02549755||
720408|NCT02549716||
720409|NCT02549573||
720410|NCT02549508||
720411|NCT02549365||
727432|NCT01971567||
730043|NCT01790685|40 patients from the clinic population of the Wilmer Eye Institute were recruited,|
720412|NCT02549352|391 participants were enrolled, 80 were screening failures, and 311 participants were randomized. Only 310 of the randomized participants were treated with investigational medicinal product (IMP), the number of participants treated is reflected as the number of participants started in the first period.|
720413|NCT02549339|A total of 383 participants were enrolled across 5 countries: United States, Canada, Germany, Spain, and Italy. 74 were screening failures, and 309 participants were randomized to 1 of the 2 treatment groups.|
720414|NCT02549287|Eligible participants were caregivers 18 or older, receiving services from a randomized provider, and had a child five or under. Participants were introduced to the study opportunity by their provider during a visit who referred interested participants to the Georgia State University-based research team to review the study procedures.|
720415|NCT02549196||A total of 28 subjects between the chronological ages of 50 and 89 years with dementia of Alzheimer's type were enrolled in the study.
720416|NCT02549040||
720417|NCT02549027||Participants were randomized to 1 of 4 treatment sequences of single doses of MK-1064 or placebo, administered over 4 study periods in a crossover design; then in Period 5 participants received, according to separate randomization, either a single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population.
720418|NCT02549014|Healthy male participants aged 18-45 years (inclusive) were recruited for this study.|
720419|NCT02548962||
720420|NCT02548845||
720421|NCT02548754||
720422|NCT02548728||
720423|NCT02548650||Between March 2016 and October 2018, 71 patients agreed to participate in the study; 5 patients were not eligible for randomization due to the presence of an exclusion criteria. 66 patients (DM, n=30; non-DM, n=36) were exposed to at least one dose of study medication, representing the safety population.
720424|NCT02548585|The study was conducted from 09 Dec 2015 to 24 Feb 2017 in Germany.|A total of 422 participants were screened, of which 113 participants were randomized in the study.
720425|NCT02548455||
720426|NCT02548312||
720427|NCT02548156|Participants were recruited at one Centre United Kingdom.|A total of 59 participants were screened, out of which 29 were randomized. Of the 29 randomized participants, 28 completed the study.
720428|NCT02548143||
720429|NCT02548078||
720430|NCT02547987||Patient eligibility is confirmed by both the study coordinator and a Lester & Sue Smith Breast Center physician. If a patient does not meet an inclusion criterion, or meets an exclusion criterion, as listed in the protocol section, the patient is excluded.
720431|NCT02547974|120 subjects were enrolled in the study. All subjects received at least one dose of the vaccine.|For each subject, the study lasted approximately 15 months, from screening (Pre-Day 0) to study end (Day 420). Vaccination schedules: 0, 2 months (i.e. at Day 0 and Day 60).
720432|NCT02547935|Patients with Chronic Kidney Disease and Type 2 Diabetes Mellitus with micro- or macro-albuminuria and treated with ACEi or ARB were enrolled into an international, multi-centre study from 21 Sep 2015. The last patient's last visit was 18 May 2018.|Enrolled patients were screened during a 4-week single-blind placebo lead-in period. Patients who met all of the inclusion and none of the exclusion criteria in this period were eligible to be randomised into the 24-week double-blind placebo-controlled treatment period.
720433|NCT02547779|The Isotonic Solutions and Major Adverse Events Trial (SMART) was registered for the medical ICU (NCT02444988), which enrolled 5381 patient beginning on June 1 2015, and then for the surgical ICUs (NCT02547779), which enrolled 10,421 patients beginning on October 1 2015. The overall SMART trial enrolled 15,802 patients and ended on April 30 2017.|
720434|NCT02547766||
720435|NCT02547714||The overall treatment period consisted of a 4 week induction period (Day 1 and weeks 1, 2, 3 and 4) and a 12 week maintenance period (weeks 8 and 12). All participants entered and completed both periods.
720436|NCT02547649|Healthy, pneumococcal vaccine-naïve adults ≥50 years of age were recruited at 23 sites in the United States.|
720437|NCT02547623|The first patient was enrolled into the study on 06 November 2015 and the last patient completed the study on 16 August 2016.|Of the 194 patients randomized, 181 patients were dosed and included in the ITT (intent-to-treat) and safety analysis sets. 13 randomized patients were not dosed and terminated from the study. Some of the patients that were not dosed had at least one significant protocol deviation.
720438|NCT02547454||
720439|NCT02547363|373 participants were enrolled, 57 were screening failures, and 316 participants were randomized. Only 313 of the randomized participants were treated with investigational medicinal product (IMP), the number of participants treated is reflected as the number of participants started in the first period.|
720440|NCT02547233|A total of 437 participants were enrolled across 4 countries: United States, United Kingdom, France, and Spain. 130 were screening failures, and 307 participants were randomized to 1 of the 2 treatment groups|
720441|NCT02547220|The study was conducted at 49 sites between 20 May 2016 (first participant first visit) and 31 May 2019 (last participant last visit).|A total of 39 participants were randomized and received treatment.
720442|NCT02547129||
720443|NCT02547064||
720444|NCT02547038|recruitment period: August 2015 through February 2017. Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital|None were excluded following participant enrollment.
720445|NCT02547012|recruitment period: Oct 2013 - Jul 2017 Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital|None were excluded following participant enrollment.
720446|NCT02546986|This study was a multicenter study with 25 sites from the United States, France. Germany, Italy, and Spain.|Qualified participants were randomized in a 1:1 ratio to one of the two treatment groups. Randomization was stratified by cancer histology (non-squamous versus squamous).
720447|NCT02546856||
720448|NCT02546765||After signing the informed consent, 19 withdrew prior to randomization. (8 patient withdrawals, 8 found ineligible, 1 withdrawn because of inappropriate behavior and emotional lability, 1 withdrawn after entering and receiving intervention in another trial, 1 withdrawn because of inability to complete baseline assessment for same-day admission)
721401|NCT02458092|30 healthy, malaria-experienced adults were enrolled and randomized into 2 groups at Walter Reed Project/Kenya Medical Research Institute (KEMRI) Kisumu, Kenya.|
734488|NCT01500252||
720449|NCT02546609|Subjects meeting all inclusion criteria and no exclusion criteria were randomized to one of the three treatment arms in the ratio of 1:1:1. Adult males and females (age 18-75) with CT, MRI, biopsy, or ultrasound consistent with NAFLD within the past 6 months.|
720450|NCT02546570||
720451|NCT02546544|Patients were recruited from March 2014 until April 2016 at specialist cancer hospitals across Europe|
720452|NCT02546388||
720453|NCT02546375||
720454|NCT02546362||
720455|NCT02546323|Chinese patients with subclinical atherosclerosis and a 10-year ischemic cardiovascular disease (ICVD) risk of less than 10% (as assessed by the 2007 China Adult Dyslipidema Management Guidelines) were enrolled at 25 sites in China between 17 September 2015 and 29 January 2019.|Eligible patients with carotid intima-media thickness (CIMT) measurements of maximum CIMT ≥1.2 millimeters (mm) and <3.5 mm were randomized to receive either rosuvastatin 20 milligrams (mg) or corresponding placebo once daily. Randomization was stratified by ICVD risk (<5% or 5% to 10%).
720456|NCT02546193|Women were enrolled in the outpatient obstetric clinic approximately 2-4 weeks prior to their scheduled induction of labor.|Women were excluded from the study prior to randomization (the day before their scheduled induction of labor) due to spontaneous onset of labor or other maternal/fetal concern necessitating delivery prior to scheduled induction date.
720457|NCT02545933||
720458|NCT02545868|The study recruited participants with relapsing forms of multiple sclerosis in 2 countries from 27 October 2015 to 14 February 2017.|A total of 122 participants were screened of which 102 participants were randomized.
720459|NCT02545608||
720460|NCT02545543|First Patient In: 14-SEP-2015, Last Patient Last Visit: 13-JUN-2016. Number of activated sites that enrolled subjects: 32 (all based in USA).|Number of subjects screened: 2349. Number of subjects randomized: 2278
720461|NCT02545504|Participants were enrolled at study sites in Australia, Europe, Chile, Colombia, Peru, Turkey, and the United States. The first participant was screened on 13 October 2015. The last study visit occurred on 15 May 2019.|635 participants were screened.
720462|NCT02545322||
720463|NCT02545270||
720464|NCT02545101||
720465|NCT02545075||182 participants were enrolled, 68 were not randomized, reasons for not being randomized:3 participants withdrew consent and 65 no longer meet study criteria.
720466|NCT02544984||
720467|NCT02544763||A total of 255 participants were screened; 31 of whom were screen failures. A total of 224 participants were randomized to double-blind treatment.
720468|NCT02544633||Sponsor approval of each potential patient's genetic testing following prescreening, whether performed by the study central lab or a Sponsor-approved local lab, was filed prior to proceeding to full clinical screening. All patients considered eligible for the study following clinical screening were submitted to Sponsor for registration approval.
720469|NCT02544607|As specified, the total number of participants enrolled are those who agreed to participate in the study following completion of the informed consent process (n=25). This number does not reflect the number of subjects who actually started treatment (n=16).|
720470|NCT02544451|This study consists of 2 Treatment Periods: Treatment Period 1 and Treatment Period 2. Treatment Period 1 has completed and Treatment Period 2 is ongoing. Primary Completion was achieved based on Treatment period 1 in August 2018. Only Treatment Period 1 results are reported. Complete results will be updated within 1 year of study completion.|Participants from Parent Studies 109 (NCT02514473) and 011B (NCT01897233) were enrolled in this study. A total of 240 participants were enrolled in Treatment Cohort, out of which 1 participant was enrolled but never dosed. Participants enrolled in the Observational Cohort were followed for safety endpoint only, no efficacy data were collected.
720471|NCT02544217|All studies were conducted at the Drug Research Unit Ghent. Participants agreed to stay in the Drug Research Unit during the first 24 h after dosing (SAD) and during Day 8 (MAD).|
720472|NCT02544152||
720473|NCT02544074||The eSAGE test is scored from 0-22 with 22 indicating a perfect score.
720474|NCT02543918||
720475|NCT02543892||
720476|NCT02543840||
720477|NCT02543801|"Hip Cohort: Enrollment began January 2016 and ended October 2017. Patients were recruited sequentially from a single orthopedic surgeon's practice.
~Knee Cohort: Enrollment began January 2017 and ended August 2018. Patients were recruited sequentially from three orthopedic surgeon practices."|Patients would be excluded if surgery was cancelled or for some clinical reason did not receive the periarticular injection during surgery.
720478|NCT02543658|Between Sept 1, 2015, and Aug 15, 2017, we measured intra-abdominal pressure on patients with acute pancreatitis and selected patients with intra-abdominal hypertension, in the Pancreatic Intensive Care Unit of the Department of Gastroenterology, the First Affiliated Hospital of Nanchang University.|Acute pancreatitis patients with intra-abdominal hypertension were first treated with conventional non-surgical therapy(such as: Enteral decompression with nasogastric and rectal tube,Glycerin enema, percutaneous drainage of ascites) for 24 hours. After 24 hours, the intra-abdominal pressure was still above 12 mmHg and they were randomized.
720479|NCT02543554||
720480|NCT02543528|This study utilized an adaptation period of 14 days prior to dispensing the extended wear contact lenses. A total of 171 subjects were enrolled into the adaption period. Of those enrolled into this period 168 were dispensed a study lens and 3 did not meet the eligibility criteria. Of the 168 dispensed subjects 142 completed the adaptation period.|A total of 26 subjects were discontinued from the adaptation period. A total of 142 subjects were enrolled into the extended wear period. Of the enrolled subjects, all 142 were dispensed a study lens. Of the dispensed subjects in the extended wear period 58 completed the study and 84 subjects discontinued from the study.
720481|NCT02543437||117 participants / 120 hips enrolled in study.
720482|NCT02543398|Location: Graduate Periodontics clinic at the University of Texas Health Science Center at San Antonio (UTHSCSA), San Antonio, Texas Date: January 2014 to May 2015|
720483|NCT02543346|A total of 149 individuals were screened across both study sites; 78 individuals were screened at the Environmental Exposure Unit in Kingston, Ontario, Canada. 71 individuals were screened at the Biogenics Research Chamber in San Antonio, Texas, USA.|A total of 98 of 149 individuals were randomized (51 individuals for the Environmental Exposure Unit, 47 individuals for the Biogenics Research Chamber). Of those not randomized, 5 did not meet inclusion criteria, and 46 were discontinued prior to randomization due to not meeting eligibility criteria.
720484|NCT02543294|Patients were identified in the Cardiology outpatient clinic at MD Anderson Cancer Center by research team. Team reviewed cardiac medications (angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin II receptor blocker (ARB), and beta blocker), met with eligible patients, explained study, obtained informed consent, and enrolled in the study.|
720485|NCT02542943||A total of 262 participants were screened, out of which 240 participants were randomized and 238 completed the study.
720486|NCT02542865|Participants were recruited from 4 schools in India.|Total 958 participants were screened. Of these, 924 participants were enrolled for randomized treatment, of which, 2 participants withdrew their consent before starting the treatment. 34 participants were not enrolled, of which, 11 did not meet study criteria, 22 had withdrawal of consent and 1 identified as screen failure.
720487|NCT02542761|Subjects were recruited at Mayo Clinic in Rochester, Minnesota.|
720488|NCT02542631||
720489|NCT02542605|Participants were enrolled in 2 centers in Belgium and the Netherlands from November 2015 until November 2017 when the study was terminated early due to slow recruitment rate. Additionally, 2 participants were enrolled at a center in the United States for Part A prior to this study site being closed.|12 participants received treatment in Part A to determine the lowest pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) dose that triggered a migraine-like attack (MLA). PACAP-38 responders from Part A and PACAP-38 naïve participants were randomized in Part B (17 in total). 35 participants were enrolled in the study (Parts A and B).
720490|NCT02542462|During the study period, there were 252 children screened and of these, 238 were eligible for enrollment. These subjects were identified through screening at a primary care clinic and through advertisement|43 of 144 enrolled participants withdrew prior to randomization
720491|NCT02542410||
720492|NCT02542280|Patients were recruited from the infertility clinic and given appointments to go to the Assisted Reproductive Technology unit to start the process of IUI.|11 patients were excluded because they did not show up for their appointments in assisted reproductive technology unit.
720493|NCT02542267||
720494|NCT02542072||
720495|NCT02542046||
720496|NCT02541942|The trial was conducted at 16 sites in 7 countries, as follows: Greece: 2 sites; Japan: 3 sites; Malaysia: 1 site, Romania 1 site, Serbia: 2 sites; Thailand: 2 sites; United States: 5 sites.|This trial describes pharmacogenetic testing of saliva samples from patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue.
720497|NCT02541903|The study was open to accrual between 10/6/2015 and 2/26/2019. Two sites were involved - the University of Alabama at Birmingham, and the University of Southern California.|
720498|NCT02541864||
720499|NCT02541812||
720500|NCT02541669|Participants took part in the study at 1 investigative site in China from 17 November 2015 to 17 March 2017.|Healthy Chinese participants were enrolled in the study in 2-parts, Open-label in which participants were allocated equally and randomly to TAK-491 40 milligram (mg) and TAK-491 80 mg and Double-blind in which participants were allocated equally and randomly to 1 of 3 regimens Placebo, TAK-491 40 mg, and TAK-491 80 mg.
720501|NCT02541604||
720502|NCT02541565||
720503|NCT02541422||62 people were enrolled however only 49 were included in the analysis due to not submitting their surveys or did not complete the first day of the study.
720504|NCT02540850||
720505|NCT02540772|Patients were recruited during the period between April 2013 and April 2015 at the San Rafael Hospital where they were admitted for rehabilitation after acquired brain injury.|Due to the absence of confabulations in the Dalla Barba interview two participants were excluded. Another two participants were excluded because a deficit in alertness.
720506|NCT02540668||
720507|NCT02540629||
720508|NCT02540538|This phase I study involved two trials: a double-blinded RCT in naïve participants and an open-label study in a cohort of true non-responders. At the first visit, a physical examination was performed and blood and urine sampling were taken, and informed written consent was required to participate in the study.|"In RCT, 27 recruits, 3 naïve participants exclusions:
~1 with liver LFTs abnormalities
~1 with anti-HBs-AB >10 mIU/mL
~1 with suspicion of Cushing's syndrome Thus, 24 healthy participants were included.
~In the open-label study, 10 true non-responders were screened, then included. All participants were between 18 and 59 years of age."
720509|NCT02540447|Candidates recruited from patients admitted for living donor liver transplantation in Mansoura liver transplantation unit|
720510|NCT02540434|All subjects undergoing cardiac surgery requiring cardiopulmonary bypass at Weill Cornell Medicine who dont meet exclusion criteria will be invited to participate prior to surgery. They will be recruited after admission to the hospital the day before surgery. If the subject consents to participate, they will be enrolled. Not all will be randomized.|Enrolled subjects will have initial blood sample taken for baseline ROTEM in the beginning of surgery. During rewarming, the next ROTEM will be run to assess for a FIBTEM A10 < 10. If It is less than/equal to 10, subject will be randomized. If microvascular bleeding is detected subject will get intervention. Note: only 2 subjects were randomized.
720511|NCT02540356|2 participants were enrolled for this study and 1 participant was a screen failure. Study was stopped early with only 1 participant having been dosed.|
720512|NCT02540291|Participants took part in the study at 2 sites in the United States and 1 site in France from 30 July 2015 to 27 February 2018.|A total of 31 participants with advanced malignancies were enrolled, of which 30 participants received study treatment. The study was terminated before the start of the cohort expansion part. The discontinuation of participants from study is presented in the overall study table below.
720513|NCT02540265||
720514|NCT02540226||
720515|NCT02540213||
720516|NCT02540161||43 patients signed consent and were considered enrolled, however 3 patients withdrew consent prior to treatment and 1 patient was withdrawn by PI prior to treatment.
720517|NCT02540083||
720518|NCT02539992|56 patients have been screened for study participation. No patient withdrew his/her informed consent.|12/56 patients received another procedure. Therefore 44 patients were enrolled in 4 centers.
720519|NCT02539797||
720520|NCT02539654|Participants were recruited from 2 investigational sites located in the US.|All 14 enrolled participants were treated. This reporting group includes all enrolled participants (14).
720523|NCT02539368||A total of 2565 participants were enrolled in the study, out of which 22 participants were not eligible to receive treatment for any of the treatment groups. Hence, only those participants who received treatment during the study observation period were included in the participants flow section.
720524|NCT02539342||
720525|NCT02539225|Completers are defined as participants who died or those who were alive and off treatment at study completion.|
720526|NCT02539134|Participants took part in the study at 1 investigative site in the United States from 02 September 2015 to 19 April 2016.|Healthy participants received TAK-935 or placebo in Cohorts 1-5: 100 milligram(mg) once daily(QD), 300mg QD, 300mg twice daily(BID), 600mg QD, and 400mg QD respectively in Part 1. Study Part 2 (optional) was not conducted after review of initial data of TAK-935-1003(NCT02497235) along with safety and tolerability data from Cohorts 1 to 4 of Part 1.
720527|NCT02539108|Study participants were enrolled from 31 August 2015 to 30 November 2015 at 2 clinic centers in the United States.|A total of 60 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
720528|NCT02538965|Participants were enrolled at 15 centers within the United States and Canada.|The study population consisted of pediatric participants with relapsed or refractory Acute Myeloid Leukemia (rrAML) from 1 to ≤ 18 years of age and were required to have a fresh bone marrow aspirate and biopsy submitted for confirmation of disease.
720529|NCT02538783||
720530|NCT02538679||
720531|NCT02538666||1212 participants enrolled; 834 randomized. 378 Not Randomized. Reasons not randomized: 2 Adverse events, 31 withdrew consent, 2 lost to follow up, 3 poor/non-compliant, 334 no longer met study criteria, 5 not reported, 1 other therapy was proposed
720532|NCT02538614|Participants were enrolled at study sites in the United States. The first participant was screened on 29 December 2015. The last study visit occurred on 05 July 2017.|5 participants were screened. Due to the early study termination, phase 2 was not initiated. Enrollment to this study was closed during Phase 1b. The 2 enrolled participants were allowed to remain on the study.
720533|NCT02538523||
720534|NCT02538510||
720535|NCT02538471||
720536|NCT02538419||
720537|NCT02538354||
720538|NCT02538107||
720539|NCT02538094||
720540|NCT02538042|This study enrolled adult daily smokers from the Raleigh-Durham region in North Carolina who reported interest in quitting smoking|Eighty-seven participants were enrolled and assessed for eligibility. Thirty-eight of those did not meet inclusion criteria (n=29), or withdrew (n=7) or were lost to contact (n=2) prior to baseline. Forty-nine participants completed the baseline cue-reactivity session and 34 returned for their randomization visit.
720541|NCT02538029||
720542|NCT02538016|Recruitment and Enrollment period was between August 2016 to December 2018. Subjects were recruited from our existing database of cystinuria patients, from new patients presenting during the research period, and via advertising through the International Cystinuria Foundation, Rare Kidney Stone Consortium, and social media.|Of 6 eligible and interested participants, 5 met inclusion criteria and were consented, and of these, 1 withdrew prior to travel to our hospital for drug administration.
720543|NCT02537951||"all 10 healthy volunteers underwent 3 experiments, all 10 have completed these experiments:
~AFI intensity measurements
~lidocaine/prilocaine creme, one hour later followed by AFI intensity measurements
~capsaicin patch (2 hours after lidocaine/prilocaine creme), one week later followed by AFI intensity measurements"
720544|NCT02537873|29 participants enrolled and passed screening. 4 withdrew or were terminated prior to randomization resulting in 25 randomized participants.|
720545|NCT02537730||
720546|NCT02537717||
720547|NCT02537574|Adults with opioid use disorder who were voluntarily seeking treatment were eligible to enroll.|Two subjects were randomized, but did not receive study drug. Four subjects attempted enrollment at multiple sites. The data collected on these subjects during their second enrollment was excluded from the efficacy analyses.
720548|NCT02537522||A total of 72 subjects were enrolled into this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 71 were dispensed lenses. Of the dispensed subjects 45 completed both Phase I and II while 26 subjects were discontinued.
720549|NCT02537444||
720550|NCT02537431||
720551|NCT02537015||Participants who completed the Phase 2 study FSV5-004 [NCT02358369] were eligible to enroll in this open-label extension study.
720552|NCT02536976|Participants were recruited in a single site from an ambulatory patient population of a dedicated Parkinson's Disease Center. First participant was screened in 12/2015 and the last participant completed the study in January 2018|17 participants signed the ICF. There were 10 screen failures. 7 participants enrolled. 2 participants withdrew consent before starting study drug, and 1 was terminated during the placebo run-in phase due to unrelated failing health. 4 participants completed all study activities.
720553|NCT02536963||
720554|NCT02536833||
720555|NCT02536781||
720556|NCT02536664||Fifteen out of 505 participants were screen failure and excluded from the baseline and safety data sets. Safety Set Overall (SSO) included 490 participants who received at least 1 dose of study drug in/during the maintenance period. Therapy line was not reported for 1 participant and participant flow was reported for 489 participants.
720557|NCT02536378||
720558|NCT02536339||
720559|NCT02536313|Participants were enrolled at 1 study site in the United States. The first participant was screened on 29 July 2015. The last study visit occurred on 28 June 2016.|
720560|NCT02536248||
720561|NCT02536105||88 individuals signed consent. 82 individuals were eligible for the study. 80 individuals were exposed to the open-label phase (Methylphenidate HCL ER Tablets 1). 76 individuals entered the double-blind phase. 72 individuals completed the entire study. Since this is a crossover study, these were the same individuals (88 consented, not 301).
720562|NCT02536040||
720563|NCT02535806||
720564|NCT02535741|The first patient included in the study was enrolled in October 2006. 168 cases received the Triathlon CR knee system over a 56 month period in a consecutive manner in 6 centers.|
720565|NCT02535715||Subjects will be assigned to all 3 interventions during the study. One intervention will be assigned at a time, but in random order, with a 3 day to 4 week interval between interventions.
720566|NCT02535611||
720567|NCT02535481|A total of 61 patients were screened for eligibility; 44 of them fulfilled the inclusion criteria and were randomized to the two study groups (EG and SSG) between October 2015 and September 2017. Participants were recruited at the Royal Free London NHS Foundation Trust Hospital.|
720568|NCT02535416||
720569|NCT02535364|A total of 82 participants were enrolled at 15 study centers within the United States.|Participants were adults with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL).
720570|NCT02535065||
720571|NCT02535026||
720572|NCT02535000|The study was started in January, 2014 at the Centro Hospitalar Unimed of Joinville, Brazil|
720573|NCT02534935||
720574|NCT02534896||
720575|NCT02534883||
720576|NCT02534493||Participants were only enrolled if a nerve conduction study (NCS) was performed at the enrollment visit or within the past 6 months, electrodiagnostically confirming the presence of mild to severe CTS.
720577|NCT02534350|Participants were enrolled at sites in Europe, North America, and Australia.The first participant was screened on 31 December 2015 and the last study visit occurred on 27 September 2017.|111 participants were screened.
720578|NCT02534324|Patients >= 18 years old who presented in ED with systolic BP >=180 mmHg and diastolic BP >= 100 mmHg were enrolled. The patients with minor chief complaints that were not related to severe hypertension or those who presented to hospital for routine outpatient visits and were referred to ED due to severe hypertension were included.|
720579|NCT02534285|Recruitment period from 09-04-2015 until 11-22-2016|
720580|NCT02534129||13 patients were entered, each of whom had a single radiation port divided into two fields. One received aquaphor protection and the other received Difinsa53 protection.
720581|NCT02534038||
720582|NCT02533999||
720583|NCT02533921||
720584|NCT02533726||
720585|NCT02533570||
720586|NCT02533531||
720587|NCT02533505|This study was conducted at 5 sites in the United States (US) between 25 August 2015 and 12 August 2016.|This was a Phase 4, randomized, double-blind, multi-center, placebo-controlled, 2 way cross over study to evaluate changes in oxygen consumption and cardiac function in COPD patients with resting hyperinflation after administration of Symbicort pMDI. The study consisted of 5 site visits and 1 phone visit for a total study duration of 6 weeks.
720588|NCT02533466|Participants were recruited at 1 center in United Kingdom.|A total of 30 participants were screened and all of them were randomized.
720589|NCT02533453|Participants recruited from 15 hospitals in South Korea between Jan 2016 and Jul 2016.|115 subjects were participated: 5 failed screening without treatment with the study drug.
720590|NCT02533427|Participants were enrolled at a study site in New Zealand. The first participant was screened on 29 October 2015. The last study visit occurred on 18 March 2016.|15 participants were screened.
720591|NCT02533401||
720592|NCT02533375||The Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment.
720593|NCT02533258||
720594|NCT02533167|Subjects were approached in the preoperative holding room area regarding participation in this study. Subjects were electively scheduled to have a cesarean delivery with proposed healthy outcomes with term deliveries.|
720595|NCT02533089|103 health centers enrolled, a total of 1153 patients|109 health centers assessed for eligability, 6 health centers excluded as TB care not provided at the health center: all patients registered for TB care with treatment start and end dates within the study period included
720596|NCT02533063||
720597|NCT02532998|This study was conducted at PAREXEL Early Phase Clinical Unit London, United Kingdom|This study had a single-blind, randomized, 4-treatment, 4-period crossover design (William's design). A total of 40 participants were enrolled (signed ICF) in this study, of which 23 participants were randomized to receive the study medication.
720598|NCT02532972||
720599|NCT02532933||
720600|NCT02532855|This study was conducted at 183 medical centers in 24 countries.|Male and female participants, 25 years or older, with Type 2 diabetes mellitus (T2DM) and mild renal impairment on metformin alone or in combination with a sulfonylurea (SU) agent were enrolled in this trial.
720601|NCT02532764|The enrollment of this clinical trial followed a staggered approach; a new SAD cohort was enrolled following review of the previous SAD cohort. The first MAD cohort opened following the review of the first two SAD cohorts. Subsequent MAD dosing cohorts were initiated following review of the corresponding supportive SAD and MAD cohorts.|
720602|NCT02532647||
720603|NCT02532556||
720604|NCT02532543||
720605|NCT02532517||
720606|NCT02532465||
720607|NCT02532374|"Study initiated (1st subject screened): 07 October 2015
~At admission, all the subjects were to try the P3L (50 μg/puff) and Nicorette® inhalator.
~Smoking or use of any tobacco/nicotine-containing products or electronic cigarettes, apart from product use assigned on the assessment days, was not allowed during the visits on site."|"Enrolled population = 16 subjects
~All enrolled subjects met all of the inclusion and none of the exclusion criteria for the study."
720608|NCT02532283||In total, 102 participants were randomized. 3 participants were randomized but not treated due to withdrawal of consent before treatment start. Therefore, the Safety Set, comprising all participants who received at least 1 dose of study drug(s), consisted of 99 participants.
720609|NCT02532179||
720610|NCT02532036||
720611|NCT02532010||
720612|NCT02531971||
720613|NCT02531867|There were 11 study sites, all in Japan; 13 patients were enrolled into this study. The first patient signed informed consent in June 2015; the study continued through November 2015 at multiple centers in Japan.|
720614|NCT02531802||
720615|NCT02531698||
720616|NCT02531646||
720696|NCT02522715|Phase I accrual occurred between November 2015 and April 2016. Phase II accrual occurred between January 2017 and March 2019. The last follow-up date is anticipated to be August 2025.|One participant withdrew before receiving study treatment and was therefore excluded from safety and efficacy analysis.
721402|NCT02457910|13 enrolled in Phase Ib and 17 in phase II|13 in phase Ib and 17 in phase II
721403|NCT02457897||
720617|NCT02531633|This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of sirukumab in treatment of participants with Giant Cell Arteritis (GCA). A total of 161 participants were enrolled.|This study was conducted in 2 distinct parts (Part A and Part B), Part A was a 52-week double-blind treatment phase and Part B was a 104-week long-term extension phase with the option to receive open-label sirukumab (SIR) (up to a 52-week duration of open-label treatment). This study was terminated early by sponsor.
720618|NCT02531438|Participant randomization was stratified by Pneumonia Outcomes Research Team (PORT) Risk Class (II or III/IV), receipt of an allowed antibacterial therapy in the 72 hours prior to study treatment, and geographic region. All participants were expected to present with CABP severe enough to require at least 3 days of intravenous (IV) treatment.|Participants who met inclusion criteria and did not meet exclusion criteria were randomly assigned to a treatment group, and received their first dose of test article within 4 hours after randomization. All participants were expected to present with CABP PORT Risk Class II, III, or IV to require a minimum of at least 3 days of IV treatment.
720619|NCT02531373||
720620|NCT02531321||
720621|NCT02531308||
720622|NCT02531113|Sixty-nine adult participants were enrolled from 28 sites located in Europe and North America.|Eligible participants must have had a Crohn's Disease Activity Index (CDAI) score of 220 to 450 inclusive with an Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 and an average daily stool score ≥ 4 points and/or an average daily abdominal pain score of ≥ 2 points.
720623|NCT02531035|Participants took part in the study at 133 investigative sites across 19 countries: Poland, Slovakia, Spain, United Kingdom, Belgium, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Argentina, Australia, Canada, Colombia, Israel, New Zealand, South Africa and United States from 18 September 2015 to 18 April 2017.|1405 participants with a diagnosis of Type 1 Diabetes were enrolled equally in 1 of 2 treatment groups: placebo or sotagliflozin 400 milligrams (mg).
720624|NCT02531022||
720625|NCT02530970||
720626|NCT02530671||
720627|NCT02530619|The study opened for accrual on October 09, 2015 with an accrual goal of 24 patients. The first patient started treatment July 05, 2016. The study closed November 02, 2017 with total accrual having been met.|
720628|NCT02530554|Upon achieving sufficient microbial growth prior to product application on either the abdomen and groin regions, sites of the participant were then randomized to received two products for an evaluation or up to 4 sites.|Participants were randomized to be treated with at least 2 treatments/ Arms at the same time for both groin and abdomen. Total numbers represent participants.
720629|NCT02530515||Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.
720630|NCT02530476|Recruitment Period: December 2015 to July 2018|
720631|NCT02530450||
720632|NCT02530385||
720633|NCT02530294||
720634|NCT02530281||
720635|NCT02530242||
720636|NCT02530151||
720637|NCT02530125|The study opened for accrual on August 4, 2016 with an accrual goal of up to 30 patients. The manufacturer of pidilizumab requested accrual be suspended on November 15, 2016 and the study was permanently closed to accrual. The manufacturer discontinued pidilizumab due to issues with supply. 4 patients were registered and treated with pidilizumab.|
720638|NCT02529995|All patients were enrolled in China: first patient enrolled on 24-08-2015. The recruitment was closed following LSI. The primary analysis for the PK was performed at the data cut off (DCO1): 28-01-2016. The study was on-going until the final analysis for the efficacy & safety at the data cut off (DCO2): 02-11-2016 and the study is completed.|36 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 4 patients were enrolled but failed inclusion/exclusion criteria and 1 patient withdrew consent so were not eligible to be assigned treatment. The remaining 31 patients received treatment.
720639|NCT02529553||"Part A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle.
~Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle."
720640|NCT02529488|Subjects were recruited from 17 study centers located in Australia (4), Chile (3), Germany (2), Italy (2), Spain (2), Belgium (1), Great Britain (1), France (1), and Netherlands (1).|Of the 167 enrolled, 16 subjects were exited as screen failures prior to being implanted. An additional 2 subjects satisfied the eligibility criteria for the study, but were also discontinued prior to being implanted. This reporting group includes all implanted subjects (149).
720641|NCT02529137|Case enrollment started in October 2015 and enrollment was completed in December 2015. A total of 2000 cases was enrolled. Eight cases were discontinued before reading, resulting in a total of 1992 cases for reading.|"In total 2000 cases were planned to be enrolled, divided over the clinical study sites.
~A total of 2000 cases were enrolled, between 390 and 600 cases per site over four sites."
720642|NCT02529072||
720643|NCT02528786|Participants took part in the study at 5 investigative sites in The Netherlands, Bulgaria, and Spain from 19 November 2015 to 05 April 2016.|Participants with a historical diagnosis of mild or moderate rheumatoid arthritis who received namilumab (MT203) in the study M1-1188-002-EM (NCT01317797) were enrolled in this study to obtain and analyze a blood deoxyribonucleic acid (DNA) sample.
720644|NCT02528721||
720645|NCT02528643|Participants were enrolled from 37 sites in 9 countries in Europe, Asia, and North America. Participants with hepatocellular carcinoma (HCC) of any etiology whose disease had progressed on or who were intolerant to sorafenib or other antivascular endothelial growth factor (VEGF) therapy in the advanced setting were enrolled.|Eligible participants were stratified by geographic region (Asia vs other) and Eastern Cooperative Oncology Group (ECOG) performance (0 vs 1) and randomized in a 2:1 ratio. Participants who discontinued treatment entered a follow-up period (30-day and long-term up to 2 years). Results for data collected up to cut-off 02 Oct 2017 are reported here.
720646|NCT02528500||
720647|NCT02528409||
720648|NCT02528331||
720649|NCT02528318||
720650|NCT02528305||
721404|NCT02457819||
721405|NCT02457793||
721406|NCT02457728||
734489|NCT01500226||
720651|NCT02528253|A total of 1832 participants were enrolled in the study, however, only those participants were included in participant flow section who received at least 1 dose of study drug.|Treatment period was up to Week 56. Safety follow up period started at Week 64, thus Weeks 64 and 80 time points were during safety follow up period. Percentage (%) reduction in low back pain intensity (LBPI) and participants global assessment (PGA) 2-point reduction are efficacy measures and not applicable during safety follow up.
720652|NCT02528214|The study was conducted at 68 centers in 17 countries. A total of 390 participants were screened between October 2015 & April 2017, of which,210 were randomized & treated. 180 participants were screen failures mainly due to exclusion criteria met & inclusion criteria not met. Assignment was done by Interactive Voice/Web Response System(IVRS/IWRS).|Screening period included an OCS optimization phase (up to 10 weeks) where participants using OCS other than prednisone/prednisolone switched to these OCS. At the end of period, participants were randomized in 1:1 ratio (dupilumab:placebo).Randomization was stratified by optimized OCS dose (=<10 & >10 mg/day) at randomization visit & by country.
720653|NCT02528188||
720654|NCT02528097||
720655|NCT02527694|Adult OHCAs transported by five ambulances in a metropolitan area with a population of 3.5 million (many of whom lived in high-rise buildings) from September to October (before-phase) and November to December (afterphase) in 2015 were collected.|
720656|NCT02527434|A total of 64 patients with select advanced solid tumors were treated in this phase II, open-label, multi-center study from November 2015. Primary data cut off date: 17 February 2018. Final data cut off date: 31 December 2018.|The patients were split into 3 different analysis cohorts based on their tumor types: urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC) and pancreatic ductal adenocarcinoma (PDAC).
720657|NCT02527161|Patients were assessed and then placed in either Part A or Part B. Patients in Part B were invited to participate in the extension follow-up to 5-years.|
720658|NCT02527148||For all results participants=knees.
720659|NCT02526693||
720660|NCT02526680||
720661|NCT02526667|Upon achieving sufficient microbial growth prior to product application on either the abdomen, groin or both abdomen and groin regions,sites of the participant were then randomized to receive one or two products for evaluation for up to 4 sites. Differences in the number of participants is based on microbial qualification.|The sites of the participant were tested for microbial activity after product application. In some instances, more than one product could have been applied to a participant but only one product per site (groin and/or abdomen sites). Up to 4 sites could be treated: 1) both groin and abdomen, 2) only the groin or 3) only the abdomen.
720662|NCT02526654|Patients were recruited from the Glaucoma Service at Wills Eye Hospital between December 2014 and June 2015. Healthy controls were recruited from staff, family and friends.|Before study tasks, Informed Consent was conducted and obtained according to the International Conference on Harmonization Good Clinical Practices (ICH GCP) guidelines with opportunity for all questions to be answered.
720663|NCT02526550|This phase IV study was conducted between 01 June 2014 and 04 July 2014 in accordance with ICH GCP. The study was approved by the Siriraj IRB. Written Informed Consent was obtained from all participants' parents or legal guardians before study entry.|
720664|NCT02526524||
720665|NCT02526290||
720666|NCT02526277||
720667|NCT02526212||
720668|NCT02525874|This study was conducted from 11 August 2015 to 23 April 2018 in Belgium, Bulgaria, Lithuania, Kuwait, Poland and United States.|A total of 218 participants were enrolled in the study of which 158 participants completed the study
720669|NCT02525744||
720670|NCT02525718||
720671|NCT02525653||
720672|NCT02525627||40 participants/hips - 6 participants/hips excluded during surgery = 34 participants/hips
720673|NCT02525588||Four patients were included into the study but not assigned to a group as prior to surgery two patients withdraw, one surgery was cancelled due to urinary tract infection and one patient met exclusion criteria BMI>40
720674|NCT02525575|During the life of the project, 45 subjects signed consent. Of those that consented 37 completed baseline assessments.|
720675|NCT02525536|Participants took part in the study at 1 investigative site in Japan from 26 June 2009 to 28 May 2014.|Participants with a historical diagnosis of advanced solid tumor were enrolled in 1 of 3 treatment groups: trebananib 3 milligram/kilogram (mg/kg); trebananib 10 mg/kg; trebananib 30 mg/kg.
720676|NCT02525523||
720677|NCT02525094|The study was conducted from 15Aug2015 to 15Jul2016.|A total of 155 participants were screened, of which 113 were randomized into the study.
720678|NCT02525055||
720679|NCT02524977||
720680|NCT02524847||Participants were recruited by multiple treatment centers in the United States and Europe
720681|NCT02524665|From September-2009 to December-2009, total 20 participants were randomized at one of center in Louisville. MAXCLARITY II™ is a trademark of Stiefel Laboratories, Inc and MURAD™ is licensed product of Murad Europe Limited.|Male or female participants 18 to 29 years of age with mild facial acne vulgaris, characterized by at least 24 facial inflammatory lesions (papules and pustules) and/or non-inflammatory lesions (open and closed comedones) on each half of the face (excluding nose and front hairline areas) were included.
720682|NCT02524561|Women in the parent study were approached to be part of this ancillary study (MDBHAS). For women who consented we attempted to collect their mammograms. Our collection took place after they started and were randomized in the parent study.|
720683|NCT02524418||
720684|NCT02524288||
720685|NCT02524158||
720686|NCT02524145|Recruitment initiated in June 2015 and completed October 2017. Subjects were recruited from academic medical center cardiology clinic. Healthy control subjects were recruited from the community.|
720687|NCT02524106||
720688|NCT02524054||
720689|NCT02523924||19 patients did not meet inclusion criteria.
720690|NCT02523690||
720691|NCT02523586|University Hospital, OR|
720692|NCT02523235||3 subjects were enrolled (signed ICF), but were not included in the results: (1) two found to have inferior visualization of the distal location and therefore excluded before randomization per protocol and (2) one subject randomized to the proximal location experienced an intraoperative medical complication unrelated to the study and was withdrawn
720697|NCT02522624|Recruitment occurred between 10/2015 - 1/2016 via community events, online advertisements, social service organizations, and the recruitment/retention arm of our Center for Community-Engaged Research.|482 participants were assessed for eligibility. Participants were excluded (n=154) if they did not meet the inclusion criteria (n=82) or could not be reached (n=65).
720698|NCT02522481||
720699|NCT02522442|A total of 51 patients completing clinical polysomnography (PSG) with CPAP was assessed for study eligibility and consented to study participation across 3 study sites.|3 participants aborted their PSG during titration and were not considered for randomization into this trial. They were not included in the baseline demographic analysis.
720700|NCT02522403||
720701|NCT02522377|Patients with TRD who are admitted to the inpatient psychiatric to receive an acute series of ECT will randomly be assigned to one of the study arms.|15 patients with TRD, who were referred to the Cleveland Clinic outpatient depression clinic or ECT service, were recruited in the study. 3 subjects were lost prior to randomization. 2 subjects were lost to follow up after the screening visit, and 1 subject withdrew consent after the baseline visit.12 patients were included in the final analysis.
720702|NCT02522325||Thirty subjects were enrolled, but one was removed from the study due to an adverse event, leading to 29 completers.
720703|NCT02522299|A total 44 participants with Chronic obstructive pulmonary disease (COPD) were enrolled in this study. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA.but the 2 treatment arms remained the same i.e. Placebo and GSK2269557 (Nemiralisib [NEMI]).There was no intent to compare two devices.|As the switch to the ELLIPTA device was intended to be a comparable treatment, the treatment groups Placebo DISKUS and Placebo ELLIPTA were combined as All Placebo treatment group. Similarly, the treatment groups NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group.
720704|NCT02522286|From May 2014 to April 2015, 75 patients were screened and enrolled for each of the 4 participating family or internal medicine clinics. Researchers met with interested patients who had a regularly scheduled appointment in order to consent and advise on how to use the study materials. After their visit, they completed a post-visit survey.|New patients and patients with physical exams or osteopathic evaluations were initially excluded though later allowed for recruitment for some physicians at one of the participating clinics. There were 6 patients who consented to participate but did not complete the final survey when exiting their appointment.
720705|NCT02521974||
720706|NCT02521948||
720707|NCT02521792|Fibrodysplasia Ossificans Progressiva (FOP) subjects treated with palovarotene for 2 flare-ups in Study PVO-1A-202/Part A were enrolled. During enrolment, the dosage regimen for Study PVO-1A-202/Part B was optimized. Study PVO-1A-203 was terminated and participating subjects enrolled into Study PVO-1A-202/Part B to receive the modified regimen.|The screening visit for this study (PVO-1A-203) was the same day as the end of study visit for Study PVO-1A-202/Part A. Subjects experiencing an eligible flare-up received open-label palovarotene (treatment period of at least 6 weeks). Subjects were to be followed for 36 months with telephone/video-conferencing assessments performed every 6 months.
720708|NCT02521766|Subjects were recruited from 3 investigational sites located in the Philippines (2) and New Zealand (1).|Of the 217 enrolled, 101 subjects did exit the study prior to implantation, and 2 subjects failed implantation of Harmoni Modular Intraocular Lens (HMIOL). This reporting group includes all subjects with successful HMIOL implantation (114) by subgroup (Cohort 1 and Cohort 2).
720709|NCT02521376|Participants were enrolled at study sites in United States, New Zealand, and Germany. The first participant was screened on 16 November 2015. The last study visit occurred on 25 October 2017.|102 participants were screened.
720710|NCT02521259||
720711|NCT02521181|Patients were recruited from the CKD medical clinic patients of the recruiting centers.|
720712|NCT02520726||
720713|NCT02520531||
720714|NCT02520518||
720715|NCT02520414||
720716|NCT02520388|The study was conducted at 22 sites in the United States. First subject enrolled was on 13 August, 2015 and last subject completed was on 13 May, 2016.|In total, 163 particpants were enrolled in the study (completed the Baseline Visit).
720717|NCT02520310|A total of 30 subjects were enrolled at 6 japan sites from September 7, 2015 to June 14, 2016.|Prior to the procedure,subjects were assessed to ensure there was no significant change in the subject's overall condition (e.g.stroke,MI,active infection,etc.) that would preclude treatment. If the subject experienced any significant change, the subject was treated&reassessed for the clinical investigation.They were not considered registered.
720718|NCT02520297||
720719|NCT02520284|Participants were enrolled at study sites in South Africa, Europe, North America, and Asia Pacific. The first participant was screened on 15 September 2015. The last study visit occurred on 22 November 2016.|241 participants were screened.
720720|NCT02520089||
720721|NCT02519855||A total of 901 participants were screened and 882 were randomized to one of two vaccination groups.
720722|NCT02519842|Eligible participants for chemotherapy Cycles 1-6 were 0-17 years old and had documented malignancies and were scheduled to receive chemotherapeutic agent(s) associated with moderate or high risk of emetogenicity. Participants entering Cycles 2-6 must have completed Cycle 1 and had no unresolved drug-related adverse events.|Participants received double-blinded fosaprepitant+ondansetron with/without dexamethasone OR placebo + ondansetron with/without dexamethasone in Cycle 1. Upon completion of Cycle 1, participants from both Cycle 1 arms had the option to continue for 5 cycles of open-label fosaprepitant + 5-hydroxytryptamine 3 antagonist with/without dexamethasone.
720723|NCT02519712||
720724|NCT02519621||93 were consented but 3 of them did not have the vac/treatment, so therefore 90 total (30 in each group).
720725|NCT02519595|Conducted at a level 1 trauma Pediatric Emergency Department from July 1st 2010 to August 31st 2012. We enrolled a convenience sample of eligible patients. Study participants were identified using the electronic medical tracking board which lists the presenting complaint and after need for IV ketamine sedation was established with physician.|11 consented patients were excluded as sedation and procedure was performed in the operating room rather than in the Emergency Department
720766|NCT02516098||All subjects were screened for eligibility to participate in the trial. Subjects who meet the inclusion criteria will be considered eligible to participate in the study. Subjects who meet one or more of the exclusion criteria will not be considered eligible to participate in the study.
720726|NCT02519504|Families were recruited through collaboration with state new born screening programs or metabolic clinics. Those expressing interest were evaluated for eligibility and asked to complete an online survey.|Interest in participating was expressed by parents or caregivers for 600 children. Consent to participate was not given for 22 and consent was given for another 12 but the initial online survey was not completed.The case/control status and demographic information is unknown for these 34 children.
720727|NCT02519387||
720728|NCT02519244||11 were enrolled; however, one person did not initiate the intervention because they were scheduled for knee surgery.
720729|NCT02519231|Between February 2016 to May 2017, 34 women enrolled into the study, of whom 28 were randomized.|Subjects who completed the baseline questionnaires were contacted 4-5 weeks later to determine eligibility for randomization to a treatment arm. Participants were eligible to be randomized if they reported any change in menstrual bleeding since their TuC380A insertion, were willing to forgo NSAIDs, and willing to record their daily bleeding.
720730|NCT02519036|46 participants were enrolled in the United Kingdom, Canada and Germany.|
720731|NCT02519023||
720732|NCT02518997||
720733|NCT02518971||176 subjects were enrolled in the study. 174 were randomized to either the active tamsulosin group or placebo group and 2 subjects were withdrawn prior to randomization. 43 additional patients were withdrawn after randomization.
720734|NCT02518919||Patients were screened for eligibility using electronic medical records and if eligible were approached by the study Research Assistant(RA) for informed consent. If the parent/guardian refused participation, were non- English speaking and if parent/legal guardian was not present to complete the informed consent process they were excluded from study
720735|NCT02518750|3 patients were recruited between Nov. 2016 and Jan. 2018|
720736|NCT02518685||
720737|NCT02518620|A total of 406 subjects was enrolled at 56 sites located in Europe (48 sites, 333 subjects) and Latin America (8 sites, 73 subjects). Consent was obtained from the first subject on 13 July 2015; the last subject completed the final visit on 23 August 2018.|A total of 472 subjects completed the entire treatment and assessment period of the preceding Phase IIb studies (placebo and ALX-0061 treatment arms only). Of these, 406 subjects were enrolled in this study. All screened subjects were included in the Intent-to-observe (ITO) Population. Overall, 405 subjects were included in the Safety Population.
720738|NCT02518490||
720739|NCT02518464|Study subjects were recruited from the hospital-based cardiology and headache clinics at Columbia University Medical Center and through the private offices of the study physicians. All subjects were evaluated by a Neurologist and fulfilled MHA criteria of the International Classification of Headache Disorders (ICHD - 3 Beta).|
720740|NCT02518139||
720741|NCT02518113||Study completers are those participants that completed Part A cycle 1 or experienced a DLT. There were no participants enrolled to Part B and Phase 2 of the study.
720742|NCT02518048||
720743|NCT02517996|Patients for this study are recruited either directly from the clinic of a Urogyn attending, or are identified the week before surgery on the OR schedule. The patients eligible for this study need to be posted for cystoscopy with hydrodistention for a diagnosis of bladder pain.|1 woman was unmasked after her initial postoperative scores were collected because of postoperative symptoms.
720744|NCT02517905||
720745|NCT02517866|Participants took part in the study at 34 investigative sites in Hong Kong, Taiwan and Thailand from 13 July 2015 to 25 November 2016.|Participants with a diagnosis of essential hypertension and type 2 diabetes mellitus (T2DM) were enrolled to receive azilsartan medoxomil at a starting dose of 40 mg increased to 80 mg if blood pressure of <140/85 mmHg was not achieved at Week 6.
720746|NCT02517658||
720747|NCT02517580||
720748|NCT02517567|Subjects were recruited from 1 study center located in Australia.|Of the 37 enrolled, 7 subjects were exited as screen failures prior to randomization and 1 subject discontinued after randomization prior to exposure to the investigational product. This reporting group includes all randomized and exposed subjects (29).
720749|NCT02517541||
720750|NCT02517528||
720751|NCT02517515||
720752|NCT02517463|700 women were recruited at a community family planning clinic of the Family Plannng Association of Hong Kong, Hong Kong, between May 2011 and March 2014|
720753|NCT02517268|22 participants were not included in the final analysis as they were not randomized to either arm of the study. Prior to randomization, 3 participants withdrew consent, and 19 participants did not undergo their procedure at Thomas Jefferson University Hospital|22 participants were not included in the final analysis as they were not randomized to either arm of the study. Prior to randomization, 3 participants withdrew consent, and 19 participants did not undergo their procedure at Thomas Jefferson University Hospital. On the control arm, 1 participant withdrew consent after randomization
720754|NCT02517047||
720755|NCT02517021||
720756|NCT02516982|Phase 1: Scrolling vs Paging layouts - Recruitment dates: October 2015 to May 2016 Phase 2: Momentary vs Momentary plus Retrospective - Recruitment dates: April 2017 tp August 2017|
720757|NCT02516605||This study comprised of an escalating multiple dose design in PBC patients with incomplete biochemical response to, but still taking, ursodeoxycholic acid (UDCA).
720758|NCT02516592|A total of 502 patients were randomized, of which 498 patients were included in the Full Analysis Set (FAS)|
720759|NCT02516579||
720760|NCT02516410|The study was conducted across 38 sites in 7 countries.|A total of 168 participants were randomized and treated in the study.
720761|NCT02516306||
720762|NCT02516228|Recruitment and treatment procedures were conducted in the Neurology clinic at Harborview Hospital. Six subjects were screened and enrolled from 12-02-15 to 04-28-17.|
720763|NCT02516202||
720764|NCT02516163||55 knees enrolled - 3 censored from analysis due to major protocol deviations = 52 knees in study analysis.
720765|NCT02516150||26 subjects were enrolled. 8 subjects were ineligible to participate, 1 subject withdrew consent, and 2 subjects were not able to be scheduled to participate. 15 subjects participated in both visits.
720955|NCT02499120||A total of 125 participants were randomized; among them, 124 participants received study treatments. One (1) participant in the palbociclib + cetuximab treatment group was randomized but not treated. Data reported is based on the primary analysis date of 19 July 2018.
720767|NCT02516046|Enrollment occurred between October 2015 and June 2018. Enrolled end-of-life subjects (life expectancy less than 6 months) at hospice centers in the US and Australia consented to a flortaucipir PET scan and to brain donation at autopsy.|To be considered eligible for the primary analysis, death had to occur within 9 months of flortaucipir scan and valid autopsy was required. The first 3 subjects to come to autopsy were considered front-runners. Front-runner scan and autopsy results were unblinded to the sponsor to optimize analysis.
720768|NCT02515994||A total of 224 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 221 were dispensed a study lens. Of the dispensed subjects 204 completed the study while 17 subjects were discontinued.
720769|NCT02515942|Subjects were recruited from 28 sites in the US and Puerto Rico.|This reporting group includes all randomized participants.
720770|NCT02515890||
720771|NCT02515851||
720772|NCT02515669|Doses for this study are based upon achieving a moderate to high degree of suppression in serum free myostatin at steady-state trough across 3 dose levels. A body weight-tiered, fixed-dose strategy targeting moderate (>50%), high (>85%) and near complete (>95%) suppression of serum free myostatin was used to select the three doses for the study.|Starting at Week 5, participants whose weight exceeded or dropped below the dosing weight tier to which they were assigned (by >1kg) were assigned to the new corresponding body weight-based dose within the participants assigned panel.
720773|NCT02515656||3 patients who signed an Informed Consent Form (ICF) were screen failed and were not randomized in the study.
720774|NCT02515331||Participants were randomized in a 1:1:2 ratio to LHW090 100 mg, LHW090 200 mg and placebo, respectively.
720775|NCT02515305||
720776|NCT02515279||
720777|NCT02515253||
720778|NCT02515097||
720779|NCT02515058||After enrollment, one subject was withdrawn as a screen failure. This left a total of 43 subjects enrolled to take part in the study
720780|NCT02515045|Study recruitment started on December 2014 and ended in March 2016. Potential subjects were identified from the patients presenting at the clinics for eye evaluation.|No significant events in the study occurred after participant enrollment, but prior to randomization.
720781|NCT02514889|All adult patients in waiting room of two clinics were approached for assessment of eligibility to enroll in the trial. The eligibility assessment period began 4/1/2015 and ended on 2/5/2016. 2,086 patients were approached; screening was completed for 1,889. Of these 1,889, 1,628 were found to be ineligible, leaving 261 to be randomized.|All participants who were enrolled were randomized.
720782|NCT02514824|Participants enrolled from October 2015 through March 2017.|
720783|NCT02514772||
720784|NCT02514746|"This study enrolled Bangladeshi children who had participated in Study JEV05 (NCT01567865) and received a single dose of live attenuated Japanese encephalitis vaccine (CD-JEV).
~The first visit in this study was 3 years after vaccination in JEV05. At the 2nd study visit, 4 years after initial vaccination, children received a booster dose of CD-JEV."|"Children were analyzed based on whether they received vaccine from the new or old facility in Study JEV05:
~Group A: Received CD-JEV from new facility in Study JEV05
~Group B: Received CD-JEV from old facility in Study JEV05"
720785|NCT02514577||
720786|NCT02514551||Completers are defined as participants who died or had progressive disease (PD) or completed treatment or did not complete treatment and were followed for survival data. Final study data will be provided after study completion.
720787|NCT02514473||A total of 206 participants were randomized in the study, of which 204 participants were exposed to study treatment (101 participants received 'Placebo' and 103 participants received '(lumacaftor [LUM] / ivacaftor [IVA])'.
720788|NCT02514174|Open-label, non-randomized, Phase IV, single arm study|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
720789|NCT02514122||
720790|NCT02514083||
720791|NCT02514070|44 participants enrolled on protocol. 5 of these 44 participants were considered screen failures. 39 participants started the protocol.|
720792|NCT02514044||
720793|NCT02513940|"Recruitment began in July 2015; procedures were completed on last enrolled subject in October 2017.
~Subjects were recruited from advertisements placed in a seniors magazine, assisted living facilities, and local health fairs."|n=77 subjects initially assessed for eligibility; n=16 declined to participate, n= 49 excluded (met one or more exclusion criteria); n=22 provided written informed consent (these participants were not considered to be enrolled); n= 8 excluded after providing consent because they were found to meet an exclusion criterion
720794|NCT02513823||
720795|NCT02513771|First participant was enrolled on October 20, 2015. Accrual to the study closed on August 24, 2016, with 15 U.S sites registered and enrolled participants.|Participants were randomized 1:1 to Sitagliptin and Placebo arms. Randomization was stratified by screening CD4 (100-350 vs >350 cells/mm^3) and statin use.
720796|NCT02513745||A total of 84 eyes of 42 patients were enrolled and started the study.
720797|NCT02513732|A total of 100 subjects were enrolled from multiple sites.|
720798|NCT02513719|A total of 312 subjects were enrolled from 30 sites. The enrollment period was from May 13, 2013 to March 25, 2014.|
720799|NCT02513641||
720800|NCT02513550||
720801|NCT02513498||
720802|NCT02513472|Participants took part in the study at 18 investigative sites in the United States. Results are reported in this result summary at primary completion date (31 July 2019). A total 258 participants were screened and enrolled, of which 91 were screen failures and 167 were treated. RP2D is recommended Phase 2 dose.|As planned, data is reported based on Stratum 1 (No prior treatment with systemic anticancer therapy) and 2 (prior 1 to 2 lines of systemic anticancer therapy) due to better estimating efficacy data for Stratum 2. All participants enrolled in Phase 1b and treated on RP2D level were pooled with the participants in Phase 2 for efficacy analysis.
720803|NCT02513459||All enrolled participants
720804|NCT02513446||An open-label, randomised, two-period, two-sequence crossover study with healthy male subjects
720805|NCT02513212||
720956|NCT02499029|Participants were recruited from the VA medical center between March 2013 and April 2014.|
720806|NCT02513160|A total of 1089 patients with asthma were screened for enrollment into this study at 67 study centers in the US.|"Of the screened patients, 376 patients were not enrolled; 312 were excluded on the basis of inclusion/exclusion criteria, 19 patients withdrew consent, 10 patients were lost to follow-up before the baseline visit, 1 patient reported an adverse event before entering run-in and the reason for screen failure was Other for 34 patients."
720807|NCT02513121|Children with NAFLD were recruited from two US academic clinical research centers (University of California, San Diego and Emory University)|Boys ages 11 - 16 with biopsy proven NAFLD were randomized
720808|NCT02513095||
720809|NCT02512900|Adolescent participants (12 to 17 years, inclusive) with mild to moderate asthma were recruited in an open-label fashion to receive a single-dose of MEDI9929 (also known as tezepelumab or AMG 157) at two study centers in Poland from Sep 2015 to May 2016.|A total of 26 participants were screened, out of these, 21 subjects were randomized and completed the study at 2 investigative sites in Poland.
720810|NCT02512874||
720811|NCT02512861||
720812|NCT02512809||"There were no participants assigned to the Isoflurane and Dexmedetomidine/Remifentanil Arm Arms/Groups as only the MRI control arm completed enrollment prior to the original PI leaving the institution and there was no enrollment in the other 2 arms."
720813|NCT02512783||
720814|NCT02512679|Patients for bone marrow transplantation who met the eligibility criteria of diagnosis and clinical status and had histocompatible sibling donor. These patients were recruited at Children's Hospital Los Angeles and Lucille Packard Children's Hospital at Stanford University. Patients were recruited between 2006 and 2013.|This is a sequential dose de-escalation of Cyclophosphamide with first at 105 mg/kg total dose compared to standard 200mg/kg total dose (Arm 1). Prior to enrollment patients had to meet all eligibility criteria for allogeneic transplantation. Study closed after 1st level because all patients engrafted and none had toxicity related to transplant.
720815|NCT02512575|Phase 1, single-center (Berlin), randomized, single-blind, placebo-controlled study carried on 72 healthy male participants (8 subjects per cohort). In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2). Participants received treatment in a fasted state|Screening period (Day -28 to Day -3). For Cohort 7, screening period was up to 21 days
720816|NCT02512510||
720817|NCT02512419||
720818|NCT02512393||
720819|NCT02512302||Eligible subjects will be randomized to one of 10 treatment sequences. There will be a minimum of a 7-day washout period between each treatment visit. At each visit, subjects will receive one dose of study medication according to the sequence assigned.
720820|NCT02512276||
720821|NCT02512224||
720822|NCT02512094||
720823|NCT02512068|Participants took part in the study at 41 investigative sites in Japan, from 7 August 2015 to 24 April 2018.|Participants with a historical diagnosis of type 2 diabetes mellitus complicated by severe renal impairment or end stage renal disease (ESRD) were enrolled in one of the two treatment groups: trelagliptin 25 milligram (mg) throughout Period I and II, Placebo in Period I followed by trelagliptin 25 mg in Period II.
720824|NCT02512042||The populations for this study included the Randomized Population, Safety Population and Per Protocol Population.
720825|NCT02511782||
720826|NCT02511730|The 100 breast screening and diagnostic cases selected for this study, were obtained from the FMSU2013-004A acquisition study. The statistician randomly selected cases to provide a distribution of density, finding types, etc.|Each radiologist read all 100 cases as FFDM only and FFDM+DBT(100 cases multiplied by 2 modalities = 200 reads) with a 4 week washout period between the 2 sessions.
720827|NCT02511717||
720828|NCT02511678||Discontinuation reasons reported below of death, withdrew consent, oncologist cancelled study cryoablation, required radiofrequency ablation, negative biopsy, protocol violation, and received radiation treatment include 7 enrolled participants who were discontinued before treatment was attempted. No other data is reported for these 7 participants.
720829|NCT02511587||
720830|NCT02511561||
720831|NCT02511535||
720832|NCT02511431||Enrollment number in the Protocol Section (22) conflicts with the number of participants started (21). One enrolled patient declined participation prior to randomization.
720833|NCT02511379|Participants were enrolled from 4 study sites located in India.|
720834|NCT02511184||
720835|NCT02510820||Three subjects were not dispensed the combination of multipurpose solutions.
720836|NCT02510664|Recruited from diabetes clinics at Texas Children's Hospital|Of 172 individuals (84 parents, 84 adolescents, 4 providers) consented, n=40 (20 parent-adolescent dyads) did not receive the intervention: 18 (9 dyads) transferred care to a provider not trained in intervention, 20 (10 dyads) because their provider retired & insufficient time to reschedule in study period, 2 (1 dyad) due to time constraints
720837|NCT02510144||
720838|NCT02510014||A total of 994 subjects were screened by 39 sites, and of those, 775 subjects entered the run-in period receiving at least 1 dose of SUBOXONE (508 de novo subjects and 267 roll-over subjects).
720839|NCT02509936||
720840|NCT02509767||
720841|NCT02509585||
720842|NCT02509481|2712 participants from 8 villages were recruited to participate and enrolled. Importantly, the intervention (repeated ivermectin MDA) was given to most villagers and the safety outcome was assessed in this whole group. However, the primary outcome was assessed in a cohort of 590 enrolled village children ≤5 years old.|
720843|NCT02509156|Enrollment took place at seven CCTRN centers between September 2016 and October 2018. The main centers are located in Texas, Florida (2 locations), Minnesota, Kentucky, Indiana, and California. Recruitment methods included www.clinicaltrials.gov, cancer survivorship organization websites, and local cancer center physician outreach.|46 subjects consented to participate; 37 completed baseline testing and met eligibility criteria. This includes 6 (open label) and 31 (randomized) subjects. Reasons for failed eligibility (n=9) include elevated LVEF, failure to complete baseline testing, MRI contraindications, and investigator discretion.
720844|NCT02509117||Study conducted in 3 parts: Part A (4-period cross-over design), Part B and C (single period, parallel design).
720845|NCT02509078||
720957|NCT02498834||
734490|NCT01500213||
720846|NCT02509065|27 subjects were recruited and found eligible. Of the 27, only 24 subjects participated in the trial.|There were 24 subjects and a total of 9 study arms.The order of the arms was assigned in a psuedo random cross-over design. The 110 and 120 mg/dl arms were added later and were not included in the original randomization. 11 of the same subjects completed all 9 arms. Each arm had 20 subjects total, but these 20 were not the same cohort in each arm.
720847|NCT02509026||The first visit of the Period 3 (re-treatment period) might occur at the same time as a regularly scheduled visit during Period 2 (withdrawal period) or as an unscheduled visit for a participant who experienced flare during Period 2.
720848|NCT02508935|The study was conducted from November 20, 2015 to April 26, 2017 and enrolled participants from the United States.|
720849|NCT02508701||
720850|NCT02508480||
720851|NCT02508428|Beginning in January of 1999 and continuing over an 18-month period, patients at our institution were enrolled in a prospective, randomized, Institutional Review Board approved study to compare the outcome of THA using XLPE or CPE liners.|All patients undergoing primary THA were eligible to participate in this study. A total of 226 patients (236 hips) consented to participate. Six patients (6 hips) were excluded at the time of their surgery because they were not implanted with the study components for reasons related to intra-operative hip stability.
720852|NCT02508259||
720853|NCT02508207||
720854|NCT02508194|A total of 1900 participants were randomized and participated in the study at 60 sites in 7 countries.|A total of 2,044 participants were screened, of which 144 participants were screen failures and 1900 participants were randomized in the study.
720855|NCT02508116|Patients, age ≥18 to ≤80 years at time of study, who were underwent PCI between November 2014 and August 2016 at the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center.|
720856|NCT02508103||
720857|NCT02508077||
720858|NCT02507973|200 patients were screened for eligibility between July 2015 and April 2018 at University of Maryland, Baltimore.|8 of 200 patients were randomized. The other patients were excluded as they did not meet the eligibility criteria.
720859|NCT02507752|A total of 95 participants were screened for eligibility between July 2009 and December 2011 at 16 centers in Brazil.|Out of 95 participants, 72 who answered at least one short form 36 (SF-36) questionnaire made up the Intent-to-treat (ITT) population
720860|NCT02507388|Subjects were recruited from 5 study centers in Japan and 2 study centers in the United States.|This reporting group includes all subjects who signed an informed consent form and were assigned an identification number (51), minus one subject exited as a screen failure prior to treatment initiation.
720861|NCT02507375|Seventeen patients enrolled in 3 centers. Three patients from cohort 1 and 1 patient from cohort 2 completed the 6 cycles of study therapy, as planned.|Two participants in cohort 2 did not begin experimental study drug treatment in Cycle 1, so were not included in the analysis set.The resulting participant flow includes only participants who received pertuzumab.
720862|NCT02507349||
720863|NCT02507219|24 participants were recruited for the study at the Laureate Institute for Brain Research in Tulsa, Oklahoma.|22 of 24 participants who signed informed consent were randomized. 2 participants withdrew from the study prior to randomization due to work schedule and no response to scheduling attempts.
720864|NCT02507011||
720865|NCT02506985||
720866|NCT02506881||
720867|NCT02506868||
720868|NCT02506816||"Out of 49 patients initially considered for study eligibility, 9 did not sign the ICF and 4 did not meet eligibility criteria (screen failures).
~Out of 36 patients who were treated and included in the overall analysis and safety, 5 were excluded from the primary and secondary analysis because of no valid samples for biomarker characterization."
720869|NCT02506673||
720870|NCT02506660||
720871|NCT02506634|Four hundred consecutive patients with upper gastrointestinal (GI) symptoms were screened, 19 patients who didn't meet the inclusion criteria and 7 patients with major motility disorders on high resolution manometry were excluded. Thus, a total of 374 patients were finally enrolled in the current study.|The current study was a single Arm study where all participants with upper GI symptoms were enrolled and tested for gastro-esophageal reflux disease (GERD) via endoscopy and 24-hour reflux monitoring. Participants were then given proton pump inhibitor(PPI) treatment and the course was decided base on the endoscopy findings.
720872|NCT02506309||
720873|NCT02506257||
720874|NCT02506101||
720875|NCT02506036||
720876|NCT02505945|Subjects were enrolled at 21 US clinical sites between July 2015 and February 2017|
720877|NCT02505919||
720878|NCT02505867||
720879|NCT02505542|The study started to enroll patients in July 2015 and concluded in April 2019.|"The study included 2 parts: Part A with a Screening Period (up to 5 Weeks) and an Open-Label Period (Week 0 to Week 48) and Part B with a Double-Blind Period (Week 48 to Week 96) and a Safety Follow-Up Period (10 weeks after the last dose of study medication).
~Participant Flow refers to the Open-Label Set."
720880|NCT02505334|The trial was conducted at 47 sites in Japan: 47 sites screened and 45 of them randomised subjects. After screening, 635 subjects entered into the 12-week run-in period.|Subjects received liraglutide 0.9 mg/day (starting with 0.3 mg/day with subsequent weekly dose escalation of 0.3 mg to a maximum 0.9 mg/day) during 12 weeks run-in period. Subjects with HbA1c ≥7.0% at the end of run-in period were randomised (1:1) to two treatment arms: continuing liraglutide 0.9 mg/day or dose escalation to liraglutide 1.8 mg/day.
720881|NCT02505269||
720882|NCT02505217||
720883|NCT02504931||
720884|NCT02504892||The Sporadic chromophobe renal tumors arm/group is not included here and throughout because the protocol was amended to remove the Sporadic chromophobe renal tumors arm/group. The study was unable to enroll participants with this disease.
720885|NCT02504827||
720886|NCT02504775|Recruitment was done in one center in Mexico.|Fifty two participants were screened for this study, out of which 15 participants were considered screening failure, 9 were kept as backup and 28 participants were randomized and all 28 of them completed the study.
720887|NCT02504723||
720990|NCT02495844|Enrollment started in August 2015 and concluded in July 2017.|Participant Flow refers to the Randomized Set.
734699|NCT01485991||
720888|NCT02504671|This study was conducted at a total of 60 sites in 12 countries: Ukraine (11), Poland (10), Russian Federation (10), Mexico (6), Czech Republic (5), Bulgaria (4), South Africa (3), Hungary (3), Estonia (2), Canada (2), United Kingdom (2), and Germany (2) from 23-July-2015 until 29-December-2017.|A total of 526 participants were screened of which 304 were screen failures and 222 participants were enrolled in the study.
720889|NCT02504645||200 patients were planned to be enrolled and treated. At the end, 202 were treated.
720890|NCT02504619||
720891|NCT02504554||
720892|NCT02504541|133 patients were enrolled in this study. 113 (85.0%) patients completed the study (through the Follow-up Visit) and 20 (15.0%) patients prematurely withdrew from the study.|Although 21 sites participated in the study, only 19 sites enrolled patients in the United States. This study was intended to collect additional safety and exposure data, to ensure compliance and accuracy.
720893|NCT02504502|Subjects participating in the whole genome sequencing study for undiagnosed developmental delay at Geisinger Health System were invited to participate.|"parents were randomized together (e.g. parents were both randomized to the same arm).
~parents were grouped by genomic sequencing finding (causal variant found vs. non-causal variant found) prior to randomization to ensure equal number of causal variants and non-causal variants in each arm."
720894|NCT02504424|This study recruited women who were planning to have immediate or delayed breast reconstruction (unilateral or bilateral) post-mastectomy and required tissue expansion to develop tissue coverage for placement of standard breast implant(s). Subjects were identified from the medical practice of the participating investigators.|
720895|NCT02504320|Participants took part in the study at 1 investigative site in the United States from 29 June 2015 to 01 October 2015.|Healthy participants were enrolled equally in 1 of 4 sequences which determined order of treatment: Regimen A (Febuxostat extended release [XR] 80 mg capsule [cap] Formulation [F] 1), B (Febuxostat XR 80 mg cap F2), C (Febuxostat XR 80 mg cap F3) and D (Febuxostat XR 80 mg cap F4). Each regimen is separated by a 7-day washout period.
720896|NCT02504294||In this study, 432 participants were enrolled, however, only 418 participants were treated.
720897|NCT02504268||1067 participants were enrolled, 753 were randomized. Of the 753 randomized, 1 participant was randomized but not treated. Full cohort 1 analysis population which is the primary endpoint analysis population includes 752 participants
720898|NCT02504216|Study was conducted at 548 centers which screened participants (534 sites randomized participants) worldwide between 18 Aug 2015 (first patient's first visit) and 27 Nov 2019 (last patient's last visit).|A total of 6772 participants were screened, of which 6564 were randomly assigned to either of the two treatment arms.
720899|NCT02504099||
720900|NCT02504073||
720901|NCT02503982|conducted at the Schneider Children's Medical Center (SCMC) from December 2014 to August 2015.|A prospective pharmacokinetic. age <18 years of age, GFR>60 mL/min/1.73m2, solid-organ transplantation and oral VGC prophylaxis for CMV infection
720902|NCT02503865||
720903|NCT02503852||
720904|NCT02503787||All enrolled subjects will undergo a Spinal Cord Stimulation device trial that includes an intraoperative programming trial. Subjects experiencing a positive response (improvement in average overall pain relief) during the trial will move forward with a permanent implant. Those not reporting a positive response will be exited from the study.
720905|NCT02503735|14 patients were recruited and signed informed consent|
720906|NCT02503540|Recruitment occurred from within ophthalmology clinics.|Single arm study. N/A
720907|NCT02503501||Of the 49 participants who signed a consent form for the study, 12 participants screen failed and did not meet the inclusion criteria at screening, 2 participants declined to participate after the initial screening. These 14 participants were not assigned to a treatment group since they were removed from the study prior to randomization.
720908|NCT02503410|Subjects were recruited primarily among the outpatient population of individuals with low back pain at Spaulding Rehabilitation Hospital.|
720909|NCT02503332|This Phase II, randomized, single-masked, sham injection-controlled study in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) was conducted at 47 sites (46 active) in 3 countries between 24 September 2015 and 14 July 2017 (Data cut-off date, Month 12).|Subjects were randomized in a 2:2:1:1 manner to receive treatment with pegcetacoplan monthly, pegcetacoplan every-other-month (EOM), sham monthly or sham EOM, respectively. A total of 246 subjects were randomized in the study.
720910|NCT02503254|"Study initiated (first subject screened): 04 July 2015
~At admission (Day -3), all the subjects performed a product trial of the CHTP 1.0. During the baseline period, they continued smoking their single preferred brand of CC. Then, on Day -1, subjects were randomized to one of the two study arms (CHTP 1.0 or CC) in a 1:1 ratio."|"Enrolled and randomized population = 80 subjects
~41 subjects in CHTP 1.0 arm
~39 subjects in CC arm
~Number of subjects enrolled but NOT randomized (who tried the CHTP 1.0 at Day -3) = 5"
720911|NCT02503215|"Patients were screened for sleep apnea from August to October 2014. Screening consisted of applying the Berlin Questionnaire. Patients at risk for sleep-disordered breathing were then submitted to polysomnography in order to confirm obstructive sleep apnea.
~Patients with apnea/hypopnea index > 5 were recruited."|Patients who did not have obstructive sleep apnea at the initial polysomnography evaluation were excluded from study. Additionally, patients who were unable to wear compression stockings or use positive airway pressure after enrollment were also excluded from study
720912|NCT02503202||A total of 1261 participants were screened and 1197 were randomized.
720913|NCT02503085||Total 60 subjects were screened and among them 16 subjects were screen failure, 2 subjects withdrew consent and 14 subjects were reserve.
720914|NCT02502864|Participants were enrolled at Moffitt Cancer Center, February 2016 through June 2017.|
720915|NCT02502734|Study consisted of run-in period of two-weeks followed by two treatment periods of 14 days each (+/- 4 days) separated by a 14-day washout period and a follow-up visit of approximately 7 days post last dose. The total participation time in the study was approximately 9 Weeks.|A total of 60 participants were randomized to receive one of the two treatment sequences; placebo followed by inhaled fluticasone furoate or inhaled fluticasone furoate followed by placebo. All 60 participants received at least one single dose of study medication.
721062|NCT02489500||
721063|NCT02489357||
721540|NCT02446691|Subjects were enrolled from 6 centers in South Korea.|All enrolled subjects were vaccinated.
720916|NCT02502526|Subjects were recruited from 4 study centers located in the United States (2), Hungary (1), and India (1).|Of the 231 subjects enrolled, 49 were exited prior to randomization (34 due to randomization suspension, 14 due to screen failure, and 1 due to subject death). This reporting group includes all randomized subjects (182).
720917|NCT02502487||
720918|NCT02502461||
720919|NCT02502149||
720920|NCT02502071||
720921|NCT02502019||
720922|NCT02501928|This (A0221109) was a long term extension (LTE) study only among Japanese participants who participated and completed the precedent study A0221047 (NCT01557244). Per plan, efficacy outcome measures and treatment-emergent adverse events were reported using merged data of studies A0221047 and A0221109.|A0221047 had 2 cohorts. Cohort 1 had an active comparator phase and Cohort 2 had an efficacy phase followed by a safety extension phase for each cohort. Japanese participants from both cohorts, if consented continued in this LTE study and received the same treatment as in A0221047, per investigator judgment on safety and tolerance of participants.
720923|NCT02501759||
720924|NCT02501629||A total of 273 patients with OCS-dependent severe eosinophilic asthma were screened, and 180 of these patients (at 78 centers) were considered eligible for enrollment. Three of the eligible patients were not randomized due to failure to meet randomization criteria.
720925|NCT02501590||
720926|NCT02501538||
720927|NCT02501473|Participants were enrolled in the study at clinical sites in the United States and Europe.|Part 5, G100 plus Rituximab, Dose Escalation: 12 to 24 participants were planned; no participant was enrolled or dosed.
720928|NCT02501161|The trial was conducted at 130 sites in Argentina (4),Czech Republic (4), Hungary (5), India (11), Israel (8), Italy (7), Mexico (4), Norway (7), Poland (3), Russian Federation (8), Slovakia (5), South Africa (10), Turkey (8), United Kingdom (9) and United States (37).|Participants were randomised in a 1:1 manner to receive either IDegLira or IGlar as an adjunct to oral anti-diabetic drugs (OADs). OADs allowed were: biguanides, sulphonylurea (SU), glinides, pioglitazone, and dipeptidyl peptidase-4 inhibitors (DPP4-inhibitors), though glinides and DPP4-inhibitors were not allowed as monotherapy or in combination.
720929|NCT02501135||
720930|NCT02500979|The first subject was enrolled in the study (at Visit 2) on 27 August 2015. A total of 79 subjects were screened and 34 subjects were randomized at 3 sites in the United States. One additional subject was randomized in error and was discontinued prior to receiving any study medication. The last subject completed the study on 05 August 2016.|Eligible study subjects were males and females, aged ≥18 years and ≤70 years at the time of screening with a prior diagnosis of type 1 diabetes mellitus (T1DM) and an HbA1c value of ≥7.2% and ≤9.0% at screening.
720931|NCT02500901||
720932|NCT02500836|Subjects were recruited from patients scheduled for an office-based or operating room-based diagnostic procedure or surgery on or through accessible mucous membranes of the nasal cavities.|A screening visit was conducted to ensure that each subject met inclusion/exclusion criteria for the study. Subjects who met all eligibility criteria were then enrolled for the drug application and procedure visit, which may have been on the same day as the screening visit.
720933|NCT02500797||GIST Cohort: 24 patients assessed for eligibility; 3 excluded (i.e. ineligible) and 21 randomized.> LPS Cohort: 37 patients assessed for eligibility; 11 excluded, 3 included (2 pre-registered as UPS/MFH cohort, 1 pre-registered as GIST cohort) and 29 randomized.> UPS/MFH Cohort: 47 patients assessed for eligibility; 18 excluded and 29 randomized.
720934|NCT02500758|The recruitment process started in june 2015 and ended in august 2015, involving 20 healthy adult volunteers, who were recruited in Nursing, Physiotherapy and Podiatry School of Complutense University of Madrid.|The volunteers are randomly divided into two groups of the same size, by tossing a coin.
720935|NCT02500732||
720936|NCT02500706|The trial was conducted at 146 sites in 12 countries(number of sites indicates those that both screened and randomised subjects, unless otherwise noted)-Austria(4);Bulgaria(8); Canada(6); Germany(7); India(16); Israel(6); Italy(4); Japan(24); Russian Federation(10); Serbia(3); Taiwan(3); United States(55 sites screened/52 sites randomised subjects)|Eligible subjects were enrolled in a 8-week run-in period (1108 subjects) where subjects were switched from previous insulin treatment to insulin degludec once daily,and NovoRapid®/NovoLog® as mealtime bolus insulin. The basal insulin treatment was optimised using treat-to-target approach. 83 subjects were run-in failures and 1025 were randomised.
720937|NCT02500641||A Run-in/screening period of 1 week (extendable up to a maximum of 30 days to account for variability of serum urate levels) was present prior than randomization.
720938|NCT02500628|7/25/2015 to 2/21/16|
720939|NCT02500537||
720940|NCT02500368||One participant discontinued from the study as a screen failure before lens randomization.
720941|NCT02500056||
720942|NCT02499952||
720943|NCT02499900|A total of 876 patients with RRMS were screened for enrollment into this study. Of the 876 patients screened, 861 patients at 88 centers in Russian Federation, Poland, Italy, France, Croatia, US, Mexico, Spain, Austria, Turkey, Belgium, Argentina, Germany, Finland, & Puerto Rico met entry criteria and were considered to be eligible for enrollment.|Of the 15 patients who were not enrolled, 2 patients were excluded on the basis of inclusion criteria not met, 4 patients were excluded on the basis of exclusion criteria met, 7 patients withdrew consent, and 2 patients were lost to follow-up before the baseline visit.
720944|NCT02499887||
720945|NCT02499783||
720946|NCT02499770|The study was conducted at 71 centers in the United States of America and Europe. The first participant enrolled on 26 June 2015 and the last participant completed on 22 February 2019. For Part 1, participants were enrolled from 26 June 2015 to 30 September 2016 and for Part 2, participants were enrolled from 06 October 2016 to 25 April 2017.|Participants were screened within 14 days prior to first study drug administration. Informed consent and brain scans were obtained up to 28 days prior to first study drug administration. A total of 122 participants were enrolled (24 in Part 1 and 98 in Part 2), of which 96 were assigned to treatment.
720947|NCT02499692||
720948|NCT02499575||
720949|NCT02499406||
720950|NCT02499380||
720951|NCT02499263||There were 150 participants enrolled; 4 were not treated and hence 146 were included in the intent to treat (ITT) set.
720952|NCT02499172||
720953|NCT02499159||
720954|NCT02499146||
720958|NCT02498821|Site healthcare providers identified potential subjects referred for placement of a PICC as part of their routine care. Subjects met all eligibility criteria listed in the study protocol. Recruitment occurred between May 2015 and May 2016.|Three patients in the Standard of Care (Chest X-ray) arm and five patients in the Sherlock 3CG TCS arm were excluded from the study as screen failures following enrollment.
720959|NCT02498769||
720960|NCT02498678||
720961|NCT02498652|41 subjects were randomized.|Forty-one subjects were randomized and received at least 1 dose of randomized study medication; 20 subjects in Cohort 1 and 21 subjects in Cohort 2. Subjects were randomized into 1 of 8 sequences across the 2 cohorts (20 subjects each) in a 1:1 ratio.A total of 40 subjects completed the study.
720962|NCT02498600|The study opened to accrual on 6/29/2015 and enrolled 49 patients. It temporarily closed on 10/7/2015 and awaited data maturation until 10/4/2016. The study reopened on 5/22/2017 and closed 8/28/2017 with a cumulative accrual of 100 patients|
720963|NCT02498522||
720964|NCT02498483||
720965|NCT02498418||A total of 739 nonindigenous travelers with naturally acquired acute diarrhea were enrolled and randomized in this study.
720966|NCT02498236||
720967|NCT02498067||
720968|NCT02497976|Patients were recruited from my practice, web site, and Urology clinic at UCSD from December 10, 2015 through March 1, 2017.|There were 3 patients who did not meet screening criteria. Twenty-four patients had sufficient improvement in their IC/BPS symptoms and did not continue with the drug versus placebo phase of the study.
720969|NCT02497937|This was a randomized, double-blind, sponsor-unblinded, placebo-controlled, 2 by 2 crossover study in adults with heart failure. A total of 11 participants with Congestive Heart Failure were enrolled in the study. Study was conducted in the United States.|
720970|NCT02497781||
720971|NCT02497755|Participants were recruited from the caseload of a care manager at the UW Ravenna Neighborhood Clinic who were enrolled in the Behavioral Health Integration Program for depression and anxiety. Recruitment letters were mailed between 6/15/2015 and 7/27/2015.|
720972|NCT02497612|Study conducted at 12 active sites in 7 countries. Total of 806 participants were screened between 25 July 2015 and 22 July 2019, of which 377 were randomized to 1 of 4 treatment arms (via Integrated Web Recognition System using permuted block randomization schedules). 429 participants failed screening mainly due to meeting exclusion criteria.|In each arm, participants were divided in 4 cohorts (C):C1 (greater than [>] 14 years (yrs) to less than [<] 70 yrs); C2 (>5 yrs to less than or equal to [<=] 14 yrs );C3 (>2 yrs to <=5 yrs); C4 (>6 months to <=2 yrs). Day 0 (drug administration day, per protocol) was Day 1 for safety reporting as per Clinical Data Interchange Standards Consortium.
720973|NCT02497469|Participants took part in the study at 205 investigative sites worldwide from 29 June 2015 up to 18 January 2019.|Participants with a diagnosis of moderately to severely active ulcerative colitis (UC) were enrolled in a 1:1 ratio to receive vedolizumab or adalimumab and matching placebo.
720974|NCT02497391||Participants were randomized to 1 of 6 treatment sequences in a crossover design with 3 treatments; reference, test 1 and test 2. There was a washout period of ≥14 days between each dose. Participants were dosed 3 times during the entire study in periods 1, 2 and 3.
720975|NCT02497287|In this study participants from study ESKETINTRD3005 (NCT02422186) were enrolled (transferred entry [TE]). ESKETINTRD3005 is referred as TRD3005 in the draft.|Total 802 participants were enrolled (direct-entry [DE]=691 + TE from study ESKETINTRD3005 =111). Among 111 TE participants, 88 participants (non-responders from ESKETINTRD3005) joined induction (IND) phase and 23 participants (responders from ESKETINTRD3005) did not join IND phase and directly entered in optimization/maintenance (OP/MA) phase.
720976|NCT02497235|Participants took part in the study at 1 investigative site in the United States from 01 July 2015 to 04 January 2016.|Healthy participants received up to 370 megabecquerel (MBq) (10 millicurie [mCi]) of [18F]MNI-792 with a mass of up to 5 microgram (mcg) at baseline and were enrolled to 1 of 5 treatment groups: TAK-935 50 milligram (mg), 100 mg, 200 mg, 300 mg, and 600 mg.
720977|NCT02497040||
720978|NCT02497001|This study was conducted at 208 sites in four countries, from August 2015 until January 2018. The entire study period could take up to a maximum of 30 weeks.|Subjects were randomized in a 2:2:1:1 scheme.
720979|NCT02496884|A total of 56 participants who met all inclusion and no exclusion criteria were randomized to treatment in four countries: Bulgaria, Romania, Spain, and the United States.|Eligible participants were randomized 2:1 to receive either DS-5565 7.5 mg QD or placebo for participants with CrCl 15 to 29 mL/min, or 2:1 to receive treatment with DS-5565 7.5 mg BID or placebo for participants with CrCl 30 to 59 mL/min over a 13-week double-blind treatment period.
720980|NCT02496767|Patients with familial or sporadic amyotrophic lateral sclerosis were enrolled at 79 sites in Belgium, Canada, France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Spain, and the United States. The first patient was screened on 03 September 2015 and the last subject completed on 27 September 2017.|All enrolled patients began open-label tirasemtiv (250 mg) in a 2-week lead-in phase. Completed patients were randomized (3:2:2:2) to placebo or tirasemtiv (250, 375, or 500 mg) for 48 weeks of double-blind treatment. After which, patients on tirasemtiv were re-randomized (1:1) to placebo or tirasemtiv (current dose) for a 4-week withdrawal phase.
720981|NCT02496702||
720982|NCT02496533||
720983|NCT02496221||Eligible participants were randomized to one of the two treatments in Treatment Period 1 followed by a wash-out period and crossed over to other treatment in Treatment Period 2.
720984|NCT02496091||
720985|NCT02496039||A total of 14 participants were screened for study enrollment; however, only 5 participants were enrolled.
720986|NCT02496000||Study design: screening, followed by a 14 day wash-out followed by a 14-day single-blind run-in prior to the 28-day treatment period. Efficacy based on the Intend-to-treat population 80% trimming of the data. The safety (adverse events) data is based on the safety population.
720987|NCT02495948|Participants were recruited from 10 investigational sites located in the US.|Of the 168 enrolled, 1 participant was exited as a screen failure prior to randomization. This reporting group includes all randomized participants (167).
720988|NCT02495883||
720989|NCT02495857|The populations for this study included the Safety Population, the modified Intent-to-Treat (mITT) population, and the Per-Protocol (PP) Population.|
734811|NCT01478360||
735894|NCT01411228||
720991|NCT02495831|The recruitment started and finished on May 2015 and the study was performed in Switzerland at CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 CH-6864 Arzo, Switzerland|Twenty-four (24) subjects were randomised in the study. One of the 24 subjects discontinued the study before study treatment. Twenty-two (22) subjects completed the study per protocol.
720992|NCT02495779||
720993|NCT02495623||79 subjects were randomized into the study per IVRS. 63 subjects received at least one dose of SYN-010. 16/79 subjects were not administered a single dose of study drug or placebo. We considered the subject truly randomized once the subject had completed the breath methane test, completed the daily diary entries, and were assigned study drug.
720994|NCT02495467||
720995|NCT02495454||One case excluded for violation of inclusion criteria (transformed lymphoma)
720996|NCT02495389|Patients were recruited from January 2015 through October 2018 (46 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.|
720997|NCT02495259||
720998|NCT02495233|Participants with Epidermal growth factor receptor (EGFR) activating mutation-positive (EGFRm+) advanced NSCLC who have acquired resistance to an EGFR Tyrosine kinase inhibitor (TKI) were enrolled in 4 study sites in Japan.|Eligible participants received gilteritinib in combination with erlotinib 150 mg. At least 3, and no more than 12, dose-limiting toxicity (DLT)-evaluable patients were to be enrolled in a given dose cohort. Dose escalation, cohort expansion or de-escalation decisions were to be guided by a modified toxicity probability interval design.
720999|NCT02495168||Participants (N=1714) were provided a generic placebo pressurized metered dose inhaler (pMDI) device for use during a 2-week Run-in Period for device training. Then, qualified participants (N=1147) were randomly assigned to treatment on a 4:4:1 ratio of generic budesonide/formoterol fumarate dihydrate, Symbicort, or Placebo, respectively.
721000|NCT02495038||
721001|NCT02495025||
721002|NCT02494817||
721003|NCT02494713||
721004|NCT02494596||Participants were grouped into three cohorts and received either 825 mg, 1000 mg or 1250 mg capecitabine to determine the maximum tolerated dose.
721005|NCT02494583|Participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who were programmed death-ligand 1 (PD-L1)-positive (Combined Positive Score [CPS]≥1) and human epidermal growth factor receptor 2 (HER2/neu)-negative were recruited to the study.|Of 1,787 screened, 763 were randomized 1:1:1 to the pembrolizumab monotherapy (pembro mono) arm, pembrolizumab plus standard of care (SOC) chemotherapy (pembro combo) arm, or placebo plus SOC chemotherapy (SOC) arm.
721006|NCT02494518||
721007|NCT02494440|"study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital from march 2015 to march 2016.
~Ninety pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria. They were counseled and after consenting were included into the study."|
721008|NCT02494401|Study recruitment occurred at two sites, The University of Michigan and the Medical University of South Carolina. Recruitment also took place utilizing social media, with the help of our patient partners and the Sclerderma Foundation and Scleroderma Research Foundation.|Participants completed baseline questionnaires. Participants were randomized to the intervention or control condition using a 1:1 ratio and computer-generated block randomization, and were stratified based on scores on the Patient Health Questionnaire-8 (<10, >10) in the baseline questionnaire.
721009|NCT02494336||
721010|NCT02494323|Recruitment occurred between 01May to 03Dec2015. Subjects were recruited through Bet-Loweinstein Head Trauma Rehabilitation Department and through Bioness Ltd Clinic Clinic.|
721011|NCT02494206||
721012|NCT02494180||
721013|NCT02494102||16 patients violated the study protocol and were excluded from the study. Exclusions included Day of Surgery refusal of study medication, surgical case cancellation, and surgeon refusal to participate.
721014|NCT02494076||
721015|NCT02493946|Subjects with moderate or severe glabellar lines were enrolled in 24 sites in France, Germany and the United Kingdom from 23 April 2015. The study was completed in December 2016.|605 subjects were screened. 192 were screened for the double blind (DB) period; 2 were screen failures and 190 were randomised to treatment or placebo. 413 additional subjects were screened for the open label (OL) period referred to as de novo subjects; 3 were screen failures and 410 received at least one treatment cycle.
721016|NCT02493868|Total of 719 participants were enrolled out of which 705 were included in the analysis. 14 participants were excluded due to premature closure of a site due to quality and data integrity issues.|Out of 705 participants, 437 (direct entry [DE] participants) entered in induction (IND) phase and 268 participants (150 transferred-entry [TE] participants from study ESKETINTRD3001 [NCT02417064] and 118 participants from study ESKETINTRD3002 [NCT02418585]) entered in this study in optimization (OP) phase.
721017|NCT02493855|This study was conducted at one clinic in France and one clinic in the United States. Participants were treatment-naïve adults with hepatitis C virus (HCV) genotype (GT)1a infection without cirrhosis.|Participants were randomized to Arms A or B in a 1:1 ratio first, and once those arms fully enrolled, Arm C was enrolled. Randomization to Arms A and B was stratified by site.
721018|NCT02493777|A total of 125 participants were enrolled in this study, of which 119 were randomized to double-blind, placebo-controlled treatment at 6 sites in the United States from 28 July, 2015 to 04 March, 2015.|The study consisted of a screening period of up-to 4-weeks, followed by a 6-week open-label HLD200 treatment-optimization period that was followed by a 1-week randomized (1:1), placebo-controlled, double-blind period.
721019|NCT02493764|Adult male and female participants requiring intravenous (IV) therapy for hospital-acquired bacterial pneumonia (HABP) or ventilator-assisted bacterial pneumonia (VABP) were recruited at 120 study centers in 28 countries.|
721020|NCT02493751||In this study, a lead-in period was conducted (only axitinib administered) in few participants prior to the administration of combination treatment (axitinib+avelumab) in treatment period. Data reported based on data cut off on primary completion date (03 April 2018).
721021|NCT02493712|Started recruitment on 2016/01/01 Completed recruitment on 2018/07/01|No patient was excluded before assignment to groups.
721352|NCT02462382|Potential subjects were asked to participate during their clinic visits.|
721353|NCT02462291||
721354|NCT02462148||
721355|NCT02462122||
721356|NCT02462083||
721357|NCT02462070||
721022|NCT02493621|Inclusion criteria included primary, elective THA with either lumbar epidural (n=547) or lumbar plexus peripheral nerve block (n=219) for postoperative analgesia. Exclusion criteria included THA revision, traumatic fractures, non-elective surgeries, and postoperative ICU admission. 342 epidural &107 lumbar plexus patients met inclusion criteria.|Subjects meeting inclusion criteria were assigned a chronological number based on the date of their operation (Epidural 1-342; Lumbar plexus 1-107) and then randomized using Microsoft Excel. Data were collected on the first 58 randomized subjects in each group; 58 epidural patients and 58 lumbar plexus patients.
721023|NCT02493608||4 were excluded from due to prior midline vertical skin incision.
721024|NCT02493517|Adult subjects with active acromegaly, defined as elevated Insulin-like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels, were recruited into 10 study sites in China.|170 subjects were screened and 128 eligible subjects were stratified according to surgical history (previous pituitary surgery or no previous pituitary surgery) and randomised in a 1:1 ratio to receive lanreotide Autogel or lanreotide prolonged release (PR). All randomised subjects were treated.
721025|NCT02493452||
721026|NCT02493361||
721027|NCT02493257||
721028|NCT02493127||
721029|NCT02493088|March 3 2015 to May 30 2015 Rochefort prison|Patient with a negative psychopathy score at PCL-R were excluded A patient was transfered before assignment
721030|NCT02493062|Recruitment period was June, 2013 through August, 2016. Patients were recruited for study during fetal surgery evaluation in the St. Louis Fetal Care Institute office. If patients were interested in participating in the study, the research nurse contacted the patient after delivery and set up an appointment at 6 months postpartum.|
721031|NCT02493036||
721032|NCT02492997|Enrollment was opened in March 2015. By time of study closure in October 106, only 44 of the planned 60 subjects had been enrolled to the study. As such, the trial was terminated due to slow enrollment.|Two subjects were reported to have been screen failed.
721033|NCT02492984||As there were 2 participants who rolled over from the surgical prophylaxis group to the on-demand group should be counted once in total column, the total number of baseline participants was 85.
721034|NCT02492958||
721035|NCT02492880||15 subjects were enrolled in the study. 1 subject was enrolled in error who did not meet all inclusion criteria and was withdrawn and 1 subject was lost to follow-up prior to completing the Programming Visit. Statistically relevant conclusions cannot be made from this small sample size.
721036|NCT02492841||
721037|NCT02492802||
721038|NCT02492763|This study was conducted at 84 clinical trial sites in Australia, Colombia, Guatemala, Israel, Spain, New Zealand, and in the United States. Five hundred participants were screened and 176 randomized.|
721039|NCT02492750||
721040|NCT02492451||
721041|NCT02492295|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
721042|NCT02492165|Study participants were enrolled from 27 June 2015 to 24 August 2015 at 1 clinic center in Vietnam.|A total of 250 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
721043|NCT02492100||
721044|NCT02491944|First subject enrolled: 10 July 2015; Last subject last visit: 26 August 2015. This study was conducted in a single study centre in the UK.|27 subjects were enrolled (signed informed consent). Subjects were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 17 subjects were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 10 subjects received treatment.
721045|NCT02491892||
721046|NCT02491788||
721047|NCT02491684|First patient enrolled: 21 July 2015; Last Patient Last Visit: 24 November 2016. The study was performed at 39 sites in 7 countries including Argentina, Australia, Colombia, France, South Korea, Spain and the United Kingdom.|349 patients enrolled (signed informed consent) and 228 were not randomised. 121 patients met randomisation criteria and entered the pre-treatment phase. Patients were treated after developing symptoms of an upper respiratory tract infection (URTI) if they met all the inclusion criteria and none of the exclusion criteria for the treatment phase.
721048|NCT02491463||Out of 73 subjects originally enrolled in this study, only 72 subjects received the study vaccination and were hence included in the Total Vaccinated Cohort.
721049|NCT02491437||
721050|NCT02491411||One of the five patients enrolled, failed screen due to declining Eastern Cooperative Oncology Group (ECOG) Score of 3, and therefore could not start study.
721051|NCT02491359||
721052|NCT02491073||
721053|NCT02490670||
721054|NCT02490631||
721055|NCT02490475||
721056|NCT02490371|A convenient sampling method was adopted. Patients who were diagnosed with their first-ever stroke and referred to the Physiotherapy Department at Queen Elizabeth Hospital for post-stroke rehabilitation between November 2015 to December 2016 were screened for eligibility by an independent physiotherapist using inclusion criterias.|"Exclusion criteria:
~Mini Mental State Test score ≤ 24;
~Mental illness;
~Contra-indications to rTMS according to guidelines formulated by Wassermann (e.g., intracranial implants, epilepsy, cardiac pacemaker, implanted medication pumps); 4 Unstable cardio-pulmonary condition."
721057|NCT02490293||
721058|NCT02489981|The objective of this Post Marketing Surveillance (PMS) was to investigate the safety and effectiveness of Spiriva Respimat in patients with severe persistent asthma under real-world use. This is a regulatory required PMS to investigate the safety and effectiveness of Spiriva® 2.5 μg Respimat® 60 puffs in patients.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
721059|NCT02489968||880 subjects started the open label period
721060|NCT02489799||
721061|NCT02489773|This was a prospective, multicenter, comparative, pivotal study of assay performance in the clinical setting. The target population for this study included up to 150 patients placed into 2 groups, each containing approximately equal numbers of patients with Type 1 or Type 2 diabetes.|A total of 165 patients were screened for the study, 150 patients were enrolled.
721064|NCT02489344|Participants who successfully completed 26 weeks of treatment in prior ACT13739 study (NCT02228460) were eligible to continue their treatment for up to 30 additional months in this extension study LTS14116. Eleven participants had enrolled and were treated in ACT13739 study, and 9 completed study. Of these 9 participants, 8 entered extension study.|In extension study, participants continued on same dose regimen they had received in initial study. Two participants in LTS14116 completed treatment and did not discontinue early, but are counted as not completed study due to no record of completion.
721065|NCT02489279|Participants were recruited from university clinics, local clinics, private practice clinicians and Attention-Deficit Hyperactivity Disorder (ADHD) groups.|107 participants were screened and diagnosed and met eligibility criteria to be assigned to treatment. Of these, 22 declined to participate in the treatment stating that they changed their minds and that the treatment and follow-up testing would take too much time, leaving 85 randomized and assigned to treatment.
721066|NCT02489227||
721067|NCT02489110||
721068|NCT02488980|"This study was conducted at Kombewa Clinic, Kenya. 517 subjects were screened for entry in to the study. 211 of those subjects were not randomized to treatment due either to abnormal lab results, G6PD deficiency, extended QTc interval, failure to clear parasitaemia or other reason."|
721069|NCT02488915||
721070|NCT02488824||
721071|NCT02488681|A total of 285 subjects were consented at 31 research centers in the United States from June 2015 to April 2016 when FDA approval was obtained.|Of the 285 patients that were consented to participate in the study, 276 patients underwent a Micra implant attempt. Nine patients who were consented into the study did not ultimately have a Micra implant attempt prior to study closure.
721072|NCT02488330|Participants with solid tumors previously enrolled in an F. Hoffmann-La Roche and/or Genentech parent trial (P-trial) who received either the control treatment or onartuzumab-based study treatment, had not met the treatment discontinuation criteria for their P-trial, and were able to start treatment within 42 days of the last day of their P-trial.|
721073|NCT02488317||
721074|NCT02488239|The first subject was enrolled on 11 May 2015 and the study was completed on 22 March 2017, which corresponds to the last visit of the last subject. A total of 64 subjects across 8 centers were enrolled in Finland and Germany.|
721075|NCT02488070||
721076|NCT02488018|After a through orientation on research objectives to 3rd year Food Science & Technology students, 14 volunteer free of: overweight, dieting, smoking, family history of diabetes, pregnant, metabolic disorders, and suffering from food allergy were selected. Out of 14 eligible students, 5female and 5male students were selected using lottery sampling.|The Addis Ababa University, College of Natural Sciences, Research Institutional Review Board (IRB) approved this study. Written consent forms were obtained from all 14 volunteers (7 females and 7 males).
721077|NCT02488005||
721078|NCT02487979||
721079|NCT02487810||
721080|NCT02487771|Participants were recruited from 7/17/2008 to 4/24/2012.|Participants were required to have been enrolled in the parent trial.
721081|NCT02487563|Two participants from different institutions submitted the applications at the same time when there was only one quota left. Both of them met the inclusion criteria and were enrolled.|
721082|NCT02487498||Participants were randomized to 1 of 2 sequences in a 1:1 ratio.
721083|NCT02487485||
721084|NCT02487472|Inclusion timeframe for the study was initially planned for 6 months. Due to the low rate of inclusion, this timeframe was extended from 6 to 13.5 months. A total of 106 subjects from the Herpes Zoster (HZ) cohort were included in this study.|Out of 106 subjects included,5 subjects were excluded due to the following reasons:<50 years,previous history of HZ ,not the first visit,consulted physician more than 2 weeks after start of HZ symptoms. A total of 101 subjects were included for analysis.Out of the 101 subjects,90 subjects completed the study.
721085|NCT02487446||Participants were randomized to 1 of 2 sequences in a 1:1 ratio.
721086|NCT02487303||
721087|NCT02487277||"Study was terminated earlier than expected due to low accrual so no participants were enrolled in the Combination therapy alone treatment arm."
721088|NCT02487225|Subjects were recruited at Mayo Clinic in Rochester, Minnesota.|
721089|NCT02487199||This study included a 42-day screening period.
721090|NCT02487056||
721091|NCT02487030|Participants were enrolled in 4 sites in Egypt. The first participant was screened on 07 September 2015 and the last study visit was on 04 February 2017.|289 participants were screened.
721092|NCT02486952||
721093|NCT02486939||
721094|NCT02486796||
721095|NCT02486757||
721096|NCT02486692||
721097|NCT02486653|Recruitment began in August 2015 and continued until Feb 2018. Subjects were recruited from surgery clinics at a single university hospital.|Subjects were randomized within 1 month of their surgery date but >7 days prior to surgery. 7 participants were not randomized for the following reasons: 4 subjects self-withdraw prior to randomization; 3 subjects had surgery date moved up to within the 7-day window before surgery
721098|NCT02486627||
721099|NCT02486588||
721100|NCT02486328||
721101|NCT02486302||
721102|NCT02486263||
721103|NCT02486211||
721104|NCT02486016||
721105|NCT02485925|A total of 201 patients from 12 sites in China were screened and 200 patients were enrolled into the study.|This was a prospective, multicenter, non-randomized clinical study. Patients were enrolled to receive THERMOCOOL® SMARTTOUCHTM catheter if signed informed consent forms and satisfied the study inclusion and exclusion criteria.
721106|NCT02485912||
721107|NCT02485834||Pre-randomization events included: 1) Baseline FDG-PET scan 2) Pre-registration 3) Second FDG-PET scan. Screen failures excluded from the study before randomization consisted of ineligible patients (n = 13), investigator decision (n = 1), and other screen failure reason (n=1).
721108|NCT02485717||"Exclusion Criteria #2 - Has a household member(s) who is not willing or not eligible to enroll.
~Exclusion Criteria #12 - Administration of systemic therapy for infectious disease within the prior 2 weeks."
721579|NCT02443337||Participants completed the study if they had objective progressive disease (PD), stable disease (SD), complete response (CR) or partial response (PR).
721109|NCT02485704|18 subjects were excluded from the ITT (intent-to-treat), I-ITT (index intent-to-treat), and I-PP (index per protocol) populations due to noncompliance with the randomization procedures. As such, only 262 subjects (145 in the Natroba group and 117 in the placebo group) were included in the ITT population.|Inclusion Criteria #2 - At least one household member must have active scabies infestation confirmed.
721110|NCT02485561|We sent electronic invitations to prospective participants from two opt-in registries: 1) Washington University's Volunteer for Health Research Participant Registry and 2) ResearchMatch.org hosted by Vanderbilt University.|Nearly all participants completed all study components online. They provided informed consent and proceeded to the baseline survey (n=486). Only those that completed the baseline survey were randomized (n=477) to one of three intervention conditions, so that number is smaller than the total who started the study.
721111|NCT02485483||
721112|NCT02485353|This protocol was based on enrolling 20 patients. Due to the death of 2 patients which raised safety concerns, the study was closed with 2 patients enrolled.|
721113|NCT02485301||During the screening period the following steps took place: signing of informed consent, checking of inclusion/exclusion criteria, demographic data collection, medical history collection, physical examination, pregnancy testing.
721114|NCT02485158|Healthy social drinkers were recruited from the Chicago area through flyers and online advertisements, from June 2013 through February 2014.|
721115|NCT02484911||
721116|NCT02484898||
721117|NCT02484859|Recruitment period started at 27.06.2015. Recruitment was performed by an anaesthesiologist at the outpatient polyclinic for anaesthesiology.|A total of 105 patients were evaluated. Three patients declined to participate in the study. Eleven patients did not meet inclusion criteria. On 29 December 2015, we reached the target number of patients (88). Since patients were matched for severity of sinonasal disease, we evaluated three more patients anticipating possible dropouts.
721118|NCT02484807|March 2015 - September 2015|
721119|NCT02484729|This study was conducted at PAREXEL International, Early Phase Clinical Unit London, United Kingdom.|In this study, 196 subjects were screened out of which 70 subjects were randomized. The study was conducted in two parts (Parts A and B). Part A-eight cohorts of 8 subjects, randomized in 6:2 (AZD9977: placebo) and Part B -1 cohort of 8 subjects who received a single dose of AZD9977, on 2 occasions separated by washout period of 7 days.
721120|NCT02484690||A total of 273 patients were randomized, but 10 participants in total were excluded from the analysis populations, 1, 3, 1, and 5 from Arms B, C, D, and E, respectively, because of Good Clinical Practice (GCP) violations at a single site.
721121|NCT02484651|Recruitment started on the 2016/9/19 and finished on 2017/6/28 at Centro Hospitalar do Porto, Portugal.|"3 patients were excluded from the study after screening (signing the informed consent) but before randomization and assignment to the groups, due to:
~2 patients had their surgery postponed less than 2 hours before the schedule time
~the scheduled surgical position of 1 patient was altered by the surgeon just before the start of the procedure."
721122|NCT02484222||Children at age of 3 - 7 years with OSAS,The exclusion criteria were craniofacial deformities, mental retardation, BMI > 22 kg/m², a history of bronchial asthma, and a recent history of opioid use.
721123|NCT02484092|A total of 22 participants were screened, 15 participants were assigned to treatment and completed study. All 15 participants received the lowest dose in the study (5 x 10^11 vg/kg). No participants were assigned to the 2 higher dose arms. Results presented here are from the lowest dose level.|
721124|NCT02483975|Eligible participants (par.) aged between 5 to 11 years with asthma were enrolled to either receive fluticasone furoate (FF) or placebo by inhalation through ELLIPTA for 6 weeks (wks) (42 days (D)). A total of 156 par. were screened, of which 111 par. were randomized in the study.|Par. receiving non-corticosteroid controller and/or short-acting beta 2-agonist (SABA) therapy were screened for the study. Par. went through a Run-in Period of 7 to 14 D before the 6 Wk Treatment Period.
721125|NCT02483676||
721126|NCT02483611|After approval by the Research Ethics Committee, 48 patients were selected for the study. Patients were invited to participate in the study during the pre-anesthetic evaluation, at which were told about the objectives, benefits and risks of research and those who agreed to participate signed the free consent form.|
721127|NCT02483585|This study was conducted at 69 centers in Denmark, France, Greece, Portugal, Russia, Spain, Switzerland, and the USA. Participants were enrolled from 20 July 2015 to 19 April 2016.|Participants were randomized 1:1 to placebo or erenumab 70 mg once a month (QM). Randomization was stratified by region (North America vs Other) and treatment status with migraine prophylactic medication (current, prior, or no prior or current migraine prophylactic medication treatment).
721128|NCT02483572||
721129|NCT02483533||
721130|NCT02483520|Site A participants were recruited by advertisements in local media, university email, and regional conferences for caregivers. Site B participants were primarily recruited through an Alzheimer Disease center, a memory care clinic, and community outreach activities.|Caregiver-Person with Dementia (PWD) dyads were randomly assigned to the intervention (FamTechCare) group or the attention control group using a quarter-based blocking strategy with 1:1 allocation developed by the study statistician. Caregivers in multiple dyad homes were cluster randomized to the same group.
721131|NCT02483416|The study was conducted in 14 French active centres and lasted 14 months. The recruitment phase was stopped after 10.7 months. Each patient participated for approximately 3 months. Actual subjects enrolled were 30 but two subjects are not included because of incomplete case record form (CRF)|Patients for whom a decision of treatment with afatinib monotherapy has been taken in the frame of its marketing authorization were included in this trial.
721132|NCT02483000||
721133|NCT02482935||In this two-period crossover study, abemaciclib was administered once (fasting or fed) in each period. There were at least 16 days between doses and follow-up was completed 15 to 18 days after the last dose in Period 2.
721134|NCT02482870|This study enrolled adult patients scheduled for general anesthesia with intubation in Recep Tayyip Erdogan University Education and Research Hospital. The last patient completed in July 2014.|None of the 388 patients enrolled between January 2014 and July 2014 were excluded from the trial.
721135|NCT02482805||
721136|NCT02482675||
721137|NCT02482610||
721138|NCT02482571||
721139|NCT02482428|A total of 88 patients were randomized and treated in the study|
721140|NCT02482298|This study was conducted at 26 centers in 8 countries between 09 July 2015 and 16 November 2016.|The study duration was approximately 18 weeks, consisting of a screening period including a 4-week single-blind placebo treatment for baseline assessments, a 12-week double-blind randomised treatment period, and a 2-week follow-up period. A total of 87 patients were randomized
721141|NCT02482233||
721142|NCT02482129|Subjects were recruited from 10 study centers located in the United States.|Of the 45 enrolled, 2 subjects were exited as screen failures prior to randomization and 4 subjects were randomized, but not treated. This reporting group includes all randomized subjects, as treated. Note: One subject randomized to LME636 was treated with dexamethasone instead.
721143|NCT02482025||
721144|NCT02481947||
721145|NCT02481934|Recruitment was performed between march 2013 and october 2014 at Hospital 12 de Octubre in Madrid.|
721146|NCT02481830||803 Participants were enrolled into the study,569 Randomized ,212 not randomized, reasons not randomized:2 adverse events(AEs),20 consent withdraw, 12 death, 2 loss of follow up,176 not meet study criteria.
721147|NCT02481596||5 subjects were never reached for a required conversation prior to starting the text messaging program--they were withdrawn by the PI. 1 subject was withdrawn by the PI due to problematic behavior during enrollment.
721148|NCT02481557||
721149|NCT02481440||
721150|NCT02481375||
721151|NCT02481297|Recruitment Period: September 2015 to April 2016|
721152|NCT02481258||Patients were required to complete initial testing for valve calcium and function (in addition to other tests/screening characteristics) prior to enrollment.
721153|NCT02481219||
721154|NCT02481141||
721155|NCT02481050|Participants took part in the study at 12 investigative sites in the United States from 16 June 2015 to 05 September 2017.|A total of 74 participants were screened, of which 16 were screen failures and 58 were randomized to receive study treatment.
721156|NCT02480998||
721157|NCT02480920||
721158|NCT02480764|Participants took part in the study at 30 investigative sites in China from 27 August 2015 to 13 October 2017.|Participants with a diagnosis of hypertension were randomized at a ratio of 1:1:1 into 1 of 3 treatment groups, once a day azilsartan medoxomil 40 mg, azilsartan medoxomil 80 mg or valsartan 160 mg.
721159|NCT02480712|Participants were enrolled at 17 study sites in the United States. The first participant was screened on 01 July 2015. The last study visit occurred on 22 June 2016.|149 participants were screened.
721160|NCT02480621||
721161|NCT02480582|"Recruitment Start Date: June 2015
~Recruitment End Date: October 2015
~Responses to Study Advertisement: 303
~Number of Participants Invited to Screening Session: 85
~Number of Participants Screened: 49
~Number of Participants Recruited: 42
~Number of Participants Completed: 42"|
721162|NCT02480439|Participants took part in the study at 1 investigative site in the United States from 23 June 2015 to 02 September 2015.|Healthy participants were enrolled equally in 1 of 3 treatment sequences that determined the order of the three treatments received: TAK-648 0.3 mg tablet (fed), 0.3 mg tablet (fasted) and 0.3 mg solution (fasted).
721163|NCT02480166||
721164|NCT02480153||A total of 1231 potential participants were screened after signing an informed consent form, of whom 597 participants were randomized to receive study treatment.
721165|NCT02480114|Participants were enrolled at Vanderbilt Medical Center in Nashville, TN from July 2015 to May 2019. 79 participants were recruited and 8 of those withdrew.|
721166|NCT02480010||
721167|NCT02479880|Participants were enrolled at study sites in Europe. The first participant was screened on 03 July 2015. The last study visit occurred on 11 April 2018. The study did not achieve targeted enrollment as it was prematurely terminated by the Pharmacovigilance Risk Assessment Committee (PRAC).|35 participants were screened.
721168|NCT02479802||
721169|NCT02479763||
721170|NCT02479412|The study was conducted in Germany (9 centers) and Bulgaria (1 center). A total of 54 participants with mild to moderate asthma were randomized after screening, and received study treatment (AZD7594 or placebo) given over 3 Treatment Periods in an incomplete block crossover design.|The study consisted of a 2-part run-in period, 3 treatment periods separated by intervening wash-out periods, and a final period of safety follow-up .
721171|NCT02479139||
721172|NCT02478671||
721173|NCT02478632|Participants from early switch dolutegravir (DTG) plus rilpivirine (RPV) treatment groups and from late switch group who continue their current antiretroviral regimen (CAR) through Week 52 across both NCT02429791 and NCT02422797 were included in this sub-study 202094.|Total 146 participants were screened, of which, 44 were screen failures and 102 were registered to study 202094. The study included an early switch phase and a late switch phase.
721174|NCT02478580||
721175|NCT02478463|This was a Phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir (CAB) long-acting (LA) in the blood plasma and anatomical tissues and secretions associated with sexual human immunodeficiency virus (HIV)-1 transmission. The study was conducted across two centers in the United States.|A total of 29 participants were screened, of which 10 failed screening. A total of 19 participants were enrolled in the study and received study treatment.
721176|NCT02478398||
721177|NCT02478372||
721178|NCT02478359|Eligible patients were randomly assigned 1:1 to Walk On! or Standard Care arm at the point of identification of eligibility based on EMR data.|"Patients assigned to the Walk On! arm were all approached to participate in and consent to the intervention activities.
~Only a randomly selected subgroup within Standard Care (n=537) were approached to complete surveys for comparison with the Walk On! group."
721179|NCT02478164|Study began enrolling on 7/13/2015 and enrolled the last participant on 6/13/2017. Enrollment was stopped during a planned interim analysis due to futility. 17 participants were enrolled, but only 15 went on to receive ponatinib study treatment, as 2 participants withdrew after enrolling and before beginning ponatinib.|
721180|NCT02477709||
721358|NCT02462057||5467 individuals were eligible in 1/2015. This sample was identified months before randomization to allow individuals time to learn about HF from other sources and enrol if interested. Prior to randomization, we excluded participants who joined HF of left Vitality since identification. This is why the initial and randomized samples are unequal.
721181|NCT02477670|Of the 145 participants randomized at the beginning of the study, 127 patients met the criteria for the Modified Intent-to-Treat (mITT) Population and were included in the Stage 1 mITT Population. A total of 108 participants were included in the Stage 2 mITT Population.|Participant Flow data are reported for members of the mITT Population. Stage 1: participants randomized in Stage 1 who had at least 1 post-baseline NSA-16 total score assessment in Stage 1. Stage 2: participants who were re-randomized into Stage 2 and had at least 1 NSA-16 total score assessment in Stage 2 (after Week 6).
721182|NCT02477618|Participants took part in the study at 122 investigative sites in Canada, United States, Austria, Denmark, Estonia, Finland, France, Germany, Israel, Italy, Serbia, Spain and United Kingdom from 31 July 2015 to 11 August 2017.|Participants 2 years of age and older with Super-Refractory Status Epilepticus were eligible. One participant in the placebo group was erroneously given SAGE-547 and was, therefore, included in the SAGE- 547 group.
721183|NCT02477605|Subjects were recruited from 6 study centers located in the US.|Of the 137 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (136).
721184|NCT02477553|Participants were recruited from primary care practices between June 2015 and December 2016.|
721185|NCT02477527|Recruited from private office practice.|Participants had to be stable on Atripla for at least 6 months with undetectable viral load.
721186|NCT02477423|Patients in the study were enrolled from The University of Chicago Comer Children's Hospital, a level IV NICU in Chicago, Illinois, as well as Northshore University HealthSystem Evanston Hospital, a level III NICU in Evanston, Illinois from 2015-2018.|
721187|NCT02477332|574 subjects screened; 382 subjects randomized; 338 (88.5%) subjects completed treatment epoch; 349 (91.4%) subjects entered follow-up phase and 320 (83.8%) completed the follow-up epoch|
721188|NCT02477319|Enrollment Period: March 2015 - June 2017 (revised)|
721189|NCT02477215||
721190|NCT02477020|Participants took part in the study at 13 investigative sites in United States from 01 July 2015 to 27 July 2016.|Participants with a diagnosis of acute exacerbation of schizophrenia were enrolled in two treatment groups TAK-063 or placebo.
721191|NCT02476994||
721192|NCT02476916|Participants were recruited in the core period of the study at 14 investigative sites in the 6 countries from 13 July 2015 to 14 July 2017 (data cut-off date). The core period is completed, and results of this period are reported. The extension period is ongoing.|A total of 52 participants were enrolled in the Core Period of the study. Out of 52 participants, 9 discontinued during the core period, and 43 completed the core period. Out of these 43, 36 entered the extension period, and 7 did not enter the extension period and were followed up to 4 weeks after their last dose of AG-348 in the core study.
721193|NCT02476890||A 6-day Screening period (Day -6 to Day -1) ensured that each participant met all the specified eligibility criteria. In addition, cough reflex sensitivity was measured at Screening by standard clinical methodology using cough challenge in response to four agents (capsaicin, citric acid, adenosine triphosphate (ATP), and distilled water).
721194|NCT02476617||The intent-to-treat (ITT) population consisted of all enrolled participants who received at least one dose of study drug.
721195|NCT02476578||"Some of the participants may fit more than one criterion, as explained in the Eligibility section. Hence 7 subgroups are created:
~A) Fit only alert 1. B) Fit only alert 2. C) Fit only alert 3. D) Fit both alert 1. and alert 2. E) Fit both alert 1. and alert 3. F) Fit both alert 2. and alert 3. G) Fit all alerts: 1. , 2. and 3."
721196|NCT02476565||
721197|NCT02476448||
721198|NCT02476422||
721199|NCT02476357||
721200|NCT02476201|Subject enrollment began on 11-Feb-2016 and the last enrollment occurred on 13-Aug-2018.|
721201|NCT02476175||
721202|NCT02476032||
721203|NCT02476006|The study was conducted at 156 sites in 17 countries. A total of 1305 participants were screened between 23-June-2015 to 27-December 2016, of whom 307 were screen failures. Screen failures were mainly due to exclusion criteria met.|A total of 998 participants were enrolled in the study.
721204|NCT02475980||
721205|NCT02475837||17 participants were enrolled, 13 were randomized.
721206|NCT02475733||
721207|NCT02475655|Enrollment began in 05/2016 and completed in 01/2018. Of N=119 screened subjects, N=60 were enrolled from fourteen clinical research sites in the United States.|Enrollment was stratified based on whether a participant was on an EFV-containing regimen.
721208|NCT02475629||
721209|NCT02475564|Between June 18th and November 6th, 2015, 234 women with diagnosis of endometriosis were screened for the study at outpatient clinic of Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil|
721210|NCT02475395|Men were recruited at three medical clinic sites from 2 September 2015 to 4 December 2015.|
721211|NCT02475278|Participants took part in the study at 1 investigative site in the United States from 26 February 2015 to 9 September 2015.|Healthy volunteers were enrolled in 1 treatment group and received a single dose of NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide).
721212|NCT02475265||
721213|NCT02475070||
721214|NCT02475031||
721215|NCT02474901||
721216|NCT02474589||
721217|NCT02474498||
721218|NCT02474407|This is a randomized crossover study with 78 subjects total.|
721219|NCT02474082||A total of 202 (secukinumab: 105 and fumaric acid derivatives: 97) participants were randomized in the study out of which 200 (secukinumab: 105 and fumaric acid derivatives: 95) received treatment. 2 participants were discontinued from the study due to non-compliance with study treatment (1) and withdrawal of informed consent (1).
721220|NCT02474069|860 screened (not shown here). In selection phase (SP), 772 received 300 mg s.c. open-label secukinumab at baseline to wk 12. Those who did not achieve ≥Psoriasis Area and Severity Index (PASI) 75 at wk 16 discontinued. Those who had ≤ clear or almost clear skin (≥PASI75 but not PASI90) rolled over into double blind comparative dosing phase (CDP).|and randomized 1:1 to: a.standard treatment: 300 mg s.c. secukinumab treatment every 4 weeks (weeks 16, 20, 24, & 28) and, to maintain the blind, placebo every 4 weeks b. OR dosage interval shortening: 300 mg s.c. secukinumab treatment every 2 weeks Those who achieved at least clear or almost clear skin (≥ PASI 90) at week 16 discontinued study
721221|NCT02473991||
721222|NCT02473965|Sixty subjects with a confirmed diagnosis of generalized myasthenia gravis (MG) historically meeting the clinical criteria for MG diagnosis Class II, III, IV or V of the Myasthenia Gravis Foundation of America were randomized. The study was conducted in 8 countries from November 2015 to February 2019.|Subjects had symptoms at screening controlled by corticosteroids (CS), had been dependent on systemic CS for at least the preceding 3 months and had received a stable dose of CS for at least 1 month immediately prior to the screening visit.
721223|NCT02473952||
721224|NCT02473913||This is a crossover study. Therefore, only 22 participants were technically enrolled, but they each were supposed to complete both the placebo and the Milk Thistle Arm.
721225|NCT02473783|The recruitment period was from Oct-07-2011 to Nov-28-2012. The recruitment site was a psychiatric outpatient in a medical center.|"The treatment group:
~No significant events in the study that occur after participant enrollment.
~The healthy control group:
~No significant events in the study that occur after participant enrollment."
721226|NCT02473718||
721227|NCT02473640||
721228|NCT02473523|Two participants were enrolled between February and April 2016.|
721229|NCT02473510||A total of 300 participants were randomized and participated in the study from 15-Jun-2015 through 15-Jan-2016 at 3 sites in the United States of America (USA).
721230|NCT02473471|Participants recruited from a postgraduate clinic at Jordanian University of Science and Technology, in Irbid city, Jordan between Aug 2015 and Jan 2016.|
721231|NCT02473445|Participants who completed study RP103-MITO-001 (NCT02023866) study were eligible for enrollment into this extension study. The study was conducted at 5 sites in the United States.|
721232|NCT02473367|Males or females, at least 18 years of age, with HIV infection were enrolled in this trial.|Starting five days prior to Period 1 participants were treated with 1200 mg raltegravir (MK-0518), once daily for five days.
721233|NCT02473289||
721234|NCT02472977||61 participants were enrolled; 41 participants entered the treatment period.
721235|NCT02472964|500 subjects enrolled at 95 sites across Eastern Europe, Russia, Asia Pacific, Africa and South America. The intent to treat1(ITT1) population of 458 was used to determine Primary Outcome of Overall Response Rate.|The primary efficacy analysis was derived fromITT1 population 230 (MYL-1401O) + 228 (Herceptin)= 458. Safety analysis was derived from the Safety Population 247(MYL-1401O)+246(Herceptin)= 493. Total Randomized population 249(MYL-1401O) +251(Herceptin)= 500.
721236|NCT02472886|Participants were enrolled at study sites in Russia and Estonia. The first participant was screened on 17 June 2015. The last study visit occurred on 30 June 2016.|169 participants were screened.
721237|NCT02472847||Participants completed initial screening visit, signed consent, if eligible scheduled for 4 fMRI scans. Participants were randomized immediately before the 2nd fMRI scan. Reasons for exclusion prior to randomization: 6 excluded during initial screening, 13 lost to follow up, 5 did not want to take study drug, 11 had scheduling conflicts.
721238|NCT02472795|This study was conducted at 18 sites in 6 countries between 1 June 2015 and 28 February 2017, 105 patients signed consent and 67 were randomized to a study treatment: 49 in part A (randomized 1:1:1:1 to receive cenerimod 0.5, 1, 2 mg or placebo) and 18 in part B (randomized 3:1 to receive cenerimod 4 mg or placebo).|The screening period started when the informed consent was signed (up to 30 days before randomization), and ended with randomization. The period included Visit 1 (screening) and the pre-randomization (pre-dose) assessments at Visit 2 (Day 1). Thirty-two patients did not meet the inclusion/exclusion criteria and 6 patients withdrew from the study.
721239|NCT02472756||All treatments prescribed during the observation period were at the treating physician's discretion and should have been prescribed according to package labeling, within approved indication and local approval status of respective drugs.
721240|NCT02472730||
721241|NCT02472652||
721242|NCT02472639||
721243|NCT02472522|The study was conducted between May 2015 to November 2015 in the Obstetrics and Gynaecology Operation Theater and Post-operative ward of the Tata Main Hospital, Jamshedpur, India.|
721244|NCT02472457||
721245|NCT02472405||
721246|NCT02472366||
721247|NCT02472353|Referrals and investigator's own patients|
721248|NCT02472314|This prospective, randomized, controlled study included 70 consecutive shoulder arthroplasty patients from August 2015 through June 2016 during the period of 1 year at one location.|
721249|NCT02472262||
721250|NCT02472145||
721251|NCT02471755|This prospective RCT was conducted at Guang'anmen Hospital, China Academy of Chinese Medical Sciences (Beijing, China), from April 2013 to December 2014. Participants with MT were recruited via hospital posters.|A total of 192 participants were assessed for eligibility; 102 participants were excluded from the trial(53 didn't meet inclusion criteria, 26 declined to participate the trial, 23 for other reasons). 90 participants were randomly allocated to the EA group or the sham EA group.
721252|NCT02471651||
721253|NCT02471612|All who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, India who met the inclusion criteria were included in the study|
721254|NCT02471521|This single-center study was performed in a tertiary children's hospital in Republic of Korea.|
721255|NCT02471404||
721256|NCT02471326||
721257|NCT02471313||
721258|NCT02471183|Thirty-seven patients were screened. Among them, thirty-four patients with pulmonary arterial hypertension (PAH) and treated with inhaled treprostinil for at least 90 days were enrolled at 12 sites in the USA.|
721259|NCT02471014||56 consented. 6 participants failed secondary screening during the first visit.
721260|NCT02470949|Participants were recruited in the greater Denver, Colorado area in 2015 via flyers, online ads, television, and participant referrals.|
721261|NCT02470910||
721262|NCT02470806||
721263|NCT02470754||
721264|NCT02470741||
721359|NCT02461992|This study recruited Chinese male participants that were age 6 years or older with severe hemophilia A (factor VIII [FVIII] activity <1%) previously treated with >150 exposure days to any FVIII-containing product.|
721360|NCT02461966||
730044|NCT01790659|Subjects were recruited from three regions in Panama. Subjects were screened over a 28 day period.|
721265|NCT02470585|This trial was conducted at 188 sites in 10 countries (Australia, Brazil, Denmark, Israel, Japan, Poland, Republic of Korea, Spain, United Kingdom, and United States). The study is currently ongoing; the data-cutoff date for the primary analysis results reported below was May 3, 2019.|Participants were randomized in a 1:1:1 ratio to one of three treatment groups. Randomization was stratified according to the timing of surgery and residual disease after primary surgery, the paclitaxel schedule, stage of disease, geographic region, and germline breast cancer susceptibility gene (BRCA) status.
721266|NCT02470494||
721267|NCT02470429|Subjects were recruited from 3 study centers located in Germany, 3 study centers located in France, 2 study centers located in the UK, and 2 study centers located in Spain.|Of the 114 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (99).
721268|NCT02470403||Subjects were stratified by their glycemic status (dysglycemic or normoglycemic) and randomized to LIK066 or placebo within each stratum in each part of the study.
721269|NCT02470390||"A total of 13 healthy subjects were randomly assigned to treatment in this crossover study: 6 in the Nasal Fentanyl First, then Sublingual Fentanyl and IV Fentanyl arm and 7 in the Sublingual Fentanyl First, then Nasal Fentanyl and IV Fentanyl arm."
721270|NCT02470312||
721271|NCT02469961||
721272|NCT02469896||
721273|NCT02469870||
721274|NCT02469714|Recruitment began 8/24/2015 to 11/20/2015. Locations for recruitment included: Trilogy, National Alliance on Mental Illness Chicago, social service providers, community coalitions, religious organizations, health fairs, and health centers that provided free or sliding scale access to care.|No enrolled participants (from Baseline) were excluded from the study before or after assignment to groups
721275|NCT02469701||
721276|NCT02469623||
721277|NCT02469610||
721278|NCT02469597|Patients were enrolled at a tertiary care, academic children's hospital in the Pediatric Emergency Department from February 2013 to March 2016.|
721279|NCT02469415|Recruitment Period: October 2015 through February 2016. This study was closed by the FDA due to the Pacritinib hold. The study was closed to new patients February 10, 2016. All active patients were required to come off treatment at that time.|Three participants were registered on this study. One participant withdrew consent before receiving the study medication. Two participants were taken off study when the investigational agent was placed on full clinical hold by the Food and Drug Administration (FDA).
721280|NCT02469298|A total of 45 healthy adult participants with acute, uncomplicated influenza were enrolled. The study was conducted from 01-June 2015 to 25-April-2016 at 17 centres in 3 countries.|A total of 288 participants were screened for this study. Of these, 243 participants were screen failures and 45 were randomized. The reasons for screen failure included: not meeting inclusion/exclusion criteria (238 participants), lost to follow up (1 participant), investigator discretion (1 participant) and withdrew consent (43 participants).
721281|NCT02469246|Participants were enrolled at study sites in North America and Europe. The first participant was screened on 29 June 2015. The last study visit occurred on 13 March 2019.|626 participants were screened.
721282|NCT02469168||
721283|NCT02469116|The study opened to participant enrollment on 01/12/2006 and closed to participant enrollment on 12/01/2009.|
721284|NCT02469090|Patients with Levodopa (L-dopa) responsive idiopathic Parkinson's Disease (PD) complicated by motor fluctuations ('OFF' episodes) were recruited in 33 study sites in the United States and Canada starting June 2015. Study completed in December 2017. Approval was obtained from the Enrollment Adjudication Committee prior to enrollment of each patient.|The study included a Dose Titration Phase in which individual responses to single doses of APL-130277 (10 - 35 milligram [mg]) were evaluated at 5 mg dose increments to determine the starting dose that achieved a full 'ON' within 45 minutes. Patients were randomized at this dose to APL-130277 or placebo in the 12-week Maintenance Treatment Phase.
721285|NCT02469077||117 subjects consented and participated in Visit 1 to evaluate the nature of chronic back pain and confirm eligibility to engage in exercise manipulation. 15 subjects were discontinued from participation following this assessment. 9 additional subjects discontinued during preintervention lab session period.
721286|NCT02469064|The recruitment period lasted seven months. The collection was performed in an Intensive Care Unit of a IV level clinic in the city of Cali|"126 patients were randomized, 3 of them did not comply with the protocol, being assigned to the experimental treatment and receiving conventional treatment.
~No patient requested to be withdrawn from the study, and no patient had any adverse effects"
721287|NCT02469038||
721288|NCT02468934|Recruitment began September 2015 (with first subject enrollment in October 2015) and was concluded in February 2017. Subjects were screened for the study from a pool of candidates scheduled to undergo a primary unilateral total knee replacement procedure.|After obtaining informed consent, subjects were evaluated for eligibility.
721289|NCT02468830||
721290|NCT02468700||
721291|NCT02468674|This study was conducted in 30 centers in 12 countries: Australia (1), Belgium (1), Czech Republic (1), Denmark (1), France (2), Japan (10), Russia (4), South Korea (1), Spain (2), Switzerland (1), Taiwan (1), United States (5).|
721292|NCT02468648||
721293|NCT02468583||
721294|NCT02468570||Pooled Results: This is a sub-study of 165-302, with a randomized, placebo-control discontinuation design in Part 2. 9 subjects were enrolled in 165-303: 3 in 20mg/day and 3 in 40mg/day Active arm, 2 in 20mg/day and 1 in 40mg/day Placebo arm. Data interpretability was extremely limited, hence planned analysis was using the pooled treatment groups.
721295|NCT02468414||
721296|NCT02468193|Planned subjects: 10 subjects Actual enrolled: 9 subjects|Planned subjects: 10 subjects
721297|NCT02468154|Between November 2014-August 2015, 57 paediatric orthopaedic patients who need a lower limb plaster cast after surgery out of the 172 potentially eligible (33.1%) were enrolled in the trial.|
721298|NCT02467842||
721299|NCT02467777||
721300|NCT02467621||
721301|NCT02467504||
721302|NCT02467491||17 participants signed the informed consent, but only 12 participants started and completed the exercise intervention
721303|NCT02467465||
721399|NCT02458287||
721400|NCT02458235||
735895|NCT01411215||
721304|NCT02467387|34 patients have been screened for eligibility between June, 2014 and April, 2016 at Emory University Medical Center, Atlanta, GA, Northwestern University Medical Center, Chicago, IL, University of Pennsylvania Medical Center, Philadelphia, PA, and Stony Brook University Medical Center, Stony Brook, NY.|23 out of 34 patients have been randomized and 22 received the study intervention. Of those not randomized, 10 did not meet inclusion criteria and 1 could not tolerate CMR.
721305|NCT02467179||
721306|NCT02467075|Subjects were recruited from inpatients at a tertiary medical center who were scheduled to have a clinical CT for a suspected infection. Subjects had to have a previous diagnosis of Chronic Kidney Disease (CKD) Stage II or IIB and stable creatinine levels. Their physician had to agree to their participation in the study.|Patients had to be scheduled for a CT that did not have a) requirement for the CT scan to be performed with contrast agent or b) a contraindication against having the CT scan with contrast agent
721307|NCT02466958||
721308|NCT02466659||
721309|NCT02466646||Total of 54 subjects were assessed for eligibility. Prior to assignment of participants, 2 subjects declined to participate and 10 participants were not meeting inclusion criteria
721310|NCT02466555||Thirty-three participants with SCD were approached for recruitment. Three declined due to scheduling conflicts or disinterest. Thirty (90.9%) participants agreed to participate and completed written consent.
721311|NCT02466516|Participants were enrolled at study sites in United States and Canada. The first participant was screened on 08 June 2015.The last study visit occurred on 11 October 2016.|242 participants were screened.
721312|NCT02466425|The study was conducted at 36 sites in the United States between 18 June 2015 and 16 February 2016.|A total of 338 participants were screened and 264 participants were enrolled in the study.
721313|NCT02466412|"Study initiated (first subject screened): 08 May 2015
~On Day -3 (admission), after all inclusion/exclusion criteria were checked, all eligible subjects were enrolled and tried CHTP 1.1 M.
~From enrollment, they were asked to remain abstinent from smoking for at least 24 hours before being randomized on Day 1 into 1 of the 2 sequences."|"Number of subjects enrolled = 56, but only 48 were randomized as described below:
~Sequence CHTP 1.1 M then mCC: 24 subjects
~Sequence mCC then CHTP 1.1 M: 24 subjects
~Number of subjects enrolled but NOT randomized = 8"
721314|NCT02466399||
721315|NCT02466230|Participant Flow of the Overall Study.|28 subjects were enrolled and all completed the study.
721316|NCT02466087||
721317|NCT02465931|Participants were recruited through research registries and convenience samples|41 participants were excluded because they did not meet eligibility criteria
721318|NCT02465866|Twenty healthy subjects were enrolled in the study.|
721319|NCT02465632||
721320|NCT02465528||A minimum of 10 and a maximum of 20 subjects were to be enrolled in each arm (tumor type)
721321|NCT02465515|This was a randomized, double-blind, parallel group, placebo-controlled study in participants with Type 2 diabetes having a previous history of cardiovascular disease and not having optimal glycemic control.|A total of 10793 participants were screened of which 1330 failed screening and 9463 participants were randomized in a 1:1 ratio to receive either once weekly albiglutide or matching placebo subcutaneous injections. The study was conducted in 28 countries
721322|NCT02465489||
721323|NCT02465463|Participants were recruited June 2015 through November 2016.|
721324|NCT02465450||
721325|NCT02465437||
721326|NCT02465372||
721327|NCT02465216||
721328|NCT02465203||
721329|NCT02465099||
721330|NCT02465073||
721331|NCT02464917||
721332|NCT02464540||
721333|NCT02464176|Study run from June 2015 to January 2017 at Wake Forest Baptist Medical Center|Patients 18-90 years old undergoing primary elective total hip arthroplasty were eligible. Exclusion: contraindications to regional anaesthesia, peripheral neurologic dysfunction or neuropathy, diabetes mellitus, systemic corticosteroid use within 30-days of surgery, chronic opioid use, pregnancy, allergy or adverse reaction to dexamethasone.
721334|NCT02464163||
721335|NCT02464059|Dates of recruitment: 11/10/2015-11/15/2018|
721336|NCT02464033||
721337|NCT02463981||
721338|NCT02463487|The study population was comprised of patients who were admitted to hospital with a moderate or severe foot infection that required incision and drainage and parenteral antibiotics and for whom negative pressure wound therapy (NPWT) was indicated. Patients who fit the criteria for the study were then recruited.|"The patients underwent a screening exam including
~evaluating sensory neuropathy with loss of protective sensation with a 10-gram monofilament
~Vibration Perception Threshold Testing
~ABI - ankle brachial index
~SPP - skin perfusion pressure
~Peripheral arterial disease (PAD) was defined as either ABI <0.9 or SPP <30 mm Hg."
721339|NCT02463409||The screening visit included labs, physical exam and medical history, prior to assignment to the theophylline arm.
721340|NCT02463331||
721341|NCT02463227||
721342|NCT02463097||
721343|NCT02463071|This study was conducted in 26 sites in Japan between 10 June 2015 and 08 March 2017.|The study duration was up to 60 weeks, consisting of an initial screening period of 8 weeks and a 52-week treatment period.
721344|NCT02463032||
721345|NCT02462967||
721346|NCT02462928||
721347|NCT02462876||
721348|NCT02462759|Participants were recruited from sites in the US and Germany. Part 1 was terminated early as positive efficacy results were observed in interim analysis of study NCT02193074 and it was considered unethical to continue this part of study. Part 2 was also terminated early to rollover and continue to follow participants in study NCT02594124.|Total of 21 participants with SMA were randomized in Part 1 of the study(7 participants in sham procedure group,14 participants in ISIS 396443 group).1 participant died in sham procedure group of Part 1.Total of 20 participants were enrolled to receive ISIS 396443 in open-label phase of Part 2.Integrated analysis was performed for Part 1 and 2.
721349|NCT02462720||
721350|NCT02462486||
721351|NCT02462473||The study had a planned enrollment of approximately 155 participants into 3 cohorts. However a total of 9 participants were enrolled and analyzed for efficacy and safety assessments in Cohort 1 and no participants were enrolled into Cohorts 2 or 3 of the study.
721361|NCT02461771|Male and female subjects aged at least 50 years with the presence of an active choroidal neovascular lesion secondary to age-related macular degeneration were recruited to this Phase 1 open-label, single-dose escalation study at 4 study centers in the United States and Australia.|Subjects had received at least 3 anti-vascular endothelial growth factor treatments over the 26 week period prior to screening, and were enrolled into 1 of 3 cohorts to receive pegcetacoplan (previously known as APL-2). If both eyes were eligible for the study, the subject and Principal Investigator chose the eye that served as the study eye.
721362|NCT02461758||
721363|NCT02461693||
721364|NCT02461628|A total of 40340 participants signed consent. This is a cluster randomized trial with repeated measures; the repeated measures are independent cross-sectional samples of the population in each cluster. Participants at different time points are different participants who signed separate consent forms.|After enrollment, 7365 participants with a fever who received a malaria test from any source were approached to complete the survey. Only those 7365 participants are considered Started. Baseline data collection occurred before randomization of clusters to the arms.
721365|NCT02461589|"The trial was conducted at 139 sites in 10 countries as follows:
~Austria: 3 sites; Canada: 8 sites; Czech Republic: 9 sites; Germany:
~7 sites; Malaysia: 5 sites; Russian Federation: 7 sites; Serbia: 9 sites; South Africa: 7 sites; United Kingdom: 13 sites; United States: 71 sites."|Of the 706 subjects randomised in the trial, 705 were exposed to trial products and 1 randomised subject withdrew prior to exposure.
721366|NCT02461563|Males or females of non-child bearing potential with verified Genotype 1 (GT1) or Genotype 3 (GT3) Hepatitis C Virus (HCV) infection, between the ages of 18 and 65 years (inclusive) were enrolled in this trial.|GT1 and GT3 participants planned to receive 200 mg MK-1075 were not treated based on available data from previous studies.
721367|NCT02461550||
721368|NCT02461433||
721369|NCT02461355||
721370|NCT02461290||
721371|NCT02461160|Participants took part in the study at 1 investigative site in the United States from 12 May 2015 01 Aug 2016.|Healthy participants were enrolled to receive TAK-915 in any of the 5 parts of the study.
721372|NCT02461134|11 subjects were screened at 5 different sites. 1 subject was finally recruited into the study. The study was prematurely terminated due to poor recruitment.|The protocol-defined study population included male and female subjects aged 18 to 70 years with chronic Graft versus Host disease (GVHD). It was planned to recruit 30 subjects.
721373|NCT02460991||
721374|NCT02460978|The results on this form are from the 24 week short-term double-blind treatment period. This study was conducted at 148 centers in 13 countries from 8 July 2015 to 2 Sep 2017.|815 participants were randomized. Of the 195 participants not randomized: 97 No longer met study criteria, 44 withdrew consent, 13 were lost to follow-up, and 41 did not continue for other reasons. Two participants did not receive any study drug and were excluded from analyses. Thus, the total number of subjects is 813.
721375|NCT02460822||
721376|NCT02460679||
721377|NCT02460575||
721378|NCT02460562|Recruitment of subjects was carried out through hospital media from three government hospitals; Krathum Baen Hospital, Samut Sakhon Province, Health Promotion Center Region 1, Bangkok and Thammasat University Hospital, Pathum Thani Province. Subjects who were interested in the study could register directly at the dental clinic.|Subjects who registered for a screening appointment at the dental clinic were asked to complete a questionnaire and underwent an oral screening and a simple test of salivary flow rate at the screening visit. The subjects who met eligibility criteria were asked whether or not they would agree to participate in the study.
721379|NCT02460458|Recruitment Period: November 2012 - March 2015|
721380|NCT02460380||A total of 93 women were screened for vitamin D deficiency. Sixty-eight women were diagnosed with vitamin D deficiency and were included in the study and randomly allocated into the two groups.
721381|NCT02460263|Patients were enrolled at 8 dialysis centers throughout the U.S.|A run-in period of 1 week (4 hemodialysis treatments) was required on the Tablo Hemodialysis System prior to the first period.
721382|NCT02460198|This study was conducted at 34 clinical sites in 10 countries.|Participant flow as per the database cutoff date of 09SEP2019.
721383|NCT02460172|This is a split person study where one knee is assigned Zip, the other knee is assigned Staples. 50 knees were closed on 25 participants.|
721384|NCT02460159||
721385|NCT02459951||
721386|NCT02459899|The study was conducted at 17 centers in the United States from 10 July 2015 to 26 August 2016.|207 participants were screened and 141 participants with Type 1 diabetes mellitus who had inadequate glycemic control with insulin therapy alone, were randomized equally into four treatment groups: sotagliflozin 75 milligrams (mg), sotagliflozin 200 mg, sotagliflozin 400 mg or placebo.
721387|NCT02459665|The target population was women at high risk of urogenital infections living in Kigali, Rwanda. Recruitment activities were implemented by study staff with the help of Community Mobilizers, who were selected due to their strong connections with high-risk women in Kigali. They helped staff organize recruitment meetings in relevant communities.|At the end of the screening process, women were either ineligible or diagnosed with bacterial vaginosis (by modified Amsel criteria and/or Nugent score) and/or trichomoniasis (by culture or wet mount) and treated with 500 mg oral metronidazole 2x/day for 7 days. An enrollment visit was scheduled within three days after treatment completion.
721388|NCT02459418|This was a Phase 1, randomised, open label, 2-period, 2-treatment, crossover study in healthy female subjects. 42 subjects were randomised to receive either AFOLIA on study day 1 and Gonal-f® RFF on study day 27 or Gonal-f® RFF on study day 1 and AFOLIA on study day 27.|Screening was conducted at more than 1 visit to the clinical unit during study days -28 to -1 to allow completion of all assessments. Only subjects taking oral contraception for at least 3 months could enter the study. Subjects were required to stop taking their regular oral contraceptives so they could receive LupronDepot®.
721389|NCT02459275||
721390|NCT02459197||
721391|NCT02459119||
721392|NCT02459093||
721393|NCT02459080||
721394|NCT02458768||
721395|NCT02458690||
721396|NCT02458469|Participants were recruited to the primary site at John D. Dingell VA Medical Center.|Of 1257 available, 15 participants were enrolled. Of the 15 enrolled, 11 started the study protocol.
721397|NCT02458365||
721398|NCT02458352||
721407|NCT02457637|Only INPATIENTS who met inclusion criteria were recruited.|Did not meet inclusion criteria (n = 1,306) ;Age <15 years or ≥80 years (n = 36);Pregnant (n = 22);Liver malignancies (n = 514);Malignancies in other organs (n = 77);Severe chronic extrahepatic disease (n = 107);Received immunosuppressive drugs for reasons other than chronic liver disease (n = 21);Withdrew informed consent (n = 73);Other (n = 205)
721408|NCT02457611|Participants were enrolled at study sites in Germany and the United Kingdom. The first participant was screened on 11 June 2015. The last study visit occurred on 8 January 2016.|34 participants were screened.
721409|NCT02457546|Subjects were recruited from medical centers in North America, Europe, and Asia-Pacific. The first subject was randomized on July 7 2015 and the last subject completed the study October 12 2017|
721410|NCT02457325|50 patients were recruited to perform bilateral surgery for extraction of lower third molars, at the Faculty of Dentistry of Bauru|46 of 50 patients were randomized. Of those not randomized, 4 did not return to folow up and were excluded of the study.
721411|NCT02457260||
721412|NCT02457247|Participants took part in the study at 9 investigative sites in the United Kingdom and Germany from 02 June 2015 to 27 August 2015.|"Participants eligible for Vitamin D and Calcium supplements were enrolled equally in 1 of 2 Test Groups to determine the preference between 2 treatments.
~Group 1: Calcichew D3 500/400 and Adcal-D3 600/400 or Group 2: Calcichew D3 500/800 and Kalcipos-D 500/800."
721413|NCT02457195||
721414|NCT02457182||
721415|NCT02457065|Survivors of primary cutaneous melanoma less than 4.0 mm in depth who came through the Dermatology Clinic at Dartmouth-Hitchcock Medical Center and voluntarily chose to participate in the study after being informed of the nature of the research.|All enrolled participants were assigned to arms/groups. None were excluded from the study.
721416|NCT02456896|June 2015 to December 2015 Psychiatry outpatient department|Out of 40 bipolar mania patients screened, 12 patients were excluded as they did not meet the inclusion criteria and another three patients declined to participate. For recruitment of healthy controls, 35 subjects were screened and after exclusion of 10 subjects, 25 were included in the study.
721417|NCT02456740|"This study was conducted at 121 centers in Canada, Austria, Belgium, Czech Republic, Finland, Germany, Poland, Slovakia, Sweden, the United Kingdom, Turkey, the Netherlands and USA.
~The study consisted of a 24-week double-blind treatment phase and a 28-week active treatment phase."|"At the end of the baseline phase, participants were randomized 1:1:1 to receive placebo, erenumab 70 mg, or erenumab 140 mg monthly for 24 weeks. Randomization was stratified by region and treatment status with migraine prophylactic medication.
~Participants were re-randomized at week 24 to erenumab 70 mg or 140 mg for 28 weeks."
721418|NCT02456727|Participants were referred by their primary care providers (PCPs) from their participating health care center. For patients who met the eligibility criteria, PCPs completed a study-specific referral form and obtained permission to contact the patient by phone. Participants were then contacted by the study staff and screened for eligibility.|Participants were screened by phone and completed an oral consent. They were mailed a treatment consent form and told to contact the study team in order to complete the baseline and receive their treatment arm. Several participants were excluded for various reasons including ineligibility and declining participation.
721419|NCT02456662||757 participants were screened. 438 were excluded because they were not eligible or declined to participate. 319 were randomized to either placebo or Ondansetron.
721420|NCT02456636|Patients from 36 medical practices were recruited via mailings and in-clinic referrals. Initial eligibility was assessed via telephone screen. Patients then completed a baseline survey, physician clearance was documented, and finally BMI was verified at the initial study visit. The recruitment period was from 2/15/2016 through 10/2/2017.|
721421|NCT02456103||All eligible participants, including those who received placebo in the double-blind study (PTC124-GD-021-CF; NCT02139306), were enrolled to this open-label extension study. To avoid interruption in treatment, when possible, Screening/Baseline for this extension study was to occur on the same day as the End-of-Study visit for the double-blind study.
721422|NCT02455518||
721423|NCT02455453||
721424|NCT02455388||No significant events took place in the study after enrollment but prior to arm assignment.
721425|NCT02455336||
721426|NCT02455076|Participants for outpatient part of the study were recruited from participants completed inpatient part of the study. 103 (out of 145 participants who complied inpatient trial) consented to be randomized into one of the two outpatient arms.|
721427|NCT02455050||
721428|NCT02454959|This is a randomized, 2-period, open-label, chronic dosing (7 days), cross-over study conducted at 8 sites in the US.|Subject received one week of study treatment for each of the treatment periods, separated by a washout period of 7-14 days between treatments. Intent-to-treat (ITT) Population is used for Participant Flow. By-sequence tabulations of the data were not pre-specified.
721429|NCT02454933|Subjects were recruited to this study in 9 centres in South Korea, Canada and Taiwan. First subject first visit: 26 August 2015. Data is presented up to the primary analysis data cut-off date of 21 August 2017.|60 subjects with a confirmed diagnosis of Epidermal Growth Factor Receptor (EGFR) T790M mutation postive non-small cell lung cancer (Stage IIIB-IV) with progression following prior therapy with an approved EGFR tyrosine kinase inhibitor agent were screened, and 29 were assigned to treatment.
721430|NCT02454608||
721431|NCT02454530|Between September 2014 and September 2016, 102 public and/or private hospital-based oncologists included 1160 patients with solid tumor treated with cytotoxic chemotherapy and for whom a prophylactic treatment with G-CSF (Granulocyte Colony-Stimulating Factor) biosimilar (Nivestim®) was initiated. The study was conducted in France.|
721432|NCT02454478|Participants took part in the study at 3 sites in Japan from 01 July 2015 to 29 May 2017.|A total of 9 participants were screened, of which 7 were enrolled and treated in the study.
721433|NCT02454296|Participants recruited from May 2015 to Dec 2015 at two of the faculty practice offices of the University of Hawaii Department of OB/gyn.|
721434|NCT02454283||
721435|NCT02454179||
721436|NCT02454127||
721437|NCT02454101|The current RCT was conducted at Ain Shams University Maternity Hospital during the period between August 2015 to February 2016|No significant events following participants recruitment
721438|NCT02453841||
721439|NCT02453750||
735898|NCT01410812||
735899|NCT01410799||
721440|NCT02453711|The trial was conducted at 71 sites in 8 countries as follows: Australia: 5, Belgium: 5, Canada: 9, Germany: 6, Israel: 7, Russian Federation: 10, United Kingdom (UK):8, United States (US): 21. Along with this, recruitment of participants was planned at 3 sites (1 each in Germany, Russian Federation, and US), but where no participants were screened|Design:Participants were randomised to 1 of the 16 parallel treatment arms in a 6:1 ratio (active:placebo) to receive either:A)Semaglutide 0.05/0.1/0.2/0.3/0.4 mg; dose escalation every 4th week B)Semaglutide 0.3/0.4 mg; dose escalation every second week C)Liraglutide 3.0 mg;dose escalation every week D)Placebo;matching each of the active treatment
721441|NCT02453685|The trial was conducted at 41 sites in 9 countries, as follows: Australia: 4 sites; Bulgaria: 5 sites; Hungary: 3 sites; India: 7 sites; Korea, Republic of: 4 sites; Serbia: 5 sites; Thailand: 4 sites; Turkey: 5 sites; United Arab Emirates: 4 sites.|
721442|NCT02453672||
721443|NCT02453581||
721444|NCT02453555||
721445|NCT02453386|This study was conducted at 80 sites in 7 countries. Planned patient enrollment numbers were achieved, but the study and the tozadenant development program were terminated prior to study completion by all patients, based on an unexpected emerging safety signal as discussed in the safety sections of this report.|
721446|NCT02453360||
721447|NCT02453347||
721448|NCT02453321|Patients presenting for Total Knee Arthroplasty (TKA) at University of Pittsburgh Medical Center (UPMC) - Passavant Hospital were approached on the day of surgery, but some were called the day prior to surgery.|No patients were enrolled but excluded prior to assignment to a randomized group.
721449|NCT02453282|A total of 194 centers across 17 countries in Asia, Australia, Europe and North America randomized adults with epidermal growth factor receptor and anaplastic lymphoma kinase wild-type advanced or metastatic non-small cell lung cancer in this study. First participant was randomized on 14 August 2015 and final data cut-off date was 04 October 2018.|A total of 1118 participants were randomized in a 1:1:1 ratio in stratified manner as per programmed cell death ligand 1 (PD-L1) tumor expression status (PD-L1 [tumor cell (TC) >=25%] versus (Vs) PD-L1 [TC <25%]) and histology (squamous Vs non-squamous) to receive durvalumab alone, durvalumab + tremelimumab, or standard of care (SoC) chemotherapy.
721450|NCT02453256||Overall 212 participants were randomized on to the study, 107 to the placebo arm and 105 to the tocilizumab arm. One participant in placebo arm withdrew consent prior to receiving any treatment and one participant in the tocilizumab arm was withdrawn due to randomization error prior to receiving any treatment.
721451|NCT02453191||
721452|NCT02453113||
721453|NCT02453048||
721454|NCT02452944|dates of the recruitment period: January 2015 - May 2015 types of location: in the operating room|
721455|NCT02452931||
721456|NCT02452892|12clinical study sites in the US recruited 122 subjects that were randomized into the study. The date of first subject enrollment was 03 September 2015 and the date of last subject enrolled was 22 July 2016.|Subject screening period was up to 14 days before receiving first study treatment. Subjects were contacted by an independent Massachusetts General Hospital-Clinical Trials Network and Institute (MGH-CTNI) rater to perform the Antidepressant Treatment Response Questionnaire (ATRQ) and SAFER assessments to confirm eligibility.
721457|NCT02452554|Each of 6 disease strata enrolled up to 16 patients who were evaluable for the primary response criteria.|
721458|NCT02452528||
721459|NCT02452463||"No participants were enrolled in the Arm III (Nintedanib, Durvalumab) Arm - study closed prior to any patients being enrolled in this arm."
721460|NCT02452424|"Dose Escalation: 33 participants who met the inclusion and none of the exclusion criteria were enrolled and received study drug.
~Dose Expansion: 45 participants with melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, squamous cell carcinoma of the head and neck (SCCHN), and gastrointestinal stromal tumor (GIST) were enrolled."|"Dose Escalation: Up to 42 participants with advanced solid tumors (any type) were to be enrolled sequentially in up to 7 cohorts (3+3 design).
~Dose Expansion: Up to 483 participants were planned with the sample size for each tumor type based on a truncated sequential probability ratio test (max sample size 28 to 48 participants per tumor type)."
721461|NCT02452398|The study was terminated and no results analysis was done.|
721462|NCT02452359||Each subject to receive IPL 580 nm treatment to striae distensae on either abdomen or thighs. Baseline photos taken of untreated treatment area.
721463|NCT02452346||
721464|NCT02452320||"136 subjects were informed of and consented to participate. Due to unforeseen scheduling conflicts and canceled surgeries, we recruited more subjects in order to reach our 128 recruitment mark for statistical analysis.
~1 subject was not included in the analysis due to a prolonged hospitalization not related to the study."
721465|NCT02452190||A total of 1159 participants were screened, of whom 468 participants were eligible and enrolled in a 3-week run-in period for self-monitoring. All 468 enrolled participants were then randomized at 201 centers in 20 countries.
721466|NCT02452060||
721467|NCT02452047|Adult participants with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), or complicated urinary tract infection (cUTI) were recruited at 35 study centers in 17 countries.|
721468|NCT02452034|Immunocompromised participants aged 2 to 17 years old, with neutropenia expected to last for at least 7 days following start of study treatment, were enrolled in this study.|
721469|NCT02451995||22 were excluded. This was due premature termination of AT whilst mapping (n=6), AT non-inducibility (n=9), or degeneration to alternating ATs/atrial fibrillation prior to the delivery of ablation (n=4). Left atrial appendage thrombus on Trans Oesophageal Echo seen at the start of the procedure (n=3) resulted in immediate procedural cessation.
721470|NCT02451943||Completers include participants who died or alive and on study at conclusion, but off treatment.
721471|NCT02451930||Per protocol, participants in Part A Cohort 2 who received the recommended necitumumab dose for Part B were also analyzed together with Part B.
721472|NCT02451917||
721473|NCT02451839||Of the 168 recruited participants, 4 withdrew or were withdrawn prior to baseline measures being completed (164 participants had baseline World Health Organization Disability Assessment Schedule [WHODAS] data recorded).
721736|NCT02428413|Patient screening took place in the day surgery unit at Memorial Hermann Hospital in the Texas Medical Center of Houston Texas between July 2015 and November 2015.|
721474|NCT02451670|All patients with an adult primary care visit with a primary care provider in a randomized clinic were assessed for study eligibility. After entry of blood pressure data, relevant health record data were automatically extracted, encrypted and processed through Web-based clinical algorithms that determined eligibility.|
721475|NCT02451514|Subjects were recruited from 5 sites in Panama, 3 sites in Colombia and 1 site in Chile.|Healthy adolescents and young adults, who received 2 doses of MenABCWY+OMV vaccine or 1 dose of MenACWY in the parent study V102_02 (NCT01210885) and only Tdap vaccination in study V102_02E1 (NCT01367158) were included in the present study along with Naive subjects of similar age.
721476|NCT02451488||
721477|NCT02451358|Study participants were enrolled in 8 centers in India from 27 July 2015 to 26 November 2016.|A total of 400 participants (100 in each group) were enrolled and vaccinated in the study.
721478|NCT02451202||
721479|NCT02451150|Participants took part in the study at 3 investigative sites in Japan from 6 August 2015 (first participant signed informed consent) to 10 September 2015.|Participants with a diagnosis of hypertension were enrolled in 1 of 2 treatment groups, TAK-536 (azilsartan) 5 mg or 10 mg based on weight.
721480|NCT02451137|The study was conducted at 427 sites in 2 countries. A total of 4989 participants were screened between 16 June 2015 and 14 July 2017, of which 1684 were screen failures. Screen failures were mainly due to inclusion criteria not met.|Out of 3305 participants, 1 participant was not randomized, but received treatment; hence not included in any analysis (baseline, efficacy and safety). Assignment in arms was done centrally by interactive response technology (IRT) in 1:1 ratio.
721481|NCT02451124||
721482|NCT02451007|This study was nested into a multicenter clinical trial with a competitive recruitment. From August 2015 to June 2016, a total of 39 evaluable patients at 12 sites in USA and Spain were included in this QT evaluation study with baseline and one or more postbaseline Electrocardiogram (ECG) assessments available.|
721483|NCT02450903|Approximately 20 patients were planned to be enrolled.|A total of 20 patients were enrolled and treated with ceritinib.
721484|NCT02450799|Subjects were recruited from 11 study centers located in Japan.|Of the 104 enrolled, 6 subjects were exited as screen failures and deemed ineligible for participation. This reporting group includes all eligible subjects (98).
721485|NCT02450747||Forty-four (44) subjects were enrolled in this study. Five (5) subjects did not meet the eligibility and were not dispensed a study article. Of the 39 subjects dispensed study lenses all subjects completed the study without any major protocol deviations.
721486|NCT02450591||
721487|NCT02450578|A total of 40 subjects were screened. Of these 22 (55.0%) were enrolled to participate in the study|"One subject was allocated to treatment but did not receive any study medication due to an ECG abnormality discovered after randomization and, therefore, 21 out of 22 subjects received at least one dose of the study medications.
~In agreement with the Safety Review Team, the Sponsor decided to close the study without progressing to conduct Cohort 3."
721488|NCT02450552||
721489|NCT02450539||Participants who completed were those who died due to any cause.
721490|NCT02450526|This was a multicentre, phase III, randomised, double-blind (DB) then open-label (OL) study. The 12 month recruitment period began in April 2015. A total of 555 subjects were screened across the 10 study centres in China and 520 subjects were randomised into the study.|The 35 screen failures were due to 17 subjects not meeting the eligibility criteria, 17 subjects withdrawing consent, and one subject reporting an adverse event.
721491|NCT02450487||
721492|NCT02450383|Recruitment started in January 2015 and was finalized in May 2016|
721493|NCT02450331||
721494|NCT02449915||
721495|NCT02449902||
721496|NCT02449889|A total of 4 sites in Brazil randomized subjects to the trial.|In total 245 subjects were screened. Of these, 69 were screening failures and 176 were randomized. All randomized subjects were exposed to investigational medicinal product (IMP).
721497|NCT02449798||
721498|NCT02449473|First patient enrolled: 29 Sep 2015; Last patient last visit: 21 Jun 2017. Study performed at 14 sites in 3 countries. Patients maintained on currently prescribed inhaled corticosteroid (≥250 micrograms fluticasone dry powder formulation equivalents total daily dose) + any additional maintenance asthma controller medication throughout the study.|79 patients were randomised to receive investigational product (IP) and all those randomised received treatment.
721499|NCT02449434|Participants (n = 600) aged 18 years or older, were recruited between May 2014 and March 2016 following referral by their general dental practitioners (GDP) for erosive tooth wear (cases, n = 300) or general treatment (controls, n = 300) to the restorative clinics at King's College London Dental Institute.|
721500|NCT02449356|We have 80 adult patients as candidates who were undergoing the neurosurgery or spinal surgery in Xiangya Hospital affiliated to Central South University between Mar 11, 2014 and Mar 16, 2016. These participants were graded American society of anesthesia(ASA)I-II,and aged 30-70 years old,weighted ranging from 50 to 75 kilograms.|We finally enrolled 60 patients for our trail. Among the 80 candidates, 7 patients couldn't meet our inclusion criteria; the other 13 patients refused to participate in this trail at last.
721501|NCT02449291||
721502|NCT02449174||One patient who enrolled never started treatment.
721503|NCT02449044|The trial was conducted in 111 enrolled participants at 33 trial centers. This is an extension study of trials NCT00072683 and NCT00201994. Approximately 50% participants may have been on tolvaptan previously, there was a minimum 7-day period off treatment between trials.|Participants were blinded prior to treatment with tolvaptan with titration between target doses of 15mg, 30mg or 60mg of study drug was based on the participant's response in serum sodium concentration and clinical tolerance of study drug. Dose titration aim was to stabilize the participants with normal range of blood sodium.
721504|NCT02449018||
721505|NCT02448914||
721506|NCT02448875|Subjects were recruited from 6 study centers located in Germany (3), Poland (1), Spain (1), and Panama (1).|Of the 192 enrolled, 49 subjects were exited prior to randomization. In addition, one randomized subject discontinued prior to treatment. This reporting group includes all treated subjects, Dose Selection Phase and Expansion Phase (142 subjects).
721507|NCT02448862||
721621|NCT02438540||43 participants took part in trial. 4 of them were excluded from the trial according to including and excluding criteria. At last, 39 participants were distributed by permuted-block randomization.
721508|NCT02448810|The study was conducted at 21 centers in the United States, the United Kingdom and Spain between 15 June 2015 (first participant first visit) and 15 February 2017 (last participant last visit).|Overall (part 1 and 2) 115 participants were screened, 85 participants were randomized and 79 participants were treated. In part 1, 17 participants were screened, 5 failed screening, 12 were randomized and treated. In part 2, 98 participants were screened, 17 failed screening and 8 did not start the study, 73 were randomized and 67 were treated.
721509|NCT02448719|Participants took part in the study at 1 investigative site in Japan from 27 May 2015 to 28 January 2016.|Healthy Japanese participants received TAK-792 or placebo in Cohort 1a (30 milligram [mg]), Cohort 2a (100 mg), Cohort 3a (250 mg), Cohort 4a (500 mg), Cohort 5a (750 mg), and Cohort 6a (1250 mg). Healthy Caucasian participants received TAK-792 or placebo in Cohort 4b (500 mg), Cohort 5b (750 mg) and Cohort 6b (1250 mg).
721510|NCT02448706||
721511|NCT02448680||
721512|NCT02448654||36 consented to be in the study, completed a baseline session, and were randomized to a study arm. However, 4 subjects never actually began the medication trial (i.e., stopped participating prior to receiving any pills (tolcapone or placebo)). 32 subjects began the pill portion of the trial (i.e., started tolcapone or placebo).
721513|NCT02448641||
721514|NCT02448563||"Participants were considered enrolled when they signed the informed consent form. From the time of enrollment to intervention start, 66 participants either withdrew from the study or became lost to follow-up."
721515|NCT02448537||
721516|NCT02448368|35 participants were randomized|Twenty subjects were randomized to 1 of 10 treatment sequences in Cohort 1 with single doses. Fifteen subjects were randomized to 1 of 3 treatment sequences (IJK, JKI, and KIJ) in optional Cohort 3, with single doses occurring on Days 1, 5, and 9. The optional Cohort 2 to evaluate RDEA3170 capsules, 5 mg FN23 was not conducted per Sponsor decision.
721517|NCT02448303||
721518|NCT02448043|Subjects were recruited voluntarily from private office practices (DP and AS), and a university-based practice (AT).|
721519|NCT02447952|This is an exploratory, non-controlled, non-drug study in participants with amyotrophic lateral sclerosis (ALS). The study enrolled participants using two sites based in the United Kingdom|Of total 25 screened participants, 5 participants were included in pilot phase of which 2 completed and entered core study phase with other 23 participants.
721520|NCT02447926|Recruitment of the study subjects will be made from the End Stage Liver disease patients attending the outpatient pre-transplant clinics of the Northwestern Comprehensive Transplant Center.|
721521|NCT02447887||
721522|NCT02447848||
721523|NCT02447575||
721524|NCT02447497||"This is a randomized, paired-comparisons design where each subject will receive the two planned treatments, one on the left side of body and one on the right.
~Each subject provides 2 abdomen test sites, left or right, and 2 inguen test sites, left or right. Therefore 25 subjects provide 100 potential test sites."
721525|NCT02447458|Participants took part in the study at 1 investigative site in the United States from 19 August 2013 (first participant signed informed consent form) to 05 February 2014.|Healthy volunteers were enrolled in 1 of 5 MLN3126 ascending dose treatment groups: once a day 300 mg, 600 mg, 1000 mg under fed or fasting conditions,1500 mg or 2000 mg OR once a day placebo.
721526|NCT02447432|Two epochs were defined in the study. The duration of the study was for Epoch 001: Primary starting at Month 0 and ending at Month 4 and for Epoch 002: Booster starting at Month 8 and ending at Month 9. 5 subjects did not participate to the Epoch 002 (none due to an serious adverse event)|
721527|NCT02447328|"First subject enrolled: 29MAY2015 Last subject last visit: 06MAY2016
~This study was conducted from 29 May 2015 to 06 May 2016 and 85 subjects from 9 study centres participated."|"Visit 1 (Enrolment visit) Obtained ICF and Eligibility check
~Duration of treatment with Fulvestrant (Faslodex®):
~Study drug administered biweekly at first cycle. Afterward, Study drug administered monthly. (expected duration of treatment: 6 cycles)
~End of Study post dose follow-up visit after study drug discontinuation."
721528|NCT02447250||1 subject was consented into the study, but then became too clinically unstable to participate in the study and remained unstable throughout the eligibility period.
721529|NCT02447133||
721530|NCT02447081|A total of 1088 subjects were enrolled and attempted implant with Amulet left atrial appendage occluder conducted at 61 sites between June 01, 2015 and September 19, 2016. The final study visit at 2 years post-implant was completed by 864 subjects, with the last study visit occurring in October 2018.|
721531|NCT02447029||
721532|NCT02447003||"Per protocol, response or progression during the second pembrolizumab course was not counted towards efficacy outcome measures, and adverse events during the second pembrolizumab course were not counted towards safety outcome measures.
~Based on protocol-specified inclusion criteria and outcome analyses requirements, Part 2 was not conducted."
721533|NCT02446990|A total of 1181 centres in 51 countries screened at least one patient and 1139 centres included at least one patient.|A total of 23 164 patients were screened, 21 862 were selected and 19 107 were included. The Randomised Set comprised 19 102 patients: 9550 patients in the ivabradine group and 9552 in the placebo group. Of the 19 102 patients in the Randomised Set, 17 724 completed the study: 8830 patients in the ivabradine group and 8894 in the placebo group.
721534|NCT02446912|Participants took part in the trial at 123 sites in 18 countries worldwide.|
721535|NCT02446899|Participants took part in the trial at 119 sites in 15 countries worldwide.|8 participants were assigned study drug, but due to non-compliance were analyzed separately (not included in the participant flow). 3 additional participants were assigned study drug & included in the participant flow, but did not receive study drug due to an adverse event (1 Anifrolumab 300mg) & failure to meet randomization criteria (2 Placebo).
721536|NCT02446847||
721537|NCT02446769||
721538|NCT02446743|Subjects were recruited from 4 sites in Australia,6 sites in Canada & 2 sites in Chile.Analysis were performed on the study population (Groups 3B and B_0_1), but also repeated & stratified by parent study (i.e., V72_41 subjects using naïve subjects in Australia and Canada as controls, and V72P10 subjects using naïve subjects in Chile as controls)|All enrolled subjects were included in the study. Only groups 3B & B_0_1 were accounted for enrollment number as subjects from parent studies are included in the group 3B.
721539|NCT02446717||This study included a 42-day screening period.
721622|NCT02438475||
721623|NCT02438423||
721541|NCT02446613|Participants (par) of All subjects population (ASP) from study TL7116958 who passed screening for study 204509 were used as safety population for this study. All outputs using information from study TL7116958 were analyzed using ASP and stand alone outputs for this study were analyzed using Safety population.|Participants with respiratory allergy/allergies, with or without asthma, who completed the parent study TL7116958 in 2014 were enrolled to investigate the long term effect of previous treatment with GSK2245035 compared to placebo on total nasal symptoms (sym.) elicited by allergen challenge.
721542|NCT02446496|Total of 24 participants were enrolled in from March-2014 to April-2014. During each study period participants received test (treatment A-cefadroxil tablet) and reference (treatment B-cefadroxil tablet) products.|Total of 28 participants were screened, out of which 4 were screen failure. Of 4 participants, 1 withdrawn due to significant variation in laboratory results and 3 withdrawn upon their will.
721543|NCT02446483|The study was planned on 60 adult healthy male and female participants, aged 18 to 55 years, at a single site of Egypt from 30 January 2014 to 27 October 2014. During each study period participants received test (treatment A- rabeprazole tablet) and reference (treatment B-rabeprazole tablet) products.|Out of 64 participant screened, one participant was excluded because of significant variation in laboratory results and three participant withdrew the consent, remaining 60 were included in period I.
721544|NCT02446418|A total of 439 participants with persistent asthma were screened. The study was conducted at 63 centers in 2 countries: 43 in France and 20 in Germany from 09 July 2015 to 20 July 2017. Age value being reported for all participants is an approximate age accurate to within + or -1 year.|A total of 439 participants were screened for this study and 423 participants were randomized to treatment. Three of the randomized participants did not receive study treatment and were not included in the Intent-To-Treat (ITT) population.
721545|NCT02446314||
721546|NCT02446223||
721547|NCT02446171|This study was conducted at PAREXEL International, Early Phase Clinical Unit Berlin, Berlin, Germany.|Participants were randomized in 4 sequence Williams design for 4 periods and 4 treatments: 25 mg naloxegol tablet crushed and suspended in water taken orally(Treatment A), 25 mg naloxegol tablet crushed and suspended in water via nasogastric tube (Treatment B), 2.5 mg/mL oral solution (Treatment C) and 25 mg naloxegol tablet swallowed(Treatment D).
721548|NCT02446015|Subjects were recruited from 6 study centers located in the US and 2 study centers located in Australia.|Of the 159 enrolled, 58 subjects were exited as screen failures prior to randomization. An additional 4 subjects were randomized in error and did not receive investigational product (IP). This reporting group includes all treated subjects (97).
721549|NCT02445963||
721550|NCT02445911||
721551|NCT02445859||
721552|NCT02445807||
721553|NCT02445794||
721554|NCT02445755||
721555|NCT02445625|A total of 15 (plus 3 in case of drop outs) participants will be recruited. We expect to recruit one subject each three weeks. We recruited the first participant on the second semester of 2015 and the study last up to 82 weeks (including follow-up).|
721556|NCT02445586||
721557|NCT02445573|Participants were recruited through posters and specialist's recommendations in Guang'anmen hospital of China Academy of Chinese Medical Sciences, Beijing, China, from December 2012 to June 2014.|A total of 181 women with UI were invited to participate in the study. 101 women were excluded from the trial before assignment to groups, of whom 87 did not meet inclusion criteria, 10 declined to participate, 4 were afraid of acupuncture. 80 women were eligible and randomly assigned to EA group (n=40) or sham EA group (n=40).
721558|NCT02445326||
721559|NCT02445287||
721560|NCT02445196||
721561|NCT02445027|A total number of 60 Participants were enrolled in the study|
721562|NCT02445014||"In this study we were trying to establish how many participants can provide us with quality imaging using this new technology. Therefore we treated them as one group. 2 healthy subjects and one with BE were enrolled.
~Upon reviewing imaging data it was concluded that this new technology is not optimal for the study and the enrollment was stopped."
721563|NCT02444988||"For randomization, we will generate two sequences of study group assignment ([1] saline during odd-numbered months and balanced crystalloid during even-numbered months; [2] balanced crystalloid during odd-numbered months and saline during even-numbered months).
~Participants will only receive 1 of the 2 interventions."
721564|NCT02444936||
721565|NCT02444793||
721566|NCT02444715||
721567|NCT02444533|Subjects were recruited at the Mayo Clinic in Rochester, Minnesota.|
721568|NCT02444234||This was a cross-over study where patients with CF received tedizolid 200mg IV or PO once daily for 3 doses followed by a minimum 2 day washout and receipt of the remaining dosage form.
721569|NCT02444182||"Inclusion criteria of the study:
~healthy subject with no history of systemic antibiotics or topical fluoride treatments within the 4 weeks prior to baseline
~subject who agrees to suck lozenges containing probiotics twice a day.
~subject who agrees to stop taking any other probiotic containing products during the study period"
721570|NCT02444143||
721571|NCT02443883||Study completion was defined as death due to any cause or disease progression.
721572|NCT02443805|This study was conducted between 29 September 2015 (first patient, first visit) and 25 June 2018 (last patient, last visit).|2,174 (50.9%) and 486 (11.4%) patients were excluded before and during the placebo run-in period, respectively. The main reason for screen failures at these two stages was a failure to meet randomization criteria.
721573|NCT02443792||
721574|NCT02443740||The study consisted of 4 cohorts. Cohort 1 and 2 was a 4 period crossover sequence of PF-05251749 and matching placebo. Cohort 3 was designed to characterize the pharmacokinetic (PK) of PF-05251749 in cerebrospinal fluid (CSF) samples. Cohort 4 was a 2 period crossover sequence of unmilled and milled PF-05251749.
721575|NCT02443688||
721576|NCT02443571||
721577|NCT02443519||
721578|NCT02443402|Participants were recruited from four academic hospitals including Emory University Hospital, Emory Midtown Hospital, Emory Saint Joseph's, and Grady Memorial Hospital in Atlanta, Georgia between January 2016 and October 2016.|Of the 68 participants consented for study participation, seven did not begin study participation after randomization. One participant was a screen failure prior to randomization. All participants that began a study intervention were included in the baseline analysis.
721580|NCT02443298|This was a randomized, double-blind, placebo-controlled, parallel-group multicenter study to assess the efficacy and safety of risankizumab, an IL-23p19 monoclonal antibody, compared to placebo in patients with severe persistent asthma.|All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they (the patients) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria was violated.
721581|NCT02443103|This protocol was based on enrolling 15 patients. Due to poor accrual and the decision that the approach with this agent is not feasible, the study was closed with 4 patients enrolled.|
721582|NCT02442856||
721583|NCT02442830||
721584|NCT02442804||
721585|NCT02442700||"All subjects received all 2 treatments in a randomly assigned order. The treatments were:
~Treatment A: pitavastatin; Treatment B: placebo. The sequences were Treatments AB, BA."
721586|NCT02442687||
721587|NCT02442622||
721588|NCT02442349|First patient enrolled: 22 June 2015, Data cut off: 04 March 2016. The study was open for enrollment at 31 study centres in China (24 sites), South Korea (4 sites), and Australia (3 sites). Recruitment has closed and primary analyses based on the data cut off of 04 March 2016 have been performed but study is still on-going.|319 signed informed consent from 306 patients (13 patients were re-screened). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 130 patients failed inclusion/exclusion criteria and 5 patients withdrew consent so were not eligible to be assigned treatment. Thus, 171 patients received treatment.
721589|NCT02442310||
721590|NCT02442284||
721591|NCT02442271||Treatment regimen was assigned according to HCV genotype/subtype and cirrhosis status.
721592|NCT02442206||
721593|NCT02441946||Participants who had progressive disease at the end of the study but off study drug were considered to have completed the study. Participants were randomized to anastrozole, or abemaciclib, and abemaciclib + anastrozole in cycle 1. All participants received abemaciclib + anastrozole post cycle 1.
721594|NCT02441517|Male participants from the United States were enrolled in this study.|Metastatic castration-resistant prostate cancer (mCRPC) patients who were previously treated with enzalutamide (for a minimum of 8 months), followed by docetaxel and/or cabazitaxel chemotherapy (for a minimum of 4 cycles) were enrolled in this study.
721595|NCT02441309||
721596|NCT02441283||Full Analysis Set (FAS): all participants who received ABT-493 and/or ABT-530 in a prior Phase 2/3 study and were not retreated prior to enrolling in this study.Three participants who received retreatment prior to enrollment in this study and four participants who did not receive ABT-493 and/or ABT-530 in a prior study were excluded from the FAS.
721597|NCT02441218|The target population was adult patients with stable, moderate to severe chronic heart failure (CHF) and left ventricular systolic dysfunction, with optimal and unchanged CHF medications and dosages for ≥ 4 weeks.|Following a run-in period of two weeks during which no study treatment was dispensed, the participants were randomised to receive ivabradine or placebo in addition to their usual cardiovascular treatment in double-blind treatment period.
721598|NCT02441179|"67 eligible subjects from 4 hospitals were contacted for screening on site: Hospital Mutual de seguridad, Instituto Teletón, Clínica los Coihues and Hospital del Trabajador.Only 38 accepted the invitation.
~The main reason subjects reported to not participate was a tight working schedule and/or lack of employer's permission."|Out of 38 eligible subjects, three were excluded due to brain trauma history and unknown cognitive deficits.Thus, 35 subjects were enrolled and randomly assigned to the arms.
721599|NCT02441114||
721600|NCT02441062||
721601|NCT02441036||
721602|NCT02440789|Participants were recruited at 10 Clinical Research Sites (CRSs) in the United States between December 2015 and March 2017.|
721603|NCT02440659||
721604|NCT02440633||
721605|NCT02440594|To conduct the program evaluation, clinical record data were extracted for patients (newly prescribed an antidepressant (AD), anxiolytic (AX), or antipsychotic (AP)) and caregivers enrolled in the SUSTAIN (SUpporting Seniors Receiving Treatment And INtervention) program between 8/5/10 and 5/15/14 who completed a baseline clinical interview.|
721606|NCT02440451|The participants, mainly recruited on a collaborative effort between the Pediatrics Hospital of Coimbra and local ASD associations, were invited for an fMRI neurofeedback feasibility clinical trial study in ASD. All participants had normal or corrected to normal vision. ). The first participant was recruited in February 2016.|There was no significant events after participant enrollment, before group assignment.
721607|NCT02440334||
721608|NCT02440308||
721609|NCT02440204||
721610|NCT02440022||
721611|NCT02439879|Type 2 diabetic patients with symptomatic neuropathic symptoms from 3 medical clinics in Puebla city, Mexico (one private, 2 public) were invited direct by investigator to participate if they fulfill inclusion criteria and no exclusion criteria. First patient was included on January 8th 2010 and the last visit of one patient was on December 2010|All patients meeting inclusion criteria received 600 mg of alfa-lipoic acid orally tid for 4 weeks. Patients with a TSS reduction >3 points by the end of phase 1 were selected to proceed with phase 2 of the study. Patients with a decrease <3 points in TSS or who used other neuropathic pain drugs were excluded from study phase 2.
721612|NCT02439814|Subjects were primarily recruited through media advertisements and word of mouth.|
721613|NCT02439710|Participants were recruited through NGOs utilizing their existing membership rosters, social media outlets and meetings or events.|"Participants were required to meet one of two inclusion criteria: (1) PWH (haemophilia A or B with any degree of disease severity) or (2) Controls (individuals with no bleeding disorders)"
721614|NCT02439320||Participants were randomized in a double-blind, placebo-controlled parallel group study.
721615|NCT02439281||
721616|NCT02439164||
721617|NCT02439138||
721618|NCT02438826||Study consists of a 12-week double-blind treatment phase; an optional 1-year open-label treatment phase; and a 16-week post-treatment phase (washout).
721619|NCT02438813||
721620|NCT02438787||A total of 315 participants were randomized and treated (104 participants to placebo, 106 participants to ustekinumab 45 milligram (mg), and 105 participants to 90 mg).
721624|NCT02438384|Participants were enrolled in an academic emergency department between September 2015 and March 2017 and the last participant was enrolled in March 2017. Due to unavailability of research assistants, the study was suspended during the winter of 2015 and 2017 and summer 2016.|
721625|NCT02438280||
721626|NCT02438137||
721627|NCT02437903||
721628|NCT02437890|A total of 312 subjects were randomized at 91 sites located in Europe (37 sites; 155 subjects), Asia-Pacific (19 sites, 53 subjects), North America (21 sites; 52 subjects), and Latin America (14 sites, 52 subjects). Consent was obtained from the first subject on 02 July 2015; the last subject completed the final visit on 25 January 2018.|Of the 568 subjects screened, 256 were screen failures and 312 were randomly assigned to treatment (modified Intent-to-treat [mITT] population). All subjects received study drug and were included in the safety population. Overall, 254 subjects were included in the Per Protocol (PP) population.
721629|NCT02437864||
721630|NCT02437669||
721631|NCT02437513||
721632|NCT02437487||
721633|NCT02437409|115 patients started the study, but little by little, 15 patients were excluded/discontinued due to screening failure or withdrawn consent.|No assignment to groups was performed due to single-arm study.
721634|NCT02437383||
721635|NCT02437344||
721636|NCT02437318|A total of 340 subjects were planned for the PIK3CA mutant cohort and 341 were analyzed. A total of 220 subjects were planned for the PIK3CA non-mutant cohort and 231 were analyzed.|
721637|NCT02437305|Participants were consecutive patients seen for care at Northwestern Medicine's dermatology clinic in Chicago, IL between May and July 2015.|
721638|NCT02437253||
721639|NCT02437188|Veterans indicated for orthopedic surgery and identified to be at-risk for poor outcomes were recruited following their indication clinic visit at the VAMC orthopedic clinic.|Eligible participants were randomized at their enrollment visit following phone screening. They were excluded if imminent risk of suicide. Active treatment groups received both ACT and TAU.
721640|NCT02437162||A total of 347 participants were randomized, and 346 participants were treated (116 participants to placebo, 116 participants to ustekinumab 45 mg, and 114 participants to 90 mg).
721641|NCT02436915||
721642|NCT02436889||
721643|NCT02436811||
721644|NCT02436759|Planned sample size approx 150 subjects, 100 subjects in the RVL-1201 group, and 50 in the Vehicle group, to be enrolled at approx 20 clinical sites in the US.|
721645|NCT02436681|Subjects were recruited from treating surgeon's normal practice.|3 found to be ineligible (inclusion/exclusion) at surgery 2 Withdrew consent prior to surgery 2 Mesh not implanted per surgeon discretion 2 Canceled procedure
721646|NCT02436668|This study was conducted at 75 centers in the United States (US), European Union, and South Korea. The first subject enrolled 08 May 2015 and the last was enrolled on April 19, 2018.|There was a safety run-in of 6 patients; subsequently, 430 total patients were enrolled. Eligible subjects were required to have a confirmed diagnosis of Stage IV pancreatic adenocarcinoma within 6 weeks of randomization evaluable per RECIST 1.1 criteria with at least 1 measurable metastatic lesion. Key exclusion criteria included any previous cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
721647|NCT02436577|This study was conducted at PAREXEL International, Early Phase Clinical Unit London, Middlesex, United Kingdom.|Participants were randomized to a 6 sequence Williams square design for 3 periods and 3 treatments: 90 mg ticagrelor orodispersible (OD) tablet with water (Treatment A); 90 mg ticagrelor OD tablet without water (Treatment B); 90 mg ticagrelor immediate-release (IR) tablet with water (Treatment C).
721648|NCT02436356||
721649|NCT02436330|Obese and overweight children (BMI ≥85th percentile) ages 8 through 12 years were referred to the program from their primary care practices or self-referred through advertisements distributed by the local park district and a community organization.|Participants with medical, developmental or psychiatric diagnoses which precluded participation in the curriculum or those taking medication that could significantly affect weight were excluded. Eighty-four subjects, mean age 10.1 years (SD 1.3 years), participated in the study from April 2011 through September 2013.
721650|NCT02436304|Participants were recruited from 19 study centers located in Canada (3) and the US (16).|Of the 404 enrolled, 48 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (356).
721651|NCT02436239||Patients who completed lead-in study VLZ-MD-22 (NCT02372799) had already completed a down-taper period at the end of study VLZ-MD-22 and were not required to undergo a washout period in VLZ-MD-23. For de novo patients, the screening/washout period was generally 1 week prior to Baseline.
721652|NCT02436200||
721653|NCT02436135|Participants were enrolled at study sites in the United States. The first participant was screened on 05 June 2015. The last study visit occurred on 20 November 2017.|12 participants were screened. Participants were enrolled in Cohorts A and B. After the fourth participant in Cohort B was enrolled, the study was terminated. No additional participants were enrolled.
721654|NCT02436031||
721655|NCT02436005||
721656|NCT02435966|Recruitment took place between May 2013 and June 2014 at Physios, a private physiotherapy practice in central Madrid (Spain)|No significant event here
721657|NCT02435914||
721658|NCT02435901||There were no significant events in the study which prevented participant enrollment.
721659|NCT02435836|This trial was conducted in 631 participants at 139 trial sites in 23 countries.|All participants enrolled in this trial had previously participated in the double-blind aripiprazole; 89 participants from trial 31-97-301 and 542 participants from trial 31-98-304-01. NCT numbers were not available for these 2 trials as this was before the requirement. Studies were initiated in 1997 (31-97-201) and 1998 (31-98-304-01).
721660|NCT02435706||
721661|NCT02435524||Rural communes were randomised in this study. There are 47 communes in Boucle du Mouhoun; 6 urban communes were excluded leaving 41 rural communes to be randomised to either the intervention or control arm. Of these, 2 intervention and 2 control communes were excluded due to co-intervention.
721662|NCT02435511||No participants were excluded after enrollment, prior to randomization.
721737|NCT02428309|Participant recruitment occurred at one site in the United States. The site was activated in August 2015.|
721738|NCT02428296||
721663|NCT02435433||Completers include participants who had died due to any cause or alive and on study at the end of study, but off treatment. Results for open label and maximum extended enrollment participants will be posted after the study completion.
721664|NCT02435277|Study NS-0100-01E was a randomized, double-blind 8-week extension of Study NS-0100-01 to evaluate the effect of various fixed-dose combinations of leucine and metformin compared to standard metformin monotherapy on glycemic control.|Subjects meeting all inclusion criteria and no exclusion criteria for the NS-001-01-E, including completion of the 4-week treatment period of Study NS-0100-01 (Day 28/Visit 7), were eligible to enroll into the NS-001-01-E.
721665|NCT02435147|This is a single-site, non-randomized observational study of post-menopusal women between the ages of 40 and 90 years who completed a minimum of 36 months of denosumab therapy for the treatment of osteoporosis and had evaluable DXA scans. Women were recruited to participate from a single clinical practice site between March 2015 and March 2016.|
721666|NCT02435069|Participants recruited from subspecialty clinics at Nemours Children's Clinic in Jacksonville, Florida between February 2016 and January of 2017|9 assessed for eligibility, 4 excluded (3 did not meet inclusion criteria and 1 surgery date significantly delayed), 5 consented and randomized to treatment sequence in dosing phase (3 started on saline followed by USP Glycerin, 2 started on USP glycerin followed by saline).
721667|NCT02434939|This study enrolled children with SCD aged 7-18 with severe acute VOC admitted to the Sickle cell day care center at Mulago National Refferal Hospital from June 2015 to February 2016|Of the 800 patients, 314 met the inclusion criteria with a further 74 excluded. these included 28 with history stroke, 17 with SPO2 < 90, 14 declined, 2 had altered mentation and 13 had undisclosed reasons. only 240 patients were randomized.
721668|NCT02434770|Subjects were recruited from the communities in the vicinity of the study clinics (KEMRI/Walter Reed Project Kombewa Clinical Research Center and Obama Children's Hospital in Kisumu and at the Kenya Medical Research Institute/Walter Reed Project in Kericho, Kenya).|"Infants were enrolled prior to receipt of the birth dose of bivalent oral poliomyelitis vaccine (bOPV} and were were allocated to 1 of 3 arms:
~Beijing Bio-Institute Biological Products Co., Ltd. (BBIBP) liquid bOPV Lot 1;
~BBIBP liquid bOPV Lot 2; and
~World Health Organization (WHO) prequalified comparator bOPV (BioFarma)."
721669|NCT02434523||
721670|NCT02434497|The nine (9) patients recruited were all participants in the D3561C00004 HYDRA study (NCT02226198) four came from Sequence A and five from Sequence B|
721671|NCT02434471||Subjects did not continue participation in the study if their scans were cancelled or rescheduled outside of their hospitalization. Twenty enrolled subjects fell into this category.
721672|NCT02434328|Subjects were recruited from investigative sites located in Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, South Korea, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey, UK, and Vietnam.|Of the 1048 subjects enrolled in the study, 305 were exited prior to randomization as screen failures. This reporting group includes all randomized subjects.
721673|NCT02434146|This study enrolled adult participants undergoing hematopoietic stem cell transplantation (SCT) who were to receive cyclophosphamide and TBI as the conditioning regimen. Participants were recruited from the University of Wisconsin Hospitals and Clinics between May 2015 and December 2015.|
721674|NCT02433834|Randomized, Double-Blind, Chronic-Dosing (14 days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center, Dose-Ranging Study to Assess the Efficacy and Safety of PT001 Relative to Placebo MDI and Open-Label Serevent® Diskus® Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma|Eligible subjects were randomized to 1 of 24 pre-defined treatment sequences. There were 5 treatment periods lasting 14 days with a 7-14 day washout period in between and a follow-up phone call 7-14 days post final dose. By-sequence tabulations of the data were not pre-specified.
721675|NCT02433678||
721676|NCT02433665||A total of 10 enrolled subjects either screen failed or were withdrawn by the PI prior to randomization. Four subjects screen failed due to changes in their clinical orders prior to imaging. Six subjects were withdrawn by the PI due to patient scheduling conflicts.
721677|NCT02433613||
721678|NCT02433496||Clinics were paired and randomly assigned to be grouped in the intervention or control group. The intervention group was invited. If clinics in this group refused to participate, the other clinic of the pair was invited to be a part of the intervention group. Once clinics agreed to take part in the study they were immediately assigned to a group.
721679|NCT02433483|Two participants and 2 bone marrow or blood stem cell donors were enrolled at St. Jude Children's Research Hospital between May 2015 and July 2015. The donors do not undergo protocol therapy interventions and are not included in the results reporting provided here.|
721680|NCT02433366|"This is a cross-sectional survey. Pradaxa® prescribing healthcare professionals and Pradaxa® treated patients were randomly selected and interviewed (face-to-face).
~411 healthcare professionals and 802 patients with atrial fibrillation were enrolled and entered the study"|
721681|NCT02433340|A total of 158 participants (98% of those eligible) diagnosed with active rheumatoid arthritis (RA) on background methotrexate who had participated in the randomized controlled trial M12-963 (NCT02141997) enrolled in this open-label extension. Results include analyses of data for these participants from time points during M12-963, per protocol.|
721682|NCT02433288|885 patients signed Inform Consent and were randomized in the study, 443 subjects in the active group and 442 subjects in the control group. 320 (72.2%) and 316 (71.5%) patients, respectively, completed the study. The overall completion rate was 71.9%. 31 patients (12 and 19 respectively) was not successful in receiving the relevant application.|A total of 885 patients were randomized (1:1) to two groups: an active group which received the smart phone-based patient support tool and a control application used for data collection only.
721683|NCT02433080||Although 60 participants were enrolled, only 54 were included in the study analysis as the remaining 6 participants were deemed ineligible to participate and excluded from the analysis.
721684|NCT02432742||
721685|NCT02432729||
721686|NCT02432716||
721732|NCT02428699|Participants were recruited at one Centre in United Kingdom.|A total of 93 participants were screened, out of which 50 participants were randomized. 39 participants failed screening and 2 participants withdrew from the study. 2 participants discontinued due to other reasons (reason not specified).
721733|NCT02428608||
721687|NCT02432456|"Adult Study: From August 2015 to December of 2017, all adult blunt trauma patients with three or more rib fractures were screened for eligibility in this study.
~Elderly Study: From August 2015 to June 2018, all elderly blunt trauma patients with three or more rib fractures were screened for eligibility in the study."|153 patients agreed to participate. Three subjects (two from elderly and one from adult) were randomized but withdrawn prior to collecting any data or initiation of the infusions. This left a total of 150 participants within the trial, of which 75 were randomized to the placebo infusion with the other 75 randomized to the ketamine infusion.
721688|NCT02432300||Participants were only enrolled in the treatment if they were found to have met the criteria for moderate to severe alexithymia on the Toronto Alexithymia Scale 20 (>=52).
721689|NCT02432287||
721690|NCT02432274|Participants took part at 19 investigative sites in France, Germany, Italy, Spain, United Kingdom and the United States. Total 117 participants were enrolled and screened, of which 20 participants were screen failures and 97 participants received study treatment.|Prior to entering Cohort 1, participants aged 2 to less than (<) 6 years underwent a run-in period and received lenvatinib 5 milligram per square meter (mg/m^2) per body surface area (BSA) as capsules or suspension once daily for 21 days. In this result summary, data has been reported at primary completion date (18 July 2019) of the overall study.
721691|NCT02432196||
721692|NCT02432144|Participants with mucopolysaccharidosis VII (MPS 7) who were UX003 treatment-naïve or previously enrolled and treated in a prior clinical study of UX003 could enroll into this treatment and extension study provided all eligibility criteria had been met for a given participant.|Ten of 12 participants entered this extension study at study Week 0 with ongoing UX003 treatment for the prior 24 or 48 weeks in study UX003-CL301 [NCT02230566]; 2 participants had a large gap between studies (61 weeks between doses).
721693|NCT02432105|Participants were recruited from 18 study centers located in the US and 2 study centers located in Canada.|Of the 470 enrolled, 85 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (385).
721694|NCT02432040|The study was conducted from February 2013 to October 2013 at a dermatology out-patient clinic in a tertiary hospital in the Philippines. Patients diagnosed with mild to moderate chronic plaque type psoriasis were screened for eligibility.|Patients who were not newly diagnosed with psoriasis and already on medications were allowed to be enrolled into the study as long as they have been free of any systemic anti-psoriatic therapy for at least 2 months or free from topical steroids for at least 2 weeks.
721695|NCT02431806||
721696|NCT02431793||
721697|NCT02431754||
721698|NCT02431741||
721699|NCT02431676||
721700|NCT02431650||
721701|NCT02431637||
721702|NCT02431598||
721703|NCT02431572||
721704|NCT02431559||
721705|NCT02431533||
721706|NCT02431494||The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
721707|NCT02431468|Planned: 250 subjects to be screened for a total of 140 subjects randomized 1:1:1 to one of three treatment arms: 20μg, 40μg or placebo Actual: 264 subjects were screened. 147 individual subjects were randomized and of those, 141 were dosed with trial drug.|
721708|NCT02431455||
721709|NCT02431299||
721710|NCT02431273||
721711|NCT02431260||
721712|NCT02431247||Results are reported through Week 48 (primary analysis). Complete data through final analysis (through Week 96 and follow-up) will be reported within 1 year of end of trial date when final data based on study completion date will be available.
721713|NCT02431052||
721714|NCT02430870|Participants took part in the study at 2 investigative sites in the United States from 02 April 2015 to 04 November 2015.|Participants with a diagnosis of Type 2 Diabetes Mellitus (T2DM) were enrolled in 1 of 3 treatment groups: placebo, 0.35 mg or 0.80 mg TAK-648 in Part 1. Healthy Japanese volunteers were enrolled in 1 of 5 treatment groups: placebo, 0.05 mg, 0.15 mg, 0.35 mg or 0.80 mg TAK-648 in Part 2.
721715|NCT02430818||
721716|NCT02430532||
721717|NCT02430480||
721718|NCT02430389|Northwestern Memorial Hospital Ambulatory Surgery Unit or equivalent location where preoperative anesthesia evaluation occurring.|
721719|NCT02430337||
721720|NCT02430311|This study was performed at 3 study centres in China.The first patient entered the study on 10 June 2015 and the last patient completed Part A of the study on 02 August 2016, and the date of last patient last visit in Part B was 28 April 2017.|47 patients were screened in the study. 11 patients were not assigned to treatment due to eligibility criteria not fulfilled. 5 patients excluded from the PK analysis set due to previous gastric surgery. 1 of the 5 patients was also excluded due to vomiting within 3 hours of dosing on a PK day or on the 3 days prior to a multiple dose PK Day.
721721|NCT02430090||
721722|NCT02429869|Ten HIV-infected adult solid organ transplant participants on stable ART and were taking non-mTOR based immune suppressive regimens for allograft rejection were recruited at the University of California, San Francisco in this open label, single-arm everolimus trial.|
721723|NCT02429856||
721724|NCT02429791|This study was a 148-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study to assess the antiviral activity and safety of a two-drug regimen of dolutegravir (DTG) + rilpivirine (RPV) compared with current antiretroviral regimen (CAR). The study was conducted at 65 centers in 13 countries.|Total 641 participants were screened (131 failed), 510 participants were randomized and 2 participants withdrew before being exposed to study drug. The study included a Screening phase, an early switch phase, a late switch phase, and a continuation phase. The results presented are based on the interim analysis of the Late Switch Phase (Week 148).
721725|NCT02429778||
721726|NCT02429583||
721727|NCT02429427||
721728|NCT02429310||
721729|NCT02429258||226 subjects signed the informed consent form (ICF), and 132 subjects were screened to randomize a total of 100 subjects.
721730|NCT02429115||
721731|NCT02428855||
721734|NCT02428595||
721735|NCT02428478||
721739|NCT02428231||
721742|NCT02427958|Participants took part in the study at 11 investigative sites in China from 07 August 2015 to 23 November 2018.|Chinese participants with central precocious puberty (CPP) were enrolled to receive leuprorelin as per body weight.
721743|NCT02427750|Participants were enrolled from one study center in Brazil.|All enrolled subjects were included in the trial.
721744|NCT02427737|At OSUMC randomization was maintained (3 trained, 3 control sites). At Duke University considerable staff cuts at the onset of the trial resulted in extensive staff rotations making maintenance of randomization impossible. Thus a pre-post training comparison for the 6 sites was done (pre-training baseline = control, post-training = training arm)|"Different participants were assessed at baseline and at each period after training.
~Clinical sites, not participants, were enrolled in the study. Note that participants refers to all patients scheduled to be examined on the available imaging slots, including patients who showed (completed) and those who were no-shows (not completed)."
721745|NCT02427672||
721746|NCT02427646||Protocol enrollment identifies participants who agreed to participate and sign the consent form (total N=54). However, in the total started participant flow, two participants did not have a high enough tremor severity or consistent tremor severity during the scripted tasks held during the kinematic technology assessment, leaving N=52 in the study
721747|NCT02427607||This study was conducted at 8 centers in Japan during the period of 12 May 2015 to 21 Sep 2016. E2007-J000-341 is an open-label extension of E2007-G000-332.
721748|NCT02427477||A total of 120 subjects were enrolled into this study. All enrolled subjects were dispensed a study lens. Of the dispensed subjects 1 was discontinued from the study and 119 subjects completed the study.
721749|NCT02427399||
721750|NCT02427100||
721751|NCT02426918|Participants took part in the study in the United States, from 14 May 2015 to 12 September 2016. Of the 505 participants screened, 175 discontinued from the study prior to randomization and 330 were randomized.|Participants with acute bacterial skin and skin structure infections (ABSSSI) due to Staphylococcus sensitive or resistant to Methicillin were randomized to one of the three treatment arms in a 1:1:1 ratio.
721752|NCT02426749||
721753|NCT02426658||
721754|NCT02426580|"Patients were retrospectively from January 2014 to January 2015 and prospectively enrolled from Apr. 2015 to Apr. 2017 in the control group.
~Patients were prospectively enrolled in intervention with wechat group from Apr. 2015 to Apr. 2017."|
721755|NCT02426541|A total of 55 subjects were enrolled and 32 subjects were randomised and treated. One participant was withdrawn prior to study completion. Thirty-one participants completed the study and attended all visits.|
721756|NCT02426138||
721757|NCT02426125||Completers include participants who had died due to any cause or alive and on study at the end of study, but off treatment.
721758|NCT02425956||
721759|NCT02425826|Participants enrolled into this study were those with moderate plaque psoriasis without prior treatment with systemic agents or biologics and were enrolled across 25 study centers in the United States.|Participants were randomized in a 2 to 1 ratio to receive apremilast or placebo.
721760|NCT02425449||
721761|NCT02425111|Participants took part in the study at 42 investigative sites in Belgium, Canada, Czech Republic, France, Hungary, Italy, Poland and the United States from 30 March 2015 to 21 February 2018.|Participants with a diagnosis of Crohn's Disease were enrolled and received vedolizumab.
721762|NCT02425098|Participants took part in the study at 3 investigative sites into Singapore from 03 June 2015 to 18 September 2017.|Healthy volunteers were enrolled and randomized in 1:1 ratio to receive single injection of either high-dose tetravalent dengue vaccine (HD-TDV) or tetravalent dengue vaccine (TDV).
721763|NCT02424799|This study was conducted from 17-November-2014 to 10-November-2017 at centers two centers in the United Kingdom and two centers in Germany.|92 participants were screened (3 re-screened) of which 58 were screen failures. Hence 34 participants, 17 healthy participants (Part A), 12 participants with cold urticaria (CU, Part B) and 5 participants with chronic spontaneous urticaria (CsU, Part C) were randomized.
721764|NCT02424734||
721765|NCT02424630|Rotator cuff tears were diagnosed by preoperative MRI, and the size of the rotator cuff was confirmed at the time of surgery. The indication for surgery was a symptomatic full thickness rotator cuff tear or a > 50% thickness partial thickness rotator cuff tear. From Aug 2013 to Jul 2014, the recruitment was done at Orthopeic department.|Assessed for eligibility (n= 54) Excluded (n= 2) previous fracture history of affected shoulder (n= 1) previous cerebral palsy history involving affected shoulder(n= 1) preassignment(n=52)
721766|NCT02424591|Patients were approached either at pre-admission testing or at the peri-op area of the hospital. All patients were spoken to privately and given time to ask questions. After consent was signed, a copy was given to the subject and a copy put into the medical record.|One patient was excluded because his surgery was cancelled.
721767|NCT02424578||
721768|NCT02424565|Participants were recruited at one center in India.|Of the 19 participants screened, 15 were randomized, 14 completed the study.
721769|NCT02424539|This efficacy and safety study of fluticasone furoate (FF) was conducted at 16 centers in China. A total of 505 pediatric participants with allergic rhinitis were screened; of which 147 were screen and run-in failures and 358 were randomized in a 1:1:1 ratio to receive placebo, FF 55 micrograms (µg) or FF 110 µg once daily (QD).|
721770|NCT02424526||
721771|NCT02424383|Overall, 1005 subjects were enrolled and treated with the study device. A total of 966 subjects were included in the Per-Protocol population (excludes subjects with major protocol deviations) for final analysis.|Between 2015 and 2017, Investigators treated 1005 subjects with the study device. Due to major protocol deviations, 39 subjects were excluded from the analyses conducted in this study. Therefore, the Per-Protocol population included 966 subjects and all outcome results and baseline data are based on this Per-Protocol population.
721772|NCT02424357||
721773|NCT02424344|This study was conducted at 26 study centers, 15 in Germany, 4 in Hungary, 3 in Spain and 4 in Canada. The first patient was enrolled in April 2015 and the last patient visit was in July 2016.|335 patients were screened; 267 were assessed as eligible and were randomized into the study. 68 patients failed screening. The main reason for screening failure was non-fulfilment of inclusion or exclusion criteria (16.7%).
727603|NCT01961323|Recruitment took place at Icahn School of Medicine at Mount Sinai outpatient cardiology clinic from Dec 11, 2014 to Dec 2, 2016.|
721774|NCT02424175|Recruitment for this study lasted from February 2016 until June 2017. 10 total patients were recruited through the Brigham and Women's Hospital Gastroenterology clinic and through referrals from other Gastroenterologists.|A wash out period was included for patients. All subjects should not have used antibiotics within 2 months of start date or receive treatment of infliximab, adalimumab, certolizumab, natalizumab, vedolizumab or thalidomide within the past 8 weeks. They are also screened for various infectious risks such as HIV or Hepatitis.
721775|NCT02424149||
721776|NCT02424097||
721777|NCT02423993||
721778|NCT02423980|A total of 7 adults with type 1 diabetes were recruited at a clinical research center over a period of 1 month.|One subject was given the 1 mg dose of glucagon at both treatment visits, so only 6 subjects received the 0.5 mg dose.
721779|NCT02423798|All Subjects|All Subjects
721780|NCT02423577||Potential subjects were screened to determine their susceptibility to infection with the challenge strain as indicated by a serum antibody titre less than 1:10. Only subjects susceptible to the challenge strain qualified for study specific screening.
721781|NCT02423447||
721782|NCT02423408||
721783|NCT02423317||
721784|NCT02423291||
721785|NCT02423200||During the course of the study, and after one subject had been enrolled in the 125 mg dose group, FDA mandated the removal of the 125 mg dose group. As a result, the number subjects was revised downward to 9, 8 as planned in the 40 mg dose group and 1 in the 125 mg dose group.
721786|NCT02423122||
721787|NCT02423109||44 subjects were enrolled (assigned an ID per protocol), but 11 were not assigned to any group due to screen failure.
721788|NCT02422940||
721789|NCT02422797|This study was a 148-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study to assess the antiviral activity and safety of a two-drug regimen of dolutegravir (DTG) + rilpivirine (RPV) compared with current antiretroviral regimen (CAR). The study was conducted at 60 centers in 11 countries.|Total 639 participants were screened (121 failed), 518 participants were randomized and 2 participants withdrew before being exposed to study drug. The study included a Screening phase, an early switch phase, a late switch phase, and a continuation phase. The results presented are based on the interim analysis of the Late Switch Phase (Week 148).
721790|NCT02422615|A total of 660 patients were planned and 726 patients were randomized in a ratio of 2:1 with 484 patients in the ribociclib plus fulvestrant arm and 242 patients in the placebo plus fulvestrant arm.|
721791|NCT02422446||
721792|NCT02422303||
721793|NCT02422290||
721794|NCT02422264||
721795|NCT02422186||Total 139 participants were enrolled, out of which 138 were randomized and 1 participant was excluded due to Good Clinical Practice (GCP) non-compliance.
721796|NCT02421952||
721797|NCT02421939|Participants were recruited from approximately 140 centers in North America, Europe, Asia and the rest of the world and randomized in a 2:1 ratio to receive gilteritinib or salvage chemotherapy. Participants had FMS-like tyrosine kinase 3 (FLT3) mutations and relapsed or refractory acute myeloid leukemia (AML) after first-line therapy.|Participants entered the screening period up to 14 days prior to the start of treatment. Prior to randomization, the investigator preselected a salvage chemotherapy for each participant. The randomization was stratified by response to first-line AML therapy and preselected salvage chemotherapy. Treatment was given over continuous 28-day cycles.
721798|NCT02421887||
721799|NCT02421666||
721800|NCT02421588|First randomization/first study treatment administration took place on 26JUN2015. The cutoff date for results was 12OCT2018. 534 patients were screened; 442 were randomized at 83 sites/12 countries. 10 patients did not receive the study treatment.|IC;Age≥18 years;confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer;Platinum-resistant disease;ECOG PS≤2;Adequate hematological, renal, metabolic, and hepatic function
721801|NCT02421510|Participants took part in the study at 96 investigative sites throughout 17 countries from 21 May 2015 to 23 June 2017.|995 participants were screened and 782 participants with a diagnosis of Type 1 diabetes mellitus were randomized equally in 1 of 3 treatment groups: sotagliflozin 400 mg, sotagliflozin 200 mg or placebo.
721802|NCT02421419||
721803|NCT02421354|Recruitment Period: May 2015 to October 2017|
721804|NCT02421224||
721805|NCT02421211||A total of 41 participants were enrolled in the study, among them 40 participants (20 per panel) were randomized and treated. One participant was early terminated from the study, due to withdrawal of consent before randomization to study drug. All randomized participants received study drug and were included in the intent to treat (ITT) population.
721806|NCT02421172|Study with 4 wks screening,two sequential treatment periods 16 wks (Period 1 & Extension Period 2)& 12 wks Follow-up. Randomization 2:1:1 to three sequences:Seq. 1: Period 1: CJM112 High Dose sc then Period 2: placebo sc; Seq. 2: Period 1: Placebo sc then Period 2: CJM112 Low Dose sc; Seq, 3: Period 1: Placebo sc then Period 2: CJM112 High Dose sc|A total of 66 patients were enrolled, randomized and entered into two sequential periods (Period 1 and Extension Period 2) of which 60 patients completed Week 16 in Period 1 and entered Extension Period 2.
721807|NCT02421146||
721808|NCT02421120||
721809|NCT02421094||
721810|NCT02421055||Some participants consented to give serum samples only, others were able to give complete sets of serum, 24-hour urine and stool, as detailed below.
721811|NCT02420951||
721812|NCT02420873|May 2015 through July 2016. All of the participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.|All of the participants registered on this study have CD56 expressing hematological malignancies and were assigned to cohort 1 of this study. No participants registered on this study had a diagnosis of Myelofibrosis or Blastic Plasmacytoid Dendritic Cell Neoplasms, Therefore, zero participants were analyzed on cohort 2 or cohort 3 of this study.
721813|NCT02420821||A total of 1228 participants were screened, out of which, 915 participants were enrolled into the study.
721814|NCT02420691|September 2015-August 2016. All patients enrolled at MD Anderson.|21 participants consented, 1 participant was not eligible due to screen failure.
721815|NCT02420379|The study was conducted at 13 sites in the United States.|A total of 33 participants were enrolled in the study treatment.
721818|NCT02420262|The trial was conducted at 89 sites in 12 countries: Argentina (3 sites), Czech Republic (5 sites), France (3 sites), Greece (6 sites), Hungary (3 sites), Israel (6 sites), Mexico (3 sites), Russia (7 sites), Slovakia (5 sites), Spain (6 sites), Turkey (5 sites) and United States (37 sites).|Subjects with type 2 diabetes mellitus were on treatment with stable daily dose of insulin glargine (IGlar) between 20 units and 50 units (both inclusive) for at least 56 days prior to screening in combination with a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) for at least 90 days prior to screening.
721819|NCT02420210||
721820|NCT02420093||
721821|NCT02420041||
721822|NCT02420015||One participant was deemed ineligible to participate in the study prior to randomization because that participant couldn't read or write English.
721823|NCT02419937||
721824|NCT02419924||
721825|NCT02419807||
721826|NCT02419755|Twelve participants were enrolled at St. Jude Children's Research Hospital between April 2015 and October 2016.|
721827|NCT02419690||
721828|NCT02419612|A total of 444 subjects were randomized in this international, multi-center study which was conducted at 88 centers in 10 countries between 14 Aug 2015 and 18 September 2019.|The study duration was up to 160 weeks, consisting of a 2-week screening period, 2-week lead-in period, 52-week short-term treatment period, and 104-week long-term treatment period (156-week treatment period). One subject did not start the short-term treatment period and so only 443 subjects received treatment.
721829|NCT02419573||
721830|NCT02419547|Subjects undergoing VT ablation were enrolled over 1 year period|
721831|NCT02419521||
721832|NCT02419508|This study was conducted at 37 sites located in Argentina (3), Australia (4), Canada (12), Chile (3), France (1), Germany (3), Greece (2), Israel (3), Spain (3), and United Kingdom (3).|Of the 290 subjects enrolled in the study, 102 were exited during the Screening/Eligibility period. This reporting group includes all randomized subjects. One randomized subject did not receive investigational product and is excluded from the Full Analysis Set and the Safety Analysis Set.
721833|NCT02419469||
721834|NCT02419313||
721835|NCT02419001||
721836|NCT02418910||
721837|NCT02418819||A total of 103 participants were randomized and assigned to study treatment. One (1) participant in the PF-06412562 3 mg twice a day (BID) group and 2 participants in the PF-06412562 45 mg BID group did not receive study drug. Therefore, 100 participants received study treatment.
721838|NCT02418754|The study was conducted at 82 sites in US and 11 sites in Japan. A total of 804 participants were screened. Out of 804 participants, 505 were randomized and treated.|Participants were initially randomized in a 1:2:2 ratio to receive REGN2176-3 (1 mg:2 mg) (REGN2176 1 mg:REGN3 2 mg) or REGN2176-3 (3 mg:2 mg) (REGN2176 3 mg:REGN3 2 mg) or 2 mg intravitreal aflibercept injection (IAI). One eye was under study (the fellow eye was assessed for safety only).
721839|NCT02418676|A randomized, double-blind, prospective clinical trial was conducted from March 2013 to April 2014 at the Hospital Universitário Regional de Maringá (HUM), Paraná, Brazil, in order to determine the safety and efficacy of gel in patients hospitalized in the Intensive Care Unit.|The volunteers were Brazilian, bedridden, both genders, between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study. Grade II pressure ulcers were selected as they are a superficial lesion, with little tissue loss, and allow easy visualization of healing.
721840|NCT02418585||Total 236 participants were enrolled, out of which 227 were randomized and 9 participants were excluded due to Good Clinical Practice (GCP) violations.
721841|NCT02418546||
721842|NCT02418468||
721843|NCT02418455||
721844|NCT02418312||
721845|NCT02418234||
721846|NCT02418182||
721847|NCT02418156||
721848|NCT02418026||
721849|NCT02418000||
721850|NCT02417961||162 participants signed informed consent, 116 participants receive treatment with benralizumab 30 mg at every 4 weeks schedule.
721851|NCT02417935|12 week Treatment period, followed by 1 week Tapering period, followed by 1 week follow-up period.|
721852|NCT02417844||Each treatment was administered after consumption of a high-fat, high-calorie breakfast.
721853|NCT02417831||
721854|NCT02417753||
721855|NCT02417532||
721856|NCT02417441||A total of 976 subjects were enrolled, out of which 970 subjects were randomized and started the study.
721857|NCT02417376|Total 100 CHD patients recruited from Cardiology department of MY hospital, Indore, were evaluated at department of Periodontology, GDC Indore, for final selection.|
721858|NCT02417246||61 participants were consented with 10 participants as screen fails, 2 declining to further participate, and 1 unable to fit standard monitoring equipment.
721859|NCT02417233||
721860|NCT02417129|It was planned to randomize approximately 250 patients (125 in each treatment group). Actually two patients were randomized, an additional patient was enrolled but not randomized. Two patients were randomised to BI 695500, thus no patient was treated with rituximab in this trial.|"All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that the subject met all strictly implemented inclusion/exclusion criteria.
~Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated."
721861|NCT02417064||
721862|NCT02416973||
721863|NCT02416934|Potential participants undergoing elective anterior cervical spine surgery will be seen by spine surgeons at the WVU Spine Center. Participants will be told about the study and given the opportunity to consent. Consented participants will be randomized to either the steroid administration group or the saline administration group.|
721864|NCT02416908|The study was opened to allow participant enrollment on 06/16/2015 and the study was closed to participant enrollment on 01/22/2018.|"Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data
~Maintenance Phase patients are patients who were enrolled & treated in Phase I Schedule A or Phase II but met certain criteria to receive maintenance selinexor. Their data will only be included in adverse event results."
721865|NCT02416791||
721866|NCT02416713||
721867|NCT02416622|No participants have completed the study at this time because the study is ongoing (overall status: active, not recruiting). All enrolled participants are in long term follow-up.|
721868|NCT02416193|Recruitment for this study took place at Loyola University Medical Center (Maywood, IL) between September 2015 and June 2018|Fifty-six participants consented to participate in the study. Among these individuals, 26 (46.43%) were not randomized and were excluded from continuing their participation in the study because the medical monitor determined they did not meet study inclusion criteria.
721869|NCT02416180||Participants with controlled asthma who were treated with fluticasone propionate/salmeterol via DISKUS inhaler, were asked to demonstrate how they currently use their DISKUS inhaler using a demonstration inhaler. Only participants who did not make any critical errors while demonstrating the inhaler technique were considered eligible for the study.
721870|NCT02416102||
721871|NCT02416011||
721872|NCT02415998||
721873|NCT02415959||
721874|NCT02415855|Participants were approached after the treating physician's decision to treat with dabigatran within 14 days of stroke/TIA, independent of the registry.|
721875|NCT02415842|Subjects analyzed in this study were subjects enrolled and analyzed in the According-to-Protocol (ATP)cohort for immunogenicity from Hemagglutinin (HA) Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines).|The HA Group 1-related studies were the followings: (FLU Q-PAN H1N1-019; [113536]; FLU CC-PAN H5N1-001[114371]; FLU Q-PAN H9N2-001[116358]; FLU Q-PAN-005[110624]; H5N1-012[107495]; FLU D-QIV-015[201251] and FLU Q-PAN H5N1-AS03-021[114464]).
721876|NCT02415608||
721877|NCT02415595|This study was originally designed for 96 weeks of treatment in treatment naïve human immunodeficiency virus-1 (HIV-1) infected adults; however, it was terminated early due to gastrointestinal intolerability and treatment emergent resistance. The study was conducted at 58 centers in 12 countries.|A total of 305 participants were screened, of which 210 were randomized to 1 of 4 treatment arms. Of 210 participants, only 206 received study treatment. Four participants were randomized but not treated as: 2 participants were randomized in error, 1 participant was lost to follow-up and 1 participant withdrew consent.
721878|NCT02415439|In the single ascending dose (SAD) study, subjects were assigned to 1 of 7 dose groups and received a single oral dose of VBP15 or placebo. The multiple ascending dose (MAD) was initiated after a review of safety data from SAD groups. In the MAD study, subjects were randomized to 1 of 4 groups to receive VBP15 or placebo once daily for 14 days|An escalating-dose design was chosen for the SAD and MAD studies to allow increase of the dose after assessment of safety and tolerability of each preceding dose. Escalation to the next higher dose was performed using a factor of 3 for each subsequent dose until a maximum of 20 mg/kg was reached. No subject received more than 1 dose level of VBP15.
721879|NCT02415400||4683 participants enrolled, 4614 randomized. Reasons not randomized: 2 adverse event; 1 request to stop therapy; 12 withdrew consent; 1 lost to follow-up; 1 poor/non-compliance; 35 no longer met criteria; 2 admin reasons by Sponsor; 10 lack of IP at site; 1 IWRS down; 2 physician recommended; 1 leaving the country; 1 pharmacogenetic sample positive
721880|NCT02415244||
721881|NCT02415166|The study was terminated after the recruitment of six participants|
721882|NCT02415127||
721883|NCT02414958|Randomised, double-blind, placebo-controlled, parallel group, 52-week trial comparing 2 oral once daily doses (10 mg and 25 mg) of empagliflozin with placebo in patients with type 1 diabetes mellitus (T1DM), each as adjunctive to optimised insulin therapy.|6-week T1DM therapy (insulin) optimisation period followed by a 2-week placebo run-in period before randomisation. Patients who successfully completed both of the periods were randomised into the 52-week double-blind treatment period. All treatments were administered in addition to optimised insulin therapy.
721884|NCT02414854|4148 participants were screened from Apr 2015-Sep 2016. 1902 were randomized at 321 centers/22 countries. 2246 were screen failures. 1897 participants were treated; some received a different treatment than that assigned at randomization and for adverse event (AE) analysis were allocated to treatment actually received (see footnotes in below table)|Randomization was stratified by age (<18 years, >=18 years), blood eosinophil count(<0.3 Giga/L, >=0.3 Giga/L), ICS dose level (medium, high), and country. Assignment to arms was done centrally using Interactive Voice/Web Response System in 2:2:1:1 ratio to Dupilumab 200 mg q2w, Dupilumab 300 mg q2w, Placebo (for 200 mg)q2w, Placebo (for 300 mg)q2w
721885|NCT02414841|696 patients signed informed consent; 613 patients were randomized; 603 were treated|Participants were excluded if they did not have a radiocephalic fistula created at the time of surgery
721886|NCT02414828||
721887|NCT02414698||
721888|NCT02414633||
721889|NCT02414243||
721890|NCT02414204||
721891|NCT02414152||
721892|NCT02413996|Participants were recruited at the Rehabilitation Department, IRCCS Orthopedic Institute Galeazzi, Milan, between September 2014 and November 2017.|
721893|NCT02413918|Recruitment occurred April 2013 to April 2015 from patients in the clinic or from responders to t.v. advertisements.|Subjects who met inclusion criteria at screening visit were started on study medication at visit 2.
721894|NCT02413879||"There were 11 subjects in an initial study phase conducted at a single-center. The protocol was modified following this phase. Also, 11 subjects were in a pre-specified roll-in phase. The 22 participants in the Initial Study Phase and Roll-In Phase account for the discrepancy between Protocol Enrollment and Participant Flow Started value."
721895|NCT02413684||
721896|NCT02413593|Participants were enrolled at study sites in Canada. The first participant was screened on 15 April 2015. The last study visit occurred on 08 January 2016.|127 participants were screened.
721897|NCT02413580||
721898|NCT02413489||In total 36 participants were treated (15 participants in the diffuse large B-cell lymphoma [DLBCL] cohort, 16 participants in the follicular lymphoma [FL] cohort, and 5 participants in the mantle cell lymphoma [MCL] cohort).
721899|NCT02413463|Children with partially accommodative esotropia were recruited from the strabismus clinic of Pediatric Hospital of Cairo University during the period from January 2015 through December 2016. All patients' guardians received a thorough explanation of the study design and aims, and signed a written informed consent.|
721900|NCT02413398||
727604|NCT01961297|75 subjects were consented, some did not meet criteria, and 53 were enrolled into the study.|
721901|NCT02413372||184 participants enrolled; 80 entered lead-in phase; 75 were randomized and treated. Those did not enter lead-in phase: 95 no longer met study criteria; 5 withdrew consent; 1 poor/non-compliance; 3 other reasons. 2 from lead-in phase not randomized as no longer met study criteria. 3 from lead-in phase were randomized in the PK cohort (sub-study).
721902|NCT02413346|Long-term safety study for participants who were treated for moderate to severe facial acne vulgaris in the double-blind studies SC1401 [NCT02320149] or SC1402 [NCT02322866].|
721903|NCT02413333|Participants were recruited from ten investigational centers located in the United States.|All randomized participants (132). One enrolled participant discontinued prior to randomization.
721904|NCT02413294||
721905|NCT02413255|Participants took part in the study at 1 investigative sites in the United States from 18 March 2015 to 04 May 2017.|Healthy volunteers were enrolled to receive TAK-020 oral solution Single Rising Doses (SRD) [0.1, 0.5, 2.5, 4.4, 8.8, 17.5, 35, 70, 105 milligrams (mgs)] or placebo in Part 1 or Multiple Rising Doses (MRD) [3.75, 5.75, 13, 25, 45, 60 mgs] or Placebo in Part 2.
721906|NCT02413229||
721907|NCT02413203||
721908|NCT02413190||
721909|NCT02413151||
721910|NCT02413047||
721911|NCT02413034||
721912|NCT02413008|The study had an initial safety phase of the trial started on March 30th, 2015; the treatment phase of the trial started in October 16th, 2015 and the study ended globally on February 10th, 2017|After Inform Consent signature and prior randomization the following data was collected for subject's eligibility: Medical and surgical history and demographics; physical examination, ECOG PS, hematology, blood chemistry, urine test, transvaginal ultrasound, Blood (serum) samples for FSH and LH determination and evaluation of vaginal dryness.
721913|NCT02412878|Participants were enrolled from September 2015 to August 2016 at 118 sites in Australia, New Zealand, Japan, North America, and Europe.|"Participants were randomized in a 1:1 ratio to receive a regimen consisting of either once-weekly or twice weekly carfilzomib in combination with dexamethasone.
~Randomization was stratified by International Staging System (ISS) stage (stage 1 vs stages 2 or 3), refractory to bortezomib treatment (yes vs no), and age (< 65 vs ≥ 65 years)."
721914|NCT02412852||
721915|NCT02412761|From June 2013 until July 2016, 55 patients were eligible based on inclusion/exclusion criteria, and 42/55 patients (76%) agreed to participate.|Forty-two children agreed to participate. Among the 30 patients taking antihypertensive medication prior to enrollment, 20 completed an updated baseline ambulatory BP monitoring. As a result, 23% (7/30) were found to be normotensive without medication, and did not undergo an n-of-1 trial. These 7 patients were not assigned to a treatment arm.
721916|NCT02412722|Participants took part in the study at 4 investigative sites in United States from 26 March 2015 to 31 May 2018.|Participants were enrolled in 3 cohorts in the study: 1)Single-Agent QD Arm, 2)Combination Arm and 3)Single-Agent QW Arm. Participants in Single-Agent QD Arm first completed pharmacokinetic (PK) run-in period, to assess the effect of dosing condition (ie, fed vs fasted) and manufacturing process (ie, milled vs unmilled API) on PK of sapanisertib.
721917|NCT02412657||
721918|NCT02412644|Recruitment May 28 2015-November 2015 through practice database|
721919|NCT02412501||
721920|NCT02412488||
721921|NCT02412436|Study participants were recruited at five ACTG Clinical Research Sites in four countries (two sites from South Africa and one site from each of Botswana, Kenya, and Zimbabwe) between November 2015 and March 2017.|Of the 85 women screened, 62 were deemed eligible and enrolled into this single-arm study.
721922|NCT02412371|This study enrolled 48 participants at 10 sites in the United States. The study was designed as a 2-phase study consisting of a Phase 1, dose escalation of veliparib in combination with concurrent chemoradiotherapy (CRT) and consolidation chemotherapy (CT) and a Phase 2, randomized, double-blinded study.|"Participants in Phase 1 were sequentially assigned to ascending dose levels of veliparib in combination with carboplatin/paclitaxel chemoradiotherapy. Phase 2 was not conducted since there was a change in standard of care for newly diagnosed, unresectable Stage III non-small cell lung cancer (NSCLC).
~Results are reported for Phase 1."
721923|NCT02412306|Study was conducted at 16 centers in Japan. Cohort enrollment periods were: adult phase 1b, from 04 Jun 2015 to 13 Jan 2016; pediatric phase 1b, from 17 Feb 2016 to 20 Jun 2016; adult phase 2, from 11 Apr 2016 to 12 Jun 2017; adult expansion cohort, from 04 Dec 2017 to 13 Nov 2018; pediatric expansion cohort, from 05 Nov 2017 to 05 Sep 2018.|After a 2-week screening and pre-phase period, participants were treated in an open-label phase 1b part (adult or pediatric), a phase 2 part (adult), or in an expansion cohort (adult or pediatric).
721924|NCT02412111||The study consisted of 2 periods: an Ivacaftor Run-in Period and an Active Comparator Treatment Period. Participants were randomized in a ratio of 1:1 to receive either VX-661/ivacaftor combination therapy or ivacaftor monotherapy for 8 weeks during the Active Comparator Treatment Period after completion of 4 weeks Ivacaftor Run-in Period.
721925|NCT02412098|Participants were enrolled at study sites in United States, Romania, Germany, and New Zealand. The first participant was screened on 19 March 2015. The last study visit occurred on 22 April 2016.|91 participants were screened. No participants were enrolled in the severe hepatic impairment (cohort 2) arm.
721926|NCT02411929||
721927|NCT02411747||
721928|NCT02411643||
721929|NCT02411591||The study has 2 parts (Part A and Part B). Part A is a dose-escalation study to determine the recommended dose of abemaciclib in combination with necitumumab Part B (expansion cohort). Completers completed the 2 cycles, with required assessment, had progressive disease or died due to any cause, alive and on study at conclusion but off treatment.
721930|NCT02411578||26 consented for Run-in; 1 ineligible after consent; 2 ineligible after Run-in phase; 3 withdrew
721931|NCT02411565|Participants were enrolled at Moffitt Cancer Center March 2016 through February 2017.|
721932|NCT02411539|The first participant enrolled to the study on August 25th, 2015 and the last participant enrolled on March 4th, 2016. A total of 13 U.S. sites enrolled participants.|
721933|NCT02411461||
721934|NCT02411448||"This study consists of 3 parts:
~Part A: Open-label.
~Part B: Randomized, double-blind and placebo-controlled.
~Part C: Open-label.
~Part C data will be reported after study completion."
723188|NCT02301364|Protocol Open to Accrual 11/20/2014 Protocol Closed to Accrual 03/22/2/016 Primary Completion Date 10/11/2016 Recruitment Location is the medical clinic|
721935|NCT02411396|There are a total of 483 adult patients with sickle cell disease (SCD) enrolled from the end of April 2015 to December, 2016. 145 from Johns Hopkins (JH), 101 from Case Western (CW), 110 from Our Lady of the Lake Hospital (OLL) and 127 from Blood Center of Wisconsin (BCW). Four hundred forty two patients have completed 18 months follow up|
721936|NCT02411292||
721937|NCT02411201|A total of 51 children aged less than 2 years were recruited in 4 countries: Austria, France, Hungary and Poland.|
721938|NCT02411110||
721939|NCT02411084|Out of the 29 sites selected (USA, France, Italy, Spain, Switzerland, UK, Germany) for participation in this study, 22 of them have activated screening and enrolment procedures, and 15 sites have effectively enrolled and randomized participants in the study. The first site approved was in Spain on 07 October 2015.|Out of 184 subjects planned, 37 subjects were screened and 36 subjects were randomized by IVRS in a 1:1 ratio. All subjects signed the informed consent and met all eligibility criteria except one case that had an incomplete screening procedure (some blood tests have not been performed for the screening visit as requested by the protocol).
721940|NCT02410967||"Trial Period: Treatment Phase (4 Weeks) Total Started: 53 [Protocol Enrollment: 53]
~Trial Period:Follow-up Phase (8 Weeks) Total Started: 48"
721941|NCT02410824||7 subjects discontinued before lens randomization due to screen failure.
721942|NCT02410811||
721943|NCT02410707||
721944|NCT02410629||
721945|NCT02410577||
721946|NCT02410551|Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Ploycythemia Vera or Essential Thrombocythemia that are 18 to 70 years old that want to pursue a transplant. They start the Pacritinib per-transplant and can proceed to transplant 60 days after starting Pacritinib but no more than 180 days.|
721947|NCT02410382||Study was terminated and data coordinator is no longer in the institution. Sincere efforts were made to gather and report the data, however, no data are available since the study records cannot be located.
721948|NCT02410343|"Of the 46 patients screened, 14 patients at 10 centers located in the US and Europe (Austria, Greece, Hungary) met entry criteria and were considered eligible for randomization. Of the 32 patients not randomly assigned to study treatment, 26 were excluded on the basis of inclusion/exclusion criteria and 6 were excluded for other reasons."|Participants were randomly allocated to 1 of 2 treatment groups (TV-1106 or placebo) in a 2:1 allocation to prevent selection bias.
721949|NCT02410291|Participants were recruited at their initial appointment date or via telephone by our trained research assistant (RA). The RA presented the study rationale to the patients and those who consented were randomly assigned to either the multimedia group or the pamphlet group.|
721950|NCT02410278|Participants were recruited from 50 sites in the United States.|Participants were screened over 2 weeks. Those who met ≥1 of the following criteria were considered screen failures: a score of ≥5 on 1 question for 1 day on the Gastrointestinal Symptom Rating Scale (GSRS), ≥4 or ≥3 on 1 question for 2 or 3 consecutive days, respectively; and eDiary compliance of <75% over 14 days prior to randomization.
721951|NCT02410252|Adolescent-Caregiver dyads were recruited from the MGH Pediatric Cancer Center or the MGH Hospital for Children (Surgical Division). Recruitment began in early 2015 and was completed by April of 2017.|
721952|NCT02410213||
721953|NCT02410200||
721954|NCT02410161||
721955|NCT02410018||
721956|NCT02409927||
721957|NCT02409914|Women with PCOS diagnosed during a clinical examination using the Rotterdam criteria were recruited.|
721958|NCT02409784|Participant were recruited with advertising poster on bulletin board of different local organism (university, health clinic, sport and leisure association, etc)|
721959|NCT02409732|Twenty four patients were screened to participate. Three men and one woman did not meet criteria to participate in the study.|Twenty four patients were screened to participate, but only 20 entered into the study (3 men and 1 woman screen failed). This was an open label proof of concept study and our goal was to enroll a total of 20 patients, which we achieved.
721960|NCT02409719|"Recruitment was held in the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment requires surgery in which the recruitment process started June 2014 until January 2019.
~The objective was to recruit 76 patients were randomly divided into two groups."|6 patients were lost to follow up.
721961|NCT02409667||The screening period was up to 4 weeks and rescreening was allowed for an unlimited number of times. At the Screening Visit, every patient was registered in an Interactive Response Technology and the Investigator ensured that the patient fulfilled all the inclusion/exclusion criteria
721962|NCT02409459||
721963|NCT02409355||
721964|NCT02409329||6 participants were administratively withdrawn prior to randomization; 5 were unreachable during a pre-determined run-in period after enrollment, 1 behaved inappropriately with a research assistant during enrollment
721965|NCT02409277||
721966|NCT02408965||Determined ineligible (n=28) Patient withdrew (n=6) Administrative error (n=2)
721967|NCT02408796||
721968|NCT02408692||
721969|NCT02408523|The study started to enroll patients in April 2015 and concluded in May 2019.|"Completed study was defined as meeting any exit criteria or completing the 24-week Treatment Period with < 2 PGTCS. After Treatment Period participants enrolled either in a 4-week Transition Period (entered EP0012) or up to a 4-week Taper Period and a 30-day Safety Follow-up Period (did not enter EP0012).
~Participant Flow refers to the Safety Set."
721970|NCT02408484||
721971|NCT02408445||
721972|NCT02408315||
721973|NCT02408263||
721974|NCT02408198||
721975|NCT02408068||
721976|NCT02407756|The study was conducted at 25 sites in 6 countries. A total of 88 participants were screened, and of those, 78 participants were randomized with 77 being treated. Ten participants were screen failures as 5 were due to exclusion criteria met & inclusion criteria not met, 4 participants withdrew consent and 1 participant was lost to follow-up.|A total of 40 adolescents (aged ≥12 to <18 years) and 38 children (aged ≥6 to <12 years) were enrolled and randomized to 2 sequential ascending dose cohorts: Cohort 1 (2 mg/kg) and Cohort 2 (4 mg/kg).
723189|NCT02301299||
723190|NCT02301169||
723191|NCT02301143||152 patients were screened and 107 participants enrolled.
721977|NCT02407704||Participants were diagnosed using the SCID, and were excluded from participation if they did not meet criteria for Major Depressive Disorder. Participants were also excluded for presence of bipolar or psychotic disorders, alcohol/substance dependence within the past 3 months, or if they could not complete MRI.
721978|NCT02407457||
721979|NCT02407249||
721980|NCT02407236|Out of 961 randomized participants, 783 participants (523 randomized + 260 non-randomized) had clinical response in induction study and entered maintenance study (523 participants were considered as primary population for maintenance study).|Per planned analysis, all efficacy outcome measures are based on the primary population for Maintenance study. Results are reported up to data cut-off date 12 Aug 2018.
721981|NCT02407223||A total of 356 participants were randomized and received treatment (116 participants to placebo, 118 participants to ustekinumab 45 milligram [mg], and 122 participants to ustekinumab 90 mg).
721982|NCT02407132||
721983|NCT02407041||
721984|NCT02406937||
721985|NCT02406885||
721986|NCT02406677|Study recruited patients on P2Y12 inhibitor therapy with US-based health insurance. Recruitment into 301 study sites (hospitals) in the US was conducted from June, 2015 to September, 2016. The study evaluated whether patient copayment reduction significantly influenced antiplatelet therapy selection and long-term adherence.|The study population included patients STEMI or NSTEMI who were treated with a P2Y12 receptor inhibitor. After patient enrollment into hospitals, each hospital was randomized into either the intervention or the control arm (cluster randomization). The randomization scheme was changed from 1:1 to 2:1 mid-study. 12 month study duration.
721987|NCT02406612||
721988|NCT02406586|Subjects recruited from July 2009 to January 2011 at Grady Memorial Hospital.|All subjects will receive IV Intralipid (20% solution at 20 ml/hour) prior to randomization.
721989|NCT02406573||
721990|NCT02406495||
721991|NCT02406443||
721992|NCT02406261|It was planned that all subjects in Cohort B would be enrolled at Site 002.|
721993|NCT02406248|This study was conducted at 13 centres in Taiwan. The first patient was enrolled on 23 April 2015 and the last visit of the last patient took was on 9 February 2017. Informed consent was received for 113 patients|Out of the patients who provided informed consent 95.6 % (n=108) of the patients received study drug. 8 patients provided informed consent but did not fulfill eligibility criteria, out of whom 5 did not receive treatment and 3 received treatment.
721994|NCT02406027||Participants who completed their treatment period as described under the parent protocol in study 54861911ALZ2002 (NCT02260674) or any ongoing/future Phase 1b or Phase 2 atabecestat clinical study were enrolled in this study.
721995|NCT02405962|This study enrolled parents of children aged 3-12 years who had been diagnosed with asthma from 2 pediatric respiratory outpatient clinics, the Ambulatory Care Centre and a nurse-led asthma clinic, in the Department of Pediatrics and Adolescent Medicine of a public hospital under the Hospital Authority in Hong Kong.|No significant events in this study occurred after participant enrollment. All the enrolled participants who provided written consent to participate in the study were included in the study.
721996|NCT02405780||
721997|NCT02405442|Participants were enrolled at study sites in North America, Europe, South Africa, and Asia Pacific. The first participant was screened on 30 April 2015. The last study visit occurred on 22 December 2016.|315 participants were screened.
721998|NCT02405429||
721999|NCT02405390||
722000|NCT02405195||
722001|NCT02405091|This study enrolled participants with clinical diagnoses of schizophrenia or schizoaffective disorder or mood disorder with neuroleptic-induced tardive dyskinesia (TD) from 45 centers in North America and Puerto Rico.|
722002|NCT02404792||
722003|NCT02404649|Recruitment of patients were fulfilled in a timely manner. Patients were were down from the existing patient pool at the Harvard School of Dental medicine.|Three participants were excluded from the trial due to early dental implant failures. These three events were caused by local infections and thus subsequent readings were not taken.
722004|NCT02404610||
722005|NCT02404545||
722006|NCT02404532|This sub-study was conducted on 29 healthy male and female participants at a single site (clinic) in United States (US). All enrolled participants received study treatment for 1 day (Visit 1), plus a 1-week (7 [+1] days after the last trial visit) safety follow-up period (via phone call).|A screening period of 14 days included various procedures such as informed consent form signing, urine pregnancy test, study eligibility review, vital signs measurement, medical history, concomitant medication, baseline & demographic data collection, physical measurement, drugs of abuse test & any adverse events (AEs) assessments.
722007|NCT02404493||
722008|NCT02404389|A total of 82 patients, male and female of non-childbearing potential aged 18-75 years, with Actinic Keratosis (AK) on the face or balding scalp were enrolled in the study.|
722009|NCT02404350|Study was conducted at 173 centers in 28 countries.|996 were randomized and dosed, of which 932 participants completed 24 weeks of treatment. Out of the 64 participants who discontinued the most common reasons were participant/guardian decision (32) and adverse events (16).
722010|NCT02404311||Participants who received all vaccinations in Part A and completed Part A as scheduled were eligible for the Part B extension study. N=63 vaccination recipients in Part A (Group 1) were re-randomized to Part B Group 1a or 1b with a 1:1 ratio, while N=7 placebo recipients from Part A (Group 2) re-enrolled to receive placebo injections in Part B.
722011|NCT02404285||Subjects were enrolled in the study after signing informed consent and meeting inclusion/exclusion criteria per protocol. A Washout period of 2-3 weeks was initiated for subjects discontinuing topical acne or systemic acne treatment respectively to normalize by washing their face twice a day with the study facial cleansing soap.
722012|NCT02404220|Participants were enrolled at study sites in Germany, Canada, and United States. The first participant was screened on 06 May 2015. The last study visit occurred on 17 December 2018.|42 participants were screened.
722013|NCT02404168||
722014|NCT02404103||
722015|NCT02404025|10 subject started eltrombopag, and 1 subject was withdrawn from the study before starting eltrombopag, as he did not meet the eligibility criteria prior to receiving eltrombopag.|
723192|NCT02301039||
727605|NCT01961271||
727606|NCT01961167||
722016|NCT02403999|All the participants were recruited from one center in United Kingdom.|A total of 32 participants were screened and enrolled in the study, out of which 31 participants were randomized to the study and 1 participant was screening failure as participant did not meet study criteria.
722017|NCT02403986||
722018|NCT02403895|First subject enrolled: 15 April 2015 Last subject last visit: 29 December 2016 The study was performed at 7 centres: 4 USA, 2 Spain, 1 Germany Patient population: Patients with squamous non-small cell lung cancer with relapsed or refractory disease for whom weekly paclitaxel is an appropriate treatment choice|11 patients were enrolled Patients were assigned to treatment if they met all of the inclusion criteria and none of the exclusion criteria.
722019|NCT02403830|Between August 2015 and April 2016 a total of 34 patients were recruited and consented at the University of Florida Health Science Center at UF Health Jacksonville - Division of Cardiology.|Four subjects withdrew their consent before randomization and did not receive study drug. Therefore a total of 30 patients were randomized.
722020|NCT02403817||
722021|NCT02403778||
722022|NCT02403674|Treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection have been recruited at 126 study sites worldwide. The present results are based on the first 48 weeks of this ongoing 96-week study.|
722023|NCT02403635|Participants took part in the study at one investigative site in United Kingdom from 18-March 2015 to 28-May 2015|
722024|NCT02403479||
722025|NCT02403271||
722026|NCT02403206|Subjects were recruited from 14 investigative sites: 1 located in Greece, 4 located in India, 2 located in Mexico, 1 located in the Philippines, 3 located in Romania, and 3 located in the US.|Of the 406 enrolled, 6 subjects were exited as screen failures and 10 withdrew prior to randomization. This reporting group includes all randomized subjects (390).
722027|NCT02403180|Participants were recruited from one investigational center located in Spain.|This reporting group includes all enrolled participants (70).
722028|NCT02403154||
722029|NCT02402933|Participants and their principal caregiver(s) (such as parents, family member, roommate, teacher, and coach) were trained in the use of nasal glucagon.|
722030|NCT02402907||1356 were enrolled, 14 did not undergo procedure at Sinai, leaving 1342 participants (672 in experimental group and 670 in placebo group) that continued on the study.
722031|NCT02402881|16 medical and surgical hospital units were included, intensive care units were excluded. Convenience sample of 4 units (2 surgical and 2 medical) received the intervention. The remaining 12 units (5 surgical and 7 medical) served as control and received no intervention. Pre-Intervention data were retrospectively assessed|
722032|NCT02402764|Participants were enrolled at Moffitt Cancer Center between July 2015 and January 2016.|
722033|NCT02402452|Participants were enrolled at study sites in the United States, Germany, and New Zealand. The first participant was screened on 05 May 2015. The last study visit occurred on 28 September 2015.|39 participants were screened.
722034|NCT02402322|Participants were recruited through advertisements on the Internet and were redirected to a website containing information about the study. Individuals interested in taking part in the study completed a screening questionnaire and provided demographic data. Participants were recruited between August, 2013 and February 2014.|"Individuals were evaluated thoroughly using the MINI International Neuropsychiatric Interview.
~One hundred and twenty-five individuals were assessed and 48 were excluded from the trial because they suffered from another disorder (n=34), their medication was not stable (n = 13), or they had received Cognitive Behavioral Therapy (n = 1)."
722035|NCT02402296||
722036|NCT02402218|Participants were enrolled between August 2015 and October 2016 at an outpatient clinic in Baltimore, MD, USA.|
722037|NCT02402166|The study was conducted at seven sites in the United States between 15 Apr 2015 (first participant first visit) and 30 Jun 2016 (last participant last visit).|A total of 24 participants were enrolled and received at least one dose. Overall 19 participants completed the study.
722038|NCT02402153||
722039|NCT02402127|Participants were recruited from three investigational centers located in the United States.|All enrolled participants (24)
722040|NCT02402062||Meeting eligibility criteria: 17 patients that meet the eligibility criteria were finally included
722041|NCT02402036||
722042|NCT02401867||
722043|NCT02401672|Assessed for eligibility (n=327), Excluded 280, Not meeting inclusion criteria: 275, and declined to participate: 5, lost contact before screening visit: 5|
722044|NCT02401555||
722045|NCT02401542||
722046|NCT02401529||"116 participants were initially considered for the study. However, only 100 were considered in the final results. some were excluded due to not matching inclusion criteria. others failed to attend follow up visits, adhere to treatment protocol or complete the questionnaire as required.
~Please refer to section ( period 1) for further details."
722047|NCT02401464|Participants took part in the study at 1 investigative site in Japan from 25 March 2015 to 26 May 2015.|Healthy participants were enrolled in 1 of 2 treatment sequences: Sequence a (dry syrup): TAK-536 dry syrup followed by TAK-536 tablet; Sequence b (dry syrup): TAK-536 tablet followed by TAK-536 dry syrup; Sequence a (granules): TAK-536 granules followed by TAK-536 tablet; Sequence b (granules): TAK-536 tablet followed by TAK-536 granules.
722048|NCT02401412||
722049|NCT02401256|"A total of 70 volunteers were enrolled study, 53 completed the whole study and 17 subjects withdraw from the study (6 during Phase 1, 6 during Phase 2 and 5 during Phase 3).
~We did include on the data analysis 8 volunteers that withdraw from the study but had Efavirenz quantification information and CYP2B6 genotypes (Analysed volunteers = 61)"|
722050|NCT02401230|Participants were recruited March 2015 through November 2016.|Of the 86 subjects consented for study participation, 76 were randomized to a study intervention.
722051|NCT02401048||While the study include Phase 1b and 2, the dosing was not changed between phases (following the study design because there were no DLTs and thus no dose adjustments in from Phase 1b to Phase 2). Thus the study data were reported with Phases 1b and 2 combined.
722052|NCT02401022||
722053|NCT02400996|An analysis from a prospectively maintained database of patients was done who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs|
722054|NCT02400905||
722061|NCT02400333|This study was conducted at PAREXEL International, Early Phase Clinical Unit Berlin, Berlin, Germany. In this study, 100 participants were screened, out of which 36 were randomized and treated.|Participants were randomized in 4 sequence Williams design for 4 periods and 4 treatments:Ticagrelor orodispersible (OD) tablets with water (Treatment A);Ticagrelor OD tablets without water (Treatment B);Ticagrelor OD tablets suspended in water through nasogastric tube (Treatment C);Ticagrelor immediate-release (IR) tablets with water(Treatment D).
722062|NCT02400307|Participants were enrolled at study sites in the United States and New Zealand. The first participant was screened on 17 April 2015. The last study visit occurred on 13 July 2015.|49 participants were screened. No participants were enrolled in the moderate or mild renal impairment adaptive cohorts as a review showed that PK data collected were sufficient to detect any differences between the 2 renal function groups.
722063|NCT02400073|A total of 122 patients (25 from Spain and 97 from Germany) were enrolled in the study|
722064|NCT02399917|Recruitment Period: May 2015 - June 2017|
722065|NCT02399345|A total 10 participants were enrolled in the first arm (ombitasvir/paritaprevir/r, dasabuvir, and SOF plus RBV for 6 weeks); based on inadequate efficacy in the first arm, subsequent arms (4 weeks of treatment; with or without RBV) were not enrolled per protocol.|
722066|NCT02399254||
722067|NCT02399163|Participants were recruited at one center in United States of America.|A total of 80 participants were screened. Of the 80 participants, 62 were randomized and 53 completed the study.
722068|NCT02399111||
722069|NCT02399085||
722070|NCT02398409|The number of recruited participants (143) is slightly different from the number of participants represented in the flow diagram (137) due to the fact there were 6 participants after recruitment and informed consent we were not able to reach them for data collection.|"Veterans and Caregiver were enrolled as dyads. Participants refers to the Dyads."
722071|NCT02398227||
722072|NCT02398188||
722073|NCT02397954||
722074|NCT02397915|This was a single-dose, cross-over participant (par.) preference study, where participants with seasonal allergic rhinitis or perennial allergic rhinitis were randomized, in ratio of 1:1, to receive fluticasone furoate (FF) nasal spray and mometasone furoate (MF) nasal spray.|
722075|NCT02397837||Protocol enrollment of 103 is the total number of participants who signed a consent form. 63 were randomized to a treatment group. The discrepancy between 103 and 63 is the total number of participants who completed a screen visit but failed to randomize (N=40).
722076|NCT02397785||
722077|NCT02397707|Participants were enrolled at study sites in United States, Germany, and New Zealand. The first participant was screened on 24 March 2015. The last study visit occurred on 04 March 2016.|54 participants were screened. 33 participants were enrolled, 14 participants with normal hepatic function, 10 with Moderate Hepatic Impairment (MHI), and 9 with Severe Hepatic Impairment (SHI). Five of the same participants with normal hepatic function served as matched controls for the MHI and SHI Arms/Groups.
722078|NCT02397694|Participants were enrolled at 22 centers in the United States of America.The first participant was screened on 23 March 2015 and the last study visit occurred on 27 February 2019.|125 participants were screened.
722079|NCT02397655||
722080|NCT02397564||
722081|NCT02397473||
722082|NCT02397447||
722083|NCT02397408|Patients were recruited from the Division of Radiation Oncology, Division Urological Medical Oncology, and the Division of Urologic Surgical Oncology at the Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco (UCSF) who are planning to undergo radical prostatectomy of definitive radiation therapy.|
722084|NCT02397265|24 participants were recruited (due to 4 withdrawals before randomization) to reach a total n=20 for the study. Only 6 were randomised/completed due to sufficient data, rest of 14 people did not do the study. 6 people were randomized and completed the study for each arm. The interventions were in random order according to the randomisation.|
722085|NCT02397122||Fifty-eight patients that did not comply with the inclusion criteria were not chosen for the study
722086|NCT02397096|Out of 852 participants screened, 673 were randomized to study treatment, and 670 were treated. There were 122 global study sites utilized.|This report covers results for the 48-week base study plus follow-up (up to 50 weeks). Results for the ongoing open-label study extensions will be reported when the extensions are completed.
722087|NCT02396953|This was an open-label, dose-ascending study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of a single dose of lanreotide prolonged release formulation (PRF). 17 centres recruited adult subjects with acromegaly into 3 lanreotide PRF treatment cohorts (180 milligrams [mg], 270 mg and 360 mg).|Screening of subjects took place 28 to 42 days before administration of study treatment (Day -42 to Day -28). Overall, 60 subjects were screened during this run-in period; 32 of whom were screening failures and 28 subjects were enrolled and treated with lanreotide PRF.
722088|NCT02396745||
722089|NCT02396732||
722090|NCT02396537||
722091|NCT02396511||
722092|NCT02396420|Following FDA and IRB approval for the study, recruitment began and the first subject was enrolled for the study on September 24, 2015. Enrollment was closed on June 29, 2017.|The study involved a screening period during which patient eligibility was determined. There were no screen failures.
722093|NCT02396381||"Following randomization of 984 subjects, from 1039 enrolled subjects, one clinical site was terminated from this study due to non-GCP compliance.
~The safety population of 1012 subjects included all enrolled subjects except 27 subjects from the terminated site."
722094|NCT02396316|Study was conducted at nineteen study centers in Japan, between 02 April 2015 (first subject first visit) and 06 Sep 2016 (last subject last visit).|A total of 63 subjects were screened and 54 subjects were randomized into the aflibercept group (N=27) and the sham group (N =27).
722095|NCT02396251||
722096|NCT02396212|It was planned to enroll approximately 20 patients in this study. There were19 patients enrolled and data from all patients were analyzed.|
722097|NCT02396160||
722135|NCT02392624||A total of 206 participants were enrolled in the study, but only 205 participants received at least one dose of any study treatment. Results include only the treated 205 participants.
723231|NCT02298179|Subjects were enrolled from one site in Belgium.|All subjects enrolled were included in the trial.
722098|NCT02396147|Participants took part in the study at 1 investigative site in the United States from 02 March 2015 to 11 June 2015.|Healthy participants were enrolled equally in 1 of 2 treatment arms each with 6 sequences that determined the order of administration of TAK-385 tablet formulations. Arm 1: T2 fasted, T4 B fasted or T4 B fed and Arm 2: T2 fasted, T4 C fasted or T4 C fed.
722099|NCT02395978|Subject were recruited over a 49-month period from April of 2015 to March of 2019 at 5 studies sites in Taiwan and 1 study site in the United States.|
722100|NCT02395822||
722101|NCT02395692||1 subject withdrew before start of study
722102|NCT02395666||
722103|NCT02395653|Pediatric participants from 12 to less than 18 years of age who had undergone general or regional anesthesia for elective abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery.|Screening within 3 weeks of study start included review of inclusion/exclusion criteria, informed consent signature, medical history, height, weight, vital signs, American Society of Anesthesiologists physical status, and a review of the Separated System With Enhanced Controller (SSEC) for delivery of 40 micrograms (mcg) fentanyl/dose.
722104|NCT02395627||
722105|NCT02395536|525 subjects were assessed for eligibility|4 subjects excluded prior to randomization for not meeting inclusion/exclusion criteria
722106|NCT02395471||
722107|NCT02395302||
722108|NCT02395185|53 participants were assessed for eligability. 33 patient participants and their guardians were enrolled in the study from 3/13/13 to 9/17/14 at their initial clinical visit. A total of 131 casts were performed.|
722109|NCT02395172||First participant signed informed consent: 24 Mar 2015, Clinical data cut-off: 04 March 2019.
722110|NCT02395133|The study was conducted in 15 countries between 25 March 2015 and 18 October 2016. A total of 422 participants were randomized in the study.|Out of the 475 participants, 422 were randomized and 420 received either placebo or Dupilumab. Participants were randomized in 2:1:1:1 ratio to receive Dupilumab 300 milligram (mg) once weekly/twice weekly (QW/Q2W), Dupilumab 300 mg four times a week (Q4W), Dupilumab 300 mg eight times a week (Q8W) and Placebo.
722111|NCT02395055||
722112|NCT02395042||
722113|NCT02394951||
722114|NCT02394925||A total of 113 enrolled into this study. Of the enrolled, 5 subjects did not meet the eligibility criteria and 108 subjects were dispensed the study lens. Of the dispensed subjects 79 completed the study while 29 subjects were discontinued.
722115|NCT02394912||This was a prospective, single-arm, multicenter clinical study to evaluate the safety & effectiveness of the LUMIFI with Crux VCF system. The study included enrollment into a roll-in phase Cohort A consisting of 2 subjects/ site to assure compliance with the Investigational Device prior to enrolling into Cohort B, the treatment phase.
722116|NCT02394808||A total of 54 subjects were enrolled in this study. Of the enrolled subjects all 54 were dispensed a study lens. Of the dispensed 52 completed the study while 2 were discontinued.
722117|NCT02394756||A total of 52 subjects were enrolled in this study. Of the enrolled subjects 10 subjects did not meet the eligibility criteria and 42 subjects were dispensed study lenses. Of the dispensed subjects 37 completed the study while 5 subjects were discontinued.
722118|NCT02394730|Participants were screened and randomised from 2 sites in USA and 5 sites in Australia.|125 were screened and 60 were not randomised (55 ineligible, 4 lost to follow up and 1 withdrew consent prior to randomisation).
722119|NCT02394665||Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.
722120|NCT02394600||
722121|NCT02394561||Five hundred thirty participants were screened and 434 entered the CORE Phase. However, there were 3 patients without Cw6 assessment which was necessary for stratification to the two arms, therefore 431 were considered enrolled.
722122|NCT02394548||One participant was consented but never began treatment
722123|NCT02394457|29 were consented, of these 28 patients met study criteria and were randomized|
722124|NCT02394340||
722125|NCT02393950|Healthy male volunteers were recruited|"Screening : Male subjects were screened and following PE, vital signs, EEG, ECG and lab. assessments were randomised into the study.
~Sixteen subjects were randomised to 2 panels of 8, each subject received 3 single doses of ODM-106 and 1 dose of placebo in a randomised crossover design.
~Panel 1 was completed before Panel 2 commenced dosing."
722126|NCT02393859|"This study was conducted at 47 centers across 13 countries (Europe, Australia, Israel). The first participant was enrolled on 10 November 2015.The last participant enrolled on 30 August 2019.
~Data cutoff for the primary analysis data presented here was 17 July 2019."|"After a 3-week screening period, participants were enrolled and randomized 1:1 into 1 of 2 treatment groups: High Risk Consolidation 3 (HC3) or Blinatumomab.
~Randomization was stratified by age and bone marrow/minimal residual disease (MRD) status."
722127|NCT02393755||
722128|NCT02393677||
722129|NCT02393547|Subjects were recruited from the community surrounding Mayo Clinic (Rochester, MN) between September 2013 and July 2014. Overweight or obese daily smokers who were interested in stopping cigarette use were recruited through the news media and local advertisements in Rochester, MN.|The current study included an initial telephone screen.After the initial screen, eligible subjects were invited to come for potential enrollment. Visits prior accrual (drug dispensing) included an information meeting (screening, physician physical exam, and informed consent) and baseline visit (screening, baseline measures and drug dispensing).
722130|NCT02393417||Screen Fail Rate of 30% - 12% due to warts not meeting criteria, 12% due to DTH measurement not meeting criteria, 5% other reasons.
722131|NCT02393378|Participants took part in the study at 5 investigative sites in Estonia and Russian Federation from 08 April 2015 to 03 November 2016.|Participants with a diagnosis of rheumatoid arthritis were enrolled in 2:1 ratio to receive either namilumab combined with methotrexate (MTX) or adalimumab combined with MTX.
722132|NCT02393209|Participants took part in the study at 5 investigative sites in United States and 1 in Canada from 03 June 2015 to 20 January 2017. The Phase 2 portion of the study was cancelled by the sponsor.|Participants with a diagnosis of metastatic non-small lung cancer were enrolled in a dose escalation study and received one of 2 doses: TAK-117 (200 mg) plus docetaxel or TAK-117 (300 mg) plus docetaxel.
722133|NCT02392806||
722134|NCT02392767|Cross-over study|
722136|NCT02392611|Participants were enrolled at study sites in United states. The first participant was screened on 16 March 2015. The last study visit occurred on 11 October 2017.|37 participants were screened.
722137|NCT02392559|Participants were enrolled from 24 March 2016 to 30 May 2019 at 8 research centers in North America, 30 research centers in Europe, 6 research centers in Latin America, and 3 research centers in Asia Pacific.|Participants were randomized in a 2:1 ratio to receive 24 weeks of monthly (QM) evolocumab or placebo. Randomization was stratified by screening low-density lipoprotein cholesterol (LDL-C; < 160 mg/dL vs ≥ 160 mg/dL) and age (< 14 years vs ≥ 14 years).
722138|NCT02392507||Participants with known best overall response and off study treatment were considered to be completed.
722139|NCT02392494||Nine participants were enrolled and allocated to single doses of either 100, 200, or 400 mg of MK-1075. As per the protocol, planned Panel D (800 mg MK-1075) was not enrolled since the study objective was achieved in Panel C.
722140|NCT02392481|This is a non-interventional, prospective, exploratory study. Asthma severity (mild, moderate or severe) was determined on the basis of medication use, spirometry (Forced Expiratory Volume in one second (FEV1) predicted values) and exacerbation history.|
722141|NCT02392403||
722142|NCT02392377||
722143|NCT02392351||
722144|NCT02392286||
722145|NCT02392247||
722146|NCT02392234|A total of 248 participants were enrolled. Out of which, 246 received at least 1 dose of study drug were included in safety set and 244 participants who carried intended cystic fibrosis transmembrane conductance regulator (CFTR) mutations were included in Full analysis set.|Participants were randomized to 1 of 6 treatment sequences, each of which included 2 treatment periods and 2 of 3 potential treatments (placebo, VX-661/ivacaftor [IVA], IVA). Treatment periods were separated by an 8 week wash-out period.
722147|NCT02392208|Recruitment commenced on 07/07/15 at the University of Michigan outpatient dialysis clinics. The final participant enrolled in the study on 02/09/16.|All 8 participants followed a crossover study design and completed study arm 1 (telavancin before hemodialysis) followed by a 14-day minimum wash out then study arm 2 (telavancin after hemodialysis).
722148|NCT02392195||
722149|NCT02392104||
722150|NCT02392000||
722151|NCT02391987||
722152|NCT02391961||(4) subjects were enrolled, but did not pass initial screening procedures at study visit 1 and therefore were not assigned to a study group.
722153|NCT02391948|"Study Population: Children with cerebral palsy of gross motor delay, ages 18 month to 11 years, and their parents.
~Sampling Method: Non-Probability Sample. Participants Recruited for 2-Visit or 5-Visit Study."|"N=724 participants agreed to participate in the study following completion of the informed consent process. The number of participants Started (N=708) is different from the number of participants Enrolled (N=724) because N=16 were Enrolled, and Not Started for the following Reasons:
~Death = 1. Lost to Follow-up = 4. Ineligible = 11."
722154|NCT02391714||
722155|NCT02391701||
722156|NCT02391584||
722157|NCT02391545||
722158|NCT02391363|Recruitment occurred from February 2015 through October 2016 in community settings where older adults gather and/or receive services such as social service agencies, churches, senior housing and community centers.|Prior to random assignment, participants were screened at three separate times. During this process, 84 participants were ineligible due to presence of exclusionary criteria, 24 were lost to follow-up and 5 withdrew from the study.
722159|NCT02391350|Participants were recruited from February 2015 through October, 2018. Recruitment was done in 2 health systems (University of Utah and Intermountain Healthcare) in Salt Lake City, Utah. Potential participants were identified using electronic health records and were sent a letter about the study after completing a primary care visit. A research team made follow-up telephone calls to identify those interested in meeting with a research assistant to determine eligibility and provide consent.|
722160|NCT02391311|Protocol Open to Accrual: March 2015, Primary Completion Date: January 2016 and Study Completion Date: January 2016. Recruitment location: University of Alabama at Birmingham.|48 subjects were screened/eligible, however the phone screen did not include consenting. 42 showed up for baseline testing and were consented, thus 42 subjects were enrolled. 42 were randomized immediately after baseline testing, however 5 were either lost to followup or deemed ineligible after baseline testing. See below for further breakdown.
722161|NCT02391116|The study was conducted at 32 centers across 10 countries, between 08 May 2015 (first patient first visit) and 18 January 2018 (last patient last visit).|A total of 91 participants were screened, of which 67 were assigned to study treatment and also started the treatment, and 24 were screened but never assigned to treatment. Altogether 27 participants were excluded from the per protocol set, which comprised 40 participants.
722162|NCT02391038|Participants took part in the study at 4 investigative sites in Korea, Japan, and Taiwan from 1 December 2014 to 7 October 2015. The study was terminated during the dose-escalation portion of phase 1 and phase 2 was not initiated.|Participants with a historical diagnosis of gastrointestinal carcinoma were enrolled in 1 of 3 treatment groups: MLN0264 1.2 milligram per kilogram (mg/kg), MLN0264 1.5 mg/kg or MLN0264 1.8 mg/kg during Phase 1.
722163|NCT02390791||
722164|NCT02390557|The unit of randomization is the practice. In each wave, we selected survey participants who were patients in those practices. For wave 2 we report the cases from Wave 1 who completed the Wave 2 survey.|
722165|NCT02390362|Only one site enrolled.|
722166|NCT02390219||A total of 46 participants were enrolled and treated in the study.
722167|NCT02390167||
722168|NCT02390076||
722169|NCT02389946||
722170|NCT02389894||
722171|NCT02389881|Participants took part in the study at 1 investigative site in the United States from 20 February 2015 to 3 December 2015.|Healthy non-elderly were enrolled in 1 of 5 treatment groups, TAK-058 25 mg, 75 mg, 150 mg, 300 mg or placebo. Healthy elderly participants were enrolled in 1 of 2 treatment groups, TAK-058 25 mg or placebo.
722172|NCT02389829||
722263|NCT02382705||
722264|NCT02382640|Participants took part in the study at 1 investigative site in United States from 23-Feb-15 to 04-May-15.|Healthy participants were enrolled in this 4 period cross over study to receive 4 regimens which included febuxostat extended release (XR) 80 milligram (mg) and Maalox suspension 20 milliliter (mL) based on different fasting conditions.
722173|NCT02389816|Participants took part in the study at 64 investigative sites in Japan, from 10 April 2015 to 16 March 2018.|Participants with a historical diagnosis of major depressive disorder were enrolled placebo lead-in period for one week prior to randomization, after that participants randomized and enrolled in one of three treatment group (Placebo Group, vortioxetine 10 milligrams (mg) Group, vortioxetine 20 mg Group) for 8 weeks as double-blind treatment period.
722174|NCT02389764|One participant was registered twice in error.|
722175|NCT02389738||
722176|NCT02389725||
722177|NCT02389712||
722178|NCT02389621|The study was conducted at 138 sites in 22 countries (Argentina, Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Poland, Republic of Korea, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, and United States of America).|"The study consisted of a screening period (up to 28 days), a treatment period of 7 days, and a posttreatment period (through 28 days posttreatment).
~Randomization was stratified by the primary invasive procedure (ie, liver ablation/coagulation or other invasive procedures) and baseline platelet count (< 35 × 10⁹/L or ≥ 35 × 10⁹/L)."
722179|NCT02389452|The study was conducted at 36 sites in India between February 16, 2010 and September 7, 2011.|
722180|NCT02389374||
722181|NCT02389361||
722182|NCT02389101||
722183|NCT02389088||
722184|NCT02388997||
722185|NCT02388932||
722186|NCT02388880||
722187|NCT02388815||A total of 89 subjects consented and were enrolled into the study.
722188|NCT02388776||
722189|NCT02388763|Participants were enrolled from 1 investigative site located in the United Kingdom.|Of the 66 enrolled participants, 2 participants were discontinued prior to randomization. This reporting group includes all randomized participants (64).
722190|NCT02388737|Participants took part in the study at 64 investigative sites in China, Malaysia, South Korea, and Taiwan from 01 April 2015 to 31 December 2018.|Participants with a diagnosis of erosive esophagitis were enrolled to receive lansoprazole 30 mg for 4 or 8 weeks (Healing Phase); or vonoprazan 10 mg, 20 mg; or lansoprazole 15 mg once daily for up to 24 weeks (Maintenance Phase).
722191|NCT02388724|Participants took part in the study at 56 investigative sites in China, Korea, Taiwan, and Malaysia from 24 March 2015 to 27 July 2017.|Participants with a diagnosis of erosive esophagitis were enrolled in a 1:1 ratio in one of two treatment groups, TAK-438 20 mg once daily (QD) or lansoprazole 30 mg QD.
722192|NCT02388568||
722193|NCT02388386||
722194|NCT02388347||A total of 79 participants were screened. Of these, 32 participants were randomized and treated in the study.
722195|NCT02388321||
722196|NCT02388295|"124 subjects were screened, 22 of these were rescreened. A total of 61 subjects were assigned a treatment allocation through randomization. Two of ineligible subjects were never dispensed investigational product.
~One ineligible randomized subject was discontinued prior to dosing and refused to supply further data."|"Protocol was administratively changed to allow reduction of sample size from 64 in this study population.
~A total of 59 completed screening and were randomized, but only 58 completed randomization and were dosed with study medication."
722197|NCT02388269||
722198|NCT02388191||
722199|NCT02388165||
722200|NCT02388074|The study was performed at Radiology Associates of Albuquerque (RAA), New Mexico during the recruitment period of March 2015 to April 20, 2015|
722201|NCT02387996|This study was conducted at 63 sites in 11 countries.|A total of 386 participants were enrolled. Of the 386 enrolled, 270 were treated. Reasons for non-treatment include 6 adverse events, 14 withdrew consent, 7 deaths, 2 poor/non-compliance, 80 no longer meet study criteria, and 7 other.
722202|NCT02387983|Adult (18 to 70 years of age) male and female participants with neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) were recruited at 4 sites in China.|
722203|NCT02387970||
722204|NCT02387957||
722205|NCT02387853||117 subjects were enrolled, this number includes all subjects who provided consent for participation in the trial and were screened. Out of the 117 subjects who were screened, 106 subjects met all inclusion criteria and none of the exclusion criteria, and were started on treatment in the LEO 90100 arm.
722206|NCT02387814||
722207|NCT02387801|Induction Dosing Period (Weeks 0 up to 12), Maintenance Dosing Period (Weeks 12 up to 48), Minimum Post Treatment Follow-Up Period up to 12 weeks after last visit.|Participants were randomized to ixekizumab (ixe) 80 mg Q2W or Q4W during the Induction Dosing Period from Week 0 to Week 12. Participants received ixe Q4W in the Maintenance Dosing Period from Week 12 to Week 48, and then to the Post Follow up Treatment Period for at least 12 weeks.
722208|NCT02387762||
722209|NCT02387749||
722210|NCT02387710||
722211|NCT02387580||
722212|NCT02387554||
722213|NCT02387502|120 patients were recruited for the study. Recruitment process started in January 2014 and the study ended in December 2014. patients were recruited in the operating rooms of a tertiary care teaching hospital.|30 patients were excluded from the study for not meeting the inclusion criteria.
722214|NCT02387476||"Eleven (11) subjects were not included in the primary analysis due to incomplete data on at least one PSG nights.
~mITT Group (subjects completing 2 nights on study with a Valid PSG result) n=36 See section 8.1 of Clinical Study Report (TR 1000-01) for details."
722215|NCT02387372|Adult males or non-pregnant or non-nursing females that were mechanically ventilated or critically ill were enrolled in this study.|
722216|NCT02387359||
722217|NCT02387268||
722218|NCT02387164||29 patients were screened for the study and 26 entered the study. Three patients were screening failures.
722219|NCT02387008||
722220|NCT02386995||
722221|NCT02386345||
722222|NCT02386189|Potential subjects, identified through VA administrative data, were recruited by mail.|
722265|NCT02382276||
722266|NCT02382133||
722453|NCT02365519|Subjects were recruited from 31 investigational sites located in the US.|Of the 514 enrolled, 213 subjects entered the vehicle run-in period and 134 entered the randomized treatment period.
723232|NCT02297841||
722223|NCT02386098|This study was planned to be conducted in two Stages (96 weeks each); but was terminated early during Stage 1 due to high rates of gastrointestinal (GI) intolerability and early end of the concurrent, 205891 (NCT02415595) formal dose-finding study. Hence, data was collected only in Stage 1 and no participants were enrolled in Stage 2.|A total of 288 participants were screened, of which 86 were randomized in a ratio of 1:1 to one of the two treatment arms in Stage 1.
722224|NCT02385799||
722225|NCT02385721||
722226|NCT02385708||
722227|NCT02385669|"Enrollment opened 4/29/15 Closed to enrollment December 2018. Enrollment has been slow due to changes in standard of care, especially the dominance of PD-1 blockade over CTLA-4 blockade.
~The study was closed to enrollment due to slow accrual, despite multiple revisions in the protocol to enhance enrollment."|
722228|NCT02385526|Subjects enrolled at 15 clinical sites including university and private hospital clinics. Enrollment was allowed following successful initiation of the first clinical site on 04MAR2015 and closed on 29JUN2016. The first subject enrolled on 28APR2015 and the final two subjects enrolled on 29JUN2016. The final subject exited the study on 10OCT2016.|"All subjects were required to receive implantation of a commercially available Vagus Nerve Stimulation generator (Stimulation of the left tenth cranial nerve via VNS Therapy) prior to randomization. The generator was to remain off until after randomization completion."
722229|NCT02385240||
722230|NCT02385084|This study was designed to have two parts. During Part A, decision was made to terminate the study. Participants in Part A were allowed to complete the study. Part B was not conducted.|
722231|NCT02384993||
722232|NCT02384941|The study was conducted at 75 study sites in 2 countries from March 2015 to February 2017.|1099 participants were screened and 793 participants with Type 1 diabetes mellitus who had inadequate glycemic control with insulin therapy were randomized into three treatment groups: Placebo, Sotagliflozin 200 mg, Sotagliflozin 400 mg.
722233|NCT02384538||A total of 132 participants were randomized; 1 participant who was randomized to the ABT-981 treatment group did not receive a dose of study drug and was excluded from the analyses, for a total of 131 participants in the modified intent-to-treat population (mITT).
722234|NCT02384460|Of 210 participants screened for this study, 169 participants were randomly assigned, on a 1:1 basis, to treatment with SD-101-6.0 or placebo at 31 study centers in 13 countries. The first participant was enrolled on 11 March 2015 and the last participant completed the study on 05 July 2017.|Participants had to be >1 month of age with a diagnosis of simplex, recessive dystrophic, or junctional non-Herlitz Epidermolysis Bullosa (EB) and a target wound with a surface area of 10 to 50 cm^2 and ≥21 days old to be considered for participation. Participants who did not meet all inclusion/exclusion criteria were eligible for rescreening.
722235|NCT02384382||
722236|NCT02384200||
722237|NCT02384096||17 subjects were enrolled in the study. 5 were withdrawn prior to randomization: 4 were withdrawn as failing to meet inclusion criteria and 1 at the subject's request prior to randomization. 12 were randomized, but 1 was randomized in error and was withdrawn same day. Statistically relevant conclusions cannot be made from this small sample size.
722238|NCT02384070||
722239|NCT02384044||
722240|NCT02383966|First participant signed informed consent: 31 Jul 2015, Clinical data cut-off: 19 Jan 2018.|
722241|NCT02383940|The study was conducted at 15 sites in United States between 20 April 2015 and 23 September 2016.|147 participants were screened and 87 participants with Type 1 diabetes mellitus who had inadequate glycemic control with insulin therapy alone, were randomized equally into two treatment groups: sotagliflozin 400 milligrams (mg) or placebo.
722242|NCT02383862|Recruitment occurred between March 2015 and April 2016 in primary care outpatient clinics.|In clinic, patients who had 1≤ SPADE (sleep, pain, anxiety, depression low energy/fatigue) symptoms, consented and provided authorization, completed PROMIS (Patient-Reported Outcome Measurement Information System), and then were randomized to a feedback or control group. Patients unable to complete enrollment prior to the encounter were excluded.
722243|NCT02383758|Participants were recruited between February 2015 and January 2017.|Of the 22 subjects consented for participation, 20 were randomized to a study intervention and were included in study analyses.
722244|NCT02383719|Comfort of mask fit for patients receiving non-invasive ventilation at Shands hospital in Gainesville Florida|
722245|NCT02383706||
722246|NCT02383667|recruitment was done in the hospital setting with patients that were admitted. start of enrollment was 3/26/2013-3/9/15.|
722247|NCT02383589||
722248|NCT02383576||
722249|NCT02383472|Recruitment began in the September of 2012 from the Concussion Clinic within the Department of Sports Medicine and lasted through the spring on 2016.|
722250|NCT02383433||
722251|NCT02383420||
722252|NCT02383355||
722253|NCT02383173|Palliative Care Consult Teams (PCCT) from eligible VA Medical Centers were recruited to participate in the education interventions. Demographic characteristics were not collected on providers.|Eligibility of VAMCs and Palliative Care Consult Team members were determined before enrollment. All those enrolled teams were randomized.
722254|NCT02383056||
722255|NCT02383043||
722256|NCT02383017||
722257|NCT02382991||
722258|NCT02382939|The trial was conducted at 26 sites in 6 countries. All 26 sites screened and randomised/ assigned patients to treatment. Denmark: 3 sites; France: 5 sites; Germany: 3 sites; Sweden: 3 sites; United Kingdom: 5 sites; Japan: 7 sites.|Participants, who were diagnosed with adults with growth hormone deficiency ≥ 6 months (defined as 180 days) prior to screening and receiving treatment with human growth hormone at least 6 months (defined as 180 days) at screening, were enrolled.
722259|NCT02382913|"Subjects were enrolled at one site in Belgium.
~- V113_01 parent study number: NCT01529645"|All enrolled subjects were included in the trial.
722260|NCT02382848||1 participant consented to the study, but decided not to continue before completing screening measures due to scheduling difficulties.
722261|NCT02382796||It is a multi-center,treatment extension study open in Japan only.Eligible participants were those with advanced non-small cell lung cancer who received and tolerated dacomitinib in studies (A7471009 [NCT01360554] and A7471050 [NCT01774721]) in Japan and had the potential to derive continued clinical benefit based on investigator judgment.
722262|NCT02382744||
722267|NCT02382016|Participants at 39 sites in 7 countries were screened and were randomized at 36 sites in these 7 countries (Brazil, Czech Republic, France, Germany, Spain, UK and US).|A total of 119 participants were screened and 85 participants were randomized (43 to macitentan 10 mg once daily and 42 to matching placebo) and received double-blind (DB) study treatment. Overall, 80 participants who completed DB treatment period entered the open-label (OL) treatment period and 33 participants in open-label extension (OLE) period.
722268|NCT02381795||
722269|NCT02381678|Investigators find total 253 patients who implanted Perimount Heart Valve during 2001 to 2007 in the Guangdong General Hospital. After the contact with these patients or their relatives, 225 patients agree to join the study.|
722270|NCT02381652|Subjects were recruited into Cingal 13-02 in February 2015. Sites that enrolled 5 or more subjects in the Cingal 13-01 study were eligible to participate in the Cingal 13-02 study. All subjects at these sites who met enrollment criteria had the option to participate in the follow-on study.|All enrolled subjects were treated with Cingal in the study. There were no exclusions.
722271|NCT02381418||
722272|NCT02381392||
722273|NCT02381288|Participants took part in the study at 1 investigative site in the United States from 10 September 2015 to 08 April 2016.|Middle-aged and older male participants with low testosterone levels were enrolled in once daily TAK-448 0.1 µg, twice weekly TAK-448 0.3 µg, once weekly TAK-448 1 µg or Placebo groups.
722274|NCT02381015||
722275|NCT02380859||There was a protocol violation in our intended randomization procedure in that participants were randomized to treatment or control groups with replacement instead of without replacement. This resulted in uneven group numbers, rather than the equal group numbers that was intended.
722276|NCT02380742||
722277|NCT02380703|2,230 persons with dementia (PWD) were contacted for telephone screening; 253 were interested and eligible for the study|239 signed written informed consent and 233 completed baseline assessments (5 were lost and 1 withdrew after signing consent); 4 were excluded at baseline due to the presence of aggression in the 3 months prior to baseline based on Cohen-Mansfield Agitation Inventory (CMAI); 1 participant withdrew prior to randomization; 228 participants were randomly assigned to a study arm (114 in each group).
722278|NCT02380690||Two participants who enrolled withdrew prior to completing baseline assessments, leaving 119 randomized to the intervention and 94 to the control group.
722279|NCT02380677||
722280|NCT02380287||
722281|NCT02380261|Participants were recruited from 1 study center located in Brazil.|Thirty-five participants were enrolled in this study. This reporting group includes all enrolled participants (35).
722282|NCT02380248|Subjects were recruited from 13 study centers in India.|Of the 207 enrolled, 6 subjects were exited as screen failures prior to treatment. In addition, 1 subject met the entry criteria, but discontinued prior to the first instillation of investigational product (IP). This reporting group includes all treated subjects (200).
722283|NCT02380183||
722284|NCT02379923||
722285|NCT02379858||
722286|NCT02379728|Participants were recruited by maternity personnel when presenting for antenatal care at the Korle Bu Teaching Hospital. Between September 2015 and March 2016, 276 women were assessed for eligibility. Seventy-six (28%) did not meet the eligibility criteria. When the target enrollment (N=200) was reached, recruitment was stopped.|
722287|NCT02379637|8 centers in canada Start date 26 Jan 2015 End date 01 Apr 2015|Screening and randomization are on day 1 Duration of the study = 7 days
722288|NCT02379585||
722289|NCT02379442||
722290|NCT02379390|Study conducted at 6 active centers in United States and Canada. A total of 8 participants were enrolled between 17 June 2015 to 13 Mar 2016. Total 15 participants were screened, out of which 7 were screen failures and 8 were randomized and treated in the study. Study was terminated early due to very low recruitment rate in both countries involved.|Participants were randomized to receive either chemotherapy (cabazitaxel) or antiandrogen receptor targeted therapy (abiraterone or enzalutamide were assigned based on previous Androgen receptor [AR] targeted treatment in which participants previously treated with abiraterone were treated with enzalutamide and vice versa due to resistance).
722291|NCT02379221||
722292|NCT02379195|All patients were recruited from Danish melanoma centers.|
722293|NCT02379117||
722294|NCT02379091|Participants took part in the study at 28 investigative sites in Bulgaria, Czech Republic, Japan, Poland, Russian Federation, Spain and the United Kingdom from 17 December 2014 to 05 December 2016.|Participants with a diagnosis of moderate to severe Rheumatoid Arthritis were enrolled equally in one of 4 treatment groups: placebo or 20, 80, 150 mg/mL namilumab.
722295|NCT02379078||
722296|NCT02379052|A total of 80 participants were screened, of whom 47 were enrolled at 14 sites. Screen failures did not meet all inclusion criteria, met one or more exclusion criterion, or withdrew consent (33 participants). Of the 47 enrolled, 23 participants were randomized to receive dupilumab 300 mg QW and 24 participants were randomized to receive placebo.|After providing informed consent, participants were assessed at screening (to occur between day -35 & day -1) for eligibility to participate in the study. Participants who met the eligibility criteria underwent day 1 baseline assessments & randomized in a 1:1 ratio to receive dupilumab or placebo during the 12-week double-blind treatment phase.
722297|NCT02378961|Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 16 February 2015. The last study visit occurred on 26 January 2016.|171 participants were screened. Enrollment was sequential, with the longer treatment duration groups enrolled, treated, and evaluated for Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) prior to enrollment of the shorter treatment duration groups, which were not enrolled, at the discretion of the Sponsor.
722298|NCT02378935|Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 17 February 2015. The last study visit occurred on 12 April 2016.|255 participants were screened. Enrollment was sequential, with the longer treatment duration groups enrolled, treated, and evaluated for Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) prior to enrollment of the shorter treatment duration groups, which were not enrolled, at the discretion of the Sponsor.
722299|NCT02378883||
722300|NCT02378844||
722301|NCT02378753||
722302|NCT02378662||
722303|NCT02378506||
722304|NCT02378480|The study was designed to enroll adult participants with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) that was known or suspected to be due to a Gram-positive pathogen(s). Randomization was stratified across treatment groups by type of infection (wound infection, cellulitis/erysipelas, and major abscess) and geographic region.|Participants who met inclusion criteria and did not meet exclusion criteria were randomly assigned to a treatment group, and received their first dose of test article within 4 hours after randomization. All participants were expected to present with ABSSSI severe enough to require a minimum of at least 3 days of intravenous treatment.
722305|NCT02378402||
722306|NCT02378220|Study was conducted at a hospital-based HHA in Searcy, Arkansas. The study population was derived from patient referrals to home health upon hospital discharge. Of 655 patients assessed for eligibility, 412 did not meet the inclusion criteria and 133 patients declined to participate.|Exclusion criteria were the same for tested and untested groups and included patients previously tested for CYP 450, history of organ transplant, current malabsorption, treatment of invasive solid tumors or hematologic malignancies in the last year, end stage renal disease or current dialysis.
722307|NCT02378207||
722308|NCT02378038|The study was initiated in August 2015 and the first subject was enrolled on 27 October 2015. Enrollment was closed as of 07 June 2016. Subjects were enrolled at oncology clinics in the USA.|
722309|NCT02378025||
722310|NCT02377986||Not applicable. Participants did not have a wash out or run-in.
722311|NCT02377947||
722312|NCT02377921||
722313|NCT02377817|"Participants were recruited from April 4 2016 through January 27 2017.
~Participants were recruited by a trained nurse a prenatal clinic at the Izaak Walton Killam (IWK) Health Centre, Halifax, Canada, which is a tertiary and primary care center for women and children."|There was no run-in measurement of baseline sleep habits. The study nights were not required to be consecutive dates. We did not specify a defined washout period. 28 participants were assessed for eligibility. Following exclusion of three who declined participation and two who failed to meet eligibility criteria, 23 were randomized.
722314|NCT02377700||
722315|NCT02377674||
722316|NCT02377466|NEWBORN-1 was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to investigate efficacy and safety of retosiban in female participants aged 12 to 45 years with an uncomplicated singleton pregnancy in preterm labor with intact membranes between 24 0/7 and 33 6/7 weeks gestation. The study was conducted in 3 countries.|Twenty-five participants were randomly assigned to study treatments: 12 participants to retosiban intravenous (IV) infusion and 13 participants to matched placebo IV infusion. Two participants randomized to retosiban arm did not receive study treatment. The study was terminated early due to feasibility of recruiting the study in a timely manner.
722317|NCT02377427|This was a multi-center, open-label study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of mepolizumab 40 or 100 milligrams (mg) subcutaneously administered to participants with severe eosinophilic asthma aged 6-11 years. This study consisted of two parts: Part A and Part B.|Part A consisted of pre-screening/ screening/ run-in, treatment, and Follow-up. Part B was long-term treatment and Follow-up phase. A total of 44 participants were screened and 36 were enrolled in Part A. Of which, 30 participants continued on treatment in Part B. Study was conducted in 4 countries (Japan, Poland, United Kingdom and United States).
722318|NCT02377362||Part A was a 3-period crossover design. Part A participants were to receive 2 escalating single doses of study drug and one dose of placebo. Part B participants were randomized to multiple doses of study drug or placebo. The study was stopped after Part B.
722319|NCT02377349|A total of 725 pregnant subjects were screened of which 690 were randomized to 2 groups. Of these, 2 subjects were withdrawn before vaccination. Therefore 688 subjects were enrolled: 1 subject was excluded from the statistical analysis, leaving 687 subjects that comprised the Total Vaccinated cohort.|Safety was assessed for infants born to vaccinated subjects as well as safety of dTap vaccination in the vaccinated pregnant subjects. There was also an assessment of the acceptance rate of a single dose of Boostrix among 723 eligible household contacts of the infants born to pregnant women enrolled in Spain, as part of an assessment of cocooning.
722320|NCT02377063|UCLA IRB-approved flyers were posted around campus. Interested subjects who respond to the approved flyers called the research site and a coordinator conducted a screening by utilizing the screening script. Eligible subjects will be scheduled for a screening visit began 5/12/2015- 7/7/2015.|
722321|NCT02376998||
722322|NCT02376933||
722323|NCT02376790|This study was conducted at 124 centers in Europe, Latin America, North America, and South Africa. Participants were enrolled from 03 March 2015 to 07 July 2017.|"The study consisted of a 30-day screening period, a 48-week randomized double blind treatment period, and a 30-day safety follow-up period.
~Participants were randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups."
722324|NCT02376530|Participants were recruited from the WNY community between 2012-2014.|
722325|NCT02376283||
722326|NCT02376257||
722327|NCT02376179||
722328|NCT02376166||
722329|NCT02375971|This study was conducted in 87 sites: Austria(2), Belgium(2), Croatia(2), Czech Republic(3), Denmark(1), Egypt(1), Estonia(1), France(2), Germany(2), Greece(3), Hungary(2), India(6), Italy(4), Japan(17), Lithuania(1), Malaysia(2), Mexico(1), Poland(2), Romania(3), Russia(5), Saudi Arabia(1), Slovakia(1), Taiwan(2), Turkey(6), UK(3) and USA(12).|One patient was discontinued prior to receiving any study treatment and was later re-randomized; this patient is counted twice in the Randomized Set (FAS) (225). The number of unique participants randomized in the study is 224.
722330|NCT02375724|"Patients were randomized in 30 study sites in 5 countries Germany (10 sites), Hungary (6), Italy (2), Spain (9) and the United Kingdom (3)
~First patient was enrolled in March 2015 and last patient last visit was in November 2015"|"300 patients were screened; 269 were assessed as eligible and were randomized into the study
~Thirty-one patients failed screening, with the main reason for screening failure being non-fulfilment of the inclusion or exclusion criteria (24 patients)"
722331|NCT02375698||
722332|NCT02375373||
722333|NCT02375347||
722334|NCT02374957||
722413|NCT02367911|"Recruitment period: January 2015 to August 2015
~The location of clinical sites included dermatology clinics and clinical research centers."|All subjects who met the entry criteria were randomized and enrolled into the study.
722597|NCT02354092||
722335|NCT02374671|The prospective, multicenter clinical trial of the VisAbility micro insert was conducted at 13 clinical sites. All recruitment evaluations were performed at the Principal Investigator's sites and subjects were screened for eligibility. If inclusion/exclusion criteria were met, informed consent was obtained and the subject was enrolled in the study.|Once determined eligible and informed consent was obtained, both eyes were enrolled in the study. Per protocol, primary outcome analysis must be performed on the primary eye only and the primary eye is therefore the unit of analysis. Fellow eyes were followed for safety outcomes and summarized separately.
722336|NCT02374593||
722337|NCT02374463|Older community dwelling veterans (age > 65 years) with evidence of balance dysfunction (Four Square Step Test > 8 seconds) and or history of falling were recruited for this study. 41 subjects signed informed consent. 10 subjects were ineligible, 4 dropped out prior to completing baseline testing resulting in 27 subjects who were randomized.|
722338|NCT02374398||
722339|NCT02374346||
722340|NCT02374307|The recruitment period was from February 2016 to February 2017. 865 older adults were assessed for eligibility. 320 had experienced a fall and received an invitation letter to participate in this study. Recruitment stopped when the sample size target (150) was expected to be reached.|167 older adults consented to baseline testing. 12 did not met the inclusion criteria and were not considered enrolled in the study. 155 met the inclusion criteria and were randomized in either the intervention or control group.
722341|NCT02374255||Oncologists were not considered enrolled into the study.
722342|NCT02374164|Healthy participants took part in the study at 1 investigative site in the United States from 2 February 2015 to 19 April 2015.|Healthy participants were enrolled equally in 1 of 3 sequences which determined the order of treatment: Regimen A (febuxostat XR 80 mg after high fat meal), B (febuxostat XR 40 mg after fasting) and C (febuxostat XR 80 mg after fasting). Regimens included a single dose on Day 1 followed by a 7-day washout period prior to receiving the next regimen.
722343|NCT02374138||
722344|NCT02374099|The study was conducted at 35 sites in Spain, Germany, Belgium, Italy and the United States.|The study enrolled adult, postmenopausal women, with metastatic breast cancer who progressed on an aromatase inhibitor. Participants were randomly assigned in a 1:1 ratio to one of two treatment arms to CC-486 tablets and fulvestrant or fulvestrant alone.
722345|NCT02374060||
722346|NCT02373865|In the time period between the start of the clinical trial (march 2015 (approval of German competent authority) and the premature termination (Jan 2017) only 4 patients of originally planned 68 patients could be recruited. Recruitment period started at 09.11.2015 when first patient was enrolled into study.|no pre-assignment details are available for this study
722347|NCT02373852||
722348|NCT02373813|This study was conducted at 97 centers in Canada, United States, Argentina, Bulgaria, Czech Republic, Spain, France, Germany, Greece, Hungary, Italy, Mexico, Poland, Portugal, and South Africa. The first participant enrolled on 20 February 2015; the last participant enrolled on 26 June 2018.|After a 24-week open label run-in period, participants were randomly assigned in a 2:2:1 ratio to one of three treatment groups: methotrexate monotherapy, etanercept monotherapy, or etanercept plus methotrexate.
722349|NCT02373371||
722350|NCT02373202|This study was conducted at 40 centers in Japan. A total of 117 participants were screened between 23 February 2015 and 9 September 2015, 26 of whom were screen failures.|A total of 91 participants were randomized to receive monotherapy stratum (in a ratio of 1:1 to sarilumab 150 mg, once in every two weeks [q2w] or sarilumab 200 mg, q2w) or combination stratum (background non-methotrexate disease modifying anti-rheumatic drugs [Non-MTX DMARDs] along with sarilumab 150/ 200 mg q2w in 1:1 ratio).
722351|NCT02373137||
722352|NCT02373124||
722353|NCT02373098||60 healthy controls and 66 Relapsing-remitting multiple sclerosis (RRMS) patients were enrolled in the study. The healthy volunteers had only Visit 1 (Day 0). Fingolimod 0.5 mg capsule once daily was given on the same day to RRMS patients. Patients were treated for 6 months with 2 additional visits, Visit 2 and Visit 3.
722354|NCT02372799||Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study
722355|NCT02372682||
722356|NCT02372396||
722357|NCT02372344|The enrollment period started 4 March 2015 and the last subject last visit was 12 May 2015. This was a 3-period crossover study with a minimum 10-day washout period between each treatment visit (Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4).|Subjects were randomized to 3 sequences (ABC, BCA or CAB; A=fasting, B=before meal, C=after meal) with a 1:1:1 ratio. 72 subjects were enrolled; 42 randomized and 30 excluded (8 did not fulfil eligibility criteria and 22 refused participation).
722358|NCT02372253||32 subjects with recent-onset Type 1 diabetes were screened for autoantibodies and MMTT-stimulated C-peptide. Five were not eligible for randomization (3 were antibody negative and 2 were C-peptide negative). One additional participant declined.
722359|NCT02372097|Participants took part in the study at 1 investigative site in Japan from 04 March 2015 to 08 April 2015.|Healthy male participants were enrolled in 1 of the 2 treatment sequences in either Period 1 or 2: Group A: 25 milligram (mg) tablet in Period 1 followed by 50 mg tablet in Period 2, Group B: 50 mg tablet in Period 1 followed by 25 mg tablet in Period 2.
722360|NCT02372071||
722361|NCT02372058||
722362|NCT02371980|Participants took part in the study at 74 investigative sites in the United States from 10 February 2015 to 25 April 2019.|Participants with diagnosis of major depressive disorder (MDD) were enrolled to receive vortioxetine 10 mg in the Open-label Period for up to 16 weeks. Responders (defined below) were randomized in 1:1:1:1 ratio to receive vortioxetine 5 mg, 10 mg or 20 mg or placebo for up to 32 weeks in the Double-blind Period.
722363|NCT02371876||
722364|NCT02371850||
722365|NCT02371785|During February - April 2015 period 20 participants were enrolled in the RAPID study at one (1) clinical site.|
722366|NCT02371759|Participants recruited between june 2013 and december 2015 among the patients of Clinic of Oral Surgery, Faculty of Dental Medicine, University of Belgrade|
722367|NCT02371746||
722368|NCT02371668||104 participants signed consent and were enrolled on the protocol. 91 participants were inoculated and randomized. 13 participants did not meet criteria for influenza challenge at Day 0.
722369|NCT02371629||A total of 1020 patients were screened for participation in this study; 776 were randomized.
722370|NCT02371616|Participants were recruited at one center (three sites) in United Kingdom.|A total of 731 participants were screened, out of which 304 participants were randomized. 427 participants were not randomized because 377 did not met the study criteria, 1 had adverse event, 3 were lost to follow up and 1 due to protocol violation, 5 withdrew consent and 40 participants were not randomized because of other reasons (not specified).
722371|NCT02371395||
722372|NCT02371369|Part 1 was a double-blind, randomized, Pexidartinib or placebo in participants with symptomatic TGCT for whom surgical resection would be associated with potentially worsening functional limitation or severe morbidity. Part 2 is a long-term treatment phase in which all eligible participants received open-label Pexidartinib.|Participants were screened for inclusion and exclusion criteria. Screening procedures were performed after consent was obtained and within the 42 days before the first dose of study drug, unless otherwise noted.
722373|NCT02371356||
722374|NCT02371187||
722375|NCT02370914||
722376|NCT02370888||Per protocol, enrollment is completion of informed consent. 11 subjects were enrolled- 2 did not meet eligibility and 9 did. Of the 9 eligible subjects- 3 received protocol treatment assignment, 5 did not have their chimerism drop, per protocol, below 90% at day 60 or 90 post-transplant, and 1 withdrew consent prior to assignment.
722377|NCT02370784|Patients were recruited at a single Scleroderma Center between March 2015 and August 2017.|
722378|NCT02370667||
722379|NCT02370641|The enrollment period was 10/31/2012 - 7/2/2013. Enrollment took place in a private setting in the clinic located at the site.|Twenty-six healthy participants were enrolled in the study. There were two study phases including a 2-week run-in period and a 4-week intervention period. Six subjects who did not complete the study were excluded.
722380|NCT02370615|Participants took part in the study at 1 investigative site in Japan from 25-February-2015 to 16-April-2015.|Healthy Japanese adult male participants were enrolled to receive TAK-272 and itraconazole in cohort 1 or TAK-272 and digoxin/midazolam in cohort 2.
722381|NCT02370602|Participants took part in the study at 1 investigative site in Sweden from 13 August 2013 to 12 March 2014.|Healthy Volunteers received 1 of 5 treatments: 11C T-773,Tak-063 3 mg, Tak-063 10 mg, Tak-063 30 mg, Tak-063 100 mg or Tak-063 1000 mg.
722382|NCT02370537|First patient enrolled: 7 April 2015. Last patient completed Part B: 17 November 2015. This study was performed in 23 centres across 6 countries in Europe.|A total of 490 patients were screened and of these, 315 patients met all inclusion and none of the exclusion criteria and completed the first part of the study. 51 patients were randomised to treatment in the second part of the study.
722383|NCT02370498|After 20 March 2016, enrollment was limited to programmed cell death ligand 1 (PD-L1) positive participants.|Of 592 participants that were randomized to trial, 570 received treatment. At the time of the primary analysis data cut-off, 89 participants are ongoing in the study.
722384|NCT02370420|The location of recruitment was the Orthopaedic and Traumatology consultation.|After the sign of the informed consent, the patients enrollment were assigned in the group of single injection or triple injection according to a randomization plan.
722385|NCT02370407||
722386|NCT02370394|We recruited perinatal women from The Center for Women's Behavioral Health (WBH) at Women and Infants Hospital (WIH) between May 2015 and April 2016.|
722387|NCT02370368||
722388|NCT02370251||
722389|NCT02370160||
722390|NCT02370121||
722391|NCT02370095||One patient was consented, randomized (Placebo) and baseline data was collected. However, before receiving treatment the subject deteriorated, and a protocol defined stopping rule was met. The subject was defined as completed. Baseline data were used in the analyses, and the AEs recorded are presented in the AE section.
722392|NCT02370056||
722393|NCT02370043|Sequence 60 mg/600 mg/Placebo subject discontinued after completion of 600 mg. Sequence Placebo/600 mg/1800 mg subject discontinued after completion of placebo.|
722394|NCT02370004||
722395|NCT02369874||
722396|NCT02369848|Study recruitment and enrollment took place at eight clinical sites in Austria, Germany and New Zealand between August 2015 and December 2015. A total of 60 subjects with calcified, stenotic peripheral arteries were enrolled and treated with the device.|
722397|NCT02369835||
722398|NCT02369796|Participants took part in the study at 1 investigative site in the United Kingdom from 10 February 2015 to 3 November 2015.|Overweight/obese male participants with a diagnosis of hypogonadotropic hypogonadism were enrolled in 1 of 5 treatment groups: once weekly TAK-448 3 µg, 1 µg or 0.3 µg or twice weekly TAK-448 0.3 µg or 0.1 µg.
722399|NCT02369744|0 Participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available|0 Participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available
722400|NCT02369510||
722401|NCT02369484|ETOP/7-14 NICHE trial was activated in December 2014. The first patient was enrolled on September 2015 while the last one on August 2016, before accrual was suspended in October 2016. Patients were enrolled in 3 centers (Netherlands Cancer Institute of Amsterdam, Vall d' Herbon Univesity Hospital (Spain) and Universitatsklinikum Koln (Germany)).|All 13 patients eligible for enrollment received treatment
722402|NCT02369341||One subject was allocated the subject number but did not receive the study vaccination.
722403|NCT02369211|Patients were recruited in the preoperative assessment clinic prior to undergoing surgery|
722404|NCT02369172|Participants took part in the study at one investigative site in United Kingdom from 03-February 2015 to 17-April 2015|
722405|NCT02369068||
722406|NCT02368886||
722407|NCT02368691|Up to 55 patients were planned for enrollment|No patients were excluded from the study before drug assignment
722408|NCT02368457||
722409|NCT02368431||Randomization was conducted by the pharmacy using a 1:1 randomization in blocks of 4 and stratified by site.
722410|NCT02368314||
722411|NCT02368210|"Recruitment period: January 2015 to June 2015
~The location of clinical sites included dermatology clinics and clinical research centers."|All subjects who met the entry criteria were randomized and enrolled into the study.
722412|NCT02368093||
723233|NCT02297815||
723234|NCT02297516||
723235|NCT02297503||
722414|NCT02367885|Participants took part in the study at 2 investigative sites in Japan from 14 February 2015 to 2 May 2015.|Healthy pediatric participants of age group 6 months-19 years were enrolled in 1 of the 3 treatment groups: TAK-850 0.25 milliliter (mL): 6 - 35 months; TAK-850 0.5 mL: 3-12 Years and TAK-850 0.5 mL: 13-19 Years.
722415|NCT02367872|Participants took part in the study at 4 investigative sites in Japan from 1 March 2015 to 10 June 2016.|Participants with normal renal (1R) and hepatic (1H) function; those who had historical diagnosis of renal (mild [2R], moderate [3R], severe or end-stage renal failure with no hemodialysis [4R], end-stage renal failure [with hemodialysis] [5R]); hepatic impairment (mild [2H] and moderate [3H]) were enrolled to receive TAK-272 40 milligram (mg).
722416|NCT02367859||
722417|NCT02367833|Participants were recruited from the Penn State University and Purdue University campuses from January 2015 to June 2016.|A total of 60 participants enrolled in the study and 34 participants did not pass the screening phase.
722418|NCT02367820|First subject screened 14 April 2015. Last subject out: 24 January 2018. The study was conducted at 55 medical/research centers in the United States.|The titration phase of the study was designed to titrate patients to a dose of NKTR-181 that provided adequate analgesia and acceptable side effects.
722419|NCT02367794||
722420|NCT02367781||Participants in this study included: histologically or cytologically confirmed, Stage IV non-squamous NSCLC; and no prior treatment for Stage IV non-squamous NSCLC.
722421|NCT02367729|Eligible subjects ages 11-18 years, recruited from the outpatient Gastroenterology clinic at the Children's Hospital of Wisconsin between September 2015 and November 2016.|Subjects were excluded if there were any changes to their current medications or any new medications added during the two weeks prior to study start. Any subject with a new diagnosis of an organic medical condition was also excluded.
722422|NCT02367716||
722423|NCT02367599|Participants in the parent trial (CCTG 595) were offered the opportunity to enroll in this sub-study providing Vitamin D supplementation to HIV pre-exposure prophylaxis (PrEP).|48 enrolled, 48 matched from parent study. Total 96 evaluated participants.
722424|NCT02367521|70 participants passed screening & were enrolled in study. 36 were not randomized.14 lost to follow-up, 5 refused due to scheduling, 5 did not meet DSM IV criteria: major depression, 3 concerns about receiving rTMS, 2 psychotropics, 2 did not have TBI, 1 using illicit drugs, 1 skull fracture, 1 severe TBI, 1 with seizure history, 1 MRI focal lesion|
722425|NCT02367430||The study did not include a wash out or run in. Not applicable.
722426|NCT02367391||
722427|NCT02367352|Participants took part in the study at 3 investigative sites in Japan and Republic of Korea from 19 March 2015 to 23 May 2017.|Participants with a diagnosis of Advanced Solid Tumors were enrolled in a dose escalation phase to receive a starting dose of alisertib 15 mg plus paclitaxel 60 mg/m^2. The dose expansion phase was not conducted.
722428|NCT02367170||
722429|NCT02367131||Non-interventional, prospective, observational, single arm based on new data collection
722430|NCT02367105|Participants were recruited through advertisements and review of medical records at the Michael E DeBakey VA Medical Center.|After obtaining written informed consent, potential participants underwent a comprehensive medical screening procedure, including an exercise stress test. If they were found eligible based on the inclusion/exclusion criteria, they were randomized into one of the two treatment groups.
722431|NCT02367066|Male or female T2DM patients of non-childbearing potential aged >=18 with 7.5<=HbA1c<=11%, 19<BMI<38 kg/m2, fasting plasma glucose in range 3-14 mmol/L and on Metformin as the only anti-diabetic treatment for the last 3 months|30 patients were enrolled in the study. 10 of these were screen failures, leaving 20 patients who started the started the study.
722432|NCT02367014|Study Centers: Akron Children's Hospital; Massachusetts General Hospital; University of Pittsburgh School of Medicine; University of California, San Diego|
722433|NCT02366936||
722434|NCT02366923||
722435|NCT02366910||
722436|NCT02366871||
722437|NCT02366845||
722438|NCT02366767|"Subjects for the Inpatients studies at Stanford were recruited from the Packard Diabetes clinics.
~Subjects for the camp studies were recruited from patients who had completed registration forms to attend camp. They were sent a letter describing the study and if they were interested they contacted us."|one subject enrolled in the closed-loop group had to leave camp after 24 hours and was replaced.
722439|NCT02366689|recruitment of subjects is done locally by the clinical site|No washout or pre-assignment phase
722440|NCT02366663||
722441|NCT02366637||Participants were randomly assigned in a 1:1 ratio to receive either PF-03715455 680 micrograms (mcg) twice daily for 4 weeks or matching placebo in Period 1. Participants who were randomized to PF-03715455 during Period 1 then received placebo for 4 weeks during Period 2 after a 28 to 49-day washout period, and vice versa.
722442|NCT02366468|a total of 135 patients were randomized and assigned in a 1:1 ratio to the treatment arms.|At Screening, the eligibility criteria were performed.
722443|NCT02366338||
722444|NCT02366195|"This study was conducted at 36 centers across 12 countries in Europe. The first participant was enrolled on 07 April 2015.
~Results are reported as of the primary analysis cut-off date of 26 June 2017, conducted once all participants had the opportunity to complete 12 months of study treatment."|
722445|NCT02366143||
722446|NCT02365961||
722447|NCT02365870||
722448|NCT02365714||
722449|NCT02365688|Patients meeting the inclusion and exclusion criteria were recruited in the pre-op clinic. Recruitment started on 15-AUG-2014 with ended in January 2015.|
722450|NCT02365636|658 patients with chronic postherpetic neuralgia (PHN) were screened; reasons for not enrolling included: inclusion criteria not met (144), exclusion criteria met (171), consent withdrawn (28), lost to follow-up (6), adverse event (1), other (8).|300 participants were randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups.
722451|NCT02365584|Recruitment to this prospective, randomised, parallel arm, open-label study began on 14 Jan 2015. Patients with a documented diagnosis of inoperable malignant bowel obstruction who had a nasogastric tube (NGT) or presented with ≥ 3 vomiting episodes/day in the last consecutive 48 hours at time of enrolment were recruited to 14 centres in Italy.|Overall, 43 patients were enrolled and treated in this phase II study. Planned study period duration was 28 days.
722452|NCT02365558||
722454|NCT02365506|Participants were enrolled at 1 study site in the United States. The first participant was screened on 20 July 2015. The last study visit occurred on 13 June 2016.|15 participants were screened.
722455|NCT02365298||
722456|NCT02365285||52 participants were screen failures and did not receive an intervention.
722457|NCT02365233||"Before randomization to obtain the intervention, eligibility criteria were verified based on an A1c test, pregnancy test and liver ultrasound to confirm fatty liver.
~IRB withheld the data due to inadequate supporting documentation."
722458|NCT02365207||
722459|NCT02364999||A total of 719 participants were enrolled in this study, and 5 of them did not receive any therapy. One (1) additional participant received only chemotherapy, and did not receive blinded bevacizumab.
722460|NCT02364947|Safety analysis set, which included all randomized patients who received ≥1 dose of the study medication.|
722461|NCT02364778||
722462|NCT02364700||
722463|NCT02364570||
722464|NCT02364388|Prospective Enrollment from 5 Sites in the Netherlands|Subjects with BI-RADS 4A or 4B by Conventional Diagnostic Ultrasound
722465|NCT02364336||Screening occurred after participant enrollment. 14 patients were enrolled. One participant failed screening, and 13 started treatment.
722466|NCT02364180|All subjects taking Pyridostigmine for at least 6months, except for the treatment of myasthenia gravis, will be considered. Subjects will be recruited from existing patients treated at the university and will be seen in the outpatient clinics.|
722467|NCT02364076||
722468|NCT02364037||
722469|NCT02363972||
722470|NCT02363959||
722471|NCT02363946||This study terminated early and no participants were enrolled in the 6.0 mg/kg and 7.0 mg/kg arms planned in Part B.
722472|NCT02363933||1 subject decided not to participate-had no more seizures after enrolling/while waiting to start
722473|NCT02363907|Subjects were recruited by one endocrinology practice in the US over a month long period, between Sep-Oct, 2012.|
722474|NCT02363803||One participant only received lidocaine infusion and did not return to receive saline infusion.
722475|NCT02363621||
722476|NCT02363478||
722477|NCT02363439||
722478|NCT02363322|Beginnning in March 2015 through November 2015 a total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea, and the United States.|
722479|NCT02363283|Recruitment period: October 2015 to January 2018|2 participants withdrew consents prior to starting therapy and 1 failed eligibility criteria.
722480|NCT02363270||
722481|NCT02362789||Of the 132 subjects enrolled in the study, 130 entered the Run-In phase.
722482|NCT02362724||
722483|NCT02362672|First subject screened: 11Mar2015; Last subject out: 28 Dec 2016. The study was conducted at 55 medical/research sites in the United States.|The titration phase of the study was designed to titrate patients to a dose of NKTR-181 that provided adequate analgesia and acceptable side effects.
722484|NCT02362646|Screening started in 2014. First patient randomized in July 2015. Last patient randomized in August 2017.|
722485|NCT02362594||As of the 02-Oct-2017 interim database cut-off date, of the 1019 randomized participants in Part 1, 544 had completed Part 1 and 62 were continuing in Part 1. This interim results disclosure is for Part 1 only.
722486|NCT02362503|This was a 2 cohort Phase 3 study conducted in heavily treatment experienced (HTE) participants infected with multi-drug resistant human immunodeficiency virus (HIV)-1. Based on the number of fully active and available antiretroviral drug classes at Screening, participants were assigned to either Randomized Cohort or Non-randomized Cohort.|A total of 731 participants were screened, of which 371 were included in either Randomized Cohort (fostemsavir or placebo) or Non-randomized Cohort (fostemsavir) and received at least one dose of study treatment. The study was conducted in 24 countries. The results presented are based on the Week 48 Interim Analysis.
722487|NCT02362425||
722488|NCT02362412|Participants with documented clinical diagnosis meeting the DSM-IV-TR criteria for bipolar I disorder or bipolar II disorder, with most recent episode depressed (296.50 to 296.54 or 296.89) confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) were recruited from 10 sites in Japan.|After informed consent was obtained and prior to randomization in Treatment Period II, participants entered Treatment Period I (4 weeks) to allow a dose titration and reduction for adjusting the dosage regimen of FK949E. Two participants did not enter Treatment Period II (due to an adverse event and withdrawal of consent, respectively).
722489|NCT02362373||
722490|NCT02362360||One subject was a screen failure and was not exposed to any of the test products. This subject was excluded from the safety population, which therefore included 52 subjects.
722491|NCT02362321||
722492|NCT02362282||Participants were screened out if presenting with unstable medical conditions that could affect safety.
722493|NCT02362269||
722494|NCT02362191||
722495|NCT02362048||
722496|NCT02361762||"Prior to randomization, 106 potential participants were screened. 31 were ineligible; 5 others declined to participate.
~70 children were randomized. 35 were assigned to training. 35 were assigned to waitlist."
722497|NCT02361736|From February 2015 to January 2016, patients were recruited and estimated for eligibility.|Exclusion criteria:Allergy and contraindication to HES; Infections and malignancies; Sepsis; History of heart failure or NYHA>Ⅲ; Renal failure or Cr>108μmol/L，BUN>8.3mmol/L;Undergoing dialytic treatments; Intracranial hemorrhages;Taking non-steroidal antiinflammatory agent for a long time
722498|NCT02361580||
722499|NCT02361476||
722500|NCT02361216|Subjects were followed for 8 weeks following the first application of investigational medicinal product (IMP) at Day 1 (3-day treatment period including an 8-week follow-up period) and for an additional 12 months following Week 8 (extended 12-month follow-up period).|
722501|NCT02360995|Subject recruitment is completed locally by the clinical site|There is no wash out or pre-assignment of any study product.
722502|NCT02360774||
722503|NCT02360631||
722504|NCT02360488||
722505|NCT02360475||
722506|NCT02360397||
722507|NCT02360319||
723236|NCT02297412||
722508|NCT02360293|Letters were mailed to potential participants. They used the information in the recruitment letter to accessed an online portal and respond to screening question. If eligible, they completed the consent documentation, baseline questionnaire, downloaded and registered the Stay Strong App. Recruitment period was from 10/1/2017 - 4/30/2018.|After consent and prior to randomization participants were to completed baseline survey, register app, and complete a baseline physical activity (PA) period for randomization. 56 participants were excluded due to failure to complete baseline survey or register app. 52 participants were excluded due to failure to provide baseline PA.
722509|NCT02360280|Recruitment from April 2015 through October 2018|Four subjects were enrolled but not assigned to treatment. They voluntarily decided to decline participation for logistical issues.
722510|NCT02360228|Participants recruited through medical providers or ads. Providers knew study criteria and discussed the study with patients during regular appointments. Interested participants contacted the study team, or were contacted by study team. Participants recruited from STEP clinic, Chapel Hill and Raleigh, and local clinics. Recruitment 4/15 to 12/16.|Participants randomly assigned to 1 of 3 arms, tDCS, tACS, or active sham. tDCS, tACS current delivered during awake, resting state for 20 minutes twice daily on 5 consecutive days. Sham stimulation was delivered for equal period of time and number of sessions. 33 participants signed consent, 7 screen fails, 1 withdrew.
722511|NCT02360215||Registered patients who completed required baseline neurocognitive assessments were randomized. Of 561 registered patients, 518 were randomized.
722512|NCT02360124||
722513|NCT02360111||
722514|NCT02360098|all patients will be seen by the anesthesiologists in the pre-anesthesia consult clinic.|Intraoperatively, all patients will have standard monitoring consisting of electrocardiography (ECG), pulse oximetry, end-tidal carbon dioxide (ETCO2), invasive and non-invasive blood pressure, temperature, urine output, depth of anesthesia (Entropy) and end tidal anesthetic agent concentration.
722515|NCT02360085||
722516|NCT02360059|Recruitment Period: October 06, 2015 to July 22, 2016. All recruitment done at The University of Texas MD Anderson Cancer Center.|Changes in breast cancer treatment and this study's requirement for a long rest-interval led to lower than expected accrual rate resulting in early study termination.
722517|NCT02359955||
722518|NCT02359916||
722519|NCT02359903||
722520|NCT02359890|This study enrolled 165 subjects at 17 clinical sites in the U.S. over approximately 5 months. The first subject was enrolled on March 30, 2015 and the last subject was enrolled on September 9, 2015. The last ablation procedure was on September 17, 2015. The last 1-month follow-up visit occurred on November 3, 2015.|
722521|NCT02359877||
722522|NCT02359851|The recruitment period for this trial was May 2015 to January 2017. The trial was conducted at Vanderbilt-Ingram Cancer Center in Nashville, Tennessee and University of Chicago in Chicago, Illinois This trial closed due to slow accrual.|
722523|NCT02359552|Patients were recruited based on physician referral from three Cleveland Clinic sites between May 2015 and January 2018|Of 96 screened participants, 50 met inclusion criteria and were enrolled and randomized to treatment.
722524|NCT02359435|"recruitment period: Oct 2012 - Mar 2015
~Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital"|None were excluded following participant enrollment.
722525|NCT02359305||
722526|NCT02359110|A total of 125 patients consented to the study, but 13 did not undergo surgery or rescheduled.|A total of 112 patients were enrolled, but 3 did not receive study drug.
722527|NCT02359058||Participants were considered completed if they either completed Cycle 1 of study drug or discontinued study drug due to a dose limiting toxicity (DLT) during Cycle 1.
722528|NCT02359045|"Participants were recruited at Baltimore, USA. All enrolled participants were included in the study.
~A total of 137 participants were enrolled (signed ICF) and underwent screening visits, out of which 55 were screen failures and 82 were independently enrolled in the study."|"All the randomized participants were divided into 2 parts. Part 1- 4 sequence for 4 periods, 4 treatments: (ADBC, BACD, CBDA, DCAB) A- D1400147, B- D14000136, C- D14000137 & D- Epanova.
~Part 2- 6 sequence for 3 treatments, 3 periods: (ABC, BCA, CAB, ACB, BAC, CBA) A-D1400147, B- D14000136 or D14000137 & C- Epanova."
722529|NCT02359019||
722530|NCT02359006|Fifty-five subjects were screened. Of those, 27 were deemed eligible and enrolled.|
722531|NCT02358889||
722532|NCT02358876||
722533|NCT02358863||
722534|NCT02358668|The study was conducted at the Diabetes and Endocrine Research Centre, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR.|77 subjects were screened and 60 subjects met the eligibility criteria to be randomized.
722535|NCT02358603||
722536|NCT02358473||
722537|NCT02358369||156 participants were enrolled and entered the washout placebo and trial-wear period. A total of 121 participants were randomized to one of three treatment groups.
722538|NCT02358343|Participants screened at 3 sites in the United States.|
722539|NCT02358135||
722540|NCT02358044||A total of 257 participants were randomized to treatment: 129 to Grazoprevir + Elbasvir arm and 128 to Sofosbuvir plus Pegylated Interferon/Ribavirin (SOF + PR) arm. Two participants in the SOF + PR arm withdrew from study prior to treatment.
722541|NCT02358031|Participants with first line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) were recruited to examine the efficacy and safety of pembrolizumab monotherapy (pembro mono) versus pembrolizumab plus chemotherapy (pembro combo) versus cetuximab plus chemotherapy (control).|Of 1228 participants screened, 882 were randomized to the pembro mono arm, pembro combo arm, or control arm. 22 participants in the control arm that enrolled during an enrollment pause of the pembro combo arm were excluded from efficacy comparisons between the pembro combo arm and control arm.
722542|NCT02357940||
722543|NCT02357901||"A total of 36 sites in the United States screened subjects in this study. Three sites did not randomize any subjects.
~Analyses of RB-US-13-0001 were planned, conducted, and reported with pooled placebo groups."
722680|NCT02347176|A total of 299 participants participated in the study at 55 sites worldwide, including 24 sites in the United States of America, 8 sites in Germany, 6 sites each in Japan, Poland, and Canada, and 5 sites in Australia.|95 participants were considered screen failures and 204 participants were randomized and treated in the study.
722544|NCT02357810|The study opened to accrual February 25, 2015 and first patient initiated treatment March 20, 2015. The study was designed to enroll up to 105 patients with soft tissue sarcoma (for at least 92 evauable), up to 36 patients with osteosarcoma and 20 patients with liposarcoma for exploratory data. The study closed to further accrual June 10, 2020.|All patients reported here signed consent, completed eligibility requirements and were registered to the study.
722545|NCT02357758||
722546|NCT02357706||
722547|NCT02357576||Patients who were enrolled were randomized shortly after enrollment. 1 patient was removed immediately after enrollment, before intervention, due to a screen fail.
722548|NCT02357485||
722549|NCT02357459|This study took place at 41 centers across the United States, Canada, Australia, New Zealand, Hong Kong, Denmark, Romania, Estonia and Lithuania. Enrollment took approximately 6 months|Subjects were screened within 21 days of being randomized.
722550|NCT02357420||A total 393 participants were randomized and received study treatment, and 334 participants completed the study. Five participants who received study drug but discontinued prematurely were summarized as completing the study because they fulfilled the Visit 8 (Week 12) assessments as per protocol.
722551|NCT02357394||
722552|NCT02357368|Participants were enrolled between February 2015 and follow up was completed on October 23, 2019. Participants were recruited from the Grady Family Planning Clinic within Grady Memorial Hospital, the Emory Clinic, and the Ponce de Leon Center of the Grady Health System, in Atlanta, Georgia.|
722553|NCT02357342||
722554|NCT02357290||
722555|NCT02357264||
722556|NCT02357173||
722557|NCT02357147|Participants took part in the study at 36 investigative sites in the United States, France, Germany, Italy, the United Kingdom, and Australia from 03 November 2015 to 30 November 2018.|A total of 124 participants were enrolled (signed informed consent form), of which, 16 were screen failures, 108 were randomized, and 106 were treated. Deaths that were primary cause of treatment discontinuation are reported in participant flow excluding those that occurred after treatment discontinuation.
722558|NCT02356900||25 participants were consented. 21 were randomized and completed the study, 1 was a screen failure, 1 withdrew after the initial biopsy and rash from bandage adhesive, 1 was withdrawn due to schedule noncompliance, and one was withdrawn after a syncopal episode during the initial biopsy.
722559|NCT02356887||
722560|NCT02356783||Forty-three patients were enrolled in study and received FitBit prior to their steroid injection appointment. Only 33 patients returned to have the steroid injection (16 interlaminar, 17 transforaminal). Three transforaminal and 1 interlaminar patient stopped using/syncing the FitBit, so data were not available to analyze.
722561|NCT02356692||
722562|NCT02356588||
722563|NCT02356575||
722564|NCT02356562|Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.|The intent-to-treat (ITT) population consisted of all enrolled participants who received at least 1 dose of study drug.
722565|NCT02356484|150 inclusions planned 155 patients screened 17 refusals study stopped after 138 inclusions due to long recruitment time|From the 155 patients initially eligible for the study, 17 refused to participate, thus 138 patients were included in the study
722566|NCT02356471||
722567|NCT02356211||
722568|NCT02356198||
722569|NCT02356107||
722570|NCT02356003||
722571|NCT02355977||
722572|NCT02355886||
722573|NCT02355743|Patients were recruited from the Children's Hospital of Pittsburgh of UPMC inpatient setting|All patients received study intervention of rtPA lock therapy which was initiated within 48 hours of a new central venous access device being placed.
722574|NCT02355691||
722575|NCT02355665||
722576|NCT02355275||
722577|NCT02355158||
722578|NCT02355067||
722579|NCT02355028|Subjects were recruited from 20 study centers located in the United States.|Of the 136 enrolled, 37 subjects were exited as screen failures and another 6 subjects were discontinued prior to randomization. This reporting group includes all randomized subjects (93).
722580|NCT02354976|This study was conducted in 4 centers in Sweden between 01 September 2015 and 26 May 2016.|The study duration was up to 15 weeks, consisting of an initial screening period lasting up to 2 weeks, a 12-week treatment period, and a follow-up telephone call within 1 week after the last dose of study drug. A total of 78 subjects were randomized.
722581|NCT02354924||
722582|NCT02354859||
722583|NCT02354833||
722584|NCT02354781||
722585|NCT02354690||One patient was enrolled in the trial and started vemurafenib, but had rapid progression of a brain metastasis and it was deemed unsafe to continue with protocol treatment. Thus, the patient was excluded before receiving T cell infusion and did not complete treatment.
722586|NCT02354599|Participant took part in the study at 1 investigative site in Japan from 25-November-2014 to 20-May-2015.|Healthy Japanese and Caucasian participants were enrolled in the study as 1 of the 4 cohorts Japanese participants in Cohort 1(MT203 80 milligram [mg]), Cohort 2 (MT203 150 mg), Cohort 3 (MT203 300 mg) and Caucasian participants in Cohort 4 (MT203 150 mg) to receive MT203, or matching placebo.
722587|NCT02354586|This was a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer participants who have received three or four previous chemotherapy regimens. The results of the study are based on primary analysis (up to 3 years).|A total of 729 participants were screened, of which 463 participants received study treatment, niraparib.
722588|NCT02354508|Planned 112 participants and analyzed 123 participants. For Participant Flow/Baseline Characteristics Tables, Total = Participants in the Pasireotide LAR arm.|Participants were allocated to Group 1 or Group 2 based on previously received first generation Somatostatin analog (SSA).
722589|NCT02354482||Any individual participant may have experienced more than one intervention.
722590|NCT02354443||
722591|NCT02354417||
722592|NCT02354378||
722593|NCT02354352||
722594|NCT02354339||
722595|NCT02354235||
722596|NCT02354222||
722598|NCT02353871|Subjects were recruited from nine active sites in France and Germany from January 2015. The study was completed in August 2015.|Overall, 190 subjects were screened, five of whom were screening failures. A total of 185 subjects were randomised to receive treatment. One of the subjects who was randomised to placebo did not receive study treatment due to violation of inclusion criterion 3.
722599|NCT02353832||
722600|NCT02353806||
722601|NCT02353780||Out of 10 enrolled subjects, 9 subjects were randomized to one of three arms. One subject withdrew consent prior to being screened/randomized.
722602|NCT02353754||
722603|NCT02353572|Between November 2009 and September 2011, 3 patients were enrolled in the study from University of Colorado Cancer Center|Within 35 days of planned therapy, patients were evaluated for eligibility by standard tests: paraprotein assessment, bone marrow biopsy and aspiration, MRI scan, PET/CT scan, echocardiography and pulmonary function test. Patients who were not be able to pursue the tandem autotransplant were eligible for one autotransplant.
722604|NCT02353468|Between December 2009 and October 2011, 3 patients were enrolled in the study from University of Colorado Cancer Center|35 days following autologous transplant, patients were evaluated for eligibility by the standard tests, including paraprotein assessment, bone marrow biopsy and aspiration, MRI scan, and PET/CT scan that is indicated for patients with hypo- or non-secretary myeloma.
722605|NCT02353442|The participation of all subjects was voluntary and no incentives were given to encourage enrollment. Fliers posted in the local university setting and surrounding community were used to recruit individuals from March 2015 to March 2016.|
722606|NCT02353299||
722607|NCT02353169||
722608|NCT02353091||
722609|NCT02352974||
722610|NCT02352948|This study was divided into 2 parts, sub-study A (82 centers across Europe, Asia, and North America) and sub-study B (149 centers across Europe, Asia, North America, and South America) conducted between 13 January 2015 and 09 February 2018 (data cut-off date).|The study had a pre-screening period to determine the programmed cell death ligand 1 (PD-L1) status, followed by a screening period and 12 month treatment period. A total of 595 participants were randomized to either sub-study A [PD-L1 high (>=25% of tumor cell (TC) expressing PD-L1)] or sub-study B [PD-L1 low/neg (<25% of TC expressing PD-L1)].
722611|NCT02352922||
722612|NCT02352844|The study opened to participant enrollment on 10/07/2015 and closed to participant enrollment on 06/28/2017.|
722613|NCT02352831|The study opened to participant enrollment on 08/31/2015 and closed to participant enrollment on 12/22/2017.|
722614|NCT02352779||
722615|NCT02352493||"A total of 62 subjects who met eligibility criteria were enrolled. Part A includes all Groups receiving a Single Ascending Dose of study drug; Part B includes all Groups receiving Multiple Ascending Doses of study drug; Part C includes the ALN-CC5 Multiple Dose - Eculizumab Treated and ALN-CC5 Multiple Dose - Eculizumab Naive Groups."
722616|NCT02352363|A total of 408 of the 513 screened were randomly assigned to CVT-301 (278) or observational cohort (130). Of these 408 patients, 398 received at least 1 dose of inhaled CVT-301 CVT-treatment group) or came in for OV1 (observational cohort) and were included in the Safety Population.|
722617|NCT02352298||52 subjects - two blood glucose assessment types each (Dario vs YSI). Totaling 104 samples of blood for with 312 data points generated across 6 Dario meters and 1 YSI assessment per subject (52 total YSI assessments).
722618|NCT02352103||
722619|NCT02351960|Participants took part in the study at 12 investigative sites in Hong Kong, South Korea, Taiwan from 19 March 2015 to 13 July 2016.|Participants with a diagnosis of non-erosive reflux disease (NERD) were enrolled to receive dexlansoprazole 30 mg and participants with erosive esophagitis (EE) were enrolled to receive dexlansoprazole 60 mg.
722620|NCT02351934|Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between February 2015 and April 2016.|
722621|NCT02351817||
722622|NCT02351739||
722623|NCT02351505||
722624|NCT02351271||
722625|NCT02351258||Data was collected at the clinic level, there was no data collected at the participant level and therefore there are no participant numbers available for any results modules.
722626|NCT02351167|The study opened to participant enrollment on 05/20/2015 and closed to participant enrollment on 07/23/2018.|-The study consented 894 participants and 72 were excluded after consenting due to no longer wanting to participate or not meeting all the eligibility criteria prior to randomization. The 72 were not considered enrolled in the study per the policy of the institution.
722627|NCT02351063||
722628|NCT02351037||
722629|NCT02350998||
722630|NCT02350881|Recruitment period : from September 2013 to April 2014|
722631|NCT02350816|The first participant enrolled in the study on 08 April 2015 and last participant last follow-up on 12 April 2019.|A total of 17 participants were enrolled and completed treatment period in the study.
722632|NCT02350777||
722633|NCT02350660||Due to changes in funding structure, the study was unable to be completed with the designed number of participants and was therefore closed to enrollment
722634|NCT02350647||
722635|NCT02350569|Participants were enrolled at study sites in the United States. The first participant was screened on 22 May 2015. The last study visit occurred on 22 April 2016.|36 participants were screened. 17 unique participants were enrolled into the study (3 received the Day -1 dose and had their transplant cancelled; 2 of these patients were re-enrolled into the Main Study; the 3rd was rescreened but not transplanted).
722636|NCT02350478||
722637|NCT02350309|Participants took part in the study at 2 investigative sites in the United Sates from 13 December 2014 to 21 April 2015.|A total of 123 participants were screened, of which 54 participants were screen failures and 69 participants were randomized to receive study treatment.
722638|NCT02350127||
722639|NCT02349789|Recruitment was conducted by the following means: Subjects were referred by local physicians and recruited from databases of previous studies of Co-investigators. Flyers were disseminated locally.|
722681|NCT02347124|Participants were recruited following registration with the Oregon (OR), Nebraska (NE), or Louisiana (LA) state quitlines. Participants were enrolled between June 2015 and July 2016.|
723237|NCT02297308|Recruitment occurred between October 7th, 2014 and February 9th, 2015 at the Montreal Heart Institute.|
722640|NCT02349711|Participants were recruited from the Gainesville, FL area, including the University of Florida campus. Recruiting began in January of 2015 and took place in facilities within the Food Science and Human Nutrition Department at the University of Florida. Participants were enrolled from 1-20-15 to 3-12-15.|Before randomization, participants provided anthropometric measurements and demographic information. Out of the 224 participants who consented to participate, only 173 remained at randomization due to the participants no longer being interested or not coming to their study visits to be randomized.
722641|NCT02349685||
722642|NCT02349646||
722643|NCT02349542||
722644|NCT02349477||The discrepancy of 6 participants is due to those subjects either violating protocol or not having evaluable data.
722645|NCT02349451||
722646|NCT02349438||A total of 25 subjects were enrolled into this study. Of the enrolled subjects 4 did not meet the eligibility criteria and 21 were dispensed study lenses. Of the dispensed subjects all 21 completed the study.
722647|NCT02349425|Participants were recruited at 12 clinical trial sites in the United States.|29 participants were enrolled, randomized and treated with study drug in Cohort 1 and 30 participants in Cohort 2. Of the 30 participants in Cohort 2, 18 of them were from Cohort 1 and they re-consented, were given new randomization numbers and treated with study drug.
722648|NCT02349412||
722649|NCT02349360||
722650|NCT02349295||
722651|NCT02349178||
722652|NCT02349152|The first subject was recruited 01-06-2016. The final subject was recruited 12-28-2016. All enrolled subjects were recruited at Presbyterian Hospital in Pittsburgh, Pennsylvania.|No pre-assignment necessary for enrollment
722653|NCT02349061||166 participants were screened during the study, 102 were enrolled/randomized and treated.
722654|NCT02349048||
722655|NCT02348918||
722656|NCT02348840|Traditional birth attendants (TBAs) were recruited from the municipality of Tecpán Chimaltenango, in rural Guatemala. Enrollment of the TBAs began in January 2015 and eligible pregnant participants were recruited from April 2016 to March 2017. All study follow up ended by February 28, 2018.|There were 64 TBAs in the study area meeting eligibility criteria who were invited to attend an informational session. Of the eligible TBAs, 49 attended the session and 44 of those individuals agreed to participate in the study.
722657|NCT02348723||Patients were randomly assigned to dabigatran etexilate 150 mg twice daily or warfarin in a 1:1 ratio and remained on this treatment for the duration of the trial. 678 subjects were randomised and 676 were treated.
722658|NCT02348684||
722659|NCT02348658|Participants took part in the study at 1 investigative site in Japan from 29 January 2015 to 11 March 2015.|Healthy adult male participants were enrolled in 1 of 2 treatment sequences in either of the Periods 1 or 2: Sequence A: TAK-536TCH (combination drug of TAK-536 [azilsartan], amlodipine besilate [AML], hydrochlorothiazide [HTZ]) Fasted in Period 1+ TAK-536TCH Fed in period 2; Sequence B: TAK-536TCH Fed in Period 1+ TAK-536TCH Fasted in Period 2.
722660|NCT02348632||A total of 645 subjects were enrolled in the study; 2 subjects withdrew from the study prior to receiving study drug. A total of 643 subjects received at least 1 dose of JZP-110 in the open-label phase and were included in the Safety Population.
722661|NCT02348619||Following screening, subjects entered the Titration phase. Subjects who were titrated to an efficacious and tolerable dose in the Titration phase remained on the same dose regimen in the Stable-Dose phase. Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
722662|NCT02348606|Note: 476 subjects were enrolled and randomized, however 2 subjects never received drug. This resulted in 474 subjects comprising the safety population.|During screening, subjects completed a medical exam. An overnight Polysomnography (PSG) assessment followed by MWT and 24-hour ABPM were conducted at baseline. After successful completion of the screening and baseline visits subjects were randomized in a 1:1:2:2:2 ratio to receive 37.5, 75, 150, or 300 mg JZP- 110 or placebo.
722663|NCT02348593||239 subjects were randomized in a 1:1:1:1 ratio to receive placebo, 75 mg JZP-110, 150 mg JZP-110 or 300 mg JZP-110. 236 subjects received at least 1 dose of study medication and comprised the Safety Population; the remaining 3 subjects were randomized in error (did not receive study medication) and were excluded from the Safety Population.
722664|NCT02348385||
722665|NCT02348359|This study was conducted at 39 sites in the United States. There were 36 sites that screened subjects and 3 sites that did not screen any subjects. A total of 157 subjects were randomly assigned and treated in the study.|
722666|NCT02348203||
722667|NCT02348008||
722668|NCT02347943||
722669|NCT02347813||Thirteen subjects consented, 1 subject screen failed, 2 subjects from the Delayed Intervention Arm were Early Terminations, 2 subjects from the Immediate Intervention Arm were Early Terminations, resulting in 4 subjects being randomized in to the Delayed Intervention Arm and 4 subjects being randomized in to the Immediate Intervention arm.
722670|NCT02347787|Study enrollment took place at: a Veterans Affairs medical center primary care practice, a federally qualified health center and an academic family medicine clinic. Patients were recruited between January 28th, 2015 and March 28, 2016 at which time the trial was stopped because we had reached our pre-specified sample size target.|
722671|NCT02347774||"All enrolled were randomized. All subjects were to be followed for the full 12-week treatment period of the study, whether or not they continued on the study drug, .until the end of the treatment period.
~One subject randomized in error to the placebo arm was never dosed ."
722672|NCT02347761||
722673|NCT02347657|The study was conducted across 91 sites in 12 countries.|A total of 510 participants were randomized and 509 participants were treated in the study.
722674|NCT02347631|Patients were screened for eligibility in 2017 at the Aston Ambulatory Optometry Clinic at UT Southwestern Medical Center.|118 patients were randomize for the study. This is a crossover to compare patients who wear DAILIES contact lenses first, then TruEye contact lenses, vs. patients who wear TruEye contacts first, them DAILIES contact lenses second.
722675|NCT02347605||
722676|NCT02347488||
722677|NCT02347345||
722678|NCT02347332||5 patients in VFL+MET arrm and 2 patients in MET arm did not receive any treatement. These patients excluded from safety population.
722679|NCT02347189||
723238|NCT02297230||
723239|NCT02297100||
722682|NCT02347098|Subject recruitment for Phase II pivotal study started on March 30, 2015, and the first participant was randomized on April 9, 2015. The recruitment period stopped in July 2017. For all 4 participating sites, Dallas, Nashville, Oklahoma City, and Denver randomized 80, 5, 38, and 6 participants, respectively.|There were 270 subjects consented and enrolled into the study before entering catheterization lab to have the PCI procedure, but 141 subjects were not randomized to treatment assignments with the major exclusion reason as not able to comply with study protocol based on the inclusion/exclusion criteria.
722683|NCT02347085|This study was conducted at 5 sites in the US from March 2015 to Jun 2015. The study was anticipated to run for approximately 6 months but not to expected to exceed 9 months.The study period was 11 to 17 weeks for each subject.|Complete crossover study to assess the efficacy and safety of GFF MDI vs. Placebo MDI. Each subject received 28 days of study treatment in each assigned treatment, with a minimum 7 day washout period between each of the 2 periods. By-treatment sequence tabulations of the data were not pre-specified.
722684|NCT02347072|This study was conducted at 10 sites in the US from February 2015 to August 2015. The study was anticipated to run for approximately 9 months but not expected to exceed 12 months.|Study to assess the efficacy and safety of GFF MDI 14.4/9.6µg relative to either Placebo MDI or Spiriva Respimat 5µg. Subjects were randomized into 1 of 6 treatment sequences, and all treatment sequences included all 3 treatments. By-treatment sequence tabulations of the data were not pre-specified.
722685|NCT02346877|This study was initiated at 15 centers in Canada, of which 8 centers enrolled participants. The first participant was enrolled on 14 April 2015 and the last participant enrolled on 13 October 2015.|Eligible participants were to be enrolled in the standard of care (control) cohort and complete the 52-week study period. Data from 75% of the group were to be analyzed before enrolling participants in the interventional cohort. As the study was prematurely closed due to slow enrollment, the interventional cohort was not enrolled.
722686|NCT02346721|Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 February 2015. The last study visit occurred on 15 June 2016.|116 participants were screened.
722687|NCT02346708|Recruitment was conducted in the United States at one site: University of Colorado Denver - Anschutz Medical Campus. The first participant was enrolled in May 19, 2014.|70 participants were assessed for eligibility (following Inclusion and exclusion criteria), 21 were screen failures, 49 participants were randomized to treatment.
722688|NCT02346643||
722689|NCT02346461||
722690|NCT02346370||A total of 16 participants were enrolled, of whom 1 participant was not treated due to disease progression prior to treatment and 15 participants received study treatment.
722691|NCT02346240|This study started to enroll participants in February 2015, from multiple sites in Europe and United States and concluded in December 2018. 559 participants are included in the Randomized Set (RS) shown in the Participant Flow.|The study included a Screening Period, an Initial Treatment Period up to Week 16, a Maintenance Treatment Period up to Week 48, an Open-Label Extension Treatment Period up to Week 144 and a Safety Follow-up Period up to Week 157. The Participants Flow refers to the Randomized Set, the Maintenance Set and the Open Label Set.
722692|NCT02346136||
722693|NCT02345889||
722694|NCT02345811||
722695|NCT02345772||
722696|NCT02345720||A total of 23 subjects were enrolled in this study. Of the enrolled subjects, 3 did not meet the eligibility criteria and 20 were dispensed a study lens. All dispensed subjects completed the study.
722697|NCT02345642||
722698|NCT02345512|Participants were recruited via the National Health service physiotherapists in 2 Health Boards.|
722699|NCT02345486|This cluster-randomized, multiple-crossover trial enrolled 974 adults admitted to a tertiary medical intensive care unit from February 3, 2015 to May 31, 2015.|
722700|NCT02345460||
722701|NCT02345369|recruitment ended when lead surgeon left the institution & types of implants used by institution were changed|
722702|NCT02345330|Participants took part in the study at 2 investigative sites in the United States from 21 May 2015 to 14 November 2016.|
722703|NCT02345252|Participants were enrolled at study sites in Europe and North America. The first participant was screened on 26 January 2015. The last study visit occurred on 09 January 2019.|690 participants were screened.
722704|NCT02345226|Participants were enrolled at study sites in Europe and North America. The first participant was screened on 26 January 2015. The last study visit occurred on 02 January 2019.|974 participants were screened.
722705|NCT02345161|This was a phase IIIa, randomized, double-blind, double-dummy, parallel group multicenter study to evaluate once daily fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI; 100 micrograms [µg]/62.5 µg/25 µg) inhalation versus twice daily budesonide/formoterol (400 µg/12 µg) in participants with chronic obstructive pulmonary disease.|A total of 2121 participants were screened in this study and 1811 were randomized following 2-week run-in. Of those, 1 participant was randomized in error and did not receive randomized treatment. This was followed by a 24-week treatment and 1-week follow-up periods. A sub-set of 430 participants continued in a blinded study treatment for 52 weeks.
722706|NCT02345070|The study was conducted at 101 active centers in 19 countries. A total of 652 participants were screened between May 2015 and May 2016, of whom, 327 participants were randomized in 1:1:1 ratio to placebo: SAR156597 200 milligram (mg) once every 2 weeks (q2w): SAR156597 200 mg once every week (qw).|Participants were stratified at the moment of randomization according to background therapy (participants with background anti-fibrotic therapy with either pirfenidone or nintedanib versus participants without background anti-fibrotic therapy).
722707|NCT02345031||
722708|NCT02344745||
722709|NCT02344628||
722710|NCT02344576|Occurred from June 2015-Jan 2017 in both the inpatient and outpatient setting. Patients were identified by the study team when a destination therapy left ventricular assist device evaluation was initiated; caregivers were identified by the medical team or patient. Recruitment and data collection were identical across control and intervention arms.|This study had a stepped-wedge design. All 6 sites started in the control phase, and then were transitioned to the intervention phase over pre-determined and randomly assigned time points (all sites ended in intervention). Participant assignment to control or intervention was determined by phase the site was in at time of participant enrollment.
722711|NCT02344407||
723240|NCT02296931||
723241|NCT02296892||
722712|NCT02344342|"Patients were randomized to one of 4 study groups:
~Telemedicine intervention_YES and Flexible Diuretic_YES Telemedicine intervention_YES and Flexible Diuretic_NO Telemedicine intervention_NO and Flexible Diuretic_YES Telemedicine intervention_NO and Flexible Diuretic_NO"|
722713|NCT02344251||
722714|NCT02344238||
722715|NCT02344225|The study started on Jan 01, 2015, and ended on Jun 30, 2018. Ninety-Eight (98) participants have been screened at five study sites. However, only 14 participants were enrolled. The reasons for poor enrollment were mostly due to refusal to participate, and some did not meet the eligibility criteria. All participants completed the study.|The study screened 98 subjects when most mothers were admitted for preterm labor. They were treated successfully with tocolysis and other clinical managements (e.g. bed rest, magnesium sulfate etc.) which resulted in prolonging the pregnancy beyond 28 weeks at which time they met exclusion criteria and no longer eligible for the study..
722716|NCT02344173||
722717|NCT02344004|This study was conducted at 127 sites in 18 countries.|"Participant flow table reflects the disposition through end of the study (Month 28).
~The deaths under Reasons for Discontinuation reflect the primary reason (according to investigator's judgment) that the participant discontinued and does not represent all deaths in the trial."
722718|NCT02343939|Participants were enrolled at study sites in United States, Canada, and Germany. The first participant was screened on 01 July 2015.|233 participants were screened.
722719|NCT02343627||
722720|NCT02343575||
722721|NCT02343458|The study was conducted at 175 sites in the United States, United Kingdom, Taiwan (TW),South Korea (SK), Russia, Poland, Hungary, Germany, Czech Republic, China, and Japan from April 2015 to August 2017. The entire study period was scheduled to take approximately 30 weeks for each individual subject from the time of screening.|Subjects were randomized in a 7:6:6:3 scheme (GFF MDI, FF MDI, GP MDI, and Placebo MDI). Randomization was stratified by reversibility to Ventolin HFA and COPD disease severity (moderate vs severe or very severe) to ensure a similar distribution of treatment arms across stratum.
722722|NCT02343406||"Intention-to-treat population (ITT): all randomized participants. Nine enrolled adult participants did not have a screen failure form reported and were not randomized. In the table below, Completed and Not completed refer to study drug treatment, and the reasons not completed listings refer to study drug treatment."
722723|NCT02343380||
722724|NCT02343276|Study was designed as a single-centre, prospective, randomised, placebo-controlled, double-blind trial with an all-comers design. All eligible patients were aged 18 years or over with a clinical indication for coronary angiography (ad hoc angioplasty was allowed) or percutaneous coronary intervention (PCI).|
722725|NCT02343263|Study closed due for administrative reasons|Study closed due for administrative reasons. Subjects fell out of study due to a number of reasons, including receiving a laser supraglottoplasty which was an exclusion criteria. Also, failure to complete study. Also our IRB later required a FDA IND which we did not obtain, so study was stopped
722726|NCT02343159||
722727|NCT02343081|This study enrolled patients with primary tumours of the Central Nervous System (CNS) excluding patients with primary CNS lymphoma, from FLENI Clinical-Surgical Diagnosis and Treatment Institute, Buenos Aires, Argentina. The last patient completed in October 2013.|Of the initial sample size of 24 patients, 19 were effectively screened during a period from October 2012 and October 2013; 3 patients did not meet inclusion criteria and 16 were randomized to the two intervention arms.
722728|NCT02343003||
722729|NCT02342886|Adult male and female patients with drug-sensitive (DS) and multi-drug resistant (MDR) smear-positive pulmonary tuberculosis (TB) were recruited into this open-label multicenter study.|Patients were confirmed sputum positive for tubercule bacilli on smear microscopy. DS-TB patients were required to be sensitive to rifampicin and newly diagnosed with pulmonary TB (or untreated for at least 3 years). MDR-TB patients were required to be resistant to rifampicin. Both DS and MDR-TB patients could be sensitive/resistant to isoniazid.
722730|NCT02342743||
722731|NCT02342704||A total of 128 participants were screened, 111 participants were enrolled in the study. Three participants were not randomized and did not receive any dose of study drug.
722732|NCT02342678||
722733|NCT02342561||
722734|NCT02342548||This was an open-label extension study conducted in participants who had completed study A8241021 (NCT02197130). Treatment assignment was double-blinded from Day 1 to Day 21, and became open-label from Day 22, since all participants began receiving the same dose level from Day 22.
722735|NCT02342535||The total number of participants who signed up for the study were 68 and not 71.
722736|NCT02342418||
722737|NCT02342379||
722738|NCT02342314||
722739|NCT02342288|Subjects were recruited in the orthopaedic clinic at West Virginia University beginning November 2008 and recruitment ended February 2014.|"Seventy-nine patients were consented and enrolled. Sixty-three were randomized. Twenty-seven patients did not complete the study. Of the 27, 16 were never randomized. The number of patients who were randomized, started the study and received full treatment or placebo was 52.
~Reasons are listed below for those who did not complete the study."
722740|NCT02342223||
722741|NCT02342197||
722742|NCT02342171||
722743|NCT02341859||Two participants enrolled in the study did not meet inclusion criteria. One participant was disqualified due to high power. All three participants therefore discontinued before lens randomization.
722744|NCT02341599|Healthy participants, participants with varying degrees of renal impairment (RI), and participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) (renal status was based on estimated glomerular filtration rate [eGFR]) were recruited at 2 study sites in the United States.|
722745|NCT02341495||
722746|NCT02341482||
722747|NCT02341456|The study was conducted at 7 clinical investigational sites located in Australia (2), Japan (2), and South Korea (3). A total of 21 subjects consented and 19 were enrolled between January 14, 2015 and June 13, 2016.|Total 21 subjects were consented to participate in the study. One (1) subject was screen failure, and one (1) other subject withdrew prior to treatment; Nineteen (19) subjects received treatment under the protocol.
722873|NCT02330978||The study requisits to enroll patients are too tight and some patients selected do not atend to all admision requisits like vision acuity worse than 20/100 in both eyes, absence of systemic comorbidities, etc.
722748|NCT02341417|This study was conducted at 16 centers in United States, Russian Federation, Ukraine, Belgium, Czech Republic, Greece, France, and Poland.|This extension study enrolled participants who completed one of the parent studies 20110100 (NCT01439867) or 20130356 (NCT02138838). Results are reported by treatment received in the parent study.
722749|NCT02341144||
722750|NCT02340975|The study was conducted in the United States of America, Japan, Korea, Taiwan and Singapore between 31Mar2015 and 29Apr2019.|A total of 114 participants were randomized in the study, out of which 113 participants received study treatment.
722751|NCT02340962||
722752|NCT02340819|The study was conducted at five centers in Japan between 18 December 2014 (first participant first visit) and 12 November 2018 (last participant last visit).|Screened participants underwent a maximum 8 week parenteral support (PS) optimization period and 4 to 8 week stabilization period (stage 1) followed by 24 weeks treatment period (stage 2), and a long-term extension period were all participants received same treatment of stage 2 in stage 3 and stage 4. Total study duration was up to 47 months.
722753|NCT02340806|220 patients met inclusion criteria.|
722754|NCT02340780||
722755|NCT02340767||The study had a pre-intervention phase, 108 clinicians (HS trained, consented, and met eligibility criterion) and 1500 patients enrolled. 85 clinicians met the enrollment threshold and were randomized.1500 patients were in the post-intervention phase.The pre- and post patients were not the same so the number analyzed for each group varies.
722756|NCT02340728||
722757|NCT02340715|420 was the initial estimate but 158 subjects was the accrual|158 subjects were enrolled.
722758|NCT02340676||
722759|NCT02340663|104 individuals screened, 81 met criteria|14 individuals dropped out prior to group assignment during consent process due to time/scheduling issues
722760|NCT02340520||Two of the 13 enrolled patients were found to be ineligible after being enrolled and therefore never started the study.
722761|NCT02340338||
722762|NCT02340299||
722763|NCT02340221||
722764|NCT02340104||
722765|NCT02340091|62 subject in total in 2 institutions period : Feb 2014~ May 2015|"spilt-face design
~Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization."
722766|NCT02340078|at 2 hospitals in korea, 62 patients. period : Nov 2013~Feb 2015|spilt-face design. Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization.
722767|NCT02340000||
722768|NCT02339909||Due to the nature of the study, informed consent could not be collected. The number of participants Started in the Participant Flow (1274) refers to the number randomised. Following randomisation, but prior to being sent the intervention letter, 223 participants became ineligible, so 1051 participants were actually enrolled in the study.
722769|NCT02339831|1153 patients electing to undergo unilateral partial or total knee replacement at the New England Baptist Hospital from 03/2007-12/2010 were screened for participation. Of these patients, 110 elected to participate in the study and were randomized into one of the two study groups.|
722770|NCT02339584|Subjects were recruited from 26 study centers located in China (14), Russia (9), and Taiwan (3).|Of the 493 enrolled, 64 subjects were exited as screen failures and another 50 discontinued prior to randomization. This reporting group includes all randomized subjects (379).
722771|NCT02339558||
722772|NCT02339545||
722773|NCT02339506||
722774|NCT02339415||
722775|NCT02339389|Following approval by our Institutional Review Board, written consent was obtained from 57 healthy, full-term women undergoing elective induction of labor who expressed interest in receiving epidural analgesia.|
722776|NCT02339285|Participants were recruited through advertisements (e.g., online, flyers) and self-identified with depression. Interested participants contacted the study team.|Participants were randomly assigned to 1 of 3 arms: tACS (alpha), tACS (gamma), or sham stimulation. All conditions were delivered during awake, resting state for 40 minutes on 5 consecutive days. 98 participants signed consent, 40 did not meet criteria, 6 declined participation, and 20 were excluded for other reasons. 32 were randomized.
722777|NCT02339246|32 patients were screened (enrolled) and 31 were randomized to treatment.|
722778|NCT02339155|This study included healthy volunteers who were not previously immunized against protective antigen. Total 873 participants were enrolled of which 214 were screen failures and 86 were not assigned. Out of 573 participants randomized 566 received study treatment and 537 completed the study.|Total 873 participants were enrolled of which 214 were screen failures and 86 were not assigned. Out of 573 participants randomized 566 received study treatment and 537 completed the study.
722779|NCT02339038||
722780|NCT02338973||People with rod-cone dystrophy (RCD) and enhanced S-cone syndrome (ESCS) were combined as pre-specified in the study protocol
722781|NCT02338882||
722782|NCT02338843||
722783|NCT02338713|Participants took part in the study at 1 investigative site in France from 16 January 2015 to 24 February 2015.|Healthy participants were enrolled in this study. Treatment period of study comprised of 2-periods. Participants received noncarbonated water in period 1 (dummy treatment period) and Calcichew D3 in period 2 (study treatment period).
722784|NCT02338492||
722785|NCT02338362|1,960 records of glaucoma patients with scheduled visits in a university-based glaucoma clinic were screened between August 1, 2014 and November 7, 2014.|22 consented to participate and 20 completed the study.
722786|NCT02338336|Recruited at a single center|"Random assignment was stratified by the size of the plantar wart:
~If the lesion size was less than 1 cm2, 3 drops were applied once weekly for 5 weeks If the lesion size was between 1 cm2 and 2 cm2, 6 drops were applied once weekly for 5 weeks If the lesion size was larger than 2 cm2, 10 drops were applied once weekly for 5 weeks"
722787|NCT02338193|Patients recruited from Woman's Hospital post delivery|3 patients not randomized since reluctant to take medication
722788|NCT02338154||516 Subjects were enrolled in this study, for which data is available.
722789|NCT02338076||
722790|NCT02337959||
722874|NCT02330627||
722791|NCT02337946|Participants took part in the study at 72 investigative sites in Japan from 16 October 2014 to 31 March 2017 (as Primary Completion Date). After that, overall study completion of this study was occurred on 31 August 2017.|Participants with a diagnosis of colorectal carcinoma were enrolled to receive protocol treatment (1) up to cycle 6 followed by randomization, received 1 out of 2 treatments from protocol treatment (2) group A and group B.
722792|NCT02337933||
722793|NCT02337907|This was a Phase II, multi-centre, double-blind, parallel-group, randomised, placebo controlled trial with patients with mild Alzheimer's disease. The randomisation allocation ratio was 1:1:1:1:2 of 10 milligram (mg), 25 mg, 50 mg once daily (QD), 25 mg twice a day (BID) of BI 409306 and placebo respectively.|All patients were screened for eligibility. All patients eligible after screening underwent a 2-week single-blind placebo run-in period before randomisation. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
722794|NCT02337764|Participants took part in the study at 25 investigative sites in Japan, from 03-Feb-2015 to 29-Sep-2016.|Participants with diagnosis of Parkinson's disease were enrolled in run- in period (Week -2 to 0). After that, the participants who fulfilled the inclusion criteria and did not meet any of the exclusion criteria at Week -2 and 0 were enrolled in the study and received TVP-1012 1 mg in an unblinded manner, from the day after Week 0.
722795|NCT02337751|Participants took part in the study at 68 investigative sites in Japan, from 10 July 2015 to 14 March 2017.|All participants with Parkinson's disease who completed the 26-week treatment period in preceding study (TVP-1012/CCT-001: NCT02337725) were enrolled in this study. Participants in TVP-1012 group and in Placebo group in preceding study were assigned to TVP-1012+TVP-1012 Group and Placebo+TVP-1012 Group in this study, respectively.
722796|NCT02337738|Participants took part in the study at 68 investigative sites in Japan, from 27-Jan-2015 to 15-Sep-2016.|Participants with diagnosis of Parkinson's disease with wearing-off phenomenon who were enrolled in run- in period (Week -2 to 0). After that, the participants who fulfilled the inclusion criteria and did not meet any of the exclusion criteria at Week -2 and Week 0 were randomized in 1:1:1 to TVP-1012 0.5 mg, TVP-1012 1 mg, or placebo at Week 0.
722797|NCT02337725|Participants took part in the study at 68 investigative sites in Japan, from 07-Feb-2015 to 15-Sep-2016.|Participants with diagnosis of Parkinson's disease were enrolled and received one tablet of placebo orally, once daily in a run-in period (Week -2 to 0). After that, the participants who fulfilled the inclusion criteria and did not meet any of the exclusion criteria at Week -2 and Week 0 were randomized in 1:1 to TVP-1012 1 mg or Placebo at Week 0.
722798|NCT02337491|Participants were enrolled between Feb 2015 and June 2016|
722799|NCT02337478||
722800|NCT02337387|This study was designed to have two parts. During Part A, one participant in each blosozumab treatment arm developed non-serious AEs, which met criteria for stopping the study. One participant was discontinued from the trial due to this AE. All other participants were discontinued due to trial termination. Part B was not conducted.|
722801|NCT02337361||Participant was assigned to control group but did not complete baseline assessment
722802|NCT02337218||
722803|NCT02337062|"Study start date:- 12th February 2015 (first patient in)
~Study completion date:- 28th September 2015 (last patient last visit)
~Location:-France, Germany and the USA."|
722804|NCT02336958||
722805|NCT02336815|Part 1 of the study was conducted at 32 sites in the United States and Part 2 of the study was conducted at 59 sites in France, Germany, Belgium, Greece, Austria and United States. Enrollment in both parts was between from 26 May 2015 (first participant first visit)) and 26 July 2019 (last participant last visit).|A total of 202 participants were enrolled in the study, out of which 79 participants were treated in Part 1 and 123 participants were treated in Part 2.
722806|NCT02336763||
722807|NCT02336737||
722808|NCT02336607|Patients enrolled in 10 centers in the People's Republic of China. First patient screened on 26th Dec. 2005, last patient completed last visit on 17th Aug. 2006. A total of 529 patients attended the screening visit. ITT population (481),PP population (390), Safety population (522).|After enrollment, 7 did not take the test medicine, 522 were given felodipine 5 mg once daily. Of these, 38 patients did not complete the 2-week felodipine monotherapy period.
722809|NCT02336594|15 subjects were randomized|Fifteen subjects were randomized to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) in a 1:1:1:1 ratio.
722810|NCT02336555|Males and females with post-herpetic neuralgia (PHN) with allodynia, at least 18 years of age (inclusive) were enrolled in this study.|
722811|NCT02336451|A total of 156 patients were enrolled and treated with ceritinib. The FAS (N=156) included all patients who received at least one dose of ceritinib with 42, 40, 12, 44 and 18 patients in arms 1 to 5 respectively. The Safety set was identical to full analysis set in this study.|Approximately 160 patients were planned to be enrolled.
722812|NCT02336438||
722813|NCT02336425||Participants were randomized to one of the four treatment arms.
722814|NCT02336373||
722815|NCT02336360|Enrollment occurred from Jan-Jun 2015 from Avid sponsored study 18F-AV-1451-A05 (NCT02016560)|
722816|NCT02336282|Between March 2015 and April 2017, 53 participants were enrolled on study to complete one session of active tDCS and one session of sham tDCS. Participants must complete both to move to the At Home tDCS phase. Twenty participants were excluded due to screening failures.|"Participants, care providers, investigator and outcomes assessor had no knowledge of group assignment.
~During campus visit, participants received tDCS and sham sessions at day1 or day2 with only order changed due to randomization. A participant was considered as a control for him/herself. For At Home tDCS phase, single arm treatment was conducted."
722817|NCT02336178|This study enrolled 70 participants.|
722818|NCT02336165||
722819|NCT02336074|Participants were recruited from 6 UK clinical sites. The recruitment period was from November 2015 until July 2017. Last patient last visit was completed in November 2017.|"Participants were recruited from two Strata:
~Recently diagnosed with primary HIV-1 infection - Eligible participants were enrolled at week 0 when combination ART (cART) began. Randomisation occurred at week 22
~Previously diagnosed with primary HIV-1 infection - Randomisation occurred within 2 weeks of screening."
722875|NCT02330588|A total of 226 participants were recruited from July to October 2015 in a pediatric primary care clinic (Figure 1; http://onlinelibrary.wiley.com/doi/10.1111/ijpo.12200/abstract).|
722876|NCT02330549||
735900|NCT01410773||
722820|NCT02335983|This study was conducted at 21 centers in the United States. The study had 2 parts: dose-evaluation and dose-expansion.|A Cohort Safety Review Committee (CSRC) reviewed all safety data and made recommendations regarding ongoing enrollment and opening of subsequent cohorts during the dose-evaluation component. The CSRC also selected the dose regimens evaluated in the dose-expansion component.
722821|NCT02335710||
722822|NCT02335658||
722823|NCT02335502||
722824|NCT02335489||
722825|NCT02335450||
722826|NCT02335424||These interim results are based on a database cutoff date of 26-September-2018, at which time 89 participants were ongoing in the study.
722827|NCT02335346|All participants were consecutive participants from F1J-JE-HMGX, NCT02248480. No new participants were enrolled.|
722828|NCT02335294||
722829|NCT02335229||
722830|NCT02335216||
722831|NCT02335125||
722832|NCT02334982|Participants took part in the study at 1 investigative site in the United States from 21 June 2013 to 30 January 2014.|Healthy Volunteers were enrolled in a 6 Cohort randomized, dose escalating study at doses of 0.5, 2,5, 10 and 20 mg TAK-137 tablets or placebo single dose once in Cohorts 5,1,2,3 and 6 fasting respectively. Cohort 4 received 5 mg tablets or placebo single dose fasting then 5 mg or placebo fed.
722833|NCT02334813||
722834|NCT02334800||A total of 28 participants were assigned to and received the study treatment (7 participants in each cohort).
722835|NCT02334787||
722836|NCT02334748||
722837|NCT02334527|12 patients were enrolled between April 2015 and January 2017.|34 patients were screened, 25 were eligible based on tumor immunohistochemistry (IHC) demonstrating p16 loss and intact retinoblastoma. Of those, 12 patients were enrolled.
722838|NCT02334436||
722839|NCT02334423||
722840|NCT02334384||
722841|NCT02334358||
722842|NCT02334306|This study was conducted across 4 countries (France, United Kingdom, Sweden, and the United States).|A total of 59 participants were screened in the study. Of which, 27 participants were screen failures and 32 participants were randomized and enrolled in study. The results are posted per the data of primary efficacy analysis last participant last visit date.
722843|NCT02334267||
722844|NCT02334215||
722845|NCT02334059||
722846|NCT02333630||
722847|NCT02333487||The study consisted of 6 to 8 patients assigned to one of 3 groups (D1, D2, or 5-HT6). Each group characterising the Lu AF35700 plasma concentration/receptor occupance (RO) relationship of 1 of 3 receptors using 1 of 3 ligands: Group D1 using [11C]-NNC 112, Group D2 using [11C]-raclopride, and Group 5-HT6 using [11C]-Lu AE60157
722848|NCT02333383||Intention-to-Treat (ITT) population: Participants who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline
722849|NCT02333331|A total of 220 patients were randomized to receive six doses of either BYM338 70 mg, BYM338 210 mg, BYM338 700 mg or the placebo. However, only 217 patients were enrolled and dosed with BYM338 or placebo due to the withdrawal of three patients who did not meet the inclusion/exclusion criteria prior to receiving the first dose.|
722850|NCT02333071|"Core (Main) Study consisted of a 4-week no drug Screening period, followed by a 4-week single blind PBO period, first dose administered in-clinic. Following the end of single-blind period, which served as Baseline, eligible subjects were then randomized to a 24-week double-blind outpatient treatment period, first dose administered in-clinic."|"Core Study: 723 participants enrolled, 70 run-in failures 653 participants were randomized.
~OLE Study (optional): Of the 464 completers of the Core study, 363 participants enrolled in optional OLE study. The OLE study was not reported and has no NCT number."
722851|NCT02333045||
722852|NCT02332915||
722853|NCT02332902||
722854|NCT02332889||
722855|NCT02332876||
722856|NCT02332863||
722857|NCT02332824|Participants took part in the study at 81 investigative sites in Japan from 16 Oct 2014 to 18 Aug 2016.|Participants with a diagnosis of type 2 diabetes mellitus and microalbuminuria (early-stage nephropathy [Stage 2] patients with type 2 diabetes mellitus) were randomized in 1:1:1:1:1:1 to either of TAK-272 5 mg, 20 mg, 40 mg, 80 mg, candesartan cilexetil 8 mg or Placebo and administered tablets orally once daily for 12 weeks in double-blind manner.
722858|NCT02332798||
722859|NCT02332720|No participants were randomized to the 'B21: GT5 NC TN MK-3682B (12 weeks)' arm.|Participants were enrolled into either Part A or Part B. Part A enrolled non-cirrhotic (NC), treatment-naïve (TN) participants with hepatitis C virus (HCV) genotype (GT) 3; Part B enrolled NC or cirrhotic (C), TN or treatment-experienced (TE) participants with HCV GT3, GT4, GT5 or GT6. Participants who relapsed in Part A were retreated in Part C.
722860|NCT02332707|This trial was conducted at 95 study sites in Asia, the European Union, and North America.|"The Number Started row reflects the number of randomized participants who received study treatment. A total of 443 participants were randomized but 1 participant withdrew consent prior to receiving any study treatment."
722861|NCT02332590|The study was conducted at 86 centers in 15 countries. A total of 540 participants were screened between 28 January 2015 and 09 July 2015, of whom 369 participants were randomized and 171 were screen failures. Screen failures were mainly due to exclusion criteria met and inclusion criteria not met.|Participants were randomized in 1:1 ratio (Adalimumab 40 mg every 2 weeks [q2w]: Sarilumab 200 mg q2w) and treated for 24 weeks. Completers are those participants who completed 24 weeks randomized treatment.
722862|NCT02332239||Of 1,190 potential screening subjects presenting to the ED for any reason during from February-December 2015, 1063 consented to screening. Of these, 1031 were successfully screened and 142 met eligibility criteria for the full trial. Of those eligible for the full randomized controlled trial (RCT), 116 consented.
722863|NCT02331992||
722864|NCT02331940||
722865|NCT02331680||
722866|NCT02331589||
722867|NCT02331446||
722868|NCT02331407|Patients with post-stroke arm paresis were recruited from June 2009 to May 2011|
722869|NCT02331394||
722870|NCT02331368|32 patients were enrolled and 3 withdrew consent prior to being treated.|
722871|NCT02331108||
722872|NCT02331095||
722888|NCT02329587||A baseline assessment was completed between participant enrollment and randomization. Withdrawal during the baseline assessment could result in enrolled participants not being assigned to a treatment group.
722889|NCT02329431|Recruitment was from a Spanish-language mental health clinic, November 2013 through August, 2015|Evaluation criteria were focal child not living with potential participant and evidence of urgent parent mental health needs
722890|NCT02329223||Participants were randomly assigned to the 3 treatment groups in a 1:1:1 ratio.
722891|NCT02329015||
722892|NCT02328937||A total of 41 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 38 subjects were dispensed a study lens. Of the dispensed subjects 2 were discontinued while 36 completed all study visits.
722893|NCT02328807|Six participants were enrolled at Moffitt Cancer Center, August 2015 through July 2017.|
722894|NCT02328547||
722895|NCT02328404|Random sample of women attending outpatient obstetrics and gynecology clinics in King Abdullah Hospital / Jordan University of Science and Technology|"Approximately 120 women will be assessed for eligibility clinically, anthropometrically, dietary and biochemically.
~Women diagnosed with PCOS and vitamin D deficiency will be randomly divided into 2 groups"
722896|NCT02328326|Participants were recruited from 11/16/16 to 5/22/18. Eligible patient participants were identified from the Ann Arbor VA Hospital or one of three affiliated Community-Based Outpatient Clinics using the VA patient database. Once identified, they received an introductory letter about the study and indicated interest by phone or mail.|None. All patient-supporter dyads who enrolled in the study were randomized to one of two study arms.
722897|NCT02328105||
722898|NCT02328040|22 participants were screened. However, only 17 participants were enrolled and of these 15 participants completed both study visits. Patients were recruited from diabetes clinics, via fliers, and online postings on clinical trial sites.|
722899|NCT02328027|It was planned that 20 evaluable patients with either RA or AS (enrolled in a 1:1 ratio) would be included and would complete the assessments on Day 56, however recruitment was terminated after inclusion of 16 patients.|Of the 16 enrolled participants, 10 participants would take part in a PK/dosimetric sub-study, after providing written approval (only 5 participants were enrolled to the sub-study). Of the first 6 enrolled participants overall, at least 3 had to take part in the sub-study to optimise the PK time points for subsequent participants .
722900|NCT02327741||
722901|NCT02327429||
722902|NCT02327325||
722903|NCT02327260|Patients were recruited for the study between March 2015 and May 2016. Patients were approached for study inclusion during hospitalization following a cardiac procedure.|
722904|NCT02327169|Participants took part in the study at 14 investigative sites in the United States, France, Spain, and United Kingdom from 14 September 2016 to 02 July 2018.|Participants with a diagnosis of advanced nonhematologic malignancies were enrolled in one of the five arm groups: MLN2480 + MLN0128, MLN2480 + Alisertib, MLN2480 + Paclitaxel, MLN2480 + Cetuximab, MLN2480 + Irinotecan.
722905|NCT02327143||This is a single arm study. Participants first received 200 mg LY2835219 and then 0.4 mg ¹³C₈-LY2835219 given 6 hours later.
722906|NCT02327130||
722907|NCT02327117||
722908|NCT02327013||
722909|NCT02326844||
722910|NCT02326649||
722911|NCT02326597|Participants were recruited between January 2015 and May 2016.|Of the 134 participants who signed consent, 120 began study participation and were included in the baseline analysis.
722912|NCT02326363||
722913|NCT02326298|The study started to enroll participants in December 2014 and concluded in October 2018 from multiple sites in Europe and North America. 234 participants were included in the Randomized Set (RS) shown in the Participant Flow.|"The study included a 5 Week Screening Period, a Double-blind Initial Treatment Period up to Week 16, a Dose-blind Maintenance Treatment Period up to Week 48, an Open-label Treatment Period up to Week 144 and a Post Study Safety Follow-up Period up to Week 152.
~Participant Flow refers to the Randomized Set, Open Label Set and Maintenance Set."
722914|NCT02326272|The study started to enroll patients in December 2014 and concluded in September 2018 from multiple sites in Europe and North America. 227 participants were included in the Randomized Set (RS) shown in the Participant Flow.|"The study included a 5 Week Screening Period, a Double-blind Initial Treatment Period up to Week 16, a Dose-blind Maintenance Treatment Period up to Week 48, an Open-label Treatment Period up to Week 144 and a Post Study Safety Follow-up Period up to Week 152.
~Participant Flow refers to the Randomized Set, Open Label Set and Maintenance Set."
722915|NCT02326233||
722916|NCT02326220|The study was conducted in Germany and the United States between 09 Mar 2015 and 20 Apr 2016. A total of 76 participants were screened, of which 62 were enrolled and randomized in the study.|Randomization was stratified according to the frequency of the apheresis procedure (every 7 or 14 days) and lipoprotein (a) (Lp [a]) levels (normal or elevated). Assignment to treatment arms was done using an Interactive Voice/Web Response System in 1:2 ratio to placebo or alirocumab 150 mg Q2W.
722917|NCT02326025||Completers include participants who died or discontinued study treatment due to progressive disease.
722918|NCT02325856||
722919|NCT02325791|The study was conducted in 2 parts between 21-Jul-2015 and 26-Sep-2017. Part A of study was conducted at 6 sites in 3 countries and Part B was conducted at 175 sites in 18 countries. Only Part B of the study was conducted in Europe. A total of 23 participants were enrolled in Part A and a total of 1,154 participants were randomized in Part B.|In Part A, 27 participants were screened, of which 23 received study drug. In Part B, out of 1,154 participants, 1,149 received first dose of study drug. Of those, 1,051 continued and received second dose 8 weeks later. Participants were randomized in 1:1:1 ratio in Part B by gestational age category & region (North America/Rest of World).
722920|NCT02325739|160 subjects were enrolled & treated with FGF401 single agent. In the Phase I part 74 subjects & 86 subjects in the Phase II part. 12 subjects were treated in the Phase I of the combination of FGF401 and PDR001. All subjects completed the study as per protocol & reasons for discontinuation of treatment are provided in the 'Not Completed' section.|At least 21 evaluable subjects were to be treated in Phase I for the model to have reasonable operating characteristics relating to its MTD &/or RP2D. Each group in the Phase II dose expansion targeted a different number of subjects. Group 1 & Group 2 planned to enroll around 40 subjects each & Group 3 planned to enroll approximately 20 subjects.
722921|NCT02325713|First/Last subject (informed consent): 21 January 2015/21 January 2015. Study completion date: 09 March 2015. The study was conducted at one center in South Africa.|Overall, 65 subjects were screened, for inclusion in this trial. Of which, 32 subjects were enrolled and randomized to a treatment sequence.
722922|NCT02325687||
722923|NCT02325518|Subjects were recruited from 26 study sites in Japan.|Of the 218 enrolled, 6 subjects withdrew informed consent and 11 were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (201).
722924|NCT02325401|Patients were 18 years or old, with newly diagnosis LAHNSCC and ECOG rating of better than or equal to 1, with adequate organ function. Individuals were excluded if they had a diagnosis of: nasopharyngeal cancer, metastatic disease, diabetes requiring insulin, or receipt of metformin with in the last 4 weeks, or history of intercurrent illness.|
722925|NCT02325219||
722926|NCT02324972||
722927|NCT02324842||
722928|NCT02324816||
722929|NCT02324699|Study opened in August 2015,and one participant enrolled almost a year later.|Study is double blind and unknown which arm participant was randomized into. Study was never unblinded.
722930|NCT02324673||
722931|NCT02324660|From December 2014 to August 2015, 169 acute cornary syndromes patients with smoking history underwent screening procedure in the University Hospital of Ferrara|
722932|NCT02324569|Participants took part in the study at 43 investigative sites in Japan, from 27 December 2014 to 28 December 2016.|Participants with a historical diagnosis of type 2 diabetes mellitus with inadequate glycemic control despite treatment with insulin therapy were enrolled in 1 of the 2 groups: Group I: 100 milligram (mg) SYR-472 in Period I followed by 100 mg SYR-472 in Period II, Group II: SYR-472 Placebo in Period I followed by 100 mg SYR-472 in Period II.
722933|NCT02324543||
722934|NCT02324504|Enrollment began in January 2016 and ended in December 2016. All subjects received the study intervention at Boston Children's Hospital (Boston, MA).|Participants (or appropriate parent/guardian) gave consent prior to placement of the peripherally inserted central catheter (PICC).
722935|NCT02324465||
722936|NCT02324361|From July to October 2014, attempts were made to solicit the participation of primary caregivers of all children receiving care since 2013 at Quincy Pediatric Associates (QPA) via mailed recruitment letters.|Caregivers were phone-screened for English fluency, internet access, computer/smartphone ownership, and ownership of a Facebook account. Those with significant functional impairments or co-morbidities, those enrolled in another weight management intervention program, or had a sibling already enrolled in the study were excluded from participation.
722937|NCT02324335||61 subjects were randomized, and 59 subjects received study drug; 59 subjects were analyzed for safety, and 46 subjects were analyzed for efficacy.
722938|NCT02324270||The populations for this study included the Safety Population, the Per-Protocol Population (PP) and the modified Intent-to-treat (mITT) population.
722939|NCT02324205||
722940|NCT02324153||
722941|NCT02324075|In this cluster trial, communities were randomized either to receive a behavior change messaging intervention or no intervention. 1226 shared latrines were analyzed within these communities. One person using the shared latrine was asked to complete study surveys (baseline and month 6), and respondents were considered to be enrolled in the study.|
722942|NCT02324049|Diagnosis of mucopolysaccharidosis III, type B (MPS IIIB), determined by either documented deficiency in Alpha-N-acetylglucosaminidase (NAGLU) enzyme activity ≤10% of the mean value in normal individuals at Screening OR documented functionally-relevant mutations in both alleles of the NAGLU gene based on historical or Screening laboratory results.|
722943|NCT02323854||
722944|NCT02323646||
722945|NCT02323204|Children between the ages of 10-17 who were hospitalized because of traumatic injury between January 2015-July 2017 along with one parent were recruited for participation at 4 children's hospitals in the Midwest.|After consenting to participation, participants completed baseline questionnaires, and were randomized to one of two interventions.
722946|NCT02323048|Healthy volunteers aged 18-35 were recruited through posters, online and newspaper advertisement, and word-of mouth referrals throughout the community.|
722947|NCT02322892|275 coronary artery bypass grafting patients screened between January and July 2015|206 patients not included for various reasons. 5 patients were randomized, but never received the assigned treatment and was therefore not included in the pre-specified modified intend-to-treat analysis.
722948|NCT02322879|After responding to the internet or print advertisement, prospective subjects were scheduled for a screening visit at the Harvard Catalyst Clinical Research Center (CRC) at BIDMC between May 2013 and August 2016. In all participants, consent was obtained prior to initiating any screening evaluation.|
722949|NCT02322866||
722950|NCT02322814|The study recruited participants with metastatic or locally advanced, triple-negative adenocarcinoma of the breast who had not received prior systemic therapy for metastatic breast cancer. Locally advanced disease must not have been amenable to resection with curative intent.|
722951|NCT02322788|Patients with stable, mild to moderate asthma were enrolled. The first subject entered study on March 10, 2015 and the last subject completed study on November 5, 2015. Subjects were recuited from Site 1001 and 1002 in Canada, Site 7201 in Sweden, and Site 5001 in Netherlands.|Of the 95 patients enrolled 34 were screen failures mainly due to not fulfilling specific randomization criteria on stability in asthma or sensitivity to methacholine challenge; 1 was withdrawal by subject; 72 entered run in period. A total of 60 patients were randomized to the 4 single-dose treatments with terbutaline in a crossover design.
722952|NCT02322775|"After enrollment, eligible patients entered a 2- to 4-week screening/run-in period and were converted to budesonide dry powder inhaler twice daily for the duration of the study.
~Patients who continued to meet eligibility criteria at the end of the run-in period entered a 12 weeks double-blind treatment period followed by two follow-up visits."|Eligible adult patients were stratified by baseline blood eosinophil count (<300 cells/μL or ≥300 cells/μL) and by region (USA versus Rest of the World per the IVRS). Patients were then randomized to either benralizumab 30 mg Q4W or placebo in a 1:1 ratio.
723143|NCT02305797|The study was conducted in 44 centers in the United States.|Patients were evaluated for eligibility during a screening period and underwent a washout from prior and concomitant medications using protocol-specified guidelines, where applicable.
737147|NCT01335308||
722953|NCT02322749|48 healthy adult males were enrolled in this single centre, randomised, open label, 3-period, 3-treatment and 6-sequence crossover study from 24 February 2015 to study completion on 30 April 2015. Subjects attended the clinical study unit for at least 1 screening visit and 3 treatment periods.|48 subjects received at least 1 of the 3 treatments and 45 completed all 3 treatment periods. There was a washout period of 7 to 10 days between administrations. A follow-up visit occurred 7 days after the last administration of the third treatment period.
722954|NCT02322710||4 patients were not randomized Presence of clinical sign suggestive of worsened wound assessed at the randomization visit (n=4)
722955|NCT02322528||
722956|NCT02322411||30 participants were consented to the study, 14 randomized to the compensatory arm, 16 to the I-PRO + compensatory arm. 1 participant in the compensatory arm withdrew after baseline residue analysis only (this participant's data is reported at baseline in the Residue Analysis Outcome Measure)
722957|NCT02322333||
722958|NCT02322320||
722959|NCT02322281|149 subjects recruited from 83 sites in 10 countries and randomized (1:1) to treatment with rociletinib or single-agent cytotoxic chemotherapy (investigator's choice of pemetrexed, gemcitabine, docetaxel, or paclitaxel). Crossover to rociletinib treatment permitted for comparator chemotherapy treated subjects but only after eligibility confirmed.|
722960|NCT02322242|Recruitment setting: pre-operative anesthesia clinic 182 recruited because of time lag between recruitment and surgery|
722961|NCT02322229|Subjects were recruited from 9 sites located in Australia and 1 site located in New Zealand.|Of the 62 enrolled, 10 subjects were exited as screen failures prior to initiation of treatment. This reporting group includes all eligible subjects (52).
722962|NCT02322216|Participants were recruited from 10 study centers located in China.|Of the 383 enrolled, 130 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (253).
722963|NCT02322190||No participants were entered in to the Second Line Therapy + Extracorporeal Photopheresis group.
722964|NCT02322047|Recruitment was done from 03/03/2015 to 09/18/2018; however the last participant was recruited on 08/30/2018 because the rest of the interested individuals were not eligible. Participants were recruited primarily through letters that were sent to those whose medical records indicated they likely had an active Alcohol Use Disorder (AUD) and had not been prescribed the study medications. Other recruitment methods: flyers, VA TV monitors, and advertising in the local media.|Interested individuals called study staff and were screened for eligibility. Out of 200 phone screens, 97 individuals were eligible and invited to the screening visit. Of these, 21 did not show or were lost to follow up, 7 canceled their visit, and 8 declined the visit. Out of 61 individuals who came to screening, 31 were eligible and randomized.
722965|NCT02321930|Patients will be recruited from the UCLA Rheumatology Clinics. The patients meeting inclusion criteria were started on tofacitinib 5mg po bid. Patients were recruited starting on 2/16/2016. The recruitment continued through 5/17/2017.|12 did not pass inclusion criteria, these patients were not able to be assigned to a study arm
722966|NCT02321800|This study was conducted at 67 hospitals in 15 countries. Participants diagnosed with complicated urinary tract infections (cUTIs) with or without pyelonephritis or acute uncomplicated pyelonephritis were enrolled from February 5, 2015 to August 16, 2016.|Participants were randomly assigned (2:1) to receive either cefiderocol or imipenem-cilastatin. Randomization was stratified by clinical diagnosis (complicated urinary tract infection with or without pyelonephritis or with acute uncomplicated pyelonephritis) and region (North America, Europe, Russia, and Japan).
722967|NCT02321748|Participants took part in the study at one investigative site in United Kingdom from 03-December 2014 to 01-April 2015|
722968|NCT02321527|Recruitment Period: July 09, 2015 to February 22, 2016. All recruitment done at The University of Texas MD Anderson Cancer Center.|
722969|NCT02321462|Adult patients due to undergo colonoscopy for a routine diagnostic indication were enrolled into this noninferiority phase 3 study at 3 study centres in Russia. First patient started: 13 March 2015; last patient completed: 28 December 2015.|305 patients were screened for inclusion, and 296 patients met all inclusion criteria and none of the exclusion criteria and were randomised to treatment. 294 patients received study treatment, and 2 patients were excluded from the safety and intention-to-treat (ITT) populations as they did not receive study treatment prior to colonoscopy.
722970|NCT02321436|A total of 42 adult subjects with upper limb (UL) spasticity were enrolled into a multicentre, prospective, double-bind, randomised, placebo-controlled pilot study, conducted in four countries (Malaysia, Thailand, Singapore, and the Philippines).|The first visit was scheduled within 2 to 12 weeks post-stroke and subjects were randomized at a ratio of 2:1 to receive either Dysport® 500 Units (U) or placebo. Dysport® was expected to have a beneficial effect in these subjects so the unbalanced randomisation ratio was chosen in order to expose the minimum number of subjects to inactive placebo.
722971|NCT02321319||
722972|NCT02321111||
722973|NCT02321098|"50 subjects included to treat their affected toenails with Loceryl NL with or without Cosmetic Varnish for 12 weeks, First Subject In (FSI) = 11 Feb 2014, Last Subject Out (LSO) = 31 Oct 2014
~29 subjects without aggravation of their disease treated their toenails with Loceryl NL 15 additional months: FSI = 03 Nov 2014, LSO = 21Jan 2016"|At screening all subjects had a mycological sampling of one of the diseased great toenails. Only screened subjects with both positive mycological results (direct microscopy and culture) at Baseline are randomized into one of the two arms for 12 weeks.
722974|NCT02320903|We completed a four-week within-subjects pre-post trial to determine the usability, acceptability, and feasibility. MST therapists in Seattle, New York City, Hartford, and Washington, DC referred families to the study. Parents contacted the study team to indicate their interest. Therapists of referred families also were enrolled in the study.|"Initial App Set Up: Clinicians were solely responsible for assisting families to set up their app; however, many clinicians were uncomfortable with this because they were not tech savvy. Solution: Phase II will include a self-guided setup tool that will empower users (parents, youth) to complete the set up independently."
722975|NCT02320838||
722976|NCT02320825||
722977|NCT02320812||
723063|NCT02313506|Our recruitment strategy identified 46 eligible individuals. Recruitment was from January 2015 to March 2015. Participants were recruited from 1) postings on Facebook, Twitter, Kajiji, Craigslist, and the Arthritis Research Canada website, 2) emails sent by the Arthritis Consumer Experts the Vancouver Coastal Health Research Institute to its staff.|
722978|NCT02320721|The study was conducted at 162 study centers across 18 countries. A total of 1515 participants were screened between 16 January 2015 and 14 October 2015, of whom 501 were screen failures.|A total of 1014 participants were randomized in 1:1 ratio to either HOE901-U300 or Lantus, stratified by screening hemoglobin A1c (HbA1c) values (<8% or ≥8%); previous use of insulin (insulin-naïve versus pre-treated); and use of sulfonylurea or meglitinides at screening ('yes' versus 'no').
722979|NCT02320695||
722980|NCT02320487||
722981|NCT02320396|Participants with seasonal allergic rhinitis (SAR) were recruited at 3 study sites in Japan.|Of 1148 participants screened, 449 were enrolled in the study and randomized to oral (PO) once daily (QD) Desloratadine (n=224) or Placebo (n=225). One participant randomized to Desloratadine was not treated due to withdrawn consent.
722982|NCT02320227||
722983|NCT02320214||
722984|NCT02320175||
722985|NCT02320149||
722986|NCT02320123||
722987|NCT02319967||
722988|NCT02319824||
722989|NCT02319759||
722990|NCT02319668|Participants were recruited from the one center in the United kingdom.|A total of 44 participants were screened, out of which 38 were randomized. 6 participants were not randomized: 2 participants did not met study criteria, 2 participants withdrew their consent, 1 participant due to protocol violation, and 1 participant due to other reason (not specified).
722991|NCT02319642|This study started to enroll subjects in November 2014 and concluded in December 2016.|Participant Flow refers to the Safety Set consisting of all subjects who were dispensed medication.
722992|NCT02319525||
722993|NCT02319486|Object: Stage II or IIIa base on International Retinoblastoma Staging System dates: January 2009- February 2014 location: Zhongshan Ophthalmic Center|"Exclusion Criteria:
~Any previous disease in the study eye.
~Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
~History of chemical intervention for retinoblastoma in the study eye.
~Over Stage I base on International Retinoblastoma Staging System for the other eye."
722994|NCT02319317||Confirmation of inclusion and exclusion criteria
722995|NCT02319174||
722996|NCT02319148||
722997|NCT02319044|127 sites in 15 countries enrolled and screened patients. The study was conducted and managed by PRA, a contract research organization.|
722998|NCT02319031|53 participants were enrolled. 50 participants were randomized and treated (24 to 12 week arm, 26 to 16 week arm). Reason for non-randomization was 3 no longer met study criteria.|
722999|NCT02319005|A total of 206 patients with hereditary amyloid transthyretin (hATTR) cardiac amyloidosis were enrolled and randomized in the study.|
723000|NCT02318992||79 were enrolled; however only 78 started--this is because one person who enrolled withdrew before treatment initiation due to insurance problem.
723001|NCT02318979||
723002|NCT02318940||
723003|NCT02318901||
723004|NCT02318797||
723005|NCT02318719|A total of 765 participants who met all inclusion and no exclusion criteria were enrolled in the study; 763 participants received treatment in the double-blind phase. A total of 239 participants received treatment in the open-label extension phase.|This study included a double-blind phase where participants received DS-5565 (15 mg, 20 mg, or 30 mg) or placebo and an open-label extension phase where participants received DS-5565 (starting dose 5 mg).
723006|NCT02318706|A total of 854 participants who met all inclusion and no exclusion criteria were enrolled; 834 were randomized to treatment in the double-blind phase. Twenty participants were excluded by the sponsor due to a serious Good Clinical Practice violation (inform consent form-related). A total of 214 participants enrolled in the open-label extension.|Participants were randomized to DS-5565 (15, 20, or 30 mg) or placebo in the double-blind (DB) phase and open-label DS-5565 in the long-term (LT) phase. Patients who complete the DB phase may not enroll in the LT phase. DB phase determine significant difference vs placebo (~750 target cases). LT phase confirm long-term safety (~180 target cases).
723007|NCT02318693|Screening for study inclusion was performed over a 4-week period. Adults with type 2 diabetes were randomized into the study.|
723008|NCT02318667||
723009|NCT02318602||
723010|NCT02318368|Subjects who met all the inclusion and none of the exclusion criteria were enrolled in 9 sites in the United States, Australia, Hong Kong, Italy, Singapore, Korea, and Taiwan. The Sponsor terminated Study AV-299-14-206, effective 14-Sep-2016, after determining that enrollment of participants was much lower than expected.|Prior to screening, subjects who have tested positive for a sensitizing Epidermal growth factor receptor (EGFR) mutation to determine eligibility for treatment with erlotinib. All participants underwent inclusion exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study-related procedures.
723011|NCT02318329||
723012|NCT02318303|Subjects were enrolled at 10 sites in the US.|
723013|NCT02318277|This study was conducted at 13 study sites in the United States. Participants were enrolled at 12 study sites.|A total of 235 participants were screened and 59 participants were screen failures. A total of 176 participants ( 34 participants in Phase 1 and 142 in Phase 2) were enrolled in the study. Study enrollment was permanently discontinued on 24 Apr 2018 as a strategic decision. At the time of data cut-off, 28 Aug 2019, 1 participant was ongoing.
723014|NCT02317809||A total of 34 subjects were randomized and treated. Of these, 31 subjects completed the study. This was a crossover study with washout of 14 to 17 days between the two intervention periods.
723015|NCT02317744||
723016|NCT02317692|Total number of participants includes children, mothers, and fathers.|1 father did not complete post-treatment measures.
723017|NCT02317614|The originally planned recruitment strategy did not work. We thus expanded our recruitment to the entire city of Baltimore instead of just one clinic.|
723018|NCT02317575|Part B was not executed and no data were collected.|Part A was a 5-period crossover study of four LY900014 formulations (Tests A, B, C, and D) and insulin lispro (Reference (R)). A minimum of 3 days washout between each period.
723064|NCT02313454||21 participants were enrolled. 1 participant had an adverse event (pre-existing condition), did not receive treatment and was withdrawn prior to controlled adverse environment (CAE) exposure.
723065|NCT02313233||
723186|NCT02301390||
723019|NCT02317549|Participants took part in the study from 6 sites in the US and Canada from 22 January 2015 to 18 March 2016 (day FDA was informed of decision to terminate the study).|The Sponsor decided to terminate this study due to slow enrollment. Throughout the study, the Sponsor made 4 protocol amendments in an effort to expand the inclusion and relax the exclusion criteria to accelerate patient enrollment. However, study was terminated after enrolling only 8 patients.
723020|NCT02317510|medical clinic|
723021|NCT02317276|For this study we recruited participants from UCSF Dermatology Clinic, and by posting advertisements online|"There was a washout period prior to screening for those patients who have previously received the following medications:
~Cyclosporine/Oral Steroids/Imuran/Mycophenolate Mofetil/Other systemic immunosuppressants: 4 weeks
~Phototherapy: 4 weeks
~Biologics: 5 half lives of the drug"
723022|NCT02317016|First patient enrolled: 10 March 2015; Last Subject Last Visit Part A: 11 July 2015 and Part B: 11 July 2016. Study performed at 14 sites across North America and Western Europe. Part A assessed effect of AZD9291 on PK of rosuvastatin following multiple oral dosing; Part B allowed subjects further access to AZD9291 and additional safety data.|
723023|NCT02316847|Adolescents or adults who have refractory epilepsy (drug resistant epilepsy per Kwan 2010) with a history of cluster seizures, also known as multiple episodes of acute repetitive seizures, for which acute treatment with a benzodiazepine was indicated as part of the standard of care or an individualized rescue treatment plan.|
723024|NCT02316769||In the King Vision arm one patient was removed from the surgery secondary to a planned procedure change and another was removed from the study because they declined to participate after already signing consent for this study. This explains the 31 patient enrollment in the King Vision arm.
723025|NCT02316717||
723026|NCT02316678|This is a retrospective cohort study of Medicaid and Medicare beneficiaries with Inflammatory Bowel Disease (IBD) in the United States using administrative data. Medicaid data were from 2001-2005 and Medicare data were from 2006-2013.|
723027|NCT02316613||Of 260 participants, 5 were excluded as no data available and duplicate cases (N=255; safety population) and 14 were excluded as other selection criteria not met (N=241; overall population).
723028|NCT02316548||Fourteen patient were screened. One patients did not continue to randomization due to disease progression and was not followed further.
723029|NCT02316470||
723030|NCT02316366||
723031|NCT02316353||
723032|NCT02316171|9 patients were enrolled into VLA012A and 6 patients into VLA012B and data presented for these 15 patients. One patient was enrolled, but not treated due to difficulties in placing the urinary catheter.|
723033|NCT02316002||
723034|NCT02315989||
723035|NCT02315872||
723036|NCT02315755||
723037|NCT02315703||
723038|NCT02315664|The recruitment period was from February 2015 - October 2016. Recruitment strategies included placing study advertisement material at Community Health Centres and Mary Pack Arthritis Centre. We also had study advertisement disseminated through Arthritis Research Canada website and group collaborators' group newsletters.|After enrollment, participants completed the baseline assessment, and after completion of baseline participants were randomly assigned to the immediate group or the delayed group (ie, control) in 1:1 allocation ratio.
723039|NCT02315625||Study closed due to poor accrual.
723040|NCT02315560||
723041|NCT02315430|The study was activated on 4/1/2015 and closed to accrual on 10/31/2016.|
723042|NCT02315352||This was a swill and spit taste study where the drug was not swallowed but spit out after tasting. Gustatory sensation tests were performed on the different formulations immediately after tasting and 2-5 min after the study drug has been spat out.
723043|NCT02315261||
723044|NCT02314936||
723045|NCT02314923||
723046|NCT02314689||
723047|NCT02314637||
723048|NCT02314598||
723049|NCT02314546||
723050|NCT02314520||
723051|NCT02314260|started July 2014 till December 2014 & recruited 80 primigravidas undergoing scheduled for pregnancy termination at Kasr El Aini Hospital|
723052|NCT02314247||
723053|NCT02314143|This is an open label, randomized, phase II study to compare the combination of dabrafenib with trametinib versus the combination after eight weeks of monotherapy with dabrafenib or trametinib in metastatic and unresectable stage III or IV melanoma. The study was terminated early due to slow enrollment and limited numbers of viable tissue samples.|This study was planned to enroll 54 participants randomized in 1:1:1 ratio into the three treatment arms; dabrafenib followed by combination therapy, trametinib followed by combination therapy and only combination therapy. The study was early terminated with 48 participants enrolled.
723054|NCT02314117||Completers are defined as participants who died or those who were alive and off treatment when the study completed.
723055|NCT02314104||
723056|NCT02314052||
723057|NCT02314026||
723058|NCT02314000|Enrolled subjects underwent study eligibility to determine if they can continue in the study. Following completion of study eligibility, subjects were randomized to the cross-over phase.|
723059|NCT02313909|Study was conducted at multiple centers in 31 countries between 23 December 2014 (first participant first visit) and 15 February 2018 (last participant last visit).|Overall, 7582 participants were screened; of these 369 participants were screen failures. A total of 7213 participants were randomized, of which 92 never took study drug; 3562 were treated with rivaroxaban(Xarelto, BAY59-7939) /placebo and 3559 were treated with acetylsalicylic acid/placebo.
723060|NCT02313766|Planned Recruitment period : from october 01,2006 to october 31,2007 The day of surgery, the patient was randomly allocated (random number table, equilibration block sizes of 15)|patients received oral information and signed a written informed consent at the end of the preanaesthesia medical consultation
723061|NCT02313675||
723062|NCT02313558|The recruitment began in March,2013,at West China College of Stomatology Chengdu, Sichuan, China.|In the experimental group, 2 patients withdrew immediately after randomization; the withdrawal was not the result of the dentifrices used.
723140|NCT02306265|The subject population consisted of asymptomatic adult women (30 years of age or greater) scheduled for routine screening mammography.|
723141|NCT02305888||
723187|NCT02301377||
723066|NCT02313155|Participants took part in the study at 1 investigative site in Japan from 13-December-2014 to 22-January-2015.|Healthy adult participants were randomized to receive a single dose of 0.5 milliliter (mL) of TAK-850 in 1 of the 2 treatment groups: TAK-850 subcutaneous injection and TAK-850 intramuscular injection.
723067|NCT02312934|Participants were recruited through Vanderbilt University-affiliated clinics and the greater Nashville, TN community.|Of the 106 people pre-screened for the study, 37 attended the initial screening visit. Twenty-two participants met entry criteria and were randomized. Participants that were not randomized were excluded from the study because they did not meet inclusion/exclusion criteria.
723068|NCT02312882||
723069|NCT02312856||
723070|NCT02312765||
723071|NCT02312739||
723072|NCT02312726||
723073|NCT02312713||
723074|NCT02312687||
723075|NCT02312622||
723076|NCT02312310|"first consent; 1/13/2016 Final data collection session: 11/21/2018
~All data collected at Columbia University Medical Center"|"consent: exclusions: 5 BMI too high; 66 MOCA too low; 4 elevated blood pressure; 16 other; 17 lost to follow-up
~two week run-in period: exclusions: 24 failed, 17 withdrew or lost to follow-up
~baseline assessments: exclusions: 1 lost to follow-up"
723077|NCT02312258|Participants took part in the study at 187 investigative sites worldwide from 09 April 2015 to data cut-off: 12 Aug 2019. This study is ongoing.|Participants with newly diagnosed multiple myeloma not treated with stem cell transplantation (SCT) were enrolled and randomized in 3:2 ratio to receive ixazomib or placebo respectively.
723078|NCT02312219||
723079|NCT02312206||
723080|NCT02312154||
723081|NCT02312063||
723082|NCT02311972|Of 52 enrolled infants, 20 infants were randomized. Of those not randomized, 18 were over/underweight, 8 mothers were discharged prior to delivery/lost to contact, 5 infants were not enrolled due to no page at infant delivery and 1 was not enrolled because the infant did not a require feeding tube per attending physician at delivery.|
723083|NCT02311907|Total of 195 patients were enrolled, 185 started the treatment (8 cancels, 1 ineligible and 1 excluded due to switching regimens).|
723084|NCT02311894||
723085|NCT02311881|This study was conducted in 57 centers in United States.|A total of 1531 participants were screened for study. Out of which only 960 participants who completed screening visit & took part in wash-out period were enrolled. Out of 960 enrolled participants, only 708 were randomized. 252 were not randomized because they did not fulfill specific inclusion criterion measured at the end of the wash-out period.
723086|NCT02311478||
723087|NCT02311361||
723088|NCT02311309||
723089|NCT02311153|Recruitment was completed in clinic and the pre-operative surgical area.|"2 patients were consented and enrolled in the clinic setting, but they did not end up being randomized:
~1 did not proceed with surgery
~1 was diagnosed with sleep apnea, which is exclusionary"
723090|NCT02310906|The study was conducted at 5 sites in the France, Italy, United Kingdom and United States from 13 January 2015 to 25 March 2019.|Study conducted in 2 parts: Part 1 and Part 2. When Part 1 was completed and cumulative safety data was reviewed by an independent Data Safety Monitoring Board (DSMB), Part 2 was conducted.
723091|NCT02310789||
723092|NCT02310776||
723093|NCT02310763||A total of 162 participants were screened, 121 participants were enrolled in the study and assigned to 1 of 3 sequences. Only 120 participants received the study treatment and 1 participant withdrew prior to dosing.
723094|NCT02310750||Study conducted in 7 Healthy Participant (HP) cohorts: 6 cohorts included Single Ascending Dose (SAD), 4 which continued into Multiple Ascending Dose (MAD) with washout, and a final cohort was tested for food effect (fasted/fed) with washout. 1 multiple dose (MD) cohort in Psoriasis subjects received drug at 2 different dose levels or placebo.
723095|NCT02310672||Total 112 participants were screened out of them 89 participants were enrolled in the study and of which 87 participants received study medication. Two participants who did not receive study treatment were wrongly classified as enrolled by the sites.
723096|NCT02310646|219 subjects from Canada (8 sites) and Germany (7 sites) were enrolled into the trial. First Subject First Visit:10-Feb-2015 and Last Subject Last Visit: 03-Aug-2015 (last visit, including follow-up). 6 enrolled subjects were not randomised.|Screening assessments were performed at the Screening Visit which could occur up to 28 days prior to Baseline (Day 1; Visit 1). A washout period of up to 4 weeks was to be completed if the subject was treated or had recently been treated with anti-psoriatic treatments or other relevant medication, as defined by the exclusion criteria.
723097|NCT02310581||
723098|NCT02310568||This was a sequential parallel study consisting of 2 stages: 4 week randomized treatment period (Stage 1) followed by a 4 week treatment period (Stage 2). Participants randomized to placebo for Stage 1, received either PF-06372865 or placebo in Stage 2 and participants randomized to PF-06372865 in Stage 1 were assigned to Placebo in Stage 2.
723099|NCT02310126||This study enrolled a total of 195 subjects. Of those enrolled, 4 subjects did not meet the eligibility criteria, and 191 subjects were dispensed study lenses. Of those dispensed, subjects 189 completed the study and 2 subjects were discontinued. Subjects were stratified as either Hyperops or Myopes based on their sphere power.
723100|NCT02310100|"109 subjects were directly enrolled into the TactiCath PAS 50 subjects rolled over from the TactiCath Continued Access Protocol 19 subjects rolled over from the TOCCASTAR Supplemental Study The first subject was enrolled on January 21, 2015 and the last subject on January 29, 2016.
~All enrollment was from sites within the United States."|Only subjects that met all inclusion criteria and did not meet any exclusion criteria were enrolled in the study.
723101|NCT02309944||93 participants originally consented, one withdrew consent and 11 did not return updated HIPAA forms and therefore could not be included in the analysis
723102|NCT02309723||
723103|NCT02309489||
723142|NCT02305849|Participants with rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX) were enrolled in this study.|Participants were randomized in a 1:1:1 ratio to peficitinib 100 milligram (mg), 150 mg or placebo groups in combination with MTX at baseline. At week 12 or 28, participants in the placebo group were switched to receive either peficitinib at a dose of 100 mg or 150 mg, which was determined in advance randomly.
731481|NCT01695330|Patients with MM who received treatment with a SC bortezomib-containing combination|
723104|NCT02309411|Study was conducted at 27 study centers in 14 countries: Australia, Austria, Brazil, Canada, Hungary, Israel, Italy, Japan, Netherlands, Russia, Spain, Switzerland, United Kingdom, and United States between 15 January 2015 (first subject first visit) and 05 April 2017 (last subject last visit).|Overall, 51 subjects were screened, of these 5 subjects were screen failures; 4 subjects withdrew from study and 1 subject failed screening. Total of 46 subjects were assigned to treatment with 6 subjects received anticoagulant comparator (standard of care) and 40 subjects received rivaroxaban.
723105|NCT02309372||
723106|NCT02309359|A total of 345 subjects were recruited at 63 sites located in Europe (46 sites; 259 subjects), Latin America (7 sites; 59 subjects) and North America (10 sites; 27 subjects). Consent was obtained from the first subject on 30 Jan 2015; the last subject completed the final visit on 8 Aug 2016.|Of the 712 subjects screened, 367 were screen failures and 345 were randomly assigned to treatment (Intent-to-treat population). All subjects enrolled received study drug and were included in the safety population. All subjects who received at least one dose of ALX-0061 (i.e., 276 subjects) were included in the pharmacokinetic (PK) population.
723107|NCT02309294||
723108|NCT02309138|Pregnant women were recruited from June 2015 to February 2019 from 10 obstetrical clinics affiliated with Magee Women's Hospital in Pittsburgh,Pennsylvania|
723109|NCT02309112|Recruitment in Vancouver, Canada commenced on April 15, 2014 via poster advertisements in Vancouver cancer clinics (n=3).|"No wash out or run-in period was allocated.
~Recruitment ended on June 30, 2014 and participants were randomized on July 1, 2014."
723110|NCT02309099|Recruitment was completed in medical clinic by surgeon if a patient is identified as a potential participant and has decided to undergo vestibular schwannoma resection via a translabyrinthine surgical approach or a labyrinthectomy for Meniere's disease.|Groups were based on the participants' diagnosis (vestibular schwannoma or Meniere's disease) and subsequent surgery. Participants were initially consented into their specific group.
723111|NCT02308839||
723112|NCT02308787||
723113|NCT02308748||44 healthy volunteers were assessed for eligibility. 15 subjects were excluded because they did not meet the inclusion criteria. 22 of 29 subjects who met the inclusion criteria were randomized and allocated to receive crossed-over intervention. Williams Latin square design balanced for first-order carryover effects was used for randomization.
723114|NCT02308696||
723115|NCT02308540||Adult cohort: 43 screened and 9 screen failures Toddler cohort: 173 screened and 61 screen failures Infant cohort: 262 screened and 62 screen failures
723116|NCT02308475||
723117|NCT02308371|Prospective subjects were considered for enrollment if less than 17 years of age and admitted to the pediatric critical care unit. In addition subjects had to require conventional mechanical ventilation and have an arterial line. Prospective recruitment time between 11/26/2014 and 3/1/2016.|Prospective subjects per the protocol were allowed more than one enrollment on the study during the same admission once recruited. There were 46 unique prospective subjects with 50 enrollments and 50 retrospective enrollments. Numbers below and throughout the results section represent number of enrollments or participation.
723118|NCT02308228|Number of individuals consented and further screened for eligibility = 144 Number of participants randomized to drug/placebo = 109 Number of participants completing exercise intervention with drug/placebo use = 94|"Participants may have been excluded prior to randomization to study drug for the following reasons:
~Screen fail (OGTT, ECG, Blood results)
~Withdrawals (changed mind, lost to follow up, spouse screen fail)"
723119|NCT02308189||
723120|NCT02308163|Participants with rheumatoid arthritis (RA) who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were enrolled in 142 sites in Japan, 11 sites in Korea and 12 sites in Taiwan.|Participants were randomized in a 1:1:1:2 ratio to peficitinib 100 mg, 150 mg, placebo or etanercept groups at baseline. At week 12, participants in the placebo group were switched to receive either peficitinib at a dose of 100 mg or 150 mg. The dose of peficitinib administered to the placebo group from week 12 was determined in advance randomly.
723121|NCT02308124||
723122|NCT02308046||
723123|NCT02308033||
723124|NCT02308020||Completers include participants who died or discontinued study treatment due to progressive disease and is in follow up.
723125|NCT02308007||
723126|NCT02307916||"Patients who met exclusion criteria were considered screen-fail and were not assigned to a randomization group."
723127|NCT02307838|This extension study was a multicenter follow-up study of participants who enrolled in FTY720D2201 (NCT02307838). Although participants in this study did not receive study treatment, the participant flow is based on the treatments receive in FTY720D2201.|A total of 177 participants were enrolled into the study. However, 2 participants were erroneously enrolled into the study because they did not meet the inclusion criteria. Therefore, they were not included in any analyses, and as such, the participant flow is based on 175 participants.
723128|NCT02307682|Subjects were recruited from investigative sites located in Argentina, Australia, Canada, Colombia, Israel, Japan, Mexico, New Zealand, Panama, Puerto Rico, and USA.|Of the 1775 subjects enrolled in the study, 693 were exited prior to randomization as screen failures. This reporting group includes all randomized subjects.
723129|NCT02307552||
723130|NCT02307526||
723131|NCT02307513|The study was conducted at 53 sites in Europe (France, Germany, Greece, and Italy), Asia (Japan and the Republic of Korea), the United States, and Rest of the World (Israel, Lebanon, and Turkey).|Participants were stratified by gender, history of uveitis and region (Japan and Other Regions).
723132|NCT02307318||
723133|NCT02307266||
723134|NCT02307188|Five (5) patients were enrolled. The catheters were used in the left atrium in one (1) patient. The remaining patients were excluded because of subtherapeutic activated clotting time levels < 300 seconds (3 patients) or presence of prosthetic valve (1 patient).|
723135|NCT02307123||
723136|NCT02306928||
723137|NCT02306850||
723138|NCT02306759|This was a single-center, prospective, randomized, double-blind, placebo-controlled trial comparing the use of SDDK versus placebo as an adjunct therapy for moderate to severe acute pain in the ED. The study was conducted in a community teaching hospital with a level-2 trauma ED where more than 77,000 patients are treated annually.|
723139|NCT02306694||
731482|NCT01695304||
731483|NCT01695291||
723144|NCT02305758||All randomized participants. Although the study was terminated by the Sponsor, because all participants were evaluated for the primary end point, the study was considered to have Completed as planned.
723145|NCT02305732||
723146|NCT02305446|Subjects will be enrolled at one site in Poland from December 2014 to February 2015.|All enrolled subjects will be included in the trial and assigned to the same treatment group.
723147|NCT02305381|The trial was conducted at 90 sites in 5 countries, as follows: Germany: 10 sites; Japan: 6 sites; Serbia: 4 sites; Slovakia: 5 sites; United States: 65.|
723148|NCT02305329||
723149|NCT02305316||
723150|NCT02305277||
723151|NCT02305238|Study was conducted in Japan between 19 December 2014 (first participant first visit) and 08 November 2017 (last participant last visit).|288 participants were enrolled and 255 entered run-in phase. 8 were randomization failures. 247 participants were randomized (2 Weeks [2W] adjustment group: 124; 4 Weeks [4W] adjustment group: 123) at Week 16. All 247 participant:s were treated and 227 participants (111 in the 2W adjustment, 116 in the 4W adjustment) completed Week 52 treatment.
723152|NCT02305017||
723153|NCT02304926||
723154|NCT02304705||
723155|NCT02304484|This study was conducted at 126 centers in 29 countries in the regions of Europe, North America, Asia Pacific, and Latin America. Participants were enrolled from 24 November 2014 to 31 August 2016.|Participants who successfully completed week 80 of the parent Study 20120153 (NCT01813422) and did not discontinue study drug in the parent study for any reason were eligible for this study. All participants received open-label evolocumab.
723156|NCT02304432||
723157|NCT02304406||
723158|NCT02304380|Claims data records for 64,382 participants were analyzed to address Claims Data Analysis (Aim 3).|64,382 met eligibility criteria for inclusion in the claims data analysis which was non-human subjects research.
723159|NCT02304367|"This study is being conducted at 8 centers in the United States. Results are reported through 11 January 2019, through 144 weeks of treatment.
~The study enrolled adults with tumor-induced osteomalacia (TIO) or epidermal nevus syndrome (ENS)-associated osteomalacia."|
723160|NCT02304159||
723161|NCT02303743||
723162|NCT02303704||
723163|NCT02303574|This study was conducted at PAREXEL Early Phase Clinical Unit London, Level 7, Northwick Park Hospital in London. Healthy male and female participants were enrolled.|In Part 1 and Part 2, participants underwent a screening visit within 28 days before receiving the first dose of investigational medicinal product (IMP). Participants were admitted to the study centre 1 day before administration of the IMP (Day -1).
723164|NCT02303548||
723165|NCT02303262||
723166|NCT02303041||
723167|NCT02302859|Recruitment Period Opened January 2015 and Closed March 2016. Recruitment was accomplished in clinic setting of a large comprehensive HIV-care center.|
723168|NCT02302846|Recruitment Period: May 2015 through March 2016. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.|Of the five participants enrolled in this study, three were evaluable for response. One participant was evaluable for toxicity. A fifty participant was registered but did not receive therapy due to the patient's decision to continue a prior therapy.
723169|NCT02302807||
723170|NCT02302716||
723171|NCT02302365||
723172|NCT02302339||
723173|NCT02302222||
723174|NCT02302092|Participants took part in the study at 4 investigative sites in Russia from 01 December 2015 to 15 Feb 2016.|Participants with a diagnosis of complicated urinary tract infections were enrolled in 1:1 ratio to flomoxef or cefepime arm groups.
723175|NCT02302066|Participants took part in the study at 3 investigative sites in Dominican Republic, Panama and Philippines from 05 Dec 2014 to 18 Feb 2019.|Healthy volunteers were enrolled in a 1:2:5:1 ratio into 4 study groups: Group 1 received two doses of Tetravalent Dengue Vaccine (TDV), Group 2 received one dose of TDV, Group 3 received one dose of TDV along with booster vaccination and Group 4 received placebo.
723176|NCT02301988||
723177|NCT02301975|Eligible participants at screening and run-in visits entered a 24 Week treatment period and were randomized to receive either Fluticasone furoate/Vilanterol (FF/VI) 100/25 micrograms (mcg) or Fluticasone propionate/salmeterol (FP/S) 250/50mcg or only FP 250mcg followed by a follow-up phase. The total duration for study participation was 30 weeks.|A total of 3162 adult and adolescent participants with asthma were screened, out of which 516 were screen-failures, 1124 were run-in failures, 1522 participants were randomized, and 1504 subjects received at least one dose of study medication to be included in the Intent-to-Treat (ITT) Population.
723178|NCT02301936|Participants were enrolled at 1 study site in the United States. The first participant was screened on 02 March 2015. The last study visit occurred on 18 April 2016.|
723179|NCT02301897||
723180|NCT02301793|Nurses were identified using our centralized education directory that associates nurses with their designated departments and hospital floors. On July 23, 2014, nurses were cluster randomized by floor to receive one of two education modules about VTE prevention. Nurses were asked to complete their assigned education module by October 23, 2014.|Pre Education Study Period reflects the baseline participants information (patient visits). Post Education Study Period reflects the participants information following the implementation of the nurse education intervention.
723181|NCT02301624|Participants who completed Study ECU-MG-301 (NCT01997229) were eligible to participate in Study ECU-MG-302.|
723182|NCT02301546||51 individuals were enrolled in the study but were withdrawn by the research team because they did not meet criteria for amnestic Mild Cognitive Impairment on objective testing.
723183|NCT02301429||
723184|NCT02301416|Retrospective chart review patients were not considered enrolled, but historical data was used as a comparison so it is included.|
723185|NCT02301403|Participants were patients from seven primary care clinics within two Wisconsin healthcare systems. Smokers who expressed interest in quitting smoking during a clinic visit were referred via the electronic health record (EHR) to the research study. Other smokers from these clinics were recruited via mailings and EHR messaging.|Primary care patients who passed the phone screen were invited to attend a study visit at their referring clinic to learn more about the study, have eligibility confirmed, and provide written informed consent. No enrolled participants were excluded from the study prior to assignment to groups.
723193|NCT02300987|Subjects were randomly assigned to Ribociclib or Placebo in a 2:1 ratio. The 2 subjects from the placebo group (primary phase) entered the secondary treatment phase (cross over) after they experienced disease progression, and were then treated with LEE01. One patient from the LEE arm entered the secondary treatment phase.|42 subjects were planned to be included (28 for the LEE011 arm and 14 for the Placebo arm). The study was stopped prematurely with 10 patients randomized and treated in this study (8 in the ribociclib arm, 2 in the placebo arm).
723194|NCT02300727||
723195|NCT02300610|Participants were recruited at Moffitt Cancer Center and the University of Minnesota Masonic Cancer Center, February 2015 through August 2017.|
723196|NCT02300558|Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 17 December 2014. The last study visit occurred on 15 February 2017.|54 participants were screened.
723197|NCT02300545|The study opened to participant enrollment on 04/08/2015 and closed to participant enrollment on 02/20/2019.|
723198|NCT02300311||Multinational, multi-centre, randomised, double-blind, placebo-controlled, parallel group, 2-arm study with a treatment duration of up to 4 days
723199|NCT02300298|This is a single arm study but it was allowed to discontinue the docetaxel treatment and continue the nintedanib treatment.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that they (the patient) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
723200|NCT02300259||This study planned to enroll 3 groups. After Groups 1 and 2 were enrolled, data from Group 2 were analyzed according to a pre-specified algorithm. Results met criteria to enroll Group 4. (Group 3 was not enrolled.)
723201|NCT02300129||
723202|NCT02300103|Participants were enrolled at 31 study sites in North America and Asia Pacific. The first participant was screened on 01 December 2014. The last study visit occurred on 15 September 2016.|74 participants were screened.
723203|NCT02300077|Recruitment was done between March 2015-May 2016.|We withdrew 4 patients after consenting - two of patients met exclusion criteria, one patient withdrew consent, one anesthesia provider refused to participate the study.
723204|NCT02300025||
723205|NCT02299934||
723206|NCT02299869||One participant was disqualified from the study due to not meeting inclusion criteria before lens dispensing.
723207|NCT02299791|Recruitment was done at the clinic level. All patients seen in the clinics were potentially eligible for the intervention based on clinic visit and clinical criteria.|
723208|NCT02299635||
723209|NCT02299570|Recruitment was from 12/10/14 to 11/13/15 at 21 medical clinics in the United States and Canada. Recruiment was performed by trained investigators and study coordinators.|Seventeen enrolled subjects did not proceed to randomization and were exited from the study. Of the 133 randomized subjects remaining, five subjects chose to withdraw prior to treatment and in one subject the first blinded enema was not able to be initiated due to anxiety and the subject subsequently chose to withdraw.
723210|NCT02299479|Twenty participants aged 1 to 17 years were recruited at Boston Children's Hospital beginning in July of 2015.|
723211|NCT02299427||
723212|NCT02299388||
723213|NCT02299375|This was a randomized, double-blind (sponsor unblinded), parallel-group, multi-center study evaluating 15 milligrams (mg) twice daily (BID) of losmapimod versus placebo in addition to standard of care in male and female participants (par.) >=40 years of age having chronic obstructive pulmonary disease (COPD).|This study consisted of a 28 day screening period followed by treatment period (TP) of minimum 26 weeks. Total duration of TP was variable from 26 weeks to 52 weeks, and safety follow-up after 1 week. Total 365 par. were screened (175 par. failed), of which 190 par. passed screening and 184 par. were randomized in a TP.
723214|NCT02299349||
723215|NCT02299336||
723216|NCT02299297||
723217|NCT02299258||
723218|NCT02299206||Arms are combined for overall number of participants. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined.
723219|NCT02299167|Four independent anesthetists were assigned for the study from January 2014.one to select patients in the anesthesia clinic, the 2nd to prepare the studied drug in the OR, the 3rd one to inject the drug and the 4th one was to collect the data|35 patients were enrolled However; after they have signed the consent. 7 patients were excluded because they have received analgesics in the morning of surgery. and 4 patients refused the saddle block in the operating room. So actually 24 patients out of 35 participants underwent intervention. That has been already specified in the protocol
723220|NCT02299089||
723221|NCT02299076|"Recruitment period: January to March, 2016. Recruitment methods: Physician and nurse referrals from Rhode Island Primary Care Physicians Corporation and Facebook advertisements.
~Intake method: Digital intake form hosted by Pro-Change."|We identified and discontinued 34 participants whose accounts were were flagged as being suspicious. Duplicate accounts were erroneously created by a participant and thus were removed from the study. Suspicious accounts contained personal information identical to existing participants and after investigation, were concluded to be fraudulent.
723222|NCT02299050||
723223|NCT02298946||
723224|NCT02298933||
723225|NCT02298868||
723226|NCT02298842||87 volunteers signed consent and were enrolled in the study, but 2 were screen fails and therefore did not participate in the study
723227|NCT02298803|Patients with type 2 diabetes attending the Diabetes Centre, Royal Prince Alfred Hospital who fulfilled the entry criteria were approached to participate. The requirements of the study were discussed and participants were given a copy of the Participant Information Sheet and Consent Form to read. 30 individuals were recruited in 2015.|30 participants were screened and enrolled. Data from all 30 participants was included in the analysis.
723228|NCT02298361||
723229|NCT02298322||
723230|NCT02298192|The trial was conducted at 80 sites in 9 countries as follows:Austria: 6 sites; Bulgaria: 5 sites; Canada: 7 sites, Czech Republic:5 sites; Hungary: 4 sites, Russian Federation: 6 sites; Serbia: 4sites, Slovakia: 7 sites; United States: 36 sites.|Stable daily treatment with metformin (≥1500 mg or max tolerated dose) ± pioglitazone (≥30 mg) for at least 90 days prior to screening
737296|NCT01326910||
723242|NCT02296853|Participants were enrolled at study sites in Germany, New Zealand, and the United States. The first participant was screened on 22 December 2014. The last study visit occurred on 17 April 2015.|28 participants were screened.
723243|NCT02296840|Participants were recruited between November 2014 and February 2016.|Eight of the 53 individuals who consented to taking part in the study did not meet eligibility criteria, resulting in 45 participants who began the intervention.
723244|NCT02296775|"The study was conducted in 2 parts, a treatment and evaluation period (Part 1) and a recovery and follow-up period (Part 2).
~Study period was between November 2014 to June 2017 in a total of 29 sites across India and Ukraine."|The study was having 6 weeks screening period to accommodate 4 weeks washout/run-in stabilization and screening procedures.
723245|NCT02296606||
723246|NCT02296502||
723247|NCT02296476|Participants had a confirmed diagnosis of de novo glioblastoma multiforme (World Health Organization grade IV astrocytoma) with tumor recurrence following standard front-line treatment with surgery, cranial radiotherapy and temozolomide. Other inclusion and exclusion criteria applied.|
723248|NCT02296424|182 enrolled but 16 qualified immediately for Part II & were randomized while 166 continued in Part I & were treated with canakinumab 4 mg/kg every 4 weeks until study end unless they discontinued, or until they qualified for Part II. Of these, 40 discontinued. Most frequent reason was lack of efficacy|75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
723249|NCT02296346||
723250|NCT02296320|The study was conducted between 10Oct2014 and 02Oct2018.|A total of 767 participants consented to participate in the study, of which 554 were screen failures. A total of 213 participants were randomized in the study.
723251|NCT02296242|Up to 6 study centers were to enroll up to 20 AML or MDS patients for Part 1 (dose-escalation) and 40 evaluable patients (≤ 20 RAS mutant positive AML or MDS patients and ≤ 20 RAS mutant negative AML or MDS patients) for Part 2 (cohort expansion). The last patient completed in May 2017.|
723252|NCT02296190|Adults aged 18 years and older with Paroxysmal supraventricular tachycardia (PSVT) who met the study inclusion/exclusion criteria. Study was initiated on March 27, 2015 and completed on December 8, 2016 and was performed in electro-physiology clinics in the USA and Canada.|
723253|NCT02296164|The study registered 301 consecutive adult patients (Only registered/not enrolled:1; Enrolled: 300) diagnosed with MF-CTCL and being treated with Valchlor, regardless of other MF-CTCL therapies received before or at enrollment. All patients were enrolled from 46 participating centers/clinics in university-affiliated or community hospitals in the US|All consecutive MF-CTCL patients being treated with Valchlor were invited to enroll in this study. Two patients were not eligible as they were not on Valchlor at time of study start
723254|NCT02296138|A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD.|Following informed consent, the patient was entered into a maximum 7-day screening period to confirm the patient's eligibility. At Visit 2, after a successful review of the inclusion and exclusion criteria, the patient was randomly allocated in equal ratio to receive once daily trial treatment and then entered the 360 days treatment phase.
723255|NCT02296125|A total of 556 participants in Global cohort (out of 673 participants in Global and China cohorts) were randomized to treatment at 132 study centres in 29 countries. An additional 117 participants in 19 centres were enrolled into the China extension cohort only.|During the 28 day screening period, participants were enrolled based on the presence in their tumour of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations. At the time of enrolment, all participants were required to provide biopsy tissue for central testing of the Exon 19 deletion (Ex19del) and L858R mutations
723256|NCT02296112||
723257|NCT02296099||
723258|NCT02295995||
723259|NCT02295774||
723260|NCT02295735|"The study was conducted in a tertiary care hospital from June 2015 to July 2018 at the Charite Universitaetsmedizin Berlin, Germany. Patients were recruited from seven ICUs.
~In total, 7575 ICU patients were screened for eligibility and 475 ICU patients were included."|
723261|NCT02295644||
723262|NCT02295553||
723263|NCT02295280|This was a prospective randomized, controlled trial at a single perinatal care center, conducted from December 2012 through September 2014 and approved by the IRB at Saint Louis University.|
723264|NCT02295020||
723265|NCT02294981||One patient lost to follow-up
723266|NCT02294786|The study enrolled 62 women in 17 centers; Czech Republic (1), Israel (1), Poland (3), the United Kingdom (4) Russian Federation (8)|The study was terminated early after 62 patients (out of 140 planned) were randomized as criteria for futility was met.
723267|NCT02294773|Patients recruited from two clinical offices from 1/2014 until 9/2015.|
723268|NCT02294734|The study consisted of a screening visit, a 12-week treatment period, and a 1-2 week post-treatment follow-up. The total duration of the study was 13-14 weeks including the screening visit.|Approximately 120 participants with an acute exacerbation of chronic obstructive pulmonary disease (COPD) were randomized (1:1) to GSK 2269557 1000 micrograms (µg) and placebo such that approximately 100 participants complete the study. Participants were also stratified by whether they were willing and able to provide sputum samples at screening.
723269|NCT02294682|This was a phase II, randomized, multicenter, open-label, dose ranging study evaluating the efficacy, safety and tolerability of gepotidacin therapy in participants with uncomplicated urogenital gonorrhea. The study duration was approximately 1 week with 2 planned study visits: Baseline (Day 1, pre-dose) and Test-of-Cure (TOC) (Day 4 to 8) visit.|A total of 106 participants (par.) were randomized to receive GSK2140944 1500 milligrams (mg) or GSK2140944 3000 mg, of which 105 participants received any dose of study treatment and 1 par. was unable to swallow the capsule; therefore, did not receive study drug.
723270|NCT02294604||
723303|NCT02291679||A total of 2244 participants were screened; 1223 were randomized and 1021 were not randomized (478 participants were screen failures and 543 participants were pretreatment failures).
723373|NCT02286713|Recruitment Period: March 2015 to September 2016 from tobacco quitline new and former callers.|After consent participants completed baseline assessments prior to randomization.
723271|NCT02294474|The study was conducted at 103 centers in 12 countries. A total of 707 participants were screened between 14 January 2015 and 24 July 2015, of which 202 were screen failures. Screen failures were mainly due to glycated hemoglobin (HbA1c) level <6.5% or >10% at screening visit.|A total of 505 participants were randomized and treated in the study. Randomization was stratified by HbA1c at the screening visit (<8%, >=8%) and prior use of Humalog (Yes, No). Assignment to arms was done centrally using interactive voice/web response system in 1:1 ratio (SAR342434: Humalog).
723272|NCT02294461|The study population consisted of men with asymptomatic or mildly symptomatic progressive metastatic prostate cancer, who had failed androgen deprivation therapy, and have not been treated with cytotoxic chemotherapy. Participants from 46 study sites in 4 countries (China, Korea, Taiwan and Hong Kong) were randomized for the study.|Data cutoff date for the efficacy and safety data is 20 Sept 2015 and for the final PK analysis data cutoff date is 20 Jan 2016. Study completed double-blind period and is now in the open-label period.
723273|NCT02294396|Participants with overactive bladder (OAB) were enrolled in 60 sites in Japan.|Prior to randomization, participants received 50 mg mirabegron orally once daily after breakfast for 2 weeks during a screening period.
723274|NCT02294318||
723275|NCT02294253||
723276|NCT02294227|There were 341 patients originally randomized to one of 2 trearment groups. Seven placebo patients discontinued before week 16 and therefore not switched to treatment. Only 334 patients received secukinumab treatment.|Patients were randomized 1:1:1.
723277|NCT02294175||
723278|NCT02294058|The study was conducted at 152 sites in 20 countries in Eastern and Western Europe, the United States, and New Zealand. Between December 2014 and November 2015, 1656 participants were screened, of whom 1346 were eligible and enrolled.|Participants were randomly assigned to one of three treatment groups in a 1:1:1 ratio. Randomization was stratified by Baseline Expanded Disability Status Scale (EDSS) score (≤ 3.5, > 3.5) and country.
723279|NCT02294019||Participants were screened by phone,then referred to their participating retail pharmacy site for scheduled face-to-face interview,after which they were given an empty ibuprofen 400 milligram (mg) caplet over-the-counter (OTC) package to review information on outside of entire package,then decision was made to purchase medicine by them.
723280|NCT02293902|The study was conducted at 95 centers in Japan between 06 November 2014 and 28 October 2016. A total of 388 participants were screened, of whom 243 participants were randomized and 145 were screen failures.|Participants were randomized to receive sarilumab 150 mg, 200 mg or placebo in a double-blind period up to Week 24 followed by single-blind period during which participants originally given placebo were switched to sarilumab 150 mg or 200 mg; those originally given 150 mg, 200 mg in double-blind period, continued with same treatment up to Week 52.
723281|NCT02293863|Enrolled in the study were 168 participants. The participant flow is reported for the safety population (158 participants), which included all randomized participants who received study drug, with participants grouped according to the treatment actually received.|
723282|NCT02293798||
723283|NCT02293538|A total of 234 participants were recruited from 6 investigational centers located in the United States.|Of the 234 enrolled, 84 participants were exited from the study as screen failures and 6 participants were discontinued prior to randomization. This reporting group includes all randomized and treated participants (Intent to Treat) (144).
723284|NCT02293512||
723285|NCT02293460|Between 24 February 2015 and 22 March 2017, 59 subjects from 23 sites signed an informed consent.|"59 subjects signed an informed consent in the pre-assigment period. Among them, 18 subjects were considered as a screening failure including 3 subjects re-screened and finally enrolled.
~Of 44 enrolled subjects, on subject was discontinued (consent withdrawn by subject) from the study before the first administration of study drug."
723286|NCT02293395||A total of 3,145 participants were screened for eligibility, of these 108 participants were screening failures and the remaining 3,037 participants were randomized.
723287|NCT02293044||
723288|NCT02292927||
723289|NCT02292849||
723290|NCT02292784|This was a randomized, long-term follow-up study to evaluate the safety and outcomes of infants and children born to women who received retosiban or comparator in the Phase III spontaneous preterm labor (SPTL) treatment studies:200719 (NCT02377466) and 200721 (NCT02292771). Current study was referred as a retosiban infant outcome study (ARIOS).|A total of 101 participants were screened and 98 participants were enrolled and randomized in this study.
723291|NCT02292771|ZINN was a randomized, double-blind, double-dummy multicenter study to compare efficacy and safety of retosiban versus atosiban in female participants aged 12 to 45 years with an uncomplicated singleton pregnancy in preterm labor with intact membranes between 24 0/7 and 33 6/7 weeks gestation.|From 330 planned participants 97 were randomized to receive either retosiban or atosiban intravenous (IV) infusion in a ratio of 1:1. The study was terminated early due to feasibility.
723292|NCT02292758||
723293|NCT02292719||The study included a 35-day screening period.
723294|NCT02292537||After parental informed consent was obtained and prior to any treatment, participants entered a Screening Period of up to 21 days to determine their eligibility for the study. Of the 179 participants screened, 53 were screening failures.
723295|NCT02292446||161 patients were included in the ruxolitinib arm and 100% of the patient's received the treatment
723296|NCT02292433||
723297|NCT02292212|The patients on hemodialysis at one clinical site in Canada were enrolled to this study. The first patient was enrolled on November 24, 2014 and the last patient on July 13, 2015.|
723298|NCT02292186||
723299|NCT02292082||
723300|NCT02291913|Between December 2014 to December 2015, 48 patients who had locally recurrent or metastatic breast cancer with cytologically or histologically confirmed hormone receptor-positive breast cancer who have demonstrated disease progression on prior anti-estrogen therapy. Study was closed after enrollment goal was reached.|
723301|NCT02291861|This study was performed at 75 study centers (38 in the US, 19 in Poland, 7 in Hungary, 6 in the Czech Republic, 3 in Slovakia, and 2 in Germany) by 75 investigators; 298 patients were enrolled.|Participants were randomly assigned in a 1:1:1:1 ratio to receive 1 of 3 fixed-dose regimens of SD-809 (deutetrabenazine) or placebo following a screening period.
723302|NCT02291718||
723519|NCT02275546||
731674|NCT01683864|Study was early terminated due to recruitment problem. All active patient have study|
723304|NCT02291549|Patients were recruited at 40 sites across the US between December 2014 and May 2016, of which 34 sites enrolled at least 1 patient.|Patients were considered enrolled into the study after signing the ICF and entered a 2-week screening period. A video-recorded screening endoscopy and symptom scoring, using a daily diary, were required to confirm patient eligibility. Video-endoscopies were assessed by an independent reviewer in order to confirm bilateral polyposis.
723305|NCT02291510||
723306|NCT02291419||
723307|NCT02291302||
723308|NCT02291289||
723309|NCT02291237|Participants were enrolled at study sites in Asia, Australia, Europe and North America. The first participant was screened on 05 February 2015. The last study visit occurred on 22 February 2017.|264 participants were screened.
723310|NCT02291029|A total of 69 patients were enrolled in Germany (1 center), Hungary (1 center), Switzerland (1 center), United Kingdom (3 centers), United States (3 centers)|
723311|NCT02291016||
723312|NCT02290925|All recruitment carried out in medical clinic, Teaching Hospital anuradhapura|"Run-in period was 8 weeks and if the variability of the HbA1c is more than 20%, participants were excluded. This was done to exclude patients with fluctuating glycaemia.
~Wash out for 1 month after 1st period of giving treatment for 3 months. After the wash out patients are crossed over for the other biscuit given for another three months"
723313|NCT02290873||
723314|NCT02290821||
723315|NCT02290691|Study participants were enrolled from 05 November 2014 to 15 January 2015 at six clinical centers in the United States.|A total of 984 participants who met all inclusion criteria and not of the exclusion criteria were enrolled and vaccinated in the study.
723316|NCT02290613||
723317|NCT02290574||
723318|NCT02290509||
723319|NCT02290444||
723320|NCT02290431|Approximately 33 eligible subjects were planned to be enrolled. 31 eligible subjects were enrolled and treated with PAN+BTZ+Dex (Treatment phase 1), of which 17 subjects entered Treatment phase 2. All 31 subjects entered the post-treatment evaluation phase, of which 22 discontinued the study. 24 subjects entered the survival follow-up phase.|
723321|NCT02290340|Participants were recruited between January 2015 and September 2015 at 10 sites (USA, South Africa, and Chile) and followed for 1 year after dosing.|A total of 151 participants were screened in the study, of which 89 participants were randomized and treated.
723322|NCT02290223||
723323|NCT02290184|All potential participants are invited to complete a pre-telephone screening. Those who pass the pre-telephone screening are potentially eligible to participate in the study and invited to attend a screening baseline visit where they are asked to complete a physical exam, serum blood tests, and a 2 week run-in period.|"During the 2-week run-in, eligible participants are asked to wear Fitbit pedometer every day for 10 hours/day, take photos with their smart phone of each meal for 3 consecutive days, and email these photos to research study email.
~Those who pass the physical exam, serum lab test, and run-in period are then randomized to one of two study groups."
723324|NCT02290106||
723325|NCT02289989|Recruitment was done in the department of dermatology of Rutgers-RWJMS. It was stopped in July 2016.|No exclusions or significant events were observed in the study.
723326|NCT02289963|The study was conducted at 27 centers in South Korea and Taiwan. Overall 316 participants were screened between January and September 2015, of whom 117 were screen failures. Screen failures were mainly due to exclusion criteria met.|Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke, intensity of statin treatment and country. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1 ratio (Placebo:Alirocumab). A total of 199 participants were randomized.
723327|NCT02289898||A total of 207 subjects were randomized and 204 subjects were treated in the study.
723328|NCT02289833|Subjects were screened centrally for HER2 status, using archived tumor specimens from previously collected tissue, if available.|
723329|NCT02289820|A total of 363 participants were screened. Of these, 264 participants were enrolled.|A total of 264 participants were enrolled in the study. Of the 264 randomized participants, 3 participants did not receive the study drug. 261 participants were included in the As-treated Population.
723330|NCT02289755|Subjects (N = 16) were recruited from 3 centers in the United States between August 2014 and December 2014.|History of ≥1 calcium oxalate kidney stone within the last 2 years, secondary hyperoxaluria and a mean urinary oxalate of ≥36 mg/day
723331|NCT02289742|Subjects were recruited from 1 study center located in Germany.|Of the 48 enrolled subjects, 3 were discontinued as screen failures prior to randomization. This reporting group includes all randomized subjects (45).
723332|NCT02289729||A total of 62 participants were enrolled; 59 were evaluable and 3 were non-evaluable because they did not participate in the nasoduodenal test phase and they did not receive any dose of levodopa/carbidopa intestinal infusion gel (LCIG).
723333|NCT02289690|The study was conducted at 52 study sites located in 12 countries (Australia, Belgium, Canada, Czech Republic, France, Hungary, Korea, the Netherlands, Romania, Russian Federation, Spain, United States).|Participants in Phase 1 were sequentially assigned to ascending dose levels of veliparib in combination with standard carboplatin/etoposide regimen. Participants in Phase 2 were randomized equally to placebo, carboplatin/etoposide followed by placebo maintenance, or to veliparib, carboplatin/etoposide followed by veliparib or placebo maintenance.
723334|NCT02289469||A total of 250 patients were enrolled into the intervention group. However, only 244 patients could be matched to suitable controls, and 6 were therefore excluded from the analysis of results. Thus the number of patients recruited was 494 (250 intervention + 244 control), but results are presented for 488 (244 intervention + 244 control).
723335|NCT02289456|This multicenter study was conducted in the United States (US) and enrolled participants at 7 sites.|Included participants with confirmed Stage IIIB or IV non-small cell lung cancer and measurable disease at study entry per Response Evaluation Criteria in Solid Tumors Version 1.1 with an Eastern Cooperative Oncology Group Performance Status of 2 and no prior anticancer therapy for the treatment of metastatic disease.
723372|NCT02286895|Recruited up to 750 healthy male and female infant subjects of 9-11 months of age from the local communities and community health centers in Bamako, Mali. The duration of planned study participation for each subject was to be approximately 3 months and the estimated duration of the recruitment period was to be 3 months.|
737297|NCT01326845||
723336|NCT02289417|The study was conducted at 61 sites in Australia (3 sites) and New Zealand (1 site); Bulgaria (6 sites), Czech Republic (2 sites), Hungary (3 sites), Poland (9 sites), Russia (1 site), and Ukraine (10 sites); Canada (2 sites) and United States (13 sites); and France (4 sites), Germany (1 site), Italy (4 sites), and the Netherlands (2 sites).|A total of 170 participants were randomized in a 1:1:1 ratio and received apremilast (30 mg BID or 40 mg BID), or identically appearing placebo and stratified based on concomitant use of oral corticosteroids and previous exposure to immunosuppressants.
723337|NCT02289352||"514 patients were screened for study participation and 462 patients were randomized and included in the statistical analysis.
~The populations for this study included the Safety population, the Per-Protocol (PP) population and the modified Intent-to-Treat (mITT) Population."
723338|NCT02289222|Participants were recruited from the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center between December 2014 and May 2016.|
723339|NCT02289157|Patients recruited in the Parkland Hospital Maternal-Fetal Medicine High Risk Clinic, on the Antepartum Floor, in Labor and Delivery, and in the preoperative holding area. January 2015 until July 2016. 850 screened. See Figure 1 Flow Diagram.|Patients were excluded for pre-specified exclusion criteria and if they delivered vaginally after consent was obtained. 850 patients were screened. 173 declined participation, 5 withdrew consent, 2 delivered at outside facility, 211 delivered vaginally, 10 did not meet inclusion criteria, and 8 not identified to be enrolled.
723340|NCT02289105||
723341|NCT02289079||
723342|NCT02288819|Outpatient cardiology clinic of a single tertiary centre (Ziekenhuis Oost-Limburg, Genk, Belgium) between December, 2014, and February, 2016.|
723343|NCT02288559||"A total of 332 participants were screened and 92 participants were randomized out of which 3 participants from one site were removed from the randomized population due to serious good clinical practice (GCP) noncompliance. Out of 89, 4 participants were excluded from the randomized population as they did not have any post-baseline measurement.
~."
723344|NCT02288364|88 participants signed consent. 86 participants were randomized.|
723345|NCT02288325||
723346|NCT02288312||
723347|NCT02288273||239 subjects were screened in order to randomize 117 subjects; however, 116 subjects were included in the modified intent to treat population, which consisted of all randomized patients who received at least one dose of randomized study drug.
723348|NCT02288182||
723349|NCT02288091||
723350|NCT02287922|A total of 251 subjects were recruited at 58 sites located in Europe (42 sites; 199 subjects), Latin America (6 sites; 36 subjects) and North America (10 sites; 16 subjects). Consent was obtained from the first subject on 18 Mar 2015; the last subject completed the final visit in on 19 Jul 2016.|Of the 599 subjects screened, 348 were screen failures and 251 subjects were randomly assigned to treatment (Intent-to-treat population). All subjects enrolled received study treatment and were included in the safety population. All subjects who received at least one dose of ALX-0061 were included in the pharmacokinetic (PK) population.
723351|NCT02287909||87 patients entered a run-in phase. Of these, 7 withdrew during run in.
723352|NCT02287896||100 subjects were pre-screened in the pre-assigment period, only 62 subjects were included in the study.
723353|NCT02287883|Adult patients with diabetes and/or cardiovascular disease from sixteen primary care practice sites at two Accountable Care Organizations (ACOs) in the US (greater Los Angeles and Chicago areas) were surveyed about their patient reported outcomes (PROs), patient assessment of chronic illness care (PACIC) and patient activation and engagement (PAM).|Sixteen primary care practices at two ACOs in the US (greater Los Angeles and Chicago), were selected based on their responses to a 39-item questionnaire of their patient activation and engagement activities. 4168 eligible patients from these sites were included in the baseline survey. 2176 of these patients responded and were included in the study
723354|NCT02287818||
723355|NCT02287779|Study was conducted at one study centre in North America, from 19 January 2015 to 19 June 2015.|Overall, 84 participants were randomised and completed the study.
723356|NCT02287688|There were 5,612,052 members of Kaiser Permanente of Southern California (KPSC) health plan during the study period. Among these,108,325 were children 2 to 23 months old. A total of 144 subjects aged 2 to 23 months who received at least one dose of MenACWY-CRM vaccine, were enrolled in this study.|Out of the 144 subjects enrolled, only 138 subjects were analysed in this study as 6 subjects did not meet the inclusion criteria.
723357|NCT02287675||
723358|NCT02287636||
723359|NCT02287623||
723360|NCT02287610||In total, 75 participants enrolled in the study, 11 of them did not meet eligibility requirements and therefore were not included.
723361|NCT02287584|Participants were conducted in 8 countries/region between December 2014 and October 2018.|In this study, 675 subjects provided informed consent, 580 of 606 subjects.
723362|NCT02287467||
723363|NCT02287415||
723364|NCT02287402|Participants took part in the study at 30 investigative sites in Japan from 9 March 2010 to 15 November 2012.|Participants with impaired glucose tolerance (IGT) who had been non-responsive to diet therapy and exercise therapy receive one AO-128 0.2 mg tablet orally 3 times a day before meals.
723365|NCT02287376||
723366|NCT02287350||
723367|NCT02287038|The participants are explained the nature, purpose, and procedure of the study and asked to sign an informed consent that will explain the potential risks and benefits of the study participation. Primary, secondary outcome measures, and physical examination will be conducted at baseline and all subsequent visits by a qualified research clinician.|Week 1: Screening; Week 2 to 5: Phase 1 (ATX in group 1 and placebo in group2); Week 6: Wash-out; Week 7 to 10: Phase 2 (Crossover, Placebo in group1 and ATX in group2).
723368|NCT02287025|The study was conducted at 10 study centers in United States, from 11 NOV 2014 (first subject first visit) to 26 FEB 2016 (last subject last visit).|Of the 23 screen participants, 2 participants were screen fails, 2 consented but never started treatment due to early study termination and 19 patients entered treatment.
723369|NCT02286960||
723370|NCT02286947||The study was conducted at 9 sites in the United States from November 2014 to March 2018.
723371|NCT02286921||27 participants were not assigned to intervention due to screen failure, withdrawn consent, or PI decision.
737519|NCT01313286||
737848|NCT01294306||
723374|NCT02286518|Participants took part in the study at 1 investigative site in Japan from 17 Nov 2014 to 29 April 2015.|Healthy Japanese, Caucasian participants enrolled in study with 3 parts to receive TAK-114 single rising dose (SRD) (10 milligram [mg], 20 mg and 50 mg, once daily) in Part 1, TAK-114 20 mg in fasted and fed conditions, cross-over in Period 1 and 2 of food effect Part 2 and TAK-114 multiple rising dose (MRD) (20 mg, 50 mg twice daily) in Part 3.
723375|NCT02286466|Participants were screened and enrolled at Massachusetts General Hospital Cancer Center in Boston, MA and Lee Memorial Regional Cancer Center in Fort Myers, FL.|
723376|NCT02286193|Enrollment period was 15 months, from July 2014 - December 2015.|"This was a single group observational study. All patients were considered enrolled who received care at one of 3 pilot clinics and were referred or self-referred to receive services from the Community Resource Specialist (CRS). They were considered complete if after referral they completed at least 1 phone or in-person CRS visit."
723377|NCT02286102||
723378|NCT02285998||Excludes 40 subjects who received randomization numbers, but who either withdrew prior to vaccination (n=15) or for whom the vaccine received could not be verified (n=25; 12 assigned to Flublok quadrivalent and 13 assigned to IIV4).
723379|NCT02285920||
723380|NCT02285907||
723381|NCT02285855|A total of 18 lung non-small cell lung cancer (NSCLC) patients were consented and randomized. Eligible criteria: pathologic diagnosis of AJCC Stage I-II, cT1-T2N0M0, can be treated with hypofractionated radiotherapy, not a surgical candidate, have adequate renal function within 30 days prior to registration, and plans to receive treatment at MDACC.|A total of 27 patients were consented to this study, but 9 patients withdrew consent prior to protocol medication or treatment. 18 patients randomized and treated under this protocol.
723382|NCT02285777|189 subjects were enrolled from 1 center in United States|An Interactive Response Technology (IRT) was used in the study. At Month 6 Visit of the parent study, IRT allocated the study vaccines (either MenABCWY or placebo) to the subject. Subject received either a 3rd dose of MenABCWY or one dose of a placebo, depending on their assigned vaccine group in parent study.
723383|NCT02285634|Healthy volunteers over the age of eighteen that have been recently dismissed from the Emergency Department at Mayo Clinic Hospital, Saint Marys Campus beginning 11-12-14.|None to report
723384|NCT02285283||
723385|NCT02285270||
723386|NCT02285153||
723387|NCT02285062|The study has completed enrollment but is ongoing. 177 community, academic and government sites randomized participants in Australia, Belgium, Canada, China, the Czech Republic, France, Ireland, Israel, Italy, Japan, the Netherlands, New Zealand, Poland, Portugal, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey and the United States.|"Participants were randomized in a 1:1 ratio to either lenalidomide-(R2)CHOP or placebo-R-CHOP, and stratified by International Prognostic Index (IPI) Score 2 or ≥ 3, age: < 65 or ≥ 65 years and presence of bulky disease: diameter of the lesion ≥ 7.0 cm (bulky) or < 7.0 cm (nonbulky).
~."
723388|NCT02285023|Patients diagnosed as chronic idiopathic urticaria were invited to participate in the study at the Allergy clinic in the Department of Dermatology, Siriraj Hospital, Mahidol University, Bangkok, Thailand.|
723389|NCT02285010|142 patients on gynecology unit during December 2014 - January 2016 were assessed for eligibility, 17 patient were not randomized due to didn't meet inclusion criteria (n=6), met exclusion criteria (n=4), declined to participate (n=7).|
723390|NCT02284906|Participants took part in the study at 3 investigative sites in Australia, United Kingdom and United States from 12 Feb 2015 to 08 May 2018.|Participants with who have completed the pivotal AD-4833/TOMM40_301 (NCT01931566) study with an adjudicated diagnosis of mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) were enrolled to pioglitazone (0.8 mg sustained release tablet) or placebo.
723391|NCT02284893|461 Patients were Randomized into the study, 411 patients completed the 26 weeks part. Out of them 402 patients continued into the additional 26 week part. Out of them 378 patients completed the 52 weeks period (26+26 weeks).|
723392|NCT02284880||
723393|NCT02284867|Our study was conducted at Ain Shams University Maternity Hospital during the period between August 2012 and December 2014. A total of 60 pregnant women were included in the study.|Adequate placental tissue sampled and proper primary storage technique then proper way of staining
723394|NCT02284854||
723395|NCT02284828||
723396|NCT02284568||A total of 447 patients were screened for enrollment into this study. Of the patients screened, 374 patients met entry criteria and were enrolled into the study. One participant withdrew before taking any study drug.
723397|NCT02284555||
723398|NCT02284516||"Two participants from placebo arm (N=356) has taken study drug by mistake and considered for Lifitegrast arm (N=355). Therefore, Placebo (N=354), Lifitegrast (N=357) were considered for safety analysis."
723399|NCT02284464||Of the 230 patients, 125 were not randomized because of: screening failure 74; patient wishes 16; acute rejection 9; graft loss 9; died 3; lost to follow-up 1 and other causes 13. The main causes of screening failure were: creatinine >2 mg/dl and subclinical rejection in the protocol biopsy at the third month. 105 patients were finally included
723400|NCT02284399||
723401|NCT02284386||
723402|NCT02284373||
723403|NCT02284347||
723404|NCT02284243||
723405|NCT02284178||
723406|NCT02284165|Starting population = 164,246 acute ischemic stroke patients with data in Get With the Guidelines linked to Medicare fee-for-service (FFS) claims. This was a retrospective analysis of existing data, so there were no patient milestones.|The following exclusions were applied prior to group assignment: death during index admission (n=10,466); loss of FFS eligibility not due to death during follow-up (n=1683); discharged to Federal hospital (n=102); transferred to another acute care hospital or discharged directly to nursing home for long-term care (n=4279).
723407|NCT02284009|This was a multicenter study conducted at 29 sites in Europe (Spain 10, United Kingdom (UK) 9, Germany 4, France 3 and Italy 3). A total of 67 participants with New-onset type 1 diabetes mellitus (NOT1DM) were randomized.|Study was terminated early as part of the decision to withdraw albiglutide for commercial reasons. Study stopped after 67 participants were randomized instead of 68 as per protocol. Impact of early termination was minimal and did not affect the interpretation of results.
723408|NCT02283840||
723409|NCT02283827||
723410|NCT02283814||
723411|NCT02283788||
723412|NCT02283762|The study was conducted between 15 January 2015 (first patient first visit) and 28 March 2019 (last patient last visit). The Main Treatment Phase has been conducted between 15 Jan 2015 (first subject first visit) and 03 Jan 2018 (last subject last visit for the main treatment phase).|"139 patients were screened in 60 study centers in 15 countries worldwide. 121 patients of 139 patients were randomized and treated with at least one dose of study medication.
~88 of the 121 randomized patients completed the treatment phase, of whom 87 entered the long term extension (LTE) phase."
723413|NCT02283749||
723414|NCT02283658||
723415|NCT02283528||
723416|NCT02283411||
723417|NCT02283268|Enrollment was conducted at 14 study sites in 10 countries (USA, Australia, Taiwan, Germany, Russia, Spain, Ukraine, United Kingdom, Italy, Turkey).|A total of 24 participants were enrolled (signed informed consent) and screened. Of these, 15 participants were treated with investigational product.
723418|NCT02282982||
723419|NCT02282930||
723420|NCT02282904||
723421|NCT02282813|Subjects could enroll in extension study after completing trials CTAP101-CL-3001 or CTAP101-CL-3002. Subjects from 68 sites participated with at least 1 subject enrolled in the extension per site. Three sites participated in both blinded trials.|Treatment groups were categorized as treated for 26 weeks; subjects previously on placebo in predecessor trials) or 12 months (52 weeks; subjects previously on active treatment in predecessor trials). Following 12 weeks, a subset of eligible subjects (n=up to 90) could be randomized to take adjunctive therapy in addition to CTAP101 capsules.
723422|NCT02282722||216 participants were consented to this study. Of these, 16 were were not eligible to be randomized and 14 did not complete a baseline assessment. After consultations with the study statistician, these participants were intentionally excluded from our analytic cohort. Therefore, 186 participants are included in the participant flow module.
723423|NCT02282631|"School recruitment took place from late May 2014 to early July 2014. I emailed and phoned schools from my office, and then met personally with the two selected schools in mid July 2014.
~Family recruitment took place in mid September 2014. Invitations were distributed to children at school and returned by parents by post."|"Recruitment of schools: one invitation email, second email two weeks later (reminder) and phone call (one week after reminder). Four schools replied positively out of 123 contacted (3.3%).
~Recruitment of participants: 29 (33.0%) returned a valid consent form before baseline; 2 returned a consent form after the start of baseline and were excluded"
723424|NCT02282605||Persistent nasal SA carriage was defined by 3 separate, SA positive cultures from nasal swabs. The protocol allowed for dosing to commence before the results of the final swab on day -1 were available. Dosing was thus commenced in 3 subjects in the XF-73 2.0mg/g group but was withdrawn as the day -1 SA results were negative.
723425|NCT02282527|This study was performed at 6 investigative centers in the US.|
723426|NCT02282293||
723427|NCT02282163|"Study Initiation Date (first subject enrolled): 20 October 2015; Study Completion Date (last subject completed study related activities): 20 January 2018. Enrolment was at 2 sites in the US.
~Even though last subject enrolled was 20 January 2018, FDA release from completion of enrolment was 31 May 2018. Blinded read completion was 13 August 2018."|"The study was terminated early due to challenges with enrollment. At the time of termination, 13 subjects were enrolled and 12 subjects were dosed with Lumason, thus the efficacy analysis was considered as exploratory and p-values are not included in the Results section.
~PK assessment was not performed due to enrollment difficulties."
723428|NCT02282111||Patients were excluded from the study because a predominantly cystic lesion was found; the lack of an appreciable mass at Endoscopic Ultrasound scan (EUS).
723429|NCT02282020|A wash-out period of up to 5 weeks was required for participants who have previously taken potent inhibitors or CYP3A4/5 inducers.|Participants were randomized in a 2:1 ratio between olaparib and selected chemotherapy.
723430|NCT02281955|Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), Rex Hospital (Raleigh, NC), High Point Regional Health (High Point, NC), and Pardee Memorial Hospital (Hendersonville, NC).|115 patients were accrued. One patient voluntarily withdrew prior to treatment. One patient died during treatment secondary to neutropenic sepsis.
723431|NCT02281851||
723432|NCT02281773|A phase II multi-centre, multi-national, randomised, double-blind, placebo-controlled parallel group trial to evaluate the efficacy, safety and tolerability of four orally administrated doses of BI 409306 during a 12-week treatment period in patients with schizophrenia on stable antipsychotic treatment.|Actually, 518 subjects were entered/randomised however 2 subjects were not treated and hence the number of subjects that started equals 516. One belongs to BI 409306 - 25 milligram and another to Placebo group.
723433|NCT02281591||
723434|NCT02281552||
723435|NCT02281526||
723436|NCT02281500|The study was conducted in India, Lebanon, and the United States of America (USA) between 22 Jul 2016 (first participants first visit) and 11 Nov 2019 (last participant last visit).|A total of 26 participants were screened, out of which 24 participants were enrolled, of them 2 participants withdrew the consent prior to receiving the study treatment, and the remaining 22 participants received the study treatment.
723437|NCT02281448||
723438|NCT02281422||
723439|NCT02281357|First patient enrolled: 19 February 2015; Last patient last visit: 07 September 2017. Study performed at 56 sites in 7 countries. Patients were maintained on their currently prescribed inhaled corticosteroid long-acting β2-agonist therapy and any additional asthma controller medications throughout the study period.|218 patients were screened. Prior to randomisation, patients completed a run-in period or run-in/oral corticosteroid (OCS) optimisation period (reached their minimum effective dose of OCS and remained stable on that dose for 2 weeks). 140 patients were randomised to study treatment. All randomised patients received study treatment.
723440|NCT02281344||
723441|NCT02281318||A total of 830 participants (par.) were screened (Visit 1) and entered into the run-in period, of which 556 participants were randomized and 551 participants received either mepolizumab 100 milligrams (mg) or placebo in addition to standard of care asthma treatment.
723442|NCT02281136||
723748|NCT02255552|The study was conducted at 40 sites in the United States.|"A total of 109 participants were enrolled in the study. Only 79 participants were treated and the remaining participants were not applicable for treatment as those participants assessed under Untreated arm."
723443|NCT02281084|Participants were randomized at 33 sites globally. The sites were located in: Australia (3), Europe (18) and the United States (12). Results are reported as of the data cut-off date of 19 June 2019.|Participants were eligible who did not respond to an adequate course of therapy with an injectable hypomethylating agent (iHMA - azacitidine or decitabine) or were unable to tolerate an iHMA following at least 3 months of attempted treatment.
723444|NCT02280863|Adults were recruited in the first 2 cohorts. Following analysis of the adult cohorts, adolescents were recruited in the third cohort.|
723445|NCT02280811||
723446|NCT02280655|Subjects recruited from Emory University Hospital. 142 patients were screened and of those, 99 failed screening or were excluded.|
723447|NCT02280499||"93 patients were assessed for eligibility. Two participants were excluded before receiving the intervention due to not meeting the inclusion criteria.
~Four enrolled subjects did not receive a PROMOS™ prosthesis due to different reasons but were changed to another shoulder implant which was not part of the study."
723448|NCT02280473||
723449|NCT02280421|"Participants took part in the study at one investigative site in United Kingdom from 06-October 2014 to 10-February 2015
~Each participant was randomised to 2 groups. One group was received ASP 400mg in first intervention and 1200mg in other group. There was a washout of at least 2 weeks between the interventions."|Participants received a single dose of 400mg or 1200mg ASP2151 on Days 1 and 7, 100 mg ciclosporin twice daily on Days 3-9, and once in the morning of Day 10. Two participants were withdrawn during the washout period, in the second intervention, another participants were replaced.
723450|NCT02280408||
723451|NCT02280304|A total of 364 Veterans were pre-screened. Flyers were posted at the VA and at the University of Houston; however, most of the people who responded had been contacted in Mental Health and Neurology clinics.|Of 364 Veterans pre-screened, 85 were invited to come in for further eligibility assessment for PTSD, mTBI, and exclusionary disorders. Of these, 33 did not attend or excluded themselves, leaving 46 enrolled. Of these, 9 dropped out before group assignment, and 15 dropped out post group assignment, leaving a total of 22 finishing the study.
723452|NCT02280291||
723453|NCT02280252|The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available|
723454|NCT02280226||
723455|NCT02280200||
723456|NCT02280187||
723457|NCT02280122||
723458|NCT02280096|Twenty-four patients were recruited, of whom 21 completed the study|Three patients were excluded: one because of lack of adherence to the treatment; another presented an anxiety crisis and third one due to pregnancy. In the end, 11 patients were included in the treatment group and 10 in the placebo (control) group.
723459|NCT02280044||Per protocol, a total of thirty subjects were admitted to the inpatient unit and randomized to receive investigational product on day -1 to ensure the target sample size was obtained. Two subjects received three doses of product but were discharged on Day 0 prior to challenge. Both subjects were randomized to the placebo arm.
723460|NCT02279862||"82 participants were enrolled; 53 were randomized; 51 were treated with study drug. 29 were not randomized due to screening failures. 2 were randomized and not treated due to administrative reason by sponsor and other reason"
723461|NCT02279732||342 participants enrolled, 295 were randomized to ipilimumab (148) and placebo arms (147). After chemotherapy, double blinded study treatment, which was the focus of the study, was started.Of all randomized participants, only 98 (ipilimumab arm) and 106 (placebo arm) participants received at least one dose of blinded study therapy.
723462|NCT02279667||
723463|NCT02279641|12 subjects were randomized|Twelve subjects were randomized to 1 of 2 treatment sequences (Sequence A or B) in a 1:1 ratio.
723464|NCT02279498||
723465|NCT02279420||
723466|NCT02279407|This study was conducted in 5 centers in Sweden between 20 January 2015 and 11 December 2015.|The study duration was up to 15 weeks: an screening period of up to 2 weeks, a 12-week treatment period, and a follow-up visit 1 week after the last dose of study drug. A total of 223 patients signed informed consent; data was not recorded for 1 patient and 18 were screened twice. Therefore, 204 patients were screened, and 84 were randomized.
723467|NCT02279173|Children with immune thrombocytopenic purpura (ITP) and platelet counts ≤ 30×10⁹/L or uncontrolled bleeding were enrolled from December 2014 to August 2016 at 66 centers in 16 countries worldwide, including Eastern Europe (44%), Western Europe (25%), and US/Canada (21%).|"All participants were assigned to receive weekly romiplostim.
~A subset of participants enrolled under a protocol supplement in the European Union (EU), Switzerland, and Turkey were enrolled into the following 2 cohorts:
~bone marrow biopsy and aspirate at baseline and year 1
~bone marrow biopsy and aspirate at baseline and year 2"
723468|NCT02279160||
723469|NCT02279108||
723470|NCT02279082||
723471|NCT02279043||
723472|NCT02278952|Lung transplant recipients treated at UCSF with tacrolimus-based immunosuppressive regimen recruited one to two months post-transplant.|Participants followed for 6 to 18 months post transplantation. Study visits performed within one day of a clinical bronchoscopy scheduled either for cause, such as suspected infection or rejection, or for surveillance at 2, 3, 6, 12, or 18 months.
723473|NCT02278939||
723474|NCT02278783||
723475|NCT02278640||
723476|NCT02278614||
723477|NCT02278562|This study was conducted at the VA Nashville and the Vanderbilt University Medical Center between October 2014 and March 2017.|There is about a 2-week screening period between enrollment and assignment to a treatment group to access inclusion/exclusion criteria. Although 33 subjects were enrolled, only 24 subjects were assigned to a treatment group (6 subjects were screen failures and 3 subjects withdrew prior to being randomized).
723478|NCT02278484|Sequential enrollment of eligible participants at sites.|
723479|NCT02278471||Potentially eligible participants were invited to complete a baseline visit. During baseline visit, if eligibility confirmed, patients then randomized in open-label 1:1 fashion to either polypill arm or usual care arm. Only if baseline visit labs yielded an exclusionary result were participants then disqualified from further study participation.
723480|NCT02278367||
723749|NCT02255500||
728205|NCT01921452||All 283 enrolled participants were analyzed using both point-of-care (POC) thyroid stimulating hormone (TSH) kits and third generation TSH kit.
723481|NCT02278354|Enrollment occurred between Feb 2015 and Feb 2017|Five subjects enrolled in the study but did not receive a flortaucipir PET scan (2 active, 3 retired). Two additional subjects in the active fighters group did not have the minimum 10 fights required for inclusion into the study, and therefore were considered not to have completed the study. However, their PET scan results were analyzed.
723482|NCT02278341|Study population consisted of participants with end-stage renal disease (ESRD) who were on stable hemodialysis (HD) or peritoneal dialysis (PD), and were also on stable treatment with epoetin (i.e. epoetin alfa, beta, theta, zeta, delta or omega) or darbepoetin alfa for anemia.|Participants were randomized in a 1:1 ratio to roxadustat or ESA (epoetin alfa or darbepoetin alfa). Randomization was stratified by 5 factors: previous ESA treatment, region, history of cardiovascular, cerebrovascular or thromboembolic diseases, average weekly ESA dose 4 weeks prior to randomization and the screening hemaglobin (Hb) value.
723483|NCT02278328||
723484|NCT02278263|The hospital databases will be searched for eligible patients on the waiting list for unilateral total knee joint replacement. Patients will be approached in the preadmission clinics and then consented on the day of surgery. Recruitment period is to be over 2 years or sooner once we have recruited the final patient (n=150)|Patients were excluded after consenting to participate, if they failed to receive spinal anaesthesia.
723485|NCT02278237||
723486|NCT02278146||
723487|NCT02278120|Approximately 660 patients were planned to be randomized in a 1:1 ratio to one of the following treatment arms: Ribociclib (LEE011) arm and Placebo arm.|
723488|NCT02278003||
723489|NCT02277990||There were 92 total patients that were enrolled into the study, but not randomized. After enrollment, but prior to randomization, 2 patients died, 31 patients were found to not meet eligibility criteria, 50 patients withdrew, 1 investigator withdrew the patient and 8 patients had an other or unknown reason for not being randomized.
723490|NCT02277925||
723491|NCT02277769|The study was conducted in 10 countries between 03 December 2014 and 21 January 2016. A total of 962 participants were screened in the study.|Out of 962 participants, 708 were randomized and 707 were treated in the study. Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw.
723492|NCT02277743|The study was conducted in 10 countries between 28 Oct 2014 and 12 Feb 2016. A total of 917 participants were screened in the study.|Out of 917 participants, 671 were randomized and 669 were treated in the study. Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw.
723493|NCT02277691|Participants took part in the study at 31 investigative sites in Japan, from 07 November 2014 to 25 April 2016.|Participants with diagnosis of essential hypertension were enrolled in 1 treatment group:TAK-536CCB (TAK-536/ AML,20 mg/5 mg) in run-in period (Week -4 to 0).
723494|NCT02277665|Participants were enrolled between 12/2014 to 09/2016 at Dartmouth College and the University of Washington. Participants were recruited from ads posted online (Craigslist, Facebook), in newspapers, on radio, community posters, and notices to service agencies. All activities occurred at stand-alone, University associated research clinics.|All those who enrolled were assigned to a treatment condition
723495|NCT02277639||
723496|NCT02277626||
723497|NCT02277548||
723498|NCT02277444||
723499|NCT02277249||
723500|NCT02277119||
723501|NCT02277093||
723502|NCT02277054||
723503|NCT02276963|This was a single center, phase I open label study of ublituximab in NMOSD patients with acute relapses. Patients aged 18-65 who presented to the Johns Hopkins Hospital between January and September 2016 with new neurologic symptoms were eligible for enrollment if they demonstrated a new contrast-enhancing lesion on MRI.|There were no pre-assignment events.
723504|NCT02276872||
723505|NCT02276807|Participants were recruited from three VA primary care clinics in Western New York from March 2015 through March 2018 . Eligible participants (i.e., age > 18 years of age, receiving services in those clinics, and reporting depressive symptoms) were identified via medical record review, study flyers posted in clinics, and direct referrals.|A two-part screening process identified those eligible to continue into the study based on additional set of eligibility criteria, such as at least moderate symptoms of depression and stable course of antidepressants or outpatient psychotherapy for anxiety, PTSD, or substance use.
723506|NCT02276638||
723507|NCT02276612|Participants were enrolled at study sites in South Africa and the United States. The first participant was screened on 03 December 2014. The last study visit occurred on 23 October 2017.|68 participants were screened.
723508|NCT02276560||
723509|NCT02276482||All participants who were enrolled and provided informed consent/ascent were randomized to one of two treatment groups.
723510|NCT02276274|Participants took part in the study at 1 investigative site in Japan from 21 June 2014 to 22 July 2014.|Healthy participants were enrolled in 1 of 2 treatment groups: SYR-322-MET fasted followed by SYR-322-MET fed; SYR-322-MET fed followed by SYR-322-MET fasted.
723511|NCT02276222||
723512|NCT02276053|The study started to enroll patients in November 2014 and concluded in December 2017.|The Participant Flow refers to the Safety Set (SS), which was defined as all patients included in the study receiving treatment with LCM at least once in the study.
723513|NCT02276040||
723514|NCT02276027|Participants were from China|To enter the screening phase, the subjects' molecular alterations were determined using locally validated methodologies from a newly obtained tumor sample or the most recent archival tumor sample available. Based on the molecular alterations of the tumor, subjects were assigned to one of the treatment arms. Subjects with multiple molecular alterations in epidermal growth factor receptor and the relevant pathways were excluded, except under the conditions described in Inclusion criteria.
723515|NCT02275923||
723516|NCT02275780||A total of 1027 participants were screened and 769 were randomized. This report covers results for the 96-month Base Study. Results for the ongoing open-label study extensions will be reported when the extensions are completed.
723517|NCT02275767||
723518|NCT02275611||The numbers of subjects recruited into the withdrawal study alone, outpatient study alone, or both = 13. Some people dropped out of the inpatient withdrawal phase after they completed that phase. Additional participants were added for the second, outpatient phase.
723520|NCT02275481|Before recruitment and enrollment, each prospective subject was given a full explanation of the study, allowed to read the approved informed consent form and was provided ample time and the opportunity to ask any questions that may have arose.|Once all questions had been answered and the Investigator was assured that the prospective subject understood the implications of participating in the study, the prospective subject was asked to give consent to participate in the study by signing the informed consent form.
723521|NCT02275364|Participants were recruited at a clinical site in London.|A total of 35 participants were screened of which 28 were randomized in the study. Five of these did not meet study criteria, 1 had a protocol violation and 1 additional participant had other reason to leave the study, prior to be randomized.
723522|NCT02275338|Subjects diagnosed with inoperable malignant intestinal obstruction were recruited into this single arm, open label study in 15 study centres in Belgium between November 2014 and November 2017.|Overall, 52 subjects were enrolled into this 2 phase study.
723523|NCT02275156|Eighteen participants were enrolled at 1 center in the United States. The first participant enrolled on 19 August 2014 and the last participant enrolled on 28 October 2014.|
723524|NCT02275117||A total of 1552 participants signed the ICF, of which 665 participants met the entry criteria and were randomized into the trial.
723525|NCT02275065|Participants were enrolled at study sites in United States. The first participant was screened on 24 October 2014. The last study visit occurred on 29 January 2015.|33 participants were screened.
723526|NCT02275052|Participants (par.) who met the eligibility criteria at screening, entered the 11- to 25-day Run-in period followed by two 12-week Double-blind treatment periods that were separated by 12- to 17-day washout period. The total duration of participation, including the follow-up, was approximately 30 weeks.|A total of 374 par. were screened, of these, 10 par. were pre-screen failures, 132 par. were screen failures and 34 par. were run-in failures; 198 par. who were randomized into the study and received treatment were included in the Intent-to-Treat (ITT) Population.
723527|NCT02274948|"Obese (defined as ≥+2SD of BMI for age, WHO 2007 standards) children of 8-16 years of age were identified through a separate screening programme carried out in all schools in the Negombo educational zone and were invited to participate in this study.
~Study commenced in July 2014"|"Selected children were invited to participate in the research and provide clinical service. Consent from parents and assent from children obtained.
~After baseline assessment randomly assigned to receive one of the two management protocols on a 1:1 basis. Children were stratified according to gender and age groups; 8-10.99; 11-16 years"
723528|NCT02274870||
723529|NCT02274857||
723530|NCT02274844|Recruitment efforts in this area focused on attending health fairs, posting flyers at community locations such as libraries and churches. The main focus of recruitment was in the county's safety net clinic.|
723531|NCT02274792|This study was conducted at 39 centers in North America (United States and Canada). The first participant enrolled on 29 January 2015 and the last participant was enrolled on 08 May 2015.|
723532|NCT02274766|77 subjects with Parkinson's disease (PD) and Levodopa-induced Dyskinesia (LID) were randomized at 32 study sites in the United States, Germany, France, Spain, and Austria. The first subject was randomized on 23 October 2014 and the last subject completed on 10 March 2016.|All randomized subjects who received ≥ 1 dose of study drug and provided ≥ 1 postbaseline efficacy assessment (75) were included in both the Safety Analysis Population and the Modified Intent-to-Treat (MITT) population (with 38 subjects in the placebo group and 37 in the ADS-5102 group).
723533|NCT02274688||
723534|NCT02274675|The recruitment started on 1st June 2014 for 4 months duration in a stroke rehabilitation centre.|
723535|NCT02274649|All patients admitted to SCI inpatient rehabilitation program from April 1 2014 to April 30, 2015 were recruited.|If planned discharge location was to non-community location, participants were not assigned to group and excluded from study
723536|NCT02274558|This study enrolled patients with schizophrenia or schizoaffective disorder with tardive dyskinesia (TD) or mood disorder with TD from 63 centers in North America and Puerto Rico. The last patient completed in August 2016.|
723537|NCT02274493||
723538|NCT02274311|Acromegalic patients with uncontrolled hormonal levels despite current medical treatment|Patients should be on stable medical treatment for at least 6 months prior entering the study. Patients submitted to radiotherapy in the last 10 years were not eligible.
723539|NCT02273973|The study recruited post-menopausal participants with breast cancer in 22 countries from November 2014 to March 2017.|
723540|NCT02273960||46 participants were enrolled in the study and 26 participants entered the treatment period. Of the 20 who did not enter the treatment period, 19 did not meet study criteria and 1 experienced an adverse event.
723541|NCT02273908|The recruitment was conducted from Jun. 2014 to Dec. 2014 at 33 study sites.|
723542|NCT02273752|Patient were recruited at Winship Cancer Institute of Emory University from November 2014 to December 2015.|
723543|NCT02273323|53 subjects were screened between August 2014 and and October 2015|All 30 subjects meeting the inclusion criteria were randomised
723544|NCT02273310||
723545|NCT02273206||Among the 802 participants who were recruited for the study, 759 completed the baseline assessment and were randomized to one of the two intervention groups. Two participants were found to be ineligible after randomization and were excluded; as a result, 757 participants are included in the analyses.
723546|NCT02273180|The study was conducted at 89 centres in 8 countries. A total of 668 participants were screened between 28 October 2014 and 04 June 2015, of which 161 participants were screen failures. Screen failures were mainly due to glycated hemoglobin A1c (HbA1c) level <7.0% or >10% at the screening visit.|A total of 507 participants were randomized in the study. Randomization was stratified by HbA1c at the screening visit (<8%, >=8%), prior use of Humalog/Liprolog (Yes, No) and geographical region (Non-Japan, Japan). Assignment to arms was done centrally using interactive voice/web response system in 1:1 ratio (SAR342434: Humalog).
723547|NCT02273167|The trial recruited out/in-patients at 29 medical centres in Europe, from October 2014 to June 2015.|
723548|NCT02273141|The trial recruited out/in-patients at 19 medical centres in Europe, from November 2014 to July 2015.|
723549|NCT02273115||
723550|NCT02273063||
723823|NCT02249793|Study Started 9/24/14, Ended 3/11/15 located at the Clinical and Translational Research Center, CTRC located at the University of Pennsylvania Hospital|
723551|NCT02273050|The study was conducted in 25 centers between 18 December 2014 and 03 August 2016.|The study duration was up to 27 weeks, consisting of an initial screening period lasting up to 2 weeks, a 1-week lead-in period, and a 24-week treatment period. The number of subjects who signed the ICF is 1136, the number of subjects randomized is 640.
723552|NCT02273037||
723553|NCT02272985||
723554|NCT02272816||
723555|NCT02272803||90 participants were enrolled; 82 were randomized and treated. Participants were enrolled but not treated because they no longer met study criteria (n=7) or they withdrew consent (n=1).
723556|NCT02272790|This multi-center study was conducted at 20 sites: 18 in the USA, 1 in Canada, and 1 in The Netherlands. Ninety-five (95) patients were enrolled; 94 patients received treatment. The first patient started treatment on 2 Feb 2015; the final patients were still receiving treatment and were censored at the time of database lock on 14 Dec 2018.|One hundred twenty-six (126) patients consented and underwent screening; 94 patients passed screening, whereas 32 patients failed screening tests and were not eligible. The Full Analysis Set consists of 94 patients.
723557|NCT02272777|This study was conducted at 13 centers in China.|Patients continued treatment of the drug they were taking at the end of CAMN107ECN02 (NCT01275196). The starting dose had to be the same as the last dose that was given in the core study. After this, dose was based on the investigator's judgment.
723558|NCT02272725||
723559|NCT02272686|Recruitment Period 6/3/2016 to 2/21/2017.|Ibrutinib maintenance will not be started if patient relapses post transplant
723560|NCT02272413|Phase III, randomized, double-blind, multicenter, active comparator, parallel 2-arm trial in patients with advanced non-squamous non-small cell lung cancer (nsNSCLC). From 21December2017, Sponsor recommended, patients to be switched from BI 695502 to reference product Avastin® (commercially available) as soon as it was available at clinical site.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that they (the patients) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were violated.
723561|NCT02272244|2,720 study invitation letters sent to subjects from 5 practices that appeared to meet eligibility criteria based on medical records.|"2,320 were excluded
~98 contact not attempted (recruitment goals met or known ineligible)
~504 were determined up to date on screening
~182 were ineligible for other reasons
~256 refused
~717 were unable to be contacted
~563 were wrong numbers"
723562|NCT02271984||Subjects were randomized to receive a sequence of 5 treatments over 5 treatment periods. A total of 36 were enrolled subjects, three in each of the 12 possible sequences were distributed.
723563|NCT02271945|The study was conducted from 01Dec2014 to 24May2016.|A total of 16 participants were screened in this study. Of which, 6 participants failed screening and 10 participants were enrolled in the study and received the study drugs.
723564|NCT02271906|Two patients with untreated resectable Stage IA to IIIA non-small cell lung cancer were recruited at the University of Texas MD Anderson Cancer Center.|Following registration, patients should begin protocol treatment within 2 weeks. If a patient does not receive protocol therapy within 2 weeks following registration, the patient's registration on the study may be canceled at the discretion of the study investigators and the patient will be considered a screen failure.
723565|NCT02271880||No enrolled participants were excluded from the study prior to assignment to groups.
723566|NCT02271854|Study Start 7 Oct 2014 and End 24 dec 2014|
723567|NCT02271698|45 participants signed consent. 3 participants withdrew prior to randomization|
723568|NCT02271529||
723569|NCT02271477||
723570|NCT02271451||
723571|NCT02271425||
723572|NCT02271386|Note: The same group of 105 clinicians participated during both periods. Charts were reviewed for a different random sample of patients in each period (790 patients in total: 391 in the baseline and 399 in the intervention period)|
723573|NCT02271217||
723574|NCT02270983||14 calendar days (minimum) to 21 calendar days (maximum) before randomization, participants had to provide information about bowel habits, symptom severity, and rescue medication use through daily IVRS calls. A total of 254 patients were randomized to treatment.
723575|NCT02270957||
723576|NCT02270944|1053 subjects were enrolled at Belgium, US and Czech Republic sites.|Among the 1053 subjects enrolled in the study, 3 subjects were randomized but didn't receive the vaccine. The 3 subjects were excluded and didn't start the study.
723577|NCT02270684||
723578|NCT02270671|"Approximately 2,900 students were invited to take part through Irish second-level schools. N=545 provided assent and parental consent. N=12 were excluded based on exclusion criteria and N=36 were absent for screening.
~N=497 completed screening of which N=130 met the inclusion criteria. Data were collected between September 2014 and May 2015."|
723579|NCT02270645||
723580|NCT02270515|The PCMH-KD model was implemented at two dialysis centers, an academic dialysis center and a private dialysis center. Patients were recruited, screened and enrolled at both sites. After consenting, study participants completed a baseline survey and on a rolling basis three follow-up interviews at six, twelve, and eighteen months.|"Clinical data (six months prior to enrollment date) was collected from the electronic medical record for all participants to compare the usual care for enrolled patients with the care received during the PCMH-KD intervention."
723581|NCT02270255|Between April 2015 and February 2017, 87 patients were approached for enrollment. All patients fit the inclusion criteria, and no patients were excluded. However, 43 of the 87 patients (49%) declined participation in the study, leaving 44 patients (51%) who agreed to participate.|No enrolled participants were excluded from the study. Data were complete for all participants up to the time of discharge from the postanesthesia care unit (PACU). Forty-three of the 44 participants (98%) completed the home survey; one participant (2%) was lost to follow-up.
723582|NCT02270242|From July 2015 through December 2017, 9006 patients were enrolled, and 7119 underwent randomization after 3 months|1887 excluded from randomization (106 lost to follow up, 243 had adverse events between enrollment and randomization: a) myocardial infarction, stroke or death, b) revascularizations, and/or c) BARC type 3b or higher bleedings, 1148 were not adherent to DAPT, 267 withdrew consent or declined to participate, and 123 had other reasons.)
723824|NCT02249767||
723825|NCT02249728|Participants were screened and enrolled into one study site in the United Kingdom.|
723583|NCT02270060||Following verbal consent on the day of an ACC visit, an RN escorted the participant into the ACC to receive standard care that included vital signs, a lab draw, assessment by a nurse practitioner, and scheduled analgesics. The assigned study condition occurred one hour after participants' first dose of analgesics.
723584|NCT02269943|This was a multicenter study with 17 sites from the United States, Canada, France. Greece, Italy, Spain, Taiwan, Singapore and Tunisia.|Participants were enrolled according to a Simon 2-stage design. The first 6 participants of Asian-Pacific Island ethnicity received 200 mg/day CC-486 on days 1-14 of each 21-day cycle to monitor safety and tolerability; if there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity would receive the 300 mg daily dose
723585|NCT02269917||Results are reported through Week 48 (primary analysis). Complete data through final analysis (including extension through Week 96 and follow-up) will be reported within 1 year of end of trial date when final data based on study completion date will be available. Total 1149 participants were randomized out of which 1141 were treated.
723586|NCT02269787||
723587|NCT02269709||
723588|NCT02269657|Outpatient adolescent idiopathic scoliosis (AIS) patients were prospectively recruited from the orthopedic clinic at Children's Hospital of Philadelphia. Males and females ages 10-18 years with a diagnosis of AIS with no previous spinal surgery were included.|
723589|NCT02269631||
723590|NCT02269488|"In visit 1,
~Obtain written informed consent.
~Verify eligibility criteria.
~Complete baseline procedures including a medical history and current medication use.
~Perform physical examination .
~Administer study products."|
723591|NCT02269475|Of the 1369 consented, 68 were excluded after screening.|
723592|NCT02269423||
723593|NCT02269241||
723594|NCT02269098||
723595|NCT02268994||1 randomized subject was excluded because they did not receive study drug and were excluded from the safety population.
723596|NCT02268955||
723597|NCT02268942||
723598|NCT02268877||
723599|NCT02268864||
723600|NCT02268851|Participants in the Phase I portion of the study enrolled in outpatient clinic setting from 11/20/2014 to 12/22/2018 and to the Phase II study from 1/14/2016 to 5/29/2018. The MCL and CLL arms were enrolled independently of each other, and were allowed to begin enrolling to the protocol scheduled expansion independent of the other arm.|
723601|NCT02268812||
723602|NCT02268786||
723603|NCT02268526|Cohort 1: Six patients were planned for enrollment; 6 patients were enrolled. Cohort 2: Eighty patients were planned and 80 were enrolled.|
723604|NCT02268396|Conducted at 10 study sites in the United states from November 2014 - January 2015. The entire study period was scheduled to take approximately 6 weeks for each individual subject. The study was anticipated to run for approximately 6 months.|Study was an open-label, multi center study to evaluate the accuracy, reliability, and functionality of GFF MDI dose indicator in adult subjects with moderate to very severe COPD over a 4-week treatment period.
723605|NCT02268214|The first subject was enrolled on 11 November 2014. The last subject completed the 24-week short-term treatment period 04 January 2017 and the last subject completed the study 25 August 2017. This study was conducted at 138 sites in 17 countries.|833 participants were randomized to a treatment group. Of the 771 participants not randomized to a treatment group: 585 No longer met study criteria, 125 withdrew consent, 26 were lost to follow-up, and 35 did not continue for other reasons
723606|NCT02268175||
723607|NCT02268058|Youth presenting to pediatric tertiary centre ED within 48 hours of concussive event and having headache.|
723608|NCT02268045||An additional cohort of 16 patients was added (as per Iran local regulatory requirements) to the planned sample of 256 patients. The extension cohort of Iran was only considered for safety analysis.
723609|NCT02267850||
723610|NCT02267837||
723611|NCT02267824||
723612|NCT02267811||
723613|NCT02267746||893 subjects were randomized and analyzed; 869 qualified for the mITT population and 758 for the PP population.
723614|NCT02267629||
723615|NCT02267603||
723616|NCT02267577||
723617|NCT02267538||
723618|NCT02267447||
723619|NCT02267382||A total of 254 subjects were enrolled in the 14-day open-label Induction Phase of the study after providing consent. Those subjects whose acute VVC infections resolved during the Induction Phase (a total of 215) entered the Maintenance Phase of the study.
723620|NCT02267356||
723621|NCT02267317||
723622|NCT02267278|Recruitment Period: January 2015 to March 2017|Of the twenty-five participants who started the study, five never began pracinostat and are not considered evaluable for response.
723623|NCT02267226||
723624|NCT02267187||
723625|NCT02267135||
723626|NCT02267083||
723627|NCT02266914|Recruitment period: January 27, 2014 to December 7, 2014 (approximately 1 year) at The Ohio State University Wexner Medical Center.|
723628|NCT02266888|Seven sites in the United States enrolled 45 participants into this trial.|
723629|NCT02266875||
723630|NCT02266810||
723631|NCT02266797||
723632|NCT02266706|Participants were screened for eligibility within 48 hours prior to study drug administration.|After interim analysis, dose level adjustments were made to some groups based on safety and pharmacokinetics targets. Thus, the initial 6 cohorts were expanded to a total of 9 cohorts for analysis.
723633|NCT02266576||
723634|NCT02266472||This was an open-label, randomised, 2-way crossover trial with 2 treatments (T and R) and 2 treatment sequences (T_R and R_T). Trial drug administrations of the 2 single dose treatments were separated by a washout period of at least 7 days.
723635|NCT02266433|Patients will be enrolled from the private office of orthopaedic hand surgeons (Dr. Paksima and Dr. Sapienza) and the resident hand clinic at NYU Hospital for Joint Diseases held at the 23rd street clinic.|
723826|NCT02249585||
723827|NCT02249377||
723828|NCT02249182|Participants were enrolled at study sites in the United States, United Kingdom, Australia, and New Zealand. The first participant was screened on 05 November 2014. The last study visit occurred on 24 August 2018.|240 participants were screened.
723636|NCT02266381|A prospective and randomized study was performed with patient enrollment from July 2014 to May 2015 in the First Affilated Hospital of Guangzhou Medical University. 450 patients were then randomized into three groups. 12 patients had purulent fluid in the kidney at initial punctures. These 12 patients were excluded from the analysis.|549 consecutive patients were assessed for eligibility, 99 were excluded for not meeting the inclusion criteria.
723637|NCT02266277|Cycle 1 Outreach|
723638|NCT02266225||
723639|NCT02266147||
723640|NCT02266108||
723641|NCT02266004|One participant was removed from the study and re-enrolled. However, this participant did not complete the study intervention on their first or second enrollment. Therefore their data has not been included in any of the outcome measures.|
723642|NCT02265965||
723643|NCT02265952|The study was conducted at five sites in United States, Canada, and the Netherlands between 04 Feb 2015 and 23 Jul 2018. A total of 12 participants were screened in the study. Out of 12 participants, 9 participants received the study treatment.|This study consisted of 2 screening periods: 1st for main study and 2nd for open label extension (OLE) period. Participants on stable background medical lipid-modifying therapy for at least 4 weeks prior to screening, or who didn't undergo lipid apheresis within 4 weeks prior to screening visit, were directly entered into a 2-week screening period.
723644|NCT02265848|All study subjects were recruited from the Carolinas Pain Institute who were implanted with Boston Scientific's Precision Plus spinal cord stimulation (SCS) system for chronic axial pain, and at the time of recruitment, was not receiving adequate pain relief from SCS system with baseline numeric pain rating scale of 5 or greater.|Randomization scheme was 1 to 1 ratio. Randomization assignment was generated using random number generator, and individual results were sealed in an envelope. If subject needed to be replaced, the replacement subject will receive the same randomization assignment.
723645|NCT02265796|recruitment period first subject enrolled 9/24/2014 to last subject enrolled 12/12/2015|
723646|NCT02265783||
723647|NCT02265744||730 participants were enrolled and 349 were randomized. 3 were randomized but not treated.Of the 381 who were not randomized,3 had an adverse event, 16 withdrew consent, 1 was lost to follow-up, 339 did not meet study entry criteria and 22 due to other reasons.
723648|NCT02265705||"Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment (Tx) beginning at Week 16.
~Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline."
723649|NCT02265510|Participants took part in the study at 11 investigative sites in United States from 10 September 2014 to 27 February 2019. This study was prematurely terminated due to lack of efficacy.|Participants with advanced malignancies,acute myeloid leukemia(AML),high-risk myelodysplastic syndrome(MDS)who failed prior therapy with hypomethylating agents(HMA)enrolled to dose escalation(Part 1),expansion(Part 2) of INCB052793 monotherapy and combination therapy cohorts.CohortsA,C,D,E,G,H had no enrollment at the time of premature termination.
723650|NCT02265341||
723651|NCT02265237|The study was divided into 2 parts with 184 total participants. Part I (Arms A and B) included participants who received either 12 or 16 weeks of treatment and Part II (Arms C and D) included participants who received 24 weeks of treatment. Enrollment into Part II opened once randomization in Part I was completed.|Safety analysis population: all participants who received at least 1 dose of study drug. One participant randomized to the arm B (16 weeks arm) was erroneously administered study drug for 12 weeks (as in arm A). Therefore this participant is included in arm A for the safety population.
723652|NCT02264977||
723653|NCT02264821||
723654|NCT02264574|This study was conducted in 71 sites: 8 in the US, 36 in the EU, and 27 sites in 6 additional countries (Canada, Australia, New Zealand, Russia, Israel, Turkey). The first participant consented 06 October 2014. The last visit of the last participant was 03 September 2019, with a final database lock of 17 October 2019.|Eligible participants were required to have had a diagnosis of active CLL/SLL conformant to IWCLL 2008 criteria. All subjects were required to have measurable nodal disease. Key exclusion criteria included any previous CLL/SLL treatment; known lymphoma or leukemia of the central nervous system, history/current evidence of Richter's transformation.
723655|NCT02264353||
723656|NCT02264249||
723657|NCT02263911||
723658|NCT02263833||In total, 748 participants were enrolled from 27 sites, of which only 742 participants were used for safety and efficacy analysis.
723659|NCT02263547|Enrollment occurred from March 2015 through May 2016 at the USF Carol and Frank Morsani Center.|Participants were healthy individuals with no significant health history or concomitant medication use.
723660|NCT02263365||
723661|NCT02263326||
723662|NCT02263131||
723663|NCT02263118||
723664|NCT02263079|The study began as a single-site, three arm IST and was subsequently adapted as a multi-center, two arm study, conducted at 22 sites in Malaysia, Taiwan, Australia, Belgium, Germany, United Kingdom, Italy, Romania, Russian Federation, Turkey, Ukraine and the U.S. Enrolment was stopped prematurely, at which time 62 participants had been enrolled.|
723665|NCT02263040||
723666|NCT02263014|Recruitment Period: February 24, 2014 to December 31, 2015. All recruitment done at The University of Texas MD Anderson and Kelsey Seybold Clinics.|Of the 345 women enrolled some were excluded from the study, 37 were determined to be ineligible for participation (reasons included BRCA1/2 carrier, no breast surgery performed, no breast surgery at institutions, metastatic disease at diagnosis) and another 56 women did not complete the required baseline (pre-surgery) assessment.
723667|NCT02262754||
723668|NCT02262728||
723669|NCT02262507||
723670|NCT02262377||
723671|NCT02262364||
723672|NCT02262260||
723673|NCT02262130||
723674|NCT02262078|Participants were referred to the Rochester, Minnesota Mayo Clinic cardiac catheterization laboratory for invasive hemodynamic exercise stress testing between December 2014 and December 2015.|Of 70 patients screened, 32 were excluded based upon entry criteria and 12 were excluded based on hemodynamic criteria for Heart Failure with preserved Ejection Fraction (HFpEF) (n=10) or because arterial pressures were too low (n=2).
723675|NCT02262039||
723676|NCT02261974||
723829|NCT02249143||
723677|NCT02261948|From September 2012 to December 2014 we enrolled forty-two patients who fulfilled the study inclusion/ exclusion criteria:19 patients received placebo and 23 received levosimendan. All patients was enrolled at Centro Cardiologico Monzino.|Eligible patients had advanced chronic heart failure and were admitted because of worsening HF (Heart Failure),although the patients included in the study had been returned to a stable clinical condition and were free from both inotrope support and other i.v. therapies for at least 48h prior to study inclusion, except for diuretics where needed.
723678|NCT02261818||No pre-study details.
723679|NCT02261805||
723680|NCT02261714||
723681|NCT02261597||
723682|NCT02261493||Subjects were randomized to placebo, onabotulinumtoxinA Dose A, or onabotulinumtoxinA Dose B in Period 1. Subjects randomized to receive placebo or Dose B in Period 1, who subsequently continued to Period 2, received onabotulinumtoxinA Dose A in Period 2.
723683|NCT02261467|A total of 421 subjects were enrolled in the study, of these, 30 subjects were excluded from the data analyses at one site. The participant flow reflects all subjects included in the data analyses.|Subjects were randomized to either placebo or onabotulinumtoxinA in Period 1. Subjects randomized to receive placebo in Period 1 who subsequently received open-label onabotulinumtoxinA in Period 2 are also included in the onabotulinumtoxinA group for the Safety analysis.
723684|NCT02261428|All ICU patients were breathing spontaneously, had respiratory failure of various pathophysiological mechanisms, with impaired cough reflex|Of the 30 patients screened during the run-in period between May 2014 and September 2014 they received nasotracheal suction all. 10 of them required for pilot study and 20 for the main study. The pilot study was designated as a separate study and the participants was not included in this record.
723685|NCT02260986|The study was conducted in 14 countries between 16 Sep 2014 and 19 Oct 2016. A total of 957 participants were screened in the study.|Out of 957 participants, 740 participants were randomized and treated in the study. Participants were randomized in 3:1:3 ratio to receive Dupilumab 300 mg once weekly (qw) or Dupilumab 300 mg every 2 weeks (q2w) or placebo (for Dupilumab) qw.
723686|NCT02260934|Of the 59 participants screened, 43 were enrolled at 14 sites in the US from July 9, 2015 to May 22, 2017.|Prior to randomization, enrolled participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper. Participants were randomized at Week 4.
723687|NCT02260921||
723688|NCT02260882||Depending on prior history of Pneumovax™ 23 vaccination, 161 participants with a history of prior Pneumovax™ 23 vaccination were enrolled into the Revaccination group and 82 participants without a history of prior Pneumovax™ vaccination were enrolled into the Primary vaccination group.
723689|NCT02260817|Recruitment dates: 10/14 - 6/16, dosage and imaging only at Decatur Memorial Hospital in Decatur, IL.|No enrolled participants were excluded from either arm of the study prior to assignment.
723690|NCT02260791|Patients were enrolled in 109 sites in 12 countries in 3 geographical regions: North America, Europe and Rest of World. The first participant enrolled on 05 January 2015 and the last participant completed on 12 July 2016.|"Screening details:
~Patients were randomised in a 1:1 ratio to receive either FKB327 40 mg eow or Humira 40 mg eow using the following stratification factors: prior biological treatment for Rheumatoid Arthritis (RA) (yes/no) and Screening disease activity (DAS28-CRP ≤5.1/>5.1)."
723691|NCT02260648||
723692|NCT02260635||
723693|NCT02260622||
723694|NCT02260492|1526 Patients with asthma were screened at 48 clinical sites|"647 Failed screening (42%)
~239 failed because they did not have 40-85% pred FEV1
~240 failed because they were not >15% reversible with albuterol
~168 failed for other inclusion/exclusion criteria"
723695|NCT02260440||
723696|NCT02260401||
723697|NCT02260388||
723698|NCT02260180||
723699|NCT02260154||
723700|NCT02259699||
723701|NCT02259608||
723702|NCT02259582||
723703|NCT02259400|We enrolled 280 VLBW infants with RDS, delivered before 32 weeks of gestational age and with a birth weight <1500 gr, admitted in two NICUs (C. Arrigo, Children's Hospital, Alessandria, Italy and V. Buzzi, Children's Hospital, Milan, Italy) from January 2010 to December 2012.|156 Newborns were excluded from the study: 19 had exclusion criteria, 40 not requiring ventilation support, 35 requiring invasive ventilation, 62 not randomized within 2 hours from birth. 124 newborns needed NIV within 2-h from birth, were randomly allocated to receive either NSIPPV (n=62) or BiPAP (n=62).
723704|NCT02259348|Twelve participants meeting eligibility criteria were enrolled at St. Jude Children's Research Hospital between November 2014 and February 2015.|Six enrolled participants were blood donors and did not undergo transplantation.
723705|NCT02259114||
723706|NCT02259088||After eligibility confirmation, patients were randomized in a 4:1 ratio to 2 treatment arms.
723707|NCT02259010|Participants took part in the study at 4 investigative sites in the United States from 22 October 2014 to 21 October 2016. Data cutoff for the primary analysis was 27 March 2015.|Participants with a diagnosis of advanced solid tumors or lymphomas were enrolled to receive alisertib 30 mg tablets, orally along with itraconazole 200 mg, oral solution in part A followed by alisertib 50 mg, tablets in part B.
723708|NCT02258542|2133 patients entered BORA. 10 were excluded due to a GCP breach. Of remaining 2123 patients, 1926 entered from SIROCCO/CALIMA and 197 from ZONDA. 2 patients were not treated, and a total of 447 patients (348 SIROCCO/CALIMA and 99 ZONDA) were later enrolled into MELTEMI without completing the follow-up in BORA, so not in the main analyses.|953 participants from SIROCCO/CALIMA receive benralizumab 30 mg at every 4 weeks during BORA. 971 participants from SIROCCO/CALIMA receive treatment at every 8 weeks during BORA. 100 participants from ZONDA receive treatment at every 4 weeks during BORA. 97 participants from study ZONDA receive treatment at every 8 weeks during BORA.
723709|NCT02258529|Participants were enrolled at study sites in the United States. The first participant was screened on 14 September 2015. The last study visit occurred on 03 May 2016.|20 participants were screened.
723710|NCT02258477|Subjects were recruited using study flyers and the study was posted on the Center website.|Note, that each subject participated in the study for four weeks, consuming a different study beverage daily for one week, being crossed-over to another beverage the following week. Thus a total of 33 subjects completed all four weeks of the cross-over study.
723711|NCT02258464|151 participants were screened at 69 active centers in 20 countries, the first participant first visit was on 02 Mar 2015 and last participant last visit was on 13 Aug 2019|Of the 151 screened participants, 99 participants (65.6%) completed screening and were assigned to treatment: 49 in the radium 223 dichloride and 50 in the placebo arm
723712|NCT02258412|Recruitment took place from October 2014-January 2015 at 3 MICUs within the same hospital|Subjects were enrolled on the same day as treatment; subjects were required to meet inclusion/exclusion criteria to qualify for enrollment
723713|NCT02258373||
723714|NCT02258334|Study participants were enrolled from 01 October 2014 to 07 November 2014 at 4 clinical sites in the United States.|A total of 208 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in this study.
723715|NCT02258256||
723716|NCT02258217||
723717|NCT02258152|This study was conducted in 18 study centers in the US. Combined, a total of 82 patients were randomized: 44 patients to treatment with placebo and 38 to treatment with SYN120, 100 mg QD (once a day). Of these patients, 72 (88%) completed the study.|
723718|NCT02258139||
723719|NCT02257970|Part 1 was feasibility, exploratory, open-label ketoprofen, to document effects. Part 2 was open-label trial of ketoprofen to document histological response. Part 3 was double-blind randomized to receive placebo or ketoprofen to evaluate safety and efficacy.|
723720|NCT02257918|Untreated participants with signs and symptoms of urethral or cervical gonorrhea, or confirmed urethral or cervical gonorrhea as defined by positive culture, NAAT test, or Gram-stain or any type of sexual contact in the past 14 days with an infected individual were enrolled between 25NOV2014 and 02DEC2015.|
723721|NCT02257684||
723722|NCT02257632|The study included adult patients with active, newly diagnosed, and untreated wAMD. A total of 40 patients were treated at 6 study sites across Germany. Patients were treated in an outpatient setting.|"At Screening, the eligibility criteria were performed.
~."
723723|NCT02257541||
723724|NCT02257528|This study was activated on 5/18/2015 and closed to accrual on 6/8/2016.|
723725|NCT02257489||
723726|NCT02257385|Eligible participants (par) completed a 5-7 day run-in period, and were randomized to blinded study medication for 12 weeks. Supplemental albuterol/salbutamol was provided to all par, to be used on an as-needed basis during run-in and up to Day 85.|A total of 1190 par were screened; 967 par randomized and 961 par comprised the Intent-to-Treat (ITT) Population (Pop), comprised of all par randomized to treatment (trt) who received at least 1 dose of randomized study medication in the trt period.
723727|NCT02257372|Participants had used one of the following inhaled corticosteroids (ICS)/long-acting beta2-agonist (LABA) combinations for at least 30 days prior to Screening: Fluticasone Propionate/Salmeterol (FSC) 500/50 microgram (mcg) twice-daily (bid); budesonide/formoterol 200/6 mcg bid or 400/12 mcg bid; ICS/LABA combinations per study procedures manual.|Participants who met eligibility criteria at screening completed an approximately one week run-in period and participants who met the randomisation criteria were entered a 12-week treatment period. A total of 266 participants with chronic obstructive pulmonary disease (COPD) were screened; 236 participants randomized and entered into the study.
723728|NCT02257099||
723729|NCT02256982|A total of 3 patients were enrolled between November 2014 and July 2015.|
723730|NCT02256969||
723731|NCT02256917||
723732|NCT02256891||
723733|NCT02256839||For the TB low risk cohort, 2 samples were excluded due to sample transport issues and the third sample for being misdiagnosed as low risk. For the non-TB cohort,1 sample was excluded due to a sample transport issue, and second excluded sample was inadvertently enrolled twice.
723734|NCT02256553||
723735|NCT02256540|Healthy women ages 50-70 years, at least 1 year beyond menopause and free of overt cardiovascular or chronic diseases.|7 participants did not qualify to participate in the study after consent/enrollment.
723736|NCT02256488|Subjects were enrolled at Twenty five study centers in the United States of America.|All enrolled subjects were included in the trial.
723737|NCT02256436||This interim analysis of the results disclosure is based on data collected prior to the database cutoff date of 07-Sep-2016 (up to approximately 20 months of follow up from study start), at which time, 175 participants were ongoing in the study.
723738|NCT02256384|Whenever possible, the family will be approached at a pre-surgical clinic visit or contacted by phone the day before recruitment to explain the study. Consent will occur in person at either a clinic visit prior to the day of surgery, in the pre-operative area on the day of surgery, or in the patient's room after surgery.|
723739|NCT02256358||
723740|NCT02256345||
723741|NCT02256267||This is an open-label, 2-period, fixed-sequence study
723742|NCT02256189||
723743|NCT02256111||
723744|NCT02256072|Recruitment for this study took place between October 1, 2014 and September 30, 2015.|Enrolled participants were excluded from the trial before assignment to groups if they did not reach randomization (e.g. they did not reach ). All participants reached randomization.
723745|NCT02255981|Project was announced to ophthalmologists asking them to refer patients. Very few arrived by reference and most entered by personal interest. Study was conducted in Medical consultation site of Neijing School, in Medellín, Colombia The recruitment period was between April 2013 and May 2014.|35 patients were eligible, 2 refused to participate, 29 completed follow up. There was not an assignment, all received the same treatment although the diagnostics comprised different forms of macular damage it was pre-specified to analyze them as a single group for the Outcomes 2 eyes were excluded: 1 blind and 1 with retinal detachment.
723746|NCT02255760||A total of 131 participants were screened, of which 75 did not meet eligibility criteria and were considered as screen failures; and the remaining 56 participants were randomized into the study.
723747|NCT02255565|Eligible participants were recruited from the investigators' practices, clinic referrals, and letter mailings. Participants were enrolled between September 2014 and September 2016.|Of the 36 participants enrolled, 27 were randomized to receive treatment. 3 participants withdrew, 2 due to time commitment issues and 1 due to stress over screening. 6 participants were deemed ineligible for the study due to no Autism Spectrum Disorder (ASD) diagnosis based on screening assessments.
723830|NCT02249104|First subject, first visit: 20 Aug 2014; Single center study|
723831|NCT02249065||
723750|NCT02255461|Patients between 4 and 21 years of age with histologically confirmed retinoblastoma protein (Rb1) positive, primary recurrent, progressive, or refractory central nervous system tumors were enrolled at Pediatric Brain Tumor Consortium member institutions. The first patient was enrolled on 12/8/2014 and the last patient was enrolled on 10/10/2018.|All 35 eligible patients enrolled were included. The 'Completed' row included patients who completed all protocol therapy or who experienced a protocol endpoint which took them off therapy. These included dose limiting toxicities and progression/relapse events. Adverse events not related to study agent were included in the 'Not Completed' row.
723751|NCT02255422|First patient enrolled 5-May-2015, last patient completed 30-Nov-2017|
723752|NCT02255357||
723753|NCT02255279|Subjects were enrolled from 3 study centers in Mexico.|All enrolled subjects were included in study.
723754|NCT02255175|The recruitment process included, social media advertising using Facebook, Instagram, and Craigslist; mass emailing using university wide emails and a database of select University of North Carolina (UNC) healthcare patients (Carolina data warehouse); and flyer advertisements placed in university buildings and local businesses.|Enrolled participants were excluded prior to the start of study intervention due to: exclusionary psychiatric history (i.e. substance abuse, past hypomania, persistent depression), exclusionary gynecological history (i.e. fibroids, abnormal pap), exclusionary medical history (i.e. abnormal lab values), exclusionary medication, and imaging concerns.
723755|NCT02255149||
723756|NCT02255110|First/Last subject (informed consent): 10 December 2014/02 November 2015. Study completion date: 12 January 2016. Clinical data cut-off: 31 March 2016.|The study was planned to include a combination therapy period (including an initial Safety Run-In Phase followed by Phase II treatment period) and a TH-302 monotherapy period. However, due to early termination, only Safety Run-In Phase was conducted; thus, all the analyses are limited to Safety Run-In Phase.
723757|NCT02255097|The study enrolled participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, and larynx who have progressed on platinum and cetuximab therapy. Other inclusion and exclusion criteria applied.|The data cut-off date for this results disclosure was 22-Apr-2016. 172 participants were allocated and 1 participant was not treated so is excluded from safety and efficacy analyses. 36 participants still receiving treatment at data cut-off date.
723758|NCT02254772||
723759|NCT02254681|6 subjects recruited from 9/2014-12/2015|
723760|NCT02254551|The primary objective of this study was to investigate safety, tolerability and determine the maximum tolerated dose (MTD) of LDE225 to administer along with a fixed dose of bortezomib. Between March 2015 and September 2015, 7 patients were enrolled in the safety lead-in part of the study at 4 investigational sites in the U.S.|7 patients received at least 1 cycle (21 days) of treatment on dose level 1.
723761|NCT02254486|The trial recruited out/in-patients at 12 medical centres in the USA, from September 2014 to May 2015.|
723762|NCT02254473||
723763|NCT02254460|Participants were recruited from two centers in India.|A total of 37 participants were screened, 25 were randomized and 24 completed the study. One participant withdrew from the study due to an adverse event (AE).
723764|NCT02254421|Participants were enrolled at study sites in Asia Pacific, Europe, and the United States. The first participant was screened on 31 January 2015. The last study visit occurred on 17 April 2017.|71 participants were screened.
723765|NCT02254408|Participants were enrolled at study centers in North America, Europe, Australia and Asia. The first participant was screened on 23 January 2015 and the last study visit occurred on 14 July 2017.|213 participants were screened.
723766|NCT02254304|The study was conducted at 7 sites in Romania.|
723767|NCT02254291|The trial was conducted at 25 sites in Japan. These sites randomised/assigned subjects to treatment.|Subjects were either on stable diet and exercise therapy only or on stable oral anti-diabetic drug (OAD) monotherapy (a maximum dose of 750 mg metformin or 2250 mg METGLUCO according to approved Japanese labelling) in addition to stable diet and exercise therapy for at least 30 days prior to screening (week -8 or week -2).
723768|NCT02254278||After first step registration and prior to randomization, patients were tested for p16. Only patients with p16-positive tumors continued on to randomization. In total, 316 patients were enrolled and 308 were randomized.
723769|NCT02254265||
723770|NCT02254252||
723771|NCT02253992||160 enrolled and treated
723772|NCT02253654|This study was conducted at 31 centers in the United States. Participants were enrolled from 01 April 2015 to 17 August 2015.|Eligible participants with anemia and chronic kidney disease who were receiving hemodialysis were randomized in a 1:1 ratio to 1 of 2 dosing algorithms.
723773|NCT02253537||
723774|NCT02253433||
723775|NCT02253394||
723776|NCT02253173||
723777|NCT02253160|Subjects were recruited from the specialized donor population of blood centers from August 2014 through January 2015.|A lead-in phase was used to allow for investigational device training. One subject consented the lead-in phase and was included in the safety analysis only. After a screening period to evaluate and confirm eligibility criteria prior to enrollment & randomization to treatment assignment (Arm 1 or Arm 2) 22 subjects enrolled in the pivotal study.
723778|NCT02253147|"A total of 120 were randomized for a split-face injection of RHA Ultra Deep and Perlane-L.
~20 subjects were randomized to an untreated group (recruited only to avoid Blinded Live Evaluator to be biased so, not presented)"|2 subjects randomized to the RHA UD/Perlane discontinued participation prior to receiving study treatment (N=118) 2 subjects randomized to the untreated group received injections with RHA UD/Perlane. These subjects were placed in the SAFT population for safety evaluations (SAFT population n=120)
723779|NCT02252965||
723780|NCT02252939||
723781|NCT02252744||
723782|NCT02252718|This study was conducted at the Department of Paediatrics of the Medical University of Warsaw between September 2014 and February 2015.|
723783|NCT02252666||
723784|NCT02252588||
723832|NCT02249052|Subjects were screened and enrolled at two study sites in the United States.|Subjects must present with 2 lipomas meeting inclusion criteria
723833|NCT02248974||We enrolled a total of 98 participants. This number is consistent between the Protocol Section and the Participant Flow Module.
728206|NCT01921387||
728207|NCT01921348||
723785|NCT02252562|Operating room enrollment occurred from September 30, 2013, to June 17, 2014, at Dartmouth-Hitchcock Medical Center and from January 8, 2014, to August 21, 2014, at UMass Memorial Medical Center. Five to 10 operating rooms were enrolled Monday-Friday for each of 20 working days per month at each site.|The randomization unit was the operating room (OR); not the patient or provider. Clinicians were educated on the purpose of the study and utilized standard practice or hand hygiene device based on the ORs. 316 clinicians utilizing the personal hand hygiene device were followed for assessment, but not enrolled.
723786|NCT02252536|The study was a Phase 2, randomized, double-blind, placebo controlled, parallel-group 26-week treatment clinical trial. Candidates responded by telephone to advertisements at 10 academic sites in the US between June 2015 and February 2017.|
723787|NCT02252445||
723788|NCT02252406|Recruitment period: 7/21/14 - 7/2/18 Location: UF Jacksonville Outpatient Cardiology clinic|
723789|NCT02252354|Participants took part in the study at 1 investigative site in United Kingdom from 29 September 2014 to 27 October 2014.|Healthy cohort of male participants were enrolled in this 2 part study, in 1 of 2 treatment groups as follows : Part 1: [14C]-TAK-385 80 milligram (mg); Part 2:TAK-385 80 mg + [14C]-TAK-385 80 microgram (mcg)
723790|NCT02252211||
723791|NCT02252172||
723792|NCT02252146||
723793|NCT02252133|Subjects were recruited from 3 study centers located in Japan.|Of the 53 enrolled, 6 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (47).
723794|NCT02252068||In the randomized controlled trial, 6 participants completed a baseline assessment but dropped out prior to randomization.
723795|NCT02252042||This results disclosure is based on a data cutoff date of 15 May 2017, at which time 99 participants were ongoing in the study.
723796|NCT02252016|Adult participants with hepatitis C virus (HCV) genotypes (GT)1, GT4, and GT6 with inherited blood disorders and with or without human immunodeficiency virus (HIV) co-infection were recruited at study centers around the world.|
723797|NCT02251990|For Subject Disposition, Period 1 covers Day 1 through Week 12 for both treatment groups. Period 2 covers Week 12 through Week 36 for the Immediate Treatment Group (ITG) and Week 12 through Week 28 for the Deferred Treatment Group (DTG). Period 3 covers Week 28 through Week 52 for the DTG; the ITG completed the study with Period 2.|A total of 489 participants were randomized to treatment, and 488 participants received ≥1 dose of study drug during the blinded period. One participant randomized to the ITG withdrew consent after randomization, but prior to receiving study drug.
723798|NCT02251938||
723799|NCT02251912||
723800|NCT02251886||
723801|NCT02251743||Of 329 children screened, 305 passed categorical and parent-rated dimensional criteria for ADHD. Of these, 235 passed the TBR screen. Of the149 completely eligible,144 were randomized, and of the 144, 2 withdrew consent for logistical reasons before any post-treatment assessment. Thus,142 subjects comprised the population for the primary analysis.
723802|NCT02251717|Participants were enrolled at study sites in Europe. The first participant was screened on 14 October 2014. The last study visit occurred on 16 June 2016.|130 participants were screened.
723803|NCT02251652|Subjects were recruited from the Faculty Practice and resident clinics at Mount Sinai. Seventeen subjects were enrolled in the study; one subject withdrew consent prior to treatment.|
723804|NCT02251613|Participants were recruited from 1 study site located in Japan.|All subjects qualifying for treatment at Visit 3 were randomized. This reporting group includes all randomized participants (50).
723805|NCT02251561|Subjects were enrolled from one study site located in Japan.|Of the 36 subjects enrolled in the study, 8 were exited prior to product exposure [did not meet eligibility criteria (5), and subject withdrawal (3)]. This reporting group includes all subjects who used the study products (28).
723806|NCT02251548|The study opened to enrollment on 10/3/2014 and closed to enrollment on 4/24/2018. 58 participants were enrolled at Dana-Farber, 9 at Massachusetts General Hospital, 3 at Beth Israel Deaconess Medical Center, 9 at Duke University, 1 at University of Kansas, 3 at West Michigan Cancer Center, and 2 at University of Miami for a total of 85 enrolled.|
723807|NCT02251379||
723808|NCT02251275|Eligible participants could enroll into Trial 156-13-211 after completing follow-up visit(s) of their previous trial (156-13-210, 156-08-271, 156-04-251, or 156-09-290).|"One participant screened, but withdrew consent on the same day (prior to study drug treatment) and is not included in the study data.
~Starting doses depended on the participant's previous trial."
723809|NCT02251236||
723810|NCT02250807||
723811|NCT02250703||
723812|NCT02250612||
723813|NCT02250521||
723814|NCT02250443|Due to lack of efficacy in patients with sIBM, the study was terminated early.|
723815|NCT02250417||
723816|NCT02250326|This was a multicenter study with 34 sites from the United States, Canada, France, Germany, Italy, Spain and the United Kingdom.|Eligible participants included those with advanced non-small cell lung cancer who had received no more than one prior containing chemotherapy regimen. Immunotherapy as a prior line of treatment was allowed. Randomization was stratified by eastern cooperative oncology group performance status, gender and the smoking status of the participant.
723817|NCT02250274||
723818|NCT02250183|Participants were recruited largely from an outpatient burn care clinic in a hospital in the Northeastern U.S.. Some participants also were recruited during their hospitalization in the hospital's inpatient burn care center. The first participant was enrolled on 03/15/2014; the final participant was enrolled on 08/11/2016.|
723819|NCT02250092||
723820|NCT02249949||A protocol amendment (Update #02) removed the option for patients to be randomized to Placebo; the study went from being a randomized study to a single arm study. The discrepancy in the number of patients who 'Started' the study and the Protocol Enrollment number is due to there being 2 patients randomized to Placebo prior to Update #02.
723821|NCT02249832||All participants received eighteen sessions of seated anklebot training. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning.
723822|NCT02249819||All participants received both the active and sham tDCS conditions, and sequence of stimulation conditions was randomized across participants.
723834|NCT02248961|Participants recruitment was conducted in 13 clinical sites of Moscow and Saint-Petersburg between May and October of 2014|Duration of screening period was up to 14 days depended on prior antihypertensive treatment. 184 patients were screened, 179 randomized.
723835|NCT02248922|"At least 35 patients were planned to be recruited in the study. However, in total, 17 patients entered into the study and completed.
~Reason for termination was challenge with enrollment and recruitment. A significant decrease in the eligible patient population was main driver."|
723836|NCT02248857||
723837|NCT02248818|Healthy Adult volunteer study, Part 1: SAD: single ascending dose cohorts, followed by Part 2: MAD: multiple ascending dose cohorts. Plan was for each cohort to have 8 subjects, 2 placebo dosed and 6 AZD8108 dosed.|Protocol allowed for 258 subjects to be screened, only 155 subjects were screened before all cohorts for the study were filled and recruitment ended.
723838|NCT02248766||
723839|NCT02248740||
723840|NCT02248727||
723841|NCT02248714||
723842|NCT02248675|581 potential participants were identified from medical records and received a recruitment letter from their current treatment provider; 420 were reachable and screened by phone with 71 meeting initial eligibility criteria, completing written informed consent and baseline interview. 54 participants met all eligibility criteria and were randomized.|
723843|NCT02248662|The computer model included data from sources including the NSABP B-17 and B-24 trials; the UK, Australia, and New Zealand ductal carcinoma in situ (DCIS) trial; an observational study of newly diagnosed patients with DCIS treated in British Columbia; and SEER databases. The researchers also conducted two retrospective studies.|Originally, 38,514 total records from each database used for this study were screened for enrollment into the final cohort. After eligibility criteria were applied to the sample, the final sample size was 3,436.
723844|NCT02248649||
723845|NCT02248636|Veterans who have received a prescription for a cholinesterase inhibitor for one year or greater.|72 people were enrolled and consented, but only 61 were randomized.
723846|NCT02248558||
723847|NCT02248480||All started participants (pt) were randomized and received at least one dose of study drug. Efficacy population had at least 1 post-dose efficacy assessment.
723848|NCT02248285||
723849|NCT02248246||
723850|NCT02248103||
723851|NCT02247960||
723852|NCT02247804||
723853|NCT02247765||
723854|NCT02247739||
723855|NCT02247531|A total of 975 participants were randomized to the study at 144 study sites across 22 countries. The study was terminated early by the Sponsor due to lack of efficacy.|This study enrolled participants with bilateral Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) and no signs of prior or active choroidal neovascularization (CNV), age >= 50 years with a valid complement factor I (CFI)-profile biomarker result.
723856|NCT02247479|A total of 906 participants were randomized to the study from 131 investigation sites across 19 countries. The study was terminated early by the Sponsor due to lack of efficacy.|This study enrolled participants with bilateral Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) and no signs of prior or active choroidal neovascularization (CNV), age >= 50 years with a valid complement factor I (CFI)-profile biomarker result.
723857|NCT02247466||
723858|NCT02247440||
723859|NCT02247401|Safety population: All participants who received at least one dose of study drug.|
723860|NCT02247245||The predicted group size to demonstrate a clinically important change was revised after post hoc analysis of pilot data demonstrating higher pVO2 values for both SR and AF than expected (minimum requirements:12 subjects in AF group, 20 in SR group). To allow for dropouts, recruitment targets were altered 14 with AF and 26 with SR (total 40).
723861|NCT02247063||
723862|NCT02247011|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013.|All participants who agreed to be re-evaluated were enrolled in this study.
723863|NCT02246998|Participants were enrolled at study sites in Belgium, Ireland, Spain, and the United Kingdom. The first participant was screened on 15 Dec 2014. The last study visit occurred on 17 February 2016.|93 participants were screened.
723864|NCT02246777|Subjects were recruited from 3 study centers located in Japan.|
723865|NCT02246764||
723866|NCT02246673|Sixty-four subjects were randomized and received at least 1 dose of randomized study medication. Five cohorts of approximately 12 adult subjects with gout per cohort were randomized into the study. Overall, a total of 60 subjects completed the study in accordance with the protocol.|Cohorts 1 through 4 were conducted sequentially and Cohort 5 was conducted following review of the available PD/PK results of Cohort 2. Subjects in Cohorts 1 through 4 were randomized to 1 of 2 treatment sequences (ABCD or DCBA) in a 1:1 ration and subjects in Cohort 5 were randomized to 1 of 2 treatment sequences (EHGF or GFHE) in a 1:1 ratio.
723867|NCT02246660||
723868|NCT02246647||
723869|NCT02246621||Completers are participants who died.
723870|NCT02246608||
723871|NCT02246582||118 subjects consented and enrolled in the overall study. Of the 118, 89 subjects utilized the latest sensor version.
723872|NCT02246439|"First patient randomized: 08 December 2014 Last patient completed: 17 February 2017
~This study was conducted in Emergency Departments (EDs) and urgent care centers across the United States. Only 2 sites were urgent care centers; the rest were EDs."|
723873|NCT02246413||
723874|NCT02246309|This study was completed during 3.5 months between December 2014 and March 2015, the time period our center (Center for Human Reproduction in New York City).|134 patients were offered participation during the study period. Ten were excluded because they were using embryo banking. Eighty five declined participation leaving only 49 qualified and/or consented to participate.
723875|NCT02246218||A total of 27 participants were enrolled; 1 participant was not dosed and is not included in any analysis.
723876|NCT02246166|The participants were recruited at 2 clinical sites in China|
723877|NCT02246114||
723878|NCT02246062||
723879|NCT02246010||
723880|NCT02245737||
723929|NCT02241187|Protocol Open to Accrual 09/12/2014 Protocol Closed to Accrual N/A Primary Completion Date 09/13/2016 Recruitment Location is the medical clinic|
723881|NCT02245620||2 subjects discontinued prematurely as per Investigator's discretion. These 2 subjects (Subject 001019 [Elamipretide group] and Subject 001063 [Placebo group]) were discontinued after randomization but prior to receiving study treatment; both were not treated due to their pre-infusion sodium levels meeting Exclusion Criteria 6.
723882|NCT02245568||Subjects who completed a Phase 2 or 3 study of LMTM were eligible to enroll, pending their ability to meet the inclusion/exclusion criteria. A total of 913 subjects enrolled; however, data for 16 subjects in Spain were later excluded (GCP issues) and 1 UK subject was never dosed. Thus, 896 subjects are included in all analyses except disposition.
723883|NCT02245516||
723884|NCT02245412|This study enrolled participants with newly diagnosed acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.|
723885|NCT02245360||
723886|NCT02245308||Five participants who signed consent were ineligible to participate in the study because they didn't meet basic eligibility criteria. One participant who signed consent was not randomized to treatment because he was unwilling to stop marijuana use prior to participating.
723887|NCT02245217||
723888|NCT02244996|Recruited from a retinal disease patient association, Retina Hong Kong, and the Optometry Clinic at The Hong Kong Polytechnic University|All the eligible subjects had the eye examination, including VA (ETDRS) charts, refractions, tonometry, external and internal ocular health assessments, fundus photo-documentation, Ganzfeld Electroretinogram, Humphrey Visual Field Analyser and Spectral-domain Optical Coherent Tomography
723889|NCT02244957||
723890|NCT02244944||
723891|NCT02244918||
723892|NCT02244840||
723893|NCT02244619||
723894|NCT02244580|The clinical data and breast tumour tissue samples were collected within the FinHer trial (identifier ISRCTN76560285), where 1010 women with axillary node-positive or high-risk axillary node-negative breast cancer were randomly assigned between October 2000 and September 2003.|
723895|NCT02244424|Teen mothers of infants were recruited. Teen mothers participated in the intervention. Infants were included for collection of demographic and weight data. Thus the actual number of participants is doubled to account for both the mothers and infants as participants. Protocol Enrollment number then is 164 ( 82 teen mothers and 82 infants).|
723896|NCT02243943||
723897|NCT02243696||
723898|NCT02243605||
723899|NCT02243579||
723900|NCT02243527||
723901|NCT02243371||
723902|NCT02243306|This repeat-dose, pharmacokinetic (PK) study of GSK1278863 was conducted at two centers in the United States (US). Participants with End Stage Renal Disease (ESRD) undergoing continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) were included in this study.|A total of 20 participants with ESRD were screened; of which 12 were screen failures and 8 entered the study to receive 5 milligrams (mg) of GSK1278863 once daily for 14 days.
723903|NCT02243293|Enrollment into arms H, I, K, M and N was not opened by AbbVie.|Intent-to-treat population: all participants who received at least 1 dose of study drug
723904|NCT02243280||Safety population: all participants who received at least 1 dose of study drug. Two participants assigned to Arm I received the incorrect dose of study drug throughout their participation in the study (ABT-493 200 mg QD instead of 300 mg) and are therefore included in Arm A instead of Arm I in the safety population.
723905|NCT02243202||Between screening and randomisation, eligible subjects were included in a 4-week single-blind run-in period in which all subjects were placed on a hypocaloric diet.
723906|NCT02243176|A total of 689 patients were enrolled into this study from 35 sites in China. The enrolled patient number ranged from 10 to 58 among 24 centers, and 2 to 9 patients from eight centers, none was enrolled in 3 centers. The enrolment period was from 24 Sep 2014 to 29 Sep 2015.|A total of 201 patients were enrolled but not randomized: 171 patients did not meet eligibility criteria, and 24 patients were voluntary discontinuations, two patients developed study-specific withdrawal criteria, one patient lost follow-up, and three patient failed due to other reasons
723907|NCT02243046||
723908|NCT02243020|Recruitment was from January 2016 through August 2017 at 3 US and 1 UK sites.|
723909|NCT02243007||
723910|NCT02242994||
723911|NCT02242981||
723912|NCT02242942||
723913|NCT02242903||
723914|NCT02242643|Primed subjects:Received atleast 2 doses of seasonal influenza vaccine since 1 July 2010 or atleast 1 dose of the 2013-2014 seasonal influenza vaccine. Unprimed subjects:Did not receive any seasonal influenza vaccine or received only 1 dose of seasonal influenza vaccine since 1 July 2010, but did not receive any 2013-2014 seasonal influenza vaccine|"Data has been analyzed in sub-groups by age: 6-17 months and 18-35 months and by priming status.
~6 subjects were allocated subject numbers but did not receive the study vaccine dose and for 2 subjects the blood samples were withdrawn but they did not participate in the study due to screening failure."
723915|NCT02242630|Subjects for this study were recruited from the internal medicine (IM) clinic or IM subspecialties clinic from our academic community hospital between September 2014 and December 2015. Subjects had to satisfy the inclusion criteria and have none of the exclusion criteria.|There was no wash out, run-in, or transitions in this trial.
723916|NCT02242487||Safety population - Altogether, 325 patients were randomized and 312 patients received at least 1 dose of study drug and were included in the Safety Population. Thirteen patients were randomized but did not receive study drug.
723917|NCT02242305||
723918|NCT02242201||
723919|NCT02242019||
723920|NCT02241889||
723921|NCT02241785||
723922|NCT02241733||
723923|NCT02241720||
723924|NCT02241655||1400 participants were consented to the study168 were not randomized to a study treatment arm (2 died, 49 were ineligible after enrollment, 49 surgery was cancelled, 31 research team missed the surgery, 37 withdrew). A total of 1232 patients were randomized to a study arm.
723925|NCT02241551||
723926|NCT02241512||10 patients excluded after enrollment. 5 did not undergo ERCP and thus did not receive a study drug. 3 did not have study drug available in time for procedure. 2 did not meet inclusion criteria.
723927|NCT02241486||There are no pre-assignment details.
723928|NCT02241343||
723930|NCT02240810|"PLATINUM Diversity and PROMUS Element Plus US Post Approval study (PE Plus) are two separate studies that have been pooled.
~Only the PLATINUM Diversity subjects (n=1501) are considered to be enrolled in the study. Results for the PROMUS Element Plus study are reported in record NCT01589978"|
723931|NCT02240706|This is a phase I/II, multicenter, open-label, dose escalation and randomized trial of BI 836858 in patients with low or intermediate-1 risk myelodysplastic syndromes.|Subjects were screened for eligibility prior to participation. They attended a specialist site which ensured that they strictly met all eligibility criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
723932|NCT02240693|A multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer's Disease|For this trial, patients were randomised at 36 sites in 11 countries. Following an initial Screening Visit and a single blinded 2-week placebo run-in period, patients who qualified according to the in- and exclusion criteria were randomised to one of the five treatment groups
723933|NCT02240680|This was randomised, double blinded, placebo controlled, parallel study. Total 525 patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control were screened. 302 patients were randomised into two groups. The trial was extended to 52 weeks for Japanese patients. 102 patients were identified and observed for the extended period.|All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
723934|NCT02240667|In this study 1506 patients were entered, 1421 patients had at least one documented prescription of dabigatran etexilate (DE) or vitamin K antagonists (VKA)and were analyzed in the Treated set. 952 patients were matched 1:1 based on Propensity Score (PS).|The patients were enrolled from 1000 sites from Germany. Approximately 2/3 (about 670) will be community-based primary care internists/general practitioners and approximately 1/3 (about 330) community-based cardiologists across Germany.
723935|NCT02240654|This was a descriptive, observational, non-interventional (NIS) multinational, European cross-sectional study with sources of information for clinical conditions available being highly variable across countries/data sources|Because it is not possible to rule out duplicate patients across the 2 French panels, all numbers were calculated stratified by data source, and for France further stratified by panel - i.e., not overall.
723936|NCT02240628||
723937|NCT02240589||
723938|NCT02240368||
723939|NCT02240329||
723940|NCT02240186||
723941|NCT02240121|A total of 80 participants were enrolled and randomized in this study.|Participants were randomized in a 1:1 allocation to Rifaximin EIR 800 mg or Placebo at the beginning of the treatment period and were maintained on that treatment assignment for 16 weeks, followed by an open-label long-term active treatment extension of an additional 36 weeks.
723942|NCT02240108|A total of 81 participants were enrolled and randomized in this study.|Participants were randomized in a 1:1 allocation to Rifaximin EIR 800 mg or Placebo at the beginning of the treatment period and were maintained on that treatment assignment for 16 weeks, followed by an open-label long-term active treatment extension of an additional 36 weeks.
723943|NCT02240030||
723944|NCT02239978|A total of 42 individuals were enrolled in the study (30 people with Parkinson's disease and 12 healthy older adults)|
723945|NCT02239939||
723946|NCT02239926|Subjects were enrolled at Mayo Clinic, Rochester Minnesota.|"2 subjects were screen failures and were not randomized.
~1 subject signed informed consent, but the study was suspended prior to that subject's randomization."
723947|NCT02239770||In-person screening procedures included a review of medications and medical history, an assessment of drug use, a blood pressure measurement, a urine pregnancy test (if applicable), and an exhaled CO measurement to confirm prior 16 hour smoking abstinence. Those who did not satisfy inclusion criteria were excluded prior to randomization.
723948|NCT02239744|We recruited 35 healthy college students.|We recruited 35 healthy college students and no one were excluded according to the exclusion criteria.
723949|NCT02239692|Subjects were recruited from 11 sites in Germany, France and the Netherlands from Nov 2014 to Jun 2015.|
723950|NCT02239679||
723951|NCT02239640||
723952|NCT02239601||
723953|NCT02239562|sPIF (0.1, 0.5, or 1.0 mg/kg) given single SQ for 5 consecutive days. In SAD, n=18 randomized in a 2:1 sPIF/placebo ratio. 9 patients normal liver function and 9 abnormal liver function. In MAD, n=18 randomized in a 2:1 sPIF/placebo ratio. 9 patients normal liver function and 9 abnormal liver function. N=36 completed the study. total screened 36|
723954|NCT02239536|Patients were excluded if they have (1) a bleeding tendency or ever taken antiplatelet or anticoagulation therapy within 1 week before undergoing the procedure, (2) An inflammatory bowel disease, (3) a polyposis syndrome, or (4) an inability to provide informed consent.|
723955|NCT02239510|Patients enrolled from November 2014 to June 2015. A total of 16 patients were screened and 9 patients were enrolled. 3 patients did not show up to appointments and did not complete the study; 6 patients completed the study.|1 week wash-out period after enrollment
723956|NCT02239380||
723957|NCT02239328|Subjects were screened and recruited in the Thoracic surgery clinic during their appointments. Subject recruitment began on 08/20/2014 and was completed on 11/20/2015.|There was no wash out or run-in period for this study. Subjects were consented and then immediately completed the survey.
723958|NCT02239289||
723959|NCT02239120|This was randomised, active comparator, double-blind, 2 arms (1:1 ratio) event-driven Phase III trial in participants with embolic stroke of undetermined source (ESUS). Study was conducted at multiple centers in 42 countries between 3 Dec 2014 (first participant enrollment) and 14 August 2018 (last participant visit).|All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensured that all participants met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
723960|NCT02239094||
723961|NCT02238977||
723962|NCT02238925||
723963|NCT02238847||
728208|NCT01921322||
728209|NCT01921296||
723965|NCT02238483|This was a multi-centre study conducted at 39 study centres in 6 countries: Argentina (37.7% of the patients); United States (34.4%) Peru (9%) Chile (6.6%) The Netherlands (6.1%) and South Africa (6.1%) A seasonal recruitment strategy was undertaken where patients were recruited in the fall and winter months of the geographic locality.|327 patients signed informed consent, of which 213 patients were randomised. The majority of the 114 not randomised were screening failures
723966|NCT02238379||
723967|NCT02238080||
723968|NCT02238067||
723969|NCT02238028||
723970|NCT02237989||
723971|NCT02237950||
723972|NCT02237911|Potential subjects were identified from their surgeons' office or via public announcement in the greater Pittsburgh area, from December 2014 through February 2017. If interested in the study, subjects called the research team to obtain more information about the study, and were then screened for study eligibility.|A total of 1372 subjects called for study information: 89 could not be contacted and 1283 were screened over the telephone. From those, 1032 were not eligible/willing to participate and 251 completed in-person screening. Eleven subjects failed in-person screening, resulting in 240 eligible subjects that were randomized into one of the study arms.
723973|NCT02237898||
723974|NCT02237196|Participants ages 18 years to 65 years with a history of moderate to severe allergic rhinitis caused by cat exposure were recruited from 9 clinical centers in the United States from March 3, 2015 to March 21, 2017.|
723975|NCT02237118||
723976|NCT02237092|Gestational age 36 - 40 weeks, Singleton pregnancies, Elective caesarean section|
723977|NCT02237001|Subjects enrolled at clinics from 19NOV2014 until 08NOV2017; last subject visit was 18NOV2019|The planned sample size of 30 subjects was accrued for the Safety Population (SAF); however, a total of 4 subjects were excluded to comprise the Analysis Population (AS) due to late screen failure (eligibility criteria) or withdrawal by the subject.
723978|NCT02236767||
723979|NCT02236611|A total of 1290 par. were screened; 1037 par. were randomized and 1034 were in the ITT population which comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Two par. were randomized in error and one par. was randomized, but did not take any study medication.|Participants, with clinical history of chronic obstructive pulmonary disease, who meet the eligibility criteria at screening were enrolled in a 7 to 14 day run-in period. Participant meeting continuation criteria, during run-in period, were randomized (1:1) to receive umeclidinium or glycopyrronium.
723980|NCT02236598||61 participants (17%) expressed interested in the study and signed informed consent. Of these, 29 participants were deemed eligible based on the results of the screening labs
723981|NCT02236559||24 patients randomized but not enrolled were excluded for meeting exclusion criteria (10), consent not obtained or withdrawn (6), bedside clinician not comfortable with enrollment after randomization (2), & patient identified to not need NiPPV after initial evaluation, thus failing to meet inclusion criteria (6). One patient met multiple criteria.
723982|NCT02236546|Participants were recruited to this trial at Vanderbilt Medical Center in Nashville, TN from November 2014 to November 2015|Four people consented to participate in this trial, one was determined to be ineligible.
723983|NCT02236520||
723984|NCT02236338||
723985|NCT02236130||
723986|NCT02235987||
723987|NCT02235870|711 subjects signed an informed consent form to participate in the study and proceeded to the screening eligibility process|430 subjects randomized in a Treatment or Control group, 387 subjects received an Obalon Balloon or Sham Device.
723988|NCT02235831|Subjects were recruited from 1 study center located in Spain.|Twenty-four subjects were enrolled; all enrolled subjects were also randomized. This reporting group includes all randomized subjects (24).
723989|NCT02235493||
723990|NCT02235454||
723991|NCT02235311|Three participants signed the consent form. One went on to complete the study; 1 was terminated by PI before starting the treatment and 1 was lost to follow-up before starting the treatment.|
723992|NCT02235285|Retrospective analysis was performed on 162 patients undergoing primary breast augmentation by a single surgeon during a 5-year period from 2010 to 2015.|This study presents data for 162 primary breast augmentation in either alone (n=152; 93.82 percent) or in conjunction with mastopexy (n=9; 5.56 percent) and inverted nipple correction (n=1; 0.62 percent) .
723993|NCT02235077||
723994|NCT02235064||
723995|NCT02234843|Study was conducted at 109 study centers in 28 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Russia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, UK, and USA between 13 Nov 2014 and 30 Jan 2019.|A total of 520 children were screened for this study. Twenty children did not pass the screen of inclusion/exclusion criteria. A total of 500 children were randomized 2:1 to study treatment.
723996|NCT02234752||
723997|NCT02234713||Participants were assigned to a study arm after completion of the enrollment visit. Thus, any participants who consented but did not complete the enrollment visit were not assigned to a study arm.
723998|NCT02234687|No Outcome Measures Analyzed; Study Terminated|No Outcome Measures Analyzed; Study Terminated
723999|NCT02234622||
724000|NCT02234583|A total of 2485 participants who met all inclusion and no exclusion criteria enrolled from 04 Feb 2015 to 19 Apr 2017 at 406 clinic sites. Of the 2485 enrolled, 397 discontinued prior to randomization. A total of 2088 participants received study treatment.|Participants who completed the double-blind studies of DS-5565 in fibromyalgia were eligible to Rollover to this open-label extension study (referred to as Rollover participants). Participants who did not participate in a preceding double-blind study (referred to as De Novo participants) could be enrolled at the discretion of the Sponsor.
724001|NCT02234570|Participants were healthy adult males and non-pregnant females recruited from existing volunteer populations and from the communities at large around the clinical site. Participants were enrolled between 17NOV2014 and 09NOV2015.|
724002|NCT02234479||
724003|NCT02234427||
724004|NCT02234362|Participants were recruited through advertisements in the greater Boston metropolitan area.|
728210|NCT01921270||
728211|NCT01921257||
740819|NCT01130831||
724005|NCT02234323|The study was conducted at 44 active centers in 13 countries between 12-Jan-2015 to 23-Sep-2019.|110 participants screened, 108 enrolled, 103 received drug.
724006|NCT02234310|The study was conducted at 28 active centers in 11 countries. Participants were screened between 13-Nov-2014 to 23-Jul-2018.|A total of 38 participants were screened. A total of 33 participants were enrolled, 22 participants began study participation on episodic treatment regimen and 11 participants began study participation on prophylactic treatment regimen.
724007|NCT02234284||
724008|NCT02234180||
724009|NCT02234141|Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 November 2014. The last study visit occurred on 13 December 2016.|185 participants were screened.
724010|NCT02234128||
724011|NCT02234115||
724012|NCT02234063|Patients were recruited from 15 academic, community and safety-net practices in New York City. 2052 participants were enrolled. however 2 participants were not randomized.|
724013|NCT02234011||One subject completed the screening visit, but chose to withdraw from study due to time commitment required. Because this subject only completed a screening visit, she was never entered into the treatment arm of the study (which begins at the baseline visit).
724014|NCT02233998||
724015|NCT02233985||
724016|NCT02233842||Thirty-five subjects were recruited for this trial but three were unavailable due to time constraints, one was hesitant to participate and one refused to participate. As a result, only 30 subjects were enrolled in the trial. Five participants were assessed for each of the 6 different questionnaires to total 30 participants.
724017|NCT02233803|The study was conducted in adult asthma participants, at 11 centres in Argentina from 14 November 2014 to 11 December 2015.|Total 6 phases of study; pre-screening, screening/run-in, treatment period (TP) 1 washout, TP2, and follow-up. Out of total 239 enrolled participants, only 199 participants were randomized. 29 were screen failures and 10 were Run-in failures. One participant not randomized as the target number of participants for study was reached
724018|NCT02233751|Pharmacokinetics of single doses of Testosterone Enanthate administered via a drug-auto injector combination product in Healthy Male Subjects|Two dose groups, Testosterone Enanthate 50 mg and Testosterone Enanthate 200 mg , were evaluated in parallel with 6 subjects in each dose group.
724019|NCT02233738||Of the 481 patients screened between September 2015 and January 2018, 38% (n=185) were consented and enrolled. However, only 184 participants were randomized because 1 withdrew during baseline assessments.
724020|NCT02233647||Eleven subjects were enrolled (i.e., signed consent), but only 10 subjects completed. Due to the within-subject nature of this study (i.e., missing data from the 11th subject cannot be analyzed with repeated-measures ANOVA), only data from the 10 subjects who completed the protocol were analyzed and reported.
724021|NCT02233543||Participants were randomized in a 1:1 ratio.
724022|NCT02233517||30 participants were excluded after enrollment: 13 did not meet inclusion criteria; 17 declined to participate or were lost to contact.
724023|NCT02233478|The enrollment period was 08/01/2014 - 01/31/2015. Enrollment took place in a private setting in the clinic located at the site.|After a 4-day washout period, participants received pomegranate juice (PJ) alone, PJ mixed with soy protein, or PJ mixed with soybean flour in random sequence with a 7-day washout in between.
724024|NCT02233413||
724025|NCT02233309||
724026|NCT02233296|Fifty one (51) healthy participants were recruited according to the procedures of the Phase 1 unit. Thirty four were determined to be eligible. Thirty participants entered and completed the study.|
724027|NCT02233101||
724028|NCT02232984||A total of 749 subjects were enrolled. Of these, 7 did not complete baseline demographics due to early withdrawals and 1 additional was withdrawn due to LV lead not placed. Therefore, baseline demographics is based on a maximum of 742 subjects.
724029|NCT02232893|The study was carried out at 16 sites in the United States (US).|
724030|NCT02232880||One participant was consented. The study terminated before the participant was randomized. No participants received treatment.
724031|NCT02232802|Forty-seven (47) subjects (23 male and 24 female) were enrolled in the study. The subjects were selected from a large panel who offered their services as healthy volunteers for the purpose of undertaking REC and Regulatory Authority-approved studies on drug safety, absorption and disposition.|The study comprised a screening visit and 2 treatment periods. Only two doses were scheduled to be administered: first dose (period 1) - wash out (at least 7 days) - 2nd dose (period 2) - wash out period (at least 7 days). Each treatment period was of 2 days duration. Screening assessments: from Day -14 to Day -1.
724032|NCT02232698||A total of 328 subjects consented and enrolled into the study. Eighty-seven (87) of these failed screening or withdrew before randomisation. Two hundred and forty-one (241) subjects were randomised and 211 completed the study.
724033|NCT02232425||
724034|NCT02232243|This study was initiated July 2015 at the University of Kentucky and enrolled 10 adult patients with early stage solid malignancies.|10 patients enrolled in this dose escalation study. In Period 1, three patients were assigned to receive 200mg HCQ twice daily. Based on toxicity and PAR-4 levels, in Period 2 the next four patients received 400mg HCQ twice daily. Following additional analysis, in Period 3 the final three patients received 200mg HCQ twice daily.
724035|NCT02232178||
724036|NCT02232126||
724037|NCT02232087|Recruitment began 07 July 2014|
724038|NCT02232074||
724039|NCT02232022||
724040|NCT02232009||
724041|NCT02231918||Open label, single dose pharmacokinetic study in pediatric patients with a diagnosis of idiopathic Restless Legs Syndrome(RLS). For the dose MIRAPEX(0.5 mg),Only 2 subjects (12 to<18 years) were recruited and it was not likely that patients for this dose will be fully recruited so the recruitment was stopped and terminated for this dose only.
724042|NCT02231892||Orientation occurred prior to starting repetitive transcranial magnetic stimulation (rTMS) days. Orientation consisted of single-pulse TMS (allowed participant to experience TMS and researcher to find motor hotspot) and habituation (allowed participant to habituate to varied TMS intensities). Many ppts withdrew or were excluded during orientation.
724428|NCT02199964|Recruitment process occurred at the medical clinic of the primary investigator. Recruitment began July 2014 and ended December 2015.|There were no pre-assignment details.
724429|NCT02199795||
724043|NCT02231762|57 subjects entered a combination phase and received lanreotide ATG 120 mg plus temozolomide for 6 months. A 6 month maintenance phase then followed where subjects received either lanreotide ATG 120 mg or no treatment, dependent upon whether they had functioning or non-functioning NET, clinical benefit and allocation following randomisation.|Overall, 64 subjects were screened, 7 were screening failures of which 5 subjects did not meet the entry criteria. 57 subjects were assigned to receive treatment in the baseline population.
724044|NCT02231749||A total 1390 patients were enrolled in the study. Of these, 1096 were randomized. Of those randomized, 1082 received treatment (547 with Nivo+Ipi and 535 with Sunitinib). 240 patients who were not randomized because they no longer met study criteria, 24 withdrew consent, 4 for Adverse Events, 4 for Death, 4 for Poor Compliance, and 18 other.
724045|NCT02231580|The study was a double blind, placebo controlled, randomised, sequential dose ranging repeated dose trial where patients were recruited to a single study centre in Germany. It was planned to enrol 30 patients (10 in each of 3 cohorts). Patients were enrolled to the study from 1 September 2014 until early termination of the study on 31 March 2016.|Male patients 20-70 years with a documented diagnosis of Huntington's Disease (HD) with at least 36 cytosine adenine guanine repeats in the Huntington gene were screened. Eligibile patients needed to meet defined criteria during quantitative motor function assessments. 25 patients were screened, 17 were enrolled and randomised to treatment.
724046|NCT02231177||A randomised, double-blind, 3-way crossover study, each patient received each of the three treatments for 21 days according to randomisation.
724047|NCT02231164||
724048|NCT02230995||This was an open-label, randomised, 2-way crossover trial with 2 treatments (T and R) and 2 treatment sequences (T_R and R_T). Trial drug administrations of the 2 single dose treatments were separated by a washout period of at least 7 days.
724049|NCT02230956||
724050|NCT02230904|This study started to enroll subjects in September 2014 in Germany and concluded in December 2014.|Participant Flow refers to the Randomized Set.
724051|NCT02230761||
724052|NCT02230683||
724053|NCT02230670|A total of 140 subjects from 26 US sites were screened, of whom 87 subjects were randomized. One subject randomized to placebo withdrew from the study before taking study drug. Disposition data is provided for the initial 3-month randomized, placebo-controlled phase on which the primary efficacy and safety analyses were based|
724054|NCT02230579|For the purposes of this study, subjects that were re-used in SAD6 were treated as separate subjects, i.e. the entire trial population comprised 48 subjects, eight subjects in 6 cohorts.|
724055|NCT02230566||
724056|NCT02230540||
724057|NCT02230384||
724058|NCT02230332|Eligible participants were recruited from the community between January 2015 and May 2016 at 9 U.S. sites from the NHLBI AsthmaNet research network.|Participants with persistent asthma were first treated with fluticasone propionate 250mcg twice daily for 2 weeks during the run-in. Most of the participants who were not randomized did not meet the Salmeterol Protected Methacholine Challenge inclusion criterion.
724059|NCT02230306||
724060|NCT02230085||
724061|NCT02229864|The first subject was enrolled on June 2, 2014 and the last subject was enrolled on September 17, 2014. The last 30-day follow-up visit occurred on October 14, 2014. Database was locked on Oct 29, 2014.|In this sub-study, subjects received either one (N=8) or two (N=4) Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg.
724062|NCT02229851|The trial was conducted at 92 sites in 16 countries: Australia - 8, Germany - 4, India - 5, Japan - 14, Latvia - 1, Lithuania - 2, Malaysia - 3, Poland - 5, Romania - 5, Russian Fed. - 6, South Africa - 3, Sweden - 1, Turkey - 4, Ukraine - 1, United Kingdom - 4, United States - 26.|The trial had a main phase and an extension phase. Participants were treated for 34 weeks in the main phase (followed by 1 week washout) and for 52 weeks in the extension phase (followed by 1 week washout).300 participants received treatment;1 participant was randomised but didn't receive any treatment and was therefore not included in any analyses
724063|NCT02229552||
724064|NCT02229539|Two-hundred and seventy-five participants (92 Doxepin, 91 DLA and 92 Placebo) were enrolled between November 2014 to May 2016. Data as of 6/1/2016 was summarized for abstract submission, was reported.|Total of 47 participants were excluded from all analyses due to 23 cancellations, 18 with mouth pain score<4 prior to treatment, 4 with data being queried at the time of report, 1 with quality of life data non-compliance and 1 with randomization problem.
724065|NCT02229513||
724066|NCT02229487||
724067|NCT02229474||
724068|NCT02229461|The study was conducted at a single site in United States between 16-Feb-2015 (first patient first visit) and 08-May-2015 (last patient last visit).|Of 117 screened participants in Run-In period, 15 were not randomized into Treatment Period. 2 participants were not randomized because of non-compliance; 3 because of investigator's decision; the other 10 because of other reasons (e.g arachidonic acid-induced platelet aggregation≥20% or pre-randomization elimination of back-up participants).
724069|NCT02229396|Study conducted between 04 September 2014 and 28 December 2017. 118 centers in 6 countries randomized patients in the study. A Primary Analysis was performed following completion of the 28-week Treatment Period with a data cut-off date of 26 April 2016. All Primary and Secondary Outcome measures were reported at the time of the Primary Analysis.|The study had a Screening Visit, a 1-week placebo Lead-in Period, a Randomization Visit, and 9 further visits at 1- to 4-week intervals during a 28-week Treatment Period. Patients then entered a 24-week Extension Period 1 and subsequent 52-week Extension Period 2. A follow-up visit occurred 10 weeks after last dose of study medication.
724070|NCT02229383|This study was conducted in 107 centers globally between 06 September 2014 and 29 August 2016.|The study had a Screening Visit, an 8-week insulin dose optimization phase, followed by a 28-week randomized, double-blind treatment phase. A total of 464 participants were randomized and entered the double-blind Treatment Period. Of which, 3 participants from 1 center in the United States have been excluded from analyses.
724071|NCT02229318|Children between the ages of 4 and 8 years, attending the Ketogenic Diet Center at The Children's Hospital of Philadelphia were invited by email to attend a study family day held on a Saturday afternoon in September 2014. The first 12 families to respond were contacted via telephone and invited to enroll in the study.|12 families invited to participate, one subject failed to attend the recruitment family day and did not enroll in the study.
724430|NCT02199717||
724072|NCT02229227|This study was conducted from 21-Nov-2014 to 24-Jul-2017 at 186 centers in 14 countries: Canada, United States of America, Mexico, Brazil, Hungary, Poland, France, Germany, Italy, Spain, United Kingdom, Korea, Philippines and South Africa.|A total of 2004 participants were screened, of which 973 participants were screen failures and 160 participants were re-screened. A total of 1031 participants then entered the standardization period, of which 217 participants were standardization failures. A total of 814 participants were randomized in the study.
724073|NCT02229214||
724074|NCT02228980|The study participants were enrolled from 05 September 2014 to 09 October 2014 at 1 clinical center at the Province of Guangxi China.|A total of 602 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
724075|NCT02228967||
724076|NCT02228824|Participants were recruited from the greater Pittsburgh area from June 2015 through April 2017 via various channels (e.g., advertisements on local television stations, public transportation, and social media such as Facebook and Instagram), as well as through University-housed research registries and recruiting services.|Participants may have been excluded from the study after enrollment but before assignment to an arm if they were found to be unable to adhere to the study protocol or were unable to attend study visits, opted to no longer participate, or if they became unable to contact (i.e., were lost to follow-up).
724077|NCT02228720||
724078|NCT02228681|The study was activated on 02/19/2015 and closed to accrual on 04/18/2016. All patients underwent disease evaluation and were found to have measurable histologically confirmed advanced stage, persistent or recurrent endometrial carcinoma. After obtaining informed consent and verification of eligibility, patients were enrolled and treated.|
724079|NCT02228590|Patients with moderate to advanced Idiopathic Parkinson's Disease (PD) were recruited to this study in 4 study sites in the United States from August 2014. The study was completed in November 2014.|"23 patients were screened, 20 were assigned to treatment and 1 withdrew consent prior to treatment. 19 received APL-130277
~APL-130277 sublingual film for the acute intermittent treatement of OFF episodes in PD patients
~. Doses studied were 10, 15, 20, 25 and 30 milligrams (mg)."
724080|NCT02228564||
724081|NCT02228499||After participant enrollment the lead author of the study called to obtain report cards. Those participants for which a report card was unable to be obtained was not included in the GPA analysis.
724082|NCT02228460|Participants were enrolled in the study at 8 centers in 5 countries between 11 November 2014 and 06 September 2016. A total of 14 participants were screened in the study.|Out of 14 screened participants, 11 participants were enrolled and treated in the study.
724083|NCT02228395||Twelve participants were assigned study treatment. All participants received the assigned PF-04958242 doses during 3 periods (6 participants each received 0.35 mg, 0.6 mg and 0.8 mg doses, respectively). Nine participants received placebo. Three participants did not complete the study and they were replaced during the conduct of the study.
724084|NCT02228174||
724085|NCT02228096|"Patients were recruited between 14-Aug-2014 (FPFV) and 22-Sep-2017 (LPFV). At the time of LPLV (24-May-2019), the sponsor had decided to transfer all ongoing patients to a separate long-term follow-up study to complete the planned 15 years of follow-up. These patients are designated with the reason for discontinuation as terminated by sponsor."|"Enrolled means all eligibility criteria were met and apheresis was accepted by the manufacturing facility. Patients could discontinue the trial after enrollment and prior to tisagenlecleucel infusion. Although 75 patients were enrolled, only 64 were infused as 11 discontinued prior to infusion."
724086|NCT02227875||
724087|NCT02227862||
724088|NCT02227849||
724089|NCT02227836||
724090|NCT02227810|Recruitment period: 2012/08/01--2014/07/31 Location: respiratory care center|
724091|NCT02227784||
724092|NCT02227758||
724093|NCT02227706|Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until discharge and requested to attend a visit at 30 days (+/- 14 days) post surgery either at the hospital or via telephone.|"Subjects required to meet pre-defined inclusion/exclusion criteria prior to randomization. Subjects required to have an appropriate mild or moderate target bleeding site identified intra-operatively.
~Subjects were excluded if the target bleeding site was in an actively infected field or if the bleeding was at an anastomotic bleeding site."
724094|NCT02227693||A total of 56 participants were screened to enter into the study. Of these, 17 participants were screening failures, and 39 were randomized into the study. Of the 17 screening failures, 14 participants failed to meet the inclusion/exclusion criteria, 1 participant withdrew consent, and 2 participants were excluded for scheduling conflicts.
724095|NCT02227485|Recruitment for Chlorhexidine group started on 11/05/2014 and ended on 07/11/2014. For Golnaar group the starting and ending dates were; 01/05/2014 and 09/11/2014.|
724096|NCT02227368|"A total of 71 subjects were screened at 16 centers throughout the United States of America (USA).
~First subject enrolled: 20Oct2014. Last subject last visit: 23May2016. Date of early study termination: 21Oct2015"|A total of 40 subjects were randomised. Thirty-one subjects were not randomised due to not meeting inclusion/exclusion criteria (20 subjects), withdrawing consent prior to randomisation (2 subjects), and other reasons (9 subjects) including not being able to return for randomisation within 48 hours of the qualifying revascularization.
724097|NCT02227329|This clinical trial was carried out from July 2014 to April 2016 at the Mayo Clinic in Rochester, Minnesota.|39 subjects were consented, but one subject was excluded after enrollment due to incompatibility with ongoing treatment (ongoing metronidazole use).
724098|NCT02227316||No participants were excluded before assignment to groups.
724099|NCT02227238|This study assessed antiviral activity and safety of dolutegravir (DTG) in human immunodeficiency virus-1 (HIV-1) infected participants with treatment failure on first line therapy. The study consisted of randomized phase followed by continuation phase. The results presented are based on the Week 48 analysis (Randomized Phase only).|A total of 968 participants were screened and 627 were randomized in 1:1 to receive DTG or lopinavir/ritonavir (LPV/RTV). Three participants in the LPV/RTV group were randomized but not treated. Participants receiving DTG who successfully completed 52 weeks in the Randomized Phase could continue receiving DTG in the Continuation Phase.
732809|NCT01609543||A total of 651 participants were screened and among them 62 participants were enrolled in the study.
724100|NCT02227147|"Recruitment was competitive among the study sites, until the planned number of patients were randomized.
~Competitive recruitment was chosen to increase the speed of recruitment and to account for any difference in enrolment rate among study sites."|
724101|NCT02227121||
724102|NCT02227108||A total of 37 participants were screened, of which 5 did not meet eligibility criteria and were considered as screen failures; the remaining 32 participants entered into the study and 30 participants were treated with moxetumomab pasudotox.
724103|NCT02226965|The study was initiated in December 2014 and the first subject was enrolled on 10 December 2014. A total of 60 subjects were screened. Enrollment was closed as of 07 June 2016. Subjects were enrolled at oncology clinics in the USA.|
724104|NCT02226653||Periods 1 to 4 participants are in the fasting state and Period 5 participants were fed a low fat meal. There were two fixed sequences for Test (T) and Reference (R) doses with each participant receiving 5 doses. There was a washout period of at least 21 days between doses.
724105|NCT02226562|The participants were recruited at a clinical site in the USA|
724106|NCT02226549|Participants were enrolled at 1 study site in the United States. The first participant was screened on 24 July 2014. The last study visit occurred on 06 February 2015.|72 participants were screened.
724107|NCT02226198|Twenty HoFH patients were recruited to 9 centers within 8 countries (Belgium, Canada, Denmark, Israel, Malaysia, Sweden, Taiwan, and The Netherlands) that participated in the study. FSI date: 03-Nov-2014|20 enrolled, 3 withdrew consent, 3 did not fulfil eligibility criteria. Among the 14 left, ten went through 4 week lead-in phase and 4 did not.
724108|NCT02226172||In this study, 2 cohorts were involved lead-in and randomized cohort. Lead-in cohort was followed by randomized cohort. Though the drug was considered safe and tolerable in Myelofibrosis, but a key secondary efficacy outcome measure was not met. Therefore, continuation into the randomized cohort did not proceed.
724109|NCT02226159||
724110|NCT02226120|This study was conducted at 417 sites in 41 countries worldwide.|The total number in the participant flow and baseline characteristics sections reflects the number of participants treated (1980).
724111|NCT02226003|A total of 96 sites received independent ethics committees/institutional review boards' approval and 66 sites in 9 countries enrolled at least 1 participant.|The study included a 1-week screening period; an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period; and a 2-week single-blind placebo run-in period.
724112|NCT02225925||
724113|NCT02225860||
724114|NCT02225743||
724115|NCT02225587||
724116|NCT02225353|The trial started on 02 Sep 2013 with the enrollment of the first participant and was completed on 13 Mar 2017 when the last participant completed the last follow-up examination according to the protocol. 271 participants signed and informed consent. All 271 were randomized and treated.|
724117|NCT02225132||
724118|NCT02225106||
724119|NCT02225080||
724120|NCT02224846||
724121|NCT02224820|The study was performed at a medical clinic, the Department of Transplantat Surgery, Uppsala, SE between 10 Jun 2014 and 13 Feb 2015. The patients had chronic kidney disease, were in dialysis and on the waiting list for transplantation. (Transplantation was not part of the protocol).|In total, 10 patients were assessed for eligibility. One patient declined to participate and one patient was not available for recieving information about the study. Eight patients were enrolled and started treatment.
724122|NCT02224755|Subjects were recruited at 69 study sites in the United States from 2014 to 2016.|
724123|NCT02224729||
724124|NCT02224703|A total of 43 sites screened participants and 38 sites (23 in the United States, 7 in Spain, 3 in Poland, 2 in Australia, 1 in Israel, and 2 in the Netherlands) randomized participants into the trial. Two sites selected (1 in Israel and 1 in the United States) did not screen any participants.|To assess eligibility, participants, 2-18 years of age with Dravet syndrome had to be taking 1 or more antiepileptic drugs at a dose which had been stable; and medicated for epilepsy for at least 4 weeks were screened. A total of 285 participants were screened, of which 199 were randomized.
724125|NCT02224690||The dose level of 20 milligram (mg) per kilogram (kg) per day (mg/kg/day) was recommended by the GWEP1332 Part A (NCT02091206) Data Safety Monitoring Committee after assessment of safety and pharmacokinetic data. The investigational medicinal product (IMP) was given daily in 2 divided doses (the preferred dosing regimen for antiepileptic drugs).
724126|NCT02224664||Study consists of 2 periods: Lead-in period (Period 1) and dose escalation period (Period 2). Participants were enrolled in Lead-in period only. Participants completed the lead-in period entered into dose escalation period.
724127|NCT02224638||
724128|NCT02224625|39 of the 249 participants participated in both the Irritation and Sensitization Studies.|Participants received up to 5 products simultaneously on their skin. SLS was only used in the Irritation study (39 subjects) as a positive control.
724129|NCT02224612||Statistical analysis projected ninety-nine (99) Subjects were needed to assess mask equivalence, however only 96 subjects were enrolled at the facility.
724130|NCT02224599||
724131|NCT02224560||The dose levels of 10 and 20 milligram (mg) per kilogram (kg) per day (mg/kg/day) were recommended by the Data Safety Monitoring Committee (DSMC) of study GWEP1332 Part A (NCT02091206) after assessment of safety and pharmacokinetic data. Participants of GWEP1414 were not enrolled until the DSMC had reviewed the safety data of GWEP1332 Part A.
724132|NCT02224508||
724133|NCT02224404||
724134|NCT02224313||
724135|NCT02224274|Recruitment from August 2014 to May 2016 at UMC Ljubljana, Slovenia, Europe|Reasons for exclusion were intraprocedural eptifibatide/thrombolysis (11), decision of attending physician (8) and bradycardia (1)
724136|NCT02224157|4215 patients were enrolled. 26 patients were randomised in error and hence never recieved treatment.|Screening Details Eligibility was assessed at Visits 1, 2 and 3. IC was obtained at V1. At V2, patients stopped pre-study asthma medications and entered a 2 to 4 week run-in period on SABA as needed only (Bricanyl Turbuhaler 0.5 mg). Lung function was assessed by spirometry to confirm eligibility. Eligible patients were randomised at V3.
724278|NCT02212106|First Patient In: 22-SEP-2014, Last Patient In: 15-OCT-2014, Last Patient Last Visit: 05-DEC-2014. Number of activated sites that enrolled subjects: 11 (all based in USA).|Number of subjects screened: 407 Number of screen failures: 5 (Reason: all due to not meeting inclusion/exclusion criteria).
724137|NCT02224053|First subject enrolled: 3 September 2014 Last Subject Last Visit: 5 January 2015 Study was performed at 2 sites in the USA.|"136 subjects were enrolled (signed informed consent). Subjects were assigned to treatment if they met all the inclusion and none of the exclusion criteria.
~68 subjects were enolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment.
~The remaining 68 subjects started period 1 and received treatment."
724138|NCT02223871|This proof-of-concept study was conducted in 8 subjects at a single center in Australia. All the subjects were screened from June 6, 2014 to June 23, 2014 and all were enrolled in the study on June 25, 2014 (Study Day 0).|
724139|NCT02223858|Patients with symptomatic knee OA from Veterans Affairs (VA) medical centers in Pittsburgh and Philadelphia, Pennsylvania, were recruited by mail and telephone. Mailings were sent to patients meeting basic eligibility criteria based on their VA medical records Recruitment for the study ran from July 2015 to February 2017.|Eligible patients attended an in-person baseline visit where they provided written informed consent, completed a staff-administered baseline assessment, and were randomized to a 6-week positive psychological intervention or neutral control program.
724140|NCT02223793||
724141|NCT02223754||This study enrolled a total of 371 subjects. Of those enrolled subjects 49 did not meet the eligibility criteria and 322 subjects were dispensed a study lens. Of the dispensed subjects 297 completed the study and 25 were discontinued from the study.
724142|NCT02223715||
724143|NCT02223702||
724144|NCT02223689||
724145|NCT02223650|Between December 2014 and May 2015, 58 children were enrolled at 21 sites, with 31 participants assigned to observation and 27 to overminus treatment.|
724146|NCT02223637||Of the 93 subjects included in the registry,82 subjects were included for analysis as 7 lost to follow up & 4 were invalid cases. Of these 82 subjects,1 pregnancy resulted in 1 set of twins birth.Analyses on outcome measures were performed on pregnant outcomes(Analysis population pregnancy outcomes)& on live births(Analysis population live births)
724147|NCT02223546||
724148|NCT02223520||
724149|NCT02223455||
724150|NCT02223429|Enrollment took place from 9/29/2014 through 2/3/2016.|Of the 35 participants consented for participation, 32 began the study. Three participants were lost to follow up after signing the consent form.
724151|NCT02223390||
724152|NCT02223364|Subjects were recruited at Mayo Clinic in Rochester, Minnesota from October 2014 to December 2015.|
724153|NCT02223351|Participants took part in the study at one investigative site in United Kingdom from 05-September 2014 to 04-December 2014|
724154|NCT02223338||
724155|NCT02223260||This was an open-label, multicentre, multinational, non-randomised, uncontrolled, single dose, single arm Phase IIa study.
724156|NCT02223065|Open-label, randomized, single-dose, 2-treatment, 2-period crossover study in 36 healthy subjects. A single dose was administered on Day 1 and Day 8 under fasted conditions. Blood samples for the plasma pharmacokinetic analysis collected over a 60-hour interval after dosing in each period|
724157|NCT02222922||"Once every 3 weeks (Q3W) Regimen: A total of 113 participants were enrolled to study treatments and 1 participant in the PF-06647020 2.1 mg/kg treatment group didn't receive any study treatment.
~Once every 2 weeks (Q2W) Regimen: A total of 25 participants were enrolled to study treatments and all were treated with study drug."
724158|NCT02222870|Study participants were enrolled from 19 August 2014 to 06 November 2014 at 2 clinical sites in the United States.|A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.
724159|NCT02222818|A total of 71 subjects were enrolled from 22 investigational centers in the United States, Europe and Middle East. The first subject was enrolled on 07 Oct 2014, and last enrollment was on 08 Jan 2016.|Of the 71 enrolled subjects, 5 did not meet eligibility criteria (AV node ablation - 2, complete heart block - 3) and were exited from the study prior to randomization assignment.
724160|NCT02222714||
724161|NCT02222688|Subjects were enrolled into the study between August 2014 and September 2017 and included patients seen in the UCSD Health system.|Twenty-seven subjects were treated with cirmtuzumab and are included in the primary outcome analysis. One subject was enrolled into the trial twice; first in Cohort 1 and then again in Cohort 4 and is counted once for reporting of the baseline characteristics.
724162|NCT02222558|The planned enrollment for this study was up to 28 subjects. The actual enrollment of the study was 25 subjects, all of whom were included in the safety and PK evaluable populations. This was a single-center study conducted at San Diego Sexual Medicine medical clinic. First patient screened 27Aug2014, FPE 05Sep2014, LPE 28Jan2015, LPLV 24Apr2015.|Period 1: Each study subject received 5 escalating single doses of TSX-002. Period 2: Each study subject dose was 90 mg BID of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level was drawn and used to determine eligibility for randomization to a further treatment group (BID vs. TID) or continuation in a BID treatment regimen.
724163|NCT02222493||A total of 1603 participants were screened after signing an informed consent form, of whom 650 participants were randomized to receive study treatment. One (1) participant in the PF-06438179 arm was screened and randomized by 2 different study site personnel, and no data were collected for the participant's second randomization.
724164|NCT02222337||"We reconciled the prior enrollment number in the Protocol Section (i.e., 272) that had conflicted with the number of participants started in the Participant Flow module (i.e., 270). The discrepancy was because two participants enrolled but withdrew prior to the baseline interview. We thus did not have any data on these 2 participants."
724165|NCT02222246||106 subject were enrolled and consented to participation during all future Emergency Department (ED) visits for vaso-occlusive crises (VOC), should they occur, over the study period. 53 subjects were randomized to each arm.
724166|NCT02222207|The study was conducted at 27 centers, between 10 October 2014 (first subject first visit) and 17 June 2015 (last subject last visit).|Study was planned to be conducted in 2 parts, Part A and B, in Part A 89 subjects were enrolled, of them 37 were screen failure and 52 were assigned to treatment, 1 subject was excluded from all analysis sets due to protocol deviations and 51 subjects were analyzed. Part B was not initiated and the study terminated following completion of Part A.
724381|NCT02203032||Study consists of 2 periods: Open label run-in (Period 1) and blinded phase (Period 2). Participants were enrolled in open label run-in period only. Participants completed the open label run-in period entered into blinded phase period.
724167|NCT02222181|Experimental, longitudinal and non-randomized study, carried out at Centro de Referência do Idoso de Araraquara (CRIA), from 2014 april to 2015 april, with patients in treatment for Alzheimer's disease.|Patients were excluded when in advanced or terminal stage of the disease, lived in nursing homes and when it was not possible to contact the patient.
724168|NCT02222129||
724169|NCT02221947||
724170|NCT02221882||Participants, who completed at least 1 cycle of treatment or discontinued due to an adverse event during Cycle 1 and completed the required post-treatment safety assessment, were considered to have completed the study.
724171|NCT02221869|106 subjects were enrolled. Xyrem-naïve subjects (n=74) entered the Dose Titration Period (3 to 10 weeks). Xyrem-naïve and on Xyrem subjects (n= 99) entered the Stable Dose Period (2 to 3 weeks). 96 subjects then entered the Double-Blind Randomized Withdrawal Period (2 weeks). 95 subjects then entered the Open-label Safety Period (38 to 47 weeks).|Subjects aged 7-17 who were being treated with Xyrem or Xyrem naïve were eligible for the study. 63 subjects were randomized and 33 received open-label Xyrem during the Double-blind Treatment Period. 106 and 63 subjects comprised the Enrolled population and the Efficacy population respectively.
724172|NCT02221739||
724173|NCT02221674|The first patient signed the informed consent on 05 Nov 2014. The last patient completed the trial on 03 Nov 2016. The trial followed a staggered recruitment by age, starting with the recruitment of patients in the oldest age group. Exposure and safety of at least 2 patients has been assessed before opening enrollment in the next younger age group.|"Consent was obtained for 40 participants in the trial. 19 participants were allocated and received study drug (investigational medicinal product). Pharmacokinetic data was obtained for 18 participants.
~21 patients were enrolled but not allocated."
724174|NCT02221648|Due to relocation of PI, study was terminated with 43 enrollments(total).|
724175|NCT02221557||
724176|NCT02221349||
724177|NCT02221284|Participants took part in the study at 196 investigative sites in Japan, from 30 June 2014 to 30 June 2017. Data reports overall population, since data not collected separately per arm as specified in protocol.|Enrolled participants had a diagnosis of type 2 diabetic mellitus and an inadequate response to hypoglycemic agents in addition to dietary/exercise therapy. Participants received interventions as part of routine medical care. Data reports overall population, since data not collected separately per arm as specified in protocol.
724178|NCT02221219||
724179|NCT02221037|The study was conducted at 8 centers in the United Kingdom from 28-Apr-2015 to 28-Jun-2017.|A total of 54 participants (included 2 participants who were screen-failures and were re-screened) were screened, of which 21 participants (2 re-entered study) were screen-failures (SF). Reasons for SF: study procedure could not be performed (4), inclusion/exclusion criteria not met (14), study closed/terminated (1) and investigator discretion (2).
724180|NCT02220998|Participants were enrolled at study sites in the United States. The first participant was screened on 22 September 2014. The last study visit occurred on 03 September 2015.|317 participants were screened.
724181|NCT02220920||
724182|NCT02220907||
724183|NCT02220894|Of the 1275 participants randomized (pembrolizumab=638, chemotherapy=637), 1 participant assigned to receive pembrolizumab died prior to randomization and was randomized in error. The intent to treat population was defined as participants alive at the time of randomization, so the actual randomized population included 637 participants in each arm.|These interim results are based on a database cutoff date of 26-February-2018, at which time 448 participants were ongoing in the study.
724184|NCT02220855|This protocol was based on enrolling at least 16 patients. The protocol enrolled 14 patients due to lack of funding.|
724185|NCT02220764||
724186|NCT02220725|Subject recruitment occurred at investigative site in the US between May 2014 through June 2015|Rivaroxaban was administered orally at 20 mg once daily for 4 days followed by andexanet as a bolus (800 mg; Part I) or as a bolus followed by an infusion (800 mg bolus followed by 8 mg/min infusion for 120 minutes, 1760 mg total dose; Part II). Bolus was started 4 hours after the last rivaroxaban dose.
724187|NCT02220205||One participant voluntarily withdrew from the study due to time constraints which precluded completion of the study visit. Therefore, 60 participants enrolled and were randomized, and 59 completed the study.
724188|NCT02219997|Subjects were recruited from 6 study centers located in the US.|Of the 90 enrolled, 22 subjects were exited prior to reaction testing. This reporting group includes all subjects who were reaction tested (68).
724189|NCT02219932||A total of 646 participants were enrolled. A single site in Poland was later closed due to serious Good Clinical Practice noncompliance issues observed during the conduct of the study. There were 10 participants randomized at this site (6 to fampridine and 4 to placebo). The data from this site were excluded from all analyses.
724190|NCT02219685|Participants were enrolled at 1 study site in the United States. The first participant was screened on 25 August 2014. The last study visit occurred on 07 April 2016.|54 participants were screened.
724191|NCT02219516|31 subjects were randomized|Thirty-one subjects were randomized to 1 of 4 cohorts. Cohort 1: mild renal impairment; Cohort 2: moderate renal impairment; Cohort 3: severe renal impairment and Cohort 4: normal renal function. All 31 subjects received a single dose of 15 mg RDEA3170 (6 x 2.5 mg) in the fasted state.
724192|NCT02219503|A total of 60 subjects were enrolled and all the subjects completed the study. All 60 subjects were analyzed for both efficacy (included all participants who received at least 1 dose of study drug (ITT)) and safety.|
724193|NCT02219477||
724194|NCT02219464||
724195|NCT02219334||
724196|NCT02219321||
724197|NCT02219308|Inclusion: Nulliparous women, 18-45, requesting IUD, seen in our clinic from October 2014 through October 2017 Exclusion: pregnancy, diagnosed chronic pain issues, use of pain medication within 6 hours, misoprostol administration within 24 hours, history of prior IUD placement, known contraindications to IUD placement.|
724198|NCT02219282||
724199|NCT02219256|Participants took part in the study at 1 investigative site in the United Kingdom (UK) from 01 August 2014 to 29 April 2016.|Healthy participants were enrolled in 1 of 12 treatment groups to receive: TAK-079 placebo, 0.0003, 0.001, 0.003, 0.01, 0.03, 0.06 milligram per kilogram (mg/kg) Intravenously (IV) and TAK-079 placebo, 0.03, 0.1, 0.3, 0.6 mg/kg subcutaneously (SC).
724200|NCT02219087||
724201|NCT02219048||
724382|NCT02203019||
724202|NCT02219009|The trial was conducted in 67 participants at 6 trial sites in the United States.|The trial included a screening period (≤ 2 weeks), a treatment period (8 weeks), and a safety follow-up period (2 weeks). Participants enrolled under the original version of the protocol were considered to comprise a first cohort (Cohort 1), while subjects enrolled under Amendment 1 were considered to comprise a separate second cohort (Cohort 2).
724203|NCT02218736||69 participants screen failed, 2 were unable to complete baseline per protocol, 3 withdrew consent prior to baseline.
724204|NCT02218697|In the Control Group, 2 subjects withdrew at Day 0. In the Co-Ad Group, 4 subjects withdrew at Day 0, 1 subject withdrew at Day 28 and 1 subject withdrew at Day 56.|Of the 357 subjects enrolled, 1 subject failed to meet the inclusion criteria hence he/she was excluded from study start.
724205|NCT02218541||
724206|NCT02218463||
724207|NCT02218424||
724208|NCT02218372|Pediatric participants with clostridium difficile-associated diarrhea (CDAD) were enrolled in this multicenter study.|Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled, 159 participants were assessed for eligibility of whom 148 were randomized. Participants were randomized to either fidaxomicin or vancomycin in a 2:1 ratio, stratified by age group.
724209|NCT02218320|Recruitment began upon IRB approval. Patients were enrolled from December 2014 to October 2015, at which time data analysis ensued. Enrollment continued until 20 subjects completed all study procedures. Patients were recruited from the Infectious Disease clinics associated with the University of North Carolina at Chapel Hill.|After informed consent, all patients underwent a screening visit to determine eligibility. This visit had to occur within the 6 weeks prior to study enrollment. Patients were enrolled into the group that matched their treatment regimen.
724210|NCT02218307||
724211|NCT02218268||
724212|NCT02218242||
724213|NCT02218216||Volunteer Control participants were scanned only for the purpose of operator training and calibrating the MRI device. No data was collected from these participants for the the purpose of analysis.
724214|NCT02218203|Recruitment began in March 2003. Subjects were recruited nationally from referring physicians, through advertisements, and through an existing database held by the PI.|During the screening visit, P450 2D6 phenotype status was determined for each subject to identify dextromethorphan-metabolizing capacity; those who were P450 2D6 poor-metabolizers were excluded. Following screen, subjects entered a dose escalation study to determine their maximum tolerated dose of dextromethorphan, prior to randomization.
724215|NCT02218190||5 Patients enrolled and withdrew prior to undergoing randomization, surgery and treatment
724216|NCT02218164|Participants were recruited at Moffitt Cancer Center from August 2014 through May 2017.|
724217|NCT02218008|Subjects were diagnosed with major depressive disorder (MDD), and had an inadequate response to 1 or 2 adequate courses of treatment with a commercially available antidepressant therapy (ADT) during the current major depressive episode (MDE). All subjects continued ADT for the duration of the study.|This was a Sequential Parallel Comparison Design (SPCD) study comprised of 2 stages. In Stage 1 subjects were randomized to ALKS 5461 or placebo (2:2:9). In Stage 2 only placebo non-responders from Stage 1 were re-randomized to ALKS 5461 or placebo (1:1:1). 1 subject randomized to the placebo group in Stage 1 did not receive any study drug.
724218|NCT02217982||
724219|NCT02217904||Additional panels (F: 0.25 mg islatravir; and G: 30 mg islatravir Extended Observation) were initially planned but were not conducted.
724220|NCT02217878||
724221|NCT02217800||
724222|NCT02217618||
724223|NCT02217566|A total of 46 participants were enrolled into the study and were treated with abiraterone acetate and prednisone. Out of 46 participants, 6 did not fulfill all eligibility criteria and included in the safety population. Thirty-five (35) participants completed the study.|
724224|NCT02217527||All enrolled after confirmation of eligibility were then assigned to Order 1 or Order 2.
724225|NCT02217475||In total, 812 participants were screened, and 289 participants were randomized to treatment period 1. Of the 289 participants randomized, 250 participants completed Treatment Period 1. A total of 242 participants entered Treatment Period 2 and 212 completed.
724226|NCT02217436||105 eligible patients were approached and 25 refused to participate in the study (not consented), 80 participants were randomized, and 3 withdrew from the study.
724227|NCT02217410|In Part 1, patients were enrolled into Arm 1. In Part 2, patients were randomized (2:1) to Arms 2A and 2B.|"Study Part 1 focused on measuring the multiple-dose safety, tolerability, PK, and PD of both IV and SC CFZ533 when administered with the SoC treatment regimen.
~Study Part 2 investigated efficacy, safety, tolerability, PK and PD of CFZ533 in the absence of Tac."
724228|NCT02217280||
724229|NCT02216812||
724230|NCT02216773||
724231|NCT02216695|The recruitment was from Hospital episode statistic dataset|
724232|NCT02216591|Adult persons living with HIV were recruited from the Durham area between January 2015 and May 2016 via flyers and brochures at community-based organizations and infectious diseases clinics.|Interested persons completed a comprehensive in-person eligibility screen prior to group assignment. 33 participants completed the in-person screen, and 12 were not eligible (5 had no memory impairment, 3 had a current substance use disorder, 2 had a history of brain injury, 1 had severe mental illness, and 1 was not interested).
724233|NCT02216526|completed, recruitment period: September 2014 to May 2015, nursing homes|
724234|NCT02216422|A total of 36 participants were enrolled and all the participants completed the study. All 36 participants were analyzed for both efficacy (included all participants who received at least 1 dose of study drug (ITT)) and safety.|
724235|NCT02216357||
724236|NCT02216214|Participants who were ≥ 65 years who had symptoms of overactive bladder (OAB) were enrolled in 102 centers in 2 countries (US and Canada).|Eligible participants entered into a 2-week placebo run-in period. During this time, they were asked to complete a 3-day training micturition diary and in the 3 days prior to being randomized (and after, prior to each visit). Participants were randomized in a 1:1 ratio to either mirabegron or placebo, stratified by age (< 75 years, ≥ 75 years).
724383|NCT02202980|Participants were enrolled at study sites in New Zealand. The first participant was screened on 04 August 2014. The last study visit occurred on 09 May 2016.|349 participants were screened.
724384|NCT02202850||
724385|NCT02202837||
724237|NCT02216136|Mastectomy Only cohort was unable to enroll participants due to: participants who chose mastectomy with no reconstruction almost never had an MRI and MRI was a critical inclusion criteria; most of the participants who were approached were older and refused participation; issue with finding and tracking participants who refused reconstruction|
724238|NCT02216123|This is a randomized, double-blind, double-dummy, comparative, multicenter study to assess the incidence of hemolysis, safety and efficacy of Tafenoquine (TQ) versus Primaquine (PQ) in treatment of participants with Plasmodium vivax (P. vivax) malaria.|A total of 369 participants were screened of which 118 failed screening and 251 participants were randomized to receive either TQ+chloroquine (CQ) or PQ+CQ in a ratio of 2:1.
724239|NCT02216097||
724240|NCT02215967||
724241|NCT02215954||
724242|NCT02215616|A total of 468 participants were screened, of whom 116 participants were screen failures and 352 participants were enrolled. Of 352 enrolled participants, 123 participants were randomized in 1:1:1:1 ratio to receive laquinimod 0.5, 1.0, 1.5 milligrams/day (mg/day), or matching placebo prior to 10 January 2016.|As of 10 January 2016; following recommendation of Data Safety Monitoring Board (DSMB), treatment of laquinimod 1.5 mg dose arm was discontinued as a proactive safety measure. After 10 January 2016; additional eligible participants, who were enrolled, were randomized in 1:1:1 ratio to receive laquinimod 0.5 mg/day, 1.0 mg/day, or matching placebo.
724243|NCT02215369||
724244|NCT02215252|"Eligibility included healthy male and/or female participants of non childbearing potential between the ages of 18 and 80 years, inclusive, and a diagnosis of painful diabetic peripheral neuropathy and type II diabetes.
~Following the interim analysis, the study was stopped. No participants were dosed with PF-05089771 150mg BID + pregabalin."|"A number of 141 participants were the anticipated to be enrolled based on a discontinuation rate calculated from previous Pfizer DPN studies.
~The study discontinuation rate was lower than anticipated, hence fewer participants were randomized."
724245|NCT02215200||
724246|NCT02215161||
724247|NCT02215096|This was an open-label, dose finding study of GSK2636771 administered in combination with Enzalutamide in male participants with Metastatic Castration-Resistant Prostate Cancer (mC-RPC) conducted at 7 centers across United Kingdom and United States.|A total 37 participants were enrolled in this study and entered in the enzalutamide run-in period, of which 36 participants received GSK2636771+enzalutamide and completed the combination treatment period (TP).
724248|NCT02215070||5 enrolled participants screen failed, 5 withdrew, and 1 was withdrawn by physician decision.
724249|NCT02214628||
724250|NCT02214615||
724251|NCT02214420||
724252|NCT02214290|Sixteen young healthy men participated in this study. All subjects were non-smokers, recreationally active, and free of apparent cardiovascular-metabolic diseases based on medical history.|Of the 42 individuals screened, 16 individuals completed the intervention in its entirety.
724253|NCT02214277||
724254|NCT02214238||
724255|NCT02214225|First Patient In: 15-AUG-2014, Last Patient Last Visit: 20-APR-2015. Number of activated sites that enrolled subjects: 31 (all based in USA).|Number of subjects screened: 3673. Number of subjects randomized: 3484.
724256|NCT02214186||We calculated the total sample size from a pilot study. Assuming a power of 80% and 95% confidence, the sample necessary to conduct the study was 21 patients in each group of interest. As we considered 10% as maximum margin of loss during follow-up, there were 23 patients enrolled in each group.
724257|NCT02214147|Participants took part in the study at 6 investigative sites in the United States from 21 August 2014 to 18 July 2016.|Participants with a diagnosis of advanced solid tumors or relapsed/refractory lymphoma were assigned to 1 of 3 hepatic function groups (normal hepatic function, moderate hepatic impairment, or severe hepatic impairment) on the basis of their total bilirubin and alanine aminotransferase (ALT) values. All participants received alisertib.
724258|NCT02214121|The study was conducted at 24 centres, in 6 countries. The first patient was enrolled to Part A of the study on 11 Sep 2014, and the last patient completed Part B of the study on 27 Feb 2017. Recruitment was stopped due to protocol amendment between 8 September 2015 and 1 June 2016.|46 patients were randomised to Part A of the study (open label). Of the patients completing Part A, 25 were randomised to Part B of the study (double blind)
724259|NCT02214017||
724260|NCT02213926||
724261|NCT02213900||
724262|NCT02213666|Patients were interviewed in the pre-procedure room on the day of the planned procedure after consenting for the planned clinical procedure. A Co-Investigator introduced and discussed the study with the patient in detail, provided the consent form to review and addressed any questions.|
724263|NCT02213510||
724264|NCT02213263||A total of 394 participants were enrolled and randomized in 1:1 ratio to 1 of the 2 study treatment arms: PF-05280586 (Rituximab-Pfizer) and Rituximab-EU (MabThera®).
724265|NCT02213250|Twelve (12) participants that were age 6 years or older (weight ≥20 kg) with moderate severe to severe hemophilia B (FIX activity ≤2%) were enrolled. Four (4) participants were at the younger age range of ≥6 and <12 years; remaining participants were 12 years or older.|Participants did not receive an infusion of any FIX products for at least 4 days and were required to be in a non-bleeding state before the administration of BeneFIX on Day 1.
724266|NCT02213198||
724267|NCT02213133|The study was conducted at 14 sites in United States and 1 site in Canada between 22 September 2014 and 10 December 2015.|A total of 45 participants were enrolled and randomized.
724268|NCT02213094||
724269|NCT02213055||
724270|NCT02212977||
724271|NCT02212834|Cohort analysis of women with one or more observed breast cancer surveillance exams and primary cancer diagnosis between 2003 and 2012|Not a clinical trial. Analyses were conducted with the entire population who met study criteria. Unit of analysis was surveillance exam.
724272|NCT02212730||
724273|NCT02212678||
724274|NCT02212587||
724275|NCT02212457|Subjects were recruited from 32 centers from Finland, Poland and United States.|All subjects were included in the trial.
724276|NCT02212301||A total of 45 subjects were enrolled into this study. Of the enrolled subjects 43 were dispensed and 2 subjects did not meet the eligibility criteria. Of the 43 dispensed subjects, 1 subject was discontinued 42 subjects completed the study.
724277|NCT02212197||
724279|NCT02212028|Between October 15, 2014, and August 12, 2015, there were a total of 123 patients presenting with a STEMI at the University of Florida Health-Jacksonville, that were screened.|45 patients did not meet study entry criteria, while 78 provided their written informed consent to participate in the study and, of these, 52 were randomized. the remaining subjects were not randomized because of exclusion criteria emerged after consenting.
724280|NCT02211638|Participants took part in the study at 1503 investigative sites in Japan, from 13-Jun-2011 to 25-Apr-2013.|Participants with a diagnosis of hypertension were enrolled to receive candesartan cilexetil 4 mg - 8 mg, tablet, orally, once daily for up to the last dose of study drug (up to Month 6).
724281|NCT02211534||
724282|NCT02211495||
724283|NCT02211313||
724284|NCT02211261||
724285|NCT02211131|"This study was conducted at 35 centers in Australia, Brazil, Europe, Russia, and the United States.
~Data presented are based on the primary analysis (data cutoff date of 30 April 2019)."|Participants were randomized 1:1 to receive either talimogene laherparepvec for 6 doses followed by surgical resection of melanoma tumor lesions or immediate surgical resection of melanoma tumor lesion(s). Randomization was stratified by disease stage and planned adjuvant therapy.
724286|NCT02211014|Multicenter, open-label, randomized, parallel-group study to evaluate the safety, pharmacokinetics, pharmacodynamics and activity of acalabrutinib with/without dexamethasone in subjects with relapsed/refractory multiple myeloma in US and United Kingdom. 27 subjects enrolled into 2 cohorts. Enrollment was discontinued because of lack of efficacy.|
724287|NCT02210780|The study was conducted at approximately 50 study sites in United States (US) between 05 August 2014 and 15 September 2015. A total of 243 participants were screened in the study.|Out of 243 participants, 194 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive 600 mg subcutaneous (SC) dupilumab loading dose on day 1 and then dupilumab 300 mg once weekly (qw) or placebo qw.
724288|NCT02210689||The populations for this study included the Safety Population, the Per-Protocol (PP) Population, and the Modified Intent-to-treat (mITT) Population.
724289|NCT02210221|CENTER-TBI is an observational cohort study. Data from 4509 patients from 18 countries, collected between Dec 9, 2014, and Dec 17, 2017, are analysed in the core study: 848 (19%) patients were in the ER stratum, 1523 (34%) in the admission stratum, and 2138 (47%) in the ICU stratum.|Of 4559 patients in the core study, 4509 patients are available for analysis.
724290|NCT02210208||
724291|NCT02210195||
724292|NCT02210091|52 sites participated in this study. 39 study sites enrolled participants and 13 sites were initiated but were inactive.|73 participants enrolled and were screened for study participation. There were 9 screen failures. Among these, 2 participants were screen failures at first screening but entered the study later. 66 participants were dosed in the prophylactic part of the study, of whom 31 participants were also dosed in the PK part prior to prophylaxis.
724293|NCT02210065|All participants were registered in UT MD Anderson Cancer Center.|Five participants did not receive treatment as either they did not have CMV reactivation or had relapse of their primary malignancy and received treatment for relapse.
724294|NCT02210052||
724295|NCT02210039||
724296|NCT02210000|This study was conducted from 27 August 2014 till 24 August 2015 across 34 centers in the united states (US). A total of 120 participants with gastroparesis and Type 1 or 2 diabetes mellitus were planned to be enrolled.|A total of 387 participants with gastroparesis and Type 1 or 2 diabetes mellitus were screened, of which 273 participants did not meet the inclusion/exclusion criteria and thus, were screen failures. A total of 114 participants were randomized in the study. Participants started recording GCSI-DD for 7 days post-screening to assess baseline symptoms
724297|NCT02209766|86 male subjects were screened.|Of the 86 subjects, 43 did not meet the inclusion/exclusion criteria, 14 decided not to participate in the study and 5 had other reasons for declining participation in the study.
724298|NCT02209610||
724299|NCT02209597||
724300|NCT02209532||
724301|NCT02209519||
724302|NCT02209506|Participants took part in the study at single site in the United States from 04 August 2014 to 09 December 2014.|Part A was performed on non-Japanese participants and Part B was performed on Japanese participants. Planned doses of MLN3126 800 mg to be decided (TBD) dose for Part A, and MLN3126 300 mg, 800 mg, and TBD dose for Part 2 were not administered due to early termination of the study.
724303|NCT02209454||
724304|NCT02209272||
724305|NCT02209259||
724306|NCT02209181||
724307|NCT02209064|25 Patients were enrolled at five sites in Europe between February 7th 2014 and March 16, 2015|
724308|NCT02208999|Recruitment between December 3, 2015 and October 21, 2015 in 7 French clinical centers|No pre-assignment details
724309|NCT02208843|An open-label, single-arm phase IV study to assess the efficacy and safety of Afatinib as second-line therapy for patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harbouring an Epidermal Growth Factor Receptor(EGFR) mutation (Del19 or L858R) who have failed first-line treatment with platinum-based chemotherapy.|All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial treatment if any one of the specific entry criteria were not met.
724310|NCT02208349||83 were enrolled and 82 met inclusion criteria.
724311|NCT02208310||
724312|NCT02208297||
724313|NCT02208089|Patients with Stage I-III keratoconus and corrected vision <20/20 were recruited. Recruitment period: August 2014-July2015. Location: dedicated keratoconus clinic at Moorfields Eye Hospital, London.|63 eligible patients were screened; 11 declined to participate after discussing consent information; 5 patients were found to be ineligible because of insufficient residual corneal stromal depth following PRK programming, leaving 47 patients who were treated with TransPRK/CXL
724314|NCT02208063||
724315|NCT02208037||
724316|NCT02207972|Patients in labor requesting epidural will be offered to participate in the study for their neuraxial placement|Once the patient agrees to be in the study, they will be randomized into one of the 2 arms (with or without ultrasound) for their neuraxial placement.
724317|NCT02207907|The participants were recruited at a clinical site in the USA.|
732810|NCT01609478||
724318|NCT02207829||Participants (Par.), with clinical history of chronic obstructive pulmonary disease, who met eligibility criteria at screening were enrolled in a 7 to 14 days run-in period. Eligible par. were randomized (1:1) to receive umeclidinium or tiotropium. A total of 1214 par. were screened; 1017 par. were randomized and entered into the study.
724319|NCT02207816|The randomization that was performed in the primary study NCT00866619 was kept for this extension, in which subjects from 3 sites were enrolled. Subjects remained in the same groups as the ones of the primary study.|
724320|NCT02207803||
724321|NCT02207725|Subject recruitment occurred at investigative site in the US between March 2014 through December 2014|Apixaban was administered orally at 5 mg twice daily for 3.5 days to steady-state and then administered andexanet as a bolus (400 mg; Part I) or as a bolus followed by an infusion (400 mg bolus followed by 4 mg/min infusion for 120 minutes, 880 mg total dose; Part II). Bolus was started 3 hours after the last apixaban dose.
724322|NCT02207634|"Participants enrolled in Study 20110118 (FOURIER; NCT01764633) at select sites in select countries (based on study start-up timelines) were invited to participate in this cognitive function study.
~Participants were enrolled at 340 centers in 29 countries in Europe, North America, and Asia Pacific from September 2014 to July 2015."|There was no separate randomization in this study; each participant received their assigned treatment per Protocol 20110118. Data were analyzed according to Study 20110118 randomized treatment arm.
724323|NCT02207621|62 clinical trial sites participated in this study, of which 60 clinical trial sites enrolled participants. Screening started in June 2014. Enrollment started in July 2014. The last participant was enrolled in March 2015.|Prior to enrollment, adult participants were required to have a Screening Visit and 2 Qualification Visits to allow for washout of ocular hypotensive medication.
724324|NCT02207608||
724325|NCT02207569||
724326|NCT02207556|Subjects were stratified by the type of amyloidosis. Subjects with primarily organ-based disease were classified as Localized Disease), whereas subjects with hematologic disease were classified as Systematic Disease. Each population received the same intervention but assessment of the clinical outcomes used different classification categories.|
724327|NCT02207530|110 sites in 14 countries enrolled and screened patients. The study was conducted and managed by PRA, a contract research organization.|
724328|NCT02207491|Participants were recruited at 35 clinical trial sites starting in June of 2014. The first participant was enrolled in July of 2014 and the last participant was enrolled in December of 2014.|"Prior to enrollment, adult participants were to have a Screening Visit and 2 Qualification Visits to allow for washout of ocular hypotensive medication if needed.
~The Randomized Population includes all subjects who were randomized to treatment. Baseline variables and demographic characteristics were summarized for this population."
724329|NCT02207478||
724330|NCT02207413|Primed subjects: Received 2 doses of seasonal influenza vaccine separated by at least one month during the last season or had received at least 1 dose prior to last season. Unprimed subjects: Did not receive any seasonal influenza vaccine in the past or received only 1 dose for the first time in the last influenza season.|"For 5 subjects, study vaccine dose not administered at all but subject number was allocated.
~Some data has been analysed in sub-groups by age: 3-4 years, 5-17 years, 6 months to <5 years."
724331|NCT02207400|The participants were recruited at a clinical site in the USA.|
724332|NCT02207374|The trial was conducted at 41 sites in Japan.|Subjects were either on diet and exercise therapy only or on stable treatment on oral anti-diabetic drugs (OADs) mono-therapy [either of sulphonyl urea (SU), glinide, alpha-glucosidase inhibitor (α-GI) or thiazolidinediones (TZD)] within approved Japanese labelling in addition to diet and exercise therapy before week -2.
724333|NCT02207322||
724334|NCT02207244||Results are reported through Week 48. Complete data through Week 264 will be reported within 1 year of end of study trial date when final data based on study completion date will be available.
724335|NCT02207231||Results are reported through Week 48. Complete data through Week 264 will be reported within 1 year of end of study trial date when final data based on study completion date will be available.
724336|NCT02207088||The intent-to-treat (ITT) population consisted of all enrolled participants who received at least 1 dose of study drug.
724337|NCT02206828||
724338|NCT02206776||
724339|NCT02206620||
724340|NCT02206607||Prior to being enrolled in the 4 period crossover, participants were required to complete an open-label, sponsor-provided metformin period. 42 participants started the metformin period and of those 42 participants, 39 were enrolled in the 4 period crossover and received at least 1 dose PF-04937319.
724341|NCT02206217||
724342|NCT02206152||Crossover design
724343|NCT02205983||Participants were excluded if they had a serious medical condition, abnormal electrocardiogram, Axis I psychiatric disorder in the past year, or a history of psychosis. Subjects were also excluded if they had not completed high school, were not fluent in English, worked a night shift, used hormonal contraceptives, or were pregnant.
724344|NCT02205814|"The first patient was screened on 28th April 2014. The first patient was randomised on 6th May 2014. The last patient completed the study on 6th January 2015.
~The study was conducted in 25 study sites in Czech Republic, Germany, Italy and US."|A total of 645 patients entered a 2-week Screening period (including wash out); 209 of them were screen failed. One patient randomised to PLACEBO did not receive the study treatment (counted for ITT but not in safety population). Five patients received the study treatment without randomisation (not counted for ITT, but in safety population).
724345|NCT02205801||
724346|NCT02205476|Participants who received the treatment in previous study B5301001 (NCT01730339), were enrolled in this study.|Participants who completed part A of the study had the option to obtain scar revision surgery with PF-06473871 in part B of the study. No participant entered into part B due to premature termination of the study.
724347|NCT02205333|A total of 58 participants were screened at 13 sites in the United States of America (USA).|A total of 58 participants were screened for this study, of which 48 participants were enrolled and received study treatment.
724348|NCT02205307||
724349|NCT02205177||
724350|NCT02204982||
724425|NCT02200211|"Two separate sub-studies based on age at enrollment
~Younger Cohort defined as 5 to <13 years of age Older Cohort defined as 13 to <17 years of age"|
724426|NCT02200055||
724427|NCT02200042||
724351|NCT02204917|From September 2014 to April 2015, the study team recruited and enrolled 31 eligible subjects scheduled for the clinically indicated voiding cysteourethrography (VCUG) examination from the daily inpatients/outpatients program of the Radiology Department at the Children's Hospital of Philadelphia.|One subject was enrolled into the study (informed consent signed), however, sedation was required as standard of care to perform the clinically indicated VCUG examination. Sedation constitutes an exclusion criterion. Therefore, this subject although enrolled into the study, did not actually complete it.
724352|NCT02204761||
724353|NCT02204748||
724354|NCT02204657|"50 women with insulin-requiring gestational diabetes enrolled from the University of Malaya Medical CentreAntenatal Clinic between April 2013 to April 2015.
~Women with overt diabetes or pregestational diabetes were excluded."|
724355|NCT02204579||
724356|NCT02204566||
724357|NCT02204449||
724358|NCT02204410|IRB-approved flyers were posted in the general community and throughout Massachusetts General Hospital between June 2014 and April 2016.|
724359|NCT02204371|This study was planned as a two part study (Part A and Part B). As efficacy based dose escalation stopping criteria was met, there was only one dose cohort (50 milligrams [mg] once daily cohort) in Part A. The study was stopped prior to Part B being conducted.|Run-in period started at the screening visit or up to 2 weeks after the screening visit. Participants (par.) were stabilized on a anemia management plan for 4-8 weeks prior to the first dose. Unstable par. were allowed to continue in the run-in period for additional 4 weeks. 2 par. did not met the eligibility criteria.
724360|NCT02204319||
724361|NCT02204293|Participants with adult-onset Still's disease (AOSD) took part in the study from June 21, 2012 to May 5, 2018 at 14 investigative sites located in Germany to participate in two double-blind parts - Part I (Up to Week 12) and Part II (Up to Week 24) and one open-label Long-Term Extension (LTE) phase (Up to Month 27).|A total of 36 participants entered in Part I to receive canakinumab/placebo. Out of 31, 5 participants from canakinumab arm, and 3 from placebo arm did not enter Part II, 23 participants entered Part II and received canakinumab or placebo up to Week 24. 7 participants who achieved clinical remission entered LTE Phase to receive canakinumab.
724362|NCT02204176||
724363|NCT02204150||In this feasibility study we try to establish the overall number of participants who are able to swallow the capsule and provide us with quality imaging using this new technology. At this point we do no distinguish tolerability separately in each of the three groups and are treating them as one.
724364|NCT02204124|The study opened to participant enrollment on 01/01/2015 and closed to participant enrollment on 08/09/2017.|There were 44 enrolled to the study. 12 were enrolled but were not randomized to an arm and did not start the study due to reasons such as ineligibility, physician discretion, and because the Thunderbeat was not in the operating room.
724365|NCT02204007||
724366|NCT02203916|Participants took part in the study at 29 investigative sites in Korea from 12 July 2014 to 03 February 2016.|Participants with a diagnosis of essential hypertension were randomized at a ratio of 2:2:1 into 1 of 3 treatment groups, once a day azilsartan medoxomil 40 mg, 80 mg or placebo. One participant in the 80 mg group was randomized twice, counted once in the randomized set, and is excluded from the Full Analysis Set and Safety Analysis Set.
724367|NCT02203851|Analyses were performed using the intent-to-treat (ITT) population defined as all participants who received at least 1 dose of study drug. As predefined, the demographics, disposition and safety results were summarized for ITT population. Efficacy results were summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).|Participants completing lead-in study and met eligibility for this study were enrolled; demographic/disposition were not collected by dose level. Some participants in extension study had dose escalation due to lack of efficacy, predefined selected safety analysis were broken down by groups: participants remaining at 90mg and those receiving 180mg.
724368|NCT02203838||"A total of 820 subjects were screened for study participation at 53 sites in the US.
~Overall, 500 participants were included in the Safety Population: 92 rollover participants and 408 de novo participants."
724369|NCT02203786|Recruitment was conducted for all groups between January 2010 and May 2015|Pathological Gamblers and healthy Controls were each randomized to receive Haloperidol or Fluphenazine. In each group, treatment sequence (antagonist first, placebo second; or vice versa) was counterbalanced across participants, to control for order effects only (sequence was not a test factor). Two Haloperidol-Controls dropped out after session 1.
724370|NCT02203747||
724371|NCT02203721|Beginning August 27, 2014, a total of 324 subjects were enrolled (consented) in the study and 299 of these subjects were implanted with a study lens in at least one operative eye between September 16, 2014, and February 10, 2015, across 15 U.S. clinical sites.|A total of 23 subjects were consented but were not assigned to a group due to failure to meet inclusion/exclusion criteria, withdrawn consent, non-ocular health, or lost-to-follow-up.
724372|NCT02203630||
724373|NCT02203591||"This is a randomized, paired comparison design where each subject received 2 of the planned treatments, 1 on the left side & 1 on the right. Each subject provided 2 abdomen test sties, left & right and/or 2 inguen test sites, left & right.
~569 subjects were randomized for the abdomen region & 404 subjects randomized for the inguen region resulting in 738 subjects providing 1946 applications of test products on 2 anatomical regions."
724374|NCT02203578|Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 11/20/2014 and was closed by the Principal Investigator on 6/14/2016 due to slow accrual.|We are reporting results on 1 eligible participant.
724375|NCT02203565||
724376|NCT02203357||
724377|NCT02203331|Study was conducted in fourteen countries in Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Germany, Japan, Netherlands, Norway, Poland, Spain, Switzerland, United States, between 16 October 2014 (first participant first visit) and 24 October 2016 (last participant last visit).|Overall, 605 participants were screened, of them 286 failed screening, remaining 319 participants were randomized and allocated to treatment, of them 14 participants did not receive study treatment for various reasons, remaining 305 participants were treated and 272 participants completed study treatment.
724378|NCT02203162||
724379|NCT02203149||Of 432 screened, 63 were enrolled and randomized to Part 1 and 336 were enrolled and randomized to Part 2, for a total of 399 randomized.
724380|NCT02203071||6 Subjects were intra-operative screen failures.
724386|NCT02202785|Participants took part in the study at 26 investigative sites in Belgium, Spain, United Kingdom and the United States from 24 September 2014 to 15 January 2016.|Participants with a diagnosis of Pancreatic adenocarcinoma were enrolled in 1 treatment group, MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle.
724387|NCT02202759|Participants took part in the study at 24 investigative sites in Belgium, Spain, United Kingdom and the United States from 04 August 2014 to 15 January 2016.|Participants with a diagnosis of metastatic or recurrent adenocarcinoma of the stomach or gastroesophageal junction expressing Guanylyl Cyclase C (GCC) were enrolled in 1 treatment group, MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle.
724388|NCT02202746|178 patients were recruited from 32 sites in the United States.|
724389|NCT02202616||
724390|NCT02202551||
724391|NCT02202538|Subjects were screened and enrolled at five sites in the United States|
724392|NCT02202499|Daily cigarette smokers were recruited from the community for a smoking cessation intervention study, from July 2014 through August 2015, by Moffitt Cancer Center in Tampa, Florida.|86 interested parties were consented, 1 later declined, 23 did not meet criteria. 62 were eligible, 3 discontinued due to factors unrelated to study, 1 failed to attend first assessment. 58 parties participated in the study.
724393|NCT02202434|"912 subjects randomized from 22Sep2014 to 24Dec2015. 102 subjects enrolled in the Roll-in cohort. 295 subjects enrolled in the US CAS from 25Feb2016 to 23Feb2017. Enrollment in the LOTUS Edge Valve System - Single-arm Edge Nested Reg is ongoing.
~Enrollment in the LOTUS Edge Valve System - Single-arm 29mm Reg and Roll-in Cohorts has not begun."|"The non-randomized Roll-In phase with only the test device was for centers with no previous experience implanting the Lotus Valve System. Each performed at least two Roll-In cases before starting RCT.
~Only cohorts that have completed enrollment, reached primary endpoint and were submitted for regulatory approval are included in the Results Section"
724394|NCT02202317||
724395|NCT02202252|The recruitment period: July 2014-february 2015 Location: Dıskapi Research and training Hospital General Surgery Clinic|
724396|NCT02202161|The study was conducted from 27 August 2014 to 30 January 2015. After interim analysis of safety, tolerability, pharmacodynamic and/or pharmacokinetic (PK) data, GSK2330672 10 and 20 milligram (mg) doses were dropped and GSK2330672 60 mg was added.|A total of 187 participants were screened, of these, 112 were screen failures and 75 entered the run-in period. Five participants were withdrawn prior to taking a metformin dose in the 14 days of run-in period. A total of 64 participants were randomized to receive investigational product, as 6 participants were withdrawn prior to randomization.
724397|NCT02202135|Overall, 4 patients were enrolled from 2 centres in 1 regions in this study. The first patient was enrolled on 15 September 2014 and the last patient last visit was on 02 January 2015.|
724398|NCT02202109||
724399|NCT02202044||The study was terminated before participants finished treatment and the PI is no longer in the institution to provide information for results reporting. No results information is available.
724400|NCT02202031||
724401|NCT02201953|Participants were enrolled at study sites in Australia, North America, Europe, and New Zealand. The first participant was screened on 14 July 2014. The last study visit occurred on 15 December 2015.|652 participants were screened.
724402|NCT02201940|Participants were enrolled at study sites in the United States, Canada, Europe, and Asia. The first participant was screened on 18 July 2014. The last study visit occurred on 23 September 2015.|847 participants were screened.
724403|NCT02201901|Participants were enrolled at a total of 47 study sites in the United States. The first participant was screened on 31 July 2014. The last study visit occurred on 25 November 2015.|438 participants were screened.
724404|NCT02201784|jawaharlal nehru medical college and hospital|Patients who met any of the exclusion criteria or those who did not gave consent were excluded.
724405|NCT02201771||
724406|NCT02201524||
724407|NCT02201472||
724408|NCT02201446||
724409|NCT02201420||
724410|NCT02201394||
724411|NCT02201329||
724412|NCT02201290|A total of 9 patients received Eltrombapag treatment during the extension study. Four patients (44.4%) completed the study while 5 patients (55.6%) discontinued from treatment and withdrew from the study.|
724413|NCT02201277|From April 2014-May 2016, patients coming to University of California, San Francisco Interventional Radiology (IR) with a MD referral for an Inferior Vena Cava (IVC) filter were invited to join a study of two FDA approved filters. After informed consent, subjects were randomized 1:1 to receive either a Denali or Option Elite filter.|
724414|NCT02201212||
724415|NCT02201108|Study was conducted at 57 active centers in 21 countries. A total of 185 participants were screened between 16 July 2014 and 27 December 2017, of which 166 participants were enrolled and randomized. A total of 19 participants failed screening mainly due to meeting exclusion criteria.|Participants were randomly assigned to receive either teriflunomide or placebo in a 2:1 ratio (109 teriflunomide and 57 placebo) via Interactive Voice Response System. Randomization was stratified by the country and participant's pubertal status. Data reported based on the primary completion date of 25 October 2019.
724416|NCT02201056|Participants took part in the study at 1 investigative site in the United States from 09 July 2014 to 30 July 2015.|Healthy Volunteers were enrolled in 1 of 7 treatment groups, once a day placebo, TAK 935 15 mg, 50 mg, 200 mg, 600 mg, 900 mg or 1350 mg.
724417|NCT02200770|The study was conducted in 24 countries.|A total of 467 participants were screened in the study, out of which 236 were screen failures. A total of 231 participants were randomized in this study. The results of this study are posted per the data of primary completion date (26Oct2018).
724418|NCT02200614|Study was conducted at multiple centers in 36 countries between 12 September 2014 (first participant first visit) and 15 November 2019 (cut-off date).|From 2696 participants who signed informed consent, 1187 participants were discontinued from screening. A total of 1509 participants were randomly assigned to either darolutamide arm or placebo arm. The study was unblinded on 30 OCT 2018 and participants in the placebo arm could cross over to open-label darolutamide treatment.
724419|NCT02200536||
724420|NCT02200523||
724421|NCT02200510||
724422|NCT02200458||
724423|NCT02200445||
724424|NCT02200328||
732811|NCT01609348||
724431|NCT02199691|Study participants were enrolled in 40 centers in the Unites States (US) from 22 July 2014 to 25 February 2015.|A total of 1715 participants were enrolled and randomized in the study.
724432|NCT02199652||
724433|NCT02199574||
724434|NCT02199509|Participants between the ages of 18 and 80 with a diagnosis of primary oromandibular or cranial dystonia were recruited from the Movement Disorders and Botulinum Toxin Clinics at the National Institutes of Health and from the Dystonia Global Registry and Dystonia Medical Research Foundation.|Subjects were excluded if they had a history of depression, psychosis or phobic disorders. One subject was consented but did not participate due to abnormal laboratory finding noted during screening.
724435|NCT02199496||
724436|NCT02199314|Participants were enrolled in Orthopaedics clinic during scheduled visit for pre-surgical planning. Parents/guardians were given the informed consent and participant were given assent documents. Anyone who agreed to participate at this time was considered enrolled for the purposes of the study. This number was 30.|There was no group assignment - each participant was to be his/her own control.
724437|NCT02199197||
724438|NCT02199080||
724439|NCT02199041|Twelve participants meeting eligibility criteria and 12 of their blood donors were enrolled at St. Jude Children's Research Hospital between July 2014 and January 2015.|The 12 enrolled blood donors did not undergo transplantation and are therefore not included in the results reported here.
724440|NCT02199028|A total of 30 subjects with Type 1 diabetes between 12-45 years were enrolled at 2 academic medical centers. 28 subjects completed the full 4 weeks of the study. 2 subjects discontinued for the study early. The last subject completed in March 2015.|
724441|NCT02198963|Subjects were recruited and screened at a single US center|
724442|NCT02198833||
724443|NCT02198651||All Lead-in-Treated Subject population: participants who were enrolled in the study and received at least 1 dose of study drug during the Lead-in period. Three participants enrolled in the study but were not treated during the Lead-in period.
724444|NCT02198430||
724445|NCT02198235||
724446|NCT02198040|27 patients Hemophilia of the Association of Murcia were recruited between January to October 2013|28 patients who met the exclusion criteria. Only one declined to participate for personal reasons.
724447|NCT02197806||
724448|NCT02197767||
724449|NCT02197572|Participants took part in the study at 5 investigative sites in the United States from 15 Sep 2014 to 28 Feb 2019.|Participants who had advanced solid tumors were enrolled to receive sapanisertib 40 mg on Day 1. Participants then received sapanisertib 30 mg once weekly (QW) until they experienced disease progression or unacceptable sapanisertib-related toxicity or withdrawal of consent or for up to 12 months (whichever occurred first).
724450|NCT02197520||
724451|NCT02197481|Eligibility criteria included scheduled liver resection for benign or malignant hepatobiliary disease and a minimum age of 18 years.|Patients undergoing concomitant vascular resection or bile duct resection and those undergoing emergency liver resection were excluded.
724452|NCT02197455||
724453|NCT02197416|This open label, single arm prospective cohort study was designed to assess the safety of dabigatran etexilate (DE) for secondary prevention of paediatric venous thromboembolism (VTE) with 12-month (365 days) treatment period followed by 28 days end of treatment follow-up. Results of participants were reported via 3 mutually exclusive age groups.|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. 1 enrolled subject was withdrawn before treated due to unable to swallow the capsules.
724454|NCT02197377||
724455|NCT02197273|Recruitment period July 1, 2014 to September 30, 2015 for patients undergoing total hip, knee or shoulder arthroplasty at OhioHealth Riverside Methodist Hospital.|Patients were randomized in a one to one fashion to one of two study groups within each surgical group. 10 patients were excluded after enrollment due to dual enrollment in another study, changes in anesthesia plan or improper dose of study drug. These 10 patients were not included in the analysis.
724456|NCT02197247|First patient enrolled: 04 December 2014; Last Subject Last Visit Part A: 09 July 2015 and Part B: 29 June 2016. Study performed at 18 sites across Asia, North America and Western Europe. Part A assessed effect of multiple doses of rifampicin on PK of AZD9291; Part B allowed subjects further access to AZD9291 and provided additional safety data.|51 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 10 subjects were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 41 patients started Period 1 and received treatment.
724457|NCT02197234|First patient enrolled: 22 December 2014; Last Subject Last Visit Part A: 30 April 2015 and Part B: 13 May 2016. Study performed at 17 sites across Asia, North America and Western Europe. Part A assessed effect of multiple doses of AZD9291 on PK of simvastatin; Part B allowed subjects further access to AZD9291 and provided additional safety data.|57 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 5 patients were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 52 patients started Period 1 and received treatment.
724458|NCT02197130||A total of 272 subjects (133 males and 139 females) were randomized and assigned study treatment.
724459|NCT02197078|From Clinformatics and MarketScan source data, patients with a recorded diagnosis of type 2 diabetes mellitus (T2DM) who initiated linagliptin, sitagliptin, saxagliptin, alogliptin, pioglitazone, or 2nd generation sulfonylureas were identified between May 2011 and December 2016.|Only participants with no use of a medication in the same class or comparator class during the 6 months prior to index date, who were at least 18 years of age and enrolled for a minimum of 6 months in the data source before treatment initiation were included.
724460|NCT02197065||
724461|NCT02196922||
724462|NCT02196857|Recruitment Period: February 2015 - February 2018|
724463|NCT02196831||1 subject was randomized to tesamorelin but self-discontinued during the baseline visit, prior to receiving any study drug. This individual is included in baseline characteristics but is not counted as starting tesamorelin (hence the discrepancy between 61 total enrolled and the 30 in tesamorelin and 30 in placebo group shown in participant flow).
724464|NCT02196766||
724465|NCT02196714|Conducted at 1 site from July 2014 - September 2014. Study duration for each subject was between 33 and 98 days.|Study was four-period, four-treatment, complete cross-over design in healthy adult Japanese Subjects. Each treatment visit was followed by a minimum 7 day to maximum 14 day washout period between treatments.
724466|NCT02196701|This single-arm, open-label longitudinal study was conducted at 12 sites in Canada from 5 August 2014 to 17 March 2017. The study entailed a screening period up to 35 days, a 24-week treatment period, and a 70-day safety follow-up period. Participants continued to receive adalimumab (ADA) and had oral methotrexate (MTX) added to their treatment.|This study enrolled participants who in the opinion of the Investigator were not responding optimally to adalimumab monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) or who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders).
724467|NCT02196688||
724468|NCT02196675|Individuals undergoing VATS lobectomy for suspected or confirmed Non-small Cell Lung Cancer, or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of Care, and who meet study entry criteria, were enrolled in this study.|There was no assignment to treatment group given that this is a single arm study wherein the same device was used on all subjects. Results are presented for the overall cohort as well as by the individual procedure performed - lobectomy, wedge resection, or wedge resection with lobectomy.
724469|NCT02196558|Participants took part in the study at 13 investigative sites in Japan from 26 May 2014 to 13 July 2017. As planned separate pharmacokinetics (PK) parameters are not reported and PK analyses was performed for serum E6011 concentrations. Also as planned, combined data for Treatment Phase and Expansion Phase is reported.|Total 53 participants were enrolled and screened, of which 16 were screen failures, 37 participants received study drug in 12-week Treatment Phase. Out of them, 32 participants completed 12-week Treatment Phase. Of 32 participants, 28 participants entered Extension Phase, 22 completed 40-week Extension Phase. '>='signifies greater than or equal to.
724470|NCT02196506|This trial was conducted in 837 participants at 51 trial sites in the following 5 countries:Germany,Hungary,Poland,Slovakia,andUnited States (US).A total of 1144 participants with major depressive disorder were screened for the trial, 837 enrolled into Phase A,394 were randomized into Phase B and 322 continued treatment with placebo+ADT in Phase A+|Trial consisted of a screening phase and 3 phases. In phase A (8-week single-blind prospective treatment phase) and in phase A+ (Single-blind phase A Responder), there was single treatment group. In phase B (6-week double-blind randomization phase), there were 2 treatment groups. All Outcome Measures were assessed in phase B.
724471|NCT02196259||3 participants were screened out.
724472|NCT02196168||
724473|NCT02196077|This study was conducted at 20 sites in the United States from August 2014 to March 2015. Study participation was a maximum of 28 days.|A Randomized, Double-Blind, Chronic Dosing (28 Days), Four-Period, Five-Treatment, Incomplete Block, Multi-Center, Crossover Study. Subjects completed final visit procedures. Final telephone follow-up occurred between 7 to 14 days from Visit 13. By-sequence tabulations of the data were not pre-specified.
724474|NCT02195986||
724475|NCT02195895||
724476|NCT02195869||
724477|NCT02195713||
724478|NCT02195700||202 patients were screened and gave informed consent to enter the study. 85 were either ineligible for entry into the study or declined study participation. The most common reason for ineligibility (49 patients) was insufficient TD severity as assessed with Abnormal Involuntary Movement Scale (AIMS). 117 patients were randomized.
724479|NCT02195687||The participant flow reflects the Safety Population, which includes all randomized subjects who received at least 1 study drug injection.
724480|NCT02195622||
724481|NCT02195583|Participants were recruited at one clinical study site in the USA.|A total of 64 participants were screened and 62 were randomized.
724482|NCT02195531||
724483|NCT02195518|This study was conducted to evaluate the efficacy and safety of Tenofovir Disoproxil Fumarate treatment in Chinese chronic hepatitis B (CHB) participants following failure of multiple Nucleos(t)ide analogues(NAs) at different centers in China.|A total of 281 participants were screened; of these 68 were screen failures. A total of 213 participants entered the treatment phase of the study.
724484|NCT02195479||Results are reported up to second interim analysis (up to 2.4 years). Complete data through 6.4 years will be reported within 1 year of end of study trial date when final data based on study completion date will be available.
724485|NCT02195427|"A total of 148 subjects were randomized to RHA Global Action (GA)/Juvederm (J) (n=74), RHA Deep Lines (DL)/Juvederm (J) (n=74).
~26 subjects were randomized to an untreated group (recruited only to avoid Blinded Live Evaluator to be biased so, not presented)"|One subject randomized to the RHA GA/J withdrew consent prior to receiving initial treatment reducing the population for this cohort to n=73.
724486|NCT02195414|Subjects enrolled into this trial were comprised of male and female subjects from the general interventional cardiology population. The study commenced on June 19, 2014 with the first subject enrolled on this date. The last subject was enrolled September 3, 2014.|
724487|NCT02195349|This is a single ascending dose study conducted in healthy volunteers and participants with plaque psoriasis. Participants were enrolled in Germany and the United Kingdom from 30 July 2014 to 07 March 2018.|A total of 330 participants were screened in healthy volunteer cohorts and 197 participants in psoriasis cohorts of which 290 were screen failures in healthy volunteer cohorts and 170 in psoriasis cohorts. A total of 40 participants were enrolled in healthy cohorts and 27 in psoriasis cohorts.
724488|NCT02195310||
724489|NCT02195232||
724490|NCT02195011|Between July 2014 and February 2017, 26 patients with metastatic colorectal cancer (mCRC) with liver metastases were enrolled. The study was closed early due to slow enrollment.|
724491|NCT02194998|Participants were enrolled from September 2015 to December 2016 at 16 U.S. sites.|There was no randomization in this study. Participants were stratified according to evidence of cirrhosis (yes versus no). The enrollment to the strata level for cirrhosis=yes was limited to no more than 30% within any particular study cohort.
724492|NCT02194985||
724572|NCT02186873||Of the 312 participants screened, 208 participants were randomized (105 to golimumab 2 milligram per kilogram [mg/kg] and 103 to placebo group) and treated.
724573|NCT02186847||
732812|NCT01609296||
724493|NCT02194933|The study was conducted in the United States (US). 38 participants with schizophrenia with impulsivity were enrolled (signed informed consent) and randomized (1:1): 19 participants to brexpiprazole 2mg and 4mg treatment each; received at least 1 dose of Investigational medicinal product (IMP) for 6-week treatment phase in a double-blind design.|Participants had pretreatment screening phase from 2 to 21 days to assess eligibility criteria, complete screening assessments & to wash out from prior antipsychotic drugs & any other prohibited concomitant drugs; participants were followed for safety by clinic visits/telephone (after first 3 to 4 days of antipsychotic washout & weekly as needed).
724494|NCT02194699|"First patient enrolled: 30 Oct 2014; Last Patient Last Visit: 21 Sep 2017. Study performed at 242 sites in 13 countries.
~Patients were maintained on their currently prescribed inhaled corticosteroid long-acting β2-agonist therapy and any additional maintenance asthma controller medications throughout the study period."|"1696 patients signed informed consent, 1163 entered screening/run-in period, 856 patients were randomised to receive investigational product (IP) and 849 received treatment.
~The primary population was the biomarker positive population, defined as all patients with baseline fractional exhaled nitric oxide (FeNO) ≥37 parts per billion (ppb)."
724495|NCT02194621|subject recruitment is completed locally at the clinical site|There will be a one (1) week wash out phase with commercially available fluoride toothpaste prior to any study intervention being assigned.
724496|NCT02194465||Participants entered at lead-in for wash out and a placebo run-in period prior to randomization.
724497|NCT02194088||
724498|NCT02194062||
724499|NCT02193880||
724500|NCT02193867|A total of 6 sites were initiated, and participants were treated at 5 sites in 4 countries (United Kingdom [UK], United States [US], Finland, Italy). One study site in the US was initiated but did not screen or treat any participants.|The study consisted of a screening period of up to 3 weeks. Participants who met all eligibility criteria were enrolled, treated, and analyzed.
724501|NCT02193828||
724502|NCT02193815||This trial enrolled participants with chronic plaque type psoriasis and with a treatment area sufficient for 6 treatment fields on 1 to 3 comparable plaques defined as having treatment fields with psoriatic skin thickness/Echo-Poor Band (EPB) of at least 200 micrometers.
724503|NCT02193776|This trial was conducted at 10 centers in 3 countries (South Africa, Tanzania, and Uganda) from 23 October 2014. Adult male and female participants with drug-sensitive (DS) or multi-drug resistant (MDR) smear-positive pulmonary tuberculosis (TB) were recruited into this open-label multi-center study.|Participants were confirmed positive for M.tuberculosis on molecular test. DS-TB participants were to be sensitive to rifampicin and newly diagnosed with pulmonary TB (or untreated for at least 3 years). MDR-TB participants were to be resistant to rifampicin, sensitive to moxifloxacin and newly diagnosed with pulmonary TB (or treated for <=7 days).
724504|NCT02193490|This single-center study was conducted at the Department of Ophthalmology Clinical Trials and Translational Center, the University of Illinois at Chicago (UIC).|A 2-week washout period was required if topical corticosteroids or topical cyclosporine were discontinued before enrollment.
724505|NCT02193178||
724506|NCT02193165|recruitment at clinical site|There is no wash-out period prior to product randomization and distribution. Each subject was randomized and given a study treatment to follow after successfully completing the study screening procedures.
724507|NCT02193152||
724508|NCT02193087|Participants took part in the study at 7 investigative sites in the United States from 22 July 2014 to 19 May 2015.|Healthy volunteers were enrolled in a 2:1:1:6 ratio into 1 of 4 study groups: 1 study group received 1 dose and 3 study groups received 2 doses.
724509|NCT02193074||Of the 149 participants screened, 27 were screening failures. A total of 122 participants enrolled and were randomized; 1 participant withdrew prior to receiving treatment.
724510|NCT02192905||In order to begin the intervention, participants needed to complete: an online eligibility screener, a telephone screening, the consent process, a screening survey, medical clearance, and a webinar. Missing any of these components would be reason for exclusion.
724511|NCT02192879||
724512|NCT02192814|This multicenter, open-label study started recruiting in June 2014.|Participant Flow refers to the Safety Set (SS), consisting of all enrolled subjects who received at least 1 infusion of iv LCM.
724513|NCT02192775||
724514|NCT02192684|Recruitment Dates: July 10 2010 - March 2014|
724515|NCT02192606||
724516|NCT02192541||The escalation of dose was not performed as planned for this study due to toxicity and early termination of the trial.
724517|NCT02192307||
724518|NCT02192190||
724519|NCT02192164||
724520|NCT02192099||Outpatients who have completed 8 or more weeks of treatment in the preceding study (GLYX13-C-202) and were willing to continue treatment with rapastinel (GLYX-13). Patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg.
724521|NCT02191865|Healthy subjects were to be matched to subjects with hepatic impairment ((Child-Pugh A, score 5 or 6),(Child-Pugh B, score 7 to 9)) by age (±10 years), body weight (±10%), sex, race, and smoking habits (current vs. ex- and never smokers).|
724522|NCT02191618||
724523|NCT02191605||
724524|NCT02191579||
724525|NCT02191397|This was a multi-center, randomized, double-blind, parallel active-controlled study to evaluate the efficacy, safety and tolerability of bupropion hydrochloride extended-release (XL) and escitalopram oxalate in participants with major depressive disorder. This study was conducted in China from 10-February-2015 to 25-October-2016.|The study had screening phase (up to 14 days), 8-week double blind treatment phase and taper phase (up to 1 week). A total of 655 participants were screened and 538 were randomized into the study. 4 participants were randomized but discontinued prior to receiving any study treatment. Hence, the Safety Population was comprised of 534 participants.
724526|NCT02191267|24 subjects at presumed risk for Chronic Traumatic Encephalopathy (CTE), 6 healthy control subjects without a history of repetitive brain trauma, and 4 Alzheimer's Disease (AD) subjects were recruited from the Boston University Center for the study of Chronic Traumatic Encephalopathy.|Subjects were pre-assigned according to previously assigned study diagnostic status based on prior participation in studies at the Boston Center for the study of Chronic Traumatic Encephalopathy.
724606|NCT02184169||
733004|NCT01597791||
724527|NCT02191137|A total of 97 patients signed informed consent; 22 patients did not complete screening (20 patients were screen failures and 2 patients withdrew from the study). Of 75 patients who received therapy with riociguat, 65 patients completed study treatment and entered follow-up, and 60 patients completed the study.|
724528|NCT02191046|we enrolled sinusitis patient age 3-15 year during March 2013 - May 2014. We excluded patients with a history of penicillin allergy, nasal anatomic defects, immunodeficiency or had complication from sinusitis. Patient with low compliance defined as the rate usage nasal irrigation estimated at less than 80% were excluded|
724529|NCT02191033|Recruitment open from January 2015 to May 2016. Recruited from local college campuses.|
724530|NCT02190903||A total of 15 patients provided informed consent for participation; 3 were withdrawn from the study prior to randomization. 2 of these patients were withdrawn due to ineligibility; 1 was withdrawn due to other reasons.
724531|NCT02190747|Eight subjects were randomized 3:1 to either palovarotene or placebo in Cohort 1; 8 additional subjects were randomized 3:1 in an interim period between Cohorts 1 and 2. In Cohort 2, 24 additional fibrodysplasia ossificans progressiva (FOP) subjects were randomized 3:3:2 across 2 weight-based regimens of palovarotene or placebo.|The study included clinically diagnosed FOP subjects at least 6 years of age (Cohort 2) or 15 years of age and older (Cohort 1) with symptomatic onset of a flare-up within 7 days of treatment start and accessible for treatment and follow-up.
724532|NCT02190721|A total of 55 patients were screened for this study. Of the 55 patients screened, 50 patients at 33 investigational centers in Central and Eastern Europe met inclusion/exclusion criteria and were considered to be eligible for enrollment into the study.|Of the 5 patients who were not enrolled, 2 patients were excluded due to inclusion criteria not met (baseline AST elevation, baseline ANC count was too low), 2 patients were excluded due to exclusion criteria not met (ongoing active infection or history of infectious disease within 2 weeks prior to screening), and 1 patient withdrew consent.
724533|NCT02190604|For Cohort 6 continuing into the food effect part of the study the subjects remained on the same treatment assignment that was required during the fed state. Therefore no randomization f the subject occurred during the food effect arm. Only 5 of the 6 subjects went into the fed cohort.|In parts 1 and 2, participants (Healthy Volunteers) were randomized 3:1 to receive QBW251X or placebo. In part 3, participants (cystic fibrosis (CF) patients) were randomized 3:1 to receive QBW251X or placebo.
724534|NCT02190591|204 patients were enrolled between 5/22/2014 and 12/23/2014|
724535|NCT02190552||
724536|NCT02190435||
724537|NCT02190279||
724538|NCT02190045||
724539|NCT02189954||
724540|NCT02189941|Subjects were dosed at the clinic between May and June of 2014|Subjects were randomized to receive 3 single-dose treatments in different sequences, with a washout of 7 days between doses. Twenty (20) subjects were screened and 12 were randomized. One subject experienced a medical event prior to the first dosing and was excluded from the study, so only 11 subjects received at least 1 dose of study product.
724541|NCT02189915||
724542|NCT02189889||
724543|NCT02189863|Subjects were recruited from 2 investigational sites located in the UK.|Of the 33 enrolled, 6 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who successfully tried at least one study lens (27).
724544|NCT02189837|This study was conducted at 2 centers in Australia. The first participant was enrolled on 08 July 2014, and the last participant enrolled on 15 December 2014.|Participants who met eligibility criteria underwent an initial 4 week run-in period of dietary stabilization before randomization. Randomization was stratified based on screening low-density lipoprotein (LDL-C) concentration (< 130 mg/dL vs ≥ 130 mg/dL)
724545|NCT02189759||
724546|NCT02189668||
724547|NCT02189629||
724548|NCT02189473||
724549|NCT02189382||
724550|NCT02189317|Participants were recruited from an ambulatory surgery center from July 2014 to March 2015.|Of the fifty participants who consented for the study, 18 participants who had different graph types were excluded to avoid a potential confounder. Thirty two participants were included in the overall study who had identical graph types.
724551|NCT02189252|The study subjects were recruited at 6 sites. In total, 30 subjects were screened, of which 15 were randomized to 1 of 4 treatment sequences.|No applicable
724552|NCT02189161||
724553|NCT02189122||Twenty-five enrolled participants were excluded prior to randomization to study group because they did not meet inclusion or exclusion criteria.
724554|NCT02188849||
724555|NCT02188784||
724556|NCT02188719||
724557|NCT02188589||
724558|NCT02188576|The recruitment locations were the preoperative clinics at Boston Children's Hospital (Boston, MA) and Gaslini Children's Hospital (Genoa, Italy) from 2014 to 2017.|
724559|NCT02187887||
724560|NCT02187861||
724561|NCT02187809||
724562|NCT02187783||There were 176 patients screened
724563|NCT02187744||A single participant was randomized but not treated; this participant was included in the ITT population, but not in the Participant Flow, Per Protocol, or Safety populations.
724564|NCT02187471|A total of 2526 participants who met all inclusion criteria and no exclusion criteria were enrolled from 16 Jan 2015 to 12 Jan 2017 at 182 sites. Of the 2526 participants enrolled, 1301 were randomized to treatment.|Eligible participants were randomized 1:1:1:1 to either DS-5565 15 mg every day (QD) given orally, DS-5565 15 mg twice daily (BID) given orally, placebo given orally as pregabalin placebo and DS-5565 placebo BID, or pregabalin 150 mg BID.
724565|NCT02187172||
724566|NCT02187159|A total of 2280 participants who met all inclusion criteria and no exclusion criteria were enrolled from 19 Nov 2014 to 07 July 2016 at 178 sites. Of the 2280 participants enrolled, 1270 participants were randomized.|Eligible participants were randomized in a 1:1:1:1 ratio to either DS5565 15 mg QD, DS5565 15 mg BID, placebo, or pregabalin 150 mg BID.
724567|NCT02187055||Although a total of 1,152 participants were randomized, only 1,146 participants received treatment and are included in the full analysis set summarized below.
724568|NCT02187042||
724569|NCT02187029||
724570|NCT02187016||
724571|NCT02186938||
741094|NCT01116102||
724574|NCT02186834|Participants were recruited at Moffitt Cancer Center and Karmanos Cancer Center September 2014 through May 2017.|6 of the 14 participants treated at RP2D moved on from Dose 2m arm in the dose escalation portion of study.
724575|NCT02186808||
724576|NCT02186795|Inclusion criteria consisted of primary elective THA surgery with either (1) a lumbar epidural (n = 51) or (2) a lumbar plexus peripheral nerve block (n = 312) for postoperative analgaesia. Exclusion criteria were THA revision, traumatic fractures, nonelective surgery, general anaesthesia, and post-operative intensive care unit (ICU) admission.|Of the charts reviewed, 31 lumbar epidural and 153 lumbar plexus patients met inclusion criteria and were assigned a chronological number based on the date of their operation (Epidural 1-31; Lumbar plexus 1-153). These numbered lists were then randomised and data collected on the first 24 randomised patients for each block type.
724577|NCT02186665||
724578|NCT02186652|The first participant for this study began on 8-July-2014. The last participant to complete the study was on 13-September-2015.|
724579|NCT02186587||
724580|NCT02186561||
724581|NCT02186509||
724582|NCT02186301|100 subjects recruited from 74 sites, in 7 countries and randomized (1:1) to treatment with rociletinib or erlotinib.Original protocol had rociletinib starting dose of 625mg. In global Amendment 2, starting dose reduced to 500mg. Crossover to rociletinib was permitted however, only 2 patients did so. Safety data for these 2 patients are reported.|
724583|NCT02186223||
724584|NCT02186210||
724585|NCT02186171|This study was conducted at 31 centers in Europe, North America, Latin America, and Japan. Participants were enrolled from 16 June 2014 to 27 January 2015.|Participants were randomized in a 2:1 ratio to receive 210 mg romosozumab or matched placebo in a blinded fashion for the duration of the 12-month treatment period. Randomization was stratified by geographic region (Europe, North America, Latin America, and Japan).
724586|NCT02185794|Participants were enrolled at study sites in United States and Puerto Rico. The first participant was screened on 13 June 2014. The last study visit occurred on 28 September 2015.|Participants were enrolled in Cohorts 1, 2, 3, 4, 5, 6 and 10. Cohorts 7, 8, and 9 were not conducted.
724587|NCT02185729|All subjects seen at Grady Memorial Hospital Clinical Interactions Network unit of the Atlanta Clinical and Translational Science Institute. Subjects were admitted on the afternoon before the study protocol began.|An overnight fast, subjects underwent research studies in the morning with the infusion starting between 1200 and 1300 h.
724588|NCT02185534|Participants recruited at PAREXEL Early Phase Clinical Unit Berlin, Germany between August 2014 and September 2014.|84 participants recruited; 144 screened, 60 excluded (59 did not meet inclusion criteria and 1 refused participation)
724589|NCT02185521|All patients admitted to the surgical, trauma and burn ICU were evaluated for inclusion/exclusion criteria. Those who met eligibility were approached for informed consent. Legally Authorized Representatives (LAR's) were approached for patients who were too injured or ill to participate in the informed consent process.|If a Legally Authorized Representative (LAR) consented on behalf of the participant and later the participant had the capacity to self-consent and decided not to participate in the study, the participant was dropped from the study.
724590|NCT02185339|Subjects were screened and enrolled at Seoul St. Mary's Hospital from July 2014 to January 2015.|
724591|NCT02185183||
724592|NCT02185131||
724593|NCT02185105||
724594|NCT02185053||
724595|NCT02185040|The multi-center study was conducted in the United States. Forty-two participants were enrolled at 11 study sites.|In part 1 of the study, participants were randomly assigned to 1 of 4 dose cohorts; within each cohort participants were randomized in a 4:1 ratio to receive iberdomide or placebo. Participants who completed the Part 1 treatment phase were eligible to receive iberdomide for up to 2 years in the active treatment extension phase (ATEP).
724596|NCT02185014||Participants who completed Study M14-115 (NCT02185014) were eligible to enroll in this study.
724597|NCT02184988||
724598|NCT02184624|The study was conducted between 28 August 2014 and 31 July 2015 at 8 centers, 6 in the Netherlands and 2 in the United Kingdom. Only participants who were naïve to the ELLIPTA inhaler and to one of the other inhaler devices that was used in this study were included.|A total of 575 participants were enrolled in the study out of them 8 failed in screening and remaining 567 were randomized and included in intent to treat population. Participants were allocated to a particular sub-study depending on their experience of using the other inhaler (i.e., depending on which other inhaler they were naïve to using).
724599|NCT02184611|The study was conducted from 09 May 2016 to 08 November 2017 at 26 centers (21 centers in China and 5 centers in the Republic of Korea). A total of 306 participants were included in the Modified Intent-To-Treat (MITT) Population which comprised of all participants randomized to treatment who received at least one dose of study medication.|Total participants screened were 440; of which, pre-screen failures: 28, Screen failures: 94 (inclusion/exclusion criteria not met: 82, withdrew consent [WC]: 9, adverse event: 2, lost to follow up: 1) and Run in failures: 10 (continuation criteria not met: 6, WC: 4). The remaining 308 participants were randomized (but 2 were randomized in error).
724600|NCT02184572|6 subjects from 1742 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started in 1736.|US sub-cohort: Subjects recruited in US received INV_MMR (Priorix) or COM_MMR (M-M-R II/M-M-R VaxPro) co-administered with Varivax, Havrix & Prevnar 13 vaccines (Day 0). Non-US sub-cohort: Subjects recruited outside the US received INV_MMR (Priorix) or COM_MMR (M-M-R II/M-M-R VaxPro) co-administered with Varivax & Havrix vaccines (Day 0).
724601|NCT02184494||
724602|NCT02184455|This study was conducted at the Multi-disciplinary Leg Ulcer Clinic at the Queen Elizabeth II Hospital, Halifax, N.S. and Wound Care Clinic at St. Michael's Hospital, Toronto, O.N. The study was initiated on July 1st, 2016 and ended patient enrolment on March 31st, 2017.|
724603|NCT02184442|Subjects were screened and enrolled at 53 sites in the US and Canada|
724604|NCT02184208||
724605|NCT02184195|This study randomised patients at a total of 59 study centres in 12 countries: United States of America (13), Germany (8), France (7), Israel (7), Spain (7), United Kingdom (6), Italy (4), Belgium (2), Republic of Korea (2), Australia (1), Canada (1) and Netherlands (1).|Screening Part 1 was only required if a patient's gBRCAm status was unknown and Screening Part 2 was for patients with known local germline BRCA (gBRCA) test. All other screening parameters were done as per the Study Schedule.
724607|NCT02184143|838 participants assessed for eligibility. Of these 838, 513 participants were excluded. Of these 513 who were excluded, 222 did not meet inclusion criteria, 268 declined to participate, 23 were assessed too close to surgery to complete a preoperative assessment.|248 participants were consented, enrolled, and randomized.
724608|NCT02183792||
724609|NCT02183675|An open-label, randomised, six-sequence crossover design. Each participant received three treatments each for 10 days. There was no washout period between treatments.|
724610|NCT02183519|Parkinson's Disease = PD and Healthy Older Adult = HOA|10 PD participants did not respond to 200micro-molar capsaicin, and received the 500 micro-molar single dose. 3/10 PD participants did not respond to 500, and thus did not produce analyzable data. Due to a computer error, data was lost for 3 of the HOA participants. Complete data sets were analyzed for 13 PD and 25 HOA participants.
724611|NCT02182999|All patients undergoing a distal metatarsal osteotomy and lateral release with/without concomitant osteotomy of the proximal phalanx of the greater toe for idiopathic hallux valgus deformity at the Department of Orthopedic Surgery, Medical University of Innsbruck, between May 2014 and March 2017 were screened for eligibility to the study.|
724612|NCT02182973||Historical controls are not considered to be enrolled in the study. Thus, they are not counted in the enrollment numbers.
724613|NCT02182895||
724614|NCT02182843||
724615|NCT02182830|In this Phase 3b, multi-centre trial, a total of 719 patients were screened by 92 centres across the United States. The first centre was initiated on 25 Jul 2014. Of the 719 screened patients, 297 patients entered the placebo run-in phase of the trial and 166 were subsequently randomised to double-blind treatment|Empagliflozin was administered at a starting dose of 10 milligram (mg) once daily. At Week 4, patients were dose escalated to a dose of 25 mg once daily. These doses were selected based on the results from previous dose-finding studies
724616|NCT02182804|There were 631 patients with a previous history of head and neck cancer in the 10-year record. Of the 631 patients, 587 were excluded for the following reasons: patients could not be contacted (n=458), death (n=72), esophageal obstruction or stricture, previous esophageal surgery (n=34), and patients who refused to participate (n=23).|
724617|NCT02182492||Patients meeting the Chronic rhinosinusitis (CRS) diagnostic criteria outlined in the European Position Paper on Rhinosinusitis and Nasal polyps (EP3OS) definition were enrolled. Three subtypes CRS included: CRS without nasal polyps (CRSsNP); non-eosinophilic CRS with nasal polyps (Non-Eos CRSwNP); eosinophilic CRS with nasal polyps (Eos CRSwNP).
724618|NCT02182440|Patients suffering sepsis associated acute kidney injury and admitted to the ICU were recruited from December 2014 to May 2017 in 10 European countries and the USA.53 Sites recruited patients. Sepsis diagnosis was established following the Sepsis-2 criteria and AKI diagnosis was established following the AKIN criteria.|Patients should show a continuation of AKI measured by a confirmatory serum creatinine value, which did not decrease > or = 0.3 mg/dL compared to the diagnostic serum creatinine value or by a continuation of urine output of < 0.5 mg/kg/h for more than 6 hours.
724619|NCT02182115||
724620|NCT02181842|Participants took part in the study at 68 investigative sites in Japan, from 29 January 2009 to 30 June 2011.|Participants with a historical diagnosis of type 2 diabetes mellitus with presence of cerebral infarction as medical history were enrolled to receive pioglitazone 15 milligram (mg) - 30 mg tablet, orally, once daily for up to 48 weeks.
724621|NCT02181816|Participants took part in the study at 271 investigative sites in Japan, from 26 June 2014 to 31 January 2017.|Participants with a historical diagnosis of hypertension were enrolled. Participants received interventions as part of routine medical care.
724622|NCT02181803||Forty-three schizophrenia participants and 12 healthy volunteers were randomized to either MK-8189 or placebo in Part 1 Panels A & B, Part 2 Panel C, or Part 3 Panel D. MK-8189 dose and schedule were modified for participants based on tolerability.
724623|NCT02181790||
724624|NCT02181738|243 participants were treated at 34 sites in 10 countries for cohorts A, B, and C. Cohort D enrolled separately. 51 participants were treated in cohort D for a total of 294 participants treated all together.|
724625|NCT02181673||
724626|NCT02181634||
724627|NCT02181530||
724628|NCT02181517||
724629|NCT02181504||
724630|NCT02181426||
724631|NCT02181413|Participants enrolled at 167 sites in Australia, Japan, Korea, Singapore, Taiwan, Thailand, Austria, Belgium, Czech Republic, Denmark,France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, UK, Argentina, Brazil, US from 01-Jul-14 to 16-Apr-18 (data cut-off).|Participants with newly diagnosed multiple myeloma (NDMM) who had undergone induction therapy according to regional standard of care (SoC), followed by high-dose melphalan (200 mg/m^2) and Autologous Stem Cell Transplant (ASCT) were enrolled in a 3:2 ratio to receive ixazomib citrate 3 mg for 4 cycles followed by 4 mg for 22 cycles, or placebo.
724632|NCT02181400||
724633|NCT02181387|Subjects were approached after being admitted to the labor and delivery unit of our facility about participation in this clinical trial|
724634|NCT02181296|Patients undergoing shoulder arthroscopy for rotator cuff repair were recruited from the orthopedic clinic of the University of Pennsylvania.|
724635|NCT02181231||
724636|NCT02181140||
724637|NCT02181127||"31 participants were enrolled in the trial, but only 22 participants actually participated. 4 subjects were not eligible to participate. The remaining 5 subjects that did not participate were considered back up or benched subjects who were eligible and willing to participate, but were not required to meet our desired total cohort."
724638|NCT02181075||"10 patients were recruited (6 to Part I of the study and 4 to Part II of the study).
~Patients required at least one liver tumour accessible to ultrasound. Full screening criteria are available from ClinicalTrials.gov or the published protocol summary, both detailed in the References section."
724639|NCT02180893||
724640|NCT02180867||All patients began at Dose-Finding Level 1. Dose-Finding Level 0 CR, Dose-Finding Level 2 CR, and Dose-Finding Level 0 RT never enrolled because protocol-defined dose de-escalation and escalation parameters were not met. Cohorts C and D were closed to further patient accrual on October 12, 2017 due to slower than anticipated enrollment.
724641|NCT02180828||
724642|NCT02180724||
741095|NCT01116037||
741552|NCT01090921||
724643|NCT02180659|"First patient enrolled: 26 June 2014. Last patient completed: 18 May 2015
~A total of 21 Investigators participated in the study, across 21 sites in the United States."|211 patient were screened and of those,177 subjects were enrolled and randomized into the study.
724644|NCT02180646||
724645|NCT02180438||
724646|NCT02180230||
724647|NCT02180217||
724648|NCT02180165|This study was conducted in male and female Japanese participants with deep-seated fungal infection.|
724649|NCT02180100|At Clinic|
724650|NCT02180061||These results include data received prior to the safety database cutoff date of 23-Oct-2017.
724651|NCT02179918||
724652|NCT02179892|Participants were recruited from the Emory University Hospital and the Emory University Hospital Midtown between July 2014 through June 2015.|
724653|NCT02179788||
724654|NCT02179671|This study was conducted at 10 study centers in United States. The first subject was enrolled on 25 July 2014.|Due to the small numbers of patients treated in Cohorts A through C (gefitinib, AZD9291, or selumetinib + docetaxel), statistical analyses were only done and summary tables prepared for the 28 patients randomised to Cohort D (tremelimumab, either 1-cycle or 2-cycles).
724655|NCT02179424||
724656|NCT02179398||
724657|NCT02179190||
724658|NCT02179177|Patients with sickle cell disease were enrolled as an outpatient in clinic while at baseline pain from January 2015 to September 2017.|
724659|NCT02179047||
724660|NCT02178995|Participants were enrolled primarily through the Stanford Neurology and Neuropsychiatry clinics between August 2014 and July 2015.|4 participants signed their consent form, but did not complete any study visits and therefore produced no study data. Therefore, 55 participants are 'enrolled,' but only 51 actually participated in the study flow.
724661|NCT02178800||
724662|NCT02178787||Seventy four consented subjects, thirty type 2 diabetics and thirty non-diabetic controls completed the protocol. Screened participants that did not start the study: eleven were found ineligible after signing informed consent, two withdrew consent, one lost to follow up.
724663|NCT02178722|Participants took part in the study at 21 investigative sites in the United States from 17July 2014 to 26 Nov 2018 (until data cut-off date).|A total of 444 participants were enrolled in the study. Study enrollment was permanently discontinued on 17 May 2018 as a strategic decision. At the time of data cut-off, 26 Nov 2018, 82 participants were ongoing.
724664|NCT02178709||
724665|NCT02178696|4 consented volunteers dropped because of exclusion criteria|Of 44 participants consented, 4 were not assigned to participate due to screen failures.
724666|NCT02178592|This study was conducted in 7 countries across 25 centers; Argentina (2), Brazil (4), Mexico (3), Peru (4), Russia (2), South Africa (8) and Thailand (2) from 23-January-2015 and is still ongoing. The results presented are based on the Week 48 Primary Analysis (Week 48 data cutoff date 08-March-2018). A total of 113 participants were enrolled.|A total of 263 participants were screened of which 150 were screen failures the reasons of which were did not meet inclusion/exclusion criteria (139), , lost to follow-up (3), investigator discretion (7), withdrawal of consent (4).
724667|NCT02178553||
724668|NCT02178540||
724669|NCT02178475|The study was conducted at 66 centers in Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Poland, and Romania. The first participant enrolled on 18 July 2014 and the last participant enrolled on 28 April 2016.|Participants were enrolled at sites where they were receiving treatment as part of their routine standard of care. No specific interventional tests, investigations, procedures or changes to routine practice were conducted as part of this study.
724670|NCT02178358||In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
724671|NCT02178241|Twenty-six patients were enrolled, but 2 did not receive treatment due to medication compliance related to diabetes and another deemed ineligible after registration but prior to treatment start.|
724672|NCT02178059|This was a single centre study conducted in the UK.|Healthy subjects were assessed for eligibility at a screening visit (Visit 1) within 28 days of administration of the first dose of terbutaline via Bricanyl Turbuhaler M2 or Bricanyl Turbuhaler M3 (Visit 2). Subjects were randomly assigned to 1 of 2 treatment sequences: M3 then M2 or M2 then M3
724673|NCT02177942|Participants were recruited at one center in India.|A total of 656 participants were screened out of which 528 were randomized to study treatments. 363 participants completed the study. Of the 165 randomized participants not completing the study, 152 withdrew consent, 10 participants violated the protocol, 2 participants were lost to follow up and 1 withdrew due to adverse event.
724674|NCT02177812|A total of 41 participants with relapsed/refractory acute myeloid leukemia (AML) were enrolled in Part 1 at different centers in Australia, Canada and United States. This study was planned to be conducted in 2 parts :Part 1 (dose escalation) and Part 2 (Expansion Cohort).|This study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study and therefore, Part 2 was not conducted. There were no active participants on study when the study was terminated.
724675|NCT02177786|Participants were enrolled at study sites in United States and Canada. The first participant was screened on 30 June 2014. The last study visit occurred on 22 August 2016.|893 participants were screened.
724676|NCT02177773||
724677|NCT02177266|Subjects were enrolled at Mayo Clinic in Rochester, Minnesota.|
724678|NCT02177201||
724679|NCT02177136||A total of 77 patient were randomly allocated to treatment with placebo, 1.5 mg OCA titrated to 3 mg OCA or 5 mg OCA titrated to 10 mg OCA; however, 1 subject did not receive treatment.
724680|NCT02177032||All enrolled subjects were included in the trial.
724681|NCT02176928||
724682|NCT02176837||
724683|NCT02176655||
724764|NCT02169674|Screening for eligibility will be part of volunteer identification, with confirmation of eligibility to follow at the first in-person visit. A component of volunteer screening will be initiating a review of individual HBV immunization records.|Initially, 359 volunteers who met inclusion criteria where recruited, of whom 6 were deemed ineligible due to late disclosure of neonatal HBV vaccination (n=3), ineligible medical condition (n=2) or additional doses of HBV vaccine (n=1). Three early consent withdrawals resulted in 350 participants who underwent baseline testing.
724684|NCT02176642|Potential participants were identified, recruited, and enrolled at the time of their outpatient clinic visits with the Duke Urogynecology clinic. All women who were considering therapy with posterior tibial nerve stimulation were approached for participation in the study.|A total of 104 patients were assessed for eligibility. Forty-nine patients declined or were deemed ineligible. Fifty-five patients consented to participate but 20 dropped out before randomization. Therefore, a total of 35 patients were randomized as noted in the boxes below (18 in the active medication group, 17 in the placebo group).
724685|NCT02176525|acronyms used in pre-assignment details: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP)|Each patient participating in the trial (or the patient's legally accepted representative) provided written informed consent according to ICH GCP and the regulatory and legal requirements of the participating country. All subjects were informed that they were free to withdraw their consent at any time during the study without penalty or prejudice.
724686|NCT02176486|Participants took part in the study at 8 investigative sites in the United States, Spain and Russia from 09 June 2014 to 19 January 2018.|Participants with a historical diagnosis of lupus nephritis (LN) were enrolled to receive ixazomib as multiple rising doses (MRD) of 0.5 milligram (mg) in Cohort A and 2.0 mg in Cohort B. This study was terminated early after the completion of Cohorts A and B due to lack of sufficient enrollment to complete the study.
724687|NCT02176421||
724688|NCT02176408||Seven participants were enrolled in the study but not randomized to one of the two intervention arms. Four participants were excluded after the screening visit due to not meeting study inclusion criteria. Three participants completed screening but discontinued the study prior to attending the baseline visit (during which randomization occurs).
724689|NCT02176356||
724690|NCT02176343|Subjects were recruited from 4 study centers located in Australia.|Of the 37 enrolled, 6 subjects were exited as screen failures and were ineligible to participate in the study. This reporting group includes all subjects who provided informed consent and were determined to be eligible based upon the inclusion and exclusion criteria (As Treated) (31).
724691|NCT02176291||
724692|NCT02176226||
724693|NCT02176083||
724694|NCT02176031|This study enrolled subjects with newly diagnosed acute gastrointestinal (GI) graft-versus-host-disease (GVHD) from 2 academic medical centers in the United States. The last patient completed the study in February 2019.|
724695|NCT02176018||A total of 90 participants were screened, 14 failed to meet the inclusion criteria and were screen failed. 76 participants were enrolled into a 28-day run-in period. 31 were excluded from the study prior to being assigned to a treatment arm, due to failure to meet inclusion criteria. A total of 45 participants were randomized.
724696|NCT02176005|Healthy volunteers were recruited from March 20th, 2014 (date of first enrolment) and October 17th, 2014 (date of last completed)|
724697|NCT02175979||
724698|NCT02175966||35 participants enrolled in the study, 28 were randomized. Of the 7 not randomized, 1 participant withdrew consent and 6 no longer met study criteria
724699|NCT02175771|Of the 1087 patients screened, 758 patients at 103 investigational centers in the US met entry criteria. 331 patients were not enrolled: 267 due to inclusion/exclusion criteria, 21 withdrew consent, 9 were lost to follow up, 4 had an adverse event, and 30 patients had reason of 'other' or missing.|Participants in each strength of the ICS monotherapy cohort were randomly assigned in a 3:1 distribution to either the Fp MDPI or FLOVENT HFA treatment arm. Participants in each strength of the ICS/LABA combination cohort were randomly assigned in a 3:1 distribution to either the FS MDPI or ADVAIR DISKUS treatment arm.
724700|NCT02175758|Participants were enrolled at study sites in Australia, Europe, Russia, New Zealand, and the United States. The first participant was screened on 07 July 2014. The last study visit occurred on 13 September 2018.|135 participants were screened.
724701|NCT02175745||
724702|NCT02175628||
724703|NCT02175472||
724704|NCT02175368||
724705|NCT02175277|This study was conducted at 5 centers in Belgium from 12 June 2014 (first participant enrolled) to 20 March 2017 (last participant completed study).|This study enrolled participants who completed the active treatment period of the phase 3 Study 20090160 (NCT01362140).
724706|NCT02175225||
724707|NCT02175212|Between Nov 7, 2005, and Dec 20, 2010, 362 were registered. Of these, seven did not meet the inclusion criteria. The final trial population thus consisted of 355 men, of whom 178 were randomly assigned to the short-term androgen deprivation group and 177 to the long-term androgen deprivation group.|
724708|NCT02175199|Subjects were recruited from 10 Study Centers located in the US.|Of the 151 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (150).
724709|NCT02175121|Eligibility included male participants or female participants of non-childbearing potential, 18 to 70 years of age (inclusive) who were willing and able to wash off all diabetes medications.|
724710|NCT02174913||
724711|NCT02174861|Participants were enrolled at 64 centers across North America and Europe from 30 June 2014 to 4 March 2016. Participants who completed the 12-week double-blind treatment of the parent Study 20120295 (NCT02066415) and met all Study 20130255 eligibility criteria were eligible for enrollment into this study.|Participants at sites in the United States, Sweden, and Germany had the option of enrolling in the Clinical Home Use (CHU) Substudy to assess their ability to self-administer 140 mg erenumab for in-home use. Participants in the substudy were randomized 1:1 to self-administer erenumab using either a prefilled syringe or autoinjector/pen.
724712|NCT02174848||
724713|NCT02174731|This study was conducted at 197 centers in 18 countries worldwide across the United States (US), Canada, Latin America, Australia, Asia and Europe between 01 July 2014 and 26 September 2018. Participants with chronic kidney disease (CKD) who were on dialysis were recruited in this study.|Study had a screening period (up to 6 weeks), treatment period (up to 4 years) and follow-up period (4 weeks after treatment period for those who completed treatment). 2133 participants were randomized, of which 2106 were included in the analysis and 27 were excluded. Only participants included in the analysis are presented in the participant flow.
724765|NCT02169505|Participants who have had an Allogeneic and Haploidentical Stem Cell Transplantation in High Risk CD30+ Lymphoma (Hodgkin Lymphoma and ALCL)|
724766|NCT02169479||
724767|NCT02169466||
724768|NCT02169453||
724714|NCT02174627|This study was conducted at 385 centers in 25 countries worldwide across the United States, Canada, Latin America, Asia and Europe between 26 June 2014 and 04 October 2018. Participants with chronic kidney disease who were not on dialysis were recruited in this study.|Study had a screening period (up to 6 weeks), treatment period (up to 4 years) and follow-up period (4 weeks after treatment period for those who completed treatment). 2781 participants were randomized, of which 2761 were included in the analysis and 20 were excluded. Only participants included in the analysis are presented in the participant flow.
724715|NCT02174562||
724716|NCT02174523|Total 27 subjects were screened at the clinical site after obtaining informed consent. A total 14 subjects were enrolled into the study and were randomized to lurasidone group (10) and placebo group (4). The data of informed consent from the first subject was 8th April 2014（and that from the last subject was 15th April 2014）.|
724717|NCT02174510|Total 72 subjects were screened at the clinical site after obtaining informed consent. The data of informed consent from the first subject was march 2014. A total of 37 subjects were enrolled into the study and were randomized to three test drug groups (8 to 20mg group, 8 to 40mg group, 12 to 80mg group), and 9 subjects received placebo.|
724718|NCT02174432||
724719|NCT02174419||
724720|NCT02174276|Participants were enrolled at study sites in North America, Europe, New Zealand, and South Korea. The first participant was screened on 24 July 2014. The last study visit occurred on 30 May 2018.|254 participants were screened.
724721|NCT02174198||
724722|NCT02173769|An open, prospective non-interventional study in patients with moderate to severe chronic obstructive pulmonary disease (COPD).|
724723|NCT02173704|Subjects were recruited from 2 sites in Taiwan|All subjects were enrolled
724724|NCT02173548||
724725|NCT02173535||A total of 257 subjects were enrolled into this study. Of the enrolled subjects, 240 subjects were dispensed at least 1 study lenses, while 17 subjects failed to meet the eligibility criteria. No subjects were discontinued during the course of this study.
724726|NCT02173522||
724727|NCT02173392||
724728|NCT02173379|A total of 2604 subjects were randomized at 147 sites between August 15, 2014 and March 31, 2017. The last 1-year follow-up visit occurred on March 31, 2018. The database was then cleaned and locked, and data extraction for the 2-year analysis occurred on June 04, 2019.|The last 2-year follow-up visit occurred on 16 April, 2019.
724729|NCT02173158||
724730|NCT02173054|The recruitment period: between June 2014 and December 2014 Location: Department of Dermatology, Siriraj Hospital, Mahidol University, Thailand|
724731|NCT02172820||
724732|NCT02172755||
724733|NCT02172742||
724734|NCT02172664||
724735|NCT02172625|40 subjects were recruited. 2 subjects were excluded. 1 not meeting inclusion criteria, and 1 declined to participate. Thus, 38 subjects were randomized into either the Protandim Group (n = 19) or Placebo Group (n = 19)|
724736|NCT02172040||Participants underwent assessments to determine eligibility at the Initial Screening Visit (Day -7 to -2; 458 participants), Final Screening Visit (Day -1; 228 participants), and the morning prior to randomization (Study Day 0; 227 participants). A total of 306 participants were screen failures and the remaining 152 were randomized.
724737|NCT02171819||
724738|NCT02171611||
724739|NCT02171260|Participants took part in the study at 18 investigative sites in the United States from 31 July 2014 to 28 January 2016.|In Part A1, a total of 23 participants of greater than or equal to (>=) 12 months were enrolled, of which 22 were treated in the study. In Part A2, the study was open for the enrolment of infant participants of less than 12 months of age, however no participants were enrolled into this part.
724740|NCT02171247|35 subjects signed consent. 2 subjects were not assigned to a arm and were withdrawn from study due to impaired renal function. 33 subjects completed the study.|
724741|NCT02171234||
724742|NCT02171195||
724743|NCT02171130|Participants and their principal caregiver(s) were trained in the use of nasal glucagon.|
724744|NCT02170870|Subjects were recruited from Mayo Clinic in Rochester, Minnesota.|
724745|NCT02170779||
724746|NCT02170727||Total of 169 subjects were treated; 138 treatment-naive and 31 treatment-experienced; 3 participants did not complete the treatment period (1 was lost to follow-up and 2 had withdrawn)
724747|NCT02170688||
724748|NCT02170662||
724749|NCT02170649||
724750|NCT02170532||
724751|NCT02170519||
724752|NCT02170389||
724753|NCT02170376||
724754|NCT02170363|50 patients were recruited at 10 cardiac transplant centers and implanted between June 25, 2014, and November 27, 2014|The data presented in this record includes all 50 patients followed through to the 6-month primary endpoint.
724755|NCT02170298||
724756|NCT02170220|Participants took part in the study at 1 investigative site in the United States from 09 July 2014 (first participant signed the informed consent form) to 01 December 2014.|Participants with normal hepatic function and participants with severe hepatic impairment received a single dose of 5 mg vortioxetine.
724757|NCT02170207|Participants took part in the study at 14 investigative site in Japan from 29 January 2007 to 31 March 2010.|Participants with a historical diagnosis of acute stress ulcer or acute gastric mucosal lesion accompanied with bleeding, for whom oral administration of drug was not feasible were observed in a single treatment group to receive lansoprazole 30 milligrams (mg).
724758|NCT02170077||
724759|NCT02170064||
724760|NCT02170051||2 participants received the wrong diagnosis, and were withdrawn from the study; 7 participants had a CAINS score of ≤19, and were excluded from the study
724761|NCT02170025|The study was conducted at multiple centers in 7 countries worldwide between 30-Sep-2014 (first subject first visit) and 31-Jan-2017 (last subject last visit).|Of 31 participants who were screened, 10 failed screening, 21 were randomized.
724762|NCT02169895||
724763|NCT02169869||
724769|NCT02169440||
724770|NCT02169427||
724771|NCT02169414||
724772|NCT02169336||
724773|NCT02169284||50 were consented, 13 participants ineligible
724774|NCT02169271|A total of 619 ld-CT scans, belonging to the lung screening programs, showed potentially eligible nodules. A total of 109 subjects signed a written informed consent and underwent baseline visit while 98 have been randomized.|After enrollment, 11 participants were not randomized (baseline screening failures)
724775|NCT02169219|"New diagnosis or flare of previously diagnosed disease in patients followed in the Massachusetts General Hospital (MGH) Rheumatology or Nephrology Units.
~New diagnosis or flare of previously diagnosed disease in patients hospitalized at MGH."|
724776|NCT02169115||
724777|NCT02168946|The first patient enrolled November 2014 and last patient in June 2017. The patients were enrolled at 27 study sites in 8 countries. 77 patients (28 with bacteremia, 34 with cUTI, 8 with HABP/VABP and 7 with cIAI) were enrolled and 47 had confirmed Carbapenem-Resistant Enterobacteriaceae and therefore were included in the mCRE population.|Randomization was stratified by presenting indication (cUTI or AP, cIAI, HABP, VABP, or bacteremia) and by region (North America, Europe, Asia Pacific, and Rest of World).
724778|NCT02168933||
724779|NCT02168855||While 505 participants were enrolled in and began the study, only 369 of these were ultimately randomized to the active nicotine gum or inactive (placebo) gum arms. Those who were not randomized due to either participant-initiated drop out (n=36), research-team-initiated withdrawal due to noncompliance (n=83), or loss to followup (n=17).
724780|NCT02168842|Patients were recruited from 57 Parkinson Study Group sites in North America from November 2014 through November 2015.|413 patients were assessed for eligibility. 12 patients declined to participate and 65 patients were excluded (9 exclusionary medications, 2 other medical psychiatric or surgical, 5 disease too advanced, 6 diagnosis uncertain, 23 didn't meet other inclusion criteria, 20 other). 336 patients were enrolled and underwent randomization
724781|NCT02168816|Participants were recruited from March 2014 through February 2017 (36 months) from a tertiary care practice|Prior to randomization, 16 participants were excluded because they tested positive for organisms that were resistant to oral antibiotic therapy. Additionally, one participant withdrew prior to randomization and one participant was excluded prior to randomization due to a definitive amputation.
724782|NCT02168803||Participants were enrolled into 3 parallel cohorts. Each participant received a single dose, after which PK was evaluated for 7 days, and then continued receiving once daily doses for 12, 24, or 52 weeks. After the last once-daily dose, PK was again evaluated in each participant until the concentration of evacetrapib was too low to be measurable.
724783|NCT02168777|Study was planned to have two parts, Phase 1b part and Phase 2 part. For the Phase 1b part, altogether 34 participants were screened, and 14 out of them were screening failures.|The remaining 20 participants were assigned to and started treatment in one of three dose escalation cohorts. The Phase 2 part was not conducted.
724784|NCT02168660||
724785|NCT02168491|11 patients were screened|2 patients declined to participate because of time restraints, thus study medication was administered in 9 patients
724786|NCT02168478|All subjects were recruited at single center- CPTC (Consumer Product Testing Corporation) located in Fairfield NJ.|There was no wash-out or run-in period
724787|NCT02168439||
724788|NCT02168387|All mechanically ventilated patients 0-17 years of age admitted to the Pediatric Intensive Care Unit (PICU) and Pediatric Cardiac Intensive Care Unit (PCICU) from January 2011 to March 2012 with radiographic evidence of atelectasis for which mucolytics or CHFO therapy were being initiated by the patient care team were screened for enrollment.|
724789|NCT02168361||
724790|NCT02168309||
724791|NCT02168270||
724792|NCT02168153|Participants were primarily referred to the project manager from physical therapists and other healthcare providers. The remainder of the participants were recruited from informational presentations by the site project manager, informational emails, and the SOF newsletter.|
724793|NCT02168101||
724794|NCT02168062||This study included a small, non-randomized pilot cohort of 8 patients receiving concurrent chemohormonal therapy who were enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population but were not included in the final group comparisons.
724795|NCT02167893|Participants took part in the study at 758 investigative site in Japan from 13-Oct-2005 to 31-Dec-10.|Participants with a historical diagnosis of prostate cancer were treated with leuprorelin acetate 11.25 milligrams (mg) in daily medical practice along with adjuvant therapy were observed.
724796|NCT02167867||
724797|NCT02167815||
724798|NCT02167594|Subjects recruited between Aug 2014 and Jul 2016.|
724799|NCT02167451||
724800|NCT02167256||
724801|NCT02167217||
724802|NCT02167204||
724803|NCT02167139||
724804|NCT02167074||3 patients were included but met exclusion criteria 4 patients were lost to follow-up
724805|NCT02167035||
724806|NCT02166697|Participants took part in the study at 1,126 investigative sites in Japan from 7 June 2006 to 30 November 2010.|Participants with a historical diagnosis of hypertension with metabolic syndrome-related risk factors were observed in a single treatment group to receive candesartan cilexetil 4 milligrams (mg).
724807|NCT02166606|Enrollment in the study began on 02 April 2014. The enrollment completion for the GENTLE study was communicated to the participating sites on 26 February 2016. However, additional subjects were enrolled after this date and the last subject signed consent on 08 March 2016. The last subject last visit was on 07 June 2016.|1184 subjects signed the informed consent (IC). 4 subjects signed the IC only after the end of enrollment. 1180 subjects signed IC before the end of enrollment and are considered 'actively enrolled'. 1174 subjects met all eligibility criteria and were thus considered 'consent eligible' and were considered for the baseline.
724808|NCT02166476||
724809|NCT02166346||
724810|NCT02166047|Participants were enrolled at study sites in the United States, Canada, Italy, South Korea, The Netherlands, and New Zealand. The first participant was screened on 30 June 2014. The last study visit occurred on 20 October 2016.|"All participants continued their approved HBV oral antiviral therapy (tenofovir disoproxil fumarate (TDF), entecavir (ETV), adefovir, lamivudine, or telbivudine, either as single agents or in combination) throughout the study.
~200 participants were screened."
724811|NCT02165904||
724812|NCT02165839||
734812|NCT01478347|Subjects were recruited from a single center.|All enrolled subjects participated in the study.
724813|NCT02165826|Participants took part in the study at 161 investigative sites in Bulgaria, Germany, Greece, Hungary, Korea, Philippines, Poland, Romania, Russia, Slovakia, South Africa, Spain, Thailand, Ukraine and the United Kingdom from 30 April 2014 to 21 October 2015.|Participants with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) were enrolled equally in 1 of 3 treatment groups in the Main Treatment Period: roflumilast 250 μg then 500 μg once daily (OD), 500 μg every other day (EOD) then 500 μg OD and 500 μg OD. Participants who discontinued received 250 μg in the Down-Titration Period.
724814|NCT02165761||
724815|NCT02165735||
724816|NCT02165722|Cluster randomized trial where units reflect clinical practices enrolled. Numbers of participants who started and ended study reflect the longitudinal analytic data set of patients who had a visit during both the baseline and intervention periods.|
724817|NCT02165605||
724818|NCT02165462|Patients with haemophilia|
724819|NCT02165397|This study was conducted in 48 sites (10 in the United States, 30 in Europe, 4 in Canada and 4 in Australia).|Participants were randomized in a 1:1 ratio to receive ibrutinib + rituximab (Ibr+R) or placebo + rituximab (Pbo+R). Separately, participants refractory to treatment with rituximab were enrolled in an open-label ibrutinib monotherapy substudy to further investigate the safety and efficacy of ibrutinib.
724820|NCT02165384||
724821|NCT02165202||Participants will be randomized to either the active product regimen or the placebo arm at enrollment. Participants randomized to active and placebo product will first be prescribed oral TMC278 (rilpivirine) 25 mg capsule and oral placebo capsule, once daily for four weeks as an oral run-in and then will receive IM injections at week 4.
724822|NCT02165124||
724823|NCT02165111||
724824|NCT02165072||
724825|NCT02164981||Per the Sequential Parallel Comparison Design, the 18 subjects in the SNP-SNP group were excluded from Phase 2 analyses. There were no Phase 1 placebo responders, so no exclusions were made based on this SPCD criterion. Ph 1 (N=52): all groups; Ph 2 (N=34): (Placebo)-Placebo (N=18), (SNP)-Placebo (N=16). All subjects were followed for 28 days.
724826|NCT02164929||Of the 17 patients that consented, one patient withdrew before randomization
724827|NCT02164916||
724828|NCT02164864|Patients aged ≥80 years in the United States of America (USA) were assigned to 110 milligram (mg) Dual antithrombotic therapy with dabigatran etexilate (DE-DAT), 150 mg DE-DAT, or warfarin. All other patients including aged ≥80 years (for Japan ≥70 years) outside of the USA were assigned to 110 mg DE-DAT or warfarin|All patients (Pts) were screened for eligibility to participate in trial. Pts attended sites to ensure that they met all implemented inclusion/exclusion criteria. Pts were not to be randomised to trial drug if any of specific entry criteria was violated. In this study, 2725 Pts were entered & randomised. 2678 Pts were treated.
724829|NCT02164721||
724830|NCT02164539|Participants (par.) with sufficient signs and symptoms to diagnose as having chronic obstructive pulmonary disease (COPD) and evidence of an asthmatic component as demonstrated by spirometry, reversibility and current therapy at the point of screening were eligible for participation in the study.|Participants on inhaled corticosteroid therapy over the previous 12 weeks, including a stable dose during the 4 weeks prior to Visit 0, entered the 4-week run-in period on open-label fluticasone propionate 250 microgram (µg) and salmeterol 50 µg combination. Eligible par. were stratified by smoking status, age and randomized to Treatment Phase A.
724831|NCT02164513|Participants with chronic obstructive pulmonary disease (COPD), were randomized to the study. Study was conducted from 30 June 2014 to 17 July 2017, at total of 971 sites in 37 countries.|
724832|NCT02164396||A total of 30 subjects were enrolled in this study. Of the enrolled subjects all 30 were dispensed study lenses and completed all study visits.
724833|NCT02164383||
724834|NCT02164318||
724835|NCT02164240||
724836|NCT02163993|Treatment period (0 to 12 weeks), Post-treatment period (12 to 24 weeks)|
724837|NCT02163967||
724838|NCT02163915|Participants took part in the study at 1 investigative site in the United States from 23 May 2014 to 03 November 2014.|Participants with a historical diagnosis of attention-deficit/hyperactivity disorder (ADHD) were enrolled in one of the five cohorts to receive TAK-137 (0.5 milligram [mg], 2 mg, 5 mg, 10 mg, or matching placebo) once daily for up to 7 days.
724839|NCT02163902|The objective of this non-treatment, double-blind, placebo-controlled follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study.|Participants who previously received deoxycholic acid or placebo injections in studies ATX-101-11-22 and ATX-101-11-23 were enrolled in this non-treatment, double-blind, placebo-controlled follow-up study to further evaluate safety and efficacy.
724840|NCT02163837||all participants of this single arm study were actively enrolled
724841|NCT02163824||
724842|NCT02163811|Of 182 enrolled 147 were randomized|9 Deaths, 26 withdrawal
724843|NCT02163733|First subject enrolled: 14 November 2014; Last Subject Last Visit for Part A: 23 March 2015 and Part B: 22 March 2016. The study was performed at 12 sites across Asia and Western Europe. Part A determined effect of food on PK of AZD9291; Part B allowed subjects further access to AZD9291 and provided additional safety data.|43 subjects were enrolled (signed informed consent). Subjects were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 5 subjects were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 38 subjects started Period 1 and received treatment.
724844|NCT02163577||
724845|NCT02163538||
724846|NCT02163499|Participants took part in the study at 56 sites in the Unites States, Australia, South Africa, Germany, the United Kingdom and the Netherlands from 23 June 2014 to 04 November 2016|
724847|NCT02163486||
724848|NCT02163447||
724849|NCT02163421|Participants took part in the study at 1 investigative site in the United Kingdom from 09 June 2014 to 16 January 2015.|Healthy participants of age group 18 years to 60 years were enrolled in 1 of the 4 treatment groups: Vedolizumab intravenous 300 milligram (mg); Vedolizumab subcutaneous 54 mg; Vedolizumab SC 108 mg and Vedolizumab SC 160 mg.
724850|NCT02163395||
724851|NCT02163187||
735896|NCT01411137|Date first subject enrolled: August 19, 2011 Date last subject completed: March 20, 2013|
724852|NCT02163057|Participants with a diagnosis of HPV associated head and neck squamous cell carcinoma were enrolled in the study between 13th August 2014 to 23rd January 2017.|
724853|NCT02162992||
724854|NCT02162979||Documentation regarding the randomization of the two enrolled participants cannot be located. Therefore no meaningful data are available for entry in the data tables.
724855|NCT02162862|Recruitment took place at the Digestive Disorders Clinic at Presbyterian Hospital in Pittsburgh, PA. Recruitment began 11/13/13 and ended 2/18/16.|
724856|NCT02162771||A total of 184 participants were screened for the study. Of those, 44 participants failed screening and 140 participants were enrolled in the study.
724857|NCT02162758|Participants took part in the study at 2 investigative sites in the United States from 16 July 2014 to 09 May 2016.|Participants with a diagnosis of Barrett's esophagus (BE) who had achieved complete eradication of intestinal metaplasia (CEIM) with radiofrequency ablation (RFA) were enrolled in 1 of the 2 treatment groups: Dexlansoprazole 60 milligram (mg), once-daily (QD); Dexlansoprazole 60 mg, twice daily (BID).
724858|NCT02162680|99 subjects consented in the study. 1 subject withdrawn from study by PI, therefore 98 subjects completed study.|
724859|NCT02162667||
724860|NCT02162576|The study recruited residents from community events, clinics and retail pharmacies using a convenience sampling strategy. Participants were eligible if they reported a physician diagnosis of asthma and a current prescription for SABA medication. Recruitment occurred between 6/2012 and 1/2013, with the last subject exiting the program in 1/2014.|A run-in period of 30 days was designed to limit enrollment to those participants who could comply with the study requirements. In order to be included in the study, the participant would have to 1) create an account, 2) activate their sensor, and 3) remain active (defined by sensor syncing) for the first 30 day run-in period.
724861|NCT02162446|This open-label, micro-dosing study with 2 sequentially ascending single peptide doses was conducted in a single study center in Switzerland between 23 June 2014 and 14 January 2015.|A total of 12 participants with histologically confirmed gastro-entero-pancreatic neuroendocrine tumors (GEP NET) and a previously performed somatostatin receptor scan were treated in this study. Each participant underwent a screening visit within 28 days prior to receiving the study's investigational product (IP).
724862|NCT02162433||
724863|NCT02161757|"First patient enrolled: 13 Jun 2014; Week 52 cut-off: 28 Feb 2017; Last Patient Last Visit Week 72: 18 Jul 2017. Study performed at 254 sites in 14 countries.
~Patients were maintained on currently prescribed inhaled corticosteroid long-acting β2-agonist therapy + any additional maintenance asthma controller medications throughout the study period."|2248 patients signed informed consent, 1669 entered screening/run-in period, 1207 patients were randomised to receive treatment with tralokinumab 300 milligrams (mg), or placebo, every 2 weeks (Q2W) or every 4 weeks (Q4W). Of the 1207 patients randomised, 1202 received investigational product (IP).
724864|NCT02161731||
724865|NCT02161705||
724866|NCT02161575|Patients were recruited from 22 sites located in the United Kingdom and 6 sites located in Germany. A total of 103 patients received at least 1 dose of study drug.|Of the 103 patients who received at least 1 dose of study drug, 3 patients did not have any post-baseline safety or CSRT assessments and were therefore excluded from the SAF and FAS, in accordance with the analysis set definitions. Therefore, 100 patients were included in the SAF and FAS.
724867|NCT02161562||Patients were randomly assigned in a 4:3 ratio to Group A or Group B.
724868|NCT02161549|"The recruitment was done in two phases:
~Phase 1- under protocol Rev 1.0 used MotusGi CleanUp System Rev 1.0 , study period Aug- Jan 2012. 40 subjects enrolled.
~Phase 2- under protocol Rev 2.0 used MotusGi CleanUp System Rev 1.5 , study period Jul-Oct 2013.31 subjects enrolled."|
724869|NCT02161536|"The study was conducted in 3 phases:
~Phase 1 - enrolled 6 subjects using Rev 2.0 of the device Phase 2 - enrolled 21 subjects using Rev 2.5 of the device Phase 3 - enrolled 20 subjects using Rev 3.0 of the device"|"Patients had to follow a specific bowel preparation in order to mimic poor bowel preparation:
~Arm 1: start clear liquid diet 24 hours prior to the procedure Arm 2: start clear liquid diet 24 hours prior to the procedure Arm 3: start clear liquid diet 18 hours prior to the procedure along with 4 tables of 5 mg Bisacodyl in split dose"
724870|NCT02161484||
724871|NCT02161458||
724872|NCT02161406||
724873|NCT02161185||
724874|NCT02161146||
724875|NCT02161133||
724876|NCT02161016||
724877|NCT02160990||
724878|NCT02160977|From October of 2011 to June of 2012, patients who suffered from severely osteoarthritis were recruited in this study.All the patients were hospitalized patients at Peking University Third Hospital.Patients were randomly divided into two groups by digital random method.|Patients refused to receive MIS-QS TKA or MIS TKA.
724879|NCT02160899|A total of 51 participants were enrolled in Cohort A and 13 participants were enrolled in Cohort B.|A total of 86 participants were screened for the study and 64 participants were randomized into Cohort A and Cohort B and received study treatment. Two participants in Cohort B did not complete the study treatment but completed the post-treatment follow-up.
724880|NCT02160873|12 subjects were recruited from the Tallahassee running community.|Subjects were randomized to receive either chocolate milk first or placebo first. In between exercise trials, there was a 7-day washout period.
724881|NCT02160847||
724882|NCT02160808||
724883|NCT02160626||
724884|NCT02160535||
724885|NCT02160314||224 subjects signed an informed consent, 79 did not meet inclusion/exclusion criteria and were screen failed.
724886|NCT02160288||
724887|NCT02160145|First subject first visit: 21 May 2014; Last subject last visit: 18 April 2017. Subjects were recruited from 213 sites in 21 countries. Of 2292 subjects screened, 1519 entered the 6-week run-in period; 23 were placebo run-in failures and 126 were tolvaptan titration/run-in failures.|Subjects with Stage 2 - 4 chronic kidney disease (CKD) due to Autosomal Dominant Polycystic Kidney Disease (ADPKD) were stratified by baseline estimated glomerular filtration rate (eGFR) (≤ 45 or > 45 milliliters/minute/ 1.73 square metres [mL/min/1.73 m^2]), by age (≤ 55 or > 55 years), and total kidney volume (≤ 2000 mL, > 2000 mL, or unknown).
724888|NCT02160041||
725029|NCT02151331||A total of 383 participants were consented and enrolled to participate. Of those 383 participants, only 169 were randomized participants from a non-responsive site.
724889|NCT02160002||1565 infants were screened for eligibility. 1199 infants were excluded. 680 were excluded due to not meeting all eligibility conditions, 510 did not get consent for randomization, and 9 were consented but not randomized due to parent (1 infant) or doctor withdrawal (1 infant), becoming medically unstable (3 infants) or other reasons (4 infants).
724890|NCT02159976||
724891|NCT02159950||
724892|NCT02159898||
724893|NCT02159859||
724894|NCT02159807|Enrollment period from April 2015 and completed Dec 2017|
724895|NCT02159768|Recruitment from 16 July 2014 to 27 July 2015, in hospital ward, before surgery and anesthesia.|
724896|NCT02159729|The objective of this non-treatment, placebo-controlled, 5-year follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study.|Participants who previously received deoxycholic acid or placebo injections in studies ATX-101-06-03, ATX-101-07-07, & ATX-101-09-15 were enrolled in this non-treatment follow-up study to further evaluate safety and efficacy.
724897|NCT02159703||
724898|NCT02159547||
724899|NCT02159521||
724900|NCT02159482||
724901|NCT02159469|Approximately 150 patients were enrolled in this study. 128 patients completed through at least Week 26, 98 patients completed through Week 52, and 97 patients completed the full study (through the Follow-up Visit).|The study was designed to ensure a minimum of 100 patients completed a collection of 26 weeks of safety data, and a minimum of 50 patients completed a collection of 52 weeks of safety data. Minimum enrollment goals were exceeded.
724902|NCT02159365|84 participants were enrolled. 70 participants were randomized and treated. Reasons for non-randomization/non-treatment were 10 no longer met study criteria, 1 withdrew consent, and 3 due to other reasons.|
724903|NCT02159352|Participants were enrolled at 1 site in the United States of America.|Of 49 participants enrolled, 28 were randomized to receive treatment. Of the 21 who were not randomized, 16 no longer met study criteria and 5 discontinued due to other reasons.
724904|NCT02159183||
724905|NCT02159118||
724906|NCT02159079||
724907|NCT02159053|The study was conducted at 85 centers in 19 countries.|A total of 424 participants were screened, out of which 350 participants completed the screening phase and were randomized to three treatment groups in 1:1:1 ratio.
724908|NCT02159040|Recruitment ended with patient death.Only one patient in trial. No analysis will ever be done.|
724909|NCT02158975||
724910|NCT02158949||
724911|NCT02158936||A total of 356 patients were enrolled in the study and 2 patients did not receive treatment.
724912|NCT02158884|Subjects were screened and enrolled at 3 military treatment sites in the US.|Study participants included service members who had functional deficits that interfered with daily activities at least 1 year after a traumatic unilateral lower-extremity injury at or below the knee. This is not a randomized study, all consented participants were provided with an IDEO brace and the Return to Run Physical Therapy program.
724913|NCT02158806|Participants were screened and recruited from five study sites in New Zealand|Enrolled participants were required to have their family physician confirm they could safely participate in the trial ie had no conditions that required treatment with aspirin and no conditions that contraindicated use of aspirin.
724914|NCT02158728||
724915|NCT02158663|Veterans suffering from PTSD with and without depressive symptoms will be recruited from the community as well as from the mental health clinics at the James A. Haley VAH.|After enrollment, participants were excluded before assignment failed to meet diagnostic criteria of the CAPS-5. One enrollee had an history of seizure and for another the motor threshold could not be found.
724916|NCT02158572||
724917|NCT02158546|Subjects were diagnosed with major depressive disorder (MDD) and had an inadequate response to 1 or 2 adequate courses of treatment with a commercially available antidepressant therapy (ADT) during the current major depressive episode (MDE). All subjects continued ADT for the duration of the study.|2 cohorts of subjects were enrolled: Group 1- subjects with baseline HAM-D17 score ≥ 20; Group 2- subjects with baseline HAM-D17 score 18-19. Only Group 1 was included in the efficacy analysis. Study included a 4-week pbo run-in period prior to the 6-week treatment period. In Group 1, 102 subjects did not meet criteria for randomization.
724918|NCT02158533|Subjects were diagnosed with major depressive disorder (MDD) and had an inadequate response to 1 or 2 adequate courses of treatment with a commercially available antidepressant therapy (ADT) during the current major depressive episode (MDE). All subjects continued ADT for the duration of the study.|This was a Sequential Parallel Comparison Design (SPCD) study comprised of 2 stages. In Stage 1 subjects were randomized to ALKS 5461 or placebo (2:2:9). In Stage 2 only placebo non-responders from Stage 1 were re-randomized to ALKS 5461 or placebo (1:1:1). One subject randomized to the PBO group in Stage 1 did not receive study drug.
724919|NCT02158520|This study was closed to enroll on November 19, 2015 after having enrolled 24 patients (12 patients per arm) due to the FDA approval of new agents for this patient population.|
724920|NCT02158494||13 subjects provided consent but did not enroll in the study at sites under UW-Madison purview.
724921|NCT02158442|First subject enrolled 17 Oct 2013. Study completion 28 Feb 2015.|
724922|NCT02158364|Participants took part in the study at 147 investigative sites in Japan, from 28-Mar-2007 to 20-Feb-2011.|Participants with a history of initial vaccination with live attenuated measles/rubella combined vaccine who received second vaccination with live attenuated measles/rubella combined vaccine as per routine medical practice were observed in this study.
724923|NCT02158273||
724924|NCT02158247||
724925|NCT02158091|Participants in the Phase I portion of the study enrolled in outpatient clinic setting from 6/27/2014 to 1/13/2015 and to the Phase II study from 4/14/2015 to 8/15/2016|
724926|NCT02158039|Participants were recruited in the Mayo Clinic Pancreas Clinic or the Mayo Clinic Interventional Endoscopy Unit in Rochester, Minnesota between April 2004 and August 2014.|Thirty-three subjects were enrolled, of whom 23 underwent study procedures and were considered accrued. Of the remaining 10, one withdrew and the other nine were excluded for a variety of per-protocol reasons including cysts found to communicate with pancreatic duct. Study was closed when an interim analysis showed low efficacy.
725030|NCT02151266||
741221|NCT01108809||
724927|NCT02157948|This study was conducted at 21 centers in Poland, Denmark, United States (US), and Canada. The first participant enrolled on 05 May 2014 and the last participant enrolled on 03 July 2014.|"Ambulatory postmenopausal women 55 years or older with a bone mineral density (BMD) equivalent to a T-score of ≤ 2.5 at lumbar spine, total hip, or femoral neck were eligible to enroll.
~Five hundred and forty-seven women were screened; 394 were enrolled and 153 did not meet eligibility criteria."
724928|NCT02157935||The enrollment number in the protocol section denotes the number of patients screened into the trial. Out of these 2026 patients screened, 1219 patients were randomized into the trial. This explains the discrepancy in patient number.
724929|NCT02157909|Subjects were recruited from 5 study centers located in the US.|Of the 134 enrolled, 2 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (132).
724930|NCT02157883|First subject enrolled: 6 November 2014; Last Subject Last Visit Part A: 3 April 2015 and Part B: 31 March 2016. Study performed at 15 sites across Asia, North America and Western Europe. Part A assessed effect of multiple doses of itraconazole on PK of AZD9291; Part B allowed subjects further access to AZD9291 and provided additional safety data.|The 39 patients started Period 1 and received treatment.
724931|NCT02157779|Participants were recruited from a wide range of sources during the time period of January 1, 2015 through January 31, 2018. The primary recruitment source was the Providence Veterans Affairs Medical Center, including the OEF/OIF specialty primary care clinic, the Returning Veterans Outreach Program (REVOC) and the PTSD Clinic.|Of the 112 enrolled, 94 completed both the first and second baseline assessments and were deemed eligible for the study. Of the 94 who completed their second baseline and were deemed eligible for the study, 92 were randomized to treatment. Two of the 92 randomized participants did not respond to outreach and did not start treatment.
724932|NCT02157623||
724933|NCT02157519|From 2/13/15-12/31/16, patients with diverse malignancies were recruited from the outpatient oncology clinics at Massachusetts General Hospital Cancer Center and three community affiliates (i.e., Mass General/North Shore Cancer Center, Mass General Cancer Center at Mass General West, Mass General Cancer Center at Emerson Hospital-Bethke).|Of the 212 patients enrolled in our study, 181 were randomized. There were 28 participants who dropped out of the study after enrollment but prior to randomization, and 3 participants who were lost to follow-up after enrollment but prior to randomization.
724934|NCT02157506||A total of 70 participants were enrolled of which only 46 participants received treatment. 24 were not treated due to screen failures, 3 of the 24 were randomized but not dosed due to other reasons.
724935|NCT02157376|"Overall, 343 patients were enrolled from 27 centres in China. The first patient entered the study on 15 July 2014 and the last patient completed the study on 18 February 2016.
~Of the 343 patients enrolled into the study, 311 (90.7%) patients were randomised to treatment."|32 patients were not randomised to treatment due to eligibility criteria not being fulfilled.
724936|NCT02157298|First participant enrolled: 06-Jun-2014; Last participant last visit of ST period: 02-Feb-2015; 266 participants were enrolled in 20 Japanese centers. 183 Japanese men or women aged >=20 years with inadequate glycemic control (HbA1c levels of >=7.2% to <11.0%) with diet, exercise and on stable dose of insulin +/- DPP-4 inhibitor were treated.|A 8-week wash-out period was applicable only for participants on ongoing anti-diabetic treatment at enrollment. A 2-week lead-in period was applicable for all participants.
724937|NCT02157168|Each month all newly enrolled female health plan members were randomly picked by the health plan (according to a randomization scheme provided by the study team) to be invited to work with a community health worker (CHW). Those not invited constituted the usual care control group. Recruitment began March 2015 and ended May 2016.|
724938|NCT02157116|This study opened to enrollment in May 2006 and closed in October 2009 due to failure to meet accrual goals for data analysis.|
724939|NCT02157103|Patients were recruited at Winship Cancer Institute and Emory University Hospital Midtown from January 2014 to April 2017.|
724940|NCT02156908||Please see NCT01474395 for a related parallel study involving 13 schizophrenia patients and 13 healthy controls. Participants in NCT01474395 were not enrolled in the current study, i.e., both studies included separate groups of participants
724941|NCT02156804||1009 participants were enrolled into the study , 1008 wrere treated, 1 participants was not treated due to withdrew consent
724942|NCT02156687||
724943|NCT02156674||
724944|NCT02156492||
724945|NCT02156466||A total of 41 subjects were randomized in the trial and included in the Safety analysis set.
724946|NCT02156271||A total of 75 subjects signed consent and were enrolled in the study. Of these, 23 (31%) failed to qualify to participate in the study based on screening assessments, 12 (16%) withdrew consent prior to randomization, and 4 (5%) dropped out before randomization. As a result, 39 subjects were randomized.
724947|NCT02156258||
724948|NCT02156167|Center contacted their patients, who received a Codacs device in another clinical trial by phone in October 2013|
724949|NCT02156076||Total 158 participants were enrolled out of which 26 participants were randomized and treated.
724950|NCT02155985|The first participant enrolled on August 18, 2014. The last participant enrolled on March 6, 2015.|Participants were randomized to the three study arms using a 1:1:1 allocation ratio with permuted blocks of size 6 and without institutional balancing. There was no stratification.
724951|NCT02155881|Participants took part in the study at 6 investigative sites in Russia from 12 August 2014 to 14 November 2014.|Participants with a historical diagnosis of seasonal allergic rhinitis (SAR) were enrolled in 1 of 2 treatment groups as follows: Ciclesonide 200 microgram (mcg) and Placebo.
724952|NCT02155829|Recruitment from WRNMMC = Walter Reed National Military Medical Center ; SVAMC = Syracuse Veterans Administration Medical Center|
724953|NCT02155738|Women were recruited form the Urogynecology offices of the University of Pittsburgh Medical Center (UPMC) and Allegheny Health Network (AHN) from July 2014 - August 2017.|
724954|NCT02155725|Between 10 April 2014 and 20 June 2018, 448 patients from 30 sites signed an informed consent.|During the pre-assigment period 11 patients withdrawn before treatment period. (1 treated with another IMP, 5 not treated, 2 no emergency consent signed, 1 no post inclusion consent signed, 2 refused to continue the study)
725148|NCT02141984|A total of 600 participants were expected to enroll in the study; however, due to low prevalence of JIA and ERA, only 28 participants were enrolled.|
725149|NCT02141867||
724955|NCT02155712||Cohort 1: 383 subjects/451 knees enrolled - 72 subjects/78 knees censored = 319 subjects/373 knees followed.Cohort 2: 205 subjects/229 knees enrolled - 75 subjects/82 knees censored = 134 subjects/147 knees followed.8 bilateral cases in Cohort 1 and 4 in Cohort 2 had 1 side censored and 1 side completed.These count in censored and followed counts.
724956|NCT02155660||2255 patients signed informed consent and were randomized to received treatment with benralizumab 10 mg,30 mg, 100 mg or placebo. One participant was excluded from the analysis. Therefore results are provided for 2254 participants.
724957|NCT02155647|First participant enrolled 03 July 2014. Clinical data cut-off: 03 March 2016 (Part A) and 02 May 2019 (Part B).|A total of 88 participants were enrolled in Part A of the study and a total of 116 participants were enrolled in Part B of the study. Participants enrolled in Part A were not eligible for enrollment in Part B.
724958|NCT02155608|Participants enrolled between 04/2015 and 03/2017. Participants were recruited through community advertisements and internet postings.|Potential participants underwent screening and those eligible returned for baseline assessment and randomization. Of 79 individuals screened, 64 met inclusion/exclusion criteria for participation. Two of these chose not to return after screening, most likely because they were only interested in ADHD assessment.
724959|NCT02155543||
724960|NCT02155465||
724961|NCT02155335||
724962|NCT02155322|This study enrolled Russian participants with malignant melanoma who had undergone surgical resection and lymphadenectomy.|
724963|NCT02155309|This study enrolled subjects who were active-duty military or reserves on active duty status between the ages of 18 and 59 from the Wright-Patterson Air Force Base located in Dayton, Ohio. The last subjects completed in August 2015.|For the Pharmacokinetics part, 21 subjects were screened, and 13 completed the pharmacokinetics portion. For Efficacy, 42 subjects were screened, and 23 completed, with one removed from efficacy tabulated results due to noncompliance with study protocol. All subjects randomized into treatment order with cross-over design.
724964|NCT02155283||
724965|NCT02155257||
724966|NCT02155101||
724967|NCT02155010||
724968|NCT02154906||44 subjects were enrolled but 3 withdrew prior to group assignment, leaving N=41 assigned to groups
724969|NCT02154763||
724970|NCT02154581|The recruitment started in January 2013 and ended in November 2016. All patient were recruited at the University of Texas Health San Antonio, Department of Periodontics.|No patient was excluded prior to group assignment.
724971|NCT02154477||
724972|NCT02154425|The study started to enroll patients in September 2014 and concluded in December 2015.|The Participant Flow refers to the Safety Set which consisted of 18 mothers, who were screened and had received at least one dose of Certolizumab Pegol (CZP), but only 17 mothers entered the study (Enrollment number), as one subject was a screen failure.
724973|NCT02154386||
724974|NCT02154347||
724975|NCT02154243||
724976|NCT02154139|Participants took part in the study at 157 investigative site in Japan from 26-Dec-05 to 31-Mar-10.|Participants with a historical diagnosis of premenopausal breast cancer (advanced or recurrent) who were treated with Leuprorelin Acetate 11.25 milligrams (mg) in daily medical practice along with adjuvant therapy were observed.
724977|NCT02154087|Subjects were enrolled at a single US investigation site, between July 14,2014 and November 2, 2014.|"Subjects entered a 2-week run-in; subjects whose wound radius decreased by < 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization.
~HP802-247"
724978|NCT02154061||
724979|NCT02154048|Because the required sample size of 60 subjects was not met, the study was terminated. Five subjects were enrolled from April 2012 to September 2013.|
724980|NCT02153983|213 adults were screened in the clinic and signed consent forms, of whom 77 were found eligible and studied with protocols.|
724981|NCT02153918||
724982|NCT02153905||The two groups below represent the Phase I period. Study was terminated prior to the phase II portion due to slow, insufficient accrual.
724983|NCT02153827|March 2014 - October 2015 participants were recruited from the local community via publicly displayed flyers.|none to report
724984|NCT02153788||
724985|NCT02153736||
724986|NCT02153723|"All participants were recruited between Aug 2014-Jan 2015, from the population treated at the Rett Center at Montefiore.
~Of 11 screened subjects, 10 met the inclusion/exclusion criteria and completed the trial. One patient was excluded due to prolonged QTc.
~Data analysis was performed after the first 10 participants completed the study."|
724987|NCT02153710||
724988|NCT02153671||
724989|NCT02153645||
724990|NCT02153632||
724991|NCT02153528||
724992|NCT02153489|This study was conducted by 3 investigators at 3 sites in Germany. The first patient was screened in April 2014 and the last patient visit was in June 2015|All patients who met the study entry criteria and completed the screening assessments and the 7-day run-in period were randomized. Nine (9/39) subjects were not randomized due to screening failure (primarily for non-fulfillment of inclusion/exclusion criteria)
724993|NCT02153476||
724994|NCT02153398|First subject enrolled on 24 June 2014 Last subject last visit on 04 April 2016. This study was conducted at a total of 20 sites in Japan.|Out of 55 enrolled subjects, 50 subjects were registered and 5 subjects were not registered. The reason of no registration was 'Did not meet inclusion/exclusion criteria' (5 subjects).
724995|NCT02153359||
724996|NCT02153346|Participants (par.) in this cohort study were randomly selected from the BD-Asthma/RESP registry in Quebec, with an asthma diagnosis between June 2014 and January 2015, more than 18 years of age, and followed at the outpatient clinics of Hôpital du Sacré-Coeur de Montréal (HSCM), a tertiary care clinic specialized in asthma.|187 participants were selected in the BD-Asthma/RESP database; 160 were contacted of which 101 participants were enrolled in the study. 59 refused to participate. Participants were not assigned to any investigational therapies.
724997|NCT02153112|Participants took part in the study at 12 investigative sites in Finland, Panama, and Colombia from 23 June 2015 to 20 June 2018.|Healthy volunteers (children, toddlers and infants) were enrolled to receive either one, two or three doses of 4 formulation of norovirus GI.1/GII4 bivalent virus like particle (VLP) vaccine.
725220|NCT02136810||
724998|NCT02153099|Participants took part in the study at 1 investigative site in the United States from 14 May 2014 (signing of informed consent) to 13 November 2014.|Healthy Volunteers were enrolled in 1 of 6 Dose Cohorts: (5 mg, 15 mg, 30 mg, 45 mg, 75 mg, 150 mg TAK-058) or placebo.
724999|NCT02153086|Participants took part in the study at 2 investigative sites in Japan from 01 March 2011 to 30 June 2014.|Participants with a historical diagnosis of insomnia which was associated with difficulty in falling asleep in daily clinical practice were enrolled in a single treatment group to receive ramelteon 8 milligram (mg).
725000|NCT02153073|Participants took part in the study at 570 investigative sites in Japan, from 29 May 2013 to 31 May 2017.|Participants with a historical diagnosis of hyperlipidemia were enrolled. Participants received interventions as part of routine medical care.
725001|NCT02152826||
725002|NCT02152761|384 subjects were screened, and 252 subjects completed Screening period. One was lost to follow-up after screening and did not attend any visits for treatment epoch therefore, 251 were recruited to study. 2 subjects died during Screening epoch (1 was reported as discontinued and 1 was reported as a screen failure)|251 subjects entered treatment epoch and were randomized to one of the three bimagrumab dose groups (70 mg, 210 mg and 700 mg) or the placebo group. 1 from the 210 mg group was randomized in error and did not receive study drug. Of the 250 subjects who were randomized and treated, 207 completed the 24 weeks treatment epoch.
725003|NCT02152696||
725004|NCT02152670||
725005|NCT02152631||Completers are defined as those participants who had progressive disease, death due to any cause or alive and on study at the end of study, but off treatment.
725006|NCT02152605|In this randomized, double-blind, placebo-controlled parallel study, eligible participants received Umeclidinium/Vilanterol(UMEC/VI) 62.5/25 microgram(mcg) once daily(via Dry Powder Inhaler[DPI]) or matching placebo(1:1) for 12 weeks.The study consisted of Run-in Period(7-14 days), treatment period(12 weeks) and follow up period(7+-2 days).|A total of 627 participants who met eligibility criteria were screened; 498 participants were randomized and 496 comprised the Intent to Treat population.
725007|NCT02152566||
725008|NCT02152540||
725009|NCT02152384||
725010|NCT02152371||All eligible participants entered a 2-week lead-in period. Only those participants who required further up-titration of the insulin glargine dose per treat-to-target (TTT) algorithm were randomized to one of two treatment groups.
725011|NCT02152345||Patients called into the hospital for potential renal transplants were approached for possible participation in the study if they agreed to discuss research and were eligible per study criteria. Patients were given the option to participate or decline.
725012|NCT02152137|Patients assigned to arm A will receive both paclitaxel and efatutazone; patients assigned to arm B will receive paclitaxel alone. However, please note that with update #2, arm B is closed and all patients should receive paclitaxel and efatutazone.|
725013|NCT02152007||
725014|NCT02151994|Study period : Date of first screening to last follow-up: 03 March 2011 - 13 January 2012;|
725015|NCT02151981|First patient dosed: 20 August 2014. Data cut off: 15 April 2016. The study was open for enrolment at 145 study centres, 126 centres in 17 countries randomised patients to treatment. Recruitment has closed and primary analyses have been performed but study is still on-going.|
725016|NCT02151903|Participants who, in the opinion of the Investigator, exhibited a beneficial effect without a dose-limiting toxicity (DLT) in the dose-escalation Study AO-101 (NCT01874288) (Main Study) were allowed to continue treatment with DI-Leu16-IL2 in this open-label extension study.|
725017|NCT02151877||
725018|NCT02151851|The study started to enroll patients in July 2014 and concluded in June 2016.|Participant Flow refers to the Randomized Set.
725019|NCT02151786|Participants took part in the study at 173 investigative site in Japan from 29 January 2007 to 31 March 2010.|In this study, participants were observed with a historical diagnosis of gastric ulcer or duodenal ulcer or acute stress ulcer or acute gastric mucosal lesion accompanied with bleeding, for whom oral administration of drug was not feasible and were enrolled in single treatment group: Lansoprazole.
725020|NCT02151773|Participants took part in the study at 152 investigative sites in Japan from 07 February 2006 to 30 April 2009.|Participants with a historical diagnosis of measles/rubella who received live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) as per routine medical practice were observed in this study.
725021|NCT02151682|The first participant was enrolled for Part 1 on 29 April 2015.|73 participants signed an informed consent form (assented). 1 participant withdrew consent and 2 did not meet in-/exclusion criteria. 70 participants were allocated to investigational medicinal product (IMP). 1 of the allocated participants was not treated, resulting in 69 participants who were dosed in Part 1.
725022|NCT02151643|Male/female subjects with dialysis dependent CKD on prescribed maintenance haemodialysis 3 times/week for 90d before Screening were recruited and randomised to receive PT20 or placebo. Prior to Screening, all subjects were taking at least 1 OPB for a minimum of 28d mean + serum phosphate level ≥ 4.0 mg/dL and ≤ 8.0 mg/dL for the preceding 28 days.|Subjects underwent stratified randomisation into 1 of the 4 PT20 dose groups or equivalent placebo group based pre-randomisation serum phosphate level (ratio of 8:8:8:13:13) - serum phosphate < 7.5 mg/dL were deemed to have a lower level of serum phosphate; serum phosphate ≥ 7.5 mg/dL were deemed to have a higher level of serum phosphate.
725023|NCT02151591||
725024|NCT02151526|This study was conducted at a single site in France between 07 June 2013 (First participant signed informed consent) and 26 February 2019 (Last participant last visit).|A total of 7 participants were treated in a single arm and completed the study. Data was planned, analyzed and reported separately for 3 participants with Sickle Cell Disease (SCD) and 4 participants with transfusion-dependent β-thalassemia (TDT).
725025|NCT02151487||Study takes place in routine clinical context. Subjects who received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants enrolled to the study.
725026|NCT02151461|Subjects meeting all inclusion criteria and no exclusion criteria were randomized to one of four treatment arms in the ratio of 1:1:1:1 (A:B:C:D). The randomization was stratified by fasting plasma glucose (≥126 mg/dL to <200 mg/dL, and ≥200 mg/dL to ≤220 mg/dL), as well as metformin experience. Yes/No history of abdominal side effects.|
725027|NCT02151448||
725028|NCT02151383||A total of 18 patients were assigned to study treatment. 6 patients were identified with GCP violations; hence, only 12 patients were included in disposition.
725031|NCT02151253|Eighty-one individuals signed consent and were screened for entry into this study. Thirty of these subjects met the inclusion/exclusion criteria but only 28 subjects were randomized to the study. (2 subjects withdrew consent prior to randomization).|
725032|NCT02151149|This multicenter study was conducted in the United States and enrolled participants at a total of 41 sites.|Participants ≥ 70 years old were randomized 1:1 to nab-paclitaxel and carboplatin on a 21-day treatment regimen or nab-paclitaxel and carboplatin on a 28-day treatment regimen; participants were stratified by Eastern Cooperative Oncology Group performance status (0 versus 1) and histology (squamous cell carcinoma versus non-squamous cell carcinoma)
725033|NCT02151110|Healthy adult male and female participants were recruited in a blinded manner. The study was conducted at one site in the United Kingdom.|A total of 259 participants were screened of which 200 participants were considered screen failures and the remaining 59 participants were randomized. Out of which, 56 participants were treated
725034|NCT02151058||
725035|NCT02150954||121 subjects enrolled. Of the 121 subjects 2 were screen failures and 2 subject were excluded after consent due to meeting exclusion criteria.
725036|NCT02150863||
725037|NCT02150837|This is a retrospective chart review of Medifast Weight Control Center (MWCC) clients from 21 centers that used either the Medifast 5 & 2 & 2 Plan or 4 & 2 & 1 Plan for weight loss between 1/2012 and 3/2014 - it is retropsective and observational in nature, so there was no recruitment involved. The plans were evaluated separately and not compared.|
725038|NCT02150759|from May 2014 to October 2016|
725039|NCT02150499||
725040|NCT02150460||
725041|NCT02150343||715 participants were randomised on to the study through the IRT. However, one participant was inadvertently randomised before eligibility had been confirmed by the PI, and was withdrawn due to a finding of inspiration/expiration wheeze before receiving any study medication. Therefore results refer to 714 participants throughout.
725042|NCT02150213|The purpose of this follow-up safety study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in Study BGG492A2207 and/or BGG492A2212.|The first period focused on contacting the patients, obtaining consent for follow-up, and conducting screening assessments. The second period of the study focused on performing the follow-up procedures, obtaining and interpreting the results, and referring the patient, if necessary, to an appropriate medical specialist.
725043|NCT02150109||
725044|NCT02150057||
725045|NCT02150044||"Each investigator was required to treat a minimum of two (2) subjects as lead-in procedures prior to enrolling subjects to the test cohort.
~Subjects enrolled to the lead-in cohorts were required to meet the same eligibility criteria and complete the same protocol-required procedures as the study cohort."
725046|NCT02149875|From January 2010 to May 2010, a randomized, double-blind trial was conducted, which involved patients with AIS in the Neurology Ward of Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Shanghai, China).|
725047|NCT02149836||
725048|NCT02149524||
725049|NCT02149420|A total of 27 patients were enrolled and randomized into the study at one site in Germany.|"The patients were enrolled in 2 sequential cohorts:
~Cohort 1: Six patients were randomized to receive a single dose iv of VAY736 at a dose of 3mg/kg or placebo at a 2:1 ratio.
~Cohort 2: Twenty one patients were randomized to receive a single iv dose of VAY736 at a dose of 10.0 mg/kg or 3.0 mg/kg or placebo at a 6:1:3 ratio."
725050|NCT02149342||
725051|NCT02149303|This is a retrospective observational study. 284 subjects were captured in the initial screening. 93 subjects were found not to meet the eligibility criteria and were excluded from the study, leaving 191 subjects eligible for study entry who were enrolled and included in the final study.|
725052|NCT02149290||
725053|NCT02149264|Subjects were recruited from 23 study sites in the United States.|Of the 940 screened subjects, 160 subjects were eligible to be enrolled into the study.
725054|NCT02149199|5721 patients enrolled; 5003 run-in, 718 not run-in; 3849 randomised, 1154 not randomised: 1022 did not meet incl/excl criteria, 4 adverse event, 5 severe non-compliance to protocol, 104 subject decision, 7 subject lost to follow-up, 12 other reason.|Eligibility was assessed at Visits 1, 2, 3. IC obtained at V1. At V2, eligible patients stopped prescribed asthma medication and entered a 2-4 week run-in period, treated only with SABA Bricanyl Turbuhaler 0.5 mg, 'as needed'. Lung function was performed by spirometry to confirm eligibility. Eligible patients were randomised at Visit 3.
725055|NCT02149173||
725056|NCT02149108|"The completed patients were on treatment (2 patients on Placebo, 3 patients on Nintedanib) at the data cut-off date 14JUN2016.
~The NOT Completed patients were off-treatment (380 patients on Placebo, 383 patients on Nintedanib) at the data cut-off date 14JUN2016."|
725057|NCT02148952||"320 facilities were assessed for eligibility. 200 were excluded (37 did not meet inclusion criteria, 163 did not have a matching facility identified).
~A total of 163,939 women were screened for eligibility; of those, 161,107 women were eligible for participation, and 157,689 women consented and were enrolled into the trial."
725058|NCT02148874|We enrolled 287 pregnant women between October 2013 and March 2017 at The Ohio State University Wexner Medical Center. Participants were recruited through prenatal clinics at Ohio State, campus newsletters and advertisements, and community online advertisements.|
725059|NCT02148835||
725060|NCT02148809||
725061|NCT02148718||A total of 100 participants were enrolled in the study; 14 participants did not receive study drug and are excluded from the analyses.
725062|NCT02148588||
725063|NCT02148523||
725064|NCT02148445||667 Screened for Eligibility 153 Did not meet inclusion criteria 116 Refused to participate 398 Randomized
725065|NCT02148302||
725066|NCT02148250||
725067|NCT02148211||
725068|NCT02148133|The study took place in 12 clinical sites in Japan|The target number of subjects enrolled was 20. A total 36 subjects were screened and 21 were enrolled in the study. All 21 subjects enrolled received at least 1 dose of study treatment and were included in the planned analysis sets (full analysis set, safety population and pharmacokinetic population).
725069|NCT02148107|The trial was terminated early therefore only the first 2 dose levels planned (0.5 mg and 3.0 mg) were administered. In addition, due to recruitment problems fewer subjects than planned were randomised into the placebo and BI 691751 3mg groups.|
725349|NCT02126306||
725070|NCT02147990|318 patients were enrolled at 67 study sites in North America, Europe, Asia and Australia. One patient was not included in the Safety Population due to failure of the study site to provide any dosing data in electronic data capture (EDC) before the site was closed.|
725071|NCT02147899||
725072|NCT02147834|5 subjects enrolled. First subjected enrolled 8/7/2015 and last enrolled on 11/19/2015. enrollment discontinued early by investigator due to futility.|
725073|NCT02147769||
725074|NCT02147691|Single site recruitment, private medical clinic.. Subjects 18 to 85 years of age with moderate to severe rosacea.Recruitment began May 2014 and ended November 2014.|Subjects could be excluded if less than 18 years of age, who does not have moderate to severe rosacea as determined by the Investigator Global Assessment (IGA), who has not completed the specified washout for medications as outlined in the protocol or who has been in another investigational study within 30 days of the Baseline visit.
725075|NCT02147613||
725076|NCT02147587||The zoster vaccine was administered at least 2 weeks (14 to 21 days) prior to initiation of CP-690,550 (tofacitinib) or placebo in rheumatoid arthritis (RA) participants on background methotrexate therapy.
725077|NCT02147561||
725078|NCT02147522|Patients were identified from medical charts or referred by care providers at three LAC-DHS community clinics with Patient Centered Medical Home (PCMH) care model, screened and recruited between April 2014 to May 2015.|
725079|NCT02147353|All patients were enrolled from September 2011 to December 2012.|
725080|NCT02147301|17 patients were enrolled and completed study.|
725081|NCT02147288|"Patients were recruited for the panniculectomy on negative pressure wound therapy (NPWT) and panniculectomy on Jackson-Pratt (JP) drains groups. Patients were not recruited for the remaining arm;s the manufacturer, Smith & Nephew, temporarily halted on the distribution of the device (Renasys*GO negative pressure wound management system)."|
725082|NCT02147197||
725083|NCT02147184|"Between 09/2010 and 12/2014, 287 participants were recruited into this longitudinal observational study, from outpatient and inpatient clinical settings as well as by advertisement and word of mouth.
~However, 23 of them either did not complete their intake visit or had to be excluded due to discovery of exclusionary conditions."|within one month of starting a SSRI or taking no psychotropics
725084|NCT02147158||
725085|NCT02147132||
725086|NCT02147093|A total of 41 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 40 subjects were dispensed a study lens. Of the dispensed subjects, 3 were discontinued and 37 subjects completed the study.|
725087|NCT02147067|Participants were recruited from Emory University Hospital in Atlanta, Georgia. Participant enrollment began in September 2014 and all study procedures were completed in June 2018.|
725088|NCT02146599||
725089|NCT02146482||
725090|NCT02146430|A total of 1293 participants who met all inclusion and no exclusion criteria were randomized to treatment at 158 sites in 11 countries from 12 Nov 2014 to 14 Jul 2016.|Eligible participants were randomized 1:1:1:1 to either DS-5565 15 mg every day (QD) given orally, DS-5565 15 mg twice daily (BID) given orally, placebo given orally as pregabalin placebo and DS-5565 placebo BID, or pregabalin 150 mg BID.
725091|NCT02146365|This study enrolled healthy Kenyan toddlers who participated in the randomized control trial VAC-010 (NCT02097472) whose parents provided consent to participate in VAC-011. In addition, 50 healthy toddlers who did not participate in the VAC-010 study were enrolled from the community as a pneumococcal conjugate vaccine (PCV)-primed-only open cohort.|Participants were enrolled sequentially into Cohort 1 (PATH-wSP 300 µg or control) and Cohort 2 (PATH-wSP 600 µg or control).
725092|NCT02146352||
725093|NCT02146326|Staff and clients were recruited from 2 community mental health centers. Up to 5 clients for each participating staff with adult caseloads were recruited. Enrollment occurred over 3 waves of recruitment at 2 sites between 2/24/2014 and 3/18/2016. Totals of 206 staff and 473 clients completed informed consent to participate.|"Mental Health Care Staff:
~206 completed informed consent: 14 were not randomized (12 did not complete the baseline survey, 1 withdrew, 1 resigned), 192 staff were randomized
~Mental Health Clients:
~473 clients completed informed consent: 4 were not linked to randomized staff (3 screen failures, 1 linked to staff not randomized),"
725094|NCT02146274||Observational survey
725095|NCT02146248|14 subjects were screened, and 11 signed consent and enrolled. One dropped out prior to the first HSG, and10 completed the 2 natural cycle HSG, 9 completed the COC HSG, 7 the DMPA HSG, and one a final post DMPA HSG after restarting COCs|
725096|NCT02146131||
725097|NCT02146105||
725098|NCT02146001|241 subjects were screened. Of these 190 did not meet inclusion criteria, 13 declined to participate, and 38 were eligible and enrolled in the study.|
725099|NCT02145754||
725100|NCT02145676||
725101|NCT02145468|The study was planned in 2 parts (Part A, N=3500 and Part B, N=22000). Upon completing Part A, a decision was made not to progress to Part B because of lack of efficacy. 3503 participants were randomized to Part A, 14 participants were excluded due to concerns over data integrity. 3489 participants were analyzed.|Eligible: >=35 years and hospitalized with type1 myocardial infarction (MI) and 1 additional predictor of cardiovascular (CV) risk; Excluded: unstable, known liver disease, life-threatening/opportunistic infection, severe renal impairment, NYHA III/IV or Killip III/IV CHF. All participants were followed until they withdrew consent to participate.
725102|NCT02145429|Because enrollment exceeded expectations, we were able to increase sample size from the original n proposed (120) to 181, thereby allowing us to carry out a fully powered confirmatory RCT. We obtained NIMH permission to change from an intervention development study to an RCT|
725103|NCT02145403||Two patients who consented never began treatment.
725104|NCT02145390||
725105|NCT02145299||
725106|NCT02145247||
725141|NCT02142504|Participants took part in the study at 10 investigative sites in the United States from 28 April 2014 to 14 January 2016.|Healthy volunteers were enrolled equally in 1 of 3 norovirus bivalent virus like particle (VLP) vaccine unique formulation treatment groups to receive: 2 formulation arms received 2 doses and 1 formulation arm received 1 dose.
725142|NCT02142387||
725143|NCT02142361||
725144|NCT02142283|See protocol|See protocol
725145|NCT02142153||
725107|NCT02145182|Fifty-nine centers in Australia, Brazil, Canada, Czech Republic, France, Germany, Italy, Spain, and the United States of America participated in this study. The study recruited participants who had been receiving dialysis for a median of approximately 50 months before undergoing transplantation and received a kidney from a deceased donor.|Written consent was provided prior to study-required assessments (N=333). Participants who passed screening (N=314) were vaccinated against Neisseria meningitidis. A total of 314 were randomized; of these, 286 underwent transplantation and received eculizumab or placebo. Two participants received placebo but withdrew prior to transplantation.
725108|NCT02145169|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
725109|NCT02145156|"Parent and young adult participants were recruited between June of 2014 and September of 2015 from one of five family health care clinics.
~Enrollment for the study was facilitated by 1) self-referral (passive recruitment), and 2) approach by research assistants (active recruitment)."|"Eligibility:
~Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26;
~Adolescent/young adult has not yet received all three doses of the HPV vaccine;
~Parent/young adult can read and converse in either English or Spanish"
725110|NCT02145078||
725111|NCT02145039||
725112|NCT02145026||
725113|NCT02144714||
725114|NCT02144701|Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 02/18/2013 and was closed to accrual on 04/22/2016.|We are reporting results on 33 eligible patients. 18 patients were deemed ineligible.
725115|NCT02144675|Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 10/31/2008 and completed on 01/06/2015. All participants visits were completed and the study was closed by the Principal Investigator on 04/26/2016.|
725116|NCT02144610|This study enrolled patients with critical limb ischemia from 69 sites across the United States, Canada, and Europe. The last patient completed in November 28, 2016.|Of the 98 subjects screened, 46 met the entry criteria and were randomized (1:1) into the study to receive AMG0001 or placebo as 4 sets of injections 2 weeks apart at Day 0, Month 3, Month 9, and Month 12.
725117|NCT02144519||Differences between the total number of children with outcome measures collected and the number of children measured at baseline is due to the use of a repeated-cross sectional design where a total of 2635 unique children were measured across 3 years and a subset with 2 or more years participating in outcome measurements.
725118|NCT02144337|Recruitment through clinic (single-centre). Postal invitation to all children meeting eligibility criteria.|Expression of interest request. Consent (parental) and assent (child) received from those who expressed an interest and agreed to participate.
725119|NCT02144285||
725120|NCT02144259||
725121|NCT02144233||
725122|NCT02144220|Recruitment was primarily online through mass email messaging from the Davis Phinney Foundation, internet listings on Fox Trial Finder, messages from PatientsLikeMe, Google AdWords in eligible states, and outreach to support groups.|"Individuals indicated their interest in participating by either visiting the Davis Phinney Foundation's funded research web page where individuals completed an online screening survey or by contacting study coordinators by phone or email."
725123|NCT02144155||
725124|NCT02144077|"Trial was conducted in Germany and United Kingdom with a total of 24 sites who recruited patients.
~Enrollment of patients started (first patient enrolled) 28-Jan-2014."|"Of the 394 patients screened in this study, 281 patients were randomized (138 patients to BF-200 ALA and 143 patients to methyl-aminolevulinate) and treated. 113 patients were excluded before randomization due to screening failure (104 patients), patient's decision (7 patients), and lost to FU and other reason (each 1 patient)."
725125|NCT02144012||Only 49 participants of the originally planned 561 participants were enrolled in the study at the time of study termination.
725126|NCT02143973||
725127|NCT02143947|A convenience sample of subjects was obtained via email and bulletin board postings at a local private university. Recruitment commenced 9/1/08 and ended on 2/1/09.|There were no significant events associated with this study.
725128|NCT02143843||
725129|NCT02143778||
725130|NCT02143713|"Participants who completed the 6-month Treatment Period in the pivotal Study M12-671 (NCT01931670) could enter this extension study.
~A total of 96 participants were enrolled at 148 sites in North and South America, Europe, Australia/New Zealand, and South Africa. One enrolled patient did not receive study drug and is not included in these results."|The study consisted of a 6-month Treatment Period and a Post-treatment Follow-up (PTFU) of up to 12 months. Participants who received elagolix in the pivotal study continued to receive the same dose for a further 6 months; participants on placebo in the pivotal study were randomized 1:1 to either elagolix 150 mg once daily or 200 mg twice daily.
725131|NCT02143648||
725132|NCT02143583||
725133|NCT02143310||
725134|NCT02143141|Recruitment and enrollment occurred between December 2011 and September 2013. The study was terminated due to extreme difficulty in recruiting patients willing to participate in the study.|
725135|NCT02143102||
725136|NCT02143024|45 people were referred to the study. 41 people were assessed, 4 were not assessed for eligibility. 18 were excluded; 10 did not meet inclusion criteria and 8 declined. A total of 23 people were randomized as part of the study.|
725137|NCT02142894||A total of 33 subjects were enrolled.
725138|NCT02142738||"Per protocol, it was planned that participants would be randomized 1:1 to receive either pembrolizumab or investigator-choice standard of care (SOC) chemotherapy and data analysis would be conducted on the two treatment arms: Pembrolizumab and SOC Chemotherapy.
~As of the 09 May 2016 data cutoff date, 189 participants were ongoing in the study."
725139|NCT02142712|Participants were recruited at Shands Hospital.|
725140|NCT02142608||"One participant was not dosed with BR55.
~Patient signed informed consent but did not receive investigational product. During pre-dose safety evaluations, it was discovered that patient may have potentially clinical significant abnormal ECGs (atrial fibrillation)."
725146|NCT02142049||
725147|NCT02141997||The study included a 30-day screening period.
725350|NCT02125877||Participants were randomized in a 1:1 ratio.
725351|NCT02125838||
725352|NCT02125734||
725150|NCT02141854||A total of 1661 patients with persistent asthma were screened and 882 patients enrolled. 154 patients were not randomized, most commonly (76 patients) because of not meeting randomization criteria.
725151|NCT02141659|Participants took part in the study at 7 investigative sites in Japan from 01 May 2014 to 20 April 2017.|Japanese participants with hormone treatment-naive prostate cancer were enrolled in this study to receive TAK-385 loading dose (320 or 360 milligram [mg]) and maintenance dose (80, 120 or 160 mg) in two parts: Part A, dose-escalation phase, cohorts 1-4 and Part B, dose-expansion phase, cohorts 1-2.
725152|NCT02141633||
725153|NCT02141620||
725154|NCT02141581||
725155|NCT02141555||
725156|NCT02141516|Subjects were enrolled at 4 centers in Italy, 3 centers in Poland, 3 centers in the Russian Federation, 4 centers in Spain and 4 centers in the United Kingdom.|All the enrolled subjects were included in the trial. One subject did not complete the study because he/she did not meet criteria for re-vaccination; two subjects met enrollment delay criteria since they required regular blood transfusions and they were unable to commit to visit windows (screen failure).
725157|NCT02141490||
725158|NCT02141451||
725159|NCT02141399|Subjects were entered into the study in one of 3 ways, based upon previous experience with a prior ALKS 5461 study: Subjects continuing from a prior ALKS 5461 study; Subjects who participated in the prospective lead-in for a prior ALKS 5461 study, but did not meet the entrance criteria; Subjects who did not participate in a prior ALKS 5461 study.|All subjects received ALKS 5461 during the course of the study as an adjunctive treatment for major depressive disorder. In addition all subjects were treated with background antidepressant therapy prescribed by the investigator.
725160|NCT02141360||Volunteer Control participants were scanned only for the purpose of operator training and calibrating the MRI device. No data was collected from these participants for the the purpose of analysis.
725161|NCT02141295||Participants with previously untreated metastatic colorectal cancer (mCRC) as defined by RECIST v1.1 were enrolled globally from 7 countries.
725162|NCT02141217|A total of 510 participants (par.) were screened; 472 were randomized to receive one of the two study treatments. Of the 472 par.; 235 par. were randomized to the amoxicillin + clavulanic acid (amx+clv) arm and 237 par. to the clindamycin (clin) arm.|Amongst the randomized par., 236 par. received amx+clv and 235 par. received clin as 2 par. randomized to the clin arm incorrectly received amx+clv and 1 par. randomized to amx+clv arm confirmed not consuming even a single dose of study drug.
725163|NCT02141204|The study was conducted at 8 centers in India.|"Out of 451 subjects enrolled in the study, 1 subject did not receive any study treatment and 1 vaccinated subject was eliminated from all analysis due to incorrect impartial witness.
~449 subjects were vaccinated and included in the Exposed Set, 419 subjects completed the study."
725164|NCT02140957||
725165|NCT02140788|Thirty-four subjects were consented to the study; however, were never randomized. The study was terminated in Feb 2013 and no data was collected or analyzed.|
725166|NCT02140775||Of the 138 patients who entered the study, 73 presented with significant fatigue and were started on armodafinil. Of those, 51 had an adequate response to the medication and were randomized to counseling. Another 65 patients did not have fatigue and were randomized directly to counseling. In total, 116 patients started counseling.
725167|NCT02140762|Subjects were recruited from 8 study sites in USA.|All enrolled subjects were included in the trial.
725168|NCT02140645|Existing data cohort design using data from the MarketScan database from May 2011 through December 2012. 492963 potential patients were identified in the database, but after removing patients who violated inclusion and exclusion criteria 166613 patients were actually analysed in the study.|
725169|NCT02140593||
725170|NCT02140567||
725171|NCT02140411||
725172|NCT02140372||
725173|NCT02140164|Five participants, ages 12 and older, with cystoid macular edema (CME) secondary to retinitis pigmentosa (RP) who meet the eligibility criteria will be initially accrued; however, up to an additional five participants may be enrolled to replace participants who may withdraw from the study prior to reaching Month 6|
725174|NCT02140060|Subjects were recruited from 19 study centers located in the US.|Of the 327 enrolled, 61 subjects were discontinued prior to randomization. This reporting group includes all randomized subjects (266).
725175|NCT02139982||
725176|NCT02139969||
725177|NCT02139943||A total of 614 participants were screened and 352 subjects (57.3%) were randomized to study drug. One subject randomized to placebo did not take any study drug and withdrew consent on the day of randomization.
725178|NCT02139878|74 individuals were screened for eligibility from the greater Charlottetown, Prince Edward Island, Canada area from March 2014 to May 2014.|20 of the 74 participants were randomized. Of those not randomized, 49 did not meet the inclusion criteria and 5 declined to participate.
725179|NCT02139826||One participant withdrew between arms following a non-serious adverse event - unlikely to be treatment-related
725180|NCT02139800||
725181|NCT02139644|A total of 1363 patients with persistent asthma were screened for enrollment into this study. 787 patients at 129 investigational centers in the US and elsewhere internationally met entry criteria and were considered eligible for enrollment into the study.|Patients were randomized 1:1:1:1:1 to one of the five treatment arms during the Treatment Period.
725182|NCT02139592|Participants took part in the study at 198 investigative sites in Japan, from 17 April 2014 to 30 June 2017. Registration period for patients was from 17 April 2014 to 30 September 2014.|Participants with a historical diagnosis of relapsed/refractory CD30+ Hodgkin's lymphoma (HL) or anaplastic large cell lymphoma (ALCL) were enrolled. Participants received interventions as part of routine medical care.
725183|NCT02139540|21 Participants were consented, however only 20 continued.|
725184|NCT02139358|Participants were enrolled at Moffitt Cancer Center October 2014 through October 2016.|
725185|NCT02139306|This study was conducted from 15 August 2014 to 02 November 2016.|
725186|NCT02139228|One center in China|All subjects enrolled into the parent V37_07E1 study were invited to participate in the trial.
725187|NCT02139176||
725353|NCT02125604||A total of 214 participants were screened and enrolled; 3 participants did not receive study drug (1 withdrew consent and 2 did not meet all inclusion/exclusion criteria). A total of 211 participants were included in the safety population.
725188|NCT02139137||47 individuals consented to participate in the study. Of those, 42 started the study and were randomized. The remaining 5 were not assigned to either condition. Intent to treat analyses are presented using last observation carried forward for all continuous measures.
725189|NCT02139124||
725190|NCT02139046|Participants took part in the study at 217 investigative sites in the United States from 18 April 2014 to 18 November 2015.|Participants with a diagnosis of gout were enrolled equally in 1 of 5 treatment groups: once a day placebo, febuxostat 40 mg extended release (XR), febuxostat 80 mg XR, febuxostat 40 mg immediate release (IR) or febuxostat 80 mg IR.
725191|NCT02139007|Sites were selected from 2 practice based research networks based upon self-reporting having a large number of women ≥ 65 years of age with a current alendronate prescription. Enrolled patient participants were randomized to continue or discontinue their current prescription. No drug was provided.|Period 1 refers to the study site recruitment period for the 9 sites that participated in the study. Period 2 refers to the patient recruitment period for the study. Randomization to treatment assignment was at the patient level. Sites recruited patient participants to both arms of the study. Two sites failed to enroll participants in either arm.
725192|NCT02138916||1656 patients randomized to Benralizumab 30 mg, Benralizumab 100 mg, or Placebo. All randomized patients were treated. 554 (33.5%) were randomized to Benralizumab 30 mg, 552 (33.3%) were randomized to Benralizumab 100 mg, and 550 (33.2%) were randomized to Placebo.
725193|NCT02138890|Multicenter study, with 4 centers in Belgium, Italy, Austria and Norway. The first subject was enrolled on 8 May 2014.|
725194|NCT02138838|This study was conducted at 32 centers in Belgium, Czech Republic, France, Germany, Greece, Hungary, Lithuania, Poland, Portugal, Russia Federation, Slovakia, Spain, Ukraine, and the United States.|Eligible participants were randomized to 1 of 2 treatment groups in a 1:1 ratio: cinacalcet daily in addition to standard of care (SOC) therapy or SOC therapy alone. Randomization was stratified by age group (6 to < 12 and 12 to < 18 years). Participants remained on treatment for 20 weeks or until the time of renal transplant or parathyroidectomy.
725195|NCT02138825|Overall, 229 participants were enrolled into the study centers in 19 countries worldwide, from 04-Jun-2014 (first patient first visit) to 14-Sep-2016 (last patient last visit).|A total of 147 participants were randomized and entered the main study phase, of whom 73 were assigned to riociguat and 74 to placebo.
725196|NCT02138786|"This multicenter study was conducted at 30 clinical investigative sites in the United States and Europe. Of the 30 investigative sites, 15 sites enrolled a total of 27 patients in the study.
~Date first patient enrolled: 14 November 2014
~Date last patient completed: 31 August 2016"|Of the 35 total patients screened, 8 patients were screen-failures. Of the 27 enrolled patients, one patient withdrew from the study prior to receiving treatment. Therefore, a total of 26 patients comprised the Safety population.
725197|NCT02138747|Recruited participants were male and female over 18 years of age with overactive bladder (OAB) symptoms and naïve to pharmacologic treatment. The study was conducted at 36 sites (8 sites in Canada and 28 sites in the US).|After screening, participants were randomized into 1 of 4 sequences in a 5:5:1:1 ratio (mirabegron/tolterodine extended release (ER), tolterodine ER/mirabegron, mirabegron/mirabegron or tolterodine ER/tolterodine ER. Each participant completed 2 double-blind treatment periods with a 2-week washout period between the two periods.
725198|NCT02138578||
725199|NCT02138461||
725200|NCT02138253|"Subjects were enrolled from 20 of 35 US sites that obtained IRB approval. First subject randomized Sep 2014, last subject last visit was 15 Feb 2018.
~A total of 114 subjects were screened, 64 subjects randomized with 41 subjects randomized to emricasan and 23 subjects randomized to placebo. Thirteen subjects discontinued the study."|
725201|NCT02138240||
725202|NCT02138227|While 273 participants registered, data were used from only 134 subjects, who had encounters pre- and post-intervention.|
725203|NCT02138214||117 participants consented. 27 participants were excluded from the study before assignment to arms (15 participants withdrew before surgery, 12 participants did not meet intraoperative inclusion criteria). 90 participants were allocated in 3 arms
725204|NCT02138136|Participants who completed the 3-month placebo-controlled study (NCT02042183) were invited to enroll in this safety extension study lasting an additional 9 months.|
725205|NCT02138110||
725206|NCT02138097|Existing data cohort design using data from the United Healthcare and MarketScan databases from May 2011 through July 2012|
725207|NCT02138006||
725208|NCT02137785||
725209|NCT02137772|A total of 738 participants were screened, 570 were randomized 2:1 letermovir:placebo, and 565 received at least one dose of study medication.|Screening could occur up to 15 days before Hematopoietic Stem Cell Transplant (HSCT) and no more than Day 28 post-transplant. From the time of screening to randomization, participants were tested weekly for Cytomegalovirus (CMV) viremia; a positive test resulted in exclusion from the study.
725210|NCT02137603||
725211|NCT02137512||
725212|NCT02137499||
725213|NCT02137486||
725214|NCT02137447||
725215|NCT02137382|50 patients consented, between January and March 2014.|41 of the 50 patients who consented were randomized; the 9 patients who were not randomized were screening failures.
725216|NCT02137369||77 were consented, 60 started treatments
725217|NCT02137226|A randomized, double-blind, parallel arm, multiple dose, active comparator trial to assess efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis. Patient received background methotrexate (MTX) treatment.|One patient was initially treated with Humira and discontinued prior to Week 24. This patient was mistakenly re randomized to BI 695501 but not treated. For safety set this was counted in Humira not re-randomized group (as treated), and for other analysis sets, this patient was counted in the Humira to BI 695501 group (as randomized).
725218|NCT02137096|The protocol was terminated due to poor enrollment.|
725219|NCT02136914|126 Participants with Parkinson's disease (PD) and Levodopa-induced Dyskinesia (LID) were randomized at 41 study sites in the United States and Canada. The first subject was randomized on 20 May 2014 and the last subject completed on 18 November 2015.|All randomized subjects who received ≥ 1 dose of study drug (123) were included in the Safety Analysis Population (60 placebo, 63 ADS-5102); all randomized subjects who received ≥ 1 dose of study drug and provided ≥ 1 postbaseline efficacy assessment (121) were included in the Modified Intent-to-Treat (MITT) population (58 placebo, 63 ADS-5102).
725221|NCT02136680|Patients were recruited between July 2014 and June of 2016. Enrollment took place in 2 separate HIV outpatient clinics where most clinic attendees were known to be HIV positive.|Potential participants were identified initially by age and gender, recruited and, if eligible, retained as study participants. We solicited referrals of eligible patients from primary care providers or designated clinic staff, and reviewed appointment schedules at both sites. Initial contact was made by the participant's primary care provider.
725222|NCT02136576||
725223|NCT02136498||
725224|NCT02136420||
725225|NCT02136238||
725226|NCT02136134||
725227|NCT02136004||
725228|NCT02135900||
725229|NCT02135861|This study included healthy volunteers (HV, group 1), participants (par) with heart failure (HF, group 2) and participants with acute decompensated heart failure (ADHF, group 3) who were hospitalized with evidence of pulmonary edema and received standard of care treatment.|Dynamic Contrast Enhanced-Magnetic Resonance Imaging (DCE-MRI) markers were used to measure vascular permeability and pulmonary edema in HV and par. with HF. Forty one par. were enrolled and 36 entered the study. Three par. did not continue due to habitus and 2 par. did not participate as they required clinical investigations.
725230|NCT02135848|This study was conducted at 12 centers in the United States from 15-October-2010 to 01-November-2011.|
725231|NCT02135692|This was an open-label, long-term study of mepolizumab 100 milligram (mg) administered subcutaneously (SC), in addition to standard of care (SOC), in eligible participants with severe eosinophilic asthma, who completed the MEA115661 Exit Visit (Visit 14). The study enrolled participants across 18 countries.|A total of 340 participants were screened for the study, of which one participant was screening failure, and 339 participants received the study treatment.
725232|NCT02135614|Participants were enrolled at study sites in Australia, Europe, Asia, New Zealand, and the United States. The first participant was screened on 09 June 2014. The last study visit occurred on 12 April 2017.|833 participants were screened.
725233|NCT02135445|Participants took part in the study at 23 investigative sites in the United States (US) and the United Kingdom (UK).|Participants with a diagnosis of localized prostate cancer were enrolled in 1 of the 2 treatment groups to receive TAK-385 120 milligram (mg) or degarelix 80 mg.
725234|NCT02135432||
725235|NCT02135146||
725236|NCT02135107||
725237|NCT02135094||
725238|NCT02135029||
725239|NCT02135016||
725240|NCT02134977|Participants took part in the study in 351 investigative site in Japan from 21 September 2011 to 31 March 2015.|Participants with a historical diagnosis of premenopausal breast cancer who were switched to leuprorelin acetate sustained-release 11.25 milligram (mg) injection kit from a 4-week adjuvant therapy with a luteinizing hormone-releasing hormone analog (LH-RHa) 1 month depot preparation as a part of daily medical practice were observed.
725241|NCT02134951||65 subjects were randomized, with results (Number started) reported for the 59 subjects randomized subjects with at least one valid scan
725242|NCT02134925|"For the baseline discrepancy, we projected to enroll 120 patients originally, but only enrolled 110 in the end. Of the 110, only 102 completed the study and were evaluable for the primary endpoint. Of the 8 dropouts, 7 were cancels and 1 patient was a withdrawal by subject."|
725243|NCT02134912||There is only one patient enrolled in this study. Patient was taken off study treatment by treating physician due to recent changes in standard of care. And patient never started protocol treatment. Thus we didn't enter any results for this only patient in the trial.
725244|NCT02134756||
725245|NCT02134717|Subjects with sarcoidosis stage II and active disease|Willing to undergo two Bronchoalveolar lavages
725246|NCT02134587||
725247|NCT02134522||
725248|NCT02134353||
725249|NCT02134314||
725250|NCT02134210||
725251|NCT02134184||
725252|NCT02134119||
725253|NCT02134028|Study was initiated at 365 sites in 27 countries. Participants who successfully completed treatment in studies DRI12544 (NCT01854047),EFC13579 (NCT02414854),EFC13691 (NCT02528214) and PDY14192 (NCT02573233) were eligible to continue their treatment in this extension study LTS12551. Total of 2282 participants were enrolled and treated in this study.|The Total study duration was maximum of 108 weeks for participants enrolled prior to amendment 4 approval and a maximum of 60 weeks for participants enrolled after amendment 4. Following amendment 4 (dated 31 Oct 2016) open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.
725254|NCT02134015|The first participant was randomized on 11 Jun 2014, and the last patient's last visit occurred on 11 Nov 2016. All randomized participants received study treatment and were included in both the Full Analysis Set and the Safety Analysis Set.|Of 537 patients screened, a total of 145 patients were randomized into this trial in 9 countries: United States (26 at 12 sites), Spain (19 at 5 sites), Hungary (18 at 4 sites), Italy (20 at 6 sites), Great Britain (11 at 5 sites), Poland (30 at 3 sites), Germany (16 at 6 sites), Canada (2 at 1 site) and Belgium (3 at 1 site).
725255|NCT02133781||
725256|NCT02133742||This study was planned to be conducted in two potential doses in the dose finding phase, Axitinib 3 mg + Pembrolizumab (MK-3475) 2 mg and Axitinib 5 mg + MK 3475 2 mg. However, no participant was enrolled in the Axitinib 3 mg + MK-3475 2 mg reporting group and all participants were enrolled in ''Axitinib 5 mg + MK-3475 2 mg'' reporting group only.
725257|NCT02133664||49 participants were excluded from the study for the following: did not meet inclusion criteria (i.e. test scores too high, colorblindness, unclear cognitive status), declined to participate, could not consent, lost to follow-up, and started fish oil.
725258|NCT02133534||
725259|NCT02133508|A total of 172 participants were enrolled; 16 participants had protocol violations; 156 participants were eligible.|
725260|NCT02133352||
725261|NCT02133235||
725262|NCT02133131|The current interim disclosure covers data up to 12 weeks after completing study treatment. The cutoff date for this initial disclosure is 12-Feb-2015. GT3 participants have completed treatment but are ongoing in follow-up.|
725263|NCT02133066||
725264|NCT02133001||
730083|NCT01787760||Of those 221 screened subjects, 56 were ineligible to participate in the study and 13 were eligible but not randomized to the study lens groups.
725265|NCT02132949||A total of 401 participants were enrolled, 199 in Cohort A and 202 in Cohort B. One participant in Cohort B who was human epidermal growth factor receptor 2 (HER2) negative and was enrolled by error, was excluded. Hence, 199 participants were included in Cohort A and 201 participants in Cohort B.
725266|NCT02132936|First Subject First Visit: 30-Jun-2014 Last Subject Last Visit: 04-Mar-2015|A total of 504 subjects were enrolled, 41 enrolled subjects were not randomised. 463 subjects were randomised as follows: 185 subjects to LEO 90100, 188 to calcipotriol BDP gel, 47 to foam vehicle, and 43 to gel vehicle
725267|NCT02132910||
725268|NCT02132884||
725269|NCT02132832||45 were enrolled (i.e., screened and consented), but 3 participants never returned to begin the study. Thus, only 42 participants began the study.
725270|NCT02132767||
725271|NCT02132754||Of 116 participants that were non-randomly allocated to treatment, 113 participants received treatment and were evaluable for all analyses.
725272|NCT02132676||
725273|NCT02132650||
725274|NCT02132637||
725275|NCT02132611||
725276|NCT02132598||
725277|NCT02132572||
725278|NCT02132533||
725279|NCT02132520||
725280|NCT02132468||
725281|NCT02132247||There were no significant events in the study between enrollment (i.e. determination of eligibility) and assignment to the Flector Patch arm.
725282|NCT02132195||Of 31 patients enrolled: 15 were randomized to receive ACTH, and 16 were randomized to No-treatment. There was an option for patients in No-treatment arm to elect to be placed on ACTH (rescue therapy). 13 patients in No-treatment arm used this option, and received ACTH as rescue therapy.
725283|NCT02132169|Subjects were recruited from four sites in the US.|There were 512 subjects enrolled, 24 subjects discontinued, and 488 subjects completed the study. Participant flow and baseline characteristics are presented for the 512 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.
725284|NCT02132117||
725285|NCT02131766||These results for 40 participants who completed the trial represent the combined results from participants at UVA, Mt. Sinai and Mayo Clinic (NCT02131766) combined with participants at University of Padua in Italy (NCT02008188).
725286|NCT02131662|The study was conducted at multiple centers in 12 countries worldwide between 15 May 2014 (first subject first visit) and 04 May 2016 (last subject last visit).|748 subjects were screened; 439 subjects were not randomized, the majority was screen failures. Therefore, 309 subjects were randomized.
725287|NCT02131636||
725288|NCT02131532|The recruitment was started in July 2014 and completed in October 2014. Participants were recruited through three approaches, including patients discharged from the Stroke Ward, patients visiting the Stroke Clinic, and those visited by the stroke nurses in the community.|
725289|NCT02131402||There were 60 subjects enrolled and fitted with the study lenses. All sixty subjects completed the trial (i.e. no discontinuations).
725290|NCT02131324||"Washout was needed at Screening Visit if prohibited therapies were in use.
~The screening adrenocorticotropic hormone (ACTH) stimulation test was conducted at least 14 days and no more than 28 days prior to the Baseline Visit."
725291|NCT02131311||145 subjects entered the 2-week baseline phase and 55 subjects dropped before treatment
725292|NCT02131272|The following 12 countries screened subjects (no. of sites that randomised subjects within parentheses): Brazil (1), Germany (1), India (3), Israel (1), South Korea (1), Malaysia (3), Mexico (1), Russian Federation (1) Taiwan (3), Turkey (3), United States (6), Hungary (0). A total of 24 sites in 11 countries randomised subjects to treatment.|Subjects continued treatment with metformin on their pre-study dose(s) throughout the trial.
725293|NCT02131259|Case Report Form (CRF) collected for 1605 patients, 1602 added in safety set. 1 patient excluded due to out of contract period, 1 due to no treatment (with GIOTRIF) and 1 patient received (GIOTRIF) treatment before registration (total 3 patients excluded from the safety set). Participant flow is based on safety set.|This was a non-interventional, prospective, observational, single arm study based on new data collection.
725294|NCT02131233||These results stop at Week 96.
725295|NCT02131155||
725296|NCT02131129|The recruitment period for the study was from 04/2014-09/2016. Recruitment took place at the Prevention and Recovery Center for Early Psychosis, an Eskenazi Health - Midtown Mental Health Clinic and at local community mental health centers in the Indianapolis area.|
725297|NCT02131064||A total of 574 participants were screened at 65 sites in 10 countries, of which 444 participants were randomized in two arms: Trastuzumab (TCH) + Pertuzumab (P) (Arm A) and Trastuzumab Emtansine (TDM1) + P (Arm B)
725298|NCT02130999||
725299|NCT02130986|Subjects were enrolled in the Emergency Department (ED) if they had a primary clinical diagnosis of acute Lower Respiratory Tract Infection [LRTI] (< 28 days duration) and their key clinician was willing to consider Procalcitonin (PCT) result in Antibiotic (ABX) decision making.|Only 8 patients (4 in each arm) were entirely excluded because they withdrew all consent to participate.
725300|NCT02130765||
725301|NCT02130635||This study was comprised of two parts. In Part A, participants were randomized to active or placebo treatment in a 3:1 ratio and in Part B, to placebo or one of the six doses of active treatment in an equal ratio. Each part comprised a separate sample of participants.
725302|NCT02130622|Participants were recruited from the gastroenterology clinic at Dartmouth-Hitchcock Medical Center at the time of routine appointments.|
725303|NCT02130583|Participants in this study were adolescents who were hospitalized at a psychiatric hospital in Rhode Island due to concern of suicide risk. The last participant completed the study procedures in September 2016.|
725304|NCT02130570|BWH participants were enrolled from 8/21/2013 to 5/15/2015. MGH participants were enrolled from 9/18/2013 to 10/13/2015. Participants were recruited while they were inpatients on the medical or surgical services at either BWH or MGH.|A total of 141 eligible participants were enrolled to 1 pilot practice at Brigham and Women's Hospital and 1 pilot practice at Massachusetts General Hospital. These participants received the study Intervention so that we could troubleshoot and refine the Intervention procedures. These participants are NOT counted in the final enrollment number.
725305|NCT02130557||Data reported was based on primary analysis date (11 August 2016).
725306|NCT02130284||
725307|NCT02130258|All subjects were recruited from the MGH Center for Pain Medicine in Boston, MA.|"23 subjects were initially enrolled. 3 subjects were withdrawn before assignment to groups for the following reasons:
~sensory deficits at the site of QST and inability to complete questionnaires on own
~did not receive ESI which is a requirement for the study"
725308|NCT02130193|This was a 2 part study. In Part A, an open label, single arm, participants (par.) received danrixin 50 milligrams (mg) twice daily (BID) for 2 weeks. In Part B, a randomized (1:1), double-blind (sponsor unblinded) placebo controlled on top of standard of care study, par. received DNX 75 mg BID in one arm and placebo in the other arm for 52 weeks.|A total of 19 par. in Part A were screened (10 failed) and 9 were randomized in a 2-week treatment period (TP) followed by a follow-up visit (FU) at 7- 14 days after last dose. A total of 127 par. in Part B were screened (34 failed) and 93 were randomized in a 52-week TP followed by a FU at 14- 28 days after last dose of the study.
725309|NCT02130063||
725310|NCT02130024|Patients were recruited and enrolled from 24 sites located in Australia.|This reporting group includes all patients randomized to treatment.
725311|NCT02129777|Participants were enrolled into the double-blind treatment evaluation at 17 investigative sites in Canada, Denmark, Germany, Latvia, and Poland. Only those sites in Denmark, Latvia and Poland participated in the extension period which included open-label treatment with study medication.|Participants with diagnosis of moderate to severe plaque psoriasis without clinically significant lung/respiratory disorders were screened for enrollment into the study.To fulfill screening requirements,chest X-ray was carried out prior to Baseline visit which included assignment to the double-blind study treatment and first dosing with study drug.
725312|NCT02129725|Subjects consented to give muscle biopsy|
725313|NCT02129660||
725314|NCT02129608||
725315|NCT02129556||
725316|NCT02129478||
725317|NCT02129205||
725318|NCT02129192||
725319|NCT02129062|Recruitment Period: April 15, 2014 to November 12, 2015. All recruitment done in medical clinics.|
725320|NCT02128997||
725321|NCT02128932|The trial was conducted at196 sites in 14 countries. Argentina: 3 sites; Croatia: 3 sites; France: 5 sites; Germany: 11 sites; India: 12 sites; Macedonia: 3 sites; Mexico: 3 sites; Netherlands: 3 sites; Romania: 5 sites; Slovakia: 5 sites; Slovenia:3 sites; South Africa: 4 sites; United Kingdom: 13 sites; United States: 123 sites.|Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin ≥1500 mg or maximum tolerated dose and SU≥ half of maximum allowed dose according to national label) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose.
725322|NCT02128919||
725323|NCT02128867||
725324|NCT02128828||
725325|NCT02128763||
725326|NCT02128724||
725327|NCT02128542|Participants were enrolled at a total of 15 study sites in the United States The first participant was screened on 04 June 2014. The last study visit occurred on 22 June 2015.|113 participants were screened.
725328|NCT02128490|Participants took part in the study at 65 investigative sites in the United States from 5 May 2014 to 23 October 2015.|Participants with a diagnosis of gout were enrolled equally in 1 of 5 treatment groups once a day: placebo, febuxostat 40 mg extended release (XR), febuxostat 80 mg XR, febuxostat 40 mg immediate release (IR) or febuxostat 80 mg IR.
725329|NCT02128269||
725330|NCT02128217|Participants were enrolled at 12 different study sites in the United States. For Cohort 1, the first participant enrolled on 30 May 2014; the last participant enrolled on 7 October 2014. For Cohort 2, the first participant enrolled on 31 August 2015; the last participant enrolled on 27 September 2015.|
725331|NCT02128074||
725332|NCT02127970||A total of 698 participants were randomly assigned in a 1:1 ratio to the following treatment groups: Single-dose dalbavancin group, received a single dose of dalbavancin intravenous (IV) on Day 1, and a matching placebo IV on Day 8; Two-dose dalbavancin group, received dalbavancin IV on Day 1 and Day 8.
725333|NCT02127931|Participants were recruited from a highly selective college|Company no longer exists, and no longer has access to data collected. Only information from draft publication available.
725334|NCT02127892||
725335|NCT02127723||
725336|NCT02127710|111 patients were enrolled; 109 patients received at least one dose of AZD6094 administered orally (po). Two patients withdrew prior to receiving any study drug. The study was conducted at 23 international sites in the United States, Canada, United Kingdom and Spain.|All patients were required to provide an archived or fresh tumour sample at enrollment to confirm eligibility, and for performance of the c-MET biomarker analysis. c-MET biomarker results determined the subgroup placement for data analysis as follows: c-MET positive (n=44), c-MET negative (n=46), and c-MET unknown (n=19).
725337|NCT02127632||
725338|NCT02127567||
725339|NCT02127372|Patients with Advanced Non-Small Cell Lung Cancer were enrolled from November 2004 to April 2009. The study was closed due to poor accrual.|"Overall, 72 subject signed a consent form and 43 went on to start treatment on study.
~Of the 24 subjects who signed a consent form for Phase 1, 9 were screen failures and did not start study treatment.
~Of the 48 subjects who signed a consent form for Phase 2, 20 were screen failures and did not start study treatment."
725340|NCT02127307|In the present study GE-122-016 (NCT02127307), participants previously administered AdreView™ (123ImIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were followed to identify who died during 60 months of follow-up from the date of administration of 123I-mIBG.|Of 964 heart failure (HF) participants included in the efficacy population of MBG311 (NCT00126425) and MBG312 (NCT00126438), 694 were contacted in this study as 101 participants died and 169 were not contacted due to participant consent not obtained and/or some sites declined to participate.
725341|NCT02127281||
725342|NCT02127125||69 participants were screened, 8 were screen failures, so not randomized.
725343|NCT02126969||
725344|NCT02126839||The run-in period (days -14 to Day -1) was conducted in a single blind manner with respect to the Placebo MDPI treatment (2 inhalations QID at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime), so that the patient did not know which treatment was administered.
725345|NCT02126826||
725346|NCT02126748||
725347|NCT02126670||
725348|NCT02126319||
725354|NCT02125461|Patients were randomized between 09 May 2014 and 22 Apr 2016 in 235 study centers across 26 countries. 2 interim analysis have been conducted for this study with data cut-off (DCO) dates as indicated. Results are reported for analysis of progression-free survival (PFS) (DCO: 13 Feb 2017) and analysis of overall survival (OS) (DCO: 22 Mar 2018).|Eligible patients with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) were randomized in a 2:1 ratio to receive either durvalumab (MEDI4736) 10 milligrams (mg) / kilogram (kg) every 2 weeks (Q2W) or placebo.
725355|NCT02125331||
725356|NCT02125292||
725357|NCT02125279||A total of 88 participants were screened. Only 54 participants out of 88 were enrolled and received study drug, of which 41 participants completed the study.
725358|NCT02124889||
725359|NCT02124863||
725360|NCT02124811|Participants were recruited between February 2015 and November 2016 from the Persistent Symptoms: Treatment, Assessment and Recovery (PSTAR) Clinic at Grady Memorial Hospital in Atlanta, Georgia.|Eighteen individuals were screened and 8 of these did not meet eligibility criteria or were lost to follow up prior to beginning the study treatment, resulting in 10 participants who began treatment.
725361|NCT02124798|This was a study in participants with Systemic Lupus Erythematosus (SLE). The study was conducted at 27 centers in the United States from 20 May 2014 to 13 April 2015.|A total of 119 participants were screened out of which only 95 were enrolled to the study treatment. 25 were screen failures the reasons for which were did not meet inclusion/exclusion criteria (23), lost to follow up (1), withdrew consent (1).
725362|NCT02124707|Subjects were recruited from the University of North Carolina at Chapel Hill Hospitals and Bon Secours Virginia Health System June 16, 2014 to February 27, 2017|Nineteen subjects were consented to this trial. Of these, 3 were not eligible, 2 withdrew before treatment. 14 subjects were treated.
725363|NCT02124603||
725364|NCT02124564|The study started to enroll patients in April 2014 and concluded in November 2017.|Participant flow refers to Safety Set including all subjects which took at least one dose of study medication.
725365|NCT02124512||
725366|NCT02124460||
725367|NCT02124304||
725368|NCT02124265|Participants aged 18-65 years with 20-65% of total body surface area (TBSA) partial- to full-thickness burns were recruited from the burn unit from May 2013 through May 2015.|
725369|NCT02124161||882 participants who were greater than or equal to (>=) 50 years of age and previously vaccinated with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) were randomized in this study but 6 participants (2 participants in 13vPnC+QIV/Placebo arm and 4 participants in Placebo+QIV/13vPnC arm) were randomized but not vaccinated.
725370|NCT02124122||
725371|NCT02124083||
725372|NCT02124044||
725373|NCT02124018|From April 2014 to July 2018, 575 consecutive patients were enrolled in the seven Departments of Cardiology participating in the study|
725374|NCT02123966|Participants were enrolled from July 2014 to November 2016.|
725375|NCT02123849||
725376|NCT02123797|The recruitment process included a patient population of those receiving care and/or treatment for their lung cancer from physicians and clinics within the Baptist Cancer Center network, including sites in the Memphis metropolitan area, Oxford, Mississippi, and Jonesboro, Arkansas. Dates of recruitment were from October 2014 through May 2016.|Patient eligibility criteria: diagnosis of lung cancer within 6 weeks of screening date, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, no previous lung cancer diagnosis, and no diagnosis of other cancers within the past 5 years. Caregivers and clinical care providers (doctors/nurses) of eligible patients also gave consent.
725377|NCT02123745||
725378|NCT02123576||
725379|NCT02123511||
725380|NCT02123472||
725381|NCT02123459||
725382|NCT02123446||
725383|NCT02123329|Between February 2013 and December 2014, the study pharmacists assessed 450 smokers for eligibility in the study. Of them, 361 (80.2%) met the study inclusion criteria. A total of 314 cigarette smokers consented to enroll in the study and were randomized into one of two study groups|
725384|NCT02123251|The study recruited 320 eligible patients from Kaiser Permanente Hawaii. Participants were randomly assigned into the intervention or control group with 159 and 161 in each group respectively. The randomized control trial (RCT) was conducted from May 2014 to December 31, 2015 with rolling enrollment from May 2014 to January 2015.|
725385|NCT02123134|A total of 55 subjects were randomized to either ATX-101 or placebo at a ratio of 1:1. A total of 28 subjects received ATX-101 and 26 subjects received placebo; 1 subject (803-003) was randomized to placebo but was not treated with placebo.|
725386|NCT02123017||
725387|NCT02122952|Recruitment period May 2014 - Dec 2015|30 day screening period prior to enrollment and dosing.
725388|NCT02122887||
725389|NCT02122796||
725390|NCT02122783||This is a cross over study - so all participants received both interventions (i.e. were in both study arms).
725391|NCT02122770|Participants took part in the study at 4 investigative site in the United States from 01 April 2014 to 05 June 2017.|Participants with advanced solid tumors were enrolled in this study to receive MLN4924. This study included 2 parts: Part A (drug-drug interaction)- participants received MLN4924 with fluconazole or itraconazole and in Part B (standard of care)- participants received MLN4924 in combination with docetaxel or carboplatin and paclitaxel.
725392|NCT02122549||
725393|NCT02122471||The data are correct and approved in the NDA. 1410 randomized subj.including 95 (index and non-index) duplicate subj. The index subj (22) were duplicate appeared the first time in the study and the same subject appeared in other studies or sites were non-index duplicate (73) who were excluded in the ITT population (1337).
725394|NCT02122445|Low back pain patients, evaluated within the first 2 initial visits of treatment at an outpatient rehabilitation clinic.|
725395|NCT02122406||
725396|NCT02122380|55 patients were screened for eligibility at Vanderbilt University Medical Center.|23 out of 55 participants were randomized. Of those not randomized, 23 were did not meet inclusion criteria and 9 declined to participate.
725397|NCT02122341||
725398|NCT02122146||A total of 38 patients were screened, among which 31 were assigned to study treatment.
725399|NCT02121912||
725400|NCT02121860|This was an open-label, multicenter, parallel-group study to compare the PK and PD of IDN 6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers (subjects with normal hepatic function).|A total of 37 subjects were dosed. One subject was dosed twice at two different centers, so the analyzed sample size was 36 subjects: 12 subjects with mild, and 8 subjects each with moderate and severe hepatic impairment, and with normal hepatic function.
725401|NCT02121847||
725402|NCT02121834||
725403|NCT02121808|Recruitment was held between April 14th 2014 and June 26th 2014 by telephonic solicitation and through the preoperative bariatric clinic of our institution.|
725404|NCT02121795|Participants were enrolled at study sites in North America and Europe. The first participant was screened on 06 May 2014. The last study visit occurred on 1 March 2019.|780 participants were screened.
725405|NCT02121756||
725406|NCT02121535|The trial was performed as an open-label, randomised, single-dose, two-sequence, four period replicated crossover design. A total of 72 healthy male subjects were randomised to 2 groups (Treatment sequences 1 or 2).|
725407|NCT02121522||This is a open-label, single-arm, 4-week proof-of-concept study.
725408|NCT02121509|"The study is conducted in two parts:
~Part 1 of the study was conducted in fasting conditions. Part 2 of the study was conducted in fed conditions."|
725409|NCT02121483||
725410|NCT02121418||
725411|NCT02121392||
725412|NCT02121301||
725413|NCT02121262||
725414|NCT02121210|The study was conducted at 27 centers in 7 countries. A total of 201 participants were screened between 03 June 2014 and 20 October 2014.|Of 201 participants, 69 participants were screen failures due to exclusion criteria met and inclusion criteria not met. 132 participants were randomized in 1:1 ratio to either sarilumab 150 mg every two weeks (q2w) or sarilumab 200 mg q2w.
725415|NCT02121067||
725416|NCT02121041||
725417|NCT02120950|The study was conducted at multiple centers in 8 countries worldwide starting from 29 May 2014 (first subject first visit). Primary completion reached on 12 Aug 2016.|Overall, 428 subjects were screened, of them 95 were failed in screening. Remaining 333 subjects received at least one treatment. Of them, 15 subjects discontinued study participation before week 12 and were not randomized. Remaining 318 were randomized.
725418|NCT02120924||
725419|NCT02120898||A total of 467 participants were enrolled and randomized in 2:2:1 to receive generic imiquimod cream 2.5%, zyclara® (imiquimod) cream 2.5%, or vehicle cream.
725420|NCT02120833||
725421|NCT02120794||
725422|NCT02120716||
725423|NCT02120664|First subject enrolled: 14 April 2014; Last subject completed: 18 September 2015|
725424|NCT02120625||
725425|NCT02120456||
725426|NCT02120443||
725427|NCT02120417|This study was conducted at 72 study centers (65 in the United States and 7 in the European Union [3 in the United Kingdom, 3 in Spain, and 1 in Portugal]).|
725428|NCT02120352|The study was conducted across 50 sites in five countries (United States, Canada, France, Germany and Spain). The results presented are based on interim analysis at Week 32 of maintenance phase.|Study consisted of 28 days Screening Period, 20 weeks Induction Period, 96 weeks Maintenance Period (MP), Extension Period (EP) and 52 weeks Long-Term Follow Up Period (LTFP). A total of 309 participants were enrolled in the study and entered in induction period. Of which 288 completed and 286 were qualified and randomized into the MP.
725429|NCT02120300|Participants were enrolled at study sites in the United States. The first participant was screened on 10 April 2014. The last study visit occurred on 17 August 2015.|147 participants were screened.
725430|NCT02120287||
725431|NCT02120261||3 participants who were enrolled did not start the study.
725432|NCT02120157||Three patients screen failed due to: One patient could not report on whether the marrow is cellular or at least 20 percent cellularity, one patient had poor liver function, and the one patient's Alanine aminotransferase (ALT) was over the study limit.
725433|NCT02120027|The first patient was screened on 26th February 2014 and the first patient randomised on 24th March 2014. The last patient completed the study on 03rd November 2015. The study was conducted at 139 clinical sites in 9 countries (Czech Rep, Germany, Hungary, Latvia, Poland, Slovakia, Sweden, the USA and the United Kingdom)|A total of 1300 patients entered a 2-week Screening period, 1072 entered the qualifying 2-week Run-in period and 558 of them were randomised. Two patients randomised to placebo never took the study medication.
725434|NCT02120001|Four patients were found ineligible.|
725435|NCT02119936|Women were recruited from the antepartum unit of the North Carolina Women's Hospital to participate in the study.|
725436|NCT02119871|Patients who were scheduled for elective open left heart surgery at Skåne University Hospital were eligible for inclusion.|
725437|NCT02119676|In Substudy 1, the first subject was enrolled on 29 OCT 2014, and the last subject was enrolled on 23 JUL 2015. In Substudy 2, the first subject was enrolled on 05 NOV 2014, and the last subject was enrolled on 02 OCT 2015.|Substudy 1; 4 participants were assigned a randomization number but were not given study drug because of clinical deterioration or withdrawal of consent. Substudy 2; 9 participants were assigned a randomization number, but weren't given study drug due to clinical deterioration, withdrawal of consent or not meeting all of the eligibility criteria.
725438|NCT02119663|Participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were randomized in the study.|Treatment was started as soon as possible after randomization (within 3 days) and consisted of continuous 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered for the entire cycle.
725439|NCT02119650|This study was conducted at 42 study centers (25 in the United States, 4 in Spain, 3 in France, 3 in Portugal, 2 in Denmark, 2 in Germany, 2 in Italy, 1 in the Netherlands).|
725440|NCT02119455||
725441|NCT02119442||
725442|NCT02119325|Participants were mainly recruited from the study site database.|Of the 210 participants screened, 114 participants were not randomised. The reasons for the same were: not meeting study criteria (n=42), lost to follow-up (n=5), and other reasons (n=67).
730084|NCT01787604||
725443|NCT02119299||Per protocol, there were two screening visits prior to the run-in visit to assess subject eligibility and oral health. A total of 4 visits (2 screening visits, 1 run-in visit and 1 wash-out visit) were included prior to the baseline visit.
725444|NCT02119286|Participants ≥ 40 years of age with history of chronic obstructive pulmonary disease (COPD) and a smoking history of ≥ 10 pack-years were enrolled in the study. Participants completed a 4-week run-in period, in which they received fluticasone furoate 100 micrograms(µg)/vilanterol 25 µg, followed by a 12-week treatment period and 1-week follow-up.|A total of 620 participants (pars.) were randomized to study treatment. However, only 619 of these 620 participants compromised the Intent-to-Treat Population, defined as all participants randomized to treatment who received ≥ 1 dose of randomized study medication in the treatment period.
725445|NCT02119260|This study is a placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose (SD) and repeat, ascending doses (RD) of GSK2798745 in healthy participants (par.) and stable heart failure par. This study was conducted at two centers in the United Kingdom|Sixty one par. entered this 5-cohort study where Cohorts 1-3 were healthy par. and Cohorts 4 and 5 were par. with stable heart failure. Of those,1 par. was withdrawn pre-dose due to issues with ECG values. In Cohort 1 and 2, par. were randomized to sequence and in Cohorts 3, 4 and 5 par. were randomized to drug or placebo
725446|NCT02119156|This was multi-center study to evaluate temporary discontinuation of belimumab 10 milligram(mg)/kilogram(kg) for 24 weeks followed by reintroduction of belimumab 10 mg/kg Intravenous (IV) for 28 weeks, in participants with low Systemic Lupus Erythematosus (SLE) disease activity receiving belimumab plus standard of care.|A total of 80 participants were enrolled for this study. Participants were enrolled across 20 sites in China, Japan, Korea and the United States.
725447|NCT02119104||
725448|NCT02119026||
725449|NCT02118961||
725450|NCT02118896|This multicenter study was conducted in 128 centers in 24 countries worldwide. The Principal Investigator at each study site was a medical doctor experienced in the treatment of transplant participants.|Only patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) and had received at least one dose of study medication were enrolled.
725451|NCT02118831|patients were recruited at a single private medical clinic between May of 2012 through October 2013|
725452|NCT02118792||
725453|NCT02118766||
725454|NCT02118714||The Safety Analysis Set included all enrolled participants who received >= 1 dose of Atrasentan (N = 20); of these 20, 6 participants entered an Observational Period of up to an additional 52 weeks.
725455|NCT02118610||
725456|NCT02118597|A total of 19 participants were enrolled in 8 study centers.|
725457|NCT02118441||
725458|NCT02118428||227 total were enrolled, but one participant was ineligible prior to randomization.
725459|NCT02118012||
725460|NCT02117999|Eligible patients were randomized after enrolment, with allocation ratio of 2:1, into either the study or control group|Block randomization strategy was used to randomize units with comparable baseline Kmax values in either group.
725461|NCT02117934||
725462|NCT02117687||
725463|NCT02117648||
725464|NCT02117570||In Stage 1, 42 participants aged 50 to 64 years were randomized. After at least 14 days of post-Dose 2 blinded safety data for all Stage 1 participants was reviewed and determined safe, the study proceeded to Stage 2, during which 143 participants aged 65 to 85 years were randomized.
725465|NCT02117544|Subjects were recruited from 7 study centers located in the US.|Of the 268 enrolled, 159 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (109).
725466|NCT02117479|Participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were randomized in the study.|Treatment was started as soon as possible after randomization (within 3 days) and consisted of continuous 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered for the entire cycle.
725467|NCT02117427||A total of 14 patients signed the Informed Consent Form and underwent the study screening procedures. Of these 14 patients, a total of 11 patients were enrolled into Study MG-EP-RF-02. These 11 patients are included in the ITT cohort. One patient (Group B) had an SAE prior to study procedures and became no longer eligible.
725468|NCT02117414|A total of 275 subjects were enrolled (consented) at 42 centers in the Evera MRI study. The first enrollment occurred on April 17, 2014, and the last enrollment occurred on September 11, 2014.|A successful implant was defined as having received a complete Evera MRI™ Study System (Evera MRI™ DR or VR ICD, one Model 6935M or 6947M lead, and one Model 5076 lead (if DR system)). Eleven subjects did not have an implant attempt and one subject did not have a successful implant. None of these subjects were randomized.
725469|NCT02117349|Of 87 planned participants, only 55 were randomized before the trial was terminated early due to device related (non-safety) issues|
725470|NCT02117310||
725471|NCT02117193||
725472|NCT02117050||The study was prematurely terminated due to enrollment issues. Only 1 subject was enrolled in this study, but did not receive any dose.
725473|NCT02117024||
725474|NCT02116972|Patients were screened for study eligibility at 48 study centers in the United States (US) and Canada. Enrollment took approximately 7 months.|Subjects were screened within 21 days of being randomized
725475|NCT02116803||
725476|NCT02116660|Human immunodeficiency virus (HIV) infected adults with stable suppressed HIV-1 ribonucleic acid (RNA) from at least 12 months prior to the screening visit, and with a current stable anti-retroviral (ARV) regimen were enrolled in this trial.|
725477|NCT02116621||
725478|NCT02116582|Male participants with progressive metastatic castration-resistant prostate cancer were enrolled in this study.|A total of 272 participants were screened for enrollment & signed an informed consent form, & 57 of those screen failed. The primary reason for screening failure was not fulfilling inclusion/exclusion criteria (52 participants, 19.1%), followed by withdrawal (5 participants, 1.8%).
725513|NCT02114177||A total of 310 participants were randomly allocated to the 2 treatment arms. All participants received at least 1 dose of study drug and were included in intent to treat (ITT) analysis set.
730085|NCT01787591||
742247|NCT01053507||
725479|NCT02116530|Four-hundred and one (401) participants were enrolled from 46 academic or community practice institutions in the United States between August 2014 and March 2015.|There were eighteen participants withdrew consent (8 Olanzapine; 10 Placebo); and three participants had major violations (2 Olanzapine; 1 Placebo). All of these 21 participants were excluded from all analyses.
725480|NCT02116361||
725481|NCT02116322|Patients were enrolled between 7/18/14 and 2/18/15 in an academic tertiary center|A total of 4 participants were enrolled. However, 3 participants were excluded before being assigned to the study arm because the performing endoscopist didn't find it possible to do the procedure due to the unfavorable size of the mass or technical difficulty.
725482|NCT02116309||We went above the goal sample size for enrollment as some of our centers had a few extra drug supplies available. Further, we allowed additional enrollment as it would strengthen data for our secondary objectives.
725483|NCT02116205|A total of 130 subjects were enrolled in the study. Ten of the 130 were enrolled as replacements for early withdrawals. The first participant was enrolled on July 9, 2014 and the last participant was enrolled in September 2015.|
725484|NCT02115984||
725485|NCT02115828|A total of 9 patients were enrolled on the study|
725486|NCT02115815|A total of 246 subjects were screened. Of these, 146 subjects were enrolled.|A total of 146 participants were enrolled in the study. Of the 146 randomized participants, 2 participants did not receive investigational product. 144 participants were included in the As-treated Population.
725487|NCT02115750||
725488|NCT02115646||
725489|NCT02115633|Thirty-one male community-dwelling veterans, ages 56-84, who experienced sensory peripheral neuropathy and balance problems, participated in the trial.|
725490|NCT02115607||
725491|NCT02115581|Patients younger than 18 years with known diagnosis of primary dilated cardiomyopathy referred for follow-up echocardiography to Children's Medical Center between September 2006 to March 2008 were recruited.|
725492|NCT02115542||
725493|NCT02115386||
725494|NCT02115373|First participant signed informed consent:18 May 2014, Last participant last visit: 14th Feb 2018|In Phase 1b, 24 participants were screened of which, 17 started the treatment. In Phase 2 ,155 participants were screened, of which 49 participants started the treatment.
725495|NCT02115347|Based on a statistical evaluation of the pharmacokinetic (PK) data obtained from participants with moderate hepatic impairment and matched healthy volunteers, and the pre-specified decision criteria, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|
725496|NCT02115321|The screening period lasted for 60 days. Recruitment was halted after enrolling participants in the two Part A arms, as the current clinical development plan is focused on a fixed-dose combination (FDC) product containing grazoprevir (GZR) 100 mg and elbasvir (EBR) 50 mg. No participants were enrolled in Parts B or C.|
725497|NCT02115308|All subjects were recruited from two groups: a population with coronary artery disease (CAD) of those with low-likelihood-CAD (Control). The myocardial segment perfusion and wall motion scores from the prior clinical positron-emission-tomography (PET) were used to classify segments as one of the following: CONTROL, CAD_REMOTE, CAD_REVERSIBLE.|"Cardiac Magnetic Resonance (CMR) imaging was performed in the same order for all subjects with rest imaging preceding regadenoson stress imaging.
~The same prescription for tagged CMR slice locations (basal, mid, and apical) were used at both rest and stress."
725498|NCT02115269||
725499|NCT02115256|6 Participants were enrolled from 06/12/2014 to 05/12/2015.|
725500|NCT02115113|68 participants completed run-in but only 50 decided to move forward to randomization.|This study included a run-in period and a randomization period. Run-in started 4 weeks post-transplant and ended at 5 months post randomization. After run-in, eligible participants were randomized in a 1:1 ratio to tacrolimus elimination or tacrolimus minimization.
725501|NCT02115048||For all patients consented on the trial, a tumor sample was sent to the central lab for testing of ER/PR and HER2 and determination of the H-score. This was assessed prior to randomization. Patients with HER2 negative, ER+ advanced breast cancer with low ER expression defined as H-score between 1 and 159 entered screening phase.
725502|NCT02114931|This study was conducted at 83 centers in 11 countries in Eastern Europe, North America and Western Europe.|Study 20130258 was a single-arm, open-label extension of the parent Study 20120262 (NCT01970475). Results are reported according to treatment in the parent Study 20120262.
725503|NCT02114892||
725504|NCT02114879|Participants were recruited from 2 skilled nursing facilities in the St. Louis, Missouri metropolitan area from July 29, 2014 through March 22, 2018.|
725505|NCT02114697||A total of 11 individuals gave informed consent to participate in the study, however, one withdrew from the study and one was lost to follow up before being assigned to a study arm. These individuals are not considered as enrolled as no clinical data were collected. Nine participants were assigned to a study arm and began the intervention.
725506|NCT02114684||One individual in the control arm was terminated one month after enrollment owing to discovery of pre-existing violation of entry criteria. The individual was excluded from all statistical analyses.
725507|NCT02114515||
725508|NCT02114385|A total of 502 participants were screened and 500 were randomized|
725509|NCT02114307|Recruitment from vascular outpatients clinic between 20/02/2014 - 18/09/2014.|Patient stayed in the full length of the study. Chronic venous insufficiency (C2-C5 CEAP). Blood pressure <160/100mmHg. No current foot ulceration
725510|NCT02114268||There were 342 participants who were screened. A total of 136 participants met eligibility criteria and were randomized into the study.
725511|NCT02114216|The subjects were enrolled prospectively at Seoul National University Bundang Hospital between March 2010 and August 2014. Those enrolled subjects visited SNUBH gastroenterology department mainly for evaluating the origin of suspicious GERD symptoms or for screening of gastric cancer.|Subjects were excluded if there was a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus).
725512|NCT02114203||Overall, a total of 30 potential participants were randomized to the study, and 29 of them were assigned to and received study treatment, 1 participant in the PF-04447943 25 mg twice daily (BID) treatment group withdrew from the study after randomization but prior to study treatment.
725514|NCT02114151||A total of 147 participants from the United States and Canada were Screened and 103 were enrolled into the study. All 103 participants who received at least 1 dose of study drug and so were included in intent to treat (ITT) population.
725515|NCT02113956|All participants were recruited through national advertisements on Facebook. Multiple ad images and text were used. To ensure a demographically representative sample, targeted ads were also used to enroll individuals from particular subgroups who are typically more difficult to engage in research|
725516|NCT02113579||
725517|NCT02113449|Adult subjects with nasal congestion were recruited at the study sites from their volunteer database and through advertising.|This was a 2-part study. In Part 1, recruited participants viewed a description of new treatment option (concept). Interested participants entered the trial. Eligible participants who consented received one dose of nasal CO2 in the clinic under medical supervision. Participants who wished to continue took the device home for 6 days (Part 2).
725518|NCT02113436|Study evaluated the efficacy and safety of fluticasone propionate (FP)/salmeterol xinafoate hydrofluoroalkane (SLM HFA) twice-daily (BID) via metered-dose inhaler (MDI) for 8 weeks in comparison with FP HFA in 6-months to 4-years-old Japanese participants (par.) with infantile bronchial asthma.|Eligible par. at screening entered a 2-week run-in period to receive FP HFA MDI 50 µg, followed by 8-week double-blind treatment period (TP) 1 to receive FP/SLM HFA MDI 50/25 µg or FP HFA MDI 50 µg. In TP2, par. received FP/SLM HFA MDI 50/25 µg for 16 weeks. The total duration of the study was 27 weeks with follow-up.
725519|NCT02113410|Participants were recruited from two settings-a senior housing facility and a senior day center-through an information session conducted at each site by the principal investigators and Project Directors. There were 3 cohorts (waves) in the study. In each cohort, recruitment was started 2 weeks prior to the each intervention.|
725520|NCT02113241||
725521|NCT02113189||
725522|NCT02113124||
725523|NCT02113007|In August 2015, 2 patients with confirmed primary central nervous system (CNS) lymphoma were enrolled in the trial. Only one (of 4) investigational sites in the U.S accrued patients. Due to slow enrollment, the study was terminated in February 2016.|
725524|NCT02112994|A total of 21 study centers were initiated in 15 countries, including Australia, Belgium, Brazil, Canada, Croatia, Denmark, Germany, Italy, Mexico, Netherlands, Russia, Spain, Turkey, United Kingdom (UK), and the United States. Seventeen study centers screened at least 1 participant in all of these countries, except the UK and the Netherlands.|All participants began treatment with sebelipase alfa at a dose of 1 milligram/kilogram (mg/kg) every other week (qow). Individual participants could escalate/decrease their dose at any time during the study and only at the discretion of the Investigator and in consultation with the Sponsor. All 5 different doses are presented as Milestones below.
725525|NCT02112877||A total of 200 subjects have been enrolled in the VIRTUS Trial, including 30 subjects in the feasibility cohort and 170 subjects in the pivotal cohort.
725526|NCT02112838||
725527|NCT02112526||
725528|NCT02112448|We enrolled 78, but 18 were excluded after informed consent for the reasons listed below. 30 in each group were assigned and completed the study.|
725529|NCT02112370||
725530|NCT02112045|The study opened to participant enrollment on 01/20/2015 and closed to participant enrollment on 07/03/2018.|
725531|NCT02111993||60 patients were consented and enrolled in this trial. 9 of which were withdrawn due to incomplete lab draws. 51 patients successfully completed study procedures and were included in the study data analysis.
725532|NCT02111980|Patients that required a pacemaker/ICD generator change or device implant were approached for participation in this study in both the Sulpizio Cardiovascular Center Clinic and Pre-procedural Unit. Patients undergoing PTE Surgery were also approached in these settings.|
725533|NCT02111863||
725534|NCT02111811||
725535|NCT02111785||
725536|NCT02111772||
725537|NCT02111746||
725538|NCT02111603|Participants were recruited from the Mayo Clinic in Rochester, Minnesota.|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities.
725539|NCT02111564|12024 participants were randomized (rivaroxaban-6007;placebo-6017). 5 participants in placebo were excluded(2 invalid consent,3 randomized before Health Authority approval).|Participants were randomized (1:1) to receive rivaroxaban or placebo. In rivaroxaban, participants were treated with rivaroxaban 10 mg or 7.5 mg as per their creatinine clearance level. Data in the participant flow section is reported for study discontinuation from the disposition data.
725540|NCT02111447||
725541|NCT02111369|Participants were recruited from the Emory Voice Center from August 2014 to February 2015.|Participants who previously received botulinum toxin injections for essential voice tremor (EVT) underwent a three month washout period prior to participation.
725542|NCT02111252|Participants took part in the study at 1 investigative site in Japan from 23 March 2014 to 15 April 2014.|Informed consent for the study was obtained from 64 subjects in total. All subjects who gave informed consent were screened for eligibility, and 55 of these subjects were enrolled.
725543|NCT02111213||
725544|NCT02111200||There was no washout period prior to enrollment. Individuals who were enrolled in the trial were not on any medications.
725545|NCT02111187||
725546|NCT02111174||1 participant was consented and enrolled for training purposes only with the scrambler machine. This participant was not randomized into an arm and was not used in analysis.
725547|NCT02111096||
725548|NCT02111083||
725549|NCT02110901|349 patients signed informed consent; 313 patients were randomized; 311 were treated|Participants were excluded from participation if they did not have a radiocephalic AVF created at the time of surgery.
725550|NCT02110706||68 study participants were consented and assessed for eligibility. 14 participants were ineligible. 2 participants declined. 52 study participants were randomized.
725551|NCT02110693||
725552|NCT02110485||
725553|NCT02110381|Medical records were screened for initial eligibility criteria between 9/2014 - 4/2015. Patients were then contacted via letter and phone to gauge interest.|After consent, participants completed a run-in period in which they measured their blood pressure at home for 2 weeks. Participants with multiple readings greater than 160mmHg SBP or 100mmHg DBP were considered screen failures (n=13, plus 1 withdrawal).
725557|NCT02110225||Fifty patients were enrolled in the study. Two additional patients provided valid, written, informed consent but were not randomized due to screening failure. No study medication was administered to these patients.
725558|NCT02110147||
725559|NCT02110095||
725560|NCT02109939||
725561|NCT02109809||
725562|NCT02109731||
725563|NCT02109640||62 patients consented to study participation but 12 were not assigned to the study. This was because consent was obtained a few weeks before the date of surgery and in that interval 12 patients became ineligible (change of planned operation, presentation as emergency, development of ineligibility criteria, withdrawn from anaesthetic protocol).
725564|NCT02109562||A total of 538 subjects were screened for study participation at 33 sites in the US, including 354 subjects randomly assigned to treatment. Four subjects were found to be randomized incorrectly; therefore, they were withdrawn from the study and did not receive study drug (counted as 'Physician Decision' for reason d/c below).
725565|NCT02109497|Participants were screened and enrolled at one study site in Australia|
725566|NCT02109484|Age de-escalation, dose-escalation study enrolling healthy toddlers and infants between 17 March and 29 September 2014 at a single site in South Africa.|
725567|NCT02109458||
725568|NCT02109445|The study planned to include 2 phases: Phase 1 (dose-finding phase) followed by Phase 2 (randomized phase). Due to early termination of the study, only 3 participants were enrolled in Phase 1 and Phase 2 was not conducted.|
725569|NCT02109432||
725570|NCT02109419||
725571|NCT02109172||
725572|NCT02109159||
725573|NCT02109133|Subjects were screened and enrolled at 1 site in the Korea|No test entered
725574|NCT02109107||
725575|NCT02109042||
725576|NCT02109029||
725577|NCT02108977||
725578|NCT02108964|This is a 2-part study conducted in 14 investigative sites in 9 countries: Phase I part (dose-escalation) and Phase II part (dose expansion)|370 subjects were screened for eligibility during the 28 days prior to starting study treatment on Cycle 1 Day 1 (C1D1). The eligibility assessments were performed and ensured that all inclusion and exclusion were satisfied
725579|NCT02108951||
725580|NCT02108912||
725581|NCT02108691||
725582|NCT02108652||The analysis included data up to cutoff date 04 July 2016.
725583|NCT02108457||
725584|NCT02108288||
725585|NCT02108223||
725586|NCT02108171|Patients of ASA physical status I or II, aged between 18 and 60 yrs, scheduled for elective suspension for remove of benign lesions under general anesthesia between September 2013 and April 2014|40 patients receive intranasal dexmedetomidine (1 µg.kg-1 in 1 ml) and 41 patients receive intranasal saline (1 ml) 45-60 min before anesthetic induction.
725587|NCT02107898|The study was conducted at 31 centers in Japan. A total of 319 participants were screened between March 2014 and July 2014, 103 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.|Randomization was stratified according to heterozygous familial hypercholesterolemia (heFH) population. Assignment to treatment arms was done using an Interactive Web Response System in 1:2 (Placebo: Alirocumab) ratio after confirmation of selection criteria. 216 participants were randomized.
725588|NCT02107859|Participants with nonsense mutation cystic fibrosis (nmCF) who had completed the double-blind study PTC124-GD-009-CF (NCT00803205) were enrolled and treated in this open-label extension study.|On 2 March 2017, it was announced that the Phase 3 double-blind study PTC124-GD-021-CF (NCT02139306) did not achieve its primary or secondary endpoints. Based on these results, clinical development of ataluren in cystic fibrosis was discontinued and this ongoing open-label extension study was closed.
725589|NCT02107703||In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
725590|NCT02107599||
725591|NCT02107482||
725592|NCT02107443||
725593|NCT02107339||
725594|NCT02107313|Participants were screened and enrolled at 1 site in Australia|
725595|NCT02107300||
725596|NCT02107274|A total of 90 subjects with a High Resolution CT scan diagnosis of pulmonary bronchiectasis was recruited from January - October 2011. Recruitment was done amongst patients in chest clinic, Hospital Taiping. A total of 78 subjects were selected based on the inclusion and exclusion criterias.|12 subjects were excluded from randomization as they did not have chronic sputum production and were unable to perform spirometry.
725597|NCT02107196|The first patient was screened on 27th February 2014 and the first patient randomized on 21st March 2014. The last patient completed the study on 22nd June 2015. The study was conducted at 158 clinical sites in 11 countries (Bulgaria, Czech Republic, France, Germany, Italy, Poland, Romania, Russia, Spain, the USA and the United Kingdom).|A total of 1237 patients entered a 2-week Screening period, 1034 entered the qualifying 2-week Run-in period and 535 of them were randomised. After completion of the double-blind 12-week treatment, 453 patients entered into the Randomised Withdrawal (RW) period.
725598|NCT02107131||
725599|NCT02107092|Participants took part in the study at 30 outpatient sites in the United States, Australia and South Africa from 10 May 2014 to 14 July 2015.|Participants that completed Study ZS-004 (NCT02088073) Extended Dosing (ED) Phase Study Day 29 Visit or discontinued Study ZS-004 during the ED Phase due to hypo- or hyperkalemia, had a mean i-STAT potassium value between 3.5 and 6.2 mmol/L, and were able to start dosing in Study ZS-004E within 2 days after the last dose of study drug in ZS-004.
725600|NCT02107014|Participants were recruited Feb-April 2014 from a laboratory database of individuals with fibromyalgia who are interested in participating in research.|
725601|NCT02106975||
725602|NCT02106962||
725603|NCT02106923||
725604|NCT02106910||
725605|NCT02106884|One hundred fourty-six patients (pt) were included. First pt enrolled: 08-May-2014. Last pt enrolled: 25-Nov-2015. End of trial notification: 15-May-2018 (last pt last visit) and submitted to ethics committee and competent authorities 10-Jul-2018. Last follow-up (FU) data collected 05-Feb-2019. Cut off date for final data was on 29-Apr-2019.|
730206|NCT01780935||
730207|NCT01780922||
730208|NCT01780870||
725606|NCT02106832|Study was conducted at 164 study centers in 25 countries between 30 April 2014 (first subject first visit) and 19 October 2016 (last subject last visit).|A total of 1123 subjects were screened and 521 subjects were randomized. The randomized subjects were allocated to treatment groups, and 2 subjects in the Cipro 14 group did not receive study medication.
725607|NCT02106728|Consecutive patients with Anorexia Nervosa admitted to the Eating Disorder Program between 2011 and 2014, were approached to participate within the first 3 weeks of treatment. Patients shared information about the study with their family members whom they identified as being involved in supporting them.Exclusion factors was current family violence.|Participants were assigned non-randomly to Separated Family Therapy (treatment as usual) or Multi-Family thearpy dependent on treatment availability. MFT was offered four times a year as a closed group. A series of groups would begin once four to six families consented to participate in the study. After a group started, families were offered SFT.
725608|NCT02106494||Patients receiving highly emetogenic chemotherapy were stratified by cisplatin and randomized 1:1 to one of two treatment arms
725609|NCT02106455|Participants took part in the study at 92 investigative sites in Japan, from 01 August 2008 to 24 October 2017.|Participants with a historical diagnosis of osseous Paget's disease were enrolled. Participants received interventions as part of routine medical care.
725610|NCT02106442|Participants took part in the survey at 148 investigative sites in Japan, from 13 May 2013 to 30 April 2018.|Participants with a historical diagnosis of osteoporosis were enrolled. Participants received interventions as part of routine medical care.
725611|NCT02106403|Partcipants were recruited at one clinical study site in China.|A total of 50 participants with 1:1 ratio of male to female were screened and 50 were randomized.
725612|NCT02106390|750 healthy infants, aged 3 months were recruited from 3 sites in Argentina and 4 sites in Mexico.|All enrolled subjects were included in the study.
725613|NCT02106351|Male and female subjects aged between 2 and 17 years with upper limb spasticity due to cerebral palsy (CP) were recruited from April 2014 and the study completed in September 2018. Subjects could receive a maximum of 4 treatment cycles (TC) over a minimum of 1 year and maximum of 1 year and 9 months, with at least 16 weeks between each TC.|Subjects had a body weight ≥10 kilograms (kg), increased muscle tone/spasticity in at least 1 upper limb, a modified Ashworth scale (MAS) score ≥2 in the upper limb primary targeted muscle group (PTMG) of the study limb at baseline. Subjects were stratified according to age (2-9 and 10-17 years) and Botulinum Toxin (BTX) naïve or non-naïve status.
725614|NCT02106325||
725615|NCT02106156||Per protocol participants were not allocated to study arms. Separation of participants was performed post hoc for all analyses. Participants who underwent elastography were allocated to separate arms as another time schedule was used and also untreated participants were documented, who were analyzed separately from treated participants.
725616|NCT02105987||841 participants (par.) were screened and 555 human immunodeficiency virus type 1 (HIV-1) infected par. who were on stable suppressive combination antiretroviral therapy (cART) with 2 nucleoside reverse transcriptase inhibitor (NRTIs) plus either a protease inhibitor (PI), an non-NRTI (NNRTI), or an integrase inhibitor (INI) were randomized.
725617|NCT02105974|Par meeting continuation criteria during the run-in period were randomized (1:1) to receive fluticasone furoate (FF)/vilanterol (VI) or VI. Of the 2423 par screened, 1622 were randomized. 1620 received at least one dose of double-blind study medication and comprised the Intent-to-Treat population.|Participants(par) with a history of chronic obstructive pulmonary disease(COPD) meeting eligibility criteria at screening were enrolled in a 2-week, single-blind(placebo) run-in period to obtain baseline use of albuterol(salbutamol), COPD symptom scores and disease stability.
725618|NCT02105961|Participants with chronic obstructive pulmonary disease (COPD) with frequent exacerbations, on high dose inhaled corticosteroid (ICS)-based triple inhaled maintenance therapy were included. Participants were randomized to receive mepolizumab (100 or 300 milligrams [mg]) or placebo by subcutaneous (SC) injection every 4 weeks for up to 52 weeks.|A total of 674 participants were randomized and received at least one dose of study treatment and were included in the modified intent to treat (mITT) population. One participant randomized to the mepolizumab 300 mg group was withdrawn without receiving study treatment.
725619|NCT02105948|Participants with chronic obstructive pulmonary disease (COPD) with frequent exacerbations and on high dose inhaled corticosteroid (ICS)-based triple inhaled maintenance therapy were included in this study. Participants were randomized to receive mepolizumab 100 milligrams (mg) or placebo by subcutaneous (SC) injection every 4 weeks for 52 weeks.|A total of 836 participants were randomized and received at least one dose of study treatment and were included in the modified intent to treat (mITT) population. One participant randomized to the placebo group was withdrawn without receiving study treatment.
725620|NCT02105740|The recruitment process was conducted from March to December 2015. Thirty nine patients were invited. They had cancer of digestive tract from both genders, of 40-70 years, with pain scores ≥ 3 by (EVA). Were excluded: patients that used psychotropic drugs, with psychiatric disorders, terminally ill cancer, hearing impaired and mentally disabled.|Were excluded: 3 patients weren't suggestible, 3 patients who had terminal cancer, 2 patients who reported low scores, and 7 patients for other reasons such as religious issues or not accepting the technique. One patient dropped out the treatment because he had limited mobility to return to the hospital.
725621|NCT02105701||
725622|NCT02105688||301 participants were randomized to either the Immediate Treatment Arm or to the Deferred Treatment Arm during Part A. 199 participants who completed Part A were enrolled in Part B; of these, 142 participants completed the study.
725623|NCT02105662||218 participants were enrolled and treated on study, 212 participants completed 24 weeks of follow-up.
725624|NCT02105636|506 enrolled, 361 randomized. Non-randomized reasons: 5 adverse events, 18 withdrew consent, 7 died, 108 no longer met study criteria, 7 other. 347 treated (236 nivo, 111 IC). Non-treatment reasons: 1 disease progression, 3 request to discontinue treatment, 6 withdrew consent, 4 no longer met study criteria. Nivo=nivolumab, IC=investigator's choice|
725625|NCT02105558||46 were enrolled, but only 43 started. Of the 3 who did not start: 1 gave birth before the block placement; 2 were disenrolled, but the reason was not recorded.
725706|NCT02099708|Participants took part in the study at 501 investigative sites in Japan from October 2010 to March 2014 (N=3,502).|Patients with a history of gastric or duodenal ulcers and requiring long-term use of nonsteroidal anti-inflammatory drugs were enrolled in the study.
742698|NCT01025284||This is a nonrandomized, open-label, 2-part study.
725626|NCT02105467|For Subject Disposition, Period 1 covers Day 1 through Week 12 for both treatment groups. Period 2 covers Week 12 through Week 36 for the Immediate Treatment Group (ITG) and Week 12 through Week 28 for the Deferred Treatment Group (DTG). Period 3 covers Week 28 through Week 52 for the DTG; the ITG completed the study with Period 2.|A total of 469 participants were screened and 421 were randomized.
725627|NCT02105454||Following 12 weeks of treatment with grazoprevir (GZR), elbasvir (EBR) and ribavirin (RBV), participants were followed-up for an additional 24 weeks.
725628|NCT02105415||
725629|NCT02105324||
725630|NCT02105285||
725631|NCT02105272||
725632|NCT02105246||
725633|NCT02105116|Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 02/17/2014 and was closed to accrual on 08/25/2015. The study was terminated on 12/16/2015.|We are reporting results on 6 eligible patients. One patient was deemed ineligible.
725634|NCT02105012|Conducted at 44 sites in the US from May 2015 to September 2015. Study participation maximum of 32 weeks.|A Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Four Doses of Budesonide Inhalation Aerosol (BD MDI, PT008) Relative to Placebo MDI in Adult Subjects With Mild to Moderate Persistent Asthma
725635|NCT02104947||
725636|NCT02104895||
725637|NCT02104830||7 patients were withdrawn for various reasons without receiving any dose of any of the studied products.
725638|NCT02104804|This study was performed at 22 sites in the People's Republic of China (PRC).The first patient was enrolled on 07 May 2014 and the last patient completed the study on 26 February 2016. The study was divided into a single-blind placebo lead-in period of 8 weeks, a treatment period of 24 weeks and a follow-up phase of 4 weeks.|953 patients were enrolled, of which 641 patients took at least 1 dose of study drug and entered the lead-in period. A total of 312 patients did not enter the lead-in period (289 did not fulfill eligibility criteria, 21 due to subject decision, 1 each for severe non-compliance to protocol and other reasons) and 466 patients were randomized.
725639|NCT02104765||
725640|NCT02104752||
725641|NCT02104739||21 subjects were enrolled. 20 were randomized, and these 20 participated in each of three arms (the exenatide, saxagliptin, and placebo arms), with the order of receipt being randomized. There was an extension phase (that is, the exenatide extended-release (ER) arm) in which 8 of the 21 enrolled participated.
725642|NCT02104583|Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 12 September 2014. The last study visit occurred on 14 October 2016.|389 participants were screened.
725643|NCT02104505||There was no wash out or run-in phase prior to treatment assignment. No enrolled participants were excluded prior to treatment assignment.
725644|NCT02104427||
725645|NCT02104414||
725646|NCT02104219|Patients were enrolled between March 2014 and September 2014. Fifty-four patients were screened and 32 patients were enrolled at 15 centers across the United States, Canada, Australia, Turkey, The Netherlands, and the United Kingdom.|
725647|NCT02104180||
725648|NCT02104167||
725649|NCT02104141||
725650|NCT02103855|"First patient enrolled and started on June 3, 2014. Last patient enrolled and started on Aug 6, 2014.
~All patients enrolled at Indiana University Hospital - Transplant Unit."|Participants were enrolled according to inclusion and exclusion criteria. Tacrolimus was weaned according to protocol.
725651|NCT02103816||One additional patient was enrolled beyond the limitations specified by the original protocol. The protocol was amended (and approved by the IRB) part way through the study to allow for the enrollment of this additional subject.
725652|NCT02103608||
725653|NCT02103478|In Phase 1, 127 participants were screened and 44 were randomized and received at least one treatment. In Phase 2, a total of 138 were screened, 86 were randomized, and 80 received at least one treatment.|Response data for Phase 1 per June 2017 data cut and for Phase 2 per June 2018 data cut. Median follow up in Phase 1 was 1915.5 days (range: 1771-2213) and 1563.0 days in Phase 2 (range: 1199-1710).
725654|NCT02103439||
725655|NCT02103309|Participants were recruited from 5 study centers located in Japan.|This reporting group includes all enrolled participants.
725656|NCT02103270|All arms undergo an Initial Dose Escalation (IDE) Day and updosing regimen with a maintenance phase of OIT or placebo to a maximum of 4,000 mg protein daily, as peanut flour, in the OIT groups, and to a maximum of an equivalent amount of oat flour for the placebo group.|At Week 104, individuals that reach criteria will, based on the randomization, either stop therapy with peanut and be switched to oat flour or will maintain on 300 mg peanut protein per day and all placebo subjects decreased to the equivalent volume of oat flour to optimize the blind. All subjects were evaluated every 13 weeks with DBPCFCs.
725657|NCT02103218||
725658|NCT02103127||
725659|NCT02103114|Five subjects enrolled but withdrew prior to randomization|
725660|NCT02103062|Participants must have been previously treated and must have had radiologically documented measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and disease progression ≤ 2 months after the last delivery of the last standard therapy. They were enrolled by family of oncogenic proteins (RAS) mutation status .|An efficacy analysis was conducted based on the data available for those accrued in each of the cohorts enrolled (Stage 1) between May-September 2014. The data from the primary efficacy endpoint met the stopping criteria defined by the Simon 2-stage design, which did not support further assessment of nab-paclitaxel; the study was stopped early.
725661|NCT02102932|The study was performed as an open-label, randomised, single-dose, two-way crossover trial consisting of four trial parts. In each trial part the aim was to investigate the relative bioavailability of the Test treatment (T) and to compare it with the Reference treatment (R).|
725662|NCT02102724||
725663|NCT02102490||In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
725664|NCT02102464||
725665|NCT02102399|The population sample was selected by convenience criteria. All the school's teachers were invited to participate and were selected according to eligibility criteria in the beginning of the study.|
725666|NCT02102230||
725667|NCT02102204|The study was conducted at 229 study centers in Europe, Australia, New Zealand, and North America|A total of 902 participants were enrolled in Study 20130213: 215 and 200 participants from the cinacalcet and etelcalcetide groups of the double-blind parent Study 20120360 (NCT01896232), respectively, and 487 participants from the open-label parent Studies 20120231 (NCT01785875) and 20120334 (NCT01576146).
725668|NCT02102100|Male and female smokers between the ages of 18 and 30 yrs, with a history of smoking for the past 12 months, at least one cigarette per day.|
725669|NCT02101983||
725670|NCT02101918||
725671|NCT02101788|A total of 260 patients enrolled before accrual closed on 04/10/2018.|
725672|NCT02101554||
725673|NCT02101515||
725674|NCT02101437||
725675|NCT02101411||
725676|NCT02101359|The patients, fulfilling the criteria for inclusion were invited to participate in the study.|
725677|NCT02101294||
725678|NCT02101281||The investigator included in the study 40 subjects. After inclusion, all the 40 subjects took the study treatment. In detail, the first 20 enrolled subjects received rhNGF 20 μg/mL eye drops (Group 1) and the last 20 enrolled subjects received rhNGF 4 μg/mL eye drops (Group 2).
725679|NCT02101190||
725680|NCT02101112||69 participants enrolled, 33 participants randomized. 36 participants were enrolled but not randomized. Reasons for non-randomization include 30 participants no longer met study criteria, 4 participants withdrew consent, 2 participants were not needed for the study.
725681|NCT02101021|Participants were enrolled at study sites in the United States (US). The first participant was screened on 02 June 2014. The last study visit occurred on 10 April 2017.|"38 participants were screened.
~Data submitted represent analysis performed on data collected in the lead-in phase by the Study Termination Date, 10 April 2017. The study was discontinued before initiation of the randomized treatment phase, therefore no data were collected for the randomized treatment phase."
725682|NCT02101008||
725683|NCT02100969|North American study involving 5 sites (4 in the US and 1 in Canada). Subjects were recruited through clinical practice and advertisement through the Myasthenia Gravis Foundation of America.|
725684|NCT02100930||
725685|NCT02100839|Study conducted at Linear Clinical Research Ltd, a medical clinic in Nedlands WA Australia.|
725686|NCT02100826||
725687|NCT02100813|Participants were recruited in 7 centres in the US into Part 1 of the trial. First participant was enrolled on 14-05-14 and the last subject´s last visit (LSLV) was on 12-08-14. Participants were recruited in 11 centres in the US and 5 centres in Germany into Part 2 of trial. First participant was enrolled on 03-09-14 and LSLV was on 02-03-14.|
725688|NCT02100748||
725689|NCT02100670|Participants were recruited at 16 centers in Germany.|A total of 388 participants were screened, out of which 385 were randomized, 3 did not meet the study criteria. Of the 385 participants randomized, 360 participants completed the study, 25 did not complete the study.
725690|NCT02100657|39 patients were enrolled at 7 sites in Spain and France and 36 of them were treated with the combination of plitidepsin, bortezomib (BTZ) and dexamethasone (DXM). Patients who participated between 18Jun2014-30Aug2018 (cutoff date). The first dose of the first cycle was administered on 7Jul2014 and the last cycle was administered on 25May2018|Age≥18;Consent Informed (CI) signed;Confirmed diagnosis of MM according to the Durie-Salmon criteria;Relapsed and/or refractory disease;Eastern Cooperative Oncology Group performance status (ECOG PS)≤2
725691|NCT02100644|Participants (par.) receiving monotherapy treatment with sodium valproate (VPA) maintenance dose of 400-1200 milligrams/day [mg/d]) due to a history of partial seizures (including secondary generalized seizures) or tonic-clonic seizures, and whose seizures had been controlled for 12 weeks (wk) prior to start of treatment were enrolled in the study.|A total of 33 participants were enrolled into the study and 20 participants completed the study.
725692|NCT02100579||
725693|NCT02100514||This study was conducted at multiple sites from 28 October 2014 to 15 July 2016 for the treatment period and up to 10 July 2017 for the extension period.
725694|NCT02100475|The trial was conducted at 19 sites in 8 countries as follows: Argentina: 2 sites; Greece: 2 sites, Hungary: 1 site; Russian Federation: 5 sites; Slovakia: 4 sites, South Africa: 1 site; Spain: 1 site, United States: 3 sites.|Subjects with type 2 diabetes mellitus who were inadequately controlled (HbA1c level ≥ 7% [53 mmol/mol]) on treatment with IDegLira and metformin after 26 weeks of treatment in the NN9068-3952 trial were screened. Eligible subjects were randomised in a 1:1 manner to one of the two parallel treatment groups (IDegLira or IDegLira + IAsp).
725695|NCT02100410|Participants were recruited from 1 study center located in the US.|Of the 50 enrolled, 1 participant was exited as a screen failure prior to randomization and exposure to the study product. This reporting group includes all randomized participants (49).
725696|NCT02100319|Participants took part in the study at 146 investigative sites in Japan, from 03 March 2014 to 29 February 2016.|Participants with a historical diagnosis of both hypertension and type 2 diabetes mellitus were enrolled. Participants received interventions as part of routine medical care.
725697|NCT02100280||
725698|NCT02100228||
725699|NCT02100189||
725700|NCT02100124||
725701|NCT02100072||
725702|NCT02100007|This study was open to recruitment from April 30, 2014 through December 7, 2015 at 7 investigational sites in the USA and 2 sites in the United Kingdom. Forty-six patients were enrolled. The study was conducted in two parts. Fourteen (14) patients enrolled in Part 1 and 32 subjects were enrolled in Part 2.|Fifty-eight (58) potential participants were screened; 46 subjects passed screening and were enrolled in the study.
725703|NCT02099838|98 participants were recruited at 15 hospitals in Wuhan between March 2012 and September 2013.|All participants were randomized to the two groups.They had a week for washout before the trial, during which they received diet and sport instructions, kept the sulfonylureas (SUs) unchanged and didn't use any drugs affecting blood glucose.
725704|NCT02099786|Forty-seven Veterans receiving cisplatin for the treatment of cancer were randomized to one of the two treatment arms of the clinical trial. Thirty-six healthy participants were studied to assess normal variability in auditory function measures over time; they were not part of the clinical trial portion of this research project.|
725705|NCT02099721||
725833|NCT02091362||
744913|NCT00910988||
725707|NCT02099682|Participants took part in the study at 460 investigative sites in Japan from August 2010 to January 2014 (N=3366).|Patients with a history of gastric or duodenal ulcers and requiring long-term use of low-dose aspirin were enrolled in the study.
725708|NCT02099461||On study day 1, eligible participants were randomized into 1 of 3 treatment assignments. Randomization was stratified by average length of menstrual cycle (< 28 days, equal to 28 days, and > 28 days).
725709|NCT02099344||
725710|NCT02099318||
725711|NCT02099266||
725712|NCT02099110|The trial was conducted in 21 countries and included 242 trial centers.|Participants on ≥1500 mg/day of metformin for ≥8 weeks with A1C ≥7.5 and ≤11% at screening could directly enter a 2-week, single-blind, placebo run-in period. Participants who did not meet these criteria, received diet/exercise counseling and metformin titration (as necessary) for ~8 weeks before entering the 2-week, placebo run-in period.
725713|NCT02099084|Subjects were recruited from the Mayo Clinic Home Parenteral Nutrition program in Rochester, Minnesota.|
725714|NCT02099006||
725715|NCT02098993||
725716|NCT02098746|This observational study took part at 64 investigative sites in Japan from 15 June 2011 to 31 July 2014.|Participants with a diagnosis of type 2 diabetes mellitus receiving treatment with pioglitazone/glimepiride 15 mg/1 mg once daily in routine clinical practice, because pioglitazone alone was not considered effective, were enrolled in the study.
725717|NCT02098733|Participants took part in the study at 182 investigative sites in Japan from 15 June 2011 to 31 May 2014.|Participants with a historical diagnosis of type 2 diabetes mellitus for whom therapy with pioglitazone combined with glimepiride is suitable and long-term treatment is considered necessary were enrolled in one treatment group to receive pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
725718|NCT02098395|Subjects were randomised at 113 sites in 13 countries: Austria 2 sites, Belgium 9 sites, Bulgaria 5 sites, Canada 9 sites, Denmark 4 sites, Finland 6 sites, France 9 sites, Italy 7 sites, Netherlands 5 sites, South Africa 2 sites, Spain 5 sites, Sweden 5 sites, United States 45 sites.|
725719|NCT02098369||
725720|NCT02098304|A total of 42 Patients were recruited to the study from three UK General Dental Practices by four investigators. All 42 patients attended both Visit 1 and 2 and completed the study. There were no patient withdrawals. Patients were recruited at the three sites over an 8 month period from May 2014 to January 2015.|
725721|NCT02098109|The study opened to participant enrollment on 08/20/2014 and closed to participant enrollment on 06/14/2016.|
725722|NCT02097992||
725723|NCT02097849||
725724|NCT02097823||
725725|NCT02097745||
725726|NCT02097732||
725727|NCT02097719||
725728|NCT02097641|From March 24, 2014, to Feb 9, 2017, 1038 patients were screened for eligibility, of whom 975 were excluded, and 63 were randomly assigned to a treatment group. Three patients were not eligible for treatment after randomization and, therefore, 40 patients received human mesenchymal stem cells and 20 patients received placebo.|Three patients who were randomly assigned to receive human mesenchymal stem cells, were excluded: 2 did not meet baseline stability criteria; 1 patient's PaO2:FiO2 > 200 mmHg.
725729|NCT02097537||
725730|NCT02097472|"Recruitment period: approximately 12 months
~Site: Single center at Kenya Medical Research Institute/Walter Reed Project (KEMRI/WRP) Kombewa Clinical Research Center (CRC)"|
725731|NCT02097420|A total of 20 subjects were enrolled across 14 investigational sites through March 3, 2017. The first subject was enrolled in the trial on May 7, 2015. All the subjects underwent implantation with SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve (15mm HP valve).|Of the 20 enrolled subjects, 7 were terminated from the study.
725732|NCT02097303||
725733|NCT02097290||
725734|NCT02097277||"219 participants were enrolled; 138 entered the lead-in period. Reasons for not entering lead-in period included not meeting study eligibility criteria. 120 were randomized to treatment. Reasons not randomized: 6 withdrew consent, 2 lost to follow-up, 4 no longer met study criteria, 1 due to admin.reason by Sponsor and 4 due to other reasons."
725735|NCT02097238||
725736|NCT02097134||
725737|NCT02097108|11 patients were enrolled at 3 sites in Austria. First patient in was 15.05.2014; last patient in was 23.06.2015.|
725738|NCT02097056||Out of the 171 participants enrolled into the study, 1 was not treated resulting in 170 participants in the safety population.
725739|NCT02097030|Single center evaluation. Thirty five subjects were recruited and 30 subjects completed the trial.|Three participants were enrolled in the study but did not meet inclusion criteria, therefore discontinued before lens randomization.
725740|NCT02096952||
725741|NCT02096900||
725742|NCT02096861||
725743|NCT02096835|Patients were recruited from Jan 2014 to Dec 2014 in North Institute of Huashan Hospital,Fudan University,Shanghai,China|243 patients were assessed for eligibility, 86 were excluded for reasons below: Refused to participate. (n=12) Did not meet inclusion criteria. (n=71) Insufficient time to prepare for the study. (n=3)
725744|NCT02096744|This study was conducted in three separate groups.|
725745|NCT02096731|The base cohort included 115,397 new users of tiotropium or a LABA (+/- ICS) between 01Jan2002 & 31Aug2013.These patients included 26,442 new users of tiotropium & 88,955 new users of LABA.Patients initiating treatment with both bronchodilators on the same date were excluded.|"Patients receiving combination therapy were those who either added tiotropium to LABA, or added LABA to tiotropium.
~In the Participant Flow & Baseline Characteristics modules, no participants were represented in both the Tiotropium & the LABA Arms/Groups."
725746|NCT02096718|30 patients were entered, treated and analyzed.|This was a non-randomised, non-controlled, open-label, single-dose trial with matched group design. Group 1 contained subjects with moderate renal impairment, Group 2 subjects with severe renal impairment, and Group 3 subjects with normal renal function; groups were dosed sequentially.
725747|NCT02096705||477 participants were enrolled; 313 entered lead-in period; 272 participants were randomized to a treatment group. Of the 205 participants not randomized to a treatment group: 190 No longer met study criteria, 11 withdrew consent, 2 were lost to follow-up, and 2 were removed for administrative reasons.
725748|NCT02096692||
725986|NCT02079519||
725987|NCT02079311||
725749|NCT02096679|8 subjects were recruited into the study, as anticipated in the protocol. All received treatment with 20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1 and all completed the study.|8 evaluable patients were planned to be enrolled. These 8 evaluable patients were assigned to take 20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
725750|NCT02096588|27 -Hopkins 7 - Sibley memorial (DC)|3 subjects were screen failures, therefore 31 subjects were assigned to a treatment group in study
725751|NCT02096575||
725752|NCT02096471||The study required at least 1 partial or complete response within the first 9 patients in order to complete recruitment.
725753|NCT02096458|A total of 8 participants were screened for the study, and all participants subsequently enrolled.|
725754|NCT02096276||Total of 1517 pregnancy reports (1455 prospective and 62 retrospective) were collected in the Boostrix US Pregnancy Registry. Of the 1455 prospective reports, 250 had known pregnancy outcomes, 1188 were lost to follow-up and 17 pregnancies were ongoing. Of the 62 retrospective reports, 55 had known pregnancy outcomes and 7 were lost to follow-up.
725755|NCT02096263|This study was conducted in 43 centers in the United States of America (USA).|
725756|NCT02096107||
725757|NCT02096081||
725758|NCT02096042|Recruitment Period: April 24, 2014 to July 08, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|Study was terminated early due to low enrollment.
725759|NCT02096029||"Of 1,278 Enrolled:
~32 Individuals later found to be ineligible
~1 person missing contact info
~1,245 = Final Intent to Treat Sample"
725760|NCT02096003|Recruitment began in April 2014 with enrollment from May 2014 to May 2017|
725761|NCT02095951|135 episodes screened, but only 36 initially met enrollment criteria. 27 unique patients were enrolled for 33 episodes (6 patients enrolled twice) of possible catheter infection.|3 enrolled participants were removed from the study/analysis for failure to meet final enrollment criteria. Patient participants could be re-enrolled in the study more than once if their infection episodes (cases) were separated by at least 28 days.
725762|NCT02095873||
725763|NCT02095691|The study enrollment took approximately 3 months, began on October 21, 2013 and completed on December 17, 2013. A total of 37 subjects were consented and 19 underwent treatment with the study catheter in 4 investigation sites in New Zealand, Czech Republic, and Italy.|
725764|NCT02095561||
725765|NCT02095535||
725766|NCT02095340||
725767|NCT02095223||
725768|NCT02095197||
725769|NCT02095158||
725770|NCT02095145||38 participants consented, only 30 eligible to start study
725771|NCT02095106||
725772|NCT02094937|A total of 551 participants were screened, 490 entered into the run-in period, 430 entered into the open label treatment period 1(Period 1) and 371 were further randomized to treatment Period 2 (Period 2). Note that 1 subject was randomized incorrectly even though the subject failed at randomization.|Eligible participants entered a 4 week run-in period followed by an 8 week open label treatment period. Participants whose asthma was well controlled at visit 5 (end of Period 1) were randomized in a 1:1:1 ratio to a double blind study period of 12 weeks. They were informed to avoid Salbutamol inhaler within 6 hours at each visit.
725773|NCT02094898|Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between 12/30/14 and 5/18/16.|
725774|NCT02094885||
725775|NCT02094872|Based on the initial 23 patients enrolled on this study who underwent molecular profiling and tumor board evaluation, 20 were assigned MEK162 by the tumor board. Patients not assigned MEK162 still received their assigned treatment, but were not considered evaluable for the primary endpoint.|
725776|NCT02094755||
725777|NCT02094677|Seventy four participants were enrolled into the study and 70 participants were randomized and completed the study. 40 were habitual wearers of etafilcon A lens and 30 were habitual wearers of nelfilcon A lens.|
725778|NCT02094664||
725779|NCT02094612||
725780|NCT02094573|Participants took part in the study at 94 investigative sites in the United States, Canada, Europe, Australia and Asia from 04 Jun 2014 up to clinical cut-off date 29 Feb 2016. Study is ongoing.|Participants with ALK-positive, locally advanced or metastatic NSCLC who were treated with crizotinib were enrolled to receive brigatinib 90 mg, once daily or brigatinib 90-180 mg, once daily.
725781|NCT02094534|All subjects took all doses of intervention.|Basal Exogenous Insulin - Intend to Treat (ITT) - All Subjects
725782|NCT02094443||
725783|NCT02094352||
725784|NCT02094326||
725785|NCT02094300||
725786|NCT02094261|First patient enrolled: 28 April 2014, Data cut off: 1 May 2015. The study was open for enrolment at 44 study centres in Canada (3), Hong Kong (2), Italy (5), Japan (14), South Korea (3), Spain (6), Taiwan (2), and the USA (9). Recruitment has closed and primary analyses have been performed but study is still on-going.|472 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 262 patients were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 210 patients received treatment.
725787|NCT02093962||
725788|NCT02093949||
725789|NCT02093923|For this study, patients were recruited in United States, Italy, and Jordan between May 2014 and May 2015.|A total of 38 subjects were enrolled but one subject was a screen failure after randomization and only 37 subjects were treated and analyzed for safety.
725790|NCT02093897|This multicenter, multinational study enrolled subjects at 37 participating study centers in Australia, Europe, Georgia, Lebanon, Malaysia, Philippines, Switzerland, Thailand, Turkey, Ukraine, and the United States.|Screening took place 4 to 28 days prior to first dose of study product (rVIII-SingleChain). A total of 88 subjects were screened, 4 of these did not fulfill all eligibility criteria and were therefore screening failures.
725791|NCT02093819|The study was conducted in eight groups.|
725792|NCT02093793||After subjects were enrolled, they were evaluated per study eligibility criteria. Only those who met all criteria proceeded to receive implant and randomized in the study (as applicable).
725793|NCT02093702||
725794|NCT02093689||Part 2 of the study was not performed.
725795|NCT02093663|The study was conducted at 50 study centers and 33 sites consented at least 1 participant between 12 December 2014 (first participant first visit) and 28 November 2018 (last participant last visit).|Study was conducted in three phases as double blind acute (DBA), open label acute (OLA), and double blind maintenance (DBM) phase. Overall, 107 participants were enrolled and entered into DBA or DBM directly and eligible participants entered into DBM phase after DBA or OLA through DBA. Total, 105 participants received treatment and 65 completed.
725796|NCT02093520||
725797|NCT02093390|Participants took part in the study at one investigative site in the United States from 13 March 2014 to 19 April 2014|Healthy participants were enrolled equally in 1 of 2 treatment groups: TAK-385 + fluconazole or TAK-385 + atorvastatin.
725798|NCT02093351|First patient enrolled: 01 Sep 2014; last completed Part A: 28 Apr 2015. Last patient completed Part B: 27 Apr 2016. Part A assessed olaparib's effect on the pharmacokinetic (PK) parameters of anastrozole, letrozole and tamoxifen and vice versa; in Part B eligible patients received olaparib providing further safety data. Target accrual was met.|79 patients were assigned to study treatment and received at least 1 dose of olaparib in Part A; 18 patients did not fulfil eligibility criteria. Part A of the study consisted of 3 treatment periods preceded by a screening period. There was a 4-day washout between the first two treatment periods.
725799|NCT02093234|Participants were recruited from 3 medical clinic sites in Washington DC. Each site had its' own Principal Investigator ,research coordinator and community health worker. Recruitment started April 2014 and ended July 2015. The study period for each participant was 1 year.|
725800|NCT02093221||
725801|NCT02093026|This study included participants who had previously participated in studies WA16291 (NCT02693210) or WA17043 (NCT00074438).|
725802|NCT02092961|198 patients were enrolled: 34, 33 and 30 were randomised to Groups A, D and E (33, 28 and 29 received at least 1 dose of IP). Two of the randomised patients were in the main study (D4300C00004).|A total of 101 patients failed screening.
725803|NCT02092909|Patients were enrolled from 02 April 2014 through 31 March 2017 at 14 study sites in the United States.|Screening occurred ≤ 21 days before Day 1 (the first injection of study drug).
725804|NCT02092857||
725805|NCT02092662||
725806|NCT02092649|Recruitment period: May 2014 - Dec 2014 Location: University of Guelph|
725807|NCT02092610||
725808|NCT02092441||
725809|NCT02092415||
725810|NCT02092389||
725811|NCT02092350|This multi-site study enrolled adult, male and female participants with hepatitis C virus (HCV) genotype (GT) 1 with chronic kidney disease (CKD).|The screening period lasted for up to 60 days.
725812|NCT02092324|The first patient was enrolled July 8, 2014 and recruitment ended in September 2019, across seven medical centers in the US.|Two subjects who were enrolled were shortly determined to be misdiagnosed and were not evaluable bringing the total eligible subjects to 49. An additional subject was not evaluable for the primary endpoint because of missing bone marrow (BM) biopsy data.
725813|NCT02092311||
725814|NCT02092285||A total of 225 participants were screened; 205 participants started treatment after meeting eligibility criteria.
725815|NCT02092220||48 participants were enrolled in the trial, but only 43 participants actually participated. 2 participants were not eligible and 3 participants were not randomized because target enrollment was already met.
725816|NCT02092168||
725817|NCT02092116|"First subject screened 6 March 2014 and last subject last visit 25 June 2014 for Part A.
~First subject screened 19 May 2014 and last subject last visit 29 May 2015 for Part B.
~One clinical trial site at Aarhus University Hospital, Denmark"|7 patients were screened and 6 patients were enrolled in Part A. 24 patients were screened and 20 patients were enrolled in Part B.
725818|NCT02092025|Participants took part in the study at 738 investigative sites in Japan, from 20 June 2012 to 15 January 2016.|Participants with a historical diagnosis of hypertension were enrolled to receive Azilsartan 20 milligram (mg) - 40 mg tablet, orally, once daily for up to 12 months.
725819|NCT02091986||The enrollment number in the protocol section denotes the number of patients screened into the trial. Out of these 882 patients screened, 279 patients were randomized into the trial. This explains the discrepancy in patient number.
725820|NCT02091960|The study was conducted at 35 clinical sites in Belgium, Canada, Italy, Spain, the United Kingdom and the United States.|"This study enrolled women with human epidermal growth factor receptor 2 positive (HER2+) and androgen receptor positive (AR+) metastatic or locally advanced breast cancer who progressed on anti-HER2 therapy in the metastatic or advanced setting.
~The study is ongoing, results are reported as of the data cut off date of 28 February 2017."
725821|NCT02091921|Patients with diagnosis of CLI (Rutherford class IV, V and VI) on continuous dual antiplatelet therapy with clopidogrel 75 mg and aspirin 81 mg daily for at least 14+2 days|"A total of 53 patients consented and enrolled the study. 3 patients were excluded from the study and did not complete the study; one developed a skin reaction after the first IP dose; the other two due to events unrelated to the study (Pneumonia and Rheumatoid arthritis pericarditis).
~50 Patients completed the study."
725822|NCT02091869||
725823|NCT02091856||
725824|NCT02091778||
725825|NCT02091752||
725826|NCT02091739|The study was conducted at 12 sites in Poland and Germany.|A total of 216 participants were screened for the study, of which 184 participants were randomized and treated in the Main Period (MP) of the study. A total of 173 participants who completed the MP, entered the 2 treatment arms of the Extension Period (EP) of the study.
725827|NCT02091726|"Three generalist physicians (GPs) performed the circumcisions in individual consultation rooms in their own primary health care clinic.
~The study took place between January 20 and July 4, 2014."|
725828|NCT02091531||
725829|NCT02091466|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section, between March 18, 2010 and July 17, 2010 - assisted at the Obstetric Clinic of Santa Casa de Misericórdia de São Paulo.|Patients with fever (peripheral temperature > 37.8 Celsius) and/or infectious conditions, familial history of potential malignant hyperthermia, body mass index (BMI) values below 18.5 Kg.m-2 or above 36 Kg.m-2, thyroid disorders, dysautonomia, Raynaud's syndrome, and those in labor were excluded.
725830|NCT02091440||
725831|NCT02091414||
725832|NCT02091375||
725834|NCT02091284|AUD patients of both genders were successively recruited between June of 2015 and January of 2018 from three specialized clinics for drug dependence treatment, one public and two privates, from the State of Espírito Santo, Brazil.|
725835|NCT02091206||
725836|NCT02091167|There were two dropouts in the sham-tDCS group that were excluded after randomization. One patient escaped from the treatment facility and the other had to be discontinued because of precocious discharge from the clinic for misconduct.|
725837|NCT02091102||
725838|NCT02091089||
725839|NCT02090959|All participants who successfully completed the double-blind, placebo-controlled Phase 3 study (PTC124-GD-020-DMD [NCT01826487]) were screened for this open-label extension study.|A total of 221 participants completed the double-blind Phase 3 Study PTC124-GD-020-DMD. Of the 221 participants who completed Study PTC124-GD-020-DMD, 219 participants were enrolled in this open-label extension study and 218 were treated.
725840|NCT02090894||
725841|NCT02090855|This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.|
725842|NCT02090777|9 participants signed consent. 5 participants decided not to participate after signing consent and did not start study. 4 participants started and completed the study.|
725843|NCT02090764|Patients were enrolled at 34 sites in Germany, Puerto Rico, Romania, Russia, South Africa, Spain and the United States of America (USA).|
725844|NCT02090725||
725845|NCT02090426||
725846|NCT02090413||
725847|NCT02090283|42 participants with epidermolysis bullosa (EB) were enrolled in this open-label, multi-center extension study. All enrolled participants had previously completed Study SD-003 (NCT02014376).|Analysis groups were defined based on prior treatment in Study SD-003: those who received placebo were allocated to the 'Placebo to SD-101-6.0' group, those who received SD-101-3.0 were allocated to the 'SD-101-3.0 to SD-101-6.0' group, and those who received SD-101-6.0 were allocated to the 'SD-101-6.0 to SD-101-6.0' group.
725848|NCT02090088|"The registry was initiated in May 2009. The first participant enrolled in June 2010 and the last participant enrolled in December 2013.
~Eligible participants were currently pregnant women residing in the United States who had any exposure to Nplate at any time during pregnancy."|The Nplate® Pregnancy Exposure Registry (NPER) was to continue the follow-up of enrollees until April 2016; however, the NPER was terminated on 24 January 2014 because of the low number of participants enrolled.
725849|NCT02090075||
725850|NCT02089997|Participants took part in the study at 606 investigative sites in Japan from 27-May 2013 to 30-April 2016 .|Participants with a historical diagnosis of osteoporosis were enrolled to receive sodium risedronate 75 milligram (mg) for up to 12 months as per routine medical practice.
725851|NCT02089737|Participants enrolled during the period from June 1, 2010 to November 14, 2010 were surveyed.|Surveyed participants had a clinical diagnosis of wild-type KRAS unresectable advanced/recurrent colorectal cancer.
725852|NCT02089659|Part 2 of the study was to enroll participants only if a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1. Because this was not observed, no participants were enrolled in Part 2 of the study.|
725853|NCT02089464||
725854|NCT02089347|The study participants were enrolled from 01 March 2014 through 31 May 2014 at 21 clinic centers in Japan.|A total of 533 participants who met all of the inclusion criteria - including having completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese-produced DTaP vaccine), and none of the exclusion criteria were randomized and vaccinated in this study.
725855|NCT02089334||
725856|NCT02089191|Subjects were recruited from 1 investigational site located in Germany.|
725857|NCT02089113||
725858|NCT02088957|Sixty subjects were planned to be screened in order to enroll 50 subjects in a 1:1 ratio to intravenous (iv) Brivaracetam (BRV) or iv Phenytoin (PHT) with stratification based on categorized age (<65 years versus ≥65 years) across approximately 15 sites.|This study was stopped due to low enrollment; the termination date was 17 Nov 2014. One subject enrolled, but discontinued from the study prematurely due to lack of efficacy.
725859|NCT02088905|"Recruitment began June 2014, with clinicians at the Merck Center for Autism and Developmental Disorders or from the Child Development Unit bringing up the study to patients.
~140 subjects were excluded during phone screen. 77 did not meet inclusion criteria, 39 declined consent due to high burden of time/procedures, 24 refused for other reasons."|Two subjects of the originally enrolled 25 were discovered to have not met inclusion criteria. Upon the discovery, they were removed from the study and not randomized to any study condition.
725860|NCT02088788||
725861|NCT02088541||
725862|NCT02088385||
725863|NCT02088216||
725864|NCT02088177|This trial was conducted at the Substance Treatment and Research Service (STARS), a research clinic at Columbia University Medical Center and the New York State Psychiatric Institute in New York, NY. Participant recruitment began in October 2014 and concluded in January 2016, with data collection completed in March 2016.|All participants were assigned to treatment with injectable naltrexone under open-label conditions. The first injection was given on study day 1.
725865|NCT02088073|Participants took part in the study at 44 sites in the United States, Australia, and South Africa from 31 March 2014 to 08 August 2014|Subjects with hyperkalemia (i-STAT potassium value ≥ 5.1 mmol/L) were enrolled in the Acute Phase (AP) and were to be treated with ZS 10 g TID for the 48 hours.Subjects who achieved normokalemia during the AP were randomized to 1 of 3 doses of ZS (5 g, 10 g,or 15 g) or placebo for a further 28 days (Maintenance Phase [MP]).
725866|NCT02088047||
725867|NCT02088034||
725868|NCT02087995||
725869|NCT02087956||
725870|NCT02087943||Treatment assignment was stratified by geographic region and within each region, by the Eczema Area and Severity Index (EASI) score (≤ 20 or > 20). Six participants were excluded from analysis due to unsigned case books; a total of 185 participants were included in the final analyses.
725871|NCT02087904||The study included a screening period (approximately 45 days prior to first study drug dose) and a washout period (5 half-lives of the longest acting analgesic used, or 48 hours, whichever was longer, in which all standard of care analgesic medications were discontinued prior to the first study drug dose).
725872|NCT02087774||
725873|NCT02087748|"Dates of recruitment period: First subject was enrolled in March 2014 and the last subject was enrolled in April 2014.
~Types of location: Investigative site was located at one research center."|
725874|NCT02087670|Outpatient with heart failure were recruited since March 2005 to January 2008.|
725875|NCT02087514||
725876|NCT02087423|First patient in: 25 Feb 2014; Last patient in: 28 Dec 2015. Primary Analysis data cut-off (DCO): 03 Jun 2016; Final Analysis DCO: 7 Nov 2017. Patients were treated with durvalumab (10 milligrams [mg] / kilogram [kg] every 2 weeks [Q2W] intravenously [iv]). 101 sites in 16 countries treated patients in this study.|Patients were enrolled in 3 cohorts. Cohort enrolment was dependent upon epidermal growth factor receptor (EGFR) / anaplastic lymphoma kinase (ALK) status and programmed cell death ligand-1 (PD-L1) expression level (percent of tumor cells [TC] with membrane staining).
725877|NCT02087241|The study was conducted at 16 clinical sites in the United States. A total of 14 subjects were enrolled between March 19, 2014 and April 16, 2015.|22 subjects were consented; 3 subjects failed screening. The study was terminated prior to the start of screening for 5 participants. 14 participants were treated with AZD1775. The study was terminated early by the sponsor. Part 2 was not done. The 14 participants were enrolled in 4 Cohorts, designated Cohorts 1, 2, 3, and A.
725878|NCT02087176|The study was conducted at 12 clinical sites in the United States. A total of 32 subjects were enrolled between May 20, 2014 and January 22, 2015.|48 participants were screened. 16 did not meet criteria. In Part A, 32 participants were enrolled. The study was terminated early by the sponsor. Part B of the study was not done.
725879|NCT02087163||
725880|NCT02087150||
725881|NCT02087085||
725882|NCT02087059||
725883|NCT02086968|This study was conducted at 41 study centers in the United States. The first subject was screened on 06 February 2014 and the last subject was completed on 07 July 2016.|
725884|NCT02086786||
725885|NCT02086708|1. Patients scheduled for Liver Biopsy 2.|
725886|NCT02086682|338 patients were enrolled at the Mayo Clinic in Rochester, Minnesota from January 2014 to May 2015.|
725887|NCT02086591||
725888|NCT02086565||We intended to enroll 300 participants. Because several research coordinators were working at once, and calls were pending to patients, we identified and enrolled and randomized 301 participants..
725889|NCT02086552||
725890|NCT02086500||
725891|NCT02086331||"This study was terminated early after the proof of concept stage. We showed that our methodology worked in healthy subjects, then ran out of time thus no participants were enrolled in either the Symptomatic peripheral arterial disease or Symptomatic diabetic peripheral neuropathy arms."
725892|NCT02086162||After participating in an informed consent process, 184 subjects were assessed for eligibility. 11 were ineligible and 11 declined or were unable to proceed with the study for other reasons. 162 were randomized and proceeded to receive an intervention.
725893|NCT02086110||
725894|NCT02085785||"303 participants were contacted to recruit them into the study [VHA patient (n=237) and UWMC or Harborview patient (n=56)] and 10 individuals contacted study personnel expressing an interest in participating (n=313)
~15 participants were consented and enrolled, but 313 individuals will be assessed for the purpose of assessing feasibility"
725895|NCT02085720||
725896|NCT02085551||
725897|NCT02085473|This study was conducted between 19Mar2014 and 10Jul2014.|A total of 149 participants were screened for the study, out of which 60 participants were randomized and completed in the study.
725898|NCT02085447||
725899|NCT02085356||
725900|NCT02085252|Participants took part in the study at 22 investigative sites in France from 03 June 2013 to 08 November 2016.|Participants with a diagnosis of Prostate Cancer were randomised equally to one of two arms: leuprorelin 11.25 mg or active surveillance. 116 participants were randomized but 1 patient was excluded due to absence of prostate cancer before treatment.
725901|NCT02085161||An exploratory, randomised, partially double-blinded, placebo-controlled, parallel group trial to explore the effects of tiotropium + olodaterol fixed dose combination (FDC) or tiotropium, supervised exercise training and behaviour modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)
725902|NCT02085135|Subjects were diagnosed with major depressive disorder (MDD) and had an inadequate response to 1 or 2 adequate courses of treatment with a commercially available antidepressant therapy (ADT) during the current major depressive episode (MDE). All subjects continued ADT for the duration of the study.|
725903|NCT02084797||Participants received all three interventions in randomized fashion.
725904|NCT02084706||
725905|NCT02084628|Study was conducted at 9 centres in United States of America (USA) and only one participant was recruited in one centre, between 13 February 2015 (first subject first visit) and 11 August 2015 (Last subject last visit).|One participant was enrolled in the study.
725906|NCT02084511||This was a randomised, placebo and active comparator-controlled, partially double-blinded, single-dose, parallel-group, single-centre trial in male patients in double dummy design investigating 4 different treatments.
725907|NCT02084238|Between August 2013 and May 2014,38 patients completed three cycles of recombinant human IL-2 (rhIL-2) in Dept. of Rheumatology and Immunology, Peking University People's Hospital. Patients were permitted changes in background therapy according to the treating physician's advice.|All the patients showed poor efficacy at least 4 weeks of stable routine treatment at the time of enrollment. Two of the enrolled patients withdrew from the study at week 8: one changed to the belimumab treatment by personal preference; the other elected changed to the cyclophosphamide treatment to reduce the frequency of hospital visits.
725908|NCT02084160||
725909|NCT02084147||
725910|NCT02084134||
725911|NCT02084082|"The study is conducted in two parts:
~Part 1 of the study was conducted in fasting conditions. Part 2 of the study was conducted in fed conditions."|
725912|NCT02084069||
725913|NCT02084056|This study was conducted in two parts. Part 1: Fasting study Part 2: Fed Study|
725914|NCT02083965||
725915|NCT02083861||
725916|NCT02083809||
725917|NCT02083783||8 subjects not randomized.
726188|NCT02062645|One hundred thirty patients were screened and 115 were enrolled into the trial.|
725918|NCT02083679|The trial was conducted at 5 clinical trial sites within France and the United States. First subject first visit: 03 July 2014 and last subject last visit: 31 August 2015. Clinical data cut-off date: 16 September 2015|This study was planned to be conducted in 2 parts; Part 1 was the dose escalation part and Part 2 was the expansion cohort. However, due to premature termination of the trial by the Sponsor, the Expansion Cohort (Part 2) was not conducted.
725919|NCT02083653||
725920|NCT02083406||
725921|NCT02083380|Randomized double blind study. Conduct was July 2014-August 2015 in Africa (Benin, Burkina Faso, Democratic Republic of Congo, Gabon, Mozambique and Uganda) and Vietnam. Following informed consent patients were recruited to the study. Patients below the age to give legal Informed Consent were consented according local customs / legal requirements.|Patients were assigned a screening number and underwent screening procedures to assess eligibility. Eligible patients were randomized through an Interactive web-response system and followed for efficacy and safety up to 42 days post dose and 63 days at selected centers. Patients were consented separately to remain in the study up to Day 63.
725922|NCT02083263||
725923|NCT02083185|Participants took part in the study at 23 investigative sites in Canada and the United States from 26 March 2014 to 23 February 2017.|Participants with a diagnosis of prostate cancer were enrolled in 1 of 2 dose levels of TAK-385 (80 or 120 mg) or leuprorelin 22.5 mg.
725924|NCT02083107||
725925|NCT02082977|This was a 2-part study in participants with relapsed/refractory diffuse large B cell lymphoma, transformed follicular lymphoma, other Non-Hodgkin's lymphomas, solid tumors and multiple myeloma (MM). In Part 1 dose escalation, participants received 50 to 3000 milligrams (mg) of GSK2816126, and Part 2 was dose expansion.|This study was terminated prior to the completion of Part 1 due to an unfavorable benefit risk profile. Part 2 was not conducted. Approximately 42 participants screened, of which 41 were treated in Part 1 including 20 participants with lymphoma and 21 with solid tumors, of these 22 completed, 5 died and 14 participants were withdrawn.
725926|NCT02082912|Participants were recruited from the Center for Rehabilitation Medicine at Emory University in Atlanta, Georgia. Enrollment of participants began in June 2010 and study participation ended in April 2012.|A total of 124 patients were screened and of these 14 met enrollment criteria and consented to participate in the study.
725927|NCT02082769||
725928|NCT02082678||
725929|NCT02082522||An independent expert panel acted as central assessors for subjects across all sites. Central assessors prospectively interpreted all abdominal CT and cholangiogram images taken at screening to establish the final diagnosis and to confirm the randomization. Central assessors had the authority to overrule the investigator's diagnosis.
725930|NCT02082483||
725931|NCT02082392|Recruitment will be coordinated through the Adult and Late Life Depression Research Clinic and will include flyers posted around Columbia University Medical Center (CUMC), information posted on the CUMC internet website, advertisements in local newspapers and on radio stations, and outreach to CUMC clinical staff.|Interested individuals will contact the ALLDRC coordinator, a telephone screening will take place to identify obviously ineligible subjects. Potentially eligible subjects will be scheduled for an evaluation in the ALLDRC, including a clinical interview by a study clinician (psychiatrist or psychologist) and diagnostic rating by trained rater.
725932|NCT02082340|Between 12 March and 26 December 2014, we identified and contacted eligible TB patients from the intervention TB out-patient clinics as well as the control TB out-patient clinics.|
725933|NCT02082288||
725934|NCT02082262||
725935|NCT02082210|Part A: Completers are those who have completed one cycle of treatment. Part B: Completers are those who 1)Have measurable disease at baseline and at least one post-baseline tumor assessment; and 2) Were treated until PD or death, or discontinued due to an AE and completed the required follow-up.|Two part study, Part A with 2 cohorts (750 milligram (mg), 2000mg) & Part B with four tumor specific cohorts (gastric, hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC)).
725936|NCT02082184||A total of 302 subjects consented and enrolled into the study. Seventy-eight (78) of these failed screening or withdrew before randomisation. Two hundred and twenty-four (224) subjects were randomised and 201 completed the study.
725937|NCT02082158||This study compares multiple respirators using same intervention (study activities). All subjects that pass fit-testing move on to intervention.
725938|NCT02082145||
725939|NCT02082119|Considering a time of enrollment of 2 years and a follow-up time of 2 years, 82 patients are evaluated from June 2013 to May 2015. Patients with newly diagnosed HGGs underwent hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, after biopsy, subtotal or gross total surgical resection.|
725940|NCT02081963|Eligible patients were screened and randomized at five tertiary hospitals in Shandong Province, China.|A total of 178 patients were screened in this study, and 26 unquali-fied patients (14.6%) were excluded.
725941|NCT02081950|No details are specified in the CSR|This is a single arm study and not a parallel group study. This means that the participants are 14 in total. The 14 eligible subjects received 1 dose of s.c. Clexane in Treatment Period 1 and 1 dose of S.C. Clexane in Treatment Period 2 (1 dose/period). Each Treatment Period was of 2 days duration.
725942|NCT02081859||
725943|NCT02081846|Patients hospitalized on the hospital medicine or neurosciences services (neurology/ neurosurgery) at Cincinnati Children's Hospital Medical Center (CCHMC), a freestanding tertiary care children's hospital, between 2/2015 and 4/2016 were eligible for study recruitment.|
725944|NCT02081807|Data for the patients included in this cohort study arose from two de-identified research databases, US MarketScan and Optum Research Database|In this non-interventional study based on existing data, no patients were screened.
725945|NCT02081690|The study was designed to recruit 160 male and female patients aged 18 to 80 years (inclusive) with PAH. A total of 93 patients were screened and 88 patients were enrolled at 37 recruitment sites. Due to slow recruitment, the sponsor decided to prematurely stop the study.|
725946|NCT02081677||A total of 80 subjects were enrolled in this study. Of the enrolled subjects 4 did not meet the eligibility criteria and 76 were randomized to receive a study lens. Of the randomized subjects 72 completed the study.
725947|NCT02081638||
725948|NCT02081599||
725949|NCT02081586||
726224|NCT02059642||
740065|NCT01172808||There was 1 patient in the TIO R5 group randomized but not treated.
725950|NCT02081573|Participants were recruited from a existing cases of nurse care managers and health coaches who administered the study intervention. Individuals who were interested and had HbA1C higher than 8.0 were screened.|Screened to have mean distress over 2.0 and HbA1C of 8 or above via measurements by our tests.
725951|NCT02081534||
725952|NCT02081456|Between November 2009 and June 2012 consecutive patients with neck and arm pain presenting to Cayuga Medical Center's Physical Therapy Department were screened for eligibility criteria|Patients were excluded if they exhibited Red flags in the medical screening questionnaire such as tumor, fracture; had signs of CNS involvement such as hyper-reflexia, ataxia, nystagmus, etc. Cervical spine surgery within 3 months. Litigation, insufficient English language skills, inability to complete study schedule, or were pregnant.
725953|NCT02081443|Patients were recruited from October 2014 to October 2015. Patients were screened and recruited in the Cardiology clinics of the Division of Cardiology of University of Florida Jacksonville.|64 patients were consented for the study. Of these, 3 withdrew from the study before being randomized, 1 had an exclusion criteria. A total of 60 patients were randomized to receive study medications.
725954|NCT02081417||Because of this difficult to engage population, participants were consented and baseline data collected after they were randomized to a study arm and completed their first treatment group.
725955|NCT02081391|The trial started on 19 Feb 2015 with the enrollment of the first participant. Recruitment of participants aged 2 to <18 years old was completed on 05 Dec 2016 with the last participant out. Recruitment of the remaining participants aged from birth to <2 years old was completed on 14 Mar 2019.|A total of 216 participants (or parents/caregivers) gave informed consent to participate in the trial, 180 of these participants were allocated to study drug (investigational medicinal product = IMP) and 175 participants received IMP (56 participants received placebo oral solution and 119 participants received tapentadol oral solution).
725956|NCT02081365||
725957|NCT02081248||
725958|NCT02081183|Protocol Approved by National Regulatory Agency on 25 October 2005 and inclusion period ended on 21 January 2008, on three investigational sites but only two sites included patients. Sites were selected in public health care systems.|Screening period include only the assessments to verified the inclusion and exclusion criteria's from ICF signature until base line visit (first dose day), no washout or run in period was expected.
725959|NCT02081079|Participants were enrolled at study sites in France. The first participant was screened on 07 March 2014. The last study visit occurred on 17 February 2015.|91 participants were screened.
725960|NCT02081014|A total of 13 adults < 50 years of age with type 1 diabetes were recruited over a period of 5 months to receive treatment at a university-affiliated state hospital-based endocrinology clinic.|A total of 13 subjects were randomized to treatment. Due to poor venous access an IV could not be started in one subject, so only 12 subjects received treatment.
725961|NCT02081001|A total of 19 adults ages 18-65 years with type 1 diabetes were recruited over a period of 4 months to receive treatment at a public university hospital.|A total of 30 subjects were screened for study inclusion. The 19 subjects who met all eligibility criteria were randomized and assigned to treatment.
725962|NCT02080871||
725963|NCT02080832||"For some consented participants, the imaging scan (MRI) quality was not sufficient to include those participants in the outcome analysis. These participants are captured by theexcluded from analysis by MRI category. fMRI data was only analyzed from participants who underwent MRI scans at UT Houston which can't be combined with MRI scans at VCU."
725964|NCT02080819||
725965|NCT02080780||
725966|NCT02080637||
725967|NCT02080546||19 subjects either withdrew or were excluded from the study. Thermal injury could not be assessed in 18 specimens because of sampling error.
725968|NCT02080507|Participants were recruited March 2014 through August 2015 from the Emory University Outpatient Psychiatry Department and the Atlanta community. Of the 16 participants who consented for participation, 12 began study treatment.|Participants taking psychotropic medications were required to be stable on a stable dose for at least six weeks.
725969|NCT02080481||
725970|NCT02080468||
725971|NCT02080455||
725972|NCT02080312||
725973|NCT02080273|recruitment completed by the principal investigator at the clinical site.|None. There is no wash out/pre-trial period for enrolled subjects. All accepted subjects were randomized upon study enrollment.
725974|NCT02080260||
725975|NCT02080195||
725976|NCT02080091||
725977|NCT02079987|Medicare beneficiaries with at least 1 chronic medical condition who presented to the ED during the study period were eligible for study entry. Recruitment dates were 5/3/14-11/30/15. Location types: two hospital EDs in north central Florida|1322 subjects signed an informed consent. 221 subjects were not included in the analysis because: 1) they did not have a unique Medicare ID; 2) no claims matching the date of index ED visit (informed consent date); 3) not enrolled in Medicare A & B for 12 months prior to index ED visit and at least 30 days after the ED visit.
725978|NCT02079909||
725979|NCT02079844|Participants took part in the study at 1 investigative site in the United Kingdom from 13 March 2014 to 15 June 2015.|Participants with a diagnosis of schizophrenia were enrolled equally in 1 of 3 treatment sequences which determined the order the following 3 treatments were received: placebo, once a day roflumilast 100 μg, roflumilast 250 μg.
725980|NCT02079805|Participants took part in the study at 27 investigative sites in Japan, from 04 June 2014 to 25 April 2016.|Participants with diagnosis of type 2 diabetes mellitus were enrolled in 2 treatment group: Azilsartan 20 mg, and Telmisartan 40 mg for 12 weeks as treatment period.
725981|NCT02079766|"Subjects were recruited between June 2014 and October 2015 from the DETECT study (National Institutes of Health grant R01NS078337) and the Arizona Alzheimer's Consortium (Long-Term Consequences of Repetitive Brain Injury in Athletes: A Longitudinal Study with Eventual Brain Donation)"|
725982|NCT02079649|Subjects were recruited from 1 study center located in the US.|Of the 224 enrolled, 60 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects. Note: 2 randomized subjects were exited prior to treatment.
725983|NCT02079636||Completers include participants who had cycle 1 and had received greater than or equal to (>=) 75% of Abemaciclib drug in cycle 1.
725984|NCT02079610||
725985|NCT02079532||
725988|NCT02079246||Open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or 14862A (NCT02006641)
725989|NCT02079077||
725990|NCT02079038||180 subjects enrolled; 12 withdrew, leaving 168 subjects randomized & treated.
725991|NCT02079025||
725992|NCT02078960|"A total of 14 patients with chronic myeloid leukemia were screened for enrollment into this study. Of the 4 patients who were not enrolled, 2 were excluded on the basis of inclusion/exclusion criteria and 2 for other reasons."|Of the 14 patients screened, 9 patients at 3 centers in the US and 1 patient at a single centre in France met entry criteria and were considered to be eligible for enrollment into the study.
725993|NCT02078882||
725994|NCT02078817||
725995|NCT02078752||
725996|NCT02078713|"Female patients were approached to participate in the study before appointments at four San Francisco Bay Area clinics between December 2014 and March 2016.
~Patients are grouped in cluster by provider. Providers of family planning care at the four clinics were approached to participate in the study in October to December 2014."|"A total of 2,458 patients were approached to participate in the study. Of these, 1,700 were excluded before assignment (1,642 due to ineligibility, 58 refusals), and 758 enrolled.
~A total of 36 providers were approached to participate. Eight were excluded before assignment (7 due to ineligibility, 1 refusal), and 28 enrolled."
725997|NCT02078557||
725998|NCT02078492||
725999|NCT02078219|Of the 381 subjects who were screened in the study, 204 were randomized into one of the treatment groups. All 204 randomized subjects received at least 1 dose of randomized study medication. The first patient was enrolled on 11 March 2014 and the last enrolled patient completed the Last visit on 13 March 2015.|204 were randomized into one of the following treatment groups; allopurinol, placebo, RDEA3170 Group 1, Group 2 and Group 3. Of the enrolled subjects, 177 were withdrawn prior to randomization because of 'eligibility criteria not fulfill' (176 subjects) or 'patient decision' (1 subject).
726000|NCT02078193||
726001|NCT02078180||
726002|NCT02077465|Participants were enrolled at study sites in United States. The first participant was screened on 11 March 2014. The last study visit occurred on 27 October 2014.|33 participants were screened.
726003|NCT02077374|In total, 71 subjects were screened at 7 sites, and 38 subjects were randomized and treated to a BID treatment with either placebo or IDN-6556 25 mg with 19 subjects in each arm.|38 subjects were randomized and treated (19 each arm). 2 subjects on placebo discontinued before Day 28 and 1 discontinued after Day 28, but returned for their Day 56 visit, so 17 subjects completed the study. However, all 38 were included in the analyses using the last results provided for the 2 subjects at early termination.
726004|NCT02077140|The study was planned to enroll 3 sequential cohorts, the 4th cohort was added after data review from Cohort 1-3. In each cohort, 48 subjects were randomized in a 3:1 ratio (investigational vs. control). The investigational subjects were implanted MDT-10013 strips in surgical wound while control subjects received standard of care for pain control.|
726005|NCT02076919|Subjects were recruited from a single investigational site located in the US.|Of the 110 enrolled, 30 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (80).
726006|NCT02076776||One participant consented to the study, but had abnormal stress test results. This participant declined follow-up care and withdrew from the study before completing the baseline and randomization process.
726007|NCT02076425||
726008|NCT02076412|74 patients were enrolled from January 2015 to August 2016|
726009|NCT02076399|76 patients were enrolled from July 2014 to April 2016|
726010|NCT02076334||
726011|NCT02076321||
726012|NCT02076243||
726013|NCT02076178|This study was conducted at 10 centers in United states. Participants who received study medication are being followed for 52 Weeks following their last injection while those in placebo group were followed until all participants completed Week 41. The first subject's first visit was 27-Mar-2014 and the last subject's last visit was 15-May-2015.|A total of 205 participants were screened of which 78 participants were not randomized. The remaining 127 participants were randomized to the study treatment who entered the oral and injection phase. Out of this, one participant randomized but withdrawn consent prior to treatment.
726014|NCT02076165|347 subjects were enrolled into the study (i.e., signed consent) and were administered the baseline assessment. Final eligibility determination was made after baseline assessments. Only participants who met final inclusion/exclusion criteria (after baseline) were eligible for randomization. Results are only provided for the 149 randomized subjects.|
726015|NCT02076100|Males or females of non-child bearing potential, with verified Hepatitis C virus (HCV) infection with genotype (GT) GT1a, GT2b or GT3 between the ages of 18 and 65 years (inclusive) were enrolled in this trial. In the GT1a group, one participant was later determined to be GT1b.|
726016|NCT02076022||
726017|NCT02076009||
726018|NCT02075840|The study recruited treatment-naive participants with Anaplastic Lymphoma Kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) in 29 countries from August 2014 to January 2016.|A total of 303 participants were randomized at the time of clinical cut-off (CCO) date on 9 February 2017 and included in the intent-to-treat (ITT) population; 152 participants in the alectinib arm and 151 participants in the crizotinib arm.
726019|NCT02075658||Competent adults (>18 years old)(male or female) undergoing laparoscopic/robotic renal or peri-renal procedures will be included in this study.
726020|NCT02075632|Participants were recruited at the clinical site|Participants with itchy skin conditions, who would use OTC treatments for relief
726021|NCT02075606|Recruitment to this prospective, pilot, phase IV, multicentre, open-label, single-group study began on 16 May 2014. Subjects with a documented diagnosis of functioning midgut NET and who suffered from symptoms of diarrhoea and/or flushing at the time of enrolment were recruited to 11 study centres in the United Kingdom.|Overall, 54 subjects were screened, 50 of whom were enrolled and treated in the study.
726022|NCT02075541|145 subjects, aged 40 to 80 years were recruited from 4 sites in Sweden and 11 sites in the United Kingdom.|All enrolled subjects were included in the study.
726023|NCT02075515||
726024|NCT02075476||
726257|NCT02058095||
726258|NCT02058069||
726259|NCT02057952||
726025|NCT02075463|Eligible hemodialysis-dependent participants (par.) with anemia associated with chronic kidney disease and chronically hyporesponsive to recombinant human erythropoietin (rhEPO) (for 12 weeks) were switched from a stable dose of rhEPO|Study consisted of run-in period of 4 weeks (wk), 16-wk Treatment Phase and Follow-up period of 4-wk after completion of treatment.
726026|NCT02075411|Beginning in June 2014, 49 potentially eligible patients were identified. Of these, 35 patients did not meet inclusion/exclusion criteria including, and 3 patients were unable to be contacted by phone pre-operatively. Of the remaining 11 potential patients, 10 declined study participation and only 1 signed consent to participate.|Only 1 subject signed consent to participate.
726027|NCT02075320||
726028|NCT02075255||369 participants signed informed consent. 271 entered run in/OCS optimization period. 220 participants were randomized to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 220 patients randomised, all (100.0%) received treatment with study drug
726029|NCT02075203||
726030|NCT02075125||
726031|NCT02075073||
726032|NCT02075021|Confirmed diagnosis of relapsed/refractory multiple myeloma.|
726033|NCT02075008||This was an open-label, single arm study for participants who completed the core study CQGE031B2201 (NCT01716754).
726034|NCT02074995|The study was planned to have 4 groups of patients. In Group 1: the bioavailability of BVS857 following subcutaneous administration was planned. Groups 2-4 (Group 4 optional) different BVS857 doses were planned for safety, PK and efficacy assessments. Study was terminated due to low enrollment as only 1 patient was enrolled|
726035|NCT02074982|Of the 676 patients who were randomized to the study, 571 patients completed the study (286 patients (84.9%) in the secukinumab group and 285 patients (84.1%) in the ustekinumab group. Efficacy Data up to 52 weeks and Safety Data included up to 104 weeks|
726036|NCT02074904||
726037|NCT02074735||
726038|NCT02074709|A total of 67 patients were assessed for eligibility and 60 patient enrolled to the study.|
726039|NCT02074553||
726040|NCT02074514|Participants were enrolled at study sites in India. The first participant was screened on 31 March 2014. The last study visit occurred on 30 November 2015.|
726041|NCT02074384||
726042|NCT02074358|Study initiated in February 2014 in healthy adult participants and completed in April 2014. Participants were admitted to a clinical facility on the evening prior to dosing and remained in the facility for at least 72 hours after the start of the IV infusion on Day 4.|43 enrolled;15 treated. Reasons not treated: 5 withdrew consent; 19 no longer met study criteria; 4 stand-by participants not needed (cohort full). Crossover: 6 treatment sequences (3 periods) with an 11 day washout from study drug between each treatment period; 3 participants in each sequence: ABC, ACB, CAB and 2 in each sequence: CBA, BAC, BCA.
726043|NCT02074345|Participants took part in the study at 4 investigative sites in Japan from 13 March 2014 to 25 March 2015.|Participants received open-label TAK-816 0.5 mL vaccinations, 3 initial doses and 1 booster.
726044|NCT02074059||
726045|NCT02073968||
726046|NCT02073929||
726047|NCT02073747|Healthy volunteers were recruited from the investigators' friends and family.|
726048|NCT02073682|1050 participants were randomized from 114 sites in Western Europe (31), Central Europe (11), South Europe (36), Australia/New Zealand (13) and North America (23)|Of 1050 participants randomized, 1046 took study drug and were included in the modified Intent to Treat (mITT) and Safety Analysis Sets
726049|NCT02073656|Participants were enrolled at study sites in the United States (including Puerto Rico), Canada, and New Zealand. The first participant was screened on 24 February 2014. The last study visit occurred on 01 December 2015.|429 participants were screened.
726050|NCT02073643||
726051|NCT02073565||
726052|NCT02073461||
726053|NCT02073448||
726054|NCT02073435||
726055|NCT02073331||
726056|NCT02073279|The Double-blind (DB) period lasted up to the clinical cut-off date (CCOD: 12 Oct 2018) when the study reached 1.5 years since the date of randomization of the last participant enrolled. The study is ongoing in the open-label extension (OLE) period.|Participants with neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD) were randomized 2:1 to receive either satralizumab 120 mg or matching placebo.
726057|NCT02073162||
726058|NCT02072980|Participants were recruited from 1 study center located in the US.|This reporting group includes all randomized participants (15).
726059|NCT02072941|Study participants were enrolled from four primary care clinics associated with the San Francisco Health Network from November 2014 - March 2017. They were included if they were ≥55 years old, had ≥2 chronic medical conditions, had ≥2 visits with a PCP in the past year, and had ≥2 additional outpatient/inpatient visits in the past year.|
726060|NCT02072928||
726061|NCT02072824||Participants received treatment in double-blind treatment phase (total duration: 21 days) which included dose escalation (5 days), fixed-dose (9 days) and taper (7 days).
726062|NCT02072668||15 subjects signed informed consent and were successfully screened. One subject withdrew during Baseline and prior to the first intervention and data from this individual are included in the baseline characteristics. One subject entered the second intervention period but was lost to follow up before receiving the intervention.
726063|NCT02072434||
726064|NCT02072421||
726065|NCT02072226||
726066|NCT02072200||
726067|NCT02072174||
726068|NCT02072096||Participants completed the first 24 weeks of the study at which time the study was stopped and interim analysis was triggered to assess feasibility. Treatment continued per protocol until study termination and participants discontinued at the next office study visit. Data was assessed from Baseline to last participant visit, up to 72 weeks.
726069|NCT02071914||
726070|NCT02071901||
726071|NCT02071849||
726072|NCT02071823||
726073|NCT02071810||
726074|NCT02071771|Subjects were recruited from 1 study center located in the US and 1 study center located in the UK.|This reporting group includes all enrolled participants, as treated. Note: 2 participants randomized to DACP T were exited prior to dispense due to unacceptable fit (1) and unavailable lens power (1).
726260|NCT02057939||
726075|NCT02071706|First participant enrolled on January 20, 2014. Last participant enrolled on July 07, 2014 at the Zurich University Hospital site. Subject or participant recruitment was prematurely terminated because the sponsor had determined that sufficient data was collected for regulatory submissions|Subjects/participants were enrolled in one of three study segments and received a clinically indicated PET/CT exam with radiopharmaceutical injection followed by PET/MRI scanning. Up to two subject datasets (each dataset labelled with unique subject ID) can be collected from one enrolled participant/subject.
726076|NCT02071420||
726077|NCT02071290||
726078|NCT02071225|A total of 72 participants were recruited at 20 sites in Spain.|Participants enrolled in the study had documented CD20-positive B-cell type relapsed or refractory chronic lymphocytic leukemia (CLL).
726079|NCT02071173||Participants were not randomized to received a specific lead.
726080|NCT02071108|Three investigational sites in Austria and New Zealand participated in the study. Between January 2014 and September 2014, a total of 35 subjects and 39 lesions of the superficial femoral and popliteal arteries were enrolled in the Full Analysis Cohort of the study and treated with the investigational device.|
726081|NCT02071095||
726082|NCT02071082|Participants were enrolled at study sites in North America and Japan. The first participant was screened on 25 February 2014. The last study visit occurred on 26 October 2016.|113 participants were screened.
726083|NCT02070991|Participants were screened from 28 sites across Europe and North America in 11 countries (Austria, Belgium, Canada, Czech Republic, Germany, France, Israel, Italy, Spain, Switzerland, USA).|Of the 88 participants screened 63 were randomized in a 1:1 ratio to macitentan 10 mg (N = 31) or placebo (N = 32).
726084|NCT02070978|Participants who completed 24-week of the ADDRESS II core study (NCT01972568) and didn't meet any discontinuation criteria were enrolled in this long-term extension (LTE) study NCT02070978. The study was conducted at 81 sites in 17 countries in Asia, Europe, North America, Central America, and South America.|Participants who received placebo in core study ADDRESS II were switched to receive atacicept 150 milligram (mg) as once-weekly subcutaneous injections in LTE study. Participants who received atacicept 75 mg or 150 mg in core study ADDRESS II continued to receive the respective randomized dosage as once-weekly subcutaneous injections in LTE study.
726085|NCT02070965||
726086|NCT02070757|A total of 263 sites were opened for enrollment with the majority of participants recruited from sites in eastern Europe.|Randomization was stratified by diagnosis (ventilator-associated bacterial pneumonia [VABP] or ventilated hospital-acquired bacterial pneumonia [HABP]) and by age (<65 or ≥65 years). All participants randomized were included in the intent-to-treat (ITT) population.
726087|NCT02070744||The study consisted of 2 phases: a randomized, double-blind, placebo-controlled (PC) phase in which participants received either VX-661 in combination with Ivacaftor (IVA), or matched placebo and an open-label extension (OLE) phase in which participants received VX-661 in combination with IVA.
726088|NCT02070692||
726089|NCT02070640||
726090|NCT02070588||Volunteer Control participants were scanned only for the purpose of operator training and calibrating the MRI device. No data was collected from these participants for the purpose of analysis.
726091|NCT02070484||
726092|NCT02070380|A total of 179 patients were recruited from February 2014 through February 2015 at 14 clinical trial sites. Off-site assessment of the images was performed between 19 February - 17 March 2015 by 3 board-certified neuroradiologists blinded as to which contrast agent was used, patient clinical information, and the results of other imaging studies.|179 patients were enrolled and signed informed consent. Each enrolled patient was randomized and 177 were dosed with at least one contrast agent.
726093|NCT02070302||
726094|NCT02070276|All consecutive patient undergone spinal anesthesia|Study began at the arrival in the operating block and ended 30 minutes after completion of spinal anaesthesia. The pre-anaesthetic phase running from time 0 to the beginning of spinal anaesthesia, the anaesthetic phase which corresponds to spinal anaesthesia gesture, followed by the post-anaesthetic phase ending 30 minutes spinal anaesthesia
726095|NCT02070237||
726096|NCT02069847||
726097|NCT02069704||
726098|NCT02069392||
726099|NCT02069379||
726100|NCT02069353||
726101|NCT02069184||
726102|NCT02069119||
726103|NCT02069093||A total of 92 participants were enrolled into the study and received study treatments of everolimus and exemestane. Of these, 86 participants were confirmed to have also received the investigational treatment of dexamethasone steroid mouthwash and comprised the full analysis set (FAS). The patient disposition is based on the FAS.
726104|NCT02069041||Participants completed the study if they completed 3 cycles or discontinued due to a DLT during the DLT assessment period.
726105|NCT02069015||
726106|NCT02068885|We recruited participants by posting flyers, newspaper advertisements, and Internet announcements.|We enrolled 234 participants for the run-in phase. Of these, 164 participants achieved at least 10% weight loss and were randomly assigned to one of three diets for the test phase (low-carbohydrate diet, n=57; moderate-carbohydrate diet, n=53; or high-carbohydrate diet, n=54).
726107|NCT02068846||
726108|NCT02068820||
726109|NCT02068768||
726110|NCT02068599|978 patients with primary OA of the knee were screened for enrollment into this study. 389 patients at 41 centers in the US met entry criteria. Of the 589 patients not enrolled, 551 were excluded on the basis of inclusion/exclusion criteria, 25 patients withdrew consent, and 8 patients were lost to follow-up before the baseline visit.|After stratification by R1150W polymorphism status: - homozygous minor allele (positive, AA), - heterozygous (positive, AG), and - homozygous common allele (negative, GG), participants were randomly assigned by interactive response technology (IRT) to receive treatment in 1 of 3 treatment groups in a 1:1:1 ratio.
726111|NCT02068547||
726112|NCT02068508|Participants took part in the study at 169 investigative sites in Japan, from 30-July-2009 to 30-June-2014.|Participants with a historical diagnosis of type 2 diabetes mellitus who failed to respond adequately to treatment with insulin therapy were enrolled to receive pioglitazone 15 milligram (mg) - 30 mg for up to 12 months. Participants received interventions as part of routine medical care.
735981|NCT01405313|Clinic population already established on ASV therapy.|All enrolled participants continued through to group assignment.
726113|NCT02068495|Participants took part in the study at 579 investigative sites in Japan, from 15 June 2010 to 31 May 2013.|Participants with a historical diagnosis of hypertension were enrolled to receive Candesartan cilexetil/Amlodipine 8 milligram (mg)/2.5 mg - 8 mg/5 mg combination tablet, orally, once daily for up to 12 months.
726114|NCT02068443|Participants took part in the study at 34 investigative sites in Japan from 06 February 2014 (first patient to sign the informed consent form) to 28 February 2015.|Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled equally in a 2:2:1 ratio to 1 of 3 treatment groups: alogliptin in combination with 500 mg total dose metformin hydrochloride administered either once a day (QD) or twice a day (BID) and alogliptin alone.
726115|NCT02068222||
726116|NCT02068157||
726117|NCT02068027||
726118|NCT02067858||
726119|NCT02067728|This was a randomized controlled trial comprised of 12 primary care clinics within the Peoria, Illinois region, providing well-child care to children ages 4-17 years. Clinics were a combination of pediatric, medicine/pediatric, and family medicine clinics. Study group assignments were determined by size, specialty, and socioeconomic demographics.|Practices were paired and then randomized to assure similarity across intervention and usual care groups. A total of 35 Providers participated and 430 children/family were enrolled into the project.
726120|NCT02067676|48 subjects participated at the Walter Reed Army Institute of Research (WRAIR), Clinical Trials Center (CTC).|
726121|NCT02067663|This prospective cohort trial was conducted at 2 affiliated teaching hospitals: University of Colorado Hospital (UCH) in Aurora, CO, and Denver Health Medical Center (DHMC) in Denver, CO.|
726122|NCT02067611||
726123|NCT02067585||
726124|NCT02067533||
726125|NCT02067468|After a great effort, due to logistic issues, it was only possible to enroll 2661 participants instead of 3000 as it had been stated in the submitted protocol. Despite it, the trial had enough statistical power to answer the research questions.|
726126|NCT02067273||
726127|NCT02067104||
726128|NCT02067039|Recruitment occurred from 3/2015 through 8/2015. Subjects were recruited online from internet (websites and music) catering to MSM.|Participants who did not provide contact information, complete and submit their baseline interview online, provided fraudulent information or later reported an HIV diagnoses before study enrollment were excluded.
726129|NCT02067000||
726130|NCT02066922|Participants were recruited from 2 study centers located in the US and 2 study centers located in Germany.|Of the 19 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (15).
726131|NCT02066896|The study sample consisted of 66 patients who were selected from 84 patients referred from ophthalmology and rheumatology division of university hospital. The patients met primary Sjögren's criteria (2002).|The exclusion criteria were: sarcoidosis, uncontrolled thyroidopathy, HIV and HCV infections and head or neck irradiation history. A computer-generated randomization list was used to allocate patients ramdomly into two groups: active laser therapy and sham laser therapy. Concealed randomization was performed with opaque sealed envelopes.
726132|NCT02066857|Participants were recruited from the Emory Orthopaedic Fracture Clinic from April 2014 to November 2014.|
726133|NCT02066792||
726134|NCT02066740||
726135|NCT02066727||The patients with the following condition was excluded from the study: ASA III orIV; weight <50 or >100 kg；BMI<19 or >30kg/m2；age younger than 18 yr or older than 80yr；preexisting neurologic deficits of the lower extremities, DM; alcohol or drug abuse; abnormal coagulation function
726136|NCT02066467|The first subject was enrolled on 10 February 2014. The clinical phase of the study was completed on 30 September 2016 which was the date of the last subject's close-out visit. A total of 863 subjects across 82 centers were enrolled in the study in Europe, Asia and South America.|
726137|NCT02066415|"This study was conducted at 69 centers in Canada, Czech Republic, Denmark, Germany, Finland, Norway, Poland, Sweden, United Kingdom, and the United States of America (USA).
~The first participant was enrolled on 05 March 2014 and the last participant enrolled on 05 November 2015."|Participants were randomized in a 3:2:2 ratio to receive placebo, erenumab 70 mg, or erenumab 140 mg. Randomization was stratified by region (North America vs Other) and medication overuse status at baseline (Yes vs No).
726138|NCT02066402||
726139|NCT02066389|A total of 300 adults with rheumatoid arthritis (RA) were enrolled at 59 study sites located in 16 countries.|"Eligible participants were randomly assigned in a 1:1:1:1:1:1 ratio to receive 1 of 5 doses of upadacitinib or placebo for 12 weeks.
~Participants who completed the 12-week treatment period completed a 30-day follow-up visit or had the option to enter an open-label extension study M13-538 (NCT02049138)."
726140|NCT02066311||
726141|NCT02066298||
726142|NCT02066233||
726143|NCT02066181||
726144|NCT02066129||
726145|NCT02066051|Subjects were recruited from the Mayo Clinic in Arizona.|
726146|NCT02065895|Written informed consent was obtained from all 8 participants at the Joslin Diabetes Center. All study related activities were conducted at the Center for Clinical Investigations at the Beth Israel deaconess Medical Center.|
726147|NCT02065791||A total of 12900 participants were pre-screened, of those, 8932 were screened. A total of 4401 participants were randomized, with 2199 and 2202 participants assigned to placebo and canagliflozin 100 milligrams (mg), respectively.
726148|NCT02065713|GO-DACT was a proof-of-concept multicentric, investigator-initiated trial conducted between August 2014 and June 2017, in 13 Rheumatology centres in Portugal.|
726149|NCT02065622|"This study included a Main Study (120 sites in 19 countries) and a Japan Sub-Study (22 sites in Japan).
~After a 3-week screening period, participants were randomized 3:2 to an 8-week double-blind (DB) Induction Period with 2 adalimumab dosing regimens (Induction Standard Dose [I-SD] or Induction Higher Dose [I-HD])."|At Week 8, participants in Main Study were re-randomized (2:2:1) into 44-week DB Maintenance Period with 3 adalimumab dosing regimens (M-SD, M-HD, or an exploratory Therapeutic Drug Monitoring [TDM] Regimen). Participants in Japan Sub-study were re-randomized (1:1) into 44-week DB Maintenance Period with 2 adalimumab dosing regimens (M-SD, M-HD).
726261|NCT02057874|Participants were recruited to this trial at Vanderbilt University Medical Center from 02/06/2014 to 11/19/2015. The study closed prematurely due to a loss of funding.|
726262|NCT02057835||
726150|NCT02065557|Prior to Protocol Amendment 4, participants were randomized 3:2 at baseline to adalimumab induction high dose or adalimumab induction standard dose. At Week 8, those demonstrating a clinical response per Partial Mayo Score (PMS) were randomized 2:2:1 to adalimumab maintenance standard dose, adalimumab maintenance high dose, or maintenance placebo.|"After Protocol Amendment 4, participants received adalimumab induction high dose open-label. At Week 8, those demonstrating a clinical response per PMS were randomized in a 1:1 ratio to adalimumab maintenance standard dose or adalimumab maintenance high dose. Integrated Study data includes data from both the Main Study and the Japan Sub-Study."
726151|NCT02065518||
726152|NCT02065479||
726153|NCT02065453||
726154|NCT02065336||No patients were enrolled in Cohorts 8, 11, or 12. Cohort 9 (n=2) and Cohort 10 (n=8) enrolled participants who previously completed treatment in other cohorts.
726155|NCT02064985|The first patient was recruited on February 27th 2014 and the last patient's informed consent was obtained on Oct 24th 2014.|22 participants did not meet includion/exclusion criteria. 2 participants withdrawed from study due to subject decision.1 participant withdrawed due to other reason. 36 participants were randomized and received study medication.
726156|NCT02064959|Subjects were randomized and enrolled prior to evacuation of Subdural hematoma|
726157|NCT02064920|Males and females with mild Alzheimer's Disease (AD) between the ages of 55 and 85 years (inclusive) were enrolled in this trial.|
726158|NCT02064907|Participants took part in this study from 31 January 2014 (Date first informed consent signed) to 24 April 2014.|A total of 52 healthy adult participants took part in this study at a single site in the US.
726159|NCT02064894||"Assessed for eligibility (n=5127) Excluded (n=4626)
~Not meeting inclusion criteria (n=1670)
~Excluded as per exclusion criteria (n=663)
~Declined to participate (n=874)
~Not evaluated (n=1144)
~Other reasons (n=275) Randomized (n=501)"
726160|NCT02064868||The initial target was to randomize 3183 patients. This study was prematurely terminated (due to the neutral read-out of study RELAX-AHF-2) after 2666 patients were randomized. 16 patients had not qualified for randomization but were inadvertently randomized. These 16 patients did not enter the treatment phase and were not counted as started.
726161|NCT02064816|The study was conducted at 29 clinical trial sites in Italy.|A total of 200 subjects were enrolled in the study, of which 104 were randomized to Rebif morning treatment group, and 96 were randomized to Rebif evening treatment group. A subgroup of subjects also took part in a sub study assessing cytokines and other immunological biomarkers.
726162|NCT02064582||7 met criteria and were enrolled in the trial
726163|NCT02064439|In total 3439 participants were screened at 244 sites in 31 countries from 05-Mar-2014 (First Patient First Visit) to 15-Mar-2016 (Last Patient First Visit).|Of the 3439 participants screened 43 did not complete screening. Thus, 3396 participants were randomly assigned to treatment, 31 of the randomized participants never received study medication because either withdrew consent or were withdrawn from the study based on protocol violations.
726164|NCT02064387|This is a Phase1 study of antibody drug conjugate GSK2857916 in participants with relapsed/refractory multiple myeloma(MM) or non-hodgkin's lymphoma (NHL).The study was conducted in 2 parts-Part1(dose escalation) and Part2(dose expansion).The starting dose in Part1 was 0.03mg/kg GSK2857916 given once every three weeks; 1cycle=21 days for 16cycles.|A total of 79 participants were enrolled (38 participants in Part-1 and 41 participants in Part-2).
726165|NCT02064270||
726166|NCT02064231|The subject were recruited through the Danish Coloplast user data base.|"28 subjects were randomized. However 2 subject were wrongly randomized. 1 subject was allocated to test Test D in the First period,1 subject First tested Test A followed by Test D.
~Two subject discontinued the testing of the new test products collected data on own product.
~These factors disturb the participant flow chart."
726167|NCT02064205|"Recruitment lasted from May 2014 - August 2014. 121 subjects were planned for screening. 46 subjects met the inclusion criteria, 37 subjects did not show up, and 38 subjects had screening failures.
~The CRO that conducted the clinical trial was:
~QPS Netherlands B.V. Groningen The Netherlands"|In the study four test days were conducted, one weekly. Between test day there are six days of wash-out.
726168|NCT02064166||
726169|NCT02063880||
726170|NCT02063867|The Participant Flow section reflects numbers of hospitals that were enrolled in the intervention (the unit of enrollment and randomization was hospital), as well as the number of participants included in analysis, (the number of patient admissions from participating units in the enrolled hospitals), in each arm during the intervention period.|
726171|NCT02063854|Participants took part in the study at 67 investigative sites in Japan from 21 February 2014 to 19 November 2015.|Participants with a diagnosis of involutional osteoporosis were randomized at a ratio of 3:1:3:1:1:3:1 into 1 of 7 treatment groups: once-daily NE-58095 2.5 mg immediate release (IR) or once-monthly NE-58095 25 mg or 37.5 mg delayed release (DR) on awakening, after breakfast or 30 minutes following breakfast.
726172|NCT02063737||
726173|NCT02063724|Participants were enrolled October 2014 through June 2017 at Abramson Cancer Center of the University of Pennsylvania and Moffitt Cancer Center.|
726174|NCT02063698||
726175|NCT02063672||
726176|NCT02063659|Participants took part in the study at 31 investigative sites in Australia, Belgium, Canada, France, Germany, Israel, Netherlands, Spain, Sweden, United Kingdom, and the United States from 11 Mar 2014 to 29 Mar 2016.|Participants with Carcinoid Syndrome not adequately controlled by somatostatin analog (SSA) therapy were randomly assigned in a 1:1:1 ratio to receive placebo, 250 mg or 500 mg telotristat etiprate (LX1606) in the double-blind treatment period and were eligible to receive 500 mg telotristat etiprate in the open-label extension period.
726177|NCT02063516||
726178|NCT02063230||
726179|NCT02063217||
726180|NCT02063178||
726181|NCT02063087||
726182|NCT02063035||
726183|NCT02062905||
726184|NCT02062879||
726185|NCT02062801||A total of 710 participants met criteria for eligibility in the study. Of that total, 108 declined to participate in the study, and were excluded prior to random group assignment. This resulted in 602 total participants (301 for each of the intervention groups).
726186|NCT02062710||
726187|NCT02062658|Adult outpatients were recruited from the community starting March 2014 until March 2015.|No pre-assignment was done.
726263|NCT02057757||
726189|NCT02062632||5 were accrued but only 3 provided data. Since only 1 patient was accrued & completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) & only for placebo intervention.
726190|NCT02062580||
726191|NCT02062502||
726192|NCT02062450|"472 patients who underwent hip arthroplasty with a Dual Mobility Cup between September 2010 and December 2011, in the 5 participating centers, have been identified.
~379 out of them have been successfully reached by phone to be convoked for their 2-year postoperative follow-up visit. The other 93 patients were considered lost to follow-up."|Of the 379 contacted patients, 255 came to visit their surgeons for the 2-year follow-up. The other 124 who declined to visit were evaluated by phone for safety criteria.
726193|NCT02062437|All patients who received the same Total Hip Replacement system for primary hip replacement between July and October 2010 were contacted for study participation.|
726194|NCT02062398||
726195|NCT02062385|A total of 4173 participants were screened, 4040 were randomized, and 4037 received at least one dose of study vaccination.|
726196|NCT02062359||
726197|NCT02062294|This study was conducted between 09 July 2010 and 22 September 2011 and recruited participants from 3 sites in Switzerland.|A total of 14 participants who were CMV seronegative and had received a liver transplant from a CMV seropositive donor, received 900 mg Valganciclovir in this study.
726198|NCT02062177|140 consecutive outpatients were scheduled to undergo Upper Endoscopy (70 patients) or complete Colonoscopy (70 patients) from 17 th February 2014 to 5 th May 2014 in Endoscopy Unit of San Raffaele Hospital - Milan.|"Exclusion criteria were: significant systemic disease (ASA III-IV), allergic reactions to study drugs, chronic use of opioids, psychiatric disorders, pregnancy, difficult airways (Mallampati score >2), age <18 years.
~A gastroenterology attending fellow (GF), not directly involved in the procedure, provided sedation."
726199|NCT02062151||
726200|NCT02061969||
726201|NCT02061774||
726202|NCT02061748|A non-interventional study based on existing data was conducted. This is a retrospective database analysis to assess the safety and effectiveness of dabigatran compared to warfarin in patients diagnosed with non-valvular atrial fibrillation (NVAF) in the real-world setting using the Humana population.|Participant flow and demographic section is based on Pre-propensity score matching data however to analyze the outcome measures Post-propensity score matching data were used.
726203|NCT02061696||Thirty-nine patients enrolled in the study.
726204|NCT02061683||
726205|NCT02061592||128 of the 136 subjects were randomized. 8 subjects did not meet the eligibility criteria. 3 subjects were discontinued from the study. 12 subjects were excluded from analysis due to major protocol deviations. 113 subjects completed all study visits without a major protocol deviation.
726206|NCT02061540|The study was conducted in 8 centers in Great Britain, Canada, and the United States between 22 April 2014 and 12 February 2016.|A total of 37 participants were screened, of them 27 participants were enrolled in the study.
726207|NCT02061397||
726208|NCT02061358|This was a single center study performed in the United States. The study was completed with a total of 64 patients enrolled.|Each cohort was assigned 6 subjects who received the cohort's prescribed dose of UV-4B, along with 2 subjects in each cohort assigned to receive placebo.
726209|NCT02061280||
726210|NCT02061202|Recruitment began in February 2014, with first enrollment in March 2014, and last enrollment in October 2016|
726211|NCT02060903||
726212|NCT02060890||
726213|NCT02060838||
726214|NCT02060539|Study included 2 visits screening and fitting. Up to 50 existing lens wearers prescriptions from +20 to -20D spheres fitted. Participants evaluated at baseline/screening and lens dispensing visit with at least 1 other visit occurring at minium of 2 weeks lens wear.|
726215|NCT02060526||A total of 24 participants were screened, of them 21 participants were enrolled in the study.
726216|NCT02060461||
726217|NCT02060383|A total of 68 randomized evaluable participants with at least 8 weeks of randomized treatment without any rescue anti-diabetic medication was required. Approximately 79 participants were planned to be randomized.|249 participants were included in study & treated with pasireotide s.c. (59 with Cushing's disease) or pasireotide LAR (190 with acromegaly). Following pre-randomization period (up to 16 weeks), 81 participants were randomized to either incretin-based therapy or insulin (72 evaluable for the primary analysis) & 168 not qualified for randomization.
726218|NCT02060370|Sixty participants enrolled between August 2014 and March 2016. Participants recruited from The University of Texas MD Anderson Cancer Center, Cleveland Clinic Foundation, Fox Chase Cancer Center, and University of North Carolina Lineberger Cancer Center). All participants had confirmed treatment naive metastatic clear cell renal cell carcinoma.|One participant did not take the study medication due to declining mental health status before the first dose was initiated. Consequently, only 59 patients were included in the final analysis.
726219|NCT02060058|As protocol|As protocol
726220|NCT02059993|We recruited consecutive patients from outpatient and inpatient departments of Fuwai Hospital from January 2009 to June 2012. Patients were randomly assigned to either continuous positive airway pressure (CPAP) group or no CPAP therapy (control).|A total of 243 patients were screened between January 2009 and June 2012. Out of 97 (39.9%) patients diagnosed with obstructive sleep apnea (OSA), 5 subjects declined to participate in the study, and 9 subjects were excluded because of the following: apnea-hypopnea index (AHI) <15 (n = 8 patients) and severe heart failure (n = 1 patient).
726221|NCT02059980|This study enrolled individuals diagnosed with obsessive-compulsive disorder or trichotillomania at a mid-west university in the United States. The last participant completed in August 2017.|For this study, 258 individuals underwent online pre-screenings, and 83 participated in onsite full eligibility assessments. A total of 45 individuals met the study entry criteria, and were invited to the main study. Of them, 33 participants completed pre-training assessment and randomized into one of the two training conditions.
726222|NCT02059928||
726223|NCT02059902||36 patients were consented during the study period, 28 patients randomized and treated: 14 placebo vs. 14 lidocaine. Patients were excluded after signing consent for: arriving to the pre-op area wearing a Lidocaine patch, changes in surgery times, lack of grafting/surgery needs, and medical contraindications (such as lidocaine with metoprolol).
726225|NCT02059434|This study was conducted at 2 centres in the UK. In part 1 of the study, the first patient was screened in September 2013 and the last patient visit was in February 2014. In part 2 of the study, the first patient was screened in March 2014 and the last patient visit was in October 2014.|"This was a 2-part study.
~Part 1: incomplete crossover, single ascending dose study of 2 cohorts randomised to fixed sequences of LAS190792 or placebo in 3 treatment periods.
~Part 2: 5-way complete crossover, single dose study of LAS190792 (100/400 μg), placebo, or active controls (indacaterol 150 μg, tiotropium 18 μg) in 5 treatment periods."
726226|NCT02059408||
726227|NCT02059395||
726228|NCT02059291|This study consists of 4 study epochs. A total of 203 participants ((181randomized + 4 non-randomized open-label participants in Epoch 2) + (18 TRAPS rollover participants from ACZ885D2203 (NCT01242813) and ACZ885D2207M in Epoch 3)) have been enrolled into this study.|126 patients, randomized in Epoch 2, were not re-randomized in Epoch 3. These patients were switched to open-label (OL) treatment. Six patients discontinued OL treatment (1 due to physician decision, 1 due to subject/guardian decision, 3 due to lack of efficacy and 1 due to an adverse event).
726229|NCT02059278||
726230|NCT02059265|The study opened on 2/3/2014 and accrued 35 (28 treated and eligible) of a planned 62 patients. The study was closed on 8/10/2016, after evaluation of the stage 1 data.|Four patients were deemed ineligible and three patients were never treated; 28 patients were evaluable for efficacy and safety.
726231|NCT02059213||72 patients were enrolled to the trial. Seven patients did not have adequate tissue for testing retinoblastoma status. Two patients tested negative for retinoblastoma and one patient was found to have small cell metastasis and not adenocarcinoma. 62 patients were randomized.
726232|NCT02059187||
726233|NCT02059174|Male and female participants with Type I diabetes mellitus between the ages of 18 and 65 years (inclusive) were enrolled in this trial in 1 clinical site in the United States.|
726234|NCT02059161|Participants at least 18 years of age who have had Type 1 diabetes mellitus (T1DM) for at least one year prior to study start.|
726235|NCT02059148||
726236|NCT02059135||
726237|NCT02059070||
726238|NCT02059057||
726239|NCT02059005|Participants were recruited at Temple University Hospital between November 2015 and June 2016.|Participants were screened for eligibility using the AUDIT, DAST, and Mini-International Neuropsychiatric Interview (MINI) for substance use disorders.
726240|NCT02058992|Participants took part in the study at 557 investigative site in Japan from 30 July 2010 to 30 April 2013.|Participants with a historical diagnosis of insomnia who were facing difficulty in falling asleep in daily clinical practice were enrolled in single treatment group to receive ramelteon 8 milligram (mg).
726241|NCT02058966|Study staff screened 80 subjects over the phone between June 2014 to June 2016 at a clinical hospital in Portland, OR.|51 subjects failed the pre-screen primarily due to history of substance use disorder, time commitment conflicts, or unwilling to take methamphetamine. 14 of 29 subjects completed first randomization. Of the 29, 6 declined to participate, 4 did not meet inclusion criteria, 1 was excluded due to an adverse event, and 6 dropped out.
726242|NCT02058940||
726243|NCT02058849||
726244|NCT02058836||
726245|NCT02058628|This study was conducted from 21 February 2014 to 08 September 2014 across 11 centers in Germany. A total of 222 participants were enrolled.|Out of 222 enrolled participants, one was assessed as screening failure and thus, 221 participants were randomized with 111 allocated to Duac and 110 to Skinoren. Four randomized participants were not treated with any study drug and therefore the intent-to-treat population consisted of 217 participants.
726246|NCT02058589||Out of 265 subjects originally enrolled in the study, only 264 subjects received vaccination and were hence included in the Total Vaccinated Cohort.
726247|NCT02058563|A total of 996 subjects were enrolled and 994 were vaccinated. Of the 994 vaccinated subjects, 83 subjects from 2 US sites were excluded due to significant GCP concerns, resulting in 911 subjects in the Total vaccinated cohort considered for the analysis.|
726248|NCT02058537||
726249|NCT02058511||
726250|NCT02058498|Participants were enrolled at Mayo Clinic in Jacksonville, Florida. Data were collected from April 2014 to September 2014.|
726251|NCT02058368|A randomized, double-blind, parallel group trial to assess the effectiveness and safety of dutasteride (Dut) 0.5 milligram (mg) and tamsulosin (Tam) 0.2 mg combination compared to Tam 0.2 mg. The study consisted of a single-blind, placebo run-in, followed by a 2 year treatment. Eligible subjects were randomized to Dut + Tam or Dut placebo + Tam|Six hundred and fifty moderate to severe benign prostatic hyperplasia (BPH) subjects were screened with 607 participants receiving as least one dose of the study medication (China 243, Japan 135, Korea 181, Taiwan 48). Five hundred and twelve subjects completed the study with 95 subjects withdrawn.
726252|NCT02058290||
726253|NCT02058251||
726254|NCT02058160|The study was conducted at 236 centers in 18 countries. A total of 1930 participants were screened between January 27, 2014 and October 15, 2014. 912 participants were not eligible for run-in-phase mainly due to glycated hemoglobin (HbA1c) value being out of the protocol defined range.|After screening phase, 1018 participants entered 6 week run-in phase during which participants were switched (if necessary) to insulin glargine and dose was titrated/stabilized, any oral anti-diabetic drugs (OAD) other than metformin were stopped. 282 participants were run-in failures and 736 were randomized in 1:1(FRC:insulin glargine arms) ratio.
726255|NCT02058147|The study was conducted at 240 centers in 23 countries. A total of 2457 participants were screened between February 12, 2014 and September 16, 2014. 978 participants were not eligible for run-in mainly due to glycosylated hemoglobin (HbA1c) value at screening visit being out of the protocol defined range.|After 2 weeks screening period, 1479 participants underwent 4-week run-in period. 309 participants were run-in failures. A total of 1170 participants were randomized in 2:2:1 to insulin glargine/lixisenatide, insulin glargine and lixisenatide arms respectively in open-label treatment period.
726256|NCT02058108|This study was conducted in 20 centers in 7 countries: Bulgaria (2), Greece (1), Israel (2), Republic of Korea (1), Romania (5), Turkey (4) and Ukraine (5 sites).|Patients were stratified by age group (2 to < 6 years, 6 to <12 years and 12 to <18 years) and HBV DNA level (low and high). At the baseline visit, eligible patients were randomized in a 24-week double blind period to telbivudine or placebo in a ratio 5:1. At Week 24 (visit 6), all patients were unblinded and HBV DNA level were assessed.
726264|NCT02057692|Study was conducted at 13 study centers in the United States and Canada, between 24 November 2014 (first participant first visit) and 16 November 2016 (last participant last visit).|Overall, 37 participants were enrolled to dose escalation phase started with 14 microgram per kilogram per day (mcg/kg/day) per week on Week 1 up to 280 mcg/kg/day for a maximum up to 5 weeks, until they reached the planned stable dose of 70, 140 and 280 mcg/kg/day and continued up to Week 13.
726265|NCT02057640||
726266|NCT02057575||
726267|NCT02057549||
726268|NCT02057523||
726269|NCT02057458||
726270|NCT02057406||
726271|NCT02057393||
726272|NCT02057276||After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.
726273|NCT02057250|The study was conducted at 53 centers in 6 countries. A total of 419 participants were screened between 18 March 2014 and 14 October 2014, out of which 217 participants were enrolled and treated.|Participants were randomized in 1:1:1:1 ratio to Sarilumab 150 mg administered by auto-injector device (AID) or prefilled syringe (PFS) or Sarilumab 200 mg administered by AID or PFS. Participants who completed 12-week AID assessment phase, were treated in open-label extension phase for 52 weeks.
726274|NCT02057237||
726275|NCT02057198||
726276|NCT02057081||One participant was consented but their partner did not consent.
726277|NCT02057068|Recruitment for the intervention occurred between 2014 and 2016. Participants were recruited from the Geriatrics Clinic, the CVNR Caregiver Registry and by referrals from Social Workers and Primary Care.|Participants were excluded from the study if both members of the dyad reported sleeping well (no sleep problems, high sleep quality) during baseline interview and/or had sleep efficiency of 85% or greater as measured by actigraphy during baseline week. Randomization occurred following baseline. Consented=102; Randomization=96.
726278|NCT02057042||
726279|NCT02056834||
726280|NCT02056652||
726281|NCT02056639||
726282|NCT02056626||
726283|NCT02056431||
726284|NCT02056392||
726285|NCT02056340||
726286|NCT02056301||
726287|NCT02056171|Six participants were enrolled over 22 months between March 2015 and December 2016. The first participant was enrolled in March 2015 and the last participant was enrolled in December 2015.|
726288|NCT02055976||
726289|NCT02055898||
726290|NCT02055820|At start the trial had a randomised-controlled component, until July 2016 once the arm B (Gazyva) got closed following the publication of results of another trial. Since July 2016, the trial was single-arm, not randomised anymore, and kept including patients in only 1 arm (Arm A, rituximab).|The data reported for participant flow is based on safety population, which includes all participants who received at least one dose of study medication.
726291|NCT02055638||One additional subject was enrolled than planned, due to timing of screening and notification to sites of ceasing planned enrollment.
726292|NCT02055547|Participants were recruited at one clinical site in Belgium.|"An optional Panel G in Part 2 per protocol did not occur.
~Period-level data were not collected for each treatment sequence."
726293|NCT02055430||
726294|NCT02055404|Participants were recruited from 1 US study center.|This reporting group includes all enrolled participants.
726295|NCT02055365||
726296|NCT02055352||
726297|NCT02055118|Study was conducted at 9 centers in Australia, Canada, France, Mexico, Spain, the United Kingdom and the United States between 24 Mar 2014 (first participant first visit) and 28 Sep 2017 (last participant last visit).|Overall, 103 participants were screened, of them 54 participants failed to meet the randomization and remaining 49 participants were randomized to receive either IT treatment or No IT treatment in pivotal study. A total of 9 participants were enrolled into the substudy.
726298|NCT02055053||
726299|NCT02054910||
726300|NCT02054897|Out of 87 sites, selected for recruitment, 72 sites in 8 countries randomised subjects: Canada: 7 sites; Italy: 6 sites; Japan: 5 sites; Mexico: 2 sites; Russian Federation: 8 sites; South Africa: 8 sites; United Kingdom: 4 sites; United States: 32 sites.|
726301|NCT02054754||
726302|NCT02054715||
726303|NCT02054702|The trial was conducted in 97 participants at 19 trial sites in United States.|The trial consisted of a 2- to 14-day screening phase, a 6-week treatment phase, and a 30-day follow-up phase.
726304|NCT02054572|This study was conducted at a single center in the United States from 07 February 2014 to 15 August 2014.|
726305|NCT02054520||The enrollment and treatment phase of this trial was terminated early, but the FDA required 15 year long term follow-up for gene therapy is still ongoing.
726306|NCT02054481||Participant flow shows disposition at the end of treatment.
726307|NCT02054338||
726308|NCT02054325||Some patients (n=6) were withdrawn because did not appear at the previous scheduled appointments, and were replaced for new ones. In order to avoid loss of individuals we have decided to include 6 more patients.
726309|NCT02054156||
726310|NCT02054130|The study was conducted from 19Dec2013 to 01Mar2017 across 12 countries (United States, Slovakia, Bulgaria, Czech Republic, Hungary, Israel, Japan, Latvia, Lithuania, Serbia, South Africa, and Ukraine). A total of 918 participants were recruited in the study.|Of 918 participants, 334 were considered screen failures and 584 participants were randomized. Of which, all populations excluded 34 participants from one site due to non-compliance of the principles of Good Clinical Practice.
726311|NCT02053753|This study was conducted at 2 centers in the United States.|Participants were randomized in a 1:1 ratio to receive a single 120-mg dose of denosumab either as a 1.7 mL single injection of 70 mg/mL denosumab produced using the new CP4 process or as a 1.7 mL single injection of 70 mg/mL denosumab produced from the current CP2 process.
726312|NCT02053610|787 patients were enrolled in the study. Following a 6 patient safety run-in prior to randomization, 781 patients were randomized.|589 patients were randomized to 1 of 3 treatment groups in 2:2:1 ratio: GClb (n=238), RClb (n=233) or Clb (n=118) in Stage 1 and an additional 192 randomized to GClb or RClb in Stage 2. Stage 1 was divided for analysis into: Stage 1a [NCT01010061] and Stage 1b [NCT01998880]. 663 participants were included in the Stage 2 Analysis reported here.
746411|NCT00833794||
726313|NCT02053493|All patients admitted to the participating HFN centers with signs and symptoms suggestive of HFpEF will be screened including their ability to wear the accelerometer belt. Patients meeting eligibility criteria will be approached regarding participation in this study.|All subjects who fulfill all the inclusion criteria and none of the exclusion criteria will undergo the baseline studies and then be randomized.
726314|NCT02053376||
726315|NCT02053259||
726316|NCT02053168||Of 33 subjects enrolled, 8 were not treated with the study device: a contraindication to the placement of mesh was present in 4 subjects; complete removal of existing mesh from a prior hernia repair (in the same affected area) was not possible in 3 subjects; and 1 subject had an active or latent systemic infection.
726317|NCT02052895||
726318|NCT02052752|Participants were recruited at a clinical site in USA|A total of 90 participants were randomized across the three treatment groups.
726319|NCT02052661||301 subjects were enrolled in the study but one subject was withdrawn before any study procedure.
726320|NCT02052635|This study was conducted in the USA. While 17 sites were activated, 9 sites enrolled patients, and only 7 sites successfully randomised patients. There were 34 patients screened, 21 screen failures and 13 randomised patients from 03 September 2014 and 20 April 2015. The study was terminated due to recruitment challenges and low enrolment concerns.|
726321|NCT02052596|Not all subjects who were enrolled started the study due to elimination from statistical analyses or no vaccination received.|"For one subject, the reason for withdrawal was incorrectly entered into the eCRF as lost due to Crohn's disease. The subject withdrew from the study due to a combination of irritable bowel syndrome and time constraints associated with employment. This information was clarified after database freeze."
726322|NCT02052544|"FPI: Jul 2012; LPO May 2013
~All three centers were hospitals (medical clinics) with certified laboratory."|Plasma from subjects treated with any other anticoagulants other than UFH. Plasma from subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks.
726323|NCT02052466||
726324|NCT02052440|Recruitment and enrollment began March 1 2014 and terminated Jan 1 2017. Patients were enrolled after admission to general medical services at Denver Health Hospital.|Patients could be excluded if found to be pregnant prior to being assigned to study arm.
726325|NCT02052414||
726326|NCT02052141|The study was conducted in 10 study centers in the United States, European Union, Mexico, and Israel between 20 March 2014 (first participant first visit) and 04 May 2017 (last participant last visit).|A total of 16 participants were screened and of them, 12 were enrolled into the baseline observational period (12 weeks) and were randomized to receive the treatment in sequence A-B and B-A during this crossover study without a washout period.
726327|NCT02052011|This study was conducted from June, 2014-November, 2015 at the Yale New Haven Hospital Chest Pain Center, an ED observation unit that treats low-moderate cardiac risk patients.|
726328|NCT02051816||
726329|NCT02051790||
726330|NCT02051764|Enrolled subjects who had previously undergone flortaucipir PET (positron emission tomography) scans in other Avid-sponsored (NCT04474405 and NCT01992380) and non-Avid protocols and brought back to the clinic a minimum of 6 months after the initial flortaucipir PET scan for cognitive testing and an additional flortaucipir scan.|
726331|NCT02051686||
726332|NCT02051595||
726333|NCT02051452||
726334|NCT02051426||
726335|NCT02051335|Participants took part in the study at 1 investigative site in the United Kingdom from 16 January 2014 to 17 May 2014.|Participants with a diagnosis of Alzeimer's disease were enrolled equally in a 4 period, 4 treatment crossover study. Treatment A: Placebo, Treatment B: Donepezil, Treatment C: Roflumilast and Treatment D: Roflumilast + Donepezil. All participants received scopolamine on Day 1 of each treatment period.
726336|NCT02051296||
726337|NCT02050919||
726338|NCT02050841||
726339|NCT02050334||
726340|NCT02050321||
726341|NCT02050308||
726342|NCT02050048||
726343|NCT02049957|Participants took part in the study at 40 investigative sites in Belgium, France and the United States from 13 February 2014 to 03 July 2018.|Postmenopausal women with estrogen receptor positive/human epidermal growth factor receptor-2 negative advanced/metastatic breast cancer who progressed with everolimus (everolimus sensitive-achieved CR/PR of any duration/stable disease for ≥6 months; resistant-without CR/PR/SD < 6 months) were enrolled to receive MLN0128+exemestane/fulvestrant.
726344|NCT02049931||
726345|NCT02049814|Participants took part in the study at 22 investigative sites in China from 09 May 2014 to 28 June 2016.|Participants with a diagnosis of type 2 diabetes mellitus (T2DM) were enrolled in 1:1 to receive voglibose combined with metformin or acarbose combined with metformin.
726346|NCT02049749||
726347|NCT02049502||
726348|NCT02049476||
726349|NCT02049450||Approximately 30 patients were planned to be enrolled in the study. 30 patients were analyzed in the full analysis, PK, and safety sets; 27 patients were analyzed in the per-protocol set.
726350|NCT02049437||
726351|NCT02049385||
726352|NCT02049307||
726353|NCT02049151|First/last subject(informed consent): 21 Mar 2014/11 Sep 2014. Study completion date: 02 Jul 2015.|50 subjects were screened for eligibility; 15 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria) and 35 subjects were randomized. Three subjects were randomized but were not treated.
726354|NCT02048904|Total enrollment at time of termination of study was 142 participants. However, study was terminated during the enrollment period due to difficulties at the study site. All data collected from participants remains untabulated and no analysis is expected.|65 participants had completed study by time of study termination.
726355|NCT02048891||
726356|NCT02048878||
726357|NCT02048722|The study was opened for enrollment March 12, 2014 with the first patient starting treatment June 13, 2014. A total of 31 patients were treated under the protocol. The study was permanently suspended to further enrollment August 5, 2019.|
726358|NCT02048670||
726359|NCT02048241||
726360|NCT02048072|First patient in: 21.08.2013 Last patient out: 16.06.2015|
726361|NCT02047981||
746412|NCT00833781||
726362|NCT02047929|All practices were recruited and randomized by May 2014.|All practices were randomized in the study. Since the intervention was practice wide, individual patients were not required to be enrolled or consented.
726363|NCT02047903|This is a non-interventional study (NIS) in real life clinical setting, in which responses were determined by using Response Evaluation Criteria in Solid Tumors (RECIST)/World Health Organization (WHO)/clinical evidence as investigators deemed appropriate.|Data source for this study were medical records usually collected during routine clinical practice other than study-specific questionnaires. Data collection was performed between March 24, 2014 and March 14, 2019.
726364|NCT02047747||
726365|NCT02047643||
726366|NCT02047500||
726367|NCT02047344|Unselected KRAS-positive and KRAS-negative patients with stage IV (including pleural effusion) non squamous NSCLC and radiologically-confirmed disease progression following greater than or equal to two, but less than or equal to four, prior lines of systemic anti cancer therapy.|Written informed consent was obtained from all patients before initiating screening. The screening period was up to 42 days in duration (Days 42 to 1) for K-Ras testing result, if no history k-Ras result.
726368|NCT02047305||
726369|NCT02047253|Protocol Open to Accrual: April 2014, Primary Completion Date: June 2017 and Study Completion Date: July 14, 2017. Recruitment location: University of Alabama at Birmingham (UAB) Comprehensive Cancer Center, Birmingham; Tulane University, New Orleans; Medical Center of Central Georgia, Macon, Georgia, Dana Farber Cancer Institute, Boston.|
726370|NCT02047227|The study was conducted at 101 sites in 15 countries.|
726371|NCT02047110||The trial had a double blind (DB) treatment period up to Week 24, an Escape treatment period up to Week 40, and an open-label-extension (OLE) treatment period that lasted 26 weeks after OLE entry. Each of the treatment periods was followed by a 24- week post-treatment follow-up period.
726372|NCT02047045||
726373|NCT02047032||
726374|NCT02046993|recruitment of eligible subjects from January to December 2014 at a primary care clinic in Hong Kong|
726375|NCT02046980||217 patients enrolled in the study but 8 retracted their agreements.
726376|NCT02046941||
726377|NCT02046902|Between May 2014 and December 2016, patients were recruited from 2 percutaneous coronary intervention (PCI) centers, Saint Luke's Mid America Heart Institute (MAHI) and Truman Medical Center (TMC), following institutional review board (IRB) approval at each site.|
726378|NCT02046863||
726379|NCT02046772||
726380|NCT02046616||One hundred thirty-three participants entered the 24-week Treatment Period. Those who completed treatment entered the Follow-Up (FU) Period for an additional 8 weeks.
726381|NCT02046603||A total of 162 participants were enrolled. One participant who did not receive a dose of tocilizumab was excluded from the full analysis set (FAS) and the results are reported for 161 participants.
726382|NCT02046564||
726383|NCT02046525||
726384|NCT02046382||
726385|NCT02046369||
726386|NCT02046317||
726387|NCT02046265|Participants were recruited from 2 sites, both with federally-supported family planning programs.|All participants completed a baseline survey prior to randomization.
726388|NCT02046226||The randomization of subjects to either of the two treatments (OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care) in this study was not indicated on each of the case report forms of the seven subjects enrolled.
726389|NCT02046200||
726390|NCT02046148|Subjects were enrolled in United States.|
726391|NCT02046135||
726392|NCT02046122||1 subject was a screen failure and 1 subject withdrew prior to starting study.
726393|NCT02046070|Participants took part in the study at 23 investigative sites in Australia, Greece, Poland, Sweden and the United States from 05 March 2014 to 29 June 2018.|Participants with NDMM were enrolled in 1 of 2 arms to receive 4.0 mg ixazomib in combination with 300 or 400 mg cyclophosphamide and 40 mg dexamethasone (CCd); participants with RRMM were enrolled in 1 arm to receive ixazomib 4.0 mg CCd. All arms included a safety lead-in cohort for pharmacokinetics (PK) analysis.
726394|NCT02046005||
726395|NCT02045979|In this trial 324 healthy subjects were randomized into 3 arms.|All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not randomised to trial treatment if any one of the specific entry criteria were violated.
726396|NCT02045875||
726397|NCT02045862|"Participants who had symptoms of wet overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled in 251 centers globally. A majority of the participants were recruited from participants who enrolled and completed studies 178-CL-101 (NCT01972841) or 905-EC-012 (NCT01908829)."|A total of 2084 participants were screened, 2063 participants received placebo run-in treatment and 1829 participants were randomized into 1 of 3 treatment arms in a 1:1:4 ratio in the 52-week double-blind treatment period. Randomization was stratified by sex, age group (< 65 years, ≥ 65 years) and geographic region.
726398|NCT02045836||
726399|NCT02045797|This study was conducted at 13 centers in the United States from 24 March 2014 to 22 July 2015.|A total of 126 participants were randomly assigned to study treatment (all randomized population). A total of 122 participants, who received study treatment, were included in the Modified Intent-to-Treat population (mITT) and safety populations. The mITT population is used in overall study numbers and demographic information.
726400|NCT02045732|This study was a Phase 1b, randomized, multi-center, double-blind, sponsor-open, placebo controlled study to evaluate multiple ascending doses of PF-06342674 in participants with Multiple Sclerosis (MS). Up to 60 participants were planned to be enrolled. However, only 4 participants were randomized due to the early termination of the study.|Participants were screened within 45 days prior to the first administration of the study drug to confirm that they met the participant inclusion criteria for the study.
726401|NCT02045511||
726402|NCT02045433||
726403|NCT02045277||
726404|NCT02045264||
726405|NCT02045238||
726406|NCT02045212||
726407|NCT02045108||
744973|NCT00908141|Patients recruited from local medical clinic from June 2006 to August 2010.|
726408|NCT02045095|Participants took part in the study at 7 investigative sites in the United States from 31 January 2014 to 09 November 2016.|Participants with diagnosis of advanced malignant solid tumors were enrolled in Schedule A of dose escalation phase to receive TAK-243 (MLN7243). The study was terminated prior to start of Schedule B of dose escalation phase and planned expansion because of realignment of the sponsor's pipeline program.
726409|NCT02044991|Recruitment for this trial began in May 2015 and ended in May 2016 (12 months). The trial was terminated in February 2017 due to poor recruitment|
726410|NCT02044874||
726411|NCT02044848|Only adult patients were enrolled (no pediatrics as planned) and no one completed the planned treatment period.|
726412|NCT02044822|Participants were enrolled at study sites in Australia, Europe, and the United States. The first participant was screened on 06 August 2014. The last study visit occurred on 17 May 2016.|130 participants were screened.
726413|NCT02044796||
726414|NCT02044510||
726415|NCT02044458||
726416|NCT02044419||
726417|NCT02044393||
726418|NCT02044380|This open-label, multicenter, single-arm trial evaluated the safety & tolerability of the investigational drug afatinib.All entered patients in this trial (i.e., patients that had been treated with the trial medication) received continuous treatment of afatinib in the absence of disease progression or meeting any other trial withdrawal criteria.|The planned trial end date was 10 February 2016. On the end date, all patients on treatment that met the approved label indication were planned to be switched to commercially available afatinib.
726419|NCT02044367||
726420|NCT02044302||
726421|NCT02044159||
726422|NCT02044094||A total of 342 subjects signed an informed consent with 39 subjects being enrolled and randomized to the sequential order of hydromorphone challenges to be received. The most common reason for not being randomized was due to the study exclusion criteria being met.
726423|NCT02043938||
726424|NCT02043860|1 ineligible|
726425|NCT02043808|Existing data cohort design with propensity score matching (PSM). Variables included in the final propensity score model were: age, gender index year, baseline CHADS(2) score, baseline CHA(2)DS(2)-VASc score, baseline HAS-BLED score, baseline use of several medications and presence of several baseline co-morbidities.|
726426|NCT02043782||
726427|NCT02043704||
726428|NCT02043678|Study was conducted at multiple centers in 19 countries between 30 March 2014 (first participant first visit) and 15 February 2018 (data cut-off date).|Overall, 1144 participants were screened. Of them, 338 participants did not complete screening, 806 participants were randomized to treatment and 786 participants received study treatment.
726429|NCT02043652||
726430|NCT02043574||
726431|NCT02043548|Adult refractory dermatomyositis and polymyositis|
726432|NCT02043509||
726433|NCT02043379||
726434|NCT02043366|From February 2014 to June 2015, patients were recruited and estimated for eligibility|Exclusion criteria: coronary heart disease, bronchial asthma, cardiac, lung, hepatic and renal insufficiency, severe hypertension, diabetes mellitus, psychiatric disease, obesity, a history of chronic pain, a history of alcohol or opioid abuse, pregnancy, allergy and contraindication to study drugs, a history of gastrointestinal disease
726435|NCT02043301||Seventy-five (75) participants were enrolled and randomized in a 1:1:1 ratio to receive a single dose of Treatment A (PF-04950615 [hereafter referred to as bococizumab] 150 mg subcutaneously [SC] to the abdomen), Treatment B (bococizumab 150 mg SC to the thigh), or Treatment C (bococizumab 150 mg SC to the upper arm).
726436|NCT02043197||
726437|NCT02043145||
726438|NCT02043132||116 participants were consented; 2 were lost to follow-up and 12 were screen failures. These 14 participants were excluded from the overall data analysis, therefore 102 completed participants were analyzed.
726439|NCT02043015|Participants were recruited in Cape Town, South Africa between February 2015 and September 2015. Each participant was followed for one year.|To obtain the target enrollment of 80 HIV-negative and 20 HIV-positive participants, additional HIV-positive persons consented to participate but were not prospectively followed after the baseline visit. Fifteen participants were study stopped after baseline and not eligible for prospective follow-up to reach the target enrollment numbers.
726440|NCT02042950||Out of 6 enrolled participants 2 failed screening.
726441|NCT02042924||
726442|NCT02042911||
726443|NCT02042872||
726444|NCT02042534||
726445|NCT02042443||
726446|NCT02042404|Flyers approved by WIRB for subject recruitment. Also referrals from local audiology clinics and otologists.|"The first five (5) enrolled will be part of a pilot phase of the study to work out the process flow and training of the centers and participants, called Roll-in Cohort."
726447|NCT02042274||
726448|NCT02042183||The two weeks between screening and treatment were used as a washout period for disallowed medications.
726449|NCT02042131||
726450|NCT02042014|8 participants entered this study after completing the CQTI571A2301E1 study. All 8 participants discontinued study prematurely.|
726451|NCT02041962||A total of 280 participants were consented and enrolled to participate. Of those 280 participants, only 238 completed the baseline survey and were randomized.
726452|NCT02041702||
726453|NCT02041533||1325 participants were enrolled; 541 were randomized to a treatment group; 530 were treated. Participants were randomized but not treated due to disease progression (n=2), withdrawal of consent (n=5), or they no longer met study criteria (n=4)
726454|NCT02041520||
726455|NCT02041377||
726456|NCT02041325||
726457|NCT02041286||
726458|NCT02041221||
726459|NCT02041104||In total, 81 participants were invited to trial trough national programme for metabolic disorder prevention and with help of family doctors. 30 participants were excluded due to personal reasons or because they did not meet inclusion criteria.
726460|NCT02041091||Participants who complete the Treatment Period will have the option of participating in the Optional Safety Extension Period through Week 52.
737183|NCT01332968||Eleven patients withdrew from the study after randomization but prior to receiving study treatment.
726461|NCT02040870|Approximately 100 patients were planned to be enrolled, and 103 patients were actually enrolled and analyzed.|Not Completed means that the participants discontinued from the treatment phase
726462|NCT02040857||
726463|NCT02040844||
726464|NCT02040805|Recruitment occurred during April 2014 through February 2016. Participants were individuals with Hoarding Disorder recruited primarily through the Mental Health Association - San Francisco and flyers in the bay area (e.g. community center boards, coffee shops, laundry mats, libraries).|
726465|NCT02040792||One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK (GlaxoSmithKline) study with another investigational agent at the same time as their participation in this study.
726466|NCT02040779|For this study, 47 sites were activated and screened at least 1 patient, 44 sites screened at least 1 patient who entered the run-in period, and 43 sites randomly assigned a patient. Overall, 273 patients were randomly assigned to treatment|
726467|NCT02040766|Patients were screened at 123 centers in Croatia, Mexico, Poland, Ukraine, and the United States. The intent-to-treat (ITT) population included all randomly assigned patients|Patients were randomly assigned to treatment through a qualified randomization service provider. This system was used to ensure a balance across treatment groups, within each stratum
726468|NCT02040623||
726469|NCT02040584|Patients enrolled were 217, patients in the safety population were 215, and patients in the ITT population were 211.|The intention-to-treat population (ITT) that was used for all efficacy analyses included all randomised patients who had received at least one dose of the study medication (safety population) and had at least one assessment subsequent to the randomisation visit for determining the primary efficacy endpoint.
726470|NCT02040532|Women were recruited from the Boston area and enrolled at either the Massachusetts General Hospital Center for Women's Mental Health or the Brigham and Women's Hospital Women's Hormones and Aging Research Program.|
726471|NCT02040428|Subjects were recruited from January 13, 2014 through September 23, 2015 at hospitals and medical centers throughout the United States, United Kingdom, Belgium, Japan and Australia.|One subject was randomized to EVARREST, but instead received TachoSil; and analyzed in EVARREST ITT set and in TachoSil group for Safety set. Therefore, Safety set consists of 75 subjects in EVARREST arm and 81 subjects in TachoSil arm, while the ITT set consists of 76 subjects in EVARREST arm and 80 subjects in TachoSil arm.
726472|NCT02040259|The Trevo Retriever Registry was a prospective, open-label, consecutive enrollment, multi-center international registry designed to enroll up to 2,000 subjects at up to 100 clinical sites worldwide.|
726473|NCT02040116||
726474|NCT02040077||Although the study expected to enroll and randomize 75 participants, an additional participant was randomized into the study - resulting in a final overall sample of 76 randomized participants.
726475|NCT02039947||"A subject was considered to have completed the study if the subject died during the study treatment or follow-up period or (for subject in Cohort A) had at least 3 years follow-up from the date of first dose of study treatment at the end of the study.
~All subjects achieved that definition and then the study ended."
726476|NCT02039908|Participants were recruited in 4 annual cohorts from 2013-2016. Participants could be referred by schools, physicians, or community advertisement; interested parents completed phone screens and a clinic intake to assess inclusionary and exclusionary criteria.|Because all participants were required to be enrolled in a Summer Treatment Program, some participants withdrew after consenting because they were unable to make the time commitment to the 8-week summer program.
726477|NCT02039856|Random samples of women Veteran clinic users (patient surveys) and census of each VAMC's primary care and women's health providers and staff in PACT and WH-PACT (web surveys) at 12 participating VAMCs recruited through the WH Practice Based Research Network|
726478|NCT02039817|This was an open-label, multicenter, parallel-group study to compare the PK and PD of IDN 6556 following a single 50 mg oral dose of IDN-6556 in subjects with severe renal impairment and matched subjects with normal renal function (healthy volunteers).|In total, 16 subjects were enrolled and dosed (8 subjects with severe renal impairment, and 8 healthy volunteers) with one 50mg dose of IDN-6556.
726479|NCT02039778||
726480|NCT02039726|A total of 367 participants who met the inclusion and none of the exclusion criteria were randomized (intent-to-treat population); 335 received study drug (safety analysis set).|Prior to randomization, the investigator was required to pre-select 1 of the 3 salvage chemotherapy regimens for each participant. Randomization was stratified by response to prior therapy (relapsed in ≤6 months [with or without HSCT] or refractory) and pre-selected salvage chemotherapy (high or low intensity chemotherapy) for all participants.
726481|NCT02039687||
726482|NCT02039674|This results disclosure is based on efficacy data cutoff dates of 08-Aug-2016 for Cohorts C & G, & 07-Nov-2016 for Cohorts A, B, D, E, F & H, & a safety data cutoff date of 07-Nov-2016. As of 07-Nov-2016, 96 participants were still ongoing in the study.|
726483|NCT02039505|Participants took part in the study at 86 investigative sites in Japan from 04 February 2014 to 28 June 2018.|Participants with moderate to severe ulcerative colitis (UC) were enrolled. 292 participants enrolled in induction phase, 109 participants entered maintenance phase and 259 participants entered open-label cohort and received placebo or vedolizumab 300 mg. Open-label cohort occurred between Week 10 and Week 154 through study with maximum 94 weeks.
726484|NCT02039427|This study was conducted Yeungnam University Hospital in South korea from Oct. 2013 to Oct. 2015. One hundred and ninety - two female adults aged between 20 and 65 years, ASA physical status I or II scheduled for elective primary thyroidectomy under general anesthesia were enrolled.|Patients with a airway problem, recent upper respiratory tract infection, obese, inflammation or hemorrhage in the upper gastrointestinal tract, use of NSAID or steroid medication, allergy to the general anesthetic used in this study were excluded.
726485|NCT02039414||
726486|NCT02039375||
726487|NCT02039219||
726488|NCT02039115||
726489|NCT02038959|Individuals with Parkinson disease were recruited and enrolled remotely and sent educational materials about Parkinson disease created by the National Parkinson Foundation. Recruitment for the study began in February 2014.|272 individuals were referred to 18 sites to be consented. Two hundred ten individuals with Parkinson disease enrolled in the study, and 195 were eventually randomized.
744974|NCT00908128||
744975|NCT00908115||
726490|NCT02038946||116 participants were enrolled; 92 received study treatment. Participants were enrolled but not treated because they no longer met study criteria (n=20), withdrew consent (n=1), or for other reasons (n=3).
726491|NCT02038933||161 participants were enrolled; 121 participants entered the treatment period. Participants were enrolled but not treated due to Adverse Events (n=2), withdrawal of consent (n=2), death (n=2), or they no longer met study criteria (n=34).
726492|NCT02038920|Participants took part in the study at 77 investigative sites in Japan from 28 Jan 2014 to 21 May 2019.|Participants with moderate to severe Crohn's disease were enrolled. 157 participants enrolled in induction phase, 41 participants entered maintenance phase and 134 participants entered open-label cohort and received placebo or vedolizumab 300 mg. Open-label cohort occurred between Week 10 and 154 through study with maximum of 94 weeks of treatment.
726493|NCT02038907|Participants took part in the study at 2 investigative sites in Belgium from 28 March 2014 (first participants signed the informed consent form) to 19 June 2015.|Healthy volunteers were enrolled equally in 1 of 14 unique formulation treatment groups: 11 formulation arms received 1 dose and 3 formulation arms received 2 doses.
726494|NCT02038894||
726495|NCT02038881|Subjects were screened and enrolled at 12 sites in the US|
726496|NCT02038829||Eligible subjects will be randomized to one of 12 treatment sequences. There will be a minimum of a 7-day washout period between each treatment visit. At each visit, subjects will receive one dose of study medication according to the sequence assigned.
726497|NCT02038790||Thirty nine (39) subjects were screened and thirty three (33) subjects were enrolled in the study.
726498|NCT02038764||A total of 37 participants were assigned to study treatment (placebo: 7 subjects; PF-06342674: 30 subjects)
726499|NCT02038647|Participants took part in the study at 54 investigative sites in the United States, Canada, European Union (Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland and Spain) from 12 May 2014 to 10 July 2017. Data cutoff for the primary analysis was 3 January 2016.|Participants with a diagnosis of Small Cell Lung Cancer (SCLC) were enrolled in 1 of 2 treatment groups: alisertib + paclitaxel or placebo + paclitaxel arm group.
726500|NCT02038569||
726501|NCT02038543|Subjects were enrolled at Mayo Clinic in Rochester, Minnesota.|
726502|NCT02038218|Study completed - Tulane Medical Center (2017-19), Detroit Research Center (Lansing, Detroit and Owasso) 2017-19, Mt Sinai Medical Center, NYNY, 2014-18 and Ochsner Medical Centers (New Orleans, 2017-19.|Patients with cancer involving the CNS were treated with intravenous DM-CHOC-PEN. The drug is metabolized by the liver. Abnormal neurological and hepatic values excluded the patients from treatments. If the patients were on steroids, this also excluded treatments. Steroids initiate the break down of DM-CHOC-PEN.
726503|NCT02038179||Participants completed a 2-4 week placebo run-in prior to assignment to study arm.
726504|NCT02038153||
726505|NCT02038075|Participants were identified during weekly behavioral health treatment team meetings and daily emergency department reports. All soldiers admitted to inpatient psychiatric hospitalization for suicidal ideation or for a suicide attempt from January 2011 to September 2012 were referred upon discharge for determination of eligibility.|30 of 206 referred Soldiers were excluded (15 due to planned move in next 6 months, 15 refused). 24 of 176 consenting to participate were excluded (22 ineligible, 2 dropped before randomization).
726506|NCT02038049|This study was conducted in 5 centers in 3 countries: Czech Republic (1), Ukraine (2 sites) and USA (2 sites).|The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.
726507|NCT02038023|Standard referrals from obstetricians and gynecologists|Oral iron intolerance plus iron deficiency anemia as defined by a serum ferritin of <20 ng/mL or transferrin saturation of <19% in the 2nd or 3rd trimester plus the ACOG guidelines of <10/.5 g/dL and 11.0 g/dl respectively. 73/74 enrolled received the planned dose.
726508|NCT02038010|The study opened for accrual on February 26, 2014 with an accrual goal of up to 28 patients. The first patient started treatment May 21 2014. The study was designed as a 3 + 3 escalation. 6 patients were enrolled in Cohort 1 and 11 patients enrolled in Cohort -1. The study closed February 12, 2016 with accrual for the study design having been met.|
726509|NCT02037984|Healthy adults and infants were recruited and enrolled at 26 study sites in the United States. Each of the adult participants completed the study prior to enrollment of the infant participants.|
726510|NCT02037893||
726511|NCT02037776||
726512|NCT02037607||
726513|NCT02037568|Caregivers and their Allo-HSCT patients were recruited consecutively between 3/2014 and 11/2016 during pre-transplant screening admitted for treatment to two transplant programs in the Denver metro area for participation in this study: a university-based NCI-designated Comprehensive Cancer Center and a community-based cancer center.|159 patient-caregiver dyads were consented (318 participants).
726514|NCT02037555||
726515|NCT02037477|Participants took part in the study at 1 investigative site in Japan from 3 February 2014 to 27 March 2014.|"A total of 56 participants signed the informed consent form. 20 participants were enrolled and received the study drug. The primary reason for ineligibility to receive the study drug was did not meet entrance criteria for 16 subjects. Nineteen subjects completed the study, while 1 subject withdrew due to a pretreatment event/AE."
726516|NCT02037438||
726517|NCT02037425||
726518|NCT02037347||
726519|NCT02037295||
726520|NCT02037230||
726521|NCT02037204|Patient recruitment started on February 1st 2013 and was completed in September 2014|Four patients were excluded based on MRI scans showing multiple cartilage defects and/ or osteochondral defects. Inclusion was continued until n = 35 was reached
726522|NCT02037165||
726523|NCT02037061||
726524|NCT02036840||
726525|NCT02036775||A randomised, open-label, three period, crossover study. Each subject received one treatment per treatment period. Each of the three treatment phases was 6 days long, where study drug was administered on day 1-5 during each treatment.
726635|NCT02028065||"One participant who was randomized to sugammadex 16 mg/kg instead received 3 doses of placebo and completed study. This participant appears in sugammadex 16 mg/kg column in Participant Flow period Randomization through Start Treatment and in placebo column in period Treatment through Study Completion."
726636|NCT02027883||
726526|NCT02036645|261 screening visits in 193 individuals were required to randomize 45 subjects into 6 Single Ascending Dose (SAD) cohorts and 32 subjects into 4 Multiple Ascending Dose (MAD) cohorts.|Due to population (mild to moderate Alzheimer's disease) and duration (6 or 9 months) per cohort, rescreening was permitted. SAD had 128 screeings in105 subjects (23 rescreens); MAD had 133 screenings in 88 subjects, (22 rescreens from SAD and 23 rescreens from MAD). Note: 11 of 32 randomized MAD subjects had previously completed a SAD cohort.
726527|NCT02036580|"A total of 37 patients were screened at 5 centres in Japan, and 20 patients were randomized and received at least 1 dose of tralokinumab low dose, high dose, or placebo.
~The first patient entered the study on 24 January 2014 and the last patient last visit was on 19 November 2015."|20 patients were randomized and received at least 1 dose of tralokinumab low dose, high dose, or placebo (tralokinumab low dose group: n=8, tralokinumab high dose group: n=8, placebo group: n=4).
726528|NCT02036541||
726529|NCT02036515||Two participants were randomized to Ertugliflozin 15 mg, but did not receive any treatment.
726530|NCT02036424|Subjects were recruited from the PI's clinical practice from January 2014 through October 2014.|This trial had 50 study eyes from a total of 45 participants. 5 participants had both eyes in the study.
726531|NCT02036320||206 subjects were enrolled in this study. 16 subjects did not meet the eligibility criteria. 190 subjects were dispensed lenses and, 177 subjects completed all study visits without a major protocol deviation. 13 subjects were recorded as having protocol violations. No subjects were discontinued during this study.
726532|NCT02036294||
726533|NCT02035748|Subjects were recruited from 87 study centers located in Europe and Canada (10 Italy, 5 Netherlands, 4 Poland, 4 Portugal, 12 Spain, 15 United Kingdom, 3 Belgium, 12 France, 9 Germany, 5 Hungary, and 8 Canada).|Of the 628 enrolled, 160 subjects were exited prior to initiation of treatment. This reporting group includes all treated subjects (468).
726534|NCT02035696|6 centers in the United States, 1 center in Finland, 2 centers in Thailand, 2 centers in Philippines|All enrolled Subjects were included in the trial
726535|NCT02035553||
726536|NCT02035475|Prostatectomy patients were recruited from a single robotic urologists office, between 1/15/13 and 5/12/14. The final followup visit was completed on 12/18/14.|Participants must be eligible for robotic procedures.
726537|NCT02035345||
726538|NCT02035332|Subjects were enrolled in the clinical trial at 3 investigational sites in Hungary from May 2011 until October 2011.|23 subjects enrolled: 2 subjects excluded based on pre-procedure hysteroscopy findings and did not receive treatment, in 1 subject treatment was attempted but procedure was aborted due to the width of the uterus, the remaining 20 subjects completed study treatment. The protocol ITT population included all subjects in whom treatment was attempted.
726539|NCT02035267|There were 61 subjects in the ATX-101 group and 32 subjects in the placebo group, who were further stratified by baseline Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (grade 1 included 31 ATX-101 and 16 placebo subjects; grade 4 included 30 ATX-101 and 16 placebo subjects).|
726540|NCT02035202||
726541|NCT02034916||In this study, enrollment of participants was to be done in 2 stages for each of the 2 cohorts. Sufficient responses in each cohort were observed such that enrollment could proceed to Stage 2 for both cohorts. However, due to Sponsor decision, enrollment in the overall trial was terminated early.
726542|NCT02034877||A total of 1200 (200 pediatric and 1000 adult) participants were randomized in the study. Out of the 1000 adult participants, 999 participants and all 200 pediatric participants received vaccination.
726543|NCT02034799||
726544|NCT02034708|Adult patients with known or highly suspected primary intracranial tumors and scheduled for a Dotarem®-enhanced MRI were recruited in 27 active centers in 4 countries (Colombia, South Korea, Mexico and United States) from June 2014 to September 2015.|279 patients signed an informed consent for the study and therefore were considered as included. From these 279 patients, 11 did not receive any injection : 4 for consent withdrawn, 3 for deviation from plan specified in the protocol, 2 for adverse events, 1 at the investigator's discretion and 1 for other reason.
726545|NCT02034591||37 participants were enrolled; 21 were randomized and treated. Reasons for non-randomization include 11 no longer met study criteria, 1 withdrew consent and 4 for other, not specified reasons. 20 participants completed the study; 1 withdrew consent on day 4 of treatment.
726546|NCT02034578|Participants were admitted to the clinical facility on the evening prior to dosing (Day -1) and remained confined to the clinic for the duration of study.|75 enrolled; 21 randomized; 21 treated. Of the 54 not treated: 47 no longer met study criteria, 1 not needed due to adequate number of participants, 3 withdrew consent, 1 died due to substance abuse, 1 no show, 1 discharged as alternate. Study was 3-treatment crossover administered over 3 periods. ≥4 days washout after doses in Periods 1 and 2.
726547|NCT02034565||48 participants were enrolled; 14 were randomized and treated. Reasons for non-randomization include 23 no longer met study criteria, 4 withdrew consent, 6 due to study being full, and 1 completed an alternate treatment. 13 participants completed the study.
726548|NCT02034552|Study was conducted at 19 study centers in USA from 7-Mar-2014 (first subject's first visit) to 26-Jun-2018 (last subject's last visit).|Overall, 103 subjects were screened. Of them, 68 subjects were randomized, and 63 subjects were received study treatment.
726549|NCT02034513|The trial was conducted at 90 sites in 2 countries, as follows: US: 84 sites, Poland: 6 sites.|
726550|NCT02034474||Of the 59 subjects who signed consent, 22 did not receive study drug. In addition, one of the 37 subjects who received study drug did not participate in any follow up assessments so was not included in the ITT analysis
726551|NCT02034435||
726552|NCT02034175|This is a multi-site study conducted in the United States. Study enrollment began February 2016 and concluded November 2016.|
726553|NCT02034162|The study was conducted from 8-Dec-2014 to 3-Sep-2015. A total of 295 participants were enrolled and randomly assigned to study treatment; 278 participants completed the study. Of the 295 participants, 167 participants were reported with Ascaris lumbricoides infestation and 243 participants were reported with Trichuris trichiura infestation.|Of the 792 participants screened, a total of 295 were randomly assigned to study treatments, of which 278 completed the study. 17 participants were withdrawn from study with following reasons: Withdrawal by participant (12), Lost to follow-up (3), Physician decision (1) and Protocol violation (1).
737261|NCT01328496|Fourteen patients were enrolled at St. Jude Children's Research Hospital between September 2011 and April 2014.|
726554|NCT02034123|This was planned as a 2-part, first time in human study in participants with relapsed/refractory small cell lung carcinoma. Part 1 was a dose escalation cohort and Part 2 was an expansion cohort. Participants were planned to receive GSK2879552 at a starting dose of 0.25 milligrams (mg) once daily for 28 days.|This study was terminated early during Part 1 as the risk benefit in relapsed refractory SCLC did not favor continuation of the study. Data was collected only in Part 1 and no participants were enrolled in Part 2. A total of 29 participants enrolled and received treatment in Part 1. Of which 7 prematurely withdrawn and 22 completed study.
726555|NCT02034058||
726556|NCT02034019||One subject inadvertently received PVPP instead of OTX-DP, as they had been randomized. This subject was followed safety but not included in the PP analysis.
726557|NCT02034006||Two hundred fifteen (215) subjects were screened in this study (i.e. provided written informed consent). Two hundred (200) subjects underwent baseline visit and received at least one injection of ranibizumab.
726558|NCT02033993||
726559|NCT02033889||
726560|NCT02033876||
726561|NCT02033850||
726562|NCT02033759||
726563|NCT02033694|Enrolled patients with a large LRP (Maximum Lipid Core Burden Index>250 in 4 mm or maxLCBI4mm>=250) were assigned to 2 year follow up to determine if a new coronary event had occurred. A randomly selected half of the patients with a small or no LRP (MaxLCBI4mm<250) had 2 year follow up.|A randomly selected half of the patients with a small or no LRP (MaxLCBI4mm<250) did not have 2 year follow up and were not included in the primary analyses. This reduced the total number of patients followed for two years to 1271 patients.
726564|NCT02033499|Potential participants were identified via the electronic health record (EHR) and were called to determine if they met inclusion criteria that not available from the EHR: did not plan to move or get pregnant in the next year, did not see an endocrinologist for their diabetes care, and was a patient of record in one of the 15 participating clinics.|
726565|NCT02033369||
726566|NCT02033317||The study population consisted of participants on hemodialysis between the ages of 18 and 70 years, with pre-dialysis serum potassium levels of at least 5.5 mmol/L prior to the study.
726567|NCT02033213||
726568|NCT02033200||
726569|NCT02033174||
726570|NCT02033083||
726571|NCT02033005|Participants consisted of healthy, full term, appropriate weight-for-gestational age infants from 2 cohorts: recruited between November 1999 and October 2001 at the Hammersmith Hospital, and between March 2010 and May 2012 from the postnatal ward at Chelsea and Westminster Hospital.|
726572|NCT02032901|The study was conducted at 31 sites in 2 countries.|A total of 173 participants were enrolled in the study. 152 were treated. 21 participants were not treated as they no longer met the study criteria.
726573|NCT02032888|The study was conducted at 37 sites in the United States.|A total of 238 participants were enrolled, and 203 received treatment. Of the 35 participants who were enrolled but did not receive treatment, 2 withdrew consent, 31 no longer met study criteria, 1 was lost to follow-up, and 1 was eliminated for other reasons.
726574|NCT02032875|The study was conducted at 5 centers in the United States.|A total of 116 participants were enrolled, of which 113 received study treatment (60 cirrhotic cohort, 53: post-liver transplant cohort). Remaining 3 participants no longer met study criteria. Of the 60 participants in the cirrhotic cohort, 57 did not receive a treatment extension and 3 received a treatment extension after liver transplant.
726575|NCT02032810|Participants were enrolled at Moffitt Cancer Center, November 2014 through November 2016.|
726576|NCT02032758|Subjects were recruited from Mayo Clinic in Arizona.|
726577|NCT02032706||
726578|NCT02032680|Of 96 veterans screened, 78 met eligibility criteria.|Of the 78 who were screened and met eligibility criteria, 40 consented to participate in the study. 10 of the 40 dropped out before being assigned to an intervention arm. 30 were assigned to an intervention arm.
726579|NCT02032641|All patients who had undergone direct brow lift within the last three years were contacted by telephone, and an approved script was used for recruitment.|Exclusion criteria included unilateral procedures, age less than 18 years, pregnancy, history of photodermatoses or adverse outcomes associated with laser, history of isotretinoin use within the prior six months, and active use of other scar treatment in the brow area.
726580|NCT02032550||
726581|NCT02032433||
726582|NCT02032420||
726583|NCT02032407||
726584|NCT02032238||
726585|NCT02032212||
726586|NCT02032173|Participants were recruited from 10 centers across France.|
726587|NCT02031770||
726588|NCT02031679||This study involved a 1-week screening period and a 2-week single-blind placebo run-in before randomization to active or placebo treatment. 10/38 enrolled subjects were excluded based on low disease activity (n=5), inability to remain solely on daily H1 antihistamine (n=4), and noncompliance (n=1).
726589|NCT02031640|For this study, 125 sites were activated, 115 sites screened at least 1 patient (91 centers in the United States, 10 centers in Germany, 10 centers in Hungary, and 4 centers in Poland), and 97 sites randomized at least 1 patient.|There were two periods prior to treatment assignment: a screening period and a run-in period.
726590|NCT02031536|This study was activated on January 17, 2014 and closed to accrual on March 30, 2015. Two patients, both from Stanford University, were randomized to the trial.|
726591|NCT02031471||A total of 62 participants were screened, 57 participants were enrolled. Participants who completed the 24 Week Treatment Period achieving at least a moderate European League Against Rheumatism (EULAR) response at Week 24 were allowed to enter the Long Term Extension (LTE) Period.
726592|NCT02031458|Since the primary cut-off date May 8, 2015 one participant in Cohort 1 has moved to Cohort 2 and one participant in Cohort 3 was moved to Cohort 2.|Screening was performed from Day -28 to Day -1.
726593|NCT02031432|The first participant was enrolled on the 18 Dec 2013 (first dose taken on the 19 Dec 2013 received) and the last participant completed the trial on the 03 May 2016 (last dose taken on the 12 Apr 2016). All participants in this trial completed the maintenance period in the KF6005/07 (NCT01964378) trial.|Participants who completed treatment in KF6005/07 and who were still in need of around-the-clock pain analgesia with strong opioids directly entered the KF6005/09 trial from the KF6005/07 trial. Seventy-six participants (37 previously on cebranopadol and 39 subjects previously on morphine treatment) were enrolled in this trial.
726594|NCT02031302|"There were 1014 subjects enrolled at 41 centers in Germany, UK, Italy, Colombia, Finland, The Netherlands, Poland, Spain, Israel, New Zealand, Norway, Sweden and Switzerland between 27 May 2014 and 01 Feb 2016.
~50 subjects were enrolled in the cohort with the Lotus Depth Guard valve between 13 Jun 2016 and 31 Oct 2016."|Lotus Valve cohort: 1 subject had the 1 year visit on 25SEP2015, but died on 02OCT2015, that's why the disposition table only shows 115 subjects died prior to 1 year Follow-up performed . A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 120 of 1002 patients died according to the ITT population.
726595|NCT02031276||Participants were randomized to 1 of 3 double-blind treatment arms in Period 1; those who achieved deep remission in Period 1 entered Period 2 washout; those who did not achieve deep remission in Period 1 entered Period 2 open-label (OL) treatment. Participants who were in clinical remission at the end of Period 2 continued to Period 3 OL treatment
726596|NCT02031237|Only participants enrolled onto SRS and Whole Brain Radiation Therapy arms were evaluated for the study outcomes.|
726597|NCT02030886||
726598|NCT02030847|Patients were identified through the clinical practices of the investigator or sub-investigators and through referrals from outside hospitals and physicians. No direct-to-patient advertising was performed.|
726599|NCT02030834||
726600|NCT02030821|Consenting completed at PI and co-investigators' private offices, clinic and in preoperative center. Study staff approved by the IRB consent the patients. First patient enrolled in January 2015. Last patient enrolled on 11/12/17.|Patients were excluded from the trial after enrollment if their surgery was cancelled.
726601|NCT02030600|The trial was conducted at 152 sites in the United States.|
726602|NCT02030574||
726603|NCT02030535||
726604|NCT02030405||
726605|NCT02030288||
726606|NCT02030119||One participant randomly assigned to the gain-incentive group was later found to be ineligible due to previous enrollment in another physical activity study. One participant randomly assigned to the lottery-incentive group switched to a phone that was not eligible for use before the study began and therefore did not receive the intervention.
726607|NCT02030080||
726608|NCT02030041||
726609|NCT02029989|Subjects were recruited at three community mental health sites in Minnesota site (Human Development Center - Duluth, MN; Range Mental Health Center - Hibbing, MN; Family Life Mental Health Center - Coon Rapids, MN; with subjects assigned to receive either pharmacist CMM services (PCS) or no pharmacist CMM services (NCS)/Control Group.|
726610|NCT02029976|Cohorts of children along with a parent were recruited annually from 2014 to 2017 and January through May, for a total of 4 cohorts. Data analyses of primary and secondary outcomes did not occur until cohort 4 completed the year 2: follow up measurement in August 2019.|
726611|NCT02029911|Subjects were enrolled in the clinical trial at 3 investigational sites in Canada from June 2011 until October 2011.|63 subjects enrolled: 3 subjects excluded based on pre-procedure hysteroscopy screening and did not receive treatment. The remaining 60 subjects completed the study treatment. The protocol ITT population included all subjects in whom treatment was attempted (the experimental device was attempted to be placed).
726612|NCT02029872|Recruitment took place from January 2014-March 2015 in an outpatient HIV clinic in Baltimore, Maryland|Enrolled participants were screened for Methicillin-resistant Staphylococcus aureus (MRSA). Only those with a positive MRSA swab in any body site (nares, throat, perineum, rectum, vagina) were randomized to an arm of the study to receive the decolonization protocol.
726613|NCT02029846||
726614|NCT02029755||
726615|NCT02029703||
726616|NCT02029638||
726617|NCT02029521||
726618|NCT02029495||
726619|NCT02029417||
726620|NCT02029274|The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered to all randomized at the dose of 2 mg daily .|Participants were randomized to each treatment group in a1:1:1:1 ratio.
726621|NCT02029235|Participants were recruited during clinic visits to discuss elective, soft tissue hand surgery at a single academic medical center between February 2015 and October 2017. The first participant was enrolled in February 2015, and the last participant was enrolled in October 2017.|Seven patients withdrew or were excluded prior to randomization due to cancellation of surgery (3), refusal to participate (3), and a newly diagnosed gastrointestinal ulcer (exclusion criterion) prior to surgery (1).
726622|NCT02029196||
726623|NCT02029040||
726624|NCT02028884|Participants took part in the double-blind (DB) period up to the clinical cut-off date (CCOD: 06 June 2018). The CCOD was defined by the onset date of the 26th clinical endpoint committee-confirmed protocol-defined relapse (PDR). The study is ongoing in the open-label extension (OLE) period.|
726625|NCT02028871||
726626|NCT02028780||Randomised, double-blind within dose groups, placebo controlled, sequential rising order, single centre trial. This study has two phases ie., Observation phase (Single administration of placebo or BI study drug and 6-14 days follow up) and Follow up phase (End of observation phase to 92-98 days after administration of Placebo or BI study drug).
726627|NCT02028767||
726628|NCT02028754||
726629|NCT02028715|68 participants were enrolled between December 2013 and May 2014 at local institution|
726630|NCT02028676|All recruited children (n=1206) were randomly assigned to CDM vs LCM and the three different induction ART strategies at enrolment (3/2007-11/2008). This was a factorial randomisation meaning that the children were effectively randomized into 6 parallel groups. Baseline characteristics are presented below separately for each initial randomization.|There were two additional nested substudy randomizations after initial trial enrolment (see inclusion/exclusion criteria for eligibility). From 8/2009 to 6/2010, eligible children were randomized to once vs twice daily abacavir+lamivudine. From 9/2009 to 2/2011, eligible children were randomized to stop vs continue cotrimoxazole prophylaxis.
726631|NCT02028325||10 participants failed screening
726632|NCT02028208||
726633|NCT02028182||
726634|NCT02028169||
726750|NCT02018653|Recruitment Period: December 16, 2013 to August 1, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Clinical trial closed due to slow accrual.
744976|NCT00908076||
726637|NCT02027844|This study was conducted Yeungnam University Hospital in South korea from Dec. 30. 2013 to October. 31. 2014. One hundred and seventeen children aged between 2 and 7 years, ASA physical status I or II scheduled for elective minor surgery under general anesthesia were enrolled. .|Children with a chronic illness, developmental delay, a neuropsychiatric disease, cancer, experience of a recent stressful life event, previous anesthetic experience, sedative medication, or emergency surgery were excluded.
726638|NCT02027701||
726639|NCT02027623|Recruitment was by way of flyers placed in the community and physician offices, ads and interviews through local media and clinics in the region. Recruitment spanned December 2013 to August 2016.|
726640|NCT02027558||
726641|NCT02027545||
726642|NCT02027428|The study was conducted at 87 sites in Germany, Italy, Spain, the United Kingdom and the United States.|Participants with a response or stable disease during Induction were randomised 2:1 into investigative treatment (nab-paclitaxel plus best supportive care [BSC] or BSC only) stratified by disease stage, response during induction and Eastern Cooperative Oncology Group (ECOG) performance status.
726643|NCT02027402||
726644|NCT02027376|12 patients were enrolled in this trial in the 5 Spanish centers receiving at least one cycle of the combination of oral LDE225 (sonidegib) with intravenous docetaxel. 5 patients were included at Dose Level (DL) 1, 4 patients at DL 2 and 3 patients at DL 3. Two patients at DL 1 and 1 patient at DL 2 were replaced due to early progressive disease.|Two patients at DL 1 and one patient at DL 2 were replaced due to early progressive disease before completing the first 2 cycles.
726645|NCT02027311|Eligibility was evaluated for all patients with a scheduled ERCP procedure in the Cheju Halla General Hospital during the study period from May 15 2013 to Aug 19 2013. Sample size estimated 26 of each groups for reject null hypothesis with probability (power) 0.8 and Type I error is 0.05.|68 patients were enrolled and 35 were assigned in the MDZ group and 33 were in the ETM group. In ETM group, 1 case was dropped due to hypotension and 2 were desaturation. And 1 cases was dropped due to tachycardia and 1 were desaturation in MDZ group.
726646|NCT02027272||
726647|NCT02027025||
726648|NCT02026687||
726649|NCT02026453|Eligible participants were medically complex patients admitted to Cedars-Sinai Medical Center, a large university-affiliated hospital, through the emergency department. Enrollment screening occurred Mondays through Thursdays from approximately 11 AM to 8 PM beginning 1/7/2014 through 2/14/2014.|
726650|NCT02026297||
726651|NCT02026258||
726652|NCT02026206||
726653|NCT02026193||
726654|NCT02026141||
726655|NCT02026063||Participants whose participation was ongoing in 1 of the following studies [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415), LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)] were eligible to enroll in this long-term safety study at the same dose received in the previous (parent) study.
726656|NCT02026011||A total of 199 individuals were screened in the laboratory, of those 106 completed the physical exam, and of those 87 were eligible and agreed to be randomized. Participants received in random order either Naltrexone (titrated up to 50 mg/day) or Placebo at each Allocation.
726657|NCT02025907||One participant was randomized at 2 different sites (once to placebo and once to canagliflozin) and was therefore counted twice in the total number of randomized participants. The participant was withdrawn from the study and not included in any efficacy or safety analyses.
726658|NCT02025829||
726659|NCT02025751||
726660|NCT02025725|"Recruitment Period: 27 March 2014 to 27 May 2016
~Types of Location: Medical Clinics, University-Based Practices
~Screening Period consisted of Washout Period, Qualification Period and Baseline Period. Mean daily Gastroparesis Symptom Assessment (GSA) total score ≥ 1.4 and ≤ 3.5 was required during Qualification and Baseline periods"|"613 participants Screened, 205 participants completed and randomized to treatment.
~Negative Gastric Emptying Scintigraphy 129 Inclusion/Exclusion Failed 213 Withdrawal by participant 25 Other Reasons 41"
726661|NCT02025647|This study is comprised of a series of 3 study sessions spanning a maximum participation period of 30-45 days. All subjects are intended to complete Study Session 1 and 2, spanning a duration of 24-48 hours. Those subjects who endorsed enough diagnostic symptoms to generate an Individualized Rating Scale will participate through Study Session 3.|
726662|NCT02025634||
726663|NCT02025621||
726664|NCT02025530|Participants were recruited between April 2014 and March 2016 from 41 maternity units around the United Kingdom.|This was a case-control study, so participants were not assigned to a specific arm/group. 5 cases (women who had a stillbirth) were excluded prior to analysis because the baby was found to have a congenital anomaly at post-mortem examination. One control (women with a live baby at interview) was excluded because she had a stillborn baby.
726665|NCT02025439||nothing to report
726666|NCT02025426||
726667|NCT02025205||
726668|NCT02025179||
726669|NCT02025075||
726670|NCT02024971|Participants took part in the study at 196 investigative sites in Japan from July 2010 to November 2013 (N=1103).|Patients with type 2 diabetes mellitus for whom a physician has concluded that therapy with pioglitazone hydrochloride combined with metformin hydrochloride is suitable and for whom long-term treatment with Metact Combination Tablets is considered necessary.
726671|NCT02024932|This study was conducted in 2 parts, Part A and Part B. In Part A, Cohort 1 participants received open-label BVS857. Cohort 2 participants were randomized to double-blind BVS857 or double-blind placebo in a 2:1 ratio.|In Part B, Cohort 3 was not enrolled. Cohort 4 participants received open-label BVS857. Cohort 5 participants were randomized to double-blind BVS857 or double-blind placebo in a ratio of 18:10.
726672|NCT02024867||
726673|NCT02024750||
726674|NCT02024724||
726675|NCT02024711||
726676|NCT02024698||
726677|NCT02024646||
726678|NCT02024555||446 participants were screened but only 97 participants met inclusion/exclusion and were randomized.
726679|NCT02024477|Subjects were recruited from clinic of the Principle Investigator and Sub-Investigators involved in the trial. First patient was recruited on 26 Nov 2013, last patient was recruited on 24 May 2016.|Screening period lasted 2 weeks. No wash-out or run-in periods were necessary.
746413|NCT00833755||
749640|NCT00676676||
726680|NCT02024386||Six additional subjects were consented but not enrolled. Two subjects failed the screen due to a VO2 max less than the inclusion criteria. Two subjects were withdrawn when the Swan-Ganz catheter could not be placed. One subject was unable to schedule an experimental date and one subject did not return for screening.
726681|NCT02024165||
726682|NCT02024087|First subject enrolled 04-AUG-2014 Last subject completed 05-JUL-2017 Study conducted at academic oncology centers in the US|
726683|NCT02023983||
726684|NCT02023944||One participant was recruited, assigned to the control group, and then dropped out before the baseline due to dissatisfaction with group assignment.
726685|NCT02023918||
726686|NCT02023879|The study was conducted at 43 centers in 8 countries. A total of 402 participants were screened between December-2013 and May-2014, of whom 233 were randomized for double-blind (DB) treatment period and 169 were screen failures. Out of 233 randomized for DB period, 205 participants entered the optional open-label (OL) extension period.|Randomization was stratified by statin intolerant status & background therapy (non-statin lipid therapy vs diet). Randomization followed a 1:2:1 ratio for placebo, Alirocumab 75 mg and Alirocumab 150 mg instead of 1:1:2 as initially planned due to systematic error in treatment allocation algorithm discovered after all participants were randomized.
726687|NCT02023866||
726688|NCT02023801|Subjects were enrolled in the clinical trial at 1 Investigational Site in Mexico. All subjects were enrolled during September 2011.|24 subjects enrolled: all subjects met the study criteria including hysteroscopic screening prior to the procedure. All 24 subjects completed the treatment. The protocol ITT (Intent-To-Treat) population included all subjects in whom treatment was attempted (i.e., all subjects in whom the experimental device was attempted to be placed).
726689|NCT02023697||Of the 391 participants assigned to treatment in the intention to treatment (ITT) analysis set, 370 participants (94.6%) received at least one dose of radium-223 dichloride, and a total of 21 participants (5.4%) never received treatment
726690|NCT02023515||
726691|NCT02023411|Recruitment will be performed from Diabetic Foot clinic of Tertiary care hospital from March 2016 to December 2017|
726692|NCT02023268||
726693|NCT02023242|Patients were screened and enrolled at 12 investigational sites located outside of the United States|152 patients were randomized
726694|NCT02023151||
726695|NCT02023125||
726696|NCT02023112||
726697|NCT02023099||
726698|NCT02022826|Recruitment period- January 2014 March 2017; 11 academic and community centers within the US|medication wash out period: Subjects instructed to discontinue agents that affect intragastric acidity including proton pump inhibitors for 7 days, histamine2 receptor antagonists for 3 days and antacids for 1 day prior to study including the day of SPM ingestion.
726699|NCT02022748|56 subjects signed ICF, 34 Hemodialysis (HD) subjects and 22 Healthy subjects (HS) at 2 study centers in the US. 27 subjects received treatment (14 HD and 13 HS). First patient signed ICF on 29 December 2013. Due to protocol amendment, the first patient was randomized 22 months later on 20 October 2015, last patient last visit was 09 May 2016.|21 out of 34 HD subjects were randomized (13 failed to fulfill eligibility criteria) and 14 were eligible after eligibility re-assessment (5 no longer met the eligibility criteria and 2 experienced Adverse Events (AE) prior to treatment). 13 out of 22 HS were eligible to be treated (9 failed to meet the eligibility criteria).
726700|NCT02022670|Healthy men and women ages 50-79 years free of overt cardiovascular or chronic diseases.|
726701|NCT02022657||52 subjects from 2 sites were analyzed-- CU enrolled only 34.
726702|NCT02022111|Once informed consent was obtained, a blinded outcomes assessor conducted a detailed baseline assessment. Following this, blinded study staff assigned participants to receive intervention or usual care using a password-protected web-based data management system (Interactive Web Response System [IWRS]).|
726703|NCT02022085||
726704|NCT02022020|This was an observational chart abstraction study.|297 subjects were captured in the initial screening. 74 patients were deemed ineligible. A total of 3 patients were withdrawn after being included in the final study cohort following verification of ineligibility leaving 220 subjects eligible for study entry who were enrolled and included in the final study.
726705|NCT02022007|PCOS women age 18 and 42 years and impaired glucose regulation were enrolled in the study from March 2014 to January 2016. PCOS was defined according to modified National Institutes of Health [NIH] 1990 criteria. ). Prediabetic hyperglycemia was determined by a 75-gram OGTT and included impaired fasting glucose (IFG), IGT, or both (IFG/IGT).|Exclusion criteria included diabetic subjects, smokers, suspected pregnancy, desiring pregnancy or injectable hormonal contraceptive use within 6 months; and use of oral contraceptives, other steroid hormones, drugs that affect gastrointestinal motility or carbohydrate metabolism and/or anti-obesity drugs within 3 months prior to study entry.
726706|NCT02021942|This monocentric trial was conducted in Regensburg, Germany. The patients were asked for study participation by the investigator.|
726707|NCT02021929||
726708|NCT02021812||
726709|NCT02021669||
726710|NCT02021656|Participants were enrolled at study sites in Mainland China (referred to as China throughout this results record), Korea, and Taiwan. The first participant was screened on 10 December 2013. The last study visit occurred on 29 September 2017.|416 participants were screened.
726711|NCT02021643|Participants were enrolled at 61 study sites in Asia. The first participant was screened on 10 December 2013. The last study visit occurred on 03 November 2016.|815 participants were screened.
726712|NCT02021565|Recruitment began in December 2013 and ended June 2016. Potential Veterans and informal/family caregivers were identified through the Department of Veterans Affairs Corporate Data Warehouse. The study was also advertised at community events and in local newspapers.|
726713|NCT02021461||
726714|NCT02021331||
726751|NCT02018627||"20 subjects were enrolled in this study. One was ineligible after enrollment. 4 were enrolled and eligible, but were not able to schedule their study visit. 2 participated in test run experiments as we adjusted glucagon doses to account for concentration differences. 13 subjects completed experiments using the same protocol."
726752|NCT02018562||
726753|NCT02018458||
727230|NCT01985581|Subjects were recruited from principal investigators clinical practice as well as through advertisement in local medical offices and through print and radio advertisements|
726715|NCT02021292|A total of 48 sites in 20 countries screened subjects for recruitment. The study was conducted (i.e., randomized subjects) in a total of 36 sites across 16 countries: Belgium, China, Czech Republic, France, Germany, Hungary, Lithuania, Mexico, Poland, Russia, Thailand, Turkey, South Korea, Switzerland, Ukraine, and the United Kingdom).|Target screening period from Visit 1 up to Randomization was maximum of 30 days, but longer period (up to 60 days) was permitted with pre-approval from Actelion. Total of 186 subjects were screened. Of these, 80 subjects were randomized in 1:1 ratio to macitentan 10 milligram (mg) (n = 40) and placebo (n = 40). All randomized subjects were treated.
726716|NCT02021071|The enrollment of patients occurred between December 3rd 2013 and June 9th 2014.|
726717|NCT02020941|This protocol was based on enrolling 23 patients. Due to slow accrual, the study was closed with 10 patients enrolled.|
726718|NCT02020889|Eligible participants at screening and run-in visit, entered a 52 week study treatment phase followed by 8-week follow-up phase. The total duration for the study participation was approximately 64 weeks.|A total of 151 participants with a history of relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) were screened, out of which 4 were screen failures and 11 were run-in failures. 136 participants completed run-in period and received Mepolizumab 300 milligram (mg) or placebo in a randomized manner in the treatment phase.
726719|NCT02020863||
726720|NCT02020837||
726721|NCT02020785|Primary recruitment strategies included mass mailing of study brochures to individuals with self-reported type 2 diabetes in neighboring zip codes and to past and current participants of other research studies.|
726722|NCT02020616||The study was planned in 2 stages; Stage 1 evaluated up to 5 escalating parallel-dose groups. Stage 2, which was to evaluate participants stratified by Hemoglobin A1c (HbA1c), metformin therapy, and washout of a second oral anti-hyperglycemic medication (OAM) was not conducted because of inadequate efficacy at well-tolerated doses in Stage 1.
726723|NCT02020577||"Uncontrolled, open label, 3+3 dose escalation (Part A) study of afatinib in combination with cetuximab, followed by an expansion phase in 3 cohorts of patients (Part B). Adverse Event (AE).
~CTCAE: Common Terminology Criteria for Adverse Events"
726724|NCT02020512||
726725|NCT02020408||
726726|NCT02020369||
726727|NCT02020304||
726728|NCT02020278|Eligible participants included those enrolled in a previous tolvaptan pediatric trial for hyponatremia (NCT02012959); who provided written informed consent at baseline and were able to understand that he/she could withdraw at any time; with the ability to comply with all requirements of the trial; ready to be followed up for 6 months.|There was no screening phase. Approximately 100 male or female participants were planned to be enrolled in this trial. A total of 3 participants were enrolled in this trial, but no participant received optional investigational medicinal product during this trial.
726729|NCT02020135||
726730|NCT02020031|Subjects were enrolled between January 2014 and April 2015 at Mayo Clinic in Arizona.|
726731|NCT02020018||
726732|NCT02019979|Recruitment began in December 2013 with enrollment from Jan 2014 to April 2016 at 3 sites. 17 initially enrolled, but 3 came off study prior to beginning therapy and not included in analysis.|
726733|NCT02019940||
726734|NCT02019927||
726735|NCT02019758||
726736|NCT02019719|This was a study to evaluate dose-response of GSK1278863 in approximately 95 Japanese Hemodialysis-dependent (HDD) participants with anemia associated with Chronic Kidney Disease (CKD) conducted across 21 centers in Japan from 05 November 2013 to 06 August 2014.|This study consisted of a screening phase of 3-9 Week , a 4 Week treatment phase and a follow-up visit that occurred approximately 4 Week after completing treatment. Study completion was defined as completing the final visit including those in the follow-up period.
726737|NCT02019667|Participants were recruited and enrolled in the protocol between March 2014 and October 2017, with assistance from referring physicians in the community and the SSADH foundation. A total of 19 participants were enrolled; 16 completed dosing in both placebo and active drug arms.|Following a baseline visit, participants were randomized to receive either placebo or study drug for 6 months (Phase 1) followed by 6 months of the alternate treatment (Phase 2). Participants completed a 9-week washout period following each phase of the study.
726738|NCT02019602|The study started to enroll patients in January 2014 and concluded in November 2016.|The Participant Flow refers to the Safety Set for Mothers [SS-M] and the Safety Set for Infants [SS-I]. For mothers, Baseline is defined as their screening visit. Since babies are regarded as study participants once they are born, baseline for the infants is considered to be the day of their birth.
726739|NCT02019563|Subjects were recruited at The Hospital for Sick Children between September 2010 and September 2012.|
726740|NCT02019550|The study was conducted at 32 sites in the United States.|Overall, 103 subjects were screened, for inclusion in this trial. Of which, 97 subjects were randomized into the study.
726741|NCT02019472||A total of 559 participants were randomized and treated. All participants received at least one administration of study treatment.
726742|NCT02019420|Ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) were enrolled at study sites located in 34 countries.|
726743|NCT02019277||
726744|NCT02019264|Participants took part in the study at investigative sites in the United States, Bahamas, Canada, Mexico, Chile, New Zealand, Poland, and Australia from 24 Jan 2014 to 14 May 2018.|A total of 14,673 participants were screened and enrolled, of which 2673 participants were screen failures and 12,000 were randomized to receive lorcaserin hydrochloride (HCl) or placebo.
726745|NCT02019108||
726746|NCT02019069||
726747|NCT02018887||This study had 3 parts. Part A-Single ascending dose, 3-period, crossover study (Cohorts 1-2). Part B-Multiple ascending dose, parallel study (Cohorts 3-7). Part C-Multiple dose, single dose level study (Cohort 8). Each participant enrolled in 1 cohort. Replacement participants received interventions intended for those that discontinued early.
726748|NCT02018822||50 participants received both TPH3 and UDMA in a split-face design, with the most anterior or right tooth randomized to one intervention and the most posterior or left tooth randomized to the second intervention. An additional 35 participants were included for treatment with Esthet-X and could receive the intervention on more than one tooth.
726749|NCT02018809||
726935|NCT02005445||
726754|NCT02018445|During the study in which each patient undergoes posterolateral fusion (PLF). During PLF, each spinal level is treated with two graft materials, the symptomatic posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral non-symptomtic posterolateral gutter is treated with the control arm (local autograft).|
726755|NCT02018315||
726756|NCT02018107|"33 unique participants were enrolled and consented for this study, 6 participants were then excluded from the study.
~Thus, the count of subjects is 27 who were assigned to intervention. Out of 27 participants, 1 subject participated in both interventions."|"33 unique participants were enrolled and consented for this study, 6 participants were then excluded from the study.
~Thus, the count of subjects is 27. Out of 27 participants, 1 subject participated in both interventions."
726757|NCT02018042||
726758|NCT02017964|This study opened for entry on December 24, 2013, and the first patient was enrolled on April 22, 2014. The study enrolled 26 patients before being closed early due to inferior efficacy as of July 27, 2016. 25 of the 26 patients enrolled were deemed to be eligible|
726759|NCT02017899||
726760|NCT02017860|A total of 4 subjects were enrolled in the study and received at least one dose of everolimus. Of the 4 subjects, 2 subjects terminated treatment due to study closure by sponsor as approximately 5 years had elapsed since first patient first visit (FPFV). One subject terminated treatment due to an Adverse Event (AE) and one subject withdrew consent.|
726761|NCT02017574||
726762|NCT02017535||
726763|NCT02017522||Five potential participants signed consents, but only three passed screening.
726764|NCT02017327|patients were enrolled at medical clinics from Dec 2013 to July 2016|the number of patients enrolled in 379 but as the primary Endpoint is Safety, the Baseline population is based on the safety Set and it corresponds to 373 patients
726765|NCT02017223||
726766|NCT02017210||
726767|NCT02017171||
726768|NCT02017093||
726769|NCT02017015|This multi-center study was conducted by investigators in China and enrolled patients at a total of 13 sites. This study was designed to be a Chinese bridging study to complement the global pivotal study (CA046).|
726770|NCT02016963|Participants who had received raxibacumab >= 4 months in another HGS study (study # HGS1021-C1064) prior to this study were eligible for enrollment in this study.|
726771|NCT02016898||Two subjects were retroactively removed due to not satisfying the inclusion/exclusion criteria. An additional three subjects had uncertain group allocation due to clerical errors.
726772|NCT02016885||
726773|NCT02016716|This study was conducted at 11 centers: 7 in Poland, 2 in the Czech Republic, and 2 in the United States. The first participant enrolled on 03 December 2013 and the last participant enrolled on 07 March 2014.|"Eligible participants were randomized in a 22:5:22:5 ratio to receive
~romosozumab 90 mg/mL
~placebo 90 mg/mL
~romosozumab 70 mg/mL
~placebo 70 mg/mL
~For efficacy analyses the 2 placebo groups were combined, for safety analyses the data were reported separately."
726774|NCT02016690||Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.
726775|NCT02016625|The trial was nonrandomised, open-label and fixed-sequence and was performed in 2 separate groups of 2 periods each in healthy male and female volunteers. Treatments for the two periods were in group 1 cyclosporine (cyclo) and cyclo and faldaprevir (FDV), and in Group 2 tacrolimus (tac) and tac and FDV.|
726776|NCT02016612||
726777|NCT02016560|Exploratory cohort subjects were enrolled starting in Dec 2013. Confirmatory cohort subjects were enrolled Dec 2014-July 2017. Exploratory cohort subjects were not eligible for the confirmatory phase.|To ensure a distribution of disease severity in the confirmatory phase, a target was set to recruit at least one-third of the enrolled subjects with dementia
726778|NCT02016482||
726779|NCT02016300||
726780|NCT02016235||
726781|NCT02016183|Participants took part in the study at 557 investigative sites in Japan, from 01-Apr-2009 to 30-Sep-2012.|Participants with a diagnosis of hypertension were enrolled to receive candesartan cilexetil/hydrochlorothiazide 4 mg/6.25 mg or 8 mg/6.25 mg combination tablets, orally, once daily for up to 12 months as per routine medical practice.
726782|NCT02016170|Between March 2014 and October 2015, a total of 150 patients on maintenance DAPT with aspirin and prasugrel were identified. Of these, 83 patients meeting study entry criteria agreed to participate and provided their written informed consent.|One patient was excluded after providing informed consent because of inadequate venous access. Thus a total of 82 patients were randomized.
726783|NCT02016105|661 patients were screened. 465 patients were randomized 1:1 into Treatment Period 1 and stratified by region (US/EU), body weight (<90/≥90 kg) and prior systemic therapy (no/any). In Treatment Period 2 patients were re-randomized 2:1 to either continue originally assigned treatment or switch treatment and were stratified by region only.|"Screening lasted for at least 2 weeks and up to 4 weeks. Main inclusion criteria:
~Men or women of at least 18 years
~Chronic plaque-type psoriasis ≥ 6 months before randomization
~Moderate to severe psoriasis :
~PASI score ≥ 12
~IGA score ≥3
~BSA affected by plaque-type psoriasis ≥ 10%
~No previous exposure to adalimumab"
726784|NCT02015910||
726785|NCT02015793||
726786|NCT02015754|This study enrolled patients diagnosed with colorectal cancer with unresectable hepatic metastases who have failed or were intolerant to at least one line of systemic chemotherapy or liver-directed therapy. Patients were enrolled at Johns Hopkins to receive transarterial chemoembolization (TACE) therapy. The last patient completed in June 2015.|
726787|NCT02015676||
726788|NCT02015663|The study intended to randomize 200 patients in 18 months; however, after 9 months, only 25 patients were randomized, with a screen fail rate of 50%. Due to premature termination, summaries and analyses planned in the protocol were eliminated in the statistical analysis plan prior to database lock. No inferential analysis will be provided.|
726789|NCT02015637||
726790|NCT02015546|All subjects who signed a consent form were randomized to a treatment group. 6 subjects were screen failures and did not begin taking the study drug.|
726791|NCT02015481||
726792|NCT02015442||
727231|NCT01985425||
727232|NCT01985360||
726793|NCT02015234|One hundred fifty-eight (158) of the 174 patients who completed 12 weeks of treatment in Study F202 were eligible and consented to participate in the 12-month safety extension study.|Restricted to patients who completed the lead-in double-blind study and continued to meet the inclusion/exclusion criteria.
726794|NCT02015221||
726795|NCT02015195|Healthy human subjects were recruited by advertisement on Stanford University campus during the months of May and June, 2013 for a study that took place within a medical ward within a hospital during July, 2013. 97 patients were enrolled.|Volunteers were excluded if they were pregnant, had a history of allergic reaction to prior jellyfish or insect sting, a family history of severe allergic reaction to jellyfish or insect sting, or a history of heart or lung disease.
726796|NCT02015104||
726797|NCT02015065||Due to lack of efficacy no participants were enrolled in Dose Level 150mg/m^2 Vandetanib Pediatric Arm/Group.
726798|NCT02015039|Subjects with Writer's Cramp were recruited from a monthly botulinum clinic at NIH.|Subjects with Writer's Cramp with varying degrees of severity were randomized to receive either botulinum toxin therapy only or botulinum toxin therapy plus occupational therapy.
726799|NCT02014740||
726800|NCT02014597|Normal subjects were recruited by word of mouth (medical clinic staff, employees, friends, relatives); Glaucoma subjects were recruited from a glaucoma specific clinic.|
726801|NCT02014584|The study consisted of a Screening Visit, a 4-week Placebo Run-in Period, a 24-week Double-Blind (DB) Treatment Period, followed by a 24-week Open-Label (OL) Active Treatment Period, and a 4-week post-treatment Follow-Up Visit.|Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
726802|NCT02014558|This dose-escalation/dose-expansion study was conducted in sites in the United States, France, Germany and Italy. The study had 7 dose-escalation cohorts with ≥3 participants enrolled at each dose level. Following escalation to the next dose cohort, additional participants were enrolled to the dose-expansion cohorts per protocol-specified criteria.|Participants with acute myeloid leukemia (AML) who relapsed after or were refractory to induction or salvage treatment were selected for this study. Five participants were re-enrolled into the dose-expansion cohorts as they discontinued treatment for reasons other than toxicity or disease progression, as long as they met the eligibility criteria.
726803|NCT02014519||
726804|NCT02014480||Participants who met the eligibility criteria at Screening (Visit 1) completed a 5- to 7-day Run-in Period prior to being randomized to 1 of 6 treatment sequences. The treatment phase was comprised of three 14-day treatment periods, each separated by a 10- to 14-day washout period.
726805|NCT02014467|The study design consists of two phases: Screening Phase and 12-month Double-blind Treatment Phase. The Screening Phase was to last up to a maximum of 2.5 months, which was followed by a 12-month Double-blind Treatment Phase. The total participation time in the study was approximately 14.5 months.|A total of 909 participants were screened, of whom 485 were randomized in a 3: 1 ratio to receive one of the two study treatments. A total of 484 participants received at least single dose of investigational product (IP).
726806|NCT02014441|This study was conducted at 11 centers in the United States and Canada. The first participant was enrolled on 07 April 2014 and the last participant was enrolled on 07 December 2015.|
726807|NCT02014402||
726808|NCT02014376||
726809|NCT02014363||
726810|NCT02014272||
726811|NCT02014129|Participants completed the trial if they received at least one dose of study drug and met discontinuation criteria.|
726812|NCT02014116||The study consisted of two parts: Part A, a dose escalation phase to determine recommend Phase 2 dose. During Part A, safety data will be assessed and used as primary criteria for dose escalation. Part B, a tumor-specific expansion of treatment groups (cohorts) for dose confirmation.
726813|NCT02014051||
726814|NCT02013830||
726815|NCT02013817||
726816|NCT02013791||This study was terminated. Stage 2 of the study was not conducted.
726817|NCT02013778||
726818|NCT02013765||
726819|NCT02013687||
726820|NCT02013674||
726821|NCT02013622|This was an exploratory phase 3b, multicenter, open-label, monotherapy, flexible-dose brexpiprazole trial designed to assess the efficacy and safety of brexpiprazole in participants with early-episode schizophrenia.|The trial consisted of a 2 to 21-day screening phase, a 16-week (112-day) treatment phase, and a 30-day (+2) follow-up phase. The treatment phase was split into a medication conversion period (2, 3, or 4 weeks) and a brexpiprazole monotherapy period (14, 13, or 12 weeks) respectively.
726822|NCT02013609|This trial was conducted in 48 participants at 24 sites in the United States; 15 of the 24 trial sites enrolled participants.|The trial consisted of a 2 to 21-day screening phase, a 12-week (84-day) treatment phase, and a 30-day (+ 2) follow-up phase.
726823|NCT02013544|A total of 1226 subjects were screened at 38 medical/research sites located in the US (24 centers) and Canada (14 centers) and 558 subjects were randomized. The first subject first visit was on 11-FEB-2014 and the last subject last visit was on 06-JAN-2015.|
726824|NCT02013531|This trial was conducted in 37 participants. 18 trial sites were initiated in the United Sates, and 12 trial sites enrolled participants.|The trial consisted of a 2- to 21-day screening phase, a 6-week (42-day) treatment phase, and a 30-day (+ 2) follow-up phase.
726825|NCT02013414||
726826|NCT02013388||
726827|NCT02013375|Subjects are referred by their primary care physicians to the UIC Sickle Cell clinic for specialty care. Subjects are evaluated to see if they are eligible for studies and if they are, the subject is presented with the option of enrolling into a research study or participating in alternative therapies that have also been presented to the subject.|
726828|NCT02013245||
726829|NCT02013206||
726830|NCT02013180||
726936|NCT02005393|Twenty subjects were recruited at Mayo Clinic, Scottsdale between 23Oct2013 and 08Nov2013 to have two endoscopies completed - one using Fujifilm's endoscope and processor equipped with FICE, and the second immediately following with Olympus' endoscope and processor equipped with NBI.|
727233|NCT01985334||
746491|NCT00830284||
746492|NCT00830258||
726831|NCT02013167|"This study was conducted at 101 centers in 21 countries in Asia, Australia, Europe, and Latin and North America.
~The first participant was enrolled on 03 January 2014 and treated on 06 January 2014. The last participant enrolled on 25 September 2015 and the data cutoff date for this report was 04 January 2016."|Participants were randomized in a 2:1 ratio to either blinatumomab or standard of care (SOC) chemotherapy regimens. Randomization was stratified by age (< 35 years vs ≥ 35 years), prior salvage therapy (yes vs no), and prior allogeneic hematopoietic stem cell transplantation (HSCT) (yes vs no) as assessed at the time of consent.
726832|NCT02013050||Two patients were randomized but never received study drug and are excluded from the analyses
726833|NCT02012959||
726834|NCT02012686||
726835|NCT02012621||
726836|NCT02012608||
726837|NCT02012582||
726838|NCT02012491|We randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed to receive pretreatment with 200 mg of mifepristone, orally, followed by 800 μg of misoprostol, administered vaginally (mifepristone-pretreatment group), or 800 μg of misoprostol alone, administered vaginally (misoprostol-alone group).|
726839|NCT02012452|19 participants came in for an in-person screening visit. Of those, 9 met inclusion criteria.|
726840|NCT02012348||
726841|NCT02012283|The enrollment period was 11/2012 - 6/2013. The enrollment took place in a private setting the clinic located at the site.|Twenty subjects completed a general recruitment questionnaire were recruited. They were categorized based on their score on the Three-Factor Eating Questionnaire with score greater than 2 defined as high restraint eaters, and 2 or less defined as low restraint eaters. First Intervention was broccoli, second was cauliflower and third was spinach.
726842|NCT02012218|This trial was conducted in 61 participants in 28 trial sites, all of which were located in the United States.|The trial consisted of a continuous 6-week open-label treatment period including an initial 2-week titration period with a 30-day (+2 days) follow-up period.
726843|NCT02012192||
726844|NCT02011945||35 Participants enrolled; 31 participants randomized. Reasons not randomized: 1 participant withdrew consent, 3 participants no longer met the study criteria.
726845|NCT02011893||
726846|NCT02011542||This study is ongoing; information on enrolled participant arm assignment is blinded, therefore these arms/groups are combined
726847|NCT02011516|"Recruitment Timeframe: 12/2013-10/2014
~Potential subjects were recruited via word of mouth, flyers, craigslist and targeted Facebook ads
~47 potential subjects were enrolled (consented), 41 were screened, 22 passed screening, 21 baseline scan, 16 randomized, 13 treatment scan, 8 post-tx scan, 10 completed."|All enrolled participants, those that consented to study procedures, participated in a screening process that consisted of a physical and psychological evaluation. Those participants that did not meet our specific inclusion criteria, and/or those that met our exclusion criteria, were not assigned to groups. These individuals were given referrals.
726848|NCT02011490||33 subjects participated in study. 9 participated in both Part 1 and Part 2; for these, separate Part 2 baseline assessments were obtained. Due to differing Part 1 and Part 2 baseline renal function result, 1 participant was in severe renal insufficiency group in Part 1 and moderate renal insufficiency group in Part 2.
726849|NCT02011464||
726850|NCT02011386||
726851|NCT02011113|All study participants who were on pomalidomide were transferred to the post-marketing study and continued the study treatment when pomalidomide became commercially available.|Treatment phase discontinuation occurred when a participant had confirmed progressive disease, development of unacceptable toxicity, voluntary withdrawal or met other criteria for treatment discontinuation.
726852|NCT02010996||
726853|NCT02010775||
726854|NCT02010697||
726855|NCT02010684||
726856|NCT02010645|Recruitment period: March 2014 to February 2015|
726857|NCT02010632||
726858|NCT02010567|Patients were recruited from 5 medical institutions between December 2013 and September 2016|A total of 39 patients were consented to this study; 4 patients were found ineligible, 3 withdrew prior to treatment, leaving 32 patients who went on study.
726859|NCT02010359||
726860|NCT02010255|Participants were enrolled at study sites in Europe, Canada, Australia, and New Zealand. The first participant was screened on 14 January 2014. The last study visit occurred on 27 August 2015.|"Cohort A: decompensated cirrhosis [advanced liver disease], no prior liver transplant;
~Cohort B: post-liver transplant, with or without cirrhosis;
~Group assignment within cohorts was based on severity of liver impairment at screening [or presence of disease for FCH groups];
~Randomization was 1:1 within groups to 12 or 24 weeks of treatment."
726861|NCT02010216||
726862|NCT02010203||
726863|NCT02010151||
726864|NCT02010021||
726865|NCT02009982||
726866|NCT02009930|5 withdrawn|
726867|NCT02009878|The study was conducted in 30 participants (29 received treatment) at 14 trial sites in 7 countries.|Participants with syndrome of inappropriate antidiuretic hormone secretion (SIADH) and a serum sodium concentration between 120 and 133 mmol/L were randomized to single doses of 3.75, 7.5, or 15 mg tolvaptan. Baseline pharmacodynamics (PD) was assessed for 24 hours predose. Pharmacokinetic (PK) and PD assessments were obtained 24 hours postdose.
726868|NCT02009865|The recruitment was planned at 43 sites, and in total, 162 were randomized in a 1:1 ratio to two treatment groups, Epanova (n=81) and Olive Oil (n=81). Randomization of subjects was stratified by two factors: 1. use of lipid-altering drugs (yes, no), and 2. Qualifying triglycerides values below or above 885 mg/dL.|In total, 379 subjects were screened from the 43 sites.
726869|NCT02009722||
726870|NCT02009696||
726871|NCT02009501|Recruitment began Nov 2013, with enrollment in Jan 2014 and trial conducted to Nov 2014. All patients were recruited from the outpatient vascular and wound care clinic at Mt Sinai St Luke's - Roosevelt Hospitals in New York City.|
726872|NCT02009163||
726873|NCT02009046|In Year 1 (2011-12), eight schools participated. Following the first year, one matched pair of schools dropped out due to school administration changes and a new matched pair of schools with similar student characteristics was added for Year 2 (2012-13). Thus, ten schools participated in intervention delivery over the study period.|1909 participants were enrolled.
726874|NCT02008942||
726875|NCT02008916|Patients were randomized to one of three treatment groups (1:1:1) and planned to be treated for 156 weeks. At Week 16, subjects who were randomized to placebo were re-randomized to secukinumab 150 mg or 300 mg. Patients were enrolled in 54 centers in Germany, Spain, United States, Czech Republic, Belgium, Greece, Mexico, Portugal, Russia and UK.|A screening period (SCR) running up to 10 weeks before randomization was used to assess eligibility.
726876|NCT02008890|A total of 337 patients were screened, and 237 of these patients completed the screening phase and were randomized to treatment.|At baseline patients were randomized at 61 study centers to one of the three treatment groups in a 1:1:1 ratio.
726877|NCT02008877||
726878|NCT02008773||
726879|NCT02008682|This trial was conducted at 25 sites in China.|Between screening and randomisation, eligible subjects were to continue their usual pre-trial metformin dose and dosing frequency.
726880|NCT02008617||
726881|NCT02008565||
726882|NCT02008526||
726883|NCT02008396|Subjects were recruited by printed or internet advertisements, referrals from other health-care practitioners, and word-of-mouth. Potential participants were people, aged 21 or older, with a confirmed diagnosis of autism. The study was conducted at Los Angeles Biomedical Research Institute in Torrance, CA between February 2014 and October 2017.|One participant was excluded for not meeting eligibility criteria within exclusion window for enrollment.
726884|NCT02008370||
726885|NCT02008318||This is a single-arm study (Galunisertib at 150 milligram [mg]); the Galunisertib at 80 mg was considered exploratory and only conducted in parallel with the main study, at one site in Spain.
726886|NCT02008227||Twelve hundred and twenty-five participants were randomized in the study and were considered the Secondary Population (SP), out of which first 850 randomized participants were considered the Primary Population (PP).
726887|NCT02008149||
726888|NCT02007954|The study enrolled patients diagnosed with unresectable hepatocellular carcinoma without prior locoregional therapy or concurrent anticancer therapy. Patients were enrolled from February 2014 to January 2015, with the last patient completing follow-up in August 2015.|
726889|NCT02007863||
726890|NCT02007720|"patient randomized : participants who signed ICF (876 participants)
~Full analyis set: participants who received at least one dose of study drug (870 participants)
~safety set (858 participtants): participants who received at least one dose of study drug and completed at least one post baseline assessment"|
726891|NCT02007577||
726892|NCT02007512||This was a phase 2, randomized, double blind, placebo-controlled study. The results disclosed in this draft were based on the data collected till 23 Sep 2016.
726893|NCT02007434|This study was performed at one investigational center in the United States (US).|
726894|NCT02007369||
726895|NCT02007291||
726896|NCT02007278||A total of 9 research centers participated in the study, from which 76 patients were screened for inclusion and exclusion criteria, obtaining 40 patients eligible for randomization
726897|NCT02007252||A total of 65 participants were randomized in a 1:1 ratio to one of the two treatment groups. One participant discontinued prior to taking any study medication. As such, the participant flow is based on 64 randomized participants.
726898|NCT02007200||
726899|NCT02007109||
726900|NCT02007096|Participants recruited from the Department of Surgery at The Mount Sinai Hospital between November 2012 and October 2014.|
726901|NCT02007070|Participants with non-small cell lung cancer (NSCLC) who were assessed as being programmed cell death ligand 1 (PD-L1) positive were recruited for this study.|Thirty-eight (38) participants were enrolled in this study. The data cut-off date for this results disclosure was 30 July 2017.
726902|NCT02006979||
726903|NCT02006927||
726904|NCT02006888|The first patient was enrolled into the study on 19 December 2013 and the last patient completed the study on 03 October 2014.|
726905|NCT02006836|"Dates of the recruitment period : 2013.1-2013.12, and there are two periods of the study. Case-control period: month 1- month 6, self-control period: month 7-month 12.
~Study participants were recruited from Tongji Hospital and local poster advertisements"|In diabetic group, patients had taken metformin or pioglitazone or only on life modification for at least 3 months. In diabetic 2 group, patients were hospitalized treated with insulin for at least 6 days.We matched each of the diabetic patients to a healthy control according to age, BMI, and gender in the case-control period.
726906|NCT02006758||
726907|NCT02006732|809 patients were randomised and treated.|
726908|NCT02006719||
726909|NCT02006706||
726910|NCT02006693||
726911|NCT02006667||
726912|NCT02006654||
726913|NCT02006641||
726914|NCT02006628||
726915|NCT02006576||
726916|NCT02006420||
726917|NCT02006407||
726918|NCT02006342||
726919|NCT02006264||
726920|NCT02006160||
726921|NCT02006121||Blinded treatment was administered over 12 weeks after which patients could choose to enrol in a 12-month open-label phase. Early switching to the open-label phase was permitted for lack of efficacy in the double-blind phase.
726922|NCT02006108||
726923|NCT02006056|Patients attending the Odette Cancer Centre, Toronto, Canada, who satisfy the eligibility criteria were considered for entry into the trial. The last patient was enrolled July 2014.|This prospective phase II trial enrolled patients from November 2013 to July 2014.
726924|NCT02005887||
726925|NCT02005692||
726926|NCT02005666||
726927|NCT02005627||
726928|NCT02005601||
726929|NCT02005562||
726930|NCT02005549||
726931|NCT02005536|Participants were enrolled from 02 December 2013 to 28 April 2014 at 4 Clinical trial centers in Japan.|A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. A subject with an exclusion criteria was later discovered and was excluded in the per-protocol analysis set.
726932|NCT02005510||
726933|NCT02005484||
726934|NCT02005471|A total of 489 participants were screened, out of which, 389 participants were enrolled into the study.|
726937|NCT02005354|70 patients were randomised, thirty five patients received TENS impulses at a strong but comfortable amplitude (intervention group) and 35 patients received TENS impulses just above the sensory threshold (control group)|
726938|NCT02005276||
726939|NCT02005250|Patients are enrolled consecutively, until maximum 200 participants are reached, or further enrollment is terminated on the decision by the sponsor.|
726940|NCT02005211|Healthy subjects, adult and elderly Japanese vlounteers, male and female (non-fertile); First patient enrolled 24 Dec 2013, last patient completed 29 Jul 2014|Single Japanese Centre: SAD Part 1: 24 young adult subjects in 3 cohorts of 8, 2 placebo and 6 active AZD3293 dose (15 mg, 50 mg, 150 mg); MAD Part 2:16 elderly subjects in 2 Cohorts of 8, randomized 2 placebo and 6 active dose AZD3293 (15 mg, 50 mg) - Only data on subjests enrolled into cohorts was included in the data base for reporting
726941|NCT02005029|Eighteen patients were screened for eligibility between April 2013 and June 2015 at the Virginia Commonwealth University Parkinson's and Movement Disorders Center.|10 of 18 participants were randomized. Of those not randomized, 7 did not meet eligibility criteria and 1 was withdrawn by the principal investigator prior to randomization due to noncompliance with the protocol.
726942|NCT02005016||
726943|NCT02004990||
726944|NCT02004977||
726945|NCT02004886|A total of 13 clinical sites were used in this study in the following countries: Austria, Germany, New Zealand, Russia, and the United States of America.|
726946|NCT02004873|The study enrolled 744 subjects at 56 centers in 19 countries worldwide between December 2013 and May 2015.|Of the 744 subjects enrolled, 19 exited from the study without attempting Micra implant (7 did not meet inclusion / exclusion criteria, 12 due to other miscellaneous reasons), 6 attempted Micra implant but were unsuccessful, and the remaining 719 subjects were successfully implanted with a Micra device.
726947|NCT02004847|All patient visits were conducted at the Department of Dermatology and Allergology, RWTH Aachen University Hospital. One hundred and twenty-nine patients were prescreened, 49 patients were screened and 47 enrolled in the study at the time of screening from October 2013 to June 2014.|Two patients were screening failures, so 47 actually started the study.
726948|NCT02004522||
726949|NCT02004366|Participants were recruited between February 2014 and October 2016. Patients who participated in the in-hospital study period were invited to enroll in the prospective outpatient study. Of 250 in-patient participants, 224 accepted enrollment into outpatient study.|Of the 295 subjects consented, there were 15 screen failures. 30 (out of remaining 280 patients) were excluded from participation: 11 patients stayed <24 hours, 1 patient received corticosteroids, and 18 patients didn't receive medication. Therefore, 250 patients started the study.
726950|NCT02004262|This study enrolled patients with previously treated metastatic pancreatic adenocarcinoma from 21 medical centers in the United States and Canada. The last patient completed the study in August 2016.|Participants screened over a 21-day period.
726951|NCT02004236||
726952|NCT02004158||
726953|NCT02004132||
726954|NCT02004093||
726955|NCT02003963|Overweight and obese adolescent girls were recruited for study participation. Participants were screened and enrolled at Pennington Biomedical Research Center. 200 adolescents expressed interest in the study.|
726956|NCT02003924|The study was conducted at 254 sites in 32 countries.|A protocol amendment was implemented to unblind all participants and those who were previously treated with placebo had an opportunity to receive open-label access to enzalutamide at the discretion of the investigator.
726957|NCT02003911||
726958|NCT02003898||
726959|NCT02003638||
726960|NCT02003625||One patient assigned to the GCSF + placebo arm withdrew consent prior to the start of treatment
726961|NCT02003573|It was originally planned to enter 127 patients into this trial; however, the development of volasertib was discontinued during the conduct of the study.|
726962|NCT02003534||
726963|NCT02003508|Participants were recruited from clinical and community sources across Australia over a period of four years (February 2014- December 2017), which represented two phases. Participants recruited in phase 1 (2014-2015) were ineligible for school-based HPV vaccination. Participants in Phase 2(2016-2017) were eligible for school-based HPV vaccination.|
726964|NCT02003404||All 17 participants wore all three barrier types on control area AND peristomal area NOT 34 participants in study only 17 participants in study.
726965|NCT02003391|Participants were recruited from 14 investigational centers located in Latin America, Australia, Russia, and Korea.|Of the 157 participants enrolled, 1 participant was exited as a screen failure. This reporting group includes all randomized participants (156).
726966|NCT02003365|This study took place at 3 centers across the United States. Enrollment took approximately 2 months.|Subjects were screened for eligibility within 14 days of being enrolled
726967|NCT02003352||
726968|NCT02003183||
726969|NCT02003053||
726970|NCT02003014|Participants took part in the study at 152 investigative sites in Japan from 23 February 2009 to 31 January 2012.|Participants with a historical diagnosis of type 2 diabetes mellitus who failed to respond adequately to treatment with biguanides were enrolled to receive pioglitazone 15 milligram (mg) - 30 mg for up to 12 months.
726971|NCT02002975|Participants took part in the study at 1203 investigative sites in Japan, from 16 October 2007 to 30 June 2013.|Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled to receive pioglitazone 15 milligram (mg) - 30 mg tablet, orally, once daily for up to 3 years.
726972|NCT02002936||
726973|NCT02002884|The study was conducted at 28 investigative sites in Mexico, Argentina, Russian federation, Ukraine, United States and Poland.|A total of 372 participants were screened, 351 participants were randomized and 350 participants were randomized and treated in the study. 331 participants completed the main period (MP) and moved to the open-label-extension period (OLEX) out of which 281 participants completed the OLEX period.
726974|NCT02002871|Date of first enrollment: 23.10.2013, University Clinic Aachen Date of LPLV: 17.02.2014|
726975|NCT02002832||
726976|NCT02002767|Participants were enrolled at study sites in United Stated and New Zealand. The first participant was screened on 16 December 2013. The last study visit occurred on 09 June 2014.|46 participants were screened.
726977|NCT02002702|The study was conducted at 15 centers in Japan.|
726978|NCT02002689|The study was closed for accrual when the sponsor realized that not enough patients will be recruited for any meaningful stat analysis even if the study were kept open beyond the original planned accrual window.|
726979|NCT02002650|From Dec 15, 2013 to Sep 21, 2015, 5325 consecutive patients undergoing ERCP in six centers in China were considered for the study.|After screening, 2725 patients were excluded: 193 did not meet inclusion criteria, 2304 met exclusion criteria and 228 patients declined to participate.
726980|NCT02002533||
726981|NCT02002494||Twenty-seven volunteers were included in this study.
726982|NCT02002221||
726983|NCT02002208|142 patients were randomised. One patient withdrew prior to dosing meaning that there was 141 patients in the safety set. 2 further patients withdrew prior to the first efficacy measurement which means there were 139 patients in the full analysis set.|
726984|NCT02002182||
726985|NCT02002091|327 patients aged from 40 to 70 years were seen from 2009 to 2013. The main investigator confirmed the diagnosis of type 2 diabetes. A secondary diabetes was excluded before definitive recruitment. When the diagnosis of type 2 diabetes is highly probable and ensure that it was newly diagnosed, we screened for all chronic complications.|
726986|NCT02001987|A total of 183 participants were screened; 139 participants were eligible for the study and assigned to study treatment.|Analyses of primary/ secondary outcome measures were planned and performed in different analysis populations described in respective analysis population descriptions. Analyses of few secondary outcome measures and adverse events were planned and performed according to predefined subgroup populations and have been presented accordingly.
726987|NCT02001714|Recruitment letters were mailed to women 55 years and older seeking women with urinary incontinence who were treatment naïve. Those that met preliminary screening criteria, done at the administrative site, were referred to one of the three clinical sites (Alabama, Michigan or Pennsylvania) for final screening and enrollment .|
726988|NCT02001688|"There were 2 clinical sites. At each site, 18 subjects were recruited and randomized 2:1 to receive either Kamada-AAT for Inhalation 80 mg/day (site 1) or 160 mg/day (site 2) or placebo. This gave a total of 12 patients randomized to receive 80 mg/day active drug, 12 patients randomized to receive 160 mg/day active drug, and 12 patients placebo"|There were no pre-assignment changes
726989|NCT02001558||
726990|NCT02001194||
726991|NCT02001181|Eligibility included male or female participants, 18 to 60 years of age (inclusive), who had a clinical diagnosis of atopic dermatitis for at least 6 months and clinically stable for >=1 month.|During the screening/washout period, participants' current therapies (topical, systemic, and phototherapy) for atopic dermatitis were discontinued and only non-medicated study emollient, sunscreen topical products, and specific shampoos (for atopic dermatitis on hair-bearing scalp) were permitted.
726992|NCT02001051||One participant was enrolled to the delayed operative arm but did not complete. The participant did not have biochemical evidence of subclinical Cushing's and therefore was not eligible.
726993|NCT02000973||
726994|NCT02000921||
726995|NCT02000908||
726996|NCT02000817|The study was a multi-centered, single-blind, randomized, placebo-controlled 6 Day repeat dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and immunological profile of intravenously administered Otelixizumab (OTX) in New Onset Type 1 Diabetes Mellitus participants.|A total of 30 participants were enrolled at different centers in Belgium, which was conducted from 12-Mar-2014 to 27-Sep-2018.
726997|NCT02000752|Three midwives responsible for conducting the study were trained in the acupuncture technique during a 3 hour seminar. None of the 3 acupuncture-trained midwives were responsible for the management of labor, birth, or the third stage of labor. The midwife responsible for the birth measured the duration of the third stage of labor in minutes.|Inclusion criteria included: primiparous, aged between 20 and 35 years, at 37 to 42 weeks gestation with a low risk labor, receiving epidural analgesia. All criteria were chosen to homogenize the sample and minimize the number of excluded women.
726998|NCT02000622|The first patient was enrolled on 27 March 2014 and the last patient on 30 October 2015. Patients were randomized at 125 centres across 19 countries in North America, South America, Europe and Asia.|Screening occurred in 2 parts. Part 1: patients with unknown BRCA status were tested by Myriad. Part 1 screening failures were mostly due to no BRCA1/2 mutation detected. Part 2: patients with a known germline BRCA mutation were screened. 302 patients were randomized.
726999|NCT02000583||
727000|NCT02000531||
727001|NCT02000440|This single-arm, multicenter, fixed sequence open-label study consisted of 2 screening visits, run-in phase before the first dose of study treatment, followed by treatment phase in which participants received losmapimod 7.5 milligrams (mg) twice daily (BID) for 2 weeks and 15 mg BID for an additional 22 weeks, and a follow-up visit (12 weeks).|A total of 29 participants were screened and entered into the run-in phase, of which 17 participants received at least one dose of losmapimod.
727002|NCT02000427|"This study was conducted at 19 centers in 4 European countries and the United States: 3 centers in France, 3 in Germany, 5 in Italy, 1 in the United Kingdom, and 7 in the United States.
~The first participant enrolled on 03 January 2014 and the last participant enrolled on 12 January 2015."|Results are reported as of the data cut-off date of 20 May 2015.
727003|NCT02000180||
727004|NCT02000154||
727005|NCT01999985|25 participants were enrolled at Moffitt Cancer Center from December 2013 to March 2016.|
727006|NCT01999972|This study was conducted in 2 parts: Part 1 (Dose escalation part to determine maximum tolerated dose [MTD] of axitinib in combination with crizotinib), Part 2 (Dose expansion part to assess the safety and tolerability of axitinib in combination with crizotinib at MTD determined in Part 1).|To understand the pharmacokinetic (PK) effects of crizotinib on axitinib, a 7-day lead-in period of single-agent axitinib directly preceding the administration of the crizotinib and axitinib combination was included prior to Cycle 1 in the dose escalation phase of the study.
727007|NCT01999946||
727008|NCT01999920||
727091|NCT01994746|77 Type 1 (T1D) and 6 Type 2 diabetes (T2D) participants were recruited. Results reported include T1D participants only since this was the pre-specified primary population.|
727138|NCT01991483||This study included three parts. Part A was dose escalation (placebo, 300, 600, or 1,000 milligrams [mg] LY2928057). Part B was dose expansion (placebo or 1000 mg LY2928057). Part C was optional, based on predefined pharmacodynamics criteria. Part C was not executed.
727009|NCT01999894|Patients who completed the lead-in study MEM-MD-57A (NCT00872898) were eligible to enroll in this study. A total of 19 study centers in the United States enrolled patients.|Patients receiving placebo in the lead-in study underwent a double-blind up-titration targeting same weight-based dose assigned at lead-in study. Patients receiving a stable dose of active were not re-titrated but double-blind was maintained. Patients who were not dosed for more than 3 days between the studies underwent an open-label titration.
727010|NCT01999868|148 participants were screened and 108 of those participants were enrolled at 8 sites in the US and 2 sites in Canada between March 2014 and April 2016|Enrolled participants received open-label ustekinumab in the lead-in phase (Week 0 to 12). Participants with at least 75% reduction in Psoriasis Area Severity Index (PASI) score at Week 12 compared to Week 0 were eligible for the blinded treatment phase (Week 12 to 40).
727011|NCT01999777||188 eligible subjects entered Pretreatment Observation during which they were monitored in EMU for seizure events. Only subjects who met entry criteria and presented with seizure events meeting the treatment decision criteria were eligible to enter the Treatment Phase. Participant flow represents subjects who took at least 1 dose of study drug.
727012|NCT01999530||
727013|NCT01999517||
727014|NCT01999465||
727015|NCT01999400||
727016|NCT01999348||
727017|NCT01999322|The trial was conducted at two sites in two countries as follows: USA: one site; Germany: one site.|Eligible subjects previously treated with a rapid acting insulin analogue were to stay on their own NovoRapid®, insulin lispro or insulin glulisine in the screening period after which the all subjects received NovoRapid®, with no additional antidiabetics allowed, for a 2-week run-in period prior to randomisation.
727018|NCT01999231|In September 4, 2013, the recruitment carried out in Shanghai Public Health Clinical Center.|
727019|NCT01999218|The trial was conducted in 16 countries at 232 trial centers in Argentina, Canada, Czech Republic, Hungary, South Korea, Lithuania, Mexico, Philippines, Poland, Romania, Russia, Slovakia, South Africa, Taiwan, Ukraine, and the United States.|A total of 1326 participants were randomized. Ten randomized participants from one trial site were excluded from all final analyses (Week 104 and beyond), and one randomized participant did not receive treatment.
727020|NCT01999192||
727021|NCT01999114|First Subject First Visit: 15-March-2012; Last Subject Last Visit: 10-October-2012. The study was conducted at 1 medical/research site in the United States.|Healthy adult subjects
727022|NCT01998984|Participants were followed for 8 weeks following the first application of investigational medicinal product (IMP) at Day 1 (4-day treatment period including an 8-week follow-up period).|266 participants were enrolled of which 224 participants were randomized to treatment
727023|NCT01998958||
727024|NCT01998919||
727025|NCT01998906||
727026|NCT01998893||
727027|NCT01998880|787 patients were enrolled in the study. Following a 6 patient safety run-in prior to randomization, 781 patients were randomized.|589 patients were randomized to 1 of 3 treatment groups in 2:2:1 ratio: GClb (n=238), RClb (n=233) or Clb (n=118) in Stage 1 plus 192 randomized to GClb or RClb in Stage 2 [NCT02053610]. Stage 1 was divided for analysis into: Stage 1a [NCT01010061] (GClb vs Clb) reported separately and Stage 1b [NCT01998880] (RClb vs Clb) (n=351) reported here.
727028|NCT01998737||
727029|NCT01998633||
727030|NCT01998581||
727031|NCT01998477|Subjects were recruited from 12 centers in Spain and 4 centers from Italy.|All enrolled subjects were included in the trial.
727032|NCT01998438||
727033|NCT01998399||
727034|NCT01998360||
727035|NCT01998269|A total of 210 patients were recruited from the University of North Carolina Ambulatory Care Center. 17 patients participated in focus groups to help develop the medication self-management tool (MeDS tool). The other 193 participated in item performance testing. The results of item performance testing are reported here.|
727036|NCT01998243|151 patients were eligibles for the study and were evaluated at the endocrinologist office|40 patients rejected to be included in the study and 30 were excluded before randomization for not to fulfill all the established requirement to be included
727037|NCT01997905|The first subject was enrolled (defined as signed informed consent) on March 25, 2014. The last subject completed their final visit as of July 31, 2015. A total of 13 subjects were enrolled from 4 sites. Of the 13 enrolled subjects, 10 were treated (defined as attempted surgery) with the investigational device.|
727038|NCT01997892|First patient enrolled 28 August 2012; Last patient enrolled 3 July 2013.|
727039|NCT01997723||
727040|NCT01997567||
727041|NCT01997515||
727042|NCT01997437|The dates of the recruitment period are from June 2012 to January 2014. The recruitment process have been done in medical clinic: Krasnodar Regional Hospital #1.|
727043|NCT01997411||
727044|NCT01997398|All consecutive Parkinson's disease (PD) patients undergoing bilateral GPi deep brain stimulation surgery (DBS) under general anesthesia from May, 2012 - November of 2013.|Patients with advanced Parkinson's disease eligible for deep brain stimulation (DBS) surgery
727045|NCT01997333||1531 patients screened to randomize 327 patients. Most common reasons for screen failure were tumor tissue inadequate/gpNMB negative (697), failure to meet other eligibility (256) and refused to participate (77).
727046|NCT01997281||
727047|NCT01997229||
727048|NCT01997216|Participants were recruited from 1 study center located in the United States.|Of the 42 participants enrolled, 1 participant was exited as a screen failure and 1 participant was discontinued due to product unavailability prior to study product exposure. This reporting group includes all enrolled participants exposed to study product (40).
727049|NCT01996982||No data, beyond protocol enrollment number, are available for this study as the Principal Investigator (PI) has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, however, no data are available
727050|NCT01996917||21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm.
727136|NCT01991548||
727137|NCT01991522||
727139|NCT01991470||Two phase study: Enlite and Enlite 3. Some participated only Enlite phase and some only participated in Enlite 3 phase.
727051|NCT01996904|"March 2009 to October 2010
~Out-patient department
~Consecutive patients diagnosed with full thickness supraspinatus tear preoperative thru MRI
~Underwent arthroscopic repair or debridement for rotator cuff tear"|"A total of 256 patients were initially identified to have subscapularis tear. They were then enrolled and all randomized. By the twenty-fourth month outcome assessment and ultrasound evaluation, 65 were lost to follow-up. 38 from group A and 27 from group B. Thus, only 191 patients making the final number of participants.
~."
727052|NCT01996852||
727053|NCT01996839|The 2 vehicle arms were combined into 1 treatment group in the statistical analysis, and hence the study has 3 treatment groups (ie, Loteprednol Etabonate Gel TID, Loteprednol Etabonate Gel BID, and [combined] vehicle groups).|
727054|NCT01996826||
727055|NCT01996813|For the prospective case cohort, 23 participants were recruited from December 2013 through May 2014 (6 months) from a tertiary care practice. The remaining 24 participants were historical control participants|
727056|NCT01996748||
727057|NCT01996709|Subjects were recruited from 12 study centers located in the US.|Of the 142 enrolled, 8 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
727058|NCT01996657||
727059|NCT01996644||47 participants were enrolled in the study, but only 36 were randomized and given any medication or placebo (i.e., participants completed the assessment portion of the study but did not move to the active experimental portion of the study).
727060|NCT01996592|Elective cesarean section patients >/= 18 years of age who agree to be contacted for 8 weeks after delivery to obtain pain scores|
727061|NCT01996410||
727062|NCT01996332||Three cohorts were established in participants with advanced non-small cell lung cancer (NSCLC) based on previous chemotherapy treatment received: first line of treatment (where conventional chemotherapy is not indicated), second line of treatment, and third and subsequent lines of treatment. Inclusion was competitive.
727063|NCT01996319||
727064|NCT01996254|Recruitment began in 10-2013 (with the first subject enrolling 12-2013) and was concluded in 05-2018. Subjects were screened from a pool of candidates experiencing chronic post-amputation pain.|Participants in the Initial Study Design Arm were only assessed for Safety (Adverse Events).
727065|NCT01996241|80 of 121 village clusters in Vijayapura and Bagalkote districts, Karnataka State, were randomly selected (40 intervention; 40 control). Girls were recruited from two successive academic years (cohorts 1 and 2) to increase study power and achieve required sample size. Analysis was planned by trial arm rather than separately for two study cohorts.|
727066|NCT01996033||
727067|NCT01995838|Participants took part in the study at 23 investigative sites in the United States from 13 Nov 2013 to 29 Apr 2014.|A total of 616 participants were screened, of which 325 were screen failures and 291 were randomized to receive study treatment.
727068|NCT01995825||
727069|NCT01995552|The study enrolled acute post MI patients with a reduced LVEF (≤35%) one day before or on the day of discharge from hospital after index MI. There is no control group in this study. The study was conducted in India and in multi specialty hospitals|The first patient was enrolled on April 29, 2014. Enrollment continued until the 250th patient was enrolled on January 31, 2016. out of 250, patients, there were 233 patients in the analysis cohort, with at least 72 hours of monitoring documented in the ELR device data or a clinically significant arrhythmia in the first 72 hours of monitoring.
727070|NCT01995539||
727071|NCT01995526||
727072|NCT01995513||The study comprised of consecutive periods of open-label treatment with enzalutamide (period 1) followed by randomized, double-blind treatment with enzalutamide or placebo, each in combination with open-label abiraterone and prednisone (period 2).
727073|NCT01995461||
727074|NCT01995357||
727075|NCT01995266||Of 218 participants enrolled, 159 were treated. Of the 59 who were not treated, 55 did not meet study criteria and 4 withdrew consent to participate.
727076|NCT01995201||
727077|NCT01995175|2409 subjects were enrolled into the current primary study, which included subjects from birth to 2 years of age. This study will be further extended to follow-up subjects up to 6 years of age (extension study). Results presented in this record correspond to the primary study and will be updated with the results of the extension study.|Out of the 2409 subjects enrolled initially, 7 subjects did not sign the re-consent for study participation after delivery (birth), leaving 2402 subjects to be enrolled into the Total enrolled cohort. 1 subject was excluded due to protocol violation, hence 2401 subjects formed the Per Protocol Set (PPS).
727078|NCT01995136|Subjects were recruited from 5 study sites located in Japan.|This reporting group includes all enrolled subjects (32).
727079|NCT01995123||
727080|NCT01995071||
727081|NCT01995045|Participants were recruited from Emory University Hospital between October 1, 2012 and June 17, 2016 who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both.|Of the 58 participants recruited for the study, data for 57 participants were analyzed. Data for one participant was not available for analysis.
727082|NCT01994993||One participant was enrolled but did not receive any dose of study drug. The participant is excluded from study result data analysis
727083|NCT01994954|Eligible patients were screened from November 2013 to December 2017. Subjects were screened either before NICU discharge with anticipation of HOT therapy or at their first pulmonary clinic visit. Each subject was consented at their first outpatient pulmonary clinic or NICU follow-up clinic with a pulmonary component.|
727084|NCT01994902||129 subjects were randomized, but two of these subjects were not exposed to a product: one subject had a stoma diameter of 42 mm (violation to inclusion criteria no.8) and one subject had chemotherapy planned (exclusion criteria no.3). 127 subjects were therefore included in the ITT population.
727085|NCT01994889||Pooled analysis of the tafamidis treatment groups [20 milligrams (mg) and 80 mg] was performed in comparison to placebo group.
727086|NCT01994876|The subject were recruited through the Coloplast database in The Netherlands|
727087|NCT01994863||"Not completed includes those who did not complete the entire period (those that did not try all products within the period) and then continued to next period, if relevant."
727088|NCT01994850||
727089|NCT01994837||All participants who received at least 1 dose of study drug
727090|NCT01994785||
727092|NCT01994720|In total, 13307 patients were enrolled from 674 study sites in 33 countries. The first patient was enrolled on 07 January 2014. The last patient visit took place on 02 March 2016.|Enrolled patients randomised to study drug: 99.2%; n=13199 Patients who were not randomised: 0.8%; n=108 Patients with eligibility criteria not fulfilled: 0.7%; n=93 Patient decision: 0.1%; n=15
727093|NCT01994629|Subjects were enrolled from 4 centers in Italy.|All enrolled subjects were included in the trial.
727094|NCT01994590||
727095|NCT01994538|Enrolled subjects are afebrile men with symptomatic urinary tract infection who were initially treated with 7-14 days of trimethoprim/sulfamethoxazole (TMP/SMZ) or ciprofloxacin by the treating clinician. Subjects were randomized prior to day 8 of treatment to an additional 7 days of their original study drug (14d group) or placebo (7d group.|"Primary analysis was per-protocol, and included all subjects who took at least 26 of 28 doses of medication.
~Intention to treat analysis includes all randomized subjects."
727096|NCT01994486||
727097|NCT01994395||
727098|NCT01994291||In total, 199 participants were randomized, with 99 randomized to receive PF 04634817 200 mg and 99 to placebo + ranibizumab 0.3/0.5 mg. One participant was randomized but discontinued prior to dosing as no longer willing to participate.
727099|NCT01994226||
727100|NCT01994109|The study was conducted at 33 sites including United States, Russia and Ukraine.|DB: Double Blind (Part A) OL: Open Label (Part B)
727101|NCT01993940|Participants were randomized at 69 sites in North America and Europe, including Austria, Czech Republic, Germany, Poland, Spain, and the United States.|"Participants were randomized in a 1:1 ratio to 0.2 mg naldemedine or placebo for 12 weeks. Randomization was stratified based on documented opioid use (average total daily dose (TDD) during the 14-consecutive-day qualifying period) as follows:
~30 to 100 mg equivalents of oral morphine sulfate
~> 100 mg equivalents of oral morphine sulfate"
727102|NCT01993927|Participants took part in the study at 130 investigative sites in Japan, from 18-November-2009 to 31-August-2013.|Participants, who had determined as having impaired glucose tolerance (IGT) without improvement despite treatment with diet therapy and exercise therapy for 3-6 months, were enrolled to receive voglibose 0.2 milligram (mg) orally, three times daily, up to 72 months (approximately 1 year and 6 months).
727103|NCT01993888||
727104|NCT01993875||
727105|NCT01993849||
727106|NCT01993836||
727107|NCT01993823|ENT Mexican sites|
727108|NCT01993667||
727109|NCT01993615|Recruitment occurred from the orthopaedic clinic at Madigan Army Medical Center|
727110|NCT01993238||
727111|NCT01993186||Beginning with the Screening visit, participants recorded seizure frequency during a 6-week Baseline Period. If the participant did not meet the seizure count criteria, the participant was considered a screen failure and was not randomized.
727112|NCT01993108||
727113|NCT01993030||
727114|NCT01993017|"Recruitment period: November 1, 2013 to March 31, 2017
~Recruitment sites: HealthPartners (Minneapolis, Minnesota), Duke University Health System (Durham, North Carolina), Kaiser Permanente Northwest (Portland, Oregon), and New York-Presbyterian/Columbia University Irving Medical Center (New York, New York)"|1 participant withdrew consent soon after randomization, and this participant's data was excluded from the study.
727115|NCT01992874|First/last subject (informed consent): Nov 2013/Feb 2015. Clinical data cut-off: May 2014, Study completion date: Feb 2015|A total of 45 subjects were screened. 38 subjects were enrolled and received the trial medication completed two sequence cross-over Part A and further continued in open label Part B.
727116|NCT01992757||
727117|NCT01992653|The study was conducted at 11 centers in 2 countries.|A total of 85 participants were enrolled at 11 centers in the following countries: France (31 participants) and United States (54 participants). 3 participants did not receive any study treatment (2 had exclusionary lab values and 1 withdrew) meaning that the safety population consisted of 82 participants.
727118|NCT01992549||
727119|NCT01992536|Subjects were recruited from 5 study sites in Poland and from 8 study sites in United States.|All enrolled subjects were included in the study.
727120|NCT01992523||
727121|NCT01992380|Enrollment between Nov 2013 and May 2014|
727122|NCT01992354||
727123|NCT01992185||
727124|NCT01992172||
727125|NCT01992159|This study was conducted at 24 centers in Japan. The first participant was enrolled on 12 October 2012 and the last participant enrolled on 15 October 2013.|Participants were randomized in a 1:1:1:1 ratio to receive placebo or romosozumab 70, 140, or 210 mg subcutaneous (SC) injection every month (QM) for 12 months. Upon completion of the 12-month treatment period, participants were followed for another 3 months for assessment of antiromosozumab antibody formation (follow-up period).
727126|NCT01992107|Subjects were recruited from 90 centers in the United States (US)|All enrolled subjects were included in the trial
727127|NCT01992094|Subjects were enrolled from 40 centers in US|All enrolled subjects were included in the trial
727128|NCT01992016||
727129|NCT01991990||The screening visit was up to 3 weeks before randomization to the first dose of study medication. Out of 23 screened participants; 5 participants discontinued (4=met exclusion criteria; 1=withdrew), 18 participants were included.
727130|NCT01991977||
727131|NCT01991860||Of the 364 patients enrolled in the study (i.e. signed informed consent form), 22 patients were not randomised and not dosed. Of these, 4 withdrew their consent, 3 did not comply with the protocol procedures and 15 were not dosed for other unspecified reasons.
727132|NCT01991821||Of the 368 patients enrolled in the study, 21 patients were not randomised and not dosed. Of these, 3 withdrew their consent, 5 did not comply with the protocol procedures and 13 were not dosed for other unspecified reasons.
727133|NCT01991808||
727134|NCT01991795|1315 study sites in 42 countries enrolled patients. The first patient was enrolled on 10 February 2014. The last patient visit took place on 25 January 2019.|Enrolled patients randomised to study drug 95.8%; n =19271, of which 51 patients were randomised to study drug at a site prematurely closed by sponsor and excluded from the study results. Patients who were not randomised 4.2%; n=837. Patient did not meet inclusion/exclusion criteria n=454, Patient decision n=256, Death n=1, Other reason n=131.
727135|NCT01991743|A total of 240 patients were enrolled and allocated to one of four bupivicaine dose groups|
727140|NCT01991314|Between January 2012 and April 2015; adult and paediatric IBD clinics at Barts and the Royal London Hospitals, or the paediatric IBD clinic at Chelsea and Westminster NHS Trust, London, UK, w|After trial closure, 1 adult (transferrin saturation 22%) and 1 adolescent (Hb 12.0) were found to have been recruited in error and were excluded from further analysis, leaving 88 participants in total.
727141|NCT01991197|From April 25 2014 to April 22 2015 20 participants were recruited from Dermatology and Endocrinology outpatient clinics and through national newspaper advertisements.|
727142|NCT01991067||
727143|NCT01990898||
727144|NCT01990859|Study initiated 12 December 2013 and completed February 2015. Previously treated or untreated patients with Stage III (unresectable) or Stage IV melanoma were recruited. Previously untreated defined as: patients without treatment for metastatic disease but who may have received treatment in the adjuvant setting.|26 participants were enrolled and 20 were treated with study drug. Of the 6 participants not treated: 5 no longer met study criteria, 1 withdrew consent.
727145|NCT01990820||4 participants were enrolled on incorrect consent forms so their data were not collected. The IRB provided approval to enroll additional patients to make up for these 4 patients.
727146|NCT01990794||
727147|NCT01990768|Between May 2015 and March 2017, participants were enrolled by 39 emergency management service (EMS) agencies and transported to 20 trauma centers within 12 regional sites in North America.|Some persons for whom the blinded study kit was opened did not actually receive any of the study drug. These persons are not included in the enrollment numbers. However, they are enumerated in the first section of the patient flow tables.
727148|NCT01990742||Nursing Homes, not individual participants, were enrolled in this RCT study, and were the unit of intervention. However, the outcomes analysis was performed on decedents who were cared for in the enrolled Nursing Homes.
727149|NCT01990703||
727150|NCT01990677||Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.
727151|NCT01990664||A total of 199 subjects were enrolled in the study; 7 subjects were enrolled but not randomized. 18 subjects were discontinued and 174 subjects completed the study. Of those 174 completed subjects, 5 subjects had major protocol deviations; 169 subjects were included in the analysis.
727152|NCT01990612|50,581 low-risk nulliparous women at 34 weeks 0 days gestation to 38 weeks 6 days gestation were screened for eligibility between March 2014 and August 2017 at 41 hospitals participating in the MFMU network. Women who consented were assessed again between 38 weeks 0 days gestation and 38 weeks 6 days gestation for new indications of ineligibility.|
727153|NCT01990573||"53 signed consents however, 2 participants withdrew prior to randomization:
~1 per family request
~1 unable to complete"
727154|NCT01990560||
727155|NCT01990534|Participants took part in the study at 18 investigative sites in Czech Republic, Germany, Malaysia, Poland, Spain, Thailand and Turkey, from 14 March 2014 to data cutoff: 24 March 2016. [24 Months]. Study is ongoing for overall survival.|Participants with a diagnosis of relapsed or refractory Hodgkin Lymphoma were enrolled in 1 treatment group, brentuximab vedotin 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of every 3-week cycle.
727156|NCT01990339|Participants were enrolled in the study during the period between December 8, 2008 and June 30, 2010.|Participants enrolled in the study were clinically diagnosed with reflux esophagitis or non-erosive gastroesophageal reflux disease.
727157|NCT01990313||
727158|NCT01990300|Participants took part in the study at 445 investigative sites in Japan, from 28 November 2011 to 31 March 2015.|Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled to receive Alogliptin/Pioglitazone 25 milligram (mg)/ 15 mg or 25 mg / 30 mg combination tablet orally, once daily for up to 12 months.
727159|NCT01990261|A total of 33 participants were enrolled in 13 centers in Romania.|
727160|NCT01989975||
727161|NCT01989910||
727162|NCT01989793||
727163|NCT01989754||A total of 5,813 participants were randomized. However, 1 participant was randomized twice and only the first randomization was included in the Intent-to-treat (ITT) analysis set. Thus 2,905 and 2,907 participants were randomly assigned to the placebo and canagliflozin groups in the ITT analysis set, respectively.
727164|NCT01989689|Patients recruited from clinic sites at Emory University Hospital and by advertisements between January 2011 through April 2013.|
727165|NCT01989676|A total of 707 subjects were randomized to the study. Of these, 5 patients were randomized but did not receive study drug.|Participants who fulfilled the inclusion/exclusion criteria were randomly assigned to 1 of the 2 treatments of this study.
727166|NCT01989572|The study was open between December 29, 1999 and October 31, 2006. A total of 815 patients were enrolled.|
727167|NCT01989468|Patients were randomized to 1 of 3 treatment arms (1:1:1) and planned to be treated for 156 weeks. Placebo non-responders had the option to be re-randomized at Week 16 and placebo responders had the option to be re-randomized at Week 24. Thus, of the 137 original placebo patients 64 were re-randomized to AIN457 150 mg and 65 to AIN457 300 mg.|A screening period (SCR) running up to 10 weeks before randomization was used to assess eligibility.
727168|NCT01989455||
727169|NCT01989208||
727170|NCT01989195||
727171|NCT01989169||
727172|NCT01989156|"Study initiated (first subject screened): 17 December 2013
~At admission (Day -2), all the subjects performed a product trial of THS 2.2 Menthol. During the baseline period, they continued to smoke their single preferred brand of mCC. Then, on Day 0, they were randomized to one of the 3 study arms (mTHS 2.2, mCC or SA) in a 2:1:1 ratio."|"Enrolled and randomized population = 160 subjects
~80 subjects in mTHS 2.2
~41 subjects in mCC
~39 subjects in SA
~Number of subjects exposed to the product test = 165
~Number of subjects enrolled but NOT randomized = 4
~Number of subjects failed screening = 1"
727173|NCT01989130||
727174|NCT01988922||
727175|NCT01988857|Out of the 302 subjects enrolled into the study, 2 were excluded due to developing allergic reactions and hence only 300 started the study.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
727176|NCT01988779||8 participants screen failed before randomization to the intervention.
727177|NCT01988662|All randomized patients were included in the Full Analysis Set (FAS).|
727178|NCT01988493|First participant enrolled 06 Jan 2014. Clinical data cut-off:12 Mar 2018.|A total of 27 participants were enrolled in Phase 1b part of the study and a total of 90 participants were enrolled in phase 2 part of the study. Participants enrolled in phase 1b were not eligible for randomization in phase 2.
727179|NCT01988415||
727180|NCT01988402||35 patients were enrolled which achieved a completer number of 31. This was one short of the original completer target of 32. Power analysis suggested that a much larger number would have been required to achieve statistical power, and that enrolling 1-2 more subjects would not have contributed to the data.
727181|NCT01988376||
727182|NCT01988246||
727183|NCT01988129|We invited 73 departments to consider participating based on size and workload, and received 32 responses. Based on interview, selection was based on department cooperation, the practicalities of initiating the program, and the availability of departmental measures for analysis. We selected a mid-sized fire department with ~1200 firefighters.|32 fire department stations were paired according to the previous calendar years' workload. One station from each pair (16 stations) was randomly assigned to receive the program. All personnel from the intervention stations were instructed to attend scheduled education sessions.
727184|NCT01988103|Participants must have had a diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening and which was considered inappropriate for topical therapy (e.g, based on the severity of the disease and extent of affected area) or could not be adequately controlled/treated with topical therapy to qualify for the study.|Treatment assignments were stratified according to whether the participants had a psoriatic arthritis (PsA) diagnosis by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (yes/no) at screening, whether they participated in the sparse pharmacokinetic (PK) sampling, and whether they had participated in the intensive PK sampling.
727185|NCT01988090||
727186|NCT01988012||
727187|NCT01987986||
727188|NCT01987960|417 patients were enrolled to the study and 413 patients received open-label treatment with a commercially available treatment for PTSD (PAR/SER) in Period 1. Only 40 patients were randomized to Period 2, the randomized period, before the study was terminated; 190 patients entered Period 3. Data are only reported for the randomized period.|
727189|NCT01987908|Enrollment was conducted at one clinical site in the United Kingdom with referrals and/or patient identification from five other clinical sites in the United Kingdom.|35 participants were enrolled. 10 failed screen and 2 were randomization failures. 23 started the 2-week, single-blind, placebo lead-in period (to obtain stable baseline values and to screen out participants who did not tolerate placebo or were not compliant with study procedures).
727190|NCT01987895|904 patients at 70 sites in 12 countries were screened, among whom 632 were enrolled in the IMPACT 1 trial at 64 sites located in North & South America, Europe and Australia.|
727191|NCT01987830||
727192|NCT01987765||
727193|NCT01987752||
727194|NCT01987609||
727195|NCT01987596||
727196|NCT01987583||
727197|NCT01987557||
727198|NCT01987505||
727199|NCT01987479||A total of 174 participants were screened, out of which 150 participants met eligibility criteria and were enrolled into the study.
727200|NCT01987453|Participants were enrolled at study sites in the US, Australia, and Spain. The first participant was screened on 30 July 2014. The last study visit occurred on 12 November 2015.|101 participants were screened.
727201|NCT01987427|Participants took part in the study at 12 sites in the United States from 30 October 2013 to 03 September 2014.|A total of 344 participants were screened and enrolled, of which 106 were screen failures and 238 were randomized to receive study treatment, out of which 235 participants were treated.
727202|NCT01987414||
727203|NCT01987401||
727204|NCT01987349|Numbers listed in the tables reflect individual twins and not twin pairs.|
727205|NCT01987232|This study was conducted at 17 centers in the United States, Russia, and Canada.|In the phase 1b portion of the study participants were assigned sequentially to escalating doses of carfilzomib given in combination with standard dose carboplatin and etoposide to establish the maximum tolerated dose (MTD). The phase 2 portion of the study was not enrolled.
727206|NCT01987219|Fifteen patients with Familial Dysautonomia were enrolled into the study between March 2013 and December 2015. The study was conducted at the NYU Dsyautonomia Center and Israeli FD center.|
727207|NCT01987102|Patients were pre-screened for eligibility to participate by the principal investigator among those patients who have received confirmed diagnosis of osteosarcoma and were planned for surgical resection of their tumor in combination with neoadjuvant or adjuvant chemotherapy.|
727208|NCT01987089|83 was the anticipated recruitment target sample and our final recruitment sample was 63|
727209|NCT01986985||
727210|NCT01986946|17 participants consented in the study, 3 participants were not randomized in the study due to not having the surgery.|
727211|NCT01986920||In this study each patient is treated with all 4 treatments on 4 different lesions on their back. Therefore, each patient participates in each group so the total enrollment matches the number of lesions treated but not the total participants.
727212|NCT01986907|Patients were recruited from investigative sites located in Italy.|This reporting group includes all treated patients (one eye or both eyes)
727213|NCT01986855|The trial was conducted in 13 countries, including 171 trial centers; 1709 participants were screened and 468 were randomized.|"Eligible participants began a ≥10-week metformin wash-off during which participant's antihyperglycemic agents (AHAs) could be adjusted.
~All participants entered a 2-week placebo run-in period."
727214|NCT01986829|The study opened to participant enrollment on 02/03/2014 and closed to participant enrollment on 06/19/2017.|
727215|NCT01986790||
727216|NCT01986751||
727217|NCT01986686||
727218|NCT01986647|Recruitment occurred between April 2014 through January 2016. Potential participants were recruited from independent living facilities, senior apartment buildings, and senior community centers.|
727219|NCT01986361||133 patients were screened and 122 enrolled. Participants were randomly assigned in a 5:1 ratio to receive either an 8.75 mg flurbiprofen lozenge or a vehicle lozenge (placebo).
727220|NCT01986231||
727221|NCT01986140||
727234|NCT01985321|Subjects were recruited from the start of the study in November of 2013 until the completion of the study in March 2014. There were 8 Investigators at 8 clinical sites.|There were no notable events or approaches for the study following enrollment, but prior to group assignment. Once subjects were found to meet the eligibility requirements at the screening/randomization visit they were randomized 1:1 into the active or placebo treatment groups.
727235|NCT01985126||
727236|NCT01984892||
727237|NCT01984697||A total of 1536 participants were screened and 1518 were randomized into the study.
727238|NCT01984684||
727239|NCT01984515||
727240|NCT01984424|"A total of 511 participants were enrolled (492 in Part A and 19 directly in Part B) at 53 centers in the United States of America, Europe, Australia, New Zealand, Canada, and South Africa from December 2013 to November 2014.
~Results are reported for participants randomized in Part B. Part C was ongoing at the time of this analysis."|A total of 492 patients were randomized in part A; of those, 202 completed both periods and experienced muscle-related side effects during the atorvastatin period and not during the placebo period. Of the 202, 199 enrolled in Part B. Nineteen additional patients bypassed part A, as permitted by protocol, and advanced directly into part B.
727241|NCT01984398||
727242|NCT01984294|Participants were enrolled at a total of 1 study site in the United States. The first participant was screened on 29 October 2013. The last study visit occurred on 18 July 2014.|117 participants were screened.
727243|NCT01984242||Total 305 participants enrolled in this study. Participants enrolled in atezolizumab (except European Union [EU] participants) or sunitinib group could crossover to receive atezolizumab and bevacizumab combination therapy in case of disease progression. Some participants didn't complete due to study termination, but study was completed as planned.
727244|NCT01984229||
727245|NCT01983969|Patients enrolled at MD Anderson Clinic between November 2013 and May 2015.|
727246|NCT01983930|Single site outpatient clinic in the U.S.|168 volunteers were assessed for eligibility, of which 51 declined to participate and 32 did not meet inclusion criteria. Eighty-five volunteers consented to participate, of which 81 passed screening and were enrolled; two of 81 enrolled participants withdrew post-randomization and did not receive the allocated intervention.
727247|NCT01983878||Participant study completion was defined as participant assessment at the 12-week visit or withdrawal from the study.
727248|NCT01983839||
727249|NCT01983826||
727250|NCT01983787||
727251|NCT01983683|1128 patients at 105 sites in 15 countries were screened, among whom 631 were randomized at 96 sites in 14 countries worldwide.|Among the 631 subjects randomized, 22 were excluded from all the analyses due to potential data integrity issues resulting in 609 total participants considered for the analyses. From the 22 excluded patients no serious adverse events (AEs) or study drug discontinuation information were reported. All reported AEs were mild or moderate in intensity.
727252|NCT01983566|It was planned that 16 healthy Caucasian subjects (males and females, at least one third of each sex) and 16 healthy Japanese subjects (both males + females, at least one third of each sex) would enter the study. They were recruited from the volunteers' pool of the trial site. Due to early study termination, no Japanese subjects were randomised.|"All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that the subject met all strictly implemented inclusion/exclusion criteria.
~Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated."
727253|NCT01983553|Study participants were enrolled in the original study CYD23 (NCT00842530) from 10 September 2013 to 29 November 2013 at 1 clinic center in Thailand.|Of the 3997 participants who were treated in the original study CYD23, a total of 3203 participants were included in this CYD57 study to continue the 4-year safety follow-up.
727254|NCT01983293||The study enrolled 248 subjects, with 247 having an attempted implant. Of the 247 subjects with an attempted implant, three subjects were excluded from analysis based on having a LBBB morphology and two excluded based on QRS duration <120 ms.
727255|NCT01983254|417 participants were enrolled (277 patients and 140 informal caregivers). 261 participants were randomized (175 patients and 86 caregivers).|
727256|NCT01983111||
727257|NCT01983020||
727258|NCT01982955|First participant enrolled on 23 Dec 2013. Clinical data cut-off:12 Dec 2018.|A total of 18 participants were enrolled in Phase 1b part of the study and a total of 70 participants were enrolled in phase 2 part of the study. Participants enrolled in phase 1b were not eligible for randomization in phase 2.
727259|NCT01982942||
727260|NCT01982812|Randomized consecutive, eligible consented children with cerebral malaria during two recruitment periods--January to June 2014 and 2015,|
727261|NCT01982786||
727262|NCT01982773||
727263|NCT01982695||
727264|NCT01982682||
727265|NCT01982643||
727266|NCT01982539||
727267|NCT01982435||
727268|NCT01982383||
727269|NCT01982331||
727270|NCT01982292||A total of 323 patients were randomized to the serelaxin or placebo treatment in a 2:1 ratio. 2 patients from serelaxin were mis-randomized, hence 321 received study drug.
727271|NCT01982253|Participants took part in the study at 5 investigative sites in the United States from 21 October 2013 to 31 January 2014.|Participants with a historical diagnosis of type 2 diabetes mellitus and inadequate glycemic control on diet and exercise alone were enrolled in 1 of 3 treatment groups, placebo, fasiglifam 25 milligram (mg) twice daily (BID) and fasiglifam 50 mg once daily (QD).
727272|NCT01982240||The data are correct and approved in the NDA. 1394 randomized subj.including 69 (index and non-index) duplicate subj. The index subj (21) were duplicate appeared the first time in the study and the same subject appeared in other studies or sites were non-index duplicate (48) who were excluded in the ITT population (1346).
727273|NCT01982123||
727274|NCT01981967|The study participants were enrolled from 03 November 2013 to 08 February 2015 in 10 trial centers in Thailand.|A total of 10,000 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
727399|NCT01973569|A total of 679 participants who met all inclusion and none of the exclusion criteria were included in the study; efficacy outcomes were assessed in the Full Analysis Set (n=654).|
727275|NCT01981954|Children aged 6 months to < 5 years old with neurogenic detrusor overactivity (NDO) were enrolled from Belgium (1 site), United Kingdom (1 site), Poland (2 sites), United States (1 site), the Philippines (1 site) and South Korea (2 sites).|Children who met the eligibility criteria were treated with sequential doses of solifenacin up to 12 weeks to determine each participant's optimal dose, after which a fixed dose of solifenacin was given for at least 40 weeks. A washout period was required between screening and baseline if the children were being treated with antimuscarinic agents.
727276|NCT01981863||
727277|NCT01981772||
727278|NCT01981759||As the screening period lasts up to four weeks before the baseline visit and participants are not randomized until week 3, 59 participants were either screen failures or dropped out before randomization to treatment group.
727279|NCT01981616|Participants took part in the study at one investigative site in the United Kingdom from 13 September 2011 to 13 July 2012.|Healthy participants were randomized in a 1:1 ratio to receive a single dose of placebo or vedolizumab.
727280|NCT01981590|"15 subjects have been enrolled, in Sweden (Karolinska University Hospital, Solna in Stockholm) and in The Netherlands (Catherina Hospital in Eindhoven).
~All the 15 subjects enrolled underwent the study procedure and performed the 2-4 weeks post-procedure assessment follow-up"|
727281|NCT01981564||
727282|NCT01981551||
727283|NCT01981473|This is a multicenter, non-interventional (NI) study conducted to evaluate data collected from a cross sectional population of participants with rheumatoid arthritis (RA) who received treatment with etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.|Participants treated with one of the three targeted therapies were enrolled using interactive response technology to assure data for approximately 200 participants were included for each RA treatment.
727284|NCT01981356|We reviewed charts for 429 admissions over 8 months; 67 patients were approached because they potentially met study criteria|Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.
727285|NCT01981122||
727286|NCT01981109||
727287|NCT01981096||
727288|NCT01981057||
727289|NCT01980992|Enrollment began November 2013 and was completed in November 2014|
727290|NCT01980940||Participants were screened for inclusion in the study over 4 weeks prior to first treatment. Two additional participants were screened for Study Part 1 but not randomized or treated due to screen failure.
727291|NCT01980914||
727292|NCT01980888|Participants were enrolled at study sites in the North America, Australia, and Europe. The first participant was screened on 05 February 2014. The last study visit occurred on 16 June 2016.|392 participants were screened.
727293|NCT01980875|Participants were enrolled at study sites in Australia, Europe, and North America. The first participant was screened on 21 April 2015. The last study visit occurred on 13 May 2016.|80 participants were screened.
727294|NCT01980771||
727295|NCT01980706||
727296|NCT01980654||
727297|NCT01980628||
727298|NCT01980589|This study was conducted at 9 centers in the United States.|Eligible participants were enrolled into sequential dose-escalation cohorts consisting of 3 to 6 participants to establish the maximum tolerated dose (MTD) of carfilzomib when given in combination with cyclophosphamide and dexamethasone. Additional participants were enrolled in an expansion cohort at the established MTD to collect safety data.
727299|NCT01980524||
727300|NCT01980485||
727301|NCT01980342||
727302|NCT01980095||
727303|NCT01980056||
727304|NCT01979952|Patients were randomized to receive nintedanib or placebo in 1:1 ratio. After Global Amendment 1, study design was changed to exploratory, and duration of double blind, placebo-controlled part of study was reduced from 12 months to 6 months, followed by conversion of all patients to open-label nintedanib treatment for a duration of up to 18 months.|
727305|NCT01979835||
727306|NCT01979614|Out of the total 63 participants screened, 62 were randomized. 4 of the randomized participants did not receive study drug, and 58 did receive study drug|Of the 58 participants in the safety analysis set, 56 completed the treatment and follow-up period as planned (i.e. Day 30 and Day 180).
727307|NCT01979523||
727308|NCT01979445||
727309|NCT01979276||Two subjects were ineligible and therefore never started treatment.
727310|NCT01979185||
727311|NCT01979159||
727312|NCT01979133||
727313|NCT01979029|69 Chinese patients from the First Hospital of Jilin University were recruited for the study between February 2013 and December 2013 .|69 patients initially considered for the study, 11 were excluded because they didn't meet the including criteria. The remaining 58 patients were informed with regard to the study, but they remained blinded to the type of operative technique they would receive. Ultimately, one patient declined to participate in the study.
727314|NCT01979016|The study was conducted at 5 sites in USA and Canada between 05 December 2013 and 30 January 2015. A total of 66 participants were screened in the study.|Out of 66 participants, 54 participants were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive Dupilumab 200 mg once weekly (qw) or placebo qw.
727315|NCT01978938|Participants with a diagnosis of complicated urinary tract infection (cUTI), including participants with acute pyelonephritis, were recruited into this study.|Screening and baseline assessments were performed after informed consent was obtained and within 36 hours prior to enrollment.
727316|NCT01978912||
727317|NCT01978743||
727318|NCT01978600|Participants were recruited from 1 study center located in the US.|Of the 89 enrolled, 3 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (86).
727319|NCT01978535|Subjects were recruited at the Mayo Clinic, Rochester, Minnesota.|
727320|NCT01978509||
727321|NCT01978314||
727400|NCT01973491||37 subjects were enrolled in the study and entered the 8-week Baseline Control Period. Following completion of the Baseline Control Period, eligible subjects entered the 4-week Titration Period followed by a 16-week Treatment Period.
727322|NCT01978262|103 adult female subjects enrolled and 92 completed study over 3 vaccination seasons from 2013-2017. Each participant served as her own control and followed for 2 months: an Inactivated influenza vaccination (IIV) month and a observation/comparator month.|Study specific screening occurred prior to enrollment. 180 screens completed
727323|NCT01978236|Six participants (five male and one female) with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma to the brain were enrolled into the study, all into Cohort A. There were no participants enrolled in Cohort B.|
727324|NCT01978184||
727325|NCT01978145||A Total of 665 participants (par.) were enrolled into the study, 185 participants were screen failures and 53 participants were run-in failures. A total of 427 participants were randomized and 426 participants were included in Intent-to-Treat (ITT) Population.
727326|NCT01978119||Total 124 participants (par) were enrolled into the study, 33 participants were screen failures and 7 participants were run-in failures. A total of 84 participants were randomised and 82 participants were included in Intend to treat (ITT) population.
727327|NCT01978093|600 subjects were recruited from 27 centers in the United States. The study consists of 2 epochs: Epoch 001: starting at Day 0 and ending at the day preceding the 4th vaccination (Month 10-13) and Epoch 002: starting at Month 10-13 and ending at Month 17-20, 31 days after the 2nd Havrix vaccination|All enrolled subjects were included in the study.
727328|NCT01977937||
727329|NCT01977846||
727330|NCT01977820|First/Last subject (informed consent): 24 Feb 2014/12 Aug 2014. Study premature termination date: 07 Nov 2014; Subjects were randomized at 2 study centers.|A total of 10 subjects were screened and 7 subjects were included in the 2-Week response test period. Out of 7 subjects, only 2 subjects were responders and they were enrolled and randomized to receive study drug into the 24-Week study period.
727331|NCT01977794|The study was conducted at 10 clinical trial sites in Guatemala.|A total of 200 subjects (100 subjects in the amlodipine failed group, and 100 subjects in the bisoprolol failed group) were enrolled and randomized in the trial. Out of which 196 subjects (97 subjects in amlodipine failed group and 99 subjects in bisoprolol failed group) were included in modified intent-to-treat (MITT) analysis set.
727332|NCT01977781||
727333|NCT01977729||
727334|NCT01977690||
727335|NCT01977677|A total of 30 patients were enrolled at one study center.|A total of 32 subjects were screened. One was a screen failure, one withdrew consent prior to initiating the infusion. Twenty-nine subjects enrolled and completed the 28 day Plerixafor infusion. One subject enrolled but did not complete the infusion due to an unrelated adverse event.
727336|NCT01977651|Study enrolled male participants with histologically-confirmed metastatic adenocarcinoma of prostate with ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) or a prior orchiectomy. Participants were evaluated by a neurologist who determined they had at least 1 risk factor for seizure.|Participants who met all inclusion and none of the exclusion criteria were enrolled in the study, completing a 4-month treatment period. Participants who benefited from the treatment were allowed to continue in the extension period. A total 424 participants were enrolled and 423 participants received the study drug.
727337|NCT01977625|18 participants were recruited from the parent study NCT01324024 to complete 3 brain imaging scans.|Of the 18 participants who were recruited, they all were deemed eligible based on the criteria for the parent study NCT01324024. In addition, they must have been deemed eligible to undergo a functional brain imaging scan. Of these 18 participants, 14 completed all 3 scans.
727338|NCT01977612||173 participants were enrolled to the study but 8 participants had a change in their surgical procedure which deemed them ineligible for study enrollment and were excluded from the study before randomization to the arms.
727339|NCT01977573|Two groups of participants(par.) were enrolled in this study. Group 1 consisted of recombinant human erythropoietin(rhEPO)-naive par. whereas Group 2 consisted of rhEPO users.|Post screening, eligible par. were randomized to receive either GSK1278863 once a day (QD) or to the Control arm in a 3:1 fashion in Group 1 and 1:1 fashion in Group 2.
727340|NCT01977482|Eligible participants were hemodialysis-dependent with anemia associated with chronic kidney disease who were switched from a stable dose of recombinant human erythropoietin (rhEPO).|A total of 216 participants with a stable hemoglobin (Hgb) between 9.0-11.5 grams (g)/deciliter (dL) (France sites only: 10.0-11.5 g/dL) were randomized.
727341|NCT01977456||
727342|NCT01977352||
727343|NCT01977222|Consecutive adult patients (≥18years old) with Fontan physiology were recruited through the outpatient cardiology clinic at Boston Children's Hospital between April 2014 and December 2014.|One subject who was enrolled and consented dropped out during the initial assessment due to inability to tolerate the metabolic cart during baseline exercise testing.
727344|NCT01977092|The recruitment of 330 study participants followed a two-step process: first we recruited the house, and then we recruited residents that moved in to those houses. The approximately 50 SLHs participating in the study were located in the Los Angeles area and all were members of the Sober Living Network.|To avoid mixing individuals who received the intervention with individuals who did not within the same house, we randomized at the house level. Once a house was randomized to a study condition, all of the individuals recruited from that house received the same intervention.
727345|NCT01977040|In a retrospective manner, we recruited all pregnancies complicated by vasa previa that delivery between January 1, 2000 and December 31, 2012 at nine Maternal Fetal Medicine Practices. The diagnosis of vasa previa was made either during the antenatal period by an ultrasound or at the time of delivery via clinical and/or pathologic investigation|
727346|NCT01976988||
727347|NCT01976975||
727348|NCT01976871||
727349|NCT01976845|Prior to the day of surgery, potential study patients received a packet of materials (initial patient contact letter, a HIPAA information sheet, and the IRB approved informed consent form) from their surgeon. Patients who were interested in participating in the study were asked to bring the materials to the hospital on the day of surgery.|"Randomization assignment was generated with a 1:1:1 allocation ratio using a computer software program.
~The randomization number specifying the study medication was placed in sealed envelope and given to a non-participating anesthesiologist on the day of the scheduled procedure after completing the patient's preoperative assessment."
727350|NCT01976819||
727351|NCT01976806||
727401|NCT01973439||
727402|NCT01973413||
727352|NCT01976741|Study was conducted at 29 centers in 7 countries, between 30 Dec 2013 (first subject first visit) and 27 Nov 2019 (last subject last visit).|A total of 988 participants were screened, of whom 168 participants were assigned into the study and received at least one dose of study medication.
727353|NCT01976663|126 subjects were enrolled (Enrolled Population); 123 subjects were randomized and treated (Modified Intent-to-Treat). Each subject had one nasolabial fold treated with JUVEDERM VOLIFT® XC and one treated with control. After initial treatment, subjects were eligible for touch-up, asymmetry correction, and repeat treatment per protocol.|
727354|NCT01976650||The Enrolled Population includes all 724 patients consented. The Safety Analysis Population includes 718 patients who were treated per protocol and completed a survey. The Safety Analysis Population was used for all analyses.
727355|NCT01976624||
727356|NCT01976572|Subjects were recruited at Covance from 14th October 2013.|
727357|NCT01976507||
727358|NCT01976442||
727359|NCT01976416||
727360|NCT01976364|Eligible participants (who had previously participated in randomized psoriatic arthritis [PsA] clinical studies with tofacitinib) from qualifying studies A3921091 (NCT01877668) and A3921125 (NCT01882439) were enrolled into this current study A3921092 (NCT01976364).|This main study was a long-term extension study, which also included a sub-study (only for the purpose of efficacy, safety and tolerability of tofacitinib monotherapy as compared to tofacitinib combination therapy with methotrexate). Sub-study included eligible participants from main study who consented to take part in sub-study.
727361|NCT01976338||This study consisted of the following three periods (Screening period: Day -14 to Day -1; treatment period: Day 1 to Month 11; post-treatment Follow-Up period: Month 11 to Month 12). At Baseline (Visit 2, Day 1), eligible patients were randomized in a 2:1 ratio into respective treatment arms
727362|NCT01976312|A total of 253 patients were randomized to this study, 191 patients to the ranibizumab group and 62 patients to the sham group. One patient randomized to the ranibizumab group was excluded from all analyses as informed consent was obtained after first study procedures were performed. Therefore, this patient not included in randomized set.|"This study consisted of the 3 periods (Screening period: Day -14 to Day -1; treatment period:
~Day 1 to Month 11; post-treatment period: Month 11 to Month 12). At Baseline (Visit 2, Day 1), eligible patients were randomized in a 3:1 ratio to one of the treatment arms"
727363|NCT01976299||
727364|NCT01976273||
727365|NCT01976104||A total of 346 participants signed informed consent. Of these 346 participants, 142 were screen failures and 204 were randomized into the study. Of the 142 screen failures, 119 did not meet inclusion/exclusion criteria and 13 withdrew consent, 3 experienced an adverse event, 1 was lost to follow-up and 6 had other not specified reasons.
727366|NCT01975974||
727367|NCT01975948|Seventy seven practices with one hundred and eleven community-based family physicians were recruited between September 2013 and January 2014.|"285 participants were enrolled in the study: Physicians (n=111);Patients (n=129); Medical office Staff (MOAs) (n=45)
~MOA Group: MOAs excluded from outcome analysis due to inconsistent particpation and small sample size"
727368|NCT01975935||
727369|NCT01975922||
727370|NCT01975909||
727371|NCT01975831||
727372|NCT01975701|"All 26 patients included were enrolled in the non-Surgical group, and were treated with BGJ398 125 mg once daily in 28-day cycles, on a 3 weeks on/1 week off schedule (dosing days 1 to 21 of every 28-day cycle).
~No patients were enrolled in the surgical group."|"Patients were planned to be enrolled in two groups:
~Group 1 (non-surgical group) targeted patients with response assessment in neuro-oncology (RANO) defined tumor progression not eligible for surgical resection.
~Group 2 (surgical group) targeted patients with recurrent disease eligible for cytoreductive surgery."
727373|NCT01975675|Participants were enrolled study sites in Japan. The first participant was screened on 15 October 2013. The last study visit occurred on 22 August 2014.|421 participants were screened.
727374|NCT01975519||
727375|NCT01975467||
727376|NCT01975389||The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents.
727377|NCT01975376||
727378|NCT01975285||
727379|NCT01975246||This study is randomised, double-blind, active-control, parallel-group comparison
727380|NCT01975220||
727381|NCT01975090||
727382|NCT01974895|Not all subjects who withdrew from the study were willing to provide a reason for withdrawal. Thus, the reasons for withdrawal for these subjects are unknown.|2 subjects were allocated subject numbers but study vaccine was not administered, thus were excluded from the study prior to group assignment.
727383|NCT01974817||
727384|NCT01974752||
727385|NCT01974700||While 17 were consented, 3 were screen failures, 5 were lost to follow up and one was withdrawn from the study.
727386|NCT01974687|Per protocol, the Group D part of the study allowed to randomize Genotype 2, 3, 4, 5 and 6 Hepatitis C Virus (HCV)-infected participants, however, only Genotype 2 and 3 HCV-infected participants were enrolled.|
727387|NCT01974635||
727388|NCT01974323||
727389|NCT01974284||
727390|NCT01974245|Between September 2012 and May 2014 the patients from Dialysis Unit of the Federal University of São Paulo and Oswaldo Ramos Foundation (São Paulo, Brazil) were screened.|Patients that have in use of any vitamin D compounds, glucocorticoids, immunosuppressors, or with history of liver failure, intestinal malabsorption, malignance, autoimmune disease, active infection, positive HIV, peritonitis in the last month or elevated serum ionized calcium (>1.40 mmol/L) were not included in the study.
727391|NCT01974141||The Intent-to-Treat population is reflected in the overall study properties. This population excludes patients from a site with Good Clinical Practice violations. All data from this site are excluded in the study results.
727392|NCT01974089||
727393|NCT01974050||
727394|NCT01973998||
727395|NCT01973972||
727396|NCT01973777||
727397|NCT01973608|First/Last subject (informed consent): 24 January 2014/17 December 2014. Study completion date:10 June 2015. The study was conducted at 6 sites in the United States.|
727398|NCT01973595||
727403|NCT01973387|A Randomized, Multicenter, Open-Label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor PCI-32765 (Ibrutinib) versus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma|
727404|NCT01973348|49 patients were consented; 45 entered the trial, with 27 assigned to the IO therapy group and 18 to the patching group.|"49 patients were consented; 4 patients were not qualified.
~45 entered the trial, with 27 assigned to the IO therapy group and 18 to the patching group"
727405|NCT01973335|"Dates of the recruitment period: 28/12/2013 till 14/03/2017
~location: emergency services and outpatient cardiology clinic of 2 tertiary care centers (Ziekenhuis Oost-Limburg, Genk, Belgium & UZ Leuven, Leuven, Belgium)"|None, every patient that was enrolled was immediately randomised and started with the protocol of the study.
727406|NCT01973231|The trial was conducted at 56 sites in 9 countries; Czech Republic (5), Finland (4), France (6), Germany (8), Hungary (6), Italy (5), Latvia (6), Lithuania (5) and UK (11).|
727407|NCT01973218|Subjects were recruited from 7 study sites in Korea.|All enrolled subjects were included in the trial.
727408|NCT01973205||
727409|NCT01973062||
727410|NCT01973036|Women presenting to labor & delivery with ruptured membranes with an unfavorable cervix based on sterile digital exam at greater than or equal to 34 weeks were approached by a study team member for participation.|
727411|NCT01972841|"Patients who had symptoms of wet overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled at 435 centers in 42 countries. Eligible participants went into a single-blind, 4-week placebo run-in period and completed a micturition diary the last 7 days prior to each study visit."|A total of 6991 participants were screened, 6275 participants received placebo run-in treatment and 3527 participants were randomized into 1 of 6 treatment arms in a 1:1:1:1:2:2 ratio in the 12-week double-blind treatment period. A total of 953 participants were also enrolled in an ambulatory blood pressure monitoring (ABPM) substudy.
727412|NCT01972789|a total of 349 subjects were randomized to the study (intensive arm, 174; relaxed arm, 175). relaxed 173).|Two randomized subjects, 1 in each treatment group, did not receive study treatment and were excluded from the safety set (347 subjects: intensive arm, 173; relaxed arm, 174). 2 subjects did not have correctly measured BCVA at baseline and were excluded from the FAS (345 subjects: intensive 172;
727413|NCT01972776|In part 1, participants were randomly assigned to one of two treatment arms in a ratio of 3:1 for each cohort. In part 2, participants were stratified by smoking status (current versus ex-smoker) and randomized in a ratio of 2:1 into one of two treatments.|
727414|NCT01972724|Participants took part in the study at 15 investigative sites in Korea from 16 December 2013 to 17 October 2016.|Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled equally in one of 2 treatment groups in the Double-Blind study: pioglitazone15 mg + metformin + sulfonylurea or pioglitazone pioglitazone 30 mg plus metformin + sulfonylurea. Participants received pioglitazone 30 mg + metformin + sulfonylurea in the Open Label study.
727415|NCT01972659||
727416|NCT01972568|The study was conducted at 136 sites in 18 countries in Asia, Europe, North America, Central America, and South America.|
727417|NCT01972529||A total of 370 participants signed informed consent. Of these 370 participants, 139 were screening failures and 231 were randomized into the study. Of the 139 screening failures, 120 did not meet the inclusion/exclusion criteria and the other 19 participants failed due to adverse events, lost to follow-up and withdrawal of consent.
727418|NCT01972516||
727419|NCT01972464|Recruitment began January 2014 and final data collection occurred August 2016. We accepted study referrals and conducted on-site clinic screening assessments in three academic obstetrics clinics associated with Yale New Haven Hospital.|We screened 90 pregnant women who were current smokers intending to quit prior to 32 weeks gestation; 26 were ineligible because they were still smoking at 32 weeks gestation (n=12) or did not meet other eligibility criteria (n=14); 23 were eligible but not randomized because they declined to participate (n=8) or were out of contact (n=15).
727420|NCT01972438|Initially, up to 34 participants were to be enrolled. However, due to the unavailability of the investigational product (IP), recruitment and enrollment was halted at 18 participants in May 2015, and the study closed early. Three participants were enrolled and randomized but unrelated to the early study closure never started IP.|
727421|NCT01972308||
727422|NCT01972282|1025 patients scheduled for a WATCHMAN implant at 47 centers in 13 countries were enrolled over a time period of 19 months prior to the start of the procedure (Oct 2013 - May 2015)|5 patients signed the informed consent but never underwent the implant procedures. Those patients are classified as intents, they are included in epidemiological baseline analyses, but not on the endpoint analysis. 1020 patients underwent the implant procedure and are included in all endpoint analyses, regardless of the success of the implant.
727423|NCT01972217|In this 2-part study, patients with metastatic castrate-resistant prostate cancer (mCRPC) were recruited at 41 sites in Europe, Russia and North America. Part A had 2 cohorts for olaparib dose selection when given with approved treatment abiraterone. Part B compared olaparib versus placebo both with abiraterone in post-chemotherapy mCRPC patients.|Patients dosed in open-label Part A could not participate in Part B which was a randomised, double-blind, placebo-controlled comparison of olaparib + abiraterone versus placebo + abiraterone in patients who had received prior chemotherapy containing docetaxel.
727424|NCT01972204||
727425|NCT01972152|This study involved healthy volunteers who were recruited from the local community surrounding a state-affiliated diabetes treatment center over a period of 3 months.|Of a total of 41 individuals recruited, 4 declined participation, 7 did not meet eligibility criteria and 30 were enrolled.
727426|NCT01972074|Participants were recruited for 3 years (2015 - 2018). They were recruited from existing and new patients at 3 Massachusetts General Hospital sites: Bressler Program for Autism Spectrum Disorder, Lurie Center for Autism, and Child and Adolescent Outpatient Psychiatry Clinic. Participants were also recruited using flyers and internet advertisements.|Per protocol, participants were enrolled when they provided informed consent. They then underwent screening procedures to confirm eligibility. If eligible and willing/able to participate, participants then began study procedures. Some participants dropped out prior to starting study procedures and were, therefore, excluded from this analysis.
727427|NCT01972061||
727428|NCT01971723||
727429|NCT01971645||
727430|NCT01971593||
749808|NCT00669162||
727433|NCT01971554|Sixty-three participants were recruited at 4 clinical sites in the United States.|Male and female participants with Type 2 diabetes mellitus between the ages of 18 and 65 years inclusive were enrolled in this trial.
727434|NCT01971476|In the age group 2 to <12 years, 12 patients were entered and treated. In the age group 12 to <18 years, 10 patients were entered and treated.|In the age group 2 to <12 years, 15 patients were screened, with 3 screen failures. In the age group 12 to <18 years, 14 patients were screened, with 4 screen failures.
727435|NCT01971463||
727436|NCT01971385||
727437|NCT01971346||
727438|NCT01971255||
727439|NCT01971203|Participants were recruited through the Mount Sinai faculty referrals, medical center employee newsletter, and advertisements in local newspapers, radio, and craigslist.|Ninety-four participants were screened - 10 participants did not meet study eligibility, 22 elected not to continue. 62 participants were randomized, but 7 never returned for the first visit, leaving 55 participants who began treatment.
727440|NCT01971086||
727441|NCT01970995|"Study initiated (first subject screened): 01 August 2013
~At admission (Day -2), all the subjects performed a product trial of the THS 2.2 Menthol. During the baseline period, they continued smoking their single preferred brand of mCC. Then, on Day 0, they were randomized to one of the 3 study arms (mTHS 2.2, mCC or SA) in a 2:1:1 ratio."|"Enrolled and randomized population = 160 subjects
~78 subjects in mTHS 2.2
~42 subjects in mCC
~40 subjects in SA
~Number of subjects enrolled but NOT randomized (who tried the mTHS 2.2 at Day -2) = 0"
727442|NCT01970982|"Study initiated (first subject screened): 23 July 2013
~At admission (Day -2), all the subjects performed a product trial of the THS 2.2. During the baseline period, they continued smoking their single preferred brand of CC. Then, on Day 0, subjects were randomized to one of the 3 study arms (THS 2.2, CC or SA) in a 2:1:1 ratio."|"Enrolled and randomized population = 160 subjects
~80 subjects in THS 2.2
~40 subjects in CC
~40 subjects in SA
~Number of subjects enrolled but NOT randomized (who tried the THS 2.2 at Day -2) = 6"
727443|NCT01970943||The study design was indeed crossover, but the cross-over was done immediately on the same day. In other words, participants were either scheduled to receive no intervention, and then placed placebo approximately 2 hours later to allow for washout. Or placed placebo first, and then no intervention approximately 2 hours later. No actual drug used.
727444|NCT01970878|Conducted at 205 sites from November 2013- December 2014. The entire study period was a maximum of 30 weeks.|Study PT003008 was an extension of Studies NCT01854645 and NCT01854658. A proportion of subjects on active treatment were randomly invited to participate. Analysis of Study PT003008 included all subjects enrolled in the lead-in studies to avoid bias. Hence, the number analyzed will be greater than the 892 subjects enrolled into the extension.
727445|NCT01970865||A total of 334 participants were enrolled in this study, and 2 of them (one each in Phase 1 and Phase 2) didn't receive any study treatment.
727446|NCT01970787||
727447|NCT01970592|The pool of candidates were recruited from rehabilitation programs at the Medical University of South Carolina; the Ralph H. Johnson VAMC; and Charleston area communities.|After enrollment, participants were thoroughly evaluated for functional and cognitive impairments as well as physical performance. Descriptive physical performance testing included the lower extremity Fugl-Meyer Assessment (FMA-LE), Stroke Impact Scale (SIS), Berg Balance Scale (BBS) and the NIH Stroke Scale.
727448|NCT01970540|"122 patients were enrolled at 7 sites. 120 patients were treated with DOX/PM01183 combination: 73 Cohort A (DOX [mg/m2]+PM01183 [mg FD]) & 47 Cohort B (DOX [mg/m2]+PM01183 [mg/m2]).
~Patients participated between 25May2011-9Aug2017 (last followup). First dose of the first cycle was given on 13Jun2011 and last dose of the last cycle on 19Jul2017"|"Screening details:
~Age 18-75;CI signed;ECOG PS≤1;histologically/cytologically confirmed diagnosis of advanced disease;Life expectancy≥3 months;not previously treated with anthracycline-containing therapy for advanced disease;No more than two prior lines of cytotoxic-containing chemotherapy regimens;CPK≤2.5xULN;Albumin≥2.5 g/dL"
727449|NCT01970527|As of January 2018, 23 participants consented to the study during accrual duration of 36 months. The participants with metastatic melanoma were recruited from the clinic at Department of Radiation Oncology, University of Washington Medical Center.|The total number of participants that consented to the study are 23, however 1 participant was a screen-fail due to brain metastasis.
727450|NCT01970488|"This study was conducted at 49 centers in 6 countries (Australia, Canada, France, Germany, Hungary, and Poland).
~Participants were randomized in a 1:1 ratio to receive ABP 501 or adalimumab."|Randomization was stratified based on prior biologic use for psoriasis and geographic region. At week 16 participants with a PASI 50 response (≥ 50% improvement in Psoriasis Area and Severity Index score) continued on study; those initially randomized to adalimumab were re-randomized to receive either ABP 501 or adalimumab.
727451|NCT01970475|"This study was conducted at 92 centers in 12 countries in Europe, North America and Latin America.
~The first participant enrolled on 24 October 2013 and the last participant enrolled on 26 May 2014."|Participants were randomized 1:1 to receive either ABP 501 or adalimumab at 40 mg every 2 weeks for 22 weeks. Randomization was stratified by geographic region and prior biologic use for rheumatoid arthritis (capped at 40% of the study population).
727452|NCT01970462||Enrolled differs from reported because the study was discontinued early and the group number was not available from the pharmacy for 3 subjects. We provided the participant flow for the 5 individuals for whom the group assignment was available. Of 8 total patients enrolled, 4 completed the study, 3 of whom had group assignments available
727453|NCT01970397||
727454|NCT01970371||
727455|NCT01970241||
727456|NCT01970176||
727457|NCT01969916||
727458|NCT01969851|The study started to enroll patients in February 2014 and concluded in April 2018.|The Participant Flow refers to the Safety Set which consisted of all enrolled subjects who took at least 1 dose of lacosamide (LCM).
727459|NCT01969799||The trial was designed to have 150 patients, hoping to have at least 140 patients with proven gram negative pneumonia. The trial was terminated at 143 when that goal was achieved.
727460|NCT01969747||
727461|NCT01969721|This was a randomized, double-blind, double-dummy, active-controlled, 4-treatment, 4-period, complete cross-over design.|After signing informed consent, patients entered a 4-week screening period to ensure clinical stability (i.e. no exacerbations).
737372|NCT01322048||One subject was enrolled but was not randomized/assigned to either arm, due to a late withdrawal of care decision.
727462|NCT01969708|The SCORE2 randomized noninferiority clinical trial was conducted at 66 private practice or academic centers in the United States, and included 362 patients with macular edema due to central retinal or hemiretinal vein occlusion who were randomized 1:1 to receive aflibercept or bevacizumab.|Participants were assigned to a treatment arm at enrollment.
727463|NCT01969565|This trial was open to accrual from August 2013 to September 2014.|One patient consented but withdrew prior to beginning treatment.
727464|NCT01969539|The study was closed early based on the results of an interim pharmacokinetic analysis, prior to enrollment of any patient in cohort 2, therefore only the Trudell adapter was assessed (in cohort 1)|
727465|NCT01969500|Individuals with schizophrenia or schizoaffective disorder who were receiving services were recruited through flyers in waiting rooms and bulletin boards at treatment centers, and through referrals from clinical staff. Enrollment was open from November 2015 to July 2016.|N=3 enrolled participants were not assigned because N=1 did not pass a competency screener, N=1 did not meet Recovery Assessment Scale inclusion criteria, and N= 1 was no longer interested prior to completing baseline.
727466|NCT01969448|Enrollment to the study opened to enrollment 03/28/2013 and closed to enrollment on 03/09/2016.|
727467|NCT01969435||
727468|NCT01969240||
727469|NCT01969214||
727470|NCT01969201||
727471|NCT01969162||
727472|NCT01969084||45 subjects were enrolled and 41 were randomized to the study
727473|NCT01969058|First participant was enrolled on July 2, 2014. Accrual to the study closed on May 5, 2016, with 15 U.S and Puerto Rico sites registered and enrolled participants|Participants were randomized 2:1 to Isotretinoin and no study treatment arms. Randomization was stratified by willingness to participate in the gut biopsy substudy, A5330s.
727474|NCT01968980||
727475|NCT01968967||This study was conducted at multiple sites from 28 October 2014 to 15 July 2016 for the Treatment Period and up to 10 July 2017 for the Extension Period.
727476|NCT01968954||
727477|NCT01968811||
727478|NCT01968694||Only 19 of the 20 enrolled started the study because one participant did not participate past consent.
727479|NCT01968551|Participants were enrolled at study sites in the United States and Canada. The first participant was screened on 3 September 2013. The last study visit occurred on 09 July 2016.|231 participants were screened.
727480|NCT01968447||
727481|NCT01968434|Recruiting took place within the Clalit health service community day hospitals. Community day hospitals are places where parents go for usual illnesses and treat most community ailments.|Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21)
727482|NCT01968421|March 1, 2015 was the starting date|
727483|NCT01968382||
727484|NCT01968226||
727485|NCT01968213|564 subjects were recruited from 87 sites across 11 countries and randomized (2:1) to treatment with rucaparib or placebo|
727486|NCT01968135|Women were invited to participate after being seen at one of our institution's clinics with the complaint of bothersome bleeding during use of etonogestrel implant, or after responding to advertisements posted on the internet, in the local newspaper, or around public venues. Women were enrolled and followed from November 2013 - December 2014.|Interested women were screened by phone and subsequently invited for a screening visit. At this visit they were assessed for eligibility based on the specified inclusion/exclusion criteria.
727487|NCT01968070||Part 1 was a single-ascending dose, 2-cohort, 3-period, alternating-group dose-escalation study (cohorts 1-2) and Part 2 of the study was a multiple-ascending dose, 4-cohort, parallel-group, dose-escalation study (cohorts 3-6). Replacement participants received interventions intended for those participants whom discontinued early.
727488|NCT01968057||This was an open-label, 2-period, fixed-sequence study.
727489|NCT01968031||
727490|NCT01967940|Participants were enrolled at study sites in the United States, Uganda, Thailand, Russian Federation, and Dominican Republic. The first participant was screened on 25 October 2013. The last study visit occurred on 31 July 2017.|259 participants were screened.
727491|NCT01967888||
727492|NCT01967862||
727493|NCT01967836||
727494|NCT01967784|Study participants were enrolled from 18 October 2013 to 19 November 2013 at 2 clinical sites in Taiwan.|A total of 100 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.
727495|NCT01967732|"Study initiated (first subject screened): 01 November 2013
~At admission (Day -1), all the subjects performed a product trial (THS 2.2 and subsequently NNS).
~From enrollment, they were asked to remain abstinent from smoking for at least 24 hours (Day 0) before being randomized on Day 1 into 1 of the 4 sequences."|"Enrolled population = 62 subjects = 62 randomized as described below:
~Sequence THS 2.2 then CC: 22 subjects
~Sequence CC then THS 2.2: 22 subjects
~Sequence THS 2.2 then NNS: 9 subjects
~Sequence NNS then THS 2.2: 9 subjects"
727496|NCT01967719|"Study initiated (first subject screened): 02 October 2013
~At admission (Day -1), all the subjects performed a product trial (mTHS 2.2 and subsequently NNS).
~From enrollment, they were asked to remain abstinent from smoking for at least 24 hours (Day 0) before being randomized on Day 1 into 1 of the 4 sequences."|"Enrolled population = 64 subjects: 2 exposed to mTHS 2.2 and NNS at Admission but not randomized and 62 randomized as described below:
~Sequence mTHS 2.2 then mCC: 22 subjects
~Sequence mCC then mTHS 2.2: 22 subjects
~Sequence mTHS 2.2 then NNS: 9 subjects
~Sequence NNS then mTHS 2.2: 9 subjects"
727497|NCT01967706|"Study initiated (first subject screened): 01 August 2013
~At admission (Day -1), all the subjects performed a product trial (Tobacco Sticks and subsequently NRT gum).
~From enrollment, they were asked to remain abstinent from smoking for at least 24 hours (Day 0) before being randomized on Day 1 into 1 of the 4 sequences."|"Enrolled population = 73 subjects: 11 exposed to mTHS and NRT at Admission but not randomized and 62 randomized as described below:
~Sequence mTHS then mCC: 22 subjects
~Sequence mCC then mTHS: 22 subjects
~Sequence mTHS then NRT: 9 subjects
~Sequence NRT then mTHS: 9 subjects"
727498|NCT01967641||
727607|NCT01961115|Patients with advanced melanoma were enrolled at 4 comprehensive cancer centers in the U.S. from Sept.., 2013-Jan., 2017. Patients who failed previous standard therapies for melanoma participated in the study.|
737373|NCT01322022||
748402|NCT00734994|Recruitment Period: 09/2008-09/2010 Location: Urology and Radiation Oncology Clinics|
727499|NCT01967628|Subjects were included if they were 18-60 years old and able to understand and sign a consent form. All study procedures were performed at the University of Iowa Hospitals and Clinics bronchoscopy lab and clinical research unit between May 2008 and July 2010.|Subjects were included if they were 18-60 years.Subjects were excluded if taking a multivitamin or vitamin D supplement within the previous three months, pregnant or breastfeeding,had a vaccination within one month, significant comorbid conditions, respiratory infection, history of positive tuberculin skin test, or use of antibiotics recently.
727500|NCT01967576||
727501|NCT01967550|Start date 04 Oct 2013 end date 05 May 2014|
727502|NCT01967537||
727503|NCT01967433||
727504|NCT01967342||
727505|NCT01967277||
727506|NCT01967225|The study was conducted in 46 study centers in Japan from 23 November 2013 (first subject, first visit) to 28 October 2016 (last subject, last visit).|Overall, 131 participants were screened. Among them, 6 participants failed screening. 125 participants were randomized to one of the 2 treatment groups.
727507|NCT01967173||
727508|NCT01967147|Subjects were recruited from 14 study centers located in France, 4 study centers located in Germany, 3 study centers located in Spain, 3 study centers located in the Netherlands, 4 study centers located in the UK, 4 study centers located in Italy, and 3 study centers located in Poland.|Of the 279 subjects enrolled, 40 were exited as screen failures prior to randomization. An additional 25 were discontinued prior to randomization, following the outcome of the interim analysis. This reporting group includes all randomized subjects (214).
727509|NCT01967134||
727510|NCT01967121||
727511|NCT01967069||
727512|NCT01966978|Total number of subjects consented is 157, total number of subjects randomized is 120, of those 120 only 110 are MITT data set|
727513|NCT01966926|Participants recruited in Sept-Oct 2009 from craigslist.com ads and flyers in a University of Minnesota office building. 58 contacted the study and 28 were excluded [did not complete screening (n=10), not eligible due to weight or health exclusions (n=15), or withdrew before consent (n=3)], resulting in a final sample of 30 participants.|
727514|NCT01966900||
727515|NCT01966809||
727516|NCT01966796|Patients who were admitted to our hospital,Jan 2005 to Dec 2010 The patients with the diagnosis was pneumonia were selected. They were enrolled if they fulfilled the criteria for HCAP defined in 2005 ATS/IDSA|
727517|NCT01966770||
727518|NCT01966731||
727519|NCT01966718||
727520|NCT01966458||Subjects were considered enrolled upon signing informed consent. 19 enrolled subjects weren't randomized as they were considered screen failures. 10 subjects were randomized but didn't receive a device due to death (with 1 subject dying post anesthesia but prior to Left Ventricular Assist Device (LVAD) implant) or screen failure prior to implant.
727521|NCT01966445|This is a Phase 1 study of anti-human epidermal growth factor receptor 3 (HER3) antibody, GSK2849330 in participants with advanced solid tumors expressing HER3. The study was conducted in 2 parts-Part1 (dose escalation) and Part2 (dose expansion). The starting dose in Part1 was 1.4 milligrams per kilogram (mg/kg) GSK2849330 given weekly for 28 days|A total of 29 participants were randomized. The study was conducted in three countries. Participants in the GSK2849330 30 mg/kg weekly arm were not double counted with any other Arm.
727522|NCT01966432|Based on the results of the baseline substance use screen for the parent Southeastern Diabetes Initiative (SEDI) study at the Durham site, participants were categorized into three groups: Minimal-risk Screen (S) Group; At-risk Screen & Brief Intervention (SBI) Group; and, High-risk Screen, Brief Intervention, & Referral to Treatment (SBIRT) Group.|The clinical team consented 134 adults (84% of the eligible patients) for the SBIRT study. Of the 134 adults consented (enrolled), 36 are not accounted for in the results section (do not have baseline data).
727523|NCT01966380||
727524|NCT01966354|The day before IJVC was to be performed, patients (aged 18 or above) in whom IJVC had been indicated were asked to participate in the study. Patients who did not meet any exclusion criteria were included.|
727525|NCT01966159|412 subjects have enrolled and finished at 07Jul2014|
727526|NCT01966120|Trial was conducted in Germany with 7 study sites (Bonn, Dresden, Munich, Wuppertal, Mönchengladbach, Cologne, and Recklinghausen) who recruited patients.|94 patients were screened, 87 patients were randomized (55 patients to BF-200 ALA and 32 patients to placebo) and treated. 7 patients were screening failures: 3 withdrew consent, 2 did not meet the in- /exclusion criteria, and 2 failed for other reasons (recruitment stop).
727527|NCT01966107|This study was conducted at 522 study centers in North America; 35 centers in Canada and 487 centers in the US. A total of 4000 subjects were planned to be enrolled. A total of 3630 subjects were randomized (1:1) to aclidinium bromide 400 μg twice a day (BID) or placebo BID. Rescue medication (albuterol/salbutamol) was provided for all subjects.|Informed consent form was signed; inclusion/exclusion, smoking status, electrocardiogram, pregnancy test, Pulmonary function testing, Chronic obstructive pulmonary disease (COPD) exacerbation were assessed. Out of 3635 subjects, 5 subjects were duplicated, who, in violation of protocol entrance criteria, entered the study more than once.
727528|NCT01966068|Subjects were recruited from 2 practice-based research networks. To ensure low-income children were represented, practices were required to have at least 20% insured by Medicaid or the Children's Health Insurance Program. 9,133 families were invited to enroll.|294 parents/guardians of 294 children consented to participate in the study. Of these, 237 logged onto the MyAsthma portal at least once.
727529|NCT01966042|Refractory angina patients routinely undergoing treatment at the São Paulo Hospital, in São Paulo, Brazil, a referral tertiary Federal University Hospital for coronary heart disease, were included in the study. The study protocol (ReACT™) was approved by the local and national ethical committee and all patients provided written informed consent.|Refractory angina patients were defined as those with functional class IV (angina at rest) according to the Canadian Cardiovascular Society Angina Classification (CCSAC) despite maximum medical therapy, not suitable for conventional myocardial revascularization and with viable myocardium identification.
727608|NCT01961089|40 adult subjects were recruited from among patients seen at the ORASIS eye clinics, including 20 people with cataract in at least one eye and 20 subjects without cataract. The subjects included 5 people with prior refractive surgery, 5 people with high myopia, 5 people with high hyperopia, and 3 persons with dilated pupils.|
727609|NCT01960907||
751384|NCT00589329||
727530|NCT01966003|This study was conducted at 101 sites (14 sites in the US, 11 in Russia, 10 in Australia, 9 in Germany, 8 in Poland, 7 in Hungary, 7 in Romania, 6 in Italy, 6 in Spain, 5 in Bulgaria, 5 in Greece, 3 in the Czech Republic, 3 in Mexico, 3 in Taiwan, 2 in the Netherlands, 1 in Canada, and 1 in Hong Kong).|Eligible participants were randomized in a 1:1 ratio to receive ABP 215 or bevacizumab. Participants were stratified by geographic region (Eastern Europe vs Western Europe vs Asia Pacific/Other vs North America), Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1), and sex.
727531|NCT01965938||
727532|NCT01965899||
727533|NCT01965834||
727534|NCT01965782||18 subjects were screened and enrolled but no drug was given or other data collected due to the study being terminated.
727535|NCT01965756||
727536|NCT01965665||
727537|NCT01965652|This study was conducted at 195 clinical sites in North America (Canada and the United States), Europe (Belgium, Denmark, Estonia, France, Germany, Hungary, Poland, Spain, Sweden, and the United Kingdom), and Africa/Asia Pacific (Australia and South Africa)|"Participants were randomized in a 1:1 ratio to receive naldemedine or placebo for 52 weeks. Randomization was stratified based on documented opioid use (average total daily dose [TDD] during the 14-consecutive-day qualifying period) as follows:
~30 - 100 mg equivalents of oral morphine sulfate.
~> 100 mg equivalents of oral morphine sulfate."
727538|NCT01965600||
727539|NCT01965561||
727540|NCT01965535|Participants were enrolled study sites in France. The first participant was screened on 26 September 2013. The last study visit occurred on 12 November 2014.|172 participants were screened.
727541|NCT01965431||After an initial screening (Visit 1) within Day -23 and Day -3 prior of the first treatment period, subjects meeting all inclusion and none of the exclusion criteria participated in Visits 2 to 5.
727542|NCT01965366||
727543|NCT01965327|12 subjects were screened and all were enrolled in the study between September - December 2013.|
727544|NCT01965288|"Of the 60 subjects enrolled, 60 were fitted with the study lenses and completed the trial (i.e.
~no discontinuations).This study design considered a single-center, (Optometry Research Group), located at the University of Valencia Spain (target 60 subjects)."|All subjects were habitual lens wearers.
727545|NCT01965262|Thirty subjects were dispensed lenses, and nineteen subjects successfully wore both study products.|
727546|NCT01965158|This study was conducted at 68 sites in North America and Europe, including Austria, Czech Republic, Germany, Poland, Spain, United Kingdom, and the United States.|"Participants were randomized in a 1:1 ratio to 0.2 mg of naldemedine or placebo. Participants were stratified based on their documented opioid use (average total daily dose (TDD) during the 14-consecutive-day qualifying period) as follows:
~30 to 100 mg equivalents of oral morphine sulfate
~> 100 mg equivalents of oral morphine sulfate"
727547|NCT01965067||
727548|NCT01965002||
727549|NCT01964976|Participants took part in the study at 207 investigative sites in Japan from 01 July 2011 to 31 December 2014.|Participants with type 2 diabetes mellitus started treatment with alogliptin as per routine clinical practice were observed. As per protocol, participants were enrolled in 1 observational group at the start and were divided into 2 groups based on biguanide use for analysis of safety endpoints. Participant flow data was collected for overall arm.
727550|NCT01964963|Participants took part in the study at 1406 investigative sites in Japan, from 03 August 2011 to 31 July 2017.|Participants with a historical diagnosis of mild type 2 diabetes mellitus were enrolled. Participants received interventions as part of routine medical care.
727551|NCT01964950|Participants took part in the study at 221 investigative sites in Japan from 1-Jul-11 to 31-Dec-14.|Participants with type 2 diabetes mellitus started treatment with alogliptin as per routine clinical practice were observed. As per protocol, participants we enrolled in 1 observational group at the start and were divided into 2 groups based on Sulfonylurea (SU) use for analysis of safety endpoints. Participant data was collected for overall arm.
727552|NCT01964924||Patients on Part 1: trametinib monotherapy until progression and then will continue on to Part 2: trametinib combined with GSK2141795.
727553|NCT01964898||65 patients were recruited. 1 was found to be ineligible pre-randomization.
727554|NCT01964755||
727555|NCT01964716||Total number of participants screened were 526, out of which 500 were enrolled in the study. The study was conducted in Gambia which started on 09 January 2014 and completed on 01 September 2014.
727556|NCT01964547||
727557|NCT01964521||
727558|NCT01964430|The study randomized participants at 160 sites in 21 countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Netherlands, Portugal, Singapore, Republic of Korea, Spain, Taiwan, United Kingdom and the US.|Participants were randomized using a stratified randomization with a 1:1 ratio to either nab-paclitaxel followed by gemcitabine, or gemcitabine alone. Stratification factors were tumor resection status (R0 versus R1), nodal status lymph node positive versus lymph node negative, and region [North America, Europe, and Australia versus Asia Pacific]).
727559|NCT01964378|The trial started on 29 Oct 2013 with the enrollment of the first subject and was completed on 16 Oct 2015 when the last subject completed the last follow-up examination.|200 Participants were enrolled (signed consent): enrollment failures did not meet inclusion or met exclusion criteria (62 participants), died (1), withdrew consent (4), or met other reasons (1). 132 Participants were allocated to treatment and 126 were dosed (Safety Set).
727560|NCT01964352|814 were entered and randomized. One patient randomized to Tiotropium 5 μg was not treated. One patient entered the study with 2 different patient numbers. This patient was counted twice in the randomized set but only once in the treated set. Thus a total of 812 unique patients were treated.|
727561|NCT01964326||Participants were screened by phone, then referred to their participating retail pharmacy site for a scheduled face-to-face interview, after which they were given an empty atorvastatin(Lipitor) over-the-counter(OTC) package to review the information on the outside of the entire package,after which decision was made to purchase the medicine by them.
727610|NCT01960855||The study included a screening period of 30 days.
727611|NCT01960842||A total of 31 participants were enrolled and had undergone the N-J placement procedure and were included in the Safety Analysis Set; 1 participant did not have at least 1 post-PEG efficacy assessment and was excluded from the Full Analysis Set (FAS), which consisted of 30 participants.
727562|NCT01964300|Patients 18 months to 25 years with histologically confirmed craniopharyngioma were enrolled at Pediatric Brain Tumor Consortium (PBTC) member institutions. The first patient was enrolled on 4/1/2014 and the last patient was enrolled on 11/20/2017. Accrual was halted early due to lack of efficacy in stratum 2 and slow accrual in stratum 1.|Stratum 1 patients had progressive unresectable or recurrent craniopharyngiomas treated with surgery alone. Stratum 2 patients had progressive/recurrent craniopharyngiomas following radiation. 19 patients were enrolled (7 stratum 1, 12 stratum 2); one of the stratum 2 patients was ineligible leaving 18 eligible patients (7 stratum 1, 11 stratum 2).
727563|NCT01964222||
727564|NCT01964105||
727565|NCT01964092||
727566|NCT01963923||During the study period, 40 patients were recruited (20 per arm) but only 12 patients in the control group and 10 patients in the rehabilitation group were included in the analysis due to losses in follow-up
727567|NCT01963845|Jan. 1, 2014 to May 1, 2015|
727568|NCT01963767||From the 139 participants who were consented in the study, only 113 participated in the baseline assessment. Of the 26 who did not participate in the baseline assessment, 14 failed the screening and 12 dropped out before the baseline assessment.
727569|NCT01963676|Patients recruited through medical providers. Providers knew inclusion/exclusion criteria and discussed the study with patients during their regular appointments. Interested participants contacted the study team. Participants recruited from the STEP clinic (Chapel Hill and Raleigh), and the Burlington ACT team. Recruitment between 4/14 and 9/14.|Subjects randomly assigned to one of two groups, transcranial direct stimulation (tDCS) group or active sham group. tDCS group, direct current was delivered during awake, resting state for 20minutes on 5 consecutive days. Sham stimulation was delivered for an equal period of time and number of sessions. 27 subjects signed consent, 1 withdrew.
727570|NCT01963611||
727571|NCT01963481||
727572|NCT01963403||
727573|NCT01963260|Amendment 3 specified a re-enrollment procedure for eligible participants in Part 2 to participate in more than one dosing panel.|2 participants that completed Part 2 10 mg/kg were re-enrolled in Part 2 100 mg/kg & dosed. Both participants completed Part 2 100 mg/kg. 1 participant originally assigned to Part 2 30 mg/kg received placebo in error & is included in Part 2 Placebo.
727574|NCT01963234||
727575|NCT01963169||
727576|NCT01963143||
727577|NCT01963117||
727578|NCT01963091||
727579|NCT01963078|Participants were recruited primarily through media advertisements and flyers.|
727580|NCT01962987||
727581|NCT01962974||The study was terminated early due to low recruitment; only 7 participants were enrolled.
727582|NCT01962961||
727583|NCT01962922|25 November 2013 (first patient enrolled) to 09-Mar-2015 (last patient completed initial pharmacokinetics [PK] portion of the study, the 'PK Cross-over' period), approximately 16 months enrolled from 3 US medical centers:University of Pennsylvania;University of Illinois at Chicago;Washington School of Medicine|
727584|NCT01962896||
727585|NCT01962870|This study was conducted in the Autism and Developmental Disorders Clinic in the Division of Child and Adolescent Psychiatry at Stanford University. Recruitment began in December 2013 and ended in May 2017.|68 participants signed the consent form and enrolled in the study. Of those 68 participants, 27 participants did not meet the eligibility criteria for the study and 11 participants declined to participate prior to randomization. 30 participants were randomized.
727586|NCT01962714||
727587|NCT01962688|Heart Failure patients presented at outpatient clinics were prospectively recruited.|
727588|NCT01962675||One participant withdrew before assignment
727589|NCT01962558|Sixty-two subjects were screened for inclusion into the study. Nine (9) did not meet inclusion criteria, 15 declined to participate, 3 had medical issues, and 5 were screened but were after the study limit of 30. Thirty subjects were enrolled and implanted with the study device.|
727590|NCT01962493|The study was conducted at two sites in the UK. Participants were recruited from the site's database and by use of advertisements.|In total 314 participants were screened and 160 participants were randomised of whom 150 completed the study. Of the 10 participants that did not completed the study, 3 had adverse events; 1 had protocol violation and 6 had withdrawal of consent.
727591|NCT01962441|Participants were enrolled at study sites in Europe, North America, Australia, and New Zealand. The first participant was screened on 24 September 2013. The last study visit occurred on 07 July 2016.|776 participants were screened.
727592|NCT01962428|A total of 278 patients were recruited at 8 centers in Beijing and allocated into two groups using block randomization: a high LD group (360 mg) and a conventional LD group (180 mg).|Patients excluded(n=564)
727593|NCT01962298|Patients were screened for inclusion and approached the night prior to their elective surgery|
727594|NCT01962207||In this study, participants from the study MENACWY-TT-027 [NCT00427908] were followed up for assessment of persistence of immune response and safety. And those who consented received booster vaccination and were followed up for another 6 months.
727595|NCT01962103||Sixty-five participants were included in the Phase 1 enrolled population, and 64 enrolled partcipants received at least 1 dose of study drug and were included in the safety population, noted below. Forty-two participants were included in the Phase 2 enrolled and safety populations.
727596|NCT01962025||
727597|NCT01961921|A total of 27 subjects were enrolled.|
727598|NCT01961609|This study consisted of 3 periods: initiation, maintenance 1 and maintenance 2. During the initiation period, participants received secukinumab 150 mg or 300 mg for 16 weeks.|For both maintenance periods 1 and 2, after 16 weeks and 48 weeks, respectively, responders at both the 150 mg and 300 mg doses continued on their initiation doses during maintenance periods 1 and 2. Non-responders at 150 mg were uptitrated to 300 mg. Non-responders at 300 mg returned to routine treatment under the care of their usual clinician.
727599|NCT01961544||
727600|NCT01961531||
727601|NCT01961362|We enrolled patients with PF not using supplemental O2 and then followed them forward until they were prescribed supplemental O2 by their treating practitioner, and then we followed them for an additional 12 months after being prescribed O2.|We enrolled 19 subjects.
727602|NCT01961349|Of the 279 consented subjects, 7 were excluded after screening.|
727612|NCT01960816||
727613|NCT01960790||A total of 473 participants were enrolled in the study; 462 participants were analyzed for safety and 383 participants were analyzed for efficacy.
727614|NCT01960725||
727615|NCT01960530||
727616|NCT01960465|"January 2015 to August 2019, recruitment by chart review (results of home sleep apnea test) at Jesse Brown VA.
~Participants were contacted by phone, consented on screening/Visit 1."|All participants had moderate to severe newly diagnosed/untreated OSA> They were started on PAP therapy after visit 1.
727617|NCT01960413||
727618|NCT01960400||
727619|NCT01960387||
727620|NCT01960348|A total of 225 patients with hereditary transthyretin (hATTR) amyloidosis were enrolled and randomized in the study.|
727621|NCT01960296|Participants from 6 institution-affiliated ambulatory general surgery clinics were assessed for eligibility between January 2011 and May 2013.|
727622|NCT01960140||This was an open-label, fixed-sequence, 2-period study of healthy participants.
727623|NCT01960114||
727624|NCT01960075|ESETT had a total of 478 enrollments. This number includes 16 re-enrollers. This was an EFIC trial so all consents happened after treatment. All enrollments went through the same process of consent even if they were reenrolled. The first 400 patients were used in several parts of analyses since the trial stopped early for futility (prespecified).|
727625|NCT01959945||The randomized population (219 subjects) includes all subjects who were randomized and the safety population (217 subjects) includes all randomized subjects who received any dose of study vaccine and provided any safety. Two (2) randomized subjects did not fit the criteria to be included in the safety population and were excluded from the analysis.
727626|NCT01959932|"Study initiated (first subject screened): 29 June 2013
~At admission (Day -2), all the subjects performed a product trial of the THS 2.2. During the baseline period, they continued smoking their single preferred brand of CC. Then, on Day 0, subjects were randomized to one of the 3 study arms (THS 2.2, CC or SA) in a 2:1:1 ratio."|"Enrolled and randomized population = 160 subjects
~80 subjects in THS 2.2
~41 subjects in CC
~39 subjects in SA
~Number of subjects enrolled but NOT randomized (who tried the THS 2.2 at Day -2) = 9"
727627|NCT01959919||
727628|NCT01959880||
727629|NCT01959841|The study was conducted at 106 sites in Japan from September 2013 to Jully 2015|
727630|NCT01959685||
727631|NCT01959672||
727632|NCT01959607|"Study initiated (first subject screened): 31 July 2013
~At admission (Day -1), all the subjects performed a product trial (Tobacco Sticks and subsequently NRT gum).
~From enrollment, they were asked to remain abstinent from smoking for at least 24 hours (Day 0) before being randomized on Day 1 into 1 of the 4 sequences."|"Enrolled population = 65 subjects: 3 subjects exposed to THS 2.2 and NRT gum at Admission but not randomized and 62 randomized as described below:
~Sequence THS 2.2 then CC: 22 subjects
~Sequence CC then THS 2.2: 22 subjects
~Sequence THS 2.2 then NRT: 9 subjects
~Sequence NRT then THS 2.2: 9 subjects"
727633|NCT01959581||
727634|NCT01959542||
727635|NCT01959529|The trial was conducted at 438 sites in 20 countries as follows: Algeria: 6; Argentina: 4; Brazil: 10; Canada: 6; Croatia: 5; Greece: 6; India: 26; Italy: 10; Japan: 8; Republic of Korea: 4; Malaysia: 8; Mexico: 7; Poland: 8; Romania: 4; Russian Federation: 20; South Africa: 15; Spain: 6; Thailand: 6; United Kingdom: 8; United States: 271.|
727636|NCT01959516|A total of 126 patients were randomized to one of the two treatment sequences in a ratio of 1:1. Due to misrandomization, two patients did not receive at least one dose of the study treatment. Both, safety and ITT population included 124 patients.|
727637|NCT01959503||
727638|NCT01959490||
727639|NCT01959425|The first subject was enrolled April 17, 2013. The last subject was enrolled January 25, 2019.|This was a prospective, multicenter, randomized, controlled, two arm, 1:1 design. Enrolled subjects N=80 (subjects signed informed consent). 63 subjects underwent study procedures, 17 subjects were excluded prior to randomization. According to protocol, enrolled subjects = subjects who sign the study's informed consent form.
727640|NCT01959412||
727641|NCT01959347||
727642|NCT01959334||
727643|NCT01959243||Participants were randomized in a 2:1 ratio to receive brimonidine tartrate ophthalmic solution or the vehicle of brimonidine tartrate ophthalmic solution, respectively.
727644|NCT01959230||Participants were randomized in a 2:1 ratio to receive brimonidine tartrate ophthalmic solution or the vehicle of brimonidine tartrate ophthalmic solution, respectively.
727645|NCT01959178|There were 146 participants (292 eyes) were enrolled in this study. One-half of the participants were randomized to receive the investigational lens, and the other half to the control lens. After one week, the participant crossed over to the second lens type for one week.|
727646|NCT01959165|In the protocol part, the number of enrolled participants was 44. This number means 44 participants who were assigned and received the treatment. In fact, 59 participants signed informed consent form. Out of the enrolled, 45 participants were assigned, and 1 out of the 45 participants discontinued the study without receiving any treatment.|Out of the 59 enrolled participants, 14 participapatients were not assigned to any arm. Out of these 14 participants, 13 participants did not meet the eligibility criteria and 1 participants withdrew the informed consent.
727647|NCT01959139||126 participants were enrolled to this study, however, 1 withdrew consent and 3 were ineligible.
727648|NCT01959113|Adults with AD were recruited from the University of California, San Diego (UCSD), La Jolla, CA, and the National Jewish Health (NJH), Denver, CO.|All subjects avoided any treatments and therapies that may potentially affect skin microbiome before sample collection.
727649|NCT01959048||
727650|NCT01959035||
727651|NCT01958918|Patients were recruited from 6 sites in Austria, 2 sites in Belgium, 2 sites in Denmark and 5 sites from France.|"This reporting group included all patients randomized to one of the treatment arms (Randomized Set)
~The Full Analysis Set (FAS) consisted of all patients who received at least one application of study treatment and had at least one post-baseline assessment for SD-OCT."
727652|NCT01958827||This study included a 21-day screening period.
727759|NCT01952054|Recruitment Period: May 8, 2015 to Apr 4, 2017. All recruitment performed at The University of Texas MD Anderson Cancer Center.|One participant was ineligible due to screen failure
751433|NCT00587054||
752411|NCT00538642||
727653|NCT01958788|The study was approved by Human Research Ethics Committees of Concordia University and the Hôpital du Sacré-Coeur de Montréal. Participants self-referred to the Hôpital du Sacré-Coeur de Montréal anxiety clinic via advertisements placed in a local newspaper. Recruitment occurred between April 2013 to March 2014.|
727654|NCT01958671||
727655|NCT01958645|Male healthy volunteers recruited by advertisement during the period October 2013 - October 2014|"The study was prematurely terminated after 2 cohorts as dose escalation stopping criteria (PD thresholds) were reached and it was judged to be of limited value to expose more healthy subjects.
~Cohort 1: 2 placebo + 4 MEDI8111 dose 1. Cohort 2: 2 placebo + 4 MEDI8111 dose 2."
727656|NCT01958619||
727657|NCT01958606||
727658|NCT01958489||All participants were administered 40 milligrams (mg) Pravastatin on Day 1 (Period 1) and 130 mg Evacetrapib on Days 2 through 11 and 40 mg Pravastatin coadministered on Day 11 (Period 2).
727659|NCT01958476|Recruitment took place at Tufts Medical Center, Baystate Children's Hospital, Boston Medical Center, Maine Medical Center, Shands Jacksonville Medical Center, University of Pittsburgh Medical Center, Vanderbilt University Medical Center, and Women & Infants Hospital of Rhode Island.|If infant was diagnosed with NAS (Finnegan score ≥8 on two consecutive occasions, or ≥12 on single assessment) and research pharmacy staff were unavailable for preparation of trial drug, infant could receive one dose of morphine prior to randomization. Dosing was based on weight and Finnegan scores.
727660|NCT01958437||
727661|NCT01958346||
727662|NCT01958320||
727663|NCT01958294||
727664|NCT01958281|Participants were enrolled at study sites in the United States and New Zealand. The first participant was screened on 07 October 2013. The last study visit occurred on 19 October 2017.|32 participants were screened for Cohorts 1 and 2 and 33 participants were screened for Cohort 3.
727665|NCT01958164||
727666|NCT01958125||
727667|NCT01958112||
727668|NCT01958073||At the start of the study we began with the intent of 3 groups for analysis, separating the two forms of vaginal estrogen into separate groups and comparing them to a placebo group. Due to difficulties with recruitment, our protocol was amended so that the two vaginal estrogen groups were combined to one vaginal estrogen group compared to placebo.
727669|NCT01958060|This trial was initiated at two centres. As one of the trial centres did not enrol any subjects by the time of premature termination of the trial; the trial was conducted only at one centre.|Partially randomised, placebo-controlled within dose groups, single-blind, single rising dose, multiple centres (dose escalation intravenous [iv] bridging to subcutaneous [sc] in parallel). 35 subjects were enrolled and 32 subjects were treated.
727670|NCT01958021||Six-hundred and sixty-eight patients were randomized; 334 patients each to the ribociclib plus letrozole arm and the placebo plus letrozole arm. Four patients who were randomized to the placebo plus letrozole arm did not receive study treatment; three due to physician's decision and one due to subject/guardian decision.
727671|NCT01958008|The trial consisted of 3 sequential dose groups of 28 patients each. Within each dose group, 21 patients received BI 113608 and 7 received placebo|
727672|NCT01957930||
727673|NCT01957865||
727674|NCT01957787||
727675|NCT01957761||
727676|NCT01957709|Recruitment was done in the Seattle Cancer Care Alliance medical clinic, or by patient referral.|
727677|NCT01957657|The patient groups with renal impairment were to be investigated consecutively starting with the mildly impaired, followed by the moderately impaired, and the severely impaired group. Normal renal function patients were to be investigated last. The trial was terminated after four patients were enrolled and completed.|
727678|NCT01957644|The trial had 2 parts.|Part 1:Starting dose of volasertib 250 mg administered on Day1 and Day15.The dose was escalated in 50 mg steps up to 300 mg.Flat dosing in Part 1. Part 2:volasertib dosing on Day1 in schedule A, on Day7 in schedule B, on Day1+ Day7 in schedule C.Body surface area (BSA) adapted dosing in Part 2. In each cycle, azacitidine was given from Day1 to 7
727679|NCT01957579|First patient enrolled on 25 May 2011. Last patient last visit on 15 September 2015.|A total of 32 patients were enrolled into the study. Twelve patients were screen failures, thus 20 patients received MEDI-551.
727680|NCT01957553|The subjects were recruited from Coloplast user data base, from hospital sites and stoma care sites.|130 subjects were randomised, however 3 of these were not exposed to a product and where not included in the safety population. The participant flow below is generated based on the safety population.
727681|NCT01957488|The subjects were recruited through the Coloplast database and hospital sites.|
727682|NCT01957475|The subjects were recruited through the danish Coloplast database.|
727683|NCT01957462||
727684|NCT01957410|A total of 13 participants were enrolled, treated and completed the study.|
727685|NCT01957397|Subjects are recruited from the Coloplast A/S user database in Denmark.|"The subjects are randomised to two arms
~In both arms the subjects start measuring the performance of own product to collect baseline data.
~In this arm the subjects are randomised between Coloplast Test1 and Coloplast Test 2
~In the third test period all subject test Coloplast Test 3"
727686|NCT01957384|The subjects were recruited through the Coloplast database in Denmark|"25 subjects signed informed consent and were randomized. 2 subjects were screening failures and did not test any products. One subject violated an inclusion criterion (convex user). The subject tested both test products and is therefore included in the safety population.
~The 3 subjects are not included in the participant flow below."
727687|NCT01957215|The study was conducted across multiple sites in China.|
727688|NCT01957202||Participants who met the eligibility criteria at Screening were randomized to 1 of 18 treatment sequences. The treatment phase was comprised of three 8-day treatment periods, each separated by a 14- to 28-day washout period.
727689|NCT01957163|Participants ≥ 40 years of age with history of chronic obstructive pulmonary disease (COPD) and a smoking history of ≥ 10 pack-years were enrolled in the study. Participants completed a 4-week run-in period, in which they received fluticasone furoate 100 micrograms(µg)/vilanterol 25 µg, followed by a 12-week treatment period and 1-week follow-up.|A total of 619 participants (pars.), representing the enrolled particpants, were randomized to study treatment and comprised the Intent-to-Treat (ITT) Population (participants randomized to treatment who received ≥ 1 dose of randomized study medication in the treatment period).
727690|NCT01957150|The study was conducted on participants with chronic obstructive pulmonary disease (COPD) in five countries to assess the long-term safety effects of Fluticasone Furoate (FF) component of the FF/Vilanterol (VI) inhalation powder.|A total of 482 participants were screened of which 199 were screen failures. A total of 283 participants were randomized in a 1:1 ratio to receive either VI or FF/VI.
727691|NCT01957137|Thirty subjects were enrolled into the study from Sept 10, 2013 through May 22, 2015 from 3 US centers.|
727692|NCT01957111|Participants were recruited from the general community and consisted of a group of with chronic insomnia disorder and age- and sex-matched good sleepers.|
727693|NCT01957085||
727694|NCT01956773||
727695|NCT01956669|This study was conducted at 30 centers in 7 countries: Canada (2), Czech Republic (1), France (1), Hungary (1), Slovakia (1), Spain (1) and USA (23).|154 patients were planned to be enrolled in the study. A total of 57 patients were randomized and analyzed: cohort 1 (12), cohort 2 (11), cohort 3 (10), cohort 4 (10), cohort 5 (4), cohort 6 (4) and cohort 7 (6).
727696|NCT01956435||
727697|NCT01956279||170 participants enrolled; 142 participants were randomized after a 2-week placebo lead-in phase. The remaining 28 randomized participants were withdrawn prior to week 4 post-randomization for various reasons - including medication changes during the study (exclusionary) and participants unavailable for continued contact.
727698|NCT01956240|Fliers posted in the local university setting and community were used to recruit symptomatic individuals, between february of 2012 and January of 2014. Asymptomatic individuals were recruited through personal contacts of the investigators.|If participants did not come back to second evaluation, they were not assignments to groups.
727699|NCT01956123|A total of 32 investigational sites included subjects to the trial : 3 in Belgium, 3 in Brazil, 3 in Canada, 3 in the Czech Republic, 2 in Denmark, 2 in Italy, 2 in Poland, 2 in Russia, 10 in Spain and 2 in United Kingdom.|Subjects who participated in Trial 000004 (NCT01956110) (controlled ovarian stimulation [COS] cycle 1) & failed to achieve ongoing pregnancy were eligible for the trial. For COS cycle 2, 520 subjects were screened and 513 enrolled. For COS cycle 3, 190 subjects were screened and 189 enrolled. Subjects were exposed to the same IMP as in COS cycle 1.
727700|NCT01956110|A total of 37 sites randomised subjects into the trial : 3 in Belgium, 3 in Brazil, 3 in Canada, 4 in the Czech Republic, 2 in Denmark, 2 in France, 2 in Italy, 2 in Poland, 4 in Russia, 10 in Spain and 2 in United Kingdom.|A total of 1501 subjects were screened in the trial, of whom 1329 subjects were randomised: 666 subjects to FE 999049 and 663 subjects to GONAL-F. Three subjects were randomisation failures and did not receive investigational medicinal product (IMP); 1 in the FE 999049 group and 2 in the GONAL-F group.
727701|NCT01956097||
727702|NCT01956071|Full time employees of Pennington Biomedical Research Center will be invited by email to participate in an on-line screening survey. The on-line survey will include a series of questions to determine eligibility.|
727703|NCT01956032||
727704|NCT01955954||
727705|NCT01955837|Participants were enrolled at 406 centers in China, the Republic of Korea and Thailand from 16 October 2013 to 15 June 2015.|
727706|NCT01955733||97 subjects were screened for eligibility to participate in this extension trial. 91 subjects met all inclusion and exclusion criteria and were assigned to receive treatment.
727707|NCT01955720||
727708|NCT01955707||
727709|NCT01955629|The study was conducted at 2 sites in Italy. A total of 6 participants were screened between 17 Dec 2013 and 24 Feb 2014, out of which 4 participants were enrolled and treated.|Participants enrolled in Part-1 of study to assess recommended phase 2 dose (RP2D) of combination of aflibercept with oxaliplatin and capecitabine. 3 participants discontinued due to adverse events (AE) and 1 participant due to disease progression (DP) at dose level 1 of treatment. Part-2 of study (efficacy and safety evaluation) was not performed.
727710|NCT01955564|A total of 54 healthy males, who were between the age of 18-45 years old, with a minimum body weight of 45 kg and body mass index of more than or equal to 30, were recruited and observed in the period from 23rd of July 2013 till 19th of September 2014 in this study conducted at a single site in the US.|
727711|NCT01955473|First/Last subject (informed consent): 30 October 2013/10 Jun 2015. Study completion date: 30 October 2015. Clinical data cut-off: 30 October 2015. The study was conducted by 6 Investigators in 6 sites in Japan.|A total of 60 subjects were screened for eligibility, out of which and 51 subjects were randomized into the study.
727712|NCT01955434||
727713|NCT01955382||
727714|NCT01955369||
727715|NCT01955161||
727716|NCT01955122||
727717|NCT01955083|This study was a prospective, randomized, parallel-controlled trial in a tertiary medical center (Department of Otorhinolaryngology, Head and Neck Surgery, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan). Subjects were recruitment from October 1, 2010 to March 31, 2012.|The additional inclusion criteria were: a) length of the soft palate ≥ 2.5 cm and b) the width of the base of the uvular ≥ 1.0 cm. The exclusion criteria were: a) tonsillar hypertrophy; b) high tongue position; c) retrognathia; d) craniofacial abnormalities, e) trismus, f) allergy to anesthetic, and g) poorly controlled medical disorders.
727718|NCT01955044||
727719|NCT01955005||
727720|NCT01954927|Participants meeting eligibility criteria were enrolled between 10/7/2013 to 1/3/2018. They were randomized to either gabapentin or placebo.|The study was stopped early due to slow accrual when there were 82 patients with evaluable pain assessments available for the primary objective. Patients asleep at pain assessment times led to missing pain assessments.
727721|NCT01954771||
727722|NCT01954745||
727723|NCT01954628|The study was conducted in 8 countries: Australia, Denmark, Finland, Hungary, New Zealand, Poland, Sweden and US. US subjects participating in 6 month safety follow-up continued in the study until November 2015.|Four hundred subjects were randomized into two subsets: (1) Subjects suitable for outpatient treatment of a current exacerbation of COPD (within 3 days of diagnosis) & (2) Subjects who had been hospitalized in order to treat their exacerbation for not more than 7 days & were ready to be discharged or had been discharged within the last 3 days.
727800|NCT01949389|100 Individuals were recruited between October 2013 and May 2014.|A single subject completed informed consent procedures and signed the informed consent document, but then was found not to meet exclusion criteria on review of the medical record. The individual was disenrolled.
727801|NCT01949337||
727724|NCT01954394|The study was conducted at 177 centers in 24 countries. Overall, 986 participants who completed study EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831) were enrolled between December 2013 and December 2014.|The Day 1 visit of this study was: the end of treatment visit of the 78-week treatment period for participants who completed EFC12492, R727-CL-1112 and EFC12732; and the end of study visit i.e. 8 weeks after completion of the 78-week treatment period for participants who completed LTS11717.
727725|NCT01954342||
727726|NCT01954264||
727727|NCT01954251||Out of the 829 subjects enrolled in this trial, 1 subject did not receive vaccination even though subject number had been allocated, hence he/she was excluded from study start.
727728|NCT01954160||5 participants were enrolled. 4 subjects received treatment, 1 subject did not receive treatment due to ineligibility secondary to renal doppler findings.
727729|NCT01954121|This study started to enroll subjects in China in September 2013.|Participant Flow refers to the Randomized Set which consists of all subjects who were randomized in this study.
727730|NCT01954082|From April 2014 to September 2015, infants born before 28 weeks gestation and surviving >12 hours were screened when admitted to one of the 18 NICHD NRN Centers (approximately 44 sites) in the United States and enrolled in the study if they met the eligibility criteria and consent was obtained before 72 hours postnatal age.|
727731|NCT01954056|Infants < 48 hours of age and born at ≥ 34 weeks gestational age were screened for the study between June 2014 and July 2015 at the 16 NRN Clinical Centers. Those who were intubated and on mechanical ventilation for at least 2 hours within the first 72 hours were considered for the study.|
727732|NCT01954017||
727733|NCT01953913|Participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation(s), who have never been treated with an EGFR-tyrosine kinase inhibitor (TKI) were recruited in the phase IIIb open label, multicentre, single-arm trial.|All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that they (all participants) met all inclusion/exclusion criteria. Participants were not to be entered to trial treatment if any one of the specific entry criteria were not met.
727734|NCT01953874||
727735|NCT01953783|Participants took part in the study at 1 investigative site in the United States from 19 March 2014 to 09 February 2016.|Participants with a historical diagnosis of advanced solid tumors or lymphoma were enrolled in 1 treatment group of this 2-part study to receive ixazomib.
727736|NCT01953601|N=1454 participants with prodromal Alzheimer's Disease (AD) were randomized, with N=1451 receiving study treatment.|This trial was conducted in 2 parts: a Base Study (Part 1), followed by an Extension Study (Part 2). Participants completing Part 1 had the option to continue to Part 2.
727737|NCT01953575||
727738|NCT01953432||
727739|NCT01953354|Of all the participating sites, nine reached the study intervention randomization phase for >=one participant.The first site was activated in November 2013 and the last participant was randomized in March 2015.|
727740|NCT01953328|Japanese men and women ≥ 20 to ≤ 85 years of age, with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (2.6 mmol/L), fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L), and at high risk for cardiovascular events were eligible to participate. First patient enrolled on 07 October 2013 and last patient enrolled on 17 February 2014.|409 participants were randomized to 1 of 2 open-label atorvastatin cohorts (5 mg or 20 mg) for the lipid stabilization period; 404 were then randomized to blinded investigational product. Both randomizations were stratified by heterozygous familial hypercholesterolemia (HeFH) diagnosis and lipid-lowering therapy.
727741|NCT01953237||
727742|NCT01953224||Pre-pilot results (N = 10) are not reported here, as outcomes are not comparable to those from the main trial. Specifically, the pre-pilot tested assignment of mobile phones to individuals as a delivery method for the intervention, which was found to be not feasible. Conclusions from the pre-pilot about intervention content would be biased.
727743|NCT01953211|clinic|voluntary
727744|NCT01953081||
727745|NCT01953003||
727746|NCT01952834||
727747|NCT01952691||
727748|NCT01952678|In the present study GE-001-011 (NCT01952678), participants who previously administered DaTscan™ and had undergone single photon emission computed tomography (SPECT) imaging of the brain per local practice at each institution, were enrolled.|A total of 102 non-Caucasian and 102 Caucasian participants were enrolled in the study.
727749|NCT01952665|This was a 1 month, cross-over dispensing study conducted at 6 clinical sites in the US. 63 subjects were enrolled, 12 were discontinued and 51 completed the study.|
727750|NCT01952600||
727751|NCT01952574|"This study was conducted at 59 centers in North America (Canada, USA) and Europe (Denmark, Finland, Germany, Norway, Sweden, and Portugal).
~The study consisted of a 12-week double-blind treatment phase (DBTP) and a 256-week open-label treatment phase (OLTP) followed by a safety follow-up of 8 to 12 weeks (12 -16 weeks after last dose). The OLTP portion of the study was not conducted in Norway."|"Participants were randomized 3:2:2:2 to receive placebo, erenumab 7 mg, erenumab 21 mg, or erenumab 70 mg once a month (QM) in the double-blind phase. Randomization was stratified by region (North America vs. Europe).
~During the open-label treatment phase, participants in the United States (US) could participate in an optional Clinical Home Use (CHU) substudy."
727752|NCT01952470||
727753|NCT01952444||
727754|NCT01952418||
727755|NCT01952366||
727756|NCT01952301|Our study sample was derived from the population of patients who presented at our practice between 11-3-2010 and 3-16-2011 and met predetermined selection criteria|
727757|NCT01952145|The trial was conducted at 75 sites in 10 countries as follows: Argentina: 5 sites; Australia: 4 sites; Greece: 6 sites, Hungary: 4 sites; Mexico: 5 sites, Russian Federation: 11 sites; Slovakia: 11 sites, South Africa: 4 sites; Spain: 6 sites, United States: 19 sites.|Subjects who were recruited had T2DM and were required to have been on treatment with stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening in combination with a stable daily dose of metformin (≥1500 mg or max tolerated dose) for at least 90 days prior to screening.
727758|NCT01952080||
727877|NCT01944293||
727878|NCT01944098||
752096|NCT00554294|second and third graders of participating schools|
727760|NCT01952041|Eligible individuals at a medical clinic were identified through electronic medical records and approached by a staff member to be recruited for the study. Recruitment was open from March 2015 until July 2016.|"N=23 participants withdrew before randomization:
~N=1 did not complete baseline, N=15 no longer receiving services at the study site, N=1 incarcerated, N=6 no longer interested in participating."
727761|NCT01952015||A total of 15 patients were screened, and 12 patients entered the induction period. The reason for all screen failures was patient/guardian decisions
727762|NCT01951963||77 met eligibility criteria and 63 were randomized to one of the two study groups.
727763|NCT01951950||
727764|NCT01951820||
727765|NCT01951768||
727766|NCT01951703||A total of 136 subjects were enrolled in the study; 9 subjects did not meet the inclusion and exclusion criteria and not randomized. Of the 127 randomized subjects, 6 were prematurely discontinued from the study and 2 were excluded from the analysis due to major protocol deviations.
727767|NCT01951651||
727768|NCT01951586|This study was conducted at 57 centers in 10 countries including the United Kingdom, Netherlands, France, Italy, Germany, Czech Republic, United States, Canada, Australia and Greece. Participants were enrolled from 31 December 2013 to 21 May 2015.|Participants were randomized in a 2:1 ratio to receive denosumab or placebo. Randomization was stratified based on the presence of bone metastasis (yes or no), histology (squamous versus non-squamous), and geographic region (North America, Western Europe/Australia, and rest of world [ROW]).
727769|NCT01951573|Subjects were recruited from 1 study center located in the US.|Of the 36 enrolled, 2 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (34).
727770|NCT01951417||
727771|NCT01951391||
727772|NCT01951378||
727773|NCT01951352||
727774|NCT01951339||Patients underwent screening, as well as baseline data collection prior to randomization to group. Several patients withdrew from the study prior to randomization.
727775|NCT01951326||
727776|NCT01951261||
727777|NCT01951170||
727778|NCT01951157|69 patients were enrolled between 11/09/2013 and 2/10/2015 at 13 centers. 68 patients were treated: 22 in Arm A, 21 in Arm B, and 25 in Arm C. The first dose of the first cycle was administered on 17/09/2013 and the last dose of the last cycle was administered on 3/11/2016. The last patient, last follow-up was on 24/11/2016|
727779|NCT01951118||
727780|NCT01951105||
727781|NCT01951092|"Patients at the Immunology Center in Providence RI who were either 1) newly diagnosed, 2) returning to care after a gap, 3) or with difficulties with adherence to care were eligible for enrollment in this pilot study.
~Participants were recruited from January 2013 through July 2013 and followed for 6 months."|
727782|NCT01951066||
727783|NCT01950819|The full analysis set consisted of all randomized and transplanted patients. The safet set consisted of all patients who received at least one dose of study drug|2226 patients screened; 2037 patients transplanted and randomized to treatment.
727784|NCT01950780||
727785|NCT01950741||
727786|NCT01950663||
727787|NCT01950364|Participants took part in the study at 5 investigative sites in Belgium, Lithuania and Spain from 27 November 2013 to 16 June 2015.|Participants with a historical diagnosis of relapsed or refractory classical hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) were enrolled in 1 of 2 treatment groups: Brentuximab vedotin; Brentuximab vedotin + Rifampicin.
727788|NCT01950299||
727789|NCT01950273||
727790|NCT01950260||
727791|NCT01950078||
727792|NCT01950013|Recruiting for this study began May 1, 2013 and the final follow-up session took place on February 5, 2015. Forty-five people were recruited from a previous clinical trial on hearing aids in the lab or through newspaper advertisements and flyers.|No changes after enrollment except that 2 subjects withdrew prior to completion--see below.
727793|NCT01949870|The study was conducted at 2 study centres in Japan between October 2013 and August 2014.|
727794|NCT01949844|A total of 44 subjects with suspected coronary artery disease defined based on prior abnormal nuclear myocardial perfusion (PET/SPECT) scan or prior abnormal coronary angiogram were recruited at Cedars-Sinai Medical Center (CSMC) in Los Angeles, CA.|This pilot study did not involve evaluation of the efficacy of a drug but rather the diagnostic performance of an improved cardiac magnetic resonance imaging (MRI) technique for detection of myocardial ischemia (presence of perfusion deficits) in subjects with suspected coronary artery disease.
727795|NCT01949779|Enrollment occurred over 13 months at 7 sites in the US and 1 site in Spain. Each site was allowed to enroll up to 20 consecutive subjects. The first subject was enrolled on 12 December 2013 and the enrollment was completed on 12 January 2015. A total of 81 subjects were enrolled.|
727796|NCT01949662|Patients were recruited between 1/2014 and 6/2016 from MD Anderson Cancer Center with active cancer diagnosis, having age >=18, with Delirium with Richmond Agitation-Sedation Scale score of >=2 and receiving scheduled Haloperidol 1-8 mg/day.|3 patients were excluded before randomization. 1 died and 2 were ineligible.
727797|NCT01949545||"Participants were assigned to 1 of 4 cohorts with varying degrees of hepatic impairment defined by the National Cancer Institute Organ Dysfunction Working Group Criteria (NCI-ODWG) schema for hepatic function.
~Completed indicates participants who completed the safety follow-up visit 30 days after the last dose of carfilzomib."
727798|NCT01949532|"Participants were enrolled at 13 investigative study centers (6 in the United States, 2 in Canada, and 5 in Australia) from 29 January 2014 to 25 March 2015.
~This study is ongoing, results are reported as of the data cut-off date of 12 October 2015."|Participants with relapsed multiple myeloma were enrolled into cohorts according to renal function (normal creatinine clearance (CrCl) or end-stage renal disease (ESRD; patients on hemodialysis)). Renal function was based on calculated CrCl using the Cockcroft-Gault formula at baseline.
727799|NCT01949480|From July 1, 2013- May 29 2014, 45 patients scheduled for thoracic surgery were approached in the preoperative setting and consented for the study.|3 of the 45 consented patients were excluded because they did not meet inclusion criteria
727879|NCT01944059||Blinding information is not available from Funder, but should it become available results will be updated.
753978|NCT00452543||
727802|NCT01949155|Participants were recruited from 19 centers, 18 in the United States and 1 in Canada|Reporting group = all randomized participants (n=266). Safety analysis set = all subjects who receive study drug or sham and analyzed according to what they received. Full analysis set = all randomized subjects and analyzed according to randomized treatment regardless of the actual treatment received.
727803|NCT01949142|Participants were recruited from 29 centers, 25 in the United States and 4 from Canada.|The reporting group includes all randomized participants (n=266)
727804|NCT01949116|Total of 176 participants randomized to A5314 - 86 in LDMTX, 90 in Placebo. The first participant enrolled on January 31, 2014; the last participant enrolled on March 31, 2016. A range of 2 to 25 participants per site enrolled across 22 clinical research sites during study accrual.|
727805|NCT01949090||Out of 363 subjects enrolled in the study, 3 subjects did not receive any vaccination.
727806|NCT01949051||Participants who met the eligibility criteria at Screening were randomized to 1 of 6 treatment sequences. The treatment phase was comprised of three 7-day treatment periods, each separated by a 14- to 20-day washout period.
727807|NCT01948986||
727808|NCT01948947||
727809|NCT01948908||
727810|NCT01948830||"Patients were randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens.
~Safety set: One patient was randomized but did not receive at least one study treatment and did not record at least one post-baseline safety assessment"
727811|NCT01948791|222 patients were screened/enrolled to this study but 41 did not receive study drug.|The Intention analysis set consists of 165 patients who received at least 1 treatment & had at least 1 assessment on primary efficacy variables.
727812|NCT01948518||
727813|NCT01948388||
727814|NCT01948375|Volunteers were recruited from Guang'anmen Hospital of China Academy of Chinese Medical Sciences via poster advertisements between August 2013 and December 2013.|
727815|NCT01948310|Thirty-eight subjects were recruited for this study. One dropped out before randomization.|
727816|NCT01948258|This study was conducted by volunteers remotely and managed by the clinical department at SPD. For the study, 395 females aged between 18-45 years were recruited via internet advertising and from women who had participated in previous SPD studies. The first volunteer was recruited on 1st March 2013, the last was recruited on 1st August 2013.|Volunteers were instructed to test for pregnancy prior to starting the study. If pregnant before the start of their cycle they were withdrawn and classified as a pre-study pregnancy. Volunteers were also withdrawn if identified as health care professionals.
727817|NCT01948193|Study participants were enrolled from 19 February 2014 to 30 June 2014 at 2 clinical sites in India.|A total of 177 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
727818|NCT01948141||
727819|NCT01948076|Beginning in Septemeber 2012 all internal medicine residents at Brigham and Women's hospital were invited to participate and the first 40 residents to respond to email advertisement were enrolled.|Residents with formal ultrasound training were to be excluded but none of the potential participants had had formal training.
727820|NCT01948063||1 patient was randomized in the placebo group but the blood was accidentally thawed why this patient was excluded. 2 patients were randomized in the Ubiquinol group but never received the treatment (one because of an exclusion criteria and one because of a Boston-wide mass casualty event). These were also excluded.
727821|NCT01948050|191 subjects identified. 33 were ineligible at pre-screening; 40 not reacahble; 21 lost to follow-up; 3 deceased; 56 not interested. 38 subjects consented.|38 subjects consented; 8 screen failures; 6 never started; 24 were randomized. 1 subject withdrew after undergoing 4 of 5 tDCS/sham sessions. 23 completed randomized study.
727822|NCT01947946|The study was stopped with 13 patients randomised|
727823|NCT01947907||
727824|NCT01947894||
727825|NCT01947855||
727826|NCT01947816||A total of 1621 participants were enrolled. Among the enrolled participants, case report forms were not collected from 28 participants, and there were 1593 participants whose data in case report forms were assessable.
727827|NCT01947647||105 participants were consented and completed the intake procedures. However, of the 105 total participants, 12 participants did not met eligibility for the treatment trial and were not randomized to a treatment condition.
727828|NCT01947582||
727829|NCT01947517||
727830|NCT01947491||
727831|NCT01947335||
727832|NCT01947283|Recruitment began in August 2014 and ended in September 2016. Participants were recruited at behavioral health community clinics and psychiatric outpatient clinics in Massachusetts. Participants were assessed for eligibility and then randomized into a study arm.|Patients were excluded due to ineligibility (positive screening for mania, psychosis, and/or active suicidal ideation) or treatment discontinuation. Providers were excluded due to a lack of patients enrolled in the study. Both patient and provider study participants were excluded if they withdrew before randomization into a study arm.
727833|NCT01947153||
727834|NCT01947127|Recruitment started at April 2013 to October 2014 at King Chulalongkorn Memorial Hospital, a university-affiliated, 1,500 bed, tertiary care urban hospital|
727835|NCT01946880|Nineteen study sites in the US were activated. A total of 123 participants were screened and 102 were randomized from November 2013 to May 2018.|
727836|NCT01946542|6 participants signed consent. 4 participants were screen failures. 2 participants were randomized.|
727837|NCT01946529|Participants were enrolled at St. Jude Children's Research Hospital between December 2013 and June 2015.|
727838|NCT01946438|The study participants were enrolled from 16 to 24 September 2013 at 4 clinic centers in the United States.|A total of 208 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in the study.
727839|NCT01946425|The study participants were enrolled from 16 September 2013 to 10 October 2013 at 2 clinic centers in the United States.|A total of 60 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in this study.
727880|NCT01943864|Participants with advanced or metastatic biliary tract cancers (BTC) with unresectable measurable disease which had progressed after one gemcitabine-based chemotherapy were included in the study.|Participants meeting eligibility criteria received GSK1120212 treatment.
755540|NCT00369226||
727840|NCT01946412|This was a Phase 3, multicenter, 2 arm study in participants who received at least 1 dose of study drug in parent study VX11-770-108 (study 108) (NCT01705145).|In study VX11-770-109 (study 109) (NCT01946412), participants were to be enrolled in either ivacaftor arm or observational arm. However, there were no participants enrolled in the observational arm. A total of 33 participants were enrolled in the ivacaftor arm.
727841|NCT01946282||18,700 age-eligible patients with qualifying outpatient clinic visits were identified for invitation. 10,135 patients were excluded from participation due to the following: primary language not English or Spanish, missing contact information, incarceration, screen up-to-date, and prior history of colorectal cancer or inflammatory bowel disease.
727842|NCT01946243||
727843|NCT01946204||
727844|NCT01946191||
727845|NCT01946178|All patients underwent transabdominal uterine fibroid treatment with the Mirabilis High-Intensity Focused Ultrasound Treatment System between January 8, 2011 and November 21, 2014 at two clinical sites in Mexico. The study was completed on May 20, 2015.|Patients were screened prior to treatment for eligibility criteria including size, location, and tissue characteristics of their uterine fibroid(s). Those patients meeting the established eligibility criteria were then scheduled for treatment.
727846|NCT01946165|Patients with prostate cancer at high-risk for recurrence randomized to two treatment groups|Out of 69 participants, due to a screen failure, no arm assignment was made for 1 participant; therefore, only 68 participants were treated and evaluable for outcome analysis.
727847|NCT01946126||
727848|NCT01945996|"745 patients screened
~Excluded:
~No mobile phone = 174
~Do not know how to text = 180
~HbA1c <8 = 145
~No English or Spanish = 28
~Critically ill/AMS = 80
~Refused screening = 28"|"14 patients dropped before randomization
~Unable to identify support person = 4
~Unable to contact support person = 22
~Support person can not text = 15"
727849|NCT01945970|30 suitable subjects recruited from database|30 subjects randomised
727850|NCT01945944||
727851|NCT01945866|Phase 2 multi center randomized trial conducted at 40 US sites; 129 eyes (116 adults) with diabetes between February 2014 and December 2016. Participants with 2 study eyes enrolled one eye in each arm. Therefore, each arm includes no more than 1 study eye per participant; thus the number of eyes is equal to the number of participants in each arm.|A 12-week run-in phase was conducted to confirm that eyes with persistent diabetic macular edema (DME) still persisted after additional anti-vascular endothelial growth factor (VEGF) injections. At week 12 of the run-in phase, eyes that had received all run-in injections, and continued to meet specific criteria were eligible for randomization.
727852|NCT01945775||
727853|NCT01945710||Total 71 subjects were screened for entry into the study of which 62 were enrolled and 9 were screen failures. Of the 9 screen failures, 7 did not meet the inclusion/exclusion criteria, 1 experienced an adverse event that led to screening discontinuation, and 1 did not proceed to treatment in the study. Of the 62 enrolled, 58 subjects were treated.
727854|NCT01945593|The study was conducted at 86 centers in 23 countries between 15 October 2013 (first participant first visit) and 02 March 2018 (last participant last visit).|A total of 218 subjects were enrolled, of them 216 subjects received treatment.
727855|NCT01945489||
727856|NCT01945294|Treatment-naïve adult male and female participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection were recruited in the Asia-Pacific region.|
727857|NCT01945281|Participants less than 3 months of age with invasive candidiasis were enrolled in this study.|
727858|NCT01945242|Participants took part in the study at 252 investigative site in Japan from 25 March 2011 to 30 June 2014.|Participants with a historical diagnosis of type 2 diabetes mellitus who failed to respond adequately to treatment receiving thiazolidinediones were enrolled in 1 of 2 treatment groups as follows: alogliptin + thiazolidinediones; alogliptin + other.
727859|NCT01945216|Participants took part in the study at 608 investigative sites in Japan, from 8-July-2010 to 31-October-2015. Data reports overall population, since data not collected separately per arm as specified in protocol.|"Participants with type 2 diabetes mellitus who failed to respond adequately to diet and/or exercise therapy and α-glucosidase inhibitor were enrolled to receive Alogliptin as routine medical care. Treatments were not allocated at the start of the study. Thus, the Participant Flow cannot be presented per Arm."
727860|NCT01945138||
727861|NCT01945112||
727862|NCT01945086||
727863|NCT01945034|Study was conducted in United States from 08 November 2013 to 19 February 2015.|Out of the 348 screened participants, 304 were randomized and received treatment.
727864|NCT01945021||129 patients were enrolled and consented; there were 2 screen failures and 127 received treatment
727865|NCT01944969||
727866|NCT01944878|We analyzed the medical records of 455 hepatic vein pressure gradient (HVPG) and esophagogastroduodenoscopy (EGD) patients who had LC or chronic hepatitis in a single tertiary hospital.|800 HVPG measurement cases (Initial). Missing data (3), failure of HVPG measurements (8), cases without EGD (196); including 35 cases of patients on B-blocker, EGD over 3 months from HVPG measurement (79), incomplete EGD due to remnant food materials (19), cases having a history of gastrectomy (5), acute hepatopathy (5), and HCC (30) were excluded.
727867|NCT01944839||
727868|NCT01944774|This study was conducted in 41 research centers in China and Taiwan. Among these, 11 research centers did not enroll participants. 207 subjects were randomly enrolled in the 30 research centers.|
727869|NCT01944722||
727870|NCT01944670||
727871|NCT01944644||
727872|NCT01944631||
727873|NCT01944462|Recruitment and program coordination were completed from January to November 2014, through partnerships with local churches and senior centers.|Pre/post design (no groups). Inclusion criteria were age ≥50; able to attend a 1.5-hour session; cognitively intact (abbreviated mental test score ≥7); speak & read English at ≥4th grade (ability to read a brief passage). Additionally, program attendees wishing to participate in the study signed consent forms prior to the start of the program.
727874|NCT01944371|Of 34 participants screened for eligibility, we recruited 30 participants at The Alfred Hospital (Melbourne, VIC, Australia) and the San Francisco General Hospital (San Francisco, CA, USA) between September 24, 2013, and March 31, 2014.|
727875|NCT01944345|Multi-site recruitment with up to 1000 patients to be enrolled for entire study across all hospital or ASC sites.|
727876|NCT01944319||
727881|NCT01943825|Participants were involved in the study from 05 November 2013 to 25 November 2015 in the United States.|A total of 90 participants were enrolled and randomized in the study.
727882|NCT01943799|Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 13 September 2013. The last study visit occurred on 03 March 2015.|213 participants were screened.
727883|NCT01943591|Recruitment period: November 2013 to june 2017, from 12 centres in Canada and U.S.A.|
727884|NCT01943565||
727885|NCT01943552|192 patients were randomized in a 1:1 ratio(96 patients in each group).1 patient each in both treatment groups did not receive the treatment.1 patient, who was randomized to the placebo group, but received nebulized ipratropium bromide, so the actual numbers of patients received nebulized ipratropium bromide and placebo were 96 and 94 respectively|This was randomised, double-blind, placebo-controlled, parallel-group, multicentre trial which aims to evaluate efficacy and safety of nebulized ipratropium bromide in Chinese peri-operative patients with chronic obstructive pulmonary disease (COPD) under general anaesthesia.
727886|NCT01943539||
727887|NCT01943474||
727888|NCT01943461||
727889|NCT01943435|Participants were recruited from the general population in the City of Pittsburgh from November 2013 through November 2015.|We consented and randomized a total of 259 subjects. However, 19 of those randomized subjects who never received any treatment...i.e. they dropped out after randomization but before their first scheduled treatment. Therefore, we a total of 240 subjects who were actually enrolled and received at least one treatment.
727890|NCT01943344||
727891|NCT01943292|First subject enrolled 02Sep2013; Last subject enrolled 07Jan2014; all patients enrolled at one site in Japan.|There were no significant events and approaches for overall study. There was one screen failure.
727892|NCT01943227|Patient recruitment and informed consent will be obtained in the UCDMC perioperative suite. Recruitment will be by direct discussion between the prospective candidates and the study investigators prior to their scheduled surgical procedure. The investigators will provide the consent form in person and give subject time to discuss with family.|The screening of patients will require the investigators to access personal health information to identify prospective subjects without HIPAA authorization. The research could not be practicably carried out without this waiver of consent. The risk of harm from contacting the participants is greater than the risk of the study procedures.
727893|NCT01943110||
727894|NCT01942993||
727895|NCT01942785||Of the 55 patients enrolled, only 54 were exposed to IMP and therefore included in the all-patients-treated set (APTS)
727896|NCT01942733||
727897|NCT01942720|recruitment started on September 2013 and ended on July 2016 74 subjects enrolled within 15 sites in the US|
727898|NCT01942707|The recruitment began in october 2014 until april 2015 at Hospital Santo Amaro (private hospital), in Guarujá city, Brazil.|
727899|NCT01942694||
727900|NCT01942668||
727901|NCT01942590|17 participants signed consent; 13 participants were randomized.|
727902|NCT01942486||
727903|NCT01942161||
727904|NCT01942148||
727905|NCT01942135|The study was conducted at 144 sites in 17 countries that randomized 521 participants. Eligible participants were to have histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of recurrent (local or metastatic) disease.|The study consisted of a screening visit within 28 days before randomization, an active treatment phase, divided in cycles of 28 days each, and a post-treatment follow-up period during which survival and new anti-cancer therapy information was collected every 3 months for the first 9 months, then every 6 months from the last dose of study drug.
727906|NCT01941940||Out of a total of 288 participants screened, 60 participants were excluded due to screening failure and 1 participant did not receive study treatment based on investigator's decision. Thus, total 227 participants were included in the study.
727907|NCT01941927||
727908|NCT01941745|Recruitment spanned October 2013 - August 2017 at ICUs at Tufts Medical Center (Boston, MA), Brigham and Women's Hospital (Boston, MA), and BayState Medical Center (Springfield, MA). Three hospital sites in Poland were later added for the second high-dose/high dose placebo cohort of 44 neonates.|No washout/run-in events to report.
727909|NCT01941628|The study was conducted at a tertiary care university hospital in the period between August 2014 and September 2016.|
727910|NCT01941615|This trial was planned to include 18 healthy premenopausal female subjects. Because this trial was prematurely discontinued during the run-in period, only 16 subjects were entered.|
727911|NCT01941537||
727912|NCT01941498|Participants were recruited from 2 study centers located in the US, 1 study center located in Ireland, and 1 study center located in Germany.|Of the 104 enrolled participants, 7 were exited prior to surgery as screen failures. This reporting group includes all enrolled participants who underwent LASIK surgery (97).
727913|NCT01941485|Subjects were recruited from 1 study center located in the US and 1 study center located in Greece.|Of the 60 enrolled subjects, 1 was exited as a screen failure prior to surgery. This reporting group includes all enrolled subjects who underwent LASIK surgery (59).
727914|NCT01941472||
727915|NCT01941186|Participants were recruited from 2 urban pediatric practice sites within the Children's Hospital of Philadelphia Pediatric Research Consortium, a primary care-based network including 31 practices in 2 states, between December 2013 and September 2014.|164 parent-child dyads were assessed for eligibility and 100 were excluded. Reasons for exclusion were primarily because potential subjects either not meeting eligibility criteria (i.e., already received early intervention) or they declined to participate. 64 parent-child dyads were consented and randomized.
727916|NCT01941095|Participants were enrolled in 9 locations in Greece|A total of 100 participants were enrolled, out of which 97 participants received treatment. Analyses were performed in 97 participants.
727917|NCT01941030||
727918|NCT01940939||
727919|NCT01940900|627 patients were randomized but 1 patient was not treated|
728008|NCT01934504|Participants diagnosed with granulomatosis with polyangiitis (Wegener's, GPA) or microscopic polyangiitis, and a history positive for the presence of MPO-ANCA+ during disease flares were recruited for 3 cohorts; healthy participants were recruited for 1 cohort. Participants were recruited from 3 sites in Great Britain from Dec 2013 to Feb 2015.|
728009|NCT01934231||
727920|NCT01940887|The study was conducted at 214 centers (107 in North America and 107 in the rest of the world) in 22 countries (20 of which enrolled patients) between 19 May 2014 and 15 September 2017.|Three (3) of the 645 patients who were enrolled and randomized did not receive treatments. Remaining 642 subjects were grouped into two treatment groups (E10030 + Eylea/Avastin vs. Sham + Eylea/Avastin) for the purposes of efficacy analyses in accordance with the pre-specified study design, and the SAP.
727921|NCT01940705||
727922|NCT01940523||
727923|NCT01940510||
727924|NCT01940497||Out of 263 screened participants, 240 participants were enrolled in the study.
727925|NCT01940484||
727926|NCT01940471|Participants were enrolled at study sites in East Asia, Europe, North America, Australia, India, and New Zealand. The first participant was screened on 25 August 2013. The last Week 48 study visit for the primary endpoint occurred on 06 November 2015.|1473 participants were screened.
727927|NCT01940354|Enrollment occurred from April 2013 - November 2013. Location was Interventional Radiology Department at participating hospital.|
727928|NCT01940341|Participants were enrolled at study sites in East Asia, Europe, North America, Australia, India, and New Zealand. The first participant was screened on 12 September 2013. The last Week 48 study visit occurred on 24 September 2015.|914 participants were screened.
727929|NCT01940276||
727930|NCT01940146||
727931|NCT01940120|Patients who met eligibility criteria for the study and had a MitraClip procedure, whether a Device was implanted or not, were considered enrolled in the Registry. A total of 78 patients were enrolled at 35 North American sites. Screening period: Jan, 2007-2008. Enrollment period: Feb 14, 2007- Jan 30, 2008.|
727932|NCT01939977|94 patients were randomized, but a total of 148 patients were recruited from January 2014 to February 2015.|54 of 148 patients were excluded: 48 due to Screening failure and 6 for other reasons.
727933|NCT01939938||
727934|NCT01939899|Participants took part in the study at 11 investigative sites in the United States, Belgium, Canada, United Kingdom and Italy from 31 October 2013 to 23 March 2017.|Participants with follicular lymphoma (FL) prior to treatment were enrolled in this 2 phase study: Lead in dose finding phase in which maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ixazomib was evaluated and Phase 2 proteasome subunit beta type-1 (PSMB1) was done to evaluate the safety, efficacy, tolerability of ixazomib.
727935|NCT01939548||
727936|NCT01939496||A total of 504 participants were screened. Of which, 171 participants were randomized to study treatment. 2 participants were randomized but not dosed.
727937|NCT01939405||
727938|NCT01939366|The trial started on 27 Sep 2013 with the enrollment of the first participants and was completed on 28 Jan 2015 when the last participant completed the last follow-up examination according to the protocol.|Of the 699 participants enrolled 370 participants were not allocated (322 did not meet the eligibility criteria, 29 withdrew consent, 6 due to Adverse Events, 2 due to protocol deviations, 11 due to other reasons). 13 participants allocated to treatment were excluded from the PPS, FAS & SAF analyses populations due to GCP non-compliance at 2 sites.
727939|NCT01939314|165 Patients Identified|93 Patients Enrolled 47 Patients Excluded 25 Patients Declined
727940|NCT01939301||
727941|NCT01939288||
727942|NCT01939275||
727943|NCT01939223|This multinational study was conducted at 32 study centers that screened 65 subjects across 9 countries, between 02 December 2013 (start of enrollment) and 29 August 2016 (last patient last vist).|Overall, 65 subjects were screened, of which 40 were screen failures. The remaining 25 subjects were randomized and assigned to treatment. All 25 subjects received treatment.
727944|NCT01939197|Part 2 was not designed to test different treatments on the same subject population. Rather, the arms in Part 2 represent subpopulations with different baseline characteristics (hepatitis C virus [HCV] genotype [GT], cirrhotic status, prior HCV therapy experience). Arms F and G were randomized to regimens without and with ribavirin, respectively.|"In Part 2, participants in Arms E, F, H, I, J all had GT1 infection and received 1 consistent treatment regimen based on label recommendations; they were therefore combined and named the GT1 Analysis Group."
727945|NCT01939145||
727946|NCT01939028||
727947|NCT01939002||Of the 251 participants who entered into the run-in period of non-pegylated interferon (IFN) therapy, a total of 201 were randomized.
727948|NCT01938989|Participants were recruited from 6 study sites located in the US.|Of the 158 enrolled, 2 participants were exited as screen failures prior to randomization. This reporting group includes all randomized and treated participants (154). Note: 2 participants were randomized but not treated.
727949|NCT01938846|An open-label, Phase I, dose-finding study of BI 860585, a total of 90 patients received at least one dose of study medication.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
727950|NCT01938833||
727951|NCT01938716|Recruitment period: March 2012 to February 2015. All recruitment done at The University of Texas, MD Anderson Cancer Center.|
727952|NCT01938664||
727953|NCT01938625||The study was conducted in 2 parts (part 1 and part 2) to sequentially enroll the participants. All analyses were conducted on the overall study population (part 1 and part 2 combined).
727954|NCT01938573||
727955|NCT01938430|Participants were enrolled at study sites in the United States. The first participant was screened on 06 September 2013. The last study visit occurred on 25 March 2015.|"Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
~Cohort B: post-liver transplant, with or without cirrhosis;
~Group assignment within cohorts was based on severity of liver impairment at screening (or presence of disease for FCH groups);
~Randomization was 1:1 within groups to 12 or 24 weeks of treatment."
727956|NCT01938391||
727957|NCT01938378||
727958|NCT01938170|10/2014-1/2015|
727959|NCT01938079||
727960|NCT01938066||
727961|NCT01938040|60 patients were recruited from the Same Day Surgery Unit at three hospital locations. The dates of recruitment were from 12/1/2011 to 10/2/13.|Of the 60 patients randomized 5 did not receive study medication. The surgical case was either cancelled or the subjects withdrew consent.
727962|NCT01938001|358 participants were randomized into the study from sites located in Belgium, Brazil, China, Czech Republic, France, Germany, Israel, Italy, Japan, Poland, Portugal, Russia, Spain, Turkey and the United States.|"Participants were stratified by the following:
~previous rituximab treatment (yes, no)
~time since last anti-lymphoma therapy (≤ 2, > 2 years)
~disease histology (follicular or marginal zone lymphoma)"
727963|NCT01937975|After enrollment of participants with End Stage Renal Disease and Severe Renal Impairment, healthy participants with matching mean age, body mass index, and gender were enrolled.|
727964|NCT01937871||
727965|NCT01937715||
727966|NCT01937624||
727967|NCT01937598||
727968|NCT01937559|122 patients were enrolled and randomized into one of two groups: tranexamic acid administered topically and saline administered topically (control). 61 patients were enrolled in each of the two groups. In addition, 66 patients who received tranexamic acid intravenously were retrospectively analyzed as a comparative group.|
727969|NCT01937520|Participants were recruited in a Same Day Surgery Suite at a academic medical center. The first participant was enrolled on 7/2/13 and last patient enrolled on 7/15/14.|
727970|NCT01937507||
727971|NCT01937390||A total of 645 subjects were screened in this study, out of which 585 satisfied the selection criteria and were finally entered in to the study.
727972|NCT01937364||
727973|NCT01937351||
727974|NCT01937312|Participants were recruited and enrolled from 30 investigative sites located in the US.|Of the 282 enrolled, 93 participants were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants (189). Note: One subject randomized to SIMBRINZA® Suspension was not exposed to investigational product.
727975|NCT01937299|Participants were recruited from 32 investigational centers located in the US.|Of the 307 enrolled, 74 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (233).
727976|NCT01937260||
727977|NCT01937195|Patients were enrolled from April 2013 through June 2014. Patients were admitted to the inpatient units at Evangelical Community Hospital.|
727978|NCT01937130|In total, 33 subjects were screened at 14 sites, and 23 subjects were randomized to one of the 4 treatment arms.|23 subjects were randomized but 21 subjects received treatment. 1 subject lost due to death and 1 subject lost due to withdrew of consent. 7 subject of 21 completed the treatment phase (Day 28). 4 of 3 completed the two follow-up phone calls made at Months 3 and 6. 14 subjects discontinued the study early.
727979|NCT01937117||
727980|NCT01937026||This was an open-label, 2-period, fixed-sequence study.
727981|NCT01936974||
727982|NCT01936909||
727983|NCT01936896||
727984|NCT01936870||
727985|NCT01936857||
727986|NCT01936844||
727987|NCT01936662|Patients were recruited on the day of their scheduled endoscopic procedure in the outpatient clinic of a large children's hospital.|Patients were pre-screened for allergies to medications used and BMI's outside the 90th percentile. All other patients were eligible for enrollment.
727988|NCT01936649|The study was conducted at 10 centers in US. A total of 63 participants were enrolled in the study between 16 August 2013 and 20 February 2014.|Out of 63 enrolled participants, 51 received at least 1 administration of AdreView (Iobenguane I 123 injection) and 50 participants received 2 administrations of AdreView. Myocardial AdreView uptake over time was quantitatively measured via planar and single photon emission computed tomography (SPECT) imaging at various time points post-injection.
727989|NCT01936623||
727990|NCT01936467|Patients were enrolled between September 2013 and December 2014 in two tertiary academic centers|Patients were excluded from the study because a predominantly cystic lesion was found; the lack of an appreciable mass at EUS, unavailable on-site pathology and respiratory distress precluding completion of the examination
727991|NCT01936389||
727992|NCT01936363|First/last participants (informed consent): Sep 2013/Oct 2014. Clinical data cut off: Jan 2018.|
727993|NCT01936324||
727994|NCT01936259|"Due to competitive enrollment, one extra shoulder was randomized and enrolled into the study in the Control group as the site was not aware the study had reached full enrollment.
~258 individual subjects were enrolled in the study. 7 subjects underwent study procedures bilaterally, resulting in 265 shoulders enrolled in the study."|Subjects were randomized 1:1 to either the Comprehensive Shoulder System with Nano Humeral Component (Investigational) or the Comprehensive Shoulder System with Mini Humeral Stem (Control). Treatment assignments occurred intraoperatively and subjects remained blinded until completion of two-year follow-up for all subjects.
727995|NCT01936181||
727996|NCT01935947||There were seven screen failures.
727997|NCT01935934||
727998|NCT01935700|from 2013-6-6 to 2019-5-31 in Kaohsiung Medical University Hospital total 15 participants were included for screening, one screening failure, 14 participants received colchicine management|one screening failure dut to active gastrointestinal hemorrhage
727999|NCT01935622||
728000|NCT01935180||
728001|NCT01934972|Study recruitment ended early due to the PI leaving the institution where the research was being completed (i.e., University of Arizona). Thus, only 23 people were enrolled in the study.|Six individuals of the 30 who were screened were not assigned to either of the intervention conditions. Four of these individuals dropped out prior to randomization to study arm. One was excluded due to an uncontrolled eating disorder, and one was excluded due to kidney dysfunction.
728002|NCT01934894|Between May 2014 and July 2015, 11 subjects with HER2-positive metastatic breast cancer and central nervous system (CNS) metastases were enrolled at 4 investigational sites in the U.S. The study was designed to define the optimal dose of study drugs to administer to subjects, then further assess intracranial response.|
728003|NCT01934790|Overall, 59 participants were screened in 7 countries worldwide, from 22-Dec-2013 (first patient first visit) to 12-Apr-2017 (last patient last visit).|The study was conducted at 16 study centers that screened 59 participants. Of them, 14 were screening failures and the remaining 45 participants were assigned to treatment.
728004|NCT01934647||
728005|NCT01934582||
728006|NCT01934556||
728007|NCT01934517||
728010|NCT01934218||
728011|NCT01934192|A total of 92 participants between 18 to 85 years of age who were admitted to Intensive Care Unit (ICU), mechanically ventilated and who received enteral nutrition (EN) were included in this study.|The study consisted of a screening phase, a treatment period of up to 7 days and a post treatment safety follow-up of 14 days after the last dose of study medication. After performing Baseline tests eligible participants were included in the study.
728012|NCT01934140|Enrollment for this study (MENACWY-TT-99) started at Year 6 post primary vaccination in study 107386 [NCT00356369]. However, as approval was not obtained from authorities until after end of Year 6, hence no planned activities was done for Year 6.|In this study, participants from the study 107386 [NCT00356369] were followed up for assessment of persistence of immune response. And those who consented received booster vaccination and were followed up for another 6 months.
728013|NCT01934010|A total of 260 subjects were enrolled and 257 subjects were treated in overall 59 active sites in Canada (6), the United States (35), the Czech Republic (7), Israel (2), Turkey (3) and Republic of South Korea (6). Subjects could only participate if they had been previously enrolled and completed the participation in the TACTT2 study.|"Main Inclusion Criteria:
~completion of TACTT2 study
~negative pregnancy test (women of childbearing potential)
~willing and able to attend the study visits during at least one treatment cycle."
728014|NCT01933984||
728015|NCT01933932|This study started with an assessment visit where a tumour KRAS mutation assessment was performed, eligibility assessments were performed and informed consent obtained. Eligible patients were randomised at the next visit. Patients then received double-blinded study treatment, were seen and assessments performed until objective disease progression.|Eligible patients randomised in a ratio of 1:1 to receive selumetinib (AZD6244; ARRY-142886) 75 mg bd in combination with docetaxel 75 mg/m2 or placebo in combination with docetaxel 75 mg/m2. They were stratified based on their WHO performance status and tumour histology. 510 patients enrolled and 510 randomised.
728016|NCT01933919|This study was conducted at 34 clinical sites in Japan.|Eligible participants were randomized to placebo or fluvoxamine in a 1:1 ratio. Randomization was stratified by prior fluvoxamine treatment and age (6-11 years or 12-18 years).
728017|NCT01933880||
728018|NCT01933789|CLINICIANS and INTERPROFESSIONAL (IP) TEAM recruited from Feb 2014 to Nov 2015. PATIENTS and FAMILY recruited from Mar 2014 to Jun 2016. Potential subjects received introductory letters and phone calls to assess interest and eligibility. INTERVIEWEES were selected via purposive sampling from those who completed the intervention activities.|635 CLINICIANS assessed for eligibility; 503 excluded; 132 enrolled. Unit of randomization was clinician. 11 IP TEAM members identified; 4 enrolled. 1113 PATIENTS assessed for eligibility; 576 excluded; 537 enrolled. 142 FAMILY identified; 23 excluded; 119 enrolled. Subjects were enrolled if they completed a baseline survey prior to target visit.
728019|NCT01933776|The study participants were enrolled from 27 August 2013 through 08 October 2013 at 1 clinic center in China.|A total of 40 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in this study.
728020|NCT01933672|A total of 90 participants with type 2 diabetes mellitus (T2DM) consented for this study; of these, 47 participants were ineligible at screening visit, 43 (47.8%) transitioned into run-in phase where participants were standardized on Sponsor-provided metformin.|A total of 33 (33/90; 36.7%) participants completed metformin run-in period and were randomized and received to at least one regimen (PF-04937319 split-dose, PF-04937319 once daily, or sitagliptin).
728021|NCT01933594||
728022|NCT01933464||
728023|NCT01933425|"Carried out between November 2013 and April 2014. Center for Minimal Invasive Gynaecology, Aleris-Hamlet Hospital Copenhagen, Denmark.
~A total of 25 patients were eligible in the study period, of which nine declined to participate, and two were excluded due to the fact that they did not speak Danish. All 14 patients completed the study"|
728024|NCT01933399||
728025|NCT01933334||
728026|NCT01933243||
728027|NCT01933230||
728028|NCT01933217|Recruitment period for the study was January 2014 through July 2017. Participants were recruited from a tertiary pediatric hospital in the Midwestern United States with a Level 1 trauma designation. 321 participants were screened for eligibility.|Of the 321 assessed for eligibility, 40 participants scheduled a baseline assessment. 163 did not meet inclusion criteria and 118 declined to participate. 26 of the 40 participants were enrolled and randomized. Of those not randomized, 5 dropped before baseline visit and 9 did not show for scheduled baseline visit.
728029|NCT01933113||
728030|NCT01933048|Recruitment and enrollment was conducted in San Antonio, Texas and San Diego, California.|
728031|NCT01932996||
728032|NCT01932970|"This study was conducted at 33 centers in the United States. Participants were enrolled from 1 September 2013 to 9 December 2013.
~Participants were required to be on a stable dose of daily oral cinacalcet for a minimum of 4 weeks before screening, and during the 4 weeks of screening."|Upon enrollment, participants underwent a washout period of a minimum of 7 days, wherein no cinacalcet use was allowed. Participants who had a serum corrected calcium ≥ 8.3 mg/dL during the washout period entered the treatment phase and were categorized based on their pre-washout, screening cinacalcet daily dose level (30 mg, 60 mg or ≥ 90 mg).
728033|NCT01932788||
728034|NCT01932762||98 participants were assigned to treatment at 28 sites worldwide and all enrolled participants received ≥1 dose of study therapy. 30 participants enrolled in Part A and 68 were enrolled and randomized in Part B of the study. Enrollment in Part C, an evaluation of a fixed-dose combination of grazoprevir and elbasvir, was never initiated.
728035|NCT01932697||
728036|NCT01932606|Subjects were enrolled in the trial between January and September 2014.|
728037|NCT01932437|Study started July 26, 2013. Study completed July 03, 2014. Conducted at a Phase 1 Clinical Research Unit|
728038|NCT01932294||
728039|NCT01932242||
728040|NCT01932164|the recruitment of 5 patients was performed at dentistry department of Hospital Menino Jesus between june and august 2013.|
728041|NCT01932112||
728042|NCT01932060||
728119|NCT01927718|Recruitment Period: January 2014 to august 2016. All recruitment done at The University of Texas MD Anderson Cancer Center.|
728120|NCT01927627||
730382|NCT01769105||Five patients had been enrolled in the study, but withdrew their participation after baseline examination for personal reasons. They did not receive any treatment.
728043|NCT01931956|As of February 13, 2018, a total of 59 Compassionate Use and 7 Emergency Use patients have undergone MitraClip procedure between 14 Dec 2010 and 22 Feb 2013. A total of 628 patients in the High Risk arm between January 22, 2009 and December 19, 2013 and 271 patients in the Non-High Risk arm were enrolled between January 22, 2009 and April 14, 2011.|Patients who did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either EU or CU.
728044|NCT01931878||
728045|NCT01931865||
728046|NCT01931839|Study conducted in 2 parts: A & B. Part A consisted of Treatment Cohorts & Observational Cohort, which enrolled participants from Study VX12-809-103 (Study 103, NCT01807923) & Study VX12-809-104 (Study 104, NCT01807949). Part B consisted of Treatment Cohorts which enrolled participants from Cohort 4 of Study VX09-809-102 (Study 102, NCT01225211).|Of 1164 participants enrolled, 1163 were dosed and included in this study.
728047|NCT01931735||
728048|NCT01931709||
728049|NCT01931670|Participants were randomized at 187 sites in Argentina, Austria, Australia, Brazil, Czech Republic, Hungary, Italy, New Zealand, Poland, South Africa, Spain, the United States, and the United Kingdom.|The study consisted of 4 periods: a Washout Period (if applicable); a Screening Period of ≤ 100 days prior to first dose; a 6-month Treatment Period; and a Post-Treatment Follow-up Period of ≤ 12 months (if applicable). Participants were randomized into the study in a 3:2:2 ratio to placebo, elagolix 150 mg QD, or elagolix 200 mg BID, respectively.
728050|NCT01931566|Participants took part in the study at 57 investigative sites in United States, United Kingdom, Germany, Australia, and Switzerland from 01 Aug 2013 to 06 Sep 2018.|Participants at least 65 years old with normal cognitive function were enrolled to receive either pioglitazone (0.8 mg sustained release tablet) or placebo.
728051|NCT01931527||
728052|NCT01931475||
728053|NCT01931462||
728054|NCT01931397||
728055|NCT01931202||138 subjects signed consent, 108 were randomized to one of the 3 arms therefore they cannot be classified to any of the below arms.
728056|NCT01931150||
728057|NCT01931098||
728058|NCT01931059|Recruitment was done between 9/4/2013 and 9/19/2014 at the Department of Research at the Zucker Hillside Hospital.|Subjects were immediately randomized to either Arm 1 or Arm 2.
728059|NCT01930890||
728060|NCT01930799||
728061|NCT01930747|study is performed in operating theatre of one center: and one campus: campus Brugge, center: AZ SINT JAN Brugge-Oostende. study is performed on patients requiring laparoscopy for bariatric surgery.|8 patients were excluded from randomization due to movements and impossibility to measure abdominal compliance before randomization.
728062|NCT01930643||
728063|NCT01930487|47 patients were recruited for the study|1 subject started but did not complete the baseline examination and was not randomized to either treatment arm.
728064|NCT01930435||
728065|NCT01930214|Enrollment was completed at 350 treated subjects.|A subject was considered enrolled when a signed informed consent was in place, all inclusion/no exclusion criteria were met, and the study guidewire had crossed the target lesion.
728066|NCT01930188|The trial was conducted at 124 sites in 18 countries: Argentina: 4; Bulgaria: 10; Czech Republic: 5; Hong Kong: 1; Hungary: 4; India: 11; Japan: 14; Mexico: 5 Norway: 5; Portugal: 6; Romania: 5; Russian Federation: 17; South Africa: 7; Spain: 7: Sweden: 4; Thailand: 4; Turkey: 9; and Ukraine: 6 sites.|
728067|NCT01930175|A total of 13 participants were enrolled and randomized into the study from Austria (1 center); Bulgaria (1 center); Taiwan (1 center); USA (2 centers).|The study was planned to be conducted in approximately 32 patients. However, after enrolling 13 patients, the recruitment was terminated due to strategic reasons related to the development of the compound.
728068|NCT01930162|Patients were enrolled into the study until approximately nine (9) patients were evaluable for safety as measured by the absence of infusional toxicity and sustained engraftment at Day 100.|
728069|NCT01930058||
728070|NCT01930045||
728071|NCT01929993|Women who needed type 3 excision of the Transformation Zone referred to a colposcopy clinic in Rio de Janeiro, Brazil, after cytological screening between January 2008 thru December 2011.|
728072|NCT01929980||
728073|NCT01929889|The study target enrollment goal was 20 completed subjects.|19 subjects were consented and completed the study screening visit.11 subjects did not start on the treatment after signing the consent form. The most common reason for early termination was disagreement between the subjects' self-reported diagnosis and the diagnosis obtained by the research psychiatrist.
728074|NCT01929876||
728075|NCT01929863|The study was planned on 16 participants with Type 2 diabetes mellitus (T2DM), aged 30 to 64 years, at a single center of United States from 22 August 2013 to 21 November 2013.|A total of 15 participants were randomized in the study and entered a run-in period where participants were administered oral dose of metformin 850 milligram (mg) tablet twice daily (BID) for 14 days, after which they entered the 2 double blind treatment periods in a crossover manner.
728076|NCT01929759||
728077|NCT01929707||This was a single-dose, incomplete-crossover, dose-escalation study with minimum 7 days between dosing periods. Each participant received either 2 topical doses of LY3050258 or 1 topical dose each of LY3050258 and placebo. Two discontinued participants completing Period 1 were replaced in Period 2.
728078|NCT01929681|Recruitment was performed through newspaper advertisement, posting, and referral|Subjects that failed exclusion criteria for variable criteria such as medications change or drug use were permitted to reapply for participation after a washout period of at least 1 month.
728079|NCT01929473||
728080|NCT01929460||
728081|NCT01929408||
728082|NCT01929395||No participants from Phase 1 participated in Phase 2
728083|NCT01929343||84 participants were consented to participate in the study. 48 were withdrawn as they did not meet inclusion/exclusion criteria (insufficient use of cocaine, medical concerns, positive drug screens or psychiatric disorders) upon further screening and evaluation. Thus, we are reporting on 36 participants.
728201|NCT01921829|Patients were recruited from the UPMC Heart Failure and Cardiology services, from July 2015-Nov 2016.|One participant was enrolled but withdrew consent before receiving any randomized treatment protocol. Therefore, that patient was withdrawn.
730383|NCT01768858||All enrolled participants
728084|NCT01929317|A total of 81 participants (par.) were randomized, of which 71 participants completed the Dose Increase Effect Verification (DIEV) Phase and 62 participants entered the Long-term Phase and 39 participants completing the Long-term Phase.|This study was comprised of a Screening Phase (4 weeks), DIEV Phase (12 weeks), Down Titration 1 Phase (1 week), Long-term Phase (39 weeks), Down Titration 2 Phase (1 to 2 weeks) and the Follow-up Phase. The first 60 par. who completed the DIEV phase entered into the Long-term phase after a completion of the Down Titration 1 phase.
728085|NCT01929291|A total of 682 subjects case report forms were retrieved during the post-marketing surveillance period. Among those, 672 subjects were assessed for safety and the safety data from 10 subjects who did not fulfilled inclusion/exclusion criteria were analyzed separately.|
728086|NCT01929226||
728087|NCT01929135|"The investigation was conducted at the Department of Periodontology of Universidad de Los Andes.
~Patients were enrolled in the study between June 2013 and August 2013, derived from the Health Care Center, Universidad de los Andes (San Bernardo, Santiago, Chile)."|
728088|NCT01929109||This study consisted of 5 groups: Group 1-4 (Normal Renal Function Control, Mild, Moderate and Severe Renal Impairment) and Group 5 [End-stage Renal Disease (ESRD)].
728089|NCT01929083|Subjects recruited from a) INResearch database, maintained by Indiana Clinical Translational Research Institute (CTSI), and b) Hard copy and electronic advertisements on the IUPUI and Purdue University campuses Participants were recruited between October 2012 and February 2014|n=333 subjects assessed for eligibility; n=27 consented, n=306 excluded (n=108 did not meet inclusion criteria, n=198 declined to participate); of n=27 consented, n=19 enrolled, n=8 excluded because they met one or more exclusion criteria
728090|NCT01929057||
728091|NCT01929044|299 patients were entered and 295 were treated.|
728092|NCT01929031||
728093|NCT01929018||No significant study events occurred after participants were enrolled, but before they were assigned to a study group.
728094|NCT01928940||This study consisted of 2 parts: Phase I part included Japanese participants (par.) with BRAF V600E/K mutation-positive advanced solid tumors and the Phase II part included Japanese par. with BRAF V600E/K mutation-positive cutaneous melanoma.
728095|NCT01928927|58 participants enrolled to Step 1 between January 6, 2014 and April 13, 2015. Step 1 was a run-in period to ensure successful pre-randomization biopsies were obtained. 44 participants did have successful Step 1 biopsy and were randomized to Step 2 between January 13, 2014 and April 22, 2015.|All participants enrolled to Step 1. Participants with successful Step 1 biopsies and eligible for Step 2 were randomized to the two study arms using a 2:1 allocation ratio with permuted blocks of size 3 and without institutional balancing. There was no stratification.
728096|NCT01928862|Participants were recruited at 9 investigative sites in the United States (US).|Eighty participants were screened out of which 78 participants were randomized in this trial. Two were screening failures (participant not fulfilling inclusion/exclusion criteria [n=1], other [n=1]).
728097|NCT01928849||
728098|NCT01928797|Start Date: November 2013 Types of location: Brigham and Women's Hospital Labor and Delivery Unit|
728099|NCT01928771||2681 participants signed informed consent form, 2232 participants entered screening/run-in period,1205 participants were randomised to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 1205 patients randomised, 1204 patients received treatment with the study drug.
728100|NCT01928758||27 participants attended Visit 1 and consented but did not meet final eligibility criteria. The remaining participants (n=218) began a baseline phase during which 30 participants were lost to follow up or withdrawn from the study before being randomized to the study intervention. 188 participants were randomized into an intervention.
728101|NCT01928719||Participants completed a baseline phase of one week on usual brand cigarettes and another baseline phase on same nicotine content cigarettes (2 weeks). Of these, 35 participants either were lost to follow up or withdrawn from the study during the baseline phase and before they started the intervention.
728102|NCT01928693||
728103|NCT01928680||
728104|NCT01928615||Neither of the 2 enrolled participants were randomized to 1 of the 2 crossover treatment arms. Randomization would not have occurred until after Cycle 6. Both participants only received 1 cycle of treatment.
728105|NCT01928485||
728106|NCT01928472|Subjects were recruited from 6 centers in United States.|All enrolled subjects were included in the trial.
728107|NCT01928433||
728108|NCT01928394||1131 participants were treated in total for TNBC, GC, PC, SCLC, BC and OC.
728109|NCT01928381|143 adults with painful diabetic neuropathy were screened, in a total of 146 screenings, 83 met eligibility criteria and entered Pain Training - Part 1. To be randomized into Part 2 (3 period treatment crossover study), participants had to successfully complete Part 1 Pain Training and meet all study entry criteria at Visit 6 (~Day 36) .|Crossover data starting with First Intervention excludes 3 participants who were randomized but not treated in the double-blind crossover periods. The 3 are included as withdrawals in Part 1 - Placebo run-in (single blind) period.
728110|NCT01928329||
728111|NCT01928290|The study opened to participant enrollment on 11/08/2013 and closed to participant enrollment on 07/23/2018.|
728112|NCT01928225||
728113|NCT01928186||
728114|NCT01928082||
728115|NCT01928030||
728116|NCT01927887|The proposed accrual goal for the study was to enroll 20 patients, who meet the inclusion criterion. 12 patients who met criteria were identified, enrolled and completed study as outlined in the protocol|
728117|NCT01927861|The trial was conducted at 26 sites in Japan.|Participants were assigned to treatment for 104 weeks in the pivotal phase and for further 104 weeks in the extension phase and were offered to continue treatment in the extended treatment phase for 26 weeks.
728118|NCT01927757|"This study was conducted at 30 centers in the United States and Canada. Participants were enrolled from 06 May 2013 to 02 December 2014.
~Patients with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost satisfactory response to adalimumab when used as the first biologic agent in combination with methotrexate were eligible."|A total of 90 participants were enrolled in the study, however, 4 participants from 1 site were excluded from all efficacy analyses due to good clinical practice (GCP) violations. Three of these participants who received etanercept are included in safety results.
730384|NCT01768832||
730385|NCT01768676||
728121|NCT01927575|Subjects who present for, are undergoing, or have undergone 'standard of care' general x-ray and CT or MRI examinations, which meet all of the study enrollment criteria, may be approached and enrolled. Each subject would then have a 3rd image taken using Fujifilm's Digital Radiographic AcSelerate CsI System with Tomosynthesis.|Subjects are recruited as long as they had either an x-ray and CT or an x-ray and MRI, and sign a consent to have a third image taken with Fujifilm's Digital Radiographic AcSelerate CsI System with Tomosynthesis.
728122|NCT01927562||A screening endoscopy is performed to visually examine the participant's GI tract to ensure they meet the requirements of the exclusion criteria concerning anatomical anomalies that would preclude the ability to complete the treatment. A biopsy is also taken to evaluate the baseline tissue.
728123|NCT01927419||Of 179 participants enrolled, 142 (95 in the nivolumab + ipilimumab group and 47 in the ipilimumab group) were randomized, and 140 (94 in the nivolumab + ipilimumab group and 46 in the ipilimumab group) received treatment.
728124|NCT01927367||One participant did not meet inclusion criteria and was excluded from the analysis.
728125|NCT01927120|Participants were enrolled at Moffitt Cancer Center, April 2014 through December 2015.|
728126|NCT01927055|61 patients enrolled in the open-label dose titration, 16 patients discontinued in the open-label period and 45 patients continued on to the randomized double-blind treatment period.|
728127|NCT01926977||
728128|NCT01926886||Participants with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (eBC) who completed the first 6 cycles of trastuzumab intravenous (IV) as part of the (neo)adjuvant treatment received 12 cycles of trastuzumab to complete a total of 18 cycles of trastuzumab were enrolled.
728129|NCT01926782|The study was conducted at 97 sites in 8 countries. A total of 1491 subjects were screened between September 2013 and April 2014, 688 of whom were screen failures. Screen failures were mainly due to inclusion criteria not met.|Randomization was stratified according to statin therapy (with/ without) and cardiovascular risk (moderate vs. high/ very high) within the population receiving concomitant statin. Assignment to treatment arms was done using an Interactive Voice/Web Response System in 2:1:4 (Placebo: 75 mg: 300 mg) ratio after confirmation of selection criteria.
728130|NCT01926626||Of the 76 participants who were enrolled, 38 participants attended Study Session 1: 1 participant voluntarily withdrew prior to Study Session 1, 3 participants were lost to contact prior to Study Session 1, and 34 were withdrawn from the study by the PI or medical staff because they did not meet inclusion criteria or met exclusion criteria.
728131|NCT01926509||
728132|NCT01926496|The clinical trial was performed at 44 sites in 3 countries: France, 11 sites; Germany, 15 sites; and United Kingdom, 18 sites|
728133|NCT01926444|First patient enrolled: 25 JULY 2013; Last patient completed: 03 MARCH 2014|A total of N=37 subjects were screen failures and were not randomized (total randomized = 271/308). Of those randomized, N=268 subjects received at least one dose of study drug, and were included in the Safety Population.
728134|NCT01926119||
728135|NCT01926028||
728136|NCT01926015||
728137|NCT01925989||
728138|NCT01925950||
728139|NCT01925781||
728140|NCT01925768|The study consisted of a 24-week randomized, double-blind, placebo-controlled treatment phase, followed by a 28-week active treatment phase and a 52-week open-label extension phase, for an overall study duration of 113 weeks. 219 subjects were enrolled from 59 centers across 10 countries.|Randomized participants were stratified by their baseline prednisone use (yes or no) and by their previous disease modifying antirheumatic drug (DMARD) use (excluding biologics). Participants were allowed to take non-steroidal anti-inflammatory agents and/or low dose corticosteroids during the study.
728141|NCT01925703||
728142|NCT01925677||
728143|NCT01925612||Two patients enrolled but did not receive treatment.
728144|NCT01925469||
728145|NCT01925417|Recruitment was from 07/15/13 to 12/16/13 at 13 medical clinics in the United States. Recruiment was performed by trained investigators and study coordinators.|
728146|NCT01925404|Parks are the unit of analysis; Parks were randomly assigned to the study arms|
728147|NCT01925339||
728148|NCT01925274||
728149|NCT01925209|Participants were randomized into one of the four treatment arms in a 1:1:1:1 ratio.|The study included 4 epochs: screening (up to 28 days pre-treatment), treatment (from day 1 up to 52 weeks), treatment maintenance (from week 52 up to 104 weeks) and follow-up (28 days after last dose administration).
728150|NCT01925183||
728151|NCT01925170|Women for the Part B low dose study were enrolled between 5/11/2009 and 3/8/2012.|
728152|NCT01925144||This was an open-label, 2-period, fixed-sequence study.
728153|NCT01925014|From 20 Korean teaching hospitals with predominantly limited experience in low-dose CT|
728154|NCT01924988||
728155|NCT01924975||
728156|NCT01924949|Participants were enrolled at 1 study site in the United States. The first participant was screened on 29 July 2013. The last study visit occurred on 18 August 2014.|8 participants were screened.
728157|NCT01924871||
728158|NCT01924845||The study consisted of a 31-day Screening and Baseline Period (26-day Screening Period, a 5-day Baseline/Enrollment Period), a 24-week Treatment Period, and a 30-day Safety Follow-up Period. Following the Screening and Baseline assessments, qualified subjects were enrolled in the study.
728159|NCT01924806|Sixty (60) subjects were to be randomized in a 1:1 ratio. A total of 11 subjects were enrolled at 1 investigative site by 2 investigators.|Overall, 9 subjects received treatment for a total of 9 wounds treated. Two of the enrolled subjects, discontinued prior to treatment.
728160|NCT01924767|This Phase I trial was randomised, double-blind, and placebo-controlled within dose groups. It was to be performed in 48 female and male patients with type 2 diabetes in 4 sequential groups of 12 patients each. Within each dose group, 9 patients were to receive active drug and 3 were to receive placebo.|14 days wash-out of previous antidiabetic therapy followed by 8 days of once daily dosing at each dose level.
728202|NCT01921751||Patients were registered and received 3 cycles of Gemcitabine/nab-Paclitaxel and then had central SMAD4 testing done. Patients then had a CT/MRI of their abdomen/pelvis for restaging. Only non-progressing patients were then randomized after being stratified by carbohydrate antigen 19-9 (CA19-9) and SMAD4.
728203|NCT01921634||
728161|NCT01924689|This study was conducted at 7 study centers in the United States. A total of 24 patients were enrolled at 4 study centers. Three study centers did not enroll patients.|Patients who provided informed consent underwent screening procedures within the 21 days preceding C. novyi-NT (Clostridium novyi-Non-Toxic) spore administration. Patients reported to the clinical site 24 hours prior to study Day 0 to reconfirm eligibility and for baseline assessments. Assessments were done as per the schedule of assessment.
728162|NCT01924559||
728163|NCT01924533||The number of participants in the participant flow (525) includes all participants who were eligible and assigiend to each treatment group.
728164|NCT01924442||
728165|NCT01924429||
728166|NCT01924390||
728167|NCT01924364||
728168|NCT01924299||This was an open-label, 2-period, fixed-sequence study. Period 1 was from Day 1 through Day 2. Period 2 was from Day 3 through Day 9 for baricitinib + ketoconazole (Group A) and Day 3 through Day 10 for baricitinib + fluconazole (Group B).
728169|NCT01924182|Seven participants were enrolled (consented).|Of the 7 participants that were enrolled, 3 met the randomization eligibility and were randomized to the IT Group. Of the 3 participants randomized, 2 were implanted.
728170|NCT01924169|November 2014 through May 2016. All of the participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.|
728171|NCT01923961||
728172|NCT01923896|Participants were enrolled beginning in April 2013 through July 2013|
728173|NCT01923805||
728174|NCT01923740|The enrollment of the ABSORB China RCT began on July 31, 2013 & completed on March 13, 2014 with the first subject randomized on 2 August 2013. A total of 480 subjects (Intent-to-treat (ITT) population) were randomized (Absorb BVS:241&XIENCE:239) at 24 clinical sites in mainland China. Last subject completed the 5 year follow-up on March 7, 2019.|Of the 480 ITT subjects, 21 were excluded from the PTE population due to pre-specified protocol/treatment deviations or due to subject withdrawal prior to any study device attempts during the index procedure. Thus, of the 459 subjects in the PTE population, 227 were randomized to the Absorb BVS arm and 232 were randomized to the XIENCE V arm
728175|NCT01923480||
728176|NCT01923467||
728177|NCT01923428||
728178|NCT01923389||
728179|NCT01923363||438 obese patients receiving P-T were screened between June 2013 and January 2016. 67 patients fit inclusion criteria - 12 chose not to participate in the study or informed consent could not be obtained; 9 were excluded due to refusal of the primary care team; 13 had P-T discontinued prior to enrollment; and 4 were included previously in the study
728180|NCT01923311|Participants were enrolled at study sites in North America, Europe, Asia, and Africa. The first participant was screened on 26 August 2013. The last study visit occurred on 03 November 2017.|"48 participants were screened.
~The study was discontinued after enrollment of only Cohort 1, Part B and Cohort 2, Part A. The study close-out was triggered by the voluntary withdrawal of single-agent Vitekta® sale based solely on low utilization of the product, and was not a result of any ongoing or new safety issue."
728181|NCT01923285||
728182|NCT01923181|The trial was conducted at 100 sites in 14 countries as follows: Austria (6), Bulgaria (3), Canada (6), Denmark (6), Germany (6), Israel (6), Italy (4), Malaysia (4), Serbia (1), South Africa (3), Spain (5), Sweden (3), United Kingdom (8) and United States (39).|"Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product."
728183|NCT01923168|A total of approximately 320 patients were planned to be randomized: this was based on 60 patients per arm in each cohort (PIK3CA mutant and PIK3CA wild-type) for the alpelisib+letrozole and placebo+letrozole arms, plus the estimated number of patients randomized to buparlisib+letrozole arm at the time this arm was discontinued.|
728184|NCT01923129||5 subjects were excluded.
728185|NCT01922986||
728186|NCT01922934||
728187|NCT01922739|A total of 183 patients with moderate to severe chronic low back pain completed Study 3103 and were screened and eligible for enrollment into this study. One patient chose not to participate prior to enrollment.|Of the 182 participants who enrolled into Study 3104, 26 participants enrolled under the original protocol and 156 participants enrolled under the amended protocol.
728188|NCT01922349||
728189|NCT01922336||
728190|NCT01922271||
728191|NCT01922258|The trial was conducted at 62 sites in 9 countries: Bulgaria, Canada, Finland, France, Russia, Slovenia, Ukraine, the United Kingdom (UK), and the United States (US) and 270 participants were randomized. The date of the first ICF signed by a participant in this trial was 28 October 2013 and the date of the last trial observation was 30 March 2017.|The screening period ranged from 2 to 42 days (with an option to extend with approval of the medical monitor). The screening period was to determine the participant's eligibility and to washout prohibited concomitant pharmacotherapy prior to randomization.
728192|NCT01922219||
728193|NCT01922115||
728194|NCT01922102|Randomized Set: consisted of all randomized patients. Patients were considered randomized when they had been given a randomization number.|In total, 457 patients were randomized into this study in a ratio of 2:2:1: 182 to Group I, 184 to Group II, and 91 to Group III.
728195|NCT01922089||
728196|NCT01922050||
728197|NCT01922037||Results are reported by age group (adult participants and adolescent participants) as well as for all participants.
728198|NCT01922024||
728199|NCT01922011||
728200|NCT01921894|Subjects were enrolled from: 1) the Emergency Department of Children's Hospital of Pittsburgh (CHP), 2) the Pulmonary Medicine and Allergy clinics of CHP, 3) the General Pediatric Clinics of CHP, and 4) participants in a prior study of the Pediatric Environmental Medicine Center of CHP (who had consented to be contacted about studies of asthma).|We recruited 48 children who met initial inclusion/exclusion criteria. Of these 48 children, 20 were excluded because of a 25(OH)D ≥30 ng/ml (n=13) or lack of bronchodilator response or airway responsiveness (n=7) at visit 1. Of the 28 remaining children, 4 were excluded because of non-adherence or poor asthma control during the run-in period.
728204|NCT01921517|Not all subjects enrolled (consented at screening visit) were randomized (randomized to intervention)|
730426|NCT01766102||
728212|NCT01921205|The study started to enroll patients in August 2013 and concluded in January 2017.|The Participant Flow refers to the Safety Set which included all randomized subjects who took at least 1 dose of study medication.
728213|NCT01921179||"Out of 76 enrolled participants: 12 were excluded after in person screening for not meeting inclusion criteria CAPS diagnosis of PTSD (n=11), or substance abuse (n=1); 8 participants left study after consent for scheduling, medical/family issues; and 10 left study during baseline assessment (were not randomized)
~46 participants were randomized"
728214|NCT01921166||
728215|NCT01921114||The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
728216|NCT01921101||
728217|NCT01920958|The study was conducted at 39 investigative sites in Germany from 30 September 2012 to 27 March 2014.|Collection of information of routine use of TachoSil® in participants who had lymph node surgery.
728218|NCT01920893|The study was conducted at 14 sites in 4 countries. A total of 60 participants were randomized between August 2013 and March 2014.|Randomization was stratified according to medical history of asthma (with/without asthma) and by nasal biopsy (biopsy performed,Yes/No). Assignment was done centrally using Interactive Voice/Web Response System in 1:1 ratio (dupilumab:placebo)after 4-week run-in period on Mometasone furoate nasal spray (MFNS) and confirmation of selection criteria.
728219|NCT01920854||
728220|NCT01920802||"There were a total of 69 consents in the study, 31 of which were randomized (started study medication). 24 subjects completed the study.
~The baseline characteristics reported were for the 24 subjects who completed the study."
728221|NCT01920711|4822 patients were randomized at 755 sites in 43 countries. 2419 participants were randomized into the LCZ696 treatment group and 2403 were randomized into the valsartan treatment group.|
728222|NCT01920594|This study was conducted across 10 centers in the United States and 2 centers in Canada from 31 October 2013 to 08 October 2014.|A total of 55 participants were randomized in the study and were included in All Subjects Population. Participants were stratified according to intervention type (surgical or endovascular repair, with the latter limited to 50% of the total study population).
728223|NCT01920568|The study consisted of three phases: Screening period , 49-week Double-blind treatment period and Follow-up period. The total participation time in the study was approximately 77 weeks.|A total of 487 participants (par.) were randomized in a 2:1 ratio to receive one of the two study treatments. A total of 485 participants received at least single dose of investigational products (IP).
728224|NCT01920555||The screening period served as a wash-out period for any prohibited medications that could be discontinued safely. Discontinuation of medications were discussed in consultation with the prescribing clinician.
728225|NCT01920477||Sixty-nine subjects were screened.
728226|NCT01920282||
728227|NCT01920178||
728228|NCT01919996|The sample size of 30 completed participants was specified by Food and Drug Administration (FDA) in the Post Marketing Commitment (PMC). Of the 30 pediatric participants planned for the study, 11 were screened and 8 participants received study treatment.|This was a prospective, non-comparative, open-label, single-arm study of azithromycin oral solution in 30 pediatric participants (aged 12 to 17 years) with pharyngitis/ tonsillitis who could be treated with azithromycin for their infection. The study design was intended to align with request from FDA to conduct the study.
728229|NCT01919970||Only 32 subjects were enrolled in this study (versus the N=40) indicated in the Protocol attached.
728230|NCT01919814||
728231|NCT01919801|The study was conducted at 59 sites in the United States, United Kingdom, Israel and Canada.|Overall 121 participants were randomized, of which 118 received the study medication, and 117 completed the study.
728232|NCT01919723||
728233|NCT01919697|Patients with CIC who completed the double-blind phase 2b (NCT01429987) study, or phase 3 (NCT01982240 or NCT0222471) studies or who screen-failed for the phase 3 studies due solely to pre-treatment diary compliance and met all of the inclusion criteria and none of the exclusion criteria enrolled into this open-label study.|A total of 2370 enrolled patients who had received at least one dose of the study drug constituted the Safety Population.
728234|NCT01919606||
728235|NCT01919450|Subjects with a low pretest likelihood for CAD based on gender, symptoms and recent (<90 days) normal-clinically-indicated TMET, exercise echocardiogram or exercise myocardial perfusion SPECT test were recruited for consent and participation.|
728236|NCT01919411||134 participants signed consent, but only 89 were randomized. The remainder failed screening.
728237|NCT01919398||Study completers were participants who were Dose-Limiting Toxicities (DLT) evaluable and discontinued the treatment due to any reason.
728238|NCT01919307||
728239|NCT01919229||20 patients were screened, of those 14 patients completed the Screening phase and were randomized. 6 patients discontinued during the Screening phase; 3 patients were considered screen failure and 3 patients discontinued due to patient's decision.
728240|NCT01919216|This study was conducted in the Adult and Late Life Depression Research Clinic at the New York State Psychiatric Institute (NYSPI) and approved by the NYSPI Institutional Review Board. Recruitment period started January 2010 and ended in June 2016.|11 enrolled participants were lost to follow up prior to randomization.
728241|NCT01919164||A total of 549 participants were randomized in this study.
728242|NCT01919112|All subjects were recruited from the inpatient neurology/stroke service at Beth Israel Deaconess Medical Center, Boston, MA. The first subject was recruited on 2/10/2014.|A total of 328 subjects were screened for the trial, of which 214 did not fulfill all trial criteria and 72 refused consent. A total of 42 subjects were eventually enrolled: 14 subjects in High-Dose tDCS, 13 in Low-Dose tDCS and 15 in Sham arms.
728243|NCT01918800||
728244|NCT01918774||
728245|NCT01918761||
728246|NCT01918371||323 patients were enrolled in the study and were divided into 2 groups based on their diagnosis: 166 patients with Retinal Vein Occlusion and 157 patients with Diabetic Macular Edema. 2 patients (1 in each group) were missing data and are not included in the analyses.
728247|NCT01918332||
728248|NCT01918306|This trial opened to accrual on 9/23/2013 and closed to accrual on 3/9/2016.|
728249|NCT01918189|Participant enrollment began July 1, 2014 and last data collection for primary outcome was October 31, 2018. Recruitment target of 58 participants was met. 59 participants enrolled in the study (i.e., signed informed consent) but 58 completed baseline measures and were included in outcomes analyses.|
728250|NCT01918085|The subjects were recruited in April 2012.All subjects were recruited to one site. Copenhagen Wound Healing Centre, Bispebjerg bakke 23, 2400 Copenhagen NV Denmark.|"Subjects must have an colostomy under 40 mm in Diameter. One subject was not randomised as the subject had a stoma with a diameter above 40 mm.
~Thus, 22 subjects were randomized."
728251|NCT01918072|Primary care providers (PCPs) delivering women's health care from June 2013 - September 2015 in VA healthcare systems that implemented the DWHP Support women's health clinical innovation, which is a technology-based program that combines interactive communication with women's health specialist and ongoing education.|STEPPED WEDGE CONTROLLED TRIAL INCLUSION CRITERIA: Designated Women's Health Providers (DWHPs) with one or more episodes of care for women patients during each period of the intervention. ELECTRONIC CONSULTATION SURVEY INCLUSION CRITERIA: DWHPs who submitted and received a response to a gynecology electronic consult during the study timeframe.
728252|NCT01918033||
728253|NCT01917812|We enrolled outpatients at an academic cardiovascular prevention center (Johns Hopkins Ciccarone Center) in Baltimore, Maryland, USA from January 17 to May 20, 2014.|
728254|NCT01917773|"All eligible patients referred for colonic manometry to the GI Motility Laboratory at Riley Hospital between Sep 2013 and June 2014.
~24 patients were assessed for eligibility to participate in the study in the hospital. 8 patients were excluded, as they did not meet inclusion criteria. 3 participant refused enrollment."|
728255|NCT01917747||
728256|NCT01917682|Patients that had a robotic-assisted PCI procedure.|
728257|NCT01917656|The trial was conducted at 39 sites in 7 countries as follows: Algeria: 7 sites; Israel: 4 sites; India: 5 sites; Lebanon: 2 sites; Malaysia: 7 sites; South Africa: 8 sites; United Arab Emirates: 6 sites|Subjects were randomised in a 1:1 manner to either switch to liraglutide 1.8 mg/day added on to metformin or to continue their pre-trial SU and metformin treatment.
728258|NCT01917526||
728259|NCT01917513||
728260|NCT01917344|A recruitment letter was sent to adults with PKU who were not enrolled in another clinical trial.|
728261|NCT01917318|A single participant was enrolled but did not complete the study.|
728262|NCT01917214||
728263|NCT01917188||
728264|NCT01917136||
728265|NCT01917006||Participants received a single treatment of either placebo or OnabotulinumtoxinA (Doses 1, 2, 3, 4, 5, 6), delivered bilaterally to the bulbospongiosus muscle in randomized-treatment period. Participants who completed 12 weeks of randomized period were eligible to receive second injection with OnabotulinumtoxinA Dose 2 in Open-label Period.
728266|NCT01916980||
728267|NCT01916967||
728268|NCT01916941||
728269|NCT01916928||
728270|NCT01916824|Participants were enrolled from the Emory Mood and Anxiety Disorders Program between August 2013 and December 2015.|A total of 55 individuals gave informed consent to participate in the study. Of these, 2 were screen failures, resulting in 53 who began the trial.
728271|NCT01916681||
728272|NCT01916655||
728273|NCT01916629||
728274|NCT01916590||
728275|NCT01916304|Participants took part in the study at 8 investigative sites in Belgium from 02 July 2013 (first patient screened) to 23 June 2014.|Participants with a diagnosis of Primary Hypothyroidism were switched from treatment with L-Thyroxine Christiaens® to treatment with new levothyroxine sodium 25-225 μg.
728276|NCT01916226|In anticipation of a 5% to 8% dropout rate, this study planned enrolment of 156 participants per treatment group in order to target 144 participants per treatment group, who would provide a full 2 weeks' worth of data.|A total of 978 participants were screened for this study. Of these, 73 were pre-screen failures and 223 were screening/run-in failures. A total of 682 participants were randomized (1:1:1:1 ratio) to receive study treatment.
728277|NCT01916109||
728278|NCT01915940||
728279|NCT01915914|Number of enrolled participants n=123 in Acute Phase and n=107 in Maintenance Phase (ITT Population).|Eligible participants (par.) received twice daily (BID) fluticasone propionate 0.05% (FP) cream up to 4 weeks (wk) (in Acute Phase), then par. received (1:1) either emollient BID plus FP cream once daily (OD) twice a wk, or emollient BID up to 20 wk (Maintenance Phase). Par. who did not relapse received emollient BID up to 12 wk (Follow-up Phase).
728280|NCT01915849||
728281|NCT01915823||
728282|NCT01915771||
728283|NCT01915732||
728284|NCT01915563||Slight number of patients were enrolled after reaching the planned sample due to information delay.
728285|NCT01915498|"Participants were enrolled at 21 sites in France and the United States. The study includes 3 parts: Phase 1 dose escalation, Phase 1 expansion, and Phase 2 expansion.
~The primary analysis for efficacy was conducted with a cut-off date of 1 September 2017; safety analyses for ongoing participants continued through 29 July 2019."|In Phase 1 Dose Escalation participants enrolled into sequential cohorts of increasing doses of enasidenib. After the recommended dose was determined enrollment into Phase 1 Expansion and Phase 2 began. Phase 1 Expansion enrolled participants into 4 non-randomized arms. Phase 2 enrolled participants with relapsed/refractory acute myeloid leukemia.
728286|NCT01915303||
728287|NCT01915173||
728288|NCT01915108||
728289|NCT01915095||
728290|NCT01914926|Recruitment of patients was from June 2009 to November 2010|No significant events
728291|NCT01914757||2505 participants signed informed consent, 2181 entered screening/run-in period, 1306 participants were randomised to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 1306 patients randomised, all (100.0%) received treatment with study drug.
728292|NCT01914679||
728293|NCT01914666||
728294|NCT01914510||
728336|NCT01911273|Only 3 participants were enrolled into this study as of termination date. One participant was assigned to receive PF-03446962 plus best supportive care (BSC) treatment and 2 participants were assigned to receive only BSC treatment.|
730532|NCT01757691||
730533|NCT01757678||
730534|NCT01757665||
728295|NCT01914393|participation in the preceding double-blind efficacy and safety studies (D1050301, NCT01911429,; D1050325, NCT01911442; or D1050326, NCT02046369) were eligible for enrollment in this study.|"Treatment groups in study D1050301: Placebo, Lurasidone 40 mg/day, Lurasidone 80 mg/day.
~Treatment groups in study D1050325: Placebo, Lurasidone 20 mg/day, Lurasidone 60 mg/day
~Treatment groups in study D1050326: Placebo, Lurasidone 20-80 mg/day"
728296|NCT01914159||
728297|NCT01914003||
728298|NCT01913795||
728299|NCT01913639||
728300|NCT01913600|56 XL subjects were enrolled from 9 study sites in the United States. The first subject was enrolled on July 26, 2013 and the last subject was enrolled on October 27, 2015.|
728301|NCT01913535||Only 8 participants were randomized because the study terminated early due to slow enrollment.
728302|NCT01913483||Participants who were randomized into the trial, who received at least one dose of study drug (Safety Population), and underwent the index peripheral endovascular interventions (PEI) procedure were included in the modified Intent-to-Treat (mITT) Population. This was the primary population for analyses of the primary and secondary endpoints.
728303|NCT01913470|Children were recruited from the patient population of Children's Healthcare of Atlanta and the Emory Children's Center Clinics.|Of the 16 individuals who signed the consent form, 4 were found to be ineligible to participate during screening process, resulting in 12 participants who began the study treatment.
728304|NCT01913405|Twelve study sites have enrolled participants in seven countries (US, Russia, UK, Bulgaria, Lithuania, Spain, Switzerland). There were 30 surgical enrollments in a total of 23 unique participants. Seven unique participants enrolled more than once, of whom five received study product for more than one surgical procedure.|A total of 23 participants provided informed consent and were screened for study participation. Of these, 22 unique participants (29 surgical enrollments) were exposed to study product. One participant discontinued prior to surgery and one subject discontinued after surgery.
728305|NCT01913353||
728306|NCT01913340||
728307|NCT01913327||One subject was immediately lost to followup prior to treatment randomization; a second subject dropped out due to non-serious side effects commonly-associated with study drug Risperidone.
728308|NCT01913314||
728309|NCT01913041|Dates of the recruitment period: From 2 Aug 2013 to 28 Nov 2013. Recruitment process: Random sample first and screening subjects according to the inclusion criteria and exclusion criteria, Assign ICF before enrollment.|
728310|NCT01912963|Participants enrolled from September 2013 through May 2016.|
728311|NCT01912872||
728312|NCT01912781|Subjects were recruited from 12 study centers located in the US.|Of the 112 enrolled, 2 subjects were exited as screen failures and 4 were discontinued prior to randomization. This reporting group includes all randomized subjects (106).
728313|NCT01912768|Subjects were recruited from 17 study centers located in the US.|Of the 362 enrolled, 10 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (352).
728314|NCT01912729||
728315|NCT01912716|Patients were recruited between July 2013 - March 2018, either from the ERCP (Endoscopic Retrograde Cholangiopancreatography) outpatient clinic or Peri-Operative Care Unit immediately prior to ERCP.|
728316|NCT01912612|3 cases randomized to placebo are not included in the analysis. See study description in protocol section for explanation. 3 patients on Arm 2 consented but withdrew prior to participation. 1 patient on Arm 1 withdrew permission to use her data.|
728317|NCT01912599||
728318|NCT01912495||
728319|NCT01912404|This was a placebo-controlled, double-blind, multicenter Phase 2 study in patients with alcoholic hepatitis who were contraindicated to receive corticosteroid therapy. The study consisted of a 7-day screening phase, a 28-day treatment phase, and a follow-up of 5 months. Total study duration for a patient was about 6 months.|Eligible patients were randomized in a 2:1 ratio to IDN-6556 25 mg or placebo administered twice daily for 28 days. During the treatment phase, the patients were assessed for safety and efficacy. Following the treatment phase, the patients were asked to return for follow-up visits at 1, 2, and 5 months after completion of study drug treatment.
728320|NCT01912352||
728321|NCT01912339||
728322|NCT01912287||
728323|NCT01912222|Participants took part in the study at 4 investigative sites in the United States from 27 August 2013 to 25 March 2015.|Participants with diagnosis of advanced solid tumors or hematologic malignancies having varying degrees of liver dysfunction enrolled in 1 of 3 treatment groups to receive ixazomib 4 mg (normal hepatic function), 2.3 mg (moderate impairment), 1.5 mg (severe impairment) on Day 1 (Part A, 15 day cycle) and on Days 1,8 and 15(Part B, 28 day cycle).
728324|NCT01911910||
728325|NCT01911845||
728326|NCT01911819||The enrolled patients had either unilateral or bilateral maxillary sinus requiring maxillary sinus graft. For patients with bilateral sinus, each maxillary sinus was randomly assigned different treatment groups.
728327|NCT01911793||
728328|NCT01911780|Of the 239 enrolled patients, 205 patients were entered in the run-in period and 132 were randomized. The remaining 107 patients were withdrawn from the trial before the randomization.|An eight-week randomised, double-blind study with active-control and parallel-group comparison in Japanese patients plus 52 week extension period.
728329|NCT01911689|Patients with AP admitted to our institution between August 2013 and March 2015 were recruited in this study.|Patients with iron deposition disorder or chroic blood system diseases should be excluded in this study, because these diseases can lead to the change of the T2* value.
728330|NCT01911546|Highly HLA Sensitized Patients with End Stage Renal Disease Receiving Deceased Donor or Living Donor kidney transplant were enrolled.|
728331|NCT01911442|Participants were recruited from 46 centers in the United States between August 2013 and October 2014|Participants were screened and washed out up to 21 days.
728332|NCT01911429||
728333|NCT01911403||
728334|NCT01911390|The study proposed to randomize approximately 40 subjects to complete 38.|A total of 41 subjects were screened and assented. Of the subjects assessed, 38 (93%) completed the trial with 3 (7%) withdrawn for noncompliance of required food consumption.
728335|NCT01911351||
728722|NCT01882803|This multicenter, multinational study enrolled subjects at 56 medical clinics across 12 countries.|
728337|NCT01911260|From original database of 2.519 children, enrolled in the first and second grades of four State-run public basic schools, we selected this study sample using height for age indicator (HAZ). Meetings were held at school with parents/guardians to explain the objective and procedures of the study in order to obtain a written consent.|From original database (n=2.519), we selected children with one and a half or more standard deviations below the mean height for age (HAZ) and gender of the reference population as Growth Deficit group. For the Normal Height group, HAZ was define as between -1 and +1 standard deviations from the mean height reference for age and sex (n=218).
728338|NCT01911221|Subjects were recruited from single study center in Germany.|All enrolled subjects were included in the trial.
728339|NCT01911169|Initially, subjects will be recruited from the MUSC/UMA clinics. Once interest is confirmed by the subject, study personnel completed a chart review to determine if basic inclusion/exclusion criteria is met. If pre-screen criteria were met, a screening visit was scheduled where the informed consent process will be completed by PI/Sub-I.|72 SLE patients were identified with a low 25(OH)D level. Of these, 56 failed further pre-screening based on disease activity, medication use, and known cardiovascular disease. Of the 16 who underwent a screening visit, 7 patients failed to meet criteria for enrollment. Nine patients met inclusion and exclusion criteria and were randomized.
728340|NCT01911065||
728341|NCT01910831|"The recruitment in this study is defined as follows:
~20 individual subjects were recruited to participate in the study.
~40 arms (1 left arm and 1 right arm) were analyzed for the results. The N for data analysis is 40."|
728342|NCT01910792|Patients will be recruited from the Center for Digestive Disorders or the Endocrinology, Diabetes, and Nutrition clinic during regularly scheduled outpatient visits. Subjects will also be recruited by placing IRB approved posters around BUMC and also placing an IRB approved email in the monthly resear|
728343|NCT01910688||
728344|NCT01910636|Participants were enrolled at a total of 20 study sites in Japan. The first participant was screened on 28 June 2013. The last study visit occurred on 09 June 2014.|188 participants were screened.
728345|NCT01910519|Patients were randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with or without AS03 adjuvant undergoing scheduled anterior cruciate ligament (ACL) surgery at the Hope Clinic - Emory Vaccine Center in Decatur, Georgia. Participants were enrolled between July 2013 and January 2014.|Of the 99 screened participants, 50 were enrolled and vaccinated. 2 participants withdrew from the study.
728346|NCT01910441||
728347|NCT01910402|The study consists of a Screening (14-28 days), Randomized (48 weeks) and Continuation (Cont.) Phase. Participants were said to have completed the study if they completed the Randomized phase and did not enter the Cont. Phase. Participants entering the Cont. Phase were said to have completed the study if they completed both phases of the study.|A total of 499 participants were randomized to receive dolutegravir (DTG)/ abacavir (ABC)/ lamivudine (3TC) fixed dose combination (FDC) or combination of atazanavir (ATV), Ritonavir (RTV) and FDC of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). A total of 495 participants received at least single dose of investigational products (IP).
728348|NCT01910389||
728349|NCT01910311||This was an open-label, fixed-sequence, 2-period study conducted in healthy participants to compare the single dose pharmacokinetics (PK) of baricitinib when given alone and when coadministered with rifampicin.
728350|NCT01910298||Out of the 131 enrolled participants, 127 received the study device and were included in the Safety population.
728351|NCT01910181||
728352|NCT01910129||
728353|NCT01910116||
728354|NCT01910064|436 subjects have been enrolled in 20 site in Japan: First subject included: May 16, 2013; last subject out: July 18, 2014|
728355|NCT01909973||
728356|NCT01909804|Participants were enrolled at study sites in Australia, New Zealand, and the United States. The first participant was screened on 17 June 2013. The last study visit occurred on 22 August 2014.|416 participants were screened.
728357|NCT01909791||
728358|NCT01909778||
728359|NCT01909713||
728360|NCT01909674||
728361|NCT01909570|The recruitment period was from January 2010 to December 2012. The location of the recruitment was University Hospital of Virgen de las Nieves in Granada.|A total of 194 women aged under 38 years were included in the study. Of these, 19 women were not randomised. The reasons were refusion to participate (n= 6), economic reasons (n = 2), participating in another study (n= 7) and not meeting criteria in further evaluation (n = 4).
728362|NCT01909466|An open-label, multiple dose, multiple-site trial of adult participants with schizophrenia for the first application of aripiprazole intramuscular (IM) depot 400 mg in the gluteal or deltoid muscle (1:1 ratio) followed by 4 monthly administrations to the deltoid muscle site in all participants.|Prior to the trial, the participants were stabilized for at least 14 days on their current oral antipsychotic medication prior to administration of the first aripiprazole IM depot.
728363|NCT01909336|This trial was conducted in the paediatric and emer- gency departments of the Hospital Regional Materno Infantil de Alta Especialidad in Nuevo Leon, Mexico between August 2013 and February 2014.|
728364|NCT01909180||
728365|NCT01909154||
728366|NCT01909141||
728367|NCT01909011||
728368|NCT01908972||
728369|NCT01908907|Ninety infants, less than or equal to one week of age, were recruited from the Sanford Health Boekelheide Neonatal Intensive Care Unit (NICU) between October 2012 and March 2014.|Preterm infants were between 24 and 33 6/7 weeks gestational age (GA) at birth. Adaptive enrollment was used to assure that infants <28 weeks GA were enrolled over the same time period as more commonly admitted preterm infants >28 weeks GA.
728370|NCT01908842||A total of 759 patients were enrolled. One patient who was randomized did not receive study drug, making the participant flow total 758.
728371|NCT01908829|This multicenter study was conducted at 281 centers globally. Randomization was stratified by sex, age group (< 65, ≥ 65 years), 4-week incontinence episode reduction group (< 50%, ≥ 50%) and geographic region.|Participants who met the screening inclusion/exclusion criteria went through a two week wash-out period and maintained a micturition diary during that the wash-out period. A total of 3815 participants were screened of which 2401 participants received solifenacin 5 mg run-in medication. A total of 2174 participants were randomized.
728723|NCT01882764||
728724|NCT01882725||
728372|NCT01908816|open-label, single arm study evaluating the safety of 0.5 mg ranibizumab. Patients received individualized ranibizumab intravitreal injections based on evidence of disease activity. The study was early terminated due to low recruitment that hampered to address the primary endpoint of the study|
728373|NCT01908803|Subjects were recruited from 12 study centers located in the US.|Of the 84 enrolled, 14 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (70).
728374|NCT01908751||91 patients were enrolled into the FAITH-2 pilot trial. Five of these enrolments were subsequently determined to be ineligible (not between the ages of 18-60 years, pathological fracture, no femoral neck fracture, did not provide informed consent (2 patients)). Therefore, 86 participants were included in the analysis.
728375|NCT01908699||273 participants randomized, 271 received treatment: 136 participants in the esuberaprost group and 135 in the placebo group. Two participants were excluded after randomization and never received treatment: 1 participant in the esuberaprost group was randomized by mistake and 1 participant in the placebo group was terminated per physician decision.
728376|NCT01908582||
728377|NCT01908530||Phase 4 did not go ahead
728378|NCT01908426|First patient enrolled: 26 September 2013, Data cut-off date: 01 June 2017|
728379|NCT01908205||
728380|NCT01908140|This study was conducted at 140 activated sites. A total of 121 sites randomised patients. The first patient was screened in Oct 2013 and the last patient visit was in Aug 2014.|Patients fulfilling inclusion/exclusion criteria at the time of the screening visit were entered into a run-in period of 14-21 days to assess disease stability.
728381|NCT01908127|September 2010- December 2010 paediatric clinic of dental school, Zahedan University of Medical Sciences|The parents of four the enrolled children declined the participation in the study
728382|NCT01908101||86 patients signed the study informed consent, but only 68 patients started the Eribulin treatment. Out of those 68 patients only 59 of them were evaluable.
728383|NCT01908062||
728384|NCT01907906||
728385|NCT01907854|The trial was conducted at 86 sites in 6 countries: Canada (14); Hungary (8); India (7); Israel (8); Spain (6); and United States (43).|Screening details: Subjects were adult males or females with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control with stable doses of sitagliptin and metformin for 90 days prior to screening.
728386|NCT01907828|Study enrollment was completed with a total of 61 participants randomized at 2 sites in Germany. The first and last participants were enrolled on May 12, 2014, and July 21, 2016, respectively.|
728387|NCT01907815|Recruitment Period: October 9, 2013 to January 25, 2016. All recruitment done within medical clinic settings at The University of Texas MD Anderson Cancer Center, The University of Chicago and The University of Maryland Greenebaum Cancer Center.|Study was terminated early, stopped due to lack of efficacy.
728388|NCT01907737||
728389|NCT01907516|"Subjects were participants in the Kapiolani Medical Center for Women and Children's (KMCWC) diabetes in pregnancy program known as A Sweeter Choice. Subjects were enrolled between February 4, 2009 and 3/11/2010."|
728390|NCT01907490||
728391|NCT01907334||
728392|NCT01907321|"Participants were only recruited for the EMST group. There was not a control arm. There were several reasons, including concern regarding recruitment which was painfully slow for this study.
~There is only 1 arm/group that completed the study."|See above statement. There was only the EMST group/arm recruited for this study.
728393|NCT01907269||
728394|NCT01907217||
728395|NCT01907113|"The trial was conducted in two trial centres as an open-label, parallel group design with one treatment period.
~The trial was performed in 40 male and female patients who were assigned to five treatment groups according to their creatinine clearance."|
728396|NCT01907100|Patients were initially treated with combination therapy consisting of nintedanib or placebo plus standard chemotherapy (pemetrexed/cisplatin), for a maximum of 6 cycles of 21 days duration. After completion of combination therapy, patients who had not progressed continued with nintedanib or placebo monotherapy.|"All participants were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the participants) met all implemented inclusion/exclusion criteria. Participants were not to be entered to trial if any of the specific entry criteria was violated.
~PD: Progressive Disease"
728397|NCT01907087||
728398|NCT01906866||
728399|NCT01906658||
728400|NCT01906515|Patients scheduled for neurosurgery|
728401|NCT01906476||
728402|NCT01906372|Subjects with active and refractory polymyositis or dermatomyositis were recruited at two clinical centers, The University of Pittsburgh and North Shore Long Island Jewish Center over a 16 month recruitment period. Two subjects did not reach the week 8 time point prior to withdrawing from the trial therefore additional subjects were enrolled.|If the enrolling physician planned to discontinue a specific immunosuppressive agent or glucocorticoid prior to study visit 1, a pre-defined washout period was required.
728403|NCT01906346||
728404|NCT01906008|Recruitment period: November 25, 2013 to May, 25 2017. Recruitment done at the University of Texas MD Anderson Cancer and LBJ.|Of the 122 participants enrolled 2 participant were excluded from the study before asssigment to groups.
728405|NCT01905956||
728406|NCT01905943|The study was conducted at 195 centers in 31 countries|A total of 1131 subjects were screened and 979 subjects were enrolled. Due to compliance issues a site in Romania was closed. Seven subjects were excluded from the analysis, because data integrity was impacted by the site's non-compliance. Hence, data analysis is reported for 972 enrolled subjects.
728407|NCT01905683||A total of 391 participants were screened, of which 370 participants were enrolled and treated. Of these, 124 participants were recruited from the lead-in study (62, 29 and 33 participants from the IncobotulinumtoxinA high, mid and low dose group respectively of study MRZ60201_3070_1 [2012-005054-30]) and 246 participants were newly recruited.
728408|NCT01905657|Participants who had non-small cell lung cancer (NSCLC) and whose tumors were assessed as being programmed cell death ligand 1 (PD-L1) positive were recruited for this study.|The data cut-off date for this results disclosure was 30 Sep 2015, at which time 159 participants were continuing on study treatment.
730535|NCT01757561||
748539|NCT00728949||Participants who had progressive disease (PD) were considered to complete the study
728409|NCT01905592|Previously treated, HER2 negative, germline BRCA mutation positive breast cancer patients were enrolled. The study was designed to randomize 306 patients, however enrollment was ended prematurely due to futility. Results are presented based on the primary analysis (data assessed from enrollment to end of follow-up, up to a maximum of 4 years).|Of the 215 patients enrolled, 9 patients enrolled based on a local Breast Cancer gene (BRCA) test results were later determined to be BRCA wild type by central testing. Therefore, only 206 of the 215 patients enrolled were included in the analysis, and were considered in centrally confirmed intent-to-treat (ITT) population.
728410|NCT01905553||
728411|NCT01905540||
728412|NCT01905423|This was a cross-sectional study. The final end points of the study are measures of community prevalence. Participant involvement in the study ended after each survey period. Participants were not followed across survey periods, but could be and were likely recruited into more than one survey period.|
728413|NCT01905267||
728414|NCT01905254||"Thirty-nine patients with AIH were eligible during the study period. Five patients were excluded: 4 patients due to ineffective or incomplete (<60% success rate) liver stiffness measurement, and 1 patient with a severe acute flare of AIH with markedly elevated liver enzymes."
728415|NCT01904864||
728416|NCT01904773|Subjects between the ages of 12 and 17 with Tourette's Disorder|There were 29 screening visits for 28 subjects, 1 subject was initially screen failed for exclusion 32 but rescreened and qualified and entered Part 1 of the study(104-4003 rescreened and qualified as 104-4004). Eligible subjects participated in Part 1 and then continued into a randomized 6 period crossover Part 2 of the study
728417|NCT01904760||
728418|NCT01904721||
728419|NCT01904604|Recruitment took place from September 2013 to July 2014 at the five listed university-based medical centers located in the United States.|
728420|NCT01904526||
728421|NCT01904448||
728422|NCT01904383|"An observational, non-randomised, non-interventional study (NIS) in participants diagnosed with type 2 diabetes mellitus (T2DM) who were treated as add-on therapy were included in the surveillance based on newly collected data under routine medical practice.
~Acronym used:
~Case report form (CRF)"|This non-randomized, post marketing surveillance (PMS) was a prospective study using a continuous investigation system. No specific criteria (e.g., demographics, baseline characteristics, concomitant drugs in use) were defined for participant enrolment. Participants were enrolled from July 2013 to September 2015.
728423|NCT01904279|A total of 52 participants were enrolled in the study. Study included a 21-day screening period.|
728424|NCT01904149||
728425|NCT01904071||
728426|NCT01904058|The study was conducted in 24 centers in the United Kingdom, Canada, and the United States between 19 August 2013 and 09 April 2015.|A total of 87 participants were screened out of which 66 participants were randomized into the study and the remaining 21 were screen failures.
728427|NCT01903993||A total of 527 participants were screened, of whom 287 participants were randomized. 143 participants to the docetaxel arm and 144 participants to the atezolizumab arm. Overall, 10 participants (8 in the docetaxel arm and 2 in the atezolizumab arm) did not receive any study treatment.
728428|NCT01903876|Recruitment took place between Feb 2010 - April 2010.|N=368 participants completed the eligibility screener and provided informed consent in the study, but failed to complete the baseline assessment. Because our randomization occurred following completion of baseline assessment, these participants were not randomized to groups and were not included.
728429|NCT01903863||
728430|NCT01903811||
728431|NCT01903798|4 participants were randomized. 3 in the standard of care (with Prednisolone) and 1 in mycophenolate + prednisolone arm. Out of 3 randomized to the SOC arm, 2 had a Lille score of <.45 and one had a Lille score of >.45. The participant who was randomized to mycophenolate + prednisolone had a Lille score of >.45.|
728432|NCT01903720||
728433|NCT01903564||
728434|NCT01903460||
728435|NCT01903434||
728436|NCT01903356|This is an observational study in patients with type 2 diabetes mellitus who had been administered with TrajentaDuo® Tablets. The Case Report Forms of 724 subjects investigated by 15 investigators at 14 hospitals were retrieved from November 15, 2012 up to September 13, 2017.|All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be enrolled in the study if any one of the specific entry criteria were violated.
728437|NCT01903265|A total of 205 patients were randomized to either TNX-102 SL or placebo; however, one patient was randomized in error (to the placebo group) and was not dispensed any study drug. Therefore, all disposition and safety tables are based on the safety population of 204 patients. Of these, 174 patients completed the study.|Screening for eligibility and washout of restricted medications.
728438|NCT01903252||
728439|NCT01903187||
728440|NCT01903148|Nephrology Units of 30 Spanish hospitals.|14 patients were excluded because they didn't fulfill the eligibility criteria
728441|NCT01903031|The first participant enrolled in December 2014 and final participant enrolled in September 2016. Enrollment took place at 21 US and non-US clinical research sites.|
728442|NCT01903005||A total of 668 patients who completed primary study OX219-006 (NCT01908842) or OX219-007 (NCT01848054) were enrolled. Three patients entered the study without taking any study medication and were excluded. A total of 665 patients were included in the data analyses.
728443|NCT01902953||
728444|NCT01902901||One person consented, but then immediately declined while doing the baseline survey, so she was never randomized.
728445|NCT01902888||
728446|NCT01902758||
728447|NCT01902628||
728448|NCT01902459|Subjects were recruited from July 2, 2013 through August 13, 2015 at a single center in the United States|
728449|NCT01902303|Recruitment occurred from 29Jul2013 through 09Sep2014. Subjects were recruited through three research clinics located in the US who had been trained in UVr application used to trigger recurrent oral Herpes Simplex Labialis.|Subjects who did not meet inclusion/exclusion or withdrew consent prior to enrollment were not enrolled in the study. Eligible subjects underwent minimum erythema dose (MED) UVr determination and if MED criteria was met were randomized. Those enrolled who did not develop prodrome following the UVr induced process were not treated.
728450|NCT01902173||27 participants were enrolled, however 1 participant on the Dabrafenib + GSK2141795 75 mg arm and 1 participant on the Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg were found to be ineligible. Furthermore, 3 participants on the Dabrafenib + GSK2141795 75 mg arm did not receive protocol treatment were not evaluable for any study endpoint.
728451|NCT01902134||
728452|NCT01902004||A total of 20 participants were excluded after being consented and prior to randomization. 5 were determined to be ineligible after completing the in-person screen visit in which they were consented. 15 withdrew consent before being randomized.
728453|NCT01901874||
728454|NCT01901848|A total of 69 participants consented before the screening session. Nineteen were excluded, and 50 were randomized. As a result, there were 69 who consented, but only 50 are included in the flow diagram for the trial.|
728455|NCT01901809||
728456|NCT01901653||
728457|NCT01901614||
728458|NCT01901588|Patient's familes were approached on the day of surgery and spoken to privately in the pre-op area. Fliers were placed at the phthalmalogist's offices so were generally aware of the study ahead of time.|
728459|NCT01901575||
728460|NCT01901432|This was a 2-part, multisite, open-label, non-randomized study to assess givinostat in patients with JAK2^V617F positive Polycythemia Vera. Part A assessed safety and was the dose escalation portion of study, while Part B assessed preliminary efficacy. Patients were enrolled in 5 countries (France, Germany, Italy, Poland and the United Kingdom).|Patients were enrolled into either Part A or Part B, transition from 1 part to the other was not allowed. 48 patients were enrolled into the study overall: 12 patients in Part A to determine the maximum tolerated dose (MTD) and 36 patients in Part B.
728461|NCT01901419|elective cardiac surgery|
728462|NCT01901393||
728463|NCT01901341|Due to difficulties with enrollment, this study was terminated early.|
728464|NCT01901328|Due to difficulties with enrollment, this study was terminated early.|
728465|NCT01901302|Due to difficulties with enrollment, this study was terminated early.|
728466|NCT01901289||
728467|NCT01901250|Three cohorts of kindergarten children were recruited from 5 elementary schools between 2007 and 2009. A total of 32 classrooms were randomized to xylitol (16 classrooms) and placebo (16 classrooms).|Out of 562 children recruited, a total of 37 children did not have the baseline dental examination (13 children were transferred out of school district and 24 children were absent from the baseline dental examination).
728468|NCT01901224||Randomization blind was never broken, so only overall study participant flow is available.
728469|NCT01901211||
728470|NCT01901185|"Patients with rheumatoid arthritis (RA) or psoriatic arthritis (psA) currently receiving treatment with etanercept were eligible to enrol in this study.
~First patient enrolled on 11 June 2013; last patient enrolled on 13 November 2013."|
728471|NCT01901146|This study was conducted at 123 sites in 20 countries from April 2013 to January 2017. The study consisted of a neoadjuvant treatment phase for 4 cycles, surgery, and adjuvant treatment for up to one year from the first day of study drug administration in the neoadjuvant phase.|Enrolled patients received run-in chemotherapy consisting of epirubicin and cyclophosphamide every 3 weeks for 4 cycles. After the run-in, participants with adequate cardiac function were randomized. Randomization was stratified by tumor stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.
728472|NCT01900899||In this study, participants from the study MENACWY-TT-039 (NCT01900899) and MENACWY-TT-048 EXT (NCT01900899) were followed up for persistence of immune response and safety for a maximum duration of 6 years.
728473|NCT01900730|Of the 3 participants started, only 1 completed with the other 2 withdrawing before treatment. The protocol was terminated early due.|All participants are listed in Group 1 due to this is a double blinded study and unable to determine which groups the participants were enrolled on.
728474|NCT01900704||
728475|NCT01900665||Participants were excluded after study enrollment,if PET imaging or CSF results did not show evidence of brain amyloid pathology,a screening MRI with results >4 ARIA-H(amyloid-related imaging abnormality-hemorrhage/hemosiderin deposition) or presence of ARIA-E(amyloid-related imaging abnormality-edema/effusions) and abnormal lab results were found.
728476|NCT01900652||
728477|NCT01900626|2 participants were enrolled in the study. However,this study was being closed due to difficulty with enrollment and changes to standard of care. No data was analysed for outcome measures.|
728478|NCT01900561||
728479|NCT01900444|Study participants were enrolled from 11 July 2013 to 27 September 2013 at 8 clinic centers in South Korea.|A total of 119 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
728480|NCT01900431|The study was conducted at 18 centers in 6 countries. A total of 82 participants were screened between 30 October 2013 and 17 March 2015 of whom 58 participants were randomized and 24 were screen failures. Screen failures were mainly due to exclusion criteria met.|Participants were randomized in 2:1 ratio (Sarilumab:Placebo) and treated for 16 weeks during principal treatment period (Part A), 30 responders treated up to Week 50 with same dose during extension treatment period (Part B) while 10 non-responders and 11 participants (not completed Part A) treated with open label treatment up to Week 50 (Part C).
728481|NCT01900392||
728482|NCT01900314|Subjects were recruited between October 2013 and October 2015. Subjects exhibited moderate levels of treatment resistance|44 patients were screened in person and 40 consented for the study.
728483|NCT01900249||
728484|NCT01900067||
728485|NCT01900054||
728486|NCT01899911||
728487|NCT01899768||All eligible participants (par.) received treatment of either GSK2339345 or placebo at each visit in Parts A (Visits 1-3), B (Visits 4 and 5) and Part C (Visits 6 and 7).
728488|NCT01899742|Eligible participants (par) completed a 4-week open label tiotropium run-in phase, and were randomized to blinded study medication for 12 weeks. Supplemental albuterol/salbutamol was provided to all par, to be used on an as-needed basis during the run-in phase and up to Day 85.|A total of 739 par were enrolled; 496 par randomized and 494 par were included in the Intent-to-Treat (ITT) Population (Pop), comprised of all par randomized to treatment (trt) who received at least 1 dose of randomized study medication in the trt period.
728489|NCT01899729||
728490|NCT01899677||
728491|NCT01899261||
728492|NCT01899144|Of the 102 patients screened, 61 patients at 14 centers in the US met entry criteria and were considered to be eligible for enrollment into the study. 41 patients were not enrolled: 33 were excluded due to inclusion criteria, 1 patient withdrew consent, 3 patients were lost to follow-up before the baseline visit, and 4 patients for other reasons.|Participants were randomized in a 1:1:1:1:1:1:1:1:1:1 fashion into 10 treatment sequences with 6 participants in 9 of the sequences and 7 participants in the remaining sequence.
728493|NCT01899053|Participants took part in the study at 5 investigative sites in Spain, United Kingdom and United States from 28 June 2013 to 30 April 2018.|Participants with a diagnosis of advanced nonhematologic malignancies were enrolled. A total of 101 participants were enrolled, out of which 81 entered the escalation phase, and 20 entered the expansion phase.
728494|NCT01898884|This is a multicenter study conducted between 13 August 2013 and 18 June 2015.|A total of 46 participants were enrolled to the study, of which 32 were randomly assigned to single-dose group and 24 were randomly assigned to multiple-dose group. Participants who received investigational product in a single-dose group and completed the post-treatment safety assessment were allowed to enrol in a multiple-dose group.
728495|NCT01898806||Since the PI left the institution, the only data available at this time is information on the population enrolled that was provided to the IRB. Data was not provided to the IRB per arm, but rather, for as a collective whole
728496|NCT01898611||
728497|NCT01898598||
728498|NCT01898442|Between September 2013 and June 2014.|There were a total of 129 STEMI activations; of these, 52 patients provided their written informed consent to participate in the study and were randomized.
728499|NCT01898429|Recruitment began in Jan 2012. Participants were enrolled from July 2013 through January 2016. Patients were primarily recruited by clinicaltrials.gov and through information provided to providers.|All participants entered the left unilateral stimulation phase first; all then transitioned to the right side. This decision was made by the unblinded programmer. Patients and raters were still blinded to treatment allocation.
728500|NCT01898403||
728501|NCT01898299||
728502|NCT01898286|Patients diagnosed with Type 1 diabetes mellitus up to six months before randomization to Study 1001 (NCT01103284), from medical sites in the EU, US, Russia, and Israel|
728503|NCT01898208|Subjects were recruited at the Mayo Clinic in Rochester, Minnesota from August 2013 to March 2014.|
728504|NCT01898195||
728505|NCT01898130|The study opened for accrual on October 11, 2013 with an accrual goal of up to 27 patients. The first patient started treatment November 27, 2013. The study was designed to enroll 9 patients initially and do an interim efficacy assessment. The study was closed permanently on April 24, 2017 with 27 patients enrolled.|
728506|NCT01898091||
728507|NCT01898078|Participants took part in the study at 3 investigative sites in the United States from 16 July 2013 to 24 January 2017. Data cut-off for the primary analysis was 05 March 2014.|Participants with a diagnosis of advanced solid tumors or lymphomas were enrolled to crossover fashion to receive alisertib 50 mg enteric-coated tablet (ECT), orally in fasted or fed state in Cycles 1 and 2.
728508|NCT01898013||
728509|NCT01897896||
728510|NCT01897792||
728511|NCT01897766||It is a retrospective study. Data was collected for participants from July 2005 - February 2017(approximately over 11 years 6 months).
728512|NCT01897727|Consecutive adult patients with symptoms of OSA and resistant HTN between 2009 to 2012, were enrolled from the Hypertension Clinic at the University of Alabama at Birmingham.|"There was no wash out; ongoing use of a potassium sparing diuretic, including spironolactone, eplerenone, triamterene, or amiloride precluded study participation.
~A total of 17 participants (out of the 41 who were enrolled) were randomized into the two groups. 24 participants met exclusion criteria before randomization."
728513|NCT01897714|This was an open-label, Phase I/IIa study conducted at 7 study centers in 5 countries in patients with relapsed and/or relapsed-refractory Multiple Myeloma (MM). Overall, 75 patients (23 during Phase I and 52 additional patients during Phase II) were enrolled. The study results are presented until the end of trial (EOT) date of 29 October 2019.|The study was conducted in 2 parts: Phase I (dose escalation) and Phase II (maximum tolerated dose [MTD]). During Phase I, the standard 3 + 3 design was followed with 3 to 6 patients tested at each dose level, depending on the dose limiting toxicity (DLT) observed. During Phase II, patients were treated at the MTD determined in Phase I.
728514|NCT01897532|Prior to initiation of any trial-related procedure, all patients were informed about the trial verbally and in writing by the investigator. The patients signed and dated the informed consent before any study related procedures.|Patients with documented diagnosis of Type 2 Diabetes Mellitus (T2DM) at high risk of cardiovascular (CV) events and who met all the inclusion criteria and did not meet any of the exclusion criteria could be enrolled in the trial.
728515|NCT01897493||
728516|NCT01897402|Participants recruited and were enrolled at three sites in Maryland between October 21, 2013 and May 22, 2014. The sites screened 1086 subjects with 559 screen failures. The majority, 390 subjects (69.8 %), failed due to inclusion or exclusion criteria (IC/EC). The most common failure criterion was Laboratory abnormalities (150 subjects, 26.8 %).|Other common reasons for screen failure were inability to re-schedule within enrollment window after trial start was delayed (101 subjects, 18.1 % of screen failures) and lost to follow up 65 subjects (11.6%). These two reasons account for 166 (29.7%) subjects who met IC/EC, but did not enter the trial.
728517|NCT01897285||
728518|NCT01897233||The study was conducted in 2 parts - Part A and Part B. Part A consisted of 2 cohorts, in which participants aged 6 to 8 years were enrolled in Cohort 1 and participants aged 9 to 11 years were enrolled in Cohort 2. Part B consisted of a single cohort. Participants from Part A may have also participated in Part B of the study.
728519|NCT01897077||
728520|NCT01897025||42 chronic stroke subjects underwent screening, of whom 23 were excluded due to not meeting the inclusion criteria (n=5), not meeting the BCI performance criteria (n=10), or declining participation (n=8). A total of 19 subjects were recruited and randomly allocated to the real-tDCS group (n=10) or the sham-tDCS group (n=9).
728521|NCT01896986||
728522|NCT01896934||Participants taking ineffective antidepressant medications underwent a washout period. 10 recruited individuals were withdrawn after screening for a) concomitant medications (N=2), b) depression not severe (N=4), c) MRI contraindications (N=4)
728523|NCT01896921||
728524|NCT01896895||A total of 68 participants were screened, 61 were enrolled and treated of which 55 completed the double-blind main period (MP). 39 participants from the double-blind MP entered the Open label Extension (OLEX) period and completed the study.
728525|NCT01896869||
728526|NCT01896856||
728527|NCT01896726||This was an open-label, fixed-sequence, 2-period study. Each participant received a single dose of Microgynon on Day 1 of Treatment Period 1. During Treatment Period 2, participants received baricitinib on Days 23 through 30 with coadministration of Microgynon on Day 29.
728528|NCT01896700|24 people with MS and imbalance from the MS clinics in the Portland, OR metropolitan area were enrolled into this study between September 2013 and March 2016 .|
728529|NCT01896687||
728530|NCT01896557||
728531|NCT01896544||
728532|NCT01896297||
728533|NCT01896232|This study was conducted at 164 centers in Austria, Belgium, Canada, the Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, New Zealand, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey, and the United States. Participants were enrolled from 13 August 2013 to 16 May 2014.|Eligible participants were stratified by screening serum parathyroid hormone (PTH) level (< 900 or ≥ 900 pg/mL) and region (North America or non-North America) and were randomized 1:1 to receive etelcalcetide intravenously (IV) plus oral placebo or oral cinacalcet plus placebo IV.
728534|NCT01896206||
728535|NCT01896193|Participants were enrolled at a total of 16 study sites in Russia. The first participant was screened on 06 June 2013. The last study visit occurred on 27 July 2014.|139 participants were screened.
728536|NCT01896128||
728537|NCT01896115|All subjects in Phase 1 received all Phase 1 treatments (Short PW, Conventional PW, Dorsal Steering, and Ventral Steering), so treatments are described as milestones below. The remaining 24 patients were assessed in Phase 2 for secondary/exploratory endpoints comparing single contact stimulation vs. current steering.|Interim analysis showed 16 patients to be a sufficient sample size for primary endpoints.
728538|NCT01896050||
728539|NCT01895972||
728540|NCT01895959||
728541|NCT01895946|There were 2 parts to this study: Part A (tablet formulation assessment) followed by Part B (food effect assessment). Part A: first patient enrolled on 18/12/2013 and last patient completed on 16/12/2014. Part B: first patient enrolled on 10/09/2014 and last patient completed on 22/07/2015. Part A was conducted at 3 sites and Part B at 2 sites.|Note, Part A involved a cross over between tablet and capsule formulations A total of 33 patients were enrolled. 30 of these patients passed screening assessments and were dosed
728542|NCT01895777|A multi-centre, open-label, randomised, parallel-group, active-controlled, non-inferiority trial of dabigatran etexilate (DE) versus standard of care (SoC) in children from birth to less than 18 years of age.|"All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
~Subjects were not to be allocated to a treatment group if any of the entry criteria were violated."
728543|NCT01895647||
728544|NCT01895634||
728545|NCT01895608||
728546|NCT01895543|The trial enrolled patients from two lead-in, double-blind efficacy trials (000079 and 000080).|
728547|NCT01895452|Subjects who successfully completed the treatment period in Study ALK9072-003EXT and continued to meet eligibility criteria were eligible to enroll in this extension study.|
728548|NCT01895361|Approx. 174 patients were planned. A total of 198 patients were randomized. 192 patients received at least 1 dose of study drug & were analyzed for safety; 198 patients were analyzed for efficacy, 125 patients contributed data to the analysis of SelG1 PK data, & 176 patients contributed data to the analysis of PD data (% P-selectin inhibition).|The study included a Screening Phase, Treatment Phase, and Follow-up Evaluation Phase. During the Screening Phase, potential study participants were to be fully screened for both inclusion and exclusion criteria before and undergo clinical and laboratory evaluations within 30 days prior to randomization into the study.
728549|NCT01895335|The study was conducted at 169 centers in 14 countries. A total of 1102 participants were screened between June 14, 2013 and November 27, 2014 of whom 101 were screen failures. Screen failures were mainly due to exclusion criteria met.|A total of 1001 participants were included and 1000 participants were treated in the study. Dose of Teriflunomide tablet was given according to local labelling 14 mg or 7 mg (Teriflunomide 14 mg was the recommended dosage worldwide, except in the US [where both 7 mg and 14 mg were available]).
728550|NCT01895322||
728551|NCT01895309||
728552|NCT01895270||96 consented to screen under a separate screening protocol. Of these, 28 signed consent for this clinical trial. Of 28 signing informed consent, 3 signed informed consent but did not start the trial: one was assigned to ISR and one to PLA. One was lost to follow up before they could be cleared for study entry
728553|NCT01895127||
728554|NCT01895101||
728555|NCT01895088||
728556|NCT01895062||
728557|NCT01895036||
728558|NCT01894984||
728559|NCT01894919|Subjects were recruited from 9 study sites in Hungary and 8 study sites in Spain.|All enrolled subjects were included in the study.
728560|NCT01894906|19 patients were screened and 12 total patients were enrolled. Each patient participated in each of the 6 treatment periods.|
728561|NCT01894841|Participants were recruited from the Providence VA Medical center psychiatric inpatient unit|One hundred and seven participants completed baseline assessments and were found to be eligible for the study. Two participants were lost prior to randomization since they could not be contacted by research staff.
728562|NCT01894776|The Clinical Investigation Unit (CIU) at the OHRI has a database of healthy volunteers interested in participating in clinical studies who were contacted and recruited by phone or email. The first patient was recruited on 06 Sept 2013 and the last follow-up visit was on 23 Dec 2013.|
728563|NCT01894672|Protocol Open to Accrual 07/03/2013 Protocol Closed to Accrual 03/24/2015 Primary Completion Date 03/17/2016 Recruitment Location is the medical clinic|
728564|NCT01894620||
728565|NCT01894607|Recruitment Period: October 07, 2013 to May 23, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
730567|NCT01755455||
728566|NCT01894581|39 regularly menstruating obese and normal-weight women were recruited from the community through campus-wide advertisements.|Potential participants were screened out if they had polycystic ovary syndrome, allergies to seafood, used medications known to affect reproductive hormones, used exogenous sex steroids within the last 3 months, exercised vigorously more than 4 hours weekly, or were attempting pregnancy. Eligible subjects then had a baseline physical examination.
728567|NCT01894568||
728568|NCT01894555||
728569|NCT01894516|Participants were enrolled at study sites in Latin America, Europe, United States, and New Zealand. The first participant was screened on 08 October 2013. The last study visit occurred on 29 May 2015.|A total of 625 participants were screened of which 287 participants were randomized into the study and only 283 participants were treated.
728570|NCT01894503|A prospective, single-center open label study treating adult patients with recurrent polyposis after bilateral total ethmoidectomy. Study period 9 July 2013 to 17 July 2013|A total of six patients were enrolled (consented). One patient did not have the required grade 2 polyposis on at least one ethmoid side and was excluded. The remaining five patients meet all eligibility criteria and underwent an in-office bilateral placement of two S8 Sinus Implants. All five patients completed follow-up through the Day 90 visit.
728571|NCT01894477||
728572|NCT01894256|First patient enrolled: 20 Nov 2013; last completed Part A: 27 Mar 2015. Patients were enrolled at 13 sites in 5 countries. Part A assessed PK of olaparib in patients with mild/moderate renal impairment vs normal renal function; Part B provided additional safety data. Data are presented for Part A and Part B.|56 patients were enrolled into the study, of which 12 did not fulfill the eligibility criteria. Consequently, 44 patients were assigned to treatment and received at least one dose of olaparib in Part A. Forty-three of these 44 patients were assigned treatment and received at least one dose of olaparib in Part B.
728573|NCT01894243|The first patient was enrolled on 13 March 2014 and the last patient was enrolled on 23 January 2015. Patients were enrolled at 8 centers in 3 countries. Of the 31 patients enrolled, 24 were assigned to treatment.|Approximately 30 patients were planned to be enrolled with at least 24 evaluable patients required to complete Part A (8 patients with normal hepatic function, 8 with mild hepatic impairment and 8 with moderate hepatic impairment). An evaluable patient is defined as a patient having full PK sampling to 96 hours post-dose of olaparib
728574|NCT01894230|Eight participants that signed a consent either withdrew consent, were lost-to follow up, or were screen-failures and thus were not randomized.|
728575|NCT01894178||
728576|NCT01894152|A total of 2140 patients were registered from 35 centres in China. First patients was enrolled on July 12, 2013 & enrollment was completed on Sep11, 2014 through the Interactive Voice Response System (IVRS) excluding those without consent and those without stent implants & duplicate entries. Thus the analysis population includes 2002 participants .|Of the 2140 registered subjects,138 subjects withdrew from the study due to incomplete consent forms, no implanted study stents and repeated entry in voice interactive selection system. Among the final analysis population (n=2002), a total of 151 subjects failed to complete the follow-up period.
728577|NCT01894100|Beginning 6/14/2013, 510 participants from the Johnston County Osteoarthritis Project cohort were identified as potential participants for this study based on a history of knee or hip symptoms and a body mass index of <35 kg/m2 at last cohort study visit.|Of the 510 participants that research assistants attempted to contact via telephone, 46 participants were eligible and agreed to participate in the study (enrolled from 8/7/2013 through 4/30/2014). 16 were excluded from assignment to an intervention group because they did not have a leg length inequality >=1/8 inch on standing radiograph.
728578|NCT01894087||
728579|NCT01894022|This was an open label, long-term extension study to the double-blind, placebo-controlled study AMB115811 (NCT01884675). Only those participants (par.) in study AMB115811 were eligible for enrollment in this study. The planned duration was a minimum of 18 months, but the study was terminated due to futility of enrollment in study AMB115811.|Out of the 33 participants randomized (16 participants in the Placebo arm and 17 in the Ambrisentan arm) in study AMB115811, a total of 19 participants were enrolled in this extension study.
728580|NCT01893983|"(1) CBOC providers will refer veterans; (2) VA administrative data will be used to identify veterans; (3) veteran self-referral; (4) snowball sampling"|Baseline assessment was used to determine mental health eligibility. Those who did not score high enough on mental health symptoms AND/OR had recently had recently had a mental health visit and/or a schedule mental health visit were excluded.
728581|NCT01893905||
728582|NCT01893879||
728583|NCT01893827||
728584|NCT01893801||
728585|NCT01893632||
728586|NCT01893567||
728587|NCT01893411||The Safety Evaluation Set (SES) is the subset of all participants treated with study medication at least once.
728588|NCT01893372|Recruitment Details: October 2013 to January 2016|
728589|NCT01893359||
728590|NCT01893346|First patient enrolled: 26 July 2013 Last patient last visit: 09 October 2014|Eligibility was determined by investigator, prior to enrollment. Patients were selected on the basis of the age requirements for the appropriate cohort and after obtaining written informed consent from the parent or legal guardian and assent from patients (as appropriate). Screening assessments were completed prior to study drug administration.
728591|NCT01893281||
728592|NCT01893203||
728593|NCT01892865|Calendar days during which vascular surgery operations were performed were randomly scheduled using either the Historical Means or the Predictive Modeling System methodologies. Please, note that unit of randomization was operative days, not patients|Operative days that were on holidays, or when staff surgeons were out of town were excluded. Similarly, did not schedule any cases during the re-calibration of the predictive models
728594|NCT01892722||This study is divided into a core phase and extension phase. In the core phase, patients were randomized to Fingolimod or Interferon beta-1a in a 1:1 ratio. The core phase disposition is reported for interim results disclosure. Upon completion of the extension phase, the extension disposition will be reported.
728595|NCT01892709||
728596|NCT01892657|Subjects were screened at a single US center.|
728597|NCT01892540||
729027|NCT01860534|July 2011 to september 2012. At the University of Texas medical Branch.|60 neonates were excluded prior to randomization since they did not meet inclusion criteria, refused to participate or other reasons.
728598|NCT01892436|The extension FAS (N=457) comprised all patients enrolled in the extension with at least 1 post baseline efficacy assessment during the extension study. 3 patients signed the ICF but had no efficacy assessments during the extension study and were not included in extension FAS.|Of the 457 patients in the extension FAS, 380 (83.2%) completed 260 weeks of treatment (84.4% in the secukinumab 10 mg/kg-75 mg group, 82.0% in the secukinumab 10 mg/kg-150 mg group, 85.1% in the placebo-secukinumab 75 mg group and 81.3% in the placebo-secukinumab 150 mg group)
728599|NCT01892345||Main inclusion criteria were: participants aged ≥ 18 years old with NMO/NMOSD, AQP4 antibody-positive, historical relapse of at least 2 in last 12 months or 3 in last 24 months with at least 1 in 12 months prior to screening, Expanded Disability Status Scale score ≤ 7. If receiving immunosuppressive therapies, must be on a stable maintenance dose.
728600|NCT01892306|37 were invited to consent. 34 consented to be screened for inclusion. 5 did not meet study inclusion criteria thus were not randomized (1 not on a stabilized medication; 1 did not meet criteria for anxiety disorder; 2 were currently substance dependent; 1 reported psychosis). 29 were randomized to TAU or TAU plus 18 sessions of CBT (UP+TAU).|Participants were excluded from the trial before assignment to study arms based on exclusion criteria related to diagnosis and unstable medication regime.
728601|NCT01892293||
728602|NCT01892267|Patients were enrolled between 7/1/13 and 4/14/14 in an academic tertiary center|
728603|NCT01892189|Participants took part in the study at 1 investigative site in the United States from 27 June 2013 to 28 August 2014.|Healthy male participants were enrolled in this 3 period study and randomized in 1 of 9 administration sequences to receive TAK-063 3 mg, TAK-063 10 mg, TAK-063 30 mg and TAK-063 matching placebo. Due to predicted exposures being higher than likely clinically relevant, the dose of 300 mg was removed and replaced by 10 mg in protocol amendment 3.
728604|NCT01892163||
728605|NCT01892020|This trial was conducted in 14 sites in one country (China).|There were no significant events following enrolment of subjects, and prior to randomization.
728606|NCT01892007||
728607|NCT01891994||
728608|NCT01891968|Recruitment Period: 8/2013to 01/2017|Of the 15 participants registered, all were treated with the study medication.
728609|NCT01891890|Participants were recruited from 14 pediatric practices in the United States of America between August 2013 and October 2015.|In total, 78 individuals consented to participate in the trial. Of these 6 were found to be ineligible or declined to participate prior to receiving the intervention, resulting in 72 participants who received the study intervention.
728610|NCT01891864||
728611|NCT01891734||
728612|NCT01891721||6 participants were excluded from the study before being randomized to groups: 4 for not meeting inclusion criteria and 2 for not wanting to participate.
728613|NCT01891669||
728614|NCT01891357||"Patients should only have been registered for the study, if final results of screening evaluations were available and all inclusion/exclusion criteria met. This was not true for 3 patients.
~Patients should not have been registered due to distant metastasis. These patients were classified as screening failures and withdrawn from the study."
728615|NCT01891331||
728616|NCT01891305||
728617|NCT01890967||
728618|NCT01890954||
728619|NCT01890915||
728620|NCT01890785||
728621|NCT01890759|Study participants were enrolled from 25 June 2013 to 05 November 2013 (Russian Federation) and 24 March 2015 to 17 November 2015 (India) at 4 clinic sites in Russia and 4 clinic sites in India.|A total of 300 participants (100 in Russia and 200 in India) were enrolled. Of the 100 Russians, 2 did not receive the second vaccination. Of the 200 Indians, 1 did not receive the first vaccination and 8 did not receive the second vaccination.
728622|NCT01890746|Participants (Par.) diagnosed with Acute Myelogenous Leukemia (AML) of any subtype (except acute promyelocytic [M3] or acute megakaryocytic leukaemia [M7]) were eligible for the study.|Sufficient number of participants were screened and 148 participants were randomized and entered in to the study. Participants were stratified by antecedent malignant hematologic disorder (yes versus no) and age (18-60 years versus >60 years), before they were randomized to receive study treatments.
728623|NCT01890707|Subjects will be recruited up to 14 days prior to surgery, by either the anesthesiology or the gynecology investigators. A preoperative anesthetic assessment will be completed. Once consent for the study has been obtained subjects will be randomly allocated into 2 groups, using a computer generated table of random numbers.|
728624|NCT01890694||
728625|NCT01890642||
728626|NCT01890577||
728627|NCT01890512|INFINITE MRI study started subject enrollment on 17 June 2013.Las subject was enrolled on 2 October 2013 and last subject follow up concluded on 17 January 2014. Study database was closed on 28 February 2014.|
728628|NCT01890473||356 participants enrolled and 224 randomized. 132 not randomized and reasons for non-randomization: 106 no longer met study criteria, 15 other, 9 withdrew consent, and 2 lost to follow-up.
728629|NCT01890434|The study was conducted at 24 centers across 4 countries, between 26 August 2013 (first patient first visit) and 06 August 2016 (last patient last visit).|Overall, 504 participants signed the informed consent, of which 14 did not finish their baseline visit (7 screening failures, 7 dropouts). A total of 490 participants entered the diagnostic imaging phase, of them 478 participants were treated and entered the follow-up phase.
728630|NCT01890421|The study was conducted at 23 study centers in 7 countries (Germany, South Korea, United Kingdom, France, United States, New Zealand and Switzerland), between 19 July 2013 (first subject first visit) and 10 April 2015 (last subject last visit).|Overall, 456 participants signed the informed consent, of them 19 did not finish their baseline visit (6 screening failure, 13 dropped out), 1 discontinued the study due to an adverse event (AE). A total of 436 participants entered the diagnostic imaging phase, of them 426 were treated with gadobutrol and entered the follow-up phase.
728631|NCT01890343||34 subjects were enrolled in the trial but 6 subjects did not receive florbetapir and were not included in the Overall Study period.
728632|NCT01890265|Adult participants with a history of idiopathic pulmonary fibrosis (IPF) ≤5 years duration and a forced vital capacity (FVC) predicted value ≥55% at screening were randomized to receive pamrevlumab or placebo.|This Phase 2 study was conducted at 44 study centers in 7 countries from July 2013 to November 2017.
728633|NCT01890226|311 participants were eligible and consented to participate.|
728634|NCT01890148|"Thirteen patients were screened; 8 patients were screening failures, 5 patients were enrolled in the study and received treatment with AZD5069.
~First patient enrolled: 11 March 2014. Last patient completed: 18 August 2014."|
728635|NCT01890122|Participants took part in the study at 59 investigative sites in China, Malaysia, South Korea and Taiwan from 26 August 2013 to 05 October 2015.|Participants with a diagnosis of type 2 diabetes mellitus were enrolled equally in 1 of 4 treatment groups, twice a day placebo, alogliptin 12.5 mg, metformin hydrochloride (HCl) 500 mg, or alogliptin 12.5 mg and metformin HCl 500 mg fixed dose combination (FDC).
728636|NCT01890109|"This study was conducted at 6 centers in the United States from 13 May 2013 to 11 March 2014.
~Screening included completion of a 7-day diary to record hot flashes."|Participants meeting the eligibility criteria were randomized in a 1:1 ratio to erenumab or placebo. Participants were stratified based on the average number of hot flashes per 24 hours during the screening period (≤ 11.5 or > 11.5).
728637|NCT01890031||
728638|NCT01889862|Only subjects who completed a previous pegvaliase study (i.e. PAL-003, 165-205, or 165-301) were eligible for participation in 165-302.|Pt 1 (3-13wk) was an open-label period to establish eligibility for participation in Pt 2. Eligible subjects (achieve and maintain randomized dose of 20 or 40mg/day and ≥20% reduction in blood Phe) enrolled into Part 2 (8wk). Subjects completing Pt 2 were eligible for Pt 3 (6wk). Part 4 is ongoing. Pt 2 results are currently shown (n=95).
728639|NCT01889797||
728640|NCT01889667||
728641|NCT01889602||
728642|NCT01889563||
728643|NCT01889420||
728644|NCT01889355||
728645|NCT01889251|Subjects were recruited from 40 study centers located in Japan.|Of the 251 enrolled, 79 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (172).
728646|NCT01889238||Data reported based on primary analysis date (01 March 2015)
728647|NCT01889069|The study was conducted at 37 investigational centers in Italy.|Total overall participants enrolled in the study was 159, however for the subject disposition and baseline characteristics the enrolled was 158 as one participant discontinued the study prior to treatment.
728648|NCT01888965||
728649|NCT01888952||
728650|NCT01888900||
728651|NCT01888874|Participants were enrolled at study sites in Europe, South America, North America, Australia, and New Zealand. The first participant was screened on 17 July 2013. The last study visit occurred on 14 May 2015.|A total of 1255 participants were screened of which 599 participants were randomized into the study and only 594 participants were treated.
728652|NCT01888640||
728653|NCT01888432|In all, 284 patients were randomized after transplantation to EVR+Reduced TAC group and TAC Control group. Two patients were not eligible and randomized in IRT by mistake and to whom no study medication was given, and so did not have their data included.|A total of 494 patients were screened. Of these, 448 patients received a liver transplant and entered the run-in period.
728654|NCT01888367||
728655|NCT01888003||
728656|NCT01887990||
728657|NCT01887912|Study participants were enrolled in the study from 30 July 2013 to 17 November 2017.|A total of 9302 participants were enrolled and randomized in the study.
728658|NCT01887717|Participant enrollment started on February 27, 2014 and was terminated prematurely on March 31, 2016 due to slow recruitment, after randomization of 36 participants. Participants were enrolled at 13 centers in 6 countries (United States, Belgium, Spain, France, England, and Italy).|Participants were randomized 1:1 to the TheraSphere group or control group. To balance the treatment groups, participants were stratified at randomization on the basis of serum level of alpha-fetoprotein (AFP) (<400 nanograms/milliliter [ng/mL] versus >400 ng/mL) and study center.
728659|NCT01887678|A total of 28 investigational sites in the United States (US) entered at least one patient into the study database, 24 sites randomized at least one patient, 4 sites had Lead-In screening failures only.|In total, 287 patients were enrolled into the study, 55 of them were Lead-In screening failures and therefore were not included.
728660|NCT01887600|Study population consisted of anemic participants with stages 3, 4 or 5 chronic kidney disease (CKD) (Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2) who were not on dialysis. Participants were recruited from 125 study centers located in 22 countries.|A total of 594 participants with CKD were randomized to one of the 2 treatment arms in a 2:1 ratio receiving roxadustat or placebo. Anemia was defined as a mean Hb ≤ 10.0 g/dL upon repeated measurements during the screening period. Participants needed a ferritin ≥30 ng/mL (≥ 67.4 pmol/L) and transferrin saturation (TSAT) ≥ 5%.
728661|NCT01887587||
728662|NCT01887470||
728663|NCT01887418|Subjects were screened at 10 sites in USA. In total, 39 eligible subjects were enrolled and received study medication (investigational SC QST or IM RLD): 14 subjects in 50 mg SC QST arm, 15 subjects in 100 mg SC QST arm and 10 subjects in 200 mg IM RLD arm.|Eligible patients were randomized to receive SC 50mg (Treatment B) or SC 100mg (Treatment A) QST and the subject who were on IM testosterone replacement therapy, received IM TE RLD (Treatment C).
728664|NCT01887353||
728665|NCT01887327||
728666|NCT01887288||
728667|NCT01887210||
728668|NCT01887171||
728669|NCT01887132||5 participants signed consent. Only 4 started the study.
728670|NCT01886963||
728671|NCT01886937|37 patients were screened for eligibility between July 2012 and July 2013 at an academic medical center in New York City, NY.|13 of the 37 participants were randomized. Of those not randomized, 18 did not meet inclusion criteria and 6 chose not to participate.
728672|NCT01886872||Of the 644 patients screened, 52 did not meet eligibility criteria, 19 did not register per Investigator decision, 16 did not register per patient decision, and 10 did not register for other reasons; these patients are thus excluded from the study before randomization.
728673|NCT01886833|420 mother-infant pairs were recruited between April 2013-March 2014 from Kamwala Health Care Clinic during routine immunisation. Enrolled mother-infant pairs will undergo baseline procedures and were followed prospectively until March 2017 at scheduled visits at baseline, 1, 3, 12, 15 and 42 months. and unscheduled visits if infant was unwell.|
728674|NCT01886807||
729028|NCT01860521|September 2011 - June 2013. University Hospital.|
729029|NCT01860287||
729030|NCT01860170||
728675|NCT01886781|Patients were recruited at a private gastroenterology clinic in Port Elizabeth, South Africa between January 2011- June 2013,|Run-in phase of 1-2 weeks, then an 8 week treatment phase followed by a 2 week wash out period.
728676|NCT01886716||Random assignment occurred during Week 1, the next visit after the baseline orientation session. Out of 115 participants completing the baseline session, 21 dropped out prior to random assignment. To ensure current symptoms, another 8 were excluded due to baseline reports of no or extremely low alcohol consumption and/or social anxiety, leaving 86.
728677|NCT01886690||
728678|NCT01886313|Participants were recruited based on physician referral at 5 centers in the United States.|Subjects who met a minimum average daily pain score of ≥4 were equally randomized into either active or placebo groups.
728679|NCT01886300|Out of 335 participants planned to be enrolled in the study, only 16 participants were enrolled. The trial was conducted at 8 centers in Vietnam.|
728680|NCT01886287|This study was open to accrual at Moffitt Cancer Center 12/10/2013 through 10/10/2014.|
728681|NCT01886235||
728682|NCT01886105||
728683|NCT01885936||Three enrolled participants decided to withdraw due to travel difficulties.
728684|NCT01885910|Recruitment at 2 sites for subjects at least 12 years of age with moderate to severe acne vulgaris began June 2013 and ended December 2013|Any subject might be excluded who is not at least 12 years of age, who does not have moderate to severe acne vulgaris based upon IGA score and lesion counts, who has not completed the proper washout of specified medications, or who has been in another investigational study 30 days prior
728685|NCT01885897||
728686|NCT01885871||
728687|NCT01885559|Recruitment for HALT PKD Study B occurred at seven clinical sites between February 2006 and June 2009.|
728688|NCT01885208|Out of 146 sites selected for recruitment, 138 sites in 12 countries randomised subjects to the treatment viz. Argentina: 4 sites; Croatia: 5 sites; Finland: 5 sites; France: 7 sites; Germany: 7 sites; Greece: 5 sites; Italy: 6 sites; Netherlands: 8 sites; Serbia: 5 sites; Switzerland: 5 sites; United Kingdom: 6 sites and United States: 75 sites|
728689|NCT01885182|The recruitment period is from 2013 Jun to 2014 Jul and the type of location is medical clinic.|There is no run-in period for this study.
728690|NCT01885117|Subjects were enrolled from one center in Germany.|
728691|NCT01885104||
728692|NCT01885000||
728693|NCT01884844||
728694|NCT01884688||
728695|NCT01884675|A total of 160 participants were planned to be enrolled, however only 33 participants were randomized in the study.|This was a double-blind study which included clinic visits at Screening, Baseline visit, Weeks 4, 8, 12 and 16. A Follow-up visit was scheduled approximately 30 days after the Week 16 visit for those participants not continuing into study AMB116457 (Open-label extension study).
728696|NCT01884597||
728697|NCT01884571|Participants were recruited for this study from three Northeast ALS Consortium (NEALS) centers in the USA (Emory University in Atlanta, Georgia, Massachusetts General Hospital in Boston, Massachusetts, and University of Massachusetts Medical School in Worcester, Massachusetts. Recruitment occurred between October 2013 and October 2014.|
728698|NCT01884545||220 subjects were consented. Prior to randomization 9 subjects withdrew from the study, 10 were lost to follow up, and 1 did not meet inclusion criteria. 200 participants were randomized.
728699|NCT01884519||
728700|NCT01884350||1217 participants were enrolled, 1162 randomized (583 Primary SOC,579 AEP). 55 were enrolled but not randomized. Of the 55, 13 no longer met study criteria, 13 withdrew consent, 3 lost to follow-up, 10 other and 16 unknown.
728701|NCT01884337|This study was conducted in an Indian orthopedic population.|557 participants were enrolled, of whom 498 were treated. Of the 59 who were not treated, 42 no longer met study criteria, 6 withdrew consent, 11 due to other reasons. Of the 326 who started Total Knee Replacement, 324 continued into follow-up period and of the 172 who started Total Hip Replacement, 170 continued into follow-up period.
728702|NCT01884311||
728703|NCT01884077||
728704|NCT01884064||
728705|NCT01884025||
728706|NCT01883999||
728707|NCT01883986|We recruited 41 outpatients with lung cancer of any stage or type at the Puget Sound Health Care System within two months of diagnosis between 3/6/2014 and 9/1/2015. We reviewed weekly tumor board lists and consults to oncology and pulmonary services to mail invitation letters to eligible patients and then follow up by telephone.|Forty-one subjects completed informed consent and forty subjects were randomized. The subject who was consented, but not randomized, became ineligible by enrolling in hospice care.
728708|NCT01883908|University Medical Centers and Hospital Based Oncology Programs recruited participants from January 2013 until June 2014.|Four participants were enrolled, with three randomized to receive acupuncture and one randomized to receive standard medical care.
728709|NCT01883895||
728710|NCT01883856||
728711|NCT01883804|Participants were recruited through the adult clinic of the Barbara Davis Center, University of Colorado School of Medicine. Recruitment began in July of 2013 and concluded in November of 2015.|A total of 30 participants joined the study. Five participants withdrew prior to the first visit or any study procedures. The remaining 25 participants started the study and 20 completed all study visits and procedures.
728712|NCT01883635|Both cancer survivors and their caregivers were screened, consented, and randomized to one of two intervention arms (Individual Exercise or Dyadic Exercise). 22 cancer survivor/caregiver dyads were recruited (44 individuals).|
728713|NCT01883492||
728714|NCT01883453||
728715|NCT01883440||
728716|NCT01883427||
728717|NCT01883141||
728718|NCT01882985||
728719|NCT01882907||"Total number of patients who were in screening is 287. However, 59 patients were excluded. 49 Patients didn't meet inclusion/exclusion criteria. 10 Patients didn't take investigational product.
~As a result, 228 patients took investigational product."
728720|NCT01882868|The study was conducted at 19 sites in Japan. A total of 68 participants were screened between 30 July 2013 and 12 March 2014, out of which 62 were enrolled and treated.|Among 68 participants screened, 6 were screen failures due to elevated urine protein-creatinine ratio (UPCR) and inadequate liver function tests (LFTs).
728721|NCT01882829|Recruitment period from October 2013 to December 2015|
728725|NCT01882647|"Recruitment period: June 2013 to February 2014
~The location of clinical sites included dermatology clinics and clinical research centers."|All subjects who met the entry criteria were randomized and enrolled into the study.
728726|NCT01882543||
728727|NCT01882465|A total of 35 subjects were enrolled in this study. Of the enrolled 1 subject did not meet the eligibility criteria.|Of the remaining 34 subjects, 1 subjects withdrew consent before randomization and was discontinued from the study. A total of 33 subjects were dispensed a study lens. Of the dispensed subjects 2 were discontinued and 31 completed the study. A total of 3 subjects were discontinued from this study.
728728|NCT01882439|Data through End of Study (Month 6)|Of 546 participants screened for entry into the study, 395 were enrolled and randomized, 394 received treatment.
728729|NCT01882413||
728730|NCT01882257||93 subjects were enrolled in the study. 2 subjects were found to be ineligible due to level of spinal cord injury. 91 patients remained in the study and were asked to keep daily logs of symptoms. 17 subjects were unable or unwilling to come to the first study visit.
728731|NCT01882088|36 patients were enrolled. 1 patient withdrew informed consent before day 0, 1 excluded due to non-compliance, 1 could not tolerate oesophageal manometry, in 1 case there was no possibility to perform the manometry. Migration of the pH-impedance probe was found in two patients. The data of these mentioned 6 patients were excluded from the analysis|
728732|NCT01882062||
728733|NCT01881984||
728734|NCT01881932|University Medical Centers and Hospital Based Oncology Programs recruited participants from February 2013 until June 2014.|Nineteen patients were enrolled and randomly assigned to one of three arms: a) real acupuncture, b) sham acupuncture or c) standard of care. Two patients received standard of care, 4 real and 13 sham.
728735|NCT01881867||
728736|NCT01881828||
728737|NCT01881776|St Luke's-Roosevelt Hospital Center between August 2011 and June 2012|One patient enrolled preferred to get SISB instead of GA and was therefore not randomized to treatment.
728738|NCT01881750|Recruitment occurred over 2 years (July 2010-June 2012). Participants were recruited through distribution of fliers at clinics and autism awareness events, referral by local professionals, and word of mouth.|One hundred and thirty-five potential subjects were screened after inquiring about the study; 104 signed a consent form. Forty one did not meet eligibility criteria and 10 decided not to participate before baseline measures.
728739|NCT01881737|Participants recruited between November 2011 and September 2013 at Stanford University.|
728740|NCT01881620||
728741|NCT01881412||
728742|NCT01881373|communities were selected where >25% of the population was of indigenous/native descent (native to each jurisdiction), >10% of the population was under age 10 years, >1000 population size, and communities were relatively accessible|Eighteen selected communities were matched for size and randomized within jurisdiction to intervention or control. Nine additional communities were monitored with no randomization for temporal trends of obesity. 2-8 year old children and their households and environments were measured and evaluated in each of these communities.
728743|NCT01881230|"This multicenter study was conducted by investigators in 11 countries in North America, Europe, Australia and South America, and enrolled participants at a total of 86 sites.
~Due to changes in the treatment landscape since the initiation of this trial, the decision was made not to proceed to the Phase 3 portion of the study."|Participants were randomized 1:1:1, stratified by disease free interval (≤ 1 year; > 1 year).
728744|NCT01881126||
728745|NCT01881113|Subjects were recruited from three sites in the US.|There were 101 subjects enrolled, 14 subjects discontinued, and 87 subjects completed the study. Participant flow and baseline characteristics are presented for the 101 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or Vehicle.
728746|NCT01881087||
728747|NCT01881009|Recruitment included mailing/emailing/calling to the families who registered the camp sessions when this study was conducted. Other sources of recruitment included chart review, Stanford Peds Endo Facebook page, Stanford Peds Endo website, support groups, department newsletter, clinic visits, and group visits.|
728748|NCT01880840||
728749|NCT01880736|The trial was conducted at 39 sites in Japan.|Pre-assignment: Subjects switched from their pre-trial IGlar to IDeg unit-to-unit and continued pre-trial OADs (maximum of 3) at unchanged doses and frequency.
728750|NCT01880723||
728751|NCT01880697||
728752|NCT01880593|Recruitment from May 2013 through Sept 2016|
728753|NCT01880528||
728754|NCT01880515||
728755|NCT01880437|A total of 47 participants were screened; of which,7 participants failed screening and 2 participants were erroneously entered but did not receive study drug.A total of 38 participants were enrolled and treated. It was planned to enroll 2 cohorts; Cohort 1 (vismodegib) and Cohort 2 (vismodegib + cytarabine).|"Based on lower-than-expected efficacy observed in interim data review, study was terminated prior to initiation of Cohort 2. Results are reported as per subgroups of Cohort 1: Poor Risk Cytogenetics, FLT-3 Mutation Positive, Neither Poor Risk Cytogenetics Nor FLT-3, unless otherwise specified."
728756|NCT01880424|Patient recruitment occurred over an 18-month period from July 2013 to January 2015 at 98 study centers (40 in China, 42 in the US, 10 in Australia, 5 in New Zealand, and 1 in Canada).|Patients went through a 14 to 21-day Pretreatment Period during which they provided qualifying bowel habit and symptom severity assessments and rescue medicine usage through an electronic diary (eDiary). 1722 patients provided consents with 839 qualified to join th study.
728757|NCT01880320||
728758|NCT01880099||
728759|NCT01880086||
728760|NCT01880073||
728761|NCT01880047||One splenectomized subject was removed from the study because of increased bone marrow reticulin, prior to receiving any study drug
728762|NCT01879852||29 subjects were consented to the study. During pre-surgery (baseline) testing, 2 subjects were found not to have a meniscal tear (inclusion criterion) and were withdrawn from the study. Total number of subjects meeting eligibility criteria was 27.
728763|NCT01879826||
728764|NCT01879800||
728981|NCT01864005|First subject enrolled: 15/05/2013, Last subject last visit: 18/03/2014. There were 5 study centers in China, which participated this study.|There was no run-in or any other pre-assignment periods following participant enrollment.
728765|NCT01879735|"10 healthy subjects were recruided after they responded to an advertisement in the local newspaper.
~12 patients with varying degree of cholestasis and different underlying diseases were recruided from the Department of hepatology and gastroenterology Aarhus University Hospital."|
728766|NCT01879722|Participants took part in the study at 1 investigative site in the United States from 21 June 2013 (First participant signed consent) to 23 June 2014.|Participants with a diagnosis of Schizophrenia were enrolled into 1 of 6 treatment groups, once a day placebo, 3 mg, 10 mg, 20 mg, 30 mg or 100 mg TAK-063. Healthy Japanese participants were enrolled in 1 of 4 treatment groups, once a day placebo, 3 mg, 10 mg or 20 mg TAK-063.
728767|NCT01879683||
728768|NCT01879618|The study was conducted in 12 sites in Canada, 10 of which enrolled participants. A total of 152 participants with chronic renal failure, who had at least 30 previous days of hemodialysis (HD) and had received ≤10,000 IU unfractionated heparin or low molectular weight heparin for anticoagulation during the past month were enrolled in the study.|The Screening Visit was performed within 9 days preceding first HD session where FRAGMIN was administered. The Final Study Visit took place 5 to 15 days after the final study HD session where the participant was treated with Fragmin (# 20 or the last HD session that was completed, if the partcipant prematurely terminated).
728769|NCT01879579||
728770|NCT01879553|Subjects recruited from a single center in Belgium|
728771|NCT01879540||
728772|NCT01879410||A total of 700 participants representing the enrolled participants, were randomized to study treatment. Of these, 697 comprised the Intent-to-Treat Population (participants randomized to treatment who received >=1 dose of randomized study medication in the treatment period).
728773|NCT01879371|36 healthy male and female subjects (at least a third of each sex) were recruited from the volunteers' pool of the Human Pharmacology centre of BI Pharma GmbH & Co. KG, Ingelheim, Germany.|
728774|NCT01879345||
728775|NCT01879332||
728776|NCT01879319|Eligible patients were men and women ≥ 18 and ≤ 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL, fasting triglycerides ≤ 400 mg/dL and on a stable dose of a statin with or without ezetimibe for at least 4 weeks. The first patient enrolled on 11 July 2013 and the last patient enrolled on 20 September 2013.|Randomization was stratified on the basis of screening LDL-C concentration (< 130 mg/dL [3.4 mmol/L] or ≥ 130 mg/dL). Participants were trained by study site staff to prepare and self-administer the study drug.
728777|NCT01879176||
728778|NCT01879072||
728779|NCT01879059||
728780|NCT01878825||1 volunteer was assigned a subject number but was subsequently determined to be ineligible for study participation and was never vaccinated.
728781|NCT01878812||
728782|NCT01878799||
728783|NCT01878786||
728784|NCT01878656||
728785|NCT01878604||
728786|NCT01878526||
728787|NCT01878383||
728788|NCT01878292||Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study
728789|NCT01878253||
728790|NCT01878214|We invited 1937 union members to participate; 1638 members completed the baseline survey (84.6%). Of those, 553 were current smokers, 1066 were non-smokers, and the smoking status was unknown for 19 individuals. The smoking rate was 33.8%, slightly lower than expected based on previous studies in this population.|Of 553 current smokers, 111 were not eligible for study inclusion because they either did not sign a consent form (n=49), were not eligible for union benefits (n=57), or had too much data missing at baseline (n=5). The 442 eligible smokers were separated into the four segments and then randomized into the intervention group or the control group.
728791|NCT01878175||
728792|NCT01878149|Consecutive subjects at each site meeting all of the study eligibility criteria and who were treated with LLIF using the VEO® or XLIF® systems at least 3 months prior to the date the data is collected were included in this evaluation.|The Sponsor originally collected data on 38 subjects, 21 subjects in the VEO treatment arm and 17 subjects in the XLIF® treatment arm, from a total of five sites. Four study subjects (two subjects from each study arm) were excluded from the final evaluation as they did not meet the inclusion/exclusion criteria.
728793|NCT01878097|A total of 89,707 students completed surveys. However, due to anonymous response, it is not possible to know the number of unique students who completed surveys within the study period. Two schools within each of the 13 regions were selected by the Rape Crisis Centers for simple randomization to each condition in this cluster RCT (n=26).|46 demographically similar public high schools were identified as willing participate in the trial. Two schools were excluded by researchers because these were too small (<100 per grade). Among the remaining 36 schools, two schools within each of the 13 regions were selected and randomized (n=26).
728794|NCT01878084|participants were recruited from the outpatient clinic of the orthodontic department at the Faculty of Dentistry of Alexandria University From October 2013 to October 2014|
728795|NCT01878006||15 subjects were consented for the trial, but 10 subjects were found eligible to start the study.
728796|NCT01877941||
728797|NCT01877915||A total of 3 participants randomized twice were only counted once in the ITT analysis set (comprised of 5,022 participants).
728798|NCT01877720||
728799|NCT01877668||Of 611 participants screened for entry into the study, 422 received treatment.
728800|NCT01877655|A total of 514 participants were enrolled across 11 countries. At least 30% of enrolled participants had cytomegalovirus (CMV) seronegative donor and underwent allogeneic hematopoietic cell transplant (HCT). After the primary study period (day 365) participants were monitored for 5.5 years post-transplant for long-term safety.|Screening assessment occurred from 30 to 5 days before transplant. Participants who met the inclusion and none of the exclusion criteria were randomly assigned in a 1:1 ratio to receive either ASP0113 or placebo. The randomization to treatment was stratified by donor-recipient relatedness and by donor CMV serostatus.
728801|NCT01877642||
728802|NCT01877564|Participants were recruited from the UAMS Gynecologic Oncology Clinic between August 2013 and July 2016.|Subject eligibility was established before treatment randomization and included eligibility assessments, study assessments, lab tests, and pathology assessments.
728803|NCT01877551||
728804|NCT01877538||
728982|NCT01863953||
728805|NCT01877421|There were a total of 137 planned subjects (71 in Phase 1 and 66 in Phase 2) to participate in this study at the Oral Health Research Institute, Indiana University School of Dentistry. There were a total of 135 enrolled (71 in Phase 1 and 64 in Phase 2). Phase 1 and 2 are individual periods ran in parallel.|
728806|NCT01877408|Recruitment occurred between 31 May, 2013 and 26 June, 2013. Participants were recruited via posters at two affiliated primary care clinics in Cape Town.|Healthy, uncircumcised men who were at least 18 years of age were eligible to participate in the study. All those who were enrolled and who showed up for their procedure were included in the study.
728807|NCT01877343||Patients recruited only from two of the study groups (control and post-transplant). Patients from the other groups were not included as study team assessed feasibility with the non-heart failure groups prior to consenting high failure patients. Enrollment was challenging for high risk patients due to stress test severity.
728808|NCT01877278||
728809|NCT01877265||LY2605541 was manufactured using the 3 different polyethylene glycol (PEG) sources (referred to as Source 1 [LY1], Source 2 [LY2], and Source 3 [LY3]). Participants were randomized to 1 of 6 treatment sequences and received a single injection of LY1, LY2, or LY3 on Day 1 of each of 3 treatment periods according to their assigned treatment sequence.
728810|NCT01877239||A total of 111 participants were enrolled in the study but due to the loss of all study data and material at one site with 35 participants, the number of participants that could be included in the analysis was 76.
728811|NCT01877187||
728812|NCT01877161|recruitment period : 2012.12.05-2013.03.07 type of location: medical clinic through public announcement|15 participants recruited: 15 screened, 0 excluded, 3 participants dropped out (3 participants withdrew because of their long-distance commute before group assignment)
728813|NCT01877148||
728814|NCT01877083|Participants took part in the study at 14 investigative sites in the United States, Japan, Singapore, and Taiwan from 05 April 2013 to 2 November 2017.|A total of 25 participants with kinesin family 5B oncogene rearranged during transfection (KIF5B-RET)-positive adenocarcinoma of the lung or other RET translocations were enrolled and treated, 5 participants were ongoing in the Extension Phase at the time of data cut-off.
728815|NCT01876992|Patients recruited through the Clinical Research Center.|
728816|NCT01876979||
728817|NCT01876823|35 depressed and cognitively impaired patients were recruited from the Late Life Depression and Memory Disorders Clinic at Columbia University Medical Center.|Any patients who were diagnosed with schizophrenia, psychoses, bipolar disorder, or alcohol/substance dependence (within the last 6 months) were excluded from participating in the study. Patients already on an effective anti-depressant, non-responders to citalopram/es-citalopram, and those on cholinesterase inhibitors/memantine were also excluded.
728818|NCT01876810||1 participant was excluded after enrollment after disclosure of a mental illness which is an exclusion criteria.
728819|NCT01876784|The study was conducted at 66 centers in 12 countries. A total of 299 participants were screened between 17 September 2013 and 26 September 2014 of whom 238 participants were randomized and 235 were treated.|
728820|NCT01876732|Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.|
728821|NCT01876706||
728822|NCT01876511||
728823|NCT01876485||
728824|NCT01876446||
728825|NCT01876420||
728826|NCT01876381||
728827|NCT01876368||
728828|NCT01876329||
728829|NCT01876251||30 participants were enrolled of whom 1 was not treated and therefore 29 participants are stated below as starting the study.
728830|NCT01876212||
728831|NCT01876043||
728832|NCT01875991|"Adults (≥ 18 years) with moderate to severe rheumatoid arthritis (RA) or plaque psoriasis (PsO) and candidates for treatment with etanercept (Enbrel) in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept.
~First patient enrolled on 05 June 2013; last patient enrolled 03 January 2014."|Randomization was stratified by disease state (RA and PsO). Each participant served as his or her own control in this crossover study.
728833|NCT01875978|Study from Oct. to Dec.2012 in China Medical University Hospital -Taipei branch Initially,51 patients screened .Finally, 40 patients were enrolled.|Statins, red yeast rice, omega-3 ,fibrates were excluded.
728834|NCT01875874||
728835|NCT01875861|Twelve sites were recruited, matched according to level of organizational readiness-to-change, and randomized to intervention/control group within each of the 6 site-pairs. Patients with a new antipsychotic medication start were identified using VA data in 6-month pre-implementation, implementation, and sustainability periods.|Participants were continuously entered into the study when starting a new antipsychotic treatment and were assessed up to 120 days later, thus the number of participants within each period is independent of one another and for some participants where the 120 days spanned two periods they are counted in more than one period.
728836|NCT01875848|Identify potentially eligible individuals that are prescribed an active opioid of 30-100mg. Patients are screened through medical records and referral from primary care providers in addition to a opt out letter and follow up phone call.|
728837|NCT01875783||
728838|NCT01875731||
728839|NCT01875510||
728840|NCT01875471||A total of 279 subjects were enrolled in the study; 4 did not meet the eligibility criteria, 2 prematurely discontinued and 273 completed the study. Of those 273 completers, 23 were excluded from the primary analysis due to major protocol deviations; hence, 250 completed the study per protocol and were included in the analysis.
728841|NCT01875445||
728842|NCT01875250||
728843|NCT01875237|patient with hematologic malignancies receiving allogeneic hematopoietic transplants.|patients who do not have GVHD on day 42 receive genetically modified donor lymphocytes with suicide gene to be activated by drug AP1903 if GVHD occurs.
728844|NCT01875185||
728845|NCT01875159||
728889|NCT01871077|A total of 32 ophthalmologically healthy volunteers were evaluated, to which both eyes, with no history of any systemic or ophthalmological disease, who were not using any type of medication, and who agreed to participate in the study and met all the inclusion criteria described in the section.|Only 30 were selected and 2 discarded because they met the exclusion criteria.
728846|NCT01874951|After approval by our Institutional Review Board (IRB), written informed consent was obtained. Boston area men and women with major depressive disorder (MDD) were recruited from 01/13/2014-11/11/2014 via IRB-approved newspaper, television, internet, and radio ads initiated by Massachusetts General Hospital (MGH) and Boston Clinical Trials (BCT).|21 prospective subjects were screened. The following were excluded: sub-threshold Hamilton-D (HAMD) scores (n=3); too recent changes in medication regimen (n=2); cerebrovascular accident in past 5 years (n=1); no history of past treatment response (n=1); inappropriate antidepressant (n=1); antidepressant dose too low and duration too short (n=1).
728847|NCT01874756||
728848|NCT01874665||
728849|NCT01874535||
728850|NCT01874353|The first patient was screened on 03 September 2013 and the last patient was screened on 21 November 2014. Patients were screened at 119 centres in 16 countries. Of the 602 patients screened, 295 were randomized.|It was planned that approximately 264 women with BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy were to receive olaparib 300 mg bd or matching placebo in a 2:1 ratio.
728851|NCT01874340||
728852|NCT01874288||
728853|NCT01874275||
728854|NCT01874262|The first participant was enrolled on 30 June 2013 and the last participant completed the study on 11 December 2014. Study participants were randomized from 15 centers in Sweden.|Before discharge from the hospital patients diagnosed with myocardial infarction and treated with ticagrelor were offered participation in the study and those that accepted and signed informed consent were randomized into one of the two study groups.
728855|NCT01874145||"A total of 218 patients with a confirmed and documented RRMS diagnosis were screened for enrollment into this study. Of the 9 patients who were screened but not randomized, 3 were excluded for not meeting the inclusion criteria, 3 were excluded for meeting an exclusion criterion, and 3 were not enrolled for other reason."
728856|NCT01874132||
728857|NCT01874119||
728858|NCT01874054|June 2013 - July 2016|
728859|NCT01873989||
728860|NCT01873950||52 healthy volunteers were assessed for eligibility. 24 subjects were excluded because they did not meet the inclusion criteria. 22 of 28 subjects who met the inclusion criteria were randomized and allocated to receive crossed-over intervention. Williams Latin square design balanced for first-order carryover effects was used for randomization.
728861|NCT01873859||
728862|NCT01873846||
728863|NCT01873742|Data were collected from 2013 to 2016 from three couple and family therapy sites in Norway.|
728864|NCT01873729||
728865|NCT01873586|Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).|
728866|NCT01873495|Patients were enrolled between 5/8/2013 and 7/23/2018 at Winship Cancer Institute of Emory University.|
728867|NCT01873417||
728868|NCT01873287||
728869|NCT01872910||Participants were randomized to treatment groups when their dental pain intensity post oral surgery was moderate (or severe) as reported on a categorical 4-point scale: 0 (absent) to 3 (severe) and were marked on a 100 millimeter (mm) straight line visual analog scale (VAS) with a pain score ≥40 mm: 0 mm (no pain) to 100 mm (worst pain imaginable).
728870|NCT01872819||
728871|NCT01872715||
728872|NCT01872689||A total of 505 participants (154 participants in Monotherapy Cohort and 351 participants in Combination Therapy Cohort) were enrolled in the study.
728873|NCT01872611|Participants were recruited from 73 investigational centers located in the U.S., Europe, the Middle East, Africa, Latin America, the Caribbean, and the Asia Pacific region.|Of the 819 participants enrolled, 191 were exited as screen failures and 23 were discontinued prior to randomization. This reporting group includes all randomized participants (605).
728874|NCT01872338||
728875|NCT01872325||
728876|NCT01872078|67 patients were recruited to the study, of which 65 received doses of AZD4901 between 20 mg qd and 40 mg bid or placebo. Two patients were excluded due to poor venous access|
728877|NCT01871870||
728878|NCT01871805||
728879|NCT01871558||
728880|NCT01871545|Enrollment from June 2013 through February 2018|
728881|NCT01871532||
728882|NCT01871519|A total of 354 subjects were enrolled in this study. Among them, 350 subjects had BKP surgery and 4 subjects were not treated with BKP. Two of the non-treated subjects voluntarily withdrew from the study and 2 subjects were lost-to-follow-up before surgery.|
728883|NCT01871506|Between 11/25/2013 and 7/1/2017 4709 patients were screened for eligibility. 2659 were eligible based on screen criteria; 1808 did not complete the screen. Of the 851 who were approached to complete the screen, 405 were ineligible, 303 enrolled and were randomized, and 143 refused (84 refused consent and 59 did not complete the baseline survey)|Of the 446 eligible for the study, 303 were randomized, 84 were eligible but refused consent (top 3 reasons: too upset, did not need help, had no time) and 59 were eligible but were not randomized because they did not complete a baseline survey.
728884|NCT01871441||
728885|NCT01871402|"Recruitment period: May 2013 to December 2013
~The location of clinical sites included dermatology clinics and clinical research centers."|All subjects who met the entry criteria were randomized and enrolled into the study.
728886|NCT01871285|Subjects with at least 6 months history of chronic pain requiring around-the-clock (ATC) opioid therapy with 80 to 220 mg morphine sulfate equivalent (MSE) per day for at least 28 days|Subjects were enrolled and entered a screening period (73). Those meeting criteria for study entry including positive precipitated withdrawal during naloxone challenge (39) were randomized and stratified to 2 dose groups (subjects requiring 80-160 mg MSE/day ATC to MSE Dose Group 1 and subjects requiring 161-220 mg MSE/day ATC to MSE Dose Group 2).
728887|NCT01871142||
728888|NCT01871090|Subjects enrolled from 20-September-2013 to 14-April-2015 from the Genesis Healthcare Emergency Department located in Zanesville, Ohio.|There were 16 screen failures because at the time of their enrollment, the patient group had met maximum enrollment for their patient group (compatible vs. non-compatible cardiac device) under the initial protocol.
728890|NCT01870999||
728894|NCT01870856|Participants were recruited from 23 study centers located in the US.|Of the 187 enrolled, 135 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants. Results from Stage 1 were planned to be used to appropriately power Stage 2 of the study. Since primary efficacy cannot be demonstrated in Stage 1, Stage 2 of this study was not conducted.
728895|NCT01870843|The study was conducted between 09 April 2014 and 04 May 2015 and recruited participants from 10 study centers in China.|Of the 261 participants enrolled, 241 participants were included in the Full Analysis Set.
728896|NCT01870778||6600 participants were randomized into the trial. Only 6545 participants were eligible for analysis. Therefore, the participants flow and baseline characteristics are based on 6545 participants.
728897|NCT01870739|"A total of 115 patients were enrolled. One patient was discontinued after randomization before receiving any dose of study randomized medication.
~A total of 114 patients received study randomized medication"|
728898|NCT01870726||A total of 43 patients enrolled in this trial, 33 patients in the Phase Ib part of the study (patients were assigned to 6 dose combinations of INC280 with buparlisib) and 10 patients in the Phase II part of the study.
728899|NCT01870596||
728900|NCT01870583||
728901|NCT01870401|Participants were recruited from medical clinics and hospitals between June 2013 and January 2018. The first participant was enrolled on June 3, 2013 and the last participant enrolled was on December 12, 2017.|
728902|NCT01870388||An interim analysis was to be performed after ≤6 participants (pts) each in Group (G) 1 and G2 completed the study. If a <1.3-fold difference in exposure was seen between pts with moderate hepatic impairment (G2) and pts with normal hepatic function (G1), then pts with mild hepatic impairment (G3) were not to be enrolled. No pt was enrolled in G3.
728903|NCT01870297||Dose escalation was planned for 20 milligrams (mg) of LY3025876 but dose escalation was only up to 15 mg LY3025876.
728904|NCT01870076|The elective surgery patient list was assess for eligible patients. Those scheduled patient meeting inclusion criteria between 5-25 years of age were invited to participate in the study.|Upon verbal agreement, study randomization was assigned and a study consent was mailed to the patient. Arrangements for arrival time the night before surgery for the study procedures were made. After arrival to the unit the guardian reviewed the consent with study staff and upon written consent, study procedures began based on randomization.
728905|NCT01869959||
728906|NCT01869777||
728907|NCT01869764||
728908|NCT01869699||
728909|NCT01869686|First patient enrolled 17 June 2013; last patient enrolled 17 June 2013.|
728910|NCT01869647||
728911|NCT01869634||
728912|NCT01869478||
728913|NCT01869439||
728914|NCT01869374||Five-day washout from all anti-depressants and mood stabilizers.
728915|NCT01869348||
728916|NCT01869192||
728917|NCT01869075|Recruitment of study sites not individual patients.|After site enrolment, baseline data was collected for all sites in order to establish sample size for phases 1 and 2.
728918|NCT01868997||A total of 88 participants were enrolled (all participants who signed informed consent were considered enrolled in this study); 1 participant was never dosed and early terminated.
728919|NCT01868893|A total of 20 participants were enrolled at 7 study sites in the United States (U.S) between 21 August 2013 and 22 January 2014.|Of 20 participants, one patient withdrew from the study due to neutropenia and did not receive any study drug.
728920|NCT01868789||
728921|NCT01868776||
728922|NCT01868646||"Selection procedures were carried out after participant enrollment to determine whether the patient could participate in the study in accordance with the inclusion/exclusion criteria.
~Of the 190 patients enrolled, 42 did not meet inclusion criteria after screening procedures, they were not randomized"
728923|NCT01868633||
728924|NCT01868594|The study enrolled patients using intensive insulin regimen (Short-acting and Long-acting human insulins) with type 1 diabetes who were not meeting glycemic control (HbA1c>7.0%). Eligible patients were assessed by endocrinologists. The study was performed in 15 medical institutions in Russia from May 2013 to October 2015.|"Selection procedures were carried out after participant enrollment to determine whether the patient could participate in the study in accordance with the inclusion/exclusion criteria.
~Of the 200 patients enrolled, 49 did not meet inclusion criteria after screening procedures, they were not randomized"
728925|NCT01868542|The trial was conducted at 6 sites in 1 country: South Korea|
728926|NCT01868503||
728927|NCT01868477||Twenty-three patients were randomized into the trial
728928|NCT01868425||
728929|NCT01868334||
728930|NCT01868243||
728931|NCT01868165||Participants had hypertension and treatment with antihypertensives.The study examined the cognitive change in older adults taking antihypertensives with a particular focus on Calcium Channel Blockers (CCB). Cognitive function was tested at 0 & 12 months. Participation in the study had no impact on treatment.
728932|NCT01868139||
728933|NCT01868074|"Recruited from clinics affliated with the University of Iowa Hospitals and Clinics; from the clniical trials Website; and from local day care facilities, schools, and pregnancy excercise classes.
~Exclusion criteria included women participating in in vitro fertilization, previous lower limb or spinal surgery, & chronic diseases."|
728934|NCT01868035||All participants were treated with 6 to 8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy, and were required to have a response (complete response [CR], complete response unconfirmed [CRu], partial response [PR]) to be eligible for Tositumomab and iodine I 131 tositumomab (TST/I 131 TST) therapy.
728935|NCT01868022|This was a non-randomized, parallel-group study in participants (par.) with Solid Malignancies and Deregulated Fibroblast growth factor (FGF) Pathway Signaling. Participants administered GSK3052230 in combination with paclitaxel + carboplatin (Arm A) or in combination with docetaxel (Arm B) or in combination with pemetrexed + cisplatin (Arm C).|Total 65 participants were enrolled in 3 Arms. In Arm A 20 participants were enrolled across 3 cohorts, Arm B 9 participants were enrolled across 3 cohorts, Arm C 36 participants were enrolled across 3 cohorts.The study was conducted at 22 centers across 7 countries from 9-Oct-2013 to 24-Oct-2017.
728983|NCT01863771||
728984|NCT01863758||
728936|NCT01868009|A total of 314 participants were screened; 287 participants were randomized, and 283 participants completed the study.|Eligible participants were randomized (1:1) to one of the two sequences of using the two placebo dry powder inhalers (ELLIPTA once a day then DISKUS twice a day or vise versa), each one taken separately for approximately 1 week. The first inhaler in the sequence was dispensed at Visit 1 and the second at Visit 2.
728937|NCT01867710||
728938|NCT01867671|Participants ages 1 to 3 with a clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut were recruited from 5 clinical centers in the United States from August 2013 to October 2015.|Individuals with a history of severe anaphylaxis (previous hypotension) to peanut were excluded.
728939|NCT01867658|Enrollment began in June 2013. 112 subjects were treated across 15 sites.|207 subjects were consented and 112 were treated with Progel® PALS. Of the subjects who were not treated, 69 failed to meet intra-operative inclusion criteria (54/94 screened video-assisted subjects and 15/87 screened robotic assisted subjects) and 11 did not have a video or robotics procedure performed (ie, converted to open thoracotomy)
728940|NCT01867632||
728941|NCT01867606||
728942|NCT01867580||
728943|NCT01867515||
728944|NCT01867424||
728945|NCT01867307|39 subjects were enrolled in the trial; 37 subjects were treated with the trial treatment, 2 subjects were not treated with the trial treatment (1 subject from type 2 diabetes mellitus (T2DM) patients arm and 1 subject from the Healthy subjects arm were not treated)|
728946|NCT01867294|Study II was never opened due to the accrual rate in Study I.|
728947|NCT01867216||
728948|NCT01867164||
728949|NCT01867086|This study recruited subjects from CL-PTL-105 who recurred and were either randomized to the control/observation arm (Group B) or screen-failed but had successful manufacturing of Vigil (minimum of 4 doses).|1 subject was enrolled and administered Vigil plus Carboplatinum. This subject did not complete treatment due to disease progression.
728950|NCT01867047|Patients were prescreened by the study team and then identified and presented to the surgeon during the preoperative clinic visit. Once IRB approval was granted on 8-9-2012 study team started screening the clinic schedule for potential participants.|Randomization of participants occurred only if the proposed inclusion/exclusion criteria were met.
728951|NCT01867021|A total of 24 sites with 3 sites in Thailand, 4 sites in Philippines, 15 sites in South Africa and 2 sites in Czech Republic.|All enrolled subjects were included in the trial.
728952|NCT01866943||
728953|NCT01866917||
728954|NCT01866839||1 participant signed consent but did not start study
728955|NCT01866826||Upon completion of a 4 week course of rifaximin or placebo subjects will undergo a 4-6 week washout period and cross over treatment assignments to complete a 4 week course of either rifaximin or placebo.
728956|NCT01866709||
728957|NCT01866592||
728958|NCT01866423|Participants were recruited at the University of Southern California (USC) medical clinics from December 2013 to February 2014. Due to results of two phase III clinical trials in metastatic, castration resistant prostate cancer (mCRPC), the sponsor determined that the drug has not demonstrated a clinical profile sufficient to move forward in mCRPC.|The trial had no pre-assignment criteria. All subjects were given the same treatment.
728959|NCT01866410||
728960|NCT01866319|Participants with advanced melanoma were recruited to receive ipilimumab once every 3 weeks (Q3W), or a primary course of pembrolizumab administered every 2 weeks (Q2W) or every 3 weeks (Q3W).|834 participants were randomized 1:1:1 to receive ipilimumab Q3W, pembrolizumab Q2W, or pembrolizumab Q3W. For participants receiving pembrolizumab, all safety and efficacy results data reported are for the primary pembrolizumab course received.
728961|NCT01866306|Male and female healthy participants, and participants with mild-moderate asthma between the ages of 18 and 55 years (inclusive) were enrolled in this trial.|
728962|NCT01866293|Protocol Open to Accrual 05/28/2013 Protocol Closed to Accrual 09/16/2015 Primary Completion Date 08/18/2016 Recruitment Location is the medical clinic|
728963|NCT01866163|First Subject First Visit: 17-Jun-2013 Last Subject Last Visit: 02-Oct-2013|Prior to randomisation, the subject entered a washout phase (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The wash-out/screening phase could last for up to 4 weeks, depending on which disallowed treatments the subject received.
728964|NCT01866150||Retrospective data was collected for 450 participants of whom 151 received biologic monotherapy, 289 received biologic combination therapy and 10 could not be categorized. Participant flow and baseline characteristics are presented for overall population and endpoints are presented for individual group.
728965|NCT01866098||
728966|NCT01865812|Recruitment started 19 Nov 2013 and completed 16 May 2014 in the primary treatment phase. Thirty-three subjects were screened and twenty-six enrolled.|Screening window was up to 20 days in duration to assess eligibility. Stable dose of ursodeoxycholic acid for 3 months prior to Day 0 required. 28 day washout period for Bile Acid Sequestrants, and no serum-lipid modifying agents for 3 months prior to Day 0. Subjects may participate in an open label Long Term Safety Extension (LTSE) study.
728967|NCT01865747|First patient enrolled: 08 August 2013, Data cut off date: 22 May 2015|
728968|NCT01865708||
728969|NCT01865552||
728970|NCT01865487||
728971|NCT01865448|Study performed in a single center. The patients attending the Endocrinology and Nutrition Department at the Hospital Clinico Universitario of Valladolid to receive treatment for obesity were consecutively enrolled in this study.|
728972|NCT01865084||
728973|NCT01864564||
728974|NCT01864538||
728975|NCT01864525||
728976|NCT01864434||
728977|NCT01864291||
728978|NCT01864200||
728979|NCT01864174|1736 enrolled at 148 study sites in North America, Europe, and South Africa.Lead in period=794. Reasons not entered: 1 AE, 17 WC, 4 lost to FU, 3 NC, 911 SC, 4 ARS, 1 other. Adverse event=-AE, Withdrew consent=WC, Follow-up=FU, poor/non-compliance=NC, No longer met study criteria=SC, Administrative reason by sponsor=ARS.|570 completed lead-in period and were eligible for randomization. 568 randomized. Non-randomized: 1 AE, 27 WC, 3 lost to FU, 7 NC, 159 SC, 8 ARS, 3 other.
728980|NCT01864148||A total of 419 participants were randomized; 1 participant was not dosed.
728985|NCT01863732|CAIN457F2305 core study consisted of a screening period of 4 Wks before randomization followed by a treatment period of 2 years (Wk 0 through Wk 104). At Wk 104, patients continued into the extension on the same dose of AIN457. If they were on Placebo in the core then randomized to either Group 1 or 2.|Group 1: AIN457 75mg plus placebo 150mg dosed every 4 weeks from Wk 104E1 to Wk 152. At Wk 156 (after unblinding), only AIN457 75mg was dosed or up titrated to AIN457 150mg. Group 2: AIN457 150mg plus placebo 75mg dosed every 4 weeks from Wk 104E1 through Wk 152. At Wk 156 (after unblinding), only secukinumab 150 mg was dosed.
728986|NCT01863680|First subject/Last subject (signed informed consent form [ICF]): 22 Jul 2013/02 Jun 2014; Study completed: 14 Oct 2014; Data base lock: 12 Nov 2014.|A total of 195 subjects were screened and 178 subjects were enrolled in the trial; 169 subjects started controlled ovarian stimulation (COS) treatment and 149 subjects received at least 1 dose of investigational medicinal product (IMP), 123 subjects have undergone in-vitro fertilization/ embryo transfer (IVF/ET).
728987|NCT01863667||"The study had a 1-week Screening Period; an oral antihyperglycemic agent (AHA) wash-off period of 8 weeks for participants on oral AHAs; a 2-week single-blind placebo run-in period; and a 54-week double-blind treatment period."
728988|NCT01863563|Tertiary children's hospital enrolled 100 consectutive children|
728989|NCT01863498||
728990|NCT01863433|The study was open label, non-randomized with single group assignment in healthy volunteers aged 18 to 60 years.|
728991|NCT01863368|Subjects were recruited from 13 study centers located in France and 3 study centers located in Germany.|Of the 105 enrolled, 11 subjects were exited prior to randomization: 9 screen failures, 1 adverse event, and 1 lost to follow-up. This reporting group includes all randomized subjects (94).
728992|NCT01863134|Four clinical centers located within a radius of 50km of the reference center were selected for the study. From 2005 to 2010 a total of 140 patients presenting with NSTE-ACS not eligible for PCI were enrolled to the study. All CABG procedures were performed at 1st Department of Cardiac Surgery, Silesian Medical University in Katowice.|
728993|NCT01863030|Subjects with a diagnosis of a ventral or incisional hernia requiring surgical repair to close the defect were recruited. First subject enrolled June 2013. The last subject was enrolled August 2014.|
728994|NCT01863017||
728995|NCT01862991||
728996|NCT01862874|A total of 1129 participants were screened and 1124 were randomized.|
728997|NCT01862796||100 participants were assessed for eligibility, 30 were ineligible and 9 did not complete the run-in phase. Sixty-one were assigned to groups.
728998|NCT01862640|Participants who met all the inclusion and none of the exclusion criteria were enrolled in this study. The study was conducted in 433 participants at 81 sites in 7 countries: Croatia, Germany, Serbia, Spain, Russia, Ukraine, and the United States.|Participants attended a screening period ranging from 2 to 42 days. The purpose of the screening period was to determine the participant's eligibility and to washout prohibited concomitant pharmacotherapy prior to randomization.
728999|NCT01862614|80 subjects will be recruited in this crossover study. Each of the subjects will receive the injection regimens at 2 separate appointments spaced at least 2 weeks apart.|
729000|NCT01862484|Recruited through advertisement in magazines and flyers posted in child psychiatry clinics|40 children were enrolled, a total of 29 were randomized. Of the remaining 11, 8 were screen failures, 3 withdrew from the study prior to randomization.
729001|NCT01862419||
729002|NCT01862328|Participants took part in the study at 6 investigative sites in the United States from 10 June 2013 to 21 May 2018.|Participants with solid tumors were enrolled to receive MLN4924 in combination with docetaxel (Arm 1), paclitaxel + carboplatin (Arm 2), or gemcitabine (Arm 3) during the Dose-escalation and maximum tolerated dose (MTD) expansion portion of this study. Participants in Lead-in cohort received MLN4924 + carboplatin only (Arm 2a).
729003|NCT01862250||Study medication was not administered for one participant
729004|NCT01862159||
729005|NCT01862133||107 primary care clinic patients were enrolled and signed informed consent statements. 2 failed to complete the patient preference dialog and study questionnaire.
729006|NCT01862029|Subjects who passed the telephone screening were invited to undergo further screening in the clinic. A total of 24 subjects were subsequently screened. Among these subjects, 14 subjects met the study's inclusion criteria.|Among the 14 subjects who met the inclusion criteria, 3 subjects withdrew participation prior to starting the study procedures due to expected possibility of noncompliance with the protocol schedule. Two additional subjects were withdrawn for new medical findings prior to their initiation of the study medication.
729007|NCT01861925||
729008|NCT01861756||
729009|NCT01861704|Patients are fitted according to their ear size and experience level. Patients with a different experience level for each ear are only counted once.|
729010|NCT01861665||
729011|NCT01861587||
729012|NCT01861574||
729013|NCT01861522||
729014|NCT01861457|Participants came from the nursing and technical staff working in the Main and Ambulatory operating rooms and patient care floors of the MUSC Hospital. Eligible to participate in the study were all healthy individuals between the ages of 18 and 70 years of age who were regular full-time employees working a minimum 10-hour workday.|Following the initial interview and after obtaining informed written consent, eligible subjects were screened to identify those who demonstrated nasal vestibular carriage of S. aureus. Subjects testing positive were invited to enroll in the study protocol within the subsequent 10 days.
729015|NCT01861301||
729016|NCT01861028||
729017|NCT01860989||
729018|NCT01860976||489 were enrolled in the study. 424 were randomized to a treatment group and received at least one dose of blinded study drug. Reasons for non-randomization were no longer met criteria (n=45), withdrawal of consent (n=15), non-compliance (n=2), adverse event (n=1), lost to follow-up (n=1), or other reasons (n=1)
729019|NCT01860950||
729020|NCT01860846||A total of 106 participants were enrolled in the study and were intended to be followed for 12 months.
729021|NCT01860807||
729022|NCT01860703|"First subject enrolled: 17 November 2012 Last subject completed: 19 December 2012
~The study was carried out at Celerion, a research facility used for conducting clinical trials."|
729023|NCT01860677||
729024|NCT01860651||
729025|NCT01860586||
729031|NCT01860079|The recruitment process began at May 2013 and finished May 2015. Acibadem University Medical Faculty, Mehmet Akif Ersoy Chest and Cardiovascular Surgery Training and Research Hospital, Dr.Siyami Ersek Chest and Cardiovascular Surgery Training and Research Hospital were the centers involved in the study.Nine-hundred subjects were enrolled.|131 patients were excluded due to unsuccesful PPCI, cardiogenic shock, signs of heart failure, stroke within a month, patients treated with thrombolytic agents for the index STEMI,chest pain recurrence, clinically significant arrhythmia >6 hours after PPCI, hypotension (<100 mmHg SBP) persisting after PPCI,inability to get informed consent.
729032|NCT01860040|did not meet recruitment goal|
729033|NCT01859988|The study was conducted at 95 study sites in 7 countries. A total of 452 participants were screened between 15 May 2013 and 10 January 2014. 380 participants were randomized and 379 were treated. 72 participants were screen failures mainly due to exclusion criteria met and inclusion criteria not met.|Randomization was stratified by disease severity (moderate Investigator's global assessment [IGA] = 3 versus severe IGA = 4 atopic dermatitis) and region (Japan versus rest of world). Assignment to arms was done centrally in 1:1:1:1:1:1 ratio for Dupilumab (300 mg qw; 300 mg q2w; 200 mg q2w; 300 mg q4w and 100 mg q4w) and Placebo.
729034|NCT01859949||"Before enrolled this study, participants with short stature due to SGA had completed the 1-year(12-month) treatment in previous study.
~Out of 62 participants who were enrolled this study, 61 participants were treated."
729035|NCT01859923|Participants took part in study at 3 investigative sites in Philippines and South Africa from July 20, 2013 to January 13, 2020. Participants received delamanid up to Day 182 in the treatment period and were followed up to Day 365 for safety and efficacy and up to Day 730 (Month 24) for treatment outcome.|Pediatric participants with a diagnosis of multidrug-resistant tuberculosis (MDR-TB) who were on therapy with an optimized background regimen (OBR) of anti-tuberculosis drugs and completed study 242-12-232 (NCT01856634) were enrolled in this extension study 242-12-233 to receive delamanid based on the participant's age and weight.
729036|NCT01859793||
729037|NCT01859741||"Phase 1b: Approximately 30 subjects were planned. A total of 27 subjects were enrolled.
~Phase 2: Approximately 135 subjects were planned to be randomized. A total of 145 subjects were enrolled/randomized.
~Total: 172 subjects were enrolled/randomized (Phase 1b and Phase 2)"
729038|NCT01859715|Recruitment was initiated in the University of Colorado Hospital ED. A convenience sample sample of ED patients were enrolled between June 2012 to January 2013. Subjects were included if they had self-reported pain or nausea identified during the initial nursing assessment. The previous 2 day medication history was obtained during their visit.|201/502 consented patients did not receive the study medication. The remaining 301 patients were allocated to either one of the opioid treatment groups or the nausea observational group based on what study medication they were prescribed and if they were able to complete serial visual analog scales for pain and nausea.
729039|NCT01859702|Subjects were recruited from one study center in Brazil.|This reporting group includes all enrolled subjects.
729040|NCT01859637|First patient in: 05-Jul-2011, last patient in: 12-Feb-2013. 2 sites (medical school and university hospital)|
729041|NCT01859611|recruitment period from April 2013 to August 2013 at two private offices|
729042|NCT01859598|From December of 2011 to June 2013 in secondary and tertiary hospitals all over China, including in-patients and out-patients.|"At the baseline stage:
~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
729043|NCT01859507||
729044|NCT01859494||
729045|NCT01859390||
729046|NCT01859325||
729047|NCT01859312|Eight adult patients with classic CAH due to 21-hydroxylase deficiency participated in this study. Four were recruited from a pool of 147 patients enrolled on a natural history study at the NIH natural history study (NCT00250159); 4 were recruited through advertisements.|
729048|NCT01859247||
729049|NCT01859195|Recruited May-Aug 2013 (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth. Volunteers complete prescreen survey. If eligible, each invited to participate in either (1) focus group or (2) individual cognitive interview (first ~20-24 for focus groups; remaining ~12-16 for interviews after FGs began).|
729050|NCT01859143||One participant randomized to receive placebo received trivalent influenza vaccine on Day 1 instead of placebo and was included in trivalent influenza vaccine group in the safety population.
729051|NCT01859078||
729052|NCT01859013||34 subjects enrolled and 30 were started on the study medication or placebo
729053|NCT01858766|Participants were enrolled at study sites in the United States. The first participant was screened on 22 April 2013. The last study visit occurred on 12 August 2014.|469 participants were screened.
729054|NCT01858701|Participants were recruited from 1 study center located in Canada.|Of the 49 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (40).
729055|NCT01858636||
729056|NCT01858558|Participants were enrolled at four sites: Johns Hopkins University, Moffitt Cancer Center, Mayo Clinic (Jacksonville) and the Blood and Marrow Transplant Group of Georgia (Northside).|Of the 102 patients randomized, one was randomized to the control group who was lost to follow-up prior to start; did not have aMILs harvested, and was not transplanted. This patient is therefore not included in this report.
729057|NCT01858545||
729058|NCT01858532||5107 participants dosed in Enrichment Period (EP); 1441 prematurely discontinued Tx or did not proceed to Double-Blind Treatment Period per criteria. 3666 participants completed EP and proceeded to Double-Blind Treatment Period, along with 2 additional participants who discontinued study drug in EP but were randomized in error.
729059|NCT01858428||Randomization. Patients who provided written informed consent but were excluded from the study due to not meeting all of the inclusion criteria or meeting one or more of the exclusion criteria were screen failures. Subjects who had unsuccessful pre-dilatation were not randomized and were to be treated per the institution's standard of care.
729060|NCT01858389||Of 41 participants enrolled in the study, 38 (16 with T790M mutation and 22 without T790M mutation) received study drug. Three of the enrolled participants without known T790M mutation did not receive treatment.
729061|NCT01858376||
729253|NCT01846624||
737849|NCT01294267|Twenty consecutive patients with scar VT underwent ablation between Sept 2010 and July 2011.|
729062|NCT01858194|"21 participants received ID numbers because they were consented. 3 patients were screen failures due to accessibility of renal vasculature and Investigator discretion.
~1 patient was a non-randomized roll- in where data was not collected."|
729063|NCT01857986||
729064|NCT01857973|A total of 8 phases: Exploratory A, Exploratory B, Phase 1, Phase 2, Phase 3, Phase 4, Phase 6 and Phase 7.|
729065|NCT01857882||
729066|NCT01857869|Out of the 64 subjects originally enrolled in the study, 1 subject was not included in the Intention-to-Treat Cohort. The design of the study included 4 epochs (see pre-assignment details).|Primary Phase (screening, vaccination [delayed fractional dose group and 0, 1, 2-month group] & challenge): Study Day (D) 217 to D245 - Follow-up: D259 to D376 - Booster (Bst) Phase (re-screening [delayed fractional dose group and 0, 1, 2-month group], vaccination & re-challange): Bst Phase Study D20 to D49 - Follow-up: Bst Phase Study D77 to D105.
729067|NCT01857713||
729068|NCT01857622||
729069|NCT01857583||
729070|NCT01857531||
729071|NCT01857362||
729072|NCT01857323||Of the 28 screened patients who were not enrolled, 12 were excluded on the basis of inclusion criteria, 7 patients for exclusion criteria, 4 patients withdrew consent,1 patient was non-compliant, and 4 patients withdrew for other reasons before the baseline visit.
729073|NCT01857310||Only the male partners in couples attempting to conceive were enrolled and assigned to treatment arms.
729074|NCT01857297|The study was non-randomized with a parallel assignment comprising of 2 groups of healthy volunteers: adults (aged 18 - 59 years) and older adults (aged 60 years or older).|None relevant
729075|NCT01857271|The patients were enrolled on 11/7/2013, 5/2014, and 9/24/2014.|The study was difficult to enroll and eventually terminated/closed.
729076|NCT01857258||
729077|NCT01857232||
729078|NCT01857206|Subjects were enrolled at a total of 34 centers in 5 countries: 18 sites in the US, 6 sites in Australia, 2 sites in New Zealand, 5 sites in the Philippines and 3 sites in Thailand.|
729079|NCT01857102|A total of 159 subjects were enrolled in the study. Of the enrolled subjects 45 did not meet the eligibility criteria and 114 subjects were dispensed a study lens. Of the dispensed subjects 10 subjects were discontinued and 94 subjects completed the study.|Of those completed 24 were excluded from the analysis due to a major protocol deviation. Of the subjects that completed all study visits without a major protocol deviation, 10 subjects were classified as neophytes and 60 as habitual contact lens users.
729080|NCT01857063||
729081|NCT01856933||
729082|NCT01856907|The study was conducted from November 2014 to September 2017. Patients were recruited from the Woman's Hospital Metabolic Clinic|. Patients were eligible for randomization if they had impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) by OGTT. Patients with diabetes or normal glucose tolerance were excluded.
729083|NCT01856790||
729084|NCT01856764|Participants took part in the study at 3 centers in Germany from 10 June 2013 to 18 March 2014.|Participants with a historical diagnosis of Atopic Dermatitis were enrolled in 1 of 2 twice daily (BID) treatment groups.
729085|NCT01856712||"9 participants who didn't receive medication were discharged from the hospital before they could get medication.
~Therefore, only 45 , out of 54 participants got the medication."
729086|NCT01856686||
729087|NCT01856673|Initial recruitment was done using referrals from key informants, community leaders, who were able to identify people affected by violence. To get more participants a snowball technique was used, participants were asked to refer others with similar problems. The identification numbers on the surveys were then randomized to one of the three arms.|710 people were assessed for eligibility, 189 people were excluded: 175 for not meeting the inclusion criteria, 11 for meeting the exclusion criteria, and 3 refused to participate.
729088|NCT01856595||
729089|NCT01856582||
729090|NCT01856569||
729091|NCT01856543||
729092|NCT01856530||Although 60 participants were enrolled in the study, 6 participants were found to be ineligible due to meeting criteria for substance dependence (n=2), a primary diagnosis of posttraumatic stress disorder (n=1), and not meeting criteria for social anxiety disorder (n=3). Therefore, only 54 participants were assigned to groups.
729093|NCT01856491||
729094|NCT01856361||
729095|NCT01856322||The normal volunteer (or control group) was not randomized to receive medication and was not considered evaluable. The control group purpose is to validate the assays and the shipping methods.
729096|NCT01856309|Participants who completed participation in studies CNTO136ARA3002 (NCT01604343) and CNTO136ARA3003 (NCT01606761) and consented to participate in extension study were enrolled in this study.|Data in the participant flow section is reported for treatment discontinuation.
729097|NCT01856270||
729098|NCT01856257|Three sites in the United States recruited and enrolled 71 participants into this trial.|
729099|NCT01856218||
729100|NCT01856114|Adult participants (age>18) with an active diagnosis of cancer were recruited between May 2014 to May 2016 from the Supportive Care Center outpatient clinic of MD Anderson Cancer Center who met the inclusion and exclusion criteria.|A total of 36 participants enrolled. 22 patients were randomized, 14 patients dropped out before randomization, 3 participants died, 4 had declining Karnofsky Performance Score/hospice, 2 participant's Morphine equivalent daily dose was no longer in range, 1 participant declined and 4 participants were no longer interested in the study.
729101|NCT01855997|Participants were enrolled from Roche completed/ongoing pegylated interferon (Peg-IFN) alfa-2a trials (MV22430/NCT00927082, ML21827/NCT00922207, ML18253/NCT01095835) or from clinical practice (GV28855/NCT01855997).|
729102|NCT01855958|Participants were recruited through a call list generated by public means of mass communication in January 2012, and announcements of research in the Department of Pain and Palliative Medicine, Hospital de Clinicas, before and during the study. Throughout the study the members of the list were selected through a telephone interview.|"Eighty-five subjects were screened. Five refused to participate, fifty-four were not enrolled for the following reasons:
~Previous experience with acupuncture. Inability to walk a certain distance. Live distant of center. Twenty-six were recruited in the study and randomized further to active(n = 13) or placebo (n = 13)groups."
729103|NCT01855945|Subjects were enrolled from 11 study centres in USA.|All enrolled subjects were included in the study.
729104|NCT01855919||The participant flow includes information on participants who completed the study. 2 participants who were assigned to receive placebo received duloxetine instead. These participants were treated as placebo in efficacy analysis and as duloxetine in safety analysis. In the participant flow, these participants are included under placebo.
729105|NCT01855828||
729106|NCT01855789||Randomized participants constituted the primary analysis population for the efficacy assessments, while all other analyses including safety assessments were performed on overall study population. An MRI sub-study was planned to evaluate joint inflammation in conjunction with other clinical signs and symptoms.
729107|NCT01855750||
729108|NCT01855425||
729109|NCT01855399||
729110|NCT01855360||
729111|NCT01855243|a known history of type 2 DM for longer than 3 months admitted to general medicine wards, age between 18 - 64 year old, treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.|
729112|NCT01855126||46 participants were enrolled into the study. These participants were randomized to begin the study with the active intervention, or the placebo intervention. After a 2 week washout period, participants were exposed to the opposite intervention.
729113|NCT01855074||
729114|NCT01854944|A Phase 1, single center, open-label trial of up to 12 enrolled participants.|Participants were at the inpatient unit in the New York State Psychiatric Institute between Days -22 and -2. Participants remained inpatient during the drug-free interval at the principal investigator's discretion.
729115|NCT01854918|Participants were enrolled at 365 study centers in 24 countries in Europe, North America, and Asia Pacific from 23 April 2013 to 31 August 2015.|Participants were randomized in a 2:1 ratio to receive evolocumab plus standard of care (SOC) or SOC alone for the first year. In years 2 and 3 all participants received evolocumab. Randomization was stratified by the parent study and parent study dose frequency (every 2 weeks [Q2W] or once monthly [QM]).
729116|NCT01854905||
729117|NCT01854879||
729118|NCT01854827||
729119|NCT01854710||
729120|NCT01854697||
729121|NCT01854658|Conducted at 140 sites throughout the United States from July 2013 - February 2015. Study participation was a maximum of 32 weeks.|A multicenter, randomized, double-blind, parallel group, chronic dosing, active- and placebo-controlled study; each participant was randomized to receive 1 of 4 possible treatments over the course of a 24-week treatment period (With a randomization of 7:6:6:3 GFF MDI, GP MDI, FF MDI and Placebo MDI)
729122|NCT01854645|Conducted at 160 sites throughout the US, Australia, and New Zealand from June 2013 - February 2015. Study participation was a maximum of 32 weeks.|Study was a multicenter, randomized, double-blind, parallel group, chronic dosing, active- and placebo-controlled study; each patient was randomized to receive 1 of 5 possible treatments over the course of a 24-week treatment period
729123|NCT01854632||
729124|NCT01854593||
729125|NCT01854528||A total of 154 participants were randomized: 6 participants did not receive at least 1 dose of study drug and were excluded from the analyses; 148 participants received at least 1 dose and were included in the intent-to-treat (ITT) population.
729126|NCT01854281|All participants were included consecutively in the Hyperbaric chamber of the Regional hospital Kladno, Kladno, Czech Republic and at Hyperbaric chamber Vyškov, Vyškov, Czech Republic, where they performed a training dive. Two dive profiles were performed (dive A and Dive B). The recruitment took part between 15/May/2013 and 15/June/2013.|No participants were excluded from the study, all enrolled participants completed the study, no transition between groups occured.
729127|NCT01854268||
729128|NCT01854242||
729129|NCT01854177||
729130|NCT01854138|Patients were consented at time of surgery scheduling up to six months in advance of surgery.|
729131|NCT01854047|The study was conducted at 201 sites in 16 countries. A total of 1532 participants were screened between June 2013 and June 2014, of which, 776 participants were randomized at 174 sites in 15 countries. 756 participants were screen failures mainly due to exclusion criteria met and inclusion criteria not met.|Randomization was stratified using blood eosinophils count (eosinophils >=0.3 Giga/L [G/L]; eosinophils 0.2 to 0.299 G/L; eosinophils<0.2 G/L) and country. Assignment was done by Interactive Voice/Web Response System (1:1:1:1:1) for Placebo and Dupilumab (300 mg every 2 weeks [q2w]; 200 mg q2w; 300 mg every 4 week [q4w] and 200 mg q4w).
729132|NCT01854034||
729133|NCT01853982|On 31 Dec 2013, enrollment was closed and the CXA-NP-11-08 study was electively terminated by the Sponsor in order to devote all resources in initiating and completing the larger registrational study (CXA-NP-11-04), which was also being conducted as part of the clinical development program for nosocomial pneumonia.|
729134|NCT01853930|98 patients were screened for eligibility between January 2014 and June 2017 at the Jesse Brown VA Medical Center in Chicago, Illinois.|33 patients were assigned to either the laboratory training group or the home-based training group. 14 were assigned to the focus group during the developmental phase (year 1) of the web-based meta program and are not included in the analysis of outcome measures. 26 did not meet the inclusion criteria and 25 declined to participate.
729135|NCT01853878|On 18 July 2014, the recruitment was stopped and the study was un-blinded. The study continued only with patients from the active treatment group who decided to stay in the study, however objective and outcomes were not assessed as planned.|Among 137 enrolled patients, 4 patients didn't receive any study product dose and hence they were not taken into account for study start.
729136|NCT01853839|Patients are included a non-completers if they did not meet the definition of the intention-to-treat (ITT) population (all patients, who received at least one dose of study medication) or if the subject attended the week 52 visit less than 26 weeks after baseline.|
729137|NCT01853774||
729138|NCT01853696||
729139|NCT01853644|The study opened to enrollment on May 23,2013 with the first patient being treated on the study on June 6, 2013. The study closed to further enrollment August 10, 2018 with 31 patients registered to the study and 30 patients treated on study.|
729140|NCT01853618||4/Arm C never opened, thus no participants were enrolled in this group.
729141|NCT01853605|The study was discontinued following product approval.|
729291|NCT01844375||
737888|NCT01291784|Recruitment period from Jan 2011 to Feb 2012 of known patients to the medical clinic.|
729142|NCT01853553|Eligible participants were enrolled at the University of Colorado Denver Anschutz Medical Campus between July 2014 and June 2016 (the trial concluded according to enrollment determined by power calculations described below).Although Grant was awarded in 2013, recruitment did not start until 2014.|Participants were excluded if they had an average serum potassium >5.5 mEq/l or any single value >6.0 mEq/l in the past 6 months, received an aldosterone antagonist in the past 6 months, and were using a potassium sparing diuretic or other medication that could contribute to hyperkalemia.
729143|NCT01853475||
729144|NCT01853462||
729145|NCT01853397||
729146|NCT01853384|Subjects were screened at 47 sites in the EU [Belgium (3), Czech Republic (8), Germany (15), Hungary (8), Poland (13)] between January 10, 2014 and November 27, 2014; sites included independent and hospital wound clinics and private practice sites.|Subjects entered a 2-week run-in; subjects whose wound radius decreased by < 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization. After completion of the treatment period, subjects entered a three-month follow up period.
729147|NCT01853371||
729148|NCT01853332||
729149|NCT01853280||The total enrollment number (those who signed informed consent) was 47, however, 3 subjects were either found ineligible or lost to follow up before they could be assigned to an arm of the study. Thus 44 subjects were randomized to the study.
729150|NCT01853254||
729151|NCT01853228||Total 17 participants were enrolled in the study. 16 participants were enrolled in Phase 1 (9 participants in Cohort 1 and 7 participants in Cohort 2). 7 participants of Cohort 2 continued to Phase 2. One additional participant was enrolled in Phase 2 of the study, making a total of 8 participants evaluable in Phase 2.
729152|NCT01853215|Healthy adults aged 21 years and older were recruited to participate in the study.|
729153|NCT01853176|Recruitment took place at Emory University Hospital - Midtown between October 2013 through November 2013.|
729154|NCT01853137|patients were recruited from those referred to the department of Orthodontics at the University of Damascus between May 2009 and June 2011.|
729155|NCT01853085||
729156|NCT01853072|Participants were recruited from 66 investigational centers located in the U.S., Latin America, and the Caribbean.|Of the 881 participants enrolled, 253 were exited as screen failures and 13 were discontinued prior to randomization. This reporting group includes all randomized participants (615).
729157|NCT01853046|Overall, 39 adult male or female participants with locally advanced and / or metastatic solid tumors were screened at 4 study centers in Canada and 4 study centers in the USA.|15 participants (38.5% of 39) were screening failures and 24 participants received treatment with regorafenib. All 15 participants who failed to meet the inclusion and / or exclusion criteria were not assigned to study
729158|NCT01852955||
729159|NCT01852942||
729160|NCT01852825|In Part 1, healthy participants aged 18-55 years were enrolled; In Part 2, participants with house dust mite (HDM)-induced allergic rhinitis or rhinoconjunctivitis, aged 18-55, were enrolled.|
729161|NCT01852812||
729162|NCT01852799||
729163|NCT01852669||
729164|NCT01852591|Participants were enrolled at Moffitt Cancer Center between March 2013 and July 2014.|
729165|NCT01852513||
729166|NCT01852383||
729167|NCT01852344||
729168|NCT01852292|Planned: 150; Analyzed: 158. Patients were randomized to receive treatment with buparlisib 100 mg daily (n=79) or placebo (n=79) in combination with paclitaxel.|158 patients randomized in a 1:1 ratio to treatment with buparlisib plus paclitaxel or placebo plus paclitaxel; stratification: number of prior lines of treatment in the recurrent/metastatic setting (1 vs.2) & region of Investigator site (North America vs. Rest of the World). In this study, Not Completed = Discontinued study treatment per Protocol
729169|NCT01852214|Between February 2013 and July 2015, a total of 61 subjects agreed to participate in the study; 11 subjects were excluded and thus a total of 50 subjects were randomized (prasugrel first n=26; ticagrelor first n=24).|11 subjects were excluded before randomization: withdrawn of consent (n=4), screen failure (n=4), unable to draw blood (n=3).
729170|NCT01852201||
729171|NCT01852175|Between December 2011 to June 2014 patients were screened at the outpatient cardiology clinics, UF Health, University of Florida, Jacksonville.|
729172|NCT01852162|This was a prospective, randomized, double-blind, placebo-controlled PD study conducted in patients with CAD on maintenance DAPT with aspirin and clopidogrel. Patients were screened at the Division of Cardiology of the University Of Florida College Of Medicine - Jacksonville from February 2012 to December 2013.|
729173|NCT01852110|Number of Participants Screened: 505 Number of Participants Randomized: 240|"Stage 1 interim analysis met the prespecified futility threshold for the primary efficacy endpoint, satisfying the clinical criteria for early trial termination (futility). As a result, the trial was terminated at Stage 1; did not proceed to Stage 2.
~In stage 1: 1 randomized participant received no study medication (MK-7622 High Dose-45 mg arm)."
729174|NCT01852084||
729175|NCT01852058|Participants who successfully completed Study 191622-120 (NCT01852045) were enrolled in this study and were followed for up to an additional 60 weeks.|Data from the participant's participation in this extension Study 191622-121 (121) were integrated with the corresponding participant's data from the preceding Study 191622-120 (120).
729176|NCT01852045||114 patients were enrolled and randomized into the study; 113 received study treatment.
729177|NCT01852032||
729178|NCT01852019||
729179|NCT01851876|One hundred thirty consecutive women undergoing 130 ICSI cycles between September 2010 to April 2011 at our clinic were included for this prospective case control study.|Following inclusion/exlusion criteria 9 women were excluded for study group, while 5 women for control group.
729180|NCT01851863||
729181|NCT01851772||
729182|NCT01851720||
729183|NCT01851655||25 subjects were consented to the study. One subject who was enrolled in the study was found to have insufficient quadriceps strength to participate in the study during baseline testing. She was withdrawn prior to randomization. 24 subjects were randomized to the study.
729538|NCT01827371|Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 17JUN2013 and 23SEP2014.|
729184|NCT01851590|In November 2013, on the basis of a newspaper advertisement, a total of 129 adult volunteers were assessed for eligibility at Vääksy Medical Center, Finland. Eligible subjects were required to provide toenail samples for screening. Inclusion criteria were a positive dermatophyte culture and a positive potassium hydroxide (KOH) stain.|Of those 129 patients screened, 48 (37%) were excluded due to negative KOH staining or cultures and 8 (6%) were excluded because onychomycosis was caused by nondermatophyte mold or yeast. At baseline, 73 (57%) patients who met the entry criteria were randomly allocated to receive 1 of 3 therapies for dermatophyte onychomycosis (3 treatment arms).
729185|NCT01851330|Participants were enrolled at a total of 59 study sites in the United States. The first participant was screened on 06 May 2013. The last participant observation occurred on 07 March 2014.|831 participants were screened.
729186|NCT01851174||
729187|NCT01850823|Randomized subjects in active treatment.|
729188|NCT01850745||
729189|NCT01850641||
729190|NCT01850615|The trial was conducted at 51 sites in 6 countries as follows: Argentina: 4 sites; India: 8 sites; Mexico: 3 sites; Romania: 5 sites; Slovenia: 4 sites; United States: 27 sites.|A total of 555 subjects were screened, of which 232 subjects were screening failures and 323 subjects were enrolled and entered the run-in (pre-assignment) period. Of those, 87 subjects were run-in failures. Hence, 236 subjects were randomized to the 18 weeks of treatment period.
729191|NCT01850602||
729192|NCT01850589||
729193|NCT01850550||
729194|NCT01850485||
729195|NCT01850446||
729196|NCT01850394|The patients, who planned to undergo primary total knee replacement, were recruited from medical clinics before setting the operative schedule between 2009 and 2010.|Seventeen patients were excluded that including refusal to participate (4 patients), serum creatinine more than 2.0 mg% (4 patients), rheumatoid arthritis (4 patients), abnormal coagulogram (3 patients), and history of stroke (2 patients)
729197|NCT01850030||1070 subjects were enrolled in the study and 1031 subjects were randomized
729198|NCT01850004||
729199|NCT01849848||
729200|NCT01849770|The first subject in the study was enrolled July 23, 2013. Subjects were recruited and seen at Amyotrophic Lateral Sclerosis (ALS) clinics at 10 sites across the United States (U.S.).|Seventy-five (75) subjects signed the consent form and were considered enrolled in the study. Fifteen (15) subjects did not meet eligibility criteria and were considered screen failures. Sixty (60) subjects were randomized to one of three treatment arms. One (1) subject was randomized to the 900mg group but never started study drug.
729201|NCT01849692|Subjects were recruited from 12 investigational centers located in the US, Australia, and the Dominican Republic.|Of the 107 enrolled, 55 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized participants (52).
729202|NCT01849588|Participants were enrolled between December 2013 and December 2015|
729203|NCT01849575|"Information and collection informed consent: April 11 2012- June 1 2016 at the occasion of participation in the Västerbotten Intervention Program, Sweden, an ongoing CVD prevention program targeting residents at ages 40, 50 and 60 years
~Inclusion in the trial: April 29 2013-June 7 2016 at the Clinical research center, Umea University Hospital"|
729204|NCT01849562|Participants were recruited from 7 sites in the US and 1 site in Canada between May 7, 2013 and April 4, 2014.|Participants were screened within 4 weeks (-28 to -1) before administration of study drug. Subjects who meet all eligibility criteria were instructed to arrive at the study center on baseline day.
729205|NCT01849497|"Eligible patients were men and women ≥ 18 and ≤ 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL, fasting triglycerides ≤ 400 mg/dL and on a stable dose of a statin with or without ezetimibe for at least 4 weeks.
~The first patient enrolled on 18 April 2013 and last patient enrolled on 05 August 2013."|Randomization was stratified on the basis of screening LDL-C concentration (< 130 mg/dL [3.4 mmol/L] or ≥ 130 mg/dL). Participants were trained by study site staff to prepare and self-administer the study drug.
729206|NCT01849458||
729207|NCT01849419|From July 2010-June 2012, healthy male and non-pregnant female occasional ecstasy users, aged between 18 and 35 years, were recruited through posters, print and internet advertisements and word-of-mouth referrals. All recruitment and study procedures were conducted in a medical laboratory setting.|Participants were excluded for one of or more of the following reasons: history of adverse effects from ecstasy; current Axis I disorders; medical conditions precluding participation including high blood pressure, abnormal EKG, first degree relatives with heart disease; pregnancy or lactation (females), and significant nasal or sinus condition.
729208|NCT01849289|"The trial was conducted at 68 sites in six countries as follows:
~Brazil: 3 sites; Canada: 7 sites; China: 37 sites; South Africa: 4 sites; Ukraine: 6 sites; United States: 11 sites."|The subjects discontinued their current Oral Antidiabetic drug (OAD) treatment at Visit 2 (randomisation visit) except for metformin, before starting the treatment with trial drugs.
729209|NCT01849276|The study opened for accrual July 29, 2013 with an accrual goal of between 19 to 28 participants in a 3 + 3 dose escalation design to find the maximum tolerated dose of metformin in combination with cytarabine. The study was closed permanently on January 21 2016 due to slow accrual.|
729210|NCT01849263||Forty-one patients were enrolled to this study. One patient cancelled prior to beginning protocol treatment and was excluded from all analyses.
729211|NCT01849172||
729212|NCT01849068||
729213|NCT01849055||
729214|NCT01848990||
729215|NCT01848977||
729216|NCT01848938|We recruited community-dwelling women, from March 2013 to October 2014, through our website. Interested women filled out a questionnaire to determine whether they met the study criteria. Eligible women received a letter with informed consent and a 2-day leakage diary, and after returning this they also answered a web-based questionnaire.|Randomisation was performed by concealing the allocations in sequentially numbered, opaque, sealed envelopes. An independent administrator generated the allocation sequence and prepared 130 envelopes. The study coordinator opened one envelope for each participant and assigned an e-mail, with materials for the corresponding study group.
729217|NCT01848899||
729218|NCT01848847||
729626|NCT01821729||
729627|NCT01821625||
738150|NCT01277211||Of the 983 participants randomized, 946 received treatment and 37 discontinued prior to receiving treatment.
729219|NCT01848834||This results disclosure is based on a data cutoff date of 26 April 2016 for Cohorts A and D, and a data cutoff date of 01 Sep 2015 for Cohorts B, B2 and C. As of the data cutoff dates, 33 participants were on treatment in the study. One additional participant was enrolled in Cohort B, but did not receive any study treatment.
729220|NCT01848821||
729221|NCT01848756||
729222|NCT01848483|Recruitment started in June 2014 at Emory University|
729223|NCT01848457||
729224|NCT01848366||
729225|NCT01848353|Recruitment for the exercise intervention was July 2013 - April 2016. Recruitment for the reference group was July 2015 - April 2017. All participants were were recruited from medical clinics, schools, or community settings in Southeast Oklahoma.|142 people enrolled (completed informed consent). During screening, 4 OW/Ob and 8 NW people were disqualified, and 5 OW/Ob and 5 NW people voluntarily withdrew. Baseline data were thus available for 120 people. After baseline testing was complete, 81 OW/Ob participants were randomly assigned to either standard pay or incentive group for Phase 1.
729226|NCT01848288|Participants were recruited from 2 investigative sites located in the US and 1 investigative site located in Spain.|Of the 112 enrolled, 12 participants were exited as screen failures prior to randomization. One participant was randomized twice in error. This reporting group includes all randomized participants (100).
729227|NCT01848210|Participants took part in the study at 8 investigative sites in Brazil from 28 May 2013 to 29 September 2015.|Participants with a diagnosis of chronic venous insufficiency were enrolled equally in 1 of 2 treatment groups, three times a day coumarin 30 mg and troxerutin 180 mg fixed-dose combination tablets or matching placebo.
729228|NCT01848184||
729229|NCT01848158||
729230|NCT01848145|Between July 2013 and June 2015, 34 subjects with at least one prior therapy for Chronic Lymphocytic Leukemia (CLL) were enrolled at 5 investigational sites in the U.S.|
729231|NCT01848067||
729232|NCT01848054||A total of 313 patients were enrolled. Three patients who were randomized did not receive study drug, making the participant flow 310.
729233|NCT01847885|Recruitment began in March 2013 and was concluded in May 2015. Subjects were screened for the study from the available pool of candidates who presented to the Investigators with shoulder pain following stroke.|Following informed consent and enrollment in the study, subjects were given a 7-day diary to complete at home. At the following visit, subjects were randomized once all eligibility criteria were met. Therefore it was possible for subjects to no longer meet eligibility criteria or drop out after enrollment, but prior to being randomized.
729234|NCT01847638||
729235|NCT01847560|This study used a cohort design with descriptive analyses, using data from January 2009 through September 2015. The study was conducted within two US-based longitudinal healthcare claims databases (MarketScan and UnitedHealth Research Database).|The data source for this project was a combination of claims data from UnitedHealth, a commercial health insurer, and MarketScan, a research claims database from commercial employer-sponsored health plans both of which provide comprehensive medical coverage for members with active policies.
729236|NCT01847547|This is an observational study. Patients were not actively recruited in this study. The data source was the UnitedHealth database.|11882 patients fulfilled the in- and ex-clusion criteria. Only 5982 patients remained after matching on the Propensity Score.
729237|NCT01847469||
729238|NCT01847443|Potential participants were recruited at a single site in the UK.|A total of 160 participants were screened for this study, of which 84 participants were randomized. Seventy seven participants completed the study.
729239|NCT01847430||One subject from the total number of 303 subjects enrolled did not qualify to start the study due to a protocol violation.
729240|NCT01847313|All subjects were recruited from St Vincent's University Hospital, Dublin, Ireland|
729241|NCT01847274|First patient enrolled 26Aug 2013. Study is ongoing; Data cutoff date of 30May2016 There were 7 patients who were randomized, but did not receive treatment (2 in gBRCA Niraparib; 3 in Non-gBRCA Niraparib and 2 in Non-gBRCA Placebo groups).|
729242|NCT01847209|The recruitment for this study was completed in the medical clinic and started in April 2013 and included in September 2014.|
729243|NCT01847196||For this study, enrollment was defined as the time of consent. There was a possibility that a consented subject could still become ineligible prior to Angel® Catheter placement. One (1) of the six (6) enrolled (i.e. consented) subjects became ineligible prior to Angel® Catheter placement, and did not go on to start the study.
729244|NCT01847131|Eligible patients from medical clinic were instructed to record the severity of nasal congestion 3 days prior to randomization. The severity of nasal congestion was recorded on a 0 to 3 scale (0 = no symptom and 3 = severe symptom). Participants who had nasal congestion score of 1 or greater were recruited for randomization.|Exclusion if patients with a history suggestive of cardiovascular, hepatic or renal diseases, pregnant or lactating women, taking oral or nasal decongestant within 7 days, treated with immunotherapy, patients with nasal polyp or significant deviated nasal septum and patient with a history of upper respiratory tract infection within 14 days.
729245|NCT01847092||
729246|NCT01847027||
729247|NCT01847014|All sites activated on the SYMPHONY AC-055-401 clinical trial were invited to participate in this open-label extension study. Due to meeting the study closure milestone, defined as the marketing of Opsumit on 18 OCT 2013, only two sites received activation. Recruitment occurred between Quarter 2 2013 and Quarter 3 2015.|Subjects who completed the sixteen week treatment of macitentan on the SYMPHONY AC-055-401 clinical trial were eligible to enter this open-label extension study.
729248|NCT01847001||
729249|NCT01846871||
729250|NCT01846741|Eligible subjects were at least 12 years old, good general health suitable for VNS implant with refractory (drug-resistant) partial onset seizures and a history of ictal tachycardia, defined as heart rate above 100 beats per minute (bpm) during a seizure and at least a 55% increase or 35 bpm increase from baseline.|A total of (22) subjects were screened; (2) did not meet study criteria, (20) were treated/implanted with the AspireSR® VNS Therapy® System.
729251|NCT01846728|Participants were recruited through advertisements posted on the Anschutz Medical Campus and distributed through the campus email system. 12 women consented to participate in the study (consent was obtained prior to screening and orientation). After the screening and orientation process, 6 elected to continue, and 6 elected not to continue|
729252|NCT01846702||
729254|NCT01846611||Total 581 participants were enrolled. Out of which 5 participants who were enrolled at the time of study termination were not assigned to any treatment group. Therefore, these 5 participants were not considered as randomized participants and excluded from result analysis.
729255|NCT01846507||Baseline menses (no treatment) followed by 3 menses using tranexamic acid.
729256|NCT01846494|113 participants recruited from 10 May 2013 (first participant first visit) to 10 Mar 2018 (last participant last visit) at 15 clinical sites. One participant was followed by the Duke Clinical Research Institute (DCRI) call center.|
729257|NCT01846455||
729258|NCT01846442|A total of 403 subjects were screened at 8 medical/research sites located in the US (2 centers) and Canada (6 centers) and 218 subjects were randomized. The first subject first visit was on 28-JUN-2007 and the last subject last visit was on 23-MAY-2008.|
729259|NCT01846416||Overall 201 participants were screened for clinical eligibility, out of which 63 participants were screen failures, and hence 138 participants were enrolled, and 137 participants received treatment.
729260|NCT01846299|A total of 181 participants were enrolled. Of these, 178 adults were randomized in a 2:1 ratio and considered for analysis. The 3 adolescent participants, non-randomized, received open-label treatment and were not included in the analyses. Therefore, the number enrolled = 181 differs from the number randomized = 178 in the participant flow.|
729261|NCT01846273|This study was conducted in the following jurisdictions: Japan (25 centers), Malaysia (2 centers), Singapore (4 centers), Hong Kong (2 centers), Taiwan (6 centers), Thailand (3 centers) and Korea (5 centers).|The enrollment number in the protocol section reflects the number of participants treated (321). The total number in the participant flow and baseline characteristics sections reflects the number of participants randomized (322).
729262|NCT01846221||
729263|NCT01846208|Study recruitment began in July 2013 and accrual closed in August 2015.|
729264|NCT01846104||
729265|NCT01846039||
729266|NCT01845974|all patients scheduled for atrial fibrillation ablation referred to study coordinator. Non qualifying reasons include: Clot on TEE;Persistant AFib despite previous treatments;Combo treatment needed for both atrial fibrillation and flutter; Declined participation:Afib the morning of procedure;ICD;Rhythm other than Sinus Rhythm|
729267|NCT01845831|Participants were recruited between August 23, 2013 and July 27, 2015.|Of the 292 subjects who consented for participation, 279 began the inpatient study phase. Two hundred and fifty-three participants began the outpatient study phase.
729268|NCT01845818||
729269|NCT01845792||
729270|NCT01845636||
729271|NCT01845220||
729272|NCT01845155|The trial was announced by press releases in German leading to self-admittance to the Heidelberg Out-patient Center for Tinnitus. It was offered to patients by ENT-doctors in own practice nationwide and to patients attending the ENT-clinic of the university hospital Heidelberg. Recruitment took place between March 2006 and February 2013.|complete audiometric and psychological profile (exclusion of 10 patients due to incomplete data)
729273|NCT01845103||
729274|NCT01845077||
729275|NCT01845025|Following the decision to stop further enrollment into the study, 1121 patients had been screened, of whom 825 were randomized. Of the 820 patients randomized and treated and part of Intent To Treat (ITT analysis) 5 patients were randomized but were excluded from the ITT analyses as they did not take study medication.|827 actual in the protocol section came from the IRT because 2 patients were randomized twice but only counted once.
729276|NCT01844986|Patient enrolment was from 26 August 2013 to 13 February 2015. Enrolment was at 197 centres in 15 countries. 391 patients were randomized in the Global study. A further 59 were randomized to a separate China cohort (450 randomised in total). The Global study was used for the hypotheses testing of the study.|It was planned that approximately 344 women with BRCA mutated ovarian cancer patients who are in clinical complete or partial response following first line platinum based chemotherapy were to receive olaparib 300 mg bd or matching placebo in a 2:1 ratio.
729277|NCT01844895|Autoinjector Substudy initiated April 2013; completed July 2014. Those participating in the long term main (parent) study IM101-174 who received weekly open-label SC 125mg abatacept injections via prefilled syringe for at least 3 months and who did not participate in a previous device substudy were eligible to enroll in the autoinjector substudy.|
729278|NCT01844856||
729279|NCT01844830||
729280|NCT01844817|Between September 2013 and December 2014, 132 subjhects with untreated metastatic pancreatic cancer were enrolled in the trial from 11 U.S. investigational sites.|Subjects were enrolled and randomized in a 1:1 ratio (66 per Arm) to receive a combination of gemcitabine and nab-paclitaxel plus either OGX-427 (apatorsen) or a placebo.
729281|NCT01844778||Each participant was assigned to 1 of 3 treatment arms, TIS/TIP, COLI/TIP, or TIP/TIP with the first treatment cycle based on the participant's usual antibiotic treatment. Then all participants were crossed-over to receive TIP for the second cycle of treatment.
729282|NCT01844765|A minimum of 50 pediatric patients were to be enrolled in the study. 34 imatinib/dasatinib resistant/intolerant CML-CP patients and 25 newly diagnosed CML-CP patients were enrolled in the study. In the imatinib/dasatinib resistant/intolerant patient population, 1 patient did not receive study drug and was excluded from all analyses.|
729283|NCT01844700||14 subjects were consented to the study and received screening, 7 subjects did not meet the eligibility criteria to the study and were therefore not randomized to the study
729284|NCT01844687||
729285|NCT01844583|Participants took part in the study at 6 investigative sites in the United States from 25 June 2013 to 06 September 2016. Data cut-off for primary analysis was 04 August 2014.|Participants with a diagnosis of advanced solid tumors or lymphomas were enrolled to receive alisertib 50 mg tablets, orally along with esomeprazole 40 mg, delayed release capsule once daily and alisertib 50 mg along with rifampin 600 mg capsule.
729286|NCT01844531||
729287|NCT01844518||187 participants (ages 6 to 17) were enrolled and 173 were treated during the short-term (ST) period. Reasons for not being treated include 5 withdrew consent, 1 was non-compliant and 8 no longer met the study criteria. 164 completed the ST period. 157 entered the long-term extension (LTE) period. 149 participants are in the LTE on-going study.
729288|NCT01844505||1296 participants were enrolled; 945 were randomized to a treatment group; 937 received at least one dose of study drug.
729289|NCT01844479||
729290|NCT01844388||
729292|NCT01844284|The target sample size was approximately 400 subjects (266 in the Absorb arm and 134 in the XIENCE arm) enrolled in approximately 40 investigational sites in Japan. First subject was enrolled on April 27, 2013 and the last subject completed 5-year follow-up on January 16, 2019.|
729293|NCT01844206||
729294|NCT01844115||
729295|NCT01843972||
729296|NCT01843933||
729297|NCT01843920||
729298|NCT01843842||
729299|NCT01843803||
729300|NCT01843777||Three subjects were consented but not enrolled into the study because they did not meet the inclusion criteria. One subject withdrew from the study after enrollment but prior to randomization.
729301|NCT01843751||Initially 24 participants consented,but 3 did not receive intervention or provide data, so only 21 participants were analyzed out of 24 enrolled.
729302|NCT01843673||
729303|NCT01843660||
729304|NCT01843621|Seven Thai children from the Dengue-03 study will be invited to participate|
729305|NCT01843465|All patients were recruited at Clinique Pasteur. During the inclusion period, 36 underwent cryoballoon ablation of atrial fibrillation using the Achieve 20mm catheter for real-time documentation of PV potentials.|2 patients were not considered eligible due to previous atrial fibrillation ablation.
729306|NCT01843374||"A total of 658 patients were screened, 87 patients were excluded from randomisation and 571 patients were randomised:
~Of the 78 excluded, 66 did not meet inclusion/exclusion criteria; 19 withdrew consent and 2 were excluded for other reasons."
729307|NCT01843348||
729308|NCT01843205||
729309|NCT01843192|Individuals undergoing VATS lobectomy for suspected or confirmed Non-small Cell Lung Cancer, or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of Care, and who meet study entry criteria, were enrolled in this study.|There was no assignment to treatment group given that this is a single arm study wherein the same device was used on all subjects. Results are presented for the overall cohort as well as by the individual procedure performed - lobectomy, wedge resection, or wedge resection with lobectomy.
729310|NCT01843062|Study conducted between 27 Aug 2013 and 06 Mar 2019. 42 centres in 8 countries randomised patients in the study. A primary analysis was performed for the 18 months post-radioactive iodine (RAI) treatment period with a data cut-off of 18 May 2018. All primary and secondary outcome measures were reported at the time of the primary analysis.|Eligible patients with differentiated thyroid cancer at high risk of primary treatment failure were randomly assigned (ratio 2:1), to receive selumetinib in combination with adjuvant RAI therapy or placebo and adjuvant RAI therapy for a period of approximately 5 weeks.
729311|NCT01842958||
729312|NCT01842906||
729313|NCT01842841|Participants from study HGT-GCB-087 (NCT01614574) were enrolled in this study except one participant who was not enrolled due to personal reasons.|
729314|NCT01842789||
729315|NCT01842646|Recruitment began in August 2013 and participants were enrolled at Moffitt Cancer Center between September 2013 and September 2015.|
729316|NCT01842633|Participants were recruited at clinical sites in the United States.|365 participants were enrolled in the study out of which 165 participants were randomized in the study. 200 participants were not randomized for the following reasons: 165 were screening failure, 3 due to Adverse Events (AEs), 7 were lost to follow-up, 19 withdrawals by participant, and 6 due to other reasons.
729317|NCT01842620|This study was conducted from 13 Mar 2013 to 04 May 2013 at single center in Argentina.|A total of 25 participants were enrolled in the study; however, one participant withdrew from the study before completing the two study periods. The remaining 24 participants were considered for the pharmacokinetic (PK) analyses.
729318|NCT01842607|This study was an extension of MEA115588 (NCT01691521) and MEA115575 (NCT01691508). Participants who completed the prior studies were offered to enroll in this study. Assessments that were captured as part of exit visit for MEA115588 and MEA115575 served as Baseline visit for this study.|651 participants who completed the study MEA115588 or MEA115575 were enrolled in this study. Participants meeting all the inclusion criteria and none of the exclusion criteria received their first mepolizumab dose at Visit 1 and continued to receive mepolizumab subcutaneous (SC) injections approximately every 4 weeks for 12 months.
729319|NCT01842594|Subjects were enrolled between August 2012 and June 2014 at Department of Radiation Therapy and Oncology, Shin Kong Wu Ho-Su Memorial Hospital.|
729320|NCT01842581||A total of 222 participants with cirrhosis and in remission from demonstrated hepatic encephalopathy (HE) were enrolled and randomized in a 1:1 ratio to either Rifaximin 550 mg BID or Rifaximin 550 mg BID + Lactulose treatment arm.
729321|NCT01842464|44 patients with significant Pelvic Organ Prolapse requiring mesh reconstruction during 2011-2012|The study patients were retrieved out of the operated patients population during the study period.
729322|NCT01842438||
729323|NCT01842334||9 out of the 21 subject screened did not qualify for randomization. 6 of the subjects were no longer interested in participating after the screening visit, 2 did not return repeated phone calls by study staff and 1 subject did not qualify due to being on probation.
729324|NCT01842308||
729325|NCT01841970||
729326|NCT01841931||
729327|NCT01841762|Seventy-nine sites recruited subjects to reach a total of 284 total enrolled, with 335 subjects entered screening. Institution-based and community clinic sites, with pulmonary arterial hypertension expertise, were included in the study. The first subject, first visit occurred on 25 APR 2013 and last subject, last visit occurred on 05 OCT 2015|Screen failures total 51 subjects. Six subjects were removed from the full analysis set of 284 due to exclusion. The per protocol set includes 278 subjects total (97.9% of enrollment), utilized for all validation and exploratory ePRO analyses. The safety set, encompassing all enrolled subjects receiving study treatment, includes 284 subjects.
729328|NCT01841736||
729329|NCT01841697||
729330|NCT01841632||
729331|NCT01841619||
729332|NCT01841606||
729333|NCT01841593||
729334|NCT01841567||
729534|NCT01827670|Participants were recruited at the clinical site.|Participants with a minimum of two non-adjacent sensitive teeth (incisors, canines or pre-molars) with a Schiff Sensitivity Score(following an air blast stimulus) of ≥ 2 and a tactile threshold (Yeaple probe) of ≤ 20 grams (g) force were enrolled in this study.
729335|NCT01841554||Of 62 patients originally enrolled, 1 excluded from full analysis data set (N=61) but included in safety analysis data set (N=62). Patient had severe MR, right heart failure (RHF), and tricuspid regurgitation (TR); determined to be a significant deviation from intended use of device. Study protocol amended to exclude severe RHF and TR.
729336|NCT01841281|54 subjects consented and enrolled for the trial, but n=50 were randomized as n=4 participants declined to participate.|Participants were assigned to low or high exhaled nitric oxide groups based on their levels at time of Visit 1.
729337|NCT01841216||
729338|NCT01841073||
729339|NCT01841021|One participant was enrolled in June 2015 at Moffitt Cancer Center. Soon after the accrual of this one participant, the sponsor terminated their support of the project.|
729340|NCT01840943||Out of 32 participants screened, 26 were randomized to study treatment.
729341|NCT01840722|Adult women were randomly selected from three rural jails in Appalachia, screened, and interviewed face-to-face in a private room in the jail. Study eligibility included: 1) moderate risk of substance abuse based on the NIDA-ASSIST score of 4+ for any drug; 2) residing in Appalachia before incarceration; and 3) willingness to participate.|Of the 688 screened, 248 (36%) did not meet eligibility criteria due to: not being released during time frame (n=203), not engaging in risky sexual practices (n=15), not being from Appalachian (n=21), and not meeting NM-ASSIST criteria (n=9). 440 (64%) met criteria, but 40 were released prior to completing the baseline. The final N=400.
729342|NCT01840605||
729343|NCT01840410||A total of 183 participants were enrolled. Of these, 178 adults were randomized in a 2:1 ratio and considered for analysis. There were 5 adolescent participants, non-randomized, who received open-label treatment and were not included in the analyses. Therefore, the number enrolled = 183 differs from the participant flow number started = 178.
729344|NCT01840345||
729345|NCT01840319|Participants who completed the initial study 3074A1-4448 (B1811030) (NCT00799591) and whose death were not reported at the end of initial study were eligible to participate in the study.|Out of 156 participants who were enrolled in initial study 3074A1-4448 (B1811030) (NCT00799591), 138 participants did not have dates of death, hence, survival data was retrospectively collected for these participants in this study. All data were then combined with the existing survival data for an updated survival analysis.
729346|NCT01840228||
729347|NCT01840163||
729348|NCT01840072||
729349|NCT01839916||
729350|NCT01839708||
729351|NCT01839695||
729352|NCT01839656||Of the 23 participants screened, 2 were screening failures. A total of 21 participants enrolled; 1 was withdrawn from the study due to respiratory failure prior to receiving the first dose of study treatment. Twenty participants received at least 1 dose of study treatment and were included in the efficacy, safety, and PK analyses.
729353|NCT01839604|The first patient entered the study on 03 May 2013, and the last patient last visit before the DCO was 31 December 2014. The DCO date was 05 January 2015.|Note that 39 patients is the number of patients who were actually assigned to treatment out of the total enrolled. The ecpansion phase consisted of the 3mg/kg group only.
729354|NCT01839487|Study had 2 run-in phases (for evaluating safety and tolerability of PAG [PEGPH20 + Nab-paclitaxel {NAB} + Gemcitabine {GEM}] treatment), one for each formulation of PEGPH20 (original and new formulations [injectable solution containing 3.5 milligrams/milliliter {mg/mL} and 0.3 mg/mL PEGPH20, respectively]), and a Phase 2 (Stage 1 and 2) portion.|Study was on partial clinical hold from April to July 2014 due to higher incidence of thromboembolic events (TE) in PAG arm participants. Study enrollment (Stage 2) was reopened in June 2014 after excluding participants with high-risk of TE and adding enoxanparin prophylasis. Participants of PAG and AG arm both received AG during clinical hold.
729355|NCT01839396|Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and randomization for study endpoints|Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and randomization for study endpoints
729356|NCT01839318|Participants were recruited from 1 study center located in Germany.|Of the 30 enrolled, 2 participants discontinued before product was dispensed. This reporting group includes all participants exposed to the study product (28). In this 3-treatment, 6-sequence crossover study, each participant received all 3 products in randomized order and used 1 product at a time for a duration of 12 hours.
729357|NCT01839279||
729358|NCT01839188|The study enrolled N=385 infant participants previously vaccinated with only 1 dose of monovalent Hepatitis B vaccine, within 3 days after birth, outside of study context.|Participants progressed through the study as a single group, with all participants receiving the same mixed-schedule vaccination series. Vaccination (V1) was administered on Study Day 0 (2 months of age), with V2 (4 months of age) and V3 (6 months of age) administered at Study Months 2 and 4, respectively.
729359|NCT01839110||
729360|NCT01839058||
729361|NCT01838980||
729362|NCT01838941||
729363|NCT01838876||Rollover participants from Study RGH-MD-72 [NCT01715805] were eligible for this study if they had completed either the double-blind treatment or the continued-treatment periods. New patients were eligible if they had an ongoing inadequate response to a protocol-allowed antidepressant therapy (ADT).
729364|NCT01838863||The enrollment and randomization occurred almost simultaneously. Once the paramedics determined the patient to be eligible, the cooler was opened and the randomization was done based on the cooler content: cooler with plasma randomized the patient to the experimental and cooler with frozen water randomized the patient to the control group.
729365|NCT01838785||
729366|NCT01838694||
729367|NCT01838681|1986 patients were enrolled; 1982 received open-label ADT plus double-blind placebo in the 8-week Period A. In the 24-week Period B, 886 patients were randomised and 885 were treated with open-label ADT plus double-blind brexpiprazole or placebo. Non-randomised patients continued in Period A+ and received open-label ADT plus double-blind placebo.|
729368|NCT01838655|Five participants with OCA1B will be enrolled initially. However, up to an additional three participants may be enrolled to account for participants who withdraw from the study for any reason before the Month 12 visit.|
729369|NCT01838642||No participants were enrolled in the RET mutation negative group; study closed prematurely.
729750|NCT01812681||
729370|NCT01838616|The trial started on 22 Mar 2013 with the enrollment of the first participant and was completed on 28 Jan 2014 when the last subject completed the last follow-up examination according to the protocol.|"367 participants signed informed consent. 89 participants did not meet the inclusion/exclusion criteria, 16 participants withdrew and 4 participants left the trial for other reasons.
~Participants randomized to oxycodone/naloxone PR could be switched to tapentadol PR treatment in the pick-up arm of the trial."
729371|NCT01838590|Participants were enrolled at a total of 3 study sites in Egypt. The first participant was screened on 30 March 2013. The last study visit occurred on 04 August 2014.|141 participants were screened.
729372|NCT01838499|221 subjects enrolled, 109 randomised. Enrolment for ERF based on info databased, as per programmed outputs and the CSR - the criteria being to have provided written consent. 3 additional patients were accounted for in the PRF. M and F subjects with moderate to severe HS were randomised to MEDI8968 or Placebo. 29 centres in the US involved.|Randomisation to treatment was stratified by PGA score on the day of randomisation (Stratum 1=PGA score of 3; Stratum 2=PGA score of 4 or 5).
729373|NCT01838447||
729374|NCT01838304||
729375|NCT01838226||
729376|NCT01838213|Patients with any type of CA-UTI caused by ESBL-producing or non-ESBL producing E. coli and receiving empirical treatment were included in the study. Data on treatment outcome were obtained and possible associations between outcome and mecillinam treatment, ESBL-status and other variables were investigated.|
729377|NCT01838200||The study was terminated early due to slow enrollment; thus, Cohort 1 Group 3 and Cohort 2 were not enrolled.
729378|NCT01838044|This study was conducted at 28 sites across 7 countries. From a total of 232 participants screened, 180 were randomized into Period 1 and 166 entered into Period 2.|Participants who completed a minimum of 4 days per week of daily diaries during the 7 days preceding the baseline visit and had a mean weekly pain score >= 4 at the end of screening were randomized to either Arm A or Arm B.
729379|NCT01837966|Patients were recruited from the out-patient surgical unit of New York University (NYU) Langone Medical Center from January 18 - June 11, 2013. Only female patients having breast surgery were approached.|Only patients who had any allergy or sensitivity to the oils or had allergies were excluded.
729380|NCT01837823|Recruitment began in July 2013, with enrollment from August 2013 to February 2015, 91 patients with multivessel CAD, who underwent percutaneous coronary intervention (PCI) for a culprit lesion followed by OCT and NIRS/IVUS imaging of an obstructive NCL were enrolled.|
729381|NCT01837797|129 patients were enrolled in the study and 128 patients received open-label treatment with one of six commercially available antidepressant antidepressant treatments (ADT) together with double-blind study treatment. Only 15 patients were randomized to Period 2 before the study was terminated; 47 patients entered Period 3.|
729382|NCT01837719||A total of 149 patients were enrolled and 64 randomized to 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC), with a 7-day washout period between treatments. Approximately 32 were to be discharged after Period 4, based on treatment sequence. Those remaining were to continue to and be discharged at end of Period 5.
729383|NCT01837680|Women with gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) who entered the Diabetes in Pregnancy Program were recruited from March 2013 through October 2014|
729384|NCT01837654|Ninety three consecutive patients underwent multichannel urodynamic study. All patients were referred for urodynamics in order to evaluate lower urinary tract symptoms. Twenty seven were diagnosed with DO. Twenty two patients were included in the study and comprised the study cohort. Five patients were excluded due to physical disability.|Twenty seven patients were diagnosed with DO. Twenty two patients were included in the study and comprised the study cohort. Five patients were excluded due to physical disability.
729385|NCT01837550|2013-2014; Borås Hospital, Sweden; Alingsås Hospital, Sweden; Skene Hospital, Sweden.|Participants who registered at the website and completed the screening form (n=108) were called for an interview to assess their eligibility; 104 informed an agreement to participate in the study. 14 of them did not fulfill the criteria for the Hearing Handicap Inventory for the Elderly, and 16 chose not to fill out the requested questionnaires.
729386|NCT01837537||
729387|NCT01837524||
729388|NCT01837069||
729389|NCT01836809||
729390|NCT01836549||
729391|NCT01836523|The trial was conducted at 177 sites in 17 countries: Argentina: 6, Australia: 5, Belgium: 4, Canada: 14, Germany: 8, Finland: 6, France: 13, United Kingdom: 10, Ireland: 5, Israel: 6, Netherlands: 6, Norway: 5, Poland: 5, Russia: 5, Sweden: 4, Ukraine: 5, United States: 70|Eligible subjects were randomised in a 3:3:3:1:1:1 manner to receive liraglutide (0.6 mg, 1.2 mg or 1.8 mg) or placebo (0.1 mL, 0.2 mL or 0.3 mL), both adjunct to insulin treatment.
729392|NCT01836471||Total of 939 subjects were screened, 679 entered the inhaled corticosteroid (ICS) tapering run-in, 345 subjects were randomized; eleven randomized subjects discontinued the study prior to start of study drug. Patient disposition and baseline characteristics were presented for 334 subjects (received study drug)
729393|NCT01836458||
729394|NCT01836445|From May 2013 to December 2015, 901 participants were recruited and enrolled from (1) community-based HIV testing organizations in Atlanta, Chicago, and New York; (2) local health department clinics in Chicago; (3) street outreach in Atlanta, Chicago, and New York; and (4) local and national advertising.|Participants were randomized after completing a baseline assessment and STI testing.
729395|NCT01836276||
729396|NCT01836198||This study was conducted in 2 parts at a single center as an inpatient and outpatient study. Part A was an open-label, fixed sequence, 2-period, 2-cohort study. Part B was an open-label, 1-period study. Participants who completed Part A were eligible to participate in Part B.
729397|NCT01836185||
729398|NCT01836133||
729399|NCT01836042||
729400|NCT01836029||
729401|NCT01835912||
729402|NCT01835899||This study of multiple doses over 14 days was randomised, double-blind, and placebo-controlled within dose groups.
729403|NCT01835756||
729404|NCT01835743||
729405|NCT01835626||
729535|NCT01827592||The trial included a 4-week Screening Period and a 2-week Pretreatment Period prior to patient randomization to a 26-week Treatment Period. A total of 909 patients were screened in the trial and of these 533 patients were excluded due to screening failure.
729406|NCT01835587|The multicenter study was conducted in the United States and the United Kingdom. Participants were enrolled at 5 study sites.|Participants with a confirmed diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who received an allogeneic hematopoietic stem cell transplant (HSCT) were eligible to participate and begin study drug between 42 and 84 days post HSCT. One participant was enrolled into the study but discontinued before being treated.
729407|NCT01835548||
729408|NCT01835496||
729409|NCT01835470|23 participants were enrolled and 20 participants were treated. Reason for non-treatment was that 3 participants no longer met study criteria.|
729410|NCT01835431|"The trial was conducted at 63 sites in 14 countries as follows: Belgium: 3 sites; Brazil: 1 sites; Canada:
~3 sites; Czech Republic 3 sites; Croatia: 2 sites; Israel: 6 sites; Macedonia: 2 sites; Poland: 3 sites; Russia: 5 sites; Serbia: 4 sites; Slovenia: 1 sites; South Africa: 2 sites; Spain: 5 sites; and United States: 23 sites."|
729411|NCT01835379||
729412|NCT01835262||
729413|NCT01835223||
729414|NCT01835158||
729415|NCT01835145||
729416|NCT01835132|Initial Phase: All participants have injections at Baseline, Wks 4, 8, and 12 with follow up visits at Wks 2, 16, and 28. 1st Extension Phase: If improved by Wk 16, visits every 4 wks until Wk 36 and then 2 visits at Wks 40 and 52. As-needed 2nd Extension Phase: At Week 52, if eligible, may continue with injections at Wks 52, 54, 58 and 62.|
729417|NCT01835015|Subjects were recruited from 4 investigational centers located in the US.|Of the 50 enrolled,19 subjects were exited as screen failures prior to randomization. This reporting group includes all assigned subjects (31).
729418|NCT01834729||A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.
729419|NCT01834716|Participants were recruited via study invitations mailed to persons by age and zip code. Local community presentations were also conducted to recruit subjects.|
729420|NCT01834651||
729421|NCT01834586|multiple sclerosis clinic|
729422|NCT01834404|Subjects were recruited from patients attending the Mayo Clinic in Rochester, Minnesota.|
729423|NCT01834274|Participants took part in the study at 25 sites in the United States and 1 site in Canada from 18 May 2013 (first patient to sign informed consent) to 05 March 2014.|Participants with a diagnosis of Type 2 Diabetes Mellitis were enrolled equally in 1 of 2 treatment groups, once a day fasiglifam 50 mg or Sitagliptin 100 mg in combination with metformin.
729424|NCT01834261|Subjects were recruited at MIT and at MGH (distinct populations of participants). They randomly received Syntocinon or Placebo (40 IU) first. 51 subjects consented. 10 dropped out prior to receiving either drug. 21 at MIT and 20 at MGH completed at least one visit where they received either placebo/oxytocin. A total of 39 completed both.|All subjects who consented and passed history and physical examination received both oxytocin and placebo on different days. Exclusion criteria included any significant known medical conditions, metal in the body or claustrophobia, current use of psychotropic medications, BMI > 30, pregnancy, breastfeeding, smoking, high blood pressure and anosmia.
729425|NCT01834222||
729426|NCT01834144||
729427|NCT01834027||
729428|NCT01833988||
729429|NCT01833936||
729430|NCT01833897||
729431|NCT01833845||
729432|NCT01833832||
729433|NCT01833754|This study was conducted at 5 centers in the United States. The first participant enrolled on 22 April 2013 and the last participant enrolled on 05 November 2013.|
729434|NCT01833741||
729435|NCT01833546|First participant (informed consent): 18 April 2013. Study completion date: 25 January 2016.|
729436|NCT01833533||
729437|NCT01833494||
729438|NCT01833481||
729439|NCT01833455||
729440|NCT01833403||
729441|NCT01833247||
729442|NCT01833169||Prior to informed consent, patient was pre-identified to have activation of the P13K pathway confirmed via Genomic Profiling Report and whose disease had progressed on or after standard treatment
729443|NCT01833143||
729444|NCT01833130|The Safety Population includes all 52 patients who received at least one injection with the study treatment. The Intent-to-Treat (ITT) population consists of all 45 randomized patients. Seven (7) patients were excluded from the ITT population as they were withdrawn from the study due to a randomization error.|
729445|NCT01833117|Participants were recruited from 3 study centers located in the US.|Of the 75 enrolled, 13 participants failed to meet inclusion/exclusion criteria and were exited as screen failures prior to randomization. This reporting group includes all enrolled and randomized participants (62).
729446|NCT01833078|Participants were recruited from the outpatient medical practice serving the geriatric population at University of Pennsylvania via an electronic alert to physicians. Ten subjects were screened in order to obtain five eligible participants.|
729447|NCT01833065||Trial included 4-week Screening and 2-week Pretreatment Period before patient randomization to treatment sequences i.e. EBX 10/EBX 10, EBX 10/PLCBO, EBX 5/EBX 5, EBX 5/PLCBO and PLCBO/EBX 10. The total study duration was of 16 weeks: the efficacy assessments focused on the first 12 weeks, while safety assessments focused on whole 16 weeks
729448|NCT01833026||None to report
729449|NCT01832961||
729450|NCT01832818||
729451|NCT01832766|Age-eligible participants were recruited from May 2005 to May 2010 and were recruited from local mental health centers.|14 recruited; 14 screened: 1 excluded (did not meet inclusion criteria)
729452|NCT01832753||
729453|NCT01832727|This study was conducted at 18 centers in the United States and France.|Eighty-one subjects were screened; sixteen were not enrolled due to entry criteria violations.
729454|NCT01832610||Of the 101 enrolled subjects, 17 subjects enrolled post-transplant and were no longer on the HVAD device at the time of enrollment, leaving 84 subjects who enrolled while still on the HVAD device.
729455|NCT01832532||Enrollment fell short of goal for each cohort
729456|NCT01832506|First/last subject (informed consent): 15 April 2013/20 September 2013. Last subject completed: 22 October 2014.|
738151|NCT01277159||
729457|NCT01832493|Patient recruitment occurred from September 27, 2013 to January 28, 2016.|Eight patients exited the study prior to undergoing the research procedure: Four did not meet inclusion/exclusion criteria; In 2 cases, the physician deemed withdrawal medically necessary; and in 2 cases, the surgeon was unable to place the left ventricular (LV) lead.
729458|NCT01832480||
729459|NCT01832402|Adult participants (age>18) with an active diagnosis of cancer were recruited between 6/2013 and 3/2015 from the Supportive Care Center outpatient clinic of MD Anderson Cancer Center who satisfied the inclusion and exclusion criteria.|
729460|NCT01832259||
729461|NCT01832155|Recruitment took 9 months through placing flyers in various community centers; distributing press releases to the University's Alumnae Newsletter, community newsletters and newspapers; presenting health talks at community senior programs; and accessing the data base and mailing invitation letters out to patients from the University Clinic.|No significant events and approaches for the overall study following participant enrollment/prior to group assignment.
729462|NCT01832090||
729463|NCT01832038|The study started to enroll participants in March 2013 and concluded in July 2019.|Participant Flow refers to the Safety Set.
729464|NCT01831960||
729465|NCT01831934||
729466|NCT01831921|Baseline and randomization visits began in January 2014 and concluded in June 2016. In a roughly 26-month period, 225 participants were randomized (150 lifestyle intervention; 75 enhanced usual care) to take part in La Comunidad.|
729467|NCT01831856|It was planned to randomise a total of 152 patients. Due to low recruitment, the study recruitment was interrupted prematurely. Instead of 152 patients, 157 patients were screened and a total of 135 were finally randomised. 1 patient received no dose of the study treatment and was also not included in the analyses.|Patients were randomised after 1 to 4-week run-in period without study treatment.
729468|NCT01831817|Participants were recruited at the clinical site|Participants aged 18 and 55 years of age (inclusive), in good general health, with preexisting self-reported and clinically diagnosed tooth sensitivity were enrolled in this study.
729469|NCT01831804|This was a randomized, placebo-controlled, single-blind, parallel-group, two part (Part A and Part B) study in healthy volunteers (HVT) and participants with diabetic foot ulcer (DFU).|A total of 65 par. were randomized, however 2 par. did not receive study treatment and were excluded from analysis. All data tables reflect the total of treated par. (63).
729470|NCT01831791|Male participants with androgenetic alopecia types III vertex IV and V per Norwood Hamilton classification were enrolled into study.|This outpatient study consisted of a Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks).
729471|NCT01831765|Out of 281 sites, selected for recruitment, 165 sites in 9 countries enrolled subjects in the run-in period, of which 163 sites later assigned subjects to randomised treatment: Belgium:5 sites, Canada:12 sites, Czech Republic:5 sites; Finland:6 sites; Germany:25 sites; Hungary:5 sites; Poland:6 sites; United Kingdom:9 sites; United States:92 sites.|Eligible subjects received once/twice daily insulin detemir and NovoRapid®/NovoLog® during 8 week run-in period. In total, 1290 subjects entered the run-in period, of those147 subjects were run-in failures. Hence 1143 subjects entered the 26-week treatment period followed by a 26 week additional treatment period.
729472|NCT01831726||
729473|NCT01831596||
729474|NCT01831544||
729475|NCT01831466|Participants with mild (PGA-C score of 2), moderate (PGA-C score of 3), or severe (PGA-C score of 4) chronic plaque psoriasis were recruited for this study. The primary analysis population for this study included only the participants with mild and moderate disease.|
729476|NCT01831258||
729477|NCT01831232||
729478|NCT01831219||
729479|NCT01831154||
729480|NCT01831089|A total of 69 patients were enrolled at 3 investigational sites: 55 Group A (paclitaxel plus PM01183) and 14 Group B (paclitaxel+PM01183 and BEV). Patients participated in this trial between 15/Oct/2013 and 14/Jul/2016 (last FU). The first dose of the first cycle was given on 23/Oct/2013 and the last dose of the last cycle was given on 23/Jun/2016|Signed IC,Age 18-75,ECOG PS≤1,Life expectancy≥3 months,Histologically/cytologically confirmed diagnosis of advanced and/or unresectable disease according to the groups,adequate status patient,no AEs,negative pregnancy test.
729481|NCT01831076||
729482|NCT01830972|Participants completing study UX001-CL201 (NCT01517880) were eligible to continue treatment under this protocol. Additional participants with glucosamine (UDP-N-acetyl)-2-epimerase (GNE) myopathy were enrolled to assess Sialic Acid Extended Release/Sialic Acid Immediate Release (SA-ER/SA-IR) in a treatment naïve population.|A total of 46 crossover participants started the study in Part 1, with an additional 13 naive participants starting the study in Part 2.
729483|NCT01830933||
729484|NCT01830920||
729485|NCT01830881|This randomized, double-blind, placebo-controlled trial was conducted at Planned Parenthood Columbia/ Willamette in Portland, Oregon, between May 2013 and December 2013.|
729486|NCT01830855||A total of 3596 participants were randomized in this study, out of which 3590 participants received vaccination.
729487|NCT01830842||
729488|NCT01830816|Participants took part in the study at 6 investigative sites in the United States and Canada from 16 September 2013 up to 18 November 2016.|Participants with a diagnosis of relapsed or refractory multiple myeloma (RRMM) or advanced solid tumors who had normal renal function or severe renal impairment including end-stage renal disease requiring hemodialysis (ESRD) were enrolled to receive ixazomib orally in the study.
729489|NCT01830790||
729490|NCT01830699|Subject recruitment was from March 2013 to December 2013. Subjects were recruited from the Internal Medicine (IM) or IM Subspecialties Clinic at a single academic community-size hospital.|Please refer to inclusion and exclusion criteria.
729491|NCT01830621||
729492|NCT01830595||One participant was administratively withdrawn prior to receiving medication.
729493|NCT01830543||
729494|NCT01830205|The study was conducted at 2 centers in United States of America.|A total of 58 participants were enrolled and 36 were treated with study drug. Remaining 22 were not treated (14 no longer met study criteria, 4 other reasons, 2 administrative reasons and 2 withdrew consent). Participants were grouped by Cockcroft-Gault creatine clearance method for primary analysis.
729495|NCT01830140||
729536|NCT01827475|Patients were recruited from the emergency department over a 1 year period|
729496|NCT01830127|35 patients were enrolled and treated with Deleobuvir (DBV) / Faldaprevir (FDV) / Ribavirin (RBV): 18 patients with Child-Pugh A (mild hepatic impairment) and 17 patients with Child-Pugh B (moderate hepatic impairment).|This was phase IIb open label study of BI 207127 (Deleobuvir) in combination with faldaprevir and ribavirin in patients with mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection.
729497|NCT01829997||
729498|NCT01829919||
729499|NCT01829711|The study was conducted across 14 countries (the USA, France, Italy, Germany, Belgium, Canada, Czech Republic, Ireland, Israel, Norway, Poland, Serbia, Spain, and United Kingdom).|
729500|NCT01829516||Sixty-one nontreatment-seeking subjects were recruited online. Eligible subjects met DSM-IV criteria for alcohol abuse, but were excluded if physically dependent on alcohol. These subjects were screened to yield 39 eligible subjects. Of the 39 subjects deemed eligible, 7 did not return after the screening visit, resulting in 32 enrolled subjects.
729501|NCT01829503||
729502|NCT01829477|Participants took part in the study at 18 investigative sites in the United States, Slovakia, Bulgaria, Hungary, and Canada from 19 April 2013 to 11 February 2014.|Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM), inadequately controlled when treated with only diet, exercise and a sulfonylurea for at least 12 weeks prior to screening, were enrolled in 1 of 2 treatment groups: placebo; fasiglifam 50 milligram (mg).
729503|NCT01829464|Participants took part in the study at 49 investigative sites in the United States from 01 April 2013 to 12 March 2014.|Participants with historical diagnosis of type 2 diabetes who were inadequately controlled while on sitagliptin 100 milligram(mg) (with/without metformin) or on Dipeptidyl peptidase-4 inhibitor other than sitagliptin(with/without metformin) therapy enrolled in 1 of 3, placebo; fasiglifam 25 mg once daily (QD); fasiglifam 50 mg QD treatment groups.
729504|NCT01829425|Patients recruited March 2013 through October 2016 from the UNMH Urogynecology clinics|"Patients required to keep 3 day voiding diary to confirm their eligibility for the study prior to randomization. Pts also underwent hypnotic susceptibility testing prior to randomization.
~Of those consented, 13 did not go on to randomization: 8 were excluded because they did not meet inclusion criteria and 5 were lost to further followup"
729505|NCT01829399||
729506|NCT01829360||
729507|NCT01829347||
729508|NCT01829295||
729509|NCT01829243|Patients were randomized to receiving milnacipran-washout-placebo or placebo- washout-milnacipran for 6 weeks, followed by a 1 week washout and then cross over to the other arm for another 6 weeks. The overall trial lasted 13 weeks starting on July 2011 and ending in May 2013.|
729510|NCT01829230||
729511|NCT01829217||
729512|NCT01829191||Of those 174 screened subjects, 42 were ineligible to participate in the study and 5 eligible subjects did not randomize to the study arm.
729513|NCT01829165||85 participants were enrolled and 33 were randomized.
729514|NCT01829113|Between August 2013 and February 2015, a total of 155 patients (77 patients on the OGX-427 (apatorsen) arm and 78 patients on the placebo arm) were enrolled and randomized on the study.|Subjects were enrolled and randomized in a 1:1 ratio to receive a combination of pemetrexed and carboplatin plus either OGX-427 (apatorsen) or a placebo.
729515|NCT01829048||
729516|NCT01828983||
729517|NCT01828593||Study consists of 2 phases, the Placebo-controlled (PC) phase and the Placebo-free (PF) extension phase. Participants were randomized in a 1:1:2:2 ratio into 4 groups: Placebo for 4 wk PC phase followed by either 2.5g or 5.0g BID for 20 wk PF phase or SBI 2.5g or 5.0g BID for 4-wk PC phase followed by 2.5g or 5.0g for 20 wk PF phase.
729518|NCT01828567||
729519|NCT01828554||
729520|NCT01828515|24 participants with at least one post-baseline visit were recruited at our research clinic in Dallas, TX and included for analysis.|Healthy control participants without any history of major psychiatric illness, drug/alcohol abuse/dependence, history of neurological disorders, or significant medical conditions were included.
729521|NCT01828476|Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 6/4/2013 and was closed by the Principal Investigator on 3/3/2016 due to slow accrual.|We are reporting results on 13 eligible patients. Arm A dose escalation was completed. The study was then closed to due to slow accrual and the Investigator leaving the organization.
729522|NCT01828281|Subjects were recruited from patients referred by general practitioners to the respiratory clinics with clinical suspicion of sleep-disordered breathing over the period 17 Feb 2012 to 30 Oct 2013. Overnight polysomnography (PSG) were performed as inpatient at the hospital.|51 subjects were excluded as 26 had AHI <5 events/hour and 25 were not interested in continuing study.
729523|NCT01828255||
729524|NCT01828216||
729525|NCT01828164||11 subjects did not meet inclusion criteria after enrollment. For this reason, 60 subjects were enrolled but only 49 entered the participant flow.
729526|NCT01828112|115 patients received ceritinib and 116 received chemotherapy among which 40 patients received pemetrexed, 73 patients received docetaxel, and 3 were not treated (2 patients due to Investigators decision and 1 due to subject/guardian's decision).|A total of 231 patients were randomized in a 1:1 ratio to the ceritinib arm (n=115) or the chemotherapy arm (n=116).
729527|NCT01828099|Patients were randomized in a 1:1 ratio to either ceritinib (750 mg once daily fasted) or chemotherapy (platinum-based doublet with pemetrexed followed by pemetrexed maintenance in patients without progressive disease after 4 cycles).|376 patients completed the screening phase and were randomized to either ceritinib or chemotherapy arm in the treatment phase. 12 patients randomized to the chemotherapy arm were not treated. All patient randomized to ceritinib were treated.
729528|NCT01828073|"Cohort 1 participants were enrolled from 11 sites in the USA. Enrollment period was from May 2011 through September 2012.
~Cohort 2 participants were enrolled from 4 sites in Brazil, 1 site in South Africa, 1 site in Tanzania, 1 site in Thailand, and 3 sites in the USA. Enrollment period was from January 2015 through March 2018."|
729529|NCT01828034||
729530|NCT01828021|Enrollment occurred at 6 US oncology centers -- 4 academic institutions and 2 clinical research centers, between May 2013 and November 2016.|
729531|NCT01827930||
729532|NCT01827839||
729533|NCT01827787|Participants were enrolled between May 2013 and March 2016.|
729537|NCT01827462||
729539|NCT01827358|Infants less than 24 months of age were recruited from among those admitted to the NICU or ICU at one of the participating centers found to have a surveillance nasal swab culture positive for SA. Recruitment was performed sequentially as infants became eligible without regards for race, ethnicity, gestational age or gender.|Infants were screened for nasal SA colonization (MRSA or MSSA) and only those who were colonized (not infected) were offered enrollment.
729540|NCT01827332|Participants recruited between July 2014 and May 2015 primarily through media and internet advertisements.|
729541|NCT01827319||
729542|NCT01827306||
729543|NCT01827267||
729544|NCT01827254||
729545|NCT01827163||
729546|NCT01827046|Recruitment and randomization occurred at 78 hospitals in USA, Canada, Europe, Australia, and Asia|
729547|NCT01826981|Participants were enrolled at a total of 2 study sites in New Zealand. The first participant was screened on 3 April 2016. The last study visit occurred on 25 May 2015.|446 participants were screened.
729548|NCT01826851||
729549|NCT01826812||Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each eye. Nasal and temporal conjunctiva are graded separately with a lissamine green staining score between 0 and 3 for each area.
729550|NCT01826604|This was a randomized controlled trial of obese women (BMI ≥30 kg/m2) undergoing non-emergent Cesarean section at St. Mary's Health Center, March 2013 to September 2014. Patients were randomized to the treatment group (using the Alexis O C-section retractor) or to the control group (using conventional hand-held retractors).|Non-emergent Cesarean delivery was defined by our institution's Cesarean section acuity scale, included those in which there was no immediate threat to the life of the patient or fetus. Not all Cesarean deliveries were elective, patients were included if there was typical time for routine Cesarean section preparation.
729551|NCT01826513||
729552|NCT01826487|A total of 291 participants were screened for eligibility, of which 61 participants did not meet entry criteria.|A total of 230 eligible participants were randomized in 1:1 ratio to receive either placebo or ataluren. 2 participants, 1 in each treatment arm, were excluded from intent-to-treat (ITT) population; as they did not have at least 1 valid post-baseline 6-minute walk distance (6MWD) value, a requirement for inclusion in ITT population.
729553|NCT01826448|A total of 13 participants who met all inclusion and none of the exclusion criteria were enrolled in the study.|This was an open-label, multicenter, Phase 1b, dose-escalation study, followed by an Extension Phase at the recommended Phase 2 dose (RP2D) of both drugs. During Dose-escalation (planned n=40), cohorts of 3 to 6 participants were enrolled to identify the RP2D of each agent to be administered to patients enrolled in the subsequent Extension Phase.
729554|NCT01826422|In this study were enrolled DMD/DMB patients from four Hospitals from Mexico city.|
729555|NCT01826370||
729556|NCT01826227||
729557|NCT01826214||35 patients were randomized but only 34 patients received at least one dose of study drug in the LDE225-800 (schedule B ) arm.
729558|NCT01826201|This was a multi-site study conducted at three sites in the United States of America. Date first subject enrolled: 22 April 2013 and date last subject completed: 13 August 2013.|
729559|NCT01825941|Protocol anticipated enrollment of around 400 participants, however Data Safety Monitoring Board recommended enrollment cut to approximately half|
729560|NCT01825889||
729561|NCT01825876||
729562|NCT01825837|This was a multicenter study. Approximately 60 centers in Europe, South America, and South Africa enrolled patients in this study.|This was an extension study consisting of 2 parts. In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily
729563|NCT01825798||
729564|NCT01825785|This study was conducted at 4 centers in the United States (US) from 14 November 2007 to 2 December 2008.|Participants were enrolled into 1 of 6 cohorts. In each of cohorts 1 to 4, healthy postmenopausal women were randomized in a 3:1 ratio to receive romosozumab or placebo; In each of cohorts 5 and 6, healthy men were randomized in a 3:1 ratio to receive romosozumab or placebo.
729565|NCT01825655|One other patient consented but did not qualify to begin the study.|
729566|NCT01825577||
729567|NCT01825408||
729568|NCT01825200|Subjects were recruited at outpatient medical clinics over a period of five weeks.|
729569|NCT01825122||
729570|NCT01824979||
729571|NCT01824901|This study opened to accrual on September 19, 2013 and was suspended to accrual on January 29, 2014 after each of the first two patients had been registered to the first dose level of the phase I and experienced DLTs. The study was subsequently closed on April 17, 2014 after having met the predefined criteria for closure per study design.|
729572|NCT01824823||
729573|NCT01824693||
729574|NCT01824602|STUDY DATES: From: 28 Feb 2006 To: 13 Nov 2006 Study centers: 25 study centers in Europe, South Africa and South America: 7 centers in Croatia, 6 centers in Spain, 6 centers in Argentina, 1 center in Chile and 5 centers in South Africa.|Patients who met the selection criteria at randomisation visit (V) (V2, Day 1) were randomised to 1 of 4 treatment groups: 600, 1200, or 1800 mg eslicarbazepine acetate, or placebo. Patients started the assigned treatment on Day 1 and were followed for up to 3 weeks.
729575|NCT01824589||
729576|NCT01824576||
729577|NCT01824498|"6
~137 participants screened, 66 did not meet criteria, 71 were eligible but 39 declined participation,32 screened in clinic but 2 didn't meet eligibility on further screen and 6 declined participation"|Subjects enrolled prior to randomization (N=18)
729578|NCT01824472||
729579|NCT01824446||
729580|NCT01824394|The first subject was enrolled on April 1, 2013. Enrollment was terminated on May 25, 2017.|This was a prospective, multicenter, randomized, controlled, two arm single-blind design. Enrolled subjects N=481 (subjects signed informed consent) 468 does not include 13 subjects excluded prior to randomization.
729581|NCT01824355||
730569|NCT01755234|Subjects were recruited 12/2012-04/2014. 101 subjects were assessed for eligibility, 4 did not meet inclusion criteria and 7 declined to participate. 90 subjects were randomized.|
729582|NCT01824342|This was a single-arm, open-label extension (OLE) phase of a phase 3, randomized, double-blind study (Study 20050147; NCT00286091) comparing denosumab with placebo on prolonging bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer.|All participants received denosumab during the OLE phase; in the parent study participants were initially randomized in a blinded manner to receive denosumab at a dose of 120 mg or placebo every 4 weeks.
729583|NCT01824303||31 participants signed the informed consent form and were enrolled in the study, 30 participants had the investigational product inserted and are included the Intent-to-treat Population.
729584|NCT01824290||Per protocol and statistical analysis plan (SAP), the primary and secondary analysis from period 1 were performed to compare all tadalafil participants together versus all placebo participants together. Period 2 data will be reported after study completion.
729585|NCT01824160||
729586|NCT01823991|Participants were enrolled at Moffitt Cancer Center between July 2014 and February 2017.|Participants were randomized to receive Cognutrin (n-3 fatty acids + anthocyanins) or placebo for a period of 3 months.
729587|NCT01823861||
729588|NCT01823679||
729589|NCT01823653||
729590|NCT01823614|Enrollment of patients will be conducted during 4 months of study. Patients will be selected from the AIDS centers and the Republican Clinical Hospital for Infectious Diseases, which are participants of the study. Totally there will be 12 AIDS centers. Expected number of patients will be 70 people per participant.|Patient exclusion criteria: Pregnancy at the time of obtaining of biological material for women, patients receiving cytotoxic agents, patients receiving immunomodulatory drugs, pParticipation in clinical trials with experimental drugs, experience of using of CCR5-antagonists.
729591|NCT01823536|Subjects were recruited from 22 study sites.|All subjects were included in the trial.
729592|NCT01823510||
729593|NCT01823497||
729594|NCT01823341|The study was conducted at Stanford University (Stanford, CA), the Barbara Davis Center (Denver, CO), and Children's Hospital, London Health Sciences Centre (London, ON). A total of 53 subjects 11-14 years old and 44 subjects 4-10 years old were enrolled. Forty-five of the 11-14 year old subjects and 37 of the 4-10 year old subjects completed.|After the run-in phase, a 42-night randomized trial was conducted in which each night was randomly assigned to have either predictive low glucose suspend system active (intervention) or inactive (control) with half of the nights being intervention and half control nights.
729595|NCT01823328||14 patients withdrew consent.
729596|NCT01823289||
729597|NCT01823224|Adult patients (male and non-pregnant females, 18 years of age or older) with symptomatic cholelithiasis and ASA rating of I-III scheduled to undergo elective LapChole were eligible for this trial.|
729598|NCT01823146|Participants were recruited between 08/2013 and 09/2014. Recruitment phone calls were conducted at the Social-Cognitive and Affective Development Lab at University of Florida.|
729599|NCT01823107||
729600|NCT01822925|A total of 185 subjects were screened in this study from which, 128 subjects were randomized to the treatment groups, and 57 subjects were categorized as screen failure. Thirty-two (32) subjects were randomized to each of the four (4) study treatment groups: 900 mg DA-9801, 600 mg DA9801, 300 mg DA-9801 and placebo.|
729601|NCT01822899|Participants who met the eligibility criteria at Screening (Visit 1) completed a 7- to 14-day Run-in Period, followed by a 12-week Treatment Period.|A total of 717 participants, representing the enrolled participants, were randomized to study treatment. Of these, 716 participants comprised the Intent-to-Treat Population (participants randomized to treatment who received >=1 dose of randomized study medication in the treatment period).
729602|NCT01822886|date of first enrollment: 08 Jan 2013 date of last completed:15 Jul 2018|
729603|NCT01822821||
729604|NCT01822756||
729605|NCT01822691|Participants were enrolled at Moffitt Cancer Center between August 2013 and January 2014.|
729606|NCT01822678|"Study centres: 23 centres: 2 centres in Austria, 6 centres in Czech Republic, 6 centres in Slovakia, 1 centre in Portugal, and 8 centres in Romania.
~First patient enrolled: 02 December 2005 Last patient completed: 23 November 2006"|Patients who met the selection criteria at the randomisation visit (visit 2, Day 1) were randomised to 1 of the 3 treatment groups
729607|NCT01822665|Participants were recruited at the clinical site.|Of 41 participants screened, 12 did not meet the study criterion and one participant withdrew consent. Remaining 28 participants were randomized into the study to received all the four treatments in a sequential manner.
729608|NCT01822587||
729609|NCT01822574|Participants were recruited from the orthopedic department at Mayo Clinic in Rochester, Minnesota.|
729610|NCT01822561|Patients with central serous chorioretinopathy were recruited in the ophthalmology clinic at Tufts Medical Center in Boston, MA between April 2013 and April 2017.|
729611|NCT01822548|Individuals with type 2 diabetes were recruited in the outpatient Diabetes Unit of Parma University Hospital|
729612|NCT01822535||
729613|NCT01822496||
729614|NCT01822457||
729615|NCT01822366||
729616|NCT01822353||
729617|NCT01822301|"Recruitment will come from subjects who have successfully completed IRB# PRO09060101 entitled Structural Fat Grafting for Craniofacial Trauma. These subjects have expressed a strong desire to participate in this study and have been asked to sign the Research Registry IRB#PRO07050333."|
729618|NCT01822223||
729619|NCT01822197||
729620|NCT01822132||After consenting, 13 participants did not meet screening inclusion criteria and were removed from the study and 11 participants withdrew, leaving 52 eligible participants for randomization into a treatment group (Naltrexone or Placebo)
729621|NCT01822119||
729622|NCT01821963|Recruitment Period: April 2013 to February 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.|Study terminated early due to changes in research, alternate therapeutic treatment options.
729623|NCT01821937||
729624|NCT01821859||
729625|NCT01821807|"All the patients in the first month of study were selected in group Quincke. All the others recruited in the second month of the study were enrolled in group Atraucan."|Non-compliance to the suggestions of the investigators for the part of patients and loss of the contact with the patient were criteria for exclusion.
729628|NCT01821560|Participants were recruitment between March 2013-March 2017 via word of mouth, flyers, an online study database managed by the University of Pennsylvania, and also social media advertisements (Facebook).|Prior to study group assignments, all participants must first provide informed consent and then are found to be eligible to participate in the study after completing the screening process. The screening process included a full physical and psychological evaluation to ensure all participants are both physically and mentally healthy enough.
729629|NCT01821534||
729630|NCT01821417||
729631|NCT01821391||
729632|NCT01821378||
729633|NCT01821352||
729634|NCT01821326||
729635|NCT01821300||
729636|NCT01821118||
729637|NCT01821105||
729638|NCT01820754||
729639|NCT01820637|There were 57 subjects enrolled at 14 investigative centers in Europe, Australia and New Zealand. The first subject was enrolled on 23 August 2013. Enrollment was completed on 03 March 2014, when the last subject was enrolled.|
729640|NCT01820585|"Subjects were screened in 84 centres in 16 European countries (Austria, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Ukraine and United Kingdom).
~Study initiation date: 21 Apr 2009 Study completion date: 03 Sep 2010;"|After completing procedures at V1, subjects returned to the study centre for V2. At V2, subjects, who had completed at least 4 subject diary pain assessments satisfactorily within the past 7 days, had an average pain score that was ≥4 and ≤9 and continued to meet all study entry criteria, were randomly assigned to 1 of the 4 treatment groups.
729641|NCT01820559||
729642|NCT01820416||
729643|NCT01820364|"The study began on 04-Nov-2013 (First Subject First Visit) to the CLGX818X2102 (LOGIC 1) study. A total of 15 subjects were enrolled. The last subject's last visit occurred on 23-Mar-2015.
~Not completed subjects represents subjects that stopped treatment early, due to the corresponding reason."|"After careful evaluation of slow enrollment and the BRAF-mutant melanoma treatment landscape, recruitment was permanently halted on 26-Jul-2014.
~This recruitment halt was not a consequence of any safety concern and patients who were ongoing in the study continued to be treated as per protocol."
729644|NCT01819935||
729645|NCT01819922||
729646|NCT01819883||
729647|NCT01819844||
729648|NCT01819727||
729649|NCT01819597|Patients were recruited at UCLA Medical Center and Cedars Sinai Medical Center in Los Angeles.|
729650|NCT01819506|Recruited from a University Stroke Rehabilitation Research Registry.|
729651|NCT01819415|Recruitment dates: February-August 2011 Location: Maisonneuve-Rosemont Hospital, University of Montreal, Quebec, Canada|At least 3 months of no other treatments for wet-AMD in groups 1 and 2 and no treatment at all for group 3.
729652|NCT01819311||
729653|NCT01819272||
729654|NCT01819233||
729655|NCT01819194||A total of 64 subjects were enrolled in this study. Of the enrolled subjects 2 did not meet the eligibility criteria and 62 were dispensed a study lens. Of the dispensed subjects 60 completed the study and 2 were discontinued.
729656|NCT01819129|Out of 150 sites, which were selected for recruitment, 128 sites in 9 countries enrolled subjects in the run-in period, of which 123 sites later assigned subjects to randomized treatment: Canada:9 sites; Croatia:6 sites; India:6 sites; Israel:6 sites; Russia:12 sites; Serbia:9 sites; Slovakia:5 sites; United Kingdom:7 sites; United States:63 sites.|The trial included an 8-week run-in period and a 26-week treatment period. During the run-in period, the subjects received insulin glargine along with metformin. In total, 881 subjects entered the run-in period, of these 192 subjects were run-in failures. Hence, 689 subjects entered the 26-week treatment period.
729657|NCT01818804||
729658|NCT01818765||
729659|NCT01818752|This study was conducted at 183 centers in Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, and United States.|Eligible participants were randomized in a 1:1 ratio. Randomization was stratified by International Staging System (ISS) stage (stage 1 versus stages 2 or 3), choice of route of bortezomib administration (intravenous [IV] versus subcutaneous [SC]), region (North America, Europe, Asia Pacific, or other), and age (< 75 years versus ≥ 75 years).
729660|NCT01818726|Estimated number of patients was 25; the actual number of patients enrolled in the study and included in efficacy analysis was 15.|The study enrolled adult transfusion-dependent patients with Aplastic Anaemia (AA) on programmed immune suppressive treatment.
729661|NCT01818700|Duration of study: from 16 Oct. 2012 to 28 Jun 2013|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN will be started from 5 μg/h for 2 weeks, and proper titration(up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision. judgement by considering any titration needed situation.
729662|NCT01818596|Participants were enrolled at study sites in North America, Australia, Asia, and Europe. The first participant was screened on 27 March 2013. The last study visit occurred on 18 July 2018.|380 participants were screened.
729663|NCT01818531||
729664|NCT01818518||
729665|NCT01818492||Patients were screened within 1 week prior to the first administration of emapalumab (NI-0501). 66 patients were screened, and 45 were enrolled and treated.
729666|NCT01818427||
729667|NCT01818414||
729668|NCT01818336|This was a prospective, open-label investigation of skin testing with the Penicillin Skin Test Kit conducted at 13 asthma and allergy centers in the United States.|455 History pos subj enrolled + 2 control subj @ 13 centers. All 481 subj were skin tested(ST) and included in safety population. 64 subj (all history pos) had pos or discordant skin tests and were excluded from ITT population of 391(455 - 64). The subset of 59 ST pos subjects were invited back at 4 weeks for repeat ST; 47 ST pos subj returned
729751|NCT01812655|Participants recruited from 6/2010 until 4/2012 in the outpatient Burn Center clinic.|One participant was re-assigned to standard care prior to group assignment when the virtual reality (VR) equipment failed during set-up.
729752|NCT01812473||
729753|NCT01812057||Of the 52 subjects that were enrolled, 3 subjects were not randomized due to later being deemed ineligible for the study; therefore, 49 subjects started on study.
729669|NCT01818297|This study enrolled adult patients with chronic, intractable post-surgical back pain. First enrollment was in April 2013. Enrollment was suspended in September 2014 due to slow enrollment. The last subject visit was in March 2016. The planned enrollment was 323 subjects, with 218 randomized. Actual enrollment was 137 subjects with 62 randomized.|Of the 137 enrolled subjects, 62 were implanted and randomized. Of the 75 subjects who discontinued from the study prior to randomization, 54 did not meet inclusion/exclusion criteria, 12 withdrew consent or declined device implant, 3 discontinued due to study suspension, and 6 discontinued for other reasons.
729670|NCT01818284|Recruitment Period: October 16, 2013 to May 1, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|
729671|NCT01818245||
729672|NCT01818141||
729673|NCT01818063||
729674|NCT01817959||A total of 51 subjects were randomised into the trial. Three of these subjects did not have a transplant and never received randomised medication. Hence, a total of 48 subjects took trial medication and were included in the Safety Population.
729675|NCT01817907||
729676|NCT01817855|Both the lung deposited doses and total delivered doses are reported in clinical study report, and the conversion is: In cohort 1 to 6, the lung deposited doses 151 µg, 303 µg, 595 µg, 1191 µg, 1160 µg and 580 µg are equivalent to the delivered doses 261µg, 522µg, 1027µg, 2053µg, 1932µg and 966µg, respectively.|The screening period for all the subjects was from Day -42 to Day -2. Admission on day -1. A 8 to 9 days treatment period, 7 to 9 days follow up period. It was planned to enrol to 32 healthy volunteers and 20 COPD to the study, but 4 COPD patients (Due to stopping cohort 4 prematurly) and one healthy volunteer (in cohort 3) were not enrolled.
729677|NCT01817790|Participants were recruited at 6 clinical sites in the US.|Of the 855 participants screened, 626 were randomized in the study. Of the 229 participants not randomized into the study, 151 did not meet the study criteria; 3 developed AEs; 10 were lost to follow-up; 4 violated protocol; 28 withdrew consent; and the remaining 33 were not randomized for other reasons.
729678|NCT01817777|Participants aged >=18 years with a diagnosis of Type II diabetes mellitus (T2DM) and a glycated hemoglobin (HbA1c) value no higher than 9.0%; with evidence of a physician-supplied prescription for metformin use and on a stable dose of metformin for 3 months prior to enrollment; and on no anti-diabetic medication other than metformin were enrolled.|Enrolled participants entered an 8-week Observational Phase (OP) prior to randomization to one of the treatment arms, followed by a 20-week Interventional Phase (IP). A total of 288 participants were planned; however, the study was prematurely discontinued when 36 participants had entered the OP. Of these 36, 31 had entered the IP.
729679|NCT01817764||A total of 707 participants, representing the enrolled participants, were randomized to study treatment. Of these, 706 comprised the Intent-to-Treat Population (participants randomized to treatment who received >=1 dose of randomized study medication in the treatment period).
729680|NCT01817725||
729681|NCT01817712||
729682|NCT01817582||A total of 102 participants were randomized in 1:1:1 to lotemax gel 0.5% and restasis 0.05%, lotemax gel 0.5%, or restasis 0.05% treatment groups.
729683|NCT01817530|Overall, 571 female participants were enrolled into the study across 86 sites (5 sites in the UK, 4 in Chile, 2 in Canada, 4 in Puerto Rico, and 71 in the US).|Four participants were randomized in error; they were not dosed and were excluded from all analyses including demographic summaries.
729684|NCT01817491||
729685|NCT01817374|A total of 22 patients was planned in this pilot study through the UAB Interdisciplinary Breast Center. However, due to early termination of the study, only six breast cancer patients were enrolled. Each participant received both interventions (2D ultrasound grayscale vs Definity Volume contrast enhanced ultrasound).|Recruitment for this study started in June 2015. The primary completion point was reached at July 2016, and study completion July 2016. The study was conducted at the University of Alabama at Birmingham.
729686|NCT01817075||
729687|NCT01816984||
729688|NCT01816906||
729689|NCT01816893||
729690|NCT01816776||
729691|NCT01816763|Research Assistants approached patients in the waiting rooms of primary care clinics (including women's health primary care clinics) at VA Palo Alto, Minneapolis, and Portland and queried them about their eligibility.|
729692|NCT01816711||
729693|NCT01816685||
729694|NCT01816594|Planned: Minimum 128 patients (in case of early stopping of both cohorts), maximum: 220 patients (if both cohorts would have proceeded into stage 2), and 174 patients if one cohort would have stopped early.|Screened: 68 patients Randomized and analyzed (safety and efficacy): 50 patients
729695|NCT01816477|Subjects were recruited from Mayo Clinic in Phoenix, Arizona.|
729696|NCT01816451|Participants were randomly assigned on August 2012 to either an interval,continuous training or control group from Sept to Dec. Tests and training were performed in a controlled laboratory condition.Tests were each separated by 24-48 h.One week before baseline they did a familiarization to submaximal test and all physiological measures.|Due to factors outside the present study, three individuals were removed from the program. Two individuals during maximal exercise test (VO2) showed clinical impairment test being interrupted by the doctor and the third individual presented a plantar fasciitis in the early familiarization.
729697|NCT01816295||
729698|NCT01816243||
729699|NCT01816230||
729700|NCT01816074|Eligible participants were recruited from the investigators' practices, clinic referrals, online advertisements, and radio advertisements. Participants were enrolled between September 2012 and December 2016.|7 participants didn't meet inclusion criteria, 1 decided not to participate after screening, 2 withdrew due to time commitment issues, 1 had a comorbid psychiatric disorder, 1 had a physical contraindication.
729701|NCT01816061||
729702|NCT01816048||
729703|NCT01815918||
729704|NCT01815840||229 participants were enrolled in 10 countries.
729705|NCT01815736|Participants were enrolled at study sites in North America, South America, Europe, Australia, and Thailand . The first participant was screened on 27 March 2013. The last Week 48 study visit occurred on 16 March 2015.|1559 participants were screened.
729754|NCT01812044|57 participants signed consent. 7 participants were withdrawn by PI prior to randomization.|
729755|NCT01812005||
729756|NCT01811953||
748571|NCT00727415||
729706|NCT01815671|Consecutive women presenting to a private endoscopy center for colonoscopy (with or without a preceding upper endoscopy) were offered participation. A computer generated randomization code was used to assign subjects to either TD or LL group. Subjects were blinded to which group they were assigned.|morbid obesity, pregnancy, uncontrolled gastroesophageal reflux disease, gastroparesis, scleroderma, achalasia, Crohn's disease, ulcerative colitis, history of a colon resection, Parkinson's disease, brain tumor, multiple sclerosis, ischemic optic neuropathy, glaucoma, active pulmonary infection
729707|NCT01815645||
729708|NCT01815515||22 participants enrolled, 5 screen failures, therefore only 17 participants started the study.
729709|NCT01815502||
729710|NCT01815424||
729711|NCT01815333|Recruitment Period: July 2013 to July 2019. Recruitment took place at the University of Texas MD Anderson Cancer Center.|
729712|NCT01815229||
729713|NCT01815138||All patients that met initial study criteria were enrolled and consented before starting ovarian stimulation. Final randomization occurred during stimulation. Therefore patients who were enrolled and consented may drop out before randomization, either because they did not meet the final inclusion criteria in did not undergo IVF.
729714|NCT01815099||
729715|NCT01815008||
729716|NCT01814878||
729717|NCT01814826|Participants took part in the study at 8 investigative sites in the United states from 10 April 2013 to 08 April 2018.|Participants diagnosed with acute myelogenous leukemia (AML) were enrolled to receive MLN4924 in combination with azacitidine intravenous during dose-escalation phase and MLN4924 in combination with azacitidine intravenous or subcutaneous during expansion phase.
729718|NCT01814813||
729719|NCT01814800||
729720|NCT01814787||
729721|NCT01814774||
729722|NCT01814761||
729723|NCT01814748||
729724|NCT01814722|Adults with human immunodeficiency virus (HIV) who were switching from first-line antiretroviral regimens to a second-line regimen were recruited at 48 academic and community-based practices in the U.S.A.|
729725|NCT01814696|Participants were recruited from a list of HF patients who had successfully completed a HF telemonitoring program at Massachusetts General Hospital (MGH) or Brigham & Women's Hospital (BWH) and had been hospitalized in the previous 24 months.|
729726|NCT01814670||
729727|NCT01814553||PD: Progressive Disease (PD)
729728|NCT01814397||
729729|NCT01814371||
729730|NCT01814332|Participants were recruited from Emory University School of Medicine, Mount Sinai School of Medicine, Baylor College of Medicine, and the San Francisco VA Medical Center between January 2010 and June 2014.|Subjects stopped psychotropic medications (w/ the exception of zolpidem, eszopiclone, and zaleplon for insomnia) w/in 2 weeks (6 weeks for fluoxetine) of Visit 1. Patients on ineffective psychotropic medications tapered off by the patients' prescribing doctor. 150 subjects did not proceed to randomization due to meeting exclusionary criteria.
729731|NCT01814241||
729732|NCT01814137|The trial was conducted at 20 sites in 4 countries as follows: Germany: 1 site; Malaysia: 2 sites; Turkey: 1 site; United States: 16 sites. The subjects in this trial were to continue from trial NN5401-3941 (NCT01680341).|Subjects who did not reach the HbA1c target < 7.0% on IDegAsp BID after 26 weeks of treatment in trial NN5401-3941 were enrolled in this trial.
729733|NCT01814046||Patients experiencing a sustained stable disease, partial or complete response may receive a second treatment when progression by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria is documented after evaluation by the principal investigator. Retreatment will consist of the same regimen that they had been given safely previously.
729734|NCT01814007||
729735|NCT01813890|The study was conducted from 11 January 2013 to 12 January 2014. Participants were recruited at 3 study centers in Taiwan.|
729736|NCT01813734||
729737|NCT01813721|"The first patient was enrolled on 13 December 2012 and the last patient enrolled on 08 January 2014.
~There were 205 registered investigators, 35 of whom did not enrol any participants and 5 who did not enrol any eligible participants and were excluded from the primary analysis set - investigators (PASI)."|
729738|NCT01813474|First patient enrolled on 25 March 2013. Last patient enrolled on 31 October 2013. Data cut off on 31 July 2014.|A total of 28 participants gave informed consent to join this study. Five participants were screen failures so that 23 participants were assigned and received study treatment
729739|NCT01813435||"12 participants of the experimental group withdrew consent or objected to use further use of data
~11 participants of the reference group withdrew consent or objected to use further use of data"
729740|NCT01813422|This study was conducted at 163 centers in 30 countries in Europe, North America, Asia Pacific, and Latin America. The first participant was enrolled on 18 April 2013 and the last participant enrolled on 12 January 2015.|Participants who met all entry criteria were randomized 1:1 to receive evolocumab 420 mg once monthly (QM) subcutaneous (SC) or placebo QM SC for 76 weeks. Randomization was stratified by region.
729741|NCT01813357||
729742|NCT01813214||
729743|NCT01813110||A balanced randomization scheme was developed in advance, and subjects were assigned to a treatment sequence at enrollment.
729744|NCT01813071|Participants in general good health were recruited, screened and consented at the icddr,b Dhaka in Bangladesh. Final eligibility was determined by fulfillment of all the inclusion and absence of any of the exclusion criteria. Adults were enrolled August 23, 2013 to November 10, 2013 and children were enrolled April 27, 2014 to August 9, 2015.|
729745|NCT01813058||
729746|NCT01813019||
729747|NCT01812837||
729748|NCT01812759|Cancer patients presenting to the M. D. Anderson Cancer Center Emergency Department for treatment of acute breakthrough pain, who met study inclusion criteria.|The first patient's primary physician admitted the patient to the hospital after the patient consented to the study but before the patient received any medication.
729749|NCT01812707|The study was conducted at 4 centers in Japan. Overall, 162 participants were screened between March 2013 and August 2013, 62 of whom were run-in/screen failures, mainly due to exclusion criteria met.|Randomization was stratified according to atorvastatin dose. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1 ratio after confirmation of selection criteria. 100 participants were randomized.
729757|NCT01811940||169 individuals enrolled in the trial and entered a 1 week placebo lead-in. 42 participants were not randomized due to several reasons including 16 being considered to be placebo-responders and 18 being lost to follow-up. 127 participants were then randomized.
729758|NCT01811732||
729759|NCT01811706||
729760|NCT01811693||
729761|NCT01811680||
729762|NCT01811654||
729763|NCT01811563|60 patients signed consent form but 12 were withdrawn at the time of surgery because they required a different implant not included in the study.|
729764|NCT01811485||
729765|NCT01811472||
729766|NCT01811355||Of 28 patients who signed consent, 5 did not meet inclusion criteria because of past myocardial infarction (n=1), long QT syndrome (n=1), AV block (n=1), no muscle cramps (n=1), and hospitalization during the screening period that resulted in inability to complete a screening diary and follow-up (n=1) .
729767|NCT01811316||
729768|NCT01811303|Recruitment of adults volunteers done by RSSL, in Reading (United Kingdom), under GCP.|There was 15 subjects screened that all were complying with the eligibility criteria. Finally only 14 subjects were involved in the study and analysed as far the study was planned to involve 12 subjects. All 14 subjects received the treatment randomized to a William's Latin square design balanced for treatment order.
729769|NCT01811238|The 10 general hospitals were recruited patients from 26 Sep. 2012 to 02 Aug. 2013.|
729770|NCT01811225||
729771|NCT01811212|Between September 2013 and January 2015 patients were enrolled by ITOG investigators at six centers in the United States.|
729772|NCT01811186|Safety set: 261 patients were enrolled. ITT set was 258, 3 patients of the 261 patients deviated from inclusion/exclusion criteria.|
729773|NCT01811147||After enrollment 3 subject were excluded form the study since it was later discovered that they did not meet the criteria.
729774|NCT01811030||
729775|NCT01810991||
729776|NCT01810952|Participants were identified from admission listing of patients and admitting diagnoses. Admitting physician was contacted to determine eligibility and if s/he were agreeable to our approaching patient regarding the study. Protocol was explained to patient. If s/he agreed to participate, they were asked to sign an informed consent.|
729777|NCT01810939||
729778|NCT01810783||
729779|NCT01810692||
729780|NCT01810666|Subject recruitment period was between 20-Mar-2013 to 28-Jun-2013.|Of 33 participants who were screened for inclusion in the study, 30 were enrolled and received treatment.
729781|NCT01810432||
729782|NCT01810380||
729783|NCT01810302||
729784|NCT01810289||
729785|NCT01810263|"first ever stroke
~MRI confirms his/her stroke
~weight loss over 2.5% within 2 weeks after the stroke onset
~MMSE >= 10
~medically stable"|
729786|NCT01810042|Total 53 patients were screened and 49 patients were enrolled from Oct 2010 to Feb 2013 in Pusan National University Hospital and Inje Baik Haeundae Hospital.|This study has a single arm, and there was no assignment process.
729787|NCT01810016||
729788|NCT01809938|Recruitment took place from november 2011 until january 2012 at St Thomas' Hospital, London|
729789|NCT01809899|12 participants were recruited, but we were unsuccessful in recruiting sufficient number of non-PTSD, but trauma exposed patients.|
729790|NCT01809834||Two participants were determined to be ineligible at the screening visit due to their level of astigmatism
729791|NCT01809639||
729792|NCT01809327|The study was conducted between 16 May 2013 and 01 December 2014 and recruited participants from 158 study centers in 12 countries worldwide.|A total of 1,186 participants were randomly allocated to the 5 treatment arms. All participants received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set.
729793|NCT01809314||
729794|NCT01809262|A Pharmacokinetic sub-study to characterise the pharmacokinetics of 2 μg to 20 μg Olodaterol was planned in a subset of 18 patients. After preliminary evaluation of the data, an open-label extension was planned to investigate the safety, tolerability, and pharmacokinetics of single doses of 40 μg Olodaterol in the 18 patients of the PK sub-study.|This was a randomised, Double-Blind, Placebo-Controlled, 5-Way crossover trial. Each treatment was only administered once in a single dose with a washout period of at least 14 days between treatments.
729795|NCT01809210|Patients were enrolled into dose-finding cohorts to evaluate escalating doses of selumetinib (AZD6244; ARRY-142886) to determine the maximum tolerated dose in combination with standard first-line chemotherapy regimens. Chemotherapy was administered on Day 1 (and Day 8 for gemcitabine) of each 3-week cycle.|Data cut off (DCO) was 7 Jan 16. DCO was defined as the earliest of 12 (±1) weeks after last patient started, or 28 days after final patient discontinued, selumetinib or chemotherapy doublet regimen.
729796|NCT01809197|Subjects were recruited from 22 study sites located in the US.|Of the 387 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (372).
729797|NCT01809132||
729798|NCT01809106|Date of First Enrollment: May 2014 Date of last enrollment: July 2014|
729799|NCT01809054||
729800|NCT01808963|Recruitment from 12/19/12 through 5/31/13 in the UCDMC Peri-operative Suite.|
729801|NCT01808950||
729802|NCT01808794||The Study PI has passed away. All efforts to locate study data have been exhausted and there is no study data available
729803|NCT01808755|60 female patients aged between 22 and 74 years were visited at the outpatient Clinic (July 2011-July 2012), they were eligible for study if they were 18 years old or older and had 3 or more culture documented urinary tract infections (UTI) in the preceding 12 months. Women were excluded from study if they had evidence of upper UTI|All patients before entering the trial were prescribed and followed a regimen of continuous, low-dose daily antibiotic prophylaxis at bedtime or post-coital prophylaxis with cotrimoxazole or ciprofloxacin, whenever the UTI occurred 24-48 hours after intercourse.
729804|NCT01808690||Three (3) enrolled participants decided against participation in the study before randomization occurred.
729918|NCT01801124|Recruitment occurred between 20 July 2012 and 27 November 2012.|Subjects were not excluded.
730796|NCT01739764|The study was conducted at 82 centers in 24 countries.|215 participants were enrolled into this OLE study and were included in the Safety population.
729805|NCT01808651||This study consisted of 2 study periods for Japanese participants who completed acute treatment in Study B1Y-JE-HCLV(NCT#: NCT01808612): Study period I was a 52-week open-label treatment period with fluoxetine 20 to 40 milligrams (mg), administered once daily, and Study period II was a 2-wk observation phase following discontinuation of fluoxetine.
729806|NCT01808612||This study consisted of 3 periods: a single-blind screening period (1 week of placebo), a double-blind short-term treatment period (1 week of placebo followed by randomization in a 2:1:3 fashion to 20 milligrams [mg] fluoxetine, 40 mg fluoxetine, or placebo, respectively, for 6 weeks), and a single-blind discontinuation period (2 weeks of placebo).
729807|NCT01808573||
729808|NCT01808560||
729809|NCT01808547||
729810|NCT01808534|This protocol was based on a two stage design, getting 12 patients at the first stage and 8 more if at least one CR or PR was observed in the first 12. Due to low accrual, the study was stopped at 5 patients for this study.|
729811|NCT01808508|Children were recruited from The Children's Hospital of Philadelphia Trisomy 21 Program and community support groups.|27 subjects were consented, 4 subjects were ineligible before randomization. Subjects with an obstructive apnea hypopnea index (AHI) of at least 5/hr were randomized to CPAP or sham CPAP (Group 1 or 2) for 4 months in a double-blind fashion. Subjects with normal baseline polysomnograms (AHI <1.5/hr) were followed without CPAP (Group 3).
729812|NCT01808339|Participants meeting eligibility criteria at the Screening visit entered a 2-week Run-in Period for Baseline safety evaluations and to obtain measures of asthma status.|Participants meeting randomization criteria were enrolled in the study for 13-18 weeks: three 14-day treatment periods separated by a 14- to 21-day washout period, followed by a follow-up visit within 7-14 days of the last dose.
729813|NCT01808326|This study consisted of three phases: Screening Phase (within 6 weeks prior to Day 1), Treatment Phase (up to 48 weeks) and Follow-up Phase (up to 24 Weeks).|Participants with Chronic Lymphocytic Leukemia (CLL) were enrolled after blood sampling, physical examination, and Computed Tomography (CT) scan. The physical examination was performed <=14 days prior to Visit 2, CT scan performed within 6 weeks and the bone marrow examination within 6 weeks prior to Day 1.
729814|NCT01808313||A total of 134 participants were enrolled and received at least one dose of study medication. 133 participants comprised the Intent-to-Treat (ITT) Population (all participants that received at least one dose of study treatment and had an efficacy assessment performed both at Baseline and after administration of the study treatment).
729815|NCT01808261|A total of 134 participants with Stroke, were randomized to the study. The study was conducted from 18 May 2013 to 28 July 2014 at 30 centers; with 5 in United States, 5 in Canada, 8 in United Kingdom, and 12 in Germany. The ITT population consisted of total 120 participants and the Per Protocol consisted of 104 participants.|Screening details: This study consisted of a 6 month Core study period and an Extended follow Up period, if required. The study was terminated early at the time of Interim Analysis for reasons of futility. At that time, a total of 134 participants were randomized, of which 133 participants had received at least one dose of study medication.
729816|NCT01808248|Participants were enrolled at a single site in the United States. The first participant was screened on 18 February 2013. The last participant observation occurred on 06 December 2013.|56 participants were screened; 47 participants were enrolled and treated, and comprise the Safety Analysis Set and the Full Analysis Set.
729817|NCT01808222||
729818|NCT01808209|Sixty habitual contact lens wearing subjects were recruited by the Optometry Clinic at Aston University|All subjects were habitual lens wearers and were randomized to each pair of study lenses. Only one patient failed to complete all study visits and their data was excluded from the analysis.
729819|NCT01808196||
729820|NCT01808144|Subjects entered this extension Study RDEA594-307 while the core Study RDEA594-304 was ongoing and the database was not yet locked. To maintain the blind of the core study for subjects entering the extension, the lesinurad dose for all subjects in this extension study was blinded to the Sponsor until database lock of Study RDEA594-304.|Subjects randomized to lesinurad (RDEA594) 200 mg or 400 mg + febuxostat (FBX) 80 mg in Study RDEA594-304 continued to receive the same dose in this study. Subjects randomized to placebo + febuxostat 80 mg in Study RDEA594-304 were randomized in a double-blind, 1:1 fashion to either lesinurad 200 mg or 400 mg + febuxostat 80 mg.
729821|NCT01808118||This study included a 42-day screening period.The Full Analysis Set (FAS) included all participants who enrolled in the open-label period (Period 1) and received at least 1 dose of adalimumab. The All Randomized Set included all Period 2 participants who were randomized to receive either placebo or 40 mg adalimumab every other week.
729822|NCT01808092|Overall, 879 patients were randomized in this study, from 4 geographic regions. The first patient was enrolled on 13 April 2013 and the last patient last visit was on 07 January 2016. Summary tables exclude 62 patients with moderate/severe renal impairment recruited prior to a protocol amendment to the dose regimen for such patients (MSRIBorig).|The first patient was enrolled on 13 April 2013 and the last patient last vist was on 07 January 2016. Overall, 969 patients were enrolled in this study, 90 of them screen failures.
729823|NCT01808066||
729824|NCT01807949||
729825|NCT01807923||
729826|NCT01807871|Recruitment between April 2013 and July 2015|
729827|NCT01807650|Participants were enrolled from 04 Apr 2013 to 04 Sep 2013 in 14 clinical centers in 4 countries: Spain (6 centers), Greece (3 centers), Latvia (2 centers), and France (3 centers).|113 participants were screened and wound halves of 112 participants were randomized and treated. For one participant, wound halves were neither randomized nor treated because the split-thickness skin graft surgery was cancelled. Overall, 112 wounds in 112 participants were treated.
729828|NCT01807637|Subjects were recruited via study advertisements and referrals from physical therapy clinics|
729829|NCT01807624||
729830|NCT01807598||
729831|NCT01807585|The VeClose pivotal study was a prospective, multicenter, randomized, controlled study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either VenaSeal SCS or radiofrequency ablation (RFA) therapy. Patients were treated between March 2013 and September 2013. There were 10 sites with 242 subjects.|"The VeClose study had two phases: a roll-in phase and a randomization phase. At each site, the first two enrolled subjects were treated with VenaSeal SCS only (no randomization) as roll-in cases. Following completion of the roll-in phase, the site entered the randomized phase where subjects were assigned to either VenaSeal SCS or RFA cohort."
729832|NCT01807520|The study was made up of 4 periods: screening, treatment period 1, treatment period 2 and post-treatment follow-up.|In treatment period 1, participants were randomized in a 1:1:1 ratio to secukinumab 150mg, secukinumab 300mg or placebo. In treatment period 2, placebo participants were re-randomized in a 1:1 ratio to secukinumab 150mg or secukinumab 300mg. The follow-up period occurred 8 weeks post treatment period 2 (12 weeks post the last dose of secukinumab).
729833|NCT01807455||
729834|NCT01807299||
729835|NCT01807234||
729836|NCT01807156||
729837|NCT01807104||
729838|NCT01807065||
729839|NCT01807026||
729840|NCT01807000||
729841|NCT01806961||
729842|NCT01806896||
729843|NCT01806857||90 subjects were consented for this trial, however, of the 90 that consented, 30 subjects were found to not meet eligibility criteria, and therefore were not treated.
729844|NCT01806779|Recruitment began on 3/4/2013 and ended on 9/7/2014. Of the 376 subjects (subjs.) consented during this period, 197 subjects met all study criteria.|Of the 376 subjs. enrolled, 179 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1). 197 subjs. met all study criteria, attended V1 & given NRT for 1 week; 176 subjs. attended V2 & completed SE quest.; 2 subjs. dropped out during this visit before randomization; 174 subjs. randomized.
729845|NCT01806740|"Despite several extensions of the recruitment period, the planned number of enrolled patients was still not reached after 2 years and the study was prematurely discontinued.
~A total of 37 patients were enrolled in four study sites."|
729846|NCT01806714|4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers|For this study, there was a waiver of consent; 4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers.
729847|NCT01806675||
729848|NCT01806662||
729849|NCT01806623||
729850|NCT01806597|Week 16 was considered the first dose of Treatment Period 2. Week 132 visit was the final visit of Treatment Period 2, and no study treatment was administered at this visit.|Patients who completed Period 2 & patients who prematurely discontinued treatment or withdrew from study entered the treatment-free Follow-up (FU) Period (no study treatment was administered during Period) included only 1 visit at Week 140 (End of FU), which was 8 weeks after the end of Period 2 & 12 weeks after the last dose of study drug.
729851|NCT01806584||
729852|NCT01806571||
729853|NCT01806545||
729854|NCT01806506|The patients were recruited from the population of patients referred for bariatric consultation to the outpatient clinic of the Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Poland. The recruitment started in November 2008 and finished when the planned number of patients had been recruited for the study.|Eighty six patients meeting the general criteria for bariatric surgery were evaluated for eligibility for the study. Six patients did not meet eligibility criteria (age > 60 years in 5 patients, suspicion of malignancy in 1 patient) and 8 patients decided not to participate in the study.
729855|NCT01806389|Subjects were recruited from a study evaluating fetal and infant effects of maternal buprenorphine treatment|Fourteen women were consented for this protocol but 4 were withdrawn for various reasons, i.e. inability to provide samples, changed mind about breastfeeding.
729856|NCT01806298||
729857|NCT01806259||
729858|NCT01806064|23 patients enrolled in phase 1b portion. 150 patients randomized in the phase 2 portion.|
729859|NCT01806051|No data was collected because all of the participants who consented to participate in the study withdrew due to the procedural challenges of remaining in the study (e.g. the PM blood draws were too disruptive).|
729860|NCT01805895||
729861|NCT01805882||
729862|NCT01805791||
729863|NCT01805687||
729864|NCT01805440||
729865|NCT01805323||
729866|NCT01805297||
729867|NCT01805180|Subjects were recruited from the specialized donor population of blood centers from February 2013 - July 2013.|A screening period was used to evaluate and confirm eligibility criteria prior to enrollment & randomization to treatment assignment (Arm 1 or Arm 2). Fifty subjects consented to the pivotal study. Eight pivotal subjects consented but screen failed prior to treatment assignment. Forty-two received treatment assignment below.
729868|NCT01805154||
729869|NCT01805089||
729870|NCT01805024||
729871|NCT01804946||
729872|NCT01804881||
729873|NCT01804842||
729874|NCT01804816|Participants were recruited from the Cleveland Clinic Heart and Vascular Institute section of Heart Failure and Transplant Medicine.|All subjects acted as their own controls for this study and were assigned to a 5 week period of no acupuncture or other study interventions (control) followed by a 5 week period of weekly standardized verum acupuncture (intervention).
729875|NCT01804673||
729876|NCT01804582||
729877|NCT01804257||
729878|NCT01804140||
729879|NCT01804101||
729880|NCT01804075||
729881|NCT01804062||
729882|NCT01804049|Participants were recruited via advertisement flyers, primary care referral and letters to subjects in the research data warehouse within the Portland VA Healthcare System between May 2014 and August 2015. The first participant was enrolled in the study on May 27,2014 and the last participant was enrolled on August 12, 2015.|Of the 431 assessed for eligibility, 120 met inclusion criteria and were randomized to treatment.
729883|NCT01804036||In Mind-Body Bridging, 41 participants consented, but one participant did not provide baseline assessment data; consequently, 40 Mind-Body Bridging participants' baseline data were included in the analyses.
729884|NCT01803880|There were 148 subjects who initially signed a consent form, although 72 subjects withdrew consent prior to starting the study. This resulted in only 76 subjects actually starting the study and proceeding with study treatment.|Part I required all qualified investigators to perform 1 to 3 procedures using the study devices for the purpose of minimizing variability with the recommended directions for use established in the instructions for use. Part I subjects were to be included in the safety population only.
729885|NCT01803737|We recruited twenty six (N=26) sedentary, overweight and obese adult men and women to participate in a behavioral weight loss intervention at the University of Pittsburgh Physical Activity and Weight Management Research Center. Recruitment occurred between January 2013 and March 2013.|
729886|NCT01803711|A total of 30 subjects underwent phone screening. Of these, a total of 6 subjects were consented and 5 met study eligibility criteria.|One subject who was consented did not meet the threshold for depression symptomatology during screening as determined by the Hospital Anxiety and Depression Scale.
729887|NCT01803646|A total of 86 sites were initiated in Canada, the United States, the Czech Republic, Israel, Turkey and Republic of South Korea. In total, 69 sites screened each at least 1 subject and 64 sites randomized subjects for treatment.|"A total of 478 subjects were screened, 343 subjects were randomized, and 336 subjects were treated. 7 subjects were randomized (3 to AM-101 and 4 to placebo) but not treated; these subjects were excluded from the analysis sets.
~The majority (92%) of subjects completed the study."
729888|NCT01803607|Postmenopausal female participants ≥60 years of age with low bone mineral density (BMD) and who had been treated with an oral bisphosphonate for at least 3 years were recruited at 81 sites in the United States.|The Sponsor made a business decision to terminate the trial early due to poor enrollment; the decision was not related to any findings regarding the efficacy or safety profile of odanacatib.
729889|NCT01803464|62 children with spastic cerebral palsy eligible for botulinum toxin treatment and typically developing children were screened. 5 children did not meet the study criteria and 57 children were invited to participate in the study, of which 29 participated in the study.|
729890|NCT01803282|Participants were enrolled at study sites in the United States. The first participant was screened on 29 March 2013. The last study visit occurred on 23 April 2019.|280 participants were screened.
729891|NCT01803269||
729892|NCT01803204|For the pilot study and testing of the evaluation printed were contacted 8 patients as intervention group and control group not applied.|
729893|NCT01803074|The study was conducted at 3 centers in 3 countries (1 in Germany, 1 in the United Kingdom, 1 in South Africa) from 04-April-2013 to 29-November-2014.|Participants screened were 191 of which 84 were screen failures (Participant withdrew consent: 3, Pregnancy: 3, Participant no longer meets study criteria: 73, Not according to participant's schedule: 1, Not included since cohort was closed: 3 and back up participant: 1). Only 107 participants (Part A: 60; Part B: 28; and Part C: 19) were enrolled.
729894|NCT01802879||There was no screening period. Patients enrolled into trial directly from the parent protocol.
729895|NCT01802775||A total of 275 subjects were screened, of these 203 subjects were randomized into the study, with 101 subjects in the edoxaban group and 102 subjects in the clopidogrel group.
729896|NCT01802710||
729897|NCT01802632|Patients recruited to different cohorts. Dose escalation cohort of pre-treated patients in 5 dose groups. Dose expansion cohort (pre-treated) in same 5 dose groups. First line patient cohort. 80mg tablet cohort of pre-treated patients. Japan-only cohort (EGFR T790M+ by cytology). Phase II extension cohort in pre-treated EGFR T790M+ patients.|603 patients were enrolled and received treatment.
729898|NCT01802580||
729899|NCT01802554||
729900|NCT01802515|Adult male and female participants were recruited from the Greater New Haven area from September 2012 to January 2014 by word-of-mouth, flyers and from referrals from treatment centers in the local area. The study was conducted in an outpatient clinic of the West Haven VA Hospital.|After eligibility was determined, participants were randomized to placebo, 40 mg atomoxetine or 80 mg atomoxetine. The study consisted of 3 phases 1) a two-week methadone induction phase 2) an 8-week treatment phase and 3) a 4-week taper and detoxification or transfer phase.
729901|NCT01802437||
729902|NCT01802411||
729903|NCT01802385||
729904|NCT01802333||
729905|NCT01802320|Recruitment Period: March 07, 2013 to July 14, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|
729906|NCT01802216|This study enrolled English and Spanish-speaking patients 20-75 years old receiving primary care within the San Francisco Community Health Network. Patients with chronic kidney disease, not on dialysis, and moderate to severe periodontal disease are invited to participate.|Participants are assigned in a 2:1 ratio to control or intensive treatment group, randomization is stratified by presence of diabetes. Enrollment began February 2014 until September 2016. 101 participants attended the in-person oral exam screening. 55 were randomized, 46 were excluded (41 did not meet periodontal disease criteria and 5 declined.
729907|NCT01802151|Healthy adults were recruited by flyers and word of mouth on the University of Florida campus. Rolling recruitment (7/02/2012-08/23/2012) occurred until the minimum number of participants (n=80) had been enrolled.|A one week baseline period was to be completed before participants were randomized to intervention arms. Participants that failed to complete study requirements during this period were withdrawn due to noncompliance.
729908|NCT01802073||Two participants in the adult cohort completed the study but were not analyzed for outcomes (1 post-liver transplant patient; 1 completed the study but followed a diet that could influence results analysis). Two adult participants who consented but withdrew prior to treatment were not analyzed for outcomes.
729909|NCT01801982|All participants who received sildenafil treatment during study A1481276 (NCT01069861) were eligible for enrollment in this study.|
729910|NCT01801917||
729911|NCT01801865||The attending neonatologist determined whether the MRI scan was done with or without sedation. If possible, infants were scanned without sedation. Infants were prepared for the MRI exam by switching all monitoring devices over to MRI compatible monitors and provided with hearing protection.
729912|NCT01801735||
729913|NCT01801475||
729914|NCT01801449||
729915|NCT01801436||
729916|NCT01801358|The CMEK162X2203 study began recruitment on 26-Aug-2013 and concluded on 15-May-2015. Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.|"Participant Flow and Baseline Demographics data represents the Full Analysis Set (FAS), which includes all patients who received at least one full or partial dose of sotrastaurin or binimetinib.
~Not completed subjects represents subjects that stopped treatment early, due to the corresponding reason."
729917|NCT01801280|Recruitment lastet between January 2012 - March 2013.|
730797|NCT01739595||
729919|NCT01801111|Overall study status was confirmed as completed. Here, 'study terminated by sponsor' in reason for study not completed means participants were transitioned to commercial supply of alectinib (where it was available) or transitioned to a roll-over study BO39694 (NCT03194893) where they continued to receive alectinib treatment.|Part 1 of study was planned to determine recommended Phase 2 dose (RP2D) of alectinib to be used in Part 2. During the conduct of Part 1 for this study, RP2D was confirmed in Study NP28761 (NCT01871805). Hence Part 1 participants were merged into Part 2. Part 3 was post-progression treatment period.
729920|NCT01801007||
729921|NCT01800968||
729922|NCT01800916|Recruitment was performed primarily via Coloplast own subject database. In Norway recruitment also took place through medical clinics and hospitals.|65 participants were recruited. However, one participant was a screen failure and was not randomized and did not try any products.
729923|NCT01800903||"40 subjects were included in the safety population. 4 subjects discontinued because they were unable to catheterize with given catheter. these drop-outs were distributed evenly among the catheter types:
~subject: ZN-C
~subjects: ZN-D
~1 subjects: SC
~These subjects were excluded from the ITT population as no endpoints were registered for them"
729924|NCT01800890|The subject were recruited through the Coloplast user data base.|Thirty-one subjects signed the informed consent, but 2 subjects were screen failures and did not test any products. These two subjects are not included in the participant flow below.
729925|NCT01800877|From April 2013 to August 2014, intensive care units (ICUs) at 11 academic hospitals in Canada and the USA participated in this open-label randomized controlled trial with approval from their local research ethics boards.|
729926|NCT01800838|This study recruited patients between April 2013 and April 2015 at Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
729927|NCT01800786||
729928|NCT01800318|Dates of recruitment: 4/10/2013 until 12/31/2014. Types of location: Postpartal/newborn units at University of Arkansas for Medical Sciences and Lucille Packard Childrens Hospital associated with Stanford University.|All infants enrolled in the study were assigned to groups.
729929|NCT01800201|Participants were recruited by University of Pennsylvania research staff from March 2013 through January 2015 and followed for one year.|No enrolled participants were excluded from the study before arm assignment
729930|NCT01800162|Recruitment for the study has closed at both study sites, The University of Pennsylvania and Greenville.|"Subjects must be 18 years or older. Subject must have a positive pregnancy test but no signs of pregnancy visualized in the uterus or adnexa on ultrasound? Subject must have at least three serial hCG values over the past 4-14 days or two serial hCG values over the past 7-14 days.
~Subject must be hemodynamically stable with a hemoglobin >10mg/dL."
729931|NCT01800058|66 patients included: 2 patients were not included in the final enrollment due to inegibility criteria|
729932|NCT01799993|To shorten the time required to obtain data from the 2 clinical studies of Amikacin Inhale Phase 3 program, Bayer and the FDA decided that the results of studies NCT01799993 and NCT00805168 should be consolidated into a single report. The studies were conducted at 166 centers across 25 countries, between 13 APR 2013 (FPFV) and 07 APR 2017 (LPLV).|A total of 807 participants were screened, of which 725 participants were randomized for the 2 studies (264 for NCT01799993 and 461 for NCT00805168), 712 participants were treated with study treatment per exposure data in EDC; 354 received aerosolized amikacin inhale and 358 received placebo.
729933|NCT01799941||A total of 394 participants were screened of which 367 participants were enrolled in the study; 134 in the dementia cohort, 113 in the stroke cohort, and 120 in the traumatic brain injury (TBI) cohort.
729934|NCT01799889|Participants were enrolled at study sites in United States and Canada. The first participant was screened on 14 March 2013. The last study visit occurred on 30 January 2020.|444 participants were screened.
729935|NCT01799720|The place where women were recruited for our study was a pharmacy located in the city centre of Elche, during October 2010. Elche is an industrial city located in the Southeast of Spain, with a population of 230 000 inhabitants.|"Before the survey began, 14 people were discarded from the survey because their cholesterol levels were lower than the inclusion standards.
~5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled."
729936|NCT01799590|Present study is continuation of previous study (JNS019-JPN-02, NCT01081795). The participants who completed the previous study or the cases where the administration of study drug was discontinued because of insufficient results were enrolled in this study.|
729937|NCT01799278||
729938|NCT01799239|The subjects were recruited from hospital sites in Sweden and in Germany subjects were recruit from the Coloplast database and from hospital sites.|The investigation was designed as a cross-over study where subjects that did not complete the 1 period as planned were allowed to continue to the next test period.
729939|NCT01799226||"Initially 15 participants were sought for each arm, but when two were withdrawn from the control arm, two more participants were recruited and randomized, one to each arm. So total start on each arm was 16.
~The Disqualification noted below for one participant was because s/he no longer met inclusion criteria as of day 14."
729940|NCT01799213||490 participants were enrolled and underwent the run-in; 364 (74%) participants remained eligible at the end of the run-in period and were randomized: 180 to placebo followed by CBT and 184 to meloxicam.
729941|NCT01798992|Patients were recruited between 9/1/2000 and 3/1/2008 from outpatient general cardiology and heart failure specialty clinics at the University of Colorado Hospital and University of Utah Health Sciences Center.|65 patients met screening criteria and provided consent. Exclusions included personal preference (4), administrative reasons such as relocation (2), normalization of LVEF prior to assignment (2), and lack of central venous access (1).
729942|NCT01798966||
729943|NCT01798927||
729944|NCT01798849||In Panels A and B, 8 healthy male participants alternately received single rising doses of MK-8892 or placebo.In Panel C, 8 mild to moderate hypertensive male participants received single rising doses of MK-8892 determined by results of Panels A and B or placebo. Each period in a panel was separated by a 7-day washout.
729989|NCT01796236||106 subjects signed informed consent. Before surgery one subject cancelled surgery, one subject withdraw consent and one subject got the wrong allocation due to logistic problems. This resulted in that 103 subjects received the allocated intervention (51 test and 52 control).
729990|NCT01795937||
729945|NCT01798706|The study was conducted at 83 centers in 13 countries. A total of 786 participants were screened between June 10, 2013 and July 09, 2014.|A total of 426 participants underwent 4 week placebo run-in period. 436 participants were screen failures and 76 were run-in failures; the most frequent reason for screen and run-in failure was glycosylated hemoglobin (HbA1c) criteria not met at end of the run-in phase. A total of 350 participants were randomized.
729946|NCT01798641||10 patients (5 from each group) were excluded from the study as further assessment prior to randomization showed significant risk of falls
729947|NCT01798589||
729948|NCT01798550||
729949|NCT01798485|209 sites screened at least one patient and 175 sites randomized at least one patient.|"1220 patients with advanced NSCLC of adenocarcinoma histology diagnosed ≥6 months prior to study entry were screened. 696 patients were randomized in a 1:1 ratio to two arms and stratified by:
~ECOG (0 versus 1)
~Screening total LDH levels (normal vs. elevated)
~Geographic region (North America and Western Europe vs. Rest of World)"
729950|NCT01798394||
729951|NCT01798316||
729952|NCT01798264|Initiated February 2009 completed 15 May 2009|
729953|NCT01798225|Recruitment period from 12/18/2007 to 01/12/2010. Recruitment happened from previous studies and community events.|
729954|NCT01798186||Participants were randomized to 3 experimental sessions. Additionally, participants were recruited to smoke cannabis in order to generate the smoke that was passively inhaled by the experimental groups.
729955|NCT01798134||
729956|NCT01798056||Out of the 237 subjects initially enrolled in the study, only 232 subject were included in the Total Vaccinated Cohort.
729957|NCT01798004||
729958|NCT01797965|Participants were enrolled in the study at 226 investigative sites in 28 countries (United States, Canada, Western European countries, Australia, Israel, Eastern European countries, Argentina, Brazil, India, and Mexico) from 15 February 2013 to 24 September 2018.|Participants who completed studies: 205MS301 (NCT01064401), 205MS203 (NCT01051349), 205MS302 (NCT01462318) were eligible to enroll in this long-term extension study.
729959|NCT01797835||this study included an examination of screening; thus, not all youth were part of the randomized controlled trial as they screened in at low risk. This is why there is a larger N for the overall sample. The 294 are the youth that screened in as at-risk who were then part of the RCT.
729960|NCT01797822||
729961|NCT01797783|Participants were recruited from 9 study centers located in the United States.|Of the 83 consented participants, 2 were exited as screen failures prior to randomization, and 2 were exited after randomization but prior to product dispense. This reporting group includes all randomized participants who were dispensed study product (79).
729962|NCT01797731||
729963|NCT01797705||
729964|NCT01797575||Patients were randomly assigned to one of the four arms during weeks 0-8. For patients who did not respond to treatment in period one, they were re-randomized to one of the other three arms and received a drug they had not yet received during period one. 8 were re-randomized to a different arm during period two.
729965|NCT01797562|Subjects will be recruited from patients visiting dermatology, allergy or similar medical practices and clinics, and who are likely to require diagnostic patch testing. Study subjects must be otherwise healthy, and fulfill entry criteria.|Entry criteria required avoidance of systemic or topical (near the test area) corticosteroid treatment during the 7 days prior to patch application, and any treatment with UV light for 3 weeks prior to patch application.
729966|NCT01797536||3 participants from the mild insufficiency arm were mistakenly reenrolled into the moderate arm and received a 2nd single dose of study drug. Data for these 3 participants were excluded from pharmacokinetic analysis of the moderate arm but were included in the safety analysis. An additional 3 participants were enrolled in the moderate arm.
729967|NCT01797484|"first patient enrolled: 05-Aug-2013 last patient finished: 05-Jun-2015
~All patients were enrolled at University Heart Centre Hamburg Eppendorf"|
729968|NCT01797471||
729969|NCT01797458|Patients were recruited between 2011 and 2012 from the Preventive and Paediatric Dentistry Department of Greifswald University, Germany.|After initial screening from daily patient lists, 181 children were assessed for eligibility from the Preventive and Paediatric Dentistry Department of Greifswald University, Germany. 12 children were initially excluded due to reported systemic diseases, refused to participate, etc.
729970|NCT01797445|Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 March 2013. The last study visit occurred on 03 October 2018.|1070 participants were screened.
729971|NCT01797380||
729972|NCT01797328||
729973|NCT01797302||
729974|NCT01797263||
729975|NCT01797185||
729976|NCT01797159||
729977|NCT01797120|A total of 131 patients were enrolled from 23 institutions between May 2013 and November 2015.|
729978|NCT01797094||
729979|NCT01797081||
729980|NCT01797029||
729981|NCT01796977||
729982|NCT01796964|Subjects were recruited from 41 investigational centers located in the US.|Of the 173 enrolled, 83 subjects were exited as screen failures prior to randomization. One randomized subject did not receive treatment. Another subject randomized to ESBA 1008 received EYLEA treatment. This reporting group includes all randomized and treated subjects, as treated (ESBA1008: 44 subjects and EYLEA: 45 subjects).
729983|NCT01796912||
729984|NCT01796860||
729985|NCT01796548||
729986|NCT01796470|Participants were enrolled at study sites in the United States. The first participant was screened on 20 June 2013. The last study visit occurred on 22 December 2016.|85 participants were screened.
729987|NCT01796392||
729988|NCT01796301|The study was conducted at 46 sites in North America, Latin America, and Europe. Participants were enrolled from 31 January 2013 to 29 April 2014.|A total of 777 subjects were screened for participation; 341 (43.9%) were excluded prior to randomization, primarily due to not meeting inclusion/exclusion criteria (306 [39.4%] subjects). A total of 436 participants were randomized into the study.
729991|NCT01795898||
729992|NCT01795859|A total of 90 subjects were randomized 1:1 to receive either SD-809 or placebo. All subjects were assessed for capacity to provide informed consent and written informed consent was obtained appropriately|
730000|NCT01794949|Participants were selected from patients with acute coronary syndrome (ACS) presenting to Emory University Hospital Midtown for coronary angiography. Participants were recruited between September 2013 and September 2015.|Of the 24 individuals who signed the consent form, 16 were found to be ineligible to participate in the study, resulting in 8 participants who started the trial.
730001|NCT01794936|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.|
730002|NCT01794845||
730003|NCT01794806||
730004|NCT01794780|A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.|
730005|NCT01794741||
730006|NCT01794702|Recruitment Period: 1/2013 to 01/2018|"All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol.
~Period 1: Dose level 1 - Clofarabine 15mg/m^2 daily x 4 days (days 6-9) Period 2: Dose level-1 - Clofarabine 15mg/m^2 daily x 3 days (days 6-8)"
730007|NCT01794689|During screening for the study we evaluated whether participants were generally healthy, pain free, and good sleepers. We screened 255 to obtain 100 participants who met criteria and were randomized to the experimental portion of the study. The experimental phase occurred at an inpatient clinical research unit.|
730008|NCT01794455||
730009|NCT01794312||
730010|NCT01794039||
730011|NCT01794000||
730012|NCT01793935||
730013|NCT01793909||
730014|NCT01793883||
730015|NCT01793792||
730016|NCT01793688||A total 986 subjects were registered in this study. Of the 986 subjects, 982 subjects CRFs were collected and included in the study.Of the 982 subjects, 2 subjects were excluded from the safety analysis set (SAS). In total, 980 subjects were included in the SAS as the completed the study.
730017|NCT01793610|Candidates were recruited via Internet advertisements and referrals from mental health professionals. Potential participants were men and women 18 years or older. Inclusion criteria required PTSD for at least six months. The study was conducted at an outpatient clinic in Boulder, Colorado between October 2012 and February 2017.|One participant was excluded for not meeting eligibility criteria after enrollment prior to randomization.
730018|NCT01793285|Participants who completed the LoadET study 0881A3-102090 (NCT00873730), were eligible for this study.|
730019|NCT01793142||
730020|NCT01792986||
730021|NCT01792830|Participants were recruited from Emory University Hospital, Emory University Hospital - Midtown, and Grady Memorial Hospital, in Atlanta, Georgia, from October 2012 to February 2014. Study arms for results are presented to precisely reflect the medication used post-hospital discharge, as prescribed by the participant's provider.|
730022|NCT01792817||
730023|NCT01792635||
730024|NCT01792518|360 patients were randomised and treated (Placebo: 178 patients, Linagliptin: 182 patients.)|Randomized, double-blind, placebo controlled, parallel group study to evaluate glycemic and renal efficacy of once daily administration of Linagliptin 5 milligram (mg) for 24 weeks in type 2 diabetes patients, with micro- or macroalbuminuria on top of current treatment with Angiotensin Converting Enzyme inhibitor or Angiotensin Receptor Blocker
730025|NCT01792284||Participants completed a 12 week (wk) Lead-in Period during which insulin peglispro was administered at fixed time in the evening. Participants were then randomized to a fixed evening dose regimen or a variable time dose regimen for 12 wks (Randomization Period 1); after 12 wks, they crossed over to the alternate regimen (Randomization Period 2).
730026|NCT01792115||
730027|NCT01792024||
730028|NCT01791972||A total of 64 patients with EIB were screened. Of the 26 patients who did not participate in the study, 23 were excluded on the basis of inclusion/exclusion criteria, 2 patients withdrew consent, and 1 patient was withdrawn for other reason(s) before the baseline visit.
730029|NCT01791894|We will recruit from medical clinic and other physicians who treat metastatic BCC|
730030|NCT01791803||
730031|NCT01791725||
730032|NCT01791517|A total of 269 Subjects were enrolled into this study. Of the enrolled 33 subjects did not meet the eligibility criteria. In Phase I 28 subjects were discontinued and 208 subjects completed Phase I. Of the 208 subjects that continued into Phase II 187 subjects completed the study and 21 subjects were discontinued from the from Phase II.|Subjects were first randomized to 1 of 3 lenses(Lens A: senofilcon A, Lens B: galyfilcon A, Lens C: etafilcon A), then within each lens subjects were randomized to 1 of 12 unique solution sequences, totaling in 36 sequences. Due to such a large number of sequences for reporting purposes, subject disposition is reported by solution and period.
730033|NCT01791491|16 participants were enrolled and 9 were treated. Reasons for non-treatment: 1 withdrew consent and 6 no longer met study criteria.|
730034|NCT01791465|Six HIV-infected participants recruited from the Vanderbilt Comprehensive Care Clinic between April 17, 2013 and May 6, 2016.|No consented participants were excluded prior to group assignment
730035|NCT01791413|Mar.2012-Feb.2013 University Hospital|Assessed for eligibility n=60 Excluded n=20 (15=not compatible with inclusion criteria 5=denied to participate)
730036|NCT01791244||A total of 93 subjects were randomized in the study out of which 46 were randomized to MinSupport Plus (MSP) and 47 to Technical support.
730037|NCT01791205|A total of 304 participants were enrolled in the study conducted from May 2013 to October 2014 at 29 centers in Italy.|
730038|NCT01791153|The study consists of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2).|"Of the 363 participants screened, a total of 251 participants were randomized into the study. One participant who was randomized to the Tocilizumab q2w + 26 weeks prednisone taper group withdrew on the same day of randomization and did not receive any study treatment. This participant was not included in any of the study analyses."
730039|NCT01791127||
730040|NCT01790932|Participants enrolled between June 2012 and September 2014.|
730041|NCT01790828||
730042|NCT01790750|Patients recruited in the NICU.|
730045|NCT01790633|"Volunteers were recruited from an innercity clinic for persons without healthcare coverage (Médecins du Monde, Paris, France). From February 25, 2013 to June 21, 2013, individuals seeking care at the center were asked to participate."|554 participants were initially screened for eligibility. 150 did not meet inclusion criteria, 16 had a medical condition requiring immediate referral to a specialist, and 61 declined to participate. A total of 327 were randomized.
730046|NCT01790594|Five sites in the United States recruited and enrolled 46 participants into this trial.|
730047|NCT01790581||
730048|NCT01790568||12 patients were enrolled in the initial NCI funded portion of the Vorinostat trial (NCT1789255). 26 were enrolled to the expansion of that trial (NCT01790568). 1 pt removed prior to transplant so 25 were evaluable. All patients were treated identically. Although 26 patients were enrolled to this portion of the trial, ALL 37 are analyzed together.
730049|NCT01790516||
730050|NCT01790503|A total of 65 participants (22 in Phase 1b; 43 in Phase 2) who met all inclusion criteria and no exclusion criteria were enrolled and treated in the study at 10 clinic sites in the United States.|This study included Phase 1b dose escalation where 5 cohorts were planned to be enrolled, each with approximately 7 participants (3+3 design) and Phase 2 where 37 participants were planned to be enrolled with the 7 participants treated at the RP2D level determined in the Phase 1b dose escalation phase yielding approximately 44 participants.
730051|NCT01790490|Participants were recruited using advertisements and were seen at NYSPI.|Participants were excluded if they could not comply with study procedures or if they were found to be ineligible.
730052|NCT01790438||
730053|NCT01790295|Recruitment began in February 2013, with first enrollment in November 2013.|
730054|NCT01790243||
730055|NCT01790178||
730056|NCT01790126||
730057|NCT01790048||
730058|NCT01789970|A total of 845 patients with moderate to severe chronic low back pain were screened at 78 centers in the U.S.|Of the 625 patients enrolled, 2 patients withdrew consent before taking any study drug. Of 623 patients who were enrolled and received study drug, 371 patients achieved a successful dose of hydrocodone extended-release (ER) tablets and were randomly assigned to receive hydrocodone ER or placebo during the double-blind treatment period
730059|NCT01789905||
730060|NCT01789814|24 subjects were enrolled to complete this study. The enrollment process took place in the adult cardiac catheterization laboratory at this hosptial. The inform consent process took place at the subject arrival time for the date procedure.|The randomized arm assignment was done by numbered envelopes. Once it was confirmed the subject was going to have a coronary intervention, the correspondent envelope was opened to assign the study arm drug.
730061|NCT01789775||
730062|NCT01789606||
730063|NCT01789567||
730064|NCT01789476||
730065|NCT01789255||
730066|NCT01789203||
730067|NCT01789138||519 participants (259 intervention + 260 control arm) randomized. Written informed consent forms of 2 not available (filed). Post-randomization study site control revealed 5 participants not having met the inclusion criterion 'receive or start (on recruitment date) ART'. Data of 512 participants (254 intervention + 258 control arm) analysed.
730068|NCT01789047||
730069|NCT01788943|10/01/2012-03/28/2014 recruitment at the Center for Interdisciplinary Research on Nicotine Addiction at the University of Pennsylvania|
730070|NCT01788631|Between July 2013 and November 2016, 4,940 hospital admissions were screened to enroll 100 study subjects. Patients were recruited at the time of sickle cell vaso-occlusive crises in outpatient clinics, emergency departments, and inpatient units.|Prior to study arm randomization and assignment, patients were screened using the following testing methods: Confirmation of sickle cell genotype, complete blood count with differential, chemistry, coagulation testing (Including PTT, and INR), and pregnancy testing for female participants.
730071|NCT01788566||
730072|NCT01788475||
730073|NCT01788423|The trial commenced November 2, 2012, and data collection ended August 31, 2016. Participants were recruited primarily by ads posted in the local newspapers and around the community. All testing of this volunteer sample took place in a university research clinic at Indiana University, Bloomington.|Of the 323 participants enrolled for assessment of eligibility, 135 were excluded because they did not meet inclusion criteria and 25 declined to participate, leaving 163 to be randomly allocated to one of the three intervention groups.
730074|NCT01788358|The study was conducted at 70 study centers between 14 February 2013 (first subject first visit) and 1 May 2014 (last subject last visit).|Of 753 subjects screened, 245 subjects were not enrolled, due to screen failure for 215 subjects, consent withdrawal by 23 subjects, protocol violation by 5 subjects, 1 subject was lost to follow-up and recruitment stopped for 1 subject. Remaining 508 subjects were enrolled and received at least 1 treatment with study drug.
730075|NCT01788228||
730076|NCT01788215|13 women were recruited. 3 did not meet inclusion/esclusion criteria.|
730077|NCT01788163|Males or females that had Stage IIIB or Stage IV adenocarcinoma of the lung and who were systemic treatment naive or patients with recurrent disease who have previously received adjuvant chemotherapy were enrolled 27 February 2013 and 25 July 2014. The study was carried out in Asiapac countries and Russia.|A total of 3500 patients were initially enrolled, of which 118 patients were enrolled but were excluded from the study upon failure to satisfy all eligibility criteria. These patients were not included in any analysis data sets.
730078|NCT01788046|This study was conducted at 97 centers in the US, Canada, Europe, Israel, the Russian Federation, and Australia. The first participant was enrolled on 12 March 2013, and the last participant 07 October 2013.|Eligible participants were randomized 1:1 to etelcalcetide or placebo. Randomization was stratified by screening parathyroid hormone (PTH) (< 600 pg/mL, 600 to ≤ 1000 pg/mL, and > 1000 pg/mL), prior cinacalcet use and region (North America or non-North America).
730079|NCT01787916||
730080|NCT01787838|All patients seen in the presurgical testing center who were eligible were offered the pneumococcal vaccine.|
730081|NCT01787825|Subjects recruited from population of patients prescribed capsule endoscopy for OGIB|
730082|NCT01787799|A total of 100 subjects were enrolled at 12 centers in Australia, New Zealand, Singapore and Japan between March 25, 2013 and October 15, 2013.|
748572|NCT00727402||
748573|NCT00727337||
730086|NCT01787552|A total of 50 subjects were enrolled in the study, of which 23 subjects were enrolled in Phase Ib part of dose-escalation phase and 27 subjects were enrolled in Phase Ib dose-expansion phase and Phase II Stage 1.|A total of 50 subjects were enrolled in the study, of which 23 subjects were enrolled in Phase Ib part of dose-escalation phase and 27 subjects were enrolled in Phase Ib dose-expansion phase and Phase II Stage 1.
730087|NCT01787461||
730088|NCT01787383||In the clinical study protocol 200 subjects were planned to be enrolled and 199 subjects were actually enrolled and randomised.
730089|NCT01787331||
730090|NCT01787292|Community-dwelling individuals were recruited for participation using approved flyer and advertising materials. All participants gave voluntary written consent prior to participation. After consenting, participants were randomly assigned to one of two 12-week exercise interventions involving a followed by cross-over to the other intervention.|
730091|NCT01787279|A total of 59 participants were enrolled in this study conducted from 13 January 2006 to 25 May 2009 at 9 centers in Kingdom of Morocco.|
730092|NCT01787240||
730093|NCT01787188||
730094|NCT01787175|Recruitment 12/2010 to 3/2011 at the Salt Lake City VA and University of Utah health care systems. Simulations took place at either of these locations.|
730095|NCT01787097|First participant was enrolled January 2013. 4 participants withdrew before randomisation.|
730096|NCT01787032|The primary objective of this trial was to investigate the relative bioavailability of BI 113608 as a single treatment (BI; Treatment A; Reference (R)) and in combination with Ketoconazole (K) (BI + K; Treatment B; Test1(T1)) or Voriconazole (V) (BI + V; Treatment C; Test2 (T2)).|
730097|NCT01787006||
730098|NCT01786993|The study enrolled 506 subjects at 49 investigational centers located in the U.S. A patient was considered enrolled upon signing informed consent. The first subject was enrolled on April 25, 2013. The study was double-blinded (the study subjects and the authorized personnel conducting the NYHA Class and Patient Global assessments were blinded).|455 out of 469 subjects with an attempted implant (97% success rate) received Quadripolar BiV pacing between implant and 3 months. At 3 months, responder status was assessed per Clincial Composite Score and 1:1 randomziation was stratified by responder status. 381 patients were randomized to either BiV (n = 180) or MPP (n = 201) at 3 months.
730099|NCT01786967||
730100|NCT01786954||
730101|NCT01786902||
730102|NCT01786876||
730103|NCT01786707||
730104|NCT01786668||In total 208 participants were randomized to double-blind treatment; 52 to each treatment group (tofacitinib 2 milligrams [mg] twice daily [BID], tofacitinib 5 mg BID, tofacitinib 10 mg BID, and placebo BID). One participant was randomized to the placebo group but did not receive study drug, as such only 207 participants received study treatment.
730105|NCT01786629||
730106|NCT01786603||
730107|NCT01786564||Of 120 participants enrolled in the study, 56 were eligible, continued in the study and provided some data.
730108|NCT01786551||
730109|NCT01786343|Recruitment Period: February 2013 - April 2018|74 participants were enrolled in the study, all participants completed the study.
730110|NCT01786330||There were 66 women assessed for eligibility. Of those women, six were excluded from the trial before being assigned to groups. Of the six women excluded: three presented to the hospital in labor prior to the scheduled cesarean, two reported for treatment for chronic pain, and one woman wanted the intervention regardless of randomization.
730111|NCT01786252||
730112|NCT01786239||
730113|NCT01786187|Participants were recruited from 3 university teaching hospitals in Michigan.This study incorporated a 2-arm randomized controlled trial design. Participants were persons who were undergoing surgery for non-small cell lung cancer and randomly assigned to 1 of 2 groups following successful completion of informed consent and baseline assessments.|Patients could become ineligible prior to starting the study postsurgery after discharge from the hospital to home at baseline data collection. For example, 3 patients decided not to have surgery and underwent chemotherapy instead and 2 patients became ineligible before hospital discharge because they no longer had a television to participate.
730114|NCT01786174||
730115|NCT01786161||
730116|NCT01786148|Participants were enrolled in the trial starting in June 2014 and randomized either to Educational music mobile app or to the Live Network mobile phone app|
730117|NCT01786109|All participants were recruited from a database of patients with irritable bowel syndrome (IBS) who reside within 120 miles of Rochester, Minnesota|
730118|NCT01785875|"This single-arm study was conducted at 205 centers in the US, Canada, Europe, Israel, Russian Federation and Australia. Participants were enrolled from 31 July 2013 to 9 June 2014.
~Participants who rolled over into another single-arm extension study 20130213 (NCT02102204) are reported as discontinuing the study due to protocol specified criteria."|This extension study enrolled participants from 1 of 3 parent studies: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970). In Studies 20120229 and 20120230, patients received either placebo or etelcalcetide 3 times a week (TIW) for up to 26 weeks; In Study 20120359, patients received 5 mg etelcalcetide TIW for 4 weeks.
730119|NCT01785849|This study was conducted at 111 centers in the US, Canada, Europe, Israel, Russian Federation, and Australia. The first participant was enrolled on 12 March 2013 and the last participant enrolled on 08 November 2013.|Eligible participants were randomized in a 1:1 ratio to etelcalcetide or placebo. Randomization was stratified by mean screening parathyroid hormone (PTH) (< 600 pg/mL, 600 to ≤ 1000 pg/mL, and > 1000 pg/mL), prior cinacalcet use and region (North America or non-North America).
730120|NCT01785680||
730121|NCT01785628|Date of recruitment period: 05-Aug-2010 to 08-Jun-2012 Type of location: Hospital, Medical China Universities, Neurology clinic.|The diagnosis of PD-D was based on the criteria proposed by 2007 movement disorders PD-D task force. 30 patients were enrolled.
730122|NCT01785615|Approximately 250 women volunteers were screened and 140 were selected to go on to the first phase of the trial. After a 6-week period of a run in diet phase, 24 did not return to start randomization. Out of 116 women, 6 failed to meet MBS criteria by one ATP III element.|
730123|NCT01785602||
730633|NCT01751230|Potential participants will be recruited via Institutional Review Board (IRB) approved posters and flyers displayed in the WIC office and advertisements posted on the PBRC website (http://www.pbrc.edu/clinicaltrials).|
730124|NCT01785524|6,852 patients in Duke Cardiology and Vascular Surgery Clinics were screened, 392 potential study candidates were identified, and 18 subjects were enrolled from March 2013 through January 2014. Of the 18 subjects, 11 were randomized and 7 completed all study testing.|
730125|NCT01785472||
730126|NCT01785459||
730127|NCT01785186||
730128|NCT01785160||
730129|NCT01785134||
730130|NCT01785095||
730131|NCT01785069||
730132|NCT01784991|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
730133|NCT01784965||1 person qualified and enrolled in study but dropped out before being randomized to either group. Therefore is not counted in placebo or liraglutide group.
730134|NCT01784926|Altogether 175 patients were assessed for eligibility, 104 patients were enrolled.|
730135|NCT01784848||
730136|NCT01784796|We had powered the study for a total of 110 participants (55 in each group). To account for attrition, we planned on recruiting a total of 138 participants (69 in each group).We enrolled 132 participants and 126 of these completed baseline data.|
730137|NCT01784770||
730138|NCT01784666||
730139|NCT01784614||This was a double-blind, randomized, placebo-controlled, 4-period cross-over study. The first 3 of which were used for polysomnography (PSG) measurements, and the fourth period was used to determine plasma concentrations of LY2624803 to estimate pharmacokinetic (PK) parameters.
730140|NCT01784588|Subject enrollment began on August 1, 2013 and was completed on December 23, 2014.|
730141|NCT01784419|72 patients were screened for eligibility.|All study participants are combined and reported here in one group because the data are reported this way in the only accessible data (in the publication). The PI has left the institution and the sequence specific data cannot be confirmed and are not available to be reported.
730142|NCT01784211|"Part A is 2- arm parallel open label.
~Part B is a crossover study with 2 treatment arms (LY2605541 & Glargine), each treatment arm consists of 2 sequences.
~Sequence 1: participants received treatment on days 16,17,18,19 & 20 with exercise on day 17.
~Sequence 2: participants received treatment on days 16,17,18,19, & 20 with exercise on day 20."|
730143|NCT01784055||
730144|NCT01784029|Patients were recruited aged 13-20 years from the Adolescent Medicine and Pediatric Endocrinology practices at Children's Hospital at Montefiore.|Of the 305 adolescents screened, only 203 met the inclusion criteria of being vitamin D deficient. Of the 203 adolescents identified with vitamin D deficiency, 20 were unable to be further contacted and randomized.
730145|NCT01783990||
730146|NCT01783938||177 enrolled, 140 randomized (70 to each arm). Reasons for non-randomization=1 adverse event, 1 withdrew consent, 32 no longer met study criteria, 3 for other non-specified reasons. 138 treated (68 nivo-ipi, 70 ipi-nivo). Reasons for non-treatment=1 adverse event unrelated to study drugs, 1 no longer met study criteria. Two cohorts of participants
730147|NCT01783912||
730148|NCT01783886|The study was conducted at centers in China, Hong Kong, South Korea, and Russian Federation between 18 February 2013 (first participant first visit) and 09 March 2015 (last participant last visit) (data cut-off date).|Overall 539 participants were screened, of them 381 participants were randomized, and 378 participants were allocated to treatment.
730149|NCT01783860|All 100 patients were selected from the eye clinic of Rasoule-Akram hospital during the study period. The patients were recruited sequentially.|Patients were excluded if they had: age< 12 years,history of ocular or lacrimal surgery,previous usage of contact lenses,history of ocular allergy or systemic diseases with ocular involvement, history of usage of topical or systemic antibiotic in the last month, pregnant or lactating mothers, liver failure and history of sensitivity to Cyclines.
730150|NCT01783847||
730151|NCT01783821|Subjects were enrolled from September 2013 to June 2015.|
730152|NCT01783743|Community randomized trial was conducted in 36 communities during MDA .Community served as unit of randomization & enrolled villages were randomly allocated on 1:1 basis to either intervention (n=18) or usual care (n=18) arms.Total MDA eligible population in control arm was 13509 individuals and in the intervention arm was 13964 individuals.|Community Treatment Assistants(CTAs) in intervention arm received an additional half-day training and TT screening card in addition to training received by CTAs in usual care arm. All MDA participants 15 years and older were screened for TT.Senior grader re-screened all TT cases identified by CTAs along with a selected random sample in both arms.
730153|NCT01783730||Participants who received adalimumab treatment
730154|NCT01783678|Participants were enrolled at a total of 39 study sites in Australia and Europe. The first participant was screened on 18 January 2013. The last study visit occurred on 10 July 2014.|346 participants were screened.
730155|NCT01783639||
730156|NCT01783574||
730157|NCT01783561||
730158|NCT01783548||A total of 770 subjects were screened. The 547 participants were randomly assigned to either BDP nasal aerosol (80 mcg/day) or placebo nasal aerosol in a 2:1 ratio.
730159|NCT01783522||
730160|NCT01783496||
730161|NCT01783483|Subjects were considered eligible for enrollment if they were undergoing an open heart surgery (e.g. CABG and/or valve surgery) with a full median sternotomy and met the inclusion/exclusion criteria. Patients were randomized at the time of sternal closure to receive either rigid sternal fixation (using sternal plates) or standard wire cerclage.|
730162|NCT01783470||There were 15 participants who were enrolled. Three of them did not have cold-induced detectable brown fat, so they did not continue to the randomization. The remaining 12 participants had cold-induced brown fat, so they were randomized.
730163|NCT01783418|In the experimental condition, over 9 months of recruitment, 481 youth were screened for participation in this project. Of these, 418 were excluded. Of the 63 remaining, only 13 agreed to participate, gave their consent, and provided a complete dataset.|Over 9 months of recruitment, 481 youth were screened for participation in this project. Of these, 418 (86.9%) were excluded because they lived further than 1 hour from the intervention site, had no history of cancer, had died or were not reachable by telephone. Recruitment for the control group was completed shortly after.
730164|NCT01783236||
730165|NCT01783080||
730166|NCT01783054||
730167|NCT01783015|In this 24 week, multicenter, randomized, double-blind, placebo-controlled (Period 1), 2 period study, a total of 20 participants were screened, out of which 16 participants were randomized. Due to delayed enrollment and an insufficient number of participants, recruitment was terminated.|Eleven participants were randomly assigned to etanercept [ETN] and 5 participants to placebo in the blinded treatment period. A total of 11 participants (9 ETN treated and 2 placebo treated) completed the blinded treatment period and entered the open label treatment with ETN. One of the 2 placebo treated participants entered the Escape Arm.
730168|NCT01782963||
730169|NCT01782898||
730170|NCT01782885|"Patients diagnosed with degenerative osteoarthritis were recruited from May 2013 to November 2015 in the Service of Orthopedics and Traumatology at the University Hospital Dr. José Eleuterio González of the Autonomous University of Nuevo León in Monterrey, México."|Only patients meeting inclusion criteria were assigned to a group (radiographic grade I and II osteoarthritis, mainly). Importantly, patients with previous surgical interventions, with concomitant diseases or with Hb values of <11 g/dL and platelet values of <150,000/µL were excluded prior to group assignment.
730171|NCT01782872||
730172|NCT01782859||
730173|NCT01782833||
730174|NCT01782742|Recruitment was conducted in the United States at one site. The first participant was enrolled in April 2013.|49 participants were screened, 29 were screen failures, 20 participants were randomized to treatment. 1 was withdrawn after Week 4 treatment. Inclusion and exclusion criteria was the strict basis for eligibility.
730175|NCT01782690||
730176|NCT01782664|A total of 68 participants with chronic plaque psoriasis were enrolled. The study was conducted at 13 centers in 2 countries: 10 in Germany and 3 in United Kingdom from 12 March 2013 to 24 March 2014.|A total of 68 participants were enrolled for this study. Of these, 1 participant was not dosed any study medication because the participant was taking prohibited concomitant medications.
730177|NCT01782495||This study included a 35-day screening period.
730178|NCT01782482|Participants were recruited from 30 study centers, located in the United States.|Of the 574 enrolled, 13 participants did not meet all inclusion/exclusion criteria and were exited as screen failures. This reporting group includes all enrolled and randomized participants (561).
730179|NCT01782469||
730180|NCT01782378|"VA Boston Healthcare System, Jamaica Plain Campus, Boston, MA Recruitment January 9, 2015 (date of first enrolled participant) - March 2018
~San Francisco VA Medical Center, San Francisco, CA Second site Recruitment started December 2016"|Both Sites Pre-Screened by Telephone or In-Office = 197; Enrolled, after Pre-Screening (Signed informed consent form (ICF/HIPAA) = 96; Screened, after Enrollment (Neuropsychological/Screening Tests administered) = 96 *must meet inclusion criteria to be randomized; Randomized, after Screening (Assignment to Group) = 63
730181|NCT01782326||
730182|NCT01782313|The study opened for accrual on February 25, 2013 with an accrual goal of up to 58 patients. The study was designed to enroll 19 patients initially and and continue to enroll up to 58 patients if 5 or more of the first 19 are progression free at 4 months. The study was closed permanently on February 4, 2015 with 58 patients enrolled.|
730183|NCT01782222|This study was planned to be conducted globally with 480 subjects (160 subjects per treatment group for the Full Analysis Set). Approx. 600 subjects were planned for enrollment in order to obtain 504 subjects for randomization. Subjects were randomized in a 1:1:1 ratio to either Rotigotine low dose, Rotigotine high dose or Placebo.|"The Participant Flow refers to the Randomized Set (RS). The RS included all subjects who were randomized.
~The outcome of the Interim Analysis was to stop the study, i.e. no more subjects were enrolled into the study and all included subjects completed the study as planned."
730184|NCT01782209||
730185|NCT01782131|After a screening phase of up to 7 days, 585 participants were enrolled/randomized, but only 575 began treatment (288 in the posaconazole [POS] group and 287 in the voriconazole [VOR] group).|
730186|NCT01781975|Recruitment Period: March 2013 to May 2016 at 9 clinical sites (8 US, 1 Australia)|
730187|NCT01781962||
730188|NCT01781832||
730189|NCT01781806||Of the 328 participants who enrolled in the study, 27 screen failed for various reasons and were not assigned to a cohort.
730190|NCT01781637||
730191|NCT01781611|All patients were recruited from the Oklahoma Medical Research Foundation clinic after a full informed consent process.|There were no pre-assignment restrictions or procedures.
730192|NCT01781572|Upon study entry, all patients were required to provide either an archival tumor biopsy with the corresponding pathology report or a newly obtained tumor biopsy. Both parts of the study were limited to patients aged 18 or older with metastatic or locally advanced NRAS-mutant melanoma.|"Screening details:
~Screening assessments were performed within 14 days prior to the first dose of ribociclib and binimetinib except for the pretreatment tumor biopsy, which was performed within 28 days before dosing. A total of 23 patients were screened but not enrolled."
730193|NCT01781481||
730194|NCT01781468||
730195|NCT01781429||
730196|NCT01781403|Participants were enrolled from 14 May 2013 through 8 May 2014|
730197|NCT01781299||
730198|NCT01781286||
730199|NCT01781234||
730200|NCT01781208|Pediatric patients aged 18 and younger were scheduled for a liver biopsy at a large pediatric hospital between 2012 and 2014. A total of 62 patients were recruited and enrolled. Patients and their parents gave consent/assent for the study.|
730201|NCT01781169|Subjects were recruited at a medical clinic (Health Service Center of Shuiku Community, Shenzhen, China) in May, 2011.|After enrollment, baseline information of the volunteers including vitamin D nutritional status, health records, etc. were evaluated. Including and excluding criteria were used to select the subjects who were suitable for the intervention trial.
730202|NCT01781078|363 patients were consented and enrolled in this study. 11 patients were withdrawn pre-implantation. 352 patients underwent the implantation procedure and 348 patients were successfully implanted. 1 patient died prior to randomization.|
730203|NCT01781026||
730204|NCT01780987||
730205|NCT01780974||Med exclusions included Omega-3 fatty acid supplement intake < 4 months prior to enrollment; Lipoic acid supplementation < 1 month prior to enrollment; stable dosage for 4 months prior to enrollment of antihypertensive medication and (if prescribed) lipid lowering medication. Other exclusions included labs and test scores out of range.
730209|NCT01780831|"Cohort 1 participants were from 2 sites in Brazil, 1 site in South Africa and 7 sites in the USA. Enrollment period was January 2014 - December 2015.
~Cohort 2 participants were from 3 sites in Brazil, 2 sites in South Africa,1 site in Thailand, and 4 sites in the USA. Enrollment period was September 2015 - November 2017."|
730210|NCT01780662||This is a Phase I /II study. Phase I determined the Maximum Tolerated Dose (MTD) between the first 2 treatment arms; 16 patients enrolled and 9 patients completed therapy. The study was closed and reopened to accrual for Phase II which enrolled an additional 30 patients. Overall, 46 patients were enrolled but only 29 patients completed therapy.
730211|NCT01780584|Subjects recruitment was done from Pediatric Cardiac Intensive Care Unit at the National Cardiovascular Center Harapan Kita, Jakarta, Indonesia between April, 2010 and September, 2010.|There were 47 individuals screened for participation, and consent to participate was obtained from 46 (98%). One subjects from whom did not participate because of surgical postponement. A total of 45 subjects were randomized to 3 groups of 15.
730212|NCT01780545||
730213|NCT01780506|Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 26 December 2012. The last study visit occurred on 06 September 2017.|1105 participants were screened.
730214|NCT01780454||
730215|NCT01780389||
730216|NCT01780350||
730217|NCT01780337||
730218|NCT01780324|Dates of recruitment: 1/30/2013 through 4/27/2014 Location of recruitment: Emergency Department|"All patients consented were randomized.
~186 patients were screened 106 were excluded (41 did not meet inclusion criteria, 52 families declined participation, 13 medical team declined participation, 1 family refused catheterization 80 patients enrolled and randomized"
730219|NCT01779869||
730220|NCT01779700||
730221|NCT01779648|The recruitment started in March, 2012 and ended in January, 2013. A total 57 participants were recruited and tested for enrollment after admission to the hospital.|Two of them were excluded prior to group assignment because of the detection of a lung cancer and a deep vein thrombosis, respectively.
730222|NCT01779440||
730223|NCT01779375||
730224|NCT01779219||
730225|NCT01779167||
730226|NCT01779141||
730227|NCT01779024||
730228|NCT01778985||
730229|NCT01778855||
730230|NCT01778751|Recruitment occurred December 2013-May 2014 at the Durham VA Medical Center outpatient primary care clinics.|
730231|NCT01778634|Recruitment period July 1, 2013- August 31, 2016 at 7 U.S. hospital Neonatal Intensive Care Units (NICUs).|
730232|NCT01778556||
730233|NCT01778530||
730234|NCT01778426|The first subject enrolled in the study on January 13, 2012. The last subject was enrolled on December 19, 2013 and the last visit of the last subject was on January 11, 2016. A total of 414 patients were assessed for eligibility, across 28 sites in France, of which, 402 subjects were included in the final analysis.|Not applicable; this study was non-randomized in which no treatment group was assigned.
730235|NCT01778296|From February of 2008 to March of 2011,12 patients with soft tissue defects in the middle phalanx or the proximal interphalangeal joint were included in the study.The type of location is medical clinic. These patients were treated with the neurocutaneous island flap.|No wash out, run-in or transition happened in our study.
730236|NCT01778179||
730237|NCT01778127|This protocol enrolled 105 participants at St. Jude Children's Research Hospital from 9/2013 through 4/2014. Of the 105, 5 were determined to be ineligible after baseline screening (4 too active; 1 did not meet IQ criteria), and 2 withdrew prior to randomization but after baseline testing. The remaining 98 were randomized.|98 participants were randomized 1:1:1 stratified by gender into 3 groups. Randomization was implemented using software based on Zelen's methodology. The principal investigator and study staff were blind to group assignment.
730238|NCT01778062||
730239|NCT01778049|Subjects randomised to 16 week(wk) open-label (OL) treatment with either empagliflozin (empa) 25 or empa 10 treatment, thereafter subjects entered to 1 wk open label placebo (Plc) add-on period in order to complete further eligibility evaluations before being randomised into 1 of the 24 wk double-blind treatment groups.|This was a randomised, double-blind, multi-national, parallel group trial. In this trial the treatment effects of linagliptin (lina) 5 compared with Plc were analysed as add-on to either empa 25 or empa 10. All trial treatments were administered in addition to metformin background treatment.
730240|NCT01778023|The trial was conducted at 10 sites in Korea.|
730241|NCT01778010||
730242|NCT01777997|Recruited at 19 Clinical Research Sites (CRSs) in the United States between April 25, 2013 and December 22, 2014.|
730243|NCT01777945||46 participants were enrolled in the study and included in safety assessments. 45 participants were included in other assessments.
730244|NCT01777932|A total of 220 participants were enrolled across 34 centers in Hungary from 20 December 2007 to 08 March 2011.|
730245|NCT01777854||
730246|NCT01777776|"Recruitment to CLEE011X2105 began on 10-July-2013. The study concluded on 13-April-2015. Participant Flow data is comprised of the Full Analysis Set (FAS), which is all patients who received at least one dose of LGX818 or LEE011.
~Not completed subjects represents subjects that stopped treatment early, due to the corresponding reason."|In response to developments in the treatment of melanoma, the sponsor reviewed the data from the ongoing study and decided to halt further enrollment of patients in the Phase Ib part of the study. Consequently, the Phase II part of the study was not performed. Early termination of the study was not due to any safety concerns.
730247|NCT01777763||
730248|NCT01777620||
730249|NCT01777581||
730250|NCT01777568||
730251|NCT01777542||"Assessments findings during the Screening Visit that could result in ineligibility after informed consent include:
~Scoliosis curve > 40º by x-ray
~Bone age > 11 years by x-ray
~Cardiomegaly by echocardiogram
~Tanner Stage II breast development by physical exam
~Prolonged QTc by ECG"
730252|NCT01777490||Patient's and their informal caregiver are randomized as a dyad to a single arm assignment, either HI-FIVES or Control.
730253|NCT01777438||
730254|NCT01777425||
730255|NCT01777412||
738900|NCT01235962|The study was planned to include 1500 subjects. A total of 1538 subjects were enrolled and analyzed.|
730256|NCT01777334||Participants (par.) who met the eligibility criteria at Screening (Visit 1) completed a 7- to 10-day Run-in Period and entered a 24-week Treatment Period. 1191 par. signed the informed consent form and were assigned subject numbers, 1053 par. were screened and 905 par. were randomized and received at least one dose of study medication.
730257|NCT01777321||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
730258|NCT01777308||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
730259|NCT01777295||
730260|NCT01777282|A total of 360 participants with type 2 diabetes mellitus (T2DM) were planned and 374 participants were enrolled and analyzed in the Safety Population; the Safety Population and Intent-to-Treat Population were identical in this study.|Eligible participants entered a 2-week Screening Period; a 52-week Treatment Period and an 8-week Follow-up (FU) Period.
730261|NCT01777269|This is a European double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function in men with moderate/severe Benign Prostatic Hyperplasia (BPH)|Eligible participants (par.) entered a 4-week Placebo Run-in Phase, and were randomised in 1:1 ratio to receive DUODART (fixed dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg) and placebo one capsule daily for 52 weeks. Follow-up was performed 6 months after the last dose of study medication
730262|NCT01777217||
730263|NCT01777191||
730264|NCT01777152||
730265|NCT01777139|Participants with partial-onset seizures (POS) who successfully completed the maintenance phase of study RTG114855 (NCT01648101) were recruited in this open-label extension (OLE) study.|All the participants received at least 1 dose of retigabine (RTG) immediate release (IR). Screening was performed on the day of final visit of the parent study. A total of 30 participants, 12 from placebo and 18 from RTG group who completed the treatment and transition phases of the parent study were included in this OLE study.
730266|NCT01777126|All adult patients admitted undergoing an elective and unproblematic radical cystectomystarting in 01/02/2009 were consecutively assigned to the control group until the predefined sample size was attained. After completion of the control group, all newly admitted patients were, again consecutively, assigned to the experimental group.|If a transfer was needed, the patient was excluded. Other exclusion criteria were preoperative contra-indications for EN and discharge to a rehabilitation center.
730267|NCT01776723||
730268|NCT01776645||
730269|NCT01776632||
730270|NCT01776554|Subjects were enrolled at 10 centers in United States and 2 centers in Thailand.|All enrolled subjects were included in the trial.
730271|NCT01776541|Subjects were enrolled at 4 centers in the US, 3 centers in Australia and 1 center in Thailand.|All enrolled subjects were included in the trial.
730272|NCT01776424|Study was conducted at 602 centers with randomized participants in 33 countries between 28 Feb 2013 (first patient first visit) and 18 Jul 2017 (last patient last visit for antithrombotic part).|Overall, 29872 participants were screened, of which 2477 participants were screen failures. A total of 27395 participants were randomized to one of the study treatment arms.
730273|NCT01776268||
730274|NCT01776008||
730275|NCT01775995||
730276|NCT01775930|This was a single arm, single-center, non-randomized study of carfilzomib in participants with refractory ccRCC. Participants were accrued over a period of 195 days.|
730277|NCT01775904||
730278|NCT01775865||A total of 59 participants were consented/enrolled. A total of 13 were excluded or lost to follow up after consent (n=8 did not meet inclusion criteria after screening; n=1 lost to follow up; n=1 time committment; n=1 moved out of state; n=2 other).
730279|NCT01775852||
730280|NCT01775800|There were 300 dialysis patients screened. 51 were eligible to participate and 16 were randomized.|
730281|NCT01775787||
730282|NCT01775774|This dose-escalation Phase 1 clinical trial with 3 cohorts with 3 subjects/cohort was performed in 7 centers in USA between July 2013 to January 2014.|
730283|NCT01775735||28 subjects were consented in the study. 13 failed screening and 15 were randomized. Statistically relevant conclusions cannot be made from this small sample size.
730284|NCT01775722||
730285|NCT01775670||
730286|NCT01775553||
730287|NCT01775501||
730288|NCT01775371|Recruitment occurred from April 30, 2013 through February 25, 2016 in the Emergency Departments of three medical centers.|
730289|NCT01775189|Recreational opioid users who had experience with intranasal administration of opiates and were not dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, were recruited in this study.|After successful naloxone challenge test, all participants underwent training sessions involving complete pharmacodynamics test battery before the drug discrimination phase, to ensure that participants fully understood how to perform the tests, were comfortable, and attained a stable level of performance on the various performance-based measures.
730290|NCT01775137|The study was conducted at 22 centers in 9 countries.|Of 96 participants who completed the core study (CTBM100C2401), NCT01519661; 45 participants were enrolled in the extension study.
730291|NCT01775124||A total of 334 patients were randomized in this study. One patient was mis-randomized to ranibizumab 0.5 monthly group and another patient was discontinued due to AE. Neither patient received any treatment
730292|NCT01774981||
730293|NCT01774968||
730294|NCT01774929||
730295|NCT01774903||
730296|NCT01774851||
730297|NCT01774799||Participants are analyzed as dyads; proxies and patients.There are 402 dyads, for a total of 804 participants.
730298|NCT01774786||A total of 780 participants were enrolled in the study.
730299|NCT01774760|11 were recruited, 10 started and completed|1 patient withdrawn because of a negative FDG PET scan
730300|NCT01774721||
730301|NCT01774604|All patients who presented to Dartmouth-Hitchcock Medical Center for Endoscopic Retrograde Cholangiopancreatography (ERCP) for any reason between March 2013 and December 2014|
730302|NCT01774591||
730303|NCT01774370|This study is a prospective, non-interventional, open-label, multi-centre study.|All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be entered to trial treatment if any one of the specific entry criteria was violated.
730304|NCT01774344|The study was conducted between 14 May 2013 (first subject first visit), 29 February 2016 (primary completion date) and 05-July-2019 (Last Patient Last Visit =End of study).|Overall, 843 subjects were screened, of them 270 subjects were screening failures. 573 subjects were randomized and assigned to treatment; of them 6 subjects never received treatment. 436 Entered survival Follow-up and 4 End of survival follow-up data not available.
730305|NCT01774305|recruitment period : Sep.2012. ~ Jan. 2013 types of location : medical clinic.|there was no specific pre-assignment details.
730306|NCT01774253||
730307|NCT01774149||
730308|NCT01774110||
730309|NCT01774097|Enrollment took place at seven Network centers and their associated satellite facilities between 6/13/2013 and 12/8/2015. The main centers are located in Texas, Florida (2 locations), Minnesota, Kentucky, Indiana, and California. Study brochures, patient informational DVDs, and clinicaltrials.gov were among the tools used for recruitment.|
730310|NCT01774084|Recruitments between December 2011 and November 2012, at Södersjukhuset, Karlolinska Institutet, Stockholm.|No significant events took part in current studies.
730311|NCT01774045||
730312|NCT01773993||
730313|NCT01773967||
730314|NCT01773954||
730315|NCT01773889|This study was open to accrual on 7/29/2009 and closed to accrual on 6/27/2011. Subjects were seen at The Cancer Therapy and Research Center @ The University of Texas Health Science Center San Antonio.|"Intercurrent illness that prevents further administration of treatment
~Unacceptable adverse event(s)
~Patient withdraws from study
~General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator."
730316|NCT01773473||This study consisted of a 26-week treatment period (12-week, weekly-intensive, dose-adjustment period and 14-week maintenance period).
730317|NCT01773421|Participants took part in the study at 6 investigative sites in the Netherlands and United Kingdom from 30 June 2011 to 12 November 2017.|In Part A, a total of 18 participants were enrolled, out of which 15 participants were randomized and treated. In Part B, a total of 27 participants were enrolled, out of which 26 participants were treated.
730318|NCT01773291|Patients with severe traumatic brain injury (Glasgow Coma Scale, GCS ≤ 8) admitted to neurosurgical intensive care unit (NSICU) were enrolled and randomly divided into three groups sequentially.|Exclusion criteria: dilated pupils without light reflex, unstable vital signs, serious complication during therapeutic course, serious multiple injuries, withdrawal by subject, physician decision, without informed consent.
730319|NCT01773226|Single-centre study in the Netherlands. FPI April 2013.|All patients treated with APS who had at least 1 post-injection assessment of clinical outcomes were to be included in the clinical outcomes population, which was used for the clinical outcomes summaries and listings
730320|NCT01773187||
730321|NCT01773135||
730322|NCT01773122||The protocol was amended mid-study to exclude patients <16 years.
730323|NCT01773109||
730324|NCT01773070|This follow-up study was open to participants from AbbVie studies M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).|
730325|NCT01772823|This research was conducted at 12 clinical sites. Accrual was open between July 2012 and September 2013.|
730326|NCT01772758||
730327|NCT01772719|7 subjects were enrolled into this trial by the investigator from medical clinic|
730328|NCT01772693||
730329|NCT01772654|Subjects were recruited at Mayo Clinic in Rochester, Minnesota.|73 subjects signed informed consent, but 56 subjects were excluded from analysis, as they turned out to have generalized epilepsy or non-localizable focal epilepsy. Patients who turned out not to have epilepsy, but non-epileptic behavioral spells served as control subjects. Two subjects were definitely left temporal onset and therefore analyzed.
730330|NCT01772576|167 patients were enrolled in the study. Patients were considered enrolled when the consent form was signed regardless whether they received the RELIANCE 4FRONT lead or not. Recruitment started on 22 November 2012. Last patient was enrolled 9 March 2014.|No wash out or run-in period was planned for the study. 3 patients did not receive the study lead: lead not available at site, wrong lead chosen and patient needed MRI (magnet resonance imaging) compatible lead, while the RELIANCE 4FRONT lead was not labeled MRI compatible.
730331|NCT01772550|"Subjects were recruited from those referred to the Johns Hopkins Outpatient Center for contrast enhanced computed tomography, or CECT. Subjects were recruited in January and February of 2013.
~The Overall Study table summarizes the number of subjects that Started and Completed in each Reporting Group, including the type of CECT procedure."|Subjects whose veins were determined to be unable to accommodate an 18 GA IV catheter, but that could accommodate a 20 GA IV catheter, were not randomized but were assigned to receive the 20 GA BD Nexiva™ Diffusics™ IV catheter (non-randomized cohort).
730332|NCT01772537||
730333|NCT01772472||1486 patients were randomized in 268 centers across 28 countries.
730334|NCT01772368|A total of 105 subjects with asthma were screened for this study. Of the 105 subjects screened, 82 subjects at 10 investigational sites in the US met entry criteria and were considered to be eligible to enter the run-in period.|Ten subjects failed randomization.
730335|NCT01772316||A total of 47 participants were enrolled in the trial and received treatment. All participants enrolled were included in the safety analysis. Of the 47 participants, 13 participants were not included in the statistical analysis for outcome measures because they did not meet eligibility criteria.
730336|NCT01772160||Out of 395 subjects originally enrolled in this study, 1 subject was excluded due to protocol violation, hence only 394 were included in the Total Cohort.
730568|NCT01755416|20 participants were screened. However only 18 participants were enrolled into the study. Of these 15 participants completed both study visits. Patients were recruited from diabetes clinics, via fliers, and online postings on clinical trial sites.|
730337|NCT01772147|A total of 872 participants who met the eligibility criteria at Screening (Visit 1) started a 28-day Run-in Period, in which they received open-label fluticasone propionate and salmeterol (FSC) 250/50 micrograms (µg), prior to being randomized to a 12-week randomized Treatment Period.|A total of 608 participants were randomized in the study; however, only 606 of these 608 participants were included in the Intent-to-Treat Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the Treatment Period.
730338|NCT01772134|A total of 682 participants who met the eligibility criteria at Screening (Visit 1) started a 28-day Run-in Period, in which they received open-label fluticasone propionate and salmeterol (FSC) 250/50 micrograms (µg), prior to being randomized to a 12-week randomized Treatment Period.|A total of 617 participants were randomized; however, only 614 of the 617 randomized participants received at least one dose of randomized study medication in the Treatment Period.
730339|NCT01771991||
730340|NCT01771965|"The trial implemented the intervention at the VA's National Crisis Line during a period of dynamic change at the Crisis Line including turnover of top leadership and major changes in procedures and personnel.
~Our bottom line recruitment numbers were low."|
730341|NCT01771952||
730342|NCT01771913|patients who have contour irregularities after any method of breast reconstruction. recruited from jan/2012 to august/2014.|
730343|NCT01771809|The study was conducted at 101 centers in 21 countries between 18 Mar 2013 (first participant first visit) and 13 Dec 2017 (last participant last visit).|A total of 331 participants were randomized and 330 participants received treatment in the study. One participant discontinued due to adverse event prior to receiving treatment.
730344|NCT01771731||
730345|NCT01771666||
730346|NCT01771627||
730347|NCT01771250||Insulin treatments were transitioned by gradual tapering/titration as required at the start of each period and the end of Period 2 based on the participants individual randomization and pre-study therapy.
730348|NCT01771172||
730349|NCT01770912|Subjects were recruited from 2013-2018 from facial pain referrals to the Oral and Maxillofacial Surgery Clinic.|
730350|NCT01770860|One additional subject was enrolled but withdrew before randomization.|
730351|NCT01770743|Participants were enrolled from 16 January 2013 to 14 November 2013 at 4 medical centers in the United States.|All 168 enrolled participants who met eligibility criteria were dosed.
730352|NCT01770691||
730353|NCT01770652||
730354|NCT01770509||
730355|NCT01770483|Data was collected from diabetic patients coming to diabetes management center Services Hospital Lahore. Recruitment started on july 2011 and last patient was recruited in March 2012.|"Initially 153 patients were recruited but only 66 patients were enrolled in the trial based on our inclusion criteria. Following patients were excluded:
~33 because of HCV genotype other than 3
~18 because of normal ALT
~9 with undetectable HCV PCR
~2 because of thyroid dysfunction
~25 were lost to follow up"
730356|NCT01770431|Patients were recruited from 39 hospitals in China between December 7, 2011 and December 31, 2014. 1044 patients met eligibility criteria and were randomly assigned at a 2:1 ratio: 696 in Huaier group and 348 patients in the blank control group.|
730357|NCT01770392||
730358|NCT01770379|Patients received AIN457 75 mg, AIN457 150 mg or placebo as subcutaneous (s.c.) loading dose once weekly at baseline (BSL), Weeks 1, 2, 3 and 4, followed by monthly maintenance starting at Week 4.|At Wk 16, patients were classified as responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1).
730359|NCT01770366||
730360|NCT01770353|Six study centres in the United States recruited subjects into this Phase 1, 2-phase, non-comparative, open-label study. Each phase consisted of 4 stages: screening, ferumoxytol (FMX) treatment, irinotecan liposome injection (MM-398) treatment and follow-up (30 days after last dose).|Subjects with solid tumours were recruited to the Pilot phase. Subjects with locally advanced or metastatic breast cancer (BC) were recruited to the Expansion phase which consisted of 3 cohorts dependent on BC tumour sub-types and the presence of active brain metastases. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.
730361|NCT01770314|Participants were recruited via an online advertisement as well as through posters|
730362|NCT01770145||
730363|NCT01769612|168 subjects were enrolled in the regions of Sidi Bouzid and Gafsa, Tunisia|
730364|NCT01769586||
730365|NCT01769573||
730366|NCT01769508||
730367|NCT01769469|The research was conducted at 11 clinical sites. Accrual was open between November 2012 and December 2013.|
730368|NCT01769456|This research was conducted at 6 clinical sites. Accrual was open between 7/16/2013 and 9/30/2014.|
730369|NCT01769443|"The study planned to enroll 80 participants; however, the decision to terminate the study was made due to the very slow rate of participant accrual and the inability to meet the recruitment goal within the funding period. Only 2 participants were enrolled at one site before study recruitment status changed to Active, not recruiting."|
730370|NCT01769404||As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.
730371|NCT01769391||A completer is defined as having a complete radiographic assessment at baseline and at least one complete post-baseline radiographic assessment of CR, PR , SD or PD.
730372|NCT01769378||
730373|NCT01769365|We surveyed patients who visited the gastroenterological clinic of Kaohsiung Medical University Hospital (KMUH), Kaohsiung Veteran General Hospital (KVGH). A total of 307 H. pylori-infected patients were randomly assigned to triple (n=103 ) or sequential (n = 102) or concomitant (n = 102) therapies.|
730374|NCT01769352||
730375|NCT01769339||
730376|NCT01769326||
730377|NCT01769274||
730378|NCT01769248||
730379|NCT01769222||
730380|NCT01769209||
730381|NCT01769196|Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 31 January 2013. The last study visit occurred on 23 February 2016.|1250 participants were screened.
748574|NCT00727311||
730386|NCT01768637|Participants were recruited from December 10, 2012 to January 31, 2014 from outpatient clinics at Parkland hospital, Dallas Veterans Affairs hospital and University of Texas Southwestern Medical Center, Dallas, TX, USA.|From 1,545 participants screened from outpatient clinics, 196 eligible patients were approached for enrollment, 128 refused and 48 signed consent.
730387|NCT01768572|The study was conducted at 78 centers in 19 countries. A total of 389 participants were screened between 25 March 2013 and 02 April 2014, 187 of whom were screen failures. Screen failures were mainly due to failure to meet inclusion and exclusion criteria.|Randomization of participants were stratified by region and screening value of absolute neutrophil count. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in 1:1:2 (sarilumab 150 mg q2w: sarilumab 200 mg q2w: tocilizumab q4w). 202 participants were randomized.
730388|NCT01768559|The study was conducted at 199 centers in 18 countries. A total of 2159 participants were screened between January 08, 2013 and April 10, 2014.|Participants underwent a 12-week run-in period with switch from other basal insulins to insulin glargine. A total of 1265 participants were screen failures/run-in failures; the most frequent reason for run-in failure was that glycosylated hemoglobin (HbA1c) criteria were not met at the end of run-in phase. 894 participants were randomized.
730389|NCT01768520||
730390|NCT01768325||85 participants were enrolled in this study but only 78 were randomized.
730391|NCT01768286|Participants were enrolled at a total of 64 study sites in the United States. The first participant was screened on 03 January 2013. The last participant observation occurred on 20 February 2014.|551 participants were screened.
730392|NCT01768117||
730393|NCT01768013|First subject first visit: 09-Jul-2012 Last subject last visit: 30-Oct-2012|Prior to treatment at Visit 1, a washout period was completed if the subject was treated or had recently been treated with anti-psoriatic treatments or other relevant medication, as defined by the exclusion criteria. The washout period could last up to a maximum of 4 weeks.
730394|NCT01768000|Recruited between March 2013 and February 2014 in Ontario, Canada.|
730395|NCT01767987||
730396|NCT01767935||
730397|NCT01767909||
730398|NCT01767792||
730399|NCT01767701|Patients 18-55 years of age with RRMS, as per McDonald Criteria 2010, EDSS up to 6.0, relapse within the past 12 months or at least one active Gd enhanced lesion on brain MRI within the 3 months prior to consent. All participants were recruited at the Clinical Research Centre of the Royal London Hospital and drawn from greater London.|31 subjects screened. 8 had no evidence of Gd enhancing lesions in their baseline MRI and were screen failed. Of the 23 participants who were recruited into the study 3 were withdrawn prior to starting the treatment phase; one at the request of the participant and the remaining two due to MS relapse.
730400|NCT01767688|Adult (18 to 80 years of age) males and females participated in the study. Eight participants with moderate hepatic impairment, and eight healthy control participants (matched according to age, weight, gender, and creatinine clearance [CLCr] or estimated glomerular filtration rate [eGFR]), were enrolled.|
730401|NCT01767636||
730402|NCT01767597|From 29 February 2012 to 5 July 2012, volunteers were recruited from five study centers in the Paris metropolitan region, which actively participate in HBV screening, vaccination, and care - two sexually transmitted disease clinics, one primary healthcare center, one general screening center, and one travel clinic.|2061 participants were initially screened for eligibility. Of them, 625 did not meet inclusion criteria and 436 declined to participate. In total, 1000 participants were randomized.
730403|NCT01767519|Participant Flow is for Treatment cycle 1, which is the double-blind portion of the study and includes the primary timepoint.|
730404|NCT01767506||The trial was conducted at the community level and not at the participant level.Therefore, we are presenting the data only at the community level.
730405|NCT01767467||Out of the 568 subjects enrolled, only 562 subjects received vaccination as per protocol and hence started the study.
730406|NCT01767415||
730407|NCT01767376||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. Out of the 692 subjects enrolled in this study, one subject was eliminated due to not receiving vaccination, hence only 691 subject started the study.
730408|NCT01767285|60 participants signed consent. 1 participant was a screen failure. 59 participants were randomized.|
730409|NCT01767194||
730410|NCT01767155||
730411|NCT01767142|Subjects with clearly visible fat in the treatment area (outer thigh) were recruited from two clinical research sites.|Screening of all subjects was completed to ensure each subject met all inclusion criteria and none of the exclusion criteria. A brief medical history and exam was performed at the screening visit. All female subjects of child bearing potential were given a pregnancy test.
730412|NCT01767116||
730413|NCT01767103||
730414|NCT01767064||
730415|NCT01766921|1393 subjects were enrolled at 12 centers in the US, 5 centers in Australia, 2 centers in New Zealand and 4 centers in Thailand.|All enrolled subjects were included in the trial.
730416|NCT01766817||"Total 325 participants were enrolled,out of which 143 participants were randomized and treated. Reasons for not being treated were:Screening HRCT or Pulmonary function tests did not meet study criteria and Other reasons"
730417|NCT01766778||There was 117 patients randomized and received either Vildagliptin 50mg QD or 50 mg BID.
730418|NCT01766713||
730419|NCT01766466|The purpose of this study was to study the pharmacodynamic characteristics of transition from IV cangrelor to oral ticagrelor, and ticagrelor to cangrelor in patients with coronary artery disease. This was a single-center study, conducted in Jan-Feb 2013.|Patients with coronary artery disease who were taking aspirin, but not P2Y12 inhibition were enrolled.
730420|NCT01766440||
730421|NCT01766401||
730422|NCT01766336||
730423|NCT01766310||
730424|NCT01766219||
730425|NCT01766206|Healthy subjects from 2 months to 55 years of age were enrolled in 46 centres in South Korea.|Out of the 3,948 subjects enrolled, only 3,939 subjects were exposed to vaccination as 1 subject did not receive a study vaccination and 8 subjects did not provide post vaccination safety data. Among 3939 subjects, 15 subjects are in the ≥ 56 age category (outside the range defined as per the protocol).
730427|NCT01766076|30 participants were recruited from the Infectious Diseases Institute research cohort (single site) and followed up for 12 weeks, 4 weeks wash out period and 12 weeks after cross over of treatment assignment|Participants were selected if they had sustained viral suppression for 7 years and CD4 increases below 300 cells/ul
730428|NCT01766050|Study initiated January 2013 and completed April 2013. Participants (healthy volunteers) checked into a clinical pharmacology unit (CPU) on Day -1 for screening.|45 were enrolled and 22 dosed with study drug. Reasons for not dosing: 5 withdrew consent, 1 lost to follow up, 1 poor/non-compliance, 15 no longer met study criteria, and 1 other.
730429|NCT01766037|First Subject Screened Oct 30, 2012; First Subject Enrolled Nov 13, 2012; Last Subject Enrolled June 13, 2014|
730430|NCT01766024||
730431|NCT01765972|A total of 39 subjects were enrolled in this study. Of those enrolled subjects 15 subjects did not meet the eligibility criteria. The remaining 24 subjects were successfully dispensed a study lens and completed the study.|
730432|NCT01765920||
730433|NCT01765803||
730434|NCT01765764||
730435|NCT01765751||
730436|NCT01765673||Of the 13 enrolled, 1 did not pass cognitive testing and did not participate in the study
730437|NCT01765647||
730438|NCT01765582||
730439|NCT01765569||
730440|NCT01765543||A total of 27 participants were enrolled into the study.
730441|NCT01765530||
730442|NCT01765465||
730443|NCT01765426|Participants took part in the study at 2 investigative sites in the United States from 15 February 2013 (First participant signed Informed Consent Form) to 26 June 2014 (date of last participant's visit/contact).|Healthy Volunteers were enrolled equally in 1 of 4 treatment groups: Group 1 (2 doses), Group 2 (2 doses) Group 4 (3 doses) of Tetravalent Dengue Vaccine (TDV) using PharmaJet® Injector and Group 3 (2 doses) TDV using needle and syringe.
730444|NCT01765270||
730445|NCT01765192|Participants took part in the study at 12 investigative sites in Germany, Hungary, and South Africa from 15 February 2013 to 24 October 2013.|Participants with a historical diagnosis of severe asthma who were inadequately controlled while receiving a combination of at least medium dose inhaled corticosteroids and long-acting beta agonists maintenance therapy were enrolled in 1 of 2 treatment sequences, 500 µg roflumilast plus 10 mg montelukast once daily (QD) or 10 mg montelukast QD.
730446|NCT01765179||
730447|NCT01765153||
730448|NCT01764997|The study was conducted at 228 sites in 31 countries. A total of 1949 participants were screened between 09 May 2013 and 07 Aug 2014 of which 1173 participants were screen failures and a total of 776 participants entered in the adalimumab run-in phase of the study.|Of 776 participants, 365 completed adalimumab run-in phase, of whom 43 non-responders randomized (1:1:1) in double-blind fashion to receive sarilumab 150 mg, sarilumab 200 mg or etanercept 50 mg; 322 responders entered in open label sub-study. 373 participants did not proceed into randomized phase or sub-study and 38 discontinued from run-in phase.
730449|NCT01764945||
730450|NCT01764919||
730451|NCT01764854||
730452|NCT01764841|Study was conducted at 124 study centers in 14 countries (Argentina, Australia, Denmark, France, Germany, Israel, Italy, Japan, Latvia, New Zealand, Slovakia, Spain, UK and US) between 02 May 2013 (first subject first visit) and 09 March 2016 (last subject last visit).|Overall 902 participants were screened, of them 486 were screen failures, and 416 were randomized, out of which 414 participants were assigned to the treatment. One participant from Ciprofloxacin 14 Days on/off group and one participant from Placebo 28 Days on/off group did not receive the study treatment after initial screening.
730453|NCT01764685||
730454|NCT01764659||
730455|NCT01764633|Participants were enrolled at 1242 clinical centers in 49 countries in the regions of Europe (62.9%), North America (16.6%), Asia Pacific (13.9%), and Latin America (6.6%) from 08 February 2013 to 05 June 2015.|Eligible participants were randomized in a 1:1 ratio to receive either subcutaneous (SC) evolocumab or placebo. Randomization was stratified by the final screening low-density lipoprotein cholesterol (LDL-C) level (< 85 mg/dL vs ≥ 85 mg/dL) and by geographical region.
730456|NCT01764607||
730457|NCT01764464||53 subjects signed consent and were enrolled in the study. 22 subjects were ineligible after enrollment for the following: did not meet inclusion/exclusion criteria (n=12), withdrew consent during screening period (n=5), non-responder to gabapentinoid during washout period (n=5). A total of 32 subjects were randomized, 25 completed.
730458|NCT01764386||
730459|NCT01764256||
730460|NCT01764022||"In BCD-022 group 2 patients were exluded from any analysis due to:
~Death prior to the first drug administration
~Informed consent withdrawal prior to the first drug administration"
730461|NCT01763996|Participants took part in the study at one investigative site in the United States from 29 May 2013 (first participant signed the formed consent form) to 14 April 2015.|Participants with a diagnosis of chronic stable angina were enrolled in one of 2 sequence cross-over arms: (1) febuxostat 80 mg for 6 weeks then placebo for 6 weeks, or (2) placebo for 6 weeks then febuxostat 80 mg for 6 weeks.
730462|NCT01763970||
730463|NCT01763931||
730464|NCT01763918|Men and women 18 to 80 years old with a diagnosis of heterozygous familial hypercholesterolemia (HeFH) on stable doses of an approved statin with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL were eligible for this study. The first participant enrolled on 07 February 2013 and the last participant enrolled 03 September 2013.|Participants received subcutaneous placebo corresponding to the once monthly dose volume during a 6-week screening period. Those who completed the screening period and met final eligibility criteria were randomized 1:1:2:2 into 4 treatment groups. Randomization was stratified by LDL-C level (< 160 mg/dL vs ≥ 160 mg/dL) and ezetimibe use.
730465|NCT01763905|"Men and women ≥ 18 to ≤ 80 years of age who have tried at least 2 statins and were unable to tolerate any dose or increase in statin dose due to muscle-related side effects were eligible for this study.
~The first participant was enrolled on 24 January 2013 and the last participant enrolled on 29 August 2013."|Participants received subcutaneous placebo corresponding to the once monthly dose volume during a 6-week screening period. Those who completed the screening period and met final eligibility criteria were randomized 1:1:2:2 into 4 treatment groups. Randomization was stratified by low-density lipoprotein cholesterol (LDL-C) level and statin use.
730466|NCT01763866|"Adults aged 18 to 80 years with screening low-density lipoprotein cholesterol (LDL-C) ≥ 150 mg/dL (no statin at screening), ≥ 100 mg/dL (non-intensive statin at screening), or ≥ 80 mg/dL (intensive statin at screening) and fasting triglycerides ≤ 400 mg/dL.
~First patient enrolled on 15 January 2013; Last patient enrolled on 10 July 2013."|"2067 patients were first randomized to 1 of the 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg); 1899 were then randomized to blinded investigational product.
~Randomization into the statin dose cohorts was stratified by entry statin therapy and by use of certain concomitant medications."
730467|NCT01763827|Men and women ≥ 18 to ≤ 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL and fasting triglycerides ≤ 400 mg/dL with a 10-year Framingham Risk Score of 10% or less were eligible for this study. The first participant was enrolled on 21 January 2013 and the last participant was enrolled 29 July 2013.|Participants received subcutaneous placebo corresponding to the once monthly dose volume during a 6 week screening period. Participants who completed the screening period and met final eligibility criteria were randomized 1:1:1:1:2:2 into 6 treatment groups. Randomization was stratified by LDL-C concentration (< 130 mg/dL or ≥ 30 mg/dL).
730468|NCT01763788||Completers included participants who died from any cause and participants who were alive and on study (but off treatment) at study conclusion.
730469|NCT01763645||134 of 138 patients received at least one dose of the study drug/comparator. 4 patients discontinued the study without receiving a single dose of the study drug/comparator. 88 patients received all 6 therapy cycles and completed the main study period in accordance with the Protocol. 50 subjects withdrew from the study.
730470|NCT01763606||
730471|NCT01763567||
730472|NCT01763346|Recruited from Kaiser Permanente Southern California|Five participants randomized to metformin and six participants randomized to gastric banding refused to initiate treatment
730473|NCT01763333|Subjects were recruited from the volunteers' pool of the Human Pharmacology Centre of Boehringer Ingelheim (BI) Pharma GmbH & Co. KG, Ingelheim, Germany.Only male subjects were included because no data on reproductive toxicology was available.|68 subjects were randomised for single rising dose (SRD) part &12 subjects for bioavailability(BA) part of study.
730474|NCT01763203|The dates of the recruitment period are from February 13, 2014 through August 31, 2017.|Not applicable; all enrolled participants were assigned to an arm.
730475|NCT01763047||This study enrolled a total of 298 subjects. Subjects were stratified as either Hyperopes or Myopes, which was determined by their sphere power. Of the enrolled subjects 22 did not meet the eligibility criteria and 276 subjects were randomized a study lens. Of the randomized subjects 29 were discontinued and 247 subjects completed the study.
730476|NCT01762982|Participants were recruited at the clinical site.|Of 37 participants screened, 1 did not meet the study criteria. Remaining 36 were randomized to the study. Two negative controls, one positive control and one test product were used simultaneously and inserted into the patch (Finn chamber patch test device) as it was a 4-way split plot design study.
730477|NCT01762943|Out of 3,341 completed screening forms, 406 women appeared initially eligible. 54 were responsive, interested in participating, and eligible to enroll based on pre-screening (unmedicated, without current psychiatric illness or chronic health conditions).|Of the 54 women who were recruited to participate, 18 did not meet our eligibility criteria during the extensive safety screening phase because of medical conditions found upon exam, use of medications, family history of reproductive cancer, history of pregnancy-related medical condition, and lack of compliance with the screening protocol.
730478|NCT01762904||
730479|NCT01762800||A total of 570 participants were screened, 428 participants entered into the run-in period, 406 participants were randomized into the study (incorrectly 407 on protocol summary due to miss operation at study site that cannot be corrected), and 405 participant received study medication and comprised the modified Intent to Treat (mITT) Population.
730480|NCT01762761|This study includes three stages: 8-week double-blind stage (Stage 1), 24-week open-label stage (Stage 2) and prolonged open-label stage (Stage 3) with voluntary participation until eltrombopag became commercially available in China. Final Results for this study are presented in this report.|Participants diagnosed with primary immune thrombocytopenia (ITP) for at least 12 months prior to randomization, platelet count of <30×10^9/Liter (L) within 48 hours (hrs) prior to Day 1; no response or relapsed after splenectomy or if not splenectomised and either not responded to prior therapies or relapsed to prior therapy were enrolled.
730481|NCT01762722|Recruitment 09/2009 - 06/2010 at Duke University Medical Center.|Healthy volunteers recruited with specific exclusion of anemia & hemoglobinopathy.
730482|NCT01762631|Individuals were recruited through advertisements and targeted emails directed to residents of the Greater Baton Rouge area.|
730483|NCT01762501|Enrollment was performed at hospital and clinic|957 patients was enrolled in this study. In run-in period, 239 patients were withdrawn.
730484|NCT01762345||148 subjects entered the 2-week baseline phase and 65 dropped/failed before treatment
730485|NCT01762059||
730486|NCT01761747||
730487|NCT01761643||
730488|NCT01761565||
730489|NCT01761292||"This is a single arm study and not a parallel group study. Patient enrollment occurred sequentially, until 20 patients were treated (part 1). For the entire design please refer to detailed study description. Only demographics are reported by 3 Givinostat dose levels, while AEs and outcomes results are reported for the whole Givinostat population."
730490|NCT01761279|Patients attending for colonoscopy at Portsmouth Hospitals NHS Trust throught the Bowel Cancer Screening programme were recruited from May 2010-May 2011.|Cohort study - single cohort. Patients found to have inflammatory bowel disease or a polyposis syndrome were excluded
730491|NCT01761266|Participants took part in the study at 154 investigative sites in Australia, Belgium, Canada, China, France, Germany, HongKong, Israel, Italy, Japan,SouthKorea, Malaysia,Philippines,Poland,Russia,Singapore,Spain,Taiwan,Thailand,United Kingdom and the United States from 1 March 2013 to 13 November 2016 (date of data cutoff for the primary analysis).|A total of 1,492 participants were screened, 954 participants were enrolled and randomized, out of which 951 participants were treated in the study.
730492|NCT01761175||
730493|NCT01761162||
730494|NCT01761084||
730495|NCT01761019||
730496|NCT01760993||Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
730497|NCT01760954|"Participants who completed the 6-month Treatment Period in the pivotal Study M12-665 (NCT01620528) were eligible to enter this extension study.
~A total of 506 participants were enrolled at 131 sites in the United States, Puerto Rico, and Canada. Two enrolled participants did not receive study drug and are not included in the tables reported below."|The study consisted of a 6-month Treatment Period and a Post-treatment Follow-up (PTFU) of up to 12 months. Participants who received elagolix in the pivotal study continued to receive the same dose for a further 6 months; participants on placebo in the pivotal study were randomized 1:1 to either elagolix 150 mg once daily or 200 mg twice daily.
730498|NCT01760941||
730499|NCT01760889||Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
730500|NCT01760876|From Dec 20, 2012 to July 24, 2014, 106 patients enrolled for BioFreedom stent implantation and agreed to participate in the study at Queen Mary Hospital, Hong Kong.|100 patients should be enrolled and randomly assigned to 5 monthly groups (n = 20:20:20:20:20) but 6 patients could not complete all the 3 OCT assessments (0 to 9 months) for reasons stated below and therefore a total of 106 patients were enrolled with BioFreedom study stents implanted and agreed for the study.
730501|NCT01760785|Recruitment occurred between in December 2008 and was completed in May 2014. Participants were recruited from the local VA medical center and the surrounding area. Recruitment included television advertisements, bus banners, flyers distribution, hospital signage, and word of mouth. 637 participants were initially screened via telephone.|Screening was done in two phases: telephone and in-person. Telephone screening included questions about the severity of the traumatic brain injury (TBI), substance use history, mood lability, medical and psychiatric history, and availability of proxy reporter. The in-person phase included screening for exclusionary cognitive or physical impairment.
730502|NCT01760733|All patients 65 years and older who were accepted on the Norwegian kidney transplantation waiting list between January 1st 2013 and November 30th 2016 were invited to participate (n = 437). 289 were included, reasons for exclusion were reluctant to participate ( n = 21), not meeting inclusion criteria (n = 21) and not responding (n = 105).|
730503|NCT01760473||
730504|NCT01760447|"The study recruited participants in clinics/clinical offices in 28 countries.
~One participant who was randomized to the arm Sitagliptin/Metformin withdrew prior to treatment, then was re-randomized into the study. Only the second randomization is counted for Participant Flow and All-Cause Mortality, so this participant is not counted twice."|The Pre-Assignment Period included a one-week single-blind placebo run-in prior to randomization during which participants received metformin with sitagliptin/metformin placebo or metformin XR with sitagliptin/metformin XR placebo each day.
730505|NCT01760304||
730506|NCT01760239|Primary care providers (physicians, physician assistants,nurse practitioners) as of April 2014 were eligible. Providers received a letter inviting them to complete surveys (pre and post intervention). Completing surveys was considered implied consent. Patient consent was waived as no direct contact between patients and study team occurred.|31,579 patients 10-17 years of age with >=1 BP measurement were assessed for eligibility for the primary analysis. After excluding for non-incident hypertension, and restricting to patients with BPs at >=3 visits with BP >=95th percentile who meet case definitions for new onset hypertension, the analytic denominator equals 522.
730507|NCT01760187||
730508|NCT01759862||
730509|NCT01759602||
730510|NCT01759511|Participants were enrolled at 6 study sites in the United States. The first participant was screened on 18 October 2012. The last study visit occurred on 19 February 2016.|37 participants were screened.
730511|NCT01759446|44 recreational drug users with snorting experience were enrolled with 40 completing-Crossover designed|Each subject had to pass a blinded snorted drug discrimination phase to meet enrollment.
730512|NCT01759420||
730513|NCT01759407||
730514|NCT01759381||
730515|NCT01759368||
730516|NCT01759290|A total of 1800 subjects were enrolled at 87 outside US (OUS) study sites across 21 counties worldwide. The first patient registered on January 21, 2013. The patient registration was complete on Aug 30, 2014, and the last patient completed the 1-year clinical follow-up on Sep 09, 2015. The database has been closed on Oct 30, 2015.|A total of 81 subjects are discontinued from the study population (1800) due to death:17, withdrawal of consent:5, withdrawn by physician:2, loss to follow-up:53 and unknown reasons:4. A total of 28 subjects with MI/revascularization events or reached 1-year follow-up window were included in the clinical outcome analysis.
730517|NCT01759277||
730518|NCT01759264||
730519|NCT01759251||
730520|NCT01759160|The recruitment process started from Dec. 2012, ended in Jan.2013. Study location is The First Affiliated Hospital of Sun Yat-sen University.|enrolled participants were excluded when they were found allergic to drugs used during the study.
730521|NCT01758900||
730522|NCT01758731||
730523|NCT01758588||Patients were randomized to either the treatment arm or the control arm of the study with a 2:1 allocation ratio. 8 patients were enrolled. No patients crossed over from observation to treatment.
730524|NCT01758523||47 subjects not randomized: 23 excluded at in person screening visit; 24 subjects withdrew prior to randomization
730525|NCT01758432|Subject recruitment occurred at investigative site in the US between November 2012 through October 2013|Apixaban was administered orally at 5 mg twice daily for 6 days to steady-state in an open label fashion. Subjects were then randomized to receive study treatment (andexanet:placebo, 6:3) intravenously at different doses/dose regimens on Day 6, all bolus doses administered such that they ended at 3 hours after the last dose of apixaban.
730526|NCT01758289||
730527|NCT01757964||
730528|NCT01757847||
730529|NCT01757821||All subjects received all 3 interventions
730530|NCT01757717||
730531|NCT01757704|Patients who were scheduled at the Department of Cardiothoracic Surgery, anesteshia and intensive care at Skane University Hospital for elective open left sided heart surgery were eligible for inclusion. Recruitment started in september 2012 and ended in june 2013.|In this study a total of 4 participants did not complete due to intraoperative exclusion criteria only possible to detect after start of the surgical procedure (adherant lung, accidental pleural opening, TCD signal insufficient). Enrollment and randomization continued until 10 patients in each arm were included and satisfied protocol criteria.
730536|NCT01757535|Participants were randomized at 147 investigational sites within Europe: Italy, Germany, Spain, United Kingdom, France, Turkey, Austria, Poland, Portugal, Russian Federation, Belgium, Israel, Czech Republic, Ireland, Lithuania, Finland, the United States, Canada, Mexico, Australia, South Korea, Taiwan, and Brazil.|"Participants were randomized to oral azacitidine or placebo and stratified by:
~Age (at induction therapy)- 55-64 years versus (VS) ≥ 65 years
~Prior history of myelodysplatic syndromes or chronic myelomonocytic leukemia
~Cytogenetic risk (induction therapy): intermediate-risk VS poor-risk
~Given consolidation therapy after induction- Yes/No"
730537|NCT01757405|Enrollment was conduced at 16 clinical sites from the following countries: Japan, Taiwan, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine and the United States.|40 participants provided informed consent and were screened for study participation, of which there was 1 screen failure. 39 participants (in pre-assignment period) were randomized where 1 participant withdrew after randomization but prior to treatment, therefore 38 participants were treated with recombinant activated factor VII BI (rFVIIa).
730538|NCT01757301||Two participants were excluded from the study after enrollment. Both participants failed screening and were considered ineligible.
730539|NCT01757275|"Overall, 239 patients were enrolled from 19 centres in China. The first patient entered the study on 26 February 2013 and the last patient completed the study on 30 December 2014.
~Of the 239 patients enrolled into the study, 222 (92.9%) patients were randomised to treatment."|"17 patients were not assigned to treatment, 15 patients did not fulfil the eligibility criteria, 1 was due to patient decision, and 1 patient due to other (not enough experimental drug)."
730540|NCT01757197||
730541|NCT01757184|A total of 56 study centers located in 17 countries were initiated in this study. Participants were enrolled and treated at 41 centers in 15 countries, including 35 primary centers where participants initiated treatment and 6 qualified local medical centers where participants who were medically stable were transferred for long-term treatment.|To assess eligibility, participants were screened for a period of up to 6 weeks prior to enrollment in the study. A total of 86 participants were screened. Six of these participants underwent rescreening (of which 2 were eligible for the study). In total, 66 participants were eligible for the study and 20 participants were screen failures.
730542|NCT01757171||
730543|NCT01756976||
730544|NCT01756885||
730545|NCT01756846|Inclusion at 9 Dutch Emergency departments, recruitment period between 1-7-2013 and 31-8-2014.|Exclusion criteria were evident ST-segment elevation myocardial infarction, language barriers, recurrent presentation, or unable or unwilling to give informed consent.
730546|NCT01756586||
730547|NCT01756573||
730548|NCT01756560||
730549|NCT01756456|The study consisted of 2 periods: 8week PhaseI/controlled treatment period and 48/56-week FU period. In the Phase1 patients were randomized into 2 cohorts (of 9 pts each). In phase 2 pts were randomized in a 1:1:1 ratio (52 pts each group). Data refer to the 1st database lock when the last patient in Phase2 had completed 12 weeks of FU period.|The inclusion/exclusion criteria were designed to include individuals 18 years of age or older with Stage 2 (PED) or Stage 3 (corneal ulcer) NK involving only 1 eye and to exclude those with Stage 2 or 3 NK affecting both eyes, any active ocular infection or inflammation not related to NK, or any ocular disease or severe vision loss.
730550|NCT01756391||
730551|NCT01756352||
730552|NCT01756300|The study enrollment took approximately 11 months, began in December 2, 2012 and completed on November 4, 2013. A total of 68 subjects were consented and 35 started the renal denervation with the investigational ablation catheter.|After signing the inform of consent, subjects were evaluated on inclusion/exclusion criteria, anatomic eligibility, compliant with completing the subject diary. Thirty-three subjects failed and never underwent insertion of the study ablation catheter.
730553|NCT01756274||
730554|NCT01756235|A total of 462 participants were enrolled: 460 were in the main analysis set (MAS) population; 2 were excluded from MAS, as adalimumab treatment was not documented within this study.|
730555|NCT01756209||
730556|NCT01756157|This study was conducted at 24 sites (United States=20, Europe=4) between 04 February 2013 (first participant dosed) and 13 September 2013 (last participant contact). Of 52 screened participants, 47 were randomized and treated. Screen failure reasons were consent withdrawn by 1 participant and violation of eligibility criteria by 4 participants.|Due to emergence of, and unexpected incidence and titer of, non-neutralizing anti-rHuPH20 antibodies in some subjects after administration of CINRYZE+rHuPH20, sponsor decided to stop dosing subjects with rHuPH20 and thus close the study. However, the study was completed with collection of safety data as outlined in the protocol.
730557|NCT01756079||A total of 130 participants were screened. Sixty participants passed screening, but 2 of these participants were excluded before assignment because standard of care treatment was not received during the Lead-in Period.
730558|NCT01756053|Fifty three subjects were consented and screened for eligibility at an Intake Visit between April 2013 and December 2013 at the Center for Interdisciplinary Research on Nicotine Addiction (Philadelphia, PA).|Seventeen of the 53 subjects were randomized and received study medication. Of those NOT randomized, 30 were deemed ineligible and 6 withdrew from the study.
730559|NCT01755949||
730560|NCT01755858||
730561|NCT01755767|A total of 383 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment. One participant in the tivantinib 120 mg BID cohort was randomized but did not receive treatment.|Eligible participants were randomly assigned on a 2:1 basis to either tivantinib or placebo. Initially, the tivantinib dosage of 240 mg was selected on the basis of efficacy and tolerability established in Phase 1 and Phase 2 studies.
730562|NCT01755702|This was a multi-center study conducted at 7 centers.|66 participants were randomized. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes, for example participants experiencing 2 episodes would take the first 2 treatments, but would not get the 3rd treatment. Such participants would be considered as completer, not a withdrawal.
730563|NCT01755689||
730564|NCT01755637|Study was conducted at two clinical sites in China.|Out of 123 screened participants, 54 did not meet the study criteria; 12 withdrew consent and one was lost to follow -up. Only 56 participants were randomized.
730565|NCT01755598|Out of 3575 subjects enrolled in the study, 2 subjects did not get any vaccination and therefore were not included in any analysis.|
730566|NCT01755546||
730570|NCT01755169||A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.
730571|NCT01755156||
730572|NCT01755143||
730573|NCT01755091|Participants were recruited from physician referrals at two academic medical centers as well as from the community based upon print and radio advertising between January 2013 and May 2016. The first participant was enrolled in February 2013 and the last participant was enrolled in April 2016.|
730574|NCT01755026||
730575|NCT01754987||
730576|NCT01754922||
730577|NCT01754909|50 consented|"Verification of eligibility.
~Seven did not start study drug. Six of those because found ineligible after enrollment. One of those because of early termination of study."
730578|NCT01754766||
730579|NCT01754727|A total of 452 participants were enrolled: 450 were in the main analysis set (MAS) population; 2 were excluded from MAS, as adalimumab treatment was not documented within this study.|
730580|NCT01754714||
730581|NCT01754688|Recruitment was carried out at Massey Street Children's Hospital and the surrounding community in Lagos, Nigeria. Recruitment began in January 2013 and ended in March 2015.|
730582|NCT01754623|Participants were enrolled at Moffitt Cancer Center from March 2013 through December 2013.|
730583|NCT01754519||
730584|NCT01754493|Study participants were recruited through print and electronic advertisements (n=12). We also received referrals from community clinicians (n=3), a former patient (n=1) and a psychiatric help line (n=1). Recruitment took place from 1/19/07 to 5/20/14.|This study was a single-arm open trial, so all the participants were assigned to the open-label duloxetine treatment arm.
730585|NCT01754480||
730586|NCT01754467||Participants were only excluded if they did not meet the eligibility criteria or were no longer interested in participating.
730587|NCT01754402|Recruitment began in January 2013. Dose escalation ended in November, 2013. Expansion enrollment began in December, 2013 and ended in September 2016. Patients were recruited from the Bone Marrow Transplant Clinic and Hematologic Malignancies Clinic at Duke University Medical Center.|Nine patients were consented to the study for cohort 1, however, 3 were screen failures. Seven patients were consented to the study for cohort 2, however, 5 were screen failures. Forty patients were consented to the study for the expansion phase, however, 10 were screen failures.
730588|NCT01754389||"Excluded (n= 4)
~Not meeting inclusion criteria (n=3;active infection (2*), disease relapse (2*))
~Declined to participate (n=1; interacting medication per provider preference (1))"
730589|NCT01754376|Patients were recruited at Massachusetts General Hospital (Boston, MA) between February and November 2013|
730590|NCT01754259||The order of ranolazine and placebo exposure was randomly assigned in a 1:1 ratio by the Investigational Drug Service at BWH. During the 28-day treatment periods, ranolazine and matching placebo were administered as 500 mg by mouth twice daily for 1 week and increased to 1000 mg by mouth twice daily for 3 weeks, as tolerated.
730591|NCT01754207||
730592|NCT01754194|293 adults were enrolled from 17 Mentor (performed at least 50 procedures) and Mentee (performed less than 50 procedures) bariatric German referral centres. They were stratified for laparoscopic sleeve gastrectomies and Roux en Y gastric bypass (ideally 50:50). First participant enrolled April 2012 Last participant enrolled October 2013.|Use or preference of surgical procedure was at the discretion of the surgeon. For each patient, the study consisted of three phases: Screening/Baseline; Surgery; Post-operative observation for up to 12 months. Data were gathered per SoC (Standard of Care) at each of the three study phases.
730593|NCT01754129||Screened population: all participants who were screened for the study
730594|NCT01753999|Subjects were recruited between January 2013 and December 2016 at three World Trade Center Health Program Clinical Centers of Excellence (Rutgers University, Icahn School of Medicine at Mount Sinai, and New York University School of Medicine).|Subjects without OSA were excluded from the trial.
730595|NCT01753856||Tetracycline (TET) and demeclocycline (DEM) temporarily bind to new bone and are detected as different colors under ultraviolet light in bone biopsy samples. In this study, participants were administered DEM prior to randomization (baseline) and again with TET 22 days prior to bone biopsy obtained 3 months post first dose of study drug.
730596|NCT01753830||
730597|NCT01753739||
730598|NCT01753713||
730599|NCT01753570||
730600|NCT01753557||
730601|NCT01753518|Subjects were recruited from the Mayo Clinic Family Birth Center (labor and delivery) in Rochester, Minnesota. Subjects were recruited from December 2012 until the end of April 2014.|220 subjects were randomized to suture or absorbable subcuticular staples and 206 were included in the final analysis with 103 in each group. One subject crossed over from absorbable subcuticular staples to suture intraoperatively, because the attending surgeon was not comfortable with the staple closure device.
730602|NCT01753401|38 enrolled participants were randomized 2:1:2:1 into four treatment groups, to receive Acthar 0.5 mL daily: Placebo 0.5 mL daily: Acthar 1 mL every other day: Placebo 1 mL every other day, during the double-blind period, along with their stable dose of steroids.|All participants were to receive their stable steroid regimen in addition to the study drug throughout the double-blind period (Period 1). If they completed Period 1, they were invited to participate in an open label period (Period 2). Those who received Placebo went into Placebo/Acthar, and those who received Acthar went into Acthar/Acthar.
730603|NCT01753362||
730604|NCT01753336|This was an open label extension (OLE) study for study A-TL-52120-169 (Study 169). First subject enrolled: 14 March 2013; last subject completed: 13 October 2015. A-TL-52120-170 (Study 170) was conducted in 36 centres in the United States that had participated in Study 169 and enrolled adult subjects with cervical dystonia (CD).|Subjects who completed Study 169 and had no on-going Adverse Events (AEs) or whose Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score between Weeks 4 and 8 was reduced by ≤15% from baseline were invited to participate in this OLE study. 112 of the 134 subjects in Study 169 were enrolled into Study 170 (signed informed consent).
730634|NCT01751178|Participants were recruited at the clinical site.|A total of 775 subjects were screened and 324 subjects were randomised of whom 319 completed the study. The high screen failure rate was due mainly to subjects not having sufficient permanently gradable teeth.
730605|NCT01753323||The enrollment of P. vivax malaria patients (Cohort 1) began first. Then the falciparum cohort began enrollment after four vivax patients had completed their dosing. Cohort 3 was enrolled after the completion of an interim analysis of safety, tolerability and efficacy data of seven completed patients in the second cohort of Part 1.
730606|NCT01753310|First subject enrolled: 7 January 2013; last subject completed: 9 January 2015. 46 investigational sites in the United States of America were planned, 43 sites were initiated and 38 sites enrolled adult subjects with cervical dystonia (CD).|150 subjects were screened; 16 subjects failed screening. 134 subjects were enrolled (signed informed consent) and were randomised with a 2:1 ratio of Dysport®:placebo. Randomisation was also stratified for subjects who were Botulinum toxin type A (BoNT-A) treatment naive or non-naive at baseline.
730607|NCT01753297|The study was conducted in male subjects with high-risk prostate cancer who had undergone radical prostatectomy (RP) in 18 sites in China and Russia between Dec 2012 and Sep 2019. The study participation for each subject was at least 36 months. The end of study was when 61 biochemical relapse (BR) events were observed on the study global level.|Subjects had to have undergone RP no more than 8 weeks prior to randomisation, with post-RP prostate specific antigen (PSA) levels ≤0.2 nanograms/millilitre (ng/mL). The screening visit took place 6 weeks after RP (i.e. 2 weeks prior to randomisation). No other treatment for prostate cancer was permitted.
730608|NCT01753193|The study was conducted from 28 Mar 2013 to 18 Jul 2018.|A total of 218 participants were enrolled in this open-label extension (OLE) study.
730609|NCT01753115|Subjects were enrolled from 14 Dec 2012 to 04 Aug 2013 at 3 US sites.|
730610|NCT01753076||A total of 304 participants were randomized (151 to placebo; 153 to ozanezumab 15 milligrams [mg]/kilogram [kg]), and 303 participants (151 placebo; 152 ozanezumab 15 mg /kg ) received at least one dose of investigational product (one of the participants who did not receive any study drug was re-randomized to ozanezumab).
730611|NCT01752985||319 were enrolled, 110 completed screening, rest 209 discontinued: (Main reason:did not meet study criteria). Of 110 screened, 98 entered Placebo Lead-in period of which 89 completed period, rest 9 discontinued (2 due to Admin. reason, 3 no longer met study criteria, 2 AEs and 2 were lost to follow-up.)1 was randomized but declined treatment
730612|NCT01752933|A total of 68 patients were screened for enrollment in the study. Of these, 16 were screen failures. Reasons for screen failure included not meeting all eligibility criteria (14 patients) and withdrawal of consent (2 patients).|Of the 52 patients enrolled in the study, 2 did not receive any treatment. Reasons for not receiving treatment included death for one patient and no longer meeting eligibility criteria for the second patient.
730613|NCT01752907|This study was conducted at 48 centers in the United States. Patients with stage I to III breast cancer planning to receive standard neoadjuvant or adjuvant chemotherapy regimens with pegfilgrastim support for at least 4 cycles were included. The first participant enrolled on 17 January 2013 and the last participant enrolled on 04 September 2014.|Participants were randomized in a 1:1 ratio to receive 1 of 2 educational DVDs: general chemotherapy side effects education DVD (GE-DVD) or bone pain education DVD (BP-DVD). Participants remained on study for the first 4 chemotherapy cycles. End of study occurred 30 days after administration of pegfilgrastim in the fourth cycle of chemotherapy.
730614|NCT01752855||
730615|NCT01752842|Subjects were recruited from clinics, practices and laboratories within the Barnes-Jewish Hospital consortium, Volunteer for Health and Diabetes Research Connections recruitment programs at Washington University School of Medicine, and through local advertisements, posters, emails and flyers. Dates of recruitment were from May 2013 to October 2017.|Potential subjects were given the approved consent form to consider. If interested, they were scheduled for a screening visit in the Center for Applied Research Sciences. The consent form was signed before any testing took place. Blood and urine were collected and a cardiac stress test was performed to evaluate the subject for eligibility.
730616|NCT01752712||83 participants signed a consent form for the study. 4 of these subjects were deemed ineligible before starting any study procedures, and 17 participants were withdrawn from the study prior to randomization for various reasons. Therefore, 62 subjects were randomized to a study treatment group (31 CBSST+oxytocin, 31 CBSST+placebo).
730617|NCT01752634|The study population was comprised of subjects who had passed screening assessments, complied with eligibility criteria and had provided written consent|"At baseline, all eligible subjects were randomized via Interactive Response Technology (IRT) to one of the 4 treatment arms.
~At Week 16, Subjects on Placebo were rerandomized to receive secukinumab 150 mg s.c. or 300 mg s.c. from Week 16 (non-responder) or Week 24 (responder)."
730618|NCT01752426|Recruitment Period: December 2012 - June 2013|
730619|NCT01752400||
730620|NCT01752036||33 of the 35 enrolled participants received treatment.
730621|NCT01752023||
730622|NCT01751971||
730623|NCT01751906|The first Lead-In subject (Lead-In Group ) was registered on Dec 28, 2012. A total of 2008 patients (Primary Analysis Group) were randomized into Absorb BVS arm (n = 1322) and Xience arm (n = 686) at 193 study sites between 22 March 2013 & 3 April 2014 and the last 3 year follow-up visit was on August 28,2017.|"Of total 13,789 eligible population,11,781 patients were excluded due to,
~Not meeting general eligibility criteria only (n=567);
~Not meeting angiographic eligibility criteria only (n=10,690);
~Not meeting both 1 and 2 (n=64);
~Other reasons (n=460)."
730624|NCT01751867|This study was conducted across 12 centers in China.|
730625|NCT01751802||
730626|NCT01751724|Recruitment was conducted at the Holtz Children's Hospital newborn intensive care unit of Jackson Health System/University of Miami Medical Center from January 2013 to October 2015.|87 infants were enrolled. Of these, 1 died before randomization. 86 infants were randomized and assigned an intervention arm.
730627|NCT01751646|This research was conducted at 17 clinical sites, with accrual opening 10/2012. Due to budgetary constraints, accrual to protocol Version 1.0 was placed on hold 9/1/2013; follow-up visits for subjects on study continued while accrual was on hold. Version 2.0 opened to accrual on 2/2/2015. The study was closed to accrual on 6/3/1015.|
730628|NCT01751568|Accrual occurred between November 2014 and April 2019 in four (4) sites from South Africa.|
730629|NCT01751412||
730630|NCT01751399||
730631|NCT01751386||
730632|NCT01751308|Participants were enrolled at 12 centers between February 2013 and March 2015.|Phase I was a dose escalation part of Cabazitaxel to determine maximum tolerated dose (MTD). Phase 2 was efficacy and safety evaluation of Cabazitaxel at the MTD, determined in Phase 1.
730635|NCT01751165||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
730636|NCT01751139|In December 2017, GSK decided to deprioritize the development of the dengue purified inactivated vaccine (DPIV) candidate. This decision was made due to the significant scientific challenges of dengue vaccine development.|
730637|NCT01751113|A total of 53 Japanese participants with moderate or severe chronic obstructive pulmonary disease (COPD) entered the run-in period.|Participants, who met eligibility criteria, completed a 2-week Run-in Period prior to being randomized to 1 of 6 treatment sequences. The treatment phase was comprised of three 4 week treatment periods, each separated by a 2-week washout period.
730638|NCT01751087|"Recruitment period: February 2013-February 2014
~Number of recruitment sites: 7
~Types of location: medical clinic (3), hospital-based (4)"|
730639|NCT01751061||These numbers reflect primary and secondary surrogate decision makers, not patients, because surrogates were the focus of the trial.
730640|NCT01751022||"Out of the 1202 Intial enrollments; 77 were excluded due to to the following pre-implant events:
~unsuccessful cannulation (25)
~death (3)
~Exit prior to implant attempt (43)
~Attain Performa Lead implant not attempted (6)
~Resulting in 1125 subjects with Attain Performa Lead Implant Attempts"
730641|NCT01750931|Total 28 participants were enrolled from September-2013 to October-2013. At each study period participants received test (GlaxoSmithKline [GSK]-meloxicam 15 milligram [mg] tablet) and reference (Mobic®-meloxicam 15 mg tablet) products. Mobic is registered product of Boehringer Ingelheim Pharma GmbH and Company, Germany.|
730642|NCT01750840||
730643|NCT01750697|A total of 25 participants were enrolled in the study over a 3.5 year period from 11 sites across the United Kingdom, Italy, Serbia, Turkey, Canada and the United States.|The screening visit occurred up to 28 days prior to the Day 1 baseline visit. Following successful screening, eligible participants entered the 6 month Remission Induction Phase of the study.
730644|NCT01750684|A total of 15 subjects were enrolled. 2 subjects randomized to placebo were subsequently deemed ineligible and were not treated with the investigational product; they were excluded from the analysis. A total of 13 subjects received at least 1 infusion of the investigational product (AC105 and placebo) and were included in the Safety Population.|
730645|NCT01750502||Sequencing was carried out after polymerase chain reaction with DNA specimens from 186 volunteers without CHD and 70 patients with CHD. CHD was confirmed by Coronary Angiography (CAG).
730646|NCT01750398||
730647|NCT01750346||
730648|NCT01750294|Subjects were recruited from the VA Medical Center from Sept. 18, 2012 - May 15, 2013. Eligible subjects were ≥ 18 years of age with estimated glomerular filtration rate ≤ 45 but > 20 mL/min/1.73m2. The study initially recruited subjects with resistant hypertension but was amended to include those with poorly controlled but treated hypertension.|Prior to assignment, participants completed home blood pressure monitoring, ambulatory blood pressure monitoring, and a two-week run-in period, during which all subjects received a standard anti-hypertensive regimen based on the existing regimen of the subject.
730649|NCT01750281|Initially the study protocol allowed patients with KRASm (KRAS mutation positive), KRAS NMD (No mutation detected) and KRAS mutation status unknown. Recruitment was put on hold after the 77th patient was randomised in September 2013, to allow a protocol amendment to include only patients with centrally confirmed KRAS NMD NSCLC to be enrolled.|"The Protocol Section Enrolment Number of 466 includes 1 patient who was pre-screened twice. Of the 465 unique pre-screened patients, 337 gave informed consent and of these, 212 were randomised. 211 received at least 1 dose of treatment and were included in the safety analysis set. Patients received selumetinib (AZD6244; ARRY-142886) or Placebo."
730650|NCT01750268||
730651|NCT01750255||
730652|NCT01750242||Following enrollment but prior to analysis, MRIs were evaluated for readability. Those unreadable were excluded from analysis (N=3).
730653|NCT01750229|A total of 53 subjects were recruited between January 2013 and April 2015.|A total of 23 subjects discontinued prior to randomization due to eligibility criteria not met or withdrawal from the study.
730654|NCT01750086||
730655|NCT01749995||
730656|NCT01749982||
730657|NCT01749956|Between January 2013 and July 2014, 39 patients with stage II or stage III rectal cancer were enrolled in the trial from multiple sites in the U.S.|
730658|NCT01749930||
730659|NCT01749904||
730660|NCT01749826||
730661|NCT01749800||
730662|NCT01749735||Recruitment target (30) was not reached for this study. Inclusion/exclusion criteria were very restrictive hence making it difficult to recruit subjects.
730663|NCT01749631||A total of 97 participants were enrolled and included in the intent-to-treat (ITT) population; 1 participant did not meet the criteria Mallampati Score III or IV and was excluded from the per protocol population, which consisted of 96 participants.
730664|NCT01749605||
730665|NCT01749501|69 participants consented but only 45 needed the study procedure|
730666|NCT01749410||
730667|NCT01749293||
730668|NCT01749033||
730669|NCT01748955||
730670|NCT01748942||
730671|NCT01748916|Recruitment was carried out at the University of Costa Rica during June 2011 - August 2011.|Sixteen healthy, non-pregnant, non-smoking participants (21-44 y) were enrolled after checking eligibility, which was based on a questionnaire. Exclusion criteria included any history of chronic gastrointestinal disease, use of medications affecting lipid metabolism, regular use of carotenoid-containing supplements and frequent alcohol consumption.
730672|NCT01748890||
730673|NCT01748799||
730674|NCT01748760|Adolescent Psychiatric Inpatient Unit|
730675|NCT01748695||Included a 14-day period to exclude non-compliers, extremes of pain ratings, and those with high variability
730676|NCT01748643||
730677|NCT01748552||Single ascending dose crossover study with 2 parts and 3 periods per part. Part A had 3 cohorts (healthy participants). Part B had 1 cohort [with type 2 diabetes mellitus (T2DM)]. Participants in Part A, Cohort 3 completed 2 periods, as ninth (contingency) dose not tested based on interim data. There was ≥10 days between dosing for any participant.
730678|NCT01748292|Sixty patients were enrolled between February 2013 and January 2014.|
730681|NCT01748162|10 participants were recruited and consented and had their initial baseline bronchoscopy, but of the 5 at 1 site, only 1 had an actual croup episode within he first 6 months. Because of decreased recruitment, the study was terminated. The other site's data is not fully available due to unexpected staff turnover and systems failures.|
730682|NCT01748071||
730683|NCT01748045||
730684|NCT01747928||A total of 50 participants were screened, among whom 2 did not meet entrance criteria. The remaining 48 participants did and were randomized to study treatment.
730685|NCT01747915||The study was conducted at multiple sites in 21 countries in 219 participants between 03 April 2013 and 20 February 2019.
730686|NCT01747876|Approximately 64 patients were to be treated during the entire study; however, 32 patients were enrolled and treated at the time of the enrollment halt.|The escalation part of the study explored the 3 doses 280, 350 & 470 mg/m2) in successive cohorts. The dose expansion phase of the study was not conducted (due to enrollment halt).
730687|NCT01747850||
730688|NCT01747837|"First enrollment on Oct 22, 2015.
~Last enrollment on May 3, 2017 with last study visit date conducted on Jan 9, 2019,
~50 participants consented, 2 were found ineligible due to irregular renal anatomy during the angiography and not randomized."|
730689|NCT01747811||
730690|NCT01747772|Patients known to have or suspected of having diffuse liver disease who were scheduled for ultrasound-guided non-focal liver biopsy were eligible for the study.|
730691|NCT01747655||
730692|NCT01747629||Of the 361 patients screened, 158 were excluded on the basis of inclusion criteria, 5 on the basis of exclusion criteria, 13 withdrew consent, 1 patient was noncompliant, 2 patients were lost to follow-up before the baseline visit, 7 patients had other reasons, and 15 failed to meet the randomization criteria at the end of the run-in period.
730693|NCT01747551|Patients enrolled from January 2013 through April 2015.|
730694|NCT01747499||
730695|NCT01747486|First Patient Enrolled - 02-Jan-2013 Last Patient Completed - 13-Dec-2017|Study was conducted in 2 stages. Stage 1: subjects were randomized into one of the two arms (Arm 1: Higher dose & Arm 2 : Lower dose) Stage 2: the selected dose cohort was expanded to enroll additional subjects. Based on the Stage 1 analysis performed in Nov 2014, Arm 1 was chosen for expansion in Stage 2 and enrolled additional 12 subjects.
730696|NCT01747343|Four children were recruited from the Edna A. Hill Child Development Center at the University of Kansas from November 2012 until July 2013.|No children were excluded from the Study.
730697|NCT01747330||
730698|NCT01746979||
730699|NCT01746940|Subjects were recruited from patients scheduled for an office-based or operating room-based procedure or surgery on or through accessible mucous membranes of the nasal cavities.|A screening visit was conducted to ensure that each subject met inclusion/exclusion criteria for the study. Subjects who met all eligibility criteria were then enrolled on the drug application and procedure visit, which may have taken place on the same day as the screening visit.
730700|NCT01746901|Recreational opioid users who were not dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, were recruited in this study.|After successful naloxone challenge test, all participants underwent training sessions involving complete pharmacodynamics test battery before the drug discrimination phase, to ensure that participants fully understood how to perform the tests, were comfortable, and attained a stable level of performance on the various performance-based measures.
730701|NCT01746862||
730702|NCT01746784|17 Clinical Investigator Sites enrolled 66 subjects. The first patient was screened on March 5, 2013 and the last patient was seen on April 10, 2014.|There were 4 ascending dose cohorts starting at 5 mg and continuing with 10 mg, 20 mg and 40 mg. There was a fifth confirmatory cohort at the maximum tested dose, 40 mg. In Cohorts 1-4 approximately 9 subjects received N6022 and 3 received placebo. In the fifth cohort 11 subjects received N6022 and 7 subjects receive placebo
730703|NCT01746745||Participants completed study at 14 days postdose or earlier if ≥90% of administered radioactivity recovered or 24-hour (h) urine and fecal samples from 2 consecutive collections each had radioactivity levels <1.0% of total administered radioactivity in urine and feces combined.
730704|NCT01746732||
730705|NCT01746511||
730706|NCT01746420||
730707|NCT01746368|From May 2013 - September 2013, 50 subjects were recruited from outpatient clinics, rural mobile clinic, home-based primary care, and residential treatment units.|
730708|NCT01746264|Subjects were recruited between February 2013 and December 2013 at Mayo Clinic in Rochester, Minnesota.|
730709|NCT01746225|255 patients were randomized between 16April2013 and 7August2015 at 35 centers in 5 countries.|
730710|NCT01746173|5 patients were enrolled between July 2013 and January 2014.|
730711|NCT01746108|No healthy primed subjects were enrolled in the study.|
730712|NCT01746095||
730713|NCT01746043|Recruitment period: February 25, 2013 to January 5, 2017. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the 22 participants enrolled 1 participant were excluded from the study before assignment to groups: Of the 21 randomized patients, 19 (90%) were evaluable for the primary efficacy analysis.
730714|NCT01746017||This is a 2-part dose escalation study: Part A in healthy participants and Part B in participants with type 2 diabetes mellitus (T2DM). Participants in Part A participated in up to 4 intervention periods and participants in Part B participated in up to 3 intervention periods. There was an at least 8 days washout interval between each dosing.
730715|NCT01745952||
730716|NCT01745913||
730717|NCT01745848||All participants enrolled were assigned to the roflumilast group (no control arm of this study).
730718|NCT01745627||1 subject ID was never assigned, so the # of subjects who started the subject was actually 1 less than what the protocol said.
730755|NCT01743001|The study was conducted at 71 sites in 26 countries (geographical regions: Asia-Pacific, Eastern Europe, Latin America, North America, Western Europe including Israel and Turkey, and South Africa), of which 55 sites in 21 countries randomized subjects.|The screening period lasted a maximum of 30 days from Visit 1 up to Randomization (Visit 2). A total of 319 subjects were screened and 226 subjects were randomized to macitentan 10 mg and placebo.
730756|NCT01742949||
730757|NCT01742936||
730758|NCT01742897||
730719|NCT01745393|Pre-assignment clinic-level intervention and referral (recruitment): Across five pediatric primary care clinics in Philadelphia's three largest pediatric health systems (Temple University, Drexel University, and Children's Hospital of Philadelphia), 334 providers conducted the Ask, Advise, Refer clinic-level treatment implemented for this study.|Providers referred 2949 parents to the trial: 1280 were not eligible, 598 declined participation, 702 could not be contacted. Of 369 at baseline, 369 completed self-report assessments; 42 did not complete the pre-randomization home-visit child urine (cotinine) pick-up. Thus, 327 participants were randomized between the two treatment conditions.
730720|NCT01745380|Subjects were screened and enrolled at 3 sites in the U.S.|
730721|NCT01745367|Participants who met all the inclusion and none of the exclusion criteria were enrolled|"All participants underwent inclusion and exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures.
~The study was terminated prior to completing enrollment, hence descriptive statistical analyses were performed for a limited set of data."
730722|NCT01745146||After consent and T1 assessment, participants were randomized (2:1 Anger Self-Management Training or Personal Readjustment and Education) using a computer-generated table provided by the study's Data Coordinating Center, and assigned to the therapist corresponding to their treatment condition. Participants stratified by site.
730723|NCT01745133||5 screen failure
730724|NCT01745120|The study was conducted at 6 centers in the United States, Australia and Thailand between 05 September 2013 (first participant first visit) and 21 February 2018 (last participant last visit).|A total of 19 participants were enrolled in the study and made up the Intent-to-Treat (ITT) population, which included all participants who initiated any study procedures, beginning with mobilization by granulocyte-colony stimulating factor (G-CSF), with or without plerixafor.
730725|NCT01745094|Participants with overactive bladder (OAB) were enrolled in 29 sites in Japan.|
730726|NCT01745055||
730727|NCT01744977||
730728|NCT01744860|The study was conducted from 12 December 2012 to 03 April 2013 which evaluated 420 samples for detection of BRAF V600 mutation in France laboratories.|A total 420 melanoma tumor samples were analysed in 12 platform laboratories in France. The paraffin-embedded tumour samples were taken from biopsy or surgical specimen from the internal or external pathology laboratory.
730729|NCT01744821|Eligible participants were women at high risk for ovarian cancer and undergoing a prophylactic salpingo-oophorectomy. Subjects were recruited in the outpatient gynecologic oncology clinics of the study investigators. The study opened 6/1/12 with a goal of 80 subjects. It closed on 1/12/15 with a total of 7 subjects.|Baseline evaluation included physical examination, personal and family history questionnaire, and blood test including serum 25(OH)D. Based on vitamin D level, subjects were randomized to 1 of 4 groups.
730730|NCT01744782||Safety Population: All participants who received at least 1 dose of RP103.
730731|NCT01744730|Eligible participants (inpatients) were recruited in 4 hospitals in the United States. All participants were required to be receiving intravenous (IV) Clindamycin.|Patients between the ages (and inclusive of these ages) of 2 years to 17 years at time of first dose of study medication were screened for all other inclusion and exclusion criteria which includes must have body mass index (BMI) greater than or equal to 85th percentile for age and sex, based on Centers for Disease Control (CDC) recommendations.
730732|NCT01744704||
730733|NCT01744691||One hundred forty-five subjects were enrolled and 144 subjects received at least 1 dose of PCI-32765 and constitute the all treated population and the safety analysis set.
730734|NCT01744665||
730735|NCT01744574||
730736|NCT01744496|The study was conducted in Europe and USA. Recruitment was planned to continue until approximately 64 patients were randomized in the study. Subjects were randomized in a 1:1 ratio to either Rotigotine or Placebo. To achieve this, approximately 28 investigational sites were planned to participate in this hypothesis-generating pilot study.|The Participant Flow population refers to the Randomized Set (RS). The RS includes all subjects who were randomized.
730737|NCT01744483|Patients undergoing emergency tracheal intubation. EMS routed Harborview Medical Center (HMC) or patients who required emergent tracheal intubation while in HMC.|
730738|NCT01744392||
730739|NCT01744353||
730740|NCT01744340||
730741|NCT01744197||
730742|NCT01744093||Of the 61 subjects enrolled into the study, 34 subjects did not pass screening.
730743|NCT01743976||
730744|NCT01743963||
730745|NCT01743859||
730746|NCT01743729||"Two of 720 participants were excluded from data analysis due to duplication. Therefore, 718 participants were randomized and treated. One participant from placebo arm (N=360) has taken study drug by mistake and considered for Lifitegrast arm (N=358). Therefore, Placebo (N=359), Lifitegrast (N=359) were considered for safety analysis."
730747|NCT01743677||
730748|NCT01743560||Sixty-seven patients were screened and 52 patients were enrolled.
730749|NCT01743521||
730750|NCT01743469|Patients were recruited from 24 investigational sites in Belgium, Canada, the United Kingdom, Spain and France. The first patient was enrolled in December 2012 and the study was completed in April 2016.|In the hepatocellular carcinoma cohort 67 patients were screened, of whom 53 were treated with tasquinimod. In the ovarian carcinoma cohort 63 were screened, of whom 55 were treated. In the renal cell carcinoma cohort 44 were screened, of whom 38 were treated. In the gastric carcinoma cohort 27 were screened, of whom 21 were treated.
730751|NCT01743131||All 7/8 patients are compared to a historical control group (127 controls) from the Center for International Blood and Marrow Research (CIBMTR) registry. One 7/8 patient was randomized to receive placebo and was removed from data analysis. 186 patients were enrolled and 185 were included in analysis (313 - 127 -1 = 185).
730752|NCT01743092||
730753|NCT01743040|Recruitment was held June 14, 2013 through February 10, 2016 at hospitals, clinics and research centers.|
730754|NCT01743027|Participants were recruited from 6 study centers located in the US.|Of the 902 enrolled, 557 participants discontinued prior to randomization due to screen failure (390), adverse event (12), lost to follow-up (26), protocol violation (2), withdrawal by patient (85), and other (42). This reporting group includes all randomized participants (345).
730795|NCT01739790||
756359|NCT00316355||
730759|NCT01742832|The Enrollment number in the Protocol Section (79) conflicts with the number of participants Started in the Participant Flow module (48) because the assessment of interested was the double-blind portion of the study. Only 48 subjects were enrolled in this phase of the study, while 79 were enrolled in the preliminary open-label phase.|The results reported are for the double-blind phase, not the open label citalopram phase of the study.
730760|NCT01742364|"Infants: 131 consents obtained; 50 screening failures, no participation refusals, and 66 enrolled at birth. 15 infants were consented, screened, and eligible for participation but were not enrolled because the enrollment target had been reached.
~Adults: 95 consents obtained; 63 screening failures, 2 participation refusals, and 30 enrolled."|
730761|NCT01742286|Eighty-three patients were treated at different dose levels in both fasted and fed states dose escalation and expansion groups.|At least 15 patients for the fasted dose escalation & 12 patients for the fed dose escalation were expected to be treated. During the expansion part, approximately 45 patients were planned to be treated on the preferred regimen, approximately 25 patients in group 1 on the preferred regimen, and approximately 20 patients in group 2.
730762|NCT01742208|The study was conducted at 7 sites in United States between 08 February 2013 and 13 January 2014. A total of 36 participants were enrolled and treated in the study which consisted of 2 groups: Pioneer Group and Expansion Groups.|In this study, first 3 participants (Pioneer Group) received open-label sotagliflozin. Once dosing was completed in Pioneer Group, 33 different participants were randomized in 1:1 ratio to Expansion groups (sotagliflozin or placebo). Randomization was stratified according to baseline glycosylated hemoglobin (A1C [<=8 percent {%} vs. >8%]).
730763|NCT01742091||
730764|NCT01742078||
730765|NCT01742065|This cluster randomized pragmatic clinical trial was conducted in 26 federally qualified health center clinics, representing 8 health centers in Oregon & California, randomized to intervention (n = 13) or usual care (n = 13). All participants were overdue for colorectal cancer (CRC) screening at some point during accrual interval 2.4.2014-2.3.2015.|There were 62,155 participants enrolled in the entire study, but 41,193 in the primary analysis.
730766|NCT01741792|"Adults with a diagnosis of diffuse large B-cell lymphoma (DLBCL) which was refractory to first or subsequent treatment or who had a first or later relapse and were not eligible for autologous hematopoietic stem cell transplant (HSCT), or relapsed after autologous HSCT were eligible to enrol.
~The primary analysis cut-off date was 10 July 2014."|The study was conducted sequentially in 2 stages and 3 cohorts: In Stage 1, Cohort 1 received an escalating dose of 9/28/112 µg/day blinatumomab and Cohort 2 received a constant dose of 112 µg/day for 8 weeks. In Stage 2, the Cohort 3 dose regimen was determined from the outcome of Cohorts 1 and 2.
730767|NCT01741701||
730768|NCT01741688||
730769|NCT01741545||A total of 71 participants were enrolled, of which 51 subjects were randomized and treated.
730770|NCT01741532|Patients were recruited at 4 study sites in Germany, Italy, the U.K., and the U.S.|
730771|NCT01741480||
730772|NCT01741454||The enrollment is slow, drop out rate is high, thus, we decide to stop enrolling.
730773|NCT01741350|A total of 648 participants were screened from March 2007 through August 2010 from a methadone maintenance program in New Haven, Connecticut.|292 participants did not meet the study's inclusion criteria, 36 participants missed the initial interview appointment, and 16 participants were ineligible due to already being enrolled in another study.
730774|NCT01741272||
730775|NCT01741259||5 Patients were excluded after enrollment but prior to randomization. 3 were due to not having an epidural in place after surgery - 2 had accidental intrathecal catheter placement and 1 was to be started on lovenox. Another had a missing consent form and the other was started on magnesium sulfate which was an exclusion criterion.
730776|NCT01741012||
730777|NCT01740817||12 of 52 participants were randomized. Of those not randomized, 40 did not meet inclusion criteria.
730778|NCT01740791|Participants were enrolled at study sites in United States. The first participant was screened on 06 November 2012. The last study visit occurred on 24 January 2014.|163 participants were screened. Participants were not enrolled in 'Velpatasvir up to 400 mg genotype (GT) 2' group.
730779|NCT01740726||Two subjects were screen failures and were not randomized into either arm of the study.
730780|NCT01740713|A total of 23 children affected by transfusion-dependent haemoglobinopathies were enrolled in this study. Of these 23 children, 2 were screening failures and 3 early terminations.|
730781|NCT01740440||
730782|NCT01740427|Between 28 February 2013 and 29 July 2014, 666 women were randomized at 186 sites in 17 countries.|The study consisted of a screening visit within 28 days before randomization, an active treatment phase, divided in cycles of 28 days each, and a post-treatment follow-up period during which survival and new anti-cancer therapy information was collected every 6 months (±7 days) from the last dose of study treatment.
730783|NCT01740414||
730784|NCT01740401||
730785|NCT01740388||
730786|NCT01740362||
730787|NCT01740323||
730788|NCT01740297|"This study was conducted at 33 centers in the United States of America, France, and Germany.
~Particiants were enrolled in phase 1b from 07 February 2013 to 08 July 2013 and in phase 2 from 13 August 2013 to 25 February 2016."|In phase 1b all participants received talimogene laherparepvec in combination with ipilimumab. In phase 2 participants were randomized 1:1 to receive talimogene laherparepvec plus ipilimumab or ipilimumab. Participants were stratified by disease stage and either v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutation V600E or prior therapy.
730789|NCT01740258||
730790|NCT01740206||Two subjects with unknown ADHD medication status were excluded from the analysis.
730791|NCT01740154||
730792|NCT01740128||
730793|NCT01740089||
730794|NCT01739803|RTRs were enrolled between January 2010 and September 2011 and followed for one year (the study or intervention period). All active participants completed the study by September 2012; however, refill records were collected for three months following the end of the study period to calculate a follow-up (post-intervention) adherence rate.|Inclusion criteria: (a) at least 21 years of age; (b) at least one year post-transplant to allow for stabilization of the prescribed IST regimen; (c) receive an immunosuppressant regimen that contains oral tacrolimus or cyclosporine; and (d) obtain their IST from Avella for at least one year prior to study enrollment and during the study period.
730798|NCT01739400|The study was conducted at 51 sites in 19 countries (geographical regions: Asia-Pacific, Eastern Europe, Latin America, North America and Western Europe).|217 of 221 subjects (111 macitentan, 110 placebo) that completed treatment in the AC-055-305/MAESTRO double-blind (DB) parent study (NCT01743001) were enrolled in the open-label (OL) study without knowledge of their study treatment allocation in the DB study (macitentan or placebo).
730799|NCT01739361||
730800|NCT01739348|Part I began by enrolling approximately 50 participants per arm (200 total). Enrollment continued until the first 200 participants reached 13 weeks treatment; total enrollment at that time: ~400. For these ~400 participants (Safety Cohort), an interim analysis (IA) was conducted to assess safety. Following IA, enrollment continued (Main Cohort).|2211 participants were randomized in Part I, with 2210 receiving treatment. As planned per protocol, no participants were randomized to the Verubecestat 60 mg arm (Arm C) in the Main Cohort. Participants completing Part I were eligible to continue to Part II. The trial was terminated early and did not complete as planned.
730801|NCT01739335||
730802|NCT01739309||Completers are those who died, or are alive and being followed at the end of the trial but off treatment.
730803|NCT01739231||
730804|NCT01738984||
730805|NCT01738971|"Recruitment from end April 2012 - end December 2012 (8 month period). Recruitment of participants by community pharmacists within 11 community pharmacies in Edinburgh.
~All participating pharmacists trained by the research team prior to commencing recruitment of participants."|
730806|NCT01738919|Patients recruited after referral of mallet fractures from the emergency department Aarhus University Hospital to the department of hand-surgery Aarhus Universityhospital.|
730807|NCT01738750||
730808|NCT01738737||
730809|NCT01738698||Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
730810|NCT01738672||
730811|NCT01738646||48 participants signed consent. 8 participants are considered screen failures. 40 participants received treatment.
730812|NCT01738594|The study opened for accrual on December 19, 2012 with the first patient being enrolled on March 22, 2013 and an accrual goal of up to 48 patients. The study was designed as a dose escalation with 3+3 cohorts and two arms. The study was closed to further accrual of patients on September 13, 2016 due to slow accrual.|
730813|NCT01738581||
730814|NCT01738503||A total of 395 subjects provided informed consent to participate in the main study and underwent screening procedures. Of these 395 subjects, 124 received study treatment.
730815|NCT01738477||
730816|NCT01738438|Patients enrolled from January 2013 through June 2014.|
730817|NCT01738321||
730818|NCT01738191||
730819|NCT01737996||The 600mg dose cohort was to be started at least 6 days after the 400mg dose cohort was completed and the combined treatment cohort (600mg Deleobuvir + 120mg Faldaprevir) was started after the evaluation of key safety and tolerability data of the individual treatments.
730820|NCT01737944|Subjects were screened and enrolled at 2 sites in the US. Approximately equal number of subjects on 10 mg, 15 mg, 20 mg and 25 mg doses were recruited. The dose group was determined by the Investigator based on subject's current therapeutic regimen of MTX and disease status. The patient's dose was the same for the entire study.|The order of Methotrexate (MTX) treatment arms (A-SC injection with Vibex-MTX device, B-SC injection without device and C-IM Injection) were randomly assigned and dosing was separated by interval of atleast 7 days to allow for washout before the next treatment was administered.
730821|NCT01737931||A total of 120 eligible subjects received the IMP treatment at least once, and 3 of them were withdrawn from the trial before topical treatment allocation due to subject request (1 subject) and for lack of efficacy evaluation (2 subjects).
730822|NCT01737879|First patient was enrolled on 24 October 2012; Last patient was enrolled on 21 February 2013. The study was terminated on 27 March 2013.|
730823|NCT01737840||
730824|NCT01737762|Subjects were screened at 36 sites in the US and 3 in Canada; between November 30, 2012 and November 11, 2015; sites included independent and hospital wound clinics and private practice sites.|Subjects entered a 2-week run-in; subjects whose wound radius decreased by < 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization. After completion of the treatment period, subjects entered a three-month follow up period.
730825|NCT01737710|464 participants between the ages of 18 to 64 years were recruited and 368 of those participants were enrolled at 5 sites in the US between 10/2012 and 03/2013|
730826|NCT01737697|Participants took part in the study at 65 sites (up to 100 sites initially planned in Protocol) in the United States, Australia, and South Africa from 25 November 2012 to 29 October 2013.|In the acute phase, 754 subjects were randomized; 753 were treated. Subjects who completed the AP and had i-STAT K+ values within normal range in a.m. of Study Day 3 could enter the Subacute Phase. 543 subjects entered the subacute phase.
730827|NCT01737684||This study was planned to be conducted in two parts. Part 1 was to include participants with moderate hepatic insufficiency and healthy participants. Part 2 was to include participants with mild hepatic insufficiency. After a review of the safety and pharmacokinetic data from Part 1, a decision was made not to conduct Part 2.
730828|NCT01737593||
730829|NCT01737398||Participants randomized: 113 inotersen and 60 placebo; received study treatment: 112 inotersen and 60 placebo. This study consisted of a 65-week Treatment Period, 1-week End of Treatment (EOT) Period, and a 6-month Post-treatment Evaluation Period.
730830|NCT01737281||
730831|NCT01737268|Elderly participants with documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision criteria for bipolar I disorder or bipolar II disorder, with most recent episode depressed confirmed by the Mini-International Neuropsychiatric Interview were recruited from 32 sites in Japan.|Participants who were not taking quetiapine or was at < 50 mg/day at least 28 days prior to informed consent, FK949E was administered at an initial dose of 50 mg during the dose-titration period. Participants who were taking quetiapine at 50 to < 300 mg/day or 300 mg/day, FK949E was administered at 150 mg/day during the dose-titration period.
730832|NCT01737021||
730876|NCT01734434|Subjects were enrolled at Dominican Republic, Panama, Mozambique, and South Africa.|All enrolled subjects were included in the trial.
752172|NCT00550732|The study was conducted in 8 medical centers across Canada.|
730833|NCT01736930|The study was conducted at Stanford University and the Barbara Davis Center. A total of 20 subjects were enrolled between January 1, 2012 and June 30, 2012. Nineteen participants 18-56 years old with type 1 diabetes (HbA1c 6.0%-7.7%) completed the trial.|After the run-in phase, a 21-night randomized trial was conducted in which each night was randomly assigned 2:1 to have either the predictive low glucose suspend system active (intervention) or inactive (control). Participants were current users of the MiniMed Paradigm® REAL-Time Revel™ System and Sof-sensor® glucose sensor at time of enrollment.
730834|NCT01736917||
730835|NCT01736865||"127 participants were enrolled because by the time the 124 needed was reached, 3 additional participants were eligible and wanted to be part of the trial."
730836|NCT01736852||
730837|NCT01736696||
730838|NCT01736683|Participants were stratified by concentration of serum erythropoietin (EPO) (<500 versus ≥500 IU/L), by number of transfusions within 56 days of study enrollment (<4 versus ≥4 units of red blood cells) and assigned randomly to 0.1 mg/kg and 0.3 mg/kg arms.|Enrollment in the other arms (sotatercept 0.5, 1.0 and 2.0 mg/kg arms) commenced after the Steering Committee approved the higher doses based on the safety of preceding doses.
730839|NCT01736657|Recruitment period: Nov 2012 through May 2013|"Evaluable population includes 60 pts. Terumo Optia Trainer was present for Optia Operator support for 12 procedures, called lead-in procedures: these were not included in efficacy analysis, but were included in safety analysis (full analysis set)."
730840|NCT01736579|Enrollment was conducted at one clinical site in the US.|Six participants were enrolled (i.e. signed informed consent form), of which 2 failed screening and 4 were treated with study product.
730841|NCT01736566|Participant recruitment began in 2012 at Brigham and Women's hospital by letter, email, phone and in person.|
730842|NCT01736553|12/2012 first subject enrolled, 9/2014 Enrollment Complete, 8/2015 Last Subject Visit|Subject's had staggered enrollment into the study based upon when identified with SMA. Participants could have visits at 0 and 3 months of age. We tried to enroll as early as possible, but only reported the data starting at 6months. 6 months was when the official visits began.
730843|NCT01736540||
730844|NCT01736527|Single center, open label, single dose study in healthy volunteers. First participant enrolled 01/08/2013, last participant exited: 01/18/2013.|A total of 17 participants were screened for this study. Of those screened, 12 participants were included to receive treatment; these subjects constituted the Safety population. No participants discontinued from the study.
730845|NCT01736475|Participants were enrolled (signed informed consent) at 72 sites.|A total of 159 participants provided informed consent and were screened for study participation, of which there were 21 screen failures. 138 participants were assigned to the prophylactic arm or the on-demand treatment regimen.
730846|NCT01736397||
730847|NCT01736358||
730848|NCT01736267||
730849|NCT01736254||
730850|NCT01736241||
730851|NCT01736215||
730852|NCT01736189||All registered participants
730853|NCT01736176|This study was conducted at 12 sites in the United States that specialized in movement disorders. Participants were levodopa-responsive with advanced Parkinson's disease (PD) and persistent motor fluctuations despite attempts to optimize treatment with oral levodopa-carbidopa and other available anti-PD medications.|During screening participants converted their current daytime levodopa-carbidopa doses to oral levodopa-carbidopa 100/25 mg immediate release (LC-IR); other anti-PD medications could be continued, reduced or discontinued at the investigator's discretion. LC-IR and all other anti-PD treatments were discontinued at LCIG initiation.
730854|NCT01736085||
730855|NCT01735994|Study enrollment began at the schools in August 2012 and completed in October 2014.|Only one athlete decided to participate in the prevention program without participating in the study.
730856|NCT01735916||
730857|NCT01735877|Recruitment period: January 2011 to August 2013|
730858|NCT01735630||
730859|NCT01735617||
730860|NCT01735396|Recruitment began in Dec 2012, with enrollment from April 2014 to March 2016.|
730861|NCT01735279|Data were collected in São Paulo/Brazil between January 2013 and August 2013. All participants signed an informed consent prior to the beginning of the study. The participants did not receive any kind of compensation for participation in the study.|No participants were excluded.
730862|NCT01735214||
730863|NCT01735201||357 patients were randomized; 1 patient in error. 356 patients were included in the Modified intent-to-treat and Safety populations.
730864|NCT01735175||
730865|NCT01734993|A total of 12 participants were screened at 6 sites in France, of which 11 participants were enrolled.|
730866|NCT01734902|Randomised, single-dose, open-label, two-way crossover trial in healthy volunteers to investigate and compare the relative bioavailability of two formulations of hyoscine butylbromide administered orally as drops (T: test treatment) or as sugar-coated Buscopan® tablets(R: reference treatment).|All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
730867|NCT01734889|The study recruitment was performed at seven medical clinics in three countries (United Kingdom, Germany and France). First subject was enrolled on 09 November 2012 and last subject´s last visit was on 01 March 2013.|
730868|NCT01734850||
730869|NCT01734811|October 2012 - May 2015 subjects enrollment. 120 children <3 years old with recurrent WA, defined as 3 or more episodes of WA during the previous year. . WA were confirmed by the review of the medical records. Aeroallergen sensitization at baseline was used as an exclusion criterion to avoid an eventual WA due to allergic asthma.|
730870|NCT01734785||16-week open-label (OL) lina 5 period followed by a 1-week OL period with additional placebo administration preceded randomisation to double-blind treatment. Patients were randomised to double blind treatment only when they had not met glycaemic control criteria after the 16-week OL period. All treatments were administered in addition to metformin.
730871|NCT01734772||
730872|NCT01734746||
730873|NCT01734655||
730874|NCT01734551||
730875|NCT01734525||
752173|NCT00550680||
752174|NCT00550654||
730877|NCT01734395|1,882 participants were recruited to the 84 study centers.|Out of 1,882 participants, 489 participants violated the inclusion/exclusion criteria and were excluded from the full analysis set (FAS). 1,472 participants completed the study. Total 1,393 participants were included in the FAS population.
730878|NCT01734382|Participants with systemic juvenile idiopathic arthritis (sJIA) were recruited at study sites in 8 countries. The study consisted of two parts: Part 1 was a 24-week Run-in period and Part 2 was a 52-week Main study.|Participants on tocilizumab (TCZ) once every two weeks (Q2W) who had experienced a laboratory abnormality (which resolved) as per protocol criteria either during Part 1 or prior to the study, could enter Part 2. 19 Participants entered Part 1 and 6 continued on to Part 2. 16 participants directly entered Part 2 of the study.
730879|NCT01734317||
730880|NCT01734239||
730881|NCT01734161||
730882|NCT01733953||
730883|NCT01733758|A total of 494 participants (par.) were randomized to one of the four treatment groups - placebo (switched to albiglutide 30 mg at Week 24), albiglutide 30 mg, albiglutide 50 mg, liraglutide (open label), 490 par. took at least one dose of study drug (Safety Population). All 490 par. were included in Intent-to-Treat Population.|
730884|NCT01733745|Participants were recruited from 1 study center located in the US.|This reporting group includes all subjects who were enrolled and received at least one of the study treatments (26).
730885|NCT01733732|Subjects were recruited from 1 study center located in the US.|A total of 54 subjects were screened and randomized. This reporting group includes all randomized subjects (54).
730886|NCT01733680|Subjects were recruited via a medical clinic and outside advertisement. Due to the stringent inclusion/exclusion criteria, we were only able to recruit 3 subjects and the physician who was conducting the study chose not to continue and we were unable to find another physician.|
730887|NCT01733628|From October 2012 to July 2016, 143 patients were included.|
730888|NCT01733472||
730889|NCT01733407||
730890|NCT01733368||
730891|NCT01733329||
730892|NCT01733316||
730893|NCT01733277||
730894|NCT01733238|The study was initiated in November 2012 and the first subject was enrolled on 22 January 2013. A total of 15 subjects were screened. Subjects were enrolled at oncology clinics in the USA.|
730895|NCT01733212|Enrollment period: June 03, 2010 to April 12, 2011 Location: New York Methodist Hospital, Department of Obstetrics and Gynecology|
730896|NCT01733121|This study enrolled patients with schizophrenia or schizoaffective disorder with tardive dyskinesia (TD), a mood disorder with TD, or a GI disorder with TD from 29 centers in the United States and Puerto Rico. The last patient completed in December 2013.|
730897|NCT01733069|A total of 1912 male and female subjects were enrolled under this protocol. Of the 1912 subjects, 1862 were evaluable for analysis of CT or GC performance (conclusive infected status and at least one valid PANTHER Combo 2 Assay result)|Fifty (50) of the 1912 eligible subjects did not have a conclusive infected status or a valid Panther Combo 2 Assay result and are not included in the results below.
730898|NCT01733056|43 subjects enrolled from Dept of dermatology, including 21 normal controls, 12 patients on TNF blockers for the treatment of skin diseases, and 10 patients treated with azathioprine for the treatment of skin diseases. Both serologic and cell based assays were completed before and after vaccination on all subjects.|
730899|NCT01732926|Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 02 January 2013. The last study visit occurred on 17 May 2016.|581 participants were screened.
730900|NCT01732913|Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 16 January 2013. The last study visit occurred on 18 May 2016.|385 participants were screened.
730901|NCT01732835||
730902|NCT01732822|This study was conducted at 821 centres randomising patients across 28 countries. The first patient was enrolled on 04 December 2012. The last visit of the last patient took place on 26 September 2016. In total, 16237 patients were screened.|Screened patients randomised to study drug: 85.5%; n=13885 Patients who were not randomised: 14.5%; n=2352 Patients with inclusion criteria for symptomatic lower extremity PAD failed: n=489 Patients with poor metabolizer status for CYP2C19: n=616 Patients with other reason: n=1374
730903|NCT01732809||
730904|NCT01732796|It was planned that approximately 800 patients would be screened in order to randomize and treat approximately 460 patients (195 patients in treatment Groups 1 and 2 each, 40-70 patients in treatment Group 3).|Treatment-naïve patients with chronic hepatitis C infection of genotype (GT)1b were included in the trial. Patients with compensated liver cirrhosis, defined as Ishak Grade ≥5 or METAVIR Grade ≥4 on liver biopsy, or liver stiffness of ≥ 13 kilopascal (kPa) on fibroscan, were assigned to Group 3.
730905|NCT01732783|The study was conducted in France and Germany between 10 December 2012 and 30 November 2016.|
730906|NCT01732770|This study was conducted at 37 centers in Belgium, Denmark, Poland, Spain, Canada, United States of America, and Australia. The first participant enrolled on 07 November 2012 and the last participant enrolled on 15 January 2014.|Participants were randomized in a 1:1 allocation ratio to receive either denosumab or zoledronic acid. Randomization was stratified by screening serum type I collagen C-telopeptide (sCTX) values (< 0.3 ng/mL, 0.3 to 0.5 ng/mL).
730907|NCT01732757||
730908|NCT01732718||
730909|NCT01732692|Participants took part in the study at 6 investigative sites in the Russian Federation and the Republic of Kazakhstan from 22 November 2012 to 5 April 2013.|Participants indicated for a colonoscopy were enrolled equally in 1 of 2 treatment groups, morning-only on the day of the clinical procedure or split-dosing in 2 stages with a nocturnal pause.
730910|NCT01732640||
730911|NCT01732627|Study was conducted from 12-November-2012 to 17-January-2013 at 12 sites in the United States.|A total of 301 participants were enrolled and vaccinated in the study.
730912|NCT01732588||
730913|NCT01732549|The study was performed as a multicentre study at 51 investigational sites (of which 44 randomised patients) in Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Lithuania, Poland, Spain and United Kingdom (UK)|A total of 219 patients were screened and 144 patients were randomised.
732516|NCT01630109|Study subjects were recruited from December 2012 to June 2013. The subjects were recruited in the Medical Procedures Unit at Genesys Regional Medical Center.|No events to report.
730914|NCT01732536|Patients were enrolled between January 2013 and November 2013 at 18 clinical sites (12 private, 6 academic).|A total of 100 patients were enrolled and randomized. met final eligibility. There was a 2-week run-in period before screening during which participants were required to use an intranasal corticosteroid spray.
730915|NCT01732510||Participants were screened for study eligibility over 4 weeks prior to first dosing. Additional inclusion and exclusion criteria applied.
730916|NCT01732484||
730917|NCT01732471||
730918|NCT01732458||Of 262 screened for inclusion, 229 were randomized to treatment. 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose arm that was not evaluated in this study; therefore the participant was not included in any analyses. Of remaining 228 randomized participants, 8 did not receive treatment.
730919|NCT01732445||
730920|NCT01732419||
730921|NCT01732406||
730922|NCT01732263||One subject withdrew from study prior to randomization (n = 43).
730923|NCT01732211||In Part A, approximately 22 subjects were to be enrolled to receive PD 0360324 100 mg once every 2 weeks (Q2W)/150 mg Q2W. In Part B, approximately 66 subjects were planned to be enrolled to receive PD 0360324 (either 100 or 150 mg Q2W defined in Part A) B.
730924|NCT01732107||
730925|NCT01731990||A total of 38 patients were enrolled into the study.
730926|NCT01731938||
730927|NCT01731912||16 started therapy. 14 completed therapy
730928|NCT01731886||
730929|NCT01731691|Volunteers were recruited by ACRIA by placing advertisements in neighborhood publications. A total of 227 patients were interviewed as potential candidates. The first study candidate was screened on January 14, 2013 and the first HIV+ subject was randomized (treatment/placebo) on April 25, 2013.|Of the 21 potential subjects screened, 12 (57%) reached the baseline visit. All 12 were enrolled and all completed the study.
730930|NCT01731678||
730931|NCT01731600|The trial was conducted at 36 sites in 15 countries as follows: Canada (1), France (2), Germany (1), Greece (2 sites screened/1 site randomised subjects), Israel (1), Italy (1), Japan (2), Lithuania (1), Malaysia (1), Portugal (1), Switzerland (3), Turkey (3), Ukraine (2), United Kingdom (3), and United States (12).|
730932|NCT01731470||
730933|NCT01731171||
730934|NCT01731119||
730935|NCT01731041|Patients were screened at the Division of Cardiology of the University Of Florida College Of Medicine - Jacksonville|
730936|NCT01731002||
730937|NCT01730950||
730938|NCT01730872||
730939|NCT01730846||
730940|NCT01730729|The study opened for accrual on November 29, 2012 with an accrual goal of up to 20 patients. The first patient starting treatment February 11, 2013. Accrual was suspended twice during the study; May 28 2014 reopening June 11, 2014 and July 24 2015, reopening August 27 2015. The study was closed October 21, 2015 with 20 patients enrolled.|
730941|NCT01730586|Recruitment Period: November 2012 to October 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|
730942|NCT01730534||
730943|NCT01730378||
730944|NCT01730339||A total of 103 participants were randomized into the study. Of these, 100 participants received at least 1 dose of study drug and were included in the modified intent to treat (mITT) and safety population.
730945|NCT01730053|The study was conducted at 79 sites in 8 countries. Overall, 672 participants were screened between 24 October 2012 and 27 September 2013, 367 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.|Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, and intensity of statin treatment (rosuvastatin 10 or 20 mg). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System (IVWRS) in a 1:1:1:1:1:1 ratio after confirmation of selection criteria.
730946|NCT01730040|The study was conducted at 85 sites in 9 countries. Overall, 859 subjects were screened between 24 October 2012 and 26 September 2013, 504 of whom were screen failures. Screen failures ware mainly due to exclusion criteria met.|Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, and intensity of statin treatment (atorvastatin 20 or 40 mg). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1:1:1 ratio after confirmation of selection criteria.
730947|NCT01729923|This study was activated on March 30, 2013 and terminated on August 12, 2016 due to lack of funding and prior to reaching its enrollment goal. A total 27 participants were accrued.|
730948|NCT01729871|Participants were randomized at 37 sites in 5 countries.|248 participants were randomized correctly to study, with an equal number of participants randomized to both treatment arms. The intention to treat (ITT) analysis set includes all participants who were correctly randomized into study. There are 5 screen failures who were not included in ITT analysis set because they were incorrectly randomized.
730949|NCT01729845||
730950|NCT01729819|This was a multi-centre trial conducted in the US. A total of 33 sites were initiated in this trial, and of these eligible patients from 20 sites were randomised to a treatment. The first patient first visit was on 28 January 2013. The last patient last visit was on 19 November 2014.|The trial was initiated with a screening period of 3-4 weeks between Visits 1 and 2a, where no investigational medicinal product was taken. Patients who were on a prohibited medication and needed a wash-out period of 1-2 weeks initiated the trial at Visit 0. Eligible patients were randomised to one of the two treatment groups at Visit 2a.
730951|NCT01729754||The tables below present the Participant Flow for the Base Study only (Weeks 0 to 52: Part 1 for 12 weeks, Part 2 for 16 weeks, and Part 3 for 24 weeks).
730952|NCT01729728|The first participant was enrolled on the 15 Nov 2012 and the last participant completed the trial on the 24 Feb 2014.|Consent was obtained for 86 participants in the trial. 66 participants were allocated and received study drug (investigational medicinal product). Pharmacokinetic data was obtained for the planned 56 participants.
730953|NCT01729598||
730989|NCT01727024||Total number of participants randomized to the study was 140. However, one participant did not meet an exclusion criterion. Therefore, the starting numbers in the participant flow reflect the 139 eligible randomized participants.
730990|NCT01726803||
732517|NCT01629966||
732518|NCT01629953||
732519|NCT01629862||
730954|NCT01729559|From November 15, 2012 through September 15, 2014, consecutively admitted adult trauma patients were evaluated for eligibility for the study. Patients aged 18 years and older and at risk for Venous thromboembolic event (VTE) based on the American College of Chest Physicians guidelines were included.|Those with an estimated Injury Severity Score (ISS) equal to or less than 9, those expected to have a hospital length of stay less than seven days by reason of discharge or death, and prisoners were excluded.
730955|NCT01729338|17 subjects consented to the study. 1 subject was a screen failure.|
730956|NCT01729247|Participants expressing interest who met inclusion and exclusion criteria were asked to sign written informed consent prior to participation.|
730957|NCT01729208||
730958|NCT01729156||
730959|NCT01729039||
730960|NCT01729026|Enrollment opened in October 2013 and closed at the end of September 2014. Subjects learned about the study primarily from clinical staff or from posters and brochures that were distributed throughout the clinics of the South Texas Veterans Health Care System in San Antonio.|Two of the 22 consented subjects were not randomized: one left before he was evaluated and the second did not meet entry criteria. A third subject was randomized to the Adoption group but subsequently found not to meet criteria for PTSD, leaving 9 in this group and 10 in the Wait-List group.
730961|NCT01728844|Participants were recruited and enrolled at 6 dental clinical centers between November 2012 and December 2013.|
730962|NCT01728805||
730963|NCT01728792|Participants took part in the study at 1 investigative site in the United States from 22 January 2013 to 21 November 2013.|Healthy participants were randomized equally to 1 of 5 TDV treatment groups: 2 doses subcutaneous (SC) on Day 0 using needle/syringe, 2 doses intramuscular (IM) on Day 0 using needle/syringe, 1 dose IM on Days 0 and 90 using needle/syringe, 2 doses SC on Day 0 using the PharmaJet Stratis™ device and 2 doses IM on Day 0 using the PharmaJet Stratis™.
730964|NCT01728623||
730965|NCT01728584||"Participants were randomized to 4 arms based on combinations of neuromuscular blockade (NMB) depth and insufflation pressure level. During procedure, blinded surgeon could request that unblinded anesthetist change the randomized treatment conditions (rescue intervention), if surgeon considered surgical conditions to be unacceptable."
730966|NCT01728454||
730967|NCT01728376|Participants aged 1-17 with bacteremia caused by Staphylococcus aureus (S. aureus) were enrolled in this study.|
730968|NCT01728337|All patients included in this study were recruted from two research centers.|We did not have any drop-out in this study.
730969|NCT01728324||
730970|NCT01728246||
730971|NCT01728194||
730972|NCT01728116|Up to 500 subjects were planned to be randomized into either the EndoBarrier or the sham control arm at a 2:1 ratio, respectively. Due to early termination of the trial, only 325 subjects were randomized with 216 EndoBarrier subjects and 109 sham control subjects.|The mITT population for the primary analyses includes 213 EndoBarrier subjects and 107 sham control subjects. The remaining five (5) subjects (n=3 randomized to device; n=2 randomized to sham) were deemed ineligible before an attempted device placement due to findings identified during the upper endoscopy.
730973|NCT01728077|This study started to enroll subjects in October 2012 and concluded in August 2016.|Participant Flow refers to the Safety Set (SS), which consisted of all subjects who took at least 1 dose of study drug.
730974|NCT01727895|Recruitment took place from April until May 2013 in the Radboud University Medical Centre Nijmegen.|Exclusion of subjects was based on pre-defined exclusion criteria or the unability of subjects to comply with the study time schedule.
730975|NCT01727791|Eligible participants were healthy, lactating females between the ages of 18 and 45 years (inclusive) who were actively breastfeeding or expressing breast milk, who were at least 12 weeks post-partum and not currently pregnant.|
730976|NCT01727765||
730977|NCT01727726|Trial was conducted at 75 trial sites in 7 countries (United States, Russia, Poland, France, Serbia,Germany & Canada). Phase A non-responders entered Phase B (503 subjects randomized in 2:2:1 (197+100+206) ratio - brexpiprazole/Seroquel extended release tablets/placebo +ADT).|Screening period ranged from a minimum of 7 days to a maximum of 28 days and began when informed consent was signed. The purpose of the screening period was to assess eligibility criteria at 1 or more visits (as necessary to complete screening assessments) and to washout (minimum of 24 hours) prohibited concomitant pharmacotherapy, if applicable.
730978|NCT01727713|The trial was conducted in 110 participants at 37 trials sites in 4 countries. Participants who were aged 7 to 17 years at screening or who turned 18 years during their participation in Trial 31-12-293 (NCT01727700) were enrolled in this extension trial|
730979|NCT01727700|This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial in children and adolescents (aged 7-17 years) with Tourette's disorder (TD). 171 participants were screened, of which 133 were randomized to treatment.|The trial consisted of a pretreatment phase and a treatment phase. Pretreatment phase consisted of a screening and washout (when applicable) period. This was followed by an 8-week treatment phase starting with the baseline visit (Day 0). Particpants were randomized 1:1:1 to aripiprazole high dose, aripiprazole low dose or placebo.
730980|NCT01727505|This study was conducted at the Project NewBorn Neonatal Intensive Care Unit of the Jackson Memorial Hospital/University of Miami Medical Center. Subjects were recruited into the study between December, 2012 and September, 2014.|"42 infants were screened. Of these, 9 declined participation and 3 did not meet inclusion criteria.
~30 infants were enrolled (consented). Of these, 4 infants became ineligible after consent and were not studied.
~26 enrolled infants were studied."
730981|NCT01727414||
730982|NCT01727297||Patients in the 'No Reveal Implantable Cardiac Monitor Implant Attempt' arm were exited from the study prior to an implant attempt. Therefore, no outcome data are available. Baseline data are not presented due to variable data collection before the time of exit. Adverse event data were collected for this cohort, and are reported below.
730983|NCT01727258||
730984|NCT01727180||
730985|NCT01727167||
730986|NCT01727154||
730987|NCT01727141|Participants were randomized to each treatment arm in a 1:1:1:1 ratio.|One thousand forty two participants were randomized. (One participant was randomized twice and was counted twice in the randomized set.) In the safety set, participants were analyzed according to the treatment received.
730988|NCT01727089||
731176|NCT01713608||
730991|NCT01726738|A total of 17 participants were recruited from University of North Carolina Hospitals (Chapel Hill, NC) between January 2013 and July 2016|In addition to the 17 patients who were enrolled and participated in the trial, 6 additional patients consented, but were found to be ineligible and 1 additional patient withdrew consent prior to starting the study.
730992|NCT01726673||Subjects were randomized to receive 36 sessions of either active tDCS immediately followed by robotic arm therapy or sham tDCS immediately followed by robotic arm therapy.
730993|NCT01726621||
730994|NCT01726517|Participants were enrolled at 1 study site in the United States. The first participant was screened on 22 October 2012. The last participant observation was on 13 January 2014.|116 participants were screened.
730995|NCT01726504||
730996|NCT01726335||
730997|NCT01726270|Study had 2 parts: In part 1 participants reviewed the product label and responded to a question about whether the product is appropriate for them to use (self-selection), selected participants then entered part 2 where they recieved study product (actual use).|
730998|NCT01726049|Stabile outpatients with heart failure with preserved ejection fraction (HFpEF) and signs of pulmonary hypertension (PH) on echocardiogram were referred for right heart cath as part of clinical care. After heart catheter measurements , eligible patients were asked for participation. Recruitment from october 2011 until september 2014|
730999|NCT01726036|274 infants were enrolled into the study from 10/2012 through 6/2013.|
731000|NCT01726023|Overall, 486 patients were enrolled from 43 centers in 3 countries in this study. The first patient was enrolled on 14 January 2013 and the last patient last visit was on 14 March 2015.|Of 486 enrolled patients, 42 did not meet the eligibility criteria. A further two patients were not randomized due to withdrawn consent, and one patient was not randomized due to unavailability of study drug.
731001|NCT01725984|140 subjects were screened for inclusion into the study. 80 total subjects met all inclusion and none of the exclusion criteria.|
731002|NCT01725815||
731003|NCT01725750|From October 2015-January 2017, recruitment materials were sent to previous research and support group participants, and other local TBI centers. Information was also posted online and at consumer conferences. External sites included Centre for Neuro Skills facilities and post-acute rehab centers in Bakersfield and Los Angeles, CA, and Dallas, TX.|
731004|NCT01725529||
731005|NCT01725451||
731006|NCT01725386||274 participants were enrolled in the study; of these, 23 participants from 3 centers were excluded from the analysis due to study termination at those 3 centers. The remaining 251 participants were eligible for analysis.
731007|NCT01725308|Japanese patients with bipolar I or bipolar II as specified in Diagnostic and Statistical Manual of Mental Disorders Ver. 4 Text Revision (DSM-IV-TR) whose most recent episode was diagnosed as a major depressive episode using the Mini-International Neuropsychiatric Interview (MINI) were recruited for this study.|Assignment of participants to the FK949E 150 mg group was discontinued with implementation of Version 3.0 of the protocol.
731008|NCT01725282||
731009|NCT01725217|Subjects were enrolled at 5 centers in Russia|All enrolled subjects were included in the study
731010|NCT01725126|The study was conducted in 3 parts in healthy male and female participants aged 18 to 70 years in Part A and in participants with type 2 diabetes (T2D) in Part B and C across three centers of United States of America.|A total of 15 participants were randomized in Part A, 20 were randomized in Part B and 18 were randomized in Part C.
731011|NCT01724528|First patient in (screening) 01 Oct 2012, last patient out 11 Oct 2013. At 79 sites across 11 European countries (Croatia, Czech Republic, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain and Ukraine) and Brazil|Subjects complying with inclusion/exclusion criteria were to be randomised to receive (blinded) standard, low or high dose of study treatment as per investigator's assessment (mainly based on renal function). Randomization was balanced by TLS risk and serum uric acid levels (≤ or > 7.5 mg/dL)
731012|NCT01724489|Subjects were recruited from August 2013 to April 2017. Recruitment techniques included posting advertisements on the internet (i.e. Facebook and Craigslist) and on the Massachusetts General Hospital's clinical trial recruitment website.|Of the 253 people who signed a consent form, 165 were unable to participate due to various reasons including meeting ineligibility criteria. The 88 subjects remaining were randomized to one of two arms. Of these 88 subjects, a total of 77 subjects had baseline measurements collected.
731013|NCT01724359||Patients who received paliperidone extended-release (ER) at least once and provide at least 1 post baseline efficacy measurement will be included in the intent-to-treat (ITT) analysis set for efficacy. Patients who received paliperidone ER at least once and provide any post-baseline information will be included in the ITT analysis set for safety.
731014|NCT01724216|Subjects with orders from their doctor for an MRI were screened from Spectrum Health's Neurology Department. The study coordinator contacts each subject that met the inclusion criteria. If the subject is interested to volunteer, a copy of the Informed Consent was sent and appointment scheduled. Seg. 1 enrolled 11 subjects; no Seg. 2 enrollment.|This is a single arm study.
731015|NCT01724177||This study included Japanese participants with relapsed or recurrent adult T-cell leukemia (ATL) who had previously received anti- ATL chemotherapy and who were categorized as having acute-lymphoma or unfavorable chronic-type ATL.
731016|NCT01724060||There were no pre assignments requirements
731017|NCT01724021||A total of 743 participants were enrolled across all the sites and were included in the intent to treat (ITT) population. Three participants were enrolled but died prior to receiving study medication and were not included in the safety population. The Participant Flow represents the safety population.
731018|NCT01723904|This multicenter study started to enroll subjects in 5 countries in October 2012.|Participant Flow refers to the Safety Set (SS). SS consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
731019|NCT01723826|A total of 360 participants were enrolled at 83 sites across 6 countries.|Participants who completed either Phase II Study NCT01343966 (ABE4869g) or NCT01397578 (ABE4955g) and had Mini-Mental State Examination (MMSE) score of 10 or more at the time of screening were included. Participant flow is represented based on the safety population by treatment received.
731020|NCT01723722|Recruitment period 11/15/2007 through 9/1/2009; location Eastern Maine Medical Center NICU|Exclusion for other medical conditions causing withdrawal symptoms, gestation less than 35 weeks
752175|NCT00550615||
731021|NCT01723696|Study staff screened women at prenatal clinics between December, 2012 and June, 2015 in the catchment area of the three clinical sites to identify eligible women who continued to smoke cigarettes.|To exclude highly non-compliant subjects, consented patients entered a medication compliance trial of 14 ± 7 days. Placebo tablets were given to participants and they were excluded if they failed to return for a post compliance visit within 14 ± 7 days of the screening visit or if they took < 75% of the required tablets.
731022|NCT01723514|This study enrolled healthy participants (Part A) and participants with onset of migraines before the age of 50 years, with or without aura for at least 6 months and 3 migraine attacks per month in the last 3 months (Part B). The study was conducted at a single center in Belgium.|Healthy participants were randomized to 1 of 4 cohorts and migraine patients were randomized to 1 of 2 cohorts. Within each cohort participants were assigned to erenumab or placebo in a 3:1 ratio.
731023|NCT01723397||
731024|NCT01723384||
731025|NCT01723254||
731026|NCT01723228||
731027|NCT01723163|Participants who did not complete a follow-up were not prohibited from participating in the remaining study follow-up periods.|
731028|NCT01723072||
731029|NCT01722994||
731030|NCT01722929||
731031|NCT01722877|29 patients with FP ISR in 32 limbs were treated at 2 medical centers by 2 operators from October 2012 to August 2014. Patients were eligible only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5, and at least one patent runoff vessel.|Patients were excluded if they were not able to give informed consent, had a creatinine level >2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure. After consenting, patient were excluded if had denovo disease or no in-stent restenosis in the target vessel.
731032|NCT01722734|Subjects were recruited at all private and public facilities distributing Artemisinin-combination Therapies (ACTs).|Only subjects from the Tamale area with cell phones were included.
731033|NCT01722669||
731034|NCT01722643||
731035|NCT01722552|We recruited subjects from December 2012-April 2013. They were recruited at the Guangxi Provincial ART clinic in Nanning, China. Patients were eligible if they were receiving or initiating antiretroviral therapy (ART), aged 18 years or above, deemed at risk for poor adherence by clinic staff or patients themselves, and owned a mobile phone.|After enrollment, each subject was given a Wisepill electronic adherence monitoring container for use with his/her ART medications. Subjects selected one or more ART medications to be monitored within the device. All subjects underwent baseline adherence monitoring using Wisepill for 3 months before randomization.
731036|NCT01722487||
731037|NCT01722435||
731038|NCT01722331|The tables below present the Participant Flow for the Base Study only (Weeks 0 to 64: Part 1 for 12 weeks, Part 2 for 16 weeks, and Part 3 for 36 weeks).|
731039|NCT01722318||The Enrollment number in the Protocol Section was changed from 350 to 428 participants to reflect the actual enrollment number.
731040|NCT01722292||Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. Phase 1b study completer was defined as completion of the dose-limiting toxicity (DLT) period (1 cycle- 21 days cycle for LY2940680 in combination with carboplatin and etoposide.
731041|NCT01722266||
731042|NCT01722162|The study opened to patient enrollment on 04/26/2013 and closed to patient enrollment on 07/15/2015.|
731043|NCT01722097||
731044|NCT01722071||
731045|NCT01722045|The study was conducted at 43 sites in the US from 14Nov2012 to 03Sep2015. The target study population consisted of men and women 50 years of age and older with neovascular AMD who met all study eligibility criteria. A total of 288 patients were screened, of whom 154 patients were enrolled and treated. A total of 126 patients completed week 100.|
731046|NCT01721967||
731047|NCT01721954|Between 01May2013&24Dec2014,209 patients were screened&randomised from 87centres in Australia, Belgium,France, Germany, Israel, Italy, Korea, New Zealand, Portugal, Singapore, Spain,Taiwan &the US. 209 patients randomized in the Intent to treat (ITT) population. 5 patients who did not receive study medication were not included in safety population.|
731048|NCT01721837|Reasons for exclusion from analysis: 25 patients were documented as having severe renal impairment (RI), 1643 patients were acc. to documentation either not renally impaired or degree of RI was unknown or missing. Acc. to documentation 120 patients had valvular atrial fibrillation (AF), in 922 patients the origin of AF was unknown or missing.|4340 patients were enrolled in the study, 2220 patients had no documented mild or moderate renal impairment or no documented non valvular atrial fibrillation. Therefore, 2120 patients remained for analysis.
731049|NCT01721772||Of 583 participants enrolled, 418 were randomized (210 to nivolumab, 208 to dacarbazine) and 411 received treatment (206 with nivolumab, 205 with dacarbazine).
731050|NCT01721759||A total of 140 patients were enrolled, and 117 received treatment. Of those 23 patients who were enrolled but did not receive study drug, 20 were eliminated because they no longer met study criteria, 2 died, and 1 was lost to follow-up.
731051|NCT01721746|631 enrolled. 405 randomized. Reasons not randomized: 1 adverse event, 17 withdrew consent, 3 deaths, 1 lost to follow-up, 1 poor/non compliance, 200 no longer met study criteria, 3 unspecified. 370 treated. Reasons not treated: 13 request to discontinue study treatment, 17 withdrew consent, 1 poor/non compliance, 4 no longer met study criteria.|
731052|NCT01721681|Two subjects completed less than 26 weeks in the study. The subjects were re-enrolled and data from their first treatment cycle was excluded from the per-protocol analysis. 9 unique subjects were enrolled event though there were 11 treatment cycles.|
731053|NCT01721603||
731054|NCT01721564||
731055|NCT01721486|Participants were enrolled over a period of 23 months in the pre-operative setting of an out-patient surgical unit.|
731056|NCT01721473||
731057|NCT01721460||
731058|NCT01721447||
731059|NCT01721408||Of the total of 470 participants randomized, 235 were randomized to each treatment group. Seven participants (4 in tigecycline group and 3 in imipenem/cilastatin group) did not receive study treatment. One participant was randomized to imipenem/cilastatin group but received tigecycline and was reported and analyzed under the tigecycline group.
731060|NCT01721369||
731061|NCT01721330||
731062|NCT01721317|This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study comparing ezogabine/retigabine immediate release (IR) with placebo, as adjunctive treatment in adults with partial-onset seizures. The study was prematurely discontinued after randomizing only 6 of the planned 208 participants.|The study consisted of a 2-week (or less) Screening Phase, an 8-week Baseline Phase, a 2-week Titration Phase, an 8-week Dose-Optimization Phase, an 8-week Maintenance Phase, and a 3-week Taper Phase.
731063|NCT01721226||
731064|NCT01721200|Subjects were RA patients currently being treated by one of six rheumatologists practicing in the Geisinger Rheumatology Department in Danville, Pennsylvania who were at least 18 years of age, able to speak and read English & had active disease warranting initiation, or change, of a biologic therapy as determined by their treating rheumatologist.|Subjects excluded if hearing or visually impaired; scheduled for surgery;current infection; cancer past five years (except non-melanoma),lymphoma, leukemia,melanoma;chronic inflammatory disease (+ RA) immunosuppressive RX; chronic liver disease, hepatitis C or B;HIV +; TB+x-ray lesions of inactive TB & no chemoprophylactic therapy..
731065|NCT01721161||
731066|NCT01721109|Participants were enrolled at study sites in the United States, South Africa, and Thailand. The first participant was screened on 06 December 2012. The last study visit occurred on 29 January 2018.|56 participants were screened.
731067|NCT01721096|A total of 536 patients (213 in the Core Size (CS) arm and 323 in the Long Length (LL) arm) were recruited from the 25 sites between October 11, 2013 and June 30, 2013. All the patients except those terminated the surveillance have completed their follow-up at the end of the study.|To date, out of 536 patients, 524 (320 in LL arm and 204 in CS arm) have terminated the surveillance before completing their follow-ups
731068|NCT01721070||
731069|NCT01721057||"Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week 16.
~Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline."
731070|NCT01721044||Participants who did not adequately respond (nonresponders) to study drug were eligible for rescue treatment with baricitinib 4 mg beginning at Week 16. Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline.
731071|NCT01720797||
731072|NCT01720667||280 were enrolled to EEG monitoring and of these 106 were randomized to treatment as neonatal seizures were thought to have occurred. 174 excluded as they did not have electrographic seizures; from 6 participants only verbal not written consent obtained.
731073|NCT01720602||
731074|NCT01720524|This study is planned to be conducted in two parts Part A (double-blind phase) and Part B (long-term, non-intervention phase). Currently reported final results are only for Part A, at primary completion date. Part B (ongoing) results shall be provided at the time of study completion date.|Neonates with persistent pulmonary hypertension of the newborn (PPHN) or hypoxic respiratory failure (HRF) and at risk of PPHN who were receiving inhaled nitric oxide (iNO) treatment were evaluated in this study.
731075|NCT01720446|The trial was conducted at 229 sites in 20 countries. Country (sites): Algeria (4), Argentina (7), Australia (8), Brazil (8), Bulgaria (5), Canada (13), Denmark (5), Germany (7), Israel (6), Italy (6), Malaysia (6), Mexico (9), Poland (5), Russia (11), Spain (6), Taiwan (4), Thailand (5), Turkey (10), United Kingdom (8) and United States (96).|Subjects could be anti-glycaemic drug naïve, or treated with 1 or 2 oral anti diabetic drugs (OADs), or treated with human NPH insulin or long-acting insulin analogue or pre-mixed insulin, alone or in combination with 1 or 2 OAD(s).
731076|NCT01720316||
731077|NCT01720277|"Cluster--We included nursing homes (NHs) within 50 miles of a CDC surveillance. We identified and contacted individual facilities and organizations. Each recruited NH completed a site feasibility form and was notified of its eligibility based on the exclusion criteria.
~Subject--Eligible nursing home residents in each participating facility."|
731078|NCT01720264|The study was stopped at 15 patients due to poor accrual. One patient subsequently found not to have met eligibility because she commenced treatment one day earlier than the prescribed 35-day interval from previous therapy is included in the analysis.|
731079|NCT01720251||
731080|NCT01720225|Recruitment Period: November 2012 to February 2016|
731081|NCT01720173|The study was activated on 11/5/2012 and closed to accrual on 10/2/2013.|
731082|NCT01720069||197 subjects were randomised and 196 received at least one dose of study drug; 1 subject was randomised but not treated.
731083|NCT01720043||
731084|NCT01719900||
731085|NCT01719861|10 participants total were to be enrolled at Stanford Medical Center between December 2012 - December 2013|
731086|NCT01719783||
731087|NCT01719757|Safety set: 359 ITT set: 304|
731088|NCT01719744||
731089|NCT01719653||
731090|NCT01719367||
731091|NCT01719224|Women during the first 48 h after delivery were included. Patients with a history of preexisting pulmonary and cardiac diseases or neck and chest tumors, as well as patients with a history of irradiation to the neck and/or chest or congenital airway deformities were not included in the study|55 patients enrolled in the study and all of them successfully completed acoustic pharyngometry during wakefulness. 36 of 55 participants were randomized to receive one of the two sleeping positions first. Of those not randomized, 19 declined to participate in the overnight PSG recording.
731092|NCT01719172|Subjects who were scheduled for non-emergent, soft tissue procedures performed via an open approach were assessed for potential study eligibility via a screening/baseline assessment performed within 30 days of their scheduled procedure.|Subjects who met the pre-operative eligibility criteria were considered for study participation. During the surgical procedures, subjects who met the intra-operative eligibility criteria were enrolled into the study. Subjects who did not meet all criteria were considered screen failures and not enrolled.
731093|NCT01719003|With the first global protocol amendment (13-Dec-2012), the HbA1c inclusion criterion changed and further enrolment in the open label (OL) group was stopped, but the patients already entered in the OL group could continue until the scheduled end of the study.|Patients with an (Glycosylated Haemoglobin) HbA1c >10.0% at screening and meeting all other inclusion criteria were initially directly included in an OL treatment group
731094|NCT01718691||
752176|NCT00550589||
757933|NCT00186056||
731095|NCT01718535|Recruitment of study participants was performed without knowledge of participant genotypes by enrolling associates of operators and associates of Spartan Bioscience and Mount Sinai Services.|
731096|NCT01718522||
731097|NCT01718509||
731098|NCT01718483|Participants were recruited between 12-Nov-2012 and 19-June-2013 and locations included medical clinics & research centers.|
731099|NCT01718444||The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.
731100|NCT01718353|The study was conducted at 19 centers in Canada and United States. A total of 81 participants were screened between 20 March 2013 and 29 May 2014, of which, 63 participants were randomized and 61 were treated. A total of 18 participants were screen failure mainly due to exclusion criteria met and inclusion criteria not met.|Participants were randomized by Interactive Voice Response System (IVRS) in 2:1 ratio (Treatment A : Treatment B) to receive either Treatment A (Docetaxel + Prednisone) or Treatment B (Cabazitaxel + Prednisone).
731101|NCT01718028|Participants were recruited from 1 study center located in Argentina.|Of the 51 enrolled, 2 participants withdrew their consent prior to receiving treatment and were exited from the study. This reporting group includes all participants who received treatment.
731102|NCT01717989|From 16 June 2010 through 02 July 2012, 2248 participants were enrolled in the study. A total of 51 small dialysis organization facilities enrolled in the study, of these, 45 (88.2%) facilities reported completing the study, 5 (9.8%) discontinued and 1 site was unaccounted for.|
731103|NCT01717976||514 participants were randomized and assigned to either DISPO ED or usual care. One participant (UC arm) was found to be ineligible post-randomization and thus not included in analyses.
731104|NCT01717898||
731105|NCT01717872||
731106|NCT01717859|Patients were recruited through printed and internet advertisements, direct recruitment of study participants, referrals, review of medical records to identify potential participants, and through IRB approved screening protocol and IRB approved study. Patients were recruited starting on 9/24/14. The recruitment continued through November of 2016.|"16 did not pass inclusion criteria, these patients were not able to be assigned to a study arm: 8 had PDUS<10 4 lab values outside limits
~pregnant
~changed their mind
~1 was taking prednisone.
~Also:
~4 other patients were assigned to the study arm but were deleted from the study due to the considerations mentioned in the protocol"
731107|NCT01717768|130 subjects were recruited at 1 center in the US from October 2012 to May 2014. The study was designed with 4 parts, including 9 different dosages of the investigational drug.|
731108|NCT01717742||
731109|NCT01717638|Subjects were enrolled from 4 centers from the UK, 4 centers from Italy, 4 centers from Spain, 19 centers from Czech Republic.|All subjects were included in the trial.
731110|NCT01717521|After institutional review board approval, this observational pilot study was conducted at the University of Washington Medical Center (UWMC). Twenty women, 18 years of age or older, of American Society of Anesthesiology Physical Status I-III scheduled for an abdominal hysterectomy under sevoflurane anesthesia were recruited.|
731111|NCT01717482||
731112|NCT01717456|Home Health Care (HHC) provided lists to the investigators of new patients who were screened by HHC using the OASIS Questionnaire. Research assistants identified eligible patients based on the OASIS questions and telephoned them to obtain verbal consent and to schedule a baseline assessment visit. Written consent was obtained at the baseline visit.|Baseline data collection and written consent was obtained at a home visit prior to referring the patient to HHC for randomization and initiation of treatment. Only 19/31 who gave consent to the research assistant were randomized. 3 others were judged ineligible by HHC, and 9 dropped out while awaiting treatment.
731113|NCT01717391||
731114|NCT01717326|Male/female participants with Hepatitis C Virus (HCV) genotype 1 (GT1) or GT3 who were either treatment-naïve (TN) or prior null responder (NR), cirrhotic (C) or noncirrhotic (NC), and monoinfected with HCV or coinfected with HCV and human immunodeficiency virus (HIV) were recruited based on entry requirements for Parts A, B, C, or D.|573 participants were randomized on study. 65 TN NC GT1 participants were randomized in Part A. Part B randomized 94 TN NC participants, 123 TN C participants, 130 NR participants (C and NC), and 59 TN HIV coinfected participants. Part C randomized 61 TN NC GT1b participants, and Part D randomized 41 TN NC GT3 participants.
731115|NCT01717313||The double-blind treatment period included a 24-week placebo-controlled (omarigliptin/omarigliptin-matching placebo) period (Phase A) and a 30-week active-controlled period with blinded metformin/metformin matching placebo (Phase B).
731116|NCT01717287||Film-coated tablets were administered to participants >=12 years old and to those 6 to <12 years old who weighed >=25 kg and could swallow pills. A weight-based dose of chewable tablets was administered to participants 6 to <12 years old who could not swallow pills or preferred the chewable formulation, and to participants 2 to <6 years old
731117|NCT01717209||
731118|NCT01717053||
731119|NCT01717040||
731120|NCT01717014||
731121|NCT01717001||
731122|NCT01716754|A total of 471 participants were randomized to one of the 14 treatment groups. Of these, 5 participants did not receive study treatment. Therefore, the full analysis set (FAS) and safety set included 466 participants.|The treatment arms for QGE031 and placebo were pooled into high dose QGE031 (240 mg q2w, 240 mg q4w, 180 mg q2w and 120 q2w), low dose QGE031 (36 mg q2w and 18 mg 2qw) and Placebo Total (all QGE031 placebo and Omalizumab placebo arms).
731123|NCT01716715|111 patients were enrolled from November 6, 2012 to May 5, 2014|
731124|NCT01716663||
731125|NCT01716585||
731126|NCT01716559|This is an observational study. A total of 160 participants were enrolled across 8 study centers in Hungary from 03 August 2010 to 28 March 2012.|
731127|NCT01716533|In total 57 subjects were enrolled, among which 11 subjects from one centre in the United States (University of Texas School of Public Health, Houston) who were excluded from final analysis due to GCP issues.|Two extra groups were identified in addition to the two groups foreseen in the protocol: Failure to antibiotic Group and Unclassified Group.
731279|NCT01707654|From July 2008 to May 2010, 9 patients who had a combination of soft tissue and digital nerve defects were included in the study. The type of location was medical clinic.|No patient was lost to follow-up
757934|NCT00186043||
731128|NCT01716520||Participants who met the eligibility criteria at screening (Visit 1) completed a 5- to 7-day run-in period prior to being randomized to 1 of 6 treatment sequences. The treatment phase was comprised of three 14-day treatment periods, each separated by a 10- to 14-day washout period, starting on Day 15.
731129|NCT01716468||
731130|NCT01716455||
731131|NCT01716234||A total of 160 participants were screened, 142 were randomized / enrolled, and 136 were treated. An arm planned for participants aged 3 months to <2 years to receive posaconazole 18 mg/kg/day TID was never initiated.
731132|NCT01716221||
731133|NCT01716169|Recruitment from EB Clinic patients, organization website|
731134|NCT01716156|A total of 26 treatment-naive non-cirrhotic adult participants with hepatitis C virus (HCV) genotype 1 (GT1) were recruited in Australia, Israel, and New Zealand.|Allocation of participants to the 2 arms was stratified according to HCV GT1a vs. GT1b infection. Participants in the 12-week arm with detectable HCV ribonucleic acid (RNA) at Treatment Week (TW) 4 received 12 additional weeks of study treatment and are displayed in a separate treatment arm.
731135|NCT01716117||
731136|NCT01716104||"Selection procedures were carried out after participant enrollment to determine whether the patient could participate in the study in accordance with the inclusion criteria.
~Of the 260 patients enrolled, 11 did not meet inclusion criteria after screening procedures, they were not randomized."
731137|NCT01716052|When the woman signs in at the breast imaging clinic desk (on the 5th floor of the Zeller Building at the CTRC), she will be asked if she would speak with the study nurse about this study.|
731138|NCT01716013||
731139|NCT01715948||
731140|NCT01715896||Overall, 215 participants were screened, of which 77 participants were considered as screen failures and 138 participants were randomized and completed in the study.
731141|NCT01715883||
731142|NCT01715857||
731143|NCT01715831||
731144|NCT01715805||1022 patients participated in an 8 week open label antidepression therapy (ADT) + single blind placebo lead-in period. 530 patients who did not respond were randomized to receive ADT or cariprazine + ADT in the double-blind period and non-responders continued ADT + Placebo.
731145|NCT01715415||
731146|NCT01715298||
731147|NCT01715285||1209 participants were enrolled and 1199 were randomized to treatment groups.10 participants from Russian site were excluded from the analysis due to noncompliance with International Conference on Harmonisation Good Clinical Practice guidelines at site. The remaining 1199 randomized participants comprised the intent-to-treat population.
731148|NCT01715233||6 subjects were screen failures.
731149|NCT01715207||The study was premature termination due to the stop of supporting medication from company.
731150|NCT01715129||A total of 139 subjects were screened and 13 subjects were screen failures.
731151|NCT01715064|Eligible patients were approached for participation by a research coordinator from June to October, 2010. 86 eligible participants were approached for participation and 19 agreed (22% participation rate). Seventeen participants responded to the study poster. The 36 participants were randomly assigned to the exercise (n=18) or control (n=18) group.|
731152|NCT01714947|Participants took part in the study at 1 investigative site in the United States from 24 January 2013 to 14 June 2013.|Participants with a diagnosis of advanced solid tumors or lymphomas received [^14C]-alisertib 35 mg oral solution single dose in Part A and alisertib 50 mg for 7 days in 21-day cycles in Part B.
731153|NCT01714921|504 patients were enrolled at 29 German sites between 09-Jun-2010 and 22-Oct-2012|
731154|NCT01714817||Overall, 695 participants were enrolled; 406 randomized; and 405 received treatment. 289 participants were screen failures and never treated with study medication; 233 were due to no longer meeting study criteria; 19 withdrew consent; 4 due to Adverse Events; 1 due to death; 1 due to poor/non-compliance; 1 was lost to follow up; and 30 were other.
731155|NCT01714804||
731156|NCT01714726||Out of 174 screened subjects, 53 were considered screen failures. A total of 121 subjects were randomized, of which 2 did not receive study drug. Those 2 subjects were not included in the mITT population; therefore, those subjects are not counted in the participant flow.
731157|NCT01714687||
731158|NCT01714635||
731159|NCT01714609||
731160|NCT01714544||
731161|NCT01714505||
731162|NCT01714492|hospital, medical clinic|
731163|NCT01714336||
731164|NCT01714323|Recruitment of eligible daily smokers admitted to 3 hospitals (Massachusetts General Hospital, Boston, MA; University of Pittsburgh Medical Center, Pittsburgh, PA; and North Shore Medical Center, Salem, MA) occurred during the period 12/3/2012 - 7/18/2014|1359 patients were enrolled in the study and randomized to Sustained Care (n=681) or Standard Care (n=678). Two patients, 1 in each group, were excluded post-randomization but before hospital discharge (when intervention began) because they were not eligible. ITT analysis was conducted on 1357 patients (Standard Care n=677, Sustained Care n=680).
731165|NCT01714310||At completion of open lisdexamfetamine, participants who achieved Clinical Global Impression Severity (CGI-S) SMD score < 4 were deemed sufficiently improved, and not randomized to adjunctive treatment. N=4 participants were sufficiently improved and completed study participation at study week 4, prior to randomization
731166|NCT01714232||
731167|NCT01714063||
731168|NCT01714024||
731169|NCT01713998|"Forty-seven subjects were enrolled, randomized, and treated. The first subject treated on 10/4/2011; the last subject treated on 2/13/12; the last follow-up was 10/11/12.
~Enrolled subjects were randomized to one of three study groups (Group A, B, or C)."|
731170|NCT01713946|355 patients were planned to be enrolled and a total of 366 patients were randomized: 117 to the everolimus targeted low-trough arm (LT), 130 to the everolimus targeted high-trough (HT) arm, and 119 to treatment with placebo.|
731171|NCT01713933|Enrollment opened 6/29/2011 and the last subject was treated 11/28/2011. Subjects were recruited from the site's patient database.|
731172|NCT01713868||
731173|NCT01713686||
731174|NCT01713660|Subjects were recruited from private medical practices from October to December 2012|No preassignment details
731175|NCT01713621|Patients were recruited and followed up over 28 days in four clinics in Thailand from April 2013 to April 2015.|
731177|NCT01713582|80 participants were enrolled in the acute leukemia (AL) cohort and 78 were treated. 61 participants were enrolled in the other hematological malignancies (OHM) cohort and 60 were treated.|The study consisted of a dose escalation phase in participants with AL and OHM followed by and expansion phase in 3 cohorts: de novo acute myelocytic leukemia (AML), myelodysplastic syndrome (MDS) AML, and diffuse large B-cell lymphoma (DLBCL).
731178|NCT01713530|The trial was conducted in 5 countries (48 sites): Algeria (4), Austria (6), France (8), Norway (6) and United States (24).|
731179|NCT01713400|54 participants (potential donors and recipients) were enrolled at Moffitt Cancer Center from 3/15/2013 through 5/22/2014.|30 eligible recipients were randomly assigned 1:1 (Ustekinumab n=15, Placebo n=15) with stratification for donor type. Results Data pertains to recipients only.
731180|NCT01713348||A total of 105 subjects consented and enrolled into the study. Eighteen of these withdrew before randomisation or failed screening. Eighty-seven (87) subjects were randomised and 79 completed the study.
731181|NCT01713283|Participants were enrolled at one study site in the United States. The first participant was screened on 01 October 2012. The last participant observation occurred on 12 February 2014.|76 participants were screened.
731182|NCT01713036|First/last subject (informed consent): Nov 2012/Apr 2013. Clinical data cutoff: Jun 2013, Study completion date: Jul 2014 (Part B)|A total of 11 male subjects with locally advanced or metastatic solid cancer were screened for this trial. Six (6) subjects were enrolled and received the trial medication. Of them, 5 subjects completed Part A and further continued in Part B and completed the study.
731183|NCT01712984|The study participants were enrolled from 22 October 2012 to 28 May 2013 at 38 clinic sites in the United States.|A total of 3360 participants who met all of the inclusion and none of the exclusion criteria were randomized, 3355 received one of the trial vaccines and their data are presented in this report.
731184|NCT01712854|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.|
731185|NCT01712776|emergency department patients|
731186|NCT01712711||
731187|NCT01712685||
731188|NCT01712516|Participants were randomized to each treatment arm in a 1:1:1:1 ratio.|One thousand one participants were randomized. (One participant was randomized twice, took study drug twice and was counted twice in the randomized and safety sets). In the safety set, participants were analyzed according to the treatment received.
731189|NCT01712490|Participants took part in the study at 218 investigative sites in Asia Pacific, Europe, Latin America, and North America from 09 November 2012 to the primary completion date of 20 April 2017.|Participants with histologically confirmed diagnosis of advanced classical hodgkin lymphoma (cHL) were enrolled to receive: brentuximab vedotin 1.2 mg/kg plus doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (A+AVD) or doxorubicin 25 mg/m^2, bleomycin 10 units/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (ABVD).
731190|NCT01712438||
731191|NCT01712399|A total of 409 participants consented and 397 participants received mavrilimumab in this study.|A total of 442 participants who received at least one dose of mavrilimumab provided a pooled analysis of safety and efficacy data from this open-label extension study (CD-IA-CAM-3001-1109) together with the qualifying studies (CD IA CAM 3001 1071 and CD IA CAM 3001 1107).
731192|NCT01712360||
731193|NCT01712334|99 patients were enrolled. 96 unique patients entered the run-in period including 3 patients who entered the run-in period twice.|Patients received dornase alfa (Pulmozyme®) by LC Plus nebulizer in the 2-week run-in period prior to randomization. A total of 86 unique patients were randomized in the study in 87 randomization events. Of the randomized patients, 85 patients completed the study in two treatment sequences.
731194|NCT01712256||
731195|NCT01712230||
731196|NCT01712204|Overall, 82 patients from 8 clinical centers participated in the study between 28 January 2013 to 04 September 2013.|Participants were assessed at an initial screening visit within 2 weeks before the baseline visit.
731197|NCT01712178||
731198|NCT01712074|Before entering in the 12-week treatment period, participants were required to enter a 4-week placebo run-in period. 195 participants started the placebo run-in period, of which 186 were eligible for the treatment period. Among the 186 enrolled participants, 185 were treated with the double-blind study treatment, 1 was enrolled but not treated.|This study was a multicenter Phase 2a, randomized, placebo controlled, safety and efficacy study of 18 weeks in duration in participants with mild-to-moderate Alzheimer's disease (AD) who were stable on treatment with 5 or 10 mg of donepezil and who had existing neuropsychiatric symptoms.
731199|NCT01712061||The primary entry criterion for participants was based on presence of macroalbuminuria (urine albumin to creatinine ratio [UACR] greater than or equal to (>=)300 milligrams per gram (mg/g).
731200|NCT01712009|This study was conducted at 83 centers in the United States. The first participant enrolled on 01 November 2012 and the last participant enrolled on 20 November 2014.|Participants were randomized in a 1:1:1 ratio to receive no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine. Randomization was stratified by age group (< 65 years vs ≥ 65 years) and planned chemotherapy type (taxane vs non-taxane). Participants remained on study for the first 4 chemotherapy cycles.
731201|NCT01711983||
731202|NCT01711918||
731203|NCT01711866|"This multicenter study started to enroll subjects in September 2012 in order to enroll 87 subjects in 5 countries.
~Participant Flow refers to the Safety Set (SS). SS consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period."|
731204|NCT01711853||
731205|NCT01711736|Primed subjects: Received 2 doses of seasonal influenza vaccine separated by at least one month during the last season or had received at least 1 dose prior to last season. Unprimed subjects: Did not receive any seasonal influenza vaccine in the past or received only 1 dose for the first time in the last influenza season.|5 subjects enrolled in the study were allocated subject numbers but the study vaccine dose was not administered.
731206|NCT01711645|Postpartum participants were recruited within 1-4 days of full-term delivery in the Nashville area between 26Oct2012 and 03Sep2013.|
732520|NCT01629823||209 individuals were enrolled in the study. 15 of those participants were excluded from data analysis due to significant data irregularities at one clinical site
731207|NCT01711619|The first subject enrolled in the study on January 11, 2013. The last subject was enrolled on January 15, 2016 and all subject visits were stopped as of the study termination date of February 12, 2016.|Patients were considered enrolled in the study upon signing an Informed Consent Form. Enrolled subjects then completed additional assessments and were provided a diary to record ther back and leg pain intensity. Upon completion of the at-home diary, eligibility was reassessed based on pain scores. Eligible subjects were then randomized.
731208|NCT01711541||The study originally opened at Dose Level 0 with a treatment of Docetaxel, cisplatin and flouricil (TPF) in combination with ABT-888 (veliparib). With a concern for the feasibility of this regimen in other reported studies, this study was suspended and re-opened with a treatment of Carboplatin and Paclitaxel in combination with ABT-888.
731209|NCT01711424||Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. There was no investigational drug administered in this study.
731210|NCT01711372|Invited for participation consecutive patients referred to a child psychiatrist. From this cohort of patients, two groups formed. Patients who had received ADHD diagnosed and those who had not.|113 patients were screened for ADHD vs no ADHD. Those with ADHD were asked to not take stimulant medications for at least 3 days prior to participating. Company no longer exists and no longer has access to data collected. Only information in published study results available.
731211|NCT01711359||"Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week 24.
~Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count."
731212|NCT01711294||
731213|NCT01711216||A total of 1000 patients were screened. 1 Patient failed screening and 999 were enrolled into the program.
731214|NCT01711177||
731215|NCT01710891||
731216|NCT01710839||
731217|NCT01710800|All eligible patients with suspected GERD will be referred to the manometry and reflux lab testing for potential recruitment into the study|Prior to undergoing 24 hour pH with impedance, all participants will receive either one week of esomeprazole or one week of placebo.
731218|NCT01710787||
731219|NCT01710709|This open-label, single-arm, uncontrolled trial evaluated aripiprazole intramuscular (IM) depot as maintenance treatment for participants with bipolar I disorder. Enrolled participants included those who had completed Trial 31-08-250 (NCT01567527) as well as de novo participants who had not participated in Trial 31-08-250.|Screening period was from Day -42 to Day -2. Participants from the Trial 31-08-250 entered directly into the IM Depot Maintenance Phase of Trial 31-08-252. For de novo participants, this trial consisted of Phases A-C (Conversion Phase, Oral Stabilization Phase, and IM Depot Maintenance Phase).
731220|NCT01710657|A total of 676 subjects with uncontrolled partial-onset seizures (of the 676 subjects, the number of Chinese subjects and Japanese subjects was planned to be 507 and 169, respectively) was planned to be screened and 540 subjects were planned to be enrolled in all regions of Japan and China.|Overall, 692 subjects were screened and 548 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 547 subjects were included in the Safety Set.
731221|NCT01710527|The study was conducted on 32 adult healthy male participants, aged between 18 and 45 years, at a single site of India from 9 May 2012 to 18 May 2012. During each study period participants received test (treatment T-Metformin tablet) and reference (treatment R-Glucophage® tablet) products.|A total of 32 participants were randomized in the period I to receive test (treatment T-Metformin 500 milligram [mg] tablet) or reference (treatment R-Glucophage 500 mg tablet).
731222|NCT01710514||
731223|NCT01710501||Of 136 screened participants, 87 were randomized to treatment at 19 sites worldwide.
731224|NCT01710358||"Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week16. Participants not rescued at Week 16 may be rescued at the discretion of the investigator anytime thereafter.
~Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count."
731225|NCT01710345||
731226|NCT01710332||
731227|NCT01710306||
731228|NCT01710254||
731229|NCT01710137||
731230|NCT01710046||
731231|NCT01710033||
731232|NCT01710020||
731233|NCT01709981||
731234|NCT01709903|Patients were randomized into 2 treatment arms of the study with an equal 1:1 randomization ratio: QVA149 and Flut/Salm|A total of 1189 patients were screened; 744 (62.6%) completed the screening phase while 445 (37.4%) patients discontinued prior to completion of the screening phase
731235|NCT01709864||
731236|NCT01709838|At least 117 patients were planned to be enrolled; 134 patients were enrolled.|At least 117 patients were planned to be enrolled; 134 patients were enrolled.
731237|NCT01709799|Participants in the VITAL study were all healthy elders aged 60 years or older. The VITAL participants were drawn from the independent living portion of the retirement community where the study was located as well as from the broader Gainesville community.|Exclusion criteria included Mini Mental Status Examination scores less than 25, a diagnosis of dementia or neurologic condition, unstable medical conditions, low hearing or vision, inability to engage in physical exercise, or already active (for more that 125 minutes per week at 75% their maximum target heart rate).
731238|NCT01709786||
731239|NCT01709708||
731240|NCT01709695||
731241|NCT01709578|The study was conducted at 240 centers in 27 countries. A total of 1224 participants were screened between 29 October 2012 and 7 August 2014, of whom 546 participants were randomized and 678 were screen failures. Screen failures were mainly due to failure to meet inclusion criteria.|Participants were randomized 1:1:1 (placebo q2w : sarilumab 150 mg q2w : sarilumab 200 mg q2w) via a centralized randomization system using an interactive voice response system stratified by region and number of previous anti- tumor necrosis factor (TNF) therapy (1 versus >1).
731280|NCT01707472|Participants were enrolled at 1 study site in the United States. The first participant was screened on 04 October 2012. The last study visit occurred on 17 October 2014.|37 participants were screened.
731281|NCT01707381||
732521|NCT01629797||
754274|NCT00437268||Participant flow reports those participants who discontinued from study drug.
731242|NCT01709513|The study was conducted at 67 sites in 8 countries. Overall, 519 participants were screened between 28 September 2012 and 11 August 2013, 158 of whom were screen failures. Screen failures were mainly due to exclusion criteria met. After screening, 361 participants entered into a 4-week single blind placebo run-in period.|At the end of the single blind placebo run-in period, eligible participants were randomized to treatment arms centrally using a 2:2:1 (alirocumab:ezetimibe:atorvastatin) ratio. Randomization was stratified according to prior history of myocardial infarction or ischemic stroke. 314 participants were randomized.
731243|NCT01709500|The study was conducted at 26 sites in 4 countries. Overall, 322 participants were screened between 28 Nov 2012 and 26 Apr 2013, 73 of whom were screen failures.|Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, and intensity of statin treatment. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 2:1 (alirocumab: placebo) ratio after confirmation of selection criteria.
731244|NCT01709474||
731245|NCT01709422|Patients who were schedule for endoscopic retrograde cholangiopancreatography in NKC Institute ,Prince of Songkla University during January 2010-December 2011|Patients were excluded from the final analysis if the procedure was terminated due to technical reasons prior to attempted cannulation.
731246|NCT01709409|Three university-affiliated tertiary NICUs recruited patients between March 2013 and December 2015. 560 patients were screening for eligibility.|One patient in the Curosurf group was found to have an exclusion criteria after randomization and was excluded (he did not receive the assigned treatment).
731247|NCT01709383|Inclusionary criteria were as follows: over 18; aphasia due to left hemisphere stroke; no other significant brain damage, neurological, or psychiatric disease; no skull defects near electrode sites; no implanted devices or ferrous metal in the body; not pregnant; comprehension sufficient to perform study tasks|Before randomization, potential subjects were tested on the Western Aphasia Battery -Revised (WAB-R) to determine a baseline score and to rule out severe comprehension deficits.
731248|NCT01709331||Twenty-three participants entered the 16-week pretreatment phase with hCG. At the end of the pretreatment phase, 18 participants were enrolled in the 52-week combined treatment phase.
731249|NCT01709318|The study enrolled healthy female participants aged 18 to 35 years, with cycles between 24 to 35 days in length.|Of the 757 participants who were screened for inclusion in the trial, 666 participants were randomized, and 660 participants were treated.
731250|NCT01709305|Adult Chinese participants (≥18 and ≤75 years of age) with a diagnosis of Type 2 Diabetes Mellitus (T2DM) and inadequate glycemic control were selected to participate in this study.|There were 2344 participants who achieved A1C<7% in Phase 1; they completed Phase 1 and did not enter Phase 2. Of the remaining 2589 participants, 377 participants did not meet randomization criteria to enter Phase 2.
731251|NCT01709227||
731252|NCT01709162||A total of 31 participants were enrolled. Of the 23 who were randomized, 22 received treatment .
731253|NCT01709149|Patients with familial or sporadic amyotrophic lateral sclerosis were enrolled at 73 sites in Canada, France, Germany, Ireland, Netherlands, Spain, the United Kingdom, and the United States. The first patient was screened on 23 October 2012 and the last subject completed follow-up on 21 March 2014.|A total of 711 patients were enrolled in the study and began treatment with open-label tirasemtiv during the 7-day lead-in phase of the study. Patients who completed this phase were randomized (1:1) to receive either placebo (N=295) or tirasemtiv (N=301) in the double-blind treatment period.
731254|NCT01709136||
731255|NCT01709110||
731256|NCT01709084||
731257|NCT01709032||
731258|NCT01708967||
731259|NCT01708954|This study was activated on February 7, 2013 and closed to accrual on July 1, 2014 with final accrual of 125 patients. Among these, a total of 20 patients registered to Step 2.|
731260|NCT01708941|Participants were recruited from ECOG-ACRIN member institutions between 1/18/2013 and 11/30/2015.|
731261|NCT01708915||
731262|NCT01708902||After 2-weeks placebo run-in in the main group, 730 of 733 randomised patients were treated in a double-blind fashion for 24 weeks. In the additional parallel group (APG), all of 143 randomised patients with HbA1c >=11% were treated for 24 weeks (the first 12 weeks were double-blind). There was a 1-week follow-up period after treatment.
731263|NCT01708629||
731264|NCT01708603||
731265|NCT01708590||Total number should be calculated from the induction phase at 661 subjects starting the study. At week 12 if subjects achieved sPGA success (clear[0] or almost clear[1]) they were not continued in the study withdrawal phase to receive drug. Those not achieving success were re-randomized for treatment continuation.
731266|NCT01708525||
731267|NCT01708317|We monitored overall testing in the ED from Jan 2010 - March 2012, but only actively enrolled patients from April 18, 2011 - Dec 20, 2011. All ACASI participants were patients in the St. Louis Children's Hospital ER.|There was an education lead in before introducing the ACASI, to see if education alone would increase the amount of patients receiving gonorrhea/chlamydia testing. The education started in Jan, 2011 and continued the remainder of the study period.
731268|NCT01708291||3 participants were not included in the study due to fighting.
731269|NCT01708278||
731270|NCT01708213||
731271|NCT01708187||
731272|NCT01708174||Analyses were performed by treatment and by age group.
731273|NCT01708161||Patients with selected advanced solid tumors who had relapsed or progressed on standard therapy were treated in BYL719X2105J study with a combination of alpelisib and ganitumab. Phase I of the trial was by dose combination of the treatment. Phase II was by patients.
731274|NCT01708122||Seventy-one patients agreed to participate in the study and signed informed consent. Nine patients declined to proceed. Seven did not pass pre-anesthesia screening due to pre-existing medical conditions. Cystoscopic procedures were deemed no longer indicated for two patients. Ultimately, 53 patients were randomized and completed the study.
731275|NCT01708057|A total of 14 subjects were enrolled. Of these, 3 subjects were randomized to receive a treatment sequence consisting of 6 different treatments in random order. The study was terminated prematurely, hence only one period out of six planned was performed.|
731276|NCT01707992||The study was conducted at 215 sites in 29 countries.
731277|NCT01707693||
731278|NCT01707667||
731354|NCT01703169||
731282|NCT01707368|"The study was conducted in Germany between 8th September 2011 (retrospective data) and 15th May 2014. The planned observation period for each patient was about 12 months.
~The total planned sample size of this NIS was 1000 (analysable 750) patients."|
731283|NCT01707290||The study consisted of 2 arms: Ivacaftor arm and Observational arm. The Ivacaftor arm enrolled subjects from Study VX11-770-110 (NCT01614457), Study VX12-770-111 (NCT01614470) and Study VX12-770-113 (NCT01685801). The Observational arm enrolled subjects from Study VX11-770-110 (NCT01614457) and Study VX12-770-111 (NCT01614470).
731284|NCT01707238|Number subjects enrolled per site ranged six to 25. Two sites were asked to enroll more than 20 subjects to fulfill required number of subjects. Approval from Ethics Committee sought before sites were invited to recruit additional subjects. Of the 100 enrolled, 13 were existing etafilcon A wearers, falling short of the 25% target.|"All participants randomized to receive all interventions and combined into one Arm/Group, Overall All Study Population for the participant flow."
731285|NCT01707225||
731286|NCT01707147|A regulatory requirement prospective, non-interventional, open-label, multi-centre national study to monitor the safety and effectiveness of Trajenta (Linagliptin, 5 milligram (mg), once daily) in Korean patients with type 2 diabetes mellitus|All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
731287|NCT01707095||
731288|NCT01707043||
731289|NCT01707030||
731290|NCT01707004|Recruitment of high risk BMT patients with active disease at time of transplant or very high risk to relapse post-transplant.|
731291|NCT01706978||A number of participants who consented to be part of this study were withdrawn or excluded, prior to randomization due to study procedures not being able to be arranged pre-operatively for various reasons. A large number of participants were crossed over into another parallel study being run at The Ottawa Hospital.
731292|NCT01706965||
731293|NCT01706952||
731294|NCT01706926||A total of 420 participants were screened out of which 326 participants were randomized and received investigational product in the study.
731295|NCT01706822||
731296|NCT01706770|52 subjects evaluated. Of these 52 subjects, 2 found ineligible and not randomized resulting in 50 subjects randomized, 33 test, 17 control. Of 50 subjects randomized, 2 discontinued and not included in results data, 31 test, 17 control, 1 lost to follow-up, 1 Sponsor/IRB decision due to pregnancy at one month visit.|
731297|NCT01706666||
731298|NCT01706588||
731299|NCT01706575||A total of 76 participants started the study and were included in lead-in period. Out of 76 participants, 70 received study drug.
731300|NCT01706549|January 2012-December 2013. Patients recruited from previous studies. Clinical evaluation at the Hospital on the basis of volunteering.|
731301|NCT01706536||"Out of 302 subjects, 294 completed the run-in period. 12 out of 294 subjects completed the run-in period, but did not enter the double-blind period. Total of 282 subjects entered the double-blind period.
~Specific details are outlined in the table below."
731302|NCT01706497||In this prospective observational cohort study, we had aimed at including 300 patients with continuous NIRS monitoring in place. In only 177 patients we could retrieve a continuous near-infrared spectroscopy monitoring signal of sufficient quality for inclusion in the study.
731303|NCT01706458||
731304|NCT01706328|Only those participants that started the Double-blind Treatment Period were considered enrolled.|At Visit 1, participants entered a 2-week, single-blind (placebo) Run-in Period to obtain Baseline assessments of salbutamol use and to evaluate adherence with study treatment and procedures, diary card completion, and assessment of disease stability. At Visit 2, participants were randomized to a 12-week, double-blind Treatment Period.
731305|NCT01706263|Male or female participants aged from 18 to 29 years with mild facial acne vulgaris were enrolled in this study. The study was conducted at three different study centers. Study period was 8 Weeks (56 days) and study conducted from 19 August 2009 to 01 December 2009.|
731306|NCT01706250|A total of 20 participants were enrolled to an evaluator-blinded, split-face study of acne, which was conducted at two centers in United States from 08 September 2009 to 25 January 2010.|Same 20 participants were used in the split face study for the 2 interventions namely MaxClarity and Proactiv carried out in a single period.
731307|NCT01706198|This was a multi-center, randomized, open label study to evaluate the effectiveness of fluticasone furoate (FF)/vilanterol (VI) Inhalation Powder (FF 100 micrograms [mcg]/VI 25 mcg or FF 200 mcg/VI 25 mcg) compared with usual asthma maintenance therapy in participants with asthma in a localized geographical region of United Kingdom.|A total of 4725 participants were screened of which 4233 participants were randomized to either initiate with FF/VI or continue their usual asthma maintenance therapy in a ratio of 1:1. The total duration of study was approximately 12 months (52 weeks).
731308|NCT01706159|The trial was conducted at 12 sites in 6 countries as follows: Bulgaria (4 sites), Denmark (1 site), Hungary (1 site), Poland (4 sites), Russian Federation (1 site) and Ukraine (1 site).|No pre-assignments were given for this trial.
731309|NCT01706146||
731310|NCT01706081||
731311|NCT01706003||
731312|NCT01705977|This was a global, multi-center, randomized, placebo-controlled double blind study that evaluated adverse events of special interest in adult participants with active, autoantibody-positive systemic lupus erythematosus (SLE) when treated with belimumab plus standard therapy versus participants who received placebo plus standard therapy.|4019 participants were randomized of which one participant was not entered into database and did not receive study treatment. 4003 participants who received at least one dose of study treatment contributed to the Intent-to-Treat (ITT) Population. Results presented are based on the primary study analysis of the Week 52 double-blind treatment period.
731313|NCT01705730||A total of 71 participants were enrolled in the study. Out of 71 participants, 68 received at least one dose of tocilizumab during the study and were included in the full analysis set.
731314|NCT01705717||
731315|NCT01705691||One patient randomly assigned to Arm 2 withdrew consent before receiving protocol therapy.
731355|NCT01703091||Study completion was defined as death due to any cause or disease progression.
731356|NCT01703065||
731357|NCT01703039||
731316|NCT01705652|Subjects were recruited from 7/20/2011 to 4/16/2013 from the ALM VA South Texas urology clinic.|Subjects were required to have a diagnosis of prostate cancer and treatment planned by surgery or radiation therapy.. Subjects were excluded if they were currently taking anticoagulation medications, or medications that are known to produce or are suspected of QT prolongation.
731317|NCT01705587||
731318|NCT01705574|Participants were enrolled at study sites in North America, Europe, Dominican Republic, Thailand, and Uganda. The first participant was screened on 24 October 2012. The last study visit occurred on 06 September 2018.|810 participants were screened.
731319|NCT01705509||
731320|NCT01705496||
731321|NCT01705288||
731322|NCT01705236|Subjects were screened at 10 study centers in Germany (9 centers) and Switzerland (1 center).|Subjects who passed the screening were enrolled in the trial.
731323|NCT01705145||
731324|NCT01705106||
731325|NCT01705080||
731326|NCT01704976||
731327|NCT01704846||
731328|NCT01704781||
731329|NCT01704755||In the 12-week treatment group, one participant withdrew from the study before receiving study drug.
731330|NCT01704651|The study took place at Mayo Clinic in Rochester, Minnesota from January 2013 to June 2015.|
731331|NCT01704599|All subjects were recruited at one of the Two Wayne State University Physician Group Dermatology clinics . Recruitment began Oct 2010 and lasted until 2012|There were 11 potential subjects analyzed of which 3 were not enrolled prior to study assignment. The 3 did not meet study criteria.
731332|NCT01704521|January 2013 through April 2014 at Digestive Diseases Research / University of Cincinnati|
731333|NCT01704495|6 months double-blind study with optional safety extension for up to 6 months, were subjects continued on the treatment they were randomized to. First subject enrolled 27 Nov 2012 Last subject last visit 27 Aug 2014 1146 subjects enrolled in tot of which 506 patients were not randomized since they did not fulfilled all the inclusion conditions.|"4 weeks run-in period on background therapy prior to randomization.
~The discrepancy in the number of enrolled patients compared to the protocol section (n=1147) is because of a patient was in error reported by a monitor as enrolled when the patient was in effect not enrolled."
731334|NCT01704456||
731335|NCT01704404||
731336|NCT01704287||This end of trial analysis is based on a trial closure database cutoff date of 31-Jan-2019.
731337|NCT01704261|Fifty-one sites received IEC/IRB approval and were shipped clinical supplies.|In total, 583 participants were screened and 276 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were not meeting the metformin and glimepiride dose requirements inclusion criterion or meeting exclusionary laboratory values.
731338|NCT01704196||
731339|NCT01704079|This multicenter study was conducted at 45 investigational sites within the US. Subjects were enrolled and treated from 04 February 2013 through 13 August 2014.|Subjects were stratified by CKD stage and were randomized in a 2:1 ratio to receive a daily 30 μg oral dose of CTAP101 capsules (or matching placebo) for 12 weeks at bedtime. Subjects presenting on a regimen of bone metabolism therapy were to discontinue their prior treatment for at least 28 days' washout (except for bisphosphonates).
731340|NCT01703988||
731341|NCT01703858||An open label, randomised, single dose, 3-way cross-over study to investigate relative bioavailability and food effect on different formulations of Boehringer-Ingelheim (BI) -113608 in healthy male subjects, followed by fixed sequence periods investigating influence of pantoprazole coadministration and food effect on pharmacokinetics of BI-113608.
731342|NCT01703845||This is a randomised, open-label, parallel group trial in which 3 weeks of randomised treatment are preceded by 2-week screening period and followed by 3-week follow-up period.
731343|NCT01703832|Recruitment was carried out in 2 outpatient clinics in Germany (Marburg and Essen).|All 65 healthy participants were enrolled and none were excluded prior to randomization.
731344|NCT01703819|Recruitment was carried out in 2 outpatient clinics in Germany (Marburg and Essen).|All 66 healthy participants were enrolled and none of them was excluded prior to randomization.
731345|NCT01703741|Subjects were recruited from 16 study centers in United States and 2 study centers in Canada.|Of the 172 subjects who completed study 000023 (NCT01665599), 145 subjects were enrolled into this extension study and continued to receive treatment (23 mg, 46 mg or 69 mg).
731346|NCT01703702||641 patients enrolled in the study. 21 patients withdrew before receiving a florbetapir (F18) PET scan. 620 patients received florbetapir and comprise the Safety Population; 2 patients did not have a valid PET scan. Therefore; 618 patients were randomized to the intervention or control arms and comprise the Efficacy Population.
731347|NCT01703663|Some subjects were discharged from the hospital between the first and second night and therefore dropped out.|
731348|NCT01703598||
731349|NCT01703507||
731350|NCT01703286||
731351|NCT01703260|Participants took part at 11 sites in the United States from 26 April 2013 to 30 September 2014.|Participants with a historical diagnosis of nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) activity score (NAS) of greater than or equal to (>=) 3 were enrolled in 1 of 3 treatment groups as follows: roflumilast + pioglitazone; roflumilast only; pioglitazone only.
731352|NCT01703221|Forty-eight sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. One hundred and seventeen participants were not randomized; the most common reason for participants not being randomized was screen failure.|In Phase A, participants were randomized to receive either omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.
731353|NCT01703208|"A total of 559 sites received IEC/IRB approval in 40 countries and 547 were shipped clinical supplies. Of the 559 sites, 525 screened at least 1 participant.
~An insulin sub-study of MK-3102-018 was performed and included the sub-population of participants receiving ≥20 units/day of background insulin with or without metformin."|On April 8, 2016, Merck & Co. Inc. announced that it would not submit marketing applications for omarigliptin (MK-3102) in the US and Europe for business reasons only. Because of this decision, the MK-3102-018 study was terminated early on May 13, 2016. Due to delays in study close-out the Last-Participant-Last-Visit occurred on March 22, 2017.
731358|NCT01703000|Recruitment of subjects for NG PROMUS study started on November 20, 2012 and completed on March 12, 2013. Subjects were recruited at 9 investigational centers in Australia, New Zealand and Singapore.|
731359|NCT01702987||
731360|NCT01702961||
731361|NCT01702909||
731362|NCT01702896||
731363|NCT01702844|A total of 42 participants were accrued between June 2013 and April 2017 at 7 institutions in the United States|Another 9 participants signed consent but did not start the trial due to screen failure (6), progression of disease prior to study start (1) and withdrawal of consent prior to start (2.)
731364|NCT01702558||A total of 234 participants were screened, out of which, 182 participants were enrolled into the study. Out of the 182 enrolled participants, 3 participants were excluded from all safety and efficacy analyses because they did not sign correct Informed Consent Form (ICF).
731365|NCT01702532|Participants were recruited at the clinical site.|A total of 386 participants were screened of which 322 subjects were randomized into the study. Sixty subjects were screen failures, Two subjects withdrew consent and an additional 2 subjects were not randomized due to other reasons.
731366|NCT01702519|Participants were recruited at a single clinical site in the US.|A total of 128 participants were screened, of which only 40 were randomized into the study. 71 participants did not meet the study eligibility criteria, 4 were lost to follow up, 6 withdrew consent while the remaining 7 were not randomized due to the other reason.
731367|NCT01702454||
731368|NCT01702428|13 subjects from 5016 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started is 5003.|Sub-cohorts for this study were as follows: • US sub-cohort: Subjects recruited in US and received INV_MMR or COM_MMR co-administered with Varivax (VV), Havrix (HAV) and Prevnar (PCV-13) vaccines at Visit 1 (Day 0). • Non-US sub-cohort: Subjects recruited outside US and received INV_MMR or COM_MMR co-administered with VV and HAV vaccines at Day 0.
731369|NCT01702363|A total of 131 Japanese participants with chronic obstructive pulmonary disease (COPD) who met the eligibility criteria were registered and administration of investigational product was started|Participants entered a 7- to 14-day Run-in Period followed by a 52-week Treatment Period. Follow-up was conducted by a phone call approximately 1 week following the completion of treatment or withdrawal from the trial.
731370|NCT01702311|General medicine and surgery patients admitted to Emory University and Grady Hospital between May 2012 and December 2013|
731371|NCT01702298||
731372|NCT01702259||
731373|NCT01702246||
731374|NCT01702233||176 patients have been randomized, 175 of them started treatment. 1 Patient in Treatment arm Traumeel S withdrew consent before first dose.
731375|NCT01702025||19 individual participants enrolled in the study. Participants were provided with the opportunity to re-enroll and enter additional arm(s).
731376|NCT01701999||
731377|NCT01701973|Healthy Lean Adults are randomized to two cross-over studies (Aim 1 and Aim 2).|In Aim 1, Healthy adults were randomized in a double-blinded cross-over fashion to sitagliptin vs placebo. A minimum 8 week wash-out separated Aims 1 & 2. 23 of the same adults who completed Aim 1 participated in Aim 2. In Aim 2, these adults were divided into three subgroups and randomized to sitagliptin+placebo vs. sitagliptin+antagonist.
731378|NCT01701674|Participants were enrolled at Moffitt Cancer Center, April 2013 through July 2014.|
731379|NCT01701622|Recruitment - January 2010 - October 2011 Medical clinic|No significant events or approaches to report.
731380|NCT01701583||
731381|NCT01701505||
731382|NCT01701414|Adult ER patients at Rhode Island Hospital were recruited during the course of their clinical care between January 2010 and January 2012.|Patients were approached after being triaged into the ER system and arrival in a private room but before receiving pain medication for hip fracture. Patients who declined did so because their pain was not severe enough, or they chose not to participate or could not consent, or they were sensitive to morphine (a required component of the study).
731383|NCT01701401|Participants were enrolled at a total of 100 study sites in the United States and Europe. The first participant was screened on 26 September 2012. The last study visit occurred on 30 April 2014.|1015 participants were screened.
731384|NCT01701375|2 subjects were accrued|
731385|NCT01701362|"A total of 187 centers participated in the study in 14 countries.
~During screening, with the exception of daily pain score data that was collected to determine participants eligibility, no participants were treated with active drug and no efficacy data were collected. Only safety and no efficacy data was collected during the taper period."|Participants had clinic visits at screening, randomization, and during the treatment period, and a phone contact for follow-up after the last taper dose. All the eligible participants were randomly assigned (1:1) to 15 weeks of treatment with Pregabalin or Placebo.
731386|NCT01701271|The recruitment started on February 2001 at the University of studies of Pavia|
731387|NCT01701258|Participants were recruited at McLean Hospital (Belmont, MA) between August, 2013, and June, 2017. The study was advertised using flyers, and on a number of internet bulletin boards available to the general public. Study visits were conducted in research facilities at McLean Hospital and Massachusetts General Hospital.|In session 1, subjects had a diagnostic interview, a physical exam, provided a blood sample, and completed surveys, to determine eligibility. Those eligible were invited to participate in the other sessions. Participants did not need to complete all sessions. The order depended on facility availability and convenience for participants.
731388|NCT01701245||
731389|NCT01701115||
731390|NCT01701102||
731391|NCT01701063||The study was planned to be conducted in 2 parts (Part A and Part B), which would use separate groups of participants. However, the study was terminated early (12 weeks after last dose of study drug in Part A) and Part B was not conducted.
731392|NCT01701037|This study opened to accrual at Vanderbilt-Ingram Cancer Center (VICC) in January 2013 and ran through March 2015 when it closed prematurely due to PI's departure.|Thirteen patients participated in this study, all completed the study as defined by protocol.
731393|NCT01701024||
731438|NCT01698268|This single-center, prospective, single blind, randomized study enrolled subjects who were scheduled for elective hydrocelectomy and/or hernia repair at Beaumont Hospital-Royal Oak. The first procedure was on 3/16/2012 and the last one was on 11/12/2014.|
731439|NCT01698008||
731394|NCT01701011|In the 20 months of recruitment, between October 2010 and June 2012, 1445 letters were sent to women with an invitation to the trial.|Of the 565 women who replied via a letter or email, 188 (33%) were not eligible. The remaining 377 women were randomised and the 349 who had an embryo to transfer (n=119 PRCI-monitoring, n=117 monitoring-control, n=113 routine care control)
731395|NCT01700985|"Recruitment period: May 2012 to September 2012
~The location of clinical sites included dermatology clinical research centers."|All subjects who met the entry criteria were randomized and enrolled into the study.
731396|NCT01700959|911 participants were enrolled and screened between February 2013 and June 2017. Of the 911, 298 were ineligible and 33 withdrew prior to randomization. 580 were randomized.|The remaining 580 participants were categorized into three mutually exclusive groups: (1) neurocognitive impairment (NI) without delayed sleep onset latency (DSOL), (2) NI with DSOL, and (3) No NI with DSOL. Participants were then randomized to take melatonin or placebo.
731397|NCT01700907|Twenty patients who were scheduled to undergo general anesthesia in Sapporo Medical University Hospital were enrolled in this study.|"Inclusion criteria were shown as follows: Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients.
~Exclusion criteria were shown as follows: Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients (BMI>35)"
731398|NCT01700829||
731399|NCT01700816||
731400|NCT01700725||
731401|NCT01700621|Study population was drawn from participants living in the International Center for Diarrheal Disease Research, Bangladesh (icddr,b) service area of Matlab, Bangladesh.|Recruitment concurrently conducted at a number of health sites in the study area, which resulted in two additional infants being enrolled but subsequently not vaccinated with withdrawn from the study.
731402|NCT01700530|If meeting qualifications after initial phone screening, subject consented followed by another round of screening to determine if they had 2/5 risk factors or not which eliminated many subjects. Thus the difference between the 121 subjects reported for who signed consents and the 50 who entered the participant flow module.|
731403|NCT01700517|120 patients submitted to TKA in Madre Teresa´s Hospital between 2011 and 2012 by three authors were enrolled in this prospective, randomized, placebo controlled and double-blinded study after receiving three different types of anesthesia.|Non-cooperative patients, with cognitive incapacity to understand the AVS, neuromuscular or peripheral neuropathies, chronicle use of opioids or the ones who didn´t want to take part of the study were excluded.
731404|NCT01700439||934 participants were considered enrolled; however, data are only available for 889 participants.
731405|NCT01700387||
731406|NCT01700348||Of the 257 subjects who signed consent forms, 140 (54.5% were classified as screen failures). 1 additional subject declined to participate after screening but before randomization.
731407|NCT01700335||
731408|NCT01700205|From 2012 to 2015, newly parturient women whose decision not to lactate was firmly established were recruited through ads in regional newspapers, websites and hospitals in the greater Philadelphia area.|
731409|NCT01700192||
731410|NCT01700179|Participants were recruited from 6 sites in the US between September 5, 2012 and December 11, 2012.|Participants were screened within 4 weeks (-28 to -1) before administration of study drug. Subjects who meet all eligibility criteria were instructed to arrive at the study center on baseline day.
731411|NCT01700140||
731412|NCT01700049||
731413|NCT01700036||
731414|NCT01699867||
731415|NCT01699815||
731416|NCT01699789|From March 2010 to November 2010, the study screened 4,440 clients from 93 programs in 50 agencies. The ninety-three programs, included 17 primary care/public health, 18 mental health, 20 substance abuse, ten homeless services, and 28 social/other community services.|
731417|NCT01699763||
731418|NCT01699750|Participants were recruited from 1 study center located in the United Kingdom.|Of the 109 participants enrolled, 39 were exited from the study prior to randomization and product dispense (Phase 2). This reporting group includes all randomized and dispensed participants (70).
731419|NCT01699698||
731420|NCT01699685||
731421|NCT01699607||
731422|NCT01699503||
731423|NCT01699373|April 2011-April 2012 Changi General Hospital|
731424|NCT01699178||
731425|NCT01699087|Participants were recruited from 8 investigative sites located in the United States.|Of the 176 participants enrolled, 15 did not meet inclusion and exclusion criteria and were exited prior to treatment as screen failures.
731426|NCT01699022|The study was conducted at the CONRAD Clinical Research Center (CRC) located in the Jones Institute for Reproductive Medicine at the Eastern Virginia Medical School (EVMS) in Norfolk, vasectomy (VA) in subjects with previous surgical sterilization and therefore were not at risk for pregnancy|A total of 7 women failed screening: 3 women had control cycle luteal phase serum P < 3 ng/mL; 3 women withdrew consent; and 1 potential subject was not enrolled because the study had enrolled the requisite number of subjects and was closed for enrollment
731427|NCT01698814|Subjects were recruited from 15 study centers located in the United States.|Of the 518 enrolled subjects, 18 subjects were exited from the study as screen failures. This reporting group includes all randomized subjects.
731428|NCT01698801||This is an ongoing open-label, single arm, 5 year study consisting of a 28-day screening period followed by a treatment period where participants receive lenalidomide and dexamethasone until their disease progresses or the lenalidomide is discontinued for any reason. This report includes data up to the cut-off of 15 July 2014.
731429|NCT01698775||
731430|NCT01698710||
731431|NCT01698684||
731432|NCT01698554||
731433|NCT01698528||
731434|NCT01698502||
731435|NCT01698463||No pre-assignment of participants to groups.
731436|NCT01698333|"Recruitment period: April 2012 to March 2013
~The location of clinical sites included private dermatology clinics and clinical research centers."|All subjects who met the entry criteria were enrolled into the study.
731437|NCT01698320||Of the 33 patients who were screened but not enrolled, 28 were excluded on the basis of inclusion/exclusion criteria, 2 patients withdrew consent, and 3 patients were lost to follow-up before the baseline visit.
754275|NCT00437203||
731440|NCT01697969|Participants were recruited from 1 study center located in the United States.|Of the 17 participants enrolled, 4 were exited from the study as screen failures prior to exposure to the test product. This reporting group includes all participants exposed to the test product (13).
731441|NCT01697956||A total of 110 subjects were screened. Participants were randomly assigned to either BDP nasal aerosol (80 mcg/day) or placebo nasal aerosol in a 2:1 ratio.
731442|NCT01697800||
731443|NCT01697748|"Recruitment was from September 2013 through June 2016. The 6 week post operative visits were completed August 2016.
~Recruitment was at University of South Florida South Tampa Campus, Tampa General Hospital Healthpark Genesis and Tampa General Hospital Tampa Florida Labor and Delivery Triage."|3 patients were inadequately consented, two in the Silverlon dressing group and one in the Telfa dressing group
731444|NCT01697709||Patients were randomized to one of the treatment arms at time of enrollment
731445|NCT01697696||
731446|NCT01697592|Sixty-seven sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. A total of 772 participants were screened of which 187 participants were excluded. The most common reason for participants not being randomized was screen failure (meeting exclusionary laboratory values).|In Phase A, participants were randomized to receive either omarigliptin (MK-3102) 25 mg once weekly or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.
731447|NCT01697579|This study enrolled participants scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for no more than 5 consecutive days and were expected to receive ondansetron as part of their antiemetic regimen. Additional inclusion and exclusion criteria applied.|Participants (2 to <6, 6 to <12 and 12 to17 years-old) were enrolled in a randomized, partially-blinded study of 4 doses of fosaprepitant and a control in Cycle 1. Participants (0 to <2, 2 to <6 and 6 to <12 years-old) were invited to participate in optional Cycles 2-6 which was an open-label study of 2 doses of fosaprepitant.
731448|NCT01697501|Participants in the safety analysis set included 88 patients with HBeAg-negative chronic hepatitis B enrolled at 12 study centers in Italy.|Participants in the full analysis set included 86 previously enrolled in the predecessor study ML18253 (NCT01095835), during which they were treated.
731449|NCT01697462||
731450|NCT01697449||
731451|NCT01697358|A total of 278 subjects were recruited between January 2013 and August 2015 from 28 sites in Canada, Colombia, Europe, and US.|A total of 60 subjects didn't meet the inclusion and/or exclusion criteria and discontinued from the study before randomization.
731452|NCT01697345|Participants were prospectively recruited from Nebraska Cancer Specialists in Omaha, NE, between January 11, 2013, and April 23, 2013.|During the first study visit, the the PI procured a vaginal swab because women with suppressed estrogen levels have an increased risk for infection. Also, in the clinical setting, the PI has observed that women who develop a yeast or bacterial infection while using vaginal testosterone frequently report symptoms of vaginal burning or irritation.
731453|NCT01697332||
731454|NCT01697319||
731455|NCT01696994|Participants were enrolled between November 1993 and July 2001 at 10 study centers.|Participants signed a study informed consent prior to being randomized to a study arm.
731456|NCT01696981|Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).|Participants signed a study informed consent prior to being randomized to a study arm.
731457|NCT01696968|Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).|Participants signed a study informed consent prior to being randomized to a study arm.
731458|NCT01696955||
731459|NCT01696942||
731460|NCT01696929||
731461|NCT01696877||
731462|NCT01696773||
731463|NCT01696760||
731464|NCT01696695||
731465|NCT01696643||
731466|NCT01696396|"This study was conducted at 84 centers in Canada, European Union, and the United States. Participants were enrolled from 04 December 2012 to 30 September 2014.
~The study consisted of a 24-week double-blind treatment period, a 108-week open-label treatment period, and a safety follow-up period."|Participants were to be randomly assigned in a 2:1:2:1 ratio to 1 of 4 treatment groups. Due to a misalignment error, some participants were erroneously assigned to incorrect treatment resulting in a final randomization ratio different from that originally stipulated in the protocol.
731467|NCT01696357||
731468|NCT01696279|The study was conducted at 23 study centers between 15 February 2013 (first participant first visit) and 16 November 2018 (last participant last visit).|It was a 3 part study (Part 1: Pharmacokinetic assessment, Part 2: [Part 2a-calcium carbonate and lanthanum carbonate {crossover comparison} or Part 2b-lanthanum carbonate], Part 3: lanthanum carbonate treatment for 6 months). Overall 63 participants enrolled in the study.
731469|NCT01696214||
731470|NCT01696188||
731471|NCT01696084||
731472|NCT01696071||
731473|NCT01696058||1137 patients were entered and randomized to treatment and 1135 patients were treated with study medication.
731474|NCT01696045||14 participants were enrolled in the study. 12 participants received study treatment. 2 participants were enrolled and not treated because they no longer met study criteria.
731475|NCT01695993||
731476|NCT01695954|Accrual began August 24, 2012 and ended January, 8, 2013. All study procedures took place at the NYU/Bellevue Clinical Trials Unit and NYU Clinical and Translational Science Institute.|
731477|NCT01695772||Protocol did not specify any particular 5-Flurouracil (5-FU) based doublet chemotherapy regimen. The choice of 5-FU based doublet chemotherapy was as per standard of practice and the dosage of 5-FU based doublet chemotherapy was as per product labels.
731478|NCT01695746|A total of 108 participants were enrolled in this study conducted from 30 August 2011 to 13 November 2013 at 6 sites in India.|
731479|NCT01695668||
731480|NCT01695369||Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye. The subject is expected to attend the baseline visit not wearing their habitual contact lens products for at least 12 hours.
731484|NCT01695239||The Double-Blind Treatment Period was Week 0 up to Week 24 (Inadequate responders (IR) Week 16-24) followed by the combined extension period and long-term extension period from Week 24 to Week 156.
731485|NCT01695135|A total of 214 participants were enrolled in the study (143 participants in abiraterone acetate group and 71 participants in placebo group).|
731486|NCT01695044||
731487|NCT01694966||
731488|NCT01694771||1134 patients were entered and randomized to treatment and 1132 patients were treated with study medication.
731489|NCT01694706||This was a randomised open label, 3-way cross over study with three sequences. Faldaprevir administrations in each treatment period were separated by washout period of at least 14 days.
731490|NCT01694667|Recruitment was limited to children between the ages of 5 and 8 with ASD and some verbal ability. E-mail invitations were sent to the 863 registered IAN members who met the above criteria and had given prior consent to be contacted about research opportunities between September 18, 2012 and October 31, 2012.|During the six-week recruitment period, 118 families expressed interest and completed the on-line screening form. Fifty-seven children from 28 states were deemed eligible and randomly assigned to study treatment.
731491|NCT01694641||
731492|NCT01694563|Subjects were enrolled from: September 2012 thru October 2017|
731493|NCT01694485|"Participants were enrolled at 92 centers located in North America, Europe, and Australia from 16 November 2012 to 11 May 2015.
~The study consisted of a 24-week double-blind treatment period, a 108-week open-label treatment period, and a safety follow-up period."|Participants were to be randomly assigned in a 2:1:2:2:2 ratio to 1 of 5 treatment groups. Due to a misalignment error, some participants were erroneously assigned to incorrect treatment resulting in a final randomization ratio different from that originally stipulated in the protocol.
731494|NCT01694433||
731495|NCT01694420|Participants for this study are recruited from AHI participants referred to our ID clinics. Referrals are generated from the NC STAT Program and from clinical diagnoses made by both internal and external health care clinics.|
731496|NCT01694199||
731497|NCT01694186||
731498|NCT01694121|one individual was enrolled and surveyed twice. He remained in the study, but the initial survey was not included.|
731499|NCT01694108||
731500|NCT01693900|This single-center, prospective, randomized study enrolled 50 subjects who were scheduled for elective anterior hip replacement. Once informed consent was obtained, patients were randomized to either preoperative ultrasound-guided fascia iliaca compartment block (FICB) or intraoperative surgeon-placed FICB.|
731501|NCT01693653||
731502|NCT01693614||Primary reason for not completing is presented
731503|NCT01693523|Recruitment period: February 20, 2013 to October, 20 2015. All recruitment done at the University of Texas MD Anderson Cancer|Of the 80 participants enrolled 1 participant were excluded from the study before assignment to groups.
731504|NCT01693484||
731505|NCT01693367|The multicenter international study enrolled patients with distal femur fractures which were either stabilize with a Dynamic Locking Screw or a standard locking screw. The study was stopped due to implant breakages observed after planned implant removals in non-study patients treated with the DLS 5.0mm.|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits.
731506|NCT01693250|The trained research assistant worked with primary care providers at two large community clinics whose patient populations were predominantly Chinese American in northern California. A study invitation letter was posted in the clinics. Pediatricians at the clinics were also given a study invitation letter to give to potential participants.|An explanation of why potential participants were excluded from the study before assignment to groups was given them.
731507|NCT01693185|Predetermined patient identification numbers and enrolment order were placed in sealed envelopes, and all patients were randomly assigned, at recruitment, to the midazolam-meperidine combination (group-MM) or remifentanil alone (group-R). If a patient was excluded during the study, the following patient assumed the status of the excluded patient.|The exclusion criteria were applied. If a patient was excluded after recruitment and enrollment into the study, the following new patient assumed the status of the excluded patient.
731508|NCT01693120|The first subject was enrolled on 05 November 2013 and the first Phased RF procedure occurred on 17 December 2013. Enrollment into the VICTORY AF study was closed on 26 June 2016 prior to reaching the target sample size due to slower than expected enrollment rate.|
731509|NCT01693068|First/last subject (informed consent): 05 December 2012/04 June 2014. Cut-off date: 04 July 2015. Last subject last visit: 24 October 2016.|A total of 194 subjects were randomized in trial. Data presented based on the cut-off date of 04 July 2015.
731510|NCT01693029||
731511|NCT01692964|The recruitment took place over a 7-month period. The study was performed at private practices and academic centers.|
731512|NCT01692951||
731513|NCT01692938|Recruitment Dates - 10/5/2012 to 11/5/2012. 3 Ophthalmic Clinics.|
731514|NCT01692782||
731515|NCT01692756||
731516|NCT01692743||
731517|NCT01692730||
731518|NCT01692691||
731519|NCT01692626||
731520|NCT01692496|From 2013 to 2018, advanced and/or metastatic liposarcoma patients were recruited across 12 centres from Spain and Germany.|"Patients were clustered in two cohorts based on the liposarcoma type:
~Cohort A: well differentiated liposarcoma
~Cohort B: Myxoid/round cell liposarcoma
~Both cohorts were included in the single arm treatment: Pazopanib"
731521|NCT01692340|We completed the first two arms of the study with isotopically labelled lycopene and phytoene, however our funding was exhausted after the second arm and we did not complete the isotopically labelled phytofluene arm.|
731522|NCT01692301||
731523|NCT01692275||
731524|NCT01692197|Recruitment Period: 2/2013 to 06/2014|Of the 43 participants registered, three never received the study medication.
731525|NCT01691950||
731526|NCT01691898|A total of 289 participants were screened, out of which, 231 participants were enrolled into the study.|
731752|NCT01679028|"Study Initiation Date: Auguest 1st, 2012
~Study Completion Date: October 20th, 2012
~Location: Phase I clinical Study Center:
~California Clinical Trials Medical Group 1509 Wilson Terrace Glendale, CA 91206"|
731527|NCT01691885||At Visit 1a, participants who met the eligibility criteria stopped their respiratory medication in preparation for their lung volume assessment at screening Visit 1b. At Visit 1b, participants entered a 7(plus or minus 3) day Run-in Period. Overall study duration, following Screening to Follow-up, was 36 days up to a maximum of 54 days.
731528|NCT01691859|This was a multi-center, open-label, long term safety study of mepolizumab in 347 asthmatic participants who participated in the MEA112997 trial and were found eligible for this study after screening and run in phase. The study was conducted at 65 centers in 13 countries from 28 Sep 2012 to 31 May 2017.|A total of 362 participants were screened; 4 participants were screen failures (did not meet the inclusion/exclusion criteria); 11 participants were withdrawn during the run-in period (4 did not meet the continuation criteria, 4 withdrawal by participant and 3 following physician decision).
731529|NCT01691833||
731530|NCT01691820|Enrolment was terminated once approximately 240 seropositive subjects were included in the trial, to obtain approximately 200 evaluable seropositive subjects. The number of seronegative subjects enrolled depended on the seroprevalence of the participating countries.|Of the 369 enrolled subjects, 363 are the adolescent female subjects and 6 are newborns of some subjects. Consent was signed for the newborns to allow testing for CMV disease. The objectives have assessed the CMV infections in only the adolescent females; no baseline demographics, outcome measures, or adverse events were assessed in newborns.
731531|NCT01691794||Overall, 108 participants were enrolled, and 59 received treatment.
731532|NCT01691781||All enrolled participants had to undergo a washout of ACE inhibitors (if applicable) during which time their blood pressure had to remain within safety parameters, and they had to complete a controlled sodium diet.
731533|NCT01691768||448 were assessed for eligibility and 382 were randomized. However, only 372 were eligible for study participation. Of the 10 who were ineligibly enrolled: 6 were HIV positive at enrollment, 2 were co-enrolled in another trial, 1 had no post-randomization follow-up data and 1 was pregnant at enrollment.
731534|NCT01691690||
731535|NCT01691612||
731536|NCT01691560|Participants were recruited at the clinical site.|Out of 152 screened participants, 16 did not meet the study criterion while 2 withdrew consent. Hence, a total of 134 participants were randomized into the study.
731537|NCT01691534||
731538|NCT01691521|Par. who met the eligibility criteria at screening, entered the Run-in period for a minimum of 1 week and a maximum of 6 weeks. Par. who received all 8 doses and met the eligibility criteria were offered the opportunity to participate in an open label extension (OLE) study. Par. not entering the OLE study completed the Follow-up Visit.|A total of 802 participants (par.) were screened; 82 were Screen failures; 140 were Run-in failures; 580 were randomized, of which 576 received at least 1 dose of study drug.
731539|NCT01691508|The study consisted 4 phases: oral corticosteroids (OCS) Optimization (Run-in); Induction; OCS Reduction and Maintenance. Participants (par.) who completed the 4 phases and met the eligibility criteria were offered the opportunity to participate in an open label extension (OLE) study. Par. not entering the OLE study completed the Follow-up Visit.|A total of 185 par. were screened; 3 par. were Screen failures; 47 par. were Run-in failures; 135 par. were randomized and received >=1 dose of study drug.
731540|NCT01691482||This was a randomized, open-label, two-period cross-over study to evaluate the daily bronchodilator response to albuterol/salbutamol and ipratropium individually and in combination in participants with chronic obstructive pulmonary disease.
731541|NCT01691430|Recruited from nursing homes within 50 miles of New Haven.|806 patients were eligible, 558 declined to participate. Of the 248 consented, 63 were found to be ineligible after consent, leaving 185 to randomize.
731542|NCT01691378||No significant issues
731543|NCT01691339|The study participants were enrolled from 19 through 27 September 2012 at 4 clinic centers in the United States.|A total of 200 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
731544|NCT01691326|The study participants were enrolled from 19 September 2012 to 12 December 2012 at 2 clinic centers in the United States.|A total of 60 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
731545|NCT01691313||
731546|NCT01691248||
731547|NCT01691105||
731548|NCT01691092||
731549|NCT01691079|PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.|
731550|NCT01691027|Subjects with bilateral AMD, no foveal vision, and acuities poorer than 20/60 in each eye were screened in the eye clinic and those who met inclusion criteria were enrolled in the study. On each laboratory visit, subjects' eyes were checked for angle closure and, if angles wee open, dilated the eye to be tested|Enrolled subjects when found to have residual foveal vision in baseline SLO retinal functional map and/or are unable to follow the instructions for SLO testing were excluded from the study before training assignment.
731551|NCT01691014||
731552|NCT01690988||746 participants were consented to the study; however only 672 were randomly assigned as 74 participants were determined ineligible after consent. Reasons for ineligibility: operations were cancelled or patients withdrew from the study, etc.
731553|NCT01690923|Participants recruited from ResMed Science Centre, Sydney, between Aug 2011 and Aug 2012|
731554|NCT01690663||
731555|NCT01690546|38 participants signed consent. 3 participants were screen failures. 35 participants started study.|
731556|NCT01690299|The study was conducted at 65 study centers in 11 countries.|Participants were randomized 1:1:1 to the three treatment groups. Participants were stratified according to their calculated body mass index (BMI) categories at Screening (BMI < 30 or BMI ≥ 30).
731557|NCT01690273|Two hundred nine consecutive patients from the division of rheumatology outpatient clinic of the university hospital (Clinics Hospital of University Medicine School of Sao Paulo) diagnosed with AS according to the modified New York criteria, were invited to participate. Fifty Five individuals were randomly allocated into three groups|Seventy patients did not accepted and 84 did not followed inclusion criteria. Fifty five were allocated into three groups after following the inclusion criteria.
731558|NCT01690143||
731559|NCT01690130||
731560|NCT01690117||
731753|NCT01679002||
731754|NCT01678976||
731755|NCT01678924||
731561|NCT01690052|Patients were recruited from the Salivary Gland Dysfunction Clinic at the U. of K. A cross-over double-blind randomized trial was designed. Two arms were assembled. First arm the SEQUENCE was cevimeline(C) then pilocarpine(P), and for the second the SEQUENCE was P then C. Each participant received the drug for 4 weeks with 1 week washout period.|The total number of patients screened for the study was 28. Of 28 patients, 15 met the inclusion criteria
731562|NCT01690000|We recruited 81 postmenopausal women with osteopenia to receive either melatonin (n=40) (1 or 3 mg) or similar placebo (n=41) nightly for 12 months. In addition, all women received a daily supplementation with 800mg calcium and 20ug D3|A total of 202 women were invited to participate. 81 were included in the study
731563|NCT01689974||
731564|NCT01689909||
731565|NCT01689857|This study was conducted at Seoul National University Bundang hospital. Forty subjects were recruited from May, 2010 to April,2012.|In this study, we had no run-in period before study was commenced and there were no subjects who drop out before enrollment and randomization to groups.
731566|NCT01689779||
731567|NCT01689740|Participants were recruited through printed ads, internet ads, referrals from other psychiatrists, psychotherapists or physicians, through the Israeli Defense Forces (IDF) and through word of mouth.|
731568|NCT01689701|The study subjects were recruited from Clinical Trial Center for Functional Food in Chonbuk National University Hospital during the 2011. Only those subjects who were Subjects Showing Erosive Gastritis and were not diagnosed with any disease were included in this study.|Among the 79 subjets screened, 25 subjects had endoscopy and/or laboratory tests results that were in the exclusion criteria category, hence they were excluded from the study.
731569|NCT01689649|139 epileptic participants from three participating centers (Neurological department of the Central (Vietnam-Sweden) Pediatrics Hospital, Neurological department of Children's Hospital N0 II at Ho Chi Minh City and the Children's Outpatient Clinic of the Mental Hospital at Ho Chi Minh City) were enrolled in this study to receive topiramate.|Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
731570|NCT01689532||Of the 180 participants who signed informed consent of this study, 122 participants (61 participants in each treatment group) were randomized and treated during the study.
731571|NCT01689519||Written informed consent for participation in the study was obtained before performing any study-specific screening tests or evaluations.
731572|NCT01689441||
731573|NCT01689363||
731574|NCT01689350||
731575|NCT01689337||Sprifermin (AS902330) 30 microgram (mcg) and placebo arms were planned, but did not enroll participants due to early study discontinuation.
731576|NCT01689324|The study participants were enrolled from 12 September through 14 October 2012 in 3 clinic centers in Japan.|A total of 43 participants that met all the inclusion criteria but none of the exclusion criteria were enrolled and vaccinated in the study.
731577|NCT01689207|First subject enrolled 27 September 2012 and last subject last visit was 30 December 2014. Subjects were healthy male and female volunteers both young and elderly. Healthy volunteers were given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study and could discontinue at any time.|A Screening visit was conducted within 28 days before admission to the study centre. 222 volunteers were screend, 92 volunteers were entered into the study. Healthy volunteers were admitted to the study centre on Day -1 of either Part A, Part B or Part C.
731578|NCT01689155|Study participant accrual occurred from 16 June 2011 through 20 June 2014.|Databases of Kaiser Permanente in Northern California (KPNC) were reviewed to describe and characterize adverse events occurring after use of Menactra vaccine in routine clinical practice. Rates of events occurring in a risk window for participants were compared with rates of events occurring in a control window for the same participants.
731579|NCT01688999||
731580|NCT01688973||
731581|NCT01688921||
731582|NCT01688895||
731583|NCT01688882||
731584|NCT01688856||
731585|NCT01688843||
731586|NCT01688830|"The study is conducted in two parts:
~Parts 1 and 2 had a single rising dose design; subjects in Part 3 received 2 single doses 1 h apart.
~Part 1: 8 subjects per dose group Part 2: 12 subjects per dose group Part 3: 12 subjects per dose group"|
731587|NCT01688739|"This study was conducted at a single center in Belgium from March 2012 to March 2013.
~The study enrolled healthy participants (Part 1) and participants who had migraines for at least 6 months and at least 3 migraine attacks per month in the last 3 months (Part 2)."|Healthy participants were randomized in a 3:1 ratio to erenumab or placebo within each dose cohort. Migraine participants were randomized in a 1:1 ratio to erenumab or placebo.
731588|NCT01688726|Participants were recruited from 1 clinical site located in the UK.|A total of 91 participants were enrolled and randomized. This reporting group includes all randomized participants (91).
731589|NCT01688635||The study comprised 2 sequences with 4 treatment periods. Participants were randomly assigned to 1 of the 2 sequences.
731590|NCT01688609||
731591|NCT01688596|Patients undergoing laparoscopic surgery at Penn State Milton S. Hershey Medical Center were recruited between 3/13 and 6/13. Allocated to CPP or no CPP based on usual clinical definitions.|Patients in each group (Chronic Pelvic Pain and No Chronic Pelvic Pain) were randomized to receive either a bupivacaine block at each trocar site or no block. Standardization of amount of local block received was based on trocar size of 5mm or less vs. 8mm and or greater.
731592|NCT01688466||
731593|NCT01688336|11 patients were consented. One patient was consented but not treated due to metastatic disease and one patient was consented and not treated due to disease progression prior to protocol therapy. 9 patients went on study.|
731594|NCT01688310|Recruitment between October 30, 2012 and February 2, 2013. University teaching clinic.|"241 interviewed, Excluded (n=41)
~Inclusion criteria not met (n=19)
~Under 18 years of age (n=17)
~Phimosis (n=2)
~Declined to participate (n=22) 200 were randomized and underwent circumcision in the arm allocated"
731595|NCT01688141||
731596|NCT01688102||
731597|NCT01688050||
731790|NCT01676415|Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.|
731598|NCT01688037|This study enrolled patients with a clinical diagnosis of schizophrenia or schizoaffective disorder with moderate or severe tardive dyskinesia (TD) from 35 centers in the United States and Puerto Rico. The last patient completed in October 2013.|
731599|NCT01687998||"Non-Completers: Participants Known to be Alive at Study End is a subset of those who did not withdraw consent and later found to be alive from public sources. Lost to follow-up is a subset of those who did not withdraw consent for whom study end vital status could not be ascertained."
731600|NCT01687972|187 were consented, and 88 were randomized to intervention versus placebo.|
731601|NCT01687790|single group|
731602|NCT01687712|1548 subjects were enrolled, 1101 subjects were randomized and 1100 received Investigational Medicinal Product (IMP) at 22 investigational sites in the United States.|After the informed consent was signed, each subject received a subject identification number and underwent the down-regulation procedure. After a successful downregulation, subjects were centrally randomized in a 1:1 ratio to one of the treatment groups, AFOLIA or Gonal-f®RFF.
731603|NCT01687673||
731604|NCT01687478||
731605|NCT01687413||
731606|NCT01687400|The study opened to participant enrollment on 02/12/2013 and closed to participant enrollment on 06/19/2017.|
731607|NCT01687387|169 patients were screened and 152 patients were randomized and treated in France|
731608|NCT01687296|The study was planned on 250 Chinese paediatric and adolescent participants (aged 4 to 16 years) with an acute exacerbation of asthma and was conducted at 11 centres in China from 12th November 2012 to 21st June 2013.|A total of 266 participants (par) were screened for this study. Of these, 5 participants were screen failures. A total of 261 participants were randomized to receive either nebulized fluticasone or oral prednisone. A total of 251 participants received at least a single dose study drug.
731609|NCT01687283|A total of 317 Chinese adults and adolescents aged >= 17 years and <= 70 years with severe persistent asthma were planned to be enrolled in study. This study was conducted from 27-September-2012 to 7-November-2013.|Out of 460 screened participants, 109 were screen failures and 34 were run-in failures. Out of 317 participants, two participants did not receive the study drug and 315 participants received the study drug.
731610|NCT01687270|Participants were enrolled at a total of 12 study sites in the United States, Europe, and New Zealand. The first participant was screened on 26 October 2012. The last participant observation occurred on 14 August 2014.|49 participants were screened.
731611|NCT01687257|Participants were enrolled at study sites in the United States, Europe, Australia, and New Zealand. The first participant was screened on 27 November 2012. The last study visit occurred on 06 October 2015.|63 participants were screened.
731612|NCT01687244||
731613|NCT01687218|HIV-uninfected males or transgender females who were 18 years of age or older who practice receptive anal intercourse were recruited from September 2013 through November 2014 from 8 sites in Peru, Puerto Rico, South Africa, Thailand and USA.|349 persons were screened and 154 were excluded for various reasons. The study enrolled 195 participants, 187 of whom are evaluable. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.
731614|NCT01687179||
731615|NCT01687166||
731616|NCT01687114||
731617|NCT01687101||
731618|NCT01687088||
731619|NCT01687036|Recruitment period: September 3,2012 - December 14, 2012 Locations: Medical University Innsbruck, General Hospital Linz|
731620|NCT01686958||
731621|NCT01686932|Period 1: 8 weeks treatment with vildagliptin 50mg BID or sitagliptin 100mg QD, 1-4 weeks wash-out, followed by Period 2, 8 weeks treatment with sitagliptin 100mg QD or vildagliptin 50mg BID|
731622|NCT01686828|Recruitment period: 06/01/13-11/30/2014 Location: University/Medical Center Flyers, newspaper ads, online postings|116 subjects were screened, 63 subjects didn't meet study inclusion/exclusion criteria or they withdrew consent prior to group assignment, and 3 subjects withdrew prior to the baseline visit.
731623|NCT01686750|Recruited by respondent-driven sampling in 22 sites in India.|
731624|NCT01686646|Participants were recruited at the clinical site.|Out of 244 participants screened, 4 did not meet the study criteria. Remaining 240 were randomized into the study.
731625|NCT01686633|Participants meeting eligibility criteria at the Screening visit entered a 4-week Run-in Period for Baseline safety evaluations and measures of asthma status. Participants were then randomized to a 12-week Treatment Period. A total of 2019 participants were screened; 1039 were randomized and received >=1 dose of study treatment.|One participant was determined to have been randomized at each of two United States sites. Upon discovery of the duplicate enrollment, the participant was withdrawn. To account for only one randomization by this participant, a total randomized population of 1039 was used as the basis for the study analysis.
731626|NCT01686581||
731627|NCT01686568|Participants were recruited from the Mayo Clinic in Rochester, Minnesota.|
731628|NCT01686503||
731629|NCT01686451|From August 10, 2012, through September 15, 2013, 243 patients were screened and 60 patients who met the inclusion criteria were enrolled and randomly assigned to either simvastatin (33 patients) or xuezhikang (27 patients) at medical clinic.|183 eligible patients were excluded with 160 patients declined to participate while 19 patients were currently using lipid-lowering medications, 3 patients were suffering from chronic kidney disease or active liver disease and 1 was of currently childbearing.
731630|NCT01686438|114 participants were consented and randomized in the study. 87 of those participants started in treatment in this study. Of those, 57 completed treatment sessions. 55 of the 57 who completed treatment are included in the analysis of this study.|
731631|NCT01686373||
731632|NCT01686165||
731633|NCT01686152||
731634|NCT01685996||
731635|NCT01685983||
731636|NCT01685840||894 participants were randomized
731637|NCT01685801||
731638|NCT01685697|March 2013 to September 2013|The study used deferred consent approach. In this approach patient are randomized and asked to participant afterwards because of minimal risk to participation this study. Therefore there are a larger number of participant at the start date of the study and if they decline to participate a lower enrolled number.
731791|NCT01676311||
731639|NCT01685684||The titration (i.e., enrichment) phase of the study was designed to titrate patients to a dose of Oxycodone DETERx that balanced pain control and tolerability to ensure that only patients who experienced a substantial reduction from the screening pain assessment and who can tolerate side effects continue into the Double-blind Maintenance Phase.
731640|NCT01685606||
731641|NCT01685567|Recruitment opened November, 2012 and ended March, 2016.|
731642|NCT01685463||
731643|NCT01685437||
731644|NCT01685372|Study subjects were recruited over two influenza seasons, 2013-2014 and 2014-2015. Subjects were recruited from the Dialysis unit and Rheumatology clinic in 2013-2014 by referral from clinicians. Subjects were recruited by mailed letter to Solid Organ Transplant recipients in 2014-2015.|In 2013-2014, 4 subjects chose not to enroll after learning more about the study. In 2014-2015, 2 subjects chose not to enroll after learning about the study. All potential subjects met pre-screening criteria. No subjects were excluded from the study by study personnel.
731645|NCT01685320|Date of recruitment period: January-October 2011. Type of location: Dept. of Anaesthesia, University School of Medicine Campus Bio-Medico, Rome, Italy.|After written consent, thirty adult patients scheduled for elective surgery under general anaesthesia (age between 18 and 65 years, body-mass index between 18 and 30, classified as ASA-PS class 1 or 2), were included in this study. Subjects likely to be difficult to intubate, according to the SIAARTI Recommendations, were excluded.
731646|NCT01685242|Subjects were recruited from one site in the US.|There were 100 subjects enrolled, 4 subjects discontinued, and 96 subjects completed the study. Participant flow and baseline characteristics are presented for the 100 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.
731647|NCT01685229||
731648|NCT01685216||
731649|NCT01685203||The study originally planned to enroll Group 5 (GT4 treatment-experienced, 2-DAA regimen for 12 weeks), but based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher SVR rates among participants receiving the 2-DAA regimen with RBV, Group 5 was not opened to enrollment.
731650|NCT01685138|Approximately 105 patients were planned to be enrolled. A total of 124 patients were enrolled and treated with ceritinib.|
731651|NCT01685073||
731652|NCT01685060||Approximately 137 patients were planned to be enrolled. A total of 140 patients were enrolled and treated with ceritinib.
731653|NCT01685047||
731654|NCT01685021||
731655|NCT01684943||"29 enrolled in Multiplex PK profiling, 9 were ineligible. 21 completed.
~3 enrolled in the CIM arm of the trial. 2 completed, 1 was excluded from analysis.
~1 subject enrolled in both study phases. They completed the MultiPK profiling experiments, but were excluded from the CIM analysis.
~Total protocol enrollment was 33."
731656|NCT01684930|10,817 patients were screened, 898 potential study candidates were identified, and 32 subjects signed consent and were enrolled from June 2012 through July 2014. Of the 32 subjects who signed consent, 5 subjects were screen failures and 1 withdrew consent. 26 subjects were randomized and 22 subjects completed all study testing.|
731657|NCT01684917||
731658|NCT01684878||A total of 208 participants were entered into the study, 52 participants in Part 1, and 156 participants in Part 2 of the study. Of these, 203 received treatment with pertuzumab or pertuzumab-placebo (50 participants in Part 1 and 153 participants in Part 2).
731659|NCT01684839|Nine patients were included in the study. These patients were treated with the pedicled nerve flap. The type of location was medical clinic.|No wash out, run-in or transition happened in the study.
731660|NCT01684826|The enrollment of patients occurred between 11 September and 23 November 2012.|50 patients enrolled the study one subject withdrew consent.
731661|NCT01684748||
731662|NCT01684722||
731663|NCT01684592|The sample was drawn from a population of low-income pregnant women attending their first prenatal visit at an obstetrics clinic in Baltimore, MD. In total, 790 women (i.e., smokers and non-smokers) were assessed for eligibility from March-December 2013, with 180 meeting eligibility criteria. Of those screened, 130 participants were enrolled.|Randomization occurred at week 26 gestation, after intake data was collected.
731664|NCT01684566||
731665|NCT01684436||
731666|NCT01684423|The study was conducted at multiple centers in 10 countries worldwide between 19 February 2013 (first subject first visit) and 01 September 2016 (last subject last visit).|A total of 68 subjects were screened, of these 4 subjects failed screening. The remaining 64 subjects were randomized, of whom 63 subjects were treated.
731667|NCT01684410|A total of 41 subjects provided informed consent and were screened for the study. Eleven (11) subjects were screen failures, and a total of 30 subjects were randomized to one of three treatment groups: 200 mg or 100 mg of Alpha-1 HC or placebo daily.|
731668|NCT01684215||Study comprised of 2 phases: Participants were enrolled to dose escalation cohorts (PD-0332991 100 milligram [mg] and 125 mg) in Phase 1 Part 1, to maximum tolerated dose (MTD) cohort (PD-0332991 125 mg+ Letrozole 2.5 mg) in Phase 1 Part 2 and to expanded cohort (PD-0332991 125 mg and Letrozole 2.5 mg) in Phase 2.
731669|NCT01684046|Participants were recruited from 5 study centers located in the US, 2 study centers located in the UK, and 3 study centers located in Germany.|Of the 196 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (192).
731670|NCT01684033|Participants were recruited from 5 study centers located in the US, 3 study centers located in the UK, and 2 study centers located in Germany.|Of the 207 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (198).
731671|NCT01684020||
731672|NCT01684007|Subjects were recruited from 8 investigative sites located outside the USA, including Argentina (1), Chile (1), Germany (2), Netherlands (2), and Spain (2).|Of the 112 subjects enrolled, 9 were discontinued prior to randomization as screen failures. This reporting group includes all implanted subjects (103).
731673|NCT01683994||49 participants were enrolled on this study. 4 participants were screen failures and were not assigned to any treatment groups. Data is shown for 45/49 participants. 13 participants were assigned to Ph II Arm A Docetaxel & Prednisone but only 12 started treatment; one participant declined to start treatment. Data is shown for 45/49 participants.
731675|NCT01683838|The randomization schedule was created prior to the start of the study, and was blocked and stratified by site and by concomitant anti-spasmodic medication status to ensure treatment balance between patients who were treated with anti-spasmodic medications upon entry into the study and those who were not.|Investigational drug assignments were communicated through an Interactive Voice Response System (IVRS).
731676|NCT01683812||
731677|NCT01683630||
731678|NCT01683604||
731679|NCT01683565||
731680|NCT01683526||
731681|NCT01683409|The study included a 24-week treatment period and a 4- to 8-week washout period where study drug was discontinued. Time to loss-of-treatment benefit (defined as a failure to maintain a 30% decrease in UACR from baseline) was evaluated at Week 28. Participants who maintained treatment benefit were followed for an additional 4 weeks.|Participants in each baricitinib dose group were classified by their baseline estimated glomerular filtration rate (eGFR) into higher (50 to 70 milliliter [mL]/minute [min]/1.73 meters squared [m²]) and lower (25 to <50 mL/min/1.73 m²) eGFR strata. Participants in the lower strata had their dose adjusted to a lower dose.
731682|NCT01683383|131 infants were screened for eligibility at nine participating NICUs between October 1, 2012 and September 27th, 2013. Eligible infants had a gestational age of at least 35 weeks, met institutional criteria for use of therapeutic hypothermia, and a decision had been made to initiate cooling in transport.|Infants were excluded if they had a lethal congenital or chromosomal anomaly, the decision had been made to not provide full intensive care, or there was refusal of consent. Of 131 infants screened for eligibility, 30 were excluded, and 101 consented and were randomized.
731683|NCT01683331||Of 42 participants randomized prior to kidney transplantation at University of Michigan, 6 did not undergo study procedure due to medical conditions that developed in the immediate postoperative period which prevented them from going forward in the study. Data are not available on the 209 participants randomized through the University of Austria.
731684|NCT01683266|A total of 846 participants were screened, of whom 297 participants were screen failure and 549 participants were randomized.|
731685|NCT01683071|Participants were recruited between September 24, 2012 and December 20, 2013 at 23 sites in the US|An unblinded dose selection committee reviewed Part 1 results for the primary endpoint, total postsurgical opioid consumption, time to first opioid rescue, and safety data, and recommended a dose level and sample size for Part 2.
731686|NCT01683058|A multicenter, open-label, single-arm rollover trial designed to demonstrate the safety of aripiprazole intramuscular (IM) depot [400 or 300 milligrams (mg)] for the acute treatment of participants with schizophrenia, who met completion criteria in the registration trial NCT01663532. 74 participants were enrolled in this trial.|Participants entered this trial after completing the Week 12/Early Termination (ET) visit of trial NCT01663532 as it served as the Baseline evaluations for this trial.
731687|NCT01683019|Subjects were recruited at two separate psychiatric clinics. The recruitment period was between June 9, 2008 and November 5, 2008. Recruitment was accomplished through selection from the normal patient flow at the clinics.|Following enrollment and completion of informed consent, subjects were randomized to a treatment arm. Subjects were instructed to continue any concomitant medication throughout the treatment period. There was no wash out or transition required.
731688|NCT01682954||
731689|NCT01682928|Recruitment began April 8, 2012 and ended April 2014. Recruitment took place at Banner Good Samaritan hospital based on Banner IRB approval.|There were no pre-assignment events.
731690|NCT01682876|Subjects were enrolled at 22 locations|All enrolled subjects were included in the trial.
731691|NCT01682863|Patients were randomized to each treatment arm in 1:1:1 ratio.|Six hundred fifteen patients were randomized. One patient was randomized but did not receive treatment due to an adverse event. In the safety set, patients were analyzed according to the treatment received. Therefore, protocol enrollment and analysis set was 614 but the participant flow was 615
731692|NCT01682837||
731693|NCT01682759|In total, 1197 participants at 115 clinical sites were screened and 446 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were participants not meeting the metformin inclusion criteria or meeting exclusionary laboratory values.|
731694|NCT01682720|Participants were enrolled at a total of 77 study sites in Europe. The first participant was screened on 19 September 2012. The last participant observation occurred on 08 January 2014.|"475 participants were screened and 421 were randomized.
~419 participants were randomized and received at least 1 dose of study drug (Safety Analysis Set).
~334 participants with genotype 2 or 3 hepatitis C virus (HCV) infection were randomized and received at least 1 dose of sofosbuvir (Full Analysis Set)."
731695|NCT01682681||
731696|NCT01682642||
731697|NCT01682603|The chronic SCI patients with urinary incontinence in Hualien Tzu Chi General Hospital were consecutively recruited into this study.|Patients were excluded if they had an active urinary tract infection, urinary tract cancer, history of lower urinary tract surgery or chronic systemic diseases. If patients fulfilled the inclusion criteria, they were enrolled in this study.
731698|NCT01682538|First subject screened: 29 August 2012 Last subject last visit: 25 October 2012.|
731699|NCT01682512|Subjects were enrolled into this multi-center, randomized, double-blind, parallel arm, multiple dose, active comparator 2 part trial from 27 September 2017. Trial was terminated on 3 September 2015 and last subject completed 28 October 2016.|509 subjects were screened for eligibility to participate in the trial. 293 subjects met all inclusion and exclusion criteria and were randomised to receive treatment. 6 subjects were included in an open-label safety run-in prior to randomisation in Part-I.
731700|NCT01682460||
731701|NCT01682213||
731702|NCT01682148|From September 2012, subjects were recruited across 20 sites in four countries: Denmark (5 sites), Finland (2 sites), Norway (2 sites) and Sweden (11 sites). Due to slow recruitment, the study was terminated early.|272 subjects were planned to be randomised (136 subjects in each group). In total, 100 subjects were enrolled and 88 (44 subjects in each group) were randomised and received study medication; 12 subjects were screening failures.
731703|NCT01682135||Participant study completion is defined as a participant either completing all 6 cycles of study drug or discontinuing study drug due to dose-limiting toxicities (DLT), then completing all required End-of-Therapy and End-of-Study assessments.
731847|NCT01673126||
731704|NCT01682083|The study was conducted in 169 centers across 25 countries. Results reported have the data cut-off as of 30 June 2017.|Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIA (lymph node metastasis &gt;1 mm), IIIB, or IIIC] cutaneous melanoma.
731705|NCT01682044||
731706|NCT01682031||
731707|NCT01681992|US sub-cohort: Subjects recruited in US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with Varivax (VV), Havrix (HAV) and Prevnar 13 (PCV-13) at Day 0. Non-US sub-cohort: Subjects recruited outside US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with VV and HAV at Day 0.|4538 subjects were registered in the study. 3 subjects were excluded because of invalid Informed Consent Forms and 19 subjects received a subject number but were not vaccinated. Therefore, the number of subjects started is 4516.
731708|NCT01681849|Participants were recruited from the Emory Clinic and Emory University Hospitals from September 2006 to November 2013.|Of the 91 participants who were consented, 7 were excluded due to not meeting screening criteria.
731709|NCT01681836|Healthy adult participants were recruited between October 2012 and October 2013.|11 participants recruited; 11 screened; 0 excluded
731710|NCT01681810|Subjects 18-60 years with metabolic syndrome and hypertension were recruited through the University of Pittsburgh Research Participant Registry, University of Pittsburgh Nutrition and Obesity Research Center Registry, university and University of Pittsburgh Medical Center hospital electronic and paper advertising, and radio and bus advertising.|Twenty four age eligible subjects were consented and eligibility was confirmed. Four were excluded after eligibility confirmed due to poor IV access or not showing to baseline assessment visits, all prior to starting nitrite drug.
731711|NCT01681771|Recrutiment from medical clinics|No pre-assignment details to report
731712|NCT01681628|Public announcement throughout Kasese district of Uganda for those with symptoms of PTSD (described in announcement).|Participants had been previously identified. As an excess number presented, only sufficient for the trial were assigned. One participant was excluded as not meeting age criteria (had to be 18 years old or over).
731713|NCT01681589|The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.|
731714|NCT01681576|Period 1: 4 weeks treatment with LCZ696 400mg QD or Valsartan 320mg, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with Valsartan 320mg QD or LCZ696 400mg QD|
731715|NCT01681511|Single Site Recruitment|"As of Study Termination: 100 Sbj signed Informed Consent, 95 Sbj RND
~Definitions:
~Safety Pop=Any Sbj receiving treatment after RND
~Evaluable Pop=All RND Sbj successfully CZD ≥ 72±24 hours w/out systemic (post-op) antibiotic for CZD/non-CZD related reasons.
~CZD=catheterized or catheter, Pop=Population, RND=Randomized, Sbj=Subject"
731716|NCT01681472||
731717|NCT01681433||
731718|NCT01681368||
731719|NCT01681277||
731720|NCT01681212||A total of 21 participants were enrolled, and 15 received treatment.
731721|NCT01681186||This randomized single-dose study consisted of 2 parts. Part A had Cohorts 1 and 2 receive ascending doses of LY2940680 and placebo over 2 periods. Part B had Cohort 3 receive 1 of 2 treatment sequences over 4 separate periods to evaluate tablet versus capsule (reference) formulation, and the effects of food and proton pump inhibitor (PPI).
731722|NCT01681121||
731723|NCT01681095||
731724|NCT01681069||
731725|NCT01681030|Subjects were recruited from September 17, 2012 through September 3, 2013 at hospitals and medical centers throughout the United States.|
731726|NCT01681004||Of the 442 patients who were screened for participation at 19 sites, 159 (37.8%) were enrolled. Eleven subjects withdrew before treatment (1 before randomization and 10 after randomization but before any treatment was performed), yielding a total of 148 subjects who were enrolled, randomized and treated.
731727|NCT01680991||
731728|NCT01680965||
731729|NCT01680900||
731730|NCT01680887||
731731|NCT01680861||
731732|NCT01680848||
731733|NCT01680835||
731734|NCT01680783||
731735|NCT01680666||
731736|NCT01680653|Potential subjects were recruited from clinic; if more than 20 subjects were interested in participating in a given session, we preferentially enrolled those with a history of nocturnal awareness confirmed within the previous 2 months, (hypoglycemia unawareness confirmed with the Clarke screening test), or A1c <8% needing >0.7 units/kg day insulin.|
731737|NCT01680549||
731738|NCT01680497||
731739|NCT01680458||
731740|NCT01680341|The trial was conducted in 43 sites in 5 countries: Algeria (3 sites), Germany (5 sites), Malaysia (3 sites), Turkey (3 sites), and United States (29 sites).|While entering the treatment period the subjects discontinued insulin glargine (IGlar) and sulfonylurea (SU)/glinides (if administered) but continued treatment with up to 3 other oral antidiabetic drugs (OADs) as prescribed.
731741|NCT01680328|The trial was conducted at a single site in Germany at a single visit.|
731742|NCT01680172|Participants were recruited at Mayo Clinic in Scottsdale, Arizona from 2012 to 2014.|
731743|NCT01680159||Patients of Pustular Psoriasis and Psoriatic Erythroderma could directly receive doses of TA-650 10mg per 1kg not to go though screening period.
731744|NCT01680016|Subjects were enrolled at Mengshan CDC|All enrolled subjects were included in the trial
731745|NCT01679613||This was a randomised, open-label trial with a 2-way cross-over Pilot part, followed by a 2-way cross-over Main part. Subjects participated either in the Pilot part with 2 treatment sequences (A_B and B_A) or in the Main part with treatment sequences (C_D and D_C) with wash-out period of at least 14 days between each sequence.
731746|NCT01679600||6 subjects dropped out before assiggnment (abnormal gait pattern due to uncontrollable spasticity, tibia skin lesion due to inadequate padding during familiarization, lack of motivation to produce maximal work rate values, severe groin pain caused by the body weight support harness, suspected cerebrospinal fluid leak, acute respiratory infection)
731747|NCT01679405||
731748|NCT01679314||
731749|NCT01679301||
731750|NCT01679236||
731751|NCT01679197||
757935|NCT00186017||
757936|NCT00185965||
731756|NCT01678911||11 Subjects enrolled in the study and started a single-blind placebo lead-in period. Of those, 5 were randomized. 6 subjects did not continue and were either lost to follow-up, chose not to continue, or exhibited a large placebo response and no longer met the criteria to continue in the study.
731757|NCT01678898|Recruitment efforts were conducted in North and South America, Europe and Australia for PB-102-F01 (3 months), and all patients who completed this study continued to the PB-102-F02 extension study for an additional 9 months, to complete a total of 12 months of treatment. 18 patients were eligible for enrollment, and 16 completed the study.|Eighteen (18) patients were eligible for enrollment for PB-102-F01 study. The eligible patients who completed PB-102-F01, needed to sign an informed consent for PB-102-F02.
731758|NCT01678885||
731759|NCT01678846|Cross-sectional baseline and endline surveys were conducted in 42 schools in June/July 2012 and June/July 2014. A simple random sample of up to 130 P5, 6 and 7 students were invited for individual interviews. If there were fewer than 130 P5-7 students in a school, all were invited for interview.|
731760|NCT01678820||All participants randomized population.
731761|NCT01678807|Participants must have had a clinical history of allergic rhinitis/rhinoconjunctivitis (with or without asthma) to house dust of 6 months duration or more and had a positive skin prick test response to Dermatophagoides pteronyssinus or Dermatophagoides farina at the screening visit. Other inclusion and exclusion criteria applied.|
731762|NCT01678560||
731763|NCT01678443||
731764|NCT01678313|140 Patients with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and PSA>4 ng/dL underwent randomization 70 patients in study group 70 patients in control group|
731765|NCT01678209|Recruitment: 8/10/2012 - 4/30/17; Roll Over Year: 5/1/17 - 4/30/18; Youth with ADHD and Healthy Controls recruited from the community and clinics at Mount Sinai.|
731766|NCT01678196|Participants were partners of Veterans who had screened positive for PTSD or alcohol use disorders in prior surveys with the study team. Of 287 identified eligible partners, 190 were successfully reached and 66 consented to be in the study.|
731767|NCT01678144|"All patients were enrolled at Helsinki University Central Hospital from June 2011 to April 2014.
~During Stage 1 (2011-2012) and Stage 2 (2013-2016) MAR was implanted for 12 patients.
~11 of 24 consented patients did not receive MAR due to non-anatomical fit (majority in Stage 1); for 1 patient MAR was replaced before the operation was completed."|"Patients qualifying for mitral valve repair surgery according to guidelines from the European Society of Cardiology (ESC) and the American Heart Association (AHA) and meeting pre-operative selection criteria.
~Successful implantation rate improved significantly during Stage 2 after sizing adjustment of the implant (Regular and Expanded)."
731768|NCT01678131||
731769|NCT01677988||
731770|NCT01677936||51 total subjects were randomized. 5 were excluded (1 snack; 4 raisin) due to lack of post-randomization evaluable data. Thus, the full analysis data set included 27 raisin and 19 snack.
731771|NCT01677910|Participants took part in the study at 48 investigative sites in Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, and the United States from 08 January 2013 to 21 March 2016.|Patients with Carcinoid Syndrome not adequately controlled by somatostatin analog (SSA) therapy were assigned in a 1:1:1 ratio to receive placebo, 250 mg or 500 mg telotristat etiprate (LX1606) in the double-blind period and were eligible to receive 500 mg telotristat etiprate in the 36 week open-label extension. 136 randomized;1 patient twice.
731772|NCT01677858|This study was conducted at 32 centers in the United States. Participants were enrolled from September 2012 to September 2014.|In phase 1 participants were enrolled into 1 of 4 sequential dose-escalating cohorts to establish the maximum tolerated dose (MTD) of carfilzomib plus dexamethasone. In phase 2 participants were enrolled to evaluate the efficacy and safety of carfilzomib plus dexamethasone at the MTD established in phase 1.
731773|NCT01677767|A total of 127 participants were enrolled from 7 centers in India. This study was conducted between 14 April 2011 and 23 September 2013.|Out of 127 participants enrolled in the study, 1 participant was enrolled wrongly and data for 2 participants were not available at the study Centre. Therefore, 124 participants were evaluated in this study.
731774|NCT01677624||'Insufficient response' = Insuf Resp
731775|NCT01677507||"135 consented. Prior to baseline measures: 4 were excluded for ineligibility; 6 withdrew consent fully prior to baseline measurements.
~After baseline measures: an additional 2 were excluded based on physician decision, and 2 withdrew for participant decision.
~Thus, 121 participants are included for period 1."
731776|NCT01677377||This was an open-label, Phase 2A, multiple-ascending dose study performed at 2 sites in the U.S. Seventy subjects were screened and 45 subjects were enrolled and received RBP-7000.
731777|NCT01677312||
731778|NCT01677299||
731779|NCT01677286|Patients referred to an amyloidosis center and no longer requiring active treatment to control progressive disease were recruited to the study.|
731780|NCT01677195|Randomized, double blind, placebo controlled clinical trial of ACCS100 for the prevention of cancer associated with dietary Aflatoxin exposure. Recruitment occurred in Bexar and Medina Counties, Texas, USA from August 2012 through August 2014. The number of participants was 234 and 143 finished the study.|
731781|NCT01677182|Participants took part at 98 sites in Bulgaria, the Czech Republic, Germany, Great Britain, Poland, Romania, Russia, Serbia, Ukraine, and the United States from 29 August 2012 to 03 September 2014.|Participants with a historical diagnosis of bipolar 1 disorder were enrolled in 1 of 3 treatment groups as follows: placebo; TAK-375 0.1 milligram (mg); TAK-375 0.4 mg.
731782|NCT01676961||
731783|NCT01676909||262 participants were enrolled in the study prior to randomization. 20 participants were not able to be randomized due to attrition resulting in a final study sample of 242.
731784|NCT01676896||
731785|NCT01676831||
731786|NCT01676727||
731787|NCT01676714||
731788|NCT01676701||The study was to include a 12-week treatment period, optional 40-week safety extension, and post-treatment follow-up (at least 24 weeks). At the time of early study termination, all participants who had received tabalumab discontinued dosing and then completed the post-treatment follow-up period. No one entered the 40-week safety extension period.
731789|NCT01676532||
731848|NCT01673113||11 subjects were randomized to have either left or right flank treated. The untreated flank served as the internal control for each subject.
731792|NCT01676298|A total of 8 individuals were recruited for a company pool of known suspected genotypes; each with a different CYP2C19 genotype confirmed prior to the study by bi-directional sequencing.|Spartan Bioscience
731793|NCT01676220|A total of 1396 participants were screened, of whom 518 participants were screen failure and 878 participants were randomized.|
731794|NCT01676116|The trial was conducted at 81 sites in 5 countries as follows: Australia: 5 sites; France: 7 sites; Hungary: 4 sites; Slovakia 6 sites; United States: 59 sites.|The duration of the screening period was 2 weeks. All subjects continued GLP-1 receptor agonist and metformin±pioglitazone±SU treatments in their pre-trial doses during the screening period.
731795|NCT01676012||Bronchoscopy will be performed in a standardized order using five different imaging modes.
731796|NCT01675960||
731797|NCT01675830||
731798|NCT01675778|Participants were patients with acute pain recruited from the Emergency Department at Jacobi Medical Center|
731799|NCT01675765||
731800|NCT01675661|Recruitment occurred almost exclusively through advertising. Individuals currently in treatment for cannabis dependence were not eligible to participate|
731801|NCT01675635|This study is a randomized, double blind, double dummy, multicenter, parallel group, comparative study to compare the efficacy and safety of oxycodone capsule versus morphine tablet. The subject recruited from hospitalized patients poor with moderate to severe pain following surgery. The duration of the study from 2011 Jul to 2011 Dec.|"There is no run-in or wash out period involved in this study.
~On the protocol 240 subjects was planned to be enrolled, but actually 234 subjects was screened and all randomized. Zero screen failure is reasonable for the indication with this study design."
731802|NCT01675622|A total of 242 subjects were enrolled from 20 centers in which 192 subjects completed the study and 50 subjects did not completed the study. All the subjects were recruited from medical clinic.The recruitment period is from 2011 Jan to 2012 Mar.|Patients with moderate to severe cancer pain requiring oral opioid therapy were screened. All the patients who meets the inclusion/exclusion criteria were enrolled to double blind treatment phase. No wash our or run-in period required by protocol.
731803|NCT01675596||
731804|NCT01675544||
731805|NCT01675531|Safety set: 72 subjects ITT set: 66 subjects PP set: 41 subjects.|73 Patients was enrolled. However, 1 patient was not administered investigational drug. So the patient excluded from safety set.
731806|NCT01675492||
731807|NCT01675479||167 subjects were consented in the study, of which 69 subjects had one or both eyes treated for a total of 135 treated eyes.
731808|NCT01675453||
731809|NCT01675427||
731810|NCT01675297|medical clinic|wash out 7~14days
731811|NCT01675167||Of 1656 subjects screened, 938 subjects entered an analgesic taper phase and 1 subject was eligible to bypass the analgesic taper phase; a total of 815 subjects progressed to the open-label (OL) titration phase. Subjects who completed the open-label titration phase (511) were eligible for randomization in the double-blind (DB) treatment phase.
731812|NCT01675141||
731813|NCT01675128||
731814|NCT01675063||
731815|NCT01675050||
731816|NCT01675011||11 patients screened and 4 randomized.
731817|NCT01674725||
731818|NCT01674712||
731819|NCT01674647|The study was conducted at 141 centers (involving 144 investigators) in Europe, South Africa, North America, and Asia Pacific.|Overall, 1584 subjects were screened and 80 subjects did not complete or pass screening. 1504 subjects were randomized; 1002 were assigned to rivaroxaban and 502 to vitamin K antagonist (VKA).
731820|NCT01674634||
731821|NCT01674621||
731822|NCT01674569|Subjects with wet age related macular degeneration were enrolled at 5 US retinal clinics between November 2012 and March 2015|110 subjects were screened for entry into the study. 52 did not meet inclusion criteria, 19 declined to participate and 4 were excluded for other reasons
731823|NCT01674478||
731824|NCT01674062||A total of 99 participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer were screened for Cohorts 1 and 2, of whom 66 were recruited. Following primary analysis of Cohorts 1 and 2, a total of 51 new participants were screened for Cohort 3, of whom 29 were recruited.
731825|NCT01674010||
731826|NCT01673984|35 subjects screened and 27 subjects were enrolled. Following enrollment, 21 patients were randomised before the study was prematurely discontinued.|
731827|NCT01673919|A total of seven participants who completed the core study WA19977 were enrolled in this extension study conducted from 13 February 2012 to 15 January 2014 at four centers in France.|
731828|NCT01673893||
731829|NCT01673867||A total of 792 participants enrolled in the study; 582 were randomized. Of the 210 participants not randomized, 4 experienced an adverse event (AE), 24 withdrew consent, 5 died, 1 was lost to follow-up, 163 no longer met study criteria, 1 was removed by sponsor for administrative reasons, and 12 were removed for other reasons. Study is ongoing.
731830|NCT01673854||A total of 70 patients were enrolled, and 46 received treatment.
731831|NCT01673828||
731832|NCT01673802||
731833|NCT01673698||
731834|NCT01673646|30 patients were planned and 33 patients were enrolled. The full analysis sets (FAS) consisted of 33 patients (11 patients per dose group).|
731835|NCT01673620||
731836|NCT01673594||
731837|NCT01673568||
731838|NCT01673490||Eligible participants with benign prostatic hyperplasia (BPH) entered into a 6-month enrollment period followed by a6-month treatment period and a one-month follow-up period. The total duration of the study was 13 months.
731839|NCT01673425||
731840|NCT01673386|All screening assessments were performed within 28 days prior to the first dose of study drug. All subjects were recruited as per the inclusion and exclusion criteria.|
731841|NCT01673373||
731842|NCT01673347||
731843|NCT01673282|This study started to enroll subjects in Austria and Germany in July 2012 and concluded in July 2015.|The Participant Flow consists of subjects in the Safety Set (SS) which received at least 1 dose of VIMPAT. Of the 315 enrolled subjects 311 were included in the SS.
731844|NCT01673256||
731845|NCT01673191||
731846|NCT01673178||
731849|NCT01673061|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
731850|NCT01673022||
731851|NCT01673009||
731852|NCT01672996||
731853|NCT01672983||
731854|NCT01672970||
731855|NCT01672957||If Informed Consent Form (ICF) was signed after the transplantation, it was considered as a major protocol violation and reported separately from protocol violation in Participant Flow.
731856|NCT01672892||
731857|NCT01672879|Participants were enrolled at study sites in Europe and North America. The first participant was screened on 29 October 2012. The last study visit occurred on 03 January 2017.|453 participants were screened.
731858|NCT01672866|Participants were enrolled at study sites in Europe and North America. The first participant was screened on 05 December 2012. The last study visit occurred on 29 December 2016.|631 participants were screened.
731859|NCT01672853|Participants were enrolled at study sites in North America and Europe. The first participant was screened on 4 March 2013. The last study visit occurred on 24 August 2016.|298 participants were screened.
731860|NCT01672827|This study examined brain PET scans from 276 subjects previously acquired form various GE Healthcare studies (GE-067. The study did not enroll the blinded image Readers.|
731861|NCT01672801||
731862|NCT01672788||This was an open-label, randomized, 4-way crossover trial. 36 patients were randomised to one of 4 treatment sequences and treated. Each treatment period consisted of a single dose of medication followed by 72 hours of pharmacokinetic sampling, with a washout of at least 7 days between treatment periods.
731863|NCT01672736|Subject enrollment under this IND was stopped prematurely due to the drug manufacturer's decision to terminate the development of the study drug, Linsitinib (letter dated 1 November 2015). Therefore, the study did not proceed to Phase II portion of the study protocol. The available study drug supply at the study sites expired on 31 May 2016.|
731864|NCT01672723|Participants were recruited from the UCLA community and surrounding areas and were run between December 2012 and February 2014.|50 screened, 19 excluded (1 asked to be removed, 15 did not respond to additional scheduling requests or additional requests for information for the lab task, 3 reported stomach discomfort at a severe level and were removed).
731865|NCT01672710||
731866|NCT01672658||
731867|NCT01672294|The study conducted recruitment from June 2013 to October 2015. Potential patients were identified by data pulls and then medical record review as well as obtaining approval to approach from providers. Patients were approached both at select outpatient clinics at the Durham VAMC as well as being sent invitation letters with subsequent phone calls.|Participant pairs (seriously-ill veteran and primary informal caregiver) were consented and then each completed a baseline interview before the dyad was randomized. Enrolled participants may be excluded if either of the pair refused to consent or did not complete a baseline.
731868|NCT01672242|Normal subjects were recruited from the University of Maryland School of Medicine|Volunteers were asked briefly about their health status and given spirometry to document no evidence of obstructive airways disease or other chronic lung disease that would impact their FRC measurements with high flow nasal cannula therapy or CPAP.
731869|NCT01671839||
731870|NCT01671748|Study procedures took place in a single dedicated unit specialising in wound healing research, between August 2012 and November 2013.|All enrolled patients received 4 weeks of SOC prior to random allocation (run-in phase). Patients whose wounds reduced by >40% in the first 4 weeks were withdrawn and did not progress to random allocation.
731871|NCT01671605||
731872|NCT01671488||
731873|NCT01671345|Eligible patients (active diagnosis of type 2 diabetes mellitus and a hemoglobin A1c ≥ 7.5) were identified and recruited from the Primary Care clinic and Women's clinics at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago. Recruitment period lasted from 11/27/13 to 11/30/16.|794 patients were screened; 625 were excluded (not meeting inclusion criteria -188, declined participation/did not respond to invite - 437). 169 patients were enrolled.
731874|NCT01671332|Recruitment occurred from June 2012 through April 2014.|
731875|NCT01671319|The study was performed through the Wisconsin Oncology Network, a regional oncology network, at a combination of academic and community practice sites. Patients were enrolled between June 2011 and June 2012.|
731876|NCT01671293||
731877|NCT01671280||
731878|NCT01671176||
731879|NCT01671111||A total of 30 participants were enrolled to this open-label extension study (24 participants transferred directly from feeder studies SPD602-201 [NCT01186419], SPD602-202 [NCT01363908], and SPD602-203 [NCT01604941] and 6 participants did not transfer directly and received a chelator other than SSP-004184 after discontinuation from a feeder study).
731880|NCT01671085||Participants who discontinued from the study prior to completion were permitted to be replaced.
731881|NCT01671059||
731882|NCT01671007|This study investigated characteristics of patients with non-valvular atrial fibrillation influencing the choice of antithrombotic treatment for the prevention of stroke, and the safety and effectiveness of dabigatran versus Vitamin K Antagonist for up to 3-year follow-up period.|All subjects were screened for eligibility prior to participation in the study. Subjects attended a participating site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
731883|NCT01670825||
731884|NCT01670760||
731885|NCT01670721|The study was conducted at 38 sites in France. A total of 182 participants were screened between 08 August 2012 and 30 June 2014, out of which 175 participants were enrolled and treated.|Participants enrolled in the study to assess the safety of Aflibercept in participants treated with a combination of Aflibercept with FOLFIRI regimen (Irinotecan, Leucovorin and 5-Fluorouracil [5-FU]).
731886|NCT01670656||
731887|NCT01670526||
731888|NCT01670500|The trial was conducted at 13 academic centers and participants were recruited from these locations. Accrual occurred between January 2012 and January 2019.|
731889|NCT01670487||
731890|NCT01670292||
731977|NCT01664806|40 patients were recruited at the University of Colorado Hospital.|Two screened patients were excluded because they refused entry into the trial.
731891|NCT01670279|This was a phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose trial planned in 3 sequential cohorts of elderly participants (70 to 85 years old) with major depressive disorder (MDD). Brexpiprazole was administered as an adjunct treatment to the current antidepressant therapy that the participant received.|The study included a 30-day screening period, a 14-day washout period, up to 45-day inpatient treatment period (titration: received brexpiprazole or placebo once daily [QD] for 14 or 21 days and fixed dose phase: received assigned fixed dose for 14 or 28 days), and a 30-day follow-up after the last dose of study drug.
731892|NCT01670201||
731893|NCT01670188|Patients requiring placement of a peripherally inserted central catheter (PICC) line in the neuroscience intensive care unit were recruited at Mayo Clinic in Rochester, Minnesota.|One patient randomized to the non-SCD arm died before the first ultrasound could be obtained and therefore could not be entered into the analysis.
731894|NCT01670110||
731895|NCT01670045||
731896|NCT01670019||
731897|NCT01669902||
731898|NCT01669863|6 patients recruited as planned|
731899|NCT01669811|First subject enrolled on 25 August 2012. Last subject completed on 30 May 2014.|Out of 1398 enrolled subjects, 287 subjects were randomised and 1111 subjects were not randomised. The reasons of no randomisation were 'Eligibilty criteria not met' (1067 subjects), 'Subject decision' (37 subjects), 'Adverse event' (2 subjects) and other reasons (5 subjects).
731900|NCT01669798|Patients were enrolled from February of 2013 to July of 2017 at three cancer clinics in North Carolina and Virginia.|
731901|NCT01669785||
731902|NCT01669720||
731903|NCT01669642|children between 2-18 years of age who presented to st louis children's hospital emergency department between april 2012 and august 2014 with a fracture that needed reduction or a skin abscess that needed drainage under sedation were approached for enrollment.|
731904|NCT01669629||There were 183 subjects enrolled with 183 subjects randomized.
731905|NCT01669603||789 subjects were screened for participation. 190 subjects met all study criteria for randomization to study intervention.
731906|NCT01669577|"334 patients were collected during São Paulo rescue system activities. Entry criteria was defined as hypotensive patients (SBP<90mmHg at the scene, high-energy traumas, severe TBI); patients under 18 years old were excluded.
~If calculated ISS < 16 or no informed consent, patients were excluded."|Pre assignment were not performed, as patients were not known.
731907|NCT01669538||Of the 98 subjects who enrolled in the study, 16 were deemed ineligible to participate and therefore not assigned to a treatment arm (i.e., did not Start the study). Thus, 82 subjects Started the study.
731908|NCT01669434||
731909|NCT01669421||
731910|NCT01669174||
731911|NCT01669148||"496 enrolled and 426 completed study, but no information available to distinguish study arms:
~Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number of participants enrolled in arm is unknown).
~Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number of participants enrolled in arm is unknown)."
731912|NCT01669122|Participants were recruited at the clinical site.|A total of 102 participants were screened, of which only 40 were randomized into the study. Fourteen participants did not meet the study criteria, 32 were lost to follow up, 2 withdrew consent while remaining 14 were not randomized due to other reasons.
731913|NCT01669096||
731914|NCT01668966||
731915|NCT01668940||
731916|NCT01668836||
731917|NCT01668797|A total of 753 participants were screened at 49 trial sites in the following 7 countries: United States (US, including Puerto Rico), Malaysia, Colombia, Romania, Ukraine, Serbia, and Turkey.|Trial had Phase A (Conversion) (N= 406), Phase B (Oral Stabilization) (N= 464; 346 rolled over from Phase A and 118 entered directly into Phase B ) and Phase C (Double-Blind Maintenance) with (N= 202 rolled over from Phase B). Participants were randomized in to Phase C in a 1:1 ratio (brexpiprazole:placebo) to receive treatment for up to 52 weeks.
731918|NCT01668784||1054 participants enrolled, 821 participants randomized (410 nivolumab, 411 everolimus). Reasons for non-randomization include 9 participants had adverse events, 15 participants withdrew consent, 2 participants died, 1 participant lost to follow-up, 193 participants no longer met study criteria, and 13 participants for other non-listed reasons.
731919|NCT01668667||
731920|NCT01668654|Participants (par.) aged 12 years or older, who had participated in a previous parent study GSK113284 (NCT014945840) evaluating Retigabine/Ezogabine in the treatment of partial onset seizures or seizures comprising Lennox-Gastaut syndrome, were enrolled in this open-label extension study.|Eligible par. began the Treatment Period at the eligibility assessment Visit followed by a 3-week Taper Phase, and a Follow-Up Visit within 3 days from the end of the Taper Phase. The study was prematurely discontinued after enrolling only 4 of the planned 500 par.
731921|NCT01668628|"Date of the recruitment period : From October 10, 2010 to April 3, 2013
~Types of location : At the general hospitals"|
731922|NCT01668589|The study was conducted at various study centers in Germany, Austria, Greece, and Belgium. The recruitment period was from 28 November 2012 to 31 August 2013.|
731923|NCT01668537||
731924|NCT01668355||
731925|NCT01668173||
731926|NCT01668147||
731927|NCT01668030|Patients were recruited from hospital burn unit.|
731928|NCT01668017|First/last subject (informed consent): September 2012/April 2015. Last subject completed: April 2015.|This study was to be conducted in 2 parts; Part 1 was the dose escalation phase and Part 2 was the expansion phase. However, due to early termination of the study, the sponsor decided not to conduct the expansion phase (Part 2).
731929|NCT01668004||A total of 104 participants were screened; 3 participants were screen failures who did not enroll.
731930|NCT01667978||
731931|NCT01667926|Outpatients were recruited primarily through referrals.|
731932|NCT01667900||
731978|NCT01664793||
731979|NCT01664741||102 of the participants who passed the on-phone screen came in and signed the consent form to be enrolled in the study. Baseline characteristics data was collected from them but they however failed an assessment done prior to getting the PET scan and so could not start the study.
732522|NCT01629784|Adult subjects with cutaneous lupus erythematosus (CLE) were recruited from Northwestern University's dermatology and rheumatology clinics.|
731933|NCT01667848|Approval from the local institutional ethics committee was obtained on June 2011. Between July 1st, 2011 and December 28nd, 2013, a total of 148 patients were scheduled for laparoscopic cholecystectomy at the General Hospital in Linz, Austria|Patients converted intraoperative to open cholecystectomy or those undergoing a concomitant procedure were excluded from the study. Irregularities of the study protocol (absence of rectal probe, missing consent form, conversion to open cholecystectomy) entailed in exclusion of the study. Patients with acute cholecystitis were excluded of the study.
731934|NCT01667796||
731935|NCT01667731|Participants were enrolled at a total of 34 study sites in the United States. The first participant was screened on 20 July 2012. The last participant observation occurred on 10 February 2014.|330 participants were screened.
731936|NCT01667679||A total of 334 participants were assessed for eligibility; of these, 275 participants were randomized.
731937|NCT01667562||375 participants were in the diagnostic population. Out of the 375 participants, only 30 participants had EGFR mutation and were eligible for erlotinib treatment.
731938|NCT01667549|Pregnant women or newly parturient women who intended to breastfeed their infants exclusively for at least 4 months were recruited from ads in local newspapers, websites, and Philadelphia Women, Infants, and Children (WIC) offices. We enroll mother -infant dyads because both members of the dyads were tested.|No mother-infant dyads were excluded from the study prior to assignment to groups.
731939|NCT01667536||
731940|NCT01667471||
731941|NCT01667432||
731942|NCT01667419||
731943|NCT01667250||
731944|NCT01667224|The study subjects were recruited from Clinical Trial Center for Functional Food in Chonbuk National University Hospital during the 2009. Only those subjects who were obese[both BMI≥25kg/m2 and WHR≥0.90(men), WHR≥0.85(women)] and were not diagnosed with any disease were included in this study.|Among the 105 subjets screened, 25 subjects had anthropometric and/or laboratory tests results that were in the exclusion criteria category, hence they were excluded from the study.
731945|NCT01667107||
731946|NCT01667029||
731947|NCT01666951||
731948|NCT01666912||
731949|NCT01666782||105 patients were enrolled but only 100 had evaluable data. 4 patients received a vaccination both in years 1 and 2 of the study- only year 1 results were included in the analysis. 1 additional patient was excluded from the efficacy analysis when it was revealed he had received a second vaccination in the same season.
731950|NCT01666652|This study enrolled healthy male and non-pregnant, non-breast-feeding, female subjects between the ages of 18 and 39 (inclusive). Subjects were enrolled at the CTC, WRAIR, Silver Spring, Maryland, US. Subjects were not screened for prior flavivirus infection.|
731951|NCT01666444|Enrollment was initiated on 2012-Aug-13 and terminated on 2014-Apr-11. During this time, 297 patients were enrolled.|Prior to enrollment and treatment assignment, a completed eligibility checklist was electronically checked for completeness and compliance with eligibility criteria. Prior to treatment assignment, patients were stratified by prior platinum free interval (<6 months or >6-12 months) and performance status (0 or 1). Treatments were double-blinded.
731952|NCT01666314|Participants took part in the study at 43 investigative sites in Japan, United States, Greece, Australia, Netherlands, Ireland and United Kingdom from 20 August 2012 to 01 September 2016.|Male participants with a diagnosis of adenocarcinoma of the prostate were enrolled in the study. In Japan, participants were randomized to 200 mg orteronel, Placebo, 300 mg orteronel, or Placebo, BID, in a ratio of 2:1:2:1; ex-Japan participants were randomized to 200 mg orteronel, Placebo, 400 mg orteronel, or Placebo, BID, in a ratio of 2:1:2:1.
731953|NCT01666210||
731954|NCT01666197|Four centers in Germany recruited patients from 22 Aug 2012 to 27 Jan 2013|
731955|NCT01666145||
731956|NCT01666119||
731957|NCT01666002|We enrolled adults (18-75 years) with a clinical diagnosis of onychomycosis from the dermatology clinic at Stanford between July and December 2011. The key inclusion criterion was a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture.|Patients were randomized following simple randomization procedures (computerized random number generator) in a 2:1 ratio into laser or control groups.
731958|NCT01665950||
731959|NCT01665911||
731960|NCT01665872|Participants were screened throughout the community with a needs assessment during the time frame 05/21/2012 through 06/02/2016.|
731961|NCT01665807|Sites: 2 acute care hospitals in Canada Dates: September 25, 2012 to November 20, 2012|"People who had self-administered intradermal influenza vaccine in past were only eligible for the repeat self-administration arm.
~No other pre-assignment eligibility criteria."
731962|NCT01665768||7 participants were screen failures.
731963|NCT01665599|Subjects were recruited from 19 study centers (17 in the US and 2 in Canada).|Of the 656 screened subjects, 180 subjects were enrolled into the study.
731964|NCT01665508||
731965|NCT01665430|The study included participants with early, moderate to severe rheumatoid arthritis (RA) who had completed WA19926 (NCT01007435) core study and who may have benefited from tocilizumab treatment based on the Investigator's judgment.|43 participants were initially screened but only 38 participants were enrolled, and started the study.
731966|NCT01665170|Individuals will be recruited via newspaper, mailing lists and radio advertisement in the area of Trier,Germany by DAaCRO. Recruiting: May 2012 - July 2012 in medical center/ CRO for Trier Social Sress Tests.|Three subjects were not included because the recruitment phase was already completed.
731967|NCT01665157|Recruitment period: 14 months Recruitment location: GI outpatient clinic|
731968|NCT01665144||During the core, eligible patients were randomized in a 2:1 ratio to siponimod (BAF312) or placebo.
731969|NCT01665092||
731970|NCT01665053|"A total of 1684 patients have been enrolled in the study Evolve II Randomizes Clinical trial (RCT) from 26 November 2012 until 29 Aug 2013.
~The Evolve II RCT study is anticipated to be completed (final 5-year follow-up) in 2018."|
731971|NCT01665040||
731972|NCT01664975||
731973|NCT01664949||
731974|NCT01664923||
731975|NCT01664897|Recruitment Period: May 2013 to May 2014|
731976|NCT01664858||
732012|NCT01663012||
732523|NCT01629771||
757937|NCT00185900||
731980|NCT01664624|Participants took part in the study at 2 investigative sites in the United States from 10 July 2012 to 29 November 2012.|Participants with a diagnosis of type 2 diabetes mellitus and inadequate glycemic control were enrolled equally in 1 of 4 treatment groups, roflumilast + alogliptin, alogliptin alone, roflumilast alone, or exenatide.
731981|NCT01664559||
731982|NCT01664533|Total of 59 patients were screened at 17 specialist oncology and pneumology centers in Belgium, 57 of which started Tarceva therapy as second-line treatment and constitute safety analysis (SA) population. Three patients violated the protocol, leaving 54 patients in the per-protocol (PP) population.|
731983|NCT01664494|A total of 563 participants were included from April 2010 to July 2012 at 21 sites in Austria.|Of 563 participants, 220 were treated for adjuvant colon cancer, 200 were treated for metastatic colorectal cancer, 84 were treated for metastatic breast cancer, and 59 were treated for advanced gastric cancer.
731984|NCT01664247|The trial was conducted at 129 sites in 11 countries randomised subjects: Canada (7), France (10), Germany (8), Israel (6), Italy (7), Serbia (7), South Africa (6), Ukraine (4), United Arab Emirates (3), United Kingdom (6), and United States (65).|
731985|NCT01664130|Subjects were recruited from regional hospitals from July 2012 thru Jan 2015.|
731986|NCT01664117|A total of 210 participants were enrolled from 38 rheumatology units in Spain. This study was conducted between June 2012 and June 2013.|Of 210 participants, one participant was excluded from the study because of past history of biologic disease-modifying antirheumatic drug (bDMARD) monotherapy under 6 months. Therefore, 209 participants were evaluated in this study.
731987|NCT01664104||A total of 151 participants were enrolled in the study; of which,136 participants met the eligibility criteria. The results are reported only for those participants who met the eligibility criteria.
731988|NCT01664091|Participants enrolled from September 2009 through September 2012.|
731989|NCT01664078||
731990|NCT01664052|66 participants were enrolled in two centers.|
731991|NCT01664039|Subjects were recruited from 2 study centers located in Slovenia.|All enrolled subjects were randomized. This reporting group includes all randomized subjects (104). Note: 1 subject randomized to Travatan and 3 subjects randomized to Lumigan did not receive treatment.
731992|NCT01663987||Randomized, placebo-controlled, double blind, parallel group design involving an event-driven treatment period up to the close of the study and a minimum 30-day follow-up period up to the close of the study
731993|NCT01663935||
731994|NCT01663922|All volunteers were recruited at a single centre, SSAT Research Unit, Chelsea & Westminster Hospital, London, UK.|"Eligible participants took:
~SJW for 14 days Group A D1-D14 or boceprevir(BCP) for 5 D10-D14 days Group B (D 10-14); PK profile on D14 then 7 day washout period to D21 D22-D35, all took SJW (+ BCP on D31-D35); PK on D35 then washout to D42 Group A took BCP on D52-D56; Group B SJW on D43-D56; PK profile on D56."
731995|NCT01663896|Initially a total of 1069 subjects gave consent from 36 investigational sites, of which 418 qualified subjects completed enrollment in February 2014 at 35 investigational sites. First subject was enrolled on Dec 11, 2012 and the last subject completed the 12 month follow-up on Mar 12, 2015.|Of the 1069 subjects, 616 were failed to screen and 35 were not qualified for inclusion. Thus 418 subjects underwent pre-intervention fractional flow reserve (FFR) and optical coherence tomography (OCT), percutaneous coronary intervention (PCI), and post intervention FFR and OCT. The subjects were followed up through 12 month post stent implant.
731996|NCT01663857||Participants in Phase 1b are considered to have completed the study if they experience a dose-limiting toxicity or completed the Pharmacokinetic (PK) sampling set. Participants in Phase 2 are considered to have completed if they die due to any cause or who are alive and on study at conclusion, but are off treatment.
731997|NCT01663779||
731998|NCT01663740||
731999|NCT01663727||
732000|NCT01663714||Participants (par.) received cyclophosphamide (C), vincristine (V), prednisone (P) in the first study phase (P). Upon completion of this P, par. began the first of 2 phases of radio immunotherapy: P1, dosimetric dose (DD); P2, therapeutic dose. Par. completing 2 years of the study could enter a long-term follow-up study (BEX104528; NCT00240578).
732001|NCT01663636|Parents of infants between the ages of 8 and 14 weeks presenting for the first dose of the 3-dose infant primary immunization series were eligible if they owned a mobile phone with SMS text messaging capability and were recruited in 2 pubic health clinics in Guatemala City from April to May of 2013.|At least one parent had to be literate and able to use SMS technology. Parents were excluded if they were under 18 years of age or if their child had a contraindication to vaccination. Allocation to SMS vaccine (intervention) or usual care (control) was done using a computer generated randomization.
732002|NCT01663623|Participants with diagnosis of Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) were randomized in this study. The study was conducted at 37 centers in 15 countries in North America, Central America, South America, Western Europe, Eastern Europe, and Australia during 20 March 2013 - 06 February 2017.|A total of 164 participants were screened and 106 were enrolled and randomized in a 1:1 ratio to receive placebo or belimumab 10 milligram per kilogram (mg/kg). Of which, 105 received at least 1 dose of study agent and one participant was randomized in error.
732003|NCT01663532|The trial was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of aripiprazole IM (intramuscular) depot as treatment for an acute episode of schizophrenia in adult participants. The trial was conducted in 55 sites.|This trial included a 13-Day Screening phase (which includes Washout from previous antipsychotics for 7 days and/or washout from other prohibited medications), a 12-Week acute treatment phase, and a 14 (±2) Day safety follow-up.
732004|NCT01663506||
732005|NCT01663402|The study was conducted at 1387 sites in 57 countries. Of these, 1328 active sites randomized at least 1 participant. Overall, 35,437 participants were screened between 11 October 2012 and 17 Jan 2017; of whom 16,513 were screen failures. Screen failures were mainly due to exclusion criteria met.|Randomization was stratified according to country. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1 ratio (alirocumab: placebo), with permuted-block randomization.
732006|NCT01663363|334 eyes were treated among 170 participants.|
732007|NCT01663285||
732008|NCT01663272||
732009|NCT01663259||43 patients consented, but one never began treatment.
732010|NCT01663233||
732011|NCT01663103||
732013|NCT01662999|20 August 2012 to 29 November 2012. Phase 1 Clinical Pharmacology center with healthy, fasted participants.|89 participants enrolled; 42 randomized and treated with study drug. 47 not randomized for following reasons: 3 withdrew consent, 38 no longer met study criteria, 6 had other reasons. Treatment was administered on Day 1 of each period after fast of 10 hours; Washout began after single dose in the period and was for at least 6 days.
732014|NCT01662986||Randomized, placebo-controlled, double blind, parallel group design involving an event-driven treatment period up to the close of the study and a minimum 30-day follow-up period up to the close of the study
732015|NCT01662960||
732016|NCT01662908|From September 2012 through January 2014, a total of 85 patients were enrolled at 26 centers in North America (US and Canada). One subject was not included in either the full analysis set or the safety analysis set because of major protocol violation - he did not take any dose of study drug.|
732017|NCT01662895||
732018|NCT01662882||
732019|NCT01662856||
732020|NCT01662791|Subjects were recruited at the Mayo Clinic in Scottsdale, Arizona.|
732021|NCT01662778||
732022|NCT01662765||
732023|NCT01662752||
732024|NCT01662648||
732025|NCT01662635|The recruitment began on February 01, 2011 and finished on September 01, 2014. All samples were obtained at the Instituto Nacional de Cancerología, in Mexico.|Samples were sent to the unit of Anatomic Pathology, where a pathologist confirmed the histologic diagnosis. The only inclusion criterion was the availability of tissue for biomarker studies.
732026|NCT01662583||
732027|NCT01662531|Of the 18 sites that were activated, subjects were enrolled from 17 sites in 10 countries.|Subjects <12 years of age with severe hemophilia B (FIX activity of ≤2%) were planned to be enrolled in the study, including 11 to 12 subjects in each age group (6 to <12 years and <6 years of age). Of 29 subjects screened, 27 subjects were enrolled and treated with rIX-FP.
732028|NCT01662505||Patients with written informed consent underwent screening within (≤) 14 days before starting the volasertib treatment. Eligible patients were enrolled and treated as soon as possible or within (≤)14 days after obtaining informed consent.
732029|NCT01662492||
732030|NCT01662440|Subjects were enrolled from five sites in Germany, one site in Austria, and one site in Switzerland.|All subjects were included in the trial.
732031|NCT01662362||
732032|NCT01662336|Patients were recruited from the practices of 8 physicians in Canada between 29 June 2012 and 06 August 2015.|
732033|NCT01662310||
732034|NCT01662297||
732035|NCT01662115||
732036|NCT01662102||
732037|NCT01662063||
732038|NCT01662024||
732039|NCT01661972||
732040|NCT01661946||
732041|NCT01661933|Of 20 potential candidates, 2 could not be contacted (address changed), 1 was not interested, and 5 were unavailable (travel-2, pregnancy-2 or study-1 commitments). Twelve enrolled in September 2012. 8 committed to 3 endoscopic procedures and 2 committed to two endoscopies.|
732042|NCT01661881|Patients enrolled from August 2012 through March 2014.|
732043|NCT01661790||
732044|NCT01661764||
732045|NCT01661712|This is a randomised, sham-controlled crossover trial using transcutaneous electrical stimulation of the upper airway dilator muscles in patients with confirmed obstructive sleep apnea (OSA).|A total of 390 patients were assessed, 44 patients were screened. 8 patients were excluded as screening failures. 36 patients were randomised into the sequence 'Sham Stimulation, then True Stimulation' (n=18) or 'True Stimulation, then Sham Stimulation' (n-18). All 36 randomised subjects completed the trial, serving as their own control.
732046|NCT01661686||
732047|NCT01661621||
732048|NCT01661595|Participants were recruited from the community via flyers and local postings.|30 subjects enrolled in this study. 6 subjects failed the screening and were withdrawn. 6 subjects chose to withdraw participation before the study began. 18 subjects began the study. 2 subjects were withdrawn during the study. 16 subjects completed the study.
732049|NCT01661283||
732050|NCT01661270|The study was conducted at 37 centers in 5 countries. A total of 332 participants were randomized between 17 July 2012 and 18 March 2014.|"Due to treatment kit misallocation, part of the patients randomized to placebo received aflibercept for
~1/several treatment cycles and are presented as a separate group for safety evaluation.
~EOT criteria were: disease progression/death, un-tolerable toxicity, consent withdrawal/Investigator decision."
732051|NCT01661205|First subject treated on September 11, 2012. A total of 31 subjects consented from 6 sites (4 USA and 2 Europe). One subject was exited from the study prior to intervention and was re-consented. Only 30 unique subjects were enrolled in the study. Twenty-six subjects treated from 5 sites.|Five consented subjects were withdrew prior to treatment. Three did not meet the eligibility criteria, 1 subject was withdrawn by the investigator, and 1 subject withdrew consent.
732052|NCT01661179|From 12 November 2012 to 18 June 2013, 14 participants were treated by 4 centers in Japan to receive vandetanib.|16 participants were screened; 14 participants were treated.
732053|NCT01661140||The initial open label period of the study consisted of one group of 427 participants. After completion of the initial phase only participants, who achieved a good/moderate disease response, were randomized into the double blind period. 272 participants were randomized into the two arms entering the double-blind period of the study.
732054|NCT01661114||
732055|NCT01661088||
732056|NCT01661062||
732057|NCT01660906||39 participants enrolled and were treated.
732058|NCT01660893||
732059|NCT01660815||
732060|NCT01660802||
732061|NCT01660763|Recruitment period of 9 months - August 2012 through April 2013|"Patients were excluded per protocol exclusion criteria at Screening as well as post surgery for certain conditions including the following:
~Patients who were not awake or stable
~Patients with arterial oxygen saturation that couldn't be maintained at 95% or greater
~Patients with uncontrollable vomiting"
732062|NCT01660737||
732140|NCT01654796||Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data. Adverse events are reported for all 85 subjects.
732567|NCT01626989||
732063|NCT01660698|Recruitment at the Metabolic Unit, (study no. 11.03.MET, NCT01660698) during the Grass Pollen (GP) season. Twenty seven adults volunteered, of which twenty four who gave written informed consent were screened for clinical history of allergy to GP > 2 years and a confirmatory skin prick test (SPT) to GP. Twenty subjects were randomized.|Subjects assigned to either: probiotic or placebo groups and taking assigned product for 8 weeks with three visits: V1(at baseline), V2 (4 weeks after treatment) and V3 (8 weeks after treatment).
732064|NCT01660672||
732065|NCT01660451|"Part A-Study enrolled participants from 41 study centers in 10 countries, between 19 NOV 2012 (first participant first visit [FPFV]) and 01 OCT 2015 (cut-off date for interim analysis).
~Part B-Study enrolled participants from 81 study centers in 24 countries, between 04 NOV 2013 (FPFV) and 22 JUN 2016 (cut-off date for primary analysis)."|"Part A: Overall 125 participants were screened, of them 41 were screen failure. Total 84 were assigned to treatment.
~Part B: Overall 213 participants were screened, of them 70 were screen failure. Total 143 were assigned to treatment, of them 1 was suspected as fraudulent and excluded from analysis sets. Therefore 142 participants were evaluable."
732066|NCT01660412||Each Participant received four injections. We tested four different injection sites. Each participant received all four injections at one site.
732067|NCT01660334||
732068|NCT01660321|Overall Study|
732069|NCT01660230||
732070|NCT01660191||
732071|NCT01660022|Date of first enrolment: 11SEP2012 Date last volunteer completed: 07MAY2013 Phase 1 Clinical Research Unit|
732072|NCT01659996|Participants were enrolled from 24 July 2012 to 14 June 2013 in 62 clinical centers in the United States.|A total of 1394 participants were enrolled for the study, data on 1288 participants who met all the inclusion and none of the exclusion criteria and who completed the vaccination schedule are presented in this report.
732073|NCT01659866||563 patients consented and of these, 53 were excluded as follows: 16 patients had issues with informed consent, 20 received antimicrobials off protocol, 16 did not undergo TRUSP and 1 was lost to follow up. Thus 510 patients underwent swabs; 430 had CS isolates while 80 had CR isolates. All 510 patients completed the study.
732074|NCT01659853||
732075|NCT01659736||
732076|NCT01659567||
732077|NCT01659554|Subjects were screened and enrolled during 10/23/2012 to 08/20/2013.|
732078|NCT01659320||
732079|NCT01659268|"The strategy of data collect were Workshop Airway management in emergencies: use of laryngeal mask which dates of realization 21/11/2012 to 24/11/2012. The disclosure of event were e-mail, site of the institution and posters. Students entries were made through electronic."|The activities were described for the students in the arrive to the workshop.
732080|NCT01659125||
732081|NCT01659021|Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 04 December 2012. The last study visit occurred on 15 August 2018.|310 participants were screened.
732082|NCT01658943||
732083|NCT01658904||The study did not progress to the phase II portion. The study was closed prematurely because the investigator left the National Institutes of Health.
732084|NCT01658839|Participants were recruited from 4 investigational centers located in the US, 1 located in France, 1 located in Spain, and 1 located in Saudi Arabia.|Twenty-five participants were enrolled and completed the study. This reporting group includes all enrolled participants (25).
732085|NCT01658813||
732086|NCT01658735||
732087|NCT01658657||
732088|NCT01658579||A total of 85 participants were screened, of whom 26 participants were screen failures and 59 participants were randomized. The data for outcome measures was planned to be reported for combined reporting arms (HOE901-U300 Combined and Lantus Combined).
732089|NCT01658514||
732090|NCT01658436|"This was a Phase II, two-stage, multicenter study, where Stage 1 was a singlearm,open label design and Stage 2 was planned to be a randomized, double-blind study.
~However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated."|Initially , the patients were started at BEZ235 400mg bid dose regimen. The preliminary safety & tolerability data fro first 3 patients treated at this dose showed all patients reported AEs leading to dose interruption. It was decided to decrease the dose of BEZ235 to 300mg bid dose regimen.
732091|NCT01658228|Patients were recruited from clinics and/or advertisements.|86 subjects were enrolled in the open treatment phase of the study and then 61 subjects were randomized at 16 weeks to the add-on donepezil/placebo treatment groups.
732092|NCT01658150||
732093|NCT01658072||
732094|NCT01658059||
732095|NCT01658020||
732096|NCT01657903|Participants were recruited at the clinical site.|
732097|NCT01657877|Participants were recruited at one clinical site (US).|A total of 95 participants were screened, of which 79 were randomized. Of the subjects who were not randomized, 11 did not meet the study criteria; 3 had protocol violations; 2 withdrew consent.
732098|NCT01657799|Participants were enrolled across 87 sites in Argentina, Australia, Belgium, Canada, Chile, Czech Republic, Egypt, Finland, France, Hungary, Korea, Norway, Russia, Spain, Taiwan, Ukraine, and the United States.|Subjects were randomized in a 1:1:1 ratio to one of three treatment groups. Randomization was stratified by graded prognostic assessment (GPA) score (≤ 2.5 versus > 2.5) and neurological symptoms (symptomatic versus asymptomatic).
732099|NCT01657760|Alcohol-dependent (AD) and healthy control (HC) participants were screened via the SCID-IV, excluding any participants with any Axis I psychiatric diagnosis within the last 6 months (aside from and alcohol dependence in the AD group). Fourteen potential AD and seventeen potential HC participants were enrolled and screened.|Enrolled participants who did not start study procedures either decided not to participate or failed screening.
732100|NCT01657617|Participants were recruited in the oncology clinics at the University of Kentucky between 2007 and 2014|
732101|NCT01657461||
732102|NCT01657370||
732103|NCT01657344|All participating sites' IRBs have granted a waiver of informed consent and assent for this study. In addition, all participating sites' IRBs have a granted a waiver of written authorization for HIPAA. Patients will not be approached for recruitment.|
732568|NCT01626820||At least 50% of the subjects in Fluviral Adults and Fluviral Elderly Groups had not been previously immunized with influenza vaccine in the 2011/2012 season.
732569|NCT01626690||
732104|NCT01657305|Study participants were enrolled from 03 Aug 2012 to 01 Aug 2013 in 18 clinical centers in 6 countries: Germany (8 centers), Czech Republic (2 centers), Poland (1 center), Finland (1 center), Austria (2 centers), and Bulgaria (4 centers).|111 participants were screened and wound halves of 107 participants were randomized and treated. For four screened participants, wound halves were neither randomized nor treated with study medication for the following reasons: not randomized by mistake, violation of inclusion criteria, surgery cancelled, and withdrawal of consent.
732105|NCT01657292|Study participants were enrolled from 31-Aug-2012 to 10-Jul-2013, in 10 clinical centres in 4 countries: Germany (4 centers), Uk (3 centers), Sweden (2 centers), and Switzerland (1 center).|66 patients were screened of which 5 violated eligibility criteria and thus 61 subjects were treated.
732106|NCT01657266|160 subjects were recruited, 12 of whom were excluded, 10 because they did not meet the selection criteria and 2 refused to participate. The remaining 148 were randomly assigned to one of the 2 study groups, 73 to bromfenac and 75 to napaphenac.|
732107|NCT01657253|"Recruitment period started since february 2014 to january 2015. sites of research: Private Medical Office, Ophthalmology Hospitals (nationals and internationals)
~Patients with:
~mild to moderate Dry eye
~age > 18 year old
~OSDI between 12 and 45
~TBUT ≤ 10 seconds
~Schirmer test ≤ 10mm"|183 patients were enrolled at baseline, however, only 148 ended the period of intervention and 35 were excluded or deleted by different reasons.
732108|NCT01657162|Eligible participants who received abaloparatide or placebo in the double-blind study (BA058-05-003 [Study 003]), were enrolled to this open-label extension study. Complete results for Study 003 are reported in the ClinicalTrials.gov Study Record NCT02653417.|The procedures performed for the Follow-up visit (Month 19) for Study 003 served as Baseline for Day 1 of Study BA058-05-005 (Study 005).
732109|NCT01657032||
732110|NCT01657019|This was an open-label extension study to evaluate the long-term safety of SPD489 in adults aged 18-55 years with binge eating disorder (BED) who completed 1 of 3 antecedent studies, all of which tested SPD489 for BED (SPD489-208, SPD489-343, or SPD489-344).|
732111|NCT01656967||
732112|NCT01656889|Subjects were screened at 43 sites in the US and 5 in Canada; between August 22, 2012 and April 18, 2014; sites included independent and hospital wound clinics and private practice sites.|Subjects entered a 2-week run-in; subjects whose wound radius decreased by < 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization. After completion of the treatment period, subjects entered a three-month follow up period.
732113|NCT01656850||
732114|NCT01656772||
732115|NCT01656759||Prior to randomization, 21 patients were disqualified for protocol violation.
732116|NCT01656733|Participants were recruited beginning August 20, 2012. Enrollment sites included Hartford Hospital (Hartford, CT) and Baystate Medical Center (Springfield, MA).|154 participants gave written consent for study participation and 137 were randomized. Therefore, 17 participants were excluded for the following reasons: no show after screen (10), high PHQ9 (2), moved out of area (2), current drug use (1), advanced gestational age (1), and stress too high to continue (1).
732117|NCT01656629||
732118|NCT01656486||
732119|NCT01656460||
732120|NCT01656434||
732121|NCT01656408||
732122|NCT01656395||Out of 576 randomized participants, 557 received treatment. The planned MK-1029 1 or 3 mg arm and the Montelukast + MK-1029 arm did not enroll any participants.
732123|NCT01656304||
732124|NCT01656252|Study closed after phase I. Phase II study was not conducted.|One patient did not start treatment because of an infection before starting protocol treatment.
732125|NCT01656200||
732126|NCT01656187|73 patients were screened for eligibility between May 2012 and January 2016.|46 of 73 participants were randomized. Of those not randomized, 27 did not meet inclusion criteria.
732127|NCT01656161|Participants took part in the study at 10 hospital settings in South Africa, from 03 July 2012 to 30 August 2013.|
732128|NCT01656031|Recruiment began 02/28/2005 and ended 08/06/2008.|
732129|NCT01655901|Randomized crossover study (1 group doing all 3 conditions). Wash-out period of 1 week between conditions.|
732130|NCT01655823||
732131|NCT01655719||
732132|NCT01655563||22 participants were excluded after enrollment due to the following reasons: 8 developed ineligibility criteria for randomization, 2 withdrew, 4 were delisted for transplant, 4 died and 4 had still not received a transplant.
732133|NCT01655498|Participants were recruited primarily through Investigators' private practices with some additional participants recruited through IRB approved advertisements between 14 Aug 2012 through Nov. 2013.|"200 subjects were consented:
~Pre-fitting screen fails: vaginal anatomical exclusions (13), logistics issues (12), LTFU (5), other (16).
~Baseline diary screen fails: (44).
~Post-fitting screen fails: unsatisfactory fit (28), unable to manage device (4), LTFU (1), logistics issues (2), withdrawal (14)."
732134|NCT01655381||A total 15 participants who completed the Week 104 visit of the WA19926 core study, were enrolled in this follow-up open-label extension study.
732135|NCT01655329|Ten Board Certified radiologists practicing in community (non-university) practice were recruited from the Washington, DC, - Baltimore, MD, Metropolitan region. Recruitment was by email and phone calls to prior participants in our studies and to other radiologists that they referred us to. Recruitment April, 2012 through September, 2012|54 cases were used to train the radiologists on the use of the data recording computer and to make them familiar with the appearance of the processed chest radiographs. These cases were not used in the test of reader performance.
732136|NCT01655069|Participants recruited for this study were children (5 to less than 12 years old) and adolescents (12 to less than 18 years old) with overactive bladder (OAB), who completed the 2-week placebo run-in period and 12-week treatment period of Study 905-CL-076 (NCT01565707).|Children and adolescents with OAB, who completed study 905-CL-076, consented to enter this study and fulfilled all the eligibility criteria were enrolled at Week 12/13 (2-3 days after last dose was received during the 905-CL-076 study). The age of participant at informed consent signing in 905-CL-076 determined the age group in this study.
732137|NCT01655043||
732138|NCT01654887|Participants with suspected pneumonia in an emergency department were recruited from the Pediatric Emergency Department at Mount Sinai Hospital.|
732139|NCT01654861||
732570|NCT01626664||
732571|NCT01626495||
732141|NCT01654666|Symptomatic and asymptomatic subjects with carotid artery stenosis which was more than 70% by angiography , duplex ultrasound, Computed Tomography Angiography or Magnetic Resonance Angiography (NASCET criteria), who could undergo carotid artery stenting and all follow-ups, were recruited starting from August 2012.|
732142|NCT01654601|Participants recruited from a specialty clinic at s hospital, in Seoul, Naju, Chungju, Iksan and Kyungju, Korea between June 2012 and March 2013|32 participantsrecruited : 28 screened, 4 excluded(3 did not meet inclusion criteria and 1 refused participation)
732143|NCT01654549||
732144|NCT01654536||
732145|NCT01654523|33 people were consented and interviewed for participation; 20 met study criteria and agreed to continued with the project.|
732146|NCT01654445|Patients were recruited from July 2012 through July 2014|All patients were treated with study drug.
732147|NCT01654380||
732148|NCT01654315||
732149|NCT01654302||
732150|NCT01654289|Participants recruited from the greater Madison WI (USA) community between July 2012 and September 2016.|Prospective subjects were met in person for informed consent and enrollment in a 2-week run-in trial. Run-in tasks included baseline questionnaires, at least one phone contact, self-report questionnaires at home, and a follow-up in-person appointment. Successful completion of run-in activities allowed participants to enroll in main study.
732151|NCT01654276||
732152|NCT01654263|Participants were healthy adult males and females, 55 through 74 years of age, recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 10OCT2012 and 03MAR2015.|
732153|NCT01654250|Total 90 participants were enrolled in this study, out of which 86 participants were randomized.|The study consisted of an open-label (OL) dose-optimization phase (1 to 6 weeks), and a placebo-controlled, double blind (DB) for 1 week with no dose adjustments.
732154|NCT01654224|Participants were enrolled during the 2011-2012 and 2012-2013 influenza seasons|A total of 205 participants from 15 community-based LTCFs who met all inclusion and none of the exclusion criteria were enrolled.
732155|NCT01654107||
732156|NCT01654068||
732157|NCT01653964||83 subjects were enrolled (consented) but 1 subject was found not to meet eligibility criteria, so did not participate in the study.
732158|NCT01653912|Subjects were enrolled at 10 centers in 3 countries (United Kingdom, Australia, and Russia)|As described in Statistical Analysis Plan (SAP) dated 14-Jul-2015, as there were <10 subjects in Cohort B (n=2), data was summarized in phase 2 total column but not presented in a separate column for Cohort B.
732159|NCT01653782|Recruitment details: period sept 2010-dec 2011, invited to examination at a University clinic. 1st questionnaire ÖMSPQ to screen for risk level, 2nd extensive questionnaire covering multi aspects of back pain,3rd examination by a back specialist, 4th blinded randomisation to allocate to group, 5th information on allocation and evidence based advice|"exclusion: n 12 due to: below 90 on OMSPQ, comorbidities affecting ability to physical activity, not skilled in Swedish language, sick leave exceeding 2 weeks, red flags"
732160|NCT01653743||
732161|NCT01653704|All emergency medicine residents in postgraduate years 1-5 in both the Royal College of Physicians and Surgeons and College of Family Physician programs at the University of Ottawa were invited to participate in the study.|
732162|NCT01653587||
732163|NCT01653509|Participants were recruited at the clinical site.|105 screened, 60 underwent ultraviolet (UV) rays induction, 25 developed a cold sore and were randomized into the study.
732164|NCT01653418|The study opened to participant enrollment on 09/20/2012 and closed to participant enrollment on 06/18/2013.|
732165|NCT01653405||
732166|NCT01653327|Participant recruitment occurred between 5/24/2010-8/3/2016.|Participants were randomized to receive ketamine (K) or placebo (P) in repeating sequences of KPK or PKP. Not all participants completed all sequences. A participant was considered complete if they received at least one dose of K or P and completed the pain assessment.
732167|NCT01653288||
732168|NCT01653262|This study started to enroll subjects in July 2012. In Oct 2013, the Sponsor evaluated the study in light of the recruitment rate. Given the unanticipated lack of recruitment during the prior 8 weeks, a decision was made to stop recruitment as of 16 Oct 2013.|Participant Flow refers to the Enrolled Set. In total, 32 subjects were screened and 29 subjects were enrolled instead of 30 subjects as per protocol amendment 2. This difference was considered as insignificant and not affecting the planned analysis.
732169|NCT01653210||
732170|NCT01653158||
732171|NCT01653132|Subjects with Parkinson's disease/ parkinsonism with troublesome sialorrhea were recruited from the Movement Disorders clinic at Beth Israel Deaconess Medical Center, Boston, and by providing information to neurologists around the Boston area. Ten subjects were recruited between 9/5/2012 and 2/26/2014. The last study visit was completed on 9/5/14|17 subjects were assessed; 7 were excluded because they did not meet study criteria. This was a cross over study; all subjects received both placebo and Incobotulinum toxin injections and were followed up for 3 months after each injection. Washout period was 1-2 months, saliva weight had to be ≥ (baseline- 0.5 SD), to receive the second injection
732172|NCT01653028|From August 2012 to April 2014, a total of 72 patients were accrued to this study (Cohort 1 - 12, Cohort 2 - 10, Cohort 3 - 11, Cohort 4 - 10 Cohort 5 - 29) at a rate of 4.5 patients per month.|
732173|NCT01652976||
732174|NCT01652885||
732175|NCT01652872|Anemic participants with chronic kidney disease and not on dialysis (CKD-ND) were enrolled at 126 study centers in the United States, from 30 July 2012 to 19 October 2017. The on-study duration was approximately 2 years, comprising of a 2- to 4-week screening period, a 96-week treatment period and a 4-week follow up period.|Participants were randomized in a 1:1 ratio to 1 of 2 darbepoetin alfa dosing strategies (hemoglobin [Hb]-based titration group or fixed dose group). Randomization was stratified by red blood cell (RBC) transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).
732176|NCT01652729||Subjects were randomly assigned across 3 treatment groups (exenatide, sitagliptin, and placebo) in a ratio of 3:2:1, with randomization stratified by screening HbA1c stratum (< 9% or 9%).
732716|NCT01615822||
732717|NCT01615809||
732718|NCT01615731||
754276|NCT00437125||167 participants were screened and 16 participants were screen failures
732177|NCT01652716||Subjects were randomized across two treatment groups (exenatide once weekly and exenatide twice daily) in a ratio of 3:2 with randomization stratified by diabetes management method at screening, screening haemoglobin A1c (HbA1c) stratum and renal function.
732178|NCT01652703|"Japanese men or women ≥ 20 to ≤ 80 years of age and who were at high risk for cardiovascular events, on a stable dose of an approved statin (with or without ezetimibe) and fasting low-density lipoprotein cholesterol (LDL-C) ≥ 115 mg/dL.
~First patient enrolled on 10 July 2012; last patient enrolled 19 February 2013."|"Randomization was stratified by screening LDL-C level (< 130 mg/dL [3.4 mmol/L] vs
~≥ 130 mg/dL) and by diagnosis of heterozygous familial hypercholesterolemia (HeFH) (yes vs no)."
732179|NCT01652690|"The study was conducted at various study centers in the Czech Republic and Slovakia.
~The recruitment period was from 26 June 2012 to 15 May 2013."|
732180|NCT01652664|Participants were recruited from 38 investigational centers in the United States, Germany, Singapore, United Kingdom, Taiwan, Philippines, Spain, Saudi Arabia, Colombia, France, Portugal, Belgium, Poland, Romania, Puerto Rico, and Mexico.|Of the 184 enrolled, 32 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (152).
732181|NCT01652573|Subjects were recruited from the individual practices of two of the physicians on this study and from a panel of patients with XLH who had previously participated or inquired about participation in ongoing clinical trials at this institution.|Patients who were receiving conventional therapy with calcitriol and phosphorus at the time of screening were asked to stop both agents two weeks prior to enrolling in the study and no subjects took calcitriol or phosphorus during the entire study.
732182|NCT01652534||There was a total of 3 participants enrolled into the study. All 3 participants were randomized to receive either Amantadine or Placebo and crossed over after a washout period.
732183|NCT01652495||
732184|NCT01652469|"Discrepancy between nb of enrolled pts and nb of pts who started treatment,because 1 patient,who shouldn't have been included (exclusion criteria),was enrolled in the database by mistake.In the database patient's status couldn't be changed from Enrolled to Ineligible,thus this patient considered enrolled,but was not included in efficacy cohort."|
732185|NCT01652287||
732186|NCT01652040||
732187|NCT01652001||
732188|NCT01651949||
732189|NCT01651936|This trial was conducted at 53 clinical centers in the United States, Australia, Columbia, Denmark, France, Greece, Hungary, Italy, New Zealand, Poland, South Africa, Spain, and in the United Kingdom. A total of 120 participants were screened and 56 were enrolled.|
732190|NCT01651806||
732191|NCT01651793|"Potential participants were recruited from (i) large university classes, (ii) announcements on buses, bulletin boards, and electronic listservs, and (iii) through word of mouth. Potential participants were invited to complete screening questionnaires (medical history, diet, mood) administered online using Zoomerang
~>http://www.zoomerang.com/<."|
732192|NCT01651780||
732193|NCT01651442||
732194|NCT01651403|Participants were enrolled at study sites in the United States, Asia, and Europe.The first participant was screened on 06 December 2012. The last Week 144 study visit occurred on 13 June 2019.|176 participants were screened.
732195|NCT01651351|Recruitment was conducted in the U.S at 1 study site. The first participant was enrolled in July 2012.|Thirty five healthy potential participants were enrolled at the clinical study site. Four were screen failures, and one was a back up participant who did not participate. Therefore, 30 participants were randomized.
732196|NCT01651260|Subjects were recruited between July 2012 to February 2013 in the ICU setting at 6 hospitals.|
732197|NCT01651208||
732198|NCT01651117||
732199|NCT01651104|Subjects were enrolled at one study center in Belgium.|All enrolled subjects were included in the trial.
732200|NCT01651078|"Forty-four (44) patients were enrolled between October 2012 and December 2015 across six centers in the United States (per the protocol, LAASR enrolled all patients who were scheduled to undergo a NeuroBlate procedure). Forty-two (42) patients underwent the procedure and were followed under the protocol as the NeuroBlate Procedure treatment arm."|
732201|NCT01651052||133 Subjects were enrolled and implanted with the study valve, for which data is available.
732202|NCT01651039|Recruitment began in July 2012 with enrollment from Sept 2012 to August 2015. 41 subjects signed consent (7 screened failed, 32 received study treatment, 5 non-evaluables). 27 out of the 32 subjects are evaluable.|
732203|NCT01651000|This multicenter study was conducted at 44 investigational sites within the US. Subjects were enrolled and treated from 07 September 2012 through 20 July 2014.|Subjects were stratified by CKD stage and were randomized in a 2:1 ratio to receive a daily 30 μg oral dose of CTAP101 capsules (or matching placebo) for 12 weeks at bedtime. Subjects presenting on a regimen of bone metabolism therapy were to discontinue their prior treatment for at least 28 days' washout (except for bisphosphonates).
732204|NCT01650844||
732205|NCT01650831|Adult subjects with suspected infection of Helicobacter Pylori due to symptoms were offered to do the test on a walk- in basis were recruited. 113 Subjects were recruited in October and November 2012 in a private medical clinic.|Subjects with prior knowledge of Helicobacter Pylori infection or taking proton pump inhibitors within the two week period before the test, were not included.Only one test per subject was done.
732206|NCT01650805||A total of 307 subjects were enrolled (ponatinib patients: 155; imatinib patients: 152). Patients were randomized in a 1:1 fashion to receive either ponatinib or imatinib.
732207|NCT01650779|The study was conducted at 6 centers in the United States of America between April 30, 2012 and March 15, 2013.|A total of 16 participants were screened of which 1 participant was screen failure. A total of 15 participants were enrolled in this study.
732208|NCT01650636|Chronic Fatigue Syndrome (CFS) and their partners were recruited from CFS physicians clinics and community.|
732209|NCT01650584|There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total).|
732210|NCT01650545||
732211|NCT01650519||
732212|NCT01650402||
732213|NCT01650350||
732214|NCT01650324||
732215|NCT01650298||
732216|NCT01650285||
738934|NCT01233869||172 participants were enrolled in this study, of which 169 received at least 1 dose of study treatment.
732217|NCT01650259|In this post marketing surveillance (PMS) study 4876 patients were registered: 2513 patients (Pts.) in Trazenta® Tablets group & 2363 patients in other Oral Antidiabetic Drug (OAD) group (grp). 2414 out of 2513 patients were treated (trt) with Trazenta® Tablets. For other OAD group only baseline data & no observation period.|Non-interventional,observational prospective study based on newly collected data under routine medical practice with 1 grp of Pts. treated with long-term daily use of Trazenta® Tablets for evaluation of baseline,safety& efficacy data & another grp of Pts. treated with any other oral antidiabetic monotherapy for collection of baseline data only.
732218|NCT01650246||
732219|NCT01650194|All participants in this all male study were enrolled at 1 site in the United States (US).|All eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled. A total of 64 participants were screened for eligibility.
732220|NCT01649947|Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. The study was open to accrual on 12/23/2011 and closed to accrual on 06/30/2015.|We are reporting results on 32 eligible patients. Seven patients were deemed ineligible.
732221|NCT01649856||A total of 662 individuals were screened for entry into the study, and 86 failed the screening procedure. Overall, 576 participants were randomized; 572 received treatment and were included in the analyses.
732222|NCT01649804||
732223|NCT01649791||
732224|NCT01649765|A total of 93 pediatric participants with Systemic Lupus Erythematosus (SLE) were enrolled at 29 study centers in 10 different countries. This was a multi-center study to evaluate the safety, efficacy and pharmacokinetics of belimumab plus background standard therapy. The results presented are based on Part A (double blind).|The study consisted of three separate phases: Randomized, placebo-controlled, double-blind 52-week treatment phase (Part A), Long term belimumab open label safety follow up for participants who completed Part A (Part B) and Long term safety follow-up phase for participants who were withdrawn from Part A or Part B at any time (Part C).
732225|NCT01649609||
732226|NCT01649596|Inpatients having surgery between September 1, 2012 through April 9, 2013.|Patients presenting with emergencies or with trauma were excluded.
732227|NCT01649557|The protocol was initially approved as a 6-week trial and later extended to a 52-week trial (Amendment 2). The trial enrolled 244 participants at 73 sites in 12 countries. Of the 244 participants, 28 were included in the 52-week enrollment population.|Trial consisted of a screening visit, treatment phase and safety follow-up at 30 (± 2) days after the last dose of medication. Eligible participants for the trial were those who completed protocol NCT00905307 and who in the investigators judgment would benefit from the treatment.
732228|NCT01649505||
732229|NCT01649427|81 patients were randomized, but only 73 were assigned drug. 1 patient who was excluded from efficacy analyses, was randomized to Prograf but did not receive treatment but kept for safety reporting. 74 patients were used for safety analysis while only 73 were available for efficacy analysis|"This is a 2-phase study:
~PHASE I:
~In 1st phase of study, PK parameters were evaluated in total of 60 evaluable patients (30 patients per treatment group)
~Phase II was not conducted"
732230|NCT01649375||
732231|NCT01649362||
732232|NCT01649297||
732233|NCT01649271|HER2: Human Epidermal Growth Factor Receptor 2; RECIST,v1.1: Response Evaluation Criteria In Solid Tumors, version 1.1|Phase Ia: Open label, uncontrolled, dose escalation study of afatinib given continuously in combination with trastuzumab administered every 3 weeks. Phase Ib: Open label, uncontrolled study to explore the efficacy, safety, pharmacokinetics & biomarkers of afatinib at the MTD dosage, with 3- weekly trastuzumab.
732234|NCT01649232|Subjects were screened and enrolled at 3 clinics in Spain|
732235|NCT01649180||
732236|NCT01648959||
732237|NCT01648920||
732238|NCT01648790||Participants were to be given 5 single doses of prasugrel in 5 different sequences on each of 5 consecutive mornings of treatment.
732239|NCT01648764||Participant Flow is reporting discontinuation from study drug. Completed participants were all those who completed Cycle 1.
732240|NCT01648699||
732241|NCT01648582||This was a parallel-arm, non-inferiority study. Study treatment continued for up to 52 weeks and participants were randomized in a 1:1:1 ratio to one of the 3 treatment arms: 1.5 milligrams (mg) dulaglutide once-weekly , 0.75 mg dulaglutide once-weekly, or insulin glargine once-daily.
732242|NCT01648530||This study was an internet survey to identify participants with Episodic Migraine (EM) and Chronic Migraine (CM). The participants were followed for up to 1 year by assessments every 3 months.
732243|NCT01648491||
732244|NCT01648452||
732245|NCT01648348||
732246|NCT01648322||
732247|NCT01648296||
732248|NCT01648283|11 subject withdrawals following consent due to personal reasons and/or conflicts, 3 subjects not evaluable, 64 subjects evaluable and included in analysis|
732249|NCT01648270||
732250|NCT01648166||
732251|NCT01648140|This study was conducted across 29 centers in 6 countries (United States, Puerto Rico, Germany, Belgium, France, and Bulgaria) from 15 August 2012 to 16 July 2014.|Participants with treatment-naïve(TN) chronic genotype1(G1) hepatitis C virus (HCV) infection were randomly allocated on 2:2:1 basis to 2 dose levels of GSK2336805 or telaprevir. In a nonrandomized single-arm cohort, participants with TN genotype4(G4) chronic HCV infection were enrolled in parallel at dose level of 60 milligrams (mg) of GSK2336805.
732252|NCT01648101|Participants with drug-resistant partial-onset seizures (POS) who were taking 1, 2, or 3 antiepileptic drugs (AEDs) with or without vagus nerve stimulator (VNS); had a 28-day total POS frequency rate >=4 seizures; and did not have a period of >=21 consecutive days without a POS over the 8-week Baseline Phase were enrolled in this study.|76 participants (par.) were randomized to study treatment; 75 par. comprised the Intent-to-Treat Population (par. who were randomly assigned to treatment, received >=1 dose/any portion of a dose of study medication, had Baseline [BL] seizure data, and had >=1 post-BL seizure record between the Titration Phase and the end of the Maintenance Phase).
732294|NCT01644643|A total of 333 patients were randomized in 53 centers in 16 countries: 306 patients had complicated urinary tract infection (cUTI) and 27 patients had complicated intra-abdominal infection (cIAI). The first patient was randomized on 07JAN2013 and the last patient was randomized on 29AUG2014. One patient in CAZ-AVI arm didn't receive study drug.|
754277|NCT00437073||
732253|NCT01647958|Patients were recruited from seven U.S. hospitals.|65 patients randomized: 41 treatment, 24 control. 39 and 21 respectively, were completed. Control-arm patients offered Crossover to TIF following 6 mo. follow-up visit. 21 control-arm patients crossed over to TIF procedure after 6-month follow-up. Note: 6 mo. difference between Crossover and Treatment patient post-hoc results. Extended Results Phase (3 and 5yr follow-up) participants are placed in a single cohort of Treatment + Control arm patients.
732254|NCT01647945||
732255|NCT01647737|Potential candidates were identified from a pool of previously diagnosed subjects and new subjects referred to the Clinical Center for Oral Medicine, School of Dentistry, Georgia Regents University|Subjects had a diagnosis of Xerostomia
732256|NCT01647711||Afatinib was administered until disease progression, however patients experiencing clinical benefit were allowed to continue treatment for as long as judged beneficial by the investigator.
732257|NCT01647581|11,182 enrolled into the study, but 10,084 screen failures as the majority did not have a polyp 1cm in size to meet criteria for randomization|Must have polyp 1cm in size removed during colonoscopy
732258|NCT01647542|Participants took part in the study at 59 investigative sites in Australia, China, the Republic of Korea, New Zealand and Taiwan from 30 July 2012 to 18 March 2014.|Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM) who were inadequately controlled when treated with only diet, exercise and any antidiabetic agent for less than or equal to (<=) 7 days within 12 weeks prior to Screening, were enrolled in 1 of 3 treatment groups: placebo; fasiglifam 25 milligram (mg); fasiglifam 50 mg.
732259|NCT01647516|Participants were enrolled at 57 sites from 13 countries located in Europe, North America, and the Asia-Pacific region.|Participants were randomly assigned in a 1:1:1 ratio on Day 1 to placebo, ozanimod 0.5 mg, or ozanimod 1 mg capsules and were stratified by whether they had received anti-tumor necrosis factor class of therapy (yes vs no).
732260|NCT01647464||
732261|NCT01647438|Community outreach|
732262|NCT01647282||
732263|NCT01647217||
732264|NCT01646827|This report presents results of a study on 37 adults with schizophrenia, conducted at 6 centers in the United States.|Participants were randomized 1:1 to receive a single dose of aripiprazole intramuscular (IM) depot (400 mg) in either the deltoid muscle or gluteal muscle according to the randomization schedule.
732265|NCT01646814||
732266|NCT01646762||
732267|NCT01646671||
732268|NCT01646645||
732269|NCT01646398||
732270|NCT01646385||
732271|NCT01646346|54 people were recruited to take part, however only 46 of those were treated and included in the study.|
732272|NCT01646320|Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial with Dapagliflozin added to Saxagliptin in Combination with Metformin compared to placebo added to Saxagliptin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Saxagliptin|"Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR
~Arm 2: Placebo + Saxagliptin + Metformin IR"
732273|NCT01646268|The SP0914 study began recruitment in July 2012 and concluded in May 2014. All subjects were recruited in China.|The Participant Flow and Demographics data is taken from the Randomized Set (RS). The RS includes all subjects that were randomized.
732274|NCT01646255|This multicenter, randomized, double-blind, parallel-group, placebo-controlled study started recruiting in August 2012.|Participant Flow refers to the Safety Set (SS), consisting of all randomized subjects who received at least 1 dose of study medication.
732275|NCT01646216|All subjects recruited were 6 months or more post stroke. During 2012-2016 recruitment was done by the following means: Subjects were referred by local physicians and recruited from databases of previous studies. Flyers were disseminated locally. Presentations were made at local stroke support groups.|Subjects were enrolled and randomly assigned to either Split or Tied treadmill training groups.
732276|NCT01646203||Participants that completed Cohort 1A, Cohort 1B or Cohort 2 are those who died, had progressive disease (PD) or off treatment & censored due to study completion.
732277|NCT01646177||This study has 4 periods: Period 1 - Screening; Period 2 - Blinded Induction Dosing Period (Weeks 0 to 12); Period 3 - Long-Term Extension Period (Weeks 12 to 264); Period 4 - Post-Treatment Follow-Up Period (Minimum of 12 Weeks)
732278|NCT01646151||
732279|NCT01646138||49 participants were enrolled but 1 participant did not receive the intervention.
732280|NCT01646125|Patients were randomized in a ratio of 1:1 to receive either AUY922 or pemetrexed/docetaxel. A total of 59 participants were randomized in the study: 31 to the AUY922 arm and 28 to the chemotherapy arm. 2 patients from the AUY922 arm & 5 from the chemotherapy arm were not treated. Only 52 received at least 1 dose of study medication.|
732281|NCT01646073||Participants were randomized at Week 0 (Day 1) in a 4:1 ratio to receive either adalimumab every other week (eow) or matching placebo.
732282|NCT01646021||139 participants were randomized and treated in the ibrutinib arm and 141 participants were randomized to the temsirolimus arm.
732283|NCT01645930|Participants took part in the study at 8 investigative sites in Singapore, Hong Kong and South Korea from 17 December 2012 to 11 April 2017. Data cut-off for the analysis was 14 July 2014.|Asian participants with a diagnosis of relapsed and/or refractory multiple myeloma were enrolled and received a combination of ixazomib, lenalidomide and dexamethasone.
732284|NCT01645735||
732285|NCT01645709||
732286|NCT01645280||A total of 274 subjects were enrolled into the study and 273 were treated. One participant in the Ustekinumab 90 milligram (mg) every 8 weeks group did not receive the treatment due to an adverse event before dosing.
732287|NCT01645176|Responders to ad in local paper, medical clinic May 2012 - Dec 2014|Osteoarthritis of knee
732288|NCT01645111||
732289|NCT01645098||
732290|NCT01645059|First Patient included: 28th july 2011 Last Patient included: 27 th march 2013 Location: outpatient department|
732291|NCT01644890|This study was conducted from September 2012 to January 2016 in three asian countries (Japan, Korea, Taiwan).|
732292|NCT01644734||46 patients were not documented to be treated with the study drug.
732293|NCT01644695||
732436|NCT01636102|Subjects were enrolled at 1 site in Belgium.|All subjects enrolled were included in the trial.
732437|NCT01636076||
732438|NCT01636063||
732295|NCT01644617|Participants must have had a clinical history of allergic rhinitis/rhinoconjunctivitis (with or without asthma) to house dust of 1 year duration or more and determined to be sensitized to Dermatophagoides pteronyssinus and/or Dermatophagoides farina by skin prick test and immunoglobulin E levels. Other inclusion and exclusion criteria applied.|
732296|NCT01644565|57 subjects were enrolled. An additional 2 subjects per cohort for Cohorts A-C and 2 subjects per group in Cohort D were included as alternates.|
732297|NCT01644500||
732298|NCT01644474|The study was conducted at 8 centers in 4 countries. A total of 204 participants were screened between July 2012 and November 2012, 101 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.|Randomization was stratified according to the diabetes mellitus status. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1 ratio ( alirocumab:ezetimibe) after confirmation of selection criteria. 103 participants were randomized.
732299|NCT01644396||
732300|NCT01644331||
732301|NCT01644292||
732302|NCT01644240||
732303|NCT01644188|The study was conducted at 126 centers in 10 countries. Overall, 1112 participants were screened between August 2012 and May 2013, 392 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.|Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, intensity of statin treatment and geographical region. Assignment to arms was done centrally using Interactive Voice/Web Response System in 2:1 ratio (alirocumab: ezetimibe) after confirmation of selection criteria. 720 participants were randomized.
732304|NCT01644175|The study was conducted at 76 centers in the United States of America. Overall, 640 participants were screened between July 2012 and February 2013, 324 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.|Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke, and intensity of statin treatment. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:2 ratio (placebo: alirocumab) after confirmation of selection criteria. 316 participants were randomized.
732305|NCT01644149|Up to 100 subjects between the ages of 18 and 59 were planned with 83 subjects enrolled and 82 subjects vaccinated. Pre- and post-vaccination serum samples were collected from 78 subjects and were analyzed in the Efficacy population.|A total of 83 subjects were recruited and 78 (39 Stratis® and 39 NS) completed the study. One Stratis® group subject (subject # 23) discontinued from the study prior to vaccination.
732306|NCT01644058|Calling patients on the waiting list of the undergraduate implant clinic of the Université de Montréal and referrals from active study subjects.|
732307|NCT01643928|This was an extension study for participants with active rheumatoid arthritis who had participated for at least 16 weeks in a prior rituximab-Pfizer protocol (B3281001) and had not received intervening treatment with investigational agents or other biologics (including Rituxan and MabThera).|Participants given PF-05280586 in Study B3281001 received PF-05280586. Participants given licensed product in Study B3281001 received the same licensed product or PF-05280586 in Course 1. All participants received PF-05280586 in later courses. 185 participants were randomized to Study B3281004, 183 participants received study treatment.
732308|NCT01643902||
732309|NCT01643876|Recruitment from the prosthodontic clinics of the Université de Montréal and of Ribeirão Preto Dental School. Recruitment period dates: May 2012-February 2013.|
732310|NCT01643850|Thirty-seven subjects diagnosed with PVNS or GCTTS were evaluated as part of this study. In all, 36 subjects were treated in three parts (Parts A, B and C) of the study, 30 of whom completed the study. At this final analysis, 6 treated subjects had discontinued from the study.|
732311|NCT01643798|Prospective participants were interviewed over the phone prior to being invited to a screening visit in the Brain Stimulation Laboratory at MUSC. Risks and benefits were explained and consent was obtained. All participants were tested for opiate use and females were tested for pregnancy. Recruitment began in 2011 and ended in early 2012.|Healthy volunteers were randomized to receive I.V. saline or naloxone immediately prior to sham and real rTMS on the same experimental visit. One week later, each participant received the novel pretreatment but the same stimulation paradigm. One participant dropped out after her first experimental visit. These data were not included.
732312|NCT01643772|The study was conducted in phase I unit in two public hospitals, the first subject took the first dose study medication on 13May2011, the last subject took the last dose on 6Jul2012.|The study has a 7-days screening phase, for the subject who meet all the inclusion and exclusion criteria was dosed without run-in or wash out period.
732313|NCT01643668||
732314|NCT01643616|Adult patients were informed and included in the study in the anesthesiology outpatient clinic as part of normal pre-operative preparation. Using a computer-generated list of random numbers, patients were randomly allocated to either the nerve stimulation group (NS group, n=125) or the ultrasound group (US group, n=125).|
732315|NCT01643525||
732316|NCT01643473||
732317|NCT01643382||
732318|NCT01643213||
732319|NCT01643044||
732320|NCT01642914|Patient recruitment occurred at 136 study sites in the US and 5 study sites in Canada over a 6 month period from August of 2012 to February of 2013.|Enrolled participants had up to 21 days of screening (screening period) to determine eligibility for entry into the study's pretreatment period. After an additional 14 to 21 days of pretreatment, those patients meeting entry criteria were randomized for 12 weeks of double-blind treatment.
732321|NCT01642732||
732322|NCT01642615|Participants took part in the study at 18 investigative sites in Mexico, Poland, Portugal and the United States from 22 June 2012 (first participant to sign the informed consent) to 10 November 2014.|Sixty three adolescents with a diagnosis of erosive esophagitis (EE) were enrolled in the dexlansoprazole delayed release 60 mg capsules open label phase. One participant was not treated. Participants with healed EE were randomized into one of 2 treatment groups: dexlansoprazole delayed release 30 mg capsules or placebo in the maintenance phase.
732323|NCT01642602|Participants took part in the study at 36 sites in the United States, Belgium, Hungary, Italy, Poland, Portugal, Brazil, and Mexico from 22 June 2012 to 21 January 2014.|Adolescent participants (male or female), aged 12 to 17 years (inclusive) with symptomatic non-erosive gastrointestinal reflux disease were enrolled in 1 group and received dexlansoprazole 30 mg orally once daily for up to 4 weeks.
732439|NCT01635998||
732324|NCT01642589|The study participants were enrolled from 13 July 2012 to 17 December 2012 in 8 clinic centers in South Korea.|A total of 300 participants that met all inclusion but none of the exclusion criteria were randomized and vaccinated in this study
732325|NCT01642485||
732326|NCT01642407||The study was conducted at 3 sites in Japan. Data reported is based on data cut-off date of 26 December 2016.
732327|NCT01642277|Recruitment began on July 16th, 2012 and ended on May 22nd, 2014 (i.e., 22.2 months). Participants were recruited during their outpatient appointments to the Urogynecology Clinic at Loyola University Medical Center (Maywood, IL) by a member of the research team.|This was a 12-week open label study with no randomization scheme. Following diagnosis, patients were administered 5 mg daily solifenacin. At the 4-week visit, if a participant's symptoms were adequately controlled (response), she continued at dose for the study duration. If a participant reported no improvement, the dose was increased to 10 mg.
732328|NCT01642251|This study opened to accrual on 9/28/2012, was suspended to accrual on 7/23/2013 after nine patients had been enrolled to phase I portion of the trial (3 patients at dose level 1; 6 patients at dose level 2). Phase II portion of the trial was activated on 10/24/2013 and enrolled 147 patients prior to study accrual completion on 7/2/2015.|
732329|NCT01642238|15 healthy volunteers recruited between July 2012 and March 2013|
732330|NCT01642212||
732331|NCT01642147|Recruitment period: 11.01.2012-01.31.2013 Study location: Huashan Hospital Fudan University Location Type: Medical centre affiliated to medical university|Transcranial doppler (TCD) and head CT-scan was used to exclude patients with intracranial hypertension,cerebrovascular diseases, or metastatic brain tumor.
732332|NCT01642082|All patients underwent disease evaluation with baseline CT of the chest, abdomen and pelvis. After obtaining informed consent and verification of eligibility, patients were enrolled and treatment initiated.|
732333|NCT01642004||A total of 352 participants enrolled in the study; 272 were randomized to a treatment group. Of the 80 participants not randomized, 67 no longer met study criteria, 6 experienced an Adverse Event (AE), 3 withdrew consent, 3 died, and 1 failed screening. Study is ongoing.
732334|NCT01641991|Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled and vaccinated between 05JUL2012 and 30NOV2012.|
732335|NCT01641978|neurological and neurosurgical patients|
732336|NCT01641952|A total of 505 participants were recruited in 58 centers.|
732337|NCT01641939||A total of 415 participants were randomized, of these 117 participants in taxane arm, 228 participants in 2.4 milligram per kilogram (mg/kg) trastuzumab emtansine arm, and 70 participants in 3.6 mg/kg trastuzumab emtansine arm received at least one dose of the treatment.
732338|NCT01641926|Hepatitis B envelope antigen (HBeAg)-positive or -negative participants who were interferon treatment-naïve were recruited from 81 sites to be randomly assigned to receive pegylated inferferon alfa-2b (PEG-Intron™) or pegylated interferon alfa-2a (PEGASYS™).|402 participants were enrolled and 399 participants were treated on study.
732339|NCT01641900||
732340|NCT01641861|The study population consists of students attending primary schools in Khon Kaen province, Thailand. Consented children were obtain clinical and radiographic examination at the Pediatric Department, Faculty of Dentistry, Khon Kaen University (KKU) in order to evaluate for their eligibility. The recruitment period were November 2012 to August 2013.|Among of 1299 children provided the consent and received an oral examination, 518 children received a radiographic examination for definite diagnosis. From 494 eligible children, 488 have been enrolled. The rest were not enrolled either because of parental refusal (n=2), child refusal (n=3), or the child moved to another province (n=1).
732341|NCT01641835||
732342|NCT01641822|Participants were enrolled at study sites in the United States. The first participant was screened on 13 December 2012. The last study visit occurred on 15 January 2015.|Following enrollment, participants received tobramycin inhalation solution (TIS) in the TIS Run-In Phase, and if still eligible were randomized 1 to 1 to receive aztreonam for inhalation solution (AZLI) or placebo to match AZLI alternating with TIS in the Comparative Phase.
732343|NCT01641809|This was a multicenter, two part study in human immunodeficiency virus-1 (HIV-1) infected antiretroviral therapy (ART) naïve adult participants conducted across 48 sites in the United States (US) and Canada.|A total of 324 participants were screened, of which 80 failed screening and 244 participants were randomized to one of the four treatment arms in a ratio of 1:1:1:1. Of the 244 randomized participants, only 243 received atleast one dose of study treatment and comprised the Intent-to-Treat-Exposed (ITT-E) Population.
732344|NCT01641692||Participants were randomized to receive a sequence of 3 of 8 possible treatments over 3 treatment periods. There are 56 combinations of 3 treatments from the 8 study treatments, each of which can be ordered in 6 ways (totaling 336 possible sequences; 246 were randomly assigned). Participant Flow data are presented by treatment rather than sequence.
732345|NCT01641653|6/21/11-8/9/12 preoperative holding area|Non diabetics with fasting blood sugar < = to 110mg/dL scheduled for an elective hernia repair
732346|NCT01641640|Subjects were enrolled in a total of 55 study sites in the United States. The first participant was screened on 18 June 2012. The last participant observation was on 16 April 2013.|456 participants were screened and 328 were enrolled; 327 participants were treated, and comprise the Safety Analysis Set and the Full Analysis Set.
732347|NCT01641601||
732348|NCT01641471||
732349|NCT01641445||
732350|NCT01641380|This research study was conducted in a large urban academic General Pediatric and Adolescent Medicine Practice in Baltimore, Maryland between October 2011 and February 2012.|
732351|NCT01641367|Participants were enrolled between 22FEB2013 and 21DEC2015 at non-US based clinical research sites.|
732352|NCT01641237|Participants were recruited at the clinical site.|A total of 72 participants were screened, and 62 were randomized into the study. 9 participants did not meet the study criteria and 1 withdrew consent. A washout non-fluoridated toothpaste was used for 2 days prior treatment. In-situ appliances were prepared for participants to fit enamel specimens.
732353|NCT01641198|Recruitment period: 1990 - 1992|Sixty participants were recruited; however, two participants opted out prior to informed consent and random assignment to an arm.
732354|NCT01641159||
734624|NCT01491672|This was an open-label study where all eligible participants were enrolled into one of 3 cohorts based upon prior first-line therapy.|
732355|NCT01641133||457 subjects were enrolled in the study. Of these, 5 subjects were not included in the Total Vaccinated Cohort, as the study vaccine was not administered. In addition, 157 subjects enrolled at one center were excluded from analysis because of GCP deficiencies, and 1 subject from another center because of invalid Informed Consent form.
732356|NCT01641120||
732357|NCT01641081|"The study was conducted in 29 study centers in the United States
~First patient visit was in June 2012 and last patient visit was in February 2013"|A total of 408 patients were screened; there were 234 screen failures, primarily (225/234) because inclusion/exclusion criteria were not met
732358|NCT01641042||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
732359|NCT01640964|Out of 47 enrolled patients, 1 patient did not get randomized to Part A serelaxin arm ; patient withdrew consent due to failure of meeting an exclusion criterion for Part A prior to receiving the dose of study medication.|
732360|NCT01640951|675 subjects from the core studies (CAIN457A2304 and CAIN457A2307) were enrolled at 112 sites. Subjects enrolled in the secukinumab 300 mg Open-Label (OL) arm came only from the CAIN457A2307 study, as such they were partial responders at Week 12, while all other subjects in the extension were PASI 75 responders at Week 12 in the core study.|At Week 156, subjects who rolled over from the CAIN457A2304 study were unblinded and provided an option to switch to one of the treatment options described below upon investigator judgment; subjects from the CAIN457A2307 study could administer study drug at home every 4 weeks, but were required to come for office visits every 12-16 weeks.
732361|NCT01640925||
732362|NCT01640873|Participant was a male or female (of non-child bearing potential) between 18 to 65 years of age with a diagnosis of Type 2 diabetes mellitus (T2DM) and was either drug naïve or was being treated with metformin only.|
732363|NCT01640834||
732364|NCT01640808||Screened:778 Enrolled:616 Received treatment:610
732365|NCT01640548||
732366|NCT01640379||
732367|NCT01640366|There were 200 participants enrolled in this study.|
732368|NCT01640353||
732369|NCT01640340|Patients were screened for eligibility during routine clinic visits by a physician, nurse practitioner or pharmacist involved in their care.|Patients were stratified based upon their chemotherapy regimen (cisplatin versus noncisplatin containing) and then randomized to the ondansetron or palonosetron group.
732370|NCT01640327|Subjects were enrolled at one study centre in Germany.|All enrolled subjects were included in the trial.
732371|NCT01640314|Subjects were enrolled at one study centre in Germany.|All enrolled subjects were included in the trial.
732372|NCT01640288|An open label study in subjects with normal lung function and subjects diagnosed with chronic obstructive pulmonary disease (COPD) over five years. We recruited 100 normal subjects (non-, ex- and current smokers with normal PFT's) and 71 subjects with COPD (varies stages of GOLD I-IV (Global Initiative for Obstructive Lung Disease).|
732373|NCT01640249||This was a 2-part (Part A and Part B) crossover study. Part A was a dose-escalation with up to 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was not initiated as study was terminated early due to technical factors.
732374|NCT01640197|All participants were recruited opportunistically from Northumbria University via spam email and posters around campus.|Before participants were enrolled they were required to complete a training/screening session. If they met the study exclusion criteria or did not perform within the cognitive task norms (compiled from previous studies) then they were not eligible to take part in the study.
732375|NCT01640184||
732376|NCT01640171||
732377|NCT01640054|A total of 115 patients were enrolled; all received at least 1 dose of investigational product. This was an open-label study.|No patients failed screening.
732378|NCT01639872||During the course of the study a pharmacy issue precipitated the need to conduct the study as open label for a period of time. 7 participants (5 CLOZ and 2 RISP) were randomized under open label. Once a replacement pharmacy was in place the study returned to double blind status.
732379|NCT01639833||
732380|NCT01639755||
732381|NCT01639742||
732382|NCT01639729||
732383|NCT01639703|A total of 96 patients were enrolled in 4 countries: Austria, Germany, South Korea and Switzerland.|
732384|NCT01639599||
732385|NCT01639560||
732386|NCT01639495|This study enrolled 148 subjects at 15 clinical sites in the U.S. over the course of approximately 8 months. The first subject was enrolled on July 26, 2012, and the last subject was enrolled on March 18, 2013. The study's last index ablation procedure was on April 24, 2013.|
732387|NCT01639469||
732388|NCT01639443||
732389|NCT01639352||
732390|NCT01639339|This was a Phase 3, multi-center, multi-national, randomized, double-blind, placebo-controlled study that evaluated safety and efficacy of intravenous (IV) belimumab 10 milligrams per kilogram (mg/kg) plus standard of care (SoC) compared to placebo plus SoC in adult participants with active lupus nephritis. The study was conducted in 21 countries.|A total of 797 participants were screened for the study of which 448 participants were enrolled. The results presented are for the primary analysis (double blind treatment period).
732391|NCT01639222||
732392|NCT01639157||
732393|NCT01639144||
732394|NCT01639040|A total of 38 participants were screened in the study between 30 July 2012 and 20 December 2012.|Out of 38 participants, 31 were randomized and treated in the study. Participants were randomized in 2:1 ratio to receive Dupilumab 300 mg or Placebo.
732395|NCT01639001|This phase 3, randomized, open label, multicenter study conducted in 35 centers in 5 countries. A total of 207 actual participants were randomized, 104 in the crizotinib arm and 103 in the chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) arm.|Participants with histologically or cytologically proven diagnosis of locally advanced, recurrent, or metastatic non squamous non small cell lung cancer and tumors with measurable disease were enrolled. Participants were to be positive for translocation or inversion events involving the ALK gene locus as determined by an ALK break-apart FISH test.
732396|NCT01638819||
734625|NCT01491633||
739047|NCT01227434||Of 23 participants consented, 1 was found ineligible prior to randomization
732397|NCT01638559|161 participants were enrolled (11 sites in the US,1 site in Canada) between August 2012 and April 2014. N=88 of the enrolled participants were eligible to initiate immunosuppression withdrawal (ISW) and the remaining N=73 participants were terminated (e.g., ineligible to proceed with ISW) based on biopsy findings or other pre-specified criteria.|Informed consent was obtained from eligible individuals who then underwent a study-mandated biopsy to determine if they were eligible to initiate immunosuppression withdrawal, based on pre-specified histologic and other criteria.
732398|NCT01638546||
732399|NCT01638507|230 PEG subjects were enrolled from 29 study sites in the United States. The first subject was enrolled on July 23, 2012 and the last subject was enrolled on May 31, 2013.|
732400|NCT01638468||
732401|NCT01638429|Study was open for recruitment from April 12, 2012 - Dec 31, 2013 Setting: Tertiary care center|A total of 12 subjects were consented to participate. 1 subject withdrew prior to completing the study.
732402|NCT01638416||
732403|NCT01638390||
732404|NCT01638312||
732405|NCT01638013|Participants who completed 015K-CL-RAJ1 (NCT01649999), 015K-CL-RAJ3 (NCT02308163), 015K-CL-RAJ4 (NCT02305849) and met eligible criteria were enrolled in this study. Participants in the etanercept group in study 015K-CL-RAJ3 (NCT01649999) were not included in this study.|For participants who were on 50mg at the time of peficitinib approval, dose was increased to 100mg. Participants whose dose increment was not possible were discontinued.
732406|NCT01638000|Participants recruited for this study were men and women with overactive bladder (OAB) who had received 1 or more antimuscarinics in the past and who were dissatisfied with their last antimuscarinic treatment due to lack of efficacy (provided that their previous antimuscarinic was not solifenacin).|Participants entered a 2-week, single-blind, placebo run-in period and completed a daily diary (including 3 consecutive days prior to the randomization visit for micturition and incontinence). After this, participants' eligibility criteria were re-confirmed and they were then randomized into the double-blind treatment period of the study.
732407|NCT01637961|The study was activated on 8/6/2012 and closed to accrual on 6/3/2013.|
732408|NCT01637935|Not applicable (database study)|Not applicable (database study)
732409|NCT01637922||
732410|NCT01637870||
732411|NCT01637623||
732412|NCT01637584||
732413|NCT01637402|Participants were recruited through the Urologic Oncology Program at University of California, San Francisco|All participants were prescribed the standard dose(STD). Participants who did not exhibit prostate-specific antigen (PSA) decline at 12 weeks were deemed 'primary-resistant' and taken off study. Participants continued STD until progression, at which time, they were assigned to the escalated dose was for a minimum of 12 weeks.
732414|NCT01637272|43 patients were enrolled as planned; 33 patients completed the core sc phase, 31 patients completed the core LAR phase. Of the 31 patients who completed core LAR phase, 27 patients entered the extension phase. Of the 27 patients who entered the extension phase, 23 patients completed the study.|All patients underwent an OGTT (75g of glucose) and were evaluated at different time points. If the glucose level was <60 mg/dL at 90, 120, 150 or 180 min during the OGTT and all the other eligibility criteria were met, patients were allowed to start study medication. The study was divided in 2 phases, core phase and extension phase.
732415|NCT01637246||
732416|NCT01637090|This study was actively recruiting from within the investigator's own praceice from June 2012 through May 2015 in the hematology/oncology multidisciplinary clinic.|
732417|NCT01637077||
732418|NCT01636986|Participants were recruited from 1 US study center.|This reporting group includes all enrolled and randomized participants.
732419|NCT01636960|This study enrolled Japanese participants with Stage II or III malignant melanoma who had undergone surgical resection and lymphadenectomy.|
732420|NCT01636947||
732421|NCT01636934|Recruitment period: January 22, 2013 to August, 19 2015. All recruitment done at the University of Texas MD Anderson Cancer|Of the 51 participants enrolled 2 participant were excluded from the study before assignment to groups.
732422|NCT01636882|Subjects were recruited from medical clinics from 03 July 2012 to 29 July 2015 (last subject enrolled in VLA-008).|Subjects were screened for and excluded from the study if they had pre-existing antibodies to CVA21.
732423|NCT01636778|Participants with chronic hepatitis C (CHC) or compensated liver cirrhosis, who cannot start polyethylene glycol (Peg)-interferon (IFN)/ribavirin (RBV) therapy due to thrombocytopenia (platelet count <80 giga (10^9) cells per liter (Gi/L).|The total study duration was a maximum of 88 weeks, which consisted of a Screening Period of less than or equal to 45 days, the Pre-Antiviral Treatment Period (Part 1) from 1 up to 9 weeks and the Antiviral Treatment Period (Part 2) of 48 weeks and Follow-up Period of 24 weeks.
732424|NCT01636765||
732425|NCT01636713|Participants who met eligibility criteria at Screening (Visit 1) completed a 7 to 14-day run-in period and were then randomized to a 24-week treatment period.|A total of 739 participants were screened; 580 participants were randomized in a 1:1:1 ratio to receive either one of the active treatments or placebo. One participant was randomized but data was excluded from analysis as requested by the local Ethic Committee because the participant was not consented according to the GCP standards.
732426|NCT01636687|59 placebo subjects completed induction phase. These 59 entered maintenance phase. Of those, 28 were assigned to 150mg AIN457 and 28 were assigned to 300 mg AIN457, while 3 remained with PLC treatment.|A total of 220 patients were screened at 39 study centers, and 182 patients were randomized at 38 study centers to 3 balanced groups.
732427|NCT01636661||If a child did not exhibit a motor evoked potential from the ipsilesional cortex, they were excluded from the trial after enrollment but before assignment to a group.
732428|NCT01636466||
732429|NCT01636453||
732430|NCT01636414||
732431|NCT01636362||
732432|NCT01636297||
732433|NCT01636284||
732434|NCT01636258|Participants were recruited between May and August, 2012. Recruitment methods included flyers distributed to health centers, libraries, and community health outreach events; advertisements in Cleveland Clinic and Community newsletters; and a television appearance on popular Sunday morning news program by one of the research team members.|Two participants who were enrolled in study were excluded at baseline laboratory check due to glycated hemoglobin (HgbA1c) value below 5.7%.
732435|NCT01636206||
732440|NCT01635933|Participants were recruited from 24 study centers located in the United States.|Of the 370 participants enrolled and randomized, 4 did not meet inclusion/exclusion criteria, 2 were lost to follow-up, and 1 declined participation. This reporting group includes all participants exposed to the study product (363).
732441|NCT01635920|Participants were recruited from 15 study centers located in the United States.|Of the 258 participants enrolled, 7 participants did not receive study lenses. This reporting group includes all enrolled and randomized participants who received study lenses (251).
732442|NCT01635881|Recruitment of subjects for EMERGE study started on July 09, 2012 and completed on December 14, 2012. Subjects were recruited at 3 investigational centers.|
732443|NCT01635855||
732444|NCT01635764||Subjects were evaluated for entry into Study M12-555 at the final study visit of the prior phase 3 study in which they participated. Therefore, the Study M12-555 Week 0 visit and administration of the first dose of study drug in Study M12-555 was performed on the same day as the final or last visit of the prior Phase 3 study.
732445|NCT01635504||
732446|NCT01635439|290 women were assessed for eligibility, 62 women were excluded (35 did not meet the inclusion criteria, 21 declined to participate and 6 refused induction of labor as a method of delivery)|Among the 228 women who met the eligibility criteria, 7 went into spontaneous labor and 4 had pathological Cardiotocography (CTG), so were excluded from being assigned to one of the treatment groups. After allocation 17 women were excluded from the analysis (15 refused to continue the induction of labor and had 5 incomplete records).
732447|NCT01635283|Dates of recruitment period: 1/2012 - 8/2015 Types of location: Medical clinic|Study enrollment patients must satisfy inclusion criteria, screening evaluations (vital signs, history, physical, neurological exams, Karnofsky Performance Scale, brain MRI , urinalysis, complete blood count, differential, platelets, coagulation tests), underwent leukapheresis, and had suitable Dendritic Cell (DC) Vaccine manufactured for them.
732448|NCT01635244||
732449|NCT01635218|The study was conducted in a public, academic and research hospital in Mexico City. Participants were recruited since March 2012 until December 2013. The recruitment methods included advertisements through internet, community groups,liaisons with health professionals, posters and brochures distributed among hospital population.|Five hundred thirty-four women seeking medical care for menopausal complaints were interviewed and screened. Four hundred and one women did not meet inclusion criteria and were excluded: no depression (44), mild depression (150), severe depression and/or attempt of suicide (43), did not meet other inclusion criteria (164).
732450|NCT01635153||
732451|NCT01635101||Of 215 participants screened, 197 were actually enrolled and received study drug
732452|NCT01635062|"Subjects were recruited from the local Boston community
~A total of 41 participants were consented to participate. Subsequently, 13 were found ineligible, 5 withdrew participation, 3 were lost-to follow-up, and 2 were withdrawn for non-compliance with the washout. Therefore, 18 were randomized."|"An anti-hypertensive medication washout was conducted to minimize confounding of the renin-angiotensin system.
~ACE inhibitors, angiotensin-receptor blockers, and mineralocorticoid receptor antagonists, beta blockers, diuretics, and calcium-channel blockers were withdrawn for 2 weeks to 2 months prior to randomization."
732453|NCT01634854||
732454|NCT01634659|Participants were recruited from 18 study centers located in the US.|Of the 330 participants enrolled, 17 were exited from the study prior to randomization and dispense of product.This reporting group includes all randomized and dispensed participants (313).
732455|NCT01634620|Participants expressing interest who met inclusion and exclusion criteria were asked to sign written informed consent prior to participation.|
732456|NCT01634555||
732457|NCT01634360||
732458|NCT01634269||
732459|NCT01634256|Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.|The criteria were an age from 19 to 70 years, ALT levels ≥ 40IU/L subjects.
732460|NCT01634243||
732461|NCT01634165||This was a 4-treatment, 4-period, crossover, euglycemic clamp study. Participants were randomly assigned to 1 of 4 dosing sequences.
732462|NCT01634152||
732463|NCT01634139||
732464|NCT01634113||
732465|NCT01634100||This was a randomised, 3-way crossover trial. 18 patients were randomised to one of six treatment sequences and treated. It was an open label trial in which each treatment period lasted 4 days with a washout period of at least 7 days between each.
732466|NCT01633944||Of 1633 subjects screened, a total of 752 subjects were enrolled into the open-label (OL) titration phase. Subjects who completed the OL titration phase (462) were eligible for randomization in the double-blind (DB) treatment phase.
732467|NCT01633892||
732468|NCT01633853||
732469|NCT01633827|Patients with a previous diagnosis of OSA (defined as an apnoea/hypopnoea index [AHI] >10/hr) were recruited from the sleep clinic and Brigham and Women's Hospital and the general community (Boston, MA). The first patient was recruited in September 2012 and the last patient enrolled in May 2014.|
732470|NCT01633814|Total enrollment was 4 women. Study was terminated prematurely early due to poor enrollment and the fact that the PI was moving to another institution. No data was analyzed.|
732471|NCT01633788||Patients from one site were excluded from the modified intent-to-treat analysis population due to compliance issues. Patients from this site who received study treatment were included in the safety population and are reflected in the participant flow.
732472|NCT01633320|"Study performed between June and July 2012 at Édouard Herriot university hospital,Lyon, France.
~200 American Society of Anesthesiologists physical status I-II patients undergoing general anesthesia were included. The procedures performed were ear, nose and throat surgery or endoscopy and plastic surgery."|No patient were excluded from the trial before assignment to groups
732473|NCT01633112||A total of 1461 subjects were screened for participation in this study; of those, 1064 subjects were randomly assigned to study treatment
732514|NCT01630200|Patients were recruited from the Department of Respiratory and Critical Care Medicine in the Otto Wagner Hospital in Vienna and supporting centres (hospitals, outpatient clinics, respiratory specialists).|After inclusion, patients entered a 4 week, single-masked run-in period with placebo application. Given sufficient compliance to medication (≥70% of tablets) patients were randomized to receive either the study drug (Roflumilast 500 μg) or placebo in a double-masked manner.
732474|NCT01633060|This study was conducted at 201 centers in 22 countries worldwide (Argentina, Austria, Belgium, Bulgaria, Canada, Colombia, Finland, France, Germany, Greece, Hungary, Italy, Republic of Korea, Lebanon, The Netherlands, Norway, Poland, Spain, Sweden, Thailand, UK and USA).|At least 420 patients were planned to be enrolled, randomized in a 2:1 ratio (two buparlisib, one placebo). A total of 432 patients were actually enrolled and analyzed (buparlisib arm: N=289; placebo arm: N=143). Not completed: in Randomization Phase=Randomized and not Treated; in Treatment Phase=Discontinued study treatment per Protocol.
732475|NCT01632995|Participants were screened and enrolled at 3 sites in the US (San Francisco, Miami, Washington DC). Enrollment began on October 1, 2012 and ended February 10, 2015.|"As this PrEP Demonstration project assessed acceptance of PrEP, all participants assessed for participation are included in the start category, and those who enrolled and initiated PrEP are indicated as a separate milestone."
732476|NCT01632904||
732477|NCT01632891|Participants were recruited from 5 clinics in Africa. The first participant enrolled on January 10, 2014. The last participant enrolled on May 20, 2016.|
732478|NCT01632878|1531 patients were screened and the decision to treat patients with Omacor was made by the treating physician. 268 patients were not treated with Omacor according to the protocol. Only baseline characteristics were reported without any further follow-up for these patients.|268 patients screened but not treated with Omacor on physician decision as per the protocol. Consequently 1263 entered in Omacor 1 year treatment assessment
732479|NCT01632800||
732480|NCT01632735||
732481|NCT01632709||Subjects were not assigned to an arm until Visit 2 (randomization).
732482|NCT01632683||
732483|NCT01632579||The study had 3 periods. Period 1: 0.1 milligram (mg), 0.5 mg, 2.5 mg LY3023703 or placebo. Period 2: 10 mg, 30 mg, 60 mg LY3023703 or placebo. Period 3: 400 mg celecoxib. There was at least a 3-week washout between periods and at least 7 days between dosing of each cohort in Periods 1 and 2.
732484|NCT01632566||Study enrolled participants of both Japanese and non-Japanese decent. Participants were pooled regardless of ethnicity. Participants assigned to 75 milligrams (mg) LY3031207 and 225 mg LY3031207 underwent identical procedures as those assigned to 25 mg LY3031207 with the addition of 10 mg open-label simvastatin administration on Days -3 and 28.
732485|NCT01632423||
732486|NCT01632345||210 participants were randomized to Part I and 132 participants were randomized to Part II.
732487|NCT01632306||
732488|NCT01632280|Participants were recruited between June 2012 and July 2014 from the Weight Loss Surgery Center at Beth Israel Deaconess Medical Center.|2 participants withdrew from the study after enrollment but prior to assignment to a treatment arm.
732489|NCT01632267||
732490|NCT01632241|This study evaluated the efficacy and safety of belimumab compared with placebo in adult participants with Systemic Lupus Erythematosus (SLE). This was a multicenter study conducted at United States (88 centers), United Kingdom (6), South Africa (5), France (4), Columbia (6) and Brazil (18).|A total of 503 participants were randomized of which 496 received at-least one dose of study medication during double-blinded phase (7 participants were randomized but not treated as they were randomized in error). A total of 359 out of 373 participants who completed double-blinded phase opted to continue optional open-label (OL) extension phase.
732491|NCT01632215||
732492|NCT01632202||11 signed a consent form, but only 8 were randomized.
732493|NCT01632150||Of 51 participants enrolled, 40 received treatment. Of those 40, 11 had cyclophosphamide added to their regimens.
732494|NCT01632020|Study was open for enrollment between 7/13/2012 and 3/5/2014. Subjects were recruited from medical clinics at the University of Arkansas for Medical Sciences (UAMS) and the Central Arkansas Veterans Healthcare System (CAVHS).|There were no significant events following participant enrollment, prior to group assignment.
732495|NCT01631929||
732496|NCT01631864||
732497|NCT01631825||
732498|NCT01631812||
732499|NCT01631747|Women were screened from multiple practices at the Prentice Women's Hospital of Northwestern Memorial Hospital. Screening took place between Feb 2013-Dec 2015.|Women completed baseline clinic visit and two 24 hour recalls prior to randomization.
732500|NCT01631682||186 individuals initially signed a consent form. Of these 186 individuals who gave signed consent, 14 had unmeasureable skin conductance levels and were not able to participate in the study, leaving 172 individuals who participated.
732501|NCT01631656||
732502|NCT01631630||
732503|NCT01631474||
732504|NCT01631435||"total of 39 cases have been excluded and were not enrolled to the study due to the follwoings: 38 cases are screen faliure
~1 case due to physican decision - the patient not eligible for the study"
732505|NCT01631331||Patients had 1 to 2 target BCCs identified at baseline for surgical excision. n = 13 target lesions n = 30 non-target lesions
732506|NCT01631227||
732507|NCT01631214|The study was conducted at 270 centers in 41 countries globally from 04 May 2012 to 29 June 2017.|Participants were randomized in a 1:1 ratio to receive romosozumab or alendronate for 12 months. Randomization was stratified by age (< 75 vs. ≥ 75 years). After completion of the double-blind trial period, all participants received open-label alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.
732508|NCT01631149|A total of 30 patients were recruited. In 4 one or more exclusion criteria were met, the others were randomized; 2 patients withdrew consent; two others replaced them.|No significant events occurred that delayed or interfered with the enrollment
732509|NCT01631110|Recruitment period: 23 July 2012 to 14 August 2012; outpatient study|
732510|NCT01631071|Recruitment period: 03 August 2012 to 27 August 2012; outpatient study|
732511|NCT01630811||
732512|NCT01630694|Recruitment period for this study is from 11-3-2010 to 10-1-2012 done in a medical clinic setting.|Enrollment goal for this study was met so the study was closed.
732513|NCT01630616|Recruitment continued until the Odanacatib Development Program was discontinued on 02-Sep-2016. No participants were actively receiving treatment at the time of study discontinuation.|The Young Adults Odanacatib 10 mg arm represents historical data from a separate study (MK-0822-007). As such, these participants were not enrolled in any part of the current MK-0822-066 study.
732515|NCT01630135||
739048|NCT01227421||
757938|NCT00185731||
732524|NCT01629706|Participants were recruited from 1 study center located in Canada.|A total of 92 unique participants were enrolled in the study, 44 in Phase 1 and 48 in Phase 2. Additionally, Phase 2 enrolled 10 participants from Phase 1, for a total of 58 participants in this Phase.
732525|NCT01629693|Participants were recruited from 22 sites located in the United States.|Of the 398 enrolled, 17 participants were exited as screen failures. This reporting group includes all participants who provided informed consent, were randomized, and utilized the study lenses (381).
732526|NCT01629667|A total of 409 participants participated in the study. Of which, 176 participants were randomized into the study at 48 sites including 17 sites in the USA, 9 sites in Australia, 7 sites in Peru, 6 sites in Israel, 5 sites in Canada, and 4 sites in South Korea.|A total of 176 participants were randomized into the study. Three participants who were randomized did not receive treatment; therefore, 173 participants were randomized and treated.
732527|NCT01629615||
732528|NCT01629589|The study participants were enrolled from 20 June 2012 to 10 September 2012 at 8 centers in the United States.|A total of 423 participants that met all of the inclusion and none of the exclusion criteria were randomized, 422 were vaccinated in this study.
732529|NCT01629563||
732530|NCT01629511|Participants enrolled at MD Anderson clinic starting on November 21, 2012 on Phase I of the study. No participants were enrolled on Phase II.|
732531|NCT01629329|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
732532|NCT01629290|15 subjects were enrolled. All 15 subjects participated in the four arms/groups and received all four interventions for a total of 60 treatments.|Treatment consisted of the application of 0.4 ml of either a 5% NaF varnish, or a placebo (no fluoride) varnish applied to the buccal surfaces of all the teeth. After a minimum of 2 weeks washout period, the next randomly assigned treatment was given. All subjects received the 4 different treatments.
732533|NCT01629134||
732534|NCT01628965||
732535|NCT01628926||
732536|NCT01628913||Patients were assigned to one of the following 2 treatment arms in a ratio of 1:1: BEZ235 (investigational arm) or everolimus (control arm)
732537|NCT01628874||Due to low enrollment, the study was halted prior to getting to the planned protocol enrollment. The patients who were enrolled were used in the analysis per the participant flow module.
732538|NCT01628848||
732539|NCT01628718||
732540|NCT01628692|The study was conducted at 25 centers in 6 countries.|Of the 230 participants enrolled, 168 received treatment.
732541|NCT01628614||
732542|NCT01628601||
732543|NCT01628588||
732544|NCT01628549||
732545|NCT01628523||
732546|NCT01628510|One hundred infants were enrolled from January 2011 through November 2011. Four infants withdrew, and four infants died. Ninety two participants were discharged from the NICU.|All eligible infants were recruited. Those whose parents signed informed consent were randomized to either traditional positioning or Dandle Roo positioning.
732547|NCT01628367|Double-group, parallel, single-blinded, randomize clinical trial|Forty-eight patients were consented and screened; 35 initially included then 3 excluded based on socket morphology after extraction. Final enrollment = 32
732548|NCT01628250||
732549|NCT01628198||
732550|NCT01628159||
732551|NCT01628120|Participants with chronic renal failure were receiving Epoetin maintenance therapy in study EPOE-10-13 (NCT01473420) prior to enrollment and treatment in the current study.|
732552|NCT01628107|Participants with chronic renal failure were receiving Epoetin maintenance therapy in study EPOE-10-01 (NCT01473407) prior to enrollment and treatment in the current study.|
732553|NCT01628042||
732554|NCT01628016|The training sessions were held in Hunan Normal University from September 14 - October 1, 2011.|Participants were randomly assigned to one of the three conditions by a computer-generated random assignment. Randomization was stratified by depression severity and gender.
732555|NCT01627899|At medical clinic.|
732556|NCT01627860|55 participants were randomly assigned to receive either topiramate monotherapy or add-on therapy at 6 sites in Taiwan.|
732557|NCT01627782||A total of 165 participants were screened and 68 participants were randomized into the study. Of these 68 participants randomized, 67 participants received at least 1 dose of the study agent (Intent-To-Treat analysis set).
732558|NCT01627691||
732559|NCT01627574|This project enrolled 272 at-risk females aged 14-21. Participants were eligible if they had sexual intercourse with a male partner in the past four months, were not pregnant and intended to have intercourse with a male in the next 6 months. Recruitment began in February of 2013 and the last participant was recruited in August of 2017.|
732560|NCT01627561|This study was conducted by multiple investigators at 7 centers in Colombia, Mexico and Panama.|All 148 subjects enrolled in the study, received the study vaccination and were included in the Total Vaccinated cohort (TVC).
732561|NCT01627340||There was re-allocation of 7 subjects conducted due to certain discrepancies between subjects' attributes identified from two different sources and as a result of which, there was an increase in the number of subjects from the 667 subjects targeted initially.
732562|NCT01627327||Eligible participants (par.) completed a 2-week Run-in Period (RIP) to obtain baseline assessments of rescue use, COPD symptom scores and disease stability. Par. were then randomized to a 12-week Treatment Period. A total of 890 par. were screened, of whom 623 were randomized and received at least one dose of study medication.
732563|NCT01627288||
732564|NCT01627249||
732565|NCT01627067|Patients were recruited from October 2012 to September 2013. The participating subjects must sign the consent document pertaining to the study and meet all the eligibility criteria as mentioned in the protocol, before initiating on the study treatment.|
732566|NCT01627002|The study was conducted from June 2012 (first subject dosed) to April 2013 (last subject visit). The study was conducted in 2 parts; Part A was a single ascending dose study, Part B was a randomised placebo-controlled study to investigate the effect of a single dose of PA401 on sputum neutrophils following inhaled lipopolysaccharide challenge|In Part B, subjects were included at baseline if they had a baseline neutrophil level in induced sputum of ≤70%
732572|NCT01626456|Subjects who successfully completed the Day 85 visit in Study ALK9072-003 and continued to meet eligibility criteria were eligible to enroll in this extension study. In addition, adults with chronic stable schizophrenia on a stable oral antipsychotic medication not previously enrolled in Study ALK9072-003 were also eligible to enroll.|While there were only 2 treatment groups in this extension study (low dose and high dose), data for several outcome measures is presented by lead-in study groups, and separated into 5 categories: PBO-441 mg, 441-441 mg, PBO-882 mg, 882-882 mg, and de novo.
732573|NCT01626391||
732574|NCT01626352|Between October 2012 to July 2014, 22 subjects with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) were screened for enrollment in the study at 12 investigational sites in the U.S.. Of those, 21 were treated.|
732575|NCT01626118||
732576|NCT01626092||
732577|NCT01626079|"In COAPT, 614 subjects were randomized. Enrollment concluded on June 23, 2017.
~Of the 614 randomized subjects, 302 were in Device group and 312 in the Control group. Subject follow-up is on-going."|This section includes the results for the primary safety, primary effectiveness, and the 10 secondary endpoints that are the most essential outcomes of the trial.
732578|NCT01625988||
732579|NCT01625923||
732580|NCT01625910|Study enrollment occurred from Sept 2011 - May 2012. Permission was first obtained from the clinicians and then the parent-child dyads who agreed gave written parental consent and, if the child was at least 8 years of age, child assent. Prior to randomization, a parent answered the intake survey and child ht and wt were re-measured by the RA.|After enrollment, the children were randomly assigned to either the intervention or control group. The intervention and control group protocols began on the day of enrollment, immediately after group assignment
732581|NCT01625845|Recruitment was open from June 28, 2012 to February 28, 2014. Participants were recruited from Eskenazi Health and Indiana University Health primary care clinics in Indianapolis. 1369 patients were screened, of whom 36 (2.6%) were eligible and provided informed consent. 16 patients (44%) attended the pre-treatment visit and were randomized.|
732582|NCT01625689||309 participants were consented and enrolled in the study. 9 participants were ineligible to receive study vaccination. 300 total participants were vaccinated and followed through the study period.
732583|NCT01625507||
732584|NCT01625455||Seven subjects were consented and enrolled. Two did not meet inclusion/exclusion criteria and were not randomized.
732585|NCT01625416||
732586|NCT01625377||Total 188 patients were randomized
732587|NCT01625338|Participants were enrolled at a total of 152 study sites from their prior Gilead study in North America, Europe, Australia, and New Zealand. The first participant was screened on 22 June 2012. The last study visit occurred on 22 December 2014.|585 participants were screened.
732588|NCT01625286||
732589|NCT01625221||
732590|NCT01625182||Participants were assigned randomly to each treatment group in a 1:1 ratio.
732591|NCT01625169||
732592|NCT01625104|6 sites were randomized to the aggressive strategy and 6 sites were randomized to control.|Site were randomized according to baseline Door to Balloon times.
732593|NCT01625091||
732594|NCT01625013||
732595|NCT01624974||Period I (443 participants) was a Pre-study screening period. Period II (186 participants) was a Run-in period in which participants received open-label montelukast (ML) 10 mg and matching single-blind placebo once daily (QD). Whereas 443 participants were screened, 107 eligible participants were enrolled and randomized to treatment in Period III.
732596|NCT01624948||
732597|NCT01624870||
732598|NCT01624740||Although 20 subjects enrolled (11 to receive low rate stimulation first, 9 to receive high rate stimulation first), 2 subjects randomized to first receive low rate stimulation were withdrawn prior to stimulation due to difficulties implanting the device. Thus, 18 out of 20 enrolled subjects (9 from each group) started their first intervention.
732599|NCT01624662||
732600|NCT01624467||Completers are defined as the QTc complete participants who received full doses of necitumumab for ≥1 full 6-week cycle or did not complete the first cycle because of QTc prolongation, and had pretreatment and post-infusion triplicate ECGs at the times specified in all versions of the protocol.
732601|NCT01624363||
732602|NCT01624350||
732603|NCT01624259||
732604|NCT01624233|Period 2-Induction Dosing Period (Weeks 0 up to 12), Period 3-Maintenance Dosing Period (Weeks 12 up to 52), Period 4-Drug Free Period (Weeks 52 up to 100), Period 5-Retreatment Period (up to 192 additional weeks) and Period 6-Post-Treatment Follow-Up Period up to 12 weeks after the last visit.|
732605|NCT01624194|"This study was conducted in the Autism and Developmental Disabilities Clinic in the Division of Child and Adolescent Psychiatry at Stanford University. Recruitment began in June 2012 and ended in April 2016.
~Participants were recruited through the Stanford Autism Research Registry, flyers posted in the community, posted online and special events."|54 subjects were consented and assessed for eligibility. 19 subjects were excluded (13 did not meet inclusion criteria and 6 declined to participate). Additionally, 1 subject allocated to oxytocin did not receive allocated intervention due to parent declining to participate.
732606|NCT01624168||
732607|NCT01624142|Participants were enrolled at 43 centers in Canada, South Africa, Czech Republic, Netherlands, USA, France, Spain, Italy, Belgium, Australia, New Zealand, United Kingdom, Japan, Israel, Greece, Lebanon, Brazil, and Hong Kong between 01 June 2012 and 19 March 2015.|"A total of 246 participants enrolled directly in Study 20110271 and 54 participants rolled over from Study 20110233 (NCT01588496).
~Results are reported separately for participants with homozygous familial hypercholesterolemia (HoFH) and non-HoFH severe familial hypercholesterolemia (FH) (ie, all those not meeting the protocol criteria for HoFH)."
732608|NCT01624090||
732609|NCT01623869||
732610|NCT01623830||
732611|NCT01623752|Participants those who were recruited despite of an unknown or unclear disease diagnosis, were only included in safety analysis for the study, not for efficacy evaluation.|
732612|NCT01623739||
732719|NCT01615484||Lungs were recovered from 35 NHBDs, 22 had EVLP. Two lung blocks were judged suitable, but not transplanted: No consented recipient available for #1, protocol time specifications could not be met for #2. As such, no subjects enrolled into EVLP arm.
732720|NCT01615367||
732613|NCT01623596|"62 Fingolimod arm participants discontinued: 57 discontinued before treatment switch, and 5 discontinued after treatment switch
~100 MS-DMT arm participants discontinued before treatment switch: 57 discontinued before treatment switch, and 43 discontinued after treatment switch"|"Patient disposition was summarized on the Randomized Set.
~Randomized Set (RS): consists of all participants who were assigned randomization numbers."
732614|NCT01623531|The investigation included 62 patients (>18 years old) for elective, high-risk cardiac surgery (double procedures (aortic valve replacement (AVR)+coronary artery bypass grafting (CABG), mitral valve repair/replacement (MVR)+CABG, AVR+MVR), redo-sternotomies, and aortic root repair±AVR) with a pre-operative fibrinogen level of ≤3.8 g/L.|
732615|NCT01623479||
732616|NCT01623466||
732617|NCT01623323||
732618|NCT01623310||
732619|NCT01623271||
732620|NCT01623167||Recruitment has yet to be completed for the Extension Cohort, which was added to better assess the secondary endpoints
732621|NCT01623154||
732622|NCT01623115|The study was conducted at 89 centers in 14 countries. A total of 597 participants were screened between July 2012 and April 2013, 111 of whom were screen failures.|Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, intensity of statin treatment & geographic region. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in 1:2 (placebo:alirocumab) after confirmation of selection criteria. 486 participants were randomized.
732623|NCT01623050||
732624|NCT01623037||
732625|NCT01622699||
732626|NCT01622673||
732627|NCT01622660|Protocol Open to Accrual 06/14/2012 Protocol Closed to Accrual 02/05/2014 Primary Completion Date 02/03/2016 Recruitment Location is the medical clinic|
732628|NCT01622569||
732629|NCT01622543||6 patients were enrolled in a safety run-in phase of the study before randomized component was started. These 6 patients were not included in the final analysis.
732630|NCT01622348|This was a multicenter study conducted at 13 study centers in the Unites States (US).|48 patients met inclusion/exclusion criteria; 4 were not randomized. The reasons for not randomizing these patients were: 2 patients withdrew consent, 1 whose calcium levels did not meet the criteria for randomization, and 1 for whom the study was closed prior to randomization
732631|NCT01622296|20 healthy pediatric volunteers were recruited at one U.S. clinical site. All participants completed both study interventions.|
732632|NCT01622257|"252 women were assessed for eligibility 54 women were excluded
~Not meeting inclusion criteria (n=38)
~Declined to participate (n=9)
~Other reasons (n=7)"|
732633|NCT01622231||Participants who met the inclusion criteria at Visit 1/1A entered a Screening Period (Visit 1 to 2). Participants who met the eligibility criteria for randomization entered the Treatment Period (Visit 2 to 5), during which they received GW685698X 55 micrograms (µg) once daily (QD) for a period of 12 weeks.
732634|NCT01621880||
732635|NCT01621802|Subjects were enrolled in 3 sub-cohorts. Sub-cohort 1: Inv_MMR_CO and Com_MMR_CO (Lot 1 or Lot 2), Sub-cohort 2: Inv_MMR_I and Com_MMR_I (Lot 1 or Lot 2) and Sub-cohort 3: Inv_MMR_S and Com_MMR_S (Lot 1 or Lot 2).|4011 subjects were enrolled in the study with 4007 eligible subjects receiving a study vaccination.
732636|NCT01621776|The study was conducted at the Florida Camp for Children & Youth with Diabetes during the summers of 2011 and 2012. In the summer of 2012 an additional arm was added to the study to include Novolog.|There were 107 participants consented to the study. 8 participants were withdrawn prior to randomization to the study.
732637|NCT01621737||The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
732638|NCT01621672||
732639|NCT01621633|Participants received the study treatment according to the population subset that was defined based on the severity of hepatic impairment and healthy volunteers: Group 1, subjects with mild hepatic impairment; Group 2, subjects with moderate hepatic impairment; Groups 3 and 4, healthy volunteers matching to Groups 1 and 2, respectively.|
732640|NCT01621542||please note that there were two subjects that never received study drug medication
732641|NCT01621490||227 participants were enrolled; 55 did not enter the treatment period: 41 did not meet study criteria; 6 other; 5 withdrew consent; 1 adverse events; 2 deaths. 172 entered the treatment period.2 were not treated;1 received ipilimumab monotherapy prior to the closure of Arm C; 1 received an unplanned treatment;168 were treated
732642|NCT01621477|Thirty four participants were enrolled at St. Jude Children's Research Hospital between August 2012 and November 2014.|Of the 34 participants enrolled on the study, 17 were donors. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
732643|NCT01621230|A total of 1,013 women met the study inclusion criteria between September 7, 2009 and July 16, 2012 at Parkland Hospital. A total of 481 women were consented to participate in the study, and 310 women were randomized to receive the allotted study drug. The remaining women delivered without receiving an epidural.|171 women delivered prior to randomization at 8 cm cervical dilation.
732644|NCT01621191|Participants who completed the 15-week treatment in the preceding study F1J-JE-HMGZ (HMGZ) (NCT01552057) were enrolled in this study.|Enrolled participants who completed the 50-week treatment period were considered to have completed the study. After study completion or early discontinuation, participants completed a 2-week taper and were observed 1 week post-treatment for safety.
732645|NCT01621178||This was a parallel-arm, non-inferiority study. Study treatment continued for up to 52 weeks and participants were randomized in a 1:1:1 ratio to one of the 3 treatment arms: 1.5 milligrams (mg) dulaglutide once-weekly , 0.75 mg dulaglutide once-weekly, or insulin glargine once-daily.
732646|NCT01621126||
732647|NCT01621009|Participants recruited from Madison, WI area through TV, radio, newspaper advertisements from January, 2001 to October 2002|Participants were 1) phone screened, 2) invited to group orientation where signed consent was obtained, and 3) completed CO testing and office visit for physical exam. Participants were considered enrolled after passing all 3 steps and randomization occurred at enrollment.
732648|NCT01620983||
732649|NCT01620762||
732650|NCT01620593||
732651|NCT01620567||
732721|NCT01615328||
757939|NCT00185692||
757940|NCT00185679||
732652|NCT01620528|After completing the Treatment Period, participants (who were eligible and provided consent) entered a separate continuous-use extension study (Study M12-667, NCT01760954).|Participants who prematurely discontinued from study drug and those who declined to participate in or who did not qualify for the continuous-use extension study, except for those who became pregnant, could elect to enter the Post-Treatment Follow-Up (PTFU) Period within this study for up to 12 additional months.
732653|NCT01620489|This trial was conducted in France, Poland, Russian Federation, Ukraine, United Kingdom, and the United States of America.|
732654|NCT01620255||Two (2) subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead and were counted under that group. The numbers Started reflect the number of participants who received treatment.
732655|NCT01620177||
732656|NCT01620138||
732657|NCT01620086||
732658|NCT01620060|Total subjects randomized was 105. Total subjects with PK data was 102.|
732659|NCT01620047|This was a prospective, randomized, double-blinded study performed between April and November 2011. Patients were recruited in the pre-operative clinic 3 to 7 days prior to undergoing a total knee replacement.|
732660|NCT01619982||
732661|NCT01619878|"The participant that did not complete in the 6 week follow-up phase was also included in Follow-up at 12 Months of Age and was lost to follow-up"|
732662|NCT01619852||
732663|NCT01619800||
732664|NCT01619787|Recruitment in the Western New York Area targeted primary household grocery shoppers through the local community during 2011-2013.|Interested eligible participants were screened and offered to start the study.
732665|NCT01619774|Recruitment Period: September 28, 2012 to October 23, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the 28 participants screened, five (5) were not eligible following enrollment thus were excluded prior to treatment assignment.
732666|NCT01619579|The design and the associated protocols were approved by the Institutional Review Boards of the University of California San Diego and the U.S. Department of Veteran Affairs. Pre- and post-treatment evaluations were conducted at the UCSD Pain Medicine Clinic in San Diego, CA.|Participants enrolled were diagnosed with FMS according to the 2010 ACR diagnostic criteria and were advised to refrain from stopping, changing, or starting any new treatment programs other than the study intervention. Patients who recently started, stopped, or changed pain or mood treatment were ineligible to enroll until three months had elapsed.
732667|NCT01619423||186 participants were enrolled and 186 started the study, however, two patients had too high basal manganese levels (detected after first treatment cycle) and were excluded from further treatment (screening failures) but are part of the safety population. 184 patients are part of the treatment population (11 in part 1 and 173 in part 2)
732668|NCT01619410||
732669|NCT01619085|This was a prospective, open-label extension trial in which patients with Idiopathic pulmonary fibrosis (IPF), who had completed 52 weeks of treatment and the follow-up period of the randomised, double-blind, placebo-controlled parent trials.|Treatment received in parent trials was unknown until completed and databases had been locked and unblinded. Patients were to receive nintedanib 150 mg unless they had reduced the trial drug dose to 100 mg in the parent trials, patients receiving 100 mg trial drug at the end of the parent trials could receive either nintedanib 100 mg or 150 mg.
732670|NCT01619059|Of 315 participants randomized, 298 completed Short-Term (ST) treatment period. Of 297 participants entered Long-Term (LT) treatment period, 280 completed.|
732671|NCT01618968|Subjects were screened and enrolled at 4 sites in the US. Approximately equal number of subjects on 10 mg, 15 mg, 20 mg and 25 mg doses were recruited. The dose group was determined by the Investigator based on subject's current therapeutic regimen of MTX and disease status. The subject's dose was the same for the entire study|MTX was administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C within the same dose group. Treatments were administered at a 7 day interval (On study days 1, 8 and 15)
732672|NCT01618955|Subjects were screened & enrolled at 8 sites in the US. There were 20 subjects in 10mg, 30 subjects in 15mg, 31 subjects in 20mg and 20 subjects in 25mg dose group. The dose group was determined by the Investigator based on subject's current therapeutic regimen of MTX and disease status. The patient's dose was the same for the entire study.|All patients received standardized subcutaneous self-injection training per Instructions For Use, then demonstrated the self-injection procedure with practice device and completed the training confirmation questionnaire. And then the subjects were allowed to self-administer the study dose via Vibex MTX.
732673|NCT01618942|From June 2012 to December 2012, 100 health students were recruitmented in the Tongji Medical College, Huazhong University of Science&Technology, Wuhan China.|There was no significant events and approaches for the overall study.
732674|NCT01618916||
732675|NCT01618864||
732676|NCT01618838||
732677|NCT01618708|The study was conducted at 42 centers in the US and Canada. A total of 1113 participants were screened between 05 September 2012 and 21 November 2014.|Of 1113 screened participants, 33 were re-screened, 357 were randomized and 741 were screen failures. Screen failures were mainly due to inclusion criteria not met and exclusion criteria met.
732678|NCT01618695|Participants took part in the study at 119 investigative sites in Australia, China, Korea, Japan, Malaysia, Taiwan, and Thailand. A total of 940 participants were enrolled and screened, of which 230 were screen failures, 710 were randomized in Core Phase of study.|This study included a Core Phase and an Extension Phase. This result summary includes data only for the Core Phase of the study at the primary completion date (15 September 2014). Extension Phase results will be provided upon study completion.
732679|NCT01618669|This study was conducted at 49 sites in a total of 3 countries including the United States (44 sites), Argentina (4 sites) and Peru (1 site).|At Baseline, patients meeting all inclusion/exclusion criteria completed single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) while at rest. Participants then underwent a Bruce or modified Bruce exercise protocol; those unable to reach 85% maximum predicted heart rate and/or 5 metabolic equivalents were randomized.
732722|NCT01615263|From April to October 1st 2012, 111 patients were assessed for inclusion criteria. 71 patients were not included and 40 were enrolled at their pre-operative visit to the thoracic surgery department.|No enrolled patient was excluded from the study prior to the randomization.
732723|NCT01615198||
732724|NCT01615029||
732725|NCT01614912||
732680|NCT01618422|All consecutive patients suffering from tuberculosis (TB) of aged 18 years or older with past history of TB treatment of at least 1 month within 5 years and diagnosed with a new episode of sputum smear-positive pulmonary TB requiring treatment were recruited after informed consent.|Altogether 391 patients were assessed and after excluding those who did not meet inclusion criteria or refused to participate in the study, 225 patients were successfully randomized into DOTS (n=114) and DOTS plus (n=111).
732681|NCT01618344||
732682|NCT01618305|IMPAACT P1081 (protocol version 2.0) enrolled participants from September, 2013 through November, 2014. Enrollment under NICHD P1081 (protocol version 3.0) resumed in July 2015 and continued through February, 2018. Participants enrolled at sites in Argentina (2), Brazil (7), South Africa (1), Tanzania (1), Thailand (3), and the United States (5).|Participants were randomized 1-to-1 to Arm A (efavirenz) or Arm B (raltegravir) with stratification by gestational age at enrollment (20 to <28 weeks; 28 to <31 weeks; 31 to <34 weeks; 34 to <37 weeks) and NRTI backbone (lamivudine/zidovudine or alternative, locally-supplied NRTI regimen), and dynamic balancing by study site.
732683|NCT01618266||
732684|NCT01618240||
732685|NCT01618227||
732686|NCT01618214|Subjects were recruited from 23 sites in 1 country.|Eligible subjects were randomised in a 1:1 manner to one of the 2 treatment groups.
732687|NCT01618162|The trial was conducted at 77 sites in 7 countries: Bulgaria (7), Canada (9), Germany (6), India (6), Israel (7), Turkey (3), United States (39).|The trial included a 2 week screening period to assess subject eligibility.
732688|NCT01618019|Patients with rheumatoid arthritis diagnosed based on American College of Rheumatology guideline were recruited from Hanyang university hospital in Seoul, Eulji university hospital in Daejun, Catholic university hospital in Daegu, and Maryknoll medical center in Busan between Dec 2010 and Dec 2011.|Patients receiving NSAID, glucocorticoids, or DMARD were eligible if the dosage had been stable for at least 3 months prior to entering the study.
732689|NCT01617967|A total of 29 subjects were enrolled|
732690|NCT01617681|Overall, 156 patients were screened, of which 127 patients were enrolled in the double blind period 1 of the study. A total of 120 patients (94.5%) completed Period 1 and entered Open Label Period 2.|Parallel= Period 1 (Double Blind phase) Single= Period 2 (Open Label phase)
732691|NCT01617668|215 patients were randomized to receive the study treatment. 105 gene expression signature positive patients were randomized to LCL161+paclitaxel (N=51) or paclitaxel only (N=54). 110 gene expression signature negative patients were randomized to LCL161+paclitaxel (N=55) or paclitaxel only (N=55).|Only 50 of 54 pts in the Paclitaxel without LCL161 (Positive group) received study drug; Only 53 of 55 pts in the Paclitaxel without LCL161 (Negative group) received study drug.
732692|NCT01617655|The study was conducted at 33 centers in 5 countries. A total of 206 participants were screened between June 2012 and May 2013, 99 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.|Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke, and intensity of statin treatment. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:2 ratio (placebo:alirocumab) after confirmation of selection criteria. 107 participants were randomized.
732693|NCT01617629|Participants with ovarian cancer who participated in CAN-003 [NCT01068509] and had disease progression were enrolled in CAN-003x in Australia and the United States from December 2011 to April 2014.|
732694|NCT01617603|62 subjects were recruited. The intention-to-treat (ITT) set comprised of all the subjects who completed V4. One subject joined another trial after recruitment while two other subjects dropped out in course of the trial. These three subjects were not included in the full analysis population. Finally, PP dataset comprised of n = 48.|Two subjects withdrew their consent quickly after giving it and were replaced so that the total number of recruited subjects was 62. Patients were randomly assigned to one of the three groups using age and gender as the stratification factors. The randomization was performed using the software TRIALSYS (developed internally at Nestlé).
732695|NCT01617577||
732696|NCT01617460||
732697|NCT01617447||
732698|NCT01617434|The trial was conducted at 76 sites in 9 countries i.e. 3 sites in Argentina; 9 sites in Canada; 5 sites in Finland; 9 sites in Germany; 9 sites in India; 2 sites in Mexico; 7 sites in Netherlands; 3 sites in Serbia; 29 sites in United States.|
732699|NCT01617421||
732700|NCT01617369||
732701|NCT01617187||"One participant randomized to asenapine 2.5 mg BID did not receive study drug but was recorded in clinical database as completing the study. In Participant Flow table, this participant is presented as Not Completed in period Randomization through Start Treatment (Not Treated)."
732702|NCT01617148||
732703|NCT01617083||
732704|NCT01617070||
732705|NCT01617005||
732706|NCT01616953||
732707|NCT01616771||
732708|NCT01616693|Potential participants for this study lived in the area surrounding the Christian Medical College (CMC) in the town of Vellore, Tamil Nadu, India. Parents were contacted through the existing Demographic Surveillance System shortly after the child's birth. Procedures were conducted in the Chinallapuram Field Clinic.|
732709|NCT01616576|Investigators recruited study subjects from their clinic practice. Subjects were randomized to either Group A or Group B at the time of the baseline visit. First patient first visit occurred on May 25, 2012 and last patient last visit occurred on September 07, 2012.|
732710|NCT01616459|953 subjects were enrolled in the study, among whom 951 received at least one dose of study vaccine, while 2 were allocated a subject number but did not receive any study vaccine dose.|Study vaccines were administered as a 3-dose primary vaccination in healthy infants between 6-12 weeks (42-90 days) of age at the time of the first vaccination (Primary Phase), and then as an additional booster dose when subjects reached 12-15 months of age (Booster Phase).
732711|NCT01616173||
732712|NCT01616160||
732713|NCT01616082||Overweight/obese participant were recruited to the study to participate in a 28 day low calorie diet (LCD). After 28 days, participants were evaluated for whether they met their expected weight loss targets. If participants met their targets they continued the LCD for a further 28 days and are defined as Overweight/Obese With no Drug. If participants did not reach their weight loss target they continued with LCD with an addition of phentermine and are defined as Overweight/Obese With Phentermine
732714|NCT01616056||
732715|NCT01615939||
732728|NCT01614847|A convenience sample of 8 subjects was recuitted from among the student population at the NSU Oklahoma College of Optometry during May-June 2012.|Subjects were assigned random ID numbers in preparation for assignment into the two groups. Half (4 subjects) chosen at random, would be assigned to Group 1, and receive Drop A on Day 1, then return 24 hours (Day 2) later to received Drop B. The other 4 subjects would be assigned to Group 1, and receive Drop B on Day 1 and Drop A on Day 2.
732729|NCT01614821||
732730|NCT01614795||The analysis strategy for secondary outcome measures accommodates the possibility that the Progression-Free Interval and IHC could have different statistical characteristics across the different histologies that define the study groups.
732731|NCT01614769||
732732|NCT01614743||
732733|NCT01614613||
732734|NCT01614600|Participants were recruited from 8 study centers located in the United States.|Of the 91 participants enrolled, 3 were exited as screen failures prior to dispensing of the study product. This reporting group includes all enrolled and dispensed participants.
732735|NCT01614574||
732736|NCT01614509|Conditions: Macular edema secondary to Branch Retinal Vein Occlusion The recruitment period: from Jan 2012 to Aug 2012|During the follow up period, Not attendants, participants who were received other intraocular surgeries and etc. were excluded.
732737|NCT01614470||
732738|NCT01614457||A total of 70 subjects were randomized, of which 1 subject discontinued the study prior to study drug administration. A total of 69 subjects started treatment.
732739|NCT01614392||
732740|NCT01614249|Women who met the trial inclusion criteria were recruited from clinic registers at their respective Prevention of mother-to-child transmission program clinics from July 2012 to May 2013 with assistance from mentor-mothers in the clinics. Women visiting the clinics first time were included in clinic registers and invited to participate in the trial.|Participants were assigned to either of the trial arms soon after enrollment to minimize drop-outs which might have occurred if enrolled participants exceeded gestation age or gave birth before randomization.
732741|NCT01614210||
732742|NCT01614093||17 participants were randomized, 16 participants participated in the trial. All data is available for only 16 participants
732743|NCT01613768|Seattle Cancer Care Alliance/University of Washington Phase II open label study enrolled patients at a single site between May 2012 and August 2015.|Twenty-nine patients were consented and treated.
732744|NCT01613716||
732745|NCT01613599|A total of 100 participants were enrolled in 15 investigational sites in United States. 3 participants out of 100 enrolled participants were not included in the analysis population as that site became unresponsive.|
732746|NCT01613417|A total of 229 patients were recruited from September 2012 through November 2013 at 19 clinical trial sites. Off-site assessment of the images was performed between 21 January and 3 April 2014 by 3 board-certified neuroradiologists blinded as to which contrast agent was used, patient clinical information, and the results of other imaging studies.|229 patients were enrolled and signed informed consent. Each enrolled patient was randomized and dosed with at least one contrast agent.
732747|NCT01613378||
732748|NCT01613339|Data collection was performed in the following order due to practical reason at four primary health care centres in Örebro county council; Kumla Primary health care center, October 2011- January 2012, Karla Primary health care centre, March 2012-June 2012, Nora and Brickegården Primary health care centre September 2012 to December 2012.|
732749|NCT01613326|A total of 980 patients were screened, and 657 were randomized (327 to NVA237 and 330 to tiotropium).|Patients meeting the eligibility criteria were randomized to receive NVA237 50 μg o.d. or tiotropium 18 μg o.d. in a 1:1 ratio. Patients were stratified according to their smoking status (current / ex-smoker).
732750|NCT01613313|Subjects were screened and enrolled at 1 site in the United States|
732751|NCT01613248||
732752|NCT01613222|The first subject was enrolled on June19, 2012 and the last subject was enrolled on February 15, 2013. The study was conducted at Clinimark, a human performance laboratory that tests physiological monitoring devices.|
732753|NCT01613131|Women were recruited from the University of Colorado Denver campus by direct physician referral or from advertisements in the University community.|Women using systemic hormonal contraception (patch, pill, ring) were required to have a 30 day hormone washout prior to placement. One subject signed the consent, but failed to meet the inclusion/exclusion criteria during the screening process. Thus, there were 39 women that were enrolled, but only 38 that started in the participant flow.
732754|NCT01613027||
732755|NCT01613014||
732756|NCT01612884||67 subjects were enrolled and underwent testing on day 0. Only 37 of those subjects underwent PCI, and therefore were randomized to either LTA or TEG guided intervention arm. The remainder of subjects were treated medically without PCI or were referred for CABG (see flow diagram in protocol) and did not get randomized to any intervention arm.
732757|NCT01612858||
732758|NCT01612793||
732759|NCT01612780||
732760|NCT01612767||
732761|NCT01612702|305 patients who were scheduled for unilateral total knee arthroplasty at Seoul National Bundang Hospital from April 2011 to December 2011 were recruited.|14 patients were excluded before assignment. 5 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 4 had serious medical conditions such as renal failure, heary failure, 5 refused to participate
732762|NCT01612676|The patients were recruited at the respective intensive care units at four centers (3 in Belgium and 1 in Denmark) between 05 Jul 2012 to 15 Nov 2013.|Of the 159 patients screened, 31 patients were randomised and 30 patients were dosed. One patient in the 3.75 ng/kg/min dose group did not receive any study treatment due to an adverse event (elevation of troponin) recorded prior to infusion.
732763|NCT01612546||
732764|NCT01612494|Participants were recruited over the course of one year from a single center's pediatric emergency department|No enrolled patients were excluded from the trial
732765|NCT01612351||
732766|NCT01612221||
732767|NCT01612156||
732768|NCT01612000||
732769|NCT01611974||
732770|NCT01611948||
732771|NCT01611935||
732772|NCT01611883||
756957|NCT00276549|Patients were recruited from July 2004-October 2006 from medical clinic.|
732773|NCT01611857|Between January 2012 and March 2014, 49 patients were enrolled at multiple centers in the U.S. Fifteen patients with advanced solid tumors were enrolled in the dose escalation phase, and 34 patients with first-line metastatic cancer of the esophagus, gastroesophageal (GE) junction, or stomach in the expansion phase.|Forty-nine patients were enrolled; 47 were treated. Two participants withdrew prior to dosing. 15 participants were enrolled and treated in the dose escalation phase. 34 participants were enrolled in the dose expansion phase; however only 32 were treated. Patients continued treatment until disease progression or intolerable toxicity.
732774|NCT01611792||
732775|NCT01611779||
732776|NCT01611662||
732777|NCT01611571|beginning 12/23/2003 and ending 11/2008 a total of 31 participants were enrolled in this study.|
732778|NCT01611558||40 participants enrolled and treated
732779|NCT01611298||
732780|NCT01611259|50 patients were enrolled at 4 sites in Austria. First patient in was 06-Jun-2012; Last patient in was 26-May-2014.|2 patients were withdrawn before first response evaluation and were replaced. 2 patients withdrew their consents prior to study treatment and did not experience AEs to other study procedures. These 2 patients were therefore excluded from intent-to-treat (ITT) efficacy assessments, safety assessments and listing of baseline characteristics.
732781|NCT01611194|Participants were recruited from military sites from Sept 2012 to May 2014.|
732782|NCT01611155||
732783|NCT01611090||A total of 578 participants were enrolled in the study. Among these, 289 participants were randomized in each ibrutinib + bendamustine/rituximab (BR) treatment group and placebo+BR treatment group.
732784|NCT01610791||
732785|NCT01610752||
732786|NCT01610713||
732787|NCT01610700||
732788|NCT01610687||
732789|NCT01610596|"Recruitment period: November 2011 to February 2012
~The location of clinical sites included dermatology clinical research centers."|All subjects who met the entry criteria were randomized and enrolled into the study.
732790|NCT01610570||The study was closed to enrollment before dose level I was completed and hence no patients were enrolled on other dose levels.
732791|NCT01610557||56 participants enrolled: 50 participants had one eye randomly assigned (unilateral participants) and 6 participants had two eyes enrolled (bilateral participants) for a total of 62 eyes analyzed at baseline. Bilateral participants had the right eye randomly assigned; the left eye assigned to the group with the schedule inverse to the right eye.
732792|NCT01610492|Eligible participants were recruited from July 2012 until March 2014, into this 2 part study of a initial treatment phase, a long term treatment phase, and then followed up for a further 6 months. Results have previously been presented for the initial treatment phase, up to the Week 28 and are now presented for the completed study.|Screening occurred within 35 days and no less than 14 days before the first scheduled study treatment dose. Total 21 participants were screened; 14 were randomized and entered the initial treatment phase while 11 participants entered the long-term treatment phase. Common reasons for screen failures were insufficient, or improvements in proteinuria.
732793|NCT01610453|Recruitment was from 1. January 2012 until 30. April 2013|
732794|NCT01610427||Of 31 subjects registered in the study, 9 subjects were screen failures and 22 subjects were enrolled in the study.
732795|NCT01610414||Some of the enrolled subjects were allocated subject numbers, but were not administered all doses of study vaccine, hence they did not start the study.
732796|NCT01610297||
732797|NCT01610284|This study was conducted at 274 centers in 29 countries worldwide (Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Republic of Korea, The Netherlands, Peru, Poland, Russia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, UK and USA.).|Approximately 1200 patients were planned to be enrolled in the study. A total of 1147 patients were randomized and analyzed (576 in the buparlisib + fulvestrant and 571 in the placebo + fulvestrant arm). Not completed: in Randomization Phase=Randomized and not Treated; in Treatment Phase=Discontinued study treatment per Protocol.
732798|NCT01610271||
732799|NCT01610167|327 subjects queried from Investigator database following IRB apprvoal on 14-Sept.-2011. 199 of the queried subjects were consented and screened. 161 subjects were accepted at screening and appointed for baseline visit 2 weeks later. 159 subjects were evaluated at the baseline exam and 151 subjects were randomized and enrolled into the study.|10 subjects were lost following screening and at baseline assessment. 5 of the 10 were disqualified due to insufficient tactile response, 3 due to lack of evaproative hypersensitivity, and 2 had scheduling conflicts.
732800|NCT01610154|Sitagliptin 100 mg QD for 12 weeks and followed-up every 4 weeks|
732801|NCT01610076||
732802|NCT01610063|This study was conducted at Franciscan Skemp Hospital in La Crosse, Wisconsin, a member of the Mayo Clinic Health System.|233 male and female patients between the ages of 18 and 80 years with a primary DSM-IV diagnosis of major depressive disorder or depressive disorder not otherwise specified (NOS) were approached for consent. 3 patients refused consent. 3 participants failed to meet eligibility criteria.
732803|NCT01610037|A total of 2064 patients were screened, of whom 1216 patients were randomized to QVA149 110/50 µg o.d., tiotropium 18 µg o.d., or placebo. Of the 1216, one patient was randomized but not treated.|One patient of the 1216 was randomized but did not receive treatment
732804|NCT01610011||
732805|NCT01609933||The study included a 42-day screening period.
732806|NCT01609842|Participants were enrolled January 2014-March 2017 at 15 VA cardiac catheterization laboratory sites in 4 waves according to the study design protocol|The participants reported in the Control Arm/Group were all unique patients; they were assigned as follows: pre-intervention control (n=6,081), post-intervention control (n=2,917), and concurrent intervention controls (n=4,869); there was no overlap between the control groups.
732807|NCT01609790||
732808|NCT01609582|Participants took part in the study at 469 investigative sites in 31 countries; 192 sites in North America, 175 in the Europe, Middle East, and Africa (EMEA) region (including Russia, Ukraine, Israel, and South Africa), 65 in the Asia Pacific region, and 37 in Latin/South America from 01 June 2012 to 05 May 2014.|Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM) and clinically-evident cardiovascular (CV) disease or multiple risk factors for CV events who were inadequately controlled while receiving the standard of care were enrolled in 1 of 2 treatment groups: placebo; fasiglifam 50 milligram (mg).
732813|NCT01609257|Participants took part in the study at 5 investigative sites in the United States from 16 June 2012 to 18 March 2014.|Healthy Volunteers were enrolled equally in 1 of 2 treatment groups, Norovirus Bivalent VLP Vaccine or Placebo.
732814|NCT01609231|The trial was halted prematurely for business reasons.|
732815|NCT01609062||
732816|NCT01609023||
732817|NCT01609010||
732818|NCT01608971||
732819|NCT01608815|The study participants were enrolled from 26 May 2012 to 31 August 2012 at 4 clinic centers in Japan.|A total of 200 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
732820|NCT01608724|This study was conducted at 92 study centers in China. First subject enrolled: 28 Nov 2012; Last subject last visit: 16 May 2014.|A total of 2165 patients were screened and 741 patients were excluded due to violation of any inclusion and exclusion criteria.
732821|NCT01608672||Eligible patients were identified by retrospective chart review. Demographic and Outcome Measure data were collected at a study visit on Day 1 (approximately 4-28 weeks following last treatment) for patients who received treatment with BOTOX® for ≥5 years. Adverse Event data was collected by retrospective chart review.
732822|NCT01608659||In this retrospective chart review study, subjects received botulinum toxin Type A (BOTOX®) in study-defined Treatment Periods 1 and 3, and botulinum toxin Type A (Xeomin®) in Treatment Period 2. Data were evaluated as available for each Treatment Period.
732823|NCT01608490||
732824|NCT01608321||
732825|NCT01608308|Recruitment is completed.|
732826|NCT01608295|Single site outpatient clinic in the U.S.|208 volunteers were assessed for eligibility, of which 100 declined to participate and 37 did not meet inclusion criteria. Seventy-one persons consented to participate, of which 65 passed screening and were enrolled; nine of 65 enrolled participants withdrew before randomization.
732827|NCT01608100||
732828|NCT01608087|This was a randomized, single-blind, single-dose, parallel-arm, active comparator, Phase I clinical trial. The trial was planned to be conducted in two stages and subjects were to be randomly allocated in each stage. Based on the interim analysis finalized on 18 February 2013, the trial was closed after Stage 1, and Stage 2 was not conducted.|Subjects were randomized in a 1:1:1 ratio to receive BI 695502, United States (US)-licensed Avastin® or European Union (EU)-approved Avastin®.
732829|NCT01608061||
732830|NCT01607957|This was a multicenter study conducted in 101 study centers in 13 countries including the United States, Japan, Spain, Italy, Germany, Belgium, France, Australia, United Kingdom, Austria, Ireland, Sweden, and Czech Republic.|Total 1002 participants provided consent, out of which 800 participants were randomized in 2:1 ratio in TAS-102 and placebo treatment groups respectively.
732831|NCT01607853|Start date: 28-Jun-2012 Completion date: 15-Oct-2012|Prior to randomisation, the subjects entered a washout phase (if required) where antipsoriatic treatment and other relevant treatments had to be discontinued as defined by the exclusion criteria. Depending on prior use of disallowed treatments, the washout phase could last for up to 21 days.
732832|NCT01607658||
732833|NCT01607645|Participant were enrolled between 8/23/12 and 5/16/13 at the FHCRC|
732834|NCT01607593|Data were collected from the medical records of participants with post-traumatic stress disorder (PTSD) who have been dosed with sertraline since July 2006 (i.e., the start of marketing of this drug in Japan) or later. Treatment with sertraline had to be initiated before the conclusion of the contract with investigational sites.|In this retrospective investigation, 123 patients were enrolled, but it was found during the data screening that one patient was not actually diagnosed with PTSD, and this patient was excluded from the investigation. Thus, 122 patients became subject to the investigation.
732835|NCT01607554||
732836|NCT01607476|Participants were recruited from Mayo Clinic in Minnesota.|89 subjects were consented, but 1 subject was a screen failure prior to assignment.
732837|NCT01607450||
732838|NCT01607411|Participants were recruited at the clinical site.|Of the 70 participants screened, 15 were not randomized into the study (12 did not meet study criteria and 3 withdrew the consent). A washout fluoride (F) toothpaste was used for a week prior treatment. In-situ appliances were prepared for participants to fit enamel specimens.
732839|NCT01607398|Japanese participants with Chronic Obstructive Pulmonary Disease (COPD) were enrolled in this study.|At Visit 1, participants meeting the inclusion criteria and not meeting any of the exclusion criteria entered a 4-week Run-in Period. At the end of the Run-in Period (Visit 2), eligible participants were randomized to a 12-week Treatment Period.
732840|NCT01607346|This was a multicenter, open label study to examine the effect of ezogabine/retigabine added to existing anti-epileptic drugs on the voiding function of adult participants with drug-resistant partial onset seizures (POS). The study was conducted in two countries: United States and France.|The study was conducted in 5 phases:Screening (Day-30 to Day-2), Baseline (Day-1), treatment (Day1-49), taper-down titration (Day 50-70). A total of 10 participants were enrolled into the study and received at least one dose of the study medication.
732841|NCT01607320||
732842|NCT01607255||
732843|NCT01607203||the Principal Investigator (PI) prescreened the patients and only the eligible patients were assigned to a group by the study coordinator
732844|NCT01607112||Approximately 50% of subjects in the Fluarix/Influsplit > 60 Years Group and a maximum of 25% of subjects in the Fluarix/Influsplit 18-60 Years Group were allowed to have had a seasonal influenza vaccination the year before.
732845|NCT01606852||
732846|NCT01606800||
732847|NCT01606787||
732848|NCT01606761||A total of 878 participants (placebo [n=294], sirukumab 50 mg every 4 week (q4w) [n=292], and sirukumab 100 milligram (mg) every 2 week (q2w) [n=292]) were randomized and included in the study.
732849|NCT01606748||Cohort 1 'completers' completed the PK run-in period (3 Weeks) and Cycle 1, Day 1 and Cohort 2 'completers' completed the PK run-in period.
732850|NCT01606735||
732851|NCT01606709||
732852|NCT01606670|The study started to enroll subjects in May 2012. Overall, 28 sites enrolled 93 patients in this study.|Participant Flow refers to the Enrolled Set (ES).
732853|NCT01606319||
732854|NCT01606306||
732855|NCT01606254||
757053|NCT00267774||
757054|NCT00267748||
732856|NCT01606228||There were 188 patients enrolled in the study which were included in the safety analysis set. The main analysis set included only 176 subjects due to 12 protocol violations. Of these 176 patients, only 73 were included in the per-protocol analysis set. For the Clinical Global Impression-Severity scores, data was collected for only 60 patients.
732857|NCT01606202||
732858|NCT01606189||
732859|NCT01606176||
732860|NCT01606150||
732861|NCT01606137||
732862|NCT01606124|The study was closed to accrual early due to a pending expiration of the supply of study agent.|
732863|NCT01606007||"Of 1282 participants enrolled subjects, 534 eligible subjects entered the randomized, double-blind treatment period.
~Of 534 randomized and treated subjects, 490 subjects completed the study."
732864|NCT01605942|This study was terminated due to corporate decision and enrollment was not completed.|
732865|NCT01605916|First patient enrolled on 01 June 2012. Last subject last visit on 30 March 2015.|Out of 33 enrolled subjects, 25 subjects were assigned to selumetinib (AZD6244, ARRY-142886), and 8 subjects were not assigned. The reasons of no assignment were 'Screen failure' (7 subjects) and 'Withdrawal by subject' (1 subject).
732866|NCT01605903|741 patients were enrolled between May 3, 2012 and January 20, 2017 at participating institutions (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center San Diego, San Diego; Naval Medical Center Portsmouth, Portsmouth; and Madigan Army Medical Center, Tacoma) prior to surgery.|All enrolled subjects were randomized to a treatment group, however 53 (7.2%) patients did not receive the study medication , either because they dropped out prior to the first dose of study medication, the procedure was cancelled, alternative surgical technique was used, pharmacy error, or IV acetaminophen was administered.
732867|NCT01605890|The study enrolled ART-naïve adults infected with HIV-2 only with history of CDC group B or C event, or a CD4 count <500 cells/μL, or a CD4 decrease >50 cells/μL/year over the past 3 years, or a confirmed plasma HIV-2 RNA (pVL) ≥100 copies (cp) /mL from 18 hospital centers in France.The last participant completed in December 2015.|Of the 38 participants screened between July 2012 and January 2015, 30 (78.9%) participants were finally included.
732868|NCT01605877|Subjects were recruited from 2 study sites located in Japan.|Of the 70 subjects enrolled, 6 were discontinued prior to first implantation due to withdrawn consent (1) and meeting exclusion criteria (5). This reporting group includes all implanted subjects (64).
732869|NCT01605825||
732870|NCT01605799||
732871|NCT01605669||
732872|NCT01605617||
732873|NCT01605552||
732874|NCT01605539||
732875|NCT01605461||
732876|NCT01605435|Study participants were recruited from community dwelling adults meeting study criteria expressing interest in participating in research studies at University of Pennsylvania.|Dose finding with each participant receiving placebo at their first study visits and three escalating doses of ghrelin, separated by 3-7 days in visits 2,3 and 4.
732877|NCT01605396||Of 196 screened participants, 80 were randomized to either ridaforolimus plus dalotuzumab plus exemestane or ridaforolimus plus exemestane.
732878|NCT01605370||
732879|NCT01605292||
732880|NCT01605227|First patient enrolled: 02 July 2012 (first subject randomized), Data cut off date: 07 July 2014|
732881|NCT01605136||
732882|NCT01605032||
732883|NCT01605019||
732884|NCT01604941||The study started as a double-arm study with once daily (QD) dosing but was amended first to a double-arm study with twice daily (BID) dosing and then to a single-arm study after removing the higher dose. Some participants were enrolled directly to BID dosing, some to QD dosing and then re-enrolled to BID dosing, some completed with QD dosing.
732885|NCT01604850|Subjects were enrolled in a total of 57 study sites in the United States, Canada, and New Zealand. The first participant was screened on 04 June 2012. The last participant observation was on 08 May 2013.|277 participants were screened and 202 were randomized. Of those participants randomized, 201 received at least one dose of study drug, and comprise the Safety Analysis Set; 195 of those participants with genotypes 2 or 3 HCV infection were treated and comprise the Full Analysis Set.
732886|NCT01604824|This study was conducted at 4 sites, 3 in France & 1 in the United States. Twenty-eight participants were screened between Feb 2012 & Apr 2013. A total of 23 participants were enrolled: 13 in cohort 1 & 10 in cohort 2. Recruitment for cohort 2 occurred after the un-blinding of cohort 1 & analyses of the double-blind study data for cohort 1.|Eligible participants entered a 2-wk, single-blind, placebo run-in period. Participants in cohort 1 were randomized in a 1:1 ratio (group A or B); Participants in cohort 2 were also randomized in a 1:1 ratio (group C or D).
732887|NCT01604785||
732888|NCT01604772||
732889|NCT01604408||
732890|NCT01604343||A total of 2746 participants were screened of which 1670 participants were randomized and received at least one administration of study treatment.
732891|NCT01604291|The study was conducted at 21 investigational centers in Israel.|The study was consisted of 3 arms of treatments: 1. Dual therapy: Peginterferon alfa-2a & Ribavirin; 2. Triple therapy :Peginterferon alfa 2a & Ribavirin & Telaprevir; 3. Triple therapy: Peginterferon alfa 2a & Ribavirin & Boceprevir
732892|NCT01604278|The number of patients randomized was 449. Of these participants, the Full Analysis Set (FAS) comprised 446 participants who received at least one dose of study drug and had no major deviations which led to removal from the FAS. The Safety Set included 447 participants who received at least one dose of study drug.|
732893|NCT01604265||
732894|NCT01604122||
732895|NCT01604109|The study took place in the central part of Thailand, where water [F]<0.1 ppm. The recruitment began in June 2010. There were 304 healthy Thai boys and girls from ten public nursery schools enrolled in the study. The baseline examination was performed at school in July-August, 2010.|Six children were excluded from the study because they did not complete the inclusion criteria: autism (1), milk protein allergy (1), taking fluoride table (1), and no high caries risk (3).
732896|NCT01603940||
732897|NCT01603875|We recruited 66 subjects from Faculty of Veterinarian, Chulalongkorn University. The recruitment held between June 25, 2012 and July 2, 2012. Others 39 subjects was recruited from Faculty of Veterinarian, Mahanakorn University of Technology.|
757055|NCT00267696|February 2006 through August 2010|
732898|NCT01603641||Pediatric participants with lower limb spasticity who were previously treated with BOTOX® in study 191622-111 [NCT01603628] and de novo participants received up to 5 BOTOX® treatments in this study.
732899|NCT01603628||Pediatric participants with lower limb spasticity were randomized 1:1:1 to one of three treatment groups: BOTOX® 4 or 8 U/kg (unit per kilogram) or placebo.
732900|NCT01603615||Pediatric participants with Upper Limb Spasticity who were previously treated with BOTOX® in study 191622-101 [NCT01603602] and de novo participants received up to 5 BOTOX® treatments in this study.
732901|NCT01603602||Pediatric participants with upper limb spasticity were randomized 1:1:1 to one of three treatment groups: BOTOX® 3 or 6 U/kg (unit per kilogram) or placebo.
732902|NCT01603459|The clinical study was conducted at 30 sites located in Canada, France, Germany, Italy, Norway, Portugal, Spain, and the United States of America.|
732903|NCT01603420||
732904|NCT01603394|A total of 24 participants were screened, of which nine participants at five study centers in the following four countries: Austria (2), Germany (1), South Africa (1) and USA (1) were enrolled and received at least one dose of pregabalin during the study.|This was a Phase 4, open-label, pilot study of pregabalin and prediction of treatment response in post herpetic neuralgia (PHN) participants. The duration of the treatment period was 6 weeks (4 weeks dose optimization +2 weeks fixed dose), with a 1-week taper/placebo washout administered at the end of study.
732905|NCT01603368|Extremely preterm infants with a birth weight <1000 g were recruited within 72 hours after birth in two level 3 NICUs .|Inclusion should be completed to allow first dose of study product to be administered within 72 hours from birth.
732906|NCT01603355||
732907|NCT01603277|25 July 2012 - 09 June 2013|
732908|NCT01603121||
732909|NCT01603082|Participants recruited from 15 actively participating sites in the United States of America, from July 2012 until June 2014.|Overall, 343 participants were screened; 102 met inclusion/exclusion criteria, 100 were randomized. 96 participants completed treatment and 97 participants completed the study.
732910|NCT01603056||
732911|NCT01603043|Participants were recruited from 7 study centers located in the United States.|
732912|NCT01602965||
732913|NCT01602744|"Data were collected on April 2012 from 382 residents' records in Givaat Hashlosha geriatric facility.23 residents were excluded for not fulfilling study entry criteria. The final study group was comprised of 359 residents. 359 residents were randomized on May 2012 to recieve either STOPP/START screening (N=183) or usual care (n=176)."|23 residents were excluded: 10 were younger than 65 years of age, one was not taking medications, 5 had a terminal illness and 7 had been on a short stay in the facility.
732914|NCT01602731|This project was opened for recruitment as of July 1, 2012. Enrollment for the study originally took place in the heart failure (HF) clinic and Investigator's circle of confidentiality, but after poorer than anticipated enrollment, screening was expanded to all outpatients at the VALLHS with a diagnosis of HF.|
732915|NCT01602692|female candidates presenting for bilateral breast reduction at the University of Wisconsin ambulatory surgery center performed by a single surgeon (Dr. Rao)|
732916|NCT01602679||12 subjects enrolled in this study. 5 subjects completed screening procedures only (these 5 subjects were withdrawn from study prior to being assigned to an arm of intervention).
732917|NCT01602666|Patients enrolled on the study from 05/29/2012 to 11/01/2016 on Stratum 1 and from 05/29/2012 to 10/26/2018 on Stratum 2|There were 111 patients enrolled in Stratum 1 with localized nongerminomatous germ cell tumors (NGGCT) and 151 patients enrolled in Stratum 2 with localized CNS Germinoma (Germinoma). Of these 107 in Stratum 1 and 137 in Stratum 2 were deemed eligible for the study. This report is limited to eligible subjects.
732918|NCT01602614||
732919|NCT01602562||
732920|NCT01602549||The study consisted of a Screening/Baseline Period, a Treatment Period, and a 14-day post-treatment safety Follow-up Visit. Participants were randomized to receive GSK962040 50 milligrams or placebo in a 2:1 ratio; one participant was randomized to receive GSK962040 125 mg.
732921|NCT01602510|The study consisted of 4 phases: screen phase (<2 weeks[W]), open-label phase (OLP) (Up to 16 W, lamotrigine monotherapy (LM) or combination therapy escalated to a target dose of LM 200 milligrams [mg]/day[D]), randomized double-blind phase (RDP) (up to 36 W, lamotrigine 200 mg/day or placebo) and follow-up visit (14 days after the last dose).|420 participants entered into OLP and received at least one dose of study medication. Of these 420 participants, 264 were randomized into RDP.
732922|NCT01602484|During a six-month period from November 2011 to May 2012, fifty patients met inclusion criteria, 29 females and 21 males. Twenty-five patients were randomized to each group. The subjects were patients of the Brigham Foot and Ankle Clinic and had surgery performed at Faulkner Hospital in Boston, MA.|No enrolled patients were excluded from study or excluded from assignment to groups.
732923|NCT01602471|Five participants enrolled, four complete and one withdrawal prior to receiving the investigational product. Study was terminated early by the sponsor.|
732924|NCT01602419||
732925|NCT01602380|First patient enrolled: 17 October 2012; last patient enrolled: 11 July 2014; data cut-off for the primary analysis: 11 April 2016. Patients were randomised to study treatment study at 113 centres in 20 countries. Results data presented up to the primary analysis cut-off date only.|524 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all inclusion and none of the exclusion criteria. 62 patients were not randomised, mainly due to eligibility criteria not being fulfilled (44/62 patients) or patient decision (13/62 patients). 462 patients were randomised to receive treatment.
732926|NCT01602341||
732927|NCT01602315|45 patients enrolled in Phase Ib, 106 cetuximab naïve patients in Phase II were randomized to either BYL719+cet (N=71) or cet monotherapy (N=35). Of the 35 patients, 16 crossed over to BYL719+cet combo treatment. 29 patients enrolled in the non-randomized combo treatment arm (cet resistant patients). All patients have completed the trial.|One patient was prematurely randomized at the site but was never treated.
732928|NCT01602224||Completers are defined as participants who died or had disease progression or completed treatment or did not complete treatment and were followed for survival data.
732929|NCT01602198||
732930|NCT01602172|Recruitment occurred December 2012 to June 2014 on three medical-surgical units at the VA Pittsburgh Healthcare System.|Not applicable; no enrolled participants were excluded from the trial prior to randomization.
732931|NCT01602120|This study enrolled eligible patients who had completed the 18-month treatment period of Study NCT01229215 (CFD4870g) or the 24-week treatment period of Study NCT02288559 (GX29455). The study was terminated early by the Sponsor due to lack of efficacy.|
732932|NCT01602068|Male or female patients at least 12 years of age and undergoing unilateral cataract surgery with implantation of a posterior chamber IOL could be screened|1:1 randomization
732933|NCT01602016||The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.
732934|NCT01601977|Patients approached in ventilation clinic and assessed for trial participation. Patients were recruited and scheduled for trial initiation. Once 10 patients completed the study protocol the remaining recruited patients did not start the assessment period.|
732935|NCT01601873||103 were enrolled, but only 97 started (a difference of 6 subjects). These 6 subjects who were enrolled but did not start the study presented to the day-surgery operating room but had not followed instructions to stop Coumadin; therefore, their cases were cancelled.
732936|NCT01601847|Infants were recruited from participating NICUs, special care nurseries, and well-baby nurseries.|If all eligibility labs were not available from routine clinical care, parents were consented prior to obtaining the remaining eligibility labs. If those post-consent laboratory results made the infant ineligible, they were not randomized.
732937|NCT01601821||
732938|NCT01601782|Patients who are referred for an ultrasound of the extremity will be asked to participate in the study.|
732939|NCT01601704||
732940|NCT01601691||
732941|NCT01601626|Study participants were recruited at 9 sites from 5 countries (2 each from Brazil, Haiti, Peru, and South Africa and 1 from Kenya) between July 2013 and February 2016.|
732942|NCT01601535||
732943|NCT01601496|Subjects were referred to and treated at 10 vascular surgery centers in Germany and Austria. Enrolled subjects received a FUSION Vascular Graft between October 2009 and May 2012.|Patients were enrolled if they had peripheral artery occlusive disease (PAOD), signed informed consent forms, received subject numbers, and were screened for inclusion in the study. One subject failed to meet all eligibility criteria, prior to implantation of a FUSION vascular graft, and was not included in the efficacy or safety analyses.
732944|NCT01601470||
732945|NCT01601431||
732946|NCT01601236|Initial recruitment target was 40 subjects.|Adaptive design mandated closure of groups 5 & 6 with re-assignment of subjects to groups 3 & 4 if pre-defined tolerability criteria were met in 2 of first 6 patients.
732947|NCT01601132|Participants took part in the study at one investigative site in the USA from 11 June 2012 to 01 July 2012.|Thirty non-smoking, adult male and female volunteers (ages 18 to 45 years) were enrolled in this single group study.
732948|NCT01601067|Participants contacted our study in response to 1) flyers posted in VA mental health, primary care, and alcohol and substance use treatment programs; 2) from advertisements in print and web-based media; and 3) by VA primary care, SAMI, PTSD, and other psychiatry clinics|Enrolled participants were excluded from the study for the following reasons: 27 did not meet inclusion criteria; 15 did not complete intake or did not return for intake following informed consent;5 refused research after consent; 2 had travel or logistical constrains.
732949|NCT01600950||This was a randomized, 2-period, 2-sequence, crossover study.
732950|NCT01600885||
732951|NCT01600729||
732952|NCT01600716||
732953|NCT01600703|Local newspaper advertisement|21 participants were enrolled in the study, however only 15 were started.
732954|NCT01600677|During the study period, between May 15, 2012 and March 1, 2013, potentially eligible subjects were recruited at UPMC Presbyterian and UPMC Passavant Hospitals. Study eligibility was determined by electronic medical record review and bedside assessment.|
732955|NCT01600638||
732956|NCT01600586||PI has left Vanderbilt, data obtained from publication http://pediatrics.aappublications.org/content/133/3/462.full
732957|NCT01600495|A randomized, controlled clinical noninferiority with an evaluator blind, comparative analysis of a study group and a control group, this estdo includes 46 patients, was developed in the Reference Center for Women's Health in Ribeirão Preto, São Paulo state Brazil, during the period September 2011 to February 2012 .|283 women in labor were eligible, women were excluded because they did not participate 237 the inclusion criteria (first pregnancy, the position of a single fetus head, above 37 weeks, 4-5 cm of cervical dilatation, spontaneous onset of labor, not use of medications during the study period, intact membranes, and not associated with risk factors).
732958|NCT01600482||As per agreement with FDA, following the 207 patient 6F Celt ACD study, an additional 34 patients were recruited across 3 clinical investigation sites whereby a 7F Celt ACD device was used to close an arterial puncture made with a 7F sheath in fully anti-coagulated patients. 7F device approval is pending with FDA.
732959|NCT01600326||
732960|NCT01600287|51 patients assessed in surgical ward between january 2012 to september 2012, after excluding 11 patients, 40 remaining patients were randomised into two groups(IAADS & Manual) of 20 each- all patients in each group received allocated interventions- no patients needed to be excluded from final analysis.|5 patients were initially excluded because of having cyanotic heart disease, 6 patients excluded subsequently as they resisted pre-induction venous cannula placement.
732961|NCT01600222|First Subject First Visit: 4-Jun-2012 Last Subject Last Visit: 2-May-2013|"Subjects with extensive psoriasis vulgaris of at least moderate severity (according to the Investigators Global Assessment of Disease Severity; IGA) on the trunk, limbs and the scalp were enrolled.
~Screening: normal HPA axis function before and after ACTH-challenge test and albumin-corrected serum Ca lvl below the upper normal limit were required."
732962|NCT01600170|Chronic HIV infected individuals on HAART (with no changes in treatment within 4 weeks of study entry), were recruited using the Penn CFAR Clinical Core database. Subject were consented by the study nurse coordinating the project. Of 46 screened subjects, 11 fulfilled the inclusion criteria and were enrolled in the study.|Participants that met the inclusion criteria were randomly assigned to 12weeks of atorvastatin (or placebo) in the first period followed by a 4week washout and then in the second period on placebo (or atorvastatin) for 12 weeks followed by washout (4weeks). Therefore each subject served as their own control.
757941|NCT00185640||
757942|NCT00185614||
732963|NCT01600105|Recruitment began in May 2010, with enrollment from October 2010 through February 2017. Patients were recruited from the Division of Liver Diseases or from the Surgical Oncology Clinic at Mount Sinai.|
732964|NCT01600092||A total of 1039 participants were screened
732965|NCT01600053||
732966|NCT01600014|First Subject First Visit: 04-Jun-2012 Last Subject Last Visit: 05-Feb-2014|A total of 463 subjects were enrolled, 13 of whom were screening failures. 450 subjects were allocated to open label treatment with ingenol mebutate gel (1st cycle) and subsequently administered a 2nd cycle in a randomised vehicle controlled setting, if eligible for repeat use
732967|NCT01599832||
732968|NCT01599806||The results presented in these forms represent the combined data base of the two identical protocols D4280C00002 and D4280C00004. The protocol D4280C00002 has a total of 522 randomized patients and the protocol D4280C00004 has a total of 511 randomized patients which adds up to a combined total of 1033 patients.
732969|NCT01599793||
732970|NCT01599754|A total of 128 study sites in 9 countries randomized 724 participants into this study.|
732971|NCT01599741|The enrollment of patients occured between July 3 and October 12, 2012|
732972|NCT01599650||
732973|NCT01599637||
732974|NCT01599585||
732975|NCT01599325||
732976|NCT01599234||
732977|NCT01599104|The study consisted of 3 epochs: 1)screening, 2) single blind run-in and 3) double blind treatment. During the run-in epoch, eligible participants received placebo to both treatments for 2 to 4 weeks. After the run-in epoch, a total of 1161 eligible participants continued into the double blind treatment epoch for 8 weeks.|
732978|NCT01598987||"Overall 62 patients were screened prior to the data monitoring committee (DMC) recommendation to terminate enrolment.
~Six patients were screen failures. The other 56 patients were included and treated."
732979|NCT01598922||Healthy control subjects were not part of the clinical trial (they were not assigned to treatment).
732980|NCT01598896|7 subjects were randomized for this study out of 12 subjects who were screened for this DCCS study at McLean Hospital|5 subjects that were screened were not randomized. 1 subject stopped using MJ between the screening visit and baseline visit and was thus withdrawn, 2 subjects were no longer interested in the study after screening visit, 1 subject entered in-patient treatment before randomization and 1 screened subject did not meet DSM criteria for MJ dependence
732981|NCT01598831|This study was conducted at 319 sites in 27 countries; of these, 159 study sites (in 26 countries) assigned participants to study drug treatment. First participant was randomized on Oct 29, 2012 and the last participant was randomized on Mar 8, 2018. Last participant completed long term follow-up (survival only) on Feb 28, 2019.|Of 946 consented participants, 816 randomized to study treatment, 800 received at least 1 dose of study treatment.
732982|NCT01598779||
732983|NCT01598753|Participants with fibromyalgia (FM) were enrolled at 2 sites, the University of Washington in Seattle WA and the University of Rochester in Rochester NY.|Participants underwent a physical exam to rule out conflicting medical conditions and confirm a diagnosis of FM (1990 ACR criteria). A 5-day baseline diary was distributed and required a mean daily pain score ≥ 4 and ≤ 9. A urine drug test with no illicit drugs and a negative urine pregnancy test (when applicable) were also required at baseline.
732984|NCT01598740|The first subject was enrolled on 01 June 2012 and the last subject completed on 06 August 2012. The study was completed at one research center.|Each study period included a 5-day baseline period followed by a 7-day treatment period. The study periods were separated by a 7-day washout period.
732985|NCT01598701||
732986|NCT01598662||
732987|NCT01598610||
732988|NCT01598545|Subjects enrolled from January 2013 to June 2014 at Grady Memorial Hospital.|
732989|NCT01598532|Recruitment for the study began in April 2010. Potential subjects were recruited through several different methods - Spaulding Rehabilitation Hospital outpatient clinic, advertisements in local area newspapers, Brain Injury Association of MA and other area organizations that provide services to TBI survivors, flyers, on-line and social media.|22 study subjects signed the consent but only 11 completed the study. The 11 that did not completed the study either did not meet the inclusion criteria at Screening or were lost to follow-up after they screened for the study.
732990|NCT01598506|Subjects enrolled from January 2013 to November 2013|
732991|NCT01598428||
732992|NCT01598350|Subjects were recruited from local elementary schools from November 2009 until January 2009|
732993|NCT01598311|This study enrolled adult participants with Clostridium Difficile associated diarrhea (CDAD) at 104 study centers in North America, Asia-Pacific, and South America.|
732994|NCT01598298||
732995|NCT01598207||
732996|NCT01598194|60 consecutive participants referred for diagnostic EUS-FNA of suspected solid pancreatic mass on CT imaging, recruited from February 2012 to July 2013, underwent 2 passes with a standard 25G needle for cytologic analysis, and were randomized, 30 per group, to undergo 2 passes with 22Gpc (1 pass each for cytology and histology), using SST or CST.|
732997|NCT01598129||
732998|NCT01598090||Out of 881 participants who were enrolled, 648 were randomized and only 644 were treated. 27 participants were treated in Part A and 617 participants were treated in Part B of the study.
732999|NCT01598064||
733000|NCT01598025||
733001|NCT01597908||Participants (par.) were stratified for lactate dehydrogenase (LDH) and BRAF mutation (V600E versus V600K). Par. were randomized in a 1:1 ratio to receive either dabrafenib and trametinib combination therapy or vemurafenib until disease progression, death, or withdrawal.
733002|NCT01597856|Post 9-11 era Veterans with an initial PTSD Compensation & Pension Application scheduled were recruited from VA Connecticut Healthcare System and TN Valley Healthcare system between April 2013 and July 2016.|All enrolled Veterans completed study assessments at baseline, week 4 and week 12. Only Veterans with self-reported risky alcohol use or use of an illicit drug within the last 28 days were randomized to receive SBIRT counseling or No additional counseling conditions.
733003|NCT01597843|We recruited 12 posts at the outset of the study, with the help of the Legion's state leadership. We invited all post members to complete surveys at times 0, 5 months and 10 months. The surveys were distributed by post leadership at a post meeting. We did not obtain informed consent; we obtained no personal identifiers but we obtained post.|
733005|NCT01597687|The duration of enrolment of all subjects was less than a year. Each subject attended one study visit at the time of enrolment, during which Quality of Life (QoL) and Health Economics (HE) questionnaires were administered and one blood sample was drawn.|A total of 337 subjects were enrolled into this study, but only 312 had valid laboratory results. 2 subjects were excluded due to vulnerable conditions, 16 subjects were excluded due to protocol violation and 7 subjects were excluded due to vaccination with pertussis vaccines within 1 year before blood sample collection.
733006|NCT01597635|This study was conducted across 5 centers in United States and 5 centers in Canada from 20 September 2012 to 06 October 2014.|A total of 46 participants were randomized for this study of which 44 participants (5 participants in Part A and 39 participants in Part B) received at least one dose of study medication.
733007|NCT01597622|This was multicenter, open-label continuation study of belimumab plus standard of care (SOC) in Systemic Lupus Erythematosus (SLE) participants who completed study BEL113750 (NCT01345253) in Northeast Asia (Japan and Korea) & participants who completed the open-label extension of C1115 (NCT01484496) in Japan to assess long term safety & efficacy.|Total 143 participants were screened for this study and 142 participants were enrolled and received study treatment in current study. BEL113750, a 52 week double-blind study; C1115, a 52 week double-blind study followed by a 6 month open-label extension.
733008|NCT01597596|The study was conducted between 21 August 2012 and 1 December 2014.|A total of 5 participants were screened and 4 participants were treated.
733009|NCT01597557||Some patients enrolled in the study and received the study drug but did not undergo the cardioversion procedure due to various reasons
733010|NCT01597505|Males and females aged 18 years or older with diarrhea at risk for Clostridium Difficile Associated Diarrhea (CDAD) were enrolled in this study|
733011|NCT01597492|Eligible participants with systemic lupus erythematosus (SLE) were randomized in 7:9 ratio to receive pneumonococcal vaccination either 4 weeks prior (early cohort) or 24 weeks after (late cohort) their first belimumab dose of 10 milligram (mg)/kilogram (kg) intravenously (IV).|A total of 79 participants were enrolled, of which 34 were randomised to the early cohort and 45 were randomized to the late cohort. All randomized participants received at least 1 dose of vaccine and/or belimumab and were included in the Intent-to-Treat (ITT) Population.
733012|NCT01597479|Between february 2010 and april 2014, we enrolled 52 patients scheduled for elective ambulatory TRA under rutine axillary braquial plexus block.|
733013|NCT01597440||
733014|NCT01597388|"One hundred ten (110) patients enrolled in the study; 100 patients were assigned to a treatment schedule and 10 patients were screen failures. One patient withdrew from the study prior to receiving study drug and was excluded from the safety analysis set.
~Patients were treated at 5 sites in the US from 21 May 2012 until 4 August 2016."|
733015|NCT01597375|A total of 51 potential participants were screened at Brigham and Women's Hospital.|46 of whom underwent randomization per protocol, and 40 of whom completed the trial and were analyzed.
733016|NCT01597258||
733017|NCT01597245||This study has 5 periods: Period 1 - Screening; Period 2 - Blinded Induction Dosing Period (Weeks 0 to 12); Period 3 - Blinded Maintenance Dosing Period (Weeks 12 - 60); Period 4 - Long-Term Extension Period (Weeks 60 - 264); Period 5 - Post-Treatment Follow-Up Period (A Minimum of 12 Weeks)
733018|NCT01597193||Stage 1: Included participants with incurable breast cancer. Stage 2: Included participants with hormone receptor-positive incurable breast cancer.
733019|NCT01597141||
733020|NCT01597128|All subjects were identified in the Minimally Invasive Surgery Clinic at the University of Kentucky Medical Center. Recruitment started in March of 2011 and ended in May of 2014|
733021|NCT01597050||
733022|NCT01596972|Recruitment period: July 2012-March 2013 Outpatient clinic|
733023|NCT01596842||
733024|NCT01596751||
733025|NCT01596699||
733026|NCT01596582||
733027|NCT01596504|The study was conducted at 8 centers in Germany between 22 May 2012 to 25 July 2013.|A total of 236 participants were screened and 142 participants were randomized and treated.
733028|NCT01596335||
733029|NCT01596283||
733030|NCT01596231||
733031|NCT01596127|Recruitment: 1/24/2013 through 11/13/2013. All participants recruited at The University of Texas MD Anderson Cancer Center.|Four patients were enrolled and three participants were evaluable for safety and efficacy and toxicity. One patient was ineligible and therefore was never treated. Due to lack of response and slow accrual, the study was terminated early.
733032|NCT01596088||
733033|NCT01596062|With premature end of recruitment only 16 patients were included. Descriptive analysis was done & statistical method fitted the small number of patients. One final analysis was performed at M6 post-transplantation & comprised assessment of criteria planned at M3 and M6. Some analysis pertaining to the secondary objectives were not performed.|
733034|NCT01595854||
733035|NCT01595646||
733036|NCT01595529||Of the 717 enrolled, 23 did not meet the screening criteria and 1 withdrew consent prior to randomization. 693 subjects were randomized.
733037|NCT01595516||
733038|NCT01595438||The results presented in these forms represent the combined data base of the two identical protocols D4280C00002 and D4280C00004. The protocol D4280C00002 has a total of 522 randomized patients and the protocol D4280C00004 has a total of 511 randomized patients which adds up to a combined total of 1033 patients.
733039|NCT01595386||
733040|NCT01595282|"Dates of recruitment period: June 2011-May 2012
~Clinic: free-standing, outpatient health center"|
733041|NCT01595009||
733042|NCT01594970||
733043|NCT01594853||
733044|NCT01594827|The Persistent MRSA Eradication Protocol (PMEP) was a double-blind, randomized, placebo-controlled study performed at two CF centers (Johns Hopkins Hospital, Baltimore, MD; and University Hospitals Rainbow Babies and Children's Hospital, Cleveland, Ohio.) The study was conducted from October 2012 through March 2017.|After qualifying for and enrolling in the study based on inclusion criteria, participants were required to again demonstrate MRSA positive respiratory culture at the run-in visit (day -14) in order to be randomized to treatment arms. 39 participants were assessed for eligibility but only 29 matched inclusion criteria and were randomized.
733045|NCT01594762||
757943|NCT00185588||
758961|NCT00096161||
733046|NCT01594749||A total of 14 participants did not receive any study drug: 4 in the Fosaprepitant Regimen and 10 in the Control Regimen. One participant who was randomized to the Control Regimen received the Fosaprepitant Regimen.
733047|NCT01594528||
733048|NCT01594515|70 patients were treated and analysed.|Partially randomised, placebo-controlled within dose groups, single-blinded, single-centre study to assess the safety, tolerability and pk of single rising oral doses of BI 1015550(a powder for oral solution reconstituted with solvent tartaric acid and solvent component hydroxy-propyl-β-cyclodextrin (HPβCD)) in healthy male volunteers.
733049|NCT01594476||
733050|NCT01594424||
733051|NCT01594411|Subjects are enrolled at multiple participating primary care practices from site initiation (Apr-Jun 2012) thru January 2013.|327 screened, 275 met inclusion/exclusion. Subjects were excluded from the analysis set if no Corus CAD test could be resulted (7) or if additional information was available and used in making post treatment decisions (3) or did not inclusion/exclusion (discovered after research blood sample draw). Analysis set was 251.
733052|NCT01594385||
733053|NCT01594333|9321 subjects were screened and 4786 subjects were randomized starting from April, 2013 through March 2018 in 417 clinical sites in Canada and the United States|9321 subjects were screened, 2987 were found to be ineligible and 176 were discontinued due to premature trial closure prior to entering the open label run-in. 6158 started the run-in. Of those, 1171 were ineligible, 201 were discontinued due to premature trial closure and 4786 subjects were randomly assigned to either Methotrexate or Placebo
733054|NCT01594294||Of the 100 participants enrolled, 21 were exited as screen failures prior to initiation of the Investigational Phase. This reporting group includes all participants randomized into the Investigational Phase (79).
733055|NCT01594281|Patients were screened for eligibility at 23 German study sites and randomized at 22 of the 23 sites.|The number of patients in the protocol section (107) excludes one patient in the Ranibizumab mono arm who withdrew prior to the baseline visit. The number of patients in the Randomized Set (108) includes this patient. A separate Informed Consent was signed for the Non-Interventional Follow Up Phase
733056|NCT01594125||
733057|NCT01593852||
733058|NCT01593787||
733059|NCT01593748||
733060|NCT01593722|Of the155 subjects recruited, 92 were eligible for screening and signed consent. Thirty had loiasis, of which 16 were excluded because their microfilarial counts were >5000 mf/mL. One subject was excluded because of age and one declined to participate. The remaining 12 patients were enrolled in the treatment arm of the study.|
733061|NCT01593696||
733062|NCT01593670||
733063|NCT01593592|All adult dyspeptic patients presented to outpatient gastroenterology clinics of the Tropical Medicine and Internal Medicine Departments, Faculty of Medicine, Zagazig University Hospitals, Egypt from June 2012 to February 2013 were offered to share in the study|
733064|NCT01593254||262 were enrolled. 260 were randomized. 2 were not randomized due to failure to meet inclusion/exclusion criteria
733065|NCT01593215||
733066|NCT01592864|Participants were recruited at the clinical site.|Of 122 participants screened, 2 participants did not meet the study criteria, and 2 withdrew consent before randomization. 118 participants were randomized to study treatments.
733067|NCT01592851|Participants were recruited at the clinical site.|Of 126 participants screened, 9 participants did not meet the study criteria, 3 were lost to follow up and 1 withdrew consent before randomization. Remaining 113 participants were randomized to study treatments.
733068|NCT01592799|Recruitment started in October, 2010, and last until May, 2011, or until the target sample size was enrolled.|
733069|NCT01592786|Patient recruitment occurred over an eleven month period, from June of 2012 to May of 2013, at 118 study sites, located in the United States and 17 other countries.|Enrolled patients went through a 2-week screening period.
733070|NCT01592773|Patient recruitment occurred over an eleven month period, from October of 2012 to September of 2013, at 106 study sites, located in the United States and 15 other countries.|
733071|NCT01592760||
733072|NCT01592747|Patient recruitment occurred over a ten month period, from September of 2012 to June of 2013, at 92 study sites, located in the Untied States and 14 other countries.|Patients who completed at least 12 weeks of exposure to open-label memantine and met the responder criterion at 2 consecutive visits separated by at least 2 weeks during lead-in study MEM-MD-91 were eligible to enroll into this study.
733073|NCT01592708||
733074|NCT01592695||
733075|NCT01592500||
733076|NCT01592435||
733077|NCT01592409|Recruitment was by media ads and research postings in Toronto.|"Screened over the telephone n=1024. Assessed for eligibility (n=178). Excluded: Not meeting inclusion criteria n=45, Declined to participate or lost interest n=32, Did not receive IP (did not return after practice session) n=2.
~Pilots (received active cannabis, not randomized) n=5. Randomized n=94."
733078|NCT01592396|A total of 30 participants were screened, out of which 20 were randomized into the study. The reasons for screen failures were not meeting the inclusion/exclusion criteria, and/or consent withdrawal.|
733079|NCT01592383||
733080|NCT01592344||
733081|NCT01592292||The arm Other anti-TNF agent consisting of participants treated with adalimumab, etanercept and infliximab was divided into individual treatment groups only for the purpose of Participant flow reporting. All other analyses were performed in Rituximab versus Other anti-TNF agent.
733082|NCT01592240||
733083|NCT01592071|Recruitment between 2008 and 2010. Blood draws and discussion of results of blood draws performed at UM Clinical Research Building|
733084|NCT01592045||
733085|NCT01592006|Since new better drug options had became available, the intervention drug of this study was no longer the best option for the patients. Thus this study was terminated.|
733086|NCT01591954||
733087|NCT01591863||
733088|NCT01591837||
733089|NCT01591785|The study was conducted from January 2012 to August 2012, all subjects were enrolled at one site.|
733090|NCT01591746||
733091|NCT01591733||
733180|NCT01586312|30 patients were included between 26/Jul/2012 (Pat. 01) and12/Dic/2012 (Pat. 30).|All patients fulfilled the selection criteria, were randomized and received the assigned medication.
733181|NCT01586195||
733092|NCT01591681|The study was conducted at Stanford University (Stanford, CA), the Barbara Davis Center (Denver, CO), and St. Joseph's Health Care (London, ON). A total of 49 subjects were enrolled between November 1, 2012 and February 20, 2013. Forty-five participants age 15-45 years old with type 1 diabetes (median HbA1c 6.8%) completed the trial.|After the run-in phase, a 42-night randomized trial was conducted in which each night was randomly assigned to have either predictive low glucose suspend system active (intervention) or inactive (control) with half of the nights being intervention and half control nights.
733093|NCT01591655||
733094|NCT01591616||
733095|NCT01591499|Multi-center study conducted by 15 freelance opthalmologiests to enroll 180 patients.|
733096|NCT01591460||
733097|NCT01591408||
733098|NCT01591382||
733099|NCT01591317||
733100|NCT01591161||
733101|NCT01591096||1 patient was recruited for the study, however, they did not receive the intervention due to an AE
733102|NCT01591044||
733103|NCT01591018||
733104|NCT01591005||
733105|NCT01590979||
733106|NCT01590888|Twenty sites were initiated for the study, with participants enrolled at 14 sites in the US and 5 sites in Australia.|
733107|NCT01590875||
733108|NCT01590810||
733109|NCT01590797|This study was performed with research participants at 28 study centers in China.|
733110|NCT01590771|All participants randomized population.|
733111|NCT01590758|Subjects recruited at outpatient clinics and practices|No wash-out or run-in periods; eligible subjects were immediately assigned to treatment
733112|NCT01590563||
733113|NCT01590550|Pediatric patients receiving hemodialysis (HD) at a single institution during the specified study period|
733114|NCT01590433||249 subjects provided informed consent, 182 were randomized. I am reporting that 249 subjects were enrolled according to our local IRB definition of enrollment. 182 started study treatment. 67 subjects who did not start treatment were either found to be ineligible based on screening labs; withdrew consent; or were lost to followup.
733115|NCT01590394|Patients were enrolled at Mayo Clinic in Rochester, Minnesota.|
733116|NCT01590264|All subjects were recruited from Washington University Otolaryngology and Audiology clinics.|Subjects were enrolled for one pre-treatments screening visits, received two weeks of rTMS treatment, and were assessed at the last treatment day. There was no additional follow-up.
733117|NCT01590238||
733118|NCT01590212|Participants were identified by community midwifes as having additional health and social care needs in pregnancy in two locations. Recruitment took place between May November 2012.|Two participants withdrew after randomisation but before baseline data was collected. The researcher was unable to contact two further participants to collect baseline data.
733119|NCT01590082|Recruitment period: November 6, 2012 to March 30, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|
733120|NCT01590017||
733121|NCT01589978||
733122|NCT01589926|Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.|
733123|NCT01589822||
733124|NCT01589770|Participants were recruited from the Vanderbilt Rheumatology practice, responses to advertisements, and word of mouth. Exclusion criteria included estimated glomerular filtration rate of <60 ml/min and inability to undergo cardiac MRI.|
733125|NCT01589653|The trial was conducted at 18 sites in 5 countries as follows: Egypt: 4 sites, Indonesia: 2 sites, Morocco: 4 sites, Saudi Arabia: 4 sites, Vietnam: 4 sites.|The subjects continued on their previous NPH insulin and OADs upto randomisation (visit 2). At randomisation, the subjects discontinued these treatments except metformin.
733126|NCT01589601|"The duration of the intervention in PAL-HF is 6 months but patients in both groups were followed until death or until the end of the study (approximately 3.5 years). Please see the numbers completed in the Overall Study section."|
733127|NCT01589510||
733128|NCT01589497|Recruited at two AIDS Clinical Trials Units in South Africa. Recruitment occurred between June 30, 2015 (date of first participant was randomized) and January 13, 2016 (date of last participant was randomized).|69 were randomized 1:1:1:1 to 4 treatment arms. Among the 69 participants, 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
733129|NCT01589484||
733130|NCT01589445|"Location: Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM),Dhaka, Bangladesh and National Forensic DNA Profiling Laboratory, Dhaka Medical College, Dhaka.
~Recruitment of patients were started at November 2008 and ended at December 2010."|130 Type 2 Diabetes Mellitus (T2DM) out door patients of BIRDEM were screened to participate in the study.80 patients signed consent form and 77 enrolled the trial.3 patients didn't participate due to unknown cause.The patients were directed to follow their routine diet chart as before.
733131|NCT01589315||We planned to enroll up to 20 but only enrolled 17 due to time and budget issues.
733132|NCT01589302||
733133|NCT01589237||100% patients who completed the screening phase were enrolled in the study.
733134|NCT01589185|Recruitment locations: Intensive Care Units. First subject enrolled: 16-May-2012. Last subject completed: 06-Sep-2016. The study was on administrative hold from 20-Nov-2012 to 24-Dec-2014.|Eligible patients were randomized based on evidence of severe pneumonia caused by S. aureus. All patients enrolled were intubated.
733135|NCT01589094||
733136|NCT01588990||
733137|NCT01588951||
733138|NCT01588821||
733139|NCT01588561||
733140|NCT01588548||43 patients were enrolled to the study, of which 35 recieved doses of AZD1208 between 120mg and 800mg. The other 8 patients did not receive AZD1208.
733141|NCT01588509|This study was conducted at 8 centers in the United States. The first participant enrolled on 30 March 2012 and the last participant enrolled on 21 August 2012.|
733179|NCT01586338|The study was conducted at 10 centers in China. A total of 237 participants were enrolled between March 09, 2012 and February 28, 2013.|Of 237 enrolled participants 232 participants were treated. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).
733142|NCT01588496|Male and female adults and adolescents ages ≥ 12 to ≤ 65 years (≥ 12 to ≤ 80 years in Part B) with a diagnosis of homozygous familial hypercholesterolemia (HoFH) were eligible for this study. The first participant enrolled on 05 April 2012 and the last participant enrolled on 08 November 2013.|Part A was an open-label, single-arm, multicenter pilot study. Part B was a double-blind, randomized, placebo-controlled, multicenter study with expanded enrollment. In Part B participants were randomized in a 1:2 allocation stratified on the basis of screening low-density lipoprotein cholesterol (LDL-C) (< 420 mg/dL vs ≥ 420 mg/dL).
733143|NCT01588470||
733144|NCT01588457||After a washout period of up to 1 week, subjects will be openly randomized to treatment with Lithium (Li) or Divalproex (Div) for 2 weeks. Subjects who become intolerant to lithium or divalproex at any point will be crossed over to the other mood stabilizer and continued in the study, or terminate early.
733145|NCT01588444||
733146|NCT01588418||
733147|NCT01588405||
733148|NCT01588366|Study started in April, 2012 with Part A. Part B was added per protocol amendment in September, 2012.|
733149|NCT01588353|104 patients were enrolled, and 102 received AK160. This study proceeded stepwise from Step1 through Step3. First, 6 patients were enrolled in Step1 at the selected study centers, thereafter, 71 and 25 patients were enrolled in Steps2 and3 respectively at all centers. The primary endpoint was determined in 77 participants enrolled in Steps1 and 2.|
733150|NCT01588236||
733151|NCT01588197||
733152|NCT01588184||The number of participants enrolled over the planned recruitment period was open. 95 participants actually enrolled in this study.
733153|NCT01588158||
733154|NCT01588106|Subjects were screened and enrolled in 16 sites across Germany. Study start date was in June 2012 and recruitment was stopped in November 2014.|
733155|NCT01587989||The screening population consisted of men and women with mild-to-moderate active rheumatoid arthritis (RA). Pre-study methotrexate (MTX) administration for at least 12 weeks. Participants experiencing inadequate response to MTX (Disease Activity Score Based on 28 Joints Count [DAS28] 28 less than [<] 4,5 and greater than [>] 2,6) enrolled.
733156|NCT01587963||
733157|NCT01587950|Participants were recruited at the clinical site.|Prior to efficacy assessment phase of this study, commercially available dental materials were employed to develop a dental stent in 3 participants. The dental stent design created a reservoir capable of holding the test solution at the cervical margin of a study tooth for at least 10 minutes. There was no efficacy data for this development phase.
733158|NCT01587924|This study was conducted in hemodialysis-dependent (HDD) participants from 06 June 2012 till 17 June 2013 across 48 centers in the United States (US), Canada, and European Union. A total of 68 participants were planned to be enrolled.|A total of 103 participants were screened, out of which 83 participants were randomized in the study. The participants were receiving recombinant human erythropoietin (rhEPO) for 2 weeks and had hemoglobin (hgb) range of 9.5 to 12.0 gram per deciliter (g/dL); however, one participant did not receive the study drug.
733159|NCT01587898|The study was conducted at Canada, Germany, and United States between 29 May 2012 and 30 May 2013. A total of 282 participants were screened, 209 were screen failures and 73 eligible participants were randomized. Entry into the study requires a target stable hemoglobin (Hgb) of 8.5-11.0 gram per deciliter (g/dL).|Out of the 73 randomized participants, one participant did not receive any study medication. the remaining 72 participants were included in safety population. Another one participant had no post-randomization data and was excluded from Intent-to-treat (ITT) population (71 participants).
733160|NCT01587885||
733161|NCT01587703|A total 196 participants were enrolled and randomized in the Part 1 QD (65 participants), Part 1 BID (19 participants), Besylate Substudy (10 participants), and Part 2 (102 participants) groups.|This was a 2-Part study conducted in 8 countries-Part 1 (dose-escalation) and Part 2 (dose expansion). A besylate sub-study (four period, crossover) was conducted in 10 participants in the United States.
733162|NCT01587651|All subjects must have been taking low dose aspirin (ASA) (75 mg to 150 mg once daily-QD) for at least 7 days prior to Screening (Visit 1), and must have continued the same regimen throughout the study.|The study consisted of a 3 to 5 day ticagrelor run-in phase followed by randomized treatment on 1 of 2 prasugrel regimens or continued ticagrelor
733163|NCT01587274||
733164|NCT01587118||
733165|NCT01587105||
733166|NCT01587079|The study was conducted at 20 sites in the US from May 2012 until September 2012. The entire study was scheduled to take a maximum of 19 weeks for each individual subject.|Study was a chronic dosing (7 days), 4-period, 8-treatment, Incomplete Block, Cross-Over.
733167|NCT01587040|The study was conducted at 21 centers in 4 countries between 20 July 2012 and 23 May 2018. Participants who received SAR245408/SAR245409 (IMP) in parental studies (TED12471 [NCT01596270], ARD11437 [NCT01082068], TED12863 [NCT01943838]) were included in study. A total of 67 participants were screened and 61 participants were enrolled in this study.|Participants who received IMP for <2 cycles in parental study, and participants who took a daily dose of IMP higher than their established dose entered treatment-extension study on Day 1 of initiation period; participants who received IMP >=2 cycles in parental study entered treatment-extension study on Day 1 of extension period.
733168|NCT01587027|The study proposed to randomize approximately 24 subjects to complete 16.|A total of 26 subjects were screened and consented. Of the subjects assessed, 21 (81%) passed and 5 (19%) were screen failures. Of those subjects who were screen failures, 3 (60%) had abnormal lab results and 2 (40%) had scheduling difficulties.
733169|NCT01587014||
733170|NCT01587001||
733171|NCT01586975|Patients with cerebrovascular disease and taking one or more antiplatelet medication were consented for study participation from 2007 though 2010. Patients were recruiting on the inpatient stroke unit at Northwestern Memorial Hospital and seen in the outpatient stroke clinic.|
733172|NCT01586962|Study Start/End Dates 07 May 2012 to 17 May 2012|
733173|NCT01586910||
733174|NCT01586897|Primary Care Physicians were recruited and randomized to intervention or control arms, but data were collected and analyzed for the patients of the Primary Care Physicians.|
733175|NCT01586819||
733176|NCT01586806||
733177|NCT01586741||
733178|NCT01586364||
733182|NCT01586156||
733183|NCT01586091||
733185|NCT01585987|Acceptable first-line chemotherapy before randomization to this study for a participant was a regimen containing a fluoropyrimidine agent and a platinum salt. Study initiated July 2012. Primary endpoint July 2014. Study completed April 2015.|114 enrolled and randomized. 29 enrolled but not randomized to treatment group: 26 no longer met study criteria; 2 withdrew consent, 1 other.
733186|NCT01585961||
733187|NCT01585779||
733188|NCT01585766|This study was conducted from 30 Jul 2012 to 20 Jun 2016 in United States, Poland, Spain, and Ukraine.|A total of 56 participants were screened in this study. Out of which 28 participants were enrolled and randomized into the study.
733189|NCT01585597||
733190|NCT01585584|It was hoped that 21 patients with chronic HCV genotype 3 who had failed to achieve an SVR with a standard course of treatment with Peginterferon α + ribavirin (PR) would be selected from the University of Calgary Liver Unit (UCLU) database. 11 patients were able to be enrolled in the study.The last patient completed the study in December 2014.|Of the 11 patients who were enrolled in the study, 1 patient was a screen failure.
733191|NCT01585558||
733192|NCT01585441||
733193|NCT01585428||
733194|NCT01585324||This clinical trial was originally planned to be conducted in 4 clinical trial centers in the Czech Republic. However, due to failure in manufacturing of the drug Pegasys, 3 of the previously approved study centers withdrew from participation. Consequently, the sponsor decided to conduct the clinical trial in 1 of the 4 originally planned centers.
733195|NCT01585298||6998 participants were enrolled into the study and were considered as part of the safety set, but 2 participants discontinued from the study and did not take any study drug.
733196|NCT01585272|Patients receiving Exelon patch 5 cm^2 were more than those receiving Exelon capsule for 4 weeks as least, because some patients had interrupted Exelon capsule for few days in the middle of 4-week Exelon capsule treatment, but still switched to Exelon patch 5 cm2|
733197|NCT01585246||
733198|NCT01585207||
733199|NCT01585194||The accrual goal and dates were updated to match the new statistical design 10/2017.The enrollment changed to 39 participants. A total of 67 participants signed consent, 39 participants entered the study to participate in the trial in its current form w/combination metastatic therapy. 28 patients entered the study in its previous form when it was an adjuvant trial and then subsequently a monotherapy metastatic trial, and they are inevaluable for reporting results of the study in its current form
733200|NCT01585168|82 participants were screened for eligibility and then were consented at the Olin Research Center. However, after consent and prior to group randomization, 11 participants were excluded from the study due to follow-up eligibility paperwork (i.e. psychiatric interview, family history review, etc.) for a total of 71 randomized.|
733201|NCT01585155||
733202|NCT01585129||
733203|NCT01585038||
733204|NCT01585025||
733205|NCT01584843|The study consisted of a Screening Period (1-2 weeks), the First Treatment Period (12-52 weeks), and the Second Treatment Period (24 weeks). In this summary, data are presented for participants who completed Week 24 of the First Treatment Period.|A total of 41 participants with horizontal strabismus meeting the selection criteria were divided into two strata in terms of the mean of the distant-view strabismus angle and the near-view strabismus angle in the primary position: >=10 prism dioptre (PD) to <20 PD as Strata 1 and >=20 PD to <50 PD as Strata 2.
733206|NCT01584648|Participants (par.) with advanced or metastatic (Stage IIIc or Stage IV) BRAF V600E/K mutation-positive melanoma were enrolled in this randomized, double-blinded, multi-center Phase III study.|
733207|NCT01584609||
733208|NCT01584544||
733209|NCT01584518||
733210|NCT01584479|From 25,452 individuals meeting inclusion criteria, 9,927 (0.39 of eligible) consented to participate, and 5,117(0.515 of consented) returned completed questionnaires and were successfully genotyped.|
733211|NCT01584388||
733212|NCT01584232||
733213|NCT01584024|Caries-active volunteer cadet-candidates and cadets, at high risk for caries disease, were recruited at United States Military Academy in West-Point, New York (USA).|Paired, split-mouth study design: Each patient received 2 paired treatments (one of each arm). Eligible tooth pairs were selected for similarity. Random allocation of treatment to study lesions per tooth pair.
733214|NCT01583985||25 patients withdrew prior to randomization. 10 were excluded by the study team and 15 declined to be randomized.
733215|NCT01583894||
733216|NCT01583868|This was a randomized, bilateral, study, with a crossover at one week and a second crossover at two weeks. A total of 216 subjects (432 eyes) were enrolled in this study. Participants were randomized to receive either, the Test Lens C, Test Lens D and PureVision2 lenses, or the Test Lens C, Test Lens D and Air Optix Aqua lenses.|
733217|NCT01583686||All reporting groups are in the Phase I portion of the study because the study was terminated before reaching phase II.
733218|NCT01583647||MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042;NCT00461630) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
733219|NCT01583543||
733220|NCT01583530||
733221|NCT01583452|Our study included 5-18 years old patients with gastrointestinal surgery from two institutions (Hospital San José Tec de Monterrey and Hospital Regional Materno Infantil); during April to August 2012. However, because the most common diagnosis in this group of age was appendicitis, only patients with this condition were included at the end.|Initially our study was focused on patients who had gastrointestinal surgery, however, the main diagnosis of our population of interest was appendicitis; and those children with other diagnosis did not meet the criteria for including them in the study. This way, our final population was children who underwent open or laparoscopic appendectomy.
733222|NCT01583374|The study enrolled participants at 88 study sites and in 18 countries (Australia, Austria, Bulgaria, Czech Republic, Estonia, France, Germany, Hungary, the Netherlands, Poland, Romania, Russia, Slovakia, Spain, the United Kingdom, Canada, Sweden, and the United States [US]).|"Randomized participants were stratified by the following 2 parameters:
~C-Reactive Protein (CRP) concentration (normal: ≤ 1.5 mg/dL or elevated: > 1.5 mg/dL) at screening;
~The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score < 6.0 or BASDAI score ≥ 6.0 at baseline."
733223|NCT01583218|First patient was enrolled on 3/29/2012 and last patient completed the study on 1/15/2016. Patients meeting the inclusion and none of the exclusion criteria at screening were randomized 1:1 to either the betrixaban or enoxaparin treatment group.|To maintain the blind, patients either received betrixaban capsules for 35 to 42 days and daily subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days, or received daily SQ injections of enoxaparin for 10 ± 4 days and betrixaban placebo capsules for 35 to 42 days.
733224|NCT01583179||
733225|NCT01583166|"Subjects with stress incontinence or stress-predominant mixed urinary incontinence who were scheduled to undergo a retropubic midurethral sling with no concomitant procedures at UMass Memorial Healthcare, Inc.
~Enrollment occurred from March 2012 to June 2015 with study presented and consent sought at time of preoperative appointment."|10 participants did not receive allocated intervention--patient-initiated cancellation of surgery. (Saline + Epinephrine n=6, Bupivavane + Epinephrine n=4). Midway through study, indigo carmine became unavailable and surgical team opted for phenazopyridine. Failed to obtain 6-7 hour pain score in 24 out of 80 subjects.
733226|NCT01583101||While physicians were the ones that received prompts, the prompts are the unit of analysis.
733227|NCT01582971||
733228|NCT01582945|Patients were referred to the study by their primary psychiatrists and no compensation was provided for participation.|Subjects underwent a psychiatric screening evaluation, physical exam, EKG, laboratory testing, and a urine screening for substances of abuse to determine study eligibility.
733229|NCT01582880||
733230|NCT01582854|Participants took part in the study at 33 investigative sites in Belarus, Kazakhstan and Russia from 28 June 2012 to 26 November 2014.|Participants who had suffered ischaemic stroke were enrolled equally in 1 of 2 treatment groups, actovegin 2000 mg solution (up to 20 infusions) followed by 200 mg tablets 3 times a day or placebo.
733231|NCT01582789||
733232|NCT01582490||
733233|NCT01582477||
733234|NCT01582451||
733235|NCT01582308|Each treatment sequence started with 2 participants in Period 1. In addition, there were 2 replacement participants; in treatment sequence 5, a participant who discontinued after period 1 (placebo treatment) was replaced and in treatment sequence 7, a participant who discontinued during period 1 (saxagliptin treatment) was replaced.|A washout period of at least 10 days occurred between each treatment period.
733236|NCT01582282||
733237|NCT01582243||
733238|NCT01582178|"Patients older than 18 years referred to our unit for diagnostic outpatient colonoscopy. Subjects were excluded if they has a history of colorectal surgery, known diagnosis of IBD, chronic benzodiazepine use and if they refused sedation.
~The period between June and October 2012."|Subjects were not included if they did not fulfill inclusion criteria.
733239|NCT01582152|Recruitment Period: July 24, 2012 to June 02, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.|Study was terminated early without advancing to the second portion (Phase II).
733240|NCT01582139||
733241|NCT01582100|two subjects were recruited in clinic. One withdrew after experiencing minor wrist discomfort, the other withdrew after determining the visit schedule undesirable.|
733242|NCT01582061||After a 21-day screening period, patients who met the inclusion/exclusion criteria received pasireotide subcutaneous twice a day (BID)
733243|NCT01582009||
733244|NCT01581970||
733245|NCT01581931||
733246|NCT01581710||
733247|NCT01581684||
733248|NCT01581658||
733249|NCT01581619||
733250|NCT01581541||
733251|NCT01581437||
733252|NCT01581307|Participants were enrolled at Moffitt Cancer Center June 2012 through March 2014.|
733253|NCT01581281|From July 16, 2012 through November 24, 2014, 488 patients were assessed for eligibility from 31 sites in the United States. Of those, 361 patients underwent randomization.|Of the patients assessed for eligibility, 21 (4%) did not undergo randomization owing to early trial closure and 106 (22%) were excluded. Eighty-one (81) were excluded due to not meeting inclusion criteria, 25 declined participation (13 were unwilling, but eligibility was otherwise confirmed and 12 were willing and eligibility was unknown).
733254|NCT01581021|Patients with adolescent idiopathic scoliosis were recruited at a University Mississippi Medical center clinic from Nov. 2005 to Dec. 2008.|After consent, the patient was given an identification number with the computer-generated randomized construct assignment. Enrolled participants might have been excluded from the study due to not being randomized.
733255|NCT01581008||One participant was a screen failure, thus 30 patients completed baseline surveys and were randomized.
733256|NCT01580995||
733257|NCT01580969||
733258|NCT01580904|From September 2009 to December 2011.Medical clinic|The exclusion criteria were (i) to have an infectious disease during the study, (ii) to miss three consecutive appointments, (iii) to stop the use of the hypoglycemic drugs by order of the doctor, and (iv) to deny the acceptance of the term of free and informed consent (TFIC).
733259|NCT01580670||
733260|NCT01580618|All patients were hospitalized patients with symptomatic loculated effusions. Each patient had a chest tube placed and loculated nature of the effusion confirmed by chest xray or CT after initial drainage of fluid from the chest tube.|Once loculation was documented, each patient was randomized to receive either normal saline or TNKase administered through the chest tube on a twice a day regimen for 3 days. For those in the TNKase group, each patient received 4mg TNKase in 60 mL normal saline twice daily. The normal saline group, each patient received 60mL normal saline.
733261|NCT01580592||
733262|NCT01580488|First subject first visit, start date: 24-Apr-2012 Last subject last visit, completion date: 05-Jun-2012|Prior to randomisation, the subjects entered a washout phase of up to 21 days (if required) where antipsoriatic treatment and other relevant medications or treatments had to be discontinued as defined by the exclusion criteria
733263|NCT01580423|Dates of recruitment: April to October 2012; Location: medical clinic|17 subjects recruited; 1 patient who signed the consent form did not meet inclusion/exclusion criteria, and no testing was performed.
733264|NCT01580410||
733265|NCT01580306||
733448|NCT01568008||This was an observational study of participants who received Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) at a dose and frequency as determined by the physician prior to entry into the study.
733266|NCT01580293|The study was conducted in 3 parts: Part A (main study [36-week treatment period] and an optional extension [at least 100 total exposure days]) and Part B for major surgeries (up to 3 weeks).|Of 149 participants screened in Part A, 134 were treated, reasons for non-inclusion were screen failure, consent withdrawal, and non-adherence to protocol visit windows. Participants selected either on-demand or prophylaxis treatment at start of study according to their preference. Randomization to prophylaxis arms occurred after week 10.
733267|NCT01580098||
733268|NCT01580072||Due to organisational changes in the participating home nursing organisation and due to the age of the patients no nurse monitoring patients were admitted. Furthermore a first examination in the hospitals seemed to be hindering for these patients.
733269|NCT01580020|A total of 140 patients with (BRVO) completed the core study CRFB002EDE17, and 127 patients with (CRVO) completed the core study CRFB002EDE18. 92 patients with BRVO and 83 patients with CRVO were enrolled into the extension study. A total of 175 patients (113 in the ranibizumab group and 62 in the dexamethasone group) were enrolled|The Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. LOCF=last observation carried forward
733270|NCT01579916|303 participants participated in the study from 21May2012 (date of first written informed consent) through 30Nov2012 (date of last participant visit).|Eligible participants were randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization was stratified by site.
733271|NCT01579812||
733272|NCT01579747|Patients recruited in UNMH and outpatient's surgical center|1 excluded because not meeting inclusion criteria. Patient lost weight prior to surgery
733273|NCT01579669|We recruited autistic adults via fliers, postings, and announcements targeted to autism and disability-related list-serves, organizations, and forums. We invited the autistic adult's primary care providers (PCPs) to participate if the patient gave permission for us to contact their provider and provided usable contact information.|"The total number of participants enrolled includes everyone who consented to participate. Some participants clicked yes to the online consent, but did not participate in the initial survey. The number of participants noted as Started in the Participant Flow module includes only those that took the initial survey."
733274|NCT01579578|Due to the early stopping of this study as a result of the AZD8931 program being stopped, the full planned enrolment was not carried out. This study was stopped after 39 were enrolled, 25 of whom were treated, which is less than the number planned in the protocol.|Due to the early stopping of this study as a result of the AZD8931 program being stopped, the full planned enrolment was not carried out. This study was stopped after 39 were enrolled, 25 of whom were treated, which is less than the number planned in the protocol.
733275|NCT01579565||
733276|NCT01579513||
733277|NCT01579474||
733278|NCT01579318|Participants were enrolled at 2 investigative sites in the United States from 08 June 2012 to 03 June 2014.|
733279|NCT01579305||"Enrollment was defined as having signed the IRB-approved Informed Consent Form. Prior to randomization, 4 subjects were excluded as screen fails, leaving an Intent-to-Treat population of 281 subjects."
733280|NCT01579214||
733281|NCT01579084||
733282|NCT01579045|Subjects were recruited and screened based on the inclusion/exclusion criteria.|
733283|NCT01579006||
733284|NCT01578993||
733285|NCT01578980||
733286|NCT01578967||
733287|NCT01578902|Patients were prospectively recruited from the Odette Cancer Centre from Oct 2006 to July 2008.|
733288|NCT01578850|The study consisted of Period 1 (an open-label, 24-week treat-to-target period), and Period 2 (a double-blind, randomized, 28-week period for participants who qualified for randomization).|The study was conducted in participants with rheumatoid arthritis (RA) who had moderate to severe disease activity despite methotrexate (MTX) therapy (≥10 mg/week) with or without other non-biologic disease modifying anti-rheumatic drugs (DMARDs) for at least 12 weeks prior to screening.
733289|NCT01578785||Two hundred seventy-four patients were screened and 178 randomized into the study in a 1:2 treatment arm ratio.
733290|NCT01578772||
733291|NCT01578707||
733292|NCT01578577||
733293|NCT01578551||
733294|NCT01578499|Participants took part in the study at 34 investigative sites in Australia, Belgium, Brazil, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States from 11 June 2012 to the Primary Completion data of 06 July 2018.|Participants with a diagnosis of cluster of differentiation antigen 30 (CD30)-Positive Cutaneous T-Cell Lymphoma were enrolled equally in 1 of 2 arms: brentuximab vedotin 1.8 mg/kg or physician's choice (Methotrexate or Bexarotene).
733295|NCT01578486||A total of 17 subjects consented and were screened, 4 of which were screen fails. The remaining 13 received the study medication.
733296|NCT01578330||
733297|NCT01578317||
733298|NCT01578278||
733299|NCT01578239|Overall Study Table includes all subjects who were enrolled prior to the primary endpoint data cutoff when 74 events of progression free survival were reached (24 July 2015).|
733300|NCT01578187|The study was conducted at a single site specialized in consumer product testing.|
733301|NCT01578044|Patients who are new starts on dabigatran, apixaban, and rivaroxaban and have completed the initial 3-month pharmacy follow-up will be approached by a pharmacist to inquire about their interest in participating in our study. Patients interested will verbally consent to participate and will then be randomized to the intervention or control group.|
733302|NCT01578031||The number of participants enrolled is the number of participants who agreed to participate in the study following completion of the informed consent process. The number of participants Started is the number of participants who were assigned to each Arm/Group.
733303|NCT01577966||
733304|NCT01577758|Participants took part in the study at 4 investigative sites in the United States and Spain from 11 June 2012 to 12 February 2014.|Participants with Gastrointestinal malignancies expressing guanylyl cyclase C were enrolled in the dose escalation phase: 0.3, 0.6, 1.2, 1.5, 1.8, 2.1 and 2.4 mg/kg to determine the maximum tolerated dose (MTD). MTD was established and participants were enrolled in the mCRC expansion phase. 3 participants were in both the 1.8 mg/kg and mCRC arms.
733305|NCT01577745|A total of 58 participants were screened at 7 sites in the United States of America (USA).|A total of 58 participants were screened for this study, of which 25 participants were enrolled and received study treatment.
733306|NCT01577732|321 subjects were screened and allocated a subject number for the study, out of which 300 participated in the study and received the study vaccination.|
733307|NCT01577706||
733308|NCT01577628||
733309|NCT01577537||
733310|NCT01577381||
733311|NCT01577329|Change was made to original number of participants due to human error. 51 persons were approached regarding possible enrollment.|
733312|NCT01577238||
733313|NCT01577186||
733314|NCT01577160||
733315|NCT01577108||
733316|NCT01576952||
733317|NCT01576939|The study took place at Stanford University. The study started in July 2011 and it ended July 2014.|No pre-assignment details as the patients were recruited and placed directly in the study.
733318|NCT01576874||
733319|NCT01576809|Study Start/End Dates 09 Mar 2012 to 27 Apr 2012|
733320|NCT01576783||
733321|NCT01576718||"1238 subjects with asthma at 180 centers were screened for enrollment. 889 subjects met entry criteria and were enrolled into the run-in period of the study. Of the 349 subjects who were not enrolled, 337 were excluded on the basis of inclusion/exclusion criteria, 5 subjects withdrew consent, and for 6 the reason given was other."
733322|NCT01576705|"Recruitment period : 2012-2016 First inclusion : 02/04/2012 Last inclusion : 14/12/2016
~Location : Institut Jérôme Lejeune"|As recruitment was nationwide and patients were included at a single centre, screening and randomisation were performed on the same day to minimise visits to the centre. Eligibility of randomised patients for TSH levels per exclusion criterion #8 was thus confirmed retrospectively, and patients with high TSH levels were discontinued.
733323|NCT01576588||
733324|NCT01576575||
733325|NCT01576549||
733326|NCT01576536|Healthy normotensive, non-smokers Caucasians and African-Americans aged 18-45 years were recruited via flyers and word of mouth from 2012-2015. No medications except oral contraceptives within two weeks and no antiplatelet medications within three weeks of the study. Women were studied in the first 14 days of their menstrual cycle.|
733327|NCT01576484|The study was conducted at 15 sites in the United States and Canada between 28 Feb 2012 and 22 Dec 2016. A total of 59 participants were screened in the study.|Out of 59, 58 participants received alirocumab in this open-label extension study.
733328|NCT01576471||
733329|NCT01576406||
733330|NCT01576367||
733331|NCT01576341|Patients, suffering from anemia associated with chronic Kidney Disease (CKD), were treated s.c. with HX575 at least once per week in order to achieve and maintain Hb concentration within the target range of 10.0 to 12.0 g/dL. 417 patients were enrolled.|Male and female patients (ESA [Erythropoiesis Stimulating Agent]-naïve/on ESA-maintenance therapy, i.v./s.c.) aged 18 years/older, suffering from anemia assoc. with CKD, with/without dialysis treatment. Anemia: Mean Hb conc. <= 11.0 g/dL for ESA naïve, 9.0-12.0 g/dL for patients receiving ESA therapy.
733332|NCT01576276||
733333|NCT01576172||
733334|NCT01576159||
733335|NCT01576146|This open-label extension study was conducted at 5 centers in the United States. Eligible participants must have completed 12 weeks of treatment in parent study 20120331 (KAI-4169-005; NCT01414114).|"This study consisted of 40 weeks of treatment in extension period 1 followed by 2 years of additional treatment in extension period 2.
~The Sponsor ended the study early. Participants had the opportunity to rollover into another open-label extension study 20130213 (NCT02102204)."
733336|NCT01576120||
733337|NCT01576055||
733338|NCT01576042||
733339|NCT01576016|"Lead safety phase: enrollment began on 03-30-2012 and ended on 06-18-2013; enrollment occured at 68 sites and 920 patients were enrolled.
~MRI Phase: study was approved by FDA on 03-26-2014. 255 patients were enrolled into the MRI Phase. 181 scans were completed by the 10-30-2014 cut-off date: 151 in the US, and 30 supplemental scans in Australia. The patients enrolled in the US came from the lead safety phase, the supplemental scans in Australia did not participate in lead safety phase."|The MRI phase was originally designed as a randomized study, with MRI and control groups, but due to challenges encountered with patient recruitment, it was later changed to a non-randomized study.
733340|NCT01576003|One participant consented and then withdrew prior completing any study procedure. This participant is not included in the participant flow due to the fact no study procedures or randomization occurred.|
733341|NCT01575912||
733342|NCT01575899|We included H. pylori-positive adult patients assessed by the rapid urease test and histology during the period December 2007 to December 2009 from the out-patient clinic of a single medical center located at Hualien, Eastern Taiwan.|We excluded patients under the age of 20, woman in pregnancy or breast feeding, those with concomitant illness or conditions (i.e., cardiopulmonary, hepatic, renal diseases, neoplastic diseases), those with severe complication of peptic ulcer disease, like obstruction or perforation, those with allergy to any of the drugs used.
733343|NCT01575873|"Participants were enrolled at 79 centers in Europe, North America, Latin America, and Korea from 28 March 2012 to 30 June 2015.
~Participants who had been taking glucocorticoids for at least 3 months were classed as glucocorticoid continuing; those who were taking glucocorticoids for less than 3 months were classed as glucocorticoid initiating."|Eligible patients were randomly assigned in a 1:1 ratio to receive 60 mg denosumab every 6 months or 5 mg oral risedronate daily for 24 months within each subpopulation. Randomization was stratified by sex within each subpopulation.
733344|NCT01575860||
733345|NCT01575834|"This study was conducted at 222 centers in Europe, Central/Latin America, Asia, North America, and Australia/New Zealand.
~The first participant enrolled on 15 March 2012 and the last participant enrolled on 06 December 2013."|Participants were randomized 1:1 to receive either romosozumab 210 mg or matched placebo for the 12-month, double-blind, placebo-controlled period. Randomization was stratified by age (< 75 years, ≥ 75 years) and prevalent vertebral fracture (yes, no), as determined by site staff at randomization based on local reading of the spine X-ray.
733889|NCT01539512|Participants were enrolled at a total of 53 study sites in the United States and Europe. The first participant was screened on 03 April 2012. The last study visit occurred on 20 April 2014.|
733346|NCT01575808||133 participants were enrolled into the GP1101 arm; 14 were training cases, 16 were excluded by the Case Conference Committee; total participants started was 103. Retrospective Surgical Bypass Outcomes represent historical controls (n=68).
733347|NCT01575769||Participants who completed Visit 33 (Week 104) of the core study WA19977 (NCT00988221) with at least juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 clinical response were eligible to continue the study therapy within this long-term extension study in Russia and Poland.
733348|NCT01575756||
733349|NCT01575561||
733350|NCT01575522||
733351|NCT01575275||
733352|NCT01575197||
733353|NCT01575106||
733354|NCT01575080||
733355|NCT01575054||
733356|NCT01575028||
733357|NCT01574807|Recruitment occurred from august 2011 to May 2013 in the dental clinic of the College of Dentistry.|No subjects were excluded from the study.
733358|NCT01574716|Participants took part in the study at 31 investigative sites in the United States, Australia, Italy, Netherlands, France and Belgium from 07 August 2012 to 02 August 2016.|In Part 1, a total of 16 participants were enrolled and treated in the study. A total of 225 participants were screened for entry into Part 2 of the study. Of these 225 participants, 46 were screen failures and 209 were randomized into the study, of which 207 participants were treated.
733359|NCT01574703|Of the 6293 participants who completed the parent study NCT01456936 as per protocol, a total of 4595 participants enrolled into this study NCT01574703 from 132 centers in 16 countries.|This is a non-treatment extension study of parent study NCT01456936. No study drug was provided in this extension phase. However, cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline(N=2016), bupropion(N=2006),NRT(N=2022), or placebo(N=2014) in a triple-dummy design were analyzed in this study.
733360|NCT01574651||
733361|NCT01574612||
733362|NCT01574352||Due to practical circumstances, it was not possible to conduct baseline measurements before randomization. Consequently, 9 participants dropped out before baseline measurements toke place.
733363|NCT01574326|The study was conducted at 29 centers in 4 countries. A total of 128 participants were screened between 11 May 2012 and 14 November 2014. Of whom, 101 participants were randomized and 27 were screen failures.|Participants were stratified in (1:1) by screening body surface area (BSA) (≥1.2 vs <1.2 m^2) & qualifying serum phosphorus (≥7.0 vs <7.0 mg/dL) to get sevelamer carbonate or placebo in 2 week fixed dose period (FDP). Following FDP, participants entered 26-week dose titration period (DTP) during which all participants received sevelamer carbonate.
733364|NCT01574287||
733365|NCT01574248||
733366|NCT01574183|Participants recruited between August, 2012 and August, 2014 primarily through media and internet advertisements.|
733367|NCT01574157|Participants were recruited from VA Salt Lake City Healthcare System from November 2012 to October 2017.|
733368|NCT01574144||
733369|NCT01574105|Began May 1, 2012 Completed January 15, 2013 Patients identified in preadmission clinic or ward.|Exclusion criteria included: renal failure, liver dysfunction, baseline INR >1.5, clotting factor deficiencies, intra-aortic balloon pump therapy, emergency surgery, pregnancy, ejection fraction less than 50%, age less than 18 years, pulmonary hypertension infectious endocarditis, and history of heparin induced thrombocytopenia.
733370|NCT01574079||
733371|NCT01573949||
733372|NCT01573910|Participants were recruited from 16 study centers located in China.|Of the 985 enrolled, 3 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (982).
733373|NCT01573767|1208 participants (par.) were screened; 760 entered the Run-in Phase, 463 were randomized, and 2 received study medication (SM) but weren't randomized/included in the Intent-to-Treat (ITT) Population (randomized to treatment and receiving >=1 SM dose). 7 randomized par. didn't receive SM; hence, 456 par. comprised the ITT Population.|Participants who met the eligibility criteria at screening (Visit 1) entered the Run-in Phase for completion of Baseline safety evaluations and measures of asthma status. Participants meeting all randomization criteria at Visit 3 were randomized to 1 of 4 treatment arms. The total duration of study participation was up to a maximum of 9 weeks.
733374|NCT01573624|The study was conducted across 33 centres of 5 countries from 03 April 2012 to 04 February 2013 in adults aged 18 to 50 years with persistent asthma. Participants were randomized for 3 treatment periods of 2 weeks each.|A total of 706 participants were screened for this study designed in 3 period crossover, incomplete block manner; 523 participants entered 2-week open label run-in period where they received fluticasone furoate (FF) 100 micrograms (mcg) dry powder inhalation once daily. A total of 421 participants were randomized to double-blind treatment period.
733375|NCT01573572||
733376|NCT01573533||
733377|NCT01573442||
733378|NCT01573325|50 Subjects were recruited from NMH clinic and satellite clinics. Recruitement was from 03/29/12 to 06/19/12|
733379|NCT01573273||112 is the total number of participants randomized. 112 completed the TSST, which was between groups. MRIs were within subjects; 99 completed at least MRI 1. 96 completed MRI's 1 and 2. Data is reported per testing condition.
733380|NCT01573260||
733381|NCT01573052|Subjects recruited from VA outpatient detoxification clinic|Exclusions: subjects requiring hospitalization, receiving benzodiazepines prior to randomization and subjects not likely to follow instructions.
733382|NCT01573000||Participants (par.) received radioimmunotherapy of tositumomab (TST)/Iodine I 131 TST (Arm A) or unlabeled TST (Arm B) in 2 phases: dosimetric and therapeutic dose. Arm B par. were allowed to crossover and receive I 131 TST, if disease progressed. After TST treatment, par. could have entered a Long-Term Follow-Up study (BEX104526; NCT00240591).
733383|NCT01572948|Subjects were recruited from a single center.|
733384|NCT01572922|Patients within the St. Jude Network (St. Jude Children's Research Hospital, St. Jude Domestic Affiliates, and the adult Hematology and Oncology program at the University of Tennessee Health Sciences Center) who have history of 12 or more lifetime erythrocyte transfusions, and need for liver iron content assessment.|One arm study
733385|NCT01572909||
733386|NCT01572844||All participants enrolled required 2 similar calcinosis lesions; one for the treatment arm and one for the no treatment arm.
757973|NCT00182754||
733387|NCT01572792|This study was conducted at 169 study centers, 160 in the United States, and 9 in Canada. The first patient was screened in April 2012 and the last patient visit was in June 2013|"This was a double-blind, placebo- and active-controlled, 28-week treatment, extension study of the lead-in study, Study LAC-MD-31
~Those patients who chose to continue the treatment in the extension study and met the eligibility for the extension study remained on the same treatment as they were randomized to in the lead-in study"
733388|NCT01572740|This trial was conducted at 23 sites in Japan.|Subjects on pre-trial insulin (basal insulin [intermediate acting human insulin, intermediate acting insulin analogue or long-acting insulin analogue], premixed insulin or basal-bolus regimen) therapy for at least 12 weeks prior to screening.
733389|NCT01572727|416 patients randomized patients, 405 received the study treatment & 403 had at least 1 post-baseline safety assessment. Randomization of patients was stopped following DMC decision & all but 5 still benefiting from the treatment were discontinued. The DMC decision was based on pre-defined futility criteria at time of the adaptive interim analysis.|A total of approximately 524 patients were to be randomized in a 1:1 ratio to one of the two treatment arms irrespective of the adaptation decision to continue in the full or PI3K pathway activated subpopulation. Randomization was stratified by PI3K activation and Hormone Receptor status.
733390|NCT01572675||621 total participants were screened; 71 participants were excluded for inclusion criteria violation and 3 were excluded for unavailability of informed consent.
733391|NCT01572428||Number of patients enrolled(898) differs from number of patients started(804). This is because 94 patients were enrolled but not randomized for various reasons such as inadequate bowel preparation, research personnel/scope not being available, ineligibility of patient per colonoscopist discretion, patient withdrawing consent prior to randomization.
733392|NCT01572389||There were a total of 225 participants enrolled into the study. Consent occurred at baseline and participants were eligible if they scored a 10 or greater on the PHQ-9 and an A1C of 7.5 or greater. If a participant didn't meet these criteria then they were not randomized into the study.
733393|NCT01572298||
733394|NCT01572207||
733395|NCT01572038||A total of 1697 patients were screened: 261 failed screening and 1436 were enrolled in the study.
733396|NCT01571557||
733397|NCT01571453|In- or outpatients with a primary diagnosis of recurrent of Major Depressive Disorder (MDD) were recruited for this study from China, South Korea, Taiwan, and Thailand.|A Screening Visit was held approximately 7 days prior to group assignment (group assignment was held during the Baseline Visit). Patients who met each of the inclusion criteria at the Screening and Baseline Visits and none of the exclusion criteria at the Screening and/or Baseline Visit were eligible to participate in this study.
733398|NCT01571427|From November 2011 to August 2012, we distributed 2000 surveys targeting those living in retirement communities and senior centers located in the Portland, metropolitan area, within an approximately 1-hour commute from Oregon Health & Science University (Portland, OR).|
733399|NCT01571362|A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Determine the Efficacy and Safety of ALO-02 Extended-Release Capsules in participants with Moderate to Severe Chronic Low Back Pain|A total of 410 participants were enrolled into the Open-Label Conversion and Titration Period and 281 participants were randomized into the Double-Blind Treatment Period, of which, 280 participants received study treatment.
733400|NCT01571284|The study was conducted at 151 sites in 23 countries. A total of 798 participants were screened between 30 May 2012 and 03 January 2015, out of which 781 participants were enrolled and 779 participants were treated.|Participants enrolled in the study to assess the safety of Aflibercept in participants treated with a combination of Aflibercept with FOLFIRI regimen (Irinotecan, Leucovorin and 5-Fluorouracil [5-FU]).
733401|NCT01571232||
733402|NCT01570868|Recruitment period: April 27, 2012 to May 12, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|Study terminated early.
733403|NCT01570751|The trial was conducted at 37 sites in the United States of America (USA).|All subjects were on insulin glargine (IGlar, ≥ 65 U and ≤ 100 U/mL in 10 mL vials) treatment once daily (OD) administered subcutaneously at any time of day preferred by the subject for 16 week run-in period along with the daily pre-trial metformin dose.
733404|NCT01570686||A total of 691 patients enrolled in the study with 590 patients randomized. 1 patient was mis-randomized and did not receive study medication, therefore 589 patients actually received study medication.
733405|NCT01570634|Recruiting was managed by Scott & White|
733406|NCT01570491|patients were recruited and enrolled from 4/2012 to 10/2012 at Cleveland clinic, main campus.|
733407|NCT01570387|Protocol was open to accrual between January 2012 and August 2016. Participants were recruited from within the amyloidosis clinic within Boston Medical Center.|
733408|NCT01570361|The first subject was enrolled on 13-Feb-2012. On 27-Feb-2018, study was terminated early due to enrollment not proceeding in accordance with expectations, independently from the study outcome. The last subject completed the last visit on 29-May-2018.|Before randomization and signing inform consent forms, all subjects were screened according protocol defined inclusion and exclusion criteria. Screening failures were excluded from the study and were not randomized.
733409|NCT01570348|Participants were recruited 7/2012 and 8/2015 via website (www.CATS-FHCRC.org). Over 700 completed questionnaires, >150 were deemed potentially eligible. 15 completed records reviewed and invited for in-depth screening for eligibility. Two study participants were enrolled.|
733410|NCT01570309|Recruitment from October 2008 through December 2010 from the cardiac catheterization laboratories and outpatient clinics of the Jacobi Medical Center and Montefiore Medical Center in the Northeastern section of the Bronx, NY. Additional recruitment occurred at Crystal Run Health in Orange County, NY.|Subjects with ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization, were screened for vitamin D deficiency by measurement of serum 25-hydroxyvitamin D (25-vitamin D).Eligible subjects with a 25-vitamin D level < 20 ng/ml were randomly assigned 1:1 to active or placebo treatment
733411|NCT01570283||
733412|NCT01570244||
733413|NCT01570192|We had 8 clinical sites: recruitment into the study began September 2010 and ended April 10, 2015.|Enrolled participants were excluded from the trial before assignment to groups because participants had no qualifying organisms; this includes participants with no growth on screening BAL, those with < 104 CFU/mL on BAL, and those with only Gram-positive bacteria cultured from the BAL.
733414|NCT01570036||
733415|NCT01569841|The trial was conducted at one site in the United States of America (USA).|All subjects were on basal-bolus insulin regimens at screening using insulin glargine (IGlar) and either insulin aspart (IAsp) or insulin lispro (ILis). During the run-in period, IGlar 100 U/mL was administered subcutaneously (under the skin) once daily (OD) in the morning (before breakfast) along with IAsp 100 U/mL as meal-time insulin.
733416|NCT01569828||
733417|NCT01569815||
733418|NCT01569763|Subjects were enrolled in the clinical trial at 13 Investigational Sites in the U.S., Canada, and Mexico between March 2012 until November 2013.|A total of 153 subjects were enrolled and randomized 2:1 to the Minerva (Aurora) Test Group (n=102) or the Rollerball Control Group (n=51). As part of the randomization process, subjects were stratified by age, though there was no attempt to enroll an equal number into the < 40 and > 40 age groups. All 153 subjects were successfully treated.
733419|NCT01569737|"Ella-exposed pregnant women were recruited either by Health Care Professionals at Family Planning Clinics or through web-based self enrollment between November 2014 and December 2017.
~The first participant was enrolled on November 18, 2014 and the last participant was enrolled December 12, 2017."|
733420|NCT01569607|Participants were recruited between March 2012 and August 2016.|Participants completed the eligibility phase prior to being randomized to a study arm. Of the 48 participants that provided consent, 22 were eligible for participation and were randomized to an intervention.
733421|NCT01569594||
733422|NCT01569568||
733423|NCT01569529|"All recruitment took place online. A No ad exposure group was generated from program registrants, during a 4-week period (05/07/2012 - 06/03/2012) prior to the intervention.
~Recruitment for the Ad exposure intervention group took place during three 4-week periods: 06/04/2012 - 07/01/2012, 07/30/2012 - 08/26/2012, 09/24/2012 - 10/21/2012."|
733424|NCT01569464|The recruitment for the RL0003 study began in March 2012. It concluded in April 2013. Recruitment for this study took place in the United States of America.|"The participant flow consists of the Randomized Set (RS), which is all subjects randomized into the study.
~The demographics and study outcomes consist of the Full Analysis Set (FAS), which includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."
733425|NCT01569451||
733426|NCT01569438|Overall, 107 participants were randomized (55 in Gefapixant intervention group, and 52 in Placebo group).|Of 107 participants randomized to the study, 105 received at least one dose of study treatment (All Treated Population) and were evaluable for all safety analysis.
733427|NCT01569295|Participants were enrolled at a total of 110 sites in Australia, New Zealand, Europe, Asia and North America. The first participant was screened on 15 June 2012. The last study visit occurred on 10 June 2019.|540 participants were screened.
733428|NCT01569191||
733429|NCT01569152|This trial was conducted at 58 trial centers in the United States, Canada, Chile, Denmark, South Africa, Germany, Hungary, Japan, Lithuania, Moldova, Poland, South Korea, Taiwan, and in the United Kingdom. A total of 213 participants were screened and 82 were enrolled.|The internal data monitoring committee made the decision to discontinue the study before initiation of Base Study Phase IIb. Thus, participants were enrolled in Base Study Phase IIa and the Study Extension (Period 3) only.
733430|NCT01569126||The study consisted of 2 parts: the open-label, single-dose (SD) period which included 3 cohorts (Cohorts 1 to 3) and the placebo-controlled, multiple-dose (MD) period which included 2 cohorts (Cohorts 4 and 5).
733431|NCT01569087||
733432|NCT01569074|A total of 298 patients were enrolled: 31, 33, 33, 33 & 33 were randomised to Groups A, B, C, D & E respectively (all received at least 1 dose of investigational product).|A total of 135 patients failed screening.
733433|NCT01569022|A total of 127 Veterans were considered for study participation between August 2013 and April 2016. Fifty-four patients agreed to enroll in the study but twelve patients either failed to return for scheduled visits or withdrew from further participation because of lack of time or other pressing matters. Forty-two were randomized to CPAP or MAD.|
733434|NCT01568944||
733435|NCT01568905||
733436|NCT01568892||Participants (par.) meeting eligibility criteria at screening entered a 7-day randomized, double-blind, placebo-controlled phase. At Day 8, all par. entered an open-label phase and continued to receive dolutegravir with an optimized background regimen. A total of 75 par. were screened; 45 par. were screen failures, and 30 par. were randomized.
733437|NCT01568866|"Adults with relapsed multiple myeloma were enrolled between 20 June 2012 and 30 June 2014 at 198 centers in 27 countries in Europe, North America, South America, and the Asia-Pacific region.
~Results are reported as of the data cut-off date of 03 January 2017, the pre-specified 2nd interim analysis of the secondary endpoint of overall survival."|Randomization was stratified by previous proteasome inhibitor therapy (yes vs no), previous lines of treatment (1 vs 2 or 3), International Staging System stage (I vs II-III), and planned route of bortezomib administration (intravenous vs subcutaneous) if randomly assigned to the bortezomib group.
733438|NCT01568827||
733439|NCT01568606||
733440|NCT01568593||
733441|NCT01568528|Participants were recruited fom the Atlanta VA Medical Center in Atlanta, GA. Enrollment began in March 2013 and all study activities ended in March 15th, 2017. A total of 39 individuals were consented to participate in the study and passed screening, were randomly assigned to treatment arm and are included in the following results.|"Two groups of participants were enrolled in the trial: Healthy controls and Schizophrenia subjects. The schizophrenia subjects were then randomized to either Oxytocin or Placebo.
~Note: for eye tracking and game outcomes, some subjects did not yield analyzable results due to the technical issues. Their data were therefore missing."
733442|NCT01568424|This study included data from 25 consecutive patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life. All patients implanted with a CentriMag RVAS were approached for enrollment.|
733443|NCT01568112||
733444|NCT01568073||
733445|NCT01568047||
733446|NCT01568034||
733447|NCT01568021||This was a Post-Marketing Surveillance Study of OZURDEX®. 100 participants who received OZURDEX® as standard of care in clinical practice were enrolled in the study. Only 99 participants who had data recorded at Baseline and Follow-up were included in the analyses.
733890|NCT01539317|January 2012 to June 2013; Women's Health Research Unit (WHRU) at Oregon Health and Science University (OHSU) in Portland, OR|
733449|NCT01567943||123 participants were enrolled, but only 79 met criteria to be randomized. Criteria for randomization included: EtG-positive urine sample during 4-week pre-randomization phase of the study, and adequate attendance during the pre-randomization phase.
733450|NCT01567891||
733451|NCT01567865||
733452|NCT01567852||
733453|NCT01567839|Recruitment at the College of Dentistry between May 2012 and December 2012.|No exclusions. All subjects enrolled were utilized and assigned.
733454|NCT01567826|779 patients consecutive patients with chronic stable angina presenting for elective coronary angiography were screened from May 21, 2010 until Jan 10, 2012. 87 participants met criteria and were randomized.|
733455|NCT01567527|This trial was conducted in 1175 subjects (including 444 screen failures) at 103 trial sites in the following 7 countries: Canada, Japan, Republic of Korea, Poland, Romania, Taiwan, and the United States (US).|The trial consisted of a screening phase and 4 phases. In Conversion, Oral Stabilization and IM Depot Stabilization Phases, there was a single treatment group. In Double-blind, Placebo-controlled Phase, there were 2 treatment groups. All Outcome Measures were assessed in the Double-blind, Placebo-controlled Phase of the study.
733456|NCT01567462|Participants were recruited between September 2012 and March 2017. Of the 95 participants who signed consent, 90 subjects began study participation.|
733457|NCT01567371||
733458|NCT01567306||
733459|NCT01567163||
733460|NCT01567150||4 subjects attended only one study visit thus did not have evaluable data
733461|NCT01567085||
733462|NCT01567020||
733463|NCT01566981||
733464|NCT01566838||
733465|NCT01566773|The study was conducted at 10 sites in the US from April 2012 to August 2012. Study participation maximum of 26 weeks.|A randomized, double-blind,chronic dosing, four-period, eight-treatment, placebo-controlled, incomplete block, crossover, multicenter study.
733466|NCT01566721||Of the 2984 participants screened, a total of 2577 participants were enrolled into the trial, and 2573 participants received at least one dose of study treatment.
733467|NCT01566695|Participants were randomized at 101 sites globally. The sites were located in: Europe (76), North America (13), Asia/Pacific (10), and Latin America (2). Results are reported as of the data cut-off date of 25 January 2019.|Participants were stratified by: average baseline (BL) Red Blood Cell (RBC) transfusion requirement (≤ 4 units versus > 4 units of RBC per 28 days), BL platelet transfusion status (dependent or independent), country of enrollment and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 to 1 versus 2).
733468|NCT01566682||
733469|NCT01566630||
733470|NCT01566604|Participants were randomized in a 2: 1 ration to NVA237 and Placebo, respectively.|
733471|NCT01566539|A total of 707 signed the consent form, 449 started the main study period.|"The study team did not recruit any participants for the Anxious and Depressed Subjects - OT, or Anxious and Depressed Subjects - Placebo arms.Therefore, these arms have been removed from the record."
733472|NCT01566526||
733473|NCT01566500||
733474|NCT01566461||The IN.PACT SFA Trial was designed as a two-phase randomized trial. IN.PACT SFA I, the first phase, was conducted in Europe with 150 subjects enrolled. IN.PACT SFA II, the second phase, was conducted in the US with 181 subjects enrolled. The randomized data from both phases are pooled and comprise the pivotal trial data.
733475|NCT01566435|The study opened to participant enrollment on 08/09/2012 and closed to participant enrollment on 11/07/2013.|
733476|NCT01566409||
733477|NCT01566370||
733478|NCT01566331||
733479|NCT01566214||
733480|NCT01566162||
733481|NCT01566149|Participants were recruited from one study site in Vietnam between March 2012 and September 2012.|Participants who were previously on medium-dose asthma medication were assigned to Mometasone Furoate/Formoterol Fumarate (MF/F) 200/10 mcg Metered Dose Inhaler (MDI) twice daily (BID) and participants who were previously on high-dose asthma medication were assigned to MF/F 400/10 mcg MDI BID.
733482|NCT01566084||
733483|NCT01565993|From 2007 to 2010, the patients were selected at the digestive endoscopy unit.All of the consecutive patients referred for colonoscopy to the endoscopy office were informed of the aims of the ongoing research and were invited to take part in the study for which they gave their informed consent before the endoscopic procedure was performed|Where more than one polyp was observed in a patient, all the polyps were included in the same randomization group, so that they all underwent the same technique (conventional or modified polypectomy). 3 patients were excluded for failing to meet the inclusion criteria since they involved semi-pedunculated polyps measuring less than 1cm.
733484|NCT01565980|Patients were recruited from two community-based hospital sites and one cancer center located in Chicago Illinois. Recruitment occurred between March 2012 to February 2013.|There were no participants excluded from the trial before group assignment. However, there were patients who dropped from the study before starting the intervention.
733485|NCT01565941||
733486|NCT01565928||
733487|NCT01565902|Up to forty-eight subjects were planned to be enrolled in four groups. A total of 40 subjects were enrolled and completed the study. All subjects were included in the safety and PK analysis. However, only 38 subjects were included for primary PK analysis based on matched pair analysis|To potentially reduce the number of healthy subjects exposed to BAF312, study allowed for multiple matching of subjects with hepatic impairment to healthy subjects. During the study, 2 healthy subjects were not matched to any of the subjects with hepatic impairment due to a retrospective identification of a better matching partner
733488|NCT01565889|52 participants were enrolled at one study site in Puerto Rico, a commonwealth of the United States (US). The first participant was screened on 27 February 2012. The last participant observation occurred on 10 December 2013.|"Part A: 52 participants were screened; 38 were enrolled and treated, and comprise the Part A Safety Analysis Set (SAS) and Part A Full Analysis Set (FAS).
~Part B: 42 participants were screened; 23 were enrolled and treated (9 from Part A and 14 who joined the study), and comprise the Part B SAS and Part B FAS."
733489|NCT01565850|Participants were enrolled at study sites in the United States (including Puerto Rico). The first participant was screened on 16 April 2012. The last study visit occurred on 19 February 2014.|232 participants were screened.
758021|NCT00178256||
733490|NCT01565707|The study population consisted of male and female children (5 to 11 years old) and adolescents (12 to 17 years old) with overactive bladder (OAB).|Subjects received 4 weeks of urotherapy (standard first line therapy for pediatric OAB patients). Two weeks after start of urotherapy a single-blind 2-week placebo run-in period began. After run-in period eligible subjects were randomized to 12 weeks of double-blind treatment (solifenacin succinate suspension or placebo) and continued urotherapy.
733491|NCT01565694|The study population consisted of male and female participants with neurogenic detrusor overactivity (NDO) aged 5 years to < 18 years old.|After screening and a 14-day washout period, participants were treated with sequential doses of solifenacin oral suspension for 12 weeks (titration period) to determine each participant's optimal dose, after which a fixed dose of solifenacin oral suspension was given for at least 40 weeks (fixed dose assessment period).
733492|NCT01565668|A total of 76 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study (intent-to-treat population). Participants were enrolled at 22 clinic sites in North America and Europe (14 sites in the United States, 6 in France, 1 in Italy, and 1 in the United Kingdom).|Participants were randomized (1:1) to receive 30 or 60 mg/day quizartinib. These doses were selected based on evidence of efficacy and safety observed in studies AC220-001 and AC220-002, and preclinical data.Two participants who were randomized to quizartinib (60 mg/day) did not receive study drug and are not included in the safety data.
733493|NCT01565642|April 2012 to September 2014 enrolled dyads of persons with advanced dementia and family decision-makers from 22 participating nursing home sites.|
733494|NCT01565616|Participants were enrolled from 8 study locations between March, 2012 and June, 2015.|The first component of the study was restricted to 5 patients with a related donor. If no more than 2 of the first 5 patients experienced unacceptable toxicity within six months of transplantation then the safety of the regimen was considered promising and the study could include patients with a related or unrelated HLA matched donor.
733495|NCT01565564||
733496|NCT01565551||
733497|NCT01565538||
733498|NCT01565499||There are two patients that have not received any cycle and they are excluded of analysis by ITT criterium: One patient did not receive any cycle, ended treatment by investigator´s criterium and the other patient withdrawn informed consent before starting the treatment.
733499|NCT01565382|NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained from 25 mild cognitive impairment (MCI) subjects and 15 Alzheimer's Disease (AD) subjects randomly selected from Study A05 (NCT00702143).|
733500|NCT01565369|NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies|
733501|NCT01565356|NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies|
733502|NCT01565343||
733503|NCT01565330||
733504|NCT01565291||
733505|NCT01565148||
733506|NCT01565083||Due to non-randomized nature of the study (single infusion cohort started enrollment only after separate infusion cohort recruitment was completed) and different baseline characteristics of participants, the comparison between the 2 cohorts was not performed. Hence, the efficacy and safety results for the 2 cohorts should be considered separately.
733507|NCT01564953|Recruitment took place in an outpatient clinic for respiratory diseases in Aarhus University Hospital, Denmark, during summertime in order to minimize seasonal variations of serum vitamin D.|Missed inclusion was due to either unstable disease (54 patients) or unwillingness to participate (87 patients).
733508|NCT01564914|Patients were screened and enrolled at 4 sites|
733509|NCT01564862|Participants took part in the study at 80 investigative sites in Bulgaria, Finland, Germany, Poland, Russia Federation, Ukraine.and the United States from 09 April 2012 to 05 February 2014|Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 3 treatment groups, once a day placebo, 10 to 20 mg flexible dose of vortioxetine, or 60 mg duloxetine.
733510|NCT01564784||164 participants were randomized to Inotuzumab Ozogamicin and 162 to Defined Investigator's Choice of Chemotherapy. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the intention-to-treat (ITT) population.
733511|NCT01564758||
733512|NCT01564732|17 subjects consented to participate: 1 from Duke University and 16 from the University of Pittsburgh, 6 had not completed surgery before the study termination (2 withdrawn by the PIs and 4 were still in their pre-surgical workup). 11 participants had surgery and were randomized (per the protocol) to plicated band (PLAGB) or standard band (SLAGB).|
733513|NCT01564706||
733514|NCT01564693||
733515|NCT01564628||
733516|NCT01564537|Participants enrolled in this study at 147 sites in Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Sweden, Turkey, United Kingdom and US from 28 Aug 2012 to 27 May 2014.|Participants with a diagnosis of relapsed and/or refractory multiple myeloma were enrolled in 1 of 2 treatment groups: Ixazomib 4 mg or Ixazomib placebo-matching tablets in combination with lenalidomide, and dexamethasone. Data cut-off for this first analysis was 30 October 2014. The study is continuing in a double-blind fashion.
733517|NCT01564459||
733518|NCT01564407|Multiple approaches for subject recruitment were implemented.The Center for Innovation in Restorative (CIRM) hired a marketing specialist who investigated the use of non-traditional mechanisms within and outside the existing infrastructure including but not limited to social media outlet,use of internal/external physician networks,TV advertising|All of the subjects who were enrolled (signed consent) were randomized to 1 of 4 cohorts.
733519|NCT01564394|We recruited 502 senior prostate cancer survivors in Utah through clinic referrals, registries, community advertisements, and community-based support groups.|Out of 89 prostate cancer survivors screened for eligibility, forty were eligible and interested in participating in the study.Twenty family members met criteria for participating. Only the survivors were randomized to study arms. Family members attended the study arm that the survivor was randomized to.
733520|NCT01564277||
733521|NCT01563978|A total of 266 patients were enrolled.|A total of 131 patients failed screening.
733926|NCT01536704|Participants were recruited at the clinical site.|Out of 141 participants screened, only 50 were randomized since 91 were screen failures.
733522|NCT01563913|Subjects were recruited from two large urban hospitals with Movement disorder specialty clinics in the NW USA over a 30 month (2.5 year) recruitment period. 34 subjects were screened. 1 subject screen failed due to prior exposure to levodopa. 33 subjects were randomized to DHA or placebo arms. 30 subjects returned and completed visit 1.|
733523|NCT01563536||
733524|NCT01563406|140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.|Two separate wings of a 24-bed MICU were randomized to receive different intervention sequences. Wing A was assigned to a 15 sec scrub of 1) Alcohol; 2) chlorhexidine gluconate (CHG)+Alcohol; 3) Alcohol; and Wing B was assigned to a 5 sec scrub of 1) CHG+Alcohol; 2) Alcohol; 3) CHG+Alcohol.
733525|NCT01563198||Different participants were assessed at baseline and after training.
733526|NCT01563185||
733527|NCT01563172|Participants were recruited from 1 center in the USA.|Total of 74 participants were screened for the study, out of which 65 participants were randomized in the study. Nine participants were screen failures.
733528|NCT01563081||
733529|NCT01563055||This study consisted of two parts. In part A of the study, the eligible participants (par.) were enrolled to assess the tolerability of ofatumumab with chlorambucil. After confirmation of the tolerability, Part B of the study was initiated. The total number of participants in Part A and Part B was 10.
733530|NCT01563029|1540 participants were screened, 596 participants were randomized, and 593 participants comprise the Intent to Treat Population which include all participants who received at least one dose of study treatment. Participants were stratified at randomization according to their prior inhaled corticosteroid (ICS) use.|Participants who met the eligibility criteria at screening (Visit 1) entered a 4-week Run-in Period during which they continued their existing medications. Participants who met the randomization criteria (remained uncontrolled despite baseline therapy) at Visit 3 were randomized to 1 of 5 treatment arms for 12 weeks followed by a 1-week follow-up.
733531|NCT01563003||
733532|NCT01562886||
733533|NCT01562873|Patients enrolled from October 2012 through June 2014.|Patients must have had sufficient archival specimen for central pStat3 testing to be eligible.
733534|NCT01562782|Between 4/2012 and 10/2013 fifteen South Asians and 15 Caucasians were studied as outpatients at the Weill Cornell Medical College Clinical and Translational Science Center (CTSC).|At the CTSC clinic, consented volunteers had their medical history reviewed and a physical exam performed. A fasting blood sample was obtained to screen for lipid and biochemical abnormalities, thyroid and liver disease, anemia, pregnancy and diabetes/glucose intolerance.
733535|NCT01562756||
733536|NCT01562743||
733537|NCT01562678||
733538|NCT01562613||
733539|NCT01562548|Participants were recruited at multiple clinical sites|Male or female participants aged 18-65 years (inclusive) with acute onset upper back/neck/shoulder muscle spasm and pain were recruited in this study
733540|NCT01562444|Subjects who completed V48P7E1 study having received primary vaccination according to rapid (R), conventional (C) or accelerated conventional (AC) schedule were included in the study. Since modified conventional (MC) had not been accepted by health authorities as primary vaccination schedule, this group from V48P7 was not enrolled in this study.|206 subjects were enrolled in the study but one subject was not assigned to any group. Therefore, the number of subjects started is 205.
733541|NCT01562379||
733542|NCT01562327||
733543|NCT01562314||
733544|NCT01562275||Study included two stages. Stage 1: dose escalation cohorts (DEC), consisted of Arm A (concurrent 21 day dosing followed by 7 day dosing holiday) and Arm B (intermittent dosing). Stage 2: indication specific expansion cohorts (PTEN-low endometrial carcinoma and PTEN-low triple-negative breast cancer) treated with recommended phase 2 dose.
733545|NCT01562132||
733546|NCT01562028|Between June 11, 2012 and Oct 28, 2014, 109 eligible patients were enrolled in 29 centers of eight European countries (Spain, Switzerland, UK, Greece, Italy, Ireland, France and Germany). All patients were included in the efficacy analysis.|
733547|NCT01561989|unable to meet accrual objective. study closed.|unable to meet accrual objective. study closed.
733548|NCT01561976|This study was conducted at one center in India from 30 January 2012 to 21 February 2012.|A total of 30 participants were enrolled in this study. METLEAD™ Forte SR (metformin hydrochloride prolonged release) and METLEAD™ G2 Forte (metformin hydrochloride sustained release/glimepiride) are registered product of GlaxoSmithKline.
733549|NCT01561898|This study comprises patients who have participated in previous study JNS007ER-JPN-S31 (NCT00396565) and new patients. New patients were classified as group NO/PAL. Patients entering from study JNS007ER-JPN-S31 were classified according to their origin groups: placebo group (PLA/PAL), paliperidone group (PAL/PAL), and olanzapine group (OLZ/PAL).|
733550|NCT01561833||
733551|NCT01561755|Participants were recruited from three main sources: the clinical NeuroAIDS practices of the investigators; pre-existing observational research studies (Manhattan HIV Brain Bank and the CNS HIV Antiretroviral Effects Research (CHARTER)); and via a referral network of regional HIV care providers. for a total of four years 2012-2016.|
733552|NCT01561716|Thirty young healthy volunteers were enrolled in this randomized, crossover trial to examine the energy expenditure associated with Wii Fit and treadmill walking/running compared to sedentary resting between September 2009 and April 2010. Recruitment flyers were placed in the University of Rochester, Strong Memorial Hospital.|Each participant was assigned to a crossover sequence based on a computer generated randomization schedule using SAS 9.2. A washout period of at least 24 hours separated each study session.
733553|NCT01561703||
733554|NCT01561560|Participants were recruited from two study centers in Finland, three study centers in German, and three study centers in the UK.|Of the 123 participants enrolled, two were excluded prior to randomization. This reporting group includes all participants enrolled and exposed to Test Article (121).
733555|NCT01561495||
733556|NCT01561469||
733557|NCT01561430||As a result of findings from the I4O-MC-BACJ study (NCT01534273), enrollment was discontinued to the 15 milligrams (mg) arm. The 9 participants already enrolled were allowed to continue study treatment at the 15 mg dose.
733558|NCT01561378||
733968|NCT01534910|all 65 participants were recruited|
758022|NCT00178191|Recruitment started June, 2005 and completed Dec, 2007|
733559|NCT01561313||Two participants, who were randomized to the Current formulation adalimumab/New formulation of adalimumab arm of the study, were excluded from the analysis of injection site-related pain. One participant received one dose of study drug and discontinued because of an adverse event, while the other discontinued before receiving any study drug.
733560|NCT01561300|Forty five subjects were invited for screening. Two subjects did not come for the screening, three subjects were not willing to participate and three subjects did not fulfil the inclusion criteria. Of the 37 subjects that fulfilled all inclusion an exclusion criteria 30 were invited to participate.|Thirty subjects meeting all criteria were randomised over the two arms
733561|NCT01561079|Participants were recruited from a comprehensive care treatment facility for pregnant and postpartum women with substance use disorders between Feb 2012 and March 2016|Participants must have an opioid use disorder, a singleton, generally uncomplicated pregnancy, be between 18 and 40 years of age, have accurate gestational age dating of less than 34 weeks, willing to receive obstetric care at the center and deliver their infant at the hospital affiliated with the treatment facility.
733562|NCT01561053||
733563|NCT01560988||
733564|NCT01560975||
733565|NCT01560949|June 2012 to November 2015. All recruitment done at The University of Texas, MD Anderson Cancer Center.|A total of 34 participants enrolled in study 1 participant withdrew consent before initiating treatment.
733566|NCT01560923||One patient withdrew or refused to participate after receiving protocol therapy
733567|NCT01560871||
733568|NCT01560819|An open-label, uncontrolled, single-center, prospective pilot study was conducted at Helen DeVos Children's Hospital's outpatient gastroenterology center. Participants were enrolled between April and December 2012. Each participant took part in the study for 6 weeks. The study was not advertised.|Fifteen patients with ulcerative colitis (UC) were assessed for eligibility; all showed interest in the study. Ten participants met the eligibility criteria and the donors were identified by the participants.
733569|NCT01560780||
733570|NCT01560624||
733571|NCT01560507|Subjects were recruited from May 2012 until May 2013. We were only able to enter 19 of the 300 subjects into the study. We discontinued the study in July 2013 because of the recruitment difficulties.|Of the 19 subjects who signed a consent form: 9 subjects began study participation; 7 subjects were excluded prior to receiving study drug because of medical issues and 3 subjects met other exclusion criteria and were excluded prior to receiving study drug.
733572|NCT01560429|Patients were enrolled prior to thoracotomy. 52 patients were randomized to receive PCEA (n=26) or CEA (n=26).|
733573|NCT01560416|Participants were enrolled between June 2012 and June 2015|
733574|NCT01560403|This was a 1-year, open-label, multi-center study in subjects who completed Study CL0600-021 (NCT00930644) at any US site.|
733575|NCT01560377|A total of 147 patients were enrolled, of whom 139 were eligible for analysis. Patients were enrolled at 11 centers in the United States.|
733576|NCT01560286||
733577|NCT01560260||
733578|NCT01560234|There were 47 male and female subjects (6 cohorts with additional 2 cohorts) were randomized in the study.There were 6 subjects per cohort (4 subjects received AZD8848 and 2 subjects received placebo), with the exception of Cohort 3 (1.5 μg), where 3 subjects received AZD8848 and 2 subjects received placebo.|
733579|NCT01560143||
733580|NCT01559948|This study was a single blinded, mixed-design randomized clinical trial that was conducted in Dallas, Texas from January 2012 to December 2013. Thirty participants with SIJ pain who were not seeking medical care were recruited for this study via flyers and word of mouth marketing.|Exclusion criteria were current pregnancy or pregnancy in the last six months, history of surgery to the lumbar spine, pelvis, chest, or abdomen, history of congenital lumbar or pelvic anomalies, any neurological signs in the lower extremity, systemic arthritis, and history of pelvic fracture.
733581|NCT01559935||Two subjects were ineligible and therefore never started treatment.
733582|NCT01559922|199 subjects were enrolled into the Screening phase. 175 subjects were randomized, with a total of 147 subjects receiving study treatment. Data presented are from all Randomized/Treated subjects (i.e., n=147).|
733583|NCT01559857||
733584|NCT01559844|Participants were enrolled at study sites in the United States, Spain, and New Zealand. The first participant was screened on 27 March 2012. The last study visit occurred on 20 October 2014.|92 participants were screened.
733585|NCT01559675|Between September 2010 and March 2012, 121 patients with Inflammatory bowel disease (IBD) between the ages of 18 to 75 years taking corticosteroids, or previously treated with steroids within the previous 1 year, undergoing major colorectal surgery by a single surgeon at a single institution were recruited for this study|Of 258 patients assessed for eligibility, 137did not meet inclusion criteria. 9 patients refused to participate. 121 were then randomized to one of 2 study arms
733586|NCT01559649||Chart review-1042 suspected stroke patients . Excluded-636 (h/o neuro disease, etc). Eligible-406. 137-declined, d/c before approaching. Consented-269. Screening completed-258 (11-unable to complete screening-d/c, unstable, etc). VFSS completed-256-250 analyzed (6 excluded from analysis-equipment failure, h/o dysphagia, etc.). RNs-15 participated.
733587|NCT01559506||
733588|NCT01559454|Recruitment occurred between January 2012 and December 2013 at an ambulatory care medical clinic. Follow-up data collection lasted until May 2014|25 participants were assessed, but 6 were excluded for: unwilling to be randomized, DAST score below minimum, not opioid dependent, prior maintenance therapy, no prior surgery, and initial toxicology positive for cocaine (one patient per category)
733589|NCT01559389|Patients were recruited from March 2012 through July 2016 (52 months) from the Division of Female Pelvic Medicine & Reconstructive Surgery at Loyola University Medical Center.|
733590|NCT01559311|The enrollment target was 177 patients. There were 8 centers from Asia Pacific and 1 center from Italy in the study. From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study. Sample size was not reached due to difficulty in enrollment.|
733591|NCT01559259||
733592|NCT01559129||
733593|NCT01559116||This is a randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over design. Each patient was randomised to one of 30 treatment sequences. Each sequence consisted of four 6-week treatment periods separated by 3-week washout periods.
733594|NCT01559090||
733595|NCT01559064||
733596|NCT01559012|Patients admitted to hospital for severe hyperemesis (HG) March - December 2012|"The crossover study design allows to compare in the same patient the response to different treatment schedules.
~The assumption is that the condition treated is not changing over the time of observation.
~The reported evidence in literature is that severe HG does not spontaneously improve till 14th week."
733597|NCT01558791||
733598|NCT01558752||
733599|NCT01558739|54 patients were screened. 48 patients were enrolled as planned.|
733600|NCT01558700||
733601|NCT01558674||Study was terminated early due to lack of efficacy of MK-7145. Only 11 participants were enrolled and dosed in Part 1. Period 3 of Part 1 was not conducted. No participants were enrolled in the planned Part 2 of the study.
733602|NCT01558661|Protocol Open to Accrual 03-15-2012, Protocol Closed to Accrual 08-27-2013, Primary Completion Date 08-25-2016, Recruitment Location is the medical clinic|
733603|NCT01558635||
733604|NCT01558596|Recruitment period: From June 2011 to September 2015|A total of 205 patients were randomized, of which 201 received treatment. 4 patients removed from study after randomization
733605|NCT01558492||
733606|NCT01558297||
733607|NCT01558271||
733608|NCT01558128||
733609|NCT01558089||
733610|NCT01558063||
733611|NCT01557959||
733612|NCT01557946||
733613|NCT01557920||
733614|NCT01557894|The trial was briefly presented in various national and local newspapers, where a link to the project website (https://www.iterapi.se/sites/isofie) was provided. Interested participants registered online, read the informed consent, and filled in the screening questionnaires over the internet.|Of the 291 applicants 47 had high depression 35 had low social anxiety 38 could not be contacted 21 had long travel plans 10 declined participation 9 had other psychological disorders 8 were under 18 years 2 were redirected. Of the remaining 121 interviewed applicants, 66 meet the DSM-IV criteria for SAD, and 10 presented subclinical SAD symptoms.
733615|NCT01557881||
733616|NCT01557868||
733617|NCT01557842|The first and the last subject were enrolled on July 9, 2012 and on January 30, 2014 respectively. All ASPIRE sites were notified that the study was terminated due to ongoing enrollment issues on March 10, 2014. A total of 21 US study sites were activated with 7 sites enrolling subjects. The last follow-up visit was completed on April 21, 2014.|
733618|NCT01557790||
733619|NCT01557751||
733620|NCT01557699||
733621|NCT01557595||
733622|NCT01557582||
733623|NCT01557569||
733624|NCT01557517||
733625|NCT01557504||
733626|NCT01557400|The treatment gap between the date of administration of the last dose of ataluren in Study PTC124-GD-007-DMD (NCT00592553) and Study PTC124-GD-007e-DMD (NCT00847379) and the date of administration of the first dose of ataluren in this study (PTC124-GD-019-DMD) ranged from 114.43 to 266.14 weeks (801 to 1863 days).|Of the 94 enrolled participants, 44 were not ambulatory and 84 were on concomitant therapy with corticosteroids. Participants who were non-ambulatory were not able to run/walk 10 meters in ≤30 seconds at study entry.
733627|NCT01557348|This observational study was conducted in 11 countries from 02 June 2009 to 19 March 2012.|Of 1239 enrolled participants, 9 had no information on second biologic treatment/reasons for discontinuing prior tumor necrosis factor inhibitor (TNFi), 1111 had one previous TNFi,119 had more than one previous TNFi. Of 1111 participants, 728 were considered for primary effectiveness analysis (405 in Rituximab arm and 323 in Alternative TNFi arm).
733628|NCT01557322||
733629|NCT01557283||
733630|NCT01557166|The trial was conducted at 40 sites in 2 countries, as follows: United States: 35 sites; Canada: 5 sites.|The trial consisted of a 2-week screening period before randomisation.
733631|NCT01556997||
733632|NCT01556932|Participants recruited from Massey Cancer Center, in Richmond City, Virginia USA between March 2012 until May 2013.|25 participants were consented to the research study. Two of them no longer were nauseous and never started treatment. One subject expired on the study. 22 subjects enrolled but only 20 evaluable subjects' data was completed for analysis.
733633|NCT01556906|The study was performed from 05 Jun 2003 to 16 Feb 2004. The study was performed at a single medical clinic.|
733634|NCT01556763||
733635|NCT01556724||Forty-one patients signed an informed consent form. Eleven patients were excluded: six for inability to achieve <0.5mA quadriceps stimulation for lumbar plexus block placement and five for general anesthesia. After pharmacy randomization, 14 received ropivacaine 0.1% and 16 received ropivacaine 0.2%.
733636|NCT01556633|A total of 27 participants were screened and 16 participants were enrolled in the study. The study was conducted from 09 March 2012 to 23 June 2012 at two study centers in New Zealand.|
733637|NCT01556594|Participants were recruited from the clinical site's database and from participants who responded to advertising in local media.|
733638|NCT01556581||
733639|NCT01556451||
733640|NCT01556438||
733641|NCT01556425||
733642|NCT01556347|The candidates for this study were recruited from the clinic of the Inland Northwest Heart Transplant and Mechanical Heart Program at Providence Sacred Heart Medical Center in Spokane, Washington. The Study received final IRB approval Jan. 4, 2013 after having received FDA approval.|The potential candidates had to be accepted heart transplant candidates who met a stringent list of inclusion and exclusion criteria to become study candidates.
733643|NCT01556204||
733644|NCT01556165|Outpatients aged 35 years or older, who had idiopathic Parkinson's disease and were not treated with levodopa or other antiparkinsonian medications, were recruited for this study from China.|A Screening Visit was held approximately 28 days prior to group assignment (group assignment was held during the Baseline Visit). Patients who met each of the inclusion criteria and none of the exclusion criteria were eligible to participate in this study.
733645|NCT01556100||
733646|NCT01556061|The dates of the recruitment period were 6/1/11 -12/12/11. Patients were recruited in the Preoperative Day Surgery area and preoperative Holding Unit.|No enrolled patients were excluded from the study.
733647|NCT01556009||The PI has left the institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
733648|NCT01555983|Participants were enrolled via recruitment from the UC Davis Medical Center Spinal Cord Injury Clinic, IRB-approved recruitment letters and newspaper advertisements.|Screening for inclusion criteria (e.g., age > 18 and ≤ 70, pain intensity ≥ 4/10 and Leeds Assessment of Neuropathic Symptoms and Signs, a pain scale based on analysis of sensory description and bedside examination of sensory dysfunction. A threshold of ≥12 on this instrument was utilized to substantiate neuropathic pain.
733649|NCT01555957||
733650|NCT01555931||26 women failed entry criteria after delivery. Therefore although 61 were enrolled in the original study cohort, only 35 were randomized and allocated to one of the two treatment arms.
733651|NCT01555762|A total of 402 participants were enrolled from 100 French sites.|The data in the study for participant flow, baseline characteristics, outcome measure and adverse events was collected for overall participants and not as per the dose administered to participants.
733652|NCT01555697||
733653|NCT01555567||
733654|NCT01555541||
733655|NCT01555489||
733656|NCT01555463||
733657|NCT01555164|Participants were enrolled (during the Qualifying Period) at a total of 112 study sites in Canada, Europe, Asia, Mexico, South Africa, and the United States. The first participant was screened on 28 June 2012. The last participant observation occurred on 01 October 2013.|580 participants entered the qualifying period; 442 participants were randomized and treated, and comprise the Safety Analysis Set. Of these, 20 participants were excluded due to major eligibility criteria protocol violation or because the participant had no postbaseline data; the remaining 422 participants comprise the Full Analysis Set.
733658|NCT01555151||
733659|NCT01555138||
733660|NCT01555125|"Study terminated by Sponsor refers to the fact that - as per protocol - patients had to stop participating in the study in a given country where Secukinumab became available following approval."|
733661|NCT01555073||
733662|NCT01555021||Although clinicians were randomized to either receive or not receive the AGT results, they were not considered enrolled. Only the patients were enrolled in the study. Also, each participating clinician covered only one subject.
733663|NCT01554982||
733664|NCT01554904|Subjects recruited at the Shands Sleep Disorders Center through posted advertisement.|The inclusion and exclusion criteria and study protocol were discussed with potential subjects. Subjects who desired to participate and met criteria signed an informed consent.
733665|NCT01554891||This difference is due to screened patients who were enrolled, but then found ineligible,were unreachable, or withdrew from study.
733666|NCT01554683|While 12 participants were consented, 3 withdrew prior to receiving medications. 2 were due to claustrophobia preventing MRI and one was due to inability to recall why they were doing the study (so study was discontinued prior to drug administration).|
733667|NCT01554618|This study was conducted in adolescents (aged 10 to 17 years inclusive) with type 2 diabetes treated with diet and exercise alone or in combination with a stable dose of oral antidiabetic agents and/or insulin for at least 2 months prior to screening. 27 study centers in 6 countries randomized patients during the study.|Study had a screening period (5 weeks), controlled assessment period (24 weeks; patients randomized 5:2 to exenatide or placebo), open-label extension period (28 weeks) and post-treatment follow-up period (10 weeks). 84 patients were randomized but 1 due to clinical error and immediately discontinued, thus, 83 patients were included in the study.
733668|NCT01554579||
733669|NCT01554527|Of 120 consented, 105 were randomized to CPAP or control. (Of the 15 who weren't randomized, 8 were lost to follow up; the other withdrew for various reasons)|
733670|NCT01554488|subjects enrolled 3/12/2013-11/6/2015|28 subjects were eligible at V2 and entered the 2-week low dose fluticasone run-in phase, necessary to assess fluticasone adherence. Thereafter, three subjects withdrew consent and were not randomized. Thus, 25 subjects were randomized.
733671|NCT01554241||Following participant consent/enrollment, 4 were ineligible due to clinical instability or abnormal laboratory tests and one withdrew consent.
733672|NCT01554176|"One participant in the Filorexant 10 mg (Treatment Phase) arm did not receive study drug and was discontinued from the study; the reason given for discontinuation is given as non-compliance with study drug."|During the 1-2 week screening period participants will be evaluated to determine if they meet study entry criteria. The screening period will serve as a wash-out period for participants taking prohibited medications.
733673|NCT01554163||
733674|NCT01553916||
733675|NCT01553851||
733676|NCT01553747||3356 participants were prescreened and entered into interactive voice response system for participation in the study. 1146 participants were randomized. One participant was unintentionally randomized twice and was assigned 2 different participant identification numbers due to participant trying to participate at more than 1 study center at once.
733677|NCT01553708|All subjects were recruited between December 2011 to May 2012 at Burn Unit, Siriraj Hospital, Bangkok, Thailand.|The subjects were excluded if inclusion criteria was not met or the other treatment was assigned by the physician.
733678|NCT01553591||
733679|NCT01553539||
733680|NCT01553318||
733681|NCT01553292|The recruitment period was of 2 months duration form July 5th, 2012 to September 5th, 2012 in 3 hospitals (St Boniface NICU, Children hospital's NICU and Women's hospital delivery room at HSC).|
733682|NCT01553279|Infant participants were enrolled at 11 study sites in the United Kingdom.|
733683|NCT01553240|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|
733684|NCT01553201||
733685|NCT01553188||An initial run-I phase of AMG 386 will be conducted with 15mg/kg weekly escalating to 30mg/kg weekly to establish the maximum tolerated dose.
733686|NCT01553136||
733687|NCT01553084||
733688|NCT01553058||
733720|NCT01550965||A total of 463 participants were enrolled: 461 in the intent to treat (ITT) population were analyzed for efficacy (excluding 2 due to lack of post-baseline measurement data); 463 were analyzed for safety (participants who had received at least one dose of study drug).
733721|NCT01550952||
734011|NCT01532700|Study enrollment was stopped as of 13 Sep 2016. 28 patients were enrolled. Data analysis is complete and manuscript has been being submitted.|
734012|NCT01532648||
733689|NCT01552954|Patients were selected from 7 centers in Korea (Seoul National University Boramae Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Konkuk University Hospital, Dongguk University Ilsan Hospital, Kyung Hee University Medical Center, and Seoul St. Mary's Hospital) and enrolled from Mar. 2012 to Mar. 2013.|We screened 312 patients before 8 weeks of study initiation, and 269 patients were enrolled. During the 1st 8 weeks of this study (ARB run-in), 13 patients were withdrawn. After that, 256 patients were randomized, 11 participants were dropped out between 8th week and 16th week, and 245 who completed the trial were included in the analysis .
733690|NCT01552928||
733691|NCT01552915||
733692|NCT01552902|The study was conducted at 77 sites in the United States, Canada, and Europe.|Of the 778 screened participants, 229 were screen failures and 549 were randomized to treatment. A total of 547 participants were treated and the reasons for 2 'randomized but not treated' participants included withdrawal by 1 participant in the Methylphenidate group and 1 participant with a protocol violation in the Lisdexamfetamine group.
733693|NCT01552889||
733694|NCT01552876|Subjects are considered to be enrolled and not randomized at baseline. There were 42 subjects enrolled and 2 that were not randomized for a study baseline population of 40.|
733695|NCT01552772|Trial to assess the safety and tolerability of aripiprazole intramuscular (IM) depot as an adjunctive therapy in adults with schizophrenia who were stabilized on any one of the atypical oral antipsychotics other than aripiprazole. In the United States, the trial was conducted in 60 enrolled participants and were screened in 12 centres.|The study consisted of a 30-day Screening period, a treatment phase of 28 days, and a Follow-up at 30 days after the last trial visit. Participants must have been stabilized on one of the following atypical oral antipsychotic medications for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone.
733696|NCT01552694|38 participants were initially enrolled. 1 was lost to follow-up; 1 started a personal exercise training program while enrolled in the study. Any data collected on these 2 participants were excluded from the analysis. Both were initially enrolled in the placebo group.|36 participants completed the trial with complete data.
733697|NCT01552681|Participants were recruited from nine sites in the United States. The first site was activated in July 2012 and the last participant was randomized on 22 July 2014.|
733698|NCT01552603||
733699|NCT01552408||A total of 29 unique participants were enrolled in the study. 11 of these 29 had both eyes assigned to each intervention. Therefore, a total of 40 eyes were randomized in the trial.
733700|NCT01552369||538 liver transplant candidates or recipients were screened. 333 were not eligible. 229 did not meet inclusion criteria. 29 met at least 1 exclusion criteria. 75 unable to give, or refused consent. No study procedures were conducted on these 333 subjects.
733701|NCT01552343||A total of 67 subjects were screened and 11 subjects were screening failures: 5 due to signs of renal impairment, 4 did not have >=2 nocturnal voids every night in the 3-day screening period, 1 had uncontrolled diabetes mellitus, and 1 was leaving town for an undetermined period of time.
733702|NCT01552213||
733703|NCT01552057||Randomized participants who completed the 14-week treatment period were considered to have completed the study. After study completion or early discontinuation, participants completed a 1-week taper and were observed 1 week post-treatment for safety.
733704|NCT01551979||22 patients gave informed consent for the study during the initial screening visit. After patients were found ineligible to participate following review of medical records, withdrew consent, or were lost to follow-up, only 17 remained for the randomization phase and started the study.
733705|NCT01551888|"The study was conducted in a single center in the United States
~First patient visit was in January 2012 and last patient visit was in March 2012"|
733706|NCT01551758|This was a multicentre, randomized, stratified, open-label study to evaluate the effectiveness and safety of fluticasone fuorate (FF)/vilanterol (VI) in participants followed in primary care who had a diagnosis of and received regular treatment for Chronic Obstructive Pulmonary Disease (COPD).|Participants (par.) were randomized 1:1 to receive 1 inhalation of FF/VI 100 microgram (mcg)/25 mcg once daily (QD) or continued their existing maintenance therapy for 12 months. 2802 par. were randomized (3 par. randomized to the FF/VI arm did not receive study medication). A total of 2799 par. comprised the Intent to Treat (ITT) Population.
733707|NCT01551745|This study recruited subjects from CL-PTL-105 who recurred and were either randomized to the control/observation arm (Group B) or screen-failed but had successful manufacturing of Vigil (minimum of 4 doses).|5 subjects were enrolled and started Vigil treatment plus Bevacizumab. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1).
733708|NCT01551693|Patients enrolled from September 2011 to March 2012.|
733709|NCT01551550||
733710|NCT01551420||
733711|NCT01551355|Recruitment in 14 preschool facilities in Usaquén (Bogotá, Colombia) between May and November, 2009|
733712|NCT01551303|Adults aged 18 to 65 were recruited to the Massachusetts General Hospital through local email and print media advertising from March 2011 to September 2011.|No enrolled participants were excluded before group assignment.
733713|NCT01551212|In total, 642 patients were screened for study eligibility at 15 study centers in Germany. 339 patients were randomized out of which 333 received study treatment and were included in the analyses.|Patients were screened for eligibility prior to liver transplantation (LTx). The study treatment started after a run-in period that ended on the day of randomization, scheduled at Day 7-21 post-LTx. Patients may have been initiated on an optional induction therapy, MMF, TAC at investigators' discretion.
733714|NCT01551199||
733715|NCT01551186||
733716|NCT01551173||
733717|NCT01551095|Patients were enrolled between January 2012 and May 2012 in a tertiary academic center|
733718|NCT01551082|2 years in medical clinic|
733719|NCT01551056|Subjects were recruited from three sites in the US.|There were 91 subjects enrolled, 2 subjects discontinued, and 89 subjects completed the study. Participant flow and baseline characteristics are presented for the 91 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.
733764|NCT01548287||164 subjects signed informed consent and 83 failed to qualify at the first screening visit for participation in the study.
733765|NCT01548040||
734013|NCT01532635||
733722|NCT01550809|Twelve patients were recruited in this two-way, crossover study. One factor was the type of the insulin bolus administered (iBolus or tBolus). The other factor was the amount of carbohydrates (Low- or High-CHO meal) ingested. Recruitment started in February 2010 and was terminated by the end of June 2011|"Subjects received the i- or the tBolus on the first meal study (either Low or High CHO), according to one of the following sequences:
~iBolus first+low CHO first
~iBolus first+high CHO first
~tBolus first+low CHO first
~tBolus first+high CHO first
~Each one of the four meal tests was performed 1-2 weeks apart from the others"
733723|NCT01550757||
733724|NCT01550744|During this study, two subjects were transferred between sites and counted twice. Hence, a total of 478 subjects were enrolled in this trial.|
733725|NCT01550731|Veterans were enrolled from a women's, geriatrics, and several general medicine clinics at the San Francisco VA from April 2013 through July 2016. Veterans had to be 60 years or older, have had at least 2 chronic medical conditions, and had 2 or more visits with a primary care clinician, plus 2 VA clinic, ER, or hospital visits in the past year.|
733726|NCT01550705||
733727|NCT01550549|NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies|
733728|NCT01550510||
733729|NCT01550471||
733730|NCT01550367||
733731|NCT01550341||
733732|NCT01550302||
733733|NCT01550289|Study participants were enrolled from 27 March 2012 to 28 June 2012 at 5 clinical centers in India.|A total of 189 participants who met all inclusion and no exclusion criteria were randomized and vaccinated in this trial; 187 were included in the Full Analysis Set.
733734|NCT01550224||
733735|NCT01549977||Participants with a diagnosis of chronic stable angina were enrolled in 1 of 2 treatment groups, placebo or febuxostat 80 mg once daily.
733736|NCT01549964|Participants took part in the study at 168 investigative sites in Australia, Bulgaria, Croatia, Czech Republic, Hungary, Italy, Korea, Republic, Malaysia, Slovakia, Thailand and the United States from 05 April 2012 to 27 March 2014.|Participants with a diagnosis of Type 2 Diabetes Mellitus were randomly enrolled in 1 of 4 treatment groups in a 1:2:2:2 ratio, once a day placebo, 100 mg sitagliptin, 25 mg fasiglifam or 50 mg fasiglifam in combination with metformin.
733737|NCT01549951|Participants took part in the study at 16 investigative sites in Canada, France, Greece, Ireland, Romania, and the United States from 29 May 2012 to 21 January 2015.|Male participants with a historical diagnosis of metastatic castration-resistant prostate cancer (mCRPC) were enrolled in this single arm study to receive orteronel 400 milligram (mg) along with prednisone 5 mg twice daily for 28 days in each treatment cycle.
733738|NCT01549925||
733739|NCT01549873||
733740|NCT01549860||156 subjects were consented for the study, 112 subjects met the major inclusion/exclusion criteria (study cohort), 81 subject were randomized (reduced <30% during run-in period).
733741|NCT01549652|Chronic back pain patients were recruited from the San Francisco Bay Area via recruitment posters, newspaper advertisements, and radio and television announcements.|No enrolled participants were excluded from the study after enrollment and before assignment to groups.
733742|NCT01549613||
733743|NCT01549587||
733744|NCT01549405||
733745|NCT01549392||
733746|NCT01549340|This study involved a retrospective record review of patients in a private allergy and asthma practice who were recommended to receive allergen immunotherapy (AIT) to treat their allergic rhinitis (AR) by their physician between January 2005 and June 2011.|
733747|NCT01549314|27 subjects with CF taking ivacaftor were enrolled; however, 1 subject dropped out immediately after signing the consent form prior to any study procedures. No baseline data were obtained in this subject. Therefore, 26 subjects with CF taking ivacaftor were followed prospectively and were matched to the other 2 cohorts.|
733748|NCT01549275|From April 2010 to January 2013 in Cancer Center and Division of Hepatobiliary Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital|A total of 114 patients signed the inform consents. However, 9 patients were excluded due to negative cytological and pathologic results of malignancy in 4 patients, adenocarcinoma in 2 patients and fungal contamination during the preparation of the specimens in 3 patients.
733749|NCT01549223||
733750|NCT01549041|30 PATIENTS PARTICIPATED AND WERE RANDOMIZED 12 WERE RANDOMIZED TO ASENAPINE 10 MG QHS 18 WERE RANTOMIZED TO ASENAPINE 5 MG BID|
733751|NCT01549002||
733752|NCT01548885||
733753|NCT01548833|Participants were recruited from one study center in the United Kingdom.|This reporting group includes all enrolled participants.
733754|NCT01548768||
733755|NCT01548742|Participants were recruited through flyers posted in targeted clinics and clinical referrals at the Minneapolis VA Medical Center.|Participants completed a 5-hour eligibility and baseline assessment that included a structured clinical interview and self-report measures. Randomization occurred for those meeting study inclusion criteria.
733756|NCT01548690||
733757|NCT01548651||
733758|NCT01548638|Overall, since recruitment was initiated in March, 2012, 49 (45%) of the 109 completed phone screens resulted in a subject eligible for Intake. Of these subjects, 41 (84%) scheduled an in-person screening visit at our center.|Of the 29 subjects (73%) who attended the initial eligibility visit, 5 withdrew post enrollment (at visit), 11 were ineligible, and 13 subjects were deemed eligible.
733759|NCT01548599||
733760|NCT01548573||
733761|NCT01548417|Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, CA from 03/16/2012-03/14/2014. One Hundred twenty nine non-treatment seeking, paid volunteers signed informed consent, Fifty six subjects were enrolled, and Fifty four subjects completed the study.|Sixty six subjects were excluded from study participation due to exclusionary criteria, 2 subjects did not return after Visit 1, 4 subjects withdrew consent (2 for time constraints following Visit 1, 1 due to social motivations, 1 due to moving out of state), and 1 subject left the lab during Visit 1 when asked to provide a urine sample.
733762|NCT01548404|The study was conducted at 25 sites in Europe between 3 April 2012 and 25 June 2013. A total of 153 participants were screened in the study.|Out of 153 participants, 109 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive either Dupilumab 300 mg or placebo.
733763|NCT01548339||
733766|NCT01547806||Our study was a relatively small pilot study, with the primary emphasis being on expanding standard stem cell therapy options for patients with multiple myeloma. The plerixafor plus G-CSF combination is used relatively ubiquitously, and several larger studies relating to plerixafor have been performed at large centers that treat multiple myeloma.
733767|NCT01547728|Subjects were recruited from Mayo Clinic in Rochester, Minnesota.|
733768|NCT01547715|Subjects were enrolled from 3 study sites.|All the enrolled subjects were included in the trial.
733769|NCT01547598||
733770|NCT01547390||Of 1470 women screened, 138 were screen positive, and 53 consented to participate in the study and were randomized. Ten women in the aspirin group and 13 in the placebo group dropped out of the study.
733771|NCT01547299||
733772|NCT01547286|Subjects were recruited using an IRB approved advertisement from December 2012 - January 2013. Potential subjects completed two screening visits, during which the informed consent was obtained, clinical assessment, spirometry, methacholine challenge and allergic skin tests were performed. All screening visits took place at our pulmonary clinics.|This is a single group design study. Subjects were instructed to withhold their asthma and allergy medications before the screening and bronchial allergen challenge tests. The duration of the medication withholding depended on which medications they were using at that time.
733773|NCT01547247|"recruitment period - between March and May 2012
~consecutive patients referred to our endoscopic unit for diagnostic colonoscopy"|"a total of 275 subjects assessed for eligibility
~a total of 208 patients eandomized after exclusion of 67 due to not fulfilled inclusion criteria
~a total of 196 subjects analyzed after exclusion of 12 patients (poor bowel preparation, IBD, malignant obstruction, protocol deviation, ischemic colitis)"
733774|NCT01547130|This was a randomized, single-center, single-blinded (to the endoscopists) and active-control study. Patients undergoing elective colonoscopy between May 2008 and December 2010 were recruited. Location: Medical Clinic.|No events were recorded. None of the enrolled participants were excluded from the trial before assignment to groups. However, 14 no show ups for procedure were identified.
733775|NCT01547000||
733776|NCT01546922||Sixty-three patients were included in the study. Three patients withdrew from the study during the run-in phase, therefore a total of 60 patients started the first treatment period.
733777|NCT01546883|medical clinic|
733778|NCT01546688||
733779|NCT01546675||
733780|NCT01546649|Participants took part in the study at 21 investigative sites in Japan from April 2012 to December 2014.|Participants with a historical diagnosis of premenopausal breast cancer were enrolled in 1 of 2 treatment groups as follows: TAP-144-SR(6M); TAP-144-SR(3M)
733781|NCT01546636|A total of 70 patients presenting for elective shoulder surgery at NorthShore University HealthSystem were enrolled in the clinical trial.|All enrolled participants completed the study, and complete data was collected on all subjects.
733782|NCT01546623|Participants took part in the study at 23 investigative sites in Japan from 11 April 2012 to 04 April 2014.|Prostate cancer patients previously treated with hormonal therapy were enrolled in 1 of 2 treatment groups. Two patients withdrew from the period between randomization and starting study drugs (1 in TAP-144-SR(6M) arm and 1 in TAP-144-SR(3M) arm).
733783|NCT01546519|This was an open-label study with no randomization. Participants were categorized according to their baseline renal and hepatic function, and assigned to one of the five cohorts.|After assessing the additional data since the study initiation and after discussions with regulators, the sponsor concluded that renal impairment does not impact the pharmacokinetics of vismodegib and, therefore, a dedicated renal impairment cohort was eliminated.
733784|NCT01546454||One enrolled participant was lost to follow-up prior to receiving any interventions.
733785|NCT01546402||
733786|NCT01546285|Healthy subjects were recruited from 03.07.2012 - 03.23.2012 from Clinimark LLC, an independent physiology lab.|Subject distribution requirements (i.e. gender, blood pressure, and arm circumference)were reviewed as part of screening prior to subject enrollment.
733787|NCT01546207|Patients were recruited from 12/2011 to 7/2013, at a medical clinic at MSSM.|
733788|NCT01546194||
733789|NCT01546168|Recruitment began in November 2011, with enrollment beginning February 2012|88 participants were consented, but 2 withdrew prior to randomization
733790|NCT01546155||
733791|NCT01546142|The study was performed at 35 investigational centers in the United States (US) and Canada.|
733792|NCT01546038||Phase 1B:Unfit(unfit for intensive chemotherapy)participants with prior decitabine or azacitidine for high risk MDS or AHD(antecedent hematologic disease)were eligible for the LDAC arm only;with prior cytarabine were eligible for decitabine arm only.Phase 2:Participant's treatment arm assignment was based on the fit or unfit status at screening.
733793|NCT01545843||
733794|NCT01545817|A total of 74 patients were enrolled, all started first-line pazopanib treatment. Of these, 51 discontinued pazopanib and 38 continued to second-line everolimus treatment|
733795|NCT01545765|31 healthy volunteers have been enrolled in one Phase I center at USA.First subject in: May 3d 2012; Last subject ou: May 26th 2012.|
733796|NCT01545700|This study was conducted at NorthShore University HealthSystem (a single tertiary medical center affiliated with the University of Chicago Pritzker School of Medicine) and was registered with ClinicalTrials.gov (NCT #01545700). Participants were recruited by reviewing operating room schedules and contact by telephone on the day before surgery.|A total of 200 patients were enrolled in this clinical trial.
733797|NCT01545648||
733798|NCT01545583||
733799|NCT01545518|Patients enrolled in a medical setting if eligible. Inclusion and exclusion criteria. A total of 20 patients with unexplained refractory epilepsy were screened and tested with a multiple panel for anti-neuronal antibodies.|In comparisons with our original futility criteria, it was apparent that the absence of more powerful findings, and the time it took to collect the ones we have, indicated the virtual impossibility of identifying enough patients with strong autoimmune findings to carry out Phase 2 of this study.
733800|NCT01545388||
733837|NCT01542788|Participants were enrolled at 54 sites in the North America, Australia, and New Zealand. The first participant was screened on 07 March 2012. The last participant observation was on 04 February 2013.|410 participants were screened and 280 were randomized. Of those participants randomized, 278 received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
733801|NCT01545375|"1806 subjects were enrolled in this study, Three sub-cohorts of subjects were foreseen: Immuno/reacto sub-cohort for assessment of immunogenicity, Carriage sub-cohort for assessment of impact on carriage of S. pneumoniae and No additional procedures sub-cohort comprising subjects not included in any of the above sub-cohorts."|Out of the 1806 subjects enrolled in this study, 1803 were vaccinated and therefore included in the Total Vaccinated Cohort. 3 subjects were excluded for the following reasons: one subject had an invalid Inform Consent form and 2 subjects received subject number but did not receive any vaccine dose.
733802|NCT01545336||
733803|NCT01545232||
733804|NCT01545193||
733805|NCT01545141|9 Patients were enrolled in Phase I. 6 Patients were enrolled in Phase II prior to study termination (funding).|
733806|NCT01545076||
733807|NCT01544998|Participants were recruited at the Mayo Clinic in Rochester, Minnesota.|2 participants in the Preclinical Systolic Dysfunction group withdrew from the study before they were randomized. No participant in the Preclinical Diastolic Dysfunction group withdrew.
733808|NCT01544920||
733809|NCT01544595|"Among the 1146 patients who completed the screening phase, 995 PASI 75 responder at week 52 patients were randomized in a double blind fashion to either active treatment or placebo & entered the randomized withdrawal period and 151 partial responders at week 52 patients entered treatment period of the Extension."|1366 patients who completed the core studies (CAIN457A2302 or CAIN457A2303) and provided consent for participation in the extension study were screened, and 1146 (83.9%) completed the screening phase and entered the extension.
733810|NCT01544582||Of 713 Chronic Hepatitis C (CHC) participants included in the study, 679 were included in the Analysis Population and 34 were excluded. The Analysis Population comprised participants receiving Boceprevir plus peginterferon and ribavirin (PR), Telaprevir plus PR, or PR alone.
733811|NCT01544491|Full Analysis set (FAS) 106 enrolled and randomized patients except misrandomized Per Protocol set (PPS) 90 patients in the FAS without major protocol deviations Safety set (SAF) 106 randomized patients who received at least one dose of study drug|
733812|NCT01544478|A total of 1036 participants were screened and 1030 were enrolled in the study.|
733813|NCT01544361||Out of 125 participants enrolled, 32 participants were randomized to treatment.
733814|NCT01544348||A total of 295 participants were screened, out of which 209 were screen failures and 86 were randomized.
733815|NCT01544309||
733816|NCT01544179|A total of 265 (100%) patients randomised were from 61 centres in 11 countries: 133 patients to the gefitinib group and132 patients to the placebo group. Patients received maximum of 6 cycles cisplatin plus pemetrexed chemotherapy in addition to the randomised treatment (gefitinib or placebo).|265 patients were randomised. Randomised patients had epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and who had progressed on first-line gefitinib treatment
733817|NCT01544166|Pediatric subjects who were less than (<) 2 years of age, scheduled to undergo contrast-enhanced magnetic resonance imaging (MRI) for routine diagnostic purposes were included in the study and were recruited from 9 centres in Canada, Germany and United States of America.|Total of 47 subjects were screened worldwide in the study and 44 were enrolled (i.e. assigned to study drug). It included 3 screening failures (3 patients were not treated and did not complete the study).
733818|NCT01544153||
733819|NCT01544127||
733820|NCT01544114||A total of 51 participants signed informed consent; 5 participants were not assigned to treatment (eligibility criteria not fulfilled).
733821|NCT01544088||
733822|NCT01544062||
733823|NCT01544023||
733824|NCT01543958|A5296 accrual opened under protocol version 1.0 on 11/21/11, and the first subject was enrolled on 12/29/11. Accrual to the study closed on 8/1/12, with a total of 40 subjects enrolled from 15 sites within the US.|
733825|NCT01543828||
733826|NCT01543776||
733827|NCT01543685||
733828|NCT01543607||
733829|NCT01543581|The dates of the recruitment period in this study were Dec. 12,2011 through November 2012. Prospective subjects were seen in Loma Linda University Dermatology Clinic and were also seen prior to being referred to Loma Linda at Riverside County Regional Medical Clinic.|One subject signed the consent and was enrolled and completed the study. Two others signed the consent but were unable to continue their enrollment as one found out that he had Parkinsons Disease and the other could not arrange for transportation.
733830|NCT01543568|Patients were recruited from March 2012 to September 2012. 50 subjects from 1 site of the United States from a medical clinic. Each subject was was over 50 years of age, diagnosed with choroidal neovascularization secondary to AMD, and had a history of treatment with 0.5 mg ranibizumab followed by 2.0 mg ranibizumab for AMD.|
733831|NCT01543503|This observational study was conducted at 158 sites in 16 countries from 9 February 2012 to 20 February 2015.|A total of 1250 participants were screened for entry into the study, with 1225 participants enrolled in the study. One participant whose randomization status was unknown withdrew informed consent.
733832|NCT01543204|This study was conducted at 48 centers in the United States (US) and Canada. Participants were enrolled from 01 February 2012 until 04 November 2014.|
733833|NCT01543178||The screening phase included a 10 (±3) day run-in treatment period, during which subjects received single-blind placebo and completed a daily IBS symptom diary. Subjects who had active symptoms of IBS with diarrhea, and satisfied other entry criteria, entered the open-label period of study.
733834|NCT01543087|Total 698 participants enrolled in this extension study, who were enrolled in any 1 of the primary studies B1971010 (NCT01323270), B1971012 (NCT01299480), and B1971015 (NCT01461980).|This study consisted of 2 stages: Stage 1 and Booster stage. Only participants from primary studies B1971010 and B1971012 who received bivalent rLP2086 in the primary study and completed Stage 1 in this study, were eligible to participate in the booster stage.
733835|NCT01543074|34 Subjects consented for the study at the Linus Pauling Institute clinic, Corvallis, Oregon during the period February, 2013 to November, 2013. However, only 23 who qualified the criteria in the pre-screen blood tests were selected for the study.|
733836|NCT01542957||
733838|NCT01542684|Recruitment Period: 3/15/2012 through 1/14/2013. All participants recruited at The University of Texas MD Anderson Cancer Center.|
733839|NCT01542645||
733840|NCT01542632|Participants took part in the study at 3 investigative sites in the United States from 23 January 2012 to 10 January 2014.|Participants were enrolled in 1 of 6 treatment groups (GRP). GRP1: 1 dose TDV on Day 0 and 90, GRP2: 2 doses of TDV on Day 0, GRP3: 2 Doses of TDV on Day 0 and 1 dose of TDV on Day 90, GRP4: 1 Dose of TDV New Formula on Day 0 and 90, GRP5: 2 doses of TDV New Formula on Day 0 and 90 and GRP6: 1/10 dose of TDV on Day 0 and 90.
733841|NCT01542541||
733842|NCT01542528||
733843|NCT01542502||
733844|NCT01542398||
733845|NCT01542372|Patients were recruited in primary care clinics|In Step 1 of the protocol, patients were given an SSRI/SSRN to determine eligibility for Step 2. If a patient still had PTSD (PCL > 30) after Step I, the patient was assigned to an arm of Step 2, which was Medication or CBT augmentation. Of 114 patients started in Step I, 22 met criteria for entry to Step 2, the study proper, addressing study aims.
733846|NCT01542307|22 subjects enrolled|22 subjects enrolled - each subject generated data for one or more migraine attacks.
733847|NCT01542255|Enrolled from 6/2010 to 11/2012 at Dartmouth Hitichcock|
733848|NCT01542229||
733849|NCT01542125||
733850|NCT01542034|The study was performed at 35 investigational centers in the United States (US) and Canada.|
733851|NCT01541969|"First patient first visit, 28 May 2012
~Last patient last visit, 26 February 2014"|217 screen fails: Ménière(6), neuroma(2), TMJ(3), hearing loss(2), new hearing-aid user(11), recent hearing-aid adjustments(2), severe anxiety(4), severe depression(5), pulsatile TI(7), somatic TI(17), intermittent TI(7), slight TI(35), catastrophic TI(6), pitch match not possible(7), pitch out of fitting range(56), prescription tones inaudible(47)
733852|NCT01541930|April 2012 to December 2012 in Japan|
733853|NCT01541917||For this trial, 305 patients consented (were enrolled) to participate, but 7 of these patients subsequently were found to not fully meet eligibility criteria and 9 of these patients dropped out prior to being randomized. The total randomized sample therefore is 289.
733854|NCT01541891|30 patients were enrolled in this study at 1 hospital|Elegible patients were de novo patients diagnosed with mild to moderate dry eye disease
733855|NCT01541865|Enrollment of up to 150 subjects was planned; 146 subjects were enrolled at 23 centers in the Europe, Australia and New Zealand from February 22, 2012 to April 8, 2013.|
733856|NCT01541826||
733857|NCT01541748||Seventy-four subjects were consented. Five subjects did not meet inclusion/exclusion criteria and one subject was not implanted with a study device.
733858|NCT01541735||
733859|NCT01541644||
733860|NCT01541553||A total of 367 subjects were enrolled of whom 38 were screen failures. The remaining 329 subjects were randomised at Visit 1.
733861|NCT01541397||
733862|NCT01541384||
733863|NCT01541371|Participants were recruited from 19 study centers between 30 July 2008 and 23 September 2009.|405 participants were enrolled, out of which 403 participants were recruited in Safety Analysis Set (randomized and took at least 1 dose of study drug) and 394 subjects were included in full analysis set (had at least 1 efficacy evaluation).
733864|NCT01541358||
733865|NCT01541254||
733866|NCT01541215|The trial was conducted at 84 sites in 25 countries.|Eligible subjects entered an 11- to 12-week run-in period where they were to undergo a 3-4 week titration of metformin to a maximum tolerated dose of metformin (≥1000 mg and ≤2000 mg per day) followed by an 8-week maintenance period.
733867|NCT01540981||
733868|NCT01540851|Subjects were recruited from a tertiary academic medical center in Boston, MA|
733869|NCT01540838|"1128 patients were assessed for eligibility at the Hospital´s Emergency Service from Jan 2012 to Jan 2017.
~753 were excluded and 375 enrolled and randomized."|
733870|NCT01540825||
733871|NCT01540773|Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.|16 participants recruited; 16 Screened, 0 excluded
733872|NCT01540565|Study opened to patient entry April 2012 and closed to accrual November 2012.|
733873|NCT01540513|Participants were enrolled from March 2012 to September 2014 at the University of Wisconsin Hospital and Clinics.|
733874|NCT01540487||
733875|NCT01540409|The study was conducted at 12 centers in the United States. Overall, 12 participants who completed parent study 4658-us-201 (NCT01396239) were enrolled between July 2011 and February 2012 in this extension study (4658-us-202; NCT01540409). A 4-week open label period (Week 24-28) was observed between the parent and extension study.|Participants who received placebo in 4658-us-201 study were randomized in 1:1 ratio in this extension study to receive either eteplirsen 30 or 50 milligram per kilogram (mg/kg) and, those who received eteplirsen 30 or 50 mg/kg in 4658-us-201 received same treatment in this extension study.
733876|NCT01540370||
733877|NCT01540266||
733878|NCT01540162||
733879|NCT01540045|We recruit patients since September 2010 to July 2012|We invited to participate 40 patients who completed their baseline evaluation and their follow up after two cycles of chemotherapy using paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). The main reason of exclusion was death followed by not returning to the institution.
733880|NCT01539980||
733881|NCT01539837||
733882|NCT01539811||
733883|NCT01539759||
733884|NCT01539694|A total of 126 participants (252 eyes) were enrolled. One-half of the participants were randomized to receive the investigational contact lens during the first crossover period, and the other half were randomized to receive the PureVision contact lens during the first crossover period. The participants crossed over to the other group at 1 week.|
733885|NCT01539642|Recruitment period of 10 months - March 1, 2012 to December 28, 2012; Recruitment and screening occurred at clinical research centers and hospitals.|"Patients were excluded per protocol exclusion criteria at Screening as well as post surgery for certain issues including the following:
~Patients who were not awake or stable
~Patients with arterial oxygen saturation that couldn't be maintained at 95% or greater
~Patients with uncontrollable vomiting"
733886|NCT01539590||
733887|NCT01539538||
733888|NCT01539525|Participants were women (non-pregnant and pregnant) presenting for outpatient reproductive healthcare in an urban academic hospital-based clinic. Data collection occurred between April 20, 2011 and January 28, 2015.|
733891|NCT01539291|Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 03 October 2012. The last study visit occurred on 29 June 2018.|Participants must have been enrolled in Gilead-sponsored Study GS-US-312-0116 (NCT01539512) to be eligible to continued access to idelalisib (IDL) in this study.
733892|NCT01539239|Patients were screened and enrolled at 38 investigational sites in the United States and other countries.|Of the 1,143 enrolled, 572 were screen failures and 15 were excluded intraoperatively due to failure to meet all intraoperative eligibility criteria. At the time of reporting, 556 patients randomized are available for analysis.
733893|NCT01539135||
733894|NCT01539083||The study consisted of 2 treatment phases: induction and consolidation. Participants who completed the induction phase were randomized to enter in the consolidation treatment phase.
733895|NCT01539070|Study staff screened 3095 children from March, 2012 to October, 2012 in Mexican Institute of Social Security (IMSS) clinics (Intervention (Ix) n=2111; Usual Care (UC) n=984). Staff approached parents and caregivers in the waiting rooms of clinics, weighed and measured children and parents completed a baseline questionnaire to determine eligibility.|Of the 3095 (Ix n=2111; UC n=984) children initially screened, 1406 (Ix n=984; UC n=422) were eligible to participate and 306 (Ix n=168; UC n=138) agreed to participate. Of these 306, 189 (Ix n=93; UC n=96 control) participated in both the 3 and 6 month follow-up.
733896|NCT01538862||
733897|NCT01538719||2 subjects withdrew consent and 3 found to be ineligible, leaving 19 for randomization.
733898|NCT01538615||Total study enrollment was 413. Of those, 93 were enrolled in focus groups designed to help develop an disseminate the study. The remaining 320 took part in the HOME Plus study as described 81 parent/child dyads were randomized into the intervention condition and 79 parent/child dyads were randomized into the control condition).
733899|NCT01538472|Recruitment Period: September 30, 2003 to September 17, 2007. All participants enrolled at the University of Texas (UT) MD Anderson Cancer Center.|
733900|NCT01538199|Participants were recruited in 2012 for the pilot phase of the study. Participants were recruited from February 2014 through June 2015 via Craigslist advertisements and the general research phone line for the Depression Clinical and Research Program at Massachusetts General Hospital.|10 subjects from the pilot phase and 9 subjects from phase 2 screen failed (HAM-D scores below or above threshold, active substance abuse, exclusionary comorbid medical disorder, did not pass drug screen, just started psychotherapy). 6 participants dropped out after screen (time constraints, moving, LTFU). 1 subject had primary diagnosis of PTSD.
733901|NCT01537900||
733902|NCT01537887||Participants were randomized to 1 of 6 treatment sequences in a crossover design with 3 treatments; 1200 mg LY2484595, then placebo, then moxifloxacin. There was a washout period of ≥14 days between each dose. Participants were dosed 3 times during the entire study.
733903|NCT01537835||
733904|NCT01537783||
733905|NCT01537666||
733906|NCT01537549||
733907|NCT01537432||
733908|NCT01537419||
733909|NCT01537393||Randomization was at eye level. When both eyes of a participant were included, the eye undergoing surgery 1st was assigned randomly to a PT group and the 2nd eye to the other group. 2 eyes had their assigned donor corneas inadvertently switched, and resulted in 1 of these participants receiving both study eyes from 8-14d group.
733910|NCT01537367|Recruitment occurred from June 15, 2010 through February 11, 2011. Recruitment time varied from 6 months to 8 months, by clinic site. Recruitment always occurred during regularly scheduled primary care appointments, either in a private corner of the waiting room, or in an adjacent room of the clinic.|No exclusions from the trial if participant was deemed eligible and agreed to participate. Once participants were deemed eligible, and agreed, they were escorted to a private room to do the audio-CASI questionnaire. After the audio-CASI was completed they were immediately randomized to one of the three arms.
733911|NCT01537315||
733912|NCT01537302||
733913|NCT01537211||
733914|NCT01537198||A total of 618 participants were enrolled; 1 participant was a duplicate enrollment and the duplicate data was excluded from the analysis.
733915|NCT01537185||
733916|NCT01537133||Healthy controls and non-atopic asthmatics assessed only at baseline.
733917|NCT01537120||After enrollment, participants previously treated with both metformin and sulfonylurea, discontinued sulfonylurea usage and underwent washout of sulfonylurea over a period of 8 weeks prior to treatment. Non-washout participants were enrolled on a clinical regimen of metformin alone.
733918|NCT01537081||A total of 3215 patients were screened for enrollment, and 405 did not proceed in the study. Participants were randomized in a 2:2:1 ratio.
733919|NCT01537068||
733920|NCT01537042|The recruitment for the SP0934 study began in April 2012. It concluded in October 2013. This was a multicenter study with subjects enrolled by 9 sites across Europe and 6 sites across the United States.|The participant flow consists of the Randomized Set (RS), which is all subjects randomized into SP0934.
733921|NCT01537029||
733922|NCT01536951||The study had 2 parts. Part A: single-dose, dose-escalating study of LY3009104 [up to 40 milligrams (mg)] or placebo administered in each period. Part B: assessed the electrophysiological effects of a single supratherapeutic LY3009104 dose compared to a positive control (moxifloxacin) and placebo. Participants enrolled in either Part A or Part B.
733923|NCT01536938|First Subject First Visit: 07-MAY-2012 Last Subject Last Visit: 10-OCT-2012|Prior to randomisation, the subjects entered a washout phase (if required) where antipsoriatic treatm. and other relevant medication/treatms. had to be discontin. as defined by the excl. criteria. Depending on prior use of disallowed treatms, the washout/screening phase could last for up to 4 w prior to the first admin. of investigational products.
733924|NCT01536886|First Subject First Visit: 10-May-2012 Last Subject Last Visit: 19-Sep-2012|Prior to random., the subjects entered a washout phase (if required) where antipsoriatic treatm. and other relevant medication/treatms. had to be discontinued as defined by the excl. criteria. Depending on prior use of disallowed treatms, the washout/screening phase could last for up to 4 w prior to the first admin. of investigational products.
733925|NCT01536860|A total of 11 subjects completed the study. The study was conducted at one clinical research site and study started February, 2012 and was completed in March 2012.|This was a randomized double blind cross-over study. There was a wash out period of 3 or more days between interventions.
733927|NCT01536587||At Visit 1, a complex data registration was performed during which placebo and 50 micrograms (µg) salmeterol via SEREVENT DISKUS inhaler was administered sequentially. Following Visit 1, participants were treated with salmeterol 50 µg twice daily (BID) via DISKUS inhaler for 4 weeks.
733928|NCT01536574||Participants who completed 24 weeks of randomized treatment in parent Study ROP111528 (NCT01154166) and 1 week of down titration at the end of treatment or at early withdraw were allowed to enter this extension study provided they had continued on study drug without a break.
733929|NCT01536561|After an initial treatment (IT), 14 participants (14 of the 59 particpants receiving the IT) who achieved a partial or complete response and subsequently developed progressive disease were retreated (administered at either the initial dose or a reduced dose if a >=Grade toxicity had occurred after the IT) at the time of disease progression.|Participants received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases: Phase 1, dosimetric dose; Phase 2, therapeutic dose. After radioimmunotherapy, participants could have entered a 10-year Long-Term Follow-Up study (Study BEX104526; NCT00240591) for continued evaluation.
733930|NCT01536535|Recruitment and enrollment began in July 2012 and ended in April 2015. Final study visits were in April 2016 at which time all study patients had a minimum of one year follow up. Patients were recruited from 29 centers in the United States and Canada.|Participants were consented at diagnostic colonoscopy obtaining biological specimens (DNA, serum, rectal tissue, stool for microbiome). After diagnosis of Ulcerative Colitis, they began treatment dictated by initial disease severity and provider/patient choice. Three patients were untreated.
733931|NCT01536496|The first patient was enrolled on 09/25/2010 and the last one was enrolled on 03/21/2014. The patients were enrolled when they met the inclusion criteria for the study, which were the criteria that activate the massive transfusion protocol. Enrollment occured upon arrival either in Emergency Room or in Operating Room.|
733932|NCT01536418|A total of 253 participants, having moderate-to-severe Active Crohn's Disease were randomized to the study. The study was conducted from 11 November 2011 to 17 October 2013, at 113 centers in 26 countries with sites in North America, Europe, Israel, Japan, Republic of Korea, Hong Kong, Taiwan, Australia and New Zealand.|
733933|NCT01536405||One participant was inadvertently randomized twice, for a total of 1413 randomizations. The Participant Flow reported below includes this participant only once.
733934|NCT01536379|A total of 30 renal transplant recipients were enrolled, of which 28 were randomized and 25 were transplanted.|Participants were randomized to 1 of the 2 treatments groups in a 1:1 ratio and received standard of care in addition to investigational products (IPs). Participants received IP infusion on Day 0, Day 14, Day 28 and every 4 weeks thereafter for a total of 7 infusions.
733935|NCT01536366||
733936|NCT01536262||This study was a 52-week multi-centre, randomised, double-blind and parallel-group design.
733937|NCT01536197||
733938|NCT01536184|The population studied were families with preschool children with FASD or PAE who were referred to the provincial FASD Outreach program or the FASD Family Support, Education and Counselling Program, a program of New Directions,between January 2011 - December 2013. The age range of children in the FASD Outreach Program is between 2 to 5 years old.|
733939|NCT01536171||
733940|NCT01536145||
733941|NCT01536119|Recruitment took place at on the postpartum unit of a large Toronto hospital between March 26th and July 15th 2012|Eligibility determined before recruitment into trial.
733942|NCT01536093||
733943|NCT01536067||
733944|NCT01536015|The total duration of the study was to be a maximum of 19 weeks for each subject, including the Screening Period (within 50 days prior to Day 1), the Titration Period (up to 3 weeks), the Maintenance Period (up to 7 weeks), and a Safety Follow-Up Visit. The Participant Flow refers to the Randomized Set which includes all randomized subjects.|A total of approximately 150 subjects were planned to be randomized in a 1:1 ratio to either Rotigotine or Placebo.
733945|NCT01535976|Hospital based recruitment. From August 2011 to June 2012.|
733946|NCT01535937||
733947|NCT01535807||
733948|NCT01535729||
733949|NCT01535664||
733950|NCT01535638||
733951|NCT01535599|Participants were recruited from 68 investigational centers located in the United States, Puerto Rico, and Canada.|Of the 768 consented participants, 75 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants (693).
733952|NCT01535573||
733953|NCT01535560|Participants were recruited from 53 investigational centers located in the United States, Puerto Rico, and Canada.|Of the 589 participants enrolled, 40 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants.
733954|NCT01535443||
733955|NCT01535365||
733956|NCT01535326||
733957|NCT01535287||
733958|NCT01535261||No data were excluded from the Full Analysis Set (FAS )analyses because of protocol deviations.
733959|NCT01535235||The trial over enrolled by one individual as one participant discontinued the study after enrollment due to an adverse event.
733960|NCT01535222||
733961|NCT01535118|A national probablility sample of 2765 adults & children (age 5+) who had ever been diagnosed with hay fever, allergic rhinitis, rhinoconjunctivitis, nasal allergies or eye allergies & had nasal allergy symptoms in the past 12 months or had taken prescription medicine for allergies were interviewed by telephone about their condition & treatment.|
733962|NCT01535053|The study was activated on 6/18/2012and closed to accrual prematurely on 9/20/2016 by the sponsor due to slow accrual.|Sites declared in advance which of 2 methotrexate regimens they would follow for patients who received a random treatment allocation to the methotrexate arm. Randomization is stratified by country (US, Canada, Japan, Korea, Australia, United Kingdom, etc.) and Multi-day methotrexate regimen (8- or 5-day) used by the participating site.
733963|NCT01535040||
733964|NCT01535014||
733965|NCT01535001||
733966|NCT01534975||
733967|NCT01534962||"A total of 310 patients were screened and underwent cardioversion (CV). Of these, 241 were still in sinus rhythm 2 hours post-CV and, thus, were eligible for randomization.
~Patients who experienced an atrial fibrillation (AF) recurrence could continue the study if no medical intervention was needed and otherwise had to discontinue the study."
733969|NCT01534897|Recruitment period: July 2012-July 2013 Location: Massachusetts General Hospital Cancer Center Medical Clinic Number of patients recruited: 10 Recruitment goal: 10|All patients recruited were enrolled, and all patients completed the study.
733970|NCT01534689||
733971|NCT01534676|This is a research study carried out at Columbia University Medical Center. Participants with a blood disorder and currently receive blood transfusions as treatment will be transfused fresh, stored, washed or frozen blood according to regular schedule for up to 3 years. Volunteer dedicated donors will also be asked to provide consent.|Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment.
733972|NCT01534663||Seventeen participants were randomized to the active treatment group and 14 to the placebo group. Three participants dropped out in the active treatment group. Two participants dropped out of the placebo group. A total of 14 participants completed the trial in the active treatment group and 12 in the placebo group.
733973|NCT01534637|The study began recruiting patients 08/31/2006 and closed to enrollment 12/03/2009. Patients were recruited from the Comprehensive Cancer Center of Wake Forest Baptist Health.|
733974|NCT01534533||
733975|NCT01534520|In total, 79 women presenting for IUD insertion at OPC, UPP, and GMO were approached for participation.|"2 patients were removed from the study. Patients were considered screen failures before randomization to an arm.
~18 declined participation; 10 (56%) reported time concerns as their primary reason for declining."
733976|NCT01534416|Patients undergoing laparoscopic surgery for benign indications were enrolled between 2011 and 2013|
733977|NCT01534351||Prior to early study discontinuation, 3 sites were initiated and screened a total of 8 participants. Of the 8 participants, one participant was randomized to finasteride 5 mg once daily for 39 days.
733978|NCT01534273||
733979|NCT01534260|This protocol was based on enrolling up to 44 patients with 2 to 30 patients in phase I and 14 patients in phase II. The study enrolled 37 patients with 17 in phase I and 20 in phase II.|
733980|NCT01534208||
733981|NCT01534195||
733982|NCT01534182|Participants at screening received standard DMT with either interferon beta-1a or glatiramer acetate from day -30 to day -1.|Eligible participants were then randomized in a 3:1 ratio to fingolimod or a standard DMT. For participants who were randomized to the standard DMT group, those who received IFN during screening were switched to GA at randomization and those who received GA during screening were switched to IFN at randomization.
733983|NCT01534143|Cancer center clinic.|
733984|NCT01534078||
733985|NCT01534052|The study was conducted at 1 site in the Republic of Moldova, 2 sites in South Africa and 4 sites in the United States. In order to participate, participants had to complete a prior study with enzalutamide, be in a state of at least stable disease and benefit from continued treatment with enzalutamide in the opinion of the investigator.|This was an extension study in prostate cancer participants who have received enzalutamide treatment in prior phase 1 studies. The 9785-CL-0121 was an extension of previous enzalutamide studies (9785-CL-0003 [NCT01902251], 9785-CL-0007 [NCT01911728] & 9785-CL-0406 [NCT02225093]).
733986|NCT01534013||
733987|NCT01533974||
733988|NCT01533948||
733989|NCT01533935||This was a randomised, 4-period incomplete block cross-over trial. 291 patients were randomized to one of five treatments sequences and treated. It was a double-blind trial in which each treatment period lasted 6 weeks with a washout period of 21 days between each.
733990|NCT01533922||This was a randomised, 4-period incomplete block cross-over trial. 295 patients were randomized to one of five treatments sequences and treated. It was a double-blind trial in which each treatment period lasted 6 weeks with a washout period of 21 days between each.
733991|NCT01533753|Subjects were recruited from medical clinic between the dates of 1/31/2012 and 5/9/2014.|
733992|NCT01533688||
733993|NCT01533597||
733994|NCT01533493||Of the 33 participants enrolled, 26 were randomized to receive the treatment. The remaining 7 participants were either lost to follow-up after signing consent (n=3) or withdrew consent before being randomized (n=4)
733995|NCT01533428||
733996|NCT01533259|Participants were enrolled at a total of 7 study sites in the United States. The first participant was screened on 31 January 2012. The last study visit occurred on 23 August 2013.|58 participants were screened.
733997|NCT01533246|18 patients were entered into the trial between February 2012 and April 2012 form local medical hospitals. One patient was considered ineligible and has been excluded from all analyses.|
733998|NCT01533207|This study accrued 38 patients from June 2012 to September, 2016. Study was closed due to accrual futility.|
733999|NCT01533181|Participants were enrolled at Moffitt Cancer Center and nine other institutions in the United States from July 3, 2012 through November 1, 2013.|
734000|NCT01533116||
734001|NCT01533077||
734002|NCT01533038||
734003|NCT01532999||254 participants signed informed consent; 214 participants were randomized; and 191 randomized participants attended at least one MBSR or PCGT session and were included in the modified intent-to-treat analysis for which results are displayed.
734004|NCT01532986|345 participants enrolled in the study. Subjects were identified by a treating provider while receiving care at 5 Veterans Administration health systems.|13 removed before baseline survey. 4 were ineligible due to not having Parkinson's disease. This left 328 who were randomized
734005|NCT01532973||2 Panels (Panel D in Part 1 and Panel H in Part 2) were planned but not performed. No participants were enrolled in either of these panels.
734006|NCT01532934|Recruitment took place at a jail diversion program in Upstate NY between 2009 and 2014.|Inclusion criteria were harmful substance use in the past 6 months and enrollment in a jail diversion program subsequent to being charged with a crime.
734007|NCT01532921||
734008|NCT01532869||Randomization was stratified by joint involvement at baseline (>=4 or <4 tender joints of 28 tender joint count [TJC]). The study consisted of double-blind (Week 0-Week 48) and open-label (Week 48-Week 96) periods. Data analyzed up to Weeks 24 and 48 (data cut-off: 11 July 2014), and up to Week 96 (data cut-off: 05 August 2015) are reported.
734009|NCT01532830||
734010|NCT01532817||
734014|NCT01532570||
758023|NCT00178178||
734015|NCT01532453|Of 244 patients enrolled, 3 patients were considered screening failures (003-006, 005-002 and 010-027). Patient 003 006 used forbidden concomitant medication. Patient 005 002 had severe sun damage of the skin, violation of exclusion criterion #5. Patient 010 027 was re-enrolled as Patient 010 029 and later randomized to the MD-3511356 group.|Of 244 patients enrolled, 3 patients were considered screening failures (003-006, 005-002 and 010-027). Patient 003 006 used forbidden concomitant medication. Patient 005 002 had severe sun damage of the skin, violation of exclusion criterion #5. Patient 010 027 was re-enrolled as Patient 010 029 and later randomized to the MD-3511356 group.
734016|NCT01532414||
734017|NCT01532388||
734018|NCT01532362||
734019|NCT01532349||
734020|NCT01532141||
734021|NCT01532128||
734022|NCT01532089||
734023|NCT01531998|Recruitment Period: May 10, 2012 to February 08, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the fourteen participant enrolled, three were screen failures and not enrolled on the study.
734024|NCT01531959||139 participants provided informed consent and were enrolled. 3 participants subsequently did no loner meet eligibility criteria and were therefore not randomized, resulting in a total number of started/randomized participants of 136.
734025|NCT01531894|As this was a rollover study, there was no planned number of subjects. Eleven subjects were enrolled and analyzed in the study.|There was no planned duration of treatment as this was a rollover study. The subjects could permanently discontinue the study treatment due to protocol deviation, adverse event, disease progression, withdrawal of consent, Investigator's discretion, lost to follow-up, termination of study or death.
734026|NCT01531738||
734027|NCT01531725|202 patients at 10 European sites have been enrolled.|Not group assignment.
734028|NCT01531673||A total of 194 participants were randomized of which 190 participants were treated.
734029|NCT01531439||
734030|NCT01531387||22 participants were randomized (e.g., a total of 38 participants enrolled, but only 22 participants were randomized to treatment)
734031|NCT01531374|Between February 21, 2012 and April 15, 2014, 1658 subjects were enrolled in the Continued Access Extreme Risk Study at 45 centers in the US. Between October 19, 2012 and August 12, 2014, 1119 subjects were enrolled in the High Risk Study at the same 45 US centers.|
734032|NCT01531335||
734033|NCT01531205|Participants were recruited at Moffitt Cancer Center from May 15, 2012 to September 27, 2013.|
734034|NCT01531153||
734035|NCT01530997|Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), and Rex Hospital (Raleigh, NC).|Sixty-nine patients were eligible for enrollment, of whom 45 were accrued. One patient had a cerebrovascular accident during de-intensified CRT and was taken off the study. After the completion of CRT, 1 patient refused the planned surgical evaluation, leaving 43 patients who were fully evaluable.
734036|NCT01530880||
734037|NCT01530477|A total of 17 subjects consented for the Skeletal Cohort only. A total of 12 subjects consented for the Body Composition Cohort only. A total of 53 subjects consented to participate in both the Skeletal and Body Composition cohorts. Recruitment occurred at the primary site from January to December 2012.|Subjects were able to consent and participate in one or both cohorts (Outcome Measure Reporting Groups: Skeletal and Body Composition). GE prematurely ended the study with 82 consented individuals but a total of 135 scans were acquired across the cohorts.
734038|NCT01530464|"Recruitment started on August 1, 2011, was stopped again after delays in acquiring study drug (ambrisentan), and commenced again on February 6, 2012, until April 14, 2012.
~The study was conducted in the Duke Clinical Research Unit (DCRU)."|The study was initiated on August 1, 2011 and stopped on August 9, 2011 after a delay in acquiring the study drug ambrisentan. None of the 24 screened subjects were randomized in this period. The trial was re-started on February 6, 2012 and completed on April 14, 2012 with the last subject being evaluated on April 30, 2012.
734039|NCT01530399||
734040|NCT01530334|Overall, 61 patients were enrolled from July 2012 to July 2014 from 25 medical clinics across Italy: of these, 59 received gefitinib.|The study foresees a screening period of 28 days where the investigator had to obtain signed informed consent from the potential patient before any study specific procedures are performed, and determine patient eligibility. At the end of the screening period the patient started the treatment with gefitinib
734041|NCT01530243||
734042|NCT01530178|10 participants were screened. 2 did not meet the criteria. Patients were recruited from diabetes clinics, via fliers, and online postings on clinical trial sites.|Only 2 subjects underwent the study visit using sitagliptin 25mg. As we did not see a significant difference between the doses of 25 mg and 50 mg of Sitagliptin, we therefore continued the study visits for other subjects using only 50 mg and 100 mg of sitagliptin
734043|NCT01530087||
734044|NCT01529827||
734045|NCT01529749||
734046|NCT01529645||
734047|NCT01529632|193 patients were randomized, with 187 of those completing the study. A total of 6 patients discontinued from the study.|Open-label, active QAB149 and NVA237 were administered during a 14-day period prior to randomization in order to stabilize patients and standardize baseline lung function. The patients were then randomized to either the fixed dose combination or free combination arms of blinded treatment in a 1:1 ratio and received study drug for 28 days.
734048|NCT01529606|Two more patients were recruited because patients received recruitment information and requested participation in the study.|
734049|NCT01529515||A total of 509 participants were enrolled in to the study and 506 participants were entered the Open-label Transition and received at least one dose of study drug (PP1M). 2 participants were enrolled but not received study drug and 1 participant was screen failure.
734050|NCT01529502||
734051|NCT01529450||
734052|NCT01529385||
734053|NCT01529346||
734054|NCT01529268|Patients were enrolled at 10 NASH CRN clinical centers from June 2012 to January 2014.|
734055|NCT01529203||
734056|NCT01529112||The participant flow is based on data cut-off date of 21 January 2014 as the study is ongoing.
734057|NCT01529060||
734058|NCT01529034||The participant flow refers to the enrolled population and includes participants who did not treat a seizure cluster episode.
734059|NCT01528969|Altogether 122 10-12-year-old boys, whose parents gave a positive consent, participated in the baseline examinations. The study was conducted at one school in Jabriya, Kuwait.|Str mutans was measured from plaque and saliva. Those children who had high mutans counts (n=75) were included into the intervention.
734060|NCT01528891||418 patients overall were enrolled in the study. Of these patients, 18 failed screening prior to randomization into either treatment arm.
734061|NCT01528878|Patients were enrolled from June, 2009 to March, 2014 at two institutions.|39 participants were consented and 9 were found ineligible and were not treated.
734062|NCT01528787||
734063|NCT01528735||
734064|NCT01528709||
734065|NCT01528696||
734066|NCT01528605||"We added High Zeaxanthin and High Lutein Zeaxanthin Arms at the seconde year for additional information on the effect of zeaxanthin on MPOD and visual functions. Therefore, we did not measure the changes of serum concentration, and only measured the change of MOPD and visual functions at baseline and 48 weeks, in the two new groups."
734067|NCT01528592|Recruitment period: 12/1/2011 - 4/30/2012 Location: Medical clinic in Chicago|
734068|NCT01528345||
734069|NCT01528332|Date of First Enrollment: 03-Feb-2012 Date of Last Patient Last Visit: 03-Jul-2012|
734070|NCT01528319||
734071|NCT01528293||
734072|NCT01528254|It was planned to screen approximately 4000 patients in order to randomize 2000 patients. Actually, 2001 patients were randomized, 998 patients into the Vilda 50mg bid + metformin group and 1003 into the placebo + metformin group.|
734073|NCT01528228||
734074|NCT01528215||
734075|NCT01528150||
734076|NCT01528124||
734077|NCT01528072||In the time between signing consent and application of treatment 13 subjects were discontinued. Out of 153 enrolled there were: 5- screen failures; 1- withdraw consent; 5- insurance denials; 2- Removed by investigator.
734078|NCT01528033|Patients were enrolled betweenAugust 2, 2011, and January 31, 2018 in 34 abdominal surgical departments of hospitals in Germany, Belgium, and the Netherlands|
734079|NCT01527942||
734080|NCT01527682|Consecutive Primary Congenital Glaucoma not sufficiently responder to a single surgical procedure|Patients affected with Primary congenital glaucoma will be recruited if after a single surgical procedure Intraocular pressure will be ranging from 22 and 27 mm Hg
734081|NCT01527513||
734082|NCT01527500|"Study conducted in 2 parts: Part A & Part B.
~Part A evaluated safety & efficacy of multiple 5 mg/50 µL doses of intravitreal (IVT) LFG316 against sham every 28 days for 505 days
~Part B evaluated the safety and pharmacokinetics of a single IVT dose of 10 mg/100 µL of LFG316"|
734083|NCT01527487|This neoadjuvant trial evaluated the combination of eribulin/cyclophosphamide (ErC) versus docetaxel/cyclophosphamide (TC) in women with clinical stage II-III breast cancers. Between JUN 2012 and APR 2014, 76 patients were enrolled.|After a 10-patient lead-in to confirm safety and feasibility of ErC, subsequent patients (66) were randomized 2 to 1 for treatment with: (1) ErC (44 patients) or (2) TC (22 patients). Both regimens were administered every 21 days for 6 cycles followed by surgery.
734084|NCT01527383||A total of 362 participants were screened and 354 were enrolled.
734085|NCT01527370|Ten sites in India enrolled adult participants in the study.|
734086|NCT01527357|Participants were enrolled from May 2012 to April 2013 at 57 investigative sites (United States, n = 28; United Kingdom, n = 12; The Netherlands, n = 11; and Belgium, n = 6), and were randomized 2:1 to receive treatment with Fibrocaps plus gelatin sponge or gelatin sponge alone.|After screening, 719 eligible participants had surgery in 1 of 4 surgical indications (i.e., spinal, hepatic, vascular, or soft tissue dissection) on Day 1 according to local standard practice, and received treatment with the investigational product assigned.
734087|NCT01527292||
734088|NCT01527162||
734089|NCT01527149||
734090|NCT01527110|The study was planned on 20 male or female participants, aged 16 years or older years, across 6 centers of Japan from 11 January 2012 to 29 March 2013.|A total of 21 hospitalized Japanese participants with laboratory confirmed influenza were enrolled to receive intravenous (IV) zanamivir 600 milligram (mg) twice daily (BID) for 5 days. The course was extended for up to 5 additional days based on ongoing viral shedding or clinical symptoms requiring treatment.
734091|NCT01527045||
734092|NCT01527006||Of the 63 participants who were enrolled, 13 participants were screen failures and 50 participants were eligible to continue in the Core Study. Of the 42 subjects who completed the Core Study, 41 subjects continued into the Extension Phase.
734093|NCT01526928|There were 612 patients who received rociletinib-111 enrolled in Phase 1 and 501 enrolled in Phase 2. The Phase 1 component of the study was conducted at 8 study sites in the US, Australia, and France. Phase 2 was conducted at 49 study sites in the US, France, Poland, and Australia.|
734094|NCT01526902|Recruitment was open between 06FEB2012 and 28FEB2012|The subjects who are current contact lens wearers should attend the first visit wearing their habitual lenses and having worn them that day for at least 2 hours prior to the visit.
734095|NCT01526889||Approximately 24 patients were planned to be enrolled. A total of 25 patients were randomized (18 patients in LFG316 group and 7 patients in conventional therapy group).
734096|NCT01526785||The study was conducted in the United States. A total of 113 participants were treated between 9 March 2012 and 4 June 2014.
734097|NCT01526733||
734098|NCT01526629||
734099|NCT01526577|"Recruitment location: Seoul University Hospital
~Recruitment period:
~Single dose study recruitment period: 12Mar2012 ~ 18Sep2012
~Muti-dose study recruitment period: 02Dec2012 ~ 05Aug2013"|The subjects were enrolled in single dose study and multiple study separately. The subject enrolled in single dose study was not allowed to be enrolled in multiple dose study.
734100|NCT01526551||
734101|NCT01526538||
734102|NCT01526356||
734103|NCT01526343|A total of 47 consecutive patients who received an implantable loop recorder (ILR) after a surgical ablation procedure were followed between August 2011 and January 2014. Patients with AF who were scheduled to undergo elective surgical ablation procedure that included a CM IV lesion set or pulmonary vein isolation were eligible.|
738152|NCT01277081|Participants were recruited at the clinical site.|A total of 200 participants were screened and all were randomized into the study.
734104|NCT01526213|Screening began in September 2009. Potential eligible subjects presented for a screening visit at the UNC Clinical and Translational Research Center (CTRC) within 1 month prior to the first day of the study.|No significant events/approaches for overall study following participant enrollment but prior to group assignment. 18 subjects recruited and screened. No exclusions.
734105|NCT01526148||
734106|NCT01526057|This was a multinational, randomized, double-blind, controlled trial in participants with active rheumatoid arthritis (RA) on a background of methotrexate (MTX). The study was conducted at 56 centres in 10 countries. There were a total of 220 participants enrolled in this study.|
734107|NCT01525927|2 participants enrolled, no data collected, no documentation of study intervention.|
734108|NCT01525875||
734109|NCT01525862||
734110|NCT01525849|Participants were screened, randomized, treated, and followed at 14 US centers from June 2011 to May 2014.|After screening, informed consent, and baseline measures, participants were randomized 1:1 to balloon sinus dilation or FESS. The assigned procedure was to be performed within 60 days of randomization.
734111|NCT01525745|all participants were enrolled in the RadOnc clinic at BIDMC|
734112|NCT01525667||
734113|NCT01525641|This is an Observational study. Patients in the study have received only the standard treatment and no investigational drug was adminstered.|
734114|NCT01525628|72 patients were treated and analysed.|This was randomised (Groups A and B only), controlled, open-label, parallel-group (Groups A to E), multi-centre trial in treatment-naive patients and patients with prior treatment relapse or partial responders with Genotype 1 (GT1) chronic Hepatitis C infection.
734115|NCT01525615||This was a randomised, placebo-controlled, double-blind, parallel-group comparison of once daily treatment with orally inhaled Tiotropium+Olodaterol Fixed Dose Combination (FDC) (2.5/5.0 µg; 5.0/5.0 µg) with placebo over 12 weeks.
734116|NCT01525602|A total of 74 participants (54 in Parts 1 and 2; 20 in Part 3) who met all inclusion and none of the exclusion criteria were enrolled in this study.|An open-label study. In Part 1 (dose escalation), participants were sequentially enrolled and received doses of PLX3397 600 to 1600 mg/day. In Part 2 (dose expansion), PLX3397 was administered at the recommended phase 2 dose with paclitaxel. In Part 3, PLX3397 was administered at 600 mg twice daily with paclitaxel; 2 participants were not dosed.
734117|NCT01525589|"The first patient was included on 27JUN12 and the first study treatment administration was on 28JUN12.
~The cutoff date for the results was 24OCT18. A total of 111 patients were included in the 3 cohorts of the study: 56 in Cohort A (BRCA+), 20 in Cohort A1 (BRCA+/PARPi), 35 in Cohort B (Unselected)."|
734118|NCT01525563||
734119|NCT01525550||"End of treatment for outcome measures of ECOG-PS, EORTC QLQ-C30 and EORTC QLQ-GI NET 21 was up to primary completion date (PCD) only."
734120|NCT01525420||
734121|NCT01525407||
734122|NCT01525329||
734123|NCT01525238||53 participants enrolled; 24 randomized; 24 treated with study drug. 29 participants were not randomized due to no longer meeting study criteria (25), withdrawal of consent (2), or other reasons (2).
734124|NCT01525225|Upon approval of Kombiglyze™ XR, the Food and Drug Administration (FDA) required the conduct of this clinical pharmacology study in pediatric patients as a post-marketing requirement (PMR). Study was initiated February 2013. On 14-Nov-13, the FDA issued a letter stating release from this PMR, thus the study was terminated prior to completion.|A total of 4 participants were enrolled. Two participants were treated and completed the study prior to the termination of the study.
734125|NCT01525173||
734126|NCT01525082||
734127|NCT01524991||
734128|NCT01524978||One participant with breast cancer was screened shortly after Cohort 5 (Breast Cancer) had been closed. This participant was allowed to enter the study in Cohort 7: Other BRAF V600-positive tumors. For analysis purposes Cohort 7 was split into sub-cohorts for indications with sufficient participants.
734129|NCT01524913|Participants were recruited from patients referred to the oral and maxillary surgery services at Emory University, the University of Pennsylvania, the University of California - Los Angeles, the University of Cincinnati, and the Oregon Health Science University. All patients were referred for management of temporomandibular joint (TMJ) pain.|A total of 105 patients were screened; three did not meet inclusion and exclusion criteria, resulting in 102 participants who were randomized and began the study treatment.
734130|NCT01524900|387 patients started treatment.|
734131|NCT01524887|Enrollment was conducted at 58 clinical sites worldwide.|Of 508 enrolled subjects, 303 met entry criteria. 42 subjects discontinued before randomization due to study termination. Of 261 randomized subjects, 10 subjects discontinued before receiving treatment (7 study termination, 2 withdrawal by subject, 1 withdrawal by caregiver). Number of subjects who received treatment (IVIG,10% or placebo) = 251.
734132|NCT01524796||
734133|NCT01524783|205 patients were randomized but only 203 patients received study drug. (Two patients randomized to everolimus were not treated due to withdrawal of consent and protocol deviation and one patient randomized to everolimus inadvertently received placebo treatment).|
734134|NCT01524770||
734135|NCT01524692||
734136|NCT01524679||
734137|NCT01524627|"Subjects were recruited from 1/2012-7/2015. Methods used to recruit were flyers, advertisements on public transportation, Craigslist, word of mouth.
~596 potential subjects were phone screened, 124 of those successfully consented, 43 were randomized"|
734138|NCT01524302||
734139|NCT01524289|This study was conducted at 26 study centers. Participants were to complete a 2-week placebo run-in period, a 52-week randomized treatment phase and a 12-week reversal phase (safety follow-up).|The study enrolled participants who were 18 to 80 years old, had a genotype-confirmed or clinical diagnosis of heterozygous familial hypercholesterolemia (HeFH), and had been treated with an optimal dose of statin for at least 6 weeks.
734140|NCT01524224||
734141|NCT01524198||
734142|NCT01524133||Patients were informed of assignment at first treatment visit. Only those randomized patients who started treatment are included below (16 patients never started treatment. They did not know condition assignment.).
734292|NCT01515072|The RIPNOD trial was conducted from July 2011 to July 2014 in two organ procurement organizations (OPO) in the U.S. Consent for research was obtained from donors next of kin by the OPO staff unless a 'first person' consent existed.|
734143|NCT01523964|Recruitment was from February 2012 to August 2013. Subjects know to the site staff were approached during clinic visits or by telephone to ascertain interest. In addition, referrals from message posted on DMD website were included if they met protocol criteria.|There were no significant events. Subjects were screened for eligibility and enrolled.
734144|NCT01523899||
734145|NCT01523886||
734146|NCT01523873|Patients scheduled for a Dotarem-enhanced MRI were recruited in 118 active centers in 10 countries from November 2008 to June 2013.|
734147|NCT01523834|"Date of first enrolment: 14th June 2011 Date of last completed: 3rd April 2017
~All patients (35) were enrolled in Italy."|
734148|NCT01523821|Patients signed IRB-approved consents during the period of 12/11/13 to 12/22/16. Treatment with alpha 1 anti-trypsin (AAT) typically started within 24 hours of consent. Patients were identified by clinical staff as needing additional treatment for acute graft versus his disease (GVHD) following initial therapy with corticosteroids.|
734149|NCT01523782||
734150|NCT01523756|The subjects were recruited through the Coloplast database.|
734151|NCT01523743||
734152|NCT01523613||
734153|NCT01523587|Open-Label Phase-III trial to compare the efficacy of afatinib with erlotinib for the second-line treatment of patients with advanced non-small cell lung cancer, who completed at least 4 cycles of platinum-based doublet chemotherapy. Randomization ratio was 1:1. Stratification was based on race.|Patients screened to ensure that they met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met. Tumor assessments at screening were completed within 21 days and other screening assessments were completed within 28 days, of randomization.
734154|NCT01523496||
734155|NCT01523457|Patients with pathologically confirmed, measurable or non-measurable assessable MPC or LAPC (including unresectable and borderline resectable) were recruited from November 2011 through January 2014.|
734156|NCT01523392|Patients recruited from 8 participating centers in the United States from 28 March 2012 until 04 September 2013|50 patients screened; 34 patients randomized; 30 patients completed the study (7, 8, or 9 days of both treatments), and 31 completed follow-up
734157|NCT01523366|Patients recruited from 6 centers in the United States from April 2012 until May 2013.|53 patients screened; 40 patients randomized; 38 patients completed the study (7, 8, or 9 days of both treatment sequences), and 39 completed follow-up.
734158|NCT01523301|This double-blind, randomized, multicenter, placebo-controlled, in-Patient study started recruiting in April 2012.|Participant flow refers to the Randomized Set (RS), consisting of all randomized subjects.
734159|NCT01523275|Recruited from the UCSF Voice and Swallowing Center clinic from August 1, 2012 to February 1, 2018|
734160|NCT01522976||
734161|NCT01522963||
734162|NCT01522950||
734163|NCT01522937||
734164|NCT01522924|The recruitment period began on February 23 and ended on April 19. The location of the study was at a dental school and the standardized patient clinic in the medical school.|Students were excluded from the study if they did not meet study requirements.
734165|NCT01522755|Recruitment period: 31 January 2010 - 24 January 2013. 32 implanting centers and 41 implanters participated in the study.|
734166|NCT01522703||
734167|NCT01522651|Participants were enrolled at study sites in Germany, Israel, Italy, Netherlands, Poland, and the United States. The first participant was screened on 24 January 2012. The last study visit occurred on 10 March 2014.|327 participants were screened.
734168|NCT01522456||
734169|NCT01522443|First patient enrolled: 15 March 2012, Data cut off date: 06 October 2014. The study was terminated by the Sponsor after 119 subjects were enrolled which was less than the planned sample size of 246 subjects.|
734170|NCT01522404|Participants were recruited between March 2012 and October 2017. The study is conducted at Emory University Hospital in Atlanta.|
734171|NCT01522391||
734172|NCT01522339|Patients, eligible to participate, were recruited from within the NICU beginning in February 2012 ending in April 2012.|All participants enrolled in the study, completed the study.
734173|NCT01522248||
734174|NCT01522235||
734175|NCT01522131||
734176|NCT01521949||
734177|NCT01521923|This study started to enroll subjects in January 2012.|Participant Flow refers to the Safety Set 2 (SS2) which consists of all subjects randomized into Period 1 who had received at least 1 dose of study medication (CZP/PBO) in Period 2. Of the 359 enrolled patients, 357 are included in the SS2.
734178|NCT01521897||
734179|NCT01521884||
734180|NCT01521871||
734181|NCT01521845||
734182|NCT01521780||
734183|NCT01521559|Participants with macular edema secondary to branch retinal vein occlusion (BRVO) involving the center of the macula in the study eye were eligible to participate in the study.|Of 281 participants who were screened for inclusion in the study, 183 were enrolled (started) and 183 received treatment.
734184|NCT01521546||Enrollment was required prior to assignment.
734185|NCT01521507|Between February 19, 2012 and October 15, 2012, this study enrolled subjects with meibomian gland dysfunction (MGD) and evaporative dry eye from nine ophthalmic practices in the United States.|A total of 274 subjects were consented and 200 subjects were randomized. Of the 74 subjects who were not randomized, 52 subjects did not meet the study eligibility criteria and 22 subjects elected not to participate prior to randomization or had not yet attended the Baseline visit when study enrollment was completed.
734186|NCT01521494||
734187|NCT01521364|"The study was performed at the Tuberculosis Centre Beatrixoord (University of Groningen, University Medical Center Groningen, Haren, The Netherlands).
~Dates of recruitment: from december 2011 to november 2012."|Not applicatble.
734188|NCT01521260|recruitment period: october 2009-september 2010 location: University Medical Center Groningen|Assessed for eligibility:55 patients Excluded 25, because 'not meeting inclusion criteria (n=20) or 'declined to participate' (n=5)
734189|NCT01521143|Different participants were enrolled in the 2 parts of the study.|
734293|NCT01515046||
734294|NCT01514864||A total of 19 patients were enrolled, and 14 received treatment in 2 cohorts: 9 with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation and 5 with NSCLC and a discoidin domain receptor 2 (DDR2) mutation.
734190|NCT01521026|Participants included 89 community-dwelling outpatients. Inclusion criteria were: primary psychotic disorder, age 18 or older, and fluency in English. Exclusion criteria were: dementia, neurological conditions affecting cognition, mental retardation, substance use disorder within the past month, and participation in other intervention trials.|Baseline data were collected before randomization.
734191|NCT01520987||
734192|NCT01520922||Participants (par.) who met eligibility criteria at Screening were then allocated to one of the following populations: par. with previously untreated CLL or par. with relapsed CLL. A total of 99 par. were enrolled and 97 par. entered the treatment period. Study results do not include the 2 par. that were not treated in this study
734193|NCT01520909|Pediatric participants meeting eligibility criteria were enrolled into 3 cohorts depending upon age. Cohort 1 enrolled participants who were between 12 and 17 years old, Cohort 2 enrolled participants who were between 6 and 11 years old, and Cohort 3 enrolled participants who were between 1 and 5 years old.|This study was comprised of a 13-week Double-Blind (DB), randomized Treatment Period (Part 1), followed by a 24-week Open-Label (OL) eltrombopag-only period (Part 2). After completion of Part 2, participants completed a 24- to 28-week Follow-up period, including an ophthalmic examination 24 weeks after the last dose of study treatment.
734194|NCT01520727||
734195|NCT01520714|Patients required at physician office. Recruiting will be active until 40 patients are randomized.|
734196|NCT01520688||
734197|NCT01520558||
734198|NCT01520532||
734199|NCT01520519|Recruitment Details: February 2012 - September 2012|
734200|NCT01520506||
734201|NCT01520454||
734202|NCT01520402|Thirty-five subjects responded to email and printed solicitations advertised at Mount Sinai Medical Center for the study, and five were excluded due to medication conflicts, unwillingness to take warfarin, and medical conditions precluding participation. Dates of recruitment spanned 04/2009 - 05/2012.|Subjects were educated regarding vitamin K restricted diet. Each maintained a food intake log and refrained from medications or alcohol for one week. Only subjects adhering to the prescribed diet and avoiding medications that could potentially interfere with warfarin metabolism qualified for the dose-response testing phase.
734203|NCT01520363||A total of 57 participants were consented. Of these 5 were slow metabolizers who did not meet post consent eligibility criteria.
734204|NCT01520324|This study recruited patients with a diagnosis of ulcerative colitis dating not less than 8 years.|This was an exploratory, non-comparative study with no randomization. All subjects were allocated to receive Selg 1000® 4 L bowel preparation, the day before colonoscopy. All study subjects were allocated to receive 200 mg of Methylene Blue MMX® tablets during and at the end of the intake of bowel cleansing preparation.
734205|NCT01520207|July 2012 - Jul 2016|
734206|NCT01520038||
734207|NCT01519960||A total of 211 individuals were screened for entry into the study. Of these, there were 161 participants enrolled in the study and included in the main analyses.
734208|NCT01519947||87 participants were enrolled in the study. One participant did not receive study drug.
734209|NCT01519934|Subjects who had received an Ulthera treatment to the face and upper neck at two treatment depths at one study site were recruited for study participation.|
734210|NCT01519921|A total of 150 participants were enrolled in this study conducted from 26 October 2005 to 24 June 2008 at 7 centers in Republic of Korea.|
734211|NCT01519882|The study started in March 2012 and was conducted in the United Kingdom. It was terminated due to recruitment issues in January 2013.|1 subjects was randomized to Placebo and started and completed the study (from Screening (Week 0) to the Safety Follow-Up Visit (Week 18)).
734212|NCT01519869||
734213|NCT01519817||
734214|NCT01519791|This study started to enroll subjects in January 2012.|A total of 880 subjects were randomized. Three subjects were randomized in error, were not dosed, and withdrawn shortly afterwards as screen failures. Two of them were included in the Randomized Set 1 (RS1) only and one of these three subjects was conservatively excluded from any output. Therefore, 879 subjects are in RS1.
734215|NCT01519778||
734216|NCT01519765||
734217|NCT01519713|Study participants were enrolled from 20 January through 25 February 2012 in 4 clinic sites in Japan.|A total of 200 subjects who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
734218|NCT01519700|The study population consisted of women of 18 years or older with histologically proven breast cancer who were eligible for neoadjuvant or adjuvant treatment with TAC chemotherapy. The study was aimed to randomize a total of 192 patients in approximately 65 centers worldwide.|The study started with a screening period of up to 21 days. During the screening period, the eligibility of the patients to participate in the study was assessed based on safety evaluations. After completion of the screening period, the patients were randomized to either EP2006 or US-licensed Neupogen® in four groups (see below).
734219|NCT01519674|"The trial was conducted at 60 sites in 10 countries as follows:
~Argentina (6); Australia (2); Brazil (4); Greece (5); India (17); Malaysia (3); Portugal (6); Republic of Korea (7); Thailand (5); Turkey (5)"|Subjects on pre-trial metformin (1000 mg/day) (± additional OAD treatment) continued their medication. Subjects on pre-trial sitagliptin (100 mg/day) either continued or discontinued their sitagliptin treatment depending on the treatment group the subjects were randomised to.
734220|NCT01519661||
734221|NCT01519648||
734222|NCT01519635|47 patients were screened in a single centre (service of Nephrology, CHUV, Lausanne)|24 patients were enrolled but 4 were excluded because of the lack of adequate venous access or for other reasons.
734223|NCT01519570||
734224|NCT01519518||
734225|NCT01519466||A total of 55 subjects consented and enrolled into the study. Six of these withdrew before randomisation or failed screening. Forty-nine (49) subjects were randomised and completed the study.
734226|NCT01519427|Subjects were recruited from January 2012 through February 2013.|Four potential subjects consented. Two were ineligible.
734227|NCT01519414||
734228|NCT01519323|First investigational site was activated on 22 December 2011.|Participants were enrolled in two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. Participants >=45 kg were then enrolled in a dose escalation period. No participants were enrolled in the <45 kg cohort.
734229|NCT01519284||
734230|NCT01519271|Potential participants were a convenience sample of PD patients primarily from the Parkinson's Disease and Movement Disorders Center at the University of Pennsylvania. Patients between the ages of 40 and 85 y with idiopathic PD for more than 2 years and reporting cognitive were screened for study participation.|48 participants assessed for eligibility, 28 randomized (17 did not meet inclusion/exclusion criteria and 3 refused to participate after screening)
734231|NCT01519245|All patients scheduled to undergo elective or urgent CABG at Royal University Hospital between December 1, 2011 and April 30, 2012 were screened for participation. Patients meeting inclusion criteria were approached by a study team member at the time of pre-admission clinic attendance or on the in-patient ward with an invitation to participate.|Patients meeting inclusion criteria were eligible for study participation. Randomization of consented participants took place by the Clinical Trials Pharmacy on the day of surgery, following confirmation of surgical procedure. The study team could withdraw consented patients prior to randomization and surgery if exclusion criteria were identified.
734232|NCT01519206|Thirty-five (35) subjects were enrolled, 3 were deemed screen failures. Thirty-two (32) received study treatment. The first subject was treated on August 3, 2011 and the last subject was treated on 11/28/2011. The last patient follow-up for the trial was 11/21/2012.|
734233|NCT01519167||The number of subjects enrolled was 91, of that 90 subjects received study drug. The remaining 1 subject not treated due to subject being a screen failure.
734234|NCT01519089||
734235|NCT01519063||The number of participants enrolled was 75. However, 19 people did not start medication due to ineligibility or drop out, leaving 56 total participants.
734236|NCT01518972|Participant were recruited from September 2009 to June 2012 (2 years and 9 months). Out of 354 people who inquired about the study, 30 were eligible and randomized.|Out of 354 individuals who inquired about the study, 54 consented and completed the in-person screen. Out of these 54 individuals, 2 declined participation and 22 were ineligible: 10 individuals did not have PTSD and the rest had an acute illness (4), uncontrolled psychosis (2), legal involvement (2), and other reasons not previously mentioned (4).
734237|NCT01518946||
734238|NCT01518868|A total of 126 participants (252 eyes) were enrolled. One-half of the participants were randomized to receive the investigational contact lens during the first crossover period, and the other half were randomized to receive the PureVision contact lens during the first crossover period. The participants crossed over to the other group at 1 week.|
734239|NCT01518530|From January 2012 to February 2012 twenty-three patients were screened and 10 were found to be eligible in the Physical Therapy Department of the Hillel Yaffe Medical Center.|One recruited patient was dropped because of protocol violation.
734240|NCT01518374|All enrolled subjects who received an injection of florbetapir and completed safety assessment were considered to have completed the study.|This was a standardized imaging protocol designed to support companion studies where amyloid imaging was used as a biomarker in longitudinal studies of aging or studies of biomarkers for neurodegenerative diseases. Subjects had to meet additional inclusion/exclusion criteria for the companion protocol before being injected and imaged under A14.
734241|NCT01518322|The study was conducted at 5 primary care clinics in the US. First Subject Enrolled: 01Nov2011. Last Subject Completed 16Feb2012.|Following completion of the screening questionnaire that collected information about self-reported non-specific lower respiratory complaints such as cough, wheeze or shortness of breath, eligible subjects were invited to participate in the study.
734242|NCT01518309|This was an open-label extension study, including patients with idiopathic Parkinson's Disease (PD) who had completed study ACP-103-006 (PD psychosis [PDP]) or study ACP-103-004 (PD with dyskinesias) and would benefit from continued pimavanserin treatment, as judged by the investigator.|
734243|NCT01518270||
734244|NCT01518257||
734245|NCT01518244|Participants were recruited from 6 study centers located in South America: Argentina (3), Chile (1), and Mexico (2).|This reporting group includes all participants who received at least one dose of AZARGA®.
734246|NCT01518192|Adult patients with typical erythema migrans, examined in the period from June to September 2006 at Lyme Disease Outpatient Clinic, University Medical Center Ljubljana, Slovenia|"113/398 patients were ineligible due to:
~receiving antibiotic with known anti-borrelial activity (73)
~multiple erythema migrans (16)
~history of Lyme disease (12)
~immunocompromising condition (4)
~serious adverse reaction to study drugs (3)
~pregnancy or lactation (4)
~erythema migrans accompanied by meningitis (1)"
734247|NCT01518153|Recruitment Period: February 6, 2012 to February 27, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned Donor Lymphocyte Infusion (DLI). 9 participants did not meet the criteria to receive randomized planned DLI.
734248|NCT01517984||
734249|NCT01517893||
734250|NCT01517867||
734251|NCT01517763||This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.
734252|NCT01517750||
734253|NCT01517659||
734254|NCT01517529|We plan to enroll 10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin (RBV) therapy (NR) and are therefore eligible for combined treatment with PI therapy according to the recent FDA approvals for Boceprevir. Patients will be recruited from the outpatient clinics at the University of Cincinnati College of Medicine|
734255|NCT01517412|The study was conducted at 82 centers in 10 countries. A total of 734 participants were screened between February 15, 2012 and October 16, 2012. 283 participants were screen failures; main reason for screen failure was that glycosylated hemoglobin (HbA1c) values were out of protocol defined range. 451 participants were randomized.|Participants were stratified according to main meal of day (breakfast, lunch or dinner) and screening values of HbA1c (<8% or ≥8%).
734256|NCT01517373||A total of 628 participants were consented. Of these, 361 participants transitioned to the run-in period and received sponsor provided background therapy of Metformin. Participants completed the run-in period were then randomized to receive either placebo, PF-04937319 (10, 50 or 100 milligram [mg]) or Glimepiride in treatment period.
734257|NCT01517295||
734295|NCT01514786||
734296|NCT01514760||
734297|NCT01514734||
758024|NCT00178126||
734258|NCT01517282|Subjects were recruited and screened between 2 January 2012 and 22 July 2013 at 5 trial centers in Europe (1 in Germany, 2 in Poland, and 2 in the United Kingdom). Screening could occur between 10 and 35 days prior to dosing on day 1. Subject eligibility was determined at the screening visit and confirmed before the first dose on day 1.|
734259|NCT01517178||A total of 33 subjects were enrolled in the trial. Of these, 6 discontinued during the New ostomy base plate run-in period prior to period 1 and were excluded from the Intention-To-Treat analysis set (no performance data obtained). 27 subjects comprised the intention-to-treat population.
734260|NCT01517074||
734261|NCT01516970||
734262|NCT01516957|A total of 168 subjects were enrolled in the double-blind phase of the study. Of these 168 subjects, 156 entered the open-label extension phase (52 subjects were previously dosed with placebo, 53 subjects with brodalumab 140 mg Q2W, and 51 subjects with brodalumab 280 mg Q2W).|
734263|NCT01516892||
734264|NCT01516879|Adults with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 75 mg/dL and triglycerides ≤ 400 mg/dL were eligible. The first patient enrolled on 5 January 2012 and the last patient enrolled on 12 October 2012. All patients were counseled on the National Cholesterol Education Program Adult Treatment Panel III Therapeutic Lifestyle Changes diet.|Patients were assigned to 1 of 4 background lipid-lowering regimens for a 4-12 week stabilization period: diet alone, diet and 10 mg atorvastatin daily, diet and 80 mg atorvastatin daily, or diet, 80 mg atorvastatin and 10 mg ezetimibe daily. Patients meeting criteria were randomized 2:1 to evolocumab or placebo, stratified by background therapy.
734265|NCT01516749|Patients were recruited from an academic dermatology practice in San Francisco, CA; informed consent was obtained before study entry.|11 patients were screened for inclusion. 6 were eligible and were enrolled.
734266|NCT01516736||
734267|NCT01516684|"Originally 33 participants were registered, with 170 trials; each participant had between 1-14 trials (median=4).
~Five of these participants did not end up receiving the procedure and 1 was a screen fail, leaving 27 participants with between 1-14 trials (median=5)."|
734268|NCT01516632|Participants were recruited nationally through online advertisements (e.g. Craigslist) between May 3, 2011 and August 4, 2011. Smokers expressed their interest by completing an online screener form, which was then e-mailed to the project coordinator.|Of the 1,916 people who expressed interest, 585 (31%) were eligible for the study. Of these 585, contact was not made with 49% (n = 284). Fifteen percent (n=90) declined to participate. 211 eligible participants consented to participate and were randomized into the study. 47 terminated after randomization (i.e. did not complete enrollment process)
734269|NCT01516437||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. 3 enrolled subjects did not receive subject allocations, and were excluded from the study prior to start.
734270|NCT01516424||
734271|NCT01516268|recruitment period: Jan 2012- Dec 2013 Shariati hospital, a tertiary center|Exclusions were based on exclusion criteria previously mentioned.
734272|NCT01516034|Recruitment period: 20-Nov-2011 to 11-Mar-12 Location: Dermatological clinic|
734273|NCT01516008|The study was conducted from 11 January 2012 to 2 February 2013. Participants were recruited at 17 study centers in Korea.|353 participants were randomly allocated to the 3 treatment arms. 352 participants received at least 1 dose of the study drug and were included in the intent-to-treat (ITT) analysis set.
734274|NCT01515995||
734275|NCT01515956||
734276|NCT01515943||
734277|NCT01515891||
734278|NCT01515865||Subjects received the dose and frequency of Midodrine HCl that they had been receiving during their non-study treatment prior to enrolling in this study.
734279|NCT01515748|The study was conducted at 19 sites in Korea. A total of 693 participants were screened between 30 December 2011 to 02 January 2019, of which, 163 were screen failures. Screen failures were mainly due to inclusion criteria not met.|Total of 530 participants were enrolled and randomized in study. Assignment was done using Interactive Web-Response System (IWRS) in 1:1 to treatment arms. Randomization was stratified by site and Tumor size, Lymph Nodes affected, Metastases (TNM) [T2/N+,T3-4/N+,T4/N-] stage. Results are reported based on primary completion date of 21 January 2019.
734280|NCT01515696|3 year study period 789 infants were eligible for enrollment in the study|Six hundred ninety-three infants were excluded for the following reasons: informed consent was not obtained in time(n = 660), parental refusal (n = 21), and 12 infants died before randomization.
734281|NCT01515657||
734282|NCT01515566|Outpatient participants from the Supportive Care Center at MD Anderson Cancer Center were recruited between July 10, 2012 and December 12, 2012.|Six participants of the 26 recruited were excluded from the trial before assignment to groups due to ineligibility.
734283|NCT01515540|38 patients were recruited for the brain imaging and treatment study. Data from 7 subjects was not analyzed due to failure to attend the repeat sessions for non specific reasons and data from 1 subject was excluded from analysis due to technical faults. Thus, data from a total of 30 subjects was included in the brain imaging analysis.|
734284|NCT01515488|Patients were recruited from the Pediatric Emergency Department at Maricopa Integrated Health System between February 2012 and April 2012.|
734285|NCT01515475||
734286|NCT01515423||1429 participants received at least 1 dose of the study agent in the Open-label Phase, out of which 1016 participants were randomized into the Double blind Phase (Safety population).
734287|NCT01515410||A total of 34 subjects were randomly assigned to treatment in this crossover study: 19 in the DM-1992 for Period 1 and Sinemet IR for Period 2 sequence, and 15 in the Sinemet IR for Period 1 and DM-1992 for Period 2 sequence. All 34 subjects received study treatment and were included in the safety and intent-to-treat (ITT) populations.
734288|NCT01515345|all consecutive PCI patients with stent implantation or drug eluting balloon dilation in our institution until June 2012|
734289|NCT01515306||
734290|NCT01515189||831 participants were enrolled; 727 were randomized to a treatment group; 726 received at least one dose of study treatment. Of the 105 participants not treated, 81 no longer met study criteria, 11 withdrew consent, 4 suffered an Adverse Event, 4 died, and 5 were not treated due to investigator decision or other reasons.
734291|NCT01515176||
734477|NCT01500772||
734478|NCT01500759||
758962|NCT00096135||
734298|NCT01514682||Signed a consent form: 52 (50 unique subjects: 2 withdrew then later re-enrolled, not counted in analysis); Ineligible prior to Evaluation Phase: 1 subject (1=clinically unstable); Entered Evaluation Phase: 49 subjects; Withdrawn prior to randomization: 10 (8=Did not meet BPRS criteria; 1=Did not meet age criteria; 1=On an excluded medication)
734299|NCT01514630||
734300|NCT01514513||
734301|NCT01514461||
734302|NCT01514448||Single arm study of everolimus broken down into 2 subgroups for analyses and safety based on failed 1st line therapy (sunitinib or pazopanib) prior to starting study.
734303|NCT01514422|Study procedures were conducted between June 2011 and June 2013 at the Mood and Anxiety Disorders Program at Icahn School of Medicine at Mount Sinai.|
734304|NCT01514396||
734305|NCT01514383||
734306|NCT01514370||Subjects who had been receiving treatment with subcutaneous interferon (IFN) beta 1a 44 microgram (mcg) three times a week (TIW) for a minimum of 6 months and for not longer than 24 months before enrollment, were enrolled in this study.
734307|NCT01514357|Subjects were recruited at Mayo Clinic in Rochester, Minnesota.|
734308|NCT01514318|The site had a list of patients to call based on previous enrollment into an IDE study from back in 1998. There was not additional recruitment required.|Assignment was based on subjects signing the consent form. They were either in the study or not.
734309|NCT01514292||
734310|NCT01514279|Participants were recruited between May 2012 and January 2014 as part of an existing BMI and blood pressure screening program in the local school district. Participants were randomly assigned to 1 of 3 intervention study arms within 37 days of the baseline clinical visit once recruited.|
734311|NCT01514240|First patient enrolled on 08 February 2012. Last subject last visit on 08 September 2014.|Out of 123 enrolled subjects, 112 subjects were randomised and 11 subjects were not randomised. The reasons of no randomisation were 'Eligibility criteria not met' (9 subjects) and 'Adverse event' (2 subjects).
734312|NCT01514201|Patients up to 21 years of age with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs) were enrolled at Pediatric Brain Tumor Consortium (PBTC) member institutions. The first patient was enrolled on 2/1/2012 and the last patient was enrolled on 01/20/2016.|Of the 66 patients enrolled, 1 phase II patient was deemed ineligible due to an elevated alanine aminotransferase (ALT). Of note, the 6 phase I patients who were treated at the established maximum tolerated dose (MTD) during the phase I portion of the trial were also counted as phase II patients in analyses of phase II objectives.
734313|NCT01514162||
734314|NCT01514149||
734315|NCT01514136|The subject were recruited through the Coloplast A/S user database in Denmark.|The investigation consisted of two periods: in the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts, Test A*-D*, were developed and tested. The test products were not randomised. The test order in first round was Test A - Test D and in second round it was Test A*-Test D*.
734316|NCT01513967||
734317|NCT01513902||Participants aged 2 to less than (<)18 years with juvenile idiopathic arthritis (JIA) were enrolled in the study.
734318|NCT01513759||
734319|NCT01513590|The trial was conducted at 47 sites in 10 countries: Algeria (4), Bulgaria (7), Croatia (5), Czech Republic (4), Germany (5), Poland (5), Romania (5), Slovakia (3), Turkey (2), and Ukraine (7).|Subjects continued their metformin monotherapy or metformin in any combination with one of the following OADs: insulin secretagogue (sulphonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, α-glucosidase inhibitors for at least 12 weeks prior to randomisation.
734320|NCT01513551|This trial was conducted at 25 trial centers: 10 in the United States; 2 in Canada; 2 in Denmark; 2 in Israel; 2 in Norway, 3 in Poland, 2 in Spain and 2 in Sweden.|
734321|NCT01513538||
734322|NCT01513473|"The trial was conducted at 72 sites in 12 countries as follows:
~Bulgaria (2), Finland (5), France (4), Germany (3), Italy (2), Japan (15), Netherlands (5), Republic of Macedonia (2), Russian Federation (6), South Africa (2), United Kingdom (4), United States (22)"|
734323|NCT01513460||
734324|NCT01513447|Recruitment began 4/17/2012, ended 10/26/2012. Recruitment stopped due to low number of subjects meeting study criteria for entry.|Delivery of infant in less than 90 minutes from recruitment.
734325|NCT01513330|The subjects were recruited via sites and user data-bases in Denmark, Norway, Germany and France.|
734326|NCT01513317|76 participants were enrolled at 6 sites in Spain, 5 sites in the United States, 4 sites in Belgium, 3 sites each in Australia and the Russian Federation, 2 sites in the Netherlands, and 1 site in Sweden.|All 76 participants were enrolled and randomly assigned in the study.
734327|NCT01513291||A total of 423 participants were screened. Of these, 237 participants completed screening and met the eligibility criteria, including the required number of migraine days during the Screening period.
734328|NCT01513239|Male and female participants 18 years of age or older, diagnosed with Clostridium difficile infection (CDI) and receiving Standard of Care (SOC) therapy were recruited for this trial.|
734329|NCT01513148||
734330|NCT01513122||
734331|NCT01512979||
734332|NCT01512849||
734333|NCT01512797|Recruitment for this study took place from July 2012-July 2016. Recruitment and data collection for this study was started at St. Luke's Hospital in New York, NY and later moved to Columbia University Medical Center in New York, NY.|37 participants were enrolled, however only 32 participated in study procedures and demographic information collection.
734334|NCT01512758|Participants took part in the study at 8 investigative sites in Singapore, Taiwan, Hong Kong, and South Korea from 06 February 2012 to 08 October 2013.|Participants with a diagnosis of advanced solid tumors or lymphomas received alisertib 30 mg or 40 mg twice a day (BID) for 7 consecutive days followed by a 14-day rest period in 21-day cycles (28-day cycles with additional 7-day rest period if all alisertib-related toxicities [except alopecia] were not resolved to less than Grade 2).
734335|NCT01512745||
734336|NCT01512693||
734337|NCT01512667||
734338|NCT01512446|The study was early terminated due to a low recruitment rate|
734479|NCT01500746|Recruitment dates extended from december 2011 to October 2013.|
734480|NCT01500733||
734481|NCT01500720||A total of 232 participants were screened of which 53 were screen failure and 179 were randomized.
734339|NCT01512368|From March 2010 to August 2011 a total of 60 sedentary young women without contraindication for exercising were included. Study was carried out at Department of Endocrinology, Cardiology and Internal Medicine of the INCMNSZ.|In the initial visit, patients were instructed to keep unaltered their diet, lifestyle and physical activity. Basal daily physical activity was evaluated with a questionnaire. All participants were assigned to the intervention group. All subjects underwent basal and final physical and biochemical evaluation.
734340|NCT01512264||
734341|NCT01512251||
734342|NCT01512225|Recruitment took place from June 1, 2012 to June 30, 2015 in 8 Neonatal Intensive Care Units in Canada|Mothers could be identified in the NICU as early as day 4 until day 18 post-delivery. Additional counseling and support by the lactation consultant with respect to non-pharmacologic techniques were offered. If there was no response to the techniques, the mother was considered eligible for the trial.
734343|NCT01512160||
734344|NCT01512108|The trial was conducted at 36 sites in Japan.|
734345|NCT01511978|Participants were referred by active Investigational New Drug (IND) holders involved with the Jacobus Pharmaceutical Company's 3,4-diaminopyridine (3,4-DAP) free base compassionate distribution program.|52 patients were assessed for eligibility. 20 were ineligible. 32 were randomized and completed the study.
734346|NCT01511939||
734347|NCT01511809||
734348|NCT01511536|Participants were enrolled at 2 centers in phase 1 part and 3 centers in phase 2 part between March 2012 and April 2014.|Phase I was a dose escalation part of Cabazitaxel, administered with a constant dose of abiraterone, to determine maximally tolerated dose. Phase 2 was efficacy and safety evaluation of Cabazitaxel at a dose, determined in Phase 1, in combination with abiraterone.
734349|NCT01511445|The study was designed as double-blind randomized trial. The design called for randomizing 100 patients.|Four additional patients were randomized when four patients were excluded for protocol violations prior to the primary endpoint. A surgeon who had not been trained as an investigator operated on these four patients, making numerous protocol violations in implant technique. These patients were randomized and had pre-op data in the study.
734350|NCT01511419||
734351|NCT01511315||
734352|NCT01511250|Participants took part in the study at 8 investigative sites in Puerto Rico, Colombia, Singapore and Thailand from 16 November 2011 to 15 April 2016.|Healthy participants were enrolled in the 2-part study to receive 0.5 mL tetravalent dengue vaccine (TDV) or placebo in 1 of 4 groups for Part I: 21-45 years, 12-20 years, 6-11 years, 1.5-5 years, and in 1 group for Part II: 1.5-11 years. Part II started after all subjects in Part 1 were enrolled.
734353|NCT01511107||
734354|NCT01511081|Recruitment Period: August 28, 2012 to August 31, 2015. Recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 21 participants enrolled, four were excluded from the study before assignment to groups.
734355|NCT01511068||
734356|NCT01511055||
734357|NCT01511016|HIV-positive subjects meeting the entry criteria were recruited from March, 2003 until November, 2010 from the clinics of Harris County Hospital District, and Legacy Community Health Center, Houston.|If a potential study subject was already taking a lipid lowering medication at the time of screening but was otherwise eligible for the study, he/she was invited to stop the medication for 6 weeks, at the end of which the fasting triglyceride level was re-measured to gauge eligibility.
734358|NCT01510912||
734359|NCT01510834|Participants were recruited from July 22, 2011-November 30, 2011. Recruitment was accomplished through targeted mailings to VA patients at risk for PTSD; study flyers at VA mental health providers; and social media networks to target veterans. Pre-screening, consenting, assessments, enrollment, and intervention were done completely online.|To minimize participant risk, secondary screening excluded veterans who did not meet risk criteria for mild to moderate PTSD (score <25 or >73 on the PCL-M), or had severe depression (scoring ≥20 on the PHQ-8). 354 veterans registered on the site, 95 did not complete screening; 169 screened out; 90 completed baseline assessments.
734360|NCT01510769||330 participants were randomized and 324 participants were included in the Intent-to-Treat (ITT) population (ie, 6 subjects were randomized but not treated).
734361|NCT01510756||
734362|NCT01510717|Participants were recruited and enrolled from 15 investigative sites located in the United States.|Of the 409 participants enrolled, 80 were discontinued prior to randomization as screen failures and 9 were discontinued after randomization prior to implantation. This reporting group includes all participants with successful IOL implantation in at least 1 eye (320).
734363|NCT01510704||
734364|NCT01510652||"1078 patients have been enrolled in this study, while 1074 have been randomized to Quad or BiP group.
~The randomization procedure happened after the enrollment and before the implant, this explains why not all 1078 patients have been randomized"
734365|NCT01510457||
734366|NCT01510379|Recruitment occurred at The Ohio State University Wexner Medical Center over a 1 year period.|Enrolled participants were not excluded from the trial before assignment to groups.
734367|NCT01510327|From October 9, 2009 to February 9, 2010 there were 11 patients enrolled at 2 investigative sites in the United States and 11 patients enrolled at 3 sites in Japan. All enrolled patients received a PROMUS Element study stent.|
734368|NCT01510158||
734369|NCT01510145|Patients were recruited from 4 study centers located in Argentina, 4 study centers located in Chile, and 2 study centers located in Colombia.|This reporting group includes all enrolled patients (191).
734370|NCT01510028|The study was conducted at 5 main sites for cohorts 1 to 3 in Brazil, Denmark, Germany, France, and Australia and 3 main sites for cohort 4 in Denmark, France, and Germany between 02 February 2012 (first participant first visit) and 20 January 2017 (last participant last visit).|A total of 34 participants were screened and 24 participants were enrolled in the study. Out of which 23 participants completed the study.
734371|NCT01509950|Recruitment into the first two arms (Staples and Prolene non-absorbable sutures) occurred through May 2013. The study protocol was modified in July 2014 and the third arm of the study, absorbable sutures, was added, however, no recruitment occurred after this modification.|
734372|NCT01509872||
734373|NCT01509807||
734374|NCT01509677||
734375|NCT01509664|Participants were recruited via advertisement|
740141|NCT01168232|The study was activated on 9/7/2010 and closed to accrual on 8/26/2013 (suspended from 3/5/2012 to 9/30/2012).|
734376|NCT01509638||23 patients in Group 1 and 25 patients in Group 2 were enrolled. 22 patients from Group 1 and 23 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
734377|NCT01509625||
734378|NCT01509612|Patients were recruited from February 2012 to July 2017|Screened participants were excluded from participation in the study when mutations had been observed, these were treated as screening failures and not included in the trial (= not randomized, n=8).
734379|NCT01509586||
734380|NCT01509547||
734381|NCT01509404||
734382|NCT01509183|Participants were recruited between April 2012 & June 2013 via an asthma registry, community outreach efforts, and provider referrals.|
734383|NCT01509105||
734384|NCT01509079||
734385|NCT01509053||This study included a Tolerability Assessment Phase A (if applicable), an Open-Label Aripiprazole IM Depot Phase B and an Open-Label Aripiprazole IM Depot Extension Phase C.
734386|NCT01509040||
734387|NCT01508936|A total of 869 patients were screened for enrollment into this study. Of the 869 patients screened, 511 patients at 103 centers in the US met entry criteria and were considered to be eligible for enrollment into the study.|Randomization was stratified by occurrence of asthma exacerbation(s) during the previous year (yes or no). Within each stratum, patients were randomly assigned in a 4:1 ratio to receive treatment with reslizumab at 3.0 mg/kg or matching placebo.
734388|NCT01508910|The study started in May 2012 and completed in November 2015.|"291 participants provided informed consent and were screened. There were 179 screen failures. 112 participants were randomized and treated. Note that during treatment the number of arms increased from 3 to 4 to include Not Injected arm as 6 participants in Treatment and Active Control Arms did not have intramyocardial injections."
734389|NCT01508832|Volunteers recruited through local media source. Protocol consisted of a single study day in anesthesia research study space at the University of California San Francisco Parnassus campus.|
734390|NCT01508702||
734391|NCT01508676||
734392|NCT01508650||
734393|NCT01508455|Neonatal subjects enrolled from 3 centers in the United States|
734394|NCT01508325||
734395|NCT01508169|From April 2011 to October 2011, patients in treatment in the outpatient clinic of the Rheumatology Division of Unicamp, who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assessed.|From the 242 patients considered eligible, 148 were not included due exclusing criteria (compromised skin integrity of the lower limbs, autoimmune rheumatic diseases, vestibular symptoms, central nervous system pathologies, peripheral neuropathy, use of insoles in the last month, previous foot surgery, inability to attend the reevaluations).
734396|NCT01508130|A total of 672 participants were enrolled at 64 study sites in the U.S between 20 January 2012 and 8 February 2013.|Out of 672 participants, one was not eligible to receive triple therapy (pegylated interferon alfa [PegIFN], ribavirin [RBV], and telaprevir or boceprevir) and 17 who received only dual therapy (PegIFN + RBV) were excluded from all analyses. A total of 635 participants were included in modified all treated (mTRT) population.
734397|NCT01508117|Recruitment period 8/10/11-10/26/12|
734398|NCT01508052||
734399|NCT01508013||
734400|NCT01507896|Enrollment was conducted at 10 clinical sites in 8 countries (Bulgaria, Czech Republic, Poland, Romania, Russia, Ukraine, Chile, Colombia).|30 unique participants enrolled for 41 surgical procedures, of which 1 participant discontinued before treatment with BAX326 but re-enrolled later for another surgical procedure. Note: a unique participant can undergo more than one surgical procedure.
734401|NCT01507831|The study was conducted at 320 centers in 27 countries. Overall, 5144 participants were screened between January 2012 and March 2013, 2801 of whom were screen failures. Screen failures were mainly due to exclusion criteria met. In addition 2 participants received study drug but did not undergo randomization. They were excluded from analysis.|Randomization was stratified as per diagnosis of heterozygous familial hypercholesterolemia (heFH), prior history of myocardial infarction (MI) or ischemic stroke, intensity of statin treatment and geographic region. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:2 ratio (placebo:alirocumab).
734402|NCT01507779||
734403|NCT01507688|Recruitment period ran from Jan 7, 2013 through March 31, 2016. Recruitment sites included 2 Veterans Health Administration Medical Facilities, 1 Joint Commission Stroke Center in an urban Hospital, and 1 Safety Net Urban Hospital.|
734404|NCT01507662|Patients presenting for DXA centers were recruited through February 2012 to August 2014 at three health centers-the University of Iowa (UI), the University of Alabama at Birmingham (UAB), and Kaiser Permanente of Georgia (KPGA).|
734405|NCT01507584||The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report.
734406|NCT01507493||
734407|NCT01507350||
734408|NCT01507298||
734409|NCT01507246|Dates of recruitment Dec 13, 2011 to July 3, 2012|open-label, sequential study with two treatment groups. Patients were to be excluded if they met certain intraoperative exclusion criteria.
734410|NCT01507233||
734411|NCT01507220||
734412|NCT01507181|Participants were recruited through the inpatient psychiatric service or through an academic outpatient psychiatric clinic. All study treatments were performed at Mount Sinai Hospital between April 2012 and June 2014.|
734413|NCT01507155||
734414|NCT01507103|First/last participant (informed consent): Feb 2012/Dec 2013. Study completion date: Jun 2014.|Enrolled: 140 screened for eligibility; 16 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria), 124 subjects randomized.
734415|NCT01507090|Enrollment from clinics, inpatient wards and referrals.|
734482|NCT01500694|The study was conducted at 52 sites in 11 countries in Europe: Austria, Belgium, France, Germany, Italy, The Netherlands, Poland, Romania, Spain, Ukraine, and United Kingdom.|Overall 218 participants screened, of them 215 were enrolled and 214 were treated in the study.The first participant's consent was obtained on 20 March 2012 and last participant assessment took place on 15 September 2015.
734483|NCT01500629||
734416|NCT01507051|Participants were recruited by 2 centers in Germany: ClinPharmCologne - MEDA Manufacturing GmbH, Neurather Ring 1, 51063 Koeln, and CRS Clinical-Research-Services Moenchengladbach GmbH, Hindenburgstrasse 304-306, 41061 Moenchengladbach. 84 participants were planned to participate (n=28 per group; minimum completion target n=75, n=25 per group).|488 participants were screened, 392 were dropped. 96 participants were included in the study, 55 by Trial Unit 1 ClinPharmCologne, and 41 by Trial Unit 2 CRS Moenchengladbach. 91 participants were included in the safety set, 84 participants were valid for the assessment of pharmacokinetics and pharmacodynamics (PK/PD set).
734417|NCT01506960||
734418|NCT01506947|This study was conducted at 7 centers in Turkey.|
734419|NCT01506908|Participants were recruited at the clinical site.|Of 423 screened participants, 323 were randomized while 94 did not meet the study criterion and remaining 6 discontinued due to other reasons. All randomized participants had a history of smoking more than 20 cigarettes per day.
734420|NCT01506882|This multicenter study started to enroll subjects in December 2011 in order to end up with 27 centers with enrolled subjects in Japan.|Participant Flow refers to the Randomized Set (RS). RS consists of all subjects who were randomized to the study groups.
734421|NCT01506726||
734422|NCT01506596||
734423|NCT01506479|Prescreening by telephone and for patients in movement disorder clinics from May 2012 to November 2015.|Screening included confirmation of Parkinson disease diagnosis, assessment of depression and cognition, testing for laboratory measures, and testing for blood pressure and echocardiogram responses to exercise during graded exercise. Once deemed eligible, baseline assessments were completed for disease and non-disease specific scales.
734424|NCT01506453|51 participants were enrolled and screened between January 2012 and October 2016.|The remaining 51 participants were randomized to take gabapentin or placebo.
734425|NCT01506362||
734426|NCT01506323|Veterans with a history of military-related posttraumatic stress disorder (PTSD) were recruited from January 2012 to March 2014 from outpatient clinics and primary care providers at the VA San Diego Healthcare System in San Diego, CA, and the Edith Nourse Rogers Memorial VA Hospital in Bedford, MA.|"Five (5) enrolled participants were excluded from the trial before assignment to groups due to:
~1) lost to follow-up; 2) could not commit to the study; 3) transportation difficulties. Three (3) participants were missing significant demographic data, resulting in a total of 173 for the analysis."
734427|NCT01506271|Adults 18 years or older with complicated intra-abdominal infection (cIAI) requiring treatment with intravenous (IV) antibiotic therapy were enrolled in this study.|
734428|NCT01506193||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
734429|NCT01505933||1 participant was excluded prior to assignment group
734430|NCT01505881||
734431|NCT01505764|10 subjects were consented, 9 received drug or placebo, 5 completed the study.|
734432|NCT01505673||
734433|NCT01505647||One participant in the ZOSTAVAX™ (AMP) group was randomized but not vaccinated, making the number of participants vaccinated in this group 331
734434|NCT01505634|Participants were enrolled with complicated urinary tract infection (cUTI) or acute pyelonephritis judged by the investigator to be serious (requiring hospitalization and intravenous (IV) antibiotic therapy); pyuria; and 1 positive urine culture within 48 hours of enrollment.|
734435|NCT01505608||Phase 1- All patients assigned to TPI 287 group. Randomization began in Phase 2- Arm A patients were allowed to cross over to Arm B during cycles 1-6 if they experienced progression. 0 (zero) Arm A patients crossed over to Arm B on this study.
734436|NCT01505530||"The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have completed the trial if they died due to any cause while on study or completed treatment and was known to be alive at the last scheduled follow-up."
734437|NCT01505491|This was phase I, open-label, randomised, parallel-arm, single-dose, active -comparator study with healthy subjects.|Subjects were screened for eligibility to participate in the trial. They attended a specialist sites which ensured strict implementation of inclusion/exclusion criteria and they were not to be entered in trial if any one of the specific entry criteria was violated. They were free to withdraw their consent at any time without penalty or prejudice.
734438|NCT01505465||
734439|NCT01505387|Trial conducted from January 2012 to September 2012 in two study sites in Germany|
734440|NCT01505374|Recruitment was from the period of 4/16/12-9/4/13 at the Hospital for Special Surgery. Patients were identified on the day of surgery and randomized prior to the start of surgery.|Patients were excluded prior to randomization if they had contraindications to spinal or epidural anesthesia, had chronic opioid use, pre-existing neuropathies in the limbs, allergies to pre-operative medications, contraindication to assigned nerve blocks, allergy to local anesthetic, American Society of Anesthesia 4-5, and non-English speaking.
734441|NCT01505179|Between 12/2011 and 3/2013, the UCSD Echo database of >4500 patients (pts) and their electronic medical records were screened. Of the 1200 pts with left ventricular (LV) ejection fraction (EF) >45%, only 60 pts met all inclusion criteria. Informed consent was obtained from 10 pts who were subsequently randomized and completed study protocols.|Pts meeting all inclusion criteria were most often excluded due to the presence of atrial fibrillation, being unable to perform the minimum exercise effort required, or walked > 550 meters on the 6MW test. The remaining pts were excluded for acute heart failure (HF) decompensation, baseline QTc > 500 ms or participation in another clinical trial .
734442|NCT01505166|This study recruited patients with colorectal carcinoma with liver metastases following resection and had successful manufacturing of Vigil (minimum of 4 doses). Part 1 would enroll the first 6 patients (Vigil plus chemotherapy) and then Part 2 would randomize subsequent patients (Vigil plus chemotherapy or Placebo plus chemotherapy).|3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. No other subjects were enrolled in Part 1 and also Part 2.
734484|NCT01500434|Enrollment of 102 patients was planned and 102 patients were enrolled at 30 sites in Australia, Belgium, France, Japan, Latvia, New Zealand, and the United States from February 10, 2009 to March 4, 2010.|
734485|NCT01500382||
734486|NCT01500317||
734487|NCT01500278|The study started to enroll patients in December 2011 and concluded in January 2016.|Participant Flow refers to the Randomized Treatment Group (RTG) that consisted of all subjects randomized into the study.
734443|NCT01505114|The study started the enrollment in June 2012. Accrual will occur in a staggered fashion, with men beginning first and women beginning several months later. Accrual for the men will occur over approximately 9 months, and accrual for the women will require approximately 9 months.|Exclusion--reactive HIV test results;Co-enrollment in any other HIV interventional research study; Use of ARV therapy; Prior history of any procedure altering the gastrointestinal tract or drug absorption; Receipt of prohibited medications; Known allergy to soy/peanuts; Weight>300 lbs;
734444|NCT01505062|In 2017, Sanofi suspended trials of SAR421869, while assessing its future. Until final decision was made, trial TDU13600 was not complete and in fact, further recruitment was planned. In 2019, Sanofi decided to terminate trial due to final decision on SAR421869, and shared decision with health authorities. Results have been reported expeditiously.|A total of 11 participants were screened. Nine participants of them were enrolled in the study with 3 participants in each of Cohorts 1 to 3. Due to early termination no participant was recruited in Cohorts 4 and 5.
734445|NCT01505010|From 28 March 2014 until 11 May 2016, 3 Belgian centers screened 29 patients, of whom 4 did not meet the criteria to enter the run-in period. Of 25 remaining patients, 8 were not eligible for randomization. Of 17 eligible patients, 9 were randomized to control and 8 to RDN. Of the 8 patients randomized to intervention, two did not undergo RDN.|
734446|NCT01504997||A total of 23 patients were recruited for the study, and the initial 5 cases were excluded from the primary analysis because some of the initial RAGs were performed by invited surgeons who had lots of experience. This exclusion was prespecified in the protocol. Therefore, only the remaining 18 patients were included in the analysis.
734447|NCT01504971||
734448|NCT01504958||
734449|NCT01504867|Participants were recruited between 1/2/2012 and 11/17/2014 at multiple US academic hospitals.|
734450|NCT01504854|A multicenter, double-blind, placebo-controlled trial was conducted June 2012-March 2014 with participants recruited from 26 US academic clinics affiliated with the Alzheimer's Disease Cooperative Study (ADCS).|119 subjects were recruited rather than 120.
734451|NCT01504841|The first participant was enrolled March 2013, and the final participant was enrolled June 2017. Participants were accrued from a total of 11 sites across Brazil, South Africa, and the USA.|Participants were stratified into the 3 Cohorts by age group and not randomized. There were no eligibility violations or errors to cohort assignments.
734452|NCT01504711||
734453|NCT01504477||
734454|NCT01504412|Participants who met all inclusion criteria and none of the exclusion criteria were enrolled and randomized to treatment.|Enrolled participants were equally randomized (1:1:1:1:1) to placebo, pregabalin, or one of three different doses of DS-5565 in a double-blind fashion. After randomization, participants received one-half the fixed dose for the first week, and subsequently received the fixed dose for 6 weeks. All participants were followed for an additional week.
734455|NCT01504204|Subjects were recruited from Wake Forest Baptist Medical Center Dermatology clinic and phone database of previously seen mild to moderate acne.|
734456|NCT01503749|Recruitment location: single medical center (Seoul National University Hospital) Recruitment period: between February 2012 and July 2013|Number of total enrolled pariticipants: 9 Number of screened participants: 14 Number of dropped participants: 5 (Withdraw consent:4, etc:1 due to development of hepatocellular carcinoma) Number of completed participants: 9
734457|NCT01503333||
734458|NCT01503164||
734459|NCT01503021||
734460|NCT01502956|Women who have persistent severe UUI symptoms, defined as ≥6 UUI episodes on a 3-day bladder diary are recruited from urology and urogynecology subspecialty clinics as well as by other marketing methods.|
734461|NCT01502787|25 subjects were screened but failed to meet inclusion criteria and were not included in treatment groups|
734462|NCT01502761||
734463|NCT01502709||
734464|NCT01502644|Volunteers with chronic low back pain (CLBP) and psychiatric illness (comorbid negative affect [NA]) were recruited to participate in this trial.|NA level determined by Hospital Anxiety and Depression Scale (HADS) score: Anxiety and Depression subscales with 7 questions each, each question scored 0 (least) to 3 (greatest) amount of anxiety/depression, total score 0-21. High NA=score ≥9 on each subscale, Moderate NA=score ≥6 to ≤8 on each subscale, Low NA=HADS score ≤5 on each subscale.
734465|NCT01502423||One participant, who was randomized to the New formulation of adalimumab/Current formulation adalimumab arm, discontinued before receiving any study drug.
734466|NCT01502410|Only Rhabdomyosarcoma and Wilms Tumor patients are reported as there were no accruals on Hepatocellular carcinoma and no accruals on Thyroid carcinoma.|
734467|NCT01502371||A total of 583 participants were randomized; 5 participants were randomized in error and did not receive any doses of randomized study drug.
734468|NCT01502332||
734469|NCT01502306|Recruitment was between July 2012 and May 2013|
734470|NCT01502293|Participants were enrolled at 6 investigative sites in the United States from 14 February 2012 to 21 March 2016.|
734471|NCT01502228|This protocol has 14 patients. Originally, 15 patients were planned, but lack of funding did not allow the final patient to be enrolled.|
734472|NCT01502033|10 participants recruited(and enrolled) from the Mayo Clinic Child and Adolescent Mood Disorders Clinic.|Participants were maintained on stable dosage of antidepressant medication for 4 weeks prior to enrollment and rTMS treatment.
734473|NCT01501955|Participants were recruited from all patients eligible for a total hip replacement from either of the investigators at the Bravis Hospital in Roosendaal, between October 2012 and October 2013.|Pre-operatively a DEXA scan was made to confirm eligibility.
734474|NCT01501929||32 subjects were enrolled in the study and 7 were subsequently excluded sure to various reasons, including pregnancy, normal BP of < 120/80 mmHg after the washout period of 3 week, inability to participate, and diagnosis with cancer.
734475|NCT01501162||
734476|NCT01501110|Consecutive patients with a diagnosis of acute myocardial infarction within 12 hours of evolution who underwent primary percutaneous coronary intervention and were admitted to the emergency and intensive care units of two tertiary hospitals in southern Brazil were recruited.|From the 83 patients enrolled, 15 met one of the following pre-established exclusion criteria: age younger than 18 or older than 80 yrs; primary thyroid disease; use of corticosteroids; chronic renal failure; severe hepatic insufficiency; severe immunosuppression; pregnant women or women undergoing postmenopausal hormone replacement.
734491|NCT01500200|Subjects were diagnosed with major depressive disorder (MDD) and had an inadequate response to 1 or 2 adequate courses of treatment with a commercially available antidepressant therapy (ADT) during the current major depressive episode (MDE). All subjects continued ADT for the duration of the study.|This was a Sequential Parallel Comparison Design (SPCD) study comprised of 2 stages. In Stage 1 subjects were randomized to ALKS 5461 or placebo (2:2:9). In Stage 2 only placebo non-responders from Stage 1 were re-randomized to ALKS 5461 or placebo (1:1:1). One subject randomized to placebo did not receive study drug.
734492|NCT01500187||
734493|NCT01500135|Participants took part in the study at 23 investigative sites in the United States from 09 March 2012 to 16 December 2015.|Participants who were elected for planned or subacute vascular surgery were enrolled in a 2:1 ratio to treatment groups: TachoSil® or Surgicel® Original.
734494|NCT01500109||
734495|NCT01500096|Study participants were recruited from 2/13/13 through 10/19/15 from local HIV specialty clinics.|Participants who met study criteria returned for an enrollment visit for randomization. Study drugs (placebo or ginseng) were dispensed by the Investigational Pharmacy. Participants were instructed to take study drugs daily for 28 days. They returned 2 wks after finishing taking study drugs for a final visit. No wash out or run-in periods.
734496|NCT01500083||
734497|NCT01500057||
734498|NCT01500031|There were 92 subjects enrolled at 12 investigative centers in Belgium, Germany and Switzerland from 26 April 2012 to 16 April 2013|
734499|NCT01499862|Patients were part of the hospitals patient population.|
734500|NCT01499849||
734501|NCT01499810|Consecutive patients admitted to our clinic for resistant hypertension were evaluated for eligibility according to selection criteria pre-defined in protocol of this study|83 patients with true resistant hypertension were identified, 12 rejected the intervention, 11 were excluded for anatomical reasons: atherosclerosis of renal arteries - 7, multiple narrow renal arteries - 2, fibromuscular dysplasia (FMD) - 1 and aneurysm of renal artery - 1. Finally 53 subjects were included and undergone renal denervation
734502|NCT01499667|Of the 158 patients screened, 142 patients were randomized.|142 Participants were randomized to 3 washout groups in a ratio of 1:1:1
734503|NCT01499654|Prospectively enroll patients with history of severe myocardial infarction, cardiomyopathy, heart failure or prior nuclear scans with resting perfusion defects. Patients were approached in the nuclear stress lab prior to scheduled stress test. Recruitment period was between 3/20/2012 and 2/14/2014.|
734504|NCT01499576|Dates of the recruitment period: From Oct 2011 to Mar 2012. Recruiting institute: Konyang University Hospital, via the outpatient clinic or General Examination Center.|
734505|NCT01499511||
734506|NCT01499498||
734507|NCT01499368||
734508|NCT01499355||A total of 276 participants were enrolled and 203 completed the run-in period and qualified for randomization; of these, 15 participants were not randomized.
734509|NCT01499303|This study was conducted in the US and UK. Patient enrolment was completed on 14 June 2013. However three patients, considered by the Investigator to still be receiving clinical benefit, continue to receive fostamatinib. A total of 102 patients were enrolled and 68 received Fostamatinib doses of 100mg or 200mg and 38 Screen Failures.|
734510|NCT01499290|Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA. First patient enrolled 22 March 2012 and last patient's last visit was 07 April 2014. Patients were adults hospitalised with complicated intra-abdominal infection (cIAI) that required surgery and IV antibiotics.|After obtaining written informed consent patients underwent a preliminary evaluation for eligibility within the 24-hour period prior to initiation of IV study therapy. eligible patients were randomized to 1 of 2 treatment groups in a 1:1 ratio according to the central randomization schedule.
734511|NCT01499277|Overall, 802 patients were enrolled from 111 centres in 6 regions in this study. The first patient was enrolled on 17 May 2012 and the last patient last visit was on 26 June 2014. Of 802 enrolled participants, 30 did not meet the eligibility criteria and 11 were randomized but not treated.|
734512|NCT01499199||Eligible participants received dolutegravir (DTG ) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) for 96 weeks.
734513|NCT01499173||
734514|NCT01499160|University Medical Centers and Hospital Based Oncology Programs recruited participants from July 2012 to December 2014.|All 7 patients (2 pts were HER2+ and 5 pts were HER2-) started the combination of lapatinib 1,500 mg/day and letrozole 2.5 mg/day.
734515|NCT01499147|We analyzed the clinical outcome of patients with hematological malignancies at standard or high-risk, who were transplanted (allogeneic peripheral blood or BMT HSCT) after receiving FluBU as a conditioning regimen. A total of 30 patients were recruited for this study which was conducted at the UIC Medical Center Inpatient BMT unit.|Criteria for FluBu conditioning: <60 years old; no diagnosis of myeloma or myelofibrosis (MF) in chronic phase; and not having received an autologous stem cell transplant with the last 2 years. Patients not fulfilling these criteria but still eligible for allogeneic transplantation were prepared with FluMel.
734516|NCT01499134||
734517|NCT01499095|A total of 1250 participants were screened, of whom 439 participants were screen failure and 811 participants were randomized.|Following the main 6 month treatment period, eligible participants previously using HOE901-U300 were randomized (1:1) in a substudy and continued with fixed-dosing (every 24 hours) or started a adaptable-dosing (at intervals of 24 +/- 3 hours) regimen for 3 Months (Month 6 to 9).
734518|NCT01499082|A total of 1177 participants were screened, of whom 370 participants were screen failure and 807 participants were randomized.|Following the main 6 month treatment period, eligible participants previously using HOE901-U300 were randomized (1:1) in a substudy and continued with fixed-dosing (every 24 hours) or started a adaptable-dosing (at intervals of 24 +/- 3 hours) regimen for 3 Months (Month 6 to 9).
734519|NCT01499043|A total of 6 participants received study drug at 2 clinic sites.|A total of 20 participants were planned to be enrolled at approximately 2 to 4 clinic sites.
734520|NCT01498991||
734521|NCT01498978||
734522|NCT01498952|The study was conducted in the USA.|Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. No participants were randomized in Phase 1b Cohort C part of the study as no dose limiting toxicity was observed in Phase 1b Cohort B.
734523|NCT01498887||This was an open-label, non-randomized, parallel group study.
734524|NCT01498822|This study started to enroll subjects in June 2011. A total of 27 investigators enrolled 353 subjects at 23 sites in Korea.|Participant Flow refers to the Randomized Set, consisting of all subjects who were randomized in this study.
734525|NCT01498744||
734526|NCT01498692|Enrollment of 94 patients was planned and 94 patients were enrolled at 23 sites in Australia, Belgium, France, Japan, New Zealand, and the United States from February 9, 2009 to December 10, 2009.|
734527|NCT01498679|A total of 311 participants were randomized to treatment. However, 4 participants were randomized in error and did not receive any study treatment. These participants were not included in the Intent-to-Treat (ITT) Population, which was comprised of all participants randomized to treatment who received >=1 dose of trial medication.|At screening, participants who met all of the inclusion criteria entered a 2-week Run-in Period. Participants continued on inhaled corticosteroid (ICS) therapy throughout the Run-in Period. At the end of the Run-in Period, participants meeting the randomization criteria entered a 12-week Treatment Period and received one of the two treatments.
734528|NCT01498653|A total of 313 participants were randomized to treatment. However, 4 participants were randomized in error and did not receive any study treatment; thus, these participants were not included in the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received >=1 dose of trial medication.|At screening, participants who meet all of the inclusion criteria entered a 2-week Run-in period. Participants continued on inhaled corticosteroid (ICS) therapy throughout the Run-in period. At the end of the Run-in period, participants meeting the randomization criteria entered a 12-week Treatment Period and received one of the two treatments.
734529|NCT01498640||
734530|NCT01498601|The retrospective study group included care-dependent adults with a primary diagnosis of neurological injury/insult (n=51) meeting the inclusion criteria. Enrolled subjects in the prospective study received the experimental protocol (n=32).|
734531|NCT01498588|This study was open to accrual from October 2011 to June 2015. Enrolled participants were from Winship Cancer Institute of Emory University and Emory University Hospital Midtown.|
734532|NCT01498575|From December 2011 to August 2012, participants were recruited from 5 sources: (1) local high schools; (2) The Children's Hospital of Philadelphia (CHOP) primary care practices; (3) local licensing centers; (4) community events; and (5) targeted ads in online venues. Fliers, letters, and ads describing the study were distributed via these channels.|A subset of the teens were assigned to complete the On Road Driving (ODA) assessment. Study participation lasted from 6-36 months based on licensure status - all dyads participated in the study for 6 months, after which participation continued until teens obtained their junior driver's license (up to a max of 36 months from enrollment).
734533|NCT01498549||
734534|NCT01498458||9 patients were registered in the study but patient number 9 withdrew consent immediately without receiving any Pazopanib.
734535|NCT01498445|Recruitment Period: June 2012 to April 2018|
734536|NCT01498419||
734537|NCT01498289||213 participants were randomized, but six were ineligible and 5 were excluded from analysis due to death or withdrawal prior to randomization. Therefore 202 were deemed eligible and analyzable for the primary analysis.
734538|NCT01498185|Of 171 participants enrolled, 76 completed a screening period. Of these 76 participants, 70 were randomized and received treatment. Of these 70 participants, 62 completed double-blind treatment period.|
734539|NCT01498120|This study started to enroll subjects in USA in January 2012 and concluded in December 2015.|Participant Flow refers to the Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication.
734540|NCT01498068|The study was conducted at 5 sites in Russia.|Of the 39 participants screened, 36 participants (16 treatment-naïve/ 20 treatment-experienced) were enrolled and treated.
734541|NCT01497938||
734542|NCT01497899|Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 28 December 2011. The last study visit occurred on 22 August 2016.|232 participants were screened for the Double-Blind Phase. 108 participants from other Gilead-sponsored Study GS-US-299-0102 joined the Open-Label Extension Phase.
734543|NCT01497860||
734544|NCT01497756||
734545|NCT01497665||
734546|NCT01497613||
734547|NCT01497496||
734548|NCT01497366|Subjects were enrolled in a total of 90 study sites in the United States, Australia, New Zealand, Canada, Sweden, Italy, and the Netherlands. The first participant was screened on 19 December 2011. The last participant observation was on 08 April 2013.|666 participants were screened and 527 were randomized; 499 participants received at least 1 dose of study drug, and comprise the Safety Analysis Set. The 496 participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug comprise the Full Analysis Set.
734549|NCT01497275|Recruitment started April, 2012 and closed to accrual May, 2014. Patients were recruited from the Cellular Therapy clinic at Duke.|
734550|NCT01497262||
734551|NCT01497197||
734552|NCT01497171|5 women were enrolled at the German site (St. Hedwig's). No subjects were enrolled at the US sites.|
734553|NCT01497067|This study enrolled subjects at 20 investigative sites located in the US, 9 investigative sites located in the European Union, and 5 investigative sites located in Canada.|This reporting group includes all enrolled subjects.
734554|NCT01496846|Protocol enrollment: 201 subjects with 1 study tooth.|"All enrolled study participants (N=201) initially received an Articaine inferior alveolar nerve block (IANB).
~If unsuccessful (N=149), this was followed by a supplemental dose (SUP) of either Articaine or Lidocaine.
~Fifty-two subjects were excluded prior to assignment to groups due to inadequate lip numbness (N=2) or successful IANB (N=50)."
734555|NCT01496807|Between February 17, 2012 and December 5, 2013, 33 patients were screened and 31 patients were enrolled on treatment at Moffitt Cancer Center.|
734556|NCT01496469|Participants took part at 29 sites in the United States from 10 January 2012 to 04 August 2014.|Participants with a historical diagnosis of hypertension along with hyperuricemia were enrolled in 1 of 2 treatment groups as follows: Placebo; Febuxostat 80 milligram (mg).
734626|NCT01491607|Participants were enrolled from 9 November 2011 to 9 May 2012 at four medical centers in the U.S.|All enrolled participants met the inclusion and exclusion criteria.
757773|NCT00201864|Patients were enrolled between November 2005 and December 2009|
734557|NCT01496456|Recruitment was not as expected and halted after one year. Local options to enhance patient accrual were exhausted. The total patient pool was small, but of sufficient scientific value to continue and complete the study.|Paired, split-mouth study design: Each patient received at least 1 pair of 2 treatments (one of each arm). Eligible tooth pairs selected for similarity. Random allocation of treatment to study teeth of each tooth pair.
734558|NCT01496430|Participants took part in the study at 41 investigative sites in the United States from 09 January 2012 to 30 May 2013.|Participants with a diagnosis of stage 1 essential hypertension and type 2 diabetes mellitus uncontrolled on metformin were enrolled equally in 1 of 3 treatment groups, once a day placebo, 40 mg or 80 mg TAK-491.
734559|NCT01496352|Study Period: February 12, 2012 to June 27, 2013. Patients were enrolled at four hospital based sites in the US (Tampa, FL; Temple, Tx; Florence, AL; Houston, TX).|
734560|NCT01496313|From 8 June 2012 to 2 April 2014, 81 participants were randomized by 29 centers in 9 global countries.|93 participants were screened; 81 participants were randomized to treatment.
734561|NCT01496287||
734562|NCT01496274|Subjects were enrolled from 30 sites in 10 countries.|A total of 69 subjects provided informed consent and were screened for study participation. Of these, 63 subjects were enrolled and treated with rIX-FP.
734563|NCT01496248||
734564|NCT01496183||
734565|NCT01496157||2 enrolled participants were screen failures, therefore 13 started the study.
734566|NCT01496131|First subject First Visit/Last Subject Last Visit: 24 October 2011/25 November 2016.|
734567|NCT01496066||
734568|NCT01495988|Eight subjects were randomized under protocol v2.0 with the first subject enrolled on 8/13/2013. Two subjects were enrolled under protocol v4.0 with the first subject enrolled on 6/19/2015. The study was permanently closed on 6/13/2016. All subjects were recruited from Melanoma Research Foundation Breakthrough Consortium (MRFBC) clinical sites.|Participants has to meet the eligibility criteria prior to enrollment into the study.
734569|NCT01495975||
734570|NCT01495923|Between December 15, 2011 and June 10, 2014 145 participants were recruited at 8 sites. The sites included 4 joint service military treatment facilities, 3 of which serve as teaching hospitals and 1 of which is located in Europe; a Veteran's Administration hospital; and 3 civilian teaching hospitals.|
734571|NCT01495858||
734572|NCT01495793|This was a multicenter study in which 42 subjects were enrolled and 24 treated at 8 sites in the USA.|In total 42 subjects signed the informed consent and were enrolled into the study (Enrolled Set). 24 of these subjects were treated with medication. The sample size of 24 subjects was sufficient to target a 95% confidence interval and the calculation was based on a previous study. Participant Flow refers to the 24 treated subjects (Safety Set).
734573|NCT01495702|Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 13 December 2011. The last study visit occurred on 01 December 2014.|571 participants were screened.
734574|NCT01495689||
734575|NCT01495585||In Group 1, participants were randomized either placebo or lonafarnib 100 mg. In Group2, participants were randomized into either placebo or lonafarnib 200 mg.
734576|NCT01495572|Due to slow accrual, the investigator decided to close the study.|
734577|NCT01495481||"All 22 patients recruited received both adenosine and dexmedetomidine. Adenosine was administered first ,and then SVT was reinduced. Once SVT was reinduced, dexmedetomidine was administered.
~The washout period was not constant because it was dependent upon the reinduction of SVT, but it was generally less than 10 min."
734578|NCT01495286|Recruitment period started 12/15/11, ended 06/21/12. All recruitment took place in the well mothers and babies (rooming-in) unit at the University of Arkansas Medical Center (UAMS). Parents of infants were contacted in their individual rooms by research staff and parents signed IRB -approved consents if they wanted their infants to participate.|The parents of one infant signed the consent form but then changed their minds before the infant actually participated in the study. This infant was withdrawn from the study.
734579|NCT01495221||
734580|NCT01495000||The study consisted of a Screening Phase of up to 2.5 months and a 6-month Double-blind Treatment Phase. A total of 551 participants (par.) were screened; 303 par. were screen failures, and 250 par. were randomized (2 par. were considered to be screen failures; however, these par. were randomized, 1 to each treatment group).
734581|NCT01494987|Participants were enrolled (during the Qualifying Period) at a total of 103 study sites in Asia, Europe, South Africa, and the United States. The first participant was screened on 12 January 2012. The last participant observation occurred on 28 August 2013.|595 participants entered the qualifying period (355 required and completed the glimepiride stabilization period); 431 were randomized and treated (Safety Analysis Set). Of these, 14 were excluded due to major eligibility criteria protocol violation or had no baseline or ontreatment data; thus, 417 were included in the Full Analysis Set.
734582|NCT01494818|Participants were recruited from one study center located in the United Kingdom.|Of the 79 participants enrolled in the study, 1 participant exited the study between enrollment and product dispensing due to nonavailability. This reporting group includes all enrolled and dispensed participants.
734583|NCT01494753||
734584|NCT01494649|Participants were recruited at the clinical site|
734585|NCT01494610||
734586|NCT01494584|Enrolled participants (par.) were aged 12 years to less than 18 years with partial onset seizures or Lennox-Gastaut syndrome (LGS), and were required to be on at least 1 but not more than 3 anti-epileptic therapies without achieving complete control of their seizures.|A total of 5 par. who met the eligibility criteria were assigned to Regimen A (>50 kilograms [kg]) or B (30 to <=50 kg) based on body weight and entered a 2-week Screening phase, followed by a dosing phase (up to 5 weeks). Upon completion of the dosing phase, par. either entered a follow-up phase or a separate extension study.
734587|NCT01494545|Participants were recruited from study centers in Europe.|This reporting group includes all enrolled participants.
734627|NCT01491490|Recruitment was problematic due to the restrictive entry criteria (one subject screened in the first 5 months). Even after implementation of a protocol amendment to improve recruitment, only 12 subjects were screened and two randomised. It was decided that it would be impossible to complete the study in a meaningful timeframe so it was terminated.|There were a high proportion of screen failures due to most subjects failing to comply with one or more of the eligibility criteria.
757774|NCT00201851||
734588|NCT01494532|Eligible participants(par) were diagnosed with advanced stage idiopathic Parkinson's Disease (PD), demonstrated lack of control with Levo(L)-dopa therapy, and on a stable dose of L-dopa for a minimum of 4 weeks prior to screening. Par were randomized into one of six treatment arms to receive placebo or ropinirole prolonged release(PR) tablets.|After screening, par underwent a 13 Week up-titration period until reaching their target dose then continued on their target dose during a 4 Week Maintenance Period up to Week 17. All par underwent a 1 Week down-titration period and then a follow-up visit 2 Weeks after receiving the last dose of study medication.
734589|NCT01494506|"Patients were randomized over a period of 1.9 years starting from 2012-01-11 to 2013-09-11.
~The study was initially a two-arm study with MM-398 monotherapy and 5-FU/LV control (protocol version 1) . A third arm of MM-398+5-FU/LV was added later (protocol version 2)."|All patients were screened for UGT1A1*28 allele at baseline.
734590|NCT01494467||
734591|NCT01494350|184 total screened and there were 134 screen failures.|
734592|NCT01494298|Inclusion criteria were male gender, African American by self report and not taking of lipid-lowering medications. Subjects with diabetes were recruited from the Grady Diabetes Clinic in Atlanta, Georgia. Control subjects were recruited from the general Metro-Atlanta Area and had to have a fasting blood glucose <100 mg/dL.|"1 subject was excluded from the diabetes group because he had type 1 diabetes
~Exclusion from control group 1- was taking lipid lowering medications
~1 - was not possible to do venous blood draw 5 - FBG between 100-126 mg/dL 2 - FBG>126 and were reassigned to diabetes group"
734593|NCT01494051||
734594|NCT01494038|HIV-infected pregnant women and their infants, gestational age greater than 14 but less than 34 weeks, who reside in a high TB prevalence area. Recruited at participating medical clinics in those areas, a total of 13 sites in Haiti, India, Thailand, and in 5 countries in central and southern Africa. Recruitment from August 2014 to April 2016.|
734595|NCT01493960|There were 162 subjects screened. Whereof 31 did not meet the criteria|There were131 patients randomly assigned in a 2:1 allocation to receive 2 rectal doses of cobitolimod at 30 mg, or placebo, respectively.
734596|NCT01493947||
734597|NCT01493778|Participants were enrolled at 40 sites in 15 countries: Algeria (1 site), Austria (2 sites), China (6 sites), Denmark (1 site), Greece (2 sites), Hong Kong (1 site), Hungary (1 site), Japan (2 sites), Lithuania (1 site), Poland (2 sites), Russian Federation (2 sites), Serbia (1 site), Spain (3 sites), Turkey (3 sites), United States (12).|Sixty (60) participants were enrolled in the trial and received at least one dose of turoctocog alfa.The trial consisted of two phases: the main phase including the screening visit (visit 1) and 4 subsequent visits, and an extension phase with a rolling visit schedule consisting of 6 planned visits including 4 dispensing visits) per year.
734598|NCT01493687||
734599|NCT01493557||This is a Prospective, randomized, open label trial. 1067 patients treated with Pradaxa and 117 patients were randomized to a management strategy. NVAF= non-valvular atrial fibrillation and GIS = gastrointestinal symptoms.
734600|NCT01493531||
734601|NCT01493427|Subjects were recruited from 15 investigative sites located in Europe: Belgium (2); Spain (6); Italy (4); Sweden (3).|Of the 202 subjects enrolled, 1 subject was exited as a screen failure and 2 subjects withdrew consent prior to dosing. This reporting group includes all subjects who instilled at least one dose of the test article (199).
734602|NCT01493414|This was an expanded access study intended to provide an access path to ruxolitinib for patients with Myelofibrosis (MF) and to allow for collection of additional safety and efficacy data for ruxolitinib.|
734603|NCT01493284||
734604|NCT01493180||
734605|NCT01493167||
734606|NCT01493089||
734607|NCT01493024|Participants took part in the study at 9 centers in the United States from 28 November 2011 to 22 May 2012.|Combined Placebo Group
734608|NCT01492686||
734609|NCT01492673||
734610|NCT01492582||
734611|NCT01492439||
734612|NCT01492426|A total of 793 participants were recruited at 90 sites in 15 countries.|Of the 793 participants, 605 were randomized to treatment. A total of 191 enrolled subjects did not enter the treatment period as they no longer met study entry criteria and a 602 participants were received treatment.
734613|NCT01492400||
734614|NCT01492309||22 participants were eligible at screening to be enrolled into the treatment arm of the study.
734615|NCT01492088|Participants took part in the study at 12 investigative sites in United States, France, Germany, Netherlands, United Kingdom, Italy, Spain and Mexico from 16-April-2012 to 12-April-2018.|Participants with diagnosis of relapsed or refractory (r/r) sALCL/HL were enrolled to receive brentuximab vedotin 1.4-1.8 mg/kg, intravenous infusion on Day 1 of every 21-day cycle for up to 16 cycles. Treatment beyond 16 cycles was permitted at joint discretion of sponsor and investigator for participants experiencing continued clinical benefit.
734616|NCT01491984|From July 29,2009 to March 12, 2010 we recruited women aged 16-75 yrs old, ASA class I-II, and undergoing elective gynecologic surgery at the IWK Health Centre under general anesthesia with planned orotracheal intubation.|105 participants were consented and randomized, and of those 11 were withdrawn for either anticipated difficult airway, decreased SpO2, or unavailable staff/equipment. A total of 94 participants started the study protocol. 3 were withdrawn. 91 participants completed the study protocol.
734617|NCT01491958|Patients who are candidates for HSCT using HLA matched related donors were eligible to be enrolled in the study.|
734618|NCT01491919||
734619|NCT01491893||
734620|NCT01491854|130 participants signed informed consent. Of the 130 enrolled subjects, 11 subjects had no post-baseline visit, leading to exclusion from the SAF/FAS. Another subject was excluded as he received treatment with Omnitrope, which was not consistent with the protocol. Accordingly, 118 subjects comprised the SAF and in the FAS|SAF : safety Analysis set FAS : full Analysis set
734621|NCT01491841|The study opened November 1, 2011 and closed to accrual September 22, 2016. Subjects were recruited through the Hematology Clinic at Duke University Medical Center.|
734622|NCT01491802|Participants were enrolled between March 2012 and June 2014.|There was run-in period of approximately 2 weeks for determination of eligibility and familiarization with all tests to be performed during subsequent treatment visits. There was a 2-week washout period between each 4-week treatment period of this crossover study.
734623|NCT01491737||A total of 258 participants were enrolled in the study.
734628|NCT01491178|Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation|6772 subjects were enrolled. Among them, Electronic Case Report Form (eCRF) was not collected for 144 subjects and 185 subjects were excluded because of them not following registration rule, no actual visit or previous treatment experience with Prazaxa, leaving 6443 subjects eligible for study who were enrolled and included in the final study.
734629|NCT01491113|The Participant Flow refers to the Safety Set population which includes all patients that received at least one dose of study medication.|About 30 (28 to 30) subjects were planned to be enrolled for 5 groups (A to E) according to their renal function based on the value of creatinine clearance (CLCr).
734630|NCT01491035||
734631|NCT01491022||
734632|NCT01490931|Consecutive patients in PENN periodontal clinic or faculty practice requiring 1 to 3 dental implants employing lidocaine with epinephrine for anesthesia without significant bone augmentation|Subjects not experiencing moderate pain (at least 40 mm on the pain intensity VAS and moderate or severe pain on the 4-point categorical scale) within 4 hours of surgery were not dosed with ketorolac. Of the 28 enrolled subjects, 25 (89%) achieved at least moderate pain and were dosed.
734633|NCT01490918||
734634|NCT01490892||
734635|NCT01490866|Between January 2012 and January 2014, 70 patients with histologically or cytologically confirmed metastatic carcinoma of colon or rectum were enrolled and treated. The trial was conducted at 12 sites in the United States.|In this non-randomized open label trial, patients began treatment with FOLFOX/bevacizumab every 4 weeks for 16 weeks. Patients with objective response or stable disease began Axitinib maintenance therapy at week 17. Axitinib therapy continued until disease progression, unacceptable toxicity or did not meet any criteria for discontinuation.
734636|NCT01490840|Participants were randomized1:1 to receive a structured physical intervention (e-training) or no physical intervention (waiting).|At the end of the 6 month core phase (phase 1), participants in the waiting group had the option to receive e-training for 6 months in the phase 2 optional extension. Participants in the e-training group had the option to continue their e-training for another 6 months in the phase 2 extension.
734637|NCT01490814||769 subjects were enrolled; 7 subjects exited prior to randomization, 762 were randomized
734638|NCT01490788||
734639|NCT01490723||
734640|NCT01490697||
734641|NCT01490684||
734642|NCT01490632|Participant Psoriasis Area and Severity Index (PASI) score at the conclusion of Part A stratified participants as either Responder (PASI ≥75), Partial Responder (PASI 50 - PASI 74), or Non-Responder (PASI <50).|Part A: Initial Treatment Period (Weeks 0 up to 12) Part B: Extension or Step-Up Period (Week 12 up to Week 24) Part C: Washout or Step-Down Period (Week 24 up to Week 40) Part D: (Re-Treatment Period up to 52 Weeks)
734643|NCT01490580|The trial was prematurely interrupted for logistic reasons in July 2016: a fourth drug manufacturing run was necessary because the intralipids had passed their expiration date and funding had run out. During the study period, 755 patients were screened for eligibility, and 173 randomized|
734644|NCT01490359||
734645|NCT01490294||
734646|NCT01490190||
734647|NCT01490151||
734648|NCT01490125|247 patients were randomized. Of these 247, one patient was misrandomized, did not receive study treatment and was excluded from any analysis set. Of 246 patients, 191 completed the study. This is a crossover study; therefore, participants are counted more than once depending on their dosing sequences.|Participants were randomized to 1 of 6 treatment sequences to receive 1 of 3 treatment combinations; then, crossed to the other 2 possible treatment combinations for a total of 3 treatment periods. Each treatment combination period was followed by a 14 day washout.
734649|NCT01490086|270 Subjects with acute exacerbation Schizophrenia and Schizoaffective disorder were selected from multiple sites in USA, Moldova, India, Philippines and Malaysia between December 2011 and January 2013.|Subjects were screened over a period of 7 days in the site's in-patient facility. 270 subjects were recruited. Of these, 36 subjects did not meet the study eligibility criteria. Therefore, a total of 234 subjects were enrolled into the study.
734650|NCT01490073||
734651|NCT01490060|Recruitment Period: May 21, 2012 to January 23, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
734652|NCT01489969||
734653|NCT01489956|One site in the United States recruited 19 healthy adult male and female participants.|The accrual objective was 10 to 20 evaluable participants in Part A and 10 evaluable participants in Part B. The definition of an evaluable participant (measured/determined by lymphocyte proliferation assay) was provided in the protocol.
734654|NCT01489891|All patients over 18y with instructions for diagnostic or therapeutic EGD referred to the Endoscopy Unit of the Infanta Cristina Hospital for sedation were included successively. All patients was referred to the Infanta Cristina Hospital Endoscopy Unit in Parla, Madrid, Spain, for an EGD between January and May 2012.|The exclusion criteria were instructions for urgent endoscopy, encephalopathy, zero patient cooperation, lack of informed consent, not having fasted, a history to developing methemoglobinemia, pregnant women, lactating mothers or known allergies to propofol or lidocaine. All the patients provided their informed consent beforehand
734655|NCT01489826||
734656|NCT01489670||Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. There was no investigational drug administered in this study.
734657|NCT01489579|A total of 347 patients were identified as eligible for study participation study personnel contacted the patient by telephone approximately 2 weeks prior to her or his scheduled SOC encounter to describe the study and obtain verbal consent for enrollment. 192 were consented.|Seventy-two subjects did not obtain scheduled laboratory data or have contact with a clinical pharmacist during the study time period resulting in 120 subjects, 56 and 64 in the control and intervention groups, respectively, enrolled in the study.
734658|NCT01489527|Women residing in the Western Cape, South Africa were enrolled from November 2012 to July 2013 in a preparedness study. Participants were recruited from the Kraaifontein day hospital and the Bloekombos primary health care clinic by community workers and through word of mouth, flyers, and brochures.|4 of the 406 participants randomized had a false HIV negative test result, reducing the participants to 202 in the Gardasil Arm and 200 in the Placebo Arm.
734659|NCT01489358|Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland from December 12, 2011 to March 22, 2012|
734660|NCT01489254|Subjects were randomized at 118 investigational sites in 17 countries.|1549 patients were assessed for eligibility of whom 796 subjects were randomized in a 4.3:4.3:1 ratio to receive generic glatiramer acetate (GTR), brand glatiramer acetate (Copaxone) or matching placebo. Two subjects were randomized to the generic glatiramer acetate group but did not start treatment and were not enrolled.
734661|NCT01489189|"Participants with 2 eyes in the study had 1 eye randomly assigned to receive ranibizumab and 1 eye to receive panretinal photocoagulation.
~Two-year completed visits include those that occurred between 644 and 812 days (between 92 and 116 weeks)."|
734662|NCT01489111|The trial was conducted at 26 sites in 13 countries, as follows: Australia (1 site), Denmark (1 site), France (3 sites), Hungary (1 site), Israel (1 site), Italy (2 sites), Japan (2 sites), Malaysia (1 site), Netherlands (1 site), Switzerland (2 sites), Turkey (3 sites), United Kingdom (4 sites) and United States (4 sites).|36 participants were screened and exposed to the trial product. A total of 53 surgeries were planned in these 36 participants and 49 surgeries were completed. The results are analysed and presented based on the number of surgeries instead of number of participants. Participants in this trial were also enrolled in the NN7088-3859 trial.
734663|NCT01489020||
734664|NCT01488994|Enrollment was conducted at 11 clinical sites in 6 countries (United Kingdom, Poland, Romania, Russian Federation, Ukraine, India). A total of 23 participants were enrolled in the study. Of these, 11 were < 6 years of age and 12 were 6 to <12 years of age.|
734665|NCT01488890|Study participants were enrolled from 06 December 2011 to 22 March 2012 in the United States.|A total of 390 participants were enrolled and randomized in the study.
734666|NCT01488877||Total 6 participants were enrolled in the study. Study was terminated early after partial completion of Cohort 1 (PF-03882845 3 milligram (mg)/placebo) and Cohort 4 (spironolactone 25 mg/placebo); Cohort 2 (PF-03882845 1 or 10 mg/placebo) and Cohort 3 (PF-03882845 1, 10 or 30 mg/placebo) were not enrolled.
734667|NCT01488708||
734668|NCT01488578||
734669|NCT01488487||Of the 33 participants screened for eligibility, 24 were deemed eligible and went on to treatment, 8 were ineligible, and 1 participant withdrew consent prior to treatment assignment.
734670|NCT01488448||
734671|NCT01488409||
734672|NCT01488370||
734673|NCT01488318||
734674|NCT01488279||
734675|NCT01488188|Recruit volunteers at Clinical Trial Center in Seoul National University Hospital|Randomly group assignment
734676|NCT01488097||9 participants who completed Study LAL-CL01 (received all 4 doses of sebelipase alfa) were screened for eligibility for enrollment in this extension study (LAL-CL04). 8 participants met all enrollment criteria and were enrolled. 1 participant who required a liver transplant no longer met the entry criteria.
734677|NCT01488071|In- or outpatients who had been treated with antidepressant selective serotonin reuptake inhibitor (SSRI) or selective noradrenaline reuptake inhibitor (SNRI) monotherapy that was prescribed to treat a single episode of Major Depressive Disorder (MDD) or recurrent MDD.|The study will consist of a screening period of 4 to 10 days before the Baseline Visit, followed by a 12-week treatment period with vortioxetine or agomelatine. A safety follow-up will be done approximately 4 weeks after the Completion/Withdrawal Visit.
734678|NCT01488019||
734679|NCT01487954||
734680|NCT01487863||
734681|NCT01487668|Overall, 287 subjects completed baseline assessments, and 245 completed both baseline and 12-month follow-up assessments, and the 245 are included in final analyses, with 124 in the treatment (LGCC) group and 121 in the control (usual care) group.|304 participants enrolled in the project, but only 287 completed baseline assessments, so those will be the participants included in the baseline analysis.
734682|NCT01487577|Candidates are identified through the investigators' clinical practice.|
734683|NCT01487525||44 subjects were enrolled. Prior to starting the study, 2 participants dropped out due to lack of time. Since they discontinued after consent, but prior to any measurements or interventions, no data is available for these 2. Data is available for the 42 subjects who started the study.
734684|NCT01487499||
734685|NCT01487265||
734686|NCT01487200|This study took place at 2 centers, both located in Australia. Enrollment for this study took approximately 1.5 months.|Subjects were screened for eligibility within 14 days of being randomized
734687|NCT01487161|This study took place at 22 centers across the United States, Canada and Australia. Enrollment took approximately 7 months.|Subjects were screened within 21 days of being randomized
734688|NCT01486966|A total of 6 centres in China participated.|Between screening and treatment with trial drugs, subjects were assessed for eligibility and were randomised 1:1 into one of the two treatment arms.
734689|NCT01486927|This multicenter, multinational study enrolled subjects at 54 participating study centers in the United States, Japan, Europe, Australia, Canada, Lebanon, Malaysia, Philippines, Russian Federation, South Africa, and Ukraine.|Screening took place 4 to 28 days prior to first dose of study product (rVIII-SingleChain). A total of 204 subjects were screened, 29 of these did not fulfill all eligibility criteria and were therefore screening failures. A total of 175 subjects were enrolled; 174 subjects were exposed to treatment with rVIII-SingleChain.
734690|NCT01486810||
734691|NCT01486758||
734692|NCT01486615|Recruitment period was of three months. Approximately 90 minutes prior to surgery, each patient was taken to a quiet room inside the operation theater complex.|One hundred and ten patients were assessed for eligibility, 98 patients had anxiety VAS ≥3. Among them, 80 patients who met the inclusion criteria, were enrolled and assigned into four groups.
734693|NCT01486446||
734694|NCT01486316||
734695|NCT01486264|The study was conducted at 43 sites in the United States.|A total of 283 participants were screened and randomized in the study. Of these, 282 participants were treated and 207 participants completed the study.
734696|NCT01486238|Patients will be recruited from a single medical clinic (Valley Retina Institute), and randomly assigned 2:1 to Macugen® every 4 weeks (IVMac q4 arm) or Macugen® every 6 weeks (IVMac q6 arm). If both eyes are eligible, then one eye will be randomized into the trial.|All enrolled patients must have DME in one or both eyes. In patients with both eyes that meet criteria, only 1 eye will be considered eligible. All fellow eyes in these patients will be treated according to standard clinical guidelines.
734697|NCT01486199||
734698|NCT01486043||
734700|NCT01485887||Participants who have completed the week 8 visit in the preceding double-blind study B2411263 (NCT01441440) were eligible to participate in this study.
734701|NCT01485796|Enrollment was conducted at 16 study sites in the US.|Of 54 subjects screened for the study, 37 started treatment. Of the 17 subjects who discontinued the study before treatment, 10 were screen failures, 5 withdrew consent, and for 2 subjects enrollment ended due to other reasons.
734702|NCT01485640||
734703|NCT01485627|54 physicians were assessed for eligibility. Of these 2 were ineligible and 9 refused participation. 43 physicians were included in the pre-randomized phase and of these 2 withdrew and 3 did not enroll enough patients. Patients from 38 physicians were included for the cluster randomized clinical trial phase of the study.|233 caregivers and 316 patients were consented. 204 caregivers were allocated and 127 of them were bereaved. 24 caregivers failed screening and 5 withdrew during screening. 26 patients failed screening and 9 withdrew during screening.
734704|NCT01485614|The study recruited participants in clinics/clinical offices in 42 countries.|"Participants in a one-week, run-in received sitagliptin placebo prior to morning meals and metformin placebo prior to morning and evening meals.
~Participants enrolled in the metformin and placebo/sitagliptin arms prior to implementation of Protocol Amendment 05 completed the study on their original treatment assignments."
734705|NCT01485588||
734706|NCT01485536|Recruitment Period: August 28, 2016 to June 17, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of 26 participants screened for enrollment, five were not eligible therefore excluded from the study before any treatment assignment.
734707|NCT01485393||
734708|NCT01485380||
734709|NCT01485354|Subjects were recruited primarily among the outpatient population of stroke survivors at Spaulding Rehabilitation Hospital. We primarily relied upon a registry of stroke survivors who had agreed to be contacted for research studies with focus on stroke rehabilitation.|
734710|NCT01485172|Eligible participants (par.) were diagnosed with early stage Parkinson's disease (according to modified Hoehn and Yahr criteria Stages I-III) and randomized at Screening into one of six treatment arms to receive placebo or ropinirole Prolonged Release (PR) tablets.|After Screening, par. underwent a 13 Week Up-Titration Period until reaching their target dose then continued on their target dose during a 4 Week Maintenance Period up to Week 17. All par. underwent a 1 Week Down-Titration Period and then a Follow-Up Visit 1-2 Weeks after receiving the last dose of treatment.
734711|NCT01485120||
734712|NCT01485094|The first participant was enrolled on the 23 Feb 2012 and the last participant completed the trial on the 18 Jan 2013. A decision to terminate the trial was taken on 18 Dec 2012 after the results of an interim analysis.|114 participants signed informed consent to participate in the trial. 59 participants of the planned 90 were randomized and 57 received study drug (investigational medicinal product).
734713|NCT01485055||
734714|NCT01484977|The recruitment for the SP0980 study began in December 2011. It concluded in January 2014. This was a multicenter study with subjects enrolled by 30 sites across North America, 12 in Western Europe, 10 in Eastern Europe, and 2 in Oceania.|The participant flow consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
734715|NCT01484951|Subjects were recruited from 3 study centers in Taiwan.|
734716|NCT01484938|Participants were recruited from 3 study centers in the Netherlands, 3 study centers in Sweden, and 1 study center in Australia.|
734717|NCT01484912|First Patient Enrolled: May-10-2007 Last Patient Completed: Jun-17-2008|Patients underwent one-week screening and washout period prior to randomization
734718|NCT01484873|University clinics and online advertisements from June, 2012 - March, 2013|
734719|NCT01484834|Administrative workplace|
734720|NCT01484652||
734721|NCT01484626|Participants were recruited from May 2011 through April 2014 (36 months) from the Cardinal Bernardin Cancer Center at Loyola University Medical Center|There are no pre-assignment details to report
734722|NCT01484561||
734723|NCT01484496|Participants (Par.) with active systemic lupus erythematosus (SLE) and who were on appropriate stable standard SLE therapy for a period of at least 30 days prior to Day 0 before entering the study were eligible for participation in the study.|A total of 1427 par. were screened, out of these 588 par. were screen failures and 839 par. were randomized, of which 836 par. received at least one dose of study treatment. Par. who successfully completed the initial 52-week Double-blind Phase had a choice to enter into a 6-month Open-label Extension Phase of this study.
734724|NCT01484431|Per protocol, the summary was based on weight cohorts.|This study contains 2 periods: Pharmacokinetics(PK)/safety Period 1 and an open-label safety extension Period 2. Period 1 is approximately 10 weeks (that is, approximately 5 consecutive weeks for each dose [low and high]). Period 2 is at least 2 years after participating in Period 1.
734725|NCT01484340||
734726|NCT01484314||
734727|NCT01484275||
734728|NCT01484197||
734729|NCT01484132|A total of 113 children aged 3-17 were enrolled in Composites and Urinary Bisphenol-A Study (CUBS) across 8 dental clinics in Massachusetts between February 2012 and December 2013. Follow-up visits were completed in June 2014.|
734730|NCT01484054||Of those 103 enrolled subjects, 3 subjects did not receive the study article.
734731|NCT01484041||
734732|NCT01484028||Of those 275 enrolled subjects, 267 subjects were randomized and received the study article in the study. Two subjects were discontinued between the first and second periods.
734733|NCT01483963||
734734|NCT01483937|Recruitment continued for one year resulting in 39 subjects pre screened for inclusion in the study.|Seven subjects who had signed Informed Consent prior to inclusion/exclusion screening failed screening: thirty-two subjects participated in the physical therapy protocol.
734735|NCT01483924||
734736|NCT01483872||9 patients signed consent forms. Only one developed an active infection and thus underwent randomization.
734737|NCT01483820||
734738|NCT01483807||Each participant received each treatment arm in this cross-over design. Order of treatment assignment was random.
734739|NCT01483690|This is a pilot study where 16 patients are anticipated to be enrolled. Anticipated enrollment will take 2.5 years.|
734740|NCT01483651||
757775|NCT00201838||
734741|NCT01483625|In this 12-week, randomised, double-blind, placebo-controlled, parallel group, multi-center Phase IV trial in chronic obstructive pulmonary disease (COPD), 140 patients were randomised to either Tiotropium 18 mcg or Placebo. Sixty eight (68) patients received Tiotropium 18 mcg and seventy two (72) patients received Placebo.|
734742|NCT01483599||
734743|NCT01483560||493 participants where enrolled and consented. All participants entered a 3 month Run In phase with placebo. Participants who remained eligible were randomly assigned to receive metformin or placebo for 3 years. 65 participants where ineligible to be randomized.
734744|NCT01483378|We prospectively recruited eligible patients from the Bellevue Eye clinic until 100 patients were prescribed and received the vaccine. Recruitment occurred from January 9, 2012 to February 12, 2012.|
734745|NCT01483352||
734746|NCT01483209||
734747|NCT01483183|This trial was conducted in 40 participants at 10 trial sites in the following 3 countries: Germany, Spain, and the United States.|The trial consists of two parts (Part 1 and Part 2). Each part evaluates two populations of participants for cardioversion in a hospital setting; one diagnosed with paroxysmal atrial fibrillation (AF) and the second diagnosed with persistent AF. However, Part 2 was not conducted and therefore is not included in this document.
734748|NCT01483118|Advertizing in newspaper beginning in August 2011|
734749|NCT01482962|Participants took part in the study at 105 investigative sites in the United States including Puerto Rico, Canada, European Union, Russian Federation, Turkey, Israel, Australia, New Zealand and Latin America from 11 June 2012 to the end of study on 18 December 2017.|Participants with a diagnosis of Relapsed or Refractory Peripheral T-Cell Lymphoma were randomized 1:1 to either alisertib or comparator (investigator's choice of pralatrexate, romidepsin [USA only], or gemcitabine).
734750|NCT01482910||
734751|NCT01482884|147/111 patients were enrolled/randomized from 31 centres in 6 European countries. The first patient was enrolled on 26 March 2012, and the last patient completed the study on 24 June 2013.|Participants were enrolled for a period of 3 weeks.
734752|NCT01482819||
734753|NCT01482767|Participants were enrolled from May 2012 to December 2013 at 42 U.S. sites.|
734754|NCT01482715|The study was conducted at 15 investigative sites in the United States (6 sites), United Kingdom (5 sites), Spain (1 site), Israel (2 sites), and Canada (1 site).|
734755|NCT01482598|5 subjects not randomized. 139 Subjects randomized in 2 arms|
734756|NCT01482429|Adult patients hospitalized in the intensive care unit, remained on mechanical ventilation for more than 24 hours and subjected to weaning from mechanical ventilation.|
734757|NCT01482351|From 9/2012 to 12/2014, study investigators identified potential participants from clinical practices, advertisements in newspapers, clinical trials registries, senior centers, advertisements in public transportation centers, the Alzheimer's Association, and support groups.|
734758|NCT01482325||
734759|NCT01482312|Twenty-nine participants were randomized into one of three treatment sequences. The study took place at one site, which was located in Canada.|Participants were instructed to use glasses as a washout from their habitual contact lens brand for at least seven days prior to initiating the first of three LHE (Low-Humidity Environment) chamber visits. This reporting group consists of all enrolled participants.
734760|NCT01482221|This multicenter study was conducted in Chile, Slovakia, South Africa, and the United States between 16 December 2011 and 26 August 2013. A total of 542 patients were enrolled in the study and of these, 302 patients were randomized to treatment. 240 patients were not randomized to treatment due to eligibility criteria not being fulfilled.|The study had a screening/washout period of up to 42 days, a 12-week double blind treatment period, and a 14-day follow-up period. Patients received 3 infusions per week during Weeks 1 to 3,1 infusion per week during Weeks 4 to 6, and 1 infusion every other week during Weeks 7 to 12.
734761|NCT01482169||
734762|NCT01482091|"Subjects were PRE-CONSENTED for the study in the outpatient hematology clinic, inpatient floors prior to discharge or a separate emergency department (ED) visit prior to discharge. This was done to prevent decision making while under emotional duress of a vaso-occlusive crisis (VOC).
~PRE-CONSENT occurred from 12.12.2011-1.8.2015"|124 subjects were consented for the study. The study drug was only administered one time in the ED if subjects met all inclusion and exclusion criteria when they arrived with a VOC. Only 49 of the 124 consented subjects received the study drug.
734763|NCT01482065||212 subjects screened; 166 subjects were excluded. 40 were included. 39 started in the protocol. 8 patients dropped out. Liver MRI completed in 27 subjects. 12 patients were excluded after liver MRI; 14 subjects had sleep studies. 5 patients did not proceed to the CPAP trial. 9 patients were randomized.
734764|NCT01481935|Rooms in 4 ICUs in a large, urban, academic hospital. Recruitment began on 7/21/2011 and ended on 5/20/2012.|
734765|NCT01481896|For this retrospective study, the Anderson Orthopaedic Research Institute's database was used to identify a consecutive series of the first 126 patients who had 131 primary total hip arthroplasties using a Pinnacle acetabular cup, an Ultamet metal-on-metal insert and a 36-mm cobalt-chrome alloy femoral head.|No patient from the consecutive series of hip replacements performed between April 2001 and November 2002 was excluded.
734766|NCT01481779||
734767|NCT01481740||
734768|NCT01481558|Dates of recruitment: January 2012 to May 2012 Location: Outpatient dementia clinic|
734769|NCT01481376||
734770|NCT01481324||
734771|NCT01481129||
734772|NCT01481116|Participants took part at 291 sites in Argentina, Australia, Bulgaria, Canada, Colombia, Czech Republic, Estonia, Hong Kong, Israel, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Philippines, Poland, Romania, the Russian Federation, South Africa, Taiwan, Ukraine, the United Kingdom and the United States from 06 November 2011 to 24 April 2014.|Participants with a historical diagnosis of type 2 diabetes mellitus who were inadequately controlled while receiving metformin alone were enrolled in 1 of 3 treatment groups as follows: glimepiride; TAK-875 25 milligram (mg); TAK-875 50 mg.
734773|NCT01480843||
734774|NCT01480674|A total of 160 participants were recruited from 28 March 2011 to 16 November 2012.|
734813|NCT01478321|The study opened for accrual on November 14, 2011 with an accrual goal of up to 77 patients and the first patient being enrolled on December 14, 2011. The study was closed permanently on March 24, 2017 due to low accrual with 54 patients treated on the study.|
734814|NCT01478256||
734815|NCT01478113||
734775|NCT01480596|Participants (par.) with myasthenia gravis (MG) and who were acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive, on current standard of care therapy and continued to exhibit signs of MG were eligible for participation in the study.|The study was conducted in 3 phases: a 4 week screening period, a 24 week Treatment (trt) Period, and a 12 week Follow-up period. A total of 40 par. were enrolled, however 1 par. withdrew due to MG exacerbation on Day 7 prior to the first efficacy assessment; therefore, 39 par. comprise the Intent-to-Treat (ITT) Population.
734776|NCT01480297|Recruitment was completed in 3 months time.|
734777|NCT01480284||A total of 166 participants (110 participants in the Tenofovir Disoproxil Fumarate [GSK548470, TDF] group and 56 participants in the Entecavir Hydrate [ETV] group) were enrolled in the study.
734778|NCT01480258|Participants from Italy and Sweden were randomized to Rotavirus Vaccine Subset 1 (Rotarix™). Participants from Finland were randomized to Rotavirus Vaccine Subset 2 (RotaTeq™).|
734779|NCT01480232|Subjects were recruited using advertisements in the local media market.Those who made contact in response to advertisements spoke initially with a research coordinator who provided further information about the study, answered initial questions from the potential subject, and administered a 10-minute questionnaire assessing eligibility.|Prior to initiation of any study procedures, the informed consent process was conducted by a study physician who explained the study in detail making sure that the subject understood the potential risks/benefits as outlined in the consent form; 350 signed consent, 60 were found ineligible and 130 either withdrew consent or was discontinued
734780|NCT01480219||
734781|NCT01480180|The trial was conducted at 77 sites in 22 countries as follows: Australia:3; Brazil:1; Croatia:1; Denmark:2; France:3; Germany:5; Hungary:2; Israel:1; Italy:2; Japan:8; Malaysia:2; Netherlands:2; Norway:1; Russian Federation:1; Korea, Republic of:1; Spain:2; Sweden:1; Switzerland:3; Taiwan:2; Turkey:3; United Kingdom:6; United States:25.|The trial had a main phase and an extension phase 1 and phase 2.
734782|NCT01480089|Women undergoing minimally invasive laparoscopic surgery in urogynecology, benign gynecology, and gynecologic-oncology clinics were recruited. All women who were scheduled to undergo a minimally invasive hysterectomy for benign and cancerous conditions between February 2012 and March 2013 were invited to participate.|One enrolled participant was excluded from the trial before assignment to groups because her physician prescribed Ropivacaine and, consequently, the participant was converted to open label before study drug was assigned or administered.
734783|NCT01480076||
734784|NCT01479985||
734785|NCT01479868||
734786|NCT01479777||
734787|NCT01479764||
734788|NCT01479725||
734789|NCT01479621|"A total of 1903 subjects with asthma were screened for enrollment into this study. Of the 994 subjects who were not enrolled, 983 were excluded on the basis of inclusion/exclusion criteria and 6 subjects withdrew consent, and for 5 the reason given was other."|909 subjects at 188 centers met entry criteria and were considered to be eligible for enrollment into the run-in period of the study.
734790|NCT01479595|Participants were assigned to either QBX258 or placebo in a 2:1 ratio. Randomization was done by stratification of Q576R.|
734791|NCT01479543||
734792|NCT01479530|Outpatients with a primary diagnosis of idiopathic Parkinson's disease.|The study consisted of a 2-week Screening Period during which the levodopa dose was optimised (if required), a 2-week Screening Period during which the levodopa dose was stabilised, a 16-week double-blind treatment period with rasagiline or placebo once daily (patients were randomised in a 1:1 ratio), and a 4-week Safety Follow-up Period.
734793|NCT01479517||
734794|NCT01479478||Only expecting mothers were enrolled in this study. Neonatal data were collected from respective pregnancies, however, the neonates were not considered to be enrolled in this study.
734795|NCT01479465|Participants were enrolled at study sites in the United States, Russia, and Europe. The first participant was screened on 15 December 2011. The last study visit occurred on 27 February 2015.|358 participants were screened.
734796|NCT01479439|This was a multicenter, phase 2, open-label study of losartan for sickle cell nephropathy. Participants were enrolled at nine centers in the United States between 2012 and 2015.|Concomitant treatment with hydroxyurea was allowed, but the dose must have been stable in the 3 months preceding enrollment. Participants were allocated to three pre-specified groups defined by baseline urinary albumin-to-creatinine ratio (UACR).
734797|NCT01479426|Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.|The criteria were an age from 19 to 70 years, IIEF(International Index of Erectile Function)-5 scores ≤ 21 subjects.
734798|NCT01479374|Patients were recruited from three US study centers.|Of the 397 enrolled, 195 subjects did not qualify for treatment and were exited without exposure to product. Participant flow and baseline characteristics are presented for the 202 subjects qualifying for treatment and randomized 1:1:1 to receive AL-4943A, Vehicle, or Pataday.
734799|NCT01479348||No participants were enrolled in the 2/Oral Tetrahydrouridine (THU) Group.
734800|NCT01479270||
734801|NCT01479127||
734802|NCT01479010||
734803|NCT01478971|Participants took part in the study at 5 investigative sites in the United States from 11 October 2011 to 08 February 2013.|Participants with chronic kidney disease and on dialysis continued to receive their standard of care epoetin treatment for 6 months and then transitioned to receive peginesatide injection for 6 months.
734804|NCT01478958|Recruited in three cohorts between November 2009 and June 2012.|
734805|NCT01478854||3 participants were screen failures
734806|NCT01478828||
734807|NCT01478620||
734808|NCT01478594|Participants were at least 18 years of age with Stage IV metastatic colorectal cancer (mCRC) and measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1).|Participants were randomized in a 2:1 ratio (tivozanib to bevacizumab) and stratified by lactate dehydrogenase (LDH) status (< 1.5 x the upper limit of normal [ULN] or > 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or > 2).
734809|NCT01478581||Simon 2-stage design . Stage 1 -13 subjects enrolled in cohort 1. For cohort 2,3, and 4, up to 18 subjects were enrolled in Stage 1. Cohort 4 was selected for expansion for enrollment of 43 subjects in Stage 2.
734810|NCT01478373||39 Patients enrolled. One patient had a protocol deviation which excluded him from the Full Analysis Set.
734816|NCT01478087|First site open to enrollment : November 3, 2011 Study terminated: March 22, 2012|Three (3) subjects enrolled, 2 completed treatment through six-month follow up. One (1) subject terminated participation prior to treatment due to sponsor stopping the study.
734817|NCT01478048||185 participants were enrolled, 152 participants were randomized. Reasons not randomized: 23 no longer met study criteria, 5 withdrew consent, 2 died, 3 had poor/non-compliance. 150 were treated with study drug. 2 participants were not treated: 1 withdrawal by subject and 1 physician decision.
734818|NCT01478009|Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.|The criteria were an age from 30 to 70 years, have contracted at least 2 colds in the past year. Subjects were excluded if they had been vaccinated against influenza in the previous 6 months.
734819|NCT01477892|This noninferiority randomized, double-blind, controlled trial was conducted at the NICU of Seoul National University Children's Hospital and Ajou University Hospital between November 2011 and April 2012|
734820|NCT01477853|Note: 10 participants were enrolled in the study more than once (at more than 1 study site). Nine participants were enrolled twice and one participant was randomized at 3 different sites. Therefore, data of 10 actual participants (counted as 21 participants due to multiple screening/randomization) were removed from the efficacy analyses.|
734821|NCT01477762|Participants were recruited from Grady Memorial Hospital in Atlanta, Georgia.|Of the 165 participants enrolled, 91 met the inclusion criteria and began the study. Sixty three participants completed all study visits for which data were analyzed.
734822|NCT01477749||
734823|NCT01477710|Subjects (registered nurses, respiratory therapists, and physicians) volunteered to participate and signed informed consent documents.|
734824|NCT01477567||
734825|NCT01477463||
734826|NCT01477450||
734827|NCT01477333|The recruitment period for this study was October 2011 to November 2013.|
734828|NCT01477320|Recruitment started in July 2013 in the medical ICU of University of Louisville Hospital. In July 2014, a second recruitment site (medical ICU at Jewish Hospital) was added as a second site for recruitment.|
734829|NCT01477177||
734830|NCT01476748|Recruitment took place in a tertiary hospital, from 12-26-12 to 06-18-13|All enrolled participants were included in the trial
734831|NCT01476722|Subjects were recruited from 5 US study centers.|
734832|NCT01476696||The study was conducted in 2 parts: Part A (single-dose range finding phase) then Part B (once-daily repeated dosing phase). Participants completing Part A could, but were not required to, participate in Part B. There were 2 dosing periods during Part B of the study.
734833|NCT01476644|Moderate glaucoma subjects recruited from the Glaucoma Service at Wills Eye Hospital, Philadelphia, Pennsylvania between May 2012 and May 2014 for an observational longitudinal study. One baseline and four annual visits were performed.|
734834|NCT01476475|The study was conducted at 70 centers in 13 countries. A total of 520 participants were screened between November 21, 2011 and June 08, 2012. Out of 520 participants, 197 were screen failure; main reason for screen failure was that glycosylated hemoglobin (HbA1c) values were out of the protocol defined range.|A total of 323 participants were randomized in 1:1 ratio to insulin glargine/lixisenatide fixed ratio combination (FRC) and insulin glargine arms, stratified by screening HbA1c values (<8% or ≥8%) and screening body mass index (BMI) values (<30 kg/m^2, ≥30 kg/m^2).
734835|NCT01476449||
734836|NCT01476345||This was a randomized, 2-sequence, 4-period, crossover study.
734837|NCT01476267||
734838|NCT01476202|Participants were recruited at the clinical site.|Of 140 screened participants, 120 were randomized while 17 participants were screen failures, and 3 participants were not randomized due to other reasons.
734839|NCT01475955||
734840|NCT01475851||A total of 34 participants (13 participants in the Lamivudine [LAM]/ Tenofovir disoproxil fumarate [TDF] group and 21 participants in the Entecavir [ETV]/TDF group) were enrolled in the study
734841|NCT01475838|Participants were enrolled at study sites in North America and Europe. The first participant was screened on 18 November 2011. The last study visit occurred on 09 December 2014|632 participants were screened.
734842|NCT01475825||
734843|NCT01475734||Eligible participants entered a 1-week Screening Period, a 2-week Run-in/Stabilization Period, a 4-day Treatment Period for the evaluation of efficacy and safety, and an 8-week post-treatment Follow-up Period. A total of 45 participants were screened, 44 were randomized, and 41 completed the study.
734844|NCT01475721|Study duration was 29 weeks, comprised of a randomization visit followed by a treatment period of 26 weeks and a 1 week follow-up phone call. Participants were assessed for eligibility at screening up to 15 days prior to randomization.|Eligible adolescent and adult participants with asthma were stratified based on current asthma medication and a Asthma Control Questionnaire (ACQ-6) score and randomized 1:1 to double-blind study treatment. A total of 11751 were enrolled; however, 72 were randomized but did not receive study treatment.
734845|NCT01475643||
734846|NCT01475513||
734847|NCT01475487||
734848|NCT01475474|Three (3) clinical sites participated in the US pivotal trial, enrolling a total of ninety-seven subjects. The trial consisted of a 4-week baseline evaluation period, a 12-week treatment period and a 4-week return to baseline period. The study started in December 2009 and completed in December 2011.|Renew Medical conducted a multi-center, prospective, open label, single-arm, non-randomized pivotal study designed to establish the safety, effectiveness, and tolerability of the Renew Insert in subjects with moderate-to severe bowel incontinence (defined as having a Wexner score greater than 12).
734849|NCT01475461||Total 615 participants were consented,of which 376 participants entered to run-in period to receive sponsor provided Metformin, 345 participants then randomized to study treatment,of these 335 were treated. Results were collected for 335 participants as data from 1 site (10 participants) were excluded due to major good clinical practice violations.
734850|NCT01475331||
734851|NCT01475305||A total of 90 participants were screened, out of these, 7 participants were randomized and completed the study.
734976|NCT01467999|Participants responded to newspapers, radio and public service announcements in the New York City area, and reported at least 20 days of use in the past 30 days.|
740142|NCT01168219|From July 2010 and October 2013, a total of 68 participants were recruited to this study.|
734852|NCT01475253|Study subjects were recruited by clinical centers that saw subjects meeting eligibility criteria and were capable of undergoing cystoscopy per protocol specifications. The first subject was enrolled 28 November 2011.|In addition to meeting all protocol defined inclusion/exclusion criteria, participants were required to be females with a confirmed diagnosis of moderate to severe Interstitial Cystitis (IC) according to the 1987 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) symptom severity criteria (modified to exclude cystometry).
734853|NCT01475214||
734854|NCT01475175|Twelve subjects were enrolled at six centers in Europe between November 2011 and March 2012.|
734855|NCT01475162||
734856|NCT01475097|255 subjects were enrolled in this study. Two (2) subjects did not complete the study. Total number of subjects that completed the study was 253.|Total of 255 subjects enrolled in this study. 2 subjects discontinued the study prior to contrast administration. Therefore, 253 subjects completed the study.
734857|NCT01475071|100 subjects recruited from March 2012 to May 2012 in private practice and clinic.|No significant events
734858|NCT01474993|Forty-four study participants were initially enrolled in the study from January 2011 to July 2013 at Lurie Center for Autism.|
734859|NCT01474915|Recruitment was conducted at The Ohio State University Wexner Medical Center. It started in January of 2009 and ended in April of 2012.|Whenever a participant was enrolled into the study but later did not meet all the inclusion/exclusion criteria, they were excluded from the trial before assignment to groups.
734860|NCT01474876||A total of 566 participants were enrolled, and 11 participants were lost to follow-up after the baseline visit. According to the pre-specified analysis strategy in the statistical analysis plan, these participants were excluded from the full analysis set, which consisted of 555 participants.
734861|NCT01474863||
734862|NCT01474772|411 participants were screened, of whom 206 were withdrawn before randomization. 205 were randomized, of whom 2 discontinued before being treated. Participants were randomized at 36 centers in 4 countries: US (25), Sweden (4), South Africa (4), and Czech Republic (3). 11 centers received study drug but did not randomize participants.|Participants completed daily pain and sleep diary from Visit 1 (V1; Screening) to Visit 12 (V12; Follow-up). Participants with a mean pain score ≥ 4 (moderate to severe pain) and those meeting the pain on walking criteria (post-walk pain score ≥ 4, and > the pre-walk pain score at V1 and Visit 2 [V2; Baseline]) were randomized.
734863|NCT01474746||
734864|NCT01474681|Single arm study of HSC835 broken down into 4 subgroups for analyses and 6 subgroups for safety.|
734865|NCT01474590||
734866|NCT01474551|Protocol Open to Accrual: 11/15/2011 Protocol Closed to Accrual: 03/12/2013 Primary Completion Date (if applicable): 03/12/2013 Recruitment Location is the medical clinic|
734867|NCT01474538||
734868|NCT01474512|Induction Period (Week 0 to 12), Maintenance Period (Week 12 to 60); Long term Extension (Week 60 to 264) and Post treatment ( last treatment visit (week 264), or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.|Participants received Ixekizumab (ixe) as responders (Resp, sPGA 0/1) in Induction (IND) re-randomized to receive ixe Q4W, Q12W or placebo (PBO) in Maintenance (MAIN) [Primary Population (Pop)]. In MAIN, non-responders (Non-Resp, sPGA >1) in IND received ixe Q4W, PBO Resp in IND received PBO (Secondary Pop). Ixe or PBO continued to end of study.
734869|NCT01474434|Study was terminated upon Part A interim analysis. Total 41 patients randomized to Part A i.e.17 patients in cohort 1 and 24 patients in Cohort 2.|
734870|NCT01474317||
734871|NCT01474291||Participants were not allocated to study arms but were separated according to therapy regimen post hoc for efficacy and safety analyses. Of the 608 participants enrolled 5 were not eligible for analysis (1 was found to be duplicate and 4 did not receive tocilizumab infusion).
734872|NCT01474239||Study included 28-day screening period. Participants were randomized according to a 2:1 ratio to one of the 2 treatment groups. A total of 99 participants were screened, of which 91 were randomized.
734873|NCT01474213|Forty two adult patients, American Society of Anesthesiologist (ASA) score of I-III, were recruited for an elective awake fibreoptic nasotracheal intubation due to the diagnosis of maxillofacial cancer or fracture with limited mouth opening|One patient declined consent and one operation was cancelled.
734874|NCT01474200||
734875|NCT01474122|Conducted at 73 centers in 20 countries.The first patient randomized was 9 Feb 2012 and last patient, last visit was 6 Feb 2014.|A screening visit was performed between Day -14 and Day -1 of the study. Of the 324 patients screened for the study, 59 were screen failures.
734876|NCT01474109|Conducted at 70 centers in 17 countries. First patient randomized was 11 January 2012 and last patient, last visit was 29 November 2013.|A screening visit was performed between Day -14 and Day -1 of the study. Of the 327 patients screened for the study, 38 were screen failures.
734877|NCT01474018||
734878|NCT01473992||
734879|NCT01473953|The trial was conducted at one site in Evansville, Indiana, USA.|It was a Novo Nordisk business decision, and not a decision due to safety concerns, not to continue the development of liraglutide depot. Therefore cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done. So no subjects were enrolled for the outcome measure 6.
734880|NCT01473940|The study opened at our site April 3, 2012 with the first patient being enrolled and starting treatment on June 11, 2012. The study was designed to with 4 dose escalation cohorts to determine maximum tolerated dose (MTD) and then an expansion cohort at the MTD. The study closed March 23, 2016 with a total of 21 patients treated on the study.|
734881|NCT01473836||
734882|NCT01473758|Participants took part in the study at 1 investigative site in the United Kingdom from 16 February 2012 to 25 March 2014.|Participants with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) were enrolled equally in 1 of 2 treatment groups, once a day placebo or roflumilast 500 µg in Cycle 1. Participants were re-randomized in Cycle 2 to once a day placebo or roflumilast 500 µg and are counted as new participants.
734972|NCT01468207|Participants ≥ 18 years of age with HS for at least 1 year prior to Baseline and HS lesions present in at least 2 distinct anatomical areas (one of which must be at least Hurley Stage II or III) who had experienced inadequate response to ≥ 90 day treatment of oral antibiotics for HS were eligible for enrolment in the study.|
734973|NCT01468181||
734974|NCT01468077||
734975|NCT01468012||
734883|NCT01473745|All nongrowing Taiwanese patients over 18 years of age who underwent LeFort I maxillary osteotomy to correct skeletal discrepancies were randomly selected to receive either conventional or modified alar base cinching during the intraoral wound closing procedure.The recruitment duration was September of 2011 to February of 2013.|Exclusion criteria: Patients with an associated syndromic diagnosis, cleft of the lip or palate, dentofacial trauma, and previous nasal septum or nasal tip operations. 10 non-Class III patients were further excluded for enhanced sample consistency, 2 patients refused to participate were also excluded. Thus, total sample size was 48 patients.
734884|NCT01473732||
734885|NCT01473602||
734886|NCT01473589||
734887|NCT01473563||Participants who completed study treatment and follow-up (FU) were considered to have completed the study. Participants received treatment until disease progression or discontinuation and were followed post treatment (post tx) discontinuation for up to 6 months.
734888|NCT01473524|Recruitment into hospitals and physicians' clinics started January 2012 and completed December 2012.|"Screening interim allowed for pre-randomization eligibility assessment of 1 to 8 weeks.
~A total of 217 participants were randomized into the double-blind phase of the study, however, 216 received treatment with study drug. One randomized participant discontinued prior to receiving any study drug."
734889|NCT01473420|Participants with chronic renal failure were receiving Epoetin maintenance therapy prior to enrollment and treatment in this study.|
734890|NCT01473407|Participants with chronic renal failure were receiving Epoetin maintenance therapy prior to enrollment and treatment in this study.|
734891|NCT01473394||
734892|NCT01473381||
734893|NCT01473368||
734894|NCT01473355||
734895|NCT01473160|Participants were recruited from one study center in the UK.|
734896|NCT01472965|Participants meeting eligibility criteria were enrolled between December 2011 and August 2016. They were randomized to receive catheter lock therapy using either 70% ethanol or heparin-saline (placebo). Randomization was blinded to the participant, their care provider, the investigator, and the outcomes assessor.|
734897|NCT01472939||
734898|NCT01472874||
734899|NCT01472835||
734900|NCT01472822|Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.|The criteria were an age from 30 to 70 years, mild to Moderate KO as indicated by WOMAC(Western Ontario and McMaster Universities Arthritis Index) score ≥ 38 subjects.
734901|NCT01472757||374 subjects were randomised, and 373 received at least one dose of study drug; 1 subject was randomised but not treated.
734902|NCT01472718||
734903|NCT01472692||The Principal Investigator for this study has passed away and the results data is not available.
734904|NCT01472562||
734905|NCT01472549|In this single-center, randomized, controlled trial, a total of 1147 patients were enrolled from September 2011 through June 2015.|
734906|NCT01472445||
734907|NCT01472432|Completed|
734908|NCT01472380|Thirty (30) healthy, non-smoking adult male and female volunteers from the community at-large were enrolled|
734909|NCT01472341|This observational study was conducted at 9 outpatient diabetes clinics in Italy.|
734910|NCT01472289||
734911|NCT01472185|Participants were enrolled at a total of 113 study sites in the United States, South Africa, Europe, and Russia. The first participant was screened on 15 November 2011. The last participant observation occurred on 21 October 2013.|605 participants entered the qualifying period; 465 were randomized, and 464 were randomized and treated (Safety Analysis Set). Of these, 8 were excluded due to major eligibility criteria protocol violation or had baseline but no on-treatment data; thus, 456 were included in the Full Analysis Set.
734912|NCT01472081||194 participants were enrolled; 153 were treated. Participants were enrolled but not treated due to the following reasons: withdrawal of consent (n=5), no longer met study criteria (n=32), administrative reason by sponsor (n=1), or other reasons (n=3)
734913|NCT01471782|The study was conducted in 26 centers in Germany, France, Italy, the Netherlands, the United Kingdom, and the United States of America. Results are reported for the primary analysis with a data cut-off date of 12 January 2015.|"The Phase 1 part of the study comprised 2 parts:
~a dose evaluation/escalation part in patients aged 2 to 17 years to define the recommended phase 2 dose of blinatumomab (4 arms),
~a pharmacokinetic (PK) expansion part in patients less than 18 years.
~The Phase 2 efficacy part enrolled patients at the recommended dose determined in phase 1."
734914|NCT01471691||
734915|NCT01471379|The subjects were recruited from community using University of North Carolina (UNC) mass email system, newspaper advertisement and UNC gastrointestinal (GI) clinic referral.|Subjects undergo screening labs and questionnaires to make sure subjects are healthy and don't have any underlying conditions. Subjects who had clinically significant labs or Hospital Anxiety and depression scale(HADS)score more than 17 were excluded.
734916|NCT01471353||43 Patients were consented and enrolled; however, only 42 were dosed. The one patient that was not dosed was removed due to progression of disease prior to treatment initiation.
734917|NCT01471340|11,744 participants were enrolled in the study and 11,729 participants were randomized and received at least one dose of blinded study treatment (defined as the number started). Treatments were Mometasone Furoate/Formoterol (MF/F) metered dose inhaler (MDI) twice daily (BID) and Mometasone Furoate (MF) MDI BID.|
734918|NCT01471639|December 01, 2011 Emergency Department|Chronic pain, critical illness
734919|NCT01471626|Recruitment took place in the Sleep Lab of a tertiary hospital. Patients were recruted for ploysomnography if they were clinically suspicted of OSA.|
734920|NCT01471574|The study was conducted at 84 sites in 13 countries.|Of 549 participants enrolled, 301 were randomized to receive treatment. Of the 248 participants who were not randomized, 204 no longer met study criteria, and 44 discontinued due to other reasons.
734921|NCT01471522||
734922|NCT01471457||
734923|NCT01471197|Study started July 2012 and completed February 2013. After 9 participants enrolled, the study was terminated for administrative reasons unrelated to adverse events (AEs) or expectation of efficacy associated with either ipilimumab or pemetrexed.|9 participants enrolled; 8 participants randomized; 1 participant not randomized due to disease progression and death.
735004|NCT01466491||
734924|NCT01471171|This study was conducted at 16 enrolling sites. A total of 14 sites randomised patients: 10 sites in Germany, 3 sites in Spain and one site in the United Kingdom. The first patient was screened in November 2011 and the last patient visit was in June 2012.|Eligible patients entered a 14-21 day run-in period to assess disease stability. During this period, one site visit was performed to familiarise patients with study testing procedures (body plethysmography, spirometry and a constant work rate cycle exercise test).
734925|NCT01471054||
734926|NCT01471041||
734927|NCT01471028||
734928|NCT01471015||
734929|NCT01470859||
734930|NCT01470781||
734931|NCT01470651||
734932|NCT01470599|This study was conducted in participants who completed the 26-week maintenance treatment of Study A3921084 or who withdrew early due to A3921084 study treatment failure according to prespecified criteria.|Participants were assigned to either the 5 milligram (mg) twice daily (BID) or 10 mg BID treatment group according to clinical remission status as assessed by Crohn's Disease Activity Index (CDAI) score at the end of the A3921084 study treatment visit or early termination visit due to A3921084 study treatment failure.
734933|NCT01470469||
734934|NCT01470417||
734935|NCT01470326||
734936|NCT01470248|All patients were enrolled through the thoracic medical oncology clinic of the Winship Cancer Institute of Emory University, between August 2011 and April 2014.|
734937|NCT01470196||
734938|NCT01470170||
734939|NCT01470144|Extension study for patients who completed EPITOME-2 (AC-066A301). Patients continued to receive EFI (epoprostenol sodium). In 6 countries (FR, CA, BE, NL, IT, ES) at 8 expert centers for the treatment of patients with pulmonary arterial hypertension. Recruitment started on 15 June 2011 and was completed on 02 February 2012.|
734940|NCT01470118||
734941|NCT01470027|Enrollment for this pilot clinical study started in March 2012, as the end of the study in August 2016, 23 of 30 PD patients and 27 of 30 healthy volunteers (HV) subjects - a total 50- had participated in the study. All subjects enrolled at the Weill Cornell Parkinson's Disease and Movement Disorders Institute, led by the study neurologist.|A total of 50 subjects enrolled into the study (23 PD patients and 27 HV subjects). Only 21 patients with PD and 26 HV subjects underwent the baseline assessments. Two PD patients and 1 HV subject were excluded from the study before assignment to groups. All exclusion were unrelated to the study protocol.
734942|NCT01470001||
734943|NCT01469819|Participants recruited from University of Kansas Medical Center, in Kansas City, KS from July 2008 to August 2009. Additional participants were recruited from Texas Tech University Health Sciences Center - El Paso, in El Paso, TX between April 2012 and November 2012.|37 participants recruited; 37 screened, 8 excluded. 25 of those subjects participated in small intestinal bacterial overgrowth (SIBO) testing and analysis.
734944|NCT01469767||
734945|NCT01469715||
734946|NCT01469637||
734947|NCT01469585||
734948|NCT01469546||42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed..
734949|NCT01469377||
734950|NCT01469364|Subjects were recruited from two lung transplant centers, Duke and UCLA, and 30 subjects enrolled in the study from April 2013 to July 2014.|
734951|NCT01469234||
734952|NCT01469221||Patients 1) meeting Open Label Phase and Double Blind Phase inclusion and exclusion criteria, including confirmed histology based on Central Pathology Review, and 2) has eligibility packet approved by Sponsor, are randomized in a 1:1 fashion to receive 6 weekly instillations of apaziquone or matching placebo.
734953|NCT01469182||
734954|NCT01469065||
734955|NCT01469052||
734956|NCT01469039|Included subjects with schizophrenia experiencing an acute exacerbation episode.|Subjects were admitted to an inpatient study unit. Currently prescribed antipsychotics were discontinued prior to administration of study drug. One randomized subject was discontinued for a protocol violation prior to receiving investigational treatment.
734957|NCT01469013||Participants on background methotrexate therapy were assigned to a dose of 1, 2, 4, 8 mg baricitinib (LY3009104) or placebo capsule once daily in a double blind manner for 12 weeks followed by single blind treatment of 4 mg or 8 mg baricitinib (LY3009104) tablet once daily for 52 weeks extension period.
734958|NCT01469000||Participants who were alive and completed the follow-up period or who died were considered to have completed the study.
734959|NCT01468987||
734960|NCT01468974|A total of 35 subjects registered in this study were implanted with the ESPRIT BVS at 7 centers in 4 countries (Belgium, France, Germany and Austria) across Europe. First subject was registered in the ESPRIT I Clinical Investigation on December 20, 2011. The last subject was registered on August 28, 2012.|
734961|NCT01468909|106 patients were enrolled between December 2011 and April 2013.|
734962|NCT01468896||
734963|NCT01468818||
734964|NCT01468675||
734965|NCT01468597||"184 patients were screened for eligibility. Of these, 17 patients were found to be ineligible for the study.
~Therefore the number of actually enrolled patients is 167."
734966|NCT01468584||
734967|NCT01468558||All subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg Intravenous (IV) Dihydroergotamine Mesylate (DHE).
734968|NCT01468350||Part A, 11 subjects enrolled and randomized. 6 subjects randomized into Sequence BA (placebo - dalfampridine-ER) and 5 randomized into Sequence AB (dalfampridine-ER - placebo). Part B, 24 subjects enrolled and randomized. 12 subjects randomized into Sequence BA (placebo - dalfampridine-ER) and 12 into Sequence AB (dalfampridine-ER - placebo).
734969|NCT01468337||
734970|NCT01468311||
734971|NCT01468233|Participants ≥ 18 years of age with HS for at least 1 year prior to Baseline and HS lesions present in at least 2 distinct anatomical areas (one of which must be at least Hurley Stage II or III) who had experienced inadequate response to ≥ 90 day treatment of oral antibiotics for HS were eligible for enrolment in the study.|
740143|NCT01168024||
740144|NCT01167907||
734977|NCT01467960|90 healthy subjects are enrolled on the base of their age being classified in the groups I (20-40), II (40-65) and three (>than 65). 90 patients are enrolled on the base of their disease's stage (Hoehn and Yahr classification) being classified in the groups A (I, H&Y), B (II, H&Y) and C (> than II, H&Y).|
734978|NCT01467947||60 subjects were screened and enrolled in the study. 14 subjects did not experience an HAE attack before the study ended and so did not receive study treatment. 46 subjects started and completed the active treatment period of the study.
734979|NCT01467934||
734980|NCT01467882|Intention to treat, defined as all participants enrolled|
734981|NCT01467713|Participants took part in the study at 100 investigative sites in Argentina, Chile, Colombia, Mexico and the United States from 21 December 2011 (first participants signed the informed consent form) to 26 March 2015.|Participants with a diagnosis of bipolar disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, Tak-375 SL (ramelteon) 0.1 mg, 0.4 mg or 0.8 mg.
734982|NCT01467700|Participants took part in the study at 98 investigative sites in Argentina, Chile, Colombia, Mexico and the United States 12 December 2011 (first participant signed the informed consent form) to 10 March 2015.|Participants with a diagnosis of acute depressive episode were enrolled equally in 1 of 4 treatment groups, once a day placebo, ramelteon [TAK-375 SL (sublingual)] 0.1 mg, 0.4 mg or 0.8 mg.
734983|NCT01467661|The study was conducted in 15 centers in the Japan between 27 October 2010 and 01 May 2015.|Overall 53 participants were enrolled in study SPD422-308 (NCT01214915), 42 of them completed the study. Of these 42 participants, 41 entered in to the current extension study SPD422-309 (NCT01467661) with 33 of 41 participants entered the post marketing trial and 32 participants completed the study (after marketing approval was granted).
734984|NCT01467583||
734985|NCT01467570|This was a double blind, randomized controlled trial carried out in the emergency departments of 2 pediatric hospitals in Poland (The Medical University of Warsaw and St Hedvig of Silesia Hospital, Trzebnica).|Of the 147 children who underwent randomization, 72 were assigned to the experimental group and 75 were assigned to the control group. 17 children discontinued the study and eventually were lost to follow-up. The reason for lost to follow-up: parents refusal (N=2), not attend to scheduled visit (N=12), diarry lost (N=2), randomization error (N=1).
734986|NCT01467557||
734987|NCT01467505|Study included Treatment-Naïve (no prior hepatitis C virus [HCV] therapy); Prior Relapser (prior treatment with pegylated interferon alfa/ribavirin [Peg-IFN/RBV] and experienced viral relapse); Prior Null/Partial Responder (prior treatment with Peg-IFN/RBV and had null/partial response); Uncategorized (could not tolerate treatment) participants.|Efficacy analyses were reported separately as per immunosuppressant regimen (reporting arms) and also separately as per prior response (in categories) (Treatment-Naive, Prior Relapser, Prior Null Responder, Prior Partial Responder, Uncategorized as well as for Total Participants), unless otherwise specified.
734988|NCT01467492|Study included Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin [Peg-IFN/RBV] and experienced viral relapse) and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.|Efficacy analyses were reported as per Race (Black/Non-Black) (reporting arms) and also separately as per prior response (in categories) (Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.
734989|NCT01467479|Study included Treatment-Naïve (no prior hepatitis C virus [HCV] therapy); Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin [Peg-IFN/RBV] and experienced viral relapse); and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.|Efficacy analyses were reported as per highly active antiretroviral therapy (HAART) treatment (reporting arms) and also separately as per prior response (in categories) (Treatment-Naive, Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.
734990|NCT01467466||
734991|NCT01467427|Of the 19 sites that screened subjects, 17 sites enrolled subjects. The trial was therefore conducted at 17 sites in 8 countries, as follows: Canada: 1 site; Germany: 1 site; Italy: 1 site; Japan: 3 sites; Malaysia: 1 site; Taiwan: 1 site; United Kingdom: 3 sites; United States: 6 sites|
734992|NCT01467271||
734993|NCT01467076|Opened for recruitment on 10/20/2011. There was a lag of 33 to 90 days between IRB approval and site readiness to enroll patients. 46 infants were screened at 8 sites, 14 met eligibility criteria, and 7 were randomized. Enrollment was halted for lack of feasibility in mid-May 2012; at that time, only 7 patients had been enrolled.|Seven eligible infants were not enrolled because parents were unavailable or refused consent for 3 of the infants, 3 infants met ECMO criteria, and 1 had cardio-respiratory arrest.
734994|NCT01467037|We conducted prospective, active surveillance for acute rotavirus gastroenteritis at The Montreal Children's Hospital and Centre Hospitalier Universitaire Sainte-Justine, located in Montreal, and Centre Hospitalier Universitaire de Sherbrooke, located in Sherbrooke.|
734995|NCT01466985|Participants with human immunodeficiency virus type 1 (HIV-1) who were antiretroviral therapy (ART)-naïve were enrolled at a single study center in Germany.|Participants were allocated into panels, then randomized to doravirine 25 mg or placebo (Panel A) or doravirine 200 mg or placebo (Panel B). The protocol planned for a possible Panel C but Panel C was not enrolled. Study results are presented according to actual treatment received.
734996|NCT01466972||
734997|NCT01466881||
734998|NCT01466790||A total of 168 participants enrolled to study. 1 participant who was randomized to Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks group, but never received treatment.
734999|NCT01466764||13 were enrolled and 3 participants withdrew prior to randomization
735000|NCT01466751||
735001|NCT01466673||
735002|NCT01466660|"Two-arm, randomised (1:1 ratio), open-label, parallel group trial.
~In the study disease response was assessed by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1."|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
735003|NCT01466595|A5286 opened under version 2.0 on 09/01/11, and the first subject was randomized on 10/03/11. Accrual to the study closed on 07/30/12, with a total of 73 subjects enrolled from 32 sites within the US.|Subjects were randomized with a 2:1 ratio (Rifaximin : no study treatment) at enrollment.
735005|NCT01466387|Subjects were enrolled at 5 sites (Berhard Nocht Institut, Germany, Berliner Centrum fuer Reise, Germany, Universitat Rostock, Germany, University of Munich, Germany, Vacc and Travel Med. Center, Czech Republic)|All enrolled subjects were included in the trial.
735006|NCT01466361|Participants were recruited at the clinical site.|Participants who smoked more than 5 cigarettes per day were included in the study. Participants were stratified to treatments according to their smoking status: heavy smokers: smoking greater than 20 cigarettes per day and light smokers: smoking between 6 - 20 cigarettes per day.
735007|NCT01466348|Participants were recruited at the clinical site.|A total of 75 participants were screened, and 72 were randomized. 3 participants did not meet the study criterion. A 5 hour washout period was maintained between treatment periods.
735008|NCT01466270|Patients were accrued between 7/12 and 1/13 from CCOP sites across the nation.|No wash-out or run-in period. All enrolled patients were randomized.
735009|NCT01466192||
735010|NCT01466179|"This study was open to adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia (ALL).
~The study protocol originally used a Simon 2-stage design and was subsequently expanded to include a third stage. Protocol amendment 4 added an additional cohort of participants for central nervous system evaluations."|Two hundred twenty-five participants enrolled in the study overall. Results below include data for 189 participants enrolled in the first 3 stages of the study (the primary analysis set). An additional 36 participants enrolled in the Additional Evaluation Cohort are not reported here as the study is ongoing and data collection has not completed.
735011|NCT01466166|A total of 249 patients were screened at 66 of 112 activated clinical sites in the United States; 61 (24.5%) of the 249 patients were screen failures and 188 were enrolled.|
735012|NCT01466153||A total of 182 participants were screened and 159 participants were randomized.
735013|NCT01466127||
735014|NCT01466075||
735015|NCT01466062||
735016|NCT01465997|Enrollment started in May 2012 and concluded in January 2017 - 551 patients. Due to the political and civil unrest in Luhansk PAREXEL was not able to conduct further site visits to one site in Ukraine and to collect further data for 2 subjects,they were excluded from SP0994, leaving 549 patients in the Enrolled Set out of 551 initially enrolled.|"A total of 549 subjects gave informed consent in SP0994 and were included in the Enrolled Set, 548 subjects received at least 1 dose of study medication and were included in the Safety Set (SS).
~Participant Flow refers to the Safety Population including all enrolled subjects who received at least 1 dose of study medication in the current study."
735017|NCT01465958|A total of 13 subjects were screened for participation in this study. After screening, one subject discontinued the study and did not receive study drug. Eleven subjects entered the Run-in phase. One subject entered intravenous Gamunex-C phase directly. A total of 11 subjects entered the IV phase and subsequently entered the SC phase.|
735018|NCT01465841||
735019|NCT01465802||
735020|NCT01465763||Participants were randomized to tofacitinib 10 milligram (mg) or placebo twice a day (BID)(4:1 ratio) after protocol amendment 3, which removed tofacitinib 15 mg BID. Due to low participant numbers, tofacitinib 15 mg BID was excluded from efficacy analyses, but was included in participant flow, baseline characteristics and adverse events analyses.
735021|NCT01465659|The study was opened to enrollment on November 15th 2011 with the first patient starting treatment December 12th 2011. The study was designed to enroll up to 40 patients with a phase I dose escalation portion and a phase II expansion portion at the determined dose. The study was closed to further enrollment February 27 2019.|
735022|NCT01465464||
735023|NCT01465412||
735024|NCT01465386||
735025|NCT01465347|Treatment naive patients with a histologically confirmed diagnosis of GBM who were scheduled to receive standard-of-care radiation and temozolomide treatment per Stupp et al (2005) were enrolled in the study at 18 academic clinical sites in the U.S.|Open-label, historical control (Stupp et al; N Engl J Med 2005; 352: 987-996, March 10, 2005, DOI: 10.1056/NEJMoa043330); patients received standard-of-care radiation/temozolomide treatment plus Trans Sodium Crocetinate (TSC); three (3) patients completed 9 doses (phase 1) as a safety run-in followed by 56 patients who received 18 doses (phase 2).
735026|NCT01465334|Participants enrolled between December 2011 and November 2014.|
735027|NCT01465230||
735028|NCT01465191||
735029|NCT01465178|Enrollment started December 2011 and ended December 2014. Subjects were enrolled from the community and research was conducted at the University of Wisconsin Osteoporosis Clinical Research Program.|No adverse events were reported between screening and randomization. All screened volunteers that were not enrolled in the study were deemed ineligible based on 25(OH)vitamin D being outside the study entry criterion.
735030|NCT01465048||
735031|NCT01465022|The study design is double-blind randomized controlled trial in which postpartum women who have decided to breastfeed and who choose birth control pills as their contraceptive method are randomized to one of two groups:|The research nurse recruiting the eligible subject will ask the subject if they have been given adequate time to make a decision regarding study participation.
735032|NCT01464996||Twenty six participants were screened and satisfied inclusion criteria, but only 24 were enrolled.
735033|NCT01464931||
735034|NCT01464879|The study was conducted at one study site in the US. Out of 78 subjects screened, 20 subjects were enrolled in the study.|Apart from having history of hypogonadism, the study subjects were required to present with one or more symptoms of testosterone deficiency (i.e. fatigue, decreased muscle mass, reduced libido, reduced sexual functioning of a non-mechanical nature). The study subjects needed to be in good health despite exhibiting hypogonadism.
735035|NCT01464840|Patients were recruited from the prenatal clinic from May 2012 to May 2013.|
735036|NCT01464827|This was a Phase 2, open-label, randomized, combination treatment study of multiple doses of ABT-450/ritonavir, and ABT-267 and/or ABT-333 with or without ribavirin in hepatitis C virus (HCV) genotype 1-infected treatment-naïve patients and previous null responders to pegylated interferon (pegIFN) and ribavirin treatment.|
735121|NCT01460225|19 patients entered the study; no dropouts. All patients completed the study; the entire study was contacted at Dartmouth.|No patients were excluded.
735122|NCT01460160||A total of 109 participants were enrolled and 106 participants were treated with dasatinib (82 participants received dasatinib in the tablet form exclusively and 24 participants received either tablet and/or PFOS).
735037|NCT01464788|Patients who have had an ischemic stroke and admitted to the Accident and Emergency Department or Acute Stroke Unit by their treating physician receive IV Recombinant tissue plasminogen activator as per standard treatment, provided they are able to be treated within 4.5 hours of the onset of their stroke symptoms.|Patients who met the inclusion criteria received a head CT scan prior to initiation of rt-PA and the Argatroban infusion. If available, patients also underwent intracranial vessel imaging performed before or immediately after IV-tPA bolus (but before Argatroban bolus). Patients could not be randomized until after the CTA demonstrated an occlusion.
735038|NCT01464775||
735039|NCT01464723||The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.
735040|NCT01464697||Enrollment required meeting eligibility criteria by screening questionnaire but also required eligible hot flushes and night sweats on a 28-day Calendar. The difference between the listed enrolled and those who were randomized represents this fact.
735041|NCT01464619||
735042|NCT01464424|Subjects were recruited from 2 study centers located in the US.|This reporting group includes all enrolled subjects. A washout-period based on prior medication preceded Period 1 dispense.
735043|NCT01464359||
735044|NCT01464346||
735045|NCT01464333||"Of the 511 patients enrolled, case report forms were not collected from 7 patients (N = 504). The safety analysis set excluded 115 enrolled patients due to safety assessment impossible (N = 389). The efficacy analysis set excluded 79 patients that were included in the safety analysis set due to efficacy assessment impossible (N = 310)."
735046|NCT01464307|A total of 331 individuals suffering from post-stroke lower-limb spasticity were screened and 290 were included in study at 51 sites. One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication. For purpose of study analysis overall number of subjects enrolled is therefore considered 289.|A total of 290 subjects were enrolled in study. One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication. A total of 289 subjects were enrolled in main period. All of the 269 subjects who completed the main period of the study entered the open-label extension period.
735047|NCT01464255|A total of 71 subjects were recruited for the study, with 21 subjects being disqualified at the initial screening for a total of 50 subjects started.|Fifty subjects started. Forty-nine subjects completed the study. One subject was disqualified after one week of wear of the control lens (ocufilcon B) during the 1st week of the study due to unresolved corneal staining.
735048|NCT01464229||
735049|NCT01464190||
735050|NCT01464021||
735051|NCT01463982||
735052|NCT01463878|18 patients were consented and only 14 enrolled. 4 dropped out as failed to meet the inclusion criteria after consent; were bale to take food by mouth|
735053|NCT01463696||
735054|NCT01463683||
735055|NCT01463631||For cohorts 1-3, participants completed the trial if they received at least 75% of planned doses of LY3007113 and completed at least 1 cycle. For Part B, participants completed the trial if they completed at least 2 cycles of study treatment and were assessed for response. (Cycle = 28 days.)
735056|NCT01463527||
735057|NCT01463384|Patients were recruited from local physicians, through Clinical Trials website and the AD association.|
735058|NCT01463306||Reporting arms are on basis of pediatric and adult participants who consented to continue from previous studies receiving either pregabalin or placebo and pediatric participants who directly enrolled in this study. Previous studies- A0081041 (NCT01389596), A0081042 (NCT02072824), A0081105 (NCT01747915).
735059|NCT01463293||
735060|NCT01463267||
735061|NCT01463202||Since participants could be recruited antepartum but may have changed their mind about breastfeeding or DMPA use post-partum, eligibility criteria were re-assessed postpartum, prior to randomization, thus the number of women enrolled in the study (184) does not equal the number of women randomized (157).
735062|NCT01463111|Participants were recruited from May 2011 through April 2016.|Of the 37 participants who consented for participation, 26 began study treatment. Eleven participants were screen failures.
735063|NCT01463098|Participants took part in the study at 2 investigative sites in United States from 05 October 2011 to 11 August 2012.|"Part A: A total of 160 healthy participants were screened, of which 96 were screen failures and 64 were enrolled and randomized to receive study treatment.
~Part B: A total of 281 otherwise healthy participants with primary insomnia were screened, of which 223 were screen failures and 58 were enrolled and randomized to receive study treatment."
735064|NCT01463033||
735065|NCT01463007||40 patients must COMPLETE treatment. 41 were registered because 1 was removed secondary to Physician decision to not continue treatment.
735066|NCT01462942|The study was conducted in 22 countries (Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, the Netherlands, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Ukraine and UK). The first patient was screened in October 2011 and the last patient visit was in January 2013|In total, 2443 patients were screened, of whom 1729 were considered eligible and were randomized into the study. 714/2443 patients were not randomized due to screening failure (primarily for non-fulfillment of inclusion/exclusion criteria)
735067|NCT01462929|This study was conducted in 49 sites investigators in 4 countries (3 sites in the Czech Republic, 23 in Germany, 8 in Hungary and 15 in Poland). 8 sites (3 in Germany, 3 in Hungary and 2 in Poland) did not randomise any patients. The first patient was screened in Oct 2011 and the last patient visit was in Mar 2012.|Patients fulfilling inclusion/exclusion criteria at the time of the screening visit were entered into a run-in period of 14-21 days to assess disease stability.
735068|NCT01462877|Dyslipidemic Chinese patients with CHD or CHD equivalent, whose TG ≥1.70 mmol/L and <5.65mmol/L after at least 2 month statin monotherapy with standard dose were enrolled. After at least 2 month statin monotherapy with standard dose, patients having high TG were recruited and given statin-fenofibrate combination therapy for 8 weeks.|
735069|NCT01462812|private practices and research clinics|Screening period (general medical exams, labs, medical and headache history, concomitant medications.
735070|NCT01462773||
735071|NCT01462695||
735072|NCT01462565|A total of 17 participants were recruited from 23 November 2011 to 16 May 2012, out of which 16 participants entered the treatment phase. Study was conducted across 5 centres in the United States, 1 centre in Canada and 1 centre in the Netherlands.|There was a 4-week run-in period during which 1 participant was assessed to be a screen failure at the Baseline Visit (Visit 2) due to the participant self-titrating their epoprostenol sodium. During the 4-week run-in period, participants received currently marketed epoprostenol sodium.
735073|NCT01462435||
735074|NCT01462370||
735075|NCT01462357||1079 subjects entered this study, of which 4 subjects signed an informed consent but did not receive a single dose of the vaccine and were hence not counted as starting the study.
735076|NCT01462344|A total of 6250 participants were enrolled and randomized to study treatments; total 6208 participants took at least one dose of study drug.|Participants aged between 4 to 11 years having asthma, defined by the regional asthma guidelines for at least 6 months, having history of at least one occurrence of treatment with systemic corticosteroid and with no change in asthma therapy for the last 4 weeks from first visit were enrolled for the study.
735077|NCT01462318||
735078|NCT01462305||Subjects in this multicenter trial were recruited and treated at one of five participating sites between January and March 2012. Fifty-six subjects were recruited from 5 health care centers. Twenty-one failed to meet all the inclusion/exclusion criteria, including depression severity and were not randomized into the study.
735079|NCT01462292|A total of 51 male participants, with Duchenne Muscular Dystrophy were randomized in the study. The study was conducted from 26 October 2011 to 04 November 2013.|
735080|NCT01462279||
735081|NCT01462266||
735082|NCT01462253||
735083|NCT01462227||
735084|NCT01462162|Total of 122 participants were recruited, 2 participants were excluded from analysis, one due to non-compliance with the inclusion criteria and other due to compliance with the exclusion criteria.|
735085|NCT01462110||
735086|NCT01462084|All patients were recruited from a single sleep center in the United States.|
735087|NCT01462045|Nurse volunteers were recruited from the University of New Mexico Hospital through advertisement,between September 1, 2011 and March 31, 2012.|Participants gave their informed written consent before participation. Inclusion criteria were age greater than 18 years and employment as a nurse at the University of New Mexico (UNM) Hospital. Exclusion criteria included an inability to participate in the exercise program, or current use of systemic glucocorticoid.
735088|NCT01461993||
735089|NCT01461980||A total of 2648 participants were enrolled in this study. Of these, 19 participants were randomized but did not receive study vaccination.
735090|NCT01461928|Participants were identified for potential recruitment using pre-screening enrolment logs.|Participants were treated with an induction regimen (6 months) and received SC rituximab at a dose of 375 mg/m2 with chemotherapy followed by 2 years of Maintenance I SC rituximab of 1400 mg alone. Responding participants at the end of Maintenance I were randomized to either Maintenance II rituximab treatment or observation only.
735091|NCT01461863|Subjects recruited from HIV clinics in Dar es Salaam|Eligibility required that the woman be free of acute illness, have a BMI ≥18.5 kg/m2 and intend to exclusively breastfeed her infant for at least 3 months.
735092|NCT01461824||
735093|NCT01461811|Participants were recruited from ten US study centers.|Of the 154 participants enrolled, ten participants were considered enrolled, but not dispensed, due to not meeting inclusion criteria or withdrawal of consent. This reporting group includes all enrolled and dispensed participants (144).
735094|NCT01461733||
735095|NCT01461707||
735096|NCT01461668|Subjects were identified from MRSA samples tested for Mup-R from the UC Irvine Medical Center microbiology lab and from samples from participants who completed a separate clinical trial. Of 294 patients found to have mupirocin resistant isolates, 53 were consented and randomized. Three dropped out prior to any intervention.|
735097|NCT01461655|Start date: 21-NOV-2011 (FSFV - first subject first visit) Completion date: 26-APR-2012 (LSLV - last subject last visit)|
735098|NCT01461551|Patient recruitment took place from October 9, 2011 to January 12, 2012 in Ruijin Hospital. A total of 149 patients scheduled to undergo elective OPCABG surgery were assessed for eligibility, with 105 patients enrolled and allocated randomly.|A total of 105 patients enrolled and allocated randomly. Five of these patients were excluded after enrollment (four due to changes in surgical schedules, and one due to severe hemodynamic instability during clamping of the coronary artery and requiring cardiopulmonary bypass).
735099|NCT01461538|Oct 2011 - Dec 2014|One additional patient enrolled, but withdrew prior to treatment group assignment.
735100|NCT01461499||
735101|NCT01461473||
735102|NCT01461369||
735103|NCT01461096|In less than 18 months, the full study cohort of 575 participants (472 males and 103 females) were enrolled and randomized in A5298. The first participant was randomized on March 8, 2012 and the last was randomized on August 23, 2013.|
735104|NCT01461057||
735105|NCT01461044||In total, 228 participants were included but 1 participant did not fulfill the inclusion criteria, therefore not included in the analysis. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
735106|NCT01461005||
735107|NCT01460940||
735108|NCT01460927||
735109|NCT01460901|Patients were consented and screened in the outpatient clinic. First consent was 10/2012 and last consent was signed 2/2014.|Patients could withdraw at their discretion or were withdrawn for rapid disease progression.
735110|NCT01460875||
735111|NCT01460732||
735112|NCT01460719|A total of 88 participants were screened and 80 were enrolled.|
735113|NCT01460628||
735114|NCT01460446||
735115|NCT01460407||
735116|NCT01460381||
735117|NCT01460368||
735118|NCT01460342||The study consisted of 3 periods: a screening/wash-out period (pre-randomization, 1 day up to 4 weeks), a placebo lead-in period (pre-randomization, 4 weeks, participant-blinded), and a double-blind treatment period (post-randomization, 12 weeks).
735119|NCT01460303||
735120|NCT01460290||
735123|NCT01459913||Subjects received telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a)/ ribavirin (RBV). Planned duration of telaprevir treatment was 12 weeks. Minimum planned duration of Peg-IFN-alfa-2a/RBV treatment was 12 weeks; however, was dependent on virologic response during initial 12 weeks of telaprevir plus Peg-IFN-alfa-2a/RBV.
735124|NCT01459796|The study was conducted at 60 study sites in the United States (US) from 12 November 2011 to 02 November 2012. A total of 485 participants were screened in the study.|Out of 485 participants, 220 were randomized and treated in the study. Participants were randomized in 4:3 ratio to receive either Rilonacept 80 mg or Placebo.
735125|NCT01459783|Adult caregivers (CG) lived with dementia care recipient (CR) or were the main support for >6 months. CRs had to live in the community (no nursing home). Admin data (ICD-9 codes) yielded eligible CRs from Olive View Med Center+local clinics. CRs got recruitment mailings to give to CG. CG were also recruited at CR's memory clinic+community outreach|A research assistant (RA) got informed consent either in-person at clinic or by phone for outreach/admin data sources. Contact info was sent to the survey group who completed enrollment and a baseline survey; then participants were randomized by the RA. Between the survey and randomization, 3 CGs were found ineligible and 4 duplicates were found.
735126|NCT01459718|In this open-label, single arm study 31 participants were enrolled (one participant was screened twice and was assigned 2 screening numbers; therefore the number enrolled = 32). Of these enrolled participants, 13 were randomized.|
735127|NCT01459705||
735128|NCT01459653||
735129|NCT01459614||44 patients were consented and screened. Of these, 5 were screen failures and 39 were eligible and assigned to receive treatment.
735130|NCT01459588||
735131|NCT01459068||
735132|NCT01459016||
735133|NCT01458990|Participants recruited from McGuire VAMC hepatology clinics|
735134|NCT01458951||Participants were randomized to tofacitinib 10 milligram (mg) or placebo twice a day (BID)(4:1 ratio) after Protocol Amendment 2, which removed tofacitinib 15 mg BID. Due to low participant numbers, tofacitinib 15 mg BID was excluded from efficacy analyses, but was included in participant flow, baseline characteristics and adverse events analyses.
735135|NCT01458639|The recruitment period was November 14, 2012 to June 11, 2014. Subjects were recruited from US medical centers that performed Xenon-133 ventilation scans to evaluate patients for pulmonary embolism (PE).|Subjects suspected of PE to have Xe-133 ventilation/Tc-99m macroaggregated albumin (MAA) perfusion (VQ) scan. Must have at least one within 72 hours before imaging: D-dimer, Doppler ultrasound for deep vein thrombosis (DVT) or computed tomography angiography (CTA) for PE. Not have therapeutic dose blood thinner for > than 72 hrs prior to imaging.
735136|NCT01458587|Recruitment period was from 28November2011 - 4April2012 at 3 medical clinics in the U.S.|
735137|NCT01458574||
735138|NCT01458561|Recruitment was limited to potential subjects who were being seen by a liver surgeon because they required a liver resection procedure. The first site was cleared to begin recruitment on October 20, 2010 and recruitment was closed on August 31, 2012 when all investigators were formally notified of the decision to terminate the study.|All potential subjects were required to meet preoperative and operative screening criteria in order to be enrolled into the investigation and assigned to a treatment group.
735139|NCT01458535||
735140|NCT01458522|173 participants consented. 74 participants were randomized.|37 participants randomized to LCM, however 2 participants did not receive drug. 37 participants were randomized to fPHT and everyone received drug.
735141|NCT01458418|Enrollment took place between 9/17/2012 and 1/7/2013 in a clinical setting.|There were no pre-assignment details. All inclusion/exclusion criteria were measured using existing, standard of care data. All subjects who signed informed consent were randomized (although it is not now know which arm they were randomized to as no unblinding was ever done due to low enrollment and lack of data).
735142|NCT01458392||
735143|NCT01458366||
735144|NCT01458288|"Duration of the Study:
~This study will consist of a 14-day screening period, a 2- to 11-day treatment period, and a 7-day follow-up period.
~Number of Patients:
~Approximately 12 treatment evaluable patients will be enrolled in this study.
~Study Location: Single site in US."|
735145|NCT01458275||
735146|NCT01458249||
735147|NCT01458210||
735148|NCT01458171|This multicenter study enrolled subjects at nine study centers in Japan who had participated in the preceding pivotal study ZLB06_002CR (CT.gov identifier: NCT01199705).|Only subjects participating in the preceding pivotal study ZLB06_002CR (NCT01199705) were eligible. The enrolment visit of this study was on the same day as the completion visit of the preceding pivotal study ZLB06_002CR.
735149|NCT01458132|The study was conducted from 06 September 2011 to 25 February 2013, at 19 sites in 4 countries, France, Romania, United States, and Germany.|Of the 35 Fosdevirine -exposed participants, 19 consented to enroll in the registry, including 4 of the 5 seizure participants and 15 from the non-seizure group.
735150|NCT01458119|Eighty-five eligible participants with Fabry disease who completed treatment with migalastat in one of three previous studies (AT1001-011 [NCT00925301], AT1001-012 [NCT01218659], or FAB-CL-205 [NCT00526071]) were enrolled in this open-label extension study to enable the collection of long-term safety and efficacy data.|
735151|NCT01458106||
735152|NCT01457950||This study consisted of a screening phase of up to 2.5 months, a six-month Double-Blind Treatment Phase and a six-month Open-Label Extension Phase. 371 participants (par.) were screened, 135 par. entered the Double-Blind Treatment Phase, and 123 par. continued into the Open-Label Extension Phase.
735153|NCT01457924|A participant (par.) completed the study if he/she completed all assessments up to and including the 24 Week Follow-up Phase (FUP) (Week 48) without prematurely discontinuing.|A total of 324 par. with Relapsing-Remitting Multiple Sclerosis (RRMS) were screened and 232 par. were randomized to 24 Week Treatment Phase (Weeks 0-12 were placebo controlled) of the study. A total of 231 par. received at least one dose of double-blind Investigational Product (IP) and were included in the Safety Population.
735154|NCT01457885|75 Patients were enrolled. Only 74 began treatment. 3 of these patients were pediatric and were left off the subsequent analysis.|
735264|NCT01450943|120 subjects enrolled from which 2 study subjects were not randomized into any groups and were terminated from the study; therefore, we only had overall of 118 study subjects.|
735265|NCT01450826||
735266|NCT01450813||
735155|NCT01457846|This study was conducted in 11 countries. Enrolment started in November 2011 and last patient visit was in August 2013. In total, 960 patients were enrolled out of which 71 were randomised. A total of 67 patients received treatment , 40 of these patients received AZD4547 and 27 received Paclitaxel.|Patients ≥ 25 years with locally advanced or metastatic gastric adenocarcinoma that had FGFR2 polysomy or FGFR2 gene amplification and whose disease had progressed during or after 1st line therapy. Patients whose disease had progressed within 6 months following adjuvant or neo-adjuvant therapy could be included at the discretion of the investigator
735156|NCT01457703||
735157|NCT01457573|Potential participants were approached by the PI and Study Team in an outpatient urology clinic setting between October 2011 and December 2014 for recruitment to the male lower urinary tract symptoms study.|
735158|NCT01457521||
735159|NCT01457430||
735160|NCT01457417|Eight sites in the United States participated in the study and 7 of them enrolled patients. The Date of First Enrollment was 16 Jan 2012, and the Date of Last Completed was 06 Dec 2013.|Part A enrolled patients with histologically or cytologically confirmed multiple myeloma or advanced solid tumors. A dose escalation procedure was followed. Part B enrolled patients with non-small cell lung cancer. Following screening (up to 28 days prior to first treatment) if entry criterion was met, patients were eligible for enrollment.
735161|NCT01457352||"The study was conducted in part 1, 2, and 3:
~Part 1: 392 subjects Part 2: 376 subjects (SPARC0921), one death occurred in Part 2 of the study. Part 3: 296 subjects (SPARC0921 or Placebo0921)
~Efficacy results are presented for Part 3 and safety results are presented for Part 2 and Part 3 of the study as per the objectives of the study."
735162|NCT01457339||
735163|NCT01457196||Of the 2798 participants screened for eligibility, 2074 were deemed eligible, 459 failed processing/sequencing, 226 had a sample collection failure, 19 were pediatric patients who were excluded from the final cohort, and 20 consents were withdrawn.
735164|NCT01457053|Patients with acute decompensated heart failure|
735165|NCT01457014|Participants were recruited from pain treatment centers and clinics by either Pain Center/Clinic staff or staff from a Sleep Testing facility.|74 participants were screened; 40 were excluded after completing the diagnostic PSG (did not meet the inclusion/exclusion criteria).
735166|NCT01456962||
735167|NCT01456949|The first subjects was enrolled on 26 June 2012 and the first study cryoablation occurred on 28 June 2012. The last subject was enrolled on 21 August 2014 and the final study cryoablation occurred on 14 October 2014. As this was a single arm study, all subjects enrolled were planned to have a cryoablation procedure.|
735168|NCT01456936|A total of 11,186 participants were screened for participation in the study, of which 3042 participants were considered to be screen failures, leaving 8144 participants eligible for study participation (efficacy population). 86 participants (1.1%) did not receive study drug. A total of 8058 participants received study drug (safety population).|Participants were classified into 2 cohorts: participants without diagnosis of psychiatric disorder and participants with a stable diagnosis of psychiatric disorder confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID) 4th edition conducted at screening.
735169|NCT01456897||
735170|NCT01456780||
735171|NCT01456494||
735172|NCT01456299||
735173|NCT01456221|Adolescents were recruited between July 2012 and December 2015, from three Family Medicine clinics of the Mexican Institute of Social Security (IMSS) in Mexico City.|
735174|NCT01456195|Participants took part in the study at 109 investigative sites in United States, Bulgaria, Argentina, Ukraine, Guatemala, Slovakia, Mexico and Hungary from 02 November 2011 to 30 July 2013.|Participants with a diagnosis of Type 2 Diabetes Mellitis were enrolled equally in 1 of 3 treatment groups, once a day placebo, 25 mg fasiglifam or 50 mg fasiglifam.
735175|NCT01456169|A total of 1754 patients were screened at 125 investigative sites in Bulgaria, Estonia, France, Germany, Hungary, Italy, Lithuania, the Netherlands, Poland, Serbia, Slovakia, Spain, Sweden, and the United Kingdom from 31 October 2011 to 24 January 2013.|507 participants entered the azilsartan medoxomil 40 mg Single-Blind Monotherapy Treatment Period and 395 participants were eligible to enter the Double-Blind Treatment Period and were randomly assigned to 1 of 3 active treatment arms.
735176|NCT01456143||
735177|NCT01456130|Participants took part in the study at 14 investigative sites in Japan from 10 November 2011 to 16 March 2013.|Patients with type 2 diabetes with inadequate blood glucose control despite treatment with a rapid-acting insulin secretagogue as well as diet and exercise therapies were enrolled in a single treatment group.
735178|NCT01456052|Up to 60 participants were to be enrolled and treated in the blinded Treatment period across 24 US and international sites. The recruitment period lasted approximately 10 months.|The study consisted of an approximately 15 days Screening period prior to the blinded Treatment period.
735179|NCT01456039|This was a Phase 1/2 open-label dose-escalation study. Phase 1 part composed of Cohort 1 (9mg/m^2) and Cohort 2 (14mg/m^2). Japanese participants were enrolled in order from Cohort 1. The dose used in the Phase 2 part was determined based on the frequency of dose limiting toxicities in Phase 1.|Those with relapsed, recurring or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) were enrolled in the Phase 1 part of this study. In Phase 2, the target disease was relapsed, recurring or refractory PTCL only. Results are reported up to the data cut-off of 28 July 2015.
735180|NCT01456000|There were 405 participants enrolled in the study. Thirty nine of these participants were enrolled in the run-in phase and are not reported in the pivotal data. Of the remaining 366 enrolled participants, 13 were excluded from the study prior to randomization, resulting in a total of 353 randomized participants.|
735181|NCT01455545|Dates of recruitment: Jan 2011 to Jan 2012. Location: medical clinic. Sampling method: Non-Probability Sample. Ages Eligible for Study: 16 yars to 80 years. Genders Eligible for Study: both.|
735182|NCT01455519||51 subjects were enrolled at baseline. 13 withdrew from the study after visit 1, and 3 no longer met criteria at visit 2.
735183|NCT01455428|223 participants were randomized, as stated on clinicaltrials.gov. However, 1 was randomized by mistake, was considered a screen failure, and was not given any medication. As such, the actual number of participants randomized and assigned to treatment was 222.|
735502|NCT01436162||
735503|NCT01436149||
757776|NCT00201825|Patients were enrolled and received treatment between December 2004 and November 2007|
735184|NCT01455415|501 participants were screened, of whom 197 were withdrawn before randomization. 304 were randomized, of whom 3 discontinued before being treated. Participants were randomized at 47 centers in 3 countries: US (43), Czech Republic (3), and Italy (1). 4 centers received study drug but did not randomize participants.|Participants completed daily pain and sleep diary from Visit 1 (Screening) to Visit 9. Participants with a mean pain score ≥ 4 (moderate to severe pain) and those having completed ≥ 4 daily pain dairies over past 7 days and having a mean score of ≥ 4 at Visit 2 (Baseline) were randomized.
735185|NCT01455220||
735186|NCT01455194|Participants took part in the study at 5 investigative sites in Argentina, Brazil, Germany, Israel and Russia from 10 November 2011 to 15 August 2014.|Participants with a historical diagnosis of persistent bronchial asthma for at least 6 months,treated with a stable inhaled corticosteroid (ICS)dose for at least 12 weeks were enrolled in a single-blind baseline period receiving 160 microgram(mcg)ciclesonide,then a double-blind treatment period in 1 of 3 treatment arms: ciclesonide 160,320,640 mcg.
735187|NCT01455181|24 Subjects were enrolled between 8/2011 to 5/2012 at 3 Clinical sites in Hungary.|Subjects previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study, or enrolled in REPLACE and dropped out during optimization, but currently met inclusion/exclusion criteria for REPLACE.
735188|NCT01455064|Participants were recruited from within the patient population of two US diabetes clinical centers.|
735189|NCT01455012|This study started to enroll subjects in September 2011 in order to end up with 9 German centers with enrolled subjects.|Participant Flow refers to the Randomized Set (RS). RS consists of all subjects randomized into this study.
735190|NCT01454947||
735191|NCT01454934||A total of 735 participants were screened. Of these, 195 screen failed due to failure to meet inclusion/exclusion criteria, adverse events, withdrawal of consent, or other reason and were not randomized into the study. A total of 540 participants were randomized into the study. Of these, 3 were discontinued prior to treatment.
735192|NCT01454830|Recruitment period 12/2011 through 1/2014 Location type: clinical sleep center|
735193|NCT01454791||
735194|NCT01454778||
735195|NCT01454739||Participants who completed studies 8HA02PED [NCT01458106], 997HA301 [NCT01181128]), 997HA307 (NCT02083965) and 997HA309 (NCT02502149) were expected to be eligible to enroll in this study.
735196|NCT01454726|recruitment period: Jan 1, 2011-November 30, 2011 recruitment location: Department of Neurology, Xuan Wu Hospital of Capital Medical University|A total of 27 patients were enrolled and randomly attributed to either experimental or control group.
735197|NCT01454596||All patients were treated on the Ph I portion of the study. After encountering a patient mortality at dose level 8 and a grade 3 pulmonary toxicity at dose level 9 without seeing any clinical responses, the principal investigator and senior staff re-evaluated the protocol and elected to close the protocol rather than proceed into the Ph II portion.
735198|NCT01454583||
735199|NCT01454570|All participants were recruited, consented, screened and eligible subjects were enrolled at the James J Peters VAMC|
735200|NCT01454531||"199 subjects were recruited and 3 resulted screening failures so 196 subjects started the trial. Four subjects discontinued before treatment so 192 subjects were treated. The reason for discontinuation for these 4 subjects was withdrawal of consent (Withdrawal by subject, included in Reasons Not Completed)"
735201|NCT01454505|Subjects were recruited from one study center in Canada.|50 healthy volunteers were enrolled in Stage A and subsequently exited from the study. 60 unique patients were enrolled in Stage B.
735202|NCT01454414||
735203|NCT01454401|"Recruitment period: 18-01-2011 (FPI) to 14-01-2013 (LPO)
~Non -ischemic Wagner grade 1 or 2 diabetic foot ulcer (DFU) with a duration of more than 6 weeks and a maximal area of 10 cm2
~Patients with > 40% ulcer area change during a two-week run-in period were excluded."|16 patients were excluded during run-in period: >40% ulcer area reduction n=5 HbA1c > 12% n=3 haemoglobin < 9,5% g/dl, n=1 ulcer area > 10 cm2, n=1 amputation n=1 withdrawn consent, n=2 Osteomyelitis n=1 wrongly included n=2
735204|NCT01454362|Participants were recruited at the Tobacco Dependence Research Unit in London between January 2013 and February 2013.|"Inclusion Criteria Smoking at least 12 cigarettes per day; first cigarette smoked within 60 mins of waking; willing to abstain from smoking for one day in 2 consecutive weeks.
~Exclusion Criteria Under 18s; current psychiatric illness; planning pregnancy, pregnant or breastfeeding; enrolled in other research; used EC or inhaler before."
735205|NCT01454284||
735206|NCT01454258||
735207|NCT01454102||472 participants were enrolled; 376 participants received at least one dose of study treatment
735208|NCT01454076|Participants took part in the study at 4 investigative sites in the United States from 10 November 2011 to 16 June 2016. An additional 1 center was activated but did not screen or enroll any participants.|Participants with advanced nonhematologic malignancies or lymphoma were enrolled in this 5 arm study to receive one of the following treatments in Cycle 1: ixazomib + ketoconazole; ixazomib Capsule A or B formulation; ixazomib in fasted or fed state; ixazomib + rifampin; ixazomib + clarithromycin; Cycle 2 up to Cycle 12: ixazomib alone in all arms.
735209|NCT01454063||
735210|NCT01453998|A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 after the amendment. After amendment 2, all subjects yet to receive a booster dose of a GSK217744 formulation, were administered the Infanrix hexa vaccine.|
735211|NCT01453946|In this study, 55 patients were enrolled but only 50 fulfilled the enrolment criteria.|55 patients were enrolled but only 50 received treatment.
735212|NCT01453894|Eligible patients identified by query of electronic health record.|
735213|NCT01453855|Subjects were recruited from 60 investigational centers, including 52 in the US, 2 each in Sweden, Germany, and Austria, and 1 each in Spain and Finland.|Of the 1099 enrolled, 235 did not meet inclusion/exclusion criteria and were exited from the study prior to randomization. This reporting group includes all randomized subjects (864).
735214|NCT01453725||These data are for Parts 1 and 2 of the study.
735215|NCT01453595||
735216|NCT01453569||
735217|NCT01453439||
735218|NCT01453413||
735219|NCT01453387|First/Last subject (informed consent): 09 September 2011/18 April 2013. Study completion date: 15 July 2013, Clinical data cut-off date: 15 July 2013; Subjects were randomized at 3 centers in United States.|Enrolled: 28 subjects were screened for eligibility and all were randomized in to the trial.
735220|NCT01453374|Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (3 for men and 1 for women) received 1 injection of VIVITROL prior to release from prison and were offered 6 monthly injections of VIVITROL after release from prison, for a total of 7 injections.|Eligible subjects had a diagnosis of opioid dependence, were seeking treatment, and were eligible for release from prison within 30 days from screening.
735221|NCT01453361|This study recruited patients with Stages IIIc and IV melanoma.|18 were enrolled but 10 screen-failed so only 8 proceeded with the single group assignment (Vigil treatment).
735222|NCT01453348|Subjects were enrolled at four centers in Germany.|All enrolled subjects were included in the trial.
735223|NCT01453296|Participants were enrolled into one of two cohorts based upon age; the younger cohort was enrolled after a review of the safety/pharmacokinetic data of at least six participants from the older cohort. Each participant was assigned to treatment randomly; assignment was not to be influenced by whether participants were in Cohort 1 or Cohort 2.|A Baseline assessment was carried out on Day 1 of the first treatment period. Participants were then randomized to one of the two possible treatment sequences (Vilanterol [VI] 25 micrograms [µg] followed by matching Placebo; matching placebo followed by VI 25 µg) in a 1:1 ratio in an AB or BA sequence.
735224|NCT01453205|The study was conducted from 27Feb2012 to 17Jun2016.|A total of 256 participants were screened, of which 187 participants were randomized in the study.
735225|NCT01453166|151 patients agreed to participate of the screening day in the Hospital do Coração in São Paulo Brazil. After eligibility set, From September 2011 to December 2011,122 patients were randomized for one of three treatment groups|Of those ineligible, 9 missed the screening day, 14 did not present previews cardiovascular event, 3 declined to participate. After randomization, two patients were identified as ineligible to present chronic renal and hepatic insufficiency, and three dropped out of the study Among those who met inclusion criteria, 117 participants completed study
735226|NCT01453153||This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGylated Recombinant Human Hyaluronidase PH20 (PEGPH20).
735227|NCT01453075||
735228|NCT01453049||
735229|NCT01453036|five hospitals affiliated with the Catholic University who visited from August 2011 to June 2012|Mutation test group ; Patients which are no detection of H. pyloriare were excluded
735230|NCT01453023|Participants were enrolled into one of two cohorts based upon age; the younger cohort was enrolled after a review of the safety/pharmacokinetic data of at least six participants from the older cohort. Each participant was assigned to treatment randomly; assignment was not to be influenced by whether participants were in Cohort 1 or Cohort 2.|A Baseline assessment was carried out on Day 1 of the first treatment period. Participants were then randomized to one of the two possible treatments fluticasone furoate [FF] 100 µg/Vilanterol [VI] 25 µg.or FF 100 µg, followed by a cross over after a washout period of at least 7 days.
735231|NCT01452854|Low recruitment necessitated the closing of the study. No results available.|
735232|NCT01452789|From November 1, 2011, to May 29, 2016, we enrolled term infants (≥37 weeks of gestation) who had been exposed to opioids in utero and had signs and symptoms of the neonatal abstinence syndrome.|
735233|NCT01452529|First subject first visit: 23-March-2012; Last subject last visit: 03-September-2013. The study was conducted at medical/research sites in the United States.|Subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen were included.
735234|NCT01452425||
735235|NCT01452412||
735236|NCT01452347||76 patients were not entered/randomized
735237|NCT01452269||
735238|NCT01452191||
735239|NCT01452152||
735240|NCT01452126||
735241|NCT01451996||
735242|NCT01451983||
735243|NCT01451931||
735244|NCT01451827|The trial was conducted in 177 participants at 41 trial states in the United States.|Participants entered a screening period within 4 weeks of being randomized (1:1:1:1) to one of four treatment groups. 178 is the number of subjects who enrolled due to informed consent, 177 is the number of subjects who were assigned to each treatment group.
735245|NCT01451814||
735246|NCT01451775||This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments.
735247|NCT01451762|90 subjects were enrolled between September 2011 and September 2012.|
735248|NCT01451749|9 sites in China were conducted patients from September 1, 2008, to May 3, 2010.The 9 sites was medical clinic in hospital.|
735249|NCT01451723||
735250|NCT01451645|Overall, 82 patients from 20 clinical sites participated in the study between 19-October-2011 to 27-August-2012.|Participants were assessed at an initial screening visit within 3 to 14 days before the baseline visit. At the baseline visit, eligible participants were then assessed, randomized, trained on daily dosing & the daily dosing/flare diary, and initiated on allopurinol and study drug (colchicine or placebo).
735251|NCT01451632||
735252|NCT01451606|Recruitment period: July 2011 - Dec. 2015. Recruitment from medical clinic and through public advertisements.|In person visit to complete eligibility screening.
735253|NCT01451554|Patients were referred to the study by their primary health care provider. Recruitment began on January 14, 2009 and ended on May 21, 2010.|
735254|NCT01451541||
735255|NCT01451463||
735256|NCT01451437||No participant in Part 1 received combination therapy (MK-8242 + cytarabine). Study Part 2 was not performed due to early termination of the study.
735257|NCT01451424||
735258|NCT01451411||
735259|NCT01451398|First Patient enrolled November 2011. Multi-national trial conducted in US, Russia, Ukraine and Brazil|6 week Screening Period prior to OAD run-in period. 1379 Screened /539 Eligible of which 535 entered the run-in period. 439 met randomization criteria at end of run-in of which 353 were randomized.
735260|NCT01451385||After a screening period of up to 14 days, enrolled participants began treatment
735261|NCT01451372||
735262|NCT01451203|Participants with early rheumatoid arthritis (RA), methotrexate (MTX)-naïve and had poor prognostic factors were recruited for this study.|
735263|NCT01451164||
735267|NCT01450800|Patients who received postoperative transurethral catheterization after surgery for pelvic organ prolapse, urinary incontinence, or both by the Division of Urogynecology at Duke University Medical Center from 8/2011 through 2/2013 were identified, recruited and enrolled after providing written informed consent at a routine pre-operative visit.|Randomization occurred within a few hours after surgery. Participants were excluded prior to randomization if they sustained intraoperative injury to the urinary tract requiring prolonged catheterization, or if they passed an immediate void trial on day of surgery (as these participants did not receive additional postoperative catheterization).
735268|NCT01450787|Subjects were enrolled randomly. Consecutive patients in a private ophthalmology clinic that met inclusion criteria were asked to participate at the time of an already scheduled exam. The non-diabetic group recruitment stopped once the target number of subjects enrolled. The diabetic group recruitment continued until the study was terminated.|Being that there was no intervention and the study only involved taking measurements at the time of the exam, there was no transition required. Any eligible patient that was willing to participate was included. Consecutive diabetic patients and consecutive non-diabetic patients that met criteria were offered the opportunity to enroll.
735269|NCT01450761||Of the 1414 enrolled participants, 566 participants each were randomized to Ipilimumab and placebo arms. The remaining 282 participants were not randomized, the most frequently reported reason being that the participants no longer met study criteria.
735270|NCT01450696||A total of 248 participants (124 participants per arm) were randomized in the study up to data cutoff date of 13 February 2015, and 48 additional participants (24 participants per arm) were randomized between data cutoff date of 13 February 2015 and end of study (25 August 2015) for additional safety data.
735271|NCT01450683||
735272|NCT01450631|Subjects for the study were recruited from a hospital Labor and Delivery Unit. Recruitment period: 26JAN2012 (site initiation) - 17DEC2013 (LPO)|
735273|NCT01450397|Subjects were enrolled from July 2011 to December 2011. Enrollment was completed in a medical clinic.|
735274|NCT01450319||A total of 73 subjects were enrolled in the trial. Out of 73 subjects, 70 subjects received the study drug and start the study and three subjects were excluded from the modified intent-to-treat (MITT) analysis set.
735275|NCT01450306||
735276|NCT01450189|Participants were recruited through screening in two sexually transmitted disease clinics and two HIV testing sites in Lilongwe, Malawi.|Participants were evaluated in two stages: screening for acute HIV infection (AHI) and enrollment of persons with AHI for follow-up. As this is a pilot study, some outcomes refer to screening only. The original protocol called for 115 persons with AHI; only 46 persons were enrolled as the study period ended and funding expired.
735277|NCT01450137||
735278|NCT01450098||
735279|NCT01450007|Participants were recruited at Mayo Clinic in Arizona from June 2012 to September 2014.|238 patients were screened; of these 41 were excluded because they did not meet inclusion criteria, and 67 were excluded because they declined to be in the study.
735280|NCT01449955|Recruited by flyers, clinician referral and letters mailed to male VA North Texas patients with PTSD.|excluded if did not meet PTSD criteria according to the CAPS
735281|NCT01449929|This was a 2 sequential treatment period study. In first period (Randomization phase) participants received either dolutegravir (DTG) 50 milligram (mg) or darunavir (DRV) 800 mg with ritonavir (RTV) 100 mg once daily (QD) for 96 weeks. DTG participants who completed 96 Weeks of DTG then continued to receive DTG 50 mg in Extension phase.|A total of 595 participants were screened; 107 were screen failures; 488 were randomized; 485 received at least 1 dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population of which 1 participant was removed, creating the modified ITT-E population with 484 participants. 123 participants enrolled in Extension Phase.
735282|NCT01449864||
735283|NCT01449812|6 subjects did not receive vaccination.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
735284|NCT01449747||
735285|NCT01449734|Prospective cohort study performed in four (mixed surgical, neurological, and cardiological) intensive care units of a university hospital in Germany|
735286|NCT01449721||Prior to interventional arm of the trial, a 5-month observational period was performed identifying 94 patients in the control arm. At the initiation of the interventional study, subjects were randomized in a 2:1 ratio to intervention:control, enrolling an additional 18 patients to the control arm, and 30 patients to the intervention.
735287|NCT01449708||
735288|NCT01449682||
735289|NCT01449630||Three period crossover study with three dosing cohorts. The interval between the initiation of each dosing cohort was approximately 1 week, and the washout time between each dosing period was approximately 3 weeks.
735290|NCT01449539||
735291|NCT01449526|This was a three month study enrolling 166 participants from 12 investigative sites in the United States. First participant was enroled on 08/08/2011, and last participant exited the study on 12/08/2011.|166 participants were enrolled in the study with 158 participants completing the study. A minimum of 68 participants were to be of Japanese descent (both maternal and paternal grandparents born in Japan) for submission to the Japanese Regulatory Agency.
735292|NCT01449513|Start date: 27-Sep-2011 (FSFV - first subject first visit) Completion date: 22-May-2012 (LSLV - last subject last visit)|
735293|NCT01449461|Participants took part in the study at 9 investigative sites in the United States and Spain up to clinical cut-off date 16 November 2015. Study is ongoing.|Participants with advanced malignancies, all histologies other than leukemia were enrolled in dose-escalation and participants with non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangements were enrolled in dose expansion phase. Participants received brigatinib 30 mg - 300 mg, tablets, orally once daily or twice daily.
735294|NCT01449370|Participants took part in the study at 5 investigative sites in England, Spain and the United States from 06 October 2011 to 15 January 2016.|Participants with advanced solid tumors were enrolled in dose escalation phase to receive TAK-117(MLN1117) in 1 of 4 treatment regimen.Study originally used clinical trial material(CTM) in Process A and new CTM in Process B. Due to limited single-agent TAK-117 activity in dose escalation phase,Study was terminated before start of planned expansion.
735542|NCT01433978||One screen-failed participant was randomized into the study in error, but not dosed.
735543|NCT01433913||
735295|NCT01449305|Forty-four (44) subjects enrolled into the study. Forty-two (42) subjects completed the study from 2011-10-11 to 2012-06-23 at the PingTung Christian Hospital (60, Dallan Road, Pingtung, Taiwan).|This is an Open-label study design. The subject must be qualified for the study by fulfilling all of the inclusion and none of the exclusion criteria. Laboratory values which are out of reference range will not qualify unless the physician deems the deviation not clinically significant (NCS).
735296|NCT01449279|Subjects were recruited during clinic visits at the Stanford Cancer Center clinic. Subjects were informed of all options and given time to ask questions before signing consent in a private room.|
735297|NCT01449266||
735298|NCT01449240||
735299|NCT01449006|Participants were recruited from St Vincent's Hospital and/or referred from tertiary sexual health centres over the period January 2012 to June 2013.|Two enrolled participants failed screening (1 HCV+, 1 not cognitively impaired)
735300|NCT01448850||A total of 464 participants were screened and 324 participants were randomized into the study.
735301|NCT01448824||This was a 2-part study, multiple ascending dose (MAD) and drug drug interaction (DDI). Participants were randomized to (Part 1) to 4 cohorts (Cohorts A through D) and randomized to receive either LY2484595 (5 ascending dose levels) or placebo. Cohort A consisted of 2 periods separated by a washout period of 14 days. DDI had 2 periods.
735302|NCT01448707||325 participants screened, among them 282 were eligible for run-in phase and among them 274 enrolled to the study. 1 randomized participant was not treated (274 participants were randomized).
735303|NCT01448616||
735304|NCT01448525||
735305|NCT01448486|Recruitment period from October 2011 to October 2013. Participants were known patients of the PI or referred from local tertiary sexual health clinics by associate investigators.|
735306|NCT01448421||
735307|NCT01448356||
735308|NCT01448213||
735309|NCT01448057||
735310|NCT01448044||A total of 152 participants were enrolled in the study, of which 125 were randomized and 27 participants were not randomized due to 23 no longer met criteria, 1 withdrew consent, 1 due to administrative reason, and 2 other reasons. Of 125 randomized, 124 were treated and 1 was not treated due to withdrawal of consent.
735311|NCT01447927|Ninety-three subjects were pre-registered through 12 Cancer Prevention Network (CPN) member organizations from February 2012 and January 2013.|One subject withdrew post-randomization and did not receive any treatment and 18 subjects were excluded from the trial before assignment to groups: 8 out of range lab values, 4 high grade dysplasia/esophagitis/esophageal stricture, 2 intestinal metaplasia on <25% of biopsies, and 4 other reasons.
735312|NCT01447914|Total Recruitment Period: November 30, 2011 to August 1, 2013. All recruitment done at University of Texas (UT) MD Anderson Cancer Center.|
735313|NCT01447888||
735314|NCT01447849|During an entire recruitment time all patients signed their consent forms and participate in the study protocol within the specially designated clinical research room at Texas Tech University Health Sciences Center(TTUHSC), El Paso.|"Patients interested in our study were interviewed and examined 1 week before the 1st assigned after randomization medication was administered for one week of therapy.
~Subsequently, when patients finished their first week of medication, they had one week as of wash-out before the 2nd therapy in this cross-over design of our study protocol."
735315|NCT01447719||Demographic results are only provided for primary analysis populations of subjects who came to autopsy. Demographic characteristics for the entire population of 152 subjects are reported with the results of study A07 (NCT00857415).
735316|NCT01447706||
735317|NCT01447576|1036 participants entered trial, including 792 who had rolled over from previous studies and 244 de novo participants. Of the 792 rollovers, 337 were 6-week enrollers and the 52-week enrollers consisted of 699 enrolled participants (455 rollover and 244 de novo). This was a single arm study and all participants received the same treatment.|Eligible participants received daily treatment with open-label brexpiprazole (0.25 up to 3.0 milligrams (mg)/day) and commercially marketed ADT.
735318|NCT01447511||Thirty-nine participants were enrolled in the study; however, only twenty-nine of the enrolled participants participated in the study. Per study protocol, participants with the CYP2C9*1B/*1B haplotype did not complete the Fluconazole Period. Individuals with the CYP2C9*1B/*1B haplotype only completed the Control Period and Rifampin Period.
735319|NCT01447446|A total of 4442 participants were enrolled in the study, one participant had double enrollment. Out of 4442 participants, analyses were restricted to only core population, which included 4100 participants.|
735320|NCT01447433|Participant were recruited through informational flyers and advertisements posted on campus of colleges and vocational schools in Pudong and Yangpu Districts in Shanghai, China. From April 20th to September 20th, 2011, a total of 129 out of 187 volunteers who answered our recruitment advertisements were invited for a pre-screening interview.|The pre-screening FFQ excluded 34 volunteers for habitual calcium intake>600mg/day. During screening, 16 were excluded for BMI<24kg/m2, 3 reported for using calcium supplements, 14 were on a diet, 2 refused to take calcium supplements, 1 refused to being taken blood samples, and 6 failed to sign the informed consents for personal reasons.
735321|NCT01447420|A total of 129 participants were enrolled from February 2011 to November 2012 at 14 study sites in Brazil.|
735322|NCT01447407||Four subjects withdrew before completing Day 28 and were replaced. One subject withdrew before the last visit. While this subject is not considered to have completed the study, data from this subject are included in the immunogenicity and culture results.
735323|NCT01447225||
735324|NCT01447121||
735325|NCT01447017|Male and female patients, aged 12 years and above, with a clinical diagnosis of acute external otitis of a severity that is normally treated by primary care were included in the study. The first patient entered the study on January 2012 and the last patient completed the study on November 2012|
735326|NCT01446913||Three patients withdrew prior to randomization.
735327|NCT01446874|The study opened to participant enrollment on 09/22/2011 and closed to participant enrollment on 06/08/2016.|
735328|NCT01446809||
735329|NCT01446796||One subject provided initial consent but withdrew his consent prior to undergoing left ventricular assist device implantation. No further research activities for the study were performed with respect to this subject.
735330|NCT01446705||
735544|NCT01433731||
735331|NCT01446666|Study participants were recruited between November 2011 and August 2012. The inclusion criteria for participation were an age of 20 years or older and the presence of cirrhosis with an estimated annual HCC risk of >5%.|The absence of hepatocellular carcinoma (HCC) had been evaluated by US, dynamic CT scan, or MRI within 6 months before enrollment. Patients with Child-Pugh class C liver function or estimated glomerular filtration rate <30 mL/min/1.73m^2 were excluded.
735332|NCT01446419|Subjects were screened and enrolled at 15 sites in the US and 3 sites in Germany|2:1 Randomization (treatment: sham)
735333|NCT01446289|Participants were recruited from 5 centres.|A total of 86 pregnant subjects were enrolled in the study. 86 infants were enrolled in this study, delivered by 86 maternal subjects. There were 86 singleton deliveries.
735334|NCT01446250||
735335|NCT01446237|A total of 125 participants of 12 to 35 years from 9 centers in the United States were enrolled in this 12 Week study to evaluate the efficacy and safety of the MaxClarity System in participants with acne. The study started on 23 June 2011 and completed on 14 December 2011.|
735336|NCT01446159|The study was conducted across 10 countries (Belgium, Canada, France, Germany, Hungary, Israel, Spain, Poland, United Kingdom, USA).|A total of 187 participants were screened in the study. Of which, 183 participants were treated with study drugs.
735337|NCT01446042||
735338|NCT01446003||
735339|NCT01445951|First Patient enrolled Sept 2011. Multi-national trial conducted in US, Russia, Ukraine and Brazil.|3 week Screening Period prior to run-in (basal insulin optimization period). 1401 Screened / 621 Eligible of which 614 entered the run-in period. 538 met randomization criteria at end of run-in of which 518 were randomized.
735340|NCT01445886|Subjects with nail psoriasis were recruited from the outpatient Department of Traditional Chinese Medicine and Dermatology at the Chang Gung Memorial Hospital (CGMH), Taiwan from January 2011 to May 2012.|This study screened 43 subjects with 33 recruited, and 28 subjects finished the study. ( 2 failure to return, 7 violation of selection criteria at entry, 3 other protocol violation and 3 refused treatment/withdraw violation)
735341|NCT01445873|Data for this retrospective non-interventional study were abtracted from the medical records of subjects who met study entry criteria.|Patterns of treatment with Thelin including duration and daily dosages reflect treament participants received in clinical practice. Treatment was not specified by the protocol.
735342|NCT01445847|Study conducted at King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia at Jan 20, 2012. Recruitment was done at Their wards within 24 hours prior to the operation|Patients were able to refuse to participate before anesthesia induction start. Therefore, patients may excluded from the study due to that reason and we decided to start assignment to groups randomly when anesthesia is induced to the patient.
735343|NCT01445821||
735344|NCT01445769||
735345|NCT01445678||Two identical P3 protocols were initiated (NCT01445678 and NCT01445665) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. A total of 993 subjects were randomized to both arms, 493 to NCT5678 and 500 to NCT5665. Of these, 485 and 494 received treatment.
735346|NCT01445652|Participants were enrolled from one study center in the United Kingdom.|Of the 113 participants enrolled, 3 were exited as screen failures prior to randomization. This reporting group includes all enrolled and randomized participants (110).
735347|NCT01445626||
735348|NCT01445613|Enrollment for the CANOPY clinical trial started on October 11, 2011 and was completed on September 12, 2013. The enrollment goal (1200 subjects) was reached with a total of 1203 subjects enrolled at 97 clinical sites.|3/1203 subjects who received a non-study stent, were excluded from the analysis. A total of 1200 subjects were included in the primary analysis population (Full analysis set (FAS)).
735349|NCT01445548||
735350|NCT01445535||
735351|NCT01445301|A total of 800 Japanese participants across 26 investigational centers in Japan, with Acne Vulgaris were enrolled in this study. The study was conducted from 27 September 2011 - 02 August 2012.|
735352|NCT01445171||
735353|NCT01445028||
735354|NCT01444924||A total of 75 patients agreed to participate in the study. Eight patients did not meet inclusion criteria for the study, 2 patients were excluded from the analysis secondary to intraoperative conversion to laparotomy, and 1 additional patient was excluded because the robot was unavailable. This left a total of 64 subjects who completed the study.
735355|NCT01444911|Participants with a history of a gynecologic cancer and self-reported sexual dysfunction that was new or worsened since cancer diagnosis, and were randomized to one of two arms. All participants enrolled at the Gynecologic Oncology and Radiation Oncology clinics at the University of Wisconsin Carbone Cancer Center.|
735356|NCT01444898||
735357|NCT01444781|The study participants were enrolled from 26 September 2011 through 19 July 2012 at 2 clinic centers in Colombia and Costa Rica.|A total of 1106 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
735358|NCT01444742|Recruitment Period: 11/2011 to 10/2015|Of the 81 participants registered, one participant was never treated with the study medication. All Participants were registered at The University of Texas MD Anderson Cancer Center.
735359|NCT01444651||111 participants screened, 38 excluded (34 did not meet eligibility criteria, 2 unable to obtain intravenous access, 2 withdrew consent)
735360|NCT01444456|Open to patients receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia. First patient enrolled 10 october 2011; last patient enrolled 28 May 2013.|Before enrolling participants, each country was assigned to either cohort 1 (patients receiving only darbepoetin alfa) or cohort 2 (patients receiving any ESA). Cohort 2 was assigned only to those countries in which local regulations did not permit observational study participation by participants receiving a specific agent in a drug class.
735361|NCT01444430|This study started with an assessment visit where inclusion/exclusion criteria were reviewed and informed consent obtained. Eligible patients were randomized at the next visit. Patients then entered a 26 weeks double-blind treatment period followed by a 1 week follow-up telephone contact. Patients were recruited in 25 countries with 25% in the US.|Eligible adult and adolescent patients were stratified based upon assessment of ACQ and prior asthma therapy and randomized 1:1 to double-blind Symbicort or budesonide. 12460 patients were enrolled (informed consent received) and 11693 were randomized.
735362|NCT01444417|This study was conducted at 27 centers in the United States, Canada, and Australia. Participants were enrolled from 24 January 2012 to 03 September 2014.|Participants who met eligibility criteria were enrolled and stratified by the following 3 age categories: ≥ 1 to < 6 years; 6 to < 12 years; and 12 to < 18 years.
735363|NCT01444391||
735364|NCT01444378|The first patient was registered in the MOMENTUM trial on November 2011. Enrollment in the trial was closed on November 2013. Based on the February 19, 2015, data extraction, 141 patients were registered in the MOMENTUM trial.at 32 US sites|
735365|NCT01444300|People with MS were recruited from several MS clinics in the Portland, OR metro area from September 2011 to August 2013. 24 subjects signed the consent and were enrolled in the study.|
735366|NCT01444287|There were 22 subjects enrolled to the study, all completed the four experimental sessions.|
735367|NCT01444092|"123 patients were screened/enrolled, but only 108 received treatment. The other 15 did not meet the inclusion/exclusion criteria. They only appear in the disposition tables in the CSR (Tables 8 and 10) and did not start in the study."|"123 patients were screened/enrolled, but only 108 received treatment. The other 15 did not meet the inclusion/exclusion criteria. They only appear in the disposition tables in the CSR (Tables 8 and 10) and did not start in the study."
735368|NCT01444027||
735369|NCT01443923||
735370|NCT01443858|Recruitment began on 9/16/11 and ended on 11/30/12. Of the 146 subjects consented during this period, 72 were in our Charlotte, NC office, 45 were in our Durham, NC office and 29 were in our Raleigh, NC office. Of the 146 subjects consented during this study only 75 subjects met all study criteria and were assigned to a study arm.|
735371|NCT01443845|Recruitment occurred from September 2011 to October 2014 for a total of 380 study centers screened patients for the study: Italy, Spain, United States, Ukraine, Argentina, Russia, Philippines, Romania, Serbia, Canada, Malaysia, Thailand, Mexico, Peru and Taiwan.|The study consisted of 2 weeks of single-blind placebo lead-in with fixed-dose combination (FDC) long-acting β2-agonist(s) (LABA)/inhaled corticosteroid(s) (ICS) treatment followed by 52 weeks of double-blind treatment in addition to maintenance FDC LABA/ICS.
735372|NCT01443546||
735373|NCT01443494||
735374|NCT01443442||
735375|NCT01443403|"This study was conducted at 53 clinical sites in the United States. The first participant was enrolled on August 17, 2011 and the last participant completed on August 22, 2012.
~Participants must have met eligibility criteria and completed the Bowel Movement and Constipation Assessment (BMCA) Diary for a minimum of 14 days to enroll in the study."|"Participants were randomized in a 1:1:1:1 ratio to receive placebo, naldemedine 0.1 mg, 0.2 mg, or 0.4 mg once daily.
~One participant was randomized twice, first to placebo and subsequently to naldemedine 0.4 mg, and is counted in both arms below and for safety analyses."
735376|NCT01443364|This study started to enroll patients in December 2011 and concluded in May 2015.|Participant Flow refers to all subjects randomized who have received at least one dose of study medication.
735377|NCT01443130|Participants were pregnant women in their first or second pregnancy recruited during presentation at the Ndirande Antenatal Clinic (ANC) at the Ndirande Health Centre, enrolled between 22 February 2012 and 16 May 2014.|The infants born to these participants were also enrolled in the study to be assessed at birth and followed to 14 weeks. The infants are reported here as separate arms of the study, grouped by the study product given to the mother.
735378|NCT01443078||
735379|NCT01443026||
735380|NCT01442844||
735381|NCT01442779|Medical clinic|
735382|NCT01442714||
735383|NCT01442688||
735384|NCT01442675|The study participants were enrolled from 26 September 2011 through 21 December 2011 at 15 clinic centers in the United States.|A total of 834 participants who met all of the inclusion and none of the exclusion criteria were randomized; 831 were vaccinated in this study.
735385|NCT01442493||
735386|NCT01442376||A total of 502 patients were enrolled and randomly assigned to treatment. Study drug was not administered to 8 randomized patients, of these patients 2 had also an adverse event and were counted under this category in overall study statement. Therefore 494 patients did receive the study drug and are part of the analysis for the safety population.
735387|NCT01442181||
735388|NCT01442155||Two participants were screening failures. 74 participants were assigned to the study and treated with study drug.
735389|NCT01442129|The trial was conducted in 11 U.S. centers with a Data and Clinical Coordinating Center (DCC); International Center for Health Outcomes and Innovation Research [InCHOIR], Icahn School of Medicine at Mount Sinai under an investigational new drug application. Enrollment began in May 2012, and the last patient was enrolled in August 2012.|
735390|NCT01442103|The recruitment period was from 15 September 2011 - 01 May 2012. The study was conducted at the Advanced Burn and Wound Clinic at the Joseph M. Still Burn Center in Augusta, Georgia.|"PreAssignment details:
~There was not wash-out or run-in phase included in the study. Subjects were expected to have at least 2 signs of local irritation or inflammation but no active or systemic infection at the time of consent."
735391|NCT01442064|This is an open label multi-center extension study for participants who completed FVF4165g BRAVO (NCT00486018) or FVF4166g CRUISE (NCT0048583). Cohort 2 consists of enrolled participants with macular edema secondary to retinal vein occlusion (RVO).|
735392|NCT01442038|Participants were enrolled at study sites in the United States, Canada, Europe, Russia, and Israel. The first participant was screened on 03 November 2011. The last study visit occurred on 09 February 2015.|2734 participants were screened.
735393|NCT01441973||The study enrolled a total of 41 participants, and 31 received treatment. The 10 participants enrolled who did not receive treatment failed to meet the inclusion criteria.
735394|NCT01441960|45 hospitalized patients aged 24-80 admitted for a series of ECT treatments at a frequency of 3/week were enrolled. 14 were excluded (1 received rocuronium in error, 1 received succinylcholine in error, 1 withdrew consent, 2 did not complete series of ECT, and in 9 twitch monitoring problems resulted in non-captured or disqualified data.|Patients were randomized to either succinylcholine or rocuronium during their first ECT. During each subsequent ECT ( 2 days apart) patients received a 10% higher (if insufficient paralysis) or lower dose (if sufficient or excessive paralysis) until the minimum effective dose was identified. Then the second NMBA was tested for subsequent ECTs.
735395|NCT01441882||
735396|NCT01441843||
735397|NCT01441765||
735398|NCT01441635|Overall, 271 female participants were enrolled into the study across 45 sites in the United States.|Six cohorts of participants were enrolled, with 3 double-blind cohorts comparing elagolix with placebo, 2 open-label cohorts assessing add-back therapies, and 1 open-label cohort assessing the elagolix 600 mg QD dosing regimen.
735399|NCT01441596||
735400|NCT01441570||
735401|NCT01441492||
735402|NCT01441466|Of 84 eligible patients, 48 were included in the study|
735403|NCT01441440||Subjects were confirmed to meet entry criteria at the screening visit, followed by a 2-week screening period. Subjects who continued to meet all study entry criteria at baseline were randomized to 10 weeks of treatment with placebo, venlafaxine ER 75 mg/day Fixed, or venlafaxine ER 75-225 mg/day Flexible in the ratio of 1:1:1.
735404|NCT01441414|This multicenter, open-label study consisted of a safety lead in stage (Part I) followed by a randomized Phase 2 stage (Part II). A total of 18 participants were screened and assigned to treatment in Part I, with 3 participants completing Part I of the study. At the completion of Part I, all 18 participants had discontinued combined treatment.|During Part I, 3 to 4 participants were initially treated with the study drug combination in 28-day cycles. If no participants experienced Cycle 1 dose limiting toxicities (DLTs), another 6 to 9 participants were treated at this dose level. Part II of the study was to be initiated if Cycle 1 DLTs were observed in <33% in at least 12 participants.
735405|NCT01441401||
735406|NCT01441245|Department of Internal Medicine, Cardiology Section Centre into a Para-Intensive Unit (Siena, Italy) from April 2011 to December 2012.|22 were excluded because of normal renal function at baseline, 11 for receiving different dosages of intravenous furosemide, 4 for isolated diastolic HF
735407|NCT01441180||
735408|NCT01441102|Five participant study; however, up to an additional three participants may be enrolled to account for participants who withdraw from the study prior to receipt of six months of study treatment.|
735409|NCT01441076||
735410|NCT01441063||
735411|NCT01441037||
735412|NCT01440972||
735413|NCT01440959|Between September 2011 and April 2012, a total of 30 patients with metastatic and/or unresectable GISTs who had treatment failure with imatinib and sunitinib were enroled in Asan Medical Center, Seoul, Korea.|There are no specific approaches between enrollment and treatment.
735414|NCT01440946||
735415|NCT01440881|Starting in June 2010 and ending in December 2012, subjects were seen in outpatient clinics or in the hospital. The pre-operative labs were used to screen and enroll subjects.|Out of the 37 signed informed consent there were 8 subjects who were consented and did not participate: 2 subjects changed their mind, 5 subjects creatinine level was not within the protocol level for participation, 1 subject surgery was canceled. This left 29 subjects to participate in the study.
735416|NCT01440816|Participants were enrolled at 1 investigative site in the United States from 03 January 2012 to 10 April 2015.|
735417|NCT01440803||"Periods have been added to represent the sequential nature of the study (e.g., Period 1: Double blind Forteo/Placebo, Period 2: Double Blind Forteo/Forteo, Period 3: Open Label Forteo, etc.) per PRS."
735418|NCT01440764||This was a crossover study of a total of 24 people.
735419|NCT01440647||
735420|NCT01440634|Patients were recruited at community centers. Enrollment was performed between february 2008 and June 2011.|Patients that denied to be randomized and/or to follow the schedule for the research procedures was excluded of the study.
735421|NCT01440595||No participants were randomized to the Grazoprevir 800 mg + Peg-IFN + RBV arm.
735422|NCT01440569|Participants were enrolled at a total of 56 study sites in the United States. The first participant was screened on 22 September 2011. The last study visit occurred on 30 October 2015.|397 participants were screened.
735423|NCT01440543|"recruitment process between January and June 2011
~outpatients referred to our endoscopy unit for diagnostic colonoscopy"|"a total of 548 patients were assessed for eligibility
~a total of 420 patients were randomized after exclusion of 128 subjects because of not fulfilled inclusion criteria
~a total of 404 patients were analyzed after exclusion of 16 subjects (poor bowel preparation, IBD, argon plasmacoagulation, endoscopic resection or malignant obstruction)"
735424|NCT01440517||
735425|NCT01440452||
735426|NCT01440387||
735427|NCT01440374|"Part 1, 17 subjects received open-label eltrombopag. Part 2, 145 subjects were randomized to receive eltrombopag plus SOC (N=98) or placebo plus SOC (N=47).
~Part 3, 59 subjects from Part 2 entered Part 3. SOC was allowed as needed throughout the study. Subjects could receive disease-modifying therapy as needed."|Participants with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) and Grade 4 thrombocytopenia due to bone marrow insufficiency and had at least one of the following: platelet count <10 Giga cells per liter, platelet transfusion or symptomatic hemorrhagic event during the 4 weeks prior to enrollment, were enrolled in the study.
735428|NCT01440322|Participants were recruited from 10 investigational centers located in the United States.|Of the 150 participants enrolled, 3 were exited from the study as screen failures prior to study product dispense. This reporting group includes all randomized and dispensed participants (147).
735429|NCT01440283|Fourteen participants were enrolled on the study between September 2011 and July 2013.|
735430|NCT01440101||This was a 2-part, multicenter study, each part (open-label, double-blind) comprising discrete cohorts of BG00002-naïve participants.
735431|NCT01440049||
735432|NCT01439971||This was an open-label study to characterize the single dose pharmacokinetics (PK), pharmacodynamics, safety, and tolerability of 5 intravenous dose levels of PF-05280602 (0.5, 4.5, 9.0, 18.0 and 30.0 micrograms/kilogram [mcg/kg]).
735433|NCT01439945||After the double blind phase patient were allowed to re-registered on the Optional Continuation Phase of the study. This phase lasted up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.
735434|NCT01439880|"This extension study was conducted at 188 centers in 18 countries. Participants were enrolled from one of five eligible phase 2 parent studies: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703).
~Participants were enrolled from October 2011 to June 2013."|Participants were randomized in a 2:1 ratio, irrespective of their treatment assignments during the phase 2 parent study, to either evolocumab plus standard of care (SOC) or SOC alone. Randomization was stratified by the treatment to which the participant was randomized to in the parent study, ie evolocumab or control.
735435|NCT01439867|The study was conducted at 14 study centers in Czech Republic (1 site), France (1 site), Germany (1 site), Italy (1 site), Slovakia (1 site), Poland (3 sites), and the United States (6 sites). The first participant was enrolled on 22 June 2012, and the last participant completed the study on 03 June 2016.|Because of changes to the study design that were implemented after the partial clinical hold, data are presented overall and for 2 cohorts: participants enrolled before the partial clinical hold (Cohort 1) and participants enrolled after the partial clinical hold (Cohort 2).
735436|NCT01439854||
735437|NCT01439724||
735438|NCT01439711||
735439|NCT01439672||
735440|NCT01439633||
735441|NCT01439620||
735442|NCT01439594||
735443|NCT01439581||
735444|NCT01439568||Participants who died (any cause) or had disease progression were considered to be study completers.
735445|NCT01439555||
735446|NCT01439373|Participants were enrolled at 5 sites in the United States. The first participant was randomly assigned to study drug on 20 July 2011 and the last participant completed the study on 05 December 2011.|A total of 16 participants were enrolled and randomly assigned to study medication. One participant with genotype-1 who was randomly assigned to study medication withdrew before receiving the first dose and was not included in any of the analysis populations.
735447|NCT01439360||Out of the 12046 enrolled subjects, 21 subjects were excluded from all statistical analyses due to an invalid informed consent form (ICF) and 7 subjects did not receive any study vaccine despite being allocated a subject number, hence only 12018 subjects started this study.
735448|NCT01439282||
735449|NCT01439204|10 October 2011 to 11 Feb 2012. Participants who were randomized to an arm were admitted to a clinical facility the day prior to dosing (Day -1) and confined until 24 hours post the single dose; participants followed to Day 71.|Healthy participants who weighed between 60 and 100 kilograms, inclusive. 223 enrolled; 72 randomized to an arm. Reasons for not being randomized: 24 withdrew consent, 5 poor/non-compliance, 111 no longer met study criteria, 11 other. Participants were age and sex matched between treatment arms.
735450|NCT01439165|Study participants were enrolled from 30 November 2011 to 13 August 2015 at 31 clinic sites in the United States and 2 clinic sites in Canada.|A total of 1330 participants who met all inclusion criteria and no exclusion criteria were randomized; 1327 participants were vaccinated.
735451|NCT01439126|The study was conducted at 34 sites in the US. First patient was enrolled on September 8, 2011 and last patient completed on October 29, 2012|The study population included male or female subjects 6 to 17 years of age, who met the Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV-TR) criteria for Attention Deficit Hyperactivity Disorder (ADHD).
735452|NCT01439087||
735453|NCT01439074||
735454|NCT01439035||
735455|NCT01439009||
735456|NCT01438996|First subject enrolled: 17 OCT 11, Last subject completed: 13 DEC 11.|
735457|NCT01438840||A total of 100 participants were screened in study. Of these 100 participants, 51 were screen failures and 49 were randomized into the study.
735458|NCT01438814||
735459|NCT01438710||
735460|NCT01438541|The recruitment period was from 03 October 2011-21 February 2012. The study was conducted at three wound care units in United Kingdom.|There was no wash-out or run-in phase included in the study.
735461|NCT01438489||A total of 626 participants were screened out of which 319 participants did not meet eligibility criteria and were considered screen failures, and 307 participants were randomized into the study.
735462|NCT01438476|During the study period, 178 screened patients were initially eligible for inclusion to the randomized controlled trial.|Among the 178 eligible patients, 38 patients were excluded due to withdrawal of consent, development of exclusion criteria and/or the finding of unresectable disease at surgery. The study concluded with 140 patients eligible for analysis, with 106 patients allocated to the TEA group and 34 patients allocated to the IV-PCA group.
735463|NCT01438424||Of 1053 participants enrolled, 1051 received treatment.
735464|NCT01438411|"This study included subjects with inborn errors of bile acid metabolism who had previously participated in studies CAC-91-10-10 or CAC-001-01 as well as newly diagnosed subjects.
~Data were collected from 1 Jan 2010 through study completion on 31 Jul 2016. Note that treatment with cholic acid continues throughout a subject's lifetime."|Of 53 subjects, 31 subjects rolled over from studies CAC-91-10-10 and/or CAC-001-01, while 22 patients were treatment-naive, i.e. received their first dose of cholic acid during study CAC-002-01.
735465|NCT01438307|Subjects will be randomized to one of two schedules (A or B) each with a specified dosage and administration schedule. A two stage design will be used for each of the two schedules. Fourteen subjects will be accrued for each schedule in Stage I with an additional 34 subjects in Stage II per schedule depending upon the first stage results.|New approaches are needed for 2nd line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in metastatic prostate cancer and it is hopeful to do the same in advanced Non-Small Cell Lung Cancer (NSCLC).This phase II study will evaluate the efficacy of cabazitaxel chemotherapy in 2nd line setting in patients with NSCLC.
735466|NCT01438294|Children were randomly allocated to either video game (VGG) or treadmill training (TG) group. 2 sealed envelopes were prepared for each participant, each envelope corresponded to one of the study groups and the envelope was drawn for each participant by the researcher after the baseline measurements have been performed.|Ten children (7 VGG/3 TG) withdrew from the study: 4 due to changes in the school schedule, 3 abandoned without explanation, 2 due to difficulties in the parents schedule and 1 that moved to another city. Twenty-six patients completed the study (13VGG/13TG).
735467|NCT01438229||
735468|NCT01438177|From Oct. 2011 to March 2013, 11 patients were enrolled to the study from New York University Langone Medical Center.|
735469|NCT01438151|11 patients were recruited between 2/16/12 and 10/18/12. Patient were recruited either during inpatient hospitalization or outpatient visit for Remicade.|
735470|NCT01438060|232 participants were enrolled, 24 were not randomized (baseline failures).|
735613|NCT01430403|Eight National Institute of Allergy and Infectious Diseases (NIAID) Inner-City Asthma Consortium (ICAC) sites in the United States recruited the targeted number of study participants who fulfilled entry criteria. Recruitment occurred September 2011 to March 2014.|
735471|NCT01438008|Between June 2012 and September 2015, 73 infants admitted in the NICU were assessed for eligibility, 50 (69%) were ineligible, of the 23 (32%) infants that were approached, 7 (3%) declined to participate, 16 (70%) provided consent.|Consent was obtain for 16 infants to participate, 7 (44%) were not randomized (prior to data collection n=3 infants were weaned off fentanyl, n=3 infants were discharged/transferred, n=1 medical team refused). 9 (12%) infants were randomized. 4 infants were allocated to sucrose and 5 infants were allocated to water.
735472|NCT01437995||Enrolled participants were enrolled in an 8-week open label treatment run-in and were subsequently randomized only if their asthma remained stable (i.e. an ACT score ≥ 20 at weeks 4 & 8, no unscheduled healthcare encounters, no change in asthma medication, pre-bronchodilator FEV1 ≥ 70% predicted, and limited use of rescue beta-agonist).
735473|NCT01437943|10 subjects were recruited into the trial however none completed the treatment/follow-up as Novartis terminated all studies involving Aliskiren.|
735474|NCT01437878|Patients were screened at 4 centres in the US, one centre in France, and one site in Spain. First patient, first visit was 1 March 2012 and last patient, last visit was 30 November 2012.|A total of 22 patients were screened for the study, of these 20 were not randomized because they did not meet the selection criteria.
735475|NCT01437852|The study evaluated the safety and efficacy of StrataGraft skin tissue in promoting the healing of deep partial-thickness burns. Subjects had surgical excision and placement of StrataGraft skin tissue and autograft. The trial was conducted at six clinical sites throughout the United States.|All subjects were treated with both StrataGraft skin tissue and autograft as part of the intrapatient comparator design. Two comparable excised areas of deep partial-thickness burn per subject were randomized to receive a single application of autograft or StrataGraft skin tissue.
735476|NCT01437605||
735477|NCT01437540|"The study was conducted at 127 centers in the United States
~The first patient was screened in September 2011 and the last patient visit was in March 2013"|"The study consisted of a 2- to 3-week run-in period designed to assess the stability of patients' disease and establish each patient's baseline characteristics
~1063 patients were screened for eligibility; 473 were considered screen failures (main reason [406/473] inclusion/exclusion criteria not met)"
735478|NCT01437501|1205 Individuals were recruited from HeHe Township in Qidong, PRC for eligibility screening at 3 medical clinics within the township in September 2011.|
735479|NCT01437488||
735480|NCT01437449||
735481|NCT01437423|Study participants were enrolled for a 6 year surveillance period (31 August 2009 to 30 August 2015) at 8 clinic centers in Korea.|Of the 662 participants whose case report forms were retrieved, 647 participants were included in the safety analysis.
735482|NCT01437397|This study was conducted at 205 sites, 178 in the United States, 9 in Canada, 10 in Australia, and 8 in New Zealand. The first patient was screened in October 2011 and the last patient visit was in February 2013|A total of 3260 patients were screened for eligibility; 1692 patients were randomized to treatment. A total of 1568 (48.1%) patients screen failed and were discontinued prior to randomization. The primary reason for screening failures was not meeting inclusion/exclusion criteria (41.6%)
735483|NCT01437319|289 Subjects were enrolled in the study. 7 subjects did not meet the eligibility criteria. 282 subjects entered Phase I. During Phase I, 55 subjects were either lost to follow-up or discontinued. The remaining 227 subjects were randomized to either comfilcon A or balafilcon A and entered Phase II. 146 subjects completed Phase II|During Phase I, subjects are classified as either repeated Mucin Ball former or Non-Repeat Mucin Ball former. The 227 subjects that entered Phase II kept there Mucin ball classification, but were still randomized to either comfilcon A or balafilcon A. All comparisons are made between Mucin Ball classification
735484|NCT01437267||
735485|NCT01437124||
735486|NCT01437111||
735487|NCT01437098||
735488|NCT01436799|March 2011-August 2011 in Gachon University Gil Medical Center, who underwent arthroscopic shoulder surgery|no enrolled participants were excluded.
735489|NCT01436643|The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant|
735490|NCT01436526|All participants (part.) recruited by CRS Clinical-Research-Services Moenchengladbach GmbH, Hindenburgstrasse 304 - 306, 41061 Moenchengladbach, Germany. 28 part. were planned to be enrolled.|37 participants screened; 9 participants were screening failures; 28 participants were included in the study. Safety analysis: 27 individuals were analyzed in the group with 2*5mg, 27 individuals were analyzed in the group with 1*10mg.
735491|NCT01436500||
735492|NCT01436435||
735493|NCT01436396|Study participants were enrolled from 07 September 2011 to 08 March 2012 at 2 clinical sites (1 in Colombia and 1 in Peru).|A total of 792 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized; 787 participants were vaccinated.
735494|NCT01436370|Adults with rheumatoid arthritis (RA) receiving tumor necrosis factor (TNF)-alpha-inhibitor therapy and healthy controls were recruited from existing volunteer populations and the community around the clinical site. Participants were enrolled between 20OCT2011 - 3JAN2012 (2011-2012 vaccine); and 12SEP2012 -14JAN2013 (2012-2013 vaccine).|
735495|NCT01436357|People who are actively injecting drugs who are at high risk for HCV infection, negative for HCV antibodies and HCV RNA at screening, were recruited at 3 clinical sites experienced in recruiting and retaining people who inject drugs in prospective studies. Participants were enrolled between 19MAR2012 and 28OCT2016.|
735496|NCT01436305|Three sites in the United States enrolled a total of 19 participants in the study.|
735497|NCT01436279||
735498|NCT01436266|Eligible women will be identified by the clinician caring for the patient who will mention the study. If interested research staff will describe the study in detail and obtain consent from interested patients. The clinician who cares for the patient, and the physician who does the abortion procedure, will not be involved in the research procedures.|Three subjects were consented, one of which was ineligible after consent because she had spontaneous rupture of amniotic membranes prior to the abortion procedure. The other two subjects were enrolled.
735499|NCT01436253||
735500|NCT01436201||
735501|NCT01436175|Study enrolled eligible adults with major depressive disorder (MDD) who had completed treatment in a short-term antecedent SPD489 (lisdexamfetamine dimesylate) MDD study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|
735504|NCT01436110||Participants meeting eligibility criteria at the Screening visit entered a 2-week Run-in Period for Baseline safety evaluations and to obtain measures of asthma status. Participants were then randomized to a 24-week Treatment Period. A total of 655 participants were screened; 351 were randomized, and 347 received >=1 dose of study treatment.
735505|NCT01436084|Recruitment Period: December 22, 2011 to January 24, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Four participants of the eight enrolled failed to meet the screening criteria and were not treated on the study. The study was closed to new patient entry 2 months after activation due to sponsor/collaborator issues; the only patient remaining was taken off study at that time.
735506|NCT01436071||Participants meeting eligibility criteria at the Screening visit entered a 2-week Run-in Period for Baseline safety evaluations and to obtain measures of asthma status. Participants were then randomized to a 12-week Treatment Period. A total of 449 participants were screened; 248 were randomized, and 242 received >=1 dose of study treatment.
735507|NCT01436045||
735508|NCT01436006||
735509|NCT01435928||
735510|NCT01435824|"Healthy young adults were enrolled. 16 individuals were assessed and randomly assigned to either water-based first, then milk-based amoxicillin administration or milk-based first and then water-based administration arms. The washout period was 1-2 weeks. The study was conducted at Hospital for Sick Children in Toronto, Canada."|Participants were interviewed and underwent basic vital sign checking, and filled health status questionnaire to declare lack of any significant medical conditions. Urine pregnancy tests, with consents, were performed before dosing for female participants.Wash-out period between water and human milk phases was 1-2 weeks.
735511|NCT01435798|Subjects were recruited nationally from referring physicians, through advertisements, and through existing databases.|During the screening visit, P450 2D6 phenotype status was determined for each subject to identify drug-metabolizing capacity; those who were P450 2D6 poor-metabolizers were excluded. Following screen, each subject entered a dose escalation period to determine his/her maximum tolerated dose (MTD), prior to randomization.
735512|NCT01435772||
735513|NCT01435759||
735514|NCT01435655||
735515|NCT01435616||
735516|NCT01435603||Potential participants were prescreened on the phone and attended a baseline visit for further screening and enrollment.
735517|NCT01435577|The recruitment period for this trial was from the 26 September 2011 and was completed on the 14 Feb 2012.|"177 participants signed informed consent.
~132 participants underwent surgery.
~131 participants reported a pain intensity that qualified them to enter the trial, i.e. one participant did not report sufficient pain to enter the trial.
~129 participants were randomized to receive treatment."
735518|NCT01435512||
735519|NCT01435460|Three hundred participants were enrolled in the study. First participant was enrolled 08/03/2010, last participant exited on 04/26/2011. This study was conducted at 7 sites in China.|Three hundred participants were randomized into two groups, 151 to be treated with Alrex and 149 to be treated with Patanol.
735520|NCT01435382||
735521|NCT01435356|83 patients were randomised, 52 for recMAGE-A3 +AS15 and 31 for placebo treatment. 6 patients did not start treatment due to ineligibility (4 for recMAGE-A3 +AS15 and 2 for placebo treatment).|
735522|NCT01435304||
735523|NCT01435265||
735524|NCT01435174||
735525|NCT01435122|Participants were enrolled at H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida and the UCSF Comprehensive Cancer Center, University of California, San Francisco, California, from October 2011 through January 2014.|
735526|NCT01435031|A total of 250 subjects were enrolled in 20 sites from September 13, 2011 to February 7, 2013. Twenty-eight participants were excluded from ITT (N=222) in whom recanalization and pre-dilatation of the target lesion were not completed and/or study stent was not inserted into the coronary guiding catheter.|ITT set included 222 subjects who met entry criteria, were enrolled in the trial and whose target lesion was successfully crossed and predilated. PP set included all ITT subjects (N = 183) in whom at least 1 study stent was implanted,met procedure success,had follow-up data and had no major protocol deviations due to inappropriate enrollment.
735527|NCT01435018|Participants were recruited from October 2013 to March 2018 at 11 sites from Africa and South America (Brazil).|
735528|NCT01434823|We enrolled all patients admitted to the medical ICU (MICU) service at the Hospital of the University of Pennsylvania for one year from September 12, 2011, to September 11, 2012. In-hospital follow-up was conducted for an additional 90 days.|Exclusions included patients who were readmitted to the ICU within the same hospitalization (we included their first ICU admission), patients who were admitted during the holiday block (no nighttime coverage), and patients who had ICU stays so brief they were either were not exposed to nighttime hours or ineligible for APACHE score calculation.
735529|NCT01434810||
735530|NCT01434745|Only one participant enrolled|
735531|NCT01434693|A total of 8 clinical sites were initiated, all in the United States, with 6 of these sites enrolling at least one patient. Patients were enrolled from Nov, 2011 to Jan 30, 2012.|All patients were immediately assigned to a treatment group upon enrollment.
735532|NCT01434680|Subjects were enrolled at eleven sites in Poland.|All enrolled subjects were included in the trial. Data from the group MenC-CRM ROS_EMV was not included in the primary and secondary analyses as these subjects were initially enrolled in group MenC-CRM ROS, but wrongly vaccinated with MenC-CRM EMV.
735533|NCT01434667||"32 enrolled participants were not assigned for the reasons that follow:
~Ineligible (n=7)
~No study partner: 5
~Diagnosis was not amnestic mild cognitive impairment (MCI): 1
~Low cognitive score: 1
~Declined to continue (n=17)
~No longer interested: n=11
~Too busy: 4
~No reason given: 2
~Lost to follow-up (n=8)"
735534|NCT01434654|Participants were recruited from St Vincent's Hospital and/or referred from tertiary sexual health centres over the period January 2012 to June 2013.|
735535|NCT01434641|102 consecutive patients referred for clinically indicated myocardial perfusion SPECT were recruited.|
735536|NCT01434511||
735537|NCT01434342|Participants are recruited from NCI CCOP sites|
735538|NCT01434290||
735539|NCT01434186||Of 32 subjects enrolled, 7 subjects entered the lead-in period. Of these 7 subjects, 6 were randomized
735540|NCT01434121||
735541|NCT01434030||
735757|NCT01421459||
735758|NCT01421355||
735545|NCT01433549|Participants were recruited from one study center located in Canada.|Of the 44 participants enrolled, 16 were exited from the study prior to randomization (screen failures). Three subjects were randomized/fitted with lenses but discontinued prior to product dispense. This reporting group includes all participants enrolled and dispensed product. A 12-hour lens-free wear period preceded each phase.
735546|NCT01433471||
735547|NCT01433354|The study was conducted at 28 centres in 13 countries.|A total of 120 patients were enrolled, of which 119 received the study medication. Category 1 patients received AFQ056 in the core study and enrolled in the extension within 7 days of the core study; Category 2 included all other patients who were enrolled into the extension study
735548|NCT01433263|Core Phase single dose BYM338 30mg/kg i.v. active or placebo with 8week followup. Followup phase started Week 8 & patients on placebo in the Core Phase were given BYM338 & patients on BYM338 in Core Phase continued to be followed for an additional 8 weeks. Late BYM338 are patients who received Placebo during Core Phase and then BYM338 after Week 8.|
735549|NCT01433250||
735550|NCT01433172|Participants were enrolled at Moffitt Cancer Center between April 2012 and June 2015.|Three participants were enrolled in the Phase I portion of the study, followed by seventy participants enrolled in the Randomized Phase II portion of the study.
735551|NCT01433159|Subjects >/= 12 yrs of age with Stage I or II pressure ulcers between 1 and 100 cm2 (inclusive) in total aggregate area and maintaining an adequate nutritional status and were receiving a full caloric diet, either orally or by tube|
735552|NCT01433107|Study start 27 Aug 2011 end 14 Feb 2012|Each particiapant received a single dose of Terbinafine Film Forming Solution 1% or matching placebo
735553|NCT01433081|Patients were enrolled consecutively from 2/2011 through 4/2013.|
735554|NCT01433055||
735555|NCT01433042|All patients enrolled in this study were indicated to undergo SB capsule endoscopy and/or had symptoms suggestive of SB disease. 225 patients were enrolled in this study recruitment period: August 2011 till September 2012. recruitment performed at Gastroenterlogy clinics and departments|"After obtaining the consent, subjects were assessed for eligibility to participate based on the eligibillity criteria. Each patient underwent a PillCam SB3 procedure. Preparation for the procedure included a 12 hours fast prior to the PillCam SB3ingestion.
~Patients were allowed to drink clear liquids 2 hours and eat 4 hours post ingestion."
735556|NCT01433016||
735557|NCT01432951||Participants who were considered to have completed the study who received at least 1 dose of study drug and from whom a valid assay result was obtained.
735558|NCT01432938||
735559|NCT01432886||
735560|NCT01432756||
735561|NCT01432730|24 participants were enrolled and randomized from a single center.|
735562|NCT01432626||
735563|NCT01432600|Between December 2011 and March 2014, participants were enrolled at: H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY.|
735564|NCT01432574|HIM Study participants that met the eligibility criteria were invited and enrolled into this Phase II Trial at the US and Mexico clinical sites between February and October of 2013.|
735565|NCT01432561|Recruitment period: 09/19/2011 - 11/21/2012 Recruitment Locations: medical centers|Screening for liver function and H pylori infection and brief medical history in order to determine if all inclusion and exclusion criteria were met. One enrollee met all inclusion criteria but clinical lab test revealed presence of H Pylori, an exclusion factor. Two enrollees withdrew from the trial prior to assignment due to scheduling conflicts.
735566|NCT01432535||
735567|NCT01432457|Subjects were recruited in the United States from October 2011 to May 2012.|Subjects were screened up to 2 weeks.
735568|NCT01432444|This study assessed hospitalization rates in adults with schizophrenia treated prospectively for 6 months with aripiprazole intramuscular depot compared with 6 month retrospective treatment with oral antipsychotics. The study comprised 3 phases: Tolerability/Cross-titration (Phase A), Open-label Aripiprazole (Phase B), Extension (Phase C).|493 participants were enrolled, 325 of which had no history of tolerating oral aripiprazole entered Phase A, all participants completed Phase A combined with remainder of participants to enter Phase B. All outcome measures were assessed in Phase B.
735569|NCT01432405||
735570|NCT01432379||
735571|NCT01432366||
735572|NCT01432327|August 2010 - May 2010: recruitement of employees. Method: flyering at Pharmacists, word of mouth, information session at companies in and around the region of Antwerp|Students and seniors were excluded from the study. Participants with an average Physical Activity Level above 1.71 times their resting metabolic rate were excluded from the trial
735573|NCT01432275|A total of 179 subjects were enrolled on this study, 164 completed the study.|One subject was excluded due to not meeting all inclusion criteria, one subject withdrew before randomisation.
735574|NCT01432262||
735575|NCT01432236|In this double blind, crossover study, a total of 197 participants were randomized to either pregabalin/placebo or placebo/pregabalin treatment sequence. Of these, 193 took at least one dose of study medication. Four randomized participants never took study medication. Randomized participants were recruited from 4 countries at 38 study centers.|Participants with mean Numeric Rating Scale (NRS) pain score of ≥4 at Baseline and meeting all other inclusion/exclusion criteria were randomly assigned to receive double blind treatment with either pregabalin followed by placebo with background antidepressant or placebo followed by pregabalin with background antidepressant.
735576|NCT01432171|Recruitment Period: July 25, 2012 to May 23, 2016. All recruitment done in medical clinical settings.|
735577|NCT01432145|74 patients were consented and registered from 14 sites between May 2011 and October 2014, and 67 of these registered patients were found to be evaluable. This is larger than the planned sample size of 65 patients, to compensate for unevaluable patients.|No wash out or run-in periods. No enrolled participants were excluded from the study before assignment.
735578|NCT01432015||
735579|NCT01431989||This is a prospective, open-label, randomized, crossover, single-dose study in which two different treatments (Test Product versus Reference Product) were administered in two sequences in two study periods. The objective was to confirm if two formulations of Amoxicillin trihydrate, in the form of powder for oral suspension, are bioequivalent.
735759|NCT01421342||
735760|NCT01421303||
735580|NCT01431976|Participants with newly diagnosed and untreated typical absence seizure; aged 2-15 years in Japan, 2-12 years in South Korea at the time of obtaining consent; weighing at least 7 kilograms (kg); without partial seizure or generalized seizures other than typical absence; and without a history of rash associated with other treatment were enrolled.|The study consisted of an Escalation Phase (EP), a 12-week (W) Maintenance Phase (MP), a >=2-week Taper Phase, and post-study examination within 1-4 weeks after the last dose of lamotrigine. Participants could have entered the Extension Phase (ExP) until approval for this indication or until 24 months after the Last Subject Last Visit in the MP.
735581|NCT01431963|A total of 70 participants were enrolled; 3 participants were screened but withdrew from the study before prescription of the first investigational product (67), and only 65 of the participants received at least one dose of the investigational product which comprised the safety population.|The study consisted of a 6-week Escalation Phase, a 24-week Maintenance Phase (MP), a >=2-week Taper Phase, and a post-study examination conducted within 1-4 weeks after the last dose of lamotrigine. In Japan only, the Extension Phase was conducted until either approval for this indication or after 24 months after Last Subject Last Visit in the MP.
735582|NCT01431950||Participants meeting eligibility criteria at the Screening visit entered a 4-week Run-in Period for Baseline safety evaluations and to obtain measures of asthma status. Participants were then randomized to a 24-week Treatment Period. A total of 500 participants were screened; 239 were randomized, and 238 received >=1 dose of study treatment.
735583|NCT01431846||
735584|NCT01431794|10 subjects were screen failures. All of 13 subjects were enrolled into the Arm/group: Phase I: gem, nab-paclitaxel, and LDE225-600mg. Other Arm/group did not enroll any subjects due to early termination of the study.|
735585|NCT01431755|First subject enrolled: September 10, 2011 Last subject visit: October 19, 2012|The study has split-face design. Each subject is randomized to treatment with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek.
735586|NCT01431716|Patients were enrolled at eight centers in the European Union and Canada. First patient, first visit was 15 March 2011 and last patient, last visit was 2 February 2012.|Patients must have been treated with Flolan for at least 12 months and on a stable dose for at least 3 months prior to enrollment. There was a screening period of up to 14 days.
735587|NCT01431703||
735588|NCT01431534||
735589|NCT01431521|"Thirty-one male or female participants (non-childbearing potential) between the ages of 18 and 60, inclusive, with body mass index (BMI) ≥ 32 kg/m^2 were enrolled in the study. Participants were pre-screened by means of ultrasound, and only those participants with a rating of moderate or severe steatosis were further evaluated by means of MRI."|
735590|NCT01431508||
735591|NCT01431391||
735592|NCT01431339||
735593|NCT01431313|Subjects were enrolled in the trial between June 2012 and October 2017.|
735594|NCT01431300||
735595|NCT01431287||This trial was one of 2 confirmatory Phase III 52-week, multi-centre, multi-national, randomised, double-blind, parallel group studies to evaluate the long-term efficacy and safety of once daily treatment with orally inhaled Tio+Olo FDC (2.5/5μg; 5/5μg) compared with the individual components (2.5μg; 5μg Tiotropium, 5μg Olodaterol) in COPD patients
735596|NCT01431274||This trial was one of 2 confirmatory Phase III 52-week, multi-centre, multi-national, randomised,double-blind, parallel group studies to evaluate the long-term efficacy and safety of once daily treatment with orally inhaled Tio+Olo FDC (2.5/5μg; 5/5μg) compared with the individual components (2.5μg; 5μg Tiotropium, 5μg Olodaterol) in COPD patients
735597|NCT01431170||
735598|NCT01431144|27 patients were entered, 13 for the test allograft group and 14 for the positive control connective tissue autograft group|There were no exclusions prior to assignment or treatment.
735599|NCT01431131|The study was conducted between September 2011 and July 2012 in the Graduate Periodontics clinic at the University of Louisville School of Dentistry.|
735600|NCT01431105||
735601|NCT01431079|"Recruitment for Phase I of the study was conducted between Oct. 2011-Nov. 2011 at the University of Cincinnati. Snowball sampling was done (n=50).
~Phase II occurred between March 2012-April 2012 at the University. A snowball sample was used. 90 participants were recruited. A post test was done immediately after the intervention."|
735602|NCT01431014||
735603|NCT01430819|Study participants were enrolled from 07 September through 24 October 2011 in 6 clinic sites in the US.|A total of 300 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
735604|NCT01430754||Patients who met the I/E criteria were treated with tasimelteon 20 mg for 6 wks during run-in. Entrained patients were randomized to tasimelteon 20 mg or placebo for the remainder of the study.
735605|NCT01430741||All case managers were invited to participate and verbally consented before randomization into the IU or the GTO group. 10 refused to participate.
735606|NCT01430624||
735607|NCT01430611|The study participants were enrolled from 23 August 2011 to 12 October 2011 at a single center in China.|A total of 665 of the 666 participants who met all of the inclusion and none of the exclusion criteria that were randomized were vaccinated in this study.
735608|NCT01430585||Due to premature termination of the study, the planned treatments of Phase 2, PF-04691502, then PF-04691502 + Letrozole (Phase 2), PF-04691502 + Letrozole (Phase 2) and Letrozole (Phase 2), were not administered.
735609|NCT01430559|A total of 24 centers in mainland China recruited study participants, starting from 24 Oct 2011 to 14 Dec 2012.|This study comprised of a Screening Period prior to Treatment Period. During Screening, 52 healthy participants and 356 participants with osteoarthritis (OA) were included in validation analysis set (total enrollment=408), 293 out of the 356 OA participants were assigned randomized to treatment, and 6 of these randomized participants did not receive actual treatment.
735610|NCT01430468||
735611|NCT01430455||
735612|NCT01430442|The study was conducted at 41 centers in the United States. A total of 1026 participants were enrolled in the study, and 885 of these were randomized to treatment. Of the 141 participants who were not randomized, the main reason for non-randomization was participants no longer met inclusion criteria.|The study was divided into 3 phases: a screening/baseline phase (3-28 days), an acute treatment phase (up to 45 days during which participants were treated on 1 migraine headache of moderate to severe intensity), followed by an end-of-treatment visit within 7 days of administration of study drug.
735614|NCT01430325|82 individuals responded to study announcements and were pre-screened by telephone, of which 25 were deemed ineligible (due to inadequate diving experience). An additional 15 individuals declined to participate (primarily due to scheduling conflicts). 42 divers and chamber inside attendants signed informed consent and participated in the study.|All participants signing informed consent continued to group assignment.
735615|NCT01430299||
735616|NCT01430182|Subjects were inpatients in Ben Taub General Hospital, a General and Teaching Hospital in Houston, Texas. Subjects were enrolled from October 2011 through May 2013.|18 subjects were approached for participation. 1 was a screen failure, yielding 17 subjects who were randomized and received methadone or morphine
735617|NCT01430169||
735618|NCT01430130|All procedures were performed at a single outpatient surgery clinic between September of 2011 and May of 2012.|
735619|NCT01430104||
735620|NCT01430091||
735621|NCT01429987||
735622|NCT01429792|Male and female participants, 18 years of age and above with serologically proven genotype 1, 2, 3 or 4 CHC and treated with the standard combination treatment of peginterferon alfa-2a (Pegasys) and ribavirin (Copegus).|A total of 1013 participants were enrolled in the study and 607 of them completed the study.
735623|NCT01429623|Recruitment between Feb. 17, 2012 and August 1, 2013.|
735624|NCT01429584||
735625|NCT01429532|This prospective randomized study included 120 patients (120 eyes) with age-related cataract enrolled between July 2010 and January 2011 at the Zhong-shan Ophthalmic Center, Guangzhou, China.|Potential subjects with previous intraocular surgery, glaucoma, pseudoexfoliation, uveitis, high myopia and diabetes mellitus were excluded from participation in the study.
735626|NCT01429454||
735627|NCT01429441|This study was conducted at 25 study sites in the United States. The first subject was enrolled on 02 November 2011 and the last subject completed the study on 22 October 2014.|
735628|NCT01429350||
735629|NCT01429298||
735630|NCT01429285||
735631|NCT01429272||
735632|NCT01429259||
735633|NCT01429077||
735634|NCT01429064|Participants were enrolled at 17 hospitals in Europe and in the USA|Patients with response or stable disease at week 12 in ARADES 3104001 study as judged by the investigator, were allowed to continue in the ARADES-EXT 3104002 extension study.
735635|NCT01429051|Participants took part in the study at 11 investigative sites in Hungary, Norway and Russia from 08 August 2011 to 04 January 2013.|The first dose of Intranasal Fentanyl Spray (INFS) was taken at the clinic for training purposes and was not related to treatment of a BTP episode. One patient received the initial 50 μg test dose but did not receive INFS for titration, but is included in the safety analysis set.
735636|NCT01428882||
735637|NCT01428765||
735638|NCT01428713|Post-menarchal young girls </= 21 years of age with menorrhagia or menometrorrhagia, referred to hematology or gynecology clinics at Texas Children's Hospital (TCH) formed the study population.|The study design employed was a randomized crossover trial comparing the use of oral TA formulation Lysteda and the COCP formulation Lo/Ovral. Patients were randomized to one of two treatment groups, group A versus group B. Patients who were already on COCP underwent one cycle washout prior to randomization.
735639|NCT01428661||"*Tasi: subject left country (1); Placebo: sponsor request (1), subject moved (1), IMP schedule (1), subject incarcerated (1), withdrawn after receipt of medical records (1), visit schedule (1)
~**Tasi: surgery (1), visit schedule (3), +UDS (2), IMP schdule (2), prohibited meds (1), withdrew consent (1), sponsor terminated trial (175)"
735640|NCT01428583||
735641|NCT01428453|Participants with Alzheimer's disease (AD) were randomized to either rilapladib or placebo from October-2011 to February-2013. The study duration was approximately 30 weeks (screening: 4 weeks, treatment: 24 weeks and follow-up: 2 weeks).|Total of 170 participants were screened, of which 124 were randomized in 24 centres. Out of 124 participants, one was excluded from safety population due to randomization error. Out of 123 participants, 2 were excluded due to unavailability of post-baseline efficacy data. Intention to treat (ITT) population consisted of 121 participants.
735642|NCT01428336||
735643|NCT01428258||
735644|NCT01428245||3 subjects enrolled in this study. 2 subjects completed screening procedures only (these 2 subjects were withdrawn from study prior to being assigned to an arm of intervention).
735645|NCT01428219||
735646|NCT01428193||
735647|NCT01428128|Recruitment took place from April 2011 to November 2012. Patients were recruited from Medical Oncology clinic and due to receive standard of care chemotherapy.|No baseline p52 activation in peripheral lymphocytes in culture, but p53 activation inducible upon radiation in culture.
735648|NCT01428115||
735649|NCT01428076||
735650|NCT01428063|The study was conducted at 92 centers in 20 countries.|A total of 276 participants were enrolled, 228 were randomized and 227 received treatment. Participants were not treated because they no longer met study criteria (n=41), withdrew their consent (n=4), showed poor/non-compliance (n=1) or were lost to follow-up (n=2). One participant was randomized by mistake but received no treatment.
735651|NCT01428024||
735652|NCT01427972||Participants (pts) were randomized to 1 of 4 arms, 3 LY2623091 (LY) and Eplerenone (Epl). Each participated in two 21-day treatment periods with washout period of at least 28 days. Pts who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Pts who received Epl in Period 1 were randomized to an LY arm in Period 2.
735653|NCT01427933||Participant Flow reports participants who discontinued from the study. Participants who died due to any cause and participants who were alive at conclusion of the study but off treatment were considered to have completed the study.
735654|NCT01427920|A total of 33 sites in 5 countries enrolled subjects.|
735655|NCT01427907||A total of 44 subjects signed the informed consent form (ICF), 5 subjects were not eligible, and 1 eligible subject withdrew the ICF prior to randomization.
735656|NCT01427881||
735657|NCT01427803||
735658|NCT01427751||
735659|NCT01427738||
735761|NCT01421277|216 of the 806 screened participants were eligible for the study and were invited to participate in the online survey.|
735762|NCT01421225||
735660|NCT01427608||269 participants were enrolled in the open-label phase. However, only 126 participants were eligible and consented to participate in the RCT phase. Reasons for not being eligible for the RCT phase included failure to achive remission criteria, discontinuation of treatment prior to the RCT, or decision by the participant not to consent to the RCT.
735661|NCT01427517|Subjects were primarily recruited from the investigators' clinics at the University of Minnesota, and from research volunteers signed up with the University's Center for Magnetic Resonance Research.|Groups were not assigned in this study. All subjects received the same intervention.
735662|NCT01427504|Recruitment occured at the University of Colorado Hospital beginning September 1, 2011 and ended on October 4, 2011.|There were 8 subjects that were excluded from trial before assignment to groups; 5 due to personal reasons, 2 due to elevated bilirubin, and 1 due to elevated serum creatinine.
735663|NCT01427309|The study participants were enrolled from 06 September through 09 October 2011 for Year 1; and 09 through 21 October 2012 for Year 2 at 126 sites in the United States and Canada.|A total of 31,989 participants were enrolled 31,983 were randomized and vaccinated in this study.
735664|NCT01427296||
735665|NCT01426958||
735666|NCT01426867|Subjects were recruited from 5 investigational centers in the United States.|Of the 103 enrolled, 2 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (101).
735667|NCT01426854|Participants were recruited from 8 study centers in China. Chinese men or women of at least 18 years of age who needed cataract extraction with implantation of a posterior chamber intraocular lens were enrolled and randomized in a ratio of 1:1 to receive either nepafenac or placebo.|This reporting group includes all enrolled participants.
735668|NCT01426828||
735669|NCT01426789|The study included a 12 week, randomized, double blind phase (part 1), a 40 week, open label phase (part 2), and a 3 month safety follow-up. Participants from the secukinumab arm, who completed part 1 and had an ACR50 or greater response at week 12, and participants from the placebo arm, who completed part 1, were eligible for the open label phase.|One hundred participants received study treatment in part 1. Ten participants discontinued during part 1. At the end of part 1, 76 participants were eligible to take secukinumab treatment in part 2.
735670|NCT01426763||
735671|NCT01426581|Participants were randomized into TTG or BI between September 2011 and February 2013. Of the 120 participants, 100 were enrolled at hospital #1 and 20 were enrolled from hospital #2.|
735672|NCT01426555||
735673|NCT01426516||
735674|NCT01426438|A5293 opened to accrual under protocol version 1.0 on November 8, 2011. The first participant was enrolled on January 10, 2012. Accrual to the study closed on April 24, 2013, with a total of 99 participants enrolled from 11 sites within the US.|
735675|NCT01426425|Thirty-seven (37) centers (8 in Canada, 29 in the US) confirmed participation in the study, with enrollments having occurred at 34 of those centers. First study enrollment occurred on 14-MAY-2012 and the last enrollment occurred on 25-FEB-2015.|
735676|NCT01426412||
735677|NCT01426386|A total of 7 sites randomised subjects to the trial: 1 in Belgium, 1 in Czech Republic, 1 in Denmark and 4 in Spain.|In total 334 subjects were screened. Of these, 69 were screening failures and 265 were randomised. All randomised subjects were exposed to investigational medicinal product (IMP).
735678|NCT01426373|The study was conducted at 18 investigational centers in the United States.|
735679|NCT01426360||
735680|NCT01426347||One hundred thirty-nine (139) participants were enrolled for visit 1, and blood was drawn to determine vitamin D levels. Eighty-three (83) were vitamin D deficient by criteria, vitamin D < 30 nanogram/milliliter (ng/ml), and entered the randomized controlled trial. The remaining 56 exited the study because they were vitamin D sufficient.
735681|NCT01426269||Subjects were treated with doxycycline or placebo for 52 weeks (Period 2) after a 12 week treatment regimen of doxycycline and metronidazole (Period 1). Subjects who completed period 1 with clear/near clear IGA, or achieved at least a 2 grade IGA improvement were eligible for period 2 of the study.
735682|NCT01426230||201 patients were enrolled, but only 197 patients received study treatment.
735683|NCT01426217|The study was conducted over 3-month period (Aug 1, 2011 to Nov 8, 2011) at Dartmouth-Hitchcock Medical Center, a tertiary care and level 1 trauma center in New Hampshire with 400 inpatient beds and 28 operating suites. The operating rooms enrolled during the study period were randomly selected on a daily basis from the available 28 operating rooms|
735684|NCT01426191|post market|Third-generation cephalosporin resistant
735685|NCT01426113|The study was discontinued prematurely after enrollment of 6 patients.|
735686|NCT01426009||One randomized subject did not receive any study medication.
735687|NCT01425879|Patients were enrolled between September 2012 and December 2013|
735688|NCT01425853||
735689|NCT01425814|The study was conducted in 9 sites in Germany, 8 of which randomized patients|Screening took place 14±2 days before randomization. After screening, eligible patients entered a run-in period to assess clinical stability. A total of 87 patients were screened, of whom 70 patients were assessed as eligible and randomized; 17 were not randomized due to screening failure (primarily non-fulfillment of inclusion/exclusion criteria)
735690|NCT01425801|The study was conducted in 10 sites in Germany and United Kingdom, 9 of which randomized patients|Screening took place 12-16 days before randomization. After screening, eligible patients entered a run-in period to assess clinical stability. A total of 115 patients were screened; 62 patients were assessed as eligible and randomized; 53 were not randomized due to screening failure (primarily non-fulfillment of inclusion/exclusion criteria)
735691|NCT01425749||
735692|NCT01425723||Participants who completed either of the Phase 3 studies (Study 998HB102 [NCT01027364], Study 9HB02PED [NCT01440946]) were expected to be eligible to enroll in this study.
735693|NCT01425632||
735694|NCT01425528|Participants were recruited from August 2011 through August 2013. Participants were patients who had been seen clinically for GTPCH deficiency and indicated previously that they would be interested in future research.|This is a pilot study and all participants are in the treatment group.
735763|NCT01421147||This study included a 24-week treatment period followed by a 28-week extension period.
735764|NCT01421134||
735765|NCT01420965||
735695|NCT01425463|This multicenter study started to enroll subjects in March 2011 in order to end up with 16 centers in China with enrolled subjects.|Participant Flow refers to the Randomized Set (RS). The RS includes all subjects who have a randomization number recorded on the Case Report Form (CRF).
735696|NCT01425359|Participants were enrolled at a total of 116 study sites in North America, Europe, and Asia. The first participant was screened on 05 October 2011. The last participant observation occurred on 25 October 2012.|1142 participants entered the qualifying period.
735697|NCT01425307|"Phase 3 First Patient In: 16-Sep-2011; Last Patient Last Visit 10-Feb-2015
~26 medical institutions in the United States of America and Canada"|159 were enrolled. 121 met eligibility criteria and randomized to treatment.
735698|NCT01425281|A total of 501 patients (335 participants in the Absorb arm and 166 subjects in the XIENCE arm) were randomized into the ABSORB II Randomized controlled trial (RCT) at 46 international outside the United States (OUS) sites study sites. First subject was randomized on 28 November 2011 and the last subject randomized on 04 June 2013.|Early termination by 5-year affected 120 patients due to subject withdrew consent (n=20), withdrawn by the site (n=1), lost to follow-up (n=9), death (n=20),early termination due to a lapse in the protocol renewal by the Polish Ethics Committee (n=37) and early terminations due to 'other' reasons (n=33).
735699|NCT01425268|Participants were recruited were current patients at the investigator's practice who were scheduled to undergo two-stage breast reconstruction between November 2011 - December 2014.|
735700|NCT01425229||
735701|NCT01425203|A total of 18 Russian sites recruited participants for this boceprevir (BOC) trial.|Of 238 randomized participants, 237 received at least 1 dose of peginterferon alpha-2b (PEG) + ribavirin (RBV) [PR] and comprised the Full Analysis Set (FAS). 4 discontinued (DC) treatment during the PR lead-in phase and did not receive BOC or Placebo (PBO). 27 from PBO Arm failed the futility time point and were rolled over into Crossover Phase.
735702|NCT01425190||This study originally intended to enroll 3 age-based pediatric cohorts. However the study was terminated after the completion of Cohort 1. No participants were enrolled in either Cohorts 2 or 3. Only data from Cohort 1 was collected.
735703|NCT01425008|Participants took part in the study at 16 investigative sites in the United States and United Kingdom from 13 September 2011 to 16 October 2018.|Participants with relapsed and refractory solid tumors and metastatic melanoma were enrolled in Dose Escalation Phase and Dose Expansion Phase respectively to receive TAK-580 (MLN2480), once every other day (Q2D) or once weekly (QW). Q2D Dose Expansion Phase, TAK-580 (BRAF+) was discontinued due to sponsor's decision of strategic deprioritization.
735704|NCT01424943||
735705|NCT01424930|The study was conducted from 29 September 2011 to 29 May 2013. Participants were recruited at 2 study centers in Canada.|
735706|NCT01424813||384 patients screened; 180 patients were excluded on the basis of inclusion criteria, 4 due to exclusion criteria, 21 patients withdrew consent, 1 patient was lost to follow-up before the baseline visit, 6 patients had other reasons, and 14 patients failed to meet randomization criteria at the end of the run-in period.
735707|NCT01424670||511 participants were randomized to receive investigational medicinal product (IMP) and an optimized background treatment regimen (OBR) for 6 months, followed by OBR treatment alone for 12-18 months. The trial also included a post-treatment follow-up period of 6-12 months. Participants who stopped taking IMP and/or OBR could remain in the study.
735708|NCT01424644|Subjects were enrolled in two countries (US and Italy).|All enrolled subjects were included in the trial.
735709|NCT01424566||Per the Statistical Analyses Plan, all randomized participants who received at least 1 dose of study drug were analyzed in the Intent to Treat (ITT) population as per randomized treatment group. Participants were included and analyzed according to the treatment group they were randomized to.
735710|NCT01424514|The study was planned on 40 participants, male or female between 18 and 65 years of age with non-allergic rhinitis (NAR), at a single center of Canada from 7th December 2010 to 18th April 2011.|
735711|NCT01424501||During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions, and medical history of subjects was collected. Prior to vaccination, subjects' pre-vaccination body temperature was evaluated.
735712|NCT01424397|A total of 70 male and female participants with a history of allergic rhinitis (AR) were enrolled in this study. Study period was 14 April 2011 to 07 July 2011.|There were 3 study treatment periods each lasting 8 days separated by a washout of 14-20 days. Participants were randomized to 12 different sequences.
735713|NCT01424306|63 volunteers who responded to newspaper advertisements and fliers posted in the Seattle area were screened for eligibility between December 2011 and December 2013.|Of those 63 volunteers screened, 38 did not meet inclusion criteria and 0 declined to participate. 25 subjects randomized
735714|NCT01424228||
735715|NCT01424215||
735716|NCT01424189|Participants were recruited from 21 investigative sites located in the United States.|Of the 677 participants enrolled, 103 were exited prior to randomization as screen failures. This reporting population includes all participants with successful IOL implantation in at least 1 eye (574).
735717|NCT01424072|Recruitment was conducted between January and September 2011 at University Hospital. Study participants were professionals from different sectors of the hospital after the invitation and 109 people answered the Stress Symptoms List. Obeying the exclusion criteria, 75 subjects were enrolled and randomized into three groups.|Of the 109 subjects, 4 were eliminated for having a low level of stress and three for not belonging to nursing staff.
735718|NCT01424033|5 subjects consented but did not participate in study due to departure of PI from institution.|5 subjects consented to participate due to the PI departed the institution. Numbers in patient flow were updated to reflect this.
735719|NCT01423916|A randomized, double-blind, placebo and positive-controlled, parallel-arm study to examine the effects of 2 dose levels of brexpiprazole on the QT/QTc (QT interval corrected for heart rate) interval. This study was run in 8 sites in the US.|Participants were screened from Days -28 to -6 and washed out from their current antipsychotic medication between Days -5 to -2 and resumed antipsychotic therapy by study physician on Day 13 or at early termination (ET). A safety Follow-up was done 30 (+2) days after last dose of study medication.
735720|NCT01423812||
735721|NCT01423773|Partipants were recruited from one US study center.|This reporting group includes all enrolled participants.
735849|NCT01414036||
735722|NCT01423760|First/last subject (informed consent): January 2012/July 2012. Subjects randomized at 9 sites in Canada and Sweden.|Subjects who participated in the tecemotide (L-BLP25) clinical trials (EMR 63325-005, EMR 63325-006, and EMR 63325-008 served as feeder studies) were considered in this follow-up study after the protocol specific inclusion and exclusion criteria to continue their maintenance treatment. A total of 27 subjects were enrolled in this follow-up study.
735723|NCT01423617||
735724|NCT01423604|The open-label, safety run-in (1 cohort) was designed to confirm the safety of the combination of ruxolitinib and capecitabine in subjects with advanced or metastatic adenocarcinoma of the pancreas. The double-blind portion was 2 treatment groups randomized 1:1: ruxolitinib plus capecitabine or matching placebo plus capecitabine.|
735725|NCT01423253||
735726|NCT01423162|Recruitment took place in August 2011|One subject was excluded prior to group assignment due to illness
735727|NCT01423084|Actual start date of recruiting was 30 August 2011. Subjects were recruited from 7 centres in Canada and 6 centres in Australia.|All subjects were enrolled in the trial.
735728|NCT01422915|Dates: February and March 2011.Location types: suburbs of Massachusetts (3 subjects) and in New Jersey (1).|All 4 subjects were enrolled in the study. Initially, baseline blood protoporphyrin concentrations and answers to sun sensitivity questionnaire were obtained.
735729|NCT01422889|Subject recruitment began on 19 September 2011 and was completed on 24 April 2012.|
735730|NCT01422876||Of the 1405 patients enrolled and randomized the data for 42 randomized patients were excluded from all analyses due to serious non-compliance. Therefore, 1363 patients were included in the analyses.
735731|NCT01422850|The subjects was recruited consecutively. The subjects were hospitalized on the day ALECSAT was administered and also one day after the first administration. The overall study period for each participating patient was 25 weeks. The subjects were followed closely during 12 weeks after last treatment by planned study visits.|
735732|NCT01422824||
735733|NCT01422720|"44 clinical centres in Europe and Asia.
~Studied period (years):
~Date of first enrolment: 19-APR-2010 Date of last subject completed: 08-OCT-2013"|In this trial all subjects received the same treatment.
735734|NCT01422538|Thirty subjects were assigned to three treatment groups. Subjects NOT willing to pay for Sculptra were assigned to Treatment Group A. Subjects willing to pay for Sculptra were randomly assigned to either Treatment Group B or Treatment Group C.|Thirty subjects were enrolled and thirty subjects were treated in the study. The first subject was treated on June 28, 2011; the last subject was treated on March 28, 2012. The last patient follow-up for the trial was September 24, 2012.
735735|NCT01422434|First Subject First Visit: 06-Aug-2011 Last Subject Last Visit: 28-May-2012|Prior to randomisation at Visit 1 (Day 0), a washout period of up to maximum 4 weeks was completed if the subject was/had been treated with anti-psoriatic treatments or other relevant medication, as defined by the exclusion criteria
735736|NCT01422408||
735737|NCT01422382|1st Subject Enrolled 05 May 2011, Last Subject Completed 12 July 2011 at PPD Inc. 7551 Metro Center Drive Suite 200 Austin, TX 78744|
735738|NCT01422369|1st Subject Enrolled 20 April 2011 Last Subject Completed 10 June 2011|
735739|NCT01422356|Two hundred males aged 16 to 20 years were recruited into the study. Men were seen at 0, 3, 6 and 12 months.|
735740|NCT01422304||
735741|NCT01422239|Recruitment of participants began in August of 2011 an ended in September 2012. Recruitment methods included radio advertisements, ClinicalTrials.gov, Craig's List postings, flyers, and referrals from research colleagues in the Department of Psychiatry|28 adults signed the consent form and 20 adults were randomized and began the study. The 8 participants who completed the consent procedures but were not randomized were either not eligible (drug use, n=3; psychiatric diagnoses, n=2; low smoking, n=1) or did not attend the first study appointment and did not respond to attempts to contact (n=2).
735742|NCT01422226||
735743|NCT01422213|Patients were selected from psychiatric settings, outpatient clinics, and inpatient hospitals; and recruited via ads (if allowed in the country) or referrals (from general practitioners). A Pre-Randomisation Form completed by the site for each patient was reviewed by the CRO Medical Expert to confirm patient eligibility prior to randomisation.|Patients were randomised equally (1:1:1) at the Baseline Visit to placebo, vortioxetine 10 mg/day, or vortioxetine 20 mg/day for 8 weeks of double-blind treatment (8-week Core Treatment Period).
735744|NCT01422200||
735745|NCT01422187||
735746|NCT01422161|Sample size is estimated based on a treatment difference of 20% between the two groups|
735747|NCT01422135||
735748|NCT01422070|All admissions of patients aged ≥ 16 years to a study during 28-day period (from 7 Nov to 4 Dec 2011, or from 16 Jan to 12 Feb 2012), excludind admissions only for organ donation, and with any limitation of care stated before unit admission. Maximum number of admissions per unit was 100.|Prospective observational study, without group assignment. Study units gave information about organization. 32 admissions to units with level of care lower than intensive care unit (ICU), 337 readmissions, 83 admissions out of the dates of enrollment slots, and 147 admissions with unknown vital status at hospital discharge were excluded.
735749|NCT01421719|Recruitment period extended between February 1, 2009 and September 2010. Stanford University Clinics represented location for enrollment and clinical trial.|Patients underwent screening in the clinic and were excluded per protocol prior to enrollment. Open label study.
735750|NCT01421667|Aug 2011 - Jun 2015|Four additional patients enrolled, but withdrew prior to receiving treatment.
735751|NCT01421654|The study was conducted at one (1) clinical site in the US. The first subject was consented 06Sept2011 (Subject 01) and the last subject consented on 23Nov2011 (Subject 23).|
735752|NCT01421641|We conducted a randomized, single-blinded clinical trial from August 2011 to May 2012 at the Center for Women's Health at Oregon Health & Science University (OHSU; Portland, Oregon).We recruited women aged 18 years and older who were scheduled to undergo IUD placement or endometrial biopsy.|Exclusion criteria included 1) allergy to lidocaine or other local anesthetics; 2) pregnancy; 3) patients pre-medicated with misoprostol; and 4) patients with a chronic pain condition for which they were taking daily pain medications of any kind. The subjects were recruited, consented, and enrolled immediately prior to the procedure.
735753|NCT01421589||
735754|NCT01421511||
735755|NCT01421498||The study was conducted in a Controlled Adverse Environment (CAE).
735756|NCT01421472||
735766|NCT01420926|165 participants were enrolled from 24 sites from November 2011 to March 2013|Two (2) participants never received any protocol treatment; per study design these patients were excluded from all analyses.
735767|NCT01420848|The recruitment of students was conducted between January and July 2011 at the Nursing School of Portuguese Beneficence Hospital. Eighty five people were invited and seventy one subjects were enrolled and randomized into 3 groups.|No sample size calculation was done for this study because the number of the population was small and it was decided to invite all students to attend nursing school test.
735768|NCT01420653|"455 Subjects have been consented and screened, out of which 47 subjects were screening failures and did not receive the first dose of study medication.
~Among 408 subjects, 273 subjects enrolled from New Zealand sites and 135 subjects enrolled from USA site from May 2013 to Jan 2015."|
735769|NCT01420627||
735770|NCT01420549|Participants were recruited at 7 research centers between March 2013 and July 2014. The first participant was enrolled on March 21, 2013 and the last participant was enrolled in July, 2014.|Of 637 recruited participants, 254 met eligibility criteria and were recruited in the run-in phase.The participants received Simvastatin 20 mg tablet orally once daily for 5 weeks in this period and 241 completed the run-in phase. Of the 241 participants, 129 were eligible for the treatment phase and randomized.
735771|NCT01420289||
735772|NCT01420146||
735773|NCT01420081|An open-label, Phase 2, four-arm, non-comparative study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of PF-04691502 (an oral PI3K/mTOR inhibitor) and PF-05212384 (an Intravenous [IV] Phosphoinositide 3-Kinase [PI3K]/Mammalian Target of Rapamycin [mTOR] inhibitor).|This study was conducted in parallel-arms in adult participants with recurrent endometrial cancer. Randomized arms included PF-05212384 (154mg dosage) and PF-04691502 (8mg which was lowered to 6mg) for both PI3K Basal or Activated. Lead-in Cohorts included PF-05212384 (89mg or 154mg) and PF-04691502 (4mg).
735774|NCT01420068||
735775|NCT01420016|All adult primary care providers (physicians, PAs, NPs) employed full-time as of August 2012 were eligible for the study. Providers received a letter from the study PI inviting them to participate with a link to the consent form. Patient consent was waived by HPI IRB since there was no direct contact between the patient and the study team.|13381 subjects were assessed for eligibility for the Primary analysis; a partially overlapping population of 11551 subjects were passively monitored for safety outcomes. Consent was waived for all participants. The total number of participants is unknown; therefore, the enrollment only counts participants who were included in the final analysis.
735776|NCT01419977||Of the 34 subjects were consented, 29 are received drug and had the day 1 blood draw. 2 subjects withdrew prior to receiving study drug. In addition, 2 subjects were discharged and 1 subject received a transfusion prior to the blood draw on day 1.
735777|NCT01419795||
735778|NCT01419769||
735779|NCT01419717|This study was conducted at 65 centers in Europe, Latin America, Japan, and South Africa. Participants were enrolled from 22 November 2011 to 27 October 2014.|
735780|NCT01419639|10 people enrolled; a total of 9 completed study|
735781|NCT01419626||
735782|NCT01419314|The participants were randomized to use a night application of bilateral lower extremity splints (23 participants) or using the soft liners of the splints only (23 participants). One participant was excluded from the liner group as he failed to disclose a recent diabetes diagnosis.|One of the participants in the liner group was excluded from the study at the beginning as he developed type-II diabetes. The total number of participants in the liner group was thus 22 at baseline.
735783|NCT01419275|Enrollment was closed prior to any enrollment in the acute stroke, healthy participant, and diagnosis unspecified groups, so results are presented for the Moyamoya group only.|
735784|NCT01419249||
735785|NCT01419236||
735786|NCT01419197||A total of 602 patients were randomized to the study (404 to receive Trastuzumab Emtansine and 198 to receive Treatment of Physician's Choice).
735787|NCT01419184||One participant enrolled in the study but was lost to follow up prior to being randomized to either treatment arm (daptomycin or vancomycin). This participant did not receive study drug and was not included in further analysis. No further details are available for this participant.
735788|NCT01419171||
735789|NCT01419080||
735790|NCT01419028|Patients were enrolled between Sept 2012 and Apr 2013. 65 patients were screened and 48 were enrolled at 12 sites in 7 countries. Patients were recruited from investigational sites established at academic research and medical centers known to diagnose and/or treat patients with HPP. Both living and deceased patients were considered to partricipate.|
735791|NCT01419015||
735792|NCT01418937||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
735793|NCT01418703||
735794|NCT01418482||
735795|NCT01418378|191 subjects were recruited at sites in the UK, India and Singapore. Enrollment took place between 3 August 2011 and 21 January 2014|After written informed consent was obtained from subjects, eligibility was confirmed and subjects were allocated a subject identification number
735796|NCT01418365||
735797|NCT01418209||
735798|NCT01418001||
735799|NCT01417936|First subject (informed consent): 15 July 2011. Last subject completed: 08 October 2012; Clinical data cut-off: 08 October 2012. Subjects randomized at 10 centers in Belgium, France and Germany.|A total of 28 subjects were screened for eligibility, 2 were excluded (mainly non-fulfillment of inclusion or exclusion criteria) and 26 subjects were randomized.
735800|NCT01417741|randomization of three patients unrecorded, so 161 properly randomized patients were entered in study|
735801|NCT01417481|Patients attending the Hospital Infantil de México and the Instituto Mexicano del Seguro Social (both in Mexico city) were recruited from March 7, 2012 to October 31, 2012. The two arms of the study were: 1) Glycine, then placebo, and 2) Placebo, then glycine.|
735850|NCT01414010||
735851|NCT01413958|"29 centers in the United States;
~Study Period: August 2011 to October 2011"|
735852|NCT01413750||
735897|NCT01411085||Two participants were enrolled in a risperidone + placebo arm, but in 6/2013 the design of the study was changed to include only the risperidone + desipramine arm.
735802|NCT01417455|Patients with RA and AS were recruited from the Rheumatology and Bone Metabolic Disease Department, Hospital de Santa Maria, Lisbon Academic Medical Centre, Portugal from May 2011 to May 2014. Healthy donors were recruited among the Hospital and research centre personnel.|Aparent discrepancy of Enrollment number (101) and Participant Flow module (147) derive from patient follow-up. Patients enrolled were 101. 16 RA were followed up on the RA with DMARDs cohort. 17 RA baseline for TNF-blockers were followed up in the RA with TNF blockers. 13 AS baseline for TNF-blockers were followed up in the AS with TNF blockers.
735803|NCT01417377||
735804|NCT01417234||
735805|NCT01417195||A total of 122 subjects (60 Menopur/Bravelle, 62 Menopur) entered pituitary down-regulation and were randomized in the study.
735806|NCT01417156||
735807|NCT01417104|Participants recruited from The Ohio State Medical Center and Columbus surrounding area between April 2009 to December 2011.|187 participants screened; 116 did not meet inclusion criteria or meet exclusion criteria; 71 randomized.
735808|NCT01417078||
735809|NCT01417026||The number of enrolled participants in the study was 36, but only 29 of those subjects were randomized. The 7 subjects who were not randomized did not meet study diagnostic or cognitive inclusion criteria.
735810|NCT01417000|This study enrolled subjects with malignant metastatic adenocarcinoma of the pancreas who had received or refused at least one prior chemotherapy regimen. Study was conducted in the United States at 10 medical centers; however, 1 center did not enroll any subjects. The last subject completed the study in February 2017.|Participants screened over a 28-day period.
735811|NCT01416987||
735812|NCT01416805||
735813|NCT01416636||
735814|NCT01416610||
735815|NCT01416584|Participants were recruited through agencies that served the target population, street outreach, and a respondent-driven sampling referral system in which study participants were paid for successfully referring others to the study. Interested individuals completed a brief screening interview that gauged study eligibility.|Eligible participants were invited to participate in a 4-week induction. During induction, participants were invited to attend the therapeutic workplace. Participants who attended the workplace for at least five minutes on two out of five workdays in the last week of induction were randomly assigned to one of three conditions.
735816|NCT01416571|This study was conducted in two phases: the Primary Vaccination Phase (up to Day 84) and the Immunogenicity and Safety follow-up Phase (up to Day 385).|
735817|NCT01416389||Participants completed the study if they had at least 1 dose of study drug in Cycle 2 (or later) and had at least 1 post-baseline radiological tumor assessment or if the participant had a progression of disease or death. Non-completers were those that were lost to follow-up or who withdrew their consent to trial participation.
735818|NCT01416272||
735819|NCT01416194|This is a retrospective, observational, non-interventional study. Data was collected from proprietary longitudinal patient databases (LPD).|The index date for each participant was the date of first recorded prescription for bazedoxifene, raloxifene or bisphosphonate. Follow-up period was from index date to first incident of primary event or date of last contact, whichever occurred first. Follow-up was maximum up to approximately of 92.1 months.
735820|NCT01416181||
735821|NCT01416155|Subjects who participated in and completed all protocol-related evaluations through Week 24 in Study 101MS203 (NCT01440101) were eligible for this study.|
735822|NCT01416142|First participant was enrolled on 7/6/2011 and last participant exited the study 8/21/2011. Participants were enrolled from 4 ophthalmology sites in the US. Study visit 1 was the screening visit, visit 2 took place in a movie theatre and visit 3 was 1 week follow-up visit.|63 eligible participants were enrolled in the crossover design study, 62 participants completed the study.
735823|NCT01416129||
735824|NCT01416025||
735825|NCT01415986||
735826|NCT01415960||
735827|NCT01415934||
735828|NCT01415921|Admissions logs and other existing electronic hospital information systems|
735829|NCT01415908||
735830|NCT01415583||
735831|NCT01415531|Patient recruitment occurred over a 4 month period from August 2011 to December 2011 at 76 study sites in the United States.|
735832|NCT01415518||
735833|NCT01415453|Recruitment occurred at the Department of Ophthalmology, Columbia University Medical Center from July 2011 to June 2012.|No significant events followed enrollment prior to group assignment. There was only one group in this study: people with retinitis pigmentosa who were legally blind.
735834|NCT01415440|Recruitment started in 2011 and ended in 2018. Participants were primarily recruited from the community through advertisements in local newspapers and flyers posted in local establishments. Participants were also recruited from other research studies and doctor's offices.|18 ADHD participants withdrew or were excluded from the study prior to randomization and thus are not included. Participants who withdrew were no longer interested in treatment or were lost to follow-up. Participants were excluded due to subthreshold ADHD symptoms, comorbid psychiatric conditions, & MRI contraindications.
735835|NCT01415427||
735836|NCT01415401|Participants were recruited from 8 study centers located in Canada.|Of the 57 enrolled, 3 participants were exited as screen failures. This reporting group includes all participants who received study medication (54).
735837|NCT01415349||
735838|NCT01415232|From August 2010 to June 2011, a total of 160 parturients from Magee-Womens Hospital of UPMC.|
735839|NCT01414855||
735840|NCT01414634||
735841|NCT01414413||
735842|NCT01414257||
735843|NCT01414244||
735844|NCT01414205||
735845|NCT01414192|Data was provided by French physicians for participants who were being administered Ezetrol® monotherapy, or Ezetrol® coadministered with a statin, or Inegy® (a fixed-dose combination of ezetimibe and simvastatin.|All participants who met inclusion criteria and contributed to at least one type of follow-up data in the form of an interview or physician questionnaire were included in the study.
735846|NCT01414166|This study took place at 37 centers in 2 countries (29 sites in India and 8 sites in Philippines).|
735847|NCT01414153||
735848|NCT01414114|This study was conducted at 5 centers in the United States from 05 December 2011 (first participant enrolled) to 21 May 2012 (last participant completed follow-up).|
735853|NCT01413542||44 participants were enrolled in this study (23 in Group 1 and 21 in Group 2) and completed screening procedures. Twelve of 23 participants met inclusion and exclusion criteria and completed all study-related procedures in Group 1. Seventeen of 21 participants met inclusion/exclusion criteria and completed all study-related procedures in Group 2.
735854|NCT01413516||
735855|NCT01413503||
735856|NCT01413360||
735857|NCT01413204||
735858|NCT01413191|Recruitment Period: August 02, 2011 to August 23, 2012. Recruitment was done at The University of Texas MD Anderson Cancer Center (MD Anderson) and The Thomas Jefferson University.|
735859|NCT01413178|All participants were registered in MD Anderson Cancer.|
735860|NCT01413087||
735861|NCT01412983|This study was conducted at 5 clinical sites in the US. First participant was enrolled 08/08/2011 and last participant exited on 09/01/2011.|100 participants (200 eyes) were enrolled in this 2 week crossover study. Participants were divided into 2 groups wearing one study lens for 1 week and then crossing over to the other study lens for 1 week. 96 participants completed the study, 1 participant was ineligible at baseline while 3 participants were discontinued during the study.
735862|NCT01412957|"A total of 377 participants were randomized at 66 centers in Europe, Asia, North and South America from 8 November 2011 until 30 July 2013.
~Results are reported as of the primary analysis data cut-off date of 10 June 2014."|Participants were stratified according to geographic region (Europe vs Asia vs rest of the world) and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs 2) and randomized (1:1 ratio) to 1 of 2 treatment groups.
735863|NCT01412944|This study consisted of 3 study periods: I.V. (I.V. infusion and subcutaneous (s.c.) regimens given in a double-blind fashion), Maintenance and follow-up. Participants, who were identified as partial responders at week 12 of study CAIN457A2304 (NCT01406938), were eligible to roll into CAIN457A2307.|Participants of the CAIN457A2304 150 mg or AIN457 300 mg treatment groups, who were partial responders at week 12 of CAIN457A2304, were randomized in a 1:1 ratio to the AIN457 300 mg s.c. or AIN457 10 mg/kg I.V. treatment groups of CAIN457A2307.
735864|NCT01412918||
735865|NCT01412879||
735866|NCT01412866||
735867|NCT01412801|Subjects were enrolled at Malawi and South Africa|All the enrolled subjects are included in the trial. Also,only the mothers who received the glycoconjugates were considered enrolled.
735868|NCT01412710|Subjects were recruited from two clinics in Miami-Dade County, Florida (Borinquen Health Care Center and Clinical Care Medical Center) from July 2011 to March 2013 using flyers explaining the purpose of the study.|15 participants did not qualified due to normal levels of serum vitamin D, 25-hydroxy vitamin D [25(OH)D].
735869|NCT01412554|"During 1991-96 men from the military enlistments were examined at Center of Cardiovascular and Renal Research, Division of Medicine, Oslo University Hospital, Ullevål, using hyperinsulinaemic isoglycaemic glucose clamp technique to assess insulin sensitivity.
~They were re-invited to participate in the presented study during 2012-13."|103 consented to participation.
735870|NCT01412541||
735871|NCT01412424||
735872|NCT01412372||
735873|NCT01412333||A total of 1045 participants were screened for entry into the study. Of these, 210 participants failed screening; the main reasons were failure to meet the inclusion/exclusion criteria or unacceptable laboratory values. A total of 835 participants were enrolled in the study.
735874|NCT01412281|Recruitment period: 06 October 2011 to 10 November 2011; outpatient study|
735875|NCT01412229|Subjects were recruited from 10/12/2011 through 4/24/2015.|Sixty-seven subjects were consented to this trial. Of these, 29 were not eligible. 38 subjects were treated.
735876|NCT01412164||
735877|NCT01412151||
735878|NCT01412086||
735879|NCT01412060||A total of 765 participants were enrolled and received cariprazine in Run-in Phase; 751 of these, had at least 1 postbaseline Positive and Negative Syndrome Scale (PANSS) evaluation and 364 entered Stabilization Phase. Only 200 participants who completed Open-label phase, received either placebo (n=99) or cariprazine (n=101) in Double-Blind Phase.
735880|NCT01412021||
735881|NCT01411995||
735882|NCT01411917||
735883|NCT01411891||
735884|NCT01411852|Patients were enrolled and randomized in the out-of-hospital setting. Nineteen Emergency Medical Service (EMS) systems and 10 hospital in 6 regions of the Resuscitation Outcomes Consortium (ROC) participated.|
735885|NCT01411839|Data were collected in a two-stage process from 10/21/2009 - 8/31/2011 at a publicly-funded community health clinic in El Paso, TX, on the U.S.-Mexico border.|Eligible participants were randomly assigned to the intervention or treatment as usual (TAU) control condition, both enhanced with the notification letter to provider. An external statistician had used a computerized random number generator to select random permuted blocks of four.
735886|NCT01411774||
735887|NCT01411696||
735888|NCT01411592||
735889|NCT01411527|"Cross-sectional study: All pupils at 10 different schools in the Copenhagen area were invited to participate.
~Longitudinal study: All pupils from 2 of the 10 schools were invited to participate in the follow up study. This includes pupils that have been recruited to the cross-sectional part. (see footnote)"|No participants were excluded
735890|NCT01411501|The participants were recruited through the inpatients and outpatients settings in the 8 hospitals.We also recruited the participants through television and newspapers advertisements.|Nine enrolled participants refused to join in the trial after signing the informed consent. So they were excluded from the trial.
735891|NCT01411488|"An interim analysis was planned one 70+ patients completed data collection to determine futility vs continued recruitment, enrollment and data collection.
~The analysis presented represents the interim analysis as it was determines that we should stop further recruitment and enrollment based on study findings."|An interim analysis was completed; see recruitment details
735892|NCT01411267||
735893|NCT01411241|Study participants were enrolled from 18 July 2011 to 31 July 2012 at 3 clinical sites in Mexico. The study planned for 732 participants; however, recruitment was stopped when 720 participants were enrolled due to the difficulty in enrolling participants.|A total of 720 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled, out of which 309 participants were randomized to Group 1 and 315 in Group 2, and 96 participants were not randomized to Group 1 or 2.
735901|NCT01410604|Subjects were enrolled between January 2007 and December 2009 in the Pediatric Obesity Clinics (POC) from third level Mexican Hospitals: the HMFG, located in the Federal District (country's capital), and the HRAEB, located in the city of Leon in the state of Guanajauto.|
735902|NCT01410565||
735903|NCT01410552||
735904|NCT01410474|Subjects were enrolled at three study centres in Taiwan.|All enrolled subjects were included in the trial.
735905|NCT01410448|This study included a 3 month treatment period followed by an observational follow-up period. Participants were treated as per local practice during follow-up and a follow-up evaluation was performed at 12 months.|Participants were randomized in a 1:1 ratio to one of the 2 treatment groups.
735906|NCT01410409||
735907|NCT01410357||
735908|NCT01410344||
735909|NCT01410240|Patients were enrolled at 12 clinical sites in the United States, beginning October 2011|137 participants were enrolled and screened. 5 were screen failures. 14 withdrew prior to surgery (1 physician decision, 4 study terminated, 8 withdrawn by participant, 1 sponsor educator not available). 12 were run-in participants. Therefore, 106 of the 137 enrolled were randomized.
735910|NCT01410227|Participants were enrolled (signed informed consent) from 30 sites in 15 countries.|49 participants provided informed consent and were screened for the study, of which 37 were exposed to study product. Reasons for discontinuation were 6 screen failures, consent withdrawn by 3 participants, 1 physician decision, 1 participant received high doses of rFVIII for oral procedure and arm for which 1 participant was eligible was closed.
735911|NCT01410110|Recruitment was by referral from clinicians at VA Substance Abuse program including a 21 day substance abuse day program and a 30 day residential program. Recruitment began in January 2011 and was completed in March 2014.|Following informed consent, participants completed baseline assessments and their VA medical record was reviewed to determine whether they met inclusion/exclusion criteria.
735912|NCT01410097|Participants who enrolled in the main Look AHEAD study were eligible to participate in this ancillary study. Starting at year 8 clinic visits of the main study at 4 sites (Pennington, Denver, Pittsburgh, and Memphis) participants were asked if they would participate in this study (9/09-06/12). Those who agreed & consented were then enrolled.|
735913|NCT01410084||
735914|NCT01410058|HIV-infected male and female adults reporting for routine HIV clinic visits at a referral hospital in Zimbabwe were identified through an interviewer-administered questionnaire.|The study had a minimum 3-week herbal medication wash out period prior to the first dosing to reduce the possibility of carryover from any type of previously used moringa or other herbal medication, so the participants would have the same baseline.
735915|NCT01409993||
735916|NCT01409928||
735917|NCT01409837|As per protocol the recruitment of patients took place from March 1998 to September 2001 while the actual investigation took place from January 2002 to December 2006.|During the recruitment period a total of 131 male patients being treated for low sperm count of unknown cause volunteered to participate. They were screened based on the criteria for eligibility as per protocol. Only 33 (25.2%) satisfied the inclusion criteria and were randomized such that 16 were in group A while 17 were in group B.
735918|NCT01409811||
735919|NCT01409707|Recruitment occurred at a residential substance abuse treatment facility between July 2008 and June 2011.|222 assessed; 96 ineligible. 53 did not have current PTSD, 6 did not have current alcohol dependence (AD), and 2 did not have either current PTSD or AD. 35 participants were ineligible for other reasons (e.g., current mania, current psychosis, etc.).
735920|NCT01409564|46 Subjects were enrolled in the single center of Seoul National University Boramae Hospital. The diagnosis of probable AD was made according to the criteria of NINCDS-ADRDA (MMSE score 10 ~ 26). Enrollment has started in July 2010 to end in March 2012.|
735921|NCT01409434||
735922|NCT01409382|Recruitment has started in March 2011 at a High-Risk Maternal and Fetal Unit of a tertiary hospital. Enrollment started in May 2011.|
735923|NCT01409291||
735924|NCT01409239|Patients were recruited from medical wards of the Ohio State University Wexner Medical Center from 9/1/11 to 5/31/12|Basal insulin was held prior to initiation of IV insulin and all non-insulin diabetes medications were held for the study. 42 patients signed consent. However, 9 subjects were removed due to protocol violation (new arrhythmia 2], new altered mental status [1], initiation of IV insulin [2], early hospital discharge [2], or sensor failure [2].
735925|NCT01409213||Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
735926|NCT01409096||
735927|NCT01409031|This trial was terminated early due to lack of recruitment.|
735928|NCT01408992|From July 2011 through September 2011, 643 Eligible persons agreed to participate. 85 persons withdrew later and 558 persons complete all study procedures.|A total of 551 subjects were required to obtain an 80% sensitivity rate for the original test, at a 95% confidence level, with 80% power, and a 7% margin of error. Considering 22.7% as the estimated prevalence of hearing loss [Prasansuk, 2000] and a 10% drop out rate, the total number of subjects needed was 606.
735929|NCT01408914|Recruitment was done through routine passive case detection in operation at ambulatory facilities in the Peruvian public health system (DISA IV-Lima Este and DISA V- Lima Ciudad).|180 participants were randomized in a 1:1:1 allocation to the 10, 15, and 20 mg/kg treatment arms.
735930|NCT01408901||
735931|NCT01408888||
735932|NCT01408862|Platelets from 20 healthy human subjects who were not taken any medication in the previous 10 days were studied during 18 month in our institution.|
735933|NCT01408732||Each group will get the same therapy in a different order Total number of subjects 18 with 2 incompletes. First period is 6 weeks with a 2 week washout period and 2 period is 6 weeks
735934|NCT01408719|Participants were recruited at the Richardson Centre for Functionals Foods and Nutraceuticals, University of Manitoba, Winnipeg during July 2010 to May 2011|Over 200 subjects were screened; 45 subjects were enrolled in the study and randomly assigned to the experimental diets (treatment groups).
735935|NCT01408706||
735936|NCT01408641||Three participants were withdrawn prior to assignment to a treatment group. Two did not return for study visits after signing consent and one did not meet eligibility criteria.
735937|NCT01408628||
757777|NCT00201773|Enrollment of postmenopausal women between January 2003 and July 2007|
735938|NCT01408576|The study started to enroll patients in July 2011 and concluded in February 2016.|Participant Flow refers to the Enrolled Set, that consisted of all subjects who gave informed consent.
735939|NCT01408563||
735940|NCT01408537|The enrollment took place in 2 sites (Department of Tropical Pediatrics, Faculty of Tropical Medicine and Nopparat Rajathanee Hospital) from 3rd May 2010 to 10th August 2010. One hundred and fifty two subjects who illegible for the inclusion and exclusion criteria were enrolled in the study.|There was no subject who did not get the study vaccine after informed consent was signed.
735941|NCT01408485||
735942|NCT01408329|Recruited from Palo Alto and surrounding areas by flyer and advertisement|Medical Screening Group Matching by 3rd party
735943|NCT01408303|The enrollment period started August 2011 and the last subject visit was May 2012. All subjects were qualified at the clinical site and eligibility was determined by each PI (96 sites)|Subjects underwent 6-week washout and diet stabilization period, discontinued use of any non-statin lipid therapies, continued their current statin regimen, and followed the NCEP TLC diet. Men and women considered to be at high risk for atherosclerotic CVD and who had high serum TG (≥200 mg/dL and <500 mg/dL) were eligible for randomization.
735944|NCT01408277||
735945|NCT01408147|12 WIC Clinics Recruited; 371 participants total across all clinics|
735946|NCT01408043||
735947|NCT01408030|Patients were recruited from the HHT clinics at 6 sites if they met all of the following criteria: age >=18; diagnosis of definite or possible HHT; epistaxis lasting at least 1 minute, occurring at least once weekly, and clinically stable during the preceding 8weeks; and had an Epistaxis Severity Score (ESS) of at least 3.0.|123 patients provided consent but 1 withdrew consent and 1 was excluded due to brain arteriovenous malformation. Therefore 121 patients were randomized and included in participant flow. 1 patient in the estriol group was subsequently removed after it was discovered that she was taking estrogen outside the protocol (protocol violation).
735948|NCT01407952||
735949|NCT01407926||
735950|NCT01407575||
735951|NCT01407523|"This study started to enroll subjects in July 2011 in order to end up with 4 centers in Japan.
~16 subjects were treated and completed the study. All 16 subjects are included in the Safety Set."|The Safety Set (SS) consisted of all subjects who started Levetiracetam intravenous (LEV IV) infusion after they had signed and dated the Informed Consent form. Participant Flow and Baseline Characteristics refer to the Safety Set (SS).
735952|NCT01407367||
735953|NCT01407354|Clinicaltrial.gov, facility IRB approved SCI database, medical community all helped recruit for this study|Randomized Controlled Trial (which arm to initiate study) cross over design with no wash out period between arms. Adjusted statistically for change in each arm and arm participation order.
735954|NCT01407276|One healthy matched control participant withdrew consent for study participation on Day 15; this participant was replaced. Thus, a total of 49 participants were in the study.|
735955|NCT01407094||Final enrollment Stage 1: 296 (146 SERT, 150 PBO). Individuals who responded to their Stage 1 treatment remained on that treatment in Stage 2. Individuals who did not respond to their Stage 1 treatment were switched to a different treatment in Stage 2.
735956|NCT01407068||
735957|NCT01406990||
735958|NCT01406938|966 patients randomized to two groups, induction secukinumab 150 mg or secukinumab 300 mg. Most randomized patients, 928/966 completed the 12-week induction period. 928 completed the induction period, a total of 843 were re-randomized to the maintenance period to either fixed interval dosing or start of relapse dosing at their respective dose level|
735959|NCT01406873||
735960|NCT01406860||
735961|NCT01406795|The study recruited a single patient in 2012 at the Stanford Medical Center. The study ended in 2013.|
735962|NCT01406717||
735963|NCT01406652||See below
735964|NCT01406574||
735965|NCT01406444||148 subjects were consented and screened, 90 subjects were randomized, and 82 subjects completed the baseline visit. Of the 90 who were randomized, 8 subjects did not attend their scheduled baseline visits and did not receive study medication.
735966|NCT01406223||Of the 282 participants who were consented and screened, 191 were screen fails, 2 withdrew voluntarily before being assigned to a study arm, and 13 were lost to contact between screening and the first study visit. Therefore, only 76 participants were randomized and started the study.
735967|NCT01406015||
735968|NCT01405950||
735969|NCT01405937|Japanese patients 20-70 years old (inclusive) with chronic, compensated, genotype 1 Hepatitis C (HCV) infection and HCV ribonucleic acid (RNA) levels ≥5.0 log IU/mL in peripheral blood at screening, who had failed to respond to prior treatment, were recruited from 22 sites in Japan.|51 participants were randomized to receive 12 or 24 weeks of vaniprevir in combination with 24 weeks of peg-IFN α-2b (peg-IFN) and ribavirin (RBV).
735970|NCT01405924||
735971|NCT01405911||
735972|NCT01405898||
735973|NCT01405820||Four of the 6 arms in the Randomized Treatment Period (the 'every 12 weeks' arms) were closed prematurely. Participants who completed randomized treatment, met rescue criteria, or were impacted by arm closure (and met rescue criteria) were eligible to enroll in the open-label treatment period.
735974|NCT01405794||
735975|NCT01405768||
735976|NCT01405742||Following enrollment, subjects initiated study drug according to the randomization to Arm A (once-weekly FVIII) or Arm B (thrice-weekly FVIII) for a 26 week period followed by a 72 hour washout period prior to crossover to the other arm for the second 26 week period.
735977|NCT01405560|Japanese patients 20-70 years old (inclusive) with chronic, compensated, genotype 1 Hepatitis C (HCV) infection and HCV ribonucleic acid (RNA) levels ≥5.0 log IU/mL peripheral blood at screening, who had failed to respond to prior interferon treatment, were recruited from 10 sites in Japan.|42 participants were randomized to receive 24 weeks of vaniprevir in combination with 24 weeks of peg-IFN α-2b (peg-IFN) and ribavirin (RBV).
735978|NCT01405508|"This study started to recruit patients in August 2011 and concluded in July 2012.
~105 subjects were randomized to 4 different treatment groups."|Participant Flow refers to the Randomized Set (RS).
735979|NCT01405469|Patients with symptomatic achalasia|16 patients were included as per protocol, no patient was lost during follow-up over a 2 year period
735980|NCT01405456||
735982|NCT01405196||Due to safety reason, dosing in 200 mg reporting arm was prematurely terminated and the participants were discontinued from it. Therefore, the statistical analysis plan was amended after it and 200 mg reporting arm was not included in efficacy data analysis.
735983|NCT01405053|Participants took part in the study at 19 investigative sites in the United States, Canada, France, Greece, Italy, and Poland from 16 June 2011 to 02 November 2015.|A total of 43 participants were screened, out of which 37 participants were randomized and treated in the study.
735984|NCT01405027||
735985|NCT01404988||
735986|NCT01404936|Recruitment Period: July 25, 1996 through March 3, 2000. All participants were recruited at UT MD Anderson Cancer Center.|Of the 35 participants registered, five (5) were excluded from the trial.
735987|NCT01404923||
735988|NCT01404832|Consecutive patients referred to a general GI clinic at our VA hospital for the evaluation of PPI-resistant heartburn were invited to participate.|102 patients agreed to participate. For 10 patients the symptom described was not consistent with heartburn and another 27 described heartburn that was not refractory to therapy. 65 patient had PPI-resistant heartburn; 33 were taking PPI incorrectly; 11 taking insufficient dose of omeprazole.
735989|NCT01404650|This multi-center trial evaluated AUY922 monotherapy as treatment for patients with gastrointestinal stromal tumor (GIST) refractory to, or intolerant of, imatinib and sunitinib. Between Dec 2011 and Jan 2015, 25 patients enrolled in the trial. Thirty-four patients (34) were planned to be enrolled but enrollment stopped early due to slow accrual.|
735990|NCT01404611||
735991|NCT01404572||A total of 12 participants were enrolled in this study, and all 12 received study drug within each treatment sequence.
735992|NCT01404559||
735993|NCT01404429||
735994|NCT01404325|232 patients who were de novo lung transplant recipients were planned for enrolling into the study. A total of 130 patients were actually randomized with 67 patients randomized to the quadruple low-level treatment arm and 63 patients randomized to the center-specific triple treatment arm.|
735995|NCT01404312|Forty-five Clinical Research sites across 10 countries participated in the study. The first participant was randomized on May 23, 2012. Accrual closed on November 12, 2014 with 3,000 participants enrolled in the study.|Randomization was 1:1, and stratified by CD4 count (< 100, 100-250, and > 250 cells/mm^3), and antiretroviral therapy status (receiving antiretroviral therapy or not receiving antiretroviral therapy at enrollment).
735996|NCT01404260||
735997|NCT01404234|Subjects were enrolled at a total of 25 study sites in the United States and Europe. The first participant was screened on 29 December 2011. The last participant observation was on 03 April 2013.|74 participants were screened; 61 participants were enrolled and treated, and comprise the Safety Analysis Set and the Full Analysis Set.
735998|NCT01404208||206 subjects were initially enrolled at MGH and USF. Of those, 32 were considered screen fails and 32 were not randomized either because they did not meet inclusion or exclusion criteria at randomization or because they withdrew consent or dropped out. Thus, 142 participants were randomized.
735999|NCT01404078|Hospitals in India identified potential consenting eligible subjects with a history of stable cardiovascular disease or high risk for cardiovascular disease and subjected them to an active run in with single dose and then double dose of polycap. Only patients successfully completing the active run in (>80% compliant) were randomized into the trial|725 Started on Phase 1 run in low dose polycap 645 started on phase 2 run in full dose polycap Only patients who fulfilled >80% compliance to full dose polycap were randomized to the trial
736000|NCT01404039||
736001|NCT01403987||
736002|NCT01403948|This was an open-label trial with a dose-escalation phase according to a modified 3+3 design.|All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered to trial drug if any of the specific entry criteria was violated.
736003|NCT01403805||
736004|NCT01403610||
736005|NCT01403441|Recruitment started in August 2010, through July 2012. Subjects recruited from outpatient referrals. 5 subjects were screened, 3 enrolled.|No group assignment, open label study.
736006|NCT01403376|"The recruitment initiated in September 2011 was completed in December 2011. A total of 137 patients were screened at 14 sites in 5 countries.
~Participants treated with teriflunomide were recruited in the LTS6048-NCT00228163 study and in the LTS6050-NCT00803049 study."|"In order to ensure at least 40 participants were enrolled in the teriflunomide 14 mg group while maintaining the blind in the study LTS6050 an interactive voice response system (IVRS) was set up to include participants from both studies LTS6048 and LTS6050 into this study.
~128 participants were enrolled and vaccinated at 14 sites."
736007|NCT01403246||
736008|NCT01403194||11 subjects with a high probability of Obstructive Sleep Apnea (OSA) were consented, and all had a baseline blood draw. 2 subjects had a normal sleep study. 9 subjects had a polysomnogram suggestive of OSA, and were given the intervention of 3 months of Continuous Positive Airway Pressure (CPAP) or Bi-Level Positive Airway Pressure (Bi-PAP) use.
736009|NCT01403116||
736010|NCT01403090|Recruitment started at the Hospital Pablo Tobon Uribe and was then followed at the clinical las Americas. Eight patients were recruited in the initial phase of the study|
736011|NCT01403051|A5280 opened under version 1.0 on September 15, 2011, and the first subject was randomized on September 26, 2011. Accrual to the study closed on March 2, 2012, with a total of 167 subjects enrolled from 39 sites within the US.|Subjects were randomized with a 1:1 ratio at enrollment.
736012|NCT01402986||A total of 689 participants were screened, out of which 452 participants were randomized into this study
736013|NCT01402947||
736014|NCT01402908||
736015|NCT01402869|Patients that were greater than 3 years but less than 6 years of age that were scheduled to undergo comprehensive dental rehabilitation under general anesthesia at the Koppel Special Care Dentistry Center at Loma Linda University School of Dentistry were recruited for the study.|Enrolled participants were excluded prior to group assignment if they had a body mass index (BMI) less than the 5th percentile or greater than the 95th percentile for their age and gender.
736016|NCT01402817||
736017|NCT01402700||
736018|NCT01402570||
757778|NCT00201760|Patients were enrolled in the study from February 2005 to March 2008|
736019|NCT01402544||The Principal Investigator is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from 'UCSD' site. Data from these participants is being reported here.
736020|NCT01402531|The Investigator of this study passed away and we do not have the study data to upload the results.|
736021|NCT01402427||
736022|NCT01402375||
736023|NCT01402284||
736024|NCT01402141|Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.|The criteria were an age from 19 to 80 years, Histamine skin prick test: above 3mm
736025|NCT01402128|Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.|The criteria were an age from 19 to 70 years, BMI(Body Mass Index) >23 kg/m^2, and LDL-C(Low Density Lipoprotein-cholesterol) concentration between 110 and 250 mg/dL
736026|NCT01402115|Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.|The criteria were an age from 40 to 70 years, They were required to have reduced bone density but no evidence of osteoporosis or osteopenia by Dual-emission X-ray absorptiometry (DEXA) scan (T ≥ -1.0 in the lumbar spine).
736027|NCT01402102|Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.|The criteria were an age from 20 to 80 years, a BMI(Body Mass Index)>23 kg/m^2, an LDL-C(Low Density Lipoprotein-cholesterol) concentration between 130 and 220 mg/dL. Subjects were excluded if they had heart disease, liver or kidney disease, irregular lifestyle habits, or if they took medication and functional foods known to affect lipid metabolism
736028|NCT01402063||
736029|NCT01402050||
736030|NCT01402011|Between October 2010 and April 2012 advertisements for those between 19 and 75 years, with shoulder pain greater than 3 months, were placed in tennis courts, gymnasia, the Lions Gate Hospital Ultrasound Department, and sent to local physicians.|Clinical check R/O:unqualified participants. 77 were probable participants, pending results from their diagnostic ultrasound (delayed treatment period). 77 were ultimately enrolled in the study.
736031|NCT01401959|Between September 2011 to April 2015, 127 female patients who did not achieve a pathologic complete response (pCR i.e. have residual invasive disease in breast or lymph node tissue) after treatment with a standard neoadjuvant chemotherapy regimen and surgery were enrolled. Of those 127 patients enrolled, 126 patients received treatment.|
736032|NCT01401907||
736033|NCT01401842|Recruitment, enrollment, baseline assessments, and randomization procedures were completed during June 2012 through May 2013 at Fort Sam Houston, TX.|Assessed for eligibility: n = 698. Consented: n = 645. Deemed eligible to participate, completed baseline assessments for primary outcome, and randomized: n = 582. Reasons for ineligibility: declined to participate (n = 43), did not meet inclusion criteria (n = 28), and other or unknown reasons (n = 45).
736034|NCT01401699||
736035|NCT01401647||
736036|NCT01401595||
736037|NCT01401582|1/1/2012-12/31/2014 Screening in participating General practices (GP)|
736038|NCT01401543||
736039|NCT01401530||
736040|NCT01401517||
736041|NCT01401478||
736042|NCT01401465||
736043|NCT01401452||
736044|NCT01401361||
736045|NCT01401322||
736046|NCT01401283||
736047|NCT01401257||
736048|NCT01401166||A total of 248 participants were randomized into the study in Cohort 1 (of whom 244 were treated) and 240 participants were randomized into the study in Cohort 2 (of whom 239 were treated). Those participants who did not receive any treatment were not included in the treatment periods of the Participant Flow.
736049|NCT01401153|Participants recruited from a secondary all-day school in Gelsenkirchen, Germany in May 2011|161 participants were assessed for eligibility; 40 children refused to participate; thus 121 children started the study; one-week wash out;
736050|NCT01401101||
736051|NCT01401062||
736052|NCT01401049|Patients were recruited from Tisch Hospital, part of New York University (NYU) Langone Medical Center. An additional site was opened, Research Associates of New York (RANY). All patients having either a colonoscopy or upper endoscopy, or both, were considered.|
736053|NCT01401023|Subjects were inpatients (Sparrow Hospital) with Clostridium difficile who were treated with tigecycline. Referral base was infectious disease consultations. The first patient was enrolled 11-23-2011 and the last 9-13-2012.|
736054|NCT01401010|Subjects were inpatients (Sparrow Hospital) with febrile neutropenia who were treated with doripenem; referral base was infectious disease consultations. The first patient was enrolled 6-15-2010 and the last 8-21-2011.|
736055|NCT01400971||Participants who had complete treatment data are participants with complete insulin, oral antidiabetic medication (OAM), and glucagon-like peptide (GLP) data at all 5 visits.
736056|NCT01400958|Study was Open to Accrual at Moffitt Cancer Center 12/22/2010 to 12/28/2012.|
736057|NCT01400932||
736058|NCT01400919||
736059|NCT01400906||A total of 36 participants were enrolled; however, 1 participant was categorized as a screen failure following randomization and wasn't dosed with study drug. Thus, 35 of the 36 participants enrolled received treatment.
736060|NCT01400893||
736061|NCT01400880||
736062|NCT01400841||
736063|NCT01400698|Participants who completed 3 or 2 years treatment and at least 1 year post treatment observation in Sponsor Studies GF 4001 (Safety and Efficacy of Saizen in the Treatment of Young Children Born with Severe IUGR) or GF 6283 (Effect of Intermittent versus Continuous Saizen Therapy in Young Children Born with Severe IUGR), respectively were enrolled.|
736064|NCT01400516||
736065|NCT01400503||Participants enrolled in this study CNTO328MCD2002 included participants who were previously enrolled in study C0328T03 (NCT00412321) or CNTO328MCD2001 (NCT01024036) (either placebo or siltuximab treatment arm). A total of 60 participants from previous MCD studies C0328T03 and CNTO328MCD2001 were found eligible to be enrolled in this study.
736066|NCT01400477||
736547|NCT01370525|From total of 486 enrolled subjects, 340 subjects were randomised. From 340 subjects 171 and 169 were allocated to Esomeprazole and Placebo respectively.|
736067|NCT01400451|Study started Nov 2011; Primary Endpoint April 2013; Completed safety follow-up December 2013. Dose-limiting toxicities observed early in dose escalation (Phase I) part of the study. The combination of drugs was not well tolerated, and a maximum tolerable dose was not attained so the study was closed to enrollment and Phase II part was not started.|18 participants enrolled; 12 treated with study drug and 6 participants were not treated because they no longer met study criteria. Two of the 12 only received vemurafenib while the other 10 received the combination of vemurafenib and ipilimumab.
736068|NCT01400425||
736069|NCT01400412|A5303 opened under version 1.0 on 12/4/11, and the first participant was enrolled on 1/17/12. Accrual to the study closed on 6/12/13, with a total of 262 participants enrolled at 38 sites|
736070|NCT01400243|Female and male cannabis-dependent individuals 18 years or older were recruited by flyers and advertisements in newspapers to participate in the study in the locally well-know Southern Illinois University Integrative Neuroscience Laboratory and Smoking Lab.|During four sessions across three weeks prior to quitting the use of marijuana, subjects completed questionnaires that assessed mood, drug use, urge to use marijuana (MJ), questionnaires, and motivation to quit MJ, and provided urine, saliva, and expired breath samples for the level of marijuana and other drug use level.
736071|NCT01400139|Core study: First subject first visit: 22-July-2011; Last subject last visit: 26-August-2013. Extension period: First subject first visit: 24-April-2013; Last subject last visit of 24-February-2014. The Core and Extension studies were conducted at medical/research sites in the United States.|Subjects with moderate to severe, chronic nonmalignant and non-neuropathic pain.
736072|NCT01400113|Between 4/23/12 and 12/11/12, adult, non-pregnant patients in a Psychiatric Emergency Room were assessed by a psychiatrist for agitation. Those patients who were willing to participate and signed an informed consent were enrolled.|
736073|NCT01399905|Subjects were recruited from the Movement Disorders Clinic at Oregon Health and Science University in Portland, Oregon.|Of the 17 subjects screened, 14 subjects met enrollment criteria and were randomized into one of the two treatment arms.
736074|NCT01399866|One hundred fifty participants were enrolled (signed consent), but only 98 were found eligible and started study procedures. Eighty one participants started smoking cessation CBT, and 62 finished and were randomized to receive either D-cycloserine or identical placebo added to exposure treatment to prevent relapse to smoking.|Participants received their choice of nicotine patch or varenicline (0.5 mg per day for 3 days, 0.5 mg bid for 4 days, 1 mg bid for 4 wks) and weekly cognitive behavioral therapy for smoking cessation.
736075|NCT01399827||
736076|NCT01399788||
736077|NCT01399736||
736078|NCT01399723||
736079|NCT01399697||
736080|NCT01399619||
736081|NCT01399593|Recruitment period lasted from Nov 2011 to Mar 2014. Forty-one sites in Australia, the European Union, and North America participated in this study.|Written consent was provided prior to performing any study-required assessments (N = 275). Patients who passed screening (N = 137) underwent desensitization therapy according to local transplant center practice prior to transplantation. A total of 104 patients were randomized; of these, 102 were transplanted and received eculizumab or SOC.
736082|NCT01399268||
736083|NCT01399229||
736084|NCT01399190||
736085|NCT01399125||
736086|NCT01399099|Procedures were performed by 12 surgeons at 12 surgery centers between June 2011 and May of 2012.|
736087|NCT01399047||
736088|NCT01399008||Upon completion of screening all patients will enter into a 3-week run-in/stabilization period starting at Week -3 (Visit 1). During this phase, all patients will take allopurinol 300 mg once daily. In addition, patients will be given colchicine 0.6 mg once daily until the final study visit as prophylaxis to prevent potential gout flares.
736089|NCT01398982||
736090|NCT01398956|This study started to enroll subjects in Japan in June 2011.|Participant Flow refers to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.
736091|NCT01398943||
736092|NCT01398852|The recruitment period started December 2010 and ended June 2012 at medical clinics throughout the country.|Enrolled participants were excluded from the clinical trial because they failed to meet one or more the inclusion/exclusion criteria.
736093|NCT01398839|The recruitment period started December 2010 and ended June 2012 at medical clinics throughout the country.|Enrolled participants were excluded from the clinical trial because they failed to meet one or more the inclusion/exclusion criteria.
736094|NCT01398787|Participants were recruited from 18 US study centers.|Of the 198 enrolled participants, 1 was exited as a screen failure prior to study product exposure. This reporting group includes all enrolled and exposed participants (197).
736095|NCT01398514|Participants free of DSM-IV Axis I disorders with varying levels of subsyndromal anxiety were recruited by advertisements (e.g., postings on Craigslist, postings on Massachusetts General Hospital research participation registry) from March 2009 through April 2011.|65 participants signed consent and were screened for enrollment. 10 participants did not meet study entry criteria due to exclusionary psychiatric conditions. Of the 55 eligible participants, 3 withdrew and 1 was lost to follow up. 52 participants were randomly assigned to a treatment arm. Fourteen were excluded from analyses.
736096|NCT01398475||
736097|NCT01398410||From a total of 420 participants who completed the E3810-J081-308 (NCT01397448) study, 405 entered the E3810-J081-309 (NCT01398410) study.
736098|NCT01398358|1150 assessed for eligibility|417 declined to enroll; 36 ineligible
736099|NCT01398280||
736100|NCT01398176|Recruitment took place in October 2011. Individuals responded to posted advertisements by calling. Eligibility was determined and the individual was assigned a time to come in for the first blood draw.|52 participants were consented to the study; however, one participant who was consented was found to be in a conflicting study, and was dropped prior to the start of the study. 51 participants started the study interventions.
736101|NCT01398059||
736102|NCT01397890|There are 793 patients enrolled. 578 patients were randomized, where there are 287 patients randomized in Symbicort+ Spiriva group and 291 in Spiriva group|
736103|NCT01397851||
736440|NCT01377233||46 patients were initially enrolled in a 3-week open-label study period. The 42 patients who completed the open-label period were subsequently randomized to a 5-week double-blind period.
736104|NCT01397825|Participants took part in the Phase 1 portion of the study at 10 investigative sites in the United States from 09 August 2011 to 05 October 2016. The Phase 2 portion of the study was cancelled by the sponsor.|Participants with a diagnosis of relapsed or refractory Diffuse Large B-cell lymphoma (DLBCL)/transformed Follicular lymphoma (TFL), Mantle Cell lymphoma, or Burkitt's Lymphoma were enrolled to receive alisertib open label at doses 30 mg, 40 mg or 50 mg.
736105|NCT01397786|This trial was conducted in a total of 1072 participants (1044 of whom entered the open-label treatment phase) at 202 trial sites in the following 18 countries: Japan, Korea, Malaysia, Philippines, Taiwan, Croatia, Latvia, Poland, Romania, Russia, Serbia, Turkey, Ukraine, Columbia, Mexico, Canada, Puerto Rico, and United States of America (USA).|Enrollment was drawn from eligible participants who could potentially benefit from monotherapy treatment with oral brexpiprazole for schizophrenia and included rollover participants from the double-blind, phase-3 efficacy trials (ie, Trial NCT01393613, Trial NCT01396421, and Trial NCT01668797) and de novo participants from select sites.
736106|NCT01397747||12,776 participants provided written informed consent. 1,760 could not be evaluated (464- withdrew consent, 1,168- did not undergo colonoscopy, 128- did not submit stool sample).
736107|NCT01397695||The Responsible Party for this record has passed away in 2013. There are no study team members still associated with this study at the institution. There have been no publications, and the study data cannot be located.
736108|NCT01397656||
736109|NCT01397617||
736110|NCT01397591||3 subjects enrolled on study but 1 of the 3 was a screen failure so only 2 subjects were assigned to study treatment.
736111|NCT01397552||
736112|NCT01397461|Patients were enrolled at 27 sites in the USA, Germany, Romania, Ukraine, and South Africa.|
736113|NCT01397448||
736114|NCT01397422|Participants with Parkinson's disease (PD) and Levodopa-induced Dyskinesia (LID) were enrolled at 31 study sites in the United States. The first subject was randomized on 03 August 2011 and the last subject completed on 15 April 2013.|All randomized subjects (83) were treated and analyzed for safety; 80 were analyzed for efficacy and included in the Modified Intent to Treat (MITT) population. Subjects in the MITT had mild to severe dyskinesia, had periods of troublesome dyskinesia during the day, received ≥ 1 dose of study drug, and provided ≥ 1 postbaseline efficacy assessment.
736115|NCT01397409||
736116|NCT01397253||
736117|NCT01397084|First participant enrolled on 25 August 2011. Last participant completed on 31 January 2012. Out of 108 enrolled participants, 107 participants (target was 100) received esomeprazole 20 mg. All of the participants were included in safety analysis set and 104 out of the 107 participants were included in the full analysis set for efficacy analyses.|Participants with a history of reflux oesophagitis and with continuing heartburn after previous treatment with rabeprazole 10 mg were included in this study.
736118|NCT01397071|The enrollment period was 8/2011 to 2/2012. Enrollment took place in a private setting in the clinic located at the site.|17 healthy male volunteers were recruited and screened; 6 failed screen; 11 participants completed crossover study.
736119|NCT01396837||
736120|NCT01396551||Patients meeting inclusion/exclusion criteria and enrolled in the study were implanted with anchored transponders unless the patient's status changed prior to implantation. For example, if the patient's therapeutic plan was changed to exclude radiotherapy or the patient receives chest implants that preclude them from the study.
736121|NCT01396525|Subjects with chronic lower extremity peripheral arterial disease (PAD) admitted for percutaneous CIA or EIA revascularization were screened for eligibility. Subjects who met all general and clinical eligibility criteria, and signed the informed consent, underwent arteriography of the target iliac artery.|
736122|NCT01396512|The study participants were enrolled from 12 July 2011 to 28 September 2012 at 10 clinic centers in South Korea.|A total of 274 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
736123|NCT01396486||While 69 subjects enrolled in the study, only 61 were randomized. Of the 8 subjects who enrolled but were not randomized, 3 were found ineligible, 3 withdrew, and 2 were lost to follow-up.
736124|NCT01396447|Adult participants with a diagnosis of bipolar I disorder with a current major depressive episode were considered for participation in the study.|
736125|NCT01396434||
736126|NCT01396421|The trial was conducted in 636 participants from 65 trial sites in 10 countries.|Adults with schizophrenia as defined by Diagnostic and Statistical Manual of Mental Health Disorders 4th Edition Text Revision criteria and confirmed by the Mini International Neuropsychiatric Interview for schizophrenia and psychotic disorders studies.
736127|NCT01396395||4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received. Thus, safety set have 197 and 205 in Standard+nicorandil and standard group, respectively.
736128|NCT01396382|This diagnostic study was conducted at Vanderbilt University/Ingram Cancer Center from March 2011-November 2013, at which time the study met target accrual and closed to accrual.|Ninety-nine patients were consented on this trial. Two consented patients were determined not eligible resulting in 97 patients on study.
736129|NCT01396317||
736130|NCT01396265||
736131|NCT01396239||
736132|NCT01396226|The study had enrolled 20 patients. A total of 18 patients were randomised of which 12 patients received AZD2927. All patients who received treatment completed the study.|
736133|NCT01396187|Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM), diagnosed according to the American Diabetes Association (ADA) guidelines, those with well controlled diabetes and were on stable metformin therapy were recruited in the study.|Dose of PF-05231023 was escalated based on sponsor's and investigator's discretion, depending upon safety, tolerability and pharmacokinetic profile of PF-05231023.
736134|NCT01396161||
736135|NCT01396148||
736136|NCT01396083||
736137|NCT01396070||
736138|NCT01396057||
736177|NCT01394003||Parts A and B of the study were conducted to determine the dose and dosing schedule to be used in Part C (dose confirmation phase). The decision to initiate Part B was based on the safety, pharmacokinetic, and pharmacodynamic results in Part A. The study was terminated prior to participant enrollment in Part C of the study.
736139|NCT01396044|All patients admitted to the MICU service at Northwestern Memorial Hospital on or after June 27, 2011 and discharged on or prior to October 7, 2011 were enrolled. Exclusion criteria: patients transferred to or from a different ICU service, and MICU re-admission without intervening hospital discharge.|Patients were included only if they were treated with at least one day of empirical antibiotics.
736140|NCT01396005||
736141|NCT01395966||
736142|NCT01395914|Patients who completed dosing in either of the original trials of anamorelin HCl in the treatment of NSCLC-C (HT-ANAM-301 or HT-ANAM-302) were able to enroll in this study and continue to receive the study drug to which they were assigned, either anamorelin HCl 100 mg or placebo QD for an additional 12 weeks.|The primary purpose of this extension study was to permit patients who completed dosing in the original 12-week trials to have the option of continuing to receive randomized study drug for an additional 12 weeks, to further evaluate the safety and tolerability of anamorelin HCl.
736143|NCT01395901|A total of 44 sites were initiated in seven countries with 12, 9, 5, 5, 5, 6 and 2 investigative sites in the United States, Ukraine, Hungary, Poland, Russia, Czech Republic and Argentina. Patients were enrolled into the study by 39 out of 44 Investigators enrolling at least one patient.|
736144|NCT01395888|A total of 260 participants were randomized. Three of these participants were randomized in error (they were determined not to have met entry criteria and were classified as run-in/screen failures); thus, they did not receive investigational product and are not captured in the Treatment Period table of the Participant Flow module.|At Visit (V) 1, eligible participants (par.) entered a 2-week, single-blind placebo Run-in Period (RIP) to establish a stable baseline. At V 2, eligible par. were randomized to a 12-week, double-blind, double-dummy Treatment Period. 802 par. were screened, 279 par. entered the RIP, and 257 par. were randomized and received >=1 study treatment dose.
736145|NCT01395823||470 subjects were enrolled in the study; however 151 subjects did not make it to randomization due to EPO criteria not met n=45, did not meet other inclusion criteria n=57, no was reason provided n=49. Of the 319 subjects randomized, 43 had a baseline 25(OH)D >30. This analysis only pertains to the 276 subjects with a baseline 25(OH)D ≤30.
736146|NCT01395810|The trial was conducted at 41 sites in 15 countries as follows: France: 1 site; Germany: 3 sites; Italy: 2 sites; Japan: 4 sites; Macedonia: 2 sites; Malaysia: 1 site; Netherlands: 1 site; Romania: 1 site, Russia: 1 site; South Africa: 1 site; Taiwan: 1 site, Thailand: 2 sites; Turkey: 3 sites; United Kingdom: 5 sites; United States: 13 sites|A total of 71 unique subjects were dosed during this trial. During the trial, subjects were free to switch between treatment arms if agreed between the investigator and the subject. Subjects who switched arms were represented in multiple arms.
736147|NCT01395797||
736148|NCT01395784||
736149|NCT01395758||
736150|NCT01395537|Participants were recruited from medical clinic from 8/2011 to 4/2013.|
736151|NCT01395524|This multicenter study was conducted in the United States between 07 July 2011 and 13 September 2012.|Study D380C00007 is an extension study of D3820C00004. Of the patients randomized in D3820C00004, n=302 continued and enrolled into D380C00007. The study duration was up to 14 weeks, consisting of a 12 week treatment period and a follow-up visit 2 weeks after the last dose of study drug.
736152|NCT01395394||
736153|NCT01395368|Participants were recruited from Washington University's Volunteer for Health office, the audiology division and the otolaryngology faculty clinical practices at Washington University Department of Otolaryngology-Head and Neck Surgery, including the PI's population of tinnitus patients.|
736154|NCT01395329||
736155|NCT01395316||
736156|NCT01395277||
736157|NCT01395043||
736158|NCT01395030||
736159|NCT01395017|202 participants were enrolled at 79 study sites in 15 countries.|Participants were randomly assigned in a 1:1 ratio to receive dasatinib + gemcitabine (GEM) or placebo + GEM. Participants were stratified at the time of randomization by baseline Eastern Cooperative Oncology Group performance status (ECOG PS) (0 versus 1) and intent to receive radiotherapy (RT) (yes or no).
736160|NCT01394991|This is a randomized, open-label, multicenter study evaluating thrombovascular events in participants with cancer receiving chemotherapy and administered Epoetin Alfa once weekly (QW) or three times a week (TIW) for the treatment of anemia.|
736161|NCT01394978||
736162|NCT01394952||Participants were randomized to either placebo or Dulaglutide. Completers included participants for whom vital status was ascertained during the study close-out period and endpoint completers.
736163|NCT01394926|21 Subjects enrolled in study. 21 subjects completed this study. 0 subjects did not complete the study.|
736164|NCT01394718|All children of ages 10-18 undergoing posterior spine fusion surgery for idiopathic or neuromuscular scoliosis between July 2011 and May 2014 were eligible for inclusion.|281 subjects were screened, 125 approached for consent/assent and 67 consented/assented. Of the initial 67 subjects, 1 was withdrawn by the clinical team, 1 patient's surgery was cancelled, 2 were withdrawn by the family, and 3 were deemed ineligible after consent were removed from the study.
736165|NCT01394705|38 completed study, 21 randomized to each group, 2 lost to follow-up in each group with an N of 19 in each group.|
736166|NCT01394692||
736167|NCT01394627||
736168|NCT01394614||
736169|NCT01394523||
736170|NCT01394510||
736171|NCT01394276|A total of 322 participants were enrolled across 59 study centers in Italy from 31 May 2011 to 24 April 2013.|
736172|NCT01394250|Potential subjects were identified in the Emergency Department (ED) from 2011-2014. When ED nurse anticipated intravenous (IV) placement, a member of the study team was contacted to screen for study eligibility.|A total of 315 subjets signed informed consent forms. Of these 47 subjects were excluded prior to initiation of study procedures. Reasons included parent/child withdrawal of consent, change in clinical treatment plan including the decision to not place an IV for clinical reasons (study exclusion).
736173|NCT01394211|Through physician|
736174|NCT01394185||
736175|NCT01394159||
736176|NCT01394081|Rural veterans unlikely to be currently receiving VHA services were targeted for outreach, and therefore, recruitment design did not represent a population-based sampling strategy.|
736990|NCT01344057|Overall, 63 participants were ≥65 years of age were enrolled at 4 sites in Italy.|Blood sample for immunogenicity assays were collected before vaccination (Day 1) and after 21 Days.
736178|NCT01393990||The study had 4 parts, dose-escalation (Part A), 2 dose-confirmation (Parts B and C), and a tumor-specific expansion for metastatic breast cancer (Part D). Completers for Parts A and D were defined as any participant who completed Cycle 2 or had a dose-limiting toxicology (DLT) in Cycle 1 and did not enter Cycle 2.
736179|NCT01393964||35 participants were enrolled; 9 did not enter into the treatment period. Reasons for not entering treatment period: 8 no longer met criteria, 1 other.
736180|NCT01393899||
736181|NCT01393821||
736182|NCT01393743||Of the 307 participants who were screened, 143 participants were screen failures and 164 participants were eligible to continue in the study but 1 participant withdrew prior to receiving treatment.
736183|NCT01393730|Patients enrolled from September 2011 through October 2012|
736184|NCT01393717||
736185|NCT01393704||
736186|NCT01393626||280 participants were randomized to treatment but only 279 participants received treated.
736187|NCT01393613|This trial was conducted in 674 participants from 68 trial sites in 8 countries.|Adults with schizophrenia as defined by Diagnostic and Statistical Manual of Mental Health Disorders 4th Edition Text Revision criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) for schizophrenia and psychotic disorders studies were included.
736188|NCT01393600|This study enrolled patients with a clinical diagnosis of schizophrenia or schizoaffective disorder with moderate or severe symptoms of tardive dyskinesia (TD) from 10 centers in the United States. The last patient completed in February 2012.|
736189|NCT01393457||119 were enrolled (that is, signed the consent); however, only 110 were randomized. Of the 9 that were not enrolled but not randomized, 1 was no longer interested after signing the consent, and 8 were lost to follow up.
736190|NCT01393444|Recruitment included interfacing with local research registry participants, clinical SCI physicians, MDS and ALS groups, and attending conferences attended by eligibility populations|"This study did not include arms or group assignments."
736191|NCT01393405|256 patients were assessed for eligibility between February 2012 and May 2016 at 37 sites across the US. 76 met exclusion criteria and one patient withdrew consent during screening.|
736192|NCT01393392||
736193|NCT01393301||72 participants were officially consented, 71 participants completed baseline (1 lost to follow-up), and 53 participants attended Session 1 after baseline (10 found ineligible at baseline, 8 lost to follow-up). Randomization occurred at the end of Session 1; therefore, only participants who attended Session 1 (N=53) were randomized.
736194|NCT01393158||
736195|NCT01393132|"Recruitment Details The study took place at Kresge Eye Institute by Dr. Gabriel Sosne, and at Michigan Cornea Consultants, P.C. by Dr. Steven P. Dunn,
~The first subject was screened on Mar.2011 and the last subject last visit to the clinic was on Dec.2012"|"Pre-assignment Details:
~Subjects were evaluated upon entering the study after a two week washout period."
736196|NCT01393106|Participants were enrolled at study sites in the United States. The first participant was screened on 15 September 2011. The last study visit occurred on 28 August 2014.|32 participants were screened.
736197|NCT01392989||
736198|NCT01392963|Participants were recruited from local outpatient psychiatry and primary care practices, and through internet advertisements and media appearances.|A total of 101 were screened via telephone, 39 received a face-to-face screening interview, and 30 were enrolled in the study.
736199|NCT01392742||
736200|NCT01392703||A total of 141 participants were enrolled, of which 78 were randomized to and received treatment in 1 of 6 sequences(ABC, ACB, BCA, BAC, CAB, or CBA), administered over 3 1-day treatment periods (Days 1, 5, and 9), with treatment changing to next in the sequence at start of each new period. A 3-day washout period followed treatment periods 1 and 2.
736201|NCT01392677|First participant enrolled: 24 Oct 2011. Last participant completed 24 week period: 07 Jan 2013. 311 participants were enrolled, 219 were randomized in 45 centers in 5 European countries and in North America. Men and women aged >= 18 years with inadequate glycemic control (HbA1c 7.0% to 10.5% prior to randomization).|During enrollment, diet and life-style advice was given to participants and was reinforced during a placebo lead-in period. Dose of anti-hyperglycemic combination therapy of metformin >= 1500 mg/day and maximum tolerated dose which must be at least half the maximum dose of sulfonylurea for at least 8 weeks prior to enrollment were to remain stable.
736202|NCT01392625||
736203|NCT01392573|The trial was conducted at 75 sites in 7 countries: Bulgaria (6), Switzerland (2), Denmark (3), Hungary (3), India (6), Slovenia (3), and the United States (52).|
736204|NCT01392560||
736205|NCT01392547|Patients treated with vatreptacog alfa were recruited from a total of 46 sites globally in 18 countries, including Austria, Brazil, Croatia, Greece, Hungary, Italy, Japan, Malaysia, Poland, Romania, Russia, Serbia, South Africa, Taiwan, Thailand, Turkey, United Kingdom and United States of America.|
736206|NCT01392495||
736207|NCT01392443|A total of 110 patients were planned, 120 patients were enrolled and analyzed.|
736208|NCT01392378||
736209|NCT01392326||
736210|NCT01392300||
736211|NCT01392170|Recruitment Period: October 28, 2011 to March 28, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Study was terminated due to slow accrual.
736212|NCT01392053|This was a randomized and controlled non-inferiority clinical trial with a blind rater involving comparative analysis of a study group and a control group. The study included 46 parturients admitted to the Reference Center of Women's Health of Ribeirão Preto-MATER, state of São Paulo, Brazil, during the period from September 2009 to May 2010.|149 women in labour were eligible, were excluded because their women 103 not attended the criteria for inclusion (primigesta, single fetus cephalic position, low-risk pregnancy, least 37 weeks, cervical dilation 4-5 cm, spontaneous onset of labor, no use of medication during the study period, intact membranes, and no associated with risk factors).
736213|NCT01391858|In recent years, surgical techniques have evolved from mastectomy with lymph node dissections to other forms of less invasive or nonsurgical techniques and these changes reduced the number of patients getting an axillary lymph node dissection (personal communication with the study-associated surgeon).|A total of 80 patients were consented. 7 patients did not show up for surgery. Of the 73 patients randomized, only 49 received intervention. The remaining 24 either had their surgery cancelled, withdrew their consent before intervention, or did not receive the loading dose in time to continue with the study.
736214|NCT01391832|Veterans previously deployed to combat regions from 2001 to present (e.g., Operation Enduring Freedom (OEF), Operation Iraq Freedom (OIF), and Operation New Dawn (OND) with current combat-related PTSD symptoms were recruited from the community.|
736215|NCT01391819||Out of 2117 subjects enrolled in the study, one subject was excluded due to protocol violation. Subjects attended 3 to 4 visits, during a 2 to 3 Year period: subjects enrolled in 2011-2012 who consented for participation of one additional year had 4 scheduled visits over 3 years, and those enrolled in 2013 had 3 scheduled visits over 2 years.
736216|NCT01391793||
736217|NCT01391663|Participants took part in the study at a single investigative site in South Korea from 25 July 2011 to 02 September 2011.|Healthy Korean participants were enrolled in either alogliptin 12.5 mg, 25 mg or 50 mg once-daily (QD) treatment groups.
736218|NCT01391611||
736219|NCT01391559|Recruitment dates: July 2011 to October 2012; Location: medical clinic|26 patients screened: 5 excluded because did not meet exclusion criteria; 1 excluded because of exacerbation after visit 1.
736220|NCT01391546||
736221|NCT01391507||
736222|NCT01391468||
736223|NCT01391364|There were 438 eligible participants (876 eyes) enrolled.|
736224|NCT01391325||1,735 subjects enrolled in the study; however, only 1,732 were treated. Therefore, 1,732 subjects started the treatment period.
736225|NCT01391312||
736226|NCT01391299||
736227|NCT01391286||
736228|NCT01391273||
736229|NCT01391130||Participants who died (any cause) or had disease progression at the time the primary analysis were considered to be study completers.
736230|NCT01391013|30 participants were enrolled at a single site in Italy.|30 participants were randomly assigned to 2 treatment groups (15 participants in each group) and all participants received the study medication.
736231|NCT01391000||
736232|NCT01390948||Chemoradiation + temozolomide (TMZ) and Chemoradiation + Bevacizumab + TMZ arms: 174 participants were screened; 121 were randomized; 116 received study treatment. Young Patient Cohort: 4 participants were screened; 3 were enrolled and received study treatment (these subjects were not randomized and are not included in efficacy analyses).
736233|NCT01390909||
736234|NCT01390870||Participants were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a participant cohort. All diagnoses and treatment are recorded in the course of routine medical practice.
736235|NCT01390857||This post-marketing surveillance (PMS) study was designed to evaluate the safety and efficacy of valaciclovir in pediatric participants with chickenpox.
736236|NCT01390844|Adult participants in an Asia Pacific population with chronic Hepatitis C (CHC) genotype 1 who have failed prior treatment with pegylated interferon and ribavirin (PR) were selected to participate in this study.|Of 282 participants randomized and treated, 269 participants followed Good Clinical Practice (GCP); 13 participants did not follow GCP.
736237|NCT01390818|First subject (informed consent): May 2011. Study completion date: Apr 2015. A total of 192 subjects were screened and 146 subjects entered the trial and received the investigational medicinal product (IMP).|Study had a 4-day Drug-Drug Interaction (DDI) period, within 1 week prior to Day 1 Cycle 1, to assess possible interaction only in selected subjects where in SAR245409 and Pimasertib were administered alone on Day 1 and Day 3, respectively.
736238|NCT01390779|Recruitment from July 2011 to May 2012, from medical clinic and investigator's patient database.|Regular sleep cycle in the week preceding the study.
736239|NCT01390649||Screening occurred within 6 days before treatment with IgPro10 (Privigen). Subjects who met all of the inclusion criteria and none of the exclusion criteria could be enrolled into the study. Of 58 eligible subjects, one withdrew consent before treatment and 57 subjects received at least 1 dose of Privigen.
736240|NCT01390584|This study was activated on April 2, 2012 and closed on January 24, 2014 with a final accrual of 6 patients.|
736241|NCT01390441|The study enrolled participants 18 to 65 years of age with a diagnosis of moderate/severe rheumatoid arthritis (RA), naive to treatment or having failed >=1 anti-TNF agent, and on a stable dose of methotrexate. Not all participants completing the Treatment Period entered the Extension Period due to study early termination.|For Part B only, positive for rheumatoid factor (RF) or, if negative for RF, positive for anti-cyclic citrullinated protein antibodies at the screening visit.
736242|NCT01390428||
736243|NCT01390415|All the medical charts of the targeted study patients were reviewed. The study index period (when patients had to have received treatment for 6 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively.|211 patients were enrolled in this study. Among these patients, 136 patients were eligible after excluding 75 patients.
736244|NCT01390402|Recruitment Period: January 24, 2012 to August 1, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
736245|NCT01390389|Bipolar subjects were recruited from the McLean Hospital Geriatric Psychiatry Inpatient and Outpatients services, and similar external programs, as well as through radio and internet advertisements. Controls through contacts with the Harvard Division on Aging, local retirement communities and advertisements on the internet, and senior centers.|Subjects who met DSM-IV diagnostic criteria for Bipolar Disorder and were currently depressed episode were assigned to the CoQ10 group. The CoQ10 group was to receive CoQ10 therapy for 4 weeks. Healthy control subjects no evidence of current or past psychiatric disorders were assigned to the Control group. This group did not receive CoQ10 therapy.
736246|NCT01390298||
736247|NCT01390272|The study was conducted among patients receiving primary care at the Durham VAMC, including VA Community Based Outpatient Clinics (CBOC).|
736248|NCT01390259||
736249|NCT01390246|Pregnant smokers were recruited through the UTMB Ob/Gyn Department clinics and Regional Maternal Child Health Program (RMCHP) clinics. The study was also advertised through printed flyers, posters, and electronic media in clinic waiting areas. UTMB OB providers were notified of the study as well to refer potential participants.|Psychological screening using the PRIME MD survey was administered after enrollment at the first Study Visit. Using the score, subjects with evidence of major depression or any other severe, acute psychiatric symptom (eg, psychosis) were considered screen failures and referred back to their prenatal provider for treatment.
736250|NCT01390233||
736251|NCT01390220||Participants underwent in-clinic administration of open-label USL261 5 mg followed by USL261 5 mg 10 minutes in absence of a seizure (Test Dose Phase [TDP]). Participants were then randomized to double-blind USL261 5 mg or Placebo to be administered by caregiver to treat a seizure cluster in Comparative Phase (CP) in the outpatient setting.
736252|NCT01390181||
736253|NCT01390064||
736254|NCT01390038||
736255|NCT01389973|The study had 2 parts, Part 1 (proof of concept) and Part 2. As per the study design, the study was considered completed after part 1 and part 2 was not initiated. Results shown below are for Part 1 of the study.|
736256|NCT01389882|Participants recruited from a neonatal intensive care unit (NICU) of Seoul National University Hospital, in Seoul, Republic of Korea between March 2011 to July 2011.|26 patients enrolled; 24 assigned to randomization and 2 excluded (1 extubated prior to the study and 1 developed exclusion criteria)
736257|NCT01389856|First patient, first visit was 8 December 2011 and last patient, last visit was 5 December 2013. The investigational sites were tertiary care centers with neonatal intensive care unit facilities at which inhaled nitric oxide (iNO) was used as standard of care for persistent pulmonary hypertension of the newborn (PPHN).|Term or near-term (gestational age > 34 weeks) hypoxic newborns with respiratory distress refractory to supplemental oxygen were considered, provided they had no significant structural cardiac anomalies documented in the pre-natal period and had no immediate need for extra corporeal membrane oxygenation (ECMO).
736258|NCT01389817||
736259|NCT01389765||
736260|NCT01389752||
736261|NCT01389596||
736262|NCT01389323|The study was conducted at 33 clinical sites in United States.|A total of 448 participants were enrolled, and 246 entered treatment period. Remaining 202 did not enter treatment period (29: withdrew consent, 17: lost to follow-up, 156: no longer met study criteria). As per protocol, any participant who discontinued the treatment period was still expected to enter the post-treatment follow-up period.
736263|NCT01389284||
736264|NCT01389258||
736265|NCT01389245||
736266|NCT01389128||
736267|NCT01389102|Participants were recruited from 43 physicians' offices, or their affiliated locations, within the United States between 17 December 2004 and 09 March 2006|Participants underwent a four week screening period to determine eligibility prior to assignment into the study.
736268|NCT01389076||
736269|NCT01388985||2 participants (1 in each group) signed the ICF and were randomized, but withdrew their consent before the first vaccination. They are not included in any of the analyses.
736270|NCT01388946||
736271|NCT01388920||
736272|NCT01388907|First patient included: 16 May 2006 Last patient included: 13 June 2008 11 participating centres, Hopsital|
736273|NCT01388816||
736274|NCT01388790|First/last participant (informed consent): 29 June 2011/16 January 2012; Clinical data cut-off: 14 August 2012; Study completion: 13 May 2013.|Enrolled: 41 screened for eligibility; 1 excluded (non-fulfillment of inclusion or exclusion criteria) and 40 participants included in the study.
736275|NCT01388777|Ten participants are required for analysis. Patients over 18, with invasive ductal carcinoma with less than or equal to 2 cm residual disease after neoadjuvant treatment, among other criteria are eligible.|Early termination leading to small number of subjects analyzed.
736276|NCT01388647|This study was open to enrollment at four community oncology centers in the United States from July 2011 to June 2014.|Informed consent was obtained from all subjects. Subjects must have had no prior treatment for invasive breast cancer.
736277|NCT01388543||
736278|NCT01388530|Recruitment was initiated in July 2011 and ended in October 2012. Participants self-identified or were referred from community providers in response to public advertisements.|Following informed permission/assent participants were assessed for eligibility and if meeting inclusion/exclusion criteria initiated 8 weeks of open-label Trigeminal Nerve Stimulation (TNS) treatment.
736279|NCT01388491|Of the 351 healthy women screened for enrollment, 293 at 26 centers in the European Union (EU) (21 centers) and Israel (5 centers) met entry criteria and were considered to be eligible for this study.|Of the 58 women who were screened but not randomly assigned to receive treatment, 10 were excluded on the basis of inclusion/exclusion criteria, 32 withdrew consent, and 6 were lost to follow-up before the baseline visit. An additional 10 participants were not randomly assigned to treatment for other reasons.
736280|NCT01388361|The trial was conducted at 119 sites in 12 countries: Austria (4), Belgium (4), Canada (15), Czech Republic (4), Denmark (6), Finland (6), France (4), Germany (12), Norway (6), Serbia (5), Spain (7) and United States (46). These sites enrolled subjects in the randomised or non-randomised arms of the trial.|Subjects treated with Insulin degludec (IDeg) once daily (OD) + metformin in trial NN1250-3643 (NCT01193309) were eligible for this trial. Eligible subjects with an HbA1c >/=7.0% at the end of 3643 trial were qualified to enter the extension trial 3948 and be randomised to add either liraglutide/insulin aspart to their prior IDeg + Met treatment.
736281|NCT01388335||
736282|NCT01388166||
736283|NCT01387815||Of the 662 patients enrolled, the Safety Analysis Set included all who signed the inform consent and received at least 1 dose of study medication (N = 658) and the Intent-to-Treat Population included all who signed informed consent, met the inclusion / exclusion criteria, and received at least 1 dose of study medication (N = 595).
736284|NCT01387789||
736285|NCT01387737||
736286|NCT01387672||Initial run-in period-subjects received, in random order, each of the 5 nitrate formulations for 2 days with a 2 day wash out period between formulations. There were 265 subjects enrolled in the run-in phase of the study. Out of those, 229 subjects entered the treatment phase of the study, where they were randomized to one of the 6 treatment arms.
736287|NCT01387607||A total of 431 participants were screened and 343 of these were randomized. A total of 334 participants received the assigned study treatment.
736288|NCT01387594||
736364|NCT01382251|Patients > 65 yrs scheduled to undergo elective ambulatory orthopedic or peritoneal surgeries were assessed for eligibility. Each patient must have a partner or adult descendant as primary caregiver. Patient-caregiver dyads were approached in the pre-admission unit. Screening began on 2010-07-01 and the final assessment was completed on 2012-01-04.|
736991|NCT01343901||
736289|NCT01387581|Dermatologists were selected at random from Germany's public dermatology membership list and were invited to participate by letter. Those interested in participating were asked to register online. Eligible dermatologists were selected to participate on a first-come basis and were divided by random placement into one of two study arms.|Dermatologists interested in participating were asked to register online by responding to an Intake Survey. The survey included questions about dermatology training, medical licensure, board certification, and comfort with and frequency of screening for melanoma. Only board certified dermatologists were permitted to participate in the study.
736290|NCT01387542||
736291|NCT01387516||18 participants who were enrolled and completed the baseline assessment either withdrew or were lost prior to treatment assignment.
736292|NCT01387464||
736293|NCT01387347|The study took place at Ora Clinical Research and Development (a medical clinic)by Dr. Gail Torkildsen.The first subject was screened on 13 August 2011 and the last subject last visit to the clinic was on 20 September 2011.|Subjects who initially qualified for study entry, had adequate baseline staining and redness and positive controlled adverse environment response, were instructed to discontinue all ophthalmic medications and instill a commercially-available sterile irrigating (balanced salt) solution (i.e., the run-in solution) twice a day until Visit 2, Day 0.
736294|NCT01387282|Approximately 477 patients with advanced NSCLC-C (defined as unresectable Stage III and Stage IV and a weight loss of ≥ 5% body weight within 6 months prior to screening or a screening body mass index [BMI] < 20 kg/m2) were to be randomized 2:1 to anamorelin HCl 100 mg or placebo.|Central randomization stratified patients by geographic region, by chemotherapy and/or radiation therapy status and by weight loss over prior 6 months.
736295|NCT01387269|Approximately 477 patients with advanced NSCLC-C (defined as unresectable Stage III and Stage IV and a weight loss of ≥ 5% body weight within 6 months prior to screening or a screening body mass index [BMI] < 20 kg/m2) were to be randomized 2:1 to anamorelin HCl 100 mg or placebo.|Central randomization stratified patients by geographic region, by chemotherapy and/or radiation therapy status and by weight loss over prior 6 months.
736296|NCT01387230||Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 5- to 9-day run-in period and were then randomized to a 12-week treatment period. A total of 246 par. were screened; 206 par. who were eligible were randomized and 206 par. received at least one dose of study drug.
736297|NCT01387178||Participants were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
736298|NCT01387139||
736299|NCT01387074||
736300|NCT01387022|Two arm, open-label, randomised controlled trial|A total of 214 participants were assessed for eligibility: 60 were excluded due to high CD4+ count, 30 were already on ART, 8 were loss to follow-up and 43 refused participation. Of the 73 that were screened, 8 were screen failures due to high CD4+ count, 4 refused participation, 1 was very ill with TB and 1 could not be contacted.
736301|NCT01386983||
736302|NCT01386970||
736303|NCT01386944|"This non-interventional study (NIS) was conducted in 18 specialized centres (medical practice and outpatient department) for neurology throughout Germany.
~The Participant Flow refers to the Enrolled Set (ES). The ES consists of all patients who provided informed consent."|The physician was to decide freely to treat the patient with Neupro®. In this context, the physician was not to change routine practice in reaching treatment decisions and in treating his/her patients because of the study. The observational period was 13 months per patient (adjustment period of medication switch plus 12 months of observation).
736304|NCT01386788|102 patients were enrolled, data of 100 patients were evaluated|
736305|NCT01386684||
736306|NCT01386658|The study was conducted at 27 study centers in the United States, Germany, Israel, Spain, Argentina, Australia, Austria, Canada, Colombia, Hungary, and Italy between 27 January 2012 (first participant first visit) and 12 March 2018 (last participant last visit).|A total of 32 participants were enrolled and received treatment.
736307|NCT01386645||
736308|NCT01386632||
736309|NCT01386606||
736310|NCT01386554|Participants were enrolled at study sites in United Staes. The first participant was screened on 20 October 2011. The last study visit occurred on 05 May 2017.|132 participants were screened.
736311|NCT01386528|The study was conducted at 10 sites in 8 countries : Italy (1 site), Malaysia (1 site), Romania (1 site), South Africa (1 site), Taiwan (1 site), Turkey (1 SIte), UK (2 sites), US (2 sites).|Patients enrolled in the present trial were recruited from the pivotal trial (NN7999-3747) or the extension trial (NN7999-3775). In addition, new patients were recruited into the present trial.
736312|NCT01386125||
736313|NCT01386008|28 recruited, 4 disqualified due to significant anterior ocular health findings, 4 passed screening and scheduled for lense fit/dispense when study discontinued.|
736314|NCT01385995||
736315|NCT01385748|183 participants were randomized from 6 countries during 4 years|
736316|NCT01385696|This study was conducted 4 centres, 2 in The Netherlands and 2 in Germany. The first patient was screened in June 2011 and the last patient visit was in January 2012.|
736317|NCT01385644|All Participants known to doctors through standard of care appointments in clinic.|All patients meet all inclusion criteria and none of the exclusion criteria.
736318|NCT01385579|All eligible patients within the health center were randomized to usual care or care manager outreach. Eligibility for randomization was assessed on 12/31/2009. Outreach was conducted from 2/25/2010 through 4/30/2010.|
736319|NCT01385566||
736320|NCT01385371||
736321|NCT01385306||
736322|NCT01385293||
736323|NCT01385280||
736324|NCT01385202|The first subject was enrolled on June 02, 2011. Twenty-one (21) sites enrolled subjects. Last patient enrolled on December 22, 2011. Last procedure on December 29, 2011.|
736325|NCT01385189||
736397|NCT01380093||
736441|NCT01377194|Patient recruitment occurred during a 6 month period from June to December 2011 at 47 study sites in the United States and 4 study sites in Canada.|All patients went through a 1-week single-blind placebo run-in period before randomization.
737142|NCT01335581||
736326|NCT01385176|"Enrollment Start: 21-Sep-2011. First implant: 28-Sep-2011.Last Implant: 20-June-2013.
~118 patients enrolled, 96 were found to be eligible and were implanted across 24 centres (7 sites with 5-10 implants, 1 site with 13 implants).
~95 patients were randomized."|"22 patients were excluded after enrollment. 18 patients did not meet the inclusion criteria. 4 patients decided to withdraw their consent.
~96 patients were finally implanted with the investigational device. One patient died after implant and before randomization. Randomization was done only after the investigational device implant had occurred."
736327|NCT01385137||
736328|NCT01385098||
736329|NCT01385033||Part II and III were not conducted due to early termination of the study
736330|NCT01384877||One (1) participant signed the informed consent form but withdrew from the study before receiving any treatment.
736331|NCT01384760|A total 185 patients were screened and 104 underwent randomization|
736332|NCT01384734|Participants with Human Immunodeficiency Virus (HIV-1) were randomized in ratio of 1:1:1:1:1 to 5 treatment arms of the study. Four groups with distinct dose of Fostemsavir (FTR, also referred BMS-663068) with Raltegravir (RAL) Tenofovir Disoproxil Fumarate (TDF). There was a reference group with ritonavir (r) boosted atazanavir (ATV), RAL and TDF.|A total of 581 participants were screened, 254 were enrolled of which 2 participants withdrew consent and 1 was randomized in error. A total 251 participants were randomized and treated of which 32 were in Monotherapy sub-study (only FTR) and continued to Primary study.
736333|NCT01384591||
736334|NCT01384539||
736335|NCT01384292|This multicenter study was conducted in Poland, the Czech Republic, and the United States between 29 June 2011 and 20 September 2012. Due to recruitment challenges, enrollment to this study was stopped early and no new patients had been screened as of 20 April 2012. Fourteen patients were randomized across the 3 treatment groups.|Part A was 8 weeks: 14-day screening period, 2-week OIC confirmation period, 4-week treatment period. Part B was 14 weeks: 12-week treatment period, 2-week follow-up period. Part B was optional for eligible patients completing Part A. NKTR-118 patients from Part A remained on the same NKTR-118 dose, while placebo patients received NKTR-118 25 mg.
736336|NCT01384019|Between Jan 24, 2004, and June 16, 2008, 550 patients with STEMI were screened.|Among them, 126 patients were randomized to receive either PCI with distal protection (n=65) or PCI alone (n=61). Fifty five patients per each group received post-PCI CMR. Forty one patients underwent 6 month MRI in distal protection group and 43 patients, in conventional PCI group.
736337|NCT01383993||
736338|NCT01383954||
736339|NCT01383928|Participants took part in the study at 15 investigative sites in the United States from 31 October 2011 to 27 November 2017 when the sponsor closed the study.|Participants with newly diagnosed multiple myeloma were enrolled in 1 of the 2 dose escalation treatment arms in Phase 1: ixazomib 3 mg and 3.7 mg induction followed by maintenance. Phase 2 consisted of ixazomib 3 mg during induction followed by maintenance.
736340|NCT01383759||
736341|NCT01383720|Patients were identified by their physicians as meeting the study inclusion/exclusion criteria.|Screening materials from patients identified by the investigators as having met the inclusion and exclusion criteria were reviewed by a Case Review Committee to assess and confirm eligibility.
736342|NCT01383707||
736343|NCT01383681||This was a retrospective chart review in patients with spasticity in the Spanish population.
736344|NCT01383616||
736345|NCT01383499||
736346|NCT01383486||435 subjects were screened, 384 were qualified for participation, 259 subjects presented at pharmacy to begin enrollment procedures, 254 gave inform consent, 1 subject refused to give pregnancy test, so 253 subject received the investigational products.
736347|NCT01383447||
736348|NCT01383421||
736349|NCT01383356|18 subjects were enrolled in the original study (June 2011 to July 2011) and 40 in the add-on study (November 2011 to December 2011) which was an option provided by protocol to increase the subject number. As no significant STUDY and STUDY-by-TREATMENT effect was revealed in analysis of pooled data, final analysis was performed on pooled data.|This is a 2 period, 2 sequence, 2 treatment crossover. Subjects were randomized to one of the two sequences AB or BA. The duration of washout was at least 35 days between dosing.
736350|NCT01383317||
736351|NCT01383213|Feb. 2010-feb 2013 5 Italian High Dependence Units|Exclusion criteria
736352|NCT01383200|The recruitment period is now over. Eligible patients included healthy patients undergoing bilateral LASIK surgery.|
736353|NCT01383174|Participants were recruited from February 2011 through November 2013 via flyers and word of mouth at clinics in five Northern California counties by community recruiters.|
736354|NCT01383161||
736355|NCT01383096|The first subject was randomised on 19-Apr-12; The last subject last visit was on 04-Aug-12. Subjects were recruited at the study site, Nucleus Network.|There was no wash-out, run-in or transition period between enrolment and group assignment.
736356|NCT01383018||
736357|NCT01383005||97 participants were enrolled; 3 participants who did not meet the inclusion criteria for treatment duration were excluded.
736358|NCT01382940||
736359|NCT01382901|Study Period: March 23, 2006 to July 16, 2007 Locations: Hospitals and Medical Clinics (15 total sites)|
736360|NCT01382719|A total of 1142 subjects were screened at 69 medical sites in the US and Canada, 612 subjects were enrolled, and 488 subjects entered the single-blind placebo treatment period; 397 were randomized, and 394 were dosed with randomized treatment.|A total of 91 subjects were not randomized due to failing the resting blood pressure criteria (36), withdrawal of consent (24), being lost to follow-up (9), adverse events (5), non-compliance (5), and other reasons (12).
736361|NCT01382602|Subjects were screened and enrolled at 10 sites globally; 8 sites in Canada, 1 site in Germany, and 1 site in United Kingdom.|227 subjects consented to study participation and were screened for eligibility, of whom 150 subjects were enrolled (underwent biopsy procedure) and 143 subjects underwent at least 1 study treatment AMDC-USR (93 subjects) or placebo (50 subjects). Analysis population is based on 143 subjects that underwent at least 1 study treatment.
736362|NCT01382446|Patients were recruited upon arrival to the Intensive Care Unit, or after mechanical ventilation was initiated.|Patients were randomized into groups after enrollment.
736363|NCT01382303||
736506|NCT01372618||
736507|NCT01372605||
736508|NCT01372501||
736365|NCT01382225|Subjects were recruited from 56 investigative sites in the United States.|Of the 1936 subjects enrolled, 268 did not qualify for vehicle run-in and were exited as screen failures. Of the 1668 subjects receiving vehicle run-in, 214 did not qualify for randomization and were exited as screen failures. This reporting group includes the 1454 subjects randomized to receive treatment at Baseline Visit (Day 0).
736366|NCT01382212||A total of 26 subjects were screened and 13 pediatric subjects (between 10 and 16 years of age) were enrolled; 1 subject was 16 years of age at the time of Screening and turned 17 by the time treatment began.
736367|NCT01382186||
736368|NCT01382108|39 non-contact lens wearers were recruited using CCLR records|
736369|NCT01381952|The enrollment of patients occurred between 22 June 2011 and 11 August 2011|20 patients enrolled the study; 16 patients were undergoing diagnostic neuroangiography and 4 were undergoing INR procedures for different pathological conditions. All signed patient consent.
736370|NCT01381926|Protocol open to accrual: February 2011, primary completion date, August 2015 and study completion date August 2015. Recruitment location at UAB. Postmenopausal women with diabetes mellitus on no medications or metformin alone were recruited from a single outpatient clinic setting.|Potential participants attended a screening visit to ensure they met inclusion/exclusion criteria. If they were on metformin at the screening visit, it was discontinued. They returned in 1 month for the baseline visit and randomization.
736371|NCT01381900|This study evaluated the efficacy and safety of canagliflozin in Asian participants with type 2 diabetes mellitus who had inadequate glycemic control on a maximally effective or tolerated dose of metformin alone or metformin plus sulphonylurea (SU). It was conducted between 30 June 2011 and 21 December 2012 and recruited patients from 36 sites.|The study had two background treatment strata: 331 participants in the metformin alone stratum and 347 in the metformin plus SU. In total, 678 participants were randomly allocated to the 3 treatment arms, 676 received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and the safety analysis set.
736372|NCT01381874||
736373|NCT01381861|Patients were screened and enrolled at 7 US sites|
736374|NCT01381679||
736375|NCT01381575|This study was conducted by 33 principal investigators in five countries (Canada, Germany, Italy, Taiwan and Thailand).|All 1447 subjects enrolled in the study were vaccinated and included in the Total vaccinated cohort (TVC).
736376|NCT01381562|The study was conducted at five centers in four countries (United Stated of America, Spain, France and Russia) between 03-October-2011 and 05-March-2012.|A total of 15 participants were enrolled in the study; of those, 5 participants each were randomised to receive GSK2251052, 750 milligram (mg) or 1500 mg or meropenem 1.0 gram (g), intravenously. One participant in the GSK2251052 1500 mg group was randomised but not treated, thus safety and efficacy populations consisted of 14 participants.
736377|NCT01381549|This study was conducted at eight centers in three countries (United States, Spain and Greece) from 28-June-2011 to 06-March-2012. A total of 20 participants were randomized in the study.|It was planned to enroll approximately 210 male and female participants with lower complicated urinary tract infection (cUTI) or pyelonephritis (complicated and uncomplicated); however, due to some unexpected microbiological findings, this study was terminated early with only 20 participants enrolled.
736378|NCT01381471||Participants were not recruited or enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and were used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
736379|NCT01381406|Participants were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.|Participants were treated with tiotropium bromide (TIO) or tiotropium bromide plus fluticasone propionate/salmeterol xinafoate combination (TIO + FSC) by their practitioners, and the database included information about their healthcare encounters.
736380|NCT01381120||
736381|NCT01381068||50 participants were randomized however one participants randomization assignment was undocumented, so 49 participants are accounted for.
736382|NCT01381016||
736383|NCT01380834||
736384|NCT01380782|Study activated at Dana-Farber Cancer Institute in May 2012 and was eventually activated at Massachusetts General Hospital, Cleveland Clinic, and University of Virginia. The bevacizumab-treated arm closed to accrual in December 2012 and the bevacizumab-naive arm closed in March 2013, both due to futility.|
736385|NCT01380769|The study was conducted from 04 Jul 2011 to 07 Oct 2014. A total of 24 medical clinics participated in the study.|
736386|NCT01380743||A total of 27 participants were enrolled; 25 participants completed the study. Two participants were discontinued from the study prior to assignment to a cohort: 1 participant voluntarily withdrew before receiving study drug; 1 participant was screened twice and enrolled once, and was counted twice under the total number enrolled.
736387|NCT01380730|"This study enrolled adults aged 18 - 80 years who were on a statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, and fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL.
~The first patient enrolled on 18 July 2011 and the last patient enrolled on 22 December 2011."|Eligible participants were randomized equally into 1 of 8 treatment groups. Randomization was stratified by screening LDL-C level (< 130 mg/dL or ≥ 130 mg/dL) and ezetimibe use at baseline (yes or no).
736388|NCT01380691||
736389|NCT01380639||Enrollment of patients is meant for the number of study completers without drop out patients (n=10).
736390|NCT01380535|Patients were enrolled in Austria, France, Germany, Italy, Hungary, Spain, the United Kingdom, and the United States. Enrollment started in November 2011, and the last patient visit occurred in March 2015.|All participants enrolled were included in the safety analysis set
736391|NCT01380379||
736392|NCT01380366||
736393|NCT01380327|Five NIAID ICAC sites in the United States recruited the targeted number of study participants who fulfilled entry criteria between May 2011 and February 2012. Of the ninety-nine subjects enrolled in the study, eighty-nine achieved the milestone of randomization and are included in the Participant Flow: Overall Study Results Section.|
736394|NCT01380197||
736395|NCT01380184|Fifteen (15) Chinese participants with treatment-refractory advanced or relapsed cancers were enrolled in this study.|
736396|NCT01380145||
736398|NCT01380080|Recruited at AIDS Clinical Trials Units in 10 international countries. Recruitment occurred between October 31, 2011 (date of first participant was randomized) and June 9, 2014 (date of last participant was randomized).|851 were randomized 1:1 to treatment strategies A and B. Results reported for 850 eligible participants; 1 was subsequently found ineligible and excluded from all analyses.
736399|NCT01379963||
736400|NCT01379937||The study was of an overall duration 364 days for all subjects.
736401|NCT01379924|The study was conducted in a teen-tot program (Young Parents Program) within a pediatric hospital. Eligibility criteria included maternal age <19 years at delivery and infant age <12 months old. At the first infant visit, every patient seen was asked to enroll in the study by trained program staff. assignment.|Of 152 eligible patients who received care in the Young Parents Program who were invited to participate in the randomized trial, 12 declined to participate and were never enrolled into the study, but continued to receive care in the program.
736402|NCT01379781|Recruitment took place between July 2011 and November 2013 at Columbia University Medical Center.|All enrolled participants were randomized.
736403|NCT01379768|Study participants were recruited from one study center located in Canada.|
736404|NCT01379703|The study was carried out in two parts. The first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation (Part I) and the second part (Part II) started in 2006 after the tablet formulation became available in participating countries.|
736405|NCT01379664||
736406|NCT01379651|26 children (14 boys, 12 girls; median age: 7 years 7 months; range 5-11 years), with severe IgE-mediated egg allergy (EA) were recruited from the Pediatric and Allergology Unit of the Fatebenefratelli Hospital in Benevento, Italy, from January 2008 to December 2009.|6 children(4 males and 2 females)were excluded from the study: one child because the parents had a history of unreliable management of complications and treatments;2 children because of poorly controlled asthma;3 children because of a positive double-blind placebo-controlled food challenge (DBPCFC) at a dose of raw egg emulsion higher than 0.9 ml.
736407|NCT01379625||
736408|NCT01379573||
736409|NCT01379534|Participants were treated with TKI258 until disease progression, unacceptable toxicity, death or discontinuation due to any other reason. All participants were followed for at least 30 days after their last dose of study drug for safety assessment.|If a participant didn't discontinue study drug due to disease progression, death, lost to follow-up or withdrawn consent to post treatment tumor assessment, then tumor assessments continued every 6 weeks until the start of new anti-cancer therapy, disease progression, death, lost to follow-up or withdrawn consent to tumor status follow-up.
736410|NCT01379521|Of the 65 patients who were screened they reflect the actual enrolment but 59 patients were randomized and were included in the FAS, the Safety Set and the PP Set. There were no exclusions. Post-Treatment evaluations included any patients that was treated and does not reflect the number completed in the Overall Study.|
736411|NCT01379508||
736412|NCT01379274|Recruitment from approximately 2010-2012.|
736413|NCT01379222||
736414|NCT01379183|Recruitment period: 07/09/2011 - 03/13/2013 Location: Mayo Clinic, Rochester, Minnesota|There was no wash out or run-in period following participant enrollment.
736415|NCT01378988||
736416|NCT01378975||
736417|NCT01378962||
736418|NCT01378520|June 2011 - January 2012; medical center|23 subjects recruited; 1 excluded (did not meet inclusion/exclusion criteria); 2 withdrawn prior to randomization (1 could not tolerate breathing through the initial inspiratory resistance (15 cm H 2 O/L/s); 1 gave ratings of breathlessness of < 50 mm on the VAS for the highest resistance (50 cm H2O/L/s))
736419|NCT01378429||
736420|NCT01378416||
736421|NCT01378377|First/last subject (informed consent): 27 May 2011/23 August 2012. Last subject completed: 23 February 2012; Subjects randomized at 2 centers in United States.|46 screened for eligibility; 13 were excluded (mainly non-fulfillment of inclusion or exclusion criteria). 33 subjects were enrolled and treated in the study.
736422|NCT01378325||
736423|NCT01378299||
736424|NCT01378273||
736425|NCT01378221||
736426|NCT01378195|Dates of recruitment period: May 2011 to March 2012|Participant assignment to group was random.
736427|NCT01378117|90 patients admitted to general medicine and surgery services in 2012 were enrolled in this pilot study. This study was conducted at Grady Memorial Hospital (Atlanta, GA), Emory University Hospital, and University of Michigan Health System.|Patients were included if they had Type 2 Diabetes with a BG 140-400 mg/dL and were treated at home with diet, oral antidiabetics, or low-dose insulin. 8 patients were excluded from further analysis because they received <24 h of insulin treatment, were transferred to the ICU, or received corticosteroid therapy.
736428|NCT01378104|enrollment date : 2009-2011 recruitment period : 2009-2012 type location: 14 university hospital|no excluded patients before assignment to groups
736429|NCT01378065||
736430|NCT01377987||
736431|NCT01377922|"The study was conducted at 13 clinical sites in 8 countries, including France, Germany, Hungary, Poland, Russia, Serbia, Spain, and the United States.
~The study was conducted from 03Jun2011 to 08Jul2016."|Open-label Run-in (Part 1): titration to the optimal amifampridine dose (well tolerated and resulted in a ≥3 point improvement in QMG score from Screening for patients without previous amifampridine use) for each individual patient. Patients who did not receive amifampridine prior to Run-in and who did not reach the optimal dose were discontinued.
736432|NCT01377636|During the preoperative evaluation for anesthesia, the patients scheduled for catheter ablation for atrial fibrillation were approached by the research associate for informed consent and enrollment into the study. The research consent was separate from the clinical anesthesia and procedural consents.|
736433|NCT01377623||
736434|NCT01377584||
736435|NCT01377480||A total of 393 participants were screened, 123 were eligible for enrollment, and 120 were randomized
736436|NCT01377467|Patients were recruited from June 20, 2011, to May 2, 2014. Patients were randomized after 15.7 ± 6.4 days after transplantation.|
736437|NCT01377441|Patients were recruited from the perioperative area.|
736438|NCT01377402||
736439|NCT01377389|All patients enrolled at MD Anderson Cancer Center between 2011-2013|All patients were screened according to inclusion and exclusion criteria as outlined per protocol.
736442|NCT01377012|At baseline, participants were randomized to 1 of 3 treatment groups. Placebo non- responders at week 16 were re-randomized to receive AIN457 75mg or AIN457 150mg. Placebo responders at Week16 were re-randomized to receive AIN457 75mg or AIN457 150mg at Week 24.|
736443|NCT01376908||"Out of 109 subjects screened for the study, 77 pharmacogenetics (PGx) informed consent forms were signed and 73 samples were analyzed which were used as analysis population for outcome measure 11 Number of samples with phenylalanine hydroxylase (PAH) gene mutations."
736444|NCT01376804||
736445|NCT01376700|Enrollment was conducted in Europe and North America at 19 clinical sites.|22 participants were enrolled. One was a screen failure; one did not have screening laboratory assessments performed prior to study termination; and one met screening criteria, but was not exposed to investigational product prior to study termination. Therefore 19 participants were treated
736446|NCT01376557||
736447|NCT01376388|131 participants (par.) comprised the All Subjects Enrolled Population (ASEP; all par. with records in the study database). One par. in the ASEP was withdrawn due to a Good Clinical Practice violation and was thus withdrawn from the Intent-to-Treat Population (comprised of all participants who received at least one dose of study drug; n=130).|Following screening and a 2-week Run-in Period, during which participants were evaluated for Baseline safety and chronic obstructive pulmonary disease (COPD) status, eligible participants entered a 52-week Treatment Period, followed by a Follow-up Period.
736448|NCT01376362||
736449|NCT01376349||A total of 464 patients were accrued to this trial. Nineteen patients withdrew consent prior to randomization and were not included in the analysis of this study. Two additional patients were unable to classify the primary symptom and were not randomized to the trial and were not included in the analysis.
736450|NCT01376323|This was a study in participants with Type 2 diabetes mellitus which was conducted across 14 centers in 4 countries (France [4], Spain [3], United Kingdom [4], Unites States [3]) from 13 July 2011 to 17 September 2012. Total of 89 participants were included in the pharmacokinetic population.|
736451|NCT01376310|159 subjects received treatment with GSK1120212 and were included in the safety set.|Continued treatment with GSK1120212 was provided for subjects who had previously participated in a GSK1120212 study and who continued to receive clinical benefit as well as have an acceptable safety profile with GSK1120212.
736452|NCT01376297||A total of 413 patients were randomized (ITT population), 412 patients received study drugs i.e.netupitant/palonosetron combination or aprepitant/palonosetron regimen, both with dexamethasone (safety population)
736453|NCT01376245||Eligible participants (par.) completed a 2-week Run-in Period for symptom scores at baseline and to establish a stable baseline. Par. were then randomized to a 24-week (wk) Treatment Period. 880 par. were screened, 744 entered the RIP and 646 par were randomized, out of which 643 par received >=1 study treatment dose.
736454|NCT01376167|This was a multi-centre, double-blind, randomized, parallel-group, active-controlled study to evaluate the efficacy, safety and tolerability of tafenoquine (TQ) in participants with Plasmodium vivax (P vivax) malaria. TAF112582 consisted of two parts-Part 1 (Phase 2 dose ranging) and Part 2 (Phase 3 pivotal). Results have been presented for Part 2.|A total of 683 participants were screened of which 161 failed screening and 522 participants were randomized to receive chloroquine (CQ) + 300 milligrams (mg) TQ, CQ + 15 mg primaquine (PQ) and CQ alone regimen in a ratio of 2:1:1.
736455|NCT01376089|A total of 304 subjects were enrolled in this study, however, 5 subjects did not receive contrast media due to administrative and /or technical reason leaving 299 subjects included in the analysis.|A total of 304 subjects were enrolled in this study, however, 5 subjects did not receive contrast media due to administrative and /or technical reason leaving 299 subjects included in the analysis.
736456|NCT01376050||
736457|NCT01376037|Sixty-two (62) subjects were recruited and enrolled between March 21, 2011 and November 28, 2011 at two separate clinical research centers.|There were no significant events or approaches for the overall study following participant enrollment, but prior to group assignment. There were no enrolled participants excluded from the trial before group assignment and no criteria for this possibility was included in the study design.
736458|NCT01375959||
736459|NCT01375946||
736460|NCT01375777|This study enrolled adults 18 - 75 years with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL, fasting triglycerides ≤ 400 mg/dL and a National Cholesterol Education Program Adult Treatment Panel III Framingham risk score of 10% or less. First patient enrolled 06 July 2011, last patient enrolled 25 November 2011.|Participants were randomized with equal allocation into 1 of 9 treatment groups. Randomization was stratified on the basis of screening LDL-C concentration (< 130 mg/dL [3.4 mmol/L] or ≥ 130 mg/dL).
736461|NCT01375764|"The study enrolled adults aged 18 to 75 years with hypercholesterolemia who were statin intolerant and with low-density lipoprotein cholesterol (LDL-C) levels above risk-based goals recommended by the National Cholesterol Education Program.
~The first patient enrolled on 28 July 2011; last patient enrolled 14 February 2012."|Randomization was stratified by screening LDL-C level (< 130 mg/dL [3.4 mmol/L] or ≥ 130 mg/dL) and statin use at baseline (yes or no).
736462|NCT01375751|"Men and women 18 to to 75 years of age, with a diagnosis of heterozygous familial hypercholesterolemia, fasting low-density lipoprotein cholesterol (LDL-C) of ≥ 100 mg/dL, and fasting triglycerides ≤ 400 mg/dL were eligible for this study.
~The first patient was enrolled on 02 August 2011 and the last patient was enrolled on 20 February 2012."|Randomization was stratified on the basis of screening LDL-C level (< 130 mg/dL [3.4 mmol/L] or ≥ 130 mg/dL) and ezetimibe use at baseline (yes or no).
736463|NCT01375673|98 subjects were screened. Of the 98, 15 were female, 21 meet both inclusion and exclusion criteria, and 16 began the enrollment process. Of those 16 subjects, 1 died prior to full consent, 1 choose not to enroll.|
736464|NCT01375660|Participants were recruited among African American Male veterans coming for medical care to Jesse Brown VA Medical Center in Chicago between May 2011 and December 2012.|
736465|NCT01375608||
736466|NCT01375569||
736467|NCT01375491|The study included non-type 2 diabetics controls (n = 15), and type two diabetics subjects randomized to placebo (n = 13) or doxycycline 100 mg twice daily (n = 11).|
736509|NCT01372462||
736602|NCT01367834|Subjects were recruited locally in the UNC_Chapel Hill pediatric endocrinology clinic and nationally through the Turner Syndrome Society, Turner Syndrome family internet groups, and advertisements on our UNC research website.|
736468|NCT01375374|The study was conducted at 5 sites across Austria (1 site), Germany (3 sites), and Spain (1 site).|The study consisted of a 1-week Screening Period, a 12-week Treatment Period (comprised of a 4-week Titration Period and an 8-week Maintenance Period), and a Taper/Safety Follow-Up Period 3 to 4 weeks in duration.
736469|NCT01375205||
736470|NCT01375140|Recruitment Period: September 2011- August 2013|
736471|NCT01375127|Participants who discontinued tofacitinib prior to the end of the planned treatment duration, or did not enroll in long-term extension studies after completing tofacitinib treatment in Phase 2a study A3921009 (NCT00106639) and Phase 2b study A3921030 (NCT00483756) were enrolled in this study.|
736472|NCT01375075||Prior to randomization, participants stopped lipid-related concomitant medications and started a diet therapy in accordance with the Japan Atherosclerosis Society guidelines for diagnosis and prevention of atherosclerotic cardiovascular disease.
736473|NCT01375049|Participants were enrolled at a total of 46 study sites in the United States and Europe. The first participant was screened on 04 October 2011. The last participant observation occurred on 29 May 2013.|109 participants were screened; 105 participants were enrolled and treated, and comprise the Safety Analysis Set and the Full Analysis Set.
736474|NCT01375010||
736475|NCT01374971||
736476|NCT01374919|Patients were recruited from routine referrals from obgyns, gastroenterologists, bariatric surgeons, general internists and nephrologists. All patients were iron deficient and anemic. All were oral iron intolerant. The data were presented at the 2012 American Society of Hematology meeting.|
736477|NCT01374906|At least 148 patients (Pts.) were planned & 150 were randomized & analyzed. Pts. were all treated with either pasireotide long-acting 10 mg or pasireotide long-acting 30 mg. 81 Pts. completed the Core phase & entered the Extension phase with 39 completing the Extension phase.|
736478|NCT01374802||
736479|NCT01374568|Postmenopausal women with diabetes mellitus on no medications or metformin treatment alone were recruited from an outpatient clinic setting.|Potential participants completed a screening visit to ensure all study inclusion criteria were met. If on metformin at the screening visit, the metformin was discontinued. Potential participants presented 1 month later for the baseline visit and for randomization.
736480|NCT01374516|Study participants were enrolled from 08 June 2011 to 16 March 2012 at 5 clinical centers in Brazil, 9 in Colombia, 1 in Honduras, 5 in Mexico, and 2 in Puerto Rico.|A total of 20869 participants were enrolled and randomized in the study.
736481|NCT01374490||
736482|NCT01374451||
736483|NCT01374438||
736484|NCT01374425||The trial included a 21-day Screening period during which participants provided information for demographics, medical history, and cancer/treatment history and completed urinalysis collection.
736485|NCT01374269|Patients (18 and 60 years) with SLBP (subacute low back pain) (lasting 4-12 weeks) with or without radiculopathy who were assigned to the social security system and living in the metropolitan area were included.|A specific cause for the pain (infection, tumor, ankylosing spondylitis, inflammatory conditions or cauda equine syndrome), the presence of red flags, scoliosis >15 °, depression or mental illness, history of gastrointestinal bleeding, renal failure, intake of anticoagulants or antiplatelet drugs and NSAID allergy were excluded.
736486|NCT01374217||One participant was a screen failure.
736487|NCT01374178||
736488|NCT01374087|Subjects with recurrence of prostate cancer previously treated with radiotherapy were recruited in 11 sites in Spain from November 2011 until December 2014 when the study was prematurely discontinued.|35 subjects were screened and 3 did not meet inclusion criteria. Of those who met the inclusion criteria and none of the exclusion criteria, 32 were randomised to treatment and 31 received treatment after 1 subject (in the Brachytherapy + Triptorelin arm) withdrew consent.
736489|NCT01373931||This was a randomized, 2-period, 2-sequence crossover study with a lead-in period.
736490|NCT01373918||41 subjects were enrolled in the study. Only subjects who required > 14 days of parenteral nutrition and who had an abdominal surgery were included in the final analysis.
736491|NCT01373671||
736492|NCT01373580||
736493|NCT01373489||
736494|NCT01373450||
736495|NCT01373346|If Patients were eligible for the study, each patient was informed of the investigational nature of the trial and received detailed information regarding the study protocol. All patients provided written informed consent before their enrollment. The enrollment continued from February 2010 through May 2011 in Gangnam Severance Hospital.|
736496|NCT01373294|Moffitt Cancer Center recruited participants between November 2011 and September 2014.|Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer.
736497|NCT01373281|Study participants were enrolled from 03 June 2011 to 01 December 2011 at 9 sites in Indonesia, 5 in Malaysia, 3 in Thailand, 5 in Philippines, and 2 in Vietnam.|A total of 10275 participants were enrolled; all but one met all of the inclusion criteria and none of the exclusion criteria. Three participants were not vaccinated and were excluded from the Full Analysis Set for Efficacy and the Safety Analysis Set.
736498|NCT01373242|Peanut allergic children ages 1-11 years|
736499|NCT01373229|Subjects were recruited from the CLL clinic at Duke Medical Center from January 2012 to December 2013.|21 subjects were consented to this study. Six (6) were screen failures; therefore, only 15 subjects began the treatment regimen which included a lenalidomide run-in phase. Three (3) subjects were unable to complete the run-in phase. Three (3) subjects died prior to completing stage 2, and so were not evaluable for DLT.
736500|NCT01373164||Completers included participants who died from any cause and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.
736501|NCT01372995|Study participants were recruited from critical care units at three hospitals in Atlanta, Georgia. 658 patients were assessed for eligibility, of these 562 did not meet inclusion and exclusion criteria. 65 eligible patients declined to participate while 31 gave informed consent and were randomized to one of the three study arms.|
736502|NCT01372878||
736503|NCT01372813|Trial only accrued 3 participants.|
736504|NCT01372774||
736505|NCT01372748||In this cluster randomized crossover trial, there are situations where age and gender are not known prior to the treatment being administered. These missing data account for the discrepancy between the enrollment number in the protocol section (23,711) and those in the participant flow module (23,687).
736510|NCT01372410||Participants were randomized to receive a sequence of 3 of 8 possible treatments over 3 treatment periods. There are 56 combinations of 3 treatments from the 8 study treatments, each of which can be ordered in 6 ways (totaling 336 possible sequences; 163 were randomly assigned). Participant Flow data are presented by treatment rather than sequence.
736511|NCT01372384||In all 145 participants were screened, of these 6 participants were randomized; major reason for screen failure was negative mutation status.
736512|NCT01372254||
736513|NCT01372202||
736514|NCT01372150||
736515|NCT01372085||Part A: single period, single dose pilot assessed safety, tolerability. Part B: 4-period crossover evaluated bioavailability of 2 drug formulations. Part B, Period (P) 4 participants (pts) separated into 2 cohorts, received drug under fed (P4a) or fasted (P4b) conditions. Pts who withdrew or were withdrawn prior to completing P3 were replaced.
736516|NCT01371994|The study population consisted of male patients > 18 years of age who were diagnosed with prostate cancer, treated by robotic assisted radical prostatectomy (RARP) and had urinary incontinence for 1 week following removal of the indwelling catheter.|Participants meeting the Baseline criteria were randomized 1:1 to 5 mg solifenacin succinate or matching placebo.
736517|NCT01371981||Results in the Participant Flow table summarize final (or analysis) arm assignment. Therefore, results for patients on Arms A, B, and D do not include any patient who transferred to Arm C.
736518|NCT01371877||
736519|NCT01371851||
736520|NCT01371838|The enrollment period was from 13 December 2011 to 26 April 2013|Enrolled patients (patients who gave informed consent) were screened for up to 24 hours to ensure eligibility before being randomized
736521|NCT01371825|A total of 8 centers participated in this study in the United Kingdom (UK), United States (US), France, Turkey, Ireland, and Egypt.|To assess eligibility, participants were screened for a period of up to 3 weeks prior to enrollment. 11 participants were screened, and 2 participants died during screening. The other 9 participants, all of whom were ≤8 months of age on the date of enrollment, met all eligibility criteria and were enrolled, treated, and analyzed.
736522|NCT01371786||
736523|NCT01371747|324 participants were enrolled in the study; 306 participants were randomized to receive study drug.|Screening serum potassium ≤ 5 mEq/L (milliequivalent) entered Run-in: Cohort 1 stopped ACEI/ARB (angiotensin-converting enzyme inhibitor/angiotensin receptor blockers), started losartan; Cohort 2 started spironolactone; Run-in (Cohorts 1 and 2) or screening (Cohort 3) > 5 mEq/L entered study.
736524|NCT01371734||
736525|NCT01371721|Participants who completed the 8-week, double-blind treatment phase of Desvenlafaxine Succinate Sustained Release (DVS SR B2061014 NCT01372150) and completed the 1-week transition phase (week 9) of the short-term study were eligible to participate in this study (DVS SR B2061031).|
736526|NCT01371708||A total of 304 participants completed study B2061032, 283 of whom were enrolled in the current extension study, B2061030, and 281 received treatment.
736527|NCT01371656||
736528|NCT01371643||
736529|NCT01371565|Eligible patients were men or non-pregnant women 18 yrs or older requiring medical treatment for symptoms of endogenous Cushing's syndrome due to ectopic ACTH, adrenal tumors/adrenal hyperplasia, or Cushing's disease if not candidates for pituitary surgery. Pts w/de novo Cushing's disease who were candidates for surgery were not enrolled.|All patients received active drug (no placebo).
736530|NCT01371552|Participants were recruited from 1 study center in Canada.|10 people were enrolled but not dispensed into Part 1 due to failing inclusion/exclusion criteria.
736531|NCT01371539|Participants were recruited and enrolled from 12 US private practices.|Five participants were enrolled, but not dispensed, due to failing inclusion/exclusion criteria (4) and unacceptable subjective vision (1). Baseline characteristics are presented on all enrolled and dispensed participants: 104.
736532|NCT01371305|The participants were enrolled across 10 sites in the US.|Forty-one participants were randomized and received at least one dose in the study.
736533|NCT01371110|Subjects were recruited from the Mood and Anxiety Disorders Program (MAPs). In addition, referrals from clinicians in the Mount Sinai Medical Center, community clinics, and affiliated hospitals were also sought.|Eligible participants met treatment-resistant criteria if they failed to respond to ≥ 2 adequate pharmacotherapy trials with SRIs FDA approved medications for OCD with or without adjunctive antipsychotics, as well as cognitive behavioral therapy.
736534|NCT01371006||
736535|NCT01370863||
736536|NCT01370837||
736537|NCT01370733|Enrollment occurred across 17 study sites (both academic and private clinical locations), initiated in May 2012 and all subject visits complete by July 2013. Three sites discontinued early due to departure of the Principal Investigator or due to a loss of contributing staff personnel. None were discontinued specifically due to a lack of enrollment.|Upon study closure, 291 subjects were consented for possible study participation with 202 of those subjects subsequently enrolled and randomized to treatment. Those entering the study at Screening while currently on an antidepressant required a minimum 1-week wash out period prior to completing a Baseline (Day 0) visit.
736538|NCT01370694|The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 on 18 March 2014, but could continue to receive maintenance therapy with rituximab per standard of care.|
736539|NCT01370655||Participants were randomly assigned to 1 of 12 treatment sequences Each 4-week treatment period was separated by a wash-out of approximately 4 weeks
736540|NCT01370642|Japanese patients 20-70 years old (inclusive) who had chronic, compensated, genotype 1 Hepatitis C (HCV) infection, and HCV ribonucleic acid (RNA) levels ≥ 5.0 log IU/mL peripheral blood at screening were recruited from 55 sites in Japan.|Of 294 randomized participants, 293 received at least 1 dose of study treatment and comprised the All Participants As Treated Population (APaT) as well as the Full Analysis Set (FAS). One treated participant was excluded from the FAS and APaT due to a protocol violation.
736541|NCT01370629||
736542|NCT01370616||
736543|NCT01370603||
736544|NCT01370590||
736545|NCT01370564||
736546|NCT01370538|From total of 526 screened subjects, 341 subjects were randomised. From 341 subjects 170 and 171 were allocated to Esomeprazole and Placebo respectively.|
736603|NCT01367704||
757779|NCT00201734|Patients were enrolled to the trial between July 2005 and November 2007|
736548|NCT01370499||This is an open-label study with 1 treatment (12 or 18 milligrams [mg] LY2216684 + SSRI). However, the data were analyzed by the participants' treatment group from 2 parent studies (Study LNBM: NCT01173601 or Study LNBQ: NCT01187407). In these prior, parent studies, participants were randomized to receive Placebo + SSRI or LY2216684 + SSRI.
736549|NCT01370460||We planned on 50 patients per treatment arm (100 patients total) and ended up with 101 patients total. We naturally wished to recruit more than the minimum to avoid the risk of jeopardizing statistical significance. There is no discrepancy that needs to be reconciled, except perhaps this explanation.
736550|NCT01370408||
736551|NCT01370369|The study was conducted at one study site in the US. Out of 42 subjects screened, 20 subjects were enrolled in the study.|Apart from having history of hypogonadism, the study subjects were required to present with one or more symptoms of low testosterone (i.e. fatigue, decreased muscle mass, reduced libido, reduced sexual functioning of a non-mechanical nature). The study subjects needed to be in good health despite exhibiting hypogonadism.
736552|NCT01370356|A total of 1747 participants were screened, whereof 1510 were randomized into the study, and of whom 1493 took at least 1 dose of study drug. Overall, 61 centers in 10 countries received study drug: Australia (4), Canada (6), Czech Republic (6), Germany (6), Egypt (3), United Kingdom (7), Japan (6), Mexico (4), Taiwan (7), and USA (12).|
736553|NCT01370317||
736554|NCT01370265|From June 30 to December 27, 2011 subjects were recruited at Mayo Clinic in Rochester, Minnesota.|
736555|NCT01370213||
736556|NCT01370083||
736557|NCT01370005||
736558|NCT01369888||Protocol was closed due to autoimmune toxicity unlikely related to cells and probably related to the IL-15 injection seen in one pt and also due to the opening of additional surgery branch protocols suggesting pt accrual would not increase in this protocol. The maximum tolerated dose (MTD) was not determined and it did not enter the phase 2 stage.
736559|NCT01369875||
736560|NCT01369849||
736561|NCT01369784|Recruitment was carried out between April 2009 and January 2011 in Hematology Departments of 56 Spanish Hospitals|
736562|NCT01369758||
736563|NCT01369745||A total of 294 subjects entered the titration phase. Of these, 258 subjects completed the titration phase, were randomized to treatment, received at least one dose of study drug and constitute the safety population. Of these, 252 subjects provided at least one post-baseline measurement of the primary endpoint and constitute the efficacy population.
736564|NCT01369732|This study was conducted at the university hospital between May 2011 and January 2013.|Six patients were dropped out regarding wrong dose-count of erythropoietin (n = 1), death within 24 hours after surgery (n = 2), and screening failure due to chronic kidney disease (n = 3).
736565|NCT01369706||
736566|NCT01369680|Recruitment began in June 2011 and closed in April 2012. Patients were referred by their primary pain physician.|
736567|NCT01369641||
736568|NCT01369615|First Patient First Visit: 05-January-2012; Last Patient Last Visit: 09-December-2013. The study was conducted at 14 medical/research sites in the United States and Israel.|Opioid-experienced pediatric patients with moderate to severe malignant and/or nonmalignant pain requiring around-the-clock opioid therapy were eligible for open-label Extension Study OTR3002 if they completed the 4-week treatment period Core Study OTR3001 and could benefit from continued treatment with oxycodone HCl CR 20 to 240 mg total daily.
736569|NCT01369511||
736570|NCT01369498|Participants were enrolled at study sites in the United States. The first participant was screened on 30 June 2011. The last study visit occurred on 24 September 2014.|62 participants were screened.
736571|NCT01369485||After informed consent was obtained, subjects had a 10-day washout period from any anti-cholinergic medications prescribed for treatment of overactive bladder prior to initiating study treatment.
736572|NCT01369433|Subjects who met all the inclusion and none of the exclusion criteria were enrolled in the study.|"All subjects underwent inclusion and exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures.
~All the study assessments were performed as per the schedule of assessment."
736573|NCT01369355|Out of 1282 participants enrolled,1 was excluded from study before assignment to arm/group due to deviation from Good Clinical Practice at 1 study site. Hence 1281 participants were analyzed. Total 397 participants who were in clinical response to ustekinumab induction were randomized in maintenance study and considered as primary population.|Due to a stability issue with the batch of Intravenous (IV) drug (130 mg ustekinumab), in November 2011 sponsor temporarily suspended dosing in induction studies (CRD3001 and CRD3002) and this maintenance study (CRD3003). All 3 studies were restarted with a 90 milligram per milliliter (mg/mL) formulation for IV administration on 17 February 2012.
736574|NCT01369342|A total of 640 participants were randomly assigned to receive study agent. The analyses (efficacy) were based on the 628 participants who were randomized after the study was restarted. However, one additional participant was excluded from efficacy analyses due to misconduct by the investigative site.|In November 2011, due to stability issue with the batch of the IV drug (130 mg Ustekinumab) sponsor temporarily suspended dosing of participants with ustekinumab. Study was restarted with 90 mg/ml on 17 February 2012.
736575|NCT01369329|A total of 769 participants were randomly assigned to receive study agent. The analyses (efficacy) was based on the 741 participants who were randomized after the study was restarted.|In November 2011, due to stability issue with the batch of the intravenous (IV) drug (130 mg Ustekinumab) sponsor temporarily suspended dosing of participants with ustekinumab. Later study was restarted with 90 milligram per milliliter (mg/ml).
736576|NCT01369225|This study enrolled participants who completed the first-in-human (FIH) study, B2601001.|
736577|NCT01369199|Twenty-eight (28) adults were enrolled at 11 clinical sites in the United States and Canada between 12/18/12 and 04/29/15.|
736578|NCT01369108||
736579|NCT01369069|Between April 2012 and August 2018, a total of 70 United States sites were included in the trial, and 63 sites enrolled at least one patient.|28977 patients were excluded after screening. Of those, 27344 did not meet eligibility criteria; 1156 were unable to provide informed consent or refused participation; 342 had other reasons and 135 did not specify a reason.
736680|NCT01363050|January 9, 2006 - February 27, 2006; Clinical Unit|After subjects had given their informed consent, subjects were required to pass a screening visit within 3 weeks prior to study drug administration.
736580|NCT01369030|Between November 2010 and January 2012, patients of at least 18 years of age who had been prescribed Deplin® by their physician for the treatment of major depression were offered to participate in the study by their prescibing physician, consisting of about 550 participating physicians located at various clinical sites country-wide.|Participants may have excluded themselves from the overall study after self-enrolling in the program if they did not complete the designated surveys prior to using Deplin® (Baseline) or at the 90-day time point post-treatment initiation.
736581|NCT01368965|Subjects desiring lift/tightening of cheek tissue, or improved jawline definition and/or submental skin laxity, and were Fitzpatrick skin types 3-6 were recruited. Fifty-four subjects were enrolled at two facilities. Study recruitment initiated 2/16/11; follow-up concluded 1/18/12.|Fifty-four subjects who met study eligibility requirements were assigned a study subject ID. Two subjects withdrew from the study due prior to study treatment. Data from these subjects are not included in the demographic summaries or in the efficacy analyses. Fifty-two subjects received study treatment.
736582|NCT01368900|Sixty-eight subjects were enrolled at two aesthetic medical facilities. Study recruitment was initiated on March 3, 2011, and concluded on July 13, 2011. Forty-five subjects were enrolled at one study site; 23 subjects were enrolled at the second study site.|Subjects presenting with rhytids and skin laxity in the periorbital region, Fitzpatrick Wrinkle Classification Scale (FWCS)of 3 to 7, qualified for study participation. Note: A protocol amendment restricting enrollment to FWCS scores of 3-7 occurred after 19 subjects with FWCS = 2 had been enrolled.
736583|NCT01368874|The study was conducted at two private medical clinics. Seventy-one 71 subjects enrolled, of which 64 subjects received study treatment February and July of 2011.|Seven enrolled subjects did not receive a complete study treatment. Six subjects were deemed screen failures, and one subject withdrew consent after receiving only a partial treatment. Sixty-four 64)subjects were assigned in a non-randomized fashion to each treatment group at the discretion of the PI.
736584|NCT01368835|Recruitment from June 30, 2010 to August 31, 2010.|Male or Female, aged 30 to 60 years. Desire to lift and tighten cheek tissue, improve jawline definition and/or submental skin laxity.
736585|NCT01368809|Prior to the day of surgery, potential study patients scheduled to undergo superficial surgical procedures received a packet of materials from their surgeon. The packet contained an initial patient contact letter, a privacy information sheet, and the institution review board (IRB)-approved informed consent form.|
736586|NCT01368653|Recruitment occurred between June 12, 2012 and May 24, 2013 through community-wide recruitment including direct mail, flyers, and radio advertising.|Randomization was in 2 phases; 1: participants who met inclusion/exclusion criteria were randomized to either standard treatment or standard treatment plus practice quitting; in phase 2, smokers who smoked between weeks 3 and 4 post-quit were randomly assigned to either receive advice only, or advice plus very low nicotine cigarettes.
736587|NCT01368614||
736588|NCT01368562||
736589|NCT01368536||Of the 975 patients screened, 417 were randomized.
736590|NCT01368497|Sixty children were enrolled at 7 pediatric clinical sites in the United States and Canada between 9/20/2012 and 12/30/2014.|
736591|NCT01368432|Subjects were recruited from the Brain injury clinic at Johns Hopkins Bayview Medical Center, other Johns Hopkins outpatient clinics, and via advertisements in local papers.|One admitted to active alcohol abuse before initiating medications , and therefore no longer met inclusion criteria. Another consented but failed to return for any follow-up visits.
736592|NCT01368406|Patients were drawn from: a) the Schizophrenia Program- Universidade Federal de São Paulo); b) the Schizophrenia Program of Institute of Psychiatry PROJESQ (Universidade de São Paulo); c) the CAISM (Centro de Atenção Integrada à Saúde Mental) from Irmandade Santa Casa de São Paulo; and d) the Community Psychosocial Center Luiz da Rocha Cerqueira.|
736593|NCT01368276|This extension was available to patients who participated in study 005/05 (NCT00769704), received the maximum allowable number of treatments or developed new lesion(s) within ≤ 12 months from the end of treatment visit after previous resolution of all disease while on study 005/05, and warranted further treatment per the investigator.|Participants received the same treatment as randomized under the 005/05 study.
736594|NCT01368263|The study opened to participant accrual on 09/13/2011 and closed to participant accrual on 05/22/2013.|
736595|NCT01368211||16 patients enrolled versus 15 patients started: One patient was enrolled by error (exclusion criteria) and excluded after randomization.
736596|NCT01368185|All the medical charts of the eligible study patients were reviewed. The study index period (when patients had to have received treatment for 3 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively between November 2008 and August 2010.|1735 patients were enrolled into this study. Among them, 1705 patients were eligible after excluding 30 patients.
736597|NCT01368081||
736598|NCT01368042||Of the 265 participants enrolled, 11 participants were considered to have protocol deviations and were excluded from the enrolled population and from all study-related analyses. A total of 254 participants were included in all of the study analyses.
736599|NCT01367886|Subjects with overactive bladder were recruited from principal investigator's clinic practice.|"Overactive bladder subjects completed a 3-day bladder diary and the Overactive Bladder questionnaire (OAB-q) prior to starting Toviaz (Fesoterodine) 4 mg daily. Another 3-day bladder diary and Overactive Bladder questionnaire (OAB-q) was completed by each subject at the end of a 6-week treatment with Toviaz.
~No washout period."
736600|NCT01367860|Patients referred to our tertiary hospital for lumbar back pain were recruited. They were included in the study if they had disc protrusion or small herniation in only one level, with magnetic resonance imaging findings compatible with symptoms, without neurological deficits, and with no resolution after six weeks of conservative treatment.|Exclusion criteria were: neurological changes during conservative treatment, pregnancy, clinical status not adequate for surgical procedures, non-adherence to informed consent form. After inclusion in the study, patients were evaluated for pain and function and then randomly allocated in two groups
736601|NCT01367847||Children are participants (i.e., N = # children); however, parents participate with young children in BPT (i.e., reference to parent-child dyads throughout). 22 parent-child dyads enrolled, 3 assigned as practice cases, given the pilot nature of the study (i.e., 19 for analyses), & 4 drop-outs, yielded N = 15 for analysis.
736746|NCT01358968||This was a nonrandomized, open-label, fixed-sequence, 2-period study followed by a continued access phase.
757896|NCT00190775||
736604|NCT01367665||A total of 1232 participants were enrolled in the study, but only 1215 received at least one dose of any study treatment. Results include only the treated 1215 participants. Not Done category includes participants who did not complete the final end of study completion CRF page, including those who withdrew due to termination of the study.
736605|NCT01367457||"A total of 243 participants were enrolled in the study, out of which 242 participants received treatment in reporting group RCC: Temsirolimus, MCL: Temsirolimus or MCL: Temsirolimus + Rituximab"
736606|NCT01367444|The Study was conducted in France and the United States. The trial was ended prematurely and the end of trial date declaration to health authorities was 16-August-2019.|A total of 35 participants who had Stargardt's Macular Degeneration (SMD) were screened, out of which 27 participants were enrolled in 7 cohorts (Cohorts 1 to 7).
736607|NCT01367275|Recruitment Period: August 16, 2011 to September 7, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Early termination due to drug sponsor decision to no longer develop drug. One participant was enrolled but not eligible therefore not treated.
736608|NCT01367262||Participants were considered to have completed the study at 9 days postdose or earlier if ≥90% of administered radioactivity recovered or 24-hour urine and fecal samples from 2 consecutive collections each had radioactivity levels <1.0% of total administered radioactivity in urine and feces combined.
736609|NCT01367249|This study was a multi-center, randomized, double-masked, parallel-group, placebo-controlled study, the first subject was enrolled 05/05/2011 and the last subject exited the study 07/29/2011.|440 subjects were enrolled from 39 clinical sites in the United States, of which 416 subjects received at least 1 dose of bromfenac or placebo.
736610|NCT01367236||
736611|NCT01367158||
736612|NCT01367119|Subjects were enrolled at Mayo Clinic, Rochester, Minnesota.|
736613|NCT01367080|Participants recruited from a specialty clinic at a hospital, Korea between July 2011 and August 2011|15 participants recruited ; 12 screened, 3 excluded (2 did not meet inclusion criteria and 1 refused participation)
736614|NCT01366976|Patients were enrolled by the research nurse at the time of the preoperative evaluation for surgery. The study period was from January 2012 until April 2013.|Patients were excluded for the following reasons: 1) allergy to acetaminophen, 2) evidence of severe hepatic impairment (history of liver cirrhosis or total bilirubin >2.0mg/dL) 3) evidence of impaired renal function (serum creatinine >2.0mg/dL) or 4) pregnancy.
736615|NCT01366885||
736616|NCT01366872|Orthopaedic clinical, Agility LP TAA|Minimum of 2 years post index procedure
736617|NCT01366846|From among those who completed the LEAP study (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), 556 subjects were recruited between 26 May 2011 and 6 June 2014 at Evelina Children's Hospital in London, UK.|In the LEAP trial, participants were stratified into strata based on a peanut allergen skin prick test (SPT). Participants were either SPT negative (0mm wheal) or SPT positive (1-4 mm wheal). Participants were then randomized into treatment groups within each stratum. This configuration was preserved in LEAP-On (this trial)
736618|NCT01366638|The study was conducted between 01-Apr-2011 to 20-Nov-2012 and recruited participants with chronic Hepatitis C Virus (HCV) infection from 14 study centers in Japan. A total of 79 participants with chronic genotype 1 HCV infection were randomized and started treatment; 65 completed the study.|Participants with genotype 1 hepatitis C virus (HCV) infection who were treatment-naïve or treatment-experienced (prior relapsers or nonresponders to interferon-based therapy) were assigned to 1 of 3 groups and received TMC435 100 mg/day for 12 weeks coadministered with PegIFNa-2b + ribavirin until Week 24 or Week 48.
736619|NCT01366534||
736620|NCT01366521|Participants (par.) were on a stable dose of their current asthma medications for 12 weeks prior to screening. Par. who met the eligibility criteria at screening were randomized to one of the four possible treatment arms. Total duration of participation in the study was up to approximately 22 weeks including screening, dosing and follow-up.|A total of 70 participants were enrolled into the study and 66 participants completed the study.
736621|NCT01366495||
736622|NCT01366443|Patients recruited from July 2010 to May 2011 at three Medical Hospitals, Departments of Obstetric and Gynecology Labor and Delivery Wards.|No particpants were excluded that matched the particpant enrollment of evaluation for suspicion of rupture of amniotic membranes by standard speculum examination for cervical leaking, pooling, ferning and nitrazine.
736623|NCT01366417|First subject/first visit: May 12, 2011 Last subject/last visit: June 8, 2011|43 subjects entered screening phase.25 subjects had qualifying treatment day baseline counts and completed the study.
736624|NCT01366209||
736625|NCT01366196||
736626|NCT01366092||
736627|NCT01365910|This study opened June 3, 2011 and continued until June 3, 2013. Patients were enrolled at Vanderbilt-Ingram Cancer Center.|Thirty-five patients consented to be on this study. Four patients were considered ineligible, and 1 patient withdrew prior to treatment.
736628|NCT01365845||
736629|NCT01365819||
736630|NCT01365793||
736631|NCT01365650|December 18, 2007 through February 15, 2008; Medical Clinic|After subjects had given their informed consent, subjects were required to pass a screening visit within 3 weeks prior to study drug administration.
736632|NCT01365624|February 2008 through April 2008; Clinical Unit|After subjects had given their informed consent, subjects were required to pass a screening visit within 3 weeks prior to study drug administration.
736633|NCT01365611|February 7, 2007 - May 22, 2007; Clinical Unit|
736634|NCT01365585||
736635|NCT01365546||
736636|NCT01365507|This trial was conducted at 38 sites in 6 countries: Malaysia, Mexico, South Korea, Thailand, Turkey and the United States (U.S.).|Subjects continued their metformin monotherapy or metformin in any combination with 1 or 2 additional oral antidiabetic drugs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV inhibitors, α-glucosidase inhibitors, thiazolidinediones, all with unchanged dosing for at least 12 weeks prior to randomisation.
736637|NCT01365494||
736679|NCT01363076|Recruitment Period: June 2007 - January 2008; Location: Stanford University Medical Center|Screening procedure consisting of an interview and the following assessments: demographics, medical history, physical examination, concomitant medications within last 30 days, vital signs, clinical laboratory tests, pregnancy test (female subjects).
736638|NCT01365481|A 1 arm study of valsartan but with 2 groups for analyses. The valsartan +antihypertensive group includes the patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.|These 2 groups were not randomized and considered to be 2 different populations since the patients in the valsartan+antihypertensive group had concomitant antihypertensive usage per individual patient's conditions at any time during treatment period.
736639|NCT01365468||
736640|NCT01365455|Not all patients that completed Maintenance Period continued in the follow-up Period. Many patients from Maintence rolled into CAIN457A2302E1 study|
736641|NCT01365273|Date of first patient included: 26 April 2011 Date of last patient completed: 01 December 2011|
736642|NCT01365130||
736643|NCT01365091||
736644|NCT01365052||
736645|NCT01365039|A total of 173 participants (346 eyes) were enrolled at 11 investigative sites in the United States (US), the first participant was enrolled in the study on 6/13/2011, the last participant exited the study on 10/1/2011.|This was a 3 month randomized, parallel, bilateral, single-masked study. One participant discontinued the study.
736646|NCT01364922||
736647|NCT01364896||
736648|NCT01364870||
736649|NCT01364740|Patients were recruited through the patient population at the Stanford Sleep Medicine Center|
736650|NCT01364727||"35 participants were fully screened for this study,and all 35 are included in Baseline Characteristics.
~However, 2 were ineligible and did not receive treatment, and so are not included in Outcomes nor Adverse Events."
736651|NCT01364649|Participants took part in the study at 57 sites in the US and 9 sites in Canada from 16 June 12011 to 9 December 2013.|Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 2 (flexible doses of either vortioxetine (Lu AA21004) 10/20 mg once daily (QD) or escitalopram 10/20 mg QD) treatment groups.
736652|NCT01364623||
736653|NCT01364584||
736654|NCT01364558||All 24 subjects were given each formulation with a two week wash out period.
736655|NCT01364467||
736656|NCT01364428|The trial was conducted at 44 sites within United States of America.|Subjects who were treated with basal insulin in combination with unchanged dosing of oral antidiabetic drug treatment (e.g. metformin, pioglitazone or DPP-IV inhibitor) in any approved dose or combination at unchanged dosing for at least 12 weeks prior to randomisation in a 1:1 manner to IDeg 200 U/mL or IDeg.
736657|NCT01364389||
736658|NCT01364298||
736659|NCT01364259|Patients will be evaluated by a multi-disciplinary team composed of radiation oncologists and neurosurgeons. During their visit, a physician or research coordinator will explain the study. Patients will be given the informed consent form to read. If they agree to participate, they will be asked to sign the consent form prior to participating.|Patient's pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed.
736660|NCT01364233||
736661|NCT01364207||
736662|NCT01364090||
736663|NCT01363999||
736664|NCT01363986||
736665|NCT01363908||The study consisted a pharmacokinetic (PK) phase and a chronic dosing (CD) phase. A sufficient number of participants were screened to enroll 16 participants into the PK phase (8 participants per age cohort). These participants could consent to participate in the CD phase. Additional participants also participated in the CD phase.
736666|NCT01363843|39 patients we enrolled, 36 completed all 8 cycles of induction modified FOLFOX6, 35 patients completed chemo-radiation, 38 patients underwent surgery.|
736667|NCT01363765|From Feb 4 to Oct 4 2012, all 11 primary care laboratories in Rio de Janeiro and 3 labs covering 70% of PTB diagnosis in Manaus participated. Over the same period, 4,660 patients were notified with PTB to SINAN (disease information database). Of these, 2,745 (59%) could be linked to test results in GAL (lab information system).|Samples (and not patients) were included if it was a first diagnostic sample in the intervention arm. Follow up (non diagnostic) samples were excluded for both arms, as were inadequate samples (insufficient material, blood stained-specimens) in the intervention group.
736668|NCT01363713||
736669|NCT01363700|"Period1 comparison with placebo (Epinastine vs Placebo)
~Period2 comparison with olopatadine (Epinastine vs Olopatadine)"|All participants completed Period 1 were randomized 1:1 to 2 groups in Period 2.
736670|NCT01363661||The drop-out rate post-PCI was high (>60%) mainly because the Endoscore was frequently above the pre-defined threshold post-PCI, attesting of the absence of endothelial dysfunction. Post-randomization drop-out rate was also high, 25% of patients being lost between randomization and month 12, mainly for non-serious adverse events.
736671|NCT01363492||
736672|NCT01363479||A total of 743 patients were randomized (ITT population), 739 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population), 738 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population) and chemotherapy (FAS population)
736673|NCT01363440|Participants with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye could participate in the study.|Of 687 participants who were screened for inclusion in the study, 466 were enrolled (started) and 461 received treatment.
736674|NCT01363401|Between March 2011 to May 2013, Of 10 subjects who consented to participate in the Stage 1 study, 2 subjects failed in screening, and 8 subjects were enrolled in the study. Among 71 subjects who consented to participate in the Stage 2 study, 7 subjects failed in screening, and 64 subjects were randomized.|Phase 1 : March 17, 2011 to November 24, 2011 Phase 2 : December 5, 2011 to May 6, 2013 The study consisted of stage 1 for safety evaluation and stage 2 for efficacy and safety evaluation of the study drug, and at stage 1, safety evaluation of the study drug, and at stage 1, safety evaluation for 28 days and then they followed stage 2.
736675|NCT01363388||
736676|NCT01363349||
736677|NCT01363297||
736678|NCT01363258|Recruitment occurred sequentially in 9 United States NHs.|Once potential participants were identified, we obtained consent from the legally authorized representative, screened them against inclusion/exclusion criteria, and then randomly assigned them to control or experimental groups.
736747|NCT01358877||The analysis included data up to a clinical data cut-off date of 19 December 2016.
736748|NCT01358864||
736681|NCT01363011|Participants were enrolled at a total of 40 study sites in Australia, Europe, and North America. The first participant was screened on 13 May 2011. The last study visit occurred on 16 February 2015.|177 participants were screened.
736682|NCT01362959||
736683|NCT01362946||
736684|NCT01362907|Participants were recruited from 4 US private practices.|
736685|NCT01362894|Participants were recruited and enrolled from 19 German study sites.|Two participants were enrolled, but not dispensed, due to unacceptable objective vision (1) and biomicroscopy findings (1). Baseline characteristics are presented on all enrolled and dispensed participants: 238.
736686|NCT01362790||55 participants were enrolled. No data was collected for 10/55 participants who were screened for neutralizing antibodies and were positive, thus not enrolled into a Group /Arm, nor treated. 45/55 participants were treated on this study.
736687|NCT01362686|Recruitment took place from 2011-2014. Recruitment took place in geriatric and memory care specialty clinics in an urban setting. Registered nurses, nurse practitioners, and research assistants completed the recruitment and informed consent procedures.|The enrollment goal in the original protocol of the study was 200 patient-caregiver dyads. 200 were enrolled, but it was discovered that 4 dyads were ineligible after enrollment and were not randomized or included in the study which brings the total enrollment to 196. Recruitment was then terminated due to low enrollment rate.
736688|NCT01362608||
736689|NCT01362530||The base study consisted of once cycle of treatment (Cycle 1). Participants in either treatment group who met the eligibility criteria were eligible to participate in optional open-label aprepitant treatment for an additional 5 cycles (Cycles 2-6).
736690|NCT01362517|Participants were recruited at one center in Vietnam First subject first visit (FSFV): April 2010 Last subject last visit (LSLV): April 2011|
736691|NCT01362491||
736692|NCT01362439||
736693|NCT01362348|This study was conducted at 10 sites in the United States, Germany and France from 7 July 2011 was early terminated on 22 Mar 2012 and completed on 16 April 2012. The study was terminated due to lack of efficacy.|
736694|NCT01362322||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
736695|NCT01362296|Participants who met eligibility criteria at Screening were then randomized to the treatment period. A total of 134 participants were randomized, and 130 participants entered the treatment period.|In the Randomized Phase (RP), participants were treated until disease progression (PD), death, or unacceptable adverse events were experienced. After PD in the RP, participants were given the option of crossing over to the alternative treatment arm in a Cross-over Phase (CP).
736696|NCT01362270||
736697|NCT01362244||At the end of a 10- to 14-day Run-in Period, participants (par.) were assessed for entry into the Treatment Period, comprised of 8 outpatient visits. For 6 of these visits, participants received a 4-weekly dose of either 750 milligrams (mg) mepolizumab or placebo. Four of the par. withdrew prior to 1st dose and are not included in the par. flow.
736698|NCT01362205||
736699|NCT01362192||
736700|NCT01362140|"This study was conducted at 49 centers in 9 countries. Participants were enrolled from 21 December 2011 to 06 January 2014.
~Results are reported for the double-blind treatment period of the study, with a 07 October 2015 data cut-off; the study is ongoing."|Eligible participants were randomized in a 2:1 ratio to receive darbepoetin alfa or placebo. Randomization was stratified by International Prognostic Scoring System (IPSS) category (low vs intermediate-1 risk) established at screening.
736701|NCT01362127||
736702|NCT01362062||
736703|NCT01362049||
736704|NCT01361919||some participants did not record some of the baseline data elements prior to being assigned
736705|NCT01361867|Healthy subjects were recruited by posting flyers in public areas and by contacting subjects who had previously expressed interest for volunteering in research studies in our laboratory.|
736706|NCT01361854||
736707|NCT01361633|"Inclusion criteria:
~age 60+
~fluent in English
~Exclusion criteria:
~current psychiatric disorder other than GAD
~substance abuse w/in past 3 months
~MMSE score of <24
~neurological disorder
~poor health or unstable medical condition
~positive tox screen tests
~current use of Isoniazid or Trecator
~renal insufficiency"|Participants were excluded at Baseline if they had abnormal lab results (6), were taking Aricept (1), were too worried about taking medication (1), or had concurrent depression (1).
736708|NCT01361620|Subjects were recruited from patients of the GWU Medical Faculty Associates, and physicians, faculty and staff on the GWU campus. Initially we were looking for those already prescribed to take aspirin at 81 mg daily, but due to slow recruitment, this was amended to anyone willing to take aspirin at 81 mg daily for 7-10 days|Excluded were 58 subjects prescribed more than 81 mg of aspirin, had known GI bleeding attributed to aspirin, active peptic ulcer disease, aspirin allergy, current use of other anti-platelet, anti-thrombotic or other therapy that has these properties, women who are pregnant, planning pregnancy or nursing. Exclusions were for safety reasons.
736709|NCT01361607||Per the Statistical Analyses Plan, all randomized participants who received at least 1 dose of study drug were analyzed in the Intent to Treat (ITT) population as per randomized treatment group. However, if a participant randomized to placebo ever took a nabiximols dose, the participant was analyzed as nabiximols-treated in the Safety population.
736710|NCT01361594|Emory University Hospital, Emory University Hospital - Midtown and Grady Hospital|Patients undergoing coronary artery bypass surgery (CABG) that develop hyperglycemia (defined as a blood glucose >140) intraoperatively or in an intenstive care unit (ICU) post-surgical procedure. 33 patients withdrawn prior to randomization, due to various reasons, including surgery cancellation, transportation to a different hospital, etc.
736711|NCT01361568||
736712|NCT01361464|The Southeast Phase II Consortium (SEP2C) enrolled participants at 3 cancer centers in the United States. The study opened to accrual on 5/24/2011 and closed to accrual 07/25/2012. Further development of Tipifarnib in acute myeloid leukemia (AML) was terminated after the study failed to meet the primary endpoint.|
736713|NCT01361308||
736714|NCT01361217||
736715|NCT01361178||
736749|NCT01358825||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
736716|NCT01361126||A total of 17 subjects were screened and enrolled in the study. Fifteen subjects participated in the pharmacokinetic (PK) evaluation period and were administered a dose of 25 IU/kg rIX-FP. Two subjects did not participate in the PK evaluation period because PK data for these 2 subjects were available from the previous phase 1 study (CSL654_2001).
736717|NCT01361113||28 patients consented to participate in this study; 6 patients were found ineligible and 1 patient refused treatment leaving 21 patients on study.
736718|NCT01361048||
736719|NCT01361009||
736720|NCT01360996|This clinical trial was conducted from January 2012 to December 2014 Healthy, premenopausal women (n=64) with polycystic ovary syndrome (PCOS), aged between 16 and 35 years inclusive with a baseline body mass index (BMI) of >18 to <35kg/ m2, recruited from Woman's Metabolic Health clinic and Woman's Hospital gynecology clinics were enrolled|Diabetic subjects, smokers, injectable hormonal contraceptive use within 6 months, or those taking sex hormones, carbohydrate metabolism, lipid-lowering and/or anti-obesity drugs within 3 months of the study were excluded
736721|NCT01360866|This trial was conducted in 2944 participants at 188 sites in 11 countries: Canada, France, Germany, Hungary, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, and United States (US).|The study population consisted of eligible participants who completed one of the double-blind, phase 3 brexpiprazole major depressive disorder (MDD) trials and who, could potentially benefit from adjunctive treatment with oral brexpiprazole for MDD.
736722|NCT01360840|First/Last subject (informed consent): April 2011/December 2012. Study completion date: July 2014. Clinical data cut-off: 30 April 2013. Subjects were recruited in 11 countries (Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Russia, South Africa, Spain, and USA) across the globe in 65 centers.|Enrolled: 283 screened for eligibility; 103 were excluded (mainly non-fulfillment of inclusion or exclusion criteria). 180 subjects were assigned to the treatment groups. Two subjects did not receive study drug administration.
736723|NCT01360762||
736724|NCT01360645|This trial was conducted in 826 subjects at 59 trial sites in the following 5 countries: United States, Canada, Poland, Slovakia, and France.|The study consisted of a 7 to 28-day Screening period, an 8-Week single-blind placebo + ADT prospective Phase-A, a 6-Week double-blind randomization Phase-B or single-blind Phase A+ and a Follow-up of 30 (+2) days after the last dose of study medication.
736725|NCT01360632|The study was conducted in 1539 participants at 92 trial sites in 7 countries. United States, Germany, Ukraine, Russia, Hungary, Canada, and Romania.|The study consisted of a 7 to 28-day Screening period, an 8-Week single-blind placebo + ADT prospective Phase-A, a 6-Week double-blind randomization Phase-B or single-blind Phase A+ and a Follow-up of 30 (+2) days after the last dose of study medication.
736726|NCT01360554|The study was conducted at 134 sites with 878 participants randomized in a 1:1 ratio to 1 of 2 treatment arms, of these 872 were treated. Eligible participants who provided written informed consent and met all inclusion and exclusion criteria were assigned a Single Subject Identification number and randomized by the central randomization system.|There were no significant study milestones following participant enrollment, but prior to group assignment.
736727|NCT01360450|"Infants recruited from the Neonatal Intensive Unit (NICU) and Pediatric Intensive Unit (PICU) at Johns Hopkins Hospital within 5 days of birth who needed sedation and analgesia as part of treatment.
~Recruitment period was from July 2011 to July 2014. Accrual was very low"|All patients who were enrolled participated in the study.
736728|NCT01360398||
736729|NCT01360229||
736730|NCT01360021||
736731|NCT01359956|Patients were randomly assigned to one of four treatment groups. Patients were randomized through a computerized procedure of permuted blocks centralized at the coordinating center (Medical Oncology, NCI Napoli), stratified by PS (0-1,2) and site of metastases (visceral, not visceral).|
736732|NCT01359943|Participants were randomized to one of the following 3 treatment groups in a 2:2:1 ratio: secukinumab 10 mg/kg i.v., secukinumab 150 mg s.c. or placebo.|
736733|NCT01359904|The recruitment occurred at 2 sites of McGill University Health Centre. The recruitment period was from June 1, 2011 to July 30, 2012.|"Once the treating physician identified the potential subject, the potential subject was approached by the research assistant with a consent form.
~All patients were consented by the research assistant through a written consent form. Then the subject was randomly assigned to the standard or higher glucose dialysate groups."
736734|NCT01359748|To recruit the volunteers, we have complied with the limb size distribution required on Standard Association for the American National Standards Institute(ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO 81060-2:2009 [5.1.4]|
736735|NCT01359735|Subjects were enrolled at a single US investigational site, between June 22, 2011and November 16, 2011|Subjects who met inclusion criteria returned for visit1 on the day of surgery and entered the study following. Subjects randomly assigned to HP802-247 or Bacitracin for post-surgical treatment, which lasted for up to 12 weeks or wound closure, which ever occurred first. Following completion of treatment subjects were followed for 4 weeks
736736|NCT01359644|The study was conducted at 18 centres in 2 countries.|A total of 350 participants were enrolled, and 211 were randomized and received study drug.
736737|NCT01359449|Study participants were enrolled from 19 May 2011 through 14 September 2011 in one clinic site in Canada.|A total of 123 participants that met the inclusion, but no exclusion criteria were enrolled and vaccinated.
736738|NCT01359410|The study opened to participant enrollment on 06/28/2007 and closed to participant enrollment on 10/28/2011.|112 participants were enrolled to the study but 12 participants (1 participant declined to be in the study and 11 participants were found to be ineligible) were excluded from the study before randomization to the arms.
736739|NCT01359371|Patients who were provided with the Tobacco Tactics manual as part of their inpatient hospitalization were automatically referred to the volunteer telephone cessation counseling program.|
736740|NCT01359254||
736741|NCT01359150||
736742|NCT01359111||
736743|NCT01359046||
736744|NCT01359007||
736745|NCT01358981||This is a 2-part (Part A and Part B) crossover study with four periods.In Part A, 8 participants were dosed at each dose level in 4 study periods (1 additional participant was dosed only in 1 study period). In Part B, a single cohort of 9 participants with type 2 diabetes mellitus (T2DM) participated in 3 dosing periods.
736873|NCT01350505||
736750|NCT01358760|A total of 897 subjects were screened at 42 medical/research sites located in the US (32 centers) and Canada (10 centers) and 450 subjects were randomized. The first subject first visit was on 21-JUN-2011 and the last subject last visit was on 12-APR-2012.|
736751|NCT01358734|Participants were randomized at 25 sites in North America (Canada and the United States).|Participants were centrally randomized 1:1:1 and stratified by the Eastern Cooperative Oncology Group (ECOG) performance score (0 to 1 versus 2) and peripheral blood blast count (<1 versus ≥ 1 x 10^9/L).
736752|NCT01358721||119 participants were enrolled, 92 participants were randomized of whom 1 was randomized but not treated. 27 participants did not enter treatment period due to: Participant withdrawal n = 1, Death n = 1, No longer meets criteria n = 22, Other reasons n = 3
736753|NCT01358708|First subject in: 22 June 2010; last subject out: 12 September 2011; ten (10) sites were recruited to participate in this trial and 7 of these (4 in France and 3 in Germany) enrolled subjects.|Inclusion criteria related to symptom severity and stool characteristics assessed during 2nd week of Run-In Phase; ≥ 5 days of symptom data necessary for randomization; Double-Blind Phase completers eligible for a 28-day open-label treatment with LACTEOL® if symptoms not improved or recurring within 1 month after end of blinded treatment.
736754|NCT01358578||
736755|NCT01358526|First subject first visit: 25-May-2011; Last subject last visit: 15-Oct-2012. The study was conducted at 132 medical/research sites in the United States.|Opioid-experienced subjects with moderate to severe pain due to chronic low back pain, who required around-the-clock opioid therapy.
736756|NCT01358357||"There were 2 phases in this study. In Phase 1 (Open-label Stabilization Phase), there was 1 reporting group. In phase 2 (Double-blind Maintenance Phase), there were 2 reporting groups.
~7 subjects completed the open-label but were not randomized DB(3- mood episode,3-not meeting the criteria for the DB phase,and 1-insufficient clinical response)"
736757|NCT01358331|25 participants were enrolled, received at least 1 dose of MK-8353 and were included in the analysis.|
736758|NCT01358266||Subjects who entered open-label period are defined as subjects who received at least one open-label injection during the open-label treatment period (Month 6 to Month 12, exclude Amendment 2 subjects), or those who had entered the open-label retreatment period (Month 12 to Month 24) with or without any PRN injections.
736759|NCT01358175||
736760|NCT01357980|Patients were recruited at 22 centres in six countries (Austria, the Czech Republic, Germany, France, Italy and Poland), including 17 centres in five countries (the Czech Republic, Germany, France, Italy and Poland) which enrolled patients.|"A screening visit was performed four to seven days prior to Baseline (Day -7 to Day -4).
~At Baseline, 47 subjects were randomised in a ratio of 5:2:5:2 to one of the four treatment groups."
736761|NCT01357915|Subjects from the GSK149203A S+ Group participated only in the Month 60 time point of the study.|
736762|NCT01357889|The enrollment number reflects the 283 participants starting the Multiple-dose Phase.|This study was comprised of a Screening Period (up to 2 weeks), a Run-in Period (4 weeks), a Treatment Period (TP: 17 weeks), and a Follow-up (8 weeks) Period. The TP had a Single-dose Phase (Bioequivalence [BE] Phase: 28 days) and a 12-week Multiple-dose Phase. In the BE Phase, 186 participants were randomized; 167 received >=1 treatment dose.
736763|NCT01357850||Participants (par.) who met eligibility criteria and completed a 30 day Screening were then randomized to a 13-week Treatment Period, followed by a Follow-up visit 28 days post-treatment. The duration of the study was approximately 20 weeks from Screening to Follow-up. A total of 100 par. were planned, and 82 par. were randomized.
736764|NCT01357720|"Participants were recruited at two vaccination sites in the Philippines:
~First subject first visit (FSFV): 30 May 2011 Last subject last visit (LSLV): 30 September 2011"|
736765|NCT01357655||70 participants were enrolled, 66 were treated. Reasons for non-treatment include 1 adverse event and 3 no longer met study criteria. Participants enrolled were only treated with Dasatinib. The Dasatinib + SMO antagonist (BMS-833923) arm did not have participants because the recommended phase 2 dose of the SMO antagonist had not been determined.
736766|NCT01357616|Subjects were recruited from 13 study centers located in China.|This reporting group includes all enrolled subjects.
736767|NCT01357577|Participants were recruited from three Veteran Affairs Medical Centers (VAMC): Syracuse, NY VAMC; Tampa Bay, FL VAMC; and White River Junction, VT VAMC. Participants were recruited from outpatient and inpatient clinics at the three respective facilities.|
736768|NCT01357564||
736769|NCT01357551|573 people were consented. Of those, 69 did not return to provide a weight at study entry. Of the 504 who provided a weight at study entry, 200 dropped out, 82 lost < 4 kg, and 222 lost at least 4 kg and thus were eligible for randomization in the maintenance phase.|
736770|NCT01357512||
736771|NCT01357356||
736772|NCT01357239||
736773|NCT01357161||Fifteen participants were enrolled in Part 1 and 121 participants were enrolled in Part 2 (n=136 total).
736774|NCT01357148|This was a postmarketing, safety study of participants with Type 2 diabetes mellitus prescribed sitagliptin phosphate/metformin HCL (JANUMET®) in clinical practices in the Philippines from January 2009 to May 2010.|
736775|NCT01357135|This was an observational, non-randomized, prospective, longitudinal study of participants with Type 2 diabetes mellitus treated in routine clinical practice by 1,569 primary care practitioners in metropolitan France. Study participants were enrolled from July 29, 2009 to December 31, 2010. The end of study follow-up was August 31, 2013.|
736776|NCT01356966|Subjects were recruited from the Atlanta Veterans Affairs (VA) Medical Center from August 2010 to May 2014.|42 subjects were withdrawn prior to group assignment. 16 were screen failures, 7 subjects withdrew, and 19 subjects were terminated early.
736777|NCT01356940||
736778|NCT01356667|The recruitment period lasted from Sept, 2011-August 2012 and took place at United American Indian Involvement, Inc.|No enrolled participants were excluded from the trial before assignment to groups.
736779|NCT01356628||
736780|NCT01356602||Number of subjects randomized was 397. Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to a safety set of 399 subjects. Subjects who did not receive study drug were excluded from analysis.
736781|NCT01356589||
737143|NCT01335542||One patient in the local infiltration group was deemed ineligible due to a rheumatoid arthritis. Only 90 patients were randomized to the study.
736782|NCT01356498|Subjects completing one of the randomized, controlled Phase 3 clinical trials (RCTs) of pegloticase [C0405 and C0406 (NCT00325195)] were invited to participate in this open-label extension study.|Participants made the decision, along with the treating investigator, of which dose to receive in this study while remaining blinded to treatment received and results during the RCT. Cohort designations are based on participants' initial RCT treatment and whether uric acid remained <6 mg/dL for 80% of the time during months 3 and 6 in the RCT.
736783|NCT01356407|325 subjects were screened and 300 subjects were randomized at 7 sites in China.|
736784|NCT01356277||1 patient withdrew after completing the enrollment visit, but before randomization.
736785|NCT01356147|Medstar Georgetown University Hospita NICU patients recruited from May 2012 to november 2014|No enrolled participants were excluded prior to assignment to groups
736786|NCT01355978||
736787|NCT01355796||
736788|NCT01355705||
736789|NCT01355679|This was an open label, multi-center prospective feasibility study in patients with refractory or recurrent neuroblastoma that enrolled at NMTRC centers across the country between 8/11/2011 and 11/26/2012.|
736790|NCT01355627|Participants took part in the study at thirty-five Centres in a total of 10 countries: Belgium, France, Germany, Greece, Italy The Netherlands, Poland, Russia, Spain and Sweden from 28 April 2011 to 27 June 2013.|Participants requiring dura sealing techniques for the prevention of post-operative cerebrospinal fluid (CSF) leaks were enrolled; 726 participants were randomized equally in 1 of 2 treatment groups, TachoSil® or Current practice group.
736791|NCT01355588|1 month and 2 weeks; Medeval Limited Skelton House, Manchester Science Park, Lloyd Street North, Manchester M15 6SH, U.K.|
736792|NCT01355575||
736793|NCT01355523|The recruitment period was from July 2011 till December 2012. The location was The Department of Breast Surgery - Herlev Hospital, Copenhagen - Denmark.|
736794|NCT01355497||
736795|NCT01355484||
736796|NCT01355471||
736797|NCT01355458||
736798|NCT01355419||
736799|NCT01355302||Subjects were to only participate in either the Phase 1b or Phase 2 portion of the study.
736800|NCT01355289||The Screening Period encompassed 14 days ±7 days. Prerandomization assessments took place in all participants who had provided informed consent.
736801|NCT01355224||
736802|NCT01355159|High risk pregnant women were recruited in Canada and internationally.|
736803|NCT01355081|Participants took part in the study at 32 investigative sites throughout Japan from 13 May 2011 to 21 December 2012.|Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 3 treatment groups: once a day 5 mg or 10 mg vortioxetine (Lu AA21004) or placebo.
736804|NCT01355068||
736805|NCT01354990|This was a postmarketing, safety study of participants with Type 2 diabetes mellitus prescribed sitagliptin phosphate (JUNUVIA®) in clinical practices in the Philippines.|
736806|NCT01354964||
736807|NCT01354951||
736808|NCT01354938||
736809|NCT01354899|The recruitment period was from 17 May 2011 - 29 June 2011. The study was conducted at four intensive care units in Sweden.|There was no wash-out or run-in phase included in the study.
736810|NCT01354691||
736811|NCT01354652||
736812|NCT01354496||
736813|NCT01354444||
736814|NCT01354431|Study is still on-going.|198 participants enrolled and 168 were randomized to study drug: 27 were not randomized to a study arm because they no longer met criteria and 3 were not randomized because the participants withdrew consent.
736815|NCT01354314||
736816|NCT01354223||Ninety-three subjects evaluated, 3 subjects found to be ineligible and not randomized or dispensed. 90 adapted single-vision contact lens wearers with myopia were randomized and dispensed on a 2 to 1 ratio within each site and across entire study. Subjects used that same assigned product throughout study duration
736817|NCT01354197||
736818|NCT01354145||
736819|NCT01354132|Participants were recruited at two sites, Lausanne University Hospital, Department of Psychiatry, Lausanne, Switzerland and at the Commonwealth Research Center of Beth Israel Deaconess Medical Center Boston, Massachusetts|320 signed consent 133 declined to participate 124 excluded - 65 by Physician decision, 59 subject withdrew 63 met all inclusion and no exclusion criteria 31 to NAC and 30 to placebo
736820|NCT01354106|recruitment started May 16, 2011 at cyberDERM|participant not to use any products on the test sites for 24 hours prior to the study state date.
736821|NCT01354028|Infants were recruited from the Neonatal Intensive Care Unit (NICU) at a Children's Hospital. Recruitment dates were 03/09/2011 to 05/09/2012. A total of 30 infants were enrolled.|Seven infants were enrolled but did not complete the study. Two infants developed medical complications before the study and therefore became ineligible. Four infants were discharged before the study began. One infant did not have a quiet alert state after feeding and the study was discontinued at that point with no data collected.
736822|NCT01354015|01/01/12 from diabetes clinic|
736823|NCT01353976||
736824|NCT01353963||
736825|NCT01353911||368 participants enrolled on study. 36 cirrhotic participants received open-label (OL) grazoprevir + peginterferon (Peg-IFN) + ribavirin (RBV), and 332 non-cirrhotic participants were randomized to receive 100, 200, 400, or 800 mg grazoprevir + Peg-IFN + RBV. 43 in the 400 mg group and 36 in the 800 mg group were down-dosed to 100 mg grazoprevir.
736826|NCT01353898|Two treatment groups planned for Part II (800 mg MK-1972 twice daily, and Placebo twice daily) were not enrolled, and are therefore not included in these Results.|
736827|NCT01353859||
736828|NCT01353703||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
736829|NCT01353664|This rollover study was designed to give access to Romidepsin (Romi) for participants in and then discontinued from Romi studies ROMI-ADVM-001 (NCT01324310) and ROMI-ADVM-002 (NCT01324323) who in the opinion of the investigator could have benefited from ongoing therapy with Romi; those from GPI-06-0002 did not rollover as the study did not close.|Participants started at any point during a cycle which corresponded to their previous Romi study, but continued cycle numbering where it left off from their previous participation in a Romi study
736830|NCT01353586|A total of 186 eligible subjects enrolled in this study across 8 sites in Europe. The first was enrolled on March 14, 2011 and was treated on March 15, 2011. The last was enrolled on October 16, 2012. The study's last 12 month follow-up visit occurred on September 27, 2013.|The Main Study consisted only of subjects treated with nMARQ ablation system, without a control arm. Later, a Subpopulation Neurological Assessment (SNA) was added to evaluate for potential cerebral micro-emboli and neurological deficits post ablation. The SNA included a comparator control arm of subjects treated with the Navistar® ThermoCool®.
736831|NCT01353508|In each of the HF and HTN cohorts, 16 participants (total = 32) received LCZ696 or Valsartan in period 1. Then, there was a cross-over where participants received LCZ96 or Valsartan in period 2.|
736832|NCT01353274||
736833|NCT01353222||
736834|NCT01353196||
736835|NCT01353144||
736836|NCT01353079||
736837|NCT01352845||A total of 3304 participants were randomized in this study, out of which 3293 participants received vaccination.
736838|NCT01352793||A total of 5712 participants in 12 countries were enrolled in this study. Of these, 8 participants were randomized but did not receive study vaccination.
736839|NCT01352741|The trial started on 23 Mar 2011 and the last participant completed the last follow-up examination on the 17 Jan 2012.|"622 participants signed an informed consent. All participants included in the 8 week Double Blind Comparative Period were initially in the open-label titration period.
~Participants in the open-label tapentadol continuation period were in the open-label titration period but did not enter the comparative period."
736840|NCT01352715|Recruited at international AIDS Clinical Trials Group Units. Recruitment occurred between March 13, 2012 (date first participant was randomized) and October 2, 2013 (date last participant was randomized).|515 were randomized 1:1 to treatment arms A and B.
736841|NCT01352637||"Total sample size is n=192. Randomization allocation ratio was 1:1:1:1 to VRE vs. PE and DCS vs. placebo.
~Study had 2 co-primary aims to examine:
~the effects of DCS (n=95) vs placebo (n=97) augmentation of exposure therapy
~the relative efficacy of VRE (n=97) and PE (n=95) on PTSD symptoms."
736842|NCT01352598||
736843|NCT01352585||
736844|NCT01352546||
736845|NCT01352507||
736846|NCT01352468||
736847|NCT01352442||
736848|NCT01352416|Recruitment started October 2010 and completed November 2012|
736849|NCT01352286||
736850|NCT01352221|Potential subjects were selected from the general population attending each centre in UK, DE, AT or HU for routine care of their IBD and anaemia. Individuals interested in participating were invited for the Screening visit in order to assess eligibility. Written informed consent was obtained prior to conducting any study specific assessments|Subjects were male or female ≥18y with a confirmed diagnosis of Crohn's Disease (CD) in remission or mild-to-moderate CD (defined as CD Activity Index [CDAI] score <220 at randomization); mild-to-moderate IDA (Hb concentration ≥9.5 g/dL and <12.0 g/dL for females; ≥9.5 g/dL and <13.0 g/dL for males; serum ferritin levels <30 μg/L at Screening.
736851|NCT01352182||
736852|NCT01352117|Participants were recruited from November 2011 to February 2016 at 10 sites in Africa and South America.|
736853|NCT01351766||
736854|NCT01351740||
736855|NCT01351623||
736856|NCT01351506||
736857|NCT01351480||
736858|NCT01351415|This phase 3b study was conducted across 16 different countries and enrolled 485 participants. Participants were 18 years or older and had locally recurrent or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC)|A total of 485 participants were enrolled and randomized into the study. Of these, 475 participants were treated; 243 participants received bevacizumab plus standard of care (SoC) and 232 participants received SoC alone. The study was terminated 60 months after study start, as per protocol, but was not ended prematurely.
736859|NCT01351376||
736860|NCT01351350|Participants took part in the study at three investigative sites in the United States from 28 February 2011 to 15 Sep 2017.|Participants with advanced solid malignancies enrolled in the dose escalation phase to establish MTD: MLN0128 6,7,8,9,10 mg QDx3d QW, 7mg QDx5d QW or 30, 40 mg QW. The expansion phase enrolled participants in either A: HER2- cancer participants, MLN0128 at MTD+paclitaxel or B: HER2+ cancer participants, MLN0128 at MTD+paclitaxel+trastuzumab.
736861|NCT01351337||
736862|NCT01351090|Recruitment period - October 2001 through August 2002 Locations - Hospitals|Subjects must have been requesting pain medication and have at lease moderate pain defined as a score of at least 40 mm on a 100-mm VAS.
736863|NCT01351077||
736864|NCT01351064||
736865|NCT01351025|A5275 opened under version 1.0 on April 7, 2011, and the first participant was randomized on April 14, 2011. Accrual to the study closed on May 31, 2013, with a total of 98 participants enrolled at 31 sites.|Four enrolled participants did not start study treatment (3 from arm A and 1 from arm B) due to enrollment error and noncompliance. These 4 participants were not included in the study efficacy or safety analyses.
736866|NCT01350999|Participants took part in the study at 50 investigative sites in Japan from 11 November 2009 to 11 January 2011.|Participants with hypertriglyceridemia were randomized to receive omega-3-acid ethyl esters 90 (TAK-085) 2 g once daily or TAK-085 2 g twice daily or EPA-E 0.6 g three-times daily.
736867|NCT01350973|Participants took part in the study at 69 investigational sites in Japan from 21 November 2009 to 28 December 2010.|Participants with hypertriglyceridemia were randomized to receive omega-3-acid ethyl esters 90 (TAK-085) 2 g once daily or TAK-085 2 g twice daily or EPA-E 0.6 g three-times daily.
736868|NCT01350947||
736869|NCT01350934||
736870|NCT01350804|At baseline, participants were randomized to 1 of 4 treatment groups. Placebo non-responders at week16 were re-randomized to receive AIN457 75mg or AIN457 150mg. Placebo responders at Week16 were re-randomized to receive AIN457 75mg or AIN457 150mg at Week24. Fifteen participants from the placebo group discontinued prior to re-randomization.|Abatacept responders at Week16 continued on abatacept and non-responders at Week 16 were re-randomized to begin either AIN457 75mg or AIN457 150mg at Week 24. Of the 551 core study participants, 254 participants entered the extension study.
736871|NCT01350583|This study was open to enrollment at Moffitt Cancer Center from August, 2010 through July, 2011. Two participants were actually enrolled during 2010.|
736872|NCT01350544||
736874|NCT01350492|Between May 2013 and March 2018, participants were recruited through digital and print advertisements in area medical centers, presentations at Veteran Service Organizations and via a mailed letter targeting Veterans from a VA database search. The first participant was enrolled in June 2013 and the last participant was enrolled in March 2018.|Following phone screening, 119 participants were invited to participate. Of those, 77 were enrolled and underwent a more substantial screening process. 54 participants were randomly assigned to a group. The remaining 23 participants were not assigned to a group as they were ineligible (n=17) or declined to continue (n=6).
736875|NCT01350479||Three participants withdrew from the study prior to cultures being obtained and were not assigned to a study group.
736876|NCT01350453||
736877|NCT01350414||
736878|NCT01350401||
736879|NCT01350388||
736880|NCT01350271|In order to identify those with hookworm infections, all individuals living in 219 households, in 8 estate divisions in Ratnapura District known to have a high prevalence of hookworm, were recruited to the study after obtaining their written, informed consent. Each person was requested to provide one faecal sample.|Infants below the age of 2 years, pregnant women, and those with diarrhoea on the day of recruitment were excluded from the study.
736881|NCT01350258||
736882|NCT01350245||
736883|NCT01350232||
736884|NCT01350141||
736885|NCT01350128|Conducted at 9 US sites from May-October 2011. Entire period of study participation per subject was a maximum of 15 weeks. Planned target enrollment of 84 subjects.|This was a chronic dosing study (7 days), 3-period, 6-treatment, incomplete block, crossover study. Each subject received 3 of 6 possible treatments; each treatment period was separated by a washout period 7-28 days. By-treatment sequence tabulations of the data were not pre-specified.
736886|NCT01350115||Participants were assigned to one of the following 2 treatment arms in a ratio of 6:1,LDE225 400 mg QD and Placebo QD.
736887|NCT01350102|Two subjects were screened and enrolled at the clinic site on 2/24/2012 and 1/14/2013.|
736888|NCT01349972||
736889|NCT01349959||58 consented, 18 screen failed and did not receive study treatment
736890|NCT01349933||
736891|NCT01349920|Participants 18 to 60 years of age, with moderate to severe Crohn's Disease (CD) who had not been previously treated with anti-inflammatory biologic agents were enrolled in this trial.|
736892|NCT01349907|Participants with a diagnosis of bipolar I disorder who completed the 3-week base trial P06107 (NCT01224485).|
736893|NCT01349829|Recruitment period: 25 March 2010 to 18 April 2011; outpatient study|
736894|NCT01349816|Conducted at 14 US sites from July-November 2011. Entire study period of study participation was a maximum of 9 weeks.|Study was a chronic dosing study; each participant received 2 of 6 possible treatments; each treatment period was separated by a washout period of at least 7 days. Patients were randomized into one of 30 treatment sequences. Each sequence included exactly 2 of the 6 treatment groups for this study.
736895|NCT01349803|Conducted at 15 sites throughout the US, Australia, and New Zealand from May 2011 - November 2011. Study participation was a maximum of 7 weeks.|Study was a multicenter, randomized, double-blind, parallel group, chronic dosing (14 days) study; each patient was randomized to receive 1 of 4 possible treatments over the course of a 14-day treatment period
736896|NCT01349790||
736897|NCT01349673||Each participant received study drug for 6 weeks per cycle for up to 8 cycles and underwent a 48-hour study drug washout period between each cycle. Study was terminated for non-safety reasons when Sponsor felt sufficient long-term safety data was obtained.
736898|NCT01349660|Between Oct 2011 and May 2012, 12 participants with refractory solid tumors were enrolled into the Phase I dose escalation trial from 3 U.S. investigational sites. Once a maximum tolerated dose was assigned, from Jul 2012 to Jun 2016, 76 patients with glioblastoma multiforme were enrolled in the Phase II trial from 7 U.S investigational sites|
736899|NCT01349595|Subjects were recruited from the Mayo Clinic transplant program in Rochester, Minnesota.|
736900|NCT01349569||Two participants were screen failures. One participant withdrew consent prior to starting the study.
736901|NCT01349491||
736902|NCT01349465||In total 250 participants were screened and among those 249 were enrolled into the study (200 participants with SVR and 49 participants with no SVR).
736903|NCT01349231||
736904|NCT01349192|The trial was conducted from April 1, 2011 to September 2014 at 14 CF Foundation accredited care centers in the United States.|
736905|NCT01349114||
736906|NCT01349049|A total of 90 participants (34 in Part 1 and 56 in part 2) were enrolled in the study and received PLX3397.|The study participants enrolled are patients with relapsed or refractory Flt3-ITD+ AML, or newly diagnosed Flt3-ITD + AML patients who either refused or were considered not to be appropriate candidates for chemotherapy.
736907|NCT01349036|A total of 38 participants who met all inclusion and none of the exclusion criteria were enrolled and received the study drug.|Enrollment planned to include approximately 40 participants (10 in Cohort 1 and 30 in Cohort 2) recruited from approximately 6 clinic sites.
736908|NCT01348854||
736909|NCT01348789|The recruitment was conducted in a medical clinic. The recruitment continued from January to June 2011.|
736910|NCT01348776|The recruitment was conducted in a medical clinic. The recruitment continued from April to October 2011.|3 subjects were found not eligible and 1 withdrew the informed consent before beginning treatments.
736911|NCT01348763||
736912|NCT01348698||
736913|NCT01348607||
736914|NCT01348542||
736915|NCT01348490|Participants took part in the study at 27 investigative sites in the United States from 15 June 2011 to 19 December 2018.|A total of 66 participants were enrolled in the study. Fifty-five participants completed 24 weeks of treatment (core treatment period), and 23 participants entered the extension phase.
736916|NCT01348425||
736917|NCT01348347|15 patients were treated and analysed.|This was an open-label, uncontrolled, dose escalation phase I study of once every three weeks intravenous treatment with BI 6727(volasertib) in Japanese patients with advanced solid tumours.
736918|NCT01348165||
736989|NCT01344161|In November 2009 we distributed advertisements in campus of Tehran University of Medical Sciences (TUMS) and invited all female students and employee to participate in our study.|
736919|NCT01348139|A total of 39 patients were enrolled at 3 centres in Sweden. Of these, 26 patients were randomised to receive a treatment sequence consisting of 6 different treatments in random order. The number of patients randomised was well balanced across all the treatment periods. In total, 25 patients completed the study.|
736920|NCT01348100||
736921|NCT01348087|The study was conducted at 28 centers in 10 countries|A total of 148 patients were enrolled and treated, including 1 patient who discontinued and was later re-enrolled under a new patient number. Category 1 patients received AFQ056 in the core study and enrolled in the extension within 7 days of completing the core study; Category 2 included all other patients enrolled into the extension study
736922|NCT01347931||
736923|NCT01347879|Dermatology clinics in the US.|
736924|NCT01347866||In Arms A and B, 7 and 14 participants were screed and received study treatment, respectively. In Arm C, 45 participants were screened and 44 received study treatment. In Arm D, 39 participants were screened and 37 received study treatment. There was no Stage 2 for Arm D, the study was terminated before enrolling patients to Stage 2 for Arm D.
736925|NCT01347840||
736926|NCT01347788||
736927|NCT01347762||14 potential subjects were screened but did not qualify for Phase 1 and 18 for Phase 2. Reasons included: positive urine screen for opiates or cocaine, lost to follow up after screening visit, withdrew from the study due to time constraints before randomization, met criteria for alcohol dependence or did not test positive for THC urine screen
736928|NCT01347710||
736929|NCT01347632|Recruitment for 6 months|
736930|NCT01347580|Patients were randomized in pre-hospital settings at 102 Emergency Medical Services between September 2011 and October 2013. 1875 patients were recruited in the study, 1862 consented patients were randomized.|
736931|NCT01347554|Between January 2009 and December 2010, we undertook a multicenter, prospective, randomized trial in 4 tertiary university hospitals.|Patients with acute myocardial infarction were eligible if they had at least one lesion with a diameter stenosis of 50%or more. Before randomization, 3 patients withdrew consent and 18 patients did not meet inclusion criteria among 500 patients.
736932|NCT01347333||
736933|NCT01347307||
736934|NCT01347255|First Subject First Visit: 12-MAY-2011 Last Subject Last Visit: 20-JUN-2011|"The study was conducted with 3 successive individual phases:
~Screening Phase (washout if applic.). A medical examination was performed at screening which took place 1-21 days before the start of the treatment phase (Day 1).
~Treatment Phase (All patients (N=24) received all investigational medicinal products)
~Follow-up Phase (if applic.)"
736935|NCT01347112||
736936|NCT01347086|60 subjects were included (27 Chinese, 25 Japanese, and 8 Caucasian subjects). 24 Japanese and 24 Chinese subjects were randomised to 1 of 3 (rising) dose groups and received single oral doses of either 400mg, 800mg, or 1200mg of BI 207127 NA or of the respective placebo. Caucasian subjects were randomised to 1200 mg BI 207127 NA or placebo.|The decision to proceed to the next higher dose group was based upon the safety of the preceding dose group. Caucasian subjects were randomised to receive either placebo or 1200 mg BI 207127 NA; this dose group could be started independently from the results of dose escalation in the Asian subjects.
736937|NCT01347073|"Study Locations: Houston, TX; Minneapolis, MN; Washington, DC; New York, NY; Cleveland, OH; Portland, ME; Portland, OR
~Study Initiation Date: September 9, 2011 Study Completion Date: April 4, 2013"|This is an open-label, fixed-sequence NaPBA to HPN-100 switchover study with no control group.
736938|NCT01347060||Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
736939|NCT01347034||
736940|NCT01347008|Patients recruited at the Outpatient Clinic of The Federal University of Sao Paulo, between August 2011 and November 2012|
736941|NCT01346852||
736942|NCT01346839||
736943|NCT01346774|Participants were recruited at their preoperative appointment for gynecological surgery. At enrollment they completed a questionnaire about their history and signed an informed consent form. Participants were not assigned to a treatment arm until the day of their surgery.|"If a participant's surgery was canceled or she failed to complete her enrollment questionnaire she was not assigned to a treatment arm.
~200 women were consented, 160 were randomly assigned to treatment (80 cranberry, 80 placebo)."
736944|NCT01346696||
736945|NCT01346683||
736946|NCT01346592|Participants were enrolled from 8 sites in Argentina, 5 sites in Australia, 2 sites in Chile, 12 sites in Philippines, and 5 sites in South Africa.|4 of the enrolled subjects were not randomized hence were not included in the trial.
736947|NCT01346540||Phase I was open-label, 3+3 dose-confirmation part of the trial aimed to confirm safety of nintedanib to a maximum dose of 200 milligram twice daily given in combination with the standard regimen of gemcitabine and cisplatin. Phase II was to be double-blind, randomised, placebo-controlled part, but this part of the trial was not conducted.
736948|NCT01346514|Participants (n=181) were recruited from the VA Puget Sound, Seattle Division between October 2011 and November 2015.|
736949|NCT01346501||
736950|NCT01346488|Data sources in this study are from medical charts. Investigators in this study transcribed a participant's data from medical charts to a case report form (CRF) developed by AbbVie.|A total of 2088 participants filled out registration forms. A total of 1973 participant CRFs were retrieved for use in the study, and 1968 of these were included in the analysis.
736951|NCT01346475|Participants recruited from October 2008 to April 2010. Participants recruited at the University of Washington Virology Research Clinic in Seattle, WA.|
736952|NCT01346410||
736953|NCT01346397||
736954|NCT01346371|"Recruitment began Aug 15, 2011 and concluded June 11, 2012. There are a variety of sources we recruited our subjects from which is outlined below:
~Email. PI referrals, employee, and subject referrals. Flyers posted around college campuses. Website clinicaltrial.gov."|
736955|NCT01346293|The study participants were enrolled from 28 April to 16 November 2012 at 70 clinic sites in the United States and Puerto Rico.|A total of 3372 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
736956|NCT01346189||
737144|NCT01335477||
737145|NCT01335464||
736957|NCT01346176|Recruitment took place in outpatient clinics at the Pereleman Center for Advanced Medicine at the University of Pennsylvania. Recruitment occurred from May 2010 - Feb 2012. No recruitment occurred between Oct 2010 - Jan 2011 while the first research nurse transitioned responsibilities to the second research nurse.|9,378 patients were assessed for eligibility. 9,246 were excluded. 8,299 did not meet inclusion criteria, 391 already had an advance directive, 322 were either missed in clinic, cancelled their appointments, or were hospitalized, 181 declined participation, 43 had their participation deferred by their physician
736958|NCT01346085||
736959|NCT01346072|100 patients were screened in two periods approximately six months each in duration at a dedicated Heart Failure Clinic at the University of North Carolina Chapel Hill. 43 patients met inclusion/exclusion criteria and had a blood sample sent for copeptin testing. Twenty-one patients were enrolled in the hospital phase of the study.|Blinded copeptin results were reviewed in 43 patients for participation in the hospital phase. 11 patients were selected by targeting the upper quartile of baseline copetin and 10 patients by targeting the lower quartile of screening copeptin levels. A total of 21 patients were enrolled in hospital phase.
736960|NCT01346059||All patients enrolled undergo a complete colonoscopy with placement of a 14 French colon decompression catheter (Cook Medical). Proper placement of the catheter in the cecum is verified by abdominal X-ray. Patients are randomized to either Saline or Vancomycin arms.
736961|NCT01345929||Two P3 protocols were initiated (NCT01345929 and NCT01345955) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. A total of 1083 subjects were randomized to both arms, 558 to NCT01345929 and 525 to NCT01345955. Of these, 552 and 516 received treatment.
736962|NCT01345786||
736963|NCT01345721|Subjects for this extension study were enrolled from only sites in Germany that participated in the parent study.|All enrolled subjects were included in the trial.
736964|NCT01345682||
736965|NCT01345669||This was a randomised, placebo-controlled, double-blind, parallel arms, multinational phase III trial in which patients were randomised 2:1 to Afatinib or Placebo.
736966|NCT01345630|Overall, 1423 participants were screened and 813 participants randomized in the study. A total of 797 participants were treated (396 were treated in the maraviroc + darunavir/ritonavir [MVC+DRV/r] group and 401 in the emtricitabine/tenofovir + darunavir/ritonavir [FTC/TDF+DRV/r] group). The study was conducted in 138 sites in 18 countries.|Participants were randomized to undergo either genotype testing or enhanced Trofile assay (ESTA) in a 1:1 ratio. Among participants who were identified as being infected with R5 tropic HIV-1 by either testing methods, 813 were randomized in a 1:1 ratio to receive 96-week treatment either in the MVC+DRV/r arm or in the FTC/TDF+DRV/r arm.
736967|NCT01345591||
736968|NCT01345513||
736969|NCT01345318||
736970|NCT01345292||
736971|NCT01345253|This study consisted of a 52 week blinded treatment period in Northeast Asia (China, Japan, Korea) which was followed by an optional open-label (OL) extension period in China for evaluation of belimumab in participants (par.) with active systemic lupus erythematosus (SLE).|A total of 707 par. were randomized, 705 received at least 1 dose of investigational product (Safety Population), 677 par. were included in the primary efficacy population (MITT Population) of which 663 were evaluable for the primary endpoint. The participant flow and baseline characteristics are presented for MITT Population (Pop).
736972|NCT01345240|The study was conducted in 4 phases, a Primary Vaccination Phase (up to Month (M) 3), a Safety Follow-Up Phase (M3-8), a First Immunogenicity Follow-Up (FU) Phase (M8-26), and a Second Immunogenicity FU Phase (M26 to study end at M51).|
736973|NCT01345188|Participants recruited from a cardiovascular clinic in Davenport, Iowa between 5/21/2012 and 11/22/2013|A total of 36 patients assessed for eligibility. Excluded were 8 patients (did not meet inclusion criteria=4; declined to participate=3;other=1). 28 patients were included in this randomized cross-over study.
736974|NCT01345162||
736975|NCT01345123|75,795 health plan members recruited via Interactive Voice Response Telephone Call Survey to screen for study eligibility. 30,556 persons completed the screen. 9,925 were study eligible (1. Reported pain in knee, hip, or back; 2. Considering treatment; 3. Had not already had surgery for pain; 4. Not on a 'Do Not Call' list).|
736976|NCT01345058||
736977|NCT01345019|This study was conducted at 259 centers across 29 countries in Europe, North America, Asia, Australia/New Zealand, and Japan. Participants were enrolled from 17 May 2012 to 29 March 2016.|"Randomization was stratified according to:
~intent to undergo autologous peripheral blood stem cell (PBSC) transplantation
~the antimyeloma agent being utilized/planned to be utilized in first-line therapy
~stage (International Staging System [ISS]) at diagnosis
~previous SRE (yes or no)
~region (Japan yes or no)"
736978|NCT01344876||
736979|NCT01344824|Patients were recruited from institutions including University of North Carolina Hospitals, University of Pittsburgh Medical Center, Mission Cancer Center, and New Bern Cancer Center.|From March 2010 to November 2013, 52 patients consented to treatment. 14 patients were consented and screened for eligibility but found ineligible.
736980|NCT01344759||
736981|NCT01344629||
736982|NCT01344616||
736983|NCT01344538||
736984|NCT01344460|The study was conducted at 55 study centers in 13 countries, between 16 May 2011 (first participant first visit) and 06 July 2012 (last participant last visit).|A total of 338 participants were screened, of which 317 were enrolled and 315 received the study drug. The 23 participants who did not receive the study drug included 9 screen failures and 12 premature discontinuations (10 participants withdrew consent and 2 participants for other reasons) and 2 participants never received the study drug.
736985|NCT01344447|The study was conducted at 56 study centers in 14 countries, between 12 May 2011 (first participant first visit) and 28 May 2014 (last participant last visit).|Of 504 participants screened, 17 did not complete screening; due to screen failure in 6, consent withdrawal in 6 and other reasons in 5 participants. Of 487 participants assigned to treatment, 479 received study drug and 8 prematurely terminated due to adverse event in 7 participants, and other reason in 1 participant.
736986|NCT01344369||
736987|NCT01344356||
736988|NCT01344226|Patients in one location of one surgeon's clinic about to undergo cataract surgery were recruited from July 2011 to May 2013.|patients had to be off of steroids for 14 days with no depot steroid injection for 30 days
736992|NCT01343888||All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
736993|NCT01343823||
736994|NCT01343693||
736995|NCT01343667||
736996|NCT01343485||
736997|NCT01343407||This was a 2-part study. Part 1 was a procedural pilot, performed first and including placebo run-in (Period 1), with no study drug administration. Part 2 began with pre-randomization placebo run-in (Period 1), followed by 3 randomized, crossover treatment periods (Periods 2, 3, and 4). The Participant Flow applies only to randomized participants.
736998|NCT01343368||
736999|NCT01343277||Total enrolled participants were 577, but 2 participants were randomized twice, therefore counted twice in enrollment. Thus, enrolled participants are reported as 579.
737000|NCT01343251||
737001|NCT01343095||
737002|NCT01343082||The run-in period of 4 weeks. Switched to DE-111 ophthalmic solution from Tafluprost ophthalmic solution 0.0015%, Timolol ophthalmic solution 0.5%, or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% . Treatment period: 52 weeks .
737003|NCT01343056||
737004|NCT01343043|This study was designed to determine whether New York esophageal squamous cell carcinoma 1 (NY-ESO-1) specific genetically engineered T cells recognized a human leukocyte antigens (HLA-A2) binding peptide from NY-ESO-1 induced antitumor responses in participants with synovial sarcoma.|A total of 50 participants were enrolled in this study. Out of 50 participants, 45 participants received NY-ESO-1 genetically engineered T cell infusion.
737005|NCT01343004||
737006|NCT01342965||
737007|NCT01342926|This study was a parallel-group randomized study consisted of a screening visit, where 240 participants entered the observation period (minimum of 4 months), a Baseline visit at the end of observation phase, where 191 were randomized, and was followed by the treatment period (18 months), and a follow-up visit (3 months) after last dose.|The total duration of participation was approximately 25 months following screening.
737008|NCT01342913||At Visit 1, participants entered a 2-week, single-blind (placebo) Run-in Period to obtain Baseline assessments of salbutamol use and to evaluate adherence with study treatment and procedures, diary card completion, and assessment of disease stability. At Visit 2, participants were randomized to a 12-week, double-blind Treatment Period.
737009|NCT01342887||
737010|NCT01342770|Ten subjects were pre-registered at one Cancer Prevention Network (CPN) member organization from 2011 to 2013.|Four participants were deemed screen failures (3 without histologically-confirmed non-small cell lung cancer (NSCLC) and 1 with metastatic NSCLC and were excluded from all analyses.
737011|NCT01342757|Recruitment closed|No events requiring changes in approach or enrollment criteria
737012|NCT01342666|From 1st of March of 2009 to 30 of April of 2011 we invited workers and patients from the INCMNSZ to participate in the study. Interested subjects were selected in a consecutive basis.|We performed clinical, nutritional, anthropometric, and biochemical evaluations. The protocol included a two-week run-in period with prescription of an isocaloric diet. Participants were instructed to minimize changes in diet, daily activities, specifically physical activity and smoking.
737013|NCT01342640||
737014|NCT01342549||
737015|NCT01342523|The recruitment period ran from November 28, 2011 through March 26, 2013. All study participants were recruited through the portal to the smokefree.gov website.|"Prior to randomization, potential participants were asked to make a confirmation call to an automated answering system to confirm willingness to perform study procedures. The call was intended to increase the likelihood that individuals would take treatment and follow-up calls. Randomization occurred immediately after the confirmation call."
737016|NCT01342510|Participants were recruited between 6/2011 and 10/2011.|200 participants were consented. The participants were distributed between the groups as follows, 39 participants in the control group, 38 in the lidocaine group, 44 in the magnesium group, and 37 in the magnesium/lidocaine group. Participants did not receive study drug if ASA score or peripheral IV inserted was not a 20 gauge.
737017|NCT01342484|Randomised, double-blind, placebo-controlled parallel group dose-finding study of linagliptin over 12 weeks in children and adolescents, from 10 to 17 years of age, with type 2 diabetes mellitus. Due to serious Good clinical practice (GCP) breach, 1 patient excluded from all analyses. So protocol section has 40 subjects and participant flow has 39|All patients suitable after screening underwent a 2-week open-label placebo run-in period before randomisation. Patients who successfully completed this period and who still met the inclusion/exclusion criteria were randomised to the 12-week randomised period in which they received either 1 of the 2 doses of linagliptin or placebo.
737018|NCT01342471|recruited by flyers and newspaper advertisements, were enrolled in a university-based PA program during the months of September through November, 2010.|
737019|NCT01342458|The participants were recruited from the primary care centre of the School of Medicine, University of São Paulo Hospital, and rheumatology ambulatory medical. Participants were recruited between March 2011 and December 2012, and allocated equally into one of two groups.|
737020|NCT01342445|Participants were recruited from student disabilities and health service offices at two univer- sities in the Northeastern United States (one public and one private).|Almost all participants completed all stages of the trial. One participant withdrew from the study after a possible adverse reaction.
737021|NCT01342341||
737022|NCT01342211||
737023|NCT01342172|The study opened to accrual at the Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah; the National Cancer Institute, Bethesda, Maryland;, and the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NewYork over the course of 19 months.|
737024|NCT01342107||
737025|NCT01342094||Prior to randomization all participants in the study were receiving Timolol ophthalmic solution 0.5% (one drop at a time, BID).
737026|NCT01342081||Switched to following three arms randomly from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily).
737027|NCT01342029||
737028|NCT01341990|Participants were recruited from 1 US study center.|
737029|NCT01341977||
737030|NCT01341912|This study was open to all patients who had completed the GENA-01 study with at least 50 exposure days after at least 6 months of study participation (EU patients) or at least 15 months of study participation (US patients). Overall 21 patients were eligible for this study but only 3 patients decided to participate in this extension study.|
737031|NCT01341782||
737032|NCT01341730|The study was terminated prematurely due to slow enrollment.|
737033|NCT01341652|Ninety-nine participants were enrolled between 2011 and 2016 at the University of Wisconsin; University of California, San Francisco; and Johns Hopkins University.|
737034|NCT01341639|Healthy infants 46 to 74 days old were enrolled in this study.|
737035|NCT01341600||
737036|NCT01341587||
737037|NCT01341470||
737038|NCT01341457||Participant study completion is defined as a participant completing the primary and secondary objective assessments.
737039|NCT01341444||
737040|NCT01341301||
737041|NCT01341067||
737042|NCT01340976||Part B participants who received 8 weekly doses and discontinued treatment were considered completers.
737043|NCT01340937||The infant series of vaccinations were those administered at 2, 4, and 6 months of age; the toddler vaccinations were those administered at 15 months of age. The Interim Period is the time between the last vaccination of the infant series and the time of administration of the toddler vaccination.
737044|NCT01340898||Out of 753 subjects enrolled, 3 subjects were not vaccinated and hence not considered to have started the study.
737045|NCT01340885||Study did not enroll enough subjects to reach meaningful results at the time of original conduct. While study data are/were retained per investigator responsibility, sincere attempts to access these data for retrospective analysis were unsuccessful.
737046|NCT01340872|Potential subjects were selected from the general population attending each centre in UK, DE, AT or HU for routine care of their IBD and anaemia. Individuals interested in participating were invited for the Screening visit in order to assess eligibility. Written informed consent was obtained prior to conducting any study specific assessments.|Subjects were males or females aged ≥18 years with a confirmed diagnosis of UC, required to be in remission have a mild-to-moderate UC (defined by SCCAI score <4 at entry); mild-to-moderate IDA (Hb concentration ≥9.5 g/dL and <12.0 g/dL for females and ≥9.5 g/dL and <13.0 g/dL for males; serum ferritin levels <30 μg/L at Screening.
737047|NCT01340794|This study opened on 10/3/2011 and enrolled 2 patients prior to temporarily closing on 2/28/2012 due to safety concerns. After review of AEs, an addendum was implemented which instituted changes to treatment administration, namely, 2 - 14 day run-in periods where patients received pazopanib PO days 1-7 and then were assessed for safety.|A total of seven patients were recruited to this study. One of the 5 patients registered to the study post-addendum cancelled prior to initiating treatment.
737048|NCT01340768||
737049|NCT01340664|This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin. The study was conducted between 27 June 2011 and 20 April 2012 and recruited patients from 60 study centers located in 7 countries worldwide.|A total of 279 patients were randomly allocated to the 3 treatment arms in the study. All 279 patients received at least 1 dose of study drug and were included in the modified intent-to-treat analysis set which was used for the efficacy and safety analyses.
737050|NCT01340651||
737051|NCT01340625||
737052|NCT01340586||A total of 18 participants were enrolled in this study. 16 participants were treated and completed the study. Two participants were enrolled but not treated (one withdrew consent, one enrolled as alternate).
737053|NCT01340573||
737054|NCT01340495||
737055|NCT01340482||
737056|NCT01340300|In a phase 2 RCT, stage I-III CRC & BC survivors at least 2 months from completing standard therapy were randomized. Major eligibility included absence of recurrence, absence of diabetes (glucose < 160 (random) or < 126 (fasting) mg/dl), and exercising < 120 min/wk. 1,426 patients screened, and 139 enrolled from September 2011 to December 2015.|Stratification factors: BMI (< 30 v > 30), gender, tumor site (CRC v BC)
737057|NCT01340209||
737058|NCT01340196||
737059|NCT01340144||
737060|NCT01340066|Participants were recruited from three medical clinics during the study period of 05/06/2011 to 05/17/2012.|Participants entered a one week placebo run in period to fulfill inclusion/exclusion criteria before being randomized.
737061|NCT01340053||
737062|NCT01340027|Male and female patients with symptoms of overactive bladder (OAB; urgency, urinary frequency and/or urgency incontinence) for at least 3 months. The study was conducted at 141 sites in 20 countries in Europe.|After screening, 1658 participants entered a 2-week, single-blind, placebo run-in period. After completion of the run-in period, 1307 participants were randomly assigned to 1 of the 12 treatment arms in a 1:1:1:1:2:1:2:2:2:2:1:1 ratio.
737063|NCT01340014|Participants were recruited from 11 study centers located in Europe.|This reporting group includes all enrolled participants as treated.
737064|NCT01339936|The subjects were selected from the existing clinical population of Optometric Technology Group Ltd (OTG Research & Consultancy). The subjects, fulfilling the criteria for inclusion were invited in a random fashion to participate in the study until the test population was achieved.|
737065|NCT01339923|The study was conducted in a total of a total of 26 sites; 4 sites in Brazil, 3 sites in Peru, 10 sites in Hungary, 9 sites in Spain.|All enrolled subjects were included in the study.
737066|NCT01339910|Participants were enrolled between June 2011 and April 2014 from 32 transplant centers|
737067|NCT01339897|Recruitment occurred between 06April2011 and 09August2011. This study was done at a single Phase 1 site.|
737068|NCT01339858||
737069|NCT01339832|All participants who were treated in ML18280 base study were followed-up two, three, four years and if necessary five years after the last surgery in Switzerland (5 centers) and data concerning to the adjuvant therapy, surveillance visit, tumor recurrence or second carcinoma and survival status were collected.|Of the 56 participants in the ML18280 base study, 51 were included in ML21875 study. Retrospective data was documented for 14 participants and prospective data was obtained for 37 participants.
737294|NCT01326962|The study was conducted at 3 centers ( 1 center was prematurely terminated) across the Kingdom of Saudi Arabia from 02 November 2011 to 12 May 2013.|
737070|NCT01339559|The study started to enroll patients in May 2011 and concluded in April 2019. 767 participants were included in the Enrolled Set but 1 participant from the United States of America was lost to follow-up and was excluded from the Safety Analysis Set.|Participants Flow refers to the Safety Set (SS).
737071|NCT01339429|Hospital wards were surveyed daily over the study period for eligible patients. Photographs of wounds ranging from 2-150 cm2 in size and clinical histories were reviewed for study enrollment eligibility criteria.|47 patients consented. 6 did not meet inclusion criteria. 1 voluntarily withdrew. 4 not enrolled due to clinical changes.
737072|NCT01339416|Participants were recruited and analyzed retrospectively from 3 clinical sites in the United States of America (Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University).|
737073|NCT01339403|Participants infected and uninfected with Human Immunodeficiency Virus (HIV) were recruited and analyzed retrospectively in the Kaiser Permanente HIV registry.|
737074|NCT01339390||
737075|NCT01339299||
737076|NCT01339273||
737077|NCT01339260||1455 patients randomized (ITT population), 1450 received study drug i.e. netupitant/palonosetron combination or palonosetron, both with dexamethasone, in cycle 1 (safety population-cycle 1), 1449 received chemotherapy and study drug (FAS), 1286 received study drug in multi-cycle extension (safety population-multi-cycle extension)
737078|NCT01339247||
737079|NCT01339091||
737080|NCT01339052|Patients enrolled from September 2011 through February 2014.|
737081|NCT01339013|September 2011 to January 2013, Medical Clinic|All recruited patients participated uneventfully.
737082|NCT01339000||
737083|NCT01338987||
737084|NCT01338870||All participants received placebo matched to PF-04991532 or placebo matched to sitagliptin tablet orally twice daily along with background metformin immediate release tablets, during the 2-week run-in period. Compliant participants were then randomized to study treatments for 12 weeks.
737085|NCT01338857|Study opened to recruitment 4/13/2011 and ended on 4/24/2012. Recruitment took place at the NYU Hassenfeld Children's Center outpatient clinic.|Participants were not excluded from the trial before assignment to groups. Treatment was based on age and diagnosis of neurofibromatosis type I.
737086|NCT01338818|Actual enrolment was 299 but one patient entered the extension but did not receive a single dose of the study medication and was subsequently excluded from the All Extension Patients Population|
737087|NCT01338792|The study was activated on June 14, 2006 and was closed to accrual on May 11, 2009 after accruing 47 subjects. Participants were recruited at LAC+USC Medical Center and the USC/Norris Cancer Hospital.|The study had no pre-assignment criteria.
737088|NCT01338649||
737089|NCT01338636||
737090|NCT01338610|Subjects were recruited from 16 investigative sites located within the United States. Participant flow data is presented for all subjects exposed to product.|Of the 334 enrolled, 210 subjects did not qualify for Run-In and were exited from the study without exposure to product. Of the 124 entering Run-In, 39 did not qualify for treatment. The 85 subjects qualifying for treatment were randomized 2:1 to receive either ESBA105 or Vehicle.
737091|NCT01338506||
737092|NCT01338493||
737093|NCT01338415|Participants in this 1-year extension study were pediatric patients who completed the 6-month randomized open-label core study AC-052-373. In addition, patients were required to have tolerated study treatment during the FUTURE 3 core study and were considered by the investigator to benefit from continued bosentan treatment.|64 patients were randomized in the FUTURE 3 core study, among whom 58 were enrolled in the FUTURE 3 extension study.
737094|NCT01338298||
737095|NCT01338025|Participants were recruited from 17 sites in the United States, Argentina, Brazil and Thailand. Enrollment occurred from May 10, 2011 to January 16, 2013.|Eligible participants were HIV-infected, ≥8 to <25 years of age with documentation of the M184V HIV resistance mutation, were failing their current antiretroviral regimen and were persistently non-adherent. Participants were randomized equally to the two study arms.
737096|NCT01338012||
737097|NCT01337986|Subjects were recruited from the John L Trotter Multiple Sclerosis (MS) Clinic at Washington University and through email blasts from the Gateway (St. Louis) MS Chapter. 53 participants meet the pre-screening criteria and signed an informed consent to be screened for the study.|Patients whose vision did not meet study criteria at the first visit in the affected eye or who had had steroids within 3 months of study entry were considered screen failures (n =7).Treatment group was randomly assigned by the pharmacist using a randomization table generated by a probability model.
737098|NCT01337973|Participants were recruited from June 2012-June 2015 from outpatient VA mental health programs (Substance Use Disorder, Substance use Disorder Intensive Outpatient, General Mental Health).|Of 1097 eligible for screening, 183 refused participation (17%), 75 (7%) were missed and 839 completed the screening assessment. Of those completing screening, 639 were not eligible for the RCT and 20 refused further participation. Thus, 180 out of 200 eligible veterans (90%) were randomized to one of the three treatment conditions.
737099|NCT01337960|Recruitment from greater Baltimore area was from IRB approved stroke registry and word of mouth|Seven subjects who were enrolled (via informed consent) did not receive the allocated intervention due to: relocation (3), lack of transportation (2), re-entry into physical therapy (1), and deemed too high functioning upon neurological re-examination (1). These pre-assignment losses were not counted in the subject tally of baseline assessments.
737100|NCT01337739|Subjects were introduced to the study in a clinic setting and allowed to review the consent prior to their operative procedure.|10 subjects were approached and all of the subjects agreed to participate.
737101|NCT01337700||
737102|NCT01337687||
737103|NCT01337674||
737104|NCT01337635||
737105|NCT01337609||
737106|NCT01337596||
737107|NCT01337336||
737108|NCT01337297|We started to recruit patients in 2011 in drug dependence specialized public outpatient service.|Of 70 patients, 20 filling including criteria and without excluding criteria were recruited. The remaining 50 either refused to participate or accepted but never showed up to the researcher center.
737146|NCT01335399||"E-Ld cohort: 374 participants were randomized. 371 participants entered the treatment period.
~Ld cohort: 374 participants were randomized. 371 participants entered the treatment period."
737109|NCT01337167||The infant series of vaccinations were those administered at 2, 4, and 6 months of age; the toddler vaccinations were those administered at 15 months of age. The Interim Period is the time between the last vaccination of the infant series and the time of administration of the toddler vaccination.
737110|NCT01337115|April 2011-February 2012. Consecutive patients for total knee arthroplasty at Orthopedic Department, Centro Hospitalar do Porto|Patients were excluded before randomization if refuse, could not use Visual Analogue Scale (VAS) scale, had contraindications for any of the components of the anesthesia protocol or, anesthesiologist was not expert in peripheral blocks
737111|NCT01337089|Participants enrolled in this study included those who had taken part in studies NCT01262651 (GWCA0958), NCT01361607 (GWCA0962), and NCT01424566 (GWCA1103) and who chose to continue treatment by enrolling in this study, as well as new (de novo) participants who met all inclusion criteria and did not meet any of the exclusion criteria.|For the de novo participants enrolled in this study, a screening visit took place 3 to 14 days prior to enrollment.
737112|NCT01337076||
737113|NCT01337050||
737114|NCT01336972|The trial was conducted in 29 participants at one center in The Netherlands. Participants were stratified based on their estimated glomerular filtration rate (eGFR): >60, 30-60 and <30 millilitres (mL)/minute (min)/1.73 meter squared (m2). eGFR was assessed using the 4-variable modification of diet in renal disease (MDRD).|The trial consisted of a 2- to 42-day screening period, a 3-week treatment period, and a 3-week post treatment period.
737115|NCT01336959||
737116|NCT01336933||
737117|NCT01336894|Thirteen (13) participants were accrued between August 2011 and January 2013. The study was terminated prematurely on May 15, 2013 due to lack of accrual. No further follow up data are expected as of that date.|Two participants on Arm I refused/withdrew prior to beginning of protocol interventions. These two participants were excluded from all analyses.
737118|NCT01336803||
737119|NCT01336764||
737120|NCT01336738||All participants received placebo matched to PF-04991532 or placebo matched to sitagliptin tablet orally once daily along with background metformin immediate release tablets, during the 2-week run-in period. Compliant participants were then randomized to study treatments for 12 weeks.
737121|NCT01336712||
737122|NCT01336647||
737123|NCT01336634|Eligible participants (par.) were enrolled in Cohort (Coh) A (monotherapy [Dabrafenib{DAB}]). Par. in Coh-A who had disease progression and adequately tolerating DAB were given option to crossover to Coh-B who received combination therapy (DAB+Trametinib). In Coh-C, par. without prior anti-cancer treatment received combination therapy.|Par. with metastatic non-small cell lung cancer (NSCLC) were screened and allocated to Coh-A (DAB twice daily [BID] i.e. monotherapy), Coh-B (Combination Second-Line Plus) and Coh-C (Combination First-Line) according to their eligibility. The results presented are based on the Interim Analysis.
737124|NCT01336621|Participants with partial-onset seizures (POS) who successfully completed the 20 weeks of treatment in parent study NCT01336621 were recruited in this open-label extension (OLE) study. The study was conducted in two periods, a primary treatment phase and a safety follow-up continuation phase (SFUCP).|Screening was performed on the same day as the final visit of the parent study NCT01336621. A total of 98 participants completed the parent study and opted to enter into this study. All participants received at least one dose of retigabine immediate release (IR) tablets.
737125|NCT01336608|A total of 3011 participants (par.) were screened, 559 entered the Run-in Period (RIP), of whom 444 were randomized and received at least one dose of study medication; 430 of these were included in the Intent-to-Treat (ITT) Population.|Eligible par. at screening entered a 2-week, single-blind placebo RIP to obtain albuterol (salbutamol) use at Baseline, and to ensure that par.'s COPD was stable at randomization. At the end of the RIP, par. meeting the randomization criteria entered the double-blind treatment period (TP) of 24 weeks (Wk).
737126|NCT01336569|Participants were recruited and enrolled from 4 study centers located in Brazil.|Of the 50 enrolled, 1 participant did not meet inclusion/exclusion criteria and was exited from the study prior to receiving study product. This reporting group includes all participants who received study product.
737127|NCT01336413||
737128|NCT01336296||
737129|NCT01336205|This multicenter study was conducted in the United States between 18 April 2011 and 03 December 2012.|The study duration was 54 to 58 weeks. New patients underwent an initial screening period lasting up to 2 weeks and a 2-week OIC confirmation period. New patients and patients enrolling from another study (also referred to as 'roll over patients') entered the 52-week treatment period, followed by a 2 week follow-up period.
737130|NCT01336140|Patients were recruited in the period from June 14, 2011 to May 14, 2012 in the stress testing laboratories of Rush University medical center and John H. Stroger, Jr. Hospital of Cook County (Chicago, IL.|427 patients were recruited. 122 patients were excluded: 50 refused; 35 met an exclusion criteria; 1 was previously enrolled in the trial; 26 had a contraindication to aminophylline. 5 consenting subjects were excluded: 3 had their regadenoson-stress clinically cancelled; 2 treatment assignment could not be verified (labeling error).
737131|NCT01336023|Countries: 19; Sites: 271; Number of sites as in parenthesis. Australia (7), Canada (14 ), Finland (5 ), Germany (12 ), Hungary (6), India (23), Ireland (2), Italy (6), Malaysia (5), Mexico (2 ), Russian Federation (11), Singapore (3), Slovakia (5), South Africa (13), Spain (8), Taiwan (3), Thailand (4), United Kingdom (16) and United States (126).|Subjects on metformin and/or pioglitazone treatment underwent a 26-week main trial and continued to enter an additional 26-week extension trial. Total duration of the trial was up to 55 weeks (2 weeks screening + 26 week main period + 26 week extension period + 1 week follow-up after last dose).
737132|NCT01335997||Sequence 1 (randomized) = 577; Sequence 2 (randomized) = 562
737133|NCT01335971||
737134|NCT01335932||
737135|NCT01335867||
737136|NCT01335789|Participants recruited between and March 2011 and August 2011 through community advertisements.|
737137|NCT01335750||
737138|NCT01335724||
737139|NCT01335698||Of 160 participants enrolled, 99 received treatment.
737140|NCT01335685|Participants took part in the study at 14 investigative sites in United States Canada, United Kingdom, Spain, and Czech Republic from 27 June 2011 to 29 December 2016.|Participants with a diagnosis of multiple myeloma (previously untreated) were enrolled to receive ixazomib orally at various doses in Phase 1. Only Arm B: Ixazomib 4.0 mg continued in Phase 2.
737141|NCT01335620||
737148|NCT01335230|We enrolled all the planned subjects (40) as suggested in our proposal within 15 months from University of Cincinnati outpatient clinic|We excluded patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases including rheumatoid arthritis, and any patients on systemic immunomodulators. Pregnant women were also excluded from the study.
737149|NCT01335204||
737150|NCT01335191||
737151|NCT01335061|Participation included 25 enrolled participants from 15 study centers and 9 countries.|The duration of participation was approximately 86 weeks, consisting of a Screening period (1 day to 4 weeks), Period 1 (on-demand treatment for 26 weeks), Period 2 (prophylaxis therapy for 52 weeks), and a follow-up safety period (4 weeks).
737152|NCT01334957|Adult hospitalized patients undergoing surgery|"Patients who met all the inclusion and none of the exclusion criteria during the Screening /Baseline Period were enrolled into the study.
~Subjects could not have a history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or NSAIDS."
737153|NCT01334944|Adult patients in the hospital setting experiencing pain and/or fever.|"Patients who met all the inclusion and none of the exclusion criteria during the Screening /Baseline Period were enrolled into the study.
~Subjects could not have a history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or NSAIDS."
737154|NCT01334918||
737155|NCT01334866|A total of 91 subjects were enrolled, with 89 subjects receiving the study treatment. The first subject was enrolled on December 30, 2009 and the last subject was enrolled on October 4, 2012. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.|
737156|NCT01334827||
737157|NCT01334723|The study utilized retrospective claims data from the Integrated Healthcare HealthCare Information Services, Inc. (IHCIS) database, a nationally representative managed care database that represents over 30 healthplans and more than 25 million lives.|Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
737158|NCT01334710||
737159|NCT01334606|Recruitment began at three medical research centers in March 2011. Due to slow enrolment, the study was terminated after 9 weeks.|There is no information for this section.
737160|NCT01334554|The recruitment started on 03/16/2011 and the first subject was screened on 03/17/2011. Participants were enrolled at Vanderbilt University Medical Center.|"We screened 132 participants. Eighty six participants were excluded because of the following reasons:
~80 did not meet inclusion criteria
~5 declined to participate after the screening visit
~1 excluded because of difficult intravenous access."
737161|NCT01334515||
737162|NCT01334229||
737163|NCT01334216||
737164|NCT01334125|This study was conducted at a tertiary institution. The first patient was recruited on March 3rd 2011, and the last study patient was recruited on August 1, 2013. The study was closed on August 8, 2013.|Following enrollment, all subjects entered a run-in phase of 3-month duration during which participants were placed on insulin aspart and insulin detemir, and the treat-to-target insulin regimen (TTIR) started.
737165|NCT01333956||
737166|NCT01333943||
737167|NCT01333865|Subjects were recruited by local print and Internet advertising. Participants were also recruited from the referral pool of patients in the Pediatric Psychopharmacology Program at the MGH and from the Alan and Lorraine Bressler Clinic and Research Program for ASDs.|
737168|NCT01333813|A total of 300 subjects were enrolled in the study. Among them 297 subjects were included in the Total Vaccinated cohort. Remaining 3 subjects were not included as they failed to meet protocol specified criteria and as such they are not included in the Participant Flow as Started.|
737169|NCT01333722||
737170|NCT01333592||
737171|NCT01333501||Total patients randomized in the study (157). Patients who took at least one dose of study drug are 151. The study there were 6 patients who were enrolled but who never took any dose of study drug.
737172|NCT01333488|Recruitment dates from 11/3/2011 to 3/10/2014 in Level one trauma center setting. Study was closed because of low accrual.|
737173|NCT01333475||"Because dual target evaluation of >70% was not observed in the tumor biopsies from any of the participants evaluated, no participants were enrolled to Cohort C to evaluate target recovery.
~TAC1 and TAC1A -Since all patients received both drugs, each of the TACs (Treatment Assignment Code) reflect the dose level."
737174|NCT01333436||
737175|NCT01333397|Study was performed as a multicentre study at eight investigational sites in France and Germany. Date of first enrolment: 30-Mar-2011 and Date of last completed: 27-Sep-2011.|A total of 178 patients were screened. 2 patient did not meet the entry criteria. 176 patients were randomized.Patients were randomized into 5 groups.
737176|NCT01333189||
737177|NCT01333111|Of the 40 sites that screened subjects, 39 sites enrolled subjects. The trial was therefore conducted at 39 sites in 13 countries, as follows: France (1); Germany (3); Italy (2); Japan (5); Macedonia (2); Malaysia (1) Netherlands (1); Russia (2); South Africa(1); Thailand (2); Turkey (3); United Kingdom (4) and United States (12).|
737178|NCT01333098||
737179|NCT01333072|80 participants were enrolled but 19 dropped from the study due to placebo response (16), parent withdrew child (2) and physician withdrew 1 subject. This left 61 subjects for randomization, as specified|
737180|NCT01333059||
737181|NCT01332994||After a screening period of up to 4 weeks, eligible participants were treated according to a predefined treatment algorithm based on disease response. In certain cases a re-screening was allowed. Participants were enrolled into the study with the administration of their first dose.
737182|NCT01332981|This post-HERMINE study was an observational, pharmaco-epidemiological, and retrospective study. Among the 102 participants who were alive at the end of the observation period in the HERMINE study, 69 were included in the post-HERMINE study from 31 centers in France. The study was conducted between 23 February 2010 to 15 October 2010.|Overall analysis population was 220. During data check for the participants alive at the end of HERMINE study, it appeared that 1 participant was included twice. Thus, the real no. that started treatment with 1st-line trastuzumab therapy was 220 and not 221. Thus, the no. of participants still alive at the end of HERMINE study was 102 and not 103.
737184|NCT01332851|DCFS volunteer scanned WA State DSHS database monthly (January 2011- January 2014); created list of possibly eligible families (N=1070). Potential participants contacted (n=556; n=514 unable to be contacted), permission received to forward their contact information to the study (n=251; n=172 ineligible, n=133 declined).|"4 participants were not randomized (2 already had the study intervention, 1 refused to sign the HIPAA agreement, and 1 was not located). 19 additional caregivers were enrolled post randomization when the study parent lost custody of their child. They were not randomized to a condition, but they were consented to participate and supplied data."
737185|NCT01332799||
737186|NCT01332721||
737187|NCT01332630|Metastatic breast cancer any receptors status with brain metastasis|
737188|NCT01332578|Participants were recruited at one clinical study site in Glasgow.|Of 37 participants screened, 12 participants did not meet the study criteria. Remaining 25 participants were randomized into the study.
737189|NCT01332500||
737190|NCT01332487||Participants were neither recruited nor enrolled in this retrospective observational study. Data from medical records or insurance claims databases were anonymized.
737191|NCT01332461|Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.|
737192|NCT01332435||
737193|NCT01332357||Participants were not recruited for, nor enrolled in, this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
737194|NCT01332331|This study investigated the safety and efficacy of a high and low dose ambrisentan (adjusted as per participants body weight) administered orally in participants aged 8 to 18 years with pulmonary arterial hypertension (PAH).|A total of 41 participants were enrolled and randomized.
737195|NCT01332318||
737196|NCT01332305||
737197|NCT01332292|Participants were enrolled into one of two cohorts based upon age; the younger cohort was enrolled after a review of the safety/pharmacokinetic data of at least six participants from the older cohort. Each participant was assigned to treatment randomly; assignment was not to be influenced by whether participants were in Cohort 1 or Cohort 2.|A Baseline assessment was carried out on Day 1 of the first treatment period. Participants were then randomized to one of the two possible treatment sequences (fluticasone furoate [FF] 100 µg followed by placebo; placebo followed by FF 100 µg). Results are reported by intervention, regardless of the age of the participant.
737198|NCT01332253||
737199|NCT01332227||Of 132 patients enrolled, 109 were randomized to receive treatment, and 23 patients were not randomized for the following reasons: 10 did not meet study criteria; 5 withdrew consent; 3 were lost to follow-up, and 5 withdrew for other reasons.
737200|NCT01332188|Subjects were recruited from one site in the US.|"101 subjects were enrolled, 7 subjects discontinued, and 94 subjects completed the study. The 101 subjects that met all inclusion criteria and none of the exclusion criteria were randomized to receive AC-170 0.05%, AC-170 0.1%, AC-170 0.24% or AC-170 0%.
~Note: All solutions were early formulations and not the final to-be-marketed formulation."
737201|NCT01332149|"All participants were Chinese. 626 participants were randomized initially, as originally stated on clinicaltrials.gov. However, 3 participants discontinued right after randomization without any treatment information. As such, the actual number of participants randomized and assigned to treatment was 623 as stated in the Started Row below."|
737202|NCT01332123||
737203|NCT01332071||
737204|NCT01332019|Study 105MS302 (NCT01332019) is an extension study and includes participants previously randomized to Study 105MS301 (NCT00906399). Only participants in Study 105MS301 who completed the study treatment and visit schedule through Week 96 were eligible for entry into this study.|Participants continued BIIB017 at the same dosage regimen they were following during treatment year 2 of Study 105MS301: BIIB017 125 μg subcutaneously (SC) every 2 weeks (Q2W) or every 4 weeks (Q4W). A major change in study design was introduced in Amendment 3 of the protocol, which switched all ongoing subjects dosing Q4W to dosing Q2W.
737205|NCT01331837||A total of 3080 patients were enrolled from 353 sites, across 31 countries
737206|NCT01331824||
737207|NCT01331694||
737208|NCT01331681|Participants with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye could participate in the study. The study was conducted at 73 study centers in Japan, European Countries and Australia between 09 May 2011(first participant first visit) and 30 Mar 2015 (last participant last visit).|Of 604 participants who were screened for inclusion in the study, 406 were randomized, and 404 received treatment.
737209|NCT01331408||
737210|NCT01331304||
737211|NCT01331291||
737212|NCT01331213|Participants were enrolled in the study between 4/2011 and 3/2012 at the Mayo Clinic in Rochester, Minnesota.|
737213|NCT01331161|Subjects were recruited from Atlanta and Denver from July 2011 until March 2012 using flyers|
737214|NCT01331109||
737215|NCT01331083||
737216|NCT01331005||
737217|NCT01330966||
737218|NCT01330953||
737219|NCT01330914|Women and men 25-70 years of age were recruited from two academic bariatric surgery centers (the University of California, San Francisco and the San Francisco Veterans Affairs Medical Center), where surgeons used the same standardized surgical approach to Roux-en-Y gastric bypass.|
737220|NCT01330628||
737221|NCT01330459|Subjects in this study are women 18 years or older, recruited from OHSU and PPCW who present for an elective termination of pregnancy up to 10 weeks 6 days gestation|
737222|NCT01330433||
737254|NCT01328756|This study enrolled participants from 3 antecedent studies (SPD489-317 [NCT01106430], SPD489-325 [NCT00763971], and SPD489-326 [NCT00784654]), or directly enrolled.|If participants from previous SDP489 studies had a gap of more than 7 days before participation in this study, they were required to have baseline Attention-Deficit/Hyperactivity Disorder (ADHD) total score of at least 28, to be enrolled. Of 348 participants screened, 314 participants were enrolled and treated.
737255|NCT01328743||
737256|NCT01328717||
737223|NCT01330420|All participants were being treated for depression with medications or psychotherapy at the MGH-Revere or MGH-Charlestown Health Centers. Referrals came from health center primary care providers (PCP's), mental health providers, or directly from patients themselves through postcards in the waiting areas.|Licensed independent clinical social worker (LICSW) Group Facilitators administered intake evaluations with the referred patients to obtain basic demographic and clinical information, determine if they were appropriate for the group based on the inclusion and exclusion criteria, and review their goals for group participation.
737224|NCT01330394|35 alcoholic subjects were recruited between October 2012 and January 2013 in diverse public outpatient services specialized in mental health|
737225|NCT01330381||Subjects who completed the 8 week double blind treatment period and wished to continue were re-randomized after the double-blind treatment period to the 16 week open-label treatment period. Out of 215 subjects randomized in the study, 213 subjects received treatment and 2 subjects withdrew consent before treatment.
737226|NCT01330355||
737227|NCT01330316|This was a multi-national, open-label trial enrolling two cohorts of patients with chronic Hepatitis C Virus (HCV) infection of genotype 1 (GT-1) who were randomized to the placebo arm (+ Pegylated interferon α-2a/ Ribavirin) and experienced virologic failure in one of the 1220.7 (NCT01358864), 1220.30 (NCT01343888), 1220.47 (NCT01297270) trials.|Eligible patients who entered the rollover trial within 14 weeks of their last study visit in one of the predecessor trials were not required to do a screening visit (treatment start: Day 1). Eligible patients who were outside of this 14-week window were required to do a screening visit (Visit 1) and started treatment at Visit 2 (Day 1).
737228|NCT01330303||
737229|NCT01330290|Patients participating in this study were in need of care either by family members at home or by professional nurses in outpatient care or nursing homes. The Participant Flow refers to the Enrolled Set (ES). All patients who were entered into the database are included in the Enrolled Set (ES).|The physicians were instructed to select idiopathic Parkinson's Disease (iPD) patients with documented need of care with caregivers/nurses who attended patients at home as caregiving family members or as professional nurses in outpatient care or nursing homes.
737230|NCT01330134||
737231|NCT01330108||
737232|NCT01330043|Adult cigarette smokers (N = 223) between the ages of 18 and 65 who smoked at least 10 cigarettes per day were included. Participants were randomized between 06/1/2010 and 01/22/2013.|Two participants were withdrawn from the study, of which one withdrew following a medication side effect of tachycardia and one participant was removed from the study for disruptive behavior -- both prior to randomization.
737233|NCT01330030||The original target enrollment was 230. Over recruitment led to a study sample size =243
737234|NCT01330017||
737235|NCT01329978|Participants were enrolled in a total of 42 study sites in the United States. The first participant was screened on 23 March 2011. The last participant observation was on 27 August 2012.|589 participants were screened and 332 were randomized and treated, and comprise the Safety Analysis Set.
737236|NCT01329939|Atopic asthmatics age seven and above seen in pulmonary and allergy clinics were approached over a 2.5 year period.|Potential subjects underwent spirometry with bronchodilator administration if there was no previous documentation and allergy testing (skin/blood) to evaluate for environmental allergies.There was a four to six week run-in period where all participants were maintained on an inhaled corticosteroid before randomization.
737237|NCT01329900||
737238|NCT01329848||
737239|NCT01329679||
737240|NCT01329562|Subjects between the ages of 18 and 45 were recruited from two investigative sites. Subjects were enrolled from May 9,2011 through March 29, 2012. Last patient out June 5,2012.|Subjects were enrolled and randomized at Visit 1. There were no significant events between enrollment and assignment.
737241|NCT01329549||
737242|NCT01329419|The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Hepsera in the real clinical setting after launch.|
737243|NCT01329380|Four hundred and three participants were registered at 195 sites in Japan. Survey forms were available for 400 participants from 194 sites.|
737244|NCT01329328||
737245|NCT01329263|Participants were recruited from the local Philadelphia area via newspaper and internet advertising. Former study participants who had agreed to be contacted for future studies were also contacted. Recruitment began October 2010 and was completed November 2011.|Subjects were required to complete a 5 day baseline assessment of smoking their own brand cigarette. Participants who did this were given study cigarettes. 87 participants signed consents at the first session, 3 did not finish the session. 60 subjects did the 5 day baseline smoking, returned on Day 5, were randomized and included for analysis.
737246|NCT01329198||
737247|NCT01329185||
737248|NCT01329029|Participants took part in the study at 203 investigative sites in Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Korea (Republic of), Netherlands, Poland, Russia, Slovak Republic, South Africa, Spain, Turkey and United Kingdom from 28 May 2011 to 27 May 2014.|Participants with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) entered a 4 week baseline period during which all patients received placebo then were enrolled equally in 1 of 2 treatment groups, once a day placebo or roflumilast 500 µg.
737249|NCT01328964|This was a retrospective observational study utilizing a large managed care database with linked pharmacy and medical claims. The dose of each inhaled corticosteroid was not known in the database.|
737250|NCT01328951||"The study consisted of three periods: a Blinded Phase (BP), an Open-Label Phase (OLP), and final Survival Follow-Up (SFU). These periods were not necessarily sequential, because the OLP could be skipped in select participants. Therefore, the reasons for discontinuation are presented altogether within the Overall Study."
737251|NCT01328873|Recruitment period - May 2011 - Sept 2015 Patients were identified in either the outpatient clinic or inpatient BMT/Leukemia unit|Patients were excluded only if they refused to participate or required antibiotic changes within the 7 days prior to being approached for the study. An additional 2 pateints were considered screen failures for this study and did not proceed.
737252|NCT01328782||
737253|NCT01328769||
737257|NCT01328587||
737258|NCT01328574||
737259|NCT01328548||
737260|NCT01328535||
737295|NCT01326923||
737262|NCT01328444|Participants (par.) who were eligible completed a 12- to 21-day Run-in Period followed by two 12-week treatment periods.|A total of 596 par. were enrolled and screened, 409 par. entered the Run-in Period, 349 par. were randomized and 348 par. received study treatment. Participant Flow data are presented by treatment rather than sequence. Par. received 2 out of the 6 interventions.
737263|NCT01328431||
737264|NCT01328405||
737265|NCT01328379|Patients were to be enrolled at a minimum of 60 investigational centers in the United States until a minimum of 405 patients had been randomized.|
737266|NCT01328366||
737267|NCT01328249||A total of 81 participants were enrolled out of which 2 participants did not receive eribulin mesylate and were excluded from the eribulin-treated analysis sets (79 participants made up the Eribulin-treated Analysis Set and Eribulin-treated Safety Analysis Set).
737268|NCT01328184||
737269|NCT01328158||Survey forms were collected from 236 patients. 16 participants completed treatment with Lopinavir/Ritonavir tablets before the start of enrollment in this study and were excluded from the analysis.
737270|NCT01328080|Participants were recruited from patient populations evaluated by the Johns Hopkins Department of Dermatology located at the Johns Hopkins Outpatient Center between April 2011 through April 2012. Participants were also be recruited from other patient populations at the Johns Hopkins Hospital through the use of advertisements.|Prior to UVB treatment,each subject's Minimal Erythema dose (MED) was determined. Exclusion criteria: photosensitive disorders,skin cancer,previous radiation therapy,use of photosensitizing drugs,lidocaine allergy,bleeding disorders,pregnancy,and lactation. Wash out: 4 weeks for antibiotics/corticosteroids, 6 months for oral isotretinoin.
737271|NCT01328054||All participants (par.) underwent screening assessments within 14 days prior to the start of study treatment to determine their eligibility for enrollment. Study treatment was administered over a period of 5 days, and an End of Study visit was conducted on Day 8-11.
737272|NCT01328041|Participants (par.) having documented Human immunodeficiency virus type 1 (HIV-1) infection with a plasma HIV-1 Ribonucleic acid(RNA) >=500 copies per milliliter (c/mL) at Screening, Antiretroviral therapy (ART)-experienced and on stable ART for at least one month prior to Screening were enrolled|A total of 139 par. were screen failures and 183 par. entered the single arm, open-label study.
737273|NCT01328002|Participants were recruited over a 12 month period from April of 2011 to April of 2012 at 47 study sites in the United States.|116 patients took at least 1 dose of open-label investigational product; 20 patients were randomized to receive double-blind treatment.
737274|NCT01327989||
737275|NCT01327976||
737276|NCT01327963|124 patients were eligible to participate in the study, but 110 signed consent and started the study. Of the 14 that didn't start, 13 could not be reached at start of study and one patient did not receive the TIF procedure due to intraoperative hematoma.|
737277|NCT01327885||
737278|NCT01327846|"10066 patients enrolled in the Core phase (4 randomized groups); 5 patients enrolled in the safety set were not included in efficacy set. 5777 patients continued in the Extension phase (539 entered only the washout period, 5238 entered the treatment period(s)). The Core phase completed as planned; terminated applies to the Extension phase."|A total of 17482 patients were screened, and 10102 patients completed the screening phase. A total of 6430 patients did not complete the screening phase due to screen failure.
737279|NCT01327703||
737280|NCT01327677||
737281|NCT01327651|The study enrolled men, and transgender women, who have sex with men at a community clinic and clinical research site (CRS) in Bangkok, Thailand, and a CRS in Harlem in New York City, USA. Women were enrolled at a study site in Cape Town, South Africa. The last participant was enrolled in May of 2014|Of the 902 screened participants, 622 were eligible to be enrolled into the study, and participated in a 6-week lead-in period of directly observed dosing (DOD) of one tablet once-weekly of FTC/TDF for five observed doses followed by 1-week off drug. 86% (N=536) completed the lead-in period and were randomized to the three arms.
737282|NCT01327599|Participants were recruited from 10 study centers in France and 3 study centers in Germany.|This reporting group includes all enrolled participants.
737283|NCT01327573||
737284|NCT01327547|In this study, 138 participants were randomized, of which 137 participants received the study drug. Participants were randomized at 37 sites in 9 countries. Five sites received drug and screened subjects but did not randomize any subjects; 2 sites received drug but did not screen any subjects.|One participant who was randomized into the study was withdrawn prior to receiving treatment due to poor venous access.
737285|NCT01327508||
737286|NCT01327495|Healthy males, 25-55 years old, were recruited via advertisement: flyers and newspaper ads at the University of Washington.|98 screened. 28 screen fails (or did not finish screen). 8 subjects dropped out prior to drug start. 62 subjects started drug. 7 subjects dropped after drug start/pre-drug finish. 2 dropped after finishing study drug, but prior to prostate biopsy. 2 subjects dropped from analysis for non-compliance. 51 completed entire study, included in analysis.
737287|NCT01327482||
737288|NCT01327339|The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Requip under the real clinical setting after launch.|
737289|NCT01327313||
737290|NCT01327300|Participants were recruited from the gastroenterology specialty clinics at the University of Florida or by referral from other primary care physicians. Recruitment was from 2011 until March, 2012|A washout period of 3 weeks was given between treatment periods with 2 weeks prior to recruitment.
737291|NCT01327274||
737292|NCT01327157|There was a selection of sixty-five patients with traumatic and idiopathic palsy of the Otorhinolaryngology UNIFESP, between June 2008-March 2009, according to the criteria of inclusion and exclusion, resultram forty-four, of whom 30 did not participate, resulting in 14.|Some patients were excluded because they did not agree to be randomized, others could not be present at every visit, or were co-interventions.
737293|NCT01327053|Randomization was stratified across the two treatment arms according to the stage of disease (laBCC or mBCC), histological subtype (non-aggressive or aggressive for laBCC patients) and the regions (Australia, Europe, and North America).|All eligible, enrolled patients were randomized in 1:2 ratio to sonidegib treatment with either 200 mg or 800 mg once-daily dose. In total, 230 patients were evaluated as FAS population: 79 and 151 patients randomized to 200mg and 800 mg sonidegib respectively. However, 1 patient randomized to 800 mg sonidegib did not receive study treatment.
737298|NCT01326780|18 investigational sites: First patient enrolled: 08 March 2011, Last patient completed: 02 March 2012|male and female subjects with moderate facial acne vulgaris, who met the entry criteria, were randomized with equal allocation to either 1.2%, 2.4%, or 3.6% JNJ 10229570-AAA cream or color-matched vehicle
737299|NCT01326728||
737300|NCT01326702||
737301|NCT01326546||
737302|NCT01326533||
737303|NCT01326481||
737304|NCT01326026|The trial was conducted at 43 sites in 4 countries: Finland (5), Germany (6), Spain (6) and United States of America (26).|Subjects continued on metformin treatment at the pre-randomisation dose level and dosing frequency.
737305|NCT01325870||
737306|NCT01325792|104 subjects recruited from 9 sites in the US and Netherlands between March 2011 and December 2012|
737307|NCT01325714||
737308|NCT01325701||A total of 78 subjects were enrolled: 70 were treated with PCI-32765 (ibrutinib) 560 mg daily, and 8 were treated with ibrutinib 840mg daily. All subjects received at least 1 dose of study drug.
737309|NCT01325623|Eligible subjects were at least 18 years old, with a clinical diagnosis of medically refractory epilepsy dominated by partial seizures suitable for implantation with the Model 106 VNS Therapy System and a history of ictal tachycardia, defined as heart rate above 100 bpm during a seizure and at least a 55% increase or 35 bpm increase from baseline.|A total of 35 subjects were screened; (4) did not meet study criteria, (31) were treated/implanted with the AspireSR® VNS Therapy® System, of which (1) was implanted with version 1 of the AspireSR® VNS Therapy® System and (30) were implanted with version 2 (= ITT population).
737310|NCT01325584||
737311|NCT01325532|Subjects were recruited by advertisement from our Depression Clinical and Research Program (DCRP). Informed consent was obtained per IRB guidelines. Investigators who screened subjects were our program's psychiatrists and psychologists, trained and certified in the use of appropriate diagnostic instruments such as the SCID and HAM-D.|Subjects who passed the screen visit returned a week later for the baseline visit. At that time, subjects received their first treatment (or sham) at the site for 20 minutes, including personal instruction of proper technique and electrode placement.
737312|NCT01325493||
737313|NCT01325428|This was an open-label study conducted in two sequential parts (Part A in which patients were treated with Afatinib (BIBW 2992) as monotherapy; Part B in which patients were treated with Afatinib plus Vinorelbine as combination therapy after progression on Afatinib monotherapy).|Part A: Patients were treated with Afatinib and could continue on treatment until first Progression of Disease (PD), intolerable side effects, or withdrawal of consent. Upon first PD, patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with weekly Vinorelbine.
737314|NCT01325350||
737315|NCT01325337||
737316|NCT01325311||
737317|NCT01325207|The study opened for accrual on April 26, 2011 with first patient being treated August 1, 2011, with an accrual goal of up to 48 patients for phase I/II combined. Amendment 5 added 5th cohort to allow higher dose. The study was suspended April 12, 2014 and reopened on August 28, 2014 for phase II. The study closed to accrual June 2, 2016.|
737318|NCT01325181||
737319|NCT01324999||
737320|NCT01324947||CC-4047-MM003C is a companion study for the trial CC-4047-MM-003 (NCT01311687). CC-4047-MM-003C enrolled those who discontinued treatment with dexamethasone alone (Treatment Arm B) in the CC-4047-MM-003 trial due to disease progression; those who had discontinued treatment with pomalidomide plus dexamethasone (Arm A) were not eligible to enroll
737321|NCT01324882|Patients were recruited from study initiation 1/31/2011 until June 30,2011. Patients were recruited from the clinic.|No details to report
737322|NCT01324830||
737323|NCT01324700||
737324|NCT01324687||We excluded 15 individuals from analysis because they left the facility and the study less than 1 month after starting, and they were significantly different than the rest of the population. We felt that they has been mistakenly accepted into an independent or assisted living and recognized this and moved out to an alternate level of care.
737325|NCT01324622||
737326|NCT01324570|First Patient First Visit: 23-July-2012; Last Patient Last Visit: 23-May-2016. The study was conducted at 33 study centers in the United States|
737327|NCT01324453||
737328|NCT01324440||
737329|NCT01324401||
737330|NCT01324388||
737331|NCT01324349|Subjects who were scheduled for non-emergent, open hepatic surgery were assessed for potential study eligibility via a screening/baseline assessment performed within 30 days of their scheduled procedure.|Subjects who met the pre-operative eligibility criteria were considered for study participation. During the surgical procedures, subjects who met the intra-operative eligibility criteria were randomized. Subjects who did not meet all criteria were considered screen failures and not randomized.
737332|NCT01324323|The study was conducted at 3 study centers (2 in the United States and 1 in the United Kingdom). The first subject was enrolled in April 2011 and the last subject completed the study in Feb 2012.|
737333|NCT01324310|The recruitment period occured over 6 months; the first participant enrolled on 01 July 2011; the last participant completed was 04 Jan 2012; 3 participating sites were involved (2 sites from the US and 1 in the UK); Overall, 15 subjects with advanced cancer were enrolled to ensure there was a minimum of 12 evaluable subjects|
737334|NCT01324271||Lead-ins & study cohort included (n=85). Same criteria/procedure for all 85 subjects. Study phases did not have different start/end dates. Periods/dates for lead-ins & cohort not different. Physicians with no TTDS experience were required to perform lead-ins in OR (n=26/85). Sites on-boarded and completed lead-ins at different times.
737335|NCT01324128|The first 100HD subjects that completed Stage 1 in the PA21 treatment group entered Stage 2 and were randomised to PA21 Maintenance Dose (MD) or PA21-1 Low Dose (LD). Due to a randomisation error only 99 subjects were randomised into Stage 2.|
737336|NCT01324102|Participants identified through cancer registry who were: diagnosed with cancer (any type) Stage 1-4 within the past three years; received surgery, chemotherapy, or radiation treatment; no psychotic or dementing disorders; and not currently in hospice care.|No participants were excluded prior to assignment.
737374|NCT01322009|Children 2-18 years-of-age after severe TBI (Glasgow Coma Scale [GCS] score ≤8) recruited from November 2011-September 2013 at a single, tertiary Children's Hospital.|
737337|NCT01324024|55 participants were consented for screening over the course of 2 years at an outpatient research site in Philadelphia, PA.|Of the 55 who were consented for screening, 20 did not meet inclusion criteria and of the remaining 35, 32 participants completed the study.
737338|NCT01323998||Participants were neither recruited nor enrolled in this retrospective observational study. Data from medical records or insurance claims databases were anonymized.
737339|NCT01323972||Out of the 327 subjects originally enrolled, 7 dropped out of the study before receiving the first vaccination.
737340|NCT01323959||Out of the 212 subjects enrolled, 1 subject number was allocated without the study vaccine being administered to that subject, therefore the total number of subjects was 211.
737341|NCT01323946||During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
737342|NCT01323920||
737343|NCT01323855|Male or female adults with different degrees of renal impairment along with matched healthy adults with normal renal function were selected for this study.|
737344|NCT01323790|This multicenter study was conducted in Belgium, Croatia, Czech Republic, Hungary, Spain, Sweden, United Kingdom, and the United States between 28 March 2011 and 20 September 2012.|The study duration was up to 18 weeks, consisting of an initial screening period lasting up to 2 weeks, a 2-week OIC confirmation period, during which the diagnosis of OIC and stability of the opioid regimen were confirmed, a 12-week treatment period, and a follow-up visit 2 weeks after the last dose of study drug.
737345|NCT01323777|Subjects were recruited from 2 study sites located in Japan.|This reporting group includes all implanted subjects (65).
737346|NCT01323673||
737347|NCT01323660|Participants (par.) who were eligible completed a 12- to 21-day Run-in Period followed by two 12-week treatment (trt) periods.|A total of 634 par. were enrolled and screened, 393 par. entered the Run-in Period, 308 par. were randomized and 307 par. received study trt. Participant Flow data are presented by treatment rather than sequence. Par. received 2 out of the 6 interventions.
737348|NCT01323647||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
737349|NCT01323634||At Visit 1, participants entered a 2-week, single-blind (placebo) Run-in Period to obtain Baseline assessments of salbutamol use and to evaluate adherence with study treatment and procedures, diary card completion, and assessment of disease stability. At Visit 2, participants were randomized to a 12-week, double-blind Treatment Period.
737350|NCT01323621||At Visit 1, eligible participants entered a 2-week, single blind (placebo) Run-In Period to obtain Baseline assessments of albuterol (salbutamol) use and to evaluate adherence with study treatment and procedures, diary card completion, and assessment of disease stability. At Visit 2, participants were randomized to a 12-week Treatment Period.
737351|NCT01323595|Patients undergoing testicular sperm extraction surgery|No exclusions except allergy to treatment agent (celecoxib)
737352|NCT01323582||
737353|NCT01323517||
737354|NCT01323478|Patients eligible to participate in Study 13267B were patients who had completed lead-in Study 13267A (NCT01140906) immediately prior to inclusion into present study, 13267B. The doses of Vortioxetine used in this long-term safety extension study were the same as those used in lead-in Study 13267A (NCT01140906).|The study consisted of a 52-week open-label period and a 4-week Safety Follow-up Period.
737355|NCT01323387||
737356|NCT01323270||A total of 753 participants were enrolled in this study. Of these, 4 participants were not randomized but were vaccinated rLP2086 vaccine or Repevax or Saline at Vaccination 1. These participants were included in safety population and not intent-to-treat population.
737357|NCT01323192|The study was conducted at 39 study sites in Japan.|284 participants were randomly assigned and treated with JNS001 or placebo in this study. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.
737358|NCT01323153||
737359|NCT01323140||
737360|NCT01323010||
737361|NCT01322971||151 participants were screened ; 2 were randomized
737362|NCT01322945|Eligible adult patients were identified in the outpatient neurosurgical clinics at the Barrow Neurological Institute between October 2010 and June 2011.|
737363|NCT01322841||
737364|NCT01322815||
737365|NCT01322633||
737366|NCT01322607|Hemiparetic stroke survivors (>6 months) with residual hemiparetic gait in women/men aged 30-85 years who completed all therapy were recruited. They had to have adequate language and neurocognitive function, give adequate informed consent, able to rise from a chair unaided, and able to walk 10 meters without human assistance.|
737367|NCT01322594|A total of 31 participants provided written informed consent and participated in the study at 3 sites in South Africa (2 sites) and the United Kingdom (1 site) between 24Feb2011 and 25Nov2011.|Eligibile participants in the 10 and 30 mg dose groups received MEDI2338 in an open-label manner. Eligible participants in the 100, 300, and 1000 dose groups were randomized in a 3:1 ratio to receive MEDI2338 or placebo.
737368|NCT01322490|Phase 3, randomized, placebo-controlled, multicenter, multi-country efficacy trial of PROSTVAC administered SC to adult males with asymptomatic mCRPC, and was designed to enroll approximately 1200 men. Subjects were randomly assigned with equal probability (1:1:1) to one of three double-blind treatment arms.|Screening activities were completed within 28 days prior to the first dose of any medication and were completed prior to dosing. Subjects who required anti-androgen wash-out specifically for this protocol were consented prior to beginning withdrawal of therapy, however, no other screening procedures were performed the subject was deemed eligible.
737369|NCT01322386|Participants were recruited by the Physician and research team at Lucille Packard and Stanford Hospital and Clinics from 2007 - 2010. The first participant was enrolled in November 2008, and the last participant was enrolled in October 2010.|11 PSC patients whose consent to participate was obtained did not participate in the Study.
737370|NCT01322360|Recruitment 06 May 2011 to 10 April 2012. A total of 75 subjects were screened and 50 subjects were enrolled (i.e., received at least 1 dose of study drug)|Only eligible pediatric subjects who signed the informed consent and completed all screening procedures within 14 days before the surgery were enrolled in the study.
737371|NCT01322347||
737375|NCT01321879|Recruitment Period: March 2011 and May 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|One participant was excluded from the study because of a failed screening test result and did not receive treatment.
737376|NCT01321749||
737377|NCT01321723||
737378|NCT01321710||
737379|NCT01321697||
737380|NCT01321606||
737381|NCT01321554|Participants took part in the study at 117 investigative sites in Europe, North America, Asia Pacific, Japan, and Latin America from 17 March 2011 to 19 March 2019.|A total of 612 participants were screened for entry into the study. Of these 612 participants, 220 participants were screening failures and 392 participants were randomly assigned to receive either lenvatinib or placebo in a 2:1 ratio.
737382|NCT01321073||
737383|NCT01321008|Recruitment Period: May 20, 2011 to May 8, 2013. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.|Study was terminated early due to extensive revisions to the study.
737384|NCT01320943|Participants were enrolled at 13 study sites in Germany. The first participant was screened on 26 April 2011. The last study visit occurred on 23 August 2016.|65 participants were screened.
737385|NCT01320826|Patients were enrolled if they were undergoing a colonoscopy for any reason with one of the participating study primary care colonoscopists. Due to staggered local study start dates, data collection occurred between March 15, 2010 and June 14, 2010 and patient satisfaction phone surveys were completed by August 2010.|
737386|NCT01320735||From 300 participants enrolled in the study, data of 17 participants from one of the sites were excluded from analysis because of the impossibility to contact the investigator for data clarification. Hence 283 participants were included in the analysis.
737387|NCT01320722||
737388|NCT01320683||
737389|NCT01320553||
737390|NCT01320293||
737391|NCT01320202||
737392|NCT01320150||
737393|NCT01320137||
737394|NCT01320072||
737395|NCT01320033|This study was conducted in United States between 29 March 2011 (first participant first visit) to 3 January 2012 (last participant last visit).|A total of 662 participants randomized the study and dispensed with study drug out of which 487 completed study.
737396|NCT01319994||"Patients were recruited into Prevention and Treatment algorithms initially. However, only the Treatment algorithm proved feasible for logistic reasons. Below are the results relating to patients randomized into the Treatment algorithm."
737397|NCT01319929||
737398|NCT01319877||Three enrolled participants received third-line therapy and were not included in the evaluable population.
737399|NCT01319851|Patients were enrolled at the Aflac Cancer and Blood Disorders Center within Children's Healthcare of Atlanta (CHOA) from November 2010 to November 2011.|One subject with Fanconi Anemia (FA) received fludarabine (Flu) 25 mg/m2 on days -10 to -5 and cyclophosphamide (Cy) 10 mg/kg on days -5 to -2. The other two subjects received Flu 25 mg/m2 on days -6 to -1, Cy 50 mg/kg on day -2, and low-dose total body irradiation(TBI; 200 cGy) on day -1.
737400|NCT01319812||
737401|NCT01319799||
737402|NCT01319773||This study included a parallel-group phase (PGP) and a paired-eye phase (PEP). The paired-eye phase of the study began after the parallel-group phase completed. The parallel-group phase enrolled healthy volunteers and the paired-eye phase enrolled patients with dry eye symptoms.
737403|NCT01319760|Five roll-in subjects were enrolled in the MINI-AMI feasibility study between September 14, 2011 and April 24, 2012. A total of 82 patients have been screened but not enrolled by participating sites during the study period. Five (5) sites participated in the MINI-AMI study.|The study experienced a very low enrollment rate (lower than expected). The study was terminated before the roll-in phase was completed. No data for primary or secondary endpoints were collected in this study
737404|NCT01319721|The patients, who had one or two eye(s) with unilateral recurrent pterygium, were consecutively recruited from Zhongshan Ophthalmic Center, Guangzhou, between December 2010 and May 2013. In cases of bilateral eyes with recurrent pterygium, the left eye was the first to be assigned randomly, followed by the right eye.|
737405|NCT01319617|Recruitment from medical clinic from January to September 2011|
737406|NCT01319552|The recruitment of volunteers began in December 2008 and ended in October 2010. All the volunteers were recruited at Columbia University.|
737407|NCT01319539|12 participants were enrolled between September 2011 and March 2013.|
737408|NCT01319500|A representative sample of 100 Croatian gynecologists and 31 dermatologists were asked to fill in a questionnaire for each of their oral contraceptive (OC) prescriptions from February 16, 2009 to March 15, 2009. Questions included the name of the OC, date and reason for prescription, and the reproductive status and demographics of the patients.|
737409|NCT01319422|Recruitment took place at an academic medical center.|"Four screened subjects did not meet eligibility criteria. Forty subjects were enrolled, but one withdrew after randomization without receiving treatment, and is listed as a non-completer. Thus, data are presented for 39 participants."
737410|NCT01319396||
737411|NCT01319383|Potential HIV infected participants who were durably suppressed (<50 copies/mL) on stable ART with a CD4 count >300/μL were recruited from the UNC ID clinic and UNC AIDS Clinical Trials Unit. Twenty seven (27) participants were screened for both study periods, 25 unique individuals enrolled between February 2011 and March 31, 2016.|Participants were recruited into the single and multiple dose Vorinostat (VOR) Arm alone, the VOR Interval Dosing Arm alone, or both = 25. Each Arm had multiple steps. Participants without a significant in vitro or in vivo response to VOR did not advance in either Arm; 3 Arm 1 and 13 new participants, enrolled Arm 2.
737412|NCT01319318||
737413|NCT01319110||
737414|NCT01319045||
737415|NCT01318993|Participants were eligible to enter the study if they completed the placebo-controlled induction study CCX114151; completed the maintenance study CCX114157 at Week 52; or withdrew from the maintenance study CCX114157. A total of such 800 participants were planned to be enrolled.|All participants entered the study at a Baseline visit, Week 0, and received GSK1605786A 500 milligrams (mg), twice daily (BID) for 216 weeks.
737416|NCT01318967||
737417|NCT01318915||
737518|NCT01313299|This multicenter study was conducted in 34 investigational sites. Subjects screened were 281 and randomised and treated were 243.|
737418|NCT01318902|Participants took part in the study at 9 investigative sites in the United States, Canada, France, Germany and Italy from 27 April 2011 to 13 November 2018.|Participants with previously treated systemic light chain (AL) amyloidosis were enrolled in 2 dose escalation cohorts and were treated with ixazomib 4.0 or 5.5 mg. Participants with relapsed or refractory amyloidosis were enrolled in 2 dose expansion cohorts and treated with ixazomib 4.0 mg in proteosome inhibitor (PI) Naive and PI Exposed groups.
737419|NCT01318876||
737420|NCT01318811||
737421|NCT01318733||
737422|NCT01318694|Of the 1580 patients screened at multiple global sites, 1081 (68.4%) were randomized and 499 (31.6%) discontinued from the study prior to randomization.|Due to mis-randomization, four patients did not have a baseline visit and never started study medications. They were included in screened and randomized, but excluded from the Full Analysis Set and the Safety Set.
737423|NCT01318577||
737424|NCT01318538|Subjects were recruited at McLean Hospital in Belmont, MA and SSTAR Inc. in Fall River, MA using advertisements, flyers, and clinician referrals. At both sites, subjects were recruited from inpatient, residential, partial hospital and outpatient programs. Those recruited from inpatient or residential settings started the groups after discharge.|Group therapists provided feedback about the groups that they ran, but were not technically enrolled in the study and therefore are not included in initial enrollment number.
737425|NCT01318512||Study included Titration Period (4 months) and Maintenance Period (6 Months).
737426|NCT01318499|Patients were randomized from 37 investigational sites in the US.|Of the 1342 enrolled patients, 60 withdrew before the start of dosing. Baseline characteristics are presented on all randomized patients with at least one postoperative assessment (intent-to-treat): 1257
737427|NCT01318408||
737428|NCT01318382|Participants were recruited at 8 sites in Canada between June 2011 and May 2012.|
737429|NCT01318278||
737430|NCT01318135|Participants enrolled at 58 investigative sites in Japan from 06 January 2009 to 23 January 2010.|Participants who had completed a core phase 2/3 glimepiride (SYR-322/CCT-005; NCT01318083) or metformin (SYR-322/CCT-006; NCT01318109) add-on study were enrolled in one of four, once daily (QD) or twice-daily (BID) treatment groups. Five participants completed OCT-005 study without receiving the study drug.
737431|NCT01318122|Participants enrolled at 32 investigative sites in Japan from 10 May 2008 to 03 August 2009.|Participants who had completed the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070) were enrolled in one of 2, once-daily (QD) treatment groups.
737432|NCT01318109|Participants enrolled at 30 investigative sites in Japan from 22 August 2008 to 28 April 2009.|Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite treatment with metformin as well as diet and exercise were enrolled in one of 3, once-daily (QD), twice daily (BID) or three times daily (TID) treatment groups.
737433|NCT01318083|Participants enrolled at 33 investigative sites in Japan from 20 August 2008 to 18 April 2009.|Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite treatment with sulfonylurea as well as diet and exercise therapies were enrolled in one of 3, once-daily (QD) or twice daily (BID) treatment groups.
737434|NCT01318070|Participants enrolled at 33 investigative sites in Japan from 22 November 2007 to 22 October 2008.|Participants with historical diagnosis of type 2 diabetes with uncontrolled blood glucose despite treatment with pioglitazone as well as diet and exercise therapies were enrolled in one of 3, once-daily (QD) treatment groups.
737435|NCT01318018||
737436|NCT01317940||Group A: 2 participants enrolled but did not reach time of randomization (1 induction death, 1 severe toxicity/change in treatment plan) Group B: 2 subjects enrolled but did not reach time of randomization or undergo any study procedures (2 lost to follow-up)
737437|NCT01317901|Twelve adult patients, 6 in each dose group, were enrolled at 4 hospitals between May and October 2011.|
737438|NCT01317797|Participants took part in the study at 10 investigative sites in Bulgaria, Netherlands and Spain from 09 March 2011 to 08 August 2013.|Participants with a diagnosis of mild or moderate rheumatoid arthritis were enrolled into 1 of 3 treatment groups namilumab (MT203) 150mg, namilumab 300 mg or placebo.
737439|NCT01317667||
737440|NCT01317641|Participants were enrolled at 23 hospitals in Europe and in the USA from Apr 5, 2011 to Mar 12, 2013|136 participants participated in the study, including 24 enrolled in Phase 1 and 112 in Phase 2 randomly assigned to 200 mg, 400 mg or 1400 mg daily doses and stratified by previous chemotherapy and treatment with CYP17 inhibitor. Two participants assigned to treatment did not start ODM-201, and were therefore excluded from analyses populations.
737441|NCT01317615|This was an open-label, single arm study.|
737442|NCT01317550|Recruitment Period: July 15, 2011 to October 21, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.|
737443|NCT01317472||
737444|NCT01317199|"Recruitment dates:
~Phase I: October 4, 2011-August 7, 2012 in medical clinics Phase II: January 31, 2013-October 20, 2014"|"Enrolled subjects agreed to abstain from other commercially available Muscadine Plus products while in this trial.
~If subjects were taking other dietary/herbal supplements (e.g. saw palmetto, selenium, pomegranate juice or pills, etc) prior to study entry, they had to be on a stable dose for 2 months prior and not stop while on trial."
737445|NCT01317160||
737446|NCT01317095||
737447|NCT01317030||
737448|NCT01317004|Actual enrollment = 61 because 65 participants were randomized to the study, but only 61 participants received at least one dose of study medication. As such, the participant flow captures the 65 participants randomized and the 61 participants who received drug as the safety set.|
737449|NCT01316939|This study was conducted at 128 centers in 28 countries with sites in North America, Europe, Israel, South Africa, Japan, Republic of Korea, Hong Kong, Australia, and New Zealand from 09 May 2011 and 23 October 2013.|The study was planned to randomize approximately 756 participants (252 participants per group) from induction studies CCX114151 and CCX114643. However a total of 229 participants (159 who participated in study CCX114151 and 70 who participated in study CCX114643) were randomized and comprised the analysis population for this study.
737450|NCT01316926|Recruitment is conducted in accordance with internal Standard Operating Procedures of the research center and with the consent of the participants (Term of Recruitment and Informed Consent Form).|All candidates are informed about the study, and all undergo clinical screening.
737451|NCT01316913||Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 7- to10-day run-in period and were then randomized to a 24-week treatment period. A total of 1191 par. were screened; 872 par. were randomized and 869 par. entered the treatment period.
737452|NCT01316900||Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 7- to10-day run-in period and were then randomized to a 24-week treatment period. A total of 1141 par. were screened; 846 par. were randomized (3 par. were randomized [2 in error] and received no study drug) and 843 par. received at least one dose of study drug.
737453|NCT01316887||The study consisted of a Run-in Period of 7 to10 days, followed by a 52-week Treatment Period. A total of 893 participants were screened; of these, 312 were screen failures, 19 were Run-in failures, 563 were randomized, and 562 received at least one dose of study drug (one participant was randomized in error but did not receive study drug).
737454|NCT01316770|14 participants were screened in the United States. Nine of the participants were then eligible and enrolled between October, 2011 and Sep, 2013 and administered treatment.|Screening occurred in two stages: Stage I (within 6 weeks before Stage II), and Stage II (within 6 weeks before randomization). Ten participants were eligible following the Stage I screening, but one subject loss their eligibility at Stage II screening because she refused the parotid biopsy.
737455|NCT01316692|Participants on this study were treated at Vanderbilt-Ingram Cancer Center. The study was conducted from October 2011- August 2015|A total of 19 patients consented to participate in this study. Four of 19 patients were screen failures and therefore were not eligible, 3 patients were eligible, but withdrew before treatment.
737456|NCT01316614|The study opened to participant enrollment on 07/21/2010 and closed to participant enrollment on 02/07/2012.|
737457|NCT01316575|Recruitment began 4 April 2011 and ended 29 April 2012. The target enrollment was 40. 40 patients were enrolled in the study.|
737458|NCT01316510|Infants were eligible for the study if they had confirmed gastroschisis at birth and gestational age at birth > 34 weeks. Parents were approached prior to or after the birth. All infants enrolled were inpatients in the NICU at UC Davis Children's Hospital in Sacramento CA. Enrollment began in March 2011 and was completed in Feb 2015.|
737459|NCT01316419|This is an observational study to evaluate the effects of Twynsta tablets (Telmisartan and amlodipine fixed dose combination (FDC), once daily (q.d.)) with life style modifications on blood pressure, quality of life, and other risk factors in Korean patients with hypertension|
737460|NCT01316380||
737461|NCT01316341||
737462|NCT01316315||
737463|NCT01316302||
737464|NCT01316276|Study TR02-110 did not include any patients from Study TR02-109 since that study never enrolled patients.|
737465|NCT01316263||Participants who were considered to have completed Stage 1 of the study discontinued due to progressive disease (PD) or died.
737466|NCT01316224||
737467|NCT01316211||120 patients in the Coflex group and 126 in the control group underwent surgery. 4 Coflex patients and 3 Control patients had to be excluded from full-analysis population, since no follow-up values were recorded and the reason of drop-out did not indicate treatment failure.
737468|NCT01316055|First subject screened January, 2011. Last subject out August, 2011. Full Service Phase 1 Units.|
737469|NCT01316042||
737470|NCT01315873||
737471|NCT01315847||Due to protocol amendment study Part II was not conducted. One subject who started in Part I, Period 2 had not participated in Part I, Period 1. Therefore, the cumulative total number who started Part I (including those starting in Period 1 and 2) is 6. Study participants were included in either Part I or Part III; none were included in both parts.
737472|NCT01315678|302 participants were randomized. 8 were not treated.|
737473|NCT01315665||
737474|NCT01315574|Participants recruited from May 2011 to June 2013|
737475|NCT01315353|Participants were enrolled from April 2012 to June 2014 from 7 different countries.|
737476|NCT01315249|All eligible patients were randomized to one of the 2 arms in a 1:1 ratio for 26 weeks of treatment.|A total of 523 patients were randomized. A total of 522 patients (99.8%) were included in the Full analysis Set (FAS) and Safety set. One patient was excluded who was randomized in error and did not receive study medication.
737477|NCT01315236|One patient out of the 90 was randomized but not dosed.|
737478|NCT01315158||
737479|NCT01315145||
737480|NCT01315132||
737481|NCT01315028|Participants were consecutively recruited from mental health services within the Glasgow. A total of 32 patients were referred to the study during the 9-month recruitment window between November 2010 and July 2011 (3.5 referrals/month). Of the 32 patients referred 23 consented to participate in the trial. This equates to a consent rate of 71.88%.|Of the 32 individuals referred, 6 were not assessed as: 3 refused consent, 2 were unable to be contacted within recruitment window and 1 individual moved away from the study location. A further three individuals did not meet our inclusion criteria.
737482|NCT01315002||
737483|NCT01314963||
737484|NCT01314911|Participants with an influenza-like illness and diagnosed with influenza by rapid antigen or PCR were recruited at 42 sites from 3 countries: 3 from Argentina, 4 from Thailand and 35 from the U.S., between January 2012 to October 2017.|Seven hundred and sixteen subjects were enrolled per protocol (signed consent). Of these 716 subjects, three subjects were inadvertent enrollments, and one was a repeat enrollment of a subject who had been previously enrolled .One hundred fifty-four subjects were excluded during screening and did not participate in any other aspect of the trial.
737485|NCT01314872||This was a 2-Part, randomized, double blind placebo- and active-controlled, parallel-group study of vibegron in men and women with Overactive Bladder (OAB). Participants who enrolled in Part 1 were not eligible to participate in Part 2. Participants who completed Part 1 or Part 2 were eligible to enroll in an optional 1-year safety extension.
737486|NCT01314742|Of the 82 mechanically ventilated infants ≤ 28 weeks gestation who were screened, 46 met eligibility criteria. Of these eligible infants 41(89%) were recruited and randomized.|
737487|NCT01314716|Subjects were enrolled in a total of 90 study sites in the North America, Europe, and Australia. The first participant was screened on 25 April 2011. The last participant observation was on 01 July 2013.|404 participants were screened, 274 were randomized and comprise the Intent-to-Treat (ITT) Analysis Set. 272 randomized participants received at least one dose of study drug and comprise the Safety Analysis Set.
737488|NCT01314703|Recruitment period: March 05-April 04, 2011. Location: Microbiotest,clinical study center|35 subjects entered pre-screening phase.2 subjects withdrew consent prior to the Screen Visit.33 subjects completed screen baseline.3 subjects did not meet screen baseline criteria.30 subjects qualified for treatment.3 subjects were discontinued prior to treatment because the required number of treatment sites were met. 27 subjects were treated.
737489|NCT01314443|Recruitment took place in and around the community surrounding the University of Connecticut. Recruitment occurred from 2010-2011.|Health status of participants was determined from a comprehensive metabolic panel as well as circulating lipid levels. Individuals having serum chemistries outside of acceptable limits were not enrolled.
737490|NCT01314417||
737491|NCT01314313|Between December 23, 2011 to November 6, 2013 2,032 patients were enrolled into the PARTNER II A SAPIEN XT vs SAVR Intermediate Risk Trial at 57 sites in the United States and Canada.|
737492|NCT01314261||
737493|NCT01314118||
737494|NCT01314105||"Abbreviations Used:
~CTCAE: Common Terminology Criteria for Adverse Events
~ALT: Alanine Amino Transferase
~AST: Aspartate Aminotransferase
~ULN: Upper Limit of Normal"
737495|NCT01314014|Recruitment for this study occured at two academic medical centers (University of Rochester and Arizona Cancer Center) from June 7, 2011 through March 4, 2013.|
737496|NCT01314001|The trial was conducted at four academic medical centers. From 11/16/2010 to 9/16/2013, participants were recruited through advertisements for a free smoking cessation program.|"Subjects were randomly assigned to one of three treatment groups in a 1:1:1 ratio: Placebo; Nicotine Patch; or Varenicline. Randomization was stratified by nicotine metabolite ratio - slow metabolizers of nicotine vs. normal metabolizers - and study site and blocked in blocks of 12 to maintain balance. Slow metabolizers were over-sampled."
737497|NCT01313936||
737498|NCT01313923|three patients were screened and enrolled in the study.|"Only major consideration for the pre-assignment is to exclude any patient with underlying immunodeficiency or hematological disorder. Investigational product itself can suppress hematopoiesis and is an immuno-modulator.
~All three patients screened were enrolled in the study."
737499|NCT01313910|Patients with diagnosis of HIV enteropathy are eligible for enrollment.|
737500|NCT01313897||
737501|NCT01313884||
737502|NCT01313858||
737503|NCT01313780|ITT set(Safety analysis) was 128(64:64) patients, but Missing primary efficacy data: 7 patients, Violation of inclusion/exclusion criteria: 4. So, FAS(Efficacy analysis) set population was 117(oxycodone/naloxone group: 58: Oxycodone: 59).|
737504|NCT01313767|In this study, total 208 patients were screened and total 196 subjects (98 subjects per group) were randomized, except 12 screening-failures, at 5 study sites.|Total 9 subjects were prematurely discontinued from the study due to unmet inclusion/exclusion criteria found after randomization, AEs/SAEs, consent withdrawal and follow-up lost: 7 subjects in study group (7.14%) and 2 subjects in control group (2.04%). Thus total 187 subjects (91 in study group; 96 in control group) completed the study.
737505|NCT01313728||
737506|NCT01313689|Note: The 'Total Participants' in the Baseline Characteristics Table and in most of the Efficacy results Tables should be either Any OFA + Physician's Choice or OFA extended + OFA observation + OFA + Physician's Choice instead of the automatic calculated Total number indicated.|Participants(par) were randomized to receive an Open-Label treatment(trt) of ofatumumab(OFA) or a physicians choice(PC) trt for up to 24 weeks. OFA par without progressive disease(PD) underwent a second randomization to receive an additional 24 weeks of OFA or no further trt. PC par who developed PD had the option to receive OFA salvage therapy.
737507|NCT01313676|This study was conducted at 1373 sites. The study employed an event-driven design and was to conclude when approximately 1000 reports of a primary outcome event of death were received. The study consisted of a 4-10 day run-in period, variable treatment period until the required number of events was achieved, and 1 week follow-up period.|A total of 23,835 participants were screened, of whom 16,590 were randomized. Of the 16,590 participants randomized, 16,568 participants received a single dose of investigational product (IP) and were assigned to a treatment and included in the Safety Population.
737508|NCT01313663||Participants (par.) must have received at least 4-6 cycles of induction therapy with carboplatin + pemetrexed or cisplatin + pemetrexed and should have had stable disease, partial response, or complete response as best response at the time of screening/enrollment. Par. were stratified by disease stage and cycles of induction therapy at enrollment.
737509|NCT01313650||Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 7 to 10-day run-in period and were then randomized to a 24-week treatment (trt.) period. A total of 2210 participants were screened; 1536 participants were randomized and 1532 participants took at least one dose of randomized medication.
737510|NCT01313637||Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 7- to14-day run-in period and were then randomized to a 24-week treatment (trt.) period. A total of 2114 participants were screened; 1493 participants were randomized, and 1489 participants took at least one dose of randomized medication.
737511|NCT01313624|Subjects were enrolled in a total of 57 study sites in the United States, Canada, and Australia. The first participant was screened on 25 April 2011. The last participant observation was on 04 June 2013.|348 participants were screened and 266 were randomized and treated, and comprise the Safety Analysis Set and the Intent-to-Treat (ITT) Analysis Set.
737512|NCT01313559||
737513|NCT01313520||
737514|NCT01313507||
737515|NCT01313494|Participants took part in the study at 43 investigative sites in mainland China, Hong Kong and Singapore from 04 Mar 2011 to 16 May 2012.|Participants with a diagnosis of chronic obstructive pulmonary disease (COPD) were randomized in 1 of 2 treatment groups (placebo and roflumilast 500 μg once daily).
737516|NCT01313416||
737517|NCT01313312|The study was designed as a multicentre study and included a total of 34 investigational sites in Belgium, the Czech Republic, France, Hungary, Italy, Poland, Russia, Slovakia and the United States of America (US) that included at least one subject. This study was an open label extension to the double blind Study 145 (Y-52-52120-145).|Of 227 subjects who completed Study 145, 4 subjects entered an observational phase and never received treatment with Dysport® in this open label extension study (Study 148). The remaining 223 subjects were eligible for retreatment and progressed to Study 148. In addition, 31 of the 34 de novo subjects screened were included in this study.
737520|NCT01313273|Subjects ≥18 years meeting inclusion criteria were recruited for this study.|Investigators screened 8 subjects. Randomised 3 subjects and 5 were not randomised.
737521|NCT01313221|First patient enrollment :29 April 2011; last patient enrollment: 4 June 2012.|A total of 414 patients were screened,310 patients were enrolled and 287 randomized in this study; 144 in the etanercept monotherapy group (group A) and 143 in the etanercept plus an as-needed topical agent group (group B). 23 patients were not randomized because they did not complete the 12-week open-label treatment period before randomization.
737522|NCT01313208|First patient enrolled on 31 March 2011; Last patient enrolled 29 November 2012|
737523|NCT01313182||Only patients receiving surgery were considered Started.
737524|NCT01313117||
737525|NCT01313078||
737526|NCT01313039||
737527|NCT01312961|The study was conducted at 50 sites in the United States. A total of 491 participants were screened between March 2011 and June 2012, of whom 104 were randomized at 28 sites. A total of 387 participants were screen failures mainly due to inclusion criteria for eosinophilic asthma not met.|Randomization was stratified according to prior inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) combination therapy dose. Assignment to arms was done centrally using Interactive Voice Response System in 1:1 ratio to receive either Dupilumab 300 mg or Placebo.
737528|NCT01312948|Participants were recruited from Mater Children's Hospital patient database. Patients were recruited from January - April 2011. Participants attended Mater Children's Hospital Sleep Unit to take part in the study|
737529|NCT01312909||This study consisted of 3 phases: Screening (3 weeks before first dose of study drug); treatment (from Week 2 to Week 12 after a 2-week titration) and non-treatment follow-up (Week 13 through Week 52).
737530|NCT01312844||
737531|NCT01312818||
737532|NCT01312805||
737533|NCT01312779||
737534|NCT01312766||
737535|NCT01312675||
737536|NCT01312519|Adult patients 18 years of age requiring bone marrow aspiration and biopsy as part of routine care were considered eligible for the study.|No pre-assisgnment details.
737537|NCT01312467|Between 2011 and 2013, 45 obese colorectal adenoma (CRA) patients were enrolled at three study sites: UC Irvine, Long Beach VAMC, and Kaiser Permanente, Sacramento).|
737538|NCT01312428||
737539|NCT01312272||
737540|NCT01312233||
737541|NCT01312181|Participants age > 18 with > 4 days of NIDU during the prior 30 days were recruited from large urban HIV primary care clinics between 2011 and 2014.|Of 533 individuals assessed, 240 patients were randomized to a treatment condition, and 224 were included in analyses of the results.
737542|NCT01312129|Participants recruited in Albuquerque, NM between March 2011 and August 2011.|23 participants were recruited; 10 excluded; 13 approved; 1 participant lost to follow-up; 12 participants completed protocol. Of the 12 participants who completed the protocol, each received both interventions: Sulfasalazine first, then placebo, as well as, Placebo first, then Sulfasalazine. Subjects were randomized to intervention order.
737543|NCT01312038|Recruitment began in March 2011 and was terminated in March 2013. Recruitment was done by advertisement in the community.|Ninety subjects (31 males, 59 females)were screened; 25 subjects entered the randomization phase.
737544|NCT01311895||
737545|NCT01311687|The study was conducted at 93 sites: 68 sites in Europe, 10 sites in Australia, 10 sites in Canada, 4 sites in Russia, and 1 site in the United States (US) from 18 March 2011 to 29 August 2017.|Participants were randomized in a 2:1 ratio. Treatment phase discontinuation occurred when a participant had confirmed progressive disease. Participants who did not progress but who were intolerant to treatment, or no longer wished to receive study treatment entered the progression-free survival (PFS) follow-up period until disease progression.
737546|NCT01311661||
737547|NCT01311648|Study Part A was conducted at multiple centers in 12 countries between 09-JUN-2011 (first participant first visit) and 02-JAN-2013 (last participant last visit); Study Part B was conducted at multiple centers in 15 countries between 19-SEP-2012 (first participant first visit) and 09-SEP-2019 (last participant last visit). Study extension phase is ongoing.|Overall, 58 participants were screened in Part A, of which 7 participants were screening failures and 51 participants received at least one dose of the study drug; 52 participants were screened in Part B, of which 9 participants were screening failures and 43 participants received at least one dose of the study drug.
737548|NCT01311557|Study participants were enrolled from 07 March 2011 to 19 May 2011 at 36 clinical centers in the United States.|A total of 1302 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
737549|NCT01311505||Out of 22 participants enrolled, only 21 participants were randomized since 1 participant withdrew from the study.
737550|NCT01311362||
737551|NCT01311102||
737552|NCT01311024||
737553|NCT01310868||Study entry was based on imaging that has been judged to have typical appearances of a primary glioblastoma multiforme (GBM). Patients would have neurosurgery and GBM would be confirmed peri/post-operatively. If not GBM patients OR wafers+ 5-ala not administered then remain in the trial for follow up but were not included in the final analysis.
737554|NCT01310855||Trial closed prematurely because cediranib manufacture was discontinued by AZ. Only 38 patients were recruited
737555|NCT01310803||
737556|NCT01310777|Subjects were recruited from 63 investigational centers in the Asia-Pacific region, the European Union, Latin America and Caribbean nations, and the United States.|Of the 771 enrolled, 211 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (560).
737557|NCT01310699||
737558|NCT01310582|Recuitment was done from May 2011 to May 2013 at the Drexel University College of Medicine/Hahnemann University Hospital, there is a subspecialty practice of urologic surgery and pelvic floor repairs in elderly females.|Participant enrollment performed during the subject's pre admission testing at Hahnemann Hospital. Consented subjects were approched again on the morning of their surgery and group assignment was done. No other events prior to randomization, which was determined by computer generated randomization.
737805|NCT01296646|Recruitment occured primarily via community advertising by radio.|Subjects were screened and, if met criteria, randomized to placebo or naltrexone generally within 5-10 days.
737559|NCT01310413|The study included a first 385-days Blinded Phase (all subjects), followed by a 385-days Unblinded Phase. In this phase, subjects who received the placebo in the Blinded Phase were offered, after completing the Blinded Phase, 2 doses of Influenza A (H5N1) Virus monovalent vaccine administered for Dose 1 within a short delay of Day 385 (Day U0).|A total of 842 subjects were enrolled in the study in its Blinded Phase part. This number was later amended down to 838, following corrections for wrong subject number allocation and randomization errors.
737560|NCT01310400||
737561|NCT01310179||
737562|NCT01310127|Clinical outcomes of bromfenac ophthalmic solution 0.09% QD and nepafenac 0.1% ophthalmic suspension TID post cataract surgery with posterior chamber intraocular lens implantation, specifically looking at any differences in Early Treatment Diabetic Retinopathy Study visual acuities, macular volume, and/or retinal thickness changes.|Subjects were randomized to receive bromfenac(n=12) QD or nepafenac(n=11) TID. Dosing was 3 days before cataract surgery through day 21 postop. Subjects could not have used ocular/topical, systemic NSAIDs, gentamicin, or cyclosporine ophthalmic emulsion 7 days or prostaglandins 30 days prior to initial dosing of test article or during the study.
737563|NCT01310075|This study began enrollment on 04/15/2011 and was closed to enrollment on 12/08/2015. All recruitment done at the University of Texas MD Anderson Cancer Center.|
737564|NCT01310036||
737565|NCT01309997||
737566|NCT01309919||
737567|NCT01309906|A total of 66 participants (132 eyes) were enrolled in the study. One-half were randomized to receive the investigational lens, and the other half were randomized to receive the control lens. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.|
737568|NCT01309893|Participants recruited for this 2-week study conducted at three investigational sites in the USA. The first participant was enrolled on 12/17/2010; the last participant exited the study on 01/20/2011.|66 participants enrolled; 64 participants completed. Half wore Investigational Lens for 1 week then crossed over to Air Optix Aqua lens for 1 week. The other half wore Air Optix Aqua Lens for 1 week then crossed over to Investigational Lens for 1 week. The order of lens use was randomized and participant-masked.
737569|NCT01309880|This study was a randomized, bilateral, subject-masked, two-week study with a crossover at one week, conducted at three sites in the United States (US). First participant was enrolled on 12/01/2010, last participant exited the study on 12/23/2010.|A total of 66 participants (132 eyes) were enrolled in the study. One-half (33) were randomized to receive the investigational RD2117-01 ID4 contact lens first, and the other half (33) was randomized to receive the Air Optix Aqua contact lens first then crossed over after 1 week. All participants completed the study.
737570|NCT01309867|A total of 151 participants (302 eyes) were randomized to receive test contact lenses and 151 participants (302 eyes) were randomized to receive control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.|
737571|NCT01309841|This multicenter study was conducted in Australia, Germany, Slovakia, and the United States between 14 March 2011 and 16 August 2012.|The study duration was up to 18 weeks, consisting of an initial screening period lasting up to 2 weeks, a 2-week OIC confirmation period, during which the diagnosis of OIC and stability of the opioid regimen were confirmed, a 12-week treatment period, and a follow-up visit 2 weeks after the last dose of study drug.
737572|NCT01309828|Participants took part in the study at 46 investigative sites in the United States, Germany, Latvia, Lithuania, Poland, Slovakia, and the Ukraine from 02 March 2011 to 11 October 2012.|Participants with high blood pressure and moderate renal impairment were enrolled in 1 of 2 once-daily (QD) treatment groups.
737573|NCT01309802||
737574|NCT01309737||Outcome measures reporting results up to Week 16 consist of single placebo arm as reporting group while outcome measures reporting results up to Week 52 consist of 2 separate arms (for participants re-randomized at Week 16 to receive CP-690,550 5 milligram [mg] or 10 mg).
737575|NCT01309672||
737576|NCT01309659||
737577|NCT01309646||Initially, a total of 454 subjects were enrolled in the study but 3 subjects had withdrawn from the study. Therefore, a total of 451 subjects were enrolled in the study.
737578|NCT01309581||
737579|NCT01309451|The study was conducted at a single center. The sample size was 40 eyes (30 subjects, 10 subjects had both eyes in study)|Subjects were randomly assigned to either bevacizumab alone or bevacizumab plus Ozurdex in a 1:1 ratio. When both eyes were eligible, the right eye was randomized and the left eye was assigned to the other group. We had a total of 30 subjects, 10 with both eyes. 19 eyes were in the Bevacizumab Alone group and 21 eyes were in the Combined Group.
737580|NCT01309386||
737581|NCT01309360|Provision of information and inclusion in the study was done in the anesthesia outpatients clinic as part of the standard preoperative preparation.|Outpatients were prematurely dropped out for medical or non-medical reasons. Non-medical reasons:1.recall of the approval by the patient, 2.unavailability of the ultrasound-machine, 3.the planned operation was not carried out. Medical reasons: severe complications like systemic toxicity of the local anesthetic (seizure, cardiac arrest).
737582|NCT01309308|february-March 2011- department of obstetrics and gynecology|The participants are excluded from the study after assignment to the groups if they did not attend the second ultrasound measurement or if they delivered in another clinic.
737583|NCT01309282|A total of 9 participants were enrolled in one center from Portugal between 01 Jul 2010 and 30 Jun 2011. The first participant's screening visit was on 01 Jul 2010 and the last participant's last visit was on 19 Aug 2013. Although it was initially planned to involve two centers, it was only possible to involve a single center.|
737584|NCT01309269||In this non-interventional study, physician was completely free in his/her decision which participants he/she treated with the medication selected in this study, what dosage was chosen, which diagnostic measures were taken, how the course of treatment was monitored and what accompanying or supplemental medications were prescribed.
737585|NCT01309243|Subjects were enrolled in a total of 121 study sites in North America, Europe, and Australia. The first participant was screened on 23 February 2011. The last participant observation was on 03 February 2014.|991 participants were screened.
737889|NCT01291498|One patient entered the study. Screening and informed consent was conducted on 19 April 2011 and treatment was conducted at the Churchill Hospital on 31 May 2011|The company manufacturing the device reviewed patient's images before confirming eligibility for treatment.
737586|NCT01309204|Subjects were recruited from 102 investigational centers in the Asia-Pacific region, Canada, Central and South America, Europe, and the United States.|Of the 1184 enrolled, 294 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. Of the 890 randomized, 2 subjects did not receive study medication. This reporting group includes all randomized subjects who received study medication (888), as treated.
737587|NCT01309165||
737588|NCT01309100|This was a randomized, bilateral, three-way crossover, subject-masked study conducted at six sites in the United States. The first participant was enrolled 11/8/2010 and last participant exited on 12/23/2010.|144 participants were equally randomized to one of six treatment sequences. 142 participants completed the study.
737589|NCT01308918|Between May 14th 2010 and January 17th 2011, 50 patients were enrolled in the study at the end of their pre-operative visit to the thoracic surgery department.|No enrolled participant were excluded from the study. All participants were included into the same group.
737590|NCT01308853||
737591|NCT01308840|38 participants were screened.|5 subjects were not eligible to enroll. 2 participants did not receive the intervention.
737592|NCT01308814||
737593|NCT01308788|recited over 6 months|
737594|NCT01308762|A total of 24 patients with melanoma entered the screening phase of this study between 10 March 2010 and 27 July 2010.|Five patients were found to be ineligible and failed screening. These patients were withdrawn before receiving study medication.
737595|NCT01308749||This study is a 2 sequence (arm) study with 2 periods - double-blind (0-8 weeks) and open label (8-16 weeks). The sequences are 1: oxytocin-oxytocin and 2: placebo-oxytocin. 1 participant from sequence 1 did not enter period 2 due to withdrawal due to adverse events.
737596|NCT01308736||"73 potential participants provided informed consent and were therefore Enrolled, however 10 of these did not meet all eligibility criteria as they were completing the baseline measures. We therefore Started 63 randomized participants as indicated in the Participant Flow module."
737597|NCT01308619|First subject enrolled 9 May 2011, last subject last visit 2 July 2012|
737598|NCT01308580|The study was conducted at 172 centers in 22 countries. A total of 1463 participants were screened between 19 April 2011 and 18 November 2013. Out of 1463 participants, 1200 participants were enrolled in this study and 263 were not eligible to join the study.|Participants were randomized by Interactive Voice Response System (IVRS) in 1:1 ratio (Cabazitaxel 20 mg/m^2: Cabazitaxel 25 mg/m^2) and stratified according to Eastern Cooperative Oncology Group Performance Status (ECOG PS) score (0 or 1 versus 2), measurability of disease (measurable versus non-measurable) and region.
737599|NCT01308567|The study was conducted at 159 centers in 25 countries. A total of 1510 participants were screened between 17 May 2011 and 09 September 2015 of whom 1168 participants were randomized and 342 were considered as screen failures.|"A total of 1168 participants randomized in this study. Of these, 21 participants randomized but not treated. These participants were included in intent-to-treat (ITT) population, not in safety population. Study cut-off date for outcome measures was up to primary completion date (PCD) only. After PCD, only adverse event (AE) data was updated."
737600|NCT01308476|Patients who participated in this study had to have access to a mobile phone since a SMS (short message service) / IVR (interactive voice response) system was used to remind to medication intake and to evaluate the adherence to Spiriva HandiHaler.|Non-interventional controlled pilot study with two parallel groups.
737601|NCT01308463|Recruitment has been discontinued.|
737602|NCT01308450|302 subjects meeting enrollment criteria were recruited for this study from a database of patients from a single site, The Focus Center. 300 subjects were eligible to participated and signed Informed Consent.|"This one visit, one site study was conducted to enhance and extend the current normative database of the adolescent and adult version of the Quotient ADHD System, an FDA cleared medical device. The study enrolled both male and females, between the ages of 15 and 55 (to match the current database)who were considered normal, non-ADHD subjects."
737603|NCT01308424|Participants were recruited from four dental clinics in the USA during the study period of 1/26/11 - 9/14/2012|Participants entered a baseline run in period to assess eligibility before randomization and dental procedure.
737604|NCT01308294|16 patients were selected between June 15, 2010 and January 24, 2013. Among them 10 patients were included in the group 1 and 6 in the group 2. Since January 2013, 11 patients have been prescreened but could not be included in the study. On April 15, 2014, the decision had to taken to abort the study (16 patients included, while 28 were planned).|"An unexplained high percentage, i.e. about 90% of the 11 prescreened patients were HLA-A2 negative. We assume that this was due to the increasing ethnic diversity of patients.
~The consequence of the time delay was that some of the peptides expired definitively."
737605|NCT01308060||
737606|NCT01308008|Participants were recruited in Ann Arbor, Michigan and surrounding communities. Recruitment relied primarily on media advertisement, community outreach and mailings to patients with diabetes treated at the Veterans Affairs Ann Arbor Healthcare System (VAAAHS) and the University of Michigan (UM), both of which provided IRB approval.|Withdrawal after Screening, prior to Baseline: N=5
737607|NCT01307956||
737608|NCT01307930||
737609|NCT01307891||
737610|NCT01307787|A Rheumatologist referred people diagnosed with RA to the rehabilitation department if they had complaints concerning their physical performance or if they experienced problems with the daily management of their illness. Referred participants were independent and living at home. They did not include residents of nursing homes.|A total of thirty-nine individuals were referred for this study. Thirty-four individuals returned a signed Informed Consent form and five decided not to participate for a variety of reasons.(Impairment due to trauma n = 1 Not able to follow the program n = 1 Personal reasons n = 3)
737611|NCT01307748|212 people potentially interested in the study were evaluated for eligibility between 2010 and 2012. The potential participants were referred by clinicians from the university sleep clinic or learned about the study from the IRB-approved study information posted around the university, or published on social media.|
737612|NCT01307631||
737613|NCT01307618||
737614|NCT01307579||
737615|NCT01307501||
737616|NCT01307462||
737617|NCT01307449||
737890|NCT01291277||
737891|NCT01291264|Recruitment dates were 06/06/12 to 09/19/12. Study was done at the San Francisco City STD Clinic.|
737618|NCT01307423|The study was conducted in 16 countries including the United States, Canada, Europe, New Zealand, Australia and Russia.|This study consisted of a 24-week randomized, double-blind, placebo-controlled phase, a 28-week randomized, double-blind active treatment phase and a 4-year open-label safety phase, for an overall study duration of 5 years.
737619|NCT01307397||
737620|NCT01307319||A total of 1026 subjects were screened and 906 were enrolled and participated in the Run-in Period. Of the 906 enrolled subjects, 715 were randomized to treatment.
737621|NCT01307267||There was 1 participant who was enrolled but withdrew the consent before starting any of the treatment arms; therefore, this participant was not included in the participant flow table.
737622|NCT01307111|The study design is double-blind randomized controlled trial in which nulliparous women requesting an IUD were randomized to 400 mcg of buccal misoprostol or placebo 2-8 hours before insertion.|3 of the 85 enrolled participants were deemed ineligible and not randomized to misoprostol or the placebo group.
737623|NCT01307098||Participants were screened for eligibility for enrollment in this study (LAL-CL01). Nine participants met all enrollment criteria and were enrolled and allocated to 1 of 3 cohorts.
737624|NCT01307046||
737625|NCT01307033||
737626|NCT01307020|First patient in (screening) 23 Feb 2011, last patient out 14 Oct 2011. At 16 study centres in 6 European countries (Germany, Italy, Hungary, Poland, Spain and United Kingdom).|The trial encompassed 3 visits: 1-Screening; 2-Dental surgery (patients who have moderate to severe pain afterwards were randomised and received study drug); 3-End of study. Overall, 745 patients were enrolled (screened), of them 611 were randomized to receive the study drug and therefore considered as started.
737627|NCT01307007|Hospitals and medical clinics|In the FCM group, reasons for discontinuation prior to dosing included lost to follow-up (5 subjects), subject request (2 subjects), and selection criteria/study compliance (2 subjects). In the iron dextran group, reasons for discontinuation prior to dosing included subject request (4 subjects) and lost to follow-up (1 subject).
737628|NCT01306968||
737629|NCT01306942|Ten patients were enrolled at the phase I receiving at least one cycle of the combination. Six patients were included at Dose Level (DL) 1 and four patients at DL 2. One patient at DL 1 and two patients at DL 2 had a DLT. Twenty-seven patients were included at the phase II.|
737630|NCT01306890||
737631|NCT01306877||
737632|NCT01306656||
737633|NCT01306643|Participants were enrolled at 2 study sites in the United States. The first participant was screened on 22 February 2011. The last study visit occurred on 24 August 2015.|24 participants were screened.
737634|NCT01306617||
737635|NCT01306331|Healthy, sexually active women at risk of pregnancy who desired contraception, aged 18 to 35 years, with a single male sex partner, of which both partners were at low risk for HIV and sexually transmitted disease (STD) infection. Subjects were required to have regular, normal, cyclic menses with a usual length of 21 to 40 days.|The study had 65 randomized screen failures and were not included in the ITT population due to being accidentally randomized (30 randomized to Amphora™ Gel and 35 to Conceptrol®).
737636|NCT01306305|Participants were recruited at one center in Switzerland First subject first visit (FSFV): 28-Jun-2010 Last subject last visit (LSLV): 20-Jul-2010|
737637|NCT01306292||
737638|NCT01306253|Participants were recruited at one center in Switzerland First subject first visit (FSFV): 05-Jun-2009 Last subject last visit (LSLV): 30-Jun-2009|
737639|NCT01306214||
737640|NCT01306201|Recruitment dates were February 10, 2011- to March 4th,2011|
737641|NCT01306175||
737642|NCT01306162||In this crossover study, subjects were randomly assigned to one of the 4 sequences, but with 5 treatments. In general terms ABDE,ACED,BDEA,CEDA. There were four subjects in Trt E who took Dronedarone mistakenly in place of Dabigatran. These are presented separately for adverse events.
737643|NCT01306058||27 patients were enrolled. One patient signed consent but developed rapid disease progression and did not receive any treatment.
737644|NCT01306032||Triple-negative breast cancer participants were enrolled but three did not start the study (two withdrew, 1 progressed).
737645|NCT01305941|Subjects were recruited from 4 institutions between September, 2011 and May, 2016.|A total of 41 patients were consented to this study. Of these, 6 patients were found ineligible, 2 withdrew prior to treatment, and 1 patient has disease progression prior to protocol therapy. Therefore only 32 patients were enrolled and participated in the trial.
737646|NCT01305811||
737647|NCT01305772||All patients had successful genomic screening and RNA extraction/quality control.
737648|NCT01305655|From July 2008 children treated with the NOPHO ALL 2008 protocol (1-18 years) in the Nordic- and Baltic countries received Glucarpidase if they had delayed Mtx elimination in connection HDMTX 5 g/sqr at predefined values.|
737649|NCT01305577|This study was conducted in 28 study centers in the European Union.|The study consisted of a 12-week treatment period and a 12-week safety follow-up period.
737650|NCT01305564||
737651|NCT01305473|Between October 2010 and February 2011, a total of 90 subjects were enrolled at a single study site.|
737652|NCT01305408|Region 1: USA and Canada Region 2: Eastern European countries, Kyrgyzstan, Mongolia, Uzbekistan, Cyprus, Greece, and Turkey Region 3: Central and Northern European countries, Andorra, Australia, Iceland, Monaco, San Marino, and Vatican City Region 4: Rest of World|Participants were randomized (1:1) to receive150 mg/day armodafinil or matching placebo. Randomization was stratified on the basis of the mood-stabilizing medication and region of the world.
737653|NCT01305356||A propensity score matching analysis was performed in order to identify a single set of investigational and control subjects derived from the datasets (BMTI-2006-01, BMTI-2009-01, BMTI-2010-01) that were comparable and could be evaluated for the purpose of assessing the safety and effectiveness of AUGMENT® Injectable.
737654|NCT01305265||
737655|NCT01305252||
737656|NCT01305239||
737657|NCT01305213|The study was activated on 3/21/2011 and closed on 4/22/2013|
737658|NCT01305200||
737806|NCT01296568||Study had 2 phases. First phase: participants (pts) received single dose of carbon-14-labeled LY2603618 ([^14C]LY2603618) and completed a minimum 7-day washout. Second phase: pts had option to continue receiving LY2603618 in combination with gemcitabine or pemetrexed. All pts chose to receive gemcitabine for combination treatment.
737659|NCT01305044|371 female cancer survivors with some functional limitations were recruited through Huntsman Cancer Institute registries and clinics, and community advertisements (media, newspapers). The first cohort of participants was held in the Spring 2010 with the second and third cohorts of participants held in the Fall 2010 and Spring 2011, respectively.|Forty percent (n=150) expressed an interest in participating and 42% who met eligibility (n=63) were randomized to receive 12-week (3 days/week) of TCC or Health Education Control (HEC) classes.
737660|NCT01304966|Date of the recruitment is APril 2011.Number participants staring is fifteen.|
737661|NCT01304940||
737662|NCT01304706||
737663|NCT01304693|Subjects were recruited from 51 investigational centers located in the United States, Europe, Israel, and Australia.|Of the 376 enrolled, 182 were exited as screen failures prior to exposure to randomization and exposure to the study drug. This reporting group includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (ITT) (194).
737664|NCT01304641||
737665|NCT01304589||
737666|NCT01304498|A total of 603 participants were screened and 600 were randomized|
737667|NCT01304407|The isotope tracer is used as a method to evaluate calcium absorption.|
737668|NCT01304329||This was a randomised, open label, 3 period crossover study. Treatment periods were separated by a washout period of at least 7 days.
737669|NCT01304316||
737670|NCT01304277|The first patient participated in the study on 06 December 2011 and the last patient completed the study procedures on 28 December 2012.|
737671|NCT01304238||
737672|NCT01304147|Study participants were recruited from physician referrals, media advertisements, and an academic outpatient psychiatric clinic. All study treatments were performed at Mount Sinai Medical Center between April 2012 and June 2013.|
737673|NCT01304082||
737674|NCT01303965|This protocol was a Phase I/II study. Phase I was based on a 3+3 design with the first cohort found to be safe with 3 patients. Phase II was based on a Simon Minimax two-stage design with the first interim analysis planned after 28 patients. The study was stopped at 11 patients in Phase II due to slow accrual.|
737675|NCT01303939|22 glaucoma patients were enrolled in this study. However, 7 age, gender and ethnic matched controls were not found for study comparisons. Therefore, only the 15 glaucoma patients who best matched the controls were included in the published analysis.|
737676|NCT01303861|Recruitment began on 3/07/11 and ended on 11/30/12. Of the 702 subjects consented during this period, 218 were in our Charlotte, NC office, 157 were in our Durham, NC office, 151 were in our Raleigh, NC office and 176 were in our Winston-Salem, NC office. Only 349 subjects met all study criteria, and 22 discontinued prior to being assigned.|
737677|NCT01303835||Patients were randomized to either low dose naltrexone (LDN) or placebo and were followed for 24 weeks. A patient is defined as completing the study if they completed the Quality of Life (QoL) assessments at 24 weeks.
737678|NCT01303744||
737679|NCT01303627||
737680|NCT01303510|Participants were recruited at one center in Switzerland FSFV: 09-Jul-2008 LSLV: 30-Jul-2008|
737681|NCT01303445||
737682|NCT01303419|Women 21 years of age or older, with newly diagnosed cancer identified through through core biopsy or fine-needle aspiration (FNA) within the last 30 days and with a bilateral CE-BMRI performed within 30 days of the new breast cancer diagnosis.|
737683|NCT01303406||
737684|NCT01303380|The study was conducted at 3 centres in Spain.|A total of 10 participants were screened, 9 of which entered in the treatment period of the study, one participant was considered to be a screening failure.
737685|NCT01303224|First subject screened 06/10/2010, first subject randomised 22/10/2010, last subject out 11/05/2012, at 78 study sites in 8 European countries (Bulgaria, Czech Republic, Denmark, Germany, Italy, Poland, Spain, and Sweden)|A run-in period was planned to confirm eligibility criteria. 5 more patients were randomized instead of the planned number (560) because due to the high screen fail rate it was impossible to predict with how many patients the enrollment goal would be reached. Although the enrollment goal was reached these 5 patients in screening continued the study
737686|NCT01303159||
737687|NCT01303003||No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.
737688|NCT01302964||
737689|NCT01302938||Out of 237 participants screened, 118 participants received single-blind placebo matched to tolterodine 4 milligram (mg) capsule once daily during run-in period for 2 weeks. Only 18 participants were randomized to receive double-blind treatment due to early termination of the study.
737690|NCT01302899||
737691|NCT01302860|The study was conducted at 14 centers in 7 countries.|A total of 17 participants were enrolled into the study.
737692|NCT01302834||Sites were required to submit participant tumor tissue for central p16 evaluation within one week of registration. If participants were determined to be p16-positive and continued on the study, then treatment arm was assigned. Of 987 participants registered, 849 were randomized.
737693|NCT01302743||
737694|NCT01302691||All participants received single-blind losartan 50 mg (L50) + amlodipine 5 mg (A5) and placebo for L50/(H12.5)/A5 during 8-week Filter/Screening Period. A total of 707 entered the Filter/Screening Period and 327 were randomly assigned to 1 of the 2 treatment arms for the Double-blind Treatment Period.
737695|NCT01302548||
737696|NCT01302483|Recruitment completed within the month of December, 2008. Subjects were primarily recruited from University of Buffalo staff and students.|
737697|NCT01302444||
737698|NCT01302418||
737699|NCT01302392|Subjects were enrolled from 06 Sep 2010 to 21OCT2012. Results are reported as of the data cut-off date of 10 Jul 2014.|
737700|NCT01302379||
737701|NCT01302366|From March 2011 to October 2012, 20 patients were enrolled to the study from Perlmutter Cancer Center at NYU Lagone Medical Center.|
737807|NCT01296542||
737808|NCT01296412||
737809|NCT01296360||
737810|NCT01296347||
737811|NCT01296191||
737892|NCT01291225||
737702|NCT01302119|Subjects were screened and enrolled at forty-two investigative centers in the United States and Canada. The study population included men and women, 18 years of age and older who had distal subungual onychomycosis. The first subject visit occurred on February 2, 2011, and the last subject completed the Post Study Follow Up on February 20, 2013.|Eligible subjects were randomized in a 2:1 ratio to receive AN2690 Topical Solution, 5% or Solution Vehicle to be applied once daily to all affected toenails throughout the 48-week treatment period.
737703|NCT01302067|This report presents results of a 12-week study conducted at 241 centers across 27 countries.|Participants ≥18 years of age with overactive bladder (OAB) symptoms for ≥6 months prior to screening were enrolled. After screening eligible participants were enrolled into the run-in period and received placebo for 2 weeks in a single-blind manner. Participants completed a 3-day bladder diary for 3 days in the week prior to randomization.
737704|NCT01302054||
737705|NCT01302041|This was a multinational, phase 2, open-label, single-arm, efficacy and safety study of oral enzalutamide in participants with prostate cancer who had noncastrate levels of testosterone at study entry.|Eighty-two participants were assessed for participation in the study, 15 were excluded and 67 were enrolled. Participants who continued to receive clinical benefit as assessed by the investigator and did not meet any treatment discontinuation criteria were eligible to transition to an open-label extension study 9785-CL-0123 (NCT02960022).
737706|NCT01301963||
737707|NCT01301950||
737708|NCT01301833||
737709|NCT01301742||
737710|NCT01301729||A total of 32 participants were enrolled in the study and received study treatment.
737711|NCT01301625|Seventy eight (78) patients who met trial enrollment criteria were enrolled at 6 investigational sites throughout Australia and New Zealand. Enrollment period was November 24, 2011 to June 15, 2014.|
737712|NCT01301508||
737713|NCT01301456||Data for reporting arm Placebo 1a and 1b in stage 1 was planned to be pooled during analysis, as per protocol. Study consisted of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately.
737714|NCT01301391|Subjects were enrolled from 02 Feb 2011 to 28 Jan 2016 by 2 centers in US and one in Italy.|Four patients were screening failure.
737715|NCT01301274|Intensive Care Unit without cardiovascular patients, since 01/02/2011 until 01/11/2011|251 admitted patients to ICU, 97 eligible patients, 9 patients did not give consent, 22 were not randomized by treatment physician
737716|NCT01301092||
737717|NCT01301079|Inclusion criteria were: ≥18 years of age, any gender, classified as American Society of Anesthesiologists (ASA) Physical Status I or II, and undergoing laparoscopic cholecystectomy at Hospital São Paulo/Federal University of São Paulo, from September 2010 to September 2012.|
737718|NCT01301066||
737719|NCT01301027||
737720|NCT01301001|Participants were recruited between August 8, 2012 and January 19, 2016 from three academic centers.|230 women were screened, 89 met entry criteria and 66 completed the trial. Of the 141 patients who were excluded prior to randomization, 16 decided not to participate in the trial,101 did not meet inclusion criteria, and 24 did not return for randomization.
737721|NCT01300949||
737722|NCT01300923||The psychophysiological measures proved non-feasible as subjects could not tolerate the procedures. The paradigms were tried on two subjects in the Autism Spectrum Disorder arm; however, the data that was collected was not usable. Subsequently, neurobiological characterization was halted.
737723|NCT01300819|"The study was conducted in 71 sites spread across 12 countries, with 349 subjects randomized. The study duration per subject was up to 29 weeks.
~The Participant Flow consists of patients in the Enrolled Set (ES). The Enrolled Set (ES) includes all subjects who signed the Informed Consent Form."|Eligibility was assessed during the Screening Period, which lasted up to 4 weeks prior to the Baseline Visit. Eligible subjects returned for a Baseline Visit, during which all Baseline assessments were performed and then the subject was randomized to either Rotigotine or Placebo.
737724|NCT01300767|Participants were recruited from 5 US study centers.|• One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not in the Participant Flow or Baseline Characteristics calculations.
737725|NCT01300741|Participants were recruited from 5 US study centers.|
737726|NCT01300728||Fifty-two participants were randomized; however, 2 participants in the IVIG group did not complete the series of 5 infusions, and 1 placebo participant was excluded due to significant language symptoms which were a barrier to cognitive testing. This resulted having a data set consisting of a total of 49 subjects.
737727|NCT01300650|11 patients had elevated hsCRP (>2 mg/L) and were enrolled in the study.|2 patients withdrew consent prior to beginning the study. 1 patient underwent a change in heart failure medication prior to beginning the study and was therefore withdrawn from the study. The 8 remaining patients began the study interventions.
737728|NCT01300624||
737729|NCT01300572|This protocol is open to participants age 18 and above, of either gender and any race/ethnicity. The study is looking at the use of Y-90-DOTA-BC8 in conjunction with a standard reduced-intensity transplant regimen.|
737730|NCT01300559|60 adult patients (age ≥ 18 years) undergoing elective, multilevel, posterior lumbar decompression and fusion with Dr William Richardson were randomly assigned into two groups.|Enrollment started 10/09/2006 and enrollment completed 09/13/2010 with a total of 60 eligible subjects.
737731|NCT01300546|Recruitment period was from date of Institutional Review Board (IRB) approval (11-30-10) until date last patient enrolled (1/3/12). Subjects were recruited from general population at two clinical research centers.|Subjects must complete a 30 day Baseline Period between Visit 1 and Visit 2 before Randomization. Subjects must have had 6-14 headache days during the 30 day Baseline Period in order to be Randomized into the Study Treatment Period. Fifty nine subjects were screened for study; however, only 39 subjects randomized for treatment due to screen fail.
737732|NCT01300455||
737843|NCT01294397|This study was conducted at 2 centers in the United States. The first participant enrolled on 07 March 2011; the last participant was enrolled on 15 June 2015.|Following determination of eligibility at screening, 19 participants were enrolled into a 4-week run-in period of etanercept 50 mg subcutaneous once-weekly injection to ensure steady-state.
737844|NCT01294384||
737845|NCT01294371||
737733|NCT01300351|The planned population size was 220 randomised patients. 249 patients were enrolled with 28 screen-failured patients and altogether 221 patients were randomised. The recuitment period of this study took 34 months, first subject in on 01 Mar 2011 and last subject in on 23 Dec 2013.|The Enrollment number in the protocol section means the number of patients enter the trial and receiving screening procedure, the number of participants Started in the Participant Flow module means the number of randomized patients and do not include screening failure patients.
737734|NCT01300338|Participants were recruited and enrolled at the Mayo Clinic in Rochester, Minnesota from March 2011 to October 2012.|
737735|NCT01300286||
737736|NCT01300260||
737737|NCT01300247||
737738|NCT01300234|This was a 2 sequential treatment period study. In first period (double-blinded),participants received tenofovir disoproxil fumarate (TDF) 300 milligram (mg) once daily (QD) or adefovir dipivoxil (ADV) 10 mg QD for 48 Weeks. In second period (open-label single treatment), participants received TDF 300 mg QD for additional 192 Weeks.|969 participants were screened, 512 were randomized and 509 were treated with at least one dose of study medication in the double-blind treatment period. Participants who received at least one dose of study medication continued in open-label period.
737739|NCT01300065|There were 441 participants (882 eyes) enrolled, 221 in the test group and 220 in the control group. There were 434 eligible participants (868 eyes) who participated in the study, 216 in the test group and 218 in the control group.|
737740|NCT01300052||
737741|NCT01299961|A total of 34 RA patients were recruited from the UCLA rheumatology clinics between September 2011 to February 2013. However, we had a total of 9 screen fails.|Patients enrolled in the study were required to have RA, on stable RA medications, and naive to abatacept.
737742|NCT01299909||
737743|NCT01299896||
737744|NCT01299805|Participants took part in the study at one investigative site in the United States from 14 March 2011 to 11 June 2011.|In this study, 17 healthy men were enrolled and randomized to receive an oral dose of vortioxetine 20 mg or placebo in a 2:1 ratio.
737745|NCT01299766|Enrollment from June 21, 2011 to October 3, 2014; follow-up ended December 13, 2016. Potential participants were recruited when they sought memory screening at senior centers, senior housing sites, churches, and primary care clinics in Philadelphia, PA.|Prior to randomization, participants were administered neuropsychological tests to determine whether they met criteria for MCI. Participants with normal cognition and those with suspected dementia were excluded.
737746|NCT01299727|The study was conducted at 2 study centers in the Netherlands and United Kingdom between 01 March 2011 (first participant first visit) and 12 April 2019 (last participant last visit).|A total of 12 participants were enrolled in this extension study (HGT-SAN-067 [NCT01299727]), with 4 participants included in each of the 3 dose groups. Out of them, 10 participants completed the treatment period of the study.
737747|NCT01299610|The study was conducted at one center in Germany between 13 December 2010 and 14 April 2011.|Twenty five participants were randomized and completed the study.
737748|NCT01299584|The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Ultiva in the real clinical setting after launch.|
737749|NCT01299571|The objective of this post-marketing surveillance (PMS) study was to assess the occurrence of adverse events reported after administration of Avodart in Korean benign prostatic hyperplasia (BPH) patients.|
737750|NCT01299480||A total of 1714 participants were enrolled in this study. Of these, 1 participant was not randomized but was vaccinated with Saline at Injection 1. This participant was included in safety population and not intent-to-treat population. Participant Flow includes only randomized intent to treat participants.
737751|NCT01299454|81 participants were screened; of these 45 participants were enrolled recruited at 3 study sites in the United States (US).|
737752|NCT01299389||
737753|NCT01299376||All participants received single-blind losartan 50 mg (L50)/hydrochlorothiazide 12.5 mg (H12.5) and placebo for L50/H12.5/amlodipine 5 mg (A5) during 8-week Filter Period. A total of 510 entered the Filter Period and 286 were randomly assigned to 1 of the 2 treatment arms for the Double-blind Treatment Period.
737754|NCT01299285||
737755|NCT01299272||All enrolled participants entered the Acute Open-label (OL) Period. At Week 8, if remission criteria were met, participants entered the Stabilization OL Period. At Week 20, if randomization criteria were met, participants entered the 24-week Double-blind Randomized Withdrawal Period. Those who discontinued early entered the Discontinuation Period.
737756|NCT01299116||This is a partially randomized patient preference trial. Twenty two participants did not contribute data for analysis because they did not start a contraceptive in one of the three groups. For more information see: Hubacher D et al., 2017. The total number going forward for analysis is 894.
737757|NCT01299103||
737758|NCT01299090||
737759|NCT01299077|This study was recruited at 10 centers in China during the period of 09-Jun-2010 to 28-Sept-2010 .|
737760|NCT01299038||
737761|NCT01299025||
737762|NCT01298921||After the enrollment of 4 participants in this study, the PI left Geisinger and the study was terminated. Geisinger does not have any details regarding which Arm/Group participants completed. Therefore, 0 was added as the enrollment for each group.
737763|NCT01298778|Participants were approached during the pre-anesthesia evaluation regarding their interest in the study. Once consent was signed, subjects completed their pre-surgery questionnaires. On the day of surgery, I/E criteria were re-reviewed for confirmed enrollment for study.A total of 74 were consented with 69 randomized, with 60 completing the study.|
737764|NCT01298765||
737765|NCT01298752||
737766|NCT01298700||
737767|NCT01298661|The recruitment occurred from February 2011 until July 2012. The COPD patients were those referred to pulmonary rehabilitation on Unidade Especial de Fisioterapia Respiratória and the health individuals were recruited by invitation using posters on the University region.|
737768|NCT01298648||
737769|NCT01298596||
737770|NCT01298570|224 participants were consented to the study from 39 institutions from 4/7/11 - 8/10/15.|30 participants were ineligible, 7 withdrew prior to beginning protocol therapy, 3 could not participate due to study closure, 2 were unable to participate for financial reasons, 1 did not provide a reason for non-participation; 181 patients were enrolled and went on treatment.
737771|NCT01298544|All eligible participants who completed a previous study, 0887X-101518 (NCT00488826), were invited to participate in this study, at a timepoint at least 3 years after their last vaccination in study 0887X-101518.|No vaccines administered during study. However, participants assessed according to the vaccine group they were assigned to in study 0887X-101518: 7-valent pneumococcal conjugate vaccine (7vPnC) alone (Group 1), 7vPnC given concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) (Group 2), or DTaP alone (Group 3).
737772|NCT01298531|Out of 128 screened participants, 90 were assigned to either double-blind etanercept (ETN) 50 mg to open-label ETN 50 mg or placebo to open-label ETN 50 mg group. Participants entered an escape arm at Week 4 visit if the total back pain or the BASDAI score increased >50% vs baseline or participants were with maximum tolerated NSAIDs.|Four participants who were randomized to receive placebo in the double-blind phase were withdrawn during this phase, and they did not enter the escape arm, so these four participants never received ETN.
737773|NCT01298518||
737774|NCT01298492|The study was conducted at 81 centers in Austria, Belgium, Canada, France, Germany, Japan, Netherlands, Norway, Poland, Republic of Korea, Serbia, Slovakia, South Africa, Spain and United States between 22 July 2011 (first participant first visit) and 27 July 2016 (last participant last visit).|A total of 268 participants (225 participants from Feeder Study A7281006 [NCT01276509] and 43 participants from Feeder Study A7281008 [NCT01387594]) were enrolled and overall 149 participants completed the study.
737775|NCT01298362|A total of 290 post-menopausal female patients with ER-positive early breast cancer (BC) entered the study between February 2011 and December 2012. All 12 participating centers are hospitals where members of the Hellenic Society of Breast Surgeons operate.|
737776|NCT01298323|From 25 February 2011 to 27 April 2012, 205 patients were randomized by 33 centers in global 20 countries.|217 patients were screened; 205 patients were randomized to treatment.
737777|NCT01298219|Recruitment period: 07 December 2010 to 16 November 2011 Recruitment sites: 91 U.S. investigative sites and 14 E.U. investigative sites|Safety evaluable population includes all subjects who were randomized and dosed. Intention to treat (ITT) population includes only those subjects who were dosed and provided at least one post-treatment efficacy assessment.
737778|NCT01298193|"The investigator registered all the selected patients before the start of the treatment.
~Once it was verified that the selection criteria were complied with, the investigator sent the previously completed randomization sheet by fax to Spanish Breast Cancer Research Group (GEICAM).
~Recruitment period: From May-2011 to 31-Jan-13."|
737779|NCT01298167||
737780|NCT01298141|This multicenter study was conducted at 12 sites in Canada between 10 Aug 2011 (first participant first visit) and 25 Sep 2017 (last participant last visit).|A total of 171 participants enrolled into cohort 1 (participants from Canadian Fabry Disease Initiative [CFDI]) and cohort 2 (participants who participated in study REP001a) and among them 167 participants received at least one full or partial dose of Replagal (agalsidase alfa) animal free (AF).
737781|NCT01298128||
737782|NCT01298063||
737783|NCT01297985|Recruitment was conducted collaboratively with the statewide consumer coalition, Tennessee Mental Health Consumer's Association (TMHCA), and the statewide National Alliance for Mental Illness (NAMI), NAMI Tennessee. Recruitment took place from March 2007 through March 2009 at local mental health agencies, and at residential and peer-run programs.|
737784|NCT01297920|Subjects were recruited and enrolled from 64 investigational centers in the United States.|Of the 1062 enrolled, 372 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (690), as treated.
737785|NCT01297595||
737786|NCT01297517|Subjects were recruited from 68 study centers in the US.|Of the 1001 enrolled, 341 subjects did not qualify for treatment and were exited without exposure to product. The 660 subjects eligible for treatment were randomized (1:1:1) to study drug. This reporting group includes all randomized subjects, as treated.
737787|NCT01297504||
737788|NCT01297491||
737789|NCT01297465||
737790|NCT01297348||
737791|NCT01297335||
737792|NCT01297322||
737793|NCT01297309|The study was conducted at 12 study centers in the United States between 06 April 2011 (first participant first visit) and 08 June 2018 (last participant last visit).|A total of 51 participants were enrolled and 49 participants received treatment out of them 37 participants completed the study.
737794|NCT01297283|200 patients were enrolledand were followed for at least 1 month in 25 institutions in France (max 50 patients per center). The first patient was enrolled on 16th of September 2010. The last patient was enrolled on the 13th of September 2011. The last follow-up visit took place on 5th of December 2011.|The point of enrollment was defined as the time before device implant at which a patient has signed and dated the Informed Consent Form. At that point, the patient needed to be followed for the duration of the study (until the 1-Month Follow-Up visit) unless a Study Exit Form was completed.
737795|NCT01297270||
737796|NCT01297257|Patients were enrolled at 163 centres in Europe, Asia, the Middle East, and Latin America from January 2011 to May 2012.|"7845 subjects enrolled in this study. 22 Subjects removed from database, per center request. Reasons varied per center.
~83 patients had very limited data available which resulted in the inability to be included in the analysis."
737797|NCT01297244|Subjects who met all the inclusion and none of the exclusion criteria were enrolled in 2 sites in the United States and Canada.|All screening assessments were performed within 21 days prior to the first dose of study drug. All subjects underwent inclusion exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study-related procedures.
737798|NCT01297062||
737799|NCT01296932|This was a Phase-1,single arm,open-label,dose escalation trial, patients with advanced chronic lymphocytic leukemia. While the first part of the trial was still in progress, recruitment was ended by the sponsor before the maximum tolerated dose(MTD) or Optimal Biological Dose(OBD) was reached.|All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
737800|NCT01296841||
737801|NCT01296815||
737802|NCT01296763||
737803|NCT01296698||
737804|NCT01296672||
737812|NCT01296152|Twenty-five HIV-1 infected women, ages 15 to 47 years, were recruited at 13 U.S. Clinical Research Sites and U.S. National Institute of Allergy and Infectious Diseases and National Institute of Child Health and Human Development-funded International Maternal Pediatric Adolescent AIDS Clinical Trial sites between June 1, 2011 and July 26, 2012.|Eligible participants: pre-menopausal HIV-1 infected females, >=13 years, plasma HIV-1 RNA <=400 copies/mL and cluster of differentiation 4 (CD4+) count >= 200 cells/mm^3 within 30 days prior to entry. Last menstrual period <=35 days prior to entry. If >35 days, follicle stimulating hormone (FSH) must have been <=40 Milli-International units/mL.
737813|NCT01296035||
737814|NCT01295905|Participants were recruited and enrolled from six (6) US study centers.|This reporting group includes all enrolled participants.
737815|NCT01295879||
737816|NCT01295840|The recruitment target is approximately 50 patients. Recruitment will be competitive, and will last for approximately 12 months, plus six months of follow-up. The trial will finish once all the patients have completed the follow-up.|
737817|NCT01295827|Participants with a histologically- or cytologically-confirmed diagnosis of any type of carcinoma (solid tumors), melanoma (MEL), or non-small cell lung cancer (NSCLC), with progressive locally advanced or metastatic disease, were recruited.|Of 1260 participants enrolled or randomized to the study, 1235 received at least one dose of treatment (All Treated Population) and were evaluable for all safety and efficacy analyses. Part E did not enroll any participants.
737818|NCT01295814|subject were recruited from medical practices and by advertisement starting March 2011 through January 2013.|A total of 4 subjects did not meet screening criteria.
737819|NCT01295710||"The Enrollment number of 260 participants in the Protocol Section represents the number of patients who were randomized.
~The number of 254 participants who Started in the Participant Flow module represents the number of patients who were randomized and were treated."
737820|NCT01295671|Subjects were recruited from the Boston metro area via multiple recruitment methods (i.e., print media, social media) from February 2011 through October 2014.|3607 participants were initially telephone screened; 1462 were eligible after telephone screening; 407 were eligible after an Informational Visit; 222 provided informed consent; 19 withdrew or were found ineligible prior to completing baseline assessments. 203 participants completed baseline assessments and were randomized.
737821|NCT01295515||
737822|NCT01295320||
737823|NCT01295281||"107 subjects were enrolled in the study but 105 started treatment, i.e. two subjects dropped out before start of treatment. Both these subjects missed to fulfil all inclusion criteria.
~53 subjects started using LoFric Polyolefin Based Elastomer (POBE) 2.0 and 52 subjects started using LoFric Polyvinyl Chloride (PVC)."
737824|NCT01295216||
737825|NCT01295112|A total of 68 participants ≥18 years of age with a diagnosis of central retinal vein occlusion (CRVO) as determined by fundus photography and fluorescein angiography were enrolled in the study at 5 clinical centers.|
737826|NCT01295034||
737827|NCT01294917||
737828|NCT01294800||
737829|NCT01294787|The study consisted of a maximum 28 day screening period, and three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.|A total of 85 patients were randomized and 73 patients completed the study. Since this was a cross-over study a participant may be counted in more than 1 group: 77 participants were treated with QVA149, 83 participants treated with tiotropium and 77 participants treated with placebo. One randomized patient did not receive study drug.
737830|NCT01294748||
737831|NCT01294709||
737832|NCT01294696|The study was conducted in 54 trial centers: 18 in France; 4 in Italy; 5 in The Netherlands; 5 in Portugal; and 9 in the United Kingdom.|
737833|NCT01294683||Participants completed a 6-8 week washout then completed a 2-week placebo run-in prior to the start of active treatment.
737834|NCT01294644|The study was conducted at 29 study centers in the European Union.|The study consisted of a 12-week treatment period and a 12-week safety follow-up period.
737835|NCT01294592||Treatment-naïve men with symptomatic benign prostatic hyperplasia (BPH) meeting eligibility criteria were enrolled and were randomized in a 1:1 ratio to receive dutasteride plus tamsulosin once daily plus lifestyle advice or watchful waiting plus lifestyle advice.
737836|NCT01294579||Subjects completed represents subjects who completed treatment.
737837|NCT01294553|The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Avandamet in the real clinical setting after launch.|
737838|NCT01294514||
737839|NCT01294462|In total, 817 patients were enrolled from 3 countries (Japan, South Korea and Taiwan). Of the randomised patients, most patients were Japanese (723 [90.3%]). The first patient was enrolled on 28 February 2010 and the last patient completed the study on 31 July 2012.|"In total, 801 patients (401 in the ticagrelor [AZD6140 90 mg bd] group and 400 patients in the clopidogrel [clopidogrel 75 mg od] group) were randomised to treatment. The reasons for not being randomised were Incorrect enrolment before randomisation and Patient decision (withdrawal of consent)."
737840|NCT01294449||For this trial permission was received by several institutional review boards to include subjects death information for participants in the MADIT-CRT IDE (NCT00180271) who died between the end of the IDE and the start of the Registry. This includes 14 subjects, 7 from each arm.
737841|NCT01294436|First subject enrolled: 28-Feb-2011; Last subject last visit: 15-Sep-2012; 1030 participants were enrolled in 56 Japanese centers. 728 Japanese men and women aged >=20 years with inadequate glycemic control (HbA1c levels of 6.5% to 10.0% prior to study treatment) with diet and exercise were treated.|A 6-week wash-out period was applicable only for subjects with ongoing anti-diabetic treatment at enrolment. A 4-week lead-in period was applicable for all subjects.
737842|NCT01294423|First participant enrolled: 25 Feb 2011. Last participant completed 24 week period: 12 Mar 2012. 354 participant were enrolled in 30 Japanese centers. 261 participants were randomized. Japanese men or women aged >= 20 years with inadequate glycemic control (HbA1c 6.5% to 10.0%) with diet and exercise.|Wash-out period was applicable only for participants with ongoing anti-diabetic treatment at enrolment. Drug-naive participants skip the period and directly proceed to a placebo lead-in period.
737846|NCT01294358||7 patients were enrolled, but only 6 were treated. Patient # 7 was consented and registered but developed pancreatitis before treatment. This patient was not treated.
737847|NCT01294319||
737850|NCT01294241|Participants were enrolled from 03 Nov 2010 to 14 Jun 2011 at 1 center (University Medical Center Freiburg) in 1 country (Germany).|12 wounds in 10 participants (2 cycles of treatment in 2 participants) were treated with study medication. The reepithelialization was compared intra-individually in either 2 halves of an Epidermolysis bullosa (EB) wound ≥10 cm2 and ≤200 cm2 in size or in 2 EB wounds ≥5 cm2 in size, i.e. the total number of participants was 10 in the overall study.
737851|NCT01294228||
737852|NCT01294163|"A total of 542 patients were enrolled (509 met the inclusion criteria) from 17 centres in 4 countries; 8 sites in France, 6 sites in Germany, 1 site in Italy and 2 sites in The Netherlands.
~Date of first enrolment: 20 April 2011 Date of last completed: 05 April 2014"|
737853|NCT01294150|The first subject was enrolled into the L.I.F.T. clinical study on February 8, 2011. Study enrollment was completed on December 14, 2011 and the final subject reached the 12-month study endpoint on December 5, 2012.|Washout of for 3 months (5ARI) and 2 week (alpha blocker) required before baseline questionnaires.
737854|NCT01294098||
737855|NCT01294046|Protocol required 3 subjects who were from the Cleveland Clinic migraine patient population.|This is a one arm study
737856|NCT01293968||
737857|NCT01293825||
737858|NCT01293695|Recruitment occurred from December, 2008 to April, 2012. Participants were recruited by using fliers, mailings, billboard advertising and word-of-mouth. Local clinics were also visited and informative materials were left with physicians.|
737859|NCT01293682||
737860|NCT01293539||
737861|NCT01293240||
737862|NCT01293123||
737863|NCT01293084||Data could not be retrieved for the order of randomization.
737864|NCT01293032|Once a patient consented to this study and was deemed eligible the core biopsy blocks or slides were sent to obtain the Oncotype DX Breast Cancer Assay. After the Recurrence Score(RS) results were available the subject was assigned to Group 1, 2, or 3. If assigned to Group 2 they were randomized to Arm 1 or Arm 2.|5/64 subjects were not assigned or randomized to an arm: delayed oncotype result, core block lost, discrepancy in a bio-marker test, and two subjects deemed not eligible. There were 5 subjects who refused assigned randomization Group 2 Arm 2. 2/5 subjects who refused Group 2 Arm 2 were treated and evaluable for response on Arm 1.
737865|NCT01293006||
737866|NCT01292928|A total of 299 subjects were enrolled and treated with the Innova™ Self-Expanding Stent System in this prospective, single-arm, non-randomized clinical study at 49 investigative centers in The Unites States, Canada, Japan and Europe, from 1 April 2011 to 28 June 2013 (with a temporary enrollment suspension from 13 May 2011 to 25 April 2012)|
737867|NCT01292876||
737868|NCT01292837|"This multicenter study started to enroll subjects in Februray 2011 in order to end up with 8 sites in Japan with enrolled subjects.
~Participant Flow refers to the Enrolled Set (ES). ES consists of all subjects who signed the consent form and participated in the Prospective Baseline Period."|
737869|NCT01292798||
737870|NCT01292746||
737871|NCT01292642|Subjects were recruited via online and newspaper advertisements.|Four participants were determined to be ineligible due to significant active Axis I psychopathology other than nicotine or cannabis dependence, one was ineligible due to an active medical issue that was referred for treatment, and one was ineligible due to a positive urine toxicology screen for an illicit substance other than cannabis.
737872|NCT01292629|Subjects who were >50 years of age, either sex, and any race were eligible for this study. Diagnosis of cataracts in one or both eyes.|Subject's eligibility was determined at the preoperative visit. All subject met inclusion/exclusion criteria.
737873|NCT01292603||In Part 1 a single dose of subcutaneous (SC) rituximab was administered at Cycle 6 to select a dose resulting in trough concentration (Ctrough) non-inferior to intravenous (IV) dose. In Part 2, participants were randomized to receive rituximab IV or SC, to demonstrate non-inferiority of rituximab Ctrough levels of SC dose compared with IV dose.
737874|NCT01292538||
737875|NCT01292486|Patients requiring a first peripheral blood stem cell collection and transplant for multiple myeloma were recruited at four clinical centers from March through October, 2011.|This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
737876|NCT01292473||
737877|NCT01292447||
737878|NCT01292304||
737879|NCT01292265|"This study started in February 2011. It was subsequently terminated due to low enrollment.
~Baseline characteristics refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Certolizumab Pegol (CZP) at least once.
~There was a total of 3 subjects enrolled in this study."|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.
737880|NCT01292239|The study was conducted between 17-January-2011 and 22-October-2012 and recruited participants with chronic genotype 1 Hepatitis C Virus (HCV) infection who were treatment-naïve from 37 study centers in Japan. A total 183 participants were randomized and started treatment; 172 completed the study.|Treatment-naïve HCV-infected participants were assigned to 1 of 2 groups to receive TMC435 100 mg once daily with PegIFN alpha-2a and ribavirin (PR) until Week 12, followed by PR until Week 24 or 48 OR placebo with PR until Week 12, followed by PR until Week 48.
737881|NCT01292226||
737882|NCT01292187|"Subjects will be recruited from outpatient populations associated with health care centers that treat osteoporosis. Community advertising may also be used for those not associated with such centers.
~Recruitment began on 17 January 2011."|All patients had a two-week single-blind oral placebo (at bedtime) run-in period before group assignment. This was to accustom the patients to the oral dose regimen prior to randomization
737883|NCT01292135||
737884|NCT01292070|One center in Australia recruited four participants with a history of allergic reactivity to cats as expressed by allergic rhinitis and who had reactivity to standardized cat hair allergenic extract|
737885|NCT01292057||
737886|NCT01292005|Subjects were enrolled from the Mayo Clinic in Rochester, Minnesota between 2009 and 2012.|30 subjects signed informed consent; two subjects were excluded after consent because they were found to be not eligible.
737887|NCT01291836||
737893|NCT01291173||A site with 11 enrolled subjects was excluded from study. An external investigation was initiated for reasons unrelated to the respective study. Lacking information on the purpose or scope of the investigation, it was deemed prudent to exclude data from subjects enrolled at site from the primary analyses of efficacy and safety.
737894|NCT01291160||
737895|NCT01291108||Pts were randomized at Baseline for the entire study. At Mo 1, pts received either AGN-210669 or bimatoprost. At Mo 2, pts who had received AGN-210669, then received either AGN-210669+bimatoprost or AGN-210669+bimatoprost vehicle and pts who had received bimatoprost, then received either bimatoprost+AGN-210669 or bimatoprost+bimatoprost vehicle.
737896|NCT01291056|Eligible participants were identified by physicians at the Utah Center for Reproductive Medicine at the University of Utah and provided written informed consent before being randomized to treatment groups.|
737897|NCT01291017||
737898|NCT01290978|Study was conducted between 22 Feb and 5 March 2010. Twenty-four male or female healthy volunteers between ages of 18 and 65 were screened for this study in order to ensure that at least 20 volunteers were enrolled. Volunteers were recruited from a pool of suburban men/women who met the exclusion/inclusion criteria.|Volunteers who met the exclusion/inclusion criteria were required to undergo a 1-day washout period where they were not allowed to use any moisturizing products or other skin contact materials on their backs. Two subjects were screen failures.
737899|NCT01290952||630 patients was the planned estimated sample size needed to test the null hypothesis. An interim analysis was scheduled at 400 enrolled patients, to verify the null hypothesis used for the sample size calculation. A p<0.0294 was considered statistically significant to reject the null hypothesis, thus study enrollment was stopped at 411 patients.
737900|NCT01290913||
737901|NCT01290887|A total of 1052 patients with eosinophilic asthma at 201 centers in 30 countries were enrolled in this study.|Four hundred-eighty (46%) patients received reslizumab for the first time in Study 3085, having previously received placebo in Studies 3081, 3082, or 3083.
737902|NCT01290874|Initial enrollment began March 30, 2011 at the Asthma Research Center at Brigham and Women's Hospital. Subjects were recruited with print advertisements, internet postings, physician referrals, and by contacting patients in databases who asked to be contacted for studies.|Subjects on combination ICS/LABA were switched to equivalent-dose ICS monotherapy at the same time they were assigned to the Tiotropium vs. LABA arm of the study.
737903|NCT01290822|"Data could not be analyzed due to poor enrollment and lack of data. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."|
737904|NCT01290796||
737905|NCT01290757||In this crossover study, subjects were randomly assigned to one of the 2 sequences, with 2 treatment arms. In general terms, Ref-Test-Ref-Test and Test-Ref-Test-Ref. The aim was bioequivalence comparing (Ref) Dabigatran 150mg in the currently approved capsule shell (Qualicaps) to the test of Dabigatran 150mg in a new shell (Capsugel).
737906|NCT01290731|The study was conducted between 22-Dec-2010 to 13-Aug-2012 and recruited participants with chronic Hepatitis C Virus (HCV) infection from 12 study centers in Japan. A total of 49 participants with chronic genotype 1 HCV infection were randomized and started treatment. A total of 48 participants completed the study.|HCV-infected participants who received at least 24 weeks of interferon (IFN)-based therapy and relapsed within 1 year after the last medication intake received treatment with TMC435 100 mg once daily with PegIFN alpha-2a and ribavirin (PR) until Week 12,followed by PR until Week 24/48 based on response-guided treatment (RGT) guidelines.
737907|NCT01290718||
737908|NCT01290679|The study was conducted from 18 January 2011 to 5 February 2013. The study was conducted at 76 sites in 14 countries.|393 participants were randomly allocated to the 2 treatment arms. 391 participants received at least 1 dose of study medication and were included in the intent-to-treat analysis set.
737909|NCT01290666|A total of 93 subjects were recruited from 11 sites between March of 2011 and September 2013.|
737910|NCT01290640|09/2011-12/2012, hospital|
737911|NCT01290627|Patients were recruited from the Colorado Joint Replacement practice of Drs. Doug Dennis and Brian Haas in Denver, CO after the study was approved by respective IRBs beginning 5/27/11.|
737912|NCT01290614||
737913|NCT01290601|70 subjects were randomized and hospitalized at the Bangkok Hospital for Tropical Diseases for the first 29 days of the study and asked to remain in a malaria non-endemic area until 90 days after study start. Subs had f/u's at D60 and D90, and were contacted at D120 for follow-up blood smear. Subjects remained in the study for 121 days.|During the IDMC review it was determined that Cohort 1 failed to meet the pre-specified endpoint for the day 28 cure rate and therefore Cohort 2 should not be initiated and follow-up in Cohort 1 should be completed according to protocol. Following last subject last visit for Cohort 1 the study was terminated.
737914|NCT01290536|Between May 2010 and October 2013, 42 adult patients with liver-dominant metastaticd colorectal or neuroendocrine cancer to the liver, or intrahepatic cholangiocarcinoma were enrolled in a prospective single-institution pilot study.|
737915|NCT01290523|Yttrium-90 radioembolization there were 14 total patients who signed consent and participated in the study. Enrollment started in May2010 and ended in June 2013.|A 2nd radioembolization treatment was allowed if patients had bilobar tumors and were willing to get repeated treatments.
737916|NCT01290484||
737917|NCT01290445||
737918|NCT01290341||
737919|NCT01290315|Hospitals and Medical Clinics. December 6, 2010 through October 13, 2012.|Discontinuation prior to dosing included lost to follow-up, subject request, and selection criteria/study compliance. A total of 19 subjects were excluded from the population of subjects evaluated for efficacy and safety-5 randomized to FCM 500mg, 2 randomized to FCM 750mg, 6 randomized to iron sucrose 500mg, and 6 randomized to iron dextran 750mg.
737920|NCT01290263|As of August 1, 2013, Cohort A was closed to new accrual following early interim analysis of first 10 participants enrolled on study showed insufficient efficacy per design.|
737921|NCT01290237||
737922|NCT01290224|Ten (10) participants were recruited at Mayo Clinic between February 2011 and April 2011. All 10 participants have completed sham procedure (day 1) and proceed to scrambler treatment (day 2 to 11).|
737923|NCT01290094||
738023|NCT01285323|A total of 1111 patients were screened for this study. Of the 1111 patients screened, 464 patients at 82 centers in 15 countries were randomly assigned to double-blind treatment.|
737924|NCT01290068|Participants were recruited from 20 investigative sites located in France (3), Germany (4), Great Britain (1), Italy (3), Netherlands (4), and Spain (5).|This reporting group includes all randomized participants, as randomized.
737925|NCT01290029|The study was conducted at 7 study centers in Belgium (1 site), Germany (1 site), the United Kingdom (2 sites), and the United States (3 sites). The first participant was enrolled 25 January 2011 and the last participant on 25 August 2015.|Due to blood volume collection limitations in children, participants were randomized in a 1:1 ratio to one of the following 2 pharmacodynamic (PD) sampling sequences: 2, 8, and 48 hours postdose; or 2, 12, and 48 hours postdose.
737926|NCT01289990||
737927|NCT01289912||
737928|NCT01289847|First enrollment: 06 April 2011; Last Subject completed 23 April 2014; Nine recruiting sites globally: United States (US) (seven sites), Chile (one site) and Israel (one site)|This was a Phase IV, multicentre, open-label, non-randomised study. All enrolled subjects received study medication.
737929|NCT01289821|Male or female participants with histological or cytological documentation of adenocarcinoma of the colon or rectum that was unresectable or unlikely of becomining resectable, who were at least 18 years of age and were suitable to receive mFOLFOX6 regimen as first line treatment could participate in this study at 16 centers in 7 countries.|Of 66 enrolled participants, 54 received study medication, 4 withdrew consent during screening, and 8 were screen failures due to no measurable lesion, not suitable to receive mFOLFOX as 1st line regimen (2), uncontrolled hypertension, symptoms/signs/history of brain metastases, glomerular filtration rate too low (2), and protein in spot urine
737930|NCT01289782|The study was conducted from 18 January 2011 to 29 January 2013. The study was conducted at 71 sites in 13 countries.|395 participants were randomly allocated to the 2 treatment arms. 394 participants received at least 1 dose of study medication and were included in the intent-to-treat analysis set.
737931|NCT01289678||
737932|NCT01289665||
737933|NCT01289639||
737934|NCT01289574||
737935|NCT01289548|Patients scheduled for living donor renal transplantation in the Department of Transplantation, Tongji Hospital, Huazhong University of Science and Technology were recruited in the project from May 2010 to November 2011.|68 pairs of patients were enrolled during the recruitment period. among them, 5 recipients had the history of renal transplantation before; 2 recipients had concomitant diabetes mellitus; and another one recipient had severe varicose vein in his lower limb. The left 60 pairs of donors and recipients (120 in total) were finally assigned to groups.
737936|NCT01289522||
737937|NCT01289457||
737938|NCT01289431||
737939|NCT01289418||
737940|NCT01289392|sleep disorder clinic|
737941|NCT01289275|Smokers hospitalized at participating healthcare systems UCSD, Scripps, and UC Davis) between August 2011 and November 2013.|Inclusion criteria: adults, speak and read English or Spanish, smoked prior to hospitalization, cigarette consumption greater than 5 cigarettes per day.
737942|NCT01289210||
737943|NCT01289119|Participants took part in the study at 30 investigative sites in China, Taiwan province and Hong Kong from 23 December 2010 to 19 December 2011.|Participants with a historical diagnosis of Type 2 diabetes mellitus who were experiencing inadequate glycemic control were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily.
737944|NCT01289080|The trial was an open-label, multicenter, parallel-arm, single-dose trial in two groups: 1 group of participants with normal renal function and 1 group of severely renally impaired participants.|The participant assignment was made based on Urine Creatinine Clearance (urine CLcr). If the urine CLcr was < 30 mL/minute for renally impaired participants and the urine CLcr was > 80 mL/minute for participants with normal renal function.
737945|NCT01289067|Recruitment began in December 2010. Thirteen (13) patients from Mount Sinai Medical Center were enrolled to the study between January 27, 2011 and March 7, 2013.|
737946|NCT01289041||
737947|NCT01289028||
737948|NCT01289015||
737949|NCT01288989||Cohorts 1-4: Trial completion was defined as completion of the dose-limiting toxicity (DLT) period (4 weeks of IMC-3C5 followed by 2 weeks without drug) or IMC-3C5 discontinuation due to DLT. Cohort 5: Trial completion indicated that participants were fully observed for primary and secondary outcomes.
737950|NCT01288976|The ACCESS-EU Phase I Study began enrolling patients in October 2, 2008 and completed enrollment on April 13, 2011. There were 567 patients enrolled at 14 investigational sites in Europe. The last follow-up visit occurred on June 15, 2012 and the last monitoring visit occurred August 9, 2012.|
737951|NCT01288937|"Patients will be recruited from the practices of the investigators of the peripheral neuropathy center. These subjects will already be receiving treatment in the clinics and private practices of neurologists at the Neurological Institute.
~Patients will also be recruited from physician referrals and advertising."|Prior to randomization, subjects are assessed at baseline with neurological examinations, physical examination and pain questionnaire/diary.
737952|NCT01288911|Men with metastatic castration-resistant prostate cancer (mCRPC) were enrolled at 84 sites in a total of 8 countries.|Participants were stratified by whether bilateral orchiectomy or receipt of luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy started before or after the diagnosis of metastases and by site.
737953|NCT01288859|The recruitment was performed at the ambulatory of Department of Food Science (University of Naples) among students of Agriculture Faculty. It began on December 2010 up to February 2011.|Subjects were enrolled after signing a Consent Form and were randomized to the treatments. All subjects enrolled completed the study.
737954|NCT01288833||
737955|NCT01288807||
737956|NCT01288781|Participants attending the Antur Ymchwil 2011 Expedition to the European Alps were recruited between 01.07.11 and 01.08.11.|Participants completed two trials, including a 12 hour sea level exposure followed by a 36 hour high altitude exposure (3777m). Participants were assigned to one of two groups based on High-altitude headache susceptibility determined by visual analogue score obtained after 12 hours at high altitude. No participants were excluded.
737957|NCT01288729||
737958|NCT01288612|Eligible participants were identified using the Rochester Epidemiology Project resources from Olmsted County, Minnesota residents. The study took place between 1 April 2011 and 30 October 2013.|
737959|NCT01288534||
737960|NCT01288521|Kidney transplant recipients were recruited from the transplant clinic from 10/2008 to 6/2010.|Assignment to the treatment group was based on CYP3A5 genotype and subjects were eligible only if they had the *3/*3 genotype. 22 subjects were consented to participate. Based on genotype, 3 subjects were ineligible to complete the study. Of the 19 eligible subjects, 11 declined to participate. 8 subjects completed the study.
737961|NCT01288469|The study was conducted at 20 centers in the United States of America. Overall, 214 participants were screened between January 2011 and April 2011. Screen failures were mainly due to exclusion criteria met.|Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1 ratio after confirmation of selection criteria. 92 participants were randomized.
737962|NCT01288443|The study was conducted at 38 centers in the United States of America. Overall, 514 participants were screened between January 2011 and August 2011, 331 of whom were screen failures and screen failures were mainly due to exclusion criteria met.|Randomization was stratified according to atorvastatin dose. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1:1 ratio after confirmation of selection criteria. 183 participants were randomized.
737963|NCT01288430|A total of 60 participants who met all inclusion and no exclusion criteria were enrolled in the study.|Part 1: Dose escalation began with an accelerated titration design, with a starting dose of DS-2248 0.6 mg/m^2 once daily. Part 2: Dose expansion was assessed in participants with Stage IIIB/IV non-small cell lung cancer with resistance to epidermal growth factor receptor tyrosine kinase inhibitor or ALK inhibitor therapy.
737964|NCT01288287|This observational study started to enroll patients in July 2011 in the United Kingdom and Ireland.|Of the 149 enrolled patients, 147 are included in the Safety Set.
737965|NCT01288209|The study was conducted between 05-Jan-2011 to 05-Sep-2012 and recruited participants with chronic Hepatitis C Virus (HCV) infection from 23 study centers in Japan. A total of 108 participants were randomized, 106 started treatment, and 101 completed the study.|Participants with genotype 1 HCV-infection who failed a previous course of interferon (IFN) based therapy received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) until Week 12 (OR Week 24), followed by PR until Week 24/48 based on response-guided treatment (RGT).
737966|NCT01288079|This multicenter study was conducted in Europe, Asia, and North America between 4 February 2011 and 26 April 2012.|21-day screening/washout and 8-week prospective open-label SSRI(selective serotonin reuptake inhibitors)/SNRI(selective serotonin and norepinephrine reuptake inhibitors) periods to identify population of inadequate responders(<50% reduction in Hamilton Rating Scale for Depression total score of ≥16 and a Clinical Global Impression-Severity ≥4).
737967|NCT01288053||
737968|NCT01288027|The study was conducted at 11 centers between July 06, 2011 and December 19, 2013.|
737969|NCT01287897|This study included a 28-day screening period, an induction period (Week 0-12) and a 28-week follow-up period. Participants who completed the induction treatment period could enter the follow-up period or an open-label extension study, NCT01345318. Participants who discontinued treatment during the induction period could enter the follow-up period.|A total of 250 participants were randomized via Interactive Voice Response System (IVRS); of which, 247 received investigational product and 3 were randomized inadvertently and not dosed (2 did not meet entrance criteria and 1 did not consent properly and was not included in clinical database because the randomization page was not completed).
737970|NCT01287832||
737971|NCT01287754||All participants underwent EGFR mutation testing at Screening. Those positive for the EGFR mutation and who met eligibility criteria (number of participants [n] = 3) received treatment with erlotinib. The remaining participants (n = 21) were followed for overall survival but did not receive treatment.
737972|NCT01287741||A total of 1418 patients were randomized and included in the primary analyses (29 April 2016). A total of 1414 patients were included in the final analysis (31 January 2018), 710 in the R-CHOP arm and 704 in the G-CHOP arm; data from 4 patients were excluded because of serious GCP non-compliance at a single study site in China.
737973|NCT01287611||
737974|NCT01287520||"The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have completed the trial if they discontinued treatment due to progressive disease or an adverse event."
737975|NCT01287416|Various methods of advertising for volunteers was used (i.e., radio advertisements, newsletters, posters). Community activities were organized by community representatives in an effort to recruit individuals to participate in the study (i.e., through a bingo night, barbecue, etc.) between May 2010 and May 2011.|From all eligible applications, we selected participants using a random number generator based on receipt of application until we had six adolescents, four adults, and two elders in each community who met criteria for participation in the study.
737976|NCT01287403|14 healthy subjects were recruited within the staff of the Nestle Research Center. After being informed, by written and orally, on the aims, methods, risk/benefit ratio for the study, they signed an informed consent form and underwent a medical visit screening as per protocol|"Thirteen subjects completed the trial, where 100 g of each flour, mixed with 300 mL milk, was fed to all subjects.
~Subjects avoided foods containing whole grains for one week prior, and 36 h before the start of each treatment, to avoid all phenolic-rich foods (e.g. coffee, tea, chocolate, most fruits and vegetables)."
737977|NCT01287377|Recruitment period from 11/8/2010 - 1/18/2011|
737978|NCT01287364||
737979|NCT01287221|Subjects were enrolled from 10 specialized tertiary centers in the United States from April 2011 through April 2012.|
737980|NCT01287208|Medical residents were recruited during ambulatory care blocks from July 2010 through November 2010.|Subjects were randomized at the end of December 2010. Four residents withdrew prior to randomization (1 changed mind, 2 said they did not have time, 1 did not complete baseline assessment).
737981|NCT01287195||
737982|NCT01287117||Randomized population: All randomized participants regardless of whether they received any study drug.
737983|NCT01287104||
737984|NCT01287078||Two subjects withdrew consent after signing
737985|NCT01287065||
738021|NCT01285401||Total 260 subject were enrolled, out of which 232 subjects were randomized and started the study. 229 subjects were treated since 3 subjects of the 232 randomized subjects were excluded from analysis as they did not received any medication.
738022|NCT01285349||
737986|NCT01287039|A total of 1486 patients were screened at 121 centers. Of the 1486 patients screened, 489 patients with asthma and blood eosinophils ≥400/ μL at 102 centers in 17 countries were randomly assigned to double-blind treatment.|997 of 1486 screened patients were not randomized: 888 were excluded on the basis of not meeting inclusion criteria, 23 withdrew consent, 17 had an adverse event during the screening period, 12 met an exclusion criterion, 7 were lost to follow-up and 50 were excluded for other reasons. One placebo patient was randomized but not treated.
737987|NCT01287013|Recruitment period = 2/4/2011 - 5/15/2014 Recruitment location = Interventional Radiology Clinic, Department of Radiology and Imaging Sciences, Clinical Center, NIH|The PILOT Arm of the study was done prior to enrolling participants in the main phase of the study. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures. Participants enrolled in the PILOT Arm were not randomized to either the Cone Beam CT or Conventional CT Arms and not included in the analysis.
737988|NCT01286987||Study was conducted in two parts: Part 1 was dose escalation phase (to determine the maximum tolerated dose [MTD]) and Part 2 was the dose expansion phase conducted at MTD determined in Part 1. Participants were different in both of the Parts.
737989|NCT01286870|The Becker CA Study was an open-label, multi-center study to provide continued physician and patient experience with the smooth Becker 25 and 50 Expander/Breast Implant. Subjects included women who required primary breast reconstruction.|
737990|NCT01286818||Eight (8) participants signed the informed consent.
737991|NCT01286805||
737992|NCT01286779|Enrollment was conducted at 40 clinical sites in 18 countries. A total of 117 participants were enrolled. Of these, 65 participants transitioned from BAX326 pivotal study, 20 participants transitioned from BAX326 pediatric study and 32 participants were newly recruited.|Of 117 enrolled participants, 115 received treatment with IP. All 85 participants who transitioned from the pivotal/pediatric studies continued to receive IP in this study. Of the 32 newly recruited participants, 30 received treatment with IP. 1 participant did not meet the entry criteria and 1 participant discontinued the study prior treatment.
737993|NCT01286753||Written informed consent for participation in the study was obtained before performing any study-specific screening tests or evaluations.
737994|NCT01286740|Participants were enrolled at 18 sites in the United States. The first participant was screened on 27 January 2011. The last participant observation was on 26 June 2012.|63 participants were screened, 50 were enrolled; 49 participants were treated, and comprise the Safety Analysis set. Participants in the Safety Analysis Set who had no major protocol violation comprise the Full Analysis Set.
737995|NCT01286558||
737996|NCT01286493||
737997|NCT01286480||
737998|NCT01286454||
737999|NCT01286441||
738000|NCT01286402||
738001|NCT01286324||
738002|NCT01286311|Physicians were recruited at their clinic offices in January 2011. They provided written informed consent to be randomized and to have study staff mail risk messages directly to patients on their behalf if they were randomized to the intervention. Patients were included with a waiver of consent.|
738003|NCT01286272||One hundred thirty five patients registered to this trial. However, 3 patients cancelled prior to receiving any study treatment and were excluded from all analyses.
738004|NCT01286259||
738005|NCT01286207||All participants that completed protocol MK-0462-022 (NCT00897949), MK-0462-025 (NCT00899379), or MK-0462-029 (NCT00897104) and consented to continue in the studies up to 12 months were included in this pooled extension data.
738006|NCT01286168|This study was conducted at the Mayo Clinic, Rochester, Minnesota, and the University of California, San Francisco, California. Eligible subjects were recruited prospectively from the breast surgical practices between May 2011 and June 2013.|Six subjects did not start study therapy: One subject became a screen failure when her procedure was changed to a lumpectomy. For one subject, no Dakin's solution was available at the pharmacy. Four subjects withdrew, changing their minds about participating.
738007|NCT01286129|Subjects were recruited from advertisement between November 2005 and october 2008|After enrollment, there was a one to 7 days run-in period. Subjects that could not produce a quality sputum sample were excluded from the trial.
738008|NCT01286077||
738009|NCT01286012||
738010|NCT01285960||
738011|NCT01285947||
738012|NCT01285908|Subjects were recruited through a NIH/NINDS screening protocol for Primary Chronic Autonomic Failure. Six subjects were enrolled during June 2011 to January 2012. Inclusion criteria required a confirmed diagnosis of neurogenic orthostatic hypotension related to Parkinson disease or pure autonomic failure.|Subjects underwent history and physical exam following consent. Subjects not meeting eligibility criteria were excluded prior to baseline testing. One subject was excluded prior to baseline testing due to recent stroke and one subject was terminated from the study during the testing phase due to examiner's inability to place an arterial line.
738013|NCT01285843||
738014|NCT01285791||
738015|NCT01285713||
738016|NCT01285635||Patients will receive arm specific therapy for the first two cycles, then all patients will be switched into the metronomic AT-101 arm for up to 10 cycles.
738017|NCT01285609||1289 participants were enrolled and 956 were randomized (479 Ipilimumab, 477 Placebo). 948 were treated (475 Ipilimumab, 473 Placebo). Reasons for non-treatment is 4 no longer met study criteria, 2 adverse events unrelated to study drug, 1 participant request to discontinue, and 1 other.
738018|NCT01285518|Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM), diagnosed according to the American Diabetes Association (ADA) guidelines and those with well-controlled diabetes were recruited in the study.|Dose of PF-05231023 was escalated based on sponsor's and investigator's discretion, depending upon safety, tolerability and pharmacokinetic profile of PF-05231023.
738019|NCT01285492|121 patients were randomized to the QVA149 group; however, demographics was on safety set and excluded 2 patients who did not take study drug|There was a pre-screening visit where informed consent was obtained and current COPD medications reviewed and in suitable patients, if necessary, arrangements were made to adjust prohibited COPD therapy to allowable COPD therapy. The interval between Visit 2 and 3 was a 7-days run-in period used to assess eligibility and to collect baseline values.
738020|NCT01285427|Not applicable. De-identified, archived whole blood samples|
738024|NCT01285310|A total of 302 subjects were screened for inclusion in this study, and 237 participants randomized in parallel in a 1:1:1 ratio to treatment groups. The first participant was enrolled on 27 December 2010; the last participant completed week 24 visit on 23 February 2012.|
738025|NCT01285076||
738026|NCT01285050||
738027|NCT01285024||
738028|NCT01284959||
738029|NCT01284634||
738030|NCT01284621||This was a randomised, open-label, three period, crossover study. Each treatment period was 8 days, with drug administration on days 1 to 5, and they were separated by a washout period of at least 7 days between drug administrations of 2 subsequent treatments.
738031|NCT01284517||
738032|NCT01284504|1 patient was consented but withdrew before treatment assignment (randomization), none were treated.|
738033|NCT01284491|Subjects' breasts were randomized individually to the PEAK PlasmaBlade or SOC group.|
738034|NCT01284426||
738035|NCT01284361|Recruitment period: October 10, 2010 - July 21 , 2011 types of locations: private vendor, public rehabilitation center, university|
738036|NCT01284335||Study completion was defined as when the recommended dose of LY573636 (tasisulam) was defined for each treatment arm or if a decision was made to stop enrollment in the study for business reasons.
738037|NCT01284296||
738038|NCT01284244||
738039|NCT01284140|Subjects were recruited from the medical intensive care units of the University of Chicago and the University of Iowa Hospitals and Clinics.|Two subjects who acutely developed exclusion criteria were withdrawn from the study after enrollment and prior to the performance of any study-related procedures. These subjects were not analyzed.
738040|NCT01284127||
738041|NCT01284114|Patients were recruited between February 2011 and December 2011 in Tochigi prefecture and Okayama prefecture in Japan|4 week observation period to fix any drugs, including existing antihypertensives
738042|NCT01284062||
738043|NCT01283971||
738044|NCT01283581|This study targeted patients with ABSSSI (acute bacterial skin and skin structure infections), defined as cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection; the minimum surface area was to be 75 square centimeters.|
738045|NCT01283555|Recruitment began on 26 January 2011 and ended on 10 March 2011. Recruitment was done at Clinica Profamilia, Santo Domingo, Dominican Republic. Healthy women, 18 to 50 years of age (inclusive), who attended the clinic for health care, who were not at risk for pregnancy, and at low risk of sexually transmitted infection were informed of the study.|25 were enrolled in this study which used a cross-over design. Participants were randomized to order of applicator use.
738046|NCT01283542||Twenty seven patients were screened and 21 met eligibility requirements.
738047|NCT01283516|Study was considered completed when all patients discontinued ceritinib treatment, & all required follow-up was completed or patient died, was lost to follow-up or withdrew their consent to further participate in study or last patient on treatment was enrolled to a separate protocol to continue receiving ceritinib treatment, whichever came first.|A total of 304 patients were treated with LDK378 in the study, including 59 patients from the dose-escalation phase (including 10 patients at 750 mg) and 245 patients from the expansion phase treated at LDK378 750 mg.
738048|NCT01283464|Study period: January 2011-December 2011 Recruitment period: January 2011-June 2011 Setting: Academic referral center|
738049|NCT01283386||
738050|NCT01283334|After institutional review board approval, the study enrolled 20 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (RMSCCHN).|
738051|NCT01283321|Enrollment started in February 2011 and the study was completed in May 2012. Subjects were recruited from Emory University. Fifty-one patients were approached after initial screening for eligibility, and 26 patients were consented.|Two subjects were excluded due to a change in surgical plans. Two subjects had low bleeding scores and were excluded.One subject had screening labs that were out of range for the study. One subject was treated using Dabigatran treatment. Total of six subjects that were excluded prior to randomization.
738052|NCT01283282|Patients recruited from clinic sites at Emory University Hospital, Crawford Long Hospital, Grady Memorial Hospital and VA Medical Center between January 2008 through December 2008.|
738053|NCT01283152|This randomized clinical trial was performed at Parkland Memorial Hospital, Dallas, Texas, from January 2011 to June 2012. All patients presenting to the emergency department with known cirrhosis and altered mental status (AMS) were eligible.|A total of 186 patients were screened; 50 eligible patients were randomized to standard-of-care treatment (lactulose) or PEG. The most common reasons for exclusion were that the patient had received more than 1 dose of lactulose in the emergency department prior to consent, that a LAR was not available, or that the patient did not have HE.
738054|NCT01283139||A total of 834 participants were screened out of which 402 participants did not meet eligibility criteria and were considered screen failures, and 432 participants were randomized into the study.
738055|NCT01283035||
738056|NCT01283022|Pregnant women who required to be induced were recruited at 1 site in the US|
738057|NCT01283009||
738058|NCT01282866||
738059|NCT01282814||
738060|NCT01282801||
738061|NCT01282723||
738062|NCT01282710||
738063|NCT01282476||
738064|NCT01282463||"Participants who died or discontinued treatment due to progressive disease (PD) were considered completers at the end of study. 8 participants were included in the never treated group due to death, PD, withdrawal, physician decision or protocol violation."
738065|NCT01282424|Participants were enrolled at a total of 54 study sites in North America and Europe. The first participant was screened on 04 March 2011. The last participant observation was on 16 May 2018.|125 participants were enrolled and treated and comprise the Intent-to-Treat (ITT) Analysis Set.
738066|NCT01282372||"The 'reason 1' and 'reason 2' for discontinuation for 'other' categories listed in participant flow is relocation, regression of symptoms, pregnancy, and loss of insurance coverage and participant withdrew consent and loss of insurance coverage, respectively. AE = Adverse Event."
738067|NCT01282294||
738147|NCT01277354|Recruitment for this project was slow and only two subjects matriculated during the period that this project was active.|
738148|NCT01277341||
738068|NCT01282242|Subjects were recruited between January 2011 and February 2016 from 14 sites across the continental United States, and enrolled in 10 of those sites.|Subjects diagnosed with acute ischemic stroke, last known well within 24 hours of triage and able to receive IV rt-PA within 4.5 hours from symptom discovery based on MRI findings consistent with early stroke onset, were eligible. MRI Signal Intensity Ration values were defined as <1.15 for the primary and <1.25 for the secondary arm of the trial.
738069|NCT01282229||
738070|NCT01282216||8 recipients and 8 donors were screen failures prior to starting the study. 8 additional donors were vaccinated, but their intended recipients were never vaccinated and were replaced on study due to early relapse or graft failure. Data for the latter 8 donors has been lost and their arm assignment cannot be determined.
738071|NCT01282203||
738072|NCT01282164|"A total of 28 patients with hypothalamic-pituitary disorders and 1-2 (n = 14) or 3 or more (n = 14) pituitary hormone efficiencies (PHD) were recruited from four pituitary centers.
~A control group of 14 subjects was also recruited and underwent the insulin tolerance test (ITT) and the two glucagon stimulation tests (GSTs)."|There was no wash out period. Patients and controls were eligible for the study after the initial office visit for eligibility criteria, signing the consent form followed by labs to make sure that they are eligible for the study. One patient was excluded since the patient did not achieve hypoglycemia during insulin tolerance test
738073|NCT01282138|Subjects were recruited from one study center in Canada.|
738074|NCT01282086||
738075|NCT01281969||
738076|NCT01281956||Two participants that were consented to the protocol, did not participate in the study procedures. One participant was screened but was not randomized and did not receive study drug or placebo and one participant did not return for screening visit.
738077|NCT01281917|Patients with relapsed or refractory B-cell NHL were enrolled from 10 sites within the Wisconsin Oncology Network (WON) between May 2011 and May 2013.|Forty participants were enrolled from 10 sites within the Wisconsin Oncology Network (WON) over 2 years. One participant withdrew consent immediately after enrollment and was never treated. Therefore, results are reported on the remaining 39 participants.
738078|NCT01281865|Protocol Open to Accrual: 01/20/2011 Protocol Closed to Accrual: 10/23/2012 Primary Completion Date (if applicable):10/22/2013 Recruitment Location is the medical clinic|
738079|NCT01281839|The study was conducted from 18 January 2011 to 4 February 2013. The study was conducted at 81 sites in 14 countries.|394 participants were randomly allocated to the 2 treatment arms. 393 participants received at least 1 dose of study medication and were included in the intent-to-treat analysis set.
738080|NCT01281644|The principal investigator selected patients presenting to the Dermatology Clinic at Northwestern Memorial Hospital who met the inclusion criteria. A brief, written description of the study was given to the patient.|
738081|NCT01281501|Enrollment began in January, 1 2011 and finished at the end October, 31 2011 in the Emergency Department of King Chulalongkorn Memorial Hospital|We analyzed the data for all enrolled patients with the intention-to-treat principles.
738082|NCT01281475||
738083|NCT01281306|This study consisted of a single-blind run-in period and a double-blind (DB) period. During the 3 to 4 week run-in, participants were assessed for randomization eligibility into the DB period. 910 participants randomized. 3 participants were mis-randomized and did not receive study treatment. Therefore, the participant flow shows 907 participants.|In the double blind period, participants were randomized in a 2:2:2:2:2:2:1 ratio to AHU377 400 mg + valsartan 320 mg, AHU377 200 mg + valsartan 320 mg, AHU377 100 mg + valsartan 320 mg, AHU377 50 mg + valsartan 320 mg,valsartan 320 mg, LCZ696 400 mg and placebo, respectively.
738084|NCT01281202||
738085|NCT01281124||
738086|NCT01281007||
738087|NCT01280981|Participants who completed double-blind therapy in either study XP12B-MR-301 (NCT00401193) or XP12B-MR-303 (NCT00386308) could participate in this trial.|
738088|NCT01280968||
738089|NCT01280955|Patients who are appropriate candidates for myeloablative allogeneic stem cell transplantation from an HLA-matched sibling, matched unrelated donor or umbilical cord blood are eligible for enrollment. The first subject was consented on 9/28/2011. The study closed to accrual on 5/27/2014.|41 participants signed consent and 30 received transplant. 11 patients who signed consent were screen failures. Reasons patients did not receive transplant included lack of donor, insurance denial, too much disease, uncontrolled infection, class III or IV angina. 29 participants were used in results analysis because one participant withdrew.
738090|NCT01280942||
738091|NCT01280903||
738092|NCT01280812||
738093|NCT01280721||
738094|NCT01280695|The study was conducted at 15 investigational sites between February 15, 2011 and July 6, 2011.|This study consisted of a 14-day placebo lead-in period and a 28-day double-blind treatment period. Eligible patients were randomized following the lead-in period based on a stratification criterion of current metformin use (yes, no) to one of the 5 treatments: MSDC 0602 100 mg, MSDC-0602 250 mg, MSDC-0602 500 mg, pioglitazone 45 mg, or placebo.
738095|NCT01280656|A total of 660 participants were enrolled from 39 centers in Brazil. The study was conducted from January 2010 to June 2013.|
738096|NCT01280604||
738097|NCT01280591||
738098|NCT01280552||
738099|NCT01280409||
738100|NCT01280357|Study was from Feb 2010 to Sept 2010 in a clinical setting at Queens Hospital Centre 82 - 68 164th Street Jamaica New York 11432|For all participants if there is any issue or exclusion from monitoring with the Monica AN24, fetal monitoring should continue using the Philips 50xm device
738101|NCT01280266|Recruitment begin Jan 13 2011 until Mar 15 2011. Location: Rheumatology outpatient clinic at Seoul National University Hospital, Seoul, Korea.|30 Patients were initially recruited, but an error occurred in obtaining informed consent and this one was withdrawn.
738102|NCT01280201|Between January 2011 and March 2012, a total of 44 patients were enrolled at 9 Spanish sites, belonging to Group for Neuroendocrine Tumors (GETNE).|
738103|NCT01280123||
738104|NCT01280110|Recruitment period started on March 2011 through December 2011 in the Department of Ophthalmology at the Hospital das Clínicas - State University of Campinas.|
738105|NCT01280058|Patients were randomized between February 2011 and April 2014|
738106|NCT01279954||
738107|NCT01279850||
738149|NCT01277302||
738108|NCT01279681|Thirty-two participants were enrolled between January 2011 and December 2012. The trial was terminated prematurely due to poor accrual and limited cooperative group resources. All follow-up was discontinued November 1, 2014.|Prior to randomization, physician chose fluoropyrimidine type [ie, oral Capecitabine (Xeloda) or infusional 5FU]. Patient was randomly assigned to arm A [fluoropyrimidine + bevacizumab (BEV)] or arm B [fluoropyrimidine/oxaliplatin (OXAL) + BEV] using chosen fluoropyrimidine. LV=Leucovorin, mFOLFOX7=5FU+LV+OXAL.
738109|NCT01279616||
738110|NCT01279564|Adult consenting patients that were admitted to Rambam Health Care Campus for laparoscopic sleeve gastrectomy were recruited between February and December 2011|All recruited patients were enrolled in the study, no one was excluded.
738111|NCT01279486||
738112|NCT01279447||
738113|NCT01279343||
738114|NCT01279317|recruitment by advertisements in local newspaper|none applicable
738115|NCT01279265||
738116|NCT01279200||
738117|NCT01279187||
738118|NCT01279109||147 were consented; 12 withdrew consent before randomization (reason: too much time to commit); 135 were randomized
738119|NCT01279070|Recruitment started on January 2007 and finished on May 2010. We have worked in different outpatient Rehabilitation Centers and we incorporated experimental and control group as a part of their rehabilitation planning. We have worked in 6 different centers.|
738120|NCT01279044|Recruitment involved outreach at community venues in San Francisco, including bars, clubs, grocery stores, gyms, and other venues frequented by MSM. To recruit a racially and ethnically diverse sample of episodic SUMSM, recruitment also occurred at community-based organizations serving African American, Latino, and Asian and Pacific Islander MSM.|Potential participants completed brief telephone screening to assess initial eligibility and, if eligible, were scheduled for in-person re-screening visits. If potential participants were ineligible at the re-screening visit, they were thanked for their time and did not continue with study activities, such as randomization in the RCT.
738121|NCT01278953||300 subjects consented and were randomized, 5 subjects did not have the study device introduced. Thus 295 subjects contributed to study endpoints.
738122|NCT01278927||
738123|NCT01278862||
738124|NCT01278797||
738125|NCT01278745|Twenty three out of N=24 participating sites in the United States enrolled 362 participants into this trial. N=163 participants reached the randomization stage of the trial.|
738126|NCT01278615||
738127|NCT01278485|This study enrolled a total of 726 Korean participants who had been treated with sulfonylurea monotherapy or sulfonylurea and metformin combination therapy for at least six months in the departments of Cardiology, Nephrology, and Family Medicine of various Korean hospitals and medical centers.|Seven participants who failed to meet all the inclusion criteria were excluded from the study.
738128|NCT01278407||In the 'Placebo to Donepezil (5+10 mg) Extension Phase' arm, 37 of 46 participants started active treatment at Week 16.
738129|NCT01278394|Subjects were screened and enrolled and two investigative sites in Mexico. The study population included men and women of any race, 18-65 years of age who had distal, subungual onychomycosis of the great toenail. The first subject visit occurred on March 28, 2007, and the last subject visit occurred on July 11, 2008.|All subjects in Cohort 3 were treated with 5.0% AN2690 Solution.
738130|NCT01278342||
738131|NCT01278303||
738132|NCT01278173||
738133|NCT01278160|This trial was conducted at 20 sites in China.|All subjects who completed the 24 week treatment and did not achieve the target of glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIAsp-3756 (NCT01123980) were offered the possibility to go into BIAsp-3883. Subjects continued their previous treatment unchanged from trial BIASP-3756 and throughout the one-week screening period.
738134|NCT01278030||
738135|NCT01277887|Randomized between 9/2/11-12/6/11 at an outpatient research clinic.|Prior to randomization, inclusion and exclusion criteria were assessed. Reasons for exclusion included CBT-I contraindicated medical/psychiatric conditions, not meeting smoking criteria, other drug dependence, and not meeting sleep criteria.
738136|NCT01277861|Patients were recruited for the study in the preoperative period.|Participants were included based on inclusion/exclusion criteria. Participants were excluded if muscle relaxation was necessary for the surgery.
738137|NCT01277822||
738138|NCT01277783||
738139|NCT01277757|Recruitment Period: March 14, 2011 to November 27, 2013. Recruitment done at The University of Texas MD Anderson Cancer Center, Beth-Israel Deaconness, Columbia University Medical Center, Dana Farber Cancer Center and Vanderbilt University.|Of the 30 participants registered, two were ineligible, not treated therefore excluded from the trial outcomes.
738140|NCT01277744|Recruitment Details: May 2011 to December 2013|One patient was enrolled twice; she received a second hyperthermic intraperitoneal chemotherapy surgery after she recurred following the first procedure
738141|NCT01277718||
738142|NCT01277666|A total of 608 participants with moderately-to-severely active Crohn's disease were enrolled in this study. The study was conducted at 162 centres in 23 countries, with sites in North America, Europe, Israel, South Africa, Japan, Australia, Korea and New Zealand. Study duration was from 20 December 2010 to 11 July 2013.|Of the total 1205 participants screened, 597 were screen failures and 608 participants were randomized in the study.
738143|NCT01277601|Participants were enrolled at study sites in North America, Europe, Asia, and Australia. The first participant was screened on 12 April 2011. The last study visit occurred on 17 July 2015.|1597 participants were screened.
738144|NCT01277549|Healthy adult donors were recruited at three blood collection centers to undergo a mononuclear cell collection using the experimental device, between January and September, 2011.|
738145|NCT01277523||
738146|NCT01277510|"The first patient was enrolled on 28 June 2011 and the last patient enrolled was on 15 January 2013.
~Eligible participants were between the ages of 6 to less than 18 years old who had chronic kidney (CKD) and secondary hyperparathyroidism treated with either hemodialysis or peritoneal dialysis for ≥ 2 months."|This study consisted of a 30-week randomized, double-blind phase followed by a 30-week open-label phase. Participants were randomized 1:1 to receive either cinacalcet or placebo in the double-blind phase. All participants received cinacalcet in the open-label phase.
738153|NCT01277042||The study comprised a Primary Vaccination Phase from Day 0 to Month 7, followed by a Long-Term Safety Follow-up Phase, up to Month 12.
738154|NCT01276860||
738155|NCT01276847||
738156|NCT01276821|"Subjects were recruited from previously healthy children aged 6 weeks to 24 months with first episode of wheezing who visited the OPD and ER of Kanti Children Hospital and met the clinical definition of bronchiolitis.
~Recruitment occurred on weekdays from 8:00 to 17:00 Hours. Out of 754 screened children, 159 were first episode wheezers."|
738157|NCT01276756||
738158|NCT01276652|Subjects were recruited from the medical ICU at the University of Chicago between November 2001 and December 2008. Subjects were randomized to receive the environmental modification or usual care during the first 48 hours beginning the morning after enrollment. Subsequently, we enrolled 5 subjects in an observational arm (usual care).|Two subjects were withdrawn by the PI after consent but prior to randomization, when they acutely developed exclusion criteria. One additional subject was withdrawn by the surrogate decision-maker prior to the initiation of the study. No data were collected on these subjects and they are not included in the results.
738159|NCT01276639||Outcome measures reporting results up to week 16 consist of single placebo arm as reporting group while outcome measures reporting results up to week 52 consist of 2 separate arms (for participants re-randomized at week 16 to receive CP-690,550 5 milligram [mg] or 10 mg).
738160|NCT01276535|12 subjects were recruited and enrolled from March 2, 2010 through April 29, 2010 at one medical clinic.|There were no significant events or approaches for the overall study following participant enrollment, but prior to group assignment. There were no enrolled participants excluded from the trial before assignment to groups.
738161|NCT01276509||In total, 265 participants were randomized and 262 entered the study and received study treatment.
738162|NCT01276457|This study was an 18-month extension to the 6-month core study NCT01276457. All patients who were receiving treatment at the end of the core study and signed the informed consent of the extension study were included. Patients received the same treatment in the extension study that they received in the core study.|
738163|NCT01276353||
738164|NCT01276327||
738165|NCT01276314|SCAR patients were enrolled in the clinical trial from 2009 to 2015 at Chang Gung Memorial Hospital in Taiwan.|We totally recruited 140 participants, but only 135 SCAR participants (including 91 SJS/TEN patients and 44 DRESS patients) were enrolled to analyze. 5 participants in the control group were not included to analyze (3 cases failed a screening with CD4<200 cells/mm3 and 2 cases as diagnosis change).
738166|NCT01276301||
738167|NCT01276288||This was a randomised, open-label, 2- way cross-over study. All patients received empagliflozin (EMPA). After 7days washout period, half of patients received hydrochlorothiazide (HCT), other half torasemide (TOR) on its own or with EMPA. Then HCT or TOR and its combination with EMPA were administered first, followed by EMPA after 7 days washout.
738168|NCT01276223|Subjects were recruited from 25 investigative sites located within the US. Participant flow data is presented for all all subjects exposed to product.|Of the 722 enrolled, 433 subjects did not qualify for Run-In and were exited without exposure to product. Of the 289 entering Run-In, 78 did not qualify for treatment. The 211 patients qualifying for treatment were randomized 1:1 to receive either Durezol or Vehicle.
738169|NCT01276197||
738170|NCT01276171||
738171|NCT01276106|The participants were recruited in 21 study centers, which were located in 2 countries (USA and Taiwan)|
738172|NCT01276054|Recruitment for this trial opened in December 2010 and closed in June 2011 at which time the protocol was terminated due to the departure of the Principal Investigator.|The study has no pre-assignment.
738173|NCT01276041||
738174|NCT01275833||
738175|NCT01275755||
738176|NCT01275677||
738177|NCT01275664|This trial was opened to patient entry on June 13, 2011 and was closed to accrual on December 12, 2011. The trial closed early because enrollment into this study was dependent on accruing patients simultaneously with GOG 252 (NCT00951496). When GOG 252 closed, there was no patient population to recruit from for this study.|
738178|NCT01275625|This report presents results of a 48 week study conducted at 8 centers in Russia. A total of 98 subjects were enrolled in the study; however, one site was closed and data from this site was deemed unusable, thus in total 77 subjects were included in the analysis.|Treatment naïve Human Immuno Deficiency Virus (HIV) infected participants aged 18 years at screening were enrolled. Participants were required to meet all eligibility criteria prior to randomization into the study.
738179|NCT01275586||
738180|NCT01275430||
738181|NCT01275365||
738182|NCT01275339||
738183|NCT01275313||
738184|NCT01275300||
738185|NCT01275196||Patients were randomized 1:1 between Nilotinib and Imatinib.
738186|NCT01275170|Participants with varying degrees of renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (HD) [based on estimated glomerular filtration rate (eGFR)], or healthy matched controls were enrolled at 2 study sites in the United States.|All panels participated in Part 1 of the study. Panels E to H also participated in Part 2 of the study.
738187|NCT01275144||
738188|NCT01275131||
738189|NCT01275092|During January-December 2011 period 164 participants were enrolled in the PRECISE study at 9 clinical sites|
738190|NCT01275066||
738191|NCT01275053||
738192|NCT01274897|Participants were enrolled at 8 centres in the Korea.|All enrolled subjects were included in the trial.
738193|NCT01274715|The recruitment period lasted from January 2011 through July 2011. After patients were screened, recruitment occurred over the phone, where they gave audio consent to participate in the study.|Three participants who gave consent to participate in the study met exclusion criteria at baseline and were removed from the study before being assigned to the intervention.
738194|NCT01274637|Potential subjects were initially approached by a member of the health care team providing their care (physician, nurse, care facilitator, etc.). If the patient agreed to being contacted, the Investigator or designate provided detailed information regarding the study and assessed the individual's eligibility for the study.|
738625|NCT01251861|This study was activated on December 23, 2010 and closed to accrual on September 20, 2013 with a final accrual of 108 patients from 24 participating sites.|
738195|NCT01274611|Patients were recruited from an urban, university based dermatology practice (Northwestern University, Chicago, IL) and the surrounding community. All patients provided written informed consent.|This was a split body, parallel-group randomized control trial with allocation ratio 1:1, using random block size of 2. The unit of randomization was the individual axilla.
738196|NCT01274585||
738197|NCT01274559||Phase 3 study HPS2-THRIVE (NCT00461630) did not meet its primary endpoint of reduction of major vascular events and had a significant increase in the incidence of some types of non-fatal serious adverse events. As a result, MK-0524A-133 was discontinued. Only individual data were obtained; none of the planned efficacy outcomes were summarized.
738198|NCT01274533|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.|
738199|NCT01274520|24 liver recipients who received extended criteria donor (ECD) liver transplant allografts were recruited for our treatment group over a span of 2 years. As a high-volume, major NY transplant center with approximately 270 adult patients on our Liver Transplant Waiting List and 45-50% receiving ECD grafts, we were able to meet our enrollment goal.|
738200|NCT01274429||
738201|NCT01274351|A total of 112 participants were enrolled into the study from the 15 sites in Turkey.|This was an open-label study with one treatment arm. The study did not involve a reference treatment.
738202|NCT01274182||
738203|NCT01273896||
738204|NCT01273883||
738205|NCT01273857||
738206|NCT01273818|Recruitment period begins in Jan 2011. This period will be completed when record of minimum number participants ( according to power analysis) in each arm is completed.Location is surgery clinic of our hospital.|Totaly, 24 patients who were known using any kind of antibiotics for any reason just prior to surgery or just after the surgery and having history of allergic reactions to antibiotics used in this study were excluded.
738207|NCT01273805|20 participants were enrolled between January 2011 and October 2012.|
738208|NCT01273766||
738209|NCT01273623||
738210|NCT01273597||
738211|NCT01273519||
738212|NCT01273207|The lung transplant arm was closed during the study due to lack of subject enrollment|
738213|NCT01273181||Ph I:study will begin by evaluating the safety of 2 ranges of cells,5x10^9-3x10^10, & >3x10^10-1x10^11 in a standard ph I dose escalation using a 3+3 design. Ph II:pts will be entered into 2 cohorts based on histology:cohort 1 will include pts with metastatic melanoma or RCC; cohort 2 will include pts with other types of metastatic cancer.
738214|NCT01273155||
738215|NCT01273064||
738216|NCT01273038|Subjects were recruited from a user database in Denmark|20 subjects were enrolled and randomized in the study
738217|NCT01272999||This study is a 3-year prospective laboratory-based surveillance study wherein the results of the samples obtained were summarized separately for each year. In this study, no more than 1 sample was obtained from a participant and no more than 1 serotype was isolated from any sample.
738218|NCT01272960||53 participants were enrolled but only 29 randomized.
738219|NCT01272947||
738220|NCT01272934|Study Start 18 January 2011 Study end 23 August 2011|
738221|NCT01272921|Subjects undergoing primary tricompartmental total knee replacement at Northwestern Memorial Hospital were asked to participate. 174 patients were approached. 142 subjects were recruited to participate.|Exclusion criteria: subject refusal to be included in the study, contraindications to regional anesthesia, inability to elicit an evoked motor response less than or equal to 1 mA, history of allergy to amide local anesthetics, presence of a progressive neurological deficit, opioid tolerant subjects, presence of coagulopathy, infection, or pregnancy
738222|NCT01272908||
738223|NCT01272882|Intensive care units|No pre-assignment details to note.
738224|NCT01272869|The subjects were recruited from a user data base in Denmark.|20 subjects were enrolled and randomized in the study.
738225|NCT01272830|A total of 57 subjects were consented to participate.|"Following consenting, 6 subjects did not meet the study inclusion/exclusion criteria, thus never received the study drug.
~1 - Abnormal Liver Panel: very low Hemoglobin/Hematocrit levels
~1 - Glucose-6-phosphate dehydrogenase (G6PD) deficiency
~3 - X-rays revealed loose or mal-positioned component(s)
~1 - Prescribed steroids prior to study drug"
738226|NCT01272804||
738227|NCT01272661||
738228|NCT01272635||
738229|NCT01272583|Participants came to the Academic Medical Center in Amsterdam for a screening visit to determine eligibility for the study.|Patients were excluded if they were found to have impaired awareness of hypoglycaemia, had a history of seizures, cardiac arrhythmia (or used beta-adrenoreceptor blockers) and/or acute infection in the 12 weeks before the study, or evidence of severe diabetes complications (autonomic neuropathy, nephropathy or proliferative retinopathy).
738230|NCT01272388||
738231|NCT01272284|Women with documented stress urinary incontinence (SUI) who met enrollment criteria|
738232|NCT01272245|Recruitment Period: 7/14/2011through 1/9/2015. All participants recruited at The University of Texas MD Anderson Cancer Center.|
738233|NCT01272232|A total of 126 sites in 9 countries participated: France (7), Germany (10), Israel (5), South Africa (6), Spain (8), Sweden (5), Turkey (3), United Kingdom (15), United States (67).|If eligible based on screened assessments, subjects were randomised to 1 of the 3 treatment arms in a 2:1:1 manner (liraglutide 3.0 mg, liraglutide 1.8 mg and placebo, respectively).
738234|NCT01272219|The trial was conducted at 191 sites in 27 countries: Australia:4,Austria:3,Belgium:2, Brazil:5,Canada:11, Denmark:3,Finland:3, France:5, Germany:8,Hong Kong:1, Hungary:2, India:8, Ireland:1,Israel:7, Italy:7, Mexico:4, Netherlands:5, Norway:3, Poland:5, Russian:7, Serbia:2, South Africa:3, Spain:6, Switzerland:5,Turkey:4, UK:8, US:69.|Subjects were stratified based on pre-diabetes status and BMI at screening. The Main Period table, below, reflects the stratification that should have occurred at baseline. The Re-randomized Period and Main + Extension Period tables reflect the actual distribution of subjects, factoring in an incorrect stratification of 43 subjects at screening.
738626|NCT01251770||
738627|NCT01251757||
738235|NCT01272193|The trial was conducted at 48 sites in Japan.|Subjects continued on not more than 2 oral antidiabetic drugs (excluding sulphonylureas/dipeptyl peptidase-4 [DPP-4] inhibitors/glinides) at the pre-randomisation dose level and dosing frequency.
738236|NCT01272180||All enrolled subjects were included in the trial.
738237|NCT01272141||
738238|NCT01272076|85 subjects were enrolled between 1/10/2011 - 2/25/2011. The study was conducted at Retina Specialist clinics.|After enrollment a screening image of the retina is done to ensure that the area of Geographic Atrophy is consistent with the inclusion criteria. We enrolled 85 subjects, however, 19 were determined not to be eligible per study protocol. In addition, images of 14 subjects did not meet predetermined qualification criteria per study protocol.
738239|NCT01272011|Recruitment occurred from October, 2010 through April, 2014 through the North Florida/South Georgia VA Medical Center's Brain Rehabilitation Research Center.|Different study arms were carried out in different phases. The time individuals were enrolled determined which arm they were involved with. Participants enrolling knew which arm we currently were recruiting for. Individuals enrolled in early arms were invited back to other arms of the study if they chose--however, this was not a requirement.
738240|NCT01271946|Enrollment commenced November 3, 2010 and concluded June 3, 2011. Patients who underwent routine diagnostic catheterization through 5 or 6F sheaths were enrolled in the study at 8 investigational sites in the US.|Patients were required to be able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
738241|NCT01271933|The study was performed in 4 countries at 50 centers.|Baseline phase was from Visit 1 to Visit 2. Eligible participants entered single blind (SB) phase (Visit 2 to Visit 6) [6 weeks]. Responders with at least 50% improvement in pain from baseline at the end of SB phase were considered for double blind (DB) phase (Visit 6 to Visit 9) [13 weeks]. All subjects entered 1 week taper phase after completion.
738242|NCT01271907||Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.
738243|NCT01271868||
738244|NCT01271855|For this study, participants were recruited between August 1, 2009 and October 1, 2011 (26 months)|
738245|NCT01271803|"Study included two stages. Stage 1: dose escalation stage (DES), consisted of 9 Cobimetinib + Vemurafenib combination arms and 1 Cobimetinib monotherapy. Stage 2: cohort expansion stage (CES), consisted of 2 Cobimetinib + Vemurafenib combination arms, treated with recommended phase 2 dose."|Participants data were pooled across dose/regimen cohorts from two stages and analyzed separately per final analysis for vemurafenib-PD and BRAFi-naive participants who received cobimetinib and vemurafenib. Data is presented based on the final CSR. As of 2017 per-cohort data were not collected
738246|NCT01271725|An open-label, multinational, phase-II trial of Afatinib (BIBW 2992) in patients with metastatic human epidermal growth factor receptor (HER2) - overexpressing breast cancer failing HER2 - targeted treatment in the neoadjuvant and/or adjuvant treatment setting|"All subjects were screened for eligibility. It was not planned to compare efficacy of the combination therapies Afatinib and Paclitaxel or Afatinib and Vinorelbine as the study was stopped prematurely and the patient number in both treatment groups is not significant. However, for safety reporting both combination therapy are reported separately"
738247|NCT01271712|A total of 240 participants with metastatic and/or unresectable GIST whose disease had progressed despite prior treatments with at least imatinib and sunitinib were screened; 199 were randomized. Patients must have shown objective disease progression or intolerance to imatinib, as well as disease progression while on sunitinib treatment.|Participants were randomized in a 2:1 ratio to receive either regorafenib (133 patients) or placebo (66 patients). Randomization was stratified according 3rd vs. 4th line of therapy (at least 50% of patients were to be 3rd line), and geographical region (Asia vs.rest of world).
738248|NCT01271686|Experimental subjects were recruited consecutively from patients with diagnosed bilateral primary open angle glaucoma or ocular hypertension at the Hamilton Glaucoma Center of the University of California, San Diego.|Subjects who smoked, had previous glaucoma surgery in either eye, had a history of ocular trauma or a sleep disorder, or had an irregular sleep schedule were excluded.
738249|NCT01271543|The study was performed at Penn State Milton S. Hershey Medical Center|No events
738250|NCT01271452||
738251|NCT01271413||
738252|NCT01271244||
738253|NCT01271036||Only one IP was used per couple in this single-arm study. At baseline (visit 1), all qualified subjects received the IP for use per protocol.
738254|NCT01271010||
738255|NCT01270971|Subjects were screened and enrolled at thirty-four investigative centers in the United States and Mexico. The study population included men and women, 18 years of age and older who had distal subungual onychomycosis. The first subject visit occurred on December 1, 2010, and the last subject completed the Post Study Follow Up on January 8, 2013.|Eligible subjects were randomized in a 2:1 ratio to receive AN2690 Topical Solution, 5% or Solution Vehicle to be applied once daily to all affected toenails throughout the 48-week treatment period.
738256|NCT01270958||
738257|NCT01270919||
738258|NCT01270880||
738259|NCT01270867||
738260|NCT01270841||
738261|NCT01270828|A total of 129 centers in 17 countries screened subjects for the study, including 68 in the US, 6 in Bulgaria, 6 in Poland, 6 in Russia, 6 in the Ukraine, 5 in India, 5 in South Africa, 5 in Sweden, 4 in Slovakia, 3 in Colombia, 3 in Croatia, 3 in Germany, 2 in Denmark, 2 in Hong Kong, 2 in Serbia, 2 in Taiwan, and 1 in the Czech Republic.|The study consisted of 4 phases: Baseline (1 week [wk]): to determine study entry criteria; Single Blind (SB) (6 wks): to determine optimized dose; Double Blind (DB) (13 wks): responders with at least 50% improvement in pain at SB were considered and randomized to pregabalin or matching placebo; and DB taper phase (1 wk).
738262|NCT01270802|Enrollment into this trial occurred between April 2011 and May 2012. Participants were recruited from the HIV outpatient clinics associated with the Indiana University Health medical system.|Thirty-two persons screened for enrollment. Two of these failed screening (both for having screening HIV-1 RNA levels >50 copies/mL); the remaining 30 were equally randomized into the two study groups.
738388|NCT01263483|Participants enrolled at investigative sites in Japan from to .|Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 3, once-daily (QD) or three-times daily (TID) treatment groups.
738691|NCT01248364||
738263|NCT01270711|Part 1 recruited participants from North, Middle and South Europe and Part 2 from specialized clinical centers in Italy.|Part 1 assessed adherence (compliance) with prescribing guidelines (PG) by using automated health care data which had information on strength, indication, referrals for echocardiography, recognized reputation in area of drug utilization, safety research. Part 2 assessed effectiveness of PG for cabergoline in participants with Parkinson's disease.
738264|NCT01270659||
738265|NCT01270620|One hundred patients provided consented to participate in the study during June 2010 to August 2014.|
738266|NCT01270581|The NICU fellow on service, or on call, will identify all NICU admission that are potentially eligible for participation. Parents of potentially eligible subjects will be approached by a member of the NICU team to discuss study participation within 4 hours of admission to the NICU.|
738267|NCT01270555||
738268|NCT01270542||
738269|NCT01270529||
738270|NCT01270503|The study participants were enrolled from 16 December 2010 through 15 November 2012 at 130 clinic centers in thePhillipines|A total of 538 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
738271|NCT01270464||Of the 1025 patients screened at 80 centers in 12 countries (Argentina, Belgium, Brazil, Canada, Colombia, Hungary, Israel, Mexico, Netherlands, Poland, Sweden, and the US), 315 patients met entry criteria at 68 centers and were considered to be eligible for enrollment.
738272|NCT01270321|Patients were enrolled between 11/17/2010 and 1/2/2019 at Winship Cancer Institute of Emory University|
738273|NCT01270256||
738274|NCT01270139|This trial was a multi-centre (two sites), observational, open-label, three arms study in 180 patients with CAD and angiographic SYNTAX score ≤22. The project started in April, 2007 and completed in June, 2012.|Some patients were excluded from the per-treatment-evaluable population since they received a stent or were treated with CABG as an event of target lesion revascularization (TLR). Patients were also excluded in case of non-compliance or documented while the ongoing trial the first arose diabetes, NYHA IV functional class of HF, or SYNTAX score ≥23.
738275|NCT01270126|"Assessed for eligibility (n=325)from local institutional database and upon response on announcements in local newspapers from Nov 2006 - Dec 2008.
~Excluded (n=303): not meeting inclusion criteria (n=248), declined to participate (n=40), other reasons (n=15)"|
738276|NCT01269918||
738277|NCT01269801||"Subjects were randomized to two groups: Juvederm first, then Botox (Juvederm group) or Botox first, then Juvederm (Botox group).
~For the Juvederm group, Day 1 involved juvederm treatment. Week 4 involved botox administration.
~For the Botox group, Day 1 involved botox treatment. Week 4 involved juvederm administration."
738278|NCT01269749||
738279|NCT01269736|In addition to the nurses and patients consented in each hospital, 95,884 hospital admission records were reviewed for patient outcomes, representing 84,392 unique patients from 13 hospitals.|Hospitals were the unit of randomization, nurses received ECG education in each hospital. Outcomes were assessed in nurses and the patients cared for on the participating units.
738280|NCT01269710|Subjects will be recruited from outpatient child psychiatry programs (including community clinics, school based mental health programs, private practices), inpatient psychiatry units and community outreach efforts.|Treatment of subjects enrolled in this study will be determined by their clinician and will remain unaffected by participation in this observational minimal risk study.
738281|NCT01269385||
738282|NCT01269372||
738283|NCT01269346||A total of 64 participants were screened for entry into the study, of these participants 12 were screen failures and 52 were enrolled into the study and received at least one dose of study treatment.
738284|NCT01269125|This prospective, randomized study with control group was carried out at the Department of Obstetrics and Gynecology, Ioannina University School of Medicine (Ioannina, Greece)during a 7-years period (May 2004 to September 2010).|"Assessed for eligibility (n= 570) Excluded (n= 390)
~Not meeting inclusion criteria (n= 102)
~Declined to participate; underwent expectant management or IUI (n= 253)
~Other reasons; lost to follow up (n=35)"
738285|NCT01269047|37 participants were screened. Recruitment began at Baylor College of Medicine, TX in August of 2009 and the last study visit was in July of 2012 at Montefiore Medical Center, Bronx, NY|
738286|NCT01268943|Between October 2010 and November 2013, 18 patients were enrolled in a hospital.|
738287|NCT01268891||The study consisted of a 2-week Screening Period during which the levodopa dose was optimised (if required), a 2-week Screening Period during which the levodopa dose was stabilised, an 18-week double-blind treatment period with rasagiline or placebo once daily (patients were randomised in a 1:1 ratio), and a 4-week Safety Follow-up Period.
738288|NCT01268683|Between February 2011, and May 2012, ten subjects were enrolled and treated at University of Maryland and the Massachusetts General Hospital within 9.6 months at 2 sites.|
738289|NCT01268644|Patients with T1DM between the 18 and 50 years of age and with a BMI less than 27 kg/m2 and an HbA1c of 7.0-10.0% (53-86 mmol/mol) were eligible for the study.|
738290|NCT01268566|A total of 56 subjects were enrolled and treated at 13 sites in the United States.|A total of 62 participants were screened. Of which, 56 participants were enrolled into study as 5 participants failed screening and 1 participant withdrew consent.
738291|NCT01268553||
738292|NCT01268514|115 patients were enrolled at 12 sites in 5 European countries.|"All subjects undergoing planned surgical treatment for complex abdominal wall repair with Permacol implantation and who agree to 36 months of follow-up.
~The study allowed inclusion of up to 200 subjects at up to 20 sites."
738293|NCT01268501|A total of 103 participants were recruited at 25 US sites from December 8, 2010, to January 31, 2011.|Seven participants were enrolled in the study but not dispensed due to failing inclusion/exclusion criteria (1); withdrawing consent/disinterest (4); discomfort (1); and unacceptable subjective vision (1). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
738294|NCT01268488||
738295|NCT01268306|Subjects randomly recruited from contact lens wearing population in an optometric practice|Patients with spherical contact lens corrections who achieved acceptable acuity with test lenses were offered study participation.
738296|NCT01268293||
738297|NCT01268267||
738298|NCT01268189||
738299|NCT01268150||
738300|NCT01268111||
738301|NCT01268098|42 Subjects enrolled between 2/2011 and 9/2011 at 11 sites in the US.|Subjects who completed 24 wks of treatment and 4 wks follow-up in the REPLACE Study (NCT00732615) or received 2 single doses in Phase I Study C09-002 followed by a 4-wk washout, or enrolled in the REPLACE Study and entered into the optimization phase, but were not randomized due to the close of randomization; or were new to the NPSP558 program.
738302|NCT01268059||Overall, 99 participants were enrolled in the study, (4 participants, all from North America sites, were enrolled in the Phase 1b part of the study and 95 participants in Phase 2 part of the study). Of 95 participants, 14 were enrolled from Japan sites, and 81 were from North American and European Union (EU) sites.
738303|NCT01268046||
738304|NCT01267994||
738305|NCT01267955||
738306|NCT01267929|The children were recruited from Thammasat University hospital and Rajanukul institute. Study period was two years which started from September 2009 to October 2011.|Thirty two children were assessed for their eligibility to participate in the study. One were excluded for failing to meet the inclusion criteria. One parent of a child refused to participate in the study.
738307|NCT01267864||
738308|NCT01267825||
738309|NCT01267656|There were 168 participants enrolled and 166 participants treated. The study was a cross-over study, so the 166 participants received both treatment groups.|
738310|NCT01267422|Patients diagnosed with LHON (with a verified point mutation at the 11778 nucleotide site)|All patients were administered rAAV2-ND4 by intravitreal injection to one eye and then followed for 36 months.
738311|NCT01267292||
738312|NCT01267279||
738313|NCT01267266||
738314|NCT01267253||
738315|NCT01267240||
738316|NCT01267227|Medical clinic|
738317|NCT01267201||
738318|NCT01267175||
738319|NCT01267136|The study was introduced to 137 potential subjects during or following an outpatient office evaluation with an ear/nose/throat (ENT) surgeon between February 2011 and May 2012.|The study was introduced to 137 potential subjects, and 84 children were enrolled in the study and assigned to one of the two study arms.
738320|NCT01267045||
738321|NCT01267019||
738322|NCT01266993|"Out of 282 subjects participating to the study, 271 participated to Month 32-44 period, 261 to Month 44-56, 260 to Month 56-68, and 282 to Month 68-69 booster period.
~Out of 282 subjects participating to Month 68-69 booster period, 41 subjects had a subject number allocated but received no vaccine dose, hence only 241 started this phase."|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
738323|NCT01266967||
738324|NCT01266876|The study was conducted at 16 centers in the United States of America and Canada. Overall, 118 participants were screened between January 2011 and June 2011.|Randomization was stratified by concomitant use of ezetimibe (Yes/No). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1 ratio after confirmation of selection criteria. 77 participants were randomized.
738325|NCT01266850|Participants were healthy males and females age 6-14 weeks, recruited from the communities at large around the clinical sites. Participants were enrolled and vaccinated between 24MAR2011 and 08APR2013.|
738326|NCT01266824|Recruitment for this study was terminated due to poor enrollment.|
738327|NCT01266603||
738328|NCT01266590||
738329|NCT01266460|GOG-0265 enrolled 54 patients from May 23, 2011 to September of 2015. Of the 54 patients enrolled, 50 patients received treatment.|
738330|NCT01266447|The study was activated on 2/7/2011 and closed to accrual on 1/17/2013.|
738331|NCT01266317||
738332|NCT01266291|Subjects were recruited for the treatment arm from within the Tuberous Sclerosis (TS) clinical at the University of Pennsylvania. Recruitment begain on 8/19/2010 and continued through 2013. All potential subjects had to be eligible to take Sabril (vigabatrin) under the FDA-approved prescribing information.|Before taking Sabril, subjects were required to undergo visual field and depression screenings in response to the FDA's black box warning about Sabril causing vision loss, and an increased risk of suicidal ideation among patients taking antiepileptic drugs like Sabril. No potential subjects were excluded due to screening assessments.
738333|NCT01266265|The recruitment period for this study was February 2010 to December 2014. All sites were located in the United States.|
738334|NCT01266161||
738335|NCT01266148|115 patients (56 in the everolimus group, 59 in the control group) were randomized and received study treatment.|"Group A (control) received treatment with Cyclosporine A (CsA), Mycophenolate mofetil (MMF), and corticosteroids.
~Group B (everolimus), received: low-dose CsA and everolimus, reduced dose MMF, and corticosteroids.
~After week 7-11, CsA was discontinued in Group B, while the standard triple-drug immunosuppressive regimen was maintained in Group A."
738336|NCT01266122||
738337|NCT01266070|Recruitment Period: November 16, 2012 to January 30, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.|
738338|NCT01266031|Recruitment Period: the study was initially written in 2010 and eventually activated at the lead site on 7/6/2011.|
738339|NCT01266018||
738340|NCT01265992||
738341|NCT01265966|All patients were recruited over a 7 month period from the Tripler Army Medical Center Pediatric Sedation Center.|149 patients were recruited. 117 had samples adequate for analysis. 7 patients were on inhaled and/or intranasal steroids, and were analyzed separately. Therefore 110 were included in the main analysis.
738342|NCT01265953||
738343|NCT01265875||
738344|NCT01265823||A total of 187 participants were screened and 37 were considered screening failures.
738345|NCT01265797|Recruitment dates: Dec 2010 - Jan 2013 Recruitment status: Not enrolling. Location: Neurology Clinic|Enrolled participants were randomized to receive verum or sham intervention. Completion of one (run-in) month headache diary was required before obtaining device.
738346|NCT01265784||Randomization was stratified by site of infection (complicated appendicitis versus all other diagnoses).
738457|NCT01260142||Each cohort had 2 treatment periods that were separated by a 7 to 14 day washout: fospropofol disodium, followed by propofol injectable emulsion; or propofol injectable emulsion, followed by fospropofol disodium.
738347|NCT01265719|A total of 175 patients were enrolled into the study in 14 countries in Europe and South America: 102 in the latanoprost treatment group and 73 in the non-Prostaglandin (PG) treatment group.|No significant events prior to group assignment are to be reported. This was a non-interventional, prospective, longitudinal cohort study. Pediatric patients with glaucoma or elevated intra ocular pressure (IOP) were enrolled into 2 groups: Latanoprost-treated patients and non-PG treated patients.
738348|NCT01265667||
738349|NCT01265615|A total of 120 patients (Russian and dutch caucasian, kidney recipients with vitamin D deficiency defined as 25(OH)D < 30 ng/mL) were assigned on the basis of Ural Institute of Cardiology. Nine of the 120 patients were subsequently excluded due to protocol violation. All the patients had given their written informed consents.|
738350|NCT01265563|213 subjects met the inclusion criteria on screening from 2 clinic locations: VA and University Hospital Renal clinics.Many had exclusion criteria and few refused to participate. 108 subjects finally enrolled in the study.|During Run-in phase before randomization to the experimental arms, 4 subjects were excluded due to hospitalization for various reasons and 26 were excluded due to issues with transportation or sickness in the family or themselves.
738351|NCT01265550||
738352|NCT01265537||
738353|NCT01265524||Although 113 subjects were randomized, 2 subjects did not receive study drug and were removed from the analysis as pre- specified in the SAP.
738354|NCT01265511||
738355|NCT01265498||
738356|NCT01265459||
738357|NCT01265446|14 Dec 2010 to 5 Apr 2011|
738358|NCT01265420||
738359|NCT01265394||
738360|NCT01265056|Recruitment period 1/2010 to 9/13/2011. Patients were recruited for the study if they met criteria and were admitted for burn injuries.|There were no significant events or approaches following enrollment. Patients were randomized into groups.
738361|NCT01264965||
738362|NCT01264952||
738363|NCT01264939||"Randomized population: All randomized participants regardless of whether they received any study drug.
~One patient in the placebo group was withdrawn after randomization but before receiving treatment due to an adverse event. This patient is 1 of 18 in this reporting group who did not complete the study."
738364|NCT01264887|First participant was enrolled on the 03 March 2011 and the last participant completed the trial on the 08 May 2014.|
738365|NCT01264835||
738366|NCT01264770|452 patients were enrolled into the main study, with 198 patients enrolled into a separate MRI sub-study. Synovitis results for the MRI sub-study were reported later due to study delays and so are presented entirely separately.|A total of 173 patients failed screening to the main study.
738367|NCT01264718||
738368|NCT01264705||
738369|NCT01264679||
738370|NCT01264614|Early stage dementia participants were drawn from the Adult Day Care Program (ADCP) at a Veterans Affairs Medical Center (VAMC) in the northeast United States. Normative older adult participants were either employees or volunteers at the same facility recruited by fliers.|
738371|NCT01264601|This study was conducted from October 2010 through March 2012 at the University of Michigan.|After informed consent process, parents filled out a questionnaire, detailing their child's history of past reactions to the ingestion of egg and any prior influenza vaccines. This information was verified by medical record review. In addition, the most recent egg skin test and serum egg protein specific IgE were also obtained.
738372|NCT01264419|Between March 2009 and June 2012 a total of 99 patients were approached about participating in the study. The majority of these individuals (86) were patients of Augusta Krankenhaus in Dusseldorf, Germany, and 13 were patients of the second site, Lukas Krankenhaus, in Neuss, Germany. Study treatment was attempted in 75 study subjects.|All enrolled participants were assigned to the single arm.
738373|NCT01264380||
738374|NCT01264081||Thirty participants were registered, tested for the ERBB4 mutation, and taken off study as screening failures as they did not have the ERBB4 mutation to be treated with Lapatinib.
738375|NCT01264016||
738376|NCT01263938|Subjects were recruited from the AIDS Clinical Trial Unit (ACTU) at the Hospital of University Of Pennsylvania, Philadelphia, PA. The screening and recruitment process was carried out during the period September 2011 thru April 2012.|Enrolled participants were assigned to treatment groups based on the nature of HAART therapy (PI- or non-PI based).
738377|NCT01263925|Of the 607 screened subjects, 561 have been randomized. Of these 561 randomized subjects, 541 are included in the Full Analysis Set (FAS). FAS includes all randomized subjects who received at least one dose of trial medication and who have at least one valid measurement of pain-free walking distance under therapy.|Participant Flow shows all randomized subjects. Baseline Characteristics refer to the FAS.
738378|NCT01263873|October, 2010 through January, 2011 in operative room.|
738379|NCT01263782|Twenty-four patients with non-small cell lung cancer were recruited from June 2011 to October 2013 at the University of Texas MD Anderson Cancer Center.|The patients had pre-treatment evaluations, which were used to determine the patients' study eligibility, within 4 weeks prior to initiating therapy. Out of 64 participants, 40 was screen failed.
738380|NCT01263717||
738381|NCT01263704||
738382|NCT01263691|Participants were enrolled from 27 December 2010 to 08 March 2012 at three medical centers in the U.S.|All 105 enrolled participants who met inclusion and exclusion criteria were dosed.
738383|NCT01263665||
738384|NCT01263639|January 2011 to December 2011. All patients were admitted from the ER to the orthopaedic trauma service and had operative injuries requiring surgery on the same admission.|
738385|NCT01263561||
738386|NCT01263509|Participants enrolled at 24 investigative sites in Japan from 06 June 2007 to 02 October 2008.|Participants enrolled in one of 2, once-daily (QD) or three-times daily (TID) treatment groups. Analyses performed by treatment group or treatment dose in this study. All 213 participants randomized in the phase 2/3 α-glucosidase inhibitor (NCT01263483) study are included in the Full Analysis Set in this study, of which 179 randomized.
738387|NCT01263496|Participants enrolled at 53 investigative sites in Japan from 10 May 2007 to 27 September 2008.|"Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 5, once-daily (QD) or three-times daily (TID) treatment groups.
~Analyses were performed by treatment dose group or by treatment dose in this study."
738389|NCT01263470|Participants enrolled at 54 investigative sites in Japan from 17 January 2007 to 22 December 2007.|Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 6, once-daily (QD) or three-times daily (TID) treatment groups.
738390|NCT01263444|Participants were recruited from 3 study centers located in Austria and 2 study centers located in Spain.|This reporting group includes all enrolled participants (47).
738391|NCT01263314||All participants will receive at least 2 doses of MK-8266. Participants completing placebo treatment in Period 1 will flow to the MK-8266 arm in the next period, with 2 participants from the MK-8266 arm receiving placebo in the next period.
738392|NCT01263301|enroll patients from Dec 2010 to July 2011. all enrolled patients have been studied by carotid duplex in Mennonite Christian hospital.|one patient with vascular access has been ruled out after enrollment for the subclavian artery revealed normal blood flow in duplex.
738393|NCT01263223||
738394|NCT01263197||This was a 3-period, crossover study conducted in 2 groups. Participants were randomized to 1 of 3 sequences in either the albuterol group (Group 1) or 1 of 3 sequences in the propranolol group (Group 2).
738395|NCT01263132||A total of 104 participants were recruited for the study, out of which 29 participants were screen failures which were not randomized and did not receive study treatment.
738396|NCT01263119||
738397|NCT01263106||
738398|NCT01263093||
738399|NCT01263054||In this study, 67 subjects were randomized, with 63/67 being treated. Three of the non-treated subjects had exclusion criteria violations, while the fourth subject was not treated for an undisclosed reason. The disposition of subjects in the Participant Flow summary is with respect to the primary outcome.
738400|NCT01263028|Recruitment began in February 2011 at Kaiser Permanente Los Angeles Medical Center. Despite strong enrollment efforts only 6 particiants were enrolled out of 10 screened.|Participants were assessed for study inclusion based on chronic kidney disease (CKD) stage, age, current vitamin D levels <30 ng/ml as well as history of vitamin D levels < 30, and stable dose of erythropoietin and iron.
738401|NCT01263015|Study consisted of 96 weeks double-blind phase, followed by a 48 week open-label phase.|A total of 844 participants (par.) were randomized (1:1) to one of the two treatment arms. Of these, 833 par. received at least one dose of study medication. Of the 11 par. who were randomized but not treated with investigational product, 7 par. withdrew consent, 3 par. were randomized in error, and 1 par. was lost to follow-up.
738402|NCT01262989||
738403|NCT01262976||
738404|NCT01262898|A total of 80 participants were enrolled and randomized from 03 May 2011 to 26 Feb 2013. The study was conducted at 22 centers, 1 center in Australia, 1 center in Sweden, 2 centers in Belgium, 4 centers in Canada, 5 Centers in United Kingdom and 9 centers in United States.|"Out of 80 participants randomized, 1 participant withdrew consent prior to dosing in GSK962040 50 milligram (mg) arm. Remaining 79 participants were included in All subject population"
738405|NCT01262872|Cohort 1 subjects participated in Step 1 (duration of about 6 months). Cohort 2 subjects participated in Step 2 (duration of about 10 months). Enrolment for Step 2 was conditional upon successful results of a post-vaccination safety evaluation of all children enrolled in Cohort 1 by an Independent Data Monitoring Committee.|Description of any significant events and approaches for the overall study following participant enrollment, but prior to group assignment.
738406|NCT01262846||
738407|NCT01262820|Subjects were recruited between April 2010 and January 2014|A total of 22 patients provided informed consent for this trial; 7 patients were considered ineligible leaving 15 patients who enrolled and were treated on study.
738408|NCT01262755||
738409|NCT01262677|This was a multicenter, multinational study and included four standard phases: an 8-week baseline observation phase, a 2-week dose escalation phase, a 12-week fixed-dose maintenance phase, and a 1-week taper phase.|An 8-week baseline observation phase began immediately after the screening visit. Througout the observation phase the participants continued their current anti-epileptic drugs (AEDs) at the prescribed dosage, eligibility was re-evaluated at Week -4 and Week 0, and the participants recorded all seizures in daily seizure diaries.
738410|NCT01262651||Per the Statistical Analyses Plan, all randomized participants who received at least 1 dose of study drug were analyzed in the Intent-to-Treat (ITT) population as per randomized treatment group. However, if a participant randomized to placebo ever took a nabiximols dose, the participant was analyzed as nabiximols-treated in the Safety population.
738411|NCT01262599|Recruited from medical offices of two participating plastic surgeons.|
738412|NCT01262573||
738413|NCT01262560||
738414|NCT01262547||
738415|NCT01262456||A total of 1013 participants were screened; 618 were screening failures and 395 were randomized. The most common reason for screening failure was non-fulfillment of inclusion/exclusion criteria (535 participants); 23 participants withdrew consent prior to randomization and 60 participants had other reasons for screening failure.
738416|NCT01262365|The study started to enroll patients in December 2010 and concluded in May 2015.|Participant Flow refers to the Randomized Set (RS).
738417|NCT01262352|The study started on 14 February 2011 (signing of first informed consent). After obtaining informed consent and assent (where applicable), screening evaluations were completed at any time during the period 10 to 18 days (Days -18 to -10) before first dose of study drug (Day 1).|A total of 21 subjects were randomized; 20 subjects received at least 1 dose of the study drug.
738418|NCT01262339||
738419|NCT01262287||4 subjects excluded during screening due to medical or laboratory exclusion (n=3) or current drug dependence (n=1); 4 subjects lost interest in participation following screening and prior to randomization to treatment arm resulting in 37 subjects available for randomization to treatment arm
738420|NCT01262131||
738421|NCT01262118||
738422|NCT01262105||
738454|NCT01260272|Recruitment for this study started around Dec 2010 and ended around April 2011. Subjects were selected from the PI's contact database and from advertisements|Subjects completed a 2-4 week screening period, during which labs and medical records were reviewed to verify eligibility
738455|NCT01260194||
738456|NCT01260181||
738458|NCT01259869||
738459|NCT01259856|Enrollment period from Sept 2011 through June 2016|
738423|NCT01262092|Thirty treatment-seeking opioid-dependent individuals were recruited from Central Arkansas by ads, word-of-mouth and referrals in October 2010 and January 2011-December of 2011. An experienced research staff member obtained informed consent interviewed subjects in a private office on the 4th floor of the Psychiatric Research Institute.|On Tuesday of Week 1, participants were randomized into treatment groups based on withdrawal symptoms score, sex and primary opioid of abuse using an urn randomization procedure. This was done to ensure that groups are balanced with respect to potential prognostic factors.
738424|NCT01262027|Recruitment Period: January 27, 2012 to July 29, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.|
738425|NCT01261975|This study was conducted at one clinical site in Europe. First participant was enrolled on 8/25/2009 and last participant exited the study on 4/27/2010. Study lasted six months for enrollment and three months for follow-up.|36 participants at least 50 years of age were enrolled in bilateral cataract surgery with phacoemulsification and intraocular lens implantation for the correction of aphakia. The Stellaris Vision Enhancement System was used for a 1.8mm Coaxial Micro-Incision procedure in one eye and a 2.75mm coaxial standard procedure in the contralateral eye.
738426|NCT01261819||
738427|NCT01261793|The study started to enroll patients in December 2010 and concluded in June 2015.|Participant Flow refers to the Randomized Set (RS).
738428|NCT01261780|This study enrolled patients from May 2011 through May 2012 at a large research university.|
738429|NCT01261624|Recruitment period: October 2010 - December 2011. The study was conducted by nine Investigators in five countries across Europe; three Investigators in Italy, two Investigators each in Romania and Serbia, and one Investigator each in Czech Republic and Slovenia|
738430|NCT01261611|Subjects recruited at 61 centres in Australia (2 subjects), Austria (9 subjects), Belgium (9 subjects), Czech Republic (58 subjects), France (31 subjects), Germany (38 subjects), Hungary (44 subjects), Poland (68 subjects), Portugal (12 subjects), Russia (36 subjects) and Ukraine (62 subjects).|382 subjects screened, 369 randomised due to 13 screen failures.
738431|NCT01261559|Recruitment: December 2010 to February 2012, at Harborview Medical Center (inpatient wards, outpatient clinics, and emergency departments)|"All women who were approached for the study were screened for exclusion criteria prior to enrollment.
~110 eligible patients were approached, and 37 declined participation or met exclusion criteria. 1 subject was scanned but TLD readings were clearly erroneous and were therefore excluded. 72 subjects were ultimately included in analyses."
738432|NCT01261507|Recruited by email 15 radiologists practicing in the DC Metro area. Used prior subjects and those referred by prior research subjects.|discussion of project was done with each participant. Any questions were answered and signed consent was obtained. There were no dropouts of those recruited.
738433|NCT01261390|Initial recruitment was limited to patients with sleep apnea identified through clinical sleep programs of Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Recruitment later expanded to include patients presenting to cardiology and diabetes clinics. Recruitment began on April 2011 and ended on June 2013.|Patients with no sleep study were provided a portable sleep monitor to measure the severity (if any) of obstructive sleep apnea (OSA). If tests shows moderate to severe OSA, patients were asked to wear a positive airway pressure (PAP) mask with no pressure for 2 weeks. Those with proven adherence during this time were scheduled for a baseline visit
738434|NCT01261338|Twenty-eight participants were recruited prior to April 2011.|Participants were randomized into groups of 14 each, to receive either olestra and vegetable oil.
738435|NCT01261325|Recruitment for the N01358 study began in December 2010. The study concluded in May 2014.|The Participant Flow and Baseline Demographics data is taken from the Randomized Set (RS). The RS consists of all subjects who were randomized.
738436|NCT01261247||
738437|NCT01261052|Subjects were recruited from the Greater Portland Oregon area and screened from Oct 2010 through January 2011 at a Legacy Health system clinic facility.|Each of the 14 subjects will participate in two artificial pancrease glucose control study interventions.
738438|NCT01261000||
738439|NCT01260948||
738440|NCT01260922||
738441|NCT01260896||
738442|NCT01260883|Infants less than 18 months of age, having surgery requiring inpatient admission, from 2001 through 2008, with normal renal and liver function, not on chronic medication , not prematurely born, were selected.|If screening lab studies (blood urea nitrogen [BUN], creatinine, liver transaminase concentrations, urinalysis) were abnormal infants were excluded. If postoperative concerns precluded blood sampling or if sampling intravenous (iv) catheters did not function, infants were excluded.Of 77 infants screened, 51 infants started study
738443|NCT01260701||
738444|NCT01260688|Study was open to recruitment on October 25, 2010 and closed to accrual on July 31, 2012. Study participants were identified in clinic. The target enrolment was 50 study participants; however only 22 participants enrolled as the study was terminated due to discontinuation of cediranib drug supply due to clinical development discontinuation.|
738445|NCT01260662|300 patients recruited in the Emergency Department from October 24, 2010 to February 4, 2013|271 enrolled subjects underwent procedural sedation
738446|NCT01260649||
738447|NCT01260584|Phase 4, double-blind, double-dummy, randomized, crossover study of male and female subjects with stable CAD, who are currently receiving aspirin and do not have contraindications for a thienopyridine.|Subjects will be stratified according to smoking status prior to being randomized to 1 of the 2 treatment sequences: prasugrel followed by clopidogrel or clopidogrel followed by prasugrel. There will be a 14-day Washout Period between Active Treatment Periods 1 and 2. All subjects will remain on the same dose of aspirin throughout the study.
738448|NCT01260493|recrutment period October 2008 to July 2011|exluded due to sheltered housing (n=2), dementia (n=1),palliative care (n=1) and died before baseline (n=4), declined particapation (n=12)
738449|NCT01260467||
738450|NCT01260454|"26 participants who were previously recruited for a study called SubQ works were screened for this study."|Of the 26 screened 10 had a pain score > or = 6 on two consecutive days. 6 of these 10 agreed to enroll.
738451|NCT01260350|Participants were enrolled in a total of 2 study sites in New Zealand. The first participant was screened on 18 November 2010. The last participant observation was on 23 December 2013.|
738452|NCT01260324||
738453|NCT01260311||
738460|NCT01259726|This study was conducted at a total of 44 investigative sites [United states (US)=33, Canada=4, and Europe=7], and 3 of the 33 US sites did not enroll any participants (each had 1 screen failure).|Of the 213 participants formally screened to participate in this study, 168 participants were treated. Five participants were randomized but not treated and 40 participants were screen failures.
738461|NCT01259713|Participants were enrolled at a total of 86 study sites. The first participant was screened on 13 April 2011. The last study visit occurred on 29 January 2014.|391 participants were screened.
738462|NCT01259596||
738463|NCT01259492||
738464|NCT01259466||
738465|NCT01259440||
738466|NCT01259427||Three participants were consented but indicated that they were unable to continue their participation prior to completing the baseline assessment. One participant was determined to be ineligible after randomization and was withdrawn from the study.
738467|NCT01259401|Veterans enrolled in the ADHC program for at least one month were screened for study eligibility criteria (i.e., the ability to understand screening items and to communicate during the screening process. If the individual was interested, written informed consent was obtained.|A total of 72 participants were enrolled into the study. After baseline assessment, 30 participants were not eligible for randomization: too cognitive impaired to participate (13); medical or behavioral issue (n=6); no longer met criteria for insomnia (n=3); discharged from ADHC (n=4); refused randomization (n=2); withdrew (n=2).
738468|NCT01259388||
738469|NCT01259375||
738470|NCT01259297||
738471|NCT01259284|Recruitment Period: January 06, 2011 to July 29, 2011. All recruitment done at UT MD Anderson Cancer Center.|The study was terminated with only 2 participants enrolled. The inability to find participants was predominantly due to current or recent use of statins or fish oils.
738472|NCT01259245|The recruitment and intervention part of the study took place between March 2011 and November 2011 with follow-up until May 2012. Subjects were recruited from four difference general out-patient clinics (GOPCs.|Using the inclusion and exclusion criteria, 192 adult subjects were enrolled into the study
738473|NCT01259128||
738474|NCT01259115|21-Oct-2002 (first subject, first visit) to 20-Jun-2003 (last subject, last visit). Study conducted at 1 site in New Orleans, LA.|Healthy male and female subjects aged 18 to 54 years, demonstrating successful inhibition of CYP3A4 using the EBT (erythromycin breath test) probe were randomized.
738475|NCT01259102|19-Nov-2000 (first patient, first visit) to 18-Mar-2001 (last patient, last visit) at 1 center in the US, Columbus, OH.|Subjects were assigned into 1 of 5 treatment groups with different recovery periods, ranging from 0 to 4 weeks. For the 5 treatment groups, the rest period was 0, 7, 14, 21, or 28 days, respectively, between the removal of the first buprenorphine transdermal system (BTDS) and placement of the second BTDS in exactly the same location.
738476|NCT01259089|The study opened for accrual on March 28, 2011 with an accrual goal of up to 30 patients in phase I and 25 patients in phase II. 18 patients were enrolled treated in phase I and 19 patients treated in phase II. The study was closed permanently on May 6, 2013.|
738477|NCT01259063||
738478|NCT01259024|Participant was screened and recruited on 1/5/2012|Single-arm study - participant received 1st trans-arterial chemoembolization treatment on 1/23/2012, second treatment on 2/20/2012, and third treatment on 3/20/12. Physician decision to withdraw participant on 4/12/2012 due to denial of CMS reimbursement.
738479|NCT01259011|"Patients were recruited between March 2010 and December 2012 from 20 outpatient dialysis centers in eight counties in North Carolina.
~A short battery of questions was used to help patients identify or confirm a previously designated surrogate. Patients and surrogates provided written consent."|
738480|NCT01258998|Recruitment Period: December 10, 2010 to February 20, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
738481|NCT01258985||
738482|NCT01258855||
738483|NCT01258803|Participants were recruited from 28 study sites in the United States. Primary Therapy Period: December 2010 to October 2011.|The study included a 4-week Run-In Period during which participants were treated with Mometasone Furoate (MF) Dry Powdered Inhaler (DPI) 100 mcg.
738484|NCT01258790||
738485|NCT01258738|This was a multicenter study conducted at 48 centers in 14 countries.|Eligible participants were randomized to receive etanercept or placebo for 12 week controlled (double-blind) period. Participants completing 12 week period entered a 92 week open-label period.
738486|NCT01258660|Healthy female volunteers aged 18 - 40 (inclusive), desiring contraception, with Red Blood Cell folate > 317 nmol/L and < 906 nmol/L, with no concomitant intake of vitamin supplements or medication containing folate or interacting with folate, and no vitamin B12 deficiency, were enrolled from 11 December 2006 to 15 January 2008 at 1 German center|235 female volunteers were screened according to the inclusion and exclusion criteria to determine that the volunteer was in a good state of health and appropriate for inclusion in the study, and 172 volunteers were randomized at one center.
738487|NCT01258608|This was a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of mapatumumab in combination with sorafenib in participants with advanced hepatocellular carcinoma.|A total of 217 participants were screened of which 116 were screen failures and 101 participants were randomized in a ratio of 1:1 to any one of the 2 treatment arms. The study was conducted at 29 centers in 6 countries.
738488|NCT01258595|Participants were enrolled from 15 November to 10 December 2010 in 4 clinical centers in the US.|A total of 300 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
738489|NCT01258582|The USHER-Phase II study was conducted in the emergency department at Brigham and Women's Hospital, Boston, MA. Between May 5, 2009 and January 4, 2010, USHER-Phase II consented eligible patients for the opportunity to be offered routine opt-in, rapid HIV screening. Enrolled subjects were randomized to fingerstick or oral specimen collection.|
738490|NCT01258504||
738491|NCT01258387|After informed consent, 40 patients with symptomatic Heart Failure (HF) were randomized (4:2) to GGF2 or placebo in 7 ascending dose cohorts. Patients were observed in hospital for 30 hours, then evaluated for adverse effects at 1, 2, 4, 12, and 24 weeks after infusion.|There were six patients in each cohort/dose level, four received active treatment (GGF2) and two received placebo. In each dose level, the first two patients were randomized 1:1 to GGF2 or placebo and monitored for safety prior to randomizing the remaining patients in the cohort 3:1. GGF2 or placebo was administered as an IV infusion.
738492|NCT01258374||The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. 15 patients were screenend and all of them were included and finish the study
738493|NCT01258348||The reasons for discontinuation listed in the Participant Flow are the reasons the participant discontinued treatment. All participants who received at least 1 dose of study drug were considered to have completed the study.
738494|NCT01258153||
738495|NCT01258101|A total of 395 participants were recruited at 20 centres in Austria in the study conducted from 20 May 2003 to 10 July 2008.|Of the 395 participants, 380 were randomized to treatment groups. A total of 15 participants were screening failures.
738496|NCT01258075|A total of 236 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to either Welchol 3.75 g (high-dose) or Welchol 0.625 g (low-dose).|Participants may have either been receiving metformin monotherapy or untreated with antidiabetic agents. All participants entered a 2-week, single-blind lead in/stabilization period after eligibility was confirmed. Metformin dose remained the same during the stabilization period.
738497|NCT01258049||
738498|NCT01257880|Over a 20-month period (January 2010 to May 2011), 127 subjects were screened and 31 were enrolled from Swedish Medical Center and the University of Washington Medical Center, including 19 with MA + PFO and 12 with MA - PFO.|"Of 127 potential subjects screened, reasons for exclusion included the following:
~22 (17%) chronic migraine or medication overuse headache; 9 (7%) topiramate use; 6 (5%) stroke or multiple sclerosis; 39 (31%) other (declined, low frequency); 12 (9%) small to medium sized PFO; 8 (6%) fetal origins."
738499|NCT01257802||2 of the 16 consented individuals were screen fails and therefore were not randomized.
738500|NCT01257750|Patients were recruited and consented at the Massachusetts Eye and Ear Infirmary Cornea Department from November 2010 - October 2011.|
738501|NCT01257737||
738502|NCT01257698||
738503|NCT01257581||
738504|NCT01257568|Recruitment in the Rejuvenate Modular Hip Stem study was terminated early. Participants can have one or both hips replaced. If both hips were enrolled in the study and only one hip completed the primary endpoint the participant is counted as completed.|42 participants/44 hips - 2 participants/2 hips censored = 40 participants/42 hips followed. There were 25 revisions, but one bilateral participant had one hip revised and the other hip completed the primary endpoint, this participant is counted as completed and not in the revision category.
738505|NCT01257542||
738506|NCT01257503||
738507|NCT01257438||
738508|NCT01257425|Patients diagnosed with advanced prostate cancer (locally advanced or metastatic, histologically proven) recruited at 23 investigational sites in Germany.|109 patients screened and 6 of these did not fulfil randomisation criteria therefore 103 patients were randomised to either group of treatment with triptorelin pamoate 3-month formulation applied intramuscularly or subcutaneously.
738509|NCT01257347|Primary care providers (the cluster units) and patients were recruited from 2010 to 2014 from 2 hospital-based primary care clinics in New York City.|200 patients were consented for the run-in and 100 were eligible for the trial and data analysis. 24 out of 49 primary care providers recruited had patients in the trial.
738510|NCT01257230||
738511|NCT01257217|Subjects were recruited from one investigative site located in Spain.|Of the 31 enrolled participants, 1 exited prior to randomization due to withdrawn consent and 5 discontinued after randomization due to adverse event (1) and protocol deviation (4). This reporting group includes all randomized participants who received IOLs without major deviations and/or surgical complications (efficacy population).
738512|NCT01257204||A total of 196 participants were enrolled, of which 152 participants were randomized; remaining 44 participants did not meet study criteria. Of randomized participants:151 were treated; 1 participant withdrew consent.
738513|NCT01257087||
738514|NCT01256983|49 patients were recruited|19 declined to participate after initial interest
738515|NCT01256944||
738516|NCT01256918|A consecutive sample of 200 eyes with cataract reporting to the eye outpatient department (OPD) of Dr. Ram Manohar Lohia (R.M.L.)Hospital and fulfilling the inclusion criteria, were enrolled in the study starting Nov.2010 till January 2011 ,after a written informed consent.|
738517|NCT01256879||
738518|NCT01256840|Calorie Restriction (CR) participants were recruited from the CR Society International, followers of the CR Way, and by referral from participants.|Inclusion criteria and indicators for CR were reporting calorie restriction without malnutrition for a minimum of two years, BMI < 24.99, and fasting glucose <80 mg/dL.
738519|NCT01256788||
738520|NCT01256684|A total of 464 subjects were screened at 33 medical/research sites located in the US (24 centers) and Canada (9 centers) and 255 subjects were randomized. The first subject first visit was on 30-NOV-2010 and the last subject last visit was on 29-JUL-2011.|
738521|NCT01256671|A total of 798 subjects were screened at 41 medical/research sites located in the US (31 centers) and Canada (10 centers) and 530 subjects were randomized. The first subject first visit was on 30-NOV-2010 and the last subject last visit was on 16-JUL-2012.|
738522|NCT01256658|This was an 18 clusters randomized study (1 cluster = 1 village). 14,075 participants were recruited during Period 1 (treatment); of these, 12,226 participants continued onto Period 2 (1 year follow-up) to assess longer term impact of initial intervention on malaria episodes. Period 2 was stopped and all participants discontinued.|During period 1 clusters were randomized 1:1 to either the control or the intervention arm (9 clusters per arm). In the intervention arm subjects were screened for asymptomatic carriage of P. falciparum status and treated with COA566. In both arms, subjects were treated for symptomatic malaria episodes. During period 2 there was no study treatment.
738523|NCT01256593||
738524|NCT01256567||
738525|NCT01256502||Enrollment was defined as having signed the IRB-approved Informed Consent Form. 160 patients were enrolled, of which 139 were implanted with SERI® Surgical Scaffold.
738526|NCT01256476||
738527|NCT01256450||Of 334 subjects who were enrolled in the open-label (OL) titration phase; a total of 235 completed the open-label titration phase and were randomized in the double-blind (DB) treatment phase.
738528|NCT01256424||
738692|NCT01248221|Subjects were recruited from public advertisement and the motility clinic at the Mayo Clinic in Rochester, Minnesota.|
738529|NCT01256411|Analyses on this open label extension study were performed according to treatment groups defined by the maximum and highest dose treatments received: 1) LCZ696 200 mg, 2) LCZ696 400 mg, 3) LCZ696 400 mg/Amlodipine, 4) LCZ696 400 mg/Amlodipine/HCTZ, 5) LCZ696 Mono (LCZ696 only), and 6) LCZ696 Combination LCZ696 with Amlodipine and/or HCTZ).|
738530|NCT01256398||
738531|NCT01256385||
738532|NCT01256294||
738533|NCT01256281||
738534|NCT01256190|Enrollment commenced in December 2010 and completed in October 2011 from 5 academic medical centers in the Netherlands|
738535|NCT01256177|A 56-days (8 week), multicenter, double-blind, randomized, parallel group, Phase III study was done to compare the efficacy and safety of quetiapine XR with placebo in the treatment of patients with bipolar depression. In total 296 patients were randomized in 19 centers in the China between December 2010 and November 2012.|361 patients were enrolled in the study of which 296 patients were randomized and 65 patients were not randomized. Reasons for patients not being randomized are (22 due to eligiblity criteria not fullfilled, 40 due to subject decision, 3 due to others).
738536|NCT01256164|Enrollment commenced in February 2011 and completed in October 2011 at 8 investigative study sites in the United States.|Approximately 90 eligible subjects were planned for enrollment, randomization, and treatment. The enrollment stopped short of the targeted 90 subjects due to enrollment of more subjects in the parallel study being conducted in the Netherlands.
738537|NCT01256086|First patient was enrolled in December 2010, last patient completed in July 2011|During screening phase (within 14 days before but at latest 2 days before randomisation), 2 methacholine tests on separate days (with and without pre-medication) were performed to check the suitability of the patients.
738538|NCT01256060|Participants were recruited from the hospital clinical database, as well as presentations at local conferences and media. Diagnosis was established using the Diagnostic and Statistical Manual, Fourth Edition for an Autism Spectrum Disorder supported by the Autism Diagnostic Observations Schedule and the Autism Diagnostic Interview - Revised.|Cohort 1 Dosage: 0.20 IU/kg - 3 participants Cohort 2 Dosage: 0.26 IU/kg - 3 participants Cohort 3 Dosage: 0.33 IU/kg - 3 participants Cohort 4 Dosage: 0.40 IU/kg - 6 participants
738539|NCT01256034||
738540|NCT01256008||
738541|NCT01255904||
738542|NCT01255865||
738543|NCT01255787|Participants took part in the study at 90 investigative sites in Japan, Europe and Asia/Oceania from 18 November 2010 to 25 April 2012.|Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, 5 mg, 10 mg, or 20 mg vortioxetine.
738544|NCT01255761|"Enrollment began in November 2010. Overall study completion occurred in December 2012.
~The Participant Flow consists of the Randomized Set (RS). The RS consists of all subjects randomized into the study.
~The Baseline Characteristics consists of the Safety Set (SS). SS consists of all subjects that received at least 1 dose of study medication."|"The Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.
~FAS-NRI: For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment were considered nonresponders at that visit. This is known as nonresponse imputation (NRI)."
738545|NCT01255722|A total of 468 patients from 5 European countries were enrolled and evaluated between 3 November 2010 and 17 September 2012.|
738546|NCT01255631||
738547|NCT01255592|This multicenter study was conducted in Europe between 27 December 2010 and 13 February 2012.|
738548|NCT01255449|The recruitment started on 10-Nov-2010 and finished on 15-feb-2012. The recruitment was performed at Pulmonary Function Tests Laboratory of IRCCS AOU San Martino.|All patients were in stable clinical conditions and none had a history of significant respiratory disease.
738549|NCT01255436|Patients with hypertension, maintained on blood pressure-lowering medications, who fulfilled the inclusion/exclusion criteria, and consulting at the General Medicine outpatient continuity clinic were recruited over a period of 6 months.|
738550|NCT01255423|Study Start 30 Nov 2010 Study end 17 Juin 2011|
738551|NCT01255306|"Patients with a diagnosis of retinal detachment who fulfilled enrolment criteria were included in the study. All patient were enrolled through University Department of Ophthalmology, University Hospital Sestre milosrdnice.
~The recruitment started in April 2010 and the last patient was enrolled in June 2011."|We excluded one patient who developed severe inflammatory reaction 5 days following pars plana vitrectomy and silicone oile tamponade from the study.
738552|NCT01255163|Recruitment took place between 10/5/2010 and 7/25/2016. A total of 57 participants signed informed consent to undergo screening procedures. Of those, 28 qualified, 1 withdrew prior to randomization, 27 were randomized to exenatide or placebo, and 18 completed the study.|The study includes a baseline visit to determine eligibility. Therefore, 57 participants were enrolled (i.e. signed informed consent prior to screening). Of those, 28 qualified, 1 withdrew prior to randomization, 27 were randomized to exenatide or placebo, and 18 completed the study.
738553|NCT01255137||
738554|NCT01254890|Recruitment Period: January 11, 2011 to February 4, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
738555|NCT01254877||357 persons signed informed consent; 205 were randomized. 137 exclusions were mainly due to insufficient alcohol use (as determined by self-report or biomarker), abnormal QT interval, or significant mental health symptoms that precluded assessment completion. An additional 13 participants withdrew, were discontinued by the investigators or died.
738556|NCT01254851|This randomized controlled trial enrolled patients who were going to undergo gynecologic surgery were enrolled from 1/11-6/11 at Loyola University Medical Center .We approached adult (>18 years) English speaking women prior to undergoing major gynecologic surgery who were expected to have at least a 24-hour hospital stay post-operatively.|All Enrolled patients were randomized to a group. Those patients who were enrolled but not included in statistical analysis had their data lost due to lost pedometer.
738557|NCT01254760|A total of 79 participants were recruited at 7 US sites from December 3, 2010, to January 20, 2011.|Seven participants were enrolled in the study but not dispensed due to failed inclusion/exclusion criteria (2); unsatisfactory vision (2); unacceptable comfort (1); and subject withdrawal (2). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
738623|NCT01251965|Recruitment Period: December 9, 2010 to September 26, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
738558|NCT01254747|Participants were recruited and enrolled from 1 US study center and 1 German study center.|This reporting group includes all enrolled and dispensed participants (129). One US participant was enrolled, but not dispensed.
738559|NCT01254721||
738560|NCT01254669|We recruited 100 English- and 100 Haitian Creole-speaking mothers of adolescent girls between April 2011 and September 2013 at the medical clinic ( pediatrics and adolescent clinic). Of 1,703 mothers approached during the study period,1,201 were ineligible. Of the 502 eligible, 302 declined and 200 (40%) were recruited &consented to pilot trial.|Following participant enrollment, but prior to group assignment, no significant event occurred. However, in our study after being randomized, participants provided demographic data. During data collection, one participants was excluded/self-withdrew from the trial for fear that demographic data may affect her immigration status/not documented.
738561|NCT01254656|Participants who had completed 96 weeks of treatment with lersivirine in the A5271015 parent study were enrolled in this extension study. One participant from a second parent study (A5271022) was initially enrolled in Study A5271037, but later discontinued from A5271037.|Participants were required to have plasma HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 84 of the parent protocol. Of 108 participants screened in the parent protocol A5271015, 47, 43, and 18 participants from the lersivirine 500 mg, lersivirine 750 mg, and efavirenz 600 mg groups, respectively, were enrolled in Study A5271037.
738562|NCT01254643||
738563|NCT01254630|Adult participants with a diagnosis of solid tumor malignancy (STM) or hematologic malignancy (HM) were enrolled from 328 sites.|Out of 5507 screened participants, 5305 were randomized. Twenty randomized participants were not included in analyses: 19 participants from a single site identified to have major Good Clinical Practice compliance issues and 1 participant that was not vaccinated. Thus, a total of 5285 were included in analyses.
738564|NCT01254604||
738565|NCT01254565|This study was conducted at 11 study centers in the United States from 17 February 2011 (first participant enrolled) to 24 August 2011 (last participant completed follow up). A total of 87 patients with secondary hyperparathyroidism (HPT) receiving hemodialysis were enrolled and randomized in the study.|This was a multiple-ascending dose study consisting of 3 cohorts: Cohort 1 participants were randomized in a 3:2 ratio to receive etelcalcetide or placebo for 2 weeks; Cohorts 2 and 3 were randomized in a 1:1 ratio to receive etelcalcetide or placebo for 4 weeks. Randomization was stratified by serum parathyroid hormone (< 600 or ≥ 600 pg/mL).
738566|NCT01254552||
738567|NCT01254422|Study participants were enrolled from 02 December 2010 to 10 February 2011 at 4 clinical sites in Malaysia.|A total of 250 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
738568|NCT01254409||
738569|NCT01254396||
738570|NCT01254344||
738571|NCT01254331||
738572|NCT01254318|Participants with hematologic malignancy requiring high dose chemotherapy with or without stem cell transplant were selected from a single tertiary care center in Canada.|
738573|NCT01254305|Patients were recruited over a 12-month period from April of 2011 to April of 2012 at 20 studies sites in the United States.|Patients went through a 1-week single-blind placebo run-in period, followed by an 8-week double-blind treatment period.
738574|NCT01254292|The study was conducted in 42 centers across 4 countries in Austria, Belgium, Germany and United States.|644 subjects were screened, of which 77 were screen failures and 567 were randomized, 282 subjects to LCS12 and 285 subjects to Yasmin. 279 subjects randomized to LCS12 while 281 subjects randomized to Yasmin received treatment and started comparative phase up to 18 months. 200 subjects randomized to LCS12 entered extension phase up to 36 months.
738575|NCT01254214||66 people were screened, 3 were ineligible, and of the 63 who consented only 55 actually participated in the trial.
738576|NCT01254188||
738577|NCT01254045||Ten enrolled. One on antipsychotic mediation at baseline excluded, and one lost to follow-up after baseline. Eight participants included in data analysis. Each participant received a dose of either oxytocin(OT) 24 international units (IU)/intranasal placebo 24IU, OT 48IU, or placebo 48IU at each of 3 weekly visits.
738578|NCT01254019|This study was conducted across 44 centers in 19 countries from 02 December 2010 to 28 June 2013.|A total of 186 participants were randomized which included males with a maximum age of 16 years, no adults were included in this study.
738579|NCT01253980|Recruitment period: 21 July 2010 - 21 September 2011 (24 hours a day) Patients recruited from Medical Emergency Department|
738580|NCT01253902||
738581|NCT01253824|"Fifty one subjects were screened for this study after acquiring an informed consent.
~18 subjects of those participated in pre-medication menstrual cycle phase to confirm baseline of estradiol, progesterone, FSH and LH.
~4 subjects withdrew IC during this phase, therefore, 14 subjects were registered and allocated study drugs."|
738582|NCT01253811|The trial was conducted at 5 sites in 3 countries as follows: Israel (IS): 1 site; United Kingdom (UK): 2 sites; and United States (US): 2 sites.|Subjects who completed the F13CD-3760 (NCT01230021) trial were eligible to get enrolled in this trial.
738583|NCT01253642||
738584|NCT01253577|Patients were recruited in the United States between December 2009 and July 2010 from eleven otolaryngology-head and neck surgery centers by 31 surgeons representing both academic and private practices.|Sinus randomization was performed at the end of successful endoscopic sinus surgery.
738585|NCT01253564||
738586|NCT01253525||Participants were considered completed if they either completed Cycle 1 of study drug or discontinued study drug due to a dose limiting toxicity (DLT) during Cycle 1.
738587|NCT01253460|Recruitment Period: 8/22/2011 to 12/19/2013|
738588|NCT01253447|Recruitment Period: October 27, 2010 to October 30, 2012. All recruitment done in medical clinics, either UT MD Anderson Cancer Center or Fred Hutchinson Cancer Research Center.|
738589|NCT01253421|Participants were recruited at McLean Hospital (Belmont, MA) and Massachusetts General Hospital (MGH; Boston, MA) between February, 2012, and September, 2015. The study was advertised using flyers, and on a number of internet bulletin boards available to the general public. Study visits were conducted in research facilities at McLean Hospital.|An assessment visit was conducted prior to the drug-challenge visit. Subjects had a diagnostic interview (SCID) and preliminary physical exam, provided a blood sample for lab tests, and completed surveys, to determine eligibility. Those meeting eligibility criteria were scheduled for a drug+scanning visit where randomization occurred.
738590|NCT01253408|All participants were recruited from a database of patients with irritable bowel syndrome (IBS) who reside within 150 miles of Rochester, Minnesota from October 2008 through April 2011.|
738591|NCT01253369|Patients enrolled from November 2010 through April 2012.|
738592|NCT01253343|Between May 2011 and November 2011, we recruited 17 psychiatrically hospitalized boys (ages 7 to 9 years). We categorized the 17 participants into 2 groups, high aggression risk and low aggression risk, based on their initial BRACHA score.|Inclusion criteria included boys aged 7 to 9 years, with BRACHA scores, admitted to a psychiatric inpatient unit. Exclusion criteria included presence of infection requiring antibiotics within 2 weeks, recent surgery within 8 weeks, bleeding gums within 8 weeks of admission, current detainment in juvenile detention, and steroid use.
738593|NCT01253317||
738594|NCT01253304||
738595|NCT01253291||Participants who completed NCT01253226 [Study H9B-JE-BCDK (BCDK)] were enrolled into open-label study NCT01253291 [H9B-JE-BCDL (BCDL]).
738596|NCT01253265||
738597|NCT01253226||This dose-escalation study had 4 cohorts. Each cohort included 6 LY2127399 (tabalumab) participants and 2 placebo participants. Participants treated once every 2 weeks (Q2W) or once every 4 weeks (Q4W) and had a follow-up visit at Week 32. Additional visits beyond Week 32 were scheduled, as needed, for B cell count monitoring (up to 12 weeks).
738598|NCT01253200|Subjects were recruited from referring physicians for ablation for type 1 atrial flutter|Subjects were excluded if there were no documented episodes of atrial flutter or inclusion criteria were not met. Roll-in subjects were not randomized.
738599|NCT01253187|Healthy young women, aged 18 - 38 years inclusive, who were nonsmokers were enrolled from 20 October 2006 to 13 September 2007 at one center in Germany.|77 female volunteers were screened according to the inclusion and exclusion criteria to determine that the volunteer was in a good state of health and appropriate for inclusion in the study, and 44 volunteers were randomized at one center.
738600|NCT01253174|Healthy young women, aged 18 - 38 years inclusive, who were nonsmokers were enrolled from 16 August 2006 to 4 July 2007 at one center in Germany.|147 female volunteers were screened according to the inclusion and exclusion criteria to determine that the volunteer was in a good state of health and appropriate for inclusion in the study, and 48 volunteers were randomized at one center.
738601|NCT01253148|Twenty-five participants were enrolled at Moffitt Cancer Center between 2010 and 2013.|
738602|NCT01253135|Subjects were enrolled at a single US investigation site, between February 2, 2011 and July 5, 2011.|Subjects who met all inclusion/exclusion criteria received paired superficial thermal injuries, one on the ventral aspect of each forearm, using liquid nitrogen. The test article applied to each arm was determined by randomization code. Wound status (closed/open) was assessed by a blinded assessor.
738603|NCT01253070|A total of 54 participants were recruited from April 2011 to August 2013.|
738604|NCT01253044||
738605|NCT01253018|Recruitment occurred between April 2011 and March 2014. The study location was a clinical research setting within the Veterans Affairs Maryland Health Care System.|14 enrolled participants were withdrawn prior to randomization due to not meeting FM inclusion criteria, or due to medical or social issues.
738606|NCT01252966|Recruitment for this clinical trial began in March 2011. Study accrual was completed in September 2015, with a final sample of N=213 in the intention-to-treat (ITT) analysis.|Five hundred and fifty-seven participants provided consent and 213 were randomized. Reasons for exclusion from randomization included no home computer or internet access and failure to meet final eligibility criteria at the Intake Visit.
738607|NCT01252953|Participants were randomized between August 2011 and October 2013. Follow-up continued until 31st January 2017.|Successfully screened participants were entered into a run-in period. Attendees were discouraged from continuing to randomization if it was thought unlikely they would be able to continue attending follow-up visits for at least 4-5years. During run-in participants were issued atorvastatin (1 tablet/day) and placebo anacetrapib (1 tablet/day).
738608|NCT01252940|Participants were enrolled at 110 sites in the North America and Europe. The first participant was screened on 17 November 2010. The last participant observation was on 28 October 2014.|617 participants were screened.
738609|NCT01252810||
738610|NCT01252745||
738611|NCT01252667||
738612|NCT01252563||A total of 14141 participants were registered in the study. Of the 14141 participants, 366 participants were excluded from the study because their case report forms were not collected, mainly due to the lack of cooperation from the investigators. Finally, 13775 participants were included in the study.
738613|NCT01252355|"The recruitment initiated in January 2011, was discontinued in December 2012 following the decision of the Sponsor to discontinue the study, the common treatment end date was defined as February 28th, 2013 (treatment duration between 24 and 108 weeks).
~A total of 846 participants were screened at 185 sites in 28 countries."|Randomization was stratified by investigational site and Interferon-beta (IFN-beta) dose level (high/low). Assignment to groups was done centrally using an Interactive Voice Response System (IVRS) in a 1:1:1 ratio after confirmation of selection criteria. A total of 534 participants were randomized.
738614|NCT01252290||
738615|NCT01252277|"Women at high risk for development of breast cancer, seen in the Breast Cancer Prevention Center at the University of Kansas Medical Center.
~Recruitment December 2010 to August 2012"|
738616|NCT01252251|Protocol Open to Accrual 11/30/2010, Protocol Closed to Accrual 8/11/2015, Primary Completion Date 6/13/2016, Recruitment location is the medical clinic|
738617|NCT01252238|Recruitment occurred from 8/2009 thru 12/2011 at Brigham and Women's Hospital, Boston, MA.|All subjects washed out blood pressure medication for two weeks and ran in for two weeks on amlodipine 2.5-10mg titrated to BP <160/90 every other day. All subjects consumed a very low salt calculated diet for one week followed by calculated high salt diet for 2 weeks prior to randomization
738618|NCT01252186||
738619|NCT01252147||
738620|NCT01252134|Participants were recruited and enrolled from one Canadian study center.|
738621|NCT01252095|Patients were recruited from Perth oncology clinics and treated under the PG545101 protocol at the dedicated phase I unit, Linear Clinical Research Ltd. The recruitment period was November 2010 to October 2011.|
738622|NCT01251978||10 participants were enrolled - 2 participants were eliminated early in the study for non compliance.
738624|NCT01251952|Cancer center clinic.|
738693|NCT01248130||
738628|NCT01251744||Out of 82 pregnant subjects enrolled, 77 started this study: 4 were excluded from stat analyses; 1 had no available cytomegalovirus (CMV) infection status (IS) of her offsprings. Out of 82 offsprings, 78 newborns were enrolled (mothers signed informed consent) and 4 foetuses (stillbirth/termination) had CMV IS available but were not enrolled.
738629|NCT01251653|All patients were completed the study but discontinued from the trial medication|This was an uncontrolled, open-label, Phase I, '3+3' dose-escalation trial to determine the maximum tolerated dose (MTDs) for combination Afatinib with Gemcitabine or with Docetaxel; 2 MTDs were to be defined, one for Afatinib with Gemcitabine (Cohort A) and one for Afatinib with Docetaxel (Cohort B).
738630|NCT01251614|Participants were enrolled at 38 sites in Belgium, Canada, Chile, Czech Republic, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Spain, Switzerland, and Turkey.|Participants were randomized to receive adalimumab 0.8 mg/kg, adalimumab 0.4 mg/kg, or methotrexate (MTX) in a 1:1:1 ratio and were stratified according to prior history of etanercept treatment.
738631|NCT01251588||
738632|NCT01251575||
738633|NCT01251536||
738634|NCT01251393||55 participants in the placebo group and 56 participants in the biperiden group.
738635|NCT01251380|This was a multicentre study performed at 27 investigational sites in France, Mexico, Turkey, Poland, Chile and the United States of America (USA). Twenty six sites recruited at least one subject and the other site was inactive.|Of 216 subjects enrolled in this open label study from Study Y-55-52120-141, 203 went straight into Cycle 1. 13 subjects were not considered eligible for re-treatment at end (all of whom had received Dysport) and as per study design they entered into the observational phase of Study 147. Of these 13, 4 subjects entered Cycle 1 at a later date.
738636|NCT01251367|The study was designed as a multicentre study and included 51 sites in Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia and the United States of America that included at least one subject. The current study (Study 142) was an open label extension to the double blind Study 140 (Y-55-52120-140).|A total of 366 subjects completed Study 140, of which 352 subjects were enrolled in Study 142. Of these, 7 subjects entered an observational phase and never received open label treatment with Dysport® in Study 142 and the remaining 345 subjects started treatment and received at least one open label injection of Dysport® in Study 142.
738637|NCT01251354|Participants were recruited from United States of America and Canada from 08-Feb-2011. Terminated on 06-Jun-2011 and Study Completion was on 26-Jul-2011.|Six patients from five centres were screened for inclusion. All six patients were enrolled and treated
738638|NCT01251315|The participants were recruited between may 2010 through June 2010. Healthy volunteers were recruited by physician referrals from community clinics.|No enrolled participants were excluded.
738639|NCT01251276|A total of 296 participants were eligible for the challenge-dose study and 204 were enrolled|Study participants received 3 doses of Modified Process Hepatitis B Vaccine or ENGERIX-B™ vaccine in the Base Study (V232-059, NCT00440531). Two years after completion of the Base Study vaccinations, participants were eligible to receive one challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study.
738640|NCT01251146||
738641|NCT01251120||
738642|NCT01251042||51 subjects were enrolled but 2 subjects were never randomized and have thus not been included in the analysis.
738643|NCT01250990||
738644|NCT01250977|Thirty subjects were consented and screened for eligibility at an Intake Visit at the Center for Interdisciplinary Research on Nicotine Addiction (Philadelphia, PA).|Twenty subjects ultimately completed a Baseline Visit and were randomized to receive Donepezil or Placebo.
738645|NCT01250925|94 Neophyte contact lens wearers were fitted for one of 3 types of contact lenses (Bausch and Lomb PureVision; Vistakon Acuvue Oasys or Cooper Vision Biofinity) and were then randomized into one of three test articles (care regimens): OptiFree RepleniSH Multi-Purpose Disinfecting Solution, Clear Care or ReNu MultiPlus Multi-Purpose Solution.|127 subjects were screened, out of which 94 were successfully enrolled and 35 were screenfailed due to non-normal clinical findings. Of the enrolled, 10 did not complete the study visits.
738646|NCT01250899||
738647|NCT01250873||
738648|NCT01250834||
738649|NCT01250769||
738650|NCT01250756||
738651|NCT01250730||"Twelve healthy subjects were assigned to open-label crizotinib treatment in either the 150 mg cohort (6 subjects) or 250 mg cohort (6 subjects).
~After the completion of assessment of safety at both 150 mg and 250 mg cohorts, the 400 mg cohort, the highest dose level in this study, was started."
738652|NCT01250717|Between September 28, 1999 and May 17, 2005, 28 participants with high risk localized prostate cancer were enrolled on this IRB approved phase II protocol from BIDMC Urology clinics|This was a single arm study and there were no arms. Participants were screened for final eligibility after consent was completed. All enrolled subjects were treated
738653|NCT01250509|Female participants were recruited through media outlets and flyers posted in the San Francisco Bay Area. Three hundred twenty-two potential participants were screened for eligibility from November 2006 to March 2007.|Fifty-three met eligibility criteria and chose to enroll, and 47 went on to the randomization stage. Before randomization, 5 participants dropped due to time constaints and 1 dropped due to illness.
738654|NCT01250418||
738655|NCT01250379|A total of 556 participants were screened and of these, 494 were randomized.|
738656|NCT01250210|Planned enrollment included: approximately 30 subjects in the AG200LE treatment group, 30 subjects in the AG200 treatment group and 20 to 30 subjects in the AG200 15 treatment group. Actual enrollment included: 45 subjects in the AG200 treatment group; 45 subjects in the AG200LE treatment group; and 33 subjects in the AG200-15 treatment group.|: Subjects enrolled were healthy adult women aged 18-45 years with a history of regular menstrual cycles (i.e., lasting between 21 and 35 days) and no disorders precluding hormonal contraceptive use.
738657|NCT01250184|In the databases of two general and specialized medical institutions, 762 patients were identified to have non-specific myalgia or muscle disorders diagnoses. A nurse by phone and two medical physiatrists at the hospitals, with over 10 years of research experience evaluated the MPS patients and their medical history.|The randomization process was performed using permuted blocks.This process was performed by an investigator (HIG) who had no contact with the patients. The allocations to each treatment were placed in consecutive sealed, opaque envelopes, were kept in the research headquarters and were taken to the site according to the number of patients referred.
738658|NCT01250171||One patient randomized to the secukinumab group did not receive study drug and was not included in any of the analysis sets.
738659|NCT01250145||
738660|NCT01250119||
738661|NCT01250054||This reporting group includes all enrolled and dispensed participants.
738662|NCT01250002|Subjects were recruited in the preoperative area of the hospital between November 2010 and September 2011.|All participants were assigned to groups.
738663|NCT01249872|Between January 2010 and September 2012, a total of 107 morbidly obese patients undergoing an open weight loss surgery (BPD-RYGBP) were assessed for eligibility, with 96 patients randomized to one of the six Groups (n=16)|"From the 107 patients, assessed for eligibility, 11 patients were excluded due to:
~Surgery postponed (n=3)
~Decline to participate (n=2)
~Prolonged surgery >4h, due to complications (n=3)
~Failure to place epidural catheter (n=3)"
738664|NCT01249833||
738665|NCT01249664|The study was conducted at 20 study centers in 5 countries. Recruitment period: 17 Dec 2010 - 28 Feb 2013.|A total of 173 participants were screened.
738666|NCT01249651|First participant enrolled on 23 November 2010. Last participant completed on 11 June 2011. Out of 101 enrolled participants, 100 participants (target was 100) received esomeprazole 40 mg. All of the participants were included in safety analysis set and 96 out of the 100 participants were included in the full analysis set for efficacy analyses.|Participants with a history of reflux oesophagitis and with continuing heartburn after previous treatment with rabeprazole 20 mg were included in this study.
738667|NCT01249625|participants were recruited from outpatient settings considered at high risk for respiratory illnesses (emergency rooms, internal medicine and pediatric clinics) and had to work at least 24 hours per week in a given setting. They had to have face to face exposure to patients and be willing and able to participate, sign informed consent.|
738668|NCT01249417|Each centre that participated in the study was expected to randomise between five and 25 subjects. It was planned to have at least two participating centres per country.|"Screening details:
~A total of 241 subjects were randomised to the study. The safety population included 239 subjects who were treated. Out of the 239 treated subjects, 4 subjects were excluded from the Intent-to-Treat (ITT) population because no MAS score was obtained at the baseline visit and/or at Week 4."
738669|NCT01249404|The study was designed as a mutlicentre study and included 62 investigational centres in Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia and the United States. Subjects were screened at 53 centres and in 52 centres subjects were randomised to receive study treatment.|A total of 456 subjects were screened, 388 were enrolled into the study and randomised to 1 of 3 treatment groups.
738670|NCT01249365||
738671|NCT01249274|On-site clinic screening assessments were performed in three obstetrics clinic associated with the Yale New Haven Hospital System in New Haven, CT, USA. Study referrals were accepted from the New Haven area. Both post-partum and pregnant women were screened. Screenings began in October of 2010 and finished in February of 2013.|75 women were scheduled for intake, but 24 did not complete intake interview and 1 was ineligible for randomisation because of a medical issue. The first 50 eligible women were randomly assigned.
738672|NCT01249261|Screening began 4 October 2001|Patients who sequentially completed Clinical Studies RVE009093 (3 year core study), RVE1996077 Year 4/5 extension study) and RVE1998080 (Year 6/7 extension study) were eligible for screening. [No NCT numbers available]
738673|NCT01249157||
738674|NCT01249131||
738675|NCT01249118||The study was divided into two parts. In part 1 of the study, safety of GDC-0973 was evaluated and in part 2 pharmacokinetics (PK) of GDC-0973 was evaluated. All PK outcomes apply only to part 2 of the study while safety applies to part 1 and 2 both.
738676|NCT01249092|Patient enrollment was initiated in December 2010 and a total of 20 patients were enrolled. The last patient to complete the pilot study completed participation in June 2012.|This was a single arm open label pilot study where all subjects received the same intervention throughout the study duration. There were no different study groups and no randomization was involved.
738677|NCT01249027|XIENCE V China SAS was designed to enroll approximately 2500 patients. The first patient was enrolled on November 26, 2010. The enrollment was completed on December 10, 2011, with a total of 2605 patients enrolled at 53 sites. Of 2605 patients, a total of 123 subjects were withdrawn. Per protocol population is 2482.|A total of 123 subjects were withdrawn due to following reasons: 82 subjects had incomplete informed consent procedures;11 subjects enrolled repeatedly;1 subject did not have a stent at the starting point for surgery;18 subjects surgically implanted with other stents at the start;1 subject withdrew informed consent;10 subjects deregistered.
738678|NCT01248962||
738679|NCT01248949||A total of 162 participants were screened, of which 46 did not meet eligibility criteria and were considered as screen failures; the remaining 116 participants entered into the study and treated with MEDI3617.
738680|NCT01248936|The study was conducted in 29 study sites in the United States (US). The study period was from 10 December 2010 to 24 October 2011.|Overall, 745 participants were screened during the study, of which 374 were enrolled to receive study treatment; the main reason for screen failure was negative cobas test, consent withdrawal, BRAF test not performed, patient died or progressed, and other unspecified reasons. Of 374 participants, 3 did not receive treatment after enrollment.
738681|NCT01248884|A total of 721 subjects were enrolled in the study.|
738682|NCT01248793||
738683|NCT01248780||In this trial, 264 participants were randomly assigned to the 2 treatment arms.
738684|NCT01248741|20 patients were recruited from the target population of men with localized prostate cancer undergoing radical radiotherapy consisting of a combination of external beam radiation and 2 fractions of 10 Gray each of High Dose Rate brachytherapy|
738685|NCT01248728|Participants were recruited from the hospital clinical database, as well as presentations at local conferences and media. Diagnosis was established using the Diagnostic and Statistical Manual, Fourth Edition for an Autism Spectrum Disorder supported by the Autism Diagnostic Observations Schedule and the Autism Diagnostic Interview - Revised.|Participants were randomized to the two arms in a 1:1 fashion by the pharmacy, based on a randomization schedule produced by the study biostatistician. They were stratified into one of four strata based on the PDDBI score obtained at screening (four quartiles).
738686|NCT01248715||
738687|NCT01248585||
738688|NCT01248468||
738689|NCT01248455||
738690|NCT01248416||
738694|NCT01248104|Adult patients scheduled for primary cardiac surgery utilizing CPB at LLUMC . Subjects myst be >30 kg, be able to understand English, and sign the consent form.Subjects will be recruited in the pre-admitting area prior to going to the PDCU area in the operating room.|
738695|NCT01248065||
738696|NCT01248013|Patients were recruited at their initial visit to an IBS treatment center, on a purely voluntary basis into a group hypnotherapy program, from 2005 to 2009. 75 patients were entered into the study. Another 14 filled out initial questionnaires but then declined to enter treatment or dropped out after 1 or 2 sessions.|There was no control group assignment in this preliminary study which was designed to see if hypnotherapy, already proven effective in individual treatment was effective when using a group format.
738697|NCT01247974||One subject, Subject 011-006, was randomized in error to the ECM treatment group, but did not provide informed consent. This deviation was discovered prior to the surgery.
738698|NCT01247922|Participants recruited for this OSI-774-206 study were participants with pediatric ependymoma previously treated with oral etoposide in Study OSI-774-205 who progressed while on study or discontinued due to unacceptable toxicity.|Participants who consented to enter this OSI-774-206 study and fulfilled all the eligibility criteria (no more than 14 days prior to registration) were enrolled in this study no more than 21 days from the last dose of oral etoposide in Study OSI-774-205.
738699|NCT01247675||
738700|NCT01247571||
738701|NCT01247428||
738702|NCT01247363||
738703|NCT01247350||
738704|NCT01247324||A total of 1051 participants were screened for entry into the study. 821 participants were entered into the double-blind treatment period. Participants who completed the 96-week double-blind treatment had an option to enter a single group, active treatment open label extension, providing they fulfilled the eligibility criteria.
738705|NCT01247298||
738706|NCT01247285||
738707|NCT01247272||
738708|NCT01247220||
738709|NCT01247090||
738710|NCT01247064||
738711|NCT01246999|In the first year participants were randomly assigned to receive LAIV twice, TIV twice, LAIV followed by TIV or TIV followed by LAIV. In the second year, randomization was confined to 2 groups: LAIV twice or TIV followed by LAIV. 8/34 participants were in the two arms not included in the analysis.|
738712|NCT01246986||Participants who had progressive disease or death are defined as completed. Per the protocol, following an interim analysis, the decision was taken to no longer randomize participants to the 160 mg LY2157299 arm.
738713|NCT01246973||
738714|NCT01246960||
738715|NCT01246895|All eligible subjects who were treated under Protocol CG-CIP01-P and completed the required 12-month follow-up period were asked to participate in this follow-up study. Ultimately, 67 subjects signed an ICF to enter the study and the screening process.|
738716|NCT01246791|Thirty healthy female are screened for this study. Appropriate subjects who satisfy inclusion criteria were enrolled for this study.|
738717|NCT01246713||Whether subjects received the solid or liquid preparation initially was randomly chosen.
738718|NCT01246479||
738719|NCT01246401|151 subjects consented, 58 lost before randomization|
738720|NCT01246349|Overweight and obese youth (BMI ≥ 85th %ile for age and gender) were eligible to participate and were recruited directly by the primary investigators from the Toronto East General Hospital's Healthy Lifestyles program, comprised of children and adolescents ages 10-18 years who are seeking diet and exercise treatment for their obesity.|Individuals were excluded if they: 1) were taking medication whose side effects may influence weight gain or weight loss, 2) did not speak English, 3) had a known developmental delay, and 4) reported being pregnant and/or having an active eating disorder.
738721|NCT01246258||
738722|NCT01246206||
738723|NCT01246076|The study opened to participant enrollment on 06/30/2011 and closed to participant enrollment on 05/19/2014.|
738724|NCT01246063|The study opened to participant enrollment on 05/14/2012 and closed to participant enrollment on 08/02/2016.|
738725|NCT01246050|Primary care providers practicing were recruited from Primary Care Clinics in the local VA healthcare system. Providers volunteered to be trained as Heart Failure providers and underwent specialized training in May 2010.|
738726|NCT01246011|The study began enrolling in January 2011 and screening ended in July 2011, after it was decided that enrollment was too slow and that the study should be terminated.|
738727|NCT01245972||
738728|NCT01245764||
738729|NCT01245751||
738730|NCT01245738|Data were collected at the time of the first acute coronary event and 12 weeks after post-event statin therapy among participants across 19 tertiary cardiac care centers in India.|635 participants were considered eligible for the study, however; only 514 started (had complete baseline data).
738731|NCT01245699||
738732|NCT01245673||
738733|NCT01245647|We recruited participants from 3 sites in 3 cities: Washington, D.C., Chicago, and Jacksonville from December 2010 to February 2012. The last participant completed her 7-Month follow-up at October 2012.|
738734|NCT01245595||
738735|NCT01245439||
738736|NCT01245413|"20 healthy volunteers and 12 colostomists were recruited to the study. The colostomist were recruited from a user data base in Denmark. The healthy volunteers were recruited by advertising in local news papers, on www.forsøgsperson.dk and by poster atSkodsborg hotel og spa (a fitness centre)"|32 subjects were enrolled and randomised in the study.
738737|NCT01245387||This observational study did not define endpoints as primary or secondary. All endpoints arbitrarily assigned as primary for reporting results.
738738|NCT01245374|The trial was conducted in France (38 sites). Recruitment period occurred from 17-Nov-2010 to 18-Apr-2011.|Eligible participants had to receive training for the use of Nordiflex® system. A member of the investigator's team, physician or nurse, was in charge of this training. At inclusion and before receiving treatment, participants or parents had to complete a questionnaire about the ease of use of the previously used device.
738739|NCT01245283||
738740|NCT01245270|Eight male volunteer subjects with T2D controlled by diet and lifestyle alone or with impaired glucose tolerance were recruited from the Aberdeen area of the UK. Subjects were only included if they were not on any special religious or prescribed diet and had a stable weight.|
738741|NCT01245140|The study was conducted at 7 centers from 26 April 2011 to 16 April 2014, in male and female participants of Palmo-plantar pustulosis (PPP), aged >= 18 years.|The total study duration was 33 weeks, with a Screening Period of up to 4 weeks, followed by 24 weeks of treatment and a 5-week safety Follow-up Period. Participants who met eligibility criteria were randomized (2:1) to receive 30 milligrams (mg) alitretinoin or matching placebo, given orally as gelatin capsules, once daily (QD) for up to 24 weeks.
738742|NCT01245101|Please note: because of poor enrollment and inability to find the originally planned 40 patients, the study was terminated after only 15 of 20 planned patients had been enrolled into the Raltegravir Then Observation arm. No patients were enrolled into the Observation Then Raltegravir arm.|
738743|NCT01245062|This was a randomized open-label, multi-center Phase III study to evaluate the efficacy and safety of single agent trametinib compared with chemotherapy (CT) (dacarbazine or paclitaxel). Participants (par.) were enrolled by 86 sites in 19 countries from December 2010 to July 2011. Results as of 16 December 2016 data-cut have been presented.|Participants (par.) were stratified for lactate dehydrogenase and prior CT for advanced or metastatic disease. 1059 par. were screened and 322 were enrolled to receive trametinib (214 par.) or CT (108 par.) until disease progression, death, or withdrawal. Par. randomized to CT were allowed to cross-over to trametinib if disease progressed.
738744|NCT01245049|2 subjects did not receive vaccination.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
738745|NCT01244984||Following screening (Visit1) and a 2-week Run-in Period during which participants continued to use their respective asthma therapy at a fixed dose. Participants who met continuation criteria at the end of Run-in Period (Visit 2) were allocated to a 52-Week Treatment Period.
738746|NCT01244906||
738747|NCT01244893|4 investigation sites were used within the U.S. for this study, with a study duration of Oct 23, 2010 to Nov 7, 2010.|44 subjects enrolled; 42 completed as cohort, two subjects were discontinued.
738748|NCT01244828||
738749|NCT01244815||
738750|NCT01244724||Of the 26 subjects enrolled only 17 actually returned and began medication.
738751|NCT01244711||
738752|NCT01244633||
738753|NCT01244620|The study was terminated for safety reasons (hepatoxicity) after dosing was completed for the first intervention.|
738754|NCT01244529||
738755|NCT01244516|There were thirty-five sites recruited in the US. There were 540 subjects recruited with 520 enrolled and randomized. The study was a 2-week, randomized, single-masked (subjects), parallel arm, bilateral dispensing study. The subject group was expected to be representative of a cross-section of the population within the US contact lens market.|There were 20 subjects who did not meet the inclusion or did meet the exclusion criteria. There were 10 screen failures and 10 who wore spectacles to baseline visit invoking the exclusion criteria.
738756|NCT01244503||
738757|NCT01244490||
738758|NCT01244477||
738759|NCT01244451||
738760|NCT01244425|95 participants were enrolled and screened. 23 were screen failures. 2 participants were discontinued due to: 1 was operated on by a surgeon other than the investigator, and the other underwent a prolonged operation- meaning that the investigational product (IP) could not be used. Therefore, 70 of the 95 enrolled were randomized.|
738761|NCT01244412||
738762|NCT01244243||
738763|NCT01244191|A total of 1048 participants who met all inclusion criteria and no exclusion criteria were enrolled between 11 Jan 2011 and 18 Jul 2012 at 140 sites in Europe, 78 sites in United States, 32 sites in Latin America, and 20 sites in Canada/Australia. Of the 1048 participants, a total of 1037 participants received treatment.|Participants were to be randomized in a 1:1 ratio to tivantinib at 360 mg BID (total daily dose, 720 mg) + erlotinib at 150 mg QD, or placebo BID + erlotinib at 150 mg QD, to be administered in a double-blinded manner.
738764|NCT01244126|Children scheduled for bilateral myringotomy and insertion of tubes at TCH from September 2008 to Feb 2011|1531 children screened, 1143 excluded as not qualifying, 217 declined to participate
738765|NCT01244061|This was a Phase 4, randomized, double-blind, placebo-controlled, parallel group, 2-arm, multicenter study. A total of 498 participants were randomized into the study at 36 investigator sites.|
738766|NCT01244035|The same participants in Part 1 were to continue in Part 2, pending the planned evaluation of Part 1 pharmacodynamic results. Based on the Part 1 results, no participants continued to Part 2.|
738767|NCT01243957||
738768|NCT01243944|Participants may be treated beyond 256 weeks due to the 14 day visit window.|
738769|NCT01243892||Due to slow enrollment, the study was terminated after screening 33 participants and enrolling only 18 participants, out of 480 planned participants.
738770|NCT01243775||
738771|NCT01243762||41 participants enrolled in Part 1 (dose escalation/preliminary maximum tolerated dose [MTD] identification). 12 participants continued in Part 2 (preliminary anti-tumor activity assessment), and 6 new participants were enrolled in Part 2 that did not participate in Part 1 (total enrollment = 47). Study terminated prior to completion of Part 2.
738772|NCT01243671||
738773|NCT01243619|Single arm open label pilot study. Study was expected to enroll five patients at Dana Farber Cancer Institute and Brigham and Women's Hospital. The study was initiated in August 2010 and the primary completion date was March 2013.|
738774|NCT01243580||
738775|NCT01243567||
738776|NCT01243450||
738777|NCT01243424|This multicentre, multinational, randomised, double-blind, double-dummy, parallel group,comparator-controlled trial compared Linagliptin versus (vs.) Glimepiride, predominantly on metformin background treatment in participants with type 2 diabetes mellitus (T2DM) at elevated cardiovascular (CV) risk receiving usual care.|All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be randomised to trial treatment if any one of the specific entry criteria were not met.
738778|NCT01243411||Includes all subjects who were enrolled and received at least 1 dose of study drug; subjects who were enrolled but not treated were excluded from the population
738779|NCT01243333||
738780|NCT01243320||
738781|NCT01243294|Subjects recruited from a user database in Denmark and through six hospital sites in France between august and november 2010|56 subject where enrolled, however two subjects did not comply to the in- and exclusion criteria and was hence terminated before testing any devices
738782|NCT01243268|Case report forms of subjects were retrieved from 34 investigators at 26 institutions|The study initiated on Dec 21, 2010, but the local health authority fixed the study period as August 19, 2010 to August 18, 2016
738783|NCT01243242|subjects recruitment was done in two medical centers Geha and Rambam during Feb 2011-June 2011.|subjects were screened for study eligibility according to the inclusion exclusion criteria. Each subject underwent a battery of rating scales including confirmation of ADHD diagnosis and exclusion of other psychological disorders.In addition medical history was checked and lab test and Electrocardiogram (ECG) were preformed.
738784|NCT01243177|This study started to enroll in April 2011 and concluded in August 2015.|Participant Flow refers to the Safety Analysis Set which is defined as all randomized subjects who took at least 1 dose of study medication and is identical with the Full Analysis Set.
738785|NCT01243151||
738786|NCT01243112|Subjects were recruited by hospital mailing list with 25 subjects enrolled over May 2010 until September 2010.|
738787|NCT01242813|The study was conducted at 6 centers in 3 countries.|A total of 29 participants were screened, out of which 20 were enrolled and exposed to study medication. Nine participants were considered as screening failures due to unacceptable laboratory value or test procedure results.
738788|NCT01242748|All participants who completed the main CS35 trial after initiation of the CS35A extension trial were eligible to enrol into CS35A.|Participants entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).
738789|NCT01242644||
738790|NCT01242527|The enrollment period started April 2011 and the last subject visit was February 2012. All subjects were qualified at the clinical site and eligibility was determined by each PI (74 US and International clinical sites).|Subjects who needed to washout omega-3 drugs/supplements or adjust or add a permitted statin, CAI or combination had an 8-week screening. All other subjects, including those on a stable statin, CAI or statin-CAI, or who needed to washout of bile acid sequestrants, fibrates, niacin and other lipid altering supplements had a 4-week screening period.
738791|NCT01242514|Total of 1917 enrolled patients: 1346, 357 & 214 were allocated to the 100 mg twice daily (bid), 150 mg once daily (qd) and 100 mg qd groups, respectively (1343, 357 & 212 received at least 1 dose of investigational product). As this was a long-term extension study no specific end date was given. As such no patients were recorded as completers.|A total of 5 patients did not receive treatment.
738792|NCT01242371|We enrolled n=65 participants drawn from rehabilitation and treatment programs in Central Maryland. Dates of recruitment 11/2010-01/2012.|We used a 2 week placebo run in for all participants prior to randomization. This placebo run in was followed by the 14 week double-blind treatment phase.
738793|NCT01242241|Patients were recruited in the operating room setting between the period of April 2008 to December 2011|A total of 213 patients were screened for study eligibility. Eighty-two patients were excluded; 51 did not meet inclusion criteria either becasue they declined participation, did not have intravenous access, were re-scheduled due to inadequate preparation for surgery or patient illness. All patients enrolled completed the study.
738794|NCT01242176||
738795|NCT01242111||
738796|NCT01242085|Participants were recruited from 6-2010 thru 6-2011 at the VA Palo Alto HCS|1 participant was excluded because withdrew prior to assignment
738797|NCT01242020||
738798|NCT01241916||
738799|NCT01241903||
738800|NCT01241760|This study evaluated the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with pegylated interferon and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.|The study was conducted between 15 November 2010 and 02 August 2012 and recruited participants from 125 study centers in 14 countries worldwide. 744 participants were initially enrolled and 740 out of them randomly allocated to the 2 treatment arms.
738801|NCT01241604|Patients were recruited from one site to evaluate software enhancements. The study enrolled patients in the spring of 2009.|
738802|NCT01241591||
738803|NCT01241565||
738804|NCT01241552||Participants 18 years of age or older, with a diagnosis of Clostridium difficile Infection (CDI) were enrolled in this trial.
738805|NCT01241539||This was an open-label, 2-period, fixed-sequence, multiple dose trial. On Day 1, all patients were treated with Dabigatran 150 mg, on day 2, with 110 mg at 10:00, and on day 3, 75 mg 8 h before dialysis. The target blood flow rate on day 3 of period 1 was 200mL/min, whilst that in period 2 was 400mL/min.
738806|NCT01241513|2 participants withdrew prior to any testing|
738807|NCT01241461||
738808|NCT01241448||
738809|NCT01241435||
738810|NCT01241318|In the 90 clusters (i.e. government-run health facilities), pregnant women who met eligibility criteria attending antenatal care were offered enrollment. Recruitment started February 15, 2011 and ended January 30, 2013.|Mothers were enrolled in the study while pregnant and infants were enrolled after delivery; thus the total protocol enrollment is women + infants. Study reporting is completed at the woman level and thus the total enrolled is listed at the woman level in the outcomes tables.
738811|NCT01241292||Seven participants were enrolled and 6 entered the treatment period. Reason for 1 participant not entering treatment period: participant no longer met study criteria.
738812|NCT01241279|A total of 6 subjects (11 eyes) were enrolled at one investigational site in the US. First participant enrolled 10/26/2010; last participant visit 12/01/2011.|Due to the small sample size, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.
738813|NCT01241240||
738814|NCT01240915||
738849|NCT01238861||Participants were stratified based on the protocol defined eosinophilic phenotype (EOS+ versus EOS-) and inhaled corticosteroid (ICS) use during a 3-week screening period. A total of 964 participants were screened out of which 609 were randomized in the study, and of which 606 participants received at least one dose of investigational product.
738850|NCT01238848||
738851|NCT01238835|One patient withdrew from the study prior to procedure and one patient did not continue to procedure due to poor health.|Two enrolled subjects did not enter the procedure room.
738815|NCT01240902|Between Feb 17, 2011 and Aug 23, 2013, 656 subjects were enrolled into the CoreValve US Pivotal Trial Extreme Risk study at 41 of the 43 activated centers in the United States. Between February 2, 2011 and July 23, 2013, 797 subjects were enrolled into the CoreValve US Pivotal Trial High Risk study at 45 centers in the United States.|The first 3 successfully enrolled and implanted iliofemoral subjects at each implanting site, inclusive of both the High Risk Surgical and Extreme Risk patient populations were considered roll-in subjects, and were automatically assigned to undergo Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI).
738816|NCT01240863|A total of 519 patients with osteoarthritis or low back pain were screened for enrollment into the study; of these, 391 patients at 71 centers in the US met entry criteria and were enrolled into the titration period of the study.|Of the 389 patients enrolled and treated during the titration period, 294 (75%) patients identified a successful dose and therefore completed the open-label titration period, and were randomly assigned to receive hydrocodone extended-release (ER) tablets (146 patients) or placebo (148 patients) in the double-blind treatment period.
738817|NCT01240811|Participants were recruited from the medical clinic and our database of prior research participants. Public advertisements included listing on our website, letters to the database mailing list, flyers placed on local college campuses, mailings to faculty, internet postings on Craig's list, and informational booths at on or off campus fairs.|
738818|NCT01240785||
738819|NCT01240746|The study participants were enrolled from 11 November 2010 to 20 June 2011 in 69 clinical centers in the US|A total of 4363 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
738820|NCT01240590||The phase II portion was not completed because it was impossible to recruit.
738821|NCT01240551||
738822|NCT01240382||Informed consent was obtained from 332 patients, of whom 287 were randomized and prescribed the study drug.
738823|NCT01240356||
738824|NCT01240330|Study Duration: 4 days First subject enrolled: August 31, 2010 Last subject completed: September 3, 2010|No enrolled participants were excluded from the study.
738825|NCT01240304||
738826|NCT01240200|Enrollment of subjects started in January 2011 and all study participation was completed in December 2012. Patients were recruited from the Grady Memorial Hospital Diabetes Clinic in Atlanta, Georgia.|Of the 56 individuals who consented to take part in the study, 7 were removed prior to being randomized to a group (2 did not meet eligibility criteria and 5 withdrew consent prior to group assignment). Those who were not randomized were not considered to be enrolled in the study as group assignment was never determined.
738827|NCT01240135|Subjects were recruited from 5 US study centers.|
738828|NCT01240122||
738829|NCT01239992||
738830|NCT01239797|Study initiated: June 2011; Study Completion: Study on-going|761 participants were enrolled and 646 participants were randomized (321 Lenalidomide with Elotuzumab, E-Ld and 325 Lenalidomide, Ld). 635 were treated (318 Lenalidomide with Elotuzumab, E-Ld and 317 Lenalidomide, Ld). Reason for non-treatment include 11 non-specified reasons.
738831|NCT01239745||
738832|NCT01239732||This study has been completed. However, the efficacy and safety results up to the clinical database cutoff date of 07 December 2014 are provided.
738833|NCT01239680|Recruitment period started 01/12/2011. Recruitment ended 11/01/2013. Subjects were recruited from the Emergency Department and Intensive Care Units at Truman Medical Center Hospital Hill. These subjects were Trauma Activations. Recruitment was performed by the Principal Investigator, Research Coordinator, or other approved study staff.|
738834|NCT01239511|The recruitment period was from Nov. 2010 through Apr. 2012. There are 5 study sites participated in this study, including National Taiwan University Hospita, Chi Mei Medical Center, Taipei Veterans General Hospital, Taipei Medical University-Shuang Ho Hospital and Kaohsiung Medical University Chung-Ho emorial Hospital.|In order to ensure the consistency, the difference of total exercise time between V1 and V2 should be less than 20%.
738835|NCT01239472||
738836|NCT01239394||The number enrolled (43) and number starting study (42) do not match because one patient never began study treatment due to an acute stroke prior to any study treatment.
738837|NCT01239381||
738838|NCT01239368||For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the max. number that could be manufactured due to limiting reagents for cell culture. 3/34 pts signed consent but did not receive therapy due to progressive malignancy.
738839|NCT01239355||
738840|NCT01239342|Recruitment Period: January 27, 2011 to January 9, 2013. All recruitment done in medical clinic settings.|
738841|NCT01239316|This study was distributed to the sites on 11/22/2010, and received the first IRB approval on 02/02/2011. It was closed to accrual on 03/25/2015. As of the closure date, 42 patients have been pre-screened for Hh pathway activation. Of the 42 patients, 9 patients with Hg pathway activated tumors were registered.|There were three patients treated at the MTD of GDC-0449 on PBTC-025 who had Hh pathway activated tumors and who met the eligibility criteria for PBTC-032. These three patients were included in the assessment of the primary objectives for PBTC-032.
738842|NCT01239212|Recruitment was from 9/2010 to 8/2011 from the NICU at Cincinnati Children's Hospital.|
738843|NCT01239160||
738844|NCT01239121||
738845|NCT01239056||There were 22 signed informed consents, however after Endoscopic ultrasound imaging, 2 participants were excluded due to characteristics of the cyst cavity. Therefore, 20 participants underwent transgastric drainage of pancreatic pseudocysts by use of the fully covered self-expanding metal stents (CSEMS).
738846|NCT01239043|Participants were enrolled from 08 November 2010 to 16 December 2010 at 6 US clinical centers.|A total of 139 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
738847|NCT01238991||The study enrolled those who completed the preceding studies (NCT00752232 and NCT00959192), where active vaccine ACC-001 (3, 10 or 30 μg) + adjuvant QS-21 (50 μg), as well as ACC-001, QS-21 and phosphate buffered saline (PBS) alone, were administered at Day 1, month 3, 6, 9 and 12 and at Day 1, month 1, 3, 6 and 12, respectively.
738848|NCT01238900||
738899|NCT01235975||Out of the total number of subjects originally enrolled, only 369 subjects were eventually found to be eligible to be included in the Total Vaccinated Cohort.
738852|NCT01238822|Children were recruited through multiple community and clinical sources including schools and local practitioners to participate in a study of the effects of medication on cognitive functioning. Diagnostic status was determined using methodology similar to that employed by the Multimodal Treatment Study of ADHD (MTA Cooperative Group, 1999).|
738853|NCT01238640||
738854|NCT01238588||24 patients enrolled in the study by signing the consent form of which 12 started the study. The other 12 never started the study due to various reasons (eg voluntary withdrawal, termination due to infection, transplant).
738855|NCT01238575||81 total patients screened. 13 ineligible. 6 Declined
738856|NCT01238549|"Participants recruited from SCI Clinics at the James J. Peters Veterans Affairs Medical Center, Bronx, New York and the James A. Haley Veterans Hospital, Tampa, Florida.
~284 participants signed consent. 248 participants completed the Quality of Life questionnaires."|
738857|NCT01238536||
738858|NCT01238471||
738859|NCT01238341||
738860|NCT01238211|Between April 2011 and January 2013, 61 participants were recruited.|
738861|NCT01238172||Of 602 total patients were pre-registered, only 478 patients were deemed eligible and randomized.
738862|NCT01237951|Participants were enrolled at the University of Texas MD Anderson Cancer Center. Out of 75, 1 participant died before starting the treatment.|
738863|NCT01237899||
738864|NCT01237821||
738865|NCT01237678|Participants were recruited from, and treated at, 45 study sites in the U.S., Canada, Spain, and the U.K. between November 2010 and May 2015.|Patients were screened during a 28-day period
738866|NCT01237613||
738867|NCT01237587|13 week Double-Blind Treatment Phase (Acute Phase), followed by 26 week Open-Label Extension Treatment Phase (Extension Phase), followed by 1 week Taper/Discontinuation Phase.|
738868|NCT01237353|Healthy volunteers were recruited to one clinical site in the U.S.|Hypochlorhydria was induced through the administration of 20mg oral rabeprazole twice daily with food for four days prior to study day
738869|NCT01237340||
738870|NCT01237327||Follow-up study for participants in core study who completed 26 weeks of treatment, progressed while on therapy, or dropped out for any reason. Those who benefitted from core study treatment continued according to original randomization. Those who dropped out of core study received therapy appropriate for disease and were followed for survival.
738871|NCT01237301|Recruitment Period October 29, 2010 through November 25, 2011. Study Location: Clinic|
738872|NCT01237223||
738873|NCT01237197|Participants were recruited from the University of Minnesota, Amplatz Children's Hospital Pediatric Weight Management Clinic in Minneapolis or the McNeely Pediatric Diabetes Center and Endocrinology Clinic, Children's Hospitals and Clinics of Minnesota in St Paul.|
738874|NCT01237080|The study was conducted from September 2010 to January 2011. Patients were recuted from two hospitals.|Exclusion: severe mental disorder, greater alcohol consumption than recommended by the Danish Health Authority, drug abuse, previously impossible mask ventilation or intubation with the GS and/or FT, the need for RSI and if the anaesthetist responsible determined that the patient should be treated differently than described in the protocol.
738875|NCT01237054||
738876|NCT01237041||Of 37 enrolled, two withdrew from the study before being studied. 16 were ineligible. 7 subjects completed the first niacin dose-establishing protocol. 5 completed the second phase pilot study. A total of 5 subjects were randomized in the main study. Two subjects were eligible, but were never studied due to unavailability of study medications.
738877|NCT01236768||
738878|NCT01236755||
738879|NCT01236742||
738880|NCT01236534|Recruitment occured in the Multiple Sclerosis Clinic at the University of Rochester, which began on 08/30/2010 until the last subject was enrolled on 12/27/2011.|After inclusion criteria and screening, subjects were instructed to D/C all over the counter and Rx bowel medications except for fiber supplements for 14 days. Any subject with >2 BM/Week were excluded. 40 patients screened and 21 randomization, 18 were ineligible D/T a high baseline SBM count, and 1 was unable to reschedule.
738881|NCT01236391||One hundred fifteen subjects were enrolled and 111 subjects received at least 1 dose of ibrutinib and constitute the all treated population and the safety analysis set.
738882|NCT01236365||
738883|NCT01236339||
738884|NCT01235923|Infants ≤1,500 grams and ≥7 days of age hospitalized in the NICU at UNM between 4/06 and 3/09 were randomized to once weekly Epo, 1,200 units/kg/dose, or thrice weekly Epo, 400 units/kg/dose, subcutaneously for 4 weeks, along with iron and vitamin supplementation.|
738885|NCT01235793||
738886|NCT01236573||
738887|NCT01236560||After one-year EFS, neither Vorinostat nor Bevacizumab were found superior to temozolomide, therefore Phase III portion of the study did not occur.
738888|NCT01236521||
738889|NCT01236378||
738890|NCT01236352||98 participants were enrolled and 84 participants were treated. 14 participants did not enter treatment period (13 no longer met study criteria and 1 due to other reasons). 42 entered Phase 1 and 42 entered Phase 2
738891|NCT01236326||
738892|NCT01236300||
738893|NCT01236196||41 veterans were enrolled, but 2 dropped out before being randomized to treatment condition and did not receive either treatment.
738894|NCT01236170||
738895|NCT01236118||Eligible participants must have completed Study I1F-JE-RHAL (NCT01253265) to meet the enrollment criteria of this study.
738896|NCT01236105||
738897|NCT01236053|Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.|"Actual number of patients may be less, as it is possible for a patient to be represented in more than 1 of the 22 arms (See Participant Flow: Overall Study Table) because of the risk set sampling."
738898|NCT01236001|This observational study began enrollment in September 2010. The last patient visit occurred in March 2012. There were 22 study sites in Belgium.|The Safety Set (SS) and Full Analysis Set (FAS) both consisted of 192 subjects. The SS consisted of all enrolled subjects who received at least one dose of VIMPAT (before or during the study). The FAS consists of all enrolled subjects.
738901|NCT01235949|Among the 850 subjects enrolled in the study, 35 subjects were excluded for lack of confidence in the integrity of the data and 3 subjects were allocated with subject number but didn't receive any vaccination.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
738902|NCT01235910||
738903|NCT01235897|Patients were enrolled on the study between April 2011 and January 2013. This is a phase one study; the number enrolled was guided by ongoing toxicity assessment.|17 patients were initially enrolled; however, one participant experienced rapid progression of disease before receiving any study treatment.
738904|NCT01235741|5 January 2011 Lead-In Period started. 28 September 2011 last participants final visit procedure. Clinics where participants with body mass index [BMI] greater than, equal to (≥)35 kilogram per meter squared (kg/m^2) and less than, equal to (≤)45 kg/m2) could be enrolled.|6 week lead-in period:low-calorie diet (LCD); 16 week randomized treatment period: participants who lost >=2% body weight at end of LCD were randomized to an arm. Sponsor terminated study during randomization period due to neutralizing activity to metreleptin observed in Study DFA102, NCT00673387. Safety follow-up 2, 4, 6 months post treatment.
738905|NCT01235728||
738906|NCT01235715|Patients undergoing total knee arthroplasty at the Hospital for Special Surgery from September 2010 to June 2012 were enrolled in a consecutive prospective manner on a voluntary basis.|
738907|NCT01235689|"This study was conducted at 59 sites in Canada, European Union, Israel, Japan, Russia, South Africa, Switzerland, Turkey, and the Ukraine.
~The study included a screening period, up to 8 weeks of prednisone run-in treatment, a 48-week post-randomization treatment period, and a 70 day follow-up phone call or clinic visit."|"A total of 252 participants were enrolled and received study treatment, of whom
~165 entered the prednisone run-in
~157 randomized (45 prior to Week 9, 112 at Week 9)
~8 discontinued prior to randomization.
~87 randomized at Baseline.
~Randomization was stratified by smoking status, weight, and disease duration."
738908|NCT01235598|The Participant Flow refers to the Randomized Set (RS) population which consists of all subjects randomized into the study.|The study population consists of subjects with a diagnosis of adult-onset Rheumatoid Arthritis of at least 3 months duration but not longer than 15 years. In addition, subjects must be on Disease Modifying Anti-Rheumatic Drugs (DMARD) therapy for at least 12 weeks with a stable dose / route of administration for at least 8 weeks prior to Baseline.
738909|NCT01235546|Patients were randomly assigned to receive either azithromycin (at a dose of 500mg in 250 ml of saline, one time dose) or an identical-appearing saline placebo and the standard of care (cephazolin or clindamycin)|The addition of azithromycin and the standard of care (cephazolin or clindamycin) for antibiotic prophylaxis before cesarean delivery may further reduce the rate of postoperative infection. We evaluated the benefits and safety of azithromycin prophylaxis and the standard of care in women undergoing nonelective cesarean section.
738910|NCT01235507||
738911|NCT01235442|Participants were enrolled from 15 September 2010 through 17 October 2011.|
738912|NCT01235403|This is a 24-week study, which enrolled 100 patients at 44 sites in France.|"The study comprises a 12-week Titration Phase and a 12-week Maintenance Phase; both phases together are regarded as the 24-week Treatment Period.
~Participant Flow and Baseline Characteristics refer to the Safety Set (SS). The SS includes all subjects that received at least one dose of study medication."
738913|NCT01235377||
738914|NCT01235351|335 patients from 32 sites were enrolled from October 2010 until September 2011.|335 patients enrolled, 2 patients not genotyped 333 patient allocated to initial treatment with 75 mg and 150 mg clopidogrel
738915|NCT01235338||Of the 80 randomized subjects, 3 did not receive any investigational product and therefore were not included in the Safety Analysis/Pharmacokinetic Analysis Sets (n = 77).
738916|NCT01235234||
738917|NCT01235195||
738918|NCT01234922|Protocol was closed early due to slow accrual|
738919|NCT01234883||
738920|NCT01234870||
738921|NCT01234831||
738922|NCT01234766||
738923|NCT01234714|Patients that underwent liver surgery were recruited at the outpatient clinics.|
738924|NCT01234675||
738925|NCT01234649|153 met criteria and were randomized|166 were consented but 153 met criteria
738926|NCT01234467|23 patients were enrolled between March 2011 and May 2013.|28 patients were assessed for eligibility; 4 patients were excluded for not meeting the inclusion criteria and 1 patient eventually declined to participate. Leaving 23 patients enrolled.
738927|NCT01234402|Participants in Capecitabine arm were allowed to cross-over to ramucirumab or icrucumab in combination with capecitabine, after radiographic disease progression while on capecitabine.|Completers are those participants who died or alive and on study at conclusion but off treatment.
738928|NCT01234350|A total of 136 sites in 15 European countries (Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Slovakia, Switzerland, United Kingdom) recruited subjects to this observational study between January 2011 to April 2013, and the last subject completed the last visit in March 2018.|A total of 1,515 subjects were screened, of which 1,493 subjects were found to be eligible and exposed to treatment; 1,000 subjects in the FIRMAGON group and 493 subjects in the gonadotrophin releasing hormone (GnRH) agonist group.
738929|NCT01234337|At 154 sites in 22 countries, participants with histologically or cytologically confirmed human epidermal growth factor receptor 2 (HER2)-negative adenocarcinoma of the breast, and locally advanced or metastatic disease, were screened.|Of 707 participants screened, 537 participants were randomized and 527 participants received at least 1 dose of study treatment. The reasons for 170 screen failures were adverse event in 21 participants, disease progression, recurrence or relapse in 2, consent withdrawn in 16, death in 4, and protocol violation in 127 participants.
738930|NCT01234207|Presbyopic subjects were recruited from the population of patients who were purchasing non-free-form PAL spectacles with antireflective coating in new frames from the University of California, Berkeley School of Optometry Eyewear Center.|95 subjects were recruited, all of whom met the eligibility criteria and completed the study.
738931|NCT01234103||
738932|NCT01233999|10 subjects recruited from Emory Dept of Dermatology|all subjects were assigned to group
738933|NCT01233921|Subjects were enrolled between Nov 2010 and June 2012 during outpatient follow-up after allogeneic hematopoietic cell tranpslantation.|
738935|NCT01233817|Participants were recruited from May 2010 until February 2012. Some participants were recruited during clinic visits and others contacted us after being informed of the study|This was a pilot study and all participants were in the treatment group
738936|NCT01233726|This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-adquired infection in critically ill, hyperglycemic patients on mechanical ventilation (MV)|The study was performed over the period April 2010 to May 2012. A website was constructed to record data and to randoize patients to each EN formula. Data were collected online using an electronic case report form.
738937|NCT01233687||
738938|NCT01233609||
738939|NCT01233284|A total of 149 patients were randomised and treated, 141 patients completed the trial.|Randomised, double-blind, placebo controlled, cross-over design without washout phase between the four periods. Patients were randomized to one of the 4 sequences (ABCD, DCBA, BDAC, CADB). For one patient treatment 2 and treatment 3 were interchanged (resulting sequence DBCA).
738940|NCT01233258|Participants were recruited from specialized hemophilia treatment centers.|83 participants were randomized, but 3 of these terminated the study before their first injection of study drug.
738941|NCT01233232|First patient enrolled: 22 November 2010. Last patient completed: 22 March 2011. Fifteen centres across 4 countries participated in this study: Bulgaria (4), Germany (4), Hungary (4) and Ukraine (3)|22 patients enrolled were not randomized due to eligibility not fulfilled (17 patients) and voluntary discontinuation (5 patients)
738942|NCT01233076||This reporting group includes all enrolled and dispensed participants.
738943|NCT01233050||
738944|NCT01232946||
738945|NCT01232920||
738946|NCT01232894|90 participants were screened and enrolled into the study. The participants were randomized in a 2:1 ratio. Out of 90 participants randomized, 87 received study drug and were included in the Safety set for analysis.|
738947|NCT01232868|Atlanta Metropolitan Area 2010-2011|"There were 4 screen failures :
~one unable to obtain blood pre-vaccination
~two with elevated blood pressure readings
~one with progressive medical illness"
738948|NCT01232829|This was a phase II, single-arm study. From December 2010 to May 2012, a total of eighteen patients were enrolled at the University of Colorado Cancer Center and Johns Hopkins Hospital.|Subjects were eligible if they were at least 18 years old, had a Karnofsky Performance Status of ≥70, at least one previous chemotherapy for metastatic disease, histologically or cytologically metastatic adenocarcinoma of the pancreas, and measurable disease. Patients with islet cell neoplasms and locally advanced disease were excluded.
738949|NCT01232790||
738950|NCT01232738||
738951|NCT01232569||Of the 656 patients randomized into the study (437 to the tocilizumab arm and 219 to the placebo arm), 438 patients received tocilizumab as their first dose and 218 received placebo as their first dose because of a dose administration error with 1 patient.
738952|NCT01232556||
738953|NCT01232504||
738954|NCT01232491|The trial was conducted at 110 sites in 9 countries: Argentina (5), Germany (7), Poland (4), Serbia (4), Slovakia (3), Slovenia (2), Spain (4), Turkey (5) and United States of America (76).|Subjects continued on their treatment with metformin, at the pre-randomisation dose level and dosing frequency. All other oral antidiabetic drugs were discontinued before insulin detemir was used.
738955|NCT01232465|Recruitment occured at the Center for Human Reproduction under an IRB waiver of informed consent for participation.|
738956|NCT01232452||Completers are those participants who died or had progressive disease (PD).
738957|NCT01232296||165 Participants were screened and randomized. However 3 participants discontinued prior to recieving study drug. The number enrolled in the protocol section reflects the randomized participants who received study drug.
738958|NCT01232283|The study was conducted at 46 study centers in 9 countries.|Participants were eligible who had moderate to severe plaque psoriasis.
738959|NCT01232205|Recruitment started in June 2001 and completed in December 2009, Department of Obstetrics and Gynaecology, University of Indonesia, at Cipto Mangunkusumo National Hospital|There were 110 (65.4 percent) eligible subjects from 168 pregnant women, because of ferric reducing ability of plasma (FRAP) level measured
738960|NCT01232127||
738961|NCT01231984|A total of 380 subjects were screened from the current diabetic patient population at 10 research centers in the US. Of those, 293 subjects met eligibility criteria and were enrolled in the wash-in period.|Subjects who successfully completed the wash-in period and agreed to participate were further randomized into one of the study arms. Specifically, 274 of 293 subjects who were enrolled in the wash-in period completed the wash-in period and were randomized into one of the two study arms.
738962|NCT01231841|Patients with severe aplastic anemia were recruited over a period of four years (2005-2009) in the hematology clinic at the Cleveland Clinic, a hospital in Cleveland, Ohio.|
738963|NCT01231750|Recruitment goal not met.|Inclusion and exclusion criteria proved a large screening volume to yield few participants.
738964|NCT01231646||
738965|NCT01231633||
738966|NCT01231620||Male and female adult and adolescent participants >=16 years of age hospitalized with documented influenza or suspected influenza were eligible for enrollment. A total of 626 participants were randomized, and 615 participants were included in the Intent-to-Treat Exposed (ITT-E) Population (pop)
738967|NCT01231607||
738968|NCT01231581||
738969|NCT01231555|This study was conducted from 18 November 2010 to 04 July 2011. A total of 150 human immunodeficiency virus (HIV)-1 infected adult participants naïve to antiretroviral therapy (ART) were planned to be enrolled.|Enrollment was terminated prematurely due to safety findings. At the time of enrollment termination, 23 participants were enrolled who continued into this study. At least 5 interim analyses were planned up to Week 48, however, the study was terminated prior to any of these analyses being conducted.
738970|NCT01231516||1441 participants were screened; 724 were randomized. A total of 719 participants received at least 1 dose of study medication and comprised the intent-to-treat exposed (ITT-E) population. Four participants from one closed site were removed from the ITT-E population creating the modified ITT-E population with 715 participants.
739049|NCT01227395|This was a phase 4, observational, open-label study conducted in participants who were prescribed azithromycin by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.|
738971|NCT01231503|480 subjects were enrolled into the study. Out of these 480 subjects, 479 were vaccinated and 1 was allocated a subject number but was not vaccinated.|480 subjects were enrolled into the study. Out of these 480 subjects, 479 were vaccinated and 1 was allocated a subject number but was not vaccinated.
738972|NCT01231464||
738973|NCT01231412||
738974|NCT01231399||
738975|NCT01231373||Three (3) patients were randomized but never treated.
738976|NCT01231334||
738977|NCT01231321||
738978|NCT01231230|Subjects were recruited from our Asthma Database. Subjects with asthma who are in our database have previously agreed to serve as potential subjects in future studies. These subjects have signed an informed consent (approved by UM IRB) to be included in this database.|
738979|NCT01230931||26 were enrolled, but only 20 were randomized.
738980|NCT01230892||
738981|NCT01230827||
738982|NCT01230814||
738983|NCT01230801||
738984|NCT01230788|One participant recruited between September 2010 and June 2011 at Children's Healthcare of Atlanta.|
738985|NCT01230749|89 participants were enrolled at 7 study sites in United States.|89 participants were randomly assigned to 4 treatment groups (Placebo: 22; Pioglitazone 30 mg: 22; JNJ41443532 250 mg: 23, and JNJ41443532 1000 mg: 22) and all participants received at least one dose of the study medication.
738986|NCT01230710||
738987|NCT01230593||
738988|NCT01230554||
738989|NCT01230502||"11 participants consented and were enrolled in the study. However, 2 of the subjects screen failed and did not participate in the study beyond providing their consent to participate. Thus only 9 subjects consented to and started the study and these 9 subjects are analyzed in the results."
738990|NCT01230489|13 participants were recruited from surgical clinics.|Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
738991|NCT01230424||
738992|NCT01230307||16 consented participants were not randomized due to screen fails.
738993|NCT01230177||
738994|NCT01230125||
738995|NCT01230060|This study was conducted at 6 clinical sites in the US. Study started Aug 2010 and was completed June 2011.|122 subjects underwent cataract extraction and implantation of the Bausch + Lomb Intraocular Lens (IOL) for the correction of aphakia.
738996|NCT01230021|The trial was conducted at five sites located in the UK (2 sites), Israel (1 site) and the US (2 sites).|Between screening and treatment with trial drug the children were assessed for eligibility. If eligible, the children were treated with one single dose of FXIII. The trial was not randomised.
738997|NCT01229943|From October 2010 to October 2012, 150 participants were recruited and randomized to study treatment.|
738998|NCT01229891||
738999|NCT01229735|447 subjects were screened, 343 subjects were randomized.|Participant Flow refers to the Randomized Set which consists of all subjects who were randomized in this study.
739000|NCT01229722|Patients receiving HIV care at Boston Medical Center were eligible to participate if they were 18+ years of age and prescribed an ART regimen for at least 90 days. Participants were recruited between 2011-2012 during their doctor visit and/or via study flyers in the clinic. Eligibility was confirmed in person or via telephone pre-screening.|
739001|NCT01229527||
739002|NCT01229462||
739003|NCT01229449|Subjects were recruited in three centres, Salt Lake City (243 subjects randomised), San Marcos (229 subjects randomised) and Austin (206 subjects randomised)|A total of 678 subjects were randomised into the study.173 subjects received ibuprofen 200 mg + paracetamol 500 mg, 169 subjects received Nurofen Plus®, 168 subjects received ibuprofen 400 mg + paracetamol 1000 mg, 113 subjects received Panadeine® Extra and 55 subjects received placebo.
739004|NCT01229436||
739005|NCT01229423||
739006|NCT01229410||Patients were enrolled in groups by planned time of pars plana vitrectomy (Week 2, 4, or 8 post-implant). Patients who had the implant removed during the vitrectomy did not complete the 6 month follow-up per protocol.
739007|NCT01229397|Recruitment period: 05 October - 17 January 2011; Location: University of Milan|
739008|NCT01229371|Recruitment period: 19 October 2010 to 09 November 2010; outpatient study|
739009|NCT01229267|Adult participants scheduled to undergo Autologous Hematopoietic Cell Transplant (auto-HCT) within 60 days were enrolled at 150 sties|A total of 1323 participants were screened and 1257 were randomized. Twenty-seven randomized participants were removed from all analyses due to the identification of major Good Clinical Practice compliance issues at a single site.
739010|NCT01229254|Between 9Sep10 & 22Apr11, 189 patients were enrolled by 68 study centers in 2 countries (USA, Canada). Patients were enrolled to 1 of 3 treatment groups (betrixaban once daily 30, 60 or 90 mg) based on weight or use of amiodarone at screening. The study had an initial pharmacokinetics (PK) phase of 4 weeks and a safety extension phase of 20 weeks.|Patients weighing < 80 kg received daily betrixaban 60 mg, patients weighing ≥ 80 kg received daily betrixaban 90 mg, and patients on amiodarone at screening, regardless of weight, received daily betrixaban 30 mg. 241 patients were screened for study participation. Of these patients, 189 were enrolled and received at least 1 dose of study drug.
739011|NCT01229228||
739012|NCT01229176||
739013|NCT01229150||89 participants were enrolled and 79 participants started. 10 patients should be classified as screen failures. Of the 10, one died during the screening process, and one patient withdrew during the screening process.
739014|NCT01229111|Patients were recruited from hospitals in Cleveland and Columbus, Ohio from October 2010 through February 2013.|
739015|NCT01228968|we recruited subjects currently enrolled in related studies.|
739016|NCT01228929||
739017|NCT01228903||
739018|NCT01228747|This study started to enroll subjects in Japan and China in October 2010.|Participant Flow refers to the Randomized Set consisting of all screened subjects who signed the Informed Consent form, participated in the prospective Baseline Period and were randomized at Visit 2.
739050|NCT01227382||
739051|NCT01227278|A total of 421 participants were screened and 101 participants were randomized into the study.|
739019|NCT01228734|The study was planned to enroll subjects with Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type (wt) tumors.Following modification of approved EU indication of cetuximab,a decision made to amend study population from subjects with KRAS wt tumors to those with RAS wt tumors. All efficacy/safety analysis based on subjects with RAS wt tumor.|First subject first visit/last subject last visit: 30 September 2010/31 Jan 2018. A total of 553 subjects were enrolled in the trial. 504 subjects were randomized in the study, of which 397 were with RAS wt tumors. Participant Flow is presented for the subjects with RAS wt tumors.
739020|NCT01228591|This is a 3 site, 3 visit, randomized, double-masked, bilateral crossover trial comparing Acuvue Advance to Acuvue Advance Plus lenses.|Of the 38 subjects enrolled, 2 were ineligible and not-randomized, 3 discontinued, and 33 completed as cohort.
739021|NCT01228435|Patients were recruited from the oncology clinic at Mass General from 6/10/10 to 9/26/11.|The study was closed to accrual after 3 patients were enrolled over a 1-year period. It was determined that there were too many competing protocols and completion of the study as designed was not feasible.
739022|NCT01228318|At the Grady Hospital Infectious Disease Clinic 343 subjects were assessed for eligibility and 280 were excluded. 63 viremic treatment-naïve adult HIV-infected subjects were randomized in a double-blinded, placebo-controlled study (ART+placebo N=29; ART+Zoledronic acid N=34). Participants were enrolled between January 2011 and August 2014.|
739023|NCT01228175||
739024|NCT01228149||
739025|NCT01228084||
739026|NCT01228071|This multicenter, open-label, single-arm phase 3B trial was initiated on November 9, 2010 and completed on May 6, 2011 in the United States.|After the 3-week screening period and fulfilling the eligibility criteria, 34 hypogonadal men were enrolled in the study.
739027|NCT01228019|1,166 participants who were currently using niacin (+) laropiprant (TREDAPTIVE) for treatment of primary hypercholesterolemia or mixed dyslipidemia were enrolled and their case report forms were collected. Enrollment was stopped early due to termination of all studies involving TREDAPTIVE.|A completer was considered a participant eligible for safety population. Efficacy population was a sub-population of the safety population
739028|NCT01227993||
739029|NCT01227980||
739030|NCT01227967|Outpatient or hospitalized participants at high risk for complications and morbidity, diagnosed with influenza by rapid antigen or PCR were recruited at 65 sites from 5 countries: 52 from the U.S., 2 from Australia, 3 from Mexico, and 4 each in Thailand and Argentina, between March 2011 to April 2016.|Eight hundred eighty-one subjects were enrolled per protocol (signed consent). Two hundred fifty-one subjects were excluded during screening and did not participate in any other aspect of the trial. Three subjects were randomized improperly because they were given study drug kit prior to the randomization.
739031|NCT01227954||
739032|NCT01227928||
739033|NCT01227902|Study 113905 was an open-label, multi-center, multi-country study of retigabine using a flexible dosing regimen in adult participants (>=18 years old) with partial-onset seizures. Eligible participants must have been taking one of the following antiepileptic drug treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid.|Eligible participants were required to have had at least 4 partial seizures during the 8-week Baseline Phase and must have been receiving a stable dose of one of the prespecified monotherapy antiepileptic drug treatments.
739034|NCT01227889|This was a Phase III randomized, open-label study to compare GSK2118436 to Dacarbazine (DTIC) in previously untreated participants (par.) with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma. This study was conducted at 70 centers in 12 countries.|The study has 2 phases: Randomized and Crossover Phase. In Randomized Phase, a total of 250 par. were randomized in 3:1 to receive either oral dabrafenib 150 mg twice daily (BID) or intravenous DTIC 1000 milligram/meter square. Par. in DTIC arm with disease progression were considered for crossover to dabrafenib arm in Crossover Phase
739035|NCT01227824|This was a randomized, parallel group, non-inferiority study to demonstrate the antiviral activity of Dolutegravir. Participants were enrolled from 9 countries. Participants in Dolutegravir arm who completed 96 Weeks double-blind phase continued to receive Dolutegravir in open-label phase, until dolutegravir was locally available commercially.|Total 1035 participants were screened; 827 participants were randomized, and 822 participants entered the treatment period. Of the 5 participants who were randomized but not treated with investigational product, 4 withdrew consent and 1 was randomized in error. 338 participants were enrolled in open label phase to receive Dolutegravir.
739036|NCT01227785|Recruitment period: Nov2010 - Feb2011|
739037|NCT01227707||
739038|NCT01227681|Parkinson's disease research center, Tzu Chi Hospital|No participants were randomized to receive 1.65ug/kg/day of G-CSF and placebo
739039|NCT01227668||Of 215 participants enrolled, 58 discontinued during screening and before entry into Phase 1. Of the 58 who discontinued, 1 withdrew for an adverse event, 12 withdrew consent, 8 were lost to follow-up, 36 no longer met study criteria, and 1 withdrew for other reason.
739040|NCT01227655||
739041|NCT01227629||
739042|NCT01227616||"A total of 296 hemodialysis patients with IDA who met the entry criteria were enrolled and randomized (ferumoxytol: n=197; iron sucrose: n=99).
~One subject in the ferumoxytol group and 2 subjects in the iron sucrose group withdrew prior to receiving study drug, resulting in 293 total participants for analysis."
739043|NCT01227577||
739044|NCT01227564|Twenty study centers in the United States of America participated. One of these did not enroll any participants.|Participants, who were found eligible, were randomized to 1 of 3 groups in a 1:1:1 ratio between ACC-001 3 μg+QS-21, or ACC-001 10 μg+QS-21, or placebo (which was administrated as phosphate buffered saline [PBS]). The study randomization was stratified based on apolipoprotein E (Apo E) genotype (E4 carrier or non-carrier).
739045|NCT01227551|Subjects were recruited from medical clinics from 27-Dec-2011 to 29-Jul-2015 (last subject enrolled in VLA-008).|Subjects were screened for and excluded from the study if they had pre-existing antibodies to CVA21.
739046|NCT01227512|A total of 191 participants were recruited at 81 study sites in the United States (US). A total of 124 participants were randomised to treatment.|Participants randomized 1:1 to tolvaptan (15 mg/day,titrated to 30 mg/day or 60 mg/day) without fluid restriction or placebo with titrated fluid restriction (500 to 1500 mL/day). Stratified based on severity of baseline symptoms (3-4, or 5-6 on the Clinical Global Impression of Severity and study center. All partipants were blinded to treatment.
739052|NCT01227265|Adult participants with a diagnosis of moderate to severe idiopathic Parkinson's disease were selected to participate in this study.|After a Screening Period of up to 5 weeks, participants were randomized into 1 of 3 treatment groups (preladenant 2 or 5 mg twice daily or placebo) for 12 weeks. At the end of treatment, participants could choose to enter into an extension trial or return for a follow-up visit 2 weeks later.
739053|NCT01227252||
739054|NCT01227057||
739055|NCT01227044||
739056|NCT01227018|This study opened in December 2010 and ran to April 2013|Seventeen patients consented to this study, 2 were determined ineligible to participate
739057|NCT01227005||
739058|NCT01226979||
739059|NCT01226914|subjects undergoing total or partial thyroidectomy will be consented for this industry-sponsored prospective randomized placebo-controlled double-blind trial.|Subjects will be randomized to placebo or Evicel group based on a computer-generated random number sequence.
739060|NCT01226745||One Subject received 0.15 mg of ONO-4641 instead of placebo in error in the core trial and was subsequently re-randomized during the extension trial and received 0.10 mg of ONO-4641.This subject was not reported in the participant flow for the study.
739061|NCT01226732||
739062|NCT01226719||
739063|NCT01226706||
739064|NCT01226511||This study had 4 periods: Screening period (1-week), acute treatment period (10-week, double-blind period with flexible duloxetine dosing), extension treatment (18-week period, of which 16 weeks were open-label treatment with flexible duloxetine dosing), and a taper period (2 weeks recommended at discontinuation from study any point after Week 2).
739065|NCT01226485||Study completers are participants who received at least one dose of study drug and were evaluated for safety. Part B of the study was not implemented as the estimated half-life was considered long enough for once a day (QD) dosing.
739066|NCT01226472||
739067|NCT01226459||
739068|NCT01226420||
739069|NCT01226121||
739070|NCT01226095||
739071|NCT01226043|Enrollment of patients started on October 26, 2010 and the study was completed on May 7, 2012. Patients were screened in 60 centers in the United States of America, of which 59 centers randomized patients.|A total 623 patients were screened of whom 405 insulin naïve patients were randomized for the crossover phase. The most common reason for non randomization was glycosylated hemoglobin (HbA1c) value out of range at the screening visit as defined per protocol.
739072|NCT01225991||
739073|NCT01225952|This study was an evaluation of three United States Food and Drug Administration (FDA) approved IOLs. A total of 93 participants(186 eyes) were enrolled at one investigative site in the Philippines. First participant was enrolled 7/15/2010 and last participant exited the study 4/28/2011.|186 participant eyes were enrolled in this study 154 participant eyes completed the study. Participants underwent bilateral phacoemulsification and IOL implantation. Participants were randomized to treatment groups prior to surgery.
739074|NCT01225926|Subjects were recruited from one study center located in Russia.|
739075|NCT01225887||
739076|NCT01225835||One hundred seventy patients were screened.
739077|NCT01225822|There were 1973 patients enrolled/randomised in this trial but only 1949 started treatment|
739078|NCT01225731||
739079|NCT01225562||The Participant Flow shows patients randomized. This number is different from patients enrolled in the protocol section which includes patients who were enrolled, but not randomized.
739080|NCT01225549|Patients were enrolled from 4 centres in the AllerGen CIC group in Canada.|Total 27 patients enrolled, 20 (74.1%) patients were randomised to receive a treatment sequence consisting of 4 different treatment in random order. From 20 randomised patients, 18 (90%) patients completed the study and 2 (10%) patients were withdrawn from the study due to consumption of disallowed medication
739081|NCT01225354||
739082|NCT01225341||The study was terminated and the PI/study team no longer has access to study data as it was destroyed. Efforts were exhausted to locate any remaining data, but were unsuccessful. No study data are available to report
739083|NCT01225289||
739084|NCT01225263|Participants were recruited from the greater Boston area. All study visits took place at Beth Israel Deaconess Medical Center (Boston, MA).|Of 89 participants enrolled, 32 were excluded prior to randomization: 8 not interested; 8 lost to follow up; 7 had <4 migraine days/mo; 4 had chronic daily headache; 2 daily opioid use; 1 chronic pain; 1 using a statin; 1 using a medication contraindicated with statin. The remaining 57 participants completed a 12-wk baseline and were randomized.
739085|NCT01225250||
739086|NCT01225211|Participants in each cohort are mutually exclusive. A total of 312 participants were randomized of which one participant did not receive any treatment and a total of 311 participants were treated.|Study included 4 cohorts which were studied in sequential manner. For results reporting, combined placebo arm was reported for Cohort 2 and 3 and results for these 2 cohorts are reported collectively.
739087|NCT01225172||77 participants were enrolled, 59 of whom were treated. Reasons for not entering treatment period included: 3 participants withdrew consent; 11 participants no longer met study criteria and 4 were due to other reasons.
739088|NCT01225159||
739089|NCT01225146||
739090|NCT01225068|Outpatient clinic|Screening visit prior to randomization
739091|NCT01225055||"One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. After consenting the subject did not participate in the study.. This accounts for the 61 in Participant Flow but 60 that were enrolled and started treatment according to their assigned group."
739092|NCT01225029|Patients were recruited at our urban tertiary care center from August 1, 2008 through September 2, 2010. Patients were withdrawn from the study protocol if any respiratory diagnosis other than TTN was made.|73 patients met enrollment criteria, and the parents of 67 eligible neonates agreed to participate. 34 were assigned to standard-of-care fluid management and 33 were assigned to the restricted fluid protocol. 2 patients from the standard fluid group and 1 patient from the restricted fluid group were withdrawn for a non-TTN respiratory diagnosis.
739093|NCT01224925|Four Dental Clinics|Ten subjects were excluded due to a lack of pulpal exposure after the complete removal of caries before assignment to groups
746538|NCT00828516|Recruitment: June 2008 though May 2009. Participants recruited via the Mount Vernon Hospital Lymphoedema Service.|
739094|NCT01224821||Participants (par.) received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases (Ph.): Ph. 1, dosimetric dose; Ph. 2, therapeutic dose. Par. were evaluated until disease progression, they died, or they were on study for 2 years. Par. completing 2 years of study could enter a long-term follow-up study (BEX104526; NCT00240591).
739095|NCT01224782||
739096|NCT01224678||
739097|NCT01224639|Participants took part in the study at 1 investigative site in Colombia from 11 October 2010 to 09 November 2011.|Healthy male and female participants were enrolled in 1 of the 8 treatment groups: Low Dose Subcutaneous:TDV, Low Dose Subcutaneous: Placebo, Low Dose Intradermal:TDV, Low Dose Intradermal:Placebo, High Dose Subcutaneous:TDV, High Dose Subcutaneous:Placebo, High Dose Intradermal:TDV, High Dose Intradermal:Placebo.
739098|NCT01224626|This was a non-interventional retrospective study.|
739099|NCT01224444||1429 patients were consented, of which 269 met inclusion criteria.
739100|NCT01224431||
739101|NCT01224236|Infants were screened by birth weight on admission to the neonatal intensive care unit (NICU). If birth weight criteria were met, infants were followed to see if they met eligibility criteria. If they approached eligibility, parents were approached for consent by the investigator. IRB approved to recruit 4/6/2010. Enrollment completed by 10/2012.|All groups started the study intervention once they had reached goal feedings of 120 cc/kg/day
739102|NCT01224171|Participants with moderately to severely active Crohn's Disease took part in the study at 107 sites worldwide from 24 November 2010 to 12 April 2012. Approximately 75% of participants were to have previously failed tumor necrosis factor alpha (TNFα) antagonist therapy and approximately 25% were to have been naïve to TNFα antagonist therapy.|Participants were randomized 1:1 to receive either 300 mg vedolizumab or placebo. Randomization to treatment assignment was stratified by the presence or absence of previous failure of TNFα antagonist therapy or naïve to TNFα antagonist therapy, concomitant use of oral corticosteroids and concomitant use of immunomodulators.
739103|NCT01224158||
739104|NCT01224145||
739105|NCT01224015||Extension study for patients who participated in study 191622-099
739106|NCT01223963||
739107|NCT01223937||Randomization was stratified by age (<65 years, >= 65 years).
739108|NCT01223703|Potential participants were recruited consecutively from the Heart Failure (HF) outpatient clinic of the University of Brescia. The first patient was enrolled on November 5, 2007, and the last patient completed the study on June 30, 2009.|458 patients were assessed for eligibility. 235 patients were excluded: 251 not meeting inclusion criteria; 74 refused to participate. A total of 133 patients took part in the study.
739109|NCT01223469||
739110|NCT01223404||
739111|NCT01223378|First subject enrolled on 13 Dec 2010, Last subject exited on 20 Dec 2011. This study was conducted at 23 clinical sites. US [15 sites], Bulgaria [3 sites], Poland [3 sites], and Czech Republic [2 sites]).|Subjects who were currently under treatment with an IOP-lowering medication at Visit 1 were required to discontinue the IOP medication during the washout period (minimum of 28 days) between Visit 1 and Visit 3.
739112|NCT01223365|365 patients with chronic pain were screened for enrollment into this study: 25 patients were excluded on the basis of exclusion criteria, 6 withdrew consent, 2 were lost to follow up before the baseline visit, 1 patient did not meet an inclusion criteria, and 1 patient had an opioid violation because of self increasing analgesic medication.|330 enrolled patients came from 61 centers in the US: 166 rolled-over from study 3079, 52 were new opioid-naïve participants and 112 were new opioid-experienced participants. One enrolled patient was withdrawn before taking any study drug.
739113|NCT01223352|Forty-five expert pediatric centers were initiated but only thirty of them enrolled children with pulmonary arterial hypertension (PAH)|
739114|NCT01223235||
739115|NCT01223196|Total of 60 patients were screened and 24 met the eligibility criteria and were randomized.|36 patients did not meet the eligibility criteria and were excluded.
739116|NCT01223183||
739117|NCT01223027||
739118|NCT01223001|Subjects recruited from in-patient and medical clinic population. All subjects suffering from traumatic brain injury and loss of cognitive function.|All subjects performed cognitive testing and assessment for depression. No subjects with seizure disorder or substance abuse issues or previous psychiatric history enrolled. Subjects excluded from the study had previously been prescribed Duloxetine.
739119|NCT01222884||
739120|NCT01222871||One subject enrolled but study was terminated and subject did not start the study.
739121|NCT01222832||
739122|NCT01222715||
739123|NCT01222689||
739124|NCT01222585||
739125|NCT01222572|Due to restrictive eligibility criteria, accrual did not meet expectations.|
739126|NCT01222533||
739127|NCT01222520||
739128|NCT01222507|Subjects were recruited from Washington University ENT and Audiology Clinics, as well as from Washington Univerity Volunteers for Health recruitment enhancement core.|2 subjects failed to meet inclusion/exclusion criteria after signing consent form.
739129|NCT01222494||
739130|NCT01222416|This trial opened to accrual on 10/13/2010 and closed to accrual on 4/14/2015.|No participants were enrolled onto the Fluorodeoxythymidine PET/CT (FLT-PET/CT) arm because this trial closed to accrual early due to slow accrual.
739131|NCT01222403|Subjects were recruited from 24 study sites in Korea.|All subjects were included in the trial.
739132|NCT01222390||
739133|NCT01222299||
739134|NCT01222286|There were 44 patients screened, 14 subjects were not randomized, 12 of whom were screen failures, 30 patients randomized.|All patients enrolled were screened in order to verify the inclusion/exclusion criteria. All patients enrolled (30 patients) were analyzed.
739135|NCT01222273|The CF Foundation patient registry will be queried for patients meeting inclusion/exclusion criteria. A recruitment letter will be sent to these patients. Additionally, patients/parents of patients will be approached regarding study participation by the investigator at routine clinic visits.|
739136|NCT01222260|Between January 2013 and March 2016, 40 patients were enrolled in the study and 31 patients were treated.|
739314|NCT01213043||Subjects entered a Screening Phase (up to 21 days in duration) to determine subject eligibility and for wash-out of prior alpha1-PI augmentation therapy, if applicable, prior to randomization to one of two treatment sequences.
739137|NCT01222247|Participants were recruited from October 2010 to February 2015 at 17 university-based clinical centers. Women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation and a high probability of delivery in the late preterm period were eligible to be enrolled.|
739138|NCT01222234||
739139|NCT01222195|Recruitment Period: 2/22/2009 to 4/20/2010. All patients were registered at The University of Texas M.D. Anderson Cancer Center.|Study terminated due to low accrual, one patient registered on study.
739140|NCT01222117||
739141|NCT01222104||
739142|NCT01222091||
739143|NCT01222078|The study was conducted at one site in France during the period 22 November 2010 to 19 May 2011 and was planned to enroll 8 participants. But only one participant was enrolled and received a single course of study medication. No participants were re-dosed.|
739144|NCT01221948|Subjects recruited at 6 European centers for the study|
739145|NCT01221857||12 patients were enrolled/transplanted; efficacy results were summarized for 11 patients treated with NiCord. 1 patient was transplanted with unmanipulated cord only. Safety results were summarized for all patients.
739146|NCT01221753|7 participants were enrolled between July 2011 and May 2012.|
739147|NCT01221727||
739148|NCT01221623||Includes all subjects who were randomized and received at least 1 dose of study drug; subjects who were randomized but not treated were excluded from the population.
739149|NCT01221597||Includes all subjects who were randomized and received at least 1 dose of study drug; subjects who were randomized but not treated were excluded from the population
739150|NCT01221441||
739151|NCT01221363||"171 participants were consecutively included. However 5 patients withdrew before randomisation, leaving 166 participants to be included and randomised to either the intervention or the control group.
~Reasons for withdrawal were: 4 participants changed their mind because of lack of time, 1 participant reported skin reaction to monitor attachment."
739152|NCT01221350|82 adult patients (>18 years) with history of mild intermittent to moderate asthma according to the Global Initiative for Asthma (GINA) guidelines were screened to participate in the study. Recruitment period: January-September 2011.|55 patients were enrolled in the study prior to randomization and group assignment. From the 82 patients initially screened, 12 patients declined to participate and 15 patients did not meet the inclusion criteria.
739153|NCT01221311||
739154|NCT01221298||
739155|NCT01221285||
739156|NCT01221272|Participants were enrolled in a total of 27 study sites in the United States, Canada, Czech Republic, and Israel. The first participant was screened on 29 September 2010. The last participant observation was on 27 September 2012.|"Number screened: 222; randomized and treated (RAT; Safety Analysis Set): 81
~Efficacy Analysis Set: 61 RAT participants with data for both end-of-period (EOP) scans, completed ≥ 7 consecutive days treatment in each period, took the morning dose before each EOP scan, and had baseline perfusion defect size ≥ 5% as measured by QPS imaging software."
739157|NCT01221233||
739158|NCT01221207||
739159|NCT01221194||
739160|NCT01221181||
739161|NCT01221090||
739162|NCT01220999||
739163|NCT01220973|Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. The study was open to accrual on 02/25/2009 and closed to accrual on 11/13/2012.|We are reporting results on 27 eligible patients. Seven patients were deemed ineligible.
739164|NCT01220869|The participants were recruited among the patients attending the clinics included in the trial|125 participants were screened and 110 participants were enrolled and exposed to degarelix.
739165|NCT01220739||
739166|NCT01220726|The total number of participants recruited and enrolled was 30. A total of 28 completed the study.|
739167|NCT01220687|Women admitted in preterm labor with gestational ages of 25 0/7 to 31 6/7 weeks gestation were approached for prenatal consent. 171 mothers were identified, 95 mothers consented|64 consented mothers or infants met subsequent exclusion criteria. Of those, only 33 were enrolled at time of delivery. Most common exclusion was aging out of gestational age limit, precipitous delivery, or no team available.
739168|NCT01220609||
739169|NCT01220557|The participants were recruited in 23 outpatient study centres, which were located all over Germany. A study centre was defined as a medical practice run by a diabetologist and a diabetes educator or diabetes nurse.|
739170|NCT01220466|One or both eyes of 77 subjects (143 eyes) were treated. This includes a predominance of Caucasian participants and a mean age of 37.2 years.|
739171|NCT01220414||
739172|NCT01220401||
739173|NCT01220297||
739174|NCT01220180||
739175|NCT01220167|Fifty-five healthy adult volunteers were screened for study eligibility between 18 Aug 2008 and 21 Aug 2008 at VIMTA VHS Research Centre in Adyar, Chennai - 600 113, India.|Eighteen of 55 subjects were randomized. Of those not randomized, 29 did not meet eligibility criteria and 6 declined to participate. The 18 eligible participants reported to the study site on 22 Aug 2008, 25 Aug 2008 and 28 Aug 2008 for Period 1, Period 2, & Period 3, respectively.
739176|NCT01220128|Out of the 66 enrolled patients, 6 patients did not receive study product doses and were hence excluded prior to study start.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
739177|NCT01219985||
739178|NCT01219959|The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.|
739179|NCT01219933||
739180|NCT01219881|Patients were approached for consent and were given ample time to decide on participation in the study. This process began in September 2010 and ended in October 2012. All study activity occurred in the hospital or patient clinic.|Enrolled patients were excluded from group assignments if it was discovered after consent an eligibility criteria was not met. After consent patients were further examined for study eligibility and were excluded if they were unable to recieve LMA for the procedure or had a medical condition which was contraindicated with one of the methods.
739181|NCT01219855|Subjects with Stage 3 chronic kidney disease, vitamin D insufficiency and secondary parahyperthyroidism were recruited from 16 sites within the US.|This trial randomized 78 subjects. One subject in the 90 µg treatment arm was lost to follow-up after randomization but before receiving study drug. This subject was excluded from the Intent to Treat population (ITT).
739182|NCT01219777|Patients were enrolled from January to December 2011.|Patients with a histologically or cytologically confirmed EOC with radiographic evidence of advanced disease, consistent with FIGO stage IIIC or IV.
739183|NCT01219738||
739184|NCT01219673|Recruitment Period: March 21, 2013 to June 25, 2013. All recruitment occurred at The University of Texas (UT) MD Anderson Cancer Center.|Due to study design changes and restrictive eligibility criteria, study enrollment was low therefore study terminated early with only one participant enrolled.
739185|NCT01218997||Enrollment was monitored to ensure adequate representation of alcohol-dependent and opioid-dependent patients as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria, and was stratified by alcohol dependence alone versus opioid or mixed substance abuse (ie, alcohol and opioid dependence).
739186|NCT01218984||
739187|NCT01218971||
739188|NCT01218958|Potential subjects were screened up to 14 days before administration of study drug (Study Day 0).|A dynamic randomization was implemented to optimize balancing treatment assignment for 4 prespecified factors: gender, subject's baseline goal of abstinence (ie, yes/no), presence of abstinence prior to randomization, and study site.
739189|NCT01218867||Twenty-four participants were enrolled but one participant was not treated due to a new cancer diagnosis which made the participant ineligible for this protocol.
739190|NCT01218802||
739191|NCT01218672||Ten subjects were determined to be ineligible for the study procedure and were withdrawn before randomization (i.e., study procedure not performed).
739192|NCT01218659||The All Migalastat group was comprised of participants who received migalastat during the randomized treatment period (0-18 mo.) and who received enzyme replacement therapy (ERT) during the randomized treatment period (0-18 mo.) and switched to migalastat during the 12-mo. open-label extension (OLE). 8 participants enrolled but did not randomize.
739193|NCT01218646|The study participants were enrolled from 08 October through 01 December 2010 in 12 clinic centers in the US.|A total of 739 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
739194|NCT01218594|Between May 2009 and January 2012, 50 patients from 5 centers were enrolled onto the study.|Two patients refused treatment after consenting for therapy and were ultimately excluded from the trial before any treatment.
739195|NCT01218516||All screening procedures were completed within 30 days prior to and including the Cycle 1 Day 1 Visit.
739196|NCT01218477||33 participants were enrolled; 27 were treated.
739197|NCT01218438|Participants were enrolled (signed informed consent) at 15 sites.|A total of 86 participants provided informed consent. 9 of these participants did not start Epoch1, of which there were 6 screen failures; 2 were not able to receive their first infusion according to protocol timeline; and 1 withdrew. Therefore, 77 participants started Epoch 1 of the study.
739198|NCT01218399||Participants that contract a viral upper respiratory illness which induces an asthma exacerbation and meets eligibility criteria will be randomized at Day 1 to either Symbicort or Budesonide in a 1:1 randomization. 5 participants were randomly assigned to the Symbicort study arm, and 5 participants were assigned to the Budesonide study arm.
739199|NCT01218308|A total of 5168 subjects have been enrolled in this study. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza vaccine. Unprimed subjects had not received any influenza A (H1N1) 2009 monovalent vaccine or seasonal influenza vaccine.|The duration of the study was approximately 4-8 weeks to complete enrolment, with at least six months extended safety follow-up (ESFU) after first vaccination, and lasted until the end of the influenza like illness (ILI) surveillance period.
739200|NCT01218243|We recruited patients from BPH clinic by newspaper advertisements and notices at clinic site.192 participants entered the study and 92 of them were excluded.It is supposed that patients with IPSS less than 20 would be included.But few mild BPH patients came for the study.The including criteria were changed and patients with IPSS≥8 were included.|Diagnosis and assessment were made by an independent urologist who was uninvolved in the treatment process.Baseline assessments included international prostate symptom score (IPSS), postvoid residual urine (PVR) and maximum urinary flow rate (Qmax).
739201|NCT01218204|The study was conducted at 21 centers in the United States during the period 14 September 2010 to 29 June 2011. There were 6 total participants in Part A, then Part B started with total of 281 participants which flowed through the rest of the phases of the trial. Part B had washout phase and run-In phase followed by treatment phase.|Total 130 participants were randomized and received at least one dose of study drug in the treatment period phase. Part B Run-In excludes those participants randomized to monotherapy arms; that is, these participant counts are only those who were receiving Atorvastatin.
739202|NCT01218126|This study was conducted from 04 November 2010 to 22 December 2011 across 65 centers worldwide. A total of 1000 participants with history of COPD exacerbations were planned to be screened and finally, 600 participants were planned to be randomized.|A total of 886 participants were screened, 282 were screen failures, remaining 604 were randomized to receive the study drug. Out of the randomized 604, 2 participants did not receive the study drug due to error in randomization.
739203|NCT01218113||Out of 191 subjects originally enrolled in the study, only 190 subjects received vaccination and were hence included in the Total Vaccinated Cohort.
739204|NCT01218100||664 patients were randomized to receive double-blind treatment; 661 patients received at least 1 dose of double-blind treatment (Safety Population); and 656 patients had at least 1 postbaseline assessment of trough seated DBP (ITT Population)
739205|NCT01218087||Approximately 800 infants from the 4 participating NICUs were screened; most were excluded for an anticipated length of stay of < 14 days, for medical reasons, and a few parents declined. The total number enrolled out of the approximately 800 screened was 88.
739206|NCT01218048||
739207|NCT01218009||Four hundred fifty-two patients were screened and 331 randomized into the study.
739394|NCT01207934|Subjects were recruited from August 1998 to August 1999. All subjects were recruited via the Volunteer for Health system at Washington University School of Medicine.|
739208|NCT01217957|Participants were enrolled in the study at 10 investigative sites in the United States from 22 November 2010 to data cut-off 08 March 2013.|Participants with a diagnosis of multiple myeloma were enrolled in 1 of 4 dose-escalation cohorts ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2 in combination with lenalidomide, and dexamethasone to establish maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) in Phase 2. 65 participants were enrolled; 15 in phase 1 and 50 in phase 2.
739209|NCT01217944|Out of the 334 patients screened, 277 patients were randomized into the study on a 2:2:1 basis: 106 patients to Group I (treatment with ranibizumab according to visual acuity stabilization), 116 patients to Group II (ranibizumab treatment according to disease activity), and 55 patients to Group III (treatment with vPDT)|
739210|NCT01217892|First participant enrolled: 5 November 2010. Last participant last visit for the 16-week period: 25 August 2011. 520 participants were enrolled, and 400 were randomized in 53 study centers in Europe and South Africa. Subjects with T2DM who showed inadequate glycemic control on metformin therapy alone.|During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Subjects eligible for the study were stratified according to their baseline HbA1c.
739211|NCT01217840||
739212|NCT01217827||
739213|NCT01217814|The study was conducted at 10 centers in United States and Europe. A total of 41 participants were screened between 15 November 2010 and 18 May 2011 of whom 16 participants were randomized and 25 were screen failures. Screen failures were mainly due to exclusion criteria met.|Participants were randomized 2:1:2 (Sarilumab 150 mg : Placebo : Golimumab 50 mg) via a centralized randomization system using an interactive voice response system stratified by region and number of previous anti-tumor necrosis factor-alpha (TNF-α) therapy.
739214|NCT01217801|Healthy adult study participants between 18-45 years (inclusive) of age who were willing to participate in the study by providing written informed consent|
739215|NCT01217749||
739216|NCT01217606||Patients were randomized into a 12-week Initial Treatment phase. Following this phase, patients may have continued into the 9-month Masked Extension on the same treatment assignment.
739217|NCT01217515|Out-patient clinics|one week run-in period
739218|NCT01217476||
739219|NCT01217463||
739220|NCT01217437||
739221|NCT01217411|Recruitment Period: October 1, 2010 to December 21, 2011. All recruitment was done in a medical clinic setting.|Study terminated early due to low accrual and discontinuation of investigational study drug.
739222|NCT01217385|Seven institutions were approved to enroll a total of 60 female breast cancer patients: Enrollment began in June 2011 and completed in June 2013. All institutions activated concurrently, except MD Anderson Cancer Center and Boston University, which joined the study in January and May 2013, respectively.|
739223|NCT01217307||
739224|NCT01217229|A total of 20 participants who met all inclusion and no exclusion criteria were enrolled and received treatment at 6 clinic sites in the United States.|
739225|NCT01217190|The planned sample size was 48. Of the 48 participants enroll in the study, 46 completed the study.|A total of 68 volunteers (52 males and 16 females) were screened for enrollment and a total of 48 volunteers (41 males and 7 females) were subsequently admitted to the study.
739226|NCT01217112||
739227|NCT01217073||
739228|NCT01216943||
739229|NCT01216761|"Please note: it is possible for a single patient to have multiple blood culture sets obtained throughout the study. Therefore, number of blood culture sets will differ from the number of unique patients.
~Also, cross-over assignment occurred at the hospital floor level - not the individual subject level."|
739230|NCT01216748||
739231|NCT01216735||17 Non-smokers were enrolled to provide baseline measures and did not receive any intervention or treatment
739232|NCT01216631||
739233|NCT01216410|December 2008-January 2011, University Medical Center|
739234|NCT01216397||This was an open-label, single-dose, randomised, 2-way crossover trial. Subjects were equally randomised to one of two sequences, and in general terms, AB or BA. Hence, 20 subjects were in group AB and 20 in group BA. All 40 subjects received A and B. The numbers presented in the milestones are overall, which is consistent with the trial report.
739235|NCT01216332||Four subjects (from the high dose group) were excluded from the data analysis , because they were given the second dose of TIV outside the study window period. These four subjects were included in the adverse event reporting.
739236|NCT01216319||
739237|NCT01216241|First subject was enrolled on 14April2011 and last subject enrolled was 01November2012. All subjects were enrolled as inpatients at University of Rochester Medical Center.|All subjects, once consent was obtained were considered enrolled. If they developed a fever they were then randomized to study drug or placebo. If they did not develop neutropenic fever they did not receive study drug or placebo.
739238|NCT01216176||
739239|NCT01216163||
739240|NCT01216072||Patients randomized in a 3:1 ratio to either fingolimod (0.5 mg/day) or MS DMT.
739241|NCT01215981|The original study design included healthy adult volunteers in addition to the HSCT recipients; however, the protocol was modified to exclude the healthy volunteers.|
739242|NCT01215968||
739243|NCT01215955||Protocol had 2 independent studies (Study A, Study B) from which data was analyzed separately and independently: Participants were randomized to 1of the 2 treatment arms (Q1D, Q3D) at the site level. Sites were assigned to a study according to an allocation plan that was pre-specified before initiation of the study.
739244|NCT01215942||Study consisted of a Treatment Period of up to 240 weeks for participants (pts) who enrolled from Studies H9B-MC-BCDO (BCDO) (NCT01202760) and H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for pts who enrolled from Study H9-MC-BCDM (BCDM) (NCT01198002). Discontinued pts were followed in Post-Treatment Follow-Up Period for up to 48 weeks.
739245|NCT01215929||
739246|NCT01215916||Study planned for dose-escalation followed by dose-confirmation phase. Enrollment stopped before anyone entered dose-confirmation phase. Participant (pt) Flow presents pt disposition during dose-escalation & provide reasons for pts who discontinued treatment. All pts who received atleast 1dose of study drug were considered to have completed study.
739395|NCT01207765||
739396|NCT01207726||
739397|NCT01207687||
739398|NCT01207648||
739399|NCT01207596||
739247|NCT01215851|Patients were recruited from outpatient clinics and were admitted to the hospital for the duration of the study at one of 2 centers in Capetown, South Africa. The study was conducted between October 2010 and August 2011. Patients aged 18 and 65 years with newly diagnosed smear-positive pulmonary TB were recruited and randomized centrally.|In the screening period, TB treatment was not provided while baseline sputum was collected/tested. This period was up to 9 days, up to 6 days screening followed by 3 days baseline sputum collection. Hospitalization during this time was left to investigator discretion. 173 patients were screened and 88 patients discontinued before randomization.
739248|NCT01215786||Patients in the AGN-207281 ophthalmic solution arm received AGN-207281 ophthalmic solution 0.1% on Days 1 to 7 and AGN-207281 ophthalmic solution 0.3% on Days 8 to 14.
739249|NCT01215734|This phase X, double-blind study was conducted from September 2011 - April 2012.|Forty-seven patients consented to participate in this study, three were determined ineligible.
739250|NCT01215721|Participants are limited to men undergoing a robot assistered radical prostatectomy at the University of California, Irvine.|Only men who at the 6th or 7th day post-catheter removal are multiple pad users (3 pads or more) will be invited to participate in this trial.
739251|NCT01215695||
739252|NCT01215643||
739253|NCT01215513|The participants were recruited from 9 sites in Korea. All participants had completed the 7-month main study (CS42, NCT01071915) prior to enrollment into this extension study (CS42A). The CS42A study was conducted between 20 September 2010 (FPFV) and 25 April 2012 (LPLV).|
739254|NCT01215435|The trial was conducted at 5 sites in Iran|Subjects were on a stable antidiabetic regimen which includes a minimum of 2 OADs, daily for at least 3 months prior to screening. OAD doses were at least 50 percent of the maximum recommended dose.
739255|NCT01215422|Children were recruited pre-op if their anesthesiologist was participating in the study. Anesthesiologists did 20 baseline intubations with a standard laryngoscope and then were randomized to use the GlideScope(GS)or Karl Storz Direct Coupled Interface (KS) video laryngoscope (VLS) for 20 intubations), followed by the other VLS.|Patients with anticipated difficult airways were excluded.
739256|NCT01215357|Recruitment started Sept 2010 and finished June 2011|See exclusion criteria
739257|NCT01215344|Participants participated in this trial at Vanderbilt-Ingram Cancer Center in Nashville, TN and the Boston Baskin Cancer Group in Memphis, TN. A total of 52 people consented to take part in this study and 15 were ineligible. One participant had disease progression before beginning treatment and wasn't assigned to a treatment arm.|
739258|NCT01215318|Premenopausal women referred for FDG PET/CT examination for staging or follow up of malign disease, were given a modified or unmodified vaginal tampon during the PET/CT examination.|Women with urogenital carcinoma were excluded.
739259|NCT01215292|Healthy men, aged 18-50 years were recruited for this study using newspaper and online advertisement, including flyers posted at the University of Washington, Seattle.|Fifty-two men were screened for the study and 46 met all inclusion criteria. Six subjects withdrew from the study prior to any procedures and 40 were randomized (n=8/group. Exclusion criteria included liver disease or adrenal insufficiency, Body Mass Index > 32, abnormal test results, skin conditions for gel, alcohol/drug abuse etc.
739260|NCT01215279|This study was conducted at 11 centres in 2 countries: 5 in Bulgaria and 6 in Slovakia. The first patient was enrolled on 09 October 2010 and the last patient last visit was on 08 March 2011.|
739261|NCT01215253|1012 patients were recruited from 88 centers in the US and 7 centers in Canada|
739262|NCT01215240||
739263|NCT01215227||
739264|NCT01215188|This trial was conducted in 58 trial centers: 4 in Canada, 8 in Finland, 3 in Israel, 1 in Puerto Rico, 3 in Spain and 39 in the United States.|There were 1152 participants randomized into the study. The 1142 participants included in this study excluded 4 subjects who each received a combination of vaccines and who each had a final disposition of completed and excludes an additional 6 subjects who were randomized but never vaccinated.
739265|NCT01215175|The study was conducted in 15 sites in the US and Finland. Of the 60 randomized adult participants only one participant discontinued from the study. Of the 90 randomized toddler participants only one participant discontinued from the study. A total of 150 participants were screened and all were enrolled.|
739266|NCT01215123|The study duration is January 2010 (first data collected) to July 2012 (last data collected). In this study, medical records of participants evaluated between 2008 and 2012 were reviewed.|
739267|NCT01215110||
739268|NCT01215097|A total of 614 patients were screened in 19 centres in China, Malaysia,and Philippines.A total of 306 patients were randomised in a 1:2 ratio to receive either placebo (101 patients) or linagliptin 5 mg (205 patients) in addition to metformin.|
739269|NCT01215032||
739270|NCT01214980||
739271|NCT01214915||
739272|NCT01214850|Subjects were enrolled from 10 sites in United Kingdom|Total 2968 subjects were enrolled of which 14 subjects were not randomized and were therefore removed from the study (2 subjects withdrew consent and 11 subjects were withdrawn due to inappropriate enrollment and 1 withdrawn due to protocol violation).
739273|NCT01214837|Subjects were enrolled at 3 sites in Canada and 37 sites in United States of America.|All the enrolled subjects were included in the trial.
739274|NCT01214824|Participants with type 1 or type 2 diabetes on Multiple Daily Injection(MDI)of insulin(3 or more injections per day)with an HbA1c of 8% or more for their last two tests were recruited at five sites across the United Kingdom. The target enrolment was 50 subjects, with the aim of completing the study with 40 subjects for statistical analysis.|
739275|NCT01214811||
739276|NCT01214759||
739277|NCT01214720||
739278|NCT01214668||"The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have completed the trial if they experienced progressive disease or an adverse event."
739279|NCT01214655||A participant was considered to have completed the trial if they received at 2 cycles of treatment. Participant Flow Arms represent schedule of dosing, with dose escalation, dose levels and participants who joined the dose level presented as Milestones. Study was based on best Schedule of dosing, not dose levels.
739400|NCT01207583||
739910|NCT01181492|In Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, from November 2008 to April 2010 a total of 176 patients were recruited in this study precedure.|
739911|NCT01181479||
739280|NCT01214642||"Part A is the LY2523355 dose escalation phase and Part B is the LY2523355 dose confirmation phase. The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have completed the trial if they received at 2 cycles of treatment."
739281|NCT01214629||Participants who completed 2 cycles of treatment are considered having completed study.
739282|NCT01214616||
739283|NCT01214603||Study had safety lead-in phase [40 milligrams (mg) LY2090314 administered using 3 treatment schedules]. Each cohort of participants had different schedule. Safety lead-in data determined if expansion phase opened to enrollment. No participant enrolled in expansion phase. Participants who completed 2 cycles of treatment considered study completers.
739284|NCT01214434||
739285|NCT01214395|Recruitment was from the Renal Unit at Sir Charles Gairdner Hospital and was conducted by the nursing staff in that ward. The recruitment period was from 1 July 2010-30 June 2011.|All enrolled patients participated in the trial.
739286|NCT01214356|Eligible if AA and Vitamin D Deficiency|eligibility criteria reviewed
739287|NCT01214330|102 females, age >18, without severe hand arthritis|
739288|NCT01214317||
739289|NCT01214252||
739290|NCT01214239|A total of 608 patients were screened in 19 centres in China, Malaysia,and Philippines.A total of 300 patients were randomised in a 1:2 ratio to receive either placebo (99 patients) or linagliptin 5 mg (201 patients).|Six week (4 weeks of wash-out period, followed by by a two week open-label placebo run-in period) for patients pre-treated with one oral antidiabetic agent in addition to metformin or two weeks placebo run-in for patients pre-treated with metformin monotherapy
739291|NCT01214200||
739292|NCT01214187|The enrollment period opened on 11/29/2011 and was closed on 1/10/2014 when the study reached its enrollment target of 58 subjects. Subjects were enrolled at 8 participating academic medical centers.|Sixty-five subjects were screened, of which 7 subjects were screen failures. Reasons for screen failure included subjects who completed screening changed their mind about participation before visit 2, FEV1/FVC less than 70% predicted, and infection within 1 month before screening. The screening period up to 28 days from date of consent to Visit 2.
739293|NCT01214174||
739294|NCT01214161||
739295|NCT01214109||24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented in the milestone are by overall treatment, A, B, C or D.
739296|NCT01214083|A total of 111 subjects signed consent. Of 111 subjects, 95 subjects were qualified for the trial.|
739297|NCT01214044||
739298|NCT01213966|Patients were recruited at two study centres in Thailand Primary study centre: Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand Sub-centre: Shoklo Malaria Research Unit, Mae Sod, Tak, Thailand The first patient was enrolled on 24 October 2010 and the last patient completed on 25 May 2012.|There was no washout, run-in or transition following enrolment but prior to group assignment.
739299|NCT01213940||
739300|NCT01213836|Patients were recruited at 20 study centres in 5 countries: Austria (1 site), Denmark (1 site), Germany (6 sites), Italy (9 sites) and Spain (3 sites). Recruitment started 2 November 2010 and was completed 29 June 2011. The last patient completed the study on 3 August 2011.|Screening (0 days to 14 days before enrolment), enrolment at Visit 1 (14 days to 3 days prior to randomisation), randomisation at Visit 2 after confirmation of eligibility. 75 patients were screened/enrolled. Of these, 9 were not randomised; 2 patients due to own decision to discontinue and 7 patients due to eligibility criteria not fulfilled.
739301|NCT01213823||
739302|NCT01213706||
739303|NCT01213589|Enrollment of study patients in the Registry began in the medical clinics on 5 December 2006 and was completed on 26 August 2009.|No subject got excluded after enrollment
739304|NCT01213576||
739305|NCT01213524|Participants were recruited from the community using newspaper and other community advertisements.|Participants underwent telephone and in-person screening for eligibility.
739306|NCT01213472|Among 169 subjects screened, 33 were vaccinated and 6 completed the study. Following the NCT00480025 and NCT00796445 studies, which failed to demonstrate clinical efficacy of the MAGE-A3 antigen-specific cancer immunotherapeutic (ASCI), GSK decided to stop the development of ASCI studies and recruitment in ongoing studies.|Accordingly, patients still on treatment in the study, at the time of protocol amendment 3, either continued until last dose or until recurrence, whichever came first, or until patient or investigator decided to stop study treatment. Therefore, the results summary contain limited primary and secondary endpoints results, and are merely descriptive.
739307|NCT01213329|All patients were approached pre-operatively in the transplant clinic at Northwestern Memorial Hospital. Recruitment began on July 28, 2005 and lasted until April 14, 2008.|The first year of the study was specimen collection only. Group assignment (phase 2) was intended to begin after 12months of sample collection and there were not any subjects who continued into phase 2. An additional pair enrolled compared to the number that started this study. This is due to a loss of samples from a processing inconsistency
739308|NCT01213316|The Initial Cohort included participants >=18 years old to receive treatment for 96 weeks. With the amendment, participants in the initial cohort >=50 years old could continue for an additional 48-weeks observation (Prolonged Cohort), and participants >=50 years old were newly enrolled to receive treatment for 48 weeks (Amendment Cohort).|
739309|NCT01213264||
739310|NCT01213251|3 patients exited study prior to randomization.|
739311|NCT01213199|First patient in =25 March 2011, last patient out= 21 Sep 2012|
739312|NCT01213173|Safety Population is divided according to the actual dosage received by the patient, not the randomization. The patient will be high-dose group if the highest dose ever used is above 95mg; otherwise (if the highest dose ever used is equal to or lower than 95 mg) he/she will be low-dose group.|Safety population- patients who received at least 1 dose of investigational product. During initial 1 week run-in period subjects were treated with 47.5mg Betaloc ZOK®. Patients started to take investigational product before randomization therefore, number of subjects in Safety population (274) is greater than number of randomized and treated (251)
739313|NCT01213082||
739437|NCT01205503|Patients were recruited at the University of Kentucky Markey Cancer Center in Lexington, Kentucky, USA between October 2010 and May 2012.|
739315|NCT01212991||Following the independent data monitoring committee's recommendation, a protocol amendment was implemented for double-blind phase to be proceeded to open-label phase, which allowed previously placebo treated participants who had not received commercial enzalutamide the opportunity, to receive open-label access to enzalutamide.
739316|NCT01212952||
739317|NCT01212900||
739318|NCT01212874||
739319|NCT01212770|The study was conducted at 78 study centers in 16 countries.|This study consisted of a 24-week randomized, double-blind, placebo-controlled phase, a 28-week randomized, double-blind active treatment phase and a 4-year open-label safety phase, for an overall study duration of 5 years.
739320|NCT01212757|This study was a multicenter study with 84 sites from the United States, Canada, Europe, Russia, Australia, South Africa and Taiwan.|This study consisted of a 24-week randomized, double-blind, placebo-controlled phase, a 28-week randomized, double-blind active treatment phase and a 4-year open-label safety phase, for an overall study duration of 5 years.
739321|NCT01212744||
739322|NCT01212627||
739323|NCT01212588||
739324|NCT01212484|All patients were recruited at the NYU medical center's Dysautonomia Center.|Patients with FD that complain of severe nausea will be screened.
739325|NCT01212471||
739326|NCT01212445||
739327|NCT01212302|Medical Clinic, 504 patients 2007-2010|post coronary stenting
739328|NCT01212185||
739329|NCT01212172||
739330|NCT01212159||
739331|NCT01212107||A participant was defined as completer of the study after 2 cycles while a participant who discontinued was classified as a discontinuation prior to completing 2 cycles or a discontinuation after 2 cycles. Final disposition for the study is provided.
739332|NCT01212094||One subject received an open label study drug under a compassionate use amendment of the protocol. This subject is not reflected in the data analysis for the primary or secondary outcome measures.
739333|NCT01211873|First patient First Visit : 16 Sept 2010 Last patient Last Visit : 16 Nov 2011 Locations: radiology departments|Any patient who did not fulfill eligibility criteria was not randomized / assigned to a treatment group.
739334|NCT01211769|We comprised the sample through advertisement in newspaper and referral from outpatient services specialized in alcohol dependence treatment. The requirement for their participation was that they were not following any other treatment during the study.|"645 individuals contacted; 325 were excluded after answering the questionnaire by phone. Most of the remaining 320 patients did not meet the inclusion criteria.
~80 patients participated in the study."
739335|NCT01211756||
739336|NCT01211730|Patients were primarily recruited from Liver Transplant Clinic and the inpatient Liver Transplant service|Of 278 patients Consented, 46 died before transplant, 38 did not undergo transplant, 14 were delisted for transplant, and 16 did not enter the study for miscellaneous reasons.
739337|NCT01211665||
739338|NCT01211613|We recruited 112 patients with a new episode of low back pain from the general population of the Greater Pittsburgh Metropolitan region. Recruitment took place during the period of time between November 2010 and April 2013.|197 patients were screened for potential eligibility. We excluded 85 patients for not meeting the inclusion criteria. Of the 40 patients randomized to Standard Medical Care, 3 never showed up for their first visit and 2 were withdrawn by the PI before receiving any treatments; leaving only 35 in that arm.
739339|NCT01211600||
739340|NCT01211535||
739341|NCT01211522||
739342|NCT01211340||
739343|NCT01211288||
739344|NCT01211262||All-patients population and safety population both comprised 84 participants who enrolled in the study and who also received at least one IMCgp100 dose; the all-patients and safety population for Arm 1 was 66 participants and for Arm 2 was 18 participants. Efficacy population was 54 participants in Arm 1 and 15 participants in Arm 2.
739345|NCT01211197||An open label, randomised, three-way crossover study. A washout period of at least 7 days was respected between drug administrations.
739346|NCT01211184|60 patients were recruited from the Department of Orthopedics between May 2008 and September 2009|Information about the study, exclusion criteriae were applied to potential subjects
739347|NCT01211145|This multicenter study was conducted between 7 October 2010 and 31 October 2013.|The study had a 30 day run-in period and up to a 10-week double-blind treatment period. Patients were randomized to receive ZOMIG nasal spray 0.5, 2.5, 5.0 mg, or matching placebo spray to treat a migraine headache. 1653 patients were enrolled, 798 were randomized.
739348|NCT01211106||
739349|NCT01210820|Participants were recruited from an Ophthalmic medical clinic during the period of July 2010 to April 2011.|
739350|NCT01210807||
739351|NCT01210716|The study opened enrollment on Sept 2010 at three hospitals-Yale New Haven Hospital, Mayo Clinic and University of Virginia Health System. A 4th site, BloodCenter of Wisconsin opened enrollment April,2011.|Patients were required to complete two (2) procedures. First procedure was randomized to either Therapeutic plasma exchange on active comparator (AMICUS) or current device (Spectra). The second procedure was completed within approximately 5 weeks on the other device per physician prescription.
739352|NCT01210690|It was planned to enroll 100 patients at approximately 30-40 sites in the European Union.|Overall 101 patients were enrolled. The Participant Flow refers to the Enrolled Set (ES). The ES consisted of patients with a signed Data Consent Form.
739353|NCT01210664||
739354|NCT01210651|Participants were recruited via consecutive sampling of eligible individuals responding to ads approved by the Institutional Review Board of the University of California, San Francisco. Ads were posted in San Francisco libraries, shopping areas, community centers, outpatient clinics, local newspapers, online classifieds & clinical trials websites.|
739355|NCT01210560|Study was conducted at 6 centers in the United States. 25 participants were randomized (12+13) to Group 1 & 2 with 5 & 3 treatment sequences, respectively; received tolvaptan Modified-release [MR] capsules & Immediate-release [IR] tablets in Group 1 & MR in Group 2 over 3 therapy periods (each 7 days) in parallel-group, crossover design|Screening visit, baseline visit, 3 periods - each with 3 treatments in Group 1 & 2 in one of the sequences DAE, DBE, DCE, EAD, EBD / ECD & FGH, HFG / GHF (2 & 4 participants per sequence) respectively; (MR: A&F= 20mg, B&G = 20+20mg, C&H = 60mg, D = 120mg; IR: E = 90+30mg) and 7 Day follow-up. All doses were taken orally once/twice(B&G) daily.
739356|NCT01210495|Total 224 participants were enrolled in the study. Randomized portion enrolled 202 participants in 2 arms (134 in axitinib, 68 in placebo) in 70 centers (13 countries). Non-randomized portion enrolled 22 participants in 2 cohorts (15 in Child-Pugh Class A, 7 in Child-Pugh Class B score 7) according to Child-Pugh score in 13 centers (4 countries).|Participants with Child-Pugh Class A (score 5 or 6) could have been enrolled into either non-randomized or to randomized portion. Participants with Child-Pugh Class B (score 7) were initially enrolled into non-randomized portion but following determination of recommended axitinib starting dose they could have been enrolled in randomized portion.
739357|NCT01210443||Participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks in preceding B1321052 study.
739358|NCT01210352||
739359|NCT01210222|GOG 0229L accrued 35 patients from June 2011 to August 2012. 32 of these patients were eligible.|
739360|NCT01210170||
739361|NCT01210144||A total of 27 participants were enrolled in the study, out of which 2 participants withdrew the consent and 1 participant was excluded since endometrial biopsy was not possible.
739362|NCT01210118|This research took place in two hospitals situated in the area of Attici, Greece namely through the Peripheral General Maternity Hospital 'Helena Venizelos' and the Maternity Unit of the 'Attikon' University Hospital. Recruitment lasted from November 2009- February 2011.|Sixty-six enrolled participants were excluded from the trial before assignment to groups because 36 of them did not meet the inclusion criteria and 30 of them refused to participate.
739363|NCT01210079||
739364|NCT01210001||
739365|NCT01209949|"Dates of recruitment period: First subject was enrolled on October 7, 2010 and the last subject was enrolled on October 12, 2010.
~Types of location: Investigative site was located at a research center."|Wash-out period up to baseline was 30 days for topical and systemic acne treatments with the exception of isotretinoin, which had a wash-out period of 4 months.
739366|NCT01209832||
739367|NCT01209780|The study was conducted in 13 centers across 4 countries: Mexico, Colombia, Panama and Philippines.|Due to GCP non-compliance at the Mexico site, data of 312 subjects (3-8 year olds) enrolled from this site were excluded from the final immunogenicity and safety analysis. The population was analyzed in the enrolled set.
739368|NCT01209767||
739369|NCT01209702||In Part 1, patients were randomized in a 1:1 ratio to placebo or tocilizumab (TCZ) 8 mg/kg. In Part 2, patients were randomized in a 2:1:1 ratio to TCZ 8 mg/kg, TCZ 4 mg/kg, or placebo, respectively. Due to the early stopping of the study and limitations in available data the TCZ dose groups in Part 2 were combined.
739370|NCT01209689|Because of the early termination of the study and the limited and varying duration of treatment, the 4 mg/kg and 8 mg/kg tocilizumab dose groups were combined in the efficacy and safety analyses and reporting.|
739371|NCT01209624|In this prospective non-interventional study, participants did not actively participate in the study but were observed in general clinical practice by office-based ophthalmologists.|
739372|NCT01209598|Protocol Open to Accrual 09/23/2010 Protocol Closed to Accrual 05/27/2014 Primary Completion Date 10/25/2016 Recruitment Location is the medical clinic|
739373|NCT01209520||
739374|NCT01209442||
739375|NCT01209325||
739376|NCT01209286|This study was open to adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia (ALL).|This ongoing study consisted of a core study of up to 33 weeks, efficacy follow-up until 24 months after treatment start and survival follow-up until 5 years after treatment start. Data are reported for the primary analysis conducted when the last participant completed the core study; data cutoff date of 15 October 2012.
739377|NCT01209260|Between January 2011 and November 2012, 72 patients were randomized to 1 of 2 transseptal needle groups.|139 patients were assessed for eligibility; 61 declined to participate, 3 met exclusion criteria, 3 did not enroll for other reasons.
739378|NCT01209234|Recruitment occurred between January 10, 2011 and January 2, 2014, during inpatient admissions in 17 hospitals and 7 nursing homes in Southern California.|
739379|NCT01209195||
739380|NCT01209143||
739381|NCT01209078|The study was planned on 75 male and female participants with Gram-positive acute bacterial skin and skin structure infection (ABSSSI) who were not receiving any antibacterial therapy, aged 18 years or older at eight study centers in the United States from 13 September 2010 to 20 December 2010.|A total of 84 participants were enrolled in the study; of which, 57 participants were randomized in a ratio of 2:1 to receive GSK1322322 1500 milligram (mg) twice a day (BID) and 27 were randomized to receive linezolid 600 mg BID for 10 days.
739382|NCT01208961|The enrollment period started October 2010 and the last subject visit was November 2010. All subjects were qualified at the clinical site and eligibility was determined by the PI (one US clinical site).|This was a 4-way crossover study with a minimum 7-day washout period between each treatment. Subjects were healthy volunteers aged ≥ 18 with a body mass index 25-35 kg/m2 and who were not intolerant to omega-3 products or fish. Subjects were instructed to follow the TLC diet and abstain from omega-3 products or fish for screening and all periods.
739383|NCT01208922|Recruited from November 2010 until January 2016|A total of 835 patients were enrolled and were randomised to one of the 2 treatment groups according to the randomisation plan. All randomised patients received at least one dose of study medication.
739384|NCT01208870|Recruitment in the Western New York area targeted obese and overweight families through pediatric offices and the local community during 2011-2013.|Interested eligible families are oriented, consented, screened, and offered to start the study. There were 94 participants (47 parents and 47 children) eligible to start and 4 participants (2 parents and 2 children) declined before starting the study.
739385|NCT01208415||
739386|NCT01208402|76 subject signed consent. 58 subjects met all inclusion/exclusion criteria and were randomized into the study.|
739387|NCT01208337||
739388|NCT01208233||A total of 181 participants were assigned to study treatment, 178 of which received study treatment.
739389|NCT01208220|Large acute care hospital|
739390|NCT01208207||All Patients Randomized
739391|NCT01208181||
739392|NCT01208103|August 2011 to November 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.|
739393|NCT01208038||
739912|NCT01181349||
739401|NCT01207570|"The subjects were recruited from Heep Hong Society, a non-governmental organization that provides rehabilitation services for children with disabilities.
~The recruitment period was between January 2010 and June 2010."|No significant events.
739402|NCT01207492||
739403|NCT01207466||This reporting group includes all enrolled and dispensed participants. One participant was enrolled but not dispensed due to unacceptable fit. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
739404|NCT01207453||49 patients signed the informed consent document. 8 patients did not meet inclusion criteria and failed screening. 41 patients were randomized and received >= 1 dose of the study drug/placebo. Seven patients stopped participation due to adverse events, and 2 were lost to follow-up. 32 patients completed the study and were analyzed.
739405|NCT01207440|Participants took part in the study at 66 investigative sites in the Australia, Belgium, Canada, France, Germany, Italy, the Netherlands, Republic of Korea, Singapore, Spain, Sweden, the United Kingdom and the United States from 30 September 2010 to 17 January 2019.|Participants were assigned to 1 of 6 cohorts: chronic myeloid leukemia (CML) in chronic (CP), accelerated (AP), or blast phase (BP), or with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who were resistant or intolerant (R-I) to either dasatinib or nilotinib or had (T)hreonine-315-(I)soleucine (T315I) mutation.
739406|NCT01207427||
739407|NCT01207414||500 participants taking antipsychotic drugs: 175 participants in the risperidone cohort, 155 participants in the olanzapine cohort and 170 participants in the aripiprazole cohort were randomized and received study drug in one of two iloperidone treatment arms: gradual switch or immediate switch. 1 randomized participant did not receive study drug.
739408|NCT01207401|July 2010- February 2011, Northwestern Medical Faculty Foundation|
739409|NCT01207388|This study was open to adults with a diagnosis of minimal residual disease (MRD; ≥ 10-³ leukemic cells) -positive B-precursor acute lymphoblastic leukemia (ALL) who were in complete hematologic remission.|
739410|NCT01207219|The recruitment period is from Oct 2010 to Jan 2013 in three outpatient clinics in Hong Kong.|In order to obtain sufficient imaging data for final analysis, a total of 140 patients were recruited and randomized, 16 of them withdrew before starting intervention. Amongst 124 participants, 9 were excluded from final analysis because of changed diagnosis during study period. 95 of 115 participants completed 12-week study.
739411|NCT01207102||
739412|NCT01206816|Aspartate amino transferase (AST) ; Alanine amino transferase (ALT) and Eastern Cooperative Oncology Group (ECOG).|This is a Phase 1, open label, non randomised and dose escalation trial. There was no control group. The Combination of Volasertib and Afatinib to be investigated in two treatment schedules (A & B). In Schedule B the starting doses will be depend on the outcome of the MTD determination from treatment schedule A.
739413|NCT01206777|Patients were enrolled from October 2010 to April 2013|
739414|NCT01206764||
739415|NCT01206738|"For email vs postal study, 880 physicians received email and 880 received postal invitations. 138 and 132 responded respectively. Other recruitment data presented below are for the main trial component, which involved a subset of the 270 (ie. 138+132) responding to the initial invitation.
~See arm descriptions for further explanation."|"Note this study has two parts: 1) an email vs postal invitation study (with 270 enrolled) and 2) a trial involving a subset (172) of those involved in the email vs postal invitation study. The trial enrolled 198 participants in total, with 26 participants not being involved in the email study.
~See arm descriptions for further explanations."
739416|NCT01206660||
739417|NCT01206608||
739418|NCT01206595||
739419|NCT01206582|Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between Mayo 2010 and November 2013.|
739420|NCT01206517||
739421|NCT01206478||
739422|NCT01206465||29 signed a consent form. Two patients never received any study drug: one became ineligible due to rise in bilirubin; another decided against participating.
739423|NCT01206452||
739424|NCT01206439||
739425|NCT01206387||
739426|NCT01206322||Thirty consented subjects, 15 type 2 diabetic and 14 controls completed the protocol. One control was excluded after starting the study. Screened participants that did not start study: 27 were excluded after screening visit, 7 withdrew consent. Enrollment Table list the characteristics of 29 participants who completed the protocol.
739427|NCT01206140||
739428|NCT01206101|"The trial was conducted at 3 sites in 3 countries:
~Canada: 1 site; Switzerland: 1 site; US: 1 site."|All the subjects were on pre-trial insulin at screening.
739429|NCT01206062||
739430|NCT01205828||
739431|NCT01205776|A total of 1905 subjects were randomized (Percutaneous Coronary Intervention (PCI): 948 & Coronary Artery Bypass Graft (CABG) 957) between September 29, 2010 and March 6, 2014. Five hundred and forty-nine (549) subjects were from 56 U.S. sites and 1356 subjects were from 70 international sites,for a total of 126 enrolling sites.|The original EXCEL study consisted of a randomized clinical trial (RCT) (n=2600) & a Universal Registry (n=1000). In February 2014,a decision was made to cap enrollment in the RCT at approximately 1900.The change in scope of the study design was not due to any device or subject safety issues.
739432|NCT01205685|This study was conducted from May 2010 and closed early one year later, May 2011.|12 patients consented, one of which was determined to be ineligible.
739433|NCT01205646||
739434|NCT01205581|Participants were ≥3-21 yrs. at study entry with diagnosis of cancer or HIV. Those with cancer were receiving chemotherapy and/or radiotherapy or had received chemotherapy in the prior 12 weeks. One participant was enrolled but was lost to follow up prior to randomization. 84 participants were randomized between 9/2010 and 10/2011.|Participants excluded if they had: pre-vaccination titer of ≥1:2560, severe hypersensitivity to egg proteins or any component of Fluzone, life-threatening reaction after prior influenza vaccine, history of Guillain-Barre syndrome in subject/subject's family, or unwilling to agree to acceptable birth control for 3 months after each dose.
739435|NCT01205568||Among 73 patients, 331 stenotic vessels were identified. 86 vessels were not eligible and 245 vessels were potentially eligible. 72 vessels were considered successfully treated after low-pressure dilation. 173 met eligibility. 66 vessels were randomized to High Pressure Balloon (HPB) and 107 vessels were randomized to Cutting Balloon (CB).
739436|NCT01205529||
740017|NCT01175369||
739438|NCT01205451||Study LOC114609 (NCT01205451) is the open-label (OL) extension of Study 112958 (a double-blind [DB] study; NCT01153815). Within 3 months of completion of Study 112958, eligible participants were enrolled in Study 114609.
739439|NCT01205438||
739440|NCT01205399|From September 2010 through October 2011 a total of 78 subjects were enrolled at 4 study centers in the United States. The fifth site was terminated because subject data could not be source verified.|
739441|NCT01205269|The study has been performed at four centers in Poland. The first subject entered the study on 10 October 2010 and the last subject completed the study on 17 December 2010. The randomised population consisted of 28 patients, 27 completed the study. All patients were included in the analysis of all variables.|
739442|NCT01205230||
739443|NCT01205165|The study was conducted in participants with chronic hepatitis B and compensated liver disease, at 5 sites in Korea. It was conducted from 01 December 2004 to 28 April 2006.|Of the total 140 participants which were screened only 104 participants were randomized to the study.
739444|NCT01205152|The main criteria for inclusion in Study ENB-002-08 were male and female patients </= 36 months of age, with severe infantile-onset HPP (symptom onset before 6 months of age) who were medically stable (ventilator support was allowed). To enter extension Study ENB-003-08, parent/guardian had to consent and patient had to complete Study ENB-002-08.|
739445|NCT01205126||
739446|NCT01205035||
739447|NCT01204918||
739448|NCT01204905||
739449|NCT01204853||
739450|NCT01204788|Recruitment Period: September 15, 2010 to January 2, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|One participant was not treated and is therefore excluded from the trial.
739451|NCT01204775||Of 26 subjects enrolled, 12 subjects entered the lead in period. Of these 12 subjects, 8 subjects were randomized
739452|NCT01204736||
739453|NCT01204710||A participant was considered to have completed the study if he or she experienced progressive disease (PD) or had died.
739454|NCT01204697||
739455|NCT01204671|A total of 4659 subjects (all aged 18 years and older at the time of their first vaccination as part of this study) were enrolled in this study, of which 4656 were vaccinated. The study vaccine dose was not administrated but subject number was allocated for the other 3 subjects.|Subjects receiving the GSK2321138A and Fluarix™ vaccines were followed in a double-blinded manner throughout the entire study period, from Day 0 to Day 180. Subjects receiving the GSK2604409A vaccine were followed in an open manner until Day 21 only.
739456|NCT01204658|A total of 576 subjects were initially enrolled in the study. Of these, one subject was older than protocol defined age range for the first vaccination, and therefore did not receive any vaccination.|The study duration is approximately 10 to 14 months depending on age at recruitment and age at booster vaccination. 2 Phases in the study: Primary Phase when subjects received a 3-dose of pneumococcal vaccine co-administered with Infanrix hexa™ (Months 0, 1, 2), and Booster Phase when subjects received one dose of the same vaccines (Month 10).
739457|NCT01204398||This was an open-label study with one treatment arm. Whilst 40 patients were enrolled, 39 entered the placebo run-in and 27 were treated. Therefore the treated set (TS) comprises 27 patients and the full analysis set (FAS) comprises 25 patients.
739458|NCT01204294|A total of 618 patients were enrolled in the trial at 43 trial sites, and 37 patients were withdrawn from the trial because of screening failure. 581 patients were entered into the 2-week placebo run-in period, and 7 patients were withdrawn. 574 patients completed the 2-week placebo run-in period and took linagliptin 5 mg or metformin.|
739459|NCT01204255||
739460|NCT01204203|Inclusion criteria included: adult patients (age>18) with unresectable Malignant Pleural Mesothelioma (MPM) who had progressed after one or more prior systemic therapies, had not received prior systemic therapy due to poor performance status (PS), and/or were unwilling to receive systemic chemotherapy.|The primary objective of this study was to evaluate the anti-tumor activity of zoledronic acid (Zometa) in subjects with unresectable, advanced Malignant Pleural Mesothelioma (MPM).
739461|NCT01203956||
739462|NCT01203930|Participants were enrolled at study sites in the United States. The first participant was screened on 28 September 2010. The last study visit occurred on 07 June 2016.|113 participants were screened.
739463|NCT01203917|1060 Caucasian patients with locally advanced or metastatic NSCLC were screened, and 118 patients had activating sensitizing EGFR mutation eligible for the study (EGFR M+). 106 EGFR M+ patients received at least 1 dose of gefitinib. One patient had EGFR mutation not eligible for the study (EGFR M+I) and was started on gefitinib in error.|
739464|NCT01203878|Patients recruited from practices of 3 dermatology clinics. First patient enrolled Nov 2010; last patient completed Dec 2011.|Patients required to complete topical treatment phase prior to randomization to photodynamic therapy or observation. Three subjects discontinued prior to randomization, 2 for adverse events and 1 for withdrawal of consent.
739465|NCT01203852|The first subject was recruited on 8/10/10 and the final patient was recruited on 9/30/2013. Subjects were recruited from family medicine clinics and were identified through providers daily schedules, medical records, and encounter forms.|Healthy volunteers with mild to moderate primary hypertension between the ages of 18-70 were eligible for the study. Subjects were washed-out from their hypertension medication prior to beginning study protocol. Participants with elevated systolic blood pressure greater than 180 mmHg after wash-out were excluded from the study.
739466|NCT01203826|The main criteria for inclusion in Study ENB-006-09 were patients ages 5 to 12 years inclusive, with open growth plates at time of study entry and a documented diagnosis of HPP. To enter the extension, Study ENB-008-10, patients had to successfully complete Study ENB-006-09 and provide consent.|
739467|NCT01203787||
739468|NCT01203644||
739469|NCT01203319||
739470|NCT01203189||
739471|NCT01203098||
739472|NCT01203072||
739473|NCT01203046|The data was collected between December 2010 and November 2011 including patients with penetrating abdominal trauma admitted at Dr. Miguel Perez Carreño Hospital emergency room.|We were behind schedule to start the trial waiting for institutional approve.
739474|NCT01202994||
739475|NCT01202955|Participants were recruited using mass media advertising from July 2008 to April 2009.|Each participant's catechol-o-methyl transferase (COMT) genotype was determined prior to medication assignment.
739476|NCT01202903|Of the 616 patients randomized 7 (2 omalizumab and 5 placebo) did not receive drug and were excluded from the Full Analysis Set (FAS) and Safety Set.|One additional patient did not receive study drug for greater than 60 days and was also removed from the FAS. 4 patients initially randomized to the placebo group received omalizumab at one or more administration and were considered part of the omalizumab group for the Safety Set.
739477|NCT01202877|Recruitment period: March 2, 2011 to October 01, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.|There were 57 participants for enrollment, one participant was a screen failure and two withdrew consent without receiving the study drug treatment and are therefore excluded from the study.
739478|NCT01202773||Study had a treatment period (Weeks 0-24) and a post-treatment follow-up period (24-48 weeks in length). All participants were assessed for nonresponse at Week 16 with non-responders (NR) defined as participants with <20% improvement from baseline in both tender and swollen joint counts.
739479|NCT01202760||
739480|NCT01202747|A total of 50 subjects (100 eyes) were enrolled at 3 investigational sites between 10/03/2010 and 11/15/2010.|
739481|NCT01202721||
739482|NCT01202656|All patients presenting for embryos transfer between October 3, 2010, and January 1, 2013, were offered participation in the trial. A total of 419 eligible patients were offered participation: Only 129 patients consented to participate in this study,(12 addtional patient participated in the thin endometrium study) and 278 declined|The principal reasons for refusal to participate were ''lack of interest'' and technical difficulties in presenting in timely fashion for the treatment to the center. Women with renal disease, sickle cell disease, or a history of malignancy were considered ineligible. No consenting patient was excluded from participation for medical reasons.
739483|NCT01202643|All patients presenting for embryos transfer between October 3, 2010, and January 1, 2013, were offered participation in the trial. A total of 419 eligible patients were offered participation: Only 12 patients consented to participate in this study,(129 addtional patient participated in the NCT01202656 study) and 278 declined.|The principal reasons for refusal to participate were ''lack of interest'' and technical difficulties in presenting in timely fashion for the treatment to the center. Women with renal disease, sickle cell disease, or a history of malignancy were considered ineligible. No consenting patient was excluded from participation for medical reasons.
739484|NCT01202591|First patient was enrolled on 8 Dec 2010 and Last patient last visit was on 21 Oct 2014. Recruitment was slow, leading to concerns about the feasibility of completing enrolment. Moreover, the limited evidence of clinical activity of AZD4547 monotherapy in FGFR gastric cancer and NSCLC has resulted in a business decision to terminate enrolment.|"Part A: 38 patients enrolled, 31 patients received AZD4547+exemestane; 7 patients did not receive (5 patients were not eligible, 1 patient due to patient decision, 1 patient due to Other) Part B: 89 patients enrolled; 80 were not eligible, 9 patients received the treatment"
739485|NCT01202578|Eligible subjects presenting to the clinical study site for whom tympanostomy tube insertion was recommended were offered the opportunity to participate in the study by study investigators.|
739486|NCT01202565|The study was conducted in Slovenia, Hungary, Slovakia, Romania, Israel, Czech Republic, Ukraine and Estonia.|Reasons for study discontinuation were not systematically collected. Five participants were lost to follow-up after the Baseline visit and had no entries regarding treatment with adalimumab and were excluded from the full analysis set (FAS) which finally comprises 501 participants.
739487|NCT01202409||
739488|NCT01202279|Recruitment took place October 2009 through April 2010. Advertising was not allowed for this study. Patients were seen by a Health Care Provider(HCP) and must have been seeking treatment for symptoms diagnostic for an acute upper respiratory tract infection.|
739489|NCT01202253||
739490|NCT01202227|Japanese patients with central neuropathic pain after spinal cord injury who had completed the preceding A0081107 study (NCT00407745) were eligible for this study, and Japanese patients with pain after cerebral stroke or with multiple sclerosis pain were newly recruited.|Participants who had joined A0081107 study (NCT00407745) were treated with pregabalin or placebo for 16 weeks and underwent tapering phase prior to this study.
739491|NCT01202188||There was a 14 day run-in period prior to randomization.
739492|NCT01202175|Study results are being entered according to a publication that was published before PI passed away. According to the publication; two participants dropped out because of flu-like symptoms, 2 were lost to follow-up, and 1 dropped out of the study after the initial visit but never took the medication. It is unknown what arm they were in.|
739493|NCT01202162|85 Subjects were recruited and randomized and 80 completed the study. Subjects were consecutively enrolled from December 2010 through February 2012.|
739494|NCT01202110||
739495|NCT01202071|This study was recruited at 1 center in Japan during the period of 14-Sep-2010 to 2-Dec-2010.|
739496|NCT01201967||
739497|NCT01201915||
739498|NCT01201811|The study was conducted at nine investigational sites within Taiwan. The purpose of the current study was to evaluate the efficacy, safety, and steady-state Pharmacokinetic (PK) profile of subcutaneous (SC) azacitidine given at a dose of 75 mg/m^2/day for 7 days in Taiwanese participants with higher-risk Myelodysplastic Syndrome (MDS).|
739499|NCT01201798|Subjects were recruited from 21 US study sites.|This reporting group includes all randomized subjects: 110. One subject was enrolled but discontinued prior to receiving study medication, with treatment randomization unknown.
739500|NCT01201785|From January 2009 to April 2010 patients were recruited at the outpatient clinic of the Division of Cardiology at Shands Jacksonville Hospital.|A total of 82 patients were screened; 48 were eligible and 36 agreed to provide their written consent. Of these, 16 did not complete all 5 treatment regimens. Therefore, a total of 20 completed all the study phases and used for analysis.
739501|NCT01201772|Patients recuited at outpatient cardiology clinics|Seventy-seven patients on maintenance prasugrel therapy were screened. Of these, 11 patients refused to participate in the study and one patient was excluded due to a positive pregnancy test. Thus, a total of 65 patients were randomized.
739502|NCT01201759|Participants underwent randomization to either 1 month of Salsalate ( 4.0 grams daily in split doses) or placebo.|An untreated wash-in (1 month) preceded treatment (1 month).A 1 month wash-out between cross-over.
739503|NCT01201629|From 2010 to 12/2015 at the OKC VA Med Center as in-patient|No significant events or enrolled participants were excluded.
739504|NCT01201486||
739505|NCT01201356|This was an open-label, multi-center, single treatment arm design allowing patients participating in the fingolimod MS clinical development program to enroll in order to collect additional long-term safety, tolerability, efficacy, and health outcomes data.|This study had two parts: Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data until all Part 1 end of study (EOS) visits and last follow-up visit; Part 2, collecting limited safety and tolerability data, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.
739506|NCT01201343||
739507|NCT01201317|The first participant was enrolled on 20th September 2010 and the last participant completed on 6th June 2011. A total of 20 centres in United States (US) and Canada randomised 134 participants.|The study had an enrolment phase of up to 35 days (including wash-out and baseline periods), a 28-day treatment phase, and a follow-up phase of 7-14 days. Participants were randomly assigned to blinded treatment in a 1:1:1 ratio either to AZD2423 20 mg, AZD2423 150 mg or placebo.
739508|NCT01201265||
739509|NCT01201057||No relevant events.
739510|NCT01200992||
739511|NCT01200875||
739512|NCT01200862|14 participants enrolled in Part 1 and 15 participants enrolled in part 2.|
739513|NCT01200810|A total of 19 patients were enrolled from a comprehensive cancer center in central New Jersey from August 2010 through November 2011.|During the induction phase, if subjects do not have a decline in PSA ≥ 50%, they are taken off study. Subjects who have a PSA decline ≥ 50% are randomized to Arm I or Arm II.
739514|NCT01200797|The study opened to accrual in July 2010, with participants enrolled from 11/1/2010 through 8/30/2012. Five Southeast Phase 2 Consortium (SEP2C) cancer center sites participated in this study.|Twenty-two patients consented to this study. Three were not eligible to receive treatment.
739515|NCT01200758||Screening/baseline tests were performed within 28 days before randomization. Randomization was centralized in a 1:1 fashion using the Pocock and Simon dynamic randomization algorithm. The study was conducted in 2 stages: Stage I & II. All participants irrespective of the treatment period completion commenced follow-up period in both Stage I and II.
739516|NCT01200602|One patient was accrued between March 2, 2011 and January 10, 2012. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|
739517|NCT01200589||Participants were randomized in a 1:1 ratio to Ofatumumab or Rituximab.
739518|NCT01200524|The first participant was enrolled on 6th October 2010 and the last participant completed on 3rd April 2012. A total of 36 centres in France, Denmark, Poland, Russia, UK, Sweden and Bulgaria randomised 133 participants.|The study had an enrolment phase of up to 30 days (including wash-out period), a 28-day treatment phase, and a follow-up phase of 7-14 days. Participants were randomly assigned to blinded treatment in a 1:1:1 ratio either to AZD2423 20 mg, AZD2423 150 mg or placebo.
739519|NCT01200511|Subjects were recruited from 5 investigational sites located in Germany (2), Venezuela (2), and Spain (1).|This reporting population includes all enrolled subjects.
739520|NCT01200498|Recruitment Period: 11/9/2010 through 11/12/2012. All participants recruited at The University of Texas MD Anderson Cancer Center.|Of the twenty-three participants enrolled, one participant withdrew consent and was excluded before starting the study.
739521|NCT01200485|Recruitment Period: April 25, 2011 to September 10, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|Cycle 2 is the study cycle; of the 55 participants enrolled on study, 52 were treated in cycle 1 (rasburicase alone), and only 46 were randomized onto the two arms in the study cycle (cycle 2, Arm A: Rasburicase; Arm B: Allopurinol).
739522|NCT01200433||
739523|NCT01200394||
739524|NCT01200368||
739525|NCT01200355|Protocol Open to Accrual 09/09/2010 Protocol Closed to Accrual 04/20/2016 Primary Completion Date 04/20/2016 Recruitment Location is the medical clinic|
739526|NCT01200342|Recruitment Period: December 6, 2010 to November 05, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.|Study was terminated early due to decision by drug sponsor to no longer manufacture investigational drug.
739527|NCT01200329|Patients enrolled at MD Anderson clinic starting on June 16, 2011.|
739528|NCT01200290||This study consisted of a 24-week treatment period (Weeks 0-24) and a follow-up period (up to Week 76). Participants who discontinued study drug administration were placed into the post-treatment follow-up period.
739529|NCT01200238|The first and last participants registered to cohort A on September 17, 2010 and June 6, 2011 and to cohort B on December 27, 2011 and May 12, 2014.|
739530|NCT01200160||
739531|NCT01200069|recruited following assigned schedule date and time for first ECT treatment, Procedure took place in Medical Special procedure unit (same day service)|
739532|NCT01200030||
739533|NCT01199965||All smoking and non-smoking subjects received both MAP0004 and Intravenous (IV) Dihydroergotamine (DHE).
739534|NCT01199952|"subjects were recruited at the county hospital abortion clinic from 3/21/2011 to 5/25/2012.
~Follow up phone calls were conducted 6 week and 6 months after enrollment, with the final follow-up completed 1/2/2013."|
739535|NCT01199939|The study was conducted between 29 March 2010 and 5 October 2012 and recruited patients from US (17 sites) and Puerto Rico (1 site).|54 participants were treated with Etravirine and Darunavir/ritonavir in this study.
739536|NCT01199926|Recruitment Start Sept 2008 Recruitment at Purdue University|Following participant recruitment, baseline testing was completed prior to enrollment, study initiation and group assignment.
739537|NCT01199861||Participants were randomized in a 2:1 ratio to fingolimod 0.5 mg once daily or matching placebo.
739538|NCT01199822||There were 3 cohorts and enrollment into the next cohort did not occur until all participants in the previous cohort completed 1 cycle of treatment or discontinued due to dose-limiting toxicity (DLT). Participants who completed Cycle 1 or had DLT during Cycle 1 are considered having completed study.
739539|NCT01199744|This Sentinel Site Monitoring Program collected the patient background and safety data of Relenza administered in the Japanese population per the requirements of the Japanese Ministry of Health, Labour and Welfare (MHLW).|
739646|NCT01194440|From February 2011 to January 2013, 59 women signed consent, met eligibility criteria, and received study intervention on this clinical trial at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins.|3 participants were screen failures and 1 participant withdrew consent prior to assignment to treatment.
739540|NCT01199731|A total of 17 investigational sites enrolled participants in this multicenter study: 1 center in Romania and 16 in the United States. The study was initiated on 04 October 2010 and was terminated on 01 April 2011 with last participant visit on 19 July 2011.|Enrollment in this study was terminated prematurely due to a safety finding (convulsions) in 5/20 participants who received GSK2248761. At time of enrollment termination, 30/150 planned participants were enrolled.
739541|NCT01199705|This multicenter study enrolled subjects at nine of the participating study centers in Japan.|Screening took place 3 to 4 weeks prior to or at the first intravenous immunoglobulin (IVIG) infusion in the IVIG period of the study.
739542|NCT01199601|Women in active labor able to provide consent recruited by random number designation at four Kabul public maternity hospitals following admission. Recruitment occurred from June 2008 through January 2009.|
739543|NCT01199575||
739544|NCT01199471||
739545|NCT01199380||
739546|NCT01199263||
739547|NCT01199237|At one U.S. clinical site, patients scheduled to undergo surgery requiring general anesthesia lasting approximately 1.5 - 3.0 hours requiring tracheal intubation and paralysis during surgery were invited to participate|Participation of the first 26 enrollees was considered a pilot to determine the feasibility of measuring the primary outcome at T1+5 minutes. The majority of participants were alert, and no meaningful analyses could be made. The study was modified to assess the primary outcome at T1 + 2 minutes, and 81 additional participants were recruited.
739548|NCT01199198|Recruitment Period: May 5, 2011 to July 13, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 52 participants enrolled, only 48 patients were randomized to participate in the study. Two participants were not randomized due to contra indicated medication and another two were not randomized due to exclusion criteria. The study was stopped for superiority.
739549|NCT01199146||
739550|NCT01199068|A total of 15 participants who met all inclusion and no exclusion criteria were enrolled in the study. Fourteen participants received treatment.|This study consisted of 2 parts: initial portion and additional portion. In the initial portion, participants received CS-7017 (starting dose 0.25 mg BID ascending to 0.50 mg BID) in combination with erlotinib. In the additional portion, participants received CS-7017 0.50 mg BID in combination with erlotinib.
739551|NCT01199055|A total of 18 participants were screened for eligibility. Of the 18 participants who were screened, 16 participants who met all inclusion criteria and no exclusion criteria were enrolled from 17 March 2010 to 15 April 2011 at 1 site in South Korea. All 16 participants received treatment.|This dose-escalating study included an initial and additional portion. Participants received CS-7017 combination treatment with carboplatin & paclitaxel (starting dose 0.25 mg twice daily [BID] in the initial portion). In the additional portion, the CS-7017 dose was determined (0.50 mg BID) based on the initial portion.
739552|NCT01199042|Twenty-nine patients were enrolled between September 2010 and February 2013. Two participants did not meet) criteria after centralized scoring of diagnostic and CPAP polysomnograms (PSGs) and were excluded from analysis. Twenty-seven participants (five women) completed 3 nights in-laboratory attended PSG, and 26 completed 3 months of follow-up.|
739553|NCT01199016||
739554|NCT01198977||
739555|NCT01198873|"Recruitment initiated in September 2010 was discontinued in September, 2011 due to significantly lower than planned enrollment with no feasibility to complete the trial within reasonable, meaningful timelines.
~At that time 57 sites in US and Canada had screened at least one patient."|"After signature of the informed consent and after eligibility was confirmed, group assignment was made at site in a 1:1 ratio using a treatment code list generated centrally by Sanofi. Participants were considered as randomized as soon as the assignment was made.
~A total of 76 participants were randomized at 39 sites."
739556|NCT01198795|Patient recruitment occurred at 16 studies sites located in the US from October of 2010 to August of 2012.|All patients completed a 1-week no-drug screening period before beginning treatment with study drug.
739557|NCT01198769||
739558|NCT01198756|A total of 3109 subjects were enrolled, out of which solely 3094 subjects were vaccinated who constituted the analysed population in this study.|Unprimed Subjects - subjects aged 6 months to 8 years with no H1N1 vaccine or H1N1 infection in the last season, or with no seasonal influenza vaccine in the past or who had received only 1 dose for the first time in the last season - received a 2-dose vaccination course. Primed Subjects - all other subjects - received a 1-dose vaccination course.
739559|NCT01198691||
739560|NCT01198600|Participants were recruited from one Canadian research center.|Baseline characteristics are presented for all enrolled participants: 78. The participant flow chart includes all enrolled and dispensed participants: 72. Six participants were enrolled but not dispensed.
739561|NCT01198587|Patient were screened from the emergency department to identify patient meeting study enrollment criteria|
739562|NCT01198574|Screening for the study subjects was conducted in July, 2010 among the adolescent schoolgirls in Nyaung Done Township, Irrawaddy Division. It included assessment of Hb status using the Coulter Counter. Information on the general characteristics and menarche status of the girls are obtained.|Deworming with 400 mg Albendazole was done one week before the baseline data collection.
739563|NCT01198548||
739564|NCT01198509|Dates of recruitment period: January 2010 - August 2012 Locations: Medical clinics and faculty practice offices|
739565|NCT01198470||
739566|NCT01198366||
739567|NCT01198327|66 retinal vein occlusion patients from the HORIZON study(NCT01198327)were enrolled from 7 sites for long term follow up. The sites were: Wilmer Eye Institute, Ophthalmic Consultants of Boston, Retina Consultants of New Jersey, Retina Consultants Macula Group,Retina Consultants of Houston, Southeast Retina and Retina Vitreous Associates|
739568|NCT01198275||
739569|NCT01198158||
739570|NCT01198145||
739571|NCT01198132||A total of 129 subjects were randomized. Out of which 126 subjects treated in the study and 90 subjects completed the study.
739572|NCT01198028|Participants were recruited in head and neck clinic and from referrals from outside clinics between April 2011 and June 2014 at MD Anderson Cancer Center.|A total of 42 participants enrolled,39 participants started 1 withdrew, 1 came off study the same day consented and 1 participant was ineligible.
739810|NCT01186809|A total of 74 patients were enrolled in the study from July 2009 to September 2016|
739811|NCT01186796||
739573|NCT01198002||Study had a blinded Treatment Period 1 (Weeks 0-52), a non-blinded Treatment Period 2 (Weeks 52-100) and a post-treatment follow-up (24-48 weeks in length). All participants were assessed for nonresponse at Week 16 with non-responders (NR) defined as participants with <20% improvement from baseline in both tender and swollen joint counts.
739574|NCT01197911|A total of 38 participants with normal hepatic function, or with mild or moderate hepatic impairment were enrolled from 30 September 2010 to 05 August 2011 at 2 study sites in the U. S.|
739575|NCT01197898|Patients with Type I or II diabetes mellitus and a non-healing foot ulcer including postamputation wounds and wounds on the dorsum of the foot.|
739576|NCT01197833||
739577|NCT01197794|1144 participants were randomized. The first participant was enrolled on 19 October 2010 and the last participant completed the study on 16 February 2012.|Participants were screened for a period of 31 days out of which 17 days for enrollment and 2 weeks for run-in period.
739578|NCT01197755|A total of 638 patients were enrolled: 105, 108 & 110 were randomised to Groups A, B & C respectively (105, 108 & 109 received at least 1 dose of investigational product).|A total of 315 patients failed screening.
739579|NCT01197612||"Of 23 participants who consented, data is only available for 20. Two never had surgery, and so were not assigned at all."
739580|NCT01197573|DCD donors from 2010 to 2013.|
739581|NCT01197560|Screening and enrollment occurred at 43 sites, including 10 in the United States, 9 in France, 7 in the United Kingdom; 4 in Spain, 4 in Italy, 3 each in Austria and Australia, 2 in the Czech Republic, and 1 in Sweden.|Participants were stratified into Germinal center B-cell (GCB) or non-GCB subtypes and randomized 1:1 to receive lenalidomide or investigator's choice treatment (one of the single-agent reference therapies [gemcitabine, rituximab, etoposide, or oxaliplatin)
739582|NCT01197547||
739583|NCT01197534|A total of 1632 patients were enrolled: 308, 300 & 305 were randomised to Groups A, B & C, respectively (308, 298 & 302 received at least 1 dose of investigational product).|A total of 719 patients failed screening.
739584|NCT01197521|A total of 1475 patients were enrolled: 311, 306 & 306 were randomised to Groups A, B & C, respectively (310, 304 & 304 received at least 1 dose of IP).|A total of 552 patients failed screening.
739585|NCT01197508|This multicenter study was conducted in Europe, South Africa, and Latin America between 1 September 2010 and 30 January 2012.|The study had an up to 21-day screening/washout period, and an 8-week prospective open-label antidepressant treatment (ADT) period to identify the target patient population of inadequate responders to ADT (<50% reduction in HAMD-17 total score during the prospective open-label ADT period, a HAMD-17 total score of ≥16 and a CGI-S score ≥4).
739586|NCT01197495||The modified intent-to-treat (mITT) population is presented and includes all treated subjects.
739587|NCT01197456||
739588|NCT01197417||
739589|NCT01197378|Initially, only patients who completed the previous Phase III Study RP103-03 (NCT01000961) were enrolled in this extension study. As of 27 September 2011, enrollment was opened up to additional participants, including children who were less than 6 years of age and kidney transplant subjects who qualified based on the inclusion/exclusion criteria.|
739590|NCT01197326|A total of 439 beds in 12 general wards in 10 hospital from five countries inthe USA, Europe and Australia.|
739591|NCT01197300|This study was conducted in 10 centers in 6 countries: Australia (1), Canada (4), Hungary (1), United Kingdom (1), Russian Federation (2), and South Africa (1).|This was an open label extension to the Core study CZOL446H2337 (NCT00799266), where all patients received zoledronic acid. However, the study groups from the Core study were used to compare the patient populations within this extension phase, who received the same treatment under each particular group.
739592|NCT01196988|Subjects were differentiated according to their priming status. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza in the last season or had received at least 1 dose prior to last season. Unprimed subjects had not.|3015 subjects out of the 3027 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria. The treatment was stratified by age strata: 3-8 and 9-17 years. Another arm evaluates the GSK2321138A vaccine for children aged 6-17 and 18-35 months.
739593|NCT01196975|1703 of the 1707 subjects enrolled in the study were actually administered vaccination. The other 4 subjects were not vaccinated due to failing at meeting protocol specific criteria.|For some outcome measures, the subjects receiving the GSK2282512A vaccine, from Lot 1, 2 or 3, were pooled into one larger pooled group, the GSK2282512A Group, and/or groups were stratified into the 4 age categories: 18 to 60 years (18-60Y), 61 years and older (≥61Y), 18 to 64 years (18-64Y), and 65 years and older (≥ 65Y).
739594|NCT01196936|Participants were screened for eligibility at each participating institution.However, after central review of mammograms, 11 participants were ineligible for the study (mammographic density <25%) and 1 participant was randomized but withdrew before taking the study drug. These 12 participants were excluded from the analysis.|
739595|NCT01196923||
739596|NCT01196871||The total number of unique participants in this study was 20: 3 from Stage 1 were re-enrolled and newly identified in Stage 2. Of those, 1 initially received 0.5 milligrams (mg)/kilogram (kg) agalsidase beta; after resolution of an agalsidase beta shortage, their dose was increased to 1.0 mg/kg; all remaining visits were completed at this dose.
739597|NCT01196819||
739598|NCT01196793||
739599|NCT01196741||
739600|NCT01196533|during 2009|
739601|NCT01196442|Subjects were enrolled from 08/30/2010 through 06/11/2012 at a medical clinical|No pre-assignment criteria
739602|NCT01196429|The study was activated on 8/30/2010 and closed to accrual on 1/6/2014.|Additional details about the interventions administered were not included because these are groups (not arms).
739603|NCT01196416||
739604|NCT01196377|We recruited 16 patients ages 5 to 17 years for this double blind randomized trial.|
739605|NCT01196117|Participants were recruited from sleep clinic patients scheduled for polysomnography.|Participants without prior treatment of obstructive sleep apnea (OSA) or overt airway structural pathology that would interfere with continuous positive airway pressure (CPAP) were recruited.
739812|NCT01186770||A total of 804 participants met inclusion/exclusion criteria and randomized in 1:1:1:1 ratio to either MNTX 150 mg, MNTX 300 mg, MNTX 450 mg, or placebo treatment groups.
739813|NCT01186744||
739606|NCT01196104|The FIrst Patient First Visit (FPFV) was September 21, 2010, and Last Patient Last Visit (LPLV) was August 25, 2011. Trial conducted in US. The study was terminated before completion of full enrollment for business reasons. Subjects already enrolled were allowed to complete the study to assess the safety of the titration algorithms.|"After a 1 week to 5 week run-in period, subjects were randomized to receive either TI Inhalation Powder in combination with insulin glargine, or insulin aspart in combination with insulin glargine.
~105 Screened/46 Eligible. 39 subjects were randomized; 59 screen failures and 7 were screened but not randomized."
739607|NCT01196091||Intent to Treat population (ITT) is all randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.
739608|NCT01196078||
739609|NCT01196052||
739610|NCT01196026|"Primed subjects =subjects who had been previously vaccinated with a seasonal influenza vaccine whereas unprimed subjects had not.
~children ≥ 9 years + primed children < 9 years=1 dose of Fluarix
~unprimed children < 9 years=2 doses of Fluarix. To complete the vaccination schedule, a 2nd dose of Havrix vaccine was given outside the study setting"|162 subjects were enrolled in the study but only 154 subjects were vaccinated. The remaining 8 subjects gave their consent withdrawal and were not included in the study.Enrollment was stratified according to the age at first Pandemrix vaccination: 6-11 months, 12-35 months, 3-9 years. Also, subjects were grouped from 3-5 and from 6-9 years.
739611|NCT01195948||
739612|NCT01195922|Subjects were recruited from the National Institute of Health (NIH) as well as the Medical University of South Carolina (MUSC). Recruitment began 5/16/2011 with a total of 37 subjects consented; 34 at MUSC and 3 and NIH. Of the 37 consented, 16 subjects received study intervention and completed the study.|37 participants signed consent, 16 participants received study drug.
739613|NCT01195883||
739614|NCT01195844||
739615|NCT01195831|The study period was 17 September 2010 (date of the first enrolment) to 01 March 2011 (date of last patient out)|
739616|NCT01195779|Since this study was prematurely terminated (not because of safety issues or lack of immunogenicity but for logistic reasons) only 4 of 1120 planned subjects were enrolled.|
739617|NCT01195701||
739618|NCT01195675||
739619|NCT01195662|Recruitment: 29-Oct-2010 to 04-Oct-2012. Original study had 3 arms but 5 mg dapagliflozin arm was discontinued with Protocol Amendment 8 (implemented 01-Nov-2011) because totality of data in development program showed that once daily 10-mg dapagliflozin provides optimal efficacy with safety and tolerance. Study continued to enroll with 2 arms.|2245 enrolled. 1213 completed enrollment;1032 not completed:1 adverse event (AE), 65 withdrew consent (WC), 7 lost to follow up (LTF), 2 administrative (admin), 934 criteria not met, 2 non-compliant, 21 other. Lead-In: 588 randomized; 625 not randomized: 6 AE, 69 WC, 13 LTF, 8 admin, 2 at request, 497 criteria not met, 11 non-compliant, 19 other.
739620|NCT01195636||
739621|NCT01195623||
739622|NCT01195597|Healthy smokers 18-60 years old, smoking ≥ 15 factorymade cigarettes per day (cig/day) for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days were recruited, Italy. None of the participants reported a history of alcohol and drug use, major depression or other psychiatric conditions.|
739623|NCT01195584|All patients fulfilling in- and exclusion criteria were enrolled into the retrospecitve study. All consecutive 72 patients who signed the patient informed consent were included. Patients were stratified in three groups according to their body mass index (BMI) established by WHO. Enrollment period from January 2009 - August 2010|
739624|NCT01195545||
739625|NCT01195467||
739626|NCT01195415||
739627|NCT01195363|Participants were recruited in our University, Center for Healthcare Services, and by televison ads between Oct 2007 and January 2011.|Patients screened over a 7 day period.
739628|NCT01195272||
739629|NCT01195116||
739630|NCT01195103|Patients were recruited from Mayo Clinic, Arizona from March 1 - 11, 2011.|
739631|NCT01195090|The study was started from 01 OCT 2009 to 27 SEP 2011|"we screened 135 patients and 120 patients were randomized in a 1: 1 ratio to one of the treatment groups.
~reson for excluded: 4 patients: ALT or AST >2.5x ULN 8 patiens : withdraw informed consent 3 patiens: baseline A1C>11%"
739632|NCT01195025|10 Healthy male volunteers 18 to 50 years old|Random crossover study, with at least one week between every study occasion.
739633|NCT01194999|Recruitment occurred over the course of one year (October 2010 - October 2011). Patients requiring pubovaginal sling procedures for stress incontinence were invited to participate if they possessed limited comorbidities.|No significant pres-assignment measures were taken.
739634|NCT01194973|A total of 44 patients diagnosed with aHUS signed the informed consent and of these, 41 patients were treated. Three patients were excluded from the study due to failed screening procedure and did not receive eculizumab.|At screening, patients had to have signs or symptoms of hemolysis; serum creatinine level ≥ ULN and platelet count < LLN
739635|NCT01194908||
739636|NCT01194869|Patients were recruited at Winship Cancer Institute of Emory University, Emory University Hospital Midtown, and Grady Health System. The study closed to accrual in June 2015.|
739637|NCT01194856||
739638|NCT01194830||
739639|NCT01194804||
739640|NCT01194674||
739641|NCT01194570||A total of 943 participants were screened and 732 were randomized into the study, of which 725 received at least one dose of placebo or ocrelizumab. A total of 549 participants were ongoing with double-blind treatment at the clinical cut-off date (CCOD).
739642|NCT01194531||
739643|NCT01194479|Healthy subjects and Type 1 Diabetics were recruited to participate in the study. Subjects in either arm were randomized to receive a placebo or the study drug: Formoterol in either the first or second visit.|
739644|NCT01194466|This prospective, randomized, double-blinded, and placebo controlled study was conducted between May 2011 and August 2012 at the University of Iowa Hospitals and Clinics (Clinical-Trials.gov identifier, NCT01194466)|Study exclusion criteria were (1) TENS use within 5 years, (2) conditions precluding TENS use (pacemaker, nickel allergy), (3) pain intensity less than 1 of 10 with rest or swallowing, (4) sensory impairment (could not identify sharp and dull stimuli on face), and/or (5) inability to read, write, or follow directions.
739645|NCT01194453||
739814|NCT01186705||
739647|NCT01194427|Patients will be recruited through the breast cancer clinics at each of the participating centers (ie, Johns Hopkins).|Women 18 years or older with a histologically confirmed diagnosis of invasive mammary carcinoma on a core needle biopsy and with adequate organ function who are awaiting a definitive surgical procedure or initiation of neoadjuvant chemotherapy are eligible.
739648|NCT01194414|A total of 1262 participants at 209 centers in 25 countries were randomized into the study.|
739649|NCT01194297|Subjects recruited during influenza season 2010-2011|No significant pre-assignment details
739650|NCT01194271|Recruitment period: September 1, 2010 to June 5, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.|
739651|NCT01194258||The study included an open-label titration period of at least 4 weeks and up to 6 weeks prior to randomization at Week 0.
739652|NCT01194245||The study included an open-label titration period of at least 4 weeks and up to 6 weeks prior to randomization at Week 0.
739653|NCT01194219|The study was conducted at 76 study centers in 8 countries|
739654|NCT01194154||Total 241 participants were enrolled, 2 participants in the Mircera group and 4 participants in the placebo group did not receive medication.
739655|NCT01194089|Subjects were enrolled at Mayo Clinic in Rochester, Minnesota from August 2010 to March 2014.|95 subjects randomized; 48 to Placebo arm, and 47 to Nicotine arm. On the Placebo arm one subject had their surgery rescheduled and did not take part in the study, leaving 47 starting. On the Nicotine arm 3 subjects withdrew consent prior to surgery and 1 subject's surgery was cancelled, and 1 subject surgery rescheduled, leaving 42 starting.
739656|NCT01193920||
739657|NCT01193907|Date of first enrollment: 04 OCT 10 Date of last visit: 18 NOV 10|
739658|NCT01193868|Recruitment Period: September 15, 2010 to June 29, 2012. Recruitment done at The University of Texas MD Anderson Cancer Center.|Study terminated early as a result of discontinued production of the study drug.
739659|NCT01193842||
739660|NCT01193686|Both types of study participants were recruited from Veterans who were seen in Polytrauma Clinics at the Polytrauma Network Site. Both types of participants were referred by clinicians based on their clinical knowledge of whether this intervention seemed indicated; Recipients could also self-refer based on printed information.|400 Veterans were considered by the interdisciplinary polytrauma team as candidates for PV training. Of these, 29 (7%) were nominated. Of these, 14 (48%) were not enrolled: 6 (21%) due to time or travel restrictions, 6 (21%) could not be reached, and 2 (6%) because they had either been injured too recently or not participated in enough therapies.
739661|NCT01193660|Enrollment Period: May 31, 2010 through April 9, 2011 All participants were recruited at CHA Bundang Medical Center.|We tried to recruit 106 subjects. Finally 105 patients were enrolled at the beginning of the overall study and none of the participants were washed out before assignment to groups.
739662|NCT01193608||
739663|NCT01193582|This report presents results following completion of all vaccinations, including data from the 12-month follow-up. This study was conducted at one site in China.|Participants were enrolled into 1 of 4 groups based on inclusion/exclusion criteria without a screening period.
739664|NCT01193556||
739665|NCT01193530|Recruitment Period: June 16, 2011 to February 08, 2012. All recruitment done at The University of Texas MD Anderson.|Study was halted early due to low accrual, many prospective participants did not meet inclusion and exclusion criteria.
739666|NCT01193517|Recruitment Period: August 2010 to August 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.|
739667|NCT01193348|A total of 27 patients diagnosed with aHUS signed the informed consent and of these, 22 patients were treated. Five patients were excluded from the study due to failed screening procedure and did not receive eculizumab.|At screening, patients had to have a platelet count < lower limit of normal range (<LLN) and serum creatinine level > 97 percentile for age; and had to exhibit signs or symptoms of hemolysis at the start of the current aHUS event with fragmented RBC and a negative Coombs test.
739668|NCT01193335||
739669|NCT01193283||
739670|NCT01193257|Participants took part in the study at 260 investigative sites in North America, Europe, Argentina, Australia, Brazil, Chile, China, Colombia, Israel, Japan, Mexico, New Zealand, Singapore, South Africa, South Korea, and Taiwan from 15 November 2010 to 29 February 2016.|Male participants with a historical diagnosis of metastatic-castration resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy were enrolled in 1 of 2 treatment groups: Orteronel 400 mg + Prednisone 5 mg or Placebo + Prednisone 5 mg.
739671|NCT01193244|Participants took part in the study at 324 investigative sites in North America, Europe, Australia, Brazil, Chile, Colombia, Hong Kong, Peru, Puerto Rico, Israel, Japan, Mexico, New Zealand, Singapore, South Africa, and Taiwan from 19 October 2010 to 7 April 2016.|Male participants who were chemotherapy-naive and had metastatic castration-resistant prostate cancer (mCRPC) with documented progressive metastatic disease were enrolled in 1 of 2 treatment groups to receive Orteronel 400 milligram (mg) + Prednisone 5 mg or Placebo + Prednisone 5 mg.
739672|NCT01193218||
739673|NCT01193153||Participants without previous exposure to paliperidone extended-release (ER) (Invega), or risperidone, received paliperidone ER 6 milligram (mg)/day for 4 to 6 days (during Screening) to test oral tolerability. Only participants, who had ability to tolerate the drug, as judged by treating physician, were eligible for enrollment in the study.
739674|NCT01193127||
739675|NCT01193114||
739676|NCT01193101|This study comprised 3 periods: a 4 week washout and placebo run-in period, an 8 week randomized, double-blind period and a 1 week single-blind, placebo withdrawal period.|In the run-in period, 457 participants were enrolled. Of the 457 participants, 389 participants were eligible for randomization and randomized in a 1:1:1:1 ratio to each treatment group.
739677|NCT01193049||
739678|NCT01193010||
739679|NCT01192828|Subjects were screened and recruited from three sites in the United States.|After enrollment a washout period for medications was required. At first study visit, assignment to arm occurred. One individual, while consented, did not participate at first study visit due to acute illness, was never rescheduled, and was removed. Number of subjects who started arm and completed study was thus 14.
739680|NCT01192815|Patients recruited from local medical clinic from January 2011 through May 2012.|
739815|NCT01186692||
739816|NCT01186562||
739817|NCT01186458||
739681|NCT01192776|1261 infants assessed for eligibility. 897 were excluded for not meeting eligibility criteria (N=747) or not having parental or physician consent (N=150).|All eligible infants with consent were randomized to one of four treatment arms/groups.
739682|NCT01192698||
739683|NCT01192542||There were 39 enrolled, with one screen failure prior to randomization, leaving 38 starting and completing the study.
739684|NCT01192516|Potential participants were recruited through fliers and advertisements.|
739685|NCT01192412||
739686|NCT01192399||
739687|NCT01192347||177 subjects were enrolled, but 2 never received Anagrelide Hydrochloride (Xagrid) and were excluded from the trial (n = 175).
739688|NCT01192295|First Patient First Visit: 28-Feb-2011; Last Patient Last Visit: 29-Jul-2014. The study was conducted at medical/research sites in the United States, Spain, United Kingdom, Greece, Guatemala, Hungary, Israel, and New Zealand|
739689|NCT01192282|All female patients with genital warts referred to the Colposcopy Clinic of Groote Schuur Hospital, Cape Town, South Africa between 1st April 2010 and 30 September 2010. Those who were pregnant or too frail or ill for a gynaecological examination were excluded.|No Applicable.
739690|NCT01192204||41 patients were enrolled in this protocol. 1 patient could not keep the appointments and was referred to his private oral surgeon.
739691|NCT01192191||A 2-week Run-in Period was used to obtain Baseline assessment of participants. The Run-in Period was followed by a 52-week Double-blind Treatment Period and a 1-week Follow-up Period.
739692|NCT01192178||
739693|NCT01192152||Participants underwent screening evaluations to determine eligibility within 21 days before dosing, and were admitted to the clinical facility the evening before dosing (Day -1). On Day 1 of Period 1, a total of 30 participants who met all of the inclusion and none of the exclusion criteria were randomly assigned to 1 of 2 treatment sequences.
739694|NCT01192139||Participants underwent screening evaluations to determine eligibility within 21 days before dosing, and were admitted to the clinical facility the evening before dosing (Day -1). On Day 1 of Period 1, a total of 30 participants who met all of the inclusion and none of the exclusion criteria were randomly assigned to 1 of 6 treatment sequences.
739695|NCT01192126|This was a two week, multicenter, open label, bilateral, crossover study. First Participant was enrolled 08/23/2010 and last participant exited the study 10/08/2010.|102 participants(204 eyes) were enrolled in this study.
739696|NCT01192100||
739697|NCT01192022|Adult participants took part in the study at 19 investigative sites in the United States from 31 August 2010 to 07 November 2012. Pediatric participants took part in the study at 5 investigative sites in the United States from 09 March 2012 to 03 May 2013.|Adult and pediatric participants were enrolled equally in 1 of 2 treatment groups, TachoSil or Surgicel Original, applied once or twice if needed intraoperatively during a 10-minute observation period, or until hemostasis was obtained. Pediatric enrollment continued in an extension phase where all participants were allocated to TachoSil.
739698|NCT01191944||Whilst 475 patients were enrolled only 473 were treated, since one patient was not compliant to protocol and did not take any trial drug and another refused to take trial medication.
739699|NCT01191840||
739700|NCT01191827||
739701|NCT01191801|320 patients enrolled in 30 US sites:391 patients enrolled at 71 sites outside of the US (Canada, Europe, Australia, New Zealand, and Republic of Korea)|Six patients were randomized but never received treatment due to death prior to beginning treatment: 4 assigned to receive vosaroxin/cytarabine; 2 assigned to receive placebo/cytarabine.
739702|NCT01191788||
739703|NCT01191762|Patients with eGFR < 60 were recruited from renal clinics and randomized to receive 3 tablets of sevelamer or placebo with each meal for four weeks.|Randomization was preceded by a 4-week course of vitamin D (dose determined by plasma [25OHD]) and then by a 4-week period of dietary phosphate restriction. The phosphate restriction was continued through the therapeutic trial.
739704|NCT01191749|Recruitment Period: August 27, 2010 to November 22, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Study closed due to slow accrual and change in drug availability.
739705|NCT01191736||
739706|NCT01191723||This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.
739707|NCT01191476|Subjects between the ages of 18 and 65 were recruited from 4 hospitals in 4 cities in China. They were required to have elective laparoscopic, in-patient surgery with a predicted anesthetic duration between 1 to 3 hours. Subjects with ASA physical status I or II were enrolled and were to have had the ability to provide informed consent.|The study was a prospective, randomized (1:1:1), open-label, multi-center study comparing the cost of inhalational anesthesia with sevoflurane to intravenous (IV) anesthesia with propofol, or propofol for induction and sevoflurane for maintenance of anesthesia. The full analysis set was used for determination of all primary and secondary endpoints.
739708|NCT01191411||
739709|NCT01191398||
739710|NCT01191333||
739711|NCT01191320||
739712|NCT01191268||
739713|NCT01191255||"Only subjects that completed the SAP on KRX-0502 were eligible to be included in the EAP
~in the EAP, subjects received only Placebo or KRX-0502-EAP
~3 Subjects switched from 'Active Control' to KRX-0502 during the SAP and were randomized into the EAP
~In the 'Active Control' group, a combination of phosphate binders was allowed"
739714|NCT01191242||
739715|NCT01191190||
739716|NCT01191086||
739717|NCT01191008||A total of 661 participants were registered in the study. Of the 661 participants, 28 participants were excluded from the study because their case report forms were not collected. Finally, 633 participants were included in the study.
739718|NCT01190930|Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)|Patients were stratified between 2 disease groups (B-ALL and B-LLY) for Induction and then risk assigned treatment based upon the patient's response.
739719|NCT01190891||
739720|NCT01190878||
739818|NCT01186419||
739819|NCT01186406|Study recruitment was stopped early due to unacceptable toxicity after 41 participants were enrolled.|Forty-seven subjects were consented to the study. Six subjects were screen failures and were not enrolled.
739721|NCT01190865|Subjects were enrolled at a single US investigational site, between September 14, 2010 and December 08, 2010.|Subjects underwent buccal smear to ensure absence of a Y chromosome or translocated material from a Y chromosome. Day 1, all subjects underwent a baseline 3mm skin punch biopsy on the inner upper arm followed by a single application of HP802-247.
739722|NCT01190839||
739723|NCT01190813|Between September 2010 and October 2013, 139 participants from 27 sites were randomly assigned to levodopa (n=90) or placebo (n=49).|
739724|NCT01190566||
739725|NCT01190527||
739726|NCT01190514||Participants randomized to an open-label treatment sequence beginning in Period 1 with 25 milligrams as 2 tablets (25 mg*2) in fed state=A; or a 50 mg tablet in fed state=B; or 25 mg*2 tablets in fasted state=C; or a 50 mg tablet in fasted state=D in a cross-over, 4-period design. Treatment groups sequenced as: ABCD, BADC, CDAB, and DCBA.
739727|NCT01190475||
739728|NCT01190449||
739729|NCT01190436||
739730|NCT01190410|The study started to enroll patients in August 2010 and concluded in November 2017.|The study included an Open Label treatment period, having 16 subjects enrolled in the Safety Set (SS) shown in the Participant Flow.
739731|NCT01190306|Patients were recruited from August, 2010 to December 2011 from medical clinics throughout the country.|Patients that were excluded from the clinical trial were considered screen failures due to not meeting one or more of the inclusion/exclusion criteria.
739732|NCT01190267||
739733|NCT01190254||
739734|NCT01190228|Study participants were enrolled from 25 August 2010 to 12 October 2015 at 3 clinic sites in the Philippines.|A total of 454 participants who met all inclusion criteria and no exclusion criteria were enrolled in Group 1 or randomized to Group 2 or Group 3 on Day 0. All except 4 participants in Group 1 were vaccinated as planned (345 participants in Group 1, 46 participants in Group 2, and 59 participants in Group 3).
739735|NCT01190215||
739736|NCT01190202|For each year and each site, approximately 400 subjects at least 6 months and < 5 years old, approximately 200 subjects at least 5 years and < 20 years old and approximately 200 subjects at least 20 years old were to be enrolled. The study was conducted at 8 sites and 6 countries for the first 3 surveys and 3 sites from 3 countries for Survey 4.|
739737|NCT01190189|This study was conducted by multiple investigators at 28 centers in Canada and the United States.|All subjects enrolled were vaccinated and included in the Total Vaccinated cohort (TVc).
739738|NCT01190176|This study was conducted by multiple investigators at 20 centres in Canada, Netherlands, Portugal, Russian Federation, Singapore, United Kingdom and the United States.|Although 34 subjects were enrolled in the study, 2 were excluded following eligibility criteria, leading to 32 subjects who started the study.
739739|NCT01190150||
739740|NCT01190124|Retrospective collection of data took place in 11 portuguese public hospitals. Each site included patients who started treatment with raltegravir from March 2007 until December 2008.|197 patients were included in the database. However, only 151 patients were included in the analysis, as 46 did not meet inclusion/exclusion criteria
739741|NCT01190098||52 subjects randomized, 59 subjects enrolled. The 7 either were either screen failures or chose not to proceed with the study.
739742|NCT01190085|Individuals were recruited via advertisements in local public transportation and mass-media|
739743|NCT01190020||
739744|NCT01190007||
739745|NCT01189890||
739746|NCT01189812|There were 93 patients screened to meet the enrollment target of 80 randomized subjects into this study. Subjects were recruited from two clinical research centers beginning in March 2010. One site was located in Bellevue, WA, and the other in San Diego, CA. The last patient was screened in December 2010.|After a patients enrolled in the study, the washout period for any excluded concomitant medications was kept to a minimum to avoid potential risk to this severely ill population.
739747|NCT01189760||
739748|NCT01189747||
739749|NCT01189617||
739750|NCT01189604|A total of 2 centers were initiated with first patient enrolled on 23 August 2010 and last patient completed on 17 November. A total of 129 patients were enrolled with 123 qualified patients allocated to randomized treatment.|The patients enrolled in this study were undergoing non-emergent standard esophagogastroduodenoscopy (EGD) or colonoscopy. Six patients were withdrawn from the study after enrollment but before randomization: 5 patients due to excess recruitment and one patient due to investigator's recommendation..
739751|NCT01189500||
739752|NCT01189487||
739753|NCT01189461||
739754|NCT01189435||
739755|NCT01189409||
739756|NCT01189370||
739757|NCT01189292|Patients older than 18 years scheduled for a primary partial or total thyroidectomy due to benign disease at the Kantonsspital St. Gallen, Department of Surgery were recruited.|
739758|NCT01189279||Part 1 of the study was double-blind, followed by Part 2 which was open-label. No patients enrolled in Part 1 were enrolled in Part 2 of the study.
739759|NCT01189266|Phase I /II study. Phase I determined Maximum Tolerated Dose between the first 2 treatment arms; zero patients completed therapy. Study was closed, then reopened to accrual. Phase II enrolled an additional 67 patients. Overall, 79 patients were enrolled but only 2 patients completed all 12 cycles of maintenance chemotherapy.|
739760|NCT01189240|Phase I trial started 8/2011 and enrollment closed 7/31/12. 13 total patients treated by RO4929097 (5, 10, 20mg/kg) in combo with bevacizumab. 1 treated pt ineligible for study. Analysis data for toxicity included 13 treated pts. Analytical dataset results other than toxicity included 12 eligible pts only. Pts enrolled from outpt medical clinics|A decision was made from the company, Roche, the owner and developer of RO4929097, that as of 7/31/12 there would be no further supply of RO4929097 and all clinical trials using this drug must stop accruing and treating patients. Hence our ABTC 1002 study was stopped during the phase 1 with 13 pt accrued and the Phase 2 was unable to begin.
739761|NCT01189227||
739762|NCT01189201||
739763|NCT01189136|112 subjects invited to participate, 28 declined, and 84 were equally distributed between treatment and sham groups|
739764|NCT01189123||
739909|NCT01181531|Participants were enrolled from 08 September 2010 through 14 August 2012 Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.|
739765|NCT01189110|"Participants were recruited between August 2010 and January 2011 at the St. Louis VA. The inclusion criteria were age 19 years or older and currently smoking ≥10 cigarettes per day.
~Two hundred thirteen veterans who either responded to a mailing or were referred by their primary care physician expressed interest in the study."|Seventeen were excluded due to eligibility criteria. The remaining 196 were scheduled to attend a 1-hour smoking cessation class. Twenty-nine did not attend. Eleven did not keep the consent appointment. Another 31 did not enroll for other reasons. Thus, 125 participants were randomized: 64 to the intervention group and 61 to the placebo group.
739766|NCT01189071|Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.|
739767|NCT01189032||Excluded (n=34)
739768|NCT01188967||84 participants signed consent and 40 of those participants were found ineligible. 11 participants voluntarily withdrew consent. 4 participants were terminated by the investigator for reasons other than toxicity/adverse events (ie noncompliance). 11 participants were lost to follow up.
739769|NCT01188928|The first subject's first visit was on 27-SEP-2010 and the last subject's last visit was on 29-MAR-2011. Hence the study had a duration of 26 weeks.|
739770|NCT01188876||
739771|NCT01188811||
739772|NCT01188798|Six transplant patients were recruited between December, 2010 through March, 2011. Participants will be biologically stratified according to disease, donor, and KIR match.|
739773|NCT01188772|Subjects were enrolled in a total of 22 study sites in the United States. The first participant was screened on 16 August 2010. The last participant observation was on 11 May 2012.|147 participants were randomized, and 146 participants received at least one dose of study drug, and comprise the Safety Analysis Set.
739774|NCT01188694||
739775|NCT01188681||
739776|NCT01188668||
739777|NCT01188655||
739778|NCT01188603||
739779|NCT01188577|Participants were recruited from a specialty clinic in Cypress, CA between 08/19/2010 and 09/09/2010.|A total of 35 subjects were screened, 23 subjects passed screening, consented and were randomized for participation in the study.
739780|NCT01188564|During the double blind phase of the study, patients were randomized once to receive rhC1INH or Saline in a ratio of 3:2. After the randomized treatment, patiënts with subsequent attacks could be trated with open-label rhC1INH.|Patients could be enrolled into the open-label phase of the study after the initial randomized treatment.
739781|NCT01188551|Patients were recruited from the outpatient ENT surgery service at Nationwide Children's Hospital.|
739782|NCT01188538|40 patients have been enrolled in one site in Poland: First subject included: March 3, 2010; last subject out: August 23, 2010|
739783|NCT01188499||
739784|NCT01188460||
739785|NCT01188447||
739786|NCT01188421||
739787|NCT01188369||
739788|NCT01188343|Study participants were enrolled from 14 August 2010 through 28 July 2011 at 5 clinic centers in Taiwan.|A total of 550 participants who met all of the inclusion and none of the exclusion criteria were randomized, 542 were vaccinated and reported.
739789|NCT01188226||
739790|NCT01188109|Patients who underwent resection of a pancreatic adenocarcinoma (PDAC) were enrolled postoperatively at Winship Cancer Institute of Emory University from 2010-2013.|Twenty-five patients were initially enrolled. Three patients were thereafter excluded; two were diagnosed with secondary malignancies (primary lung adenocarcinoma and thyroid cancer), and one had a diagnosis of cholangiocarcinoma on final surgical pathology.
739791|NCT01187953||
739792|NCT01187914|Patients were recruited based on chart review|
739793|NCT01187901||
739794|NCT01187771||Between enrollment and assignment, 3 participants withdrew their consent to participate and 1 participant's physician withdrew the determination of eligibility.
739795|NCT01187550||Out of 214 participants enrolled in the study, 1 participant could not be categorized as appropriate for gestational age (AGA) or small for gestational age (SGA) since weight and height at birth was not available.
739796|NCT01187511||
739797|NCT01187498|Participants were recruited through mailed surveys about bladder symptoms and through clinics at two Veterans Affairs Medical Centers(2005-2009).|To minimize possible effect of undetected obstruction we used a 4-week alpha-blocker run-in (tamsulosin 0.4 mg/d or alternative). Participants who continued to meet inclusion criteria after run-in were randomized. Alpha-blocker therapy was continued throughout the trial, unless not tolerated.
739798|NCT01187446||
739799|NCT01187433|Study participants were enrolled from 20 August 2010 to 8 December 2011 at 1 clinical site in Brazil.|A total of 150 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
739800|NCT01187407||The first 3 weeks of the study was a double-blind Confirmation Phase during which participants continued to receive their SSRI with adjunctive placebo. If randomization criteria were met, participants were randomized to adjunctive LY2216684 or adjunctive placebo. If criteria were not met, participants continued on placebo to maintain the blind.
739801|NCT01187381||
739802|NCT01187355|Subjects were recruited and enrolled from 42 US study centers.|The Participant Flow Chart includes all randomized patients: 591. Baseline characteristics are presented for all subjects who received test article and had at least one on-regimen study visit: 578.
739803|NCT01187329||
739804|NCT01187043||
739805|NCT01187017||
739806|NCT01187004|We enrolled all patients undergoing a cardiac surgery intervention on cardiopulmonary by pass (CPB)|Patients were excluded for: Intensive Care Unit - Length of stay (ICU-LOS)<24h, age < 18 yrs old; mechanical ventilation before surgery; Acute Lung Injury (ALI) at the admission to Intensive Care Unit (ICU); heart and lung transplant
739807|NCT01186978||
739808|NCT01186939||Participants were eligible for the extension study of AZA PH GL 2003 CL 001 if they had been randomized to azacitidine treatment in the primary study and receiving azacitidine at the time of study closure, completed 12 months of treatment and observation in the primary study, and signed the informed consent document for the extension study.
739809|NCT01186848|Recruitment period took place over approximately 6 months at an urban academic hospital.|
740018|NCT01175356||
739820|NCT01186328|3 patients were initially enrolled onto Dose Level 1. 1 of 3 patients were found to experience a dose limiting toxicity. 3 additional patients were enrolled onto dose level 1. Another 1 patient was found to experience a DLT that was deemed possibly related to study medication EZN-3042. Study dose was deescalated to dose level 0.|
739821|NCT01186250||
739822|NCT01185964||Participants who had evidence of progressive disease (PD), died, or received optional olaratumab treatment on the doxorubicin (dox) monotherapy arm were considered to have completed the study. This includes participants who discontinued treatment due to non-PD reasons, but had PD at End of Study.
739823|NCT01185834|Thirteen US optometry sites recruited and enrolled subjects for this study.|
739824|NCT01185821|All patients enrolled in the Extension study had completed the Core study. All patients underwent a 10 day titration at the start of the dose blinded phase of the study|During the double blind phase of the extension study patients received the same dose from the Core study. Placebo patients from Core Period 1 were randomized to 0.5, 2 or 10mg, those from Period 2 were randomized to 0.25 or 1.25 mg. All patients received 2mg in Open Label phase (.5 and .25mg were titrated up to 2mg)
739825|NCT01185782|Participants were recruited in 21 study centers in Japan from 15 February 2007 to 25 December 2007.|300 participants were enrolled in the study; 39 participants discontinued prior to Investigational Medicinal Product (IMP) administration (35 participants for no longer meeting the eligibility criteria 4 due to Adverse Events [AEs] or other reasons). Demographic data was not available for the 4 participants who were randomized but not treated.
739826|NCT01185704||
739827|NCT01185639||
739828|NCT01185600||
739829|NCT01185561|Participants were recruited between March 2007 and November 2009|Eighty-four participants consented to participate in the study. Among these individuals, 10 (11.90%) were not randomized and were excluded from continuing their participation in the study because the medical monitor determined they had a significant psychiatric history, had a history of alcohol or drug abuse, or were not depressed.
739830|NCT01185548||
739831|NCT01185522|A total of 719 participants were enrolled in this study conducted from Jan 2010 to May 2011 at 20 centers in France|Of 719 participants, 25 did not respect inclusion criteria (age less than 18 years or missing age, no or missing attestation of information about the study) and one did not receive any tocilizumab (RoActemra®) infusion.
739832|NCT01185509|Patients enrolled from November 2010 through July 2014.|
739833|NCT01185353||This study consisted of 4 parts and a follow-up up to 28 days post the last dose of study drug.
739834|NCT01185340||The first 3 weeks of the study was a double-blind Confirmation Phase during which participants continued to receive their SSRI with adjunctive placebo. If randomization criteria were met, participants were randomized to adjunctive LY2216684 or adjunctive placebo. If criteria were not met, participants continued on placebo to maintain the blind.
739835|NCT01185301||
739836|NCT01185288||
739837|NCT01185249|"Once all admission procedures were completed in the cardiac intermediate unit, the nursing staff asked CHF patients in their care, if they had interest in hearing more about the study. After a verbal yes, the PI or key personnel met with the patient to explain the study, review the consent form, and after ample time, obtain written consent."|
739838|NCT01185171|From February 2003 to October 2004, 70 patients signed consent at three participating institutions.|1 patient withdrew before initiating therapy and was not included in the trial. 10 patients underwent surgery to remove all gross disease before initiating study and were unevaluable for response.
739839|NCT01185080|"There were 93 patients enrolled in the study, who 83 of them were randomized. Of the 10 patients who were not randomized, 3 patients due to patient decision and 7 patients due to Eligibility criteria not fulfilled were not randomized."|
739840|NCT01185028||
739841|NCT01184989||30 patients did not receive any study medication.
739842|NCT01184898||
739843|NCT01184885||
739844|NCT01184872||
739845|NCT01184859||139 patients randomized and 116 treated. Withdrawals during the screening period were due to urine production did not meet >0.12 mL/kg/min within 2 hours of dosing (22 patients) and violation of inclusion/exclusion criteria (1 patient).
739846|NCT01184846|This multicenter study enrolled subjects at 13 participating study centers in 5 countries in Europe.|"A total of 31 subjects were screened and 28 were eligible.
~Intravenous immunoglobulin (IVIG)-untreated subjects: screening took place up to 3 weeks prior to the first IgPro10 infusion
~IVIG-pretreated subjects: Screening took place at any time at or after the last dose of pre-study IVIG (up to 10 weeks prior to the first IgPro10 infusion)"
739847|NCT01184755||
739848|NCT01184508||Prior to randomization, participants completed screening and washout followed by a 28-day baseline period to determine the number of migraine attacks participants experienced without the use of preventative medications. Participant Flow and results based on participants, post-randomization (12-week treatment and 4-week follow-up periods combined).
739849|NCT01184456||PI has left AIDS Healthcare Foundation, all efforts to locate the data have been exhausted and no data is available.
739850|NCT01184417||
739851|NCT01184326|Participants were enrolled between January 2011 and July 2016 including dose finding 1/1/2011-9/23/2011 and expansion 3/9/2015-7/25/2016.|
739852|NCT01184118||
739853|NCT01184079|From October 2010 through May 2011, college age men, ages 18-25 years, were recruited using a variety of strategies including fliers, class announcements, recommendations by university health centers, emails to campus organizations, bus and campus newspaper advertisements, and targeted Facebook® advertisements.|Exclusion criteria were: >4 lifetime sexual partners, health problems that would interfere with the immune response or ability to complete the study, a hospitalization during the past year, hypersensitivity to yeast or HPV vaccine components, inability to complete appointments, received HPV vaccine or immunosuppressive medications.
739854|NCT01184053|Women 18 years of age with histologically confirmed metastatic or recurrent endometrial cancer at the Lineberger Comprehensive Cancer Center|
739855|NCT01184014|Recruitment from May 2011 to August 2012. Location: Hospital.|
739856|NCT01183975|The cohort consisted of 517 cases of the SAGB implanted by 31 surgeons recruited between 02 SEPT 2007 and 30 April 2008.|
739857|NCT01183923||
739858|NCT01183897||
739859|NCT01183884||
739860|NCT01183858||315 participants were randomized. 313 participants were included in the Intent-to -treat (ITT) population. The ITT population excluded 2 randomized participants: 1 participant randomized in error and 1 participant with missing source data.
739861|NCT01183780||Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.
739862|NCT01183728||
739863|NCT01183689|SNAP targeted an enrollment of 600 participants, aged 18-35 years, with a BMI of 21.0 to 30.9. Participants were recruited from 2 clinical sites (Providence, RI and Chapel Hill, NC). The final sample of 599 participants (27% minority, 22% male) was recruited over a 19-month period (Aug 2010-Feb 2012).|Participants were pre-screened online and by telephone before attending an orientation, followed by two screening visits. 609 participants were randomized; although 10 participants never attended the randomization visit and did not learn of their group assignment.
739864|NCT01183650||
739865|NCT01183546||
739866|NCT01183533|Study was open for enrollment (began recruiting and screening for eligible patients) on July 13, 2010. The date of first enrollment was October 5, 2010 and the date of last enrollment was October 5, 2013. All patients were enrolled at one of five participating centers.|
739867|NCT01183481|Patients were enrolled between January 2011 and October 2012 in a radiation oncology clinic|No enrolled patients were later excluded.
739868|NCT01183468|Twelve of the fifteen centers enrolled a total of 17 newly diagnosed (within 100 days of Visit 0 first low dose infusion) Type 1 Diabetes Mellitus participants.|
739869|NCT01183429||
739870|NCT01183416||
739871|NCT01183390||
739872|NCT01183312|Participants were recruited from the Sleep Center of the Emory Clinic, in Atlanta, Georgia, USA, between December 2010 and October 2011.|12 patients were enrolled; of these, 2 were excluded prior to randomization because screening laboratory test results were abnormal.
739873|NCT01183260|Recruitment period: 2010 - 2014|
739874|NCT01183234||
739875|NCT01183169||
739876|NCT01183143||
739877|NCT01183104||
739878|NCT01183065||
739879|NCT01183013|After Amendment #5, patients were considered COMPLETED at the end of Part A (30 weeks) or after their next Part B visit (up to 54 weeks) if already in Part B. Before Amendment #5, all patients were considered COMPLETED at the end of Part A + Part B (84 weeks).|
739880|NCT01182844|Thirty-five subjects were screened for the study between January and August 2010; 30 patients were finally included, whereof 28 finished the study (2 dropped out due to withdrawal of informed consent). Five patients did not fulfill the inclusion criterion of fasting glucose above 100 mg/dl at the day of screening any more.|
739881|NCT01182805||
739882|NCT01182727|Participants were recruited from August 2010 to August 2011 from multiple community mental health clinics.|Participants were withdrawn from the trial if they had abnormal lab values or were found to have a diagnosis of diabetes.
739883|NCT01182675||
739884|NCT01182610|10 sites associated with Accelerated Coummunity Oncology Research Network, Inc. (ACORN) or Georgia Center for Oncology Research and Education (GA-CORE)participated in this study. Enrollment started in May 2011 and was closed in November 2011 due to toxicities observed in a similar trial.|Informed consent was obtained from the subject. The Subject underwent a screening period of up to 35 days during which pre-study assessments were completed.
739885|NCT01182493|36 hospitals, tertiary care centres, and referal centres participated: eight in Canada, 23 in Europe and Israel, two in South Africa, and three in the USA. The study started in December 2010, and the fi nal data collection date for the primary outcome measure was in February 2014|
739886|NCT01182480|English and Spanish-speaking adult patients (18-76 years old) with diabetes in possession of cell phones who receive primary care at Sam Sandos Westside Family Health Center (Westside), a federally qualified community health center in the Denver Health integrated healthcare system in Denver, CO.|Exclusion criteria included a life expectancy less than six months, age < 18 or > 76, and either lacking possession of or inability to use a cell phone or glucometer.
739887|NCT01182441||
739888|NCT01182428|Patients were recruited between 30 Sept 2008 and 02 December 2009, from the general female interventional cardiology population who had been admitted for a PCI procedure.|
739889|NCT01182415||
739890|NCT01182376||
739891|NCT01182350|Study screening procedures were conducted at 23 sites in the United States. Eligible participants enrolled between September 2011 and September 2015.|
739892|NCT01182337||
739893|NCT01182298||
739894|NCT01182285||Five and eight participants were enrolled from University of California San Francisco (UCSF) and the National Institutes of Health (NIH), respectively.
739895|NCT01182207||
739896|NCT01182194||
739897|NCT01182181||
739898|NCT01182103|From August 1st, 2000 to July 31st, 2012, major depressive disorder patients were recruited from Kaohsiung Chang Gung Memorial Hospital, a tertiary medical center.|
739899|NCT01181986||
739900|NCT01181947||
739901|NCT01181921||Only one participant was recruited and did not complete the study; therefore no assessments have been conducted throughout the study.
739902|NCT01181895|347 participants (par.) were randomized to treatment; all 347 were included in the Intent-to-Treat (ITT) Population. One par. was not randomized but received treatment in error. This par. was not included in the ITT Population and is thus not captured in the Participant Flow module. This par. is categorized as being enrolled in the study (n=348).|Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline, safety evaluations, and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. A total of 583 par. were screened, and 347 were randomized, of which 298 received at least one dose of study treatment.
739903|NCT01181804||
739904|NCT01181778||
739905|NCT01181726||
739906|NCT01181674||
739907|NCT01181609||
739908|NCT01181596|This is an observational study where recruitment took place in the Neonatal Intensive Care Unit. Enrollment period of June 2010 - November 2011.|If participants health worsens prior to assignment they were excluded from the study.
739913|NCT01181323|Participants were healthy post-partum women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 6Sep2011 and 31Oct2012|Maternal participants and their infants were enrolled separately in the study for the purposes of data collection, analysis and reporting. For baseline measures, adverse events, and outcome measures as appropriate, the infants are defined as their own arms of the study based on the study product the mother received.
739914|NCT01181271|Participants were enrolled between October 2010 and June 2013.|
739915|NCT01181258||
739916|NCT01181167||
739917|NCT01181141||
739918|NCT01181128||
739919|NCT01181102||
739920|NCT01181076||As determined
739921|NCT01181050|The trial was conducted at 8 trial sites in 3 different countries (Germany, the Russian Federation and Ukraine) as follows: Germany: 1 site, the Russian Federation: 6 sites and Ukraine: 1 site. All sites enrolled, randomised and dosed at least 1 subject.|
739922|NCT01181011||
739923|NCT01180998|Subjects were recruited and randomized to one of two parallel arms. Three categories of subjects were recruited: spherical soft lens wearers, CL drop-outs, neophytes.|The data from 10 subjects was disqualified from the analysis due to subjects' ineligibility being determined after enrollment.
739924|NCT01180985|This study was a four (4) site, bilateral crossover study. Data were collected in three (3) visits (initial, 1 wk follow-up, and final visit).|Fifty-three (53) subjects enrolled, one(1) subject was discontinued and fifty-two (52) completed the study.
739925|NCT01180894||
739926|NCT01180790|Participants were recruited from 15 sites in the United States and 3 sites in Belgium between September 30, 2010 and January 3, 2012.|Participants screened within 4 weeks (Day -28 to -1) before administration of study drug. Subjects who meet all eligibility criteria were instructed to arrive at the study center on Baseline day for randomization to treatment assignment.
739927|NCT01180777|This study was an eight-site, randomized, 4-visit, bilateral crossover, dispensing trial.|Of those 95 enrolled subjects in this study, 3 did not meet the eligibility criteria, 6 prematurely discontinued from the study, and 6 excluded from the analysis due to protocol deviations.
739928|NCT01180660|51 subjects were randomized and 50 completed the study. Subjects were enrolled consecutively from August 2010 through October 2012.|"60 subjects were assessed for eligibility and 9 were excluded because they did not meet inclusion criteria n=3 or the subject refused n=6.
~51 subjects were randomized to the study"
739929|NCT01180647|Recruitment of participants took place at NYC jail medical clinics (Rikers Island; EMTC, RMSC) with follow-up visits taking place at Bellevue Hospital. The last participant completed in June 2013.|Of the 48 consented participants enrolled into study between January 2010-May 2013, 34 were randomized into one of two trial arms, with n=17 to Extended-Release Naltrexone arm and n=17 to the Motivational Enhancement Counseling Only arm (treatment-as-usual).
739930|NCT01180478||
739931|NCT01180400|This multicenter study was conducted in Europe between 2 September 2010 and 27 September 2011.|The study had an up to 21-day screening/washout period, and an 8-week prospective open-label antidepressant treatment (ADT) period to identify the target patient population of inadequate responders to ADT (<50% reduction in HAMD-17 total score during the prospective open-label ADT period, a HAMD-17 total score of ≥16 and a CGI-S score ≥4).
739932|NCT01180296||
739933|NCT01180244||
739934|NCT01180127||
739935|NCT01180049|The study was conducted at multiple centers from 10 Mar 2011 to 28 Jun 2018.|
739936|NCT01180036||
739937|NCT01179984||
739938|NCT01179919||
739939|NCT01179737|23 participants were enrolled into the study (15 in cohort 1; 8 in cohort 2) 8 participants completed cohort 1 and 6 of these participants moved into cohort 1expansion. Of the 5 participants that completed Cohort 1 expansion; 3 participants went into an Extension. None of the participants completed treatment as trial was terminated|Participants were randomized 6:1 ratio to nilotinib and placebo
739940|NCT01179672||Participants tapered off study drug after either completing the 12 weeks of treatment or discontinued treatment early.
739941|NCT01179568|Bereaved individuals age 18-95 were recruited between March 2010 and September 2014 using professional and public outreach, print, broadcast and internet media. Referrals were made by health care professionals, bereavement counselors and patients or family members.|
739942|NCT01179516|Participants took part in the study at 65 investigative sites in the United States from 11 August 2010 to 04 June 2012.|Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 3 treatment groups, once a day placebo, 10 mg, or 15 mg vortioxetine.
739943|NCT01179490||
739944|NCT01179477|Per the clinical investigation protocol, IDE subjects (n=54) who did not consent to roll over into the post approval study (PAS) at sites participating in the post approval study, were included in primary endpoint analyses. Since these subjects are not enrolled into the PAS, they are not reflected in the participant flow.|
739945|NCT01179399||
739946|NCT01179347||First part: double-blind, duration was 12 weeks, 464 patients were randomised to either Tio R5 or placebo in a 2:1 ratio, but 1 randomised patient was not treated. Second part: open-label, all patients received the active treatment for a minimum of 12 weeks to enlarge the safety database.
739947|NCT01179334|Only participants with symptomatic Pulmonary arterial hypertension (PAH) could participate in this study. Subjects must be on pre-treatment with sildenafil at a dose of 20 mg three times daily (tid) (20 or 25 mg tid in New Zealand) for at least 90 days.|24 subjects were enrolled in 11 study centers in 5 European countries. Six of the 24 subjects were screened but not randomized (screen failure [6]). 18 of the 24 participants were randomized. All of the 18 randomized participants received study medication.
739948|NCT01179217||
739949|NCT01179191||
739950|NCT01179113|Prior to the day of surgery, potential study patients scheduled to undergo spine surgical procedures received a packet of materials from their surgeon. The packet contained an initial patient contact letter, a privacy information sheet, and the institution review board (IRB)-approved informed consent form.|
740019|NCT01175343||One patient was taken off study prior to start of study drug for meeting exclusion criteria 3.2.5 (i.e. patient is taking concurrent medications that are strong inducers, inhibitors or substrates of CYP3A4 who cannot be switched to alternative medications).
739951|NCT01179048|410 sites in 32 countries across the 4 regions recruited subjects. Number of sites that recruited subjects is given in parenthesis. Europe (143), North America (135) (US, Canada) , Asia (33) (China, Taiwan, Korea, India) and Rest of the world (99) (Brazil, Mexico, Australia, South Africa, Turkey, Russian Federation, United Arab Emirates).|All subjects received placebo (0.6 mg/day) during the open labeled run-in period of 2-3 weeks and were instructed on how to administer the trial product. During this period the subjects demonstrated that they could adhere to the injection regimen in the trial.
739952|NCT01178944||
739953|NCT01178853|14 July 2010 - 09 November 2010|
739954|NCT01178827||
739955|NCT01178762|Patients with clinically suspected chlamydial conjunctivitis at the outpatient clinic of Dr Hou at National Taiwan University Hospital (NTUH) between 1 January 2006 and 31 December 2006 were included|Patients with symptoms and signs of chlamydial conjunctivitis suspected were tested for Chlamydia direct fluorescent antibody tests. The patients with positive results were treated with oral azithromycin,except those who were pregnant, lactating,with a history of allergy to macrolides or hepatic, renal,hematological or cardiovascular disease .
739956|NCT01178671||
739957|NCT01178528||
739958|NCT01178385|Forty-five children between 7-11 years (M=8.89, SD=1.34) were recruited through referrals, advertisements, and the patient flow at a university-based mental health clinic. Recruitment took place between March, 2010 and ended around January, 2012.|Seventy-one youth were assessed for eligibility. Twenty-six were excluded because they did not meet eligibility criteria (Did not meet IQ criteria (n=6); Did not meet anxiety criteria (n=9); Parent unwilling or unable to accompany child to all sessions (n=4); No autism spectrum disorder diagnosis (n=7)).
739959|NCT01178333|Of 668 consecutive patients with a positive heparin-PF4 ELISA test, 226 were excluded, primarily due to lack of recent heparin exposure. Of 442 eligible patients, 71 had HIT-T, 284 had Isolated HIT and 87 had no HIT.|
739960|NCT01178294|Enrollment was conducted at 12 clinical sites in 4 countries (USA, Canada, UK, India). Eight sites enrolled subjects under Protocol OBI-1-301 only. Two US sites enrolled subjects under the expanded access protocol OBI-1-301a and subsequently under protocol OBI-1-301. Another 2 US sites enrolled subjects under OBI-1-301a only.|29 subjects were enrolled and all were treated with OBI-1. Data from the expanded access subjects (Protocol 301a, n= 4) are included with the data from subjects enrolled under Protocol OBI-1-301 (n=25). 10 subjects discontinued prematurely and 18 completed the study. For one subject, the completion status could not be verified.
739961|NCT01178281|Participants in the global study were enrolled at 72 clinical centers in 15 countries. In addition, the China-specific extension study enrolled participants with myeloproliferative neoplasm (MPN)-associated myelofibrosis and severe anemia not receiving red blood cell (RBC)-transfusions at 5 sites in China.|Participants in the global study were randomized 2:1 to receive blinded pomalidomide or placebo. All participants in the China extension received open-label pomalidomide. Randomization was stratified by age (≤ vs >65 years), white blood cells (< or ≥25 × 10⁹/L) and baseline transfusion requirement (≤ vs >4 units RBC/28 days over the prior 84 days).
739962|NCT01178268|A total of 488 patients in the Per-protocol (PP) population for final analysis. First Patient Enrolled on August 18, 2010, Last Patient Enrolled on August 31, 2011 and the Final Database Lock was on September 26, 2013. The total patient enrollment rate was 0.5 patients/site/week based on 489 patients enrolled over 54 weeks at 20 sites.|All of the 546 patients, 57 (28:XIENCE;29:CYPHER)were excluded from the Per-protocol (PP) population, leaving a baseline population of 489 patients. Whereas because of patient disposition results in a total of 488 patients in the PP population for final analysis.
739963|NCT01178216|From 2013 - 2017, Highly Sensitized (HS) patients with calculated panel reactive antibodies (CPRA)>50% underwent desensitization while awaiting kidney transplantation|
739964|NCT01178138||
739965|NCT01178125|A total of 3691 women desiring pregnancy prevention were screened for enrollment into this study. Of the 3691 subjects screened, 2858 subjects at 53 centers in the US and 9 centers in Israel met entry criteria and were considered to be eligible for enrollment into the study.|Of the 2858 enrolled, 93 participants withdrew from study before taking any investigational product, for the following reasons: lost to follow-up (n=34), consent withdrawn (n=17), sponsor request (n=13), withdrawn due to pregnancy (n=11), noncompliance (n=6), other (n=6), protocol violation (n=3), adverse event(n=2), investigator request (n=2).
739966|NCT01178099||
739967|NCT01178086||"This single arm study had baseline and analysis reported per 2 arms (Unselected Population and Slow Go Subpopulation)."
739968|NCT01178073|500 participants (par.) in the ITT Population were also included in the modified ITT Population (those who also met the modified inclusion/exclusion criteria defined in the protocol amendment 2). Disposition results below have been presented for the ITT Population.|A total of 610 par. were randomized; however, only 605 were included in the Intent-to-Treat (ITT) Population (randomized par. who received at least one dose of IP). All par. received a minimum of 24 weeks of therapy unless they died or withdrew.
739969|NCT01177969||
739970|NCT01177956|First/last participant (informed consent): December 2009/September 2010. Clinical data cut-off: 25 January 2011, Study completion date: November 2012|A total of 73 participants were enrolled, out of which 5 participants were screen failure and 68 participants received the study treatment.
739971|NCT01177943||
739972|NCT01177813||
739973|NCT01177800||
739974|NCT01177735||
739975|NCT01177722|Participants were enrolled from 03 August 2010 to 23 November 2010 in 2 clinical centers in Columbia and 1 clinical center in Costa Rica.|A total of 1375 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
739976|NCT01177709||
739977|NCT01177670|This study was designed to be conducted at 8-10 clinical sites and enroll 1000 subjects.Enrolled subjects were to have baseline data collected at the time of their procedure and then be followed for 2 years with visits occurring at 3 months following the procedure, 6 months following the procedure, 12 and 24 months post relying date.|
739978|NCT01177553||
739979|NCT01177410|Study Period: 09Aug2010 to 16Aug2011. 20 Study Sites; US Only. Study locations were a variety including: Gastrointestinal, Family Practice, Medical Centers and/or University setting|Failure to meet baseline IBS symptom scores (based on diary responses)
740064|NCT01172821||There was 1 patient in the TIO R2.5 and 1 patient in the TIO R5 group randomized but not treated.
739980|NCT01177384||All participants randomized population. The participant flow module includes the second sequential randomization of a participant in the placebo group. Data for the second sequential randomization were excluded from the efficacy and safety analyses and the reason for not completed was a protocol violation.
739981|NCT01177293||
739982|NCT01177228|Participants took part in the study at 2 study centers in Canada and 9 study centers in Russia, from 02 May 2007 to 16 June 2008.|Participants with active ulcerative colitis were randomized in a 4:1 ratio of vedolizumab to placebo.
739983|NCT01177189||
739984|NCT01177137||
739985|NCT01177098||
739986|NCT01177059||Participants who completed original study (OTH/OZ1-INT-1 [NCT00074997]) were enrolled in this long term follow-up (LTFU) study. After unblinding of original study, participants in placebo group were withdrawn from LTFU study, except first participant who received Moloney murine leukemia virus based retroviral vector (LNL6) transduced CD34+ cells.
739987|NCT01177007|This study enrolled patients diagnosed with unresectable hepatic metastases who have failed or were intolerant to at least one line of systemic chemotherapy or liver-directed therapy. Participants were enrolled at Johns Hopkins Hospital with the last patient completed in April 2015.|
739988|NCT01176968||A total of 1012 subjects were enrolled for participation in this study. A total of 505 subjects were randomized to treatment with eplerenone and 505 subjects were randomized to the placebo group; a total of 422 and 424 subjects in the eplerenone and placebo groups, respectively, completed the study.
739989|NCT01176955||
739990|NCT01176916||A total of 564 participants were assigned into the study and 558 participants received the study treatment. (6 participants were withdrawn from the study prior to the first dose of Aromasin.)
739991|NCT01176877|Between August 2010 and June 2011, 40 subjects were recruited from patients seen for keloid scars at Northwestern University's dermatology clinic in Chicago, Illinois, and from the general population by advertisements in a local newspaper and Internet classified ads.|
739992|NCT01176773||
739993|NCT01176617||44 patients were enrolled over 4 months; 6 patients withdrew: 4 patients had the device removed before study completion and 2 patients did not return for the required follow-up. The remaining 38 patients completed the study requirements and are reported in the final results.
739994|NCT01176591||
739995|NCT01176565|A total of 8,532 patients who presented to enrolling sites for emergency care within 6 hours of symptom onset and were found to have non-traumatic intracerebral hemorrhage (ICH) on head CT imaging were screened for eligibility beginning January 7, 2011. A total of 1000 patients were enrolled in the trial between May 15, 2011 and September 14, 2015.|Consent for participation was obtained from the patient or their allowable representative prior to randomization. All patients randomized were considered as enrolled. Treatment to lower systolic blood pressure (SBP) to the assigned range had to begin within 4.5 hours from symptom onset. Treatment for elevated SBP was not delayed for randomization.
739996|NCT01176513||25 subjects were enrolled in this study and 3 subjects withdrew prior to dosing with this product. As a result, 22 subjects were used in the analysis for this study.
739997|NCT01176448|Adult patients aged 18 and older were recruited from a reconstructive surgical practice. Preference was given to patients who had undergone interpolated axial flaps (e.g., forehead flaps) because this allowed treatment of two different scars on a single patient.|
739998|NCT01176435||
739999|NCT01176292|Subject enrollment began August 2007 and ended April 2009, with a total of 142 patients enrolled at an orthopaedic clinic.|
740000|NCT01176266|The main criteria for inclusion in the study were male and female patients less than or equal to 5 years of age with a documented diagnosis of infantile onset hypophosphatasia (HPP) who were otherwise medically stable. Patients must have had onset of HPP signs/symptoms prior to 6 months of age.|
740001|NCT01176240||"Post-randomization, up to 2 weeks dose titration followed by 8 wks at optimal dose.
~The first 51 patients enrolled in the study were analyzed as a separate group in an interim analysis (Study 306A).
~The final 171 patients remained blinded until the end of the study and analyzed as a separate study (Study 306B)."
740002|NCT01176058||
740003|NCT01176032||
740004|NCT01175980||
740005|NCT01175902|Seoul St. Mary's Hospital From April, 5th, 2011 to October, 16th, 2014|44 enrolled, 44 completed
740006|NCT01175850||The IN.PACT SFA Trial was designed as a two-phase randomized trial. IN.PACT SFA I, the first phase was conducted in Europe with 150 subjects enrolled. IN.PACT SFA II, the second phase, was conducted in the US with 181 subjects enrolled. The data from both phases of the IN.PACT SFA Trial have been pooled and comprise the pivotal trial data.
740007|NCT01175824||
740008|NCT01175811||
740009|NCT01175798||
740010|NCT01175707||
740011|NCT01175668|The study was conducted at Baystate Children's Hospital Davis Neonatal Intensive Care Unit (NICU), a level III, regional perinatal referral center, for Western Massachusetts, from June 2010 to June 2012|Overall 82 infants were consented for the study but 14 were excluded either because they did not have continued high modified Finnegan Scores (n=13), or had Unstable clinical status (n=1)
740012|NCT01175590|First participant entered the study 6/22/2010 and the last participant visit was 12/12/2011. Twenty four sites in the United States participated in the study.|518 participants with a clinical diagnosis of bacterial conjunctivitis were enrolled in the study, 496 completed the study; 518 participants were in Intent-to-Treat (ITT) population, 514 participants were in Safety population, and 299 participants were in modified Intent-to-Treat (mITT) population (Participants with positive culture at baseline).
740013|NCT01175473|The study was conducted at 7 centers in Germany between August 03, 2010 and November 18, 2010.|A total of 259 patients were screened of which 111 (42.9%) were screen failures. A total of 148 patients were randomized.
740014|NCT01175434||
740015|NCT01175395|Patients were recruited from Sept 2010 to January 2012.|
740016|NCT01175382|Protocol Open to Accrual: July 2010, Primary Completion Date: July 2015 and Study Completion Date: July 2015. Recruitment location: University of Alabama at Birmingham.|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form, or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis)
740020|NCT01175317|Inclusion period: july 2010 - october 2013 at single University Hospital: Maastricht University Medical Center.|Patient inclusion rate was lower than expected. Main reason was unwillingness to participate, as extra nasal probes would remain in situ after surgery.
740021|NCT01175226||
740022|NCT01175213|Recruitment was conducted 11 clinical sites in the United States.|66 participants who enrolled from study 160603 were screened and all were enrolled on the study. Of these, 3 participants were treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only i.e. did not receive rHuPH20 during this study.
740023|NCT01175148||
740024|NCT01175135||Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 2 days during the placebo lead-in phase (before randomization in the study).
740025|NCT01175083||
740026|NCT01175031||
740027|NCT01175018||
740028|NCT01175005||
740029|NCT01174823||
740030|NCT01174784|Subjects were recruited/enrolled in the study starting on August 31, 2010. 88 subjects were enrolled and exited the study by April 11, 2011. Angiographic review after the case revealed that 4 of the 88 cases did not meet the inclusion criteria and were considered screen failures per the protocol and excluded from the efficacy analyses.|
740031|NCT01174576|February-Mai 2009, Athens region, voluntarily recruitment|
740032|NCT01174563||A total of 60 participants were enrolled in the study from 12 centers across Israel.
740033|NCT01174550||
740034|NCT01174459||
740035|NCT01174446|Enrollment was conducted at 29 clinical sites in South America, Europe, and Japan.|"86 enrolled. 1 withdrew consent prior to randomization.
~31 were enrolled and randomized in Parts 1-3. Prior to receiving study drug: 3 discontinued by participant.
~Part 2 an additional 54 were enrolled. Prior to receiving study drug: 3 discontinued by participant, 1 withdrew due to an AE, 2 screen failures, and 3 withdrew due to site closure."
740036|NCT01174368||
740037|NCT01174342|Healthy pregnant women candidates for vaginal delivery were recruited at their acceptance to the delivery room, between August 2010 and August 2012, in a single center (Meir medical center).|No relevant pre-assignment details exist.
740038|NCT01174264||
740039|NCT01174238||40 patients were consented; two participants were lost to follow-up prior to treatment and hence were not included in any analyses
740040|NCT01174186|SpA patients eligible for anti-TNF treatment as described by ASAS guidelines were included from outpatient clinics in Northern Jutland, Denmark. Patients were included over a 2 years and three months time span|Patient on current non-steroidal anti-inflammatory (NSAID) treatment were subjected to a 4 week long wash-out period, because NSAID can cause falsely elevated fecal calprotectin levels
740041|NCT01174173||
740042|NCT01174160||
740043|NCT01174082||
740044|NCT01174043|This protocol was based on getting 14 patients. Due to the lack of response, the study was stopped at 11 patients for this pilot study.|
740045|NCT01174030||
740046|NCT01174004||
740047|NCT01173874||
740048|NCT01173848||
740049|NCT01173718||
740050|NCT01173679||
740051|NCT01173653|A total of 199 subjects were recruited during June and July 2010. 90 subjects were randomized to the intervention arm and 109 were randomized to the control arm.|The targeted patient population were patients presenting to the emergency department who were smokers. There were no restrictions placed on gender, race, or ethnicity.
740052|NCT01173601||The first 3 weeks was a double-blind adjunctive placebo lead-in Confirmation Phase during which participants continued their SSRI with adjunctive placebo. If randomization criteria were met, participants were randomized to receive LY2216684 12 mg, 18 mg, or placebo. If criteria were not met, participants continued on placebo to maintain the blind.
740053|NCT01173523|Patients enrolled from July 2010 through March 2013.|
740054|NCT01173471|This multicenter study was conducted in 19 centers in the US, UK, and Sweden between 13 December 2010 and 06 November 2012. A total of 117 patients were screened in the study and of these, 50 were randomized into the double-blind treatment period.|Diagnosis of intra-ocular hypertension (raised IOP), or POAG, with IOP >20 mmHg and =<36 mmHg, and currently prescribed a stable dose of one anti-glaucoma medication that began at least 30 days prior to the screening visit or a diagnosis of intra-ocular hypertension, defined as an IOP >22 mmHg and =<36 mmHg while not on anti-glaucoma medication.
740055|NCT01173211|Participants were healthy pregnant women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 28Sep2010 and 27Apr2011|
740056|NCT01173159||
740057|NCT01173120||
740058|NCT01173055||Participants enrolled in the study received placebo for 1 week (Day -7 to 0) then began the double blinded treatment sequence.
740059|NCT01173029|Recruitment was carried out in outpatient clinics at Instituto Nacional de Cardiologia.|Participants who have been diagnosed as secondary hypertension were excluded from the trial before assignment to resistant and pseudo-resistant groups.
740060|NCT01173016||
740061|NCT01172938|This study was a multicenter study with 83 study sites from the US, Canada, Europe, Russia, Australia, New Zealand and South Africa.|The study population was restricted to male and female subjects ≥ 18 years of age with moderate to severe Psoriatic Arthritis (PsA). Participants must have had a diagnosis of PsA by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria, including peripheral joint involvement.
740062|NCT01172873|Recruitment was drawn from the broadest possible population with respect to gender and ethnic origin. Internal Review Board(IRB)-approved web/radio/newspaper ads & flyers were used to recruit patients, as were physician and mental health practitioner referrals.|16 adolescents(12-17yrs) participated in the study. The initial 11 participants received 10 twice-weekly sessions of exposure and response prevention treatment (E/RP) as well as D-Cycloserine(DCS) 50mg at each session. The final 5 participants received 10 twice-weekly sessions of E/RP treatment alone during the active study period.
740063|NCT01172847|This study was conducted at a single center in the United States from 04 August 2009 to 28 September 2009. A total of 40 participants were screened.|Of 40 participants, 24 participants were enrolled.
740066|NCT01172639|We recruited 400 participants between January 2009 and May 2013. There were 13 participating Flemish rheumatology centers (2 academic centers, 7 general hospitals and 4 private practices).|There were 379 patients randomised to a treatment arm, 21 patients not randomised: 1 screen failure, 10 withdrawals by subject, 10 randomisation errors
740067|NCT01172600||
740068|NCT01172535|There were 97 participants enrolled from 19 clinical sites in four countries. There were 57 participants on the liquid formulation and 40 on tablet. Accrual took place from May 20, 2011 through June 19, 2013.|HIV-infected infants and children ≥3 to <25 kg had to be LPV/r-treatment naïve. Children ≥10 kg had to demonstrate ability and willingness to swallow tablets. Participants were stratified by weight and drug formulation (liquid vs. tablet).
740069|NCT01172522||
740070|NCT01172418||
740071|NCT01172353||
740072|NCT01172288||
740073|NCT01172275||
740074|NCT01172197|Patients recruited on ward 24h before procedure. Patient information sheet sent to patients 3 weeks before operation|Nil to report
740075|NCT01172184|The present study enrolled 111 patients with severe mitral regurgitation (MR) who had undergone cardiac catheterization in Kaohsiung veterans general hospital.|
740076|NCT01172145|Participants were recruited from a Memory Disorders Clinic and the community between 2005 and 2007|
740077|NCT01172067||
740078|NCT01171989||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
740079|NCT01171976|A total of 373 patients with macular edema and visual impairment secondary to DME were enrolled. A total of 372 patients were randomized. One patient was excluded from all analyses due to administrative problems|Antimicrobial eye drops were dispensed at each study visit (PRN ranibizumab) or at visits with scheduled injections (TE ranibizumab + laser or TE ranibizumab alone).
740080|NCT01171963|Duration of the study was of a maximum of 21 months, with the enrolment of subjects starting in August 2010, and subjects being followed up to May 2012 (study Month 21 and Study End), end of the rotavirus season in China.|Subjects were assigned to 2 sub-cohorts (1:1 ratio). Sub-cohort 1 and Sub-cohort 2 subjects received their OPV and Infanrix™ EPI vaccination respectively independently of, and concomitantly with their Rotarix™/placebo vaccination. 3340 subjects were allocated study subject number allocated and 3333 vaccinated .
740081|NCT01171924||
740082|NCT01171898||
740083|NCT01171820|324 subjects were recruited at 32 sites. Eligible subjects invited to participate, in-hospital or in-clinic and required to provide signed informed consent prior to enrollment. Final eligibility based on angiographic inclusion criteria prior to the intended procedure. Dates of recruitment: April 28, 2007 to October 6, 2008.|Subjects were randomized via telephone randomization and stratified by insulin treatment status, number of lesions treated-single vs. multiple. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.
740084|NCT01171794||
740085|NCT01171690|Patients recruited between 1/1/2010 and 1/12/2013; all patients were recruited at Mayo Hospitals in Rochester, Minnesota, USA. The controls were recruited from the pool of patients with similar degree of hypoparathyroidism postoperatively but previously to the initiation of the trial.|
740086|NCT01171677|40 Subjects consented, 4 discontinued prior to completing screening, 36 completed baseline, 4 were ineligible, 32 were randomized.|
740087|NCT01171625||
740088|NCT01171612|Observational, multicenter and prospective study, approved by the Ethics Committee. All patients with coronary stents undergoing noncardiac surgery with admission from February 2010 to April 2012 were the basis of the study.|Patients scheduled for noncardiac surgery with admission
740089|NCT01171534||
740090|NCT01171521||
740091|NCT01171183||
740092|NCT01171118|Dates of recruitment August 2009 to December 2010. Subjects were recruited from advertisements.|Subjects excluded from trial before assignment to group because BMI to high, medication exclusions, lost of follow up, scheduling conflict.
740093|NCT01170962|Participants were enrolled at 69 sites in 11 countries.|A total of 512 participants were enrolled and 421 participants were randomized (2 randomized participants were not treated: 1 due to positive pregnancy test and 1 no longer met criteria). Remaining 91 participants were not randomized as; 73 no longer met study criteria, 15 withdrew consent, 1 due to administrative reason and 2 for other reasons.
740094|NCT01170949||
740095|NCT01170884||
740096|NCT01170754||
740097|NCT01170663||Completers include participants that discontinued study drugs either due to progressive disease (PD), due to an adverse event or died due to any cause, but not necessarily had any survival-FU assessment done.
740098|NCT01170598|This non-randomized phase II study recruited patients between June 2010 and February 2011. All participants were recruited from Princess Margaret Hospital (PMH) in Toronto, Canada.|
740099|NCT01170546|Knee joint laxity was surveyed by a KT-2000 test during 2006, Feb and 2006, March. The anterior drawer laxity of the knee joint was defined as anterior displacement over 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force.|One hundred and seventy-three students were tested and 30 met the criterion, including 22 males and 8 females. Two males were excluded due to other causes that might affect muscle strength or knee stability such as lower limbs fracture and arthritis. Besides, eight female students were eliminated to avoid possible gender difference.
740100|NCT01170533||The proposed study will have a prospective, randomized, cross-over design.
740101|NCT01170390|A prospective cohort study was conducted at the Oregon Health & Science University (OHSU) in Portland, OR, from March 2006 to September 2007. Recruitment included print ads in local newspapers, flyers posted in the Center for Women's Health & other OHSU clinics and public places, and electronic postings to web sites such as Craig's List.|
740102|NCT01170364|45 potential participants were screened for eligibility between February, 2009 and July 2010 at an academic medical center in New York City, NY.|14 of 45 patients were randomized. Of those not randomized, 21 did not meet inclusion criteria.
740103|NCT01170273||
740104|NCT01170247|6 months|
740105|NCT01170221||
740106|NCT01170208|July 2010 to October 2010. Location: Medical Clinic|
740107|NCT01170117|Recruitment took place from December 2010 through June 2016 at each of the five study sites, which are medical clinics: Columbia University-New York State Psychiatric Institute, Weill Cornell Medical College, Centre For Addiction And Mental Health in Toronto, University Of Pittsburgh and Johns Hopkins University.|A total of 25 individuals across sites discontinued the trial prior to group assignment, and 17 were withdrawn by investigators before randomization. These individuals were excluded from the trial due to various reasons such desiring alternate care, and not being interested in medication.
740108|NCT01170091||
740109|NCT01170065|Treatment groups are displayed according to dose at randomisation in 1199.30 (NCT00514683).|Patients were not randomised to study medication in trial 1199.35 but were to receive open-label nintedanib, either at the dose received in period 2 of parent trial 1199.30 (NCT00514683) or they could increase their dose to nintedanib 150 mg twice daily (bid) after implementation of protocol amendment 1.
740110|NCT01170039|Subjects were recruited from The Emory Clinic and The Atlanta Veterans Administration Hospital from August 2011 to September 2014.|121 subjects were enrolled in the study; there were 4 Screen Failures, 22 drop outs prior to randomization and 19 subjects were Early Terminations. 76 subjects were randomized and underwent a two-week wash-out period during which they did not take any laxatives.
740111|NCT01169987||
740112|NCT01169779|The study was conducted at 35 centers in 4 countries between July 21, 2010 and December 22, 2011.|A total of 655 patients were screened of which 264 (40.3%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 391 patients were randomized.
740113|NCT01169753|Recruitment Period: May 12, 2011 to December 4, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Study terminated early due to slow accrual.
740114|NCT01169701||
740115|NCT01169675||
740116|NCT01169649||
740117|NCT01169610|Recruitment period 1/2011 - 9/2012|
740118|NCT01169558||168 participants were enrolled in the study of which 162 received at least one dose of study drug. Only those who received at least one dose of study medication were included in the Intent to Treat (ITT) population, which is the population reported.
740119|NCT01169519|Patients recruited upon presentation for elective Pre-stage II or stage III catheterization. The first patient was recruited on 4/14/2011 and the final patient was enrolled on 11/29/2012|Enrolled subjects were excluded from trial participation if they demonstrated baseline hemodynamics suggesting that they would not tolerate sildenafil infusion (e.g. baseline hypotension)
740120|NCT01169493||
740121|NCT01169467|89 subject signed consent, 5 subjects screen failed.|
740122|NCT01169350||
740123|NCT01169311|Between 21 July 2010 and 17 March 2011 patients were recruited at 2 medical clinic and one hospital; subjects with grades 2-4 hemorrhoids eligible for stapled hemorroidopexy were assessed for eligibility for study; exclusion criteria: pregnant,Ab use for SSI, drug/alcohol abuse, aspirin/anticuagulant therapy, hx VT, hx PE,|
740124|NCT01169259|401605 initially screened; 39430 eligible to enter run-in; 25871 eligible for randomization; 2x2 factorial design: 12927 assigned to active vit D (of these, 6463 were assigned to active omega-3 FAs and 6464 to placebo omega-3 FAs) & 12944 assigned to placebo vit D (of these, 6470 were assigned to active omega-3 FAs and 6474 to placebo omega-3 FAs)|The trial included a 3-month placebo run-in period to select participants likely to have excellent compliance. Only individuals who reported taking at least 2/3 of their study pills during the run-in and met other eligibility criteria were randomized into the trial.
740125|NCT01169103|Participants were recruited at Massachusetts General Hospital between September 2010 and October 2012 through area pediatric and obesity clinics and advertisements.|Of the 32 subjects who were screened, 22 were eligible & randomized. 5 subjects were ineligible due to Insulin Like Growth Factor levels above the eligibility limit for pubertal stage or age. 2 were excluded due to planned initiation of medications that were on the exclusion criteria list and 3 voluntarily withdrew consent prior to randomization.
740126|NCT01169064||31 patients were removed from the study after consent but prior to study start, these participants did not meet inclusion / exclusion criteria
740127|NCT01169038|Participants were recruited from outpatient pulmonary clinics at Vanderbilt University Medical Center and the surrounding community between July 14 and August 24, 2010. All patients met American Thoracic Society/European Respiratory Society/World Association of Sarcoidosis and Other Granulomatous Diseases (ATS/ERS/WASOG) criteria.|
740128|NCT01168999|The study was undertaken in a lab on the University of Florida. Participants were recruited through written and electronic advertisement approved by the University of Florida Institutional Review Board. The first participant was enrolled in the study in November of 2009 and the final participant completed the study in January of 2013.|
740129|NCT01168986||
740130|NCT01168973||Participants who died, due to any cause, or were alive at the end of the study but off study drug were considered to have completed the study.
740131|NCT01168934||
740132|NCT01168908||
740133|NCT01168856|Participants from following studies were enrolled: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094].|"This study was terminated early and participants discontinued due to study termination were included under reason unspecified in the participant flow."
740134|NCT01168726||
740135|NCT01168687|Recruitment was conducted online (Craigslist) and from publicly posted flyers.|Enrolled participants were excluded prior to medication dosing if blood testing revealed elevated liver enzymes or if urine testing indicated a pregnancy.
740136|NCT01168674||
740137|NCT01168596||
740138|NCT01168427||
740139|NCT01168401|Participants took part in the study at 3 investigative sites in the United States from 03 September 2010 to 09 January 2013.|Healthy volunteers were enrolled in 1 of the following treatment groups: Bivalent Norovirus GI.1/GII.4 Vaccine (Cohort A: 5/5 microgram [mcg], 15/15 mcg, 50/50 mcg, 150/150 mcg; Cohort B: 50/50 mcg; Cohort C: 50/50 mcg and Cohort D: 50/50 mcg) adjuvanted with 50 mcg monophosphoryl lipid A (MPL) and 500 mcg aluminum hydroxide [Al(OH)3]) or Placebo.
740140|NCT01168349||
740145|NCT01167881||An optional 2-year extension was implemented in this trial through a protocol amendment, which brought the total length of treatment to 4 years. However, some sites did not participate in the 2-year extension, and so considered patients to have completed treatment after 2 years.
740146|NCT01167829|Subjects were recruited through news media (website)and college campus bulletin boards in Seattle, WA. between July-September 2010. All visits were at the University of Washington, Seattle, WA.|14 subjects were screened and 2 did not meet inclusion criteria for untreated high blood pressure and peripheral arterial disease.
740147|NCT01167712|Newly diagnosed women with high-risk early stage or advanced stage epithelial ovarian cancer enrolled from September 27, 2010 to February 8, 2012.These women were randomly assigned to receive either carboplatin (AUC 6) combined with either paclitaxel 175 mg/m2 q 21 days or paclitaxel 80mg/m2 on days 1, 8 and 15. Bevacizumab was optional.|112 additional women, whose treatment was not randomized, enrolled onto this study in order to evaluate whether findings from perfusion imaging are prognostic. This report focuses on the randomized treatment component of this study.
740148|NCT01167634||
740149|NCT01167608|People with Parkinson's disease throughout the United States (US) were recruited from several sources (i.e., support groups affiliated with the American Parkinson's disease Association; internet sites such as the Michael J. Fox Foundation Fox Trial Finder Wedsite). Recruitment took place between June of 2010 and February of 2012.|
740150|NCT01167582||
740151|NCT01167569|Subjects were recruited from Oct. 31, 2007 thru July 22, 2009 in the Cardiothoracic Surgery Clinic.|
740152|NCT01167504|Recruitment took place between 16/6/2010 and 16/2/2012. A pool of 12 volunteers was required. 12 volunteers were recruited in 2010 and 2011, 3 further volunteers recruited in 2012 to replace 3 volunteers who left the study for personal reasons.|There were no significant events required following enrollment.
740153|NCT01167452||
740154|NCT01167426||
740155|NCT01167257||
740156|NCT01167192|The study opened to enrollment on 02/04/2011 and closed to enrollment on 09/10/2013.|
740157|NCT01167179|Recruitment period: November 2007 to February 2010. Setting: outpatient oncology clinic|The eligibility criteria for the study were as follows: informed of a HNC diagnosis (but no other cancer); to be treated with curative intent; to be able to speak, write and understand Dutch; and be cognitively able to provide informed consent. Exclusion criteria included overt psychopathology, alcohol addiction, life expectancy of less than 6 mo.
740158|NCT01167153||
740159|NCT01167140||
740160|NCT01167023||
740161|NCT01166997|Multi-center, Phase III study at 8 tertiary care hospitals in Germany and Switzerland|Acute symptomatic PE confirmed by contrast-enhanced computed tomography (CT) with embolus located in at least 1 main or proximal lower lobe pulmonary artery RV to left ventricular dimension (RV/LV) ratio ≥1 obtained from the echocardiographic apical 4-chamber view
740162|NCT01166971|Bilateral diagnosis of cataracts of subjects >21 years of age|During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
740163|NCT01166958||
740164|NCT01166945||A total of 98 subjects were consented and enrolled. A total of 82 subjects completed the study through day 30. Participants were evaluated on days 5, 10, 15, and 20 for the primary outcome.
740165|NCT01166763|Recruitment April 2009 to December 2010. Breast Cancer Prevetnion Center at University of Kansas Medical Center|
740166|NCT01166750|Dates of recruitment were from April 2009 to May 2011.|Twelve subjects were not randomized to groups, 2 due to infrequent pain, 2 moved or phone was disconnected, 6 would not return phone calls, and 2 dropped out as they were too busy.
740167|NCT01166724||
740168|NCT01166659|Participants were enrolled at 7 investigational sites in Germany, Bulgaria, Spain and Austria.|This reporting group includes all treated participants.
740169|NCT01166646|"Recruitment period: August 2010 to May 2011
~The location of clinical sites included private dermatology clinics and clinical research centers."|All subjects who met the entry criteria were randomized and enrolled into the study.
740170|NCT01166568|The prospective, multicenter clinical trial of the PresView Implant was conducted at 14 clinical sites. All recruitment evaluations were performed at the Principal Investigator's sites and subjects were screened for eligibility. If inclusion/exclusion criteria were met, informed consent was obtained and the subject was enrolled in the study.|Once determined eligible and informed consent was obtained, both eyes were enrolled in the study. Per protocol, primary outcome analysis must be performed on the primary eye only and the primary eye is therefore the unit of analysis. Fellow eyes were followed for safety outcomes and summarized separately.
740171|NCT01166438||
740172|NCT01166373|The goal of the video/no video intervention was to gauge differences in recruitment for and retention in E-OPTIMAL, thus the video/no video randomization occurred before E-OPTIMAL consent.|Treatment groups are from the original OPTIMAL trial. Participants in the E-OPTIMAL trial were recruited from OPTIMAL participants that completed the Year 2 OPTIMAL visit.
740173|NCT01166347||Five enrolled subjects were not randomized to a group due to lack of written insurance approval to receive the study device, death prior to randomization, prior screen failure (later improved), or withdrawal of consent.
740174|NCT01166282|The study included a 30-day screening period.|
740175|NCT01166230||
740176|NCT01166178|168 participants were planned to be randomized. 29 participants were randomized in a 2:1 ratio (zoledronic acid : placebo); no participants completed the study. One participant withdrew consent and the study was terminated.|
740177|NCT01166139||
740178|NCT01166126|Up to 35 subjects with a histologic diagnosis of unresectable Stage IV melanoma were to be enrolled into this study over 24 months.|11 of 15 patients consented were not eligible to receive the study drug after screening.
740179|NCT01165996|Patients were recruited from medical clinic between July 2010 and September 2011.|
740180|NCT01165983||A total of 124 subjects signed the ICF, but after screening procedures, 24 were found ineligible so only 100 were randomized to placebo or Aliskiren.
740181|NCT01165840|Patients were recruited into three BMI groups to ensure a wide total body weight distribution, but only one pharmacokinetic model was analyzed with total body weight being one of the potential covariates that was assessed.|Thirty-seven patient provided consent, but only 36 started the study. One patient provided informed consent but was found to have G6PD and was not allowed to continue.
740182|NCT01165775|Women receiving clinically indicated betamethasone between 24 and 34 weeks of pregnancy were recruited from the labor and delivery setting.|
740183|NCT01165684|The trial was conducted at 69 sites in 7 countries: Argentina (7), Brazil (5), Canada (12), France (7), Macedonia (1), Slovenia (4), and the US (31). Of 12 sites in Canada, one site (Site 303) closed early on 07-Mar-2011.|Subjects on pre-trial metformin and pioglitazone continued their medication.
740184|NCT01165554|Study started on May, 2010 and ended on November 2011.|23 subjects withdrew from study prior to dosing of the product.
740185|NCT01165541||
740186|NCT01165450||3 patients were enrolled but only 2 randomized. The third patient was withdrawn from the trial before randomization because we were notified that the study drug had expired and was no longer available.
740187|NCT01165424||
740188|NCT01165320|Participants with documented esophageal candidiasis, invasive candidiasis, or aspergillosis and who met all of the additional inclusion and exclusion criteria were to be enrolled in the study|Three participants were initially enrolled but were withdrawn when their suspected fungal infections were not confirmed. These 3 participants did not receive study drug. No participants with esophageal candidiasis were identified for inclusion in the study.
740189|NCT01165307|Subjects were recruited at Mayo Clinic in Rochester, Minnesota from September 2009 to February 2013.|77 subjects were initially consented, but 10 subjects were not randomized because 4 declined participation after consent, 4 reported spontaneous improvement during initial evaluation, 1 had an abnormal Pap smear indicating treatment, and 1 had a polypoid mass on hysteroscopy.
740190|NCT01165281|To evaluate the safety and efficacy of tapentadol ER compared with oxycodone CR in Japanese and Korean patients with moderate to severe chronic cancer pain. This study was conducted from 25 Aug 2010 to 16 Aug 2012 at 69 sites in Japan and Korea. A total of 340 patients received at least 1 dose of study drug and were included in the safety analyses.|
740191|NCT01165242||Out of the 1013 subjects enrolled in this study, 2 were assigned subject numbers but received no vaccination and were hence excluded from the study start.
740192|NCT01165229||Only 13900 subjects from the total enrolled number were vaccinated and included in the Total Vaccinated Cohort. In the placebo group,1 subject had an unknown withdrawal status before the study site closure. This was not identified during database freeze, leading to 1190 subjects in place of 1189 that actually completed the placebo group
740193|NCT01165216||Participants were enrolled in successive cohorts of 3 to 6 patients, using a standard 3+3 design. Of 15 patients enrolled, all received some treatment (chemotherapy or ipilimumab); 12 received at least 1 dose of ipilimumab.
740194|NCT01165203||
740195|NCT01165177||Out of all the subjects enrolled into this study, only 15405 received vaccination and were hence considered to start the study.
740196|NCT01165138||Participants meeting eligibility criteria at the Screening visit completed a 4-week Run-in Period for Baseline safety evaluations and measures of asthma status. Participants were then randomized to a 12-week Treatment Period. 1110 participants were screened, 610 were randomized, and 609 received >=1 dose of study treatment.
740197|NCT01165112||
740198|NCT01165047||
740199|NCT01165021||Participant Flow reports participants who discontinued from study treatment. Completed participants were those who had a baseline tumor assessment, finished 3 cycles (Cy) of pre-operative chemotherapy (chemo), and had a second tumor assessment following chemo.
740200|NCT01164956|3 participants were enrolled between July 2011 and January 2012. Only the arms of these participants are presented.|
740201|NCT01164891||
740202|NCT01164865|Participants were recruited from two US study centers.|
740203|NCT01164722||
740204|NCT01164644|Adult patients scheduled for rhinoplasty surgery with nasal bone osteotomies by the senior author at an outpatient surgery center were recruited by a clinic nurse practitioner (GJ) during the routine pre-operative history and physical exam visit. Enrollment was opened from July of 2009 through June of 2012.|28 subjects were recruited, 22 completed the study. One elected to leave the study prior to surgery, 2 attended only one post-operative visit; 2 did not undergo surgery (loss of health insurance [1] and thrombocytopenia [1]); and 1 subject elected to leave the study for laser treatments for ecchymosis on post-operative day 3
740205|NCT01164579||
740206|NCT01164501||
740207|NCT01164475|The study was conducted at 7 centers in 4 countries between October 13, 2010 and February 26, 2013.|A total of 71 patients were screened of which 10 patients were screen failures. A total of 61 patients were randomized.
740208|NCT01164137|Recruitment period began November 1, 2008 and ended June 30, 2010.|Three participants were excluded from the trail before assignment to groups because they obtained a score of 19 or less on the Mini Mental State Examination (MMSE).
740209|NCT01164098||
740210|NCT01164007||
740211|NCT01163955|Random recruitment at a Best Buy store. Flip of a coin decided the sitting position for the test|Some children were excluded from the final results because they sat on their glut max and kneeled alternating throughout the test.
740212|NCT01163916||
740213|NCT01163851||
740214|NCT01163786|The study opened for accrual on July 20, 2010 with an accrual goal of up to 20 evaluable patients. The first patient being enrolled on the study on October 7th 2010. The study was closed permanently on August 31 2015 before the accrual goal was met with 17 patients being treated on study.|Patients were diagnosed with pulmonary Chronic Graft Verses Host Disease (p-CGVHD) after having undergone allogeneic hematopoietic stem cell transplant (HSCT). Patients were required to be less than 100 days post HSCT, with an absolute decrease of 12% or more in forced expiratory volume in 1 second (FEV1) from pre-transplant baseline.
740215|NCT01163760|There were 50 subjects enrolled in this single site study, located at Singapore University.|There were 50 patients enrolled and randomized, and 50 patients completed the study.
740216|NCT01163747||This study was conducted at 35 centers in the United States. Among the 112 patients screened, 91 patients were randomized in a 1:2 ratio to the methotrexate alone or to the tocilizumab + methotrexate treatment group.
740250|NCT01162005|"From July 2010 to August 2013, children with refractory NS were enrolled.
~It was conducted at three centers in Korea after obtainment of informed consent.
~( Seoul National University Children's Hospital, Samsung Medical Center, Asan Medical Center Children's Hospital)"|
740217|NCT01163721|Participants with type 2 diabetes mellitus (T2DM) were enrolled in a total of 9 study sites in the United States. The first participant was screened on 22 June 2010. The last participant observation was on 15 November 2010.|The Safety Analysis Set (n = 80) includes participants who were randomized in the study and received at least one dose of study drug. The Full Analysis Set (n = 79) includes participants who were randomized in the study and received at least one dose of study drug, and had at least one post-baseline efficacy measurement.
740218|NCT01163656|Healthy infants under the age of 12 months undergoing elective surgery requiring tracheal intubation were eligible.|Any subject was excluded from participation if they were known or suspected to be a difficult intubation or if they required a rapid-sequence intubation.
740219|NCT01163643||
740220|NCT01163617||One participant withdrew after Phase A and was replaced with a new participant prior to Phase B. Participants were re-randomized for Phase B.
740221|NCT01163604|The present study was a single-center, open-label, prospective, randomized, controlled pilot one. Enrollment of participants began in August 2010, and completed in August 2011. The local ethics committee approved the study, and written informed consent was obtained in all recruited patients.|The present study was a single-center, open-label, prospective, randomized, controlled pilot one. Enrollment of participants began in August 2010, and completed in August 2011. The local ethics committee approved the study, and written informed consent was obtained in all recruited patients.
740222|NCT01163474|Patients were recruited after coronary artery bypass or cardiac valvular surgery.|All participants were assigned to both the intervention (post-surgical evaluation by video-teleconference) and control (face-to-face visit) groups.
740223|NCT01163461||
740224|NCT01163318||The primary reason for discontinuation was not collected for 224 participants listed under the category of 'multiple reasons per participant' (Insufficient effect (n=76), other reasons (n=43), economic reasons (n=2), AEs (n=41), no further visits (including change of hospital) (n=39), discontinued by the patient request (n=17), and unknown (n=8)).
740225|NCT01163292||
740226|NCT01163279|Participants were recruited from a research subject pool and a community psycho-education program at Baycrest.|A total of 96 participants were assessed for study eligibility. 60 participants were excluded after a phone screening interview and 17 were excluded after a more detailed baseline assessment which included cognitive paper and pencil tasks. The remaining 19 participants were randomized to either the experimental arm or the control arm.
740227|NCT01163266|Participants took part in the study at 37 investigative sites in the United States from 15 July 2010 to 17 January 2012.|Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 3 treatment groups, once a day placebo, 10 mg, or 20 mg vortioxetine.
740228|NCT01163253||A total of 2881 participants were enrolled in this study, however 2867 participants received treatment.
740229|NCT01163214|Subjects were recruited from Mayo Clinic, Phoenix, Arizona from September 2010 to February 2013.|
740230|NCT01163162||
740231|NCT01163149||
740232|NCT01163097|This open-label, randomized, parallel-design, Phase I study in healthy adult subjects was performed in 1 center (New Orleans Center for Clinical Research, Knoxville, TN, USA) between July and December 2010.|Subjects randomized to receive palifermin in combination with heparin did first enter a titration period where they received titrated heparin doses to achieve an aPTT of 1.5 to 2.0 × baseline. Subjects who could not be successfully titrated within the heparin titration period were discontinued, and did not enter the palifermin treatment period.
740233|NCT01163084|Participants were recruited by physicians in the Genitourinary Medical Oncology Clinic and Urology clinic.|10 participants started but only 9 were randomized
740234|NCT01163032|*Various category for the Randomization Phase: 4 patients in each treatment group discontinued due to study termination by the sponsor and 1 patient in the tasimelteon group discontinued due to travel across multiple time zones|
740235|NCT01162863||60 adults were screened of whom 4 were screen failures.Of the 56 remaining study participants, 2 were unable to swallow the wireless motility capsule and 2 more dropped out of the study prior to randomization yielding 52 randomized participants.
740236|NCT01162733||
740237|NCT01162551||
740238|NCT01162499|Children were recruited from the Division of Endocrinology and Diabetes at The Children's Hospital of Philadelphia.|One subject signed consent but they were excluded from study participation after the study team was unable to establish IV access.
740239|NCT01162486||
740240|NCT01162473|Children with a history of cow's milk allergy were referred from CHOP Allergy Clinics located in the main campus and satellite offices. Allergy and general pediatric practices in the greater Philadelphia area were also contacted by study staff as part of enrollment outreach.|
740241|NCT01162421||
740242|NCT01162382||
740243|NCT01162343|While 498 patients were enrolled, 92 were excluded from the final analysis because they did not receive a psychiatrist reference standard delirium assessment. As a result, 406 patients were included for the final analysis.|
740244|NCT01162317||
740245|NCT01162304|1-20-2010 to 11-21-2013 at the medical center.|Study was terminated participants were enrolled but treatment arm assigment was not shared with the study team.The study team was blinded and research pharmacy which was tracking randomization destroyed study records before sharing with the study team.
740246|NCT01162239|Participants were recruited from University of California, San Francisco medical clinics and the general community. Participants from the general community were recruited through flyers posted at various community health care organizations and social service agencies. Advertisements were placed in local newspapers and websites.|Participants were stratified based on gender, age, site, and number of cigarettes smoked per day at baseline. Participants were then randomly assigned to one of four treatment conditions derived from a double blinded allocation list prepared by a statistician. Neither participant nor the therapist were unblinded to final treatment until Week 8.
740247|NCT01162135||
740248|NCT01162122|Subjects were enrolled from 4 sites in Columbia, 2 sites in Panama, 11 sites in Philippines, 21 sites in USA.|Five enrolled subjects were not randomized and did not receive study vaccination, hence were discontinued.
740249|NCT01162096||
740820|NCT01130740|Primary care providers in the Durham VA Ambulatory Care Service and their patients were recrutied from this study. Recruitment began on August 4, 2011 and was completed on December 30, 2012.|
740251|NCT01161862|Twelve adult and twelve pediatric subjects with type 1 diabetes and no endogenous insulin secretion participated in two 51-h experiments. The protocol was approved by the Massachusetts General Hospital (MGH) and Boston University Human Research Committees|
740252|NCT01161771||
740253|NCT01161628||
740254|NCT01161563||
740255|NCT01161537|Study was initiated on October 10, 2010 after first eligible subject signed informed consent form and enrolled in study.|All results were planned to be reported separately for Part A and Part B of the study.
740256|NCT01161524||Of the 154 participants screened for entry into the Core Study, 21 were screen failures and 133 were randomized and treated. A total of 119 participants completed the Core Study, and 114 participants entered the Extension Phase.
740257|NCT01161498|This study was open to patients with advanced, non-metastatic, stage III or IV squamous cell carcinoma of the head and neck (SCCHN).|
740258|NCT01161472||
740259|NCT01161446||
740260|NCT01161420|Between 10 Nov 2010 and 15 Feb 2012, 25 clinical sites enrolled 929 subjects into the study. A total of 803 subjects were withdrawn from the study as they were not eligible and did not receive an implant.126 subjects from 22 clinical sites were implanted the UAS system (3 clinical sites enrolled subjects but did not attempt or implant a device).|126 subjects were implanted with the Inspire therapy. At 12 months, the first 46 therapy responders were randomized 1:1 to either therapy ON (maintenance) or therapy OFF (withdrawal) for one week. Those who were in the withdrawal group returned to full therapy after one week of therapy being turned off.
740261|NCT01161407||
740262|NCT01161329|A total of 195 individuals where screened for eligibility consecutively between October 2009 to April 2011.|Of the 195 eligible participants 124 were ineligible and 4 declined participation..
740263|NCT01161225||
740264|NCT01161173||
740265|NCT01161160||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
740266|NCT01161121|Patients provided written consent for participation in the study prior to cardiac catheterization. Diagnostic coronary angiography was performed utilizing standard techniques. Patients in whom the operator believed needed physiologic coronary assessment with Fractional Flow Reserve (FFR) were then eligible for participation in the study.|
740267|NCT01161043||
740268|NCT01160848|"The study was conducted in one center in the US:
~Michael Jarratt M.D. DermResearch Inc. 8140 N Mopac Building 3, Suite 120 Austin, TX 78759. First patient entered the study on the 8th of November 2010 Last patient last visit on the 9th January 2011"|
740269|NCT01160822||
740270|NCT01160770|Subjects enrolled in the LGS studies 13108A/OV1002/NCT00162981 or 13110A/OV1012/NCT00518713 sponsored by Lundbeck LLC who either completed the study or who prematurely discontinued will have the opportunity to rollover into this open-label study.|
740271|NCT01160744||Participants who died (any cause) or had disease progression were considered to be study completers.
740272|NCT01160640||
740273|NCT01160614|First Patient First Visit: 18-Aug-2010; Last Patient Last Visit: 16-Aug-2011. The study was conducted at 11 sites in the United States and Australia.|Pediatric patients who were anticipated to have pain requiring opioid analgesia.
740274|NCT01160484|This study enrolled patients from eight different clinical sites sites in the United States. Data was collected from September 2009 until July 25, 2011|
740275|NCT01160458||
740276|NCT01160445||
740277|NCT01160380||
740278|NCT01160354|Recruitment Period: August 05, 2010 to May 13, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.|Study was closed early due to slow accrual and did not continue to complete second part (Phase 2). Last cohort of Maximum Tolerated Dose (MTD) level 400 mgc/kg included two participant registrations for study continuation that did not occur.
740279|NCT01160289||The study had 2 periods. Period 1: a screening, a 4-week washout, and a 4-week lead-in period prior to randomization. Period 2: a 12-week treatment and a 4-week follow-up period, post-randomization.
740280|NCT01160237||
740281|NCT01160211|A total of 355 subjects were enrolled in the study at the time of the cut-off date for analysis. After the cutoff date (11 Mar 2016), 14 additional subjects were enrolled; however no data from these subjects are reported in this report. Analysis was done on the Intent-to-Treat (ITT) population.|The ITT comprised all randomized subjects regardless of whether or not treatment was administered. This population was based on the treatment to which the subject was randomized.
740282|NCT01160198|This study was conducted at 6 centers in India from 12-October-2010 to 17-February-2011. OROFER XT™ (ferrous ascorbate, 100 milligram [mg]) is a registered product of Emcure Pharmaceuticals Ltd., Pune and Ferronine™ (ferrous bisglycinate chelate, 60 mg) is registered product of GlaxoSmithKline.|A total of 317 participants with iron deficiency anaemia were screened for this study; of these, 270 participants were randomized. Intent-to-Treat (ITT) population: all randomized participants who received at least one dose of study medication (n=270). Before randomization, all participants were dewormed with a single tablet of 400 mg albendazole.
740283|NCT01159938||Participants with type 2 diabetes mellitus (T2DM) were randomized to either a high to low blood glucose sequence or a low to high blood glucose sequence dependent upon whether they received insulin lispro or not in the first study period. Participants were stratified into treatment arms based on their urinary albumin excretion rate (UAER).
740284|NCT01159912|One participant received treatment (placebo) but was not randomized. Thus, 350 participants were enrolled in the study; however, only 349 were randomized.|Participants (par.) meeting all inclusion criteria/no exclusion criteria during Visit 1 entered a 4-week Run-in Period (RIP). At Visit 2 (end of RIP), par. meeting the eligibility criteria were randomized to the 24-week Double blind Treatment Period. 1036 par. were screened, 349 were randomized, and 343 received >=1 dose of study treatment.
740285|NCT01159769|Patients were recruited from 12 US study centers. Eligible patients having a history of allergic conjunctivitis and treated with protocol-specified anti-allergy medications for at least 7 days within 6 months prior to Visit 1 were enrolled. Investigators reviewed files to identify patients.|215 patients were enrolled. All patients received the same treatment.
740286|NCT01159743||
742699|NCT01025271|unable to meet enrollment no data available. Study terminated early|unable to meet enrollment no data available. Study terminated early
740287|NCT01159691|This study started to enroll subjects in June 2010 in order to end up with 21 centers in Germany.|76 patients were included in the Enrolled Set (ES), 75 of whom were treated with Neupro® at least once during the Observational Period and, thus, constituted the Safety Set (SS). The Full Analysis Set (FAS) encompassed all 65 patients who had been treated with Neupro® at least once and who had valid Baseline and Follow-up Visit values.
740288|NCT01159665|The first subject was enroled on 15 Jul 2010 and the last patient completed the study opn 30 Nov 2010.|"38 subjects were enrolled into the study. However, the vitreous samples for 2 subjects were excluded from the analysis:
~The vitreous sample for Subject 101106 was contaminated during vitrectomy.
~Subject 101202 (Group 2) had a previous vitrectomy and retinal detachment in the study eye (exclusion criteria violation)."
740289|NCT01159600||
740290|NCT01159574||
740291|NCT01159535||
740292|NCT01159431|Subjects were recruited beginning at Olive View/UCLA and Keck-USC between 3/2008 and 10/2010|6-week pretreatment baseline
740293|NCT01159262||
740294|NCT01159171||
740295|NCT01159067||
740296|NCT01159054||
740297|NCT01159015||
740298|NCT01158976||
740299|NCT01158950||Subjects were screened for inclusion / exclusion criteria.
740300|NCT01158924||
740301|NCT01158885||
740302|NCT01158820|Patients were recruited from the practices of the pulmonologist sub investigators by the principal investigator|
740303|NCT01158716||
740304|NCT01158703||
740305|NCT01158651||
740306|NCT01158573|"OA Obese Asthma BMI >30
~NANO Non asthma non obese
~ANO Asthma non obese
~NAO Non asthma obese BMI >30
~Started July 2010 completed May 2013"|"Pre-assignment weight determined and pulmonary function testing prior to enrollment in observational study
~One time point study when mediators were mesaured."
740307|NCT01158534|Patients accrued from medical clinic from June 2006 through July 2009|
740308|NCT01158521||
740309|NCT01158404||Any participant who completed Cycle 1 or discontinued due to an adverse event (AE) in Part A is considered a completer. Any participant who completed cycle 1 or discontinued due to an AE or progressive disease in Part B was considered a completer.
740310|NCT01158378|The first subject was treated on September 3, 2010 and the last subject visit occurred on January 17, 2013.|Randomized study, no washout or run-in period.
740311|NCT01158261|The first subject was enrolled 04 June 2010 and the last subject was enrolled 15 April 2014. The last data point collected for the trial was 21 May 2014.|
740312|NCT01158222||5 additional patients were consented but not enrolled in the study. No information was collected on them and they are not included in the patient flow. Demographics information was not collected on these patients.
740313|NCT01158157||
740314|NCT01158118||
740315|NCT01157897|41 patients were enrolled (30 vaccination group, 6 infectivity control group and 5 alternates) and received treatment at the Clinical Trials Center (CTC) at Walter Reed Army Institute of Research (WRAIR)|
740316|NCT01157845||
740317|NCT01157676||
740318|NCT01157533|Recruitment Period: June 21, 2010 to January 4, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.|
740319|NCT01157429||A total of 63 youth were assessed. Only 47 meet all the inclusion and exclusion criteria and were offered treatment. Of those 47, only 24 were retained through session 5 of the treatment, which was the point of random allocation. Twenty-three subjects of the 47 subjects who were offered treatment dropped out prior to session 5.
740320|NCT01157416||
740321|NCT01157377||160 patients were enrolled, 3 patients did not receive treatment and 1 patient received an incorrect dose. 156 patients were included in the Safety Population.
740322|NCT01157364||
740323|NCT01157351||
740324|NCT01157234|"The trial was conducted at the University of Florida and Shands Renal Transplant Clinic.
~The first patient was randomized on July 8, 2010 and the follow up of the last patient ended on July 21, 2014."|32 participants were screened, 2 failed screening and 30 met the eligibility criteria and randomized to either the arm with nebivolol or the arm with metoprolol.
740325|NCT01157182||
740326|NCT01157169||
740327|NCT01157117|Recruitment took place at three university-based medical centers in the United States (Mount Sinai, Johns Hopkins University, Stanford University) beginning in October 2010. Accrual of randomized participants was completed in April 2012 and of untreated controls was completed in August 2012.|
740328|NCT01157078|This multicenter study was conducted in the United States and India between 22 June 2010 and 17 November 2011.|The study had an up to 21-day screening/washout period, and an 8-week prospective open-label antidepressant treatment (ADT) period to identify the target patient population of inadequate responders to ADT (<50% reduction in HAMD-17 total score during the prospective open-label ADT period, a HAMD-17 total score of ≥16 and a CGI-S score ≥4).
740329|NCT01157065|Subjects were recruited from 14 study centers in the US.|Of the 99 subjects enrolled, 48 were considered screen failures and were exited from the study prior to randomization. Of the 51 subjects randomized, 2 did not receive treatment. This reporting group includes all randomized subjects who received study medication.
740330|NCT01156987||31 were consented to enroll to start study with 23 breast cancer subjects and 8 healthy controls being able to complete the portion of the MRI study needed for analysis.
740331|NCT01156844||The study consisted of a 21 day screening period, a 14 day run-in period and a baseline assessment day prior to the 16 day treatment period. 1 participant randomized to 75 ug Indacaterol and 1 participant randomized to Placebo did not receive study drug and were not included in the Safety set milestone.
740332|NCT01156805|In 2006, the 16 schools in Granollers were randomly distributed to the intervention or control group stratified according to public or semi-private status, number of first-year's classrooms and socioeconomic status of the local neighborhood.|
740367|NCT01155180|Subjects who have successfully completed 1of the 4 hospital-based participating weight loss programs (Boston Medical Center, Tufts Medical Center, Massachusetts General Hospital, Beth Israel Deaconess Medical Center (BIDMC)-Joslin Center) & have achieved a >8% (average 10%, range 8-14%) weight loss will be invited to participate in the study.|
742700|NCT01025232||
740333|NCT01156792|A total of 341 participants (par.) were screened, and 162 participants were randomized. A protocol amendment necessitated withdrawal of all male participants and further enrollment of female participants only.|Par. meeting screening criteria, self-administered open-label fluticasone propionate 100 micrograms (µg) twice daily for 14-28 days. Eligible par. were assigned to 1 of 10 treatment sequences, receiving 4 of 5 double-blind treatments. Par. aged 12-14 years did not receive montelukast. Rescue medication (albuterol inhalation) was provided.
740334|NCT01156714||
740335|NCT01156701||
740336|NCT01156675||
740337|NCT01156597||
740338|NCT01156571|"Date first patient enrolled: 30 Sep 2010 Date last patient completed: 14 Nov 2012
~This trial enrolled the full spectrum of patients who required PCI (SA, NSTE-ACS, STEMI). Randomization occurred after confirmation of need for PCI (after diagnostic angiogram in all cases, except for STEMI patients). Patients were followed through 30-days."|Due to the nature of the disease, STEMI patients were permitted to be randomized upon ECG confirmation and prior to confirmation of need for PCI (prior to diagnostic angiography). Therefore in some cases, STEMI patients did not require PCI and therefore did not receive all study drug.
740339|NCT01156532||
740340|NCT01156480||
740341|NCT01156376||
740342|NCT01156363||Efficacy results are reported separately for each of the 3 centers involved in the study [China Medical University Hospital (CMUH); Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH); and Buddhist Tzu Chi General Hospital (BTCH)] as well as for overall treatment arm, unless otherwise specified.
740343|NCT01156311||
740344|NCT01156142||
740345|NCT01156116||
740346|NCT01156051|From 2010 to 2012, children were referred primarily from the outpatient practice affiliated with a community based hospital dedicated to the evaluation and management of children with special needs. Four patients were referred from community pediatricians who commonly refer to the practice.|Medications for ADHD, that would affect sleep/alertness, or that had psychoactive properties were discontinued prior to polysomnography. Of the 35 who entered screening, 29 were enrolled. Children were disquialified for not meeting diagnostic criteria or for having disqualifying conditions (e.g., depression, heart pathology).
740347|NCT01156012||Included patients= 404 patients but 2 patients without available data after Day 0. These 2 patients were excluded from the analyses sets.
740348|NCT01155999||
740349|NCT01155869|215 potential subjects were approached over a 16-month period of recruitment; only 15 agreed to be screen after hearing of study procedures.|5 were excluded (1 did not meet criteria for homelessness, 1 did not meet criteria for alcohol dependence, 1 had untreated delusional thinking, and 2 had opioid-requiring pain); 3 eligible participants did not appear for baseline interview and could not be found; only 7 were randomized.
740350|NCT01155830||
740351|NCT01155778||Study enrolled 12 participants and 4 participants were included in each of the 3 dose groups.
740352|NCT01155726|134 participants were recruited and enrolled at 1 study center located in Canada. A 24-hour washout period of no lens wear preceded the 30-day adaptation phase.|18 participants were enrolled but not dispensed--i.e., discontinued prior to the 30-day adaptation phase. 116 participants started the adaptation phase, and baseline characteristics are presented for this group. 2 discontinued during the adaptation phase and 15 discontinued between adaptation and Period 1 dispense. 99 were dispensed into Period 1.
740353|NCT01155661||There was a 54 week LY2216684 treatment Open-label Phase followed by 1 week Discontinuation Phase after abrupt discontinuation of treatment.
740354|NCT01155583||The 11 phase II participants were a separate population from phase I
740355|NCT01155570|Ninety-four participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.|Of the 752 participants registered, 4 participants did not have case report forms retrieved (2 whose registration was duplicated and 2 who did not receive Humira). Of the remaining 748 participants, 14 were excluded from analysis (7 changed hospital after registration, 7 didn't visit clinic after the first Humira administration).
740356|NCT01155531||
740357|NCT01155518||
740358|NCT01155479|Participants with a diagnosis of idiopathic PD for less than 5 years were selected to participate in this study.|In Part 1, participants were randomized to one of five treatment groups and treated for 26 weeks. In Part 2, which was conducted for an additional 26 weeks, participants continued taking the same study treatment from Part 1, except for placebo participants who were re-assigned to receive preladenant 5 mg twice daily.
740359|NCT01155466||A total 1076 participants were screened and 778 were randomized.
740360|NCT01155388||Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 (NCT01155375) and enrollment continued under Study AMAG-FER-CKD-251. Data is for the combined Study AMAG-FER-CKD-252 and Study AMAG-FER-CKD-251.The results for the combined studies are included in this record.
740361|NCT01155375||Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 (NCT01155388) was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The results for the combined studies are included in this record.
740362|NCT01155336||
740363|NCT01155323||
740364|NCT01155284|Four centers screened 79 participants were screened between August 2010 and May 2012. Participants aged 11-36 years, diagnosed with type 1 diabetes within the past 6 months were recruited. 9 participants were not randomized as 7 were deemed ineligible and 2 were lost to follow-up.|At a screening visit, participants underwent procedures to establish that all inclusion criteria were met and none of the exclusion criteria were met. All participants and if applicable, guardians provided written informed consent/assent at screening.
740365|NCT01155219||
740366|NCT01155193|Pre-term infants and children under 24 months with high-risk for respiratory syncytial virus (RSV) were enrolled between September 01 and June 30 during each RSV season from 2002 to 2016. The registry was conducted in Germany.|"Results were subdivided into four parts due to procedural changes including changes in the methods of study data reporting during the conduct of the study:
~Registry 02/03 - 06/07
~Registry 07/08
~Registry 08/09
~Registry 09/10 - 15/16"
740411|NCT01153581||
740412|NCT01153516||
740413|NCT01153503||
740368|NCT01155167|Eligible patients scheduled to undergo clinically indicated diagnostic or therapeutic cardiac catheterization via the transradial approach were invited to participate in the study|3 participants from the placebo group were excluded (2 secondary to insufficient or uninterpretable ultrasound data and 1 secondary to patient's access site change from transradial access (TRA) to femoral access).
740369|NCT01155154||
740370|NCT01155141||
740371|NCT01155063||
740372|NCT01155050|Subjects were recruited between January 1, 2010 and June 30, 2010. Recruitment was done at primary care clinics at three LSU Health Care Services Division locations in three Louisiana cities.|Potential subjects were screened for eligibility and then randomized within site to the four treatment arms.
740373|NCT01155024|Participants recruited between March 2011 and June 2011|10 participants recruited; 10 screened, 0 excluded
740374|NCT01155011||
740375|NCT01154985||
740376|NCT01154816||
740377|NCT01154751|This study planned to recruit up to 200 patients across 5-10 sites in the European Union. However, during the course of the study, intake was halted at 109 patients and the registry was terminated early because of slow enrollment, increased loss to follow-ups, and general lack of interest.|
740378|NCT01154699||"33 subjects were assessed for eligibility (20 asthma only, 13 asthma + OSA).
~12 were excluded, with 11 not meeting inclusion criteria, and 1 declining to participate."
740379|NCT01154673||
740380|NCT01154634|In total 25 participants were enrolled into the study at 2 medical centres (14 and 11 participants), 20 of them were randomised to treatment (10 at each medical centre) and all these 20 participants completed the study.|After enrolment, participant's eligibility for assignment to treatment was based on inclusion and exclusion criteria.
740381|NCT01154452||
740382|NCT01154335||
740383|NCT01154322||
740384|NCT01154296|Individuals seeking services at 9 sexually transmitted disease (STD) clinics across the U.S. were recruited, screened and randomized between April 2010 - December 2010.|Study personnel made 14,948 approaches to STD clinic patients; some were approached multiple times. Of the 6,239 consenting to be screened, 5028 were eligible (80.6%); 16 of these were not randomized due to: decision to decline (n=3), not returning (n=11), not testing with HIV/STD battery (n=1) and not completing baseline activities (n=1).
740385|NCT01154283||
740386|NCT01154231||
740387|NCT01154218||
740388|NCT01154192||
740389|NCT01154166|"A total of 347 participants were randomized; however, 2 participants were not dosed after randomization and were excluded from the Safety Population. An additional participant had no post-baseline assessment available and was thus excluded from the Intent-to-Treat Population. Thus, only 344 of the 347 randomized participants started the study."|After the 14-day Run-in Phase with placebo, eligible participants (par.) entered the 24-week Treatment Phase (TP) and were randomized 1:1 to ropinirole PR or placebo. After the TP, all par. were down-titrated for 7 days. Those who did not enter the extension study returned for a follow-up visit 4-14 days after the last dose of medication.
740390|NCT01154153|The study was performed in 8 study centers in the United States.|179 participants were screened in this study. 31 participants were screen failures and 8 participants did not continue to as the limit on the number of participants to be randomized had been reached. 140 participants were randomized.
740391|NCT01154140||Participants with histologically or cytologically proven diagnosis of locally advanced, recurrent, or metastatic non squamous non small cell lung cancer and tumors with measurable disease were enrolled. Participants were to be positive for translocation or inversion events involving the ALK gene locus as determined by an ALK break apart FISH test.
740392|NCT01154127||
740393|NCT01154101|A total of 40 participants with moderate to severe plaque-type psoriasis were enrolled. This study was conducted at eight centers in the United States: New York (2); Missouri (1); Oregon (1); Pennsylvania (1); Rhode Island (1); Texas (1); Washington (1), from 07 June 2010 to 09 November 2011.|Participants were asked to sign the informed consent form (ICF) at the Screening Visit, which was conducted within 21 days prior to administration of the first dose of study drug on Day 1.
740394|NCT01154088||
740395|NCT01154036||Participants in the Atorvastatin 20mg and Rosuvastatin 10mg arms who did not meet low density lipoprotein-cholesterol goals during Phase I were eligible for Phase II. Approximately 25% of participants in the ezetimibe 10mg+atorvastatin10mg arm continued to Phase II regardless of LDL-C control but were not included in any of the statistical analyses
740396|NCT01154010|Analysis in process as of December, 2016.|Analysis in process as of December, 2016.
740397|NCT01153984||Ninety participants were screened and 23 participants were enrolled.
740398|NCT01153971||
740399|NCT01153958||
740400|NCT01153893|The duration of the study depends on the group allocation. The duration of the study per subject can vary from 1 month (Synflorix/Infanrix primed Group) to 3 months (Synflorix/Infanrix unprimed Group).|Because of an issue with the informed consent of a child, the data of the child, who had a non-related to study medication serious adverse event, are not detailed in this analysis. Data were reanalyzed for the 104 subjects with data available.
740401|NCT01153841||300 subjects were enrolled in this study. 2 subjects among the 101 subjects in the Infanrix Hexa Group were not vaccinated due to consent withdrawal.
740402|NCT01153815||
740403|NCT01153763|Eligible participants received Dabrafenib (GSK2118436) 150 milligram (mg) twice daily and continued on treatment until disease progression, death, unacceptable adverse event (AE), or early termination of the study. The total duration of the study including a long-term follow-up phase was 5 years.|A total of 211 participants with histologically confirmed BRAF mutation positive metastatic melanoma (Stage IV) were screened for eligibility. 152 participants had a BRAF V600E or V600K mutation and 92 participants with positive mutation were included in the study.
740404|NCT01153724||
740405|NCT01153711||
740406|NCT01153698||There were 168 patients enrolled and treated. 161 of these patients received enoxaparin and switched to dabigatran etexilate (Pradaxa), 2 patients were only treated with dabigatran etexilate and 5 patients only received enoxaparin but did not switch to dabigatran etexilate.
740407|NCT01153685||
740408|NCT01153672||
740409|NCT01153633||
740410|NCT01153620|Location: Emergency roon in University Hospital|
740414|NCT01153425|Participants were recruited from the Philadelphia region via various modes of public advertisements (radio, newspapers, flyers).|To qualify for participation participants must have BMD T-scores of either the spine (L1-L4) or total hip of ≤ -2.5 or a history of osteoporotic fracture.
740415|NCT01153347|This multicenter study was conducted in the US and India between 15 June 2010 and 31 January 2012.|The study had an up to 21-day screening/washout period, and an 8-week prospective open-label antidepressant treatment (ADT) period to identify the target patient population of inadequate responders to ADT (<50% reduction in HAMD-17 total score during the prospective open-label ADT period, a HAMD-17 total score of ≥16 and a CGI-S score ≥4).
740416|NCT01153321|"This was a single centre study conducted at a medical research centre in Germany. The first patient was enrolled on 01 October 2010 and the last patient last visit was on 28 July 2011.
~A total of 71 subjects were enrolled to get 44 subjects that fulfilled the inclusion criterions."|
740417|NCT01153269||
740418|NCT01153009|Participants took part in the study at 58 investigative sites in the United States from 22 June 2010 to 20 March 2012.|Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, 15 mg vortioxetine, 20 mg vortioxetine, or 60 mg duloxetine.
740419|NCT01152996|Participants took part in the study at 143 investigative sites in the United States from 07 Sep 2010 to 31 May 2013.|Patients who completed Studies LuAA21004_315 (NCT01153009), LuAA21004_316 (NCT01163266), and LuAA21004_317 (NCT01179516) and were willing to continue, and judged by the investigator to benefit from a 52-week continuation treatment with Lu AA21004, were enrolled and received flexible doses of study drug, based on patient response and tolerability.
740420|NCT01152814|Overall, 64 participants ≥65 years of age were enrolled at 5 sites in Italy.|Blood samples for the determination of antibody titers were obtained prior to vaccination.
740421|NCT01152788||
740422|NCT01152697||
740423|NCT01152580|Recruitment started in September, 2008 and continued through February, 2010 using neighborhood and city newspapers, posting of flyers, on-campus advertising and news features in campus, local and city newspapers and the local news. Eligible subjects reported to the Center for Pharmacy Care at Duquesne University for screenings and assessments.|Eligible subjects were randomly assigned using a computer-generated randomization scheme to receive either placebo or melatonin at a 3:1 ratio (treatment:placebo). Participants and principle investigators were completely blinded to the group assignments throughout the entire study thus achieving allocation concealment.
740424|NCT01152554|This multicenter study was conducted in the US between 22 June 2010 and 07 February 2012.|The study had an up to 21-day screening/washout period, and an 6-week prospective open-label antidepressant treatment (ADT) period to identify the target patient population of inadequate responders to ADT (a HAMD-17 total score of ≥10 and a CGI-S score ≥3).
740425|NCT01152515||
740426|NCT01152450|A total of 94 patients entered the study and was treated whilst 89 patients completed the trial.|Randomised, double-blind, placebo controlled, cross-over design without washout phase between the three periods. Patients were randomized equally to one of the six sequences (ABC, ACB, BAC, BCA, CAB, CBA).
740427|NCT01152437||
740428|NCT01152385|Enrollment: 224 Study Start Date: May 2010 Study Completion Date: May 2011 Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)|Wash-out period for patients treated with anti-diabetes treatment at enrolment.
740429|NCT01152359||
740430|NCT01152307|Patients were recruited through online and newspaper ads by the Center for Survey Research in 17 cities: Atlanta, Baltimore, Boston, Chicago, Dallas-Ft. Worth, Denver, Detroit, Ft. Myers, Houston, Los Angeles, Minneapolis, New York, Phoenix, Portland, Raleigh-Durham, San Francisco, Washington, D.C. August 5, 2010-Jan 10, 2011.|Eligible patients received a mailed survey and were randomly selected to receive a DVD or no DVD and booklet about depression.
740431|NCT01152294|Participants were recruited through online and newspaper ads by the Center for Survey Research in 17 cities: Atlanta, Baltimore, Boston, Chicago, Dallas-Ft. Worth, Denver, Detroit, Ft. Myers, Houston, Los Angeles, Minneapolis, New York, Phoenix, Portland, Raleigh-Durham, San Francisco, Washington, D.C.|Participants were randomized to receive a DVD and booklet or no DVD and to participate by phone or IVR (automated telephone survey system).
740432|NCT01152190||
740433|NCT01152112||
740434|NCT01152021||
740435|NCT01151904|Due to lack of enrollment, this study was discontinued early.|
740436|NCT01151852|Between July 20, 2010, and Jan 17, 81 patients were enrolled in Asan Medical Center, Seoul, Korea.|Randomization was done in a double-blind manner and stratified by performance status (0-1 vs 2-3) and by the number of previous lines of tyrosine-kinase inhibitor therapy (2 or less vs more than 2).
740437|NCT01151813||
740438|NCT01151761|The location is the Stanford Cancer Center. The study was open to accrual 1/18/2011. The study closed on 9/28/2012.|
740439|NCT01151618|Participants were recruited and screened with spirometry and determination of expiratory flow limitation prior to being enrolled into the study.|"22 patient were recruited in June of 2010.
~13 patients studied
~(7 didn't tolerate balloon; 2 had an exacerbation )"
740440|NCT01151579|Recruitment began initially August 21, 2007 at the medical center ICU.|Patients were excluded if they had a known allergy or sensitivity to study medications or if baseline heart rate was greater than 110 bpm. Treating physicians detremined the need for and frequency of treatment with bronchodilator therapy. All other medications were allowed.
740441|NCT01151553||
740442|NCT01151540||Participants who successfully completed Study 304 were enrolled into this study.
740443|NCT01151449||
740444|NCT01151436||
740445|NCT01151423|Subjects with aTTP were recruited from 11 countries in Europe, Australia, Asia and United States (US). Only adults were recruited; no adolescent patients were enrolled, although the trial was open for adolescent patients. A total of 75 patients were included in the trial.|76 subjects were screened, 75 subjects were randomized (= Intent-to-treat [ITT] population): 36 in the ALX-0081 group, 39 in the placebo group.
740446|NCT01151410||
740447|NCT01151371||
740448|NCT01151345||
740449|NCT01151280|Patients who signed an informed consent form and met the inclusion/exclusion criteria for this study were enrolled. The first subject was enrolled for this study on October 06, 2009 and the last subject was enrolled on February 01, 2012.|
740450|NCT01151215||482 patients were enrolled into the study, of these, 123 patients failed screening and 359 patients were randomized, 120 to AZD8931 40mg(bd) plus anastrozole 1mg (od), 118 to AZD8931 20mg(bd) plus anastrozole 1mg (od) and 121 to placebo(bd) plus anastrozole 1mg(od)
740451|NCT01151189||
740452|NCT01151137|"Recruitment initiated in July 2010 was discontinued on July 6, 2011 upon recommendations of the Data Monitoring Committee due to an increased number of observed cardiovascular events in the Dronedarone group. The common study end date [CSED] was defined as July 15, 2011.
~At that time 494 sites in 37 countries had enrolled at least one patient."|"Assignment to groups was done centrally using an Interactive Voice Response System [IVRS] or an Interactive Web Response System [IWRS] in a 1:1 ratio.
~A total of 3236 participants were randomized at 489 sites (instead of 10800 as initially planned). The median duration of their participation in the study was 3.5 months."
740453|NCT01151098|16-Apr-2001 (first patient first visit) 27-Feb-2002 (last patient last visit). The extension phase of study was conducted at 20 sites in the US Baseline Period: and 18 sites in the UK.|Adult subjects aged ≥ 18 years, with chronic nonmalignant pain, controlled on oral opioid therapy. Subjects in the US who participated in the BUP3201 core study and met the criteria per Amendment 2, and subjects in the UK who participated in the BUP3201 core and met the inclusion/ exclusion criteria, were able to participate in the extension.
740454|NCT01151085||
740455|NCT01151046||
740456|NCT01151020||
740457|NCT01150981|dates of recruitment January 2007 to January 2010|
740458|NCT01150903||
740459|NCT01150760||
740460|NCT01150500|In this study the first patient was enrolled in June 2011 and the last patient was enrolled in January 2012 in eleven hospitals in Japan.|There was no significant episode for screening processes.
740461|NCT01150474|Subjects were recruited at the Mayo Clinic in Arizona, United States from January 2011 to April 2013.|
740462|NCT01150461|Dates of recruitment 4-07 through 3-10.|
740463|NCT01150409||
740464|NCT01150357|The study was conducted at 51 centers in 8 countries.|A total of 334 participants were screened and placed in screening phase of single blind placebo washout period for up to a maximum of three weeks. Out of 334, 268 participants were randomized in Phase 1 including 1 mis-randomized participants who did not receive any medication. Therefore total of 267 was enrolled in this study
740465|NCT01150123|Subjects were enrolled at one center in Belgium|"Group1: 5 µg-1Inj-No Adj, 5 µg-2Inj-No Adj, 20 µg-1Inj-No Adj, 20 µg-2Inj-No Adj (Cohort 1), 5 µg-1Inj-Alum, 5 µg-2Inj-Alum, 20 µg-1Inj-Alum, 20 µg-2Inj-Alum (Cohort 2).
~Group 2: 5 µg-1Inj-MF59_F, 5 µg-2Inj-MF59_F, 20 µg-1Inj-MF59_F, 20 µg-2Inj-MF59_F (Cohort 3), 5 µg-1Inj-MF59_H, 5 µg-2Inj-MF59_H, 20 µg-1Inj-MF59_H, 20 µg-2Inj-MF59_H (Cohort 4)"
740466|NCT01150097|Two hundred eight four participants were eligible and enrolled into the extension. However, 2 participants withdrew from the extension prior to receiving treatment. Therefore, a total of 282 participants were accounted for in the extension.|Participants in the tacrolimus control group were studied for 12 months (from months 24 to 36 post transplant). Participants in the tacrolimus elimination and everolimus + reduced tacrolimus groups were studied for a minimum of 12 months up to 24 months (from months 24 to 48 months post transplant) depending on the participant's study start.
740467|NCT01149876|Recruitment period 2010-2011.|Wash out period to allow subjects to d/c any topicals that would interfere with study or met exclusion criteria.
740468|NCT01149863||
740469|NCT01149785||
740470|NCT01149772||
740471|NCT01149759||
740472|NCT01149733||
740473|NCT01149681||
740474|NCT01149655|A Phase 3 randomized, double-blind, placebo-controlled study consisted of screening period, conversion (Period 1), stabilization (Period 2), double-blind maintenance treatment (Period 3) and a follow-up period to evaluate efficacy and safety of aripiprazole (10-30 mg/day) compared to placebo in adolescent participants with schizophrenia.|Participants were titrated to oral aripiprazole in Period 1. Participants who converted to aripiprazole and who already received aripiprazole were in Period 2. Participants met stability criteria were randomized in 2:1 ratio (aripiprazole: placebo) in Period 3. 244 participants were screened of which 201 entered the trial and 146 were randomized.
740475|NCT01149616|2010|
740476|NCT01149538||
740477|NCT01149512||
740478|NCT01149486||
740479|NCT01149473||
740480|NCT01149460||
740481|NCT01149434||
740482|NCT01149421||
740483|NCT01149369|Between April 2013 and July 2015, 126 patients were enrolled at eight participating medical centers, of whom 63 were randomized to aprepitant and 63 to placebo|Adults, 18 years or older, with symptoms compatible with gastroparesis for 6 months, who had a 4-hour gastric emptying scintigraphy test and a total score >21 on the Gastroparesis Cardinal Symptom Index (GCSI) and a visual analog scale (VAS) mean score of nausea after 7 days of >25 mm on a 0 to 100 mm scale were considered for enrollment.
740484|NCT01149343||
740485|NCT01149148|Recruitment period: 11-2009 to 9-2011|
740486|NCT01149096||
740487|NCT01149057||
740488|NCT01148979|35 potential subjects were screened for eligibility between September 2010 and April 2014 at McLean Hospital in Belmont, MA.|Of the 35 subjects screened, 29 were randomized. Of the 6 not randomized, 3 did not meet inclusion criteria, 1 withdrew consent, and 2 were lost to follow post screening. Of the 29 randomized, 28 completed both parts of the study. One subject was lost to follow after 3 weeks in the first half. Data were analyzed for the 28 completers only.
740489|NCT01148940||
740490|NCT01148862||
740491|NCT01148836||
740492|NCT01148810|The study was terminated after 18 patients had been enrolled, of which 14 were eligible for the primary efficacy analysis.|
740493|NCT01148771|Healthy adult volunteers were recruited in August/September 2010.|The target enrollment of 12 volunteers was met. All 12 participants completed at least one phase of the study, while 11 completed the entire study.
740494|NCT01148745||
740610|NCT01143051|Participants were recruited from a specialty clinic in Cypress, CA between 04/29/2010 and 05/27/2010|A total of 38 subjects were screened, 24 subjects passed screening, consented and were randomized for participation in the study. The IRB approval date was 04/29/2010, the last subject was screened on 05/27/2010.
740495|NCT01148693|Between December 2009 and October 2010 all patients with non-calculus biliary obstructions including cholangiocarcinoma, pancreatic cancer, sclerosing cholangitis, postsurgical benign biliary strictures and biliary stenosis due to metastatic cancers to biliary tree who were candidate for palliative stenting, were included in this study.|Exclusion criteria were patients with biliary stones, patients who were candidate for surgical cure, and patients who were already febrile.
740496|NCT01148563|"Subjects were nested within LSU HCSD clinics. Potential subjects were approved by their physicians for inclusion in addition to meeting the stated inclusion criteria.
~Study recruiters contacted the potentially-eligible subjects at the times of their next scheduled clinic visits. Recruitment Period: 3/9/09-8/31/10."|Of the original 137 subjects recruited, one subject in the treatment group withdrew from the study prior to having home monitoring equipment installed, leaving a total of 136 subjects.
740497|NCT01148537|02-Jul-2004 (first patient first visit) to 16-Dec-2004 (last patient last visit) at 1 site in the US (Austin, TX.)|During the initial screening visit, subjects were assessed for study eligibility through medical history, physical examination, vital signs, oxygen saturation, conventional 12-lead ECG, and laboratory tests. The investigator at the site examined the ECG telemetry to determine the subjects' eligibility.
740498|NCT01148524|Subjects were enrolled at six study sites in Chile.|All enrolled subjects were included in the trial.
740499|NCT01148511||
740500|NCT01148459||
740501|NCT01148420|Participants were recruited from the GYN clinic at the Harbor-UCLA Medical Center.|Women were excluded if they were pregnant, hemodynamically unstable, had a known endometrial or cervical carcinoma, required immediate surgery, had hemoglobin less than 8, or had failed an earlier hormonal treatment for the current episode of bleeding.
740502|NCT01148225||A total of 424 participants were enrolled and received ≥1 dose of study drug (Safety population); 364 participants were included in the intent-to-treat (ITT) population (reasons for exclusion: incomplete efficacy data or GCP compliance issues at 2 sites (n=7); diabetic retinopathy [n=1]; cataract surgery [n=26]; and previous vitrectomy [n=26]).
740503|NCT01148056||
740504|NCT01148017||
740505|NCT01147926||
740506|NCT01147900|Subjects consisted of those previously vaccinated & boosted in GSK263855/029 study and contacted for participation in this booster (BST) study. Duration of this study was about 19 months, from Year 8.5 (8.5 years post BST in GSK263855/029 study) to one month post BST in this study (Year 10 [10 years post BST in GSK263855/029 study] + one month).|At Year 8.5, a total of 180 subjects (out of the 478 planned) were enrolled: 54, 60 and 66 subjects in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively. At Year 10, a total of 177 subjects (out of the 180 planned) were enrolled: 55, 60 and 62 in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively.
740507|NCT01147874||
740508|NCT01147848||
740509|NCT01147822|Study VEG113078 is a substudy of Study VEG108844 (NCT00720941). Due to the projected limited enrollment of Asian participants into Study VEG108844, Study VEG113078 was designed to evaluate the efficacy and safety of pazopanib versus sunitinib for the treatment of Asian participants (par.) enrolled from selected Far-East Asian countries.|Par. from China, Korea, and Taiwan who enrolled in either Study VEG108844 or VEG113078 and par. from Japan who enrolled in Study VEG108844 were pooled for analysis of the Asian population, presented in this report. Only 183 participants were enrolled in Study VEG113078 (as reflected in the Enrollment field in the Protocol record).
740510|NCT01147809|Participants (par.) with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin were eligible for enrollment into the study. The study comprised of 2 phases (I & II), with eligible par. being randomized to receive placebo or eltrombopag in each phase.|A total of 108 par. were randomized, of which 101 par. received at least 1 dose of study drug. A maximum of 6 cycles (with some exceptions) of chemotherapy with eltrombopag/placebo were allowed in each phase (either 21-day or 28-day cycle) followed by the 30 day Follow-up visit.
740511|NCT01147744|A total of 1245 participants were screened, of these, 363 participants failed screening, 882 entered the run-in phase and a total of 700 participants were randomized and included in Intent to Treat (ITT) Population . The study was conducted from 28 Jun 2010 to 06 October 2011, in the Ukraine, United States, Bulgaria, Poland, Japan, Romania.|Participants were screened (Visit 1) for eligibility, which included reversibility testing. Following screening and a 14-days Run-in Period, participants who met the eligibility criteria for randomization to study treatment at Visit 3 were randomly assigned to receive one of seven double-blind treatments for 8 weeks.
740512|NCT01147653||Participants were enrolled and randomized on the same day.
740513|NCT01147640||
740514|NCT01147627||
740515|NCT01147601||
740516|NCT01147497|Enrollment occurred at a faculty practice clinic affiliated with Emory University.|Seventy-eight nulliparous women were enrolled, and 71 completed the study. Five dropped out prior to randomization and method insertion choosing other birth control options.
740517|NCT01147471|Adult patients, 21 to 75 years old, admitted to the trauma unit with injuries that include either stove in chest (contiguous rib fractures with at least 2 ribs pushed in a distance greater than the rib diameter of the pushed in rib) or a unilateral flail chest (3 or more ribs fractures at two places). Patients must be on a ventilator.|
740518|NCT01147458||
740519|NCT01147406||
740520|NCT01147393||
740521|NCT01147380||
740522|NCT01147341|all patients recruited from US medical/Rheumatology clinics|patients excluded from protocol if they did not meet entry criteria for active Rheumatoid arthritis
740523|NCT01147302||
740524|NCT01147250|The study was conducted at 829 centers in 49 countries. A total of 7719 participants were screened between June 24, 2010 and July 24, 2013. 1651 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.|7627 participants underwent 1 week placebo run-in period. 1559 were run-in failures due to exclusion criteria met. 6068 participants were randomized 1:1 to lixisenatide and placebo arms in double-blind treatment period. Duration of study was event driven until approximately 844 positively adjudicated primary cardiovascular (CV) outcome events.
740646|NCT01140815|Patients were recruited preoperatively in a clinical setting between 2007-2010.|Patients with only unicondylar arthritis were excluded and underwent unicondylar arthroplasty. Patients with arthritis in the lateral compartment were excluded and underwent total knee arthroplasty.
740525|NCT01147172|A total of 122 subjects were screened for the study at 9 centers. Twenty-two screen failed and 100 were were enrolled in this study. No subject who failed screening was treated during the CTA-0701 study. Of the treated subjects 96% completed the follow-up visit 24 weeks after Treatment.|Elevess was injected into the mid to deep dermis of each nasolabial fold. Subjects were telephoned at 72 (±24) hours to assess the subjects for possible AEs and injection site reactions. All subjects returned 14 ± 3 days after initial treatment for evaluation of AEs and to assess whether a Touch-up was needed.
740526|NCT01147068|Healthy adults 18-49 years of age were screened in participating outpatient clinics for eligibility within 30 days of randomization during the 2010 influenza season.|Subjects whose laboratory values were exclusionary were not randomized. Women of child-bearing potential were required to have a negative pregnancy test.
740527|NCT01147055||
740528|NCT01147042||
740529|NCT01146951||Of n= 66 who started Observation Period, 7 discontinued from study. Primary reasons were deviation of the inclusion/ exclusion criteria (n=5), untoward event before study treatment (n=1) & other (n=1). Of 59 participants, 58 were included in full analysis set (FAS). 1 participant (E2080 group) was excluded due to inappropriate diagnosis of disease.
740530|NCT01146912|Children and pregnant women receiving care at 4 community-based clinics in the United States during the 2010-2011, 2011-2012 influenza season|Children previously vaccinated for influenza before the season of interest were excluded from primary analysis
740531|NCT01146873|A total of 300 study participants were recruited between June 2010 and October 2012.|Two children discontinued the study prior to randomization.
740532|NCT01146860|January 2010 to April 2010 37 centres (16 ENT and 21 specialists in internal medicine and general practitioners|
740533|NCT01146834||
740534|NCT01146808||
740535|NCT01146782|Subjects for the study were recruited from the Investigator's sleep clinic or through advertising. Advertisements were approved by the applicable Institutional Review Board (IRB) prior to use.|Initial screening phase consisted of initial medical/dental and eligibility screening. Subjects then underwent an Oxygen Desaturation Index (ODI) screening (confirming ODI of 10-60) and one night of home use with the study device to screen for proper fit.
740536|NCT01146704||
740537|NCT01146665||
740538|NCT01146613||
740539|NCT01146600|Most subjects were recruited from the patient population of a single Sleep Center affiliated with Emory University School of Medicine. One subject contacted investigators for participation after reading of the study on clinicaltrials.gov. The first patient was recruited 3/5/11 and the final patient completed the study on 9/28/12.|All subjects underwent screening laboratories after enrollment but before beginning medication. In the case of abnormal laboratory results (n = 2), subjects did not begin treatment with either study drug (clarithromycin or placebo). One patient dropped out after consent but before randomization (because of scheduling conflict).
740540|NCT01146496||
740541|NCT01146457||
740542|NCT01146418||Period 1 consists of participants from Base Study P06029 (NCT01144416) randomized to treatment groups corifollitropin alfa or recombinant follicle stimulating hormone (recFSH). Period 2 consists of participants from base study enrolled in Follow-Up Study P06031. Period 3 consists of infants born to expectant mothers in Follow-Up Study P06031.
740543|NCT01146379||
740544|NCT01146288|Participants recruited between July 2010 and October 2012.|19 screened, 6 excluded (2 did not meet inclusion criteria, 2 refused participation, 2 unable to adequately collect urine).
740545|NCT01146275||
740546|NCT01146054|Patients were recruited during new patient clinical visits between 10/22/2009 - 08/14/2013 at Stanford University, Johns Hopkins University and Memorial Sloan-Kettering Cancer Center. Study details were explained by the physician and consent was obtained by the physician or study coordinator according to good clinical practices.|
740547|NCT01145898|recruitment over 6 months. Hospital and area eye clinics|observational study, patients were treated by their physician not by study personel, treatments/interventions were self-reported by the patients, treatment was not necessarily started at glaucoma diagnosis
740548|NCT01145885||All participants entered the first treatment cycle, if they experienced clinical benefit from the first treatment course they could continue into further treatment courses.
740549|NCT01145833||
740550|NCT01145755|This study was conducted only in the United States (US). A total of 13 study centers enrolled 249 patients. First subject enrolled: 27 May 2010 Last subject last visit: 10 November 2010|Patients with major depressive disorder were included.
740551|NCT01145638||
740552|NCT01145625||
740553|NCT01145560|Subjects were screened and enrolled from approximately 100 centres worldwide.|
740554|NCT01145547|Seven subjects with Type 1 diabetes mellitus on subcutaneous insulin pump therapy were recruited from clinics in Portland, Oregon, USA.|
740555|NCT01145508|Participants were recruited from Eastern Cooperative Oncology Group (ECOG) member institutions between December 29, 2010 and March 26, 2012.|
740556|NCT01145495|Between June 2010 and November 2011, 66 participants were recruited.|Three participants did not receive protocol treatment and were dropped from all analyses.
740557|NCT01145482||
740558|NCT01145417|Following completion of Visit 9 (Day 57) of double-blind trial A0081244 (NCT01049217), participants who met eligibility criteria initiated open-label treatment in the current trial A0081251 (NCT01145417).|
740559|NCT01145391|Dates of the recruitment period: September 2009 - January 2010. Types of locations: University of Colorado Hospital primary care clinics|Patients were excluded if they had serious comorbidities (e.g. active cancer diagnosis, hospice care, end-stage renal disease), diabetes mellitus, BP management by a nephrologist or other sub-specialist, a notation of white coat hypertension, or a notation that patient should monitor BP at home.
740560|NCT01145352||
740561|NCT01145222||
740562|NCT01145209||
740647|NCT01140646|Forty-five (45) subjects were recruited between October 2010 and January 2012 at Mayo Clinic.|Two subjects were ineligible and excluded from all analyses except adverse events summary.
740648|NCT01140568||38 people were enrolled in the study and 34 were treated with study drug. When patients came off treatment they moved into survival follow up.
747565|NCT00775593|Between April 2009 and June 2010, 60 patients were enrolled in the study at 14 different Italian institutions.|
740563|NCT01145183|A total of 201 individuals seeking treatment for cocaine dependence were screened between October 2009 and September 2013 at the Outpatient Clinical Trials Research Clinic at MEDVAMC. 16 participants were excluded because they did not meet the inclusion criteria, and 89 participants were lost to follow up before randomization into this study.|Thus, 96 individuals entered into the study and were randomly assigned into the doxazosin or the placebo groups. Following randomization, 7 participants were lost to follow up and 13 opted out of the pharmacogenetic testing. In total, 76 CUD patients participated in this trial.
740564|NCT01145066||80 participants signed consent, only 71 were randomized to an arm/group
740565|NCT01145053|A total of 361 patients were enrolled. Of these patients, the CRF of 4 patients were uncollected by reason of institution, and the 16 patients who did not visit after enrollment. Then, total 341 patients were observed in the survey.|
740566|NCT01145001||
740567|NCT01144949||
740568|NCT01144715||
740569|NCT01144663||
740570|NCT01144637||
740571|NCT01144624|Subjects were screened and enrolled at six centres in Japan.|
740572|NCT01144598||
740573|NCT01144494||2 subjects consented and then dropped out prior to assignment.
740574|NCT01144455||
740575|NCT01144442|Women were recruited from the Women's Health Clinic at the University of Minnesota. Recruitment occurred from September 2010 to April 2012.|Once subjects signed consent, they underwent cytoreductive surgery by a gynecologic oncologist with intent to resect all visible cancer. If subjects did not achieve optimal cytoreduction, they were ineligible.
740576|NCT01144416|Women, aged between 35 and 42 years, with an indication for controlled ovarian stimulation and in vitro fertilization/intracytoplasmic sperm injection without a history of previous hyper or low ovarian response to follicle-stimulating hormone/human menopausal gonadotropins, ovarian hyperstimulation syndrome (OHSS), or polycystic ovary syndrome.|1424 participants were originally enrolled in the study. All data for 1 participant, who was incorrectly randomized and did not receive study medication and for all 33 participants at 1 clinical site were excluded from all analyses, including disposition, prior to unblinding. Only women who became pregnant continued into Pregnancy Follow-up period.
740577|NCT01144403||A total 8 participants were enrolled from Romania.
740578|NCT01144377||After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
740579|NCT01144364||
740580|NCT01144338||
740581|NCT01144299||
740582|NCT01144286|The subjects were randomized to a treatment arm using an interactive web response system (IWRS). Placebo and study drug pessaries were dispensed as a kit, and all subjects were instructed in proper self-administration of the pessaries (at bedtime while lying down). Study initiation date was 15June2010 and completed on 15 Nov 2010.|After signed informed consent, VVC clinical signs and symptoms were assessed,(KOH) wet mounts and samples for mycological culture obtained.Baseline safety assessments, including pregnancy were performed. If all inclusion criteria and none of the exclusion criteria were met, the subject was randomized in the same day to one of the treatment groups.
740583|NCT01144182||
740584|NCT01144143||
740585|NCT01144052|Recruitment period: 2010 to 2011 Out-patients of Neurology ambulatory|
740586|NCT01144026||
740587|NCT01143896|We recruited a total of 309 patients from CHC clinics at 4 VAs (Houston, St Louis, Little Rock, and Los Angeles) between April 2012 and September 2013. Of these, 292 patients completed baseline interviews. Follow-up data-collection interviews were completed for 263 (90.1%) participants at 6-months and 242 (78.3%) participants at 12-months.|
740588|NCT01143883|All 110 patients were consented for this study during their pre-operative visit.|
740589|NCT01143870||
740590|NCT01143818|Participants enrolled in this study were newly-diagnosed for hypogonadism and treatment naive to testosterone preparations. A total of 1053 participants were enrolled but only 1049 were treated with AndroGel.|AndroGel (testosterone gel) 1% was prescribed according to the regional Summary of Product Characteristics with a starting dose of 50 mg testosterone/day (packaged as 1 sachet of 50 mg). Testosterone was applied once daily.
740591|NCT01143792|recruitment ended on time, recruitment completed as proposed.|intent to treat design used.
740592|NCT01143766||
740593|NCT01143727|Adults aged 18 years and older, with Type I or II diabetes mellitus and at least one inflamed diabetic foot ulcer|
740594|NCT01143714|Adults aged 18 years and older, with a diabetic foot ulcer that has not responded to treatment|
740595|NCT01143701||
740596|NCT01143688||79 patients completed questionnaires, 46 patients had reversibility and were randomized, and 39 completed the whole trial. The data was solely based on the 39 subjects who completed the entire trial.
740597|NCT01143649||
740598|NCT01143636||
740599|NCT01143610|Patients both genders, 18-45 years, showing at least one site with gingival recession should attend the Graduation Clinics of Periodontics, School of Dentistry at Bauru-USP, from October to December 2007 for enrollment in a new treatment protocol.|Participants were excluded from the study prior to group assignement in cases of pregnancy, diagnosis of systemic disease or if the patient quit participating.
740600|NCT01143402||
740601|NCT01143389||
740602|NCT01143337||
740603|NCT01143324||In total 255 patients were enrolled. Three patients were not submitted to a minimally invasive MAST fusion procedure and therefore excluded from further analysis. Number of participants started in the participant flow is 252.
740604|NCT01143272||
740605|NCT01143259|Date of first enrollment5-24-2010 Date of last enrollment 6-13-2012 Patients were identified in surgeons office and then screen by study coordinators for eligibility.|Most common exclusion were patients with history of opioid us > 3 doses in 7 days prior to surgery.
740606|NCT01143207||
740607|NCT01143142||
740608|NCT01143090|FPI August 10, 2010-LPV November 28, 2011, locations were private health clinics, university hospitals, private research facilities.|
740609|NCT01143077|FPI June 24, 2010-LPV May 19, 2011, locations were private health clinics, university hospitals, private research facilities.|
740611|NCT01143038|Ninety-eight adults with immune thrombocytopenia purpura (ITP) were screened for the study; 23 were considered screen failures. Seventy-five participants were enrolled at 32 study centers in Australia, the European Union, and North America from 30 November 2010 to 21 September 2012.|The study included a 12-month romiplostim treatment period, and a romiplostim dose-tapering period. Participants who maintained a platelet count of ≥ 50 x 10^9/L in the absence of romiplostim and all medications for ITP (concomitant or rescue) were followed for at least 6 months to confirm the incidence of ITP remission.
740612|NCT01142947|362 self-reported African American enrolled in 6-week treatment with inhaled beclomethasone dipropionate; 291 returned at the end of treatment; 262 with measurable medication adherence; 244 with genome-wide genotype data.|
740613|NCT01142908||
740614|NCT01142791||The protocol defined the primary analysis to include participants receiving more than 1 sonication, i.e., 115 in this case. The safety population was defined in the protocol as participants receiving any sonications which is 121. 6 subjects receiving only 1 sonication were in the safety population but not in the baseline or primary analysis.
740615|NCT01142726||A total of 511 patients were enrolled in the study, and 351 were randomized. The primary reasons that 160 enrolled patients were not randomized were failure to meet study criteria (130/160) and withdrawal of consent (20/160).
740616|NCT01142661|This study was recruited at 5 centers in the US during the period of Aug 2010 to Aug 2011.|
740617|NCT01142596||
740618|NCT01142466|Participants were enrolled at multiple centres in Germany.|A total of 36 participants were screened and 30 were randomized to the study treatment. 6 participants were not treated (4 participants were screening failures and 2 participants did not meet the inclusion and exclusion criteria).
740619|NCT01142388|This study was activated on September 21, 2010 and closed to accrual on October 15, 2012 with total accrual of 94 patients from 27 ECOG-ACRIN affiliated institutions.|
740620|NCT01142336|Statin-naïve middle-aged adults were recruited for this single-site trial (Seattle, WA) from the University of Washington Alzheimer's Disease Research Center Registry or the community through newsletters, websites, educational talks, health fairs, local clinics, and newspaper and magazine advertisements.|"917 people were pre-screened by phone for eligibility, 400 did not respond or declined, 457 did not meet inclusion/exclusion criteria.
~60 completed a full screen visit. Of these 60 potential participants, 2 were lost to follow-up after screen, 2 withdrew, 7 screen failed and 49 were enrolled and randomized."
740621|NCT01142323||
740622|NCT01142310||
740623|NCT01142297||
740624|NCT01142232|This protocol was based on enrolling up to 16 patients phase I and up to 46 patients in phase II. The study enrolled 60 patients with 16 in phase I and 44 in phase II.|
740625|NCT01142193|This study was conducted in 16 countries (Argentina, Australia, Belgium, Canada, Chile, Germany, Greece, Hungary, India, Israel, New Zealand, Poland, Russia, South Africa, Spain, and United States). At least 1 subject was enrolled at 66 study centers, of which 60 study centers randomly assigned at least 1 subject to study drug.|Subject had to have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days during the 8-week baseline to be randomized into the trial.
740626|NCT01142128|The dates of the recruitment period were February 2009 through January 2010. Subjects recruited at the University of Florida and the Shands Hospital. Recruited a total of 12 subjects. Enrollment was slow due to subjects not wanting to come off their medications, this was unanticipated.|A total of 12 participants were consented to the study, however, 4 participants were never randomized to the study. Prior to randomization, subjects were off all enzymes and proton pump inhibitor's (PPI's) for 14 days.
740627|NCT01142115|January-May, 2010, Department of Urology, Rigshospitalet, Denmark|
740628|NCT01142089||
740629|NCT01141907||
740630|NCT01141725||
740631|NCT01141712|Participants were enrolled between April 2010 and March 2013 from 16 different transplant centers.|Three patients did not undergo transplantation due to disease progression prior to conditioning.
740632|NCT01141660||
740633|NCT01141647||1047 subjects were enrolled; 450 were ineligible for supported employment (SE) services and 318 were out of the SE recruitment window. 279 SE participants remained, and 66 were analyzed separately because of their previous participation in SE. For the purposes of reporting 213 subjects were included
740634|NCT01141608||
740635|NCT01141595|All patients were recruited from a medical clinic specalizing in neurodevelopmental disorders|No significant events
740636|NCT01141569||
740637|NCT01141491||
740638|NCT01141374|Recruitment was conducted between January and July 2010 at University Hospital. Study participants were professionals from different sectors of the hospital after the invitation and 109 people answered the first questionnaire of stress (LSS). Obeying the exclusion criteria, 75 subjects were enrolled and randomized into three groups.|Withdrawal:employees went on vacation(7),sick leave(2), lost treatment for loss of time, forgetfulness,difficulty of rescheduling (12), withdrawal due to side effects, in this case, nightmares (1); low score (1), not belonging to the nursing staff (3), failure to attend the first session (7) not having completed the questionnaires (1)
740639|NCT01141283|28-May-2003 (first patient first visit) to 02-Jul-2004 (last patient last visit of extension phase). This study was conducted at 11 medical/research sites in the U.S.|"All subjects meeting the protocol-specified definition of double blind phase completer were eligible to participate in the extension phase within 3 days. Completers were defined as those who either developed inadequate analgesia in the double-blind phase or completed all 28 days of the double-blind phase on study drug with adequate analgesia."
740640|NCT01141205|medical clinic|
740641|NCT01141075||
740642|NCT01141049||
740643|NCT01140906|Patients were selected from psychiatric settings (private practices), outpatient clinics, and inpatient hospitals.|At the Baseline Visit, patients who fulfilled the selection criteria were assigned to treatment with either placebo, vortioxetine 15 or 20 mg/day, or duloxetine 60 mg/day in a 1:1:1:1 ratio.
740644|NCT01140880||
740645|NCT01140867|This study was recruited at 10 centers in Korea during the period of February 2008 to August 2010.|
740687|NCT01138111|A total of 71 patients were screened at one study center in Australia. The first subject's consent was obtained on 02 JUN 2008.|26 subjects were screen failures and did not have study drug administered.
740688|NCT01138098||
740649|NCT01140503|This is a single center study in which patients were recruited from a clinical practice. Participant recruitment lasted from December, 2009 until August, 2011. The first patient was screened in February, 2010 and the last patient visit was in July, 2011.|
740650|NCT01140477||
740651|NCT01140451|This was a multicenter, open-label extension study of the safety and efficacy of ataluren in male and female participants with nonsense mutation cystic fibrosis (nmCF) aged ≥6 years who successfully completed Study PTC124-GD-009-CF (NCT00803205 [Study 009]).|Participants began the open-label extension study immediately after completing end-of-study visit (Week 48) in Study 009 to avoid interruption in treatment. Most assessments performed at Study 009's final visit were used as Baseline assessments in Study PTC124-GD-009e-CF (009e). Investigators and participants remained blinded to Study 009 dosing.
740652|NCT01140360||
740653|NCT01140347||Participants who died due to any cause or were alive and on study at conclusion but off treatment were considered to have completed the study.
740654|NCT01140295|Patients were recruited at The Children's Hospital of Philadelphia Main site Endoscopy suite from September 2010 to April 2011.|365 patients were screened. 98 were eligible according to inclusion/exclusion criteria. 41 declined participation. criteria. Of the 57 eligible patients 33 were enrolled when the study was prematurely terminated.
740655|NCT01140191|Recruitment was held 06Sep13 thru 17Dec2013 at study center WRNMMC at Bethesda 8901 Wisconsin Ave., Building 7, 1st Floor Bethesda, MD 20889|Statistical analysis was not performed as only a single subject was enrolled. No PK analysis was performed as this subject elected not to participate in the PK part of the study.
740656|NCT01140061||
740657|NCT01140048||
740658|NCT01139996||
740659|NCT01139879||
740660|NCT01139814||
740661|NCT01139801||
740662|NCT01139775||
740663|NCT01139762||The study consisted of 3 periods: a 4-week washout period, a 4-week, single-blind, placebo lead-in period, and a 26-week double-blind randomized active treatment period. Participants who did not complete the washout and placebo lead-in period were considered screen failures.
740664|NCT01139658||
740665|NCT01139580||
740666|NCT01139515||
740667|NCT01139450||
740668|NCT01139411||
740669|NCT01139294||17 participants were enrolled into the study per the final report to the Institutional Review Board. Actual study data was lost, so arm assignments are unknown.
740670|NCT01139190|Recruitment initiated: 01 July 2010, Multicenter trial: Private practice setting and Veterans Administration gastroenterology clinic.|No run-in period; subjects screened and enrolled based on review and confirmation of eligibility per inclusion/exclusion criteria. Wash-out period for NSAIDs and gastroprotective agents.
740671|NCT01139164||
740672|NCT01139125||
740673|NCT01139047|Dates of recruitment period: First subject was enrolled on June 7, 2010 and the last subject was enrolled on June 7, 2010.|Wash-out period up to baseline for topical treatment on the treated area was less than 1 week for corticosteroids and/or 4 weeks for retinoids; for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
740674|NCT01139021|Participants were enrolled from Finland and Czech Republic study center.|The eligible subjects from V72P13E1 (NCT00847145) who originally participated in the open-label, immunogenicity subset of parent study V72P13 (NCT00657709) and a naïve group, at 24 months of age, who did not previously participate in V72P13 (or V72P13E1) were enrolled in this study.
740675|NCT01139008|"Dates of recruitment period: First subject was enrolled on June 7, 2010 and the last subject was enrolled on June 7, 2010.
~Types of location: Investigative site was located at a research center."|Wash-out period up to baseline for topical treatment on the treated area was less than 1 week for corticosteroids and/or 4 weeks for retinoids; for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
740676|NCT01138995||
740677|NCT01138969|"Dates of the recruitment period: From August 2008 to August 2012
~Type of location: Kaohsiung Veterans General Hospital"|None were excluded following participant enrollment.
740678|NCT01138917||
740679|NCT01138826||
740680|NCT01138735||
740681|NCT01138657|This study includes a Japan sub-study. 239 participants with active non-infectious intermediate uveitis, posterior uveitis, or panuveitis were randomized worldwide, including 223 participants at 67 sites in Australia, Europe, Israel, Latin America, and North America (Main Study), and 16 participants randomized at 7 sites in Japan (Japan sub-study).|"Participants were randomized in a 1:1 ratio double-masked fashion stratified by baseline immunosuppressant usage. Participants recruited in the Japan sub-study were randomized in a separate stratum with no stratification by baseline immunosuppressant usage.
~Study completion was defined as meeting treatment failure or reaching study Week 80."
740682|NCT01138514||
740683|NCT01138501|Of a total of 39 initiated trial sites, 26 sites enrolled and dosed at least one patient. The country distribution was as follows: Brazil (3), Italy (1), Lithuania (1), Macedonia (1), Malaysia (1), Poland (2), Russia (2), Serbia (1), Taiwan (1), Turkey (3) and the United States of America (10).|
740684|NCT01138475|Subjects have been recruited from our patients who underwent gastric bypass surgery. They needed to be able to give informed consent, age > 18 years, within 12 months of RYGB being performed, post-operative iPTH >69 pg/ml negative serum pregnancy test, serum calcium 8.0-10.5 mg/dl, phosphorus level <5.2 mg/dl, and serum albumin >3.0 g/dl.|
740685|NCT01138150|"Dates of recruitment - December 9 2010 through January 22, 2013.
~Types of location - Neurology Headache Clinic, Internal Medicine Clinics, Gynecology clinic; study flyers placed in the medical offices , Johns Hopkins Community Physicians sites, academic institutions and wellness centers."|
740686|NCT01138124|Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.|"Actual number of patients may be less, as it is possible for a patient to be represented in more than one of the four arms (See Participant Flow: Overall Study Table) because of the risk set sampling."
747691|NCT00769015|Subjects were recruited from July 2009 through Feb 2013 from a large, private retina practice.|
740689|NCT01138046||Six participants who met the eligibility criteria were enrolled into Phase I of the study. These 6 participants continued treatment into Phase II of the study, into which an additional 6 participants were enrolled. A total of 12 participants were followed until death or withdrawal from the study.
740690|NCT01138007|A total of 572 participants were enrolled in the study; however, 3 of these participants were mistakenly registered and were not randomized to study treatment.|Participants who met the inclusion criteria enrolled in the 1- to 2-week Run-in Phase before entering the 8-week Treatment Phase, followed by the 2-week Follow-up Phase. In the Run-in Phase, the previous/existing prohibited medications administered were washed out, and participants' clinical symptoms were carefully monitored.
740691|NCT01137890||
740692|NCT01137812|This study evaluated the efficacy and safety of canagliflozin compared with sitaglitin in patients with type 2 diabetes mellitus with inadequate control, despite treatment with metformin and sulphonylureas. The study was conducted between 30 June 2010 and 09 March 2012 and recruited patients from 140 study centers located in 17 countries worldwide.|A total of 756 patients were randomly allocated to the 2 treatment arms in the study. 755 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and the safety analysis set.
740693|NCT01137786||
740694|NCT01137773||
740695|NCT01137682||One hundred ninety-eight patients were randomized and 5 patients in CORE and 1 patient in extension did not receive any study treatment
740696|NCT01137604|A total of 173 subjects were screened and of those, 152 subjects were deemed eligible, and 151 received study treatment.|
740697|NCT01137578|Study initiated: 28 February 2011; Study Completed: 10 May 2013. Patients with central venous catheter (CVC) in-place or planned were enrolled. The Study was diagnostic for venous thromboembolism (VTE) and was non-therapeutic.|151 participants enrolled; 134 had at least one study-related diagnostic imaging procedure completed or partially completed; 17 enrolled but not identified to a cohort and no study-related imaging procedures performed: Adverse event (2), withdrew consent (1), lost to follow up (1), poor/non-compliance (1), no longer met criteria (3), other (9).
740698|NCT01137539|Recruitment period: October 2008-May 2009 at medical practice|
740699|NCT01137474|"This study was originally designed with 2 additional double-blind treatment arms, dapagliflozin 2.5 and
~5 mg, but randomization of new patients into these arms stopped with implementation of Protocol Amendment 8
~on 1-11-11. Patients randomized to dapagliflozin 2.5 or 5 mg remained on their blinded medication until study completion."|Of 2996 participants enrolled, 944 were randomized and received double-blind treatment.
740700|NCT01137435|The Post Marketing Surveillance period was from 23 June 2009 to 22 June 2015 at 7 clinic centers in South Korea.|Case report forms were retrieved from a total of 687 participants during the 6 years post marketing surveillance study; 659 participants were included in the safety analysis.
740701|NCT01137396||
740702|NCT01137370|from April 2010 to March 2011, at Seoul National University Hospital, a tertiary referral hospital in Seoul, South Korea|Korean who had been abroad for longer than 1 month during the previous year and non-Koreans were excluded from both arms.
740703|NCT01137292||
740704|NCT01137110||All patients enrolled were assigned to a treatment group.
740705|NCT01137071|This was a Brazilian, multicentric clinical trial. From April 12, 2011 to October 31, 2013 a total of 37 patients were screened for this study, of whom 29 received at least one dose of the investigational product and 07 were considered noneligible.|Patients were considered included in the study on the day of the first investigational product administration after investigator assured that patients met all the inclusion criterions and none of the exclusion criterions.
740706|NCT01137032||
740707|NCT01137006||A completed participant (pt) finished the first 4 or 6 weeks of therapy or discontinued due to toxicity. Cohort (C)1A pts were treated sequentially. The next cohort started when all pts finished Cycle 1 of current cohort. Cohorts 1B-3B started if supported by C1A and C2A pharmacokinetic (PK) data and if maximum tolerated dose (MTD) not established.
740708|NCT01136967|A total of 298 participants were screened. Of these, 116 were screen failures and 182 received treatment (93 participants in Cohort 1 and 89 participants in Cohort 2).|
740709|NCT01136954|"Subjects who completed E2090-E044-312 (NCT00566254)Study 312 core study were invited to participate in this extension study."|
740710|NCT01136915||
740711|NCT01136876||
740712|NCT01136798||
740713|NCT01136785|In a 2:1 ratio (2 active CPAP: 1 sham CPAP), 22 eligible subjects who had completed baseline assessments underwent 1 week of in-laboratory active CPAP or sham CPAP therapy and completed the post-treatment assessments. Two subjects assigned to the CPAP group and one subject assigned to the sham group were excluded for protocol violations.|
740714|NCT01136772||
740715|NCT01136746||
740716|NCT01136733||A total of 173 participants were enrolled into the study and treated.
740717|NCT01136655|This multicenter study was conducted in Europe and the United States between 7 October 2010 and 3 January 2012.|The study consisted of a screening visit, an enrolment visit, a 1- to 2-week run-in (standardization) period, randomization at Visit 3, and 4 further visits (Visits 4-7)separated by approximately 7-day (minimum 3 days; maximum 14 days) wash-out (stabilization) periods. Subjects received 1 of 5 single-dose treatments at Visits 3-7, in random order.
740718|NCT01136486|Patients with a documented history of head trauma ranging from mild to severe, with and without complaints of pain presented to Staten Island University Hospital over a 1 year period were considered for this study.|
740719|NCT01136408|Eight patients were randomised but not treated with study drug, hence resulting in 174 patients as enrolled and 166 who were actually treated.|
740720|NCT01136382|This multicenter study was conducted in Bulgaria, Hungary, Latvia, Poland, Slovakia, South Africa, and the United States between 07 August 2011 and 05 April 2013.|The study consisted of a screening visit (Visit 1), an enrollment visit (Visit 2), a 7- to 21-day run-in/qualification period, a randomization visit (Visit 3), and 6 further weekly visits during a treatment period of 6 weeks. A telephone follow-up was conducted approximately 2 weeks after the final study visit.
740721|NCT01136356|The study site was an in-patient research-based clinic affiliated with the Johns Hopkins University School of Medicine.|
740784|NCT01132820|The study was activated on 6/7/2010 and suspended to accrual on 3/7/2011. The study reopened on 11/21/2011 and closed on 4/30/2012.|
740785|NCT01132755||
740722|NCT01136291|A randomized controlled clinical trial was conducted with pregnant women seen at the Prenatal Outpatient Clinic of the Women's Integral Healthcare Center (CAISM-UNICAMP) from August 2008 to August 2010.|The entire study protocol was explained to these women and a written informed consent term was obtained. Subsequently, the women were randomly assigned to two groups: 1) one exercised under supervision and received home exercise counseling (study group) and 2) the other followed the prenatal routine of the service (control group).
740723|NCT01136226|Patients were enrolled from 2003-2008 at a medical office setting|
740724|NCT01136174||
740725|NCT01135992|The trial was conducted at 27 sites in the United States of America (U.S.)|The trial was conducted on subjects with type 2 diabetes mellitus currently treated with IGlar once daily (OD) and oral antidiabetic drug (OAD) therapy.
740726|NCT01135914|"A total of 239 patients were enrolled in the study. An additional 2 patients were enrolled but were removed from the database because consent was not signed in accordance with GCP principles."|3 treatment arms: Group C - laser photocoagulation per ETDRS guidelines, Group B - ranibizumab intravitreal injections (3 monthly injections during loading phase, and subsequent treatments per protocol-defined criteria), or Group A - combination therapy, where decisions to treat with laser were independent of decisions to treat with ranibizumab.
740727|NCT01135537||
740728|NCT01135524|02-Apr-2004 (first subject first visit, core study) to 05-Aug-2005 (last subject last visit, extension phase), in 82 sites in the US; 59 sites randomized at least 1 subject.|Subjects with moderate to severe osteoarthritis (OA) pain who required opioid analgesia; completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase and completed all visits of the double-blind phase off study drug were eligible for the extension phase.
740729|NCT01135511||In this study, during the 2-week run-in period, enrolled participants were administered artificial tears 4 times daily after signing informed consent.
740730|NCT01135498||
740731|NCT01135420|Patients were recruited from inpatient psychiatry settings.|
740732|NCT01135381|"Patients were recruited from multiple clinical units in a large tertiary care clinical facility in Alabama with a geographically wide, mostly rural catchment area.
~Recruitment period: 2/2010 to 3/2012."|757 were discharged prior to completing their enrollment, and 304 did not meet other inclusion criteria. Thus, a total of 511 patients were enrolled and randomly assigned to groups.
740733|NCT01135368|Participants took part in the study at 38 investigative sites in Germany from 18 June 2002 to 24 September 2008.|Participants with a historical diagnosis of Gastro Esophageal Reflux disease (GERD) received treatment with Lansoprazole at the usual dosage.
740734|NCT01135329||
740735|NCT01135186|9 women with moderate to severe gastroparesis were enrolled at medical clinic.|
740736|NCT01135134||
740737|NCT01135069||
740738|NCT01135017|Recruitment initiated in July 2010 was discontinued in December, 2011 due to significantly lower than planned enrollment with no feasibility to complete the trial within reasonable, meaningful timelines and despite a protocol amendment that extended the recruitment period and reduced the sample size from 424 to 286 participants.|"After signature of the informed consent and after eligibility was confirmed, group assignment was made at site in a 1:1 ratio using a treatment code list generated centrally by Sanofi. Participants were considered as randomized as soon as the assignment was made.
~Only 112 patients were randomized at 62 sites."
740739|NCT01134952||
740740|NCT01134939||
740741|NCT01134900|We performed a randomized, controlled trial during June 1, 2010 through August 31, 2010 at a large academic, tertiary care facility. We included all admitted adult patients who experienced a 0.5 mg/dl change in serum creatinine over 48 hours following an active, recurring order for one or more targeted nephrotoxic or renally cleared medications.|Patients who were dialyzed prior to the first serum creatinine change event or identified as a dialysis patient through a dialysis flag order, in addition to those admitted to renal transplant, liver transplant, or nephrology services were excluded.
740742|NCT01134887|Ten physicians and 20 Veterans were recruited into the study at the Roudebush VA Medical Center in Indianapolis, Indiana. The 20 Veterans were patients in the panels of the ten participating physicians. Four patients did not complete the protocol reducing the overall number of completers to 26.|
740743|NCT01134783||
740744|NCT01134731|Participants were male and female, aged 19- 65 years old, recruited as outpatients from the general public.|
740745|NCT01134705|A total of 675 patients were screened and 574 patients were enrolled in the study and participated in the Run-in Period. Of the 574 enrolled patients, 474 were randomized to study treatment.|During the 7 to 21 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their twice daily allergic rhinitis symptoms to determine eligibility for randomization.
740746|NCT01134627||One out of 305 participants was randomized by mistake and did not receive study medication.
740747|NCT01134614|Participants were enrolled from ECOG member institutions between December 28, 2010 and July 28, 2011.|
740748|NCT01134575|Recruitment period: June 2010 to October 2012|
740749|NCT01134562|This study was conducted at 1 center in Australia and 2 centers in the United States from 07 September 2010 to 02 April 2011.|Cohorts 1-3 were conducted with a two-period crossover design. Each cohort enrolled four participants randomized 1:1 to etelcalcetide followed by placebo or placebo followed by etelcalcetide. Cohorts 4 and 5 followed a parallel group design. Within each cohort eight participants were randomized 1:1 to receive placebo or etelcalcetide.
740750|NCT01134549|This study was conducted at one clinical center in Australia.|The study included 4 cohorts: 0.5 mg, 2 mg, 5 mg and 10 mg. Eight participants were enrolled into each cohort and were randomized 6:2 to receive etelcalcetide or placebo.
740751|NCT01134510||
740752|NCT01134393||This was a prospective, single-arm, open-label, uncontrolled, multi-centre, international trial. Whilst 542 patients were enrolled, 502 entered the study. Since one patient refused to take study medication, only 501 patients were treated. The Full analysis set (FAS) consisted of 494 patients and this is the basis of most data presentations.
740786|NCT01132690||
740924|NCT01124643||"Screening details:
~Thirty-five of the 40 subjects who completed the parent study (Study TKT028 [NCT00864851]) were enrolled in this extension study."
740925|NCT01124617||
740926|NCT01124604||
740753|NCT01134328|Subjects were recruited from two sites in the US.|There were 83 subjects enrolled, 12 subjects discontinued, and 71 subjects completed the study. Participant flow and baseline characteristics are presented for the 83 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-150 Combo, AC-150A 0.1%, AC-150B 0.005% or Vehicle
740754|NCT01134315||
740755|NCT01134276|Total 211 patients underwent pancreatoduodenectomy after preoperative biliary drainage at Seoul National University Hospital.|144 patients and 68 patients were intended to be treated with ERBD/ENBD and PTBD, respectively. Among 144 patients, 39 patients were switched to PTBD due to a procedure failure. Finally, 104 and 107 patients were treated with ERBD/ENBD and PTBD, respectively. Clinical outcomes were compared on the basis on the final drainage method
740756|NCT01134263|Study participants were enrolled from 05 October 2010 to 26 November 2010 at 8 study sites in Australia.|A total of 715 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled in the study.
740757|NCT01134198||58 participants signed consent and were enrolled into the trial. Only 32 entered the randomized phase of the study with only 29 being assigned to one of the treatment arms.
740758|NCT01134107||
740759|NCT01134081|44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.|
740760|NCT01134055|This was a multicenter, randomized, parallel-group, double-masked eye drops, and active-controlled study from 01 June 2010 to 05 October 2012. The study was conducted at 77 sites in 9 countries from North America, Europe, Australia and Japan.|A total of 510 participants were randomized for the study. After a 1-2 week screening period, participants entered a 52-week treatment period. There were 449 screen failures in this study.
740761|NCT01134042||Participants (par.) meeting eligibility criteria at the Screening visit entered a 4-week Run-in Period for completion of Baseline (BL) safety evaluations and to obtain BL measures of asthma status. Par. were then randomized to a 24-week Treatment Period. 1206 par. were screened, 587 were randomized, and 586 received >=1 dose of study treatment.
740762|NCT01134016|A total of 13 patients were enrolled and treated: 1 patient each received 50, 100, 200, and 300 mg, 4 patients received 450 mg, and 5 patients received 600 mg. The recruitment period is from 19 Jan 2010 to 13 Dec 2012 in list two medical center, Taiwan.|This was an open-label, non-randomized, dose escalation, PK study to determine the MTD and DLTs and to explore the PK, safety/tolerability, and preliminary efficacy profiles of antroquinonol.
740763|NCT01133977|A total of 16 participants were enrolled in the Phase 1b portion of the study; all 16 participants received study treatment. A total of 82 participants were randomized in the Phase 2 portion of the study and a total of 81 participants received treatment. In the Darcarbazine arm, one participant withdrew consent prior to receiving study treatment.|
740764|NCT01133860|Patients enrolled between January 2009 and January 2010 as outpatients in medical clinic|
740765|NCT01133847||
740766|NCT01133821|adult outpatients with BD II depression recruited from provider referrals, advertisements, and research registries from 2010-1015|Participants who met eligibility criteria but were on psychotropic medications at time of informed consent were gradually tapered off medications and re-evaluated to ensure that they still met eligibility criteria following one week off of all medications prior to randomization
740767|NCT01133756||Approximately, 100 participants were planned to be enrolled (10-20 in Phase 1b and 80 in Phase 2) but only 7 participants were enrolled.
740768|NCT01133704|Participants were randomized between May 2000 and March 2003 across 24 clinical trial sites.|Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
740769|NCT01133678||
740770|NCT01133665||
740771|NCT01133639|18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed.|
740772|NCT01133626|A total of 139 patients were screened and 128 patients were enrolled in the study and participated in the Run-in Period. Of the 128 enrolled patients, 107 were randomized to study treatment.|During the 7 to 14 day Run-in Period (prior to randomization), participants self-administered a single-blind placebo nasal aerosol once daily in the morning.
740773|NCT01133522|This study enrolled hypercholesterolemic adults receiving stable statin therapy (7 cohorts: 5 on low-to-moderate-dose statins, 1 on high-dose statin therapy, and 1 with heterozygous familial hypercholesterolemia (HeFH) (score ≥9, World Health Organization criteria). First patient enrolled 28 June 2010. Last patient enrolled 24 June 2011.|Participants receiving low-to-moderate-dose statins were randomized 1:3 to placebo or evolocumab and sequentially assigned to 1 of 5 dose-escalation cohorts. The high-dose statin and HeFH cohorts were randomized 1:3 and 1:2 respectively to placebo or evolocumab. Placebo participants were pooled for the 5 dose-escalation cohorts.
740774|NCT01133418||
740775|NCT01133405||The study consists of 2-parts. Part A was a cross-over study and was conducted in 2 alternating cohorts (Cohorts A and B). Part B was a single-dose, single period study in 2 cohorts (Cohorts C and D). All doses were administered in the fasted state, unless otherwise indicated. Each oral dose was followed by a washout period of at least 14 days.
740776|NCT01133392||41 participants were enrolled into the study. 3 participants discontinued due to subject decision prior to receiving treatment.
740777|NCT01133379||
740778|NCT01133288|Participants were recruited from July 2009 until May 2010. Only 7 participants were enrolled. None of the participants completed the study. Funding was never received from the study sponsor, so the study was terminated.|Of 7 individuals who enrolled in the study, 2 passed screening and were found to be latex allergic. Funding was never received from the study sponsor and the study was terminated. The 3 month trial of Yulex gloves was not started with any of the participants, so no intervention data is available.
740779|NCT01133275|Participants were recruited at Moffitt Cancer Center and Shands Cancer Hospital at the University of Florida from 4/28/2010 through 8/13/2013.|
740780|NCT01133171||
740781|NCT01133158||
740782|NCT01133067||
740783|NCT01132846||
740787|NCT01132664|72 patients (pts) were enrolled: 18 in ph lb, 53 in ph ll, including 8 from ph lb, with 45 new pts in ph ll & 9 in the brain metastasis (BM) cohort. Of the 72 pts, 1 in ph lb & 3 in phase ll, did not receive Burparlisib, only Trastuzumab. Therefore, 68 patients (17 in ph l, 42 in ph ll, 9 in BM cohort) were treated with buparlisib + trastuzumab.|"Primary outcome measure for BM cohort was MTD/RP2D which was not reached/established due to premature termination of the study.
~Objective Response Rate (ORR), Disease Control Rate (DCR), Clinical Benefit Rate (CBR) & Progression Free Survival (PFS)were not calculated for the BM cohort either."
740788|NCT01132651||
740789|NCT01132612||Participants continued their regimens as assigned in CAIN457A2211 (NCT00941031) and were enrolled into one of the following: fixed time interval regimen (FI), treatment at start of relapse regimen (SR) or open-label (OL). There were no more placebo treated patients at the end of the core. Therefore, there is no placebo arm in the extension.
740790|NCT01132547||
740791|NCT01132508||
740792|NCT01132495||Participants were randomized to Cohort A if at least one stenoses had an FFR value of <=0.80. Participants with FFR >0.80 were treated according to local practice and were randomized to study follow-up / no study follow-up in Cohort B. Therefore, participants are either in cohort A or cohort B (not both).
740793|NCT01132482||
740794|NCT01132378|Forty consecutive patients who underwent staged bilateral TKA (within no more than 7 days)were assessed at 2,6, 12 weeks and 6,12, and24 months postoperatively|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
740795|NCT01132326||
740796|NCT01132313||This trial was conducted in 4 parts, each consisting of randomised, open-label treatments.
740797|NCT01132144|The recruitment occurred from July 2010 to March 2012 in the fertility clinic of an university hospital.|All women that fulfilled eligibility criteria were invited to participate. Those who agreed were included. No women was excluded.
740798|NCT01132118|107 potentially eligible RA patients were screened during 2010-2011. 7 subjects did not meet inclusion/exclusion criteria at screening and 63 declined participation.|37 subjects were initially consented, 7 withdrew consent before randomization. Thirty patients were randomized. Five patients withdrew consent after randomization and two patients stopped participation in the study due to non-serious adverse events.
740799|NCT01131884|A 57 year old T4 paraplegic was recruited while he was going through rehabilitation at Strong Memorial Hospital inpatient rehab unit. This patient was recruited and signed consent on 8/05/2011.He underwent lab work and dexa scan per protocol and on completion of the investigation on September 19, 2011 he started the treatment(Fosamax vs. Placebo).|Recruitment beyond one patient was not possible due to A. surgeons unwillingness to initiate Fosomax treatment for fear of wound healing. B. The eligible patients' reluctance to participate in the study. C. Given the length of time it took to enroll one, it is not feasible to complete the study with required # in the protocol in the next few years
740800|NCT01131676|Patients randomised to treatments in 1:1:1 ratio.|Randomisation stratified by:BMI at randomisation(<30/≥30 kg/m2),HbA1c at screening (<8.5%/ ≥8.5%);geographical region(North America including Australia and New Zealand,Latin America,Europe,Africa,Asia);renal function at screening (normal:eGFR ≥90 mL/min, mild impairment:60 mL/min ≤ eGFR ≤89 mL/min, moderate impairment:30 mL/min ≤ eGFR≤59 mL/min).
740801|NCT01131585|Participants did not complete study due to early termination. Study was terminated because of drug approval.|
740802|NCT01131520||
740803|NCT01131507|Participants who completed previous study PR-011 (NCT01100606) and consented to continue treatment with EUR-1008 (APT-1008) 3,000 lipase units were enrolled in this study.|
740804|NCT01131494|Consecutive patients from Movement Disorders Ambulatory of Federal University of Bahia in Brazil with idiopathic Parkinson disease (IPD) and complaint of dysphagia, from March 2009 to June 2010, were invited to participate.|Patients with severe dysphagia who needed others interventions (for example: management of food consistency, alternative way of feeding) were excluded. During the study, subjects with absence in three sessions of exercises were excluded from the study and sent to Ambulatory of Speech and Deglutition Disorders at Federal University of Bahia.
740805|NCT01131455||
740806|NCT01131312||
740807|NCT01131299|The recruitment occurred at the Clinical Center, NIH.|103 screened participants, 75 completed the study, 14 subject withdrawals and 14 subjects who did not meet inclusion criteria
740808|NCT01131260||
740809|NCT01131182||Of the 1147 participants enrolled in the study, 1066 participants were randomized to treatment.
740810|NCT01131130|There were 120 participants enrolled in this bilateral eye, three-period crossover study at four investigative sites in the United States (US). All participants were adapted wearers of soft contact lenses. The first participant was enrolled in the study on 5/10/2010 and the last participant exited the study on 6/10/2010.|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Of the 120 participants enrolled 2 were ineligible at baseline and 2 discontinued following dispensing of lenses. 116 participants completed the study.
740811|NCT01131104||"Study Set were enrolled participants who met inclusion/exclusion criteria and physician-diagnosed Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)known date of onset.
~Adjudication-Confirmed NAION Set were confirmed participants (by adjudication committee) with inclusion/exclusion criteria and physician-diagnosed NAION known date of onset."
740812|NCT01131078||
740813|NCT01131065|"Fifteen subjects (newly liver transplanted due to HBV induced liver disease) were screened in the study, all received the study medication, and all completed the clinical study.
~First subject enrolled - 26 July 2010 Last subject completed - 16 June 2014"|
740814|NCT01131052|Recruitment took place at Emory University-Wesley Woods Campus between March 2011 through December 2013.|
740815|NCT01130974|200 Asian participants (400 eyes) who were adapted wearers of soft contact lenses were enrolled in this 1-month study at approximately 10 investigative sites in Asia and the United States. First participant was enrolled 4/12/2010 and last participant exited the study 08/09/2010|Of the 200 participants (400 eyes) enrolled and dispensed lenses, 172 participants (344 eyes) completed the study
740816|NCT01130896||
740817|NCT01130883||
740818|NCT01130844||
740821|NCT01130597||Eligible participants were ≥ 18 years old, had a history of chronic HF, were clinically indicated to initiate spironolactone therapy, had a serum potassium measurement of 4.3 - 5.1 mEq/L at screening and baseline, had CKD (eGFR < 60 mL/min/1.73 m2 at screening), and were taking one or more HF therapies (ACEIs, ARBs, or BBs).
740822|NCT01130532||This study consisted of 4 periods. Period I was a 4-week, as needed, run-in period. Period II was a 4-week, non-drug, wash-out period. Period III was a 12-week (Weeks 0-12), double-blind treatment. Period IV was a 4-week (Weeks 13-16), open-label treatment extension. Only participants completing Period III were eligible to continue into Period IV.
740823|NCT01130493|Date first patient enrolled: March 22, 2011 Date last patient completed: January 12, 2012|Following enrollment, all subjects were converted from stable doses of CLE to IPX066 prior to randomization. Following dose conversion, subjects were randomized into one of the two treatment sequences.
740824|NCT01130337||Screening period comprised of 35 days. A total of 136 participants were included in the study, of which 36 participants were enrolled and 100 participants discontinued due to screening failures. Abbreviation of AE= adverse event.
740825|NCT01130272|9 patients were randomized more than once, enrolling at a second (or third) site after discontinuation from the first site. Safety data was analyzed according to the highest dose received. Safety Analysis Set: Highest Dose Level in the Participant Flow reflects the reassignment of patients randomized more than once to the highest dose level arm.|807 patients were randomized in the trial. 18 of these patients were enrolled at a site terminated by Furiex, reported to the FDA for potential scientific misconduct, and were excluded from all datasets. All Randomized Patients=789 patients.
740826|NCT01130168||
740827|NCT01130103|Recruitment dates: December, 2004 to February, 2009. Location: Anxiety Disorders research clinic.|
740828|NCT01130051||
740829|NCT01129960|"Fifty nine (59) clinical sites in 10 countries
~Study period:
~Date of first admission: 2010.12.06 Date of last visit: 2012.04.24"|
740830|NCT01129921|Recruitment occurred 4-19-10 to 7-28-10|Randomization occurred in blocks of four. After Week 6 post-treatment and prior to Week 12, Sham arm participants were allowed to have the mild decompression procedure with bone and tissue removal if they chose to have it.
740831|NCT01129882||Participants with a current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, who completed the open-label extension Study 31-08-248 (NCT00731549) (completed Study 248 Study Completion visit, Week 52).
740832|NCT01129778||5 participants withdrew after providing their informed consent and before beginning their participation in the study.
740833|NCT01129765|The study was performed in a pediatric ambulatory clinic in July and August of 2009. The clinical coordinator identified patients as they presented to the clinic if they met inclusion criteria and informed consent was obtained before patient entry.|
740834|NCT01129622|16 women over age 40 on hormone therapy were recruited. No previous abnormal breast imaging.|
740835|NCT01129609||
740836|NCT01129583|Patients were recruited from the orthopaedic upper extremity trauma clinic of the primary investigator. The recruitment period was 49 months in length, from 11/2003 through 11/2007.|Of the 59 patients assessed for eligibility, 41 patients were excluded based on the listed inclusion/exclusion criteria.
740837|NCT01129557||
740838|NCT01129531||There were two Treatment Cycles in this study 12 weeks apart. In Treatment Cycle 1 participants were randomized to AGN-214868 3.25 μg, AGN-214868 16.25 μg or Placebo. In Treatment Cycle 2 participants were re-randomized to AGN-214868 3.25 μg, AGN-214868 16.25 μg or Placebo.
740839|NCT01129440||
740840|NCT01129336|80 patients were screened. 44 patients received treatment.|
740841|NCT01129284|15 subjects with resistant glomerular diseases were enrolled and treated with ACTH gel (80 units subcutaneously twice weekly) for 6 months.|
740842|NCT01129245||
740843|NCT01129206|This was a phase II single-arm, open label trial performed at The Ohio State University James Cancer Hospital.|
740844|NCT01129141|Potential participants (candidates) were referred to the study by fliers posted at U.S. VA and Military sites. Civilians were not actively recruited for the study, but some discovered it via clinicaltrials.gov or by word of mouth. Candidates contacted the study team and were screened for potential eligibility over the phone.|Candidates must have had a hearing test within the previous 2 years. They were required to get hearing aids if recommended and wear them for at least 1 month before entering the study. Consented candidates were assessed for phone counseling suitability. If current suicidal ideation (SI) was expressed, the subject was excluded from the study.
740845|NCT01129128|Healthy adult volunteers enrolled from May 2010 through March 2011|
740846|NCT01129115||
740847|NCT01129102||
740848|NCT01129011|A multi-center US study in which 70 sites recruited subjects between September 2007 and September 2008|Screening for eligibility and wash-out of restricted medications
740849|NCT01128972|Participants were recruited at the clinical site.|Two days, prior to each treatment visit ,participants used a fluoride- free dentifrice twice daily to avoid any carry over effect.
740850|NCT01128959|The patients were recruited through physician referrals and/or recruitment methods at hospitals and clinics. Advertisements were used by 5 sites.|
740851|NCT01128946|Participants were recruited at the clinical site.|Two to three days before the start of each treatment period, participants received a professional dental cleaning of their natural teeth, then brushed with the study wash out toothpaste and toothbrush.
740852|NCT01128894||Eligible participants entered into 2 weeks of Prescreening and Screening; 4 weeks of Run-in/stabilization; a 32-week Treatment Period for evaluation of efficacy and safety and 8 weeks of post treatment Follow-up. A total of 1764 participants were screened, 841 were randomized and 812 received at least one dose of study treatment.
740853|NCT01128842||
740854|NCT01128829||
740855|NCT01128738||This study consisted of a Screening Phase (1- to 2-week period), the First Treatment Phase (16- to 40-week period after first treatment), and the open-label Second Treatment Phase (16- to 24-week period after reinjection). All participants were observed until Week 40 after the first treatment irrespective of whether they received reinjection or not
740927|NCT01124448||
743987|NCT00958360||A total of 2,051 patients were screened, of whom 1,728 were excluded (1,706 ineligible per chart review and 22 ineligible after screening).
740856|NCT01128621|The study was conducted at two study centers in the United States from 23 November 2009 up to 12 April 2010. The study consisted of open label Part A and single-blind Part B. Total 6 participants were randomized in Part A whereas total 67 participants were randomized in Part B.|
740857|NCT01128595||Participants meeting all of the inclusion criteria and none of the exclusion criteria during the Screening Visit, conducted 14-42 days prior to the first dose of study medication, entered a 14-day Run-in Period. Participants were then randomized to 4 Treatment Periods, each lasting 21 days and separated by a nominal washout period of 21-35 days.
740858|NCT01128569|Participants were screened within 42 days of the first dose, conducted over 2 days (not consecutive days). During this time, a methacholine challenge and an allergen challenge test were performed. Participants meeting all inclusion criteria and none of the exclusion criteria were randomized to 3 study treatment periods, each lasting 28 days.|This study was a multi-center, randomized, double-blind, placebo controlled, three-period crossover study in mild asthmatic male and female participants. Following the Run-in period, participants were randomized to 1 of 6 treatment sequences of placebo, FF 100 micrograms (µg) once daily (OD), and FF/VI 100/25 µg OD.
740859|NCT01128543||
740860|NCT01128426||
740861|NCT01128413|Patients screened and study performed in the ED from July 2010 to November 2013.|
740862|NCT01128400|May 2010- August 2011 recruited by local posters and media advertising via the Washington University Research Participant Registry.|40 subjects signed consent form and were screened for rs1761667 genotype and three groups (i.e., AA, AG and GG) matched in age and BMI were invited to participate on the taste test.
740863|NCT01128387|Participants were recruited from the University of Wisconsin Hospital and Clinics between 2010 and 2013.|
740864|NCT01128361||
740865|NCT01128296||"35 enrolled
~2 participants withdrew prior to treatment
~1 participants removed from protocol after the first dose of gemcitabine due to cerebrovascular accident unrelated to study drug
~1 patient removed from protocol due to allergic rash likely related to gemcitabine
~31 participants remained to receive gemcitabine + HCQ treatment"
740866|NCT01128270|Subjects were recruited using an ad approved by the Institutional Review Board (IRB) and by undergoing a screening exam to determine eligibility.|There were 27 total participants, with 4 eligible sessions (periods) for each, with the order to be randomized. As per CT.Gov instructions, the periods are identified by treatment rather than order.There were no planned comparisons between the arms of this pharmacological study. Withdrawals entered but did not reach baseline.
740867|NCT01128244||
740868|NCT01128192|Participants were healthy men aged 18-50 years with a body mass index (BMI) ≤25 kg/m2 who came to the VA San Diego Healthcare System Metabolic Research medical clinic. Recruitment occurred between August of 2009 until March 2010.|Participants were excluded if they had a family history of diabetes or a baseline diagnosis of impaired glucose tolerance.
740869|NCT01128179||
740870|NCT01128153|Participants were recruited to the study from 35 centres in 6 countries (Australia, United Kingdom, Canada, Korea, India and Thailand). Participants were recruited between June 2010 and December 2010.|Participants were screened over 2 week period. 383 participants enrolled; 126 excluded (11 declined, 114 did not meet eligibility criteria, 1 lost to follow up).
740871|NCT01128114||
740872|NCT01128049||
740873|NCT01127763|From June 2010 to July 2012, 25 patients were enrolled from New York University Medical center and its affiliated hospitals.|
740874|NCT01127737|Subjects were recruited from Northwestern University's kidney transplant recipient population. Participants were returning for routine care to their nephrologists 1 to 1.2 years or 3 to 7 years after transplantation.|
740875|NCT01127659||
740876|NCT01127646||
740877|NCT01127633|Participants who completed one of the feeder studies (Study LZAM (NCT00905372) or Study LZAN (NCT00904683)) were enrolled in this study.|
740878|NCT01127607|Participants were recruited by direct advertisement as well as from referrals from mental health and medical providers.|Participants first stabilized on LDX in 3 week open label trial starting at 30mg + increasing by 20mg/week until optimal dose was found. Those unable to tolerate LDX or not responsive to it were discontinued. 38 enrolled; 8 dropped out due to adverse events + 3 were lost to follow up in med phase, leaving 27.
740879|NCT01127581|Pregnant women who required to be induced were recruited at 35 sites in the US.|
740880|NCT01127503||
740881|NCT01127438||
740882|NCT01127321||Due to premature termination of the study, planned treatment cohorts, MEDI-570, 3 milligram (mg) and MEDI-570, 10 mg, were not administered. A total of 17 participants were randomized in the study. An additional 27 participants were screened but not randomized in the study.
740883|NCT01127256|This study was recruited at 12 centers in Korea during the period of May 2006 to May 2009.|
740884|NCT01127165|This study was recruited at 11 centers in Korea during the period of March 2006 to July 2009.|
740885|NCT01127139||
740886|NCT01127087|Participants were recruited from the Mayo Clinic, Rochester, Minnesota.|7 subjects were enrolled on the Idiopathic arm; of these 2 did not complete baseline collections, and 3 didn't qualify, so these 5 were excluded. 15 subjects were enrolled on the RYGB arm; of these, 3 never started the study and 2 did not qualify, so these 5 were excluded.
740887|NCT01127061||
740888|NCT01126957|107 participants were consented for the study. 103 completed.|We know that 107 participants had enrolled as of February 2008 and that 4 were terminated by the PI as not eligible. 103 were noted to have completed. However, the PI left the institution without making available any results or analyzed data.
740889|NCT01126879|The study opened on October 21, 2010 with an accrual goal of 30 patients with firs the patient enrolled March 3, 2011. The study was designed as a randomized blinded drug/placebo study but was amended to a single arm drug study and accrual reduced to 18. Study closed permanently on May 28, 2014 due to low accrual with 12 patients treated on study.|Patients entered the study and were treated in a double blinded fashion with a ration of 2:1 Genistein:Placebo. Unblinding occured if it was medically necessary otherwise blinding was maintained until the time of data review.
740890|NCT01126801||
740891|NCT01126723||
740968|NCT01122160||Discrepancy between actual enrollment and number of participants in participant flow module is due to enrolled participants no longer meeting exclusion criteria (i.e., inability to swallow capsule).
740892|NCT01126671|Subjects were recruited from the Boston Children's Hospital (BCH) Adolescent Medicine Outpatient Program and from the community via flyers, internet postings, and newspaper advertisements. Enrollment began September 1, 2008 and ended March 18, 2011.|"Healthy adolescents, ages 11-19 years, were eligible if clinically healthy, likely to comply with treatment, and not vitamin D deficient.
~Fifty-six patients were enrolled, and two patients were randomized to a treatment group but did not complete a baseline visit and therefore are not included in the analysis."
740893|NCT01126619||
740894|NCT01126593|Principal investigator recruited patients in clinic.|If patient met the inclusion criteria and agreed to participate, they were given the consent to sign and were randomized into the trial.
740895|NCT01126580||
740896|NCT01126541||
740897|NCT01126437||This table summarizes study treatment disposition and reasons for discontinuation of study medication. Deaths that caused discontinuation from trial medications are included in AEs. Lost to follow-up indicates status at time of discontinuation of trial medication. Vital status was ascertained for 99.7% of patients.
740898|NCT01126424||
740899|NCT01126359||
740900|NCT01126268||
740901|NCT01126099||
740902|NCT01126060||
740903|NCT01125930||
740904|NCT01125917|Study dates: 17-Jun-2004 to 23-Sep-2005 at 52 medical/research sites in the United States participated in the extension study.|Subjects who completed all visits of the 12-week double-blind phase on study drug as well as subjects who both discontinued study drug due to lack of therapeutic effect in the double-blind phase and completed all visits of the double-blind phase off study drug were eligible for enrollment in the extension phase.
740905|NCT01125813|Participants were enrolled at 11 European sites beginning June 2010 and completing in January 2012.|36 participants were enrolled and screened. 4 were screen failures. Therefore, 32 of the 36 enrolled were exposed to investigation product.
740906|NCT01125800|The study was conducted at 14 centers in 6 countries.|A total of 76 participants: 60 pediatric and 16 adult participants were enrolled in this study, of which 59 pediatric participants received sonidegib during the dose-escalation and expansion part (Phase I); 17 participants (1 child and 16 adults) received sonidegib in the Phase II.
740907|NCT01125774||"Participants were randomized to telcagepant 140 mg or placebo. Protocol deviation occurred in which 28 participants (called duplicate participants) were randomized at more than 1 study site (22 unique participants randomized in total 37 times to telcagepant and 12 times to placebo; 6 unique participants randomized in total 12 times to placebo)"
740908|NCT01125748||
740909|NCT01125722||
740910|NCT01125605|Physicians who were registered in the past with the treatment focus on central nervous system / psyche. The recruitment of the participating physicians was done by the field service of PASCOE.|It was an non-inteventional observational study with 3 visits.
740911|NCT01125566|This was randomised, active-controlled, open-label, parallel-group, 2 arm (2:1 ratio) trial in participants with metastatic human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer failing one prior trastuzumab treatment.|Participants were treated in the study until disease progression, undue toxicity, or withdrawal of consent. The cut-off date for RECIST-based efficacy was 08 Jun 2013; a second analysis (primarily for assessing Overall Survival (OS)) contains all data until final database lock (30 Jul 2018).
740912|NCT01125514||
740913|NCT01125202|Participants were recruited from 17 dialysis centers, from the 3 corporate chains, between September 2009 and September 2012. Of the 848 HD patients available, 257 were eligible, 191 consented, 185 provided baseline data, 179 were randomized, and 160 (89.4%) completed the final 16-week measurement assessment.|
740914|NCT01125189|Participants were enrolled at 64 sites in 11 countries.|A total of 558 participants were enrolled in this study, and 395 participants were randomized and treated.
740915|NCT01125176|Participants were accrued to the study at Weill Cornell Medical College between March 2012 and September 2013.|One participant was deemed ineligible for the study following the completion of the informed consent process.
740916|NCT01125163||
740917|NCT01125098|The recruitment process involved18 university/city hospital pulmonary departments. Patients selected were subjects hospitalized because of severe exacerbation of COPD (increased dyspnea, sputum volume, and sputum purulence according to Anthonisen criteria and/or respiratory failure) requiring antibiotic treatment.|
740918|NCT01124955|100 patients were recruited from the university hospital of the Federal University of São Paul (UNIFESP), from November 2009 to June 2010.|80 patients were randomized during the study.
740919|NCT01124916|The recruitment period was from November 2009 to August 2011 (21 months)|Following enrollment, six women withdrew prior to randomization and two women were lost to follow-up prior to randomization
740920|NCT01124864|Two patients who were ongoing at the data cut-off of 30-Jul-2013 are considered as 'completed' in this study.|
740921|NCT01124838|This study includes a Japan sub-study. A total of 261 adults with inactive non-infectious intermediate uveitis, posterior uveitis or panuveitis were randomized at 72 study sites worldwide; 229 participants at 62 study sites in Australia, Israel, Latin America, North America, and Europe (Main Study), and 32 participants at 10 study sites in Japan.|"Participants were randomized in a 1:1 ratio double-masked fashion using baseline immunosuppressant (IMM) usage as the stratification factor. Participants in the Japan sub-study were randomized in a separate stratum with no stratification by baseline IMM usage.
~Study completion is defined as meeting treatment failure or reaching study Week 80."
740922|NCT01124786|This was a multicenter, multinational study conducted at 98 medical centers in Europe, Australia, and the Americas. The first patient was randomized on 04-Aug-2010 and the last patient on 09-April-2012.|Eligible patients were randomized (1:1) to receive either gemcitabine elaidate or gemcitabine. The stratification factors in this model were Eastern Cooperative Group Performance Status (ECOG PS) (0 vs 1) and region (North America/Western Europe/Australia vs Eastern Europe vs South America).
740923|NCT01124734|This was a single center study conducted at Penn State Hershey Medical Center Cancer Institute. The study was carried out in the Cancer Institute outpatient clinic. Accrual was initiated 9/07/2011 and completed completed 04/28/2014. Participants remained on study for long term follow up. The study closed in July 2018.|Participants were excluded if they received any chemotherapy, hormonal therapy, immunotherapy, or radiation therapy within 1 month of entry to the study.
741089|NCT01116466||
741090|NCT01116440||
740928|NCT01124422||In the open-label 4-week run-in phase, participants received 18 micrograms Tiotropium (TIO) once daily. Participants completing this phase (n=255) were then randomized to receive either TIO+placebo or TIO+Fluticasone propionate/salmeterol combination DISKUS. The number enrolled in the protocol section reflects these 255 randomized participants.
740929|NCT01124370||
740930|NCT01124305|Patients were recruited at a suburban orthopaedic clinic setting between June 2010 and Sept 2011.|Patients were excluded if their medical insurance did not cover a leg CT scan or if there was any metal in their leg.
740931|NCT01124292|"Able-bodied subjects (groups A and B) were recruited by using local IRB-approved flyers, emails, and electronically distributed documents.
~Subjects with spinal cord injuries were recruited from the in- and outpatient departments of the Shepherd Center and the Rehabilitation Institute of Chicago.
~(May. 2010 - March. 2012)"|
740932|NCT01124188||
740933|NCT01124175||
740934|NCT01124162||
740935|NCT01124149||Although 639 subjects completed the Acute Phase, 167 were not eligible to enter the Maintenance Phase due to lack of efficacy and 2 others withdrew prior to entering the maintenance Phase and 1 was withdrawn per IVRS prior to entering the Mainenance Phase. Therefore, 469 subjects entered the Maintenance Phase.
740936|NCT01124097|"Eighty nine (89) clinical sites in 12 countries
~Study period:
~Date of first admission: 2010.09.28 Date of last visit: 2012.04.23"|
740937|NCT01124045|Patients were screened and recruited from 17 study centers located within the United States.|This reporting group includes all patients who were exposed to the study drug. One patient randomized to DUREZOL withdrew consent prior to receiving study medication.
740938|NCT01124006||
740939|NCT01123980|The trial was conducted at 35 sites in two countries: China (21 sites) and Japan (14 sites).|At the screening, eligible subjects entered the run-in period before being randomised. During the 3 week run-in period, subjects switched from insulin secretagogue to glimepiride. During the last 2 weeks, the total dose of glimepiride was kept at 4mg/day. Subjects continued their pre-trial metformin dose.
740940|NCT01123941|First subject enrolled: 03 MAY 2010 Last subject completed: 09 NOV 10 All subjects were enrolled at 1 center in Belgium|
740941|NCT01123928|Subjects were recruited from 32 outreach screening sessions in various villages and townships of Guangdong province from June 2010 to November 2010.|
740942|NCT01123889||
740943|NCT01123850||
740944|NCT01123655|October 1, 2009-September 30, 2015.|
740945|NCT01123642||A total of 345 participants were consented into the study, after which final eligibility was determined during the baseline assessment (see inclusion/exclusion criteria). Of the 345 enrolled, 309 met inclusion criteria and were deemed eligible for follow-up in the longitudinal study.
740946|NCT01123512||
740947|NCT01123395||
740948|NCT01123382||
740949|NCT01123356||
740950|NCT01123200||
740951|NCT01123161||
740952|NCT01123148||Of the 16 people consented, 2 were pilot subjects, not intended for inclusion in the final analysis. They helped to test the protocol and set-up for the planned data collection session to make sure that the instructions for future subjects were clear and that all equipment was working correctly.
740953|NCT01123083|This study was conducted across 73 centers in 10 countries (Belgium, Canada, Germany, Denmark, Spain, Finland, United Kingdom, Italy, Sweden, and United States of America) from 17 May 2010 to 09 March 2012.|A total of 179 participants (125 adults and 54 adolescents) were randomized in this study and included in safety and intent-to-treat (ITT) population.
740954|NCT01122927|This trial was conducted in 524 participants at 118 trial sites in the following 13 countries: Bulgaria, Croatia, Hungary, India, Malaysia, Philippines, Poland, Romania, Russia, Serbia, Taiwan, Ukraine, and the United States.|524 participants entered this trial (297 participants in the conversion phase and 510 participants in the open-label treatment phase). In the latter, 362 were de novo participants (283 participants entered into the conversion phase) and 148 rolled over from Trial NCT01149655.
740955|NCT01122901|Patients enrolled between April 2011 and May 2012 Patients enrolled in outpatient setting|
740956|NCT01122862|Participants were recruited at the clinical site.|Of 31 participants screened, 23 were randomized. 8 enrolled participants were excluded from trial before assignment to groups (3 did not meet the study criterion; remaining 5 were excluded due to other reasons).
740957|NCT01122849|Participants were recruited at two centers in USA.|A total of 97 participants were screened for this study, out of which 61 participants were randomized to the study and 36 participants did not meet study criteria.
740958|NCT01122680|In this incomplete crossover design, 105 patients were randomised to one of four sequences (in general terms, ABC, BDA, CAD or DCB). Whilst there were 4 possible treatments, A, B, C and D, each patient would receive a maximum of 3 different treatments. Hence, approximately 75 patients would receive each of A, B, C and D at any timepoint.|
740959|NCT01122576|This study took place at two investigative sites in the United States, with the first participant undergoing cataract surgery on 5/18/2010 and last participant completed the study on 6/27/2012.|Seventy eight participants (156 eyes) were enrolled in the study. 148 eyes were analyzed in both the full analysis set and the per protocol set.
740960|NCT01122511||
740961|NCT01122446||
740962|NCT01122394|Participants were recruited from a prior American Heart Association-funded study testing the effectiveness of a 6-mo TI vs. AP. Participants were recruited at completion of the AHA study to participate in the current study for an additional 6 months. They continued to receive the intervention to which they were originally assigned in the AHA study.|
740963|NCT01122381|"Primary Care and Neurology Clinic prescreening and recruitment from VA Pittsburgh hospitals during the following periods:
~1/14/11-4/1/11; 1/14/12-3/19/12; 2/4/13-3/12/14. Average prescreening of datawarehouse records for eligibility = 2954 subjects/month.
~Average prescreening electronic chart review for eligibility = 265 subjects/month."|5 consented. Initial 4 week baseline period uses headache diary to confirm headache days prior to randomization. 3/5 enrollees did not begin baseline phase; 1 lost to f/u, 1 dis-enrolled due to study interruption, 1 dis-enrolled shortly after consent when another physician began a study excluded drug. 2 enrollees did complete baseline phase.
740964|NCT01122316||
740965|NCT01122264||
740966|NCT01122238||
740967|NCT01122173||
740969|NCT01122108|Recruitment started in April 2010 and ended in May 2010. Enrollment officially closed on May 24th, 2010. All patient screening and study visits were conducted at L-MARC Research Center's clinic.|Enrolled subjects were required to meet all of the inclusion and none of the exlusion criteria prior to being randomized to a group assignment. Subjects were also required to undergo vital sign obtainment, a brief physical exam, and a medical history review to ensure they were generally healthy.
740970|NCT01122030|The study was conducted at a single study center in the United States.|Participants were randomized to naldemedine or placebo, screened for 13 days (Days 1-13), and admitted to the clinic on Day 14 for pre-admission assessments. Six cohorts were sequentially enrolled from Cohort 1 (0.1 mg) to Cohort 2 (0.3 mg), Cohort 3 (1 mg), and Cohort 4 (3 mg), and subsequent de-escalation in Cohorts 5 (0.03 mg) and 6 (0.01 mg).
740971|NCT01121991|Participants were recruited in 4 study centers in Canada from September 2004 to October 2005.|55 participants were enrolled in the study, 3 participants discontinued prior to study drug administration as they did not meet the eligibility criteria.
740972|NCT01121939||
740973|NCT01121926||
740974|NCT01121913||
740975|NCT01121900||
740976|NCT01121757|Patients were recruited from June 2010 through January 2012 from the Duke Cancer Institute.|The first 3 patients started on 1a and the next 3 patients started in 1b and the next 3 were in 1a and so on. Eleven subjects consented to the study, 1 patient elected other treatment options prior to assignment and 1 other patient converted to Diffuse Large B-Cell Lymphoma, which made them ineligible.
740977|NCT01121666|Subjects were screened and enrolled at 15 centers in six European countries from July 2010 until April 2012.|Of 460 participants in this trial 88 were reported as screening failures prior the group assignment.
740978|NCT01121575|This was a Phase 1, multicenter, open-label, non-randomized study of combined oral crizotinib and oral dacomitinib in participants with advanced non-small cell lung cancer (NSCLC). The study consisted of a dose Escalation Phase and an Expansion Phase. The Expansion Phase consisted of Expansion Cohort 1 and 2 which ran concurrently.|A total of 70 participants were enrolled and received study treatment in the United States (3 centers) and Australia (1 center). 33 participants in Escalation Phase and 37 participants in Expansion Phase (25 participants in Cohort 1 and 12 participants in Cohort 2) received treatment. The last participant completed the study on 11 Feb 2014.
740979|NCT01121562||
740980|NCT01121549|All participants were recruited from Romania.|
740981|NCT01121536||The final visit of the double-blind study (C10953/3071, /3072, or /3073; NCT01072929, 01072630, or 01305408) serves as the enrollment visit for this study.
740982|NCT01121484||
740983|NCT01121406|"Overall 54 patients were treated in Volasertib arm and 55 patients were treated in Cytotoxic arm. The Not completed category in the Subject Disposition table represents  Treatment permanently discontinued and The reasons for non-completion in the table represent Reason for treatment discontinuation."|
740984|NCT01121393|Two-arm, randomised (2:1 ratio), open-label, active-controlled, parallel-group comparison of afatinib versus gemcitabine / cisplatin chemotherapy.|All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria was violated.
740985|NCT01121263|Study Recruitment started in May 2010 and completed in November 2011 across 11 US medical centers that included adult patients with multivessel coronary artery disease and clinical indication for revascularization, who were candidates for both Hybrid Coronary Revascularization (HCR) and Percutaneous Coronary Intervention (PCI) with DES|
740986|NCT01121250||
740987|NCT01121224||
740988|NCT01121211||
740989|NCT01121185|Patients with HCV genotype 1a infection scheduled to undergo liver transplantation were recruited at 8 U.S. transplantation centers between June 2010 and April 2011. Due to slower than anticipated subject accrual, enrollment was stopped after 13 subjects were randomized; 11 underwent liver transplantation and received the study intervention.|Reasons for exclusion after randomization included identification of a protocol-specified exclusion criterion in the recipient or the donor at the time of organ offer or failure to undergo liver transplantation.
740990|NCT01121172||
740991|NCT01121146|Starting in January 1999 for a period of 18 months, patients were enrolled from an orthopaedic clinic.|Six subjects (6 hips) who had consented to participate were excluded from the study at the time of surgery because they did not receive a hip implant consisting of a 28-mm femoral head and a Duraloc 100 cup with a 4-mm lateralized liner due to intra-operative hip stability, leg length or cup fixation issues.
740992|NCT01120990||
740993|NCT01120899||
740994|NCT01120834||
740995|NCT01120808||
740996|NCT01120782||Due to test article shipment error, one clinical site did not receive control test article in a required cylinder and all screened/enrolled subject were unable to be fitted according to the protocol and were discontinued.
740997|NCT01120756||
740998|NCT01120717||Randomization ratio in the study was 2:1 for QVA149 and Placebo groups. Patients were not stratified by COPD disease severity.
740999|NCT01120704||
741000|NCT01120691|A total of 3865 participants were screened of whom 2224 were randomized to 1 of the 3 treatment groups (QVA149, NVA237 or tiotropium) in a 1:1:1 ratio for at least 64 weeks (maximum 76 weeks) of treatment period.|5 (QVA149), 2 (NVA237) and 3 (tiotropium) participants were randomized but did not receive study drug.
741001|NCT01120639||
741002|NCT01120626||45 participants consented/enrolled in study. Of these, 3 failed to meet inclusion criteria at the baseline visit and thus were not randomized to receive study drug.
741003|NCT01120600||
741004|NCT01120405||
741005|NCT01120379|Subjects are derived from the USA interventional cardiology population.|8000 patients (5034 patients in initial enrollment phase and 2998 patients in second enrollment phase) were enrolled in XIENCE V USA trial. Out of these 5034 patients, 14 patients were transferred to the HCRI DAPT cohort, leaving 5020 in the XIENCE V USA LTF cohort.
741006|NCT01120275||
741007|NCT01120236||
741091|NCT01116427|Participants with relapsing-remitting multiple sclerosis were recruited from 21 sites in the US and Canada between November 2010 and November 2013|
741092|NCT01116401||
741008|NCT01120223|Start date: 22-Nov-2010 Completion date: 15-Oct-2012|Prior to Visit 1 (Day 0), a wash-out period (up to 8 weeks, as defined by the exclusion criteria) was to be completed if the subject had been treated with antipsoriatic treatments or other relevant medication; 2 screening visits were planned.
741009|NCT01120210|This study was conducted in 5 countries: Belgium (3 sites), Germany (3 sites), Italy (5 sites), Poland (3 sites), and Romania (3 sites). A total of 62 subjects (16 subjects in the placebo group and 46 subjects in the JNJ-39588146 group) were randomized and treated with the study drug.|Patients had an option to participate in an 18 hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose. A total of 10 patients (7 patients in the JNJ-39588146 group and 3 patients in the placebo group) participated in the sub-study.
741010|NCT01120197||
741011|NCT01120184||
741012|NCT01120093|This study was conducted at a total of 11 centres; 10 in Germany and 1 in Belgium. The first patient was screened in Apr 2010 and the last patient visit was in Aug 2010.|Patients fulfilling inclusion/exclusion criteria at the time of the Screening Visit were entered into a run-in period of 14 ± 3 days to assess patient's disease stability.
741013|NCT01120067||
741014|NCT01120028|3C was conducted in 18 transplant centres in the UK. Recruitment took place between October 2010 and July 2013.|852 participants were randomized for a comparison of Alemtuzumab (426) and Basiliximab (426) based induction therapies. After 6-months, 394 of those participants were re-randomized to either Sirolimus (197) or Tacrolimus (197) based maintenance therapies.
741015|NCT01119963|Participants between the Gestational age of 23w0d-30w6d were approach in the hospital setting following confirmation of rupture of membranes.|We had two patient that consented to the study but were withdrawn prior to randomization because they began to go into labor
741016|NCT01119950|Participants were randomized to 1 of 8 treatment groups during period 1; participants were then switched to a different treatment group during period 2 after a 7 days wash out. Each period lasted up to 29 days.|For this crossover study, a participant is counted in 2 treatment groups
741017|NCT01119937||211 participants entered screening. 163 participants entered treatment.
741018|NCT01119898||One person who failed screening was randomized in error, but did not receive study drug.
741019|NCT01119859||
741020|NCT01119846|A total of 13, 4 and 83 participants with type 2 diabetes mellitus (T2DM) were randomized in Part A, B and C, respectively. The study was conducted from 05 June 2009 to 19 March 2010 at 8 centers in the United States.|The maximum time a participant spent in Part A, B and C of the study was approximately 10, 7 and 7 weeks, respectively including the 28-days period allotted for screening assessments in all parts.
741021|NCT01119794||
741022|NCT01119768|Three hundred and five patients, out of the 311 patients who signed the informed consent, were randomized to receive 8 weeks (n=154) or 2 weeks (n=151) of esomeprazole treatment.|
741023|NCT01119755||
741024|NCT01119716|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options|
741025|NCT01119703||
741026|NCT01119625|This booster study was conducted in Singapore only wheras the primary vaccination phase (NCT00808444) was conducted in Singapore and Malaysia.|
741027|NCT01119508|Recruitment period: May 26, 2010 to August 29, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.|
741028|NCT01119456||In this dose escalation study, a completed participant was either a participant who completed the initial 4-week treatment cycle (and 2-weeks of observation for specified treatment arms) or one who discontinued therapy, during the same time period, for a narnatumab (IMC-RON8)-related toxicity.
741029|NCT01119443||
741030|NCT01119287|Patients were recruited from one study center in Canada.|Of the 180 patients enrolled, 170 were identified as either ragweed allergic or cat allergic, randomized to one of three study treatments, and received at least one dose of study treatment. Ten additional patients identified as ragweed allergic participated in Visits 1 to 3 only, per protocol design.
741031|NCT01119248|Subjects were recruited in radiology department in MRI holding area.|
741032|NCT01119222||Prior to entering the treatment phases of the study, participants were required to successfully pass cold pain screening tests. Twenty participants were randomized and 19 participants received treatment consisting of a crossover sequence of 4 study drugs administered in sequence I, II, III or IV.
741033|NCT01119131|Participants were recruited from two large treatment centers in the Pacific Northwest and from the community during the time period 2011 - 2014.|Excluded (n=33) Not meeting criteria (n=32) (16 have vitamin D levels that were too high, 4 hx of renal stones, 3 with a history of tuberculosis, and 9 other) Lost to follow-up (n=1)
741034|NCT01119118|Subjects were screened and enrolled at the University of Wisconsin Carbone Cancer Center from April 2010 until July 2011.|
741035|NCT01119105||
741036|NCT01119040|Patients were recruited at University Hospitals Case medical Center between November 2007 and July 2010.|
741037|NCT01119001||
741038|NCT01118988||
741039|NCT01118975||
741040|NCT01118962|"This study began enrollment in August 2010. The study completed in October 2012. The participant flow consists of the Safety Set (SS).
~The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM)."|
741041|NCT01118949|Safety Set (SS) includes all enrolled subjects who took at least 1 dose of Lacosamide (LCM).|Participant Flow and Baseline Characteristics refer to the Safety Set (SS).
741042|NCT01118845||Among the 63 subjects enrolled in the study, 59 subjects received study drug and four subjects were excluded before the first study drug administration. The reasons for exclusion were adverse events and major protocol deviation/violation for two subjects each.
741043|NCT01118780||Study had 3 periods: a screening period (3 to 30 days prior to randomization, no study drug administered), a treatment period (10 weeks), and a taper period (2 weeks). Participants who completed the treatment period were considered to have completed the study. Participant Flow and results, unless specified otherwise, are during treatment period.
741044|NCT01118741|Recruitment dates: 06/04/2010 through 08/01/2011 in medical clinics|Given the toxic effects of disulfiram when administered within 14 days of ingesting ethanol, participants were required to agree not to drink alcohol during the study and for 14 days after its completion.
741093|NCT01116232|Cancer center clinic.|
741045|NCT01118728|The study was conducted at 56 centers in 12 countries. A total of 224 participants were screened between 01 June 2010 and 03 June 2011.|Of 224 screened participants, 223 participants were enrolled and treated. One participant withdrew consent before randomization.
741046|NCT01118715||"The initial protocol had 94 participants. Analysis was run, however, numbers were trending but not significant. Additional participants were then enrolled to increase the power of the study, leading to a larger participant number(128) than the study originally intended to have.
~There is no intention to continue enrolling subjects."
741047|NCT01118663||
741048|NCT01118624|Patients were enrolled between 05 Oct 2009 and 10 May 2011. Patients were enrolled in Hungary, France, and the Czech Republic.|
741049|NCT01118455|Subjects selected for participation in this clinical investigation were chosen from the investigator's general subject population or were referred by a physician who knew the subject well. They were selected for inclusion after consideration of the indications and contraindications of the device. Subjects were outpatients or inpatients.|Subjects were randomized to VNS or AED treatment groups at a 1:1 ratio after being stratified according to their number of previous AED treatments. Of 143 randomized 8 subjects were not treated. One subject (VNS arm) was explanted before device stimulation & excluded. Therefore, 134 [actual] subjects were treated (ITT group): 65 (VNS), 69 (AED).
741050|NCT01118377||
741051|NCT01118351||
741052|NCT01118338|There were 188 participants enrolled into each group, for a total of 376 participants enrolled. There were 185 participants in the redesigned group and 183 participants in the control group who were eligible and dispensed lenses.|
741053|NCT01118325|In total, 146 patients were enrolled at 15 sites from 2 countries (Japan and Philippines). The study period was from April 2010 to March 2011. In total, 139 subjects were randomised and received the investigational product. Most subjects completed the study but 2 Japanese patients discontinued due to an AE during the 4 weeks treatment period.|
741054|NCT01118312||
741055|NCT01118299||
741056|NCT01118273||
741057|NCT01118221||
741058|NCT01118143|Participants were recruited from the waiting list at Tromsø University Dental Clinic. The recruitment started in May 2010 after approval from the regional ethical committee. Information letter with consent form was provided.|"Enrolled participants:
~Total excluded n=46
~Not meeting the inclusion criteria (n=11)
~Declined to participate (n=35)"
741059|NCT01118117||A total of 261 subjects were enrolled in the pivotal study cohort. An additional 15 subjects were implanted with a single, 150mm stent as part of a long length stent (LL) sub-study. The LL sub-study included safety data through 30 days post-procedure and was analyzed separately from the pivotal study cohort.
741060|NCT01118091||
741061|NCT01118052|GOG 170Q accrued 22 patients from November 2010 to January 2013.|
741062|NCT01118013|Between May 2010 and March 2012, 6 participants were recruited.|
741063|NCT01117987||
741064|NCT01117948|First patient in: 09 Nov 2009 Last patient out: 30 Apr 2011 Patients were recruited in Clinics and Outpatient Clinics|Patients were excluded if they did not meet all inclusion/exclusion criteria or if the caregiver was not giving consent to participation in the trial
741065|NCT01117870||
741066|NCT01117857||Of the 29 subjects consented, 7 were found to be ineligible at the screening visit.
741067|NCT01117766||
741068|NCT01117727||
741069|NCT01117623|Adult participants with advanced, histologically or cytologically confirmed solid tumors (including non-small-cell lung cancer (NSCLC) participants enrolled in the expansion portion of the study), malignant lymphomas, or multiple myeloma were enrolled in 5 centers in the USA from 01 FEB 2007 to 22 Apr 2011.|109 (73 male and 36 female) participants were screened according to the inclusion and exclusion criteria to determine their appropriateness for inclusion in the study, and 86 (54 male and 32 female) participants were included at 5 centers, valid for safety population, 81 participants valid for ITT efficacy analysis and PK population.
741070|NCT01117480||
741071|NCT01117454||
741072|NCT01117428||
741073|NCT01117350|"The first patient was enrolled on July 23, 2010. The 24-week comparative period was completed on October 5, 2012.
~The extension period was initiated on March 24, 2011 and completed on March 6, 2013."|A total of 1456 patients were screened in 136 centers, in 17 countries (Austria, Brazil, Canada, Czech Republic, Finland, France, Greece, Ireland, Israel, Mexico, Netherlands, Russian Federation Slovakia, Spain, Sweden, Turkey, USA). Among them, 478 (32.8%) patients were not randomized (main reason was Glycosylated Haemoglobin A1c out of range).
741074|NCT01117337|Between September to December 2008, 120 patients with inguinal hernia presented to randomization at Moulana Hospital, Perianthalmanna, Kerala, India.|15 patients didn't meet inclusion criteria and one patient didn't give consent. 104 patients were randomized to mesh fixation (52 patients) and mesh non-fixation (52 patients). One month and one year follow-up was completed in 100 patients. The follow-up ranged from 15-19 months with a median of 16.2 months.
741075|NCT01117311|Subjects will be recruited out of the study population for a previous multi-center observational study examining the long-term effects of vagal stimulation. In this previous study the Vagal Nerve Blocker (VNB) was implanted.|9 subjects were screened and enrolled, but 2 subjects did not return after the screening visit.
741076|NCT01117181|Clinical center recruited from established outpatient clinics, from living facilities, by local physicians, and from targeted advertisements in local media. The recruitment period started June 2010 and ended October 2011.|
741077|NCT01117090||
741078|NCT01117051||
741079|NCT01117012|Participants with Cystic Fibrosis (CF) who had completed the Study VX08-770-102 (Study 102/NCT00909532) and Study VX08-770-103 (Study 103/NCT00909727), were enrolled in this Study VX08-770-105 (Study 105/NCT01117012).|A total of 192 subjects were enrolled. Efficacy results are presented as per the treatment received in previous study (Placebo/Ivacaftor [VX-770]).
741080|NCT01116986||
741081|NCT01116934||
741082|NCT01116921||
741083|NCT01116895||
741084|NCT01116882||
741085|NCT01116687|Patients with metastatic colorectal cancer who had received at least two prior lines of systemic chemotherapy were enrolled on the study.|
741086|NCT01116661||
741087|NCT01116648||
741088|NCT01116544||
741096|NCT01116024||"Patients who required an aortic valve replacement were considered for this study if they met study preoperative selection criteria.
~Of 173 subjects enrolled, a cohort of 148 subjects was implanted and left the operating room with the study valve. Only subjects who left the operating room with the device implanted were included in the analysis."
741097|NCT01115998|Children were recruited from throughout Oklahoma between February 2002 and December 2003. They were recruited through the statewide early intervention program, parent groups, radio, and contacts with occupational and physical therapists.|We used a matched pairs design and did not find matches for some of the children before they became too old for the study.
741098|NCT01115933|A total of 65 subjects at 15 Japanese sites were enrolled between April, 2010 and August, 2011.|
741099|NCT01115855||
741100|NCT01115803||A 2 phase study, a dose escalation phase and a dose confirmation phase. The dose confirmation phase was not initiated. Participant flow reports those participants who discontinued from study drug. Participants who completed 1 cycle of treatment, had the required assessment or an adverse event (AE) were considered to have completed the study.
741101|NCT01115738||
741102|NCT01115699||
741103|NCT01115673||
741104|NCT01115660|Enrolled patients in 2010 at Wake Forest Baptist Medical Center|Patients assigned to intervention arm and control arm, consecutively.
741105|NCT01115582|In this single-arm study, patients served as their own controls: Reference was presented by the baseline value, when patients received cholic acid capsules prepared by the Cincinnati Children's Hospital Medical Center; Investigational Treatment was the to-be-marketed (TBM) cholic acid capsule administered to patients for 30 days treatment duration.|The study was performed in patients with inborn defects of bile acid synthesis currently receiving cholic acid capsules prepared by the Cincinnati Children's Hospital Medical Center (CCHMC) under IND 45,470. The study planned to include 25 patients; but only 16 patients fulfilled eligibility criteria and were willing to travel to the CCHMC.
741106|NCT01115569||Out of 638 subjects treated with Hydrocodone Bitartate Extended Release (HC-ER) capsules in the Conversion/Titration Phase, 214 subjects discontinued early and 424 continued in the Maintenance HC-ER Treatment Phase; 285 subjects completed.
741107|NCT01115556||
741108|NCT01115517||51 participants were consented and screened for this study, however only 39 of the 51 met eligibility criteria and were randomized.
741109|NCT01115491||
741110|NCT01115452|Participants were recruited at the clinical site|Participants with at least three non-adjacent sensitive teeth were included in the study. Each participant received three treatments during each of the five days treatment. Treatments were randomly assigned to each of the three individual sensitive tooth.
741111|NCT01115309||
741112|NCT01115244||1 participant was consented for this study but never returned for the initial study visit and did not receive treatment.
741113|NCT01115231||
741114|NCT01115166|January 2010 to September 2010 at thoracic surgery department|Included patients (10). All participated in the study.
741115|NCT01115101|Recruitment between July 2009 and November 2009. Of 1112 patients 257 met the inclusion criteria and 239 agreed to participate|
741116|NCT01114997||
741117|NCT01114971||
741118|NCT01114945|"Obese patients (ASA II-III) undergoing bariatric surgery (e.g., laparoscopic gastric band placement, laparoscopic Roux-EN-Y gastric bypass laparoscopic) requiring orotracheal intubation were randomly assigned to one of four study groups.
~Enrollment from May 2010 to February 2012."|
741119|NCT01114893||
741120|NCT01114880||
741121|NCT01114828||
741122|NCT01114737||
741123|NCT01114724||
741124|NCT01114672|Adult patients undergoing maintenance hemodialysis were recruited from two hemodialysis facilities from 8/11/2010 to 8/1/2011.|Three patients failed the screening process due to exclusion criteria: One patient had PTH<70 pg/mL and two patients had serum phosphorus >7.0 mg/dL.
741125|NCT01114646||
741126|NCT01114620||
741127|NCT01114581||
741128|NCT01114555||
741129|NCT01114529|Full analysis set (24 month analysis)|
741130|NCT01114516||
741131|NCT01114503|The study was conducted at a single center in United Kingdom from 23 June 2010 to 29 August 2012.|A total of 2 participants were randomized in cohort A1 of the study. The study was early terminated due to the need of better understanding of an efficacious dose with otelixizumab from other clinical studies.
741132|NCT01114438||
741133|NCT01114373|"79 patients came for screening visit. 39 patients were either screen failures or did not want to pursue the study procedures prior to randomization.
~Ultimately 40 patients were randomized. 4 patients dropped out and 36 completed both arms of the study."|39 patients who came for screening visit, did not make it to the randomization phase either because they didn't meet eligibility criteria or they decided not to pursue with the study procedure.
741134|NCT01114360|"80 patients were screened. 43 patients stopped study participation prior to randomization either due to screen failure or because the decided not to pursue the study procedures.
~37 patients were randomized. There was 1 dropout, and 36 patients completed both arms of the study."|After signing the ICF and going through screening procedures, 43 patients stopped study participation prior to randomization either due to screen failure or because the decided not to pursue the study procedures.
741135|NCT01114334||
741136|NCT01114217|Participants who previously enrolled in and completed AMAG-FER-IDA-301 [NCT01114139], received any dose of study drug, and met the inclusion/exclusion criteria were eligible to enroll in this Extension Study AMAG-FER-IDA-303.|
741137|NCT01114204|The study was open to enrollment for adult participants with iron deficiency anemia (IDA), defined as hemoglobin <10.0 grams (g)/deciliter (dL) and transferrin saturation (TSAT) <20%, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.|
741138|NCT01114139|The study was open to enrollment for adult participants with iron deficiency anemia (IDA), defined as hemoglobin <10.0 gram (g)/deciliter (dL) and transferrin saturation (TSAT) <20%, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.|
741139|NCT01113983||
741140|NCT01113931|Enrollment period began 7 Apr '10|
743988|NCT00958347||226 participants = 262 hips
747692|NCT00769002||
741141|NCT01113892|Recruitment period was from May 2010 to June 2012 at 18 sites in the United States (US) and 7 sites outside the US.|Subjects (209) were randomly assigned to FUSION Bioline (108) or EXXCEL (101) - 2 subjects in the FUSION Bioline group did not undergo surgery and are excluded from all analysis. One (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).
741142|NCT01113879||
741143|NCT01113801||
741144|NCT01113749|425 eligible dementia resident-surrogate dyads identified ; 118 surrogates refused, 41 unable to contact, and 10 unable to participate due to concurrent illness.|No enrolled participants were excluded before assignment
741145|NCT01113723||
741146|NCT01113710|"This study started in May 2010 with subjects from Germany. The study completed in July 2011. The Full Analysis Set is used for study outcome measures.
~The Enrolled Set is reflected in the Participant Flow and Study Demographics. Age demographic information is missing for 1 subject and gender information is missing for 5 subjects."|"The Participant Flow contains single and multiple reasons for Other subject discontinuation. Therefore, individual Other reasons are listed below:
~Augmentation: 7
~Problems with adhesiveness of patch: 6
~Pruritus: 1
~Tiredness: 1
~Less effective than previous medication: 1
~Application site reactions: 2
~Neurotic: 1"
741147|NCT01113632||
741148|NCT01113580||
741149|NCT01113541||Twenty-seven participants were screened for the study and 13 participants were assigned to study drug and treated.
741150|NCT01113463|Recruitment Period: April 27, 2010 to August 09, 2011. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.|The study stopped enrollment of participants since a competing study with the drug combination was planned.
741151|NCT01113398||
741152|NCT01113385||
741153|NCT01113008||
741154|NCT01112982||
741155|NCT01112917||All participants were first implanted with the VenaTech Convertible Filter. After the implantation, the study investigators assessed whether participants were eligible for conversion of the filter or required permanent filtration. If a subject was not eligible for conversion at 6-months, they were considered a permanent filtration subject.
741156|NCT01112865||
741157|NCT01112735||
741158|NCT01112696||
741159|NCT01112683|A total of 42 persons with DS from both genders and between the ages of 18 and 32 were recruited from the community. Thirty nine participants had a cytogenetic diagnostic of trisomy 21 and 3 had complete unbalanced Robertsonian translocations involving a 14 and 21 homologue, leading to an additional chromosome 21.|Two screened subjects were excluded from the trial before assignment to groups: 1 due to an unrelated medical issue and 1 because we could not find age/gender matching subject. And 1 dropped from the trial after randomization due to personal reasons (death in the family).
741160|NCT01112670|Healthy volunteers were recruited from the Denver metro area between November 2009 and December 2010.|Participants (n=145) were genetically pre-screened for ABCB1 1236/2677/3435 diplotypes. Those who possessed the needed ABCB1 genetic diplotypes, along with requisite clinical inclusion criteria, were started in the study (n=33).
741161|NCT01112579||
741162|NCT01112514|Four participants were enrolled in the study, and of these four, one withdrew from the study. All participants were recruited between April 2010 and May 2012.|
741163|NCT01112358||
741164|NCT01112293||
741165|NCT01112267||
741166|NCT01112241|Between April 2010 and May 2010, seventeen consecutive bronchiolitis obliterans (BOS) patients following hematopoietic stem cell transplantation (HSCT) were studied.|In all patients, airflow obstruction was found at spirometry between 14 and 72 months (median, 41 months) after HSCT. The diagnosis of BOS was confirmed by fulfilment of currently updated criteria [Filipovich AH et al. Biol Blood Marrow Transplant 2005; 11:945-956][Chien JW et al. Biol Blood Marrow Transplant 2010; 16:S106-S114].
741167|NCT01112228||
741168|NCT01112059||
741169|NCT01111851||Aprepitant 250 mg was not evaluated because the assessment of the positron emission tomography (PET) scan data (neurokinin 1 (NK1)-receptor occupancy values at 24 & 48 hours postdose) from fosaprepitant 150 mg & aprepitant 165 mg revealed that the protocol's hypothesis was met; therefore, it was not necessary to evaluate aprepitant 250 mg.
741170|NCT01111838||
741171|NCT01111825||
741172|NCT01111604||Completers were defined as participants who had failure event (progressive disease, death), or were off treatment and censored due to study completion.
741173|NCT01111526|Participants were enrolled at Moffitt Cancer Center, September 2010 through December 2014.|
741174|NCT01111474|The patients with dentin hypersensitivity were recruited through posters and folders provided at the Dental Clinics, schools, gyms and drugstores.|The patients which had not achieved an initial level of hypersensitivity were excluded from the trial before assignment to the groups.
741175|NCT01111461||A total of 167 participants were screened for entry into the study. Of these 167 participants, 133 participants met inclusion/exclusion criteria and were treated with at least 1 dose of lenvatinib 24 mg.
741176|NCT01111370|Clinical Research Centers during 12-Mar-2010 to 09-Apr-2010.|Prospective study- the investigator does not assign specific interventions to the subjects of the study in terms of their diabetes management.
741177|NCT01111331||
741178|NCT01111318||
741179|NCT01111305||31 subjects were enrolled on the screening phase of this protocol, of which 13 had Loa loa infection. Of these 13, 3 were excluded for Loa loa microfilarial loads that were too high, 1 could not comply with the trial time points, and one was lost to followup. This left 8 subjects who were enrolled on the treatment portion of the study.
741180|NCT01111292|A total of 73 patients were screened for study eligibility. Of those, 68 patients were ineligible (no biopsies were taken from 5 patients and 63 did not have a diagnosis of dysplasia at the initial visit).|Serum myo-inositol levels were measured from 13 patients who were screened for study eligibility, and those levels (23.28+/-6.46 μM) were consistent with previously published data (Chiu et al, Dolhofer et al, Lewin et al).
741181|NCT01111240||
741328|NCT01103505|1970 Participants 53-90 Years of age at high risk of CNV developing were screened of these 1520 with mean age of 72.5 were enrolled at 44 clinical centers|
741329|NCT01103492||
741182|NCT01111162|The study was conducted at the MacGregor Clinic of the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania, USA, between the months of November and January 2009-2010. All patients signed an informed consent. The study was approved by the University of Pennsylvania institutional review board .|
741183|NCT01111149|Patients were recruited from 12/15/2009 through 4/03/2012. Fliers advertising the study were placed in medical clinics. Additionally, advertisements were placed in local newspapers City Pages and The Minneapolis Star Tribune.|Enrolled participants were excluded from the trial before assignment to groups if they no longer showed interest in the study or failed drug screens.
741184|NCT01111123|This trial was conducted at the outpatient clinic of the MSSM Department of Dermatology Clinical Trials Center, in New York, New York, from January 2009 to March 2010. Recruitment was through: advertisements, referrals from the Dermatology Faculty Practice Associates, and through voluntary faculty and dermatology residents.|Patients who were pregnant/nursing, those on biological or other systemic treatments or other systemic treatments in previous three months, those on topical therapies other than emollients in the past one month, those with pre-existing overt atrophy/telangiectasia in treatment areas were excluded.
741185|NCT01111110|Recruitment process was done in the Asthma Research Lab. Note that 88 were screened and 4 subjects randomized but determined to be ineligile before starting treatment. They are amongst the screen failures.|Subjects qualified in the screening visit went into a 7 day run-in-period They needed to have a 20% peak flow overnight drop on 3/7 nights in order to qualify for overnight stays in the Clinical Research Center. Arms are identified by order of treatment assignment. Any other designation is not consistent with our protocol requirements.
741186|NCT01111058||
741187|NCT01111019|The study was conducted between March 21, 2006 and January 17, 2017.|
741188|NCT01110967||
741189|NCT01110915|Enrollment occurred from June 22, 2010 to October 12, 2011. A total of 269 subjects were enrolled at 35 centers.|A successful implant is defined as having a complete Advisa MRI system implant(Advisa MRI implable pulse generator (IPG) and two Model 5086MRI leads). Six subjects were exited prior to randomization. Of them, 3 subjects did not have an implant attempt and 3 subjects did not have a full Advisa MRI system. All other enrolled subjects were randomized.
741190|NCT01110707||
741191|NCT01110681||
741192|NCT01110499||This was a 2-part study. Patients were enrolled in and completed Part 1 of the study. Then, based on a review of the data from Part 1, a different formulation was selected for Part 2 (Formulation 7). New patients were then enrolled in Part 2 of the study. No patients from Part 1 were enrolled in Part 2 of the study.
741193|NCT01110434||
741194|NCT01110421||
741195|NCT01110408||
741196|NCT01110395|Patients recruited from heart transplant clinic|
741197|NCT01110382||
741198|NCT01110330||All randomized patients (583) received at least one dose of study treatment and were included in the Safety Set. Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Primary and Secondary Outcome Measures.
741199|NCT01110252|From May 2009 to October 2009 four patients with clinical and laboratory diagnosis for advanced pulmonary emphysema were enrolled|Patients signed the Knowledge and Free Consent Instrument (TCLE)
741200|NCT01110239|Subjects admitted to a large community based teaching hospital were recruited between November 2008 and July 2010.|
741201|NCT01110200||
741202|NCT01110187||
741203|NCT01110174||
741204|NCT01110135||
741205|NCT01110005||
741206|NCT01109992|43 subjects consented for the study and 41 subjects completed the study. One subject did not come for the study procedures. One subject could not cooperate with imaging and was moving during the rest scan. Regadenoson scan was not performed.|
741207|NCT01109979|Postmenopausal women ages 45 and 75 were recruited 2009- 2011 via flyers, newspaper advertisements, Craigslist, RSVP for Health, and websites.|Subjects were excluded after screening procedures due to history of hypertension, cardiovascular disease, hyperlipidemia, diabetes, liver disease, cancer, elevated creatinine/potassium levels, abnormal thyroid function, and evidence that menopause was not completed.
741208|NCT01109849||
741209|NCT01109602||Yoga and yoga plus groups were combined for analysis of data for Outcome Measures
741210|NCT01109576||
741211|NCT01109524|First participant, first visit: 1 July 2010; Last participant, last visit: 7 September 2012. Participants were chemotherapy-naive with Stage IV histologically or cytologically documented non-small cell lung cancer (NSCLC). Participants treated until: progressive disease (PD)/ toxicity/patient-investigator decision.|72 participants were enrolled and 60 were treated with study drug. 12 not treated: 10 participants no longer met study criteria and 2 participants withdrew consent before entering the treatment phase.
741212|NCT01109381|Healthy volunteers were recruited, with the first volunteer consenting for screening on 13 May 2010. A total of 205 healthy volunteers were screened for the study, with 164 not being infected with H.pylori and 8 not entering the trial for other inclusion/exclusion reasons.|No group assignment - all participants included were to receive trial treatment. Following consent to take part in the study, participants had a pre-treatment gastroscopy to exclude significant existing upper GI disease. Then all received omeprazole 40mg daily for 1 week prior to receiving the investigational GT08 treatment.
741213|NCT01109316||
741214|NCT01109173|Patients were randomized from 65 sites in 5 countries: US (49), Hungary (6), Italy (4), Sweden (4), and Switzerland (2).|Of the 2120 enrolled participants, 78 withdrew before the start of dosing. Baseline characteristics are presented on all randomized patients with at least 1 postoperative assessment (ITT): 2022.
741215|NCT01109147||
741216|NCT01109108|Children aged 0<60 months with non-toxic appearance presenting for well child or urgent care visit at urban hospital recruited from July 1, 2010 - March 27, 2015; each child could be enrolled only once per 60 day period.|
741217|NCT01109069|27 July 2010 (the first Patient enrolled) to 31 March 2016 (the Last patient enrolled), Study was approved on June 2010.|This study was open to subjects from prior ibrutinib studies who met eligibility criteria for rollover from their parent study and wanted to continue receiving study drug.
741218|NCT01109056||
741219|NCT01109004||
741220|NCT01108835||
741222|NCT01108796|The aim of the study is to investigate the effect of the Lifestyle education tool (Tool/No Tool) for weight reduction on blood pressure control during a six-month treatment with Micardis® / MicardisPlus®. Patients were designated to participate or not participate in a Lifestyle education tool by the investigator under general practice conditions.|A total of 1856 were entered into this trial and 1841 were analysed. For 15 patients case report forms were not available or not usable for analysis
741223|NCT01108757|A total of 52 subjects were recruited.|
741224|NCT01108731||We got informed consent from 37 patients but excluded 3 -- 2 for saving psychiatric diagnoses that were exclusionary and one for having a metal implant which was an exclusion for neuroimaging. Thus 34 patients were randomized for the trial.
741225|NCT01108718|Patients from Principal Investigator's clinical practice at Beth Israel Medical Center in New York who fulfilled the 1990 case definition for fibromyalgia.|Subjects who displayed the existence of a previously undiagnosed sleep disorder were excluded from study participation.
741226|NCT01108666||
741227|NCT01108523|Male or female subjects, age ≥ 18 years old, who were receiving care in a Nursing Home or Long Term Acute Care Facility (LTAC) and who had qualifying moisture damaged skin, with denudation in the range of 2 to 64 cm x cm|
741228|NCT01108510|Participants were enrolled in a total of 144 study sites in Asia, Australia, Europe, and South and North America. The last study visit occurred on 17 April 2015.|867 participants were screened.
741229|NCT01108458||
741230|NCT01108445|131 participants signed consent. 22 were screen failures. 1 withdrew consent prior to being randomized. 108 participant were randomized.|
741231|NCT01108406|Recruitment occurred in April 2010. Subjects were informed about the potential for participation via IRB approved flyers or by indicating interest on consent forms from other studies.|
741232|NCT01108341||
741233|NCT01108263||
741234|NCT01108237|The TruMatch (patient-specific instruments) arm of this study was a prospective, multi-center, non-randomized, clinical investigation conducted at 4 sites. The other arm of this study (conventional instruments) included 84 historical control subjects.|
741235|NCT01108185||
741236|NCT01108094|"Cohort A enrolled at the Stanford University Medical Center (SUMC). Subjects participated in biopsy studies.
~Cohort B was enrolled and participated at the Universidad Catolica de Chile. No biopsy studies were conducted for these participants.
~Untreated Control cohort was enrolled at SUMC. Subjects participated in biopsy studies."|
741237|NCT01108081||
741238|NCT01108068|Participants were recruited from patients with OPPG being treated by Dr Streeten and their unaffected family members|
741239|NCT01108055||
741240|NCT01108003||
741241|NCT01107964||
741242|NCT01107925||
741243|NCT01107912||
741244|NCT01107899||
741245|NCT01107886|The first participant was enrolled on 10 May 2010 and the last participant completed the study on 16 May 2013. A total of 18206 subjects were enrolled in the study of which 16492 were randomised. Study participants were randomized from 790 centers in 26 countries.|Subjects meeting all inclusion criteria and with no exclusion criteria were randomised in a 1:1 ratio to receive either saxagliptin or matching placebo (Day 0).
741246|NCT01107834||
741247|NCT01107795||
741248|NCT01107743|This was a phase 4, observational, open-label study conducted in Participants who were prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.|
741249|NCT01107730||
741250|NCT01107665||
741251|NCT01107535||
741252|NCT01107457|This study has 3 parts:Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose ranging design (approximately 20-40 weeks [wks]).Treatment durability (sustained efficacy off treatment) from Week 20 up to Week 32 was evaluated during Part A.|Part B is an optional extension period with an open-label design (approximately 240 weeks). Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks).
741253|NCT01107444||
741254|NCT01107418||
741255|NCT01107405|This 2 week ocular allergy study was conducted at 2 ophthalmology clinics in the United States. The first participant was enrolled on 4/22/2010 and the last participant visit was 5/30/2010.|238 participants were screened, a total of 101 participants with seasonal and perennial allergy were randomized into the study. These 101 participants comprised the safety population, 90 of which completed the study. The ITT population was comprised of 97 subjects (4 excluded due to no post CAC-assessment).
741256|NCT01107392||
741257|NCT01107379||The lead-in cohort (N=36) consisted of each investigator's first cases where all targeted sinuses were successfully dilated (minimum of 3 cases) with the exception of 4 investigators who participated in the prior ORIOS study.
741258|NCT01107353||
741259|NCT01107197|"Participants: patients (long-term care residents or subjects at home care services) with stage 2, 3 or 4 pressure ulcer.
~Estimated recruitment (sample size): 220 patients. Patients recruited and randomized to interventionas: 200 patients. The recruitment was stopped when at least 64 patients per treatment arm were available for analyses."|
741260|NCT01107015||
741261|NCT01106976|67 patients with Parkinson disease|Patient with Parkinson disease with no contra-indication for MRI.
741262|NCT01106950|Study entry was open to patients 2 years and older regardless of gender, race, or ethnic background.|Seventeen patients were enrolled, however, 2 patients did not receive Ontak (study drug) and were not included in the analysis.
741263|NCT01106911|Subjects were consented, screened and enrolled at one site, a medical hospital specializing in women's health. The period of recruitment was from May, 2010 to September, 2014.|Three subjects were deemed ineligible. Two subjects were withdrawn by the PI after beginning research procedures.
741264|NCT01106898||Of the 112 subjects consented for this study, 3 were ineligible, 9 withdrew before study treatment starting. Only 100 subjects treated were available for analysis.
741265|NCT01106859||Forty-four candidates were screened. Four screening failures: high blood pressure (2), positive drug test (1), personal reasons (1)
741266|NCT01106846|Date of recruitment 03/15/2010-02/14/2013.|
741267|NCT01106833||
741268|NCT01106690|This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin and pioglitazone. The study was conducted between 13 April 2010 and 20 November 2011 and recruited patients from 74 study centers in 11 countries worldwide.|344 patients were randomly allocated to the 3 treatment arms. 342 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set (used for the Week 26 efficacy analysis) and safety analysis set (used for the Week 26 and Week 52 safety analyses).
741269|NCT01106677|This study evaluated the efficacy and safety of canagliflozin compared with sitagliptin and placebo in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin. The study was conducted between 07 April 2010 and 17 August 2012 and recruited patients from 169 study centers in 22 countries worldwide.|1,284 patients were randomly allocated to the 4 treatment arms. All patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set (used for the Week 26 and week 52 efficacy analyses). All 1,284 patients were included in the Week 26 and Week 52 safety analysis sets.
741270|NCT01106651|This study evaluated the efficacy and safety of canagliflozin in older patients with type 2 diabetes mellitus with inadequate control on their current diabetes treatment regimen. The study began on 07 June 2010 and ended on 23 May 2013. Patients were recruited from 90 study centers located in 17 countries worldwide.|716 patients were randomly allocated to the 3 treatment arms. 714 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented for Baseline to Week 104 (Overall Study).
741271|NCT01106625|This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin and sulphonylurea therapy. The study was conducted between 07 April 2010 and 17 April 2012 and recruited patients from 85 study centers in 11 countries worldwide.|A total of 469 patients were randomly allocated to the 3 treatment arms in the study. All 469 patients received at least 1 dose of study drug and were included in the modified intent-to-treat analysis set (used for the week 26 efficacy analyses). All 469 patients were included in the week 26 and week 52 safety analysis sets.
741272|NCT01106586|Participants were enrolled at 146 sites in 16 countries. The first participant was screened on 06 April 2010. The last study visit occurred on 18 September 2014.|1017 subjects were screened.
741273|NCT01106534|Additional 3000 patients were enrolled in the second enrollment phase and had completed phase I at 1 year. In phase II, 870 patients from these were transferred to AV-DAPT cohort and followed from 1 year to 33 months, and the remaining who did not participate in AV-DAPT cohort will be followed for the first year only.|"Outcome measures of participants of XIENCE V USA trial of phase I followed up until 1 year from index procedure are available in the study with ID NCT00676520.
~Outcome measures of participants belonging to XIENCE V USA long-term follow-up cohort of phase II (followed up from year 1 to year 5) are available in the study with ID NCT01120379."
741274|NCT01106456|Participants were recruited from Southern and Northern Plains regions, from reservations communities and in rural locations, including tribal trust land.|Exclusion criteria included intention to leave the state within the next 2 years, being pregnant/breastfeeding, planning to become pregnant in next 4 months, being medically ineligible after screening. Participants were recruited in April 2011, the final participant had their 6-month follow-up in July 2014.
741275|NCT01106430||
741276|NCT01106404|The sponsor activated 10 study centers after the study protocol was approved by FDA in March 2010. The overall recruitment for study subjects lasted less than 5 months, with the first enrollment on April 20, 2010, and last enrollment on September 3, 2010.|Among the 79 subjects enrolled into the study, there were 3 subjects discontinued prior to implantation. The reasons for discontinuations were withdrawal of consent (n = 2) and eligibility criteria not met (n = 1). A total of 76 subjects were implanted and randomized at 4 weeks post implant.
741277|NCT01106391|There were 60 subjects enrolled in this trial at 7 sites in Germany and Italy from March 19, 2010 to June 20, 2011.|Of the 78 subjects consented and assessed for eligibility, 18 subjects did not meet all study entrance criteria and were considered screen failure.
741278|NCT01106352|Study was conducted at seven study centers in United States and one study center in France, between 23 July 2010 (first subject first visit) and 16 June 2015 (last subject last visit).|A total of 70 subjects were enrolled in the study. Of these 17 were in the dose escalation cohort in three dose groups of radium-223 and docetaxel. The remaining 53 subjects were in expanded safety cohort, of them 46 were dosed; 33 received a combination of radium-223 dichloride plus docetaxel and 13 subjects received docetaxel alone.
741279|NCT01106326||
741280|NCT01106287||
741281|NCT01106248|This study was recruited at 5 centers in France from Feb 2009 to Jul 2009.|
741282|NCT01106157||
741283|NCT01106092||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
741284|NCT01106040||
741285|NCT01106027|Patients were recruited from Mayo Clinic in Rochester, Minnesota.|
741286|NCT01106014|A total of 1351 patients were screened from 181 sites in 39 countries worldwide. Of these, 1156 were randomized|Screening assessments were performed up to a maximum of 28 days before baseline
741287|NCT01105975||
741288|NCT01105936|Study was conducted at a single centre in Spain.|Out of 33 screened participants, 31 were randomized, while 2 participants were considered as screen failures
741289|NCT01105767||
741290|NCT01105754||
741291|NCT01105702|From June 2010 to June 2012, 28 patients were enrolled from New York University Langone Medical Center and Outlook Hospital, Summit, NJ.|
741292|NCT01105650||Up to 4 sequential immunosuppressive platforms (study arms) were tested to identify a platform where patients have the potential for successful Natural Killer (NK) cell expansion (defined as an absolute circulating donor derived NK cell count of > 100 cells/μl 14 days after NK cell infusion).
741293|NCT01105533||
741362|NCT01101841|"24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules in subjects with moderate to severe postmenopausal vasomotor symptoms.
~Locations: Medical Clinics"|
741363|NCT01101750||
745092|NCT00901927|Recruitment Period: May 12, 2009 to June 30, 2011. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
741294|NCT01105377|This study opened 4/12/2010, registered 24 participants (Cohort I), and suspended accrual due to toxicity on 9/10/2010. The study registered 23 participants (Cohort II) after re-opening 5/4/2011 with more restrictive eligibility criteria and closed 12/8/2011. The primary endpoint is evaluated using participants registered onto Cohort II.|Interim evaluation of the first 24 participants revealed more extensive disease than expected. Eligibility criteria were modified (as reflected in the Eligibility Criteria section) and registered another 23 patients (Cohort II). One patient in Cohort II cancelled prior to initiating study treatment and is not evaluable for the primary endpoint.
741295|NCT01105312||
741296|NCT01105247|"There are total 133 subjects enrolled however one subject never received treatment. Therefore, number of subjects Started the study is listed as 132 subjects."|
741297|NCT01105130||
741298|NCT01105117|The study was conducted at Pulmonary Hypertension centers in the U.S.|In this extension study patients could continue on the randomized treatment they received in the core study (AC-066A401) until commercial treatment became available.
741299|NCT01105091|The study was conducted at seven Pulmonary Hypertension centers in the U.S. Patients were recruited from these Pulmonary Hypertension medical clinics. Recruitment period was March 2010 through March 2011.|Up to 14 days screening period.
741300|NCT01105065||46 participants enrolled but only 23 had retinal vascular dysregulation.
741301|NCT01104870|The recruitment period for this study was May 2010 to October 2012. Sites were located in the US only.|The 50 subjects who received a dose of study drug are presented here.
741302|NCT01104792||The flexible-dose design for this study was selected to examine the relative safety and tolerability of a range of dosages of cariprazine. The starting dose of 1.5 mg/day was titrated as needed within the range of 3.0 - 9.0 mg/day based on the Investigator's judgment of response and tolerability.
741303|NCT01104779||Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study. No-drug washout period of up to 7 days.
741304|NCT01104766||Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study. No-drug washout period of up to 7 days.
741305|NCT01104701|Study initiated 22-May-2010; completed 27-Dec-2010. Once weekly arm: first dose of exenatide administered at study-site on Day 1; self-administered on a weekly basis over subsequent 20 weeks. Once monthly arm: first dose of exenatide administered at study-site on Day 1;self-administered on monthly basis by participants over next 20 weeks.|
741306|NCT01104662||
741307|NCT01104636||A total of 1391 participants were screened and 1177 participants were assigned to the treatment.
741308|NCT01104584|Recruitment period: 16 May 2010 - 27 Sep 2011|
741309|NCT01104558||A total of 117 participants were screened for the study, out of which 17 were screen failures and 100 participants received the study medication.
741310|NCT01104545|Three panels, each consisting of 8 participants (8 healthy young males in Panel A and Panel B; and 8 with mild-to-moderate hypertension in Panel C) were randomized to receive either MK-3614 or matching placebo in a 3:1 ratio, respectively, in up to 4 treatment periods in Panel A, Panel B and Panel C.|Each period of each panel (with exception of 0.25 mg fasted/fed periods) will be re-randomized to receive either study drug or placebo, i.e., a participant could be assigned to receive study drug in one period and placebo in another. The same participants will receive 0.25 mg MK-3614 in a fasted and fed state.
741311|NCT01104493|Three investigators at 3 clinical research units in the United States of America (USA) enrolled 300 subjects in May, 2010.|
741312|NCT01104415|A total of 15 participants were enrolled in the Core Phase (8-week Dose-escalation Period and the 4-week Stable-dose Period) from 11 sites in the United Kingdom and Germany, and 11 participants entered the Open-label Extension Period.|
741313|NCT01104402||
741314|NCT01104376||The study is started with Consent and screening (Laboratory and medical).Therefore 89 subjects gave consents and where screened. Of those 61 fully completed all phase of the study while 15 partially completed. The 13 subjects gave their consent and were screened, but they did not take any intervention because of abnormal labs.
741315|NCT01104311|The recruitment period of this study was from 07/Apr/2010 to 2/Apr/2014 and there had been recruited at medical clinic.|There were not any significant events and approaches for the overall study following participant enrollment.
741316|NCT01104285||
741317|NCT01104246||
741318|NCT01104207||
741319|NCT01104155||164 participants were screened. Of these 164 participants, 41 were screening failures, and 123 were randomized into the study. Of the 41 screen failures, 31 participants failed to meet inclusion or exclusion criteria and 10 were excluded due to adverse events, withdrew consent, and other reasons.
741320|NCT01104116|The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.|
741321|NCT01104103|We randomly assigned the 26 healthcare providers (16 paramedics, 10 nurses) to use either the BOA® Constricting Band or elastic tourniquets for all IV attempts during the study. Thirteen subjects were in each group. Those that were randomized to the BOA group received training in the use of the device according to the manufacturer's instructions.|
741322|NCT01104025||
741323|NCT01103973||A total of 46 women withdrew or were ineligible for the study. The reasons for withdrawal were: 1) no longer eligible owing to no subsequent IVF cycle (15 patients); 2) too great a time commitment (15 patients); 3) noncompliance with study requirements (7 patients); 4) dislike of study tasks (6 patients); and 5) other (3 patients).
741324|NCT01103960||Whilst there were 324 patients randomised and treated, there were only 314 in the Full analysis set (FAS).
741325|NCT01103934||
741326|NCT01103778||
741327|NCT01103713|Participants were enrolled at 5 active sites in 5 countries: Benin (site 1012), Kenya (site 1004), Malawi (site 1015), Tanzania (site 1008), and Uganda (site 1013). The enrollment of the first participant took place on 07 March 2011 and the last participant last visit was on 25 October 2013.|A total of 404 participants were screened and 168 participants were assigned to study drug, enrolled and treated. Of the 168 participants, two participants were excluded from the pharmacokinetic (PK) analysis, modified intent-to-treat (MITT), intent-to-treat (ITT) and per protocol (PP) populations due to informed consent protocol deviations.
741330|NCT01103479|Recruitment for this study took place between September 15, 2010 and January 30, 2013 across seven federally qualified health centers as well as one large academic health center.|Enrolled participants were excluded from the trial before assignment to groups if they did not reach randomization (e.g. they did not reach the point in the pre-test survey where randomization took place. Therefore they were not assigned to groups. In this study, 3 of the 569 enrolled participants did not reach randomization.
741331|NCT01103466|Subjects were recruited from a user database in Denmark.|41 subjects were enrolled, however 6 subjects did not comply with the inclusion and exclusion criteria. Four of these were terminated before testing any products. Whereas two subjects were included in the safety population as the inclusion criteria violation was first discovered after they tested a product.
741332|NCT01103440|330 patients were screened with 36 enrolled between April 2007 and December 2008|
741333|NCT01103414|The study was conducted at 26 investigational sites in the United States. Over the course of the study, 786 patients were screened, 356 patients were randomized, 297 patients completed the study, and 258 patients completed the study for the Modified Per Protocol Population which required compliance with taking the active medications.|The study consisted of a 14-day, placebo lead-in period & an 84-day double-blind treatment period. At screening, patients were required to have FPG ≥126 mg/dL, HbA1c 7-10%, and insulin C-peptide >1 ng/mL. At the end of the lead-in period, eligible patients were randomized based on a stratification criterion of current metformin use (yes, no).
741334|NCT01103362||
741335|NCT01103323||
741336|NCT01103284|Patients newly diagnosed with Type 1 diabetes were recruited at medical centers in the US, EU, Argentina, and Israel.|
741337|NCT01103271||A total of 33 participants were screened for this study.
741338|NCT01103245||31 of the consented participants did not meet inclusion criteria and did not participate in the study
741339|NCT01103232|All cases were recruited within 6 weeks in the VGEAH PMR Clinic|
741340|NCT01103180||
741341|NCT01103141||
741342|NCT01103063|This Phase 3, open label, randomized, parallel group study screened a total of 3259 participants in 6 sites. A total of 2891 were treated either with azithromycin+chloroquine or sulfadoxine+pyrimethamine.|Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age were to be enrolled in this study. Approximately half of the participants were to be primigravidae and secundigravidae pregnant women since they had a higher risk for suboptimal pregnancy outcomes due to malaria.
741343|NCT01102972|Participants (PAR) were recruited from 44 centers in the United States, including Puerto Rico. ATV, atazanavir; RTV, ritonavir; TDF, tenofovir; FTC, emtricitrabine; QD, once daily; HIV-RNA, human immunodeficiency virus-ribonucleic acid; c, copies; ml, milliliters; ART, antiretroviral; mg, milligrams, ABC/3TC, abacavir sulfate/lamivudine.|HLA-B*5701-negative PAR receiving an ATV/RTV + TDF/FTC regimen QD who are virologically suppressed (plasma HIV-1 RNA <75 c/mL) and met all eligibility requirements were randomized 2:1 to receive an ART regimen of ATV 400 mg QD + ABC/3TC 600 mg/300 mg QD (simplification arm) or ATV/RTV 300 mg/100 mg QD + TDF/FTC 300 mg/200 mg QD (continuation arm).
741344|NCT01102894|Subjects were recruited from the University of Minnesota via fliers on the St. Paul campus|Exclusion criteria included contraindicated conditions for the SmartPill: dysphasia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, previous gastrointestinal surgery, implanted electro-mechanical medical devices, and medications shown to influence gastrointestinal transit time.
741345|NCT01102803|Participants (N = 29; Mean age = 33.38) with acrophobia were recruited from Southern Methodist University and the greater Dallas area from 2009 to 2011.|76 individuals were assessed for eligibility, of which 47 were excluded due to not having a diagnosis of acrophobia (n=37) or declining participation (n=10). 29 individuals were randomized and no participants were excluded after enrollment but prior to group assignment.
741346|NCT01102777|Recruitment was conducted entirely through mail, phone, or internet. Recruitment start was December 2011.|Randomization required Medical Clearance, the completed Baseline Survey, and valid baseline pedometer data. While 307 participants were Consented, only 239 were randomized. The top three reasons for not being randomized were: Pt withdrew prior (23) Failed to submit Medical Clearance and pedometer data (19) or failed to submit Baseline survey (9).
741347|NCT01102764|The research team mailed invitation to participate brochures to a VAMC roster of Veterans of all theatres. IRB-approved recruitment flyers were placed throughout the main hospital and surrounding VA clinics. Furthermore, the team accepted direct referrals from VA providers and the Post Traumatic Stress Disorder Clinical Team (PCT).|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who were analyzed because they completed at least 1 treatment session.
741348|NCT01102738||
741349|NCT01102491|153 patients whose diagnosis was primary osteoarthritis scheduled for unilateral total knee arthroplasty(TKA)at Seoul National University Bundang Hospital from October 2009 to March 2010 were recruited.|11 patients were excluded before assignment. 6 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 2 were refused to participate this study, and 3 were serious medical conditions such as respiratory failure, heart failure.
741350|NCT01102426|"A total of 255 patients were enrolled. 171 Group A (Plitidepsin in combination with DXM) and 84 Group B (DXM alone).
~Enrolled patients between 29Jun10 and 19May15 (Last randomization). The first dose of the first patient was given on 19May15 and the last dose of the last patient was given on 07Aug17."|
741351|NCT01102413||
741352|NCT01102374||
741353|NCT01102270|subjects recruited 2008-2010 from clinics and ads|
741354|NCT01102257||
741355|NCT01102218|This study was conducted at Fresenius Medical Care North America Dialysis clinics between August 2010 and October 2011.|There was no wash out or run in period for this trial.68 subjects signed informed consent, and 48 subjects were randomized.13 of the 20 screen failures were due to exclusionary lab values, 3 due to excluded medications, and 3 were due to other exclusion criteria, 1 due to unrelated SAE. Zero patients withdrew consent prior to randomization.
741356|NCT01102140||
741357|NCT01101997||
741358|NCT01101971|First-year medical students, excluding any with previous clinical training in performing pelvic examinations, were recruited to participate in this study.|
741359|NCT01101958||
741360|NCT01101880||
741361|NCT01101867||
741364|NCT01101542||As per study protocol, subjects who had received 1 or 2 doses of Cervarix vaccine prior to the start of the Post-Marketing Surveillance Study (PMS) could also be enrolled. A total of 3091 participants were enrolled in the study, 105 were available for Year 3 Surveillance and 569 were available for Year 4 Surveillance.
741365|NCT01101477|Patients undergoing elective flexible bronchoscopy (FB) and sedation were screened for enrolment at the bronchoscopic room on the day of exam.|If patients or accompanying family refused to paticipate anytime before assignment to groups.
741366|NCT01101464||All subjects rec'd asenapine 5mg BID on Day 1 & 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
741367|NCT01101334|A total of 90 participants who met all inclusion and no exclusion criteria were randomized to treatment; 89 participants received treatment.|
741368|NCT01101321|23-Jun-2008 (first Informed Consent Form signed) to 19-Aug-2008 (last subject last visit), at 1 site in the US (Honolulu, HI).|114 screened; 52 screen failures; 4 withdrew prior to randomization; 58 randomized; 8 terminated early; 50 completed.
741369|NCT01101308|Study start date: 09-JUL-2008 to end date: 20-Aug-2008, at 1 site in the US (Madison, WI)|124 screened; 69 screen failures; 0 withdrew; 55 randomized and received study drug; 4 terminated early; 51 completed.
741370|NCT01101191|13-Aug-2007 (first Informed Consent Form signed) to 23-Oct-2007 (last subject last visit), conducted at 1 site in the US, (Honolulu, HI)|136 screened; 47 screen failures; 5 withdrew prior to randomization; 84 randomized; 4 terminated early; 80 completed.
741371|NCT01101178|23-Aug-2007 to 26-Nov-2007 at 1 site in the US (Madison, WI).|169 screened; 86 screen failures; 2 discontinued prior to randomization; 81 randomized; 79 randomized and received study drug; 11 terminated early (2 discontinued prior to receiving study drug); 70 completed.
741372|NCT01101165|05-Feb-2007 (first Informed Consent Form signed) to 06-Apr-2007 (last subject follow-up) at 1 site in the US (Evansville, IN).|225 subjects screened; 119 screen failures; 92 randomized and dosed; 12 discontinued and received study drug; 13 discontinued but did not receive study drug; 80 completed.
741373|NCT01101100||
741374|NCT01101061|This study was conducted at 2 study centers in the United States. Eligible participants were healthy, postmenopausal first, second, or third generation Japanese women and non-Japanese women residing in the United States.|Participants were assigned to one of 4 cohorts. In 3 of the cohorts Japanese women were randomized in a 3:1 ratio to receive 1, 3, or 5 mg/kg romosozumab or placebo. In a 4th cohort non-Japanese women were randomized in a 2:1 ratio to receive 3 mg/kg romosozumab or placebo.
741375|NCT01101035|Participants took part in the study at 320 investigative sites in Canada, Mexico and United States from 23 April 2010 to 18 July 2017.|Participants with a diagnosis of gout and significant cardiovascular comorbidities were enrolled in a 1:1 ratio to receive either febuxostat or allopurinol.
741376|NCT01101022||161 subjects were enrolled and randomized, but 2 never received any investigational product, and therefore were not included in subject disposition going forward (n = 159).
741377|NCT01100944||
741378|NCT01100931||One patient withdrew consent before starting treatment.
741379|NCT01100853||
741380|NCT01100762|Study subjects were recruited via phone call or in person from the University of Maryland, Baltimore's Department of Neurology and the Department of Physical Therapy & Rehabilitation Sciences databases. The recruitment period was from January 2010 through June 2011.|
741381|NCT01100723|181 pts in dialysis center. 65 did not meet enrollment criteria. 23 declined participation and 1 had prior intolerance to cinacalcet. Therefore 92 subjects enrolled in study.|No washout. Once enrolled, mineral and bone disorder managed by computer algorithm.
741382|NCT01100658||Only 1 patient was enrolled in this study. This patient completed baseline assessment, but withdrew from the study before beginning the medication trial. No medications/placebo were administered.
741383|NCT01100606||All enrolled participants were administered Zenpep® 5,000 (pancrelipase) from open capsule mixed with a small amount of apple sauce in the screening period for 10 days.
741384|NCT01100567||
741385|NCT01100528||
741386|NCT01100502|Apr 2010-Aug 2014|
741387|NCT01100437||
741388|NCT01100320|22-Jan-2007 (date first ICF signed) to 30-Mar-2007 (last subject follow-up) at 1 site in the US (Austin, TX)|174 subjects screened; 84 screen failures; 2 discontinued prior to dosing; 88 randomized and dosed; 14 terminated early; 74 completed.
741389|NCT01100307||
741390|NCT01100268|Dates of recruitment period are: April 2010-July 2010 Location: Outpatient clinic|
741391|NCT01100255||
741392|NCT01100242||
741393|NCT01100112|Recruited from February 2010 to July 2010|Patient had to have failed to achieve clinical remission in parent study CB-01-02/01. One of the 61 enrolled patients did not receive study drug. Therefore, 60 patients were evaluable for safety and efficacy analyses.
741394|NCT01100086|02-Jan-2007 to 06-Mar-2007 at 1 site in the US (Madison, WI)|167 subjects screened; 83 screen failures; 84 randomized; 1 terminated early; 83 completed
741395|NCT01100073||"enrolled in study: 1703
~treated (received Mirapexin): 1699 (i.e. 4 patients no record of receiving treatment)
~completed study: 1599 (i.e. 100 discontinued prematurely)"
741396|NCT01100034||
741397|NCT01099969||
741398|NCT01099917||
741399|NCT01099774||
741400|NCT01099761||
741401|NCT01099709|03-Jan-2007(first study procedure) to 16-Mar-2007(last subject follow-up) at 1 site in the US(Honolulu, HI)|145 subjects screened; 48 screen failures; 12 alternates/early discontinuations; 85 randomized; 3 terminated early; 82 completed.
741402|NCT01099631||
741403|NCT01099618|new onset type 2 diabetes with BG > 400 or with DKA|
741404|NCT01099579||A total of 82 pediatric patients were enrolled, and 56 received treatment. Reasons for not receiving treatment treated were: no longer met study criteria (23 patients), other reason (2 patients), and withdrew consent (1 patient).
741405|NCT01099475|Inclusion of participants: Oct 2007 - Jul 2009 Location: Department of Surgery, Maastricht University Medical Centre|
741406|NCT01099449||
741407|NCT01099397||
741408|NCT01099358|Due to protocol amendment in September 2011,any newly enrolled participants were placed into cetuximab and cisplatin(C) arm only.After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab(cet) and cisplatin(D) arm only. Group(Grp)A (cisplatin [cis]) completed 3 infusions(inf) of cet (Weeks(wk) 2,3, & 4|[wk 4 = wk 1 of cycle(cyc) 2]) & 2 inf of cis(wk 1 & 4) first 4 wks.Grp B (cet) completed 4 inf of cet (wk 1-4) & 1 inf of cis(wk 4) first 4 wks. Grp C(cis and cet) completed 4 inf of cet(wk 2,3,4, & 5) & 2 inf of cis(wk 1 & 5) first 5 wk. Grp D(cis) completed 1 inf of cet(cyc 1) & 1 inf of cis(wk 1 of cyc 1) and without deviation.
741409|NCT01099267|This extension study was conducted specifically to provide further long-term outcomes as regards overall survival/vital status and the possible occurrence of progression to AML for all participants previously enrolled in study NCT00065156 (Celgene CC-5013-MDS-003). Participants from the original study are included in the Participant Flow.|When the final MDS-003 clinical study report was written, 76 participants had died; therefore, 72 of all 148 participants who first enrolled in the MDS-003 study could have been included in the extension study. Sixteen did not participate because their investigative sites did not participant. Two withdrew consent during the earlier study.
741410|NCT01099215|"The study period was from 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit).
~A total of 30 subjects were screened for study eligibility, of whom a total of 21 subjects were registered (i.e., enrolled) and treated with PVS-10200.
~The study was conducted at 3 study centers in France"|
741411|NCT01099202|Recruitment Period 3/11/2003 - 5/25/2011; all patients were registered at The University of Texas M.D. Anderson Cancer Center.|
741412|NCT01099111|Recruitment was conducted at KFMC (tertiary care medical center), starting 1/7/2010 and completed 29/9/2012. Demographic and clinical data were collected for all, together with performance of colonoscopy at entry and collection of samples as specified.|"We were able to recruit the desired number for normal, IBS and UC groups. However, in view of strict inclusion and exclusion criteria, only 46 were recruited for CD and only 29 were recruited for CRC.
~Moreover, DNA extraction was not sufficient for some subjects at all groups that indicate replacing them with other patients."
741413|NCT01098851|Patients were recruited from July through November 2009 in the medical clinic who were scheduled for surgery that required procedural sedation.|
741414|NCT01098812|Subjects were enrolled from normal cataract populations at 14 investigative sites.|Subjects with low cylinder were enrolled in a randomized group and received either the control lens or the investigational Toric IOL. Subjects with higher cylinder were enrolled in the high cylinder group and received a higher cylinder investigational Toric IOL.
741415|NCT01098747||
741416|NCT01098578|Patients who presented to the emergency department with posterior epistaxis or who were already admitted to hospital for another diagnosis and had posterior epistaxis were offered enrollment. Recruitment period April 2010- April 2012|
741417|NCT01098539||Eligible participants entered into 2 weeks of Pre-screening and Screening; 4 weeks of Run-in/stabilization; 52-week Treatment Period for evaluation of efficacy and safety and 8 weeks of post treatment Follow-up. A total of 771 participants were screened, 507 were randomized and 495 received at least one dose of study treatment.
741418|NCT01098500||This observational study was conducted and supported by GlaxoSmithKline.
741419|NCT01098487||A total of 167 participants were enrolled and received at least one dose of study medication. The 5 enrolled participants from center 082877 were excluded from the analysis due to the following: serious good clinical practice (GCP) findings related to informed consent, source documents and investigator study oversight.
741420|NCT01098474||One enrolled subject was not administered any vaccine and hence was not considered as having started the study.
741421|NCT01098461||Participants (par.) who met eligibility criteria and completed a 4- to 8-week Run-in Period were then randomized to a 16-week Treatment Period, followed by an 8-week Follow-up Period. A total of 215 participants were randomized, and 212 received >=1 treatment dose.
741422|NCT01098318|There are actually 58 subjects who signed consents. However, one subject withdrew consent immediately after signed it due to change of mind. This subject didn't take any medication, therefore, only 57 subject received study intervention.|
741423|NCT01098305||
741424|NCT01098266|Study Period: April 12th, 2010(First enrolment); January 21st, 2013 (date of last enrolment); April 29th, 2014 (cut-off date). 15 clinical sites in Italy, 10 in UK, 7 in USA, 4 in Belgium, 2 in Canada, 2 in Netherland, 2 in Poland, 1 in Egypt, 1 in Ireland;1 in Sweden|Before randomization, the physician had to decide for each patient if he/she was candidate to either Best Supportive Care (BSC) alone or combined with single-agent chemotherapy.
741425|NCT01098253|Patients were recruited from three primary care practices in Philadelphia, Pennsylvania. The protocol was approved by the University of Pennsylvania Institutional Review Board. From April 2010 to April 2011, patients were identified and enrolled.|This trial consisted of two phases: the run-in phase and the randomized controlled trial phase. The purpose of the 2-week run-in phase was to collect pre-intervention adherence rates for all patients.
741426|NCT01098240||
741427|NCT01098162|This observational study started to enroll subjects in March 2010 in order to end up with 113 centers with enrolled subjects in Germany.|Participant Flow refers to the Enrolled Set (ES). The ES comprises all subjects who have been included in the observational study and for whom baseline examination data are available. Three patients were removed from the Enrolled Set after discussion in the Data Review Meeting.
741428|NCT01098110||
741429|NCT01098097|First participant enrolled: 9 February 2009; last participant completed: 17 October 2011. The study was conducted in 117 centers in 12 countries.|
741430|NCT01098071||
741431|NCT01098032|All patients with CKD scheduled for coronary and/or peripheral angiography/angioplasty from January 2009 to December 2011 were screened for inclusion/exclusion criteria. The trial was conducted in across 4 interventional cardiology centers in Italy, according to the principles of the Declaration of Helsinki and Good Clinical Practice|Two enrolled patients did not finally undergo the scheduled treatment due to the occurrence fever or gastrointestinal bleeding
741432|NCT01098006|The study period (i.e., from study initiation until study completion) was approximately 22 months (i.e., from April-2010 until February-2012). The duration of the study was one day for each subject.|All 99 subjects enrolled in the study were included in the analysis.
741433|NCT01097915||
741434|NCT01097863||This reporting group includes all enrolled and dispensed participants. Note: One subject was enrolled but not dispensed due to failing inclusion/exclusion criteria.
741435|NCT01097785|A total of 12 participants were recruited; 6 were allocated to each arm.|
741436|NCT01097707||
741437|NCT01097694|Subjects were recruited from November 2010 until December 2014 in seven academic medical centers.|Following enrollment, 176 subjects entered a run-in period in which several inclusion criteria had to be met prior to randomization, including ACQ requirements and methacholine sensitivity, as well as safety and compliance requirements. 114 subjects who did not meet these inclusion criteria were not randomized.
741438|NCT01097668|Screening and study procedures were performed at hospital clinics within the United Kingdom and Russian Federation.|Subjects were human lymphocyte antigen (HLA)-DRB1*15 positive with relapsing-remitting multiple sclerosis as defined by the McDonald criteria and as assessed by a neurologist.
741439|NCT01097655||
741440|NCT01097629||A 2-week single-blind placebo Run-in occurred prior to randomization. 1 of the 1020 randomized participants enrolled in 2 separate suvorexant trials and is excluded from all summaries and analyses. 10 other randomized participants were not treated and are in Participant Flow Table below, but are excluded from all other summaries and analyses.
741441|NCT01097616||A 2-week single-blind placebo Run-in occurred prior to randomization. 1 of the 1023 randomized participants enrolled in 2 separate suvorexant trials and is excluded from all summaries and analyses. 1 other randomized participant was not treated and is in Participant Flow Table below, but is excluded from all other summaries and analyses.
741442|NCT01097577||
741443|NCT01097460||
741444|NCT01097421|There were 328 patients entered and treated with a documented baseline observation in this study.|This was an open-label, prospective, non-controlled, non-interventional observational, post marketing surveillance study.
741445|NCT01097343|50 patients with 2C19*2 polymorphism were recruited to participate in a cross-over study comparing 75 vs. 150 mg of clopidogrel. 25 patients were randomized to start with 75 mg, and 25 patients started with 150 mg for 30 day dosing periods.|Cross-over study with two 30-day dosing periods. All patients were receiving chronic clopidogrel prior to enrollment after percutaneous coronary intervention.
741446|NCT01097330||
741447|NCT01097304||
741448|NCT01097057||
741449|NCT01097044|"Study Recruitment period: April2010 - July2010
~Study site location:
~Mt. Sinai, New York Carolinas Medical Center, North Carolina University of Alabama at Birmingham, Alabama University of Utah, Utah University of Texas Medical Branch, Texas University of California, San Francisco, California"|
741450|NCT01097005|Patients will be registered using a central registration system. The investigators will register eligible patients with the registration center via FAX by 7 days after initiation of clarithromycin treatment.|
741451|NCT01096992|Recruitment Period: 4/2010 to 012/2013|
741452|NCT01096875||
741453|NCT01096849||
741454|NCT01096823||
741455|NCT01096810||
741456|NCT01096784|The study was conducted in multiple centres in Italy, the Netherlands, Poland, Sweden, the United Kingdom and the United States between 18 Jun 2010 and 30 March 2016.|A total of 121 participants were enrolled and randomized into the study.
741457|NCT01096771||
741458|NCT01096680||
741459|NCT01096667||Prior to randomization, 194 participants received placebo for at least 3 weeks (completed the run-in period). Treated participants included all randomized participants who received at least one dose of study drug.
741460|NCT01096589|"Participants were randomly allocated to the 4 application frequencies for 19 days.
~The randomisation was stratified according to limb location. Enroled participants were randomly assigned to one of the four treatment groups. Patients were treated in private lymphoedema clinics or in NHS centres (UK). US patients were treated in hospitals."|
741461|NCT01096550|"New patients entering buprenorphine treatment at one of the two participating outpatient drug-free treatment programs were block randomized to either intensive outpatient treatment (IOP) or standard outpatient treatment (OP). The study initially included a third clinic site, which was dropped due to insufficient enrollment at that site."|345 patients were randomized. Of those, the following participants were excluded from the study shortly after random assignment: 21 were from the discontinued site, 2 were dropped because of non-standard clinic treatment track, 1 voluntarily withdrew, 2 were erroneously re-enrolled. We also excluded 19 non-African Americans, per study protocol.
741462|NCT01096446|Infants with a birthweight < 750 grams were recruited from April 2008 through March 2010 at the neonatal intensive care unit at at the Children's Hospital of Illinois at OSF Saint Francis Medical Center Peoria, IL.|Thirty-five infants were deemed eligible for the study of which 13 infants were excluded due to one parent refused, 12 other infants were started on TPN prior to obtaining informed consent.
741463|NCT01096342|From 7/2009 to 12/2011, 29 participants were accrued. The study opened at 50 mg/m^2, accrued 2, and closed for safety review and protocol amendment. The study reopened with a dose escalation phase and accrued 4 at 30 mg/m^2 dose, 7 at 40 mg/m^2 dose, and 6 at 50 mg/m^2 dose. The Phase II dose level was set at 50 mg/m^2 and accrued 10 participants.|Of the 10 participants accrued in the Phase II portion of the study, one was excluded for protocol violation. The 6 participants treated in the Safety Analysis Phase at the 50 mg/m^2 dose level (after the protocol amendment) are included in the Phase II analysis. Therefore, this Phase II analysis is based on 15 evaluable participants.
741464|NCT01096316||
741465|NCT01096290||
741466|NCT01096186|Study dates March 25, 2010 through October 19, 2011 Completion of previous trial a requirement|
741467|NCT01096160||
741468|NCT01096056||
741469|NCT01096017|Participants recruited at one clinic in Tokyo, Japan, between March and April 2010|37 participants enrolled; 13 excluded (9 due to eligibility criteria not fulfilled and 4 for other reasons)
741470|NCT01095978||Of the 2822 participants enrolled, 22 were excluded from analysis for the following reasons: No baseline data (11), did not meet inclusion criteria (7), missing or inconsistent inclusion/final data (2), and no Klacid SR treatment (2). The per-protocol population consists of 2800 participants.
741471|NCT01095887|Subjects were enrolled from May 2010 to September 2012 at the Mayo Clinic in Rochester, Minnesota.|
741549|NCT01091116|Outpatients were recruited from March 2010 to November 2010 in private practice and hospitals.|
741472|NCT01095835||The Intent-to-Treat (ITT) population (n=128) included all participants randomized who received at least one dose of study medication. Three enrolled participants (total enrolled n=131) did not receive any study medication and were therefore excluded from the ITT population.The ITT population is reported in the Participant Flow.
741473|NCT01095796|Participants were enrolled at sites in the United States and Puerto Rico. The first participant was screened on 16 March 2010. The last study visit occurred on 02 September 2014.|917 participants were screened.
741474|NCT01095757||
741475|NCT01095666|Of 1484 patients enrolled, 554 completed a qualification period. Of these 554 patients, 444 were randomized and received treatment. Of these 444 participants, 409 completed the double-blind treatment period|
741476|NCT01095653|Of 1179 participants enrolled, 514 completed a qualification period. Of these 514 participants, 393 were randomized and received treatment. Of these 393 participants, 343 completed double-blind treatment period.|
741477|NCT01095510|Participants were not enrolled in the lower body weight category (10-25 kilograms [kg]) 1000 Units (U) dose group despite substantial recruitment efforts.|Of 12 participants screened, 9 participants were enrolled and treated. The reason for 3 participants were screen failures as they did not meet the inclusion criteria.
741478|NCT01095497||
741479|NCT01095250|Disposition of the 31 randomized patients is summarized in the table below. As a consequence of the early termination, few patients (N=31) were randomized into this study. Of these, 30 patients were discontinued due to administrative reasons (30 patients due to study termination and also one due to misrandomization). One patient withdrew consent.|As a consequence of the early termination, few patients (N=31) were randomized into this study. Of these, 30 patients were discontinued due to administrative reasons (30 patients due to study termination, including one due to misrandomization. One patient withdrew consent.
741480|NCT01095094|Patients were recruited from medical clinic May 2008 to May 2009.|
741481|NCT01095003||
741482|NCT01094886||
741483|NCT01094808|The study was conducted between April 2010 and January 2011 at the Mayo Clinic, Rochester, Minnesota.|
741484|NCT01094782||"254 participants were enrolled in the study and were randomly assigned to one of the 6 study arms at Visit 1. 6 participants were later found to be ineligible to continue to participate (e.g. drug screen, medical history, no longer interested) further in Visit 1 and they did not recieve study intervention."
741485|NCT01094743||
741486|NCT01094730||There were five subjects enrolled who were not randomized to a study arm due to exclusion criteria dropping the study enrollment from 185 to 180.
741487|NCT01094717||
741488|NCT01094704||
741489|NCT01094574||
741490|NCT01094561|Subjects were accrued from June 2007 to April 2011. All subjects were accrued and followed at Columbia University Medical Center.|
741491|NCT01094548|First/last participant (informed consent): 21 January 2008/11 January 2010. Last participant completed: 07 March 2012; Clinical data cut-off date: 07 March 2012.|A total of 36 participants were screened for eligibility; 2 were excluded (mainly non-fulfillment of inclusion or exclusion) and 34 participants were enrolled and randomized.
741492|NCT01094522||Total 47 subjects were enrolled. 7 were withdrawn prior to randomization. 40 were randomized.
741493|NCT01094301|Recruitment began in April 2010 and was concluded in March 2016. Subjects were screened for the study from the available pool of candidates who presented to the Investigators with shoulder pain following stroke.|In the original study design, subjects who completed the trial stage and were a success were enrolled in the fully implantable phase. In the revised study design, subjects were required to be both a trial stage success and have a return of pain to be enrolled into the fully implantable phase.
741494|NCT01094288|Participants took part in the study at 4 investigative sites in the United States from 17 August 2010 to 04 January 2017.|Participants with a diagnosis of Advanced solid tumors, including castration-resistant prostate cancer were enrolled to receive alisertib Alisertib 10-40 mg + docetaxel 60-75 mg/m^2 intravenous (IV) infusion and granulocyte colony stimulating factor (GCSF) in escalating dose cohorts.
741495|NCT01094184||A total of 53 participants were screened; 49 participants were eligible for the study and assigned to study treatment
741496|NCT01094171||
741497|NCT01094119||
741498|NCT01094106||Three patients were excluded after recruitment and randomisation, for the following reasons: For one patient, an emergency operation was needed before the scheduled operation time; for one patient, the hospital pharmacy was unable to provide the study drug in time, and for one patient, no study drug was initiated because of communication errors.
741499|NCT01093976||
741500|NCT01093885|Recruitment took place in the clinic over a 5 year period|None of the patients were able to increase the dosage of ambrisentan from the initial dose of 5 mg to 10 mg.
741501|NCT01093846||
741502|NCT01093794|28 participants were randomized in four treatment sequences. Participants had a 7 day minimum washout period between treatments.|
741503|NCT01093755|Participants were recruited from Mayo Clinic patients in Rochester, Minnesota who had undergone an ablation procedure for Barrett's Esophagus.|
741504|NCT01093690|Recruitment period from April 2009-June 2010.|All recruited patients were participate enrollment.
741505|NCT01093651|HIV-infected adults (18 - 65 years old) were recruited from the AIDS Clinical Trials Unit and the Infectious Diseases Clinic at Washington University School of Medicine. Thirty-one candidates were screened and 20 were enrolled; all participants were HIV positive but were otherwise healthy with stable immunologic and virologic status on HAART.|Twenty participants were randomized to n=10 placebo or n=10 sitagliptin (Januvia(R)). Eleven volunteers were screened and found ineligible (see eligibility criteria), or did not choose to participate in the study.
741506|NCT01093625|There were 157 subjects consented to participate in this study. Fifty-nine (59) subjects were determined to be ineligible. This allotted forty-nine (49) subjects randomly to each study arm for a total of 98 subjects enrolled.|Of the 59 identified as ineligible prior to group assignment, the majority were due to having a preexisting astigmatism.
741507|NCT01093599||
741508|NCT01093586|Participants recruited from medical hospital from 9/2007 thru 2/2013.|
741509|NCT01093573||
741510|NCT01093534||
741550|NCT01091103|Single center clinical trial|
741551|NCT01090973||
741511|NCT01093521|Subjects were recruited in the Adult cystic fibrosis clinics at 3 centers (the University of Washington, University of Iowa, John's Hopkins University) from the second quarter 2010 and closed February 1, 2012. The study had two dosing cohorts. Cohort 1 completed enrollment in February, 2011. Cohort 2 completed enrollment on February 1, 2012.|We employed no run-in period. No subjects withdrew after randomization.
741512|NCT01093482|Consecutive patients who required mechanical ventilation for more than 12 hours in the participating intensive care units.|
741513|NCT01093469||
741514|NCT01093417||
741515|NCT01093222||
741516|NCT01093183||
741517|NCT01093027|Visits were scheduled between June 2010 and December 2011.|
741518|NCT01093014||
741519|NCT01092923|Dates of recruitment: December 2009 to April 2010 Location: Austin Health|Exclusion criteria: patients with history of severe lung disease (defined as FEV1<1.5 L or FEV1/FVC<50%), symptomatic ischemic heart disease, super obesity (BMI>45), pregnancy, prior severe post-operative nausea/vomiting, critically ill/immunocompromised, Vitamin B12/folate deficiency, or presence of any gas-filled, space-occupying lesion.
741520|NCT01092910|"Subjects were recruited at three different sites:
~The Ear Center of Greensboro Greensboro, NC 27401
~Shohet Ear Associates Medical Group, Inc. Newport Beach, CA 92663
~Lahey Clinic Burlington, MA 01805"|
741521|NCT01092832||
741522|NCT01092780||
741523|NCT01092767|A total of 25 investigational sites were activated and allowed to enroll in the RESCUE study in the US and Canada. A total of 50 subjects were enrolled at 20 of the 25 activated investigational sites, with the first enrollment on April 14, 2010 and the final enrollment on January 17, 2012.|All 50 subjects enrolled were implanted with the device (Valiant Thoracic Stent Graft with the Captivia Delivery System ).
741524|NCT01092728|Recruitment Period: March 2011 to September 2013. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.|A total of 19 participants were enrolled, out of which 18 participants were included in the analysis and 1 participant was a screen failure.
741525|NCT01092702|Recruitment began on 04/14/2008 and finished on 08/28/2008. Recruitment was in the general community of Rochester, Minnesota|All potential participants consenting to enrollment completed a series of screening questionnaires. The questionnaires included demographic information, alcohol and smoking history, the the Center for Epidemiological Studies-Depressed Mood Scale, DAST-20, medical history and physical exam.
741526|NCT01092676||
741527|NCT01092663|Study period from February 2010 to December 2010. This was a multi-center, randomized, open-label, prospective, parallel-group study consisting of 12 weeks of active treatment.|Subjects treated with acarbose, sulfonylurea or metformin and an A1C ≥6.5% and ≤9% were eligible to enter the study after a 4 (acarbose and sulfonylurea) or 8 (metformin) week wash-out period when meeting all other criteria.
741528|NCT01092637||
741529|NCT01092559||
741530|NCT01092546||Started with 16 subjects and 4 withdrew prior to dosing leaving 12 subjects for study.
741531|NCT01092507|Participants were enrolled from 07 March 2010 to 27 April 2011 at 3 clinical centers in Thailand.|A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled; 299 were vaccinated.
741532|NCT01092442||
741533|NCT01092416|The study received approval to enroll up to 429 subjects. Following the introduction of the Electric OAS, the enrollment was expanded to a maximum of 479 subjects, to enroll 100 subjects with the Electric OAS. A total of 443 subjects were enrolled in the study between May 25, 2010 and November 26, 2012 at 49 U.S. study sites.|A subject was considered enrolled when a signed informed consent was in place, all inclusion/no exclusion criteria were met, and the study guidewire had crossed the target lesion.
741534|NCT01092364||
741535|NCT01092338|The Study started enrollment in 01/2010 and completed in 01/2011. A total of 44 subjects were enrolled including 19 with perinatally-acquired HIV/AIDS (PA) and 25 with behaviorally-acquired HIV/AIDS (BA).|Subjects taking a vitamin D supplement or multi-vitamin were eligible if they were willing to discontinue supplementation after a minimum of a 2 month washout period.
741536|NCT01092195||
741537|NCT01091974|138 Patients were consented of which 114 were eligible.|18 Withdrew prior to randomization (3 ceased responding to contacts, 4 changed mind , 3 began or restarted sleep medication, 4 did not complete baseline measures, 1 did not receive approval from physician to participate, 1 found the diaries too much trouble, 1 did not want to take study medication, and 1 had a family emergency).
741538|NCT01091948||
741539|NCT01091675|The study enrolled 58 patients in total, with ankylosing spondylitis, and Inadequate response to ≥2 NSAIDs. Patients who met The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of 4 or higher and all study criteria participate in the study and were randomized at 14 study sites. The last patient completed in May 2013.|From a total of 58 patients recruited 1 did not met the exclusion criteria, so 57 patients start the first phase. 4 patients abandoned the study due to hypertension. 53 patients completed the first phase. 27 did not proceed to phase 2 due to lack of efficacy and 3 patients were withdraw due to hypertension. 23 patients complete the study period.
741540|NCT01091662||
741541|NCT01091519||
741542|NCT01091454||
741543|NCT01091428|Participants took part in the study at 33 investigative sites in France, Poland and the United States from 16 April 2010 to 19 July 2017. Data cutoff for the primary analysis was 12 August 2014.|Participants with a diagnosis of ovarian cancer or breast cancer were enrolled equally in a dose escalation study to determine the recommended Phase 2 dose. In Phase 2 participants were randomized equally to receive alisertib 40 mg BID + paclitaxel 60 mg/m^2 or single agent paclitaxel 80 mg/m^2.
741544|NCT01091363|2010-2013.|232 people were screened and 123 were excluded before randomization.
741545|NCT01091259|From April 2010 to May 2013, 29 patients were enrolled from New York University Langone Medical Center.|
741546|NCT01091246|A total of 2,481 participants provided written informed consent and were screened for the study. Of these, 2,312 participants were randomized into the study between 29Mar2010 to 12May2010 at 97 sites in the USA.|Eligible participants were randomized in a 3:1:1 ratio to receive Q/LAIV, FluMist/B/Yamagata, or FluMist/B/Victoria. Randomization was stratified by age (2 to 8 years, 9 to 17 years). For subjects 2 to 8 years of age only, randomization was also stratified by previous seasonal influenza vaccination history.
741547|NCT01091168||
741548|NCT01091155||
741553|NCT01090765||"The study did not make it to the phase II (Arm 1-chemotherapy-naïve for metastatic disease (no prior antiangiogenic therapy) and Arm 2- post-docetaxel disease progression; evidence of disease progression despite prior docetaxel and bevacizumab) portion, thus no data is available for the phase II outcome measure progression free survival."
741554|NCT01090752|Sixteen subjects were examined, 8 with a diagnosis of type 2 diabetes (DM2) and 8 with a diagnosis of systemic hypertension (HTN). The participants were recruited by hospital placards detailing the study, and through ambulatory care centers in Lausanne and Geneva.|Each subject was randomised to receive either pioglitazone or placebo for 6 weeks, with a 2 week wash-out period between the two treatment phases. Randomisation of the sequences of placebo and active treatment periods were performed by a doctor having no contact with participants and clinicians.
741555|NCT01090739|Subject recruitment occurred from July 2010 - December 2012.|Following enrollment (i.e., signing informed consent form), subjects underwent two screening visits to evaluate and confirm eligibility for the TOPAS implant procedures.
741556|NCT01090492||A total of 243 participants were stratified into 2 cohorts (Primary Raynaud's phenomenon[PRP] and secondary RP[SRP]), who entered a 2-week placebo run-in period (to establish baseline), followed by a cross-over period (first 4 week treatment period,then a 2 week placebo washout,then 4 week treatment period) and then a 2-week placebo run-out period.
741557|NCT01090479||
741558|NCT01090453|A total of 480 subjects were enrolled in the study.|
741559|NCT01090427|A total of 110 volunteers from 10 countries were randomized and treated in this study.|A total of 110 participants started and completed the first period in the study (ie, controlled period [CP] and entered the 2nd period (ie, After the Controlled Period [after CP]); however, only 101 of the 110 participants completed the 2nd period (after CP) of the study.
741560|NCT01090414|Participants were enrolled at study sites in the United States. The first participant was screened on 22 March 2010. The last study visit occurred on 18 June 2018.|Participants must have been enrolled in a previous Gilead-sponsored study.
741561|NCT01090323||
741562|NCT01090310|Between August 2010 and March 2011, 70 patients were enrolled from 51 centers in 9 countries (United States, Germany, Switzerland, India, Spain, United Kingdom, Israel, Brazil, Italy). Recruitment was stopped due to study termination, therefore 16 out of 86 patients signed informed consent while being in core study were not enrolled into extension|In total, 125 patients were randomized to the core study with 1 patient misrandomized. Of these 124 patients 70 patients entered the extension period of the study. Core study NCT01032915
741563|NCT01090180|67 participants excluded from initial recruitment sample for the following reasons: baseline assessment inclusion criteria not met (n = 18), declined enrollment post-consent (n = 1), exclusion criteria met (n = 26), lost to follow-up (n = 24).|
741564|NCT01090141||The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available
741565|NCT01090102||
741566|NCT01090076|26 subjects were recruited between June 2010 to June 2011 and all subjects were inpatients of Changi General Hospital. 23 subjects completed the trial.|Subjects were randomly assigned to either arm after an initial assessment by PI and wound nurses. There is no wash out period for this trial
741567|NCT01090063|Recruitment from Apr 2010 to Sept 2011 in the dermatology clinic of a tertiary care hospital.|Washout of 2 weeks for topicals, 4 weeks for all other biologics and systemics prior to baseline dosage.
741568|NCT01090050|Recruitment period was from date of Institutional Review Board (IRB) approval (8-3-10) until date last patient enrolled (1-30-12). Subjects were recruited from general population at two clinical research centers.|Subjects completed a 30 day Baseline period between Visit 1 and Visit 2 before Randomization. Subjects must have had 15 or more headache days during the 30 day Baseline period in order to be randomized into the study Treatment periods. Fifty-six subjects were screened for study, however only 28 subjects randomized for treatment due to screen fail.
741569|NCT01090011||171 patients were entered and treated in the study.
741570|NCT01089751||
741571|NCT01089647|Thirty-four consecutive patients were recruited from the sleep medicine clinic at St. Luke's Health System from 24 June 2010 to 20 March 2013|
741572|NCT01089608||
741573|NCT01089595|During the period of February 2, 2009 through May 26, 2011, recruitment occur at oncology hospital.|
741574|NCT01089582||
741575|NCT01089569||
741576|NCT01089556||The study consisted of 4 study periods (SP): 2 weeks screening and washout (SP I), 8 weeks initial treatment (SP II), 8 weeks intensive treatment (SP III), 2 weeks tapering (SP IV). Participants who did not achieve good pain control during SP II (<30% improvement) were considered non-responders and continued in the study and entered SP III.
741577|NCT01089543|This study was recruited at 66 centers in Japan during the period of 21-April-2010 to 12-Aug-2011.|Participants were initially enrolled into a 1- or 2-week run-in period (single-blinded administration of placebo). Participants who did not respond to placebo were randomized to an 8-week treatment period (double-blinded administration) of rabeprazole 10 mg, 20 mg, 40 mg, or placebo, once daily after breakfast.
741578|NCT01089517|This study enrolled 449 patients at approximately 69 centers in North America, South America, Europe and Israel.|
741579|NCT01089504||
741580|NCT01089413||
741581|NCT01089361|Patients were recruited between 2009 and 2010 from the ICU.|All patients who consented were randomized to treatment or placebo.
741582|NCT01089231|The recruitment of subjects was performed by several advertisements and study placards in hanover from january until february 2010. By a telephonic preselection 106 subjects were selected according to inclusion criteria.|Serum lipid levels of the preselected subjects were determined and 20 normolipidemic and 20 dyslipidemic men were enrolled in the study population.
741583|NCT01089127||
741584|NCT01089062||This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.
741585|NCT01089023||
741586|NCT01088997|Recruitment began in June 2010 at three large academic medical centers. The study was closed to enrollment at all sites in November 2013.|
741587|NCT01088984|Of the 46 patients screened, 43 patients at 24 centers from the United States, Australia, South Korea, Israel, Mexico, and Brazil met entry criteria and were considered eligible for enrollment. Of the 3 patients who were not enrolled, 2 patients died prior to study enrollment, and 1 patient was ineligible because inclusion criteria were not met.|
741588|NCT01088815||98 subjects signed consents in total. 26 subjects were screen-fails
741589|NCT01088711||
741590|NCT01088672||
741591|NCT01088646|3 hospital sites|
741592|NCT01088529|The study was conducted from 20 November 2009 to 14 March 2013. Participants were recruited at 1 study center in the United States.|66 participants were randomly allocated to the 2 treatment arms and were included in the intent-to-treat (ITT) analysis set. 65 participants received at least 1 dose of the study drug and were included in the safety analysis set.
741593|NCT01088503||Centralized follow-up visits were conducted for all participants. Participants who completed 15-month active follow-up were considered to have completed the study.
741594|NCT01088464||The study had 3 cohorts and dose escalation in successive cohorts was to occur once all the participants completed 1 cycle of therapy. A completed participant was either a participant who completed the initial 6-week treatment period (Cycle 1) or a participant who discontinued therapy for an IMC-11F8 (Necitumumab) related toxicity during Cycle 1.
741595|NCT01088438|All fourth-year medical students at the University of Illinois at Chicago (UIC) College of Medicine who were enrolled in internal medicine subinternships at one of 2 sites (UIC or Jesse Brown Veterans Administration Medical Center) July 2008 - April 2009 or August 2009 - April 2010 were eligible.|
741596|NCT01088412||
741597|NCT01088399||Participants were initially enrolled in 2 regional observational studies (B9R-EW-GDDQ [GDDQ] initiated in 1997 and B9R-MC-GDEE [GDEE] in 1998) which were merged into the global Study B9R-MC-GDGA (GDGA, NCT01088399) in 2002. This record spans approximately 15 years from the initial enrollment in regional studies to completion of Study GDGA.
741598|NCT01088295|Subjects were recruited between May and October 2010 at the UCLA CARE Center.|
741599|NCT01088243||
741600|NCT01087996|Participants were enrolled between April 2, 2010 and September 14, 2011|One patient did not receive Autologous MSCs because they became ineligible.
741601|NCT01087970||
741602|NCT01087957||
741603|NCT01087944|A total of 60 participant's data were included from USA (10 centers). The inclusion period was between 11th March 2010 and 28th May 2010.|This was a two-arm, randomized, crossover study in adult participants with hepatitis C infection. Participants were randomly assigned to one of two groups, in which they received injections by either pre-filled syringe (PFS) or autoinjector (AI) for the first 3 weeks and then switched to the other injection method for an additional 3 weeks.
741604|NCT01087931||
741605|NCT01087918|Participant recruitment from a spinal cord injury hospital in Zurich, Switzerland between March 2009 and March 2011.|97 possible participants recruited; 9 participated, 88 excluded (12 did not meet inclusion criteria and 76 refused participation)
741606|NCT01087905|Adult smokers who called the Wisconsin Tobacco Quit Line (WTQL) from April 1, 2010 to June 15, 2010 were invited to participate in the study; no advertising or targeted recruitment was utilized.|
741607|NCT01087814||
741608|NCT01087801||
741609|NCT01087788|This study started to enroll patients in March 2010 and concluded in August 2015.|"The study included a 24-week Double-Blind, a 24-week Dose-Blind, and an Open-Label Treatment Period.
~409 subjects are included in Randomized Set (RS) shown in the Participant Flow, which is an Intention- to- Treat (ITT) dataset."
741610|NCT01087775|Recruitment flyers were posted on poster boards and electronic billboards around the SFVAMC; collaborated with other investigators to refer potential participants; utilized social media and created a website. We targeted community-based VA facilities, other Veteran community based organizations and local colleges and universities.|
741611|NCT01087762|This is a multicenter study with 128 sites in North America, Latin America, Western Europe, and Central/Eastern Europe. 325 subjects are included in Randomized Set (RS) shown in Participant Flow for the interim period, and 315 for the final analysis (10 subjects dropped out before receiving a CZP dose), which is an Intention-to-Treat (ITT) dataset.|Patients with positive Tuberculosis (TB) tests within Screening Period, but no signs and symptoms of active TB had to be treated with prophylactic TB treatment for at least 4 weeks prior to first study drug administration.
741612|NCT01087736||
741613|NCT01087723||
741614|NCT01087541||
741615|NCT01087528||
741616|NCT01087502||241 patients were randomised to treatment with linagliptin 5mg (n=118) or placebo/glimepiride (n=123). All randomised patients were treated. For the final analysis, one study site was excluded due to serious non-compliance resulting in 122 patients in the placebo/glimepiride group and 113 patients in the linagliptin group.
741617|NCT01087489|Miami VA Medical Center retina injection clinic; patients needing frequent intravitreal injections of ranibizumab were approached and recruited between April 2010 and March 2011|Patients were randomized upon recruitment and received the first anesthetic method on the day of recruitment, no wash out or transitional periods were necessary
741618|NCT01086969|Participants were enrolled from 11 June to 01 October 2010 in 3 clinical centers in India.|A total of 300 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
741619|NCT01086852||
741620|NCT01086761||
741621|NCT01086605||
741622|NCT01086540|Twenty-six study sites in the US were activated. Of these, 19 sites screened a total of 108 participants. Fifty-seven participants were randomized and study results summarized.|
741623|NCT01086475|Participants were recruited from academic autism treatment centers, local schools, and community organizations.|One subject with ASD was excluded from analyses due to early dropout prior to taking the study drug.
741624|NCT01086423|Out of the 985 subjects originally enrolled in the study, 984 subjects were vaccinated with at least one dose of the study vaccine.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
741690|NCT01083485|First patient first visit 25 March 2010 and last patient last visit 17 Oct 2010. Five Hospital Investigator Centres|14 day screening period before planned surgery. Run-in period 48 hours, 2.5 day double-blind period after surgery
741625|NCT01086410|Participants who met all the inclusion criteria entered a 7- to 14-day Run-in Period (screening visit [Visit 1]). Participants were provided with albuterol/salbutamol inhalation aerosol for relief of asthma symptoms during the study.|At the end of the Run-in Period, participants who meet the randomization criteria were admitted to the clinic in the evening (Visit 2) for the Baseline collection of 24-hour serial serum cortisol samples and urine. Eligible participants were randomly assigned to one of four treatment groups in a 4:4:4:1 ratio.
741626|NCT01086384||Participants (par.) who met all entry criteria at Screening entered a 2-week Run-in Period for completion of Baseline safety evaluations and to obtain Baseline measures of asthma status. Participants who met continuation criteria at the end of the Run-in Period were randomized to receive study treatment.
741627|NCT01086358|60 Subjects who are employed in a paying job, who have episodic migraine (<15 days/month), who are using an acute care triptan monotherapy for their migraine (excluding combinations of any sort, such as acetaminophen [APAP] and non-steoridals [NSAIDs]) and who have no contraindications to triptan or NSAID use.|This study had no wash-out or run-in phase.
741628|NCT01086228|A total of 2010 patients were registered. Of which 1 patient was excluded from this analysis. Therefore, 2009 patients (1,159 patients treated with XIENCE V; 850 patients treated with PROMUS) were included in the analysis.|Study has excluded those patients who were treated with stents other than CoCr-EES (XIENCE V or PROMUS), or underwent concomitant treatment of a graft vessel. Patients were invited to enroll in the study after apparently successful per-cutaneous coronary intervention (PCI).
741629|NCT01086215|Patients presenting at a participating site who were clinically indicated for a peripheral interventional (arterial, venous or hemodialysis access) procedure with the AngioJet Thrombectomy System were offered the opportuntity to participate. Patients were recruited from January 2010 thru June 2013.|
741630|NCT01086150||
741631|NCT01086033||
741632|NCT01085968||Participants were assigned to group depending on disease status
741633|NCT01085903||
741634|NCT01085825|We enrolled a total of 500 women from April 22, 2010 to October 14, 2011; 252 women were randomized to MVA and 248 to EVA.|
741635|NCT01085812|Patient were recruited over a 10-month period from March of 2010 to January of 2011 at 36 studies sites, 30 in the United States and 6 in Canada.|Patients began with a 12-week open-label treatment period, followed by a 24-week double-blind treatment period.
741636|NCT01085786|recruitment period: Aug 2008 - May 2010|no significant events for the overall study
741637|NCT01085760|A total of 35 adult patients with primary sclerosing cholangitis (PSC) were enrolled between February 2010 and November 2011 at Mayo Clinic, Rochester MN.|
741638|NCT01085734|The study was conducted at a single center. The first subject for this study was screened on 18MAR2010 and enrolled on 26MAR2010. The subjects were existing patients in our medical clinic.|In total there were 10 screen failures; 4 did not meet the visual acuity requirements,3 did not meet the OCT requirements. One subject withdrew consent prior to randomization and one withdrew prior to randomization due to health issues
741639|NCT01085682||
741640|NCT01085643|Recruitment dates: March 2010 to December 2010 Recruitment place: GI Motility Clinic|Subjects will have to stop medications affecting small bowel motility 7 days prior to the procedure. Risks expected in this washout period include recurrence of constipation predominant Irritable Bowel Syndrome symptoms- abdominal pain, bloating and constipation. Subjects will be instructed to call the study staff if symptom recurrence occurs.
741641|NCT01085630||19 enrolled patients were not randomized for the following reasons: progression during first-line therapy, patient refusal, new disease grade 4 brain tumor, patient expired prior to randomization, insufficient creatinine levels, > 1 week needed to randomize, prolonged adverse events, ineligible due to ECOG performance status being 2 or 3.
741642|NCT01085591||
741643|NCT01085539|All infants in the neonatal intensive care unit that required continuous pulse oximetry qualified for the study during the dates of January 2010 through April 2010.|
741644|NCT01085513||
741645|NCT01085500|General surgery residents were recruited from the Mayo Clinic, Rochester, Minnesota from January to September 2010.|
741646|NCT01085357|Subjects were screened and randomized at 24 investigative sites located in the United States.|of the 897 enrolled, 392 participants were exited prior to randomization as ineligible/withdrew consent. This reporting group includes all randomized participants (505).
741647|NCT01085344|Between June 26, 1997, and Jan 30, 2007, 56 boys were enrolled from 12 Canadian centres.|
741648|NCT01085331|First/last subject (informed consent): March 2010/September 2011. Last subject completed:May 2012.|Enrolled: 22 screened for eligibility; 6 were excluded (mainly non-fulfillment of inclusion or exclusion). 16 subjects were treated in a total of 4 centers (2 in Spain and 1 each in Belgium and Italy).
741649|NCT01085318|Recruitment took place at the clinic - June 16, 2010 through July 6, 2011|Relapsing Remitting Multiple Sclerosis (RRMS)Participants could not have received treatment within 3 months prior to Screening with interferon-beta-1a (Rebif®), IVIG or plasmapheresis
741650|NCT01085214|Participants were enrolled at 6 sites in the United States, from April 1, 2010 through July 28, 2011.|
741651|NCT01085201|Recruitment began on 4/19/10 and ceased completely on 3/26/13. In Stages 1, 2 and 2b, patients were recruited from the medical clinic. For Stages 3 and 4, in which subjects were treated during a pain crisis hospitalization, patients were first informed about the study in clinic, and reminded about the study after being admitted.|Patients who were assigned to Stages 1, 2 or 2b, in which subjects were studied at baseline (i.e. not in pain crisis), could be excluded if they experienced a pain crisis in the interim period between enrollment and their scheduled study date.
741652|NCT01085136||PD = Progression Disease
741653|NCT01085045|Conducted at 16 sites in Australia, New Zealand and the US from 24 March 2010 -28 October 2010. The entire study period was a maximum of 20 weeks. Chronic dosing (7 days), 4-period, 8-treatment, incomplete block, cross-over conducted in two parts.|Part A: 4-period, 8-treatment, incomplete block cross-over. Subjects randomized to 1 of 48 sequences, each subject received 4 of 8 possible treatments. Part B: 4-period, 4-treatment, full cross-over. Each subject randomized to 1 of 24 sequences and each sequence was assigned to at least 1 subject.
741654|NCT01085006||
741691|NCT01083472||
744771|NCT00918931|Recruitment Period: 6/5/2009 through 3/18/2010. All participants recruited at UT MD Anderson Cancer Center.|Three patients were registered and all of them received treatment.
741655|NCT01084772|The study was planned to enroll 196 subjects; 134 subjects were recruited to the study prior to its termination due to insufficient total enrollment. Subjects were enrolled from 21 June 2012 to 15 April 2014. Early termination was approved May 2014 and sites were officially notified of study termination in September 2015.|
741656|NCT01084759||
741657|NCT01084707|This was a five-arm cross-over trial, with subjects randomized to the order they received the different treatments and with analysis performed on valid pharmacokinetic data. Therefore, Number of Participants Analyzed in each arm represents the same subjects, and the total is not consistent with numbers provided in the participant flow module.|
741658|NCT01084694|Patients will be selected from our Program and will be undergoing evaluation for stem cell transplant.|Patients and caregivers were enrolled as dyads. Data was collected from both patients and caregivers.
741659|NCT01084668|A total of 46 participants were screened for this PMOS at 9 study sites in Austria. One participant did not meet entry criteria (screening failure), and 45 participants were enrolled and received treatment with adalimumab in the study.|Three participants were excluded from the database because they had been treated with adalimumab prior to their Visit 1. Statistical analysis has been performed for the 42 participants included in the All Treated population.
741660|NCT01084655|Participants took part in the study at 10 investigative sites in the United States from 22 July 2010 to 03 March 2016.|Male participants with a historical diagnosis of metastatic-castration resistant prostate cancer (mCRPC) were enrolled in this 2 part study to receive orteronel (TAK-700) along with docetaxel 75 milligram per square meter (mg/m^2) and prednisone 5 milligram (mg) twice daily (BID).
741661|NCT01084603||
741662|NCT01084551||
741663|NCT01084538||Safety population consists of 181 participants who received at least one dose of drug. Of those, 175 were included in the full analysis set. Six participants were excluded; five due to initial intact parathyroid hormone values less than 300 picograms per milliliter and one suffered a serious adverse event before the first evaluation (study visit).
741664|NCT01084499|Study period: Jan 2009 ~ May 2009|
741665|NCT01084278|Participants took part in the study at three investigative sites in the United States from 25 May 2010 to 28 February 2011.|Healthy participants, participants with mild, moderate or severe renal impairment and participants with end stage renal disease (requiring hemodialysis) were stratified to one of five treatment groups based on their renal status. All participants received 0.6 mg colchicine.
741666|NCT01084265||
741667|NCT01084252|Study participants were involved in the study from 10 June 2010 at 59 centers in 18 countries. A total of 418 participants were screened, of which 351 participants were enrolled. A total of 67 participants had screen failures due to failure to meet inclusion criteria.|Study consisted 2 phases: Phase 1 and Phase 2. Phase 1 was a dose escalation part of isatuximab to determine maximum tolerated dose (MTD). Phase 2 was conducted for efficacy and safety evaluation of isatuximab with or without dexamethasone. It was consisted of 2 stages: Stage 1 (comprised of 1a and 1b) and Stage 2.
741668|NCT01084239|Patient enrollment began on April 23, 2010, and ended on January 30, 2012, at nine hospitals in the United States.|
741669|NCT01084174||
741670|NCT01084148||Among the 237 enrolled patients: one patient not randomized. Among the 118 patients randomized into the V0034CR01B arm, one patient not treated. As such, among the 237 enrolled patients, 235 were treated, ie received test product at least once
741671|NCT01084135|8 participant started and completed the 12 week period. The protocol was amended and 23 subject enrolled into the 20 week amended period (22 completed).|42 subjects signed consent, 10 were screen failures, 1 withdrew consent prior to being assigned to an arm, 1 was withdrawn by PI after being assigned an arm for noncompliance, 30 completed study.
741672|NCT01084083|The study was activated on March 17, 2010 and closed to accrual on October 19, 2011, with an accrual of 90 patients from 16 ECOG-affiliated institutions.|
741673|NCT01084005||A total of 241 patients were randomised in a 2:1 ratio to receive treatment with linagliptin 5mg (n=162) or placebo (n=79). All randomised patients were treated.
741674|NCT01083979||
741675|NCT01083901|Participants were enrolled from Dec 2006 to Jan 2010. They were recruited from the greater Denver area using advertisements.|Volunteers who did not meet inclusion criteria were excluded from the study during the initial screening visits prior to randomization to the study arms.
741676|NCT01083849||761 participants were enrolled in the study, but two participants lacked information necessary for assignment to one of the analysis groups (pre-dialysis or dialysis). Hence, analysis was conducted with 759 participants.
741677|NCT01083810|These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.|
741678|NCT01083771||
741679|NCT01083758|Start date: 12 April 2010 Completion date: 8 August 2012|Prior to Visit 1 (Day 0), a wash-out period (up to 8 weeks, as defined by the exclusion criteria) was to be completed if the subject had been treated with antipsoriatic treatments or other relevant medication; 2 screening visits were planned.
741680|NCT01083732|20 patients were enrolled, 18 patients were entered and treated, 2 patients were screening failures.|Open-label, multicentre, non-randomised, uncontrolled, single arm study.
741681|NCT01083706||
741682|NCT01083693||A total of 162 participants were screened for this study. Of those, 161 are included in the analysis as one participant was a screen failure.
741683|NCT01083680|A total of 4107 participants were enrolled: 1621 in the full analysis set (FAS) population were analyzed for efficacy; 4107 were analyzed for safety.|
741684|NCT01083667|Patient were recruited from all sites and referrals received from other physicians. Subjects also contacted sites from ClinicalTrials.gov posting|
741685|NCT01083654|Participants were recruited from February 22, 2010, to May 26, 2011 at the Menominee Tribal Clinic (MTC). The MTC Wellness Director or designee screened potential participants (adult American Indian smokers). Informed consent and HIPAA authorization were obtained at the Enrollment Visit.|
741686|NCT01083641|This multicenter phase 2 study was conducted through the Wisconsin Oncology Network. Subjects were recruited from February 2010 through March 2013.|
741687|NCT01083628||
741688|NCT01083602||
741689|NCT01083576||
741692|NCT01083368|Subjects were recruited from medical clinics from 3/2009 to 7/2011|22 participants were enrolled, but only 21 treated because one participant withdrew before start of protocol therapy.
741693|NCT01083316||
741694|NCT01083199||
741695|NCT01083186||
741696|NCT01083173||
741697|NCT01083160||
741698|NCT01083121||
741699|NCT01082965||
741700|NCT01082952|recruitment started January 2010 and ended July 2011. Recruitment was all in King Khalid Hospital, Riyadh, Saudi Arabia|
741701|NCT01082939|Recruitment Period 12/6/02- 9/22/06; all participants were registered at The University of Texas M.D. Anderson Cancer Center.|
741702|NCT01082874||
741703|NCT01082640|Participants took part in the study at 46 investigative sites in the United States from 09 April 2010 to 31 May 2012.|Participants meeting the American Rheumatism Association (ARA) diagnostic criteria for gout (subjects with tophi were excluded). were randomized to 1 of 3 arms in a 1:1:1 ratio to receive either febuxostat 40 mg/80 mg once daily (QD) or febuxostat 30 mg twice daily (BID) or placebo for up to 12 months.
741704|NCT01082614||
741705|NCT01082588|All participants were recruited from the Massachusetts General Hospital Schizophrenia Clinical and Research Program.|
741706|NCT01082575|Patients were recruited from February 12, 2010 to June 25, 2010 from an acute care hospital.|All enrolled patients were included into the trial. This was an observational study.
741707|NCT01082380||
741708|NCT01082367|Participants were randomized 1:1 to TOBI or placebo. After 1 treatment cycle, participants who were P.a positive entered an OL phase. Participants who were P.a negative entered cross-over treatment.|The cross-over was optional. At the end of the cross-over or OL phase, participants who were P.a positive terminated the study. P.a negative participants entered follow-up.
741709|NCT01082328||
741710|NCT01082211||
741711|NCT01082159|Patients were enrolled from July 2008 through January 2010.|
741712|NCT01082081|Participants were recruited at the clinical site.|Of 438 screened participants, 138 were considered to be screen failures. Remaining 300 were randomized to study treatments.
741713|NCT01081951|The first patient was enrolled on 12-Feb-2010. The last patient was enrolled on 15-Jul-2010. Patients were enrolled at 43 sites in 12 countries: Australia, Belgium, Canada, Czech Republic, Germany, Italy, Japan, the Netherlands, Panama, Spain, the UK and the USA. 173 patients were screened and 162 patients were enrolled to receive treatment.|Patient randomisation was stratified(using an interactive voice response [IVR]system) based on:1) number of prior platinum-containing treatment lines received(1or>1) and 2)time to disease progression following completion of the previous platinum-containing therapy(>6to<=12 months or>12 months).Six patients in the C6/P arm did not receive treatment.
741714|NCT01081912||Out of 510 subjects treated with Hydrocodone Bitartrate Extended Release (HC-ER) capsules in the Conversion/Titration Phase, 208 subjects discontinued early and 151 subjects were randomized into each of the two treatment groups (Maintenance HC-ER Treatment and Placebo Treatment).
741715|NCT01081886||
741716|NCT01081873||
741717|NCT01081834|This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. The study was conducted between 08 February 2010 and 18 August 2011 and recruited patients from 90 study centers in 17 countries worldwide.|678 patients were enrolled into the study; 587 patients in the main study and 91 patients in the high glycemic substudy. 584 patients in the main study and all 91 patients in the high glycemic substudy received at least one dose of study drug and were included in the modified intent-to-treat (mITT) analyses sets and the safety analyses sets.
741718|NCT01081795||
741719|NCT01081769||After randomization patients enrolled in a 2-week oral treatment phase and were considered part of the whole Intent-to-Treat population (Whole ITT). Five patients did not receive study medication after randomization and were excluded from the whole ITT. Only responders were considered for continuation in the Core treatment phase (Core ITT).
741720|NCT01081678|This study was conducted at 63 centers in 22 countries in Eastern Europe, Western Europe, India, North America, Latin America, Australia, New Zealand and Hong Kong.|"Participants were randomized in a 2:3:3:3 ratio to 1 of 3 romosozumab treatment groups or placebo.
~Randomization followed operative fracture repair and was stratified by type of fracture, type of fixation device and age at entry. There were 7 randomization strata."
741721|NCT01081665||
741722|NCT01081626||
741723|NCT01081301|In Saskatchewan, the Palliative Care Admission team in Regina Qu'Appelle Health Region and nurses at the Saskatchewan Cancer Agency also identified potential participants. In Alberta, the Alberta Health Services Cancer Care and Community Cancer Clinics in rural communities also identified potential participants.|Exclusion criteria were a) women who were cognitively impaired as determined by the recruitment team at the site, b) women otherwise unable to participate, in the opinion of the recruitment team and c) women caring for a family member who has a diagnosis of advanced cancer as well as dementia.
741724|NCT01081262|The study was activated on 12 October 2010 and closed to patient accrual on 28 October 2013.|
741725|NCT01081249||
741726|NCT01081145||
741727|NCT01081132||
741728|NCT01081041||Two-part study: Part 1 (single arm, safety lead-in) then Part 2 (parallel treatment comparison). All participants to complete 6 cycles of combination therapy then, if eligible, monotherapy. Participant flow presents those who completed study (died); those who were alive or death status unknown at data cut-off considered to not have completed study.
741729|NCT01080976||
741730|NCT01080807|385 patients at 45 centers in the US met entry criteria and were considered eligible for enrollment into the study; 2 of these patients enrolled twice under different identification numbers. Of the 383 patients enrolled, 371 received at least 1 dose of study drug and were evaluated for safety; 12 patients withdrew before taking any study drug.|The study consisted of a 1- to 3-week screening period, a 1-week baseline period (followed by randomization), and a 6-week double-blind treatment period.
741731|NCT01080794|Subjects were screened and enrolled from 6 clinical centers in the United States and 1 clinical center in Canada.|We enrolled 61 subjects into this study with a previous enrollment goal of 85. Interim analysis revealed that 61 subjects provided sufficient power for data analysis, therefore we stopped recruitment.
741732|NCT01080768||
741733|NCT01080716|Volunteers were recruited by contacting people from a list of potential volunteers from previous studies, by friend to friend contact, by internal announcement or by presentation booth in the university, community or blood donor sites. Recruitment and screening was performed by the staff at the Vaccine Trial Center, Mahidol University.|Part 1 - total of 20 volunteers (14 vaccinees and 6 controls) Part 2 - was started approximately 60 days after WRSS1 vaccination. 10 vaccinees from part 1 and 10 naïve controls
741734|NCT01080677||
741735|NCT01080625|Of the 128 eligible candidates, 96 patients were enrolled in this study from Mar 2010 to Oct 2010 at SNUH.|"Excluded(n=32) Children n=13 Coronary artery disease n=2 Valvular heart disease n=2 Atrial fibrillation n=1 Enrolled in other trial n=2 refusal to participate n=12
~Randomized (n=96) intraop portal vein rupture n=1 data recording error n=1 procedure failure n=1
~Analyzed n=93 (n=31 er each group)"
741736|NCT01080391|Participants were enrolled from 14 July 2010 to 15 March 2012. The primary analysis was conducted using a data cut-off date of 16 June 2014 and the final safety analysis after last subject last visit date (05 December 2017).|Eligible participants were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by β2 microglobulin level (< vs. ≥ 2.5 mg/L), prior bortezomib exposure (no vs. yes), and prior lenalidomide exposure (no vs. yes).
741737|NCT01080326|Subjects were enrolled between February 2010 and February 2012 at Mayo Clinic in Rochester, Minnesota.|
741738|NCT01080300||A total of 600 subjects were randomly assigned to treatment: 302 in G-ER 1800 mg group and 298 in placebo group. Of these 600 subjects, 595 subjects (300 in G-ER 1800 mg group and 295 in placebo group) received study treatment and were included in the safety population, and 593 subjects were included in the intent-to-treat (ITT) population.
741739|NCT01080261|Enrollment of 60 patients was planned and 60 patients were enrolled at 14 sites in Japan from February 8, 2010 to June 15, 2010.|
741740|NCT01080248|The study opened to participant enrollment on 08/26/2010 and closed to participant enrollment on 09/27/2011.|
741741|NCT01080209||Patients enrolled in this extension study from the following parent studies: 190342-027D, 190342-028D, 190342-030D, 190342-031D, 190342-032D, and 190342-036. No treatment was administered in this study, so the treatment groups reflect the treatments received in the parent studies.
741742|NCT01080196||
741743|NCT01080131||
741744|NCT01080118|Medical students and intern trainees with no prior experience in laryngoscopy on clinical rotation in the Department of Anesthesiology were recruited to participate. Written informed consent was obtained from all the study participants.|Trainees received a structured lecture in airway management followed by training in laryngoscopy skills on a mannequin, and required to demonstrate proficiency. Trainees were then randomly assigned to attempt their first two intubations on different patients using either the optical or rigid laryngoscope with a MacIntosh size 3 blade.
741745|NCT01079988|Study Initiation Date: 24 February 2004 (first patient, first visit) Study Completion Date: 21 December 2004 (last patient, last visit) Study Centres: 9 clinical centres in Canada|Subjects who satisfied the study's entry criteria were assigned to receive one of five treatment regimens involving accepted therapies for moderate to severe psoriasis
741746|NCT01079962||A total of 228 participants were screened for the study, out of which 19 were screen failures and 209 participants received the study medication.
741747|NCT01079949||
741748|NCT01079936|Recruitment Period: March 01, 2010 to April 18, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.|Following Phase I portion of study, participants were assigned using adaptive randomization to 1 of 4 dose levels in Phase II. Out of 61 participants consented, 2 participants were ineligible for study due to first remission status and 2 participants did not receive stem cell transplant due to other issues and are not included in study demographic.
741749|NCT01079832|Between July 24,2009 and September 7, 2011, 50 patients were recruited from University Hospitals in Cleveland Ohio.|
741750|NCT01079806||Of 228 patients enrolled, 43 no longer met study criteria, 4 withdrew consent, and 1 withdrew for surgery. While the primary endpoint analysis was based on a randomized sample size of 123 participants, the overall study population was augmented to 180 to meet global regulatory requirements. All 180 randomized patients received study drug.
741751|NCT01079741||
741752|NCT01079598||
741753|NCT01079390|Forty-four acupuncture naïve patients aged 43-70 with a diagnosis of chronic osteoarthritis in the right and/or left knee participated in the study. 30 (13 females) completed all study procedures. Fourteen subjects did not complete the study. All subjects were recruited form the Boston area over the course of the past 3 years.|Fourteen subjects did not complete the study due to problems with scheduling (6), ineligibility at screening (3), disinterest (2), claustrophobia (1), or inability to adhere to study requirements in scanner (2). Of the 14 subjects who dropped, four dropped out after randomization.
741754|NCT01079299|52 subjects were treated, IPC n=27, Control n=25|
741755|NCT01079234|"The main/extension trial periods were conducted at 71/68 sites in 6 countries:
~Belgium (5/5 sites), Germany (7/7 sites), Norway (5/5 sites), Poland (5/5 sites), United Kingdom (UK) (12/11 sites), and United States of America (U.S.) (37/35 sites). 57 patients did not participate in the extension trial."|All subjects who completed the 26-week main trial and were found to be eligible for the extension trial were offered to participate in the 26-week extension trial (NCT01079234). Total duration of trial was up to 52 weeks (26 weeks+ 26 weeks) with two times 7-12 day follow-up periods.
741756|NCT01079195||15,873 participants enrolled in the study. Of these, documentation was available for 15,436 participants. 743 participants were excluded for the following reasons: No Tarka therapy documentation (739) and no follow-up data provided (4), leaving a study population of 14,693. No group assignments were made as the study design was observational.
741757|NCT01079182||
741758|NCT01079143||EMT+: ≥ 10% tubular cells showing de novo expression of vimentin (or translocation of β catenin if inconclusive) into the cytoplasm EMT-: < 10% tubular cells showing de novo expression of vimentin (or translocation of β catenin if inconclusive) into the cytoplasm
741759|NCT01079130||The study consisted of a 14 day run-in period. 511 participants were randomized but only 502 participants received study drug.
741760|NCT01078974|A total of 7 participants were recruited at the DFCI medical clinic between 9/22/2010 and 4/3/2012.|
741761|NCT01078922||
741872|NCT01074307||
744772|NCT00918879||
741762|NCT01078909|Recruitment and screened occured between September 2011 and March 2012 at the Clinical Research Center at Penn State University.|A computer-generated randomization scheme was developed in advance. The randomization scheme was stratified by sex and age and used a balanced block size of 5 to ensure even distribution among treatment groups. Using this randomization scheme, eligible participants were assigned to blinded treatments at the baseline visit by the study coordinator.
741763|NCT01078844||4 participants were enrolled in this study. It was terminated prematurely and the P.I. was never un-blinded. In an attempt to enter the information which was obtained within the confines of the system, all enrollment information and baseline characteristics have been entered into the experimental arm.
741764|NCT01078805||
741765|NCT01078753||"174 subjects consented and entered the 14-day screening period during which Baseline characteristics regarding enuretic episodes were established. Eligible patients who met the criterion were randomized 1:1 to receive either desmopressin or matching placebo.
~Randomization was stratified by gender, age and number of wet nights at Baseline."
741766|NCT01078675|250 patients with FH were screened. Additionally, 65 healthy siblings (HS) were enrolled. HS refers to healthy subjects that were siblings of either the study participants or other paediatric patients with HeFH that were not participating in the study. HS were enrolled to have assessments of cIMT, but did not participate further.|
741767|NCT01078662|This study was conducted at 13 sites across Israel, Germany, Spain, Australia, USA, Sweden. Enrolment started in Feb 2010 and was completed in Jul 2012. In total, 318 patients of different cancer types were enrolled out of which 298 patients received olaparib.|Patients >17 years age with histologically and/or cytologically confirmed malignant solid tumours, refractory to standard therapy for which no suitable effective/curative therapy. Patients with confirmed deleterious or suspected deleterious BRCA mutation, Eastern Co-operative Oncology Group performance status ≤2 and life expectancy of ≥12 weeks.
741768|NCT01078623|"This study was conducted at a total of 28 sites (4 sites in Czech Republic, 5 sites in Germany, 3 sites in Hungary, 4 sites in Poland and 12 sites in Romania)
~The first patient was screened in February 2010 and the last patient visit was in September 2010"|"A total of 176 patients were screened of whom 135 were assessed as eligible and were randomized into the study
~There were 41 screen failures, the main reason being non-fulfilment of inclusion/exclusion criteria"
741769|NCT01078584|A total of 7993 participants were enrolled at 568 study sites in Canada over a period of 24 months.|Although 3 participants were considered to have violated the protocol because they were not adults (ie, </= 18 years old), they were included in the Intention-to-Treat (ITT) cohort.
741770|NCT01078571||
741771|NCT01078558||A total of 5940 participants (2845 with rheumatoid arthritis [RA], 1128 with psoriatic arthritis [PsA], and 1967 with ankylosing spondylitis [AS]) were enrolled. Twenty of these participants were younger than 18 years old (9 RA participants, 1 PsA participant, and 10 AS participants); these participants were not included in any analysis.
741772|NCT01078545||
741773|NCT01078454|Participants were recruited from ECOG member institutions between November 1, 2010 and September 7, 2012.|
741774|NCT01078441|Two patients were enrolled from ECOG member institutions between September 14, 2010 and June 26, 2012. The study was closed early due to weak accrual.|
741775|NCT01078402|Investigational sites in 7 countries participated in this study: Croatia, Hungary, Israel, Poland, Romania, Slovakia and Ukraine.|Out of 809 participants recruited, 789 were included in the statistical evaluation dataset (SES). 20 participants were not included due to no documented Humira therapy and/or missing primary diagnosis.
741776|NCT01078389|Participants took part in the study at 65 investigative sites in the United States from 10 March 2010 to 3 September 2013.|Participants with a diagnosis of gout were enrolled equally in 1 of 2 treatment groups, once a day placebo or febuxostat 40 mg or 80 mg based on serum urate levels.
741777|NCT01078376|Participants took part in the study at 6 sites in the United States and 3 sites in the United Kingdom from 10 May 2010 to 10 July 2013.|Children between the ages of 1 to 16 years (including up to their 17th birthday) with hypertension and gender-matched healthy adults aged 18 to 45 years, inclusive, were enrolled in 1 of 3 cohorts.
741778|NCT01078363||
741779|NCT01078298||
741780|NCT01078246||The analyses in this study are based on data collected from a cohort of human immunodeficiency virus (HIV-1)-infected participants in a setting of routine clinical care at the Kaiser Permanente medical centers in California, United States. Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.
741781|NCT01078233||The analyses in this study are based on data collected from a cohort of HIV-1-infected participants in a setting of routine clinical care in Europe (EuroSIDA Cohort Study). Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.
741782|NCT01078220||
741783|NCT01078207|From Feb 2010 to Oct 2010 adults at high risk for obstructive sleep apnea scheduled for general surgery requiring analgesia with an expected over night hospital stay were recruited from the hospital clinic.|
741784|NCT01078168|University Medical Centre of the Johannes Gutenberg University, Mainz, and University Medical Centre, Rostock, May 2010 to January 2013|neuropsychiatric testing, general exclusion of e.g. depression or severe diseases affecting the trial
741785|NCT01078155||
741786|NCT01078116||
741787|NCT01078090||
741788|NCT01077973||
741789|NCT01077960|Study Initiation Date: 03 Feb 2005 (date of first subject, first dose) Study Completion Date 04 Jan 2006 (date of last subject, last visit) 26 study centers in the United States and British Columbia participated in this study, with each center enrolling at least one subject into the study.|Any subject who was enrolled in Serono Study 24380, assigned to Group A, and fully completed all study visits without major protocol violations was to be allowed to enroll in Study 25373
741790|NCT01077921|Subjects were recruited from the Duke adult sickle cell clinic. Those that consented underwent a screening visit to determine eligibility. If eligible they were enrolled on the study and received study drug within 30 days of screening|Eighty-four patients were approached for the study, of those 28 declined to participate, 14 remained undecided. Forty-two patients consented. Thirthy-one of those consenting were enrolled and 27 randomized to the study.
741791|NCT01077856||
745192|NCT00894387||"Of the 2134 screened patients (including
~1 patient who was screened twice), 1639 patients were randomized."
741792|NCT01077830|All participants from five countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who completed the SEAS base study and who were known to be alive at the end of the base study.|Of the 1873 participants in the SEAS base study, 1392 were eligible for inclusion in this follow-up study. Of these 1392 participants, 33 were excluded due to incomplete base study data or because follow-up data could not be obtained, leaving 1359 participants in the follow-up study.
741793|NCT01077817|Participants were not recruited nor enrolled in this study. This study is a retrospective observational study. Data from the GPRD were anonymized and used to develop participant cohorts. All diagnoses and treatments were recorded in the course of routine medical practice.|684,815 women in the General Practice Research Database (GPRD) formed the Overall Study Population. These women met the demographic criteria of being age 55 or older, were born between 1922 and 1955, had more than 720 days experience in the GPRD and at least one of those days fell between 1996 and 2008.
741794|NCT01077804||
741795|NCT01077739||
741796|NCT01077713||
741797|NCT01077622||
741798|NCT01077596|Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.|
741799|NCT01077544||
741800|NCT01077518||
741801|NCT01077401||
741802|NCT01077375|Recruitment occurred over an 8 month period from February 2010 to September 2010 at 25 study centers in the United States. Last patient last visit occurred on December 22nd, 2010.|"All participants were given an open-label treatment of duloxetine 60 mg once daily for a two week period before randomization.
~Patients randomized to placebo received 1 week of duloxetine 30 mg to effect a duloxetine down-taper. Patients randomized to milnacipran received 1 week of placebo capsules to maintain the blind."
741803|NCT01077362||
741804|NCT01077323||
741805|NCT01077310||
741806|NCT01077284|Participants took part in the study at 24 investigative sites in the United States from 12 February 2010 to 21 November 2011.|Participants with hyperuricosuria and calcium oxalate stones were randomized to 1 of 3 treatment groups in a 1:1:1 ratio to receive placebo, allopurinol or febuxostat.
741807|NCT01077271||
741808|NCT01077258||
741809|NCT01077193|The enrollment period began in October 2009 and ended in November 2010 at three sites (1 academic site, 2 medical clinics).|No significant events were involved - subjects were evaluated for inclusion and exclusion criteria and proceeded to surgery if they qualified. This is a 1-arm trial.
741810|NCT01077154|Participants were enrolled at 407 centers in Australia, Western Europe, Eastern Europe, Israel, North America, Asia, South America, South Africa, and Turkey from 02 June 2010 to 24 August 2012.|Participants were randomized in a 1:1 ratio to 1 of 2 groups. Randomization was stratified based on breast cancer therapy/lymph node (LN) status, hormone receptor status, human epidermal growth factor receptor 2 (HER-2) status, age, and geographic region.
741811|NCT01077128||
741812|NCT01077076||
741813|NCT01077063||
741814|NCT01077050|"Recruitment was conducted at five (5) US investigational sites and at seventeen (17) European investigational sites.
~Recruitment period 2010-2011. In 2012 the last histological analysis was performed."|Potential study subjects were screened according to the inclusion/exclusion criteria. All study eligible skin lesion(s) were then examined with the investigational device, photographed and removed by an excisional biopsy.
741815|NCT01077024||
741816|NCT01076985||
741817|NCT01076972||
741818|NCT01076959|The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the Pharmaceuticals and Medical Devices Agency (PMDA).|The study was completed when the PMDA had completed their review. A total of 7972 patients were registered and case report forms were retrieved for 7891 patients; 151 patients were excluded from the analysis because the case report forms were either duplicated (n=150) or the patient was included in another survey (n=1).
741819|NCT01076686||
741820|NCT01076647|The trial was conducted at 89 sites in 7 countries: Bulgaria, Canada, France, Hungary, Netherlands, Romania, and United States.|
741821|NCT01076543||
741822|NCT01076504||81 patients were enrolled but 1 patient was hospitalized prior to receiving any protocol treatment and was never treated. 80 patients included in the analysis
741823|NCT01076452|299 subjects were enrolled into the study from May 2002 to September 2006 at 13 clinical sites including 7 VA Medical Centers and 6 affiliated university medical centers.|
741824|NCT01076400|Due to the early termination of the study by the sponsor, no participants were enrolled in Part 2 of the study.|
741825|NCT01076361|All enrolled patients with at least 1 Model 4968 lead implanted|
741826|NCT01076348|The study utilized centers that had implanted model 4965 leads in adult subjects to obtain information regarding safety, lead events, and lead survival.|
741827|NCT01076335|Recruitment Period: Enrollment took place from 21 April 2005 to 31 March 2008. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the 40 enrolled, one participant (2.5%) declined presurgical therapy after enrollment and was excluded from subsequent analyses.
741828|NCT01076296||
741829|NCT01076283|Potential participants came for an in-person screening (Visit 1) at the Brown University Center for Alcohol and Addiction Studies (CAAS). At Visit 2 (day 1), participants were randomized to either baclofen or active placebo by using a 3-urn variable procedure (Stout et al., 1994), i.e. gender, FH of alcoholism and baseline drinks per drinking day.|19 participants signed the consent document; 5 of them did not satisfy the protocol-specific inclusion/exclusion criteria, therefore they were excluded from the trial. The remaining 14 subjects were assigned to the study groups.
741830|NCT01076270||
741831|NCT01076244|Patients were enrolled through one site (Center for Pain Relief) between March 2010 to January 2011.|
741832|NCT01076205|Adults with rheumatoid arthritis (RA) were enrolled at 326 clinical centers in Germany and seen during regular visits for routine clinical care.|
742014|NCT01066585|Participants were enrolled and treated from 8 March 2010 to 9 June 2010 in 8 US clinical centers.|A total of 410 participants who met the inclusion and exclusion criteria were enrolled and treated.
741833|NCT01076192||A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).
741834|NCT01076179||
741835|NCT01076166||A total of 337 participants were enrolled in the study. 308 were analyzed as 29 participants had protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2).
741836|NCT01076153||A total of 760 participants were enrolled in the study. 694 were analyzed as 66 participants had protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3).
741837|NCT01076088||In total, 744 participants were randomized to treatment. Of these 744 participants, 1 participant, assigned to the placebo group, did not receive study medication. This participant was not included in the safety analyses.
741838|NCT01076075||762 participants were screened, 335 participants were excluded, and 427 participants were randomized. There was a single-blind run-in prior to randomization.
741839|NCT01076036|February-March 2011 at CORBIC, Envigado, Colombia|
741840|NCT01076010|Subjects were enrolled at 55 sites in 14 countries. Study Period from 24 May 2010 (First Subject Dosed) to 04 July 2014 (Last Subject Last Visit).|All participants underwent inclusion and exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures. All the study assessments were performed as per the schedule of assessment.
741841|NCT01075984||All participants who started the study were eligible to enter the follow-up phase, whether or not they completed the treatment phase.
741842|NCT01075971||
741843|NCT01075958|Recruitment took place on the Northumbria University campus via posted adverts and email messages sent using the university distribution lists. Recruitment took place in 2 waves; the first taking place between July 31 - November 8 2007, and the second between March 26 - September 9 2008.|Participants from whom a venous blood sample could not be obtained were not entered into the analysis.
741844|NCT01075815||One out of 76 randomized participants did not receive study medication.
741845|NCT01075763||
741846|NCT01075685|Recruitment period: Oct 27 to Dec 15, 2009 Recruitment was conducted via Internet.|
741847|NCT01075646|Study recruitment took place at the hospital Universitari de Bellvitge in Barcelona, Spain, from April 2010 to April 2012 in the case of colorrectal surgery. In hepatic surgery the study recruitment took place at the same hospital, from April 2010 to June 2014.|In colorrectal surgery 117 patients were assessed for elegibility. Of these 50 patients were excluded before randomization including 23 with exclusion criteria and 18 with a surgical or organization reason. In hepatic surgery 108 patients were assesed for eligibility, 9 patients were excluded with a surgical reason.
741848|NCT01075412||
741849|NCT01075399|A total of 50 patients were enrolled into the study. There were 42 of 50 patients received at least one dose of [F-18]HX4 and had safety data collected. There were 39 of 50 patients completed two pre-treatment [F-18]HX4 PET/CT scans and were included in analyses to assess reproducibility.|
741850|NCT01075347||
741851|NCT01075321||
741852|NCT01075282||
741853|NCT01075256|Participants were recruited at the clinical site.|During the first 4 weeks of the study all participants brushed with an acclimatization toothpaste (sodium fluoride [NaF] toothpaste containing 1100 parts per million [ppm] fluoride [F]) for maintaining wash-out period and standardizing the oral conditions.
741854|NCT01075243|Participants were recruited at the clinical site.|Of 722 screened participants, 321 were considered to be screen failures. Remaining 401 were randomized to study treatments.
741855|NCT01075217|Study start date: April 2010 (first patient received study agent); Study completion date: December 2011 (final collection date for primary outcome measure) This study was conducted in 6 clinical sites across the United States and 1 in Canada.|
741856|NCT01075204||
741857|NCT01075191||
741858|NCT01075178|Infants diagnosed with hemodynamically significant congenital heart disease who were less than 24 months of age when first dosed with palivizumab (CASES) were compared for the occurrence of serious adverse events over an 8-month chart review period with matched infants who did not receive palivizumab during the first 24 months of life (CONTROLS).|
741859|NCT01075152||
741860|NCT01075100||
741861|NCT01075087|Subjects were enrolled consecutively from 03/2010 through 07/2012 in the pre operative area of the hospital.|26 were assessed for eligibility. 7 were excluded ( 4 did not meet inclusion criteria and 3 refused to participate).
741862|NCT01075074|Recruited from Prentice Women's Hospital consecutively from 04/01/2010-02/2011|
741863|NCT01075048|A total of 131 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 40 clinic sites (24 in the United States and 16 in Europe).|Of the 131, 9 participants enrolled into the Phase 1 cohort and 122 participants randomly assigned to ARQ 197 or placebo treatment in Phase 2. In Phase 2, 1 enrolled participant was not treated and therefore not included in the Safety Analysis Set.
741864|NCT01074944|The study was conducted at 45 centers in 17 countries between 1 June 2010 and 6 October 2015. A total of 219 participants were screened, out of which 170 entered into the lead in period (LIP). Remaining 48 participants were screen failures and 1 participant withdrew before entering into the LIP.|Participant flow divided into 4 periods: LIP:to assess randomization criteria. Primary analysis period (PAP):to assess therapeutic efficacy at 2 dosing regimen in randomized participants. Long-term treatment period (LTTP): to assess long term efficacy. Extended treatment period (ETP):those who were non-randomized after LIP continued in this period.
741865|NCT01074931||
741866|NCT01074658|Start Recruitment March 2010 > End Recruitment July 2011|
741867|NCT01074554||One patient who was randomized to the CLEAR regimen did not have lesions compatible with sarcoidosis at baseline. This patient did not proceed with study participation and was removed from number of patients that started the study.
741868|NCT01074502||
741869|NCT01074463||
741870|NCT01074450||
741871|NCT01074437||
741873|NCT01074268|The trial was conducted at 55 sites in 7 countries: Brazil (2), Finland (8), India (10), Italy (6), Japan (15), Macedonia (1) and United Kingdom (13). For the extension trial, one trial site in Italy did not enroll any subject since approval was not obtained before the start of the trial from the IEC.|All subjects who completed the 26-week main trial (NN1250-3585, NCT01074268) and were found to be eligible for the extension trial were offered to participate in the 26-week extension trial (NN1250-3725). The total duration of treatment was 52 weeks (26 weeks + 26 weeks), separated by 1 week of follow-up from the main trial.
741874|NCT01074255|South Korean hospitals provided 3,546 participant's case report forms, 9/18/2006-1/22/2012. 407 participants were excluded: 201 violated dosage/administration, 173 lost to follow-up, 15 duplicated participants, 10 assessed before the contracted date, 3 previously received EMEND, 3 violated inclusion/exclusion criteria, and 2 didn't receive EMEND.|
741875|NCT01074242||
741876|NCT01074229||
741877|NCT01074216||
741878|NCT01074177||
741879|NCT01074164||
741880|NCT01074125||3 patients were randomized, but withdrew before initiating study treatment
741881|NCT01074099||
741882|NCT01074047|This was a multicenter, international Phase 3 study conducted at 107 investigational sites in 18 countries including South Korea, China, Taiwan, Australia, Canada, United States, Poland, Russia, Czech Republic, Israel, France, Italy, Spain, Germany, United Kingdom, Belgium, Austria and the Netherlands.|
741883|NCT01074034||
741884|NCT01074008||
741885|NCT01073943||
741886|NCT01073930||
741887|NCT01073865|Totally 286 patients were screened to the study from 58 centres in the following 6 countries: India, Japan, Korea, Philippines, Thailand, Taiwan. The first patient entered the study on 26 February 2010 and the last visit of last patient was on 19 September 2012.|286 patients were screened and 222 patients were randomized (109 in ZOLADEX 10.8 mg, 113 in ZOLADEX 3.6 mg)
741888|NCT01073657|Veterans were referred to the study by clinicians and other sources such as Veterans Upward Program and were consented and baselined over a 9 month period.|
741889|NCT01073631||There were 543 participants enrolled in this study. Of these, 230 participants were treated with the Vfend tablet formulation only, and 313 participants were treated with Vfend tablet and Vfend intravenous (IV) formulations sequentially or vice versa. These 313 participants are also included in Study A1501067 (NCT01073618).
741890|NCT01073618||There were 692 participants enrolled in this study. Of these, 379 participants were treated with the IV formulation of Vfend only, and 313 participants were treated with Vfend IV and Vfend tablets sequentially or vice versa. These 313 participants are also included in study A1501068 (NCT01073631).
741891|NCT01073605||
741892|NCT01073566||
741893|NCT01073462||
741894|NCT01073449||
741895|NCT01073293||
741896|NCT01073267|Recruitment period: February 19, 2010 to April 19, 2011. All participants recruited at The University of Texas MD Anderson Cancer Center.|
741897|NCT01073163||Sixty-five patients were screened for this study; 8 did not meet eligibility criteria, and 3 were not enrolled for other reasons.
741898|NCT01072929|"Four geographic regions that include countries with similar clinical practices.
~Region 1: USA and Canada
~Region 2: Bulgaria, Ukraine, Poland, and Serbia
~Region 3: Australia, France, and Spain
~Region 4: Argentina"|Participants were randomized (1:1) to receive150 mg/day armodafinil or matching placebo. The 200-mg/day armodafinil treatment group was discontinued per protocol Amendment 03. Randomization was stratified on the basis of the mood-stabilizing medication and region of the world.
741899|NCT01072877||
741900|NCT01072773||
741901|NCT01072669||
741902|NCT01072656||11 participants signed informed consent, 10 participants had surgery, 1 participant dropped the study prior to randomization phase, 9 participants were analyzed.
741903|NCT01072643||22 patients were screened, but 18 were determined to be not feasible, only 4 participants were enrolled and started the study at drug level 1 (bolus of 1mcg/kg and infusion at 0.7mcg/kg/hr); There was no escalation to either dose level 2 or dose level 3 as we did not reach enrollment target of 8 subjects in dose level 1
741904|NCT01072630|Region 1: USA and Canada Region 2: Eastern European countries, Kyrgyzstan, Mongolia, Uzbekistan, Cyprus, Greece, and Turkey Region 3: Central and Northern European countries, Andorra, Australia, Iceland, Malta, Monaco, San Marino, and Vatican City Region 4: Rest of World|Participants were randomized (1:1) to receive150 mg/day armodafinil or matching placebo. The 200-mg/day armodafinil treatment group was discontinued per protocol Amendment 03. Randomization was stratified on the basis of the mood-stabilizing medication and region of the world.
741905|NCT01072617||
741906|NCT01072539|Participants were enrolled between May 2010 and April 2015 from Korean health care centers.|
741907|NCT01072526|Study was conducted Dec 2007 to Sept 2008. Participants were evaluated in the Mason Eye Institute and underwent 4 measures of dry eyes at baseline and after 6 weeks of therapy.|Participants will stop all common artificial tear use for 2 weeks prior to baseline examination and randomization.
741908|NCT01072500|1,635 participants were randomized over 21-months, with the target of 1,600 reached late Nov 2011. The 1st randomization occurred 3/12/10, and the final randomization on 12/27/11. Participants in the recruitment pipeline completed screening and testing visits and were randomized; hence, the total randomized exceeded the target.|
741909|NCT01072448||
741910|NCT01072409||
741911|NCT01072396||The study has two stages, in the first (exploratory) stage, the Control group (Healthy volunteer) is compared to the age-gender matched COPD patients in terms of baseline characteristics. In the second (confirmatory) stage, Placebo and Tiotropium are compared using a cross-over. Since the first stage is exploratory it is not reported.
741912|NCT01072357||
741913|NCT01072344||The study has 3 phases. The 1st phase is open label cham.(N=179), subjects meeting response criteria enter 2nd phase (N=93), the consolidation phase of open label chamomile. At the end of 2nd phase, if subjects still meet response criteria, they will enter the 3rd phase (N=93). In the 3rd phase, subjects will be randomized to chamomile vs. placebo.
741914|NCT01072331||
741915|NCT01072201||
741916|NCT01072188||
742015|NCT01066546||
741917|NCT01072175|This study was conducted in 16 sites: Australia (2) and USA (14)|The study was comprised of Parts A, B, and D, which constitute the Phase I part of the study, and Part C, which constitutes the randomized Phase II part of the study. Participants did not enroll in all parts of the study sequentially. Each part of the study was comprised of a separate population of participants.
741918|NCT01072149||Following screening and a 2-week Run-in Period, during which all participants received placebo, participants were randomized to receive 2 of the 3 strengths of study medication and placebo in the Treatment Phase of the study, which consisted of three 28-day treatment periods, each separated by a 14-day washout period.
741919|NCT01072136|Participants were recruited from STD or family planning clinics in New Orleans, LA, Birmingham AL, Jackson, MS, and Los Angeles CA between March 2010 and May 2011.|
741920|NCT01072032||
741921|NCT01072006|VANCHCS clinic recruitment 2011-2015|This was not a clinical trial so there was no random assignment to groups. Rather, patients fell into distinct groups based on their clinical history (e.g., history of TBI or PTSD or both or neither).
741922|NCT01071993|Participants were recruited and signed consent. No drugs were supplied to participants. Study sponsor could not provide study drugs to participants due to cost restraints.|Prior to assigning participants to specific arms of the protocol, site was informed that the study drug was no longer available.
741923|NCT01071954|This study was conducted at 28 centers in Australia, Canada, Spain, and the United States. Participants were enrolled from 30 December 2009 until 19 February 2015.|Pediatric patients who completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with immune (idiopathic) thrombocytopenia purpura (ITP) were eligible to participate in this study.
741924|NCT01071915|The patients were recruited from 11 sites in Korea. The study was conducted between 08 March 2010 (FPFV) and 07 November 2011 (LPLV).|
741925|NCT01071798|Data were recorded throughout Germany in 264 study centers.|
741926|NCT01071538||
741927|NCT01071512||
741928|NCT01071395|Location: Medical clinics|
741929|NCT01071356|Participants were randomized using stratified permuted blocks to ensure balance by gender and meth severity (defined as 10 or more days of meth use in the past month vs. less than 10 days in the past month)|A total of 620 participants were screened for the study over the 36 month period with 563 meeting eligibility. Of the 563, 308 completed baseline assessments and 217 of them were randomized to an MI treatment condition; 91 persons completed a baseline interview but did not show up for randomization.
741930|NCT01071317||
741931|NCT01071278||
741932|NCT01071252||
741933|NCT01071200||
741934|NCT01071096||
741935|NCT01071083|Date of first treatment: 31 March 2010. Date of study completion: 02 November 2011.|175 subjects were enrolled, all 175 were randomized.
741936|NCT01071070|Participants were enrolled in the study at investigative sites in China. Recruitment began in October 2009 and ended in July 2010. The study population consisted of participants with Stage 5 chronic kidney disease who were receiving hemodialysis.|If subjects were receiving vitamin D receptor (VDR) activators, they participated in a Washout Phase for 2 weeks prior to entering into the Screening Phase in order to wash out any VDR activators and their potential hysteresis or carryover effects.
741937|NCT01071044|Study site began recruiting for the trial in Oct 2009 and the last subject completed the final visit on 3/7/11. Recruitment was done from within the Rochester Center (a private mental health practice), as well as some local advertising and community outreach.|
741938|NCT01070979|Enrollment of postmenopausal women for relief of hot flushes and urogenital symptoms beginning Feb '03 at 33 sites in the US.|Discontinue estrogen/hormone therapy prior to enrollment
741939|NCT01070966||
741940|NCT01070953||
741941|NCT01070888|October 2010 to October 2012|excluded from failed run-in or not qualify by exercise challenge
741942|NCT01070810||
741943|NCT01070784|The first participant entered the study on 28 January 2010, and the last participant completed the study on 24 October 2011. A total of 328 participants were enrolled at 60 centres in Japan, and 260 participants who fulfilled the randomisation criteria were randomised.|The study starts with an enrolment visit, Visit 1 prior to any other study-related activity. At Visit 2, the lung function will be measured to assess the eligibility of the patients. Subjects who fulfil all eligibility criteria will begin the 2-week run-in period.During the period, the previous treatment will be continued to record the baseline.
741944|NCT01070771||
741945|NCT01070693|Included were 300 adult patients (282 men, 18 women) referred for elective repair having unilateral or bilateral inguinal hernias. Study period: September 2001 - January 2004, outpatient unit of Jorvi Hospital (Helsinki University Central Hospital, Espoo, Finland).|
741946|NCT01070550|A total of 4680 participants were enrolled into the study conducted from June 2007 to July 2011 at 332 centers in 14 countries.|
741947|NCT01070394|The first 25 participants enrolled consisted of adults who had recently completed a randomized, cross-over, open label study (MAS Adherence Study) that examined adherence to ADHD treatment with MAS IR vs. MAS XR. An additional 15 adults were recruited from local advertising and from the pool of participants at the MHADRP at the NYU SoM.|Participants taking prohibited concomitant medications, including ADHD medications, will be required to washout of their medication during the screening phase.The washout period will be one week for psychostimulants and three weeks for non-stimulants.
741948|NCT01070381||Three participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
741949|NCT01070329||"Double-blind treatment phase: Participants randomly assigned to duloxetine received 30 mg once daily (QD) for 1 week, followed by 60 mg QD for 7 weeks. Participants randomly assigned to placebo received placebo QD for 8 weeks.
~Taper phase: Duloxetine group: 30 mg QD for 2 weeks. Placebo group: QD for 2 weeks."
741950|NCT01070316|23 participants were screened; 3 participants were not eligible to begin treatment and were not enrolled|
742125|NCT01059994|Males in the age groups of 20-35 and 60-80 were recruited. Subjects were screened and enrolled at the University of Texas Medical Branch in the Institute for Translational Sciences Clinical Research Center (ITS-CRC).|Participants who failed screening, did not otherwise meet inclusion criteria, or decided not to participate were excluded before being assigned to intervention groups.
741951|NCT01070303|Participants who were still receiving study drug and were evaluated at Week 56 of Study M02-433 (NCT00055497) are included in the open-label extension (OLE) (NCT01070303). Participants entered NCT00055497 from a lead-in adalimumab induction therapy study (NCT00055523).|"Clinical remission = CDAI <150. At Week 4 of NCT00055497, remitters (participants in clinical remission at Week 0 and Week 4 of NCT00055497) were randomized to double blind (DB) therapy and non-remitters (participants not in clinical remission at Week 0 or no longer in clinical remission at Week 4) were assigned to open-label (OL) adalimumab."
741952|NCT01070173|Fifty-two patients were recruited into the study.|
741953|NCT01070095|Recruitment was carried out across two academic family health teams (primary health care teams including family physicians, nurses, and allied health members) in Hamilton, Ontario and one community-based family health team in Brampton, Ontario. Clinics used the OSCAR electronic medical record (EMR) system and were under a capitated funding model.|Only clinicians/practitioners were enrolled in the trial, but data were collected from patients of the clinicians so they are represented as a separate group. All asthma patients of enrolled clinicians were included in the analysis, but patients seen in the baseline/intervention periods were not necessarily the same and their number thus differs.
741954|NCT01070043||A 4 week run-in phase preceded the randomized, double-blind treatment phase of the study. During the run-in phase, participants took valsartan 80 mg daily before a meal. Sixty participants entered the run-in phase. Those participants who met the inclusion criteria entered the randomized, double-blind treatment phase.
741955|NCT01069939|First participant enrolled on 4 February 2010. On 20 May 2011, the efficacy analysis was completed based on positive results of an interim analysis so that the efficacy data in this report are at the interim analysis. To evaluate the safety, the study was continued. The last participant completed the study on 9 November 2011.|Out of 914 enrolled participants, 430 participants were assigned , but 484 participants were not assigned. The major reasons of no assignment were 'Did not meet eligibility criteria' (462 participants) and 'Voluntary discontinuation by participant' (21 participants). After 366 participants were randomised, the interim analysis was done.
741956|NCT01069900|The study was conducted at multicenter between 21 July 2010 (first subject first visit) to 21 January 2015 (last subject last visit).|Overall 478 subjects were enrolled, 20 subjects had screening failures hence, 458 subjects were randomized to receive treatment.
741957|NCT01069861||
741958|NCT01069627||
741959|NCT01069562|The recruitment of participants started on 10th January 2009 and ended on 24th June 2010. All patients recruited were admitted for elective cardiac surgery in the Cardio Thoracic Surgery ward in Post Graduate Institute of Medical Education and Research, Chandigarh, India.|All the patients who were enrolled were randomized to the two study arms.
741960|NCT01069523|Subjects were recruited from 4/2010 through 6/2011 primarily through flyers in child psychiatry clinics and by informing families who called the clinic intake line.|After diagnostic assessment and confirmation that subjects meet study criteria, subjects were scheduled for a baseline EEG and they performed the Stop Signal Task while ERP data was obtained. 42 subjects completed baseline evaluation,13 did not complete baseline EEG, leaving 29 to be randomized to drug
741961|NCT01069510|Recruited at time of presentation for larger study. However, most did not meet enrollment criteria and could not be randomized.|
741962|NCT01069484|Participant were recruited from a cohort study at Akershus University Hospital (Hilde 2012), or from the hospital's maternity ward or from community health care clinics after giving birth (Hilde 2013).|
741963|NCT01069419|"This non-interventional study started to enroll participants in Germany in October 2009 and concluded in December 2014.
~Participant Flow refers to the Enrolled Set."|There were 13 patients with missing termination information. Therefore only safety data were analyzed for these 13 patients. Patients with missing termination information were neither considered as completer nor as non-completer in the Clinical Study Report. These patients are considered as non-completers in the summary below.
741964|NCT01069354||
741965|NCT01069341|Subjects were recruited from the patients seen in the Ophthalmology Department at the University of Medicine and Dentistry of New Jersey.|
741966|NCT01069315||
741967|NCT01069289|The first participant entered the study on 28 January 2010, and the last participant completed the study on 30 March 2011. A total of 1,710 participants were enrolled at 163 centres in 9 countries in Asia and Europe, and 1,293 participants who fulfilled the randomisation criteria were randomised.|The study started with an enrolment visit, Visit 1, 0 to 4 weeks prior to Visit 2, and 1-2 week run-in period before randomization. At Visit 2 participants had to have pre-bronchodilatory forced expiratory volume in one second (FEV1) less than or equal to 50 percent of the predicted normal value.
741968|NCT01069185||
741969|NCT01069172|Subjects served as their own control. Subjects were to have FS laser surgery in one eye (FS surgery eyes) and CCC with U/S surgery in their fellow eye (CCC surgery eyes). Assignment to one of the two surgery groups (FS or CCC) was randomized.|30 subjects were included in the study, but one subject withdrew prior to surgery on their second eye. Baseline and outcome measure analysis was performed on the 29 subjects with both eyes enrolled. Of these 29 subjects, all had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes).
741970|NCT01069120||
741971|NCT01069003||Enrolled 2272 but only 2262 subjects were analysis receiving the Endeavor stent only.
741972|NCT01068964||
741973|NCT01068912||
741974|NCT01068873||
741975|NCT01068860||Qualified patients entered a 4-week run-in period while taking current therapy thru the study. After the run-in, patients had the baseline meal challenge. Then patients were randomized. A 2nd meal challenge was performed after 4 wks. This ended the study except for a follow up phone call after approx.90 days to record serious adverse events (SAEs)
741976|NCT01068821|Patients with planned laparoscopic or robotic procedures were offered participation in the preoperative holding area. Recruitment started 3/1/2010 and ended 5/10/2010.|Patients were enrolled if they acknowledged their desire to participate. Patients were excluded if they were brought to the operating room before being approached for participation or if they indicated they did not wish to participate. The materials being compared are already both commonly used for gynecologic surgery.
741977|NCT01068769|Participants were enrolled at three sites between February and December, 2010.|
742126|NCT01059929||
741978|NCT01068743|Participants (N = 24) who met all of the inclusion and none of the exclusion criteria were recruited from a single site in the United States.|Participants were screened for eligibility within 21 days before Day 1 of period 1. On Day -1 of each period, the participants were admitted to the clinical facility and confined for 4 days. All the 24 participants were randomly assigned to 1 of 4 treatment sequences (ADBC, BACD, CBDA, or DCAB). The washout between each dose was at least 7 days.
741979|NCT01068730|A total of 28 participants who met all of the inclusion and none of the exclusion criteria were planned and enrolled in the study from a single site in the United States.|Participants were screened for eligibility within 21 days before Day 1 of period 1. On Day -1 of each period, the participants were admitted to the clinical facility and confined for 4 days. All the 28 participants were randomly assigned to 1 of 4 treatment sequences (ADBC, BACD, CBDA, or DCAB). The washout between each dose was at least 7 days.
741980|NCT01068717||A total of 27 participants were enrolled and randomly assigned to 1 of 4 treatment sequences: ADBC, BACD, CBDA, or DCAB. One participant withdrew from the study on Day -1 of Period 2 due to a family emergency and returned for early termination assessments on Day 4 of Period 2. She did not receive study drug in Period 2.
741981|NCT01068678|The trial was conducted at 94 sites in 7 countries: Canada (14 sites), Czech Republic (5 sites), Israel (5 sites), Slovakia (5 sites), South Africa (3 sites), United Kingdom (8 sites) and United States (54 sites). In addition, 9 sites (United Kingdom (1 site) and United States (8 sites)) were approved, but did not enroll any subjects.|
741982|NCT01068665|The trial was conducted at 106 sites in 8 countries: Canada (11), France (6), Ireland (3), Russian Federation (7), South Africa (4), Ukraine (2), United Kingdom (18) and United States of America (55).|Subjects continued on metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitors at the pre-randomisation dose level and dosing frequency.
741983|NCT01068652|The trial was conducted at 23 sites in 4 countries: Egypt (1), Algeria (9), Tunisia (4) and South Africa (9). The trial consisted of two weeks of screening, three weeks of run-in, and 50 weeks of treatment.|
741984|NCT01068626|From May 2006 to July 2007 a total of 78 subjects were screened at the Sahlgrenska Hospital. Among these, 59 fulfilled all inclusion and no exclusion criteria and were randomized to treatment. During follow-up 5 patients (7 %) withdrew from the study, resulting in 54 patients who completed the study, comprising 27 patients in each study group.|Among patients that were screened 19 patients did not fulfill inclusion criteria or displayed exclusion criteria and did not enter the study.
741985|NCT01068600||
741986|NCT01068548||
741987|NCT01068509||
741988|NCT01068418||
741989|NCT01068262||
741990|NCT01068158|Participants were enrolled and treated from 4 March 2010 to 17 June 2010 in 8 US clinical centers.|A total of 371 participants who met the inclusion and exclusion criteria were enrolled and treated.
741991|NCT01067976|Recruitment period: 19 Feb 2010 - 08 Jul 2011.|
741992|NCT01067846|Recruitment included outpatient and inpatient alcohol and drug abuse clinics, self-referrals, flyers in public places, and advertisements in newspapers. Recruitment started June 2010 and ended September 2011.|Enrolled participants could have been excluded due to other drug dependencies, loss of consciousness > 10 min, neurologic disorder, severe hepatic insufficiency, significant cardiovascular disease, current psychiatric disorder, current medical illness, sensory impairment, positive pregnancy test.
741993|NCT01067781||
741994|NCT01067768|Adult patients hospitalized with indwelling urinary catheters at a tertiary care, 300-bed, teaching hospital in Colombia- South America, were recruitment between November 2009 and May 2010.|1.325 patients were assessed for eligibility. 143 were excluded (98 urinary infection and 45 spinal cord injury).
741995|NCT01067716|One or both eyes of 79 subjects (150 eyes) were treated.|
741996|NCT01067521|A total of 1524 subjects were screened in this study, and 120 (7.9%) subjects failed screening. Of these, 69 did not meet inclusion or exclusion criteria, 30 withdrew from the study and 21 failed screening for other reasons.|1404 subjects were enrolled and randomized in the placebo-controlled (PC) double-blind period. Participants were randomized 2:1 to the treatment arms.
741997|NCT01067508|Subjects will be recruited by posting flyers around the UCLA campus community. Initial eligibility will be determined by a telephone conversation in which the study procedures and inclusion/exclusion criteria are reviewed.|
741998|NCT01067469|Recruitment Period: January 2010 to January 2015. All recruitment done The University of Texas MD Anderson Cancer Center.|Of the 83 participants enrolled 12 were screen failures and therefore never assigned to treatment arms.
741999|NCT01067456|Emergency Department, 9-month enrollment period starting January 2008|
742000|NCT01067352|Participants were recruited in 12 study centers in Italy from 20 Feb 2004 to 10 Jul 2009.|
742001|NCT01067339|Subjects were recruited at the Mayo Clinic in Rochester, Minnesota between February 2010 and February 2015.|70 subjects signed informed consent, but 5 subjects withdrew (subject decision) prior to randomization.
742002|NCT01067326|Subjects were recruited from the Division of Cardiology at the Mayo Clinic in Rochester, Minnesota. 22 subjects were randomized to the study, 2 subjects were affected by the early study termination and thus have no follow-up data.|
742003|NCT01067144||1805 patients were assessed for eligibility; 422 were enrolled and randomized.
742004|NCT01067105||
742005|NCT01066936|This study was conducted by 1 investigator in 1 country from 14 Sep 2009 to 18 Apr 2016.|A total of 22 subjects were screened, with 20 subjects enrolled and had surgery/MIS implanted.
742006|NCT01066923||Active Cooling Arm not completed - insufficient number of subjects were recruited to complete these arms of the trial, and the Passive Cooling arms were the only ones conducted.
742007|NCT01066897||
742008|NCT01066871||
742009|NCT01066819|A total of 1656 participants were enrolled in this study conducted from January 2008 to August 2011 at 111 centres in United States.|
742010|NCT01066793|A total of 2343 participants were enrolled in this study conducted from October 2007 to May 2011 at 125 centers in Belgium, Italy, United Kingdom, and Ireland.|
742011|NCT01066780||All subjects were fit acutely at the Baseline Visit (Visit 1) with ClearVoice Low and underwent acute speech perception testing. Each subject was then randomized to Group A or Group B.
742012|NCT01066637||
742013|NCT01066624||
742171|NCT01057693||
742172|NCT01057589||
742016|NCT01066520|Initiation date stage I(299 patients):24.08.2009, completion date stage I: 19.01.2011 Initiation date stage II(150 patients): 04.03.2011, completion date stage II: 12.09.2011 The evaluation criteria have not been changed in the different stages. The interim analysis after Stage I re-confirmed the originally calculated sample size.|Athletes of both sexes with acute unilateral sprain of the lateral ankle joint; 18 to 40 years of age; injury occurred within 24 hours of the first dose of study medication, with moderate (30-60mm) to severe (>60mm) pain on weight bearing.420 of the enrolled 449 patients have been selected into the ITT population. 447 patients received treatment
742017|NCT01066364||
742018|NCT01066156||
742019|NCT01066143||8 subjects participated in screening but later were found to be ineligible for study participation
742020|NCT01066104||
742021|NCT01066052||
742022|NCT01066039||
742023|NCT01066026||
742024|NCT01066000|The study was conducted at 10 sites in the Indonesia and the study period was from 05 October 2009 to 12 September 2011.|Of the 85 screened participants 52 were screening failure due to abnormal haemoglobin concentration and 33 were enrolled in the study.
742025|NCT01065844||
742026|NCT01065818||
742027|NCT01065779||
742028|NCT01065766|In this post-marketing surveillance study of sitagliptin/metformin (JANUMET®), participants in South Korea treated for >= 24 weeks were evaluated for long-term safety and efficacy. During the re-examination study period (December 4, 2005 to September 20, 2013), case report forms (CRFs) were collected from 4,065 participants.|
742029|NCT01065714|Recruitment from March 2010 through September 2010. Subjects enrolled from physician data base.|
742030|NCT01065597||
742031|NCT01065571||
742032|NCT01065558|Patients were recruited by the investigators according to the inclusion and exclusion criteria|No preassignment
742033|NCT01065506||Of the 150 enrolled participants, 7 participants completed a baseline assessment, then subsequently dropped out of the study before receiving any treatment. 7 participants were used as pilots. Accordingly, results are reported for the remaining 136 participants.
742034|NCT01065480||
742035|NCT01065454|Only subjects with symptomatic pulmonary hypertension associated with left ventricular systolic dysfunction (PH-sLVD) could participate in this study. Subjects must have been pre-treated with optimized CHF therapy.|301 subjects were screened in 84 study centers in 18 countries worldwide. 99 of the 301 screened subjects were not randomized (adverse event [1], protocol violation [1], screen failure [87], withdrawal by subject [10]). Of the 202 subjects randomized, one subject did not receive any study medication.
742036|NCT01065428|In a 20 beds general ICU of a teaching hospital, from December 2008 to May 2010, 52 patients , mechanically ventilated for > 24 h, were included when they deemed ready for extubation by the clinical team and fulfilled established weaning criteria.|Nasogastric tube Eligible patient was replaced with a modified EAdi catheter (Maquet, Solna, Sweden). Then the patients were switched to a Servo-i ventilator capable of processing signals of EAdi automatically.
742037|NCT01065350|Patients requiring surgical procedures with general anesthesia were recruited and enrolled at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire from December 2010 to March 2011.|
742038|NCT01065051|Only subjects symptomatic with pulmonary hypertension associated with left ventricular systolic dysfunction (PH-sLVD) could participate in this study.|One subject was screened, randomized and treated during this study. The subject completed the study according to protocol.
742039|NCT01064947|Subjects with suspected secondarily infected atopic dermatitis were recruited from the investigator's medical practice. Recruitment occurred from July 2010 through November 2011|Seventy subjects were enrolled into the study. Of these 29 had a positive culture for s. aureus (MRSA and MSSA) or S. pyogenes
742040|NCT01064882||
742041|NCT01064856||
742042|NCT01064830||
742043|NCT01064817||
742044|NCT01064739|Participants were recruited in the Nashville, TN area between November, 2009 and November, 2010.|
742045|NCT01064713|Recruitment period: August 9, 2010 to July 12, 2012. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.|No participants were enrolled in Stage 2 of the study.
742046|NCT01064687||Due to ethical considerations and to preserve the blinding of the study, participants randomized to placebo at baseline were reassigned at 26 weeks to either 1.5 mg LY2189265 or 0.75 mg LY2189265 from 26 weeks through 52 weeks.
742047|NCT01064648|117 participants were enrolled, only 112 participants were included in the analysis: 5 patients were either not eligible or not analyzable. Thus these 5 patients were excluded from any analysis.|
742048|NCT01064622||Prior to the phase II randomized trial, an open-label, lead-in phase I study was conducted with all patients receiving gemcitabine hydrochloride plus vismodegib. Seven patients were enrolled and no safety issues were identified.
742049|NCT01064531|Subjects were enrolled by 1 investigator in Canada. The study period was from 30 Jun 2009 to 22 Apr 2016.|Preoperative evaluation was conducted following signing of the ICF but prior to randomization. A total of 41 subjects had surgery for either MIS Stem or Synergy implantation.
742050|NCT01064414|This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus and moderate renal impairment. The study was conducted between 02 March 2010 and 19 January 2012 and recruited patients from 89 study centers located in 19 countries worldwide.|"272 patients were randomly allocated to the 3 treatment arms. 269 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented in two parts: for Baseline to Week 26 as Core Period, and for Week 26 to Week 52 as Extension Period."
742051|NCT01064401||
742052|NCT01064362||
742053|NCT01064323||
742054|NCT01064310|There were169 participants randomized and one participant randomized in error with no data available|
742055|NCT01064297||
742056|NCT01064284|303 boys were assessed for eligibility, 39 were excluded, therefore, of those 303, only 264 patients underwent randomization. Of these 264, only 251 were analyzed.|
742173|NCT01057433||
742174|NCT01057394||The Sponsor stopped the study for business reasons before any participants were enrolled in the RF arm.
742175|NCT01057277||
742057|NCT01064167|From February 2009 to December 2009, 378 consecutive patients in Fuwai hospital scheduled for elective OPCAB were enrolled in the study. 118 patients were excluded for randomizatin because not meeting inclusion criteria(n=29), Refused to participate(n=81),and surgery cancelled(n=8).|Of the 260 patients randomized, 130 were allocated to each group. 14 patients in tranexamic acid group and 15 in placebo group were withdrawn from the study for convert to on-pump surgery in course of surgery.
742058|NCT01064076|A total of 33 investigational sites participated in the study, twenty-eight (28) of which were in the United States, 2 in New Zealand, 2 in The Netherlands and 1 in the United Kingdom. A total of 330 patients were enrolled between January 27, 2010 and May 20, 2011.|Of the 330 enrollments, 321 underwent an implant procedure (implant attempt) and 9 were withdrawn prior to the commencement of the implant procedure.
742059|NCT01063972||
742060|NCT01063907|Study centers in the USA and the UK participated in the Phase 1 portion, and study centers in the USA, UK, and Philippines participated in the Phase 2 portion.|
742061|NCT01063881|A total of 285 patients were enrolled in the study, of which 281 patients received at least 1 dose of study drug were included in the safety analysis set (Dapoxetine 30 mg only [144 patients], Dapoxetine 30 t0 60 mg [124 patients] and Dapoxetine 30 to 60 to 30 mg [13 patients]).|
742062|NCT01063868||
742063|NCT01063855|Study R096769-PRE-3008 was conducted at 69 study centers in 13 countries between 27 April 2010 and 31 August 2011.|Of the 495 randomized patients, 429 patients completed the study, and 66 patients were discontinued from the study. All randomized patients (N=495) were included in the intent-to-treat analysis set of patients for efficacy and safety.
742064|NCT01063829||133 patients were randomized to the trial; 2 randomized patients did not receive the assigned study drug ( 1 Patient died and 1 Patient had CMV reactivation before intended administartion of first dose)
742065|NCT01063764|Full Analysis Set (FAS) includes all subjects taking at least one dose of study medication. Per-Protocol Set (PPS) is a subset of the FAS, consisting of subjects without major protocol violations affecting the primary efficacy variable.|Participant Flow refers to the Full Analysis Set. First Period started after Baseline (Week 0 to Week 8).
742066|NCT01063712|"Prospective clinical study between June 2009 and December 2010 in La Paz, Bolivia. 29 out of 59 patients selected with inclusion and exclusion criteria(≥ 10 Kg, Patient Arterial Duct of 2 - 8 mm minimal diameter, Nit-Occlud® PDA-R used, systolic pulmonary pressure ≤ 67% of systolic aortic pressure and absence of any other chronic disease)."|30 patients were excluded. Four and eight patients with Patent Arterial Duct bigger than 8 mm or smaller than 2 mm, eleven patients with pulmonary pressure elevated more than 67% of systolic pressure, nine patients lighter than 10 Kg and three patients with atypical ducts. Some were excluded for more than one reason.
742067|NCT01063595||
742068|NCT01063517|This study was conducted at 13 sites in South Korea. Enrolment started in February 2010 and was completed in May 2012. In total 124 patients were randomised in the study (62 in the olaparib+paclitaxel arm and 62 in the placebo+paclitaxel arm).|Patients of either sex, age more than 17 years with recurrent or metastatic gastric cancer that had progressed following first line therapy, a confirmed Ataxia Telangiectasia Mutation (ATM) status, Eastern Co operative Oncology Group (ECOG) performance status ≤2, normal organ and bone marrow function, and life expectancy ≥16 weeks.
742069|NCT01063348||
742070|NCT01063283||All enrolled patients received one cycle and those who tolerated it and had no evidence of risk for dose escalation were randomized to receive one of two treatment regimens.
742071|NCT01063153||
742072|NCT01063075||Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and carboplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants were placed into Group D arm only.
742073|NCT01063062|107 participants were enrolled from 11 centers in Egypt, 2 centers were prematurely terminated.|Patients in this 1 arm tocilizumab study were divided into 2 groups: tocilizumab monotherapy or tocilizumab plus methotrexate (patients taking disease-modifying antirheumatic drugs at Baseline who continued concomitant treatment with methotrexate as per standard of care at the investigator's discretion).
742074|NCT01063049|Subjects had their colonoscopy performed between February 2010 and February 2011 by one of three gastroenterologists (DG, JH, and MR) with 17 to 34 years of experience. Colonoscopies were scheduled to begin between 0800 h and noon in the gastrointestinal labs at our office or two community hospitals.|
742075|NCT01063036|Study initiated 17 May 2010; Week 48 Primary Endpoint 27 November 2012; Week 96 Study Completed18 February 2014. Participants with chronic Hepatitis B with surface antigen (HBsAg) who have been currently treated and experienced treatment failure were enrolled.|144 enrolled; 92 treated. Reasons for 52 never treated: physical/laboratory test findings 30; not in target population 21; no signed consent 7; medical history/concurrent disease 2; other exclusion criteria 1; unknown 3.
742076|NCT01062971||
742077|NCT01062893||
742078|NCT01062841|Residents with an indwelling urinary catheter and/or feeding tube were recruited from 12 nursing homes, May 2010 - April 2013|
742079|NCT01062763|Patients recruited from outpatient clinics of endocrinology at two university hospitals and two general hospitals in the period from May 2010 to March 2012.|163 patints screened. 44 screenfailures due to exclusion criteria as indicated. 119 randomized
742080|NCT01062568||
742081|NCT01062555||All patients consented at time of transplant for phase 1. At 6 months post-transplant, patients were re-consented for phase 2. All patients represented for phase 2 were included for phase 1. Patients who were not re-consented for phase 2, were followed for 7 years under phase 1 protocol.
742082|NCT01062425||After patient registration, sites submitted tissue for central histology and methyltransferase (MGMT) gene methylation evaluation. If tissue was evaluable and a patient continued on study, then treatment arm was assigned. Two hundred sixty-one patients were registered, 103 did not continue to treatment assignment, 158 had treatment assigned.
742083|NCT01062399||A total of 279 patients registered at 1st registration for central pathology review of histology confirmation. Among 279 patients, 72 patients did not go beyond 2nd step registration due to insufficient tissue, patient refusal, progression of disease, and other reasons.
742084|NCT01062308|Date of first Recruitment: Sep.2009 Date of Completion: March 2012|
742176|NCT01057251|Recruitment occured from March 2010 through October 2010 at 36 US sites.|A 4 week single-blind placebo washout phase was required for patients on anti-hypertensives at screening.
742085|NCT01062269|Recruitment started in January 2010 and ended in February 2010. Enrollment officially closed on February 25th, 2010. All patient screening and study visits were conducted at L-MARC Research Center's clinic.|Enrolled subjects were required to meet all of the inclusion and none of the exclusion criteria prior to being randomized to a group assignment. Subjects were also required to undergo vital sign obtainment, a brief physical exam, and a medical history review to ensure they were generally healthy.
742086|NCT01062256||Participants stratified by gender and time of dosing (before or at 3:00 pm versus after 3:00 pm).
742087|NCT01062230||
742088|NCT01062165|Volunteers recruited with fliers at medical center.|
742089|NCT01062126||
742090|NCT01062113||
742091|NCT01062074||
742092|NCT01062061||
742093|NCT01062009||One patient was enrolled but withdrawn by PI due to insufficient intravenous access to obtain study labs
742094|NCT01061866|Patients with refractory epilepsy, 25 years old mean, with antiepileptic treatment and several seizures by month and male gender and they were recruited by Epilepsy Clinic|Males without seizures three months prior to thalidomide administration and patients without electroencephalographic study and without antiepileptic treatment.
742095|NCT01061775||
742096|NCT01061736|The study was conducted at 247 centers in 36 countries. Overall, 3715 participants were screened between March 2010 and July 2012, 2040 of whom were screen failures. Screen failures were mainly due to failure to meet the inclusion criterion for severity of the disease and/or due to meeting the exclusion criterion.|Randomization was performed centrally with allocation generated by Interactive Voice/Web Response System, stratified by geographical region and prior biological use. 306 participants were randomized in Part A. 1369 participants were randomized in part B, 172 before dose selection (cohort 1) and 1197 after dose selection (cohort 2).
742097|NCT01061723|The study was conducted at 68 centers in Europe, Canada and the United States. A total of 563 participants were screened between 04 February 2010 and 24 February 2011. Of 563 participants, 301 were randomized and 300 were treated.|Participants were randomized in 1:1:1:1:1:1 ratio for Placebo and Sarilumab (100 mg weekly [qw]; 150 mg qw; 100 mg every other week [q2w]; 150 mg q2w and 200 mg q2w) with screening high-sensitivity C-Reactive Protein (hs-CRP) (≤1.5 mg/L or >1.5 mg/L) and region as stratification factors.
742098|NCT01061710||This survey enrolled those who participated in preceding varenicline Drug Use Investigation protocol A3051109 (NCT00772941) and retreated with varenicline within 52 weeks of initial treatment.
742099|NCT01061671||
742100|NCT01061606|A total of 8 patients were enrolled at two institutions between July 2010 and January 2012|
742101|NCT01061567||
742102|NCT01061528||
742103|NCT01061476|The study was conducted between 2010 and 2011. Patients were primarily recruited from the JH Sleep Disorders Center with a NREM RDI >= 10/h and >=90% of events were considered obstructive. 17 subjects met eligibility criteria with 12 enrolled.|Subjects were brought in for an evaluation prior to study enrollment to see if they would tolerate the Provent device by lying down with the device in place for 15-20 minutes.
742104|NCT01061385||
742105|NCT01061359||A total of 1982 participants were enrolled, however, during database lock, 10 participants were identified as duplicates. Therefore, a total of 1972 unique participants were identified for the study.
742106|NCT01061333||
742107|NCT01061177||ITT: intent to treat; b3a2 & b2a2 +ve are categories of BCR-ABL transcripts (BCR-ABL1 is an abnormal gene found in chronic myeloid leukemia and acute lymphoblastic leukemia patients; CyR (Ph+ Patients Only) = cytogenic response for Philadelphia positive patients only.
742108|NCT01061151||
742109|NCT01061034|healthy volunteers were recruted on march 2007. all of the patients are co-workers in the department of medicine in assaf harofeh medical center.|one volunteer was excluded before enrollment due to recent consumption of NSAIDS
742110|NCT01061008|Patients with stage four and five CKD attending two renal units in North Wales, UK were invited to participate in the study.|
742111|NCT01060670|Participants were recruited based on physician referral at 36 medical centers between March 2010 and November 2013. The first study participant was enrolled in April 2010 and the last study participant was enrolled in November 2013.|Participants participated in a Run-In phase that must last a minimum of 14 days, but may have been extended up to 17 days to allow for scheduling of the randomization visit.
742112|NCT01060592|35 pts recruited between Oct 2009 and Jan 2010|N/A - Single arm non-randomized study
742113|NCT01060553||34 subjects were interviewed for consent. 15 were assigned to immediate treatment. 15 were assigned to wait list treatment. 2 did not meet inclusion criteria. 2 were assigned to case study.
742114|NCT01060540||
742115|NCT01060384|All the patients will receive 8 weekly infusions of Ofatumumab 1000mg. Dose escalation of Lenalidomide planned in three dose cohorts. Dose reduction Cohort (-1) will be added if severe adverse events noted in 2/3 patients. Phase II will evaluate Lenalidomide at maximum tolerated dose (MTD) and Ofatumumab in 36 patients.|
742116|NCT01060345||
742117|NCT01060150||
742118|NCT01060124||
742119|NCT01060111||Out of 250 consented participants, 243 participants were assigned to study treatment.
742120|NCT01060098||
742121|NCT01060072|This study was conducted at 22 enrolling sites; 2 in the European Union (EU) and 20 in the United States (US). First participant was enrolled on 2/19/2010 and last participant completed the study on 9/3/2010.|A total of 407 participants, who were candidates for routine, uncomplicated cataract surgery, were enrolled in the study, 400 participants completed the study.
742122|NCT01060059||Six patients were not assigned to any cohort because the type of treatment taken was not reported.
742123|NCT01060020||Participants stratified according to ejection fraction and randomized to either Sildenafil 40mg and 80mg Groups were combined into a single Arm/Group for analysis as pre-specified in the study protocol.
742124|NCT01060007|The study opened to participant enrollment on 11/10/2009 and closed to participant enrollment on 04/18/2012.|
742177|NCT01057225||
742178|NCT01057121||
742179|NCT01057017|5 Patients were enrolled at The Miriam and Rhode Island Hospital|
742180|NCT01056913||
742181|NCT01056822||
742127|NCT01059903|A total of 50 healthy, male subjects have been randomized in order to complete the trial with at least 38 subjects qualified for the Pharmacokinetic Set (PKS). Baseline characteristics refer to the PKS which is the primary analysis set.|Eight subjects that fulfilled predefined criteria for patch adhesiveness were excluded from the statistical analysis on the PKS. The predefined criteria were patch adhesiveness smaller than 75% at any timepoint or an adhesiveness lower than 90% for 12 hours or more.
742128|NCT01059877||
742129|NCT01059864||
742130|NCT01059851||16 participants were enrolled in Part I of the study. Because the primary hypothesis was met in Part I, no participants were enrolled in Part II of the study.
742131|NCT01059825||Of the 375 enrolled participants included in the metformin run-in period, 328 participants were randomized to 1 of 6 treatment groups.
742132|NCT01059812|The trial was conducted at 45 sites in 5 countries: Japan (16 sites), South Korea (16 sites), Hong Kong (1 site), Malaysia (8 sites) and Taiwan (4 sites).|
742133|NCT01059799|The trial was conducted at 52 sites in 6 countries: Hong Kong (1), Japan (12), Malaysia (8), South Korea (19), Thailand (6) and Taiwan (6)|Subjects continued on their current treatment with oral antidiabetic drug(s) (OAD(s) treatment except for dipeptyl peptidase-4 (DPP-4) inhibitors, at the pre-randomisation dose level and dosing frequency.
742134|NCT01059773||One patient received on-study methotrexate only but no ustekinumab and was therefore excluded from the analysis.
742135|NCT01059760||
742136|NCT01059682||
742137|NCT01059643||All participants who received at least one dose of study drug in both Cycle 1 and Cycle 2 or to have progressed or died on or before study Day 42 were considered to be completed.
742138|NCT01059630||
742139|NCT01059617||
742140|NCT01059565|Participants were enrolled at 34 sites in the United States and 1 site in Canada. The first participant was screened on 22 February 2010. The last participant observation was on 28 December 2010.|102 participants were screened and 101 were randomized. Of those participants randomized, 100 received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
742141|NCT01059539||
742142|NCT01059526|Patients indicated in the US FDA-approved product label for KALBITOR (ecallantide) who experienced an acute attack of HAE were eligible for inclusion in this trial.|Subjects were to complete screening/enrollment procedures on a separate day prior to receiving KALBITOR treatment for an acute attack of HAE. The primary and secondary endpoints were analyzed for the Safety population only (all patients who received at least 1 treatment dose of KALBITOR).
742143|NCT01059435|This was a single-center study conducted in the USA. The first participant enrolled on 13 December 2006 and the last participant completed the study on 06 July 2007.|Participants were enrolled sequentially into 1 of 6 dose cohorts. Healthy postmenopausal women were randomized to romosozumab or placebo in a 3:1 ratio at 0.1, 0.3, 1 mg/kg SC, 1 mg/kg IV, 3, 5 mg/kg SC, 10 mg/kg SC, or 10 mg/kg IV; healthy men received romosozumab SC or IV, placebo SC or IV in a 3:3:1:1 ratio at doses of 1 mg/kg or 10 mg/kg.
742144|NCT01059357||
742145|NCT01059344|November 2009 - February 2011|Screen failures, not complying to inclusion and exclusion criteria
742146|NCT01059318||
742147|NCT01059305|Recruitment Process: February 15, 2011 to September 11, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.|
742148|NCT01059175||
742149|NCT01059071||
742150|NCT01058993|Subjects were contacted from the Severe Chronic Neutropenia International Registry office by Audrey Anna Bolyard, Manager of the Registry.|Prior to assignment, we performed physician, EKG (electrocardiogram) and screening labs, including CBC (complete blood count), Differential and smear, comprehensive metabolic panel, urinalysis, and pregnancy testing on females subjects
742151|NCT01058941||
742152|NCT01058863||A total of 163 patients were screened and 72 patients were randomized. Most screening failures did not qualify for the study based on reversibility or spirometry criteria.
742153|NCT01058707|Participants took part in the study at 15 investigative sites in Spain and the United States from 4 January 2010 to 7 February 2019.|Participants with a diagnosis of advanced malignancies were enrolled and received rising doses of MLN0128 in the Dose Escalation Phase to determine Maximum Tolerated Dose (MTD). In the Dose Expansion Phase participants were enrolled to receive one of 3 dose regimens: MLN0128 5 mg once daily (QD), 30 mg once weekly (QW) or 40 mg QW.
742154|NCT01058668||
742155|NCT01058655|Patients enrolled from February 2010 through June 2011.|
742156|NCT01058642||
742157|NCT01058421||Deceased subjects were removed from starting period subject numbers for subsequent outcome periods in each cohort. All non-deceased subjects were included in period outcomes analysis and categorized as death in subsequent period, lost to follow-up, remained in hospital or other facility.
742158|NCT01058395||
742159|NCT01058369||
742160|NCT01058356|From September 2008 to November 2009, medical clinic|Patients who begin receiving antibiotics prior to 48 hours before enrollment in this study
742161|NCT01058304||
742162|NCT01058265||
742163|NCT01058239||
742164|NCT01058096||11 participants from 1 investigational site are not included in the analyses due to Good Clinical Practice (GCP) violations.
742165|NCT01058070||
742166|NCT01058005||
742167|NCT01057901||
742168|NCT01057888|From the managed care plan's dataset of practices, we selected all primary care practices that served >30 adolescents covered by the managed care plan in December 2009. The target population was all adolescents ages 10.5 through 17 years enrolled in Monroe Plan on December 31st 2009 with a primary care provider in a participating practice.|One individual was assessed for randomization, was found to have a previous case of anaphylaxis and was not randomized.
742169|NCT01057862|Enrollment was dependent on referrals from several gambling related clinics in the state of CT and unfortunately there were very few referrals causing the study to end with much lower numbers of study subjects than anticipated.|
742170|NCT01057810||837 participants enrolled; 602 randomized; 598 treated. Of the 235 not randomized, 189 no longer met criteria, 28 withdrew consent, 2 suffered Adverse Events, 2 were non-compliant, 1 was lost to follow-up, and 13 were removed for other/unspecified reasons. Post-randomization, 4 no longer met criteria and were not treated (3 placebo, 1 ipilimumab)
742182|NCT01056718|Recruited from the outpatient office at Mercy St. Louis between January 2010 and August 2012. The inclusion criteria were new or established hypertension as defined by serial BP measurements greater than or equal to 140/90 and evidence of left ventricular (LV) diastolic dysfunction as defined by a routine Doppler within a year of enrollment.|
742183|NCT01056653|Participants were recruited from two Canadian cities between December 2008 and June 2011. There were 1035 fathers that were contacted during birth admission (102 enrolled), from another study (7 enrolled), or from a neonatal database (4 enrolled).|Potential participants were screened and enlisted at the time of the infant's birth. When the infant was 2.5 months old, additional screening was done and verbal consent secured.
742184|NCT01056640|Recruitment began on 11/21/09 and completed on 08/07/10. Interested subjects who passed a phone prescreen were seen at the study center or in their homes for consenting and additional study procedures to determine eligibility.|If study subjects consented to be in study and were found to be eligible, they were randomized to be in study. If they were randomized to receive the telemonitor, within 3-5 days the study team make arrangements to go to their home to install the telemonitor.
742185|NCT01056601||
742186|NCT01056536|Study participants were recruited between January 2006 and December 2008.The study was proposed by the administrative staff in the waiting room of the travel clinic.|The study was proposed to 5148 eligible travelers. 1681 travelers accepted to complete the pre-travel questionnaire. 1115 travelers completed the post-travel questionnaire.
742187|NCT01056523|Patients were enrolled in this dose escalation study according to a 3+3 design. Patients not completing 28 days of therapy were replaced as they were not evaluable for the pharmacokinetic endpoint of steady state level of ribavirin.|
742188|NCT01056510||Screening examination was performed within 28 days before randomization. Participants who fulfilled all the inclusion and none of the exclusion criteria were randomized to one of the two treatment groups.
742189|NCT01056484||In the initial 26 weeks [Period 1], this was a randomized controlled trial. After the 26 week assessment, control participants were eligible to receive the meditation intervention, however, some elected not to receive the intervention [non-randomized trial]; all study participants were followed up for additional 26 weeks [Period 2].
742190|NCT01056380|Patients were enrolled at 11 primary care health centers throughout the United States in the last months of the 2009/2010 flu season|
742191|NCT01056341||"512 patients were included in the study (informed Consent Form signed). Among these 510 patients, 460 were randomized and 52 were screen failure
~At least one inclusion criterion not met in 26 cases
~Parent's decision in 12 cases
~Other reasons in 15 cases.
~One patient was not included for two reasons (Parent's decision and other reason)"
742192|NCT01056328||
742193|NCT01056315||503 participants were excluded from the trial before assignment to a treatment group because they did not meet the inclusion and or exclusion criteria.
742194|NCT01056302||
742195|NCT01056289||Eligible participants entered a 24 Week Open-label treatment phase; participants who completed the Open-label phase were randomized to a 4 Week Double-blind treatment phase.
742196|NCT01056276|Between May 2010 and May 2014, 59 patients with transplant-ineligible Multiple Myeloma (MM) were enrolled at 9 investigational sites in the U.S. The original treatment plan was modified during the trial to decrease intensity but increase treatment duration. Of 59 enrolled patients, 18 were treated on the initial regimen; 41 on the modified plan.|
742197|NCT01056263||
742198|NCT01056198|4/1/2010 to 8/2/2011 at 7 clinics in the U.S.|
742199|NCT01056107|Subjects were recruited at the Mayo Clinic in Rochester, Minnesota.|52 subjects were enrolled, but 6 subjects were excluded because they did not meet eligibility criteria.
742200|NCT01056016||
742201|NCT01055886||110 participants signed consent. 41 were excluded: 25 didn't have current PTSD, 7 had contraindicated other psychiatric disorder, 6 didn't meet smoking criteria, 1 was not willing to quit smoking, 1 didn't want to participate after signing consent, and 1 left before completing screen. Another 4 were lost to contact or w/d before randomization.
742202|NCT01055834||
742203|NCT01055782||
742204|NCT01055769|Participants were enrolled at a single site in China.|
742205|NCT01055704|Study participants included males and non-pregnant, non-breastfeeding females aged 18 to 55 years. All subjects had a minimum body mass index (BMI) of 22 kg/m2.|Subjects were screened for eligibility within 28 days of Day 1 of the study. They were stratified based on gender and BMI (<25, ≥25 kg/m2) and randomized into one of four treatment groups: Treatment groups were randomly assigned in fixed block sizes according to a schedule provided by the study statistician (ARZ). Allocation sequence was concealed
742206|NCT01055639||
742207|NCT01055613||A total of 312 subjects were enrolled in this study. Of the enrolled subjects 12 did not meet the eligibility criteria and 300 were randomized to treatment using an allocation of 2:1 for test and control, respectively. Of the 300 randomized subjects 13 were discontinued from the study and 287 subjects completed the study.
742208|NCT01055496||Screening included CD-20 & CD-22 immunophenotyping of NHL, international prognostic index or follicular lymphoma international prognostic index score, B-symptom and lymphoma evaluation, Eastern Cooperative Oncology Group performance status, left ventricular ejection fraction assessment, computed tomography scans, bone marrow aspirate and/or biopsy.
742209|NCT01055457|A total of 315 subjects were enrolled in this study. Of the enrolled subjects 20 did not meet the eligibility criteria and 295 subjects were randomized to treatment.Of the randomized subjects 16 were discontinued from the study, while 279 completed the study.|Allocation of subjects to the 5 contact lenses was fairly balanced ranging from 57 to 61 subjects per lens, while the allocation of subjects to solution was 2:1 for the test and control solution respectively.
742210|NCT01055314||The number of participants started is 175. Eight patients were declared ineligible by the study chair, and one patient didn't receive treatment.
742211|NCT01055262||
742212|NCT01055223||
742213|NCT01055197||
742214|NCT01055184|Potential subjects were recruited from 3/24/2010 to 11/17/2010. Potential subjects were seen at the Vaccine research Unit clinic.|Only subjects who did not meet inclusion/exclusion criteria were excluded from participation.
742215|NCT01055171||Participants were considered enrolled if they completed both the retrieval and testing procedure (44).
742216|NCT01055132||One subject failed screening, and did not enter group assignment
742217|NCT01055067|A total of 27 participants who met all inclusion and no exclusion criteria were enrolled and treated at 7 clinic sites in the United States, 2 in France, and 2 in the United Kingdom. Of the 27 enrolled, 21 were included in Stage 1 in which the interim futility analysis was performed per the Simon 2-stage design.|Based on the Simon 2-stage design, 21 participants were enrolled (Stage 1). If <2 had either a complete response (CR) or partial response (PR), then the study was terminated. If ≥2 had either CR or PR, then enrollment was extended to 41 participants. After Stage 2 with 41 participants, treatment was effective if ≥5 had CR or PR after 4 cycles.
742218|NCT01055028||
742219|NCT01054976|Of the total of 99 enrolled patients, only 92 were screened.|
742220|NCT01054911||
742221|NCT01054885||Eligible participants (par.) completed a 2-week single-blind (placebo) Run-in Period (RIP) to assess Baseline rescue use, symptoms, disease stability. Par. were then randomized to a 24-week Treatment Period. A total of 1909 par. were screened, 1577 entered the RIP, of whom 1226 were randomized, 1224 received at least one dose of study medication.
742222|NCT01054846|609 participants were enrolled in the study and 2 were later known that they did not meet study inclusion criteria.|Although 285 received Helmet Education only, 68 participants had prior helmet ownership and therefore were considered for further analysis.
742223|NCT01054820||
742224|NCT01054742||Two participants who had relapsed at Follow-up Week 24 of study Part 1, and were enrolled in Part 2 to complete 48 weeks of retreatment.
742225|NCT01054729|Subjects were enrolled at a total of 7 study sites in the United States. The first participant was screened on 18 January 2010. The last participant observation was on 25 August 2011.|143 participants were screened and 64 were randomized; 63 participants were treated, and comprise the Safety Analysis Set.
742226|NCT01054703||
742227|NCT01054625||
742228|NCT01054599||
742229|NCT01054586|As this was an observational, retrospective study, no participants were recruited for participation in this study. For more information about this study, see the protocol in ClinicalTrials.gov and/or search for this study (111949) on http://www.gsk-clinicalstudyregister.com/.|
742230|NCT01054573|A total of 90 participants were enrolled and received treatment in the study: 9 participants from Phase 1 studies VX04-950-101 or Study VX05-950-103 and 81 participants from the Phase 3 study VX-950-TiDP24-C216 (NCT00703118) (referred to as the parent studies). The current study was conducted in 16 countries including the United States.|This study provided participants with access to telaprevir who were randomized to the control group in a previous Phase 3 study and failed therapy with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV) or to participants who received telaprevir as monotherapy or in combination with Peg-IFN-alfa-2a in 2 previous Phase 1 studies.
742231|NCT01054560|Subject enrolled from Feb 2010 to Feb 2011. Subject randomized to Solitaire or Merci by baseline National Institutes of Health Stroke Scale Score.|Study had Roll-in period. Participating centers in the United States were required to enroll two (2) roll-in subjects prior to the subject randomization. There were a total of 31 roll-in subjects. Only data from the randomized cohort was used for both primary efficacy analysis and the safety endpoint analysis.
742232|NCT01054456|Participants took part in the study at 18 investigative sites in the United States from 27 October 2009 to 08 December 2010.|A total of 38 participants were screened, of which 02 were screen failures and 36 participants were enrolled and received the study treatment.
742233|NCT01054404||23 patients enrolled sequentially, no dropouts
742234|NCT01054339|Subjects were recruited from two clinical trial sites (University of Massachusetts Medical Center and Cincinnati Children's Hospital Medical Center).|
742235|NCT01054300||
742236|NCT01054222|Participants who completed treatment in study A0221045 (NCT00798434) were included in this study as per investigator's discretion.|
742237|NCT01054209|February 2010- September 2012 Recruitment at preop assessment; consent on admission. Study location: obstetric ward and operating theatres|Entry into study phase on arrival in operating theatre. Final temperature readings to in the PACU
742238|NCT01054183|Prospectively enrolled 22 patients between 8/1/2010 - 5/1/2012.|Prior to the initiation of the study, staff received didactic and simulation based instruction with the Glidescope Video Laryngoscope (GVL) and demonstrated competency through a minimum of 5 successful intubations in patients >10 kg and 1 intubation in a patient < or = 10 Kg in a controlled operating room setting.
742239|NCT01054170|First patient enrolled: 06 January 2010; Last patient completed: 17 November 2010; Twelve centres across 5 countries participated in this study: Canada (2), Denmark (3), The Netherlands (2), Romania (2) and Ukraine (3).|Tiotropium maintenance therapy and reliever medication were commenced at screening, except for patients on inhaled corticosteroids (ICS, ICS/LABA) who were required to stop these at enrolment and commence on tiotropium and reliever medication at the same time. These patients received tiotropium for a period of at least 3 weeks before screening.
742240|NCT01054079||
742241|NCT01053988||Eligible participants (par.) completed a 2-week single-blind (placebo) Run-in Period (RIP) to assess Baseline rescue use, symptoms, disease stability. Par. were then randomized to a 24-week Treatment Period. A total of 1804 par. were screened, 1390 entered the RIP, of whom 1031 were randomized, 1030 received at least one dose of study medication.
742242|NCT01053962|This study was conducted between 3 March 2010 and 26 August 2010 at 14 study centers in the United States. Four dose cohorts were planned (0.3 mg, 1.0 mg, 3.0 mg, and 9.0 mg with 20 patients per dose cohort randomized in a 3:1 ratio [15 pts receive SP-304, 5 pts receive placebo].|During the pre-treatment period (Study Days -14 though -1), 84 eligible patients completed daily bowel movement diaries to obtain baseline data. Of these, 78 patients (58 and 20 patients for the SP-304 and placebo treatment groups, respectively) received at least one dose of study drug.
742243|NCT01053897|Subjects were screened and enrolled at two US centers (surgical practices) beginning in February 2010. The last subject completed participation in October 2011|
742244|NCT01053819||
742245|NCT01053741|Recruitment initiated September 2008, completed October 2009. Study participants recruited from previous trial participation and advertisements posted in the medical institutions.|
742246|NCT01053663||A total of 2428 participants were prescreened; of which, 2419 failed the prescreening evaluation. The most common reasons for failing the prescreening evaluation included the following: negative influenza diagnosis, not meeting the age criterion, ability to tolerate/absorb oral medication, and inability to comply with the study procedures.
742248|NCT01053429||Pediatric patients <18 years of age (N=105) were enrolled in error by some sites and were subsequently reported as protocol violations. Given that the objective of this Non-interventional study was to observe the safety and efficacy of Zeldox in real life, the data collected from these participants was included in the safety and efficacy analyses.
742249|NCT01053312||
742250|NCT01053247||
742251|NCT01053221||Out of 16 enrolled participants,1 participant never got randomized and 1 participant did not show up for any of the appointments. Only 14 started in the study.
742252|NCT01053156|Recruitment occurred from January 2010 to June 2011, with the last participants completing the study in December 2011. The study site was a single site, the MIND Institute at the University of California Davis Medical Center.|Inclusion criteria: FXS confirmed by FMR1 DNA, age 3.5-16 years and stable pharmacological regimen > 4 weeks prior to study. Exclusion criteria:previous minocycline treatment, plans to change pharmacological intervention or allergy to tetracyclines. 66 patients enrolled; 55 patients with any data on outcome measures analyzed (11 withdrawn).
742253|NCT01053078||
742254|NCT01053000||
742255|NCT01052948|Noninterventional retrospective cohort study.|
742256|NCT01052844|This was a prospective, double-blind, placebo-controlled study conducted at our institution (Faculdade de Medicina da Fundação ABC and affiliated Hospitals) from April 2009 to April 2010. Patients and personnel involved in the study were blinded to the assigned treatment.|Patients and personnel involved in the study were blinded to the assigned treatment. The study was approved by the ethics committee of our institution. All the patients provided written informed consent. No enrolled participants were excluded from the trial.
742257|NCT01052831||
742258|NCT01052779||
742259|NCT01052714|Recruitment from outpatient mental health clinics at four southern California VA facilities occurred from September 2010 through March 2014.|Participants were terminated from study prior to randomization to study groups due to screen failure or withdrawal from study during the baseline assessment period.
742260|NCT01052701|Subjects were recruited through general newspaper advertisements, flyers, and referral from providers specializing in hepatitis C|
742261|NCT01052662|Recruitment was done by newspaper advertising, referrals from the University of Massachusetts Addiction and Comorbidity Treatment Service (ACTS) and from community-based substance abuse clinics.|229 individuals of the 354 persons who were interested in the study were assessed not eligible to participate. Of the 125 subjects that were screen over one week, only 87 subjects meet criteria for study participation. Reason for exclusion included: declined (N=22), psychiatric (N=6), other SUD (N=6), abnormal labs (N=3) and medical reason (N=1)
742262|NCT01052545|The investigators reviewed the electronic medical record continuously at both sites to detect urine cultures and antibiotic use. At the intervention site, we reviewed 170,345 bed days over the 3 years of the project, while at the control site, we reviewed 119,409 bed days over the same time period. The intervention was delivered to the providers.|"From the bed days reviewed, we determined which patient had a positive urine culture that was associated with the presence of a urinary catheter. These cases were studied further to determine if antimicrobial use was compliant with guidelines or non-compliant. These cases became the numbers enrolled in each arm of this study."
742263|NCT01052480||
742264|NCT01052428||
742265|NCT01052272||
742266|NCT01052207||
742267|NCT01052116||
742268|NCT01052077|This trial was conducted in the United States in 773 participants at 44 centers. A total of 1226 participants were screened, 773 participants were enrolled in Phase A, and 769 were treated in Phase A. Of the 623 participants who completed Phase A, 372 participants were randomized in to Phase B.|A 7 to 28-day Screening period, 8-Week single-blind placebo-ADT (antidepressant therapy) prospective Phase, 6-Week double-blind randomization Phase (Phase B), and 30-day follow-up after last dose of medication. Any participant randomized/completed all visits through Week 14 were allowed into an open-label rollover trial (NCT01052077).
742269|NCT01052038|ASA physical status I and II females undergoing outpatient gynaecological laparoscopy. Patients with a history of recent respiratory tract infection (<1 month), current use of an opioid analgesic or corticosteroid, pregnancy, or anticipated difficult airways were not enrolled. Subjects were enrolled between January 2010 thru September 2010.|No subjects were lost or excluded after consent was signed and prior to allocation.
742270|NCT01051986|Patients, 40 to 75 years of age, who were scheduled to between September 2008 and October 2011 patients who undergo off-pump CABG (OPCAB) for multivessel coronary artery disease using a Y-composite graft based on the in situ left ITA were evaluated for eligibility|Exclusion criteria included patients with ineligible Y-composite graft revascularization, unavailable RITA or SV, left ventricular dysfunction, chronic renal failure requiring renal replacement therapy, a history of previous cardiac operation, emergency, or a medical history that might limit the possibility of mid-term follow-up
742271|NCT01051960|15 participants were screened, and 12 were eligible and enrolled in the study|
742272|NCT01051921||
742273|NCT01051856|Subjects were enrolled from January 2010 to March 2014 at Mayo Clinic in Rochester, Minnesota, and at Massachusetts General Hospital in Boston, Massachusetts.|
742274|NCT01051817||
742275|NCT01051791||
742276|NCT01051778|This study was conducted between June 2006 to December 2009 at Cairo university hospital and Ahmed Elgazzar hospital ,Cairo.|
742277|NCT01051739|We completed recruitment in the first three years of the grant period at out Visual Field Laboratory at the University of Iowa|see inclusion and exclusion criteria
742278|NCT01051661||
742279|NCT01051596||
742280|NCT01051570||
742281|NCT01051557||
742282|NCT01051518|Nine sites from Western Europe and Canada enrolled 126 subjects between May 2006 and November 2008.|Of 126 subjects enrolled, 124 were implanted with the CoreValve aortic valve.
742283|NCT01051466||
742321|NCT01049035|Study was conducted from 16 December 2009 to 13 February 2012 at 21 active sites in the United States.|A total of 580 participants who met all inclusion and none of the exclusion criteria were enrolled and randomized in the study.
742869|NCT01015443|First/last subject (informed consent): 03 Dec 2009/10-Sep-2014. Data cut-off date: June 2015; Subjects were randomized at 45 centers in 5 countries worldwide.|A total of 350 subjects were screened for eligibility and 285 subjects were enrolled and randomized.
742284|NCT01051440|The recruitment period began in June 2010 and concluded in early 2012. Recruitment was through media advertisements and patients in the hospital outpatient clinic. Out of hundreds of individuals who were pre-screened by telephone, 31 were invited to the clinic for screening visits.|Participants who were not on an approved mood stabilizer (lithium, valproate, or lamotrigine) at the time of enrollment were eligible for a one-month lead in to start a mood stabilizer prior to randomization. Several participants were excluded due to psychiatric co-morbidity, unclear diagnosis, history of stimulant use, or medical concerns.
742285|NCT01051349|Out of 410 enrolled participants, 60 participants who received at least 6 consecutive monthly doses of DAC HYP in this study and had provided written informed consent were enrolled in to the autoinjector substudy and 91 participants who received seasonal trivalent influenza vaccine were enrolled in vaccine substudy (exploratory analyses).|
742286|NCT01051323||Data of this non-interventional study were analyzed by the following strata: predialysis participants versus hemodialysis participants, unless otherwise specified.
742287|NCT01051310|Three sites in Germany enrolled 18 patients between June 2008 and January 2010.|All 18 subjects signed and informed consent and were admitted to the catheterization laboratory for an attempted implantation. All 18 subjects were subsequently implanted with the CoreValve device.
742288|NCT01051063||
742289|NCT01050998||A total of 516 participants were screened out of which 290 participants were randomized in the study.
742290|NCT01050946|FDA approval was granted on 6/18/11 and went into effect on 7/18/11.Recruitment period started from the 7/18/11 until study closure on 3/28/13, All recruitment took place in the clinic setting. Only one patient was accrued.|
742291|NCT01050907||
742292|NCT01050816|30 subjects who have ankle cartilage defects|
742293|NCT01050790|Potential patients will be identified at the first BMT consult. They will then be preliminarily screened. If deemed eligible, they will be consented at the second BMT consult. After consent the subject will be officially screened for eligibility as described in the protocol. If eligible they will be enrolled.|
742294|NCT01050764||
742295|NCT01050673||
742296|NCT01050660|Bewtween May 2009 -November 2012- infants born and admitted to NICU were enrolled.|
742297|NCT01050647||
742298|NCT01050634||
742299|NCT01050582|A total of 244 subjects were assessed for eligibility of whom 230 signed informed consent. Of the 230, 43 were found not to meet inclusion or exclusion criteria, 2 withdrew consent, and 1 was not kept in the study due to a site decision. A total of 184 subjects were included in the analysis.|
742300|NCT01050569|Oct 2008 to September 2011 Location was at the University of Minnesota Twin Cities and Duluth, Minnesota|After signing consent and before randomization to groups, 44 were lost to follow-up, 17 were ineligible, 10 were no longer interested, 10 were family members of enrollees.
742301|NCT01050543||
742302|NCT01050530||
742303|NCT01050257||This study included a 5 day treatment period and an optional extension. Participants were considered to have completed treatment if they completed the 5-day course of treatment (IV and/or oral).
742304|NCT01050218|Patients were recruited in the United States from July 2006 to September 2008.|Outpatients must have completed double-blind treatment and all scheduled evaluations in study 3151A5-322 (NCT00283842), with no major protocol violations and no events that, in the opinion of the investigator, would have precluded the subject's entry into the long-term open-label study.
742305|NCT01050205|Individuals were recruited via screenings in 3 community settings: a) a local work site, b) 3 community/senior centers, and c) a military medical facility. The military medical facility was a pre-post study not an RCT. Results are presented for the RCT sites. Recruitment at these sites began in Fall of 2010 and was completed in Winter of 2013.|
742306|NCT01050153|50 consecutive eligible patients admitted to the Surgical Intensive Care Unit following trauma between March 2010 and December 2011 were enrolled in the study.|
742307|NCT01050062|A total of 1452 patients were enrolled. Of these patients, the CRFs of 9 patients were uncollected by reason of institution, and the 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey.|
742308|NCT01049984||
742309|NCT01049945||
742310|NCT01049802||
742311|NCT01049776||
742312|NCT01049581|A convenience sample of 27 children was recruited for the study from the outpatient clinics of the Department of Physical Medicine and Rehabilitation of two tertiary hospitals: Chang Gung Memorial Hospital and Taipei Veterans General Hospital.|Exclusion * Children receiving botulinum toxin injection or surgery within 3 months * psychiatric diseases or communication disorders * poorly controlled epilepsy, * skin problems such as open wound
742313|NCT01049503|This randomized, double-blind clinical trial was approved by the Institutional Review Board of Bauru Dental School (protocol 016/2009). It involved 2 to 4-year-old children that attended five public primary schools, each localized in a different geographical region of Bauru, São Paulo, Brazil (0.6-0.8 ppm F in the drinking water).|From 876 children of the 5 selected schools, 487 did not fill the informed consent. From those who filled the informed consen, 74 missed the clinical examination day or filled the exclusion criteria (had participated in other researches in the last 3 months or children using orthodontic appliances). The total number of children enrolled was 315.
742314|NCT01049412||This is an open-label, randomized, 2-arm crossover study. The study consisted of two 8-week periods (Periods I and II) during which participants received Glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence.
742315|NCT01049373|hospital, 5.12.2003 - 5.5.2007 (first patient in / last patient out)|screening visit (up to one week before baseline)
742316|NCT01049360|The study was conducted in a total of 20 study centers in the United States. The first patient was screened in December 2009 and the last patient visit was in August 2010.|
742317|NCT01049334||Two hundred twenty-seven patients were screened.
742318|NCT01049308||
742319|NCT01049243|Participants were enrolled from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clininc|
742320|NCT01049217||All participants received placebo matched to pregabalin capsule orally twice daily for 2 weeks in placebo lead-in phase prior to randomization.
742385|NCT01045031|Of 136 initially screened individuals (63 athletes, 73 controls), a total of 114 subjects could be enrolled since they met all inclusion criteria.|
742322|NCT01049009|Subjects recruited from the general medical clinics of The Emory Clinic, Emory University Hospital, and Grady Memorial Hospital between January 2010 through January 2012.|91 subjects were enrolled but 47 subjects were withdrawn prior to group assignment due to various factors, which included eligibility criteria, lost to follow-up, and withdrawal by subject.
742323|NCT01048944|Recruitment: 9/01/06 to 9/01/11. Recruitment was throughout Carbondale and surrounding communities and occurred with newspaper ads, flyers, radio and television presentations. Recruitment was more challenging than expected because of the large time commitment and high prevalence of psychoactive medication and drug use (exclusionary criteria).|After consent subjects and the completion of their first experimental session subjects were randomly assigned to one of 4 treatment arms: 197 signed the consent, 126 completed the first experimental session and were subsequently randomly assigned to a treatment condition.
742324|NCT01048879||
742325|NCT01048866||Three hundred and thirty-six patients were screened.
742326|NCT01048788||
742327|NCT01048723|40 patients were to be treated with RAD001 in a neoadjuvant pre-resection manner 10mg po daily x 2 weeks with resection of their extremity or retroperitoneal tumors within 2 weeks after the conclusion of therapy. All patients with resectable sarcomas by CT or MRI imaging without evidence of distant metastases would be eligible for the trial.|The sarcomas must be amenable to percutaneous needle core biopsy prior to initiation of RAD001 therapy.
742328|NCT01048697|Recruitment of volunteers by fliers.|
742329|NCT01048671||Of 482 participants included in the trial, 2 were excluded from analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.
742330|NCT01048658||
742331|NCT01048606||
742332|NCT01048593||
742333|NCT01048541||
742334|NCT01048502|100 subjects were enrolled; 80 completed the study.|
742335|NCT01048424||
742336|NCT01048333|Patients recruited at 14 clinics in 3 countries: Sweden (4 clinics); Italy (6 clinics); Spain (6 clinics)between January and May 2010|141 patients enrolled; 32 excluded: 28 due to eligibility criteria not fulfilled and 4 for subject decision
742337|NCT01048242||
742338|NCT01048125|2 participants were consented, but due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.|
742339|NCT01048099|Pts with HER2-negative, metastatic breast cancer were enrolled. Blood was collected to perform the PRO Onc Circulating Tumor Cell (CTC). Pts without CTCs present were taken off-study. Following the assay, pts without detected HER2 overexpression/activation were taken off-study. Of the remaining pts, those FISH-positive for HER2 came off-study.|
742340|NCT01047839||
742341|NCT01047709|This is a crossover study. One night with positional therapy (intervention) and one night of sleeping ad lib (control). The order was randomly assigned. Subjects were enrolled between 12/2008 and 2/2010.|
742342|NCT01047553|The first participant entered the study on 18 December 2009, and the last participant completed the study on 20 July 2011. A total of 320 participants were enrolled at 30 centers in Japan, and 251 participants who fulfilled the randomization criteria were randomized.|The study started with an enrolment visit, Visit 1, 1 week prior to Visit 2, and 1 week run-in period before randomization. At Visit 2 participants had to have pre-bronchodilatory forced expiratory volume in one second (FEV1) less than 80 percent of the predicted normal value.
742343|NCT01047527||
742344|NCT01047475||
742345|NCT01047436|Patients were recruited at a single study centre in Rwanda during December 2009.|
742346|NCT01047358|Participants were enrolled between June 2010 and June 2014 from 25 Korean health care centers.|
742347|NCT01047345||
742348|NCT01047332||
742349|NCT01047319|All participants who completed the full duration of the double-blind BRAVO study (study MS-LAQ-302) were eligible to enter into Study MS-LAQ-302E. Of the 1090 participants who completed MS-LAQ-302, 1047 opted to continue into the open-label extension study.|1047 subjects with RRMS were enrolled to receive laquinimod 0.6 mg daily at 144 study sites in 18 countries by 144 investigators.
742350|NCT01047306||
742351|NCT01047293||
742352|NCT01047241||
742353|NCT01047189|Participants were recruited from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clinic|
742354|NCT01047007|This study enrolled participants with a confirmed locally advanced or metastatic solid tumor failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Additional inclusion and exclusion criteria applied.|Participants received MK-1775 (Part 1), MK-1775 + 5-Fluorouracil (Part 2A), and MK-1775 + 5-Fluorouracil and cis-diamminedichloroplatinum (Parts 2B and 3). The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-Fluorouracil (5-FU) and cis-diamminedichloroplatinum (CDDP) regimen.
742355|NCT01046903||
742356|NCT01046877|Consecutive eligible patients presenting to the study site and for whom tube insertion was recommended were offered the opportunity by the investigator to participate in the study.|
742357|NCT01046695|Subjects were recruited from individuals undergoing video-assisted thoracic surgery at the Mayo Clinic in Rochester, Minnesota from March 18 through September 22, 2010.|"56 subjects enrolled, but 14 subjects didn't start and receive the intervention. On the TENS Unit arm, 1 went straight to the ICU, 1 refused stating no pain to treat, and 4 did not have a VATS or had a thoracotomy. On the control arm, 1 did not have a VATS, 1 had an defibrillator, 3 went straight to the ICU, and 3 did not get started by nursing."
742358|NCT01046682||
742359|NCT01046669|450 subjects randomized out of 921 clinically eligible subjects in 55 ICUs. First patient screened in Jun 2010, last patient screened in Jun 2016.|"The following screened subjects were not randomized:
~Subject's EAA <0.06 EA units
~Subject met an exclusion criteria prior to randomization
~Informed consent for the treatment phase of the study was not signed or consent withdrawn prior to randomization.
~Subjects who were randomized but not treated (RNT) were not part of safety analysis."
742386|NCT01044966||
742387|NCT01044862||
742388|NCT01044771||
742870|NCT01015326||
742871|NCT01015287||
742872|NCT01015170||
742360|NCT01046643|+++__Women were recruited from 3/1/2010 to 7/29/2011 through local newspaper ads, flyers, electronic newsletters, bulletin boards, clinics and the Women's Health Registry, a University of Michigan database of women interested in participating in women's health related clinical research.|Several enrolled participants were excluded from the trial prior to assignment in groups on the basis of the risk factors identified at the pre-screening appointment. Some others did not qualify due to their lab results which did not meet the inclusion criteria.
742361|NCT01046565|"Dates of recruitment period: First subject was enrolled on January 11, 2010 and the last subject was enrolled on January 11, 2010.
~Types of location: Investigative site was located at a research center."|Wash-out period up to baseline for topical treatment on the treated area was less than 1 week for corticosteroids and/or 4 weeks for retinoids; for systemic treatment, it was less than 1 week for medications that may have increased photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
742362|NCT01046396|"Dates of recruitment period: First subject was enrolled on January 11, 2010 and the last subject was enrolled on January 13, 2010.
~Types of location: Investigative site was located at a research center."|Wash-out period up to baseline for topical treatment on the treated area was less than 1 week for corticosteroids and/or 4 weeks for retinoids; for systemic treatment, it was less than 1 week for medications that may have increased photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
742363|NCT01046253||
742364|NCT01046136|Participants were recruited from waiting rooms of health care providers/clinics between December 2009 and March 2010.|Participants screened over 2 day period who suffer from an acute respiratory tract infection.
742365|NCT01046110|The trial was conducted at 78 sites in 7 countries: Argentina (2 sites), Canada (11 sites), India (8 sites), Mexico (2 sites), South Africa (3 sites), Turkey (5 sites) and the United States (47 sites).|
742366|NCT01046084||
742367|NCT01045993|Participants were recruited who had primary muscular low back pain (in the Investigator's best judgment), which was atraumatic (no traumatic injury within 48 hours of enrollment) and not caused by, or related to, any clinically significant, medical diseases, whose onset had occurred within the past 3 months.|"Eligible participants with at least moderate pain intensity on a 6-point categorical scale were randomized (N=61) to primary efficacy (heatwrap or oral placebo) or blinding groups (sham wrap or oral Ibuprofen). May have received rescue medication (oral acetaminophen) during the 4-hour evaluation period or at discharge after assessments completed."
742368|NCT01045967||
742369|NCT01045798||"This study was terminated early due to low participant enrollment.
~One of the 15 participants randomized to treatment inappropriately received a systemic antifungal agent before starting study drug and was not included in the baseline characteristics, safety, or efficacy analyses."
742370|NCT01045707|The trial was conducted at 88 sites in 8 countries: Austria (4), India (7), South Korea (5), Poland (6), Russia (10), Spain (11), Turkey (5), and United States of America (40). Some sites did not enroll subjects in the extension period.|The total duration of treatment was up to 52 weeks (26 weeks [main trial: NN5401-3590, NCT01045707] + 26 weeks [extension trial: NN5401-3726]), separated by 1 week of wash-out period; during which subjects were treated with Neutral Protamine Hagedorn (NPH) insulin twice daily (BID) in combination with subject's pre-trial treatment of metformin.
742371|NCT01045694|Study had 8 enrollments: 6 completed and 2 withdrew voluntarily. Study was terminated early due to lack of funds. No data analysis was completed.|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group.
742372|NCT01045551|10 patients recruited|
742373|NCT01045499|Adolescents aged 13 to 18 years were enrolled in this study.|The age range for the enrolled adolescents at the time of surgery was 14-19 years of age since some aged from the time of consent to surgery.
742374|NCT01045460||One subject was a screen failure.
742375|NCT01045447|The trial was conducted at 61 sites in 9 countries: Croatia (2 sites), France (4), India (8), Poland (4), South Africa (3), Republic of Korea (6), Sweden (5), Turkey (5) and United States of America (24).|
742376|NCT01045421|Participants took part in the study at 42 investigative sites in France, Poland, the Czech Republic, and the United States from 16 February 2010 to 25 April 2014.|Participants with a historical diagnosis of relapsed or refractory advanced nonhematological malignancies were enrolled in 1 of the 2 stages, Phase 1 (lead-in alisertib dose escalation stage) and Phase 2 (efficacy and safety assessment stage for alisertib dose determined in Phase 1).
742377|NCT01045265||
742378|NCT01045187|Recruitment was from September 2008 through October 2009. The centers were at Hospitals and free-standing radiation oncology clinics.|Patients who were candidates for vaginal brachytherapy post TAH-BSO with or without EBRT were enrolled. Patient participation was voluntary for this data collection study.
742379|NCT01045174|Study participants recruited from eligible children who presented to a pediatric emergency department at the single study site with acute asthma exacerbation/status asthmaticus. Recruitment for this study is now closed.|180 participants were enrolled in the study. No enrolled participants were excluded from the study before assignment to groups.
742380|NCT01045161|Patient recruitment occurred from December of 2009 to June of 2010 at 112 study sites (110 in the United States and 2 additional sites in Canada).|A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.
742381|NCT01045135|January 2010 - july 2011|
742382|NCT01045122|Dates of recruitment April 2006 to November 2008. Subjects were recruited from advertisements, patient letters sent out through the strong sleep center.|Subjects excluded from trial before assignment to group because Prior airway surgery, unstable medical conditions.
742383|NCT01045096|Participants took part in this study at 3 investigative sites in the United States from 04 March 2010 to 09 February 2011.|36 participants with gastroesophageal reflux disease were assigned to 1 of 3 once daily (QD) treatment regimens (15 mg, 30 mg or 60 mg dexlansoprazole) based on baseline body weight.
742384|NCT01045057|Prospective study, carried out in 5 different medical centers in 4 different countries. Recruitment period runs from November 2009-March 2011|
742695|NCT01025453||
742696|NCT01025427||
742389|NCT01044758||Data for the 125mg BID treatment cohort was collected first. Analysis showed no effects of treatment order. As a result, data was collapsed and analyzed irrespective of order across all doses. All subsequent data analyses are thus provided collapsed across treatment orders in all reporting on this study, including the results reported here.
742390|NCT01044745||
742391|NCT01044732||
742392|NCT01044706|healthy subjects recruited in April 2005 by sfbc Anapharm at 2050, Boul. Rene-Levesque Quest, Saint-Foy, Quebec, Canada G1V 2K8|This was a single center, bioequivalence, open-label, single-dose, 1-way parallel study
742393|NCT01044693||
742394|NCT01044589||
742395|NCT01044537||
742396|NCT01044498||
742397|NCT01044459|Patient recruitment occurred from November of 2009 to April of 2010 at 109 study sites (106 sites in the United States and 3 additional sites in Canada). A total of 97 study sites randomized patients (94 in the United States and 3 in Canada).|A 2-week run-in period was used to assess the stability of patients' disease and to establish each patient's baseline characteristics. The run-in period was followed by a 52-week double-blind treatment period.
742398|NCT01044433||
742399|NCT01044303||
742400|NCT01044290|A total of 221 patients were recruited from the outpatient clinics and nursing home care unit from the Durham VA Medical Center from 1/2011 to 12/2013. Patients were eligible if they were considered to have serious life-limited disease, identified by clinical criteria, with staging/prognosis confirmed by a provider.|Eligible participants were consented, screened with the Mini Mental Status Exam (MMSE), given a baseline interview, then randomized to group. Reasons for not randomizing participants included death, drop-out, unable to contact, and study removal due to non-eligibility.
742401|NCT01044264|FIRST PATIENT ENROLLED: 12/11/2007 LAST PATIENT COMPLETED: 9/18/2008|
742402|NCT01044212|Candidates meeting criteria were offered participation at their preoperative visit.|
742403|NCT01044056||
742404|NCT01044030||
742405|NCT01043939|Participants were recruited from the Metabolic Syndrome Study in Childhood Cancer Survivors and the Long-Term Follow-up Clinic, both at the University of Minnesota, Minneapolis, MN between October 2009 and May 2010.|30 recruited; 6 drop-outs during 4 week run-in period, prior to randomization due to now-show for first clinic visit or concerns regarding time, compliance, or blood draws.
742406|NCT01043926||16 participants were enrolled in Part I of the study. Because the primary hypothesis was met, no participants were enrolled in Part II of the study.
742407|NCT01043874||
742408|NCT01043705|First Patient Enrolled = 1 January 2010; Last Patient Enrolled = 7 May 2013|CRT and ICD Implant patients with TYRX Implant; Full analysis cohort = 1,129 patients. 670 patient CRT + TYRX cohort is subset. 459 patient ICD + TYRX is subset. 578 CRT+ TYRX patient cohort is subset matched to 578 patient CRT/no TYRX retrospective patient arm.
742409|NCT01043653||
742410|NCT01043640||
742411|NCT01043562||
742412|NCT01043523|Pediatric subjects (> 2 months and < 18 years of age), who underwent a contrast-enhanced (CE) liver magnetic resonance imaging (MRI) with Eovist/Primovist because of suspected or known focal liver lesions, and who had evaluable safety and efficacy data.|Of the 52 subjects that were identified by the investigators for participation in this observational/retrospective study, 51 were included in the efficacy analysis. One subject (22001-0005) did not have unenhanced images. The safety analysis was performed on all 52 subjects.
742413|NCT01043432||
742414|NCT01043393||
742415|NCT01043185||
742416|NCT01043146||
742417|NCT01043133|All 3rd year USU medical students rotating through Family Medicine clerkship were invited to participate. The clerkship groups scheduled every 6-8 weeks during the 2009/10 academic year. The study included both male and female participants; ratio based on assignment to rotation group which is predetermined by medical school administrative staff.|
742418|NCT01043094|Study period was from 23 November 2009 to 07 June 2010 All subjects were seen at a medical clinic|
742419|NCT01042977|First participant enrolled 15 Mar 2010, last part. last visit for 24-week period: 30 May 2011. 1489 part. enrolled, 964 randomized in USA, Canada, Australia, Chile, Argentina and 5 European countries (value presented in 'Enrolment' field). One add. part. treated but not randomized. Part. with T2DM and CVD who showed inadequate glycemic control.|During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Anti-diabetic therapy should be kept constant 4 weeks prior to enrolment. Participants eligible for the study were stratified according to age (<65 years or ≥65 years), insulin use and time from most recent qualifying CV event (>1 or ≤1 year).
742420|NCT01042938|Enrollment for this trial began January 18, 2008 and ended on January 27, 2010. All patients were recruited and treated at the University of Rochester Cancer Center. Of the 213 breast cancer patients prescribed radiation therapy during this timeframe, 67 patients were approached for particiaption in the trial.|
742421|NCT01042795||
742422|NCT01042678||
742423|NCT01042613|148 total patients were recruited at single institution (SJCRH) study between Jan 13, 2010, and March 03, 2011.|148 total patients were enrolled on the study. The report is based on results for 146 patients. Two patients were excluded from this study. One patient was excluded due to MD's decision and the other patient was deemed to be inevaluable after study enrollment (cannula gauge other than 22 were used).
742424|NCT01042600||One participant excluded and removed from study after randomization due to ineligibility (pre-existing pneumothorax)
742425|NCT01042535|Participants were recruited at Moffitt Cancer Center from December 28, 2009, through February 11, 2014.|
742426|NCT01042509||
742427|NCT01042496|Subjects were recruited from the Mayo Clinic in Rochester, Minnesota.|39 subjects signed informed consent for the Bipolar Group, but 9 were screen failures, and one subject signed consent but did not start the study. 33 subjects signed informed consent for the Healthy Control group, and all of these subjects completed the study.
742428|NCT01042392||
742429|NCT01042366||Although 16 subjects were enrolled, one subject was referred to hospice and never began the study.
742430|NCT01042288||One patient signed the consent but had a stroke prior to the pre-treatment and Cycle 1-Day 1 visits.
745227|NCT00891813||A total of 114 participants were screened. Of those, 100 participants were enrolled and received at least one dose of study drug.
742431|NCT01042236||Participants randomized to receive sequenced dosing of Fesoterodine 4 milligrams (mg) (A), or Fesoterodine 8 milligrams (B), or Placebo matching study treatment (C). Each dosed for 7 days with a 7 day washout between dosing periods. Dosing sequenced as ABC, ACB, BAC, BCA, CAB, or CBA.
742432|NCT01042158|This study had recruitment of patients from four centers, namely Johns Hopkins University, Stanford University, University of Texas Southwestern Medical Center, and the Cleveland Clinic. Patients who fulfilled the inclusion and exclusion criteria were screened for enrollment between August 25, 2011 and February 4, 2014.|This was a one arm study and patients were therefore selected based on the inclusion/exclusion criteria.
742433|NCT01042145|Children were recruited from 10 primary care pediatric practices over two winters: between October 26, 2009 and April 16, 2010; and between September 6, 2010 and April 29, 2011.|103 children were assessed for eligibility. 16 were excluded prior to randomization. reasons were: did not meet inclusion criteria (10), declined to participte (6).
742434|NCT01042093|All patients scheduled for Total Knee Replacement (TKR), by the investigator and considered suitable for participation,were recruited for the study from Jan 2010 through June 2011.|Before assignment to groups all participants were screened for certain exclusion criteria including; pregnant/lactating women, allergies/contraindications to study medications/spinal anesthesia, drug/alcohol abuse, psychologic disorder, diagnosis of inflammatory arthritis, previous major surgery to operative knee, and simultaneous bilateral TKR's.
742435|NCT01041976|Participants were recruited from a variety of clinics at the Edith Nourse Rogers Memorial VA Hospital including: the Psychosocial Rehabilitation and Recovery Center, Mental Health Intensive Case Management (MHICM), outpatient Prolixin and Clozaril clinics, VA Supported Housing (VASH), and the psychiatric inpatient unit.|168 participants enrolled, 115 veterans+53 family/key friends willing to participate, a criterion only for 3/2011-3/2012 recruitment. Veterans completed screening interview and if eligible completed the informed consent process and baseline interview. During 1st session with individual research clinician 84 Veterans were randomized to AMI or SER.
742436|NCT01041859||In a 3-week open-label (OL) period, patients titrated to an optimal dose between 100 mg and 250 mg twice daily. Patients with >=1-point reduction in pain intensity at the end of OL period were randomized. 38 of 358 who completed OL were not randomized: <1-pt reduction(28), withdrew consent(4), non-compliant(2), adverse events(1), other reason(3).
742437|NCT01041781||
742438|NCT01041638||
742439|NCT01041573||
742440|NCT01041521||12 participants were enrolled but the did not participate due to 1) declining to participate, 2) inability of study team to locate participant, or 3) moving out of state.
742441|NCT01041417|Between January 2010 and July 2012, 322 individuals with peripheral artery disease were assessed for eligibility. 159 subjects were enrolled into the study from Emory Healthcare, Veterans Affairs hospitals in Atlanta, and Medical College of Georgia.|
742442|NCT01041404||
742443|NCT01041287|Patients recruited from clinic sites at Emory University Hospital and by advertisements between December 2009 through April 2012.|There were 96 subjects enrolled. 58 of the subjects were withdrawn prior to group assignment. 39 subjects did not meet eligibility criteria and 19 subjects withdrew.
742444|NCT01041274||
742445|NCT01041209||
742446|NCT01040871||164 participants were randomized, three participants did not receive study treatment (2 in the VR-CAP and 1 in the R-CHOP arm) for a total of 161 treated.
742447|NCT01040858||
742448|NCT01040845|Thirty (30) healthy, non-smoking, premenopausal adult female volunteers, consisting of university students and members of the community at large, were to be enrolled.|51 subjects screened, 21 were screen failures
742449|NCT01040832|First participant enrolled: 17 Dec 2009; Last participant signed informed consent: 15 Aug 2011; Clinical data cut-off: 11 Jan 2012.|Of the 123 participants, 106 were randomized and 17 were screen failures (12 did not meet all eligibility criteria, 1 experienced progressive disease, 3 had unspecified reasons and data on 1 participant was missing). One participant who was not randomized but received cetuximab+EMD 1201081, was included in the safety population (107 participants).
742450|NCT01040819||
742451|NCT01040793||This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
742452|NCT01040780|Patients were enrolled between 26 Febrary 2009 and 13 November 2010 across 27 study sites.|
742453|NCT01040728||This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
742454|NCT01040689||This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
742455|NCT01040624||
742456|NCT01040403||This was a randomised, 4-period incomplete cross-over trial. 233 patients were randomized to one of 14 treatment sequences and 232 of them were treated. It was a double-blind trial in which each treatment period lasted 4 weeks with a washout period of 21 days between each.
742457|NCT01040351|This study was two arm prospective randomized controlled study including 110 fresh IVF- ETs from 110 patients , undertaken between October 2006 to May 2010 at the assisted conception unit of Ahmed Elgazzar hospital , Cairo , Egypt.|
742458|NCT01040260||
742459|NCT01040208||
742460|NCT01040169|Recruitment, screening and enrollment completed at the clinic site|
742461|NCT01040130||This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
742462|NCT01040052|Participants were enrolled from 06 to 13 December 2009 in 1 medical center in Vietnam.|A total of 30 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and evaluated.
742463|NCT01039792|Children were recruited from the Autism clinic, an advertisement on Craigslist.org and letters to families of current and previous patients, between 12/8/10 to 10/22/13.|Enrolled patients excluded from the trial prior to assignment phase were attributed to inattention/inability to focus, increased hyperactivity/stimming, lack of efficacy, challenging behavior- parent request to drop out
742464|NCT01039688||
745228|NCT00891774||
745229|NCT00891735||
742465|NCT01039675||Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 5- to 8-day Run-in period and were then randomized to a 4-week treatment period. A total of 77 par. were screened; 52 par. were randomized and 51 par. received at least one dose of study drug (one par. was randomized in error but did not receive study drug).
742466|NCT01039584||
742467|NCT01039519||Thirty-one patients were screened; 4 of the 31 were screen failures.
742468|NCT01039467|Enrollment period: 18 JUN 2009 to 15 MAR 2010.|6 patients withdrawn from study pre-randomization for not meeting inclusion/exclusion criteria.
742469|NCT01039428||Sixty eight HD patients maintained on calcium carbonate (33 subjects) or sevelamer (35 subjects) were enrolled during January - April, 2010. Sixty-three patients chewed at least one gum: 35 HS219 and 28 placebo.
742470|NCT01039376||Eligible participants were stratified based on complete or partial remission at study entry, number of previous induction treatments (2 versus 3) and type of prior treatment (chemoimmunotherapy, only alkylating monotherapy, or other treatment). Participants were then randomized in a 1:1 ratio to receive ofatumumab or no further treatment.
742471|NCT01039207|This trial was opened to patient entry on October 10, 2010 and was closed to accrual on May 10, 2011.|
742472|NCT01038921|"Recruitment period from 05/24/2010 through 12/15/2011. Recruitment was from subjects from the Screening for Impaired Glucose Tolerance: Glucose Challenge versus Predictive Model NIH study R18DK066204,from Preventive Cardiology Clinic at Emory University Clinic and from advertisements placed on the campus of the Emory Clinic"|One week run in period on placebo. Six week washout period between crossover.
742473|NCT01038869|Subjects recruited from private office population.|
742474|NCT01038856|we conducted a single arm, prospective phase II study at the University of Oklahoma Health Sciences Center and the Oklahoma City VA hospitals in patients withWHO-defined JAK2V617F-positive PV from June 2010 to August 2012|Patients were eligible for the study if they were at least 18 years of age and had a diagnosis of PV per WHO 2008 criteria. Additional eligibility criteria included adequate liver and kidney function tests and an ECOG performance status of 0, 1, 2, or 3.
742475|NCT01038752|A total of 164 subjects were expected to be enrolled in this study; however, only a total of 14 subjects were enrolled at two active sites. Site 001 (Virginia Commonwealth University) enrolled 4 subjects and site 002 (Cook County) enrolled 10 subjects for a total of 14 subjects.|
742476|NCT01038713|The protocol initially was designed to measure five groups - we elected not to study patients with unresectable disease and thus only patients with presumed resectable disease are included|94 patients recruited for the study. 63 were randomized into three arms
742477|NCT01038687||
742478|NCT01038635|Recruitment Period: December 23, 2009 to June 21, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the 94 participants registered, six were ineligible therefore not assigned to groups nor treated.
742479|NCT01038609||
742480|NCT01038557||
742481|NCT01038336||
742482|NCT01038323||
742483|NCT01038128||
742484|NCT01037881|Participants received investigational medicinal products for up to 4-weeks followed by a 28 day follow-up period.|
742485|NCT01037452||
742486|NCT01037309|3 Subjects were recruited to each of cohorts 1-6 (total n=18) for SC administration PRO044 9 of these 18 subjects were recruited to cohorts 7-9 (n=3 in each cohort) for IV adminstration PRO044|3 Subjects were recruited to each of cohorts 1-6 (total n=18) for SC administration PRO044 9 of these 18 subjects were recruited to cohorts 7-9 (n=3 in each cohort) for IV adminstration PRO044
742487|NCT01037244|Enrollment began 28 Sep 2009|
742488|NCT01037218|First Subject enrolled 28-Sep-2009|
742489|NCT01037192|Subjects were recruited from March to September 2010 from patients from the Outpatient Antibiotic Intravenous Therapy clinic at the Royal Columbian Hospital, New Westminster, BC, Canada.|Subjects were excluded from the trial based on the inclusion and exclusion criteria. The main reasons for exclusion include age and weight.
742490|NCT01037127|The study used a 2-stage, Green-Dahlberg design that permitted stopping the trial for futility if <3 objective responses were observed in the first 30 participants enrolled. If >=3 objective responses were observed, 55 participants could be enrolled in each cohort.|
742491|NCT01037114||1 subject who was not able to come at Year (Y) 16 entered the study at Y17. At Y16, 1 subject was administered a challenge dose of Engerix-B vaccine and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix vaccine. None of the subjects received a challenge dose at Y17 and Y19.
742492|NCT01037088|Recruitment took place at the UCDMC and VA Northern California Pain clinics,UCDMC Spinal Cord Injury Clinic, and newspaper advertisements. Between December 2009 and March 2011, 59 patients were consented to enroll in the study.|Twenty subjects did not receive study medication: 9 withdrew for various reasons and 11 were disqualified following a medical evaluation with subsequent disclosure of exclusionary criteria on a physical exam or laboratory finding.
742493|NCT01036802|Patients were randomized 1:1 to receive anticoagulation with warfarin or placebo after evaluation in the clinical and translational research center. Enrollment began in January 2010 and ended in September 2012 due to poor patient accrual.|Following patient identification, an open-label run-in period was begun to ensure patient doses of warfarin could be titrated to a stable level that achieved an international normalized ratio between 2.0 and 3.0 without exceeding a dose of 15 mg per day and to exclude patients with a level of compliance less than 80% (based on pill counts).
742494|NCT01036763||
742495|NCT01036724||
742496|NCT01036594|Participants were recruited through the Urologic Oncology Program at University of California, San Francisco|All participants were prescribed ketoconazole for a 7 day run-in phase, then hydrocortisone + ketoconazole treatment. Participants not achieving >=30% PSA decline at 12 weeks were taken off study. Participants continued treatment until progression at which time, hydrocortisone was discontinued and ketoconazole + dexamethasone treatment began.
742497|NCT01036529|Subjects were recruited for participation from February 2010 to June 2012.|A total of 274 subjects were screened for participation.After screening, 75 subjects were eligible for participation. Of the eligible subjects, 47 declined randomization. A total of 28 subjects were randomized.
742498|NCT01036490|Subjects were recruited from the outpatient medical clinics of Hines VA Hospital over the three-year period between January 2011 and January 2014|
742499|NCT01036438||
745267|NCT00889603||
742500|NCT01036321|Participants were enrolled from January 2010 through May 2014 at three sites in Florida.|75 were consented and were further screened for final eligibility. 3 were ineligible and 1 withdrew after screening, before randomization. 71 were randomized. 1 was ineligible after randomization.
742501|NCT01036165|103 subjects were recruited from 15 US clinics in the US during the trial period February 2010 to August 2010|Subjects who signed informed consent and satisfied the eligibility critera at screening returned to the clinic on study day 1 to begin treatment with the Rebismart autoinjector. All subjects participating in the trial received Rebif 44 mcg sc tiw using the Rebismart autoinjector for 12 weeks.
742502|NCT01036022|The study was conducted at 21 centres in Europe and 5 centres in Canada from 15 September 2009 to 29 July 2012.|A total of 78 participants with mild-moderately active ulcerative colitis not limited to the rectum were randomized in the study to receive oral dose of 4 dose levels (10 milligram [mg], 30 mg, 100 mg and 300 mg) of GSK1399686, asacol or placebo.
742503|NCT01036009||5 eligible patients relapsed/died before assignment to a study arm
742504|NCT01035944||
742505|NCT01035905||
742506|NCT01035788|88 couples (88 Veterans & their 88 intimate partners) were consented & 78 couples completed eligibility screening. 32 couples were excluded (not meeting inclusion/exclusion criteria; met criteria but declined to proceed, or unable to attend required retreat weekend. The remaining 46 couples were randomized (46 Veterans & 46 partners).|
742507|NCT01035749||310 subjects were enrolled in the study, all of which were vaccinated and completed the Day 42 visit.
742508|NCT01035658||
742509|NCT01035606|Participants were referred for this study by their physicians and treatment providers due to history of acquired brain injury and chronic cognitive complaints involving distractibility and difficulties with problem solving, organization, and multitasking|
742510|NCT01035463||74 participants were consented, but only 59 subjects were treated on the study.
742511|NCT01035346||
742512|NCT01035333|Dates of recruitment 10.14.09 to 12.15.10 Outpatient clinic, Bariatric treatment Center|
742513|NCT01035255||
742514|NCT01035229|763 patients screened, 546 randomized. At 14Jun2013 data cut-off (final analysis), 3 pts in everolimus arm, 6 in placebo arm were still on treatment. Of 9 pts, 3 receiving placebo discontinued due to disease progression. Remaining 6 completed study due to sponsor's decision to end study after final results. The LPLV was 15Oct2013.|
742515|NCT01035151|Of the 34 subsidized housing neighborhoods in these two regions, the study was implemented in the 14 neighborhoods that met eligibility. Seven matched pairs were formed and randomly assigned one neighborhood in each pair to either the treatment condition or a delayed control condition. 27-32 participants enrolled in each neighborhood.|Common reasons for exclusions were not a resident of the neighborhood, not an active smokers.
742516|NCT01035138||
742517|NCT01035099||41 subjects were enrolled; One subject 1 later withdrew consent prior to randomization.
742518|NCT01035073||The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.
742519|NCT01035060|From September 2010 through December 2011, community-dwelling persons were recruited to participate through a variety of methods including media articles, direct mailings, newspaper announcements, and presentations to community groups.|
742520|NCT01035047|Recruitment occurred in the Emergency Department (ED) at Wake Forest Baptist Medical Center from March 2010 to June 2011.|No participants were excluded from the trial prior to treatment assignment.
742521|NCT01034709||
742522|NCT01034657|The study was divided into a core phase and a randomized phase. The core phase had an open-label single arm study design. The randomized phase was open-label with two parallel treatment arms for participants with stable disease. Participants with Hematological response of the erythropoietin system remained on single agent oral LBH589.|Participants with stable disease were eligible for randomization to single agent LBH589 or LBH589 + epoetin alfa. Participants with progressive disease were discontinued. Seven participants who completed the core phase withdrew before the randomization phase.
742523|NCT01034631||
742524|NCT01034592||
742525|NCT01034579||Of the 758 participants randomized and treated in study 24735 (NCT00078338), 326 were enrolled in EMR200136_023 (NCT01034579) out of which 2 participants, who had participated in initial pharmacogenetics (PGx) sub-study, were found to be ineligible and therefore, evaluable population for EMR200136_023 (NCT01034579) comprised of 324 participants.
742526|NCT01034553||
742527|NCT01034540|Recruitment was conducted using the research clinic database and print advertisements. First subject screened in May 2010 and screening ended in August 2010.|
742528|NCT01034527|School team recruitment|
742529|NCT01034462|Patient were recruited over a 21-month period from December of 2009 to September of 2011 at 23 studies sites in the United States.|Patients went through a 1-week single-blind placebo run-in period immediately preceding an 8-week double-blind treatment period.
742530|NCT01034397||
742531|NCT01034358|Between March 2010 and January 2011, female patients between age 12-25 years of age were recruited through the Inflammatory Bowel Disease Clinics at the Mayo Clinic.|
742532|NCT01034306||
742533|NCT01034176||
742534|NCT01034163|Participants were randomized in a 2:1 ratio to the PAN and placebo groups, respectively.|
742535|NCT01034137|A total of 360 participants were screened at 21 centers in the Netherlands from 04 JAN 2010 to 30 JUL 2012.|Of 360 participants, 43 failed screening.
742536|NCT01034111||
742537|NCT01033942|This research was conducted at two clinical sites in Chicago. Accrual was open between August 2009 and May 2011.|Young males were approached for screening in the community. If eligible, a clinic-based screening was done to confirm eligibility. If confirmed, participants attended a behavioral intervention. Then a week 0 was scheduled for randomization. 68 participants were enrolled; 10 discontinued prior to randomization, for a total of 58 participants.
742538|NCT01033864||
742539|NCT01033851|Participants were recruited by media advertisement and referral between December 2008 and February 2011.|
742540|NCT01033825||
742541|NCT01033773||
745268|NCT00889512||
742542|NCT01033747|This 5 year extension study includes participants treated in one or more studies: a 1 year main study to evaluate the safety,tolerability and the effects of 2 doses of deferasirox on liver iron content in comparison to standard chelation therapy with DFO, a 3 week food effect sub-study and a 12-21 month prolongation phase(NCT00379483).|
742543|NCT01033734||A total of 2836 participants were prescreened, of which, 2828 failed evaluation. The most common reasons for screen failure included: negative influenza diagnosis, not meeting the age criterion, ability to tolerate/absorb oral medication, and an inability to comply with the study procedures.
742544|NCT01033565|Only one subject was recruited who met criteria to participate.|One subject enrolled and finished participation.
742545|NCT01033487||
742546|NCT01033448|Participants from Study NCT01429792 with genotype 1 Chronic Hepatitis C (CHC) and were 'Slow Responders' were eligible to enroll in this treatment extension study. Participants from Study NCT01429792 with genotype 2 and 3 CHC and were non-Rapid Virologic Response (RVR) were eligible to enroll in this treatment extension study.|A total of 59 participants were enrolled in the study and 47 of them completed the study.
742547|NCT01033422||
742548|NCT01033383|Recruitment of participants occurred at 11 nursing homes from December 2009 to December 2010.|Once participants consented, they needed to be able to provide a clean catch urine specimen in order to be enrolled.
742549|NCT01033227|Subjects were recruited for the study during regular clinic visits.|Once consent signed subjects would not be randomized into the treatment arm until (if or when) they had their admission to the hospital for vaso-occlusive crisis (VOC).
742550|NCT01033136|A total of 93 participants were recruited for the study. Of these participants, 68 met study inclusion criteria and were included in data analyses.|
742551|NCT01033071|Participants enrolled at 130 investigative sites in Canada and the United States from 08 December 2009 to 04 November 2010.|Participants with essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
742552|NCT01033032|Patients were recruited at multiple dose levels into the Dose Escalation (Phase I) portion of this study to determine the safest dose of this regime (MTD - Maximum Tolerated Dose). Upon determination of this dose, patients being treated at the MTD proceeded to the Dose Expansion (Phase II) portion of the study and additional patients were recruited|
742553|NCT01033019|Twenty-five participants were enrolled into the trial. However, one participant was excluded from the efficacy analysis. Therefore, the enrollment number differs from the number started below.|
742554|NCT01032993|Persons with a history of statin myalgia were recruited from the greater Boston area using flyers, ads, and announcements to seek volunteers. A history of statin myalgia was defined as having muscle symptoms thought to be due to a statin, with symptoms that began after a statin was started and that persisted for at least 2 weeks while using statin.|Confirmation of statin myalgia was based on completing a statin washout, and statin rechallenge. On washout, improvement of symptoms within 2 months was required to advance. On rechallenge, simvastatin 20 mg daily was given, and only those with return of symptoms within 3 months were randomized. Out of 68 participants enrolled, 39 were randomized.
742555|NCT01032954||
742556|NCT01032928|Participants were recruited from the Head and Neck Clinics at the Ralph H Johnson Veterans Administration Medical Center and the Medical University of South Carolina between May 2010 and April 2013|87 participants were recruited; 67 completed screening; 32 were eligible for enrollment; 2 declined participation
742557|NCT01032915|Between February 2010 and March 2011, 125 patients were randomized from 51 centers in 9 countries (United States, Germany, Switzerland, India, Spain, United Kingdom, Israel, Brazil and Italy). Recruitment did not reach the target of 340 patients due to early termination of the study.|
742558|NCT01032889|This study was conducted at 10 centers in the United States.|
742559|NCT01032850||56 participants were screened. 39 did not meet criteria; 2 refused study entry. 15 participants were enrolled.
742560|NCT01032837||
742561|NCT01032759|77 participants signed consent, 63 participants were randomized|
742562|NCT01032733|Participants were recruited between September 2006 - December 2008 through a variety of methods including media articles, direct mailings, newspaper announcements, and presentations to community groups.|Following telephone screening, potentially eligible persons were invited to attend a screening visit during which the purposes and procedures of the study were explained and informed consent was obtained.
742563|NCT01032694||
742564|NCT01032629||No Text enterred
742565|NCT01032603||
742566|NCT01032538|All recruited from Martina Hansens Hospitals patients|
742567|NCT01032382||
742568|NCT01032330||Aside from the two primary cohorts (older and younger), there were 52 patients in a separate exploratory cohort of patients who had little or no stereoacuity (800 or Nil); this cohort is not being reported based on the criteria listed in the protocol.
742569|NCT01032291||Phase 2b Proof of Concept was designed to enroll 82 participants, however the study terminated early. Forty-three participants were enrolled, however, one was randomized to receive single agent lenalidomide but never received study drug and was excluded from the ITT and Safety populations.
742570|NCT01032265|Online recruitment via the project´s open access website, Dec 2009 - Oct 2010. Interested women answered an online survey for screening of the eligibility criteria. If eligible they were sent a postal questionnaire, including a 2-day bladder diary. Finally, to confirm the clinical diagnosis all women were interviewed by telephone by a urotherapist.|Randomisation was through a pre-specified computer-generated list, in blocks of eight. An independent administrator kept the list and consecutively allocated eligible participants to one of the two intervention groups. There was no blinding of group allocation to study participants, health care providers, or researchers.
742571|NCT01032239||A total of 61 patients were enrolled. One patient did not meet the inclusion criteria (screening failure). 60 patients were then randomized into the study.
742572|NCT01032200||
742573|NCT01032174||
742574|NCT01032135||All participants were enrolled when they entered IOP treatment. We collected baseline measures and monitored their treatment attendance. At 2 weeks, we determined whether they were engaged or nonengaged and randomized all participants at that time. Only those that were nonengaged at week 2 and still nonengaged at week 8 were rerandomized at week 8.
742575|NCT01032070||
742576|NCT01032044||
745269|NCT00889421||
742577|NCT01032018|Participants were recruited from sites connected with 5 field centers from March 18, 2010, to January 9, 2012. To be eligible, participants had to demonstrate elevated depressive symptoms on the BDI 2 to 6 months after hospitalization for an ACS.|724 patients were medically eligible for participation in the study, of which 150 consented to randomization and were enrolled.
742578|NCT01031979||
742579|NCT01031953|Participants were recruited from August 2008 until January 2013|There were 34 participants who signed the informed consent for this study but of these, only 11 received the study treatment. The other 23 were screen failures.
742580|NCT01031914|Participants were recruited from the general population, the sleep clinic at Sleep HealthCenters, Only subjects who had a diagnostic polysomnography and who were CPAP for at least 2 weeks, were considered for inclusion. Informed consent were be obtained by an investigator or research coordinator and was required for enrollment into the study.|N/A All participants enrolled in the trial have completed the study
742581|NCT01031836|This study was conducted at 7 centres in Japan. The first patient was enrolled on 25 November 2009 and the last enrolled patient had completed Stage II on 11 July 2016.|Thirty (30) patients received MEDI-545 either IV or SC treatment (5 patients in each cohort) at Stage I. Twenty-six (26) patients completed Stage I treatment and, out of these 26 patients, 21 patients were registered to continue in Stage II.
742582|NCT01031810||
742583|NCT01031706||
742584|NCT01031680|First participant enrolled: 10 Feb 2010, last participant for last visit for the 24-week period: 26 May 2011. This study was conducted in 4 European countries, 2 countries in Asia/the Pacific Region, The United States, Canada, and Argentina. In total 1429 participants were enrolled and 922 participants were randomized.|During a placebo lead-in period, participants were counselled on dietary and life-style modifications.
742585|NCT01031628||
742586|NCT01031550|Subjects will be randomized in two strata, those with and without preexisting liver disease. Subjects will be screened in pre admission testing|Subjects may withdraw consent
742587|NCT01031537||2 subjects withdrew after the screening visit and elected not re-enroll. 1 subject was a study screen failure.
742588|NCT01031498|Recruitment Period: 9/13/2005 to 9/22/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.|Of the 150 enrolled, only 143 patients were evaluable. Two patients were transferred to intensive care unit, two patients did not receive chemotherapy. One patient received one dose and was placed on hold. One patient received two antiemetic drugs; and 1 patient had a severe headache after two doses and was withdrawn.
742589|NCT01031446|This study opened to accrual in October 2009 and ran to June 2011.|Fifty-seven patients consented for this study, two were determined ineligible to participate.
742590|NCT01031420||
742591|NCT01031381||
742592|NCT01031134||
742593|NCT01031095||
742594|NCT01031069|"A number of 873 subjects were enrolled, out of which 173 subjects were excluded from all statistical analysis.
~154 subjects were not administered any vaccine dose (146 screen failures subjects and 8 subjects that did not participate from Visit 1)."|Screening involved: checking of inclusion/exclusion criteria, demographic data, history and physical examination, AF B sputum test and/or chest X-ray, blood sampling for HIV testing and safety, urine pregnancy testing, birth control and HIV, STI, STD counselling, checking records for concomitant medication/vaccination, subject card distribution.
742595|NCT01031043|Adult volunteers with a diagnosis of Esophageal Dysmotility were recruited from the senior author's clinical practice.|
742596|NCT01031004||
742597|NCT01030965||The study consisted of a Run-in Period of 5 to 8 days, followed by a 28-day Treatment Period. A total of 421 participants were screened; of these, 125 were screen failures, 10 were Run-in failures, 288 were randomized, and 285 received at least one dose of study drug (three participants were randomized but did not receive study drug).
742598|NCT01030952||
742599|NCT01030861||
742600|NCT01030822||
742601|NCT01030783||
742602|NCT01030757|8 subjects were screened; 6 did not meet entry criteria. 2 subjects were enrolled|
742603|NCT01030718|CA180-031 = NCT00337454; CA180-036 = NCT01030718|55 participants were randomized to study CA180-031; 1 participant with chronic myelogenous leukemia-chronic phase (CML-CP) was withdrawn prior to dosing due to thrombocytopenia. 54 subjects were treated; 44 subjects finished the study period of CA180-031 and transferred CA180-036. Analyses were done on the population enrolled into CA180-031 study.
742604|NCT01030666|From April 2007 to February 2009 all patients undergoing periodontal treatment at the Dept. of Periodontology, JWGUniversity Frankfurt and the Section of Periodontology, Department of Conservative Dentistry, University Hospital Heidelberg were screened for this study.|
742605|NCT01030653|Clinical research unit, subjects recruited over a 6 month period|This was a healthy volunteer study that did not require any pre assignment study procedures. 10 participants were consented but 8 were sufficient to complete the study. The remaining two subjects were not assigned to any arm, comparable to a screen failure. No intervention other than consent and screening occurred for these two subjects.
742606|NCT01030536|Study was started on 15 Feb 2010 and was terminated on 12 Sep 2012. The Product Development Team authorized early termination of this study due to prioritization of resources and the need to prioritize allocation of investigational product across the studies in the moxetumomab pasudotox clinical development program.|A total of 30 participants were screened and enrolled, of them 7 were failed screening. Twenty three participants were enrolled and assigned to treatment at 6 sites in the United States.
742607|NCT01030523||
742608|NCT01030458||
742609|NCT01030406||
742610|NCT01030341|Forty-five patients (age 18-70 years) with diabetes for >2 years in poor glycemic control (HbA1c >8%) with gastroparesis were recruited from 7 centers of the GpCRC from February 2012 through May 2014. Patients had symptoms for >1 year with Gastroparesis Cardinal Symptom Index (GCSI) scores of ≥18.|"Screening Phase-Baseline glycemic profiles were obtained with blinded sensors to acquire >216 hours of glycemic data over 2 weeks.
~Run-In Phase:Participants received detailed instructions in operating the CSII device and had to demonstrate competency in CSII and CGM and electronic CGM data transfer to be enrolled."
742611|NCT01030289||
742612|NCT01030198||
742613|NCT01030133||
745270|NCT00889330||
742614|NCT01029925|Patients with breast cancer (1) and non-small cell lung cancer (6) were recruited at UCLA between January 2010 and December 2010.|One patient developed a brain metastasis before beginning therapy and had to be excluded, and two patients were undergoing screening procedures when the study was placed on voluntary hold.
742615|NCT01029912||
742616|NCT01029886||
742617|NCT01029795||
742618|NCT01029782|Patients were included if they presented to the ED with presumed diagnosis of mild-moderate SSTI and were deemed well enough to be treated as outpatients and be able to return to the ED daily.|
742619|NCT01029730||
742620|NCT01029704||
742621|NCT01029691|Pregnant women with hypertension were recruited from University of Michigan obstetric clinics and inpatient areas. Enrollment into the trial occurred between March 2010 and November 2013.|After signing consent, one participant decided not to have any sleep studies performed, explaining the difference between the 125 enrolled listed in the registration section and the 124 followed below.
742622|NCT01029652||Two patients randomized to canakinumab did not receive any study medication and were discontinued from the core study on the day of randomization, with the reason for discontinuation listed as Administrative Problems.
742623|NCT01029587||
742624|NCT01029535||
742625|NCT01029405||
742626|NCT01029392||Blood vitamin D level checked to assign to treatment or no-treatment arm
742627|NCT01029366|Study Start/End Dates 17-Mar-2010 to 06-Jul-2015|
742628|NCT01029340|Participants were recruited from specialized hemophilia treatment centers.|14 participants were enrolled in each of Arms 1 and 2 in Part A. Of these, 11 participants continued into each of Arms 3 and 4 in Part B. Arm 3 enrolled 20 and Arm 4 enrolled 21 additional participants who had not participated in Part A. Arm 5 enrolled 5 participants specifically for surgery in Part C who had not participated in Parts A or B.
742629|NCT01029262|239 participants were randomized at sites located in Europe (185), North America (24), Asia/Pacific (13) and the Middle East (17).|Participants must have had transfusion-dependent anemia defined as having an average transfusion need of at least 2 units of packed red blood cells (pRBCs) per 28 days during the 112 days preceding randomization; No consecutive 56-day period that was RBC-transfusion-free during the 112 days preceding randomization; hemoglobin levels ≤ 9.5 g/dL.
742630|NCT01029054||
742631|NCT01028937||
742632|NCT01028911|Participants who were on a stable dose of donepezil (Aricept) 10 milligram (mg) once daily for at least 30 days before screening and on stable morning dosing at least 14 days before Day 0 were enrolled in this study.|
742633|NCT01028820|We planned to recruit participants through the NDRC Registry and Division TEACCH, as well as utilizing radio and television ads on various stations. We also posted brochures and flyers in public locations and attended conferences in order to hand out study-specific information. 13 subjects began the study and only one of those failed to complete.|In order to participate in the research study, subjects must have been washed out from psychoactive medication for at least one month for fluoxetine, two weeks for other SSRIs and neuroleptics and five days for stimulants prior to MRI scanning, with the exception of stable doses greater than three months duration of medication for seizure disorder.
742634|NCT01028677||
742635|NCT01028651||
742636|NCT01028560|58 children were recruited from one tertiary treatment center, Jacobi Medical Center, which is the largest city hospital in the Bronx, New York. The referral population consists of primarily low-income, Medicaid beneficiaries residing in the Bronx.|There was no run-in phase. After consents were signed (by the parents), the 58 participants were immediately randomized into treatment or control group. 8 of the 58 participants were withdrawn from the study immediately after randomization, so only 50 participants began protocol treatment.
742637|NCT01028391|"First patient in the 30-week extension study: 21-Sep-2007.
~Last patient last visit of the 30-week extension
~study: 23-Jan-2009; 53 study centers worldwide."|"Patients ≥18 years with type 2 diabetes mellitus (T2DM) and hemoglobin A1c (HbA1c) of 8-12% on diet/exercise meeting all other entry criteria were eligible for participation in the 24-week base study.
~Patients who completed the base study with >75% study drug compliance were eligible to enter the 30-week extension study at participating sites."
742638|NCT01028378||
742639|NCT01028352|Between December 2008 and May 2010 35 subjects enrolled and completed baseline questionnaires in the University of Michigan comprehensive cancer center's outpatient hematolgy / oncology clinic|
742640|NCT01028300||
742641|NCT01028222||
742642|NCT01028131||
742643|NCT01028053||
742644|NCT01028027|This study was conducted at seven sites, by seven Investigators in the People's Republic of China. First participant was enrolled 10/21/2009 and last participant visit was 2/9/2010.|A total of 357 participants with clinically diagnosed blepharokeratoconjunctivitis (BKC) in at least one eye were enrolled. 328 participants completed the study.
742645|NCT01028014|Healthy women,ages 19-51 and up including pre-menopausal older women who have had a normal menstrual cycle for the prior 3 months.Participants were recruited via local newspaper. The first participant was enrolled 5/27/10. Recruitment ended August 31, 2010|
742646|NCT01027910||
742647|NCT01027897|Patients recruited from April 2010 to July 2011. All patients were admitted to the Surgical ICU during the study period|
742648|NCT01027884|Recruiting centres were in Belgium, Germany, the Netherlands, Switzerland, France, Sweden, Austria, Italy, Spain, and the USA. Patients were enrolled between July 27, 2009 (study start date), and Dec 14, 2012; the study end date (last patient completed the study) was Jan 14, 2014.|65 patients were randomly assigned and two patients were allocated to the same treatment as their randomly assigned siblings. One patient never took study medication, resulting in 66 patients who were treated and included in the safety population (34 in the placebo group and 32 in the idebenone group).
742649|NCT01027871||
742650|NCT01027845|A total of 360 subjects were enrolled in the study. All subjects received at least one vaccination dose.|
742651|NCT01027819|Recruitment was started from Sep 2005 to Aug 2006 in medical clinic and randomly allocated into two groups.|
742652|NCT01027806||
742697|NCT01025336||Only participants who completed Parent Study 6115A1-3010 (NCT00574548) or Parent Study 6115A1-3005 (NCT00546572) were enrolled in this follow-up study 6115A1-3018 (NCT01025336).
742653|NCT01027780|Between March 2006 and August 2009, women and men ages 65 and older were recruited from the community via advertisements in local newspapers and from University of Rochester Strong Health-associated primary care offices using flyers. Exclusion criteria were utilized as indicated in the protocol section.|
742654|NCT01027754||
742655|NCT01027702|Patients who received a CD34+ selected peripheral blood stem cell (PBSC) transplant on the companion study, LCH BMT 09-01, at Levine Children's Hospital between December 2009 and June 2016.|Subjects were enrolled to two cohorts based on donor type, Mismatched Related Donor (MMRD) and Matched Unrelated Donor (MUD).
742656|NCT01027650||Doses for Stage 2 were selected based on the safety and pharmacodynamic results from Stage 1. No patients in Stage 1 were enrolled in Stage 2.
742657|NCT01027598||
742658|NCT01027559||Prior to being assigned to a group, 6 depressed participants dropped from the study before being assigned to treatment type.
742659|NCT01027468|Medical University of Vienna, Department of Ophthalmology during September 2008-July 2009 with a mean of 3 year follow-up after initial Bevacizumab intravitreal treatment|"Inclusion criteria:
~patients treated with bevacizumab due to wet age-related macular degeneration
~follow-up of 3 years
~Exclusion criteria:
~- patients with other macular diseases"
742660|NCT01027416||
742661|NCT01027364||
742662|NCT01027351|Subjects were enrolled from 1 center in the United Kingdom.|All subjects were included in the trial.
742663|NCT01027286||
742664|NCT01027273|Participants were enrolled from June 2009 to June 2012 recruited at community based sites as well as clinical sites.|
742665|NCT01027195||
742666|NCT01027000|Between February 2010 and January 2014, 68 participants were recruited.|
742667|NCT01026974|Subjects were recruited from a single center.|All enrolled subjects were included in the trial.
742668|NCT01026948||
742669|NCT01026909||
742670|NCT01026844|Twenty-seven patients were enrolled between August 2007 and May 2010. They were all patients at Mass General Hospital Cancer Center|
742671|NCT01026831||
742672|NCT01026818||The study consisted of a 6-week screening period including the time of bilateral nerve-sparing radical prostatectomy (BNSRP) surgery, a 9-month, randomized Double-Blind (DB), Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label (OL) Period.
742673|NCT01026805|An unselected series of eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator at four hospital or ambulatory surgical center sites were assessed for this study.|
742674|NCT01026792||
742675|NCT01026623||
742676|NCT01026493||
742677|NCT01026454|HSV-2/HIV-1 dually-infected participants were recruited between March and November 2010 from Thika, Kenya.|66 participants screened; 34 excluded (33 did not meet inclusion criteria, 1 declined study participation); 32 enrolled
742678|NCT01026402|First Subject In: 30th December 2009 Last Subject Last visit: 18th August 2014 2 sites located in the UK Number of participants analyzed in Dose Limiting Toxicity (DLT) outcome measure are patients evaluable for DLT assessment Note - in the Clinical Study Report, combined groups are discussed (e.g. Part A 125mg BD Int and Part B 125mg BD tab Int)|A total of 172 patients were enrolled. 135 of these patients passed screening assessments and were dosed
742679|NCT01026389|Recruitment period between october 2009 and January 2011. Patients were recruited in hospitals.|3 patients were not randomized: 2 patients because of technical issue and one patient because of sponsor decision (inclusion period finished/ number of evaluable patients achieved)
742680|NCT01026324|Subjects were screened and enrolled at one site in the US, Dana Farber Cancer Institute.|
742681|NCT01026220||
742682|NCT01026194||
742683|NCT01026181||
742684|NCT01026142|452 participants were randomized to one of two treatment arms: trastuzumab and capecitabine (Arm A, 224 participants) or pertuzumab with trastuzumab and capecitabine (Arm B, 228 participants). Of participants randomized to Arm A: trastuzumab and capecitabine, 6 participants did not receive study treatment.|
742685|NCT01026103||thirty patients consented, 1 was excluded by physician for elevated liver function test; 1 was not considered enrolled as subject did not receive study device in error, leaving 28 enrolled subjects.
742686|NCT01026038||A total of 263 participants who had received a 4-dose vaccination series of pneumococcal conjugate vaccine as part of study 6096A1-008 (NCT00366678) were enrolled for this study. Out of those 1 participant was a screen failure and was not included in results.
742687|NCT01026012|recruitment period January 2010 to October 2010 occurred in outpatient office.|
742688|NCT01025843|A Part II of this study was planned. However, since the efficacy criteria for advancing to Part II were not met in Part I, this study was considered completed with the completion of Part I. Therefore participants were not recruited for Part II.|
742689|NCT01025830|Subjects were recruited from an ongoing cohort study in Kampala, Uganda. The first subject was recruited in Feb 2006.|Participants received a medical and laboratory examination before assignment. Subjects were excluded if they had active tuberculosis or were anemic. 22 participants were recruited; 22 were screened,2 were excluded (1 did not meet inclusion criteria and 1 refused participation).
742690|NCT01025817|"In total 738 participants were screened, and 613 were transplanted and randomized to treatment (n=309 to EVR+Low TAC dose and n=304 to MMF+Std TAC).
~EVR=Everolimus and low dose tacrolimus, and MMF=Mycophenolate mofetil and standard dose tacrolimus."|
742691|NCT01025791|Participants were recruited at 2 clinical study sites in Germany and in Belgium.|For Panel A, 5 treatment periods were planned in this study. For Panels B and C, only 4 treatment periods were planned.
742692|NCT01025752|Veterans with chronic back pain from VA Connecticut Healthcare System and surrounding community areas were recruited from June 2012-July 2015.|Eligibility screening was conducted by the research assistant via interview and medical record review. Participants who enrolled then subsequently found ineligible from further baseline assessment questionnaires were not randomized to a treatment arm, and excluded from the study (i.e. substance abuse, severe depression, cognitive impairment), n=9.
742693|NCT01025635||
742694|NCT01025492||The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team, therefore it is not known to which arm/group each of the participants enrolled.
742701|NCT01025193|From April 2010 to October 2011 patients listed for renal transplant at the Hospital of the University of Pennsylvania who met study inclusion criteria and none of the exclusion criteria were approached during an outpatient clinic visit to participate in the study.|There were no wash out, run-in or transition periods for this trial.
742702|NCT01025154|Recruitment Period 1/28/2010 - 2/20/2013; All participants were registered at The University of Texas MD Anderson Cancer Center.|Of the 63 participants registered, four (4) were excluded prior to study starting.
742703|NCT01025076||
742704|NCT01025037||
742705|NCT01024972|All patients with aSAH were screened for eligibility between 10/2009 and 10/2012. Inclusion criteria were aSAH ≥18 years, aneurysm fully secured by coiling or clipping, Hunt&Hess grade <5, modified Fisher Scale >1, ALT, AST, AlkPhos <3x upper limit of normal, serum Na (sNa) ≥135mmol/L and no mannitol or hypertonic saline prior to drug infusion.|Routine patient management: All aSAH patients were treated according to our institutional protocol following published aSAH critical care guidelines, including admission to our closed neuroscience intensive care unit (neuroICU) with board-certified neurointensivist as the primary attending.
742706|NCT01024959|507 male subjects were recruited from 14 clinical sites in the United States including academic institutions, community-based urology clinics and group health organizations.|
742707|NCT01024946||
742708|NCT01024920|An open-label, 2:1 randomised, open-label, parallel-arm comparison of nintedanib versus sunitinib. in patients with advanced renal cell cancer (RCC) who had not received prior systemic therapy|All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
742709|NCT01024855|Recruitment of employees occurred 7/8/2010 - 10/1/2010 thru employee bulletin for study taking place at in-house optometric clinic.|"Prior to baseline visit subjects were instructed to undergo a washout period where no contacts were worn for 12 hours. Slit lamp exam was conducted prior to randomized group assignment. Eyes were thoroughly rinsed with unit-dose aline before pre-soaked study lenses were inserted."
742710|NCT01024751|This one month study was conducted at 20 sites by 20 investigators in the United States. First participant was enrolled 11/30/2009 and last Participants visit was 1/22/2010.|312 participants(624 eyes) started the study, 7 of which were ineligible at baseline, one was non-dispensed. 305(610 eyes) participants were eligible. 3 participants were discontinued during the study. 302 participants (604 eyes) completed the study.
742711|NCT01024738|Performed at the clinic|
742712|NCT01024686||
742713|NCT01024608|A total of 484 patients were screened and 463 patients were enrolled in the study and participated in the Run-in Period. Of the 463 enrolled patients, 340 were randomized to study treatment.|During the 7 to 10 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their seasonal rhinitis symptoms twice daily to determine eligibility for randomization.
742714|NCT01024569||
742715|NCT01024465||
742716|NCT01024387|Patients enrolled from June 2010 through June 2011.|
742717|NCT01024335||
742718|NCT01024309|66 volunteer participants were enrolled during routine clinical practice of the principal investigator between the dates of 12/8/2009 and 10/9/2012.|12 patients withdrew participation prior to randomization
742719|NCT01024296||
742720|NCT01024244||
742721|NCT01024036|79 participants were enrolled at 38 study centers in 19 countries. The first participant signed the informed consent on 09 Feb 2010, and the last participant's last visit for the primary analysis was 28 Feb 2013. The data until the end of study is presented here.|79 participants were enrolled, randomized and treated during the blinded treatment period. 53 received siltuximab+best supportive care (BSC) and 26 received placebo+BSC.13 participants who did not respond to placebo+BSC during the blinded treatment period, received siltuximab+BSC during the unblinded treatment period.
742722|NCT01024010||
742723|NCT01023958||An open-label, single-arm, Phase II trial of intravenous volasertib (BI 6727) in patients with locally advanced, metastatic or recurrent urothelial cancer of the bladder, renal pelvis, or ureters after failure of prior chemotherapy.
742724|NCT01023841||
742725|NCT01023815|A total of 332 patients were screened. 330 were pre-randomized, 2 were not. Additionally, 2 pts were not treated which made the safety/ITT population 328. Of the 328, 184 were randomized and 144 were not. Of the 144, 70 dropped before day 90 & 74 completed the pre-rand period but were not randomized because they were not eligible for randomization.|During the Pre-randomization Period all patients received the same treatments. At V5 eligible patients were randomized 1:1:1 to one of the treatment arms and entered the Randomized Treatment Period. After Amendment 1 approval, randomization to once-a-day regimen group was stopped and patients were randomized 1:1 to Group B or Group C.
742726|NCT01023789|A total of 812 subjects (Intent-to-treat population) have been registered in 25 countries across the globe in compliance with the study Clinical Investigation Plan (CIP).|Out of the 812 subjects registered, a total of 43 subjects discontinued the study due to death (n=29) , withdrawal of consent (n=1) and lost-to-follow-up or missed the final 3 year follow-up visit (n=13).
742727|NCT01023776|Healthy Volunteers were recruited from the general public between December 2009 and January 2010|28 volunteers were recruited; 20 were enrolled and received at least 1 dose of vaccine, 8 were excluded (2 refused further participation and 6 did not meet inclusion criteria #2)
742728|NCT01023724||
742729|NCT01023711|Subjects were recruited via flyers and advertisments. Recruitment began 12/2009 and ended 10/2010. Subjects were screened via IRB approved Screening script by phone and visit as indicated.|Subjects 18-32 were required to have a serum antibody test done during screening. Their HAI antibody level needed to be less than or = to 1:8. Female subjects of childbearing potential must have a negative pregnancy test at screening.
742730|NCT01023672|Subjects were enrolled at the Mayo Clinic in Rochester, Minnesota|
742731|NCT01023659|Participants visited the study website, provided consent and completed an on-line assessment. Eligible participants received a personalized script to take to their physician, who could prescribe varenicline or bupropion for 12 weeks, or neither.|
742732|NCT01023620||No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.
742733|NCT01023581|Participants took part in the study at 198 investigative sites worldwide from 16 November 2009 to 30 June 2011.|Participants with a diagnosis of type 2 diabetes and glycemia inadequately controlled on diet and exercise alone were randomly assigned with equal probability to 1 of 7 treatment groups, including placebo, alogliptin alone, metformin alone or a combination of alogliptin and metformin.
742734|NCT01023568||
742735|NCT01023516|First patient enrolled 24 November 2009. Last patient completed 18 August 2010. Study conducted at 79 centres in 6 countries (Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia).|3- or 4-week run-in period on budesonide/formoterol twice daily to stabilise patients on maintenance therapy before randomisation. Patients already on budesonide/formoterol required a 3-week run-in period and patients on ICS as monotherapy or in combination with any long-acting bronchodilator required a 4-week run-in period.
742736|NCT01023308||
742737|NCT01023269||17 patients were included in the study: 9 patients did not pass the test stimulation period, 1 patient dropped out due to exclusion criteria, 1 patient dropped out due to protocol deviation during screening visit, 1 patient dropped out before test stimulation due to early termination of the study, leaving 5 patients who were randomized.
742738|NCT01023256|Subjects were recruited and screened between January 19, 2010 and February 9, 2012 at rheumatology centers in Europe (Bulgaria, Germany, the Netherlands, Poland and Ukraine).|Subject eligibility was determined at the screening visit (up to 35 days before treatment initiation) and confirmed at baseline before the first dose on day 1.
742739|NCT01023217||
742740|NCT01023178|from 2007-2011 study participants were recruited from pediatric endocrinology clinics at Lucile Packard Children's Hospital at Stanford.|
742741|NCT01023074||
742742|NCT01023061||
742743|NCT01023035||687 Participants enrolled and were treated with Peginterferon/Ribavirin (PEG2b/RBV) followed by PEG2b/RBV + boceprevir. 500 participants became anemic during treatment and were randomized to either the RBV Dose Reduction Arm (n=249) or the Erythropoietin Use Arm (n=251).
742744|NCT01023022||
742745|NCT01022996||
742746|NCT01022853|An uncontrolled, open-label, dose escalation study in cohorts of patients following the '3+3 design with de-escalation'. After entering the study, cohorts of patients were sequentially allocated to the dose levels.|Beginning after the first cycle of treatment, intra-patient dose escalations were allowed and could be repeated after every cycle. Intra-patient dose escalation was not allowed after the maximum tolerated dose (MTD) was determined.
742747|NCT01022762|The trial was conducted at 23 sites in China.|Between screening and treatment with trial drug the participants were assessed for eligibility and were randomised to one of two treatment arms. A sub-group of 69 participants was recruited for intravenous glucose tolerance test and randomised into the repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants)
742748|NCT01022567||
742749|NCT01022502|Participants recruited from ambulatory department of Chang Gung Memorial Hospital,in northern Taiwan between November 2009 and May 2010.|41 participants recruited and screened,3 exclude ( 2 did not meet the eligibility criteria and 1 refuesed to participate).
742750|NCT01022424||
742751|NCT01022398||
742752|NCT01022307||
742753|NCT01022242||
742754|NCT01022203||Twenty-four subjects (12 couples) were lost or withdrew from the study after providing consent and participating in the pretreatment assessment, but before randomization to one of the two treatment conditions (Structured Approach Therapy or PTSD Family Education).
742755|NCT01022190|All subjects have been recruited|No participants were excluded
742756|NCT01022112||
742757|NCT01022073|The original study CSP #468 visits were completed in October 2008, and the kick-off meeting for the follow-up study was held on April 26-28, 2010. Out of the total randomized 299 participants in the main study of CSP#468, 156 participants enrolled in this follow-up study. Subject recruitment started in August 2010 and ended in September 2011.|This is follow-up study from the original study CSP#468.
742758|NCT01021956||
742759|NCT01021878||
742760|NCT01021852||326 participants were randomized in this study into one of 8 treatment sequences. Participants received double-blind study drug in Treatment Period (TP)1, followed by a washout period (3 day single-blind placebo plus 11 day drug holiday), and then double-blind study drug in TP2.
742761|NCT01021813||Of the 781 participants randomized into the Treatment Phase, 522 were randomized to suvorexant and 259 were randomized to placebo. Two participants were randomized, but not treated (one from each treatment group); therefore, the total number of participants evaluated for safety was 779.
742762|NCT01021761||
742763|NCT01021748||
742764|NCT01021683||
742765|NCT01021618|Recruitment took place in the Hartford Hospital Nuclear Cardiology Laboratory from January 2010 and February 2012.|At the onset of the study, only subjects with scores greater than or equal to 9.95 were randomized. After the first 96 patients had been screened and 55 randomized with no adverse events in the study group, this restriction was removed.
742766|NCT01021553|The study was conducted at 6 sites in United States and 2 centers in the Netherlands during 23 December 2009 to 05 May 2011.|The study consisted of 4 weeks run-in period. Total 77 male participants with primary pre-mature ejaculation were enrolled and randomized. Out of these 65 participants completed the study.
742767|NCT01021423||Randomization was stratified according to 1) the type of first-line induction chemotherapy (anthracycline-based, fludarabine-based, or rituximab-bendamustine combination therapy) and 2) the response to first-line induction chemotherapy (complete response or partial response).
742768|NCT01021332|Participants were eligible for Study 905-CL-057 if they completed 12 weeks of double-blind treatment in Study 905-CL-055, complied with inclusion criteria and did not meet any exclusion criteria. Participants treated with the FDC 0.4 mg/6 mg or 0.4 mg/9 mg for maximally 40 weeks.|All eligible participants started with 4 weeks of open-label FDC 0.4 mg/6 mg and were given the opportunity to adjust their dose at 3 monthly intervals thereafter if desired.
742769|NCT01021306||
742873|NCT01015131||After enrollment, 2 of the 46 participants discontinued due to lack of available 3'-deoxy-3'[18F]-fluorothymidine (18-FLT), leaving 44 participants as the baseline population.
742874|NCT01015118||1366 patients were randomised for this study.
742770|NCT01021293|Of the 1101 enrolled subjects, one subject was not randomised and administered any vaccine as the parents of the subject refused to vaccinate their child after blood collection at Visit 1 and withdrew their consent.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
742771|NCT01021215|Recruitment Period: May 5, 2010 to September 12, 2011. All recruitment done in medical clinics at Weill Cornell Medical College (WCMC), a Participating Organization within the MD Anderson Cancer Center (MDACC) Consortium.|A total of 84 subjects were enrolled, four withdrew for different reasons before beginning study medication leaving 80 subjects started on the study medication(s).
742772|NCT01021137|140 Veterans were recruited for this study. Participants included Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans and healthy, age & gender matched controls. Veteran participants had a history of traumatic brain injury (TBI), blast exposure, or both.|Six participants were consented to participate in the study, but did not return to complete the protocol. Case history was not collected and therefore, the participants could not be assigned to any of the study groups.
742773|NCT01021111|Participants were involved in sports involving jumping maneuvers at the recreational level and free of previous lower limb musculoskeletal injuries, surgery, or pain. Subjects were unaware of the goals of the study prior to the start of the testing session.|
742774|NCT01021020|Twenty-eight (28) healthy, non-smoking, adult male and female volunteers, consisting of university students and members of the community at large, were to be enrolled.|75 subjects screened, 47 were screen failures
742775|NCT01021007|At clinical site|
742776|NCT01020981|Interview and focus group participants and survey pre-testers participated during drill weekends in November and December 2010. Surveys were mailed to MI NG members in March 2011 with 2nd mailing in April 2011, and 3rd mailing in May 2011 and to Indiana NG members with first mailing in Sept 2011 , 2nd in Oct 2011, and 3rd mailing in Nov 2011.|Fifteen soldiers in Michigan participated in interviews or focus groups during survey development. The survey was fielded to 300 Soldiers, 150 in Michigan and 150 in Indiana. A total of 141 Soldiers either returned a survey and/or completed an interview and were considered enrolled in the study. This is detailed in Participant Flow.
742777|NCT01020903||
742778|NCT01020877||
742779|NCT01020838|Subjects were screened at 15 study centers in Australia, Germany, France, Japan, and the U.S.|
742780|NCT01020812||
742781|NCT01020799|A total of 18 centers were inititated with first patient enrolled on 16 November 2009 and last patient completed on 15 April 2010. A total of 430 patients were enrolled with 247 qualified patients allocated to randomized treatment.|Patients were required to discontinue current treatment for MDD at least 7 days prior to randomization (14 days prior to Day 1 for monoamine oxidase inhibitors [MAOIs] and 28 days prior to Day 1 for fluoxetine). Patients not taking medications for MDD at enrollment could be randomized once eligibility was confirmed.
742782|NCT01020786||"Induction period: pemetrexed and carboplatin were administered for 4 cycles (1 cycle=21 days). Participants with documented complete response (CR), partial response (PR), or stable disease (SD) entered the maintenance therapy period (fifth cycle and after).
~Maintenance period: pemetrexed monotherapy until a discontinuation criterion was met."
742783|NCT01020773||
742784|NCT01020747||
742785|NCT01020591|Thirty subjects between the age of 48 and 80 years with radiographic confirmed knee OA were recruited. All data collection took place at the School of Health Sciences Room 658 Bethune building on South park St in Halifax Nova Scotia between January and March of 2010.|
742786|NCT01020526|A total of 63 participants were screened and enrolled at 19 study centers in this open-label extension study to the parent double-blind randomized fibromyalgia study A0081180.|
742787|NCT01020474|A total of 147 participants were screened, 107 participants were randomized to treatment. The 107 randomized participants were recruited in 4 countries at 23 study centers.|This study consisted of 4 phases, screening (1 Week), dose optimization (3 Weeks), fixed dose (12 Weeks) and follow-up (1 Week).
742788|NCT01020448|Study Initiation Date: 30-Nov-2009. Subjects screened were 339 and screen failures were 13.|
742789|NCT01020435||
742790|NCT01020305||
742791|NCT01020123||
742792|NCT01020019|Participants were treated at the Substance Treatment and Research Service (STARS) of Columbia University/ New York State Psychiatric Institute (NYSPI). Study enrollment occurred from January 2010 through May 2014 with study completion in September 2014.|The study included a one-week placebo lead-in phase. Participants were randomized at the end of the placebo lead-in phase and those who reported marijuana use less than once a week during the lead-in phase were considered placebo responders and were not randomized. A total of 34 participants discontinued prior to randomization for various reasons.
742793|NCT01020006||
742794|NCT01019980|2 participants entered the study but did not receive drug because drug was not available in the region. The study was then terminated.|
742795|NCT01019928|"A total of 30 patients were enrolled, 16 of these patients were NOT randomized for the following reasons:
~Voluntary discontinuation by patient = 3 Incorrect enrollment (did not meet inclusion/excl criteria) = 13"|14 patients were randomised, 1 patient received placebo in the first treatment period without any events, but had an SAE prior to receiving AZD1386 in the second period and was withdrawn. 13 randomised patients completed the study, but one of these patients was incorrectly enrolled and excluded from the per-protocol analysis set.
742796|NCT01019707|Potential subjects will be self-identified as non-treatment seeking MA users recruited via advertisements in online sources and newspapers, on radio stations, and community locations, as well as through referrals from within as well as from outside organizations via flyers, and from past research participants.|MA-dependent, non-treatment seeking subjects only were enrolled in this study. A screening period to assess eligibility criteria was used to determine study eligibility. Study completion involved finishing a 15-day inpatient period,followed by 14+ days washout in community, followed by a second 9-day inpatient period.
742797|NCT01019694||
742875|NCT01014988||Male or female participants who were >=6 months of age, hospitalized with laboratory-confirmed influenza, and able to receive study drug within 7 days of influenza symptom onset were enrolled in the study.
742876|NCT01014975||
742877|NCT01014936||First/last subject (informed consent): November 2009/December 2014. Last subject completed: October 2015. Clinical data cut-off: February 2016
742798|NCT01019486|Recruitment began 7-22-2010 and ended 12-30-2011. We recruited from subjects of the Coronary Artery Calcification in Type 1 (CACTI) Diabetes Study (R01HL61753) included type 1 diabetic patients (duration, diabetes 10 yrs) and non-diabetic controls (spouses or friends of these diabetic patients, focusing on individuals completing 6-yr follow-up..|Twenty-five subjects planned with 26 consented with one excluded with significant renal disease. A total of 25 myocardial perfusion imaging studies; 23 MRI myocardial blood flow (MBF) MRI studies performed of which 23 yielded analyzable. A total of 3 subject meet criteria to proceed to invasive coronary flow reserve measurements
742799|NCT01019369||
742800|NCT01019317|Recruitment Period: 11/23/2009 through 10/25/2010. All participants recruited at UT MD Anderson Cancer Center.|Of the 151 participants enrolled, four (4) participants were excluded from the trial before treatment.
742801|NCT01019252|Participants were recruited through passive methods (e.g., local radio advertising, flyers, social media), active outreach (e.g., mailing through the Research Patient Data Registry), and physician referrals.|66 adolescents completed baseline eligibility procedures. 2 opted-out of treatment due to logistical constraints.18 were excluded pre-randomization: 6 exclusionary psychiatric comorbidity, 5 clinician-rated severity below threshold, for 4 ADHD not primary diagnosis, and 2 not taking ADHD medication, 1 had a medical condition that would interfere.
742802|NCT01019135||
742803|NCT01018992|Participants were recruited from Emory University School of Medicine, Mount Sinai School of Medicine, Baylor College of Medicine, and the University of California San Francisco between January 2010 and June 2014.|Subjects stopped psychotropic medications (w/ the exception of zolpidem, eszopiclone, and zaleplon for insomnia) w/in 2 weeks (6 weeks for fluoxetine) of Visit 1. Patients on ineffective psychotropic medications tapered off by the patients' prescribing doctor. 139 subjects did not proceed to randomization due to meeting exclusionary criteria.
742804|NCT01018979||A total of 20 subjects were randomized. Among these, 19 subjects met all eligibility criteria and received at least one dose of TG-0054.
742805|NCT01018953|This study was terminated prematurely. Only 8 patients were treated in part A and no patients participated in part B.|Patients screened were 15 and not treated were 7 (2 subjects were not included due to early termination of study by sponsor and 5 subjects failed to meet inclusion criteria).
742806|NCT01018862||
742807|NCT01018810||
742808|NCT01018732|Participants were enrolled at 3 centers in the USA|All subjects enrolled were included in the trial.
742809|NCT01018680||
742810|NCT01020487|Part 1 was an open-label, single-dose study evaluating the pharmacokinetics of paricalcitol capsules in children with moderate to severe chronic kidney disease (CKD). Part 2 consisted of a double-blind, placebo-controlled study to evaluate safety and efficacy of paricalcitol and an open-label phase where all participants received paricalcitol.|Two participants enrolled in Part 2 after completing Part 1 of the study, hence the actual total number of enrolled participants is equal to 47.
742811|NCT01018511||Prior to randomization, participants entered a single-blind placebo run-in period for 2 weeks and completed a 3-day micturition diary. After the placebo run-in period, participants' eligibility criteria were re-confirmed and the participants were then randomized into the double-blind treatment period of the study.
742812|NCT01018420|Eighteen (18) healthy, non-smoking, adult male and female volunteers, consisting of university students and members of the community at large, were to be enrolled.|50 subjects screened, 28 were screen failures, 4 were alternates
742813|NCT01018394|Recruitment began on February 2010 and completed on September 2011. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, Minnesota and Oregon Research Institute in Eugene, Oregon) for consenting and additional study procedures to determine eligibility.|
742814|NCT01018264||
742815|NCT01018186|Participants were randomized in a 2:2:1 ratio to Fluticasone Furoate/GW642444 Inhalation Powder (two strengths: 200/25 micrograms (µg) once daily and 100/25 µg once daily) and fluticasone propionate 500 µg twice daily, respectively.|Participants meeting all inclusion criteria and none of the exclusion criteria during the screening visit entered a 2-week Run-in Period for completion of Baseline safety evaluations and to obtain Baseline measures of asthma status. At Visit 2, participants were randomized to a 52-week Double-blind Treatment Period.
742816|NCT01018134||
742817|NCT01018095|HIV-infected women undergoing a routine gynecological examination performed by a clinic health care provider between May 1, 2006 and July 17, 2009 were tested for Trichomonas Vaginalis (TV) by culture as standard of care practice in selected public HIV outpatient clinics in New Orleans, Louisiana; Houston, Texas; and Jackson, Mississippi.|
742818|NCT01018056|Consent will be obtained by Dr. Harvey Singer from eligible patients at the Tourette Syndrome Clinic in the JHH Outpatient Center. Patients will be given a general synopsis of the research study and carefully explained each page of the consent form. Once informed consent is obtained, the subject will be considered to have entered the study.|39 patients were enrolled at a screening visit, but for a variety of reasons (i.e. no longer interested, concerned about blood draws, medication use, et cetera) only 30 started medications at the baseline visit. Of these 30, 24 completed the study.
742819|NCT01018030|Participants were randomized to a double-blind, placebo-controlled, parallel-group, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray 110 micrograms (either once or twice daily) for the treatment of uncomplicated acute rhinosinusitis in adults and adolescent participants 12 years of age and older.|
742820|NCT01017952||At Visit (V) 1, eligible participants (par.) entered a 4-week, open-label Run-in Period (RIP) to establish a stable Baseline. At V 2, eligible par. were randomized to a 52-week, double-blind Treatment Period. 2635 par. were screened, 2092 par. entered the RIP, and 1635 par. were randomized, out of which 1633 par. received >=1 study treatment dose.
742821|NCT01017874||Participants who died or continued on study but discontinued receiving study drug were considered to be completed.
742822|NCT01017731||68 participants signed the informed consent.
742823|NCT01017653||
742988|NCT01009463||At Visit (V) 1, eligible participants (par.) entered a 4-week, open-label Run-In Period (RIP) to establish a stable Baseline. At V 2, eligible par. were randomized to a 52 week, double-blind Treatment Period. 2631 par. were screened, 2071 par. entered the RIP, and 1626 par. were randomized, out of which 1622 received at >= 1 study treatment dose.
742989|NCT01009346|Early Termination.|Early Termination
742990|NCT01009333||
742824|NCT01017601|One-hundred twenty-one (121) participants were pre-registered and 59 participants were registered between January 2010 and January 2013. Study was terminated prematurely on 1/10/2013 due to an interim analysis that declared futility. No additional clinical and survival follow-up data are required as of 11/15/2014.|Sixty-two participants were deemed screen failures: 26 progression, 21 did not meet eligibility criteria, 6 patient decision and 9 other reason. Out of the 59 randomized participants, there were 8 cancellations and one participant was found to be ineligible upon audit. All seventy-one participants mentioned above were excluded from all analyses.
742825|NCT01017575|The study was conducted at 6 sites in Japan.|A total of 55 participants were enrolled, of which 43 participants were randomized and 42 were treated. 12 participants were not randomized because 10 no longer met study criteria and 2 withdrew consent; 1 randomized participant was not treated due enlarged lymph node.
742826|NCT01017549|Hospitals with radiation oncology departments who had acquired the Xoft Axxent system and were qualified to be in the study were chosen as the 10 sites. Breast surgeons and radiation oncologists were the site investigators at 10 sites.|This was a single arm study, no randomization. Some patients consented but fell out of the study due to not meeting all eligibility (I/E) criteria after consenting to participation. 61 patients provided consent, 44 were treated.
742827|NCT01017536||
742828|NCT01017497||
742829|NCT01017263|Potential participants are pre-screened at the Duke Obesity Clinic. Eligible participants then come to the Duke ADHD Clinic for their first study visit.|At the screening visit, psychiatric evaluation and fasting labs were obtained to determine eligibility. Of the 14 subjects only 2 qualified and received study drug. Reasons for screen fails: 8-did not meet lab parameters for glucose intolerance, 1-elevated BP, 1- elevated TSH, 1- doing well with current ADHD treatment, 1- diagnosed with depression.
742830|NCT01017250|Recruitment period Jan 2, 2010-Jan 12, 2011 Location: Radiation Oncology Clinic|
742831|NCT01017237|Patients requiring extraction of third molars requiring sedation in the Oral Surgery clinic recruited.|
742832|NCT01017146||
742833|NCT01017120||
742834|NCT01017042||
742835|NCT01017029||
742836|NCT01017003||
742837|NCT01016977||
742838|NCT01016964|This double-blind, device controlled 26 week study was recruited at 3 clinical study sites. The recruitment period was from February 1, 2010 to September 28, 2010|Key exclusion criteria was pregnancy, malignancy in target area, an no hair transplants, scalp reductions, or hair weaves. Active hair loss less than 12 months.
742839|NCT01016938||
742840|NCT01016912|The study was conducted at 6 sites in Japan.|A total of 51 participants were enrolled, of which 45 were randomized to receive treatment and 6 were discontinued for no longer meeting study criteria.
742841|NCT01016873||
742842|NCT01016847||38 subjects enrolled in study. Of the 38 subjects 10 were screen failures, and 25 were withdrawn during the 2 week run-in period.
742843|NCT01016834|Recruitment period occured from November, 2009 to February, 2010 at 22 US medical clinics|
742844|NCT01016769||
742845|NCT01016691||
742846|NCT01016678|The study recruitment period started in March 2010 and the last subject was exited March 2013. The 4 sites who recruited all patients, consisted of 2 private practices and 2 children's hospital based site.|104 patients were randomized and dispensed study drug but only 94 of those patients actually treated at least one migraine, so therefore 94 subjects data was used in the analysis.
742847|NCT01016652|This was a four week, 49 subject, doubly-masked, daily wear, two-part crossover study. Recruited patients were emerging presbyopic (35-47 years) and soft CL wearing who were experiencing any near vision symptoms.|A screening questionnaire (Near Vision Questionnaire, (NVQ)) was used to recruit subjects and to provide information about the wider population.
742848|NCT01016600||31 participants were enrolled but only 30 participants started treatment and completed treatment.
742849|NCT01016483|First/last subject (informed consent): Nov 2009/Jul 2013. Clinical data cut off: Dec 2013, Study completion date: April 2015|
742850|NCT01016353||
742851|NCT01016262||Out of a total 119 double-blind phase participants, 116 participants (including 9 of the 11 participants that terminated early) further continued in the open-label (OL) phase where, under the amended protocol versions 3 and 4, they were provided the opportunity to voluntarily receive MAX-002, standard care treatment, or no treatment
742852|NCT01016132||
742853|NCT01016106||
742854|NCT01016067||
742855|NCT01016015||
742856|NCT01015976||
742857|NCT01015833||
742858|NCT01015820||37 patients were enrolled in the study. Of these, 5 patients with neuroendocrine tumors and 2 patients with duodenal anatomy limiting the use of the probe were excluded because of screen failure.
742859|NCT01015807||
742860|NCT01015781||
742861|NCT01015768||Eyes were randomized to one of two conditions.
742862|NCT01015703||
742863|NCT01015677|Thirty sites in the United States, Canada, France, Belgium, New Zealand, and Australia received IRB/ERC approval. Of the 354 participants screened for inclusion, 255 participants were excluded during screening (235 participants did not meet specific exclusion criteria). Ninety-nine participants were randomized for the study.|The study was terminated at the end of Stage 1 so no participants entered Stage 2 and no participants received MK-6913 25 mg.
742864|NCT01015638|Clinical research center. Enrollment started: 11 Aug 2009 Last patient last visit: 1 Sep 2009|Subjects who met inclusion and exclusion criteria and are willing to participate in the study were required to undergo a 3-day screening period where they will stop the use of all facial products on their face. Subjects were required to use soap free cleanser for washing their face and may apply their normal makeup.
742865|NCT01015612||
742866|NCT01015586||
742867|NCT01015560||
742868|NCT01015534|Participants were recruited from patients from Instituto Nacional de Cancerología de México, from January 2006 to September 2008.|Seventy-two patients were assessed for eligibility. Twelve patients did not meet inclusion criteria. Five patients declined to participate. Fifty-five patients were enrolled.
743080|NCT01004705|126 subjects were screened, 47 met eligibility requirements and 44 entered the run-in period.|
742878|NCT01014910|Recruitment occurred from October 2009 to April 2014. Only 1 study site used an institutional clinical practice guideline during the study. Respiratory-distress scoring systems for hospitalized patients were not standardized across sites. All sites used an oxygen saturation level of 90% or higher in room air as a criterion for hospital discharge.|Participants were sequentially randomized at each site in strict chronological order of hospital admission each day. Screening of participants was performed on weekdays during normal business hours. only. Parents/guardians were blinded to allocation assignment until informed consent was obtained; study personnel and outcome assessors were not.
742879|NCT01014871|Recruitment process: patients from private practice - Recruitment period: First Patient In = 13 July 2009 Last Patient In = 09 November 2009 - Type of location: hospital|
742880|NCT01014767|PI left institution prior to completion of project. 27 cases are listed in linked abstracted. (Arm A=12, Arm B=1, Arm C=4, Arm D=1, Observation = 3 and Unknown=6) PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available.|PI left institution prior to completion of project. 27 cases are listed in linked abstracted. (Arm A=12, Arm B=1, Arm C=4, Arm D=1, Observation = 3 and Unknown=6) PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available.
742881|NCT01014741||
742882|NCT01014728||
742883|NCT01014689|Recruitment period 14/08/2009 to 21/01/2010 Type of location: hospital, private hospital and private practice.|
742884|NCT01014624|Subjects were recruited at 4 sites in the US from 23 February 2010 to 04 May 2010 and 56 subjects were randomized into the study. The study population consisted of male and female aspirin-treated subjects with stable coronary artery disease, 18 to 75 years of age.|Following a 1-day to 14-day Screening Period, eligible subjects were randomized in a 1:1 ratio to either prasugrel or clopidogrel at Visit 2 (the first day of the Active Treatment Period).
742885|NCT01014585|Recruitment period was from November 2009 through February 2010 at 58 centers in the United States with the last patient visit occurring on June 7, 2010.|Upon completion of a long term milnacipran open label study MLN-MD-06, patients were enrolled in the current study MLN-MD-27 (NCT01014585), and received open label treatment with milnacipran for four weeks prior to randomization.
742886|NCT01014533||
742887|NCT01014455|Cigarette smokers scheduled for elective non-cardiac surgery were recruited from the preoperative evaluation clinic at Mayo Clinic Rochester.|Inform consent was obtained after data collection(approved by the IRB) because informing patients of the study at time of enrollment would have required providing information making it impossible to evaluate the hypothesis. Study records from patients who declined informed consent (n=14) were destroyed and are not included in the analysis.
742888|NCT01014442||
742889|NCT01014390||
742890|NCT01014351||
742891|NCT01014208|Participants who were refractory to, or had relapsed following, first-line treatment with rituximab in combination with an anthracycline- or anthracenedione-containing chemotherapy regimen, and who were eligible for autologous stem cell transplant (ASCT), were eligible for enrollment.|Eligible participants were randomized to receive either rituximab or ofatumumab in addition to salvage chemotherapy.
742892|NCT01014169|Mothers on the postpartum ward of an urban safety-net hospital were recruited. Inclusion criteria included gestational age > 35 weeks, fluency in English or Spanish, and access to a telephone. Mothers were excluded if there was prolonged hospitalization of the mother or the infant or if they were not expected to retain custody of the infant.|
742893|NCT01014143|Recruitment was performed by the clinical site|
742894|NCT01014091||From a total of 60 subjects enrolled in the study only 58 were vaccinated.
742895|NCT01014013|"Patients were recruited from 9 Medical Centers of Korea between April 2008 and January 2009.
~Last patient has visited on 27 Feb 2009."|1 patient was excluded due to ineligibility. The patient had a positive at screening pregnancy test.
742896|NCT01013961|This study was activated on October 8, 2010 and closed on October 31, 2013 with a total of 31 patients accrued.|Peripheral blood (preferred) or bone marrow must be submitted at pre-registration for FISH risk analysis to determine stratification factor before randomization.
742897|NCT01013883|Patients referred to the one stop diagnostic heart failure clinic from Jan 2002 to Dec 2007, were followed up till Aug 2011.|
742898|NCT01013870||
742899|NCT01013844|Participants were recruited from hospital registries of patients who were diagnosed as having cutaneous melanoma (CM) and were being seen at least annually by physicians for their skin conditions.|
742900|NCT01013792||
742901|NCT01013753||
742902|NCT01013740||In the Randomized Phase (RP), participants were treated until disease progression (PD) or discontinuation of treatment due to unacceptable toxicity, withdrawal of consent, lost to follow-up, or death. After PD in the RP, participants were given the option of crossing over to the alternative treatment arm in a post-progression Cross-over Phase (CP).
742903|NCT01013701||The PI has left the institution and neither he, nor the data if any, is available. All information provided has been obtained from the Johns Hopkins University School of Medicine Institutional Review Board and was only available as one arm.
742904|NCT01013597||
742905|NCT01013350||Study enrolled participants from previous clinical trials (NCT00213135, NCT00436826, NCT00641537, NCT00938366 and NCT00725985) and were exposed either to placebo matched to cladribine or cladribine itself. 13 enrolled participants from NCT00938366 were excluded from safety analysis as the dose was relatively lower compared with other studies.
742906|NCT01013285|Seventy patients with newly diagnosed Glioblastoma Multiforme were enrolled between August 2006 and November 2008 from two participating sites, comprised of University of California, Los Angeles (UCLA) and Kaiser Permanente Los Angeles.|Control cohort was derived from University of California, Los Angeles/Kaiser Permanente Los Angeles patients treated with first-line radiation therapy and temozolomide who had mostly received bevacizumab at recurrence.
742907|NCT01013207|Participants recruited from ResMed Science Centre, Sydney, between November 2009 and March 2010|
742908|NCT01013194||
742909|NCT01012999|Over a 2 year period we recruited 16 patients who presented to a single Emergency Department.|
742910|NCT01012973||
743223|NCT00997113|34 patients were elligible, 14 underwent sedation emergently before the patient could be approached for study enrollment.|
743224|NCT00997035||
743225|NCT00996996||
742911|NCT01012947|The trial was conducted from August 2008 to December 2010 at a geriatric mental health community center in Suwon, south Korea. The center, which has been established since 2008 and has outreach sites throughout the districts, provides a range of social, health, educational, and recreational services for users of elderly groups.|Criteria for exclusion included severe visual or hearing impairment and a previous diagnosis of idiopathic Parkinson's disease, liver disease, alcoholism, or known terminal illness. Prior to initiating the study, we obtained a list of all senior citizen centers. A random number table was used to classify the intervention group.
742912|NCT01012921||
742913|NCT01012765||173 participants were screened. 129 participants entered the study.
742914|NCT01012739||
742915|NCT01012713||
742916|NCT01012674|First patient first visit: 28 Oct 2009. Last patient last visit: 12 Oct 2010. Location: radiology departments|A total of 211 patients fulfilling the eligibility criteria were enrolled, of which 187 patients received Dotarem and completed the study. Twenty-four patients did not receive Dotarem and were discontinued prematurely.
742917|NCT01012661||
742918|NCT01012622||
742919|NCT01012492||One patient signed consent but was determined to be an assignment failure prior to starting study activities.
742920|NCT01012440||
742921|NCT01012414|The enrollment period began in November 2009. The first subject was emrolled June 17, 2010. The final subject (#12) was enrolled April 14, 2011.|2 additional participants were in a washout period when the study was stopped. These participants were not enrolled or randomized.
742922|NCT01012388||
742923|NCT01012362||
742924|NCT01012336||
742925|NCT01012323||
742926|NCT01012297||
742927|NCT01012258||A total of 70 participants were screened, out of which 4 participants were not treated and 66 participants received the study treatment.
742928|NCT01012245|Open-label, prospective, multi-center, non-interventional cohort study (NIS) at 385 centers (office-based ophthalmologists); number of subjects per center was not limited.|Subjects were assigned to a therapeutic strategy within current practice and not according to a protocol.
742929|NCT01012219||
742930|NCT01012167||"Consented/Screened for Study-- N=86
~Withdrew prior to randomization (N=28)
~2 withdrew consent
~26 did not meet inclusion criteria
~Randomized-- N=58"
742931|NCT01012089||
742932|NCT01012037||
742933|NCT01011946||
742934|NCT01011933|The study initially opened 9/8/2009 and enrolled 28 participants. It was suspended on 5/17/2010 and re-opened 5/2/2011, enrolling an additional 26 participants until it was closed on 10/24/2011.|
742935|NCT01011907||99 subjects were consented of which 64 successfully completed the screening process were randomized to treatment. Results are posted for the 35 subjects who completed the study.
742936|NCT01011894|Protocol Open to Accrual 11/6/2009, Protocol Closed to Accrual 2/26/2013, Primary Completion Date 2/23/2016, Recruitment location is the medical clinic|
742937|NCT01011868||
742938|NCT01011829|Twenty treatment-seeking adults with current methamphetamine (MA) dependence were recruited through advertisements in newspapers, the internet, radio and community outreach from Nov 2009 to Feb 2010.|All potential subjects were consented and then completed study screening measures over a max. of six study visits in order to determine study eligibility. Subjects had to be over 18 years old, MA dependent, and looking for treatment with no Axis I disorder not related to substance abuse and have no contraindications for use of varenicline.
742939|NCT01011816||
742940|NCT01011738|A total of 1842 participants were enrolled at 219 centers across 26 countries from 10 April 2009 to 17 November 2014.|
742941|NCT01011673|Patients were recruited from one emergency department (ED) in the Bronx, NY|
742942|NCT01011634||
742943|NCT01011556||
742944|NCT01011465|Participants were enrolled in this study from 6/2008 to 4/2012. Initial screening was done by phone and email. Medical screening took place at a hospital clinic and the rest of the study took place at the Harvard School of Public Health.|After initial screening , participants were asked to sign consent form and screened in a medical clinic prior to group assignment. Participants were excluded for violating study criteria, including having BMI>30, high blood pressure, acute illness, smoking or drug use and chronic medical conditions. Refusal to sign consent also led to exclusion.
742945|NCT01011439|Subjects were enrolled from 22 February 2010 to 05 April 2016|
742946|NCT01011413|38 clinical centres (primary and tertiary care facilities) in 13 countries on 5 continents screened a total of 768 patents who had provided informed consent between Aug 4, 2011 and March 19, 2012.|768 screened:132 did not satisfy eligibility: 2 prior AIDS-defining illness; 3 previous antiretroviral therapy; 15 HIV RNA out of range; 44 cluster of differentiation (CD)4 count out of range; 13 lab values out of range; 2 pregnant; 9 intercurrent illness; 2 illicit substance use; 30 exceeded screen time; 4 clinician exclusion; 9 withdrew consent.
742947|NCT01011387|Investigation period: Feb 2010 - July 2010. In- and/or out-patients at two centers in UK were included in this investigation. Subjects included were 18 years and above with DFU including post amputation wounds associated with diabetes.Dressing changes were made 3 times/week for maximum 4 weeks.|
742948|NCT01011335|Eligible subjects were recruited from two clinical sites: San Antonio Military Medical Center, San Antonio, TX and Naval Medical Center, Portsmouth, VA between August 2010 and February 2011.|Subjects who consented to the study but who were not randomized were those who either failed screening due to abnormal baseline laboratory results, or who met screening criteria but became ineligible to receive a study injection or were unavailable at the time of injection. Subjects who were unavailable at the time of injection were replaced.
742949|NCT01011309|Patients with CL were actively recruited from Andean mountain regions endemic for transmission of Leishmania peruviana. Patients were treated in a medical clinic at the Instituto de Medicina Tropical 'Alexander von Humboldt', Universidad Peruana Cayetano Heredia, Lima, Peru.|All eligible patients were randomized to treatment groups. One patient was mistakenly randomized (ineligible) and was not treated.
742950|NCT01011283|This study was recruited at 20 centers in U.S. during the period of Feb 2010 to Jan 2011.|
742951|NCT01011218||
742952|NCT01011179|Participants were recruited from 4 pediatric, rheumatology clinics located within tertiary care centers across Canada. Adolescent participants were recruited between October and November 2008.|
742953|NCT01011153|Physicians were selected from the membership list of the AAD and lists provided by SK&A Healthcare Information Solutions. A letter was then sent inviting them to participate. For each who replied positively,an access code was mailed with which to log on to the study. 241 subjects logged into system,183 signed consents & completed the Intake Survey.|Participants were grouped according to responses to an Intake Survey, completed after Consent and before reading any study cases. A maximum of 130 cases were reviewed,each one consisting of 3 clinical images and a case history. MelaFind results were not provided as part of each case and were only used for sensitivity and specificity calculations.
742954|NCT01011075|Subject screening for this study began effective 08/12/2009 at the UNM Cancer Center. Recruitment was conducted through the outpatient clinic. Patients were recruited until 04/30/2010.|
742955|NCT01011049|Participants were enrolled and from 23 September 2009 to 16 October 2009 in 46 medical centers in the US.|A total of 1248 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
742956|NCT01010984||
742957|NCT01010971||
742958|NCT01010932|First patient first visit: 21 Sep 2009. Last patient last visit: 18 Nov 2010. Location: radiology departments|A total of 222 patients fulfilling the eligibility criteria were enrolled, of which 200 patients received Dotarem and completed the study. Twenty-two patients did not receive Dotarem and were discontinued prematurely.
742959|NCT01010906||
742960|NCT01010867||
742961|NCT01010854||
742962|NCT01010776||
742963|NCT01010763|Period of Recruitment was from December 2009 until December 2011. Recruitements were done at medical clinics by providing detailed explanation of procedure as well as study protocol, including randomization & right of withdrawal.|Four patients withdrer before randomization.
742964|NCT01010750||Each of the 3 treatment regimens was administered daily for 7 days (a total of 21 days of treatment). There was no washout between regimens.
742965|NCT01010633|This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.|406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.
742966|NCT01010568||
742967|NCT01010555|Four participants were enrolled but not dispensed due to failing inclusion/exclusion criteria (2) and withdrawing consent (2). These participants are included in the Actual Enrollment and Baseline Characteristics calculations, but not Participant Flow.|This reporting group includes all enrolled and dispensed participants.
742968|NCT01010503||
742969|NCT01010477|141 subjects screened. Of these 66 were consented. Eleven were later found to be ineligible and were dropped prior to randomization. Fifty five subjects were randomized to active or placebo NNS. Three subjects were found to be not eligible after randomization leaving 52 for analysis.|
742970|NCT01010399||
742971|NCT01010282||
742972|NCT01010230|81 participants enrolled 05/2010-10/2012. Each was: treated for childhood cancer, 5+ years from diagnosis, lumbar or whole body BMD z-scores of < -1.0, not currently being treated for cancer, 7-17 years, able to stand 10 min., tolerated calcium and vitamin-D supplements. Those with untreated endocrine disorders and pregnant females were excluded.|Fifteen participants were deemed ineligible after baseline testing, 11 because their bone density z-scores were > -1.0, one because they were on an oral steroid, one was older than the maximum age limit and two had unstable endocrine status. Two additional participants consented, but withdrew prior to baseline testing.
742973|NCT01010217|Patients were enrolled during the period from January 2010 through August 2014 and were assigned to the HAPLO arm or the 9/10 MUD arm based on donor availability and physician preference. The 3 arms received identical melphalan-based conditioning chemotherapy and GVHD prophylaxis|Additional arm elderly patients did not accrue any participants so therefore was excluded from summary.
742974|NCT01010204||
742975|NCT01010126||
742976|NCT01010061|787 patients were enrolled in the study. Following a 6 patient safety run-in prior to randomization, 781 patients were randomized.|589 patients were randomized to 1 of 3 treatment groups in 2:2:1 ratio: GClb (n=238), RClb (n=233) or Clb (n=118) in Stage 1 and an additional 192 randomized to GClb or RClb in Stage 2 [NCT02053610]. Stage 1 was divided for analysis into: Stage 1a (GClb vs Clb) n=356 reported here and Stage 1b (RClb vs Clb) [NCT01998880] reported separately.
742977|NCT01010009||
742978|NCT01009983||
742979|NCT01009931||
742980|NCT01009840||
742981|NCT01009814|This was a randomized, open label, multiple-dose study to evaluate the pharmacodynamics, safety and pharmacokinetics of BMS-663068 in human immunodeficiency virus 1 (HIV-1) infected participants. The study was conducted at single center in Germany.|A total of 75 participants were screened, of which 25 were screen failure, and 50 eligible participants were enrolled into the study and were randomized.
742982|NCT01009762|Participants were recruited at the infectious disease department at the University hospitals|20 participant numbers were randomised to vaccine or placebo but at the deadline for expiring of the vaccine only 11 participants were enrolled but all 11 completed the study
742983|NCT01009645|Eligible participants had scheduled appointments in a private medical clinic during October 2009 - March 2010. Potential participants were sent an opt-out letter indicating that they would be receiving a phone call to invite them to participate in a study if interested; those not opting out were contacted and asked to participate.|"If potential participants had already received the seasonal influenza vaccination for 2009 - 2010 or responded on the phone that they definitely intended to receive the vaccine, they were excluded from the study. These screening questions were asked prior to enrollment into the study."
742984|NCT01009619||
742985|NCT01009580|"The trial was conducted at 50 sites in 10 countries: Australia (5 sites), Denmark (7 sites), Finland (5 sites), India (9 sites), Malaysia (3 sites), Poland (5 sites), Sweden (6 sites), Taiwan (3 sites), Thailand (3 sites), Turkey (4 sites).
~In addition, 1 site in Thailand screened but did not randomise any subjects."|Between screening and randomisation, eligible subjects were to continue their usual pre-trial oral anti-diabetic drug (OAD) of metformin, pioglitazone and DPP-4 inhibitor.
742986|NCT01009554||
742987|NCT01009515|Subjects were recruited from sites in the New Mexico Cancer Care Alliance from October, 2009 to March, 2013.|
742991|NCT01009294|A total of 11 participants with nonsense mutation Duchenne/Becker muscular dystrophy (nmDBMD) and were nonambulatory signed the informed consent form and were screened for eligibility. Six of these participants were enrolled at 2 sites. Three of the participants were receiving chronic corticosteroid therapy.|When the Sponsor terminated the study, the participants were told to discontinue ataluren treatment, and to return all unused ataluren to the site for return to the Sponsor. Because of difficulty of traveling to the clinic for these nonambulatory participants, the planned final visits were not performed.
742992|NCT01009203|Dates of recruitment period: December, 2009 - March, 2011|
742993|NCT01009138||
742994|NCT01009099|Patients were recruited from a midwestern VA hospital and were also referred from other patients and private practices.|204 patients signed informed consents and were screened for participation in the study. 85 patients did not meet eligibility criteria for the following reasons: PFT results did not meet study criteria, claudication, cardiac issues, non-compliance, changed their mind, and active substance use. 119 patients were enrolled in the protocol.
742995|NCT01009086||
742996|NCT01009060|The study was conducted at 14 centers in the United States from 1 December 2009 to 10 August 2011. Study included d-amphetamine therapeutic challenge (dropped in amendment 2), treatment period of 7 weeks (4 weeks titration and 3 weeks of maintenance) and follow up visit approximately 7-10 days following their last dose of study medication.|A total of 118 participants (par.) were screened. Out of these 50 participants were randomized. Out of these, safety population consisted of 50 participants and intent-to-treat (ITT) population consisted of 46 participants.
742997|NCT01009047||
742998|NCT01009034||
742999|NCT01008995||
743000|NCT01008969||
743001|NCT01008943||
743002|NCT01008904|We enrolled female patients with bothersome hot flashes (defined by their occurrence ≥14 times per week and of sufficient severity to make the patient desire therapeutic intervention for ≥ 1 month prior to study entry) after undergoing treatment for cancer. Patients were recruited from the Massey Cancer Center oncology clinics.|Of the 31 patients enrolled, 29 received treatment. 25 completed treatment and were analyzed.
743003|NCT01008748|Recruitment Period: September 2009 and September 2016. Participants were recruited from the Mexican-American Cohort study and from Houston area.|
743004|NCT01008722|Recruitment from medical clinic.|Recruitment from medical clinic.
743005|NCT01008696||Out of 225 participants consented, 217 were assigned to the study medication.
743006|NCT01008618||
743007|NCT01008605||
743008|NCT01008553||
743009|NCT01008475||This study consists of two parts, safety part and randomized part. A total of 16 subjects were included in the safety part and 216 subjects were included in the randomized part of the study. The subjects who participated in the safety part of the study were not included in the randomized part of the study.
743010|NCT01008462||
743011|NCT01008449||
743012|NCT01008423||
743013|NCT01008410||
743014|NCT01008319|Recruitment was in the infertility clinic.|
743015|NCT01008280||
743016|NCT01008150||
743017|NCT01008059||
743018|NCT01007916||One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
743019|NCT01007942|DCO ( Data cut-off) for patient disposition is 1-Apr-2015. Each Cycle = 21 days|284 patients randomized to the Everolimus + trastuzumab + vinorelbine arm, 280 took drug. 285 patients randomized to the placebo + trastuzumab + vinorelbine arm, 282 too drug. A total of 569 were comprised to randomized total and 562 to safety.
743020|NCT01007838|Chronic kidney patients were recruited from local renal units. Healthy controls were recruited from the North Wales Community. Recruitment period was from January 2009 to July 2011.|
743021|NCT01007812||
743022|NCT01007656|Thirty-one (31) healthy adult subjects enrolled the study. The study period was a continuous 90-day. Each subject received GD Antrodia Camphorata (as three 500 mg capsules) at 7:30 and 19:30 for continuous 90- day.|One participant didn't continue on the trial by his own will.
743023|NCT01007643|22 females between 11-17 yrs. of age with untreated patellofemoral syndrome recruited from a pediatric sport medicine clinic from October 2009 to June 2010.|
743024|NCT01007591||
743025|NCT01007552||
743026|NCT01007526|Recruitment between August 2008 and October 2010 Location: University hospital or Institutes|
743027|NCT01007448||Participants were randomized in a 1:1 ratio to bexarotene 150 milligrams (mg)/square meter (m^2)/day or 300 mg/m^2/day.
743028|NCT01007435||Five of 1162 randomized patients (2 placebo to tocilizumab + methotrexate, 2 tocilizumab 4 mg/kg + methotrexate, 1 tocilizumab 8 mg/kg + methotrexate) did not receive any study treatment and were excluded from all analysis populations.
743029|NCT01007396|The study participants were doctors and nurses who were newly hired in 2008 at the Samsung Medical Center, a 2,000-bed referral hospital in Seoul, Korea.|
743030|NCT01007253|Healthy patients age 18-50 completed an allergy questionnaire and underwent skin puncture testing for confirmation of allergy to grass or ragweed. Female subjects were given pregnancy tests. Patients who were eligible then underwent a screening nasal challenge with either grass or ragweed allergen depending on their skin test results and history.|After a 2-week washout period, 21 subjects who had positive screening challenge returned to the Nasal Physiology Laboratory where they were randomized to receive one of four treatment orderings in this four-way crossover study.
743031|NCT01007149||79 patients were screened. 41 patients received study medication.
743032|NCT01007136|UT SOuthwestern Hospitals, rehabilitation and stroke clinics were screened for eligible stroke patients from 2009 through 2014.|Enrolled participants were assigned to groups unless they were found to meet one of the exclusion criteria, or withdrew their consent.
743033|NCT01007123||
743034|NCT01007110||
743035|NCT01007071|Subjects were recruited from the neuroendocrine center at Stanford Hospital|All patients were naïve to study drug, per protocol and eligibility criteria. Therefore, no washouts or other required delays were part of the study.
743036|NCT01007032||Participants who had progressive disease (PD) were considered to complete the study.
743037|NCT01006980||675 participants were randomized, 337 to vemurafenib and 338 to dacarbazine. One participant randomized to dacarbazine was treated in error with vemurafenib throughout the study and is included in the Vemurafenib arm in the table below and for exposure and safety analyses and is included in the dacarbazine arm for efficacy analyses.
743038|NCT01006967||
743039|NCT01006889|24 subjects recruited at the ALMVA hospital and University Hospital starting in 2006|24 participants signed informed consent, however only 20 started the study.
743040|NCT01006707||
743041|NCT01006655|Participants recruited from Pediatric pulmonology out clinic, Rambam Medical Center, Haifa, Israel between March 2009 and January 2010|40 participants approached, 23 agreed and have been screened, 2 excluded (1 adenosine challenge test negative, 1 obstructive respiratory impairment)
743042|NCT01006629|Subjects were enrolled into the study in 3 geographic areas of the Russian Federation. Recruitment began in November 2009 and ended in December 2009. Subjects at high risk of severe RSV infection (including preterm infants, infants with BPD, and infants with HSCHD) were identified as candidates for the study on the basis of routine assessments.|
743043|NCT01006616||
743044|NCT01006603|In total, 152 study centres in 13 countries recruited patients in this study. The first patient was enrolled in the study on 20 October 2009, and the last patient completed the study on 14 June 2012. 957 subjects were enrolled. 753 were deemed eligible for lead-in and 720 were randomized.|A 2-week single-blind (to patient only) placebo lead-in period occurred from Week -2 to Week 0. Patients were from this period on,counselled on dietary and lifestyle modifications according to usual clinical routine. They were given a glucometer to check their plasma glucose at home at least every second day.
743045|NCT01006590|The study was conducted at hospital clinics and general practitioners. Patient recruitment started October 20, 2009 and was completed April 30, 2010|Screening, enrollment (2 weeks) and lead-in period (4 weeks). Main reason for not being randomised was due to renal function not meeting inclusion criteria. (Samples taken and analysed after enrollment into the study but prior to randomisation).
743046|NCT01006538||
743047|NCT01006356||
743048|NCT01006291|The trial was conducted at 69 sites in 14 countries: Hungary (3 sites), Macedonia (1 site), Serbia (3 sites), Finland (7 sites), Norway (6 sites), United Kingdom (6 sites), Argentina (4 sites), Mexico (2 sites), South Africa (3 sites), India (10 sites), Malaysia (5 sites), Taiwan (3 sites), Russian Federation (8 sites) and Israel (8 sites).|
743049|NCT01006252||
743050|NCT01006135||Whilst 4854 patients were enrolled in the study, only 4852 of these entered and were included in the treated set, since two patients had no evidence of Spiriva administration.
743051|NCT01006122||
743052|NCT01006018|"Only 3 control (normal glucose tolerance) subjects were enrolled to obtain results in normal subjects for the hyperglycemic clamp (without GLP-1 or arginine). No samples were run, and, therefore, there are no data for the control subjects.
~No subjects with impaired glucose tolerance (IGT) were recruited or enrolled in the study."|
743053|NCT01005966|Participants were recruited at the clinical site.|83 participants were screened and 18 participants did not meet the study criteria thus 65 participants were enrolled into the study. The subjects were randomized to receive all 5 study treatments in a pre-determined computerized randomised order as per a typical cross-over design.
743054|NCT01005914||
743055|NCT01005901||1324 participants were screened. 822 participants entered the study.
743056|NCT01005888||A total of 26 subjects were enrolled in the study (see Detailed Description). One subject received open-label C1 esterase inhibitor (C1INH-nf) but withdrew prior to randomization. Another subject was randomized but withdrew prior to receiving study drug. 24 subjects were randomized and began therapy with blinded study drug in Period 1.
743057|NCT01005875||
743058|NCT01005810||
743059|NCT01005745|Participants were recruited at Moffitt Cancer Center from October 20, 2009 until November 15, 2012.|
743060|NCT01005732|During the 12-year period from 1995 to 2007, in accord with the Human Subjects Division of the University of Washington, 67 consecutive patients were enrolled. Thirteen patients exited the study prior to any data collection. Eleven of these chose to remove themselves, one was lost to follow-up and the reason was not recorded for one patient.|
743061|NCT01005719||
743062|NCT01005706||
743063|NCT01005680||
743064|NCT01005602||
743065|NCT01005576|Participants were recruited based on physician referral at 11 academic medical centers. The first participant was enrolled in May 2010 and the last participant was enrolled in April 2012.|
743066|NCT01005459|Participants were approached after admission to the labor and delivery unit of our hospital about participation in this study|
743067|NCT01005407||
743068|NCT01005355||A participant was considered to have completed the study if he or she completed the initial 6-week treatment period (Cycle 1) or if he or she discontinued therapy because of an IMC-1121B (ramucirumab)-related toxicity during Cycle 1.
743069|NCT01005329||
743070|NCT01005316||
743071|NCT01005290|Ninety-four subjects were screened for eligibility, participants met eligibility requirements and entered the run-in period|52 subjects enrered the run-in period with ramipril 2.5 mg, 38 subjects were randomized. 20 subjects were randomized to Sequence Combination pill/ Ramipril and 18 subjects to sequence Ramipril /Combination pill.
743072|NCT01005251||
743073|NCT01004991||
743074|NCT01004939||
743075|NCT01004874||
743076|NCT01004861|The dose escalation phase administered ascending daily oral doses of PLX3397 to patients with solid tumors and evaluated PK and toxicity. Once the recommended phase 2 dose was reached, 6 extension cohorts were enrolled, consisting of a variety of tumor types.|At least 3 participants and up to 6 participants were to be enrolled in each dose level using 100% dose increments for each level in the absence of Grade 2 or greater drug-attributable toxicity. Dose escalation was only permitted if adequate safety and tolerability were observed at the previous lower dose for 28 days for the first 3 participants.
743077|NCT01004848||
743078|NCT01004822||This study was planned to be conducted in 2 stages, however, no participant could reach out to Stage 2 due to discontinuations of all the participants in Stage 1.
743079|NCT01004770||
743081|NCT01004614|Participants were screened at one center in Japan.|This study consisted of 2 cohorts (I and II). The design of each cohort was an open-label, randomized, 2-periods, crossover, single-dose study in healthy adult male subjects. A washout period of at least 14 days was taken between each administration in Periods 1 and 2.
743082|NCT01004510||
743083|NCT01004432||
743084|NCT01004406|Subject recruitment for Phase I pilot study started on September 6, 2011, and the first participant was randomized on September 8, 2011. The recruitment period stopped in June 2012. For 2 participating sites, Dallas and Oklahoma City randomized 26 and 5 participants, respectively.|There were 59 subjects consented and enrolled into the study before entering catheterization lab to have the PCI procedure, but 28 subjects were not randomized to treatment assignments with the major exclusion reasons as not referred for PCI or not able to comply with study protocol based on the inclusion/exclusion criteria.
743085|NCT01004393||
743086|NCT01004354||
743087|NCT01004263||A total of 674 patients met inclusion/exclusion criteria and were allocated study drug. Of these, 606 were treated with study drug.
743088|NCT01004250||The study had 3 periods: a baseline period; a study treatment period, including both induction (Ind) and maintenance (Maint) treatment; and a follow-up period.
743089|NCT01004185|Screening began on 6 Oct 2009|There was a 30-day run-in phase for subjects continuing directly from Study 2007017.
743090|NCT01004172|Participants were recruited between November 2009 and August 2012.|
743091|NCT01004159||
743092|NCT01004146||
743093|NCT01004107||
743094|NCT01004003||
743095|NCT01003990|710 participants were enrolled, 709 were treated. The participant who did not receive treatment was enrolled in error having been assigned to efavirenz in the parent study AI424034 (only subjects assigned to ATV rolled over into AI424077).|
743096|NCT01003938|From Oct 2009 to May 2011, 6 patients were enrolled to this trial from New York University Medical Center and its affiliated hospitals.|
743097|NCT01003899||
743098|NCT01003886||
743099|NCT01003769||
743100|NCT01003639|Participants were enrolled at 38 academic and private practice sites in North America from March 2010 to November 2012,with follow-up ending in June 2013.|Randomization was stratified by site and included blocking to ensure balance among the treatment groups within a site after every 4 participants had been enrolled at that site.
743101|NCT01003418|Only 8 subjects were enrolled in the study as the study was terminated prematurely for logistic reasons, not related to safety or efficacy of the vaccine.|Subjects who were enrolled completed the study but the lack of data due to the small enrollment number prevented any statistical analyses to be performed. No statistical analyses were performed as per planned in the protocol. All study results summarized below are based solely on individual data listings generated.
743102|NCT01003301||
743103|NCT01003288|HCW working at Haukeland University Hospital during the influenza pandemic in 2009|
743104|NCT01003275|Participants were recruited from 2010 through 2011 from Nephrology clinics associated with the University of Washington.|
743105|NCT01003249||
743106|NCT01003210||
743107|NCT01003184||6 patients who were enrolled and randomized, subsequently discontinued the study before receiving study drug. These patients were not included in analysis.
743108|NCT01003106|Eighty-one patients with retinal vein occlusion were enrolled at a single center (The Wilmer Eye Institute, Johns Hopkins Hospital, Baltimore,MD).|
743109|NCT01003080|Patients were recruited from the medical clinics of Weiler and Montefiore hospitals under the Montefiore system in the Bronx, NY. Patients undergoing a total knee arthroplasty (TKA) were recruited over a 10 month period and either received hemostasis with the standard unipolar cauterizing device or the bipolar saline system.|Patients who were on anticoagulation therapy prior to their TKA were excluded from our study as this potentially would increase their amount of post-operative bleeding complicating the results of our study.
743110|NCT01003067||
743111|NCT01002989|Patients with various cardiovascular risk factors attending a hypertension or a diabetes outpatient clinic during the period 10/2009-06/2010 were invited to participate in the study|
743112|NCT01002755||
743113|NCT01002742|Participants were enrolled from February 17, 2010 to November 11, 2011 from 36 different transplant centers.|
743114|NCT01002573||
743115|NCT01002547|Subjects were recruited from the endocrinology and hepatology clinics at two VA Medical Centers (i.e., Audie L. Murphy in San Antonio, TX and Malcom Randall in Gainesville, FL). The study was conducted between June 2010 and September 2016 (recruitment was completed in December 2014).|After initial screening (medical history, physical exam, laboratories, 75-gram oral glucose tolerance test [OGTT]), patients were instructed to keep physical activity and diet constant during the run-in phase (mean duration: 1 month).
743116|NCT01002482|Adult patients who were assumed to require at least 3 days in the ICU were eligible for inclusion. The study, carried out between October 2009 and June 2011, involved 34 ICUs (19 in academic tertiary care hospitals and 15 in community hospitals)|876 participants were eligible but were excluded: 844 Had objection of the treating physician, 32 declined to participate
743117|NCT01002456||
743118|NCT01002339|February 2010|
743119|NCT01002287|"Study Initiation: 31October2009 Study Termination: 24March2010
~Study was conducted in hospitals."|
743120|NCT01002118||
743121|NCT01002105|1/1/2009 - 31 /12/2010, 75 patients recruited from 15 outpatient centers. Of 75, 4 refused and 7 did not meet the inclusion criteria and 64 patients (48 male and 16 female) were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-bli|
743122|NCT01001988|Study participants were enrolled at 3 sites in Thailand and 2 sites in the Philippines.|A total of 596 participants received a single dose of JE-CV in JEC02 and came to Visit 1 (Year 1) in JEC05; 585 participants were included in the Per Protocol Analysis set.
743123|NCT01001975||
743124|NCT01001832|Study started 8 December 2009; short-term period ended 25 February 2011; long-term period ended 26 October 2012.|171 participants were enrolled, 118 participants were randomized and treated in the short-term period.
743125|NCT01001806||
745430|NCT00880997|Thirty-five subjects were randomized into the study, with 30 subjects returning and receiving at least one dose of medication.|
743126|NCT01001767|From April 22, 2009 to September 1, 2009 35 individuals were enrolled and randomized. Participants were recruited from the Special Immunology Unit at University Hospitals Case Medical Center and from other HIV clinics in Cleveland, Ohio.|No wash out, run-in or transition period required for this study.
743127|NCT01001702||An open-label rollover study for participants who completed study 31-03-241 (NCT00102518). The withdrawal criteria for this open label rollover study was completion by 31 December 2012 (or if Month 72 occurred within 6 months of this date) or if there was commercial availability.
743128|NCT01001598|Patients recruited from clinic and by letter to Pediatric Hematologists in USA|"Patients with documented Fanconi anemia (FA) or dyskeratosis congenita (DC)
~Peripheral blood cytopenias (without transfusion, and at least one result obtained in the past two months that meet criteria): ANC < 500/uL or platelets < 30,000/uL or Hb < 8.0 gm/dl
~. Not pregnant
~Not on birth control
~Consent
~3 yrs/ > 14 kg."
743129|NCT01001572|932 participants were entered into the single-blind valsartan 160 mg arm. 278 participants were discontinued from the single-blind arm. 654 participants were randomized into the double-blind treatment phase; 329 to the Valsartan/amlodipine arm and 325 to the valsartan alone arm.|
743130|NCT01001559|Single site, retrospective chart review of subjects administered a combination of Deplin and an SSRI or SNRI. The 242 subjects were 18-70 years of age (inclusive) and received their respective therapies between January 2007 and September 2009.|Criteria that excluded patients were folic acid supplementation >400mcg, current or a history of psychotic features, bipolar disorder, a history of vagus nerve stimulation, electroconvulsive, or transcranial magnetic stimulation therapy. Any concomitant antipsychotic therapy in the most recent 4 weeks.
743131|NCT01001546||
743132|NCT01001520|Recruitment began in March 2010. Former study subjects with a known catechol-O-methyltransferase (COMT) genotype and who asked to be contacted for future studies were invited to participate, as well as potential subjects who called our center in response to advertising. All sessions were completed in our clinic at the University of Pennsylvania.|2670 subjects completed initial screening over the phone; 669 (25%) were eligible. Of these, 418 (62%) scheduled an in-person screening visit; 218 (50%) attended this visit. 73 (17%) provided blood samples to determine final eligibility, based on genetic & liver function tests. 54 (74%) reached final eligibility; 46 (85%) started study medication.
743133|NCT01001494|This study was conducted at 103 sites (100/103 randomised patients), 10 sites in the Czech Republic, 5 in France, 17 in Germany, 13 in Hungary, 3 in Italy, 1 in Peru, 21 in Poland, 10 in the Russian Federation, 5 in Spain, 13 in South Africa and 5 in the Ukraine. The first patient was screened in Oct 2009 and the last patient visit was in Nov 2010.|Patients fulfilling inclusion/exclusion criteria at the time of the Screening Visit were entered into a run-in period of 14±3 days to assess patient's disease stability.
743134|NCT01001442||The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).
743135|NCT01001429|Subjects were recruited the morning of surgery in the Same Day Surgery Suite|One subject withdrew consent prior to group assignment. One subject surgery was cancelled
743136|NCT01001403||
743137|NCT01001390|Two participants were enrolled at St. Jude Children's Research Hospital (SJCRH) between February 2010 and January 2011. The study was terminated due to poor accrual and poor participant compliance.|Participants had a diagnosis of acute lymphoblastic leukemia and had developed foot drop during treatment for their leukemia. Randomization was to one of two reporting groups: (1) With then without AFO, and (2) Without then with AFO.
743138|NCT01001377|"First patient enrolled on 2nd February 2010 and last patient enrolled 19 July 2012.
~Results are reported as of the data cut-off date of 5 February 2013."|
743139|NCT01001325|"Enrolment start: October 5, 2009 Enrolment complete: February 3, 2010
~Enrolment was conducted from a variety of work places and university settings."|
743140|NCT01001299||The five probe parent drugs used in the study were caffeine (metabolite: paraxanthine), S-warfarin (no metabolite), omeprazole (metabolite: hydroxy [OH]-omeprazole), dextromethorphan (metabolite: dextrorphan), and midazolam (metabolite: OH-midazolam).
743141|NCT01001234||Participants randomized to double-blind study medication (Stage 1 - placebo or rizatriptan in a 20:1 ratio) at the Screening visit were given study drug and administration instructions. If a participant had not treated a qualifying migraine attack within up to 2-4 months, he/she may have been discontinued from the study
743142|NCT01001221|Participants were enrolled in 4 sites in the United States. Since it was not possible to determine the maximum Tolerated Dose (MTD) in study part 1, no participant was enrolled in study part 2 and the study was stopped.|"At each dose level, there was a 1-week gap between the treatment of the first participant and the next 2 participants to evaluate toxicity.
~Before escalating to the next dose level, at least 3 participants were to be evaluable for the criteria defining dose limiting toxicity (DLT)."
743143|NCT01001208|Participants were enrolled from 09 November 2009 through 25 June 2010|
743144|NCT01001195||
743145|NCT01001169||
743146|NCT01001104||
743147|NCT01001078|Recruitment was done at a university hospital mainly in the ambulatory surgery unit from september 2009 to april 2011. 50 patients were recruited in 2009, one fourth in 2010 and the last fourth in 2011. 311 patients were assessed for eligibility, 211 were excluded. 178 did not meet inclusion criteria and 33 declined to participate.|
743148|NCT01001052||
743149|NCT01000987|Of the n=60 subjects who completed the parent study (NCT00580645), n=44 elected to also complete the current protocol.|
743150|NCT01000974||
743151|NCT01000961||Participants randomized to each per sequence Arm are expected to remain in the same Arm throughout all intervention periods.
743152|NCT01000818|Participants were recruited through Abbott Northwestern Hospital Infectious Diseases Clinic, Minneapolis, MN and Prism Research, St. Paul, MN, between June 2008 and March 2009.|A total of 18 participants were enrolled in the study.
743153|NCT01000805||
743226|NCT00996944|This study was prematurely terminated after 5 months had passed since its initiation, because GlaxoSmithKline (GSK) concluded that it was impossible to recruit sufficient participants within a reasonable timeframe. In this study, no participants had completed. The maximum duration was 24 weeks plus follow-up (up to Week 64).|
743227|NCT00996931||
743154|NCT01000727|The study was conducted at 868 centers in 36 countries: North America (282), Western Europe (210), Eastern Europe (166), Asia/Pacific (127), South America (83) during 07 December 2009 to 24 April 2014. A total of 13026 participants were randomized to the study.|During the screening phase of the study, participants presenting with acute coronary syndrome (ACS) were randomized within 30 days. Approximately 77% of participants underwent percutaneous coronary intervention (PCI) for the qualifying event.
743155|NCT01000662||
743156|NCT01000649|Total 55 patients were screened and 53 were randomized. One patient randomized to placebo died before dosing, and one patient randomized to 2.5 ng/kg/min was erroneously dosed with placebo.|
743157|NCT01000610||
743158|NCT01000506|Participants (par.) who met the eligibility criteria at screening, entered the two week Run-in phase and par. who met the randomization eligibility criteria at the end of the Run-in phase entered into the 52-week Double-blind treatment period followed by a 4-week Follow-up phase. The total duration of participation in the study was 58 Weeks.|A total of 888 par. were enrolled, of these, 168 were screen failures and 720 entered the run-in phase. 99 participants were run-in failures and 621 completed the run-in phase and were randomized. Of these, 616 participants were randomized and received treatment and were included within the Intent-to-Treat (ITT) Population.
743159|NCT01000493|A total of 129 participants with posttraumatic stress disorder were randomized to either orvepitant (GW823296) 60 milligrams (mg) or placebo at 26 centres in the United States. Intention to treat (ITT) population included total of 120 participants.|The study was prematurely terminated on 11 May 2010 upon the recommendation of the Data Safety Monitoring Board.
743160|NCT01000480||Study treatment had 2 phases and follow-up. Induction phase: 2 cycles of pemetrexed-cisplatin. Then, if eligible, the concurrent phase: 2 more cycles of pemetrexed-cisplatin and thoracic radiotherapy. Follow-up period: Started when treatment discontinued or completed, and lasted up to 2 years after first dose of pemetrexed.
743161|NCT01000376|This study was conducted at 1 center in The Netherlands during the period of Feb 2009 to Jul 2009.|
743162|NCT01000337|The study was conducted between October 2009 and July 2011 in Aretaieo University Hospital, Athens, Greece|Potential participants prior to group assignment were enrolled but excluded from the trial due to exclusion criteria as defined by the study protocol
743163|NCT01000324|Subjects who entered the study at Years 16, 17, 18, 19 and 20 time points were subjects who completed the primary study and who returned for blood sampling at the considered time point. At Year 19 time point, one subject was given a challenge dose of Engerix.|
743164|NCT01000311|Subjects were enrolled at 42 study sites in the United States, 3 sites in Australia and 1 site in Canada.|All enrolled subjects were included in the study.
743165|NCT01000285|The study opened to participant enrollment on 12/22/2010 and closed to participant enrollment on 05/29/2014.|
743166|NCT01000155||
743167|NCT01000064||Of the 22 cases enrolled, five were lost prior to the baseline assessment (moved, unable to contact, no-showed). Two cases were left on hold. Two cases met safety end-point criteria before group assignment. This left 13 individuals who were assigned to groups.
743168|NCT01000051||Four participants that was enrolled was taken off the study before the randomization process, therefore not included in the participants that started.
743169|NCT01000025||
743170|NCT00999921|Premenopausal women with Benign Breast Disease and who belong to non-high risk group for breast cancer were included in the study|Postmenopausal women, premenopausal women with pregnancy or other contraindications to tamoxifen, girls less than 15 years, very large lesions, high risk patients with epitheliosis, atypia or atypical hyperplasia or prone to develop malignancy and patients unwilling to undergo treatment were excluded from the study
743171|NCT00999908||
743172|NCT00999830|Patients were recruited in France at the public hospital (10 actives center), from mid of November 2009 to end of October 2011.|All patients enrolled in the study were analyzed. There was no screen failure during the trial conduct.
743173|NCT00999804|Participants were recruited between October 2011 and July 2014 at 10 study sites: Baylor College of Medicine, UAB, University of Chicago, Johns Hopkins, Duke, Indiana University, Vanderbilt, MDACC, DFCI, and Mayo Clinic.|Participants screened up to 28-day period.
743174|NCT00999713||
743175|NCT00999687|Participants recruited from ambulatory department of Chang Gung Memorial Hospital, in northern Taiwan between November 2009 and May 2011.|35 participants recruited and screened, 4 excluded (3 did not meet the eligibility criteria and 1 refused participation).
743176|NCT00999661|Subject recruitment began in November, 2009 at 7 surgical centers in the United States.|This was a longitudinal, single arm, observational, non-comparative study of clinical outcomes. Subjects were asked to consent to data collection to the study parameters from their study records.
743177|NCT00999609||
743178|NCT00999596|Recruitment was initiated at out primary Diagnostic site in April 2010 and concluded in February 2011. A total of 35 diagnostic cases were obtained. Recruitment was initiated at out primary Screening site in May 2010 and concluded in November 2011. A total of 67 screening cases were obtained.|The trial was to evaluate performance of a FFDM system. During image acquisition FDA modified the trial criteria from an efficacy trial to a SE trial. Images from our diag site prior to Nov could not be used in this study as mag views were now required. Mag views were acquired in Jan-Feb 2011. Selected images were used from our screen site.
743179|NCT00999544|All recruitment was conducted through a research clinic at a public university.|Subjects were initially screened for inclusion/exclusion criteria. Fifteen subjects signed the screening consent but only nine were qualified to participate and signed the study consent. One subject left the study before receiving any interventions.
743180|NCT00999466||
743181|NCT00999167|Part A enrollment: 01 December 2009 to 24 February 2010 Part B enrollment: 01 June 2010 to 31 October 2011|The study consisted of Part A, an open-label, dose-escalation lead-in to assess HPN-100 safety and PK, followed by Part B, a randomized, placebo controlled study to assess safety and efficacy of HPN-100.
743182|NCT00999141|Patients were enrolled at 7 clinical sites in the United States, beginning September 2009 and completing in December 2009|79 participants were enrolled and screened. 2 were screen failures and 2 requested withdrawal. Therefore, 75 of the 79 enrolled were randomized.
743306|NCT00993200|Twenty six subjects were enrolled and randomized|Naive to warfarin were randomized to groups
743307|NCT00993187||
743308|NCT00993148||
743183|NCT00999102|Subjects were recruited from the patient population of the Hypertension Center, and from an announcement at the medical center. Subjects were entered from 10/09 to 9/10, and the final subject completed the protocol in 1/11.|Subjects who were on anti-hypertensives were instructed to continue their medications. Subjects taking a beta-blocker were instructed to stop them. There was no washout period. Individuals with a contraindication to beta-blockers were excluded. 4 subjects dropped out before starting medication for reasons unrelated to the study.
743184|NCT00999037||
743185|NCT00998985|One of the originally planned treatment groups (50 mg Grazoprevir - GT3) was not conducted because other results indicated that further evaluation of 50 mg Grazoprevir in GT3 participants was not necessary. It is therefore not included in the Participant Flow.|
743186|NCT00998881||
743187|NCT00998868|Recruitment period: Jan, 2008 - Dec, 2009 Recruitment site: Seoul National University Eligible canditates from: inpatients in the department of rehabilitation medicine of the hospital Methods of recruitment: research physicians informed about the study to all eligible candidates and asked if they agreed to participate.|The study was designed to recruit hemiplegic patients of diverse degree of paresis with the same size. Because the crude distribution of the motor weakness was not even, the recruitment process adjusted the distribution of the severity of paresis, by recruiting patients of different motor strength in a consecutive way.
743188|NCT00998790|114 subjects were enrolled for this study and 113 treated across 7 sites in Europe.|
743189|NCT00998764|This study was conducted at 147 centers in 19 countries. The study was terminated early by the sponsor on 06 August 2012. Subjects who had not completed the final follow-up visit prior to 06 August 2012 were asked to complete an early termination visit.|
743190|NCT00998738|One participant was recruited between November 2009 and July 2010 at Mayo Clinic. This trial was terminated in July 2010 due to lack of accrual. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|
743191|NCT00998660||
743192|NCT00998582||
743193|NCT00998517||
743194|NCT00998426|Adult OLT recipients receiving maintenance HBIG therapy were recruited from the inpatient liver transplant service.|
743195|NCT00998400||
743196|NCT00998374||
743197|NCT00998335|Clinical Research Unit|"All participants started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio to either Insulin detemir only arm or to Insulin detemir plus aspart."
743198|NCT00998309|This was a phase 4, observational, open-label study conducted in participants who were prescribed azithromycin by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.|
743199|NCT00998296|Trial consisted of a dose-escalation phase (to determine the maximum tolerated dose (MTD) of treatments administered concomitantly) and an expansion phase(to assess the safety and the preliminary anti-tumour activity of the combination therapy at the previously determined MTD in patients with non-small cell lung cancer or pancreatic adenocarcinoma)|
743200|NCT00998205||
743201|NCT00998049|Forty (40) participants were recruited at Mayo Clinic (Rochester, Florida and Arizona) between December 2009 and October 2011.|One participant was deemed ineligible and is excluded from all analyses per study design.
743202|NCT00998023|Participants were recruited from the clinical practice of the investigator between November 2009 and July 2010.|Participants who had any groin pain before placement of the closure device were excluded.
743203|NCT00998010|Recruitment period: 10/03/2011 - 4/17/2015 Location: University of California at Los Angeles, Columbia University, New York.|There are no pre-assignment details to describe.
743204|NCT00997984||
743205|NCT00997932||All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
743206|NCT00997893||A total of 63 of the 96 enrolled subjects met the post-enrollment eligibility criteria. Twenty-three of 63 enrolled subjects withdrew prior to randomization. A total of 40 subjects were randomized.
743207|NCT00997672|Patients were recruited through our outpatient clinic. Recruitment started the 4th June 2010 and the trial was stopped the 22nd of August 2011|Patients were screened prior to randomization, no patients were excluded.
743208|NCT00997620||
743209|NCT00997594||
743210|NCT00997555|From 2009-2012, 33 patients with inhalation injury were admitted to our regional burn center.|Five were never enrolled. Two patient's families refused to consent, and two fell into exclusion criteria number 1. Both died within six hours of admission. The remaining fifth patient self-extubated and thus failed to meet inclusion criteria number 1. This left 28 patients for analysis, all of whom were enrolled and randomized into the study.
743211|NCT00997516|The study population consisted of all patients from May 2010 to November 2012 who presented to the emergency department and were diagnosed with acute appendicitis on the basis of clinical and radiographic evaluation.|88 patients were assessed for eligibility. 5 patients were excluded because the study surgeon was unavailable to perform the procedure. 6 patients declined to participate.
743212|NCT00997503||
743213|NCT00997438|Recruited at PVAMC and OHSU January 2012-December 2013 via fliers, word of mouth and MS clinic screening.|
743214|NCT00997425|"Recruitment of veteran with dementia/caregiver subject dyads included face-to-face recruitment at 2 medical clinics within the same VA hospital and opt out letters mailed to the homes veterans and caregiver participants in a VA-sponsored Alzheimer's Association Safe return program."|
743215|NCT00997386||
743216|NCT00997373|Recruitment by providing gynecologic oncologist beginning 11/2/2009|Non-randomized selection of control subjects
743217|NCT00997334|Study activated December 2009. Patients enrolled from February 2010 - January 2015|
743218|NCT00997321|100 patients recruited in the Emergency Department|97 enrolled subjects underwent procedural sedation
743219|NCT00997243||
743220|NCT00997204||Patients were screened for entry based on their known medical histories (HAE attacks) and previous exposure to a treatment (naïve or not). 151 were enrolled and trained in the self-administration. 47 of these subjects did not have an acute attack of HAE treated with icatibant during this study and were included in the untreated population.
743221|NCT00997139||Only subjects with a positive Baseline culture continued on a treatment arm.
743222|NCT00997126||
743228|NCT00996918|This extension study was conducted at 91 centers in 17 countries. The study was terminated early by the sponsor on 06 August 2012. Participants who had not completed the final follow-up visit prior to 06 August 2012 were asked to complete an early termination visit.|Participants who had completed the base study protocol 3133K1-3000 were allowed to participate in this extension study. Participants who developed vasogenic edema during study 3133K1-3000 were considered for study 3133K1-3002 participation if the abnormality was resolved and the participant met criteria to resume the investigational product.
743229|NCT00996892||Study was terminated before initiation of Stage 2B; hence Stage 2B cohorts were not applicable.
743230|NCT00996840|This study was conducted across 6 centers in the United States, with 5 centers actually enrolling participants. The first participant was enrolled on 16-October-2009 and the last participant completed the study on 09-February-2013.|Seventy seven participants were randomized in the study and were included in All subject population.
743231|NCT00996801||
743232|NCT00996775||
743233|NCT00996736|Between April 3, 2010, and December 31, 2011, patients were recruited from the Cornea Clinics at the Aravind Eye Care Hospitals in Madurai, Pondicherry, and Coimbatore in Tamil Nadu, India.|
743234|NCT00996658||
743235|NCT00996632|Patients affected by Breast Cancer|
743236|NCT00996606||
743237|NCT00996593||Participants received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases: Phase 1, dosimetric dose; Phase 2, therapeutic dose. After radioimmunotherapy, participants could have entered a 10-year Long-Term Follow-Up study (Study BEX104526; NCT00240591) for continued evaluation.
743238|NCT00996580||A total of 4,962 subjects were screened for participation in this study, and 3,597 took at least one dose of investigational product (Safety population).
743239|NCT00996502|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to the IRB in March 2010.|
743240|NCT00996489|The study was conducted at 20 sites in the United States.|A total of 459 participants were screened, enrolled and treated in the study. Of these, 298 participants completed the 36-month study.
743241|NCT00996476|The study was conducted between 6 July 2009 and 1 April 2011 and recruited participants with chronic Hepatitis C Virus (HCV) infection from 25 study centers in Japan. A total of 93 participants were randomized, 92 treated, and 85 completed the study (1 participant in the TMC12/PR24 100 mg arm withdrew consent and did not receive study treatment).|Treatment-naïve HCV-infected participants were randomized to 1 of 5 treatment arms and received 12 weeks of TMC435 50 or 100 mg once daily with PegIFNα-2a and ribavirin (PR) followed by 12 weeks of PR (Arm 1 and 2); 24 weeks of TMC435 50 or 100 mg once daily with PR (Arms 3 and 4); and, PR for 48 weeks (Arm 5).
743242|NCT00996437||
743243|NCT00996372||
743244|NCT00996346|Subjects were recruited between October, 2009, and May, 2011|
743245|NCT00996333||
743246|NCT00996307|Participants were enrolled at 29 sites in USA and Mexico. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.|All subjects enrolled were included in the trial. The data entered is for the overall study.
743247|NCT00996281|Participants took part in the study at 79 investigative sites in the United States, Netherlands, Poland, the United Kingdom and Germany from 27 October 2009 to 17 November 2011.|Participants with a diagnosis of essential hypertension were randomized to receive open-label treatment with either Azilsartan Medoxomil and Chlorthalidone or Olmesartan Medoxomil and Hydrochlorothiazide for up to 52 weeks.
743248|NCT00996216|10^9 cells (Giga) per liter=Gi/L; participants=par.; polyethylene glycol=Peg; interferon=INF.|In Part (P) 1, the treatment goal was to increase the platelet count to >=90 Gi/L. In P 2, par. continued on the selected P 1 dose of eltrombopag (dose effectively raising platelets to >=90 or >=100 Gi/L). Eltrombopag was given in combination with antiviral therapy (Peg INF alfa-2a or Peg INF alfa-2b and ribavirin) for the duration of treatment.
743249|NCT00996203||
743250|NCT00996164||
743251|NCT00996125||
743252|NCT00996034|Enrollment in to the study ended in Feb. 2011. Subjects were screened and recruited from the VA West Haven, CT.|Several possible subject were not enrolled in to the study because of the exclusion/inclusion criteria, such as allergies to medications, high blood pressure, or SCID II diagnosis
743253|NCT00995930||Participants were randomized in a 1:1 ratio to each treatment arm.
743254|NCT00995904||This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.
743255|NCT00995865|"2 of the Subjects in the High-Dose made it thru the study, however, it was later found that those 2 subjects vaccinated prior to joining this study. One (1) subject in the Placebo went thru the the study, but was later lost to follow-up."|60 Subjects enrolled in this study. 3 Subjects discontinued in this study.
743256|NCT00995774|"Recruitment was through word of mouth with therapists at the outpatient clinics of the DC Veterans Affair Medical Center and the MedStar National Rehabilitation Hospital. Recruitment took place approximately between 9/2010 and 3/2012."|Fourteen individuals were recruited. One subject was excluded due to a prior orthopedic injury and another subject did not meet the Folstein Mini-Mental State Examination criterion. Two subjects completed the protocol up through the initial training period and the washout period, but did not return for the second therapy block.
743257|NCT00995761|anticipated dates of final recruitment: September 2011 Type of location: University Hospital Clinic|not specific problems
743258|NCT00995722||
743259|NCT00995709||
743260|NCT00995670|Volunteers were sought from our research subject database.|None. This was not a clinical intervention study but basic science research in young healthy humans. Primary exclusion criteria included anyone on beta-blockers or other med that would affect vascular responses; pregnant or lactating women; substance abusers; smokers; and cardiovascular, renal or systemic disease including hypertension & diabetes.
743261|NCT00995566|The Sitaxentan Sodium program was discontinued December 10, 2010.|
743309|NCT00993044||
743310|NCT00993031||
743311|NCT00992992||
743262|NCT00995553|86 individuals were enrolled in the study. However, prior to condition assignment, 3 participants indicated that they needed to withdraw due to transportation problems, 1 participant withdrew due to a medical condition, and 1 participant lost interest in the study. Therefore, 81 participants were randomized to a study condition.|
743263|NCT00995501||
743264|NCT00995488||
743265|NCT00995475||This is a randomised, double blind placebo controlled cross over trial design will be used. Following a two-week steroid tapering process and a two-week run in period, two randomised treatment periods will follow. Each will be one month in duration and will be separated by a two-week wash-out period.
743266|NCT00995449|This was a two-part study with a safety run-in. The primary objective of the main portion of the study was to evaluate the safety, PK, and efficacy of selected repeat-dose regimens of KB003 in subjects with active moderate to severe rheumatoid arthritis who had an inadequate treatment outcome from prior biologic therapy.|The safety run-in portion was conducted in a small cohort of 7 active and 2 placebo subjects to evaluate the acceptability of repeat-dose safety. KB003 was administered by intravenous (IV) infusion as a 600 mg dose at wks 0, 2, 4, 8, and 12, with primary safety being evaluated at wk 14 and a follow-up (end of study) safety assessment at wk 30.
743267|NCT00995436|This trial was conducted between August 2008 and February 2013 in two orthodontic departments in the United Kingdom.|90 patients assesses as eligible. 12 chose not to take part
743268|NCT00995410|A multi-center US study in which 44 sites recruited subjects between November 2009 and May 2010|Screening for eligibility and wash-out of restricted medications
743269|NCT00995371|Patients were enrolled through one site (Coastal Orthopedics) between September 2009 and January 2011.|Randomization occurred in blocks of four. After Week 6 post-treatment and prior to 4 months, ESI arm participants were allowed to cross over to mild if they chose to have it.
743270|NCT00995345|Conducted in 55 medical clinics in 6 countries: US, Guatemala, South Africa, Russia, Czech Republic, Poland. First site opened 19 October 2009.|Variable screening duration to allow for wash-out of one oral therapy, optimization and stabilization of dose on metformin monotherapy (>= 10 weeks);followed by 2 week placebo run-in. Fasting CBG <240 mg/dL at start of run in and prior to randomization required.
743271|NCT00995215||
743272|NCT00995085||
743273|NCT00995072||4 subjects were randomized and dropped from the study prior to taking the study medication
743274|NCT00995020|Between November 1999 and December 2004, patients were assessed for eligibility, the great majority in Rio de Janeiro.|127 women were eligible for both arms: 5 refused to participate, 19 did not meet inclusion criteria.
743275|NCT00995007||
743276|NCT00994929|Nine (9) subjects 18 years or older, including five with mild or moderate hemophilia A (HA) and four with mild or moderate von Willebrand disease (VWD) unresponsive or allergic to DDAVP were enrolled in and completed the study between January 2010 and February 2012.|Following enrollment, subjects initiated study drug.
743277|NCT00994760||
743278|NCT00994682|Participants were recruited from the general population of San Antonio, Texas, via newspaper advertisements and from the endocrinology and hepatology clinics at UTHSCSA and the Veterans Affairs Medical Center.|Once eligibility was met by histologically confirmed NASH, patients were randomized. The number of patients consented was 176, screen failed was 38, did not complete run-in phase was 37 (12 consent withdrawn, 9 lost to follow-up, 4 discontinued by PI decision, and 12 for other reasons). The remaining 101 patients were randomized.
743279|NCT00994643||
743280|NCT00994604||
743281|NCT00994461|Subjects were screened at 3 centers in Japan.|
743282|NCT00994448|substance abuse clinic, community outreach|Reasons for not being randomized were: withdrew voluntarily (4), failed to complete assessments (2), psychiatric disorder (2), weight < 50 kg (2), alcohol dependent (1), and incarcerated (1).
743283|NCT00994422|Participants were enrolled and treated from 13 October 2009 to 02 December 2009 in 12 US clinical centers.|A total of 247 of the 264 randomized participants who met the inclusion and exclusion criteria received treatment in the study.
743284|NCT00994318||
743285|NCT00994279|Participants were recruited from three NCI CCOP sites between 1/2010 and 8/2011|
743286|NCT00994240||
743287|NCT00994214|This was a multicentre study conducted at 36 investigational sites in 16 countries: Czech Republic, Lithuania, Poland, Romania, Ukraine, Latvia, USA, United Kingdom (UK), Italy, Mexico, Brazil, France, Belgium, Netherlands, Germany and Sweden.|Screened subjects were 109 and screen failures were 33. Subjects randomised and treated in part A were 76. Subjects completed part A were 21 and subjects entered Part B were 12, excluding 9 subjects, who chose not to continue in part B. No subjects completed the study.
743288|NCT00994175||
743289|NCT00994123||
743290|NCT00994110||
743291|NCT00993967||
743292|NCT00993954||2 Patients in the physician group were incorrectly reduced by the triage nurse 21 patients in the nurse group either had no study form or the nurse did not attempt reduction
743293|NCT00993928||
743294|NCT00993915||
743295|NCT00993824|Recruitment Jan 2010 to Mar 2011. Medical Clinic Setting.|
743296|NCT00993668|This study started in September of 2009 with recruitment occurring in the United States. The primary outcome completed in June 2010 and the open-label extension completed in February 2011.|Treatment column headings reflect the treatment received in the Single-Blind (SB) period.
743297|NCT00993655||
743298|NCT00993616||
743299|NCT00993499||
743300|NCT00993473|The study was conducted in 61 centers (72 were initiated) in 16 countries between October 15, 2009 and March 30, 2011.|A total of 165 patients were screened and 125 were randomized. Forty patients (24.2%) failed the screening selection process, mainly due to noncompliance with the study required Continuous Glucose Monitoring (CGM) performance and other procedures.
743301|NCT00993447|Study participants were enrolled from 09 October 2009 to 25 February 2010 in 3 clinic centers in Colombia, 1 in Honduras, 3 in Mexico, and 1 in Puerto Rico.|A total of 600 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
743302|NCT00993421||
743303|NCT00993317|Dates of the recruitment period : from 03 Nov 2009 to 16 Dec 2010 Types of location : clinic of rheumatology|
743304|NCT00993291||
743305|NCT00993265||
743312|NCT00992927|Recruitment Dates: from Mar 2008 until Oct 2009 Type of Location: outpatient clinic at a university hospital Method of Recruitment: informed consent from eligible patients|Participants with other diagnoses than the painful stiff shoulder, such as full-thickness rotator cuff tear, osteoarthritis and others, were excluded from the trial when the final diagnosis was determined.
743313|NCT00992836|Participants were enrolled from 37 sites between October 14, 2009 and November 12, 2009. Participants were stratified by age in three groups: >=4 to < 9 years old, >=9 to < 18 years old and >=18 to <25 years old.|One study participant was inadvertently enrolled with acute illness, was not given any vaccination and was immediately taken off study. A second study participant received the first vaccination but it was discovered that he/she was not compliant with the ARV regimen and was taken off study before receiving the second dose of vaccine.
743314|NCT00992784||
743315|NCT00992719|Participants were healthy pregnant and non-pregnant women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09Nov2009 and 04May2010.|
743316|NCT00992602||
743317|NCT00992589||
743318|NCT00992511||
743319|NCT00992459|Forty six subjects were screened and randomized at the participating sites between October 2009 to August 2010.|There were no screen failures.
743320|NCT00992446||
743321|NCT00992433|Participants were HIV-positive adult males and females recruited from existing patient populations and from the communities at large around the clinical sites. Participants were enrolled between 19Nov2009 and 23Apr2010.|
743322|NCT00992407||
743323|NCT00992394|This multicenter open label, randomized study screened 209 participants in 44 sites.|Psoriasis participants who had responded to initial treatment with ETN were enrolled in this study. Participants were randomized to 2 groups: Stop arm, stopped etanercept (ETN) treatment on study entry and could be retreated with ETN 50 mg once weekly. Maintenance arm, continued ETN treatment at 25 mg once weekly, but could increase dose to 50 mg.
743324|NCT00992264|Participants were recruited from Group Health, a large, non-profit health plan in the US Pacific Northwest. Data were collected between May 2010 and November 2012. All intervention and data collection occurred online.|
743325|NCT00992225||
743326|NCT00992186||16 out of 62 participants, who signed informed consent, were deemed ineligible for the study during screening because of screening failure, serious adverse events, unavailability of carlumab at the site and withdrawal of consent.
743327|NCT00992108||
743328|NCT00992056||
743329|NCT00992017|Pregnant women were enrolled from 31 sites between October 8, 2009 and November 13, 2009.|Two study participants were enrolled but left the clinic before receiving any vaccination and they were taken off study.
743330|NCT00991952|Protocol Open to Accrual 09/09/2009 Protocol Closed to Accrual 02/28/2012 Recruitment Location is the medical clinic|
743331|NCT00991939||
743332|NCT00991887||
743333|NCT00991809|Study enrollment began in February 2009 after Institutional Review Board (IRB) approval. Screening started on 2/9/09. The last person was screened on 3/12/2010 and finished the study in April 2010. A total of 42 screenings occurred and 12 persons completed the study. Recruitment was conducted at the Behavioral Pharmacology Research Unit (BPRU).|Since study initiation in February 2009, there were 42 persons consented. There were 13 screen failures [4 had urines positive for illicit substances, 4 had BMI>30, 5 had active medical problems]. Seven met study criteria but decided not to start as they could not commit to study schedule (N=6) or did not like blood draws (N=1)
743334|NCT00991510||A total of 100 subjects were planned. A total of 47 subjects were screened in the study. Four subjects were not randomised, i.e., two subjects withdrew consent, one subject had a protocol violation, and one subject was a screening failure (did not meet eligibility criteria).
743335|NCT00991458||
743336|NCT00991406||Computational optimization was via tracking joint angles & ground reaction forces from an able walking subject.We optimized the hemiparetic (HP) subject's model to able data & their walking data producing optimization solutions for muscle activations in each case.The able subject was not considered enrolled,only 9 HPsubjects were actually enrolled.
743337|NCT00991341|RECESS recruitment took place at 33 US hospitals, beginning in January 2010 and ending in January 2014.|Randomization was stratified by age (≥18 yrs or <18 yrs) and by whether or not the subject was in the ICU prior to surgery. A subject could not be randomized unless prior to surgery but no earlier than one calendar day prior to surgery, the transfusion service had enough suitable units of both storage durations to satisfy the cross-match request.
743338|NCT00991302||
743339|NCT00991289|Men and women at least 18 years of age with genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection and naive to previous HCV treatment were recruited for participation in this study.|
743340|NCT00991276||
743341|NCT00991185||
743342|NCT00991081|Phase I and Phase II participants were recruited from members of Group Health Cooperative in Seattle, WA. Of the 36 Phase II participants enrolled, 32 had been previously genotyped for an earlier study and 4 were genotyped for this study.|
743343|NCT00991029||
743344|NCT00990964||
743345|NCT00990938||
743346|NCT00990821|One Investigator in the United States. Primary therapy period: 31-Jan-2005 to 01-Dec-2005.|
743347|NCT00990782||
743348|NCT00990769|Parents or guardians of children undergoing ophthalmologic surgery were approached, when possible, at their pre-anesthesia evaluation visit. All eligible patients were notified about the study through fliers at their pre-operative visit, and eligible patients who were missed pre-operatively were approached for consent on the day of surgery.|Fifty-seven patients were approached for participation; of these, fourteen declined and three were unable to participate due to surgery cancellation or rescheduling.
743349|NCT00990704||Informed consent was obtained from 92 subjects; 45 of these subjects were not enrolled because they did not meet the eligibility criteria at the time of Screening.
743350|NCT00990665||
743351|NCT00990652|The study opened on May 21, 2009 with an accrual goal of 29 patients; the study was designed to enroll 10 patients initially and do an interim efficacy assessment. Accrual was suspended on February 11, 2011 for this analysis. The interim results did not support further accrual, and so the study was permanently closed to accrual on March 29, 2011.|
743352|NCT00990561|Patients were recruited from our medical clinic as well as through flyers posted at other University of California at San Francisco sites.|Patients were required to have a 2 week washout from topicals, 1 month washout from any systemic agents.
743353|NCT00990509||
743354|NCT00990340|First subject enrolled on 23 September 2009; last subject completed the study on 07 April 2010.|
743355|NCT00990314||A Protocol Amendment was to include an optional arm investigating Beraprost Sodium Modified Release Tablets administered four times daily (QID), however, no participants were enrolled into this arm.
743356|NCT00990288|"Inclusion Criteria:
~1)Diagnosis of knee arthritis in patients medically suitable to undergo unilateral TKA.
~Pre-operative Exclusion Criteria:
~Known allergies to products of bovine origin.
~History of bleeding disorders.
~Pre- or peri-operative complication."|
743357|NCT00990249|Recruitment Period: October 01, 2009 to July 13, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|
743358|NCT00990236||
743359|NCT00990184||
743360|NCT00990106||
743361|NCT00990093||
743362|NCT00989989||
743363|NCT00989963||
743364|NCT00989950||
743365|NCT00989937||The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
743366|NCT00989911||
743367|NCT00989833|On Visit 1, a total of 189 patients, aged 12-67, were enrolled at 10 study sites in 2 countries: Sweden and Norway. Of 189 enrolled patients, 66 patients were randomized and allocated to study treatment on Visit 3 (7 patients in Norway and 59 patients in Sweden).|A standardized exercise test (ECT) with duration of 6 minutes, at approximately 90% of maximal aerobic capacity (as defined on Visit 1) was performed on a treadmill while breathing dry air on Visit 2. Patients with exercised induced bronchoconstriction (defined as fall in FEV1 ≥ 10% ) could be randomized on Visit 3.
743368|NCT00989781|Subjects were recruited from UC San Dego clinics and by advertisement in the community. Recruitment began in the summer of 2011 and was completed in Septemebr 2013. Explanation of the research protocol was done by phone and in person.|41 subjects recruited. 5 dropped out prior to study. Of 36 eligible for adrenal study, 8 dropped out before study,
743369|NCT00989768|A total of 29 subjects was recruited at Brazilian Center For Studies in Dermatology, in Porto Alegre, Brazil. The anticipated drop out rate is 10%. Participants were their own control, because on one side of frontal region they have received 5U of botulinum toxin - Dysport and on other side 4U of botulinum toxin - Botox;|"13 volunteers were excluded; Screen failure: Iodine allergy = 2; Minor´s Test failure = 6 Mild wrinkles = 3 Inclusion criteria failure = 2
~Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands also known as action halos."
743370|NCT00989664||Participants (par.) received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases (Ph.): Ph. 1, dosimetric dose; Ph. 2, therapeutic dose. Par. were evaluated until disease progression, they died, or they were on study for 2 years. Par. completing 2 years of study could enter a long-term follow-up study (BEX104526; NCT00240591).
743371|NCT00989612||
743372|NCT00989586||
743373|NCT00989287||
743374|NCT00989261|A total of 333 participants from 9 countries (United States, Germany, France, Italy, United Kingdom, Spain, Netherlands, Canada, and Poland) who met all inclusion and none of the exclusion criteria were included in the study.|All participants in both cohorts initially received a starting dose of 200 mg/day quizartinib (maximum tolerated dose). To ensure complete inhibition of FLT3, all male subjects in both cohorts later received a starting dose of 135 mg/day quizartinib, and all females received a starting dose of 90 mg/day.
743375|NCT00989235|IM101023 (NCT00122382) was a 2-year study completing on Day 729, in which subjects were randomized to receive abatacept or placebo in combination with methotrexate (MTX) for the 1st year of the study and were then switched to open-label abatacept+MTX in the 2nd year. All subjects had received abatacept for a least 1 year prior start of sub-study.|Of the 433 participants who completed the main study (IM101-023 NCT00122382), 108 enrolled in the sub-study.
743376|NCT00989196|The study was conducted at 6 centers in the USA, 2 centers in Germany and 1 center in Bulgaria. The first patient was included on May 27, 2010 and the last patient finished the study on September 18, 2012|The patients started the study with a PK period. The PK period had a cross-over design (Kogenate vs Human cl rhFVIII) and subjects received either Kogenate first and Human cl rhFVIII second or vice versa. Once the PK measure had been done, the patient started the treatment period with Human cl rhFVIII only.
743377|NCT00989157||
743378|NCT00989092|First Patient Randomized: 24-Jun-2002 Last Patient Randomized: 08-Aug-2003|
743379|NCT00989014||
743380|NCT00988884||
743381|NCT00988858||Participants that had progressive disease were completers.
743382|NCT00988832|No subjects were recruited for this retrospective study; participating investigators reviewed medical records of qualifying subjects and provided data to the sponsor.|
743383|NCT00988637|Dates of recruitment period: First subject was enrolled on October 26, 2009 and the last subject was enrolled on January 28, 2010.|Wash-out period up to baseline is 30 days for any steroid containing medication, dovonex, anthralin, tar and/or ultraviolet B (UVB) treatment; 12 weeks for corticosteroids, biologics and/or psoralen + ultraviolet A (PUVA) treatment.
743384|NCT00988598||Eligible participants enrolled in this study were already on prior stable donepezil therapy.
743385|NCT00988559||"132 subjects signed consents to be screened for eligibility
~93 subjects signed consents, but did not meet the eligibility criteria to start the study (screen failures)
~39 subjects were assigned to a treatment group in the study"
743386|NCT00988533|Participants were enrolled and treated from 22 September 2009 to 18 November 2009 at 3 US clinical centers.|A total of 30 participants who met the inclusion and exclusion criteria were enrolled and treated.
743387|NCT00988442|Recruitment occurred between April 21, 2011 (first participant enrolled) and October 18, 2012 (last participant enrolled).|59 participants were randomized 1:1 to standard care and enhanced nursing telephone support with standard care arms.
743419|NCT00986921|Patients were recruited from the abortion clinic, after they had already consented to the abortion procedure, October 2009 to March 2011.|All women enrolled were assigned to groups. Group assignment was done very shortly after enrollment.
743420|NCT00986856||
743421|NCT00986830||
743388|NCT00988429|"A total of 173 investigational sites in 19 countries (North America, 89 sites; Rest-of-World [ROW], 84 sites) screened and enrolled subjects. Of these, 160 sites randomized subjects into the study.
~Studied period (years):
~First subject first visit: 02 December 2008
~Last subject last visit: 12 January 2012 (Part I)"|The first period was an 8-week observation baseline period (Week -8 to Week -1) during which subjects were instructed on how to complete the seizure diary. At the end of the 8 week observational baseline period, eligible subjects were randomized in a 1:1:1 allocation ratio to 1 of 3 treatment groups (with a blinded treatment assignment)
743389|NCT00988351||
743390|NCT00988325|The study was conducted across 11 centers in Spain, Italy, France, Germany, Belgium, and Poland from 10 January 2011 to 04 April 2012. A total of 65 participants were screened.|
743391|NCT00988247|A total of 857 patients were screened and 775 patients were enrolled in the study and participated in the Run-in Period. Of the 775 enrolled patients, 529 were randomized to study treatment.|During the 7 to 21 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their daily seasonal rhinitis symptoms to determine eligibility for randomization.
743392|NCT00988221||In Part I, patients received either tocilizumab 8 or 10 mg/kg. In Part II, eligible patients were randomized to receive placebo or the same dose of tocilizumab as in Part I of the study. In Part III, patients received the same dose of tocilizumab as in Part I of the study, with adjustments based on weight and change in weight from Baseline.
743393|NCT00988208|Following a safety and efficacy data review by the Data Monitoring Committee( DMC), the trial was stopped for futility. At that time, 1059 participants had been randomized and 1046 treated with either lenalidomide plus docetaxel and prednisone or placebo plus docetaxel and prednisone. A data cutoff date of 13 January 2012 was established.|Participants who had started a treatment cycle at the time of termination request were allowed to complete the cycle and have their discontinuation visit at the next cycle (21 days later). The safety follow-up of 28 days was also added to ensure all adverse events were followed.
743394|NCT00988169||
743395|NCT00988156|73 clinical centres in 20 countries Date first patient enrolled: 07 Dec 2007. Date last patient completed the double-blind treatment period (Part I): 20 Aug 2012.|
743396|NCT00988143|The study participants were enrolled from 01 October through 05 November 2009 in 4 clinical centers in the US.|A total of 600 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
743397|NCT00988117|Patients were recruited from UCSF movement disorders neurologists, regional Parkinson's Disease (PD) support group meetings and advertisements in PD newsletters between 4/2010 and 1/2011.|
743398|NCT00988091|A total of 1007 subjects were screened for the double-blind period of the study, and 596 subjects were randomized and treated (safety population).|
743399|NCT00988065||A total of 480 participants received a single-blind placebo dose 7 days prior to randomization. Of these 480 participants, 448 were randomized to double-blind treatment.
743400|NCT00988052|In the preceding double-blind, placebo-controlled ALLEGRO study (study MS-LAQ-301), 1106 subjects with RRMS were randomized to treatment, and 864 subjects completed the study according to the protocol (ie, by completing the ALLEGRO study termination visit procedures).|In this open-label extension study, 839 subjects with RRMS were enrolled to receive laquinimod 0.6 mg at 135 study sites in 22 countries by 135 investigators.
743401|NCT00988000||Patients' who attending respiratory outpatient clinics
743402|NCT00987948||
743403|NCT00987935|The trial consisted of 2 Phases. Patients were stratified into 1 of 2 groups according to their aspartate aminotransferase (AST)/alanine aminotransferase (ALT) and Child-Pugh score at baseline.|"Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
~Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN"
743404|NCT00987831|The final recruitment tally is as follows: 41 SLE patients entered the prospective serial blood donation study. 62 SLE patients gave one time blood sample and 52 controls gave two blood samples each|All patients in Group A (prospective study) had any immune suppressive (e.g. MMF, MTX, AZA) withdrawn at the time of entry and all received between 1-3 depomedrol shots up to 160 mg each. Those who did not improve were immediately withdrawn from prospective study but the original sample was retained, in all cases, for the cross sectional arm.
743405|NCT00987727||
743406|NCT00987623||Twenty-seven participants were enrolled but not dispensed. These participants were included in the Actual Enrollment calculation, but not in Participant Flow or Baseline Characteristics calculations.
743407|NCT00987558||
743408|NCT00987480||"This is a multicenter site and MSK is the site responsible for data collection and analysis for all sites.
~11 participants were enrolled at Memorial Sloan Kettering Cancer Center. The remaining 34 participants were enrolled at the participating institutions. This makes a total of 45 participants enrolled and treated on this study."
743409|NCT00987467|Patients were recruited from the PI's medical clinic.|Patients started with a conjunctival biopsy prior to enrolling in the study. Following biopsy, for one week, patients were discontinued on antiinflammatories and given only topical antibiotic prior to the study treatment of topical cyclosporin.
743410|NCT00987415||
743411|NCT00987402|Patients undergoing surgery at AIC Kijabe Hospital recruited between January 2007 to November 2007|Patients who declined consent for participation were excluded, as were those undergoing a second procedure within 2 weeks of the first.
743412|NCT00987389||704 subjects were enrolled into the study and randomized to either plasma exchange or no plasma exchange, and randomized to receive either standard dose GC or reduced dose GC.
743413|NCT00987337||
743414|NCT00986999||
743415|NCT00986986|Recruitment was through the University of Hawaii, Hawaii Center for AIDS|
743416|NCT00986973|Patients with Classical PKU who were being followed at Children's Hospital of Philadelphia were recruited between 2010 and 2011. Study participation was presented during routine clinic visits and interested subjects were screened for eligibility. A flier was posted on PKU support group websites help recruit additional subjects.|Six adults (4 male and 2 females) were interested in participating in the study, each signed informed consent forms and were screened for eligibility. All six were enrolled.
743417|NCT00986960|no recruiting|no enrollment
743418|NCT00986947|20 participants were enrolled.|
743422|NCT00986674|This study was activated on September 11, 2009. The trial was suspended to accrual on December 17, 2010 after accruing 140 patients and accrual was subsequently terminated on April 19, 2011 due to excessive grade 5 events within 30 days of study registration.|
743423|NCT00986583|Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least 3 months and those who had never used statins were considered to be eligible for participation. We included patients scheduled for elective surgery (October 2009 between June 2010) in this comparative, prospective, nonrandomized study.|
743424|NCT00986570|Date of recruitment : 01-Sep-2009 to 09-Feb-2010 Location: Outpatient clinic; Cosmiatry, surgery and oncology unit, Department of Dermatology, UNIFESP, Sao Paulo, Brazil|
743425|NCT00986544|"From December 1, 2009 to December 31, 2010 patients were submitted to laparoscopic cholecystectomy in Hospital P.Colombo, Velletri, Italy; University of Rome La Sapienza- Polo Pontino, Terracina, Italy; Obafemi Awolowo University, Ile-Ife, Nigeria."|Patients with acute cholecystitis, cholangitis, or pancreatitis were excluded. If intraoperative common bile duct exploration or any other additional procedure were performed, patients were also excluded
743426|NCT00986479|A total of 27 patients were enrolled. Of these, 22 patients were randomized to either: (1) AZD6765 (150 mg) followed by placebo or (2) placebo followed by AZD6765 (150 mg) in a crossover study design. A total of 20 patients completed both treatment periods of the study.|Screening for eligibility and washout of restricted medications.
743427|NCT00986453|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.|
743428|NCT00986440|A total of 84 participants who met all inclusion criteria and no exclusion criteria were enrolled at 46 clinic sites in Europe. Of the 84 participants enrolled, 83 received treatment.|Participants who were randomized to treatment (CS-7017 0.5 mg or placebo) started treatment within 8 weeks of completing first-line therapy.
743429|NCT00986427|24 patients recruited.|
743430|NCT00986401||
743431|NCT00986362|"First subject was recruited on 10 Feb 2010 and last subject completed the study on 14 Dec 2011.
~24 study eyes (16 ocriplasmin, 8 placebo) were evaluated during the study. 22 subjects were enrolled in the study. 2 subjects were treated in both eyes."|
743432|NCT00986349||
743433|NCT00986310|The study was completed and the PI has left the institution without entering the results information. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.|
743434|NCT00986258|The enrollment of the first participant was on the 30 October 2009 and was prematurely terminated, due to slow recruitment, on 21 January 2011 (when the last subject completed the last follow-up examination).|The Trial had a duration of 13 weeks. The one week Observation Period did not involve dosing with Tapentadol. For Tapentadol analyses purposes the first 6 weeks of dosing with Tapentadol are reported as one period, Titration and Optimal Dose Period. The last 6 weeks on Tapentadol are reported as the Maintenance Period.
743435|NCT00986245|The first subject was enrolled in September 2009 and the last subject completed the study in December 2010.|A total of 82 patients with PD were enrolled in this study at two centers in Seoul, Korea.
743436|NCT00986232|"18 clinical sites in the United States
~Date first participant visit: 08-Apr-1999
~Date last participant visit: 03-Apr-2000"|
743437|NCT00986180||19 subjects either did not take medication or did not have verifiable drug exposure. 2 subjects were randomized in two different sites, information was included for only one site. 1 subject was randomized in error.
743438|NCT00986154||
743439|NCT00986102|217 patients were enrolled at sites in Malaysia, Indonesia, Singapore, Vietnam and Hong Kong.|217 patients were enrolled and 216 received study medication. 1 patient was enrolled but subsequently withdrew consent before receiving the study medication. 61 patients discontinued study medication prior to end of treatment.
743440|NCT00985985|Participants were recruited at the clinical site.|Of 781 screened participants, only 723 were randomized and remaining 58 were considered screening failures. Participants who smoked their first cigarette within 30 minutes after waking were considered as high dependence smokers while those who smoked their first cigarette after 30 minutes of waking were considered as low dependence smokers.
743441|NCT00985959|Total 101 participants (Phase I: 18 and Phase II: 83) were enrolled at multiple sites in Japan.|18 participants were enrolled and treated in Phase I. Total 89 participants were enrolled in Phase II (including 6 participants receiving 1.3 mg/m2 in the Phase I part). Of the 89 participants, 87 were received at least 1 dose of study medication. 2 participants were not treated.
743442|NCT00985946|This study actively recruited from April 2010 through May 2011 at a large cancer center in Wisconsin.|
743443|NCT00985907||Arms/Groups are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from our legacy system. Paper records were lost in a flood, so participants were only grouped electronically by which phase they were enrolled. The study was terminated and participants were not enrolled in Phase 2 part of the study.
743444|NCT00985829|all patients with Histologically proven basal cell carcinoma (BCC) entered the study.|"Exclusion Criteria:
~rodent ulcer morphea type positive anti nuclear antibody test history of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month pregnancy breast feeding age< 18 history of another therapeutic intervention for bcc during last 6 months"
743445|NCT00985790|A total of 599 subjects were enrolled in the study, and assigned to either the GSK2321138A Group (298 subjects) or the Fluarix Group (301 subjects). Duration of study was of approximately 6 months for each subject.|For demography and safety, results are presented as per the main study groups. For some outcome measures and where relevant, subjects as in these 2 main groups are split according to their priming status at study entry.
743446|NCT00985751||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
743447|NCT00985738|Between 2009 and 2011, 16 patients were enrolled in the study from the Urologic Oncology clinic and Outpatient Urology clinic.|Subjects who qualified for the study based on the eligibility criteria were randomized to a placebo or treatment arm. After approximately 90 days (± 10 days), patients returned to undergo 3D mapping biopsy as part of their management of prostate cancer and received the tests/procedures outlined in the study calendar.
743660|NCT00976248||
743661|NCT00976209||
743662|NCT00976183|The recruitment was from one location a private practice. The enrollment started on 01/15/2010. The recruitment was to be a two year time period.|
743448|NCT00985725||Subjects clinically stable on an anti-depressant were randomized (1:1) to LDX or placebo augmentation for 9 weeks. Double-blind LDX or placebo was administered orally as adjunctive therapy (20 to 70 mg per day, titrated over the initial 6 weeks), with the optimal individual dose being continued during a 3-week dose maintenance period.
743449|NCT00985712||
743450|NCT00985686||
743451|NCT00985673||
743452|NCT00985543||
743453|NCT00985517||
743454|NCT00985504||"Acute treatment period (1 week): Participants randomized to switch to 60 milligrams (mg) duloxetine once daily (QD) by mouth (po) or 10 mg escitalopram QD po.
~Optimization period (7 weeks): Participants given duloxetine or escitalopram in acute study period may optimize their QD po doses (60-120 mg duloxetine QD po; 10-20 mg escitalopram QD po)."
743455|NCT00985491||
743456|NCT00985465||A total of 218 subjects were enrolled (147 subjects in the Synflorix Primed Group and 71 subjects in the Synflorix Unprimed Group). A total of 210 subjects were vaccinated in the booster vaccination study (141 out of 160 from the Synflorix Primed Group and 69 out of 78 from the Synflorix Unprimed Group).
743457|NCT00985439||
743458|NCT00985426||
743459|NCT00985257||
743460|NCT00985231|This study was conducted at 25 sites, by 25 Investigators in the United States (US). First participant enrollment was 09/28/2009 and last participant exited the study 11/09/2009|272 participants (544 eyes) were enrolled in the study, 7 participants were ineligible at baseline, 265 participants were eligible. 259 participants (518 eyes) completed the study.
743461|NCT00985192||A total of 49 patients were enrolled between December of 2007 and November of 2009 from 18 participating sites including the University of California Los Angeles hospitals and clinics participating in the TRIO-US Network.
743462|NCT00985166|"17 clinical sites in the United States
~Date of first participant visit: 24-Aug-2000
~Date of last participant visit: 06-May-2002"|Prior to entering study, all subjects received primary dose of M-M-R II™ and Varivax™ at less than or equal to 12 months of age.
743463|NCT00985153|"35 clinical sites in the United States and 5 clinical sites in Canada
~Date of first participant visit: 12-Apr-2000
~Date of last participant visit: 11-May-2001"|
743464|NCT00985140|Patients who may be eligible for the trial will be approached by the Investigator and offered participation in the trial. During a clinic visit, the Investigator or co-Investigator will explain the study to the potential subject verbally, and will allow the potential subject ample opportunity to ask questions.|Patients will undergo the following procedures during the screening period: Medical Hx, H&P, Severity Weighted Assessment Tool (mSWAT) assessment, simulation/set-up for TSEBT, CT if needed, pruritus, hair, and nail assessment, standardized photos (global, nails, head: top, front, sides, back), and two 5 mm punch biopsies from an active MF lesion.
743465|NCT00985114||
743466|NCT00985088||Out of 1343 subjects enrolled in the study, 3 subjects did not receive any vaccination.
743467|NCT00985010|"Encephalopathic patients admitted at the Department of Internal Medicine of the General Hospital Dr. Darío Fernández Fierro after being stabilized at the Emergency Room"|They were consecutive patients males or females aged > 18 years, with hepatic encephalopathy.
743468|NCT00984867|First participant enrolled: 10 Oct 2009. Last participant last visit for 24-week period: 10 Mar 2011. 833 participants were enrolled, 452 randomized and 451 treated in 3 European countries, USA, Argentina and Mexico. Participants with T2DM who showed inadequate glycemic control (7.0% ≤ HbA1c ≤ 10.0% at randomization) on sitagliptin +/- metformin.|During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Participants eligible for the study were stratified according to use of metformin.
743469|NCT00984815|Up to 100 eligible participants were to be enrolled at 4 U.S. study centers (3 private practice rheumatology centers and 1 academic center) between September, 2009 and June, 2010.|Eligible participants, 40-80 years of age inclusive, expected to require daily administration of a non-steroidal anti-inflammatory drug (NSAID) for at least the coming 12 months were enrolled. Of the approximately 100 participants enrolled, it was expected that at least 30 would complete the 54-week treatment period.
743470|NCT00984698|Veterans were recruited from the Southern Arizona VA Health Care System, Mental Health Clinic, September 2009 to July 2011.|115 enrolled, 50 eligible, 7 withdrew prior to randomization (3 time commitment, 2 lost contact, 1 changed mind/unknown, 1 travel distance)
743471|NCT00984659|"The number of participants enrolled in the Protocol reflects the number of participants starting treatment in the Double-blind Treatment Period."|After Screening (Visit 1), the study commenced with a 2-week Run-in Period, during which participants were permitted to use albuterol and/or ipratropium as rescue medication. Eligible participants at Visit 2 were randomized to receive one of three treatments in the 6-week Double-blind Treatment Period.
743472|NCT00984620||
743473|NCT00984594|"All participants were recruited from the patient population at one of the investigative sites between 12 June 2009 and 5 May 2010.
~One subject was enrolled at 17 years, 7 months. A protocol waiver was approved by the Institutional Review Board and parental informed consent and assent of subject was obtained."|Patients were assigned to the treatment arm based on a randomization table. Enrolled patients excluded: Not fulfilling inclusion or exclusion criteria, withdrawal of consent. Enrolled patients were followed to completion unless lost to follow up. Of 4 enrolled, 1 withdrew consent, 1 was lost to follow up & 2 completed
743474|NCT00984568||
743475|NCT00984542|This study opened to accrual in September 2009 and closed to accrual in February 2012|59 patients consented, 9 were determined to be ineligible to participate
743476|NCT00984490|This study recruited patients from September 24, 2009 through June 28, 2011.|Five patients enrolled on this study during the first nine months. Accrual continued to be slow causing its premature closing.
743477|NCT00984334||
743478|NCT00984308||
743479|NCT00984295|"48 clinical sites in the United States
~Date first participant visit: 27-Jun-2000
~Date last participant visit: 23-Oct-2001"|
743480|NCT00984282||Of 556 screened participants, 137 failed screening, 207 were randomized to receive sorafenib, 210 were randomized to placebo.
743481|NCT00984256|Study subjects were healthy male and non-pregnant or lactating females between the ages of 18 and 50 with a body mass index (BMI)between 19 and 30 for subject receiving the drug.|
743482|NCT00984204||
743483|NCT00984165||
743484|NCT00984139||
743485|NCT00984126|The subjects were enrolled at 52 sites in 19 countries:Brazil (4 sites), Croatia (2), Germany (3), Israel (1), Italy (2), Japan (5), Latvia (1), Lithuania (1), Macedonia (1), Malaysia (1), Poland (2), Russian Federation (2), Serbia (5), Spain (2), Switzerland (1), Taiwan (1), Turkey (5), the United Kingdom (1) and the United States (12).|Subjects completing 1 of the trials NN7008-3543 (NCT00840086),NN7008-3545 (NCT01138501),NN7008-3600 (NCT01238367),NN7008-3893 (NCT01365520) and NN7008-4015 (NCT01692925) could continue treatment with turoctocog alfa in the extension trial (NN7008-3568). Both new subjects and those from main trial (NN7008-3568) could enter the on-demand sub-trial.
743486|NCT00984061|Twenty-four (24) healthy, non-smoking, adult male and female volunteers, consisting of members of the community at large, were enrolled.|56 subjects screened, 32 were screen failures
743487|NCT00984022||
743488|NCT00984009|Twenty-two (22) healthy, non-smoking, non-obese, adult, male and female volunteers, consisting of members of the community at large, were enrolled in the study.|46 subjects screened, 13 were screen failures, 6 had schedule conflicts or were no shows for check-in, 1 was not screened per request of study site, 2 were transferred to a different study
743489|NCT00983983||4 participants were screened but excluded due to not meeting inclusion criteria (1 due to history of Myocardial Infarction, 1 due to Diabetes, 1 due to low forced vital capacity, and 1 due to the investigator's judgment).
743490|NCT00983957||A total of 47 participants were enrolled; 20 were treated. Reasons 27 participants were not treated: 21 no longer met study criteria, 2 withdrew consent, and 4 other reasons.
743491|NCT00983931|Twenty-four (24) healthy, non-smoking, male and female volunteers, consisting of volunteers from the community at large, were enrolled in the study.|41 subjects were screened, 11 were screen failures, 4 had schedule conflicts, 1 was transferred to a different study, and 1 was not needed
743492|NCT00983918|Recruitment from September 23, 2009 to March 9, 2010/|
743493|NCT00983905|Thirty (30) healthy, non-smoking, male and female volunteers, consisting of members of the community at large, were to be enrolled.|44 subjects screened, 6 were screen failures, 8 had schedule conflicts
743494|NCT00983892|This was a five year study from October 1 2009 to Sept 30 2014. Patients were recruited from three VA oncology practices: Ann Arbor, Fargo, and Loma Linda.|
743495|NCT00983853||
743496|NCT00983827||
743497|NCT00983801||Of 58 participants enrolled in this study, 6 failed screening criteria, and 52 received treatment.
743498|NCT00983749|This study enrolled 23 patients with symptoms and signs of acute middle cerebral artery (MCA) ischemic stroke presenting within 48 hours of onset at three academic medical centers in the United States.|Before randomization, all patients underwent duplex ultrasound scanning of the legs to rule out deep vein thrombosis (DVT), along with an assessment of temporal window adequacy for transcranial doppler (TCD); patients meeting these criteria were randomly assigned to one of two treatment arms (all the patients that were enrolled met these criteria).
743499|NCT00983645||
743500|NCT00983619||A total of 137 participants were screened, out of which 1 participant never received the study treatment. A total of 136 participants received study treatment.
743501|NCT00983580||
743502|NCT00983541||
743503|NCT00983528||Study enrolled six participants, but no participants completed study. Study was terminated due to slow accrual. All study data is reported by all participants since no data was analyzed due to study termination.
743504|NCT00983515|Twenty-four (24) healthy, non-smoking, male and female volunteers, consisting of members from the community at large, were enrolled in the study.|48 subjects were screened, 11 were screen failures, 7 had schedule conflicts, 6 were not needed
743505|NCT00983489|January 2009 to June 2010 Tertiary care neonatal unit|None excluded after enrolment. Those who did not follow up were not analysed.
743506|NCT00983476|Between February 2012 and April 2014, we obtained a list of individuals at the study site who met inclusion criteria for psychiatric diagnosis, age, and psychotropic medication. Study flyers were also posted in mental health clinics. 1429 individuals were screened for eligibility, and 19% were eligible, interested, enrolled, and randomized.|7 patients were withdrawn by the PI when they were determined to be ineligible, after signing a consent. Ineligibility reasons included: not being prescribed inclusion criteria medication, not receiving approval from primary care physician, non-veteran status, and unable to consent to participation. 2 patients disenrolled prior to group assignment.
743507|NCT00983437|Of patients with excessive sleepiness associated with mild or moderate traumatic brain injury (TBI) who had completed study C10953/3067/ES/MN (NCT00893789) and were considered to be eligible for enrollment into the current study, 49 patients at 25 centers in the United States were enrolled. No new patients were screened for the study.|Of 49 participants enrolled, 2 were withdrawn before taking any study drug for reasons of protocol violation and noncompliance with study procedures, respectively.
743508|NCT00983385|The trial started on 30 September 2009 with enrollment of the first subject and the last follow-up examination took place on 06 July 2010.|During the observation period (3 to 7 days in length) subjects recorded their analgesic medication intake and pain intensity. Prior to intake of tapentadol.
743509|NCT00983372|Twenty-four (24) healthy, non-smoking , male and female volunteers, consisting of members of the community at large, were enrolled in the study.|53 subjects were screened, 13 were screen failures, 14 had schedule conflicts, 1 transferred to a different study, and 1 was not needed
743510|NCT00983359|Patient recruitment period was June 2007 to March 2010|
743511|NCT00983346||
743512|NCT00983307||
743513|NCT00983294|Twenty-four (24) healthy, non-smoking, male and female volunteers, consisting of members of the community at large, were to be enrolled.|40 subjects screened, 6 were screen failures, 6 had schedule conflicts, 3 transferred to another study, 1 was not needed
743514|NCT00983281||
743515|NCT00983242|Twenty-four (24) healthy, non-smoking, adult male and female volunteers consisting of the community at large were enrolled.|Forty-four (44) subjects were screened, thirteen (13) were screen failures, five (5) were transferred to a different study, one (1) did not appear at check in at Period 1 and one (1) was not needed for the study.
743516|NCT00983216|Twenty-four (24) healthy, non-smoking, male and female volunteers, consisting of volunteers from the community at large, were enrolled in the study.|55 subjects were screened, 12 were screen failures, 7 had schedule conflicts, 1 was not used due to history of non-compliance, and 12 were not needed
743517|NCT00983073|The enrollment of the first participant was on the 21 September 2009 and was completed on 02 September 2010 (when the last subject completed the last follow-up examination).|The Trial had a duration of 13 weeks. The one week Observation Period did not involve dosing with Tapentadol. For Tapentadol analyses purposes the first 6 weeks of dosing with Tapentadol are reported as one period, Titration and Optimal Dose Period. The last 6 weeks on Tapentadol are reported as the Maintenance Period.
743518|NCT00982995||
743519|NCT00982878||
743520|NCT00982865|First/last subject (informed consent): December 2007/March 2012. Last subject completed: April 2016.|A total of 182 subjects entered the trial, of which 2 did not receive any treatment. 180 subjects received the study treatment and were included in the subject disposition table.
743521|NCT00982735||
743522|NCT00982657||The study was planned to be conducted in 2 phases, Phase 1b and Phase 2. On 23 Nov 2010, this study was closed to enrollment due to emerging clinical data which led to a re-assessment of strategic goals of the CVX-060 program. The study enrolled the Phase 1b portion only.
743523|NCT00982644|The trial was conducted at 166 sites in 12 countries: Austria (6 sites), Belgium (5 sites), Canada (17 sites), Czech Republic (5 sites), Denmark (6 sites), Finland (6 sites), France (7 sites), Germany (16 sites), Norway (8 sites), Serbia (5 sites), Spain (9 sites) and United States (76 sites). Some subjects did not enrol in the extension period.|All subjects who completed the 52-week main trial (NN51250-3579, NCT00982644) and when found to be eligible for the extension trial, were offered to participate in the 52-week extension trial (NN1250-3643). The total duration of treatment was up to 104 weeks (52 weeks + 52 weeks).
743524|NCT00982592|From October 2009 to February 2012, 124 patients were enrolled from multi sites to this study.|
743525|NCT00982553|"Recruitment was between 24/09/2009 and 29/10/2009.
~14 subjects were enrolled.
~The study took place at a specialist research unit at an National Health Service (NHS) hospital."|"Subjects were healthy volunteers.
~There was a 21 day washout for any prescribed and 7 days for over the counter medication before enrolment.
~The subjects were permitted to take paracetamol during the study but all others were excluded for the duration of the trial."
743526|NCT00982488||A total of 238 patients were enrolled: 200 with chronic phase chronic myelogenous leukemia (CML) and 38 with advanced phase disease (34 with acclelerated phase CML, 3 with myeloid blast phase CML, and 1 with Philadelphia chromosome positive acute lymphoblastic leukemia.) All but 1 CML patient, who no longer met study criteria, received treatment.
743527|NCT00982423|Subjects were recruited from outpatients being treated at the Mayo Clinic in Rochester, Minnesota.|There was 1 screen failure and 8 subjects withdrew prior to group assignment: 1 due to chest pain, 1 due to surgical procedure scheduled to take place during treatment phase, 1 due to fluid overload, 2 due to time constraints of work and family issues, and 3 due to primary physician-initiated medication titration.
743528|NCT00982410||
743529|NCT00982397||Twenty patients were excluded from analysis, because they did not meet the eligibility criteria; 1 patient did not sign consent, 1 patient participated in a confounding trial, 8 patients did not have an implant attempted, 5 patients failed implant, and 5 patients received a device other than the Protecta.Total enrolled=2790, total analyzed=2770
743530|NCT00982345||
743531|NCT00982319||
743532|NCT00982280|The enrollment of the first participant was on the 02 October 2009 and was prematurely terminated, due to slow recruitment, on 12 August 2010 (when the last subject completed the last follow-up examination).|The Trial had a duration of 13 weeks. The one week Observation Period did not involve dosing with Tapentadol. For Tapentadol analyses purposes the first 6 weeks of dosing with Tapentadol are reported as one period, Titration and Optimal Dose Period. The last 6 weeks on Tapentadol are reported as the Maintenance Period.
743533|NCT00982228|The trial was conducted at 79 sites in 6 countries: France (6), Germany (5), Russia (7), South Africa (3), United Kingdom (U.K.) (6) and United States (U.S.) (52).|All subjects who completed the 52-week main trial (NN1250-3583, NCT00982228) and were found to be eligible for the extension trial were offered to participate in the 52-week extension trial (NN1250-3644).
743534|NCT00982189||
743535|NCT00982137|Participants were screened and enrolled from 27 July 2004 to 27 September 2004 at 1 clinical center in Australia.|A total of 108 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
743536|NCT00982111||Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.
743537|NCT00982033||
743538|NCT00982020||
743539|NCT00982007|Hospitals and Medical Clinics|
743540|NCT00981825|At clinical site|
743541|NCT00981812|Recruited from 02/2010 to 06/2011 from University of Cincinnati Medical Center, Radiology Department, Breast Imaging.|
743542|NCT00981799||
743543|NCT00981747||
743544|NCT00981669|Recruitment period: From February to August 2009.79 healthy adult volunteers from 18 to 40 years of age were selected. Participants were screened for eligibility and enrolled by the investigators following the signing of an informed consent. Due to a recommendation from ANVISA, female volunteers were not allowed to be recruited.|98 potential volunteers were interviewed, 80 of them were enrolled: 40 volunteers were allocated to receive the investigational product (rotavirus vaccine) and 40 were allocated to receive placebo; 79 completed the follow-up. Before randomization 18 volunteers were excluded, 3 refused to participate and 15 had screening failure
743545|NCT00981630|Participants were enrolled from 01 December 2004 to 31 January 2005 at 2 clinical centers in Australia.|A total of 128 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
743546|NCT00981578|The protocol was approved to treat 50 participants at up to six sites. The study was closed by the Sponsor after treating 17 participants at five sites.|Of the 37 subjects enrolled (signed consent), 11 subjects failed additional study requirements and 9 subjects exited the study prior to treatment. Seventeen subjects received the study Exablate treatment.
743547|NCT00981526||A total of 66 subjects were screened, 4 of which were screen fails. 62 subjects were then enrolled. Prior to randomization, 8 subjects withdrew consent. 54 subjects were randomized.
743663|NCT00976027|Participants were enrolled in the study from 22 September 2009 to 07 November 2009 at 99 clinical centers in the US.|A total of 9158 of the 9172 participants that were randomized were vaccinated, evaluated, and reported in this report.
743548|NCT00981461|This double-blind, device controlled 26 week study was recruited at 6 clinical study sites. The recruitment period was from October 29, 2008 to March 2, 2009|Key exclusion criteria was pregnancy, malignancy in target area, an no hair transplants, scalp reductions, or hair weaves. Active hair loss less than 12 months.
743549|NCT00981435||
743550|NCT00981409||
743551|NCT00981370|Subjects recruited from local physicians and at CHLA.|No groups for this study.
743552|NCT00981305||
743553|NCT00981292||
743554|NCT00981253|Overall, 164 participants were consented for study participation. Of these, 151 participants were randomized to either Standard Cardiac Rehabilitation or SMT-Enhanced Cardiac Rehabilitation. Post-intervention assessments were completed on 145 participants; 151 participants were available for intention-to-treat analysis.|
743555|NCT00981227|"First subject enrolled 06 November 2007; Date last subject completed: 19 January 2009.
~Number of subjects:
~Planned: 540 subjects (90 in each of the 6 treatment groups). Randomised and treated: 567. Analysed for efficacy (per-protocol): 396 Analysed for safety: 567."|An up to 2-week baseline was followed by a 1-week titration period, an 8-week maintenance period, and a 2-week safety follow-up period. If subjects had a creatinine clearance between 30 and 60 mL/min, they received half of the assigned dose, and subjects with a creatinine clearance below 30 mL/min were not enrolled in this study.
743556|NCT00981214||
743557|NCT00981175|Participants were enrolled and vaccinated from 14 April 2003 to 05 January 2004 at 1 clinical center in Australia.|A total of 202 participants who met the inclusion/exclusion criteria were enrolled and vaccinated. A subset of the participants also received a booster vaccine at month 6. A report on all participants who received the primary and booster vaccination and the primary vaccination only are presented.
743558|NCT00981149||
743559|NCT00981084|Participants who demonstrated at least mild cognitive impairment on a screening measure were recruited from a large MS neurology clinic in the Midwest from 2009 to 2011.|
743560|NCT00981058||Participants who completed the study include those who died due to any cause or were alive and on study at conclusion, but off treatment.
743561|NCT00981045|04-Sept-2009 through 15-Jun-2011; Hospitals and Medical Clinics|14 subjects randomized to FCM and 9 subjects randomized to Venofer were discontinued prior to dosing due to subject request or selection criteria/study compliance reasons.
743562|NCT00981019|Sample frame is the Harris Interactive Physician Panel Harris Interactive AG will draw a simple random sample U.S. internal and family medicine physicians from their Physician Panel and e-mail them an invitation and a link to the online-survey|Inclusion criteria: Physicians in internal, family and general medicine. Exclusion criteria: All physicians other than internal, family and general medicine physicians are excluded from participation because these usually are not offering cancer screening to there patients in the setting of primary care
743563|NCT00980980|45 out of 165 Hospital Corporation of America (HCA) hospitals were recruited for this trial of adult ICUs. There was a 12-month baseline period from January 1 through December 31, 2009; a phase-in period from January 1 through April 7, 2010; and an 18-month intervention period from April 8, 2010 through September 30, 2011.|74,256 patients were involved in the intervention period among adult ICUs from the 43 participating hospitals. Routinely collected information for about 48,390 individuals cared for during the baseline period was used for comparison to the experience of the patients in all three arms of the Intervention period.
743564|NCT00980798|The first subject attended the first study visit on 05 October 2007, and the last subject completed the last study visit on 24 November 2008.|
743565|NCT00980785|Participants were recruited from the Wisconsin Alzheimer's Disease Research Center (ADRC) registry and from the community for the clinical trial, Studying the Effects of Antihypertensives in Individuals at Risk for Alzheimer's (SEAIRA).|
743566|NCT00980746|Date first subject enrolled: 06 Nov 2007 Date last subject completed: 18 Nov 2008 Randomised and treated: 557. Analyzed for efficacy (per-protocol [PP]): 403. Analyzed for safety: 557.|During the 2week baseline period,current neuropathic pain drug therapy was discontinued and subjects had to be free of any medication that could affect efficacy(except authorized rescue medication)for 2weeks before start of double-blind study treatment.In case of unbearable pain, this drug-free period could be reduced,but had to be at least 7 days.
743567|NCT00980681|The recruitment started in Sept 2009 and stopped in February 2010. Radiology departments from hospital or private practices were participating.|Out of the 13 enrolled patients, three did not receive treatment, mainly due to the Sponsor decision to interrupt the study
743568|NCT00980655||
743569|NCT00980642|Patients having trauma surgery with general anesthesia were recruited from the University of Vienna, while patients having orthopedic surgery with regional anesthesia were recruited from the Cleveland Clinic from January 2009 to June 2011.|
743570|NCT00980590||
743571|NCT00980395||
743572|NCT00980343|Subjects were enrolled from March 2010 to April 2011. Subjects were recruited from outpatient cancer centers but all patients needed surgery to participate in this study.|
743573|NCT00980330|The study was conducted at 89 sites in 14 countries.|A total of 618 participants were screened. Of these, 463 participants were randomized of whom 462 participants started treatment. One participant in the placebo group was 'randomized in error,' did not receive treatment, and was withdrawn from the study due to non-compliance (did not come for visit).
743574|NCT00980278||
743575|NCT00980200|Participants (par,) who met all inclusion criteria at screening entered a 7-day Run-in Period (RIP). Par. were instructed to administer albuterol inhalation aerosol as needed and to continue their inhaled corticosteroid at a stable dose throughout the study. Par. who met randomization criteria at the end of the RIP entered Treatment Period 1.|The study was a multi-centre, double-blind, placebo-controlled, five-period cross-over study. Following the 7(+7)-day RIP, eligible participants were randomized to 1 of 5 sequences of GW642444 at doses of 6.25 micrograms (µg) once daily (QD), 6.25 µg twice daily, 12.5 µg QD, 25 µg QD, and placebo.
743576|NCT00980174||
743577|NCT00980148||
743578|NCT00980057||"Total number of:
~522 pts enrolled, 1 exit
~521 pts with baseline information, 16 exits
~505 pts of which 14 unsuccessful implants and 491 successful implants, 12 exits and 1 death
~478 randomized (318 to aCRT, 160 to control)"
743772|NCT00969878||
748713|NCT00721500|There were 25 subjects enrolled to the study.|Subjects were enrolled per inclusion/exclusion criteria and randomized to a study arm.
743579|NCT00980044|Outpatient screening. Recruitment by advertisement and word or mouth.|"Persons screening who did not meet inclusion/ exclusion criteria were not enrolled.
~Persons who did not complete the study were not included in analyses. The study was designed as an efficacy study that a priori stated it would enroll until 12 persons in each group completed the study and analyse only completers. No serious AEs in noncompleters."
743580|NCT00980005||Subjects were stratified by age-strata: 3-4, 5-8 and 9-17 years and received vaccine according to their priming status: primed subjects received a 2-dose priming immunization in a previous season, whereas unprimed subjects had not. Blood samples: at Days 0 - 28 for primed subjects and subjects 9-17 years and at Days 0-56 for unprimed subjects.
743581|NCT00979992|The study was activated on 4/9/2010 and closed to accrual on 9/30/2013.|
743582|NCT00979953||
743583|NCT00979940||
743584|NCT00979901|"Patients were recruited at 50 sites (43 in the US and 7 in Canada).
~Primary Therapy Period: March 2000 to July 2000."|Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime nasal symptoms score during the run-in period were excluded from randomization.
743585|NCT00979875||
743586|NCT00979810||
743587|NCT00979654||A total of 118 participants were Screened out of which 15 participants did not meet eligibility criteria and were considered screen failures, and 103 participants were entered into the study.
743588|NCT00979628|375 subjects were enrolled in the study from January 2010 to June 2012. The study is conducted in 3 states and patients were enrolled from 3 hospitals in state of Georgia; 1 hospitals in south Carolina and 1 hospitals in Texas.|24 subjects that were consented were withdrawn from the study and not included in analysis because they meet exclusion criteria like transferring to ICU; receiving treatment < 24 hrs and for receiving steroids
743589|NCT00979615|September 9, 2009 - November 13, 2009|
743590|NCT00979602||
743591|NCT00979576||19 patients were enrolled in the study however one patient did not meet the inclusion criteria and therefore did not participate in the study.
743592|NCT00979550||
743593|NCT00979459||
743594|NCT00979420||
743595|NCT00979407||Out of 336 subjects enrolled in the study, 2 subjects did not receive any vaccination.
743596|NCT00979303||
743597|NCT00979212||
743598|NCT00979199||
743599|NCT00979147||PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
743600|NCT00979134|First patient enrolled: 21 October 2009 and last patient enrolled: 13 December 2013. This was a multicentre study conducted at a total of 29 centres in 7 countries.|In Parts A and B, a single dose was followed by a Washout Period of 5 to 10 days before multiple dosing commenced.
743601|NCT00979121||
743602|NCT00979069||
743603|NCT00979017||
743604|NCT00978757||
743605|NCT00978731||
743606|NCT00978627|The trial was conducted at 79 sites in 9 countries: Denmark (3 sites), Poland (6 sites), Romania (8 sites), France (3 sites), United Kingdom (8 sites), Russian Federation (11 sites), Israel (4 sites), Australia (7 sites), and United States (29 sites). Some sites did not enrol subjects in the extension period.|The total duration of treatment was up to 52 weeks (26 weeks [main trial: NN5401-3594, NCT00978627] + 26 weeks [extension trial: NN5401-3645]), separated by 1 week of wash-out period; during which subjects were treated with Neutral Protamine Hagedorn (NPH) insulin twice daily (BID) in combination with insulin aspart.
743607|NCT00978562||
743608|NCT00978445|Inrolled 25 patients in two arms of 12 weeks from patient population of Cleveland Clinic Foundation|Clear enrollement criteria were created only real exclusion was if physician did not believe patient could perform protocol and if outside of age criteria.
743609|NCT00978432|The study opened to enrollment in October, 2009. 50 subjects were consented until enrollment closure in April 2015. Patients were recruited at the Duke Cancer Center Hematology clinic.|Fifty (50) participants signed consent. Eleven subjects were screen failures. The PI removed three subjects prior to treatment to receive alternate therapy. Three subjects chose to withdraw from the study prior to treatment.
743610|NCT00978419||Both Principal Investigators left Vanderbilt without completing record. Have been unable to find any records from this study or publication. Total enrollment and completion date are from IRB records.
743611|NCT00978380|The trial was conducted at 34 sites in 12 countries as follows: Austria: 1 site; Canada: 1 site; Finland: 1 site; France: 4 sites; Germany: 4 sites; Israel: 1 site; Italy: 1 site: Japan: 2 sites; Spain: 2 sites; Switzerland: 1 site; United Kingdom: 4 sites; United States: 12 sites.|Subjects who completed F13CD-1725 (CT.gov identifier: NCT00713648) end of trial visit were eligible to enroll in this trial. Also, new subjects diagnosed with congenital FXIII A-subunit deficiency (confirmed by genotyping at screening visit or documented results from previously performed genotyping) were enrolled to expand the safety population.
743612|NCT00978341|Subjects were enrolled at 4 study centers and participated in the study between 13 February 2007 and 01 October 2008.|Subjects completed a 1-2 week screening period to determine eligibility criteria prior to enrollment. Of 24 subjects screened, 15 subjects were enrolled into the study and randomized.
743613|NCT00978250||
743614|NCT00978120|Study participants were recruited from October 16 to November 13, 2009 at the seven National Heart, Lung, and Blood Institute (NHLBI)- funded Severe Asthma Research Program sites.|
743615|NCT00978068|Children were recruited from September 2009 through July 2011.|"A total of 404 children were screened for eligibility; 228 were found not to be eligible. The main reasons for ineligibility were:
~136 Were not eligible for ART 34 Were on ART with detectable viral load 32 Were HIV- 8 Had not received ART but had prior exposure to nevirapine"
743616|NCT00978042|345 participants were originally recruited for treatment at 15 sites.|"Prior to randomization, 16 patients were excluded as screen failures and the first two participants per site (30 total) were treated as run-in participants. Of the 299 randomized participants, 17 were discontinued prior to treatment, leaving a modified intent-to-treat population of 282 participants (235 in Treatment Arm and 47 in Control Arm)."
743617|NCT00978029||Due to non-compliance with Good Clinical Practice (GCP) 7 randomized participants who completed treatment were excluded from all subsequent analysis.
743881|NCT00963807||
743618|NCT00977938|Between 08/13/2009 and 07/01/2011, a total of 25682 patients were enrolled into the DAPT Study either by HCRI (NCT00977938; 14491 pts) or from 1 of 4 PMS studies: Abbott Xience V US (NCT01106534; 2998 pts), Boston Scientific Liberté PAS (NCT00997503; 3904 pts), Cordis CYPRESS (NCT00954707; 2029 pts) and Medtronic EDUCATE (NCT01069003; 2260 pts).|
743619|NCT00977808||
743620|NCT00977769||
743621|NCT00977704||
743622|NCT00977691||
743623|NCT00977665||Eligible participants were randomized in a 1:1 ratio to either active treatment or placebo.
743624|NCT00977613|Enrolled subjects were ambulatory patients completing treatment for colorectal cancer (CRC) from April 2007 through August 2009 at the Continuum Cancer Centers-Beth Israel Medical Center and St. Luke's Roosevelt Hospital.|Subjects were counseled to exercise at least 18 metabolic equivalent units weekly. Subjects were provided with information on the metabolic equivalents of common forms of exercise.
743625|NCT00977574|Accrual of 349 patients from 48 main members and CCOP sites began on 9/14/2009 and completed on 01/09/2012 in 28 months; 5 months longer than expected. There were 11 patients deemed ineligible by central review most for reasons related to pathologic diagnosis. Ten patients refused all protocol treatment.|
743626|NCT00977561||
743627|NCT00977548|Between September 2009 and January 2011, 39 patients signed consent at Moffitt Cancer Center.|4 of the initial 39 patients were found to be ineligible after signing informed consent.
743628|NCT00977470||
743629|NCT00977431|This is phase I, open-label, non-randomised, uncontrolled dose-escalation trial using a rule-based 3+3 design and patient stratification to explore safety of combining afatinib and radiotherapy with or without temozolomide in newly diagnosed Glioblastoma multiforme (GBM)|All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
743630|NCT00977379||
743631|NCT00977314|Recruitment/Enrollment Phase(September 2009-November 2009) Location: Medical Clinics Meant to assess the subjects' ability to be enrolled in the trial, included Medical, Audiological and Dental evaluations.|Phase 1: Enrollment: Assesses the subjects' ability to be enrolled in the trial. It included medical, audiological, and dental evaluations and device fit to ensure comfort during the duration of the trial.
743632|NCT00977197||
743633|NCT00977184||
743634|NCT00977171||
743635|NCT00977106||
743636|NCT00977080||Of the 272 participants enrolled in the study, 4 did not receive study drug and were not included in the population analyzed.
743637|NCT00976989|This study included 3 periods: Neoadjuvant (pre-operative) period and surgery, adjuvant (post-operative) period and post-treatment follow-up period.|
743638|NCT00976950||
743639|NCT00976937|The study was conducted at 92 centers in 13 countries between August 31, 2009 and March 19, 2011.|A total of 620 patients were screened of which 301 (48.5%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 319 patients were randomized.
743640|NCT00976911||
743641|NCT00976898||
743642|NCT00976820||Out of the 323 subjects originally enrolled in the study, 1 subject was not included in the Total Vaccinated Cohort.
743643|NCT00976716|Subjects were screened at 12 centers in Japan.|
743644|NCT00976703|We performed a single-site randomized controlled trial at MetroHealth Medical Center, a tertiary hospital, from December 2009 to July 2012.|Eligibility criteria included: admission for an induction of labor, a fetus in cephalic presentation, and an unripe cervix defined as a Bishop score ≤ 6.
743645|NCT00976677|This study opened to accrual on January 27, 2010 and was terminated on May 13, 2011 due to slow accrual. Final accrual was 10 patients.|
743646|NCT00976664|We recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area.|143 people were screened by phone, eligible patients (58) attended a baseline visit. Subjects were eligible if they were 18+ years of age and symptomatic with pain between T12-S1 joints with or without radiating pain for at least 3 months. Patients were randomized to a treatment group receiving custom-made orthotics or a wait-list control group.
743647|NCT00976599||
743648|NCT00976573||
743649|NCT00976560|The study was conducted between 25 Sep 2009 to 7 July 2010. The study was conducted at 21 centers in 5 countries (Bulgaria [4], Estonia [1], Germany [7], Russia [5], United States [4]).|A total of 128 participants of both the gender, with major depressive disorder (MDD), having at least one previous major depressive episode in history and currently undergoing a recurrence, of age group 18 to 60, were enrolled globally. A total of 231 participants were screened of which 103 were screen-failures.
743650|NCT00976521|Between 28-Nov-09 and 02-Dec-11, 452 subjects meeting all clinical eligibility criteria were consented and enrolled at 37 US and European sites.|Subjects were randomized in a 1:1:1:1 ratio to each of the randomized groups (abciximab infusion with aspiration, abciximab infusion without aspiration, no infusion with aspiration, no infusion without aspiration).
743651|NCT00976508||
743652|NCT00976495|Of 154 participants enrolled, 77 completed a qualification period. Of these 77 participants, 75 were randomized and received treatment. Of these 75 participants, 74 completed double-blind treatment period.|
743653|NCT00976482||
743654|NCT00976456||
743655|NCT00976404||
743656|NCT00976391||Participants (par.) who met eligibility criteria and completed a 4-8 week Run-in/Stabilization Period were then randomized to a 52-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 920 par. were screened; 586 par. were randomized, and 566 par. received >=1 treatment dose.
743657|NCT00976352|Subjects were recruited from the Pediatric Neuromuscular Disorders Clinic at the University of Florida. Subjects were also self-referred from the ClinicalTrials.gov listing.|All subjects underwent a screening process for eligibility determination as well as for safety evaluations.
743658|NCT00976339|Referrals to the Columbia breast oncology clinic for breast cancer chemoprevention will be recruited medical oncologist or via recruitment flyers. Recruitment letters will be sent to high-risk women who participated in the Metropolitan Breast Cancer Family Registry and Women at Risk (WAR) database.|
743659|NCT00976274||
743664|NCT00975975|This protocol has 17 patients. The study was stopped prior to 20 due to the meeting of a stopping rule of 5 or more deaths within the first 15 patients. An additional patient was enrolled after the stopping rule was met. This patient was followed for safety/AE but is not included in the analysis of the efficacy measures, as recommended by the IRB.|
743665|NCT00975923|Leaders of all medical centers with at least 1 adult or pediatric ICU received an invitation to participate in a Quality Improvement initiative. Hospitals willing to participate were matched on geographic location and ICU volume and then randomized into either the Collaborative or Tool Kit Group in December 2005.|
743666|NCT00975884||Out of 313 subjects enrolled in the study, 7 subjects did not receive any vaccination.
743667|NCT00975806||
743668|NCT00975780||
743669|NCT00975715|A total of 99 patients were randomized, one patient who did not receive study drug was excluded. A total of 48 participants were randomized to TRI476 and 51 to placebo. 7 participants discontinued during the titration period and 3 discontinued during the maintenance period. A total of 89 participants completed the study.|Participants kept same dosage of their traditional antiepileptics prior to screening and throughout the study. They received TRI476 or placebo in a 1:1 ratio. TRI476 dose was increased gradually, based on body weight during the titration period (day 0- 14). The tolerated dose was given during the maintenance period (up to day 56).
743670|NCT00975689||
743671|NCT00975650||
743672|NCT00975637||
743673|NCT00975611|Subjects were recruited from the Freedom Trail Clinic, MGH Schizophrenia Program|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen failed due to a positive drug screen.
743674|NCT00975585||
743675|NCT00975507|"2 clinical sites in the United States
~Date of first participant visit: 24-Mar-1998
~Date of last participant visit: 05-Jan-1999"|
743676|NCT00975481||
743677|NCT00975416|"Study was conducted at an inpatient treatment center. Screening was included in the study. Also, baseline characterization was done as a within subject study with tasks and measures before randomization to oxytocin or placebo and treatment with cognitive behavioral therapy.
~Methadone and outpatient cocaine arms did not recruit participants."|63 participants were screened, 30 were randomized. Subjects completed a battery of tasks and measures on oxytocin and on placebo before entering into randomized treatment phase where they were assisgned to the oxytocin or placebo arm with all subjects receiving cognitive behavioral therapy during the treatment phase.
743678|NCT00975286|The study was conducted at 140 centers in 25 countries between October 13, 2009 and August 01, 2011.|A total of 1470 patients were screened of which 1024 were screen or run-in failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 9%). A total of 446 patients were randomized.
743679|NCT00975221|"The study was conducted at 29 centers in United States, Australia, Canada, Hungary, Poland, Portugal, and Russian Federation.
~The first participant enrolled on 10 March 2010 and the last participant enrolled on 28 December 2011."|This study consisted of a 12-week placebo-controlled dose-titration phase, a 16-week placebo-controlled efficacy assessment phase (EAP), and an open-label safety extension phase for 24 weeks of cinacalcet treatment. Participants were randomized in a 1:1 ratio to cinacalcet or placebo stratified by bisphosphonate use.
743680|NCT00975195||
743681|NCT00975156||
743682|NCT00975143|The study was performed at 49 investigational centers in the United States and Canada. Of the 1265 patients screened for the study, a total of 925 were randomized to CIP-Isotretinoin (N=464) or generic Isotretinoin (N=461) between October 2009 and October 2010. Randomization was stratified by gender and study site.|Reasons for screen failure: patient's decision (83 pts), low disease severity (61), entry criteria (51), psychological disqualification (44), lost to follow-up (33) and low vitamin D levels (33). Washouts were specified for: systemic corticosteroids, spironolactone (30 d), other acne treatment, phenytoin (14 d), topical corticosteroids (7 d).
743683|NCT00975130||
743684|NCT00975000|"This study was conducted at 33 centers in 11 countries (Australia, Austria, Belgium, Canada, France, Germany, Italy, Poland, Spain, Switzerland, and USA).
~First patient enrolled on 15 October 2009 and last patient enrolled on 07 March 2012."|The study consisted of a 20-week titration phase, a 6-week efficacy assessment phase (EAP), a 26-week blinded maintenance phase and a 4-week follow-up phase. Randomization was stratified by corrected total serum calcium (Ca); enrollment into the low Ca stratum was limited to ≤70% of patients to ensure at least 30% enrollment in the high Ca stratum.
743685|NCT00974974|Study period was form September 29, 2009 to January 19, 2011.|Prior to randomization, subjects needed to complete a 3-week dose adjustment of IR CD-LD followed by 6-week dose conversion to IPX066.
743686|NCT00974922|Study initiated in 2010, study terminated prematurely by the sponsor in December 2011.|
743687|NCT00974818||
743688|NCT00974675||
743689|NCT00974571|"74 study sites in the United States
~Primary Therapy: Nov-2001 to May-2002"|Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime rhinitis symptoms score during the run-in period were excluded from randomization.
743690|NCT00974493||
743691|NCT00974480|Subjects were recruited from September 2009 to January 2010 at a research clinic.|
743692|NCT00974376||
743693|NCT00974363|Out of the 697 subjects enrolled in this study, only 689 were vaccinated and hence started the study.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
743694|NCT00974311|A total of 1199 participants were enrolled and randomized for double-blind (DB) phase. Out of which, 159 participants entered the optional open-label extension (OLE) phase.|Participants were randomized 2:1 to receive either Enzalutamide or Placebo in DB phase. All participants who continued in OLE phase, received Enzalutamide.
743695|NCT00974259|Patients with severe TBI who required ICP monitoring were screened at 10 Level 1 trauma centers . Patients admitted with an initial GCS greater than 8 who deteriorated neurologically (within 48 hr of injury) from a presumptive could also be enrolled provided randomization and ICP monitor placement occurred within 12 hours of deterioration.|
743696|NCT00974246||
749112|NCT00703326||Participants who were alive and completed the follow-up period or who died were considered to have completed the study.
743697|NCT00974233|Research subjected from the University of Wisconsin and 7 Wisconsin Oncology Network institutions were enrolled from October 2009 to November 2011. Subjects were enrolled from outpatient hematology clinics at each participating institution.|
743698|NCT00974220|Recruitment took place between February and October 2010. Subjects were recruited from respiratory outpatient clinics and from a database of subjects who had previously taken part in research studies in COPD.|"No enrolled subjects were excluded prior to group assignment.
~7 subjects were assigned a treatment order of fentanyl-placebo (2 were withdrawn after period 1) and 9 subjects were assigned a treatment order of placebo-fentanyl (2 were withdrawn after period 1). Therefore, there was complete data from 12 subjects."
743699|NCT00974142|Patients were recruited from local clinics, advertisement, and a disease specific registry|772 patients underwent initial screening and 43 were eligible to sign consent. These patients underwent a second 2 week screening process and 17 subjects met all criteria for randomization
743700|NCT00974090||
743701|NCT00974051|Recruited from the Barbara Davis Center pediatric population|no notes
743702|NCT00973973|Participants were enrolled at 37 centers in the United States.|The study consisted of up to 8 weeks of screening with data collection to establish baseline pain, an 8-week double-blind placebo-controlled treatment period, a 16-week open-label treatment period with all patients receiving elagolix 150 mg once per day, and a 6-week posttreatment follow-up period.
743703|NCT00973921||
743704|NCT00973856||There were no pre-assignment details. Once consented, pts were enrolled into both study arms.
743705|NCT00973765|July 1, 2008 - June 1, 2009 in emergency department|
743706|NCT00973752||
743707|NCT00973739|Twenty-one patients were enrolled between October 2009 and March 2011 at New York University Medical Center.|
743708|NCT00973700|Participants were enrolled at one center in Costa Rica.|All enrolled subjects were included in the trial.
743709|NCT00973674|Clinical sites enrolled men and women age 18 to 55 who experienced severe traumatic brain injury in the EMS setting between September 2009 and January 2012.|
743710|NCT00973622|Participants were recruited from 11/4/2009 to 9/19/2011 from the surrounding community using primarily newspaper advertisements and word of mouth.|Enrolled participants were scheduled for an MRI of the head and needed to pass the MRI-screen (i.e., have no significant brain abnormalities) to continue with the study. Of the 49 participants who obtained an MRI, 6 participants did not pass this screen.
743711|NCT00973479|This study evaluated the efficacy and safety of intravenous administration of Golimumab 2mg/kg + methotrexate (MTX) in patients with Active Rheumatoid Arthritis despite treatment with MTX therapy. It was conducted between 14 September 2009 and 08 February 2013 and recruited participants at 92 sites in 13 countries worldwide.|592 participants were randomly allocated to 2 treatment arms. At Week 16 some participants in Placebo arm switched to Golimumab earlier than the rest at Week 24. Thus, the Adverse Events are presented based upon the time when participants began to receive Golimumab in the following manner: Golimumab from Day 0, from Week 16 and from Week 24.
743712|NCT00973362||
743713|NCT00973349|Participants were enrolled at 21 sites in the US.|
743714|NCT00973102|Clinical sites enrolled men and women age 18 to 55 who experienced hemorrhagic shock in the emergency medical services (EMS) setting between September 2009 and January 2012.|
743715|NCT00972959||
743716|NCT00972816|36 centers in the U.S., of which 34 centers enrolled subjects.|
743717|NCT00972777|This was a two phase (IIB/III) integrated study. Phase IIb was conducted at 31 sites and Phase III at 28 sites in the United States. The first participant was enrolled in phase IIb on 10/30/2009, and last participant exited the study on 04/09/2010. Phase III enrolled its first participant on 04/05/2010 and last participant exited on 10/13/2010.|A total of 474 participants were enrolled in the integrated study in the intent to treat(ITT) population. 276 participants had culture confirmed bacterial conjunctivitis and were assigned to the modified intent to treat(mITT) population. 464 participants were assigned to the safety population. 446 participants completed the study.
743718|NCT00972738|"Thirty-two study sites in Canada and the United States.
~Primary Therapy Period: Apr-2001 to Jul-2001."|Patients who required certain medications as described in the protocol and those who did not meet a minimum predefined level of combined daytime nasal symptoms score during the run-in period were excluded from randomization.
743719|NCT00972725||Out of all the subjects planned for enrollment, only 28 were included in the analyses and hence started the study.
743720|NCT00972621|Subjects were recruited from the general cataract populations from 11 ophthalmic practices between September 2009 and July 2010.|Enrolled participants who did not meet the inclusion/exclusion criteria as detailed in the protocol were excluded from the trial prior to assignment to study group. Randomization assigned199 Vitrax II subjects and 201 Viscoat subjects, but a randomization error (Viscoat (control) subject treated with Vitrax II) resulted in 200 subjects per group.
743721|NCT00972595||
743722|NCT00972543|"Date of first subject's first visit: 29 Sep 2008 Date of last subject's last visit: 25 May 2009 Subjects were screened at 3 centers in Australia, of which 2 centers enrolled subjects.
~It was planned to conduct the trial in centers in Australia and Latin America; however, the trial was terminated before most centers were initiated."|Screening was performed within 2 weeks prior to starting trial treatment.
743723|NCT00972530||
743724|NCT00972517|"One subject was enrolled but not vaccinated and therefore, was not included in the number of subjects under STARTED"|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
743725|NCT00972504|From June-2009 to August-2009, total of 54 participants were randomized at one site in Germany.|All participants had a diagnosis of seasonal allergic rhinitis and exhibited a moderate response to allergen challenge in the environmental challenge chamber (ECC) at Screening, defined as total nasal symptom score (TNSS) more than equal to (>=) 6.
743726|NCT00972478||
743727|NCT00972439|Recruitment dates: April 2008 - October 2008 Ob/gyn clinics|
743728|NCT00972374||
743729|NCT00972335||
743730|NCT00972322|This was a multicenter study in 5 clinical centers in the United States.|
743909|NCT00962065|This was a single-center trial in the United States, with 1 investigator participating.|There was a 14-day washout period and a 5-day diet stabilization period prior to randomization.
743731|NCT00972283|The trial was conducted at 123 sites in 12 countries: Bulgaria (8 sites), Germany (8), Hong Kong (1), Ireland (4), Italy (11), Romania (5), Russia (6), Slovakia (4), South Africa (5), Spain (9), Turkey (3) and the United States (U.S.) (59). Some sites did not enroll subjects in the extension period. One site from United States was closed.|All subjects who completed the 52-week main trial (NN1250-3582, NCT00972283) and were found to be eligible for the extension trial were offered to participate in the 26-week extension trial (NN1250-3667). The total duration of treatment was up to 78 weeks (52 weeks + 26 weeks).
743732|NCT00972244|Enrollment: 417; randomized: 279 Study Start Date: August 2009 Study Completion Date: May 2010 Primary Completion Date: May 2010|
743733|NCT00972205||
743734|NCT00972153|Thirty-six patients of the surgeon who consented to undergo primary total hip arthroplasty between May and September 2009 were recruited to participate in this study. All consenting patients were eligible. Patients undergoing hemiarthroplasty, resurfacing, or revision arthroplasty were excluded from recruitment.|
743735|NCT00972088|from 2009 until june 2011 26 patients were enrolled from gastroenterology clinics|patients were enrolled to undergo capsule endoscopy of the small bowel if they had perianal disease and a negative colonoscopy with ileoscopy or a negative colonoscopy with a negative small bowel series or negative ct enterography
743736|NCT00972023|Cancer center clinic|
743737|NCT00971997||
743738|NCT00971932||
743739|NCT00971841|Original Study CA139-540 (NCT 00344552) at Dr. K. Kato National Cancer Center Hospital in Tokyo, Japan, closed in 2008 and one participant rolled over into Study CA139-557.|To be enrolled in Study CA139-557, participants with advanced or recurrent esophageal cancer must have completed original Study CA139-540 (NCT 00344552) and investigator(s) deemed that continuing treatment with paclitaxel would benefit the participant.
743740|NCT00971789||
743741|NCT00971750||
743742|NCT00971737||3 subjects were withdrawn prior to receiving intervention (2 due to development of new medical problems, 1 due to anxiety and non-compliance).
743743|NCT00971633||
743744|NCT00971620||
743745|NCT00971425||
743746|NCT00971321||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
743747|NCT00971295||
743748|NCT00971282||
743749|NCT00971243||
743750|NCT00971204||
743751|NCT00971178|Patients undergoing bilateral third molar surgery under general anesthesia in Queen Mary Hospital were recruited.|The patients were assessed by the scheduled anesthesiologist the day before surgery, were fasted for at least 6 hours and did not receive any premedication before arrival at the operation room.
743752|NCT00971048|Adults 18 years of age and older who had a DFU or PU on the foot that was a partial or full thickness wound|
743753|NCT00970944|February 23,2003 through March 15, 2010. Eleven rehabilitations centers in the USA (8) and Europe (3)|
743754|NCT00970853|Mothers from high poverty areas with singleton healthy infants weighing at least 2500g with no genetic or developmental disorders were recruited from post-partum unit of an academic hospital. At child age 8-years mothers were contacted for an in office follow-up visit. 187 of 253 eligible mothers participated.|
743755|NCT00970814|Interested candidates responded by telephone to advertisements at 5 academic centers in the United States between November 2009 and May 2010.|Must be alcohol dependent (DSM-IV criteria); and drinking very heavily (10 or more drinks/drinking day men; 8 or more drinks /drinking day women) 40% of the days during any consecutive 60-day interval during the 90-day period before the clinic screening visit, with at least 1 heavy drinking day occurring within the 14 days before randomization.
743756|NCT00970736||
743757|NCT00970684|Patients were recruited from local medical clinics from 12/2009 to 4/2011|
743758|NCT00970632||Period 1: Screening and 4-week washout of benign prostatic hyperplasia (BPH), overactive bladder (OAB), and/or erectile dysfunction (ED) treatments. Period 2: 4-week, single-blind, placebo lead-in to assess compliance and establish baseline levels. Period 3: Randomization to treatment (placebo, tadalafil 5 mg, or tamsulosin 0.4 mg for 12 weeks).
743759|NCT00970606|Study terminated due to lack of recruitment due to earlier than anticipated end to H1N1 flu season|
743760|NCT00970593||All participants received the background metformin immediate release tablets, during the 4 weeks run-in period. Compliant participants were then randomized to study treatments for a maximum period of 31 days.
743761|NCT00970502|All patients were evaluated by head and neck surgery, medical oncology, and radiation oncology before trial entry. Patients were enrolled at least 6 months after they had completed prior radiation. Patients were enrolled between March 2007 and December 2009.|
743762|NCT00970489|A total of 1,516 patients scheduled for cardiac surgery (CS) across 28 centers in the US, Italy, and Argentina, enrolled between Aug 2010 and Jun 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. 48% of screened patients and 94% of eligible patients were enrolled.|Ineligible patients were most often excluded because they were not in sinus rhythm (40.5%), were on fish oil (28.9%), or were unwilling to provide informed consent (23.5%).
743763|NCT00970359||
743764|NCT00970320|Primiparas during the period May 2009 and December 2010 and women sustaining obstetric anal sphincter injuries during the period 2009 to 2011 at Ostfold Hospital Trust and St. Olav's Hospital were invited to participate in the prevalence and intervention studies, respectively.|
743765|NCT00970307||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
743766|NCT00970294||
743767|NCT00970281||
743768|NCT00970268|Patient recruitment occurred from August of 2009 to March of 2010 and was by invitation only to patients who had completed study NCT00891462 (LAS-MD-33). In total, there were 77 individual study sites, 71 in the United States and 6 additional sites in Canada.|From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent To Treat (ITT) Population.
743769|NCT00970216||
743770|NCT00970203||
743771|NCT00970073||
743773|NCT00969761|An open-label, parallel group, 3+3 dose escalation trial Volasertib and cisplatin or carboplatin combination therapy was given on Day 1 of up to 6, 3-week cycles.|For the carboplatin arm, the target doses were calculated using the Calvert formula to achieve AUC 4, AUC 5 and AUC 6. Calvert formula: Dose (mg) = target AUC x (glomerular filtration rate (GFR) + 25); GFR = (140 - age [years]) x (actual weight [kg])/(72 x serum creatinine [mg/dL]). Multiply by another factor of 0.85 if female).
743774|NCT00969709|Patient recruitment at 38 study centers located in the United States during a 17 month period from September 2009 to February 2011.|The study included a 1-week, single-blind placebo run-in period immediately before the 8-week double-blind treatment period.
743775|NCT00969618||
743776|NCT00969553|A Phase I single dose escalation study of two dosing schedules of Volasertib administered intravenously in Asian patients with various solid cancers with repeated administration in patients with clinical benefit|Investigator notified the sponsor if a patient qualified for study participation. Sponsor informed the investigator about the respective treatment schedule and the dose tier. After completing dose level 1 of D1 schedule (i.e. 100mg), dose level 2 of D1 schedule (i.e. 200mg) and dose level 1 of D1+D8 schedule (50mg on Days 1+8,every 3 weeks) started
743777|NCT00969540|Recruitment was by advertisement.|A total of 8 participants were entered into this crossover study. The total duration of the study was approximately 49 days, including 14 days of screening and 14 days of the first intervention, 7 days of washout, and 14 days of the second intervention.
743778|NCT00969501||
743779|NCT00969436||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
743780|NCT00969332|Recruitment for this study began in May 2005. Patients were recruited from the inpatient and outpatient setting at the University of California, Los Angeles.|There was no wash-out or run-in period.
743781|NCT00969280|Recruitment period was from 15 September 2009 to 27 October 2009. Through the advertisements in regional newspapers or university websites, patients were recruited at the clinical research center of the Korea Institute of Oriental Medicine (KIOM) in Daejeon University hospital, Daejeon, Korea.|49 participants were tested for eligibility. 6 were excluded because of the insufficient pre-allocation test, denied informed consent and other reasons. After 1 week run-in period, 1 participant was excluded for withdrawal of informed consent. After all, 42 participants were included in this trial.
743782|NCT00969228||
743783|NCT00969150|Patient were recruited over a 12-month period from September of 2009 to September of 2010 at 24 studies sites in the United States.|Patients went through a 1-week single-blind placebo run-in period immediately preceding an 8-week double-blind treatment period.
743784|NCT00969124||
743785|NCT00968981||
743786|NCT00968968|A total of 37 subjects with HER2-positive metastatic breast cancer were enrolled.|Subjects enrolled in the study were randomized 1:1 to either of the arms.
743787|NCT00968890||
743788|NCT00968864|Candidates for bone marrow transplant who did not have a healthy HLA-identical related donor, at Levine Children's Hospital between December 2009 and June 2016.|Subjects were enrolled to two cohorts based on donor type, Mismatched Related Donor (MMRD) and Matched Unrelated Donor (MUD).
743789|NCT00968838|Recruitment Period: 07/16/2008 through 7/14/2011. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.|Of 178 participants registered, there were 108 participants included in the study and analysis. The 70 participants excluded were ineligible or unable to be matched with a transfusion donor.
743790|NCT00968812|This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) compared with glimepiride in participants with type 2 diabetes mellitus with inadequate glycemic control despite metformin treatment. The study was conducted between 28 August 2009 and 25 January 2013 and included 157 study centers in 19 countries worldwide.|1,452 participants were randomly allocated to the 3 treatment arms. 1450 participants received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented for Baseline to Week 104.
743791|NCT00968799|overall recruitment was poor. study was terminated after 6 patients (of 27 scheduled)|
743792|NCT00968708|Participants took part in the study at 898 investigative sites worldwide from 24 September 2009 to 18 June 2013.|Participants with a diagnosis of type 2 diabetes mellitus and acute coronary syndrome were enrolled equally in 1 of 2 treatment groups, once a day placebo or alogliptin, in addition to receiving standard of care for cardiovascular disease and diabetes.
743793|NCT00968669||A total of 329 participants was randomized into the study, but 2 participants (1 in the MEDI-528 30 mg arm and 1 in the MEDI-528 300 mg arm) were randomized by mistake as they were screen failures. Therefore, a total of 327 participants were correctly randomized into the study.
743794|NCT00968617||Participants in Cohorts 1 and 2 were to receive 1.0 mcg/kg/month and 2.0 mcg/kg/month, respectively, of MK2578. Participants in Cohort 3 were to be randomized to MK2578 3.6 mcg/kg/month or to weekly doses of darbepoetin alfa 0.45 mcg/kg/week. Cohort 1 was the only cohort initiated.
743795|NCT00968539||
743796|NCT00968526|At Day 21, all subjects had received 1 dose of GSK2340272A vaccine and therefore no distinction was made between groups for the Day 21 analysis.|
743797|NCT00968344|2009-2014: we recruited and studied middle-aged men and women (45-60 years), representative of the ethnic makeup of the United States. Volunteers were recreationally active but athletically untrained.After providing written informed consent, volunteers were screened in the UTMB Institute for Translational Sciences-Clinical Research Center.|
743798|NCT00968253|Recruitment Period: November 18, 2009 to March 21, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.|
743799|NCT00968227||
743800|NCT00968201|"Base Study: 93 sites in the United States (US) and other countries in Africa, Australia, Europe, North America, and South America. Therapy period: Dec-1997 to Mar-1999.
~Extension Study: 75 sites in the US and other countries in Africa, Australia, Europe, North America, and South America. Therapy period: Mar-1998 to Mar-2001."|"Base Study: Patients who required excluded medication and those who did not meet a minimum predefined level of asthma symptoms and β-agonist use during run-in (Period I) were excluded from randomization (Period II).
~Extension Study (Period III): Patients who did not complete Visit 9 of Base Study were not eligible for the optional Extension."
743986|NCT00958412||
749113|NCT00703261||
743801|NCT00968149|"Thirty one study sites in the United States.
~Prime Therapy Period: Mar-2001 to Jun-2001."|Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime rhinitis symptoms score during the run-in period were excluded from randomization.
743802|NCT00968071|Recruitment Period: 2/19/2008 through 5/12/2009. All participants recruited at UT MD Anderson Cancer Center.|
743803|NCT00968032|The recruitment period was set between June 2009 and July 2010 at a single medical clinic.|No enrolled participants were excluded from the trial.
743804|NCT00968019||
743805|NCT00967993||
743806|NCT00967941|recruitment was done during the period August 2007 through June 2009 at vascular center.|12 patients were excluded from study for being ineligible due to active infection, dialysis, allergy to penicillin,NO procedure, withdrew from surgery.
743807|NCT00967798|Participants were recruited between May 2010 and August 2016.|
743808|NCT00967694||
743809|NCT00967668||
743810|NCT00967616|A total of 100 participants who met all inclusion and no exclusion criteria were randomized to treatment in the study.|
743811|NCT00967551|Healthy, 06 to 48 months old children attending a day care. They were randomized into two groups and received daily zinc micronutrient + - test group (sprinkles) or without zinc micronutrient only - control. Children were supplemented for 90 days|
743812|NCT00967486||
743813|NCT00967473||
743814|NCT00967447|Only two patients were included into the study. The sponsor decided to finish it due to a delay of recruitment period.|
743815|NCT00967369|Recruitment Period: August 2009 to August 2011 at MD Anderson Cancer Center.|
743816|NCT00967330||
743817|NCT00967226||
743818|NCT00967044|Recruitment Period: November 25, 2009 to February 17, 2012. All recruitment was done at University of Texas (UT) MD Anderson Cancer Center.|Of the 31 participants recruited, one participant was excluded from the study as a screen failure.
743819|NCT00967018|The patients were recruited from 16 sites in Belgium, France, Italy, Spain, Sweden and Turkey. The study was conducted between 31 August 2009 (FPFV) and 29 November 2011 (LPLV).|
743820|NCT00967005||
743821|NCT00966992|The study opened to participant enrollment on 08/12/2009 and closed to participant enrollment on 08/31/2010.|
743822|NCT00966953|The dental clinic staff recruited for this study.|
743823|NCT00966940|Patients were recruited from four private practices located in Germany.|
743824|NCT00966875||Participants were randomized to Part A and had the option of continuing in the open-label extension, Part B after completing Part A.
743825|NCT00966849||The enrolment number (4043) represents the total number of Households enrolled in the study
743826|NCT00966823||1 participant met inclusion criteria and was enrolled, but was excluded immediately before intervention (active labor), and was therefore excluded from the trial.
743827|NCT00966719||
743828|NCT00966693||
743829|NCT00966654||
743830|NCT00966641||
743831|NCT00966550||
743832|NCT00966446||
743833|NCT00966433||
743834|NCT00966355|Patients with liver cirrhosis presenting with either hematemesis or melena between October 1, 2006 and May 31, 2010 at eleven medical centers distributed throughout Korea.|failure to fulfill inclusion criteria, no cirrhosis, prior endoscopic therapy within 2 weeks, enrolled within 6 weeks before index bleed, severe cardiovascular diseases, chronic renal failure, hepatocellular carcinoma invading portal vein, other malignancy, pregnancy, HIV-positive, hypersensitivity to the study drugs, or refusal to participate.
743835|NCT00966277|Recruitment period: April 06, 2010 to August 23, 2012. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.|Of the 87 participants enrolled on the study, only 75 were randomized. Twelve enrolling participants were screen failures or withdrew before randomization thus were excluded before assignments to groups.
743836|NCT00966264|Two hundred and thirty-six women referred for essential menorrhagia to five university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n= 119) or hysterectomy (n=117).|All randomised women were analysed as intention-to-treat
743837|NCT00966238|Participants were recruited across 3 clinical sites.|
743838|NCT00966186||
743839|NCT00965848||The total number of participants enrolled were 270, out of which 268 participants had adequate information for analysis.
743840|NCT00965757||
743841|NCT00965731||This study was planned to include 2 phases; phase 1 was a dose escalation safety and pharmacokinetic (PK) study followed by a randomized phase 2 efficacy and safety study. The study was discontinued and phase 2 not started; no participants were enrolled in that phase of the study.
743842|NCT00965718|"Patients with advanced pancreatic cancer who showed disease progression during gemcitabine-based chemotherapy were enrolled in this study.
~Twenty patients were enrolled between September 2009 and September 2010."|
743843|NCT00965575|recruitment was done from cincinnati children's neurology/epilepsy clinics during the period of June 2011 to Dec 2012.|Actual enrollment was 11. 10 completed the study
743844|NCT00965562|Recruitment occurred through on-site screening in private gynecological practices and community advertisements. Recruitment occurred between 2001-2005 in Providence, Rhode Island and between 2001-2009 in New Haven, Connecticut. Potential subjects provided consent for screening and assessment.|
743845|NCT00965523|Study 221 was conducted at 22 centers in Japan during the period of Jan 2008 to Sept 2009, and Study 224 was conducted at 5 centers in Japan from Aug 2009 to Jan 2011.|Study 224 was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221. Thus, combined data of Study 221 and Study 224 are reported.
743846|NCT00965497|Recruited through local neurology groups and ALS and MS support groups. No subjects with ALS were recruited.|Patients switched from another antidepressant to escitalopram were either cross-titrated to escitalopram over 1 week or went through 3 day washout before starting escitalopram. Subjects with uncontrolled medical conditions (i.e., uncontrolled hypertension)were excluded.
743847|NCT00965484||Participants who used the Genotropin® Pen for at least 3 months prior to enrollment were eligible to participate. Genotropin (somatropin) dose was not adjusted for the purposes of the study, but only based on clinical management requirements as determined by the treating physician.
743848|NCT00965458|Subjects were recruited during an approximate 84-week accrual period. Initially 66 subjects were planned; however, enrollment ended with 49 subjects as a result of the decision, unrelated to safety reasons, made by Astellas Pharma US, Inc. to discontinue manufacturing Amevive® (alefacept).|Subjects ages 12 to 35 years who were first diagnosed with type 1 diabetes mellitus (T1DM) within 100 days of enrollment. Subjects were randomly assigned in a 2 to 1 (2:1) ratio to either the alefacept or placebo group.
743849|NCT00965419||All enrolled participants that received edivoxetine during the open-label treatment phase for up to 5 years and follow-up phase.
743850|NCT00965341|Clinic outpatients with advanced cancer were recruited from September 2009 to November 2011 at both Michael E. DeBakey Veterans Affairs Medical Center (VA) and University of Texas MD Anderson Cancer Center (MDACC).|Of the 53 participants enrolled only 43 subjects met eligibility criteria. Ten participants either did not meet criteria or withdrew consent prior to assignment to groups.
743851|NCT00965263|Cocaine-dependent research volunteers who were explicitly not interested in treatment for their cocaine use signed a consent form approved by NYSPI IRB, which described the procedures and outlined the possible risks, including administration of an experimental vaccine and smoked cocaine.|
743852|NCT00965250||The thymic carcinoma cohort was closed after enrolment of 12 participants because of lack of activity.
743853|NCT00965237||
743854|NCT00965185|This study enrolled men and women with HIV disease, no history of cardiovascular disease or cardiac symptoms, and evidence of subclinical atherosclerosis at Massachusetts General Hospital in Boston, MA USA. The study was done from November, 2009 to January, 2014.|Of the 81 patients screened for the study, 40 completed the screening and were randomized to the two study arms.
743855|NCT00965146||215/229 subjects/cases enrolled and 5 subjects/cases censored=210/224 subjects/cases started
743856|NCT00965094||
743857|NCT00965081||Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
743858|NCT00965055||
743859|NCT00964886||
743860|NCT00964860||
743861|NCT00964795|After informed consent was obtained, the 323 participants who completed the parent study, VGFT-OD-0605 (NCT00509795), and met the protocol eligibility criteria, were enrolled at 71 clinical sites in the US & Canada. The first visit occurred concurrently with the last visit in the parent study. The last participant entered this study on 18-May-2011.|"Intravitreal Aflibercept Injection [commercially known EYLEA® (aflibercept) Injection] was approved in the US for treatment of neovascular (wet) age-related macular degeneration (AMD) as the study was ongoing. For collection of long-term safety and best corrected visual acuity data on EYLEA®, the study was extended in the US from 30 to 45 months."
743862|NCT00964782||One subject withdrew consent before being randomized and subsequent medication administered.
743863|NCT00964743||
743864|NCT00964678||
743865|NCT00964548|Recruitment dates: June 2007 - October 2008 Massachusetts General Hospital NeuroICU|Participants were excluded from study if transcranial doppler (TCDs) did not show elevated velocities suggesting vasospasm. See inclusion criteria regarding specifics. After enrollment, TCDs were repeated. Once the repeat TCD confirmed elevated velocities suggestive of vasospasm, a single dose of IV dantrolene was infused.
743866|NCT00964496|From November 2004 to November 2007, a total of 59 subjects were assessed for eligibility at Shanghai Ren Ji Hospital, China.|Among the 59 patients, two refused to enter the protocol and two other were excluded owing to severe associated disease with short life expectancy. Therefore, 55 patients were enrolled in our study.
743867|NCT00964444|Pregnant patients at term in early labor with a singleton vertex fetus and anticipated vaginal delivery are recruited in the labor & delivery suite of Harrisburg Hospital for this study|Due to the nature of the equipment, if a midwife or obstetrician was planning a bed delivery rather than using stirrups, the patient is excluded.
743868|NCT00964431||
743869|NCT00964392|The first subject was enrolled on September 29, 2009. Subject enrollment was completed and closed on October 01, 2013 after reaching a total of 437 enrolled (381 evaluable) subjects. The study is still ongoing. This report covers data up to the data download of June 23, 2015.|
743870|NCT00964366|Clinical research center. Subject recruitment occurred from July 16, 2009 to Aug. 11, 2009|Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.
743871|NCT00964353||Patients were deleted from the study due to patient delay of surgery, baseline INR being too high, patient rescheduling or canceling surgery, no INR ordered, no admission to hospital.
743872|NCT00964223|Clinical research centers|
743873|NCT00964158||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
743874|NCT00964119||
743875|NCT00964028||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
743876|NCT00963937||
743877|NCT00963924||54 patients were assessed for eligibility; however, 14 were excluded (11 were ineligible, and 3 withdrew consent). 40 participants were randomized, however 4 were excluded (1 serious adverse event, 2 withdrew consent, and 1 was lost to follow up), therefore 36 entered the treatment phase.
743878|NCT00963872|Subjects were recruited at the time of clinic visit or hospitalization. Patients that were considered for umbilical cord transplant were approached with the study.|Subjects that were eligible for umbilical cord transplant were considered for the study.
743879|NCT00963859|Recruitment Period: October 10, 2007 to December 07, 2009; All recruitment done in a medical clinic setting.|
743880|NCT00963820|Sixty (60) participants took part in the study at 6 investigative sites in the United States from 31 October 2009 to database lock on 28 February 2013.|Participants with a diagnosis of multiple myeloma (relapsed and/or refractory) were enrolled in the dose escalation phase to determine maximum tolerated dose (MTD). Once the MTD was established, participants were enrolled at the MTD into 1 of the 4 expansion cohorts.
743882|NCT00963677|Patients (ASA I-III) who required general anesthesia undergoing oral and maxillofacial surgery and agreed to participate in the present study were recruited from August 2009 to November 2009 in the Second Xiangya Hospital of Central South university. All the patients have signed the consented forms for the study.|55 patients were recruited into the study and assigned to two groups. The patients without predicted difficult intubation (n=35) were rectuited into Group A. The patients (n=20) with predicted intubation but not difficult ventilation were recruited into Group B. Two patients were excluded from the present study due to difficult ventilation.
743883|NCT00963638|Recruitment took place in a private practice clinic between April 15, 2009, and October 5, 2009. Potential study patients responded to a radio advertisement for the study.|Patients consented were asked to keep a daily diary for 1 week which documented frequency, duration, and severity of leg cramps. Blood was also drawn during this visit to assure values within range. At the second visit, patients who were within range for labs and meet the frequency/duration/severity of leg cramps were randomized.
743884|NCT00963599|"Forty study centers in the United States.
~Therapy Period: September 1999 to November 1999"|Patients who required excluded medication and those who did not meet a minimum predefined level of combined Daytime Nasal Symptoms score during the run-in period were excluded from randomization.
743885|NCT00963560|Bilateral diagnosis of cataracts of subjects >21 years of age.|During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
743886|NCT00963547|Per protocol, this trial was to be conducted in 2 parts. In Part 1 (Pt. 1), 33 participants were enrolled, with 31 participants receiving study treatment. Due to trial termination, enrollment into the study was discontinued and Part 2 (Pt. 2) did not begin.|
743887|NCT00963508||
743888|NCT00963482|01.07.2007-31.01.2010 Recruiting process 31.01.2010-31.07.2011 last follow-up sessions location of recruiting: alcohol detoxification unit follow-up: outpatient|Out of 237 screened patients, 103 were enrolled. Intervention group(EG)=53; Control group (CG)=50.
743889|NCT00963469|"Forty-seven study centers in the United States.
~Prime Therapy Period: August 2001 to November 2001"|Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime nasal symptoms score during the run-in period were excluded from randomization.
743890|NCT00963430|Participants were healthy pregnant women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09Sep2009 and 16Oct2009.|
743891|NCT00963235||
743892|NCT00963157|Participants were healthy adults age 18 and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 24Sep2009 and 16Nov2009.|
743893|NCT00963105|Participants were randomized at 29 sites from North America and Europe.|Participants were randomized (1:1:1) in a double-blind fashion, according to age (< 65 versus ≥ 65 years) and disease status (relapsed versus refractory) to their last purine-analog or bendamustine-based prior regimen.
743894|NCT00962949||
743895|NCT00962871|The study was conducted between 30 July 2009 to 01 February 2012 and recruited participants from 4 centers in New Zealand (1), Taiwan (1), and Singapore (2).|A total of 65 participants were screened of which 30 participants were randomized. 35 participants failed the screening evaluation mainly due to inability to meet the inclusion criteria and consent withdrawal.
743896|NCT00962780||
743897|NCT00962754|Patients were recruited upon admission to our neonatal high care ward from June 2009 to March 2010|
743898|NCT00962741||
743899|NCT00962650|Study Initiation Date: 09 June 2009 (First Informed consent signed) Study Completion Date:03 May 2010 (Last subject last visit) Enrollment Location: The Ohio State University Medical Center|All enrolled subjects provided informed consent to participate in the study, met protocol entry criteria, and had the study procedure attempted (ITT population).
743900|NCT00962598|Recruitment began in December 2005, with enrollment from January 2006 to June 2013. Participants recruited for this imaging from another study, GCO 12-1321.|
743901|NCT00962585|Patients for this trial were screened from 9 investigative sites in the United States and Australia. Participants were women of menopausal status and experiencing vasomotor symptoms and nocturnal sweating.|After completing screening visit assessments, subjects were instructed to refrain from taking prohibited medications throughout the study. Patients who were taking prohibited medications at the time of the screening visit discontinued their use and completed a suitable washout period before progressing to the next visit.
743902|NCT00962429||The Responsible Party has left the institution and has indicated that they do not have the raw data. They have confirmed that, despite all efforts to locate the data by contacting study team members, efforts were unsuccessful and no data are available.
743903|NCT00962390|Participants were recruited from 4 centers in Australia, 10 centers in India, and 8 centers in the United States from February 2010 to August 2015. The first participant was enrolled in August 2010, and the last participant was enrolled in August 2015.|
743904|NCT00962247|Families were recruited from the Buffalo NY area. 460 families were interested in screening for the study with 271 ineligible families, 4 families who were no longer interested and 28 families who withdrew from phone screen, for a total of 157 families eligible for an orientation appointment.|Prior to enrolling in the protocol, families completed an orientation, at which eligibility and interest were assessed. Families who enrolled, first completed three weeks of monitoring on the Television reduction device to determine eligibility (at least 18 hours/week of screen use) and compliance with physical activity accelerometer use.
743905|NCT00962208|Phone screening was conducted on all parents who responded to advertisements in local newspapers during March 2008 and June 2009. Those who passed the screening would be invited to attend the baseline visit at the Optometry Clinic of The Hong Kong Polytechnic University.|All subjects who passed the inclusion and exclusion criteria at the baseline visit would be assigend to the treatment according to the randomization log.
743906|NCT00962104||
743907|NCT00962091|Participants took part in the study at 3 investigative sites in the United States from 25 September 2009 to 01 July 2014.|Participants with a diagnosis of advanced solid tumors were enrolled to receive alisertib in 1 of 4 parts: Dose Escalation, Part A (relative bioavailability), Part B (food effect and multiple-dose pharmacokinetics of alisertib oral solution [OS]), and Part C (food effect and safety of alisertib enteric-coated tablets [ECT]).
743908|NCT00962078||
743910|NCT00962039|Subjects were clinically referred from primary care and specialty pediatric gastroenterology and were impaired as reflected by a score of less than 70 on the Children's Global Assessment Scale (CGAS).|Potential subjects with physical disease responsible for the abdominal pain, eating disorder, bipolar disorder, psychosis, alcohol/drug abuse, intellectual disability (IQ < 70), pregnancy, or prior trial of SSRI antidepressant or venlafaxine were excluded.
743911|NCT00962013||137/139 participants/hips enrolled and 17/17 participants/hips censored=120/122 participants/hips started
743912|NCT00962000||
743913|NCT00961961||"Phase I was an open label treatment, of Lithium and Fluoxetine, of all enrolled patients.
~Those who met criteria for response after 12 weeks were randomized to one of two Phase II (double-blinded) arms:
~Lithium plus Fluoxetine
~Lithium plus Placebo"
743914|NCT00961896||
743915|NCT00961805|The recruitment of patients started in August 2007 and finished in April 2008. The recruitment was made in Sao Paulo Hospital division of Rheumatology|
743916|NCT00961662|The study evaluated the data from 18 clinical study sites (11 sites in the United States and 7 sites in India)for approximately six months.|Clinical laboratory testing (including comprehensive hematology, clinical chemistry, liver function tests, lipid profile, HbA1c levels and urinalysis) was performed. A urine pregnancy test was performed for female subjects of childbearing potential.
743917|NCT00961649|Subjects were recruited from 9 investigational centers in the United States.|Of the 195 enrolled, 25 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (170).
743918|NCT00961636||
743919|NCT00961571|From 2007 to 2008, we treated patients with unresectable advanced colorectal cancer with Sunitnib 37.5 mg orally once daily and Capecitabine 1000 mg orally twice daily in a phase II clinical trial at Georgetown University Hospital|
743920|NCT00961532||
743921|NCT00961441|Intent-to-treat (ITT) population includes all enrolled patients who received at least one dose of study medication.Pharmacokinetic Per-Protocol (PK-PP) population is a subset of the ITT population, consisting of those patients who had no major protocol deviations affecting the pharmacokinetic parameters.|Participant Flow and Baseline characteristics refer to the Intention-to-treat (ITT) population.
743922|NCT00961415|A total of 414 participants were screened out of which 38 participants were excluded for not meeting the eligibility criteria, declining to participate, or for other reasons. A total of 376 participants were recruited over an 18-month period across 81 centers in 11 countries from 17 August 2009 to 3 May 2011.|Of the 376 participants enrolled in this study, 3 participants did not start induction phase treatment.
743923|NCT00961402|Recruitment occurred from January, 2010 through May, 2011 and follow-up assessments were completed by November, 2011. Participants were recruited via advertisements to the general public.|The major reason for why participants who consented but did not participate was that they failed to return our telephone calls after they had their baby or we were unable to obtain physician consent for them to participate.
743924|NCT00961350||
743925|NCT00961311||
743926|NCT00961298|Subjects were referred by a gastroenterologist who had Irritable Bowel Syndrome and anxiety.|Two participants were considered screen failures and were not entered into the placebo run in phase.
743927|NCT00961259|Fifty-Four (54) non-obese, non-smoking, healthy adult volunteers from the community at large were enrolled.|One hundred and eight (108) subjects were screened. Thirty-six (36) subjects were screen failures. Of the remaining seventy-two (72) subjects, fifty-six (56) checked in and fifty-four (54) were enrolled.
743928|NCT00961233||
743929|NCT00961220|Patients were recruited from February 2010 to November 2013 from University Hospital Case Medical Center.|
743930|NCT00961181|From 14 August 2009 to 26 April 2010 a total of 81 patients at 9 heart centres in Europe were enrolled. Last follow-up was completed 09 May 2011.|No group assignment.
743931|NCT00961116|Fifty-four (54) non-obese, non-smoking, healthy adult volunteers, consisting of members of the community-at-large, were enrolled.|
743932|NCT00961064||
743933|NCT00961051|Subjects for this study were chosen from the normal hydrogel contact lens-wearing patient populations at each of the investigational sites according to the following inclusion and exclusion criteria.|
743934|NCT00960999||
743935|NCT00960986||Period 1 was a 3- to 30-day screening and washout period; Period 2 (Week 0-1) was a 1-week initial dosing period (randomization to duloxetine 30 mg with food, 30 mg without food, 60 mg with food, or 60 mg without food); Period 3 (Week 1-8) was a 7-week therapy period (treatment switched to duloxetine 60 mg once daily (QD) until study end.
743936|NCT00960934||383 participants were randomized on study and 380 participants were treated on study.
743937|NCT00960869|A multi-center US study in which 75 sites recruited subjects between October 2009 and July 2011|Screening for eligibility and wash-out of restricted medications
743938|NCT00960856|Non-obese, non-smoking, healthy adult volunteers consisting of members of the community-at-large were enrolled.|88 subjects were screened and 51 were screen failures. Enrollment of 40 subjects was planned, however, the enrollment of 37 subjects was judged to be sufficient to meet the criterion of 36 necessary to complete the study.
743939|NCT00960843||
743940|NCT00960778||
743941|NCT00960687|Fifty-Four (54) non-obese, non-smoking, healthy adult volunteers, consisting of members of the community-at-large, were enrolled.|Ninety-nine (99) subjects were screened. Forty-five (45) subjects were screen failures. The remaining fifty-four subjects were enrolled, 47 of whom completed the study.
743942|NCT00960661||1036 patients entered the study, 637 were assigned to the two interventional study groups. 10 patients assigned to treatment groups did not receive study drug.
743943|NCT00960622|Subjects were recruited from clinics.|Subjects had to take combivir or trizivir for at least 6 months prior to enrollment
743944|NCT00960570|Thirty (30) healthy, non-smoking adult male and female volunteers from the community at-large were enrolled.|Forty-nine (49) subjects were screened. Nineteen (19) were screen failures.
743945|NCT00960531|Planned duration was approximately 2 years (including 18 months of treatment + 6 months of follow-up). Participants who completed lead-in B2571005 study through Week 78 had the option to stay in the lead-in study, or to roll-over into the extension protocol B2571008.|
743946|NCT00960505||
743947|NCT00960440||
743948|NCT00960375|Participants attended outpatient mental health programs at the Baltimore, Perry Point, and Washington DC VA Medical Centers. Participants had DSM-IV diagnoses of schizophrenia spectrum disorders, affective psychosis, other psychotic disorder, major depression with psychotic features, or post-traumatic stress disorder.|To ensure functional impairment in line with SMI, participants with PTSD had to have worked less than 25% of the past year or receive disability payment for PTSD.
743949|NCT00960323|Forty-two volunteers were screened for participation in this study. Eight were screen failures, four were not needed, four withdrew consent and two had a schedule conflict.|
743950|NCT00960297||
743951|NCT00960206||There were 413/464 participants/hips enrolled. Started, completed and not completed counts are reported by hip.
743952|NCT00960193||
743953|NCT00960154||
743954|NCT00960141|"Twenty-nine study centers in the United States.
~Therapy Period: August 2000 to October 2000"|Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime nasal symptoms score during the run-in period were excluded from randomization.
743955|NCT00960115|First/last subject (informed consent, Step 2 [randomized part]): 03 Feb 2010/15 Feb 2012. Clinical data cut-off: 01 May 2014. Study completion date: 15 June 2015|Enrolled: 197 screened for eligibility; 25 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria) and 172 subjects randomized.
743956|NCT00960076||Of the 393 subjects who entered the lead-in period, 111 subjects did not enter the randomized, double-blind treatment period. Thus, a total of 282 subjects were randomized and treated.
743957|NCT00960063||
743958|NCT00960011||
743959|NCT00959985||
743960|NCT00959946||Study was pre-maturely terminated after part 1 (safety lead-in phase) of study and hence, planned treatments of part 2, Bosutinib 300 milligram (mg) + Capecitabine 1000 mg/square meter (mg/m^2) (Part 2): estrogen receptor positive (ER+) and Bosutinib 300 mg+Capecitabine 1000 mg/m^2 (Part 2): estrogen receptor negative (ER-), were not administered.
743961|NCT00959920|Participants were enrolled 7/09-11/09 from the obstetric units of the Loyola University Health System hospitals. Subjects included adult women with a singleton pregnancy who presented to the Labor & Deliver in active labor or for induction, were anticipated to have an normal spontaneous vaginal delivery (NSVD), and had an epidural.|Every patient was assigned to a group immediately following enrollment.
743962|NCT00959907|"Recruitment process: It is planned to recruit a total of 58 subjects at one single centre, Brazilian Center For Studies in Dermatology, in Porto Alegre, Brazil. The anticipated drop out rate is 10%.
~Baseline evaluation: May 2005 to July 2007."|13 volunteers were excluded; (screen failure) Iodine allergy=2 Minor´s Test failure=6 Mild wrinkles=3 Inclusion criteria failure=2
743963|NCT00959894||80 participants were enrolled, however 1 participant was found to be ineligible on the day of entry and never started study medication (had developed acute renal failure and therefore no longer met eligibility requirements).
743964|NCT00959764|Patients were recruited from clinics in the USA,UK,Poland, Bulgaria, Hungary, and Republic of South Africa.|Unequal randomization was used for the study, with patients being assigned after inclusion/exclusion criteria were met.
743965|NCT00959751|Study Period - 6 months. First subject screened 28 July 2009, Last subject completed the study 9 February 2010.|
743966|NCT00959699||One participant in the pegylated interferon alfa-2b (PegIFN-2b) + ribavirin (RBV) + boceprevir group withdrew from the study after randomization but prior to administration of any study treatment.
743967|NCT00959660||
743968|NCT00959647||
743969|NCT00959374|First subject was consented 12Aug2009 and last subject final follow up visit 15May2011. 241 subjects were enrolled from 9 sites in the USA and Europe. Of those, 229 were consented, randomized and treated. All subjects were volunteers scheduled for individual or combined abdominoplasty, mastopexy or reduction mammaplasty.|
743970|NCT00959192||
743971|NCT00959166||
743972|NCT00959049|Participants were enrolled into this study during the autumn of 2009 at 23 sites in the US.|A total of 1474 participants were enrolled, vaccinated and analyzed.
743973|NCT00958919|March 2009 - June 2010; medical center|17 subjects recruited; 3 subjects excluded (2 did not meet inclusion criteria; 1 refused participation after signing consent).
743974|NCT00958893||
743975|NCT00958880|Participants were screened for eligibility criteria using an online screen. Potentially eligible participants were invited to the laboratory for a psychiatric interview. Eligible participants were enrolled in the Dallas area from 2009 to 2012.|Participants were not enrolled if they did not meet the study inclusion criteria at a psychiatric screening or medical evaluation designed to rule out contraindicated psychiatric or medical conditions.
743976|NCT00958841|For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.|
743977|NCT00958828||
743978|NCT00958789||226 participants/228 knees were enrolled in the study. 47 participants/47 knees were censored from the main cohort. One bilateral participant had one knee censored and one knee included in study so this participant counts in the total. Therefore, 180 participants/181 knees are followed and applicable data is reflected in this record.
743979|NCT00958776||
743980|NCT00958724||
743981|NCT00958711||
743982|NCT00958581|Consenting completed at PI and co-investigators' private offices, clinic and in preoperative center. Study staff approved by the IRB consent the patients. First patient enrolled on 12/16/2008. Last patient enrolled on 9/17/2012.|Patients were excluded from the trial after enrollment if their surgery was cancelled.
743983|NCT00958568||The study consisted of 4 treatment phases: a screening phase (Study Period I [SPI]) of 3 to 14 days; a 6- to 8-week (wk) acute open-label treatment phase (SPII); a 12-week open-label stabilization treatment phase (SPIII); and a 27-week double-blind (DB) randomized relapse prevention treatment phase (SPIV).
743984|NCT00958477|First/last subject (informed consent): 14 Oct 2008/21 May 2010. Last subject completed: 03 March 2011.|
743985|NCT00958438|The study was conducted at 57 study sites in European Union (EU) and rest of world (ROW) between 7 March 2009 and 17 December 2010. A total of 471 participants were screened in the study.|Out of 471 participants, 248 were randomized and treated in the study. Participants were randomized in 1:1:1 ratio to receive Placebo or Rilonacept 80 mg or Rilonacept 160 mg.
743989|NCT00958334||ZPU-003 EXT was an open-label extension study of ZPU-003 (NCT00882258) and all patients received active medication (25 mg of Proellex); results were summarized according to the following groups - subjects who previously received active drug, by dose (12.5 mg and 25 mg) and subjects who previously received placebo in the double-blind ZPU-003 study.
743990|NCT00958308|1120 patients screened, 255 enrolled at the Xinhua/Yuyao Hospital, Shangai Jiao Tong University, China between Oct. 2008 and March 2009.|Inclusion & exclusion criterias were used to randomized patients.
743991|NCT00958282||
743992|NCT00958256|Recruitment Period: August 5, 2009 to March 28, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 22 participants enrolled, one participant was excluded from the trial before treatment.
743993|NCT00958243||
743994|NCT00958217|Veterans referred to a VA dual diagnosis outpatient clinic who were diagnosed with depressive disorder, substance use disorder, and had a history of trauma (with and without a posttraumatic stress disorder diagnosis) were recruited from December 2009 through October 2012.|All participants engaged in 12 weeks of group Integrated Cognitive Behavioral Therapy and were then randomized to the individual study interventions. 31 participants were not randomized (3 died, 6 moved, 6 withdrew, 4 lost, 4 not stable, 4 did not meet study criteria, 4 sober living facility did not allow).
743995|NCT00958191|For bilateral hip replacement participants, if one hip completed primary endpoint #1 the participant is counted as completed. If one hip was censored, but the other hip was not, the hip is counted as censored, but the participant is not.|250 participants/271 hips enrolled - 29 participants/31 hips censored= 221 participants/240 hips followed. There were 5 revisions, but one bilateral participant had one hip revised and the other hip completed the primary endpoint. This participant is counted as completed and not in the revision category.
743996|NCT00958165||
743997|NCT00958126||
743998|NCT00958074||
743999|NCT00958035||
744000|NCT00958009|109 subjects were recruited from 12 US clinics in the US during the trial period Oct 2009 to April 2010.|Subjects who signed informed consent and satisfied the eligibility critera at screening returned to the clinic on study day 1 to begin treatment. All subjects participating in the trial received Rebif 44 mcg subcutaneious (sc, three times per week (tiw) using the single-use autoinjector (SA).
744001|NCT00957996||
744002|NCT00957944|A total of 40 healthy, male subjects has been randomized in order to complete the trial with at least 30 subjects eligible for the Pharmacokinetic Set (PKS). Baseline characteristics refer to the PKS.|One subject that fulfilled predefined criteria for patch adhesiveness was excluded from the PKS.
744003|NCT00957931||
744004|NCT00957905||
744005|NCT00957853||A total of 16 patients were enrolled in the study; however only 15 patients were started on the trial since 1 subject withdrew consent for the study.
744006|NCT00957827||low enrollment and data not analyzed, patient lost to follow-up.
744007|NCT00957801||46 subjects screened, 15 subjects did not qualify, 2 subjects did not choose to participate. 29 subjects began the study and 28 subjects completed the study.
744008|NCT00957723||467/500 participants/knees enrolled;56 participants/60 knees censored = 411/440 participants/knees followed
744009|NCT00957684|Study initiation date: 15/July/2004(first visit of the first patient) Study Part I completion date: 09/November/2005(last Part I visit of the last patient) Study Part II initiation date: 11 JAN 2005 (first Part II visit of the first patient) Study Part II completion date: 04 JAN 2007 (last Part II visit of the last patient)|"After completing the baseline period, patients were randomised in a 1:1:1:1 ratio to 1 of the 3 Eslicarbazepine acetate (ESL) dose levels or to placebo.
~Part II was a 1-year open-label extension for patients who had completed Part I"
744010|NCT00957671|Subjects with a history of mild to severe traumatic brain injury were recruited from 2010 to 2014. Subjects were screened for abnormal growth hormone secretion by glucagon stimulation test. 19 subjects were screened for this study. 15 of the subjects met final inclusion/exclusion criteria and began the treatment phase.|
744011|NCT00957658||241 participants/249 hips - 7 censored participants/7 hips = 234 participants/242 hips
744012|NCT00957593|ROUTINE oxytocin 127 Discontinuation of oxytocin 125|
744013|NCT00957580|First/last subject (informed consent): September 2009/12 April 2012. Last subject completed : December 2012; Clinical data cut-off: December 2012.|Enrolled: 116 screened for eligibility; 35 were excluded (mainly non-fulfillment of inclusion or exclusion). 81 subjects were randomized.
744014|NCT00957528|Subject recruitment began in January, 2006 and was closed on December, 2011. Subjects were enrolled at the University of Texas Medical Branch in the Institute for Translational Sciences Clinical Research Center (ITS-CRC).|Screening was conducted at the ITS-CRC where the subject was consented and screening was conducted to identify eligible subjects.Screening included blood testing and a stress test to determine fitness for physical function testing. Subjects were excluded due to elevated PSA levels, testosterone levels above entry criteria or occult disease.
744015|NCT00957424||
744016|NCT00957372|"Patients were screened at 39 sites in 3 countries.
~STUDY DATES:
~PART I: from: 14 Dec 2004 to: 19 Jan 2007 PART II: from 21 June 2005 to 22 January 2008"|The duration of Part I was 26 weeks, including the 8-week baseline period. After completing the baseline period, patients were randomized in a 1:1:1 ratio to 1 of the 2 ESL daily dose levels (1200 or 800 mg) or placebo.Part II was a 1-year open-label extension for patients who had completed Part I
744017|NCT00957359||
744018|NCT00957333||
744019|NCT00957268|Participants took part in the study at 6 investigative sites in the United States from 17 Sep 2009 to 22 Nov 2013.|Participants aged 10 to 65 with a diagnosis of type 2 diabetes mellitus were enrolled in 1 of 5 treatment groups and received 12.5 or 25 mg alogliptin once.
744020|NCT00957242|Subjects were randomized at 25 U.S. sites in a 1:1 ratio to warfarin or matching placebo for a planned treatment period of 48 weeks. International normalized ratios (INR) were monitored using encrypted home point-of-care devices that allowed blinding of study therapy.|
744053|NCT00955357|An estimated 656 subjects were to be enrolled in the study at approximately 130 sites in the US, Europe, and the rest of the world.|Overall 461 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 456 subjects were included in the Safety Set.
744021|NCT00957047|"STUDY DATES:
~PART I - From: 01 Sep 2004 To: 19 Dec 2006; PART II - From: 02 February 2005 To: 29 January 2008 Patients were screened at 46 sites in 13 countries for Part I and Patients from 42 sites in 12 countries continued in part II.;"|Part I was a 22-week parallel-group, randomized, placebo controlled period. After completing the baseline period, patients were randomized in a 1:1:1:1 ratio to 1 of the 3 ESL dose levels or to placebo. For Part I 400 patients were planned; of 503 patients screened, 395 were randomized. 325 patients who completed Part I were enrolled in Part II.
744022|NCT00957034|6 month trial, screening started 22 Sep 2009 and ended 24 Mar 2010.|
744023|NCT00957021||409 participants/500 knees enrolled - 55 participants/65 knees censored = 354 participants/435 knees followed.
744024|NCT00957008|We conducted a total of 787 telephone screening interviews between February 2008 and February 2009 from the greater Columbia, South Carolina area. 197 men and women were eligible. Participants were recruited using a wide variety of techniques, including newspaper, mailers, community events, and worksite and other e-mail distributions.|Exclusion criteria included significant weight loss (>20 lbs) in the last 6 months, elevated blood pressure (160/95 mm Hg), ailments that limited their physical activity, or serious medical conditions or other issues (e.g. pregnancy or depression) contraindicating or confounding the weight loss intervention.
744025|NCT00956943|Media ads asked treatment-seeking smokers to call for information about a smoking cessation program and to have their initial eligibility reviewed. Participants interested in the clinical trial and initially eligible attended an in-person session to determine their final eligibility. Recruitment was from 2009-2011.|To be eligible, participants had to be: between age 18 and 55, smoke >10 cigarettes/day, and able to communicate in English. In addition, participants had to have a 3-HC/cotinine ratio that placed them in the top 3 quartiles of the 3-HC/cotinine ratio distribution to be consider fast nicotine metabolizers, which was >.18.
744026|NCT00956930|All BCLC stage HCC patients were reviewed by the multidisciplinary tumor board(transplant surgery, hepatology, medical oncology, and interventional radiology) between October 2009 and October 2015.|179 patients BCLC A/B patients were eligible. 43 declined to participate, 29 selected other clinical trials, 49 requested Y90 and 13 requested cTACE. 45 agreed to be randomized.
744027|NCT00956839|Patients were recruited from Endocrinology and Gastroenterology Clinics of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow from July 2009 to December 2009|All patients who consented for the study were enrolled and randomized.
744028|NCT00956813||One-hundred-five patients were randomized to each of the Flaxseed arm and the Placebo arm. After unblinding, all patients had the option of continuing Flaxseed treatment for 6 additional weeks to obtain longer term information about the effects of flaxseed for the management of hot flashes and to allow the placebo arm to try the flaxseed.
744029|NCT00956761|Overall, 63 participants ≥65 years of age were enrolled at 2 sites in Italy.|Blood samples for the determination of antibody titers were drawn on Day 0 prior to vaccination.
744030|NCT00956709||
744031|NCT00956657|Recruitment began in November 2008 and was completed in May 2009. All recruitment took place in out-patient cardiac rehabilitation departments within hospital buildings.|
744032|NCT00956631|Patient enrollment July 2008 to January 2010 at fourteen study sites. Treatments were performed in an outpatient setting at an hospital outpatient or ambulatory surgery center.|After enrollment and prior to surgery patient was excluded if patient had procedure or trauma at study treatment level, used acetylsalicylic acid (ASA) or non-steroidal anti-inflammatory drug (NSAID) within five days of treatment, epidural steroid injection (ESI) within 3 weeks of treatment.
744033|NCT00956592|Patients were recruited at OHSU OR and procedure rooms. 300 patients were enrolled in the study from 10/09-12/10|4 exclusions were noted for failure to follow the randomization
744034|NCT00956540||
744035|NCT00956293|The study consisted of a main period and a 54 month observation follow-up period. The main period included a pre-randomized treatment phase (6 weeks) and a randomized treatment phase (18 weeks). All randomized participants, who participated in the main period, were eligible for the follow-up period.|At baseline (BL) 1 (pre-randomization), eligible participants received a CNI-based regimen for 6 weeks. At BL2 (randomization), eligible participants were randomized in a 1:2 ratio to the control group or everolimus group.
744036|NCT00956254||
744037|NCT00956085||
744038|NCT00956020||
744039|NCT00955968|There were 1653 participants randomized to the study with enrollments from the US, Argentina, Botswana, Brazil, China, Haiti, and Thailand. The first participant was randomized on January 2010. The last participant was randomized in November 2014.|There were 1917 participants screened for the study, 264 of these failed screening and were not enrolled. The most common reasons for screening failure were CD4 cell count out of range, did not return for consent, test results unavailable on protocol specified time frame, not willing to participate, and not willing to remain on antiretrovirals.
744040|NCT00955955||
744041|NCT00955916|Between August 2009 and April 2011, participants were enrolled at Moffitt Cancer Center.|
744042|NCT00955903||3 participants were subsequently diagnosed with cancer after enrollment and thus disqualified from continuing in the trial. They were dropped from the analysis.
744043|NCT00955877||
744044|NCT00955825|First Patient First Visit 22 OCT 2008, Last Patient Last Visit 13 AUG 2009|
744045|NCT00955747|Patients were recruited in site physicians' offices.|Patients participated in an eight week run-in period during which diabetes education was provided and diet and exercise were stabilized.
744046|NCT00955721||
744047|NCT00955708||
744048|NCT00955682|Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.|During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
744049|NCT00955617||
744050|NCT00955513|6 centers in Germany. Recruitment commenced in July 2009 and completed in December 2009.|
744051|NCT00955487||
744052|NCT00955474|Participants were recruitment through newspaper advertisements in the Boston metro area.|Participants were required to wash-out prior to randomization and study procedures. If the patient was unable to wash-out (by personal choice or doctor's recommendation), they were excluded. Seven subjects withdrew consent prior to randomization.
744054|NCT00955305|This study opened to accrual on March 9, 2010 and was suspended on February 24, 2011 for safety evaluation. As the safety criterion was met, this study reopened on May 16, 2011 and closed to accrual on June 28, 2013 due to the end of the clinical development program with cixutumumab (IMC-A12) with final accrual of 175 patients.|
744055|NCT00955279||
744056|NCT00955266||
744057|NCT00955253||
744058|NCT00955201|Edward Hines Jr. VA Hospital from January 2010-May 2014.|Prior to group randomization, all consenting subjects underwent two separate symptom-limited treadmill stress tests to unmask potentially life-threatening indolent cardiac and/or respiratory disease limitations
744059|NCT00955110|The period of recruitment was from 29 May 2009 (first subject enrolled) to 01 September 2009 (last subject completed).|A double-blind crossover qualification phase (hydromorphone 8 mg vs. placebo) was followed by a washout period and then randomization to a 5-period, 10-sequence crossover treatment phase. Approximately 40 qualified subjects were to be enrolled in the treatment phase in order to ensure that at least 30 subjects completed all 5 periods of the study.
744060|NCT00955032|Patients seen clinically for routine clinical care were determined by clinicians if they appeared to qualify for the study. Subjects were asked and consented in a non-coercive manner if they wished to be contacted via telephone about future study participation. Recruitment occurred between March 2007-December 2009.|
744061|NCT00954993||
744062|NCT00954941|Recruitment Period: 11/11/09 to 3/20/2013. All participants registered at The University of Texas M.D. Anderson Cancer Center.|Of the 100 participants registered for screening on this study, fifty participants were randomized to Ondansetron alone (Group 1) and forty-eight participants to Ondansetron plus Aprepitant (Group 2).
744063|NCT00954915|Recruitment began at two academic institutions in April 2010 and was halted on December 17, 2010 after the first subject had an injection site reaction that met study stopping criteria.|
744064|NCT00954824|Non-tobacco using individuals between ages 18-40 in 2 groups- with metabolic syndrome (having 3 of 5 criteria) and non-metabolic syndrome.|
744065|NCT00954733|Subjects were approached in the pre operative area sequentially.|
744066|NCT00954707|A total of 2509 patients were enrolled from August 28, 2009 to January 14, 2011 across 139 clinical sites in the Unites States.|During the Phase I of this study, enrolled subjects were treated with at least one CYPHER® stent plus thienopyridine treatment and aspirin. During Phase II, approximately 1500 eligible subjects were randomized to either placebo or thienopyridine treatment. It is estimated that the Phase II results will be available for publishing by July 31, 2014.
744067|NCT00954681||
744068|NCT00954538||
744069|NCT00954512||
744070|NCT00954447||Randomised, double-blind, placebo-controlled, parallel group study. Whilst 1263 were randomised, only 1261 were treated.
744071|NCT00954421||
744072|NCT00954356|All 61 subjects were recruited at a single center between September 29th and November 16th 2009.|
744073|NCT00954187||
744074|NCT00954174|A total of 637 subjects were enrolled between 08/17/2009 and 3/24/14. Enrollment initially included uterine carcinosarcoma and was expanded to ovarian carcinosarcoma in June 2010 and then to include fallopian tube and peritoneal carcinosarcoma in October 2013. The primary analysis was restricted to patients with uterine carcinosarcoma.|
744075|NCT00954122|18 Years to 65 Years Male & Female Acte schizophrenia (DSM-IV) Positive and Negative Syndrome Scale (PANSS) score at least 75, Clinical Global Impression (CGI)|40 patients enrolled, 35 patients randomised and 28 patients completed the study
744076|NCT00954109||
744077|NCT00953927||
744078|NCT00953862|Study participants were adult Odyssey House residents who met DSM-IV criteria for ADHD based on the Adult ADHD Clinician Diagnostic Scale v1.2 (ACDS v1.2) and drug and/or alcohol dependence based on Structured Clinical Interview for DSM Disorders - Patient Edition (SCID-I/P). Study was conducted from July 2005 to February 2007.|Patients were excluded if they had a diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder, as assessed by clinical history and the SCID-I/P; seizure history (other than febrile seizures); current chronic or acute illness or medical condition, glaucoma, organic brain disease, traumatic brain injury, pregnancy, or lactation.
744079|NCT00953849||
744080|NCT00953745||
744081|NCT00953719|"Patients were selected for recruitment into the study from the general diagnosis population defined as primary total hip arthroplasty (THA) for non-inflammatory degenerative joint disease (NIDJD). The investigation was conducted at 5 centers. The same inclusion and exclusion criteria applied to both investigational and control groups."|1 subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the Adverse Event data reported, but the subject was not included in the the number of participants because there are no follow-up data on this subject outside of operative details.
744082|NCT00953706||
744083|NCT00953680||
744084|NCT00953667|400 subjects were enrolled over an approximate 3.5 year period in order to reach target of about 300 subjects completing all visits. Study ended with 277 subjects completing all visits.|All subjects received niacin and LPS doses. There were no separate arms.
744085|NCT00953654|Women were recruited from from a University and Community setting from August 2009 to March 2010. 1044 women were screened using online screening questionnaires; 853 were excluded for having too few worry symptoms or too high a physical activity level. 55 completed diagnostic interviews - 25 were excluded for no Generalized Anxiety Disorder.|Thirty women met exclusion criteria and were enrolled in the trial.
744086|NCT00953615|Participants were recruited between 4/6/2006 and 5/7/2009 at Mayo Clinic outpatient area.|
744087|NCT00953576|Participants enrolled from September 2009 until December 2011.|
744088|NCT00953524|Participants were enrolled from 06 August 2009 to 07 August 2009 at 15 US clinical centers.|A total of 849 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
744089|NCT00953407||Two participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
744090|NCT00953329|Recruitment ended in Dec 2008. Clinical Trial was located in Medical Center Clinic.|No adverse events occurred
744091|NCT00953290|The study subjects were recruited in the medical clinic 01/30/09 through 04/07/09.|
744092|NCT00953225|Recruitment was based in the Urology Clinics at the Medical University of South Carolina (MUSC) and the Charleston VA Medical Center, and the MUSC Radiation Oncology Clinic, all located in Charleston, SC. The recruitment period was from October 2010 through December 2012.|
744093|NCT00953212||
744094|NCT00953199|March 2010 -May 2013, recruited from the endoscopy unit|
744095|NCT00953173||
744096|NCT00953160|The study subjects were recruited in the medical clinic 01/01/09 through 01/13/10.|
744097|NCT00953147||
744098|NCT00953121||
744099|NCT00953056|A total of 144 participants were enrolled; 48 in each of 3 cohorts. This study was conducted sequentially in the 3 different Cohorts, Chinese adults (Cohort I) first, followed by children (Cohort II), and then infants (Cohort III).|
744100|NCT00953043|The study was conducted between September 2007 and July 2008 at the Mayo Clinic, Rochester, Minnesota.|
744101|NCT00953017|All pateints were recruited and enrolled at Brooke Army Medical Center in San Antonio, TX from July 1, 2009 to July 1, 2010.|NO significant events occured prior to study participant enrollment.
744102|NCT00952848|Dates of recruitment: 06/12/2009 - 10/26/2009 Location of recruitment: medical clinic|
744103|NCT00952822|Enrollment was conducted in the United States at 11 sites. Two cohorts were recruited (adolescent/adults aged ≥12 to ≤65 years and pediatrics aged ≥2 to <12 years).|Subjects meeting inclusion criteria were randomly assigned to receive a single sequence of 2 pharmacokinetic (PK) infusions of rAHF-PFM: reconstituted in 2mL then 5mL sterile water for injection (SWFI) or vice versa. Before each PK evaluation ≥3 day washout and negative factor VIII inhibitor titer was required. Ten subjects were screen failures
744104|NCT00952731|Between November 2009 and July 2011, subjects were recruited at Northwestern University and Washington University. The original accrual goal was 112, however, the study was halted early due to drug supply issues.|A total of 31 subjects were registered to the study but only 27 were randomized and began the study. Three participants were deemed ineligible and 1 withdrew consent before randomization.
744105|NCT00952718||
744106|NCT00952705|Participants were screened for the study within 30 days prior to randomization at investigator clinic sites in the USA. The first and last dates of informed consent were 14Aug2009 and 26Aug2009, respectively.|Of 1,888 participants who provided written informed consent and were screened for the study, 88 were screened but were not randomized into the study due to one or more of the following reasons: not meeting the eligibility criteria; study was full; withdrawal of consent; lost to follow-up; unable to obtain a blood sample for immunogenicity testing.
744107|NCT00952653||
744108|NCT00952614||Twenty nine (29) participants were consented, 30 eyes. Of the 29 consented, there were 23 subjects included in the data pool of which one subject had both eyes included in the study.
744109|NCT00952588|First patient was randomized on 22/07/2009 and last patient last visit has occurred on 27/06/2011.|
744110|NCT00952523||
744111|NCT00952484|Patients were recruited to participate in the study from September to December 2009 at investigational sites via posting in clinicaltrials.gov and contact with physicians experienced in the diagnosis and management of HPP. De-identified historical controls were also selected from a natural history database of patients with HPP.|Patients meeting eligibility criteria were randomly assigned to receive 2mg/kg or 3mg/kg of asfotase alfa SC 3 times weekly for 24 weeks.
744112|NCT00952419|Participants were enrolled from 06 August 2009 to 13 August 2009 at 19 US clinical centers.|A total of 474 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
744113|NCT00952393||
744114|NCT00952380||The study was conducted in the 5 countries from 20 August 2009 to 20 March 2018. A total of 38 participants were enrolled. This study had dose adjustment (DA) phase (Day 1-7), pharmacodynamic (PD) phase (Day 8-14) and follow up (FU) phase (Day 15-104).
744115|NCT00952367||In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population.
744116|NCT00952341||
744117|NCT00952315||
744118|NCT00952289||
744119|NCT00952276|Participants were enrolled from 29 October 2009 to 13 November 2009 at 14 US clinical centers.|A total of 548 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
744120|NCT00952211|The study opened for enrollment on 9/16/09 at San Diego Rehabilitation Institute. Enrollment was halted in April 2011 and the study terminated due to low recruitment numbers.|
744121|NCT00952133|Recruitment from July 2010 until December 2011 in pre-surgical clinic and in same day surgery.|
744122|NCT00952120||104 unique patients were enrolled with a total of 157 wounds (80 of the wounds received GSUC and 77 of the wounds received vacuum-assisted closure).
744123|NCT00952081|Patients scheduled for intracranial surgery were prospectively enrolled after giving consent. Clevidipine (0.5 mg/mL in 20% lipid solution, which was to be initiated at 10 mg/h and titrated to effect) was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.|
744124|NCT00952068||
744125|NCT00951912|the recruitment period last about half a year,and the types of location are clinic of endocrinology and nutritional clinic|
744126|NCT00951899|Participants with type 2 diabetes on monotherapy with Metformin were recruited by advertisement from 2009 to 2010 at Mayo Clinic in Rochester, Minnesota.|39 subjects provided written informed consent to participate. One subject lost intravenous access during the baseline study and withdrew consent. The remaining 38 were randomized.
744127|NCT00951821||
744128|NCT00951808|In the period June 2009 - June 2010, 237 subjects from 25 sites were enrolled in the feasibility study. Of 237 enrolled, only 10 were randomized (six subjects in the Standard Care Arm and four subjects in the Transfusion Arm). The randomization trial has been terminated due to the lack of enrollment.|
744129|NCT00951665|This study was conducted from 21 Jul 2009 to 04 Jun 2013 at 5 centers (4 centers for Phase Ib and 5 centers for Phase IIa) in the United States.|
744130|NCT00951561||
744162|NCT00950183||The study was terminated before patients were randomized to the treatment arms. Thus, it is not possible to report the results for the individual treatment arms.
744131|NCT00951509|The Institutional Review Boards of the Veteran Affairs Pittsburgh Healthcare System and the University of Pittsburgh approved the protocol for this research study. Participants were recruited at the 31st National Veterans Wheelchair Games (NVWG), VA Wheelchair clinic, and the UPMC Center of Assistive Technology.|
744132|NCT00951496|The study was opened for accrual on July 27, 2009. Target accrual was about 1500 patients. The study was closed to enrollment on Nov 30, 2011 after enrolling 1560 individuals.|Eligibility was verified by a web-based procedure which reviewed all eligibility criteria prior to each subject's registration. Prior to treatment randomization patients were stratified by stage of disease and size of residual disease.
744133|NCT00951483|Ninety-one individuals were consented and 47 participants received study drug while 44 participants enrolled as healthy control participants between July 2009 and October 2011. Participants were recruited using physician solicitation and advertisements.|
744134|NCT00951379|Recruitment Period: first participant accrued July 12, 2010 and the last participant accrued on September 10, 2013. Recruitment done in medical clinic settings across the United States, at the European Institute of Oncology in Milan, Italy, and at the BC Cancer Center, Vancouver, British Columbia, Canada.|Of the 99 participants screened during recruitment phase, 47 participants failed screening and were excluded from the trial before assignment to groups. Due to slow accrual, the study was terminated in September 2013.
744135|NCT00951275||
744136|NCT00951171|All patients recruited were women scheduled previously for IUI for treatment of unexplained infertility at the WIHRI office.|2 patients in the occlusion group experienced pain and were immediately transferrred to the standard group,thereby creating an apparent discrepancy in numbers
744137|NCT00951093|"126 consecutive patients were assessed on site (Gastrobese Clinic) between March and October 2007, 94 met the criteria.
~8 patients were lost to follow-up, 4 before and 4 after GBP. Out of those, 15 were lost to follow-up and 18 refused to follow through, resulting on the actual 53 patients."|
744138|NCT00951080||
744139|NCT00951041||
744140|NCT00951015|Randomization Phase participants received Dolutegravir (DTG 10, 25 or 50 milligrams[mg]) with Placebo/Efavirenz (EFV) for 96 Weeks . DTG participants who completed 96 Weeks continued or were switched to receive DTG 50 mg in Open label phase until DTG was locally available.|A total of 278 par were screened of which 70 were screen failures and 208 were randomized; 205 received at least one dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population. 17 participants out of 155 from DTG arm withdrew during Randomization phase and total 138 participants were enrolled in an Open-label phase.
744141|NCT00950963|Recruitment of patients began in September 2005 from one community clinic. Study nurses attempted to contact all patients in the control group at the beginning of the study only if they had not had an LDL level in the previous 12 month. An LDL level was obtained to be used as baseline.|Patients were randomized directly from a registry.
744142|NCT00950950|This study was conducted at a single center in the United States.|Participants were equally randomized to receive romosozumab or placebo.
744143|NCT00950937||
744144|NCT00950911|Subjects recuited in this open-label extension study were those who were enrolled in the 2 parent (phase 3, randomized, double-blind, active-controlled) studies 20050103 (NCT00321620) or 20050136 (NCT00321464) at sites in the Czech Republic and United Kingdom.|
744145|NCT00950872|Between November 24, 2009 and March 29, 2010, a total of 29 patients were consented and screened for potential study participation at one institution (Duke University). Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.|Subjects were evaluated for pre-operative and intra-operative eligibility criteria prior to enrollment.
744146|NCT00950859|Participants recruited initially to Cohort I and subsequently to Cohort II. Recruitment to Cohort I was closed 9 months before recruitment to Cohort II was opened. Recruitment was not randomized.|
744147|NCT00950833||Out of the 466 subjects enrolled in the study, 5 subjects were not included in the Total effective cohort as they did not meet eligibility criteria. Out of the 461 subjects enrolled in the Total effective cohort, 18 subjects were not included in the Total vaccinated cohort as these subjects withdrew before the first vaccination visit (Visit 2).
744148|NCT00950807||Participants (par.) who were eligible completed a 4- to 7-day Run-in period prior to randomization. The treatment (trt) phase was comprised of three 14-day trt periods. Par. were randomly assigned to receive a sequence of placebo and 2 of the 9 active trts over the trt phase. Participant Flow data are presented by treatment rather than sequence.
744149|NCT00950755||Participants (par.) received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases (Ph.): Ph. 1, dosimetric dose; Ph. 2, therapeutic dose. Par. were evaluated until disease progression, they died, or they were on study for 2 years. Par. completing 2 years of study could enter a long-term follow-up study (BEX104528; NCT00240578).
744150|NCT00950742|This was an open-label dose escalation study using a standard 3+3 dose escalation design, dose cohorts are presented here.|
744151|NCT00950729|march 2007 to june 2007 recruitment was done at the CHUS|
744152|NCT00950690|Investigative sites|
744153|NCT00950664|Participants recruited from movement disorder clinics at 7 hospitals in Korea, between August 2009 and March 2010.|103 participants recruited; 103 screened, 1 excluded (1 refused participation).
744154|NCT00950651||
744155|NCT00950612||
744156|NCT00950599||
744157|NCT00950365|Patients with platinum-treated metastatic non squamous NSCLC randomly assigned 1:2 to pemetrexed alone (500 mg/m^2 provided iv on day 1) or pemetrexed followed by erlotinib (150 mg provided orally daily on days 2-17) every 21 days.|
744158|NCT00950352||
744159|NCT00950300||A total of 833 participants were screened, out of which, 596 participants were enrolled into the study.
744160|NCT00950248|Between November 1, 2009 and July 23, 2015, 85 patients were assessed for eligibility and enrolled into the IPPoMS trial at National Institutes of Health, Bethesda, MD|
744161|NCT00950235|English speaking, obese, age 18 or older receiving pregnancy care at an prepaid health plan clinic. Less than 21 weeks gestation. Recruitment November 2009-July 2011.|Women were invited to attend an informational meeting which explained the study and covered the elements of consent. Interested volunteers were asked to come back to the research setting for the baseline visit. Randomization occurred at the baseline visit after a final review of eligibility and signing a consent.
744200|NCT00947791||
744163|NCT00950170|A total of 23 participants were enrolled in this non-randomized open-label study & they received ReFacto albumin free (AF) at dose & frequency prescribed by each participant's treating physician as per local standard of care & in accordance with summary of product characteristics (SmPC). Participants were expected to be in study for about 26 months|The study was conducted at 11 centers across various countries. Participants less than 6 years of age with severe hemophilia A (FVIII activity in plasma [FVIII:C]<1%) who had not received any prior factor products or blood products for their hemophilia A were enrolled in this study.
744164|NCT00949988||
744165|NCT00949975|First patient enrolled 13 July 2009. Last patient completed 05 August 2010. Study conducted at 138 centres in 12 countries (Australia, Canada, Germany, Japan, Korea, Philippines, Poland, Russia, Slovakia, Taiwan, Ukraine and US)|Patients were stabilised on maintenance therapy (tiotropium, 18 micrograms od) during a 2-week run-in period before randomisation.
744166|NCT00949910||
744167|NCT00949884|Participants were enrolled at 119 out-patient centers throughout the U.S.: 1976 patients were screened, 1632 were enrolled, and 941 randomized.|Prior to group assignment was a 2-9 day screening period and a 3-4 week single-blind (participant was blinded) placebo run-in period. Participants were randomized in an 8:1:9 ratio to treatment arms as listed.
744168|NCT00949715|Study was open to subjects that were previously enrolled in the original randomized Optimize RV Selective Site Pacing Clnical Trial (ORV)(NCT00422669) who consented between October 2009 through April 2011|Two of 67 subjects were excluded due to non-compliant programming.
744169|NCT00949702||
744170|NCT00949650||Two-arm, randomised (2:1 ratio), open-label, active-controlled, parallel-group comparison. 345 patients were randomised, 5 patients were not treated: 4 patients were not eligible for treatment and 1 patient in the chemotherapy arm refused to take study medication.
744171|NCT00949533||Out of 199 participants, 162 were considered as screening failures, mainly due to the negative result detected by the quick test for Influenza A Antigen. Therefore, 37 participants included in the study.
744172|NCT00949403||
744173|NCT00949325||
744174|NCT00949234|Two community-based sites, Jeffrey Goodman Clinic and The OASIS Clinic, will serve as facilities at which participants may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases.|
744175|NCT00949117||
744176|NCT00949078||51 participants underwent screening history and laboratory evaluation. Of those, 14 underwent a screening food challenge and were randomized to subsequent arms.
744177|NCT00948974||
744178|NCT00948935||
744179|NCT00948922|Participants were enrolled at Moffitt Cancer Center August 2009 through April 2015.|
744180|NCT00948896|Convenience sampling was used to enroll a cohort of 600 infants 4-5 months of age from the Tororo District Hospital Maternal and Child Health clinic between June 2010 and July 2011.|"Of the 400 HIV-unexposed infants, 7 were excluded prior to randomization for inability to comply with study protocol.
~Of the 200 HIV-exposed infants, 14 were excluded prior to randomization for the following reasons: 7 tested HIV positive; 3 unable to locate for > 60 days; 2 withdrew informed consent; 1 died; 1 unable to comply with protocol."
744181|NCT00948857||
744182|NCT00948818|Patient recruitment occurred over an eight month period from July 2009 to March 2009 at 118 study sites (111 in the United States, 7 in Canada).|Patients went through a 14 to 21 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS). All randomized patients needed an abdominal pain score ≥ 3. One randomized patient in the Placebo arm did not receive study drug.
744183|NCT00948792||
744184|NCT00948766||One patient in each treatment group in the core study and one patient in the treatment group in the extension study did not receive study medication; they were not included in the safety set.
744185|NCT00948688||
744186|NCT00948675||
744187|NCT00948610||
744188|NCT00948506||
744189|NCT00948441|Children at our hospital with central venous access for parental nutrition and at least 3 CRBSI in the past 6 months were recruited. Patients had to be at least 6 months old and <21 years and be able to have a minimal dwell time of 4 hours. Exclusion criteria: known immunodeficiency or allergies to ethanol or heparin.|Randomized to one of two study groups. group 1 - ethanol lock followed by washout period followed by heparin lock. group 2 - heparin lock followed by washout period followed by ethanol lock.
744190|NCT00948428||
744191|NCT00948389||Of 28 participants enrolled in this study, 26 received treatment.
744192|NCT00948298||
744193|NCT00948246||
744194|NCT00948155|Recruitment occurred in a research laboratory in a school of medicine. Dates of recruitment: first participant first visit March 31, 2009; last participants last visit December 02, 2010|"48 participants signed consents and were enrolled in the study. Medical clearance was achieved by 41; 29 returned for the first laboratory visit which is the first day drug/placebo was administered. The 12 who did not return for the Day 1 visit were not included further in the study.
~There was a minimum 14 washout period between drug conditions."
744195|NCT00948090|A multicenter (43 trial sites in United States and Canada), single-arm, open-label, phase 2 exploratory trial to evaluate clinical outcomes following pharmacokinetic (PK)-directed intravenous (IV) busulfan therapy in 207 participants with Non-Hodgkin's and Hodgkin's lymphoma were evaluated.|Test dose of 0.8 mg/kg of IV busulfan was administered (2-hour continuous infusion) 1 day between Days -14 and -11 for PK analysis to inform subsequent dosing. The conditioning regimen consisted of IV busulfan on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
744196|NCT00948064|Recruitment Period: September 08, 2009 to March 20, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 110 participants enrolled, 31 were enrolled in the Phase I portion of the study and 79 were enrolled in Phase II part of the study.
744197|NCT00948025|Recruitment began on 22 June 2009 and ended on 23 May 2012.|
744198|NCT00947882|Patients who met the eligibility criteria were randomised in a 1:1:1:1 manner to 1 of the 4 treatment groups in this trial. The randomisation was stratified by region (North America and Europe) and prostate volume (<30 mL and ≥30 mL). 404 patients were randomised and received a single dose of placebo, 10 mg, 20 mg, or 30 mg degarelix.|
744199|NCT00947856|Jul 2009 - Mar 2013|
744201|NCT00947765|"Participants were selected by interview and clinical examination and Consent was taken.
~Location: Out patient department of KLES Dr. Prabhakar Kore Hospital & MRC, Belgaum.
~Period: January 1st, 2007-December 31st, 2007. No blinding procedure was followed. Randomization: participants were assigned into two groups according to randomization table."|
744202|NCT00947752|Subjects were randomly assigned in a 1:1 assignment ratio to one of two drug sequences. Subjects were to manually inject GA (F1 or F2) once daily for 14 days then cross-over to the other formulation for another 14 days of treatment, including a 7-day run-in period on F1 treatment for all participants to assess daily diary compliance.|To ensure the standardization, all study sites were instructed to train subjects to complete the daily diary, with special attention to the Visual Analog Scale (VAS) used to measure pain.
744203|NCT00947661||
744204|NCT00947544||
744205|NCT00947531|Date of recruitment period: 24-Oct-2006 - 02-Feb-2007 Type of location: Hospitals, Medical Universities, Medical Military Academy, Research Institutes|Patients were excluded from the trial before assignment to a group when not all inclusion criteria were met or when exclusion criteria were applicable.
744206|NCT00947518|from August 2005 to February 2006 at the tertiary level neonatal intensive care unit of All India Institute of Medical Sciences, New Delhi|Infants with one minute Apgar score <4, hemodynamic instability, congenital malformations, generalized skin disorder and who needed respiratory support (continuous positive airway pressure and/or intermittent mandatory ventilation) were excluded
744207|NCT00947505|Male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-Iv, with Norwood Hamilton Classifications of IIa-V, have active hair loss with the last 12 months|Exclusion Criteria: Individuals with photosensitivity to laser light, histor of any malignancy in target area. Also, use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to baseline and use of retinoids in past year, chronic dermatological condtion (eczema , psoriasis, infection, etc.) of the scalp other than male pattern baldness
744208|NCT00947427||
744209|NCT00947349||
744210|NCT00947310||
744211|NCT00947297||
744212|NCT00947284|Recruitment details unavailable due to death of investigator|Pre-assignment details unavailable due to death of investigator
744213|NCT00947271||
744214|NCT00947219|Male subjects who have been diagnosed with androgenetic alopicia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types i-IV and Norwood Hamilton Classifications of IIa to IV and have active hair loss with the last 12 months|Exclusion criteria: Individuals with photosensitivity to laser light, history of any malignancy in target area, has used phytotherapy (e.g. saw palmetto) with 8 weeks prior to baseline. Subjects who has chronic dermatological conditions (eczema, psoriasis, etc) of the scalp other than male pattern baldness
744215|NCT00947193|In this study, participants with HA or HB due to a nonsense mutation were recruited for the study.|Participants requiring treatment with Factor 8 (FVIII)/Factor 9 (FIX) concentrate during 14-day ataluren treatment could continue ataluren treatment for at least 14 days following discontinuing FVIII concentrate treatment for hemophilia type A (HA) and for at least 18 days following discontinuing FIX concentrate treatment for hemophilia type B (HB)
744216|NCT00947167||
744217|NCT00947154||
744218|NCT00947115|This study was conducted at six centers in Germany and Poland.|Out of the 525 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 524.
744219|NCT00947011|Although 12 participants were enrolled in this study, their assignment to a specific Arm/Group is unknown, as the PI has left the institution and no further data (if any) is available.|
744220|NCT00946998||
744221|NCT00946985|This trial was intended to recruit patients from multiple sites in North America, Europe, and Asia.|Eligible patients were to be treated with paliperdione palmitate for up to 25 weeks (stabilization phase). Patients meeting stabilization criteria were to be randomized to either paliperidone palmitate or oral risperidone and be treated for 24 months (relapse prevention phase).
744222|NCT00946920|Subjects who met the eligibility criteria were randomized to degarelix or goserelin acetate treatment in a 2:1-ratio. 859 subjects were randomized but 11 subjects did not receive any treatment.|
744223|NCT00946881|"Thirty patients were included in the study by five different centers in the US. All 30 patients received the entire VTP procedure (first treatment phase).
~Two of them discontinued the study prior to Month 12. Eight patients who had positive biopsies at Month 6 entered in the retreatment phase. Only 7 of them actually received retreatment."|
744224|NCT00946712||
744225|NCT00946647|In phase l a total of 31 patients were treated with escalating dose of PAN, 20 mg 30 mg & 40 mg. In phase ll a total of 82 patients were actually randomized with 40 patients assigned to PAN+5-Aza and 42 patients assigned to 5-Aza.|"For phase I, approximately 26 patients were planned to be enrolled in cohorts of at least three MTD evaluable patients per dose level.
~For phase ll, approximately 80 patients were planned to be enrolled, 40 patients per arm."
744226|NCT00946530|Participants were recruited from the local community, from 2004-2008|diagnosis changed for 2 care-recipients, so 2 dyads were not included in the final analysis.
744227|NCT00946478||
744228|NCT00946348|Recruitment was conducted through Dartmouth Hitchcock Medical Center, and local community mental health centers.|Of the 52 people who consented to participate in the study, 12 met eligibility criteria for the main study and were randomized. Because persons who met entry criteria received study treatment on only one day, all randomized participants completed the study.
744229|NCT00946322||1 couple was excluded due to discovery that they did not meet eligibility requirements
744230|NCT00946309|Recruitment occurred from July 2010 to April 2014 at the VA Puget Sound Health Care System.|There were no pre-assignment events. Group assignment occurred at the time of participant enrollment.
744231|NCT00946296|Between October 2005 and April 2013, subjects who had been determined to undergo thyroidectomy for definitive management of Graves Disease, were approached for participation in the study. Recruitment occurred in the endocrine practices of the investigators.|
744232|NCT00946270|Recruitment Period: July 2009 to March 2013.|
744233|NCT00946192||
744234|NCT00946153|Participants took part in the study at 12 sites in Japan and 2 sites in South Korea from 24 Jul 2009 to 13 Aug 2015.|
744235|NCT00946114||
744236|NCT00946101|Study participation began once written informed consent was obtained. The first and last dates of informed consent were 03 Aug 2009 and 19 Aug 2009. Once informed consent was obtained, a subject identification number was assigned using an interactive voice response system, and screening evaluations began to assess study eligibility.|Eligible subjects were randomly assigned in a 4:1 ratio to receive 2 doses of study monovalent vaccine or placebo by intranasal spray; the doses were administered approximately 28 days apart, on Days 1 and 29.
744237|NCT00946088|Patients were enrolled from November 2010 through February 2011.|
744238|NCT00946023||52 participants were screen failures and did not proceed on the study.
744239|NCT00945958|"This study was an extension study of previous study conducted by SPARC (CLR_09_12).
~This was open-label, single group assignment long-term safety study.
~A total of 161 subjects were enrolled in this study.
~From the start of the study through Week 24 (Visit 7), safety endpoints (TEAEs and change introocular pressure) were evaluated"|Subjects received their first dose of the study drug at Visit 1 (Baseline Visit). A total of 149 subjects completed Study Visit 7 (End-of-Evaluations), which met FDA's recommendation of providing safety data for at least 100 subjects for at least 6 months.
744240|NCT00945945||Due to a study drug labeling error which led to a treatment crossover, the intended comparisons for group-level differences between duloxetine and placebo cannot be made. The results from comparisons of mixed-treatment groups are presented for primary efficacy and safety outcomes.
744241|NCT00945906||
744242|NCT00945893|Subjects were screened for the study within 14 days prior to randomization. The first and last dates of informed consent were 03 Aug 2009 and 18 Aug 2009. Once informed consent was obtained, a subject identification number was assigned using an interactive voice response system, and screening evaluations began to assess study eligibility.|Eligible subjects were randomly assigned in a 4:1 ratio to receive 2 doses of monovalent vaccine or placebo by intranasal spray; the doses were administered approximately 28 days apart, on Days 1 and 29.
744243|NCT00945854||
744244|NCT00945815||
744245|NCT00945750||Participants were randomized to 1 of 6 treatment sequences of 1 of 3 treatments: (1) famotidine as a film-coated tablet (FCT) taken with water, (2) famotidine as a chewable tablet (CTw) taken with water, and (3) famotidine as a chewable tablet taken without water, over 3 study periods in a crossover design.
744246|NCT00945659||
744247|NCT00945594||
744248|NCT00945555||
744249|NCT00945477|Male patients were enrolled from 7/17/2009 through 10/9/2012. All patients were from our practice and screened from our database.|
744250|NCT00945334||
744251|NCT00945321||
744252|NCT00945295|Thirty one patients with post-stroke upper limb spasticity aged 36 - 75 years were enrolled. Patients were recruited from neurology clinics and through local advertisements.|At the time of consent, all participants agreed that if they were assigned to the BoNT-A no rehab, they would not to start any new therapy or exercise program for arm spasticity until they were finished with the study.
744253|NCT00945282|A total of 8 participants with Treatment-Naive, Human Immuno deficiency virus (HIV-1) infection were randomized to the study. The study was conducted from 20 October 2009 to 28 November 2009 at one center in Argentina.|One participant was initially enrolled in the study, however withdrew consent prior to randomization. The study was planned to be conducted in 2 cohorts, however based on safety and antiviral activity of Cohort 1, a second cohort of participants was not needed and the study was stopped.
744254|NCT00945256|Young groups: Ages 18 - 40; Elderly groups: Ages 60 - 85|
744255|NCT00945243||
744256|NCT00945191|A total of 24 participants who met all inclusion criteria and no exclusion criteria were enrolled and received treatment at 3 clinic sites in the United States.|Following debulking surgery, participants with suboptimal resection (ie, residual tumor > 1 cm) and measurable/evaluable tumor by imaging techniques were eligible for participation in this study. Debulking surgery occurred within 6 weeks before enrollment in the study.
744257|NCT00945139|A total of 60 patients were screened for this study at all sites beginning March 2007. 46 patients were enrolled at the UNM Cancer Center, NYU Medical Center and NM Cancer Care Associates/Santa Fe.|
744258|NCT00945100|Between September 2009 and December 2012, 45 sites randomized 169 participants to either increase patching time to an average of 6 hours per day (n=86) or continue 2 hours daily patching (n=83).|Prior to being considered for the randomized trial, participants who had not already completed at least 12 weeks of 2 hours of daily patching were enrolled into a run-in phase and treated with 2 hours of daily patching (and spectacles if needed) with follow-up every 6 weeks until no improvement.
744259|NCT00945061||
744260|NCT00945035||
744261|NCT00945009||
744262|NCT00944749||
744263|NCT00944710|Between November 2009 and August 2013, 73 participants from 20 sites were randomly assigned to either augmenting weekend atropine by changing the lens over the fellow eye to plano (n=33) or continuing with weekend atropine with best spectacle correction (n=40).|Prior to being considered for the randomized trial, participants who had not completed at least 12 weeks of atropine were enrolled into a run-in phase and treated with weekend atropine 1% ophthalmic solution and spectacles based upon a recent cycloplegic refraction, with follow up every 6 weeks until no improvement
744264|NCT00944697|Recruitment was 13 July 2009 to 26 March 2010. There were 29 sites in General Practice, hospitals and SMOs.|Patients had to have moderate to severe pain due to diabetic/idiopathic polyneuropathy. This was shown by a pain score of >= 5 (average pain over 24 hours)and an MNSI (Michigan Neuropathy Screening Instrument) of >= 2.5 at screening. Subjects were then randomised to OXN (Oxycodone/Naloxone) or placebo.
744265|NCT00944671|The study was conducted at a single clinical research center in the US. Subjects were recruited via print advertisements and existing patient research files.|Prior to the first treatment period, Health Insurance Portability and Accountability Act (HIPAA) and informed consent were signed. For each subject a medical history was taken, physical examination and laboratory safety tests were conducted. No enrolled subjects were excluded from the trial before randomization.
744266|NCT00944658||
744267|NCT00944645||
744268|NCT00944554||
744269|NCT00944528||
744270|NCT00944450||
744504|NCT00932425|40 patients were enrolled between October 29, 2009 and May 24, 2011|
744505|NCT00932399||
744271|NCT00944229|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.|
744272|NCT00944125||Subjects are consented and randomized before the pacing prodecure. They may have been excluded (considered screen fails) if they end up not having the procedure or being identified as inappropriate once the procedure began. 50 Consented and 41 Randomized.
744273|NCT00944073|Participants were healthy pediatric males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 19AUG2009 and 9SEP2009.|
744274|NCT00944047||
744275|NCT00944034|Subjects were enrolled from 6 centres in Belgium, 4 in Czech, 24 in Germany, 5 in Italy, 16 in Spain and 4 in UK who had previously participated in and completed the study V72P12.|All enrolled subjects were included in the trial.
744276|NCT00944021||
744277|NCT00943917||At Stage II subjects divided into 6 total arms: ITCA 650 20 mcg/day assigned to either ITCA 650 20 mcg/day or ITCA 650 40 mcg/day; ITCA 650 40 mcg/day assigned to ITCA 650 40 mcg/day or ITCA 650 80 mcg/day; Ex Inj assigned to either ITCA 650 40 mcg/day or ITCA 650 60 mcg/day
744278|NCT00943878|Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 7AUG2009 and 28AUG2009.|
744279|NCT00943852|"First Patient Entered: 31-Aug-2006
~Last Patient Last Visit: 11-Dec-2006
~Number of Sites: 1"|
744280|NCT00943826||The primary completion date for co-primary outcome of Progression-Free Survival (PFS) was 31 Mar 2012, whereas, the primary completion date for co-primary outcome of Overall Survival (OS) was 28 Feb 2013. Data for PFS and OS are reported according to these cut-off dates.
744281|NCT00943800||
744282|NCT00943787|Recruitment period: 2/2006-5/2009. Recruitment included outpatients at UVA clinics, former research subjects, and local advertising. All subjects ≥18 years of age and had type 1 diabetes defined by American Diabetes Association criteria or judgment of the study endocrinologist after review of the clinical history.|
744283|NCT00943761||
744284|NCT00943735|This was a non-interventional, observational study. Study investigators contacted through prescription records in the IMS Longitudinal prescription (LRx) Database recruited symptomatic, fesoterodine-naive subjects (N=788 recruited; 774 entered) when they presented with overactive bladder (OAB) symptoms during regularly-scheduled physician visits.|The use and dosage recommendations for fesoterodine 4 milligram (mg) or 8 mg tablet taken by mouth (PO) once daily (QD) adhered completely to the approved product label and was adjusted solely according to medical and therapeutic necessity.
744285|NCT00943722||
744286|NCT00943683|Patients were recruited at 65 study centers in Africa, Asia, Europe, North America, and South America Therapy period: Aug 2000 to Feb 2001|Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit. Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines
744287|NCT00943670|Between 14 July 2009 and 4 December 2009, 51 patients from 13 study sites in the United States were enrolled and initiated treatment in the study.|All patients enrolled in the study were initially treated with single-agent trastuzumab emtansine. Participants with early progressive disease could elect to receive pertuzumab in combination with trastuzumab emtansine.
744288|NCT00943631|Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled and vaccinated between 07AUG2009 and 18AUG2009.|
744289|NCT00943605||
744290|NCT00943592||
744291|NCT00943579|Recruitment spanned from 08/09 - 10/11. Only individuals who completed 0901 (NCT00850070) were eligible to participate in this study thus recruitment was restricted to those already enrolled in that trial. When participants were at their 12-week visit for 0901 (NCT00850070) they were asked if they wanted to continue in the open label extension.|All participants who consented went straight from the randomized control trial in 0901 (NCT00850070) to entering this trial. No washout period was needed. No participants were excluded who had completed the previous trial.
744292|NCT00943488|Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 07AUG2009 and 21AUG2009|
744293|NCT00943436|20 male students attending the University of Tennessee were recruited to participate through ads and flyers posted around campus. The recruitment period started in November 2008 and ended in August 2009 upon completion of the study. The initial phone screen conducted to determine eligibility occurred in the HEAL lab.|Participants were randomly assigned to which session, exercise or rest, they engaged in first. As this is a crossover design, participants did complete both the exercise and rest conditions.
744294|NCT00943397|Patients were recruited at 27 sites in Africa, Europe, North America, and South America Therapy period: May 2001 to Mar 2003.|This was an open-label, controlled extended safety study. Patients were treated with either montelukast 4-mg oral granules or usual care. Patients who completed Protocol 176-01 had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol 176-01, could also enroll.
744295|NCT00943384||
744296|NCT00943319||
744297|NCT00943306||
744298|NCT00943202|Participants were healthy males and females, age 6 months to 17 years, recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 20AUG2009 and 21SEP2009.|
744299|NCT00943150||
744300|NCT00943124||
744301|NCT00943111|A total of 209 participants were screened, of which 46 participants were screen failure and 3 participants withdrew prior to randomization. A total of 160 participants were enrolled in this study.|All enrolled participants received eliglustat or imiglucerase in 52 week primary analysis period (PAP). After 52-weeks PAP, all participants who remained on-study, received eliglustat in the long-term treatment period (LTTP) for up to 5 years.
744760|NCT00919763||
744761|NCT00919724||
744762|NCT00919711|Participants were enrolled from 19 October 2009 through 4 January 2011|
744302|NCT00943098|Patients already scheduled for the surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal underwent a screening visit within 30 days from the scheduled date of surgery.|
744303|NCT00943072|The study was conducted at 55 study centers in the United States, Canada, Columbia, India, and Israel. The recruitment period occurred between 08 Jul 2009 and 29 Apr 2010.|273 participants were screened, 189 randomized, and 188 were included in the Safety Analysis Set (SAF). The Full Analysis Set (FAS) included 187 participants with at least one post-baseline assessment.
744304|NCT00942994||
744305|NCT00942968||
744306|NCT00942903||
744307|NCT00942890||There was a total of 44 participants.
744308|NCT00942851||
744309|NCT00942825||
744310|NCT00942786||
744311|NCT00942734|Recruitment Period: July 17, 2009 to February 08, 2013. Recruitment was done in various medical clinics in the United States.|Of the forty-nine participants registered, six participants were ineligible and not treated.
744312|NCT00942708||
744313|NCT00942604|The study period was 22 July 2009 (first patient randomized) to 14 October 2009 (last patient completed Day 57).|
744314|NCT00942578||
744315|NCT00942448|Patients already scheduled for the surgical extraction of a single fully or partially impacted mandibular 3rd molar underwent a screening visit within 30 days from the scheduled date of surgery.|Patients under treatment with other analgesics, Major or minor tranquillizers, Muscle relaxant, Antihistamines, MAO inhibitors or corticosteroids had to undergo a wash out period prior to inclusion in the study.
744316|NCT00942422||
744317|NCT00942409||
744318|NCT00942357|GOG 0258 accrued 813 patients between June 29, 2009 and July 28, 2014.|
744319|NCT00942331||
744320|NCT00942266||
744321|NCT00942188||
744322|NCT00942175|Participants enrolled at one site in the United States from 15 December 2009 to 08 July 2010.|Healthy participants were enrolled in one of 4, once-daily (QD), proton pump inhibitor (PPI) treatment groups.
744323|NCT00942162||During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the patients and signing informed consent forms. While 125 subjects were enrolled, only 123 started the study, as 2 subjects did not receive treatment and were excluded.
744324|NCT00942149|A total of 20 participants were enrolled in the Duke NICU over a period of 18 months.|
744325|NCT00942084|Total enrollment is 32. 32 for safety analysis and 30 in PK population (28 included in final PK analysis).|
744326|NCT00941993||
744327|NCT00941928|Recruitment Period: July 14, 2009 to December 6, 2010. All recruitment occurred at The University of Texas (UT) MD Anderson Cancer Center.|
744328|NCT00941889|Patients were recruited during office visits.|
744329|NCT00941863|The study was conducted at 3 centers in the US: the University of Wisconsin, the University of Pennsylvania, and Vanderbilt University. Enrollment began 01 Jul 2002.|Expansion in this context is an increase in the number of patients exposed to the recommended dose for this combination. The purpose of the increase was also to test efficacy signals in Metastatic Melanoma (MM).
744330|NCT00941798||2283 patients were screened. 1518 patients were randomized.
744331|NCT00941733||
744332|NCT00941720||
744333|NCT00941681||
744334|NCT00941668|subjects were recruited by the PI at the clinical site|
744335|NCT00941655||
744336|NCT00941603||
744337|NCT00941330|From June 2009 to December 2014, patients were recruited at Winship Cancer Institute of Emory University, Emory University Hospital Midtown, and Grady Health System, all in Atlanta, Georgia.|Five patients were not assigned to a treatment arm. One patient was ineligible for the study due to a low Oncotype score. Three patients did not like randomized treatment. One patient had disease progression.
744338|NCT00941304||
744339|NCT00941070|Patients were recruited from local medical clinic from July 2009 through November 2011|
744340|NCT00941031||
744341|NCT00941005||
744342|NCT00940992||
744343|NCT00940927|Participants were recruited from our asthma research clinic database or newspaper advertisements. Participants were recruited from 07/1993 to 10/1994.|Participants had to withhold inhaled short-acting beta2 agonist or inhaled anticholinergic drugs for 8 h, oral antihistamines for 5 days, theophylline for 24 h, and cromolyn, nedocromil, and inhaled corticosteroids for 2 h prior to the study.
744344|NCT00940901||
744345|NCT00940888||
744346|NCT00940875||
744347|NCT00940823||
744348|NCT00940771|Pediatric patients with elevated cholesterol were recruited from a Pediatric HIV Clinic between April 8, 2009 and May 1, 2013.|
744349|NCT00940602|1 patient rand. to deferasirox arm did not receive study drug & was excl. from the Safety set. Terminated by Sponsor: Patients who had completed at least 3 years of on-treatment period including 28-day follow-up & were still on trial when end-of-study definition (3 years after LPFV) was reached & therefore, the study was terminated as per protocol|The planned sample size of 210 patients randomized in a ratio of 2:1 in favor of deferasirox was based on the feasibility of enrolling the patients and consultations with the Health Authorities.
744350|NCT00940589||
744351|NCT00940576||
744352|NCT00940537|Subjects were recruited through the Center for Human Nutrition (CHN) beginning in July, 2009. Many had previously been enrolled in other CHN studies. The final subject was tested in December, 2009.|All enrolled subjects completed the study.
744353|NCT00940498||The study was conducted in two parts: Part 1 to determine the maximum tolerated dose (MTD) and Part 2 to confirm the MTD. As per the sponsor's decision, data was reported for the combined population of Part 1 and Part 2 which was considered more informative.
744354|NCT00940485|A total of 332 participants were enrolled in this study conducted from 28 April 2009 to 23 December 2011 at seven centers in China.|Of 332 participants, 200 were randomized, out of which 97 participants were assigned to Peginterferon alfa-2a + entecavir and 100 were assigned to entecavir, and three participants did not take any study drug.
744355|NCT00940446||
749753|NCT00671853||The study consent 120 subjects. However, 29 subjects were considered screening failures and were not randomized.
744356|NCT00940342|Recruitment Period: October 2004 through January 2007. Of the 130 participants recruited, 119 participants were recruited at The University of Texas (UT) MD Anderson Cancer Center, 6 at The University of California San Diego, and 5 participants were recruited at Dana Farber Cancer Institute.|
744357|NCT00940316|The study opened for accrual on July 9, 2009 with an accrual goal of up to 96 patients. The study was designed to enroll 13 patients on each arm and do an interim efficacy assessment. Accrual was suspended on March 31 2015 fand closed permanently on April 13, 2015 with 28 patients enrolled on the study.|Subjects with either 6/6 UGT1A1 genotype or 6/7 UGT1A1 genotype will be randomized into either Arm A and Arm B. Subjects with 7/7 UGT1A1 genotype enrolled in Arm C.
744358|NCT00940290|Pediatric residents, pediatricians and sub-specialists were recruited from their clinical practices to participate in the study. All in known teaching hospitals in Monterrey and Mexico city. Recruitment from September 1st to October 21st.|Participants were not eligible for randomization if they refuse to participate in the trial or if they reported less than six months of clinical practice (residents). After randomization they were allocated to one of the four study groups. A survey was applied and no wash out was observed or desertions.
744359|NCT00940108||One randomized participant withdrew consent prior to vaccine administration and was not included in the participant flow data or in any analysis population.
744360|NCT00940017||
744361|NCT00939991|Patients must have histologically confirmed diagnosis of malignant glioma (Grade 3 or 4 for Phase I and only Grade 4 for Phase II) and radiographic evidence of recurrence or disease progression following prior therapy.|
744362|NCT00939952|Patients were recruited from an outpatient dialysis center. Eligible patients were referred to study investigators by social workers or nurses.|All study patients were assigned to receive study drug to explore the pharmacokinetic profile of ertapenem during CAPD. Once enrolled, patients were excluded if they developed infection.
744363|NCT00939900||
744364|NCT00939874||
744365|NCT00939822|Asymptomatic middle-aged adults (ages 40-72 years) with parental history of AD were recruited from the community through local memory clinics, newsletters, educational talks, booths at health fairs, and newspaper and magazine advertisements.|Screened individuals were not randomized to drug or placebo if they withdrew consent, were unable to complete baseline procedures or no longer met inclusion criteria.
744366|NCT00939809|The study was activated on 7/6/2009 and closed to accrual on 1/4/2010.|
744367|NCT00939796|Eligible patients presenting to the clinical practice and for whom tympanostomy tube (TT) insertion was recommended were offered the opportunity to participate in the study. Recruitment period was May-June 2009.|Investigators treated a minimum of 1 subject (or 2 ears) as lead-in procedures prior to enrolling test cohort. 3 lead-in subjects were enrolled and were required to meet the same eligibility criteria and protocol-required procedures as the test cohort. Lead-in efficacy data have been separately analyzed. 13 subjects enrolled in the test cohort.
744368|NCT00939783||
744369|NCT00939770||
744370|NCT00939731||
744371|NCT00939705||
744372|NCT00939692||
744373|NCT00939653||
744374|NCT00939640|22 patients screened, 14 enrolled|
744375|NCT00939627|Southeast Phase II Consortium (SEP2C) study enrolling participants at seven participating sites during August 2009 through October 2011.|Fifty-five patients were consented and assigned to a treatment arm; 3 withdrew before treatment. Fifty-two patients were treated on study. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
744376|NCT00939562||
744377|NCT00939536||healthy, normal subjects
744378|NCT00939523||
744379|NCT00939510|Patients were recruited from November 2005 to April 2009 from medical clinic|
744380|NCT00939484|This study was distributed to the sites on June 18, 2009, and received the first IRB approval on July 20, 2009. The study was closed to accrual on December 07, 2012. Thirty two (32) patients have been enrolled to the study, Last patient went off treatment in October 2013.|Total 32 patients were registered on this study, 8 in Stratum A, 21 in Stratum B and 3 in Stratum C. One patient in Stratum B was declared ineligible.
744381|NCT00939471||
744382|NCT00939393|Eligible patients presenting to the study sites (medical clinics) for whom endoscopic sinus surgery was recommended were offered the opportunity to participate in the study by study investigators.|
744383|NCT00939367||healthy, normal subjects
744384|NCT00939341|A total of 1022 asthma patients were enrolled at 51 sites in 5 Asian countries: China (21 sites), India (12 sites), Indonesia (3 sites), Thailand (6 sites) and Taiwan (9 sites) during the period July 2009 to August 2010. Of the 1022 enrolled, 862 participants entered into a 12-week treatment with the investigational drug.|The study consisted of an initial screening visit followed by a 2-week run-in period before a 12-week treatment with investigational drug.
744385|NCT00939211|The study has been performed at four centers in Sweden. The first subject entered the study on 23 June 2009 and the last subject completed the study on 6 November 2009.|
744386|NCT00939198||
744387|NCT00939185||
744388|NCT00939159|Recruitment Period: August 05, 2009 to March 10, 2011. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the seventeen (17) participants enrolled, four were excluded prior to receiving treatment on the study.
744389|NCT00939120||
744390|NCT00939107|We recruited patients from September 2003 through May 2007 among those referred for treatment at a primary care specialist centre in Copenhagen, Denmark.|1969 Patients were screened for eligibility. 1619 Were excluded (580 Were unable to speak and understand Danish, 252 Had comorbidity, 224 Had no peripheralization or centralization, 101 Had previous surgery, 87 Could not be examined, 165 other reasons, 210 Declined to participate)
744391|NCT00939094|This multicenter study was conducted between August 2009 and November 2010 in the United States.|The study had an enrolment phase of up to 35 days (including washout and baseline periods), a 28-day treatment phase, and a follow-up phase of 7 days (for men and women not of childbearing potential) or 28 days (for women of childbearing potential). Patients randomized to AZD2066 received AZD2066 12 mg from Days 1 to 4 and 18 mg from Days 5 to 28.
744392|NCT00939055||
744393|NCT00939029||
749754|NCT00671788|The study was activated on 6/2/2008 and closed to accrual on 4/12/2010.|
749755|NCT00671749||
744394|NCT00939003||A total of 192 participants were enrolled at 37 study sites in Australia, Belgium, Canada, the Czech Republic, France, Germany, the Netherlands, Spain, the United Kingdom, and the US. Due to Investigator non-compliance with protocol requirements, 1 study site was closed; the 7 participants enrolled at this site were excluded from efficacy analyses.
744395|NCT00938964|550 participants consented; 478 participants were randomized.|
744396|NCT00938886|Participants were recruited from Providence, RI and the surrounding community through bulletin board, radio, internet, newspaper, and public transportation advertisements.|
744397|NCT00938860||This was an 80 week multicenter randomized, open label, controlled study in adult HCVpositive maintenance liver transplant recipients. Patients were randomized at a 1.3:1 ratio to CsA and tacrolimus. Patients randomized to tacrolimus were maintained on treatment with tacrolimus, patients randomized to CsA were converted from tacrolimus to CsA
744398|NCT00938782|Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups.|
744399|NCT00938717|Patient recruitment occurred over a fifteen month period from July 2009 to September 2010 at 111 US study sites.|Patients went through a 14 to 21 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS). All randomized patients needed an abdominal pain score ≥ 3.
744400|NCT00938704||
744401|NCT00938639||
744402|NCT00938548|"This study was approved by the Institutional Ethics Committee of Yonsei University Medical Center.
~Datas were collected between June and December 2009."|"Of a total of 78 patients assessed for eligibility, 70 subjects received pregabalin or placebo after randomization.
~Eight patients were excluded because some patients refused to participate and some patients have psychiatric disorder and insulin-dependent DM."
744403|NCT00938470|Seventy-three participants were enrolled between January 2010 and July 2012.|Seven participants from arm I were enrolled in the early toxicity evaluation portion. Additional sixty-six participants were randomized to arm I or II on the phase II portion of the study. There were 11 cancellations (5 arm I, 6 arm II) and these participants were excluded in all analyses.
744404|NCT00938457|Three patients were recruited at Mayo Clinic between January 2010 and May 2010.|This was a phase I/II trial. A total of 3 participants were accrued, all to the phase I portion. This trial was terminated due to poor accrual. No patients were accrued to the phase II portion. No results from the phase II portion are available.
744405|NCT00938431|The SP0847 study began recruitment in October 2009. The study ended in July 2014 with 47 subjects enrolled into the study.|
744406|NCT00938392||Two subjects enrolled in the study did not receive any vaccination, and as such are not accounted for as started.
744407|NCT00938366||This was a crossover study.18 subjects were included and washout of 10 to 25 days separated each treatment period. Overall 17 subjects completed the trial.1 subject withdrew consent after completion of the first period (cladribine alone) and was excluded from Pharmacokinetic population.18 subjects were included in safety population.
744408|NCT00938340|Participants were recruited through advertisements in the local newspaper and university e-mails from April 2008 to October 2008.|Of the individuals (n=246) who were contacted and screened with a semi-structured telephone interview, 50 qualified and were scheduled for a screening visit at the Penn State General Clinical Research Center. After written informed consent was obtained, a fasting blood sample was drawn. Eligible participants (n=20) were randomized to the study.
744409|NCT00938327||
744410|NCT00938314||
744411|NCT00938041||
744412|NCT00938015||
744413|NCT00937950||Out of the 2022 subjects enrolled in this study, 19 were excluded for reasons of non-eligibility, hence only 2003 started the study.
744414|NCT00937937||
744415|NCT00937859||
744416|NCT00937833||
744417|NCT00937794|This screening study evaluated patients for disease and neurodevelopmental status to determine their potential eligibility for investigational study HGT-HIT-045 (NCT00920647), and informed decisions regarding study design, rate of enrollment, and estimated dates of completion for subsequent investigational studies in Hunter syndrome.|
744418|NCT00937768|Sixteen (16) participants were recruited at Mayo Clinic (Rochester) between July 2009 and June 2012.|This trial was terminated early due to funding issues.
744419|NCT00937560||
744420|NCT00937547|Samples were collected from files between 2001-2011|14 samples were excluded because of misdiagnosis.
744421|NCT00937521||
744422|NCT00937495|Sixteen patients were accrued to this study from June 2009 through July 2010.|One participant received commercial drug instead of study drug and was deemed a violation. Another participant did not have a post baseline measurement scan and by protocol is not evaluable for the primary endpoint. These patients were excluded from the primary endpoint analysis. Therefore, 14 participants were evaluated for each endpoint.
744423|NCT00937404||
744424|NCT00937391|The date of the first participant, first visit was 21 Jan 2010. The date of the last participant, last visit was 09 Sep 2010. The date of the Blinded Read for Stage 1 was 27 Apr 2010. the date of the Blinded Read for Stage 2 was 08 Sep 2010|A subject was enrolled in EITHER Stage 1 or Stage 2 and not both. Overall for both stages, 61 participants were Screened, 7 were Screen Failures, and 54 participants were enrolled and treated of which 53 participants completed the study (20 unique participants in Stage 1 and 33 unique participants in Stage 2)
744425|NCT00937378||
744426|NCT00937326|The study was planned on 225 male and female participants with type 2 diabetes (T2D) on an existing, stable, background metformin therapy, aged 30 to 70 years, at 45 centers of Bulgaria (7), Estonia (1), Hungary (4), Poland (4), Romania (6), Russia (13), United Kingdom (3) and Ukraine (7) from 19 August 2009 to 18 September 2010.|Out of 527 participants screened, 227 with glycosylated hemoglobin A (HbA1c) of >=7.5% and <= 10.5% and a fasting glucose (FG) >=160 and <=240 milligram per deciliter (mg/dL) were randomized in 1:1:1:1:1 to oral dose of placebo or any one of 4 doses of SRT2104 (0.25, 0.5, 1.0 or 2.0 gram per day [g/day]), once a day for 28 consecutive days.
744427|NCT00937235|Participants were recruited through advertisements and referrals to the University of Pennsylvania's Center for the Treatment and Study of Anxiety (CTSA), Transdisciplinary Tobacco Use Research Center (TTURC), and the Philadelphia VA Hospital.|
749756|NCT00671723||
749757|NCT00671671||
744428|NCT00937157|Recruitment from the pool of relapsing-remitting multiple sclerosis patients (RRMS) at the Jacob's Neurological Institute (JNI) was open for approximately one year.|All enrolled patients had to meet all inclusion criteria and no exclusion criteria. Patients were to be 18-65 years of age, have a disease duration of 3months to 20 years, be diagnosed with RRMS according to McDonald criteria, one enhancing lesion 30 days prior to screening and an EDSS score equal to or below 5.5.
744429|NCT00937118|Inpatients requiring laparotomy for trauma with duodenal injury years 1989 - 2009|
744430|NCT00937105|From November 2009 to February 2012, 218 participants were randomized at the University Hospitals Case Medical Center Eye Institute.|Existing soft lens wearers or non contact lens wearers were recruited, no wash out period was required
744431|NCT00937040||
744432|NCT00936975||
744433|NCT00936910|Children were considered for enrollment if they had chronic intestinal insufficiency (including intestinal transplantation) and/or the presence of long term central venous access, and one or more positive blood cultures for yeast attributed to the central line|
744434|NCT00936897|Participants were randomized from 29 July 2009 through 5 November 2010|
744435|NCT00936884||
744436|NCT00936741|Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) were eligible to continue treatment in C1073-415 at the dose being administered at the end of treatment in C1073-400 (NCT00569582).|Only subjects who had completed C1073-400 (NCT00569582) were enrolled. All subjects received active drug (no placebo).
744437|NCT00936715|Participants were enrolled at study sites in the US. The first participant was screened on 06 Aug 2009. The last study visit occurred on 20 November 2015.|51 participants were screened.
744438|NCT00936702|Forty-six participants with centrally confirmed cancer of unknown primary site were enrolled between October 2009 and October 2012. The trial was closed before the target sample size of 50 was reached, because a sufficient number of confirmed responses had occurred to meet the primary endpoint.|
744439|NCT00936663|recruitment period: 10/2009 to 8/2012 Recruitment location: Transplant Clinic and Nebraska Medicine Hospital|1 subject consented, but dropped out as she was too busy to participate in the study
744440|NCT00936598|Recruitment occurred between January 2010 and May 2010 at Magee Womens Hospital and Mercy Hospital. All participants who were recruited were assigned to one arm or the other.|One participant in the placebo group was found to be ineligible after consent before starting the study (before being provided with take home materials).
744441|NCT00936585|Patients were recruited using advertisements and from patient database of Crohn's patients seen at the NIH CC.|All patients who were enrolled in the main study to receive study drug were eligible for the sub-study. There was no randomization.
744442|NCT00936481|Participants were recruited from the Vanderbilt sleep disorders clinics and from the community using emails and flyers from study start date in 2008- 2012|Once patients were enrolled in the trial and assigned to the groups, we were able to complete the protocols without having to exclude any participants.
744443|NCT00936455|Patients were assessed in July 2009. Patients were all contacted at a single time point (irrespective of time since original trial enrollment) and were asked structured questions regarding their level of function at 3 time points (6 months after original event, 12 months after original event, and current time point).|Observational study. Patient contact via telephone. Patients were all contacted at a single time point (irrespective of time since original trial enrollment) and were asked structured questions regarding their level of function at 3 time points (6 months after original event, 12 months after original event, and current time point).
744444|NCT00936377||
744445|NCT00936351||
744446|NCT00936299||
744447|NCT00936221||
744448|NCT00936208||3184 patients were enrolled but treatment was unknown in 89 patients. Therefore, 3095 patients were analysed.
744449|NCT00936117|Recruitment Period: September 30, 2009 to January 3, 2011. From January 2010 through August 2010, adult with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing induction chemotherapy or first salvage therapy were recruited at The University of Texas (UT) MD Anderson Cancer Center.|Of the 25 participants enrolled, five participants were excluded from the trial -- two were ineligible, one withdrew consent before start of treatment, another two were excluded from the study for other reasons.
744450|NCT00936065||
744451|NCT00935883||
744452|NCT00935857|Subject recruitment completed.|"Early termination at 30 patients due to clinically significant differences at midpoint of study.
~Patients in the Standard Colonoscopy group could cross-over to the Balloon Colonoscopy group after 20 minutes of procedure time but they were not included in further analysis after cross-over."
744453|NCT00935818|Recruitment was between October 2009 and April 2012. Volunteers from local communities of Rochester, MN, Minneapolis, MN and LaCrosse, WI, were recruited using newspaper classified ads, radio, TV, internet ads, print ads in magazines, word of mouth, and volunteer wait lists.|Study subjects who consented, were screened for entry criteria, and asked to return for a physical exam and medical history. If eligible and still interested, the volunteer was asked to return to the baseline visit at which time they would receive the study medication assignment.
744454|NCT00935792||
744455|NCT00935766||The study was discontinued early due to lack of funding and slow enrollment
744456|NCT00935701|Ten children with ASD (8 boys and 2 girls between the ages of 3 and 10 years) and their parents took part in a 16-week intervention. Children were recruited through autism networks and Kennedy Krieger Institute. Phase 2 was not conducted due to difficulty recruiting enough participants to successfully complete a randomized controlled trial.|All participants completed 16 treatment sessions and all parents carried out a home component of treatment during this time period.
744457|NCT00935649||
744458|NCT00935584|The study recruited 23 primary care providers from VA San Diego and its community based outpatient clinics. For each provider we enrolled approximately 6 patients from their out-patient practice. A total of 23 physicians and 126 patients were included in the final analysis.|
744459|NCT00935532||
744460|NCT00935493||154 subjects were screened, of which 135 were eligible. Of the 135 eligible, 12 withdrew consent and therefore 123 were randomized.
744461|NCT00935428|Retrospective review of patients with horse-related injuries evaluated at OHSU Hospital from 2001 - 2008|
744462|NCT00935311||
744463|NCT00935272|Date of first enrollment: July 20, 2009 Date last subject completed: June 1, 2010 180 subjects enrolled from 12 investigational centers|"Subjects with Fitzpatrick Skin Types I, II or III (lighter skin types) needed both lips to be assessed as very thin or thin to meet enrollment criteria.
~Subjects with Fitzpatrick Skin Types IV, V or VI (darker skin types) need at least one lip to be assessed as very thin or thin to meet enrollment criteria."
744464|NCT00935259||
744465|NCT00935220||
744466|NCT00935064||
744467|NCT00934947||
744468|NCT00934921||
744469|NCT00934856||Overall 152 participants were screened, of which 98 participants were enrolled (25 participants with metastatic breast cancer [MBC] and 73 participants with locally advanced breast cancer [LABC]) and included in the study.
744470|NCT00934843|All inpatient neonates (≤ 30 days of age), scheduled to undergo cardiac surgery involving cardiopulmonary bypass from the time period of July 2007 through July 2009 were eligible for this study.|
744471|NCT00934791|Two participants were enrolled in the study in Rochester, Minnesota. One participant withdrew before doing any part of the study; he was not randomized to a group.|
744472|NCT00934661||
744473|NCT00934648||
744474|NCT00934635||
744475|NCT00934622|Subjects >21 years of age, either sex, and any race. Diagnosis of cataracts in both eyes. 27-Jun-2007 to 20-May-2009|Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
744476|NCT00934596|Patients requiring elective aortic valve or aortic root surgery on the waiting list of the clinic were recruited in the study during year 2009.|All 20 consecutive patients recruited in the study fullfilled the inclusion criteria. No patient was excluded.
744477|NCT00934544|Subjects were recruited from 9 countries located in Europe: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom.|219 unique participants were randomized to either ruxolitinib or BAT. Of the 73 participants randomized to BAT, 45 were crossed over to ruxolitinib after a protocol-specified qualifying disease progression event.
744478|NCT00934440||
744479|NCT00934375||
744480|NCT00934362||two week washout period between treatment phases of this cross-over study
744481|NCT00934180||
744482|NCT00934141||
744483|NCT00934128|Recruitment period August 2009 to February 2012. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.|
744484|NCT00934102||Of the 57 subjects screened for the study, 11 did not start Period 1 due to personal reasons (7) and non-suitability (4). Period 1 established Day One measurements in order to monitor changes during Period 2.
744485|NCT00934050||All participants who enrolled in long term follow up prior to 15 Dec 2009 received ELND005 2000 mg BID; due to protocol amendment, all participants who enrolled in long term follow up after 15 Dec 2009 received ELND005 250 mg BID
744486|NCT00934024|Right-handed nicotine dependent cigarette smokers between 21 and 60 years of age were recruited via community and internet advertisements. Recruitment took place between 2009 and 2011.|All participants received open-label varenicline. Participants data was anaylzed in two groups- abstinent and non-abstinent participants.
744487|NCT00933933|All specimens collected under separate collection protocols or obtained from specimen suppliers: human immunodeficiency virus (HIV) antigen positive samples, HIV-1 antibody positive, specimens collected from individuals at risk for HIV infection in the United States (US), HIV-2 antibody positive and specimens collected from HIV-2 endemic area.|All subjects were assigned to one group. There was no pre-screening criteria for this study.
744488|NCT00933686|123 subjects were enrolled of whom 113 subjects were randomised and treated.|
744489|NCT00933608|Recruitment for this study was carried out at the NYU Center for Brain Health and Aging and Dementia Center, between May 2010 and October 2011.|
744490|NCT00933543|Recruitment from September-December 2009. Dermatology clinics, with pediatric patients|
744491|NCT00933491||
744492|NCT00933335||Participants received fludarabine in the first study phase. Upon completion of this phase, if they met the appropriate criteria, they began the first of 2 phases of radioimmunotherapy: Phase 1, dosimetric dose (DD), administered 6 weeks after Day 1 of the third fludarabine cycle; Phase 2, therapeutic dose, administered 7-14 days after the DD.
744493|NCT00933270|A total of 46 sites in the US enrolled 325 subjects into this study. The first patient was enrolled on July 30, 2009 and the last patient was enrolled on May 20, 2011. Intention-To-Treat (ITT) population included 264 subjects and Per-Protocol (PP) population included 257 subjects. In addition, 61 roll-in subjects were enrolled.|
744494|NCT00933244||
744495|NCT00933166||
744496|NCT00932893||
744497|NCT00932828||
744498|NCT00932698|Participants took part in the study at 5 investigative sites in the United States from 12 October 2009 to 23 May 2017.|60 participants with a diagnosis of relapsed and/or refractory (RR) multiple myeloma were enrolled in 1 of 7 ixazomib dose escalation groups (26 participants) and/or 1 of 4 ixazomib dose expansion groups (40 participants). 6 Participants in 2.0 mg/m^2 dose escalation cohort were also included in the expansion group: 5 in RR, 1 in VR arms.
744499|NCT00932659|Patients recruited from June 2009 to August 2010|
744500|NCT00932646||This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
744501|NCT00932620||
744502|NCT00932477||This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 products in a randomly assigned order. The subject used 1 product at a time for a duration of 1 week before switching to the next assigned product (e.g., with treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA).
744503|NCT00932451|A total of 1069 participants entered the study out of which 3 participants were withdrawn from the study before receiving study treatment because they were not eligible and were mistakenly entered into the interactive voice response system. Only 1066 participants received greater than or equal to 1 dose of crizotinib.|A total of 144 participants in study NCT00932893 were also enrolled in this study to receive treatment with crizotinib, including 143 participants randomized to the chemotherapy arm then crossed over in this study and 1 participant initially erroneously randomized in the crizotinib arm but not treated.
744506|NCT00932373|Approximately four centers in the United States were to participate in the study to enroll approximately 50-60 patients. Between 25 April 2006 and 20 May 2008, 54 patients were enrolled and 52 were treated.|Two patients enrolled but discontinued the study prior to receiving study treatment drug, thus 52 patients received at least one dose and are included in the baseline and safety analysis data.
744507|NCT00932360|Subjects (125) were screened for eligibility via telephone. 82 were excluded and 43 were consented and enrolled at the University of Iowa|43 subjects were consented and enrolled to the cross over design study. Subjects were randomized to treatment group order after providing written consent. The three treatment groups for randomization order included: active TENS, placebo TENS and no treatment TENS.
744508|NCT00932321|32 investigational study sites recruited 938 women aged 18 - 45 years of age beginning Feb '04|MITT Population defined as subset of All Treated Subjects who were evaluated for pregnancy, either positive or negative, at least once after beginning the study medication. Completed subjects - subset of MITT subjects completing at least 161 days of treatment based on returned drug or diary.
744509|NCT00932282||
744510|NCT00932165|Patients need to be administered Exemestane (Aromasin) in order to be enrolled in the surveillance.|
744511|NCT00932152||"No participants were randomized to the Best supportive care only and Best supportive care with Bevacizumab Arms due to low recruitment."
744512|NCT00932126||
744513|NCT00932113||The discrepancy between the enrollment number in the protocol section and number of participants in participant flow module is due to 3 participants screen failing and being allowed to re-screen. We counted them as enrolled upon signing of new consent and conducting re-screening visit.
744514|NCT00932035||
744515|NCT00932022||
744516|NCT00931996||
744517|NCT00931918|Participants took part in the study at 69 investigative sites in the United States from 13 October 2009 to 15 August 2015.|Participants with a diagnosis of Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma were enrolled equally in 1 of 2 treatment groups: RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] or Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] for 6, 21 day cycles.
744518|NCT00931879||
744519|NCT00931801|Recruitment was initiated on 15 APR 2010 and enrolled subjects through 31 JAN 2011. Recruitment and screening took place at 10 participating sites (9 medical clinics and 1 clinical research organization). 43 subjects were enrolled.|There were 7 participants that did not meet eligibility criteria (either due to disallowed concomitant medication use or safety labs outside of the required parameters). 2 of those 7 subjects re-screened at a later date and were confirmed eligible. 2 subjects withdrew consent after the screening visit but prior to starting the assigned treatment.
744520|NCT00931723|This multicenter study was conducted between 24 June 2009 and 22 November 2010.|The study had an up to 28-day enrollment period (including a washout period lasting 7 to 28 days) and a 6-week double-blind treatment period. Patients were randomized to receive lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day or placebo+quetiapine XR 400 to 800 mg/day.
744521|NCT00931710||
744522|NCT00931632||
744523|NCT00931528||
744524|NCT00931515|Subjects were enrolled from February 2009 to December 2010. Patients were recruited from the medical practices of the Investigators. Enrollment was stopped in December 2010 due to the slow enrollment rate. A total of 30 subjects participated in the study; the protocol was intended for 440 patients.|Two patients were enrolled in the study and received a patient identification number, but were never randomized to a treatment group and never implanted with the device. One patient decided not to participate prior to randomization. The second patient did not meet all inclusion/exclusion criteria.
744525|NCT00931489||
744526|NCT00931463|Recruitment took place from Mar-2010 till Sept-2011 at 37 sites in Argentina, Australia, Chile, UK, France, Hong Kong, India, Israel, Malaysia, Mexico, Peru, Nigeria, Singapore, South Africa, and Thailand. The sites had to be clinical facilities with a cohort of suitable patients and able to do protocol-mandated procedures.|558 participants were enrolled in the study. 14 were excluded because of unverifiable data at one site and 3 dropped out before analysis, never received study treatment
744527|NCT00931411||
744528|NCT00931385||This was a randomised, double-blind, double-dummy, placebo-controlled, 4-way crossover trial. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
744529|NCT00931359||
744530|NCT00931307||
744531|NCT00931268|First subject enrolled (screened) and treated: 11 August 2009. Last subject completed study: 2 September 2011.|
744532|NCT00931255||
744533|NCT00931242||
744534|NCT00931164||
744535|NCT00930982|Pulmonary stable participants with a proven and documented diagnosis of non-cystic fibrosis bronchiectasis (idiopathic or postpneumonic), and on a stable regimen of standard treatment, were recruited at specialized study sites.|Out of 277 participants screened, 153 failed screening (mostly due to not meeting in-/exclusion criteria or inability to produce adequate sputum samples), and 124 participants were randomized (60 to Ciprofloxacin Inhale and 64 to placebo).
744536|NCT00930969||
744537|NCT00930930|This Vanderbilt-Ingram Cancer Center, multi-site intervention study included 7 additional cancer centers. It opened to enrollment in June 2009 and ran through May 2013.|One hundred forty-seven patients enrolled in this study. Two patients were not eligible to participate.
744538|NCT00930813||
744539|NCT00930787|23 subjects recruited from 9 US sites between August 2009 and May 2010.|
744540|NCT00930774||
744541|NCT00930761|Recruitment period: 03/01/2004 to 07/31/2007. Mothers of LBW newborns (≤ 1750g) that have reached clinical stability and signed an informed consent.|Eligible mothers: 190. Excluded: 89 (26 because their neonates fullfiled one of the exclusion criteria, 18 because their newborns died before being considered in clinical stability, 11 because they did not agree to participate and 34 because they could not be accessed during the newborn hospital stay, most for receiving early hospital discharge).
744542|NCT00930722||
744543|NCT00930644|Subjects who met any of the following could be enrolled: Completed 24 weeks of treatment in Study CL0600-020; based on PI and sponsor decision, subjects who were required to stop treatment prematurely due to a non drug related AE; or successfully completed Stage I (optimization/stabilization) in Study CL0600-020 after ~86 subjects were randomized|
744544|NCT00930553|This extension study enrolled participants from previous 3 studies: CAMMS223 (NCT00050778), CAMMS323 (NCT00530348), and CAMMS324 (NCT00548405). Participants were enrolled in this study only after their Month 24 visit in CAMMS323 and CAMMS324. CAMMS223 participants were enrolled within 6 months once their site received approval of extension study.|Efficacy outcome data was analyzed only on CAMMS323 and CAMMS324 participants; safety data was analyzed on all participants, as pre-specified in protocol.
744545|NCT00930293||
744546|NCT00930176||
744547|NCT00930059||
744548|NCT00930046||
744549|NCT00929994||
744550|NCT00929981||
744551|NCT00929864|28-October-2009 to 23-November-2012. Study conducted in biologic-naive participants with Rheumatoid Arthritis (RA) who have failed on methotrexate therapy.|869 enrolled; 648 randomized; 646 randomized and treated. Reasons for not randomized: 4 pregnancy; 23 lost to follow-up; 133 administrative reasons by Sponsor; 4 no longer met study criteria; 7 other; 50 had reasons missing. Two participants randomized/not treated: no longer met study criteria. Randomization stratified by DAS28-CRP>5.1, <=5.1
744552|NCT00929838||
744553|NCT00929773|Recruitment period was July through September, 2000 at a single medical clinic.|Following enrollment and prior to group assignment, study participants underwent study qualification evaluation which included a self-report rating of current neck and/or shoulder pain level on the 0-100 VAS.
744554|NCT00929734||
744555|NCT00929708|The study has been performed at 53 centres in Bulgaria, Canada, Japan, Poland and Russian Federation. The recruitment period was between 16 June 2009 and 8 January 2010.|
744556|NCT00929695||
744557|NCT00929669|This study was initiated in 6/09 and was terminated in 6/10. 2 subjects were enrolled and 1 subject completed the 12 mos. of the study.|
744558|NCT00929656|Participants were recruited from the Malcom Randall VA Brain Rehabilitation Research Center database from 2/1/13-9/30/15|
744559|NCT00929643||Observational, epidemiological, noninterventional study.
744560|NCT00929578|Recruitment from a dermatology clinic of a tertiary care medical center. Recruitment dates from Oct 2008 to Sep 2010.|
744561|NCT00929526|No vaccines were administered in this extension study. The mean duration of this study was aproximately 12 months for each subjects (from Month 0 up to Month 12). This study began 36 months after the first vaccination in study NCT00316693.|Subjects were randomised in the primary vaccination study NCT00316693 to receive the Cervarix vaccine or the Aimmugen vaccine and were aged 20 - 25 years at the time of first vaccination. Only subjects showing willingness to participate in this long term follow-up study and who had signed the informed consent form entered this study.
744562|NCT00929500||A total of 28 subjects were consented. Of those, 16 were determined ineligible to participate. 12 subjects were randomized (8 to intervention group and 4 to control group). At the end of the trial, only 4 intervention and 4 sontrol subjects completed the study.
744563|NCT00929474||
744564|NCT00929383|"Patients eligible were diagnosed with symptomatic Intracranial Atheroslcerotic disease and scheduled to be treated with a Wingspan Stent in 6 centers in France and 9 centers in Germany.
~The first patient was enrolled on 11 March 2009 and last patient on 30 April 2012."|This was an open label registry (observational study). All patients scheduled for treatment with a Wingspan Stent meeting inclusion/exclusion criteria were eligible for participation.
744565|NCT00929357|A total of 160 participants were screened and 156 entered this non-randomized retrospective evaluation of conventional systemic therapies and biologics in participants with rheumatoid arthritis in routine practice.|Participants had been treated according to authorized dosages for disease-modifying anti-rheumatic drug (DMARDs) and biologics in Germany. No investigational product had been provided.
744566|NCT00929344||
744567|NCT00929331||
744568|NCT00929305|Recruitment period was June-July, 2001. Locations were 3 private practice test sites: 2 in California and one in Virginia.|14 enrolled participants were subsequently excluded for taking study excluded medications, for having a self-reported pre-treatment pain Visual Analog Score (VAS) of less than 50 and for having a herniated disc injury.
744569|NCT00929240||
744570|NCT00929201||
744571|NCT00929162|132 patients with advanced ovarian cancer sensitive to platinum-based chemotherapy were recruited between 26th June 2009 and 1st June 2011.|12 of the 132 enrolled patients were not randomised to treatment groups as they failed screening
744572|NCT00929110|A total of 1993 patients were screened from 180 participating sites, of whom 1066 were randomized to 1 of the 3 treatment groups in a 2:1:1 ratio glycopyrronium bromide:placebo:tiotropium.|
744573|NCT00929071||
744574|NCT00928954||
744575|NCT00928889||
744576|NCT00928772||
744577|NCT00928746||
744578|NCT00928720||
744579|NCT00928707||
744580|NCT00928694||
744581|NCT00928668|This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. The duration of each treatment period was 1 day with a 14 day washout period between treatments.|One patient was randomized, but the trial was put on hold so that the patient had to be discontinued and re-randomized. This causes a discrepancy between the 32 patients enrolled and the 31 patients reported for the participant flow.
744582|NCT00928642|"Three subjects were enrolled at Brooke Army Medical Center. Five subjects were enrolled at Madigan Army Medical Center.
~Seven of eght subjects are deceased as of 4/4/2013."|
744583|NCT00928512||A total of 16 patients discontinued prior to Week 16.At Week 20, all patients on secukinumab 25-150 mg who were responders continued on their randomized dose regimens. Non-responders in the 25 mg and 75 mg groups were up-titrated to 150 mg and non-responders in the 150 mg group were up-titrated to 300 mg.
744584|NCT00928486||
744585|NCT00928434||Of the total 409 patients enrolled, six patients were not dosed either due to randomisation error, failing eligibility criteria or consent withdrawal after being randomised.
744586|NCT00928421||
744587|NCT00928408||
744588|NCT00928395|Subjects were recruited by investigator sites.|
744763|NCT00919633|Enrollment 09-Jun-2009, final subject complete 19-Jun-2012.|210 screened, 116 randomized, 106 received at least 1 dose of study drug.
744764|NCT00919191||
744765|NCT00919126||
744766|NCT00919113||
744589|NCT00928304|The study was conducted at two sites in the US.|A total of 130 subjects were screened. 21 subjects were considered as screen failures and were not enrolled into the study. 9 subjects did not meet the inclusion/exclusion criteria. 10 subjects withdrew their consent. 1 subject was lost to follow-up and 1 subjected exceeded the weight limit for the camera.
744590|NCT00928252||
744591|NCT00928226||
744592|NCT00928200||
744593|NCT00928187|Recruitment in three study sites (Yaoundé, Dakar and Bobo Dioulasso) in HIV day care clinics from January 2010 to September 2012.|584 patients assessed for eligibility, 130 excluded primary (13.9%) because control viral load decreased below 1000 copies/mL after adherence support.
744594|NCT00928174||
744595|NCT00928083||
744596|NCT00928070||
744597|NCT00928057|Subjects were recruited at four independent research centers/diabetes clinics from June 2009 - October 2009|A total of 205 subjects were screened at four sites. Of those, 32 subjects did not satisfy eligibility criteria or withdrew consent prior to using the test products, and the remaining 173 subjects were enrolled and randomized.
744598|NCT00928018||
744599|NCT00927992||
744600|NCT00927953|Participants were recruited over two West Nile virus seasons in 2009 and 2010 at 16 (2009) to 19 (2010) sites in the United States. One participant enrolled in 2009; 12 in 2010.|
744601|NCT00927940|The first patient and the last patient were enrolled on Mar. 23, 2009 and Oct. 30, 2009 respectively. Total 100 patients were enrolled in this study from 14 sites.|
744602|NCT00927927|The trial was conducted at one site in Germany.|A total of 65 subjects were randomised, but only 64 subjects were exposed to trial product. One subject withdrew consent after being randomised but before receiving any trial product.
744603|NCT00927901||
744604|NCT00927888|Stanford medical center|Having unilateral FESS
744605|NCT00927862|Those >= 18 years and being initiated on warfarin therapy with a target international normalized prothrombin time ratio (INR) of 2-3 or 2.5 -3.5 among participating hospitals and outpatient clinics were invited to participate and sign informed consent.|If after enrollment, pt was found to be not appropriate for warfarin or pharmacogenetic (PG)-guided dosing or physician preference not to have pt participate they were not randomized. Description below and baseline characteristics report combined PG arms because of similarities but outcome measures report combined and individual PG results.
744606|NCT00927849|completed , mansoura university hospital|
744607|NCT00927823||
744608|NCT00927784|80 patients with end-stage CHF and clinical indication for implantation with an FDA-approved LVAD as a bridge-to-transplant were to be enrolled. 40 patients in the low dose cohort(25M)/40 patients in the high dose cohort(75M). Trial enrollment was permanently suspended upon 10 patients enrolled in the low dose cohort due to a change in NIH funding.|
744609|NCT00927758||Actual screened patients was 105. However, 22 eligible patients were randomized.
744610|NCT00927589||
744611|NCT00927576||
744612|NCT00927563|Subjects were recruited via media advertisement from January 2010 through February 2012 at the University of Minnesota Department of Psychiatry.|Subjects could not be using concomitant use of psychotropic medications with possible effects on PG symptoms (i.e. antidepressants, opioid antagonists)(due to possible interference of results) or have had previous treatment with tolcapone.
744613|NCT00927485|The study was conducted from September 2011 to November 2016 at the Johns Hopkins Hospital and the University of Puerto Rico Medical Sciences Campus. Participants were identified and recruited from the Johns Hopkins Polyposis Registry or from the University of Puerto Rico Familial Colorectal Cancer Registry.|Absence of effective birth control; pregnancy; WBC < 3500/ml; platelet < 100,000/ml, BUN > 25 mg/dl, Creat > 1.5 mg/dl; malignancy; unwillingness to discontinue NSAIDs; active reflux; hx of peptic ulcer; active bacterial infection; use of warfarin or antiplatelets; allergy to curcumin. 3 month washout period for individuals taking NSAIDs, curcumin, turmeric, aspirin, calcium, vitamin D, green tea or polyphenol E
744614|NCT00927472|Subjects were recruited at 2 dermatology clinical practices|
744615|NCT00927394||
744616|NCT00927368||
744617|NCT00927355|3/09 to 4/11, diabetes clinic and grady hospital|one participant failed to disclose that she was already on pioglitazone and was excluded
744618|NCT00927264|Caregivers of children were recruited from 16 Baltimore City Head Start programs from April 2009 to August 2012 with final data collection ending August 2013.|Caregivers had to complete a baseline assessment prior to randomization and reported information for themselves and the targeted child due to the young age of the child. 350 caregivers were recruited but only 330 were randomized because 20 did not complete the baseline assessment.
744619|NCT00927251|The trial began with the first subject enrollment on July 1, 2009 and subsequent first implant of the Model 4296 LV lead on July 2, 2009. A total of 90 subjects were enrolled in the study of which 82 were successfully implanted with a Model 4296 LV lead. Last enrollment took place on December 16, 2009.|
744620|NCT00927186||This was a Phase 4, multicenter, randomized, stratified, double-blind, active comparator-controlled study with the primary endpoint at 6 months. Following the bone biopsy visit at 6 months, the study became open label for an additional 6 months. All participants who complete 12 months of treatment are eligible for an additional 12-month extension.
744621|NCT00927160|This is an observational study which enrolled patients hospitalized from November 2008 to August 2011 at the Mount Sinai Hospital from the MACE Service or general medical service.|No group assignment as this is observational.
744622|NCT00927095||
744623|NCT00927082|The study was conducted from 10 April 2009 to 05 November 2014. A total of 383 participants were recruited from 31 centers across 9 countries (Australia, New Zealand, China, Taiwan, Singapore, Korea, Thailand, Brazil, and Russia).|
744624|NCT00927069||
744625|NCT00926952|Recruitment period lasted from July 30, 2009 to July 14, 2010. Type of location was a medical research clinic.|
744626|NCT00926887|The recruitment period was from 9/30/05 - 6/28/07 at private practice test site locations.|There were no significant events or approaches for the study following participant enrollment and prior to group assignment. All enrolled participants proceeded to group assignment.
744767|NCT00919100||
744768|NCT00919061||
744769|NCT00919035||
744627|NCT00926848|158 couples were assessed for eligibility; 87 couples did not meet inclusion criteria. Of the 72 eligible, 37 declined to participate. Of the 34 couples who consented, 17 couples (17 patients and 17 partners) were randomly allocated to the PaTH group and 17 couples (17 patients and 17 partners) to the usual care group = 68 individual participants.|One patient in the PaTH intervention group did not tolerate the baseline (T1) exercise treadmill test due to orthopedic problems. Thus, this couple was ineligible to continue in the study.
744628|NCT00926796|Participants were recruited in outpatient STD clinics located in 5 cities across the United States.|Since Gonorrhea lab results were not available at randomization, participants who were found to be negative for Gonorrhea were withdrawn after randomization as they did not meet one of the eligibility criteria.
744629|NCT00926783|The first subject of the study was consented on August 17, 2009. The final follow-up was performed on November 14, 2011. The total study duration was approximately 27 months. A total of 86 subjects were enrolled from 7 participating sites; 2 sites in the United States (US), 4 sites in Canada, and 1 site in Australia.|Among the 86 consented subjects, two were excluded prior to randomization; one was excluded due to thrombus found on pre-procedure echo. Hence only 83 subjects were randomized to the two treatment arms and underwent radio-frequency ablation
744630|NCT00926588|Participants were recruited from June 2010 through May 2012. Patients and physicians in 5 primary care clinics in the Roudebush Veterans Administration Medical Center in Indianapolis participated.|
744631|NCT00926575||
744632|NCT00926536|Study was open from 01/13/2009 thru 10/13/2010. During this period, subjects with HCC who were scheduled to undergo TACE were approached for permission to participate in the study.|
744633|NCT00926497|Between June 1, 2005 and December 31, 2006 all term and near-term infants with a gestational age more than 34 weeks with suspected early-onset sepsis admitted to the Children's Hospital of Lucerne|
744634|NCT00926393|A 7-day, inpatient, multicenter, double-blind, double-dummy, randomized, parallel group, Phase IV study was done to compare the tolerability of quetiapine IR with quetiapine XR during initial dose escalation in patients with bipolar depression. In total 139 patients were randomized in 15 centers in the USA between June and August 2009.|Patients must have DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed, and outpatient status at enrollment . Patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.
744635|NCT00926380||
744636|NCT00926367|Clinical research center.|Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.
744637|NCT00926328|Performed by the Research Department School of Dentistry UPR|
744638|NCT00926289||894 patients were entered (randomised) into the study; however, of these, 6 were not treated. Therefore 888 patients actually entered into treatment.
744639|NCT00926263||Study participants were planned to be assigned to 1 of 3 sequential dosing cohorts: CP-751,871 at 10 mg/kg; at 20 mg/kg; 2 doses of 20 mg/kg on consecutive days. Dosing was via intravenous (IV) administration. The third dosing cohort (2 doses of 20 mg/kg on consecutive days) did not enroll participants due to early termination of the study.
744640|NCT00926237|A total of 58 participants were enrolled. Recruitment used a waitlist of subjects who already expressed interest in tinnitus studies and from advertisement.|Of the 58 subjects enrolled, only 39 were assigned to study groups. Two subjects who initially failed screening were re-enrolled via a waiver before assignment. Ten had participated in an early version of the protocol that was not comparable. Seven subjects dropped out after baseline. So 2+10+7= the 19 participants who were enrolled but not started in the participant flow.
744641|NCT00926211|Subjects were recruited from June 19, 2009 to September 23, 2010 at hair restoration clinics.|Once enrolled, subjects were scheduled for the treatment procedure. Subjects were randomized at the time of the treatment procedure.
744642|NCT00926185||The study was conducted in a Controlled Adverse Environment (CAE).
744643|NCT00926029|At the clinical site|
744644|NCT00926003|159 school-age clinically stable children receiving monthly out-patient care at the Walter Reed Children's Clinic at the Kayunga District Hospital Kayunga town, Uganda.|Of 190 total available children at the study site, 159 were enrolled into the present clinical trial. 13 were ineligible due to profound neurocognitive disability or very poor health; 7 could not be reached; 7 lived outside of the study catchment area, and 4 declined to participate.
744645|NCT00925990||
744646|NCT00925938|Premenopausal women requiring cervical priming prior to an in-office hysterectomy procedure were recruited at 5 sites in the US|"Part 1 of the study included only women who had at least one vaginal delivery. There was no restriction on vaginal delivery status in Part 2 of the study.
~Part 1 participants were included in the MVPI 400 mcg cohort, MVPI 800 mcg cohort and the Placebo cohort.
~Part 2 participants were included in the MVPI 800 mcg cohort and the Placebo cohort."
744647|NCT00925899||72 patients were randomised in the study. 50 patients completed the first part of the stud, only 44 patients were complete compliers (having taking their melatonin and placebo for at least five days each week and having answered the questionnaires at all times). The primary analysis is of the 44 complete compliers.
744648|NCT00925782|The study was conducted at a single study center (University of Kansas Medical Center -two facilities) in the United States under the direction of the investigator, Omar S. Aljitawi, M.D.|No patients that were enrolled in the study were excluded from the trial prior to assignment to groups.
744649|NCT00925769||Thirty two (32) participants were included however, 2 participants discontinued before reaching the end of the evaluation period of 3 cycles of the complete study regimen (of all 3 drugs) at the recommended dose due to progressive disease.
744650|NCT00925756||
744651|NCT00925704||Patients were randomly assigned to 1 of 6 treatment sequences which consisted of 3 treatment periods separated by a washout of 7 days. In each of the treatment periods subjects received lanthanum carbonate + calcitriol, sevelamer carbonate + calcitriol or calcitriol alone.
744770|NCT00918957||Although 32 patients were randomized to the TIP group and 30 to the Placebo group, the ITT population included 2 patients allocated to the TIP group but received placebo due to Investigator error during the drug dispensation process. The safety population contained 30 patients who were treated with TIP and 32 patients who were treated with placebo.
744652|NCT00925600|"This study was conducted at 125 centers in 18 countries: Australia, Bulgaria, Canada, the Czech Republic, France, Greece, Hungary, India, Latvia, Mexico, New Zealand, Poland, Russia, Slovakia, Slovenia, South Africa, Ukraine, and the United States.
~The first participant enrolled on 30 November 2009 and the last participant enrolled on 04 May 2015."|Participants were randomly assigned to receive denosumab or placebo in a 1:1 allocation ratio. Randomization was stratified on the basis of screening Lens Opacities Classification System (LOCS) III status (< 3.0 at all sites versus ≥ 3.0 at any site); age group (< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).
744653|NCT00925587||
744654|NCT00925548||
744655|NCT00925522|Patients with atrial flutter are evaluated by ablation doctor in the EP clinic and assessed for possibility of meeting other inclusion criteria.|This is a non-randomized study.
744656|NCT00925353|Recruitment fliers were posted at St. Luke's health System's oncology, screening mammography, internal medicine, and family health clinics, in-patient hospitals, and Boise State University.|56 potential subjects responded to the fliers during the enrollment period. 31 did not meet study criteria. 13 enrolled. 3 did not meet the preliminary EKG or laboratory criteria and were withdrawn prior to gel application. 10 subjects completed the trial.
744657|NCT00925301||During Stage 1 (0-6 Months), all participants were randomized to either Migalastat or Placebo. After Stage 1, all participants progressed to Stage 2 where they received open-label migalastat for 6 months (>6-12 Months). After Stage 2, participants were eligible to enter the optional, 12-month, open-label extension (OLE) (>12-24 Months).
744658|NCT00925288|FSWs 18-26 years of age were recruited in person between August 28, 2009 and March 3, 2010 from 49 different sex locales in Lima, Peru by trained medical staff and 8 health promoters. If they fulfilled inclusion criteria, women were asked to report to the study clinic for completion of surveys, vaccination, Pap smears, and counseling.|Some eligible participants provided a false phone number, did not show up for their study appointment, refused to use birth control when receiving vaccine doses, and reported not having time to participate in the study. After the survey and Pap smear, vaccination was the final step in study enrollment.
744659|NCT00925132|Subjects were recruited between December 2009 through June 2015. The study population was accessed via the Principal Investigator's medical clinic at Holden Comprehensive Cancer Center.|Following consent, all subjects undergo screening procedures to verify eligibility for participation in the study. Screening included physical exam, blood and urine tests to check general health, blood test for fetal hemoglobin, blood test for pregnancy (only for women of childbearing age), ECG and Echo, CT and FDG-PET, and tumor measurements
744660|NCT00925119||
744661|NCT00925054||
744662|NCT00925015||
744663|NCT00924950|Recruitment took place at the University of California at San Francisco (UCSF) Psoriasis and Skin Treatment Center.|Patients were assessed for psoriasis severity as well as washout from other concomitant medications
744664|NCT00924898|Individuals with acute HIV (AHI) detected via a statewide AHI screening program in publicly funded sites and primary care sites are reported to the NC Department of Health and Human Services (DHHS). DHHS staff immediately refer acute cases to HIV care. From Jan 2005 and Dec 2011, all AHI cases referred to UNC and Duke were offered enrollment.|This was a single-arm, open-label study of emtricitabine/tenofovir/efavirenz started at enrollment. All participants received the same study treatment. Study treatment was not delayed for baseline resistance testing. Participants with transmitted baseline resistance to any drug in the regimen were followed on study on an alternative regimen.
744665|NCT00924885||
744666|NCT00924833|Participants were recruited period between May 2006 and June 2006 at the Cardiology Division, S. Luca Hospital, Istituto Auxologico Italiano, Milan. Italy.|35 subjects were screened. Out of theese 7 subjects were excluded because they did not meet the inclusion/exclusion criteria. 27 subjects were randomized to the three treatment groups.
744667|NCT00924820|Recruitment Period: June 15, 2009 to February 28, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.|
744668|NCT00924807||
744669|NCT00924781|Participants were recruited from 46 centers (9 centers in Bulgaria, 27 in United States, 3 in Romania, 4 in Italy, and 3 in Poland).|At randomization, participants received either MK2578 or matching placebo on Day 1 and crossed over to the alternate treatment at the next dialysis treatment on Day 3.
744670|NCT00924729||
744671|NCT00924651||
744672|NCT00924638|A total of 447 subjects were enrolled in 55 study centers from 14 countries in North America and Europe, during the recruitment period of June 2009 to April 2012.|A total of 6 enrolled subjects were exited from the study prior to randomization due to: Eligibility criteria not met (n=4), and Subject withdrew consent (n=2).
744673|NCT00924612|Sixteen subjects (8 at each study center) were enrolled. A total of 72 subjects were screened (16 subjects at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and 56 subjects were screened at Anapharm, beginning on April 3, 2009.|
744674|NCT00924560|Healthy, postmenarcheal, adolescent females who were either willing to be randomly assigned to 1 of 2 open-label oral contraceptive (OC) treatment regimens or who were not seeking current treatment with hormonal contraceptives and agreed not to use hormonal contraception throughout the 12-month duration of the study (control group).|"Eligible participants initiating treatment with OCs were randomly assigned to one of the two treatment groups; eligible participants not initiating treatment with hormonal contraceptives were assigned to the untreated control group.
~Twenty-six participants at one clinic were excluded from all analyses as the site was closed due to audit findings."
744675|NCT00924508|Eligible eczema patients from one U.S. clinical site were invited to participate|Consent was initially obtained from 23 participants, but 3 participants withdrew consent
744676|NCT00924482|Cardiac output measurements were made in adult patients undergoing cardiac surgery at the San Francisco VA Medical Center. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.|Design of the ECOM system and algorithm as well as safety testing were done using an animal model. The initial participants were used to finalize the system and model of the relationship between true and impedance-derived measurement of cardiac output. The final algorithm and electronics were tested in the last 101 enrolled participants.
744677|NCT00924469||
749181|NCT00700401|A total of 262 participants were enrolled from 13 centers in Brazil. This study was conducted between 26 November 2008 and 19 November 2010.|
744678|NCT00924443|Participants were entered into the study between 14 Jun 2004 and 14 Nov 2005. Participants were recruited from 14 of a total of 17 registered centres located in the United Kingdom (UK), Ireland and Italy. Relapse and survival data follow-up cut-off was extended to 23 May 2008.|A total of 69 participants were screened and enrolled. A total of 66 participants received study drug and are included in the reported results.
744679|NCT00924404||
744680|NCT00924352|The Phase I portion of this study was conducted at 4 oncology clinics located in the United States. The Phase II portion of the study was conducted at the 4 Phase I sites, plus 10 additional oncology clinics located in the United States. Enrollment started in July 2009 and was completed in June 2012.|Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
744681|NCT00924326||Three patients treated in arm 1 (1x10e9-1x10e10 cells/kg + high dose IL2) had disease progression and were then retreated in Period 2 (1x10e9-1x10e10 cells/kg + high dose IL2).
744682|NCT00924313||
744683|NCT00924287|One participant was accrued to this study.|
744684|NCT00924209||
744685|NCT00924170||
744686|NCT00924118||
744687|NCT00924066||
744688|NCT00924053|The first subject was enrolled on 12 Jun 2009; the last subject was completed on 28 Jul 2009. Subjects participated at a CRO in San Antonio, TX.|For 3 weeks after enrollment and prior to assignment to treatment and receiving drug, subjects were screened (informed consent, medical history, vital signs, electrocardiogram, laboratory test results, and screening for drugs of abuse and alcohol use) and began a 14 day washout period (counseling, review of medications and adverse events).
744689|NCT00924040|The study was designed to enroll 21 patients with an expected accrual of 2-3 patients every 2-3 months. Accrual ceiling was 25 patients.|
744690|NCT00924001|One participant was enrolled to this study.|
744691|NCT00923975||
744692|NCT00923949|1 participant was accrued to this study.|
744693|NCT00923936||
744694|NCT00923910||
744695|NCT00923845||
744696|NCT00923598||
744697|NCT00923481||
744698|NCT00923364||
744699|NCT00923351||Forty-four patients were enrolled. Twelve patients were not treated in Arm A or B because they did not get far enough in the study to be designated for an Arm.
744700|NCT00923273||DL5 wasn't tolerated. We expanded DL4, had 1 DLT of gr. 3 infection that was possibly related to study drugs or his cancer and declining health. The last subject on DL4 had gr. 4 neutropenia that lasted <7days. We believe this wasn't significant and a lack of foresight to add length of neutropenia as DLT. IRB allowed DL4 with DLT stopping rule.
744701|NCT00923260|Patients from the obesity clinic were recruited from November 2005 to October 2006|
744702|NCT00923247||No participants were enrolled in the phase IIB cohort.
744703|NCT00923195||
744704|NCT00923156||Patient enrolled to 4 week open label run-in phase (period 1) to up-titrate ramipril dose. 123 patients were randomized on Day 1 of Period 2 in a double-blind fashion to one of the three (1:1:1) treatment arms. The double-blind period was for 12 weeks.
744705|NCT00923130||
744706|NCT00923117||
744707|NCT00923091|This study was conduct in Europe from 27 May 2009 to 12 January 2011|Study has randomised, double-blind, placebo-controlled parallel-group portion (Periods I-II) followed by transition phase (Periods III-V) wherein combination titration steps were evaluated in subjects not achieving blood pressure goals. The transition required that all be entered into Period 3 on olm/aml/hctz 20/5/12.5 to ensure a common baseline.
744708|NCT00923078||Healthy comparison subjects completed a single assessment at baseline and did not receive intervention or follow-up testing.
744709|NCT00922987||A total of 286 participants were assigned to treatment. At 1 of study sites, lack of archival of study files, source documentation, missing informed consent forms and large data discrepancies led to exclusion of all data from this site (N=5), as data could not be verified. Removal of these 5 participants did not change interpretation of results.
744710|NCT00922974||
744711|NCT00922935||
744712|NCT00922883||44 patients were consented, but 1 patient was removed before treatment with the investigational agent was initiated because an additional review of baseline bone marrow revealed that the patient was not eligible, because the patient had changes in the bone marrow inconsistent with a diagnosis of aplastic anemia.
744713|NCT00922779|A total of 7799 participants were screened, of which 6661 participants were included in the study.|
744714|NCT00922766||A total of 618 participants were screened, of which 617 participant were assigned to study treatment and 1 participant was excluded based on investigator's discretion.
744715|NCT00922701|From June, 2004, to November, 2004. Medical Clinic|One-week run-in
744716|NCT00922636||"Treatment phase: Participants were randomized to:
~1 of 3 fixed-dose LY2216684 treatment arms, placebo, or extended-release methylphenidate (stimulant-naive stratum)
~1 of 3 fixed-dose LY2216684 treatment arms or placebo only (stimulant-prior stratum) Optional Taper phase: Participants received study drug (at reduced dose) or placebo for 2 weeks"
744717|NCT00922623||
744718|NCT00922480||
744719|NCT00922441||
744720|NCT00922428|The observational study was carried out by medically-trained doctors who generally treated patients with rheumatic disorders. By choosing a range of different medical specialties - predominantly orthopaedics, rheumatology, general medicine, sports medicine and family doctors - it was ensured that a broad spectrum of patients was recruited.|The observational study was carried out between January 2008 and the end of May 2008 by 280 therapists. The non-interventional character of an observational study meant that no exact timeframe for the treatment of patients was specified.
744721|NCT00922272||The study consisted of a 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20 to 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily. They were then randomized into the Double-Blind Phase receiving either their optimal dose of SPD489 or placebo once-daily for 4 weeks.
744722|NCT00922233||
744723|NCT00922207||
744724|NCT00922194|February 2006 to December 2008; Sircar Diabetes Clinic|
744725|NCT00922116||
744726|NCT00921947||
749182|NCT00700375||
744727|NCT00921934|The patients were recruited from general practioners between April 2009 and December 2010.|Between April 2009 and December 2010 16 general practitioners recorded data of 68 participants with symptomatic herpes zoster (one patient with viral infection) who received vitamin C intravenously (Pascorbin® 7.5 g/50 ml) for approximately 2 weeks in addition to standard treatment.
744728|NCT00921895|The recruitment period was June 2009 - May 2011. The study was performed at private ophthalmology practices and academic centers.|
744729|NCT00921843||
744730|NCT00921687||
744731|NCT00921557|Fifty-two (52) study participants were recruited between November 5, 2009 and March 27, 2014, at 10 study sites: 8 in the United States and 2 in Brazil.|Children and adolescents were randomly assigned to 3 treatment sequence groups. Two participants were enrolled, but because their baseline lumbar spine bone mineral density z-score was greater than -1.5 at their baseline visit, they never started study treatment and were taken off the study.
744732|NCT00921518||
744733|NCT00921310|The study opened to participant enrollment on 09/28/2009 and closed to participant enrollment on 12/20/2011.|
744734|NCT00921115||
744735|NCT00921024||Two subjects, one in each arm, did not receive treatment.
744736|NCT00920907|Study started August 3, 2009, ended October 31, 2012; Induction Phase (Weeks 1, 4, 7, 10), Maintenance Phase (participants without immune-related progressive disease (irPD) received ipilimumab every 12 weeks until disease progression, toxicity, pregnancy, death, withdrew consent, lost to follow up); Patients followed for 10 weeks post last dose.|99 participants enrolled; 75 participants randomized and treated. 24 participants not treated due to violations of inclusion or exclusion criteria.
744737|NCT00920855||Fifty-one patients were screened and forty from 10 U.S. centers were enrolled. Reasons for not enrolling were failed to meet inclusion and/or exclusion criteria (10) and an adverse event (1).
744738|NCT00920829|358 Subjects were recruited via media advertisements and clinical referrals and 355 provided a blood sample for A118G genotyping.|A118G genotyping was performed for 355 of these, 259 were A/A (Asn40) allele and 96 were any G (asp). Of the 259 Asn40 subjects, 89 were selected to participate 5 met exclusion criteria and 7 were lost or declined. Of the 96 Asp subjects, 9 met exclusion; 12 were lost or declined.
744739|NCT00920816|First-line participants included all treatment-naive participants with metastatic renal cell cancer (mRCC) from global and second-line participants included all previously-treated Asian participants with mRCC.|
744740|NCT00920790|Participants were enrolled from 1 June 2009 through 9 November 2010|
744741|NCT00920699||
744742|NCT00920686|First Patient Screened: 17 June 2009 Last Patient: 17 December 2009|Subjects meeting eligibility requirements at Screening were randomized at Visit 1 to NXN-188 600 mg, sumatriptan 100 mg or placebo in a 1:1:1 ratio. Randomized subjects were instructed to take study drug when they experienced a mild to moderate migraine headache with aura. Sunbjects not meeting the dosing criteria were discontinued from the study.
744743|NCT00920647|"The first patient enrolled on 18 November 2009.
~Patients were assigned randomly to active dose or no treatment. A total of 16 patients were randomized, 4 to each dose group and the no treatment arm."|
744744|NCT00920621|VDAART was a randomized, double-blind, placebo-controlled trial. Enrollment began October 2009 and completed follow-up January 2015 in 3 medical centers in the United Stated. 881 pregnant women age 18-39 at high risk for having children with asthma were randomized at 10-18 weeks gestation. 5 did not meet inclusion criteria and were removed.|
744745|NCT00920556|A total of 24 participants with Multiple Myeloma were enrolled in the study. The study was conducted at four centers in United Kingdom and 1 center in Denmark, and was terminated early.|
744746|NCT00920439|Out of 26 subjects enrolled in the study, one did not receive any vaccination.|
744747|NCT00920426|This study was conducted at 4 centers in the United States from 09 June 2009 to 13 August 2009.|A total of 9 participants were randomized in the current study to receive 5 milligrams (mg) of GSK1265744 or Placebo. A total of 8 participants were previously randomized in study ITZ111451 part C HIV cohort, NCT00659191 to receive 30 mg of GSK1265744 once daily.
744748|NCT00920374||
744749|NCT00920309||
744750|NCT00920231||
744751|NCT00920218|Serological evidence of prior Varicella-Zoster Virus infection for those born in 1980 or later and for those born outside the US before 1980 in a tropical or sub-tropical region was required. All subjects were to have undergone autologous hematopoietic stem cell transplantation (HCT) within the past 50-70 days; and had no additional HCTs planned.|Out of the 121 subjects enrolled into this study, 1 subject was eliminated due to not receiving study vaccination and hence only 120 subjects started.
744752|NCT00920140||This is a Phase I/II study. Phase I is a dose escalation phase in participants with relapsed or refractory leukaemias to identify the recommended dose of GSK1120212 for Phase II. Phase II further evaluates the safety and efficacy of the recommended dose.
744753|NCT00920075|Participants who have completed our earlier phase-1 and II study on alendronate in juvenile osteoporosis will be invited in this post study to evaluate the bone density/ fractures after discontinuation of therapy. Interested participants will be scheduled for a one time clinic visit. No treatment is involved.|Participants should have completed our earlier phase I or II study on alendronate in juvenile osteoporosis. Participants will be recruited by invitation only.
744754|NCT00920023||
744755|NCT00919932||
744756|NCT00919893|Outpatients at urologic clinics. Start date: December 1999. Stop date: January 2004.|
744757|NCT00919867||Study consists of 3 treatment periods performed in 6 dosing sequences: SPD503 (extended-release guanfacine HCl) single 4 mg dose, Vyvanse (lisdexamfatamine dimesylate ) single 50 mg dose, and SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered. There is a washout period between each treatment period.
744758|NCT00919854|This study was conducted in 5 countries: Argentina, Brazil, India, Kenya, and South Africa.|27 participants were recruited and treated in this study; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participants), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.
744759|NCT00919802|Protocol Open to Accrual: June 2010, Primary Completion Date: September 2015 and Study Completion Date: September 2015. Recruitment location: University of Alabama at Birmingham.|The major goal of this project was to evaluate the efficacy of intranasal oxytocin in relieving bladder pain in a cohort of patients with interstitial cystitis.
744773|NCT00918866|participants were recruited from hospitals and clinics in the USA between July 2009 and December 2009|There were no randomization procedures or other pre-assignment requirements in this study.
744774|NCT00918749|Screening began 27 May 2009|
744775|NCT00918736|Fifty patients fulfilled the inclusion criteria and consented to take part in this study.|One patient withdrew his consent and one had a fear of injection prior to receiving the first injection. Two patients withdrew from the study before the third injection (one because of an unrelated intercurrent illness and one moving to another city).
744776|NCT00918723||
744777|NCT00918684|Participant Flow of the Overall Study|116 participants were consented and enrolled. 10 of these subjects did not participate in the washout/placebo phase.
744778|NCT00918671|Inclusion during the period between January 2008 and May 2010|Invited to visit a neurologist, interviewed by telephone, give response by letter, or had headache data available in their hospital records
744779|NCT00918645||
744780|NCT00918580||
744781|NCT00918567|Subjects were recruited from schools, pediatric offices and the local community through radio and print advertisement. Subjects were recruited between Jan of 2007 and the spring of 2008.|uneven number because set of twins randomized as one unit at parental request
744782|NCT00918463||
744783|NCT00918385|Accrual open from January 2009 to July 2011 in these institutions: Dana Farber Cancer Institute, Duke Cancer Institute, MD Anderson Cancer Center, Oregon Health & Science Univ, U of CA at San Francisco, U of Washington.|64 consented, 7 screen failures. Of the 57 who began enrollment, 2 not assigned to treatment (withdrew consent, clinically unstable), 22 QC technical failures (received dasatinib off study) and 33 assigned per protocol (15 high AR, 18 low AR), 2 progressed before treatment. 14 high AR and 17 low AR began treatment and are included in the analysis.
744784|NCT00918346|"At 2 centers in Germany, 1 center in Finland:
~14 September 2005 first patient screened 08 November 2005 first patient randomized 05 April 2006 last patient completed"|A total of 45 patients screened and 43 patients randomized. 2 screening failure patients: 1 withdrawn consent and 1 too low IOP (inclusion criterion 4).
744785|NCT00918333||
744786|NCT00918281|70 Subjects started and enrolled in this study. 41 Subjects completed this study and 29 did not complete this study.|Due to the number of subjects that did not complete this study, additional subjects were enrolled bring to total enrolment to 70 subjects.
744787|NCT00918255||
744788|NCT00918229||
744789|NCT00918203||Participants who had evidence of progressive disease (PD), died or crossover to Olaratumab were considered to have completed the study.
744790|NCT00918138||219 participants were enrolled; 126 entered single-blind dietary/exercise/metformin extended release (XR) lead-in period (either 4- or 8-weeks long, based on pre-enrollment metformin dose). 33 participants did not enter treatment period (22 no longer met study criteria, 7 withdrew consent, 2 lost to follow-up, 1 adverse event, and 1 other reason).
744791|NCT00918125|Recruitment occurred at 3 centers: Duke University Medical Center, Alamance Regional Hospital; and Southeast Regional Medical Center in North Carolina. Patients were enrolled during 2011.|
744792|NCT00917865|Recruitment period: 5/2008-3/2011. Subjects were referred from physician's offices|
744793|NCT00917852||
744794|NCT00917735|August 2009 through April 2013|Prior to randomization, participants went through a screening clinic visit in which anthropometric characteristics and blood pressure were measured. In addition, blood was drawn to assess catechol-O-methyltransferase (COMT) genotype, hepatic function, and serological markers of hepatitis B and C virus.
744795|NCT00917644||
744796|NCT00917579|Healthy volunteers were recruited from one research center between July 2008 and September 2008.|
744797|NCT00917553||
744798|NCT00917501||
744799|NCT00917462||
744800|NCT00917384||In the Participant Flow participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
744801|NCT00917267||
744802|NCT00917124|"Assessed for eligibility (n=287) Excluded (n=87)
~Not meeting inclusion criteria (n=79)
~Declined to participate (n=8)"|
744803|NCT00916929|Patient enrollment began on June 9, 2009 and ended on June 30, 2010. All patients had to be implanted at least 31 days prior to enrollment with a legally marketed St Jude Medical device capable of enabling the impedance monitoring feature.|
744804|NCT00916721|Treatment seeking adults smokers were enrolled from May 2008 to March 2010 at the Center for Addiction Medicine of the Massachusetts General Hospital, in compliance with the Declaration of Helsinki, the U.S. Food and Drug Administration guidelines, and the International Conference on Harmonization Good Clinical Practices Guidelines.|39 were excluded before randomization: Did not meet inclusion criteria (21),Declined to participate (18) Three participants were discontinued before receiving study medication: due to bradycardia (1), cocaine use (1), recent use of albuterol (1)
744805|NCT00916643|A total of 113 patients received over 6,000 combined H.E.L.P. treatments at six sites between 2000-2009.|
744806|NCT00916617|Participants who completed the parent Study NCT00663026 and met the study criteria were enrolled and randomized into each of 3 dose cohorts to receive bapineuzumab or placebo. The study was terminated early on 06 August 2012 because 2 Phase 3 studies showed no clinical benefit. The decision was not based on any new safety concerns.|
744807|NCT00916578|Primary objective is to determine the rate of responses by RECIST criteria in all patients who received treatment that includes pre-operative or palliative concurrent radiation with capecitabine to the breast and at risk or involved regional lymph node basins. The recruitment process was located at MD Anderson Cancer Center between 2009 to 2012.|
744808|NCT00916539||
744809|NCT00916383|The study was conducted at 7 clinical sites during May and June 2009. Patients received 1 placebo patch and 1 Donepezil Transdermal Patch, each applied to opposite sides of the body. The 7-day patches were applied to 1 of 3 consecutive body locations according to 1 of 6 treatment sequences for a total treatment period of 21 days.|Patients diagnosed with Alzheimer's disease who were on a stable course of oral Aricept (10 mg/day) were randomized into the study. Patients discontinued oral Aricept on Day -1 and resumed their original established dose following removal of the last patch.
745012|NCT00906074||289 participants were screened and 109 were excluded from analysis due to: no matching control, not meeting inclusion/exclusion criteria or did not meet matching criteria.
744810|NCT00916370|Subjects enrolled into this trial will be male and female subjects from the general interventional cardiology population. The study commenced on June 5, 2009 with the first subject enrolled on June 15, 2009. The last subject in the CSR was enrolled February 12, 2010, and the last subject enrolled in LLR was on April 6, 2010.|Intention-to-treat (ITT) set includes 525 subjects: 415 in core size registry (CSR) arm and 110 in long lesion registry (LLR) arm. Full analysis set (FAS) (n=505, 401 in CSR arm and 104 in LLR arm) includes subjects who have received at least 1 of the following: the core size XIENCE PRIME or XIENCE PRIME LL stent system, including bailout.
744811|NCT00916357||
744812|NCT00916344|In this study the data of n = 175 patients from 34 clinical sites in Austria, Denmark, France, Germany, Spain, Sweden and United Kingdom are included. The period of investigation covered was between June 04, 2009 (day of first implant) and February 26, 2010 (day of last follow-up).|
744813|NCT00916305||264 assessed for eligibility: 9 excluded 190 did not take initial survey - no reasons given
744814|NCT00916279|Enrollment from June 3, 2009 through December 8, 2009 at 7 centers in Germany, Netherlands, and Belgium.|
744815|NCT00916149|5 subjects enrolled in the Lamotrigine arm. They underwent study procedures, including EEG. The study aim was to compare subjects with and without frequent discharges on EEG. None of these subjects had frequent discharges, and no additional subjects could be recruited. Hence, planned comparisons could not be made and the data were not analyzed.|
744816|NCT00916136||
744817|NCT00916058||Four subjects were ineligible and therefore never started treatment.
744818|NCT00916032|Enrollment was conducted in Russia and Bulgaria at 4 clinical sites.|29 participants were enrolled. Six participants discontinued, (four were screen failures and two were withdrawn before randomization). Therefore 23 participants were randomized.
744819|NCT00916006|Study PEP005-016 was conducted at 21 study centers in the United States and Australia. A total of 269 patients were randomized. Patient screening was started on 01 June 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 10 September 2009|
744820|NCT00915967|214 subjects signed consent. 198 subjects were enrolled.|
744821|NCT00915954||
744822|NCT00915928|Neurosurgical clinic|
744823|NCT00915902|Patients were recruited from Nemours Alfred I. duPont Hospital for Children, Johns Hopkins University and Thomas Jefferson University. Recruitment took place between July 2009 and December 2011.|Patients completed a 4 week dietary run-in prior to randomization at visit 2.
744824|NCT00915876||
744825|NCT00915798|Smokers and nonsmokers with and without ADHD|
744826|NCT00915772||In this study, 567 patients were entered and randomised, but only 566 were treated. Therefore the treated set (TS) comprises 566 patients.
744827|NCT00915759||
744828|NCT00915655||
744829|NCT00915603||
744830|NCT00915590|Patients in this study were recruited from Mass. Eye and Ear Infirmary from May 2009 - February 2010.|This is a single site, randomized, double masked, crossover, phase I/II study of topical IL-1Ra (5.0%) in subjects with corneal neovascularization.
744831|NCT00915551|Study PEP005-025 was conducted at 21 study centers in the United States (19) and Australia (2). A total of 278 patients were randomized (255 (92%) in the US and 23 (8%) in Australia). Patient screening was started on 05 May 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 02 September 2009.|
744832|NCT00915538||
744833|NCT00915525|This was a long-term follow-up study that enrolled patients after participation in the preceding studies 191622-095 (NCT00910845) and 191622-520 (NCT00910520). A total of 829 patients received at least 1 BOTOX treatment in Study 191622-096 or in the preceding studies.|Following a planned interim analysis, the protocol was amended to remove the option to escalate to the 150U dose. The dose groups reflect the highest dose received (i.e. 100U BOTOX includes patients who only received 100U throughout the study and 150U BOTOX includes patients who received at least 1 dose of 150U at any time during the study).
744834|NCT00915499||
744835|NCT00915473|Subjects were recruited by referral from multiple neurologists in the division of Headache at Mayo Clinic in Arizona from June 2009 to October 2012.|
744836|NCT00915356|The 1st patient was enrolled in the study on 25 May 2009, and the last patient completed the study on 4 December 2009. In total, 228 patients were enrolled (at 33 centres) and of the 171 patients randomised 170 patients completed the study. There was no discontinuation of the Investigational Product (IP) due to an Adverse Event (AE) in the study.|An enrolment visit (Visit 1) was done within 14 days before scheduled randomisation. Patients who fulfilled criteria and signed the informed consent form, could then be randomised at visit 2. The patients were to have ongoing Atrial Fibrillation with a clinical indication for cardioversion of Atrial Fibrillation (AF).
744837|NCT00915343||Study consisted of Part A (cross-over) and Part B (open-label). Of the 64 participants started and completed Part A, 5 participants did not enter Part B (treatment switch=2, withdrawal by participant= 2, nausea and abnormal laboratory value=1), 59 started Part B of the study.
744838|NCT00915278||
744839|NCT00915148|Medical contact during10 months|No participants were excluded
744840|NCT00915031|Eligible patients will be given written and verbal explanation of the study objectives; procedures; potential risks; measures taken to protect confidentiality; any associated costs; alternatives; new findings; and investigator disclosures. Patients will be given time to ask questions.|
744841|NCT00915018||
744842|NCT00915005|A total of 149 lung non-small cell lung cancer (NSCLC) patients with stage II to IV or recurrent tumor were consented, randomized, and treated under 2008-0133 protocol from June 2009 to March 2014. Intensity-modulated (photon) radiotherapy (IMRT) in 92; passive scattering proton therapy (PSPT) in 57.|A total of 275 NSCLC patients were consented. 2 patients were consented twice and 1 person denied by Massachusetts General Hospital.47 patients were excluded before the planning process began. 44 patients did not allow random assignment. 32 patients were not treated according to protocol allocation.
744843|NCT00914966||
744844|NCT00914940|Participants were recruited based on physician referral at 2 academic medical centers between Dec 2009 and Oct 2014. The first patient was enrolled on December 17, 2009 and the last participant was enrolled in October 2014|
744845|NCT00914927||
745013|NCT00906035||
745014|NCT00905840||
745015|NCT00905827||
744846|NCT00914862|Participants took part in the study at one investigative site in the United States from 02 November 2009 to 03 April 2011.|Participants were enrolled into one of five treatment groups by age and assigned to either 4 mg or 8 mg ramelteon.
744847|NCT00914849|The study opened to participant enrollment on 08/12/2009 and closed to participants enrollment on 01/31/2011.|
744848|NCT00914810|Participants from the Minneapolis Veterans Affairs Health Care System were recruited as a convenience sample between January 2009 and October 2011 from outpatient pulmonary clinics and an institutional review board-approved database of patients with COPD.|
744849|NCT00914589|Of a total of 32 initiated trial sites, 30 sites randomised and dosed at least one patient. The country distribution for these 30 sites was as follows (number of sites per country in parenthesis): Canada (5), Denmark (1), Germany (4), Great Britain (3), Israel (2), Italy (2), Japan (4), Spain (3) and the United States (6).|Seventy (70) of 479 subjects randomised in the trial were withdrawn before trial product administration.
744850|NCT00914485||
744851|NCT00914459||
744852|NCT00914316||
744853|NCT00914186|Recruitment period for the study started 03Jun09. It was the responsibility of the PI for advertisement and recruitment of the study.|There was a seven day run-in-period in which subjects self-applied the Vehicle control twice daily.
744854|NCT00914069||Prior to assignment to groups, two subjects withdrew from the study. Also prior to group assignment, one subject did not have a consent form and was excluded from the study.
744855|NCT00913978|50 patients were consented to participate, 4 were withdrawn from the study to leave an analysis sample of 46 subjects. The study was terminated early due to financial constraints from the sponsor.|
744856|NCT00913913||
744857|NCT00913835||Participants from liposomal doxorubicin (Lip Dox) treatment group who had progressive disease (PD) had the option to receive to Olaratumab (Olara) monotherapy. Participants who had evidence of PD, died in either period, or received optional Olaratumab monotherapy from liposomal doxorubicin monotherapy were considered to have completed the study.
744858|NCT00913770||
744859|NCT00913744|First subject was enrolled on 29 Jan 2010 and last subject completed the study on 06 Dec 2012|
744860|NCT00913692|Recruitment began in November 2009 at the NIH Clinical Center outpatient clinic. Eleven study participants were enrolled and screened from 11/2009 - 11/2010. Two of these participants proceeded to the treatment phase of the study.|Participants were enrolled and randomized to the treatment phase only if they met the eligibility criteria after completing the 4 month screening phase. After completion of phase 1 of treatment, there was a 2 week wash out period before beginning phase 2 of treatment.
744861|NCT00913627||
744862|NCT00913523||
744863|NCT00913510||The study had a screening period between enrolment and randomization. Four (4) of the enroled patients were never randomized due to either withdrawal of consent or not fulfilling inclusion/exclusion criteria at randomization.
744864|NCT00913458|This report presents the results of open-label 52-week treatment period (Phase 1), 39 week, double blind randomized (Phase 2) and 26 week observational period (Phase 3) part of a 121 week Phase 4 study program. Responders in Phase 1 were randomized to 3 arms (1:1:1 ratio) in Phase 2. Responders in Phase 2, continued to Phase 3 observational period|Phase 1 responders, defined as subjects with Disease Activity Score based on 28-joints count (DAS28) ≤ 3.2 at Week 39 and DAS28 <2.6 at Week 52, were randomized to Phase 2. The responders of Phase 2 were observed for 26-weeks in Phase 3 study that include 2 to 4 week period of double blind treatment taper of MTX followed by observational period
744865|NCT00913380|Dates of the recruitment period: September 2009 to January 2011 Types of location: an emergency department in an urban tertiary hospital in Korea|None of the enrolled participants were excluded from the trial before assignment to group.
744866|NCT00913263|Patients were recruited from the pool of patients with prostate cancer (T1-T2) available at the clinic. They were informed about the study by the Investigator|There was only one Group assignment for the study. The patients (men with histologically confirmed localized prostate cancer, verifyed by biopsy), aged ≥ 45 years, with PSA value <20ng/mL, within 6 weeks before enrollment, and and Gleason score <3+4 at diagnostic biopsy.
744867|NCT00913133|Patients were recruited between April 5, 2010 and February 18, 2011. Patients were recruited from inpatient medical and surgical services as well as surgical clinics when presenting for pre-operative services.|
744868|NCT00913081|The study enrolled healthy volunteers aged 21 to 75 years. Subjects were recruited at the University of Pennsylvania CTRC following a screening visit to confirm eligibility based on an interview reviewing their health status and medication use, baseline laboratory assessment and the ability to tolerate a 500 mg dose of immediate-release niacin|Subjects meeting inclusion criteria, able to tolerate 500mg of immediate-release niacin and to provide informed consent were randomized to one of the four study groups. First experimental visit was within 12 weeks of screening visit.
744869|NCT00913003||
744870|NCT00912990|Subjects were screened and enrolled at a single, pediatric hospital site.|
744871|NCT00912964||After screening, 2030 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 1306 eligible patients were randomly assigned to receive placebo, mirabegron 25 mg or mirabegron 50 mg for 12 weeks.
744872|NCT00912925||
744873|NCT00912912|Recruitment Period: May 29, 2009 to July 29, 2010. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.|Study was closed early due to low rate of response and slow accrual.
744874|NCT00912808|Adult subjects were those diagnosed with probable idiopathic PD, defined as manifesting two of three cardinal features (tremor, rigidity, bradykinesia), without any other historical or physical signs to suggest another diagnosis, and were recruited from the Oregon Health and Science University (OHSU) Movement Disorders clinic.|This is a cross-over treatment trial. Each drug phase, donepezil or identical placebo, lasted 6 weeks, with a three week washout period in between. In each drug phase, subjects were instructed to take one tablet (mg of donepezil or placebo) for three weeks and to increase to two tablets (10 mg) for the remaining three weeks.
744911|NCT00911144||Two subjects enrolled in the protocol received commercial Prevenar and Hiberix vaccines instead of the clinical vaccines planned to be injected and are as such not included in the number of started subjects below.
744912|NCT00911053||The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
744875|NCT00912795|Participants were recruited in Ankara, Turkey between December 2010 & June 2011, through in-person outreach at local shopping malls and local newspapers advertisements. Flyers were also posted at Hacettepe University. Smokers indicated their interest by calling the study office or speaking directly with the research assistant at the shopping mall.|Of the 247 people who expressed interest in participating, 230 were eligible for the study. A total of 151 adults (66% of those eligible) attended the enrollment meeting, where they consented to take part in the research study and were randomly assigned to either the intervention or control group.
744876|NCT00912782||107 Assessed for Eligibility with 55 Excluded for declining to participate (12), not meeting criteria (41), and other reasons (6) leaving 52 patients randomly assigned for the study. Some individuals were counted as having more than two reasons to be excluded from the study.
744877|NCT00912743|Target accrual: 54 subjects. MSI-H group: 15; non-MSI-H group: 39. Pre-planned interim analysis of the non-MSI-H cohort, after 17 patients, stopped recruitment into that cohort. Recruitment to the MSI-H cohort continued.|Subjects with stage IV, measurable disseminated CRC incurable by surgery, with tumour progression following standard combination front-line or second-line chemotherapy, relapsed or recurrent disease within 6 months completing adjuvant or neoadjuvant chemotherapy and met all inclusion/exlusion criteria.
744878|NCT00912509||
744879|NCT00912405||
744880|NCT00912340|Patients were recruited at Winship Cancer Institute of Emory University, Emory University Hospital Midtown, and Robert H. Lurie Comprehensive Cancer Center of Northwestern University.|70 participants were enrolled. Nine were found to be ineligible. Three declined to participate and were not treated.
744881|NCT00912301|Participants were enrolled between April 17 and November 20, 2009 from 150 mile geographical area around Mayo Clinic, Rochester, MN.|40 patients signed informed consent, but 3 failed screening due to presence of evacuation disorder, and 1 withdrew prior to study due to illness.
744882|NCT00912288||
744883|NCT00912223|Participants were enrolled between April 2009 and November 2012 from 21 different transplant centers.|
744884|NCT00912197||
744885|NCT00912158|Location: Respiratory and Coronary Intensive Care Units of Assiut University Hospital. Patients with acute cardiogenic pulmonary oedema (CPE)|All enrolled participants were assigned to one of the three studied groups.
744886|NCT00912093||
744887|NCT00912028||
744888|NCT00912015||
744889|NCT00912002||
744890|NCT00911989||
744891|NCT00911937||
744892|NCT00911898||
744893|NCT00911859|The study was conducted at 40 centers in 12 countries: Australia; France; India; Israel; Italy; Poland; Romania; Russian Federation; Singapore; South Korea; Spain; and the United States.|In Part 2, 105 participants received treatment (VMP: 53 and VMP+Siltuximab: 52). In the VMP+Siltuximab arm, 21 participants who achieved partial response or better entered the maintenance period and received only Siltuximab for 18 months, or until disease progression, unacceptable toxicity, or withdrawal from treatment, whichever occurred first.
744894|NCT00911820|Patients were enrolled between July 2009 and April 2011.|
744895|NCT00911807|Dates of recruitment period: 18-OCT-2004 - 29-OCT-2007 Type of location: hospital (La Coruna), institutions specialized on cognitive disorders (Granada, Malaga)|Patients were excluded from the trial before assignment to groups when not all inclusion criteria were met or when exclusion criteria were applicable.
744896|NCT00911768|Patients were recruited from the waiting room and consulting room of Oriental Clinic of Gastrointestinal diseases and Chronic fatigue of Kyung Hee East-West Neo-Medical Center (Seoul, Korea) between September 2007 and February 2008|Totally, 133 participants were enrolled in the trial; 100 participants screened and 33 of them (women 18, men 15) were excluded because of abnormal liver function (1), present illness (2), a plan to pregnancy (1), and self refusals or disconnections (28).
744897|NCT00911742||
744898|NCT00911625|Recruitment for this study took place at Loyola University Medical Center (Maywood, IL), Rush University Medical Center (Chicago, IL), and Northwestern University Medical Center (Chicago, IL) between January 2009 and May 2011|
744899|NCT00911612|All participants were recruited from the Mayo Clinic in Rochester, Minnesota from January through May 2009. 31 subjects signed consent, 1 withdrew consent before the start of the study, 2 had concomitant illness and 4 did not qualify based on colon transit eligibility criteria. 24 subjects were randomized and were included in the analysis.|
744900|NCT00911586||
744901|NCT00911547|"Patients were recruited at 22 sites in the United States (US) and 48 sites in 16 other countries in North America, Europe, Africa, Australia, and Southeast Asia.
~Publication incorrectly listed 18 participating countries. Results posting is correct with 17 countries.
~Prime therapy period: March 1995 to April 1996."|Patients received inhaled beclomethasone (200 μg twice daily) starting at the Prestudy Visit and continuing through the single-blind run-in period. Patients who experienced worsening asthma requiring more than albuterol therapy (inhaled or nebulized) did not qualify for randomization.
744902|NCT00911534||Out of the 305 participants who were enrolled into the study, 300 participants received the study treatment.
744903|NCT00911508|Between November 2009 and April 2016, 2204, patients with atrial fibrillation from 126 sites across 10 countries, were randomized in equal proportions to either catheter ablation or drug therapy, using permuted block randomization with stratification by clinical site.|
744904|NCT00911495|First subject enrolled 28 May 2009; last subject completed 6 July 2010.|
744905|NCT00911443|Recruitment started on August 2002 and has been completed on January 2006. All patients were recruited at medical clinic facilities (Oncology/Dermatology departments)|Only patients who did not meet the entry selection criteria were excluded from study entry.
744906|NCT00911326||
744907|NCT00911300||Participants (par.) were required to undergo transesophageal echocardiography (TEE) to guide cardioversion (CV). TEEs were recorded and archived to allow for later central adjudication and possible evaluation of details. At randomization (Day 1, immediately after TEE), par. were stratified to thrombus (clot)-positive and thrombus (clot)-negative.
744908|NCT00911274||
744909|NCT00911170|The first participant was enrolled into the study on 03 November 2009 and the last participant on 03 January 2012.|This study included a a study treatment period (approximately 8 weeks), and a long-term follow-up period (up to 36 months after the last participant was enrolled).
744910|NCT00911157||
744914|NCT00910962|A total of 535 participants, with myocardial infarction without ST segment elevation, were randomized to the study of which 526 participants received at least one dose of study drug. The study was conducted at 83 centers, from 08 October 2009 to 06 March 2012.|
744915|NCT00910910|118 sites randomized participants in Austria, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Hungary, Israel, Italy, the Netherlands, New Zealand, Poland, Portugal, Romania, Russia, South Africa, Slovakia, Spain, Serbia, the United Kingdom, and the United States of America|Participants were randomized 1:1 to lenalidomide or chlorambucil and stratified by disease stage, presence of pre-defined co-morbidities and presence of at least one of the following poor prognostic factors: 11q deletion, 17 p deletion, unmutated IgVH and B2M>4.0 mg/dL.
744916|NCT00910871|A Phase II open label trial with TMC207 as part of multi-drug resistant mycobacterium tuberculosis (MDR-TB) treatment regimen in participants with sputum smear-positive pulmonary infection with MDR-TB.|A total of 241 participants were enrolled in the study; 8 participants were withdrawn from the study before study drug administration and 233 started treatment with study drug.
744917|NCT00910858|A total of 40 participants were enrolled at 1 site in this study, with 12 participants enrolled in the Pharmacokinetic (PK) Phase of the study, 39 participants enrolled in the Monotherapy Phase of the study, and 23 participants enrolled in the Combined Treatment Phase of the study.|The Monotherapy Phase included an initial group of 24 patients (11 from the PK Phase and 13 newly enrolled) who participated in the multiple-dose PK assessment and a second group of 15 patients (15 mg Non-del 5q) for whom no PK samples were taken. Erythroid nonresponders or responders who relapsed could participate in the Combined Treatment Phase.
744918|NCT00910845||
744919|NCT00910728|Commenced 19MAY2009. All subjects recruited to Part A only (based on emerging data). 65 patients were enrolled of which 35 recieved at least 1 dose of AZD1480.|Patients ≥25 years of age with primary myelofibrosis (MF) and post-polycythaemia vera/essential thrombocythaemia MF who had relapsed, were intolerant of, or were refractory to MF-directed therapy were enrolled.
744920|NCT00910715|"Patients older than 15 years evaluated between June and October 2009 at the Lyme Borreliosis Outpatient Clinic, University Medical Center Ljubljana, Slovenia were eligible for the study if they had typical solitary erythema migrans as defined by CDC.
~Patients were asked to refer a spouse/friend of the same age ± 5 years to serve as a control."|241 were evaluated for enrollment and not enrolled in the study.
744921|NCT00910689|Outpatient clinics|5 week Optimal Acute Therapy (OAT) Run in (M1) precedes random assignment (see detailed design description).
744922|NCT00910663||
744923|NCT00910624||168 participants enrolled and received at least one dose of study medication. Participants were categorized by prior treatment response on the referring study: prior null response, prior partial response, prior relapse, or other.
744924|NCT00910520||
744925|NCT00910429|Study was conducted at 71 centers in 25 countries or regions, between 01-JUL-2009 (first participant first visit) and 19-AUG-2019 (last participant last visit)|Of the 243 participants who completed CHEST-1 (NCT00855465), 237 entered CHEST-2. 155 participants were from the former riociguat treatment group, and 82 were from the former placebo group.
744926|NCT00910299||
744927|NCT00910273||
744928|NCT00910247|Subjects that participated in either study 093-045NCT00866775) or study 093-046(NCT01091662) were eligible to participate in study 093-050|Subjects who completed the 18-week treatment period or exited the study per protocol may be eligible to participate. Subjects who discontinued for reasons other than reaching the exit criteria may be eligible if there is no safety concern, however, subjects must have completed at least the first 3 weeks of the 18-week double-blind treatment
744929|NCT00910208|Recruitment started April 3, 2009 and ended June 30, 2010. Patients were recruited by bilingual research associates in the Emergency Department of Jacobi Medical Center, Bronx, NY|
744930|NCT00910091||
744931|NCT00910039|Fourteen patients were entered onto this trial between 8/2009 and 6/2011 from Cleveland Clinic and Henry Ford Health System.|
744932|NCT00910000|15 participants were enrolled and treated between July 2009 and January 2013. One patient excluded from all analyses failed screening after consent because of elevated liver function tests and did not receive treatment.|
744933|NCT00909870|"Screening commenced in May 2009 and ended in November 2010.
~Study sites included vascular surgery, dermatology, and podiatry clinics.
~A total of 913 potential subjects were screened across 58 study centers; 395 subjects were screen failures.
~A total of 537 subjects were enrolled across 49 study centers."|Prior to study enrollment, all subjects signing informed consent proceeded through a two-week run-in phase in which all subjects received standard-of-care study ulcer treatment. During this phase, any subject not meeting inclusion/exclusion criteria was considered a screen failure and removed from the study.
744934|NCT00909857|Participants aged 14 to 50 years with a need for oral contraception suffering from primary dysmenorrhea were recruited at specialized study sites.|Out of 771 participants screened, 264 failed screening, mostly due to not meeting in-/exclusion criteria (155), withdrawal of consent (49), loss to follow-up (36) or pregnancy (10). Thus, 507 participants were randomized (253 to Estradiol valerate/Dienogest and 254 to Ethinyl estradiol/Levonorgestrel).
744935|NCT00909844|The study was designed as a multicentre study and included 10 investigational sites in France. This follow up study was to start on the day of the last visit (Month 6) of the phase III 2-54-52014-143 study and was to end when the Investigator judged that the patient had completed his/her treatment, i.e. at around 11 years in girls and 13 in boys.|A maximum of 35 patients could be included in this study (i.e. the number of patients who had completed the phase III 2-54-52014-143 study). A total of 35 patients were screened and enrolled in this current study (2-54-52014-159).
744936|NCT00909792||One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
744937|NCT00909779||
744938|NCT00909753||
745016|NCT00905632||75 patients were screened, however only 57 patients were randomised.
745017|NCT00905606||
745018|NCT00905580||
745019|NCT00905567||
745020|NCT00905554|medical clinic since march 2009 until sample size was reached|no patient excluded from the study flow after being allocated in the study or control arm
745021|NCT00905515||
749183|NCT00700310||
744939|NCT00909727|Part A started on 05 August 2009 (signing of first informed consent). Screening evaluations were completed during Day -28 to Day -2. All subjects completing Part A were offered the opportunity to participate in Part B, which started on 12 March 2010. Screening evaluations were completed during Day -35 to Day -15 before the first dose of study drug.|Nine subjects were dosed and included in Part A. In Part B, 52 subjects were enrolled and all were randomized to ivacaftor (26 subjects) or placebo (26 subjects). A 2-week run-in period was included to establish the baseline assessments on Day 1 after ensuring that subjects were properly taking their cystic fibrosis (CF) medication regimens.
744940|NCT00909649|medical clinic|
744941|NCT00909610||
744942|NCT00909545||
744943|NCT00909532|The study started on 10 June 2009 (signing of first informed consent). After obtaining consent and assent (where applicable), screening evaluations were completed during a period of 2 to 5 weeks (Day -35 to Day -15) before the first dose of study drug.|A total of 167 subjects were randomized; 161 subjects received at least 1 dose of the study drug. A 2-week run-in period was included to establish the baseline assessments on Day 1 after ensuring that subjects were properly taking their cystic fibrosis (CF) medication regimens.
744944|NCT00909480|There were a total of 85 trial sites in 5 countries: 70 in the United States of America (USA), 5 in Thailand, 4 in Korea, 2 in India and 4 in Argentina|After randomisation, the dose and dosing frequency of metformin were maintained throughout the trial in both treatment arms. Other oral anti-diabetic drug (OAD) was discontinued before use of trial product
744945|NCT00909428|Fifty-one individuals were consented and 42 women with overactive bladder (OAB) received study drug between January 2007 and February 2009. Participants were recruited using physician solicitation.|Following informed consent, nine women were negative for OAB and did not receive solifenacin succinate
744946|NCT00909389||
744947|NCT00909363|"24 patients' families signed consents
~11 WAS patients for treatment: 1 mother signed consent but never consented to have her very young baby start study treatment (dietary issues) + 1 withdrew
~8 WAS patients' parents only were willing to have study bloods drawn
~5 normal healthy children had their parents give consent for a blood draw"|
744948|NCT00909324||
744949|NCT00909220|Participants from each group were recruited from the same community locations via advertisements and the internet. Enrollment began 5/2009 and ended 7/2011.|All depressed participants were enrolled into the Behavioral Activation Treatment arm. All healthy participants were tracked for the duration of the study.
744950|NCT00909181|Recruitment in clinical sites (urologists mainly) started in September 2007 and was terminated in February 2010.|Baseline period was 1 week. Patients on OAB drugs had to wash out.
744951|NCT00909155||
744952|NCT00909090|Recruitment was initiated in May, 2009. The enrollment period was rolling and lasted for 30 months. Enrollment closed in November, 2011. Participants were recruited from the local Athens, Clarke-County community and the University of Georgia student population.|"Key events:
~Telephone screening to confirm eligibility Enrollment Randomization"
744953|NCT00909064||
744954|NCT00909038||
744955|NCT00908960||
744956|NCT00908947|First subject enrolled on February 9, 2011 and the final follow-up was completed on September 19, 2018.|
744957|NCT00908908|This study was recruited at 1 center in The Netherlands during the period of Mar 2009 to Jun 2009.|
744958|NCT00908895|Recruitment started in April of 2003 and finished in June of 2006.|Only surgical fractures were addressed to the research team, after prior selection by orthopedic surgeon. So we didn't see all radius fractures in the department.
744959|NCT00908882||
744960|NCT00908830||
744961|NCT00908791|Women with invasive breast cancer were recruited from the Breast Oncology Clinic at the Norris Cotton Cancer Center at the Geisel School of Medicine at Dartmouth from June 2009 to March 2011. All patients gave written informed consent before entry into the study.|Participants must have been able to take the study drug for a minimum of 10 days prior to tumor resection. For some potential participants the surgery date was scheduled earlier than 10 days and the study drug was not dispensed.
744962|NCT00908687||
744963|NCT00908648|Gastroenterology Unit November 2007 - April 2008|Patients undergoing incomplete procedure for inadequate bowel cleansing or failure to reach the cecum were excluded from randomization
744964|NCT00908596|The first participant's first visit was on 21 May 2009. 35 study centers in Australia, Austria, Germany, Italy, Spain, South Korea, UK, USA, and Thailand screened and enrolled participants scheduled to undergo contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist within the approved indications.|A total of 364 participants were enrolled. Of these, 4 were withdrawn prior to magnetic resonance imaging (MRI) already since they failed to meet the study entrance criteria, and 3 were withdrawn for other reasons. Participants had to have moderate to severe renal impairment (estimated glomerular filtration rate [eGFR] 65 mL/min/1.73 m^2 or less).
744965|NCT00908583|Subjects could be enrolled in multiple study phases. Enrollment in phases 1-2 was an adaptive approach and was fixed a priori in Phases 3-5. The adaptive approach was based on treatment effect (immunodominant antibody (iAb) reduction).|44 subjects received 52 treatments in this study. 7 subjects were enrolled in multiple phases. Four patients received treatment in two study phases (two patients were enrolled in Phases 1 and 2, one patient was enrolled in study Phases 1 and 3, and one patient was enrolled in Phases 2 and 3). One patient was enrolled in Phases 1, 2 and 4.
744966|NCT00908544||Overall 47 patients signed informed consent, of which 42 participated in the study; five patients turned out to be screening failures due to nonfulfillment of the eligibility criteria (tropism test showed X4 tropism in three patients or Western blot bands >2 in two patients).
744967|NCT00908466||
744968|NCT00908388||
744969|NCT00908375||
744970|NCT00908349||
744971|NCT00908310|There were 213 subjects enrolled in this study. Total of 202 subjects evaluated for safety purposes. Total of 153 subjects completed this study. Total of 11 subjects discontinued prior to contrast administration (no contrast media received).|
744972|NCT00908232||190 patients screened, 163 enrolled and received Bortezomib-Dexamethasone (VD) . Participants that completed cycles 1 to 4 were assessed for Response. Complete or Partial Responders were not randomized and continued on VD for cycles 5-8. Participants with Stable Disease (SD) were randomized to either VD, VDC, or VDR for cycles 5-8.
744977|NCT00908037|Pediatric participants (par.) meeting eligibility criteria were enrolled into 3 cohorts depending upon age. Cohort 1 enrolled participants who were between 12 and 17 years old, Cohort 2 enrolled participants who were between 6 and 11 years old, and Cohort 3 enrolled participants who were between 1 and 5 years old.|15 par. were randomized to a 24-Week (Wk) Open-Label (OL) eltrombopag Dose-Finding period (pd) (Part 1) then did not continue. 67 par. were randomized to a 7-Wk Double-Blind placebo-controlled pd (Part 2), followed by a 24-Wk OL eltrombopag-only pd (Part 2/3) and a 4-Wk Follow-Up pd.
744978|NCT00908011||
744979|NCT00907907||
744980|NCT00907881||
744981|NCT00907803|This study was conducted at three sites: Apex Research Institute, Santa Ana, CA, Hawaii Clinical Research Center, Honolulu, HI, and Orlando Clinical Research Center, Orlando, FL. The study was conducted in male and female volunteers ages 18 - 75 years inclusive from the sites' databases.|Following an up to 14-day Screening Period, eligible subjects were randomly assigned to receive either ST-246 400 mg (n=45) or ST-246 600 mg (n=46) or placebo (n=16). Treatment was orally administered after a light meal over a 14-day Treatment Period. There was a 28-day Follow-up Period.
744982|NCT00907777||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
744983|NCT00907738||
744984|NCT00907621|The inclusion period was from September 2009 to December 2012.13 GP offices participated. The participating doctors were all GP specialists with a minimum of 300 hours of acupuncture education and fi ve years of practising acupuncture. The patients fulfi lled Wessel ' s criteria and were born at full term.|113 pasients were recruited. 23 were excluded beacuse of spontanous improving of symptoms, transportation problems, change of mind regarding participation.90 patients were randomized. 79 crying diaries and 84 interviews were analysed.
744985|NCT00907517||Only one combination treatment cycle of approximately 4 to 6 weeks duration was anticipated, but participants may have received additional cycles of treatment if clinically indicated after discussion between the Investigator and the Sponsor.
744986|NCT00907478|Eligible patients were adults diagnosed with immune (idiopathic) thrombocytopenic purpura (ITP) with a platelet count < 50 x 10^9/L. The first patient enrolled 11 August 2009 and the last patient was enrolled 11 November 2010. Participants were enrolled at 60 study centers in Australia, Europe, and North America.|204 patients were screened, 35 were considered screen failures. Participants were enrolled sequentially into the following cohorts: • Bone marrow biopsy at Baseline and Year 1 • Bone marrow biopsy at Baseline and Year 2 • Bone marrow biopsy at Baseline and Year 3.
744987|NCT00907426||
744988|NCT00907374||46 patients were enrolled and entered the run-in but 19 were not randomized
744989|NCT00907335||
744990|NCT00907296|This study was conducted at 66 centers in Europe, India, North America, Australia, New Zealand, Hong Kong, and Mexico. Participants were enrolled from 02 September 2009 to 19 September 2011.|Participants were randomized 1:1:1:1:1:1:1:1:1:3 to 1 of 9 romosozumab treatment groups or placebo. Randomization followed surgery and was stratified by type of fracture and definitive fracture fixation.
744991|NCT00907257||
744992|NCT00907218|2 studies were recruited. They participated in a previous study in our department and signed consent for the data to be used for this study.|Recruitment was extremely slow and therefore the study was terminated early
744993|NCT00907153|36 patients were screened for eligibility between July 2009 and November 2010 at Medicine and Obstetrics and Gynecology clinics at an academic medical center in Hershey, PA.|28 of 36 participants were randomized. Of those not randomized, 3 did not meet inclusion criteria, 3 declined to participate, and 2 were not randomized for other reasons.
744994|NCT00907101||
744995|NCT00907088||
744996|NCT00906971|The trial was carried out in the Pediatric Unit at Hospital das Clínicas at Federal University of Pernambuco (UFPE) between May 2009 and May 2012.|
744997|NCT00906945|The study opened to participant enrollment on 02/04/2011 and closed to participant enrollment on 08/19/2013.|
744998|NCT00906789|Recruitment between April 9, 2009 and June 15, 2009. Recruited by email and phone calls to individuals meeting entry criteria specified in the protocl.|All recruited individuals met entry criteria. None were excluded or dropped from the study. Training in the use of studied device (software) occurred immediately prior to the experiment. Training took 55 to 80 minutes, depending on the individuals speed. Each individual served as his/her own control, so all participants were in both groups
744999|NCT00906776||
745000|NCT00906698||
745001|NCT00906503||
745002|NCT00906425||
745003|NCT00906399||
745004|NCT00906373||Participants who died or had progressive disease (PD) were considered to complete the study.
745005|NCT00906347|Women presenting to Labor and Delivery at Parkland Memorial Hosiptal and who met eligibility requirements were offered participation from Decemeber 2008 through January 2001.|
745006|NCT00906282|Between Aug 2009 and Jul 2013, 46 patients with potentially resectable non-squamous NSCLC were enrolled from 10 participating sites in the U.S.|Patients (pts) received up to 4 cycles (12 weeks) of preoperative chemotherapy and were restaged after 6 and 12 weeks. Pts with progressive disease or intolerable toxicity came off study; pts who remained surgical candidates had resection at weeks 15-18. Following resection pts received no further planned protocol treatment.
745007|NCT00906243|A total of 6 subjects entered Phase 1 of the study between June 2009 and December 2009.|
745008|NCT00906204|Trial enrollment occurred between 3/30/2010 and 3/25/2014. Patients scheduled to undergo kidney transplantation were evaluated for trial suitability/enrollment in the transplant hospital or clinic just before transplantation, typically from a few hours to ~24 hours before transplantation.|Occasionally patients were evaluated and thought to be suitable trial candidates until transplantation was imminent, when they were ruled out by last-minute observation of medical problems or donor shortcomings.
745009|NCT00906178|We aimed to screen all 382 female students enrolled in the two mixed-sex schools and 772 of the 2,264 male students enrolled across the four schools to identify 400 eligible youth. Many youth were out of school trying to secure school fees or had changed schools. As a result, 740 of the youth were screened, 416 of whom were eligible (56%).|
745010|NCT00906165||
745011|NCT00906087||
745022|NCT00905489|Multicenter Phase I study in Botswana, Germany, South Africa and the United States.|There was only one treatment group and no randomization process. Overall, 90 pediatric patients were enrolled. Five patients were not entered and 85 patients entered the study. Patients were stratified to the following three age groups: (26 in the 3 - <6 year age group, 26 in the 6 - < 12 year age group and 33 in the 12 - < 18 year age group).
745023|NCT00905450||
745024|NCT00905437||
745025|NCT00905424||246 subjects entered the antidepressant lead-in phase receiving escitalopram oxalate (antidepressant) 20 mg/day for 8 weeks. After 8 weeks, subjects with residual depressive symptoms (n = 177) were randomly assigned (stratified by remission, either remitters or non-remitters) to receive augmentation therapy (either SPD489 or placebo).
745026|NCT00905359||
745027|NCT00905346||
745028|NCT00905307|"459 participants recruited at 74 study centres in the United States, Asia and Europe.
~Participants not responding adequately to treatment at Week 4 visit could continue in study and receive open-label OPC-34712 (starting dose 2.5 mg/day with option for decrease to 2 mg/day or increase to 3 mg/day) until Week 6 at study physician's discretion."|"Partipants were randomized in a 1:2:2:2:2:1 ratio to the following groups:
~OPC-34712 0.25 mg arm, OPC-34712 low-dose, OPC-34712 mid-dose, OPC-34712 high-dose, Placebo, Aripiprazole. All other prohibited medications were discontinued at least 24 hours before the first dose of double-blind study medication."
745029|NCT00905268||
745030|NCT00905255|The study was conducted at 9 centers in Japan between May 09, 2009 and January 22, 2011. The overall duration of treatment was at least 76 weeks (52-week open-label treatment; 24-week open-label extension treatment).|A total of 75 patients were screened of which 6(8.0%) were screen failures; main reasons for screen failure:glycosylated hemoglobin being out of defined protocol range (>=7% and <=10%) and use of an antidiabetic agent other than a sulfonylurea or alpha-glucosidase inhibitor within 3 months prior to screening. A total of 69 patients were randomized.
745031|NCT00905164||
745032|NCT00905151||
745033|NCT00905125|Enrollment began on 11JUN2009 and was closed on 03SEP2009 due to the availability of the 2009-2010 seasonal Influenza vaccine and onset of Influenza season.|
745034|NCT00905034|Recruitment Period: March 6, 2009 to May 6, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
745035|NCT00905021||
745036|NCT00904995|Recruitment Period: 4/2/09 to 8/19/09. All participants registered at The University of Texas M.D. Anderson Cancer Center.|Two of the twenty-three participants registered withdrew prior to their assignment to groups.
745037|NCT00904982||
745038|NCT00904969|10 clinical Sites enrolled and implanted subjects. All subjects gave informed consent prior to enrollment and all implanted subjects met the inclusion / exclusion criteria. Enrollment into the study began in February 2006 and ended April 2007.|Subjects who meet the inclusion / exclusion criteria and were good surgical candidates were enrolled into the single arm study and were eligible to be implanted.
745039|NCT00904943||
745040|NCT00904917|The majority of the mothers were recruited through newspaper ads while remaining participants were recruited from word of mouth, research studies, mental health clinics and other sources.|Eighteen mothers completed the Structured Clinical Interview (SCID), with 16 being eligible to participate in the study, and 1 mother did not complete the baseline interview. Fifteen mothers (with 19 children) were randomized.
745041|NCT00904839||"Maximum Tolerable Dose set (MTD): The first 12-18 patients randomised to the nintedanib treatment group, treated with nintedanib according to the dose escalation part of the study.
~The patient randomised to MTD analysis set were in Phase-1. The final data base lock date for this study was 23 JUL 2013."
745042|NCT00904826|Between October 2009 and November 2010, subjects were directly recruited at the Mayo Clinics in Rochester, Minnesota and Scottsdale, Arizona, or identified through the Mayo Clinic study-specific repository or clinicoserological database.|
745043|NCT00904748||Each participant was to receive each of 3 formulations in 3 treatment periods, after being allocated to 1 of 6 treatment sequences. There was to be a minimum interval of 3 days between treatment periods.
745044|NCT00904722|Recruitment Period: January 08, 2010 to January 05, 2012. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.|Thirty-two patients were enrolled, out of which two patients were ineligible and not treated.
745045|NCT00904670||The study consisted of an open-label (OL) dose-optimization phase (4 to 6 weeks), and a placebo-controlled, double blind (DB) 2-way crossover phase (1 week each) with no dose adjustments.
745046|NCT00904618|January 2007 to October 2008 at Centre Hospitalier Universitaire de Sherbrooke (CHUS)|
745047|NCT00904488||
745048|NCT00904423||
745049|NCT00904371||Phase IV, Post Marketing Surveillance Study, non-interventional, multicentre, national, observational study in routine daily practice.
745050|NCT00904215||
745051|NCT00904189||
745052|NCT00904150||
745053|NCT00904033||
745054|NCT00904007||
745055|NCT00903968|Participants in the Phase I study enrolled from June 2009 - July 2011 and the Phase II study from May 2012 - March 2015.|
745056|NCT00903929||
745057|NCT00903877||
745058|NCT00903786||
745059|NCT00903760|Recruitment period: January 28, 2010 to May 7, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 42 participant enrolled, five were not randomized or treated and are therefore excluded from the trial details. One participant included in group assignment was randomized but not treated as a result of early death.
745060|NCT00903695|Patients diagnosed with Mild Cognitive Impairment (MCI) in VA and OU campus clinics were given opportunity to participate in the trial, if they met inclusion/exclusion criteria.|Over 1.5 yrs, only 19 of 533 memory clinic patients were diagnosed with Mild Cognitive Impairment and who met inclusion/exclusion criteria. Most of the MCI patients had serious medical problems that affected cognition. Ten subjects agreed to be in this study.
745061|NCT00903682||
745062|NCT00903630||Fifteen subjects were enrolled in this combined phase l/ll study - 11 subjects in phase l and 4 in phase ll. Six of the subjects enrolled in phase 1 were treated at the maximum tolerated dose (MTD) and their data was included in the phase 2 analysis as allowed by the protocol.
745063|NCT00903617|This study was conducted at 11 centers in the United States from 15 June 2009 to 16 February 2010.|A total of 80 participant were enrolled in the study. Participants on lipid-altering medications (prescription, over-the-counter and herbal preparations directed at lipid lowering) were washed out of their treatment for at least 6 weeks prior to randomization and 8 weeks wash out for participants on fibrate medications.
745064|NCT00903448|This single-center, double-blind, randomized, 2-treatment, 3-period cross-over study conducted in forty healthy adult subjects living in the vicinity of the site.|
745065|NCT00903409||
745066|NCT00903396||
745067|NCT00903383|There were 43 study centers in 6 countries (10 in the US, 8 in Bulgaria, 4 in Czech Republic, 7 in Hungary, 11 in Poland, and 3 in Serbia). The first subject was enrolled on 31 August 2009, and the last subject completed the study on 30 September 2010.|There was a 4 week screening period prior to the 12-week treatment period.
745068|NCT00903370||
745069|NCT00903357|Childrens(2~6 years old) with moderate to severe atopic dermatitis recruited from the Pediatric Allergy and respiratory Center of the SoonChunHyang University Hospital (Seoul, Korea).|54 participants recruited.
745070|NCT00903344||
745071|NCT00903331|The study was conducted at 48 centers in Australia, Canada, France, Germany, Israel, Italy, Slovenia, South Africa, Spain, Sweden, Turkey, and the USA.|The study included a screening period of up to 28 days followed by a double-blind treatment phase that was further divided into two periods. 300 patients were screened and 178 randomized in a 2:1 ratio to study treatment with ACT-064922 or placebo
745072|NCT00903201|This study was conducted at 16 centers in the United States of America, 6 centers in Germany, 5 centers in France, 3 centers in Israel and 1 center in Canada from 28 September 2009 to 29 December 2010.|Participants were screened for a period of 28 days and at that time their eligibility for study inclusion was assessed. A total of 146 participants with cystic fibrosis were randomized to receive either 20 mg, 50 mg SB656933 or placebo orally for 28 days.
745073|NCT00903175|238 patients were randomized to everolimus as 1st line followed by 2nd line sunitinib. All patients in this group were treated. 233 patients were randomized to the sunitinib as 1st line followed by 2nd line everolimus. However 2 of the 233 patients were not treated in this group.|The trial had a crossover design: first-line therapy until disease progression followed by second-line therapy until disease progression.Patients were randomized 1:1 to either everolimus-sunitinib or sunitinib-everolimus treatment sequence and were stratified by MSKCC risk criteria
745074|NCT00903162|Potential patients were approached in the Dana-Farber Breast Oncology clinic and Newton Wellesley Hospital. Eligible patients were then presented with the study and given an opportunity to sign consent. The recruitment period ran from March 30th 2009 to May 1st, 2012.|A total of 17 patients were enrolled in this study; however, only 16 patients started treatment. One patient withdrew from the study before starting treatment.
745075|NCT00903032||
745076|NCT00903006|Recruitment Period: November 19, 2009 to February 13, 2012. All recruitment done in medical clinical at the University of Texas (UT) MD Anderson Cancer Center.|Out of 11 participants registered to the trial, five (5) were screen failures and thus excluded from the trial. The Phase I portion of study began with the first three arms: 1) Fulvestrant, 2) Fulvestrant + Low Dose Dasatinib and 3) Fulvestrant + Low Dose of MK-0646.
745077|NCT00902850||
745078|NCT00902746|"Total 168 patients were consented and registered at minus 2 cycles of study drug administration as provisional registration.
~After provisional registration, investigators confirmed their eligibility of patients by test gynecological examination, transvaginal ultrasound etc.) and 149 patients were formally registered for this study."|
745079|NCT00902668|Study was open to accrual from 4/21/09 to 3/2/10. Patients were recruited from radiation oncology clinics.|Patients can be registered only after pretreatment evaluation is completed and eligibility criteria are met. Protocol treatment begins on the first day of external beam radiation therapy or on the first day of brachytherapy and continues for 12 months.
745080|NCT00902577|Fifty patients with newly diagnosed GBM were enrolled from 11 academic centers in the United States.|All participants were scheduled to receive both FMISO and MRI (DCE, DSC, DWI, MRS) imaging two weeks before initiation of chemoradiotherapy with temozolomide
745081|NCT00902564||
745082|NCT00902538|First participant visit was 29 April 2009. The last participant follow up was 07 September 2010|The number of subjects entering Period 2 was only 808 because 1278 did not meet the entry criteria.
745083|NCT00902486|The study population included participants diagnosed with RA who had failed to respond adequately to any DMARD therapy, including biologics.|The study was divided into 3 distinct phases: Screening Phase (up to 28 days before randomization), Treatment Phase (12 weeks + 12-week extension period), and the Follow-up (4 ± 1 weeks following final dose of study medication).
745084|NCT00902330|Women with stage I to IIIA breast cancer scheduled to receive chemotherapy with a performance score <2 recruited from five Cancer Centers across Virginia. Previous chemotherapy, dementia or active psychosis, seizure disorder, implanted electrical device, or taking medication psychiatric condition with 30 days prior to enrollment were excluded.|Following completion of informed consent study participants were stratified by initial chemotherapy regimen (dose dense versus non-dose dense) and then randomly assigned to one of two groups: actual or sham CES.
745085|NCT00902304||2337 patients were enrolled. 2185 received study medication during the 4 week run-in period. 1562 patients were randomized.
745086|NCT00902278|We recruited healthy adults subjects during the 2008-2009, 2009-2010, 2010-2011, and 2011-2012 influenza seasons in a clinical research setting.|
745087|NCT00902265|"This was a post marketing, non-randomized surveillance study. The 138 participants were screened from 60 German sites.
~The study planned for two visits - baseline (week 0 and week 12). Participants could opt for an optional visit between week 0 and week 12 (17 participants did not opt for optional visit)."|
745088|NCT00902226||
745089|NCT00902174|Overall, 326 participants were screened, 202 participants were randomized (103 to Imatinib and 99 to placebo). Out of 202 participants randomized 201 participants received study drug treatment (103 received imatinib mesylate, 98 received placebo). One participant was randomized to the placebo group but did not receive any study treatment.|Participants were randomized in a 1:1 ratio to imatinib mesylate or placebo.
745090|NCT00902161||
745091|NCT00902018|patients with persistent or chronic ITP willing to undergo washout period and then multiple visits (7) in 2 weeks period including 3 larger blood draws|
745093|NCT00901901|The study was conducted at 128 study centers in 26 countries in North America, South America, Europe, Africa, and Asia.|Of the 962 screened participants, 242 were screen failures and were excluded from participated in the study. A total of 720 participants were randomized to study arms: 358 participants in the sorafenib + placebo group and 362 participants in the sorafenib + erlotinib group.
745094|NCT00901628|101 patients who were scheduled for unilateral total knee arthroplasty recruitment at Joint Reconstruction Center, Seoul National University Bundang hospital from April 2008 to March 2009 were recruited.|no participant was excluded before assignment
745095|NCT00901576||Study consists of 3 regimens: SPD503 (extended-release guanfacine HCl) single 4 mg dose, Concerta (extended-release methylphenidate HCl) single 36 mg dose, and SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered. Each dosing regimen is separated by a washout period and performed in 6 different dosing sequences.
745096|NCT00901459|The first participant was consented on 5/12/2009 and the final participant on 6/22/2010 at the Duke Center for Nicotine and Smoking Cessation Research. During the recruitment phase of the study 148 potential subjects were consented and 7 read the consent form and chose not to participate.|"Of the 148 participants that were consented for this study only 21 subjects met study criteria the others were excluded from participation for the following reasons:
~70-Did Not Meet Inclusion Criteria 6-Lab Results 6-Lost to Contact 26-Medical 14-Met exclusion criteria 3-Refused to participate 2-Unable To Meet Study Requirements"
745097|NCT00901394|63 patients were consented however only 59 were analyzed.|
745098|NCT00901342||
745099|NCT00901316|"Children with probable community-associated Staphylococcus aureus skin and soft tissue or invasive infections were randomized to routine daily hygienic measures with or without bleach baths twice a week for 3 months."|
745100|NCT00901303||
745101|NCT00901225|The first patient was enrolled in April 2005 and the final patient enrolled in August 2010. The protocol was closed to accrual for approximately 3.5yrs, so the total time to protocol activation was 15 months. This was a single institution study (Duke adult stem cell transplant program).|All patients deemed to be poor mobilizers to G-CSF as a single agent, were eligible for enrollment (assuming protocol eligibility criteria were met).
745102|NCT00901186||
745103|NCT00901017||
745104|NCT00900822|Recruitment started Oct 2005 and was completed June 2006.|Split-mouth design (test and control in the same patient).
745105|NCT00900796||
745106|NCT00900757||
745107|NCT00900731||1598 participants were randomized. 3 participants in the Indacaterol group and 2 participants in the Tiotropium group did not receive study medication.
745108|NCT00900666|Recruiting began in January of 2008 and concluded June 1, 2011. Recruiting sites included:inpatient and outpatient settings of a rehabiliation hospital, local support groups, assisted living and retirement homes. Target of N=60 (30 in each arm) was not met.|Strict inclusion criteria (e.g., walking velocity, rectus femoris spasticity, and target kinematic aspects of peak knee flexion in swing) eliminated many potential participants. 72 participants screened by phone, 30 declined/disqualified, 42 underwent clinical and gait analysis baseline screening, 23 disqualified. A total of 19 were enrolled
745109|NCT00900627|Phase I: 20 patients enrolled, 6 to AZD8931 160mg, 2 to AZD8931 120 mg, 6 to AZD8931 80 mg and 6 to AZD8931 40mg. Phase II: 305 enrolled, 190 randomised, 94 and 96 allocated to AZD8931 40mg + Paclitaxel and Placebo + Paclitaxel respectively. Enrolled patients differs slightly from protocol as focus was on achieving number to be randomised.|
745110|NCT00900601|During the study period, from 2007 and 2010, a total of 20 patients with PGP were referred Oslo University Hospital, but only 9 patients met the study's inclusion criteria.|
745111|NCT00900237||
745112|NCT00900159|The recruitment period was from April 2009 to December 2009. All recruitment happened at Brigham and Women's Hospital in Boston, MA. Recruitment included using advertisements around the Boston area.|
745113|NCT00900146|Study consisted of four periods: screening (Period I), dose-finding (Period II), intermediate (Period III),and long-term continuation (Period IV). Eligible patients were randomized for 4-month treatment of Period II. Intermediate period continued until primary analysis was completed and optimal dose was selected. Study got terminated in Period III.|A total of 556 patients were randomized in Period II. 5 patients one in each 5, 15, 50mg Canakinumab arms and 2 in Placebo were randomized in error, but never received study treatment. All tables reflect the 551 treated patients.
745114|NCT00900029|Eligible subjects were those who completed study 802-247-09-015. Of the 228 subjects who completed 802-247-09-015, 206 consented to enter this safety follow up study, between June 1, 2009 and October, 20, 2011.|Both PIs and subjects remained blinded to the therapy each subject received in 802-247-09-015. No test article was administered during this study and any therapy was at the discretion of the PI, with no restrictions.
745115|NCT00899847||
745116|NCT00899717||
745117|NCT00899678|The Participant Flow refers to the Safety Set (SS) population. The Safety Population includes all subjects enrolled who received at least 1 injection of study treatment.|"During an Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W). Subjects who showed a clinical response at Week 6 were randomized in a 1:1 ratio to one of 2 dose groups.
~Subjects who did not respond at Week 6 were withdrawn from the study."
745118|NCT00899600|The study was conducted over a two-year period (February 2007 to April 2009) at Dartmouth-Hitchcock Medical Center. Approval was obtained from the Committee for Protection of Human Subjects (Lebanon, NH, United States of America). Informed patient consent was obtained from all patients.|Three hundred and one patients were screened. Of these patients, 165 (55%) were eligible for enrollment. Sixty-one percent of eligible patients were randomized to one of the two treatment groups. No patients enrolled in the study were excluded from the primary analysis.
745119|NCT00899574|Ten patients were enrolled to this study between Nov. 2009 and Nov. 2010 at New York University Medical Center and affiliated hospital.|
745120|NCT00899548|Participants were recruited at each of the participating institutions at Johns Hopkins and within the Translational Breast Cancer Research Consortium.|
745121|NCT00899470||85 participants were enrolled and 24 were treated on study. 61 participants discontinued before randomization and treatment due to: no longer meeting study criteria (n=36), withdraw of consent (n=3), study was full (n=15), participant did not call for results (n=1), completed alternate status (n=5), or did not show for check-up (n=1)
745122|NCT00899431|Recruitment was from May 2009 to November 2012 for subjects with chronic lymphocytic leukemia (CLL) who had relapsed after failing conventional chemo-antibody combination therapy, or failed to achieve a Crwith frontline conventional chemo-antibody, or have 17p deletion, or in Richter's.|Patients were randomized at a 1:1 ratio to receive lenalidomide 90 to 100 days after allo SCT if they had persistent active CLL
745123|NCT00899392|Between October 2008 and March 2009, parents of 220 children scheduled for clinically indicated upper endoscopy were prospectively and consecutively contacted. 190 subjects verbally consented to be in the study and 148 subsequently participated. 6 were withdrawn from data secondary to entering disqualifying demographic response (not in data set)|30 subjects did not participate because they did not consent to participate. These were not enrolled in the study.
745124|NCT00899379|"Patients were recruited at 23 sites in the United States.
~First Patient Treated: April, 1995
~Last Patient Treated: January 1996"|Patients screened at a pretreatment visit were given allocated drug supply with instructions. If by 2 months after screening, a patient still had not treated a migraine attack with test medication, he/she was to be discontinued from the study.
745125|NCT00899353||
745126|NCT00898937||
745127|NCT00898807|Recruitment activities included chart review, telephone interviews and screens, discussion with physicians, and recruitment in the clinic waiting areas and assisted living facilities affiliated with the clinics. The recruitment period lasted from August 2009 to December 2012.|
745128|NCT00898677|"Patients were recruited at 47 sites in 21 countries in Canada, South America, Europe, Middle East, South Africa, and Australia
~First Patient Treated: September 1995
~Last Patient Treated: May 1996"|Outpatients screened at a pretreatment visit were given allocated drug supply with instructions. If patients had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled patients still had not treated an attack, they were discontinued from the study.
745129|NCT00898560||
745130|NCT00898443|Women in labor, admitted to UAB Labor & Delivery, who requested postpartum tubal ligation after delivery.|
745131|NCT00898222||
745132|NCT00897949|"Patients were recruited at 28 sites in the United States and 18 in 9 other countries.
~First Patient Treated: Mar 1995
~Last Patient Treated: Jan 1996."|Outpatients randomized at the prestudy visit were given study drug and administration instructions. If patients had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled patients still had not treated an attack, they were discontinued from the study
745133|NCT00897910|Subjects were recruited from the outpatient clinics or inpatient service of Karmanos Cancer Center by physicians in the Department of Hematology and Medical Oncology, between April 2008 and October 2009.|All 6 consented subjects had blood drawn during their routine labs. No bone marrow samples were collected.
745134|NCT00897897|Enrollment was initiated on March 19, 2009 and completed on April 24, 2010.|
745135|NCT00897715|This study was conducted at the VA Nashville between 01/2013 and 02/2015. Note that essentially the same study was also conducted at the University of Colorado (NCT01663103). Results were combined with Colorado for publication. However, the results reported here are only based on the subjects enrolled at the VA Nashville.|There is about a 2-week screening period between enrollment and assignment to a treatment group to access inclusion/exclusion criteria. Although 45 subjects were enrolled, only 15 subjects were assigned to a treatment group (30 subjects were screen failures).
745136|NCT00897676|Subjects age 6months to 18 years with congenital hyperinsulinism due to mutations in the Katp channel( KatpHI) were recruited from the Hyperinsulinism Center at The Children's Hospital of Philadelphia|17 subject were enrolled (consented). One(1) withdrawn
745137|NCT00897390||58 participants were enrolled in the study; 34 participants were not dosed (23 no longer met study criteria, 4 withdrew consent, and 7 for other reasons).
745138|NCT00897104|"Participants were recruited at 31 sites: 6 in UK, 9 in Norway, 2 in Switzerland, and 14 in Sweden
~First Participant Treated: August 1995
~Last Participant Treated: May 1996."|Participants screened at a pretreatment visit were given allocated drug supply with instructions. If participants had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled participants still had not treated an attack, they were discontinued from the study.
745139|NCT00896779||
745140|NCT00896649|193 participants were enrolled onto this study between 4/8/2009 through 5/31/2012 in the Breast Center.|
745141|NCT00896532|This study was conducted at 29 centers in 7 countries in Europe, North America, and Argentina. Participants were enrolled from the 3rd of June 2009 to the 17th of February 2010.|A total of 807 patients were screened and 419 were randomized. The study included a 24-month treatment phase, followed by rerandomization to a 12-month extension phase with denosumab or placebo; followed by a 12-month retreatment phase with romosozumab, followed by a 24-month follow-on phase with zoledronic acid or no intervention.
745142|NCT00896480||During the screening the following steps occurred: check for inclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
745143|NCT00896454|First patient was enrolled on 16 November 2009 and the last patient enrolled on 02 July 2012. Data are reported as of the primary analysis cut-off date of 13 September 2012.|
745144|NCT00896441||5 participants in the Healthy controls group withdrew consent prior to allocation to study arm.
745145|NCT00896389||
745146|NCT00896363|A total of 99 participants with major depressive disorder (MDD) were enrolled in this study. The study was conducted at sixteen centers in Russia from 23 April 2009 to 09 February 2010|
745147|NCT00896337|Enrollment of up to 133 subjects was planned; 125 subjects were enrolled at 28 centers in the United States from May 14, 2009 to December 14, 2010.|
745148|NCT00896298||
745149|NCT00896233||Part 2 of the study was not conducted; however, in Part 2 of the study, participants would have had a screening visit, followed ~1 month later by one imaging visit. The imaging visit would have consisted of two liver Magnetic Resonance Elastography (MRE) scans.
745150|NCT00896168||
745151|NCT00896064||
745193|NCT00894361|October 1, 2001 to January 1, 2007 recruitment period from the Minneapolis VAMC Orthopaedic Clinic|Patients that were recruited but not enrolled either failed the inclusion criteria or elected not to participate
745152|NCT00896051|Etravirine coadministered with 2 doses of atazanavir/low-dose ritonavir each combined with 1 nucleoside reverse transcriptase inhibitor was evaluated in human immunodeficiency virus - type 1 infected participants. The study was conducted between 25 June 2009 and 10 April 2012 and participants were recruited by 17 investigators in 4 countries.|Fifty (50) participants were enrolled in the study and received treatment with study drug during a 2-week Pre-treatment Period (Week -2 to Day -1) and a 48-week Treatment Period (Day 1 to Week 48). Efficacy data are reported for the 48-week Treatment Period.
745153|NCT00896038||
745154|NCT00896025||
745155|NCT00896012|Adult participants who received their first kidney transplant were eligible to participate. Recruitment occurred from January 2008 until October 2010.|Of the total 58 participants enrolled in the study, 6 participants were not randomized to either the Low Dose Tacrolimus or Rapamycin Conversion arm. Only those showing no evidence of subclinical rejection or borderline changes on 3-month protocol biopsy were eligible for randomization.
745156|NCT00895947|A total of 200 healthy volunteers were enrolled at the University of Western Australia in Perth between April 17 and July 31, 2009.|Two of 200 randomized subjects (one in each group) decided not to begin study treatment after enrollment, so only 198 subjects were evaluable for response.
745157|NCT00895934||
745158|NCT00895921||
745159|NCT00895895||
745160|NCT00895843||
745161|NCT00895830||
745162|NCT00895817|Subjects with symptoms of esophageal dysfunction were recruited from the GI clinic of Walter Reed Army Medical Center. Recruitment dates were from 2008-2010.|Subjects with a confirmed diagnosis of EE based on symptoms and tissue biopsies were offered enrollment.All subject underwent 24-hour pH studies to stratify GERD positive and GERD negative. A computer generated list of random numbers was then used to separate patients into two equal treatment groups (esomeprazole and fluticasone proprionate).
745163|NCT00895752||
745164|NCT00895661||
745165|NCT00895622||Two hundred forty-four patients registered for the first step registration which consisted of central pathology review confirmation of histology. One hundred seventy-eight continued on to the second step registration.
745166|NCT00895583||
745167|NCT00895531||
745168|NCT00895453||
745169|NCT00895414||
745170|NCT00895310|Recruitment took place at a single institution.|
745171|NCT00895284|All subjects were recruited at Mayo Clinic in Arizona.|
745172|NCT00895245|Patients with Head and neck cancer being treated with concurrent cisplatin and radiotherapy were approached for study participation.|
745173|NCT00895232|November 14, 2003 - August 8, 2005 Locations: Hospitals and Medical Clinics|A Baseline score > or = to 15 was required on the International RLS Study Group (IRLSSG) Rating Scale. At least 1 leg was required to have an average baseline Periodic Leg Movement (PLM) while asleep > or = to 15 movements per hour by actigraphy.
745174|NCT00895193|Initial screening occurred over the telephone. Subjects that met preliminary study criteria were scheduled for a screening visit. Recruitment was conducted at the University of Kansas Medical Center.|
745175|NCT00895180||The completers include those participants with progressive disease (PD) or those who died.
745176|NCT00895154|All participants are patients of the Pediatric Division of Hematology at Washington University School of Medicine and St. Louis University School of Medicine. Participants will be recruited during regularly scheduled clinic visits.|21 patients completed informed consent to participate in the study. 3 withdrew before the start of the study so they were never assigned to study arms.
745177|NCT00895037||
745178|NCT00895011|Subject recruitment occurred at US investigative sites between April 2009 and December 2010.|Subjects meeting the initial eligibility criteria completed a 4-week non-treatment run-in period during which information on each attempt at intercourse was recorded. At the end of the run-in, subjects meeting the randomization criteria were eligible for assignment to one of the treatment groups.
745179|NCT00894933||
745180|NCT00894803|The trial was conducted in emergency departments at 9 US medical centers comprised of 21 hospitals. Subjects were recruited between July 2009 and October 2012.|No enrolled participants were excluded from the trial before assignment to groups.
745181|NCT00894790||
745182|NCT00894738||
745183|NCT00894699|Study initiated 22 June 2009 and completed 11 September 2009. One clinical research center participated in the study|Patients were to be between 18 and 60 years of age, generally healthy, and who are expected to require more than 400 cc or less than 700 cc of abdominal fat removal during the procedure.
745184|NCT00894686||This study is a follow-up study of 700401 (NCT00161967) in which participants received the first booster vaccination.
745185|NCT00894647|Subjects were screened in 20 sites-16 in the United States of America (U.S.A.) and 4 in Canada. Screening began on 01 Jun 2009 and the last subject was enrolled on 03 Aug 2009.|Subjects had to have ≥10 AK lesions in an area the face to participate in the study. At screening, at least 5 visible lesions were not treated with cryosurgery, and 5 to 14 visible lesions were treated with cryosurgery. Subjects needed at least 5 AK lesions after the skin healed sufficiently from the cryosurgery to be eligible for randomization.
745186|NCT00894556|"Patients were recruited at 21 study centers in the United States.
~First Patient In: 10-Jun-2009;
~First Patient Treated: 26-Jun-2009
~Last Patient Last Visit: 12-Jan-2010;
~Last Patient Treated: 25-Dec-2009"|"Participants who met entry criteria but had evidence of suicidality or were severely depressed (based on
~questionnaire scores) were excluded. Within 2 months of entry, participants were to treat a moderate/
~severe migraine attack with sumatriptan 100 mg and were randomized if they still had moderate or severe
~pain at 2 hours post-dose."
745187|NCT00894543|Participants were recruited from July 2009 to June 2010. The trial was conducted at four MsFLASH network sites: University of Pennsylvania, Massachusetts General Hospital, Indiana University, Kaiser Permanente Division of Research in Oakland, California|Following enrollment (signing the consent), symptoms and health were reviewed, brief physical exam conducted and urine pregnancy test administered, daily hot flash diaries completed for one week (in addition to two weeks before enrollment).
745188|NCT00894517||
745189|NCT00894504||
745190|NCT00894465||
745191|NCT00894413||5 subjects were screen failures
745194|NCT00894322|Healthy participants were enrolled in Cohort 1 while participants with type 2 diabetes mellitus were enrolled in Cohort 2.|Enrolled participants in Cohort 1 were treated on Day 1 only. Enrolled participants who were in Cohort 2 were randomized to one of 2 treatment arms (exenatide or placebo) and were treated for 12 weeks.
745195|NCT00894244|The principal investigator will select patients presenting to the Dermatology Clinic at Northwestern Memorial Hospital who meet the inclusion criteria. These individuals will be referred to the trained researcher running the study. A brief, written description of the study will be given to the patient.|
745196|NCT00894166|Study started June 2009 and ended April 2011 and was conducted at Duke University Medical Center.|All enrollees began nicotine patches & those who didn't show a >50% reduction in expired air carbon monoxide (CO) at 1 week (1 week before the target quit date) or who lapsed in the 1st week after their quit date were randomized to one of 6 groups. The 7th group - Nicotine Replacement Therapy (NRT) Responders were excluded from this randomization.
745197|NCT00894127|"Recruitment Period: March 2009 to February 2011
~Helen F. Graham Cancer Center Newark, DE Christiana Care Health System, Newark, DE Waterbury Pulmonary Associates, Waterbury, CT"|
745198|NCT00893997|Recruitment Period: 01/09/07 through 03/24/08. All participants recruited at UT MD Anderson Cancer Center.|Twelve patients were registered, two patients did not receive drug and were not included in the study group therefore ten patients were evaluable.
745199|NCT00893984||
745200|NCT00893971|Conducted at a single site in Australia from May 2009 through July 2009. Study participation was a maximum of 7 weeks.|Study evaluating a single administration of inhaled treatment (PT001, PT003, PT005 and PT001+PT005 delivered from separate inhalers as a loose combination).Each subject was randomized to 1 of 4 sequences. Each sequence included the four treatment groups.
745201|NCT00893789||
745202|NCT00893763|Subjects were enrolled from two large urban teaching medical centers (VCU Health System, Tampa General Hospital). Subjects were recruited in multiple clinical areas just prior to intubation, including critical care units, emergency departments, pre-operative areas, procedural areas, and medical-surgical units during rapid response or code calls.|
745203|NCT00893737|First Patient In 6/2/09 Last Patient In 7/17/09 Patients enrolled at 5 Headache Specialty clinics, 2 Primary Care practices, and 1 Neurological practice.|
745204|NCT00893464|Participants took part in the study at 7 investigative sites in the United States and Canada from 20 August 2009 to 23 October 2014. Out of a total of 31 participants who were enrolled, 30 participants received at least 1 dose of ixazomib.|Participants with historical diagnosis of lymphoma, for whom at least 2 previous chemotherapeutic regimens failed and no curative option existed enrolled in 1 of 8 treatment groups based on ixazomib's dose: 0.125 milligram per square meter (mg/m^2), 0.25 mg/m^2, 0.5 mg/m^2, 1 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2, 3.11 mg/m^2.
745205|NCT00893152||
745206|NCT00893113|Private Urology Practice, recruited patients from June 2009 through May 2012|Prior or current therapies of Alpha Blocker or PDE 5 inhibitor 2 weeks prior to randomization or investigational agents 30 days prior to randomization excluded them. 11 participants screen failed.
745207|NCT00893074||
745208|NCT00892957|Patients were enrolled at 24 clinical sites in the United States, beginning July 2009 and completing in October 2010|176 participants were enrolled. 32 were screen failures. 1 was withdrawn by investigator (study coordinator not available to collect data), 2 participants requested withdrawal, 1 participant died prior to screening and prior to receiving study treatment. Therefore, 140 of the 176 enrolled were randomized.
745209|NCT00892775||Out of the 501 enrolled participants, 3 were not administered any vaccine and hence were not considered as having started the study.
745210|NCT00892723|Enrollment in the study began in June 2009 and was completed in September 2010. All patients were enrolled in dermatological medical clinics.|
745211|NCT00892710||10 patients were enrolled/randomized, but never treated due to their reqeust, physician's request or if they were deemed ineligible. 4 of these patients were on the Pemetrexed/Bevacizumab arm and 6 were on the Pemetrexed/Bevacizumab/Carboplatin arm
745212|NCT00892697||
745213|NCT00892606||
745214|NCT00892437|Participants were enrolled and treated in 32 study centers in the United States. The first participant was screened on 04 May 2009, and the last study visit occurred on 15 January 2015.|137 participants were screened.
745215|NCT00892281|"Dates of recruitment period: First subject was enrolled on April 30, 2009 and the last subject enrolled was on July 31, 2009.
~Types of location: Investigative sites were located at academic institutions and private physician offices."|The wash-out period up to baseline was 4 months (systemic acne treatment); 4 wks (antibiotics); 3 months [intense pulsed light(IPL) treatment]. Subjects were assigned to the Oracea® as Monotherapy (Oracea® alone) or Oracea® as Add-on Therapy groups (Oracea®/Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides).
745216|NCT00892177||
745217|NCT00892151||One subject was withdrawn for non-compliance. The subject was a parent of a child with diabetes and the 17 year old child was performing the software evaluation instead of the parent. The protocol states that the subjects were to be 18 years and older. The subject was withdrawn from the study and the data was not used in the analysis.
745218|NCT00892099||
745219|NCT00892047|Participants were recruited at 3 Centers (University of Pittsburgh, Centre for Addiction and Mental Health in Toronto, Canada, and Washington University). The first participant was enrolled July 2009, last finished August 2014.|468 signed consent. 181 were randomized. Of these 181, 91 randomized to venlafaxine plus aripirazol and 90 to venlafaxine plus placebo. Prior to randomization, 191 responded to venlafaxine; 40 withdrew consent; 41 withdrawn by PI, possible AE, 14 non-compliance; 1 death.
745220|NCT00892008|Phase 4 nationwide post-marketing surveillance study conducted between Sep 2006 and Aug 2008.|
745221|NCT00891995||
745222|NCT00891982||
745223|NCT00891930|"This study was conducted at 14 centers in Belgium, France, Germany, Italy and Spain.
~A total of 100 patients were screened, of whom 76 were enrolled in Part 1 from 05 May 2009 to 27 June 2011."|Upon confirmation of eligibility participants were enrolled into Part 1 of the study to receive panitumumab plus irinotecan. Upon radiographically confirmed disease progression, eligible participants proceeded to Part 2 of the study to receive panitumumab plus ganitumab.
745224|NCT00891904||
745225|NCT00891878||
745226|NCT00891839||Forty-five patients were screened and all were enrolled.
745230|NCT00891657|Between November 10, 2008 and March 4, 2009, a total of 15 subjects were consented for potential participation, of whom all 15 subjects were randomized. There were no intra-operative screen failures.|
745231|NCT00891618|Recruitment Period: April 30, 2009 to March 28, 2013. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.|Of the 27 participants registered, six participants were registered but excluded before treatment from the study.
745232|NCT00891527||
745233|NCT00891462|Patient recruitment occurred from April to July of 2009 at 106 study sites, (100 in the United States and 6 additional sites in Canada.) A total of 99 study sites randomized patients.|From the total of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.
745234|NCT00891436|Subjects were recruited during the spring pollen season of 2009 at a large urban medcial center's allergy clinic.|There was no run in period. All 20 participants that enrolled in this study were included in the trial.
745235|NCT00891371|This was a multicentered study performed at 18 investigational sites in Belgium of which 11 recruited patients.|
745236|NCT00891319||
745237|NCT00891293||
745238|NCT00891228||
745239|NCT00891202|A total of 72 participants were screened between 5 November 2009 and 29 July 2011, of which 32 participants were screen failure. Overall 40 participants were enrolled and the study was conducted across 18 centers in 12 countries.|The 40 participants who met inclusion criteria received placebo or Genz-112638 (eliglustat tartrate) during 39 weeks primary analysis period (PAP). After Week 39 of the PAP, all participants who remained in the study received eliglustat tartrate in the long-term treatment period (LTTP) for up to Week 312.
745240|NCT00891176||At 3 years of age, 582 subjects were enrolled. One subject who did not participate in the primary study was enrolled by mistake and was therefore withdrawn from the study. Therefore the total number of subjects participating at the 36 months of age time point was 581.
745241|NCT00891046|The study was conducted at 61 centres in 20 countries.|A total of 147 participants from studies CACZ885G2301 (NCT number: NCT00889863) and CACZ885G2305 (NCT number: NCT00886769) and 123 canakinumab treatment- naive participants were enrolled into this extension study.
745242|NCT00891020||1129 patients were screened for the study. Of these 1129 patients, 886 patients were enrolled and 243 patients were screen failures.
745243|NCT00890981|The first subject enrolled on 14-JUL-2009. The last subject enrolled on 12-MAY-2010|
745244|NCT00890929||
745245|NCT00890916||Note that the data from the first three (of 10) participants was published in the Journal of Hand Surgery (2008; 33(4):539-50).
745246|NCT00890825|Selection of patients was in 2nd line patients with KRAS mutation positive locally advanced or metastatic NSCLC (Stage IIIB - IV).First patient enrolled: 20 April 2009.Last patient last visit: 30 June 2010.Data Cut Off (DCO): 01 May 2011|
745247|NCT00890721||
745248|NCT00890695|Recruitment was started on June 5 2009 and finished on October 8 2009. The study was terminated early because of an inadequate recruitment rate and because a donor-funded supplementary feeding programme targeting moderately malnourished children was started in September 2009.|Of the 7,132 sick children aged 6 months to 5 years seen in outpatients during the study period, 190 with a mid upper arm circumference (MUAC) <12.5cm were assessed for eligibility. Randomization was carried out on 65 children who were eligible and whose carers consented. 1 was withdrawn: weight for height Z score (WHZ) was found to be <-3.
745249|NCT00890682||
745250|NCT00890656|Recruitment Period: 6/9/2003 to 10/12/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.|
745251|NCT00890617||
745252|NCT00890591|The study pop. was defined by the inclusion criteria. This study was carried out in 14 centers in Brazil with inclusion 2 months after the first study subject, started in Aug 06. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. The last patient out was in Jul 07.|A wash out period was needed in case of a previous inefficient antihypertensive medication, so it was interrupted from 2 to 3 wks before the enrollment. The patient could be excluded considering the exclusion criteria.
745253|NCT00890552||
745254|NCT00890409|Dates of the recruitment period: May 2002 to August 2005; Types of location: Children's Hospital or Women and Children's Medical Centre.|
745255|NCT00890396|Subjects that were eligible for enrollment included all children who have completed at least 18 months of the BABY HUG Treatment Study.|Parents and the participants' health care providers, who had not yet been informed of the BABY HUG randomized treatment, selected open label hydroxyurea (HU) treatment or standard care (SC).
745256|NCT00890201|Patients recruited at the Department of Surgery of the Hospital de La Serena from January 2009 to July 2009|Patients submitted to elective cholecystectomy for symptomatic gallstone disease, older than 16 years of age and patients submitted to elective gastrectomy for gastric cancer harboring normal gallbladders (without gallstones), were included in this trial. Patients within any other clinical situation were excluded
745257|NCT00890162||
745258|NCT00890097|Subjects were recruited from 48 study centers located in 14 countries.|This reporting group includes all enrolled subjects (772). A subject was considered enrolled if they met all of the inclusion criteria and none of the exclusion criteria.
745259|NCT00890084|April 1st 2009 to January 1st 2010 recruited in 90.5% General Practitioners (GP's) and 9.5% Specialists (Sp's)|45 patients excluded for inclusion/exclusion criteria
745260|NCT00889928||
745261|NCT00889915|Recruitment period was April to October 2009. Recruitment occurred at Child and Adolescent Psychiatry clinics in the USA.|
745262|NCT00889863||
745263|NCT00889824|Participants were recruited from 7/10/2009 through 6/30/2012 from Dr. Goebel's clinical practice.|There was no run-in or washout. All participants received the intervention.
745264|NCT00889720||
745265|NCT00889707||Targeted patient enrollment was 90. 92 patients were actually randomized and dosed before enrollment was discontinued.
745266|NCT00889681|Investigators at ten (10) sites enrolled a total of 81 study subjects between March 31, 2009 and January 24, 2011. The first subject was cryoablated on April 3, 2009.|There were three (3) subjects who were early exits in the study, two for not meeting qualification criteria and one for insurance disapproval.
745271|NCT00889265|Recruitment was from June 2009 to February 2011. Subjects were recruited from patients attenting the PI's clinic and had one edentulous site which required lateral ridge augmentation prior to dental implant placement.|All enrolled participants took part in the study.
745272|NCT00889252||
745273|NCT00889226||
745274|NCT00889200|"Subjects were recruited from the community via flyers and through Internet and newspaper advertisements for healthy adults experiencing problems with sleep. Voluntary written informed consent was obtained for the study, which was approved by the Butler Hospital Institutional Review Board."|Excluded subjects met criteria for current major depressive disorder (MDD) or other major Axis I psychiatric or substance use disorders. Subjects reporting < 6 hours of sleep/night and with score > 10 on Insomnia Severity Index (ISI) qualified. General good health required on physical and neurological examinations and on laboratory studies.
745275|NCT00889187|Participants enrolled from Dec 2009 and Sep 2011.|
745276|NCT00889005||
745277|NCT00888979||
745278|NCT00888940||
745279|NCT00888927||
745280|NCT00888849||
745281|NCT00888654||
745282|NCT00888628||
745283|NCT00888615||
745284|NCT00888511|July 2007 - November 2013|
745285|NCT00888459|The first person was pre-screened on 05/20/08 and the last person was randomized on 09/29/08.|
745286|NCT00888433|190 patients screened as eligible for study inclusion between June 9, 2009 and January 15, 2010.|84 subjects excluded pre-randomization due to blood pressure value at baseline visit (n=36); ineligible anatomy (n=30); declined participation (n=10); and other exclusion criteria (n=8).
745287|NCT00888381||
745288|NCT00888355|Patients were recruited at 37 sites in the United States. Prime Therapy Period: May, 1992 to January1993|Patients could be randomized if sitting diastolic blood pressure (SiDBP) after 2 and 4 weeks of placebo washout was 95-115 mm Hg and the difference between measurements at the 2 visits did not differ by >7 mm Hg.
745289|NCT00888329|Enrollment began July 2007. Enrollment stopped October 2011 due to slow accrual.|
745290|NCT00888238|"Subjects were recruited at Veeda Clinical Research Pvt. Ltd. in May 2009.
~First Patient Screened: 20-May-2009.
~Last Patient, Last Visit: 21-Jul-2009.
~1 site"|Subjects screened over a 1 week period.
745291|NCT00888173|The study was activated on 7/6/2009 and suspended to accrual on 12/14/2009. The study reopened on 9/7/2010 and closed on 1/3/2011.|
745292|NCT00888134||Participants 'complete' the treatment period if they ended their treatment for disease progression, unacceptable toxicity, withdrawal of consent, or intercurrent illness. Those participants who completed treatment then enter a follow-up period when they are followed until death or lost-to-follow-up.
745293|NCT00887978|The recruitment period for this study was June 2009 to July 2011. Sites were located in North America, Europe and Asia.|The 310 subjects who received a dose of study drug are presented here.
745294|NCT00887965|First subject enrolled on 02-JUN-09. Last subject enrolled on 28-APR-2010.|
745295|NCT00887926||Participant Flow is reporting enrolled participants who discontinued from the study. Participants who died or had progressive disease (PD) were considered to have completed the study.
745296|NCT00887913||
745297|NCT00887822||Study reported data up to clinical cut-off date 13 May 2011, as approximately half of the participants withdrew the study at clinical cut-off date. Ad hoc analysis was done for overall survival, with clinical cut-off date of 12 January 2012, subsequent to clinical cut-off date of 13 May 2011.
745298|NCT00887809||
745299|NCT00887744|The first patient entered the study on November 20, 2006 and the last patient's last visit was on May 21, 2009 with a total study duration of 30 months.|Not applicable. Single arm study
745300|NCT00887679|Anxiety disorders in HIV-infected patients from the general population|
745301|NCT00887653||
745302|NCT00887640||
745303|NCT00887588|A total of 308 participants were randomized to the core 12 week period, but 7 participants were excluded due to major Good Clinical Practice (GCP) violation. Of the 261 participants who completed the core, 252 participants entered the extension period.|Eight participants, who completed the core, could not continue in the extension because the 36 week protocol amendment was not yet approved by health authorities; 1 participant, who completed the core, discontinued before the extension start due to an adverse event.
745304|NCT00887575|Patients were recruited at multiple dose levels into the Dose Escalation (Phase I) portion of this study to determine the safest dose of this regimen (MTD- Maximum Tolerated Dose). Upon determination of this dose, patients being treated at the MTD proceeded to the Dose Expansion (Phase II) portion of the study and additional patients were recruited|
745305|NCT00887562||
745306|NCT00887549||The trial consists of induction therapy (up to 4 cycles of pemetrexed-cisplatin treatment) and maintenance therapy (pemetrexed only). Only participants who do not develop disease progression during induction therapy are eligible to receive maintenance therapy.
745307|NCT00887510|Patients were enrolled from the University of Florida Shands healthcare system between May 2007 and June 2009.|24 participants recruited; 24 randomized, 61 excluded (61 did not meet inclusion criteria)
745308|NCT00887484|Clinical research center|
745309|NCT00887471|Review of surgical case logs identified 45 patients with positive polysomnography (PSG) (laboratory-based, home or nap)who had undergone PITA and 101 with positive PSG who had undergone T&A.|Of these 15 PITA patients entered and completed the study and 15 matched T&A patients entered and completed the study.
745310|NCT00887458||
745311|NCT00887354||Full Analysis Set (FAS) is defined as all randomized participants receiving at least one dose of study drug with at least one post-baseline efficacy measure.
745312|NCT00887341||
745313|NCT00887315|Funding was withdrawn before conclusions were reached so the study was terminated.|
745314|NCT00887289||
745315|NCT00887250|Patients were recruited at 22 sites in the United States. Prime Therapy Period: December, 1991 to August, 1992.|Patients could be randomized after the 4-week placebo baseline period if their mean sitting diastolic blood pressure (SiDBP) was 95-115 mm Hg and ≤7 mm Hg from the mean SiDBP after 2 weeks of placebo therapy
745353|NCT00885352||Lab abnormalities (the reason for discontinuation cited below) included creatinine, creatinine clearance, and estimated glomerular filtration rate.
745316|NCT00887224||1072 participants were screened, 874 were enrolled into Desvenlafaxine succinate sustained release (DVS SR) open-label 8-week response phase; 659 entered into 12-week open label stability phase. After 20 weeks of open-label treatment 548 subjects were randomized to the 6-month double-blind phase to receive either placebo or to continue with DVS SR.
745317|NCT00887198||
745318|NCT00887159|Participants were recruited from ECOG member institutions between July, 16, 2009 and August 12, 2011.|
745319|NCT00887068|Recruitment was from September 2009 to April 2017 for high risk subjects with acute myelogenous leukemia (AML) and myelodysplastic (MDS) patients who have undergone an allogeneic transplant.|Patients were randomized to receive azacitidine (AZA) or standard of care 40 to 100 days after allo SCT.
745320|NCT00886938|Recruitment Period: 06/2009-08/2010 Subjects recruited from Washington University Clinics and from Washington University Volunteers for Health.|Screening for Motor Threshold with rTMS magnet resulted in screen failure for one subject. Screening for psych history with psychiatrist screen failed one subject. And another subject admitted to falsifying his information, he was withdrawn from the study during screening.
745321|NCT00886899||
745322|NCT00886834|Patients were recruited from July 2009 to November 2010. All IUD insertions occurred at the University of Utah Ob/Gyn clinic.|Participants had an initial study visit where the consent was signed and they were given misoprostol or placebo to take at home. Participants and providers were blinded to the treatment group.
745323|NCT00886821||Study consist of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately.
745324|NCT00886795||
745325|NCT00886769||
745326|NCT00886743||A total of 45 participants were screened; of these, 19 received treatment.
745327|NCT00886704|190 subjects were screened and gave informed consent, and 50 were enrolled.|The main reason for screen failure (about 95 %) was an omega-3 index < 5.0%. Additional subjects were excluded because of the lack of any evidence for atherosclerotic disease, hospitalisation or lactose intolerance.
745328|NCT00886691|150 patients were enrolled into this trial. The study opened to accrual December 2010 and closed to patient entry August 2012.|
745329|NCT00886639|inpatient rehabilitation programme, recruitment directly after admission.|
745330|NCT00886626|Recruitment occurred from October 2009 - August 2010; participants were recruited from medical clinics in the Minneapolis-St. Paul area.|29 patients qualified for the study and were approached about participation. 12 agreed to participate.
745331|NCT00886613|The study was performed in 2 parts - Part A and Part B, with a total of 120 participants.|In Part A, 42 participants received a baseline VZV Skin Test which was evaluated 48 and 72 post administration, and these participants were included in the analysis for Part B. All Participants were randomized to receive V212, Zostavax™ or placebo.
745332|NCT00886600|Patients were recruited at 9 sites in the United States. Prime Therapy Period: May, 1991 to March, 1992.|Patients could be randomized if sitting diastolic blood pressure (SiDBP) after 2 and 4 weeks of placebo washout was 95-115 mm Hg and the difference between measurements at the 2 visits was ≤7 mm Hg. At the end of placebo baseline the mean 24-hr DBP using ambulatory blood pressure monitoring (ABPM) had to be at least 85 mm Hg.
745333|NCT00886587||
745334|NCT00886483|Dates of recruitment: August 2008 to December 2009. Location: Nisonger Center, OSU Medical Center|Exclusion criteria: IQ <80, mental age <6, comorbid disorder or a medical disorder requiring medication that had psychoactive effects, >5 previous NF treatments, antipsychotic medication within 6 mths pre-baseline, fluoxetine/atomoxetine 4-wks pre-baseline, stimulant 1-wk pre-baseline, or any other psychotropic medication 2-wks pre-baseline.
745335|NCT00886340||
745336|NCT00886288||163 patients without information on albuminuria at baseline were enrolled to the study in addition. However, for these patients information on study completion is not available.
745337|NCT00886262||
745338|NCT00886236||
745339|NCT00886145||
745340|NCT00886119||Two participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
745341|NCT00886015|Community-level eye screenings were conducted to identify all trichiasis cases in the community. Patients were scheduled for surgery. On the day of surgery they were invited to join the study if they were eligible.|"963 individuals assigned to Trachomatous Trichiasis (TT) clamp, 6 did not participate. 3 refused surgery, 2 ineligible because of lower eyelid trichiasis only, 1 participant did not present for surgery.
~964 individuals assigned to Standard, 4 did not participate. 2 refused surgery, 2 ineligible because of lower eyelid trichiasis only."
745342|NCT00885846|Participant recruitment for cohort 1: August 2007. Participant recruitment for cohort 2: February 2008. Place of recruitment: Bastyr University Research Institute.|The second cohort was necessary to achieve desired sample size.
745343|NCT00885768|all patients recruited during 4 months from April 2008 through July 2008 in Tehran Heart Center.|
745344|NCT00885755||
745345|NCT00885742||
745346|NCT00885703|The study opened on February 19, 2010. The first participant enrolled on April 16, 2010. Stage 1 closed on September 5, 2013. A5225 Stage 2 opened on September 15, 2014 and the first participant enrolled on February 2, 2015. Stage 2 closed on August 19, 2016. Ten sites enrolled participants (1 domestic, 9 international).|
745347|NCT00885677|918 patients have been enrolled in the study, from 29/05/2009 (date of first enrollment) until 20/08/2014 (date of last enrollment).|918 subjects signed the Informed Consent Form. One of those subjects withdraw from the study prior randomization, therefore 917 subjects were randomized either to Study (462) or to Control (455) groups.
745348|NCT00885638|Recruitment was performed during 2011 to Lund University|
745349|NCT00885534||
745350|NCT00885482||
745351|NCT00885378|Participants at 43 sites in 4 countries (25 sites in the United States [US], 9 in Germany, 5 in Hungary, and 4 in Puerto Rico) received study medication and participated in this study.|Of the 166 subjects who entered the lead-in period, 6 discontinued: 3 withdrawal of consent, 1 poor/noncompliance, 1 adverse event (AE; abdominal pain secondary to partial small bowel obstruction), and 1 elevated liver enzymes that did not meet study exclusion criteria but was discontinued by the investigator.
745352|NCT00885365||406 participants screened, 324 participants randomized
745354|NCT00885170|Participants were enrolled and treated in 40 study centers located in the United States, Europe, South Africa, and Asia-Pacific.|Women ≥ 60 years of age who had been on, or were on, an alendronate therapy for postmenopausal osteoporosis were eligible to participate in this trial.
745355|NCT00885118||
745356|NCT00885105|Participants were enrolled from 17 October 2005 to 05 January 2006 at 7 medical centers in the US.|A total of 242 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
745357|NCT00885092|Participants were recruited from one US study center.|40 participants with normal eyes (other than vision correction) were enrolled in the trial. After the screening visit, participants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to Period 1. A similar washout occurred prior to Period 2. Cross-over study design.
745358|NCT00885079||
745359|NCT00884949||
745360|NCT00884910|Patients were recruited by the Netherlands Cancer Institute|
745361|NCT00884897||
745362|NCT00884832|This study was conducted between January 2009 and April 2012.|
745363|NCT00884806|Participants were recruited from 6 US study centers.|110 participants with normal eyes (other than vision correction) were enrolled in the study. After the screening visit, particpants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to the baseline/dispensing visit.
745364|NCT00884793||
745365|NCT00884754||
745366|NCT00884741||
745367|NCT00884611||
745368|NCT00884585||Per protocol defined pre-specified criteria, both eyes could qualify for treatment. However, only one eye was designated as the study eye.
745369|NCT00884390|Two hundred and eight (208) participants were enrolled into the study (146 participants into the ReFacto Switch group [Cohort 1: participants who switched from ReFacto to ReFacto AF] and 62 participants into the Other Switch group [Cohort 2: participants who switched from other Factor VIII (FVIII) products other than ReFacto to ReFacto AF]).|
745370|NCT00884377|Fifty Six subjects were recruited from the Infectious Disease Clinic at Walter Reed Army Medical Center from February 2004 to March 2009. At 2 months post-treatment, subjects assessed as having failed therapy were eligible for crossover to an alternate treatment.|
745371|NCT00884325|Subjects with uncomplicated atopic dermatitis were recruited form the PI's medical practice. Recruitment occurred from March 2009 through December 2009.|45 subjects were consented but 5 were screen failures.
745372|NCT00884312|This study was conducted at 23 centers in the United States and Canada from April 2009 to May 2017.|
745373|NCT00884286||
745374|NCT00884273|The participants were recruited by outpatient urologists. 180 participants were to be randomised in a 1:1 ratio to one of two treatment groups (90 participants were to be treated with degarelix; 90 participants were to be treated with goserelin plus bicalutamide). The recruitment period was August 2009 - December 2010.|The apparent skewed number of actual participants in the two groups is due to the fact that randomisation was done in blocks per site rather than per study.
745375|NCT00884221|The participants were recruited among the patients attending the clinics included in the trial.|810 participants were screened and 754 were randomised. 749 participants were exposed to highly purified menotrophin or recombinant FSH
745376|NCT00884117||
745377|NCT00884065|The study participants were recruited from two public services of primary health care of the Spanish National Health Service, one in Cornellà de Llobregat (Barcelona), the other in Ponteareas (Pontevedra), from June 2007 to January 2008.|
745378|NCT00884052|Recruitment over 2 years from neonatal intensive care units|
745379|NCT00884039||
745380|NCT00883779||
745381|NCT00883753||Patients participated in the 24 Week Core Study: MA21573 [NCT00750880] then continued to receive tocilizumab in this extension study for total treatment time of up to 104 weeks + a 4 week follow-up.
745382|NCT00883740||
745383|NCT00883688|Recruitment Period: July 23, 2009 to April 3, 2013. All recruitment done in medical clinics.|
745384|NCT00883675|Enrollment of patients took place at a single center in the United States (Dartmouth-Hitchcock Norris Cotton Cancer Center) and at ten sites in China that were early members of the China Clinical Trials Consortium.|
745385|NCT00883558||
745386|NCT00883493|First Subject in (FSI): 22 Apr 2009, Last Subject Last Visit (LSLV): 01 Mar 2011, in 9 countries, 29 Psychiatry centres, 421 randomised participants|An enrollment period of up to 7 days and if applicable a wash-out period for 7-28 days depending on the medication being used, ie. antidepressants, antipsychotics and/or mood stabilizers.
745387|NCT00883415||
745388|NCT00883389|Medical records of renal patients screened for eligibility upon arrival of their clinic appointment. Patients meeting study criteria approached at the end of their appointment regarding their interest in participating|All recruited participants assigned to receive intervention (medical alert accessory)
745389|NCT00883337|"The recruitment initiated in April 2009 was completed in July 2010. A total of 369 participants were screened at 54 sites in 13 countries.
~The common end date of core treatment period was 14 September 2011 (maximum treatment duration of 115 weeks).
~The end date of extension was 13 May 2015 (maximum treatment duration of 197 weeks)"|"Randomization was stratified by country and baseline disability (Expanded Disability Status Scale [EDSS] score ≤3.5 or >3.5).
~Assignment to groups was done centrally using an Interactive Voice Response System (IVRS] in a 1:1:1 ratio after confirmation of the selection criteria. 324 participants were randomized at 53 sites."
745390|NCT00883246|Subjects with all severities of peripheral arterial disease were recruited for this single-arm study. Outcome measures may apply to all subjects or be specific to level of disease severity (ie subjects w/claudication RCC1-3, subjects w/critical limb ischemia RCC4 (no wounds) or RCC5-6 (with wounds)). These are specified in the Arm/Group titles.|800 subjects were enrolled. One subject was excluded from all data analyses due to an invalid informed consent and was not considered started.
745391|NCT00883233|Recruitment period: 23 APR 2009 to 09 SEP 2009 in three private practice Canadian centres. Two centers used a central IRB, and the other used a local IRB.|
745425|NCT00881504|9 patients were recruited over the course of the study (2009-2011). All were recruited at Georgetown University Medical Center|
745426|NCT00881465||
745427|NCT00881361||
745428|NCT00881335|recuitment period: April 19th, May 17th location: Redsun geracomium|
745392|NCT00883181|A total of 1370 patients were enrolled at 87 sites in Europe, 5 sites in Canada, and 10 sites in Australia from December 2007 to October 2009. Of these, 1347 participants were included in the full analysis set (FAS) consisting of all enrolled patients who met protocol defined eligibility criteria and started at least 1 cycle of chemotherapy.|Eligible patients were enrolled sequentially. Upon completion of all planned chemotherapy cycles, or following cessation of chemotherapy for any reason, patients were followed-up annually for 5 years or until disease progression or death.
745393|NCT00883168||
745394|NCT00883129|Recruitment was carried out between September 28, 2009, and January 14, 2013, at 14 University Medical Centers within the United States.|
745395|NCT00883116||551 participants enrolled. 496 randomized (248 ixabepilone, 248 control); 487 received treatment (248 ixabepilone, 239 to control). Reasons not treated include 1 no longer met study criteria, 1 withdrew consent, 1 condition worsened, and 6 non-specified.
745396|NCT00883103||
745397|NCT00883090||One subject was not administered FXIII because of the Sponsor's decision. This subject was not included in the analyses.
745398|NCT00883051||
745399|NCT00882999||The study included 24 weeks of treatment and 24 weeks of follow-up. If necessary, participants had additional long-term follow-up for peripheral blood B cell monitoring (up to Week 108). Participants who completed study treatment (24 weeks) and the initial study follow-up (24 weeks) were considered study completers.
745400|NCT00882921||
745401|NCT00882908|The study was conducted at 79 sites in 13 countries: Australia, New Zealand, Canada, Austria, Belgium, Germany, Spain, France, Poland, Russia, Norway, Denmark, and the United States. Approximately 68% of participants were enrolled in Europe, 21% in North America, and 11% in Australia/New Zealand.|In total, 506 participants were screened; 388 participants were randomized of whom 386 participants started treatment. Two randomized participants did not start treatment due to withdrawal of consent.
745402|NCT00882778|Participating sites: Argentina (1), Canada (1), Croatia (1), Czech Republic (1), Germany (1), France (1), Ireland (1), Italy (4), Slovakia (1), Spain (3), Sweden (2), Switzerland (2), United Kingdom (1), and the United States of America (11)|
745403|NCT00882713|A total of 202 participants were enrolled in this study conducted from 12 February 2009 to 25 October 2010 at 28 study sites in Morocco.|Of 202 participants, 8 participants did not complete the stability verification period (SVP) of 4 weeks. Overall, 194 participants entered dose titration period (DTP) of 16 weeks.
745404|NCT00882687||
745405|NCT00882661||
745406|NCT00882583||A total of 22 patients were consented. One patient was a screen failure, one patient withdrew consent before initiating any treatment per protocol and patient was replaced in the run-in period before assignment to Cohort A.
745407|NCT00882557||Subjects evaluated for entry within 7 days prior to randomization, washout period of 7-14 days between doses, subjects began Day 1 on Friday of Monday/Wednesday/Friday or Saturday of Tuesday/Thursday/Saturday hemodialysis schedule
745408|NCT00882518||388 patients from 11 sites were randomised into Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) group or chlorpromazine group.
745409|NCT00882440|Patients were recruited at 28 sites in the United States. Primary Therapy Period: December, 1990-August, 1991|Patients could be randomized after the 4-week placebo baseline period if their mean supine diastolic blood pressure (SuDBP) was 100-115 mmHg and ≤7 mmHg from the mean SuDBP after 2 weeks of placebo therapy, or after a 2-week placebo baseline period if 2 sets of SuDBP data were within 100-115 mmHg, ≥3 days apart and differed by ≤7 mmHg.
745410|NCT00882362||
745411|NCT00882310||
745412|NCT00882206||
745413|NCT00882115|The enrollment period was 07/10/2009 - 11/09/2010. Enrollment took place in a private setting in the clinic located at the site.|Thirty-eight participants who tested positive for cat allergy were enrolled. The study had three phases: screen, control and intervention. There was a 2-week run in and a 4-week wash out period. Six subjects who did not respond to DEP challenge at screen phase, and three subjects who withdrew from the study before intervention were excluded.
745414|NCT00882102|Recruitment Period: 04/02/09 through 6/23/2010. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.|Of the forty-three participants registered only forty participants received treatment and were evaluable for toxicity and response.
745415|NCT00881959|Recruitment period was from 08 25 2009 to 04 24 2011. Subjects had a single non-adjacent Miller's class I or II gingival recession defect, greater than or equal to 2mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Subjects for this study were recruited from the PI's clinic.|Randomized
745416|NCT00881894|A total of 52, healthy, male subjects has been randomized in order to complete the trial with at least 44 subjects eligible for the Pharmacokinetic Set (PKS). Baseline characteristics refer to the PKS.|Patients with an insufficient patch adhesiveness were excluded from the PKS.
745417|NCT00881868|"Dates of recruitment period: First subject was enrolled on April 20, 2009 and the last subject was enrolled on November 17, 2009.
~Types of location: Investigative sites were located at private physician offices."|Wash-out period to baseline: 14 days: chemical hair process, steroid medication and/or ultraviolet B (UVB) treatment, calcipotriene, other vitamin D analogs, Anthralin/tar, all other anti-psoriasis medications; 4 wks: psoralen & UVA (PUVA) treatment & treatments other than biologics with possible efficacy on psoriasis; 12 wks: biological therapies
745418|NCT00881751||
745419|NCT00881712||
745420|NCT00881647||
745421|NCT00881621|Due to change of practice, it is difficult to complete the enrollment for the study|
745422|NCT00881608||
745423|NCT00881569|A total of 2 participants who met all inclusion and no exclusion criteria were enrolled in this extension study at 1 clinic site in the United States.|This extension study was designed to allow continuation of treatment in participants who demonstrated clinical benefit from previous treatment with CS-7017 in CS7017-A-U102 study.
745424|NCT00881530|This was an open label extension trial of the blinded 12-week dose-finding studies NCT00789035 and NCT00749190.|Patients from the preceding empagliflozin 10 and 25 mg groups continued to take the same doses. Patients on placebo and other empagliflozin doses were re-randomised to one of the empagliflozin treatments. Patients on metformin monotherapy or sitagliptin added-on to metformin in the preceding trials continued their open label treatments.
745429|NCT00881205||
745431|NCT00880919|This randomized, double-blind, placebo-controlled, dose comparison trial was conducted at three outpatient treatment centers from January 2010 to March 2013.|Ninety-five persons with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) borderline personality disorder (BPD) were randomly assigned to quetiapine XR 150 mg/day (n=33), quetiapine XR 300 mg/day (n=33), or placebo (n=29).
745432|NCT00880906||
745433|NCT00880893|Study participants were enrolled from 07 April 2009 to 08 October 2009 at 5 clinical sites in Singapore.|A total of 1198 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
745434|NCT00880763||Initial treatment period (Part 1) includes up through Week 6; Extension period (Part 2) includes from Week 6 through Week 96.
745435|NCT00880750||
745436|NCT00880698|Participants were recruited at five sites in four sub-saharan countries: Botswana (2), Tanzania, Zambia and Zimbabwe between December 2009 and October 2013.|Enrollment of infants 2 to < 15 weeks of age was stratified by HIV-1 infection and within the HIV-1 infected stratum, by CD4% (<15%, 15%-<20% and >=20%). Within stratum, participants were randomized with equal probability to receive three doses of RotaTeq or Placebo.
745437|NCT00880685||
745438|NCT00880620|First patient enrolled: 4/13/2009 Last patient out 10/05/2010|Following enrollment, subjects were randomized into one of the four treatment groups.
745439|NCT00880607|84 patients consented to participate. 3 patients did not start the study due to physician discretion.|
745440|NCT00880581||
745441|NCT00880568||
745442|NCT00880555||All individuals underwent baseline MRI, cognitive, and functional assessment. Four individuals (2 cognitive impairment- non dementia (CIND), 1 intoxicated, 1 with non-AD dementia) determined not to fit into one of the study arms (MCI, mild AD, or cognitively normal) were not asked to return for follow up cognitive and functional assessment.
745443|NCT00880542|Dates of recruitment period: 08/20/2008 - 07/19/2010 Types of location: Academic medical clinics|There are no pre-assignment details to describe
745444|NCT00880425||
745445|NCT00880399|This study was conducted at 20 centers across the United States of America (USA) (17 centers) and Canada (3 centers) from 04 March 2009 to 16 June 2010.|A total of 787 participants were screened for study eligibility, of which 331 participants were randomized. Out of 331 participants, 3 did not receive the study medication. All subjects population included all participants who had received at least one dose of the study medication and comprised of 328 participants.
745446|NCT00880360||
745447|NCT00880334|Patients enrolled from February 2007 through May 2010.|There were 7 cancelled patients who were randomized but did not receive treatment.
745448|NCT00880269|Participant flow is based on the full analysis set (FAS) which is the same as the safety set and includes one dose of the study drug.|Although this study did not complete stage 2, it is considered as a completed study because it follows Simon's optimal two-stage design in each stratum (predefined in the protocol), the study can stop due to futility at the end of Stage 1 and not be considered as a terminated study.
745449|NCT00880256|During a 17-month period, we enrolled 93 patients who were referred or self-referred themselves to the Mindfulness-Based Stress Reduction (MBSR) program at VA Puget Sound.|
745450|NCT00880230|Recruitment was for a period of 16 months. Subjects were recruited at medical clinics who participate in clinical trials.|
745451|NCT00880191|430 patients were enrolled on this study. There are 17 cancelled patients, 7 on the gabapentin arm and 10 on the placebo arm.|
745452|NCT00880165||
745453|NCT00880100|The enrollment started in April 2009 and was completed in November 2009. Cystic fibrosis (CF) patients with pancreatic insufficiency (PI), aged 2 to 6 years old inclusively, were enrolled from 14 CF centers located in United States of America.|
745454|NCT00880087||
745455|NCT00880048|The study was conducted at 31 centers across the North America (27 centers in United States of America and 4 centers in Canada) during the period 06 April 2009 to 21 June 2010. Total of 1604 participants were screened for study eligibility, of which 343 participants were randomized into the study.|A total of 339 participants were included in Intent-to-treat (ITT) population. ITT population comprised of all participants who gave informed consent, were randomized, received at least one dose of double blind medication and for whom at least one post-randomization assessment was available.
745456|NCT00880022||
745457|NCT00880009||Study was pre-maturely terminated after part 1 (safety lead-in phase) of the study and hence, the planned treatments of part 2, bosutinib + letrozole (Part 2) and letrozole (Part 2), were not administered.
745458|NCT00879996||
745459|NCT00879970|1332 participants were included in the TZD randomization, and 1221 of 1332 participants were included in the Vitamin D randomization.|Randomization occurred subsequent to a 3-week rosiglitazone (RSG) and vitamin D Single-blind Run-in Phase to assess compliance and tolerability. Participants received an RSG tablet (4 milligrams [mg]) and a vitamin D tablet (1000 international units [IU]) once a day.
745460|NCT00879879|Subjects recruited from SunCoast Community Clinical Oncology Program (CCOP) Research Base affiliated CCOP members located in the United States.|
745461|NCT00879814|Of the 189 participants who signed informed consent form, 134 were screen failures (mainly because of laboratory abnormalities) and 7 participants withdrew before the first vaccination. Total 48 participants were randomized into 4 groups.|
745462|NCT00879775|42 participants were screened. 1 did not meet criteria.|
745463|NCT00879710|Subjects were recruited by advertising in local news papers, Craig's list, local clinics between 2007 and 2012. Subjects were initially screened over the phone by using a telephone screening criteria (n=549). And eligible subjects (n=86) were brought to Translational Research Units (previously GCRC) for a screening visit of which 57 were enrolled.|"After screening visit, 23 patients with type 1 diabetes, and 34 patients with type 2 diabetes were enrolled.
~All the subjects were asked to stop their lipid lowering medications for 4 weeks. All the subjects who were enrolled started the study."
745498|NCT00877487||Subjects had been on stable treatment with commercial SPD489 (30, 50, or 70 mg/day) for at least 6 months. They then entered a 3-week open-label treatment phase on SPD489 (30, 50, or 70 mg/day). They then entered a 6-week double-blind randomized withdrawal phase where they were assigned to either SPD489 or placebo treatment group.
749758|NCT00671658|Recruitment Period: 11/02/2002 to 8/28/2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
745464|NCT00879697|From July 2005 to December 2006, three hundred patients with peripheral arterial disease, who were enrolled in a tertiary center specialized in vascular disease and were able to walk for at least 2 minutes (min) at 2 miles per hour (mph), were invited to a meeting at which explanations about this study were given.|Seven patients did not present symptoms of claudication during the treadmill test, 5 presented electrocardiogram response suggestive of myocardial ischemia, 4 presented exercise tolerance limited by other factors than claudication, and 2 presented poorly controlled blood pressure. All these patients were not included in the study.
745465|NCT00879684||
745466|NCT00879658|The study was performed in 297 patients at 73 centers in 12 countries.|One patient was misrandomized and never received study drug. Patient was included in Participant Flow and Baseline Characteristics but not included in actual enrollment count or Full Analysis Set..
745467|NCT00879645||
745468|NCT00879619|Study start date: July 2009 Primary completion date: October 2011 Study completion date: November 2011|
745469|NCT00879411||
745470|NCT00879398|Participants were enrolled between November 2009 and August 2014 from 235 Korean medical care centers.|
745471|NCT00879359||
745472|NCT00879333||
745473|NCT00879255|This study included 13 group cohorts plus 1 pilot group cohort. Not counting the cohort 1 pilot, approximately 246 combat Reservists, National Guardsmen, or Veterans from multiple VA Pacific Island Health Care System clinical sites were assessed for eligibility, and 125 were subsequently randomized into treatment groups.|Not counting the cohort 1 pilot group, approximately 246 combat Reservists, National Guardsmen, or Veterans received a comprehensive assessment at baseline to determine eligibility. 144 met inclusion criteria, 19 declined participation, for 125 ITT who were randomized into treatment groups.
745474|NCT00879229|Subjects were enrolled in a total of 29 study sites in Australia, Europe, and North America. The first participant was screened on 21 October 2009. The last participant observation was on 22 February 2011.|96 participants were screened; 40 participants were randomized and treated, and comprise the Safety Analysis Set and the Full Analysis Set.
745475|NCT00879190||
745476|NCT00879034|4 patients with classic HGPS from the United States were enrolled in March 2009 at Boston Children's Hospital. 1 additional patient had nonclassic mutations.|All patients screened to participate in study were consented onto the study as planned.
745477|NCT00878995|Subjects were recruited via UTMB Oncology, Radiation Oncology, and ENT clinics by study physicians.|Subjects began study before beginning chemotherapy and/or radiation therapy. 28 subjects enrolled total. 4 subjects withdrew before beginning the study.
745478|NCT00878969|This study was conducted at the Vanderbilt University Medical Center and at the University of Washington between January 2010 and June 2015.|"There is a 3-week period between enrollment and assignment to treatment group. This washout period is to ensure that no blood pressure medicines (ARBs or ACE inhibitors) are left in the body. Although 123 subjects were enrolled, only 78 were assigned to a treatment group (45 subjects were screen failures)."
745479|NCT00878878||
745480|NCT00878826|Subjects were enrolled from 11/2/09 to 1/13/11 in the Obstetric Clinic at Lucile Packard Children's Hospital.|There were no significant events.
745481|NCT00878800||
745482|NCT00878722||
745483|NCT00878709||
745484|NCT00878644||
745485|NCT00878605|Study recruitment commenced on June 1, 2009 under version 1.0 of the protocol, upon approval of the study by the IRB. The first participant was enrolled April 2010, and the last January 2013. Participants received either Cyclo-Z gel 3mg + 20mg zinc; Cyclo-Z gel 9 mg + 20mg zinc; Cyclo-Z gel 15mg + 20mg zinc or Placebo once daily for 12 weeks.|
745486|NCT00878553|A total of 394 potential patients were screened by 8 U.S. investigative sites for enrollment into this study. Of these potential patients, 327 failed to complete the screening process.|5 of the 67 patients who were enrolled and randomized into this crossover sleep study did not complete it. The reasons for discontinuation were withdrawal of consent (2 patients), automobile accident(1), family emergency (1) and lost to follow up(1). One additional patient withdrew after completing the sleep study but prior to the PK substudy.
745487|NCT00878501|International multi-center study, 41sites in North America, Japan and Europe recruited between March and July 2009. 327 participants enrolled into the study|Patients with past or ongoing intolerability to NSAID´s/COX-2's or paracetamol/acetaminophen or patients with insufficient pain relief from these treatments were included in the study. The WOMAC pain on walking had to be ≥40 mm and ≤90 mm on a Visual Analogue Scale (VAS) at both enrolment and after 1 weeks wash-out of medication (randomisation)
745488|NCT00878436|Members of the research team have attempted to contact the PI, unsuccessfully, and are unable to answer questions regarding results.|
745489|NCT00878228||
745490|NCT00878215|The study opened to participant enrollment on 10/24/2002 with the first participant enrolled on 12/27/2002 and the final participant was enrolled on 05/25/2011.|
745491|NCT00878189|This study originally planned to give PF-03084014 in combination with dexamethasone in participants with solid tumors and with T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma, including a drug-drug-interaction test of PF-03084014 and dexamethasone in solid tumor participants. But these parts were removed per protocol amendments.|
745492|NCT00877929||
745493|NCT00877890||
745494|NCT00877877|Subjects who participated in the primary study (NCT00196924) and received 3 doses of Cervarix.|Subjects enrolled in this study were primed with Cervarix vaccine as part of study NCT00196924. Subjects not returning for a specific visit were not withdrawn and could participate in the subsequent follow-up phases. Actual enrollment differed depending on the rate of return for the follow-up study, so not all subjects enrolled came to each visit.
745495|NCT00877799|Two cohorts of patients were enrolled in this study in sequential order. Based on interim analysis of the results for Cohort 1 where study drug was administered 24 hours following surgery, the protocol was revised to administer the study drug immediately following surgery when patients were more likely to report a higher level of pain.|
745496|NCT00877773|Recruitment Period: April 6, 2009 to March 28, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.|
745497|NCT00877604|Recruitment is started on eightth of october 2009, in medical clinics (Besta Institute in Milan, University II department of Neurology of Naples, University of Palermo department of Neurology).|34 patients enrolled, 5 of whom dropped out during the lead in phase.
745499|NCT00877448|Recruitment was done on a running basis after eligibility of inclusion/exclusion criteria was met and subjects were invited to clinic after screening procedures within up to 21 days before their first vaccination.|After meeting eligibility criteria to enter the study subjects were randomized simultaneously.
745500|NCT00877383||
745501|NCT00877370|Subjects were consented and enrolled between April 2009 and March 2011. All subjects were patients receiving care in an intensive care unit at University of Michigan Health System.|All patients that qualified for the study were approached. All subjects that gave their consent were enrolled.
745502|NCT00877071||
745503|NCT00877058||
745504|NCT00877032||From a given cohort, no more than 3 participants received treatment on Day 1, the remaining participants in the respective cohort received treatment at least 24 hours thereafter. All the remaining participants were treated on same day, if required, as per site scheduling.
745505|NCT00877006||A total of 568 participants were screened, and 121 were not randomized (2 due to adverse event, 14 withdrew consent, 68 did not meet inclusion criteria, 23 met exclusion criteria, and 14 for other reasons).
745506|NCT00876993||
745507|NCT00876928||
745508|NCT00876915|Participants screened for the study but deemed low or medium risk by Khorona scoring will be offered to consent to a one time baseline blood sample. These samples will be used as the control group to establish the value of TF as a predictive marker for VTE in ambulatory cancer patients as described in the Secondary Objectives.|Participants who undergo a baseline US/CT scan and are found to have a DVT/PE will be considered a screen failure and will not be randomized and continue on in the study. In addition, if any of the screening criteria are not met, these subjects will be considered screen failures.
745509|NCT00876733||
745510|NCT00876694||
745511|NCT00876460|43 patients entered.1 patient was replaced because he did not take any nintedanib(Nin) due to new brain metastasis after completion of first administration of docetaxel. Accordingly,42 patients treated with at least 1 dose of Nin in combination with docetaxel.Patients started mono therapy phase after discontinued from combination therapy phase .|In case a patient had to discontinue docetaxel for reasons other than progression disease, the patient could continue therapy with nintedanib if the patient had been treated with combination therapy with docetaxel during at least 4 treatment courses.
745512|NCT00876447|This was a long-term follow-up study that enrolled patients after participation in Study 191622-515 or 191622-516. A total of 397 patients were enrolled and 388 patients received at least 1 BOTOX treatment in study 191622-094 or in the preceding studies.|The protocol was amended to remove the 300 U dose. Patients ongoing in the study who were treated with 300 U BOTOX prior to the amendment were assigned to 200 U BOTOX for all subsequent treatments. Participant Flow and Baseline Characteristics are based on the first BOTOX dose that patients received.
745513|NCT00876395|"717 patients were planned to be randomized. A total of 719 patients were randomized between 10-Sep-2009 and 16-Dec-2012.
~Not completed reasons = primary reasons for end of treatment"|
745514|NCT00876343||
745515|NCT00876265|The subjects in this trial were enrolled from six study centers in the United States between November 2006 and July 2007. Subjects were males or non-pregnant females aged 18 to 75 years and who had bilateral nasolabial folds with a severity of 2 or 3 (moderate to severe).|The planned enrollment was 120 subjects; 118 subjects were randomized.
745516|NCT00876200||
745517|NCT00876018|Participants were recruited from three schools of Karnataka at a clinical site in Karnataka.|A total of 379 participants were screened. Out of which 300 participants were randomized.
745518|NCT00875979|There were 2 phases in the study, a Dose Escalation phase (Phase 1b) and a Dose Expansion phase (Phase 2a).|
745519|NCT00875836|Participants recruited between November 2009 and March 2014 primarily through media and internet advertisements.|
745520|NCT00875810||
745521|NCT00875797|Mechanically ventilated surgical and trauma critically-ill patients, older than 18 years, were enrolled in the study upon admission to ICU.|The patients with anuria or/and intestinal insufficiency (obstruction, discontinuation of intestine or severe paralytic ileus) were excluded from the study
745522|NCT00875706||
745523|NCT00875667|The study was conducted at 67 sites including 3 sites in Belgium, 3 in Czech Republic, 14 in France, 7 in Germany, 2 in Israel, 10 in Italy, 1 in the Netherlands, 5 in Poland, 11 in Russia, 4 in Spain, 2 in Sweden, and 5 in the United Kingdom (UK).|Participants were randomized in a 2:1 ratio to receive lenalidomide monotherapy or investigator's choice. Participants were stratified according to the time since diagnosis (< 3 years or ≥ 3 years), time since last treatment (< 6 months [refractory] or ≥ 6 months) and if they had undergone a prior stem cell transplant or not.
745524|NCT00875641|Subjects were identified through the automated corresponding health insurance plan databases, OptumInsight Life Sciences Research Database (from United Healthcare) and the HealthCore Integrated Research Database (HIRDSM) (part of Anthem, formerly known as WellPoint).|
745525|NCT00875615||
745526|NCT00875589||
745527|NCT00875563||
745528|NCT00875550||
745529|NCT00875524|Study participants were enrolled from 18 March 2009 to 01 July 2010 at 1 clinical center in Vietnam.|A total of 180 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
745530|NCT00875485||In this study, a total of 210 subjects were enrolled who participated at Year 11 (Y11) and Y12. There were a total of 8 additional subjects at Y13 and Y14 who came back from the primary study but did not participate in Y11 and Y12 as allowed by the protocol. One subject from the 210 subjects who participated in Y11 and Y12 did not return at Y15.
745531|NCT00875433||
745532|NCT00875420||
745533|NCT00875394|"Patients were recruited in Principal Investigator's private practice, in Mexico City.
~First Patient Entered: 15 Feb 2007. Last Patient's Last Visit: 27 Jun 2008"|"Patients 30 to 78 years of age with inadequate glycemic control (Glycosylated hemoglobin A1C (A1C) 6.5 to 11%) on diet/exercise and metformin dosed at ≥1500 mg per day patients were to receive either sitagliptin added to ongoing metformin or standard care added to ongoing metformin."
745534|NCT00875329||
745535|NCT00875277|Participants were treated with the investigational medicinal products for 4 weeks followed by a 10-day follow-up period.|
745567|NCT00873041||There was a 4 week screening period to determine eligibility prior to randomization.
745536|NCT00875212|"The subjects were dental students of the University. The recruitment locations were dental clinics of the faculty and laboratory facilities.
~The dates of recruitment included 2-3 months before starting the research in January 2006; and lasted for 2 months afterwards"|As a pre-assignment procedure, all volunteers signed an informed consent. The the volunteers received a dental hygiene kit containing a toothbrush and a fluoride-free and calcium-free dentifrice as part of the 1-week wash-out period prior to group assignment.
745537|NCT00875056||
745538|NCT00875017||Patients were randomized to one of 6 treatment sequences each of which consisted of four treatment periods separated by a 7-14 day washout period. In each of the first three treatment periods subjects received lanthanum carbonate 100mg +meal, sevelamer carbonate 2400mg+meal or meal. Subjects fasted in the fourth treatment period.
745539|NCT00874939|Eight participants were screened and four were enrolled in the study.|The study was terminated prior to randomization and treatment.
745540|NCT00874887||
745541|NCT00874848|"A randomized, Simon 2-stage flexible design with 22 patients enrolled in stage 1 and 68 additional patients in stage 2, for a total of 90 subjects (60 in the Imprime PGG arm and 30 in the Control arm) enrolled competitively across US and German clinical sites.
~First subject enrolled: 17 Aug 2009 Last subject last visit: 15 Nov 2012"|A total of 90 participants enrolled, 88 participants received at least one dose of study treatment, and 2 participants did not receive any study treatment.
745542|NCT00874822||
745543|NCT00874770|The study was conducted at 14 sites in France and USA.|A total of 74 participants were enrolled, of which 48 were randomized to receive treatment and 26 were not randomized: 22 no longer met study criteria, 2 withdrew consent, 1 was lost to follow-up, and 1 due to other reasons.
745544|NCT00874731|A total of N=23 participants were enrolled in this study, conducted in 2 parts. Participants completing study Part 1 (Pt 1) had the option to continue to Part 2 (Pt 2).|Participants progressed through the study as a single group over 4 periods: 1) Pt 1, Day 1: Placebo; 2) Pt 1, Day 2: Ridaforolimus 100 mg; 3) washout period (≥5 days); and 4) Part 2: Ridaforolimus 40 mg.
745545|NCT00874614||
745546|NCT00874549|Participants were enrolled and treated from 10 October 2007 to 25 August 2008 at 6 US clinical centers.|A total of 216 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in the analyses.
745547|NCT00874510||
745548|NCT00874497|Of the 84 participants treated in the trial, 38 completed the trial and 10 participants were ongoing at the time the sponsor discontinued the trial.|Prior to randomization, each participant was in a 28- to 35-day screening period. Placebo was given for 14 days and a daily diary of symptom scores and actuations of albuterol/ipratropium bromide were collected.
745549|NCT00874432|Recruitment occurred between January 2009 and May 2009. Patients were told about this study from the nephrologist or study coordinator around the time of their usual kidney clinic visit. Controls were enrolled through a group on campus who connects volunteers with research studies.|There is limited data for this study, the PI is now in private practice and some raw data no longer exists to answer this outcome. We have done our due diligence to populate this record with data that remains.
745550|NCT00874276|Subjects were recruited from a list of individuals who had already been genotyped. Subjects were called on the telephone to see if they wanted to participate in this study.|21 subjects were consented to the study; however, 7 were excluded before being assigned to a group for the following reasons: works at night, on contraindicated medication, history of mitral valve prolapse, obesity, started smoking, and elevated liver enzymes.
745551|NCT00874250||
745552|NCT00874237|132 subjects were screened.|"Of the 132 subjects who were screened for the study, 69 did not meet criteria, 5 withdrew consent, 1 no show, 9 enrollment full.
~48 (36.4%) were randomized and received at least 1 dose of study medication, and 46 completed the study"
745553|NCT00874120||
745554|NCT00874094|Patients with moderate to severe nasolabial folds were included.|Any patient who refused to attend all scheduled follow up visits were to be excluded.
745555|NCT00874029|Recruitment began in February 2009 with enrollment of the last patient in February 2011. All subjects were enrolled at nine clinical sites throughout the United States and two clinical sites in Latin America.|Subjects were excluded for the following: radiologic evidence by MRI of adenomyosis (n = 127), pedunculated subserosal or intracavitary myomas (n = 43), a history of pelvic malignancy, cervical dysplasia, a prior procedure to treat or remove myomas (n = 22), and contraindications to anesthesia or abdominal surgery (n = 12).
745556|NCT00873912|A total of 300 subjects were randomized into the study between 26May2009 and 27May2009 at 3 sites in the USA.|Each site enrolled and randomized 80 subjects in the monovalent vaccine group and 20 subjects in the placebo group
745557|NCT00873873|The NHLBI Childhood Asthma Management Program (CAMP) and CAMP Continuation Studies afforded a unique opportunity to investigate four newly described, distinct patterns of airway obstruction associated with childhood asthma, including two that have been associated with significant and potentially irreversible loss in pulmonary function.|Analysis of serial pulmonary function measures in participants in CAMP and CAMPCS over time showed 4 patterns of airway obstruction developing during childhood and adolescence based on measurements of pre-bronchodilator FEV1/FVC at the time of enrollment in CAMP and again at the end of the observational phase.
745558|NCT00873860|A total of 357 participants were screened in this study, out of which 194 participants me the eligibility criteria and were enrolled and randomized into the study.|
745559|NCT00873821||
745560|NCT00873782||
745561|NCT00873730|Patients were recruited in Spain from December 2006 to February 2008.|Patients were screened up to 6 weeks.
745562|NCT00873457|All patients were recruited from Duke University Medical Center between 8/2009 and 7/2011|One patient was a screen failure and did not go on to participate in the study.
745563|NCT00873366|Ninety one women and one man were enrolled between May 2009 and September 2011.|Six women withdrew consent prior to the start of testing. Another 9 participants were excluded from the analysis cohort due to: non-adherence to tamoxifen (N=2), use of a CYP2D6 inhibitor (N=1) and lack of sufficient samples for ¹³Cdextromethorphan analysis (N=6).
745564|NCT00873327|Infants recruited from intensive care nurseries.First subject was recruited/enrolled on 1/29/2010. Last subject was enrolled on 7/29/2010. A total of 32 subjects were enrolled at 4 participant sites.|
745565|NCT00873119||
745566|NCT00873093||
745568|NCT00873015|Patients admitted to University of Virginia Medical Center for the treatment of subarachnoid hemorrhage were screened for possible recruitment into this study.|Patients underwent neurosurgical repair of their subarachnoid hemorrhage prior to study recruitment and assignment.
745569|NCT00872989||
745570|NCT00872898|Patients for Part One of the study were recruited during a 15 month period from April of 2009, to June of 2010. Patients for Part Two of the study were recruited for a 37 month period from April of 2009 to April of 2012. All study sites were located in the United States.|Part One of the study enrolled 4 patients to determine a safe dosing regimen for Part Two. One patient from Part One of the study also enrolled in Part Two. The 121 patients enrolled in Part Two were randomized after two weeks of single-blind placebo treatment.
745571|NCT00872833||
745572|NCT00872729||
745573|NCT00872599|After providing informed consent, subjects underwent a history and physical examination, screening electrocardiogram and laboratory assessment. Subjects were excluded if they did not meet inclusion and exclusion criteria.|All anti-hypertensive medications were discontinued for 3 weeks. Participants who met blood pressure safety criteria were discontinued. Remaining participants underwent a 6-day low salt diet period and study day prior to randomization. Thirty-three of 75 enrolled met inclusion criteria, and were not withdrawn for high blood pressure during washout.
745574|NCT00872534||
745575|NCT00872521|The participants were enrolled at multiple sites in Australia|107 participants were enrolled and they all received the study treatment.
745576|NCT00872430|Patients recruited by the Clinical Research Unit from output clinic at Hospital de Clínicas de Porto Alegre through written announcements attached to panels inside the institution.|Twenty patients fulfilled elegibility criteria. No patients were excluded after signing informed consent form and randomization.
745577|NCT00872339||
745578|NCT00872170||
745579|NCT00872079||Participants were not enrolled into the randomized clinical trial for Aim 4 due to lack of funding.
745580|NCT00872027||
745581|NCT00872001||
745582|NCT00871975|Each site recruited in a Urology clinic setting. All patients were scheduled for Urodynamics testing. Sunnybrook recruitment period spanned Apr 2010 - Feb 2012. Vanderbilt Sept 2009 - May 24 2010. King's College May 2010 - August 2010.|There were no group assignments.
745583|NCT00871871||Enrolled participants were place into two periods. 36 Part I participants received Hydrochlorothiazide (HCTZ) first, then placebo or placebo first, then HCTZ. A new group of 28 Part II participants received Isosorbide Mononitrate (ISMN) first, then placebo or placebo first, then ISMN.
745584|NCT00871845||While the initial study design included a drug intervention, drug intervention was not done. The study team could not identify an adequate study population willing to undergo drug intervention and funding to cover the costs of the drug intervention. Therefore, the only intervention was weight loss instruction/management.
745585|NCT00871819||
745586|NCT00871780||
745587|NCT00871741||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
745588|NCT00871728||
745589|NCT00871715|Participants were recruited between 5 and 106 days post-stroke, predominantly during inpatient rehabilitation, from 7 sites in the United States metropolitan areas of Los Angeles, CA, Atlanta, GA and Washington, D.C.|From June 2009 through February 2013, 11,051 patients were pre-screened (medical record review) followed by 772 in-person screening assessments. Through both processes, 9,219 were excluded because they did not meet eligibility criteria; 645 declined and 826 were excluded for other reasons.
745590|NCT00871689|Study entry was open to patients aged 0 to 45 years regardless of gender or ethnic background at the University of Minnesota, Masonic Cancer Center.|
745591|NCT00871624||
745592|NCT00871572||
745593|NCT00871494||
745594|NCT00871429|Participants in this study will be patients seen at the Northwestern University SERIES clinic or Lurie Cancer Center who are receiving chemotherapeutic and or radiation treatments.|
745595|NCT00871403||Per protocol, the study had 2 treatment arms: Arm 1, investigational (pazopanib+pemetrexed); and Arm 2, standard of care (cisplatin+pemetrexed). Protocol amendment 1 lowered the pazopanib starting dose (SD) for new Arm 1 participants from 800 to 600 milligrams. For clarity, safety/demography data for these different SDs are presented separately.
745596|NCT00871377|Subjects were recruited from the local epilepsy society, and from flyers posted in the epilepsy clinic at UCLA, and from referrals within the UCLA Department of Neurology|
745597|NCT00871351||
745598|NCT00871338|A total of 284 subjects were enrolled in the study.|
745599|NCT00871286||
745600|NCT00871234|Recruitment occurred between April 2009 and March 2010. Participants were recruited via advertisements and word-of-mouth.|After participant enrollment, a screening visit was performed to determine eligibility. Participants may have been excluded from entering the study if they were found to be ineligible.
745601|NCT00871169|Subjects were recruited at the University of New Mexico Comprehensive Cancer Center between October, 2008, and December, 2014.|
745602|NCT00871143|"Recruitment: April 2009-March 2012. Single location: outpatient clinic at the Centre for Anxiety Disorders and Trauma at the Maudsley Hospital, London.
~Follow-ups: December 2009- September 2012. The trial ended when all participants had completed the follow-up.
~Last participant was recruited March 2012;last follow up was completed Sept 2012."|It was initially decided that 42 participants would be enrolled in the study (21 in each group), however in order to anticipate potential future drop outs, 46 participants were randomised into the 2 groups.
745603|NCT00871117||478 subjects were enrolled, but 2 subjects who received a subject number were not vaccinated. Therefore the total amount of subjects used for the analysis was 476.
745604|NCT00871000||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
745605|NCT00870896|10/14/08 to 2/5/09|Unable to recruit 20 participates study stopped at 5
745606|NCT00870870||
745607|NCT00870740||
745608|NCT00870727||
745696|NCT00866320|This is a multiple site study. Patients were recruited 2/2006-4/2008 from medical hospitals in Cleveland, Ohio and Dallas, Texas|
745609|NCT00870688||In total 82 patients were included in this trial. The patients were naive or changed from another antiepileptic or valproate preparation to valproate sustained release minitablets once daily in the evening.
745610|NCT00870584||
745611|NCT00870545|April 2009 - January 2010 and April 2010 - June 2010. There were 86 spouses enrolled in 14 groups. Spouses were recruited nationally through online methods such as websites and emails, mailings, and referrals from military, advocacy groups and veterans facilities. Twenty-six were referrals from the national Wounded Warrior Project office.|
745612|NCT00870467||
745613|NCT00870363||
745614|NCT00870233||
745615|NCT00870194||
745616|NCT00870103|64 patients were enrolled into the study|Nonrandomized
745617|NCT00869999|Patients were recruited in the lymphoma programs of the Massachusetts General Hospital Cancer Center, Dana-Farber Cancer Institute and Beth-Israel Deaconess Medical Center|
745618|NCT00869960||
745619|NCT00869947||
745620|NCT00869791|35 subjects were screened. 8 were screen failures (did to not meet inclusion/exclusion criteria) and 27 were randomized. Date of first patient enrolled: November 25, 2008 Date last patient completed: June 11, 2009 The study was conducted at 6 sites in the United States.|27 participants were enrolled, treated and completed the treatment with this protocol.
745621|NCT00869778|Participants were enrolled at 15 sites in the China. The first participant was screened on 26 March 2009. The last participant observation for the Week 76 analysis was on 09 October 2011|1218 participants were screened and 360 were randomized; 360 randomized participants received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
745622|NCT00869622|80 veterans with epilepsy who were treated with phenobarbital, phenytoin, carbamazepine and sodium valproate.|80 epileptic patients who have been on phenytoin, phenobarbital, carbamazepine or sodium divalproex for at least 2 years were enrolled.
745623|NCT00869609|The project was implemented in two settings: the first within an urban University campus and the second at a suburban YMCA. Recruitment commenced in May 2009 and was completed in July 2009.|
745624|NCT00869557|"Participants were enrolled in a total of 30 sites in the United States. The first participant was screened on 30 March 2009.
~Last participant visit:
~Primary endpoint analysis (Week 24): November 2009
~Week 48 analysis: April 2010
~Week 96 analysis: March 2011
~End of study: September 2013"|126 participants were screened; 71 were randomized (48 to the Stribild group and 23 to the Atripla group). All randomized participants received at least 1 dose of study medication and comprised the safety and intent-to-treat (ITT) analysis sets. No site enrolled more than 7% of participants.
745625|NCT00869518||
745626|NCT00869440||
745627|NCT00869414|This study was prematurely terminated because the P.I. is deceased. Although 16 participants were enrolled, however, the number of participants starting and completing the study as well as the number of participants assigned to each Arm/Group are unknown, since no data are available|
745628|NCT00869401||
745629|NCT00869375||
745630|NCT00869362|April, 2009 to May 2010, recruited from inpatient medical and surgical general care (non-ICU) inpatient units|
745631|NCT00869349||
745632|NCT00869323||
745633|NCT00869258||
745634|NCT00869206||
745635|NCT00869167||
745636|NCT00869141||
745637|NCT00869128|36 independently living patients who complained of insomnia and suffered from type 2 diabetes (16 treated with oral hypoglycemic agents and 20 on insulin) entered the study.|Patients with liver or renal disease (serum creatinine 1.5 mg/dL or higher) were excluded. All 36 patients were randomized and all concluded the crossover randomized and extension parts of the study.
745638|NCT00869089|Enrollment was open from September 2008 through 2009. Study visits were conducted in outpatient Dermatology clinic.|This was an open label single site study for adults with recalcitrant prurigo nodularis. Participants must have failed 4 weeks of treatment with topical corticosteroids or vitamin D derivatives.
745639|NCT00869050||
745640|NCT00869024||
745641|NCT00868998||
745642|NCT00868959||817 represents the total number of subjects who provided informed consent and enrolled, which is different from the total number of subjects who were treated with study drug, which was 813.
745643|NCT00868790||A total of 118 participants were randomized to one of 14 treatment sequence arms on this cross-over study. Each participant received 4 out of 5 treatments over 4 treatment periods. Before randomization, participants who had prior antihyperglycemic agent (AHA) treatment had a 4-week AHA wash-off, and all participants had a 2-week placebo run-in.
745644|NCT00868751||
745645|NCT00868712|Recruitment is complete. All patients were recruited from within the Walter Reed Anticoagulation Clinic, as specified in the protocol.|
745646|NCT00868699|4/29/09 to 2/1/12|
745647|NCT00868608||
745648|NCT00868530|Participants were recruited in China from September 2008 to December 2009.|
745649|NCT00868517|Letter, study flyers, and web sites were used to recruit Veterans to participate in this study at the Washington DC VA Medical Center. Veterans were recruited from November 2009 through June 2011.|Veterans who met initial telephone screening requirements were asked to participate in the full screening process. Of the 70 Veterans who provided informed consent, 35 Veterans were not randomized to study group because 1) did not meet full screening eligibility criteria; 2) did not complete baseline questionnaires; or 3) no longer eligible.
745650|NCT00868452|5/11/2009 - 1/9/2012|
745651|NCT00868439|120 subjects were randomized in Part 1 of the study (60 to each treatment group). Of these, 120 randomized subjects, 105 received either RLY5016 Powder for Suspension (n = 56) or placebo (n = 49).|Eligible participants ≥ 18 y/o, had history of chronic HF, clinically initiated spironolactone therapy, serum K+ = 4.3 - 5.1 mEq/L at screening and baseline, and either had 1) CKD, w/ eGFR < 60 mL/min and receiving HF therapies or 2) documented history of hyperkalemia led to discontinuation w/ aldosterone antagonist w/in 6 months prior to baseline.
745652|NCT00868374||
745742|NCT00863265||175 subjects were screened and 153 were excluded prior to randomization. 75 did not meet screening criteria, 39 declined to participate and 39 were not able to perform functions needed for the study. 22 Subjects were randomized and 21 completed the study.
745653|NCT00868348|A total of 361 patients were assessed for eligibility from May 2009 through March 2011; 62 patients participated in another study, 54 patients declined to participate, and 185 patients were excluded based on the exclusion criteria. Sixty patients (30 in each group)were enrolled, and data for the primary endpoint were registered in all patients|
745654|NCT00868309|Subjects arriving at participating centers with a pit viper bite were evaluated with respect to the inclusion/exclusion criteria.|
745655|NCT00868296|Patients were recruited worldwide March 2006 to February 2008.|Patients were eligible for enrollment into the study after completion of either study 3001B3-331 (NCT00362609) or study 3001B3-333 (NCT00259012).
745656|NCT00868231|This study was conducted at 2 sites in Germany. The first patient was screened in Mar 2009 and the last patient visit was in Jul 2009.|Eligible patients had at least a 5-day run-in period (and a maximum of 9 days) to assess patient's clinical stability.
745657|NCT00868218|Haukeland University hospital recrutiment in 2009|Haelthy person were randomly assigned to one of 4 vaccine groups
745658|NCT00868192|The study was open to participant enrollment on 05/28/2008 and closed to participant enrollment on 11/30/2010.|
745659|NCT00868166||
745660|NCT00868140||
745661|NCT00868101||
745662|NCT00867932|The recruitment period lasted from October 2009 to January 2011. Three sites in the United States of America enrolled a total of 7 participants with paroxysmal nocturnal hemoglobinuria (PNH).|Participants who completed this study could have continued treatment with commercially available eculizumab (Soliris®) and been followed in the Soliris® PNH Registry. Those who didn't complete the study or who didn't continue with Soliris® treatment after the study were followed for 8 weeks and monitored for signs and symptoms of serious hemolysis.
745663|NCT00867815|The study started on 13 JUL 2009 (FPFV) and the date of last visit was 29 DEC 2017 (LPLV).|There were 10 screening failures. The primary reasons for screen failure are protocol violation (8 participants) and consent withdrawn (2 participants)
745664|NCT00867659|Fertility practice. 20 oocyte donors completed the study bettwen 2009 and 2011|Long acting Cetrotide acetate was used in an attempt to prevent ovarian hyperstimulation syndrome.
745665|NCT00867568||
745666|NCT00867529||
745667|NCT00867503||
745668|NCT00867490||
745669|NCT00867451|Subjects were recruited from the community and families seeking services at the ADHD Clinic and in the Division of Developmental and Behavioral Pediatrics at Cincinnati Childrens Hospital Medical Center.|
745670|NCT00867360||
745671|NCT00867334|Patients were enrolled at community hospital.|Inclusion and exclusion criteria for the study were rigid, with only 10 patients of 39 screens being able to enroll. Of these 10 patients, 3 were subsequent withdraws occurring after enrollment of various reasons, thus did not wish to continue to participate in the study.
745672|NCT00867321||
745673|NCT00867308||2 participants on the 15mg arm and 3 participants on the 50mg arm were screen failures.
745674|NCT00867217||
745675|NCT00867165||
745676|NCT00867139|Patients were recruited from subjects who had a hematopoietic cell transplantation (HCT) within 2 years or combination chemotherapy within 3 months, those with chronic graft-versus-host disease (GVHD) requiring systemic treatment after 2 years post HCT, or with GVHD taking at least 2 immunosuppressive drugs between February - September, 2009|
745677|NCT00867113||Total of 113 subjects were screened and 91 were enrolled..
745678|NCT00867100||
745679|NCT00867087||
745680|NCT00867035|Screening in dental clinic March 2008-March 2009. With organoleptic(OLT)score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S), subjects invited to enter clinical trial. Subjects numbered in sequence from a computer-generated table of random numbers.|Exclusions: 1)Inability to return for evaluation, 2)inability to follow directions, 3) afflicted with systemic disease involving volatile sulfur compounds (VSC), 4)currently taking antibiotics, 5) using medicine in syrup form, 6) advanced periodontal disease, 7) smoker.
745681|NCT00867009||
745682|NCT00866918||
745683|NCT00866905||
745684|NCT00866879||"Donor participants were no part of our outcome analysis because their participation was only on the basis of providing blood for testing the immune system of the recipients.
~The analysis of the recipients was intention to treat therefore all recipient participants completed the study period"
745685|NCT00866814|From March 2009 through May 2010, a total of 119 patients were enrolled at 7 study centers in the United States.|
745686|NCT00866788||
745687|NCT00866775||
745688|NCT00866749|Recruitment Period: October 2006 - March 2014|
745689|NCT00866723||
745690|NCT00866697||
745691|NCT00866658|The study was conducted at 57 centers in 4 countries between March 10, 2009 and June 23, 2010.|A total of 437 patients were screened of which 126 (28.8%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 311 patients were randomized.
745692|NCT00866619|The study included 3 phases, a primary (PRI) phase (Months 0-3) and a booster (BST) phase at Month 20, each followed by a related PRI/BST efficacy, immunogenicity and safety (EIS) follow-up (FU) phase, and an EIS extension, from Month 32 to the median of Month 48 or Month 38 time point.|Screening included the following: check for inclusion/exclusion criteria, vaccination contraindications/precautions, subjects' medical history and signing informed consent forms.
745693|NCT00866606|Participants were enrolled in six centers in China.|
745694|NCT00866359|The study was conducted at 3 study sites in Turkey and 3 sites in the United States. The first participant enrolled was enrolled on October 23, 2009 and the last participant enrolled was enrolled on May 08, 2012.|Eligible participants were randomized 1:1 to receive study drug (apremilast or placebo). Since the incidence and severity of Behçet's Disease differ between males and females, randomization was stratified by gender.
745695|NCT00866333|Participants took part in the study at 6 investigative sites in the United States from 13 April 2009 to 8 February 2013.|Participants with a diagnosis of Relapsed or Refractory Hodgkin's Lymphoma (HL) were enrolled into one of three entinostat dosing regimens based on the version of the protocol at their time of enrollment in the study.
745697|NCT00866307|Patients with newly diagnosed high-risk B-precursor acute lymphoblastic leukemia (ALL), no prior cytotoxic chemotherapy besides steroids and intrathecal cytarabine and WBC criteria: Age 1.00-9.99 years: WBC >= 50,000/uL; Age 10.00 - 30.99 years or prior steroid therapy or with testicular leukemia: Any WBC|Patients with Day 29 Marrow counts >25% (M3) or pegaspargase contraindication go off therapy before risk stratification.
745698|NCT00866294||Participants who had completed all the study procedures (up to the post-study examinations) were defined as per protocol completers.
745699|NCT00866281|The study was conducted at 8 centers in 5 countries.|A total of 22 participants were enrolled in the study.
745700|NCT00866177||
745701|NCT00866047|Enrollment period: Jun 2009 - May 2010|
745702|NCT00866034|Recruitment period: September 2009 - July 2011 Six hundred and seventeen women undergoing IVF or ICSI were recruited from the IVF outpatient clinics of 13 fertility centres.|None were excluded before assignment.
745703|NCT00865904||
745704|NCT00865709||
745705|NCT00865566||
745706|NCT00865514|The participants were recruited by a posted advertisement.|Two subjects were enrolled but did not participate in the study. One subject was delayed because the solution for the infusion had particles in it and then didn't continue(didn't receive any intervention) due to funding issues, and the second one was enrolled but didn't receive any intervention due to funding issues that have been explained.
745707|NCT00865345||
745708|NCT00865306|Study recruitment for the controlled trial occurred between February 2001 and January 2004. Children were recruited from the outpatient child psychiatry clinic at a general hospital, as well as through print ads in local newspapers and parent magazines, email advertisements to hospital employees, and posters at local pediatrics practices.|We screened 103 children for the controlled trial, to enroll our target goal of 60-65 children. Of these 14 were ineligible (3 did not meet inclusion criteria, and 9 met exclusion criteria). Another 13 withdrew prior to completing baseline assessments, and 11 who did not complete baseline assessments were lost to follow-up. Thus 65 were enrolled.
745709|NCT00865202||
745710|NCT00865189||A total of 92 participants with resectable rectal cancer were selected and 91 participants were randomized into the study. One participant was not randomized due to non-compliance with the inclusion/exclusion criteria.
745711|NCT00865124||
745712|NCT00865098|Subjects were enrolled in this study at 4 centers in Japan. The first subject was enrolled on 06 March 2009 and the last on 04 January 2010.|27 subjects were enrolled and 5 were ineligible, not treated, and excluded from the Intention To Treat (ITT)/Safety Population. Reasons: investigator's decision (1 subject), withdrawal of consent (1 subject), inability to perform radiation therapy according to protocol (2 subjects) and inclusion/exclusion criteria not fulfilled (1 subject).
745713|NCT00865046||
745714|NCT00865020||1359 participants entered the Placebo Run-In phase which was 1-2 weeks in duration. Those participants completing the Placebo-Run-In Phase were randomized to receive either aliskiren 300 mg or telmisartan 80 mg.
745715|NCT00864916||
745716|NCT00864851||
745717|NCT00864721||
745718|NCT00864708|Dec 2008 - October 2009, recruitment by flier and by word of mouth|
745719|NCT00864682|Patients entered were recruited between January 2008 and March 2009. Hospital / ambulatory surgery setting|
745720|NCT00864539||
745721|NCT00864513|From 12/2007 to 3/2009 17 patients were enrolled; 2 of which did not receive any treatment.|
745722|NCT00864474||
745723|NCT00864383||
745724|NCT00864253|This multicenter study was conducted by investigators in 9 countries: Australia, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom and the United States (US) and treatment was given on an outpatient basis. First participant enrolled 30 April 2011, last participant enrolled June 2011..|Participants were randomized in a 1:1 ratio. Randomization was stratified based on metastatic stage (M1a, M1b, and M1c), region (North America, Western Europe and Australia), and baseline lactate dehydrogenase (LDH) (< 0.8 * ULN, 0.8-1.1 * ULN, >1.1-2 * ULN).
745725|NCT00864227||
745726|NCT00864123||Excluded (n = 22) Not interested in participating in study (n=9) Changing medication at Baseline (n=5) Did not receive at least one DCS dose (n = 4) History of adequate CBT course (n=2) Met criteria for comorbid autism (n=1) Did not show up for pre-treatment assessment (n=1)
745727|NCT00864084|Eleven individuals with stable chronic respiratory disease who were attendees of an institutional outpatient pulmonary rehabilitation program participated in this study. Recruitment occurred in April 2009 and at the pulmonary rehabilitation program.|People enrolled in the pulmonary rehabilitation programs who had a clinical diagnosis of respiratory disease were included in the study. Exclusion criteria were: unstable cardiac disease, neurological conditions, or musculoskeletal conditions that prevented participation in pulmonary rehabilitation or testing sessions.
745728|NCT00864032||
745729|NCT00863928|November 1, 2008 through July 30, 2009. Subjects recruited at medical center|
745730|NCT00863798||A total of 898 potential participants were screened for this study. 804 participants were enrolled and received single-blind placebo during the screening period prior to randomization.
745731|NCT00863746||
745732|NCT00863707||
745733|NCT00863681|Study was conducted at 97 centers in 27 countries between 12-MAR-2009 (first participant first visit) and 19-AUG-2019 (last participant last visit);|Of the 405 participants who completed PATENT-1(NCT00810693) study, 396 participants entered PATENT-2 study. 231 participants were from the former riociguat 1.0-2.5mg group, 109 were from the former placebo group and 56 were from the former riociguat 1.0-1.5mg group.
745734|NCT00863655||Although 724 patients were randomized, 4 never received any study treatment and thus were excluded form the safety set.
745735|NCT00863551||
745736|NCT00863512||
745737|NCT00863434||
745738|NCT00863356|Patients were recruited from a tertiary rhinology fellowship training clinic from January 2009 to November 2009.|
745739|NCT00863343|391 participants were selected from multiple U.S.Primary Care sites and exhibited influenza-like illness|no participants were excluded
745740|NCT00863330||14 participants were enrolled. For those, 8 were screen failures and 6 started the study.
745741|NCT00863317||
745743|NCT00863122|All patients undergoing surgery for vestibular schwannoma resection who met eligibility criteria were invited to participate|Patients could enroll on control (no drug) or lapatinib arms. 20 people were consented for the the lapatinib arm, but one patient withdrew consent prior to completion of eligibility screening and enrollment. So 19 patients enrolled on the lapatinib arm.
745744|NCT00863109||Of 133 participants who enrolled on study, 3 participants failed screening and 130 were evaluable for this study.
745745|NCT00863057|Participants were recruited across 8 of 15 study sites in the AIDS Clinical Trials Group system between August 2009 and October 2010. The sites were: Harbor-UCLA Medical Center, Harvard MGH, Houston AIDS Research Team, Metrohealth Medical Center in Cleveland, Northwestern University, UC San Diego Medical Center, Washington Univ., Univ. of Colorado.|
745746|NCT00862979|232 patients were screened, of these , 193 patients were included in safety set which included 31 non-randomized and 162 randomized. Of these, 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable and included in the Full Analysis Set FAS.|
745747|NCT00862940|The patients were recruited from each investigator's outpatient clinic.|After a 3-week run-in period during which MRI scans were performed, the patients were randomised to either placebo or memantine and stratified according to AChEI treatment. Memantine-treated patients started with 5 mg/day and were uptitrated by 5 mg/day every week for 4 weeks. The target dose of 20 mg/day was administered from the start of Week 4.
745748|NCT00862849||
745749|NCT00862836||"Phase I of the trial consisted of a safety run-in phase of 10 patients with histologically confirmed, epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory or partially sensitive to platinum-based therapy evaluable for at least 2 cycles.
~Phase II of the trial was not conducted."
745750|NCT00862823|Healthy volunteers recruited in Birmingham, AL from March 2009 and August 2009|
745751|NCT00862810||
745752|NCT00862784||Completer was defined as any participant who died due to any cause or progression of disease, or any participant who was alive and on study but off study treatment at the conclusion of the study.
745753|NCT00862745|Participants were recruited from the general community surrounding 13 clinical sites across the United States between January 2009 and December 2009.|Participants screened over 4 week period.
745754|NCT00862719|Initially based on single arm 2 stage design using 600 mg sitagliptin/24 hrs in RBC replete and RBC depleted UCB units. In an unplanned interim analysis after 1st 20 enrolled pts, protocol was amended to exclude RBC replete UCB units due to worse outcomes and to test more frequent dosing of sitagliptin due to suboptimal inhibition of plasma DPP-IV.|
745755|NCT00862654||
745756|NCT00862641||
745757|NCT00862563||
745758|NCT00862537||
745759|NCT00862459|The date of the first participant's first visit was 27 August 2005. The date of the last participant's last visit was 26 March 2007.|242 participants were screened: 5 were screening failures (withdrew consent, did not meet study criteria, other). The remaining 237 were randomized to the 0.3, 0.1, or 0.03 millimole per kilogram (mmol/kg) group.
745760|NCT00862446||
745761|NCT00862277|Participants were enrolled from 16 December 2008 to 16 March 2009 in 21 medical centers in the US.|A total of 763 participants who met the inclusion and exclusion criteria were enrolled. One participant withdrew before sampling and is excluded from analysis and this report.
745762|NCT00862251||
745763|NCT00862186||
745764|NCT00862134||
745765|NCT00862121||
745766|NCT00862082||
745767|NCT00861913|From April 2009 to July 2009, 13 participants were registered.|All participants were evaluable for all endpoints and toxicity.
745768|NCT00861757||
745769|NCT00861744|The study was divided in 3 phases: the active phase (up to Day 42), the extended safety follow-up (ESFU) phase (up to Day 180) and the antibody persistence phase (up to Day 730).|The number of subjects enrolled was 1259. 39 subjects were enrolled in the study but did not receive a subject number and were never vaccinated.
745770|NCT00861705||
745771|NCT00861692||
745772|NCT00861614||988 enrolled, 799 randomized (399 ipilimumab, 400 placebo); 149 no longer met study criteria, 17 withdrew, 6 adverse events, 4 died, 1 lost to follow-up,12 unspecified. 789 treated with radiotherapy (393 ipilimumab, 396 placebo); 2 no longer met study criteria, 3 withdrew consent, 1 died, 2 adverse events, 2 lost to follow-up.
745773|NCT00861601||
745774|NCT00861471|12 patients were enrolled between Sep. 2006 and Nov. 2008 for the Phase II part of the study in New York University Medical center and affiliated hospitals.|Once the optimal combination dose of Docetaxel (Taxotere) and Gleevec (Imatinib Mesylate) was determined in the Phase I part, the study proceeded to Phase II. There were 12 patients in Phase I and Phase II, respectively. The results reported here are only for Phase II.
745775|NCT00861380|This study also served as basis for conducting a long-term evaluation of the impact of vaccination with GSK Biologicals' 10Pn-PD-DiT vaccine. Subjects of the 10PN-PD-DIT-053 (112595) study (NCT00839254-EUDRACT:2008-006551-51) contributed to the objectives of this study.|41188 subjects were enrolled in the study, 7 subjects didn't receive any vaccination, 41181 subjects started the study. Total population assessed for combined analyses performed on both studies included 45977 subjects, see details in groups description.
745776|NCT00861341||
745777|NCT00861263|We started this study in June 2007 and ended this study in Oct 2012. We approached any patient who was scheduled in our endoscopy suite for an overtube enteroscopy.|The only significant event was that the subject was scheduled for an enteroscopy in our facility and a overtube was used at the time of endoscopy.
745778|NCT00861198||There were 88 participants who were enrolled into the study; however, 13 were excluded because they did not qualify for the SpyGlass examination.
745779|NCT00861146|"Enrollment May 2009 to October 2012.
~Excluded (n=1448):
~Does not smoke, does not drink (n=678) Declined to participate (n=320) Medical problems (n=297) Otherwise ineligible (n=112) Male non-vet (n=41)"|
745780|NCT00860951||
745781|NCT00860938|out patient clinic|run-in
745782|NCT00860847|65 patients were recruited|completed
745783|NCT00860795|Healthy adults were recruited using general advertising and enrolled between March and August 2009|
745784|NCT00860743|This study recruited participants between the years 2009-2013. The study was completed at the John D. Dingell VA Medical Center.|"Participants did not meet the inclusion criteria. This was typically due to EKG abnormalities or high blood pressure.
~Participants completed a practice run following consent to introduce them to equipment and procedures. Some participants choose not to continue following the practice run usually because of discomfort."
745785|NCT00860535||
745786|NCT00860470|Enumeration of women began in December 2007, and active recruitment of pregnant women into the trail began in January 2008. Women were enrolled into the trial by community workers from the projects who visited them at home.|
745787|NCT00860457||
745788|NCT00860405|Participants were recruited in paediatric care units of 2 hospitals in Austria and Belgium from March 2009 (FPI) until July 2010 and were followed up until August 2010 (LPO).|Participants were screened in paediatric care units of the participating 2 study sites in Austria and Belgium.
745789|NCT00860314||
745790|NCT00860262||
745791|NCT00860249|The trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. The trial enrolled patients between March and December 2009.|We used data contained in the clinic's electronic health record to identify eligible patients. All eligible patients were randomly assigned to one of the three study arms.
745792|NCT00860171||
745793|NCT00860158||
745794|NCT00860067|A total of 1,924 participants provided written informed consent and were screened for the study. Of these, 1,800 participants were randomized into the study at 18 sites in the USA from 23Mar2009 and 26Mar2009.|Participants who provided written informed consent and who met the eligibility criteria were randomized by site at a 4:1:1 ratio to receive Q/LAIV, FluMist/B/Yamagata, or FluMist/B/Victoria. The randomization incorporated a block design with a fixed block size of 6.
745795|NCT00860028|Outpatient research clinic|Prior to randomization, inclusion and exclusion criteria were assessed. Reasons for exclusion included health problems, not meeting drinking/smoking criteria, other drug use, and depression requiring treatment.
745796|NCT00860015||
745797|NCT00859976||
745798|NCT00859950||
745799|NCT00859937||
745800|NCT00859898|Participants were recruited from 13-April-2009 to 26-November-2009. Study completed 12-May-2010. Drug naive participants with Type 2 Diabetes Mellitus who had inadequate glycemic control with diet and exercise. Inadequate glycemic control was defined as a hemoglobin A1c (HbA1c) ≥ 7.5% and ≤ 12.0%.|Qualification: 660 completed: 28 administrative, 373 no longer met criteria, 1 lack of efficacy, 26 withdrew consent, 1 lost to follow up (LTF), 4 other. Lead-In: 649 entered; 641 completed/ randomized: 1 adverse event, 1 administrative, 4 no longer met criteria, 1 withdrew consent, 1 LTF. Treated 638: 1 LTF, 1 non-compliance, 1 withdrew consent.
745801|NCT00859833|Patients were recruited from medical clinics and by advertising within the hospital.|
745802|NCT00859651||Data for this study (NCT00859651; n=20 postmenopausal; 8 received 20,000 IU/week and 12 received 30,000 IU/week) is combined with the data for another study (NCT00976339; n=20 premenopausal; 10 received 20,000 IU/week and 10 received 30,000 IU/week). Resulting in a combination of 18 receiving 20,000 IU/week and 22 receiving 30,000 IU/week.
745803|NCT00859638|Participants were recruited from two distinct locations of the McMaster Family Health Team.|
745804|NCT00859586||
745805|NCT00859573|A total of 20 participants were recruited into the study between 5/26/2009 and 3/30/2010. However, only 9 participants entered the study with 11 dropping out during the consent or intake process. They were recruited from newspaper advertisements and word-of-mouth advertising and who meet the following criteria.|
745806|NCT00859547|Of the 32 participants who signed informed consent in this study, 30 were actually enrolled and received treatment with rThrombin.|
745807|NCT00859521||
745808|NCT00859508|The trial was approved to enroll subjects from a maximum of 10 US medical institutions (public and academic research center hospitals). Subjects were enrolled from February 2006 to June 2008.|A total of 105 patients that initially met the inclusion/exclusion criteria were enrolled and randomized. Of those 105 patients, 99 received surgical treatment. Of those not treated, reasons included: change in diagnosis, not meeting Inclusion/Exclusion criteria, subject voluntary withdrawl, and investigator decision.
745809|NCT00859495||
745810|NCT00859469|Patients will be screened using standard health care assessments and tests. All of these tests must be done within 4 weeks before patients begin treatment.|Patients who are deemed eligible will start the treatment cycle, defined as an interval of 14 days, and comprising of treatment with Gemcitabine followed immediately by Oxaliplatin.
745811|NCT00859456||1 subject decided to pursue treatment elsewhere prior to receiving study drug after consent.
745812|NCT00859430||
745813|NCT00859339||
745814|NCT00859313||
745815|NCT00859222|Participants in the Phase I study enrolled from March 2009-January 2011 and the Phase II study from June 2011-May 2013.|
745816|NCT00859131||
745817|NCT00859053||A total of 46 participants were enrolled in the study, of which 30 participants were treated with study drug and 16 participants were not treated with study drug as they no longer met study criteria.
745818|NCT00859040||
745819|NCT00859027|Subjects recruited from medical clinics/ urology clinics.|
745820|NCT00859014||
745821|NCT00858988||
745822|NCT00858962||
745823|NCT00858858||
745824|NCT00858845|All heart failure patients were recruited from the Ahmanson-University of California, Los Angeles (UCLA) Cardiomyopathy Center between 2008-2011.|"Of 44 heart failure patients interested, 25 were ineligible (medication changes (6), too well with either left ventricular ejection fraction(LVEF) >35% (3) or New York Heart Association (NYHA) Class I (2), transportation issues (4), morbidly obese (3), enrolled in exercise program (2), other (5)), and of the remaining 19 patients, 8 declined."
745825|NCT00858832|Recruitment began 01dec2008 and was terminated 30apr2010. All recruitment was in a hospital.|There were no washouts or run-ins. Patients were eligible upon the decision for a Cesarean delivery and then consented and randomized.
745826|NCT00858780||
746708|NCT00819403|All patients have been recruited and 15 have successfully completed the study.|Patients excluded included those unable to tolerate statin and/or ezetimibe treatment
745827|NCT00858702|A total of 172 patients were enrolled at 5 centers in Japan from February 12, 2005 to April 30, 2005.|After the 4 to 6 weeks of olmesartan medoxomil monotherapy period, 105 patients who met the entry criteria for the combination therapy period were randomized to calcium channel blocker (of the dihydropyridine class) combination group or diuretic (of the thiazide class)combination group.
745828|NCT00858689|Twenty subjects with FXS between 13 and 35 years of age were enrolled between December 2007 and June 2008, and after baseline testing they were started on an 8-week treatment course of minocycline added on to any other medications being administered at the time of enrollment.|Inclusion criteria included (1) diagnosis of FXS by clinical evaluation and confirmed by FMR1-DNA testing with presence of full mutation or mosaicism for the full mutation.
745829|NCT00858637||
745830|NCT00858507||
745831|NCT00858494|Children diagnosed with an upper respiratory tract infection (URI) at a pediatric clinic were recruited for the study from March to September 2009|one participant who was enrolled had a positive test for streptococcal pharyngitis at the index visit and was prescribed antibiotics. This participant thus became ineligible.
745832|NCT00858468|Participants were enrolled from 08 April to 05 August 2005 in 8 medical centers in the US|A total of 394 participants that met the inclusion and exclusion criteria were enrolled, 393 were vaccinated.
745833|NCT00858442|Participants were recruited on the day of the scheduled surgery. The researcher checked the inclusion criteria. Explained to the parents and patient surgical procedure, risk of complications and are invited to participate voluntarily in the study. Informed consent is signed. They recruited 44 children in total between April 6,2009 and August 9,2011|Potential candidates to enter the study were 80. Of these, 20 were excluded for having a weight less than 35 kg; 15 for failing to ensure their attendance at the controls and 1 have coagulation disorders
745834|NCT00858403||
745835|NCT00858390|Thirty-six (36) brain dead organ donors were randomized in a 1:1 ratio to standard care (fasting) or to receive the nutritional intervention via naso/oro-duodenal feeding. Consent was obtained from family members for subject participation. Organ donors were screened and enrolled between 2/2009-6/2011.|Inclusion criteria: consented brain-dead organ donors age 14 to 70 years; may have received parenteral/enteral nutrition prior, but were excluded for prior gastric/bowel resections, GI malabsorption, bariatric procedures, vagotomy, pyloroplasty, or pancreatitis. Donors were excluded if a FiO2 greater than 60% was required (REE).
745836|NCT00858364|This study was conducted at 371 centers in Europe, Latin America, Asia, India, North America, Israel, and South Africa.|Eligible participants were randomized to darbepoetin alfa or placebo in a 2:1 ratio. Randomization was stratified by histology (squamous vs other), screening hemoglobin (< 10.0 g/dL vs ≥ 10.0 g/dL), and geographic region.
745837|NCT00858247|Participants were enrolled at the Mayo Clinic in Rochester, Minnesota.|
745838|NCT00858208||
745839|NCT00858143||Somavert® (active ingredient: Pegvisomant 10/15/20 mg). Dose and schedule were at discretion of each treating physician. Safety evaluations based on all 311 patients who received at least one dose of Somavert® (safety set). Results from 270 patients in the intent-to-treat (ITT) population were analyzed to evaluate the efficacy of Somavert® therapy.
745840|NCT00858130||
745841|NCT00858117|The study opened for accrual on 29th March 2005 with the first patient starting treatment 26th September 2005 and an accrual goal of 30 patients. The study closed to further enrollment on the 26th October 2009 with 30 patients treated on study.|
745842|NCT00858013||
745843|NCT00857961||
745844|NCT00857948|Participants were enrolled and treated on 14 March 2009 in 1 US clinical center.|A total of 78 participants who met the inclusion and exclusion criteria were enrolled and treated.
745845|NCT00857896||
745846|NCT00857857|Total 24 participants were enrolled from February-2009 to November-2009. ROTADISK™, DISKHALER™ and DISKUS™ were registered trademark product of GlaxoSmithKline.|Participants with pre-bronchodilator forced expiratory volume in 1 second (FEV1) >65% predicted at Screening, positive wheal and flare reaction (>=3 millimeter) on skin prick testing, early asthmatic response (EAR) and late asthmatic response (LAR) had to include a fall in FEV1 of >=20%, >=15%, respectively from the post saline value were included.
745847|NCT00857818||Of 64 patients enrolled, 36 were screen failures, and 28 were randomized. Of those randomized, 26 received treatment.
745848|NCT00857792||
745849|NCT00857766||
745850|NCT00857727|33 children undergoing general anesthesia for endovascular interventional procedures. 28 patients provided complete data sets.|
745851|NCT00857714|Thirty patients were expected for this trial but it stopped at one patient due to difficulty with recruitment.|
745852|NCT00857649|The patients were recruited from the investigators' outpatient clinics.|At the Baseline Visit, the patients were randomised (1:1) to 24 weeks of treatment with placebo or memantine. Patients randomised to memantine were up-titrated in weekly increments of 5 mg over a 4-week dose-escalation period. The target dose of 20 mg/day was administered at the start of the fourth week and maintained for the rest of the study.
745853|NCT00857623|This multicenter study was conducted between February 2009 and August 2009in the United States.|The study consisted of a 42-day enrollment phase (including washout and baseline period), a 28-day treatment phase (10-day inpatient and 18-day outpatient) where patients were randomized to AZD2066 or placebo, and a 7-day follow-up phase. Patients randomized to treatment with AZD2066 received 12 mg from Days 1 to 4 and 18 mg from Days 5 to 28.
745854|NCT00857584||
745855|NCT00857545|The study was activated on 7/26/2010 and closed to accrual on 2/4/2013.|
745856|NCT00857532||
745857|NCT00857506|All subjects were recruited from participants in study 18F-AV-45-A05 (NCT00702143)|
745858|NCT00857493||
745859|NCT00857454|This was an open-label extension to the MTE08 trial. Only participants in the MTE08 trial who consented and met eligibility criteria could be enrolled in MTE09.|Participants received 3.0 mL (60 mg) of 2% Testosterone MD-Lotion for 60 days, and may have had their dose adjusted upwards or downwards (Subjects in MTE09 were continued on the dose that they were taking at the conclusion of study MTE08. A total of 2 patients received 30 mg; 49 remained on 60 mg, 12 received 90 mg; and 8 received 120 mg).
745860|NCT00857415||
745929|NCT00854308||Twenty-seven patients in the placebo + erlotinib arm with disease progression in the blinded treatment stage elected to receive MetMAb + erlotinib in the optional open-label phase of the study.
745861|NCT00857389|This study received IRB approval October 1, 2008 and was opened to recruitment March 2, 2009. The study remained open to recruitment until August 4, 2015. The study was terminated by the local IRB on April 09, 2019.|Of the 60 participants enrolled, 2 participants did not proceed to transplant no data were collected for those two participants
745862|NCT00857311|All participants had to be at low risk of acquiring human immunodeficiency virus (HIV) infection, and had to meet a number of laboratory criteria. They could not have received treatment for hepatitis C virus infection in the 3 months prior to enrollment and must not anticipate to begin treatment with in 1 year after enrollment.|
745863|NCT00857285|A total of 181 subjects were screened at 3 study sites in Taiwan from May 2002 to April 2003, and 51 subjects had dropped as screen failure.|After a taper off period for 1 week, if necessary, and a placebo run-in period for 2 weeks, 130 subjects were randomized to olmesartan 20mg and losartan 50mg by 1:1 ratio.
745864|NCT00857272||
745865|NCT00857259||
745866|NCT00857246|From October 2005 to November 2010, 30 patients were enrolled to the study from New York University Langone Medical Center and its affiliated hospitals.|
745867|NCT00857233|This was an interventional, multi-centre, open-label, fixed-dose extension study to Study 10158. The Baseline visit in Study 10252 was scheduled to occur at the same time as the Week 24 Visit in Study 10158.|Placebo patients from Study 10158 were uptitrated in weekly increments of 5 mg over a 4-week, double-blind period. Target dose of 20 mg/day was reached at the start of the 4th week and maintained for the rest of the study. Memantine patients in Study 10158 continued on 20 mg/day. From the end of Week 4, the study was open-label.
745868|NCT00857220||The participant flow section includes all subjects randomized. The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. One subject did not receive study medication.
745869|NCT00856999|Recruited from medical practice and IRB approved media placement|
745870|NCT00856986|A total of 202 centres in 9 countries: Belgium (2), Canada (7), France (19), Germany (37), Italy (18), the Netherlands (16), Spain (14), the United Kingdom (32) and the United States (57)|Subjects on metformin and/or sulpholynurea treatment underwent a 12-week run-in period with liraglutide + metformin. Subjects not achieving an HbA1c below 7% were randomised to liraglutide + metformin treatment with/without insulin detemir. Subjects achieving an HbA1c below 7% continued liraglutide + metformin treatment.
745871|NCT00856973||Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of participants in the Baseline Characteristics refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period. Three subjects did not receive study medication.
745872|NCT00856934||
745873|NCT00856908||
745874|NCT00856856|Total of 101 patients (intent to treat patient population [ITT]) were enrolled in the ABSORB Cohort B study at 12 clinical sites in Europe/Australia/New Zealand between March 19, 2009 and November 6, 2009. Only for assessing imaging outcomes at different follow-up periods, subjects were divided into Group 1 (n = 45) & Group 2 (n = 56).|ITT population were assessed for all clinical endpoints. For imaging outcomes,Group 1 (n=45) patients were followed up at 180 days, 2 & 5 years; while Group 2 (n=56) patients at 1, 3 & 5 years. Therefore, data related to imaging outcomes are available only for Group 1 at 180 days, 2 & 5 years timeframe & only for Group 2 at 1, 3 & 5 years timeframe
745875|NCT00856843||
745876|NCT00856830|Protocol Open to Accrual: April 2009, Primary Completion Date: May 2015 and Study Completion Date: May 2016. Recruitment location: University of Alabama at Birmingham and Georgia Cancer Specialists.|We are proposing a novel combination of bendamustine plus irinotecan followed by the standard regimen of etoposide with carboplatin. This will allow the investigation of response to the novel combination as well as any improvement in outcomes compared to historical controls.
745877|NCT00856791|The study was conducted at one site in the United States. One patient was enrolled and treated, after which, the study was closed due to slow enrollment.|
745878|NCT00856778||
745879|NCT00856739||
745880|NCT00856726||
745881|NCT00856661||
745882|NCT00856635||
745883|NCT00856609||Out of 150 planned total number of enrollment, 145 participants were recruited. Among the 145 participants, 84 participants met inclusion criteria. Only 80 participants out of 84 were randomized.
745884|NCT00856583|593 centres in 38 countries (Europe and Asia). First patient first visit: 11 July 2002. Last patient last visit: 22 February 2008.|
745885|NCT00856557|Resident physicians were consented and recruited from two clinical training facilities on a rolling basis over 30 months.|
745886|NCT00856544||
745887|NCT00856518||
745888|NCT00856492||
745889|NCT00856414||
745890|NCT00856388||
745891|NCT00856349|Subjects were enrolled in the Shock-Less study between April 2009 and January 2012 from 118 centers worldwide in North America, Central/South America, Australia/New Zealand and Asia.|A total of 252 (6%) out of the 4384 enrolled subjects were excluded from the analysis cohort due to the following reasons: baseline device interrogation not available (217/252; 86%), inclusion/exclusion criteria not met (16/252, 6%), indication for ICD implant not specified (11/252; 4%), and VF therapy/detection not turned ON (8/252; 3%).
745892|NCT00856323|Between March 2009 and August 2010, 358 individuals inquired about the study on the basis of recruitment efforts, 64 presented for screening, and 53 participants enrolled in the study.|Reasons for Screen Failure (N = 7): HIV-positive at baseline screening; negative urine screen for methamphetamine§; did not complete baseline assessments; provided incorrect information at phone screening.
745893|NCT00856297|Subjects were recruited from 19 sites in US.|All enrolled subjects were included in the trial.
745894|NCT00856284|Participants took part in the study at 310 study sites worldwide from 05 March 2009 to 17 October 2012.|Participants with type 2 diabetes mellitus experiencing inadequate glycemic control while on metformin therapy were enrolled equally in 1 of 3 treatment groups: alogliptin 12.5 mg once daily (QD), alogliptin 25 mg QD, and glipizide 5 mg QD.
745895|NCT00856245||
745896|NCT00856232||
745930|NCT00854113||
745931|NCT00854100||The randomized population for RGH-MD-71 totaled 231 participants
745932|NCT00854087||
745933|NCT00854061||
745934|NCT00853996||
745897|NCT00856206|The study was conducted at 71 study sites in United States and rest of world (ROW) between 23 March 2009 and 14 January 2011. A total of 2311 participants were screened in the study.|Out of 2311 participants, 1315 were randomized and treated in the study. Participants were randomized in 3:1 ratio to receive Rilonacept 160 mg or placebo.
745898|NCT00856193||Patients were randomized into one of two sequences to receive either NVA237 50 μg followed by placebo or placebo followed by NVA237 50 μg.
745899|NCT00856180|20 patients were enrolled between March 2009 and October 2009.|
745900|NCT00856050||27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.
745901|NCT00856024||
745902|NCT00855959|Outpatients, male and female ≥ 16 years with stable asthma|
745903|NCT00855933||
745904|NCT00855920|The study was conducted at 80 study sites in North America between 16 March 2009 and 26 February 2010. A total of 747 participants were screened in the study.|Out of 747 participants, 225 were randomized and treated in the study. Participants were randomized in 1:1:1 ratio to receive one of the three treatment groups (Placebo [for Rilonacept] + Indomethacin or Rilonacept 320 mg + Indomethacin or Rilonacept 320 mg + Placebo [for Indomethacin]) on Day 1 of the study.
745905|NCT00855894||Patients were considered to have completed the study if they were alive at their last survival follow-up visit prior to 10 Nov 2011, which was 1 year after the last patient was enrolled, or they were continuing treatment per Amendment 3 of the study protocol (1 patient).
745906|NCT00855868||
745907|NCT00855842|Women requesting abortion at 19-23 weeks were eligible to enroll if they were able to consent and had no contraindications to medical abortion. Women were informed of the study after all counseling for abortion was completed and after they had given consent for abortion|Women were eligible for study intervention if they had singleton pregnancy with intact membranes, without signs of infection.
745908|NCT00855816||
745909|NCT00855738||Given the observational nature of the study, the selection of treatment and dose of study medication was independent from participation in the study and was determined by daily clinical practice.
745910|NCT00855595||
745911|NCT00855582||There is a 4-week washout during Screening in order to assess symptoms and uroflowmetry data in the absence of therapy. After the screening/washout period, subjects began a 4-week single-blind, placebo lead-in period to assess treatment and study procedure compliance and to establish baseline levels.
745912|NCT00855465|Only subjects with symptomatic chronic thromboembolic pulmonary hypertension (CTEPH) could participate in this study. CTEPH was defined either as inoperable or as persisting or recurrent PH after pulmonary endarterectomy.|446 subjects were screened in 89 study centers in 26 countries worldwide. 184 of the 446 screened subjects were not randomized (adverse event [1], death [4], protocol violation [164], withdrawal by subject [15]). 262 of the 446 subjects were randomized. 261 of the 262 randomized subjects received study medication.
745913|NCT00855439|Date of first patient randomized to treatment:10/29/2008 Date of last patient randomized to treatment:12/07/2012|After obtaining written informed consent, participants were asked to provide medical history. A physical examination was performed, with specific focus on signs and symptoms of peripheral neuropathy. Baseline labs were obtained. Eligible subjects were invited for a baseline visit at which detailed neurologic assessment were done.
745914|NCT00855413|Individuals diagnosed with acute HIV in clinical sites within 30 days of enrollment and at least 18 years of age were enrolled. Acute HIV defined as: i) negative EIA and positive NAT; ii) positive EIA and positive NAT with negative/indeterminate western blot (WB); or iii) positive EIA, positive WB and EIA negative documentation in prior 30 days.|
745915|NCT00855335||
745916|NCT00855309||
745917|NCT00855218||
745918|NCT00855166|First participant enrolled: 13 Feb 2009. Last participant completed 24 week period: 03 Jun 2010. 314 participants were enrolled, 182 were randomized in 40 centers in 5 European countries. Men aged 30-75 years and women aged 55-75 years with inadequate glycemic control (HbA1c 6.5% to 8.5%), BMI of at least 25 kg/sqm and body weight <= 120 kg.|During a placebo lead-in period, participants were counselled on dietary and life-style modifications. The metformin dose was adjusted to open label 1500 mg/day, 2000 mg/day or 2500 mg/day. Neither gender should exceed 60% of the total number of randomized participants.
745919|NCT00855062|The recruitment period was from Mar 2008 to Oct 2009 when the study was stopped early (Data and Safety Monitoring Board (DSMB) decision based on futility) on Nov 2009. The study participants were recruited from the Infectious Disease Institute, Makerere University, Kampala, Uganda.|"Total of 353 participants were screened; only 73 were randomized and thus 280 were not enrolled: 146 of them did not have cognitive impairment, 55 of them lacked laboratory inclusion criteria, and 79 of them had others."
745920|NCT00855010||
745921|NCT00854906|All qualifying patients who were scheduled in the Jones Eye Institute Clinics for a complete eye exam were offered information about the study and invited to participate. Participants were recruited from February 29, 2009 to April 14, 2009.|Participants who did not meet the study protocol's inclusion and exclusion criteria were not included the study or study data analysis. All subjects eyes were measured for first for KTBUT and second for FTBUT. Each measurement occured three times in each eye and the results were recorded in seconds during their office visit and averaged.
745922|NCT00854724||
745923|NCT00854620||
745924|NCT00854607||
745925|NCT00854594||Cleveland and Cincinnati CBOCs (excluding Georgetown; n = 18 CBOCs) were the study sites randomized to the two study arms. Providers within site were subject to the intervention to which the site was randomized and the questionnaire responses were collected at the provider level.
745926|NCT00854581||
745927|NCT00854373|Women undergoing a long agonist suppression IVF protocol at one U.S. academic center were recruited to participate|232 consented for the study; 44 were excluded for eligibility criteria
745928|NCT00854360|A total of 685 patients were screened and 635 were enrolled in the study and participated in the Run-in Period. Of the 635 enrolled patients, 487 were randomized to treatment. The study was performed in the spring during tree and grass pollen seasons.|During the 7 - 21 day Run-in Period, patients self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their twice daily allergic rhinitis symptoms to determine eligibility for randomization.
745935|NCT00853970|The first participant entered the study on 02/09/2009, and last participant exited the study on 07/06/2009. This study took place at 41 sites in the USA|152 participants were randomized to the bromfenac ophthalmic solution 0.09% treatment group and 147 were randomized to the placebo treatment group. One hundred forty six of 152 participants (96.1%) in the bromfenac ophthalmic solution 0.09% treatment group and 144/147 (98.0%) participants in the placebo treatment group completed the study.
745936|NCT00853957||
745937|NCT00853905|February 2009 to July 2011 at the Wills Eye Hospital|
745938|NCT00853840||All subjects received 3 to 4 days of maraviroc 300 mg twice daily (BID) before receiving single oral doses of either vardenafil 20 mg (Treatment A) or placebo (Treatment B).
745939|NCT00853827||
745940|NCT00853762|First/last participant (informed consent): 03 March 2009/13 August 2009. Last participant completed: 09 September 2009.|A total of 324 subjects were screened and 255 were enrolled in ATAMS (28063; NCT00642902). Overall, 75 subjects randomized and treated in ATAMS were eligible to enter ATAMS Extension. However, 74 subjects were included in ATAMS Extension and 1 subject could not enter due to the premature termination of the trial.
745941|NCT00853749||
745942|NCT00853723||
745943|NCT00853671|Recruitment Period: 3/3/2008 - 7/1/2009|
745944|NCT00853658||During Active Run-in period, patients received enalapril for step 1 & 2 and then aliskiren on top of the max tolerated dose of enalapril for step 3. Patients who completed the run in were randomized in a 1:1:1 ratio to one of the 3 treatment arms (aliskiren/enalapril combination therapy, aliskiren monotherapy, or enalapril monotherapy).
745945|NCT00853606|Subject recruitment occurred at US investigative sites between March 2009 and April 2010.|
745946|NCT00853593||
745947|NCT00853580|Participants were recruited between July 2009 and May 2014 from 11 specialist NF1 academic clinics affiliated with the NF Clinical Trials Consortium.|After obtaining consent, participants were screened for study inclusion. If entry criteria were passed, they were randomized to study. All randomized participants were included in the primary efficacy analysis (baseline-to-post treatment) if they completed the baseline assessments.
745948|NCT00853567||
745949|NCT00853489||34 consented One was inelgible at time of graft due to infection pre enrollment Two were outside study period One Administrative withdrawl Total randomized : 30
745950|NCT00853385||
745951|NCT00853372|This study was conducted at 18 sites in the United States, Australia, Belgium, France, and Poland. The first participant was enrolled on 28 May 2009. The last participant was enrolled on 29 November 2010.|
745952|NCT00853333||
745953|NCT00853307|Participants took part in the study at 17 investigative sites in France, Poland and the United States from 23 March 2009 to 27 January 2011.|Participants with a diagnosis of Platinum-refractory and Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma received 50 mg alisertib twice daily for 7 days in 21-day cycles.
745954|NCT00853242|The study was conducted at 64 centers in the United States between 11 February 2009 and 20 August 2009.|A total of 670 participants were screened of which 321 were screen failure and 349 participants were randomized. After screening, participants entered a two-week phosphate binder washout period prior to randomization.
745955|NCT00853229||
745956|NCT00853151||Reporting on 131 participants who received either TT223 or its placebo and reflects data from treatment and follow-up. 151 enrolled in run-in. 16/130 randomized to LY2428757 run-in did not get treatment assignment. 3/21 assigned to placebo run-in did not enter treatment phase. 1 was given treatment assignment but never received TT223 or placebo.
745957|NCT00853125|Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 02/03/2009 and closed to accrual on 05/07/2013 because of slow accrual.|We are reporting results on 10 eligible patients. Five patients were deemed ineligible.
745958|NCT00853112||
745959|NCT00853099||
745960|NCT00853073|Eligible patients were recruited between February 2009 and July 2011 from the Glaucoma Service located at Wills Eye Hospital in Philadelphia.|
745961|NCT00853047|A total of 23 participants were enrolled in the Core Phase (ie, Screening and Double-blind Treatment Period) from 11 sites, including 1 satellite site, in the United States. 19 participants entered the Open-label Extension Phase.|
745962|NCT00853021||
745963|NCT00852995|Subjects were screened at 34 sites in the US and one in Canada, between June 11, 2009 and May 5, 2011; sites included independent and hospital wound clinics and private practice sites.|Subjects entered a 2-week run-in; subjects whose wound radius decreased by < 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization.
745964|NCT00852969|All patients were recruited at Tufts Medical Center. Dates of recruitment were 9/2008 to 11/2011|There was no washout period. Patients receiving Niacin were excluded from the study.
745965|NCT00852930||
745966|NCT00852917||
745967|NCT00852761|Clinical research center|
745968|NCT00852644|9 patients were enrolled onto this study between January 2009 and August 2012 in the Radiation Oncology Clinic at Boston Medical Center|
745969|NCT00852631|Patients provide informed consent and are screened for eligibility (at Visit 1) up to 7 days before baseline assessment on Day 1.|On Day 1, baseline assessments will be performed, and patients will be assigned to Seroquel XR at 300 mg. On Day 2 all patients are assigned to reach target dose of Seroquel XR at 600 mg. Administration of study medication continue with Seroquel XR 600 mg daily until Day 42. Each visit will have ± 3 days window period.
745970|NCT00852592||
745971|NCT00852540||
745972|NCT00852527|456 participants were selected from three VA Polytrauma Network Sites and represent urban, suburban, and rural catchment areas. 438 completed all assessments necessary for analysis.|
745973|NCT00852475||
745974|NCT00852397||
745975|NCT00852241||
745976|NCT00852202||233 patients were randomized to receive double-blind treatment, 227 patients received at least 1 dose of double-blind treatment and were included in safety Population
745977|NCT00852137|"Study Period:
~First patient randomized: March 18, 2009 Last patient completed Day 57: May 27, 2009 A single site in the US"|
745978|NCT00852124|Participants were recruited between December 2010 and November 2012. Participants were recruited via flyers and newsletters.|
745979|NCT00851903|Among the 445 patients who completed the EASIE study, 194 had an endpoint Glycosylated Hemoglobin A1c (HbA1c) ≥ 7%. A total of 112 patients were included in the extension study: 37 uncontrolled on previous treatment with metformin and insulin glargine and 75 uncontrolled on previous treatment with metformin and sitagliptin in the EASIE study.|Among the 112 included patients, two patients prematurely discontinued from the study. One of them had continued his sitagliptin treatment but never started the insulin glargine treatment.
745980|NCT00851890||
745981|NCT00851877||
745982|NCT00851799|Consented and enrolled at AIDS clinical trials units in the United States. Enrollment occurred between June 1, 2009 (date first participant was enrolled) and April 13, 2011 (date last subject was enrolled).|334 consented and enrolled; 6 participants who initially enrolled were subsequently found ineligible and excluded from all analyses. Results reported for 328 eligible participants.
745983|NCT00851786|The first person was accrued on 04/29/2009. Accrual in the high CD4 stratum was closed in 02/2010 (n=203; 152 on ZOSTAVAX and 51 on placebo). Accrual to the low CD4 stratum proceeded more slowly with the last subject enrolled on 06/30/2011 (n=192; 144 on ZOSTAVAX and 48 on placebo). All 43 participating sites enrolled at least 1 subject.|Enrollment took place in two stages: Stage I were to enroll 48 subjects (24 in the low CD4 stratum and 24 in the high CD4 stratum). Subjects were randomized 3:1 to receive ZOSTAVAX or placebo. Stage II were to enroll approximately 352 subjects who would be randomized and stratified according to the same schedule.
745984|NCT00851747||
745985|NCT00851721|Enrollment was conducted in Europe, North America, Asia-Pacific, and South America at 17 clinical sites beginning in March 2009.|52 participants were enrolled. Sixteen participants discontinued, (ten were screen failures and six were withdrawn before randomization (2 sponsor's decision- inhibitors, 3 withdrew consent, and 1 due to investigator decision to have participant on prophylaxis). Therefore 36 participants were randomized.
745986|NCT00851682||
745987|NCT00851643|158 participants were enrolled. Of the enrolled 158 participants, 8 were screening failures. 150 participants were randomized to the base study (up to 12 months), conducted in 2 phases, Phase A and Phase B. Some participants continued in a voluntary, long-term extension of the study (up to 36 months).|In Phase A, participants were randomized to quadrivalent Human Papillomavirus (qHPV), Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS), or Octavalent HPV with 30 mcg IMX/AAHS. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.
745988|NCT00851630|Enrollment began in June 2004 and was completed in September 2005. Patients were enrolled at one of two hospitals in the Kilimanjaro Region of Tanzania.|
745989|NCT00851591|3 patients were recruited to participate. Recruitment was stopped due to a similar study had already been published and the inability to recruit patients.|
745990|NCT00851552||
745991|NCT00851409|"Patients with a history of frequent attacks, defined as HAE attacks occurring at least every two weeks were included in the study."|
745992|NCT00851357||
745993|NCT00851318|Patients with rheumatoid arthritis (RA) who participated in Study 275-08-001 (NCT00791999) were eligible for this study.|Participants were assigned to treatment groups based on whether they discontinued study 275-08-001 at Week 16 or completed Week 24 and based on American College of Rheumatology 20% (ACR20) response at Week 24.
745994|NCT00851279||
745995|NCT00851253|Participants were recruited from within the investigators clinic practice between February 2009 and August 2013|One subject that was enrolled onto the Boost Arm was withdrawn prior to undergoing cyberknife therapy due to disease progression.
745996|NCT00851084||There were 268 patients screened (informed consent signed) for this study. Of these screened patients, 236 patients were subsequently randomly assigned to treatments. 32 patients were screen failures.
745997|NCT00851006||
745998|NCT00850993|Fifty-eight (58) babies were enrolled before the trial was prematurely terminated due to cancellation.|Because the cohorts were run sequentially, and the trial was cancelled before they were all enrolled, Cohort 3 enrolled only 8 compared to 15 in Cohort 4.
745999|NCT00850889|Enrollment:32 Study Start Date: November 2008 Study Completion Date: February 2009 Primary Completion Date: November 2008|
746000|NCT00850759|recruitment from a variety of community sources between October 2009 and September 2011|9 excluded prior to group assignment, for these reasons: Not meeting inclusion criteria; child of incorrect age (n = 3) Not meeting inclusion criteria; child unable to understand protocol (n = 3) Did not complete baseline assessment (n = 3)
746001|NCT00850720||
746002|NCT00850642|The study was terminated prior to completion due to difficulties in recruiting the required participants. A total of 7 asthmatic participants completed the study prior to termination. The study was, conducted from 26 June 2009 to 02 June 2010, at three centers in Canada and three centers in the United Kingdom.|
746003|NCT00850603|Study participants were enrolled from 15 through 16 October 2002 in 1 US site|A total of 170 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
746004|NCT00850564|recruitment from March 2009 through March 2010|
746005|NCT00850538|Participants were recruited from 4 orthopedic surgeons at one hospital between the dates of March, 2009 and April, 2013.|
746006|NCT00850499||
746007|NCT00850473||
746008|NCT00850460|Advertisements were placed (internet, radio, print) and a screening phone questionnaire was administered by study staff to determine potential inclusion. A collaboration with the Metropolitan Hospital (NY) was also established for potential referrals.|Subjects in whom statins are possibly causative, using the World Health Organization (WHO)-Causality Assessment form, were invited to the outpatient clinic for 2 screening visits. Subjects found to be at high risk for cardiovascular events and those unwilling to be shifted to placebo were not enrolled.
746009|NCT00850421||
746010|NCT00850395||
746011|NCT00850343|Patients with rheumatoid arthritis (RA) who participated in Study 275-08-003 (NCT00791921) were eligible for this study.|Participants were assigned to treatment groups based on whether they discontinued study 275-08-003 at Week 16 or completed Week 24 and based on American College of Rheumatology 20% (ACR20) response at Week 24.
746012|NCT00850200||
746013|NCT00850174||
746014|NCT00850135||
746015|NCT00850096||
746016|NCT00850070|Recruitment spanned from 4/09 to 6/11. A variety of methods were used to advertise the study, but most successful recruitment was word-of-mouth from study participants.|Few participants were excluded. Most common exclusions were failure to meet inclusion criteria, mostly absence of an autism diagnosis or cognitive functioning below the required minimum.
746017|NCT00850031||119 participants were consented for the study (enrolled), and 118 subsequently were implanted with the device (started) for the study.
746018|NCT00849940||
746019|NCT00849901||This study consisted of a 10-week acute treatment phase, and a 6-month extension phase.
746020|NCT00849875||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the patients and signing informed consent forms.
746021|NCT00849862||
746022|NCT00849810|From 11/2008-4/2009, 472 patient were prescribed metoprolol succinate. During screening, metoprolol succinate was discontinued in 87 patients and 177 were excluded (obstacles to visits, competency issues). A national shortage of metoprolol succinate caused discontinuation in mant patients. One patient was enrolled and completed the study.|
746023|NCT00849797||
746024|NCT00849693||This study consisted of a 10-week acute treatment phase, and a 6-month extension phase.
746025|NCT00849680|317 participants were randomized. 2 did not receive any study medication. Therefore, the safety population was 315.|
746026|NCT00849524||
746027|NCT00849485||
746028|NCT00849472||
746029|NCT00849381|Subjects enrolled in this study were previously enrolled in the Control Group in the primary study (NCT00122681), where they had received Hepatitis A vaccination.|Results from one study center where compliance issues were discovered were presented both separately from the entire study cohort, as well as included in it. Out of the 1239 subjects enrolled in this study, 2 did not receive vaccination and were hence eliminated from the study.
746030|NCT00849290|Participants were registered between April 2004 and January 2009 across 52 clinical trial sites.|Participants who had objective disease progression on Dendreon's Phase 3 trial D9902B (NCT00065442)and who were determined to have received placebo were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
746031|NCT00849251||
746032|NCT00849212||
746033|NCT00849186||
746034|NCT00849147||
746035|NCT00849121|Subjects were enrolled between 3/16/2009 and 4/24/2012 and were recruited from the UW Carbone Cancer Center Clinics|
746036|NCT00849108|"Cohort 1 enrolled 33 patients across 3 clinical sites. Dosing for Cohort 1 was initiated January 2009.
~Cohort 2 enrolled 143 patients across 21 clinical sites. Dosing for Cohort 2 was initiated July 2009"|Cohort 1: Patients showing a mild to severe reversible perfusion defect on a qualifying SPECT MPI study were considered eligible for the study Cohort 2: Patients with known or suspected cornary artery disease who presented with a broad spectrum of pre-test likelihood of CAD(very low/low, to high likelihood)were considered eligible for the study.
746037|NCT00849056||Participants (par.) who met eligibility criteria and completed a 4-week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 450 par. were screened; 310 par. were randomized, and 301 par. received >=1 treatment dose.
746038|NCT00849017||Participants (par.) who met eligibility criteria and completed a 4 week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 479 par. were screened; 309 par. were randomized, and 301 par. received >=1 treatment dose.
746039|NCT00848965||Participants (par.) were randomized to receive treatment in one of five sequences in four study periods: ABCD, EABC, DEAB, CDEA, BCDE (A, Placebo; B, fluticasone propionate [FP] 25 micrograms [µg]: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). One par. randomized to ABCD withdrew due to an adverse event; one par. randomized to EABC withdrew consent.
746040|NCT00848926|Enrollment period: Feb 2009 - Aug 2009|
746041|NCT00848783|Between March 2008 and May 2010 eight patient were enrolled to the study from New York University Langone Medical Center and University of South California Cancer Center.|Patients were randomized to Arm A or Arm B after the response evaluation of the induction treatment. One patient was not randomized due to progression of disease before surgery and was taken off the protocol treatment.
746042|NCT00848744||
746043|NCT00848718|77 participants were allocated to one of 3 treatment combinations with MK-2206 according to clinical presentation but 5 participants were not treated due to disease progression before initiation of treatment.|
746044|NCT00848549|"E2090-E044-314 is a double-blind extension of E2090-E044-310 (NCT00477295) base study. Assessment of eligibility took place at the Study Entry Visit (SEV), which was the same day as their final visit of Study 310. Subjects remained on the same investigational product as they were randomized to in Study 310 until unblinding of that study."|
746045|NCT00848536|Patients were recruited from 30 study centers: 8 in the US, 6 in Mexico, 2 in Brazil, 4 in India, 2 in Australia, 2 in New Zealand, 2 in Latvia, and a single site in each: Taiwan, France, Belgium, and Italy.|
746046|NCT00848510|First/last participant (informed consent): Feb2009/Sep 2013. Study completion date: 28 Nov 2013. The study was conducted at 2 centers in United Kingdom and Spain.|Enrolled: 61 screened for eligibility; 20 excluded (mainly non-fulfillment of inclusion or exclusion criteria), 41 participants were enrolled into the study.
746047|NCT00848497|The study was approved for enrollment on 11/28/2007 and was closed on 1/25/13. Participants were consented in the Baylor Urology clinic setting.|
746048|NCT00848484|First Patient Evaluated: 14-Oct-2008, Last Patient Last Visit: 18-Jun-2009; 6 sites (2 United States, 4 Russia). In total, enrollment lasted approximately 8 months.|Patients in this cross-over study were randomly assigned to placebo or MK5757 for 2 weeks separated by a 2-week wash-out period. Women were not permitted to enroll into this study because safety, pharmacokinetic or pharmacodynamic properties of MK5757 in women have not been established.
746049|NCT00848393|A total of 51 study subjects completed the study.|Total number of subjects recruited was 52 patients (one enrollee withdrew prior to any study-related procedures) resulting in a total number of subjects participating of 51. The enrollee was withdrawn from the study after signing the consent and prior to enrolling to one of the arms of the study.
746740|NCT00818116|34 eligible patients were enrolled into the study|Open-label, single arm, non-randomized
746741|NCT00817999||
746050|NCT00848367|Participants were self-referred from advertisements distributed around Ottawa and surrounding area, or referred from the Regional Center for the Treatment of Eating Disorders at The Ottawa Hospital (Sept. 2007 to Mar.2009).|
746051|NCT00848354|The study consisted of 3 periods - Phase 1 (week 0-week 24), Phase 2 Year 1 (week 24-week 76), and Phase 2 Year 2 (week 76-week 128). 429 participants were randomly assigned to open label etanercept + methotrexate or open label conventional disease-modifying antirheumatic drug (DMARD) + methotrexate in a 2:1 allocation, respectively.|Five participants (etanercept + methotrexate: 3, DMARD + methotrexate: 2) were randomized but did not receive study treatment. These participants were either randomized in error or withdrew consent before receiving the first dose. Phase 1 DMARD therapy was either hydroxychloroquine (HCQ) or sulfsalazine (SSZ), as selected by the investigator.
746052|NCT00848250||29 participants were eligible, 8 refused participation
746053|NCT00848237||
746054|NCT00848211||
746055|NCT00848198|Subjects between the ages of 18 and 82 years were included in the study. Participants were chosen from 10 sites in the E.U. and U.S. from the general patient population. 314 total subjects were enrolled.|Of the first 314 subjects enrolled, only 299 (n = 218 female, n = 81 male), were used in the analysis with the remainder disqualified for incomplete case report forms and lack of data from the single visit.
746056|NCT00848185||
746057|NCT00848172|Subjects with a diagnosis of ET were recruited by referral from the Motor Control outpatient clinic, a listing on the NINDS web page, and from the general community.|29 subjects (12f, 17m) were screened for eligibility. 10 subjects were considered screening failures due to the following reasons: failure to confirm ET according to diagnostic consensus criteria (n=7), other medical conditions precluding a safe participation (n=2), or the lack of objective alcohol-response (n=1). Nineteen subjects were randomized.
746058|NCT00848120||
746059|NCT00848107|Subjects were recruited to enroll in 26 centers in the US, Canada, and the UK in this open-label trial within 14 days of completion of TDE-DU-201. Subjects who prematurely terminated the previous controlled trial were not eligible. Data from the final study visit of the previous trial served as Baseline data and subject blinding was maintained.|Eligible subjects who completed assessments for the final visit of the previous controlled trial, TDE-DU-201, were eligible to enroll in this extension study. Data from this final study visit served as Baseline data. A total of 115 subjects were enrolled, with 115 subjects receiving study medication at an initial dose of 0.25 mg twice daily (BID).
746060|NCT00848081||
746061|NCT00848042|Subjects screened and enrolled at four sites in the United States.|
746062|NCT00848016|This study opened on 3/17/2009 and accrued 29 participants before being permanently closed 8/03/2011.|All 29 participants are off treatment, and all participants are evaluable for response and for adverse responses.
746063|NCT00847938||
746064|NCT00847912||
746065|NCT00847886|This study was performed at one center in Dallas, TX. Recruitment began in January 2009 and the last subject completed the study in March 2009.|One subject did not complete the study due to an adverse event of uveitis on Day 1 and was not dosed with study drug. This subject was not included in any population analyses. Therefore, the participant flow includes 15 subjects, 12 receiving active drug and 3 receiving placebo.
746066|NCT00847808|Participants enrolled at 45 investigative sites in the United States from 10 February 2009 to 15 April 2010.|Participants with a diagnosis of gastroesophageal reflux disease, whose symptoms were well controlled on twice daily proton pump inhibitors, were enrolled in the study and received a once-daily (QD) dexlansoprazole modified release (MR) capsule in the morning and a matched placebo capsule in the evening.
746067|NCT00847730||
746068|NCT00847704||
746069|NCT00847665|A medical-surgical ICU of a university hospital. Patients were recruited from february 2009 to January 2011|A total of 512 patients with more than 24 hours of mechanical ventilation were screened. 55 patients were excluded because of the presence of pressure ulcer. Other 126 patients were excluded because of the presence of other exclusion criteria (age, pregnancy, refusal of consent,...)
746070|NCT00847626|Participants enrolled at 175 investigative sites in Austria, Chile, Germany, Guatemala, Mexico, Netherlands, Peru, Poland, Russian Federation and the United States from 29 January 2009 to 10 July 2010.|Participants with moderate to severe essential hypertension were enrolled in one of 11, once-daily (QD) treatment groups.
746071|NCT00847613||
746072|NCT00847587|Participants were recruited in the postpartum ward of the University of Utah hospital. Recruitment took place during 2009-2010.|Randomization occurred after consent. No participants were excluded from the trial after randomization.
746073|NCT00847561||
746074|NCT00847535||66 participants were biopsied, 64 participants received injections.
746075|NCT00847522||
746076|NCT00847509|A total of 49 patients were enrolled and 38 patients received investiational product.|
746077|NCT00847405||
746078|NCT00847379|A total of 173 participants were screened for eligibility to enter this extension study after completing the 48-week double-blind study PTC124-GD-007-DMD (NCT00592553). All participants met entry criteria and enrolled in this study.|Participants were categorized by the treatment group to which they had been randomly assigned in Study PTC124-GD-007-DMD (NCT00592553).
746079|NCT00847301|There were 472 patients entered into the study, 428 were treated with moderate renal impairment. Treated patients with moderate renal impairment are presented.|
746080|NCT00847288|The recruitment period of OptiVol Care Pathway Study was from April 2, 2009 to March 7, 2011.|There were 1682 enrollments from 106 study centers. 1668 of those enrollments met the inclusion criteria for the study and thus were randomized. Fourteen did not meet the inclusion criteria and were excluded before randomization.
746081|NCT00847210|Participants were enrolled at 3 investigative sites in the United States from 31 May 2009 to 10 September 2009.|Participants were enrolled in one of two, dexlansoprazole modified release (MR), once-daily (QD) treatment groups. 100% of participants randomized completed this study.
746082|NCT00847197|Participants were recruited at 26 sites in 8 different countries from February 2009 to August 2009.|Participants had a 2-week placebo run-in period prior to randomization. 402 participants were screened of which 211 participants were excluded (194 participants did not meet inclusion criteria, 15 participants withdrew, 1 participant was lost to follow-up and 1 participant had an adverse event).
746083|NCT00847171||
746084|NCT00847145|Subjects were enrolled at 15 sites in Finland, 12 sites in Germany, 5 sites in Austria, 27 sites in Czech Republic and 6 sites in Italy.|All enrolled subjects were included in the trial.
746085|NCT00847132||
746086|NCT00847015||
746087|NCT00847002|Study was stopped early due to slow accrual.|
746088|NCT00846885||
746089|NCT00846846|1018 patients were enrolled from February 2009 until November 2009 in 48 participating hospitals in USA.|Subjects were excluded from participation if they did not meet inclusion/exclusion criteria.
746090|NCT00846807|There were 5438 patients enrolled, 5292 were treated. Treated patients are presented.|Phase IV, open-label, prospective, observational, single-arm study on surgery patients (hip and knee surgery)
746091|NCT00846768||This was a multi-centre, randomised, double-blind, 4-way crossover trial. The duration of each treatment period was 3 weeks with no washout period between treatments.
746092|NCT00846742|88 participants were enrolled from 5 institutions between June 2009 and October 2018.|Two out of 88 enrolled patients are ineligible and were removed from the study. They were determined to be intermediate risk rather than low risk. One was taken off study after being re-consented on an expired consent and treated with cyclophosphamide instead of mechlorethamine; 1 patient withdrew from study but was evaluable for primary objective.
746093|NCT00846651|We applied for an IRB approval for 90 patients. The power analysis indicated that a minimum of 37 subjects for each group was needed. To allow for potential dropouts, we applied for 45 patient in each group. (total of 9O patients)|
746094|NCT00846586||
746095|NCT00846573|Recruitment began November 2008 and enrollment started January 2009. Recruitment continued until the study was terminated, April 2011. Participants were asthmatics, COPD patients, or CF patients as confirmed by their physician. Recruitment was completed from the UMass Memorial Medical Centre. Alternatively, healthy volunteers were also recruited.|Participants were excluded if their diagnosis of a lung condition could not be confirmed by medical records.
746096|NCT00846547||
746097|NCT00846521||
746098|NCT00846495||
746099|NCT00846482||
746100|NCT00846391|"First Patient In:10-Feb-2009
~Early Termination*:11-Aug-2009
~Last Patient Last Visit:19-Aug-2009
~10 Centers Worldwide
~*Study was terminated due to inability to recruit patients. Because it was not terminated for safety concerns, sites were to see patients for early termination visit at earliest convenience. The last patient was seen 19-Aug-2009."|Patients 18-65 yrs not on antihyperglycemic agent (AHA) (A1C 7-10%),or single AHA (A1C 7-9.5%),or low dose dual AHA therapy (A1C 6.5-9.5%) with type 2 diabetes mellitus entered a 4-wk diet/exercise period (AHA wash-off if on AHA),after which,those with fasting glucose of 130-250 mg/dL were eligible for randomization (after a 2 wk pbo run-in period)
746101|NCT00846365|Participants enrolled at 93 investigative sites in Argentina, Chile, Mexico and the United States from 13 March 2009 to 25 June 2010.|Participants with moderate to severe essential hypertension were enrolled in one of 3, once-daily (QD) treatment groups.
746102|NCT00846287|Patients with moderate to severe COPD were recruited and enrolled from the UMass Lung and Allergy Center from November 2008 to April 2011.|
746103|NCT00846066|All Pediatric residents, in the Continuity Clinic Rotation (CCC) at a general pediatric ambulatory clinic, in an urban tertiary care children's hospital, were invited to participate. Residents in any year of training were considered eligible for the study, recruitment took place in January, 2007|59 participants were evaluated for the pre-test knowledge, they were next administered the Web Based Training and were then evaluated for the post-test knowledge. 56 participants were then randomized into two groups, 3 were excluded, (2 refused consent and 1 deviated from the protocol).
746104|NCT00846053|January 2009-December 2012, St. Louis Children's Hospital Cystic Fibrosis Clinics (St. Louis)|
746105|NCT00846027||
746106|NCT00845975|18 subjects were recruited and enrolled in this study between August 26, 2008 and September 16, 2008 at a single medical hearing aid clinic.|There were no significant events or approaches for the overall study following participant enrollment, but prior to group assignment. There were no enrolled participants excluded from the trial before assignment to groups.
746107|NCT00845897||
746108|NCT00845858||
746109|NCT00845845|Twelve (12) individuals consented and were screened and nine (9) were randomized between March 2006 and June 2009. Due to low enrollment, the study was terminated in October 2010. Participants were recruited by study staff at outpatient clinics at The University of Illinois Chicago Hospitals and Clinics (UIHC).|A screening evaluation was used prior to group assignment to evaluate whether patients were affected by nonalcoholic steatohepatitis (NASH) and to evaluate the inclusion and exclusion criteria.
746110|NCT00845832||
746111|NCT00845728|3,444 patients were randomized, but only 3,439 received treatment as 5 patients were mis-randomized.|
746112|NCT00845702|First Patient First Visit: Apr 2009 Last Patient Last Visit: Feb 2010 Location: Radiology centers|Out of the 33 enrolled patients, one patient did not undergo any of the planned procedures due to an inability to obtain an intravenous access with the initial planned procedure.
746113|NCT00845676|All participants were enrolled at one U.S. clinical site|
746114|NCT00845663|In total 159 subjects have been screened. Participant Flow presents all subjects randomized. Intent-to-treat and Safety population are identical to randomized population.|
746115|NCT00845650||
746116|NCT00845520||
746117|NCT00845507||
746118|NCT00845481||
746119|NCT00845429|Participants were enrolled from 16 to 23 October 2007 in 15 clinical centers in the US.|A total of 729 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
746120|NCT00845195|March 8, 2009 - April 22, 2009|
746121|NCT00845182||
746122|NCT00845130||All subjects were consented to participate in the study. After baseline information was gathered from labs, it was determined that seven subjects did not meet the inclusion criteria. They were excluded from completing the study.
746123|NCT00845065|A total of 202 participants were randomized but 1 participant was not treated.|
746124|NCT00845039||
746125|NCT00845000||
746126|NCT00844896|Children aged 0-5 years who were hospitalized for an acute or reconstructive burn injury and their families were eligible for participation in the study. Recruitment for the study occurred from May 2008-August 2010.|
746127|NCT00844883|This study enrolled patients diagnosed with unresectable hepatocellular carcinoma who were eligible to receive a combination therapy of sorafenib and transarterial chemoembolization. Enrollment took place from 3/2009 to 12/2011 at Johns Hopkins Hospital.|90 patients consented and screened for study. 38 were ineligible and 2 later declined participation.
746128|NCT00844857||
746129|NCT00844844|C08-002A/B combined 2 studies: one for adults (C08-002A, N=16) and one for adolescents (C08-002B, N=1) Please refer to NCT00844545 for combined studies with enrollment number corresponding to each individual study|Patients had to exhibit a decrease in platelet count despite at least 4 Plasma Therapy (PT) treatments in the 1 week immediately prior to screening. Patients who met the eligibility criteria during screening were enrolled into the Treatment Period which commenced with the first eculizumab dose.
746130|NCT00844831|Subjects recruited from outpatient clinics and advertisement|Study consisted of a 4-week run-in period to wash out prior therapy for constipation. Subjects may withdraw if they can not stay off their medications for constipation.
746131|NCT00844805||
746132|NCT00844753|200 participants were screened. 131 passed screening. Participants failed screening for the following reasons: 16 Attention Deficit Hyperactivity Disorder (ADHD) not confirmed, 23 Autism Spectrum Disorder not confirmed, 7 previous parent therapy or mental age too low, 23 for other reasons.|Two participants who passed screening withdrew and one child became ineligible because of ADHD severity declining at baseline.
746133|NCT00844714||
746134|NCT00844649|Participants were randomized in a 1:1 ratio and the randomization was stratified by geographic region (Australia versus Eastern Europe versus Western Europe versus North America), Karnofsky performance status (70 to 80 versus 90 to 100), and by the presence of liver metastases (yes versus no)|38 participants were randomized but not treated due to the participants request to withdraw after the randomization results became known. 1 participant was randomized to Gemcitabine and was treated with Albumin-bound paclitaxel ABI-007/Gemcitabine in error and analyzed as treated and included in the intent to treat population (ITT)
746135|NCT00844597||
746136|NCT00844558||
746137|NCT00844545|C08-002A/B combined 2 studies: one for adults (C08-002A, N=16) and one for adolescents (C08-002B, N=1) Please refer to NCT00844844 for combined studies with enrollment number corresponding to each individual study|Patients had to exhibit a decrease in platelet count despite at least 4 Plasma Therapy (PT) treatments in the 1 week immediately prior to screening. Patients who met the eligibility criteria during screening were enrolled into the Treatment Period which commenced with the first eculizumab dose.
746138|NCT00844532|Trial population is comprised of male and female subjects with moderate to severe iliac artery atherosclerotic occlusive disease. Recruitment dates: March 23, 2009 through May 17, 2010|
746139|NCT00844519||
746140|NCT00844480||
746141|NCT00844428|C08-003A/B combined 2 studies: one for adults (C08-003A, N=15) and one for adolescents (C08-003B, N=5) Please refer to NCT008838513 for combined studies with enrollment number corresponding to each individual study|Patients receiving PT for aHUS and observed to receive ≥ 1 PT every two weeks, and no more than 3 PT treatments/week for at least 8 weeks before the first dose of eculizumab. Patients who met the eligibility criteria during the Observation Period were enrolled into the Treatment Period which commenced with the first eculizumab dose.
746142|NCT00844415||
746143|NCT00844376|One center in the U.S.|This study contained two sequences of 6 subjects per sequence. Each sequence received either test treatment followed by reference treatment, or reference treatment followed by test treatment. The order of administration was randomized to either of 2 sequences.
746144|NCT00844298||
746145|NCT00844194||
746146|NCT00844090|recruitment period Oct 2009- Jan 2012.Participants recruited from Omaha VA outpatient clinics|All participants underwent a stress echo after consent. If stress echo was positive patient was not assigned to randomized arms
746147|NCT00844051||
746148|NCT00843986||
746149|NCT00843856||
746150|NCT00843843||
746151|NCT00843830||
746152|NCT00843778|Subjects must have either failed to achieve remission in C87076 [NCT00674362] at Week 20 and/or Week 24 (CDAI >2.8), which was confirmed at Week 24, or must have achieved remission at Week 20, which was confirmed at Week 24, flared up between Week 24 and Week 52 and completed the entire C87076 study through Week 52.|Participant Flow refers to the Enrolled Set consisting of all subjects who gave informed consent.
746153|NCT00843713||
746154|NCT00843635||
746155|NCT00843622|Participants recruited from database of clinical trial volunteers, and media ads|Participants were checked for eligibility prior to group assignment
746156|NCT00843531||
746157|NCT00843518||Study Period 1 lasted 3 to 28 days and included screening tests and procedures (N=205). Study Period 2 was a 12-week, randomized, double-blind treatment period with clinic visits at 3-week intervals and intervening weekly telephone assessments with caregivers (N=132). Study Period 3 was a 1-week, single-blind washout period (N=91).
746158|NCT00843492||
746159|NCT00843479|The recruitment process took place at the Laboratory of Investigation on Metabolism and Diabetes - LIMED, located at the Medical School of the State University of Campinas (UNICAMP).|Cross-sectional study conducted with 24 non-obese patients with normal glucose tolerance. Two groups formed: middle-aged (n=12) and aged(n=12). They were healthy and had no significant illness. None were taking drugs that affect insulin sensitivity/secretion or incretin hormones.
746160|NCT00843466|Recruitment was from May 22,2007 to May 12, 2008 at Wake Forest University in Winston Salem.|
746161|NCT00843349|Participants in the study were enrolled between July 2009 and November 2011. Study team members identified potential participants from outpatient clinics at the University of Miami Nephrology Clinics and Jackson Health System Nephrology Clinics.|After screening, the patients underwent a two-week run-in period encompassing three separate visits during which baseline blood and urine were collected, as well as baseline nutrition information.
746162|NCT00843310|Patients were enrolled from NYU medical center and its affiliated hospitals from Dec 2008 through Apr 2011.|Total 8 patients were enrolled. One patient withdrew before the treatment started.
746279|NCT00837590|All subjects were self-referred to the clinic for this study.|Subjects were excluded primarily for anemia based on screening labs or failure to return for clinic visits.
746280|NCT00837577||
746163|NCT00843284|The study was conducted at 23 sites in Greece by investigators contracted by and under the direction of the sponsor. This study was performed by office-based physicians and in hospitals.|This study enrolled subjects with a confirmed diagnosis of neuropathic pain, according to the neuropathic pain diagnostic (DN4) Questionnaire, completed by the investigator at baseline
746164|NCT00843193|The study was conducted in participants with severe asthmatics from 9-Dec-2008 to 19-July-2010 at 35 study centers in France (7), United States (6), United Kingdom (5), Poland (5), South Africa (4), Germany (3), Netherlands (3) and Norway (2).|During run-in period of 28 days each participant's inhaled corticosteroid (ICS) dose was up-titrated to 1000 microgram (μg)/day fluticasone propionate. Participants already taking ≥ 1000 µg/day fluticasone propionate or equivalent prior to study remained on their pre-study dose. Total of 198 participants were randomized and treated in the study.
746165|NCT00843180|November 2008-November 2009, 12 months UCSF Children's Hospital, Bone Marrow Transplant Unit|consecutive enrollment of all eligible admitted children. 2 teenage boys declined participation
746166|NCT00843167|This clinical trial was conducted between 12/23/2008 to 3/27/2013 at Oregon Health and Science University's (OHSU) Center for Women's Health Breast Center in Portland, OR. English-speaking women were recruited to participate in the study based on the following inclusion criteria: ≥ 21 years, diagnostic mammogram with results that require biopsy.|
746167|NCT00843115|This was a non interventional study conducted at 62 sites in Canada.|Subjects had a diagnosis of mild to moderate Alzheimer's Disease with or without other etiologies of dementia.
746168|NCT00843050|This study was conducted across multiple centers in the United States and India.|
746169|NCT00843024||
746170|NCT00842985||
746171|NCT00842946||
746172|NCT00842829|A total of 442 patients already receiving opioid maintenance therapy for chronic cancer pain and experiencing up to 4 BTP episodes per 24 hours (on average) were screened at 135 centers in 7 European countries.|
746173|NCT00842764||
746174|NCT00842751|Men age 18-52 in good health were recruited through local newspapers and college campus flyers.|12 subjects were screened; 11 enrolled (1 did not meet inclusion criteria-abnormal liver function test at baseline and excessive alcohol use). Each subject was administered each of the three treatments over a 6-week period with 1 week of no treatment (wash-out) between each of the treatment period.
746175|NCT00842712|First/last participant (informed consent): Feb 2009/Jun 2012. Clinical data cut-off: 26 Jun 2013, Study completion date: July 2013.|In safety run-in part of study, a total of 12 participants were enrolled and treated. In randomized part of study, 220 participants were enrolled and out of these 220 participants, 215 were treated.
746176|NCT00842608||551 patients were consented into the study. After completing the consent and randomization, 6 patients withdrew from the study and were included in intention-to-treat analysis. 545 patients completed the protocol.
746177|NCT00842543|Participants recruited from pediatric endocrinology clinics, in Jacksonville, USA between July 2008 and December 2009.|Of the 246 children screened for eligibility, 74 did not meet criteria, 35 refused to participate, 98 were not randomized for various reasons, 39 were randomized.
746178|NCT00842530|Study participants were enrolled from 05 February 2009 to 05 February 2010 at 1 clinical site in Thailand. A total of 4002 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized; however, only 3997 participants received the first vaccination.|Two-step enrollment approach was followed. Cohort 1 (100 participants [CYD vaccine arm] received CYD vaccine as Injection [Inj.] 1 and 50 [control group arm] received rabies vaccine as Inj. 1) was enrolled first. After 14 days review of Cohort 1 safety data in both arms, cohort 2 was enrolled (2569 participants in CYD group; 1283 in control group).
746179|NCT00842361|A total of 8 sites in Japan|
746180|NCT00842348|There were 26 active sites across 10 countries in Study 729; however, only 24 recruited patients. The study was initiated in February 2009 and was completed in December 2015.|
746181|NCT00842335|This study was conducted at one clinical site in the US. First Patient Enrolled: 24 February 2009 Cut-off Date: 15 February 2011|
746182|NCT00842309||68 participants consented and screened. Of those, 28 were deemed eligible to participate and randomized to a condition. The remaining 40 participants were excluded for the following reasons: Did not meet criteria (n= 30) Declined to participate (n= 4) Did not show (n= 3) Other (n= 3)
746183|NCT00842296|Recruitment from April 24, 2006- September 5, 2006. Medical offices/clinics and university hospital.|
746184|NCT00842257|Subjects identified by their treating oncologist in the Gastrointestinal Cancer Clinics at Massachusetts General Hospital and Dana-Farber Cancer Institute, all therapy options are discussed (including participation in this trial).|
746185|NCT00842244||
746186|NCT00842231||
746187|NCT00842153||A wash-out period of 2 to 8 weeks, the duration of which varied by specific medication, was required prior to Visit 1.
746188|NCT00842075|10 subjects recruited and completed|no comments
746189|NCT00842023||
746190|NCT00841971||
746191|NCT00841906||
746192|NCT00841828||
746193|NCT00841815||
746194|NCT00841776|Clinical research center|
746195|NCT00841763|Subjects were enrolled from 27 centers across Finland and Germany|All subjects enrolled were included in the trial.
746196|NCT00841698||
746197|NCT00841672||
746198|NCT00841659||
746199|NCT00841568||
746200|NCT00841555|Patients were enrolled between 2009 and 2012|
746201|NCT00841542||
746202|NCT00841412||
746203|NCT00841321|Study sites were the Portland VA Medical Center, Portland, Oregon & VA Puget Sound Health Care System, Seattle Washington. Enrollment time span was January 2009 to November 2010.|A total of 172 people were assessed for eligibility and 52 did not meet criteria for randomization. Reasons for exclusion included cognitive scores too high (35), Beck Depression Inventory II scores too high (7), failed color vision test(4), usage of contraindicated medications (2); miscellaneous reasons (4).
746204|NCT00841269|Participants were recruited via clinician referrals and IRB-approved recruitment materials and advertising.|
746205|NCT00841204||
746332|NCT00835614||
746333|NCT00835588||
746334|NCT00835575||
746206|NCT00841100|All participants enrolled in the acute phase were eligible to continue onto the Phase 1 component of the trial. Only the participants who were non-responsive on the Phase 1 component of the study continued on to Phase 2. Only Phase 2 participants who achieved a fasting blood phenylalanine of less than 600 umol/l can continue to Phase 3.|
746207|NCT00841087|A total of 8 sites in Japan|The period between the Visit 1 (screening visit) and Visit 2 (baseline visit) of 3 weeks [±7 days] was the run-in period. The subjects continued their insulin treatment (basal-bolus therapy: insulin glargine or neutral protamine Hagedorn (intermediate-acting insulin) [NPH] insulin) same as their pre-trial dose.
746208|NCT00841035||
746209|NCT00840996|With approval of the institutional review board at the Cleveland Clinic and written informed consent, between September 2009 to October 2011 we enrolled 116 patients to undergo elective multi-level spine surgery At Cleveland Clinic, Cleveland, Ohio, USA .|
746210|NCT00840970||
746211|NCT00840879||
746212|NCT00840866||
746213|NCT00840840||
746214|NCT00840827||
746215|NCT00840749||
746216|NCT00840658|"Study recruitment took place between October 28, 2008 through May 31, 2010 in Tijuana and November 15, 2008 through July 30, 2010 in Ciudad Juarez.
~Data Collection for this study has been completed and the study is in the analysis phase."|Targeted sampling techniques were used. Potential participants were approached at venues such as motels, hotels, brothels, shooting galleries, bars, alleys and street corners in both cities. Interested parties were referred to the project offices or a mobile unit for eligibility screening.
746217|NCT00840632||
746218|NCT00840476||
746219|NCT00840463|Recruitment occurred through the UTSW clinics. Recruitment difficulties arose and the study was halted due to poor recruitment|
746220|NCT00840450|14 patients were enrolled into this study from April 2007 to August 2009 from New York University medical center and affiliated hospitals. Only 12 were evaluable since 2 patients never received treatment because of rapid symptomatic deterioration.|
746221|NCT00840411||
746222|NCT00840307||
746223|NCT00840294||
746224|NCT00840281||
746225|NCT00840216||
746226|NCT00840203||
746227|NCT00840177||
746228|NCT00840099||
746229|NCT00840086|The patients were recruited at 48 sites in 15 countries: Republic of Serbia (5), Turkey (5), Germany (4), Japan (8), the United Kingdom (3) and the United States of America (10). Two sites each in Brazil, Italy, Spain and Croatia. One site each in Switzerland, Taiwan, Israel, Malaysia and Russian Federation.|
746230|NCT00840073||
746231|NCT00840060|Children were recruited at three public school sites. From January 2009 to May 2010, 50 participants were successfully recruited. Of the 50, 40 met inclusion criteria and were randomly assigned to one of the two treatments.|No participants were excluded from the treatment following enrollment.
746232|NCT00840034||In the Acute Treatment Phase participants are randomized to either LY2216684 or placebo treatment groups. Participants who complete the Acute Treatment Phase or discontinue early after 4 or more weeks in the Acute Treatment phase are eligible to participate in the 2 week Taper Phase, but not all elected to participate.
746233|NCT00839982||
746234|NCT00839956||
746235|NCT00839930||
746236|NCT00839917|The study was planned to enroll 360 participants; however the study was terminated early because it was not possible to complete enrollment before expiration of the investigational vaccine lot|
746237|NCT00839852|"The Enrolled Population consisted of 97 participants who completed the lead-in study, RGH-MD-16, and signed an informed consent form to continue in this extension study.
~The Safety Population consisted of 93 participants from the Enrolled Population who took at least 1 dose of cariprazine in this extension study."|The study was designed as a one-arm study where patients were not randomized or analyzed by dose, rather they were flexibly dosed with Cariprazine 1.5, 3.0, or 4.5 mg/day via oral administration. The starting dose of 1.5 mg/day was titrated as needed within the range of 1.5-4.5 mg/d based on investigator's judgment of response and tolerability.
746238|NCT00839800|The first participant entered the study on 16 February 2009, and the last participant completed the study on 23 February 2011. A total of 3209 participants were enrolled at 148 centres in 13 countries in Asia, America and Europe, and 2091 participants who fulfilled the randomisation criteria were randomised.|The study started with an enrolment visit, Visit 1, 1-7 days prior to Visit 2 (run-in). At Visit 2 patients had to have a reversibility of ≥12% relative to baseline and their pre-bronchodilatory Forced expiratory volume in one second (FEV1) had to be ≥50% of the predicted normal value.
746239|NCT00839540|Subjects were inpatients (Sparrow Hospital) with probable fungal infections that required treatment with an antifungal; referral base was infectious disease consultations. The first subject was enrolled 12/24/08, with the last subject enrolled on 1/15/10.|
746240|NCT00839527||Participants (par.) who met eligibility criteria and completed a 6- to 8-week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 992 par. were screened; 685 par. were randomized, and 663 par. received >=1 treatment dose.
746241|NCT00839436||
746242|NCT00839423|Outpatients with Major Depressive Episode (MDE) were recruited from psychiatric settings.|Eligible patients were randomised equally (1:1:1:1) to one of the 4 treatment arms for a 6-week double-blind treatment period. The doses of Vortioxetine were 5 mg/day or 10 mg/day for 6 weeks. The dose of venlafaxine was 75 mg/day for 4 days, 150 mg/day for the following 3 days, and 225 mg/day for the remainder of the treatment period.
746243|NCT00839332||
746244|NCT00839319|Subjects were recruited using rosters from prior research studies and newspaper and online advertisements.|2 of 61 men decided not to enroll. 19 failed inclusion criteria, 1 withdrew consent before study procedures, 1 dropped out after Day 1, and 1 was withdrawn by the investigator for syncopal reaction. 6 did not suppress serum luteinizing hormone(affecting intratesticular testosterone)and were excluded from analysis. 31 completed the study.
746245|NCT00839306|Participants were eligible for this study if they had completed one of the healing studies (E3810-G000-302 or E3810-G000-303), had no evidence of oesophageal erosions, had sustained heartburn resolution, and had no record of any serious adverse event (SAE) related to study medication during the healing study.|Out of 240 participants who were randomized in this study, 237 participants received study treatment.
746246|NCT00839254|This study is linked with 10PN-PD-DIT-043 (111442) study (NCT00861380.-EudraCT: 2008-005149-48) with which primary objectives and outcomes are common. Subjects of 10PN-PD-DIT-043 study contributed to the results of this study.|Out of 6183 subjects enrolled, 6177 were analyzed:(6174 subjects and 3 of them received 2 subject numbers, without any impact on the results of the analyses. Total population assessed for combined analyses performed on both studies included 45977 subjects, see details in groups description.
746247|NCT00839241||
746248|NCT00839098||
746249|NCT00839072||
746250|NCT00838981|Adult male and female participants were recruited from the Greater New Haven area from May 2008 to March 2014 by word-of-mouth, flyers and from referrals from treatment centers in the local area. The study was conducted in an outpatient clinic of the West Haven VA Hospital.|"After eligibility was determined, participants were randomized to placebo, 200mg up to 400mg of modafinil.The study consisted of three phases that involve: 1) a one or two week induction phase, 2) an eleven-week treatment phase; and 3) a four week taper, detoxification or transfer phase."
746251|NCT00838929||
746252|NCT00838916||Participants (par.) who met eligibility criteria and completed a 4 week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 1060 par. were screened; 779 par. were randomized, and 745 par. received >=1 treatment dose.
746253|NCT00838903||Eligible participants (par.) entered a 2-week Screening Period, a 4-week Run-in/Stabilization Period, a 156-week Treatment Period, and a 8-week post-treatment Follow-up Period. A total of 1525 par. were screened, 1049 were randomized and 1012 par. received at least 1 dose of study treatment.
746254|NCT00838695|Subjects were recruited by advertisement within the Vanderbilt University campus and through the Vanderbilt University Clinical Research Center study volunteer database,|
746255|NCT00838682|"Location: Uijeongbu St. Mary's hospital and Bucheon St. Mary's hospital, The Catholic University of Korea
~Period: from April 1, 2006 to April 19, 2007 and from October 1, 2007 to December 31, 2008."|Patients who presented with overt or suspected upper gastrointestinal bleeding were eligible. These eligible patients were required to have an high-risk bleeding peptic ulcer on emergent endoscopy performed within 24 hours after the hospitalization. Among those, patients who achieved primary hemostasis with endoscopic hemostatic treatment.
746256|NCT00838630||
746257|NCT00838578||
746258|NCT00838565||
746259|NCT00838539||
746260|NCT00838526|Participants were eligible for this study if they had completed one of the healing studies (E3810-G000-301 or E3810-G000-303), had no evidence of oesophageal erosions, had sustained heartburn resolution, and had no record of any serious adverse event (SAE) related to study medication during the healing study.|Out of the 240 participants who were randomized in this study, 235 participants received study treatment.
746261|NCT00838513|C08-003A/B combined 2 studies: one for adults (C08-003A, N=15) and one for adolescents (C08-003B, N=5) Please refer to NCT00844428 for combined studies with enrollment number corresponding to each individual study|Patients receiving PT for aHUS and observed to receive ≥ 1 PT every two weeks, and no more than 3 PT treatments/week for at least 8 weeks before the first dose of eculizumab. Patients who met the eligibility criteria during the Observation Period were enrolled into the Treatment Period which commenced with the first eculizumab dose.
746262|NCT00838435|This was a multicenter study conducted at 20 sites in the U.S. and Canada.|
746263|NCT00838331||Seven subjects withdrew prior to transfusion.
746264|NCT00838279||
746265|NCT00838201|First subject enrollment date: 18 February 2009; Last subject enrollment date: 11 May 2010|Only recruited those who were participating in the safety follow-up of 20040138 study at the time, were willing to receive Denosumab, and met the inclusion/exclusion criteria. The first portion of the arm label indicates subjects' treatment groups (Placebo or Denosumab) in the parent study 20040138
746266|NCT00838162|This study was conducted in Germany.|In total, 41 participants were screened of whom 33 participants were randomized and treated with TMC310911. All treated participants completed the study; there were no dropouts or discontinuations during the study.
746267|NCT00838136||
746268|NCT00838110||
746269|NCT00838097|First participant was enrolled on 26 February 2008; last participant was enrolled on 24 February 2011.|
746270|NCT00838006||426 soldiers were enrolled and completed the pre-deployment assessment. Fo these, 342 were randomized and had at least one follow-up assessment.
746271|NCT00837967|Patients recruited from 2 hospitals in Japan between January 2009 and July 2009. 28 patients enrolled; 25 patients randomized, 3 patients were not randomized (1 due to incorrect enrollment and 2 due to adverse event)|
746272|NCT00837902||
746273|NCT00837876|This study enrolled patients from October 2008 until February 2011.|37 patients consented and went on study. Six patients were ineligible.
746274|NCT00837824||Because the study was ended early only 20 patients from 9 sites were randomized into this study using a 1:1 randomization scheme to receive biweekly infusions of either 1 mg/kg (11 patients) or 3 mg/kg (9 patients) of Fabrazyme.
746275|NCT00837811||After ≥3 months treatment, investigator could choose 1-time dose increase [120 milligrams (mg) LY2127399 (LY)] for participants (pts) with ≥4 tender and ≥4 swollen joints. Additionally, 1-time dose decrease back to 60 mg LY permitted. Pts completing Week 72 completed study, but could be followed beyond Week 72 for B cell recovery (up to Week 112).
746276|NCT00837759||
746277|NCT00837694|Women were recruited from flyers poster around campus. Interested participants called the lab and were screened by telephone.|Exclusionary criteria included smoking, current dieting, medications that could affect appetite, medical conditions that limited physical activity, allergies to or self-reported dislike of study foods.
746278|NCT00837616|Forty-one girls with Turner Syndrome (45X and related karyotypes), between 13 and 20 years were recruited and followed among the 3 participating centers at the Nemours Children's Clinic, Jacksonville (coordinating center), Nemours Jefferson, and Clínica las Condes/University of Chile, Santiago, Chile.|Any previous growth hormone (GH) therapy was discontinued at least 6 months prior to study participation. Estrogen replacement therapy was discontinued for at least 6 weeks prior to baseline studies. Subjects with significant obesity (BMI > 36 kg/m2) or history of systemic illness were excluded.
746335|NCT00835549||
746336|NCT00835536||
746281|NCT00837512|Subjects were recruited from our outpatient clinic setting within the Emory Children's Center|In the event that the potential subject was on Humalog they switched to Novolog 48 hours prior to first visit.
746282|NCT00837486||
746283|NCT00837473||
746284|NCT00837447||
746285|NCT00837434|Participants were to be recruited from seven sites in the United States. Recruitment occurred at six sites. The first site was activated in April 2009. The first participant was randomized in July 2009 and the last participant was randomized in July 2013.|
746286|NCT00837330|Twenty subjects from one site in the United States will be enrolled. Subjects with active, exudative-PCV who have provided informed consent will be eligible. Date of first subject enrolled: May 19, 2006. Date of last subject enrolled: October 8, 2008.|
746287|NCT00837252||
746288|NCT00837213|"Recruitment period: First Subject Enrolled May 2008, Last Subject completed August 28, 2008.
~Types of location: Dermatology Research Center"|
746289|NCT00837200||
746290|NCT00837161|The first High Intensity Focused Ultrasound (HIFU) treatment was on February 8, 2009 and the last patient was treated on March 5, 2010. 2 study sites enrolled patients, 2 from St. Lukes in Houston, TX and 9 from National Institutes of Health in Bethesda, MD.|Patients were screened prior to treatment and the primary exclusion criteria was either uterine size per gestational age or fibroid size.
746291|NCT00837148||
746292|NCT00837096||
746293|NCT00837031||
746294|NCT00836953|The study participants were enrolled from 11 through 25 September 2003 in 1 US site.|A total of 33 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
746295|NCT00836927|Participants who continued to receive clinical benefit from ridaforolimus, or who were being followed for long-term safety and efficacy under the following prior protocols were eligible for enrollment into this extension study: MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054.|Participants may have continued ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
746296|NCT00836901||
746297|NCT00836888||
746298|NCT00836875||
746299|NCT00836810|Of 35 sequential eligible patients invited to participate 12 agreed to do so.|One patient was a technical failure (unable to take 24 hour blood samples) before the treatment randomisation step, leaving 11 patients included.
746300|NCT00836758|A total of 148 (PSGs and overnights with PAP therapy), collected from 115 unique participants, were included in this analysis.|"119 studies had a technically adequate recording and were collected from 90 patients (29 patients participated in two studies).
~These 119 studies were pooled with another 29 studies from another trial for a total of 148 studies. 4 patients participated in both trials and 3 of these patients contributed two recordings."
746301|NCT00836745||
746302|NCT00836719|Recruitment started in 9/2009 and ended 4/2010. Subjects were recruited from the LSU MS Clinic and from the community. Advertisements were placed in the quarterly MS Society newsletter and email list.|
746303|NCT00836706||
746304|NCT00836693||
746305|NCT00836641|11/2005-09/07: 70 outpatients (2-5-yo)with >3 asthma episodes during 12 months. Exclusion: pneumococcal immunization,severe/unstable asthma, systemic steroids, preterm birth (<37 weeks of gestation), low birthweight (<2500 g), major congenital abnormalities, and known intolerance towards ingredients of the pneumococcal vaccines.|
746306|NCT00836589||
746307|NCT00836498|Enrollment of participants occurred at 8 study sites in the United States.|Part II was not conducted; no participants were recruited.
746308|NCT00836472||
746309|NCT00836433||
746310|NCT00836407||
746311|NCT00836355||
746312|NCT00836342|Recruitment occurred from May 2009 to December 2011. Subjects were recruited from dermatology medical and surgery clinics at the Massachusetts General Hospital.|Patients were enrolled in the study if they had a history of cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma but were excluded if they had a history of both basal cell carcinoma and squamous cell carcinoma. Participants were also excluded if they were using retinoids or taking a multivitamin regularly for less than 5 yrs.
746313|NCT00836277||
746314|NCT00836186||
746315|NCT00836095||
746316|NCT00836056||
746317|NCT00836017||
746318|NCT00836004||
746319|NCT00835991||
746320|NCT00835978|This study was conducted at 49 centers in Czech Republic, Germany, Japan, Russian Federation, Spain, and the United States (US).|Participants were enrolled in a 4-week lead-in period, during which they received axitinib 5 milligram (mg) twice a day (BID). After the lead-in period, participants meeting randomization criteria were then randomized to one of the two treatment arms. Participants, not meeting criteria, continued study without dose titration (non-randomized arm).
746321|NCT00835926|Participants were enrolled and treated from 25 July 2003 to 26 August 2003 at 1 US site.|A total of 121 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
746322|NCT00835900||
746323|NCT00835861|Recruitment occurred at two hospitals from July 2008 through March 2010 at one and from January 2009 through December 2009 at the other.|
746324|NCT00835796||
746325|NCT00835770|Participants were enrolled at 298 investigative sites from 03 February 2009 to 08 November 2019.|The study included participants who completed studies NCT00420212 and NCT00451451. A total of 1736 participants were treated in the open label phase extension study NCT00835770, out of which 759 completed the study.
746326|NCT00835731|Dates of recruitment period: January 2009 - December 2011 We recruited English- or Spanish-speaking women who were in good health, at least 18 years old, and between 12 weeks 0 days and 15 weeks 0 days gestation by ultrasound examination, seeking outpatient pregnancy termination at Planned Parenthood League of MA.|Patients were recruited for study participation on the day of their pregnancy termination procedure. All study procedures occurred on the day that the patient was enrolled.
746327|NCT00835705||
746328|NCT00835692||
746329|NCT00835679|This study was open to accrual from December 2009 to August 2011.|Eleven patients consented, with two ineligible. The study closed prematurely due to slow accrual.
746330|NCT00835666||
746331|NCT00835640||
746337|NCT00835510|Patients 12 years of age and older, who presented with interdigital tinea pedis, with a positive potassium hydroxide test (KOH) and met the inclusion/exclusion criteria were enrolled in the trial. Subsequently samples were sent for culture to confirm that either T. rubrum, T. mentagrophytes, or E. floccosum were the causative organism.|
746338|NCT00835497||
746339|NCT00835484||
746340|NCT00835406||
746341|NCT00835380||114 subjects were enrolled for vaccination screening. Subject eligibility was reviewed according to the inclusion/exclusion criteria, and blood samples were collected for HAV (hepatitis A virus) antibody and ALT (alanine aminotransferase) testing. Finally 80 HAV-susceptible subjects with normal ALT were administered vaccines at the Day 1
746342|NCT00835367||
746343|NCT00835354||
746344|NCT00835341||
746345|NCT00835328|Participants were recruited based on a confirmed clinical diagnosis of congenital hyperinsulinism at 1 academic medical center between August 2009 and October 2019. The first participant was enrolled on August 26, 2008 and the last participant was enrolled in January 25, 2017.|Of the 14 enrolled participants, 13 met inclusion criteria and were randomized to treatment.
746346|NCT00835276||
746347|NCT00835263||
746348|NCT00835237||
746349|NCT00835224|34 subjects were consented 24 completed testing. Subjects were recruited through the Center of Excellence for the Medical Consequences of Spinal Cord Injury (SCI) from June 2010 to August of 2013.|Eligibility criteria were covered by the study coordinator prior to enrollment.
746350|NCT00835211||
746351|NCT00835198||
746352|NCT00835185||Participants with known best overall response and off study treatment were considered to be completed.
746353|NCT00835172||
746354|NCT00835159|Patientsof 65years and older admitted for elective surgery undergeneral anesthesia were screened. Only patients at risk fordeveloping POD were considered for recruitment|This was a randomized, placebo controlled, double-blind clinical trial. Screened patients were 65 years +, having elective surgery under general anesthesia. Only patients at risk for POD were considered for recruitment. Eligible patients received rivastigmine 5cm2 transdermal or placebo patch. 30 patients recruited but only 28 had complete data.
746355|NCT00835146||
746356|NCT00835120||
746357|NCT00835081||
746358|NCT00835068||
746359|NCT00835042||
746360|NCT00835003||
746361|NCT00834990||
746362|NCT00834977||
746363|NCT00834964||
746364|NCT00834912||
746365|NCT00834899|Patients with sickle cell disease, admitted with an acute pain episode, and who met eligibility criteria were approached to participate.|Patient who agreed to participate provided informed consent and were screened for eligibility. Eligible patients were subsequently randomized to treatment with eptifibatide or placebo.
746366|NCT00834886||
746367|NCT00834873||
746368|NCT00834834|Recruitment is from community clinicians, advertising and the emergency department.|All participants are washed out of psychotropic medications. Benzodiazapines are permitted for sleep.
746369|NCT00834808||
746370|NCT00834795||
746371|NCT00834756||
746372|NCT00834743||
746373|NCT00834717||
746374|NCT00834678||
746375|NCT00834652||
746376|NCT00834639||
746377|NCT00834626|Recruitment started in Jan 2008, at Kirloskar Hospital. Recruitment completed in May 2010.|
746378|NCT00834613||
746379|NCT00834587||
746380|NCT00834574||
746381|NCT00834561||
746382|NCT00834535||
746383|NCT00834522||
746384|NCT00834483|This single-blinded, prospective, randomized trial was conducted from February 2009 through June 2009 and was approved by our institutional review board. Recruitment was in our office only.|No participants were excluded except those that would not sign consent. 5 patients were excluded as they did not want to participate giving us 65 offers and 60 enrollments.
746385|NCT00834444||
746386|NCT00834431||
746387|NCT00834418||
746388|NCT00834405||
746389|NCT00834366||
746390|NCT00834340||
746391|NCT00834288||
746392|NCT00834275||
746393|NCT00834249||
746394|NCT00834236||
746395|NCT00834210||
746396|NCT00834197||
746397|NCT00834171||
746398|NCT00834132||
746399|NCT00834106||Participants were stratified by age before randomization: 20 to 26 years of age and 27 to 45 years of age.
746400|NCT00834080|This study had a 12 month recruitment period (May 2009 through April 2010). A total of 11 sites in the United States participated. Principal Investigators were addiction specialists who had contact with health care professionals in need of treatment for opioid dependence.|Potential subjects must have participated in a detoxification program for opioid dependence. Subjects participated in psychosocial treatment throughout their study participation.
746401|NCT00834067||
746402|NCT00834041||
746403|NCT00833989|The study was conducted between 08-July-2009 and 31-January-2011 at 15 centers in 3 countries including 2 centers in Canada, 8 centers in Germany and 5 centers in the United States. Of the 15 centers, 10 centers enrolled participants.|A total of 42 participants were randomized and included in All subject population.
746404|NCT00833976||
746405|NCT00833937||
746406|NCT00833924||
746407|NCT00833911||
746408|NCT00833898|Caregivers and their patients were recruited consecutively between 11/2008 and 4/2012 during pre-transplant screening of all Allo-HSCT patients and their caregivers at a single site (Presbyterian St. Luke's Medical Center, Denver, CO).|149 patient-caregiver dyads were consented (298 participants) and 148 dyads were randomized. 1 dyad (2 participants) did not meet the inclusion criteria.
746409|NCT00833859||
746410|NCT00833833||Phase 2: Participants were stratified by age (≤ 75 vs. > 75), prior number of treatments (2 vs. > 2), and prior thalidomide exposure (yes vs. no).
746414|NCT00833703|49 participants were enrolled between January 2009 and January 2010 in 25 sites in 15 countries (7 countries involved in CLARINET study were not selected as the delay in obtaining IRB/IEC and Health Authorities approvals would prevent recruitment and/or no patient would be recruited as the second surgery is always performed before 1 year of age).|
746415|NCT00833690||
746416|NCT00833664||
746417|NCT00833638||The first phase of the study was a run-in phase that lasted for approximately 4 weeks. During this time, subjects did not use any form of treatment for erectile dysfunction and were instructed to make at least 4 sexual intercourse attempts with their sexual partner. The purpose of this phase was to obtain baseline data for analysis purposes.
746418|NCT00833586||
746419|NCT00833560|401 participants were enrolled at 41 study sites in Germany.|Out of 401 participants, 399 participants were treated in both the Parts. Out of 399 participants, 395 participants were evaluated as 4 participants who had received cyclophophamide dose of greater than 1350 mg/m^2 per cycle in Part 1 were excluded.
746420|NCT00833547||
746421|NCT00833521||
746422|NCT00833482||A total of 185 participants were enrolled in the study, and 153 were not treated, because they no longer met study criteria, withdrew consent, or were alternate participants who were no longer needed. The remaining 32 participants received treatment.
746423|NCT00833469||Seven subjects were enrolled in this study. Prior to receiving treatment, two subjects were found to be ineligible per protocol eligibility requirements.
746424|NCT00833443|Participants were recruited via advertisements and outreach in the Los Angeles area|
746425|NCT00833417|The study population consisted of patients ≥ 18 years old with a histologically confirmed diagnosis of advanced basal cell carcinoma (BCC), either metastatic or locally advanced BCC. Enrollment of patients with locally advanced BCC was limited to 80 of a planned total of 100 patients. Both cohorts received the same vismodegib 150 mg treatment.|
746426|NCT00833365||
746427|NCT00833261||
746428|NCT00833248|The participants were recruited by outpatient urologists, radiotherapists or oncologists. A total of 240 patients were to be randomised in a 3:1 ratio to one of two treatment groups (180 participants were to be treated with degarelix; 60 participants were to be treated with goserelin+bicalutamide). The recruitment period was April 2009 - June 2011.|
746429|NCT00833105||
746430|NCT00833092|Participants were recruited in 2007 and 2008 by the USDA Grand Forks Human Nutrition Research Center staff in North Dakota.|425 applications were received. 215 people did not meet the eligibility criteria. 99 people withdrew their application. 111 people were assigned to groups.
746431|NCT00833053|Multicenter: 48 centers in Australia, Belgium, Colombia, Canada, Denmark, France, Germany, Greece, Hungary, Italy, and Russia.|Of the 39 participants that were randomized to the study, 3 (2 Infliximab [IFX] q 6 weeks; and 1 IFX + Methotrexate [MTX]) participants did not meet protocol eligibility criteria and were excluded from the efficacy analysis.
746432|NCT00833040||42 patients were enrolled and entered the Titration Phase. 36 patients determined an effective dosage of sufentanil and were randomized to the Double-Blind Phase of the study. 2 patients then terminated from the study and did not take any doses after the Titration Phase. 34 patients participated in the Double-Blind Phase of the study.
746433|NCT00833027|"First patient in: 11-MAR-2008
~Last patient out: 30-OCT-2009
~Total number of sites: 110"|
746434|NCT00832975||
746435|NCT00832871||
746436|NCT00832819||
746437|NCT00832780||
746438|NCT00832767||
746439|NCT00832650||
746440|NCT00832637||
746441|NCT00832624|"Recruitment process occurred in the Hospital Regional de Taguatinga between November, 26 2008 and May, 27 2009.
~First Patient in: 26-Nov-2008; Last patient in: 27- May- 2009"|Patients between 18 and 75 years old with type 2 diabetes mellitus (T2DM) and inadequate glycemic control, who had not taken medication for at least 2 months or using a single drug for diabetes mellitus were enrolled in the study. Insulin-dependent patients were excluded from the study.
746442|NCT00832598||
746443|NCT00832585|Subjects were recruited from physician referrals and advertisements placed within the Rush University Medical Center campus. Recruitment was opened between Jan 08 through Sept 09|
746444|NCT00832572|Five participants were enrolled and treated.|
746445|NCT00832520|Enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible. The recruitment period spanned 07Apr2009 through 14Jul2010. All were recruited through the UNM Cancer Center medical clinic.|
746446|NCT00832455|"First patient in: JUN-19-2006
~Last patient out: OCT-28-2008
~Total number of sites: 37 sites in Canada"|
746447|NCT00832416||
746448|NCT00832390|"Single site study with patients recruited in Principal Investigator's private practice, Mexico City.
~First Patient In: 14Feb2007. Last Patient's Last Visit: 11Jul2008"|Treatment naïve patients (30 to 78 years of age) with inadequate glycemic control on diet/exercise were assigned to treatment with sitagliptin alone (A1C 6.5 to <8%), sitagliptin + metformin as initial combination therapy (A1C 8-12%), or standard care.
746449|NCT00832377||44 participants were actually screened. Among them, 7 participants failed in screening (2 participants withdrew and 5 did not meet eligibility criteria). Therefore 37 participants were considered to have enrolled.
746450|NCT00832338|Patients were recruited from April 2009 to October 2015 at Winship Cancer Institute of Emory University, Emory University Hospital Midtown, and Grady Memorial Hospital.|
746451|NCT00832299|Subjects were recruited from the GI Oncology practice.|
746452|NCT00832260||
746453|NCT00832130|A total of 139 subjects (278 eyes) were enrolled at nine clinical sites between 03/04/2009 and 05/14/2009.|At the 2 Week visit, Control subjects stopped the warm compress therapy and received a single Manual Mini (LipiFlow) crossover treatment.
746454|NCT00832117||A total of 30 participants were enrolled; 29 were treated (1 participant no longer met study criteria).
746455|NCT00832091|Recruitment started in 2006 and ended in 2009 using 8 sites: University Medical Center Clinics|Prior to randomization, patients need to meet specific inclusion and exclusion criteria. There was no wash-out or run-in periods
746456|NCT00832078||28 participants enrolled in study. 2 were excluded before randomization as they did not comply with inclusion criteria. One was excluded from study (ITT) as participants dropped out before having any data recorded.
746457|NCT00832000|Eligible participants were at least 16 years of age, had clinical symptoms or signs of NDM, and myotonic potentials on electromyography. Participants were either enrolled in the CINCH NDM Natural History Study, or a new patient with genetically confirmed NDM, or with clinical features of NDM but negative myotonic dystrophy DNA testing.|Patients taking anti-myotonic agents were required to discontinue medications for a wash-out period equal to 7 times the half-life of elimination prior to their baseline visit. Participants were ineligible if they has specific contraindications to taking mexiletine (cardiac conduction defects, hepatic or renal disease, or heart failure).
746458|NCT00831987|The study participants were enrolled from 06 through 16 August 2004 in 1 US site.|A total of 120 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
746459|NCT00831844|No patients were enrolled in Group 10, recurrent or refractory retinoblastoma.|
746460|NCT00831792|Castration-Resistant Prostate Cancer patients were enrolled between 2010-2013|
746461|NCT00831779|Of 116 participants enrolled, 50 completed a qualification period. Of these 50 participants, 44 were randomized and received treatment. Of these 44 participants, 42 completed double-blind treatment period.|
746462|NCT00831766|Participants were enrolled at Moffitt Cancer Center and Cleveland Clinic between June 2009 and March 2014.|
746463|NCT00831753|Participants were enrolled from 23 May 2008 to 18 July 2008 at 1 clinical center in Peru.|A total of 263 participants who met the inclusion and exclusion criteria were randomized and vaccinated in the study.
746464|NCT00831701|Randomisation of 100 pts between 09.2006 and 09.2008 in a University Hospital|10 patients were excluded from the final analysis due to stone expulsion before medication intake or withdrew of consent
746465|NCT00831675|The study participants took part in the study from 16 September through 18 November 2004 in 1 US site.|A total of 30 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
746466|NCT00831493|The recruitment period is May 8, 2009 to October 5, 2010. All participants were recruited at UT MD Anderson Cancer Center.|
746467|NCT00831480|Fifteen subjects signed informed consents. Out of that 15, 9 took at least one dose of study drug.|
746468|NCT00831441||7484 participants enrolled and 7392 were randomized. Reasons for non-randomization: 2 Adverse event (AE), 18 withdrew consent, 1 lost to follow up, 3 administrative reason by sponsor, 2 deaths, 51 no longer met criteria, 15 other.
746469|NCT00831428|The scottish national and district teams were assessed during training weekends.|All members of the squad were offered the opportunity to take part.
746470|NCT00831415|This was a 10-month, open-label, multicenter study of Japanese participants with Major Depressive Disorder (MDD) conducted from March 2009 to March 2011 at 61 sites in Japan.|A total of 304 participants who completed the short-term Core Study (NCT00798707 [3151A1-3359 / B2061003]) consented to enroll in this long-term, open-label, flexible dosing Extension study (NCT00831415 [3151A1-3350 / B2061002]). Baseline in this Extension study = Day 56 of the Core study.
746471|NCT00831389||
746472|NCT00831311|Participants were enrolled and treated from 26 October 2004 to 10 November 2005 in 1 clinical center in Argentina.|A total of 624 participants who met the inclusion but no exclusion criteria were enrolled and vaccinated.
746473|NCT00831272|A sample of participants was recruited through advertisements in local media, referrals from physicians, or self-referrals. Recruitment occurred between January 2009 and September 2013. Participants were recruited from 5 sites.|
746474|NCT00831233|The participants were recruited by outpatient urologists. 280 participants were to be randomised in a 3:1 ratio to one of two treatment groups (210 patients were to be treated with degarelix; 70 patients were to be treated with goserelin plus bicalutamide). The trial was stopped early due to poor recruitment.|
746475|NCT00831181|Subjects were recruited from 2004-2009 from the oncology practice at Beth Israel and Roosevelt Hospitals.|
746476|NCT00831129||
746477|NCT00830960|This study had 4 treatment arms and had 2 cohorts; a Primary Cohort (≥60 kilograms [kg] and age <75 years) and a Low Weight/Elderly cohort (<60 kg or age ≥75 years). Randomization was stratified by country, cohort and anticipated glycoprotein (GP) IIb/IIIa inhibitor use.|"One participant who was enrolled based on weight >60 kg was not assigned to primary cohort due to no weight entered in case report form.
~Low Weight/Elderly Cohort was only assigned to prasugrel 30-mg loading dose (LD)/5-mg maintenance dose (MD) or clopidogrel 300-mg LD/75-mg MD due to evidence of increased bleeding risk for these populations."
746478|NCT00830947||
746479|NCT00830869|Participants took part in the study at 7 investigative sites in the United States and Canada from 02 March 2009 to 20 April 2012.|Participants with diagnosis of nonhematologic malignancies were enrolled in 1 of the 2 parts, Part 1: Dose escalation to determine maximum tolerated dose (MTD), and Part 2: Expansion at MTD in 5 expansion cohorts.
746480|NCT00830804|Study participants were recruited from 22 U.S. sites from April 2009 to August 2009.|Study participants were HIV-1-infected, antiretroviral(ARV)-naive men and women, 18 years and older with plasma HIV-1 RNA >= 5000 copies/ml. One enrolled participant never started study treatment.
746481|NCT00830791||
746482|NCT00830765||
746483|NCT00830596|Participants with acute, subacute, or chronic low back pain were recruited from local communities.|
746484|NCT00830518|Participants took part in the study at 19 investigative sites in France, Canada and the United States from 10 February 2009 to 04 July 2011.|Participants with a diagnosis of acute myelogenous leukemia or myelodysplastic syndrome received 50 mg alisertib twice daily for 7 days in 21 day cycles. Results are reported according to lymphoma disease subtypes: acute myelogenous leukemia and myelodysplastic syndrome.
746485|NCT00830440||
746486|NCT00830388||
746487|NCT00830375|December 2008 - August 2010|
746488|NCT00830362|Individuals who met DSM-IV criteria for current cocaine dependence (within the past month) but who were not dependent on any other substance, with the exception of nicotine, served as participants. The primary method of recruitment was media advertisement (radio, local papers) which ran from January of 2009 until July of 2011.|Exclusion criteria included severe psychiatric comorbidity (e.g., psychotic disorder, bipolar disorder, severe major depressive disorder with suicidal ideation) or medical illness or use of medications that might interact with propranolol. Individuals with other substance dependence (with exception of nicotine) were also excluded at initial visit.
746489|NCT00830336||
746490|NCT00830310|Recruitment began in January of 2009 and the last participant was enrolled in June of 2010.|
746493|NCT00830232|Patients recruitment was started on december 2008 and continued until February 2012. Patients recruitment and consenting were performed at the medical clinic.|Patients were considered officially enrolled after the randomization, which was performed during the procedure after the initial angiography (initial image of the brain blood flow).
746494|NCT00830219||
746495|NCT00830206||
746496|NCT00830167||Participants were administered placebo tablet in single blind manner and evaluated for the inclusion/exclusion criteria during the 1-week screening phase. Participants who demonstrated a high response to placebo, i.e., <=30% decrease on the VAS, were discontinued from the study at the end of the screening phase.
746497|NCT00830128||Participants received the study drug in the precedent study A0081208 (NCT00830167).
746498|NCT00830115||All patients were evaluated, missing values were not imputed.
746499|NCT00830076||
746500|NCT00830037||
746501|NCT00830024||
746502|NCT00829998||
746503|NCT00829985|Four National Institute of Allergy and Infectious Diseases (NIAID) Inner-City Asthma Consortium (ICAC) sites in the United States recruited the targeted number of study participants who fulfilled entry criteria between January and June 2009.|
746504|NCT00829933||
746505|NCT00829868||
746506|NCT00829829|The study was conducted at 49 study sites in Unites States (US) and 15 study sites in Canada between 5 March 2009 and 18 May 2010. A total of 468 participants were screened in the study.|Out of 468 participants, 241 were randomized and 240 treated in the study. Participants were randomized in 1:1:1 ratio to receive either Placebo or Rilonacept 80 mg or Rilonacept 160 mg.
746507|NCT00829790||
746508|NCT00829764||
746509|NCT00829738||All patients were evaluated, missing values were not imputed.
746510|NCT00829712||
746511|NCT00829686|Patients were recruited who presented to the ER with an uncomplicated skin abscess who met inclusion criteria and did not meet exclusion criteria. Informed consent was obtained.|
746512|NCT00829673||
746513|NCT00829621||
746514|NCT00829530||
746515|NCT00829504||
746516|NCT00829452||
746517|NCT00829439||
746518|NCT00829426||
746519|NCT00829413|Study Initiation Date (first subject enrolled): 15 June 2010; Study completion date (last patient completed study related activities): 18 February 2013. The study was conducted at 18 investigational sites; 11 sites throughout the United States (USA), 5 sites in Europe, and 2 sites in Canada.|"A total of 67 patients received SonoVue in the training phase and were included only in safety population. A total of 259 patients received SonoVue in the efficacy phase. The 67 patients, included within the Not Completed category below, are the training patients."
746520|NCT00829387|Recruited June 2010 through March 2013 at VA Connecticut Healthcare System|
746521|NCT00829309||
746522|NCT00829296||
746523|NCT00829283||
746524|NCT00829244|Participants were enrolled at 22 clinical trial centers in 9 European countries and 1 center in Chile. Recruitment period: 29 August 2008 to 21 January 2010.|A total of 244 participants gave informed consent and were screened for study entry. Forty-four (44) of these participants were not randomized due to: screening failure (38), failure to down regulate (3), or other reasons (3). A total of 200 participants were randomized to one of the two treatment arms.
746525|NCT00829179|Subjects were recruited from the Pulmonary clinic and the local community from 10/2002 - 07/2004|The majority of screen failures prior to starting study drug was one of 3 reasons; negative methacholine challenge, IgE, too low, or IgE too high.
746526|NCT00829166||"Participants of Lapatinib + Capecitabine arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant Overall Survival (OS) benefit in favor of trastuzumab emtansine demonstrated in second interim analysis (cut-off date 31 July 2012). The safety analysis of the arm was then reported."
746527|NCT00829049||
746528|NCT00829036||
746529|NCT00829010|The oral poliovirus vaccine could be given at any time during the study (routinely given concurrently with Tritanrix™-HepB/Hib vaccine) but was not considered as study vaccine. Out of the 489 subjects enrolled in the study, 484 subjects were assigned to a study group and received vaccination.|"The study included 3 populations defined based on the human immunodeficiency virus status of the mother and the infant. Infant born from:
~a HIV positive mother and HIV infected at Month 0 = HIV+/+.
~a HIV positive mother and HIV exposed uninfected at screening = HIV+/-.
~a HIV negative mother and HIV unexposed uninfected at Month 0 = HIV-"
746530|NCT00828984|Age 18 and older; Recruitment sites: NorthShore University HealthSystem, University of Chicago, Boston University (no accrual occurred)|History of any size adenoma or colon cancer within the last 6 years;
746531|NCT00828945||A total of 259 participants were enrolled in the study, out of which 2 participants were not evaluated due to screening failure.
746532|NCT00828841|The study was open to enrollment at 118 oncology clinics from November 2008 to May 2011.|Consent was obtained from all subjects. Subjects were stratified by histology (non-squamous vs. squamous), followed by disease stage (IIIb vs. IV). Subjects in the non-squamous stratum were randomized to 1 of 3 treatment arms (Arm A, B, or C); subjects in the squamous stratum were randomized to only 1 of 2 of these treatment arms (Arm A or B).
746533|NCT00828750||This study is an open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for the treatment of participants with idiopathic thrombocytopenic purpura (ITP) who had previously been enrolled in eltrombopag trial TRA108109 (NCT00540423).
746534|NCT00828711|Pregnant women who required to be induced were recruited at 11 sites in the US|
746535|NCT00828672|Eighty-four patients were included. First patient enrolled: 22-Jun-2009. Last patient enrolled: 29-Sep-2013. Participating sites: UZ Leuven, Erasme Hospital Bruxelles, Cliniques Universitaires St-Luc Bruxelles, AZ St. Lucas Brugge, AZ Groeninge Kortrijk, CHU Sart-Tilman Liege, OLVZ Aalst, H. Hart Ziekenhuis Roeselare, Cl. Saint Elisabeth Namur|Target population was represented by patients with locally advanced rectal cancer (tumour beyond mesorectal fascia (T4) or tumour ≤ 2 mm from mesorectal fascia or T3 tumour < 5 cm from anal verge by MRI), histologically confirmed. Pts were screened as per incl and excl criteria per protocol. Screening failures were not recorded in the eCRF.
746536|NCT00828568|Patients were recruited at 20 dermatology clinical practices.|
746537|NCT00828542||
746539|NCT00828464|"Recruitment period: First Subject Enrolled October 2008, Last Subject Enrolled January 2009.
~Type of location: Dermatology Research Center"|"Washout from use of systemic corticosteroid and/or other prohibited medications if used within 4 weeks of the baseline visit.
~Washout from use of topical corticosteroid therapy and/or other prohibited topical medications if used within 2 weeks prior to the baseline visit"
746540|NCT00828451|Subjects admitted to the neonatal intensive care unit at St. Louis Children's Hospital were screened and enrolled from 5/1/2008 to 12/31/2009. Infants born at < 32 weeks and 7 days old or less were eligible for enrollment which occurred in the neonatal intensive care unit or postpartum floor.|After enrollment 11 of 29 enrolled subjects did not complete the study due to removal of the intravenous line required for infusion, significant deterioration in clinical status resulting in unstable condition as identified by the attending physician, parental withdrawal, and death.
746541|NCT00828412||
746542|NCT00828347||
746543|NCT00828321||
746544|NCT00828308|First patient enrolled 2/11/09 and last patient enrolled was 3/30/11|
746545|NCT00828295|"First patient enrolled: 19 August 2008. Last patient completed: 27 December 2008.
~A total of 12 Investigators from two countries (Russia and Ukraine) participated in the study. The study was conducted at 4 sites in Russia and 8 sites in Ukraine."|
746546|NCT00828204|Recruitment occurred in the following stages: Main Study (Initial Subset and Main Subset enrolled), and Extension Study. Initial subset participants were withdrawn when the study was suspended. After a protocol amendment, the Main Subset participants were enrolled. Only those in the Main Subset had the option to participate in the Extension Study.|
746547|NCT00828191||
746548|NCT00828178|106 patients were consented and 87 were randomized. Patients were part of the Hopkins Lupus Cohort seen quarterly.|"Some of patients were excluded before being randomized for several reasons including change of mind by patient, became pregnant, diagnosed with breast ca. Therefore a total of 87 patients started the trial."
746549|NCT00828139||
746550|NCT00828113||
746551|NCT00828074||
746552|NCT00828061|"First Patient Entered: 04-Feb-2009
~Last Patient, Last Visit: 21-May-2009
~2 sites"|
746553|NCT00828009|E6508 was activated on December 22, 2010, suspended per protocol on January 12, 2012 for interim toxicity analysis. The study was then reactivated on October 9, 2012 to stage 2 accrual and closed to accrual on October 13, 2014.|
746554|NCT00827983||
746555|NCT00827944|Study period: 42 months First patient in: 13 October 2008 Last patient in: 27 April 2011 Last Patient visit: 8 May 2012 Follow-up duration: 1 year|
746556|NCT00827931||
746557|NCT00827918|Male and female inpatients who were experiencing an acute exacerbation of schizophrenia were randomized at 21 sites worldwide.|Participants who met entry criteria were washed out of psychotropic medication and then entered a single-blind, in-patient, 3-day to 7-day, placebo lead-in period.
746558|NCT00827827||
746559|NCT00827775||
746560|NCT00827632|Participant-related activities were conducted between July 2006-December 2008 in New York City|Eligible women were aged 18-35 years with a recent history of regular, spontaneous menstrual cycles, and agreed to use an Oral Contraceptive Pill (OCP) for 3 to 4 months and undergo eight biweekly study visits during the third or fourth OCP cycle.
746561|NCT00827606||
746562|NCT00827567|Recruitment period 4/13/2009 through 2/25/2011. Protocol dated 3/6/2009 & consent dated 4/8/2009 for the 4/13/2009 approval.Patients were seen at Penn State Cancer Institute Outpatient Unit.|Two of the patients that were screen failures had cholesterol levels higher than inclusion criteria as this drug may increase cholesterol levels they were not eligible.
746563|NCT00827541||
746564|NCT00827502||
746565|NCT00827372|This study was to enroll 14-15 patients. Due to toxicity and enough patients met the definition of response , this study was halted early, leading to a smaller number of subjects analyzed. There were 10 patients at baseline, 7 patients at Cycle 2, Day 1 and 2 patients who completed the 6 cycles of planned treatment.|
746566|NCT00827255||Retrospective analysis. Patients may have been treated with Restasis® (cyclosporine ophthalmic emulsion 0.05%) in addition to other medications during the course of the study.
746567|NCT00827242||
746568|NCT00827112||
746569|NCT00827099|Study was IRB approved on 6/8/06. The first patient was enrolled on 6/9/06. The last patient was enrolled on 12/22/08.|There were no group assignments for this study. It was a single arm cord blood transplant study.
746570|NCT00827073||
746571|NCT00826943||
746572|NCT00826800|Protocol Open to Accrual: 01/19/2009 Protocol Closed to Accrual: 04/13/2010 Primary Completion Date (if applicable): 12/28/2010 Recruitment Location is the medical clinic|
746573|NCT00826748||24 subjects underwent informed consent and enrolled into the study. 2 smoker subjects screen-failed (recent illicit drug use history of myocardial infarction). These individuals were dropped from the study prior to randomization, therefore only 22 individuals were assigned into one of the three study groups.
746574|NCT00826618||
746575|NCT00826540|83 patients were registered between 06/03/2009 and 10/20/2009 from 25 North Central Cancer Treatment Group (NCCTG) sites.|One patient withdrew from the study and three patients were ineligible, therefore, these patients were excluded from all results.
746576|NCT00826449|Recruitment Period: February 6, 2008 to July 18, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 53 participants registered, only 47 were eligible and treated. The study was terminated early due to futility.
746577|NCT00826280||
746578|NCT00826267|Because of slow enrollment and a high screen-failure rate, recruitment became a challenge and the sponsor chose to terminate the trial prior to reaching the target enrollment of 120 patients.|
746579|NCT00826241||
746580|NCT00826228|Recruitment from outpatient clinic at rehab hospital|
746581|NCT00826202||
746582|NCT00826176||Two subjects were screened but not enrolled (one Chinese subject and one Caucasian subject).
746583|NCT00826150|Clinical sites|
747167|NCT00796003|39 participants were enrolled at multiple sites in Japan.|9 participants were enrolled and treated in Phase 1. 36 participants (including 6 participants from Phase I) were enrolled in Phase II. 34 participants were treated and 2 participants were untreated in Phase II.
746584|NCT00826111|The recruitment period was from September 2008 until October 2010. Participants were recruited by advertising in the community.|Enrolled participants were excluded before assignment to groups if they had another co-morbid psychiatric diagnosis, a medical condition that could affect glutamate or GABA levels, a clinical presentation that was not consistent with a diagnosis of major depressive disorder, or rating scale scores below the minimum for inclusion.
746585|NCT00826020|Patient recruitment began May 1, 2008. The study was closed October 6, 2017|
746586|NCT00826007|Retrospective review of patients who underwent surgical procedures at our institution from 2003-2009|Retrospective
746587|NCT00825994||Of the 31 participants who consented at V1, 7 were ineligible at this visit. The remaining 24 were given a 1-week single-blind placebo lead-in. Women who met criteria for placebo response, defined as a >= 50% decrease in MADRS (Montgomery-Asberg Depression Rating Scale) from screening to end of the run-in phase, were excluded from the study.
746588|NCT00825916|Enrollment in the study began in April 2009 and was completed in August 2009. All patients were enrolled at dermatological medical clinics.|
746589|NCT00825825|Participants were recruited by advertisement from April 2008 until January 2011.|Participants had their serotonin transporter genotyped. Individuals with a genotype of SS or SLg were not randomized. A total of 85 potential participants were screened. Of those, 21 were excluded on the basis of genotype. Another 28 were determined to be ineligible for other reasons and 6 withdrew prior to randomization.
746590|NCT00825812||308 participants were randomized
746591|NCT00825786||
746592|NCT00825734|Patients were recruited at multiple dose levels into the Dose Escalation (Phase I) portion of this study to determine the safest dose of this regimen (MTD-Maximum Tolerated Dose). Upon determination of this dose, patients being treated at the MTD proceeded to the Dose Expansion (Phase II) portion of the study and additional patients were recruited|
746593|NCT00825682|The study included 72 breast cancer patients, scheduled for complementary radiation therapy at the Cancer Center at Tel Hashomer Hospital during the years 2008-2011. Participants were recruited to the experimental and control groups, on a voluntary basis.|Exclusion criteria: breast cancer patients with metastatic lesions on lower limbs, coagulation disorders and patients receiving other contact treatments.
746594|NCT00825630|Two out-patient clinics in hospitals will enroll subjects|Size of arms varied due availability of PPI (proton pump inhibitors) and desire to gather more data in most common PPIs.Ethics committees approved additional recruitment.
746595|NCT00825565|Subjects were identified at regularly scheduled clinic visits with the Principal Investigator at Children's Memorial Hospital.|Subjects were instructed to discontinue use of allantoin 1.5% cream (Alwyn) for at least 30 days prior to initiating the study medication, allantoin 3% cream (Alwextin).
746596|NCT00825500||
746597|NCT00825370||
746598|NCT00825344||
746599|NCT00825318||
746600|NCT00825305|Study participants were enrolled in November 2008 at 1 center in China.|All enrolled subjects were randomized, but one subject in the Zagreb (2-1-1) group was not vaccinated.
746601|NCT00825266||
746602|NCT00825227||
746603|NCT00825175|Recruitment in Winter 2007 for in home intervention.|Subjects were excluded if they previously had worn foot orthoses
746604|NCT00825162||
746605|NCT00824993|This was a prospective, randomized, placebo-controlled trial. Eligible patients were at least 18 years old and had undergone an allo-SCT for hematologic malignancy treatment within 45 days.|We screened 414 patients and 78 were enrolled.
746606|NCT00824850|Participants were previously enrolled in Prevnar protocol D118-P8 (study duration 1995 to 1998) and were randomized to receive either 7-valent pneumococcal conjugate vaccine or meningococcal C conjugate vaccine in that study.|
746607|NCT00824824|A total of 21 primary open angle glaucoma patients were recruited for the study from the practices of Douglas J. Rhee, Angela V. Turalba, and Louis R. Pasquale at Massachusetts Eye and Ear Infirmary, Boston. Recruitment took place between February 13, 2009 and December 21, 2011.|Prior to the initial testing visit, subjects ceased using their current IOP-lowering medications and were run in for 6 weeks on timolol 0.5% BID OU. After this 6 week period baseline measurements were taken and 7 were identified with retinal vascular dysregulation. These 7 patients were then randomized into one of two treatment arms.
746608|NCT00824772|"Dates of recruitment: 2008 Sep - 2010 Feb
~Type of location: university hospital"|No group assignment required for this study.
746609|NCT00824746||
746610|NCT00824733||
746611|NCT00824720||
746612|NCT00824655||Group 1 participants received 1 dose of Prevenar at least 42 days prior to study enrollment. Group 2 participants received 2 doses of Prevenar with the last dose at least 140 days prior to study enrollment.
746613|NCT00824616||
746614|NCT00824564||
746615|NCT00824538|Patients (pts) were enrolled in this study over the course of a year, from May 2009 through May 2010. A total of 21 patients were screened, and 13 patients, demonstrating ≥ 10 DTCs/mL via bone marrow aspiration, were deemed eligible.|13 patients were enrolled, and 11 received 6-month bone marrow aspirations after completing sunitinib treatment.
746616|NCT00824512|Patients were recruited at a single centre investigational site in France.|Overall number of baseline participants differs from number of participants who started as efficacy analysis was performed on modified Intention-To-Treat (mITT) population (i.e. 21 patients). 1 patient in the placebo group did not meet the primary criteria and thus excluded from the analysis. No patient was excluded from the safety population.
746617|NCT00824473|First observation: 30 Dec 2008 Last observation: 13 Feb 2009|Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
746618|NCT00824460||
746619|NCT00824434|Enrollment of 100 subjects was planned, 100 were enrolled at 14 investigative sites in the Asia Pacific region by July 22, 2009.|
746620|NCT00824421||
746621|NCT00824408||
746704|NCT00819741|The trial was conducted at 17 sites in China.|Between screening and treatment with trial drug, subjects were assessed for eligibility and were randomised to one of two treatment arms. After start of treatment, all the subjects underwent a 6-week dose titration period followed by a 10-week maintenance period. A subgroup of 50 subjects from each treatment group was chosen.
746622|NCT00824382|The first patient was enrolled in the trial on 13 January 2009 and the last patient made the last visit on 31 March 2010. A total of 515 patients were enrolled in the trial at 48 trial sites. Of the 515 patients, 328 patients were entered in the trial and were randomly assigned to receive either one of the four treatments for 4 weeks.|Informed consent was obtained prior to patient participation in the trial, which included medication washout procedures or restrictions. Upon obtaining consent, the patients were instructed on the medication washout and other restrictions for the screening PFT (Visit 1).
746623|NCT00824369|Participants from two parent studies (A5271015 and A5271022) were included if they discontinued treatment due to virologic failure or other reasons. Participants from 6 countries were enrolled into the A5271015 study and the A5271022 study enrolled participants from 8 countries.|Twelve and 40 participants who had received: LRV 500 mg QD, LRV 750 mg QD or efavirenz 600 mg QD (in A5271015);or LRV 750 mg QD, LRV 1000 mg QD or etravirine 200 mg BID (in A5271022) were enrolled and treated with open-label antiretrovirals excluding LRV. Data summaries were provided by the randomized treatment groups of the parent protocol.
746624|NCT00824291|A total of 752 potential participants were screened for this study. 437 participants were randomized to treatment groups while 315 participants were not randomized (288: did not meet the study criteria; 27 were not randomized for other reasons). Of the 437 randomized participants, 10 participants did not receive the study treatment.|
746625|NCT00824265|Participants (par) were screened within 14 days prior to the start of study drug administration to determine eligibility.|Eligible par were stratified by Stage (Binet A vs. B vs. C) and number of prior therapies (1-2 vs. ≥3). Par in each stratum were then centrally randomized in a 1:1 ratio to recive intravenous (IV) fludarabine and cyclophosphamide in combination with ofatumumab or IV fludarabine and cyclophosphamide alone.
746626|NCT00824161|Patients with chemotherapy-refractory advanced colorectal cancer have been recruited at 3 study sites in US between January 2009 and November 2009.|No screening period.
746627|NCT00824070|This study was conducted a 6 sites in the US. This was a single dose study with first patient enrollment on 2/2/2009 and last patient visit was 7/9/2009.|105 subjects were screened at Visit 1 and qualified subjects returned on the day of surgery (Visit 2).
746628|NCT00824044|The first patient was screened on January 6, 2009, and the last patient was screened on October 26, 2010. The study was completed at the Depression Clinical and Research Program at Massachusetts General Hospital.|
746629|NCT00824005|Enrollment took place at five Network centers and their associated satellite facilities between April 29, 2009 and April 18, 2011. The main centers are located in Ohio, Texas, Florida, Minnesota, and Tennessee. Study brochures, patient informational DVDs, and clinical trials.gov were among the tools used for recruitment.|
746630|NCT00823979||
746631|NCT00823966|08 December 2003 to 31 March 2009, a total of two centers in Japan|
746632|NCT00823901|Subjects were recruited at MGH and Stanford University Hospital.|Some subjects required a wash-out of medications they were using. Subjects were excluded if they did not have enough lesions.
746633|NCT00823836||A total of 157 participants who were enrolled in the Non-Inferiority Verification (NV) Phase entered into the Long-term Phase after completing the Prolonged Release/Extended Release (PR/XR) Switching Phase according to the study design. The remaining participants entered into the Down-titration Phase after completing the PR/XR Switching Phase.
746634|NCT00823823||
746635|NCT00823797||
746636|NCT00823719||
746637|NCT00823615||Two participants were enrolled but not dispensed due to failing inclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
746638|NCT00823472|Patients were recuited between 11-9-2008 and 1-10-2010 in both centers.|Patients who didn't completed the trial were cancelled before OPU due to low- or hyperresponse or before ET due to total fertilisation failure or no embryo to transfer.
746639|NCT00823459||
746640|NCT00823303||
746641|NCT00823264||
746642|NCT00823212|Enrollment of 1,532 patients was planned; 1,530 patients (762 PROMUS and 768 PROMUS Element) were enrolled and randomized at 132 clinical sites from January 27, 2009 to September 4, 2009. Of these, 788 patients were from the USA, 562 from Europe, 124 from Japan, and 56 from the Asia-Pacific region excluding Japan.|
746643|NCT00823199|Ten subjects were recruited, in-patients in a State Hospital, between 2005 and 2008|
746644|NCT00823134||
746645|NCT00823095||
746646|NCT00823082||
746647|NCT00823069||
746648|NCT00823043||
746649|NCT00822926||
746650|NCT00822900|A total of 882 patients underwent randomization at 49 trauma centers in the United States between April 5, 2010, and October 30, 2013. 442 patients were randomized to Progesterone Arm and 440 were randomized to Placebo Arm.|
746651|NCT00822770|Recruitment Period: January 2, 2009 to February 1, 2012. All recruitment done at the University of Texas MD Anderson Cancer Center.|
746652|NCT00822757||
746653|NCT00822692|Patients were enrolled at 3 hospital emergency departments from July 1, 2008 to June 1, 2009.|Patients were assigned by block randomization and data was analyzed with intention to treat analysis.
746654|NCT00822679|Potential participants screen failed. There was no subject randomized (n=0).|
746655|NCT00822588||
746656|NCT00822523||
746657|NCT00822510||
746658|NCT00822354||
746659|NCT00822328|24 healthy volunteers were recuited on Jan.11, 2009 at Cheng Hsin Rehabilitation Medical Center.|
746660|NCT00822237||
746661|NCT00822185|This trial was conducted at a single site in Japan.|
746662|NCT00822172|The first participant was randomized on September 19th, 2008 and the last subject was randomized on May 7, 2010. Clinical study sites were a mixture of university/hospital settings, Veteran Affairs hospitals, professional research centers and medical clinics.|The study included a cilostazol run in period. From the 164 participants who remained eligible at the end of the run in period, only 1 participant did not subsequently receive treatment. This was due to voluntary withdrawal by the participant.
746663|NCT00822120||
746664|NCT00822107||
746665|NCT00822094||
746666|NCT00821964||
746667|NCT00821951|Patients at Yale New Haven Hospital were recruited for a dose escalation trial between 2009 and 2010. Eligibility criteria included a histologic diagnosis of NSCLC, and an indication for palliative thoracic radiation in patients with either metastatic disease or locally advanced disease that precluded potentially curative therapy.|ECOG PS of 0 to 2, and adequate hematologic, hepatic, and renal function were required. Patients with prolonged QT syndrome or significant cardiovascular disease were excluded, as were patients with untreated brain metastases. Prior thoracic radiation was permitted as long as a treatment field could be designed without significant overlap
746668|NCT00821886||
746669|NCT00821873|All participants were recruited from the patient population at the four investigative sites|This was a single arm study, thus there is no assignment
746670|NCT00821821||
746671|NCT00821795||
746672|NCT00821678||
746673|NCT00821626|Participants were recruited between January 2009 and November 2012.|
746674|NCT00821587|The study was conducted at the University of Florida in Gainesville between July 2004 and April 2008. Patients attended clinic visits at the time of randomization (baseline) and at 12-week intervals for 72 weeks.|Subjects with Hepatitis C Virus (HCV) recurrence Ishak Stage2 were enrolled and randomized to stay on Tacrolimus (TAC) or to change to Cyclosporine (CsA) for baseline immunosuppression with 1-month washout period before initiation of therapy with Pegylated Interferon Alfa2a and ribavirin for 48 weeks for genotype-1, or 24 weeks for genotype-3.
746675|NCT00821509|Occupational health clinics of 6 corporations in the Helsinki region contacted in 2008; 21 study clusters identified with at least. 50 employees in common office work in each; Active recruitment by personal invitation to all members of the identified clusters (N=1270)in early January 2009 by emails including a designated risk interview (see below)|Based on the cumulated acute infection risk (day-care of children, age, smoking, chronic CV- or lung disease, frequent business travel etc.)in each cluster the clusters were ranked according to the calculated risk index, and out of the 7 cluster triplets with most similar index, one was randomly allocated to each of the three study arms
746676|NCT00821431||
746677|NCT00821327||
746678|NCT00821236||
746679|NCT00821184||
746680|NCT00821119|The started study date of recruitment was March 2008 in a single center. One of the biggest hospital in the northeast of brazil with an inborn tertiary NICU|Infants were excluded for any of the following reasons: major congenital anomalies, presence of cardiovascular instability, intubation at admission to the NICU, consent not provided or refused and unavailability of a ventilator. there were 423 eligible infants and 223 excluded, 200 participated in the study
746681|NCT00821093||Out of total 1123 randomized patients, two patients withdrew from study prior to exposure to study drug.
746682|NCT00821041||
746683|NCT00821015|Subjects presenting with AF for ablation recruited from the clinical practice of the Investigators.|
746684|NCT00820898|This trial was opened to patient entry on February 2, 2009 and was closed to accrual on July 27, 2009.|
746685|NCT00820872||
746686|NCT00820755|First/last participants (informed consent): January 2009/17 March 2010. Clinical data cut-off: 17 December 2011|Enrolled: 673 screened for eligibility; 90 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 583 participants started.
746687|NCT00820664|Patients were recruited through advertisement and review of patient databases at Comprehensive Phase I, USA, between December 2008 and April 2009.|Major entry criteria - healthy postmenopausal women within 10 years of attaining menopause as determined by follicle-stimulating hormone (FSH) and estradiol levels within range of postmenopause, and other criteria. Normal transvaginal ultrasound at screening with endometrial thickening at < 5.0 mm.
746688|NCT00820612|Between February 2009 and July 2011, 602 subjects were enrolled at 4 university-affiliated medical centers in the United States.|Of the 799 consented subjects, 169 were not randomized because an inclusion criterion was not met, 11 were not randomized because an exclusion criterion was met, and 17 were not randomized because ERCP not performed.
746689|NCT00820599|One patient withdrew prior to procedure. Prior to procedure, two patients were noted as having significant co-morbidities not accounted for by the Euroscore, therefore they were exited from the trial prior to procedure.|Three enrolled subjects did not enter the procedure room.
746690|NCT00820573|Texas Diabetes Institute from March 2010 July 2011|A 4 week washout period for those subjects on oral anti-diabetic therapy with sulfonylureas was used in 7 subjects
746691|NCT00820534|Study start : 30 dec 2008 Study end : 16 Nov 2009 Hospital out patient clinic|Cold Sore confirmed by local temperature measurement
746692|NCT00820443||
746693|NCT00820248||
746694|NCT00820235||
746695|NCT00820222||
746696|NCT00820170||
746697|NCT00820040|"Subjects diagnosed with infected prosthetic mesh who were scheduled to undergo planned removal of the mesh were assessed for potential study eligibility.
~Subjects needed to fulfill all inclusion criteria and no exclusion criteria to be enrolled into the study."|One subject was considered a screen failure due to undergoing chemotherapy for an active malignancy within a year prior to the screening visit.
746698|NCT00820027||
746699|NCT00819910||
746700|NCT00819832|Recruitment Period: December 30, 2008 to March 29, 2010. All recruitment done at UT MD Anderson Cancer Center.|Study terminated by sponsor. No patient data analysis performed due to the limited amount of data gathered from the study's three participants.
746701|NCT00819793|Protocol included an enrollment allowance of 30 subjects at 25 centers for subjects who fail to wean from cardiopulmonary bypass. 2 additional patients were enrolled to increase the number of LVAD use in the study. Subject enrollment commenced in October 2008. A total of 18 sites participated in the study.|
746702|NCT00819780|First patient was enrolled on 24 April 2009; last patient was enrolled on 09 December 2011.|
746703|NCT00819767|All patients underwent a 2-week washout and a 1-2 week single blind placebo run in. Eligible patients then performed the treadmill exercise test for randomization according to the Bruce Protocol. Patients capable of reaching the defined peak exercise (85% of their predicted HR) were randomized into the study.|
746705|NCT00819637|Study was open for enrollment from 1/8/09 until 11/19/09. Location was Henry Ford Hospital Emergency Department|Only 2 patients were enrolled in this trial
746706|NCT00819585||A total of 432 participants were enrolled in the study.
746707|NCT00819507||
746709|NCT00819390|"Version 1.0 of the study enrolled off antiretroviral therapy (ART) participants only. Off-ART participants were enrolled from March 2009 to July 2010.
~On-ART participants were allowed to enroll in Version 2.0 of the study. On-ART participants were enrolled from December 2010 to November 2012."|Analysis of data from off-ART and on-ART participants was done separately. The study analyses did not utilize the cross-over design, and the primary analysis consists of comparison between the chloroquine and placebo arms after the first 12 weeks on study in each off-ART and on-ART study populations.
746710|NCT00819286|Prospective, randomized trial at 5 US sites and 1 European site. Patient enrollment occurred between November 2008 and May 2010.|Patients were randomized at the time of sternal closure to either rigid plate fixation or wire cerclage. A total of 140 patients were enrolled in this study (70 in each treatment group) and included in an intent to treat analysis.
746711|NCT00819260|Recruitment ran from January 2008 to January 2010. All patients were recruited in one surgical clinic at Dartmouth Hitchcock Medical Center.|Forty-three women were identified as potential study participants from May to December 2009. Three were excluded, because two were unable to consent and one was under 18 years old. Nine women declined to participate. Of the remaining 31 patients (72.1% of those identified), all completed the informed consent, the surgery, and the follow-up process.
746712|NCT00819247||One hundred and fifty-nine participants were screened. One hundred and twenty-nine participants were randomised, two of these participants withdrew before receiving any treatment.
746713|NCT00819234|Participants (overweight and obese) must have been randomized and treated in original DFA102 Study (NCT00673387) in order to be enrolled into this extension study DFA102E and followed for a total of up to 52 weeks, inclusive of DFA102 (ie, DFA102 and DFA102E studies together have a total length of 52 weeks).|DFA102 participants assigned to: placebo, 360mcg pramlintide+1.25mg metreleptin, 360mcg pram+2.5mg metre, or 360mcg pram+5.0mg metre did not change treatment in extension (stable groups). All other groups transitioned to 360mcg pram + 1.25, 2.5 or 5.0mg metre. 274 enrolled in extension and 273 were treated.
746714|NCT00819182|Recruitment occurred from April 1, 2009 to February 1, 2011. Participants were recruited by mass mailings to community-dwelling women and registry participants. Additionally, recruitment occurred in breast cancer and high-risk clinics in the Midwest.|
746715|NCT00819156||Two hundred and sixteen patients were screened. Twenty-seven were screening failures. Two randomized patients were not treated: one withdrew consent and the other had an elevated alanine aminotransferase value (an exclusion criteria found after randomization).
746716|NCT00819091||
746717|NCT00819052||Two patients were randomized, but have not been treated. They were excluded from the treated set.
746718|NCT00819039|This trial was conducted at 18 trial centers: 2 in Brazil, 1 in Finland, 1 in Russia, 1 in Mexico, 4 in Spain, 6 in Turkey, and 3 in the United States.|
746719|NCT00819013|Participants were enrolled from 11 to 27 July 2007 at 3 clinical centers in the US.|A total of 87 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
746720|NCT00818961|The first patient on this study was enrolled & transplanted on 6/9/05. The last patient on this study was enrolled & transplanted on 1/5/11.|"No groups were assigned. Pts received chemotherapy based on their disease. 39 patients consented to study but 36 patients received protocol treatment. 3 patients were considered screen failures and did not move forward on study."
746721|NCT00818883|Participants enrolled at 66 investigative sites in the Russian Federation and the United States from 20 January 2009 to 30 November 2009.|Participants with patients with moderate to severe essential hypertension were enrolled in one of 2, once-daily (QD) treatment groups.
746722|NCT00818805|The recruitment period: May 21-31, 2008 Location: Samoncho Clinic|The study was conducted using an Ohio chamber in two parts: 1) a proof-of concept pilot study designed to assess the appropriateness of the OHIO chamber to induce ocular symptoms. 2) a randomized, single-masked, placebo-controlled, cross-over study.
746723|NCT00818779||
746724|NCT00818766|Patients presenting for elective lung surgery and expected to require tube thoracostomy were approached for participation in the study at the time of preoperative evaluation.|
746725|NCT00818753||
746726|NCT00818662|Recruitment was conducted in the U.S., and Canada, at 45 study sites. The first participant was enrolled in December 2008.|702 participants were enrolled; 308 were screen failures; 4 were discontinued before randomization; and 7 were withdrawn after randomization, but prior to receiving investigational product. Therefore 383 participants were randomized.
746727|NCT00818649|Study entry is open to patients regardless of gender or ethnic background.|
746728|NCT00818623||
746729|NCT00818519|Analyzed: 179 participants randomized, 173 in the FAS (Full Analysis Set): 87 in YAZ, 86 in placebo groups, 143 in the PPS (Per Protocol Set): 74 in YAZ, 69 in placebo groups|193 participants screened, 14 failed screening: withdrawal of consent (7), inclusion/exclusion criteria not met (6), participant lost/no further information available (1). study drug intake was unknown (3) and 3 participants to whom study drug was never administered (withdrawal of consent or lost to follow-up) were excluded from FAS.
746730|NCT00818454|"Crossover Part of the Study (Treatment Period 1)
~Crossover Part of the Study (Washout Period of 1 Week)
~Crossover Part of the Study (Treatment Period 2)
~Parallel Part of the Study Following Second Randomization (Treatment Period 3)"|
746731|NCT00818441||
746732|NCT00818389|Between January 2009 to June 2009, 97 patients were screened and 84 subjects were randomized at 21 clinical sites; 11 in the United States and 10 in Canada. All sites were members of the Northeast ALS Consortium (NEALS) and/or the Canadian ALS Consortium (CALS).|All patients were required to be on a stable dose of riluzole for at least 30 days prior to screening. 13 subjects failed screening: 3 due to low lung function test results, 3 due to prohibited medications,3 due to study closure, 2 due to abnormal lab test results and 1 due to death unrelated to the study.
746733|NCT00818337||
746734|NCT00818324||
746735|NCT00818272||
746736|NCT00818259||Of the 92 unique participants who were enrolled and randomized in Parts I (n=23), II (n=39), III (n=19), IV (n=5) and V (n=6), 91 took part in this study. One participant randomized in Part IIB was discontinued prior to treatment.
746737|NCT00818246||
746738|NCT00818207||
746739|NCT00818168|Participants were those with Ankylosing spondylitis (AS) starting treatment with Remicade at 26 sites in Germany from Jul 2003 through Dec 2010|
746742|NCT00817843|Between and patients were screened of which subjects were randomized in the following centers UMC Utrecht, Utrecht, the Netherlands AMC, Amsterdam, the Netherlands Vascular Research Center, Hoorn, the Netherlands Tweesteden Ziekenhuis, Waalwijk, the Netherlands Hospital Arnau de Vilanova, Lleida, Spain|Prior to randomization subjects were given a 2 week placebo controled run-in phase to test for adequate compliance.
746743|NCT00817804|Hospitalized adult patients enrolled between Jan 17 and Mar 3, 2009.|Excluded if did not meet inclusion or did meet exclusion criteria.
746744|NCT00817778||
746745|NCT00817596||
746746|NCT00817531|The study started recruitment in December 2010. Baylor college of Medicine is the only site of the study.|each patient have to be eligible and pass all screening tests after signing the consent to be enrolled in the study.
746747|NCT00817479|Patients were enrolled between July 2003 and September 2007 through the Gynecologic Oncology Clinic at the University of Chicago subject to the inclusion and exclusion criteria described in the registration record.|
746748|NCT00817336||
746749|NCT00817219|The study period was 15 July 2009 (date of first subject's first screening visit) to 05 December 2011 (date of the last subject's last on-treatment visit)|Before starting treatment there was a washout/screening phase lasting for 3 days to 6 weeks, depending on the prior use of excluded treatments.
746750|NCT00817206||
746751|NCT00817089||
746752|NCT00817063|A total of 599 participants were randomized, out of these 3 participants did not receive study medication, hence Intent-to-treat (ITT) population consisted of 596 participants which included all randomized participants who were dispensed medication.|A total of 942 participants entered the run-in period for a maximum of 16 weeks who received class 1 corticosteroids for 2 weeks followed by corticosteroids of any potency. Out of 942 participants, 343 participants were run-in failures and hence 599 were randomized in the study.
746753|NCT00816907|A randomized, double-blind, placebo-controlled multicenter trial conducted between March 2009 and February 2010 at 17 academic, veterans affairs, and private research clinics. 146 clinically stable overweight outpatients with chronic schizophrenia and schizoaffective disorder were enrolled.|Prior to randomization prospective participants were screened for eligibility
746754|NCT00816829|Subjects were recruited and treated in a hospital in Paris between September 2005 and January 2008|In total 34 subjects were randomly allocated to treatment (i.e. Subjects Started). All the subjects received the study drug and completed the study. The study was prematurely terminated because of low recruitment.
746755|NCT00816777||
746756|NCT00816751||
746757|NCT00816595||
746758|NCT00816556||
746759|NCT00816400|Participants were recruited at 5 centers in the United States between March 2009 and January 2012.|A total of 49 participants were screened, out of these, 35 participants were randomized.
746760|NCT00816361|A total of 43 participants ((23 participants in dose-escalation phase and 20 participants in dose-expansion phase) were entered in the study and received the study treatment.|
746761|NCT00816348||
746762|NCT00816166|Subjects were screened and enrolled at 27 sites worldwide (23 sites in the US and 4 sites outside of the US).|125 consented,of which 112 were randomized.Of 112,110 were treated (64 Stent Arm & 46 Med Therapy [MT] Arm).Of 112, 111 met criteria & in analysis pop (58 Stent Arm & 53 MT Arm).During course of the study,of 59 randomized to Stent Arm,4 treated w/MT Only & 1 failed to meet eligibility & excluded, & of 53 randomized to MT Arm, 9 treated w/Stent+MT.
746763|NCT00816101|Recruitment dates: June 2008-August 2008 Location: Dermatology Clinic|
746764|NCT00816062||166 subjects were enrolled in the previous cohort study (NCT # is not available). 94 subjects were enrolled into the Vitality study. When these two cohorts are combined it totals 260. The Vitality study collected information on its 94 enrolled subjects, but for study analysis both cohorts were combined.
746765|NCT00816036||
746766|NCT00816023||
746767|NCT00815997||
746768|NCT00815919||
746769|NCT00815776||Subjects completed a screening visit and were provided a diary record their Temporomandibular Disorder severity. Subjects returned to the clinic, were randomized if they qualified, and were assigned a treatment group. 150 subjects were planned, but the site over-enrolled 2 subjects due to a temporary problem with the database subject count.
746770|NCT00815698||
746771|NCT00815685|Eligible participants will include cancer patients with Men and Women >25 years of age (inclusive), with a confirmed diagnosis of cancer, unintentional weight loss of >5% of body weight, using uniform established diagnostic criteria and be admitted to the study within 3 month of diagnosis.|
746772|NCT00815659||
746773|NCT00815633||
746774|NCT00815516|Infants greater than 48 hours of life through day of life (DOL) 120 with a diagnosis of invasive candidiasis were eligible for this study.|In total, 31 infants were screened and 30 were randomized in a 2:1 ratio to receive micafungin or amphotericin B deoxycholate. Randomization was stratified by estimated gestational age (< 27 weeks, ≥ 27 weeks) and by region (North America/Europe, Latin America / Mexico, other region).
746775|NCT00815490|Recruitment 10/2007 - 12/2008 at Duke University Medical Center.|Healthy volunteers recruited with specific exclusion of anemia & hemoglobinopathy.
746776|NCT00815360|We included 30 treatment-naïve eyes of 22 patients (8 bilateral patients) aged ≥ 18 years of age, with Type 1 or 2 diabetes mellitus and visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on Ultra Widefield Fluorescein Angiography (UWFA).|Treatment naive patients
746777|NCT00815347||
746778|NCT00815308||
746779|NCT00815295|Patients with recurrent and/or metastatic squamous cell carinoma of the head and neck were enrolled between January 2008 and March 2011. The study was closed prematurely due to poor accrual.|Three patients were consented to the research study but withdrew consent prior to starting treatment. These patients are not included in the data presented.
746780|NCT00815191||
746856|NCT00811473|This multicenter study was conducted between 27 January 2009 and 1 November 2010, which included the recall visit. The recall visit occurred from 5 June 2010 till 1 November 2010.|The study had an up to 35-day enrollment period, 8-week double-blind treatment period with 1 of 2 treatment regimens (quetiapine XR 150 to 300 mg/day or placebo), 1-week safety follow-up period, 2- to 4-week safety follow-up period for patients with BP >95th percentile at completion/discontinuation.
746781|NCT00815087|Twenty subjects were referral from department of oncology & physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan. The study was approved by the Ethics Committee of the National Taiwan University Hospital. All participants gave their informed consent.|They were assigned into the FES group and home rehabilitation program (HRP) group by the method of sex stratified randomization, and were matched by Dysphagia Outcome and Severity Scale (DOSS) score within 1 unit in order to compare two groups under the same sex proportion and similar DOSS score pairs.
746782|NCT00815035||
746783|NCT00814983||
746784|NCT00814970|Recruitment was for a period of 20 months. Subjects were recruited at medical clinics who participate in clinical trials.|
746785|NCT00814892|Two (2) participants were recruited between Jan 2009 and March 2010 at Mayo Clinic. This trial was permanently closed in March 2010 due to funding issues. Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|
746786|NCT00814879|A total of 60 patients were randomized in this pilot study; 30 in each arm. Two patients randomized to stay on their N(t)NRTIs+PIr regimen were randomization failures as the patients did not for return for their baseline visit.|
746787|NCT00814801||
746788|NCT00814788||
746789|NCT00814775||
746790|NCT00814710||
746791|NCT00814697|All patients were recruited from a tertiary memory disorders practice. Patients were diagnosed as having probable or possible Alzheimer's Disease (AD), using the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.|Exclusion criteria included newly diagnosed AD, pacemaker placement, a history of implanted metal object, seizures or epilepsy, a recent history of migraines, uncontrolled depression and those on medications lowering the seizure threshold.
746792|NCT00814671|192 individuals assessed for eligibility, 39 excluded, 153 randomized.|
746793|NCT00814658||22 patients were enrolled in the study, but one (1) patient was excluded from the study because the patient has died before study medication use. Therefore, the study was formed by 21 patients that used at least 1 study medication dose and had at least 1 evaluation after started use (Intention to Treat (ITT) population).
746794|NCT00814632||
746795|NCT00814580|The recruitment period for this outpatient, multicenter US only study occurred between Jan. 14, 2009 and Mar. 19, 2010|The study consisted of a screening period (up to 21 days) and a double-blind active treatment period (7 days, but can be up to 9 days).
746796|NCT00814502|Subjects were recruited from among the patients admitted to the Massachusetts General Psychiatric inpatient service, Blake 11. Inclusion criteria included age between 60-99 years and a clinical diagnosis of Alzheimer's dementia and/or vascular dementia using DSM-IV criteria.|3 subjects signed informed consent (IC) but were never randomized, and are not included in the table below. One changed his mind prior to randomization; another had untreated sleep apnea, discovered the day after he signed IC; the IC of a third subject was not received from her health care proxy until after her discharge from the hospital.
746797|NCT00814489||
746798|NCT00814463|Patients were recruited from the Duke Comprehensive Cancer Center from 6/12/2008 - 6/5/2009.|
746799|NCT00814346||"A total of 63 participants were screened of which 49 subjects were randomised to either EGb761 and Placebo treatment groups (double-blind period).
~The 49 randomised subjects consisted of three groups of elderly subjects: Cognitively normal elderly (CNE), Memory Complaint (MC) and Alzheimer's Disease (AD)."
746800|NCT00814333||
746801|NCT00814320|Recruitment was conducted 14 clinical sites in the United States and 1 clinical site in Canada.|89 participants who enrolled were screened. Of these, 2 withdrew before treatment (both were screen failures)
746802|NCT00814307||
746803|NCT00814255||"32 patients consented however 8 were not assigned to treatment because they failed to meet eligibility at the end of the screening
~1 patient was assigned to rosiglitazone and was not included in the analysis."
746804|NCT00814177|160 patients were randomized at a single center during the period July 2006 - August 2008|The study was planned for the sample size of 326 but due to competing studies, testing new dosing algorithms, the inclusion rate was much lower than expected.
746805|NCT00814164||
746806|NCT00814138||
746807|NCT00813995||
746808|NCT00813982||One participant was enrolled but not dispensed due to failing inclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
746809|NCT00813943|First/last participant (informed consent): Mar 2009/Sep 2011. Clinical data cut-off: 07 Feb 2013, Study completion date: Aug 2013.|Enrolled: 294 screened for eligibility; 29 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria), 265 participants randomized.
746810|NCT00813917|Recruitment began on 4/13/09 and completed on 08/16/10. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, MN and Franciscan Skemp Medical Center in Lacrosse, WI) for consenting and additional study procedures to determine eligibility.|
746811|NCT00813904||Of 31 participants enrolled, all received treatment with recombinant thrombin (rThrombin).
746812|NCT00813865||Participants were screened for evaluation of eligibility to participate in the study. Eight participants received at least 1 dose of study drug.
746813|NCT00813813||
746814|NCT00813800|11 patients were enrolled from the community all with bipolar depression and the desire to stop smoking.|36 patients who were screened did not meet inclusion/exclusion criteria and excluded from participation.
746815|NCT00813761|Subjects were recruited in both the US and UK and were screened, randomized, and assigned to a study arm.|A total of 473 subjects were attempted to be enrolled. There were 27 disqualified, 2 due to incorrect care system, 1 due to non-compliance, and 24 due to non-compliance from investigator, leaving 446 subjects recruited to participate.Of those remaining, 21 failed to meet inclusion or were excluded for a total of 425 subjects who started the study.
746816|NCT00813748||
746857|NCT00811434|Informed consent was obtained on the first subject 1/16/2009 and recruitment continued until study closure in November 2010.|Two subjects were withdrawn prior to randomization.Two did not meet entry criteria.
747168|NCT00795951|Single Site- Rady Children's Hospital Recruiting Period-09 December 2008 (first subject enrolled) 27 October 2009 (last subject exited)|No significant events or approaches
746817|NCT00813709|Participants who were randomized in Study 27025 (NCT00404352) were eligible to enroll into extension Study 28981 (NCT00813709) whether or not they completed main study on Investigational Medicinal Product (IMP), or no treatment or received other disease-modifying drugs (DMDs) during course of main study. No re-randomization was done for this study.|517 participants randomized in Study 27025 used in this study as integrated intention to treat (ITT) population. Out of the 517, 402 participants took part in study 28981: 300 comprised the double blind (DB) population and 122 comprised the open label (OL) population (some participants (20) were included in both populations)
746818|NCT00813592||
746819|NCT00813488|Subjects with chronic pain who had been receiving opioid therapy for the previous 7 days and reported on average 1 to 5 breakthrough pain episodes per day were recruited from 50 different study sites throughout the United States beginning December 2008 and completing in November 2009.|"Prior to the double-blind treatment period, subjects participated in two titration periods to identify a successful and tolerated dose of FBT and immediate-release oxycodone. Subjects who did not titrate to a successful and tolerated dose were excluded from further participation in the study."
746820|NCT00813319||
746821|NCT00813293|Participants enrolled from June 2009 through August 2013.|
746822|NCT00813176||
746823|NCT00813150|The study was conducted between 23 December 2008 and 10 January 2013 and recruited patients from 42 study centers in Germany.|A total of 93 participants were randomly allocated and they received at least 1 dose of study drug and were included in the safety analysis. Of these follow-up data on treatment response was not available for 3 participants, so, they were excluded from the Intent-to-treat (ITT) analysis data set and so, ITT included 90 participants.
746824|NCT00813111||
746825|NCT00813098|This was a multi-center trial in the United States, with 36 investigators participating.|There was a 14-day Run-in period before randomization.
746826|NCT00812981||
746827|NCT00812968||
746828|NCT00812955|474 subjects were randomized and treated at 111 sites in the United States between 29 December 2008 and 14 May 2009.|
746829|NCT00812929|This was a Phase IIa multi-center study conducted in the United States from 02 December 2008 to 15 July 2009.|A total of 47 participants were randomized in the study who underwent a screening visit of 28 days prior to first dose of study medication.
746830|NCT00812916||
746831|NCT00812877|Thirty-five dental practices recruited and enrolled subjects between May 2009 and March 2011.|Randomization was done on a practice level rather than a patient level. The handling characteristics of the two materials were so dissimilar that it was not feasible to blind the practitioners as to which material they were using.
746832|NCT00812838||
746833|NCT00812812||This study consisted of 3 phases: a 2-week placebo run-in phase, an 8-week treatment phase, and a 0- to 3-week taper phase. In the run-in phase, placebo was administered once daily for 2 weeks. In the treatment phase, paroxetine or placebo was orally administered once daily for 8 weeks. In the taper phase, the dose was gradually reduced.
746834|NCT00812708|Most patients were recruited from the principal investigator's ophthalmic practice. A few were referred by local ophthalmologists.|
746835|NCT00812604||
746836|NCT00812565|The first patient was enrolled February 2, 2009. The last patient study visit was September 21, 2010. Patients were enrolled in this study from a variety of settings including private practice clinics and hospitals. There were 12 study sites, 5 in Germany and 7 in the United States.|Qualified patients meeting all inclusion exclusion criteria and providing informed consent were enrolled into the trial.
746837|NCT00812487|Hospitalized patients with type 2 diabetes and heart failure exacerbation were recruited between 2008-2013 from an academic medical center.|Patients were randomized to intravenous or subcutaneous insulin. There were no pre-assignment changes in therapy before randomization. One patient was excluded after consent but prior to randomization due to receipt of corticosteroids which is an exclusion criterion.
746838|NCT00812461||
746839|NCT00812331|A total of 37 participants from 3 countries were enrolled and started treatment in the study (17 participants in Belgium, 12 participants in Germany, and 8 participants in Thailand).|A total of 48 participants were screened of which 11 participants were not treated with TMC435. A total of 37 participants received study medication.
746840|NCT00812253||
746841|NCT00812110|During the 2008-2009 influenza season, 474 caregivers were approached. 292 agreed to participate,and had not received influenza vaccine.|
746842|NCT00812097||
746843|NCT00812006|"First Patient In: 26 March 2009; Last Patient Last Visit: 22 October 2009.
~17 Outpatient centers worldwide (10 United States; 2 Canada; 2 Spain, 2 Italy; 1 France)"|"Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible,
~were randomized at the same visit."
746844|NCT00811954|Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between May 22, 2009 (date first subject was randomized) and June 9, 2011 (date last subject was randomized).|1814 were randomized 1:1:1 to treatment arms A, B, and C. Results reported for 1809 eligible participants; 5 were subsequently found ineligible and excluded from all analyses.
746845|NCT00811941||
746846|NCT00811928||
746847|NCT00811850||
746848|NCT00811798||
746849|NCT00811733||
746850|NCT00811720||
746851|NCT00811655|The subjects were consented and interviewed in a private room in the Duke clinics. The patients came to Duke Radiology Center, found to be eligible and then provided options by the neuro-radiologist. They were consented by the research nurse at one of these visits.|The only reason that enrolled participants were excluded from the trial prior to treatment assignment was if there were development of any exclusion criteria.
746852|NCT00811642||
746853|NCT00811590||
746854|NCT00811577|Enrollment in the study began in January 2009 and was completed in December 2009. All patients were enrolled in dermatological medical clinics.|
746855|NCT00811564||
746927|NCT00808249|International multi-center study, 44 sites recruited between Dec 2008 and May 2009|Screening for eligibility and wash-out of restriced medications. 725 subjects enrolled but 424 subjects were randomized. Number of participants analyzed is the number of subjects in MITT (modified intent to treat) population, it is different with any of population listed in the participant flow chart.
747227|NCT00792935||
746858|NCT00811395|"107 and 110 participants who successfully completed 24-week visit in, respectively, PDY6045 and PDY6046 studies, were offered to continue their treatment in this extension study.
~After signature of the informed consent and confirmation of selection criteria, 86 and 96 participants entered the extension study."|"An Interactive Voice Response System was used to allocate kits containing the same treatment as in the initial study.
~Analysis included all participants randomized in the initial studies and all data collected from randomization according to intent-to-treat principal."
746859|NCT00811382||
746860|NCT00811317||
746861|NCT00811252|Patients were mainly recruited via psychiatric, psycho-geriatric, and geriatric inpatient or outpatient settings.|The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind down-taper period (Week 9); and a 4-week Safety Follow-up Period after completion/withdrawal (Weeks 8 to 12).
746862|NCT00811187|This was a investigator-sponsored single site clinical trial. Patients were recruited based on physician referral at Montefiore Medical Center from March 2007 to June 2008. Patients were excluded from participation if they had a known allergy to lidocaine.|Of the 80 patients that met inclusion and exclusion criteria, only 74 completed either the lidocaine or saline placebo single-injection. Patients were randomized 1:1.
746863|NCT00811174|Patients previously treated with commercial Octagam 5% were to be enrolled in the study on the basis of the in- and exclusion criteria defined in the study protocol. Patients were to be enrolled only after written informed consent by the patient had been obtained.|
746864|NCT00811135||Screening details were taken 28 days prior to baseline. There were 88 participants included from 23 centers.
746865|NCT00811070||
746866|NCT00811057|All participants were hospitalized in labor and delivery at University of Mississippi Medical Center in active preterm labor.|
746867|NCT00811018|Participants were enrolled from studies FPH02/FPH02-X (STRIDE 2/STRIDE 2 Extension [NCT00080457, NCT00593905]), FPH04 (STRIDE 4), FPH06 (STRIDE 6) or were naive to sitaxsentan sodium.|
746868|NCT00810901||
746869|NCT00810888||
746870|NCT00810810|"Patients scheduled for cardiac surgery at the U. Washington or an affiliated program at Northwest Hospital had the study explained to them by the clinical team including a clinical research coordinator and consent was obtained.
~Recruitment began in August of 2006 and extended until August of 2010."|There were 7 individuals who consented but were not randomized: late discovery of exclusionary criteria, surgery cancelled, individual withdrew.
746871|NCT00810797||
746872|NCT00810771|The Usual Care group is not counted toward the Enrollment total. See description of group below for additional details.|The Usual Care group is not counted toward the Enrollment total. See description of group below for additional details.
746873|NCT00810719|Patients were enrolled at University of California Davis and the University of Southern California.|
746874|NCT00810693|Only participants with symptomatic Pulmonary arterial hypertension (PAH) could participate in this study. Both treatment-naïve participants and participants pre-treated with an endothelin receptor antagonist or a non-intravenous prostacyclin analogue could be included.|586 participants were enrolled in 124 study centers in 30 countries worldwide. 141 of the 586 enrolled participants were not randomized (adverse event [4], protocol violation [129], withdrawal by subject [8]). 445 of the 586 participants were randomized. 443 of the 445 randomized participants received study medication.
746875|NCT00810641|Between February 2009 and October 2009, consecutive patients with a diagnosis of apogeotropic HC-BPPV were recruited from nationwide 10 Dizziness Clinics in Korea.|We defined the transition as a conversion into another canal type of BPPV without intervening periods of remission. In contrast, recurrence was defined as a redevelopment of any type of BPPV after a confirmed resolution of the positioning nystagmus and vertigo.
746876|NCT00810615|Recruitment occurred from Nov 2008 - Nov 2010. Candidate subjects with a diagnosis of chronic truamatic brain injury (TBI) were identified by DoD neurologists. Those interested were screened for inclusion/exclusion criteria. 103 candidates were screened. 22 did not qualify; 31 were deferred (psychotropic medication or mental status unstable).|
746877|NCT00810602|From March 2008 through February 2013, eligible patients with advanced hematological cancers were enrolled at the University of Michigan and Washington University in St. Louis.|All patients received a preparative regimen of intravenous fludarabine (40 mg/m2 on day -5 through day -2) and busulfan (3.2 mg/kg on days -5 and -4) (FluBu2) followed by the infusion of peripheral blood stem cells (PBSC) on day 0. GVHD prophylaxis consisted of tacrolimus initiated on day -3 and mycophenolate mofetil (MMF) on day 0 through day 28.
746878|NCT00810576|Recruitment Period: 02/17/09 through 04/26/10. All participants recruited at UT MD Anderson Cancer Center.|Trial terminated due to slow accrual, only 1 patient registered.
746879|NCT00810511||
746880|NCT00810446||
746881|NCT00810407||A total 628 subjects were registered in this study. Of the 628 subjects, 594 subjects CRFs were collected and included in the study. Of the 594 subjects, 6 subjects were excluded from the safety analysis set (SAS). In total, 588 subjects were included in the SAS as the completed the study
746882|NCT00810394||
746883|NCT00810368||
746884|NCT00810355|12 subjects consented, but failed to complete intake procedures for randomization. This is why the final results total enrollment number differs from the protocol enrollment number.|
746885|NCT00810342||
746886|NCT00810303||
746887|NCT00810277||
746888|NCT00810264||
746889|NCT00810199||
746890|NCT00810108|Subjects were recruited between August 2008 to August 2009 from the Special Immunology Program at Children' National Medical Center in Washington DC.|
746891|NCT00810095||
746892|NCT00810082|Patients were recruited from two sites, each a physical therapy clinic in a hospital setting.|
746893|NCT00810069|Participants showing improvement (≥30% baseline score reduction on the HAMD-17) during Period I did not continue to Period II of the study. Qualified participants for Period II were randomized to either Early Intervention Strategy Arm or Delayed Intervention Strategy Arm.|Baseline demographics and primary and secondary outcomes are reported only for Period II (Double Blind Treatment Strategy). Adverse events (AEs) are reported for Period I (Acute Escitalopram Treatment) and Period II.
746894|NCT00810043||
749759|NCT00671606|Recruitment period: 4/28/2008 to 5/4/2010. All participants were recruited at UT MD Anderson Cancer Center.|
746895|NCT00809965|This study, an efficacy and safety study of rivaroxaban in patients with acute coronary syndrome, was conducted between 26 November 2008 and 19 September 2011. Patients were recruited from 766 study centers located in 44 countries worldwide.|A total of 15,526 patients were randomly allocated to the 3 treatment arms in the study. A total of 15,350 patients (5,115 patients in the rivaroxaban 2.5 mg bid group, 5,110 patients in the rivaroxaban 5 mg bid group and 5,125 patients in the placebo group) who received at least 1 dose of study drug were included in the safety analysis set.
746896|NCT00809926||
746897|NCT00809848||
746898|NCT00809835||
746899|NCT00809809|Subjects were recruited at 3 medical clinics: Women's Health Services, Santa Fe, NM; Continuum Center, NYC, NY; SCNM medical Clinic, Scottsdale, Az|Subjects were excluded if they had HSL for more than one day
746900|NCT00809757||
746901|NCT00809614|A total of 42 patients were planned and recruited. The patients were randomized to either AIN457 2x10 mg/kg or placebo in a ratio of 2:1. The total sample size of 42 included an additional 3 subjects to allow for drop-outs and/or incomplete data.|
746902|NCT00809523||
746903|NCT00809471|Subject recruitment occurred at US investigative sites between December 2008 and February 2010.|Subjects meeting the initial eligibility criteria completed a 4-week non-treatment run-in period during which information on each attempt at intercourse was recorded. At the end of the run-in, subjects meeting the randomization criteria were eligible for assignment to one of the treatment groups.
746904|NCT00809458|Patients were recruited at oncology clinics between December 2008 and April 2010. The study was terminated due to low accrual rate.|One subject suffered an unrelated bone fracture prior to study start, and another was determined to have metastatic disease. 71 participants were screened. 31 did not meet criteria; 25 refused study entry. 15 were enrolled
746905|NCT00809445|Adults receiving drug abuse treatment in drug treatment clinics were recruited, screened for eligibility, and randomized from Jan - May 2009 into 1 of 3 arms: 1) on-site HIV rapid testing with counseling; 2) on-site HIV rapid testing with information only; and 3) referral for off-site HIV testing. Participants were then followed at 1 and 6 months.|2473 patients were assessed for eligibility. Of these, 1313 were eligible and 1281 were randomized; 32 screened eligible, but were not randomized due to: failure to return to the study (n=30), lying about HIV status (n=1) and completing the baseline after the enrollment period closed (n=1).
746906|NCT00809341||1 participant was deemed ineligible and therefore not assigned to intervention. One participant withdrew informed consent prior to starting the study.
746907|NCT00809328||
746908|NCT00809276||
746909|NCT00809185|Patients were recruited from Cleveland Clinic medical hospital from April 2006-March 2009|
746910|NCT00809159|Part 1 of the study, patients received 2 infusions spaced three weeks apart of 10 mg/kg AIN457 or placebo, and in Part 2 of the study, patients received 2 infusions spaced three weeks apart of 0.1 mg/kg, 1.0 mg/kg or 10 mg/kg AIN457, respectively.|Part 1 participants were randomized 4:1 to receive AIN457A or placebo. Part 2, the randomization ratio was to be 2:2:1 for the three dose groups, 0.1 mg/kg, 1 mg/kg and 10 mg/kg. More subjects were randomized to the 0.1 and 1mg/kg dose groups as compared to the 10 mg/kg group, as 24 subjects were already randomized to the 10 mg/kg group in Part 1.
746911|NCT00809146|Subjects treated for status epilepticus in the prehospital setting by paramedics were enrolled at the scene between June 2009 and January 2011. A total of 1023 subject enrollments represented 893 unique subjects with a reenrollment rate of 13%. RAMPART involved 4314 paramedics, 33 EMS agencies, and 79 receiving hospitals across the United States.|Number of patients enrolled includes any repeat enrollments for those who presented to emergency medical services (EMS) with status epilepticus more than once. The number assigned to treatment in the intention-to-treat analysis includes every patient who was enrolled in the study but only the initial enrollment for those enrolled more than once.
746912|NCT00809133|This was a phase I open label trial of continuous dosing with BIBW 2992 (Afatinib) combined with Paclitaxel and BIBW 2992 combined with Paclitaxel and Bevacizumab, BIBW 2992 combined with Carboplatin and BIBW 2992 combined with Paclitaxel and Carboplatin in patients with advanced solid tumours.|This was a dose-escalation trial, using a 3+3 rule based design. Patients were eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
746913|NCT00809094|Recruitment began 11/4/2008. Recruitment process was staggered: Stanford cohort first to focus on safety data related to potential pulmonary hypertension. After half of the Stanford cohort reached the 8-week time point, the DSMC evaluated PH safety data. The other sites then began enrollment. Final subject enrolled on 2/2011.|
746914|NCT00809055||
746915|NCT00808899|Four patients were recruited from December, 2008 through April, 2009. The study was suspended July, 2009 because of the publication of a new standard of care in treatment for patients with high-risk neuroblastoma.|
746916|NCT00808834||
746917|NCT00808808|Potential employers estimated to have at least 60 employees were contacted to determine their interest in participating in the study and were offered an influenza vaccine clinic on site at no cost. A screening questionnaire to determine eligibility was completed. Sites were excluded according to the study inclusion and exclusion criteria.|
746918|NCT00808769|The study period of this study was November 25 to December 21, 2008|
746919|NCT00808665||68 participants were assessed for eligibility but 5 failed Inclusion and Exclusion criteria and were not randomized
746920|NCT00808639||
746921|NCT00808509|Patients with rheumatoid arthritis (RA) treated with adalimumab plus methotrexate and in remission for at least the past 3 months were enrolled from 8 investigative sites in Sweden.|Participants were randomized to continue or discontinue adalimumab treatment for 52 weeks. After the final visit an observational extension period ensued where patients were treated at the discretion of the investigator. The observational extension period lasted until a follow-up visit scheduled at Weeks 104 - 156 (average Week 125).
746922|NCT00808483|Participants were recruited at the hospital the day before surgery from October 2008 to March 2010.|
746923|NCT00808470||
746924|NCT00808444||
746925|NCT00808405|Between January and December 2009, women from Johannesburg, South Africa and Lusaka, Zambia who had previously participated in the HPTN 039 (NCT00076232) study, as well as other women in the community who presented to the research clinics with genetic ulcer disease (GUD) during the recruitment period, were invited to participate in the study.|
746926|NCT00808340||
746928|NCT00808236|Patients were recruited by emergency medical system advanced life support personnel over an 8-month period (November 2008 through June 2009). Patients appearing to meet the study criteria were randomized during ongoing resuscitation procedures. Patients that survived to hospital admission were followed until death or hospital discharge.|"Due to the emergency nature of the research, patients were often randomized into the study before all exclusion criteria could be ruled out (e.g., Do Not Attempt to Resuscitate (DNAR) orders, drug over-dose (OD), cerebrovascular accident (CVA)). Therefore, patients meeting pre-defined exclusion criteria were not included in the outcome measures."
746929|NCT00808210||
746930|NCT00808132||This main study also included 3 sub-studies only for the purpose of the assessment of relevant parameters: breast density sub-study, osteoporosis sub-study (OSS), and sleep sub-study. A participant could participate in more than 1 sub-study.
746931|NCT00808080||
746932|NCT00808067||A total of 5897 subjects were enrolled (rolled over from RE-LY trial), and 5891 were entered in this study. There were 8 subjects not treated; therefore 5883 subjects comprise the 'started' treatment group.
746933|NCT00808028||
746934|NCT00808015||A total of 1429 participants were screened for this study and 1377 participants were assigned to the study treatment.
746935|NCT00807989||
746936|NCT00807937|International multi-center study, 43 sites recruited between Dec 2008 and May 2009|Screening for eligibility and wash-out of restriced medications
746937|NCT00807885||
746938|NCT00807846|This was a phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial in participants with juvenile idiopathic arthritis (JIA). A total of 221 participants were screened into the study in 32 investigator sites.|A total of 101 participants were randomized to treatment with Celecoxib and 100 participants to treatment with Naproxen. Of these randomized, 100 participants received treatment with Celecoxib and 98 participants received treatment with Naproxen. Three participants were randomized but did not receive any treatment.
746939|NCT00807768|GOG 0249 accrued 601 patients from March 2009 to February 2013.|
746940|NCT00807742||
746941|NCT00807664|Patients could be in-patients, out-patients attending hospital clinics specialising in phlebo-angiology, dermatology or vascular surgery, or patients being treated in a non-hospital setting|
746942|NCT00807599||
746943|NCT00807586||
746944|NCT00807573||
746945|NCT00807560||
746946|NCT00807495|Participants took part in the study at 12 investigative sites in the United States from 10 February 2009 to last participant off study 13 February 2013, with a data cut-off on 04 January 2011 to report the primary endpoint.|Participants with a diagnosis of Aggressive Non-Hodgkin's Lymphoma received 50 mg alisertib twice daily for 7 days in 21 day cycles. Results are categorized as disease sub-types: Diffuse Large B-cell lymphoma (DLBL), Mantle Cell lymphoma (MCL), Transformed Follicular lymphoma (TFL), Burkitts lymphoma (BL) and Aggressive T-Cell lymphoma (ATL).
746947|NCT00807456||
746948|NCT00807365||
746949|NCT00807248|The patients were recruited from specialist inpatient and outpatient clinics.|
746950|NCT00807235|Neonates were enrolled between January and August, 2005. This was an open-label study with 2 treatment groups (Regimen 1 and Regimen 2). Eligible neonates were sequentially enrolled and stratified by GA into 2 strata for each regimen. For each regimen, enrollment in Stratum 1 (30 to 32 GA) was completed before enrollment in Stratum 2 (28 to 29 GA).|
746951|NCT00807209||
746952|NCT00807092|A total of 10 sites across China|All eligible subjects had their baseline blood glucose profiles monitored by continuous glucose monitoring system (CGMS) for 72 hours. Following CGMS uninstall and discontinuation of all previous oral anti-diabetic drug (OAD) treatment, subjects were randomised to one of two treatment groups.
746953|NCT00807040||
746954|NCT00807014||
746955|NCT00807001||
746956|NCT00806988||
746957|NCT00806819||5 patients at one investigator site were excluded from the enrollment count because of site non-compliance.
746958|NCT00806676||
746959|NCT00806624||
746960|NCT00806598|Recruitment Period 5/12/2005 - 6/20/2012; all participants were registered at The University of Texas M.D. Anderson Cancer Center.|A total of 53 participants were enrolled on the study, with four patients choosing alternative treatment; one participant died before administration of study treatment.
746961|NCT00806585||Study terminated after participants completed a minimum of 24 weeks of the study (i.e., Phase A) due to lack of efficacy. Phase B was not conducted.
746962|NCT00806546|The study was initiated March 2009 and completed in May 2011. Patients were enrolled from 34 investigative sites across the United States.|
746963|NCT00806494||
746964|NCT00806442||43 subjects were enrolled and signed consent; however, only 39 were randomized into a treatment group. 3 subjects screen failed and 1 subject was lost to follow up prior to randomization.
746965|NCT00806416|Participants were recruited from the following clinical research organizations: Thomas Jefferson University, Division of Clinical Pharmacology, Philadelphia, PA; Clinical Pharmacology Associates, Miami, FL; and Northwest Kinetics, Tacoma, WA, between May 2003 and July 2003.|A total of 244 participants were enrolled in the study (214 participants were enrolled in Part I and 30 participants were enrolled in Part II).
746966|NCT00806403|From Nov. 2001 to May 2003. Cardiology Departments|
746967|NCT00806390||
746968|NCT00806351||
746969|NCT00806286|A total of 108 participants who met all inclusion and no exclusion criteria were randomized to CS-7017 or placebo combined with carboplatin/paclitaxel in the Phase 2 portion study. Three participants were enrolled in the Safety portion and received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).|
746970|NCT00806260|Subject recruitment occurred within the US between January 2009 and March 2009|Period 1 was not a crossover design. Subjects were randomized to either alcohol or alcohol-placebo. Subjects who completed Period 1 were then randomized to the crossover portion of the study, Periods 2 and 3.
746971|NCT00806234||
746972|NCT00806221||
746973|NCT00806195||All subjects enrolled were included in the trial.
749760|NCT00671554||
746974|NCT00806078||Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) either as intact capsules or capsules opened and their contents mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Following a 7 day wash out period, all participants were given the alternate dose under similar conditions.
746975|NCT00806026||
746976|NCT00805961||
746977|NCT00805948||
746978|NCT00805935|The original plan was for 200 participants to be enrolled across six (6) women's reproductive study centers across the US.|127 patients were screened. 120 patients were randomized. Of the randomized patients, 10 did not receive treatment. 110 randomized participants started the study on treatment.
746979|NCT00805870||
746980|NCT00805792|Enrollment extended from November 2008 through April 2010. The study was conducted at the Mayo Clinic sites in Jacksonville, FL and Rochester, MN.|
746981|NCT00805766||
746982|NCT00805740||
746983|NCT00805675|83 participants signed informed consent. 36 patients were not recruited. 32 patients failed inclusion/exclusion criteria and 4 withdrew consent. 47 participants were eligible and recruited.|Out of a total enrollment of 47 participants, 1 participant withdrew consent before being randomized into treatment.
746984|NCT00805545|Recruitment was from November 1, 2008 through November 30, 2009 on the Labor and Delivery unit at the University of Florida.|We used computer generated random numbers to assign patients to the two groups. Patients were excluded from the study if they were allergic to either of the study drugs or if they had evidence of infection prior to surgery.
746985|NCT00805532||
746986|NCT00805493||
746987|NCT00805480|The planned enrollment was for 100 participants. However, one center was prematurely terminated and the data from this center could not be used for analysis. Therefore, additional participants were randomized to replace the 30 participants from the early terminated center. As a result, a total of 130 participants were enrolled.|
746988|NCT00805467|A total of 624 patients were enrolled: 1, 59, 183 & 381 were allocated to the 50mg twice daily (bid), 100 mg once daily (qd), 150 mg qd and 100 mg bid groups, respectively. As this was a long-term extension study no specific end date was given. Patients who were ongoing when the study was terminated are shown as completers.|Treatments were assigned according to those given in the qualifying studies. All patients received investigational product.
746989|NCT00805441||
746990|NCT00805389|Approximately 75 subjects in each group, approximately 23 and 52 subjects/group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I and II subtypes [Subset 1 and 2, respectively], received a booster dose of HBsAg at Day 360.|Study duration was of 390 days for subjects in Subsets 1 and 2 (subjects identified with a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) vaccinated with an additional dose of Hepatitis B surface antigens (HBsAg)) and of 360 days for subjects not receiving this dose of HBsAg.
746991|NCT00805285||
746992|NCT00805207||
746993|NCT00805194||
746994|NCT00805142||95 participants signed the informed consent form, of which 78 participants were enrolled in the study.
746995|NCT00805038||
746996|NCT00805025|Participants were enrolled at a total of 21 study sites in the United States. The first participant was screened on 08 December 2008. The last participant observation was on 14 October 2009.|131 participants were screened and 89 were enrolled and treated.
746997|NCT00804999||
746998|NCT00804986||
746999|NCT00804973||
747000|NCT00804908||A total of 346 subjects were randomized; 2 subjects did not receive study drug and were excluded from the safety analysis.
747001|NCT00804843||
747002|NCT00804713||39 participants were enrolled but lost to follow-up before skin testing or blood draw were performed. This was due to the administrative requirements of the basic training setting, not because of the study itself.
747003|NCT00804687||
747004|NCT00804648||
747005|NCT00804609|30 patients enrolled at Stanford clinics|The patients were divided into 2 groups: group E (epidural) consisted of patients undergoing elective cesarean delivery or undergoing nonelective cesarean delivery during labor. Group SE (Spinal-Epidural) consisted of patients undergoing an elective cesarean delivery. Patients received an anesthetic consisting of a combined spinal-epidural.
747006|NCT00804596||5 subjects signed informed consents but did not meet inclusion/exclusion criteria so were not considered enrolled in the study.
747007|NCT00804570||
747008|NCT00804349|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
747009|NCT00804193||
747010|NCT00804141||A total of 1040 participants who met the inclusion/exclusion criteria were assigned to receive treatment and 1034 of these participants received at least 1 dose of study drug.
747011|NCT00803959|Between November 2008 and June 2010, a total of 630 women underwent randomization (315 in each group) at 11 participating US sites. Of the 53 participating surgeons, 38 were urogynecologists and 15 were urologists; more than 90% were fellowship-trained.|4083 women with urinary incontinence were screened for eligibility; of these 2708 did not meet inclusion criteria, 379 declined to participate and 313 were eligible but excluded for administrative reasons. This left 683 who provided written informed consent; 40 were deemed ineligible before randomization and 13 withdrew consent with 630 randomized.
747012|NCT00803790||This was a randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). A washout of at least 12 days separated each treatment period within each part of the study. 318 participants were enrolled (251 in Part 1 and 67 in Part 2).
747013|NCT00803777|Subjects actually recruited ranged in age from 5 to 24 years old. Subjects under age 18 were accompanied by a parent or guardian.|
747014|NCT00803751|The patients were recruited from pediatric day surgery.|There were 11 patients excluded from the trial due to incomplete data.
747015|NCT00803738|Patients were recruited at 31 dermatology clinical practices.|
749761|NCT00671528||Due to lack of recruitment, the study was terminated early. Only 3 participants of the anticipated 207 participants were enrolled.
747016|NCT00803712|First participant was enrolled on 19 February 2009 and last participant completed the study on 5 July 2011. 313 participants were enrolled from 82 study centers in US, Europe, Canada, Australia and Russia.|Once participants were determined to be eligible for the study, they entered a pre-randomization wash-out phase of 4 weeks (if receiving vitamin D at the time of enrollment). Four enrolled participants did not complete the pre-randomization wash-out phase and were not randomized into the study.
747017|NCT00803686||
747018|NCT00803647||
747019|NCT00803634|Participants with symptoms of acute heart failure (AHF) and elevated blood pressure (BP) presented to the Emergency Departments at 13 hospitals (9 US; 3 France; 1 Germany) between Feb 2009 and Feb 2012 and received either clevidipine or standard of care (SOC) continuous IV antihypertensive therapy for management of their blood pressure.|Eligible patients who met all inclusion and none of the exclusion criteria, including confirmation that systolic blood pressure (SBP) was ≥160 mm Hg immediately prior to study drug, were randomized into the study. If SBP < 160 mm Hg immediately prior to drug, the patient was not to receive study drug and was treated per institutional practice.
747020|NCT00803595|This multicenter, double-blind,randomized, active-controlled trial was conducted from November 2008 through March 2009 at 117 institutions in Japan, Taiwan, Korea, and China (Hong Kong).|Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data. The data for the baseline characteristics is provided for this analysis set, not for all participants who entered the trial.
747021|NCT00803569||
747022|NCT00803543||
747023|NCT00803517||
747024|NCT00803452||
747025|NCT00803413|Between August 2002 and March 2004, 351 women that attended 4 community centers located in the city of São Paulo, Brazil, responding to invitations by folders and voice announcements, filled a form with basic questions about physical activity and low back pain (LBP). After a clinical evaluation, 119 patients fulfilled the study criteria.|
747026|NCT00803400|180 patients were preselected for the study and 150 were eligible for the study. They were outpatients from the office practice and were recruited from March 2005 to July 2007.|30 selected patients were not included: 12 did not match the 20 points for the Hamilton Anxiety Scale; 10 had history of medical diseases (5 of hypothyroidism, 4 of hypertension, and 1 of chronic fatigue syndrome); 8 had other associated psychiatric diseases: (5 had major depressive disorder and 3 had social anxiety disorder).
747027|NCT00803361||
747028|NCT00803283||
747029|NCT00803270|40 women were screened, 29 met eligibility criteria and 27 were enrolled between November, 2008 and March, 2009. The trial was terminated in March 2009 due to inadequate enrollment.|All enrolled participants were randomized.
747030|NCT00803244|First Patient First Visit 28 JAN 2009, Last Patient Last Visit 31 AUG 2009|
747031|NCT00803205|A total of 299 male and female participants with nonsense-mutation-mediated cystic fibrosis (nmCF) aged ≥6 years signed the informed consent form and were screened for eligibility, of which 61 did not meet entry criteria to participate in the study.|A total of 238 participants were randomized in a 1:1 ratio to either ataluren or placebo. Six participants (4 in the ataluren arm; 2 in the placebo arm) were excluded from the Intent-to-Treat (ITT) population because they did not have at least 1 post-Baseline forced expiratory volume (FEV1) assessment by Week 8.
747032|NCT00803179||
747033|NCT00803114|Parturients were recruited at Mount Sinai Hospital labor and delivery unit. Recruitment took place between March 2002 and November 2004.|Parturients were approached prior to delivery if they had received epidural analgesia for labor. Following a vaginal delivery, the subject was randomized to one of the two arms.
747034|NCT00803101||
747035|NCT00803062|The study was activated on 4/6/2009 and closed to accrual on 1/3/2012.|
747036|NCT00803049|The study was conducted at 117 centres in 21 countries between 16 October 2006 and 23 December 2015. A total of 742 participants who completed study EFC6049 (NCT00134563), entered in this extension study (LTS6050 [NCT00803049]).|Participants who received placebo in EFC6049 study were randomized in 1:1 ratio to receive either teriflunomide 7 mg/day or 14 mg/day and, those who received teriflunomide 7 mg/day or 14 mg/day in EFC6049 (NCT00134563) received same double-blind treatment in this extension study.
747037|NCT00803023||
747038|NCT00803010|Patients recruited between 09/10/2008 through 05/13/2011 from the Blood and Marrow Transplant Program patient population.|
747039|NCT00802997||
747040|NCT00802945||
747041|NCT00802919||Overall, 93 subjects were consented, 2 withdrew consent before randomization, and 87 provided evaluable data on at least one outcome measure. The number enrolled 93, is less than the number started 91, because 2 patients withdrew consent before randomization
747042|NCT00802893||
747043|NCT00802880|The study opened to accrual on 03/16/2009 and closed to accrual on 12/15/2014.|
747044|NCT00802867|Participants were enrolled from 05 February through 30 November 2004 at 19 US sites.|A total of 989 participants were enrolled and vaccinated with DAPTACEL as the fifth dose after receiving 4 doses of Pentacel vaccine in previous studies.
747045|NCT00802854||
747046|NCT00802841|Participants were randomized in 1:1 ratio to imatinib 600 mg QD or nilotinib 400 mg BID for a 2 year study period.|Cross-over from one arm to the other was allowed for intolerant patients anytime during treatment, patients who failed to achieve CCyR after 6 months of treatment, loss of response, loss of CHR, loss of best achieved cytogenetic response any time during treatment, or other reason approved by the Study Management Committee.
747047|NCT00802737|Per study protocol|Completed study Hx-CD20-406 (Study OMB111773; NCT00349349)
747048|NCT00802685|Recruitment was initiated on 01/02/08; the final patient was recruited on 7/26/10. Patients were enrolled at Jackson Memorial Hospital. Study was terminated early due to lack of availability of IV ibuprofen due to manufacturer's recall.|"179 subjects had consents obtained. Of these, 6 consents were withdrawn and 68 enrolled subjects were not randomized because they met exclusion criterion before randomization: hemodynamically significant PDA (n=10), absence of PDA (n=55) and other reasons (n=3).
~Therefore 105 enrolled subjects were randomized into 1 of 2 treatment arms."
747049|NCT00802672||
747050|NCT00802659||
747051|NCT00802633||
747052|NCT00802529||
747053|NCT00802503||
747054|NCT00802464||
747055|NCT00802438|The recruitment period lasted two years (July 2008 through November 2010. Participants were recruited from our Recruitment Database, through local advertisements and the local allergy/asthma clinics.|After a participant signs a consent form, he/she goes through an extensive screening process that includes 4 research visits to the clinic before being assigned to their treatment. The inclusion/exclusion criteria for this study was long and many subjects screen failed prior to being assigned to a treatment.
747056|NCT00802412||
747057|NCT00802360|One hundred ninety one (191) participants were screened from 6 study centers in the US; 173 of these participants were eligible for randomization. Six subjects did not receive their respected treatment and two subjects withdrew consent, 165 subjects were included in the statistical analyses|
747058|NCT00802204|"9 lean enroll but only 8 complete. The lean complete study after baseline outcome measurements.
~19 obese enroll but only 18 complete baseline outcome measurements and of these 15 completed the VLCD and post-outcome measurements"|
747059|NCT00802178||
747060|NCT00802113||Out of the 30 enrolled subjects, only 23 subjects received both MAC and AutoSCT and Reduced Intensity Conditioning (RIC) and allogeneic hematopoietic cell transplantation (AlloHCT). 7 subjects did not complete the transplantation and therefore were not included into data analysis.
747061|NCT00802100|This feasibility-focused pilot study was conducted at 14 clinical sites affiliated with the Schizophrenia Trials Network in 2008-9.|
747062|NCT00802074||
747063|NCT00801983||
747064|NCT00801931||There was only 1 subjected enrolled. The 1 subject was enrolled into Arm - Experimental: C: Moderate Intensity.
747065|NCT00801892||
747066|NCT00801827||7 patients consented to the study but 2 never participated due to scheduling conflicts. All 5 participants that started the study went on to complete the study.
747067|NCT00801801|Protocol Open to Accrual: January 2008, Primary Completion Date: October 2009 and Study Completion Date: March 2011. Recruitment location: University of Alabama at Birmingham.|This study is to evaluate the use of targeted therapy as well as low dose-protracted chemotherapy (metronomic chemotherapy) in patients with advanced or metastatic non-squamous cell lung cancer (NSCLC). There is an increased need for better strategies to improve survival as well as reduce regimen related toxicities for this large group of patients.
747068|NCT00801723||
747069|NCT00801684||
747070|NCT00801632|Participants with end-stage renal disease and no evidence of prior sensitization were enrolled between December 2008 and September 2009.|
747071|NCT00801398||
747072|NCT00801242||
747073|NCT00801229||
747074|NCT00801138||
747075|NCT00801099|All consecutive patients older than 15 years admitted for clean or clean-contaminated (according to Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp.Epidemiol. 1999;20:250-78) interventions.|
747076|NCT00800982|Dates of recruitment were July 2010 through June 2011. Recruitment was performed at the dermatologic medical clinic.|The following treatments for psoriasis required wash-out before group assignment: any type of ultraviolet B phototherapy or topical therapy for 14 days; psoralen and ultraviolet A or any oral or systemic psoriasis treatment for 28 days; alefacept or ustekinumab for 12 weeks, Tumor Necrosis Factor-a inhibitor or monoclonal antibody for 4 weeks.
747077|NCT00800865||There were 36 participants enrolled. Of these, 4 from Group I and 1 from Group II did not have evaluable biopsies and were considered not evaluable. Data only reflect the evaluable population (15 from Group I and 16 from Group II).
747078|NCT00800839|Recruitment Period: September 02, 2008 to December 12, 2011. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.|
747079|NCT00800735||
747080|NCT00800683||
747081|NCT00800540|Participants were recruited from and enrolled at one study center located in Greece.|
747082|NCT00800436||Four participants were counted twice as they were treated in both Cohort 2 and Cohort A.
747083|NCT00800384|First patient was recruited 13 January 2014, last patient was recruited 4 April 2011. All patients were part of the general ICD population at participating sites.|
747084|NCT00800345||
747085|NCT00800254||
747086|NCT00800202||
747087|NCT00800176|Screening period: Week 6 to 5 prior to randomization|As soon as the results of the screening tests were available, eligible patients could start the 4-week placebo run-in period (visit week -4). A diet and exercise plan was discussed based on the recommendations of the investigator. This plan was not to be changed during the study
747088|NCT00799903|The study consisted of a Screening Phase of up to 8 weeks duration, a Treatment Phase, an End-of-Treatment (EOT) visit, and a Follow-up visit scheduled for 35 +/- 7 days after last study drug intake. The median treatment duration was anticipated to be 2.75 years.|During the Screening Phase of the study, participants presenting with chronic Coronary Heart Disease (CHD) were randomized within 8 weeks. In addition to chronic CHD, participants were required to have at least one additional predictor of cardiovascular risk specified in the protocol.
747089|NCT00799825||Subjects in this study come from the primary study (NCT00122681) where they were included in the control group and received Hepatitis A vaccination. The number of subjects that started the study included only those subjects with the vaccine dose administered.
747090|NCT00799773||
747091|NCT00799708|This was a randomized, double-blind, placebo-controlled parallel group study in healthy postmenopausal women. Enrollment occurred from May 2008 through October 2008 across two US Phase I clinical research centers.|
747092|NCT00799643||The Enrollment number in the protocol section (638) is higher than the number of participants Started in the Participant Flow module (286) due to screen failures and drop out prior to randomization.
747093|NCT00799617||
747159|NCT00796419|Critically ill, mechanically ventilated intensive care patients with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) and low blood protein levels were recruited from four hospitals in the Southeast United States between May 1, 2009 and October 31, 2015.|Not all consented subjects were treated due to changes in eligibility between the consent and treatment periods or subject withdrawal from the study after consent but prior to treatment. 31 individuals gave consent to participate in the study, however, 4 did not begin the study intervention, resulting in 27 who started treatment.
747094|NCT00799604|Thirty patients were enrolled at two hospitals. All received an initial dose of clevidipine (Bolus 1-pre-anesthesia) during Treatment Period 1; 21 participants received a second bolus dose (Bolus 2-with anesthesia)during Treatment 2 per the discretion of the investigator at 250, 500 or 125μg, depending on patient response to Bolus 1.|A screening period began up to 14 days prior to study drug administration, consisting of obtaining informed consent, confirming patient eligibility, and collecting screening assessments. Patient eligibility was further verified on treatment day to confirm SPB ≥140 mm Hg prior to study drug. If SBP was <140 mm Hg, no study drug was administered.
747095|NCT00799591|This was a prospective observational study, non-comparative, conducted in 26 French Intensive Care Units (ICUs). Patients who were hospitalized in ICUs and presented with complicated infections of skin or soft tissues or complicated intra-abdominal infections and who met the inclusion criteria of the study were included in the study.|
747096|NCT00799578|Biopsy proven children with nonalcoholic fatty liver disease from fatty liver clinic at University of California, San Diego|Not on other therapy for NAFLD
747097|NCT00799487||
747098|NCT00799474|Data was collected for this cross-sectional study through an online survey. Of the 874 men invited to participate, 609 (70%) completed the online survey. A pilot test was conducted between December 29, 2008 and January 4, 2009, and the main survey was conducted between January 6, 2009 and January 26, 2009.|
747099|NCT00799435||
747100|NCT00799422||In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 1 week before switching to the next assigned product. A 36-hour washout preceded each usage period.
747101|NCT00799409||
747102|NCT00799396||
747103|NCT00799383|Between 02/2009 and 11/2013, medically-healthy 5 to 17 year-old risperidone-treated boys were enrolled, via screening of the electronic medical records, referrals, and word of mouth.|"Participants were required to have been in treatment with risperidone for at least one year.
~They should have had a prolactin concentration ≥ 18.4 ng/ml on two occasions, within one week."
747104|NCT00799292|Enrollment and informed consent was obtained prior to the operation in the gynecology clinic or private offices from 1/2004 - 1/2005.|Randomization occurred at the time of surgery.
747105|NCT00799266|This study was conducted in 12 centers in 6 countries: Australia (1), Canada (5), Hungary (1), United Kingdom (2), Russian Federation (2), and South Africa (1).|The Participant Flow and Baseline Characteristics were done on the Intention-to-treat (ITT) population. All efficacy analyses were done on the Modified Intention-to-treat (MITT) population and all safety analyses were based on Safety population.
747106|NCT00799227||
747107|NCT00798967|First Patient Screened - November 25, 2008; Last Patient Screened - July 13, 2010; First Patient Randomized - March 3, 2009; Last Patient Randomized - July 22, 2010; Locations - hospitals and transplant centers; Subjects must be on parenteral nutrition (PN) and/or intravenous (I.V.) fluids.|Stage 1 was screening, optimization, and stabilization periods. At screening, if the PN/I.V. volume is not stable per protocol, s/he entered an optimization period (up to 8 weeks) to find the minimally tolerated stable volume of PN/I.V.. Prior to randomization, all entered 4-8 weeks of stabilization period on that volume of PN/I.V.
747108|NCT00798889|Participants were recruited from prior studies in which they received sunitinib.|
747109|NCT00798759|Patients were recruited from 22 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for six months prior to Visit 1 were enrolled.|236 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and completed the study (intent-to-treat): 215.
747110|NCT00798720|Recruitment occurred during 2/16/2008 and 03/09/2010.|
747111|NCT00798707||A total of 907 potential participants were screened for this study. 813 participants were enrolled and received single-blind placebo during the screening period prior to randomization.
747112|NCT00798694||
747113|NCT00798655||Study included patients with pathologic stage III or IVA squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or human-papillomavirus (HPV) -negative oropharynx, without gross residual tumor, featuring high-risk factors (margins <1mm, extracapsular extension, perineural or angiolymphatic invasion, or ≥2 positive lymph nodes).
747114|NCT00798603|Sixty-five (65) participants were enrolled between December 12, 2008 and October 1, 2010. Final analysis as of November 6, 2012, was reported.|Three participants who never received any study treatment are excluded from all analyses.
747115|NCT00798590||
747116|NCT00798577||
747117|NCT00798486||
747118|NCT00798434||
747119|NCT00798369||
747120|NCT00798317|First patient was recruited on 23 Dec 2008 and last patient completed the study on 15 Jun 2010|
747121|NCT00798304|In this study, participants were to receive recombinant lipoprotein 2086 (rLP2086) vaccine at 2, 4, 6 and 12 months of age. Due to premature termination of study, only single dose of 20 or 60 microgram (mcg) of rLP2086 vaccine was administered at 2 months and planned treatments of rLP2086 vaccine 120 mcg and 200 mcg were not administered.|
747122|NCT00798174|Patients undergoing Implantable Cardioverter-Defibrillator (ICD) implantation in the electrophysiology laboratory were recruited. Both outpatients (recruited from the electrophysiology clinic) and inpatients (recruited from Barnes-Jewish Hospital) were included.|
747123|NCT00798161||
747124|NCT00798135||
747125|NCT00798096|A total of 18 patients with T-Cell lymphoid malignancy were enrolled in this study from 05 March 2009 until 04 January 2010. As of 19 May 2010, no patients remain on study. All enrolled patients received at least one dose of fostamatinib. This study was conducted at 9 sites in the U.S. and Canada.|There was a screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with fostamatinib treatment for a treatment period of 8 weeks. Patients could continue treatment until disease progression, toxicity or withdrawal from the study
747126|NCT00798018|The study started in November 2008 and finished in February 2009, in total 100 patients were enrolled and all of them finished this study.|
747160|NCT00796367|Subjects were from OB-303 (NCT00553787)|
747161|NCT00796328||Six subjects were withdrawn from the study
747162|NCT00796315||Participant flow is described by three different age groups based on dosing differences for each group
747127|NCT00797966|This study was a Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of OPC-34712 as adjunctive therapy in the treatment of participants with major depressive disorder. This study was conducted in the United States at 50 study centers.|The study consisted of a 28-day Screening period, an 8-Week single-blind placebo + Antidepressant therapy (ADT) prospective Phase A. A 6-week double-blind Randomization Phase (Phase B) or single-blind Phase A+ for those participants who did not meet criteria for randomization and a Follow-up of 30 (+2) days after the last dose of study medication.
747128|NCT00797862||A 2-4 week single-blind placebo run in. 7 patients were assigned a randomization number in error (3 each in the aliskiren/amlodipine initial treatment and aliskiren based add-on regimens and 1 in the amlodipine based add-on regimen). These patients did not take any double-blind study medication and were excluded from the Full Analysis Set (FAS).
747129|NCT00797823|Patients were recruited from the Oregon Health and Science University (OHSU) outpatient clinics in Portland, Oregon.|A total of 22 studies in 14 subjects were performed. 6 subjects participated in 7 9-hour pilot studies, 6 with insulin and glucagon and 1 with insulin + placebo to assess the safety of the protocol. 8 subjects then underwent 2 interventional studies each for a total of 16 studies, one with insulin and placebo and one with insulin and glucagon.
747130|NCT00797797|Participants were recruited and enrolled in this study within the US from December 2008 to June 2009.|Participants entered an open label pregabalin period concurrent with prohibited medication washout. Incomplete responders to pregabalin were randomized to receive either milnacipran (100 mg/d) or no added treatment for 11 weeks. All participant continued background stable dose pregabalin (300 or 450 mg/d) throughout the randomized treatment period.
747131|NCT00797732|Patients were screened for potential enrollment from January 2009 through December 2011.|Since one primary aim was to assess feasibility as measured by recruitment the screening non-randomized count is included in the participant flow.
747132|NCT00797667||
747133|NCT00797563||
747134|NCT00797511|Participants were enrolled from 24 November 2008 to 11 March 2009 at 1 medical center in Taiwan.|A total of 132 participants who met the inclusion and none of the exclusion criteria were enrolled, vaccinated, and evaluated.
747135|NCT00797459||
747136|NCT00797316||
747137|NCT00797277|The study was conducted at 3 psychiatric centers from September 2006 to February 2009.|"A total of 294 patients were assessed initially. Before randomization, 47 patients were excluded, including no signed informed consent (n=20), having received recent depot injection (n=24), no overt agitation after admission (n=180) and newly added benzodiazepine or antipsychotics (n=3)."
747138|NCT00797225|The study was conducted from 26 November 2008 to 24 February 2010 at 27 centers in Central Eastern Europe (Bulgaria, Hungary, Poland, Romania, Russia and Ukraine).|Patients were randomized equally to oral elagolix 150 mg or 250 mg once daily, placebo or leuprorelin acetate (LA) 1-month depot 3.75 mg injection for 12 weeks. Thereafter, patients originally randomized to placebo or LA were re-randomized to 1 of the elagolix doses and patients randomized to elagolix continued their assigned dose for 12 weeks.
747139|NCT00797212||
747140|NCT00797108||
747141|NCT00796991|17 February 2009 study initiated; last patient, last visit (LPLV) 30 October 2012.|72 enrolled; 59 randomized and treated with study drug. Reasons for non-randomization: 7 no longer met study criteria; 3 withdrew consent; 1 had target lesion <1 cm; 1 had screening magnetic resonance imaging (MRI) showed brain metastases; 1 had adverse event.
747142|NCT00796978||
747143|NCT00796926||
747144|NCT00796861||
747145|NCT00796822|Study recruitment, enrollment, and follow-up assessments were performed from May 2009 through October 2011, at the HIV outpatient clinics of the Indiana University Health medical system.|Potential participants underwent a screening visit to evaluate eligibility within 21 days of randomization.
747146|NCT00796757||
747147|NCT00796744||
747148|NCT00796718||A total of 62 participants were enrolled in the study.
747149|NCT00796705|Subject recruitment occurred between November 2008 and November 2010 at 16 sites located in the United States. All sites utilized a rheumatology clinic and outside referrals for recruitment.|Each subject signed an informed consent prior to undergoing any screening procedures. At the screening visit, subjects underwent procedures to establish inclusion/exclusion criteria.
747150|NCT00796666||Participants who successfully completed treatment in study B1321001 (NCT00795639).
747151|NCT00796653||Three patients were randomized but not treated due to withdrawn consent and findings on pre-dose ECG prior to receiving study medication.
747152|NCT00796627||
747153|NCT00796614|The trial included children from 2-16 years of age, with elevated detrusor leak point pressure associated with a known neurologic defect (e.g., spina bifida). The three age strata were 2-<5 years, 5-<10 years and 10-16 years of age. In this study, 231 subjects were enrolled, 162 subjects were randomised and 161 subjects were treated.|
747154|NCT00796562||11 participants were screen failures.
747155|NCT00796549|First patient enrolled on December 23rd 2008 . Last patient enrolled on September 1st 2011. Patients were recruited in Oncology departments of Italian investigational sites|
747156|NCT00796523|Mothers of healthy singleton newborn infants with a gestational age of 37-41 weeks admitted to the normal newborn nursery of a large community hospital were given a flier inviting them to participate by contacting the research assistant by phone.|1408 Fliers were distributed and 51 mothers contacted the research assistant for enrollment in the study.
747157|NCT00796510|Participants were previously enrolled in B1321001 (NCT00795639) or B1321003 (NCT00796666) only where pre-specified entry criteria were met.|
747158|NCT00796445||Some of the enrolled patients did not receive treatment and were excluded from study start (Total Treated population: 1345). Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the TT population-as treated, which included 1344 patients: 894 in the MAGE-A3 Group and 450 in the Placebo Group.
747163|NCT00796302|256 participants were screened. 188 passed screening.|Between initial contact and randomization, 108 potential participants were lost for the following reasons: 68 subjects failed screen criteria, 4 were ineligible at Baseline, 10 withdrew consent, 4 were lost to follow-up, and 2 were unable to swallow medication.
747164|NCT00796224||
747165|NCT00796120||
747166|NCT00796107||
747169|NCT00795886|Patients were recruited between Aug 2003 and Aug 2008 from 4 pediatric centers in the United States. (Childrens Hospital of Philadelphia; Methodist Childrens Hospital of South Texas (San Antonio); Primary Childrens Medical Center (Salt Lake City); and Childrens Hospital of Pittsburgh.|
747170|NCT00795821||The Screening Phase (Week -1 through Week 0) assessed participant eligibility for not less than 3 days and not more than 30 days. At Week 0, those participants who met entry criteria were randomized in a 1:1 ratio to either LY2216684 (dose range 6 milligram [mg] to 18 mg once daily [QD]) or placebo.
747171|NCT00795769||
747172|NCT00795717|Phone contact n=109 Screening n=51 Eligible n=42 Screen failed n=9 Declined participation n=1 Randomized to treatment first n=20 Randomized to placebo first n=21|
747173|NCT00795704|Recruted from April 2008 - Feb 2010 in University of Mississippi Cardiometabolic clinic.|Two week placebo run-in
747174|NCT00795665||
747175|NCT00795639||
747176|NCT00795600|Recruitment from 29-Apr-2009 until 02-Feb-2010. 5 sites in Spain.|
747177|NCT00795535||
747178|NCT00795509||
747179|NCT00795366||
747180|NCT00795340||
747181|NCT00795288||
747182|NCT00795236||The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
747183|NCT00795210|Recruitment occurred between January, 2009 and November, 2012, in the Boston area.|Once patients were found to be eligible (after screen visit) and agreed to participate, there were no additional events prior to baseline.
747184|NCT00795184||
747185|NCT00795145||
747186|NCT00795132||
747187|NCT00795002|All newly diagnosed adults diagnosed with AML were considered for participation.Enrolled on study between November 20, 2008 and July 20, 2010.|2 patients on each arm consented to study, but were screen failures and did not start treatment.
747188|NCT00794963||
747189|NCT00794950||
747190|NCT00794924|February 2004 to january 2005, all patients admitted to the Geriatric Rehabilitation Department of the Harzfeld Geriatric Mdical Center|
747191|NCT00794820|Recruitment Period: All recruitment done at The University of Texas MD Anderson Cancer Center.|
747192|NCT00794677|Recruitment took place in 2007 through search of a clinical research center database, mailings to homes, and posted flyers in the Berkeley, California area.|55 participants screened; 29 excluded because they did not meet inclusion criteria
747193|NCT00794664||One hundred and four patients were screened and 58 randomized in a 2:1 treatment arm ratio.
747194|NCT00794573||
747195|NCT00794560||
747196|NCT00794547||
747197|NCT00794508||
747198|NCT00794469||
747199|NCT00794417|The study consisted of 2 phases: phase 1 and phase 2. A total of 18 participants were enrolled in phase 1 of the study and 42 participants were enrolled in phase 2 of the study. Participants enrolled in phase 1 were not eligible for enrollment in phase 2.|
747200|NCT00794365||
747201|NCT00794313|4 individuals were screened for this study. 3 participants were enrolled in the study. 1 participant screen failed due to inability to reduce/stop Amantadine.|
747202|NCT00794196||
747203|NCT00794170||
747204|NCT00794157||
747205|NCT00794144|Patients at medical clinics in the U.S. participated from October 03, 2008, through December 03, 2008.|negative allergic response; enrollment target met
747206|NCT00794118||
747207|NCT00794040|Recruitment was conducted at the National Institute of Mental Health Division of Intramural Research Programs (NIMH DIRP) from November 2008 until January 2018. The inpatient part of the study took place at the Child Psychiatric Unit of the NIH Clinical Center.|Enrolled participants (N=103) went through a medication wash-out period. n=22 participants withdrew assent before or during this period, and 12 participants met exclusion criteria. Then 69 participants began methylphenidate optimization; of those, 4 withdrew assent, 12 did not meet inclusion criteria. n=53 were randomized, and 49 analyzed.
747208|NCT00793910||
747209|NCT00793871||
747210|NCT00793819||
747211|NCT00793793||
747212|NCT00793780||
747213|NCT00793650||
747214|NCT00793624||Two subjects were randomized but not treated due to withdrawn consent and inability to perform spirometry prior to dosing.
747215|NCT00793611|Patients recruited from the Clinic. Study received IRB approval winter 2008 and recruitment occurred 2008-10.|
747216|NCT00793585|Forty hyperuricemic patients with IgA nephropathy were enrolled in the 1st affiliated hospital of sun yat-sen university between July 2007 and June 2008.|323 primary IgAN patients were screened for enrollment according to inclusion criteria.
747217|NCT00793572||
747218|NCT00793546||Study was pre-maturely terminated after part 1 (safety lead-in phase) of the study and hence, the planned treatments of part 2, bosutinib + exemestane (part 2) and exemestane (part 2), were not administered.
747219|NCT00793520|The recruitment period was from November 2008 to April 2009 at one university location.|Of the five enrolled patients, only two received double-blind study medication due to equipment failure at the study site.
747220|NCT00793455|This trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. This trial was enrolling patients between October 2008 and May 2009.|We used data contained in the clinic's electronic health record to identify eligible patients. All eligible patients were randomly assigned in equal numbers to either the control or intervention arms. All eligible patients were randomized and assigned to groups until we reached target study size.
747221|NCT00793403||
747222|NCT00793325||
747223|NCT00793182|A total of 6 patients signed an informed consent for the study and therefore were considered as included|
747224|NCT00793169|Patients aged 18 years and older presenting to the university for Mohs micrographic surgery for removal of basal cell or cutaneous squamous cell carcinoma of the head and neck were eligible for enrollment.|
747225|NCT00793104|All participants were recruited from the patient population at two investigative sites between 17 November 2008 and 11 June 2010.|There was no group assignment
747226|NCT00792948||
747228|NCT00792922|"The study recruited communities with trachoma rates 20 % or higher from 3 countries - Tanzania, Gambia and Niger.
~Protocol Enrollment refers to the number of communities, not the number of participants enrolled.
~The final analysis was done at community level."|
747229|NCT00792909|This study was an extension study of study 10PN-PD-DIT-002 (105539) for the primed subjects, and a self-contained study for the unprimed subjects.|During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
747230|NCT00792805||
747231|NCT00792701||
747232|NCT00792688|Recruitment started in October 2008 and ended in 2009 at a single site, Clinical Testing Center of Beverly Hills, Beverly Hills, California, United States, 90210.|All subjects needed to meet specific inclusion and exclusion criteria as described in the Eligibility Criteria section. Eligible subjects were randomly assigned to receive GLYC-101 0.1%, GLYC-101 1%, or placebo.
747233|NCT00792636||The number of participants defined as starting the study in the Participant Flow module includes only those participants randomized to treatment.
747234|NCT00792623|Subjects in this study were recipients of autologous peripheral stem cell/bone marrow transplants.|Out of the 45 subjects enrolled in the screening phase of the study, 16 subjects did not receive the study vaccine, as they did not meet eligibility criteria, and were hence eliminated from the study active phase.
747235|NCT00792610|This cohort study was conducted between October 2007 and Jan 2009. The participants were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. They received intervention and blood exam in the hospital.|Initially, 150 seronegative subjects for the three hepatitis B viral markers (HBsAg, anti-HBs, and anti-HBc) were invited to participate in the study. Among them, five subjects were excluded because of seropositive results upon recheck or drop-out. History of complete neonatal HB vaccination could not be confirmed in 18 cases.
747236|NCT00792571|Participants with pulmonary artery hypertension (PAH) who had completed lead in study BPS-MR-PAH-201 were enrolled in this study|A Protocol Amendment was to include an optional arm investigating Beraprost Sodium Modified Release Tablets administered four times daily (QID), however, no participants were enrolled into this arm.
747237|NCT00792428|We advertised in local media, on Craig's list, and informed neurology colleagues and rehabilitation specialists about our trial. Stroke patients had to be at least 5 months out from their stroke and had to have a moderate impairment in their upper extremity weakness.|There were no significant events that occurred after participant enrollment, prior to assignment.
747238|NCT00792298||
747239|NCT00792259||
747240|NCT00792142||
747241|NCT00792116|Researchers and school personnel contacted the parents of all students (n=115) enrolled in an eighth grade math class during the Spring 2008 semester at a charter school in Houston, TX to participate in the current study. A total of 108 (94%) parents provided consent for their children to participate in the study.|
747242|NCT00792103|The study was initiated January 2009 and completed in September 2010. Patients were enrolled from 34 investigative sites across the United States.|This was an open-label study to assess the long-term safety of NP101. Subjects who continued to be in good health and received treatment with an NP101 patch for a qualifying migraine in the pivotal NP101-007 study were considered eligible for enrollment.
747243|NCT00791999|Subjects were recruited in Japan between 2008 and 2010.|Participant flow results are based on the safety set.
747244|NCT00791973|24 subjects were screened for eligibility|15 of the 24 subjects screened were eligible for the study and were randomly assigned to groups
747245|NCT00791934||
747246|NCT00791921|Subjects were recruited in Japan between 2008 and 2010.|Participant flow results are based on the safety set.
747247|NCT00791908||
747248|NCT00791843|Data unavailable for study, PI is deceased and all staff associated with study have left the institution.|
747249|NCT00791817||
747250|NCT00791778||
747251|NCT00791765|Participants were enrolled from 5 December 2008 through 6 January 2010|
747252|NCT00791700|This open-label, multicenter, multiple dose pharmacokinetic, safety and efficacy study at 24 sites in 8 countries.|The participants were HIV-1 infected treatment-experienced children and adolescents who were failing current antiretroviral (ARV) therapy or have failed their most recent ARV regimen, defined by plasma HIV-1 RNA>=1000 copies/mL, were infected with only R5 HIV-1, and have ARV experience/intolerance of 6 months with at least 2 ARV drug classes.
747253|NCT00791661||
747254|NCT00791648||"36 patients consented patients were excluded prior to randomization
~14 withdrew, 12 did not require surgery, 4 had unreported baseline live dysfunction, 2 developed acute coronary syndrome, 2 had statin intolerance, 1 died prior to study intervention and surgery, 1 enrolled in another drug study."
747255|NCT00791557||
747256|NCT00791518||
747257|NCT00791492|Participants who completed study FX-005 (NCT00409175), were eligible for the current study FX-006 (NCT00791492).|
747258|NCT00791479||
747259|NCT00791388||Each Subject enrolled in the study, participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
747260|NCT00791336||
747261|NCT00791323||
747262|NCT00791258|Recruitment occurred at approximately 140 outpatient medical clinics in the United States and South Africa from December 2008 through March 2009. 1406 uncontrolled hypertensive subjects were screened to place 999 subjects into active treatment.|
747263|NCT00791219||
747264|NCT00791128||
747265|NCT00791102||
747266|NCT00791089||All of the 12 participants were assigned to an intervention, but none completed all aspects of the study, because of study termination due to funding withdrawal. Still, basic baseline and outcome measure data was available for 11 of the 12, as noted below.
747267|NCT00791076||
747268|NCT00791037||
747301|NCT00789828|The study was conducted at 24 centers in 10 countries.|A total of 117 participants were enrolled and randomized into the core period. Only 111 participants completing the core period, continued in the open-label extension period of the study.
747951|NCT00757848|First patient enrolled 30 October 2008. Last patient completed 04 August 2009. Study conducted at 15 centres in 6 countries (UK, Germany, Sweden, Poland, Denmark, Russia).|
747269|NCT00790933|Participants took part in study at 298 sites in North America, Western/Northern Europe, Central Europe, Eastern Europe, Asia, Australia and Africa from 22 May 2009 to 31 October 2017.|Participants with a diagnosis of ulcerative colitis and Crohn's disease who participated in previous studies: C13004 (NCT00619489), C13006 (NCT00783718), C13007 (NCT00783692) and C13011 (NCT01224171) and DeNovo participants were enrolled into 1 treatment group, vedolizumab 300 mg, 30-minute intravenous (IV) infusion, every 4 weeks (Q4W).
747270|NCT00790907||All participants (par.) received open-label (OL) fondaparinux (fond.). Par. indicated for percutaneous coronary intervention (PCI) were randomized to low- or standard-dose unfractionated heparin during PCI. Post-PCI, par. could resume OL fond. Par. not indicated for PCI weren't randomized and continued OL fond.
747271|NCT00790868|Participants were recruited and enrolled at Boston University (n = 68), the Institute of Living in Hartford, Connecticut (n = 59), and a combined site of Massachusetts General Hospital and Rush University Medical Center (n = 53). Results presented here are for all sites.|293 individuals completed baseline evaluations. Of these, 98 were deemed ineligible (e.g., other primary diagnosis, medication exclusion) at the initial screening visit. An additional 15 participants were not randomized due to withdrawal (n = 4), lost to follow-up (n = 10), and changes to medication (n = 1). 180 participants were randomized.
747272|NCT00790855|Recruitment Details: 11/6/2008 to 9/1/2010. All recruitment done at UT MD Anderson Cancer Center.|Out of 27 participants registered, two were found ineligible and did not participate in the study.
747273|NCT00790842||
747274|NCT00790803|Five patients with non-infectious uveitis, ongoing for greater than three months but less than twelve months with associated CME. Patients were identified in the PI's regular medical clinic and received five intravitreal pegaptanib doses over the course of thirty weeks.|Five consecutive adult patients with non-infectious uveitis associated CME were chosen for this study. Only patients with a baseline best corrected VA between 20/40 and 20/200, attributable to CME, were selected for the study. In qualified patients with bilateral disease, the eye with the worse visual acuity was selected for the study eye.
747275|NCT00790790||Study Period 1 was an up to 5-week screening phase when participants stopped use of excluded medications (265 participants entered; 118 discontinued). Study Period 2 was a 5-week, double-blind therapy period when randomization and dispensing of study drug occurred. Study Period 3 was a 1-week washout phase when all study medication was stopped.
747276|NCT00790751|Subject recruitment occurred at US investigative sites between November 2008 and April 2009.|Subjects meeting the initial eligibility criteria completed a 4-week non-treatment run-in period during which information on each attempt at intercourse was recorded. At the end of the run-in, subjects meeting the randomization criteria were eligible for assignment to one of the treatment groups.
747277|NCT00790738||
747278|NCT00790699||
747279|NCT00790673||
747280|NCT00790647||
747281|NCT00790582|Patients were enrolled between May 2008 and February 2009. Inclusion criteria were a diagnosis of probable or definite ALS (12), age 21-85 years, forced vital capacity (FVC) greater than or equal to 75% of predicted, and onset of weakness within 3 years. Patients taking riluzole were on a stable dose for at least 30 days.|"This was an open label single-arm Phase II screening trail. All enrolled subjects (n=109) were treated. Their results were compared with placebo subjects from an historical database of ALS placebo patients from recent studies (n=249). Thus the number enrolled (n=109) does not equal the total number of subjects (n=358).
~Enrolled subjects started lithium carbonate at 150 mg twice daily. If subjects did not tolerate a dose it was tapered by 150 mg increments to the maximum tolerated dosage."
747282|NCT00790569||
747283|NCT00790556||For subjects taking anti-hyperglycemic agents and who otherwise qualified for the study, a 4-week washout/run-in period was required prior to dosing.
747284|NCT00790452|Recruitment Period: October 28, 2008 to October 26, 2009. All patient recruitment attempted to UT MD Anderson Cancer Center.|The only participant enrolled was removed from the study due to a drug supply issue, and the study terminated early.
747285|NCT00790400|A multicenter trial conducted at 24 sites in 11 countries. As the primary analysis of the core phase of the study favored everolimus over placebo, an open-label extension phase started: patients randomized in placebo were offered to switch on everolimus and those still receiving everolimus at the end of the core phase could continue the treatment.|The trial had a 2:1 randomization in favor of the everolimus arm. 118 patients were randomized to the core phase of the study. 112 patients received everolimus during core and/or extension phase.
747286|NCT00790335||
747287|NCT00790296|Patients were recruited per referrals from oncology clinics at UCHC and Gray Cancer Center at Hartford Hospital|Two participants signed informed consent but was not randomized as she did not meet study eligibility criteria
747288|NCT00790270||
747289|NCT00790218||
747290|NCT00790205||A total of 14,671 participants were randomized to treatment, provided consent and did not have any Good Clinical Practice (GCP) deviations.
747291|NCT00790192||
747292|NCT00790088|At baseline, few patients had to be excluded from analyses due to major protocol deviations such as missing patient informed consent, CSII therapy for less than 6 months, prior experience with SAP therapy, and no eCRF data information available. Hence 263 patients were eligible for analyses at baseline.|
747293|NCT00790062|There were 1,798 women randomized.|At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups.
747294|NCT00790036|Considering a recruitment period of 53 months and a final primary analysis performed after an anticipated duration of 69 months after study start, 727 patients had to be included. Actual enrolled: 742.|
747295|NCT00790023||
747296|NCT00789997||
747297|NCT00789958||
747298|NCT00789880|From January 2009 to November 2009, three centers in the United States recruited participants 18 to 70 years of age who fulfilled eligibility criteria. Refer to the Eligibility section for more details.|
747299|NCT00789867||
747300|NCT00789854|This was a 3 arm, open-label randomised, rater blinded, parallel group study comparing quetiapine XR monotherapy and augmentation with lithium augmentation in patients with treatment resistant depression, Recruitment period 6 November 2008 to 19 June 2009|At visit 1 and 2 (randomisation) the patients should have a Montgomery-Asberg Depression Rating Scale (MADRS) total score above or equal to 25
747328|NCT00788710||
747302|NCT00789815|The investigator evaluate the inclusion and exclusion criteria of patients undergoing flexible bronchoscopy (FB) at the bronchoscopic room. If patients were eligible, investigator would explain the informed concent, the safety managements and the way of sedation and FB to patients.|If patients or family refused to join the study later or if the intravenous catheter was difficultly placed on the forearm, patients were excluded before assignment.
747303|NCT00789802|129 participants were recruited from November 2008 to January 2010 and follow-up was conducted through May 2010.|
747304|NCT00789776||
747305|NCT00789750|"The safety set includes all randomized participants who took at least one dose of study medication and have at least one post-baseline safety measurement.
~The intent-to-treat set includes all randomized subjects who took at least one dose of study medication, and had a baseline and at least one post-baseline HbA1c or FPG measurement."|There was a lead-in period that occurred after participant enrollment, but before randomization.1538 were screened, and a total of 562 participants were randomized.
747306|NCT00789737|From January 2009 through July 2011, subjects were recruited from medical clinics, private practice and research clinics.|"There was a 2-week placebo lead-in prior to randomization to treatment arm. Participants were excluded if two or more fasting blood glucose readings >240 mg/dL occurred during lead-in.
~Subjects were excluded if there had been oral antidiabetic, significant insulin, or bile acid sequestrant therapy in the 3 months prior to screening."
747307|NCT00789724|Enrollment started in November 2008. During the first 4 months, 33 patients admitted with STEMI were screened and 10 patients were enrolled. One patient withdrew consent to the study on day 2 prior to all assessment and was excluded. The Institutional Review Board then approved enrollment of an additional patient who was enrolled in May 2009.|
747308|NCT00789698||Patients transitioned from the acute phase study (D1050233 -NCT00790192) to the current study (D1050234) in a non-randomized fashion.
747309|NCT00789685||
747310|NCT00789672|Eligibility criteria included age 8 to <18 years, best-corrected visual acuity in the amblyopic eye between 67 and 18 letters inclusive measured with E-ETDRS, fellow eye best-corrected visual acuity of 78 letters or better, and the presence or history of strabismus and/or anisometropia.|At enrollment, subjects were required to have been treated with at least 2 hours of patching per day of daily patching and while on that therapy, have had stable visual acuity (5 letters or one logMAR line of improvement since a previous visit at least 8 weeks earlier)
747311|NCT00789581|The trial was designed to evaluate if doxorubicin+cyclophosphamide (AC) followed by ixabepilone was more effective than AC followed by standard weekly paclitaxel as adjuvant treatment for patients with operable triple negative breast cancer (TNBC). Between Dec 2008 and Jan 2011, 614 women with early-stage TNBC were enrolled from 63 U.S. sites.|Subjects were randomized in a 1:1 ratio to either of 2 arms: 306 to AC/Ixabepilone (Ixa); 308 to AC/paclitaxel (Pac). 489 patients completed all planned treatment with AC/Ixa or AC/Pac.
747312|NCT00789555|Subjects were recruited and enrolled from 69 US study centers.|234 subjects were enrolled under protocol Version 1.0, then exited due to a revision in the study plan. A new cohort of 1026 subjects was enrolled in protocol Version 2.0, for a total enrollment of 1260 subjects.
747313|NCT00789529|Recruitment of patients was conducted by approaching the patients seen in the practice.|32 subjects were recruited and enrolled in the study. No subjects had to be excluded.
747314|NCT00789477|A total of 221 participants were randomized at 39 sites in the US, Canada, and Austria. After the 1 year treatment period, participants were to be followed for safety in a 6 mo. follow-up phase. The last visit for this study occurred in September, 2010.|The study population consisted of men and women aged 18 or older with clinically significant diabetic macular edema (DME) with central involvement, and a best corrected visual acuity (BCVA) of 20/40 to 20/320 (letter score of 73 to 24) in the study eye.
747315|NCT00789438||
747316|NCT00789373||
747317|NCT00789360|Each investigator obtained approval from their IRB for their advertisements and other subject recruitment procedures|"At screening and before administration of Dose 1 in each treatment period, the following were confirmed: forced expiratory volume in 1 second (FEV1) ≥85% of predicted, forced vital capacity (FVC) ≥85% of predicted, and oxygen saturation by pulse oximetry (SpO2)
~≥95% on room air."
747318|NCT00789321|Participants were recruited across 3 Phase I clinical research units in the US. Participants participated from July 2008 to March 2009.|Participants taking anti-hypertensive medications at screening were required to washout of this therapy before randomization and remain off the therapy during the study. Participants were eligible if systolic blood pressure (BP) was ≥120 to <180 mm Hg and diastolic BP was ≥80 to <110 mm Hg at screening (or after 2-4 weeks of washout, if applicable)
747319|NCT00789256|Recruitment for this study was open at Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center - Manchester (NH), White River Junction Veteran's Administration Medical Center, and Integrated Community Oncology Network - Florida.|The intention was to accrue 13 evaluable patients for the initial stages of this study. For each strata, if there were no responders within the first 13 patients, the study would statistically rule-out a response rate of 20% or more with p = 0.05. If there were any responders, the study would accrue an additional 11 evaluable patients.
747320|NCT00789191|48 sites in 8 countries: Canada, Finland, France, Hungary, Slovakia, Republic of Korea, Turkey, and the United States of America (USA)|Between screening and randomisation, eligible subjects were to continue their usual pre-trial oral anti-diabetic drug (OAD) dose and dosing frequency. Subjects on sulphonylurea (SU) treatment randomised to the insulin detemir group had their SU discontinued
747321|NCT00789113||
747322|NCT00789074||
747323|NCT00789035||
747324|NCT00788957|First patient enrolled 27 October 2008; last patient enrolled 05 February 2010. In Part 1, participants with wild-type KRAS metastatic colorectal cancer received open-label rilotumumab and panitumumab to identify a tolerable dose of rilotumumab for Part 2 of the study. Participants enrolled in Part 1 were not eligible for randomization in Part 2.|In Part 2 participants were randomized in a 1:1:1 ratio to the 3 double-blinded treatment arms. In Part 3, participants randomized to Panitumumab Alone in Part 2 and with disease progression or intolerability were re-randomized 1:1 into 2 double-blind groups. Participants completed a safety follow-up visit 30 days after the last dose of study drug.
747325|NCT00788892||
747326|NCT00788827||
747327|NCT00788775|The study was activated on January 23, 2009 and closed early in December 2011 due to slow accrual. Patients enrolled from 8 medical centers beginning March 2009 through June 2011.|
747329|NCT00788697|Study Initiation Date (first subject enrolled): 30 September 2009; Study completion date (last patient completed study related activities): 29 January 2013. The study was conducted at 14 investigational sites throughout the United States (USA) and 1 site in Europe.|"A total of 74 patients received SonoVue in the training phase and were included only in safety population. A total of 263 patients received SonoVue in the efficacy phase. The 74 patients, included within the Not Completed category below, are the training patients."
747330|NCT00788593||
747331|NCT00788372||148 participants were screened, of which 142 participants entered the treatment period.
747332|NCT00788255||
747333|NCT00788151|Study participants were enrolled from 26 September 2008 to 16 August 2010 at 1 clinical site in Peru.|A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study. Two participants were not vaccinated and were excluded from the Full analysis set and Safety analysis set.
747334|NCT00788073||
747335|NCT00788008||200 patients were consented. One person dropped out prior to baseline testing.
747336|NCT00787943|Participants were recruited from the clinic, as well as advertising in the Department of Dermatology.|
747337|NCT00787930|Patients were recruited from 2005-2009 from the inpatient units and Duke University Medical Center and John Umstead Hospital and the outpatient clinics at DUMC.|Only subjects currently in a manic episode were recruited for the acute treatment protocol substudy.
747338|NCT00787917||
747339|NCT00787904||
747340|NCT00787891||In this study, 108 patients completed the 12-week phase (Part 1) and were counted for the primary outcome measure (OM). Patients with healing at Week 12 had the option to continue the treatment for 24 weeks. Among the 87 with healing, 64 enrolled into Part 2. Only 52 had the primary efficacy endpoint available and were included in the primary OM.
747341|NCT00787852|First patient enrolled 3/25/09 and last patient was enrolled 1/4/11. 11 patients enrolled, 10 were treated secondary to 1 patient withdrawing prior to treatment.|
747342|NCT00787839|Atlanta VA patients without known diabetes, who were at high risk of having unrecognized dysglycemia based on age >=45 years, BMI >=25 kg/m2, or other risk factors, were eligible for the study. Patients presenting for primary care visits were approached if they appeared to have age >=45 years and BMI >=25 kg/m2.|
747343|NCT00787800|From 2008 to 2010, patients who were undergoing Implantable Cardioverter-Defibrillators (ICD) device implantation at Mayo Clinic in Rochester, Minnesota and Jacksonville, Florida and at two Israeli medical center sites, Sheba Medical Center in Ramat Gan and Carmel Medical Center in Haifa, were screened for entry into this open-label study.|
747344|NCT00787787|Due to the lack of apparent benefit, the study was closed to further enrollment after the 7th patient was enrolled.|
747345|NCT00787761|24 patients were enrolled between 4/20/2007 and 5/3/2010. Patients who were undergoing transplant at Northside Hospital were potentially eligible.|29 patients signed consent for this study. 2 patients were initially screen failures but eventually were determined eligible & were treated on study. 1 patient was considered a screen failure due to having an ineligible donor. One patient had progressive disease and one patient had compliance-related issues prohibiting them from particiapting.
747346|NCT00787722||
747347|NCT00787644||5 participants did not qualify for randomization as they had a negative methacholine.
747348|NCT00787618||
747349|NCT00787605||
747350|NCT00787566||
747351|NCT00787527|Recruitment Period: 04/03/09 to 12/19/12. All participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.|
747352|NCT00787332|Patients were enrolled between November 2008 and December 2009 from approximately 20 US Medical Centers|Patients were excluded if they had severe renal failure (CrCL<30 mL/min), known allergy to r-hirudins or argatroban, multisystem organ failure, uncontrolled bleeding.
747353|NCT00787319||
747354|NCT00787267|This study opened to enrollment in November 2008 and closed in October 2011 due to slow accrual. Subjects were enrolled at 3 sites: Duke University Medical Center, Durham VA Medical Center, and the University of Minnesota. All subjects were enrolled in Stage 1, in which prior knowledge of each subject's tumoral Src-activity was not known.|
747355|NCT00787254|Participants were enrolled at sites in Japan from April 2007 to May 2009.|Participants were enrolled in either lansoprazole, once daily (QD) or gefarnate, twice daily (BID) treatment groups. NSAID = Nonsteroidal anti-inflammatory drug.
747356|NCT00787241|Women who delivered from 1/2000 thru 12/2002 with the discharge diagnosis of mild preeclampsia, severe preeclampsia and preeclampsia superimposed on chronic hypertension were retrospectively evaluated.|
747357|NCT00787202||
747358|NCT00787189|40 subjects (80 ears) were recruited across two hearing aid and evaluation test sites from May, 2007 to October, 2008.|4 subjects (8 ears) were disqualified because the word recognition score recorded for study qualification purposes exceeded the upper inclusive limit of 86% words correct. 4 subjects (8 ears) were disqualified because the subject's primary spoken language was not English, which was also a study exclusion criteria.
747359|NCT00787150||
747360|NCT00787137|Eight study sites (rheumatology centres) in Serbia (3), Hungary (4) and the Russian Federation (1). The first patient's first visit was on December 2, 2008 and the last visit for the last patient was on April 21, 2010.|The first three patients in each cohort were dosed sequentially and could not be taking methotrexate. Subsequent patients in each cohort could be dosed simultaneously and could be taking methotrexate. There was a pause between dosing the last patient in the first cohort and the first patient in the second cohort.
747361|NCT00787124||
747362|NCT00787020||
747363|NCT00786994|165 patients were recruited.|157 patients were evaluated in the ITT population. 8 of 165 recruited patients were excluded from ITT evaluation due to a deviation from the inclusion and exclusion criteria. For safety evaluations, all 165 patients had received treatment with study medication and all 165 patients were assessed for adverse events.
747364|NCT00786916|This prospective, randomized, double-blind study was conducted at Akron Children's Hospital. The enrollment period was from 4/8/2008 to 2/9/2010.|Patients between 2 and 7 years of age with ASA 1 or ASA 2 classification and scheduled for painless diagnostic procedures were eligible for exclusion.
749762|NCT00671515||
749763|NCT00671502||
747365|NCT00786864|Recruited January 2007 from 2 Government primary schools in the Ekurhuleni West and Johannesburg East Districts of Gauteng|Only children who met the inclusion criteria for the study were included
747366|NCT00786838|This study was conducted in 7 countries: Belgium (3 sites), France (2 sites), India (2 sites), Republic of Korea (4 sites), Russia (4 sites), Spain (1 site), and the United States (4 sites). Total 75 participants were enrolled in this study.|All enrolled participants (ie, 75 participants) received study medication. 26 participants completed the study.
747367|NCT00786825||
747368|NCT00786799||
747369|NCT00786682|Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and a community hospital in New Jersey, part of the CINJ Oncology Group, from February 2009 through August 2010.|
747370|NCT00786643|One community oncology research site in the US within the ACORN Network participated in this study. Phase II enrollment started in February 2006 and was closed in December 2008.|Informed consent was obtained from all subjects. All subjects underwent a screening period during which pre-study assessments were completed. Subjects were assigned to a stratum, based on whether or not they had received previous treatment in the metastatic setting, at the time of study enrollment.
747371|NCT00786565|Recruitment began on 12/15/2004 and ended on 04/28/2006. This study was conducted at 5 European sites.|Planned enrollment was to consist of 120 subjects, due to difficulties in enrolling subjects within the designated 6 month enrollment window 75 subjects were entered into the study for a total of 150 treated eyes.
747372|NCT00786487||we had anticipated enrollment of 36 subjects but ended up finishing the study with 33 subjects
747373|NCT00786474|6585 subjects were screened. 4701 were excluded, 1884 subjects enrolled and underwent randomization.|
747374|NCT00786422|Participants with confirmed acute proximal symptomatic deep vein thrombosis (DVT) or acute pulmonary embolism (PE) were recruited at specialized study sites.|Out of 25 participants screened, 25 participants were assigned to treatment.
747375|NCT00786409||
747376|NCT00786188|Recruitment Period = 29 October 2008 to 26 May 2009 Types of Locations = Research clinics|Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug was administered once daily at bedtime.
747377|NCT00786032|The recruitment process was from 09/01/11 to 04/30/12. After the participants were identified they were sent a letter asking them to participate. After that screening began. The participating sites were Cleveland, Durham, West Haven, Albany, Providence.|Screening qualifications of baseline assessment. The participants had initial contact for interest, consent obtained, and determine electrical environment. If participant passed screening they were enrolled and had to complete training on the device.
747378|NCT00786019||
747379|NCT00785980|Twenty-four (24) healthy, non-smoking, adult male and female volunteers from the community at large were enrolled.|Thirty-nine (39) subjects were screened. Four (4) did not meet eligibility criteria, nine (9) had a schedule conflict prior to Period I check-in, and two (2) transferred to another study.
747380|NCT00785928||Participants received a total of 6 subcutaneous (SC) injections (Weeks 0, 4, 8, 12, 16, and 20) of either placebo or 1 of 6 LY2127399 doses (1, 3, 10, 30, 60, or 120 milligrams [mg]) during the Treatment Phase. The Follow-up Phase took place Weeks 24-44 and the B-cell Follow-up Phase took place Weeks 44-72.
747381|NCT00785798||
747382|NCT00785785||
747383|NCT00785772|Study Initiation Date and Completion Dates: 16 March 2010 to 1 April 2010 Study Center: 1 center in Japan|A subject who had already been taking gabapentin was enrolled in the study.
747384|NCT00785707||
747385|NCT00785629|Single center private practice single specialty clinic, Enrollment Feb 2009 thru September 2010|Consecutive CKD patients with eGFR 20- 45 ml/min with serum Phosphorus >3.5 < 6.0. Stratified by diabetic status. 3 subjects were enrolled but did not receive study medication due to withdrawal prior to starting medication.
747386|NCT00785577||Study Period 1 was an up to 5-week screening phase when participants stopped use of excluded medications (525 participants entered; 252 discontinued ). Study Period 2 was a 5-week, double-blind therapy period when randomization and dispensing of study drug occurred. Study Period 3 was a 1-week washout phase when all study medication was stopped.
747387|NCT00785538|For participants enrolled under Protocol Versions 1.0 and 2.0, there was a 2-week pharmacokinetic (PK) period prior to Cycle 1.|After completion of the 10 milligrams/kilogram (mg/kg) cohort, PK data were obtained that established a recommended dose for Phase 2 studies. Enrollment and dose escalation beyond 15 mg/kg was stopped. Participants with progressive disease (PD) or death were considered to have completed the study.
747388|NCT00785512|The recruitment period was five months, from November 2008 through March 2009.|Patients went through a 4-5 week, single blind, placebo run-in/washout phase, followed by a 12 week single-blind active treatment phase with nebivolol before randomization
747389|NCT00785486||
747390|NCT00785356||
747391|NCT00785291|Between October 2008 - November 2011, a total of 799 participants were recruited.|
747392|NCT00785213|Twenty-three (23) healthy, non-smoking, adult male and female volunteers from the community at large were enrolled.|Thirty-three (33) subjects were screened. Four (4) did not qualify for the study, four (4) did not finish the screening process and two (2) were transferred to another study.
747393|NCT00785044|In the present study MBG313 (NCT00785044), participants previously administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months from the date of administration of 123I-mIBG.|Of 964 heart failure (HF) participants included in efficacy population of MBG311 (NCT00126425) and MBG312 (NCT00126438), 471 participants signed informed consent and enrolled into extension MBG313 study and provided additional efficacy data. New data from MBG313 study combined with data collected in MBG311 and MBG312 studies for efficacy analysis.
747394|NCT00784979||
747395|NCT00784927||
747472|NCT00780741|"Between November 2008 and September 2010, 163 participants with unilateral nasolacrimal duct obstruction (NLDO) were enrolled at 22 clinical centers.
~During the same period, 57 participants were recruited with bilateral nasolacrimal duct obstruction (NLDO), however, these participants are not included in the analyses reported herein."|
747473|NCT00780715||
747396|NCT00784875|LY2624803 was placed on clinical hold by Food and Drug Administration (FDA) on 18 December 2008. The FDA lifted the clinical hold effective 05 May 2009. For analysis purposes, participants who entered into study during 2008 were designated as Cohort 1, whereas participants who entered into study after 2008 were designated as Cohort 2.|None of Cohort 1 participants completed the study and few progressed beyond Period B. The efficacy analyses were conducted using data from Cohort 2 participants only. Participant flow includes participants from both cohorts.
747397|NCT00784849||
747398|NCT00784836||The study expected an enrollment of 150 participants, but terminated after 3 were enrolled.
747399|NCT00784810|Patients were recruited in primary and secondary care in the UK from 6 Feb 2009 to 24 Mar 2010|3-7 day screening, following 7-14 day run-in and a 12 week double-blind treatment period.
747400|NCT00784784|Recruitment period: November 5th to November 19th, 2008 in Toronto, Ontario Canada. Most subjects were healthcare workers employed at a 470-bed acute care facility.|
747401|NCT00784758|Subjects were recruited at six clinical sites using flyers, newspaper, radio and campus advertising, and by contacting participants of prior studies whom agreed to future contacts. The recruitment period lasted from June 2009 to December 17, 2010.|Participants who signed consent and passed screening were enrolled into the study and randomized to a treatment arm. One of 42 active treatment participants withdrew consent after being randomized but prior to receiving treatment. He/she did not provide a reason.
747402|NCT00784719||
747403|NCT00784654||In the Open-label period, 8 subjects completed the Open-label period and were not randomized. Therefore, 157 subjects were randomized in the Randomized Withdrawal Period.
747404|NCT00784641|There were 567 participants enrolled (1134 eyes).|
747405|NCT00784563|After phone screening, we evaluated 104 eligible candidates in-person (90 community responders to newspaper advertisements and 14 clinic patients).|Of the 104 consented candidates, 60 participants started the intervention. Thirty-six candidates did not meet eligibility criteria and 8 declined participation due to time commitment.
747406|NCT00784550||
747407|NCT00784524||
747408|NCT00784459|recruited from asthma patient subject registry|
747409|NCT00784368||
747410|NCT00784303|162 participants were screened for entry into the study, from which 45 were screening failures and 117 entered into the study and were treated.|
747411|NCT00784277|A total of 1000 participants were screened, 598 were randomized, 596 participants received medication in the first part of the double-blind treatment period (IR treatment phase). A total of 463 participants received medication in the second part of the double-blind treatment period (ER treatment phase).|
747412|NCT00784238||
747413|NCT00784225||
747414|NCT00784147|Over the period from late 2008 through early 2010, a total of 113 patients were enrolled into the study from 35 study sites in the United States and Taiwan. The study sites were private medical practices, not-for-profit community clinics and university hospital clinics delivering HIV primary care.|
747415|NCT00784134||
747416|NCT00784095||
747417|NCT00784043||
747418|NCT00784030||
747419|NCT00783965||
747420|NCT00783952||
747421|NCT00783835||
747422|NCT00783796|150 subjects were recruited at 33 sites from the general interventional cardiology population. Dates of recruitment: 12/08/08 through 11/04/09.|Subjects were screened for study eligibility by a member of the study team. Subjects meeting eligibility criteria were asked to sign an informed consent form. Pre-procedure angiography was used for final assessment of eligibility.
747423|NCT00783718|Participants took part in the study at 211 investigative sites worldwide. The Induction Phase contained 2 cohorts. The eligibility criteria for both cohorts were identical. The purpose of Cohort 2 was to provide enough responders to power the Maintenance Phase primary efficacy analysis.|In Cohort 1, eligible patients who met entry criteria were randomized to treatment with double-blind vedolizumab 300 mg or placebo in a 3:2 ratio. All Cohort 2 patients were treated with open-label vedolizumab. In the Maintenance Phase participants were assigned to treatment groups based on their Induction Phase treatment and response to therapy.
747424|NCT00783705|448 subjects were pre-registered through 3 Cancer Prevention Network (CPN) member organizations from 2008 to 2013.|363 subjects were excluded from pre-assignment: 342 ineligible via bronchoscopy, 3 participant decision, 13 lab values out of range, 1 screening time line issue and 4 suspicious of cancer.
747425|NCT00783692|Participants took part in the study at 285 investigative sites worldwide from 23 December 2008 to 08 May 2012. The Induction Phase contained 2 cohorts. The eligibility criteria for both cohorts were identical. The purpose of Cohort 2 was to provide enough responders to power the Maintenance Phase primary efficacy analysis.|In Cohort 1, eligible patients who met entry criteria were randomized to treatment with double-blind vedolizumab 300 mg or placebo in a 3:2 ratio. All Cohort 2 patients were treated with open-label vedolizumab. In the Maintenance Phase participants were assigned to treatment groups based on their Induction Phase treatment and response to therapy.
747426|NCT00783614||
747427|NCT00783432|First observation 24 July 2006 and last observation 28 Dec 2007|Subjects participated in a one-week screening period to identify appropriate subjects based on symptom scores
747428|NCT00783302||885 subjects enrolled in the Study. 874 subjects are in the safety population where adverse event data was collected, 857 subjects are in the efficacy population. 850 subjects completed the study. 35 subjects discontinued the study.
747429|NCT00783289||
747430|NCT00783263||
747431|NCT00783224||
747432|NCT00783198||
747433|NCT00783094||
747434|NCT00782834|Patients were accrued between 7/03/2008 and 9/24/2009 at Fox Chase Cancer Center outpatient medical oncology clinics.|Advanced GIST with measurable disease; previously treated with at least imatinib and sunitinib; a 5-day washout from prior tyrosine kinase inhibitor therapy. Normal cardiac function with LVEF 45% or >, no history of significant heart disease,arrhythmias,congenital long QT sydrome, heart block, MI within 12 mos of visit 1 or unstable angina, CHF
747435|NCT00782821||
747436|NCT00782795|39 screen fails did not go on to randomization|
747437|NCT00782756||
747563|NCT00775645||Of the 437 accrued patients, 27 were ineligible and 1 withdrew consent.
747564|NCT00775606||Two subjects withdrew participation prior to starting study
747438|NCT00782717|Patients were recruited from 41 investigative centers from November 2008 to July 2010. 263 patients diagnosed with diabetic retinopathy and requiring cataract extraction with intraocular lens implantation were randomized.|Of the 263 patients enrolled, 12 exited prior to surgery. Baseline characteristics are presented for the ITT population, i.e., patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit.
747439|NCT00782639|This study was conducted in 4 investigational centers in China. The first subject was enrolled on 24 March 2009, and the last subject completed the study on 06 September 2009.|Phase IV, multicenter, randomized, double-blind, parallel-group comparison of iopamidol-370 and iodixanol-320 in patients at high risk for CIN (patients with Stage 3 or 4 CKD [men: SCr level of ≥1.5 mg/dL; women: ≥1.3 mg/dL or eGFR between 15 and 50 mL/min]) & Diabetes mellitus who would undergo clinically indicated cardiac angiography procedures.
747440|NCT00782626|Pts enrolled from 9 institutions over a two-year period (9/2009-9/2011).|
747441|NCT00782509||644 patients were randomised into the study, however two of the patients were not treated.
747442|NCT00782496||
747443|NCT00782483||
747444|NCT00782418|"First Patient Entered: 19-Sep-2008
~Last Patient, Last Visit: 05-Mar-2009
~1 site"|"Inclusion criteria: Subjects with a Body Mass Index (BMI) of ≤26 kg/m2
~Exclusion criteria: History of diabetes or family history of diabetes.
~Subjects on a carbohydrate restricted diet.
~An amendment added 8 subjects to go before study completion and instituted down dosing for subjects assigned to exenatide 5 μg in the HGC period to placebo"
747445|NCT00782379|Patients were consented between 12/17/08 through 01/13/11. The transplants occured between 1/13/09 and 3/2/11|NA - this study did not use group assignments. All patients received the same preparative regimen consisting of Fludarabine 25 mg/m2 x 5 days, busulfan 110 mg/m2 x4 days, cyclophosphamide 14.5 mg x 2 days PRE transplant and cyclophosphamide 50 mg x2 days POST transplant
747446|NCT00782340||
747447|NCT00782288|All participants were recruited from the Johns Hopkins University in Baltimore, Maryland. The first participant was enrolled on October 13, 2010 and the last participant was enrolled on May 6, 2014. All study visits were completed as of June 2014. There was a DSMB safety review prior to enrolling any subjects into the higher dose group (0.1 mg).|Participants were all consented on a Johns Hopkins IRB approved consent form and screened 2 or 4 weeks prior to enrollment. Enrollment was contingent on meeting all inclusion/exclusion criteria.
747448|NCT00782275|Participants were enrolled between April 2009 and May 2013.|
747449|NCT00782210||
747450|NCT00782184||Participants received 20 mg open-label atorvastatin during a 5-week run-in period.
747451|NCT00782171||From the 280 patients (146/134 immediate/early loading group) who received a study implant 266 patients (138/128 immediate/early loading group) fulfilled all primary and secondary inclusion/exclusion criteria after Implantation. The main effectiveness analysis was performed on this population
747452|NCT00782067|This study was conducted at 29 centers in 12 countries worldwide (Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Norway, Poland, Turkey, United Kingdom, United States).|The Participant Flow was on the Full Analysis Set (FAS), the Baseline Characteristics were done on the FAS and Primary Efficacy Population (PEP). The Efficacy analysis was done on the PEP (except for the Overall Survival which was done on FAS and PEP). The Safety analysis was done on the Safety Set (SS).
747453|NCT00781963|Participants were recruited from among community-dwelling older veterans who responded to an insomnia screening postal survey and who met diagnostic criteria for insomnia. The recruitment period was from May 2010 to February 2012. A total of 519 subjects were enrolled.|Following enrollment, subjects with a Mini-Mental State Exam (MMSE) score < 24 or an apnea hypopnea index (AHI) > 20 were ineligible for randomization. Subjects with unstable medical or psychological conditions were also excluded. Results are presented for the 159 subjects who were randomized (106 intervention and 53 control).
747454|NCT00781950||
747455|NCT00781937|The trial was conducted at 26 sites in the United States and 10 sites in Canada.|Subjects who lost at least 5% of screening body weight after 4 weeks and up to 12 weeks during the run-in were randomised in a 1:1 manner to receive either liraglutide 3.0 mg, or placebo for 56 weeks.
747456|NCT00781911||Participants who completed the study include those who died and had progressive disease.
747457|NCT00781898|Community-dwelling adult volunteers who had been incarcerated and who had a history of opioid dependence.|
747458|NCT00781885||A Protocol Amendment was to include an optional arm investigating Beraprost Sodium Modified Release Tablets administered four times daily (QID), however, no participants were enrolled into this arm.
747459|NCT00781859|First patient was recruited on 30 Dec 2008 and last patient completed the study on 17 March 2010|
747460|NCT00781768||
747461|NCT00781599|Participants were randomized between March and August 2009. Participants were recruited from Swope Health Central.|
747462|NCT00781508|Patients were recruited from the Heart Failure Clinic at MetroHealth Medical Center over a 12 month interval. Recruitment was slow due to the fact that many of the patients were already perscirbed nitrates and so were ineligible for the study.|More than 50 patients had to be excluded due to their already taking nitrates for their heart failure.
747463|NCT00781456|A total of 304 women with menstrually related migraine were screened for enrollment at 37 study centers in the United States. Of the 304 screened, 109 women at 23 centers met entry criteria and were considered eligible for enrollment into the study.|
747464|NCT00781391||
747465|NCT00781365|Recruitment was between March 2009-April 2011. We identified adult patients with elevated BP (systolic BP >140 or diastolic BP >90 mm Hg) at the two most recent primary care visits in the past year using electronic medical records. Patients received up to two mailings followed by phone calls. Further screening occurred in research clinic.|Participants were assigned to treatment group based on their primary care clinic location. Clinics were randomized to treatment or control (cluster randomization).
747466|NCT00781326||
747467|NCT00781274||
747468|NCT00781079||
747469|NCT00780975||
747470|NCT00780962|6,977 patients of 2 Emergency Departments at 2 tertiary care, urban university hospitals (Beth Israel Deaconess Medical Center in Boston, MA and Carolinas Medical Center in Charlotte, NC) were assessed for Eligibility between October 2007 and August 2010.|
747471|NCT00780910||
747474|NCT00780676|Recruitment Period: June 10, 2009 to July 25, 2012. All recruitment performed at The University of Texas MD Anderson Cancer Center.|"Of the 97 participants recruited, 67 were excluded from the trial before assignment to groups. No participants were assigned to MEK Pathway Activity Predictor Positive and MEK Pathway Predictor Negative Arms/Groups."
747475|NCT00780572||
747476|NCT00780559||Participants were excluded from the study prior to assignment for groups (n=12) due to failure of screening (e.g. not meeting inclusion/exclusion criteria, n=10) or declined to participate (n=2.)
747477|NCT00780494|Individuals who were enrolled but did not receive treatment are not included in any reporting.|
747478|NCT00780481||The data for this study was lost. The total number of participants enrolled/completed was pulled from IRB records. Participant age was between 18-65 per protocol. All participants were enrolled in the United States. No other data is available
747479|NCT00780455|Only 4 patients enrolled / 70 patients planned. Study stopped prematurely|
747480|NCT00780442||
747481|NCT00780416||
747482|NCT00780403||
747483|NCT00780338|Participants were all the coalition members and program staff from 12 particiapting coalitions in Maine. Coalition members were enrolled at Baseline (just prior to the AGTO intervention) in April 2009.Each coalition nominated up to five prevention programs to participate in the study.|
747484|NCT00780273||
747485|NCT00780234|243 subjects were consented to provide a pre-screening sputum cytology specimen, and of those, 92 enrolled onto full trial.|243 subjects were consented to provide a pre-screening sputum cytology specimen, and of those, 92 enrolled onto full trial.
747486|NCT00780208||
747487|NCT00780143||
747488|NCT00780026||
747489|NCT00779909||102 potential participants were screened for study eligibility, 61 met various exclusions criteria, and 41 were found to be eligible for randomization. Of the 41 eligible subjects 35 were randomized into the trial. The 6 not randomized were either lost to follow-up or they lost interest and withdrew their consent for further involvement.
747490|NCT00779870||Results of the low number of participants the mild and moderate asthma patients were combined to Non severe group
747491|NCT00779857|Treatment subjects were recruited from the routine clinical referral base of one or more surgeons at each investigational site.|Subjects were screened for enrollment and consented prior to being brought to the OR with the potential that they may not be eligible based on some criteria evaluated in OR (i.e. left atrial size assessed by TEE).
747492|NCT00779779||
747493|NCT00779766|This record provides the end-of-study analysis, including analyses at Month 24, 48, 57 and 72.|Out of the 6081 subjects enrolled, 2 did not have any subject or vaccine number allocated and 28 did not receive any study vaccine dose, hence only 6051 subjects started the study.
747494|NCT00779701||
747495|NCT00779675||
747496|NCT00779584||
747497|NCT00779558||
747498|NCT00779506|From 4 Nov 2008 to 9 July 2009, 96 subjects were enrolled from 9 centers in Korea|
747499|NCT00779467||
747500|NCT00779402||
747501|NCT00779311|Three community oncology research sites across the US within the ACORN Network participated in this study. Enrollment started in October 2008 and was closed early in April 2010 due to two subjects experiencing DLT at the lowest dose level.|Informed consent was obtained from all subjects. All subjects underwent a screening period that could last up to 4 weeks during which pre-study assessments were completed. All subjects received mFOLFOX6, bevacizumab, and sorafenib. Subjects were assigned to a Dosage Level at the time of enrollment.
747502|NCT00779285||
747503|NCT00779259|Twenty-four (24) healthy, non-smoking, adult male volunteers from the community at large were enrolled.|Fifty-two (52) subjects were screened. Ten (10) were screen failures, eight (8) did not return and ten (10) were discharged.
747504|NCT00779246||
747505|NCT00779155||
747506|NCT00779142||
747507|NCT00779116||
747508|NCT00779038||
747509|NCT00779025||
747510|NCT00778999||
747511|NCT00778921||
747512|NCT00778895|Subjects were differentiated according to priming status. Primed Subjects - subjects who had a prior 2-dose priming influenza immunization received a 1-dose vaccination course in the study. Unprimed Subjects - subjects who had not previously received a complete 2-dose priming influenza immunization received a 2-dose vaccination course in the study.|"Study comprised an Active phase of approximately 2 months and a post-vaccination 180 day extended safety follow-up period (ESFU phase).
~374 subjects out of the 390 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria."
747513|NCT00778869||
747514|NCT00778830|First/Last subject (informed consent): February 2009/June 2012. Study completion date: April 2014. Clinical data cut-off: 31 March 2014. Subjects were recruited in 12 countries (Australia, China, Hong Kong, India, Indonesia, Korea, Malaysia, Singapore, Pakistan, Philippines, Taiwan and Thailand) across the globe in 43 centers.|Enrolled: 661 screened for eligibility; 372 were excluded (mainly non-fulfillment of inclusion or exclusion criteria). 289 subjects were assigned to the treatment groups.
747515|NCT00778817||
747516|NCT00778648||
747517|NCT00778622|Started November 2009, Completed March 2011 at Peking University People's Hospital. Participants diagnosed with Type 2 diabetes mellitus 6 months prior to enrollment; were oral antidiabetic agent naive (either having received no antidiabetic agents or received agents 14 days or less, or received none within a month of enrollment in the study.|Participants had glycosated hemoglobin A1c (HbA1c) screening values greater than, equal to 7.0% and less than, equal to 10.0%. Participants were between the ages of 17 and 80 years of age and Chinese Asian. Screening visit was up to 7 days prior to Day 1 (treatment).
747518|NCT00778375|Recruitment Period: October 20, 2008 through October 24, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.|
747519|NCT00778336|Patients presenting at a participating site who were clinically indicated for a peripheral interventional(venous or arterial) procedure with the mid-length (90cm or 120cm catheters) catheter were offered the opportunity to participate. Patients were recruited from January 2007 thru December 2009.|
747520|NCT00778310|A total of 75 patients were enrolled from 11/4/2008 t0 8/12/2010. Patients were recruited from advertisements in local papers as well as flyers in the UTHSCSA psychiatric clinic.|Psychiatric assessment was performed to confirm the diagnosis of ADHD. Fifteen (15) patients were screen failures. Five (5) patients did not respond to an open label trial of Concerta were excluded. 11 withdrew consent or lost to follow up. (1) withdrew to claustrophobia. 43 were exposed to study drug (Concerta and placebo) in crossover design.
747521|NCT00778258||
747522|NCT00778167|Between December 2008 and October 2010, 18 patients were enrolled across cohorts 1 to 3.|Phase I of the study, determining a tolerable dose of IMC-A12 in combination with erlotinib, was completed. Because of concerns about the achievable dose intensity at the maximum tolerated dose, a randomized phase II study that would have involved Arm I in comparing full-dose erlotinib with the IMC-A12 in combination with erlotinib was cancelled.
747523|NCT00778102||
747524|NCT00777946||"This study consisted of a 7 day wash-out period and a 4 week single-blind run-in period prior to the 8 week double-blind period.
~2 of the 820 randomized patients were randomized in error, are not included in the 818 participants enrolled in the double-blind period, did not receive study drug & are not included in the Safety and Full Analysis Sets."
747525|NCT00777920|Participants were enrolled at study sites in Argentina, Australia, Brazil, Canada, Chile, Mexico, Russia, Ukraine, and United States. The first participant was screened on 17 November 2008. The last study observation occurred on 11 September 2019.|140 participants were screened.
747526|NCT00777855|Healthy non-smoking volunteers from community|All participants were medication free throughout study enrollment
747527|NCT00777803||Subjects were randomized according to a ratio of 3:1 to be either treated with IncobotulinumtoxinA (Bocouture®) or with OnabotulinumtoxinA (Vistabel®).
747528|NCT00777790|Subjects were recruited from 20 February 2004 to 08 April 2004 at 9 medical clinics in the US.|A total of 241 subjects that met the inclusion criteria were enrolled and vaccinated.
747529|NCT00777764||
747530|NCT00777634||
747531|NCT00777608||
747532|NCT00777556||Three hundred and seventy-nine candidates were screened.
747533|NCT00777491||
747534|NCT00777335|Subjects were screened and enrolled at 28 sites in 4 countries (USA, Canada, France, Belgium).|
747535|NCT00777296||
747536|NCT00777257|Study participants were enrolled from 26 April 2005 through 24 June 2005 in 21 Medical centers in the US|A total of 1345 participants that met the inclusion and exclusion criteria were randomized and vaccinated.
747537|NCT00777205|Participants were recruited from a total of 15 VA mental health clinics, located within four VA Healthcare Systems and their affiliated Community Based Outpatient Centers.|
747538|NCT00777179|First patient enrolled: 13 October 2008 Last patient enrolled: 7 December 2009 This study was conducted at Division of oncology, Department of Medicine of general hospitals in Korea.|
747539|NCT00777153|423 patients were enrolled in to the study but did not start the study. They did not go on to be randomized.|Randomised=Full Analysis Set (ITT): Cediranib 30 mg=131, Cediranib 20 mg + Lomustine=129, Placebo + Lomustine=65; ITT with measurable disease at baseline (based on site review): Cediranib 30 mg=115, Cediranib 20 mg + Lomustine=112, Placebo + Lomustine=55; Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
747540|NCT00777101||
747541|NCT00777088||
747542|NCT00777062||
747543|NCT00777049||
747544|NCT00777036|Participants were enrolled at 80 sites (Argentina, Australia, Brazil, Canada, France, Germany, Great Britain, India, Italy, Korea, Mexico, Netherlands, Romania, Russia, Singapore, South Africa, Spain, and USA).|A total of 145 participants were enrolled and 130 participants were treated in the study. Reasons for non-treatment include 2 withdrew consent, 1 died, 11 failed to meet study criteria, and 1 other non-specified.
747545|NCT00777023||A total of 565 patients were randomly assigned to treatment: 190 in G-ER 1800 mg group, 192 in G-ER 1200 mg group, and 183 in placebo group. Of these 565 patients, 559 patients (190 in G-ER 1800 mg group, 186 in 1200 mg group, and 183 in placebo group) received study treatment and were included in intent to treat (ITT) and safety populations.
747546|NCT00776997||
747547|NCT00776984||
747548|NCT00776919||
747549|NCT00776789||
747550|NCT00776659||
747551|NCT00776594||
747552|NCT00776555|Shire decided to cancel this study on march 31, 2009 due to changes in business priorities. The study termination was not related to any data or safety concerns.|
747553|NCT00776295||
747554|NCT00776230||
747555|NCT00776100|Four participants were pre-registered between May 2009 and March 2010. One participant was deemed a screen failure due to eligibility reasons and 3 participants have been randomized between October 2009 and March 2010. The study was terminated prematurely on July 16, 2010 due to slow enrollment.|One of the randomized participants was deemed a cancel after going off study prior to receiving study treatment, thus, excluded from all analyses.
747556|NCT00776009||
747557|NCT00775983|Women were recruited for the study at the Women's Options Center at San Francisco General Hospital (SFGH) between October 2008 and February 2010. SFGH is San Francisco's county hospital and serves a diverse and mostly uninsured population.|Of 72 eligible and enrolled participants, 3 did not receive an abortion (2 in the Same-day Dilapan-S group, and 1 in the Overnight laminaria group).
747558|NCT00775944|Participants were recruited between February 2009 and January 2010. 2591 participants were randomised to one of the four treatment groups. Of these, 56 withdrew consent after being randomised and were not included in analyses.|
747559|NCT00775931||
747560|NCT00775684|"Recruitment is now closed for this study. All subject follow-up was completed in the spring of 2012.
~The purpose of the study was to evaluate three medications for the treatment of high blood sugar."|
747561|NCT00775671|Participants answered recruitment advertisments. All qualifying participants had Metabolic Syndrome.|Participants that met inclusion criteria stopped their antihypertensive medications for 3 weeks before study start. All participants took a placebo pill daily for 21 days and had baseline measurements done.
747562|NCT00775658||Three participants withdrew prior to any study procedure: 1 had and upper respiratory infection, 1 required use of oral anti histamine and 1 was lost to follow up
747566|NCT00775528|Subjects were recruited in 9 centers in US between April 2009 and June 2009. During the period of screening (Days -21 to Days -7), subjects were evaluated for eligibility. They underwent a short period of up to 7 days on their usual pancreatic enzyme supplementation before receiving the study treatment.|Nineteen subjects were consented and 18 subjects were allocated to pancrelipase delayed release capsule. One subject did not meet the fecal elastase requirement and did not receive study medication.
747567|NCT00775463|Subjects were recruited across 32 clinical trial sites in the US, Canada and UK experienced in the treatment of systemic sclerosis (SSc) and capable of conducting the trial according to ICH GCP guidance. Subjects were recruited between April 2009 and October 2010.|
747568|NCT00775450|Participants were enrolled from 14 October to 20 November 2008 in 27 medical centers in the US.|A total of 807 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
747569|NCT00775437|Participants were enrolled at 14 investigative sites in the Czech Republic, France, Germany, and the United States.|Participants age 2 to < 4 years or ≥ 4 years and under 15 kg with moderately to severely active polyarticular or polyarticular-course JIA with a parent/guardian to administer injections. The screening visit occurred between Day -28 and Day 0.
747570|NCT00775411||
747571|NCT00775346|Patients were enrolled from 08/19/2008 to 10/14/2008 from 3 medical clinics in the United States.|
747572|NCT00775229|Men and women aged 18 to 75 years with a primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of TTM were recruited through newspaper advertisements and referrals.|Exclusion: unstable medical illness, current pregnancy or inadequate contraception, thoughts of suicide,history of bipolar disorder,dementia, or psychotic disorder,past 12 months SUD, previous treatment with naltrexone, initiation of behavior therapy within the last 6 months, initiation of a psychotropic medication within the last 3months, opiates.
747573|NCT00775203||
747574|NCT00775190||
747575|NCT00775138||
747576|NCT00775021||
747577|NCT00774995||
747578|NCT00774930|Subjects were recruited from multiple sites across countries from May 2009. The study was completed in December 2015.|A total of 153 subjects were screened; 115 were randomized and 38 failed screening.
747579|NCT00774852|Participants ages 16 and older with systemic lupus erythematosus (SLE) who met entry criteria were enrolled into the study between November 2008 and June 2012.|
747580|NCT00774800||
747581|NCT00774787|First patient enrolled - 08 Oct 08; last patient enrolled - 07 Jul 09; last patient completed: 09 Sep 09; Setting - private practice clinics|
747582|NCT00774748||
747583|NCT00774579|Between April 2008 and April 2009 adult hypopituitary patients with untreated GHD were identified and recruited at the endocrine clinics of Imperial College Healthcare NHS Trust.|
747584|NCT00774397||
747585|NCT00774306||
747586|NCT00774267|Participants who had received bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg, bazedoxifene 20 mg/conjugated estrogen 0.625 mg, raloxifene 60 mg, or placebo in the primary study 3115A1-303 (NCT00675688) for up to 2 years and met the eligibility criteria were eligible to enroll in this study.|
747587|NCT00774202||
747588|NCT00774163|Potential subjects were inoformed of the study in community meetings in Santa Clara, Peru. Interested individuals were enrolled at the study clinic between Feb. 23, 2010 and April 2, 2010.|
747589|NCT00774046||
747590|NCT00773968||
747591|NCT00773955|From November 2008 to January 2010, 15 patients were accrued to the study from five sites within the Mayo Clinic Phase 2 Consortium and the California Consortium.|One patient discontinued therapy after one cycle of treatment due to persistent grade 1 thrombocytopenia. Therefore, fourteen patients were evaluable for the primary end point at the interim analysis. All 15 patients were included in secondary endpoint analysis.
747592|NCT00773786||
747593|NCT00773734|The study consisted of a 16-week randomized, double-blind, placebo-controlled phase, and a 8-week active treatment phase. At Week 24, subjects may have continued on active treatment by entering a 28-week extension study, total = 52 weeks; At completion of the extension study, subjects may have entered in a long term extension (LTE) for 5 + years.|Time gaps between the end of one study phase and start of the next phase precluded the continuation of some of the participants in the study.
747594|NCT00773604||
747595|NCT00773513||
747596|NCT00773474||
747597|NCT00773461||
747598|NCT00773422||
747599|NCT00773383||
747600|NCT00773370||
747601|NCT00773279|The trial was conducted at 61 sites in the United States of America (USA).|Screening period of 2 weeks where the subjects were assessed for eligibility, run-in period of 6 weeks, hereafter eligible subjects were randomised to one of the two 12-week treatment sequences: PDS290 -> FlexPen® or FlexPen® -> PDS290.
747602|NCT00773253||
747603|NCT00773175||
747604|NCT00773136|Through study advertisement with IRB approved flyers at the Bascom Palmer Eye Institute, 23 subjects were recruited for initial evaluation. Study recruitment and enrollment began in February 2008 and the study was completed in July of 2008, including 3 month post suspension use evaluations.|
747605|NCT00773097|Patient recruitment took place at the University of Pittsburgh Digestive Disorders Clinic. Start date for enrollment was November 11, 2008 - February 16, 2011|The subjects were excluded if they had a history of a heritable cancer syndrome, autoimmune disease, or a malignancy within 5 years before the enrollment, excluding nonmelanoma skins cancer.
747606|NCT00772967|"First Patient Entered: 23 June 2008
~Last Patient, Last Visit: 20 November 2008
~2 sites"|"Inclusion criteria: Patient has osteoarthritis of the knee and primary source of pain is knee
~Titration schedule for Ultracet® (Acetaminophen 325 mg and tramadol hydrochloride 37.5 mg): twice on Day 1, three times on Day 2, and twice on the morning of Day 3.
~Naproxen tablets 500 mg twice daily on Days 1 and 2 and 500 mg once daily on Day 3."
747607|NCT00772954|Participants were enrolled on 28 March 2006 in 2 clinical centers in the US.|A total of 36 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
747608|NCT00772941||
747609|NCT00772928|Study participants were enrolled from 30 October 2003 to 29 March 2004 in 23 medical clinics in the US.|A total of 1167 subjects that met the inclusion and exclusion criteria were enrolled, 1166 were vaccinated.
747610|NCT00772915|Thirty-nine (39) participants were recruited at Mayo Clinic (Rochester) between December 2008 and April 2010.|One participant canceled prior to starting treatment; this participant has been removed from all analyses.
747611|NCT00772889||
747612|NCT00772772||
747613|NCT00772707|Participants were recruited from 6 US study sites.|
747614|NCT00772668||
747615|NCT00772629|Participants were recruited from 26 January to 29 April 2004 at 2 Medical clinics in the United Kingdom|Eighteen (18) participants that met the inclusion and exclusion criteria were enrolled. One whom no baseline blood sample could be obtained at Visit 1 was not vaccinated and withdrew from the study.
747616|NCT00772603|Adult patients with refractory partial onset epilepsy were recruited from December 2009 to March 2011 at clinical sites in 8 countries.|Patients had at least three partial seizures per 28 days during an 8 week Baseline Period. Subjects were receiving treatment with one to three antiepileptic drugs and were on stable treatment for a minimum of 4 weeks. Subjects with a diagnosis other than partial epilepsy were excluded.
747617|NCT00772590|100 patients were screening at 20 clinical sites in Australia|25 of 100 patients screened did not meet study inclusion criteria and were excluded from study
747618|NCT00772577||
747619|NCT00772538||
747620|NCT00772447|Overall, 265 patients were randomised (daptomycin: 131 patients, comparator: 134 patients), with 264 patients receiving study treatment|
747621|NCT00772382||
747622|NCT00772369|Telephone contact for this study was from 20 September 2003 to 30 April 2004.|A total of 3214 participants that met the inclusion and exclusion criteria were enrolled in this survey. One participant did not return a record release form and twenty-nine (29) others were also excluded from the Primary Analysis Population because their safety data could not be confirmed.
747623|NCT00772304|October 2008- November 2008|
747624|NCT00772148||
747625|NCT00772109|Participants were enrolled from 13 through 30 October 2008 in 50 clinics in the US.|A total of 4276 of the 4292 participants that met the inclusion and exclusion criteria enrolled were vaccinated.
747626|NCT00772070|Study participants were enrolled from 10 march through 13 June 2003 in 8 US clinic sites|A total of 173 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
747627|NCT00772031||
747628|NCT00772005|36 centers in the US. First participant enrolled: September 2008. Last patient completed: March 2010.|The study consisted of a 1- to 2-week screening period, a 24-week double-blind treatment period, and a 7-day follow-up period.
747629|NCT00771953|University Medical Centers and Hospital Based Oncology Programs recruited participants from November 2011 through August 2011|110 patients started a 5 day run in period with 400mg apricoxib. 7 did not complete due to AEs, and 23 did not have at least 50% drop in PGE-M (randomization requirement). Of the remaining 80, 2 withdrew, 2 were ineligible by physician discretion, 1 died and 3 had progressive disease. Thus, 72 patients were randomized.
747630|NCT00771927|Patients were enrolled into 1 of 2 groups in this study (500 unique patients per group) at the discretion of the treating physician: patients treated with Vimpat as add-on to their current Anti-Epileptic Drug (AED) therapy (group 1) and patients treated with other approved AEDs as add-on (group 2).|Patient procedures and assessments were performed in the frame of the current standard practice at the discretion of the treating physician. Each patient was followed for the initial 12 months of add-on AED treatment. A Safety Follow-Up Visit is recommended for any patient who terminates add-on AED treatment before the end of the study period.
747631|NCT00771914||
747632|NCT00771901|Participants will be recruited by reviewing the VFH database pf research subjects and by local postings. Potential subjects will be contacted by telephone for an initial pre-screen, at which time the study is discussed and a brief medical history and concomitant medication list is obtained. ICF will be sent to interested subjects.|Screening tests to determine eligibility included: medical hx & PE, blood tests, resting ECG, OGTT, MRI/MRS/MRE of abdomen/liver, and DEXA scan. Two baseline metabolism studies prior to study drug intervention. There were 67 screen fails, 4 subjects withdrew consent before beginning study intervention.
747633|NCT00771875||
747634|NCT00771849|Subjects were recruited from August 2003 through March 2004 at 2 clinics in the United Kingdom.|A total of 103 subjects that met the inclusion but none of the exclusion criteria were enrolled, 102 subjects were vaccinated.
747635|NCT00771810|Subjects were recruited from Feb2009 to Feb2012 across 10 oncology sites.|
747636|NCT00771758|"The recruitment period for this outpatient, multicenter study occurred between August 28, 2008 and December 9, 2009.
~The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects."|The study consisted of a screening/randomization period (one day) and a double blind active treatment period (10 days).
747637|NCT00771745||
747638|NCT00771667||
747639|NCT00771615||
747640|NCT00771602|Recruitment Period: 08/13/08 through 01/26/10. All participants recruited at UT MD Anderson Cancer Center.|Study was closed early as result of low accrual.
747641|NCT00771537||Message intervention details are in the Brief Summary
747642|NCT00771472||
747643|NCT00771407||7 subjects failed eligibility to continue to protocol-specific surgery after randomization.
747644|NCT00771316|"Phase III
~First patient enrolled on 09-Dec-2008
~Last patient enrolled on 12-May-2009
~The last patient's last visit was 08-Jun-2009
~The study was conducted at 6 study centers in the United States and Europe.
~Study was terminated early due to feasibility issues including slow enrollment."|
747645|NCT00771277||
747646|NCT00771264|Subjects were recruited by investigator sites with limited advertising|
747647|NCT00771238||
747648|NCT00771173|Participants were enrolled from September 2008 through December 2009 at the 2 Loyola system hospitals.|All enrolled patients were randomized to a group. Those patients who were enrolled but not included in statistical analysis was due to inconsistent collection of our primary outcome data. Nursing staff and house staff failed to collect VAS scores consistently.
747649|NCT00771056|Recruitment was from April 2009 through termination December 2011. Patients were identified and enrolled in the CLL Research and Treatment Program where they already were being seen for care of their CLL.|
747650|NCT00770991|Study was open for enrollment at Cleveland Clinic from December 9, 2005 to March 26, 2008. Subjects with FAP who had an assessable rectal segment were screened for potential eligibility. Once it was determined the subjects were potentially eligible they were contacted by phone or letter.|After potentially eligible subjects signed the informed consent, a physical examination with medical history and colonoscopy or sigmoidoscopy was performed as indicated. Blood and urine samples were collected. Subjects with adequate rectal polyp burden and laboratory results within study guidelines were eligible to be randomized.
747651|NCT00770965|A total of 80 participants were enrolled into the study. However, due to audit findings at one site, all 65 participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. The safety set included participants from all other sites.|
747652|NCT00770913|This study was recruited at 71 centers in Japan during the period of 17-Oct-2008 to 12-Nov-2009.|There was no run-in phase before assignment to E3810 treatment groups in this study.
747653|NCT00770874|375 patients were randomized to Arm A (189) or Arm B (186); of these, 364 patients(188 and 176, respectively) received study treatment. 11 patients (1 and 10, respectively) did not receive allocated intervention because of 'withdrew consent(1 and 6, respectively)' , 'ineligible criteria(3 in Arm B)', or 'investigator's discretion(1 in Arm B)'.|
747654|NCT00770861|The recruitment period was one year, from November 2008 to November 2009, occurring at 29 centers in the US and 3 centers in Puerto Rico.|All patients went through a 4 week, single blind, placebo run-in/washout phase before randomization.
747655|NCT00770809||
747656|NCT00770770||
747657|NCT00770757|The study opened to participant enrollment on 02/02/2009 and closed to participant enrollment on 03/29/2011.|
747658|NCT00770692||181 non-elderly & 188 elderly participants were enrolled in the screening period 1 week prior to the first dose. Among these, 20 non-elderly & 24 elderly participants discontinued during the screening period. 161 non-elderly and 164 elderly participants enrolled. 1 elderly participant enrolled for treatment did not receive treatment.
747659|NCT00770679||
747660|NCT00770653|Subjects were enrolled at 61 investigative sites in Germany from 03 April 2007 to 13 May 2009.|Subjects with type 2 diabetes with diabetic dyslipidemia, inadequately controlled by Metformin monotherapy were enrolled in one of two, twice-daily (BID) combination therapy treatment groups.
747661|NCT00770588|A total of 298 patients were screened for the study and 296 subsequently randomized|
747662|NCT00770562||
747663|NCT00770510|This study was recruited at 21 centers in Japan.|Of the 192 participants who entered the screening period, 72 were randomized to study medication (excluding 119 ineligible participants; one withdrawal of consent).
747664|NCT00770484||
747665|NCT00770432||
747666|NCT00770367|medical clinic, 36 participants recruited|After informed consent, a laboratory specimen will be obtained at the visit, including a pregnancy test (if indicated), and the screening ADMA level. This information will be used to determine study eligibility. Screened participants will be eligible if their ADMA > 0.50 μM/L. If not eligible would be excluded from study.
747667|NCT00770341||
747668|NCT00770328||
747669|NCT00770315||
747670|NCT00770289||
747671|NCT00770224||
747672|NCT00770211||
747673|NCT00770146||Five hundred and seventy-seven patients were screened and 158 patients were randomized at 43 study centers in a 2:1 ratio to receive mipomersen or placebo once a week for 26 weeks. Participants who finished treatment or who discontinued prematurely from the study for any reason were assessed for safety for 24 weeks after the last study drug dose.
747674|NCT00770133|There were 70 eyes in the KetoNaph group, 72 in the ketotifen group, 70 in the naphazoline group, and 70 in the vehicle group, for a total of 282 eyes (141 subjects).|
747675|NCT00770120||
747676|NCT00770029||
747677|NCT00769886||
747678|NCT00769860||
747679|NCT00769808|Seventy two myopic participants (144 eyes) were enrolled.|
747680|NCT00769704|"Eligible patients were adults with histologically confirmed, not surgically resectable, stage IIIB - IV melanoma suitable for direct or ultrasound-guided injection.
~Among those randomized, the first patient enrolled 29 April 2009 and last patient enrolled 8 June 2011.
~1 patient randomized 3 times is counted once under talimogene laherparepvec."|Patients were assigned at a 2:1 ratio using central random assignment to receive intralesional talimogene laherparepvec or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). Randomization was stratified by site of first recurrence, presence of liver metastases, disease stage, and prior nonadjuvant systemic treatment.
747681|NCT00769652|Eight subjects were enrolled from October 2006 through May 2007 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center.|1 subject was consented but did not get randomized.
747682|NCT00769600||
747683|NCT00769561|Location: Department of Prosthetic Dentistry and the Department of Oral and Maxillofacial Surgery, Marburg Dental School, Philipps University of Marburg, Germany Patient recruitment and follow-up assessment period: August 2008 to April 2011.|
747684|NCT00769483|Completed, last patient enrolled in September 26th, 2013|
747685|NCT00769392||28 participants enrolled in this study. Once 24 subjects completed the study, the remaining 4 subjects were not required to complete the study, therefore, their data was not collected for this analysis.
747686|NCT00769314|Patients were screened beginning March 2007 and the last patient was treated in October 2008. The study was conducted at 47 sites in Australia, the Czech Republic, France, Germany, Poland, the United Kingdom and the United States.|Per protocol, a total of 1950 patients were to be randomized. Following randomization, patients were not to start treatment until a new labial herpes episode occurred. Thus, of those randomized, only 780 patients were planned to be treated (390 patients per treatment group) and 1170 patients were to be randomized, but not treated.
747687|NCT00769184||
747688|NCT00769132|"Phase I
~First Patient Entered 16 Aug 2007.
~Study conducted at Comprehensive Phase One, Miramar, FL. and Cedra Clinical Research LLC, San Antonio, TX."|
747689|NCT00769119|First patient enrolled 25 September 2008. Last patient completed 20 April 2009. Study conducted at 6 centres in Canada and 4 centres in the UK.|
747690|NCT00769067||
747693|NCT00768989|Participants were enrolled from sites in Argentina (n=21 randomized), France (n=26 randomized), and the United States (n=47 randomized).|Of 167 participants enrolled, 94 were randomized to treatment; 1 withdrew consent after randomization but prior to study dosing. Of the 73 not randomized, 5 withdrew consent, 1 lost to follow up; 1 poor/noncompliance; 61 no longer met study criteria, and 5 for other reasons. The trial was terminated early.
747694|NCT00768898|30 subjects with conjunctival staining and no other ocular pathology were recruited and enrolled.|This reporting group includes all enrolled participants.
747695|NCT00768755||
747696|NCT00768716||
747697|NCT00768651|Recruitment period took place between March 2010 thru October 2010. Consent took place in the Clinical Islet Transplant Program at the University of Alberta.|Patients signed Informed Consent after a consultation with the PI. Then they proceeded through the evaluation phase of the study. During this phase, some patients were excluded based on the protocol's inclusion and exclusion criteria (i.e. lab reports or procedure that did not meet protocol standards).
747698|NCT00768599|One-hundred and ninety-eight (198) subjects were screened and 135 were enrolled/randomized in the study. Subjects with negative KOH evaluations in both regions (all scrapings negative) were considered Screen Failures and were not enrolled into the study. Subject enrollment and completion dates are March 27, 2008 - September 25, 2008.|Subjects who met the inclusion/exclusion criteria were randomized to receive Econazole Nitrate Foam 1%, Econazole Nitrate Cream 1%, or Foam vehicle in a 1:1:1 ratio.
747699|NCT00768560|47 subjects were recruited from 30 Jan 2008 to 11 May 2008 by 3 centers in Japan.|After a 4-week baseline treatment with Adalat controlled release (CR) 40 mg once daily (OD), 35 subjects were randomized to double-blind treatment and were included in the safety analysis. 34 subjects were included in the analysis of pharmacokinetics, efficacy and demographic data. 1 subject discontinued the study in Period 1 due to adverse event.
747700|NCT00768521|"First Patient Entered: 8 Sep 2008
~Last Patient, Last Visit: 19 Jan 2009
~2 sites Since Part I of the study enrolled sufficiently there was no need to modify the study design nor conduct Part II."|"Patients completed a 1-week screening and 1-week placebo run-in period.
~Patients were randomized Visit 3/Day 1. Patients were excluded if they were unable to adequately complete a diary, number of micturitions was ≤ 8, or number of urge incontinence was ≤ 1 on each diary day."
747701|NCT00768469||
747702|NCT00768430|The study enrolled patients at two academic sites, Baylor College of Medicine and Icahn School of Medicine at Mount Sinai, between November 2010 and August 2012.|The protocol required patients to be drug free prior to the infusion, for at at least 1 week (4 for fluoxetine) for those taking other medications. Randomly assigned in a 2:1 ratio, the patients received a single intravenous infusion of ketamine hydrochloride (0.5 mg/kg) or midazolam (0.045 mg/kg) infused over 40 minutes.
747703|NCT00768300|Participants were enrolled in a total of 136 study sites in North and South America, Europe, and Australia. The first participant was screened on 10 December 2008. The last participant observation was on 28 February 2011.|494 participants were randomized; 492 participants were treated, and comprise the Safety Analysis Set and the Full Analysis Set.
747704|NCT00768287||Subjects could enter the study at any part and could leave at any time. Of the 77 subjects in the total study population, 32 entered during the PK part, 35 entered during the Treatment part, and 10 entered during the Surgical Substudy. Nine subjects participated only in one Part: 3 only in the PK study and 6 only in the Surgical Substudy
747705|NCT00768261||39 subjects enrolled in Group3.14 maps have passed inspection for quality and are included in final analysis. Subject data from a previously published study of donepezil(Wang et al.,2010) with 18 very mild dementia of the Alzheimer's type patients treated with donepezil,14 untreated with mild DAT, and 56 cognitively normal individuals are included.
747706|NCT00768248|Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.|
747707|NCT00768222||
747708|NCT00768144|Participants were recruited from the GYN Oncology clinics at the DFCI, MGH and BIDMC. Thirty six consenting participants were enrolled over a 19 month period.|
747709|NCT00768118||
747710|NCT00768079|A total of 110 participants were randomized in the study.|
747711|NCT00768066||
747712|NCT00768053||Study duration includes a screening period of up to 6 weeks, a 12 week open-label treatment period, and a 4 week follow-up period (telephone contact for the assessment of adverse events).
747713|NCT00768040||
747714|NCT00767819||Seventy-four patients were screened and seventy-one enrolled.
747715|NCT00767806||
747716|NCT00767767||
747717|NCT00767676|Healthy adult volunteers, 18 years of age and older|
747718|NCT00767624||
747719|NCT00767572|Patients were recruited from the UCSF Adult Congenital Heart Disease Clinic between July 2008 and July 2009. All reviewed the study protocol and agreed to participate. There was no compensation for study participants.|Patients were excluded if they did not have prior repair of aortic coarctation or could not participate in all 4 study visits.
747720|NCT00767520||
747721|NCT00767507|This study enrolled patients with acute coronary syndrome (ACS) or who had previously received stents, who were required to discontinue maintenance oral P2Y12 therapy before cardiac surgery. Patients who had discontinued oral therapy within the previous 72 hours were eligible. Patients were hospitalized during the enrollment period.|"Stage I was an open-label, dose-finding stage to identify the dose of cangrelor that achieved a level of antiplatelet effect after discontinuation of oral P2Y12 therapy equivalent to the previous oral P2Y12 maintenance therapy. These patients were not enrolled in Stage II.
~Stage II was randomized, double-blind, placebo-controlled."
747722|NCT00767455|Healthy volunteers >= 18 years of age|
747723|NCT00767364||
747724|NCT00767338||
747725|NCT00767325||A total of 164 participants were screened; 104 were enrolled in the study and received open-label treatment with abatacept.
747726|NCT00767104|Subjects were recruited for this study from 10/01/08 through 11/25/08. Cable TV advertising was the route of recruiting subjects and our patient database at Wake Forest University Dermatology Clinical Studies.|
748136|NCT00748709|"The trial was terminated earlier than planned because of a high screen-failure rate and recruitment challenges that prevented full accrual; no safety or efficacy findings influenced this decision. "|
747727|NCT00767039|Patients born between 1/2005 and 5/2008 with respiratory distress syndrome requiring mechanical ventilation, <30 weeks gestation, greater than 500 g and whose parents provided informed consent were included in the study. Infants with multiple congenital anomalies, significant congenital heart disease were excluded.|
747728|NCT00767000||
747729|NCT00766831||
747730|NCT00766753||
747731|NCT00766727||
747732|NCT00766675||
747733|NCT00766649||
747734|NCT00766636|Recruitment Period: September 4, 2008 to December 7, 2009. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.|Of the 5 participants enrolled, one withdrew consent and the others did not complete treatment.
747735|NCT00766597|Nine participants were recruited in 9 US sites between Sept 21, 2009 to June 16, 2010 prior to the early study closure on August 10, 2010.|In Step I, 9 participants under Cohort I were screened for evaluation for co-receptor tropism. Five participants did not have the required tropism and were discontinued from the study. Only 4 participants had the CCR-5-tropic virus tropism, and thus were eligible to go to Step II and were assigned to receive the study drug.
747736|NCT00766532|Postmenopausal women with early stage breast cancer and planning to start aromatase inhibitor therapy.|Participants completed a four-day food diary
747737|NCT00766506||
747738|NCT00766493|This study will be conducted at a maximum of 40 medical institutions in the United States (including public and academic research center hospitals and private practices) and will enroll approximately 250 subjects.|
747739|NCT00766467|Study activated at Dana-Farber Cancer Institute in August 2008 and was eventually activated at Beth Israel Medical Center , Dartmouth Hitchcock Medical Center, and University of California San Diego. The study closed to new accrual as of April 2014 as the accrual was met.|Randomization was performed by the Quality Assurance for Clinical Trials office at the Dana Farber Cancer Institute. Patients were randomized in a 1:1 basis to each treatment arm with no stratification.
747740|NCT00766415|84 patients enrolled, 52 were randomised, 1 patient discontinued before treatment start and 51 patients completed the study. First patient entered the study on 17 November 2008 and the last patient finished the study on 10 June 2009.|
747741|NCT00766376||
747742|NCT00766363|The recruitment period was from September 2008 to February 2009 at 4 study centers in the US (CA, FL, and 2 in NJ).|61 subjects were screened and 49 subjects were enrolled.
747743|NCT00766116||
747744|NCT00766090||Eligible participants (par.) at screening entered a 14-day Run-in Period. Par. were then randomized to 1 of 12 sequences: 6 had placebo and two doses of fluticasone furoate (FF), and 6 had placebo and two doses of fluticasone proprionate (FP) (allocation ratio of 7:2 [FF:FP]). 320 par. were screened and 190 were randomized.
747745|NCT00766051|12 infants were recruited for the study. Later, matched historical controls were utilized for comparison (Nov. 2007-March 2010).|There were no group assignments. This study was quasi-experimental as matched historical controls were utilized.
747746|NCT00766038||
747747|NCT00765999||Of the 1559 enrolled participants, all but 5 also received study drug, leading to an overall safety population of 1554 participants.
747748|NCT00765947||
747749|NCT00765895||
747750|NCT00765882|Patient Recruitment occurred from October 2008 to March 2009 at 103 study centers (95 in the United States and 8 in Canada).|Patients went through a 14 to 21 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS).
747751|NCT00765856||
747752|NCT00765843||
747753|NCT00765817||Two subjects who started the study, subsequently withdrew prior to receiving study medication and are not part of the full analysis set
747754|NCT00765765|Six subjects were recruited from The Cancer Institute of New Jersey (a comprehensive cancer center) and one of its affiliate community hospitals in New Jersey, from April 2009 through June 2010.|
747755|NCT00765726||
747756|NCT00765674||In the single-blind period, 1909 patients were enrolled, 1189 completed, and 720 discontinued. Of the 1191 randomized patients, 2 patients were randomized by error and discontinued in the single-blind period without taking double-blind medication.
747757|NCT00765661||
747758|NCT00765648|Eligible patients had 2 systolic blood pressures(BP) measures > 180 mmHg at least 10 minutes apart, and no contraindications.Emergency room setting.|
747759|NCT00765570|Subjects were screened and enrolled from the physicians offices at Summa Health System.|
747760|NCT00765388|Subjects where recruited by 6 stoma care sites in UK|No pre-assignment details
747761|NCT00765375||
747762|NCT00765362||
747763|NCT00765336||
747764|NCT00765245|This study began enrolling patients October 2008 and continued until November 2013 when its study accrual goal was met. Patients were recruited from two academic medical institutions, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center and the University of North Carolina Medical Center, Chapel Hill.|Fifty-one patients signed consent to participate in this trial. Seven patients did not meet eligibility criteria, thus they did not receive treatment therapy and continue on study.
747765|NCT00765232|Patients were recruited from October 2008 to November 2010.|
747766|NCT00765206||60 participants were enrolled: 30 participants were randomized to 1-Day Dosing and 30 participants were randomized to 7-Day Dosing. This was a crossover study, ie, participants in both groups received one treatment [Zegerid or Prilosec], followed by a 2-week washout period, followed by the other treatment [Prilosec or Zegerid].
747767|NCT00765193||
747768|NCT00765128|Patients were recruited from October 2008 to November 2010.|
747769|NCT00765102||Stratum 1 (bortezomib resistant) had 19 participants. Stratum 2 (non-bortezomib resistant) had 13 participants.
747770|NCT00765076||
747771|NCT00765063|This was a follow-up study of A6301083 (NCT00662831)|
747772|NCT00765037||
747773|NCT00764946||
747774|NCT00764881|The date of first subject was 29 Jan 2009. The date of last subject was 20 Jul 2010.|Of 276 participants screened, 29 failed Screening, and 217 were randomized 1:1, of which 1 never received treatment, 3 had no observations, and 213 were treated (EV/DNG=106; EE/LNG=107).
747775|NCT00764868|Subjects had to have satisfied all entry criteria for the antecedent study (SPD489-305, NCT00735371) and completed a minimum of 3 weeks of double-blind treatment and reached Visit 3 of the antecedent study (SPD489-305), without experiencing any clinically significant adverse events that would preclude exposure to LDX.|269 subjects were enrolled, but 4 were not dosed during the study and thus excluded from the Safety Population.
747776|NCT00764790||
747777|NCT00764751||
747778|NCT00764738||
747779|NCT00764699||
747780|NCT00764673||
747781|NCT00764660||
747782|NCT00764517||
747783|NCT00764504||
747784|NCT00764478||
747785|NCT00764465||
747786|NCT00764361|subjects were recruited through the local veterans administration clinics|adult subjects with diabetic lower extremity ulcers were enrolled into the study after determination that the wound was not infected
747787|NCT00764322|Participants were recruited from breast cancer patients at Lineberger Comprehensive Cancer Center who had received tamoxifen for at least 4 months.|One patient was a screen failure
747788|NCT00764309||Of the 47 participants enrolled, 31 were treated. Reasons for not entering treatment period were: withdrew consent-1, lost to follow up-2, no longer met study criteria-12, other reasons-1.
747789|NCT00763971||
747790|NCT00763958|Recruitment began in May of 2008 and ended June of 2010. All participants were recruited from a 28-day drug inpatient facility that accepts patients from the criminal justice system.|Initially, 11 women were enrolled in the open-label trial, followed by 33 women randomized to either buprenorphine or placebo.
747791|NCT00763919||
747792|NCT00763867||
747793|NCT00763815|The study was conducted at 150 centers in 13 countries between September 29, 2008 and June 29, 2011. The overall duration of treatment was at least 76 weeks (24 weeks main double-blind treatment; variable double-blind extension treatment).|A total of 906 patients were screened of which 422 (46.6%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 484 patients were randomized.
747794|NCT00763750||
747795|NCT00763698|The study was conducted at 18 investigational centers located in the United States (US). The first patient was enrolled on October 30, 2008 and follow up was completed on May 31, 2009.|All patients were included in the study analysis with the exception of patients who underwent unsuccessful implantation of the 1258T lead system. These patients were followed for a period of 30 days and then were withdrawn from the study.
747796|NCT00763490||
747797|NCT00763451|The study was conducted at 75 centers in 15 countries between September 29, 2008 and January 27, 2011. The overall duration of treatment was at least 76 weeks (24 weeks main double-blind treatment; variable double-blind extension treatment).|A total of 884 patients were screened of which 400 (45.2%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7 percent [%] and less than or equal to 10%). A total of 484 patients were randomized.
747798|NCT00763412||
747799|NCT00763386|Patients were enrolled between June 2001 and December 2007 at a total of 12 sites throughout the US/Canada|
747800|NCT00763360|Patients were undergoing a cataract operation and were recruited from surgery during 2008 to 2010|Patients were screened prior to cataract operation
747801|NCT00763321||Out of the 287 participants enrolled in the study, 285 participants were treated; 2 participants did not receive treatment during the open-label treatment period.
747802|NCT00763282||
747803|NCT00763269|subjects were recruited by the PI at the clinical site|subjects were screened for medical and oral health criteria and then entered a 1 week washout before study treatment period.
747804|NCT00763256|all subjects were recruited at the clinical site by the PI.|All subjects passed a medical exam and met the inclusion/exclusion criteria.
747805|NCT00763243|Subjects were recruited over a 2 year period from a database of families whose children had received cochlear implants at a large university-based teaching hospital and who had consented to be contacted for participation in research studies.|All eligible subjects were assigned to Cogmed working memory training.
747806|NCT00763139||
747807|NCT00763061|111 patients were enrolled in this study at 4 hospitals|Eligibility patients were washed out for up to 4 weeks before randomization
747808|NCT00763048|subjects were recruited by the PI at the clinical site|Subjects were screened to meet medical and oral health criteria and then began a 1 week washout period with fluoride toothpaste.
747809|NCT00763035||
747810|NCT00763009|Study terminated due to difficulty enrolling|Study terminated due to difficulty enrolling
747811|NCT00762996||
747812|NCT00762970||Of those 150 screened subjects, 3 were not eligible to participate in the study and 10 were not randomized to the study lens groups. 115 subjects completed all study visits without a major protocol deviation.
747813|NCT00762931||
747814|NCT00762892|approached patients HIV positive, naive to therapy, single site, English and Spanish speaking/writing.|
747815|NCT00762853|subjects were recruited by the PI at the clinical site|Subjects were screened for medical and oral health criteria and then began a 1 week washout period with fluoride toothpaste.
747816|NCT00762788||There were 350 subjects recruited with 314 subjects being dispensed lenses. These 36 subjects were excluded due to failing to meet inclusion criteria.
747817|NCT00762762|all subjects were recruited by the PI at the clinical site.|all subjects pass a medical exam and meet the study inclusion/exclusion criteria.
747818|NCT00762723||
747819|NCT00762710|Recruitment began in January 2008 and ended June 2014. Six hundred and one people responding to flyers and newspaper advertisements and contacted the study, 151 provided informed consent, and 19 women and 73 men (N = 92) were randomized. Both civilian and veteran participants were seen in an outpatient VA clinic.|"Of the 151 consented into the study, 59 did not go onto be randomized because of the following:
~Declined after screen (N=11) (includes missing baseline/first medication appointment) Ineligible at screen (N=48)
~PTSD (N=11)
~Acute illness (N=7)
~Drug dependence (N=4)
~Drinking inclusion not met (N=20)
~Other (N=6)"
747820|NCT00762645|30 patients were enrolled in this study|Patients randomized at 1:1 ratio into two treatment groups
747821|NCT00762619|subjects were recruited by the PI at the clinical site|subjects were screened for medical and oral health criteria and given the assigned study treatment to brush with for the next 6 months. Enrolled subjects all had 1 dental implant and 1 natural tooth identified and used for clinical data information.
747822|NCT00762606||
747823|NCT00762528|subject recruitment will be completed by the PI at the clinical site.|Subjects are screened for plaque, bleeding and gingivitis scores before being assigned to any Study Treatment. Study Treatment randomization is balanced across the two treatment groups and is accomplished by stratification of subjects by gender (male & female) and baseline gingivitis (GI) scores.
747824|NCT00762515|subjects recruited by the PI at the clinical site.|Screening for subjects that met the overall oral health criteria. Followed by a 1 week washout prior to starting any study treatments or procedures.
747825|NCT00762502|Recruitment occurred at 1 site in the USA (n=50 enrolled), and 7 sites in Australia (n=62 enrolled)|Total of 112 subjects enrolled, 77 subjects completed study after 3 months. The study was then restricted down to two sites (Australia only) after 3 months with only 37 of the 77 being included. There were 36 subjects whom completed the full 6 month trial period.
747826|NCT00762476||
747827|NCT00762463||
747828|NCT00762450|subjects are recruited by the PI at the clinical site|subjects are screened for medical and oral health criteria and start a 1 week washout period.
747829|NCT00762424||
747830|NCT00762411||
747831|NCT00762385||
747832|NCT00762372||
747833|NCT00762359|Participants were enrolled at sites in Japan from May 2007 to November 2008.|Participants were enrolled in either lansoprazole, once daily (QD) or gefarnate, twice daily (BID) treatment groups.
747834|NCT00762320|Patients weighing 15kg and able to swallow pills, currently taking liquid lpv/rtv were recruited from an outpatient pediatric HIV clinic from 4/1/2009 through 1/12/11|
747835|NCT00762268||
747836|NCT00762229|Patients were recruited from themedical, cardiology and lipid clinics from Spetember 2007 through April 2008.|The drug was prescribed once daily. No patients were excluded after randomization
747837|NCT00762216|79 eyes of 71 patients were enrolled into the study. 10 eyes (6 patients) were excluded from analysis for astigmatic keratomy outside of the protocol requirements|non-randomized
747838|NCT00762177|subjects were recruited by the PI at the clinical site|Subjects were screened for medical and oral health criteria and then entered a 1 week washout.
747839|NCT00762164|Thirty-four patients were randomized from August 2007 through October 2008. Patients were recruited from our cardiology and lipid clinics.|There was no washout phase during the study. No patients were excluded after enrollment.
747840|NCT00762086|Between March 2009 and August 2011, a total of 67 patients were screened and randomized into the study. Patients were recruited from private clinics and clinics affiliated to University Hospitals|Subjects were required to be treated with Aspirin/Clopidogrel for at least one week priot to 1st treatment
747841|NCT00762073||
747842|NCT00762034||
747843|NCT00762021|Uncomplicated age-related bilateral cataract with the potential to see 20/40 or better in each eye|During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
747844|NCT00761969|"This study was conducted by 85 primary care physicians-researchers from Slovenia, acountry with a population of about 2 million. Participating physicians were educated on cardiovascular disease prevention according to the European guidelines attended annual progress report meetings and were visited at least once a year by a study monitor.
~."|
747845|NCT00761956|Patients were enrolled between 2004 and 2008 at a total of 15 sites throughout the USA|
747846|NCT00761930|subjects were recruited by the PI at the clinical site|subjects were screened for meeting medical and oral health criteria. Then completed a 1 week washout period with fluoride toothpaste prior to receiving any study treatments.
747847|NCT00761891||
747848|NCT00761865||
747849|NCT00761813||Subjects were consented and then randomized. Some subjects were enrolled but dropped prior to randomization. Or withdrew after being randomized so no data was collected
747850|NCT00761774|The study started to enroll patients in November 2008 and concluded in March 2017.|Participant Flow refers to the Safety Set, which consisted of all subjects who took at least 1 dose of study drug.
747851|NCT00761761||
747852|NCT00761748|The subjects were recruited by the investigators at multiple sites in Germany.|39 subjects were enrolled in the study, however 9 subjects were excluded from participating in the study.
747853|NCT00761735||Of 107 participants who enrolled in Part 1 of this study and were potentially eligible for the Part 2 Long Term Follow-up (LTFU), 94 participants enrolled in the current LTFU study (Part 2).
747854|NCT00761631||Participants were stratified by age group. Group 1 included participants aged greater than (>) 15 months to less than (<) 2 years. Group 2 included participants aged greater than or equal to (>=) 2 to <5 years. Group 3 included participants aged >=5 to <10 years. Group 4 included participants aged >=10 to <18 years.
747855|NCT00761605||
747856|NCT00761592||
747857|NCT00761579||
747858|NCT00761527||The total number of participants enrolled was 2980. A total of 2978 participants received at least one dose of study medication.
747859|NCT00761514|Subjects were enrolled at 10 study sites in Puerto Rico beginning in November 2006.|Not applicable. This was an open-label study. All enrolled subjects received treatment.
747860|NCT00761462|Observational study in which patients were recruited between 1999 and 2002, and followed up for 5 years (ciprofloxacin patients) or 2 years (non-ciprofloxacin patients), monitoring the occurrence of musculoskeletal and central nervous system events.|The decision to treat with ciprofloxacin or a non-quinolone antibiotic was made prior to a patient's enrollment in the study and was based on the particular infection, type of patient, medical history, and the clinical evaluation by the prescribing physician. The study was not randomized.
747861|NCT00761345||
747862|NCT00761319|Patients were recruited from 78 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for at least one month immediately prior to Visit 1 were enrolled.|705 patients were enrolled in this study. 701 patients were evaluated for safety. Baseline characteristics are presented for all patients who received test article and had at least one on-therapy visit (intent to treat): 652.
747863|NCT00761306|Patients eligible to participate in present study, NCT00761306 / 11492C, were outpatients, who had completed lead-in study NCT00839423 / 11492A immediately prior to inclusion into present study.|The study consisted of a 1-week, fixed-dose period with Vortioxetine 10 mg/day, a 51-week flexible dose period with Vortioxetine 5 or 10 mg/day, and a 4-week safety follow up period.
747864|NCT00761280||
747865|NCT00761267||
747866|NCT00761215||
747867|NCT00761202||
747868|NCT00761189||
747869|NCT00761176||
747870|NCT00761150||
747871|NCT00761137||Four interventions, subjects were randomly assigned to one of 16 sequences.
747872|NCT00761085||
747873|NCT00761007|First subject enrolled 15/07/2008, last subject observed 18/02/2009, at 60 study centres in 9 European countries (Denmark, Germany, Italy, Latvia, Russia, Slovak Republic, Spain, United Kingdom, and Ukraine.|Subjects underwent a 2-week screening period to meet inclusion/exclusion criteria and were subsequently randomised.
747874|NCT00760994|Participant who wanted to decrease their alcohol use were recruited through newspaper advertisements & flyers. One hundred thirty two individuals were consented, 92 out of the 132 consented individuals were eligible, and 80 were randomized. Seventy eight participants received an intervention.|"Out of 132 individuals who provided written consent, 40 were ineligible:
~10 individuals didn't use alcohol or have an alcohol diagnosis.
~16 individuals didn't have PTSD.
~4 individuals used an opiate or methamphetamine.
~7 individuals had a bipolar disorder or psychotic.
~3 individuals had reasons other than the ones above."
747875|NCT00760877||Participants were randomized 1:1. Participants in the imatinib arm were permitted to cross-over to nilotinib after 2 years on study if complete molecular response (CMR) was not achieved, or at any time during the study if participants experienced treatment failure, had confirmed loss of major molecular response (MMR) or had confirmed loss of CMR.
747876|NCT00760838||
747877|NCT00760747||Study Period II was a 10-week treatment period. Study Period III was a 4-week period, during which participants continued on atomoxetine treatment in the same dose as given at the end of Study Period II or in a higher dose, up to a maximum of 1.8 mg/kg/day.
747878|NCT00760669||
747879|NCT00760617||
747880|NCT00760578|The study was conducted in the United States by 10 investigators between 26 Sep 2008 and 02 Feb 2009.|This was a Ph 2A, double-blind, randomized, comparator- & placebo-controlled study of Mitoglitazone in otherwise healthy adult patients with type 2 diabetes. The study consisted of a maximum 21-day screening period, a 2 week, single-blind, placebo lead-in period, a 4 week, double-blind treatment period and a 1 week posttreatment follow-up period.
747881|NCT00760552||249 total were enrolled. 122 had controlled BP and did not participate in the trial. of the 127 who participated, 4 dropped prior to randomization.
747882|NCT00760526|Recruitment occurred between January 2009 and December 2010 at the 5 participating DirecNet clinical centers.|Prior to randomization, enrolled participants had a run-in period of 6 weeks to optimize glycemic control prior to CGM use. A blinded CGM was then used for 2-4 weeks prior to randomization to familiarize participants and parents with the device and to collect data for assessment of baseline glycemic control.
747883|NCT00760513||
747884|NCT00760487|Subjects >21 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.|Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
747885|NCT00760474||Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence.
747886|NCT00760461||
747887|NCT00760435||
747888|NCT00760383|Participants were recruited from the Slocum Center for Orthopedics and Sports Medicine.|Participants were selected from surgical candidates from the Slocum Center for Orthopedics and Sports Medicine. All subjects were scheduled to undergo primary TKA.
747889|NCT00760266||
747890|NCT00760214|Participants enrolled at 122 investigative sites in Bulgaria, Estonia, Finland, Germany, the Netherlands, Poland, Russia, Serbia and Montenegro, Slovakia and Sweden from 24 January 2008 to 21 April 2009.|Participants with essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
747891|NCT00760084||
747892|NCT00760019||
747893|NCT00760006||Protocol exclusion criteria includes children already receiving antibiotics at the time of their surgery, and will be evaluated distinctly, but will not be included in the antibiotic or placebo groups. Therefore, only participants receiving preoperative antibiotics are considered for our outcome measure.
747894|NCT00759967|22 patients were recruited from the hemodialysis (HD) units of the Ottawa Hospital. 3 patients withdrew prior to randomization. 19 patients complete the conventional arm of the study, 2 patients withdrew during the short daily HD arm - they are included in the intention to treat analysis|There was a 3 month run in phase in which blood pressure was optimized prior to randomization. The 3 patients who were not randomized - 1) withdrew consent, he did not want his blood pressure taken routinely in dialysis, 2) one patient had concerns about medications being removed during daily dialysis that could not be reconciled, 3) screen failure
747895|NCT00759954|Participants were recruited from general public. The signed consent forms were obtained during the period of September 7 - 13, 2004.|Wash out period was 7 days. No enrolled participants were excluded from the trial before assignment to groups
747896|NCT00759941|Eligible glaucoma patients were recruited and enrolled from 7 US study sites between Oct 15, 2007 and April 06, 2009.|This reporting group includes all enrolled subjects.
747897|NCT00759915||
747898|NCT00759902||
747899|NCT00759876|This extension study was initiated approximately 2 years after the completion of Study PTC124-GD-004-DMD (Study 004 [NCT00264888]).|Of the 36 participants, 11 received 20-, 20-, and 40-milligrams/kilograms (mg/kg); 20 received 10-, 10-, and 20-mg/kg; and 5 received 4-, 4-, and 8-mg/kg ataluren dose level in Study 004. The 31 participants receiving corticosteroid treatment at study entry could continue corticosteroid treatment during the study as long as regimen remained stable.
747900|NCT00759863||
747901|NCT00759811||
747902|NCT00759785||
747903|NCT00759772||
747904|NCT00759759||Wash out period of at least 7 days.
747905|NCT00759707||
747906|NCT00759681|A total of 217 subjects (110 ArterX, 107 Control) were treated at eleven (11) participating investigational centers. Randomized subjects were treated from 10/08 to 12/09. The last follow-up visit was conducted in 03/10.|
747907|NCT00759668|35 patients, diagnosed with bilateral cataracts age related, requiring extraction of cataracts in both eyes followed by implantation of a posterior chamber intraocular lens, were recruited.|Patients meeting the inclusion/exclusion criteria were enrolled.
747908|NCT00759655|The study was planned to be conducted in major hemophilia centers in North America, Latin America, and Asia-Pacific regions. Seven (7) sites were initiated; however, recruitment occurred at only 1 site in United State of America (USA) between June 2009 to December 2009. The study was terminated by the Sponsor.|
747909|NCT00759642||
747910|NCT00759603|Recruitment Period: September 22, 2008 to November 02, 2009. All recruitment done at The University of Texas MD Anderson Cancer Center.|One of the 60 participants enrolled was excluded from the trial before any treatment assignment.
747911|NCT00759577|Of the planned 100 patients to be enrolled only 36 were enrolled.|
747912|NCT00759564|This was a fixed sequence design study (not a complete 2 way crossover) in parallel groups of participants with varying degrees of renal impairment, where all subjects received the intravenous formulation in first period and then received the oral formulation in second period.|Participants were planned to receive CP-70,429 800 milligram (mg) in all reporting groups. For severe renal impairment group, CP-70,429 dose was decreased from 800 mg to 200 mg as per protocol amendment. Only 1 participant received 800 mg dose and was excluded from all descriptive and statistical analyses as per change in planned analysis.
747913|NCT00759525||
747914|NCT00759473||
747915|NCT00759408||
747916|NCT00759395|A single site, randomized, double blind, placebo-controlled, parallel group experimental study. Patients recruited between November 2008 and October 2011.|Screening for eligibility and wash-out of restricted medications.
747917|NCT00759356||Wash out period of at least 7 days.
747918|NCT00759330|The study was conducted at 10 clinical sites in the US from September 2007 to July 2008. Patients with chronic LBP below the 12th thoracic vertebra of greater than 3 months duration and with an average daily pain score of 4 or greater on an 11-point categorical pain scale for the last 3 days of the baseline phase were eligible to participate.|Prior to randomization into the Tape Treatment Phase, participants began a 14-day washout period of previously used pain medications. Participants were then randomized to 1 of 4 treatments. After 7 days of treatment, patients returned to the clinic for a study exit visit. Participants were provided with rescue medication throughout the study.
747919|NCT00759187|At clinical site|
747920|NCT00759174||
747921|NCT00759161||
747922|NCT00759148|Subjects were recruited from 108 study centers located in the US.|1179 subjects with bacterial conjunctivitis were randomized and treated to Moxifloxacin AF or Moxifloxacin AF vehicle.
747923|NCT00759109||The Intent-to-Treat (ITT) population included all randomized participants who took at least one dose of medication, and presented at least one further efficacy evaluation. No efficacy assessment post-baseline was obtained for 4 participants in the control group, therefore the ITT population included 146 (74 PegIntron + 72 Control) participants.
747924|NCT00759096|Eligible patients with bilateral cataract were implanted with ReSTOR lens and followed up for 6-month after the 2nd eye implantation|Open-label, single arm and nonrandomized
747925|NCT00759031|At clinical site|
747926|NCT00758862||
747927|NCT00758836||
747928|NCT00758784||
747929|NCT00758771||
747930|NCT00758758|Subjects were recruited between December 1999 and March 2007 from the investigators medical clinics.|
747931|NCT00758745||
747932|NCT00758706||
747933|NCT00758680||
747934|NCT00758667||
747935|NCT00758602||
747936|NCT00758589|510 patients enrolled, 368 were allocated to treatment and 350 completed the study. First patient entered the study on 16 September 2008 and the last patient finished the study on 13 July 2009.|
747937|NCT00758576|Only adult subjects of either gender in need of cataract extraction in both eyes were considered for enrollment. 64 subjects were implanted bilaterally with the ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1|Subjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.
747938|NCT00758563|At clinical site|
747939|NCT00758550|60 cataract patients were enrolled into the study|Randomized
747940|NCT00758498|4 centers in the United States (US; origination study centers) and 3 centers in France (destination study centers). First participant enrolled: September 2008 / Last participant last visit: February 2009|Study consisted of a 1 to 8 week screening period, a 3-day double blind treatment period, and a 7-day follow-up period. 1298 subjects were screened, 431 subjects met entry criteria in the US; 4 subjects were ineligible upon arrival in France (due to AEs), and 1 subject randomized to placebo did not have any post-baseline efficacy assessments.
747941|NCT00758485|Participants were recruited from 10 sites in Germany from November 2008 to May 2009.|
747942|NCT00758459||
747943|NCT00758420||
747944|NCT00758394|At clinical site|
747945|NCT00758342||
747946|NCT00758290|At clinical site|
747947|NCT00758264||3 subjects have not been contacted for the Extended Safety Follow Up phase, out of which 2 subjects have not been contacted due to lost to follow-up (1 subject in Nimenrix + Synflorix Group and 1 subject in Nimenrix Group) and 1 subject due to consent withdrawal (Synflorix Group).
747948|NCT00758160||
747949|NCT00758069|"Phase II.
~First patient in: 31 July 2005. Last patient, last visit: 13 February 2006.
~The study was conducted at 8 centers in Japan."|Patients 20-69 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and <10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.
747950|NCT00758043||
747952|NCT00757822|Recruitment period was from 12-02-2009 to 11-20-2013. Participants were recruited during pre-surgery or preanesthesia clinic visits for elective outpatient abdominal surgery lasting at least 1 hr. Inclusion criteria included high risk for post-operative nausea and vomiting (PONV) as measured by a Koivuranta score (K score) of 2 or more.|36 participants were withdrawn prior to assignment into a treatment arm: 8 participants voluntarily withdrew prior to surgery date, 2 did not meet inclusion criteria, 6 had exclusion criteria, 3 withdrawn when study was closed to enrollment, 17 were withdrawn due to cancellation or re-scheduled surgery incompatible with study schedules.
747953|NCT00757783||A total of 68 participants were enrolled in the study, and out of which 65 were treated.
747954|NCT00757705||
747955|NCT00757666||
747956|NCT00757627||
747957|NCT00757601||
747958|NCT00757588||Of 455 participants randomized, 402 received treatment and completed the 24-week phase. Two participants were mistakenly identified as not completing the short-term (ST) treatment period, although they did. The discrepancy was identified after the ST phase database lock. In reality, 404 completed the ST phase.
747959|NCT00757484||This was a chart review study. 37 participants were not analyzed because the data in their chart was not available.
747960|NCT00757237|Seventy-three sites in the United States (US) and European Union (EU) enrolled a total of 274 participants in the study.|Of the 274 participants enrolled in the study, 273 were randomized between 07 August 2008 and 12 November 2009. One subject experienced a serious adverse event (SAE) between Visits 1 and 2; this subject did not receive study drug. A total of 268 participants received study drug (136 AZLI; 132 TIS).
747961|NCT00757172|Seventy participants were recruited between January 2009 to July 2011 from 24 institutions.|Five participants were declared ineligible. One participant had a celiac lymph node >2 cm and one participant had two primary tumors. Liver lesions were noted and not investigated in one participant. Two participants had Siewert type III tumors. These five participants were excluded from all analysis except adverse events.
747962|NCT00757003|Enrollment October 2000 - November 2007. Patients presenting or transferred to Stanford University Medical Center with thoracic aortic pathology deemed prohibitively high risk for open surgical repair.|
747963|NCT00756977||
747964|NCT00756964|Patients were recruited from the Cardiovascular Surgery clinics. Written consents were obtained from all patients.|A large number of patients were screened to achieve the final participant numbers.
747965|NCT00756938||
747966|NCT00756886||
747967|NCT00756730||
747968|NCT00756717||
747969|NCT00756678||
747970|NCT00756652||In January 2015, the FDA approved a protocol amendment that limited the scope of the study to the collection of only secondary procedure and reoperation data for the MemoryGel arm participants. No data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm.
747971|NCT00756613|All alive VADT study subjects were approached for participation in the VADT-FS.|
747972|NCT00756600||There are no significant events that occur after enrollment and before randomization.
747973|NCT00756574||
747974|NCT00756561|Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle, WA, between September - December 2008. All visits were at the University of Washington, Seattle, WA.|15 screened, 3 did not meet inclusion criteria (2 for abnormal semen parameters, 1 for abnormal liver function), 1 decided not to enroll, and 1 did not complete study procedures because of study end. Data analysis was performed on the first 10 of 11 subjects completing procedures.
747975|NCT00756548||386 subjects were randomized. 15 patients did not take the preparation are were excluded from the Intent-to-treat population.
747976|NCT00756496||
747977|NCT00756470|Recruitment Period: October 9, 2008 to December 30, 2011. All recruitment done at the University of Texas MD Anderson Cancer Center.|Study terminated early due to slow enrollment and review of futility.
747978|NCT00756457|From 2007 - 2009 88 potential participants were screened from a university medical center.|
747979|NCT00756444|Men and women ≥ 18 years of age with metastatic and/or recurrent squamous cell carcinoma of the head and neck were enrolled from 21 October 2008 to 23 August 2011. This study was conducted at 15 centers in Argentina, Brazil, France, Japan, Romania, and Russia.|Patients were screened at 15 sites to determine eligibility. Using an IVRS, eligible subjects were randomized to panitumumab plus cisplatin and 5-FU or cisplatin and 5-FU alone. It was estimated that approximately 45 subjects would be needed to obtain 30 evaluable subjects. More than 45 subjects were needed and 67 total subjects were enrolled.
747980|NCT00756314|The recruitment period was between July 2008 and September 2009. All women who had an abortion in any of the five public maternities in Recife were invited to participate.|Of the 403 women invited, 310 attended the service. However 39 women were excluded because they did not agree to participate and 25 women did not fill the inclusion criteria, as for gestational trophoblastic disease, benign and malignant tumors of the uterus and uterine malformation.
747981|NCT00756275||Five individuals enrolled were found to not meet study criteria, 3 did not pass the medical screen, and 13 individuals were lost prior to being randomized.
747982|NCT00756236|Subjects were consented at the pre-surgical clinical visit if they were outpatients. Inpatients were consented while they were in the hospital. Each patient were provided with a copy of the informed consent and be given at least 12 hours to make a decision.|Group assignments were randomized by a pharmacist who also prepared the study drugs. Investigators and subjects were blinded to the group assignment.
747983|NCT00756106||
747984|NCT00756093|20 dry eye subjects|randomized, double-masked, cross-over design
747985|NCT00756002|Subjects were enrolled at 19 sites in Europe and Russia from 21 August 2007 to 28 March 2008.|"Sleep quality was assessed by postsleep questionnaires during a 21-day placebo run-in. Subjects were enrolled in Ramelteon or Placebo once-daily (QD) treatment group.
~488 subjects entered placebo Run-in Period. 229 failed randomization criteria for entry into double-blind study medication phase of the study. 259 were randomized into the study."
747986|NCT00755937|This was an observational trial/registry. Recruitment began in 2002. Subjects were drawn from community centers and some academic centers.|Not applicable for an observational trial. Subjects were not assigned to treatment, but received infliximab only if their physician had decided to treat with infliximab.
747987|NCT00755911||
747988|NCT00755846|Participants enrolled at 62 sites in Chile and the United States from 17 March 2005 to 10 June 2005.|Participants with a historical diagnosis of type 2 diabetes mellitus who were either receiving no current treatment or currently treated with diet and exercise, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin enrolled in once daily (QD) groups.
747989|NCT00755807||
747990|NCT00755755||
747991|NCT00755716||
747992|NCT00755417||541 participants were randomized (enrolled), but only 532 participants received treatment and are included as STARTED.
747993|NCT00755326|Recruitment began in April 2007 and ended June 2011.|"2-week run-in period of intermediate-dose: 4,000 mg HLXL If no serious adverse events reported after 2 weeks, the high dose (5,600 mg/day) given for 6 additional weeks.
~Placebo: 14 #0 size gelatin capsules per day, orally, for 8 weeks. Intermediate-dose placebo (2-week run-in) (10 capsules daily) Highest-dose placebo (14 capsules daily)"
747994|NCT00755274|Participants were enrolled from 15 September to 1 October 2008 in 1 clinical center in the US.|A total of 32 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
747995|NCT00755261|Only 4 subjects were accrued over 2 years. Study was closed due to slow accrual.|
747996|NCT00755235||
747997|NCT00755222||
747998|NCT00755196||
747999|NCT00755183||
748000|NCT00755131|"This study was a single-center, randomized, controlled study carried out from October 2008 to January 2009 at the Department of Clinical Medicine, Cardiovascular and Immunological Sciences, University of Naples Federico II."|
748001|NCT00755105|Participants were invited to join the study if they had participated in a study involving consumption of Iron-55 at least one year earlier at Grand Forks Human Nutrition Research Center|All enrolled participants were included
748002|NCT00755079||
748003|NCT00755040||
748004|NCT00754936|Overall flow of study participants|106 participants enrolled in the study; however, 35 exited during the 2-week washout period and did not start study medication.
748005|NCT00754923||
748006|NCT00754845||
748007|NCT00754832||
748008|NCT00754793|Recruited patients with chronic sinusitis and depression (PHQ9>=10) who were not already on an antidepressant.|No adverse events. No exclusions post enrollment.
748009|NCT00754767|oncology clinic|
748010|NCT00754741||
748011|NCT00754650||
748012|NCT00754624|First patient enrolled May 31, 2004 Multi-center international trial conducted in USA, Bulgaria, Czech Republic, and Germany. Conducted in medical offices, hospital clinics, and universities.|This was a follow-on trial for subjects who completed one of the two parent trials (PDC-IND-0008 or MKC-TI-005). Inclusion/Exclusion was participation in these parent trials.
748013|NCT00754572||
748014|NCT00754559||
748015|NCT00754546|Participants recruited from a specialty clinic in Lebanon, NH, between August 1, 2008 to May 1, 2009.|27 particpants recruited; 27 particpants screened; 5 excluded because they did not meet inclusion criteria; 2 patients withdrew consent after visit 1.
748016|NCT00754494||
748017|NCT00754468||
748018|NCT00754442|"All in the patient group were recruited from the Metabolic Bone Clinic at U Md, except one, who was recruited from prior participation in the Amish Family Osteoporosis Study, recruited from 3/15/07-11/14/08"|"Of 11 controls enrolled, 6 completed the study and 5 dropped out because they didn't want to do the parathyroid hormone (PTH) infusion. Of 9 patients recruited, 6 completed the study. The others were excluded after their screening labs showed that their renal function was below the inclusion criteria."
748019|NCT00754390|Women were recruited by the United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center to participate in an out-patient feeding study in Grand Forks, North Dakota|205 participants applied, 157 were eligible, 27 accepted invitation to attend an information meeting, 10 started study, 7 of the alternates joined study as original participants withdrew or were discharged.
748020|NCT00754377||
748021|NCT00754338|Recruitment started January 2008 at CCLR (Study completed July 2008)|Phase 1 - 38 participants enrolled, Phase 2 - 38 participants enrolled. For both Phase 1 and 2 a washout period of at least one day, during which time participants wore spectacles and no contact lenses.
748022|NCT00754325|Study started September 2008 and completed January 2014; 9 participants chose to remain on active treatment after the study completed.|100 participants were enrolled and 100 participants were randomized (50 to each arm). 99 were treated (50 with fulvestrant + dasatinib and 49 with single-agent fulvestrant). Reason for non-treatment is that there was 1 withdrawal by participant.
748023|NCT00754247|"Detailed enrollment data for participants is not available for week 4, 8, and 12.
~Reason participants did not complete study are not available for reporting."|
748024|NCT00754234|Participants recruited from the Grand Forks, North Dakota community in September 2007.|154 applied,(47 applied too late, 30 did not meet inclusion criteria and 52 refused participation) 25 screened,4 excluded (3 did not pass screen and 1 refused participation), 5 alternates
748025|NCT00754208|Recruitment occurred from September 2008 through Deceber 2009 in an academic medical center.|Please see inclusion and exclusion criteria.
748026|NCT00754156|Patients who met study criteria were enrolled from January 26, 2009 through December 6, 2010.|Study candidates were identified following index laparotomy where the abdominal cavity could not be closed primarily. Following informed consent, patients were enrolled if attempts at primary closure were unsuccessful during the second laparotomy.
748027|NCT00754130||
748028|NCT00754065|The date of first subject first visit was 08 Sep 2008. The date of last subject last visit was 10 May 2011.|A total of 776 participants were screened; 367 failed Screening, and 409 were randomized 1:1, of which 14 never received treatment, and 395 were treated (EV/DNG=191; EE/NGM=204). A total of 203 subjects (99 received EV/DNG and 104 EE/NGM) in the US and 192 (92 received EV/DNG and 100 EE/NGM) in Canada received at least one dose of the study drug.
748029|NCT00754052||
748030|NCT00754013|This study planned to recruit subjects at 26 centers in the United States. However, the study was terminated early and only 5 centers enrolled subjects during the period of 06 Oct 2008 to 10 Dec 2008.|
748137|NCT00748657|The study was activated on 9/22/2008 and closed to accrual on 1/31/2011 (suspended from 1/4/2010 to 8/9/2010).|
748031|NCT00753948|Participants were recruited from SCI service of James J. Peters VAMC as well as from SCI outpatient clinics. Participants in the asthma group were recruited through medicine clinic at James J. Peters VAMC. Healthy able-bodied controls were recruited from the group of able-bodied controls that has been doing studies with our center in the past.|
748032|NCT00753935||
748033|NCT00753922||
748034|NCT00753896||
748035|NCT00753766||
748036|NCT00753714|A total of 124 patients have been enrolled in a period of 19 months in 17 actively recruiting Oncologic Medical Department in Italy.|
748037|NCT00753688||
748038|NCT00753675|180 subjects were screened at 19 sites and 174 were randomized|
748039|NCT00753649|Study started on 23-Sep-2008 and enrolled 224 subjects from Canada.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
748040|NCT00753636||35 Screened
748041|NCT00753623|Subjects were recruited in person at the MGH Center for Pain or by advertisement throughout MGH and the local community.|
748042|NCT00753545|The first patient was enrolled on 28 August 2008 and the last patient was enrolled on 9 February 2010. Patients were enrolled at 82 centres in 16 countries. Of the 326 patients enrolled, 265 were randomized|It was planned that 250 women with advanced platinum sensitive serous ovarian cancer who had received 2 or more previous platinum-containing regimens and demonstrated an objective stable maintained response in the last platinum regimen prior to enrolment were to receive olaparib 400 mg bd or matching placebo in a 1:1 ratio. 265 randomised.
748043|NCT00753519||
748044|NCT00753506|We enrolled n=66 participants drawn from the Sheppard Pratt Health System and from rehabilitation and treatment programs in Central Maryland. Dates of recruitment 8/08-1/10.|We used a two week placebo run in for all participants
748045|NCT00753454|The study started in September 2008 with subjects from Canada and the United States. The primary completion date occurred in May 2011, with study completion in May 2011.|"Participant Flow and Baseline Characteristics refer to the Full Analysis Set (FAS). The Full Analysis Set (FAS) consists of all subjects who were dispensed medication.
~One subject was discontinued at the discretion of investigator due to missed visits."
748046|NCT00753415|V935 alone or in combination with V934 was administered to 37 participants with selected solid tumors in Part A.|Of the 37 participants who were enrolled in Part A, 32 participants completed and were eligible to enroll in the optional extension study Part B. There were 28 participants who elected to enroll in Part B.
748047|NCT00753363||
748048|NCT00753337|Recruitment was for a period of 16 months. Subjects were recruited at medical clinics who participate in clinical trials.|
748049|NCT00753298||
748050|NCT00753272|Subjects were vaccinated during the pre-influenza season at Day 0, were contacted by phone during the surveillance period from mid November to the end of the influenza season (April-May) and were contacted by phone at Days 270 and 365 for the Year 1 influenza season 2008/2009 and the Year 2 influenza season 2009/2010.|For lot-to-lot consistency analyses after Dose 1 at Day 0 of the Year 1, FluNG Group was divided in 3 sub-groups: FluNG Lot 1 Group, FluNG Lot 2 Group and FluNG Lot 3 Group: subjects received 1 dose of FluNG vaccine Lot 1, 2 or 3 at Day 0 of the Year 1. They all received Dose 2 at Day 0 of the Year 2, again from 3 different lots.
748051|NCT00753220|Men at least 18 years of age diagnosed with prostate cancer with metastases limited to three sites (e.g., lymph nodes and/or bone) who have been determined to have undergone progression of their cancer under androgen blockade (i.e., are androgen-independent) will be eligible for this study.|Prior to any screening evaluations, the purpose of the study & study related tests/procedures will be explained, then subject signs ICF. Subject will undergo screening assessments to determine if he meets all of the inclusion criteria & none of the exclusion criteria. Screen failures will not be eligible for re-screening.
748052|NCT00753142|Participant enrollment began in March 2004 and all study follow-up was completed in December 2009. The study was conducted at the Clinical Research Center at Grady Memorial Hospital in Atlanta, Georgia.|
748053|NCT00753012||
748054|NCT00752986|The study was prematurely terminated.|39 participants were randomized to receive vandetanib or placebo.
748055|NCT00752973||
748056|NCT00752908||
748057|NCT00752895||
748058|NCT00752856||
748059|NCT00752791|Participants enrolled at 26 sites in Australia, Italy, New Zealand, the United Kingdom and the United States from 31 October 2008 to 19 May 2010.|Participants with chronic renal failure on peritoneal dialysis and receiving stable Epoetin (alfa or beta) maintenance therapy were enrolled into 1 treatment group (peginesatide injection).
748060|NCT00752726|This multicentric clinical study was conducted in 2 countries; 2 centres in United States of America (USA) and 1 centre in Sweden.|Out of 267 screened participants, 131 were randomized, while 136 participants were considered as screen failures.
748061|NCT00752622||"Of the 100 enrolled participants, 2 participants experienced a protocol violation that excluded them from the Eligible (ELIG) population, thus, the ELIG population comprised of 98 participants.
~Due to early study termination, all 8 randomized participants received at least one infusion of interventional treatment, but none completed the trial."
748062|NCT00752609|Participants enrolled at 18 investigative sites in the United Kingdom, Italy, Australia, and the United States from 22 September 2008 to 24 December 2009.|Participants with a diagnosis of chronic renal failure (on hemodialysis or not on dialysis) and receiving stable Darbepoetin alfa maintenance therapy were enrolled into one treatment group (peginesatide injection).
748063|NCT00752557|The study was conducted at 10 centers in the United States of America, Belgium, and Poland.|Treatment assignments were stratified by previous osteoporosis (OP) therapy regardless of rhBMP-2/CPM treatment assignment; bisphosphonate, calcium, vitamin D were provided to all participants as background concomitant OP therapy.
748064|NCT00752232||
748065|NCT00752219||
748066|NCT00752206||
748067|NCT00752128|Start recruitment: August 28, 2008 > End recruitment: March 19, 2009|
748068|NCT00752102||
748138|NCT00748579|The recruitment period was from September 2008 to July 2009.|
748139|NCT00748566||
748140|NCT00748553||
748141|NCT00748540||
748069|NCT00752089|Participants were recruited at the clinical site.|Two to three days before the start of each treatment period participants got their teeth cleaned to remove all accessible plaque and calculus, and were provided with a fluoride free dentifrice for maintaining wash-out period and standardizing the oral conditions.
748070|NCT00751998|Between November 27, 2006 and April 4, 2008 a total of 297 subjects were enrolled.|
748071|NCT00751972|A total of 140 patients were enrolled at 30 sites into the study by giving written informed consent and were implanted with a HeartWare HVAD between August 18 2008 and February 23 2010.|This was a non randomized,open label,contemporaneously controlled trial. Pats. in the treatment arm were screened against the incl. & excl. criteria to determine eligibility to proceed to implant of the investigational device. Control Pats.contemporaneously entered into the INTERMACS (NCT00119834) database were selected using specified criteria.
748072|NCT00751933||
748073|NCT00751881|A total of 1493 participants were screened at 193 sites in 26 countries. The common end date for core treatment period was on 17 April 2012 (maximum treatment duration of 173 weeks). The extension study was completed on 18 June 2015 (maximum treatment duration was 174 weeks in addition to core treatment period).|Randomization was stratified by investigational site and Expanded Disability Status Scale (EDSS) score ≤3.5 or >3.5). Assignment to groups was done using an Interactive Voice Response System(IVRS) in 1:1:1 ratio. 1169 participants were randomized at 190 sites. 780 participants completed core treatment period and 751 were treated in extension study.
748074|NCT00751790||
748075|NCT00751777||
748076|NCT00751634||
748077|NCT00751621|Subjects who had previously participated in the pivotal study ZLB06_001CR (NCT00542997) were enrolled in the extension study ZLB07_002CR.|
748078|NCT00751530||
748079|NCT00751400|Recruitment for the study was conducted using newspaper ads, direct mailing, in-store pharmacy posters, and flyers. Potential subjects who learned about the study through local advertising were directed to call a toll-free number (call center at the CRO (Contract Research Organization)) where minimal screening questions were asked.|Once at the pharmacy, if the screening criteria were met, subjects were given an (empty) OTC (Over The Counter) package and were allowed as much time as needed to review the label. They were then told the cost of the investigational product and asked if they would like to purchase it for their own use.
748080|NCT00751348|Out of 475 subjects enrolled in the study, one did not receive any vaccination.|During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
748081|NCT00751335|All data from this trial has been lost This includes all case report forms and consent forms and therefore, there are no results to report as no data exists|
748082|NCT00751296|This was a single site, Investigator initiated study. Patients gave informed consent according to institutional and university human experimentation committee requirements. Previously untreated B-cell CLL patients >/= 18 years of age were eligible if they met the eligibility criteria.|Study was halted and the protocol amended after severe toxicities were noted in the first 2 study patients when they were dosed as per the initial protocol dosing guidelines. Their data was not included in the analysis and additional 25 eligible patients were enrolled and their data was analyzed.
748083|NCT00751179||
748084|NCT00751140|Sample: Up to 30 patients with a diagnosis of urothelial carcinoma of the upper urinary tract in the absence of pre-operative (radiographic) lymphadenopathy or other areas of suspected metastatic disease were planned to serve as the investigators' study sample population.|
748085|NCT00751114|EASIE was a multicenter, international, randomized, open-label trial conducted from November 12, 2008 to July 28, 2011.|A total of 732 patients were screened in 96 centers in 17 countries. The study included an initial 2-week screening period. A total of 217 patients were screen failures. The main reason for screen failure was Glycosylated Hemoglobin A1c (HbA1c) inclusion criterion not met (146 patients).
748086|NCT00751101||
748087|NCT00751036||
748088|NCT00751023||The Enrollment number in the Protocol Section has been corrected (n=40) to appropriately match the number of participants listed in the Results Participant Flow section. The previous Protocol section incorrectly included a cohort (n=31) of healthy control subjects who underwent cognitive testing but did not participate in the modafinil trial.
748089|NCT00750919|Participants who completed P05701 (Base study NCT00631657) were eligible to enroll on P05721 (Extension study).|
748090|NCT00750893|This post marketing study (PMS) covered a period of 6 consecutive years. Results were presented for Years 1, 2, 3, 4, 5 (Year [Y] 1 & Y2 data combined and presented at the Y2 time point and Y3 & Y4 data combined and presented at the Y4 time point) along with consolidated surveillance data from Y1- Y6 timepoint.|Consolidated participant flow and baseline measure data were given for Years 1 to 6 time point in order to account for all the subjects participating in this study.
748091|NCT00750880||
748092|NCT00750867||
748093|NCT00750815|Participants were recruited at Moffitt Cancer Center from September 2008 to August 2011.|
748094|NCT00750737|Recruitment Period: July 2008 to May 2009. All recruitment done at UT MD Anderson Cancer Center.|A total of 46 participants were randomized, out of which 40 participants were included in the analysis and 6 participants withdrew consent.
748095|NCT00750555||After the enrollment of 4 participants in this study, the PI left Geisinger. Geisinger does not have any details regarding which Arm/Group participants were assigned to.
748096|NCT00750438||Non fermentable arm not conducted
748097|NCT00750373|Patients were eligible for enrollment if they were diagnosed as definite infective endocarditis and had both severe mitral or aortic valve disease and vegetation length > 10 mm. Between September 2006 and March 2011, a total of 76 patients were enrolled at the Asan Medical Center (n=71) and Seoul National University Hospital (n=5) in Korea.|The exclusion criteria were defined as patients with moderate to severe CHF; heart block; annular or aortic abscess; fungal endocarditis; and those who were not candidates for early surgery on the basis of age > 80 years, coexisting major embolic stroke with a risk of hemorrhagic transformation and/or poor medical status.
748098|NCT00750360||
748099|NCT00750308||
748142|NCT00748410|A total of 3 participants were enrolled and randomized from 22 January 2009 to 12 December 2009. This study was conducted at Academic Medical Centre, Amsterdam, The Netherlands. The study was early terminated on 17 February 2010.|
748100|NCT00750282|"There were two parts in this study, Part A and Part B. Part A was conducted in Australia, Germany, Switzerland and USA. Subjects were recruited from 17 centers. HVs were age matched to subjects with probable Alzheimer's (AD).
~Part B was conducted in Australia, Germany, Japan, Switzerland, and USA, subjects recruited from 22 centers."|"Part A screened 214 subjects; 113 AD and 101 HV. There were 63 screen failures (40 for inclusion criteria, 14 withdrew consent, 9 for other reasons) and one dropout prior to receiving study drug.
~Part B screened 392 subjects; 204 AD and 188 HV. There were 118 screen failures for similar reasons and 2 dropouts prior to receiving study drug."
748101|NCT00750269|This study was designed to start at dose level 5. Dose levels 1-4 were in place only to be used if the regimen in general proved too toxic and lower dose levels were needed. No patients were accrued to levels 1-4.|
748102|NCT00750204|2 participants were enrolled|
748103|NCT00750191||Among the 32 treatment subjects, 4 were removed from the study due to violation of eligibility criteria and 1 removed for withdrawing patient consent. Among the 32 sham subjects, 2 patients were removed from the study due to violation of eligibility criteria.
748104|NCT00750165||
748105|NCT00750152||
748106|NCT00750139||
748107|NCT00750061||
748108|NCT00749996||"A total of 7 patients were enrolled but not randomized:
~6 were excluded due to eligibility criteria not met, and 1 was excluded due to non-compliance issue."
748109|NCT00749957|Twelve subjects with DNA sequence-confirmed mutations in RPE65 were enrolled, 10 at the Casey Eye Institute and 2 at the University of Massachusetts, between June 2009 and September 2012.|
748110|NCT00749944||857 participants were screened; 110 participants met the criteria for inclusion into the study and were assigned to study treatment
748111|NCT00749931||
748112|NCT00749892|Recruitment began 6/9/2008 and concluded on 12/19/2011 in the medical clinic. Diagnosis of invasive transitional cell carcinoma in the bladder, upper tract or urethra tumors were required for participants who were candidates for cystectomy to be considered. Participants with high-risk features were generally excluded.|Erlotinib treatment milestone: Three participants decided to not start the study medication.
748113|NCT00749879|Of the 17 participants, 4 did not meet inclusion/exclusion criteria, and 1 participant enrolled as a spare was not needed, resulting in their involvement in the study being terminated. The remaining 12 participants completed all five study treatments of Proellex.|"Each of the 12 participants were randomly assigned a unique sequence of the following 5 following open-label treatments of Proellex
~25 mg formulated with AMCC (fed state)
~25 mg formulated with AMCC (fasting state)
~50 mg formulated with AMCC (fed state)
~50 mg formulated with AMCC (fasting state)
~50 mg formulated with SMCC (fasting state)"
748114|NCT00749775||
748115|NCT00749749||
748116|NCT00749684|Male and female participants, with malignant melanoma Stage II or III (>1.5 mm tumor thickness, no distant metastasis) or malignant melanoma with evidence of lymph node metastis or lymph node metastasis of malignant melanoma at unknown primary tumor, primary tumor has to be surgically resected within 2 months after first biopsy/excision.|
748117|NCT00749671||
748118|NCT00749658||
748119|NCT00749606|Enrollment took place from June 22, 2009 - Oct 2, 2010 from 5 diverse primary care practice sites in upstate NY: Oneida Healthcare Center (small city), Pulaski Health Center (rural), Syracuse Community Healthcare Center and University Health Care Center (urban, poor, medium city), and University Internists (higher income, medium city).|
748120|NCT00749580|Participants were recruited from the HIllsborough County Health Department, and Tampa Care Clinic, Tampa, Florida.|Per the inclusion and exclusion criteria
748121|NCT00749515|Between March 2008 and June 2008, 15 patients were recruited who had transfusional iron overload, and had been on deferasirox for at least 6 months at some point in their chelation history. Ten (10) patients were recruited as inadequate responders and 5 were recruited as control patients with adequate response to deferasirox therapy.|
748122|NCT00749476|Patients were recruited in France from May 2008 to January 2009.|Before enrollment there was up to a 14 day screening period and the investigator reviewed the subject's medical history and medications to ensure that the subject was in good health and met all of the inclusion criteria and none of the exclusion criteria.
748123|NCT00749463||
748124|NCT00749411|This study was conducted between 13 November 2008 and 12 February 2009, at 12 centers in the United States.|A total of 127 participants were screened out of which 61 participants were enrolled and randomized to receive at least one dose of study medication in the study.
748125|NCT00749398||
748126|NCT00749268|Between November 4, 2008 and November 4, 2010, 117 subjects signed informed consent for the inguinal hernia arm of the study and 113 for the ventral arm. Of those subjects who consented, 106 and 110 were randomized to a treatment group (either AbsorbaTack™ or ProTack™) for inguinal and ventral hernia repair, respectively.|
748127|NCT00749203|Patients with chronic PTSD related to a range of trauma exposures were recruited via advertisements beginning Jan 2009, and were enrolled at the Icahn School of Medicine at Mount Sinai, New York, between May 2009 and December 2012.|
748128|NCT00749190||
748129|NCT00749125|2004-2009. Participants from Washington University in St. Louis.|99 participants started the study and were assigned to either the depressed or control group.
748130|NCT00749073|Study enrolled between September 2008 and January 2009. Recruitment derived from patient pool of complex cases, all with confirmed presence of hypertrophic ligament, wait-listed for decompression laminectomy.|
748131|NCT00748982|The study enrolled 33 patients and randomised 16 patients between August 2008 and July 2009 at a Clinical Pharmacology Unit located at a University Hospital in Sweden.|Screening for eligibility and no significant changes in the medication for heart failure during the preceding 1 month before enrolment. In addition, patients for whom it was not possible to obtain high quality echocardiographic pictures were excluded from the study. The pre-entry visit was 30 days or less before the first dosing visit.
748132|NCT00748969||
748133|NCT00748956||
748134|NCT00748865|20 dry eye subjects|Randomized, double-masked, cross-over design
748135|NCT00748826||508 rheumatoid arthritis participants initially enrolled on study. An additional 68 participants with psoriatic arthritis (PsA) were enrolled but were not included in the analyses.
748143|NCT00748241||
748144|NCT00748215|Recruitment Period: February 04, 2009 to May 3, 2012. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.|Of the original 100 patients enrolled and randomized to the 6 week intervention period, 39 patients would go on to take open label CASAD; 22 patients from the CASAD arm and 17 patients from the placebo arm. These patients were added as a Milestone on the Participant Flow sheet. 8 patients received open label for <21 days; 31 patients received open label CASAD for >21 days.
748145|NCT00748189||Eligible participants (par.) were stratified by age (<65 years vs. >=65years), stage (Binet A vs. B vs. C) and Eastern Cooperative Oncology Group (ECOG) performance status (0-1 vs. 2). Participants in each stratum were then centrally randomized in a 1:1 ratio to receive ofatumumab plus chlorambucil (O+CHL) or chlorambucil alone (CHL).
748146|NCT00748098||
748147|NCT00748085||
748148|NCT00748072|We enrolled all patients with serum creatinine less than 1.5 mg/dL and/or estimated glomerular filtration rate greater than 60 mL/min/1.73m2 and normal coagulation parameters, undergoing ultrasound-guided biopsy of native kidney, in our Unit, from August 2008 to December 2009.|The exclusion criteria were solitary kidney, kidney cancer, hydro/pyonephrosis, significantly reduced renal size at ultrasound image, severe obesity (body mass index > 30), chronic kidney disease and acute kidney injury.
748149|NCT00747916||
748150|NCT00747812||
748151|NCT00747747|Period of recruitment: Nov 2007 - Mar 2009 Location: Outpatients attending medical visits by General Practitioners|
748152|NCT00747643|To achieve a sample size of 100 following attrition, we screened 573 smokers from the community and randomized 100 non-treatment seeking daily smokers to the two conditions. Smokers who were using other smoking cessation medications, or who had current mood or psychotic disorders were excluded.|Participants completed a baseline evaluation including screening for inclusion and exclusion criteria, a medical evaluation, basic metabolic panel and pregnancy test for females. Participants who met all of the inclusion criteria were scheduled for the assessment sessions.
748153|NCT00747617|Subjects recruited from UCSD clinics and coal advertising beginning in 2009 and ending in 2010|Subjects involved women with PCOS and normal control women undergoing hCG stimulation
748154|NCT00747565|Multifocal and monofocal control subjects were enrolled in the original study in 2004-2005 from the normal cataract populations at 13 USA sites. In the expansion study, additional multifocal subjects were enrolled from the normal cataract populations at 16 USA sites (13 who also participated in the original study) in 2007.|Subjects chose which type of lens to receive (multifocal or monofocal) in the original study. Subjects only received the multifocal lens in the expansion study.
748155|NCT00747552|From Jan 2006 to Apr 2008, 32 infants who were inpatients in NICU were enrolled into the study.|2 of the infants that were enrolled had the urinary catheter removed prior to any data collection. As the presence of a urinary catheter is necessary for bladder measurements, no data was able to be collected and therefore never actually started in the study.
748156|NCT00747474|The study recruitment period was from Sep 2008 to Dec 2010. Patients were recruited from three US clinical sites and one Taiwan site.|Patients will attend the clinic for a screening visit up to 28 days before receiving, if eligible, the first dose of Lipotecan®.
748157|NCT00747461||
748158|NCT00747435||
748159|NCT00747344||
748160|NCT00747227|250 subjects from normal cataract populations who were undergoing primary phacoemulsification with lens implantation and did not have any other visually significant ocular pathologies were selected at 12 investigation sites across the country|
748161|NCT00747214||
748162|NCT00747149|A total of 1044 patients (adult male and non-pregnant females) were enrolled at 122 Canadian family practice sites between May 2008 and May 2009. Out of these, only 598 patients were allocated to treatment. The remaining 446 did not receive treatment as they did not fulfill the inclusion/exclusion criteria.|Following enrolment, at Visit 1 the patients' Low Density Lipoprotein Cholesterol (LDL-C) value was baselined. If LDL-C value from Visit 1 was > 2.00, but ≤ 2.50 mmol/L: patients received Rosuvastatin (RSV)10 mg under the RSV 10 mg arm. If LDL-C value from Visit 1 was > 2.50 mmol/L: patients received Rosuvastatin 20 mg under the RSV 20 mg arm.
748163|NCT00747006||
748164|NCT00746954|Patients were recruited from the VA.|"The HF population has psychiatric co-morbidity and often is empirically treated with antidepressants.
~We screened >1000 records but enrolled and completed 8 patients, before running out of resources."
748165|NCT00746941|Twelve sites enrolled participants prior to study termination.|Participants were initially randomized in a 1:1 ratio to the local standard of care arm (represented below as 3 treatment arms depending on Week 4 and Week 8 decisions) or the local standard of care plus mefloquine 250 mg arm.
748166|NCT00746889|Patients were recruited in rheumatology clinics at UCSD and the VA musculoskeletal clinic.|Patients taking oral corticosteroids, who had a primary inflammatory connective tissue disease, or who received IA corticosteroids in the affected knee within three months of study entry were excluded from the study.
748167|NCT00746863|From January 2008 to September of 2009, all female patients planning to undergo a sling with or without an anterior or posterior repair at the University of North Carolina (UNC) Hospital were approached for participation.|
748168|NCT00746798|Participants were enrolled from 03 October 2008 to 08 December 2008 in 15 clinical centers in the US.|A total of 498 of the 479 randomized participants who met the inclusion and exclusion criteria were vaccinated. 1 subject was withdrawn from the study before receiving any study vaccine and was excluded from analysis and this report.
748169|NCT00746785|A double-blind, placebo-controlled 3 (Medication: olanzapine 5 mg, olanzapine 2.5 mg, vs. placebo) x 10 (Time: Baseline, 1, 2, 4, 6, 8, 10, 12, 24, 36 weeks). Subjects will be randomly assigned to receive either olanzapine (5 mg), olanzapine (2.5 mg), or placebo for a period of 12 weeks.|There is a discrepancy between number of participants enrolled, and number of participants started, due to some participants' ineligibility at screening. Therefore, the number enrolled refers to those participants who signed a consent form, whereas, the number started refers to those participants who were randomized to a treatment condition.
748170|NCT00746733||Open-label, randomized, four period crossover
748171|NCT00746694||
748172|NCT00746668||
748173|NCT00746590||
748174|NCT00746564||
748435|NCT00733421|All patient recruited and analysed between october 2008 and june 2009|Two patients were excluded after randomization forgot study medication and questionnaire leaving the hospital
748175|NCT00746551|This trial was conducted at Maternal Fetal Medicine Unit, Siriraj Hospital between September 2008 and December 2009. Singleton pregnant women aged 18-45 years old at GA of 32 weeks with Hb level < 11.0 g/dL, serum ferritin levels < 15 µg/L and CRP of < 20 mg/L with negative stool examination for parasitic infection were recruited into the study.|
748176|NCT00746512||
748177|NCT00746421|Recruitment period continued until April 2012 and occurred in medical clinics and through advertisements.|There was a run-in period to ensure mood stability before randomization. Some patients were lost to follow up during this period.
748178|NCT00746395|Participants recruited from a specialty clinic in Mobile, AL, USA between April 2008 and September 2008.|45 participants recruited and screened, 1 excluded, 4 withdrew from study.
748179|NCT00746356|Recruitment began in August 2008 at hospitals where patients were being implanted with implantable cardioverter defibrillators or in and physician offices where these patients were being followed. Recruitment was completed on April 1, 2009.|All patients who were enrolled in the study had the autocapture feature tested at each study visit, starting with at the implant visit when the study device was implanted.
748180|NCT00746330||
748181|NCT00746252||"Two participants enrolled and completed baseline assessments but were withdrawn from the study at baseline due to the following reasons:
~Abnormal glucose tolerance test requiring further assessment with endocrinology.
~Unable to complete lab work due to increased distress."
748182|NCT00746239|11 subjects total were enrolled in the study. It was a double blind study, however, the blind was never opened as the study was terminated prematurely due to lack of continued funding. Thus, subjects in each arm are not known. Out of the 11 subjects enrolled, 6 withdrew from the study and 5 completed the study.|
748183|NCT00746187||
748184|NCT00746122|Recruitment from 1st September 2009 to 31st July 2013. After 600 recruitment target 13 more patients were randomised before sites could be closed down.|Exclusions: persons younger than 50 years, prior AAA repair
748185|NCT00746096|This study was conducted between September 2008 and August 2009, involving 115 patients with primary dysmenorrhea at 13 center of Japan.|
748186|NCT00746018||
748187|NCT00745940|Participants were sought from local sources including: outpatient programs/clinics for individuals with neurological injury, newspaper and television advertisements, a brain injury association, social events related to treatment of brain injury, as well as through appeals to family physicians, psychologists, chiropractors and nurse practitioners.|
748188|NCT00745901||
748189|NCT00745875|80 patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) where the histology was not predominantly of squamous type were recruited between 12th August 2008 and 3rd June 2009.|14 of the 80 enrolled patients were not randomised to treatments groups: 7 patients did not meet one or more of the study inclusion or exclusion criteria, 3 patients failed screening, 2 patients were not included due to investigator decision, 1 patient withdrew consent and 1 patient died.
748190|NCT00745849|Patients were recruited from UT Southwestern outpatient clinics as well as through flyers and local advertising|43 patients were assigned for randomization after meeting inclusion criteria: age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English
748191|NCT00745823||
748192|NCT00745615|This study is LAQ/5063 (i.e., double-blind extension) and LAQ/5063OL (i.e., subsequent open-label extension). Participants who completed double-blind core study LAQ/5062 (NCT00349193) and agreed to continue in active extension study were enrolled in this study.|Double-blind extension: Participants treated with placebo in LAQ/5062 study were equally randomized to one of 2 groups: Laquinimod 0.6 mg or Laquinimod 0.3 mg. Participants previously treated with laquinimod 0.6 mg or laquinimod 0.3 mg continued on their original treatment. Open-label extension: All participants received laquinimod 0.6 mg.
748193|NCT00745498|Consecutive diabetic patients requiring pars plana vitrectomy (PPV) for complications of diabetic retinopathy at Seoul National University Bundang Hospital were referred to assess eligibility.|If indications for PPV included proliferative diabetic retinopathy (PDR) related complications such as nonclearing vitreous hemorrhage (VH), macula-involving or -threatening tractional retinal detachment (TRD) or fibrovascular proliferation with vitreoretinal adhesions, the patient was enrolled in the study.
748194|NCT00745420|Participants were enrolled between August 2008 and April 2014 from 19 different transplant centers.|
748195|NCT00745368||
748196|NCT00745290||
748197|NCT00745251|Subject recruitment occurred in 1 investigative site in the U.S. between August 2008 to February 2009|
748198|NCT00745121|A total of 103 participants were enrolled in the study (provided written informed consent).|"55 of the enrolled participants became screening failures and were excluded from the study before implant installation.
~The baseline population consist of all participants that had at least one implant installed, a total of 48 participants."
748199|NCT00745095||
748200|NCT00745030||
748201|NCT00744991||This study had 2 stages. Stage 2 would occur if the minimum level of efficacy (confirmed complete or partial anti-tumor response) was observed in Stage 1. The study was considered complete at the end of Stage 1.
748202|NCT00744978||Each participant was to complete a 3-week placebo run-in period then receive a treatment sequence of either varenicline followed by placebo, or placebo followed by varenicline, separated by a 3-week placebo washout period. Of 92 participants screened, 66 participants were randomized to treatment.
748203|NCT00744965||
748204|NCT00744939|The first participant's first visit was on 21 Nov 2008. Nineteen study centers in the United States screened and enrolled participants scheduled to undergo contrast enhanced magnetic resonance imaging (CE-MRI) with Magnevist within the approved indications at the recommended dose of 0.1 mmol/kg body weight.|A total of 168 participants were enrolled.
748205|NCT00744874||
748206|NCT00744848||
748207|NCT00744796|Twenty one patients from UT Southwestern Medical Center's Ophthalmology clinic were included.|
748208|NCT00744757||
748209|NCT00744692||
748210|NCT00744653|recruitment period: October 2008 to November 2010. Total of 17 patients included and treated with electrochemotherapy.|
748436|NCT00733408||
749352|NCT00690482|118 patients were allocated to treatment and 111 completed the study. First patient entered the study on 26 May 2008 and the last patient finished the study on 17 December 2008.|
748211|NCT00744627|Participants took part in the study at 47 investigative sites in Europe from 23 September 2008 to 07 July 2009.|Participants with a diagnosis of generalized anxiety disorder were enrolled equally in one of two treatment groups, once a day placebo or 5 mg vortioxetine.
748212|NCT00744523|The trial was approved to enroll subjects from a maximum of 25 (combined United States [US] and European Union [EU]) medical institutions (public and academic research center hospitals). Subjects were enrolled from September 2007 to February 2009.|
748213|NCT00744497||1930 participants enrolled, 1522 randomized to a treatment group (762 dasatinib, 760 placebo). 408 not randomized. Reasons for non-randomization include 7 adverse events, 42 withdrew consent, 6 deaths, 2 lost to follow up, 3 poor/non compliance, 332 no longer met study criteria, 1 administrative reason by sponsor, and 15 non-specified reasons.
748214|NCT00744380||
748215|NCT00744328||
748216|NCT00744263|Of 84496 participants who were randomized in this study, 2011 participants were included in the immunogenicity subset. Participants in the immunogenicity subset were analyzed for local reactions and systemic events as per planned analysis.|
748217|NCT00744237|Recruitment occured from September 2008 through December 2009 at 69 US sites|Placebo washout phase was required for patients currently on any anti-hypertensives at screening exclusive of background ACE inhibitor or ARB before assignment to HCTZ or Metoprolol ER or Nebivolol arms.
748218|NCT00744211|Prospective randomization in a blinded fashion, at the time of elective coronary revascularization or valve replacement requiring cardiopulmonary bypass.|
748219|NCT00744055||"Randomization was conducted by the pharmacy using a 1:1 randomization in blocks of 4 and stratified by site, gender.
~Completers were defined as subjects for whom we had complete data at the end of the treatment period (week 12) whether they remained on medication or not."
748220|NCT00744042|The trial was posted on clinicaltrials.gov. Physicians managing the care of infants and young children with a confirmed diagnosis of HPP contacted existing sites or requested assistance with site set up from the sponsor.|All screened patients met eligibility criteria and were enrolled in the study.
748221|NCT00743730||
748222|NCT00743717|Recruited during pre-op TKA clinical exam during year 2004.|
748223|NCT00743652|Blood sample was optional for subjects living in the Bethel area. Active vaccination stopped when 13-valent pneumococcal conjugate vaccine (13vPnC) was commercially available in Alaska. Study ended after a 6-month follow-up for safety following the last vaccination.|
748224|NCT00743574|Subjects recruited through flyers, medical clinics, internet postings May 2008-February 2010|Some subjects did not follow through with eligibility testing or had further exclusions, such as scheduling difficulties.
748225|NCT00743509|"Participants came in to the University of Michigan Health System outpatient Hematology/Oncology clinic and were consented to participate in this research project after a description of the research was presented by their physician.
~Forty-nine eligible patients were enrolled from September 2008 to December 2009."|Eligible participants previously treated with chemotherapy underwent screening. Fifty-one patients were consented, 49 enrolled.
748226|NCT00743483||
748227|NCT00743444|42 patients in 2 countries were enrolled in the study. 27 patients were randomised to treatment. 2 patients discontinued prematurely, 1 due to low Lower Esophageal Sphincter Pressure (LESP)/catheter placement problems, and 1 due to nausea/vomiting. Thus, 25 patients completed the study, 10 in Belgium and 15 in the Netherlands.|
748228|NCT00743431||
748229|NCT00743366||14 volunteers completed the study (12 males; 2 females). An additional 6 volunteers enrolled (5 males, 1 female), but did not complete.
748230|NCT00743340|Participants were enrolled at 2 study sites in South Africa. The first participant was screened on 22 November 2005. The last study visit occurred on 13 February 2017.|59 participants were screened.
748231|NCT00743288|This is a multicenter study|
748232|NCT00743275|Participants were enrolled from 26 August to 03 September 2008 at one US clinical center.|A total of 122 participants who met the inclusion and exclusion criteria were enrolled. Of these, 120 participants were vaccinated.
748233|NCT00743262||
748234|NCT00743249|Subjects were recruited from four US study centers.|
748235|NCT00743197||
748236|NCT00743145||
748237|NCT00743119||Thirty-four participants were enrolled, and 30 completed. A total of 30 participants completed all 5 treatment combinations in randomized order.
748238|NCT00743106||
748239|NCT00743093|Recruitment took place from August 2008 through August 2011 in the Denver Metro area. Healthy volunteers were recruited from the community through the use of approved advertisements.|398 subjects were consented for the study. Of these, 122 were excluded for not meeting full eligibility criteria. 276 eligible subjects were assigned to treatment groups, of which 252 completed all study requirements.
748240|NCT00742963||
748241|NCT00742924||
748242|NCT00742885||
748243|NCT00742872||
748244|NCT00742859|Between 31 October 2008 and 05 November 2009, 508 patients were enrolled by 35 study centers in 3 countries (USA, Canada, Germany). Patients were randomized to 1 of 4 treatment groups (1:1:1:1 allocation). The study was open-label for warfarin, while the 3 daily doses of betrixaban (40, 60, or 80 mg) were double-blinded.|561 patients were screened for study participation. Of these patients, 508 were randomized, all of whom received at least 1 dose of study drug.
748245|NCT00742781|Patients were recruited form the Pennsylvania State University University Park area and Hershey College of Medicine. The University General Clinical Research Centers on the two campuses were utilized. Recruitment was from 5/2009 to 7/2011.|The study was an open label feasibility study that used patients as their own controls. All patients were accepted into the study as long as they met the eligibility requirements.
748246|NCT00742625|Between September 2008 and February 2010, 98 participants were recruited at 15 CALGB member institutions and their affiliated hospitals.|Three (3) participants did not begin treatment and were excluded from all analyses per study design
748247|NCT00742573||
748248|NCT00742560||A total of 101 participants were randomized (intent-to-treat [ITT] population); 1 subject did not receive study drug and is excluded from the analyses.
748437|NCT00733369|2 sites enrolled 106 knees in 98 subjects who were then randomized into 2 groups, 50 into the PFC Sigma RP-F group and 56 into the PFC Sigma RP group.|Study protocol was designed and executed on using 'knees' as study units.
748249|NCT00742508||Participants randomized to receive SK&F-105517-D underwent 2 weeks of observation, 8 weeks of Primary Evaluation, 4 weeks of Exploratory Evaluation, 2 weeks of dose-tapering, and 1 week of Follow-up period. Participants randomized to receive CRV-IR underwent 2 weeks of observation, 8 weeks of Primary Evaluation, and 1 week of Follow-up.
748250|NCT00742469||
748251|NCT00742417||
748252|NCT00742391|The study period was 05 September 2008 (first patient randomized) to 23 February 2009 (last patient completed Day 57)|
748253|NCT00742326||
748254|NCT00742313|Subjects were recruited from Duke Hospital identified as undergoing endovein harvest of their saphenous vein.|Once subjects were enrolled,randomization occurred on the day of surgery. Only subject who's surgery did not occur as scheduled may have been screen failed.
748255|NCT00742274||
748256|NCT00742235|Healthy subjects were recruited via flyer to a clinical research center.|Subjects were excluded for eGFR<60, hypercalcemia, history of nephrolithiasis.
748257|NCT00742209||There were 3 subjects who were randomized but did not take investigational product, and, therefore, were not included in the Safety, Intent to Treat (ITT), or Per Protocol (PP) population.
748258|NCT00742183|Investigation period: Sept 2008 - Sept 2009. In- and/or out-patients at ten centers in US were included in this investigation. Subjects included were 5 years and above and suffered from partial thickness burns.|
748259|NCT00742170||
748260|NCT00742079|Participants were recruited from an urban community mental health center in Boston, MA from September 2006 to May 2010.|31 participants were screened, 10 were excluded (7 did not meet inclusion criteria and 2 refused to participate, 1 excluded for reasons not listed in study publication)
748261|NCT00742053|The study was conducted at the University of Utah between August 2008 and December 2008.|
748262|NCT00742001||
748263|NCT00741988||
748264|NCT00741936|All constipated patients (aged 18-65 years) who presented to the Chinese medicine clinics of the School of Chinese Medicine, Hong Kong Baptist University were referred. In total, 456 patients with constipation were screened from July 2008 to September 2009; of these 120 were randomized into MZRW or placebo group.|Many patients were excluded because they did not fulfill the inclusion criteria or they met the exclusion criteria. The demographic data and baseline variables of participants were comparable among groups
748265|NCT00741858||
748266|NCT00741819|Recruitment began 09-Dec-2008 and ended 09-Mar-2010. All recruitment took place in medical clinic settings.|Not applicable given this was an open-label study.
748267|NCT00741611|Between July 2008 and November 2009, 44 patients were enrolled into the study. The study Sponsor made a business decision in late November 2009 to terminate the trial early; enrollment was closed at that time.|Of the 44 enrolled patients, a total of 36 patients were treated. Treated patients were followed for 12 months.
748268|NCT00741598|The study procedures were conducted between January 2009 and June 2015 at two sites: the Mood and Anxiety Disorders Program at Icahn School of Medicine at Mount Sinai and the Bipolar Clinical Research Program at the Massachusetts General Hospital.|
748269|NCT00741468||
748270|NCT00741455||
748271|NCT00741390|A total of 250 subjects were enrolled in this study between 8/4/2008 (first subject visit) and 9/5/2008 (last subject visit) at two study centers.|After enrollment, baseline characteristics such as demography, diabetes history, and current lancets were recorded for each subject. No additional baseline measures were taken. Thereafter, subjects were assigned to one of the 4 intervention arms. Subjects were able to complete the enrollment visit and Study Visit 1 activities on the first day.
748272|NCT00741338|The study was conducted at 2 centers in Brazil and Russia between September 2008 and September 2013.|A total of 7 participants were enrolled, 3 in Cohort 1 and 4 in Cohort 2. Of the 4 participants enrolled in Cohort 2, one participant was screen failure.
748273|NCT00741286|ECLIPse was designed as a multicenter, randomized, double-blind, placebo-controlled trial. Between November 2006 and October 2008, 203 patients were consecutively enrolled from eight tertiary-care hospitals.|A total of 513 patients who had experienced their first classic lacunar syndromes were screened for study enrollment, of which 101 (19.7% of the screened population) refused to participate in the study. Seventy-four patients (14.4%) were not eligible for the trial, and 135 (26.3%) were excluded by the exclusion criteria.
748274|NCT00741273||
748275|NCT00741260||
748276|NCT00741156||
748277|NCT00741104|Information about patients' doctor visits prior to this study were obtained from the Swedish Rheumatology Register and the South Swedish Arthritis Treatment Group.|RA patients in Sweden normally see their doctor every 6 months. Information obtained from these visits are entered into national registries. Data in this study were based on retrospective review of the two visits preceding the study visit and the visit when infliximab was prescribed for the 1st time, as well as the one and only study visit.
748278|NCT00741091|Enrollment began on 17 December 2008. Enrollment was completed on 28 September 2010.|
748279|NCT00741039||
748280|NCT00741026|A total of 42 individuals were screened between July 2008 and June 2009, and of those individuals 15 subjects were eligible based on inclusion/exclusion criteria.|Only individuals that met inclusion/exclusion criteria were allowed to participate in the study. Of the 42 individuals screened, only 15 met criteria and were interested in taking part in the study. There was a minimum 2 week washout period in between treatment arms (i.e. placebo vs active compound).
748281|NCT00741013||
748282|NCT00740870||
748283|NCT00740857|Patients were recruited in the United States from August 2008 to October 2008.|During the screening period, the Investigator or his/her designee examined each subject and completed a checklist of the inclusion/exclusion criteria in order to determine the patient's eligibility. Surgery occurred within 14 days of the screening visit.
748284|NCT00740831||
748285|NCT00740792||
748286|NCT00740779||
748287|NCT00740727|Recruitment occurred in January 2009|A total of 20 subjects were consented. The study day ran long, so 2 subjects who had consented (and had an initial intravenous {IV} access placed, but no EASI access placed) declined to have any of the study procedures performed since the 2-hour phlebotomy window would have kept them at the study site until the evening.
748535|NCT00729157||
748536|NCT00729053||
748537|NCT00728988||
748288|NCT00740714|The recruitment period for the required 600 patients was from January 2009 to October 2010. There were 67 sites (60 in the US and 7 in Canada) that participated in the study. Most of these sites were located at or affiliated with large academic medical centers.|Patients were required to undergo a thorough screening visit. If patients were taking CoEnzyme Q10 but otherwise eligible for assignment, they were asked to return after a wash out period of 60 to 120 days based on daily dosage.
748289|NCT00740636||
748290|NCT00740597||
748291|NCT00740584|12 women recruited. Details to be provided in publication, which is in process.|Open label study, no assignment.
748292|NCT00740480|Chart reviews and patient contact in clinic. Recruitment period from July 2008 to January 2009.|
748293|NCT00740376||
748294|NCT00740220||
748295|NCT00740207|The first patient to participate in this study was dosed on September 17, 2008; the last patient on June 15, 2009.|
748296|NCT00740181|9 patients were enrolled beginning April 2009 to February 2010|
748297|NCT00740051||
748298|NCT00739999|Subjects were enrolled at 3 medical centers and participated in the study between 02 December 2008 and 13 May 2009.|Forty-five subjects were screened, and 39 subjects were assigned to study treatment.
748299|NCT00739973|A total of 2694 patients enrolled in the single-blind, placebo run-in period (2 to 4 weeks) of the study. A total of 1688 patients were randomized into the double-blind treatment period (8 weeks). Three patients were mis-randomized, as they were discontinued from the single-blind period and were not treated in the double-blind period.|
748300|NCT00739960||
748301|NCT00739934||
748302|NCT00739908|The study was conducted at 14 out-patient medical centers in the United States (US) from 16 September 2008 (date of first subject randomized) to 09 July 2009 (last subject's last visit).|A total of 587 subjects were screened. Three hundred and two (302) subjects failed to meet study entry criteria, and thus were screen failures. The top three reasons for screen failure were: IDS-SR30 total score cut-off for randomization not met (204 pts); presence of cardiovascular abnormality (18 pts) and Laboratory Abnormalities (14 pts).
748303|NCT00739882|First subject's first visit: 08 April 2008, last subject's last visit: 15 June 2009. Seventy six subjects entered the study, 46 completed the double-blind period and 31 of these then entered the open-label period. The remaining 15 entered an observational follow-up.|During the screening period, approximately 200 subjects were to be screened for trial eligibility within 14 days before Day 1. A total of 100 subjects had been screened at the time the trial was terminated, of whom 76 subjects were enrolled in the trial.
748304|NCT00739765||
748305|NCT00739752||
748306|NCT00739674|"First patient in: FEB-05-2008
~Last patient out: JAN-15-2010
~Total number of sites: 109 sites in Canada"|
748307|NCT00739661||
748308|NCT00739648||
748309|NCT00739596||
748310|NCT00739583||
748311|NCT00739336||
748312|NCT00739310||
748313|NCT00739297|Patients were recruited from 6 centers in the United States between July and December 2008.|117 participants were screened; 49 were excluded. Randomized patients met the following criteria during the prestudy period: FEV1 (Forced expiratory volume in one second) 50-85% predicted while withholding short-acting beta agonist (SABA) and reversibility of airway obstruction >12% following SABA at Visits 1 and 2.
748314|NCT00739102|A total of 250 patients were enrolled from August 14, 2008 to March 15, 2010 across 39 clinical sites in the U.S.|This is a multi-center, non-randomized, single-arm, prospective trial. Patients were eligible for enrollment if they met all inclusion criteria and none of the exclusion criteria.
748315|NCT00739063|Recruitment Period: July 22, 2008 to November 03, 2010. All recruitment done at UT MD Anderson Cancer Center.|Study terminated early due to slow accrual. Eleven patients were enrolled, only three received treatment.
748316|NCT00739050|First patient enrolled (FPE): 19 Sept 2007; Last patient enrolled (LPE) 22 Oct 2007. The protocol was terminated for Administrative Reasons|
748317|NCT00739024|8/2008 through March 2010, clinic setting|18 Participants signed Informed Consent. 5 did not qualify for randomization. 13 participants were randomized to Active Treatment or Placebo.
748318|NCT00738972||
748319|NCT00738894||
748320|NCT00738881||Twenty nine (29) pre-registered, screen failures (4 inadequate tissue, 1 investigator decision and one patient decision). Twenty three (23) patients were randomized, 2 patients withdrew from study prior to receiving any study treatment, thus a total of 23 randomized patients are evaluable for the primary and secondary endpoints.
748321|NCT00738699||
748322|NCT00738673|Cohort 1 comprised a broad spectrum of biochemically relapsed participants (on castrate level) on long term hormonal treatment in different stages of the disease (primarily advance stages), however not in need of chemotherapy. The second cohort was similar, although testosterone levels were to be above castrate level (≥0.32 ng/mL).|
748323|NCT00738543|Healthy volunteers recruited from August to December 2008 in the Microbiology Laboratory of University of Guanajuato, Mexico.|For stabilization of skin microbiota, all volunteers used neutral soap and shampoo without antiseptics over a period of two weeks, being advised to avoid swimming in pools.
748324|NCT00738530|A total of 821 participants were screened for this study, and 649 of these were randomized to receive double-blind treatment.|
748325|NCT00738426||
748326|NCT00738400||
748327|NCT00738374||
748328|NCT00738361||
748329|NCT00738283|Subjects were recruited in the Neonatal Intensive Care Unit at Texas Children's Hospital between September 2008 and May 2010.|
748330|NCT00738101|Recruitment to this compassionate use protocol began in September 2007. Patients were enrolled from mainly the inpatient and some from outpatient population at Texas Children's Hospital, Houston, Texas.|There was no wash-out or run-in period.
748331|NCT00738062||
748400|NCT00735072|Subjects were recruited from the HIV clinics at San Francisco General Hospital, Stanford University, Case Western Reserve University, and Rush University/CORE Center between September, 2008, and December, 2009.|All 45 enrolled patients were assigned to study intervention. We over-enrolled by 3 subjects given 2 premature treatment discontinuations and one subject with unavailable baseline peripheral blood mononuclear cell (PBMC) samples available for analysis.
748332|NCT00738049|Potential subjects who had undergone prior PET studies were contacted by mailings after a preliminary chart review. They received information about the study and were asked if they were interested in taking part in the study. If interested a screening visit was scheduled to determine if they met other inclusion/exclusion criteria.|After signing consent, study participants who met preliminary study criteria, were asked to come for the first PET scan. If rest homogeneity was too high by PET, the patient was excluded from randomization; otherwise the patient was randomized to receive placebo or study drug. 40 participants enrolled and 20 excluded by PET as explained above.
748333|NCT00738023||Four subjects were withdrawn due to exclusion criteria prior to randomization. Non-diabetic arm did not continue after the first intralipid infusion (period 1).
748334|NCT00737893||
748335|NCT00737737|This study enrolled patients with osteoarthritis at the National Institutes of Health Clinical Center. The last patient completed the study in 2012.|A total of 8 patients were enrolled in the study. Three patients did not qualify for the study, 1 patient elected to withdraw from the study to undergo joint surgery prior to receiving study drug and 4 patients completed the study.
748336|NCT00737711|The study was conducted from 08 July 2008 to 31 May 2009 across 16 centers in India. A total of 189 participants were enrolled in the study.|
748337|NCT00737698||There were 86 enrolled and 71 completed the study
748338|NCT00737672||
748339|NCT00737633|This is an extension study to OB-202 (NCT00486291) and DM-230 (NCT00600067)|
748340|NCT00737594||9 participants were recruited, but the study terminated before data were collected
748341|NCT00737568|Participants were enrolled at study sites in North America, Europe, and New Zealand. The first participant was screened on 30 September 2008. The last study visit occurred on 09 February 2015.|752 participants were screened. Randomization was stratified by hepatitis B e antigen (HBeAg) status (negative or positive) and alanine aminotransferase (ALT) level (≥ 2 × upper limit of normal [ULN] or < 2 × ULN) at screening.
748342|NCT00737529|Participants were enrolled and treated at 42 centers in 12 countries: US/ Puerto Rico, France, Israel, Belgium, Spain, Turkey, Austria, Hungary, Italy, Colombia, Germany, and Singapore.|All participants were required to have local histologic confirmation of Mantle Cell Lymphoma (MCL) for entry into the study.
748343|NCT00737477||
748344|NCT00737464|A total of 132 participants were enrolled from 26 August 2008 to 12 September 2009 at 11 study sites in India.|
748345|NCT00737438||
748346|NCT00737360|The patient enrollment was started from 24/Sep/2008 and terminated as of 30/Sep/2010. In the nasopharyngeal carcinoma (NPC) subgroup and squamous cell carcinoma (SCCHN) subgroup of stage 1, 13 and 14 patients were enrolled, respectively. For both subgroups subsequent enrollment was not reopened for the second stage, thus 27 patients were enrolled.|
748347|NCT00737282||
748348|NCT00737243|Between October 2008 and December 2011, 289 subjects in the United States with CUP were enrolled and had a molecular assay of biopsy tissue. 252 (87%) subjects had a successful assay performed; 223 subjects were treated and 29 were withdrawn (16 no longer met eligibility criteria and 13 were removed because of patient decision).|252 subjects had successful assays. 223 subjects were treated and 29 were withdrawn prior to treatment. 194 received assay-directed therapy; 29 received empiric CUP therapy. Patients receiving assay-directed therapy were divided into 2 groups: 1) more responsive tumour type; and 2) less responsive tumour type.
748349|NCT00737204|Patients were recruited from community based organizations and healthcare clinics that provide services to persons with HIV, by placing flyers on bulletin boards and in waiting areas.|A total of 114 patients were screened for eligibility, 25 had medical or psychiatric exclusion criteria, 7 were active substance users, 4 were taking stimulants, 3 were not clinically fatigued, 5 declined participation, and 70 were randomized. Of the 70, 64 completed the 4-week trial.
748350|NCT00737178|Women presenting to Columbia University's Special Gynecology Services for medication abortion will receive comprehensive contraceptive counseling. Those interested in the Intrauterine Device (IUD) for contraception will be offered study participation. Those who accept enrollment in the study and sign consent will be randomized into 1 of 2 groups.|For both groups, the routine 1 week follow-up visit will confirm a successful medication abortion by passage of gestational sac on sonogram. Endometrial stripe thickness will be also be noted. For both groups a transvaginal sonogram will be performed immediately after IUD insertion to confirm IUD position.
748351|NCT00737100||
748352|NCT00737061|Subjects were enrolled in the trial from 16 investigative sites between November 13, 2002 and April 28, 2005. Fourteen sites were located in the US and two were international sites.|770 subjects were enrolled: 75 withdrew consent and 50 were excluded for pathology/procedural criteria. All subjects were enrolled on an intent to treat (ITT) basis. The ITT population included all patients who were enrolled in the study and had device placement attempted. 645 subjects had treatment attempted. No comparative assessment was made.
748353|NCT00737048||
748354|NCT00736996||
748355|NCT00736957||219 participants were enrolled in this study out of which 29 participants did not meet the criteria to transfer to treatment period 1.
748356|NCT00736944|Recruitment was open from 12/19/08-10/18/11 at the Siteman Cancer Center (a medical clinic).|
748357|NCT00736879|Study initiated 22 September 2008 and completed 29 December 2009 in drug naive participants with type 2 diabetes mellitus who had inadequate glycemic control, defined as an hemoglobin A1c (HbA1c) greater than, equal to ( ≥) 7.0% and less than equal to (≤) 10.0%, with diet and exercise.|497 enrolled in Qualification Period: 297 completed: 13 withdrew consent, 1 lost to follow up (LTF), 1 pregnancy, 183 no longer met criteria, 2 other; 297 entered Placebo Lead-In Period: 282 completed: 3 withdrew consent, 4 LTF, 5 no longer met criteria, 3 other. 282 treated Double Blind; Follow Up visit: 4 weeks ± 5 days post treatment completion.
748358|NCT00736853||
748359|NCT00736840|414 subjects were collected in 11 sites; 8 in the United states and 3 in Israel. Recruitment began in August 2008 and was completed Sep 2009.|4 sites, 1 in Israel and 3 in the United States recruited most of the subjects. Patients with chronic liver disease and recent biopsies performed or planned were approached. Exclusion criteria focused mostly on issues that would affect accuracy of breath test.
748360|NCT00736723||
748361|NCT00736645||
749389|NCT00688623||Eighty-two patients were screened and 73 were treated with study drug.
749390|NCT00688597||
748362|NCT00736632|Potential participants will contact the principal investigator or research team through recruitment materials including emails to Washington University/Barnes Jewish/Children's staff, flyers, referrals through other physicians or the recruitment enhancement core, the Veterans Affairs Medical Center and Grace Hill Family Medical Center.|The third arm signed consent and are enrolled in the study but only for a single blood draw. They were not randomized and did not receive any intervention. No data was collected for any pre-specified primary or secondary outcomes from these participants.
748363|NCT00736580||
748364|NCT00736502|There were 280 patients enrolled but two patients were lost to follow up before the second visit (2 weeks). For these two patients no information about Nevirapine intake could be assessed. So they were not included in the treated set which was used for most of the analyses.|This was an observational, non-interventional, uncontrolled, prospective post marketing study.
748365|NCT00736489|The study has been performed in Sweden and Denmark at two University hospital clinics and two CROs. The recruitment period was between 11 August 2008 to 22 October 2008.|
748366|NCT00736476|Subjects were recruited from a single study center in Germany|All subjects enrolled were included in the trial.
748367|NCT00736450||"Of the 37 subjects consented, 19 were Not ABC gene type positive so were removed from the study.
~Of the 18 remaining eligible, 4 patients opted for standard of care and withdrew from the study.
~13 subjects had microarray analysis conducted with tissue."
748368|NCT00736385|11 subjects signed consent to participate. 2 subjects were screen failures. 9 subjects were randomized.|
748369|NCT00736333||
748370|NCT00736255|Recruitment ended in March 2011 at the Duke.A total of 59 subjects were screened. 24 did not pass screening while 35 were eligible. Of the 35 screen passers, 32 were randomized to receive either LDX or placebo, 3 were withdrawn prior to randomization. Of the 32 randomized, 17 received LDX and 15 received placebo. 14 completed on each arm.|There were 24 screen fails. Reason for Screen Fails include:Did not complete screening - 2,Carbon monoxide too low - 3,Positive Urine drug screen - 3,Physical health reasons - 5,Psychiatric comorbidity - 11
748371|NCT00736242||Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to violation of inclusion criteria, violation of exclusion criteria and no application of peginterferon alfa-2b (PEG-IFN alfa-2b).
748372|NCT00736229|Recruitment start: October 2008 Enrollment complete: June 2010 Recruitment location: Coronary Intensive Care Unit at Saint Luke's Hospital of Kansas City All eligible patients providing informed consent were assigned to a single group: exenatide infusion|All glucose lowering medications were discontinued prior to infusion of exenatide to study the relation between exenatide and blood glucose.
748373|NCT00736190||
748374|NCT00736125|during pre-op workup for TKA, patients were informed about study and asked if they wanted to participate.|
748375|NCT00736099||
748376|NCT00736073|Subjects scheduled for ERCP as outpatient procedure in Duke clinic between Aug 2007 and October 2009|Investigational product to be given 4 hours before procedure
748377|NCT00736034|Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.|
748378|NCT00735969||
748379|NCT00735943||
748380|NCT00735917|Nineteen patients with gemcitabine-resistant metastatic pancreatic cancer were enrolled from four U.S. locations from October 2008 to January 2011.|All 19 patients accrued to this study were used to report endpoints.
748381|NCT00735904||
748382|NCT00735878|Participants will be recruited from inpatient and outpatient populations at DHMC and through physician referrals.|
748383|NCT00735839||
748384|NCT00735826|Patients with clinical Stage I, II, III A NSCLC or Stage I, II , III esophageal cancer or Stage I, II, III, IV A Head and Neck cancer and a pre-treatment biopsy having at least 3 unstained slides were eligible. Patients were recruited from the oncology clinic.|
748385|NCT00735787||
748386|NCT00735709|Participants took part in the study at 51 investigative sites in Australia, Croatia, France, Germany, Latvia, Lithuania, Malaysia, Netherlands, Poland, Republic of Korea, Russia, South Africa, Taiwan, and Ukraine from 14 August 2008 to 13 August 2009.|Participants with a diagnosis of major depressive disorder were randomized equally in 1 of 4 treatment groups, once daily placebo, 1 mg, 5 mg, or 10 mg vortioxetine.
748387|NCT00735696||52 participants signed informed consent
748388|NCT00735670|Recruitment into the final protocol began in May 2009 and continued through July 2011. Participants were recruited from the surrounding community through clinics, existing research studies, and community organizations.|Because of challenges of recruiting inpatients with new injuries, the final modification to the protocol was to restrict inclusion criteria to those with chronic SCI (>6 months after injury) and the objective of the study shifted from preventing a major depressive episode to a reduction in symptoms. Therefore 13 / 34 enrolled were ineligible.
748389|NCT00735644|The study participants were enrolled from 02 August 2008 through 27 March 2009 at 3 clinic sites in Thailand and 5 clinic sites in the Philippines.|A total of 1200 participants who met all of the inclusion and none of the exclusion criteria were randomized, 1199 were vaccinated in this study.
748390|NCT00735618|Recruitment Period: 7/09/2008 through 7/10/2008. All participants recruited at University of Texas MD Anderson Cancer Center.|One of twenty enrolled participants did not meet eligibility criteria and was excluded from the study.
748391|NCT00735553||
748392|NCT00735475||
748393|NCT00735462||
748394|NCT00735449||
748395|NCT00735436||
748396|NCT00735397|This was an open-label Extension (OLE) study for participants who completed one of the following double-blind (DB), placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972), E2007-G000-305(NCT00699582), and E2007-G000-306 (NCT00700310).|From a total of 1218 participants who provided informed consent, 2 participants were lost to follow-up and did not have any postbaseline safety data after the first OLE dose.
748397|NCT00735371||
748398|NCT00735306||
748399|NCT00735254||
748401|NCT00735007|"First Patient First Visit : 30 July 2008 Last Patient Last Visit: 27 January 2009
~15 specialist neurology centres in 6 countries: Canada (3 sites), Germany(4 sites) , Italy (2 sites) , Spain(3 sites), Sweden (1 sites), USA(2 sites)"|
748403|NCT00734968||161 subjects were consecutively enrolled. 8 subjects were lost to protocol errors. 76 subjects were randomized to treatment and 77 to placebo. 1 subject from each arm was lost to follow up. 75 subjects in the treatment arm and 76 in the placebo arm were in the final analysis.
748404|NCT00734929|The study took place at Duke University Medical Center from September 2007 to June 2009, 146 signed the consent form, 115 were randomized, 104 completed the study|
748405|NCT00734903||Of 103 screened, 82 were eligible, 21 ineligible. Of 82 eligible, 66 completed baseline and were randomized; 16 did not complete baseline.
748406|NCT00734851||36 participants consented. 2 participants withdrew consent prior to going on treatment. 34 participants started treatment. 2 participants withdrew while on treatment. 18 withdrawn by PI.
748407|NCT00734799|Study participants were recruited between 1/1/2008 and 12/31/2009 using flyers placed throughout the VA hospital and a community Veteran Center, and through letters sent to recently deployed veterans who had enrolled in a VA research registry and who had agreed to be recontacted for participation in VA research.|Of the 93 self-referred prospective study participants, 22 individuals (15 men and 7 women) met study selection criteria, completed baseline procedures, and were subsequently randomized to treatment conditions.
748408|NCT00734747||
748409|NCT00734734|Overall, 64 participants ≥65 years of age were enrolled at 2 sites in Italy.|Blood samples for the determination of antibody titers were drawn on Day 0 prior to vaccination.
748410|NCT00734656|Non-treatment seeking social drinkers recruited from community settings 2007-2010.|A total of 148 subjects enrolled, 31 subjects were excluded for not meeting entrance criteria, 23 subjects withdrew before first dose of study medication. 94 subjects were randomized to one of 24 possible laboratory session sequences for exposure to each of 4 treatment conditions.
748411|NCT00734630|Recruitment occured from August 2008 through November 2009 at 76 US sites.|Placebo washout phase was required for patients currently on anti-hypertensives at screening followed by a losartan or lisinopril run-in phase before assignment to Placebo or Nebivolol arms. Patients who were untreated at screening started the study at the open-label lead-in phase.
748412|NCT00734617|Recruitment start date: 8/20/2007 Recruitment end date: 3/19/2008 Recruitment locations: Duke Center for Nicotine & Smoking Cessation Research offices located in Charlotte, Durham, Raleigh and Winston-Salem NC.|"Participants were excluded for the following reasons:
~DID NOT MEET INCLUSION CRITERIA: 78 MET EXCLUSION CRITERIA: 74 UNABLE TO MEET STUDY REQUIREMENTS: 9 REFUSED TO PARTICIPATE: 18 LOST TO CONTACT (PRIOR TO V1): 30 LAB RESULTS: 64 MD/PA REFUSAL: 179 30 DAYS PAST PHYSICAL SCREENING: 1"
748413|NCT00734604||
748414|NCT00734591|This study had retrospective and prospective components. Individuals who participated in Exubera-controlled trials that were still active in 2003 or later participated in the retrospective part of this study (Follow-Up Study for Exubera; FUSE). Individuals from sites participating in the prospective part of FUSE were eligible.|
748415|NCT00734578||
748416|NCT00734539||
748417|NCT00734500||
748418|NCT00734474||
748419|NCT00734409|Patients were in the Medical ICU or Neuro ICU at Duke University Hospital or the mixed ICU at Durham Regional. If patients met all inclusion criteria and no exclusion criteria, the attending was asked if patient's legally authorized representative (LAR) could be approached for consent. Enrollment started May of 2008 and closed April of 2011.|Patients were only excluded from the trial after consent and prior to randomization if they no longer met inclusion criteria, for instance the medical team decided to remove sedatives.
748420|NCT00734344||
748421|NCT00734305||
748422|NCT00734214||
748423|NCT00734162|Participants were enrolled at 3 sites in the United States, 8 sites in Poland, 3 sites in Romania, 2 sites in Bulgaria, 2 sites in France, 2 sites in Spain, and 1 site in Turkey. The first participant was screened on 03 December 2008. The last study visit occurred on 02 December 2015.|149 participants were screened.
748424|NCT00734149|Recruitment period occurred from July 2004 to December 2007 at Duke University Medical Center.|
748425|NCT00734097|Participants with persisting symptoms of Gastroesophageal Reflux Disease (GORD) despite previous treatment with a full dose proton pump inhibitor were enrolled across the Argentina (6 sites), Chile (3 sites) Colombia (9 sites) and Venezuela (2 sites).|All participants received 8-weeks open label esomeprazole treatment.
748426|NCT00734071|Participants took part in the study at 33 investigative sites in the United States from 25 June 2008 to 06 March 2009.|Participants with a diagnosis of generalized anxiety disorder were enrolled equally in one of two treatment groups, once a day placebo or 5 mg vortioxetine.
748427|NCT00734032|The study was planned in 100 dyslipidemic male or female participants, aged 20 to 80 years, undergoing statin therapy and no change in lipid-lowering medication or dose during the 4 weeks prior to randomization from 26 August 2008 to 16 January 2009 at 7 centers in Japan.|Out of 116 participants screened, 9 were screen failures; 107 participants were randomized in a ratio of 1:1:1:1, to receive placebo or any 1 of the 3 doses of SB-480848 (40 milligram [mg], 80 mg, 160 mg), prior to which they continued their statin therapy with no change in lipid-lowering medication or dose during 4 weeks of Run-in period.
748428|NCT00733993||
748429|NCT00733980|A total of 150 female participants, with major depressive disorder (MDD), were randomized in the study. The study was conducted from 02 October 2008 to 18 June 2010 at 18 centers across the United States.|
748430|NCT00733954|First subject was enrolled on August 22, 2007 and the last subject enrolled was February 20, 2008. Investigative sites were located at academic institutions and private physician offices.|The specified wash-out period up to baseline was 14 days (topical steroid containing medication and/or UVB treatment, Dovonex, anthralin and/or tar); and 4 weeks (systemic corticosteroids, biologics and/or PUVA treatment).
748431|NCT00733824||
748432|NCT00733746||123 patients enrolled to this study. 4 patients cancelled prior to treatment and were not included in any analysis.
748433|NCT00733512|Subjects 18 years of age and older of either sex and any race. Diagnosis of cataracts in one or both eyes.|Subjects eligibility was determined at the preoperative visit.
748434|NCT00733499|The first patient was operated on 26 September 2006 and recruitment lasted for 28 months with the last patient operated on 20th January 2009.|Consent was taken for 232 knees. 10 subjects were deemed unfit for surgery, 5 subjects were deemed ineligible for the study and 12 subjects were not randomised for the study. This left 205 subjects in the safety population that could be randomised for the study.
748438|NCT00733356|"Subjects were recruited through flyers and other advertising and were seen in a researach clinic setting. Subjects were recruited from july 2008 until May 2009. A primary diagnosis of ADHD was confirmed.
~All subjects were also given a K-BIT intelligence test and had to achieve a score of at least 80 to be enrolled."|All subjects who met study criteria for ADHD and intellectual ability who were also healthy and had no other co-morbid diagnosis except possible ODD were enrolled in the study. Any subjects taking stimulant medication before the trial did a 2-day washout before baseline. 42 subjects consented, 5 didn't meet criteria, 9 withdrew consent.
748439|NCT00733343||
748440|NCT00733330|86 subjects were enrolled at 5 sites.|2 subjects were intraoperatively excluded and did not receive surgery.
748441|NCT00733304|This was an extension study to protocol MD7108240 (NCT00612456). It was a multi-center, double-masked, randomized, parallel-group dose-ranging study of repeat topical ocular doses of pazopanib from 25 June 2008 to 9 September 2009. The study was conducted in 14 centers in the United States, Italy, and Australia.|Randomized participants without progression of age-related macular degeneration (AMD) and/or requiring rescue therapy during the 28-day treatment period in study MD7108240 (NCT00612456) were included in this study. A total of 42 participants were randomized in the study.
748442|NCT00733291|64 subjects currently wearing hydrogel or silicone hydrogel lenses on a daily wear schedule for at least two weeks were enrolled between 1/7/08 and 2/1/08 by 4 US optometry sites|18 hours of no contact lens wear (glasses only) served as the wash out before Period 1. This reporting group includes all enrolled and dispensed participants as treated.
748443|NCT00733278|Women in prenatal clinic were approached in the third trimester if they were to be scheduled for elective C-section. If they were interested in using Copper IUD, their informed consent was obtained. At the time of elective C-section, their continued interest in study participation was verified.|
748444|NCT00733226|This study was a randomized, double-blind, placebo-controlled, parallel group study with OM-85 (Broncho-Vaxom; OM PHARMA; Meyrin/Geneva, Switzerland) in patients with recurrent wheezing and performed between August 2007- September 2008 in the outpatient department of Pediatric Allergy of Kecioren Education and Research Hospital in Ankara, Turkey.|"This study comprise 3 months of active treatment and 9 months of follow-up. Duration of the trial was 12 months.
~Eighty of 100 children were selected to enter the trial. 20 children were not included in to the study because of not meeting the inclusion criteria."
748445|NCT00733135|133 subjects were enrolled in this study between October 30, 2008 and October 13, 2010. The type of location included hospitals with catheterization labs and/or vascular centers.|
748446|NCT00733096|84 patients were enrolled between 2008 and 2011|80 patients were excluded before assignment
748447|NCT00733005||
748448|NCT00732992||
748449|NCT00732940||
748450|NCT00732901||The enrollment number was the number of participants who signed the informed consent. The Participants who Started in the Participant flow module were number of participants who completed the screening and met inclusion criteria to start medication.
748451|NCT00732875|Subjects showing clinical response at Week 30 of a previous double-blind study of infliximab vs placebo (P04280,NCT00202852) were eligible for this study. A total of 105 subjects were eligible (67 from previous placebo & 38 from previous infliximab group) for this extension study, among whom a total of 92 enrolled to participate in the extension.|Of the 92 enrolled subjects, 61 were from the placebo group and 31 from the infliximab group of the previous study.
748452|NCT00732758|We enrolled healthy 8- to 14-year-old children from October through March of 2008 through 2011.|Children receiving vitamin preparations underwent a 1-month washout before enrollment. Of 355 children assessed for eligibility, 304 were deemed eligible and among these 157 agreed to participate.
748453|NCT00732680||
748454|NCT00732654||33 patients underwent screening Double-Blinded Placebo-Controlled Food Challenges (DBPCFCs). Two subjects failed screening because they tolerated at least 2.5g at the initial DBPCFC. One subject declined to continue in the study after the food challenge. 30 subjects were randomized.
748455|NCT00732641||
748456|NCT00732615|124 Subjects were enrolled between 12/2008 and 9/2011 at 28 clinical sites in North America, Western Europe and Hungary.|"Subjects underwent a screening and stabilization period (optimization) of up to 16 weeks prior to enrollment.
~Please note: Data for 10 subjects were excluded."
748457|NCT00732498||
748458|NCT00732472|Participants=par.; umeclidinium=UMEC. A total of 37 unique par. were enrolled in the study; however, 1 par. was randomized and dosed on two separate occasions and is counted as two separate par. on all outputs (thus, 38 par. started study treatment).|Participants were assigned to one of two cohorts: UMEC 250 micrograms (μg) once daily (QD) or placebo (Cohort 1) and UMEC 1000 μg QD or placebo (Cohort 2) for 7 days. After reporting of Cohorts 1 and 2, it was found that par. in Cohort 2 received UMEC 250 μg in error. Cohort 3 was then recruited, in which par. received UMEC 1000 μg QD or placebo.
748459|NCT00732381||
748460|NCT00732303||
748461|NCT00732251||7 subjects screen failed.
748462|NCT00732238||
748463|NCT00732225|Preoperatively, subjects were examined to ensure they met the inclusion/exclusion criteria. Patients were >49 years of age, of any race and either gender. Patients had operable cataracts in at least one eye and were able to provide informed consent|As access to Ophthalmic Viscosurgical Devices (OVDs) was limited, patients received whichever OVD was in stock at the time of surgery. 51 patients had a different OVD used in each eye. As a result, their demographic data is included in 2 OVD groups, resulting in a total of 224 patients (when group totals are added).
748464|NCT00732212||
748465|NCT00732199|Participants were recruited by posting fliers at the sites approved by the Detroit VA clinical investigations committee and Wayne State IRB (institution review board). They completed a phone interview. If they qualified based on the inclusion/exclusion criteria they completed an informed consent. Dates 2008 to 2014.|
748466|NCT00732160||11 participants did not start the study (5 Participants did Not Meet inclusion or exclusion criteria, 6 declined participation)
748467|NCT00732069|Recruitment started in September 2008 and ended in January 2010 in Vanderbilt outpatients Dialysis Center.|Three consented participants were excluded because of hyperkalemia, hypotension and uncontrollable hypertension.They were enrolled but did not start medication and were considered screen failures. The participants required a washout period from either an agiotensin receptor blocker or an angiotensin converting enzyme inhibitor.
748468|NCT00732030|Patients were >21 years of age, of any race and either gender. Patients had operable cataracts in at least 1 eye and were able to provide informed consent. Patients were free of systemic diseases affecting ocular health and had a predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D) by the AcrySof Toric calculator.|During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled.
748469|NCT00731939||
748470|NCT00731874||34 subjects consented for the study; 11 were enrolled but not randomized due to the following: withdrew consent/refused transplant biopsy (n=4); donor specific antibody detected during screening (n=3); excluded by findings of kidney transplant biopsy (n=2); fluctuation in renal function (n=1); study terminated prior to randomization (n=1).
748471|NCT00731822||Participants meeting eligibility criteria at screening and randomization criteria at the end of the Screening Period (SP) were randomized to 1 of 2 treatments: Fluticasone Furoate (FF)/Vilanterol (GW642444) 400/25 microgram (µg) inhalation powder or matching placebo. 89 participants were screened, of whom 60 were randomized.
748472|NCT00731783||
748473|NCT00731770||
748474|NCT00731731||
748475|NCT00731692|Patients were randomized equally to receive either fingolimod or placebo. Patients initially randomized to fingolimod 1.25 mg/day or matching placebo groups switched in a blinded manner to fingolimod 0.5 mg/day or continued on placebo after amendment in Nov. 2009. Patients were randomized to receive either fingolimod 0.5 mg/day or placebo..|Prior to protocol amendment 147 patients received 1.25mg of FTY720; post protocol amendment 5 not all 147 patients switched to 0.5mg FTY720, only 121 switched and their data is presented under the 0.5mg dose.
748476|NCT00731679||
748477|NCT00731666||
748478|NCT00731653|Following their participation in the CBM-IT-01 study, subjects were offered the opportunity to participate in this open-label extension study. The study was conducted 9 study centers between June 2008 and February 2009.|
748479|NCT00731640|This is a retrospective study that required patients with unilateral implantation of the AcrySof ReSTOR Intraocular Lens (IOL). Patients were to be free of conditions or ocular co-morbidities that may affect visual acuity.|During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. This study was not randomized.
748480|NCT00731614||While 59 participant initially enrolled, 1 completed no assessments, so the overall n= 58. In addition, 4 did not complete the first week assessment session, which is why patient flow ends up listing 54 at the start rather than 58.
748481|NCT00731549|This open label Phase 3 study enrolled participants from the maintenance phase of study NCT00705783 (31-07-246) and study NCT00706654 (31-07-247) and new participants. Participants received aripiprazole intramuscular (IM) depot as maintenance treatment.|Study comprised of screening phase (applicable if enrolled late/new participants/received antipsychotic treatment other than aripiprazole), conversion phase (Phase 1, to convert from other antipsychotics to aripiprazole), oral stabilization phase (Phase 2-aripiprazole 10-30 mg), and open-label IM phase (Phase 3-aripiprazole 400 mg IM depot).
748482|NCT00731484||
748483|NCT00731341||
748484|NCT00731211||
748485|NCT00731198||
748486|NCT00731133||
748487|NCT00731120|Participants took part in the study at 41 investigative sites in the United States from 17 June 2008 to 16 February 2009.|Participants with a diagnosis of generalized anxiety disorder were enrolled equally in one of three treatment groups, once a day placebo or 2.5 or 10 mg vortioxetine.
748488|NCT00731094||
748489|NCT00731055|Twenty-one participants were recruited in an urban hospital setting through advertisement in local newspapers and flyers and 16 particiopants were enrolled. Study was conducted at the NYS Psychiatric Institute|
748490|NCT00731042||After screening, there was a 5-days washout prior to enrollment into period 1. This was then followed by another 5-days washout between periods 1 and 2.
748491|NCT00730964||
748492|NCT00730925||
748493|NCT00730912||
748494|NCT00730886||
748495|NCT00730847|Since this was a post-marketing study (PMS), subjects may have received one or two doses of Cervarix outside of the PMS.|"Out of 743 subjects enrolled in the study, only 596 subjects received study vaccination.
~The whole set of data was not cleaned for this study. Analysis was performed on subjects with cleaned data and on subjects with missing data or unresolved data queries, or both. The overall group includes both cleaned and not cleaned data."
748496|NCT00730756||
748497|NCT00730730||
748498|NCT00730691|Participants took part in the study at 71 investigative sites in the United States from 20 June 2008 to 27 February 2009.|Participants with a diagnosis of generalized anxiety disorder were enrolled equally in 1 of 5 treatment groups, once a day placebo, 2.5 mg, 5 mg or 10 mg vortioxetine, or 60 mg duloxetine.
748499|NCT00730639||395 participants were enrolled and 306 were treated. 89 were not treated because they failed to meet study eligibility criteria or died prior to the initiation of treatment. All participants had received at least 1 prior cancer therapy. Study is on-going.
748500|NCT00730522||
748501|NCT00730483|13 patients were enrolled on this protocol at Johns Hopkins University. This study was terminated early due to high incidence of bilomas in patients receiving TACE treatment.|
748502|NCT00730405|From 16 July 2008 to 19 February 2010, total of 582 participants with onychomycosis were randomized in 5 different arms at 26 centres in the United States, 3 centres in the Canada and 1 centre in the Iceland.|
748503|NCT00730353|Trial opened to accrual November 2008; opened at both community and academic performance sites.|This trial was limited to patients with advanced esophageal cancer.
748538|NCT00728962|Each site endeavored to enroll a maximum of 15 patients, with enrollment efforts beginning in March 2005. Enrollment period remained open at all sites until April 2006. Three participating sites are Universities and four are private practices.|Pre-treatment included a screening visit(enroll those meeting all study inclusion criteria), signing informed consent, and pre-surgical data collection. Within 48hrs., impressions of the patient's treatment areas are taken for making a temporary prosthesis. Patients are then scheduled for implant placement surgery.
748504|NCT00730327|Patients were enrolled at 15 investigational sites across the US, between 6/20/2008 and 10/10/2010. Patients were either enrolled as run-in subjects (mentored cases which were enrolled prior to randomized subjects in order for physicians to gain experience with placing and removing the device) or as subjects for randomization.|448 subjects were enrolled (defined as signing the informed consent), 44 of which were run-in subjects. Prior to randomization, 131 subjects were screen failures. 273 subjects were randomized to the BIB (137) and control groups (136). 12 BIB and 6 control subjects discontinued prior to treatment. 125 BIB and 130 control subjects began treatment.
748505|NCT00730275||
748506|NCT00730236|The study was performed from 18 Dec 2007 to 13 Oct 2011. A total of 11 medical clinics participated in the study.|6-week Run-in Phase. Following screening, patients entered a 6-week Run-in Phase to stabilize their regimen of current lipid-lowering therapy(ies) and to be placed on a low-fat diet containing <20% energy from fat.
748507|NCT00730171|Participants were categorized as either randomization-ineligible (RI) from the lead-in double-blind trials MCP-103-302 or MCP-103-303, or rollover (RO) from lead-in double-blind trials MCP-103-302, MCP-103-303, and from Phase 2 double-blind studies MCP-103-004, MCP-103-005, and MCP-103-201, or MCP-103-202 (See Detailed Description for NCT numbers).|A total of 1743 participants were enrolled in the study; 1725 received ≥1 dose of open-label linaclotide (included in the Overall Safety Population). One participant enrolled twice in the study under 2 ID numbers and is included as an RI participant in the CC Safety Population, and as an RO participant in the IBS-C and Overall Safety Populations.
748508|NCT00730158||
748509|NCT00730132||
748510|NCT00730041|All initial study candidates were recruited from the Investigator's general patient population and related physician referral base. The Investigator or designee screened each candidate to ensure that all inclusion and exclusion criteria were met.|After initial screening, all subjects had a polysomnogram (PSG) with continuous positive airway pressure (CPAP) titration to determine the therapeutic pressure. Subjects collected a minimum of two weeks of SmartCard data using CPAP machine prior to the intervention in order to establish baseline usage info. Group was determined at the intervention.
748511|NCT00730028|Participants were non-immunocompromised out-patients age 6 months to 85 years with SSTIs not requiring hospital admission were recruited across 6 sites from communities with an anticipated prevalence of community-associated MRSA. Participants were enrolled between April 13, 2009 and January 13, 2015|
748512|NCT00730015|Patient Recruitment occurred from August 2008 to August 2009 at 109 U.S. study centers.|Patients went through a 14 to 21 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS).
748513|NCT00729937|Participants were recruited between 13APR2009 and 16APR2013 from those who presented with an abscess, infected wound, or cellulitis at emergency departments at each of the clinical sites.|
748514|NCT00729924||
748515|NCT00729859|Subjects were recruited using rosters from prior research studies, newspaper and online advertisements. Recruitment began December 2008 and ended March 2010.|"Before study procedures,2 withdrew consent and 1 was withdrawn by the investigator for missing appointments.4 failed inclusion criteria(1-anemia,1-low testosterone,1-high BMI,1-medications.
~31 men enrolled. 22 men completed."
748516|NCT00729846||
748517|NCT00729833||
748518|NCT00729807||Pre-treatment Evaluation: Following informed consent, patients will be scheduled for a biopsy of accessible tumor. The specimen will be assessed for p53 status by sequencing and S100B, p53, and p21 expression
748519|NCT00729781||
748520|NCT00729690|Forty-eight patients scheduled to undergo elective primary Total Knee Replacement (TKR) for osteoarthritis by 2 orthopedic surgeons were recruited at the Rush University Medical Center (Chicago, Illinois).|
748521|NCT00729677||The original intent had been to analyze data on 100 chemotherapy cycles in 100 subjects. Instead, in order to accelerate accrual, we analyzed data on 1 cycle in 24 subjects and 2 cycles in 40 subjects.
748522|NCT00729651|"17 centers participated in this study (11 - Medical Center of the University, 7 - General Hospital).
~FPE(First patient enrolled) : March-2008, FPI(First patient in) : April-2008, LPO(Last patient out) : April-2009."|
748523|NCT00729612|Patients were enrolled in the trial between September 2008 and December 2011.|
748524|NCT00729586|Seventy-three patients were registered to this trial between 9/29/08 and 11/22/10. On 10/19/09 the trial was suspended and the combination arm was permanently closed to accrual because an excess of venous thromboses was noted. The single agent arm continued to the second stage of accrual on 5/24/2010.|
748525|NCT00729560||
748526|NCT00729521|20 interested communities were randomized to one of the three groups using a block randomization method, taking into account whether the lead agency was a health department or aging agency and whether the community had 0 or 1 or more Stepping On fall prevention program leaders already.|
748527|NCT00729482||
748528|NCT00729469|First patient was screened on August 04, 2008 and last patient completed on July 30, 2009|Subjects reporting moderate to severe VVA symptoms of vaginal dryness or vaginal pain associated with sexual activity as the most bothersome symptom (MBS) at the initial screening visit were allowed to continue in the screening phase of the study. Each subject entered 1 of 2 strata based on their self-reported moderate to severe MBS
748529|NCT00729430||
748530|NCT00729378|Recruitment was performed for three years (2007-2009) in a total of 16 elementary and middle schools (9 intervention and 7 control) in two Tucson, Arizona area school districts. Recruitment consisted of attending back to school days and holding recruitment assemblies before or after school.|Intervention and control schools designated prior to recruiting. Schools were selected based on size, demographics, and student flow from elementary to middle school to prevent contamination. 739 participants completed informed consent process (agreed to participate); only 509 scheduled measurement appointments and completed study measurements.
748531|NCT00729365||
748532|NCT00729326||
748533|NCT00729248|Recruit donor/recipient renal transplant subjects for blood draw before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combinations: Recipient PMBC + Donor PBMC + No drug Recipient PMBC + Donor PBMC + Tacrolimus (TAC) Recipient PMBC + Donor PBMC + Sirolimus (SRL)|
748534|NCT00729183||214 participants who met inclusion criteria were randomized into either the Odanacatib 50 mg arm (N=109) or the Placebo arm (N=105).
748540|NCT00728936|"The study enrolled patients with chronic infection with hepatitis C virus (HCV) who were null responders to prior treatment with pegylated-interferon-alfa (peg-IFN-α) plus ribavirin. The study included patients with any HCV genotype."|All enrolled subjects who qualified after the pre-screening period were assigned to a treatment group and treated.
748541|NCT00728923|Adult outpatients were recruited from the community starting August 2008 until July 2011.|
748542|NCT00728910|Recruitment lasted from June 2008 until February 2009.|Subjects washed out of current lipid lowering medications
748543|NCT00728884|Up to 200 patients will be enrolled across all participating centers, with enrollment efforts beginning in August 2005. Enrollment period remained until February 2007. Ten participating sites are private practices and two are Universities.|Pre-treatment included a screening visit (enroll those meeting all inclusion criteria),signing informed consent, and per-surgical data collection. Patients are then scheduled for implant placement surgery.
748544|NCT00728845|Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and the Robert Wood Johnson University Hospital-Hamilton in New Jersey from June 2008 through December 2010.|
748545|NCT00728819||
748546|NCT00728754|Up to 120 patients were enrolled across all centers, with enrollment efforts beginning in February 2005. Enrollment period remained open until June 2006. Two participating sites were Universities and four were private practices.|Pre-treatment included a screening visit (enroll those meeting all inclusion criteria), signing informed consent, and pre-surgical data collection.Patients returned for implant placement surgery, followed by temporary prosthesis placement at 2 months.
748547|NCT00728728||
748548|NCT00728689|Study period was approximately 2 weeks (from August 26, 2008 to September 8, 2008), plus a 30-day post-treatment follow up. The study was conducted at a Phase I Study Unit of a Clinical Research Center in Orlando, FL.|All participants needed to meet strict entry criteria. Sixty-three subjects were screened to randomize 12 subjects into the study.
748549|NCT00728507||
748550|NCT00728494||
748551|NCT00728481|Subjects with a clinical diagnosis of Eosinophilic Esophagitis (EE) were recruited by mail using a Mayo Clinic proprietary database and also by direct contact in the Mayo Clinic Esophageal Diseases speciality clinic in Rochester, MN. Subjects were enrolled from 3/2009 to 8/2010.|Patients with esophageal eosinophilic infiltration of greater than or equal to 15 eos/hpf as determined by 4 biopsies of the esophagus, then underwent a 24-hour transnasal catheter-based ambulatory pH study to determine amount of distal esophageal acid exposure, and were placed in one of 2 treatment arms based on positive or negative pH results.
748552|NCT00728468||
748553|NCT00728416||
748554|NCT00728260|Study participant accrual occurred from 18 October 2007 through 17 October 2010. Kaiser Permanente databases were reviewed for this study.|Medical utilization databases were reviewed for children 2 through 10 years of age receiving Menactra vaccine within Kaiser Permanente to identify the following medical care events during the 6 months after Menactra vaccination: all outcomes from hospitalizations and emergency department visits and selected outcomes from clinic visits.
748555|NCT00728182|Between September 16, 2008 and March 30, 2011, subjects were recruited to 10 hospitals in Canada and 3 in the United States.|12 subjects were randomized into study but did not receive drug:5 due to do endovascular aneurysm repair, 3 due to inability to obtain a pre-procedure MRI,2 due to pre-procedure ECG showing a QTc interval > 450 ms, 1 due to a fatal aneurysm rupture before drug, and 1 due to refusal by anesthesiologist to give drug to a subject with severe COPD.
748556|NCT00728130|"Treatment planning was performed for all patients in the multidisciplinary head and neck oncology forum before recruitment into the trial.
~Dates of recruitment: 06/11/2008 through 09/17/2009 Number of patients recruited: 23 Number of patient completing trial: 20"|
748557|NCT00727961||
748558|NCT00727909|Participants were recruited from Veterans scheduled for audiology appointments at the three participating VA sites: Nashville, Tennessee, Bay Pines, Florida, and Mountain Home, Tennessee. Recruitment occurred during the time period May, 2009 through February, 2011.|"All study participants were assigned into all three hearing aid treatments: Traditional Custom TC, Receiver-in-the Aid (RITA), Receiver-in-the-Ear (RITE). The sequence of treatments was counter-balanced to prevent an order effect.
~Eleven participants who consented withdrew or were excluded prior to the first condition hearing aid fitting."
748559|NCT00727857|Participants were enrolled at 134 investigative sites in the United States (including Puerto Rico), Argentina, Chile, Guatemala, Mexico and Peru from 13 June 2007 to 29 August 2008.|Participants who had not received treatment with antidiabetic medication 12 weeks prior to Screening were enrolled in one of three, twice-daily (BID) treatment groups.
748560|NCT00727844|Study patients recruited from 12/2008 to 5/2011 at the National Masan Hospital, Changwon, Korea and the National Medical Center, Seoul, Korea.|
748561|NCT00727740||
748562|NCT00727714|95 workers from two cement plants in Norway (located in the small cities of in Brevik in South-Norway and Kjøpsvik in the North-Norway) were examined in the winter sesons in 2008 and 2009.|The workers were required to be off work for at least two days before Medical examinations, then exposed to cement Production dust between 0 and 8 h and again between 24 and 32 h. Those not exposed in these periods were excluded. No unexposed controls were included, the participants were their own controls.
748563|NCT00727649|Outpatient medical clinic|
748564|NCT00727636|Location - Children's Hospital Boston, including Waltham Infusion Center, and Maine Medical Center. Patients were recruited during a scheduled clinical or Remicade infusion visit, a hospital admission, by contact through mail followed by a phone call, or through referral from local hospitals. Recruitment period -April 2008 through April 2010|
748565|NCT00727597|Patients ≥18 years of age who were ART-naïve (≤14 days of treatment with any ART agent), HLA-B*5701-negative, and had a screening HIV-1 RNA >5000 copies/mL. Patients were required to be of minority race or ethnicity; white, non-Hispanic patients were not eligible for this study.|
748566|NCT00727571||815 patients were enrolled; 21 of these could not be classified into the defined groups because of missing lab values at enrollment. Their anemic/CKD status is therefore not available.
748567|NCT00727558||
748568|NCT00727532|Study was open to enrollment at Northwestern University beginning June 2008, and closed to enrollment in September 2012.|
748569|NCT00727506||This study consists of 2 parts (phase I and phase II) with separate participants.
748570|NCT00727441||
748575|NCT00727298||Of 4485 total enrolled participants, 4465 received at least one infusion of infliximab and are included in the safety evaluation. 3228 of these participants were evaluable for all other study analyses.
748576|NCT00727272||
748577|NCT00727259||Enrolled: 1995 subjects; all questionnaires were returned for 940 subjects.
748578|NCT00727246||
748579|NCT00727220||
748580|NCT00727194|There were 26 IRB/IEC-approved study sites. Patients were screened at 13 Institutional Review Board/Independent Ethics Committee approved study sites; and 14 patients were randomized at 8 sites.|Patients received standard of care during the Screening Period. Patients were randomized to a treatment sequence to receive eculizumab in Period 1 followed by placebo in Period 2 or placebo in Period 1 followed by eculizumab in Period 2. Patients were permitted to continue on background immunosuppressive therapy throughout the study.
748581|NCT00727090||
748582|NCT00727064|Participants were recruited in the United States from June 2008 to August 2008.|"Participants were screened for cytochrome P450 2D6 (CYP2D6) genotype to identify 7 extensive metabolizers and 7 poor metabolizers (inclusion criteria). Eligible participants were then randomly assigned to a sequence group."
748583|NCT00727025|all woman undergoing bilateral breast reduction using the Wise pattern approach. Pts were recruited between Feb 2006 and Sept 2007|Patients declined
748584|NCT00726999||
748585|NCT00726986|A total of 18 patients were enrolled into the trial from 3 sites between August 2008 and November 2011. Patients were recruited from University Hospitals Case Medical Center and Cleveland Clinic in Cleveland Ohio and Columbia Presbyterian in New York.|
748586|NCT00726895||
748587|NCT00726882|Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in Study M10-351 Substudy 2 (NCT00696904) or Study M10-380 (NCT00851890).|
748588|NCT00726830|Recruitment Period: March 10, 2009 to October 1, 2010. Recruitment occured within University of Texas MD Anderson Cancer Center and Palmetto Hematology Oncology at Gibbs Regional Cancer Center.|
748589|NCT00726752||
748590|NCT00726739|All patients were evaluated for eligibility by one of the investigators prior to enrollment.|"This study requires concurrent registration to the University of Minnesota study MT1999-06: Vaccination with Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses (IRB # 9904M01581, CPRC #2002LS032)."
748591|NCT00726713|Of 373 patients screened, 214 entered the study , and 200 completed. The study was conducted at 6 participating U.S. sites|Inclusion criteria included individuals 25 and 80 years of age, documented diabetes Type 2, Peripheral polyneuropathy, adequate lower extremity vascular status, and subject competence. 17 exclusion criteria including an HbA1c >9, uncontrolled heart or lung disease, and vitamin B supplementation, contributed to the number of screening failures.
748592|NCT00726661|This study was conducted from 01 June 2008 to 31 December 2012 in the United States. A total of 1287 participants were enrolled.|Out of 1287 participants, 20 were not eligible for the study and were excluded. Of 1267 participants, 832 were observed in Chemotherapy cohort and 435 were observed in Hormonal Therapy cohort.
748593|NCT00726622||
748594|NCT00726609||
748595|NCT00726557||
748596|NCT00726453||
748597|NCT00726414||
748598|NCT00726375||
748599|NCT00726323|This study was conducted from 30 June 2006 till 18 August 2010 across 10 centers in the United States (US). A total of 60 participants with papillary renal-cell carcinoma (PRC) were planned to be enrolled.|A total of 74 participants with PRC were enrolled in the study.
748600|NCT00726232|This was a multicenter study with 2 sites in the United States and 4 sites in Italy.|
748601|NCT00726180||
748602|NCT00726063|Up to 165 patients are expected to be enrolled across all centers, with enrollment efforts beginning in August 2008. Enrollment period remained opent until December 2010.|Pre-treatment included a screening visit (enroll those meeting all protocol inclusion criteria), signing informed consent, and pre-surgical data collection. Patients returned for implant placement surgery, followed by restorative activities.
748603|NCT00726037|Recruitment for this study began on 06/18/2008 and ended on 01/09/2012|
748604|NCT00725985||
748605|NCT00725959|Recruitment began October 2010 and Ended May 2011 in community settings|
748606|NCT00725920||
748607|NCT00725842||
748608|NCT00725764|A total of 14 participants with advanced solid tumors were enrolled in this study. This study was conducted at up to 15 clinical sites in the United States.|
748609|NCT00725751||353 participants were enrolled on the study; 348 were treated.
748610|NCT00725725|Adult (18 to 65 years of age) male and female participants with a diagnosis of current panic disorder (PD; with or without agoraphobia [AGP]) were recruited.|
748611|NCT00725712|A total of 74 participants with Metastatic gastric cancer were enrolled in this sequential cohort study at 15 sites in the United States of America. The study was conducted from 23 March 2007 to 20 October 2009.|
748612|NCT00725621||
748613|NCT00725608|"Recruitment period: May 2008 - December 2009 Patients were eligible for observation if the transfer from an ongoing opioid dependence therapy to Suboxone was indicated and planned prior to enrollment to P05444 by the treating physician.
~Multiple sites in Austria: general practitioners, clinics/outpatient clinics, drug counseling centers, prisons"|339 patients were enrolled, 32 datasets were excluded from analysis because of missing baseline assessment and/or missing final/dropout documentation = 307 eligible datasets were used for final general and safety analysis
748614|NCT00725543||
748615|NCT00725530|Each site enrolled normal participants (non-depositors) and depositors in approximately a 1:1 ratio, as outlined in the protocol. 54 participants in 3 US sites and 1 UK site were enrolled.|Participants meeting eligibility criteria at the screening visit were enrolled into the study. 48 hours of no lens wear prior to Visit 1 served as the washout period. This reporting group includes all enrolled and dispensed participants.
748616|NCT00725504|71 patients were recruited through the Stanford University Pain Management Center.|Individuals were assessed for neuropathic pain prior to enrollment. Those with co-morbid cardiac disease were excluded from the study.
748617|NCT00725491||
748618|NCT00725452||
748619|NCT00725361||
748620|NCT00725322||84 total participants were enrolled. 46 were withdrawn before randomization due to failure at screening or following protocol. A total of 38 participants were randomized. A total of 30 participants remained for the first injection after 8 were withdrawn due to medication, surgery, or patient decision. A total of 27 participants completed the study.
748621|NCT00725296||A total of 178 participants were enrolled in this study. Of these, 159 participants were Infliximab-naive and 19 participants were already on Remicade (Infliximab). A total of 163 participants received at least one dose: 152 of the 159 naive participants and 11 of the 19 non-naive participants.
748622|NCT00725283||
748623|NCT00725270||
748624|NCT00725205||A total of 294 participants were enrolled, 2 participants were not treated.
748625|NCT00725153|55 Subjects currently wearing hydrogel or silicone hydrogel lenses were recruited at 3 US and 1 United Kingdom study sites.|Subjects randomized by lens order to wear PureVision and Acuvue 2 lenses for 10 hours each.
748626|NCT00725101||
748627|NCT00725075||Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received add-on therapy with MK-8435 (Org 25935). 215 participants were randomized and 214 participants were treated. There was no stratification for SGA treatment.
748628|NCT00725049|Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began February 2009 and ended February 2011. All study patients were enrolled at 3 European Universities (dental clinics).|
748629|NCT00725010||
748630|NCT00724984||
748631|NCT00724971||Six consecutive patients were enrolled as the first cohort. The dose and administration were considered to be reasonable if <=2 participants in the first cohort experienced a dose limiting toxicity (DLT), and an additional 4 subjects were to be enrolled as the expanded cohort for a total 10 participants.
748632|NCT00724958||
748633|NCT00724945||
748634|NCT00724932|Participants were recruited from 10 sites in Germany, Russia, Finland and the United Kingdom between July 2008 and March 2009.|
748635|NCT00724893||
748636|NCT00724867||Participants with systemic lupus erythematosus who completed the Phase 3 HGS1006-C1056 were enrolled to receive belimumab
748637|NCT00724854||
748638|NCT00724815|The study was initiated January 2009 and completed July 2009. Patients were enrolled from 38 investigative sites across the United States.|
748639|NCT00724750||
748640|NCT00724711|Participants were enrolled at a total of 76 study sites; 70 in the US, 3 in Canada, and 3 in Puerto Rico. The first participant was screened on 15 August 2008, and the last participant was randomized on 27 April 2010. Last participant observation (LPO) date was 19 April 2011|A total of 393 subjects were screened for entry into this study, and 312 subjects were randomized (156 to each treatment group). One participant randomized to the TVD+PI/r group was never treated.
748641|NCT00724698||
748642|NCT00724594||Due two enrolling two sets of twins (one set in the preterm/NAC group, and one set in the preterm/control group), our study included 24 infants and 22 mothers.
748643|NCT00724568||
748644|NCT00724503|Between 10 October 2006 and 26 April 2013, 561 patients were screened. 31 screen failures included 2 patients who were randomized twice. 530 patients were randomized in the Intent to treat (ITT) population from 87 centres in Australia, Europe including Belgium, France, Germany, Israel, Italy and Spain, New Zealand and the US.|
748645|NCT00724477||
748646|NCT00724464||401 participants were screened for eligibility. 332 participants were enrolled in the study.
748647|NCT00724451||
748648|NCT00724373||
748649|NCT00724347|VA patients with hearing loss who wore hearing aids (HAs) were recruited from the VA audiology clinic. Control subjects of similar ages as well as young control subjects were also recruited in order to characaterize speech discrimination capabilities in normal-hearing populations.|Most listeners with hearing loss were tested with and without their hearing aids prior to beginning 8 weeks of at-home PC training.
748650|NCT00724308||
748651|NCT00724282||Investigator left academia and is unavailable; participation in cross-over sequences was not unblinded, therefore participants are presented in one Arm throughout Results.
748652|NCT00724243||
748653|NCT00724152||
748654|NCT00724126||
748655|NCT00724061|"Study opened at Northwestern University in 09/2008 with an accrual goal of 15 subjects. The study was suspended from 11/2009 to 07/2010 due to a shortage of psoralens; a revision allowed the use of PUVA or NB-UVB for UV therapy.
~A total of 7 patients were enrolled before the study was closed due to poor accrual in 05/2012."|
748656|NCT00724009||
748657|NCT00723957||Of 260 participants enrolled, 197 were randomized. Among those randomized, 191 received treatment.
748658|NCT00723944|A minimum of 100 patients were enrolled across all participating centers, with enrollment beginning in January 2005. Enrollment period remained open until April 2006. Three participating sites were Universities and seven were private practices.|Pre-treatment included a screening visit (enroll those meeting all inclusion criteria), signing informed consent, and pre-surgical data collection.Patients returned for implant placement surgery, followed by temporary prosthesis placement at 2 months.
748659|NCT00723931||
748660|NCT00723892|614 participants were recruited in this study.|Only 568 participants were assigned to treatment as they were foreseen to complete treatment, were consulted, and met inclusion criteria.
748661|NCT00723840||
748662|NCT00723827||
748663|NCT00723801||
748664|NCT00723788|Patient referral from Emergency Department for suspected appendicitis with ultrasound and/or CT imaging request (0800 hr - 1700 hr) Patients accrued from Aug 2008 - Apr 2010|
748665|NCT00723749|Recruitment of sites: Jan - Dec 2008 (General Practitioners, Out-Patient-Clinics, Clinics) Recruitment of patients: Mar 2008 - Dec 2009|384 patients were enrolled, 39 datasets were excluded from analysis because 1) physicians withdraw participation agreement, 2) drop-out of patient or final documentation not available
748666|NCT00723736||
748667|NCT00723710||299 participants were enrolled. Of these, 294 were considered efficacy evaluable (5 participants were excluded from efficacy analyses: 2 moved, 1 required radiation, 1 not eligible and 1 missing data).
748668|NCT00723697||
748669|NCT00723645|Participants who had achieved a viral response prior to this study (negative for Hepatitis C Virus [HCV] ribonucleic acid [RNA] at the end of treatment as per product label) were recruited for follow-up on the present study.|A total of 279 participants enrolled in the study. Twenty-one participants failed screening and 258 participants were evaluable at Visit 1 (V1), which could be performed up to Week (Wk) 4 after the end of treatment.
748670|NCT00723632||
748671|NCT00723606||
748672|NCT00723580|A six year old child with Autism Spectrum Disorder (pervasive developmental disorder) and Kabuki Syndrome anticipating a pharmacological intervention was evaluated for sleep and behavioral disturbances. She was invited to participate, her parents provided consent and the child acknowledged her assent.|The child had previously not responded to multiple medication trials, was stimulated by diphenylhydramine, over-sedated on clonidine and had mood destabilization when tried on mirtazapine. The child received no medication for the month preceding the initiation of the study.
748673|NCT00723554|Patients were enrolled at 22 U.S. centers|Adults with pulmonary arterial hypertension (PAH) who were using Ventavis (Iloprost) Inhalation Solution Delivered by I-Neb Utilizing Power Disc-6 (PD-6) were enrolled
748674|NCT00723528||
748675|NCT00723489|From August 2008 to March 2011, three centers in the United States recruited participants ages 27 to 43 years who fulfilled eligibility criteria. Refer to the Eligibility Section for more details.|
748676|NCT00723450|A total of 301 participants were enrolled in the study, of which 298 subjects took at least one dose of lamotrigine (LTG). One hundred and seventy three participants met stabilization criteria and entered the Randomized Phase.|The study consisted of a 2-week Screening Phase, an 18-week Open-Label Phase, a 36-week Double-Blind Randomized Phase and a Taper and Follow-up Phase (up to 4 weeks depending on the dose the participant was taking at the last Open-Label or Randomized Phase visit), which was either open-label or double-blind depending on the phase of the study.
748677|NCT00723398||
748678|NCT00723294||
748679|NCT00723255|The study was activated on 9/8/2008 and closed to accrual on 3/22/2010 (and was suspended from 1/19/2009 to 12/7/2009).|
748680|NCT00723229|Participants were recruited between July 2008 and March 2010. Participants were enrolled at the University of Washington Virology Research Clinic, Seattle, WA.|
748681|NCT00723203||
748682|NCT00723190|This was a multicenter study conducted at 27 study centers in the United States. First subject visit was on January 09, 2008 and last subject completed the study on March 08, 2010|Candidates enrolled in this study (CLON-303) were subjects who completed studies using KAPVAY (CLONICEL) as add-on therapy with stimulants (CLON-302) and as monotherapy (CLON-301). There was no screening period for this study. The safety follow-up visit from these two prior studies (CLON-301 and CLON-302) was the baseline visit for current study
748683|NCT00723177||
748684|NCT00723125|DDAC: (dose-dense doxorubicin and cyclophosphamide (DDAC)|
748685|NCT00723099||
748686|NCT00723073||
748687|NCT00723021||
748688|NCT00723008|Military service members who received outpatient rehabilitation through the US Army Institute of Surgical research (USAISR) were enrolled September 12, 2007-January 9,2009.|
748689|NCT00722865||
748690|NCT00722800|Recruitment methods used were Craig's list, Metro and our hospitals email. All subjects were seen at MGH.|One subject was ineligible because she was taking ibuprofen regularly.
748691|NCT00722761||Females, age 18 to 45 years, who achieved spontaneous menarche and had a diagnosis of truncal acne of 10 to 50 inflammatory lesions on the back and chest combined with not more than 5 nodules
748692|NCT00722722||
748693|NCT00722566||
748694|NCT00722553|Patients were enrolled between July 2008 and November 2010 across 10 study sites and 5 countries.|
748695|NCT00722436||
748696|NCT00722423||
748697|NCT00722371||
748698|NCT00722137|A total of 487 participants were randomized from 128 centers in 28 countries from 22 May 2008 to 17 June 2017; 244 to the R-CHOP treatment group and 243 to the VcR-CAP treatment group. Of the 487 randomized participants, 242 in the R-CHOP group and 240 in the VcR-CAP group received at least 1 dose of study drug.|
748699|NCT00722124|Recruitment began on 10/07/08 and completed on 10/01/09. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, MN and Franciscan Skemp Medical Center in Lacrosse, WI) for consenting and additional study procedures to determine eligibility.|
748700|NCT00722111|PI is not available, thus the numbers presented are what was initially entered by research team. From data available, only two of the four treatment arms had subjects randomized to. Thus, for the other treatment arms, no data is available, as PI is not available.|
748701|NCT00722072||
748702|NCT00722020||
748703|NCT00722007|Between 24 Apr 2008 and 21 Dec 2011, 147 participants were enrolled in 6 study hospitals, with 160 Cormet resurfacing implants in 134 unilateral and 13 bilateral procedures.|
748704|NCT00721968||62 enrolled and 44 randomized. Therefore 18 subjects enrolled who either did not pass baseline visit or were not randomized to the trial.
748705|NCT00721955||
748706|NCT00721799||
748707|NCT00721734|This study enrolled patients with multiple myeloma (MM) who had relapsed or progressive disease (PD) after at least 1 (original protocol) or 2 (following protocol Amendment 1) prior therapeutic treatments or regimens. Five groups of MM patients, representing different levels of renal function, were evaluated.|
748708|NCT00721630|Protocol Open to Accrual 7/10/2008, Protocol Closed to Accrual 7/27/2010, Primary Completion Date 7/14/2016, Recruitment location is the medical clinic|
748709|NCT00721617|Subjects were recruited from Grady Memorial Hospital|All subjects had a 2-hour glucose of less than 200 mg/dL during a 75 g oral glucose tolerance test and a fasting glucose of less than 126 mg/dL.
748710|NCT00721578||
748711|NCT00721539|Patients recruited through tertiary care medical center specializing in head and neck cancer; enrollment dates 9/2010 to 9/2012.|Exclusion criteria include unexplained fever, active infection, pregnancy, anatomic parameters which preclude surgery including trismus, limited range of neck motion, poor dentition, and physical features such as redundant hypopharyngeal tissues which prevent adequate exposure of tumor.
748712|NCT00721513||
748714|NCT00721409|This Phase 1/2, open-label, randomized study enrolled a total of 12 participants at 3 sites in the United States for Phase 1. Phase 1 participants received Palbociclib + Letrozole. In Phase 2, a total of 165 participants were randomized (84 in palbociclib plus letrozole arm and 81 in letrozole alone arm) at 50 sites in 12 countries.|Phase 2 portion has 2 parts. Phase 2, Part 1 - ER positive, HER2 negative postmenopausal women with advanced breast cancer. Phase 2, Part 2- ER positive, HER2 negative postmenopausal women with tumors demonstrating CCND1 gene amplification and/or loss of CDKN2A gene.
748715|NCT00721396|Subjects were recruited from 4 centers in UK, 5 centers in Italy, 16 centers in Spain, 6 centers in Belgium, 25 centers in Germany and 4 centers in Czech Republic|All subjects enrolled were included in the trial.
748716|NCT00721357||
748717|NCT00721279||
748718|NCT00721253|"Subjects 18 years or older of either sex and any race; bilateral diagnosis of cataracts.
~There were no patients that received implantation of the Tecnis Multifocal lens."|Subject eligibility was determined at the pre-operative visit.
748719|NCT00721227|Enrollment period started April 17, 2008. Enrollment continued until December 31, 2008. The followup period continued until January 29, 2010. Enrollment was conducted in the bariatric and research offices of The Cleveland Clinic Foundation, Cleveland, Ohio.|
748720|NCT00721214|This study plans to accrue over one year with a planned 2 year subsequent follow-up. Virginia Commonwealth Unvierstiy (VCU) will be the sole site for this project.|
748721|NCT00721188|Recruitment period: January 2006 to July 2008 Location: Hospital|
748722|NCT00721175|Between November 2007 and March 2010, one hundred and eight patients who visited medical clinic at Srinagarind hospital, Khon Kaen University were randomized into the study|the patients were excluded from trial after enrollment if CBD canulation is failed.
748723|NCT00721162||73 participants signed informed consent.
748724|NCT00721149||
748725|NCT00721136||Two patients from each treatment arm were excluded from the analysis. Three of these patients withdrew after being told of the treatment assignment, and one patient's procedure was cancelled owing to need for a left ventricular assist device.
748726|NCT00721123||
748727|NCT00721110||This is a factorial study design with 64 patients randomized to 2 treatments each: lidocaine or placebo and ketamine or placebo. Each treatment was analyzed separately (i.e., lidocaine versus placebo and ketamine versus placebo separately). Though there are 4 distinct groups, the same 64 patients are in both lidocaine and ketamine analyses.
748728|NCT00720941|Per protocol amendment, the number of participants (par.) was increased to ~1100 (including all par. enrolled in Studies VEG108844 and VEG113078 [NCT01147822; a substudy in Asian par.]). This summary is a pooled analysis of both studies. 1110 par. were analyzed; 927 from VEG108844 (reflected in the protocol enrollment field), 183 from VEG113078.|Participants were stratified based on Karnofsky Performance Scale scores (70 or 80; 90 or 100), Baseline levels of lactate dehydrogenase (>1.5 versus <=1.5 times the upper limit of normal [ULN]), and previous nephrectomy (yes versus no) and were randomized in a 1:1 ratio to receive either pazopanib or sunitinib.
748729|NCT00720876||
748730|NCT00720798||
748731|NCT00720759|Subjects were recruited between 1/5/10 and 6/3/11. Recruitment sites included: 1) The VA Rehabilitation Research and Development Brain Rehabilitation Research Center of Excellence at the Malcom Randall VA Medical Center, Gainesville, Florida; and outpatient clinics of the Brooks Rehabilitation Hospital, Jacksonville, Florida.|All potential participants who met inclusion and exclusion criteria for the study and who provided informed consent were promptly randomized and entered into the study.
748732|NCT00720629|Participants were enrolled at Moffitt Cancer Center between February 2008 and April 2010.|The study was closed during the single-arm, first stage and did not proceed to the second stage comparison to antithymocyte globulin (ATG) in combination with tacrolimus/methotrexate as originally planned.
748733|NCT00720499||This was a randomised, 2-way cross-over trial. 141 patients were randomized to one of 2 treatments sequences and treated. It was a double-blind trial in which each treatment period lasted 4 weeks. During the 2 week pre-treatment run-in and during the 2 week washout between treatment periods, patients received open-label tiotropium 5µg.
748734|NCT00720473||
748735|NCT00720434||
748736|NCT00720382|First observation: 09 MAR 2007 Last observation: 20 JUN 2008|Subjects participated in a 7 day screening period to identify appropriate subjects based on symptom scores.
748737|NCT00720369|"Please note that subjects who sign the informed consent form are considered enrolled. Only subjects who met eligibility following screening are included in analyses and thus included in the participant flow. Of the 42 enrolled, 19 started the study and 18 completed."|
748738|NCT00720356|The study was ready for accrual March 12, 2009 with an accrual goal of up to 50 patients. The first patient was enrolled on July 7 2009. Accrual was suspended on July 29 2010 and reopened on March 30, 2011. The study was closed permanently on November 03, 2011 with an accrual of 48 patients treated on study after screening 115 patients.|Registration is a two step process. ICF signed, tissue sent off and MGMT promoter methylation status determined eligibility. Patients with unmethylated MGMT promoters will be complete the second registration step and be treated on study. Patients with methylated MGMT promoters will not be treated on study.
748739|NCT00720343|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2011.|
748740|NCT00720330||
748741|NCT00720278|First observation: 14 Aug 2007 Last observation: 19 Nov 2007|Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
748742|NCT00720226||
748743|NCT00720213|Participants were recruited from the investigators' sleep labs.|Participants were excluded if they did not demonstrate an Apnea-Hypopnea Index (AHI) ≥ 10 and Central Apnea Index (CAI)≥ 5 during the diagnostic polysomnography (PSG), or if they did not demonstrate a CAI ≥ 5 on continuous positive airway pressure (CPAP) titration.
748744|NCT00720122||
748745|NCT00720109||
748746|NCT00720096||
748747|NCT00720083||34 subjects were registered, after which 2 did not continue to randomization due to physician preference.
748748|NCT00720057||The Screening Period occurred up to 28 days prior to the day of dental surgery. A total of 447 subjects were screened, of which 135 were excluded (72 did not meet inclusion criteria, 19 refused to participate, 44 other reasons); 312 subjects were randomized and included in the intent-to-treat (ITT) population for efficacy and safety analysis.
748749|NCT00719953|Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.|
748750|NCT00719914||
748751|NCT00719901|Participants were recruited from 5 medical clinics in the United States between February 2008 and January 2011.|This was a phase I/II trial. A total of 11 participants were accrued, all to the phase I portion. This trial was terminated due to slow accrual and the drug supply of Obatoclax during the phase I; therefore, the phase II portion will never open. No results from the phase II portion are available.
748752|NCT00719862|First observation: August 20, 2007 Last observation: November 14, 2007|Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
748753|NCT00719849||
748754|NCT00719810|This study targeted participants with complicated skin and skin structure infections (cSSSI), i.e. infections involving subcutaneous tissues or requiring surgical intervention. Patients could have one of three infection types: wound infection, abscess, or cellulitis.|
748755|NCT00719732|Subjects 18 - 70 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.|Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
748756|NCT00719706|Recruitment began in August 2008 and ended in May 2011 and took place at a research lab within McLean hospital.|To limit heterogeneity in the imaging sample, we accepted only type I bipolar disorder participants for the imaging component of the study.
748757|NCT00719680||
748758|NCT00719615|Individuals (at University of Nebraska Medical Center)were selected from a thyroid tumor and cancer collaborative registry (TCCR), database & biospecimen bank, started March 2008. We achieved a sample size of 111 subjects with 24 patients with active thyroid cancer, 45 patients with thyroid cancer in remission and 42 patients with thyroid nodules.|Individuals who had agreed to participate in the TCCR and who had also given a blood sample were included in sequential order.
748759|NCT00719576||
748760|NCT00719563|Three-hundred and sixty-four participants were recruited between October 2008 and July 2011 from 40 North Central Cancer Treatment Group (NCCTG) member sites.|There were a total of 23 cancellations (12 Ginseng, 11 Placebo) and these 23 patients were excluded from all analysis.
748761|NCT00719537||
748762|NCT00719472||Of 451 enrolled patients, 26 withdrew before receiving treatment and are not included in the Baseline Characteristics nor any of the Outcome Measures.
748763|NCT00719355|Patients were recruited at University of Illinois at Chicago, the Edward Hines Jr., VA Hospital, through radio and print advertising. 146 patients were enrolled in the study and 103 were randomized.|Patients were screened prior to randomization. Patients were disqualified from the study due to coronary arterial disease, they changed their mind, other medical reasons or it was found that they did not have periphaeral arterial disease.
748764|NCT00719329|All babies recruited between September 2008 and September 2009|Babies were allocated based on their cluster allocation (i.e. location of birth) in the parent trial
748765|NCT00719264||
748766|NCT00719212|The study was conducted over a total of 35 sites in 7 countries.|
748767|NCT00719186||
748768|NCT00719160|12 healthy women and men enrolled|Participants received either Esomeprazole or placebo first and then crossed over to receive the other intervention with a minimum 2 week washout in-between.
748769|NCT00719134|Of 98 persons pre-screened for eligibility between December 2008 and March 2010, 19 were excluded and 3 declined to participate. The remaining 76 persons signed the consent form, but 10 of them dropped out of the study for various reasons. Participants were recruited from Beth Israel Deaconess Medical Center outpatient clinics.|Reasons for excluding 19 of the pre-screened subjects include chronic migraine, chronic daily headache, tension type headache, fibromyalgia, daily use of opioids, and medication overuse headache. We randomized participants to one of 8 treatment sequences and each patient received 3 treatments with Maxalt and 3 treatments with Placebo.
748770|NCT00719043|Study duration was of approximately 909 days for all subjects.|
748771|NCT00718887||A total of 228 participants were enrolled, of which 169 were randomized. A total of 166 participants received treatment.
748772|NCT00718861||
748773|NCT00718809|This protocol was based on getting at least 12 eligible patients with thymoma to complete stage one. There are 12 eligible thymoma patients and also 9 thymic carcinoma patients. Since no patients in the thymoma group had a response of Complete or Partial response, the study ended without going to stage two.|
748774|NCT00718770|Patients were recruited from a medical clinic from 01/15/2009 to 01/14/2010|The patients must fit all inclusion criteria and have had a 4 week washout from any systemic or radiation therapy. As an open-label, single arm trial, there was no group assignment. Patients were excluded only if they did not meet inclusion or had exclusion criteria
748775|NCT00718718||
748776|NCT00718666|Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.|Out of 387 subjects originally enrolled in the study, only 248 subjects received vaccination.
748777|NCT00718640||
748778|NCT00718549||A total 136 participants were screened, out of which 128 participants were enrolled in this study.
748779|NCT00718523|The study was conducted over a total of 55 sites in 8 countries.|
748780|NCT00718510||
748781|NCT00718419||
748782|NCT00718328|Recruitment period October 2008- June 2009, Inpatient (ICU)|No issues prior to assignment
748783|NCT00718315||
748784|NCT00718302||249 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 233 subjects entered the flow.
748785|NCT00718237|The study was conducted at 32 sites in Japan from 2008 to 2009.|"Excluded from the trial before assignment to groups were subjects with: history of congenital abdominal
~disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea,
~or failure to thrive; immune impairment or resides in a household with an individual with an immune impairment."
748786|NCT00718159||The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment. All participants who received at least 1 dose of study drug were considered to have completed the study.
748787|NCT00718120||
748788|NCT00718094||
748789|NCT00718081||
748790|NCT00718042|US blood donors specimens collected as part of routine blood donation (Specificity: 16313, Extended: 25549). Additional specimens included: 204 T cruzi antibody positive US blood donor; 110 parasite positive, 85 antibody positive, 525 Chagas endemic; and 330 unidentified US blood donor presumed T cruzi antibody negative were provided by Abbott.|"All subjects were assigned to one group and tested with the PRISM Chagas assay. There were no pre-screening criteria.
~Specimens repeatedly reactive with the screening assay were further evaluated with ESA Chagas.
~The 330 unidentified US blood donor specimens presumed T cruzi antibody negative were only tested with ESA Chagas."
748791|NCT00717977|The study was conducted at 10 adult and pediatric diabetes centers, after approval by their institutional review boards. Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an individual with type 1 diabetes.|
748792|NCT00717912||
748793|NCT00717886||
748794|NCT00717873||
748795|NCT00717860||
748796|NCT00717756||
748797|NCT00717626||
748798|NCT00717574|Study includes patients aged 18 to 55 years who were classified as ASA physical status ≤2 and scheduled to have surgery under general anesthesia . Only patients for which intraoperative Entropy or BIS monitoring was planned were enrolled by speaking to the attending anesthesiologists working at the OU Presbyterian hospital.|Patients were randomized into 2 groups that differ in the choice of the agent for the maintenance of general anesthesia: sevoflurane or propofol.
748799|NCT00717522||
748800|NCT00717418||Treatment for this study was per normal clinical practice and not assigned.
748801|NCT00717405||
748802|NCT00717366||A total of 112 participants were screened at 28 sites in 10 countries, of which 64 participants were enrolled (16 initially in MIRCERA Group 1 and then 48 in MIRCERA Group 2, following a preliminary analysis of MIRCERA Group 1).
748803|NCT00717314||
748804|NCT00717288||
748805|NCT00717275|Participants were recruited from the investigator's clinical practice between September 2008 and January 2011.|
748806|NCT00717249||A total of 529 subjects were enrolled in this study. Of those enrolled subjects, 33 did not meet the eligibility criteria and 496 were randomized to either the test or control lens using a 2:1 allocation. Of those randomized subjects 491 were successfully dispensed. Of the dispensed subjects 454 subjects completed the study.
748807|NCT00717236|The study started in July 2008 with subjects from the United States, Canada, France, Germany, Italy, the Netherlands, and Spain. The primary completion date occurred in March 2010, with study completion in March 2011.|Of the 1648 subjects that were screened, 585 subjects had screen failures. Therefore, 1063 subjects were randomized in this study.
748808|NCT00717197|Participants were recruited from the investigator's clinical practice from October 2008 thru June 2011.|30 participants were enrolled in the study. 7 were excluded from participation prior to group assignment [5 were unable to purchase study drug; 1 had rapid tumor growth; and, 1 was withdrawn by the investigator for mental health reasons].
748809|NCT00717093||
748810|NCT00717067|Two centers took part in this study between 15 July 2008 and 21 November 2008.|Subjects were enrolled into treatment groups (healthy subjects, mild, moderate, severe renal impairment, or end stage renal impairment on hemodialysis) based on creatinine clearance results obtained closest to the dosing date at screening as determined by the Cockcroft-Gault equation (with the exception of subjects undergoing hemodialysis).
748811|NCT00717054||
748812|NCT00717041||
748813|NCT00716976||
748814|NCT00716963||
748815|NCT00716859||Randomization was stratified by age, diagnosis (congenital glaucoma [PCG] or non-congenital glaucoma [non-PCG], and intraocular pressure [IOP]) of the study eye at baseline.
748816|NCT00716820||
748817|NCT00716807|Recruitment details unavailable due to death of investigator|pre-assignment details unavailable due to death of investigator
748818|NCT00716742||
748819|NCT00716625||
748820|NCT00716482|Recruitment dates: October 23, 2008 - June 15, 2010 Hospitals and private medical clinics in 16 sites worldwide participated.|
748821|NCT00716456|"Protocol Open to Accrual: 7/15/2008
~Protocol Closed to Accrual: 5/25/2010
~Primary Completion Date: 5/24/2011
~Recruitment Location is the Medical Clinic"|
748822|NCT00716443|Dates of recruitment period: First subject was enrolled on July 30, 2008 and the last subject was enrolled on September 8, 2008.|The wash-out period prior to baseline was 24 hrs for analgesic medication; 14 days for aspirin (ASA), non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants, St. John's Wort or doses of Vitamin E above the recommended daily allowance; 14 days for sunburn/tanning bed exposure; 12 months for filler injections into the nasolabial folds.
748823|NCT00716417||
748824|NCT00716274||Participants were randomized to either atomoxetine or placebo during study period II. Placebo participants were then assigned to atomoxetine in study period III. Atomoxetine participants were re-randomized to atomoxetine or placebo in study period III. Participants assigned to the healthy control group did not receive any study drug.
748825|NCT00716144|A total of 176 participants were randomized into the study. This study was conducted at 25 centers located in Ireland, the United Kingdom, the Netherlands, Germany, and Russia from 19 June 2006 to 18 May 2007.|All participants were screened (Visit 1) two weeks prior to randomization (Visit 2) in order to evaluate their eligibility for entry into the trial. At Visit 1, participants signed an informed consent, provided their medical histories, reported their concomitant medication usages, and were evaluated against the inclusion/exclusion criteria.
748826|NCT00716092||
748827|NCT00716079||
748870|NCT00713661||"Subjects were divided into
~Surgery method: open or laparoscopic
~Location of the anastomosis:
~anastomotic line in the low segment (approx. 0-5 cm from the anal verge)
~anastomotic line in the mid or upper segment (approx. 5-12 cm from the anal verge)"
749764|NCT00671437|Recruitment was open from 06/03/08-10/17/11 at the Siteman Cancer Center (a medical clinic).|
749765|NCT00671177||
748828|NCT00715962|Participants were patients 65 years or older admitted to the medical wards of the Birmingham Veterans Affairs Medical Center from January 12, 2010 to June 29, 2011.|Inclusion criteria were: having a negative screen for cognitive impairment (Mini Cog score ≥ 3), not being delirious (CAM score=0), self-report of being ambulatory with or without an assistive device in the 2 weeks before admission, not having a significant language barrier requiring a translator, and not previously enrolled in the study.
748829|NCT00715949||
748830|NCT00715910|At Year 5, subjects in Nimenrix 1, Menactra and Nimenrix 2 groups received a booster dose of Nimenrix. During booster phase, subjects in Nimenrix 1 and Nimenrix 2 groups were pooled. An additional naïve control group 15 to < 31 years of age was enrolled at Year 5.|A total of 818 subjects were enrolled in the study. Year 1, 3 and 5 included only those subjects who came for the visits during these persistence years.
748831|NCT00715884||
748832|NCT00715793||
748833|NCT00715754||
748834|NCT00715741|Recruitment started 06/24/2008 and ended 07/07/2009. Subjects were recruited via the Operating room schedule|
748835|NCT00715728||
748836|NCT00715676|Subjects were enrolled from 5 March 2007 to 19 December 2007 at 9 centers within the United States.|
748837|NCT00715650|Participants were recruited from December 2008 to December 2011. Veterans were eligible for participation if they were seeking service-connection for a psychiatric disability and they indicated that emotional problems had interfered with work in the past 28 days.|
748838|NCT00715624|The study was conducted at 111 centers in 15 countries between July 29, 2008 and February 8, 2011. The overall duration of treatment was at least 76 weeks (24 weeks main double-blind treatment; variable double-blind extension treatment).|A total of 879 patients were screened of which 383 (43.6%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 496 patients were randomized.
748839|NCT00715559|A total of 3 participants were recruited between June 2007 and May 2009.|Participants with major depression were enrolled if they had previously failed to respond to at least one FDA-approved antidepressant. There are no prospective treatment or lead-in and the study was conducted open-label.
748840|NCT00715520|Participants were recruited between April 2007 and August 2013.|
748841|NCT00715429||15 participants got excluded from the study due to not fulfilling the inclusion criteria.
748842|NCT00715403|This was a multinational, open-label, uncontrolled, extension trial with Nintedanib in patients who had experienced a clinical benefit with Nintedanib (objective tumour response or disease stabilisation and/or symptom improvement) in either one out of five phase I or phase I/IIA clinical trials for advanced solid tumours at study entry.|
748843|NCT00715390|We performed a retrospective chart review of anesthetics administered at The Children's Hospital of Philadelphia from July 1998 through July 2004.|Excluded were patients with known arrhythmias or pro-arrhythmic conditions, patients with congenital heart disease and patients undergoing cardiac surgery or cardiac catheterization.
748844|NCT00715299||
748845|NCT00715208||
748846|NCT00715117|14 subjects were enrolled in this pilot trial and 2 were screen failures and not randomized or treated|The 2 subjects who were screen failures had PCDAI scores less than 30.
748847|NCT00715104|The study was conducted across 6 sites in the US. Screening and enrollment occurred from Sept 2008 - Dec 2012. 42 subjects were registered. 41 subjects received at least 1 sipuleucel-T infusion prior to radical prostatectomr (RP),18 subjects were randomized to the booster group,15 were randomized to the no booster group; and 8 were not randomized.|
748848|NCT00715078||
748849|NCT00715026||
748850|NCT00714948|Protocol Open to Accrual: 07/10/2008 Protocol Closed to Accrual:12/08/2009 Primary Completion Date: 11/22/2011 Recruitment Location is the medical clinic|
748851|NCT00714870|Participants with BMI % greater than or equal to 85% ages 9-20 were recruited from providers' offices between 2008-2012|Participants with endocrinologic conditions associated with weight gain were excluded from enrollment
748852|NCT00714792||
748853|NCT00714753||
748854|NCT00714714||
748855|NCT00714688|This study was conducted from 4 February 2008 (first subject in) to 2 April 2009 (last subject out).|After enrolment patients entered a screening period of up to 2 weeks included the tapering and discontinuation of current forbidden treatment (except if fluoxetine or Monoamine Oxidase (MAO) inhibitors needed to be tapered, in which case a screening period of 4 weeks was allowed).
748856|NCT00714571||
748857|NCT00714493||
748858|NCT00714415||
748859|NCT00714389|Urogynecology and OBGYN clinic March 2008|
748860|NCT00714311||
748861|NCT00714285||
748862|NCT00714272||
748863|NCT00714259||
748864|NCT00714233||
748865|NCT00714168|Recruitment included television and newspaper advertisements. Participants were enrolled between May 2008 and February 2010 at 2 clinical sites: 1) University of Pittsburgh, 2) University of North Carolina - Chapel Hill.|433 individuals attended an orientation and provided written informed consent. Of these, 70 did not schedule a baseline assessment, failed to show for a baseline assessment, or were found to be ineligible after written consent was obtain. Thus, 363 were randomized to participate in this study.
748866|NCT00714051|Patients were recruited from the general medical clinics, nuclear medicine department and electronic medical record. Letters of invitation were sent to eligible participants. Recruitment began in January 2009 and ended in August 2011. .|92 participants were screened for eligibility in the study. 55 participants were randomized and 37 were not randomized. Reasons for not being randomized are: 13 = bone mineral density of less than .65 gm/cm2; 11 =could not meet time commitments of study; 3=orthopedic problems; 10=other reasons
748867|NCT00713830|The study was conducted at 136 centers in 16 countries between July 08, 2008 and January 14, 2011. The overall duration of treatment was at least 76 weeks (24 weeks main double-blind treatment; variable double-blind extension treatment).|A total of 1438 participants were screened of which 579 (40.3%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 859 participants were randomized.
748868|NCT00713817||
748869|NCT00713700||
748871|NCT00713648|Of a total of 29 initiated trial sites, 23 sites enrolled and dosed at least one patient. The country distribution was (number of actively recruiting sites per country in parenthesis): Austria (1), Canada (1), Finland (1), France (1), Germany (3), Israel (2), Italy (1), Spain (1), Switzerland (1), UK (3) and United States of America (8)|After screening, eligible subjects entered a 4-week run-in period followed by a 52-week recombinant factor XIII (rFXIII) treatment period. Subjects who before entering the trial were receiving regular replacement therapy with a FXIII-containing product were to receive their last standard replacement dose just before the screening visit.
748872|NCT00713609|In this multi-center, double-blind, vehicle controlled study, participants were assigned to one of the six treatment groups in a 2:2:2:2:2:1 ratio for 12 weeks.|Participants with facial acne vulgaris, 12 to 45 years of age were enrolled in this study. A total of 596 participants were randomized and 587 participants received study product.
748873|NCT00713596|Patients presenting for septorhinoplasty at the Mayo Clinic, Rochester, MN were offered the opportunity to participate in the study.|
748874|NCT00713583||
748875|NCT00713544|The first participant enrolled on 01 July 2008, and the last participant completed the study on 08 April 2009. Participants were recruited from 61 centres in 14 countries in Europe, Southern Africa and South America.|"Male or female adult patients with active rheumatoid arthritis (on background treatment of methotrexate) were randomly assigned to receive AZD5672 at 20, 50, 100 or 150 mg once daily, placebo or etanercept.
~It was planned to randomise approx 360 patients in total, 60 to the open-label etanercept arm and 300 in total to the AZD5672 or placebo arms."
748876|NCT00713479|Subject were recruited from local advertisements for non-treatment seeking methamphetamine users in 2008.|Participants had 30 days in which to complete all eligibility procedures. Volunteers were: MA dependent who were not seeking treatment;nicotine dependent (smoking 10+ cigarettes/day);reported using MA via smoking or IV;could not have significant medical illnesses;be taking psychotropic medications or dependence criteria for other substances.
748877|NCT00713349|Healthy adult volunteers, 18 years of age and older|Each subject acting as their own control
748878|NCT00713323||
748879|NCT00713310|Recruitment began 16 Dec 2008|
748880|NCT00713284||
748881|NCT00713258||
748882|NCT00713219||
748883|NCT00713206|Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began September 2006 and ended May 2008.|
748884|NCT00712985|Recruitment period was from 1/10/2007 for first patient consented to 12/29/2009 last patient consented. The patients were all seen in the Milton S. Hershey Medical Center Oncology clinic & were treated from first patient Day 1 of 1/16/2007 to last patient month 12 of 2/01/2011.|Following consent, this trial only had 1 arm & all patients were given a one time dose of Zoledronic Acid 5 mg IV. All 17 patients were then followed for 12 months from day 1 & their urine & serum were collected in order to evaluate the urine N-telopeptide (NTx) & serum NTx & C-telopeptide (CTx) levels.
748885|NCT00712959|Participants were enrolled from 26 June 2008 to 27 February 2009 at 7 medical centers in Canada.|A total of 769 participants who met the inclusion and exclusion criteria were enrolled, 768 were vaccinated and evaluated.
748886|NCT00712933|This was a multi-center, continuation trial of belimumab and was conducted at 115 centers in 28 countries. Participants with Systemic Lupus Erythematosus (SLE), who had completed the Phase 3 HGS1006-C1056 or HGS1006-C1057 trial or participants who had previously received subcutaneous belimumab in Protocol HGS1006-C1070 were included in this trial.|738 participants were enrolled in the study and 735 received at least one dose of belimumab.Out of 735 participants, 368 completed the study and 370 withdrew from the study.
748887|NCT00712920|First Observation: February 5, 2007 Last Observation: October 8, 2007|Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.
748888|NCT00712725|Participants were recruited from 47 neurological and general research centers worldwide (19 in the United States and 28 internationally). The primary therapy period was between 2-Jul-08 to 16-Jan-09.|Participants were assessed using the protocol inclusion and exclusion criteria at Visit 1 and, if eligible, were randomized at the same visit.
748889|NCT00712673|The study was conducted at 133 centers in 16 countries between June 30, 2008 and March 09, 2011. The overall duration of treatment was at least 76 weeks (24 weeks main double-blind treatment; variable double-blind extension treatment).|A total of 1374 patients were screened of which 694 (50.5%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 680 patients were randomized.
748890|NCT00712543|Participants recruited from the outpaient clinics of Wake Research Associates (Raleigh, NC); Rapid Medical Research (Cleveland, OH) and Arya Gastroenterology (Brooklyn, NY) between June 2009 and August 2009.|
748891|NCT00712530|Nine subjects were sequentially enrolled into each cohort. Participants were recruited from the Szent László Hospital, Budapest, Hungary.|The first three subjects received a single low-dose DermaVir immunization. Further enrolment of subjects into the medium and high dose cohorts began only after the safety data for cohorts low and medium doses, respectively were available, and the criteria for enrolling into the next cohort were met.
748892|NCT00712348||
748893|NCT00712335|Recruitment period: January 2008-April 2011 Recruitment location: Asthma and Allergy Center, Inje University Sanggye Paik Hospital|After randomization, a 10-day washout period followed in which subjects were taken off all medications except albuterol metered dose inhaler as needed. After the washout period, baseline induced sputum was obtained in each group along with primary and secondary endpoints. This was followed by a 3-week run in period.
748894|NCT00712296|"Recruitment Period: 10/5/2006-3/12/2010
~Location: Mount Sinai School of Medicine, New York, NY
~Phase I Participants Screened 55 Consented 35 Excluded 13 Withdrawn 2
~Phase II Participants Screened 183 Consented 76 Excluded 19 Screen failed 11"|Phase I: Time frame 1 week; Phase II: Time frame 28 weeks. Participants from Phase I were invited to participate in Phase II and were re-randomized to all three arms of Phase II.
748895|NCT00712270||
748969|NCT00708877|Huntsman Cancer Institute recruited eligible participants between March 2007 and June 2011.|
748970|NCT00708851||
748971|NCT00708734||
748972|NCT00708721||
748973|NCT00708708||A total of 955 participants were enrolled for documentation. Of these 955 participants enrolled, only 926 participants were included in analysis.
748896|NCT00712244|Subjects were >50 years old & of any race & gender. Subjects had operable cataracts in at least 1 eye, were able to provide informed consent, & were free of systemic diseases affecting ocular health, especially those affecting endothelial cell counts. Eyes were free of ocular disease & had no history of chronic/recurrent inflammatory eye disease.|During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. Group assignment was based on an Excel randomization scheme.
748897|NCT00712179||
748898|NCT00712166|Participants were randomized at 39 sites in total: 34 in the United States, 1 in Canada, and 4 in Australia. Date of first screening was 16 June 2008, and date of last participant observation was 19 June 2009.|Planned trial size was approximately 140 participants randomized in 1:1 ratio to aztreonam for inhalation solution (AZLI) three times daily (TID) or placebo TID. 160 participants were randomized, 157 received blinded study drug (76 AZLI; 81 placebo). One participant who was randomized and treated with study drug discontinued the study.
748899|NCT00712075|Participants included 77 community dwelling Veterans and non-Veterans. Inclusion criteria: diagnosis of schizophrenia or schizoaffective, age 45 or older, fluency in English, and medical, psychiatric and substance abuse sufficiently stable for outpatient group therapy Exclusion criteria: prior exposure to CBT during the previous five years.|107 participants were enrolled in the study and 77 participants started the study. 30 were excluded (lost interest, N=6; Wrong diagnosis, N=10; Early study termination, N=4; Medically unstable, N=2; Psychiatrically unstable, N=4; Prior CBT, N=4).
748900|NCT00712010|Participants were recruited among the Nestlé Research Center staff from June 2008 to May 2009|25 healthy males were recruited; All presented all the inclusion criteria and none of the exclusion criteria listed in the protocol. The day before each test meal, the volunteers were recommended to eat normally as well as to conduct a normal physical activity. A standardized dinner was provided the night before testing.
748901|NCT00711997|First subject enrolled: 26 Oct 2009 Last subject completed: 7 Oct 2010 at 4 medical centers in Israel an 1 in US|Of the 16 patients screened, 7 were screening failures due to metastatic disease
748902|NCT00711971||
748903|NCT00711958|23 cancer centers, in Germany and Romania .|2:1 randomization All 114 patients found eligible were randomized and treated (60 in Germany and 54 in Romania)
748904|NCT00711880||
748905|NCT00711867|Patients were recruited sequentially and assigned to vitalHeat2 (VH2) or Bair Hugger temperature management at random in a 1:1 ratio.|75 consented. 9 cancelled surgery or were rescheduled. 36 assigned to VH2 and 30 assigned to Bair Hugger. 6 excluded from VH2 group after randomization (2 vacuum not established, 2 research staff not available, 2 arterial line used). 5 excluded from Bair Hugger group after randomization (4 laryngeal mask airway used, 1 epidural anesthesia used).
748906|NCT00711828||
748907|NCT00711802||
748908|NCT00711711|Patients from the Department of Orthopedic and Traumatic Surgery of the University Hospital of Lausanne were recruited from July 1, 2008 to November 16, 2010|
748909|NCT00711646||
748910|NCT00711594||
748911|NCT00711555||
748912|NCT00711529|Between September 2008 and September 2010, 73 women were screened for this study. Fourteen women were deemed ineligible and 32 decided not to participate. A total of 27 women were randomized to receive treatment, 14 to gabapentin and 13 to hypnotherapy.|
748913|NCT00711516||
748914|NCT00711490||
748915|NCT00711477||
748916|NCT00711464||
748917|NCT00711425||
748918|NCT00711412|The study opened for accrual on May 31, 2006 with an accrual goal of up to 43 patients. The study was designed to enroll 13 patients initially and do an interim efficacy assessment. Accrual was suspended on July 17, 2008 for this analysis and reopened on August 12, 2008. The study was closed permanently on february 24, 2009.|
748919|NCT00711347|Patients were scheduled for routine, primary, bilateral cataract extraction with subsequent insertion of an intraocular lens implant and demonstrating miotic/small pupils or intraoperative floppy iris syndrome. Additionally patients were free of ocular co-morbidities that may affect results.|During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. Patients were randomized (Excel based schedule) based on enrollment order.
748920|NCT00711269||
748921|NCT00711243|The study opened for accrual on March 3, 2005 and the first patient was enrolled April 20 2005. Accrual goal of approximately 50 for the phase I and phase II portion. Accrual for phase I was suspended on February 13 2006 reopened with phase II accrual on February 16, 2006. The study was closed permanently on July 23, 2008.|Phase I was opened to all solid tumor cancers and phase II was opened to stomach/gastro-esophageal junction cancer only.
748922|NCT00711191||
748923|NCT00711113||
748924|NCT00711100|Subjects were recruited 10/2008 through 8/2009 through local advertisements in Minnesota and Oregon.|Sampling Phase preceded the 2 week Abstinence Phase. Sampling phase involved sampling each study product for a 1/2 day; subjects then chose the product that they would like to use for a two week cigarette abstinence period
748925|NCT00711087||
748926|NCT00711022||
748927|NCT00711009||3 additional participants were randomized but did not receive study drug and therefore were not included in the analyses.
748928|NCT00710996|Patients with existing bilateral intraocular lenses (IOLs) of given type, age-matched patients with normal vision and no cataract surgery.|Subjects eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
748929|NCT00710970|Patients presenting to the Scott Department of Urology for management of recurrent bladder cancer and fulfill the following criteria will be recruited.|
748930|NCT00710944||
748931|NCT00710931||
748932|NCT00710905|Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.|
748974|NCT00708682||
748975|NCT00708643||
748933|NCT00710879|First participant was enrolled in this study on 07/07/2008 and last subject exited on 02/02/2009. 180 participants were enrolled at 9 investigative sites in the United States.|This study focused on participants of Japanese descent (at least one grandparent born in Japan) for a minimum of 20% of total enrollment. 180 participants were enrolled, 3 participants were ineligible at screening, 177 participants were eligible at the start of the study.
748934|NCT00710866||
748935|NCT00710840||
748936|NCT00710814||
748937|NCT00710762||89 patients were enrolled and 84 patients were randomised for this study.
748938|NCT00710749||
748939|NCT00710684|A total of 684 participants were randomized from 100 centers i.e. Australia, Argentina, Chile, Canada, United States of America, Czech Republic, Spain, Italy, Germany between 01 July 2008 and 16 November 2010.|Out of 1132 participants screened, 725 entered into 4-week placebo run-in period out of which 41 participants were placebo run-in failures. Out of 684 participants randomized, 682 were included in safety population (1 participant each from Donepezil+Placebo and Donepezil+SB742457 35 milligram [mg] group failed to take a dose of study medication).
748940|NCT00710606|Subjects were enrolled during the months of June-September 2008.|
748941|NCT00710593|Participants were enrolled between 2008 and 2011 at Adolescent Trials Network for HIV/AIDS Interventions (ATN) clinical sites.|
748942|NCT00710554||
748943|NCT00710424||
748944|NCT00710385|Enrollment dates: September 10, 2007 - August 13, 2008 Location: Medical clinic|
748945|NCT00710203||
748946|NCT00710034|Cigarette smokers interested in completely switching to snus or nicotine gum were recruited from Minneapolis/St Paul, Minnesota, and Eugene, Oregon.|
748947|NCT00710021||
748948|NCT00709995||Part 1 completers finished 3 or more cycles and included those with progressive disease. Part 2 was not performed and was not activated due to sponsor broad decision to not pursue enzastaurin in solid tumors.
748949|NCT00709956|On Day 1 all patients received a single inhalation dose of placebo. Patients who satisfied the selection criteria in the single-blind period of the study were entered into the double-blind period to receive iloprost 5 μg and matching placebo (Days 2 and 3) in a single dose, two-period crossover design.|Of the 70 randomized patients, 64 patients entered the double-blind period, (placebo/iloprost P15, 33 patients and iloprost P15/placebo, 31 patients). 1 patient in the iloprost P15/placebo treatment sequence was excluded from the per-protocol analysis which was defined as the primary analysis.
748950|NCT00709891||Participants who had not met the study primary clinical endpoint of ≥ CIN2 were invited to participate in the longitudinal follow-up phase.
748951|NCT00709878|A total of 8 samples per patient/inhibitor were collected, with a total of 32 patient specimens analyzed for this study.|
748952|NCT00709852|The date of the first participant's first visit was 11 JUN 2008. The date of the last participant's last visit was 03 APR 2009.|A total of 419 participants (part.) were screened; 17 prematurely discontinued prior to receiving any study drug. A total of 402 part. received study drug; 228 in gadobutrol : gadoteridol treatment sequence, 174 in gadoteridol : gadobutrol treatment sequence. Safety analysis set=402; gadobutrol=399, gadoteridol=393. Full analysis set (FAS)=336.
748953|NCT00709826|Study opened to accrual in August 2008. Enrollment closed on November 2010. One hundred and nine patients were randomized. Patients were recruited from clinical oncology practices.|
748954|NCT00709761|Summary of subject disposition table is on the intent-to-treat (ITT) population. The ITT population comprised of all subjects who received at least 1 dose of investigational product. The ITT population, which is the same as the actually treated population, is used for all the analyses of EOS reporting.|A safety cohort was designed into the study to include the first 10 participants enrolled. Enrollment was halted after the enrollment of the fifth participant to allow for the safety review. Enrollment was resumed after the review and protocol amended.
748955|NCT00709735||
748956|NCT00709722|The study was conducted at 6 sites in Germany and Czech Republic from 2003 to 2007|
748957|NCT00709696||
748958|NCT00709618||
748959|NCT00709592|Consecutive patients enrolled have recurrent or high-risk hematologic malignancy, adequate end-organ function and performance status. Patient required to have 7/8 or 8/8 mismatched related donor (MRD) or unrelated donor (URD), with high-resolution typing performed for HLA-A, -B, -C, and -DRB1.|Randomized to rabbit ATG (Thymoglobulin; Genzyme, Cambridge, MA), 2.5 or 1.7 mg/kg adjusted ideal body weight/day, followed by TBI to a total dose of 4.5 Gy. Methylprednisolone 2 mg/kg given pre-medication for ATG. GVHD prophylaxis was tacrolimus starting at approximately 12 weeks post transplantation.
748960|NCT00709319||
748961|NCT00709306||Participants were consented, baselined, and randomized upon arrival to the in-person session, thus no enrolled participants were excluded from the study before assignment to one of the four treatment conditions.
748962|NCT00709228||
748963|NCT00709202||48 subjects signed consent for the study. 8 subjects withdrew consent before randomization and another subject withdrew before the first post-baseline measurement. Therefore, only 39 subjects were analyzed.
748964|NCT00709124|3 medical and surgical ICUs at Johns Hopkins Hospitals screened for recruitment from 2008-2009 and 2010-2013 (39 months in total). Recruitment suspended for 17 consecutive months between 2009-2010 due to lack of staffing|2 patients (both randomized to the intervention group) were withdrawn PRIOR to any initiation of intervention due to new data arising after randomization (and before intervention initiation) that indicated the subject met the pre-existing exclusion criteria.
748965|NCT00709111|Recruited at 29 AIDS Clinical Trials Units in the United States between January 14, 2009 and May 4, 2009|34 enrolled
748966|NCT00709098|The double-blind period of the study was conducted at 20 centers in the US and Germany, and the following open-label period of the study was conducted at 17 centers in the US only. First patient, first visit was 4 September 2008 and the last patient, last visit was 17 June 2010.|Out of the 63 patients who completed the core study of AC-063A301, 49 gave informed consent and enrolled into this extension study.
748967|NCT00709059||
748968|NCT00708942|All subjects recruited from medical clinics/hospitals. Start of recruitment arms 1-3: Jan 2009 End of recruitment arms 1-3: Feb 2010 Start of recruitment arms 4-5: Nov 2010 End of recruitment arms 4-5: Jul 2011|Recruitment to part 1, including arms 1-3, completed before initiation of part 2 (arms 4-5). Arms 4 and 5 was a protocol amendment.
748976|NCT00708552|This study was conducted at 68 centers in the following 11 countries: Bulgaria, Chile, Czech Republic, Estonia, Germany, Greece, Korea, Mexico, Poland, Russia, and South Africa from 04 July 2008 to 09 Mar 2010 and a total of 967 participants were screened over the recruitment period of 55 weeks.|Of 967 participants screened, 618 (349 screen failures) entered into the placebo run-in period and a total of 576 (42 placebo run-in failures) were randomized of which 2 participants did not take study medication, formed Safety population (574) comprising of randomized participants who took atleast one dose of study medication.
748977|NCT00708526|Subjects were recruited from March 28-August 25, 2008 through the surgery schedule at the Moran Eye Center|
748978|NCT00708500||154 participants who discontinued during the treatment phase (including those from lead in and/or boceprevir/placebo) entered the follow up phase
748979|NCT00708461|Participants were recruited at worksites between January 2006 and April 2007. Human resources departments provided worksite contact information for all eligible employees; these email addresses and phone numbers were used for recruitment contact purposes.|A company-wide email was sent to eligible employees at all sites, describing the study and the partnership with the University. Employees were notified that a study staff member would contact them about the project within the next two weeks and were given the option to call study staff in advance to opt out or to enroll in the study.
748980|NCT00708435||
748981|NCT00708422|Patients were recruited from 21 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and abnormal TBUT were enrolled.|231 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received the test article and completed the study (intent-to-treat): 226.
748982|NCT00708305|Participants were recruited at the clinical site.|There was a four-day wash out prior to each treatment period during which participants used the study fluoride-free toothpaste. Two to three days prior to the start of each treatment visit, participants attended the study site for a dental prophylaxis then discontinued all oral hygiene prior to study treatment visit.
748983|NCT00708227|Participants were recruited from Nemours Children's Health System, the University of Florida Jacksonville, health fairs and events, Edward Waters College, and from previous study participation. Participants were recruited between January 2008 and October 2011|Enrolled participants were excluded from receiving planned study treatment if they did not meet the ADRB2 genotype criteria and if they did not have a methacholine PC20 of 12.5mg/ml or less.
748984|NCT00708214||According to the protocol the starting dose of Afatinib was 50mg/day. This dose was reduced according to the protocol to first 40mg/day and then to 30mg/day due to skin toxicity.
748985|NCT00708201||
748986|NCT00708175|Participants took part in the study at 25 investigative sites in the United States from 23 May 2008 to 02 February 2011.|Postmenopausal participants enrolled in 1 of 2 treatment groups to examine the effect of pioglitazone on bone mineral density (BMD) by dual-energy-ray absorptiometry (DXA). Participants with >7% decrease from baseline in BMD of the total proximal femur or spine based on DXA scan results (confirmed with a repeat scan) were to discontinue study drug.
748987|NCT00708162|Participants were enrolled in a total of 161 study sites in Australia, Europe, and North America. The first participant was screened on 19 June 2008. The last study visit occurred on 22 April 2015.|1335 participants were screened.
748988|NCT00708123|Participants were recruited at the clinical site.|Two days, prior to each treatment visit ,participants used a fluoride- free dentifrice twice daily to avoid any carry over effect.
748989|NCT00708110||
748990|NCT00708097||Two days before the start of each treatment period, participants received a professional dental cleaning of their natural teeth, then brushed at home with the fluoride-free toothpaste.
748991|NCT00708071|Patients were enrolled at 6 clinical sites in the United States, beginning June 2008 and completing in September 2008|56 participants were enrolled and screened. 2 were screen failures. 9 were withdrawn prior to randomization (1 due to untoward medical occurrence, 2 due to study site over enrollment, 2 requested withdrawal, 2 had scheduling conflicts, 1 had surgery delayed, 1 missed deadline for enrollment. Therefore, 45 of the 56 enrolled were randomized.
748992|NCT00708032|There were 74 subjects enrolled into the study, 38 into the TruEye group and 36 in the spectacle group. Forty-eight subjects completed the study.|
748993|NCT00708019|We recruited patients from October 2007 to December 2012 from oncology clinics in the San Francisco Bay area.|
748994|NCT00707993|Participants enrolled at 110 investigative sites in Hungary, India, Israel, Mexico, Peru, Poland, Romania, Russia, South Africa, the Ukraine and the United States from 25 June 2008 to 30 August 2010.|Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of two, once-daily (QD) treatment groups.
748995|NCT00707980|Participants took part in the study at 88 investigative sites in Australia, Croatia, France, Germany, Korea, Latvia, Lithuania, Malaysia, The Netherlands, Poland, Russia, Taiwan, Ukraine, and the United States from 17 June 2008 to 23 August 2010.|Participants who completed short-term efficacy and safety studies Lu AA21004_304 (NCT00672620) and LuAA21004_305 (NCT00735709) were eligible to receive the 52-week treatment with vortioxetine in this open-label extension study.
748996|NCT00707967||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
748997|NCT00707954||
748998|NCT00707915|psychiatric hospital & nursing home|
748999|NCT00707863||
749000|NCT00707759||
749001|NCT00707746||42 patients were screened, 34 participants were randomized, and 33 participants were treated: 21 participants to mipomersen and 12 participants to placebo.
749002|NCT00707655||
749003|NCT00707577||
749004|NCT00707486|Subjects were recruited as they presented at the site of the study for extraction. Subjects served as their own control as they had four extractions per procedure and two served as the experimental sites and two served as the control sites.|
749005|NCT00707447||
749006|NCT00707434|Recruitment period: June 12, 2008 to May 19, 2011. All recruitment was done at The University of Texas (UT) and UT MD Anderson Cancer Center.|
749007|NCT00707343||
749008|NCT00707239||
749009|NCT00707174||
749010|NCT00707161||
749011|NCT00707057|Date First Subject Enrolled: 24 June 2008 Date Last Subject Enrolled: 11 October 2008 All subjects were to receive 4 doses of study drug or placebo at 12-hour intervals. Of the 12 subjects who prematurely discontinued study drug, 6 subjects received 1 dose of study drug, 2 subjects received 2 doses, and 4 subjects received 3 doses.|
749012|NCT00707031|The study was conducted at 122 centers in 18 countries between June 23, 2008 and November 18, 2010. The overall duration of treatment was at least 76 weeks (24 weeks main open-label treatment; variable open-label extension treatment).|A total of 1243 patients were screened of which 604 were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 639 patients were randomized.
749013|NCT00706992||
749014|NCT00706979|Participants were recruited from 1/2009 - 2/2010 via the internet from an email database of potential enrollees provided by a market research firm. Eligible participants were mailed an informed consent and asked to return a signed copy if they wished to participate. Research staff then made calls to initiate formal study enrollment.|Participants were randomized to treatment group in a 1:1 ratio using a random number generator with block randomization before research staff made calls to initiate formal study enrollment.
749015|NCT00706966|Patients were recruited from June 2005 to June 2008 from untreated patients seen at the University of California San Francisco|
749016|NCT00706914|This study was conducted in 31 sites in the United States (US). All sites screened at least one patient and, of these 31 sites, three sites did not enroll any patients. The first patient was screened in March 2008 and the last patient visit was in February 2009.|
749017|NCT00706901||
749018|NCT00706849||Two hundred and twenty-five patients were screened and 124 participants were randomized on Day 1 in a 2:1 ratio to receive mipomersen or placebo once a week for 26 weeks.
749019|NCT00706836|Healthy subjects recruited by posted advertisements.|Subjects determined to be healthy based on physical examination, mental health examination, and routine bloodwork.
749020|NCT00706823|The patients for this study have been recruited from Feb 2008 through July 2008. The patients were recruited from the day surgery and holding areas.|
749021|NCT00706810||
749022|NCT00706797||141 participants were randomized, 1 participant performed all the planned visits, and 140 participants were discontinued before completion of the study; 115 participants prematurely withdrew due to discontinuation of the study by the sponsor.
749023|NCT00706784||
749024|NCT00706719||
749025|NCT00706706||
749026|NCT00706654||There were 3 phases in this study. In phases 1 and 2 (Conversion Phase and Oral Stabilization Phase), there was 1 reporting group. In phase 3 (Depot Maintenance Phase), there were 3 reporting groups. All Outcome Measures were assessed in the Depot Maintenance Phase of the study.
749027|NCT00706641||
749028|NCT00706628||
749029|NCT00706589|Recruitment period :Aug2008~Jan2010 Types of location: Medical Center|antipsychotic or antiparkinson drugs should be washed out 1~2 weeks prior to randomization.
749030|NCT00706563||
749031|NCT00706550|A total of 107 patients were enrolled on the study (11/2008-2/2011 at the Michael E. DeBakey VA Medical Center, at Thomas Street Clinic and at Legacy Clinic, in Houston, TX. Only the patients that completed the 1 month post-PV visit are included in the analysis (N=36 for each arm for a total of 72 out of the 107 initially enrolled).|
749032|NCT00706511||
749033|NCT00706485||
749034|NCT00706446|Recruitment for the GABLE study took place from 06/01/2008 to 06/01/2010 at the Asthma Research Center at Brigham and Women's Hospital.|
749035|NCT00706433|Recruitment period: 3/7/07 - 3/31/08 Types of location: medical clinics|no enrolled participants excluded from the trial before assignment to groups
749036|NCT00706407||
749037|NCT00706381||
749038|NCT00706355||
749039|NCT00706342||
749040|NCT00706329|physician office|59 medical records were screened; 25 were eligible and received Deflux
749041|NCT00706238||
749042|NCT00706134||
749043|NCT00706121||
749044|NCT00706095|This study was recruited at 2 centers in The Netherlands during the period of Feb 2008 to Jan 2010.|
749045|NCT00706030||
749046|NCT00706004||
749047|NCT00705939|Patients completing Studies PB-06-001 (NCT00376168) or PB-06-002 (NCT00712348) were offered continued treatment in this study.|
749048|NCT00705874|The recruitment period was June 2006 through March 2011, with last patient being treated May 2011. Patients were recruited through oncology clinics.|There was no run-in phase. Patients were assigned to treatment arm based on their cancer type and which standard of care therapy was appropriate based on Investigators' discreation.
749049|NCT00705783||There were 4 phases in this study. In phases 1-3 (Conversion Phase, Oral Stabilization Phase, Depot Stabilization Phase), there was a single treatment group. In phase 4 (Depot Maintenance Phase), there were 2 treatment groups. All Outcome Measures were assessed in the Depot Maintenance Phase of the study.
749050|NCT00705757||
749051|NCT00705718||
749052|NCT00705679|Women were recruited from September 2009 through June 2011 from 15 sites in South Africa, Uganda, and Zimbabwe.|12,320 women were assessed for eligibility and 7,291 were excluded for various reasons, including 2,308 women who were HIV-positive. 5,029 women were randomized.
749053|NCT00705666||
749054|NCT00705653||
749055|NCT00705614|The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.|
749056|NCT00705575||
749057|NCT00705536||
749058|NCT00705523||
749059|NCT00705484||
749060|NCT00705432|1472 participants were enrolled in this study.|373 participants were screened but not randomized. 1099 participants were randomized. Only 1097 received at least one dose of PegIntron (PEG) + Ribavirin (RBV) (lead-in treatment).
749061|NCT00705406||
749110|NCT00703391|First patient enrolled: 11 June 2008. Last patient completed: 09 October 2008. Single-centre study performed at a Clinical Pharmacology Unit|
749062|NCT00705367||Thirteen (13) participants were enrolled in the short-term period of the study. Four (4/13, 30.8%) of these participants were not randomized: 3 (23.1%) no longer met study criteria after screening, and 1 (7.7%) withdrew consent. All 9 participants who completed the short-term period entered the long-term period.
749063|NCT00705341||
749064|NCT00705289||
749065|NCT00705263||113 patients were enrolled in the study; however, data were available for 110 subjects
749066|NCT00705250||
749067|NCT00705224||
749068|NCT00705159|This study was conducted at 17 sites in the United States. First participant was enrolled on 6/26/2008 and last participant visit was 3/24/2010.|A total of 137 pediatric subjects, 0 to 6 years of age, of either gender and any race, who had a clinical diagnosis of blepharoconjunctivitis in at least one eye were randomized in this study. 126 Participants completed the study.
749069|NCT00705146|Participants were recruited from 3 outpatient hand therapy departments on Vancouver Island from April 1, 2008 to April 30, 2009.|
749070|NCT00705133||
749071|NCT00705107||
749072|NCT00705081||
749073|NCT00705016||
749074|NCT00705003|Patients were recruited at 9 study centers between April and December 2008|
749075|NCT00704964||
749076|NCT00704938||
749077|NCT00704912||217 subjects consented for the study, of which 149 were randomized to one of the 3 treatment groups. Sixty-eight subjects were not randomized because they withdrew prior to randomization or were determined ineligible during the screening process.
749078|NCT00704847|"Patients were enrolled at 18 centers in 10 countries: 6 centers in the US, 1 center in the UK, 1 center in Spain,1 center in the Czech Republic, 3 centers in Denmark, 1 center in Hong Kong, 2 centers in Poland, 1 center in Romania, 1 center in Belgium and 1 center in Canada.
~First patient randomized: 1 Aug 08 Last patient visit: 10 May 2011"|
749079|NCT00704808||
749080|NCT00704769||
749081|NCT00704730|First patient enrolled 10 September 2008, last patient enrolled 27 February 2011. Data cut off date 15 June 2011.|
749082|NCT00704717||
749083|NCT00704535||
749084|NCT00704522||
749085|NCT00704496||data disposed of and no longer in existence
749086|NCT00704418|This study was conducted at 19 sites, first participant entered the study 06/03/2008 and last participant completed the study 08/29/2008.|A total of 156 participants were randomized to investigational product and were included in the Intent-to-Treat (ITT) population; 78 were randomized to the bromfenac ophthalmic solution treatment group and 78 were randomized to the placebo treatment group.
749087|NCT00704405|Non-cirrhotic (NC) and cirrhotic (C) participants were screened and enrolled separately in this study. The NC population was used for all safety, tolerability, and efficacy outcome measures. Primary analyses of the outcome measures only included the NC population. Adverse events (AEs) were monitored in both the NC and C populations.|
749088|NCT00704379||
749089|NCT00704353|Hospitals and medical clinics|
749090|NCT00704340|First subject was enrolled on September 12, 2005, last subject visit was May 20, 2009.|Randomized study, no washout or run-in period.
749091|NCT00704262|The treatment phase was divided into two 4-week treatment periods during which the overall treatment duration had to be 28 days or 56 days. The participant was to leave the study if they were clear according to the investigator's global assessment of disease severity (IGA) of the face and of the intertriginous areas at Visit 3 (Day 28).|
749092|NCT00704184||During the double-blind phase (Day 1 to Day 28), participants took Vaniprevir or Placebo in combination with Pegylated Interferon (Peg-IFN)/Ribavirin. During the open-label phase (Day 29 to Week 48), participants took Peg-IFN/Ribavirin only.
749093|NCT00704171|Between January 28, 2008 and October 21, 2008, a total of 161 subjects were consented and screened for potential study participation at 8 institutions (hospitals). Of these subjects, 121 were randomized.|Subjects were evaluated for pre-operative and intra-operative eligibility criteria. Randomization occurred intra-operatively.
749094|NCT00704132||57 participants were enrolled in this study. Of these, 7 participants with normal fasting glucose (NFG) only underwent pre-randomization experiments and did not receive an allocation number, were not randomized to one of the treatment groups, and did not receive double-blind study medication.
749095|NCT00704028|Hospitals and medical clinics|One subject randomized to iron dextran never received study drug and was discontinued due to subject request.
749096|NCT00703976||Although 80 patients were enrolled, only 78 began the study because 2 were found to be ineligible prior to treatment.
749097|NCT00703963|Subjects were recruited from the Mayo Clinic, Rochester, Minnesota from June 2007 to January 2009.|
749098|NCT00703937|Hospitals and medical clinics|5 subjects randomized into the trial were discontinued prior to dosing.
749099|NCT00703924||
749100|NCT00703911||
749101|NCT00703885|All subjects receive both doses of active drug and placebo in randomized order.|All subjects receive both doses of active drug and placebo in randomized order.
749102|NCT00703846||
749103|NCT00703820|324 participants enrolled between August 2008 and March 2017.|Prior to starting the study, 62 participants were excluded for the following reasons: 29 participants were donors, 8 were determined to be ineligible (wrong diagnosis), 2 were MPAL (mixed AML) patients, and 23 were not randomized.
749104|NCT00703781|Study start date was 06/10/2008 and last participant to exit the study was 09/02/2008. This study was conducted in 18 study centers.|A total of 126 subjects were randomized to investigational product and were included in the Intent-to-Treat (ITT) population; 63 were randomized to the bromfenac ophthalmic solution treatment group and 63 were randomized to the placebo treatment group.
749105|NCT00703729||
749106|NCT00703677|The protocol was open for recruitment between September 2008 and August 24, 2009 at neurology clinics affiliated with university hospitals.|
749107|NCT00703664|Participants were enrolled at 12 participating cancer center sites in the United States, from July 2008 through December 2013.|
749108|NCT00703534||
749109|NCT00703508||55 subjects were enrolled, however some subjects failed to meet eligibility criteria resulting in 26 subjects initiating and completing all study phases.
749111|NCT00703339||
749114|NCT00703157||Eighty (80) subjects were enrolled, of whom 52 were randomized. A Reveal XT Implantable device was implanted in all subjects after Informed Consent. The subjects were followed for a minimum of 1 week and a maximum of 6 months. If the subject demonstrated a minimum of 10% AF burden during this period and had complaints, the subject was randomized.
749115|NCT00703118|The study was conducted at 105 sites in 17 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, United Kingdom, Israel, Italy, Netherlands, Poland, Sweden, and the United States.|662 participants were treated (266 participants in the T12/PR48 group, 264 participants in the T12(DS)/PR48 group, and 132 participants in the Pbo/PR48 group) in this study.
749116|NCT00703092||
749117|NCT00703053|Healthy ambulatory adults were recruited from the surrounding communities of the research clinics from September 8, 2008 to November 12, 2008.|
749118|NCT00703014||Period one consists of mothers from the Base Trial P05787 (NCT00696800), randomized to treatment groups Corifollitropin Alfa (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of mothers (N = 541) who enrolled in trial P05712. Period three consists of miscarried/stillborn fetuses and infants born in trial P05712.
749119|NCT00702962|Open to accrual 09/2008 as Phase I study. Three participants treated with dose level 1. Similar NCI-CTEP Phase I trial (NCI 8703) established the maximum tolerated dose (MTD) for the study drug. This study was amended to Phase II using the NCI established dose. One participant treated on Phase II. Closed to accrual 01/2012 due to low enrollment.|"Eight patients total were consented (i.e. enrolled). Three of the 8 were determined to be ineligible upon screening. One of the 8 was eligible but subsequently declined participation soon after signing consent. Four (4) of 8 enrolled went to active treatment (started). Of these 4, 3 participated in Phase I and 1 participated in Phase II."
749120|NCT00702949|Total of 207 patients were enrolled on this trial between 06/20/2008, and 07/21/2008.|There were 16 cancels (6 in Arm I, 3 in Arm II and 7 in Arm III).
749121|NCT00702923||
749122|NCT00702884||
749123|NCT00702845||
749124|NCT00702780||
749125|NCT00702754|Approximately 500 subjects were recruited from 36 centers in North America.|Subjects had to be Botulinum Toxin Type B naive and could not have received a Botulinum Toxin Type A treatment within 12 weeks of enrollment.
749126|NCT00702715||
749127|NCT00702702||
749128|NCT00702689||
749129|NCT00702650||Subjects received Testosterone Metered Dose (MD)-Lotion for 120 days, at initial dose of 60 mg; may have had their dose adjusted up or down on Days 45 and 90 (3 were on 30mg; 97 on 60mg; 25 on 90mg; and 10 on 120mg). As primary outcome=subjects with normal testosterone at Day 120, results are presented for overall treatment group rather than dose.
749130|NCT00702624||
749131|NCT00702546||Period one consists of participants from the base study P05690 (NCT00702845) randomized to treatment groups corifollitropin alfa (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of eligible participants (N = 102) from the base study who enrolled in the follow up study P05711.
749132|NCT00702520||
749133|NCT00702507||The study consisted of 2 phases: initial treatment phase (14-day study period) and a follow-up phase (2-year study period).
749134|NCT00702468||
749135|NCT00702403||
749136|NCT00702377|109 dry eye subjects|Randomized, double-masked, parallel design
749137|NCT00702364|175 people responded to recruitment flier in the Denver area and were screened for eligibility from April 2008 through December 2011. 60 of these enrolled in the study.|60 enrolled participants completed study training; 2 of these withdrew prior to Baseline Assessment. 58 completed baseline assessment and began Placebo Run-in; 3 withdrew prior to randomization. 55 total were randomized.
749138|NCT00702338|Participants treated with either corifollitropin alfa + recombinant Follicular Stimulating Hormone (recFSH) or corifollitropin alfa + Human Chorion Gonadotropin (hCG) in P05693 (NCT00697255) and with an ongoing pregnancy were to be recruited for the following study.|Of 8 participants treated with corifollitropin alfa + recFSH (5) or hCG (3) in base study P05693 (NCT00697255), one participant from the corifollitropin alfa + hCG group was enrolled in the current follow-up study with an ongoing multiple pregnancy. No participants from the corifollitropin alfa + recFSH group enrolled in the current follow-up study
749139|NCT00702325|First participant enrolled on 05 June 2008, last participant last visit on 10 September 2009.|"10 subjects were excluded from the FAS: 9 who received the incorrect study medication and 1 who was randomized to receive SYMBICORT pMDI, but never received study medication.
~Therefore, 153 subjects (from 156 randomized to Symbicort) and 148 (from 155 randomized to Budesonide) were included in the FAS used to present baseline characteristics."
749140|NCT00702299||
749141|NCT00702273||Period one consists of participants from the base study P05787 (NCT00696800), randomized to treatment groups Corifollitropin Alfa (Cori Alfa) (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of eligible participants (N = 344) from the base study who enrolled in the follow up study P05716.
749142|NCT00702234|"Of 272 participants with ongoing pregnancy at 10 weeks after fresh embryo transfer (ET) in base study P05714 (NCT00696878), 268 enrolled in this follow-up study P05715. A participant could enter follow-up study without meeting formal definition for Completion of base study."|To complete base study P05714 (NCT00696878), a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3). For this follow-up trial P05715, study completion for participant (expectant mother) or live born infant was defined as completion of infant follow-up visit at 4-12 weeks after delivery.
749143|NCT00702221||
749144|NCT00702208|Recruitment from cervical cancer screening patients from three ambulatory clinics at the New York Presbyterian Hospital from December 1, 2008 to August 31, 2009.|Eligiblity criteria for participation were: 18 years of age or older, not currently pregnant, not currently breastfeeding, self-reported comfort reading in English or Spanish or their own. Women were scheduled to attend the clinic to use the self-lavaging device 1-3 months after their standard-of-care cervical cancer screening.
749145|NCT00702143||
749146|NCT00701935|"Initial planned enrolment was 12 months, starting August 2008. Eventual enrolment time was 3+ years - decision made to close end of 2011.
~Number of patients initially planned: 94 randomized and 74 completers Final number of patients: 80 randomized and 53 completers"|
749147|NCT00701805|A total of 107 of the 114 subjects who had completed Study M10-309 enrolled in this study, M10-312.|One of the 107 subjects withdrew consent before receiving study drug in this study. 106 subjects were treated with study drug. Two of these subjects were not included in the Full Analysis Set for analysis of efficacy because of subject death (n = 1) and withdrawal of consent (n = 1).
749148|NCT00701779|Medical Clinic|The population of subjects will be the 'Intent-toTreat' population.
749149|NCT00701727|Participants recruited at a research clinic, Chicago, IL, from June 2008 to October 2008|61 subjects screened, 30 subjects excluded(8 failed inclusion criteria, 9 failed exclusion criteria, 3 had unsuitable veins, 5 failed a drug screen, 1 was lost-to-follow-up, 4 were excluded when enrollment was complete), 31 subjects randomized.
749150|NCT00701714||
749151|NCT00701701|The study was conducted in 2 countries. A total of 5 participants were screened between 14 December 2008 and 17 August 2010 (dates when first participant and last participant signed informed consent), of which one participant died before enrollment.|A total of 4 participants were included and treated in this study. Participants were assigned to either Regimen A or Regimen B.
749152|NCT00701675||
749153|NCT00701662||
749154|NCT00701636|From July 2008 to August 2010, we recruited subjects undergoing CABG surgery at Harbor-UCLA Medical Center, a 400-bed tertiary-care county hospital.|
749155|NCT00701558||
749156|NCT00701441||
749157|NCT00701415|The study was conducted at 12 sites in 9 countries. A total of 44 participants were screened between 17 June 2008 and 12 April 2010.|Of 44 screened participants, 31 were randomized in 1:1 ratio to fabrazyme 0.5 mg/kg and fabrazyme 1.0 mg/kg within each age stratum (5 to ≤11 years [children] and 12 to ≤18 years [adolescents]). 13 participants were screen failure due to failure to meet inclusion criteria or withdrawal of consent prior to all screening assessments being completed.
749158|NCT00701389||
749159|NCT00701376||
749160|NCT00701363|Study initiation date: 06-Oct-2008. Study completion date: 20-May-2013. Screened subjects were 128 and screen failure subjects were 4. Subjects treated were 124 and subjects withdrawn early were 17. Subjects completed the study were 107.|
749161|NCT00701311|Recruitment took place over approximately one year from the offices of private urologists.|A total of 21 male subjects meeting inclusion criteria were recruited. Of these, two failed screening and two were enrolled but did not start drug. Therefore 17 subjects started treatment drug.
749162|NCT00701129|The study was conducted at 2 centers in the United States of America between October 01, 2009 and March 27, 2013.|
749163|NCT00701103|Participants who were ≥18 years old, had metastatic or locally advanced solid tumors (including multiple myeloma) and failed to respond to standard therapy, or had progressed despite standard therapy, or for whom standard therapy did not exist were recruited for this study.|
749164|NCT00701090|"Phase III
~First Patient In: 14-May-2008; Last Patient Last Visit: 27-Oct-2009; 109 study centers worldwide"|Patients at least 18 years of age with type 2 diabetes mellitus with inadequate glycemic control (A1C ≥6.5 and ≤9.0%) on a stable dose of metformin (at a dose of at least 1500 mg per day for at least 12 weeks) were eligible to enter the 30 week study. Up to a 2 week screening period, followed by a 2-week placebo run-in.
749165|NCT00701064||
749166|NCT00701051||
749167|NCT00701038||
749168|NCT00700999|Participants were recruited in this study from 3/1/09 to 12/31/11. Participants were recruited by flyers in the community and within the Ann Arbor Veterans Affairs Health System and through professional referrals within the Ann Arbor Veterans Affairs Health System through the outpatient psychiatry clinics and primary care clinics.|All participants went through an initial screening visit in which they signed the informed consent document and completed multiple assessments and a medical evaluation in order to assure that they were able to participate in the study and that they did not meet any exclusionary conditions.
749169|NCT00700973||
749170|NCT00700882|A total of 81 patients were accrued between May 1, 2009 and December 28, 2015 and the study was closed due to slow accrual.|
749171|NCT00700817|A total of 158 centres in 13 countries participated: Canada (11), Croatia (3), Germany (12), Ireland (5), Italy (8), Netherlands (8), Romania (4), Serbia (3), Slovakia (6), Slovenia (3), Spain (9), United Kingdom (20) and United States (66). Of the 158 sites approved by an Independent Ethics Committee, 151 actively screened and enrolled subjects.|Between screening and randomisation, eligible subjects were to continue their usual pre-study metformin dose and dosing frequency.
749172|NCT00700804|Post menopausal women willing to eat controlled diet at United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center for 14 weeks|Subjects were assigned to either the High or Low Calcium diets. The subjects then consumed the high and low protein diets in random order, i.e. half of the subjects consumed high protein, then low protein while the other half consumed low protein, then the high protein diet. Drop-outs were replaced.
749173|NCT00700752||
749174|NCT00700739|5 sites enrolled 60 subjects who were randomized into two treatment groups. Site 12 (17 subjects total) transferred into the Discover IDE study. Site 04 (5 subjects total) did not submit data, which was limited, due to EDC technical difficulties at the site. Therefore 38 subjects are reported in this study.|
749175|NCT00700713|Study participants were enrolled from 17 June 2008 to 01 October 2008 at 13 clinical centers in the United States.|A total of 181 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
749176|NCT00700635|Participants were enrolled from 17 June 2008 to 25 July 2008 in 13 of 15 medical centers in the US.|A total of 333 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
749177|NCT00700622|The FPFV was May 30, 2008. Multinational trial conducted in the US and Brazil.|2 week screening period prior to randomization - 276 Screened / 138 Eligible. 130 subjects were randomized; 138 screen failures and 8 discontinued prior to randomization.
749178|NCT00700570||
749179|NCT00700440|2008-7-1 ~ 2009-4-3|
749180|NCT00700427||The study consisted of 4 treatment periods: 12 weeks open-label, acute-treatment (trx) phase (Study Period 2), 12 weeks double-blind maintenance phase of Study Period 3 (Study Period 3A), 25 weeks double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B) and an Open-Label Extension Period (Study Period 4) lasting up to 2.3 years.
750030|NCT00658528||Out of 1061 participants who were randomized, 1055 participants received study treatment.
749184|NCT00700271||Eligible patients entered a 4-week open-label amlodipine screening phase with amlodipine 5 mg taken orally once a day. At the end of the screening phase, patients whose blood pressure was not adequately controlled (defined as SBP/DBP >= 125/80 mmHg 24-hr mean) on ambulatory blood pressure monitoring were randomized to one of two treatment groups.
749185|NCT00700180||
749186|NCT00700141||
749187|NCT00700115|All subjects were recruited from an urban outpatient HIV clinic (the Grady Infectious Diseases Program Out-patient Clinic, Atlanta, Georgia) between June 2008 and January 2011.|Subjects were excluded if they were on medications that could interact with Protease inhibitors, had an active opportunistic infection, had renal and/or hepatic impairment, or were pregnant. Hepatitis B virus (HBV) co-infected patients receiving a nucleotide analogue for both HIV and HBV suppression were also excluded from enrollment.
749188|NCT00700102|This study enrolled 820 patients at 220 sites located in 15 countries in Europe and Saudi Arabia. Study AIO KRK 0504 enrolled 261 patients, and 559 patients subsequently enrolled in Study ML18147 when the study was transferred to Hoffmann LaRoche (in 2008).|
749189|NCT00700063|First patient randomized: 24 June 2008 Last patient completed Day 57: 20 October 2008|
749190|NCT00700011|The recruitment period started 3/24/08 (date of consent of the first patient), to 4/8/10 which was the date IRB lists as date of study closure. All patients were consented and treated at our clinic, Texas Oncology - Amarillo. Eight patients were treated to the 10 mg/m2 arm and two patients to the 5 mg/m2 arm. Study closed due to poor recruitment.|There were no screen fails due to pre-screening thoroughly. The plan was to sign eight patients to the 10 mg/m2 arm and then eight to the 5 mg/m2 arm, but recuitment was difficult and decision was made to close study in early 2010, so only two patients were assigned to 5 mg/m2 arm.
749191|NCT00699998||
749192|NCT00699972|A total of 534 participants were screened for entry into the study. Of 534 participants, 147 were screen failures and 387 were eligible to continue in the study. A total of 390 participants were randomized into the study; 387 who were eligible and 3 who failed screening but were inappropriately randomized (2 received study treatment and 1 did not).|This was a randomized, double-blind, placebo-controlled study consisting of three phases: Prerandomization, Double-blind, and Follow-up. Participants who experienced the required minimum number of seizures during prerandomization, entered the Double-blind Phase and were randomized to placebo or 8 or 12 mg perampanel groups.
749193|NCT00699907|Participants were recruited from the medical clinic prior to oophorectomy. Participants were recruited from January 2007 until June 2011.|Participants were assigned to groups immediately after being enrolled.
749194|NCT00699842||
749195|NCT00699816|This phase 3 clinical study was a multicenter, randomized, open-labeled trial. The study was conducted at 5 university affiliated hospitals in Korea. All eligible participants were assigned randomly, in a 1:1 ratio, to receive adjuvant adoptive immune therapy using a CIK cell agent or no adjuvant treatment.|
749196|NCT00699803||
749197|NCT00699751|Subjects with progressive symptomatic hormone refractory prostate cancer (HRPC), with at least 2 skeletal metastases on bone scan and no known visceral metastases, could participate in the study.|Subjects were to be randomized in a 2:1, a total of 921 subjects were enrolled in the study and were randomized to receive either Alpharadin [Radium-223 dichloride (Xofigo, BAY88-8223)] or placebo study treatment, which resulted in 614 subjects enrolled in the Alpharadin group and 307 enrolled in the placebo group.
749198|NCT00699699||
749199|NCT00699660||
749200|NCT00699608||
749201|NCT00699582||
749202|NCT00699556||
749203|NCT00699491||
749204|NCT00699413||
749205|NCT00699400||
749206|NCT00699374||One participant was randomized twice, once to the sorafenib arm and discontinued prior to receiving treatment and a second randomization to the sunitinib arm and dispensed treatment.
749207|NCT00699348||
749208|NCT00699335||
749209|NCT00699283|This multi-Center study started to enroll subjects in August 2008 and concluded in March 2010.|"The Participant Flow refers to the Randomized Set (RS). Subjects withdrawn due to meeting an exit criterion are included in the count of early discontinuations with a reason of Adverse Event or Lack of efficacy as reported by the Investigator."
749210|NCT00699218||
749211|NCT00699192|965 patients were enrolled in the study. Of these, 819 met the criteria for entry into the double-blind phase of the study where efficacy and safety were evaluated.|
749212|NCT00699153|This study was conducted at 16 sites in the US. The first participant was enrolled June 20, 2008 and the last participant visit was May 1, 2009.|405 participants, who were candidates for routine, uncomplicated cataract surgery were enrolled in the study.
749213|NCT00699140||
749214|NCT00699010||
749215|NCT00698997|Children were recruited from pediatricians, developmental disability settings, and university website postings using IRB-approved materials.|
749216|NCT00698932||
749217|NCT00698867||
749218|NCT00698841||Of 79 participants enrolled, 51 received treatment.
749219|NCT00698815|Between April 2008 and September 2011, 130 participants were recruited.|
749220|NCT00698685|Following University of Arizona IRB review and approval, the study opened to accrual on November 2005 at the Arizona Cancer Center clinic and University Medical Center sites [Tucson, Arizona].|Following consent process, subjects who consented to participate were screened per the selection criteria in the study.
749221|NCT00698646||
749222|NCT00698581|This study started to enroll patients in August 2008 and concluded in February 2010.|"The Participant Flow refers to the Randomized Set (RS). Subjects withdrawn due to meeting an exit criterion are included in the count of early discontinuations with a reason of Adverse Event or Lack of efficacy as reported by the Investigator."
749223|NCT00698516||
749224|NCT00698451||
749225|NCT00698204|"Recruitment period University of Connecticut Health Center: December 2003 through December 2004 and from March 2006 through June 2011.
~Recruitment period Hartford Hospital: March 2010 thorough June 2011."|Three participants enrolled in the study but were not randomized. Two did not meet blood test eligibility criteria for randomization (liver function test, renal function test failure) and one withdrew shortly after enrolling, prior to randomization.
750031|NCT00658515||
749226|NCT00698139|"Overall 3 subjects completed the study.
~One subject underwent the intervention only (i.e., 6 hours of faster pacing). Subsequently the protocol was modified to a prospective, randomized single-blind, cross over design. Two subjects completed the protocol according to this modification and underwent both real and sham intervention."|
749227|NCT00698035||Of 76 enrolled participants, one participant consented and was assigned to ESTRING, but did not insert ESTRING prior to withdrawing from the study.
749228|NCT00698022||
749229|NCT00698009|Recruitment period June 05, 2008 to December 03, 2010. All recruitment done at UT MD Anderson Cancer Center.|
749230|NCT00697827||
749231|NCT00697801||
749232|NCT00697788||
749233|NCT00697697||
749234|NCT00697619||
749235|NCT00697593|Date of first subject first visit: 22 January 2008 Date of last subject last visit: 21 April 2009 Subjects were enrolled at 13 study centers in 2 countries, including 10 study centers in Canada and 3 study centers in the Netherlands.|Subjects were to be screened for study eligibility within 14 days before Day 1
749236|NCT00697541||
749237|NCT00697515||The study consisted of a 4-week dose optimization phase (30, 50 or 70 mg SPD489 once-daily) and a 2-week crossover phase. Of the 142 subjects enrolled in the dose optimization phase, 15 discontinued prior to randomization.
749238|NCT00697463|Premenopausal women, aged 20-48, with documented adult low trauma fractures or low aBMD by DXA; T score<-2.5 or Z score<-2.0 at the spine or hip and no history of adult low trauma fracture, were recruited at Columbia University Medical Center, NY and Creighton University, NE by advertisement, self- or physician referral.|No pre-assignment details to report
749239|NCT00697346|Participants took part in the study at 10 investigative sites in the United States from 11 July 2008 to19 October 2016.|Participants with a diagnosis of advanced hematological malignancies were enrolled 1 of 3 treatment groups, Part 1:alisertib powder-in capsule (PIC) 25 to 90 mg dose escalation cohort, Part 1: alisertib 30 to 50 mg enteric-coated tablet (ECT) dose escalation cohort, or Part 2: alisertib ECT 50 mg participants with peripheral T-cell lymphoma (PTCL).
749240|NCT00697255||5 participants were enrolled in Stage 1a to receive corifollitropin alfa + recombinant Follicular Stimulating Hormone (recFSH), and 3 participants were enrolled in Stage 1b to receive corifollitropin alfa + Human Chorion Gonadotropin (hCG).
749241|NCT00697203||
749242|NCT00697190||
749243|NCT00697112||
749244|NCT00697073||
749245|NCT00696878||To complete study, a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3).
749246|NCT00696800||Of 1509 randomized participants, 1506 received treatment with either Corifollitropin Alfa or recFSH (Intent-to Treat population [ITT]).
749247|NCT00696787|Subjects were recruited in the United States from June 2006 to November 2008.|After a 7 to 30 day screening period, eligible subjects entered a 7 day single blind placebo run-in period during which placebo responses were assessed.
749248|NCT00696774||270 participants began the study. 26 were screen failures (17 did not meet entry criteria, 7 decided to withdraw, and 2 withdrew based on the physician's decision). 2 participants discontinued before enrollment (1 was lost to follow-up and 1 decided to withdraw).
749249|NCT00696761|Participants recruited from a specialty clinic at the Asan Medical Center, Samsung Medical Center,The Catholic University of Korea College of Medicine, Hallym University, Chuncheon, Korea for 12-month|232 participants recruited; 276 screened, 44 excluded
749250|NCT00696709|The study was performed in 2 parts - Part 1 and Part 2, with a total of 160 participants.|In Part 1, all participants received heat-treated varicella zoster virus (VZV) vaccine, gamma-irradiated VZV vaccine A or placebo administered as a 4-dose regimen approximately every 30 days. In Part 2, all participants received either gamma-irradiated VZV vaccine B or C administered as a 4-dose regimen approximately every 30 days.
749251|NCT00696696|The study enrolled 45 patients from September 2007 to May 2010 at New York University Medical center and affiliated hospital, New York, NY and Desert Regional Medical center, Palm Springs, CA.|One patient was enrolled but then withdrew consent before treatment.
749252|NCT00696657|The trial was conducted at 80 sites in 14 countries: Austria (8), Bulgaria (6), Finland (6), France (5), Germany (7), Hungary (5), India (4), Italy (6), Serbia (3), South Africa (3), Spain (6), Switzerland (4), Turkey (5), and United Kingdom (12).|Study Design: This was a 9 armed parallel group trial. Subjects were randomised in a 1:1:1:1:1:1:1:1:1 manner to receive one of five doses of blinded semaglutide once-weekly (0.1 mg, 0.2 mg, 0.4 mg, 0.8 mg, 0.8 mg T [with titration] and 1.6 mg T [with titration]) or blinded placebo once-weekly or open-label liraglutide 1.2 mg or 1.8 mg once-daily.
749253|NCT00696618|Study participants were recruited to the outpatient clinical unit via a volunteer screening database.Similarly, individuals may have responded to advertisements posted throughout the Johns Hopkins Medical Institutions or via word of mouth from other research participants. Individuals were recruited between 10/10/07 and 01/06/09.|Seventeen subjects were recruited. Eight individuals did not meet screening criteria and were not enrolled.
749254|NCT00696488||
749255|NCT00696449||
749256|NCT00696436|Participants enrolled at 141 investigative sites in Guatemala, Mexico, Peru, Puerto Rico and the United States from 02 April 2008 to 19 August 2009.|Participants with essential hypertension were enrolled in one of five, once-daily (QD) treatment groups.
749257|NCT00696423||
749258|NCT00696410|"Patient were mainly recruited from the University of Michigan outpatient Cardiovascular clinic. 10 healthy controls (to quantify normal values and QA laboratory results for novel measures) were recruited from the community via advertisement."|The study was intended to run for 6 months. After further discussion with experts in zinc therapy, we opted to extend the study to 10 months.
749259|NCT00696384|Participants enrolled at 51 investigative sites in Argentina, Mexico and the United States from 22 June 2007 to 08 May 2009.|All participants that completed the open-label phase were randomized into a double-blind reversal phase (to continue with azilsartan medoxomil or to placebo, in addition to any other antihypertensive medications received during the open-label phase).
749260|NCT00696293||
749261|NCT00696241|Participants enrolled at 147 investigative sites in Argentina, Mexico, Peru and the United States from 25 June 2007 to 08 October 2008.|Participants with essential hypertension were enrolled in one of five, once-daily (QD) treatment groups.
749262|NCT00696137||
749263|NCT00696072|Study started October 2008 and completed June 2014; 23 participants chose to remain on active treatment after the study completed.|120 participants were enrolled, randomized and treated.
749264|NCT00696020||A randomised, double-blind, parallel group study. Each patient received their randomised treatment for 28 days.
749265|NCT00695955|Participants enrolled at 39 investigative sites in Chile, Mexico and the United States from 22 June 2007 to 30 April 2010.|Participants with essential hypertension were enrolled in a once-daily (QD) treatment group.
749266|NCT00695903||
749267|NCT00695864||Of 31 patients enrolled, 17 did not experience withdrawal symptoms and were therefore not assigned an intervention.
749268|NCT00695669||
749269|NCT00695578||
749270|NCT00695565|Subjects were recruited from May 2008 until September 2009. All study sites were medical clinics.|"Subjects were required to meet all eligibility criteria at both the Screening and Baseline visits. If a subject met the Screening criteria but not the Baseline criteria, the subject was not eligible for enrollment.
~Two subjects were randomized but were not treated because they were found ineligible. They are not counted in the 180 enrolled."
749271|NCT00695500||Four participants were enrolled (consented) but withdrew prior to group assignment.
749272|NCT00695435|Randomized, single center (Alcon Eye Clinic),|Treatment randomization schedules were generated and maintained by the Alcon SAS Programming group. Only when the data were verified and validated and the database locked were the appropriate personnel unmasked.
749273|NCT00695409||
749274|NCT00695396||
749275|NCT00695318||
749276|NCT00695292||
749277|NCT00695188|Patients were included at the outpatient unit of the Kaiser-Franz-Josef-Hospital, Department for Rheumatology, if they fulfilled the inclusion criteria|
749278|NCT00695136||Children were screened with polysomnography and 8 of 16 subjects were found to have low REM sleep% and were eligible to continue with the study. One of the 8 elected not to participate in the dose-finding drug administration.
749279|NCT00695097|Consecutive patients with biopsy-proven ACR were recruited in the kidney transplant Clinic at UCSF and were randomized to either the Rituximab or the control group.|18 patients were consented to participate. 3 patients failed eligibility screening prior to treatment assignment. 15 were eligible, 10 were in the Rituximab group and 5 in the no-Rituximab group.
749280|NCT00695019|Subjects undergoing treatment for HCV infection at one of the 9 participating hospitals were approached, and those willing to sign informed consent were screened for eligibility.|A total of 196 subjects were screened. All 169 subjects meeting eligibility criteria were randomized to one of the 3 treatment groups and all 169 were included in the intent-to-treat analysis.
749281|NCT00694707||
749282|NCT00694603|We recruited patients to this multicenter, single-arm, phase II clinical trial with ECOG PS 0 to 2 and advanced NSCLC who were previously treated with erlotinib or gefitinib. Patients with asymptomatic, stable CNS metastases were eligible. 18 eligible patients were enrolled in the first stage of the trial between October 2006 and March 2009.|All patients were required to have an available tissue sample for EGFR mutation testing, which was performed centrally at a CLIA-certified laboratory.
749283|NCT00694564||
749284|NCT00694551||
749285|NCT00694473||
749286|NCT00694369|Study Conducted at 3 investigational sites in the US. Patients were recruited from the sites patient pool and through advertising. A total of 588 patients were randomized. First Patient Entered 27-June-2008; First Patient In (randomized) on 03-July- 2008; Last Patient Last Visit 08-Jan-09|"Patients who met entry criteria and were experiencing moderate-to-severe pain after removal of at least 2
~third molars (at least 1 being partially or completely impacted and of mandibular origin) were allocated to
~the study. Wash-out period for exclusionary medication was specified in the protocol. Randomization was
~stratified by baseline pain."
749287|NCT00694356||
749288|NCT00694304|Patients eligible to participate in Study 11984B were patients who had completed lead-in Study NCT00635219 / 11984A immediately prior to inclusion into Study 11984B.|The study consisted of a 52-week open-label period and a 4-week Safety Follow-up Period.
749289|NCT00694161||
749290|NCT00694122|Recruitment began in January 2007 and ended on January 2011. Individuals were recruited from the MGH Diabetes Center, MGH internal Research Broadcast for research volunteers. Advertisements were placed in the local metro and flyers posted around the institution, altho no participants contacted study staff from these latter advertisemens.|200 participants were recruited; 43 were phone screened; 27 signed consent forms, 12 exluded (3 did not meet inclusion criteria, 7 no longer wanted to participate and 3 lost to follow-up).
749291|NCT00694109|The study was conducted at 33 centers in 7 countries. A total of 144 patients were enrolled in the study. 1 patient never received study drug. 2 of the enrolled patients came from a phase 2 study and its extension and consequently had very different treatment from the other treated patients, and thus were excluded from all summary tables.|Participants who successfully completed ISIS 301012 CS5 (NCT00607373), ISIS 301012CS7 (NCT00706849), ISIS 301012CS17 (NCT00694109) or MIPO3500108 (NCT00794664) with an acceptable safety profile were eligible for study.
749292|NCT00694096||
749293|NCT00694070||
749294|NCT00694018||
749295|NCT00693992||
749296|NCT00693784||
749297|NCT00693719||
749298|NCT00693706||
749299|NCT00693693|Participants were recruited from IRB approved advertising and the Dermatology Clinic.|
749300|NCT00693654|Subjects were recruited from 11/6/06 to 11/27/06 from the Salem Kidney Center in Winston Salem, NC.|Subjects were randomized so that half received Sarna lotion to be applied twice daily to all areas of pruritus, the other half applied placebo lotion twice daily to areas of pruritus.
749301|NCT00693628||
749302|NCT00693498|Potential subjects were recruited at pre-anesthesia inpatient assessments and outpatient pre-anesthesia appointments.|
749303|NCT00693485||
749304|NCT00693472||
749305|NCT00693420||
749306|NCT00693303||
749307|NCT00693238|University of Florida Proton Therapy Institute, between 04/2008 and 04/2010|
749308|NCT00693225|Subjects were recruited from the Mayo Clinic in Rochester, MN from June 20, 2008 to May 24, 2010.|One subject on the PM dose arm did not receive allocated intervention because the subject changed their mind soon after randomization.
749309|NCT00693160|31 healthy subjects between the ages of 19-51 were recruited and 30 were randomized between the dates for 11/20/2007 and 8/17/2010. Subjects were seen for all study related visits in the General Clinical Research Center at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina.|
749310|NCT00693017|This study was recruited at three study centers (1 in Australia and 2 in Hungary). A further 39 study centers in Europe and Australia were initiated. A total of 12 study sites in the following countries were not initiated; (2 in Finland), (3 in Czech Republic), and (7 in Ukraine) during the period of 04 June 2008 to 05 January 2009.|10 participants were screened for eligibility and six participants did not continue after the Screening Visit due to the Sponsor's decision to terminate the study. 4 participants were enrolled and treated during the study.
749311|NCT00692978||
749312|NCT00692913||
749313|NCT00692770|Participant recruitment period was between 15 August 2008 to 12 November 2010.|Of 1602 participants who were screened for inclusion in the study, 1114 were enrolled, and 1107 received treatment.
749314|NCT00692692|recruited from the clinic|
749315|NCT00692419||the number of patients recruited into the study beginning at the time of the observation phase (315) differs from the number of patients who continued in the study and were included in the intervention phase of the study (220)
749316|NCT00692406|Recruitment began on 6/23/05. We advertised in local newpapers, with flyers around Durham, and posting on dukeheatlh.org and dukesmoking.com. We recruited for this study until 11/08|If participants were excluded from the trial after enrollment it was due to inability to perform tasks, no shows to sessions, and or unsafe circumstances for the MRI sessions. Otherwise persons were lost to contact and/or decided to not participate anymore.
749317|NCT00692341||
749318|NCT00692276||
749319|NCT00692237|Eligible men were recruited from the outpatient clinics of Policlinico Umberto I - Sapienza University Hospital of Rome between 2008 and 2009.|Overall 66 patients were eligible and enrolled; Seven were then excluded due to evidence of aneurysm of ascending aorta (1) on stress-Echo and of ischemic heart disease (6) at the first CMR. Fifty-nine patients were randomized.
749320|NCT00692211||
749321|NCT00692198||
749322|NCT00692185||
749323|NCT00692094||The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
749324|NCT00692003|This study was recruited at 6 centers (3 in Romania and 1 in Australia, Hungary, and Lithuania) during the period of 01 August 2008 to 28 January 2009.|Twenty-one subjects were screened and 14 participants did not continue the study after screening. Seven participants entered the study but 1 participant did not receive any treatment. Consequently, 6 participants were enrolled and treated during the study. None of the 6 subjects completed treatment & all discontinued due to the Sponsor's decision.
749325|NCT00691938|The study opened to participant enrollment on 06/23/2008 and closed to participant enrollment on 11/06/2012.|
749326|NCT00691808|The study was performed at 2 centers in the Netherlands, one in Utrecht and one in Zuidlaren. Recruitment began in October of 2007 and the last subject completed the study in October of 2008.|
749327|NCT00691704|Recruitment began in July, 2008 and ended in October, 2010. Subjects were identified from Duke University Medical Center Hematologic Malignancies and Cellular Therapy program and University of North Carolina at Chapel Hill Lineberger Cancer Center for all demographic groups who meet the eligibility criteria.|
749328|NCT00691665|Study recruitment occurred from May 14, 2008 - July 31, 2008.|
749329|NCT00691652||
749330|NCT00691600||
749331|NCT00691574||The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
749332|NCT00691483||
749333|NCT00691444||The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
749334|NCT00691327||
749335|NCT00691301||
749336|NCT00691210||
749337|NCT00691197||
749338|NCT00691132||
749339|NCT00691093||
749340|NCT00691054||
749341|NCT00691028||
749342|NCT00691015||
749343|NCT00690924||
749344|NCT00690898|Newly diagnosed acromegaly patients with pituitary tumour were recruited at 27 investigational sites in 9 countries namely Belgium, Finland, France, Czech Republic, Germany, Italy, the Netherlands, Turkey and the United Kingdom.|
749345|NCT00690833||
749346|NCT00690820|Subjects were recruited in 10 centers in US between June 2008 and October 2008. Before the randomization, subjects were evaluated for eligibility. They underwent a short period of up to 14 days on their usual pancreatic enzyme supplementation.|Twenty three subjects had given their consent and 17 subjects were randomly allocated to pancrelipase/placebo or placebo/pancrelipase. One subject did not complete the first period of the treatment (consent withdrawal).
749347|NCT00690794|Patients were recruited from 70 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for at least one month immediately prior to Visit 1 were enrolled.|726 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and had at least one on-therapy study visit (intent-to-treat): 678.
749348|NCT00690755||
749349|NCT00690612|Hypertensive children aged 1 to <11 years who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621). First patient enrolled 17 Sep 2007 and last patient completed 9 Sep 2009 at Pediatric clinics in Europe.|Patients who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621) and did not discontinue study due to a study drug-related adverse event (AE) and had an ongoing clinical indication for treatment with candesartan.
749350|NCT00690573||Adalimumab dose was determined by baseline body weight (20 mg for subjects weighing < 30 kg, 40 mg for subjects weighing 30 kg or more) through Week 14. After Week 16, dose was based on body weight measured at Week 16 and every 12 weeks. Twenty subjects received concomitant methotrexate therapy during the study.
749351|NCT00690495|First patient in: 07.05.2008 Last patient out: 24.09.2008|
750062|NCT00656513||
750063|NCT00656487||
749353|NCT00690443|This study was performed from 12 May 2008 to 29 Aug 2008. A total of 5 medical clinics participated in the study.|5-week run-in period during which patients were to follow a low-fat diet and washout from previous lipid lowering therapies.
749354|NCT00690430|186 patients were screened and 110 were randomized into the study.|
749355|NCT00690378||
749356|NCT00690339||
749357|NCT00690274||
749358|NCT00690235||
749359|NCT00690040||
749360|NCT00689936|This study was conducted in the Europe, Asia, North America and Pacific regions. Participants were randomized at 246 sites (165 in Europe, 23 in Asia, 39 in North America, and 19 in the Pacific). The study was co-sponsored by Intergroupe Francophone du Myélome (IFM) (for sites in France, Switzerland, and Belgium) and Celgene Corporation.|Participants were stratified at randomization by 1) age (≤ 75 versus > 75 years), 2) stage (International Staging System Stages I or II versus Stage III), and 3) country.
749361|NCT00689884||
749362|NCT00689871|Enrollment: January 6, 1999-June 30, 2000 at multiple US sites|
749363|NCT00689819||
749364|NCT00689793|Premopausal female blood donors coming spontaneously to the donation center, were asked to participated to this study. After agreement an informed consent was signed.|One week after whole blood donation, participants were randomized if they were not anemic and their ferritin level was < or = 30 ng/mL.
749365|NCT00689728||Double-blind treatment was administered at Weeks 0, 3, and 6. At Week 16, participants not having at least a 20% decrease in tender or swollen joint counts could receive rescue therapy. Post-study B-cell follow-up (safety only) occurred beyond Week 24.
749366|NCT00689611||
749367|NCT00689481||
749368|NCT00689390|Participants were recruited from 9 boceprevir studies (P03523 [NCT00423670], P03659 [NCT00160251], P04487 [No NCT], P05101 [NCT00708500], P05216 [NCT00705432], P05411 [NCT00959699], P05514 [NCT00910624], P05685 [NCT00845065], and P06086 [NCT01023035]) and 1 narlaprevir study (P05104 [NCT00797745]).|1954 participants enrolled in this long-term follow-up (LTFU) study, with 1907 participants from 9 boceprevir studies and 47 participants from 1 narlaprevir study.
749369|NCT00689351||
749370|NCT00689338|Adult specific participants were recruited from intensive care unit (ICU) populations.|Two-hundred twenty one (221) participants were screened; 5 participants were screen failures who did not receive study medication.
749371|NCT00689299||
749372|NCT00689260|43 Subjects were randomized from 14 Clinics in the US from March 2008 through January 2009. One subject withdrew consent prior to first dose. Recruitment was ended early due to slow enrollment.|Screening and randomization took place at Visit 1 (Study Day 1) which consisted of informed consent, medical/disease history, physical exam and laboratory assessments.
749373|NCT00689221|First/last participant (informed consent): Sep 2008/Aug 2011. Clinical data cut-off: 19 Nov 2012, Study completion date: Aug 2013.|Enrolled: 3471 screened for eligibility; 2926 excluded (mainly due to unmethylated O6-methylguanine-DNA methyltransferase status and non-fulfillment of inclusion or exclusion criteria), 545 participants randomized.
749374|NCT00689117||
749375|NCT00689104||After screening, 2336 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 1987 eligible patients were randomly assigned to receive placebo, mirabegron 50 mg, mirabegron 100 mg or tolterodine 4 mg for 12 weeks.
749376|NCT00689091||22,185 patients were recruited but 584 were excluded after recruitment due to change in anesthetic technique, case cancellation, withdrawal, or death. Therefore, 21,601 patients were randomized.
749377|NCT00689078|Subjects were recruited from one site in the US.|Participant flow and baseline characteristics are presented for the 36 subjects that met all inclusion and none of the exclusion criteria and were randomized to receive Pred Forte, Pred Mild, Alrex, or Tears Naturale. 36 subjects were enrolled, 4 discontinued, and 32 subjects completed the study.
749378|NCT00689052||
749379|NCT00689026|Study participation was offered to all adult-onset diabetic outpatients 50 and over who were referred to the Gastroenterology clinic at the Medical College of Georgia in Augusta, Georgia for a screening colonoscopy from July, 2008 to March, 2010.|
749380|NCT00688935||The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
749381|NCT00688870|Subjects were recruited in Taiwan from June 2008 to Nov 2009|A total of 169 subjects were screened, 168 subjects were randomly assigned in a 1:1 ratio to either the 13vPnC group (n=84) or the 7vPnC group (n=84).
749382|NCT00688844|Recruitment lasted 1 year from October 2008 - October 2009. Recruitment occurred at the Emory University Genetics Clinic, Department of Human Genetics in Decatur, GA.|There were no exclusions of subjects once enrolled.
749383|NCT00688753||
749384|NCT00688740|Between June 1997 and June 1999, 1491 women from 20 countries were enrolled in the study. The last patient last visit occurred in January 2010.|Eleven women (1 who had been randomly assigned to receive TAC and 10 assigned to receive FAC) did not receive any treatment for the following reasons: 8 withdrew consent, 1 was lost to follow-up, and 2 did not receive treatment for other reasons. In total 1480 patients (744 in the TAC group and 736 in the FAC group) were treated.
749385|NCT00688701|The study was conducted at 61 centers (68 were initiated) in 12 countries between May 14, 2008 and December 14, 2009.|A total of 795 patients were screened of which 434 (54.6%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 361 patients were randomized.
749386|NCT00688688|Patients who completed the 12-week treatment and safety follow-up periods of studies 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909), as well as patients that did not participate in these studies were enrolled into this study if they met all inclusion criteria and none of the exclusion criteria.|After screening, 2792 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 2452 eligible patients were randomly assigned to receive mirabegron 50 mg, or mirabegron 100 mg or tolterodine ER 4 mg once daily for 12 months.
749387|NCT00688662|Subjects were recruited from medical clinics in 6 gastroenterology referral centers in USA between August 6 2008 and March 23 2012.|
749388|NCT00688636|Between 2005 and 2007 there were 24 adult patients with ileal or ileocolonic Crohn's disease undergoing resection who participated in the study.|
749391|NCT00688545||A total of 275 people consented to participate in this study. One person should not have been enrolled and instead should have been a screen failure. This person did not receive any study drug.
749392|NCT00688519||
749393|NCT00688467||
749394|NCT00688376|This study was conducted at 22 centers in the United States, France, Germany, the Netherlands, Spain, the UK, Argentina, Chile, and Australia during the period of 02 July 2008 to 26 May 2009.|This trial had three phases: (1)pre-randomization to establish eligibility; (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose escalation based on body weight; (3) a 12-week, blinded extension phase during which all participants received active drug. Eligible participants were randomized to receive placebo or donepezil.
749395|NCT00688324||There were 39 subjects who signed consent for the study. Three subjects were excluded prior to entering the study: two subjects refused to continue and one subject was hospitalized. Thirty six subjects entered the first phase of the study.
749396|NCT00688259||122 individuals consented for study; 34 did not meet study criteria after more careful screening during baseline phase or withdrew before baseline assessments were completed; Remaining 88 were randomized.
749397|NCT00688155||
749398|NCT00688103||
749399|NCT00688064|Recruitment period: 18 AUG 2008 to 14 NOV 2008 in thirty-five centers (30 in the USA and 5 in Canada) public or private practices. Twenty-five USA centers and four Candadian centers used a central IRB, and the others used a local IRB.|
749400|NCT00687973||
749401|NCT00687908|Recruitment period: 12 NOV 2008 to 09 FEB 2009 in thirty-four centers (29 in the USA and 5 in Canada) public or private practices. Twenty-four USA centers and four Candadian centers used a central IRB, and the others used a local IRB.|
749402|NCT00687856||
749403|NCT00687830||
749404|NCT00687804||Participants who completed the 12 month randomized core study CRFB002D2301 were eligible to participate in the 24 month open-label extension study CRFB002D2301E1. The reporting groups for the participants in the extension study are according to their assigned treatment groups in the core study.
749405|NCT00687739||
749406|NCT00687713||
749407|NCT00687674|Thirteen (13) participants were recruited at Mayo Clinic between August 2008 and March 2010.|This was a phase I/II trial. A total of 13 participants were accrued, all to the phase I portion. This trial was terminated due to study design and toxicity during the phase I; therefore, the phase II portion will never open. No results from the phase II portion are available.
749408|NCT00687609|The study was discontinued early owing to difficulties in recruiting the target sample after seven patients had been recruited. Therefore, only disposition, demographic, and safety data are reported.|
749409|NCT00687544||
749410|NCT00687531||
749411|NCT00687453|Recruitment from Sep 2002 to Dec 2008. Subjects recruited from a diabetes specialty referral clinic, as well as from primary care clinics and through advertising in the South Los Angeles area.|"Baseline run-in period to document baseline control and reinforce dietary/lifestyle principles.
~3 subjects not randomized due to protocol violations."
749412|NCT00687440||
749413|NCT00687401||
749414|NCT00687362||
749415|NCT00687323||
749416|NCT00687297||
749417|NCT00687271||
749418|NCT00687219||
749419|NCT00687193||
749420|NCT00687167||
749421|NCT00687102|Co-STAR enrolled 1,498 women assigned in the STAR trial aged 65 years and older and no diagnosis of dementia. All participants were fluent in English and provided written informed consent for the Co-STAR study. Enrollment began in October 2001, 18 months after STAR enrollment started and continued until the unmasking of STAR in June 2006.|
749422|NCT00687076||
749423|NCT00686998|A total of 2 centers in the US were initiated and enrolled patients. 159 patients enrolled, of which 106 randomized|Patients were screened up to 21 days, and admitted to the Clinical Research Unit (CRU) for a maximum of 2 days until eligibility was determined. Once eligibility was determined, patients currently on medication entered a 7 days washout period, patients not currently on medication had a 3 day washout, prior to randomization to study medication.
749424|NCT00686972||
749425|NCT00686959||
749426|NCT00686920|"A total of 152 (47%) participants with hepatic encephalopathy (HE) rolled over from the double-blind study RFHE3001 (NCT00298038); 70 rifaximin participants (designated to the Continued Rifaximin arm in Study RFHE3002) and 82 placebo participants (designated to the New Rifaximin arm along with the new 170 [53%] participants in Study RFHE3002)."|
749427|NCT00686894||
749428|NCT00686881||
749429|NCT00686855||
749430|NCT00686842||
749431|NCT00686829|Participants with human immunodeficiency virus (HIV) infection enrolled in AIDS Clinical Trial Group (ACTG) study A5211 (NCT00082498) and (1) completed the 48-week phase, or (2) had detectable alpha-chemokine receptor 4 (CXCR4)-tropic virus but maintained a virologic response and no drop in cluster of differentiation 4 (CD4)/CD8 count from baseline, or (3) met all inclusion/exclusion criteria but were unable to enroll in ACTG A5211 due to protocol closure prior to their randomization and dosing.|
749432|NCT00686803|Initiation Date: 28 April 2008 Completion Date: 21 July 2008 Cohort 1: 6 subjects: PL-3994 0.3 µg/kg; 1 subject Placebo Cohort 2: 6 subjects: PL-3994 0.1 µg/kg; 1 subject Placebo Cohort 3: 6 subjects: PL-3994 0.3 µg/kg; 1 subject Placebo; Study stopped after Cohort 3.|Some results (i.e.Pharmacodynamic results) may include analyses only for the Evaluable Subjects population.The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK or PD parameters were possible.
749433|NCT00686790||Of the enrolled participants, 19 received no study medication and 1 was not eligible. The Intent-to-Treat (ITT) population is 48.
749434|NCT00686777||Participants could be discontinued from study by meeting prespecified AE discontinuance criteria defined in the protocol. Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL
749435|NCT00686725||
749911|NCT00663234|Recruitment occurred between August 31, 2009 (date first participant enrolled) and December 16, 2013 (date last participant enrolled).|
749436|NCT00686712|Recruitment occurred from Sep 2002 to Feb 2009. Subjects recruited from a diabetes specialty referral clinic, as well as from primary care clinics and through advertising in the South Los Angeles area.|"Baseline run-in period to document baseline control and reinforce dietary/lifestyle principles.
~23 subjects not randomized due to protocol violations, loss to follow-up, lack of need for insulin, or voluntarily."
749437|NCT00686699||
749438|NCT00686686||
749439|NCT00686647||
749440|NCT00686634||
749441|NCT00686595||48 participants were enrolled in this study. Of these, 38 participants received at least one dose of the study medication and represent the intent-to-treat (ITT) population.
749442|NCT00686582||
749443|NCT00686543||
749444|NCT00686517||130 participants were randomized to pegylated-interferon alpha-2b at the dose of 1.5 mcg/kg/week for 24 weeks (PEG-IFN 24), pegylated-interferon alpha-2b at the dose of 1.5 mcg/kg/week for 12 weeks (PEG-IFN 12), or pegylated-interferon alpha-2b at the dose of 1.5 mcg/kg/week + ribavirin at the dose of 10.6 mg/kg/day for 12 weeks (PEG-IFN + RVB 12).
749445|NCT00686374||36 participants discontinued study drug when adalimumab became commercially available (received regulatory approval for pediatric Crohn's disease) in their country. These participants were considered to have completed the study, and are included as study completers in the subject disposition.
749446|NCT00686335|Asthmatic patients, aged at least 18 years, suffering from severe persistent asthma, having nocturnal symptoms and receiving treatment with oral glucocorticoids were recruited from Hôpital Bichat between July 2008 and March 2010.|After a 4-week run-in period in which patients were treated with immediate release prednisone (Cortancyl®) administered in the morning, all eligible patients (based on inclusion/exclusion criteria) were treated for 4 weeks with an identical dose of Lodotra administered in the evening.
749447|NCT00686257||
749448|NCT00686231||
749449|NCT00686205|"21606 donors enrolled from 6 geographically distinct blood donor and 1 plasmapheresis center. All donors were eligible if they signed a study consent form.
~In addition, 1388 specimens positive for HIV antibodies and 1117 specimens from US individuals at increased risk of HIV infection or from an HIV-2 endemic area."|All subjects were assigned to one group. There was no pre-screening criteria specific for this study.
749450|NCT00686166||
749451|NCT00686127||
749452|NCT00686075|A total of 720 participants were randomized in the study. An additional 618 participants were screened but not randomized in the study.|
749453|NCT00686036|A total of 25 male patients signed informed consent at 12 centres in Canada between May 2008 and February 2010. Out of these 25 patients, 17 patients were randomized with 9 patients in the vandetanib treatment arm and 8 patients in the placebo arm.|To be eligible for enrollment into the study, patients had to have received treatment with ADT for 36 weeks (± 4 weeks), with a pre-ADT PSA ≥ 5 ng/mL. Also, they should have had a screening PSA ≤ 1.0 ng/mL (within 6 weeks prior to study Day 1)
749454|NCT00685945|Subjects were recruited from a volunteer registry at Vanderbilt University. Subjects who participated in prior studies and requested to be contacted for future studies were included in the recruitment process. Recruitment began on 12/07 and stopped on 1/09.|Subjects with renal, endocrine, hematological or cardiovascular disease (including hypertension defined as an untreated systolic/diastolic blood pressure greater than 140/90 mmHg were excluded. Subjects with a fasting cholesterol greater than 5.7 mmol/L (220 mg/dl) and smokers were excluded. No washout period was required for the study.
749455|NCT00685932|July 2008 to March 2010|
749456|NCT00685880|Subjects were recruited from the pool of referrals to the Mayo Hand Clinic who are interested in receiving an injection for their pain, agree to comply with the standardized hand therapy program, meet the inclusion/exclusion criteria and are able to make the scheduled follow-up visits from Mayo 2008 to July 2010.|
749457|NCT00685802|Thirty-two healthy adult male and female volunteers from the community-at-large were enrolled.|
749458|NCT00685763||
749459|NCT00685750||
749460|NCT00685698|Patients were assessed during the 1- to 2-day screening phase (Visit 1) to determine their eligibility. Eligible patients demonstrating the presence of at least one Gram-positive organism on the basis of Gram-stain could begin treatment with study medication the same day (Day 1, Visit 1).|
749461|NCT00685685||
749462|NCT00685659|We enrolled 332, but 11 of those were pilot participants assigned to receive the Telephone Monitoring and Counseling plus vouchers. They were not randomly assigned participants and their data was not included in the final analyses.|
749463|NCT00685516||
749464|NCT00685477||
749465|NCT00685399|This is a multi-center study which comprised of 6 cohorts. This study was a proof of concept study.|
749466|NCT00685373||This study included participants previously enrolled in CACZ885A2102 (NCT00487708), CACZ885D2304 (NCT00465985) and ACZ885 naive patients.
749467|NCT00685334||
749468|NCT00685295||
749469|NCT00685178||250 volunteers were consented and admitted into the study; however 171 were randomized into the study. 79 volunteers were excluded due to a variety of reasons including failure to attend, adverse events (not study related), incarceration, failure to comply with study procedures, insufficient cocaine positive urines, and pregnancy
749470|NCT00685165||
749471|NCT00685139||
749472|NCT00685035|Potentially eligible patients were identified by query of the Minnesota CF database based on age and FEV1. This list was then reviewed and patients who met additional eligibility requirements were contacted by phone or recruited during a clinic visit by one of the study investigators. Enrollment was completed between 6/1/08 and 10/31/08.|
749473|NCT00684996||
749474|NCT00684983|Total of 68 (Arm A:20, B: 48) patients were accrued, 8 safety cohort patients from arm B are not eligible for primary end point analysis. There were 3 cancels (Arm B), 1 ineligible (arm A) and 1 major violation (Arm B, this patient is included in the primary analysis per protocol). Total of 64 patients started and completed the treatment.|
749475|NCT00684814||
749514|NCT00683592|Recruitment period was 31Mar2008 to 10Feb2009.|This study included a washout period to allow patients to discontinue their current antidepressant medications and any additional medications prohibited by the protocol, if applicable.
749515|NCT00683475||
749476|NCT00684788|Volunteers were recruited from detoxification programs in Baltimore, MD and through street outreach between October, 2006 and April, 2008.|Participants were required to complete opioid detoxification and were invited to attend the therapeutic workplace for induction onto oral naltrexone. During induction, participants were required to take scheduled oral naltrexone doses to gain access to the therapeutic workplace. Induction continued until three consecutive doses were ingested.
749477|NCT00684775||
749478|NCT00684762||
749479|NCT00684749|Surgeons recruited their own patients in their own offices|as above.
749480|NCT00684723||
749481|NCT00684671||
749482|NCT00684645||
749483|NCT00684593||
749484|NCT00684567||
749485|NCT00684554|Twenty patients were recruited between December 2007-June 2008 through referrals from clinical and research groups at Columbia University Medical Center and locally posted flyers.|After a structured telephone interview, participants completed in-person screening after obtaining informed consent. Of the 21 patients screened, one was excluded for active alcohol and benzodiazepine dependence.
749486|NCT00684541||
749487|NCT00684515||
749488|NCT00684424|Subjects were recruited from 36 medical centers and participated in the study between 11 July 2008 and 30 March 2009.|
749489|NCT00684411|12 participants were enrolled between August 2008 and December 2011.|
749490|NCT00684320||
749491|NCT00684307|The study population included male and female participants >18 years of age with chronic non-valvular Atrial Fibrillation. The participants were recruited during the time period from 20 February 2007 to 5 June 2008 at medical clinics in Europe.|Participants were enrolled in the study up to two weeks before randomisation and treatment assignment. Participants that were already treated with Vitamin K Antagonists (VKA) at the time of enrollment had their dose adjusted to achive INR <2.0 at the time of randomisation. If this was not achieved the participant was discontinued from the study.
749492|NCT00684255|Study closed due to low accrual.|
749493|NCT00684242|Recruitment Period: May 22, 2008 to November 1, 2010. All recruitment done at UT MD Anderson Cancer Center.|One participant was enrolled but excluded from the trial before assignment to groups.
749494|NCT00684203||Of 120 participants enrolled and randomized to treatment, 117 participants were treated with study drug. 92 participants underwent percutaneous coronary intervention (PCI) and 25 did not.
749495|NCT00684177||A total of 508 participants were randomized. One participant did not receive treatment; thus, no data were collected for this participant. Only 507 participants were included in the analysis.
749496|NCT00684138|Only adult subjects of either gender or any race in need of cataract extraction in both eyes were considered for enrollment. 280 subjects were implanted bilaterally with either the ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 or the ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 based upon a 1:1 randomization.|Subjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.
749497|NCT00684073||60 subjects who started selection were the number of subjects who attended the selection visit and signed informed consent
749498|NCT00684060|Enrollment took place at five Network centers and their associated satellite facilities between July 8, 2008 and February 28, 2011. The main centers are located in Ohio, Texas, Florida, Minnesota, and Tennessee. Study brochures, patient informational DVDs, and clinical trials.gov were among the tools used for recruitment.|
749499|NCT00684047|Study Initiation Date: 20 October 2008 Study Completion Date: 05 May 2014|
749500|NCT00684021|Enrollment took place at five Network centers and their associated satellite facilities between July 2008 and November 2011. The main centers are located in Ohio, Texas, Florida, Minnesota, and Tennessee. Study brochures, patient informational DVDs, and clinical trials.gov were among the tools used for recruitment.|
749501|NCT00683930||
749502|NCT00683917||
749503|NCT00683904||After all participants in Dose Level 1 (ixabepilone, 32 mg/m^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2 (ixabepilone, 32 mg/m^2 + carboplatin, 6 mg/min/mL) opened.
749504|NCT00683878|Of 972 participants enrolled, 558 completed a qualification period. Before entering lead-in period, 344 participants entered dose optimization period and 263 completed. A total of 480 participants entered the lead-in period, 420 randomized and received treatment, 367 completed double-blind treatment period.|
749505|NCT00683852|23 U.S. sites enrolled 225 patients over 10 months. 221 patients are included in the analysis. Enrollment began in September, 2008 and completed in July, 2009.|Patients completed a SAFER interview before randomization. No other significant events occurred prior to randomization.
749506|NCT00683826|Recruitment was completed. All subjects were recruited from the surrounding neighborhood and affiliates of Columbia University Medical Center (CUMC).|
749507|NCT00683800||A total of 3784 participants were screened, of which 1598 participants were screen failures and 2186 participants were randomly assigned to treatment.
749508|NCT00683787||
749509|NCT00683774||
749510|NCT00683696||After enrollment, baseline eligibility criteria were assessed (e.g. ventricular dyssynchrony, NYHA, QRS width, etc.) to qualify for implant. 1680 subjects were enrolled. 825 subjects did not qualify for implant and were exited from the study. 855 subjects qualified for implant. 821 subjects were successfully implanted. 809 subjects were randomized.
749511|NCT00683657||218 subjects were enrolled and 128 entered the 4-week dietary and exercise, and metformin extended release (XR) lead-in period. Thirty-five subjects did not enter treatment period (21 no longer met study criteria, 7 withdrew consent, 7 for poor protocol compliance).
749512|NCT00683644|recruited from audiology clinic in otolaryngology department|
749513|NCT00683618|In total 934 patients were enrolled to the study, the study was conducted at 13 investigational sites in China. The first patient was enrolled on 27 May 2008, the last patient was completed on 16 Jul 2009.|There is a dietary lead in period before randomization. 934 patients started the dietary lead in period. 436 patients completed this period. The baseline measurement is based on the ITT population. Patients included in ITT population in each arm is : Rosuvastatin 5mg 136, Rosuvastatin 10mg 139 and Atorvastatin 10mg 139.
749516|NCT00683449|Upon presentation to the Emergency Department (ED) at a hospital participating in the study with an acute exacerbation of asthma, the Principal Investigator (ED physician) discussed the study with the potential subject.|Some subjects were consented for the study, but upon screening, failed to meet the inclusion and exclusion criteria, had an FEV1 > 50%, or refused to participate.
749517|NCT00683410||
749518|NCT00683384||
749519|NCT00683332||
749520|NCT00683293|2008 to 2011 All patients were recruited from our clinic|
749521|NCT00683163|Recruitment letters were sent to women in the San Francisco Bay Area. Telephone screening interviews were conducted and study visits were performed at the San Francisco UCSF's Mt. Zion Medical Center.|Approximately 33,000 recruitment letters were mailed to women in the San Francisco Bay Area. Approximately 1100 phone calls were fielded, and 226 women were interested and eligible for additional screening. Of 164 who attended screening visits, 44 were eligible and enrolled.
749522|NCT00683085|Neighboring research hospitals around Tokyo, Japan sent three candidates to our hospital during May, 2008 to March, 2009.|Wash out time was four weeks from preceding therapy, and three candidates were evaluated for eligibility. Two cases were compatible to our eligibility, but another candidate was excluded from this study entry because he was not expected to survive more than three months.
749523|NCT00683046||
749524|NCT00683020|The study sample was drawn from San Francisco Health Plan The study sample was drawn April 2009 - March 2011 from San Francisco Health Plan (SFHP) members who received primary care at one of four publicly-funded clinics in the Community Health Network of San Francisco (CHNSF).|SFHP members deemed eligible were English-, Cantonese-, or Spanish-speaking adults (age 18 or above) with ≥1 primary care clinic visit in the preceding 24 months, had diabetes diagnosis, and access to a touch-tone phone. Members who were pregnant, unable to provide verbal consent, or leaving the region in the next 12 months were ineligible.
749525|NCT00682929|Recruitment period began in April 2004 and continued through 2016. Subjects were recruited from the UC Davis Neurology Clinic and through self-referrals.|
749526|NCT00682890|All recruitment and testing conducted at VCU General Clinical Research Center from August 2006 to December 2009|Following enrollment but prior to group assignment 5 subject were excluded based on screening results. Randomized remaining 23 subjects.
749527|NCT00682851||
749528|NCT00682838||
749529|NCT00682786|Enrollment to the study opened on 10/07/2002 and the study closed to enrollment on 10/23/2008.|
749530|NCT00682734||
749531|NCT00682643||
749532|NCT00682617||
749533|NCT00682565||
749534|NCT00682539|Study patients were recruited between 2007 and 2014 at the outpatient clinic of the Department of Ophthalmology, Medical University Vienna, Austria.|
749535|NCT00682461|Participants were recruited at one clinical site in the US.|
749536|NCT00682435||
749537|NCT00682357||
749538|NCT00681889|Patients were recruited from the Cornea Service at the Massachusetts Eye and Ear Infirmary from April 2008 through September 2009.|Participants were assigned to the investigational treatment upon a full eligibility screening. Participants were not eligible if they had received investigational therapy within 60 days, received treatment with anti-VEGF agents (intraocular or systemic) within 45 days, were concurrently using systemic anti-VEGF agents amongst other criteria.
749539|NCT00681863||
749540|NCT00681824|Participants were enrolled at 12 United States and 1 Canadian clinical site(s) beginning May 2008 and completing in March 2010|95 were enrolled. 23 discontinued (10 screen failures, 3 withdrawn by investigator, 3 withdrawn by representative or self, 1 died- failure to thrive, 1 had surgery before randomized, 1 study site distance, 1 site reached enrollment goal, 2 patients cancelled surgery, 1 family delayed >30 day window. 62 randomized. There were 13 run-in participants.
749541|NCT00681811|Children with an established diagnosis of late metachromatic leukodystrophy (MLD) due to arylsulfatase A (ASA) deficiency were recruited.|All participants who completed Study HGT-MLD-048 (NCT00633139) participated in this study.
749542|NCT00681668|Study period July 2007 to October 2008; Medical Clinic - Westfälischen Zentrums Herten; Psychiatrie and Psychotherapie|
749543|NCT00681629|Study period July 2008 to November 2008; Centre Dr. Lambert (Hamburg), Centre Dr. Dorn (Berlin)|
749544|NCT00681590||
749545|NCT00681564|rom April 2008 to March 2011 three hundred and six subjects were assessed for eligibility to participate in this randomized clinical trial. One hundred and two patients were randomized to the control (n=55) and treatment group (n=47). At 12 weeks of follow-up, 47 patients (control group) and 41 patients (treatment group) completed the study.|Two hundred and four patients were excluded from this study for the following reasons: no fulfillment of inclusion criteria (n=183), refusal to participate (n=4), not assistance to study appointments (n=15), and another reasons (n=2).
749546|NCT00681538||Only those subjects who were deemed responders to Sativex from Phase A (i.e. at least a 20% reduction in mean 0-10 point numerical rating scale (NRS) spasticity score between screening and the end of the four week Phase A treatment) were eligible to enter Phase B of the study.
749547|NCT00681473|A large number of patients with brain tumors in the greater area are referred to one or more of the MGH multidisciplinary brain tumor specialists for evaluation and further care.|
749548|NCT00681291|First subject was enrolled on April 11, 2008 and last subject was enrolled on February 12, 2010.|
749549|NCT00681265|Dates: 5/18/2008 to 8/30/2008. Single site: Flaum Eye Institute at the University of Rochester.|
749550|NCT00681187|Data from ninety-four subjects was reviewed in hospital clinics in Denmark, Norway and Sweden. Of which 32 were ineligible, 36 were eligible but chose not to participate due to lack of motivation, satisfaction with current form of administration or fear of self-injection and 26 were included. Patients were recruited from Jun-08 to Jan-10.|
749551|NCT00681109||
749552|NCT00681083||
749553|NCT00681044|Patients were enrolled from the Boston Medical Center Stem Cell Transplant Program between 2006 and 2009.|A patient enrolled on this study but was withdrawn due to insufficient stem cell yield. His clinical situation changed 5 months later and the investigators believed he would have a better yield so he was enrolled for a second time. Therefore, there were 5 enrollments, but 4 patients.
749554|NCT00681031||
749636|NCT00676793||
749555|NCT00680992|Adults and skeletally mature adolescents (≥12 years of age) were enrolled in this open-label single-arm study. The study was conducted at 30 centers in North America, Europe, and Australia from 09 Sep 2008 to study completion on 17 May 2018. The planned study duration for each participant was at least 60 months (following protocol amendment 7).|3 participants from study 20040215 (NCT00396279) were enrolled directly into safety follow-up phase without retreatment. They were excluded from all defined analysis sets and results are reported for the 532 participants enrolled into the treatment phase. Non-completion reasons are summarized for the on-study period (ie, initial treatment phase).
749556|NCT00680953||
749557|NCT00680914||
749558|NCT00680901||
749559|NCT00680862||
749560|NCT00680836||
749561|NCT00680823||
749562|NCT00680797|Recruitment methods included flyers and advertisement in local newspapers. Healthy Veteran and community participants who responded to to advertisement were screened by telephone for exclusion criteria. If no exclusion criteria were reported, participants were scheduled for a screening history and physical.|
749563|NCT00680771|Pre-menopausal women aged 25-50 with either Primary Insomnia (PI) or Good Sleep (GS) were recruited from posters, flyers, and newspaper advertisements in the Rochester, NY region during the period of 2008-2010.|There were two study groups, but this did not involve random assignment. Group assignment to either Primary Insomnia or Good Sleeper was based on subjective (sleep diaries and validated instruments)and objective (polysomnography) measures of sleep. Twenty-eight subjects were enrolled.
749564|NCT00680745|Enrollment: 859 (597 randomized and 592 in the Full Analysis Set) Study Start Date:April 2008 Study Completion Date:May 2010 Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)|Reasons for enrolled participants not being randomised: 229 incorrect enrollment, 4 adverse event, 23 withdrew consent, 2 lost to follow up and 4 other.
749565|NCT00680706|Recruitment: January 2008 to February 2010 Location: Emergency Department|One subject was dropped by the PI after consent but before randomization because the subject did not meet the inclusion/exclusion criteria.
749566|NCT00680628|Patients enrolled from 8 hospitals from August 2008 until October, 2012. Genentech funded the study. Carolinas Medical Center was the prime contractor site and subcontracted 7 other hospitals.|The investigator relocated to a new institution in July 2012, which led to insoluble problems with the subcontracts that forced early study closure.
749567|NCT00680524||
749568|NCT00680459||
749569|NCT00680407|Patients were recruited at 5 sites; first observation April 30, 2008, last observation Nov 12, 2012.|
749570|NCT00680368||
749571|NCT00680316||
749572|NCT00680225||
749573|NCT00680186|There were 2589 patients enrolled/randomised but only 2568 were treated.|
749574|NCT00680121||
749575|NCT00680056|University clinic Period: January-August (2008)|"After screening and before first baseline visit, patients discontinued long-acting β2-agonists and inhaled anticholinergic bronchodilators (run in period).
~50 patients recruited; 33 screened. 7 excluded: 4 due to chronic obstructive pulmonary disease (COPD) exacerbation and 3 due to protocol violation."
749576|NCT00680043||
749577|NCT00680017|280 participants were randomized and treated at 84 sites in the United States and Puerto Rico between 23 July 2008 and 02 March 2011.|
749578|NCT00679952||
749579|NCT00679939||
749580|NCT00679926|Recruitment was July 2009 to January 2011 and was completed at the Internal Medicine Specialty Clinic at OSU-CHS.|There are no significant events prior to enrollment. Patients had to be naive to HIV therapy prior to treatment drug.
749581|NCT00679913|Between June 2006 and November 2009, 244 patients were enrolled in this study, after excluding the 9 patients who refused to participate after initial agreement. After enrollment, 44 patients were excluded due to having unresectable or metastatic tumors, as determined intraoperatively|After enrollment, some patients were excluded due to (1) unresectable condition or metastasis found during surgery; (2) surgical rule violation; (3) inadequate case report form; or (4) pathologic diagnosis other than conventional ductal adenocarcinoma.
749582|NCT00679783|The first patient was enrolled on July 8, 2008 and efficacy and safety data were collected up to the data cut-off of March 26, 2010. Patients were enrolled at 6 centres in Canada. Of the 112 patients who gave informed consent 21 patients failed eligibility criteria or withdrew their consent and were not allocated to treatment.|The study enrolled both known BRCA mutation carriers and patients with unknown BRCA status. Those with unknown status at entry had to provide a DNA sample for BRCA. One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis. Study data are summarised by confirmed mutation status.
749583|NCT00679627|This study investigated the benefits and risks of long-term galantamine use in participants with Alzheimer's Disease. The study was conducted from 19 May 2008 to 20 May 2012 at 127 clinical centers in 13 countries. A total of 2051 participants were randomized to study treatment, of these 2045 received at least 1 dose of treatment.|The Data Safety Monitoring Board (DSMB) recommended that the study be terminated early because of an imbalance of deaths between the treatment groups.
749584|NCT00679549|150 patients provided the baseline measurements and were randomized and included in the trial.|
749585|NCT00679432|Recruited from August 2008 until May 2010.|Diary data for symptoms will be collected prior to randomization. Lab testing and a colonoscopy will be done prior to randomization. 510 patients were randomized. One patient was not treated and was not included in baseline characteristics, efficacy, and safety analyses. 509 patients received study drug and were included in safety analyses.
749586|NCT00679380|Recruited from July 2008 to February 2010.|3 randomized patients were not treated and are excluded from all analyses. The safety population, N= 511: 509 randomized and treated + 2 nonrandomized and treated patients. The intent-to-treat (ITT) population, N=410: 511 - 101 patients who were not randomized, had major entry criteria violation, GCP violation, or normal histology at baseline.
749587|NCT00679367||
749588|NCT00679354||
749589|NCT00679341||
749637|NCT00676780|Patients were recruited from the urology clinic at LSU Health, Shreveport during the period of May 1, 2004 and February 20, 2008.|Exclusion criterias were determined before enrollment process.
749638|NCT00676715||Total 220 participants were randomized, out of which 218 participants received study treatment.
749639|NCT00676689||
749590|NCT00679302|Patients >3months and <18 years old with skin abscesses who are not immunocompromised, or in 3rd trimester of pregnancy were approached to participate in the study, or allergic to trimethoprim/sulfamethoxazole.|Enrolled participants were only excluded from the trial before assignment to groups if they left the emergency department prior to receiving the medication/placebo and further instructions.
749591|NCT00679289||
749592|NCT00679263|Subjects diagnosed with moderate to severe asthma in stable status were recruited at clinic|Subjects were screened for eligibility and must have demonstrated an improvement in forced expiratory volume in 1 second (FEV1) of at least 12% and 200 cc at the Screen Visit after bronchodilator treatment compared to pre-bronchodilator use. Continued eligibility was determined for each subject prior to administering each dose.
749593|NCT00679211||Between 13 August 2008 and 2 April 2009, 110 patients from 44 study sites in the United States were enrolled and treated in the study.
749594|NCT00679172||
749595|NCT00679081||
749596|NCT00679055||
749597|NCT00679029||
749598|NCT00678899||
749599|NCT00678886|This study was conducted at 85 centers in 9 countries namely Canada (4), Germany (3), Denmark (1), Spain (5), Finland (2), United Kingdom (4), Italy (8), Sweden (11) and United States of America (47) from 29 July 2008 to 31 January 2012. A total of 240 participants with new-onset Type 1 diabetes mellitus (NOT1DM) were planned to be enrolled.|Participants were screened for a period of 35 days and a total of 272 participants were randomized in the study.
749600|NCT00678834||
749601|NCT00678795||
749602|NCT00678691|Subjects were easily recruited and screened for study entry|Subjects were exluded after informed consent if medical confounding variables or safety variables were found
749603|NCT00678652|Subjects recruited from CTC database if they have asked to be informed about upcoming studies. Posters//flyers, tv, internet, newspaper ads and word of mouth to recruit healthy subjects. Recruitment may include oral presentations and/or distribution of approved recruiting materials.|
749604|NCT00678639|Participants were recruited from the emergency department January 2008 - March 2009.|Once consented, no participants were excluded from the trial prior to group assignment.
749605|NCT00678587||
749606|NCT00678574|45 subjects were recruited at an outpatient practice at Yale University, CT.|
749607|NCT00678561|During the study, enrollment into the 4 once daily dosing regimen treatment groups was discontinued in order to decrease the overall total number of participants to be enrolled.|
749608|NCT00678535|First/last participant (informed consent): June 2008/December 2010. Clinical data cut-off: 31 March 2012 Study completion 17 February 2013.|Enrolled: 1,191 screened for eligibility; 287 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 904 participants randomized.
749609|NCT00678470|Patients were recruited from our medical clinic as well as through flyers posted at other University of California at San Francisco sites.|Patients were required to have a 2 week washout from topicals and one month washout from any systemic agents.
749610|NCT00678444||
749611|NCT00678418||
749612|NCT00678392||
749613|NCT00678379||
749614|NCT00678301|At screening, the following steps occurred: check for inclusion/exclusion criteria, contraindications/ precautions, medical and vaccination history of the subjects and signing or thumb-printing informed consent forms.|Among 365 enrolled participants, 8 were not administered any study vaccine and hence were not considered as starting the study.
749615|NCT00678288|This study was conducted from 16 Apr 2008 to 26 Jun 2009 at 31 centers in 7 countries: France (11), Italy (6), Spain (5), Poland (4), Ireland (2), United Kingdom (2), and Austria (1). The planned enrollment was 120 subjects in the 2 treatment groups (60 subjects per group). The study was stopped early because of slow accrual.|A total of 24 subjects were screened; 16 were enrolled and randomized; 10 (63%) to sorafenib alone and 6 (37%) to sorafenib + interferon. All 16 randomized subjects received at least 1 dose of study drug and were included in the safety analysis population.
749616|NCT00678249||
749617|NCT00678210||
749618|NCT00678080||
749619|NCT00678041||This is a double blind 1:1 randomized trial
749620|NCT00678015||
749621|NCT00677924||
749622|NCT00677898||
749623|NCT00677833|Participants were recruited in 2 age-based Cohorts. Cohort 1=participants between 5-12 years of age, assumed to have some degree of immunity and at less risk for untoward outcome. After demonstration of successful treatment, safety and tolerability in Cohort 1, participants between >=6 months of age to <=59 months of age were enrolled in Cohort 2.|Participants were enrolled in 2 cohorts based on different age criteria. All participants in Cohort 1 met the age criteria where as 3 participants enrolled in Cohort 2 were slightly older than 5 years (by less than 2 months).
749624|NCT00677820|A total of 300 subjects were enrolled and randomized in the study between 09Jun2008 and 10Jun2008 at 3 sites in the USA.|
749625|NCT00677807|This is an extension study to core study stage 2: CQAB149B2335S (NCT00463567).|
749626|NCT00677690|2007-2008 - Rehabilitative Pulmonary ward|167 COPD patients were admitted.52 out of 167 did not meet the inclusion criteria.19 out of the remaining 115 patients refused to participate.13 out of 96 subjects subsequently dropped out due to acute exacerbation.Our definitive sample was therefore of 83 subjects
749627|NCT00677534||
749628|NCT00677365||
749629|NCT00677352|Participants were screened at 34 centers in Japan.|Subjects who experienced at least one panic attack that met the DSM-IV diagnostic criteria per week between the start of the washout/observation period and the start of the double-blind treatment period and who had a total score of 18 or higher on the Panic and Agoraphobia Scale at the start of the double-blind treatment period.
749630|NCT00677235||
749631|NCT00677092||
749632|NCT00677040||
749633|NCT00677014||1060 patients were enrolled. 46 patients were not implanted with a CRT-D: screening failures (27), withdrawn by physician/sponsor (15) or withdrew consent (4). 34 implanted patients were not randomized: screening failures (13), withdrawn by physician/sponsor (14), withdrew consent (4), LTFU (2), death (1), not properly randomized (3)
749634|NCT00676897||
749635|NCT00676806||One subject signed consent but did not receive a transplant, so was dropped from the study and was not assigned to either arm.
749641|NCT00676663|Participants took part in the study at 38 investigative sites in the United States, Canada, Czech Republic, Hungary and Russia from 13 June 2008 to 26 November 2012.|Participants with a diagnosis of metastatic breast cancer were enrolled equally in one of two treatment arms: exemestane 25 mg plus entinostat 5 mg or exemestane 25 mg plus placebo.
749642|NCT00676650||
749643|NCT00676585||
749644|NCT00676572||
749645|NCT00676520|Subjects are derived from the USA interventional cardiology population.|A sub-set of subjects was randomized to the DAPT portion of this study.
749646|NCT00676494||
749647|NCT00676455|Approximately 100 participants were to be enrolled, with approximately 50 of each type of metastatic disease. 50 participants with metastatic Liver tumors and 50 with metastatic Lung tumors.|
749648|NCT00676403||Subjects meeting entry criteria with a confirmed diagnosis of Restless Leg Syndrome completed a washout of medications if needed prior to starting a 7-day single-blind placebo run-in to identify and exclude placebo responders and to adapt subjects to take study drug 1-3 hours prior to bedtime. Of 218 subjects screened, 137 subjects entered.
749649|NCT00676364|The study was conducted at one site of a multi-site, academic, community emergency department. Children between the ages of five and 18 years of age were considered for enrollment into the study if they were seen in the emergency department (ED) and a physician order was placed for intravenous cannulation or labs to be drawn by venipuncture.|A convenience sample was utilized due to the availability of the research study coordinator who completed the enrollment from 7 am to 5 pm Monday through Friday. One participant was excluded from analysis due to ineligibility.
749650|NCT00676338||
749651|NCT00676208||
749652|NCT00676195||
749653|NCT00676182||81 participants were enrolled, but some did not participate or dropped out, leaving 75 participants who participated enough to collect data.
749654|NCT00676143|The study was conducted at 218 centers across the world. The study was terminated early by the sponsor on 06 August 2012. Enrollment had already been completed at the time of this decision. Participants who were still participating at that time were asked to complete an early withdrawal visit.|
749655|NCT00676130|We enrolled generally-healthy subjects with uncomplicated acute cellulitis from 6/2007 to 12/2011. Eligible subjects were adults and children presenting to EDs of 3 teaching hospitals in Boston, MA.|Each subject was assigned randomly to a treatment group by the institutions' research pharmacies. The research pharmacies had no knowledge of subjects' clinical characteristics. Treating (non-research) clinicians, research clinicians, coordinators, and subjects had no knowledge of the randomization sequence.
749656|NCT00676091||
749657|NCT00676065|In the LASS study, 59,510 women were recruited overall. Of these, 836 participants were excluded due to protocol violation (e.g. patient did not start OC use). Furthermore, 371 patients started treatment with non-oral contraceptives. These patients were followed-up but were not part of the per protocol Population (58,303 patients).|
749658|NCT00676052|This study was conducted across 79 centers: 30 in North America, 28 in Europe and 21 in International regions. The first participant first visit was on 16 May 2008 and last participant last visit was on 22 December 2008.|Out of the 963 participants screened for this study, 303 participants were screen failures and 79 participants were run-in failures. Therefore, a total of 581 participants were randomized out of which 5 participants did not receive any study medication, thus 576 participants were included in the intent-to-treat (ITT) Population.
749659|NCT00676026|Participants were recruited at an outpatient research facility located at Yale University in New Haven, CT.|
749660|NCT00676013|Patients were recruited from the Galveston Burn Unit following an acute burn injury that were diagnosed with 3rd degree burns. Study was active between 1997-2011.|Patients were enrolled before their surgical procedure. After consent was obtained. After the surgical site was identified, the site was randomized to receive the various skin products.
749661|NCT00675987||
749662|NCT00675948|The first subject was recruited on the 30th April 2002|
749663|NCT00675922|Patients admitted to Burn ICU with acute burn injury were eligible for recruitment|Patients consented were randomized to one or two of the treatment medications.
749664|NCT00675909|Enrollment November 2006-January 2010 from the Emergency Department at Seattle Children's Hospital|
749665|NCT00675792||
749666|NCT00675766|Recruitment took place from September 2005 to September 2010. The population consisted of young (40 years or less) and old (50 years or more) Human Immunodeficiency Virus infected and non-infected veterans within the Greater Los Angeles VA Healthcare System with additional recruitment from the Los Angeles community in order to meet project goals.|Recruited subjects who meet any of the following criteria were excluded prior to group assignment: Brain infection other than HIV; Brain neoplasm; neurosyphilis; traumatic brain injury with L.O.C>30 mins; current diagnosis of seizure disorder; current psychotic spectrum disorders; history of drug or alcohol abuse or dependence within the past year.
749667|NCT00675597||
749668|NCT00675584||
749669|NCT00675558|Patients referred to several Divisions of the Department of Surgery at New York Presbyterian Hospital.|
749670|NCT00675506||
749671|NCT00675441|Recruitment Period: 04/16/2008 to 12/01/2010. All participants were recruited at The University of Texas MD Anderson Cancer Center medical clinics.|
749672|NCT00675428||This record includes data up to and including the last data values collected during long-term follow-up (27 January 2010).
749673|NCT00675415||
749674|NCT00675259||
749675|NCT00675103||
749676|NCT00674986||770 patients were screened. 522 patients were enrolled in the study. 23 patients at 1 site used the incorrect self monitored blood glucose device and were excluded. 499 patients met inclusion/exclusion criteria and were included in the analyses.
749677|NCT00674973||
749678|NCT00674817|This study was conducted from 25Apr2008 to 19Oct2008 across two centers in Thailand and one center each in the United Kingdom and New Zealand. A total of 45 participants were planned to be enrolled.|A total of 44 participants were screened over period of 28 days and were enrolled in the study.
749679|NCT00674765||
749680|NCT00674739|Recruitment period from June to December 2008 from 30 clinical study centers in the USA|
749681|NCT00674700|First Patient First Visit 12 OCT 2007, Last Patient Last Visit 01 FEB 2010|
749682|NCT00674661||
749683|NCT00674622|Recruitment took place between 3/17/2008 to 3/15/2010. All patients were seen at the University of Pittsburgh Medical Center outpatient clinics.|"105 subjects completed informed consent.
~38 subjects were ineligible, based on absence of diagnosis of lateral epicondylitis, insufficient severity of symptoms, or presence of an exclusion.
~1 subject completed all assessments but declined participation and was not randomized."
749684|NCT00674609||
749685|NCT00674583||During the screening the following steps occurred: check for inclusion/exclusion criteria,contraindications/precautions, medical history of the subjects and signing informed consent forms.
749686|NCT00674570||Participation involved 4 study visits, with randomization to intervention arm and drug administration occurring on visit 3. The discrepancy between 111 participants who were initially enrolled and 106 at randomization resulted from 5 participants who dropped out between screening and visit 3, when they were to have been assigned into a group.
749687|NCT00674492||
749688|NCT00674479|51 participants received study medication.|
749689|NCT00674466||
749690|NCT00674362|The study started in June 2008 with subjects from Germany, France, Austria, Italy, and Poland. The primary completion date occurred in May 2010, with an anticipated study completion in December 2010.|
749691|NCT00674323||
749692|NCT00674297|4 groups were recruited: primary antiphospholipid syndrome(PAPS); systemic lupus erythematosus (SLE) with antiphospholipid syndrome(APS)(SLE/APS); persistent aPL positivity without SLE/APS(Primary aPL); and persistent aPL positivity with SLE but no APS(SLE/ aPL). The frequency-matched control group was identified from a databank of healthy persons.|"SLE was defined based on the American College of Rheumatology classification criteria. APS was defined based on the updated Sapporo classification criteria.
~Positive aPL was defined as persistently (at least 12 weeks apart) positive LA test, aCL≥40 GPL/MPL and/or aβ2GPI≥20 SGU/SMU."
749693|NCT00674219|Participants were recruited during 2007-2008 from the Anxiety Disorders Program at UCLA.|
749694|NCT00674206||
749695|NCT00674154|We randomized 46 patients with PHPT and 25OHD-levels < 80 nmol/l to a daily supplement with 70 microgram (2800 IU) of cholecalciferol or identical placebo for 52 weeks. Accordingly, treatment was administered for 26 weeks prior to parathyroidectomy and continued for 26 weeks following surgical cure.|We screened 227 PHPT patients. A total of 46 patients were included.
749696|NCT00674128|Patients were recruited sequentially at a tertiary care medical center between 2 June 2008 and 19 February 2009.|33 patients did not meet inclusion criteria. 16 eligible patients did not consent. 103 patients were eligible and consented. 55 were assigned to Adhesive and 48 to Suture. The procedure was aborted for 5 patients in the Adhesive group and 4 patients in the Suture group.
749697|NCT00674115||60 participants were randomized to either 1-Day or 7-Day Dosing in this crossover study (participants in both groups received 1 treatment [Zegerid or Prilosec], followed by washout period, followed by the other treatment [Prilosec or Zegerid]). Participants in the 1-day dosing group also received sodium bicarbonate after a washout period.
749698|NCT00673959|20 Dry Eye Subjects|Randomized, double-masked, crossover
749699|NCT00673933||Two areas on the back per patient was treated, one area with Visonac and one with vehicle
749700|NCT00673920|Screening was completed within 28 days prior to randomization. This may have been extended by an additional 56 days, up to a maximum of 84 days, if washout from the respective disease modifying anti-rheumatic drugs (DMARDs) or if immunization was required.|
749701|NCT00673894||15 of 22 participants were randomized. Of those not randomized, 7 did not meet the inclusion criteria
749702|NCT00673881||
749703|NCT00673855|20 Dry Eye Subjects|Randomized, double-masked, crossover
749704|NCT00673816|The recruitment goal was to enroll five participants; however, the study was terminated after only two participants had been enrolled as a result of slow recruitment and adverse events. Date of enrollment of the first participant was December 10, 2008, and the study was terminated on December 1, 2010.|
749705|NCT00673790|May 2008 to March 2010 at 96 US sites, 72 sites randomized patients.|A losartan or lisinopril run-in phase was required for all patients before assignment to Placebo or Nebivolol or Hydrochlorothiazide arms.
749706|NCT00673764|48 Dry Eye Subjects|Randomized, double-masked, crossover
749707|NCT00673738|Participants were recruited at Moffitt Cancer Center from May, 2008 to November, 2010.|
749708|NCT00673712||
749709|NCT00673673||
749710|NCT00673660|This was an observational study evaluating compliance to statin treatment in participants with dyslipidemia. Data available at each visit was recorded in case report forms (CRFs). No laboratory measurements were performed. The gender of 2 subjects was not recorded.|
749711|NCT00673595|Participants were recruited at the Mayo Clinic in Rochester, Minnesota from March 2007 to February 2009.|
749712|NCT00673465|Part 1 was conducted in the United States. If an analysis at the end of Part 1 demonstrated that SCH 497079 exhibited a clinically significant glucose lowering effect, Part 2 was to be conducted in India. Part 2 of the study was not conducted.|
749713|NCT00673452||All patients were on duloxetine in the continuation phase. The continuation phase was for exploratory purpose only, and the results will not be presented further.
749714|NCT00673439||
749715|NCT00673400||
749716|NCT00673387|First participant dosed/lead in: 06 May 2008; last participant's final visit: 07 April 2009. Study conducted in 42 clinics in participants who were either obese (body mass index (BMI) greater than, equal to (>=) 30 kg/m^2 and less than equal to (<=) 45 kg/m^2) or overweight (>= 27 kg/m^2 and < 30 kg/m^2).|Participants enrolled, not randomized /treated (28): withdrew consent (10), adverse event (1), investigator decision (7), protocol violation (4), lost to follow up (5), administrative (1). 1 Week Lead-in Period: all arms received placebo matched to metreleptin and matched to pramlintide, BID (single blind); 28 week double blind Treatment Period.
749717|NCT00673361||
749718|NCT00673309|Patients admitted to burn unit with >40% burn or greater|Randomized to study drug or placebo/control
749719|NCT00673257||
749720|NCT00673244||
749804|NCT00669318|Forty-one patients were enrolled from July 2008 to February 2013 and 39 were evaluable. Two patients did not start treatment. One patient was found to have concomitant Hodgkin lymphoma and the other a serious systemic infection during pre-treatment evaluation. The characteristics of the 39 evaluable patients are summarized|
749805|NCT00669279||
749721|NCT00673231|First participant enrolled: 30 April 2008, Last participant completed 24 week period: 19 May 2009. 1240 enrolled at 126 centres in 13 countries. Men and women aged ≥18-≤80 years at time of consenting who have inadequate glycaemic control (HbA1c ≥7.5% and ≤10.5%) and are on a stable insulin regimen (≥30 IU of injectable insulin per day for 8 weeks).|For two weeks prior to randomization, participants recorded their daily self monitored plasma glucose and insulin use. At randomization, qualified participants were stratified according to their use of other anti-diabetic (OAD) medication or not. No more than 60% of enrolled participants were to take insulin plus OADs.
749722|NCT00673179|Recruitment period: May 05, 2008 to November 24, 2010. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.|Early study termination with low accrual.
749723|NCT00673153||
749724|NCT00673127|Medical oncology clinics|Required 6 week washout for any AR antagonists
749725|NCT00673114|Three patients enrolled.|
749726|NCT00673075|The recruitment period was April 2008 to May 2009 at 35 US locations.|All patients went through a 4-week, single blind, metoprolol run-in phase before randomization.
749727|NCT00673049||
749728|NCT00672984||This is a three period crossover trial.
749729|NCT00672958|Participants took part in the study at 47 investigative sites in the United States from 07 April 2008 to 12 November 2008.|Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 2 treatment groups, once a day placebo or 5 mg vortioxetine.
749730|NCT00672932||
749731|NCT00672854|The study was conducted at Grady Memorial Hospital, a major urban teaching hospital affiliated with Emory University and at Emory University Hospital, a tertiary referral academic institution in Atlanta, Georgia.|A total of 100 patients were randomized to either soybean oil-based (intralipid 20%) parenteral nutrition or olive oil-based (ClinOleic 20%) parenteral nutrition for up to 28 days. A total of 49 patients received soybean oil-based parenteral nutrition and a total of 51 patients received olive oil-based lipid emulsion in parenteral nutrition
749732|NCT00672841|Patients were recruited from June 2008 to December 2010 on three intensive care units.|
749733|NCT00672737|From January 2008 till March 2010, we invited male volunteers (18-55 years old) with a history of habitual snoring and/or a formal diagnosis of OSA to participate in a study evaluating sleep and experimental pain processing at the Human Pain Laboratory in the Department of Anesthesiology at Stanford University.|We screened 167 male volunteers; 56 consented to participate to the study.
749734|NCT00672646|"The study was performed at Lifetree Clinical Research, Salt Lake City, USA, during April-June 2008.
~135 participants enrolled in the study, 103 randomized and 99 patients completed the study."|Screening for eligibility prior to the residential day, and selecting the patients that request pain relief, due to pain from the dental surgical area, within 6 hours after the end of the administration of the local anaesthetic.
749735|NCT00672633|Patients were recuited from medical clinics at Boston Children's Hospital and referrals from community pediatricians. Recruitment took place from July 2008 to October 2011.|Eligible patients participated in a 4 week dietary counseling run-in period before randomization. Patients were randomized if their triglycerides remained at or above 150 mg/dl after the 4 week run in period.
749736|NCT00672620|Participants took part in the study at 47 investigative sites in the United States from 10 April 2008 to 30 December 2008.|Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, 2.5 mg, 5 mg vortioxetine, or 60 mg duloxetine.
749737|NCT00672594||
749738|NCT00672555|All patients meeting the inclusion criteria during the study recruiting period, who gave their consent included.|1 patient excluded because of mental handicap
749739|NCT00672490||
749740|NCT00672477||
749741|NCT00672451||5 Participants were not included in the study analysis or assigned to a group prior to termination.
749742|NCT00672438|Twins were recruited by a joint effort of SRI International and Stanford University School of Medicine. Initial contact and primary enrollment was the responsibility of study staff of SRI International. Recruitment was mainly achieved through the Twin Research Registry and advertisements broadcasted by regional radio stations|"Participants were required to fast overnight except for clear liquids that were allowed up to 2 hours before starting the drug infusion. Subjects were also required to have at least 6 hours of night-time sleep before a study session.
~Some participants withdrew prior to study participation."
749743|NCT00672256|community recruitment completed recruitment March 2009|enrolled participants would be excluded if they were unable to meet study requirements, or had scheduling issues.
749744|NCT00672243|Patients were enrolled between May 2007 and March 2008 at the Preston Robert Tisch Brain Tumor Center at Duke.|Patients were excluded for any of the following: prior therapy with either an EGFR or mTOR antagonist; uncontrolled intercurrent illness including active infection, symptomatic congestive heart failure, unstable angina, grade 3 or greater hyperlipidemia or significant gastrointestinal, renal or liver disease, pregnancy or nursing
749745|NCT00672204|Recruited from 2008 - 2009 at the University of Minnesota.|Raptiva was removed from market.
749746|NCT00672178|Recruitment: Jan 2008-Sept 2009. Study stopped early due to low accrual|
749747|NCT00672139|Patients participated in this study at sites in Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Spain, Sweden, the United Kingdom, and the United States.|The main eligibility criteria for this study were completion of 2 weeks of therapy and all post-baseline efficacy, safety, and health outcomes assessments in lead-in study MNTX4000 and an anticipated continued need for treatment of opioid-induced constipation.
749748|NCT00672100|"Patients were identified from the surgical schedule. Subjects consented using the most current IRB-approved consent form. Informed consent were administered in the pre-operative suites prior to receiving any treatment.
~Recruitment started after approval was obtained from the IRB. Recruitment period was Jan 2009 to Dec 2009."|Subjects were screened per protocol, those that met all inclusion criteria and did not meet any exclusion criteria were randomized per protocol.
749749|NCT00671970|Open for recruitment from February 2007 to May 2008. Subjects recruited in the Preston Robert Tisch Brian Tumor Center at Duke University Medical Center (DUMC).|
749750|NCT00671931|Enrollment has been completed for this study.|There is no wash out, run-in, or transition period in this protocol
749751|NCT00671918||
749752|NCT00671879||
749806|NCT00669240||
749807|NCT00669214||
749766|NCT00671060|This randomized trial was conducted at Montefiore Medical Center, Stanford University, Stroger Hospital, Christiana Care Hospital, the Huong Vuong Hospital in Ho Chi Minh City, Viet Nam. Women who sought medical care for possible fetal demise in pregnancies of between 14 and 28 weeks from December 2008 to December 2011 were screened.|No participants were excluded from the trial before assignment to groups.
749767|NCT00671034||
749768|NCT00670982|Patients were enrolled between May 2008 and March 2010.|
749769|NCT00670956|Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm|
749770|NCT00670930||
749771|NCT00670800|Volunteers between the ages of 21 - 40 years were recruited from reproductive endocrinology clinic and newspapers. Women were excluded according to protocol exclusion criteria (see protocol)|Some potential subjects were excluded due to results of an oral glucose tolerance test (OGTT).
749772|NCT00670774|Consecutive kidney transplant patients recruited between 1/6/2008 and 1/8/2010 were recruited at Mayo Clinic in Rochester, Minnesota.|31 subjects signed informed consent, but 5 patients were screen failures and did not start the study.
749773|NCT00670748||
749774|NCT00670709|Recruitment began September 2006 and ended in February 2008. All recruitment took place at UCLA Neurology Clinic and the UCLA Semel Institute.|
749775|NCT00670631||Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.
749776|NCT00670540||
749777|NCT00670488||A total of 104 participants were enrolled and received treatment in this study.
749778|NCT00670462||
749779|NCT00670449||
749780|NCT00670306||
749781|NCT00670267||
749782|NCT00670241||
749783|NCT00670228|Multicenter study: 60 out of the 90 centers planned were initiated. Only 17 centers randomized patients (i.e. 7 sites in the United States, 5 sites in Argentina, 3 sites in Brazil and 2 sites in Mexico).|Although 34 patients signed the informed consent form for study inclusion, one patient did not sign the Health Insurance Portability and Accountability Act (HIPAA) form, electing to keep his/her medical information private, and was therefore not randomized.
749784|NCT00670202||
749785|NCT00670111||Following enrollment, patients were had an exercise test to determine chronotropic incompetence (CI). If patients were not CI, they were deemed a Testing Failure and withdrawn from the study. CI patients that were then implanted with a pacemaker were randomized to the order of their Rate Adaptive Pacing therapy for the 2 one month exercise tests.
749786|NCT00670046||
749787|NCT00670007|"This multicenter study was conducted at 22 centers in Europe, Canada, and Australia.
~Alpha1-proteinase inhibitor (A1-PI) deficient individuals with emphysema, who had completed the 2-year treatment and observation periods in study CE1226_4001, except those participating in the USA, were invited to participate in study CE1226_3001."|Subjects who had participated in the CE1226_4001 study, met the inclusion and exclusion criteria, and signed the informed consent were included in study CE1226_3001.
749788|NCT00669955|First patient in: 11 June 2008 Last patient out: 22 June 2009 Patients were recruited from clinics and hospitals located in seven European Countries: Germany, Poland, Italy, France, Ireland, Spain, United Kingdom.|If patient was on any contraindicated medications, such as H2 antagonists, sucralfate, or proton pump inhibitors, a washout period of 2 weeks began following informed consent signature, and patient returned to the clinic to perform the endoscopy and the C-13 UBT. Presence of H. pylori needed to be confirmed by C-13 UBT and RUT at least.
749789|NCT00669942|Part 1: single dose escalation - sequential cohorts of patients and healthy volunteers received AIN457A or placebo. Part 2: multiple dose escalation - sequential cohorts of patients received 2 doses of AIN457A or placebo. Part 3: patients received 2 doses of AIN457 10 mg/kg (or the maximum tolerated dose) or placebo.|In parts 1 and 2, participants were randomized 3:1 to receive AIN457A or placebo. In part 3, participants were randomized 1:1 to receive AIN457A or placebo.
749790|NCT00669916||
749791|NCT00669903|A total of two US centers were inititated with first patient enrolled on 2 April 2008 and last patient completed on 4 November 2008. A total of 158 patients were enrolled with 100 patients allocated to randomized treatment.|Patients were to receive a stable dose of an antipsychotic for the 4 weeks prior to randomization, have stable psychotic symptoms without a hospitalization for the 8 weeks prior to randomization, and were to be smoking an average of >=10 cigarettes per day. Enrolled patients who no longer met entry criteria at randomization were not randomized.
749792|NCT00669877|Recruitment Period: August 15, 2002 to August 28, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
749793|NCT00669864|22 sites in China|Eligible subjects, treated with basal insulin, stopped their oral anti-diabetic drug treatment and started a run-in period of forced metformin titration. Subjects on current metformin therapy could go through a modified titration. Doses were up-titrated weekly until either the max tolerated dose of at least 1500mg/day or a max dose of 2000mg/day.
749794|NCT00669682|9 patients enrolled from device clinic between 8/14/08 and 2/11/11|
749795|NCT00669669||
749796|NCT00669617||
749797|NCT00669578|This study opened June 2008 and accrued 12 Phase I participants and 65 Phase II participants before being closed in January 2010.|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts. Dose Limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. However, efficacy was not improved at higher doses and the most effective dose level was deemed 0.5 mg/day.
749798|NCT00669552||
749799|NCT00669539||
749800|NCT00669461||
749801|NCT00669396||
749802|NCT00669383|This randomized trial was conducted at Oregon Health and Science University in Portland, OR and at Sacred Heart Hospital in Pensacola, FL. Subjects were recruited from June 2001 to May 2007.|Women who showed no further signs of preterm delivery after consent were not randomized.
749803|NCT00669331||Prior to randomisation, subjects underwent a Mannitol Tolerance Test (MTT) - only those who passed the MTT were eligible to be randomised. 581 patients in total underwent the MTT
749809|NCT00669110|Eligible participants transitioned from preceding Core study NCT00619619 (3151A6-2000 [B2061012]) on Day 56 to this Extension study NCT00669110 (3151A6-2001 [B2061013]) to continue treatment on a flexible dose schedule. A total of 8 participants (Children n=2 and Adolescent n=6) discontinued during Taper/post-study or Follow-up phase of Core study.|Baseline (Day-1) in the Extension study = Week 8 (Day 56) in the Core study. However, Baseline for the Clinical Global Impressions Scale - Improvement (CGI-I) = Inpatient Day 1 through 4 in the Core study and Baseline for the Columbia Suicide-Severity Rating Scale (C-SSRS) = Day-1 in the Core study.
749810|NCT00669071|Dates of recruitment period: First subject was enrolled on January 8, 2008 and the last subject was enrolled on August 6, 2008.|"The specified wash-out period up to baseline was:
~2 weeks since the use of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)
~14 days for melasma treatments at the time of study entry or under current treatment
~at least 6 months since prior facial IPL, resurfacing, deep or chemical peels from the date of study entry"
749811|NCT00669032|Recruiting started in October 2003 and the last follow-up was performed on July 2009. This study enrolled patients from the Rheumatology Departments belonging to 19 centres located in Spain.|A total of 446 patients were screened, of whom 140 (31,4%) were screening failures. At the screening visit the patients were assessed by the blinded physician for fulfilment of the selection criteria, demographic characteristics and medical history. Knee radiographs were also obtained.
749812|NCT00669019|Patients were enrolled at five sites in the United States between August 2008 and September 2009.|
749813|NCT00668902||
749814|NCT00668863||
749815|NCT00668811||
749816|NCT00668785||
749817|NCT00668746||
749818|NCT00668733|This was a Phase 3b longitudinal and observational study.|Subjects previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, or GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
749819|NCT00668564||
749820|NCT00668525|Recruitment period was from 4/30/08 through 12/19/08 with last patient last visit on 2/24/09 at 45 centers in the US.|A one-week single-blind placebo period was completed prior to randomization. Patients were then randomized in a 3:3:2 ratio to either escitalopram low dose, escitalopram high dose or placebo.
749821|NCT00668434||
749822|NCT00668395|Healthy subjects from self -referrals, campus fliers, Indiana University's Clinical Trials Webpage, community bulletin boards and newspaper were enrolled. All subjects were studied at the Indiana Clinical Research Center. Recruitment was completed within 3 years (8/20/07 to 4/15/10).|The study was initially designed to enroll subjects with prespecified CYP2B6 genotype (*1/*1, *1/*6, and *6/*6; n=20 each), but it was later modified in which subjects were enrolled without pregenotype information and genotype was performed post-hoc.
749823|NCT00668382|Patients recruited from medical and surgical oncology clinics with currently untreatable tumors from march 2007 through June 2011|No assignment to separate arms, Patients had to be off any active treatment for their advanced tumors for at least 2 weeks before entry onto study and a month after. Two subjects withdrew after screening and consent because of stroke (1) and insurance refusal(1). Two patients dropped out in the first month due to treatment needs.
749824|NCT00668317|Patients recruited at the cough clinic at castleHill Hospital|Patients had to have a positive methacholine challenge, and reflux associated chronic cough
749825|NCT00668265|The study was initiated in 2007 adn terminated in 2010 due to PI's departure. All recrutiement took place at Su Casa residential treatment facility in New York City. All recruitment was done by the PI.|The subjects were individuals with opiate addiction on agonist therapy. After recruitement subjects underwent methadone taper as inpatients. Most subjects left the study because they signed out of the Su Casa Program and did not complete their methadone taper.
749826|NCT00668200||
749827|NCT00668148||Presented are the reasons the participants discontinued from study treatment.
749828|NCT00667992|144 were enrolled, 45 were excluded: 11 for eligibility not fulfilled, 8 with condition under investigation worsened, 8 for voluntary withdrawal, 17 with reasons not specified, and 1 lost to follow-up and 99 were randomised.|
749829|NCT00667875|Subjects were recruited from the community in response to advertising in local papers, and radio|Subjects were to remain abstinent for 4 days prior to starting treatment with the randomly assigned study drug.
749830|NCT00667849||
749831|NCT00667810|The study was terminated on 06 August 2012 due to lack of clinical efficacy observed in completed studies ELN115727-301 (ApoE4 non-carriers) and ELN115727-302. A total of 329 participants had completed the study up to and including Week 78 before the decision was taken to terminate the study.|The study originally included bapineuzumab 2.0 mg/kg dose level, which was discontinued on 02 April 2009 based on input from independent safety monitoring committee. It was estimated at the time that about 10 participants received 2.0mg/kg. These participants are not included in the efficacy analyses.
749832|NCT00667745||
749833|NCT00667732|Recruitment: March 2007 - February 2009 Participant source: medical clinics, local communities|There were 8 weeks of open-label exenatide use before enrollment into the randomized portion of the study to ensure patients ability to tolerate medication before adding insulin to the medication regimen.
749834|NCT00667693||
749835|NCT00667615||
749836|NCT00667602||All participants enrolled were included in the trial.
749837|NCT00667589||
749838|NCT00667576||
749839|NCT00667563||
749840|NCT00667511||
749841|NCT00667459||
749842|NCT00667446|Participants who successfully completed and showed maintenance of luteinizing hormone suppression through the 6-month treatment period of the lead-in study L-CP07-167 (NCT00635817) received the same treatment in this study that they were previously assigned in the lead-in study.|At the end of the Treatment Period, participants who completed the study or prematurely discontinued from the study could enter the Safety Follow-Up Period.
749843|NCT00667420|Between June 2008 and July 2010, 17 patients with adenocarcinoma of the stomach were accrued to the protocol at the MGH and Dana Farber Cancer Institute.|
749844|NCT00667394||
750498|NCT00630994|Four (4) patient was recruited from March 2008 to May 2009 at Mayo Clinic. This trial was permanently closed in September 2009 due to slow accrual.|
749845|NCT00667381|Between April 2008 and February 2009, 1014 patients presenting for elective or urgent (but not emergent) cardiac or peripheral catheterization were enrolled.|10 patients (6 control, 4 US) were excluded after randomization but before procedure for no longer meeting the inclusion criteria, including cancellation of the procedure, lack of a dual-trained operator, or change in access site. Baseline and procedural data were not recorded in this group, and these were not included in any analysis.
749846|NCT00667368|The target enrollment was 1370 and 1370 participants were randomized, but 5 participants were later found to be enrolled twice. The second enrollment of these participants were removed; therefore, the total enrolled was 1365.|
749847|NCT00667355||
749848|NCT00667342|Forty-three participants were enrolled between June 2008 and May 2012: 34 at St. Jude Children's Research Hospital, 6 at Rady Children's Hospital San Diego, 2 at Johns Hopkins University Hospital, and 1 at M.D. Anderson in Houston|All participants had newly diagnosed high-grade, biopsy-proven osteosarcoma, or malignant fibrous histiocytoma (MFH) of bone
749849|NCT00667277|Subjects were enrolled in this study between May 2008 and March 2009|
749850|NCT00667251||
749851|NCT00667225|Patients were recruited from the UNC Dermatology clinics, through practitioners in the surrounding community, and through mass email to the University system (University of Chapel Hill).|Participants were excluded if they did not meet inclusion criteria, if they did not have a true diagnosis of molluscum contagiosum, if they were immunosuppressed, or if they had previously been treated with cantharidin.
749852|NCT00667186|This study enrolled patients from January 2008 through December 2010. This study was conducted in the emergency department of a Midwestern, urban, teaching hospital with an annual ED census of over 90,000 patient encounters.|Patients were ineligible if age was <18 or >64, they were known to be positive, or they had been previously approached for HIV testing in the ED that day. Post-exposure testing (e.g. occupational, assault, etc.) was not provided and persons for whom such testing was indicated were excluded.
749853|NCT00667095|A total of 25 subjects were recruited from 10/21/2008 to 8/19/2010. Three of these were determined to be screen failures before randomization, and another one was withdrawn prior to randomization. Twenty one subjects were randomized: 11 to Botox/DMSO, and 10 to DMSO only.|
749854|NCT00667017|Consent Withdrawn After Treatment Started. Pt withdrew from treatment due to side effects|
749855|NCT00667004||
749856|NCT00666978||
749857|NCT00666965||
749858|NCT00666926||Expansion cohort (E1 or E2): participants were to be those enrolled at maximum tolerated dose level. E1: to have advanced disease likely to possess functional aberrations of pathways for tumorigenesis (represent focal adhesion kinase [FAK] expression). E2: to have disease characteristics associated with FAK expression and agree to repeat biopsies.
749859|NCT00666848||Subjects received a placebo pill for 5 days prior then arm 1,2,or3 and crossed over to sitagliptin 100mg/day for 5 days prior to arm 1,2,or3. This is a parallel cross over study. 43 subjects were consented. 15 did not meet inclusion criteria. 3 withdrew before randomization.
749860|NCT00666835|A total of 568 patients were screened. 479 were eligible for inclusion and were randomized. 478 patients were started on treatment with either epoetin alfa HX575 Hexal AG or ERYPO®, Janssen-Cilag. As the randomization followed a 2:1 scheme, 314 patients received HX575 Hexal AG and 164 patients received ERYPO®.|The first part of the study was designed as a double-blind, randomized, multicenter, parallel-group equivalence study and consisted of two phases: Phase I (dose adjustment and maintenance of Hb level; until week 24) followed by Phase II (evaluation period: four week evaluation period to determine the primary efficacy endpoint; weeks 25 until 28).
749861|NCT00666757|The United States study started in May 2008 and completed in March 2009. A total of 72 sites participated (65 Psychiatric, 5 Family Practice, and 2 Internal Medicine specialties).|
749862|NCT00666718||
749863|NCT00666705|One site in the United States|Subjects were to be healthy male or female subjects between the ages of 18 and 55 years, inclusive. Subjects were required to meet all eligibility criteria prior to randomization into the study.
749864|NCT00666679|"Patients were recruited from 25 centers worldwide. Patient screening began 05-May-2008 and the first patient was randomized on 29-May-2008.
~The last patient's last visit was completed on 16-Feb-2009."|"278 participants were screened; 144 were excluded.
~Randomized patients met the following criteria: FEV1 (Forced expiratory volume in one second) 50-80% predicted while withholding short-acting beta agonist (SABA) and reversibility of airway obstruction >12% following SABA documented on at least two of the following visits: Visits 1, 2, and 3."
749865|NCT00666666|Patients were recruited from April 2008 through July 2010, from four academic medical centers.|There are no pre-assignment requirements.
749866|NCT00666588||
749867|NCT00666562|Participants were recruited during a 4 year period by staff at 5 participating institutions (both University hospitals and community clinics).|
749868|NCT00666536||369 and 359 are the total randomized patients by treatment groups respectively. In the baseline measures tables 366 and 357 are the total patients for the ITT population by treatment group.
749869|NCT00666458||
749870|NCT00666406|9 unique participants enrolled and treated at a single study site in Germany|Participants required a factor VIII (FVIII) washout period ≥48 hours before receiving any pharmacokinetic (PK) infusions and could not be actively bleeding at the time of the infusion.
749871|NCT00666328|Patients considered for inclusion in this study were recruited from June 2008 through April 2010 primarily from hospital emergency departments and Neurology Intensive Care Units, having presented with acute hypertension and intracerebral hemorrhage (ICH). Enrollment targeted a subset of ~10 patients requiring intracranial pressure (ICP) monitoring.|Participants were required to have a systolic blood pressure (SBP) greater than 160 mm Hg both prior to enrollment and immediately prior to study drug initiation. Participants with SBP </=160 mm Hg immediately prior to study drug did not receive clevidipine and were treated per standard of care.
749872|NCT00666276|This was an open label, prospective, multi-center non-interventional cohort study.|
749873|NCT00666263|Recruitment was conducted in the U.S., Canada, and Europe at 17 study sites. The first participant was enrolled in August 2008.|Fifty unique potential participants were enrolled at clinical study sites in North America and Europe. Six were screen failures. Therefore, 44 participants were randomized.
750638|NCT00623233||
749874|NCT00666224|A clinically isolated syndrome (CIS) is a first neurological episode, lasting at least 24 hours, caused by inflammation/demyelination in one or more sites in the central nervous system (CNS.) Subjects were enrolled within 90 days of the event and randomized up to 32 days following screening.|Six-hundred and nineteen (619) subjects were screened for this study; 138 subjects were screening failures, including one subject, randomized in error. This subject, who had a relapse between screening visit and baseline, never received any treatment, and is considered a screening failure.
749875|NCT00666211|This study opened to accrual May 2005 through May 2010. Although 99 patients were consented one was determined ineligible, thus only 98 went on study.|
749876|NCT00666198||
749877|NCT00666029||
749878|NCT00665925|The first participant received the first dose of study drug on 19 May 2008; the last participant completed the study on 01 June 2009. Participants were recruited from centers in the United States, Europe and Latin America.|Male/female participants who had active rheumatoid arthritis (RA) for a minimum of 6 months, and receiving a weekly methotrexate (MTX) dose for a minimum of 3 months were randomly assigned to receive R788 150 mg once daily, 100 mg twice daily, placebo once daily or placebo twice daily. It was planned to randomize approximately 420 participants.
749879|NCT00665847|In total, 41 investigators in 13 countries enrolled patients in study TMC125-C213. A total of 103 patients were documented as being enrolled in the study, however 2 patients were randomized in error. Therefore, 101 patients were enrolled and treated with etravirine (ETR) also known as TMC125 and included in the intent-to-treat (ITT) population.|
749880|NCT00665704||
749881|NCT00665652||
749882|NCT00665626|The first participant received the first dose of study drug on 28 May 2008; the last participant completed the study on 09 June 2009. Participants were recruited from centers in the United States, Europe and Latin America.|Male/female participants who had active rheumatoid arthritis (RA) for a minimum of 12 months and who had failed prior biologic therapy were randomly assigned to receive R788 100 mg twice daily or placebo. It was planned to randomize approximately 195 participants.
749883|NCT00665561||Study was conducted at multiple sites between 31 March 2008 and 14 February 2019.
749884|NCT00665470||All patients were enrolled into cohort I because all patients were able to receive high dose IL-2.
749885|NCT00665457||
749886|NCT00665444||
749887|NCT00665431||
749888|NCT00665366||Of 493 participants enrolled, 370 were randomized, and 369 received treatment with double-blind study medication.
749889|NCT00665353|Subjects were enrolled at 8 ACTG sites. The dates of first and last study enrollments were March 31, 2009 and May 26, 2010, respectively.|A5239 was a single-arm study which enrolled prior nonresponders to peginterferon (PEG-IFN) and ribavirin (RBV)> therapy with documented insulin resistance. 31 potential subjects failed to meet all inclusion/exclusion criteria. 22 of these potential subjects did not meet the HOMA-IR criterion (> 2.5 within 42 days prior to study entry).
749890|NCT00665132||
749891|NCT00665002|Participants were recruited at Moffitt Cancer Center from 06/30/2008 to 12/13/2012.|
749892|NCT00664859|Of the 192 subjects who completed the double-blind (DB) period, 140 rolled over into the extension study and received at least one dose of open-label (OL) study drug to form the safety population.|
749893|NCT00664755||
749894|NCT00664742||614 participants enrolled. 607 participants treated.
749895|NCT00664560||
749896|NCT00664534||
749897|NCT00664521||
749898|NCT00664430||After Screening, participants entered an 8-week controlled calcitriol period. Participants whose parathyroid hormone (PTH) levels decreased after 8 weeks (i.e., participants who were not resistant to calcitriol) were discontinued from the study.
749899|NCT00664326|Male or female untreated participants, who were at least 18 years of age, with metastatic and/or unresectable, measurable predominantly clear cell renal cell cancer (RCC) histologically or cytologically documented could participate in this study at 18 centers in 6 countries.|Of 64 enrolled participants, 49 received study medication, and 15 were screen failures due to protocol violation (12 participants), withdrawal of consent (1 participant), adverse event (2 participants).
749900|NCT00664209||Of 64 enrolled, 13 positive for H. Pylori were screened for motor fluctuations (wearing off of the benefits of levodopa).
749901|NCT00664105|Recruitment Period = 2/18/2004 through 1/23/2007|A total of 66 people consented to take part in this study and of those, 1 was determined to be ineligible and 2 withdrew from the study prior to beginning protocol therapy.
749902|NCT00664066|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|The decision to enrol a subject was not to be made until after the decision on erythropoietin therapy had been made by the physician and drug had been prescribed. Physicians were to manage subjects according to their local practices and protocols.
749903|NCT00663962|REB approval from our institution was received to enroll 15 patients, who had given written informed consent, into this pilot study. All elective ASA I - III patients aged 18 - 75 scheduled for open thoracotomy or video assisted thoracotomy (VAT) were screened for inclusion in this study.|Thirty-nine patients were screened between April 23 and November 27, 2008. Fifteen patients were eligible for inclusion.
749904|NCT00663923|Both eyes of Fifty patients with medium-high compound myopic astigmatism(1.5- 5 D) were enrolled in a prospective randomized study between sep 2007 and sep 2008 at Nikookari eye hospital and Mehr eye center|All enrolled patients having inclusion criteria accepted both available techniques for correction of astigmatism.
749905|NCT00663858||
749906|NCT00663819||
749907|NCT00663793|Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle WA, between April 2008-March 2009.|19 participants recruited; 19 screened, 2 excluded.
749908|NCT00663702|Participants were enrolled at 3 locations and 32 sites worldwide: United States (20 sites), Canada (6 sites), and Mexico (6 sites).|A total of 126 participants were enrolled, and 3 discontinued prior to study start due to failure to continue to meet study eligibility criteria.
749909|NCT00663403||
749910|NCT00663260|Of 631 participants enrolled, 276 completed a qualification period. Of these 276 participants, 252 were randomized and received treatment. Of these 252 participants, 204 completed double-blind treatment period.|
749912|NCT00663208|167 enrolled; 30 entered treatment Period. Reasons for not entering: 1 lost to follow-up, 4 withdrew consent, 5 administrative reasons, 6 other, 121 did not meet study criteria.|A total of 30 participants received study treatment.
749913|NCT00663169||
749914|NCT00663117|This prospective, double blind, randomized placebo-controlled trial, undertaken between September 2006 and September 2009 at the Pennsylvania State University College of Medicine.|
749915|NCT00663052||
749916|NCT00663039||
749917|NCT00663026||
749918|NCT00662909||After screening, 2149 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 1329 eligible patients were randomly assigned to receive mirabegron 50 mg, mirabegron 100 mg or a matching placebo for 12 weeks.
749919|NCT00662857|This was a single site with first subject screened 24 Apr 2008|Subjects assigned at Visit 2 to either: 2 15 U cartridges (TI Inhalation Powder A) or 1 30 U cartridge (TI Inhalation Powder B). At Visit 3 each subject was crossed over to the other treatment group. At Visit 4 subjects received a single sc injection of 10 IU of insulin lispro to 1 of 3 possible injection sites: arm, leg, or abdomen.
749920|NCT00662831||
749921|NCT00662818||
749922|NCT00662675||The initial (screening) dose of PANCREASE MT was based on the average dose of pancreatic enzyme replacement therapy (PERT) taken for the 3 days immediately before entry into the study in combination with a high-fat diet. This PERT was continued until all screening test results were received and the subject met all inclusion/exclusion criteria.
749923|NCT00662649|Of the 1272 patients randomly assigned to treatment in the Core study (ClinicalTrials.gov ID NCT00289978), 1033 completed the 24-month double-blind treatment phase and were eligible to enter the Extension study. A total of 920 of the 1033 patients entered the Extension study and received treatment.|
749924|NCT00662558||
749925|NCT00662545|participants recruited from medical clinic, between 7/2008 and 6/2009and 20011|Overall sample size was reduced to 10 due to difficulty in recruitment
749926|NCT00662532||
749927|NCT00662389||
749928|NCT00662363|Participants were recruited from the inpatient population of an academic freestanding rehabilitation hospital following admission for impairments related to an orthopedic surgery.The study was approved by the local institutional review board and all subjects provided written informed consent.|72 patients were recruited. There were eight who did not meet inclusion and/or exclusion criteria following consent and screening visit. Reasons for exclusion were: history of Crohn's disease (1 person), history of irritable bowel disease (1 person), diarrhea on baseline visit day (1 person), or no associated bowel symptom (5 persons).
749929|NCT00662311||
749930|NCT00662298||
749931|NCT00662259||
749932|NCT00662207|Only spinal cord injured (SCI) patients using intermittent catheterization or reflex voiding with upper motor neuron injuries participated in this study. Three SCI male patients were enrolled and no adverse events occurred.|
749933|NCT00662155||129 individuals were eligible for Phase 1 (2-week assessment period) of the study. 12 participants were withdrawn for non-compliance, 14 dropped out, 28 did not experience a treatment response during Phase 2, and 1 discontinued due to a minor adverse event. In total, 74 participants advanced to phase 3 of the study.
749934|NCT00662129||
749935|NCT00662038||
749936|NCT00662025||The study consisted of 2 cohorts. Cohort 1 enrolled 6 participants. All adverse events in Cohort 1 were evaluated at the end of Cycle 2, and study continuation to Cohort 2 was determined based on the recommendation from the Independent Safety Monitoring Committee. Cohort 2 consisted of 63 participants, including the 6 participants in Cohort 1.
749937|NCT00662012|Recruitment commenced on 11May2002 with follow-up periods ranging from 12 to 24 months after completion of treatment. Treatment was received at Walter Reed Army Medical Center, Washington, DC, USA.|
749938|NCT00661999|Five-hundred and two (502) participants were recruited between February 2006 and December 2008 at Mayo Clinic Cancer Research Consortium (MCCRC) sites.|Eight patients canceled before the first dose of darbepoetin alfa (DA) (3 DA + Intravenously (IV) Iron, 3 DA + Oral Iron and 2 DA + Placebo); and 4 patients were ineligible (2 DA + Oral Iron, 2 DA + Placebo). These 12 patients were excluded from all analysis.
749939|NCT00661960|Subjects are recruited from the specialty clinic and their friends or family.|no special pre-assignment details
749940|NCT00661895||
749941|NCT00661830|First patient in was on 27MAY2008 Last patient out was on 20JUL2011|Six patients were enrolled but never treated. 97 patients were treated with study drug.
749942|NCT00661778||The data listed in Participant Flow are for discontinuation from treatment, not discontinuation from the study. Data for discontinuation from the study are not available.
749943|NCT00661726|Recruitment began in early 2007 at one site, Toronto General Hospital. When recruitment became too challenging, the study was moved to the Thalassemia Clinical Research Network and opened at 2 more sites in 2008. These included Children's Hospital in Philadelphia and Children's Hospital in Oakland. Recruitment closed in May, 2010 with 6 subjects.|To be eligible, patients had to be >=18 years of age and have beta thalassemia intermedia or beta thalassemia-HbE intermedia, no transfusions for 120 days, no hydroxyurea for 120 days, have RBC folate levels above the lower limit of normal, and steady-state anemia (post pt #2, the protocol was amended to define anemia hemoglobin level of <10g/dl).
749944|NCT00661713|Subjects were enrolled at 10 study centers in Chile.|All enrolled subjects were included in the trial.
749945|NCT00661687|Recruitment began on 12/24/07 and lasted for 1 month. Participants were recruited from 10 Asian Sites.|206 participants were enrolled. 204 participants were eligible and 189 completed the study. Study was a contralateral design with one eye of each patient randomly assigned to the experimental group and fellow eye to the control group.
749946|NCT00661674||
749947|NCT00661661||Participants received study drug (CP-690,550 or placebo) in the precedent study A3921039 (NCT00603512) for 12 weeks, A3921040 (NCT00687193) for 12 weeks, or A3921044 (NCT00847613) for 2 years.
749948|NCT00661622||
750026|NCT00658619||Stage 1 of the study was a patient-masked, dose-escalation, paired-eye comparison and the Investigator was not masked. Stage 2 was a parallel-group, sham-controlled, paired-eye comparison. Investigators were masked as to dose received for patients in the active treatment groups. No patients from Stage 1 were enrolled in Stage 2.
750027|NCT00658606||
749949|NCT00661609|Patients were recruited at 23 study sites in 5 countries: United States (7 centers), United Kingdom (6 centers), Germany (5 centers), Canada (3 centers), and Spain (2 centers) between 29 May 2008 and 11 January 2010. 54 participants were enrolled into the study of which 41 participants received at least one dose of study medication.|Following enrolment there was a screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with AZD4877.
749950|NCT00661583||
749951|NCT00661570|Patients were recruited at the outpatient clinic when they came in for a voice prosthesis replacement.|
749952|NCT00661557||
749953|NCT00661544|Recruitment Period: 03/31/2004 through 08/02/2005. All pariticipants recruited at U.T. M.D. Anderson Cancer Center.|
749954|NCT00661531||
749955|NCT00661505|A total of 132 participants were enrolled in this study conducted from 14 May 2008 to 22 June 2010 at 20 centers in Turkey.|
749956|NCT00661492|Between May 2008 and March 2009, 115 eligible patients were enrolled, 75 in the CMP arm and 40 in the MP arm.|5 patients with Withdrew Consent and 23 patients with Failed Entry.
749957|NCT00661479||Patients were stratified by Best Corrected Visual Acuity (BCVA). Patients assigned to Group A had a BCVA of 20/320. Patients assigned to Group B had a BCVA worse than 20/40 and better than 20/320. Patients in Group A were randomized and treated prior to initiating enrollment in Group B. No patients from Group A participated in Group B.
749958|NCT00661466|Study was terminated due to poor recruitment|
749959|NCT00661453||
749960|NCT00661427||
749961|NCT00661388|A total of 75 participants were enrolled in this study conducted from 12 August 2008 to December 2010 at 9 centers in Turkey.|
749962|NCT00661362||
749963|NCT00661271|96 individuals consented to study participation and 93 were randomized. However, only 72 were able to be contacted for subsequent baseline data collection.|
749964|NCT00661258|A total of 80 patients were recruited at the Dali 2nd People's Hospital, in Dali, Yunnan Province, from June to November 2006 in the 6-month pre-intervention period. A total of 68 patients completed this passive phase and were randomized to intervention vs. control arm.|
749965|NCT00661193||
749966|NCT00661141||Although originally planned to receive Antizol 7.0 mg/kg, participants in Cohort 4 were dosed with study drug (Antizol or placebo) at 1.0 mg/kg,the same level dosed for the Cohort 1 participants. As a result, Cohorts 1 and 4 were combined together in the data summary and statistical analyses.
749967|NCT00661089||
749968|NCT00661037||
749969|NCT00660985||
749970|NCT00660907|The 1st patient was enrolled on 31 Mar 2008. The last patient last visit was on 15 Dec 2009. 1901 patients (pts) were screened and 1217 pts were enrolled with the aim to randomize 816. 2 randomized pts were excluded since they received no medication. Eventually, 814 pts received medication. This study was conducted at 95 centers world-wide.|For participants with a metformin dose of less than 1500 mg/day, a change in metformin dose in the past 8 weeks or on an Oral Anti-Diabetic (OAD), an 8-week metformin-only dose stabilisation period occurred. A 2-week placebo lead in period occurred after the dose stabilisation period or after enrolment if dose stabilisation period was skipped.
749971|NCT00660829|First Observation December 13, 2007 Last Observation February 21, 2008|
749972|NCT00660816||
749973|NCT00660790|Participants were recruited from the outpatient clinic from the University Hospital of Graz.|111 subjects were screened for the study between March 2008 and May 2010. Study inclusion criteria were met by 97 patients who were enrolled in the study.
749974|NCT00660699|The study opened to participants enrollment on 09/14/2002 and closed to participant enrollment on 11/06/2012|
749975|NCT00660660|"The baseline figures shown will be for the modified intention to treat population.
~One patient in each treatment group did not receive study drug; therefore, the safety population has one less patient in each treatment than does the randomized study population."|
749976|NCT00660595|Two recruiting sites between 13 may 2008 and 28 Jan 2009: Aurora Hospital Helsinki and Pitkäniemi Hospital Tampere.|Site 01 pre-screened 19 subjects, two were randomised, 12 did not consent to participate and five were not included due to other reasons.One subject completed the study and the other discontinued from the study on Day 2 (subject escaped from the hospital).Site 03 pre-screened 10 subjects, of which only one completed the study.
749977|NCT00660543||
749978|NCT00660530|Men and women at least 18 years of age, receiving hemodialysis (HD) for at least 3 months, with serum P concentrations > 5.5 mg/dL at the end of the washout period, and on a stable dose of P binder and/or active vitamin D (if previously prescribed) for at least 1 month prior to the study were eligible for study participation.|Patients were excluded if they did not previously respond to P binder therapy, had a known non-compliance with oral medications, severe hyperparathyroidism defined as intact-PTH (i-PTH) > 500 pg/ml, were taking any calcium-, magnesium- or aluminum-containing antacids or used an investigational agent within 30 days of study entry.
749979|NCT00660517||
749980|NCT00660504||
749981|NCT00660400|From 05/2008 to 08/2010, 25 patients with Myelodysplastic Syndrome (MDS) were enrolled to the study at Moffitt Cancer Center.|Four patients did not proceed to allogeneic HCT.
749982|NCT00660387||Studies S187.3.001 (NCT00357994) and S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. All study information and results presented reflect the study data and analyses for the two studies combined.
749983|NCT00660348||
749984|NCT00660309||
749985|NCT00660192||
749986|NCT00660179|A total of 955 patients were screened from 158 centers in 39 countries, and 742 patients from 151 centers in 39 countries were randomized|
749987|NCT00660075|Location: CHUL Medical Centre Date: Fall 2007, Winter 2008, Fall 2008|2-weeks run-in period. 6-weeks treatment with sitagliptin 100mg/d or placebo. 4-weeks washout period. 6-weeks treatment with sitagliptin or placebo.
749988|NCT00660049||
749989|NCT00660023||
749990|NCT00660010||This study included 1 treatment group and subjects were assigned the initial dosage depending on their weight. The minimum starting dose was 7.5 mg every 28 days. Study drug was discontinued either when puberty occurred at 12 years +- 6 months for males and 11 years +- 6 months for females or at the discretion of the investigator.
749991|NCT00659984||
749992|NCT00659945|Prospective, double blinded, randomized, two arm evaluation of 150 subjects at high risk for PONV undergoing a standardized general anesthetic with ondansetron and either aprepitant or a placebo. Recruitment period was from June 2008 through November 2009 in the preoperative holding area prior to surgery.|Men and women between 18 and 65 years, at high risk for PONV, undergoing ambulatory plastic surgery under general anesthesia. Exclusion criteria included patient refusal, given other anti-emetics prior to their procedure, history of allergy or sensitivity to study drugs, pregnancy, chronic opioid use, and surgery under intravenous (iv) sedation.
749993|NCT00659880||
749994|NCT00659828||
749995|NCT00659815|This study was conducted in 23 investigative sites in the United States. First participant was enrolled 3/19/2008, last participant exited the study 5/19/08.|312 Participants were enrolled, 2 participants were ineligible at baseline but were dispensed lens care solution and completed the study. 2 participants were not dispensed lens care solution. 308 eligible subjects started the study, 8 were discontinued during the study. 300 participants completed the study.
749996|NCT00659802|Patients were required to have mild to moderate ulcerative colitis to enter the study. Study was conducted at medical clinics and hospitals in the United States, Ukraine and Romania.|
749997|NCT00659789|The first subject was screened on 29 July 2008 and the first immunization was given on 22 August 2008. The last subject completed the study (to Week 52) on 22 June 2010. The last long-term follow-up visit was 07 June 2011.|137 study participants were enrolled. One participant withdrew prior to randomization.
749998|NCT00659737||
749999|NCT00659724||
750000|NCT00659633||
750001|NCT00659607|A total of 6,901 Case Report Forms were retrieved from 281 study centers. Three thousand and nine hundred thirty two (3,932) patients were eligible for the safety assessment. As requested by KFDA to be in line with the registered indication, 2, 969 patients with mild hypertension and treatment naïve patients were excluded from analysis.|
750002|NCT00659581||In the survey, 21,433 patients were enrolled. The data of 439 patients have not reported after the registration, and 551 patients were not observed after the registration: 38 entry violation, 24 contract violation, 493 no office visit after initial prescription and 9 undefined study medication (the numbers were overlapping).
750003|NCT00659529||
750004|NCT00659490|1 centre (Lifetree Clinical Research, Salt Lake City, Utah, USA) recruited between Feb and May 2008|Screening for eligibility
750005|NCT00659438|From February 4th, 2008 to April 26th, 2010, 8 centers in France.|110 participants screened; 95 participants were randomized to receive either bicalutamide 150 mg + vandetanib 300 mg once daily oral dose or bicalutamide 150 mg + placebo.
750006|NCT00659425||A total of 57 participants were enrolled of which 55 participants received treatment.
750007|NCT00659373||Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.
750008|NCT00659360||
750009|NCT00659334|Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU.|There are seven groups in the study. In Groups 1(adults) and 4(pediatric) subjects receive the Combidex infusion only. In Groups 2(adult) and 5(pediatrics) subjects receive Combidex and undergo neurosurgery. In Groups 3(adult) and 6(pediatric) subjects undergo surgery with tissue exam; and in Group 7(adult only) subjects with MS or stroke.
750010|NCT00659295|Study conducted globally in 26 countries. Some countries participated for only 3 months, while others extended their participation to 6 and 12 months, respectively.|Subjects with type 1 or type 2 diabetes including newly diagnosed subjects who had never received insulin or an insulin analogue at the prescribing physician's discretion.
750011|NCT00659269|Subjects were recruited between July, 2006, and September, 2013, at participating cancer clinics across the state of New Mexico|
750012|NCT00659230||
750013|NCT00659165|Sporadic Newspaper advertisement, Albuquerque Journal, July 2008-July 2010.|Three weeks of treatment with each insulin (glargine, detemir) in random order, double blind assignment. Doses of glargine and detemir were equivalent and were based upon existing long acting insulin doses. Doses were titrated up to achieve target fasting glucose < 150 mg/dl. Both long acting insulins were given once daily before breakfast.
750014|NCT00659061||
750015|NCT00658996|This 4-week study was conducted at 12 sites in Asia. First participant enrolled 4/16/08, last participant visit was 6/20/08|220 participants were enrolled in the study, 4 participants were ineligible at screening visit, 216 Subjects started the first intervention. 211 participants started the second intervention. 209 participants completed the study.
750016|NCT00658879||
750017|NCT00658814||
750018|NCT00658788||
750019|NCT00658775||Out of 1069 participants who were randomized, 1065 participants received study treatment.
750020|NCT00658736||
750021|NCT00658723|A total of 11 clinical centers in the US partipcated in the trial enrolled 141 subjects. The first subject randomized: March 26, 2008 and the last subject completed: April 24, 2009|The efficacy results are based on the intent-to-treat (ITT) set, which is based on 90 randomized subjects from the two randomized arms - Fibrin Pad Randomized and SURGICEL(TM) Randomized. The Fibrin Pad Non-randomized arm was used for the safety analysis set.
750022|NCT00658697|42 patients were enrolled between June 2, 2008 to December 14, 2010 at Dana Farber Cancer Institute and University of Michigan. One patient never started any study treatment, and was excluded from analysis.|
750023|NCT00658684|Subjects were screened at 12 centers in Japan.|After screening, eligible subjects entered a run-in phase during which they completed a 3-day micturition diary for 3 consecutive days in 7 days prior to Baseline visit. At Baseline visit, the diary data and screening laboratory data were checked against the entry criteria to identify subjects eligible for study participation.
750024|NCT00658658|This study was conducted at 7 centers in the United States. Participants were enrolled from 14 March 2008 to 4 March 2015.|Three dose regimens were to be tested in pediatric patients stratified by age group (1 to 11 versus 12 to 17 years). Participants were enrolled sequentially into each dose group, beginning with the 2.5 mg/kg, 12 to 17 year old cohort, based upon demonstration of sufficient safety.
750025|NCT00658632||Out of 1397 participants who were randomized, 1380 participants received study treatment.
750028|NCT00658567||
750029|NCT00658541||
750032|NCT00658411|Adult patients with AML, ALL, MDS scheduled for HSCT with myeloablative conditioning, who in addition were found to have both a serum ferritin ≥ 1000 ng/ml and a liver iron content (LIC) > 5 mg/g dry weight (mg/gdw) based on hepatic T2* measurement, were offered enrollment on the chelation study.|
750033|NCT00658385||
750034|NCT00658359|Participants were recruited and studied between 18 August 2008 and 18 February 2015. Those with 6-month time-weighted concentrations at 2-hours postdose (TWC2) above the median (Amendment 3), negative/unknown Epstein-Barr virus (EBV) at transplant, cytomegalovirus disease or lymphocyte-depleting agents posttransplant (Amendment 4) were discontinued|Participants who had completed 12 months treatment with tofacitinib or cyclosporine (CsA) in previous parent study (A3921030) continued study drugs for an additional 60 months in this extension study.
750035|NCT00658333|Subjects were recruited in the US from March 2008 to March 2009.|Patients were screened for eligibility. If eligible, willing to participate and provided informed consent, patients were randomized in a blinded fashion to either an equimolar dose of enteric-coated mycophenolate acid (MPA) or remained on the current dose of mycophenolate mofetil (MMF).
750036|NCT00658320||Core Study randomization was conducted within 24 hours post reperfusion. Participants who completed the 12 month visit of the Core Study and met inclusion/exclusion criteria were eligible to participate in the Extension Study and continued the same treatment as the Core Study until Month 24.
750037|NCT00658138|61 subjects were recruited from 70 patients with a total of 134 study teeth. Recruitment was from December 2008 to April 2009. Subjects were recruited from patients attending PI's clinic|All enrolled participants took part in the study
750038|NCT00658112||
750039|NCT00658021|This study was conducted in adolescents (aged 10 to 17 years inclusive) with type 2 diabetes who were naïve to antidiabetics, or were receiving metformin, an sulfonylurea (SU) or a combination of metformin and an SU in 7 countries (Brazil, India, South Korea, Mexico, Russia, the United States and South Africa) between 30 May 2008 and 01 April 2020.|The study commenced with a 1-week, single-blind, injectable placebo lead-in period before participants were randomized to 1 of 3 treatment groups: exenatide 5 microgram (mcg) twice daily, exenatide 10 mcg twice daily, or placebo twice daily. A total of 122 participants were randomized in this study.
750040|NCT00657917|Recruitment was conducted at Walter Reed Army Medical Center, Washington, DC. One subject was enrolled.|
750041|NCT00657709|16 sites in Finland, 28 sites in the Czech Republic, 13 sites in Germany, 6 sites in Austria, 7 sites in Italy.|All enrolled subjects were included in the trial.
750042|NCT00657657|Subjects who received primary neonatal Engerix™-B vaccination 20 years ago in the 103860/272 primary study and who had anti-hepatitis B surface antigen (HBs) antibody concentrations < 100 milli-international units per milliliter (mIU/ml) at the previous available long-term time-point (NCT00240539), were invited to participate in the current study.|
750043|NCT00657618|77 total patients, 74 treated, 34 completed treatment, 43 withdrawals|Due to low enrollment protocol was amended to remove efficacy objective and only collect safety data. No data entry or statistical analyses of patient data was conducted.
750044|NCT00657605||
750045|NCT00657553||
750046|NCT00657540|Due to the nature of the treatment emergent condition of interest, no patients were actively recruited. Potential subjects presenting with moderate to severe pain associated with diagnosed latrodectism were evaluated at 16 sites across the United States. The first subject was enrolled on 10/08/09. The last subject completed the study on 10/27/14.|
750047|NCT00657371|Recruitment Period: March 05, 2008 to May 16, 2010 with recruitment completed in medical settings including university medical centers, ambulatory surgery centers, a community medical center and a physician's office.|
750048|NCT00657358||
750049|NCT00657280||
750050|NCT00657267|Study activated at DFCI in May 2008 and was eventually activated at MGH, UPENN, Wake Forest University Baptist Medical Center, Dartmouth-Hitchcock Medical Center, and Tufts NEMC.|
750051|NCT00657150|The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 28 - 35 days. The study period is from first administration of study medication until day 84 - 91.|Whilst 2055 patients were randomised to treatment prior to surgery in this trial, only 2013 started treatment. Therefore, 42 patients were randomised but not treated.
750052|NCT00657046||
750053|NCT00657020||A total of 45 participants were screened, 22 were considered screen failures. Investigators identified brain regions showing significant blood oxygen-level dependent (BOLD) activation associated with attention in each participant using Functional Magnetic Resonance Imaging (fMRI). Hence, participants categorized into high/low attention conditions.
750054|NCT00656968|We surveyed patients who visited the gastroenterological clinic of Kaohsiung Medical University Hospital (KMUH), Kaohsiung Veteran General Hospital (KVGH). A total of 232 H. pylori-infected patients were randomly assigned to sequential (n = 117) or concomitant (n = 115) therapies.|
750055|NCT00656916|Recruitment Period: 03/24/08 through 12/15/10. All participants recruited at UT MD Anderson Cancer Center.|Study terminated due to slow accrual.
750056|NCT00656851|Twenty four participants were enrolled from the AIDS Clinical Trials Unit and Infectious Diseases Clinics at Washington University School of Medicine in St. Louis, Missouri, USA. This was a prospective, two-group, random assignment study.|Exclusion criteria: medications or dietary supplements that affect metabolism (β-blocker, β-agonist, Ca2+ channel blocker, corticosteroid), neuromuscular disorder that affects metabolism or ability to exercise, consumed >3 alcohol drinks/wk, active Hep C or B, recreational-anabolic -appetite stimulant drugs, regular physical exercise.
750057|NCT00656799||
750058|NCT00656669||Please note that one patient discontinued due to an Adverse Event after completing Segment 2 (Paclitaxel/Sunitinib), but before starting Segment 3 adriamycin & cyclophosphamide (AC).
750059|NCT00656656||
750060|NCT00656630|Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, California from 04/17/2008-12/10/2009. Sixty eight subjects were enrolled, and sixty two subjects completed the study.|
750061|NCT00656617|Recruitment Period: All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 106 participants enrolled, three participants completed the study's first run-in induction portion then another 103 participants were enrolled for the second portion of combined drug induction and maintenance. Four of those 103 enrolled participants were not treated.
750064|NCT00656474|Recruitment occurred in March 2008 at a single site, Clinical Testing Center of Beverly Hills, Beverly Hills, California, United States, 90210.|All subjects needed to meet specific inclusion and exclusion criteria as described in the Eligibility section. Eligible subjects were randomly assigned to receive GLYC-101, 1% or placebo.
750065|NCT00656448|Recruitment period: March 27, 2008 to February 18, 2010. All recruitment done at the University of Texas (UT) MD Anderson Center.|Of the 51 participants enrolled for the epoetin alfa (Procrit) study, fifty (50) participants were randomized and one excluded as a screening failure.
750066|NCT00656370|The first subject entered screening on 19 DEC 2007 and the last subject entered screening on 23 JAN 2008. A total of 25 subjects were assessed for eligibility and signed an Informed Consent Form.|Seven subjects were excluded during screening: 6 did not meet inclusion criteria and 1 withdrew consent. An additional 3 subjects were screened as alternates, but were not enrolled. 15 subjects were randomized and completed stage 1.
750067|NCT00656305||Of the 147 subjects enrolled (signed consent), 23 subjects failed additional study requirements and 9 subjects exited after randomization but prior to treatment
750068|NCT00656292||
750069|NCT00656201|All patients starting an IVF cycle will receive a letter from their physician and Dr. Yanushpolsky. We will include a copy of the consent form. This letter will briefly describe the study and will have an opt out paragraph. Patients fulfilling inc/exc criteria will be approached on the day of their oocyte retrieval by a study coordinator.|The participant may not qualify for enrollment if there were no eggs fertilized, or no embryos transfered, or all embryos frozen.
750070|NCT00656175|"61 subjects were screened, 39 enrolled, and 37 completed the Week 24 primary endpoint at 5 sites in North America.
~Of the 37 subjects included in the as-treated analysis, 17 were randomized to immediate-switch (Immediate Group), and 20 to delayed-switch (Delayed Group)."|
750071|NCT00656136||Two-arm, randomised (2:1 ratio), double-blind , placebo-controlled, multi-centre trial. 585 patients were randomised. All patients randomized received at least one dose of study medication.
750072|NCT00656084||
750073|NCT00656058||
750074|NCT00656019||
750075|NCT00655980|687 patients signed consent for enrollment; only 625 were analyzed.|
750076|NCT00655928||
750077|NCT00655889|Patients were recruited between July 17, 2006 to September 11, 2006.|
750078|NCT00655876||
750079|NCT00655863|Participants enrolled at 2 investigative sites in The Netherlands and Sweden from 16 July 2007 to 17 December 2009.|Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of three, once-daily (QD) treatment groups.
750080|NCT00655850|Protocol Open to Accrual: March 2008, Primary Completion Date: September 2015 and Study Completion Date: September 2016. Recruitment location: University of Alabama at Birmingham.|This study is being done to determine the overall progression-free survival (PFS) in patients with advanced or metastatic (Stage IIIB - pleural effusion/IV), non-squamous histology Non-Small Cell Lung Cancer (NSCLC) treated with metronomic chemotherapy plus Avastin.
750081|NCT00655824|Participants who previously participated in Study OFA112657 (NCT00291928) and who fulfilled the eligibility criteria were offered participation in this study (111752; NCT00655824).|A participant was considered to have completed the study when the Investigator decided that the participant had completed the treatment phase and recorded this in the Case Report Form. Completion was not based on having completed a set number of treatment courses.
750082|NCT00655811||
750083|NCT00655746||49 participants were enrolled in the study, and 35 discontinued before being treated (26 no longer met study criteria, 6 withdrew consent, 3 group full/not needed)
750084|NCT00655733||
750085|NCT00655707||The planned dose escalation design did not work due to low participants number. All participants received similar dose of Autologous expanded CD34+ cells .
750086|NCT00655668|Recruiting began March 2008; first participant enrolled 16 June 2008 and last participant enrolled 29 January 2010.|Participants with relapsed or refractory, biopsy-proven, T-cell Non-Hodgkin's Lymphoma. Must have received at least one prior chemotherapy regimen which contained two cytotoxic agents.
750087|NCT00655642|Recruitment started March 2007 and completed October 2008. A covenience sample of all adult patients who presented to the emergency department (ED) with a complaint requiring antiemetic treatment who do not meet the exclusion criteria were considered for enrollment.|Not applicable to this study
750088|NCT00655629|Subjects recruited to 35 investigational centers in the USA (20), Canada (4), Mexico (5), and Australia (6). First patient first visit on 28 Apr 2008, last patient last visit on 13 Feb 2009.|473 subjects screened (<65 years: n=230; >=65 years: n=243), 339 randomized (Vardenafil 10 mg ODT=172, placebo=167). The main efficacy analysis set was the ITT (Intent to Treat) population (randomized treated sub. with baseline and post-baseline in any of the efficacy variables and safety assessment); Vardenafil 10 mg ODT=169, placebo=162
750089|NCT00655564|Fifteen subjects with moderate to severe chronic plaque type psoriasis were recruited from the Wake Forest University Health Sciences Dermatology Clinic|
750090|NCT00655551||
750091|NCT00655538||
750092|NCT00655486|The study started in April 2008 with enrollment occuring in the United States only. The study completed June 2010|
750093|NCT00655473||
750094|NCT00655356|Patients were recruited between 1 November 2006 to 27 January 2007|Patients were enrolled and biopsied for manufacture of study product. All randomized patients were included in the Intent to Treat (ITT) population.
750095|NCT00655083|The recruitment period extended from March 2008 to May 2009 at three Hospital Clinics|Twenty out of the 21 enrolled infants were treated with study medication (1 infant did not attend the clinic after screening). NOTE: although the goal was to enroll 24 subjects, slow subject enrollment and expired drug restricted enrollment to 20 subjects
750096|NCT00655057||The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.
750097|NCT00654992||
750193|NCT00647400|Japanese participants with chronic plaque psoriasis who completed the blinded, placebo-controlled Study M04-688 (NCT00338754; 24-week duration) enrolled in the extension study, M04-702, an open-label study until adalimumab received approval for treatment of psoriasis in Japan.|
750194|NCT00647348||
750098|NCT00654953|143 cocaine-using volunteers gave informed consent between 12/15/2005 and 4/8/2009. Consenting occurred at either the UAMS substance abuse treatment clinic, treatment research unit or center for addiction research at the UAMS Psychiatric Research Institute. Of these, 105 eligible participants were enrolled into the study proper.|Of the 143 screened, 42 failed randomization/screening procedures and so were not randomized to receive study medication or placebo.
750099|NCT00654940|Subjects participated in the study between 05 May 2008 and 10 February 2009.|Subjects meeting entry criteria entered into a 1-week screening period to monitor daily pain scores and activity levels. If pain severity met inclusion criteria subjects could enter the double-blind part of the study and were randomized to 1 of 2 treatment sequence crossovers (pregabalin/placebo or placebo/pregabalin).
750100|NCT00654927||
750101|NCT00654901|Participants were enrolled from 25 March 2008 to 28 November 2008 at 5 clinical centers in Mexico.|A total of 881 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
750102|NCT00654875||
750103|NCT00654836|Participants with metastatic breast cancer were recruited from medical clinics between October 15, 2007 and February 15, 2012|No enrolled participant was excluded from therapy
750104|NCT00654784||
750105|NCT00654745|Subjects were recruited at 32 sites in the USA from May 12, 2008 to Jan 2, 2009 and 207 enrolled into the active treatment period. The study population consisted of subjects with controlled type 2 diabetes, not requiring insulin therapy, whose hypertension was newly diagnosed or uncontrolled on antihypertensive monotherapy or combination therapy.|Subjects began washout of anti-hypertensive medications during screening then entered placebo run-in lasting 2-3 weeks. Subjects must meet seated blood pressure (BP) criteria at 2 consecutive qualifying visits during the run-in period and satisfy mean daytime ambulatory BP criteria at baseline, one day prior to the first dose of active study drug.
750106|NCT00654732|Frontline advance stage hodgkin lymphoma|
750107|NCT00654654|Patients were recruited between 22 March 2007 and 8 August 2007|
750108|NCT00654641||
750109|NCT00654628|"Patients were recruited between August 2007 and July 2009.
~In one site, 60 patients among the total 152 study population entered into the 6-week extension period after completing the base period for longer follow-up as per IRB requirement in that site."|
750110|NCT00654615||
750111|NCT00654511||
750112|NCT00654498||
750113|NCT00654420||20 participants were enrolled in Phase I part (dose escalation) and 75 participants were enrolled in Phase II part of study (95 total enrolled).
750114|NCT00654381|Total 6 groups (including sub-groups in placebo and voglibose groups)|"Placebo group has 2 sub-groups, placebo-linagliptin 5mg (from 2nd stage) and placebo-linagliptin 10mg (from 2nd stage).
~Both Linagliptin 5 mg and 10 mg groups don't have sub-group. Voglibose group has 2 sub-groups, voglibose-linagliptin 5mg (from 3rd stage) and voglibose-linagliptin 10mg (from 3rd stage)."
750115|NCT00654368|First patient was enrolled 28 June 2008 and last patient was enrolled 07 November 2010.|A total of 258 participants were enrolled, of whom 205 were randomized after 6 months and 53 were not randomized.
750116|NCT00654355|Subjects were recruited from the Dermatology Studies Center and IRB approved advertising.|
750117|NCT00654329||
750118|NCT00654238||
750119|NCT00654186||
750120|NCT00654147|Patients were randomly assigned to receive one of two regimens Raltegravir (Isentress, Merck & Company) 400 mg twice daily with either Lopinavir/ritonavir (Kaletra, Abbott Laboratories) 200 mg/100 mg twice daily or with emtricitabine/tenofovir (Truvada, Gilead Sciences) 200 mg/100 mg twice daily.|Participants with acute or recent HIV-1 infection, major resistance-associated mutation on any genotype performed at any time prior to study entry, serious illness requiring systemic treatment and/or hospitalization within 7 days of study entry, HBsAg positivity, acute hepatitis of any etiology, clinically significant liver disease were excluded
750121|NCT00654095||"Participants did not Complete the Study:
~level below what was specified in inclusion criterion
~level >500 mg/dL at start of treatment
~level >2x upper limit of normal at start of treatment
~level >=3x upper limit of normal after start of treatment
~Adverse reactions did not improve or resolve after dose reduction of atorvastatin"
750122|NCT00654069|405 post-bunionectomy patients|Subjects dose immediately post-surgery when pain intensity was equal to or greater than moderate. Dosed and followed for 48 hours.
750123|NCT00654030||
750124|NCT00654004|Subjects with a long-chain fatty acid oxidation disorder were recruited through announcements on disease specific websites, and referrals from metabolic physicians. Controls were recruited through the OHSU website and word of mouth.|After a subject had completed the protocol, potential control subjects were screened for age, gender and BMI that would allow for a 1 to 1 matching study design.
750125|NCT00653991||"Allocation 1284 SOLVE-IT (Met exclusion: 573 incomplete baseline; 257 didn't play game; 10 technical glitch)
~Allocation 736 Control (Met exclusion: 202 didn't complete baseline; 43 had technical glitch)."
750126|NCT00653939||
750127|NCT00653861||Other aesthetic procedures and products were not allowed 1 month prior to study entry or any time during the study.
750128|NCT00653523||
750129|NCT00653432||
750130|NCT00653328|Recruitment period = 5/28/2003 through 9/15/2006|A total of 16 people signed consent to take part in this study; of those, one withdrew consent before beginning treatment.
750131|NCT00653263|A total of 13 participants were recruited for enrollment in study entry.|A total of 5 participants did not meet study criteria and did not enter the study proper, leaving a total of 8 eligible subjects.
750132|NCT00653224|A total of 580 patients has been recruited and randomized. Baseline Characteristics describe all randomized subjects. Out of the 580 randomized subjects (ITT population), 578 subjects have been treated at least once (Safety population).|
750133|NCT00653159|This study was conducted within the Section of Family Planning in the Department of Obstetrics and Gynecology at The University of Chicago and within the Department of Family Medicine at the University of Illinois-Chicago. From December 2007 through June 2008, 37 adolescent females were approached regarding the study.|All of the 23 enrolled subjects were ultimately randomized to the treatment arms (12 to LNG-IUS and 11 to CuT380A).
750134|NCT00653133||
750135|NCT00653068||
750937|NCT00609869|Participants were recruited at Moffitt Cancer Center from October 31, 2007 to March, 22, 2012.|
750136|NCT00652951|The study included a Primary (PRI) Phase, up to Month 3, followed by a Booster (BST) Phase, up to Month 9.|At screening the following was performed: informed consent was obtained and signed from subjects' parents/guardians, check for inclusion/exclusion criteria and contraindications/precautions was performed as regards to vaccination, and medical history of subjects was collected. Subjects' pre-vaccination body temperature was evaluated.
750137|NCT00652938||While the total numbers of subjects enrolled in the study was 744, the total number of subjects that entered the study was 741. The remaining 3 subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.
750138|NCT00652899||Two patients did not receive all of study treatment per protocol.
750139|NCT00652834|Kidney Transplant Clinic|
750140|NCT00652743||One enrolled subject was not administered a booster vaccination and hence not considered to have started the study.
750141|NCT00652626||
750142|NCT00652366||
750143|NCT00652340|The study opened to accural in April 2008. Enrollment closed in May 2010. One hundred seventy six patients were enrolled with 120 patients randomized. Patients were recruited from clinical oncology practices.|Enrolled patients underwent a 5-day open label treatment with apricoxib to determine the maximum suppression of PGEM from a baseline measurment. PGEM was used as a biomarker of COX-2 activity in the tumor. Patients with at least a 50% decrease on day 5 from their baseline measurment were eligible to be randomized.
750144|NCT00652327||A total of 202 potential participants signed informed consent during a screening visit. Of these, 119 did not meet protocol eligibility requirements. The remainder, 83, received randomized treatment assignment.
750145|NCT00652314||
750146|NCT00652145|We screened 150 patients and enrolled 119 patients with UC in remission on the basis of SCCAI score. 58 patients had baseline fecal calprotectin(FC) <50 µg/g. These patients were followed in an observational arm. 61 had FC >= 50 µg/g,whose current mesalamine dose <3g/day. See preassignment details.|Among 61 pts with FC >=50 µg/g at week 0, 26 were taking non-MMX mesalamine at baseline and switched to MMX mesalamine 2.4g/day. Of these, by week 6, 2 had a repeat FC <50 µg/g, 3 had a flare of UC and 4 were noncompliant with study protocol or no longer interested in participating. The remaining 52 patients were included in the randomized trial.
750147|NCT00652093|"08 December 2007 (initial IRB approval) to 26 August 2011* (final study results) First patient enrolled: 12 June 2008. Last patient completed: 12 October 2010
~*Study terminated on 29 November 2010 due to US Food and Drug Administration (FDA) removing active control (Darvocet) from the U.S. market."|Forty-three subjects signed the Research Subject Review Board (local IRB) approved consent form. Nineteen subjects failed screening and did not meet inclusion criteria. Twenty-four subjects met radiographic and treadmill criteria for neurogenic claudication and were randomized. Of these, 21 subjects completed all phases of the study
750148|NCT00652080||Subjects were required to have at least one histologically-confirmed SCCIS lesion that was suitable for excision, ie, to have a lesion with a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm.
750149|NCT00652028||
750150|NCT00651937|Recruitment Period: March 13, 2008 to June 5, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.|
750151|NCT00651924|Recruited Dec. 2008-May 2012 for all phases. Participants were recruited from a Comprehensive Pain Clinic and through provider referral.|
750152|NCT00651820||
750153|NCT00651794|All incoming interns for pediatrics, combined pediatrics and internal medicine, family medicine, emergency medicine, and obstetrics and gynecology who began training in June 2007 or June 2008 and had not previously completed NRP certification were eligible for participation in the study.|100 interns were consented, and 98 completed the initial megacode (that is, the initial simulation with a mannequin that was observed and scored). Baseline characteristics are reported for the 98 who completed the initial megacode.
750154|NCT00651755|Recruitment Period: March 14, 2008 to May 3, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the 23 participants who enrolled, three (3) withdrew prior to group assignment and were excluded from the trial.
750155|NCT00651664|Participants took part in the study at 2 investigative sites in Spain from 22 October 2007 to 05 April 2011.|Participants with a diagnosis of advanced malignancies were enrolled in a dose escalation study, alisertib 5, 80 150 mg once daily (QD) for 7 days; 50, 60, 75, 100 mg twice daily for 7 days; 50 mg QD for 14 days; 50, 70 mg QD for 21 days.
750156|NCT00651625|dates from 2004 to August 2010, recruited from medical clinic|patients recruited immediately at point of contact
750157|NCT00651573||
750158|NCT00651482||
750159|NCT00651313|Clinics and private practice offices; 8/31/07-6/13/08. Maximum patient participation was approx 4 months, including 45 day screening period, a treatment period of approx 8 weeks duration (during which subjects received study drug on a total of 8 days), and a post treatment visit occurring 2 - 3 weeks after Treatment Cycle 2,Visit 5.|Crossover study; Subjects who met study entry criteria after completing screening procedures at Screening Visit returned to study center at least 7 days prior to their expected onset of menses to complete Randomization/Treatment procedures. Abnormal lab values, ECGs or use of prohibited medications were among reasons subjects were excluded.
750160|NCT00651261|Between May 2008 and October 2001, 3,277 participants were pre-registered. Of those, 900 participants had a documented FLT3 mutation. 717 participants were enrolled onto this study.|
750161|NCT00651183||
750162|NCT00651157|Twenty three participants were enrolled onto this study between August 2008 and January 2010.|One participant died prior to receiving any treatment and is not included in this study summary. One participant was found to be ineligible and was not used in the analysis of any endpoint, but was used for reporting toxicity. Therefore, 21 participants were used for the primary analysis and 22 participants are used to report toxicity.
750163|NCT00651118||
750164|NCT00651040|Trial has reached 62% of planned recruitment (31 patients randomized).|
750165|NCT00650936||
750166|NCT00650858|Recruitment began for protocol stage 1 in August 2005 and ended for protocol stage 2 on February 6, 2008. Subjects were screened by clinical stroke service personnel in the Emergency Department or by direct transfer from an outside hospital.|
750262|NCT00642707|Recruitment started March 2008 and ended November 2008|There was a screening period of up to 12 weeks. Subjects had to be infected with CCR5-tropic human immunodeficiency virus type 1 (HIV-1)or they were excluded from the study.
750167|NCT00650845|This study did not use randomization. Eligible patients who provided written consent were enrolled chronologically in each investigational center. A total of 142 patients were screened between 29 January 2008 and 05 May 2011, 135 of whom were included in 15 European centers, eight centers in France, three in Belgium, two in Spain and two in Italy.|10 patients were screened but did not undergo the planned procedure: 7 were screen failures and 3 were included but dropped out prior to undergoing the planned procedure. Hence the total number of patients who were assigned to both groups is 132.
750168|NCT00650806|This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) in nondiabetic, overweight, and obese patients. The study was conducted between 31 March 2008 and 18 September 2008 and recruited patients from 38 study centers located in the United States and Puerto Rico.|A total of 376 patients were randomly allocated to the 4 treatment arms in the study and comprised the intent-to-treat analysis set which was used for the efficacy analyses. All 376 patients received at least 1 dose of study drug and were included in the safety analysis set.
750169|NCT00650767|"The ARRAY-162-201 study began recruitment on 04-April-2008 (First Patient First Visit) and concluded on 07-July-2009 (Last Patient Last Visit).
~This study was conducted at 36 sites in the United States, Europe and South America."|Participant Flow and Baseline Demographics represent the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.
750170|NCT00650585|Schools with grades 6-8 who did not currently use an evidence-based substance use prevention program in those grades, and committed themselves to including all their sixth grade students were recruited. Schools were recruited in two cohorts spaced one year apart (2004-2005 and 2005-2006 academic years). Schools from 11 states were enrolled.|
750171|NCT00650546|2 recruitment sites: Department of Gastroenterology, San Antonio Uniformed Services Health Consortium, San Antonio, Texas, USA. Indiana University School of Medicine, Indianapolis, IN, USA|This was a single arm, open label study. Only study group received exenatide treatment. Eight adult patients with known type 2 DM and biopsy-proven NAFLD were treated with 5-10mcg subcutaneous exenatide for 28 week.All eight patients were started on exenatide 5 mcg injections twice a day and the dose was increased to 10 mcg injections twice a day
750172|NCT00650260|Subjects were recruited as they arrived for a scheduled surgical procedure at Tampa General Hospital. Potential subjects were addressed in a private pre-operative room. The investigators or study designee evaluated the patients for the study by reviewing the inclusion and exclusion criteria.|
750173|NCT00650104||Study 101468/196 (this study; NCT#00650104) was an open-label, ropinirole XL (2-24 mg/day), continuation study for participants with Parkinson's Disease who previously completed Studies 167 or 164. Treatment was originally designed to continue for 3 years, but it was extended until ropinirole XL became commercially available in each study country.
750174|NCT00650091|"Initial Study Design: Subjects are randomly assigned to receive a three-drug regimen of prednisone, azathioprine, and acetylcysteine; acetylcysteine alone; or placebo.
~Amended Study Design: The three-drug regimen was removed from the protocol due to safety concerns on 10/14/2011. Subjects are randomly assigned to acetylcysteine or placebo."|Participants in the Pred/AZA/NAC group were discontinued and not re-randomized in the amended study.
750175|NCT00650078|Approximately 350 patients were to be enrolled (at screening, Visit 0), with a minimum of 6 and a maximum of 28 patients at each center. It was planned to randomize (at Visit 1) a total of 294 patients in 50-55 centers in North America and Europe (Germany, Hungary, Poland and UK). First patient enrolled March, 2008; last patient contact May, 2009.|The study consisted of a 1 week screening phase followed by a 12 week double blind treatment phase. In addition to their standard RA medication, patients received placebo during the 1 week screening phase. The purpose of the screening phase was to establish the patient's compliance with study medication and completion of diary entries.
750176|NCT00649961|We conducted an open label dose ranging study between May 2010 and December 2010 in 3 neonatal intensive care units in the UK.|Infants born less than 31 weeks gestation and less than 7 days old were eligible for the study, although those with: major congenital malformation; or cystic periventricular leucomalacia or haemorrhagic parenchymal infarcts on cranial enrolment were excluded.
750177|NCT00649792||
750178|NCT00649428|Patients were recruited between October 23, 2006 and February 9, 2007.|Patients were enrolled and biopsied for manufacture of study product. All randomized patients were included in the Intent to Treat (ITT) population.
750179|NCT00649389|First subject first visit 12 May 2008. Last subject last follow-up 27 Feb 2009. 317 sites in USA and Puerto Rico. Planned: 2400 subjects (600 per treatment arm). Enrolled: 6724 subjects. Randomized: 2492 subjects.|Duration of the study was 57 weeks with 52 weeks of treatment. This included 3-week stabilization/washout (Period I), 12-week double blind treatment (Period II), 40 week open label treatment (Period III), and 2-week post treatment follow-up (Period IV).
750180|NCT00649220||
750181|NCT00648908||
750182|NCT00648895|The recruitment period was from November 2007 to May 2009 at one US location.|All patients went through a 4-5 week, single blind, placebo washout phase before randomization.
750183|NCT00648739||
750184|NCT00648648||206 participants were allocated to one of 28 treatment arms (3 Part 1 arms and 25 Part 2 arms). 8 participants from the Part 1 MK-1775 monotherapy arms continued into Part 2 of the study and received single dose (SD) combination treatment. For disposition purposes these participants are counted under Part 1 only.
750185|NCT00648375||12 subjects were screened for the study. 3 subjects met enrollment criteria and were randomized to study medication.
750186|NCT00648167||
750187|NCT00648115|Veterans recruited throughout medical center|Veterans must have completed a one week follow-up after enrollment to be randomized and included in the analyses.
750188|NCT00648037||
750189|NCT00647998||
750190|NCT00647699||
750191|NCT00647556|Dates of recruitment period: First subject was enrolled on June 17, 2008 and the last subject was enrolled on July 24, 2009.|Wash-out period at baseline: 2 wks topical alpha-hydroxy, glycolic, salicylic, lactic, & beta-hydroxy acids, topical vitamin A, ascorbic acid, vitamin E, corticosteroids on face; 4 wks systemic corticosteroids; 3 mos topical retinoids, superficial chemical peels/exfoliation/microdermabrasion; 6 mos botulinum toxin on the face; 1 yr oral retinoids.
750192|NCT00647426||
750263|NCT00642694||
750264|NCT00642668||
750938|NCT00609804||
750939|NCT00609765||
750195|NCT00647270|The study was conducted at 72 sites in the United States, Canada, Puerto Rico, Germany, the United Kingdom, and Australia. Subjects received over the course of 24 weeks either 80 mg adalimumab monthly, 40 mg adalimumab every other week (eow), or placebo (12 weeks) followed by 40 mg adalimumab eow (12 weeks).|A total of 432 subjects were enrolled, randomized, and received at least 1 dose of study drug. A total of 420 subjects were defined as the Full analysis set (FAS), which excluded the 12 subjects enrolled at a non-compliant site. A total of 48 subjects were switched from placebo to adalimumab 40 mg eow and participated in Period 2.
750196|NCT00646958|This study targeted participants with uncomplicated skin and soft tissue infections (uSSSI) for which oral, outpatient treatment was appropriate. Eligible uSSSIs included simple abscesses, impetigo, folliculitis, furunculosis, carbuncles, and cellulitis (area <10 cm2).|
750197|NCT00646906|"Phase 1a: 16 evaluable healthy individuals and 16 evaluable apparently healthy chronic smokers. Crossover design.
~Phase 1b: 8 evaluable healthy and non-smoking subjects. No crossover.
~Phase 2: 8 evaluable healthy and non-smoking subjects. Crossover design.
~Enrollment from 6/2/2004 to 8/14/2007"|
750198|NCT00646776||Of 85 enrolled participants, 52 participants did not receive the study drug (49 did not meet the study criteria and 3 were not needed as study was fully enrolled).
750199|NCT00646763||
750200|NCT00646646|Recruitment was held at the Clinical Research Unit in Jefferson Towers. There were 65 participants recruited between March 28, 2008 and September 24, 2008. All participants signed a written informed consent and was verified to all the information pertaining to their participation in the study.|A physical examination of each participant was used to assess their success in the study. Participants were excluded if they did not meat the BMI weight requirement and/or wanted to be excluded from the study.
750201|NCT00646581|Subjects were recruited from an urban community mental health clinic.|Subjects who met DSM-IV criteria for schizophrenia or schizoaffective disorder were enrolled in the study (see inclusion/exclusion criteria). Subjects were randomly assigned to either the experimental group or placebo group.
750202|NCT00646399|The first subject was enrolled on 29 Mar 2009 and the last randomized subject completed the trial on 20 Jan 2011. The trial was conducted in the neonatal intensive care unit.|
750203|NCT00646282|Subjects were enrolled from July 2008 to February 2009|Four of the 12 subjects that were consented were withdrawn because they did not meet inclusion criteria or met exclusion criteria.
750204|NCT00646113||
750205|NCT00646048||
750206|NCT00645970||
750207|NCT00645944|The study was conducted between May 2008 and February 2011 at a community mental health center. Following screening and baseline assessment, eligible patients who continued to meet inclusion criteria were randomly assigned to either placebo or eszopiclone in a 1:1 ratio using a randomization procedure blind to both research team and subjects.|179 outpatients were screened, 44 met initial eligibility criteria. Forty-three consented to participate and 4 were withdrawn prior to randomization. Of the remaining 39, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication
750208|NCT00645853|The study population included male and female participants >18 years of age with chronic non-valvular Atrial Fibrillation. The participants were recruited during the time period from 25 October 2007 to 20 May 2008 at medical clinics in Europe.|All participants had previously participated in the Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation (NCT00684307) study
750209|NCT00645840||
750210|NCT00645827|Subjects were enrolled between April 2008 to February 2009.|78 subjects consented. 3 subjects excluded at screening. Of the 75 subjects remaining, only 57 subjects seen by the principal investigator (PI) because the patient's healthcare provider had to call the PI right before the intravenous insulin infusion (III) was discontinued. PI excluded 26 more subjects at III cessation--31 subjects randomized.
750211|NCT00645788|The first visit of the first subject was on 05 May 2008 and the last visit of the last subject on 25 Jan 2011. This study was conducted at 73 centers from 8 countries.|Of all enrolled 486 subjects, 188 had screening failures, the remaining 288 were randomized but 2 subjects (one each in 32.5 mg Ciprofloxacin DPI (Dry Powder for Inhalation) and 48.75 mg Ciprofloxacin DPI groups) did not receive any study drug. A total of 286 subjects received one of the 4 study drug treatments.
750212|NCT00645762|Enrolled patients with chronic rhinosinusitis (CRS) from Ear, Nose Throat (ENT) physician practices.|All patients had transantral balloon dilation of the maxillary sinus ostium and ethmoid infundibulum with the FinESS Sinus System.
750213|NCT00645710||
750214|NCT00645671|A total of 400 subjects, 18 years old or older who were candidates for routine, uncomplicated cataract surgery, were enrolled at 17 investigative sites in the US. First subject was enrolled on 3/14/2008 and last subject visit was 3/23/2009.|Following cataract surgery at visit 3 (post operative day 1), subjects were assessed for eligibility. 201 subjects were randomized to receive loteprednol etabonate ointment and 199 to receive its vehicle.
750215|NCT00645593||
750216|NCT00645567||Although 10 individuals signed ICs, 4 actually actively participated in the study as one was dropped due to an unrelated injury.
750217|NCT00645528|Patients were referred by their primary care provider (PCP) through an electronic consult to participate in an insulin education and initiation group visit. All patients received the same education and standard of care; however, only those subjects who signed an informed consent form and met inclusion/exclusion criteria had their data analyzed.|From April to July 2008, 102 patients were referred to the clinic, and 71 (70%) reported to visit 1. Of these, 32 were excluded: 15 did not bring a glucose log; 7 had HbA1c <8; 1 did not have HbA1c within 1 month; 1 was not referred by PCP; 6 did not consent; 2 were already on insulin. 39 were eligible for the study. 32 completed the study.
750218|NCT00645450||
750219|NCT00645411|Participants were enrolled from 14 sites in Finland, 16 in the US, 9 in Croatia, 5 in Italy, 6 in Lithuania, 2 in Romania, 8 in Hungary.|All subjects enrolled were included in the trial.
750220|NCT00645359||
750221|NCT00645333|Eligible subjects included men or women with metastatic (Stage IV)breast cancer, or with locally advanced breast cancer (Stages IIIA> 10cm, or stages IIIB and IIIC) that did not respond to first-line anthracycline-based chemotherapy.|There must b at least a 6 month interval since prior taxane therapy.
750940|NCT00609739|Only 1 patient was enrolled (yr 1999) and later died (yr 2000). Study was terminated due to low accrual.|
750941|NCT00609674||
750222|NCT00645164|Planned: Approximately 60 evaluable subjects. Analyzed: 59 subjects were enrolled in the study, of which 58 were randomized and received test article. 7 subjects were prematurely withdrawn - 1 prior to receiving test articles; 52 subjects completed the study and were evaluable.|
750223|NCT00645099||Three subjects of the 462 enrolled did not receive study medication and were excluded from analysis: 2 subjects were randomized by mistake by the investigator and 1 subject withdrew consent before first intake of study medication. The ITT population consisted of 459 subjects who took at least one dose of study medication.
750224|NCT00645047||
750225|NCT00644995|Participants were recruited from Group Health, a large regional health plan.Potential participants were identified from automated medical records, mailed study invitation letters, and then contacted by phone to be screened for interest and eligibility.|
750226|NCT00644969||Double-blind treatment phase Week 1 to Week 12. Treatment discontinued at Week 12 and participants continued in Post treatment phase (non-treatment follow up) up to Week 24. Participants could discontinue treatment at any time during treatment phase and remain on study through the non-treatment follow up period.
750227|NCT00644917|This phase 1 study was conducted at one investigational site (Research Laboratory) located in the US, and conducted on healthy adult subjects of either gender, and skin-type I, II, or III, who were 18 years of age and older, from 19-Feb-2008 to 29-Feb-2008.|
750228|NCT00644787||
750229|NCT00644657|Patients scheduled for cardiac catheterization and possible percutaneous intervention who received a loading dose of 300 mg of clopidogrel were recruited.|
750230|NCT00644592|UF Clinical Research Center. Started March 2008, completed August 2009.|Patients were screened for eligibility.
750231|NCT00644423||18 participants enrolled; 11 participants started (randomized at Week 2) after a 2-week placebo lead in
750232|NCT00644358||
750233|NCT00644332|Patients were enrolled at a total of 30 study sites in the US. The first patient was screened on 07 November 2007, and the last patient was screened on 06 December 2010. The last patient observation was on 20 January 2011.|In the 2-week qualifying phase, patients continued antianginal medications without changing dose or frequency and completed questionnaires to document angina symptoms, treatment and status. Patients who had average angina frequency of ≥ 2 attacks/week during this phase and met all enrollment criteria were enrolled in the open-label treatment phase.
750234|NCT00644280|Patients were recruited from the University of California, San Francisco (UCSF) Glaucoma Service|
750235|NCT00644228||
750236|NCT00644189||
750237|NCT00644059|"Participants were enrolled as follows:
~In season 2007/08: 28 active sites in Germany (Excluding Site 023); In season 2008/09: 83 active sites+ 1 coordinating site in Germany, 15 sites in Finland; In season 2009/10: 15 sites in Finland, 2 sites in Italy"|All subjects enrolled were included in the trial. The data entered is for the overall study.
750238|NCT00643916|Participants were enrolled from 10 December 2004 to 14 May 2005 in 15 medical centers in the US|A total of 378 participants that met the inclusion and exclusion criteria were enrolled, 369 were vaccinated.
750239|NCT00643864|Medical outpatient clinic|
750240|NCT00643851|Of 994 participants enrolled, 632 completed a qualification period. Of these 632 participants, 603 were randomized. Of these 603 randomized, 598 received at least one dose of study medication treatment. Of these 598 randomized, 518 completed double-blind treatment period.|
750241|NCT00643760||
750242|NCT00643682||
750243|NCT00643604|The first subject was enrolled in March 2008. Given the limited availability of eligible subjects at the investigative center (stable PH patients on stable epoprostenol therapy) and competition for enrollment by other studies, after an extended recruitment period during which no new subjects were enrolled, the study was subsequently closed.|
750244|NCT00643578|Between April and November, 2008, the UF Asthma Research Lab recruited 37 patients for study.|Of the 37 subjects who signed informed consent, 25 did not meet inclusion/exclusion criteria. The provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second (PC20FEV1) was not less than or equal to 4 mg/mL.
750245|NCT00643565||
750246|NCT00643487||
750247|NCT00643448||All patients will attend a pre-entry Visit 3-28 days before the planned randomisation. At this Visit, the Investigator ensures that a signed Informed Consent Form has been obtained before any study specific procedures are conducted. Patients who have given their consent to participate in the study will then undergo a full clinical assessment
750248|NCT00643279|Recruitment began on March 13, 2003 and ended on November 16, 2004. All subjects were exited from the study on April 8, 2013. Twenty-nine US clinical centers participated in the COMPASS-HF study.|Subjects were required to have a successful implant of the Chronicle® device prior to randomization. 277 subjects had an attempted implant, with 274 successfully implanted and randomized. 3 subjects had unsuccessful implant attempts and were exited prior to randomization.
750249|NCT00643201|First participant, first visit: 27 August 2008; Last participant, last visit: 12 March 2013.|5614 enrolled, 5395 randomized; Reasons for non-randomization: 173 did not meet inclusion/exclusion criteria; 12 withdrew consent; 5 had clinical reason to continue current treatment; 3 administrative reason by sponsor; 1 death; 1 adverse event (AE); 24 other reasons. 1 site (5 patients) excluded from analysis due to unconfirmed accuracy of data.
750250|NCT00643162||4 subjects screen failed; 1 subject withdrew consent after screen. Total of 5 subjects were not randomized.
750251|NCT00643123||8 subjects screen failed; 5 subjects did not qualify at Baseline. 13 total subjects were not randomized
750252|NCT00643097||
750253|NCT00643006||
750254|NCT00642993||
750255|NCT00642954||
750256|NCT00642902||
750257|NCT00642850||
750258|NCT00642811||
750259|NCT00642772||
750260|NCT00642759||
750261|NCT00642746|Enrollment was done from 3/28/2008 to the study closure of 12/19/2011. Patients were recruited from the Oregon Health and Science University medical clinic as well as via referral from associated regional medical clinics.|Patients were stratified according to whether they had received 5-Fluorouracil/Leucovorin with Oxaliplatin or Fluorouracil, Leucovorin, and Irinotecan for their 1st line treatment. Whichever they had not received in the 1st line setting, they received on trial. 16 patients signed consent. 2 patients withdrew, 3 ineligible, and 1 unevaluable.
750265|NCT00642642|Patients were recruited between 7 Nov 2007 and 6 March 2008|Patients were enrolled and biopsied for manufacture of study product. Patients for whom study product could not be manufactured were excluded from the Intent to Treat (ITT) population.
750266|NCT00642616|A total of 517 participants were screened in 5 countries . First participant was screened in March 2009.|2 week screening period followed by a 2 week run-in period. After the screening period, 51 participants were randomized and 34 participants met eligibility criteria after the 2 week run-in period and were treated . Study was terminated based on data safety monitoring board recommendations.
750267|NCT00642603||
750268|NCT00642473||
750269|NCT00642460||This study consists of 3 parts. Part I: a 12 week double-blind placebo controlled study followed by Part II: a 92 week single arm open-label extension study followed by Part III: a 3 year open label continuation study.
750270|NCT00642382|participants were not randomized and did not receive any intervention|
750271|NCT00642369||
750272|NCT00642356||
750273|NCT00642304||
750274|NCT00642278|This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) in patients with type 2 diabetes mellitus with sitagliptin as a reference arm. The study was conducted between 27 March 2008 and 28 January 2009 and recruited patients from 85 study centers located in 13 countries worldwide.|A total of 451 patients were randomly allocated to the 7 treatment arms in the study and comprised the intent-to-treat analysis set which was used for the efficacy analyses. All 451 patients received at least 1 dose of study drug and were included in the safety analysis set.
750275|NCT00642174||
750276|NCT00642018||
750277|NCT00641862||
750278|NCT00641797||
750279|NCT00641745||
750280|NCT00641719|This study, F1J-JE-HMFY (Study HMFY), is an open-label, long-term extension study of double-blind placebo-controlled study F1J-JE-HMFX (Study HMFX) (NCT00552175).|Prior to start of extension study (HMFY), all participants in Study HMFX were re-randomized to duloxetine 40 or 60 mg regardless of the treatment they received in Study HMFX. Baseline values for the extension study HMFY represent those of 40- and 60-mg groups after re-randomization of participants.
750281|NCT00641706|45 patients were enrolled from 28 medical clinics between July 4, 2008 and February 16, 2010.|One patient cancelled prior to treatment initiation and is excluded in the analysis.
750282|NCT00641667||
750283|NCT00641641|Patients were recruited at 5 clinical centres in Sydney|A screening period of less than 42 days prior to commencement of study drugs was employed
750284|NCT00641563||
750285|NCT00641537||A total of 1326 subjects were randomized into CLARITY from study 25643 (NCT00213135), of whom 867 consented to participate in this phase 3b extension Study 27820. 806 subjects were randomized or assigned to treatment and a further 61 subjects were followed for safety only (Supplemental follow-up period [no study treatment] [SAFUP]).
750286|NCT00641147|Subjects were screened and enrolled at the Johns Hopkins Hospital and the University of Puerto Rico Hospital.|
750287|NCT00641108||The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.
750288|NCT00641056||
750289|NCT00641043||
750290|NCT00640978|Recruitment Period: March 2008 through January 20, 2009. All recruitment done at UT MD Anderson Cancer Center.|Of the sixteen registered, one (1) participant was enrolled but did not receive the planned treatment.
750291|NCT00640926|This study targeted adult patients with mild to moderate (i.e., CURB-65 score of 0 or 1) community-acquired pneumonia (CAP).|
750292|NCT00640835|Patient enrollment commenced 02/28/08 and was completed 04/15/08. All sites were medical clinics.|Subjects were required to be on a stabilized dose of buprenorphine and naloxone for at least 30 days prior to study drug administration, either during the screening period, or as part of routine medical treatment during the previous 30 days.
750293|NCT00640822|Date of first subject visit was 5 Mar 2008. Date of last subject visit was 18 Jun 2009. Patients came from hospital outpatient clinics or private practice|Forty-one subjects were not randomised. Most we screen failures or did not have the required extent of disease or withdrew before randomization
750294|NCT00640653||
750295|NCT00640614|3 June 2008 through 17 August 2009|There were no significant events or approaches for the overall study following enrollment but prior to group assignment.
750296|NCT00640601|A total of 331 patients were enrolled across 40 centers in Canada, Australia, Hong Kong and Korea. Out of these 331 enrolled patients, 295 started treatment on seroquel XR. One hundred and eighty three patients completed the 24-week trial.|Patients had to fulfill criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) and their current antipsychotic treatment had to be considered inadequate because of insufficient efficacy, poor tolerance, and/or non acceptability of dosing regimen.
750297|NCT00640562|Adult male and female patients. with a diagnosis of schizophrenia or schizoaffective disorder (according to DSM-IVTR criteria). with depressive symptoms HAM-D baseline score ≥ 20. and HAM-D item 1 score ≥2.|
750298|NCT00640510||One patient randomized to placebo was withdrawn from study by physician and is not included in the baseline demographic data table.
750299|NCT00640393||
750300|NCT00640341|546 subjects (1092 eyes) were planned to be enrolled at 26 investigative sites in the US. First subject enrolled on 2/25/2008 and last subject seen was 4/28/2008.|510 subjects (1020 eyes) were enrolled (all were dispensed). 477 subjects (954 eyes) completed the study. 10 subjects were ineligible at baseline and 23 were discontinued during the study.
750301|NCT00640328||In all 3 dose cohorts, participants in the active/placebo group received treatment with ofatumumab during the First Treatment Period and placebo during the Second Treatment Period. Participants in the placebo/active group received treatment with placebo during the First Treatment Period and ofatumumab during the second treatment period.
750302|NCT00640315||
750303|NCT00640289||
750304|NCT00640250|Dates of recruitment: 16 June 2008 through 7 April 2009. This study was conducted at two investigational sites located in Denmark (E Paulsen) and the United States (J Fowler).|There were no significant events or approaches which caused enrolled participants to be excluded from the trial before assignment to a group.
750305|NCT00640224|Overweight/obese patients with PCOS were recruited from the Children's Hospital of Pittsburgh (CHP) PCOS center and the community through advertisements and flyers posted in the medical campus and in pediatricians' offices.|"9 did not meet diagnostic criteria, 3 were on psychiatric meds,1 was diagnosed with diabetes,1 had venous access issues, and 5 did not complete baseline evaluations. No participants were enrolled in the Overweight/Obese without PCOS or Lean without PCOS Arms/Groups."
750306|NCT00640146||"A total of 37 participants were randomized in 1:1 ratio to receive either methylnaltrexone (MNTX) or placebo. Originally, participants were receiving treatment for up to 7 days. Then, after Protocol Amendment 1 (12 March 2008), the duration of treatment was changed from up to 7 days to up to 4 days."
750307|NCT00640133|The study is a parallel controlled design. Patients (n=27) were assigned to a condition by site & gender via urn randomization to receive three months of double-masked sham or double-masked active DBS. After 3 months, all patients received open-label active DBS. 12 patients were in the sham group while 15 patients received active DBS immediately.|
750308|NCT00640042||
750309|NCT00640016||
750310|NCT00639860||
750311|NCT00639769|Recruitment period = 2/27/2002 through 5/9/2006|A total of 41 people signed consent to take part in this study, of those, 1 was determined to be ineligible.
750312|NCT00639717||
750313|NCT00639678|Participants were randomized to a treatment group at a ratio of 3:1 (raxibacumab:placebo). Participants were randomized to the double dose cohorts first. When randomization was completed for the double-dose cohorts, participants were then randomized into the single-dose cohorts.|A total of 322 participants were randomized and 320 participants were administered at least one dose of study treatment.
750314|NCT00639626||PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
750315|NCT00639509|Protocol Open to Accrual 03/06/2008 Primary Completion Date 02/08/2011 Recruitment Location is medical clinic|
750316|NCT00639457|HIV-infected men and women (18 - 60 yr old) were recruited from the AIDS Clinical Trials Unit, the Infectious Diseases Clinic, and the Volunteers for Health Program at Washington University School of Medicine, St. Louis MO between Jan 2005-Dec 2010. Participants were randomly assigned (1:1) to 4 mo of pioglitazone with or without exercise training.|Exclusion: AIDS diagnosis, non-compliant with anti-HIV medications, unstable CD4+ T-cell count or plasma HIV viremia, illegal drug abuse.
750317|NCT00639418|This study of 118 physician offices in the USA identified the number of patients per practice by age group. A baseline survey and semi-monthly surveys of number of influenza vaccination doses given, staff attitudes toward influenza vaccination, and activities to increase influenza vaccination coverage were completed.|While a total of 147494 children were vaccinated in participating physicians' offices, no subjects were actually treated in this observational study.
750318|NCT00639379||
750319|NCT00639223||
750320|NCT00639158||One subject was randomized to the atorvastatin and ezetimibe treatment group and never received study drug.
750321|NCT00639093|Medical clinic in the province of Quebec.|
750322|NCT00639002||
750323|NCT00638989||
750324|NCT00638963||
750325|NCT00638937||
750326|NCT00638924||
750327|NCT00638885|Subjects recruited through Vietnam Era Twin Registry 2001-2012.|Subjects studied at baseline with no interventions.
750328|NCT00638846||
750329|NCT00638820||This study was terminated early due to stopping rules. The first 3 patients enrolled died by Day 100 of study.
750330|NCT00638716||
750331|NCT00638690||
750332|NCT00638651||
750333|NCT00638508||
750334|NCT00638456||
750335|NCT00638443|Participants were recruited from the Neuromedicine Pain Treatment Center between May 2008 and February 2010|33 participants recruited; 4 excluded (did not meet inclusion criteria based on evoked pain being less than moderate intensity during treadmill ambulation).
750336|NCT00638404|200 Elective cesarean sections and 100 gynecological patients were enrolled prior to their surgery with presurgical testing completed. All subjects were then also seen postoperatively for followup|no randomization, only observational study
750337|NCT00638378||
750338|NCT00638365|This was a multicenter, randomized, double-blind, placebo-controlled safety and PK study.|Two cohorts of subjects were randomized 2:1 and received a single intravenous (IV) infusion of KB001 or Placebo. Cohort 1 received KB001 at 3 mg/kg. Cohort 2 was enrolled at 10 mg/kg. The Placebo groups were combined for analysis.
750339|NCT00638274||
750340|NCT00638235|"Phases duration:
~Phase I: May 2006 - Oct 2009 Phase II: Feb 2007 - Jun 2010 Phase III/IV: Apr 2007 - May 2010 Phase V: Apr 2008 - Jan 2011 Phase VI: Oct 2008 - Mar 2010 Phase VII: Apr 2009 - Feb 2012"|Only those subjects who meet all study criteria, provide written consent and are implanted with an AMS PFR System device for prolapse repair will be considered evaluable for analysis in the study
750341|NCT00638222||
750342|NCT00638183||
750343|NCT00638157||
750344|NCT00638027|Recruitment for the trial began in June 2006 and ended in June 2008. The last subject formally completed the trial in September 2008|
750345|NCT00638014|Subjects were consented and enrolled in the study at 2 centers from April 2008 to July 2009.|Overall 53 subjects were consented and enrolled in the study from April 2008 to July 2009. Two patients were not included in the analysis (1 patients' surgery was cancelled, 1 patient was not randomized due to logistical reasons), leaving a total of 51 subjects who were included in the modified intent-to-treat analysis.
750346|NCT00637923|This study recruited patients from 13 study centers in the United States, including 2 Veterans Administration hospitals.|
750347|NCT00637806||After screening, eligible subjects were randomized to treatment in the double-blind phase. After completing the double-blind phase or discontinuing due to specific weight loss criteria, eligible subjects could enter an open-label extension phase.
750348|NCT00637780|The last participant enrolled in 2014 but the study was kept open for another 2 years and enrollment was not stopped. However, by 2016, no additional participants were enrolled and thus the study was closed. As such, the basic results for this study are only prepared in 2016 though last participant's last visit was in 2014.|
750942|NCT00609622||
750349|NCT00637728||After screening, eligible subjects were randomized to treatment in the double-blind phase. After completing the double-blind phase or discontinuing due to specific weight loss criteria, eligible subjects could enter an open-label extension phase.
750350|NCT00637572||
750351|NCT00637494||
750352|NCT00637416||
750353|NCT00637377|The study was conducted at 186 study centers in 26 countries. Recruitment period: 21 Apr 2008 - 4 Sep 2009.|2031 participants were screened, 1240 were randomized and 1204 received at least 1 dose of study drug. 1204 participants were included in the Safety-Analysis Set (SAS). 1202 participants with at least 1 post-baseline measurement were included in the Full-Analysis Set (FAS).
750354|NCT00637312||
750355|NCT00637299||
750356|NCT00637273||
750357|NCT00637247|Recruitment period was from April 2008 to May 2009. Enrollment occurred at 34 clinical centers in the United States.|
750358|NCT00637195||
750359|NCT00637156||
750360|NCT00637000|Patient enrollment commenced 03/19/08 and was completed 09/19/08. The study site was an in-patient research-based clinic affiliated with Johns Hopkins University School of Medicine.|During screening run-in, subjects received 30 mg morphine subcutaneously up to 4 times/day for up to 13 days. Subjects underwent two test sessions, consisting of a challenge of naloxone (0.4 mg) or placebo intramuscularly and evaluation for the severity of withdrawal. Subjects able to detect withdrawal were randomized to treatment.
750361|NCT00636987||
750362|NCT00636961||
750363|NCT00636818||
750364|NCT00636805||
750365|NCT00636792||
750366|NCT00636701||
750367|NCT00636675|We invited 69 nursing homes (NHs) with > 89 beds participating in Medicare and Medicaid within 100 miles of Duke, and included the first 24 homes responding. Staff were invited as part of their facility's quality improvement (QI) initiatives. We used a random sample of 50 residents from each facility for chart abstraction.|
750368|NCT00636649|This study was conducted at Duke University Medical Center and Saint Louis University between 2008 and 2010.|
750369|NCT00636636|Recruitment period was from March 2008 through May 2009.|Study included screening visit, wash-out from all PHN medications as necessary, followed by a week of baseline period. Patients who successfully completed the baseline week, if still continues to meet entry criteria, then get randomized to Active or Placebo groups.
750370|NCT00636610||
750371|NCT00636506||76 subjects enrolled; 6 withdrew consent prior to the procedure, and 1 had the procedure aborted. 69 subjects were implanted with the study device; of these, 60 completed the study, 8 were lost to follow-up, and 1 had their device explanted.
750372|NCT00636441||
750373|NCT00636389||
750374|NCT00636363|541 participants were enrolled in this 3 month study (1152 eyes). First participant was enrolled Mar 7, 2008 and last participant exited Aug 1, 2008. Participant were enrolled from 24 investigative sites in the US.|Of the 541 participants enrolled 6 were ineligible at baseline. These subjects met the exclusion criteria. 535 participants participated in the study.
750375|NCT00636220|Recruitment time period was from March 13, 2008 to July 1, 2008. All enrollment was at the Evelyn Jordan Center, University of Maryland Baltimore (UMD).|
750376|NCT00636207|Participants were recruited from 3 study sites located in the United States.|
750377|NCT00636194|361 subjects (722 eyes) who are currently adapted silicone hydrogel contact lens wearers and are habitually using a lens care product for disinfecting lenses, were enrolled in this 2-Week study at approximately 14 investigative sites in Asia. Study start date was 2/16/2008 and last subject exited on 3/17/2008.|Fourteen Investigators enrolled 361 subjects in the study. Of these subjects, 347 successfully completed the study, 3 discontinued and 11 were ineligible at baseline, but were dispensed study materials
750378|NCT00636181|Patients who completed routine clinical diagnostic visit and CPAP titration polysomnography (PSG) at 5 international sleep centers were consecutively recruited for the study. These patients were approached with information on the study and were asked to consent to participate.|168 participants were enrolled into the study. However 4 participants were excluded from the analysis and demographic data because they withdrew from the trial prior to any study procedures.
750379|NCT00636168||Protocol definition of Enrolled population: All 1211 participants who signed the Informed Consent Form; 951 were randomized to treatment and 945 were treated. Reasons for not being randomized: 193 were ineligible; 42 refused; 19 could not be randomized within 12 weeks after complete lymph node dissection; 6 due to other reasons.
750380|NCT00636155|All patients were enrolled from Duke University Medical Center.|
750381|NCT00636077||
750382|NCT00635999|Principal diagnosis of GAD, no panic disorder, Clinician's Severity Rating (CSR) for GAD of 4 or more, absence of concurrent therapy, no history of having received CBT methods in prior therapy, no medical contributions to the anxiety, no antidepressant medication, and absence of severe MDD, substance abuse, psychosis, and organic brain syndrome.|
750383|NCT00635882||
750384|NCT00635830||
750385|NCT00635817|Eighteen sites in the US and 4 sites in Puerto Rico enrolled subjects into the study. The first subject was randomized 17 June 2008 and the last subject was randomized 12 Aug 2009.|Subjects were randomized in a 1:1 ratio to 1 of the 2 treatment arms. To ensure balanced randomization, the study drug assignment was stratified on the basis of whether subjects were treatment-naive or had been treated with GnRHa previously.
750386|NCT00635804|Panel H, planned for GT1a/GT1b HCV-infected male participants to receive 400 mg MK-3281 orally BID for 7 consecutive days, did not enroll any participants. As pre-specified by the protocol, it was possible that some panels would not be enrolled if study objectives were met with prior doses.|60 participants were enrolled in this study and received MK-3281 or placebo in Panels A through G.
750387|NCT00635778|This study enrolled participants with metastatic or locally advanced solid tumors, associated with insulin-like growth factor receptor type 1 (IGF-1R) protein expression, that have failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. Other inclusion/exclusion criteria applied.|
750388|NCT00635739||
750389|NCT00635700||
750390|NCT00635661||
750391|NCT00635648||
750392|NCT00635609||
750393|NCT00635570|We recruited 276 participants between March 2006 and December 2008 at two Midwest university-based sites through passive (online and subway advertisements) and active recruitment (referrals from local clinics and health care providers).|We screened 276 participants, of whom 273 were eligible because 3 of them did not meet inclusion criteria.
750394|NCT00635492|"This observational study was conducted at 322 study centers in 6 countries (Belgium, Denmark, France, Germany, Greece, Sweden).
~Date of first patient enrolled: 25 January 2008 Date of last patient completed: 01 December 2011"|2515 patients enrolled. 2388 patients in final analysis (22 not in either cohort), excluded: 92 had no investigator signature on summary page, 11 had no treatment start date, 2 had issues with their informed consent to release their data.
750395|NCT00635479||
750396|NCT00635453||
750397|NCT00635427|The first participant was enrolled in the study on 13 March 2008 and the last participant completed study procedures on 28 December 2012.|2 participants who did not have type 1 Gaucher disease were withdrawn from the intent-to-treat (ITT) set as per the statistical analysis plan and removed from the long-term efficacy analyses in this study, needed to support the interpretation of the long-term efficacy results. Hence, 93 of 95 participants were included in the HGT-GCB-044 ITT set.
750398|NCT00635362|Location: Two urban academic medical centers from both pre-natal and Labor & Delivery clinics Dates: May 2007-January 2011 Inclusion: Pregnant, English-speaking women, aged 18 years and older, with planned cesarean delivery, and desiring the LNG-IUS were eligible for the study.|
750399|NCT00635349||A total of 143 participants were given informed consent, out of which 3 participants had screening failure.
750400|NCT00635232||All subjects were weaned off all antihypertensive medication prior to be entered into a 4-week single-blind placebo run-in period. Subjects had to have eligible Seated systolic and diastolic BP measurements during the single-blind placebo run-in phase to be eligible for the double blind portion of the study.
750401|NCT00635219|The patients were recruited from psychiatric settings.|The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind downtaper period (Week 9); and a 4-week Safety Follow-up Period - the 4-week period after completion/withdrawal (Weeks 9 to 12).
750402|NCT00635167||
750403|NCT00635154|"55 patients were recruited from November 2002 through December 2007 at Mayo Clinic.
~One patient had progressive disease prior to starting treatment. This patient was excluded from all analysis."|Patients received induction therapy of Anakinra alone for 6 months. Based on response, dexamethasone could be added or increased in subsequent cycles. See the Outline section for more detail. Unless otherwise stated, results are reported for all patients (regardless of dexamethasone administration).
750404|NCT00635128||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
750405|NCT00635102|Alcoholic subjects were recruited from the Substance Abuse Treatment Program at VA Connecticut Healthcare Systems in West Haven, through advertisements in newspapers and postings in the community. Healthy subjects were recruited from the advertisements in newspapers and postings throughout the community.|
750406|NCT00635089||
750407|NCT00635050||
750408|NCT00635024|One (1) patient was recruited from May 2008 to September 2008 at Mayo Clinic. This trial was permanently closed in March 2009 due to competing trials.|
750409|NCT00634972||
750410|NCT00634933||
750411|NCT00634920||The study consisted of 2 periods, period 1: TX to Week 7 ± 7 days post-TX and period 2: Week 7 ± 7 days post-TX to Month 36. 341 patients were enrolled in this study. 204 randomized to receive study treatment: 104 in the everolimus group, 100 in the control group. 2 patients in everolimus group did not receive at least one dose of study treatment.
750412|NCT00634907|Patients planning total hip or knee replacement surgery at the University of Utah Hospital, will be approached about participation in the study by Dr Chris Peters, MD or assigned orthopedic staff at the pre-operative office visit at the University of Utah Orthopaedic Center. Patients were enrolled from 9/27/06 - 10/2/08|"Exclusion Criteria:
~Blood transfusion in previous two weeks
~Participant is already taking warfarin
~Pre-operative INR > 4.0
~Pre-operative bilirubin > 2.4 mg/dL
~Current active cancer diagnosis with ongoing treatment
~Concomitant medications known to exert a major interaction with warfarin"
750413|NCT00634842|69 sites in the United States of America (USA).|Subjects were randomised 1:1 to 2 FPG (fasting plasma glucose) titration targets. Insulin doses were self-titrated every three days based on self-measured FPG levels as follows: -3 units if FPG was below the lower limit of the target range, no change if FPG was within target range, and +3 units if FPG was above the upper limit of the target range.
750414|NCT00634803||
750415|NCT00634751|This study accrued through the Wisconsin Oncology Network (WON), a network of academic and private practice institutions across the state of Wisconsin and the upper Midwest.|
750416|NCT00634647||
750417|NCT00634621||
750418|NCT00634582||
750419|NCT00634569||
750420|NCT00634543||
750421|NCT00634504||
750422|NCT00634322||
750423|NCT00634283|All 142 research subjects were enrolled at the Laboratory of Brain, Behavior and Pharmacology from 8/19/05-9/30/08.|Subjects were required to wash out from any exclusionary medication for at least two weeks. Subjects taking fluoxetine were required to wash out for at least 30 days prior to treatment assignment.
750424|NCT00634270|Existing and NF1 new patients at Consortium sites and partnering with the Children's Tumor Foundation.|Eligibility for Stratum 1 if evidence of progression and Stratum 2 if not evidence of progression.
750425|NCT00634244|This study was activated on October 16, 2008 and closed on August 2, 2013 with a total of 92 patients accrued. Duration the response evaluation after meeting the first stage accrual goal, Arm C did not meet the criteria to continue onto the second stage and was closed to accrual at that time.|
750426|NCT00634179|All patients were recruited from Winship Cancer Institute of Emory University.|A total of 37 patients were enrolled. However, not all patients participated in both phases of this study. For phase I, 19 patients were enrolled, and for phase II, 30 patients were enrolled.
750427|NCT00634166||
750943|NCT00609609|Recruitment Period: January 23, 2008 to November 19, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
750428|NCT00634114|Enrolment 8Jan08-19May09. 564 randomised participants, 563 in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy. SAS for summaries of safety. 1 pt. in Omep. 10 mg excluded as they took no investigational drug. Nos. for gender were 188 in Esom. 20 mg, 188 in Esom. 10 mg and 187 in Omep. 20 mg.|Out of 578 enrolled participants, 564 participants were randomised and 14 participants were not randomised. The reasons of no randomisation were 'Incorrect enrolment' (11 participants) and 'Voluntary discontinuation by participant' (3 participants).
750429|NCT00634101|A total of 129 subject were enrolled into this study. Of those enrolled, all were assigned to a study lens, however, only 125 eligble to be dispensed. Of those dispensed, 117 subjects completed the study. However, this study was utlimately terminated.|
750430|NCT00634088||Of 13 participants enrolled, 10 received treatment with ixabepilone + lapatinib in escalating-dose cohorts. No participants were enrolled in the ixabepilone + lapatinib + capecitabine cohort due to premature termination of the study.
750431|NCT00634049|Consenting adult participants with proven, probable or possible invasive aspergillosis and renally impaired (RI) or of participants with invasive fungal disease (IFD) caused by rare moulds, yeasts or dimorphic fungi meeting the inclusion and none of the exclusion criteria were considered for entry into the study.|Analysis and interpretation of the results was pathogen dependent and each pathogen was quite rare, therefore it was not feasible to enroll a sufficient number of participants in a randomized controlled trial to power the study adequately to allow statistical comparisons.
750432|NCT00634036||
750433|NCT00634010|Recruitment period: February 22, 2008 to September 14, 2010. All recruitment done within medical clinics at The University of Texas MD Anderson Cancer Center and Lyndon Baines Johnson Hospital.|
750434|NCT00633984||
750435|NCT00633945||The sample size was determined by the number of study subjects for whom Celgene Corporation was willing to supply medication during and beyond the study period. It was felt that 5 study subjects would provide valuable information about the responsiveness of severe CLE to lenalidomide (REVLIMID®) and subjects' tolerability to the study medication.
750436|NCT00633932|First subject enrolled on 11 December 2007. Last subject completed on 12 December 2008.|Out of 602 enrolled subjects, 572 subjects were randomised and 30 subjects were not randomised. The reasons of no randomisation were 'Incorrect enrollment' (25 subjects) and 'Voluntary discontinuation by Subject' (5 subjects).
750437|NCT00633919|First subject first visit: 22 June 2006|
750438|NCT00633893|First participant, first visit: 16 May 2008; Last participant, last visit: 24 August 2012.|2711 enrolled/2482 randomized: 133 did not meet inclusion, exclusion criteria; 48 withdrew consent; 8 non-compliance; 3 each administrative and clinical reasons; 2 lost to follow up; 1 death; 1 adverse event (AE), 30 other. Data from 4 participants in site 0650 not analyzed/included in randomized population because source for data not confirmed.
750439|NCT00633880||
750440|NCT00633867|adult patients undergoing elective tracheal intubation at induction of anaesthesia Between February and August 2008|139 patients consented for study. 120 assigned to groups. 19 not studied: no McGrath® scope available (n=10). No direct supervision of intubator (n=6). Case cancellation or changes (n=3).
750441|NCT00633750|Recruitment period = 8/28/2002 through 10/16/2007|54 participants were initially consented for this study. Four were determined to be ineligible. Three participants withdrew from the study before beginning.
750442|NCT00633594||
750443|NCT00633477|Participants took part in the sudy at 11 centers in Japan and 1 center in the United States from 26 February 2008 to 20 February 2009 (day the decision was taken to terminate the study) .|Participants who met 3 of the 4 systemic inflammatory response syndrome (SIRS) criteria and receiving parentaeral antimicrobial therapy for bacterial or fungal infection prior to enrollment and met the key organ failure criteria within 36 hours of planned study drug administration were randomized to receive resatorvid or placebo.
750444|NCT00633464||
750445|NCT00633399||458 patients met eligibility criteria for the study and were enrolled in an 8-week, open-label, flexible dose trial of escitalopram. At the end of this open-label trial, 139 patients not responding to Escitalopram were randomized to receive adjunctive ziprasidone or adjunctive placebo.
750446|NCT00633360||
750447|NCT00633256||
750448|NCT00633243|Subjects were recruited over a 3-year period (2007-2010) from a substance abuse treatment clinic in New Haven, CT. Those with evidence of infection with HCV were subsequently seen by a medical provider to evaluate for HCV treatment, and if found to be appropriate, were referred to the research assistant.|Subjects were eligible for participation if they were prescribed methadone and were opioid negative in the past 30 days, age 18 years or older, underwent documented HIV testing, competent to provide informed consent, had stable mental health status, and met the following criteria for HCV treatment: detectable HCV RNA and genotype testing.
750449|NCT00633217||
750450|NCT00633152|Twelve (12) study centers in the U.S. participated in this open label trial.|
750451|NCT00633139|Children with an established diagnosis of late metachromatic leukodystrophy (MLD) due to arylsulfatase A (ASA) deficiency were recruited.|All participants that completed study recombinant human arylsulfatase A (rhASA-01) (NCT00418561) except 1 participant who did not complete (at week 18) the rhASA-01 (NCT00418561) participated in HGT-MLD-048/rhASA-03 (NCT00633139).
750452|NCT00633126||
750453|NCT00633087|Twelve subjects were enrolled from April 2007 through June 2009 at The Cancer Institute of New Jersey, a comprehensive cancer center.|
750454|NCT00633074||
750455|NCT00633061|"Recruitment from June 2008 to December 2010. For arm A, we screened 486 children and enrolled 136. 68 patients were eligible and not enrolled and 282 were ineligible.
~No patient was eligible for Arm B of this study"|
750456|NCT00633022|Participants with established atherosclerosis were planned to be enrolled across 4 sites in the United Kingdom from 02 June 2008 to 03 December 2009. Participants were screened within 45 days prior to the first dose and underwent radiological scan within 14 days prior to the first dose.|Participants were randomized in the study to receive oral dose of Losmapimod 7.5 milligram (mg) twice daily, Losmapimod 7.5 mg once daily or placebo.
750457|NCT00633009||
750458|NCT00632970||
750497|NCT00631007||Patients 30 - 75 years of age with type 2 diabetes mellitus with inadequate glycemic control (HbA1c ≥7.5% and ≤ 10% and a Fasting Plasma Glucose <240 mg/dL) at screening on sulfonylurea monotherapy or sulfonylurea plus metformin were eligible to enter the study.
750459|NCT00632931|"Eric Rubin, M.D., The Cancer Institute of New Jersey, New Brunswick, New Jersey; Pamela Munster, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida; Prof. Dr. Simon van Belle, University Hospital of Ghent, Ghent, Belgium.
~Dosing initiated on 16-Jul-2007 and completed on 05-Feb-2009."|Enrolled patients were assigned to 1 of 2 dose sequences (vorinostat then placebo or placebo then vorinostat) in Part 1 of the study to determine the effect of vorinostat on the QTcF (Fridericia-corrected QT) interval. Following Part 1, active patients continued into Part 2, daily dosing of vorinostat.
750460|NCT00632827||
750461|NCT00632814|The recruitment period took from first patient first visit 28 Jun 2007 to last patient first visit 26 Dec 2008. The study period took from first patient first visit 28 Jun 2007 to last patient last visit 27 Sep 2009. All 4 sites were medical clinics. Assignment to a group was based on patients previous treatment schedule (non-randomized).|There was an indefinite time period between screening and baseline. Study treatment started at visit 2 (baseline).
750462|NCT00632749|68 participants were entered, and 64 were treated with the study treatment|
750463|NCT00632736||Study 101468/248 (this study, NCT00632736) was an open-label extension study with ropinirole extended release (XL) for subjects from studies 101468/165, 101468/168, and 101468/169 (NCT00381472).
750464|NCT00632632||
750465|NCT00632619|Subjects were recruited as two cohorts- 50% in each wave. Wave one was recruited in Buffalo NY in the summer of 2009, from referrals from local pediatricians and therapists and mailings to families. The study was then moved to Florida International University where the second cohort was recruited from 9/10 to 12/10 using similar procedures.|Subjects were assessed at intake on the current ADHD medication regimen to make sure that they needed additional treatment beyond what they were currently receiving. There was no washout prior to enrollment.
750466|NCT00632541||
750467|NCT00632502||Participants were considered to complete the study if they completed the follow-up visit, whether or not they completed treatment.
750468|NCT00632489||
750469|NCT00632463|Patient recruitment period took place between 06Jun2008 and 05Mar2010. Patient recruitment took place in hospitals.|
750470|NCT00632424||23 participants enrolled in this study; five participants were never treated due to not meeting study criteria (n=4) and withdrawal of consent (n=1).
750471|NCT00632411||
750472|NCT00632359|Recruitment Period: February 28, 2008 to January 7, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|
750473|NCT00632281||
750474|NCT00632229|Thirty-four adults with a principal diagnosis of OCD were recruited between May 2008 and March 2012.|
750475|NCT00632203||
750476|NCT00632125||
750477|NCT00632099||
750478|NCT00632021|Adults admitted to Vanderbilt University Hospital or Brigham and Women's Hospital for acute coronary syndromes or acute decompensated heart failure were enrolled between May 2008 and September 2009. We enrolled and randomized 862 patients. Eleven patients withdrew consent or died in the hospital, leaving 851 patients in the analysis.|This was a randomized, controlled trial with concealed allocation and blinded outcome assessors. We enrolled and randomized 862 patients (430 intervention and 432 usual care). Eleven patients (7 intervention and 4 usual care) withdrew consent or died in the hospital, leaving 851 patients in the intention-to-treat analysis.
750479|NCT00631969|Subjects recruited to 40 investigational centers in Belgium (4), France (8), Germany (9), Spain (3), Netherlands (5), and South Africa (11). First patient first visit on 25 April 2008, last patient last visit on 19 January 2009.|409 male subjects screened (<65 years: n=185; >=65 years: n=224), 362 randomized to treatment (186 to Vardenafil ODT, and 176 to placebo). The main efficacy analysis set was the Intent-to-treat (ITT) population (randomized treated subjects with baseline and post-baseline efficacy and safety assessments); 183 on Vardenafil ODT and 172 on placebo.
750480|NCT00631917||
750481|NCT00631748|Participants with a diagnosis of cocaine dependence were recruited from the VA Puget Sound Health Care System and the local community.|A screening visit was conducted to ensure that they met inclusion/exclusion criteria for the study. If they met criteria, they were scheduled for a baseline visit, during which they were randomized to either the quetiapine or placebo arm of the study.
750482|NCT00631696|Study was conducted at 12 centers in the United States between February 2008 and February 2012; 903 participants were screened and 222 were assigned to study treatment.|
750483|NCT00631670||
750484|NCT00631657||
750485|NCT00631566|HIV-infected adults from four US Military HIV clinics were prospectively enrolled during routine visits. Enrollment occurred between May 2007 and May 2010 and follow-up visits were conducted until August 2012.|
750486|NCT00631540||
750487|NCT00631488||Participants received matching placebos to MK-0893, Sitagliptin, and Metformin during a 2-week run-in period.
750488|NCT00631475|Patients were enrolled at 61 centers in 15 countries (Australia, Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, South Korea, , Spain, Switzerland, UK, and USA. The first patient started on 5 March 2008 and the last patient, last visit was on 01 April 2010.|In total, 128 of the 615 patients who received randomized treatment in BUILD 3 (NCT00391443) rolled over into the BUILD 3 OL extension.
750489|NCT00631449||
750490|NCT00631410||
750491|NCT00631371|Approximately 800 participants enrolled in this study at 200 sites.|Participants were randomized in a 1:1 ratio, stratified by prior nephrectomy status (yes/no) and Memorial Sloan Kettering Cancer Center (MSKCC) risk factors (good/intermediate/poor), and received either the combination treatment of Temisirolimus + Bevacizumab (Temsr+Bev) or Interferon-alfa + Bevacizumab (IFN+Bev).
750492|NCT00631358|Patients were recruited via flyers, newspaper advertisements, radio advertisements and chart review in the doctors' office.|
750493|NCT00631319||
750494|NCT00631189|Patients were recruited by general practitioner. First patient included: 12 October 2007 Last patient terminated the study: 04 October 2008|This French multicentre, randomized double-blind study was conducted on three parallel arms. The 14-week study comprised 3 visits: a screening visit (week 0, V1), a randomization and treatment allocation visit (week 6, V2) and an evaluation visit (week 14, V3). Patients were randomized at V2 and were treated for a period of 8 weeks.
750495|NCT00631137|outpatient clinic|
750496|NCT00631020||
750499|NCT00630955|Participants were recruited from May 2006-May 2011 using posted advertisements in the local newspaper and brochures and other materials distributed in the community (bars, coffee shops, grocery stores).Electronic media and social networking were also used, including Craigslist and Facebook.|
750500|NCT00630916||
750501|NCT00630877|Subjects were enrolled at 41 sites in the United States between February and June, 2008.|Of the 276 subjects that were randomized, 5 discontinued from the study prior to receiving study drug due to withdrawal of consent (2), death in the family (1), positive pregnancy test (1), and lost to follow up (1).
750502|NCT00630864||
750503|NCT00630838|All participants scheduled for endorectal pullthrough who were consented were randomized, but 1 died following the surgery prior to any study specific placebo usage.|
750504|NCT00630825||
750505|NCT00630812||Patients underwent a mannitol tolerance test (MTT) to gauge tolerance to a test dose of mannitol. 318 patients were then randomised - only 305 of the randomised patients went on to receive a dose of study medication. Patients who did not start medication (13) were not included in the modified ITT population (mITT)
750506|NCT00630786|Participants were enrolled from 12 January 2008 through 6 November 2008|
750507|NCT00630747|This study allows participants in double-blind phase of Study TKT024 (NCT00069641), a 1 year Phase 2/3 registration study, to continue long-term idursulfase therapy and to allow placebo participants in TKT024 to receive active idursulfase treatment. The first participant enrolled on 13 Sep 2004. The study was conducted at 52 sites in 17 countries.|Participants were screened for entry based on their known medical histories and previous participation in the TKT024 study. Participants had to have completed Week 53 final evaluations in the TKT024 study. Participants were not to have received any treatment with an investigational therapy other than idursulfase within 60 days of study entry.
750508|NCT00630734|Healthy volunteers were recruited from the Denver metro area between March 2008 and September 2009.|Participants were genetically screened for solute carrier organic anion transporter family, member 1B1 (SLCO1B1) diplotypes as follows: Group 1, *1A/*1A (reference diplotype); Group 2, *1A/*1B or *1B/*1B diplotypes; and Group 3, subjects with at least one copy of the *5, *15, or *17 haplotype.
750509|NCT00630539|The study was conducted at 9 centers in Finland. First patient was enrolled on August 09, 2007 and last patient completed on February 11, 2008|The study population included postmenopausal women 40 to 80 years of age with a diagnosis of vulvar and vaginal atrophy (VVA) assessed by the maturation index (MI) of vaginal smear and vaginal pH at baseline
750510|NCT00630487|Study Initiation and Completion Dates: 26 May 2008 to 17 October 2008. The study was terminated prematurely.|Nine patients were enrolled, but no patients were randomized due to early termination of study.
750511|NCT00630409||
750512|NCT00630396|Recruitment occurred from June 3, 2008 to October 10, 2009. The study was completed ahead of schedule. Study subjects were enrolled in each recruiting centers' Emergency Department or stroke intensive care unit. Many subjects came as transfers from rural or outside hospitals to one of the enrolling centers for further care and study participation.|Potential patients that met all of the inclusion criteria, did not meet any of the exclusion criteria, and were willing to participate were enrolled in the study. All study subjects were given one of the four doses of minocycline. The dose of minocycline given was assigned by a computer program.
750513|NCT00630344||
750514|NCT00630331|Participants were enrolled at multiple centres in the US, Poland and Finland.|All enrolled subjects were included in the trial.
750515|NCT00630305|Total of 37 subjects enrolled, with two being discontinued. Thirty-five (35) subjects were recruited to a single site, where eligibility was confirmed and informed consent discussed and when appropriate signed.|Subjects were randomized to go to all four sessions (A, B, C and D) in a random order. Once in a session subjects were further randomized to one of four contralteral lens sequences (right eye / left eye).
750516|NCT00630292||
750517|NCT00630058||
750518|NCT00629850||
750519|NCT00629772||
750520|NCT00629707||
750521|NCT00629525||
750522|NCT00629499||
750523|NCT00629265|170 subjects were recruited/randomized into the study from 16 medical centers in the United States between January 2009 and December 2011. The majority of subjects were recruited during follow up visits in outpatient Otolaryngology & Radiation Oncology clinics.|All potentially eligible patients were screened with a 19 question eligibility form. 488 patients were screened, of which 318 were not eligible or declined to participate. 170 patients were then randomized to either the Active NMES + Swallowing Exercise group or the Sham (inactive) NMES + Swallowing Exercise group.
750524|NCT00629239|One participant was excluded in the analysis sets since this participat is non-informative both in terms of efficacy and safety, and was immediately withdrawn for non-treatment related reasons. AZD4818 Turbuhaler group will include 33 patients in all other sections|
750525|NCT00629122||
750526|NCT00629083|The first subject was enrolled on June 4, 2008, and the last subject was enrolled on June 6, 2011. All participating study centers were in hospitals or clinics in the United States, Canada or France. The sites and investigators were qualified to treat stress urinary incontinence in women by experience and expertise.|Pelvic Organ Prolapse Quantification, upright cystometry, Valsalva Leak Point Pressure, post-void residual measurement, daily number of incontinence episodes and a 24-hour pad test were completed prior to randomization to confirm eligibility in the trial.
750527|NCT00629018|This study consisted of an open-label randomized study design conducted at the Advanced Heart Failure and Transplantation Center at University Medical Center Ljubljana in collaboration with the Methodist DeBakey Heart Center and Stanford University.|Patients with acute multi-organ failure or history of haematologic neoplasms were not included.
750528|NCT00628927|As an ancillary study to CTN-0031, six of the nine sites participating in CTN-0031 were chosen to participate in the present study. At the participating sites, participants who were randomized into CTN-0031 were eligible to be screened for the present study. Normal controls were recruited via advertising from one study site.|6 stimulant abusers met at least one exclusion criterion, 3 for a history of stroke and 3 for a history of seizures. 2 of those 6 were incorrectly enrolled into the study. The most common exclusion criteria met by the normal control screeners was having a DSM-IV substance use diagnosis and positive urine toxicology screen.
751108|NCT00602771|January 2008 and December 2009,|5 patients signed consent, but were deemed screen failures and did not begin study treatment
750529|NCT00628901|Participants undergoing Uterine Fibroid Embolization for symptomatic uterine fibroids at the participating site, that met the study inclusion criteria, were approached for consent for inclusion into the study. Enrollment occurred from February 2006 to December 2009.|
750530|NCT00628862|Outpatients, male or female aged ≥ 40 years with moderate to severe chronic obstructive pulmonary disease (COPD). 766 subjects enrolled; 153 excluded: 96 for incorrect enrollment, 17 for adverse events, 32 for voluntary discontinuation, 1 for non-compliance with protocol, 7 for other reasons. 613 were randomised.|
750531|NCT00628758|FSI: LSI: LSO: Center type: Research and Training Host, Chest Medicine and Internal Medicine 23 Clinics. Number of enrolled subjects: 432, randomized: 430, completed patients: 344 ( Arm A:165, Arm B 179)|
750532|NCT00628628|Recruitment Period: January 28, 2008 to March 8, 2010. All participants were recruited in a medical clinic setting at The UT MD Anderson Cancer Center.|Eighty-two patients were enrolled between February 2008 and February 2010. Two patients withdrew consent and 80 patients were randomized; 40 to the Arm A and 40 to the Arm B.
750533|NCT00628589|The study was conducted at 24 centers - all in the US. Patients recruited for screening were admitted to a hospital or research unit with acute agitation, and were being treated for chronic underlying schizophrenia.|During the Pre-treatment Period, agitated schizophrenic patients were screened for inclusion in the study. This period lasted until the evaluations were begun.
750534|NCT00628498||
750535|NCT00628446|Recruitment began in 2007 and was completed in 2008. All recruitment was done at the Carolinas Rehabilitation Outpatient SCI clinic|
750536|NCT00628407|Potential subjects were screened from January 1, 2007-June 2, 2008 using the protocol inclusion and exclusion criteria. Any patient in the PICU (7 South or 7 East), Progressive Care Unit (PCU) and Operating Room (OR) settings involving stable but critically ill, mechanically ventilated children from 6 months to < 8 years of age.|
750537|NCT00628394||Some participants were never randomized due to Screening labs, illicit substances (repeatedly - exclusion), transportation issues, or simply being lost to follow-up. Lost to f/u were contacted 3 times and sent a letter in order to bring them back into the study.
750538|NCT00628355|All subjects were recruited at Center of Chronic Pelvic Pain at Hospital das Clinicas of Ribeirão Preto Medical School, during 2010. The study was early stopped because the comparator (lidocaine injection) appears significantly more effective.|
750539|NCT00628251|First patient enrolled on 30 July 2008 and last patient on 3 March 2009 at 25 centres in 9 countries|97 of 125 screened women with advanced BRCA 1/2 ovarian cancer who had chemotherapy were randomized
750540|NCT00628212||
750541|NCT00628147||
750542|NCT00628134|Eight subjects with cystic fibrosis were recruited.|Subjects performed two imaging study days. On one study day subjects inhaled Tc-SC particles suspended in calfactant. On the other study day they inhaled the same particles in saline. The order of the study days was randomized.
750543|NCT00628108||One subject was randomized to levocetirizine but received placebo; hence the number of subjects in both treatment groups in the Safety Population differs by 1 from the number of the subjects randomized (STARTED) to the respective treatment group. All results are presented for the safety population for which the subjects were analyzed as treated.
750544|NCT00628030||
750545|NCT00627978||
750546|NCT00627926||A total of 1095 subjects were enrolled, of which 7 subjects discontinued the study prior to study drug administration. A total of 1088 subjects started treatment.
750547|NCT00627861||
750548|NCT00627705|Recruitment started in March 2009 and ended in September 2010. This study was conducted in the Autism & Developmental Disabilities Clinic in the Division of Child & Adolescent Psychiatry, Lucile Packard Children's Hospital at Stanford University.|Fifty-one potential subjects inquired about the study. Forty-three of the subjects signed a consent form. Seven subjects were excluded because they did not meet criteria for autistic disorder. Three subjects decided not to participate in the study before baseline measures were obtained. Thirty-three subjects were randomized in the study.
750549|NCT00627679||"All subjects received all 4 treatments in a randomly assigned order. The treatments were:
~Treatment A: Pulmicort Respules® Treatment B: MAP0010 low dose Treatment C: MAP0010 intermediate dose Treatment D: MAP0010 high dose The sequences were Treatments ABDC, BACD, CDBA, DACB."
750550|NCT00627523|This randomized controlled trial enrolled small for gestational age (SGA) children at 16 centers in 8 countries. In total, 52 participants were screened for the study, of these, 9 participants were considered screen failures. The remaining 43 participants were randomized to receive either study drug (Genotropin®) or were not treated (Control).|Participants aged between 19 to 29 months at Screening visit, born SGA (birth length and/or weight <-2 standard deviations (SD) for gestational age, using country-specific standards), height below -2.5 SD at Screening (19-29 months of age), and had at least one measurement of length between 12 and 18 months of age were enrolled in this study.
750551|NCT00627497||
750552|NCT00627458||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
750553|NCT00627445|15 sites in China|Eligible subjects were subjects with type 2 diabetes having an HbA1c (Glycosylated Haemoglobin A1c) between 7.5-12.0 %, and treated with premix human insulin twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months qualifying for an intensified insulin treatment.
750554|NCT00627406|Recruitment period from jan. 2009 to dec. 2011. Participanting Clinics Fertility clinic Regional Hospital Skive, University Hostipal Odense, Regional Hospital Holbaek, Denmark.|
750555|NCT00627393||
750556|NCT00627367||
750557|NCT00627094||
750558|NCT00627042||
750559|NCT00627016|Subjects were enrolled at 33 investigative sites in the United States from 07 March 2008 to 20 March 2009.|Subjects eligible for entry into the Treatment Period were randomized into one of two, once-daily (QD) treatment groups.
750560|NCT00626925|The study was initiated at the University of Connecticut Health Center in March 2008 and was transferred to the University of Pennsylvania in December 2010. The last study visit was completed on 11/20/2013. We enrolled a total of 200 subjects, randomizing 138 to study medication. We recruited participants using flyers, newspaper and radio ads.|
750561|NCT00626912||
750562|NCT00626821||
750563|NCT00626808|This was a retrospective descriptive cohort study of participants up to 59 months of age included in a large medical insurance claims database. Participants up to 59 months of age were screened for vaccination with FluMist or TIV as part of routine clinical practice.|
750564|NCT00626795||An open-label treatment consisting of one arm with 4 age groups of 16 participants treated with TD1414 cream three times daily was used in a stepwise inclusion, to detect major safety issues that could prevent the study from proceeding. The participants in the open-label phase were not included the efficacy analysis or in the randomized population
750565|NCT00626782||
750566|NCT00626743||
750567|NCT00626639|After recruitment of 5 participants, the study was closed to further enrollment due to administrative changes at the study center (ie, departure of principal investigator) and slow enrollment.|
750568|NCT00626626||
750569|NCT00626574||
750570|NCT00626561|Recruitment Period: February 18, 2008 to November 04, 2010. All recruitment done at University of Texas (UT) MD Anderson Cancer Center.|Study was terminated early due to low accrual. One participant enrolled of four withdrew before being treatment.
750571|NCT00626548|2577 patients with hormone-resistant prostate cancer patients and bone metastasis were recruited between 15th January 2008 and 3rd May 2011|1156 of the 2577 enrolled patients were not randomised to treatment groups as they failed screening
750572|NCT00626522|"The study was conducted in a total of 81 sites: 21 in Russia, 13 in Poland, 8 in India, 8 in Romania, 6 in Australia, 5 in Taiwan, 5 in the Czech Republic, 5 in New Zealand, 4 in Hungary, 3 in Malaysia and 3 in Slovakia
~The first patient was screened in February 2008 and the last patient visit was in November 2008"|"A total of 808 patients were screened and 566 were randomized into the study
~Among 242 patients who failed to be randomized, the main reason for screen failure was non-fulfillment of one or more study entry criteria (156 patients), followed by subject's personal request (32 patients)"
750573|NCT00626444||
750574|NCT00626431|The enrollment of subjects with Formulation A occurred sequentially before the enrollment of subjects with Formulation B.|Formulation A and Formulation B treatment groups were enrolled sequentially. All analyses and summaries were conducted separately for both treatment groups.
750575|NCT00626405||
750576|NCT00626392|Participants were enrolled at 47 study sites in the United States between February and April, 2008.|This study had a 1-week run-in (acetylsalicylic acid [ASA] 325 mg or ASA placebo [Pbo] once daily) prior to 4 weeks of niacin extended-release (NER) plus ASA/ASA Pbo coadministration. Ten of 277 randomized subjects discontinued before run-in due to withdrawal of consent (4), lost to follow-up (4), protocol violation (1), and other (1).
750577|NCT00626366||
750578|NCT00626340|Participants were recruited at an outpatient research facility located at Yale University in New Haven, CT.|
750579|NCT00626327|Participants were enrolled at 90 centers in the USA|All subjects enrolled were included in the trial.
750580|NCT00626275||
750581|NCT00626210||
750582|NCT00626197|Screening was done from Day -14 to Day -1.|
750583|NCT00626093||
750584|NCT00626028|Children scheduled for clinically indicated right heart catheterization were screened for enrollment at 16 centers in the United States, United Kingdom, France, Spain and Netherlands.|All 136 patients screened received all three study drugs in a crossover design, serving as their own controls. They were randomized 1:1 into two treatment sequences.
750585|NCT00625989||
750586|NCT00625872||
750587|NCT00625846||
750588|NCT00625820|Patients were recruited from nephrology clinics based on baseline estimated glomerular filtration rate (eGFR). Informed consent was obtained from each patient prior to the study based on institutional review board (IRB) approved guidelines.|Seventeen patients were recruited and all started the trial.
750589|NCT00625807||
750590|NCT00625742|Recruitment Period: February 18, 2008 to December 15, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.|Early termination of the study due to follow-up issues and low recruitment numbers.
750591|NCT00625729||
750592|NCT00625703||No data available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful. Enrollment reflects the anticipated enrollment and actual enrollment is unknown due to PI is no longer at the institution.
750593|NCT00625586|Patient recruitment was conducted by two cancer institutes between April and June 2008.|
750594|NCT00625443||After Protocol Amendment 4, this study implemented a flexible dose regimen and was considered to have an open-label, uncontrolled, single-arm design. Due to these limitations in study design, a single grouping method with 3 subgroups was implemented for reporting participant disposition.
750595|NCT00625404||
750596|NCT00625391|Recruitment period: March 2008 - December 2008. Location: community setting|There was no any significant events arranged.
750597|NCT00625365|Participants were recruited from hospitals and clinics in the USA between February 2008 and April 2009|There were no pre-assignment requirements for this study
750598|NCT00625183||
750599|NCT00625131||
750600|NCT00624923||340 subjects signed consent and were screened for eligibility.
750601|NCT00624832||
750602|NCT00624819|Primed groups included Synflorix vaccinated subjects in study 10PN-PD-DIT-007. The Unprimed Group, added only in Year 4,included subjects unprimed with any pneumococcal vaccine age-matched with primed groups. The study included 3 sub-studies (111345, 111346, 111347) corresponding to Year 1, 2 and 4 time points post Dose 1 in Study 10PN-PD-DIT-001.|At screening, subjects with previous participation in 10PN-PD-DIT-007 study were invited to join this study. Informed consent was obtained and signed from subjects' parents/guardians, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected.
750603|NCT00624806||
750604|NCT00624780||This study employed 3 treatments in Period 1 and 6 treatments in Period 2. Randomization occurred once, at the onset of Period 1.
750605|NCT00624650||
750945|NCT00609492||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
750606|NCT00624585|Patients with Int-2 or High risk MDS according to International Prognostic Scoring System (IPSS) score. All World Health Organization (WHO) subtypes of Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or Myelodysplastic / Myeloproliferative (MDS/MPD) were allowed.|Acute Myeloid Leukemia Multilineage Dysplasia (MDS/AML) with <30% blasts (RAEB-t) who either declined or were deemed unfit for induction chemotherapy were also eligible. Exclusion criteria were WBC >50,000 off hydroxyurea, another malignancy requiring radiation or chemotherapy within the past 3 years, or concurrent therapy for MDS or AML.
750607|NCT00624559||
750608|NCT00624520|Recruitment commenced October 2009, completed December 2011 Recruitment from Cardiology Clinics W S Middleton Veterans Hospital, Madison, and Zablocki VA Medical Center, Milwaukee|Some enrolled participants were excluded from the trial if determined to have severe mental illness after administration of an SCID-I questionnaire and/or interview by a clinical psychologist. Others were excluded as drop-outs due to travel issues, weather, family issues, and illness. 2 subjects died before group assignment.
750609|NCT00624468||
750610|NCT00624442|The recruitment period was from April 2007 to January 2009.|
750611|NCT00624416||
750612|NCT00624377|A total of 2,031 patients were enrolled between Jan-11-2008 to Mar-24-2010|
750613|NCT00624338||
750614|NCT00624286||
750615|NCT00624234|Recruitment period was 2006-2012 and was done via NF organizations and NF clinics, as well as the community recruitment.|Exclusions: Incomplete Data (n=31), NF without Reading Difficulty (n=11), Age (n=13; excluded CNT and RD age 15yr and over because no NF-RD over 14yr), Low IQ (n=2), Ineligible (n=12; did not fit criteria for either RD or CNT group), Prior to Intervention Change (n=26; enrolled prior to an NIH-approved change in study design regarding intervention)
750616|NCT00624221||
750617|NCT00624195||
750618|NCT00624065||
750619|NCT00624052||
750620|NCT00624013|Patients were screened for depression using Whooley's two questions tool at a county diabetes clinic.|
750621|NCT00623974|Recruitment Period: May 2, 2008 to April 13, 2009. All recruitment done at UT MD Anderson Cancer Center.|A total of 7 patients were consented and screened. None of the patients met study entry criteria and thus were not randomized to treatment. Due to slow accrual, the study was closed.
750622|NCT00623935||
750623|NCT00623831||
750624|NCT00623805||
750625|NCT00623779|The study population included male and female participants >18 years of age with chronic non-valvular Atrial Fibrillation. The participants were recruited during the time period from 22 October 2007 to 21 October 2008 at medical clinics in Europe.|For participants treated with Vitamin K Antagonists (VKA) at the time of enrollment, VKA treatment was to be adjusted (and stopped before randomisation) to ensure that INR was below 2.0 at randomisation. If this was not achieved the participant was discontinued from the study.
750626|NCT00623766||A total of 99 participants were enrolled, and 27 did not receive treatment because they did not meet screening criteria.
750627|NCT00623727|Previously treated participants with severe hemophilia A (<1% FVIII (Factor VIII)), who were currently on on-demand or secondary prophylaxis treatment with any FVIII for ≥150 exposure days (ED) with documented bleeds/injections during the last 6 months prior to study entry could participate in the study.|Of 168 enrolled participants, 25 failed screening.
750628|NCT00623714|"First Patient Entered: 28-Jan-2008
~Last Patient, Last Visit: 05-Mar-2009
~1 site"|"Inclusion
~Mild/moderate allergic asthma
~Allergic to house, dust, mite allergen
~Early and late allergic response to inhaled allergen challenge
~Randomized sequence of treatments including 500 μg fluticasone or placebo in treatment periods 1 & 2. Treatment was twice a day (b.i.d.) for total of 5 doses over 3-day period."
750629|NCT00623636||This study included a Double-blind period for 8 weeks followed by an open-label period that lasted an additional 52 weeks. All patients participating in the open-label period received MAP0004.
750630|NCT00623623|Open-label, prospective, randomised, parallel, comparative international multicentre trial|All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
750631|NCT00623597|A total of 18 participants were recruited from 8 centers in Argentina (3 centers), Spain (1 center) and Thailand (4 centers). This study was conducted between May 20, 2008 and March 11, 2010.|Participants were human immunodeficiency virus (HIV) infected infants and young children who met the eligibility criteria were stratified into 2 groups - low age (>= 4 months to <2 years) and high age group (>= 2 years to <6 years). Participants commenced treatment with saquinavir and ritonavir along with background antiretroviral (ARV) regimen.
750632|NCT00623545|Recruitment period was ca. 5/1/2008 to 6/30/2010. Subjects were recruited through local advertisements|Subjects were not entered if they failed to meet entry criteria or failed to attend informational appointment
750633|NCT00623506|Subjects were recruited from the Durham Medical Center, Durham, NC.|Each subject received a two week placebo-lead in following enrollment.
750634|NCT00623480||
750635|NCT00623467|The date of the first participant's first visit was 17 DEC 2007. The date of the last participant's last visit was 12 DEC 2008.|A total of 347 participants were screened for inclusion into the study; 4 participants failed screening because they did not meet the inclusion criteria. Therefore, 343 participants were enrolled into the study and received study drug.
750636|NCT00623441|Consecutive patients with an indication for coronary stent implantation according to the Instructions For Use of the Endeavor Coronary Stent, in whom it is an intent to implant one or more Endeavor Coronary Stents should be included (provided patient consent).|All enrolled subjects were followed for 12 months. An extended 2-year follow-up was performed in 2116 subjects from 26 centers.
750637|NCT00623428|Patients with Chronic Hepatitis C, Genotype 2 or 3 who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care during a pre-study run-in phase and did not achieve a rapid viral response defined as HCV RNA <15 IU/mL at Week 4 of treatment were eligible and entered the screening phase between treatment Weeks 4-8.|235 patients enrolled and continued with the dose regimens they were taking prior to enrolment up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (compared to HCV RNA prior to treatment initiation) or had HCV RNA <15 IU/mL and who were still taking study medication at Week 24, were randomized at Week 24.
750639|NCT00623194|29 sites in 11 countries: (Bulgaria (3 sites), Czech Republic (3 sites), Denmark (2 sites), Finland (4 sites), France (1 site), Hungary (2 sites), Macedonia (1 site), Poland (4 sites), Russian Federation (4 sites), Turkey (4 sites) and United Kingdom (1 site)|At entry subjects had finalised 52-weeks treatment with insulin detemir plus insulin aspart (Trial NN304-1689, NCT00435019). Subjects treated with NPH insulin plus insulin aspart in trial NN304-1689 were not offered to continue in this extension trial. Subjects continued treatment with insulin detemir and insulin aspart doses from trial NN304-1689.
750640|NCT00623181|Participants were enrolled and treated from 25 January 2008 to 11 March 2008 in 1 medical center in the US.|A total of 110 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
750641|NCT00623103||
750642|NCT00623012||
750643|NCT00622908|Study was started on 12/28/04 and last patient last visit was 6/7/05. This study took place at 35 centers in the US.|270 subjects were enrolled, 269 were randomized(1 subject refused culture), 118 of which had bacteriologically confirmed acute bacterial conjunctivitis at baseline.
750644|NCT00622895||
750645|NCT00622869||
750646|NCT00622739||
750647|NCT00622726|Dates of recruitment: March 13, 2008 to August 4, 2010. Patients recruited were all in neonatal intensive care units.|
750648|NCT00622713||
750649|NCT00622700|A total of 846 participants were screened, of which 618 randomized in core treatment period. Out of 618, 423 entered in extension treatment period. End date of core treatment period was 17 December 2012 (maximum treatment duration: 120 weeks). End date of extension treatment period was 05 February 2016 (maximum treatment duration: 283 weeks).|Participants were randomized in 1:1:1 ratio to teriflunomide 7 mg,14 mg or placebo in core treatment period. Those completing core period, given opportunity to enter long-term extension period (participants originally given placebo re-randomized [1:1]to teriflunomide 7 mg/14 mg; those originally given 7 mg,14 mg continued with the same fixed dose).
750650|NCT00622635||
750651|NCT00622544||
750652|NCT00622518|patients were recruited from 2/4/08 through 2/23/09 at a pediatric primary care clinic at the time of a visit for acute otitis media|
750653|NCT00622466||
750654|NCT00622440||
750655|NCT00622427|Subjects were screened by medical and psychiatric history after responding to solicitation with advertisements in local newspapers and from existing clinic populations.|
750656|NCT00622401||
750657|NCT00622388||
750658|NCT00622336|This was an international, open-label single arm study of oral lenalidomide in participants with multiple myeloma who had previously received high dose dexamethasone alone or in combination with thalidomide in the study NCT 00057564, or previously received high dose dexamethasone alone in studies NCT 00056160 and NCT 00424047.|To be eligible participants must have developed disease progression or were unable to tolerate the lowest dosing regimen of thalidomide and/or high-dose dexamethasone without Grade 3 or 4 toxicity
750659|NCT00622284|There were in total 1560 patients randomised in the study. Of these, 1 patient was not treated. The remaining 8 patients not accounted for in the treated set were removed from all study analyses (explained in trial report) due to major good-clinical-practice violations at the site, and the inability to verify the validity of any patient level data.|
750660|NCT00622180||It was our hope to enroll 26 Participants but only 13 was enrolled.
750661|NCT00622167|Subjects were enrolled from January 2008 until September 2008. The study ended early due to slow enrollment.|Subjects were consented prior to cardiac catheterization, and if they did not meet angiographic inclusion criteria they were withdrawn from the study.
750662|NCT00621985|Subjects were recruited from the Endocrine Clinic at Children's Hospital Boston from April through November 2008.|This was a cross over study. All subjects were admitted on their baseline hydrocortisone regimen for a 24 hour hospital admission. They then had a second hospital admission within 8 weeks while being administered the dexamethasone therapy.
750663|NCT00621959||
750664|NCT00621946||
750665|NCT00621933||This was a culture swab study at a single time-point. No medications were administered and patients were not followed beyond the initial culture.
750666|NCT00621855|International multi-centre trial with 161 trial sites in 24 countries recruiting patients with acute coronary syndromes with increased troponin levels within 14 days post index myocardial infarction (ST or non-ST elevation between March 2008 and March 2009.|Patients receiving aspirin and clopidogrel at randomisation were included. They also had at least 1 additional risk factor (for e.g. age ≥65 years, diabetes previous myocardial infarction, peripheral arterial disease). Moderate renal impairment at screening resulted in dose adjustment.
750667|NCT00621842|Recruitment began in January 2008 and ended in December 2009. The study screened and enrolled participants at five academic institutions in the United States.|All subjects were required to have a score of 18 or higher on the Hamilton Rating Scale for Depression 24 to be included in the study.
750668|NCT00621777|Enrolled from 03/08 to 04/12 from 10 community mental health centers in MA, MI, NH, IN, AL, and MN, participants were 18-70 years, outpatients with schizophrenia, schizoaffective or bipolar disorder, smoked 10+ cigs/day, had CO levels >9 ppm, willing to take varenicline, agreed to set a quit date within 4 wks of enrollment, and were stable|44 participants were excluded after signing consent: 4 site closure, 40 Did not meet inclusion criteria, 17 Active substance abuse, 8 Unstable medical condition, 8 Unstable psychological symptoms, 4 Lost to follow-up, 3 Other
750669|NCT00621764|The study participants were enrolled from 02 March 2008 to 06 January 2009 at 3 clinic centers in Thailand.|A total of 300 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
750670|NCT00621686||
750671|NCT00621621||
750672|NCT00621582|"There is a gap between the enrollment number (4922) and the started patients (treatment number, 4812), as some of the enrolled patients did not accept the treatment.
~the number of started patients was 4918, among which 106 patients prematurely discontinued"|
750673|NCT00621543||
750674|NCT00621530||
750675|NCT00621517||
750676|NCT00621504|The enrollment period was from 02 January 2008 to 29 December 2008|Patients were screened for up to 24 hours
751434|NCT00587041|Subjects were recruited from Mayo Clinic, Rochester, Minnesota between Mayo 2006 and May 2009.|
751435|NCT00586924||
750677|NCT00621348|Enrollment: September 2006 to April 2008 Analysis: May and June 2008 Pediatric ward and Pediatric intensive care unit in a tertiary care referral hospital in North India|Patients were stratified based on their age in to three groups (age 3 months to 1 year, 1-5 years, 6-12 years) and stratified randomization was used.
750678|NCT00621322||
750679|NCT00621309||29 participants signed consent form. 23 participants had full measures for data analysis.
750680|NCT00621296||
750681|NCT00621257||
750682|NCT00621244||
750683|NCT00621192|Enrollment Period - June 19, 2008 to October 6, 2009 Locations - Hospitals including University Hospitals Total number of sites - 24 Total number of participants - 200|Other antimicrobials in addition to meropenem was used in the study due to concerns regarding the safety and ethics of using monotherapy in this patient population.The study was designed as an open-label, dose escalation study because sufficient data regarding the feasibility of a randomized, active controlled efficacy study was unavailable.
750684|NCT00621179||
750685|NCT00621153|253 enrolled, 20 screening failure, 223 randomised, 198 completed|
750686|NCT00621140||
750687|NCT00621049||
750688|NCT00621023|Recruitment period occurred from November 2007 to April 2010 at Duke University Medical Center.|1 patient was consented and found to be ineligible, and did not participate in the study.
750689|NCT00620945|Dates of Recruitment: June 2006 to September 2008|
750690|NCT00620854|Subjects were recruited from the study site data base during January 2008.|
750691|NCT00620828|12 of the 79 subjects enrolled were screening failures, thus total number of subjects completing the study = 67. One patient had staged bilateral TKA so there are 66 total patients, but 67 injections given.|12 of the 79 subjects enrolled were screening failures
750692|NCT00620815|Participants were enrolled at 2 sites in Germany|All subjects were included in the trial. The data entered is for the overall study.
750693|NCT00620776|Three hundred thirty four patients enrolled in the first phase (6-month open-label) of a parent medication trial for GAD (NCT00183274) were recruited and seen in one of four primary care practices or a psychopharmacology clinic in a university setting from 2005 to 2009. The current study was conducted from October, 2006 to March, 2008.|Of 334 patients who consented to the parent trial, 66 did not receive study drug (64 withdrew consent and 2 were protocol violators), leaving 268 who received at least one dose of open-label venlafaxine XR. For this study, 77 patients were randomly assigned to be offered CBT and 40 patients to not be offered CBT.
750694|NCT00620763|Participants were recruited from the Grand Forks, North Dakota community in November and December, 2007.|Of the 128 women who applied for the study, 56 did not meet the criteria, 46 declined, 4 were alternates, and 22 joined the study.
750695|NCT00620750|The study began July 2007. Community recruitment was performed from August 2007 to September 2008 in the primary care clinics of Bellevue Hospital and Gouverneur Diagnostic and Treatment Centers, two public hospital facilities in lower Manhattan. 116 persons contacted study staff regarding possible participation, and 76 were consented and screened.|Four consented patients were ineligible due to elevated liver function tests (n = 2), opioid dependence (n =1), and an uncontrolled psychiatric condition (n = 1). Seventy two participants met eligibility criteria and consented to study involvement, sixty-five participants presented for the initial treatment visit.
750696|NCT00620711|Preterm Infants meeting criteria for HIE 6 hours old|
750697|NCT00620698||
750698|NCT00620659|The majority of patients were recruited from investigators' own databases at 24 sites in the United States. The primary therapy period was 13-Mar-2008 to 25-Feb-2009.|Participants maintained sleep and sleepiness diaries during a 7- to 10-day placebo run-in period. They used a nasal continuous positive airway pressure (nCPAP) device to monitor their CPAP use. At the end of the run-in period, participants stayed overnight at the clinic for nighttime polysomnography and if eligible, were randomized the next morning
750699|NCT00620555||
750700|NCT00620542|2333 Coronary Artery Disease (CAD) patients with clinical indication for coronary angiography were randomized to Part A, the 2-week run-in period. Of these, 1578 patients were treated and 1385 completed Part A. The 1385 patients completing Part A were then randomized to Part B the core study period of 104 weeks of treatment.|Angiography was performed to determine if patients were qualified to continue in the study based on protocol-specified angiographic criteria. Patients who satisfied all inclusion and exclusion criteria had an Intravascular Ultrasound (IVUS) performed within 2 weeks of the qualifying angiography.
750701|NCT00620503||
750702|NCT00620464||
750703|NCT00620425||
750704|NCT00620373|Subjects were enrolled between September 2005 and February 2009 in Rochester, Minnesota.|969 subjects completed imaging and met eligibility criteria, but 33 were excluded because of lack of the reference standard (unverified cancer status).
750705|NCT00620321||The reasons for discontinuation listed in the Participant Flow are the reasons the participant discontinued treatment. All participants who have completed at least 1 cycle of study drug were considered to have completed the study.
750706|NCT00620282|The trial was conducted at one site in the United States of America (USA).|
750707|NCT00620191|Recruitment was completed in 32 months (2.5 subjects a month) [38]; 1426 subjects were screened by telephone and 331 were screened in person.|1426 screened by telephone and 1095 excluded; 331 deemed eligible for in-person screen; 224 of those were excluded; 87 met eligibility criteria, 7 declined randomization, 80 were randomized
750708|NCT00620126||
750709|NCT00620113||Of 403 participants screened, 287 participants were randomized to treatment on study. 286 participants received the correct treatment on study and were used for safety and efficacy analyses. One participant in the odanacatib 25 mg group also received 50 mg odanacatib during study by mistake and was excluded from all analyses.
750710|NCT00620074||Study was closed due to an overall low rate of enrollment after only 6 subjects enrolled.
750711|NCT00620061|Participants were enrolled from 4 December 2007 to 29 September 2009 at 137 recruitment sites in the United States (n=134) and Canada (n=3)|
750712|NCT00620035||At screening, a participant number was allocated to 308 participants of which 7 participants did not receive treatment. A total of 301 participants had an implant inserted.
750713|NCT00620022||
750714|NCT00619983||
750715|NCT00619970||
750716|NCT00619957|Recruitment began on 03 Jun 2002.|
750717|NCT00619918|Subjects were recruited beginning March 2008 and April 2011, only during months of bronchiolitis season (November through April). Recruitment occurred in the emergency department and general medical inpatient units at 2 urban tertiary free-standing children's hospitals in the U.S.|No patients were excluded after enrollment but before randomization.
750718|NCT00619892||
750719|NCT00619866|The study was conducted at 50 centers in the United States from February 2008 to August 2009.|Patients were randomized equally to oral elagolix 150 mg or 250 mg once daily, or placebo for 12 weeks. Thereafter, patients originally randomized to placebo were re-randomized to one of the two elagolix doses and patients originally randomized to elagolix continued their assigned dose for an additional 12 weeks.
750720|NCT00619827|First Patient First Visit 17 SEP 2007, Last Patient Last Visit 10 MAR 2008|
750721|NCT00619801||
750722|NCT00619762|17 women were identified & consented to participate in the study. All were enrolled and received study product. Of the 17 women, 5 underwent unilateral reconstruction and 12 underwent bilateral reconstruction for a total of 29 breasts evaluated in the study. Patients were recruited from Hospital settings in PA, IL, Washington DC, NY, and VA.|This study was a prospective, multicenter, open-label study with no control arm. All enrolled women/breasts remained in the study through expander/implant exchange up through the Month 3 post-exchange visit.
750723|NCT00619723||
750724|NCT00619684||
750725|NCT00619645||
750726|NCT00619619|Treatment to be given at only 1 dose level at a time for at least the first 6 subjects per dose group. Approximately 6 to 8 subjects were to be enrolled in each of the dose cohorts; 4 dose levels were to be evaluated per age stratum in sequential manner and ascending order (10 to 100 milligrams (mg) for children; 25 to 200 mg for adolescents).|Screening period 6 to 14 days followed by treatment period (up to 3.5 day inpatient and up to 7.5 week outpatient phase). Participants who enter outpatient period but do not continue into 6-month open-label extension study (NCT00669110) will participate in taper period of 0 to 2 weeks depending on dose of study treatment to which they are assigned.
750727|NCT00619515||
750728|NCT00619502|Participants were enrolled from 14 December 2007 to 07 January 2008 at 1 clinical center in Turkey.|A total of 254 participants who met all inclusion, but no exclusion criteria were enrolled and vaccinated.
750729|NCT00619489|Participants took part in the study at 14 investigative sites in Canada and Russia, between 07 December 2007 and 31 March 2010.|Treatment-naïve ulcerative colitis (UC) or Crohn's Disease (CD) participants were assigned to receive 6.0 mg/kg vedolizumab. Participants who rolled over from Study C13002 (NCT01177228) were assigned to receive 2.0 mg/kg vedolizumab.
750730|NCT00619476||
750731|NCT00619385||
750732|NCT00619359|Patients were recruited from 149 medical centers worldwide. The recruitment period was from 12 Feb 08 through 8 Jun 09.|Cisplatin-naïve patients scheduled to receive cisplatin chemotherapy at a dose of 70 mg/m2 or higher for a documented solid malignancy were screened up to 30 days prior to initiation of chemotherapy. Screening included a complete medical history and physical exam. Informed consent was obtained for patients who agreed to participate in the study.
750733|NCT00619307|Subjects were enrolled from 16 July 2007 and attended the last visit on 11 April 2008. One hundred and twenty three subjects gave informed consent and 117 were enrolled. Of these, all were treated except one subject scheduled to receive prophylactic ibuprofen, who withdrew consent before treatment.|There were 17 active centres, 6 centres in France and 11 centres in Germany. Screening visit took place within 2 weeks of randomisation. Six subjects were screening failures.
750734|NCT00619255||
750735|NCT00619242|The study was activated and opened to accrual 06/19/2006. the study was terminated 7/17/2009. Subjects were seen in the University of Chicago outpatient clinics.|Subjects must have histologically confirmed Barrett's esophagus with high-grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS) on prior endoscopy within the previous 12 months.
750736|NCT00619229|"The Full Analysis Set (FAS) includes all randomized subjects treated with at least one infusion and having valid Baseline and Post-Baseline measurements.
~The Randomized Set (RS) consists of all randomized subjects who have completed Visit 16 or terminated prematurely."|Participant Flow shows the RS. Baseline Characteristics refer to the FAS.
750737|NCT00619190||
750738|NCT00619177||"Number of patients:
~treated set = 3569 (treated with Movalis)
~full analysis set = 3473 (patients completed 2 visits and had baseline and final 12-item Short-Form Health Survey (SF12) score)"
750739|NCT00619151||
750740|NCT00619112|Patients recruited from within established neuro oncology clinic at UCSF. First paient 11.5.2007 and last patient 1.24.2012|
750741|NCT00619099|This study was recruited at 5 centers in U.S. during the period of Jun 2008 to Aug 2011.|
750742|NCT00619073|Participants recruited at UMass Medical School in Worcester, MA between April 2008 and May 2009.|15 healthy participants recruited; 16 screened, 1 excluded (1 did not meet inclusion criteria).
750743|NCT00619060||
750744|NCT00618995|"Phase I
~First Patient Enrolled 21 Aug 2007, First Patient Treated 7 Sept 2007.
~Study conducted at 3 centers: Arkansas Research Medical Testing, LLC, Little Rock, AR; Healthcare Discoveries Inc., San Antonio, TX; and Comprehensive Phase One, Fort Myers, FL. Merck's ER Niacin was used."|Subjects were treated either w/diet and exercise alone, or with metformin, or a sulfonylurea, and had to be on stable meds for >= 8 wks pre-study.
750745|NCT00618982|Subjects were enrolled from 04 Feb to 05 Nov 2008 at 19 centers in 5 countries (Germany, France, United Kingdom, Italy and Poland).|Of the 89 subjects enrolled, 83 were treated with the study drug. Safety population = 83 subjects who took at least one dose of study drug and had any data after baseline. Intent to treat population = 67 subjects treated with the study drug who had at least one efficacy evaluation after baseline.
750746|NCT00618956|Recruitment period was from October 15, 2007 to April 16, 2008 at 38 centers in the US.|Following 1-to-4 week washout/single-blind placebo lead-in period, patients were randomized (2:1) to one of the treatment groups, milnacipran or placebo, respectively; and orally treated with study medication for 7-week, double-blind treatment period (Visit 2 to 6), followed by a 2-week single-blind placebo discontinuation period (Visit 6 to 8).
750985|NCT00607672|Adult patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass were recruited from the Vanderbilt surgery clinic between 2006 and 2011.|Patients were excluded after enrollment if they met exclusion criteria, if surgery was canceled or if the patient changed his mind.
750986|NCT00607620||
750747|NCT00618839|The study evaluated autograft take and infection in 15 patients with full-thickness skin defects who required sequential surgical procedures. Subjects had surgical excision and temporary placement of StrataGraft and cadaver allograft. The trial was conducted at the University of Wisconsin Hospital and the Arizona Burn Center.|All subjects were treated with both StrataGraft and cadaver allograft in a split-wound design. The half-wound sites were randomized to receive StrataGraft or cadaver allograft.
750748|NCT00618826||
750749|NCT00618813||
750750|NCT00618787|The first study subject was randomized on March 5, 2008 and the last subject visit was conducted on February 18, 2009. Subjects were screened for eligibility, consented, enrolled and randomized at two participating wound care clinics.|
750751|NCT00618774||
750752|NCT00618748||
750753|NCT00618722|The study was conducted at 6 study centers: 1 in the United Kingdom, 2 in Canada, and 3 in Australia.|Enrollment was conducted in 2 stages, an initial cohort in which preliminary safety and tolerability were evaluated and a second cohort (contingent cohort), which was enrolled after it had been determined that acceptable safety and tolerability were observed in the initial cohort. Participants from both cohorts were pooled for analysis.
750754|NCT00618618|This study was conducted at 7 study centers: 4 in Canada, 2 in Australia and 1 in the United Kingdom.|Participants were randomized to receive either deoxycholic acid or placebo injection in one of 3 treatment dosing regimens for a total of 6 treatment groups. Placebo participants were pooled for analysis.
750755|NCT00618540||
750756|NCT00618514|Subjects who had a planned endovenous laser ablation treatment for varicose veins that included treatment of the Greater Saphenous Vein (GSV) were recruited from medical clinics.|93 subjects enrolled, 3 subjects were not randomized because they withdrew consent prior to receiving study procedure; 90 subjects randomized and 110 limbs were assigned treatment.
750757|NCT00618449|Recruitment period Jan-08 thru May-09 in ten villages within the Maradi Region of Niger with high prevalence of clinically active trachoma amongst children<= age 10.|
750758|NCT00618436||
750759|NCT00618410||
750760|NCT00618371|The study was approved in 10/2007. HIV-infected individuals 18 years of age receiving stable, suppressive antiretroviral therapy (ART) with persistent plasma HIV-1 RNA level of > 0.6 copies/mL by single-copy assay at screening; enrollment started in in 12/2007 at the University of Pittsburgh Clinical Trials Unit from 12/2007 through 1/2009.|Participants had Cluster of Differentiation 4(CD4) counts of greater than 200 cells/microliter, HIVRNA< 50 copies/mL plasma for ≥12 months; and not receiving prophylaxis for opportunistic infections (OI)s; no history of exposure to raltegravir, HIV-1 drug resistance,febrile illness within 3 weeks or vaccination within 6 weeks before enrollment.
750761|NCT00618332||
750762|NCT00618072|Patients were enrolled from December 2007 until November 2010. The study was conducted at two academic medical centers: Montefiore Hospital/Einstein, Bronx, and Westchester Medical Center/New York Medical College, Valhalla, NY in conjunction with the GCRC at Einstein.|Prior to randomization, subjects attended 4 weekly workshops to introduce study instruments & the EMPOWIR diet -a food exchange program promoting intake of vegetables, low-glycemic index fruits, low-fat protein & dairy products, elimination of added sugars & the notable restriction of 3 additional allowable carbohydrates to after 4PM.
750763|NCT00617981||
750764|NCT00617942||
750765|NCT00617929||
750766|NCT00617903||
750767|NCT00617890||
750768|NCT00617851|Participants were recruited at 1 Center along with a satellite center in the Dominican Republic.|
750769|NCT00617773|This was a brazilian, multicentric clinical trial. From June 20, 2008 to July 13, 2010 (recruitment period of 24 months) a total of 51 patients were screened for this study, of whom 31 were considered eligible and received at least one dose of the investigational product and 20 were considered non-eligible.|Patients were considered included in the study on the day of the first investigational product administration after investigator assured that patients met all the inclusion criterions and none of the exclusion criterions.
750770|NCT00617734||Presented are the reasons the participants discontinued from the study treatment.
750771|NCT00617708||
750772|NCT00617669|1494 patients with hormone resistant prostate cancer patients and bone metastasis were recruited between 24th January 2008 and 10th May 2011|442 of the 1494 enrolled patients were not randomised to treatment groups as they failed screening.
750773|NCT00617604|Of 221 patients screened, 218 patients were enrolled into the study at 30 centers across 12 countries.|
750774|NCT00617591|57 Eligible participants were enrolled at Moffitt Cancer Center between February 2008 and February 2011.|
750775|NCT00617539||
750776|NCT00617461||Participants (par.) were enrolled in a two-week Baseline Period, which included treatment with 1800 milligrams (mg)/day gabapentin. Participants who met entry criteria were then randomized. Inv., investigator.
750777|NCT00617409||
750778|NCT00617396|Subjects were recruited from UNC GI outpatient clinic. Other recruitment strategies like newspaper ads, UNC mass emails and flyers were used. Recruitment started around 12/2007.|This was 13 week long study which included 1 week of screning period followed by 4 weeks of treatment phase and 4 weeks of follow up period. During the screening visit following procedures were done- informed consent,medical history and demographics collection Vitals including abdominal girth,physical examination baseline labs and questionnaires
750779|NCT00617357|83 subjects enrolled between Sep 2007 and Aug 2008 from 12 US sites and followed for 24 months following hernia repair|83 subjects were enrolled, 3 were not implanted, resulting in 80 subjects implanted with device (ITT group).
750780|NCT00617344|Study participants were enrolled from 17 April 2008 to 04 June 2008 at 5 sites in the United States.|A total of 309 participants were screened in the study, out of which 260 participants were enrolled and vaccinated in the study. Screen failures were mainly due to inclusion criteria not met or exclusion criteria met.
750781|NCT00617305|Patients were enrolled in 16 study sites in the US. The first patient was screened on 09 April 2008, and the last patient was enrolled on 28 July 2010. The last patient observation was on 25 July 2011. Originally a double-blind, placebo-controlled study, it was changed to open label on 12 June 2009 due to slow enrollment.|65 patients were screened; 8 were randomized (3 to ambrisentan and 5 to placebo) prior to study conversion to open label. The remaining patients were assigned to ambrisentan treatment.
750987|NCT00607594||
750782|NCT00617279|Patients requiring below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease were recruited. Recruitment commenced December 2007 and was terminated by the Sponsor January 2010 due to slow enrollment. Investigative site locations included university hospitals and other medical clinics.|
750783|NCT00617240|The first subject was enrolled into the study in January 2007 and enrollment ended in June 2009. All participants came to the ASPIRE clinic for all study visits.|The study sought to recruit participants who had minimal or no prior exposure to second generation antipsychotics and no previous treatment with metformin.
750784|NCT00617201|Adult volunteers ages 18-60 reporting cocaine use in the preceding 30 days who met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) criteria for and were seeking treatment for cocaine dependence were recruited through advertisements and word-of-mouth to a research clinic.|Exclusions included dependence on any drug requiring detoxification, other Axis I disorders, medical problems, pregnant or lactating females, Cytochrome P450 2D6 inhibitors/inducers, monoamine oxidase inhibitors or selective serotonin reuptake inhibitors. Enrollment in other drug treatment programs urine samples required for parole/probation.
750785|NCT00617188||3 additional patients were enrolled, but were never treated.
750786|NCT00617175||
750787|NCT00617123|Participants were recruited from participants enrolled in Study SCH 530348 P04737 (NCT00526474) and met the inclusion/exclusion criteria for this study.|A total of 258 particpants were referred to opthalmology sites, 65 of whom did not particpate in this study (P05138) beyond the screening visit and were not included in the analysis of ocular safety. A total of 193 participants were included in the analysis of ocular safety.
750788|NCT00617097||
750789|NCT00617084|"Start recruitment: April 30, 2008 > End recruitment: October 28, 2008
~> Types of location: medical clinic"|
750790|NCT00617058|Potential subjects will be identified through referrals that the research program receives for other clinical trials involving the same age population with similar diagnoses. We also plan to access PHI to identify potential subjects and use MIM and the ISD helpdesk to complete hospital review of individuals ages 10-17 taking an antipsychotic.|Randomization will be completed using computer generated randomization schedules. In order to preserve adequate sample sizes in the cells, important variables such as pubertal status, concomitant valproic acid, concomitant stimulants, gender, race (Asian/Caucasian vs. Other), and ethnicity (Hispanic/Non-Hispanic) will be examined as covariates.
750791|NCT00616967||
750792|NCT00616941||
750793|NCT00616928||
750794|NCT00616902|A total of 220 participants were to be randomized in a 1:1 ratio to each treatment group to receive paricalcitol injection or placebo at 75 US and ex-US sites. A stratified randomization scheme was used to ensure balance among treatment groups with respect to country, sex, and baseline Renin Angiotensin-Aldosterone System (RAAS) inhibitor use.|The Screening Period consisted of 3 visits and occurred within 6 weeks prior to participant randomization and enrollment into the Treatment Period of the study. For enrollment, all screening labs and echocardiogram requirements had to be met. Also, a technically adequate cardiac MRI had to be obtained for participant to be randomized into study.
750795|NCT00616772||
750796|NCT00616759||
750797|NCT00616655||
750798|NCT00616642|2006 - May 2009|
750799|NCT00616629|A total of 68 patients were enrolled into the study. The study randomised 55 patients and 50 of those patients received study drug. All patients who received study drug completed the study.|At the pre-entry visit, which took place within 14 days before the planned catheter ablation (Study Day), patients underwent a full clinical assessment including a physical examination, ECG recording, Bood pressure(BP)/heart rate measurement, routine laboratory tests, and transthoracic echocardiography (TTE, if not done within the prior 6 months).
750800|NCT00616603|The recruitment process began on 10/4/2007. The last subject to be recruited was on 02/23/2009. Subjects were consented at their Pre-anesthesia appointment or in the Observation Unit prior to their surgery.Some subjects were pre-consented by a resident on the phone prior to their surgery date.|We had 4 subjects withdraw because of screen failure, rescheduled surgery and physcian withdrawal.
750801|NCT00616577||IRB annual renewal indicates 26 participants Resident on the project indicates only 22 started the study.
750802|NCT00616434||
750803|NCT00616421|Participants were enrolled at 67 centers in the USA and Canada.|All subjects enrolled were included in the trial.
750804|NCT00616343||
750805|NCT00616239||
750806|NCT00616200|All patients responded to advertising in local media for participation in a research study looking at IBS-D. Patients presented to the General Clinical Research Center at the University of North Carolina. Each of the six weekly study visits and one baseline visit was conducted at the UNC GCRC.|
750807|NCT00616122||Phase I patients received escalating doses of sunitinib in a 3x3 design. None of the patients in the phase I study was included in phase II. Phase I patients receiving treatment at the phase II dose were included in the overall efficacy analysis of the phase II study but were not counted toward the enrollment accrual of the phase II study.
750808|NCT00616109|16 subjects recruited from 7/19/2007 to 2/1/2010 at University of Michigan, Ann Arbor(lead site), and sub-sites: The University of Detroit's Karmanos Cancer Institute, WSU, Detroit; Weill Cornell Medical College, NY; and Roswell Park Cancer Institute, NJ|Patients with histologically or cytologically documented Extensive-Stage Small Cell Lung Cancer (ES-SCLC) who had received no more than 4 cycles of frontline platinum plus etoposide chemotherapy and who demonstrated a response or stable disease were eligible. ES-SCLC was defined as disease extending beyond 1 hemothorax and regional lymph nodes.
750809|NCT00616018|Study was conducted from August 2007 through January 2008. Healthy volunteers were recruited through flyers posted in community settings.|Thirty-five subjects were consented for the study. Of these, eight were excluded (six did not meet inclusion criteria and two refused to participate). The 27 eligible subjects were assigned to the treatment arm to receive 4 grams of acetaminophen per day, for 10 consecutive days.
750810|NCT00615992||
750811|NCT00615927||
750812|NCT00615914||
750813|NCT00615901||
750988|NCT00607477||
750989|NCT00607386||
751436|NCT00586898||
751437|NCT00586846||
751438|NCT00586820||
751439|NCT00586729||
750814|NCT00615836|The study was open only to participants who were enrolled in Study FE992026 CS29 (NCT00477490) and had completed at least Visit 3E in Part II (Day 15) of that study. 799 patients were randomized to treatment in CS29, and 601 patients formed the intent-to-treat population in CS29. This population was used to assess durability of effect in CS31.|Participants were initially assigned in a blinded manner to the same treatment dose received in Study CS29. After CS29 database lock, CS31 was unblinded, and based on the results of CS29, participants assigned to 10 μg were randomly assigned at their next scheduled visit to 25 μg, 50 μg, or 100 μg of desmopressin Melt.
750815|NCT00615784||
750816|NCT00615719||
750817|NCT00615589||
750818|NCT00615550|March 2008 to June 2010|
750819|NCT00615472|We enrolled only a few patients. Our neurocognitive battery was too hard for patients to get through. Therefore, the study was stopped.|
750820|NCT00615459|Patients were randomized to one of the 4 possible treatment sequences of the double-blind 10-week treatment phase (Week 1 - 10) to receive three out of the four study treatments. Each treatment sequence was divided into three 2-week treatment periods (I/II/III), with periods I and II followed by 2-week washout periods.|Out of total 169 randomized patients, two patients were discontinued before exposure to any treatment in period I because of administrative problems.
750821|NCT00615433||
750822|NCT00615420||
750823|NCT00615290||
750824|NCT00615264||
750825|NCT00615199||
750826|NCT00615108||
750827|NCT00615069|Recruitment: May 2006 - Mar 2009 (Study Subjects and Continued Access)|
750828|NCT00615056||
750829|NCT00615030|Patients were randomized to one of the 12 possible treatment sequences of the double-blind 10-week treatment phase (Week 1 - 10). Each treatment sequence was divided into three treatment periods (I/II/III) of 15-day duration each. The first and second treatment period of each sequence was followed by a 2-week washout period.|Total 96 patients were randomized; one randomized patient discontinued from the study prior to exposure to study drug because of abnormal test procedure(s) result.
750830|NCT00615017|The first patient was enrolled on January 18, 2008 and the last patient had their last visit on July 30, 2009. Patients were randomised at 17 centres in the United States of America|70 adult patients with severe sepsis, clinical evidence of infection requiring parenteral antibiotics, meeting systemic inflammatory response syndrome criteria, and with cardiovascular/respiratory dysfunction were randomised to receive AZD9773 (2 single dose and 3 multiple dose cohorts) in a double-blind, placebo controlled, dose escalation study
750831|NCT00614991||
750832|NCT00614939||A total of 572 participants were enrolled in the study; 561 entered the Lead-in period and 170 patients were randomized and treated.
750833|NCT00614926|dates of recruitment were June 2006 through October 2007 at at the MDA-ALS Neurology Clinic at Columbia University.|Medical exclusion criteria were low thyroid levels which led to 3 patients excluded.
750834|NCT00614913|Patients with a diagnosis of hepatocellular carcinoma were recruited from the hepatology clinic at Loma Linda University Medical Center to participate in this trial.|Patients with documented metastatic disease were excluded from this trial.
750835|NCT00614874|Recruitment was through pulmonary and allergy/immunology clinics from September 2008 to November 2009.|32 patients assessed for eligibility. 16 did not meet inclusion criteria. None of the 16 participants allocated to treatment were excluded before the study began.
750836|NCT00614822|Between November 2007 and March 2012, 50 patients were enrolled in the phase II trial of carboplatin, pemetrexed and bevacizumab. Patients were enrolled over a 24month period.|Carboplatin, Penetrexed and Bevacizumab in Advanced Non-Squamous Non-Small Cell Lung Cancer
750837|NCT00614744|Multicenter randomized trial to evaluate whether induced hypothermia with body cooling initiated between 6-24 hours of age and continued for 96 hours in infants >= 36 weeks gestation with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18 months of age. Eligible infants were enrolled from 05/06/08 to 07/12/14.|
750838|NCT00614614||A total of 1558 subjects (1276 in the Menhibrix 1 Group and 282 in ActHIB- Infanrix Group) were enrolled; however, 4 of these subjects never received vaccine. Thus, 1554 subjects (1272 in the Menhibrix 1 Group and 282 in ActHIB- Infanrix Group) were vaccinated during primary vaccination phase.
750839|NCT00614575|The number of patients enrolled was 1089. The number of case reports collected from the patients enrolled in this survey was 1071. Moreover the number of patients analyzed as safety analysis was 1044, because 27 patients were excluded due to protocol violations.|
750840|NCT00614523|First Subject Enrolled: 21 July 2008, Last Subject Enrolled: 16 December 2010.|
750841|NCT00614484|Subject were recruited from the radiation oncology clinic from 11/99 through 4/11.|
750842|NCT00614458||
750843|NCT00614445|This is a double-blind, randomized, multicenter, placebo-controlled study in the treatment of NVP. On Day 1, all patients will receive 2 tablets of study drug at bedtime. During Days 2-14 the patients will receive 2 tablets of study drug at bedtime plus additional study drug based upon the need for control of their nausea and vomiting.|The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day. After randomization, patients will return to the clinic for evaluation on Day 4 (+/-1 day) and Day 8 (+/-1 day), and will return on Day 15 (+/-1 day) for an end of study visit. The study duration is expected to be 15 days.
750844|NCT00614432||
750845|NCT00614406|Potential subjects may also have learned about the study from an OHSU Center for Women's Health provider.Visit 1: reviewed of medical history and demographics and vital signs. A blood draw and urine pregnancy test was performed. Eligible subjects returned for the enrollment.|
750846|NCT00614393||
750847|NCT00614380||
750848|NCT00614315||
750849|NCT00614198|Recruitment via multiple associations|92 participants were initially identified for possible study recruitment. 82 participants were available for possible study allocation; 10 participants dropped out prior to randomisation for various reasons, leaving 72 participants.
750850|NCT00614120|A total of 51 centres in three countries: China (17), India (24) and South Korea (10)|A metformin run-in period of 3 weeks followed by a metformin maintenance period of 3 weeks before randomisation with dose levels increased to 2000 mg/day. Subjects already on metformin therapy at enrolment could go through a modified titration period or advance directly to the metformin maintenance period at the discretion of the investigator.
750851|NCT00614055|The trial was conducted at 22 sites in 5 countries: France (4 sites), Germany (5 sites), Norway (5 sites), Romania (3 sites) and Spain (5 sites).|During a run-in period of 2 weeks, metformin was up-titrated to 1500/ 2000 mg/day, which was maintained for 1 week. Subjects who tolerated the metformin dose for a week and had a median of 3 self measured glucose values before breakfast, on 3 consecutive days before randomisation, of ≥ 7.5 mmol/l, were randomised to 1 of the 3 treatment groups
750852|NCT00613951|The trial was conducted at 27 sites in 5 countries: Finland (4), France (4), Germany (6), Poland (9) and Spain (4).|Subjects underwent a run-in period of up to 3 weeks (including 1-week maintenance period) where metformin was up-titrated to 1500 or 2000 mg/day. Subjects who tolerated metformin dose for a week and had fasting plasma glucose ≥ 7.5 mmol/L were randomised to SIAC 30 (B), SIAC 45 (B) or BIAsp 30 twice daily.
750853|NCT00613938|The recruitment period for this inpatient, multicenter study occurred between January 28, 2008 and October 3, 2008.|The study consisted of a screening period (duration up to 28 days), and a double blind active treatment period (4 days).
750854|NCT00613925|January 2008 to August 2009; Academic outpatient OB/GYN clinic|73 women enrolled; 3 excluded (1 cervical stenosis;1 had to have another procedure; 1 biopsy not indicated)
750855|NCT00613834||
750856|NCT00613821||
750857|NCT00613730|Participants were enrolled from 26 March 2007 through 13 April 2007|
750858|NCT00613626||
750859|NCT00613574||
750860|NCT00613509|Participants were enrolled from 20 May 2008 to 31 March 2009 at 8 medical centers in the US and 3 medical centers in Canada.|A total of 23 participants who met the inclusion and exclusion criteria were enrolled and treated.
750861|NCT00613405|Participants were recruited primarily through community advertisements between January 2008 and June 2009.|
750862|NCT00613379|Recruitment was from December 2007 to August 2008|Subjects screened up to 12 weeks
750863|NCT00613366|February 2007-March 2010 in general OB/GYN clinic at an academic hospital|Women desiring IUD placement who were nulliparous were enrolled.
750864|NCT00613327||
750865|NCT00613314|The protocol specified that the study will consist of 16,000 subjects. However, there are only 15, 268 case report forms (CRFs) submitted|
750866|NCT00613301||
750867|NCT00613106|Participants that completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 (NCT00450658) or Horizon Protocol HZ-CA-303 (NCT00460216) without developing an upper gastrointestinal ulcer and who were expected to continue to require daily administration of an NSAID for at least the coming six months were eligible to enroll.|Participants continued to receive treatment with the same double-blind study drug (either HZT 501 [ibuprofen 800 mg/famotidine 26.6 mg] or ibuprofen 800 mg administered TID) they received while participating in Protocol HZ-CA-301 (NCT00450658) or Protocol HZ-CA-303 (NCT00460216).
750868|NCT00613080||
750869|NCT00613028||
750870|NCT00613015|Participants were recruited between April 2008 and May 2012. Participants were primarily recruited through newspaper and television advertisements and respondent driven sampling. All study procedures took place at the Medical University of South Carolina.|50 participants were enrolled and dropped for unknown reason. 22 participants were enrolled but failed the urine drug screen. 2 participants were unable to complete due to obtaining employment. 2 participants completed procedures, but were later discovered to have bipolar disorder. Their data was not used.
750871|NCT00612924||
750872|NCT00612807|Older, maritally-distressed couples with a depressed spouse were recruited via flyers and referral for participation in a study on couples therapy in older adults. Recruitment for Phase I occurred from 10/2006 to 5/2007; recruitment for Phase II occurred from 7/2007 to 5/2009.|No participants who met eligibility criteria were excluded before assignment to treatment condition.
750873|NCT00612768|The study was conducted at 4 centers in the United States. The first subject was enrolled on Jan 2 2008 and the study completed on Dec 12 2008.|No subject was excluded from the trial following enrollment but before assignment to a group.
750874|NCT00612716||
750875|NCT00612690||
750876|NCT00612677||
750877|NCT00612586||
750878|NCT00612573|Recruitment began 4 Mar '08|
750879|NCT00612560||
750880|NCT00612534||
750881|NCT00612508||
750882|NCT00612456|This study was conducted at 22 centers in the United States, Belgium, Italy and Australia between 18 February 2008 and 27 January 2009. A total of 70 participants with Age-related macular degeneration (AMD) were randomized to the study.|
750883|NCT00612430||
750884|NCT00612352||
750885|NCT00612339|Subjects were accrued between October 2007 and September 2008 within the clinic at Duke Comprehensive Cancer Center.|
750886|NCT00612313|200 participants began acute phase open-label treatment with fluoxetine. Of these, 144 entered the randomized control study. Results data presented are for 144 participants randomized.|
750887|NCT00612235|The 3 participating sites enrolled 60 women with epilepsy, 20 in each of the 3 antiepileptic drug groups, and 20 normal controls between 4/1/2008 and 3/31/2010. All of the women met inclusion and exclusion criteria. No enrolled subject was excluded after enrollment.|Since the original conceptualization of the study, phenytoin use declined among women with epilepsy in the general population to the point that we did not identify a sufficient base population in our initial screen to proceed with enrollment of this group and the decision was made at the start of the study to exclude this drug group.
750888|NCT00612222|Four participants were enrolled in this study.|
750889|NCT00612105||
750890|NCT00612066|Recruitment period May 2006-May 2009|
750891|NCT00612040|A total of 28 centres participated: Australia (5), Germany (6), Norway (6), Sweden (5) and United States (6).|
750892|NCT00611975||
750893|NCT00611923||115 subjects enrolled in the screening phase of the study. 27 subjects qualified for randomization and 25 of those agreed to participate in the treatment study.
750944|NCT00609518||"Completed is defined as:The patient has completed follow-up visits until 12 months after the randomization date.
~Qualified Intent-to-Treat (Q-ITT) is defined as: Include all randomized patients, with nonsquamous histology, who comply with their pretreatment folic acid and steroid supplementation schedule and take at least one dose of pemetrexed."
751025|NCT00605865||
751440|NCT00586716||
750894|NCT00611897|"The study was approved by the institutional review boards of Yale Medical School and the Veterans Administration Connecticut Healthcare System. Healthy volunteers were recruited by advertisements.
~as determined by Structured Clinical Interview for DSM-IV, Non-Patient Edition."|All subjects gave written informed consent. They had no personal or family history of psychiatric or substance abuse disorders. A total of 43 subjects consented; 21 of them never initiated the study due to ineligibility or scheduling conflicts, and 6 subjects dropped out. Sixteen subjects completed the study procedures.
750895|NCT00611884|There were 28 sites: Canada (4), India (4), South Africa (3) and the United States of America (17).|Subjects underwent a run-in period of 3 weeks; 2 weeks of up-titration period, where metformin was up-titrated to 1500 or 2000 mg/day, followed by 1 week of maintenance period. Subjects who tolerated 1500 or 2000 mg/day of metformin for a week and had a median fasting plasma glucose ≥ 7.5 mmol/L (135 mg/dL) were randomised.
750896|NCT00611858|Participants were enrolled from May 2008 through July 2012.|
750897|NCT00611806||189 Participants were screened for enrollment, but 49 were excluded. 40 were ineligible, 2 withdrew consent, 1 terminated because of an adverse event, and 6 were terminated because of study visit noncompliance.
750898|NCT00611767||
750899|NCT00611715|This study enrolled patients from November 2003 through July 2008.|Fifty-one patients consented, one was ineligible and two withdrew before receiving study drug.
750900|NCT00611624||
750901|NCT00611559||
750902|NCT00611533||
750903|NCT00611468|The study was open to enrollment at one community oncology clinic from June 2006 to November 2008.|Informed consent was obtained from all subjects. All subjects underwent a screening period that could last up to 4 weeks during which pre-study assessments were completed. All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment.
750904|NCT00611455||Study OFA110635 was comprised of a 24-week Double-blind (DB) Period, followed by a 120-week Open-label (OL) Period. Participants who completed the OL Period, or who were withdrawn, entered a Follow-up (FU) period (approximately 2 years).
750905|NCT00611442|Gastroenterology Clinic, Brooke Army Medical Center, Fort Sam Houston, TX October 2007 to January 2008|
750906|NCT00611403||
750907|NCT00611351||
750908|NCT00611325||
750909|NCT00611247|42 subjects consented to screening for this study.|6 of 42 subjects did not meet eligibility criteria and did not receive induction therapy. Of these, 1 subject had no evidence of AML; 1 had acute lymphoblastic leukemia, and 4 had disease progression and death before induction. None of the 6 were stratified to a treatment group, and were not treated on study.
750910|NCT00611130|01/08-01/09 at 11 US research trial sites.|After Informed Consent obtained, subjects entered a 2-4 week Screening/Baseline Phase to determine whether all Inclusion/Exclusion Criteria were met. Randomization strata included gender, primary method of cocaine administration (snort or intravenous/smoke) & use in last 30 days (≤18 days or >18 days)
750911|NCT00611026|Participants with urgency incontinence Overactive Bladder (OAB) symptoms who met all entrance criteria were randomized to the double-blind treatment period.|3867 participants entered the single-blind placebo run-in period; 2417 participants completed single-blind placebo run-in and progressed to randomization in the double-blind treatment period.
750912|NCT00610987|After IRB approval, patients undergoing ORIF of closed fractures that had a planned postoperative stay of at least 23 hours were randomized to either receiving 23 hours of cefazolin or a placebo.|After IRB approval, patients undergoing ORIF of closed fractures that had a planned postoperative stay of at least 23 hours were randomized to either receiving 23 hours of cefazolin or a placebo.
750913|NCT00610883||
750914|NCT00610857||
750915|NCT00610740|5 additional patients were consented, but never treated.|
750916|NCT00610727||
750917|NCT00610714|Patients were recruited at 58 cancer clinics in 12 countries (Bulgaria, Canada, Denmark, France, Netherlands, Norway, Peru, Portugal, Romania, Russia, Spain and UK) between April 2008 and March 2009.|Following enrolment there was a 28 day screening period, after which if all inclusion/exclusion criteria were met, patients were randomized to treatment.
750918|NCT00610701||
750919|NCT00610688||
750920|NCT00610675||Participants who completed base studies P05706 (NCT00482612) and P05707 (NCT00506389) were eligible to enroll in follow-up study P05708
750921|NCT00610649||
750922|NCT00610558||There is no pre-assignment for this study
750923|NCT00610532|Patients were recruited between Feb 2006 and Sept 2007.|
750924|NCT00610480|Subjects with dry eye disease will be recruited from Ophthalmology clinic patients and otherwise healthy volunteers who are students or employees of the University of Texas Southwestern Medical Center.|
750925|NCT00610467||
750926|NCT00610441||
750927|NCT00610428||
750928|NCT00610363|The study was conducted at 27 study sites in United States (US) between 19 November 2007 and 16 October 2008. A total of 154 participants were screened in the study.|Out of 154 participants, 83 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive either Placebo or Rilonacept 160 mg.
750929|NCT00610311|Three participants was enrolled in this study.|
750930|NCT00610207||
750931|NCT00610168||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
750932|NCT00610155||
750933|NCT00610129||
750934|NCT00609986|Patients were recruited from the Medical University of South Carolina prior to receiving a renal transplant.|
750935|NCT00609973|This study was a pilot multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of ciprofloxacin for the prevention of postoperative recurrence in patients with CD. The study was conducted at 6 centers between January 2008 and March 2011. 33 patients were randomized.|There were no significants events pre-assignment
750936|NCT00609947|Subjects were recruited by local and regional medical centers from December 21, 2007 through November 22, 2010.|Subjects were excluded from participation if they did not meet inclusion/exclusion criteria and fall into the category of per protocol small vessel stenting - 2.25mm, 2.5mm and 2.75mm - single or multi-vessel (Rev K).
751763|NCT00572195||
750946|NCT00609466|The recruitment period for this in-patient, multicenter study occurred between 04 September 2007 and 11 December 2007.|The trial consisted of a Screening Period (Day -28 up to the first surgical incision on Day -1), a Surgical Period (Day -1 to Day 1 at approximately 03:00 h.), a Qualification Period (Day 1), a Double-Blind Treatment Period (Day 1 up to Day 4), and a Follow-up Period (Day 8 up to Day 18).
750947|NCT00609362|Recruitment commenced january 2008 and ended february 2009. Participants were recruited by ads in local papers and called our osteoporosis clinic. 179 called and after a course description 150 were sent information. After having read that 74 paid a visit to the clinic.|74 individuals were screened. 17 were screen failures due to exclusion criteria. 57 were randomized.
750948|NCT00609336||
750949|NCT00609271||
750950|NCT00609245||
750951|NCT00609167|Sixty-three(63) participants were recruited between December 2006 and October 2008 at either Mayo Clinic Arizona or Princess Margaret Hospital.|
750952|NCT00609128||
750953|NCT00608985|First subject, first visit was on 28 April 2008. The last subject, last visit (safety follow-up) was on 30 September 2009.|There was a screening period of 14 to 28 days. Two randomized subjects (one in each almorexant (ACT-078573) dose group) did not receive double-blind study treatment. The 'Started population' was defined as those participants who were randomized and treated.
750954|NCT00608959|Subjects were enrolled at a single center in the US, from 12 May 2008 - 03 June 2008. Subjects who participated in Part 1 were allowed to participate in Part 2 after a one week washout period.Subjects were not required to participate in both Parts 1 and 2 of the study.|Subjects required screening skin samples ( from an average of 2 samples) containing at least 2.5log10 colony forming units per cm2 (CFU/cm2)
750955|NCT00608907||
750956|NCT00608894||
750957|NCT00608881||
750958|NCT00608868|From January 2007 to July 2008, 156 subjects were enrolled from 11 centers in Korea. First subject in date: 17 January 2007. Last subject last visit(Data cut off) date: 2 January 2009.|The subjects were able to provide sample of EGFR mutation test and the subjects who had positive EGFR results or satisfy more than two condition of adenocarcinoma, female or non smoker were eligible.
750959|NCT00608842||
750960|NCT00608829||
750961|NCT00608777|Recruitment from January 2008 through December 2008. Subjects recruited from physician data base.|Subjects experiencing mild localized breakthrough associated with Raptiva use were recruited.
750962|NCT00608634||
750963|NCT00608582|July 2002-March 2013. Recruited in hospital setting and outreach with affiliated and local clinics VA Boston Healthcare System, Boston, MA; Hospital of the University of Pennsylvania, Philadelphia, PA|Assessed for eligibility by telephone screen, or in-office visit. Assessment included review of medical history. Total Excluded (n = 38) Not meeting inclusion criteria (n = 31) Declined to participate (n = 2) Other reasons (n = 5)
750964|NCT00608569|Participants were recruited across 9 study sites (2 in Peru, one each in South Africa, Haiti, Uganda, Botswana, Zimbabwe, Brazil and Zambia) in the AIDS Clinical Trials Group system between April 2009 and September 2011.|Five hundred twenty nine subjects including participants and partners entered the study. Among the 529 subjects, 259 were participants, which included two participants with eligibility violations. Only the 257 eligible participants were included in the analyses. All participants started TDF/FTC +LPV/rtv and stratified by screening HIV-1 RNA only.
750965|NCT00608543||
750966|NCT00608530|In Study 1 (Psychologist-delivered treatment) recruitment commenced July 1, 2008 and concluded December 31, 2011. In Study 2 (Nurse- delivered treatment) recruitment commenced July 1, 2012 and concluded December 31, 2015. In both studies patients were recruited from VA clinics via flyers, by community newsprint advertisement, and by word of mouth.|In both Study 1 (Psychologist-delivered treatments, N = 66) and Study 2 (Nurse-delivered treatments, N = 67) participants who qualified and enrolled were randomized to their group assignment within 7-10 days of qualification.
750967|NCT00608517|Recruitment period = 9/23/2005 through 8/15/2008|A total of 7 people signed consent to take part in this study. Of those, 1 was determined to be ineligible.
750968|NCT00608491||
750969|NCT00608465||
750970|NCT00608426||At the time of the baseline survey, 1277 subjects were excluded for not meeting eligiblitiy criteria: 428 declined to participate; 201 were misclassfied as cigarette smokers (never used cigarettes or smokeless tobacco user); 444 were former smokers (rather than current smokers); 179 had incorrect mailing addresses; and 25 were deceased.
750971|NCT00608322|We enrolled septic patients in the Emergency Department and Intensive Care Unit|
750972|NCT00608244||
750973|NCT00608205|Patients recruited from Cleveland, Ohio medical clinics from December 2007 to August 2012.|
750974|NCT00608140||
750975|NCT00608062|Participants were recruited from the Denver metro area between March 2007 and March 2012. The first participant was enrolled on March 6, 2007 and the last participant was enrolled in March 2012.|A total of 155 women consented to participate. During screening, 33 women did not qualify (12 premenopausal, 14 perimenopausal [11 early- and 3 late], and 7 postmenopausal). Twenty-three withdrew from participation before baseline testing and 7 women withdrew from participation after baseline testing but prior to randomization.
750976|NCT00608023||
750977|NCT00607997||
750978|NCT00607919||The study comprised a 16-week placebo-controlled, double-blind acute phase and followed by an optional 16-week open-label in which all participants were treated with Atomoxetine.
750979|NCT00607893||
750980|NCT00607880|All patients considered for port implantation for intravenous chemotherapy were consulted and evaluated for port implantation. This evaluation was not study specific. If the implantation of a port system was feasible, the patient fulfilled inclusion criteria and the patient consented to the study, then they were randomly assigned a treatment port.|One patient in the Standard Access Port group was unable to have the port placed due to chronic left internal jugular occlusion and was excluded from the analyses.
750981|NCT00607867||Proposed study design was 20 subjects, 10/arm. (Parallel arm design requested by grant Reviewers.) At the end of the funding period, 14 subjects had been enrolled and studied, 7 in each arm.
750982|NCT00607815||
750983|NCT00607789|All participants were recruited at the Lindner Center of HOPE location.|64 participants were consented. 24 were not randomised: 21 did not meet entry criteria and 3 withdrew consent.
750984|NCT00607724||
750990|NCT00607373||Sixty-one patients were screened and fifty-one randomized. Eligible patients were randomized in a 2:1 ratio to receive 200 mg mipomersen or matching volume placebo subcutaneous (SC) injections weekly.
750991|NCT00607321||
750992|NCT00607269|Recruitment occurred from April 2005 through Feb 2008 via flyers posted throughout the community, and word of mouth.|
750993|NCT00607243||
750994|NCT00607126|Prospective subjects were recruited from the MS clinic population of the UCLA Dep't/ of Neurology and from the general MS population in Los Angeles between 2007-2009. Recruitment flyers were approved by the UCLA Institutional Review board.|38 subjects were consented and randomized; two subjects volitionally dropped out before participating in the study; this accounts for the discrepancy..
750995|NCT00607113|Participants were recruited starting on January 17, 2008 to February 26, 2010. All recruitment was done at The University of Texas MD Anderson Cancer Center.|A total of forty-one (41) participants were enrolled in the trial but two (2) participants were not eligible due to screen failure, therefore, they were not included in the group assignments.
750996|NCT00607087|Multicenter study: 44 active centers from 12 countries in Europe, USA and Asia Pacific region. Study Initiation date: January 8, 2008, Study Completion Date: June 15, 2009.|"359 participants screened; 289 randomized; 288 patients treated (1 patient not treated per physician's decision): 274 with insulin glulisine, 269 with insulin lispro, 266 with insulin aspart.
~The safety population, (N=288 patients randomized and treated) is described in the participant flow and baseline characteristics."
750997|NCT00607048||16 participants were screened, enrolled, and received at least 1 dose of study treatment in Schedule A. 18 participants were screened and enrolled in Schedule B; however, 2 participants discontinued before assignment to study treatment; 16 participants received at least 1 dose of study treatment in Schedule B.
750998|NCT00607022||
750999|NCT00606944||
751000|NCT00606931|Patients were recruited between January & July 2008 at the medical center where they underwent PEM imaging.|The first enrolled participant was excluded from the analysis, the subject signed the consent form prior to the trial being officially released.
751001|NCT00606905|Between November 1999 and February 2008, a total of 82 women were recruited from seven centers: University of British Columbia, University of Chicago, University of Tennessee-Memphis, University of Toronto, Ottawa University, Yale University and McMaster University.|Five of the 82 withdrew consent prior to group assignment.
751002|NCT00606892|Subjects were recruited from the New Haven Connecticut area through newspaper advertisements and fliers from the summer of 2007 thru the winter of 2008.|There was no special pre-assignment procedures for this study. Thirty seven smokers signed a consent form with only 17 randomized. 13 smokers never return to clinic after signing a consent form. 2 smokers were excluded secondary to poor IV access. 5 smokers had dropped out due to a scheduling conflict.
751003|NCT00606801|Abstinent cocaine users recruited from 2007 to 2009 using word of mouth, fliers, and newspaper advertisements. This was an outpatient study conducted in a Yale University & Veteran Affairs substance abuse research clinic.|55 subjects were screened. 21 subjects were excluded. (Not meeting inclusion criteria n=19, declined to participate n=2). These 34 subjects were then assigned to treatment groups. Prior to the 1st day of intervention, subjects underwent an adaptation session where they were familiarized with study procedures, and baseline measures were obtained.
751004|NCT00606684||At Visit (V) 1, eligible participants (par.) entered a 2-week, single-blind placebo Run-in Period (RIP) to establish a stable Baseline. At V 2, eligible par. were randomized to a 28 day, double-blind Treatment Period. 1206 par. were screened, 851 par. entered the RIP and 605 par. were randomized, out of which 602 par. received >=1 treatment dose.
751005|NCT00606632|226 subjects were enrolled at 14 study sites in the USA.|
751006|NCT00606593|242 subjects were screened at 18 centers in the United States and received single-blind placebo treatment. The first subject screening visit was 12 Dec 2007, the first subject was treated on 19 Dec 2007. 112 subjects were randomized, the first assigned double-blind treatment, was on 26 Dec 2007. Last subject, last clinic visit ended on 4 Apr 2008.|The study consisted of a 2-4-week screening phase on single-blind placebo, a 4-8-week treatment phase, and a 28 day safety follow-up. Subjects were randomized to one of 10 treatment sequences.
751007|NCT00606580||
751008|NCT00606554|Recruitment start 1/2008 recruitment end: 5/2010 Recruited from Medical Intensive Care Unites Boston medical Center|
751009|NCT00606502|Patients were enrolled between January 2008 and June 2009 across 43 study sites in 6 countries.|
751010|NCT00606489|Participants were patients admitted to the study centers who had second and third degree thermal burns covering more than 10% total body surface area, including the face.|
751011|NCT00606320||
751012|NCT00606307||
751013|NCT00606294||
751014|NCT00606281||
751015|NCT00606229||
751016|NCT00606177||
751017|NCT00606138|Subjects will be recruited starting in 2007 and until sufficient subject population is reached. They will be seen in an eye clinic at Rush University Medical Center.|There is no wash-out period. Recruited subjects must be in need of treatment for their PDR, and will be randomized and treated at the baseline visit.
751018|NCT00606086|38 Investigators in the U.S. (30 in U.S., 3 in Europe, 5 in India) were recruited to participate in this study. First subject was screened on November 12, 2007 and the last subject was screened on March 7, 2011.|
751019|NCT00606047||
751020|NCT00606034|Subjects recruited between Dec 2008 and Dec 2009 from clinic at Mountain Diabetes and Endocrine Center.|Patients who had failed any previous insulin regimen with HbA1c over 7% and requiring over 100 units of insulin per day were enrolled and switched to treatment with U500 insulin via Omnipod.
751021|NCT00606021||Induction phase (IP) is from first dose of study drug until randomization and entering to maintenance phase (MP) or discontinuation from treatment during IP. 106 participants were treated during IP. MP is from randomization to discontinuation from treatment. Overall period is IP+MP, whereas overall study is MP only.
751022|NCT00606008|Patients must have had pathologically or neuroradiographically recurrent AA or GB and prior pathologic confirmation of primary tumor histology. Patients with prior low-grade glioma were eligible if histological transformation to malignant astrocytic gliomas (MAG) was confirmed before enrollment.|Study patients were stratified by tumor histology (AAor GB).
751023|NCT00605917||
751024|NCT00605904||
751026|NCT00605839|Subjects were recruited from the pediatric diabetes clinics at the James Whitcomb Riley Hospital for Children in Indianapolis, IN. Adolescents with type 1 diabetes between the ages of 14 and 18 years living with at least one parent participated.|
751027|NCT00605826||
751028|NCT00605813||
751029|NCT00605722||
751030|NCT00605696||
751031|NCT00605657|All patients were started on valproic acid at the NIH Clinical Center then followed locally|
751032|NCT00605644||
751033|NCT00605566|Patients were recruited from January 2008 to October 2010.|
751034|NCT00605540||
751035|NCT00605475||
751036|NCT00605423||
751037|NCT00605384|A total of 84 subjects were to be treated with entecavir (ETV) plus tenofovir (TNF) or adefovir (ADV) added to continuing lamivudine (LVD).|"Of the 4 subjects enrolled, 2 were not randomized (reasons: Subject no longer meets study criteria and Other). Both subjects randomized were treated as well."
751038|NCT00605358|Older adults who were eligible for home-meals delivery were recruited into the study if they screened positive for depressive symptoms. Screens were completed by home meals staff, while all research interviews were completed by trained research assistants.|"A number of participants were excluded from the trial after screening but prior to randomization, due to the following reasons:
~Non-English speaking, active suicidality, starting new antidepressant or therapy, cognitive impairment, substance abuse, psychosis."
751039|NCT00605345||
751040|NCT00605319||
751041|NCT00605306||
751042|NCT00605293||
751043|NCT00605280|Original protocol included 0.3, 0.03, and 0.003 milligram (mg) pegaptanib sodium and sham treatment groups; the 0.03 and 0.003 mg doses were removed, affected participants given option of receiving 0.3 mg injections of pegaptanib sodium or study withdraw. Later, participants who hadn't completed Year 2 were eligible to enroll in Year 3 extension.|
751044|NCT00605267|Participants were recruited from 4 research sites in Japan: Hakata (Fukuoka), Kumamoto (Kumamoto), Nagoya (Nagoya), Osaka (Osaka). The study initiation date was October 2007 and the study completion date was January 2010.|A total of 197 participants were recruited into this study and 98 were randomized to Anastrozole (20 mg once daily oral dose) and 99 were randomized to Tamoxifen (1 mg once daily oral dose) with one subject voluntarily discontinuing prior to receiving treatment Tamoxifen.
751045|NCT00605202||
751046|NCT00605189||
751047|NCT00605176|Recruitment started on January 15, 2008 all subjects were randomized by March 17, 2008. The studies were performed at 26 investigational centers in the United States.|Subjects were screened and had to meet eligibility requirements for randomization. The most frequent reason for screen failure (104 of screen failures) was that the subject did not have between 5 and 20 visible or palpable Actinic Keratosis (AK) lesions on either the face or the balding scalp.
751048|NCT00605150|Total number of patients treated with TheraSphere was 11.|Candidates were selected by the physicians for treatment with TheraSphere, patient's signed informed consent and were treated if they met the criteria for treatment using the Humanitarian Device Exemption (HDE) protocol.
751049|NCT00605085||
751050|NCT00605072||
751051|NCT00605033||
751052|NCT00604968||28 patients were screened and 25 were enrolled. All 25 patients enrolled received >=1 cycle of treatment with Caelyx. Per protocol, treatment was to continue until progression, unacceptable toxicity, or other reason for discontinuation of treatment - all subjects eventually discontinued treatment but were considered to have completed the study.
751053|NCT00604890||
751054|NCT00604825|The study was conducted from at 75 centers (2 in Spain, 3 each in Argentina, New Zealand and the United Kingdom, 4 in Italy, 5 in Australia, 6 in Sweden, 12 in Germany, and 37 in the United States) from 17-July-2007 to 23-July-2008.|A total of 982 healthy postmenopausal participants with moderate to extremely severe vasomotor symptoms were screened (626 screen failures) and 356 were randomized.
751055|NCT00604812|Panel C was added to the study by amendment after enrollment of Panels A and B were completed.|
751056|NCT00604786||
751057|NCT00604721||
751058|NCT00604708||
751059|NCT00604695|The study randomized 40 primary percutaneous coronary intervention (PPCI) patients from 6 hospitals in the United States. The patients were given either a volume matched bolus of intracoronary (IC) tenecteplase (TNK) (4 mg; n=20) or IC saline placebo (4 mg; n=16) before and following PPCI. 4 subjects were randomized but did not receive 1st bolus.|
751060|NCT00604669|170 charts reviewed|Nothing to disclose.
751061|NCT00604565||
751062|NCT00604552||
751063|NCT00604500||
751064|NCT00604461|This study was Open to Accrual (recruiting) for a period of 2 years (10/04/07 through 10/05/09). Recruiting ended on 10/05/09 due to slow accrual, as requested by pharmaceutical company.|
751065|NCT00604383||This study consisted of a 36-month treatment phase and a 0 to 6-month extended treatment phase. Completers are those who completed the 36-month treatment phase.
751066|NCT00604279||
751067|NCT00604214||
751068|NCT00604201||
751069|NCT00604188|188 participants were recruited in this study.|188 participants were randomized in the study; however one did not receive any study medication. Therefore the intent-to-treat (ITT) population was 187 participants.
751070|NCT00604175|319 HIV-infected women 13-45 years of age were recruited in US, South Africa and Brazil between March 2008 and July 2011 for participation in this study.|"Participants were enrolled into 3 strata based on screening CD4 cell count:
~Stratum A: CD4 cell count >350 cells/mm^3
~Stratum B: CD4 cell count >200 to <=350 cells/mm^3
~Stratum C: CD4 cell count <=200 cells/mm^3"
751071|NCT00604162|8 Hospital sites|Four patients withdrew before completing the study documents and were not included in the analysis.An additional 8 patients were not included in the analysis of the accuracy of polyp detection.
751072|NCT00604045||
751073|NCT00604019|Dates of enrollment were from July 2005 thru July 2008 at RUSH University Medical Center in the Medical Intensive Care Unit|
751074|NCT00603993||
751075|NCT00603980||Each participants was to receive all 7 interventions in a randomized order in a crossover design
751792|NCT00570674|29 participants were enrolled between November 2007 and August 2011.|
751076|NCT00603941|"A total of 19 participants who met all inclusion and no exclusion criteria were enrolled in the study; 15 received treatment.
~Due to low enrollment, no participant had a dose limiting toxicity, therefore a maximum tolerated dose required for the recommendation of Phase 2 dose could not be established. Therefore, the study was halted prematurely."|Sequential cohorts per dose level were treated with CS-7017 and paclitaxel in accordance with prospectively defined dose levels, dose escalation rules, and definitions of treatment-related dose-limiting toxicity (DLT).
751077|NCT00603915|Study was activated on 14-June-2006. Patients with nasopharyngeal carcinoma meeting the eligibility criteria specified in the protocol were enrolled.|
751078|NCT00603902||
751079|NCT00603889|Recruitment occurred between March and May 2008, primarily by means of advertising the study in and around The George Washington University, where the study site is located.|
751080|NCT00603837|Mothers were approached on the labor and delivery floor to consent for their child's participation in this study. Recruitment took place from May 2007 to November 2008.|Three enrolled babies were not included in the analysis. One was found to have a birth weight greater than the cut-off, one was randomized to the wrong group, and one had an unrecorded delivery room temperature.
751081|NCT00603798|Recruitment started on January 15, 2008 and all subjects were randomized by March 6, 2008. The studies were performed at 26 investigational centers in the United States.|Subjects were screened and had to meet eligibility requirements for randomization. The most frequent reason for screen failure (44 of screen failures) was that the subject did not have between 5 and 20 visible or palpable lesions on either the face or the balding scalp.
751082|NCT00603746||Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline safety evaluations and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. 1175 par. were screened, and 627 par. were randomized, out of which 622 par. received at least one dose of study treatment.
751083|NCT00603733|"Total number of unique patients enrolled in the study is 288 whereby 190 patients were enrolled in the Active Phase and 98 patients were enrolled in the Run-In Phase.
~The patients enrolled in the Maintenance Phase are a combination of patients who completed the Active (82) and Run In (71) Phases and were eligible to move forward into Maintenance."|
751084|NCT00603720||
751085|NCT00603642|Participants were enrolled from 20 November 2007 through 11 December 2008|
751086|NCT00603590|Between July 2006 and January 2007, 1,733 subjects attended the Kalaleh heart clinic. Of those assessed 872 were included in the run-in phase of the study. Of these 475 were randomized.|"872 subjects entered the run in phase, 258 were excluded. Most exclusions were due to laboratory test results.
~614 completed the run-in phase of the study, 65 were excluded. Most were excluded because they did not attend the clinic.
~Of 549 subjects remaining, 74 were not randomized.
~475 subjects who were randomized."
751087|NCT00603564|The Steering Committee requested an interim analysis at 20% enrollment in order to monitor the criteria for actual equipoise of the two treatments. Being this unplanned, the Lan-DeMets approach was followed and a manifest superiority of the CPAP treatment was identified, with a nominal alpha exceeding the criterion for interruption set at 0.00008.|
751088|NCT00603538||
751089|NCT00603525||Study OFA110634 is comprised of a 24-week Double-blind (DB) Period, followed by a 120-week Open-label (OL) Period. Participants who complete the OL Period, or who are withdrawn, enter a Follow-up (FU) period (anticipated to be approximately 2 years).
751090|NCT00603512||
751091|NCT00603473|Participants were screened at 27 centers in Japan.|Ninety subjects were enrolled in the study. Of them, 89 received the study treatment, while 1 withdrew consent.
751092|NCT00603447|This was an open-label study of carfilzomib (CFZ) given in combination with lenalidomide (LEN) and low-dose dexamethasone (DEX) in patients with relapsed multiple myeloma. The study consisted of a dose-escalation portion and an expansion portion. Participants were treated until disease progression (PD) or unacceptable toxicity.|In the dose-escalation portion, participants were enrolled in sequential cohorts to determine the maximum tolerated doses (MTD) of carfilzomib and lenalidomide. In the expansion portion either the MTD or the maximum planned dose (MPD) from Cohort 6 (if no MTD was determined) was administered to gain additional safety and efficacy information.
751093|NCT00603408||
751094|NCT00603382||Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline, safety evaluations and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. Total 1459 par. were screened, 601 were randomized of which 598 par. received at least one dose of study treatment.
751095|NCT00603304|A total of 1032 men were prescreened for Complementary and Alternative Medicine for Urological Symptoms (CAMUS), usually by telephone; interested and preliminary eligible men were scheduled for a first screening visit.|
751096|NCT00603291||
751097|NCT00603278||Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline safety evaluations and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. 1406 par. were screened, and 622 par. were randomized, out of which 615 par. received at least one dose of study treatment.
751098|NCT00603265||
751099|NCT00603239||A total of 165 patients, experiencing inadequate glycemic control using a thiazolidinedione (TZD) alone or in combination with metformin, following a 2-week placebo lead-in period, were randomly assigned in a proportion of 2:1 to add exenatide (111 patients) or placebo (54 patients) to their current therapy regimen.
751100|NCT00603187|Subjects were recruited via fliers on the University of Washington campus.|Healthy, non-smoking male subjects between 18-50 years of age were recruited. Health was determined by physical exam, medical history intake and laboratory blood tests.
751101|NCT00603044||
751102|NCT00603018||
751103|NCT00602979||
751104|NCT00602953||
751105|NCT00602927|Participants were recruited from mass media advertising in the greater Philadelphia area from November 2007 - June 2008.|All participants completed a 14 day wash-out period between the two study phases. They were instructed to resume their usual smoking behavior in this wash-out phase.
751106|NCT00602836|Forty-five (45) participants were recruited at Mayo Clinic (Rochester, Florida and Arizona) between March 2009 and December 2009.|One participant was deemed ineligible and is excluded from all analyses per study design.
751107|NCT00602797||
751109|NCT00602667|293 participants were enrolled between December 17, 2007 and April 19, 2017.|Of the 293 participants enrolled, 3 were ineligible and removed from study, leaving 290 eligible patients. Eighty-one (81) of the 290 eligible patients enrolled had histologically confirmed medulloblastoma; medulloblastoma patients are the focus of the primary study objectives.
751110|NCT00602641|The study was activated on February 29, 2008 and closed to accrual on November 30, 2011 with final accrual of 306 patients.|
751111|NCT00602537||
751112|NCT00602472||
751113|NCT00602459|From January 2008 to August 2012, 418 participants were recruited to this study.|
751114|NCT00602446|Only one site (Masonic Cancer Center) enrolled patients in this study.|4 patients were consented, however, one withdrew consent before receiving treatment.
751115|NCT00602420||
751116|NCT00602355||
751117|NCT00602290||181 participants were enrolled in the study and 38 participants dropped out before randomization. A total of 143 participants were assigned to groups.
751118|NCT00602225||
751119|NCT00602043||
751120|NCT00601965||
751121|NCT00601952||
751122|NCT00601926||
751123|NCT00601900||
751124|NCT00601848||
751125|NCT00601835|Participants were enrolled in the study from 06 May 2004 through 13 December 2004, in 2 medical sites (4 investigators) in the US.|"A total of 3,651 participants that met the inclusion and exclusion criteria were enrolled in the study. One participant declined vaccination.
~The immunogenicity subsets consist of all participants ≥ 60 years of age; the safety subsets consist of all participants ≥ 60 years of age and one third of participants 11 to 59 years of age."
751126|NCT00601796|24 participants were accrued at a single center from 10/2006 to 6/2008.|
751127|NCT00601731|Participants were enrolled at 3 sites (1 site in the UK and 2 sites in Canada).|
751128|NCT00601718||
751129|NCT00601705||
751130|NCT00601640|184 participants were accrued. 18 were accrued when an interim analyses resulted in a change in formulation and dosing. The primary analyses is based on 166 accrued after this change.|166 participants were accrued after the change in formulation. 10 participants were not randomized for various reasons. 156 participants were randomized to one of the 3 treatment groups.
751131|NCT00601627||
751132|NCT00601523||
751133|NCT00601458|"First Patient Entered: 25 July 2007
~Last Patient Last Visit: 28 January 2008
~1 site"|
751134|NCT00601419||
751135|NCT00601367||
751136|NCT00601354|Participants were recruited through newspaper advertisements and flyers. The study took place at an outpatient psychiatry department of a large university medical center.|There was no wash out, run-in, or transition following participant enrollment.Exclusion criteria are described previously. Main exclusion was weight less than 27 kg/m2.
751137|NCT00601250||
751138|NCT00601172|This study was conducted at 89 centers (55 centers in Europe, 30 in North America and 4 in Korea) in 11 countries from 10-March-2008 to 13-April-2009.|All participants received ondansetron and dexamethasone as background antiemetic therapy. To assure adequate blinding, placebo to match casopitant was used. Participants were screened within 14 days of first dose of study anti-emetics and were randomly assigned to either single dose intravenous (IV) (90 mg casopitant) or control (placebo).
751139|NCT00601146||
751140|NCT00601107|The study was conducted at 19 centers in the United States of America between April 01, 2008 and June 09, 2009.|A total of 195 participants were screened of which 84 (43.1%) were screen failures; main reason for screen failure was participant did not qualify for randomization. A total of 111 participants were randomized.
751141|NCT00600938||Patients randomized to 1 of 2 treatment grps ICL or DFO, 20 mg/kg/day once daily for 2 wks, followed by 30 mg/kg/day od for 1 wk and 40 mg/kg/day od (DFO) target dose of 50 to 60 mg/kg/day 8 to 12 hour for 5 to 7 days/wk. In ext. pts could either stay in the same grp from core or could switch grps: ICL to ICL, DFO to DFO, DFO to ICL and ICL to DFO
751142|NCT00600886||
751143|NCT00600821||
751144|NCT00600756|"This study was a 1-year, randomized, prospective, parallel, open-label study. The study was conducted in 114 study centers in 13 countries.
~OR International multi-center study, 180 sites recruited between January 2008 and October 2009."|"Screening for eligibility. Patients with a SWN-K total score ≤ 75 were entered into the study.
~All patients with no intake of IP and missing SWN-K total score at baseline or following baseline were included in the study Overall Number of Participants but these patients are excluded from the ITT Analysis set!"
751145|NCT00600743|Recruitment at St. Luke's Hospital from 2/22/08 through 2/19/09|Subject had to rate test food greater than 6 on a 9 point scale of liking and have BMI between 19 and 27
751146|NCT00600704|This prospective study was conducted in our University Hospital over a 20-month period, after approval from the Institution Ethics committee, and written informed consent was obtained from all patients before entering the study. All the participants were patients of the Cardio-Thoracic Clinic of our Hospital.|Exclusion criteria were emergency or re-do operations, operations starting after 18.00, administration of tissue plasminogen activator (TPA) or other thrombolytic medications, pre-existing hematologic disease or coagulation abnormality, advanced cirrhosis, renal failure, preoperative blood product transfusion, combined cardiac and carotid surgery.
751147|NCT00600613||
751148|NCT00600353|20 patients undergoing Autologous Stem Cell Transplant (ASCT) for multiple myeloma (MM) (n=10) and relapsed lymphoma (n=10) at the University of Kansas Medical Center were enrolled. 2 patients were excluded from analysis - both patients met exclusion criteria|"Emetic responses were assessed by daily patient diaries and the Multinational Association for Supportive Care in Cancer Antiemetic Tool (MAT). Nausea was measured using a Nausea Visual Score (NVS) of 0 to 10 with score of 0 having no nausea. A modified Osoba module was used to assess quality of life (QOL)."
751149|NCT00600340||
751225|NCT00596167|Subjects were recruited from the Indiana University School of Medicine Short-daily hemodialysis clinic. The recruitment spanned 2007 to 2009. A total of six subjects were recruited.|Following completion of a subject's scheduled HD treatment, intravenous access will be maintained.
751226|NCT00596102|study participants were recruited from 44 study centers previously participating in study IC51-301 and IC51-302|
751793|NCT00570531||
751150|NCT00600171|614 participants were randomized to study drug; however, 7 of these participants were randomized in error and did not receive any study drug. 607 participants comprised the Intent-to-Treat Population (all participants randomized to treatment and who received at least one dose of study medication).|Participants were screened (Visit 1), for eligibility, which included the inhaled albuterol/salbutamol reversibility test. Following screening and a 14-day Run-in period, participants meeting eligibility criteria were stratified in an approximately 1:1 ratio according to their Baseline Forced Expiratory Volume per one second (FEV1).
751151|NCT00600119|This multicenter study was conducted in Canada, Germany, Romania, and the United States between 04 January 2008 and 23 March 2009.|The study duration was up to 11 weeks, consisting of an initial screening period lasting up to 10 days, a 14-day OIC confirmation period, during which the OIC diagnosis was confirmed, a 7-day single-blind placebo run-in period, a 29-day double-blind treatment period, and a follow-up visit 2 weeks after the last dose of study drug.
751152|NCT00600106||
751153|NCT00600080|Sixty subjects were enrolled onto the study to wear contact lenses for two weeks on a daily wear basis.|Sixty subjects enrolled and sixty subjects completed.
751154|NCT00600067|Subject recruitment occurred in 10 investigative sites in the U.S. between January 2008 and October 2008|
751155|NCT00600028|Consecutive eligible patients were recruited by the investigators from their clinics and through self-referral between February 2008 and March 2011. 98 persons contacted our study coordinator with queries about the trial, 22 from the Johns Hopkins Interstitial Lung Disease Clinic and 76 in response to the ClinicalTrials.gov Web site.|One participant was excluded because of an FVC>90% predicted
751156|NCT00600015||
751157|NCT00599924||
751158|NCT00599872||
751159|NCT00599755||
751160|NCT00599521|Multi center study recruitment period: First subject enrolled Nov 6, 2007; last subject completed Nov 14, 2008|Washout requirements: 2 weeks for systemic anti-inflammatory drugs, 4 weeks for oral antibiotics, 2 months for inhaled/nasal steroids and 6 months for hormonal contraceptives/therapies.
751161|NCT00599339|The study started to enroll subjects in June 2006. Overall, 2195 patients were enrolled in this study (Enrolled Set [ES]), of which 2179 were treated with rotigotine or another Parkinson's disease treatment according to the study protocol at least once (Safety Set [SS]).|"There were 36 patients without valid data consent. Therefore only Safety data were analyzed for these 36 patients.
~Patients without valid data consent or an unknown study termination status were neither considered as completer nor as non-completer in the Clinical Study Report. These patients are considered as non-completers in the summary below."
751162|NCT00599326||
751163|NCT00599313||
751164|NCT00599248||Enrollment and assignment of patients in Arms 2 and 3 (dose escalation to sequentially higher doses) was only performed after completion of review of safety data in the previous Arm (lower dose) by the Independent Data Monitoring Committee
751165|NCT00599196|An Open-Label Extension to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Early-Stage Idiopathic Parkinson's Disease from August 2002 to December 2008|One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
751166|NCT00599131||
751167|NCT00599053||
751168|NCT00599027||
751169|NCT00599014|All participants were stable patients with heart failure. They were recruited during one of their visits to heart failure clinics. The recruitment period started in November 2007 until December 2010. This was an observational study with no interventions.|All patients willing to participate to the study were enrolled. Because this was an observational study, no patients with heart failure (ischemic and non-ischemic) were excluded from participation. Only patients with congenital and infiltrated etiologies were not eligible for the study.
751170|NCT00598871|Recruitment started in January 2008 and ended February 2009 using 4 sites (Hospital Medical Centers). Only the first dose group was completed before suspending the trial due to low patient availability.The procedure of debridement was discontinued in most centers, thus making the availability of surgical subject extremely small.|Prior to randomization, patients needed to meet specific inclusion and exclusion criteria.There was no run-in period.
751171|NCT00598832|Multi center study recruitment period: First subject enrolled Nov 7, 2007; last subject completed Nov 6, 2008|Washout requirements: 2 weeks for systemic anti-inflammatory drugs, 4 weeks for oral antibiotics, 2 months for inhaled/nasal steroids and 6 months for hormonal contraceptives/therapies.
751172|NCT00598819|Healthy Volunteers|Physical Exam to confirm healthy status. The physical exam was performed by the investigator that is a licensed Medical Doctor.
751173|NCT00598806||
751174|NCT00598702|Multi-center study conducted in the United States from 19 Mar 2008 - 24Dec 2008|"No subjects were entered into the Infants (29 days to 1 year old): IV APAP 6.7 - 12.5 mg/kg q4h group"
751175|NCT00598689|80 subjects were recruited over a period of four months. Subjects were recruited from the pool of patient scheduled to have Laser Assisted in situ Keratomileusis (LASIK) surgery at the Medical College of Georgia/Eye Care One Laser Vision Center, Augusta, Georgia.|Subjects were stratified based on smoking status.
751176|NCT00598663||"Cross-over design
~1 month run-in before randomization
~4 month wash out period"
751177|NCT00598650||
751178|NCT00598585||
751179|NCT00598559|Open label study conducted in the US from 21 Feb 2008 -12 Aug 2008|
751180|NCT00598507|Accrual began in May 2007 at Moffitt Cancer Center and was completed in October 2008.|
751181|NCT00598481|The Pivotal study enrolled 12 participants.|
751182|NCT00598442||
751183|NCT00598273||
751184|NCT00598078||
751185|NCT00597935||
751186|NCT00597909||One participant was enrolled but did not receive drug or was randomized.
751187|NCT00597896||
751188|NCT00597818||Of 124 participants recruited, only 121 were actually enrolled.
751189|NCT00597766|Subjects were recruited from an urban, academic rehabilitation center from 10/2007 to 6/2012 in the United States.|Subjects had to have a positive Neer's test (50% pain reduction by subacromial lidocaine) to be enrolled and randomized. 59 were screened. 28 subjects were consented and enrolled.
751190|NCT00597753||
751191|NCT00597727||
751192|NCT00597714|170 transplant recipients were recruited through the Adult Bone Marrow Transplant Program at Duke University Medical Center. Recruitment began in February, 2008 and ended in June, 2013. 33 recipients were screen failures. 94 donors were consented for leukapheresis.|Recipients had history and exam, labs, x-ray, and possible bone marrow aspirate. Radiation therapy may be used prior to transplant for minimal active disease. Donor selection included a 5-6/6 matched sibling as the first choice, a matched unrelated donor as the second choice, or a 3-5/6 partially matched family member as the third choice.
751193|NCT00597701|Seventy-nine subjects met study inclusion criteria, and provided informed consent for participation in the study.|Of 79 enrolled subjects, 44 developed signs of Alcohol Withdrawal Syndrome (AWS) sufficient to meet Diagnostic and Statistical Manual, 4th version, revised (DSMr-IV) criteria for AWS. These 44 were randomized to receive baclofen or placebo, in addition to benzodiazepine therapy. Of the 44 subjects randomized, 31 completed 72 hours of observation.
751194|NCT00597675||
751195|NCT00597584||
751196|NCT00597558||
751197|NCT00597545||
751198|NCT00597519||
751199|NCT00597506|The recruitment process started in October 2007 and was complete in April 2009. All subjects except one were enrolled at the Morris Cancer Clinic at Duke University Medical Center. One subject was enrolled at the Community Memorial Healthcenter in South Hill, Virgina which is a Duke Oncology Network clinical research site.|
751200|NCT00597493||
751201|NCT00597428|Recruitment period: 06 August 2007 through 06 March 2009 Recruitment sites: 84 U.S. investigative sites and 4 Canadian investigative sites|Safety evaluable population (listed below under 'Started') includes all subjects who randomized and dosed. NOTE: these numbers are based on 1 miss randomized subjects - randomized to Lubiprostone and received Placebo. ITT population includes only those subjects who dosed and provided at least one post-treatment efficacy assessment.
751202|NCT00597402||
751203|NCT00597376|Between March 2008 and September 2009, persons expressing study interest at community presentations or at the Rush Memory Clinic were contacted. Of 524 persons expressing interest, 400 were excluded before consenting for having excluding clinical diagnoses(227), participation refusal (119), and other exclusions medication (54).|Consented participants underwent a screening evaluation to ensure inclusion criteria were met prior to study treatment assignment and one month run-in treatment with a multivitamin only. Of 124 consented individuals, 20 discontinued prior to randomization due to new medical conditions (9), declining participation (5), and for other reasons (6).
751204|NCT00597272||
751205|NCT00597246||
751206|NCT00597207||
751207|NCT00597116|"First subject enrolled: 17 December 2007, Last subject last visit: 22 July 2009.
~The study was conducted at 2 centres in Switzerland and 4 centres in Germany."|
751208|NCT00597038|Eligible patients had unresectable stage III or stage IV melanoma. Patients were required to have measurable or evaluable disease and prior treatment with dacarbazine or temozolomide was not allowed.|
751209|NCT00597012|The Meniscal Tear in Osteoarthritis Research (MeTeOR) trial was performed in seven academic referral centers with enrollment occurring from June 2008 through August 2011.|
751210|NCT00596960||
751211|NCT00596947|Study was terminated early due to low enrollment.|
751212|NCT00596934|Patient recruitment occurred from February 2007 and concluded in October 2007.|One of ten enrolled participants screen failed during baseline visit, liver biopsy showed no non-alcoholic steatohepatitis. Therefore he is not included in any tables or analyses.
751213|NCT00596830||
751214|NCT00596817|Patients were in- and outpatients from psychiatric settings.|The study consisted of two consecutive periods: a 12-week open-label treatment period with Vortioxetine and a double-blind, fixed-dose, placebo-controlled treatment period of at least 24 weeks.
751215|NCT00596752|This study started to enroll subjects in March 2004 in order to end up with 840 enrolled subjects. The study was conducted using a two-stage group sequential adaptive design with possible sample size adjustment after the planned interim analysis, which was performed after stage 1. After the interim analysis subjects were included in stage 2.|Participant Flow refers to the Randomized Set (RS). RS consists of all subjects randomized into the study who have completed the study or terminated prematurely.
751216|NCT00596687|Enrolled patients with a BG 140-400 mg/dL with DM for more than 3 months,aged 18-80 yo, treated with diet alone, any combination of oral antidiabetic agents, or lowdose insulin in 2008-2009. Study was conducted at Grady Memorial Hospital,Emory University Hospitaland the Veterans Administration Medical Center.|Exclusion criteria included hyperglycemia without a known history of diabetes, cardiac surgery, clinically relevant hepatic disease or impaired renal function (serum creatinine ≥3.0 mg/dL), history of diabetic ketoacidosis (20), pregnancy, and any mental condition rendering the subject unable to give informed consent.
751217|NCT00596635|Four dementia units participated in this study. Exclusion criteria included: 1)indwelling catheter, 2)residence <4 weeks, 3)prednisone therapy, 4)active UTI symptoms, 5)terminal, 6)end stage renal disease, 7)<60 years old, 8)chronic suppressive antibiotic therapy, 9)history of kidney stones, 10)unable to provide baseline urine, 11)warfarin therapy.|If a participant could not provide a baseline urine specimen or met an exclusion criterion prior to group assignment but after consent, he or she was not enrolled.
751218|NCT00596622||
751219|NCT00596466||Participants were eligible for the current study A0081160 (NCT00596466) if they adequately responded to pregabalin treatment in protocol A0081047 (NCT00524030).
751220|NCT00596453||3 participants were enrolled but were removed prior to arm/group assignment. One participant was not eligible for the study and the other two participants changed their minds about being part of the research study.
751221|NCT00596440||
751222|NCT00596427|Participants with type 2 diabetes. All pre-existing drug treatments were stable for at least 3 months prior.|Participants excluded based on fasting plasma glucose levels, fasting serum triglyceride levels, LDL-cholesterol levels, pregnancy or a history of liver, biliary, or intestinal diseases. Participants treated with insulin or lipid agent less than six months prior were excluded as well.
751223|NCT00596362|"Protocol Open to Accrual: 04/10/2007
~Protocol Closed to Accrual: 05/13/2008
~Primary Completion Date (if applicable) 05/13/2008
~Recruitment Location is the medical clinic"|
751224|NCT00596271|First Subject In: 26.09.2005, Last Subject Out: 14.07.2006 performed at centers for travelling medicine/vaccinology|
751227|NCT00596011|Participants were enrolled at the Moffitt Cancer Center and 7 other sites in the United States, from September 2008- March 2013.|Participants were block randomized by diagnosis to receive Polyphenon E®) (PolyE) containing 400 mgs (-)-epigallocatechin-3-gallate (EGCG) per day (n=49) or placebo (n=48) for 1 year.
751228|NCT00595959|Patients were recruited from investigator patient referral base. Recruitment occurred between November 2006 and March 2007|Patients were screened for inclusion/exclusion criteria
751229|NCT00595946|Recruitment period: 03 August 2007 to 06 March 2009 Recruitment sites: 77 U.S. investigative sites and 3 Canadian investigative sites|Safety evaluable population, defined as all participants who were randomized and dosed, according to the product actually received.
751230|NCT00595920||
751231|NCT00595881|Patients were recruited over a 22 month period|
751232|NCT00595868||Enrolled sample size of 220; 2 were excluded because found to be ineligible after enrollment
751233|NCT00595790||
751234|NCT00595764||
751235|NCT00595621|Diabetic gastroparetic patients who qualified to participate in this study based on inclusionary criteria were recruited from the Gastroenterology Motility Clinic of KUMC in Kansas City, KS|"All subjects underwent an open-label phase where multi-channel gastric pacemaker (MGP-1) was turned ON for 6 weeks. After this phase they were randomized in double blind fashion to MGP-1 ON or OFF for another 4 weeks. 3 participants were not randomized to continue the study after the open-label phase."
751236|NCT00595582|Subjects were initially recruited for an MCI study which was IRB approved 9-29-03 and subjects were recruited from a medical clinic and advertising.|
751237|NCT00595556||
751238|NCT00595530|Three patients were recruited from the sickle cell population from PI's clinic and the hematology/oncology clinic|There were no pre-assignment details
751239|NCT00595517|First participant enrolled 2 Oct 07. Last completed 8 Sept 09. 395 enrolled, 130 registered in study. All registered were included in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy, safety analysis set for summaries of safety variables.|Out of 395 enrolled participants, 130 participants were registered and 265 participants were not registered. The major reasons of no registration were 'Incorrect enrollment' (247 participants) and 'Voluntary discontinuation by participant' (18 participants).
751240|NCT00595504|Subjects were recruited from the Freedom Trial Clinic at the Erich Lindemann Mental Health Center and were studied at the Mallinckrodt General Clinical Research Center (GCRC) at the Massachusetts General Hospital (MGH), Boston|After providing written informed consent, subjects underwent a diagnostic evaluation by a research psychiatrist using the Structured Clinical Interview for DSM-IV (SCID). All subjects were screened and enrolled based on eligibility criteria. Baseline study assessments were completed prior to intervention.
751241|NCT00595478||
751242|NCT00595465||
751243|NCT00595413||
751244|NCT00595361||
751245|NCT00595335||
751246|NCT00595309|subjects participating in preceeding study IC51-309 were contacted. First Subject In December 2007, Last Subject In March 2008; study sites: center of pharmacology and travel clinics|subjects participating in study IC51-309 without major Protocol Deviations
751247|NCT00595270||
751248|NCT00595231|A total of 239 subjects were randomized into the trial from 19 of the 20 study sites initiated.|
751249|NCT00595153|The MAST study enrolled 103 adults with asthma and 24 healthy controls between 8/2007 to 6/2011. Participants were seen in a clinical research center.|Steroid naïve asthmatics had bronchoscopy before and after an 8 week treatment with inhaled corticosteroids, and asthmatics already taking an inhaled corticosteroid had their treatment standardized for 8 weeks followed by a bronchoscopy. Healthy control subjects participated in a cross-sectional study for characterization and bronchoscopy.
751250|NCT00595127||
751251|NCT00595114||
751252|NCT00595101||
751253|NCT00595088|First patient first visit 12 Feb 2008, Last patient first visit 19 Sep 2012. All patients were recruited at the medical sites|Patients had to be H19 positive to be recruited
751254|NCT00595075|Healthy volunteers were recruited|Participants received 1 dose of ramelteon or placebo during the first inpatient visit and then returned approximately four weeks later for the other condition, counterbalanced for order
751255|NCT00594958||
751256|NCT00594945||"Based on preliminary PK data, the study was terminated early prior to achieving planned enrollment numbers.
~Cohort 1 was dosed at 2mg. Cohort 2 was dosed at 3mg. Two subjects participated in both Cohorts."
751257|NCT00594932|A total of 27 patients with SLE and active arthritis (with or without other manifestations) were randomized 1:1 to receive mycophenolate mofetil (MMF) or placebo. A total of 13 received MMF and 14 received placebo for the first 3 months. For the second three months patients could elect to continue on open lable MMF|Patients were excluded if they did not have arthritis sufficient to be treated with an aggressive immune suppressant. All patients were offered steroid rescue at baseline, those who required immediate treatment and/or who could not be given steroids were excluded from the study
751258|NCT00594906||
751259|NCT00594880|locations: medical clinics (Hospital of the University of Pennsylvania, Jonathan Lax clinic, Drexel University Hospital) Recruitment period: may 8, 2008 to May 27, 2010|subjects were randomized to the pegasys dose of 180 or 90 mcg/week four weeks after enrollment (week 0: eligibility determination; week 4: enrollment; week 8: randomization and treatment initiation; week 13: ART interruption; week 25: primary endpoint; week 37: secondary endpoints)
751260|NCT00594854|Multi-center US study, 16 sites recruited subjects between November 2007 and June 2008. On May 2, 2008 POZEN reached agreement with the FDA to terminate the study based on difficulty in recruiting subjects.|Screening for eligibility and wash-out of restricted medications.
751261|NCT00594815|Protocol Open to Accrual 08/08/2002 Protocol Closed to Accrual 03/10/2009 Primary Completion Date 02-23-2016 Recruitment Location is the medical clinic|
751262|NCT00594685||
751297|NCT00593346|The study opened to participant enrollment on March 12, 2004 and closed to participant enrollment on 12/22/2008.|
751298|NCT00593333|Study started in June 2003. Primary completion date December 2008. Study completion date December 2008. Patients were recruited at University of Alabama at Birmingham.|
751299|NCT00593320|The study opened to participant enrollment on 11/06/2007 and closed to participants enrollment on 03/26/2010.|
751263|NCT00594659|Recruitment opened in November 2008 and closed in May 2011. Recruitment practices included newspaper and radio advertisements, flyers, and posters distributed in local businesses and agencies. The study took place at an outpatient psychiatry clinic.|Participants were excluded from trial prior to group assignment for at least one of the following:no evidence of marijuana use in at least 40 of the past 90 days prior to enrollment,participant met criteria for dependence on alcohol or illicit drugs,evidence of illicit drug use or K-2 use,interfering medical/psychiatric illness,or active refusal.
751264|NCT00594646|Participants were recruited from Fenway Health. Patients at least 18 years of age, who contacted Fenway Health and presented within 72 hours after a potential sexual exposure to HIV-1 were asked to participate in this study.|If study coordinator is notified more than 72 hours after exposure occurred, person will not be eligible for study participation; however they will be referred to an on call medical provider for Non Occupational Post-Exposure Prophylaxis evaluation.
751265|NCT00594568||
751266|NCT00594516|The first site opened on 30 November 2007. The recruitment period for this outpatient, multicenter study occurred between 10 December 2007 and 01 May 2008.|The study consisted of screening period (up to 21 days), washout period (from 3 to 7 days), open label (OL) treatment period (3 weeks), followed by a double blind (DB) active treatment period, with crossover design of 2 randomized sequences of tapentadol immediate release (IR) to tapentadol extended release (ER) and tapentadol ER to IR (4 weeks)
751267|NCT00594464||
751268|NCT00594425|First patient entered: February 07, 2007 Last patient last visit (12 week follow-up: July 07, 2008 Last patient last visit (24 week follow-up: September 22, 2008 15 medical derm clinics|Washout periods for prior acne treatment: 14 days for any topical treatment (except medicated cleansers), 1 month for oral antibiotics; 6 months for oral isotretinoin. Patients using birth control pills must have used the same product and dose for at least 6 months and had to agree to stay with the same product and dose for an additional 6 months.
751269|NCT00594399||
751270|NCT00594386|A multicenter Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease with 41 sites in United States and Canada from August 2002 to December 2008|
751271|NCT00594308||
751272|NCT00594256|Rockland Psychiatric Center|
751273|NCT00594230||
751274|NCT00594204||
751275|NCT00594178|Patients recruited from my outpatient and inpatient clinical service who had a spinal cord injury starting on 4/1/2003 and ending on 3/9/2010|Patients were excluded from the study if we were unable to obtain an H-reflex on nerve conduction study due to this being the primary endpoint we were assessing.
751276|NCT00594165|An Open-Label Extension to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Early-Stage Idiopathic Parkinson's Disease from June 2002 to November 2008|Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.
751277|NCT00594100|The study was approved to enroll subjects from a maximum of 40 medical institutions in the United States (including public and academic research center hospitals and private practices).|
751278|NCT00594061||
751279|NCT00594035|Subjects scheduled for spinal procedures requiring a dural incision were considered for study participation. The Study involved 24 investigational sites within the United States. Subjects were recruited from neurosurgery practices between the period of 01 September 2005 (first subject consented) to 06 Feb 2008 (last visit date).|Enrollment was considered the point of randomization. Subjects were randomized intra-operatively after confirmation that all pre-operative and intra-operative eligibility criteria had been met.
751280|NCT00594022||
751281|NCT00594009||
751282|NCT00593957|Recruitment was from 2004 to 2010. Study initiation was delayed due to the closure of Johns Hopkins Medicine Institutional Review Board(JHMIRB). Patients were recruited from our Kennedy Krieger Institute (KKI)medical clinics, physician referrals,and parent organizations. Parents were sent letters of invitation.|Pharmacokinetics in enrolled subjects required her to be a fast metabolizer of Dextromethorphan (DM).
751283|NCT00593918|Study details planned during the first 4 months of the study. Recruitment period began during the RSV seasons from November to May each year from 2003-2008 in medical clinics.|Patients were enrolled if they met the enrollment criteria
751284|NCT00593866||
751285|NCT00593840|The study opened to accrual on 04/11/2007 and closed to accrual 04/07/2014.|
751286|NCT00593827|A total of 176 participants were enrolled by 55 sites in the United States over a period of 12 months.|All the 176 enrolled participants were randomized. Of the 5 participants who did not receive treatment, 2 were due to disease progression, 1 on participant request, and 2 due to other reasons.
751287|NCT00593814||
751288|NCT00593736|Subjects enrolled at 47 sites in the United States from 10 October 2007 to 23 May 2008.|Subjects were screened for 14 days, entered a 7-day placebo run-in, and then were randomized to once-daily (QD) treatment. To enter the double-blind randomization period, subjects must have met the eligible inclusion and none of the exclusion criteria and met sleep diagnostic criteria established during screening polysomnography.
751289|NCT00593684|Patients were enrolled at the Baylor University Medical Center Neonatal Intensive Care Unit between April 2006 and December 2007.|Enrollment and group assignment occurred concurrently.
751290|NCT00593645|Enrollment to the study opened on 11/21/2007 and enrollment to the study closed on 08/11/2008|
751291|NCT00593606|124 patients were screened. 5 patients were run-in failures and 3 patients were screen failures. 116 patients started treatment, i.e. were included into the Safety Set. 114 patients were included into the Full Analysis Set. 99 patients completed the treatment period. 2 patients withdrew after the treatment period. 97 patients completed the study.|
751292|NCT00593554|This protocol had 9 enrolled patients, but one patient never received a transplant nor was randomized. There had been no efficacy or safety data entered for this patient, and they are excluded from the results.|
751293|NCT00593489||
751294|NCT00593450||Note: The Data and Safety Monitoring Committee for CATT recommended excluding the data for all patients (N=23) from one center because of serious protocol non-compliance. Unless specified otherwise, only the 1185 patients enrolled by the remaining 43 centers are included in analyses.
751295|NCT00593385||
751296|NCT00593372||
751300|NCT00593112||
751301|NCT00592943|Twelve healthy human subjects between 18 and 55 years old were sequentially recruited from advertisements.|12 healthy human subjects were enrolled and completed the study. Enrollment was gender-balanced. Six subjects (3 males, 3 females) were be randomly assigned to the C-11 altropane group; six subjects (3 males, 3 females) were be randomly assigned to the C-11 raclopride group, all in an open-label protocol.
751302|NCT00592904||
751303|NCT00592852||
751304|NCT00592839||
751305|NCT00592774||
751306|NCT00592761|Recruitment of participants occurred through The University of Arkansas for Medical Sciences Medical Center Speech Pathology Clinic and newspaper advertisements between February 2003 and February 2010.|Participants were only assigned to a group after their initial evaluation and no exclusions were necessary. Participants were each assigned to receive 2 weeks of treatment and two weeks of no treatment. Assignments were randomized so half began with treatment and half began with no treatment.
751307|NCT00592683||
751308|NCT00592631||
751309|NCT00592553|A total of 185 participants were screened for eligibility, of which 11 participants did not meet entry criteria.|A total of 174 eligible participants were randomized in 1:1:1 ratio to receive either placebo, low-dose ataluren, or high-dose ataluren.
751310|NCT00592488||
751311|NCT00592475||
751312|NCT00592384||
751313|NCT00592358||
751314|NCT00592319|3 years|Many patients, who were eligible for this study, finally declined to participate this study due to a safety concern with Celebrex
751315|NCT00592176||
751316|NCT00592124|Participants in this study were selected from a total of 7 multinational clinical research sites, with first enrollment taking place on 4 March 2009 and last on 3 February 2010.|
751317|NCT00592072||
751318|NCT00592007||
751319|NCT00591942|Subjects needing a dental crown or dental bridge|
751320|NCT00591864||
751321|NCT00591851|Protocol Open to Accrual 12/20/2004 Protocol Closed to Accrual 07/25/2006 Primary Completion Date 06/24/2008 Recruitment Location is the medical clinic.|
751322|NCT00591838|The study opened to participant enrollment on 09/21/2006 and closed to participant enrollment on 11/01/2017.|5 participants in the Phase II portion of study were treated errantly with 10 Gy fractions, rather than 11 Gy fractions, but were included in the analysis as intention-to-treat.
751323|NCT00591825||
751324|NCT00591786||
751325|NCT00591773|Participants enrolled at 74 investigative sites in Argentina, Chile, Mexico, Peru and the United States from 07 September 2007 to 05 March 2009.|Participants with uncontrolled essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
751326|NCT00591760|Sixty-three patients with CHF NYHA class II-IV and GH deficiency were enrolled from December 2004 to December 2006. These patients were consecutively selected from a cohort of 158 ambulatory patients referred to our tertiary care center and, to a minor extent, patients hospitalized for CHF.|Patients recruited during hospital stay were studied after a 3-months period of optimized medical therapy and clinical stability
751327|NCT00591734||
751328|NCT00591721|Recruitment occurred between November 2007 and April 2009 and involved the distribution of advertising through the MS Society and to Illinois residents participating in the NARCOMS volunteer MS patient registry.|190 individuals were enrolled in the study (i.e., signed consent forms), but 9 of them did not complete baseline measures. Therefore 181 continued through the study.
751329|NCT00591591|"OSAS sufferers and Controls have been recruited an tested at:
~Center of Sleep Disorders of the University of Illinois at Chicago.
~Regional Sleep Disorders Center at Carle Foundation Hospital (Urbana,IL).
~University of California-Irvine Medical Center-Center for Sleep Disorders (UCIMC)
~Stanford University -Sleep Disorders Clinic"|
751330|NCT00591578|Participants enrolled at 103 investigative sites from 09 November 2007 to 03 September 2009 (double-blind phase) and 04 March 2009 to 13 March 2010 (open-label extension phase). A total of 984 participants were randomized into the double-blind treatment phase, of which 170 participants entered into the open-label extension phase.|Participants with essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
751331|NCT00591565|Patients were recruited by radio, newspaper and word of mouth|
751332|NCT00591409|Japanese participants who had a surgical procedure using a general anesthesia of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block were enrolled in this study.|
751333|NCT00591370|Protocol Open to Accrual-01/12/2005 Protocol Closed to Accrual-11/27/2007 Primary Completion Date-06/10/2008 Recruitment Location is the medical clinic|
751334|NCT00591344|Patients with Parkinson's disease, confirmed by a Movement Disorders specialist, were self-referred or recruited from Rush University Medical Center (RUMC) between 9/2007 and 7/2011 for PD subjects. Patients were evaluated at the University of Illinois at Chicago (UIC).|Patients were 50 to 67 years; on stable PD meds; and can walk for 6 minutes. Patients were ineligible if they had a neurological history other than PD; significant arthritis; failed the Physical Activity Readiness Questionnaire; had cognitive impairment (indicated by Mini-Mental State Examination score); actively exercising; or had surgery for PD.
751335|NCT00591305|5 month follow up study|There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.
751336|NCT00591266|Participants enrolled at 65 investigative sites in Argentina, Chile, Mexico, Peru and the United States from 03 October 2007 to 03 April 2009.|Participants with uncontrolled hypertension were enrolled in one of three, once-daily (QD) treatment groups.
751337|NCT00591253|Participants enrolled at 74 investigative sites in Puerto Rico and the United States from 30 October 2007 to 30 April 2009.|Black participants with essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
751338|NCT00591240|Urine samples were collected from participants at the Spinal Cord Injury Service at Veterans Affairs Palo Alto Health Care System for assay validation.|
751339|NCT00591227||
751340|NCT00591214||
751341|NCT00591149||
751342|NCT00591019|Patients recruited from treatment clinic, seeking treatment for tinnitus.|
751380|NCT00589602|Patients were recruited from local hospital from January, 2006 through January, 2009.|
751381|NCT00589563||
751382|NCT00589550||
751383|NCT00589472||
751343|NCT00591006|Enrollment began 3/11/2008 and was completed 4/23/2009. Subjects were recruited through flyers posted at UTSW medical clinics.|Subjects were enrolled and randomized to one out of 4 treatments. The study design is a 4-phase crossover study, meaning all subjects received all four treatments during the course of the study. Subjects washed out of each medication cycle for 21 days before beginning the next treatment cycle. Total number of subjects enrolled is 17.
751344|NCT00590980||
751345|NCT00590967|The study opened to patient accrual on 05/01/2003 and closed to patient accrual on 04/24/2008.|
751346|NCT00590954||
751347|NCT00590902||
751348|NCT00590889||
751349|NCT00590863|Participants were recruited from March 2008 through April of 2009, with the last subject completing the study in September 2009. Participants were recruited from six primary care and nine psychiatric care sites within the NIMH Depression Trials Network.|Outpatient enrollees, 18-75 years old, met DSM-IV-TR criteria for either recurrent or chronic MDD. Eligible participants had to be in the index episode for at least two months and to score ≥16 on the 17-item HAM-D. Those with any history of psychotic illness or bipolar disorder, or in need of hospitalization were ineligible.
751350|NCT00590824||Protocol amended to drop cilengitide groups (C and D), proceed with enrollment and randomization into hu14.18- IL2 groups.
751351|NCT00590772|Patients screened in research laboratory|Patients had a run-in to determine symptoms and only if they had congestion with poor sleep and daytime somnolence were they enrolled
751352|NCT00590759||
751353|NCT00590720|A total of 11 subjects participated in this study from 26Feb2008 to 27Dec2008 at 4 sites in the United States of America.|Treatment assignments were determined using a block randomization procedure with a 2:1 ratio (MEDI-528:placebo) via an interactive voice response system on Day 0 before study drug administration.
751354|NCT00590707||
751355|NCT00590590|Participants were recruited from 31 physician offices in the US and Canada between 04Sep2007 to 18Mar2009.|Participants will undergo a screening period of two weeks prior to study assignment.
751356|NCT00590577|The recruitment period was 8 March 2007 (first patient enrolled) to 24 March 2008 (last patient left the study). The study was performed in medical clinics located around the world.|Before assignment to treatment groups, patients stopped taking disallowed medications. At the same time, patients who had not previously taken paliperidone extended release (ER) or risperidone or had previously taken it but were not currently taking another antipsychotic took paliperidone ER 6 mg/day for 4 to 6 days to assess tolerance to the drug.
751357|NCT00590564||
751358|NCT00590538|This study was terminated by the PI before completing enrollment|
751359|NCT00590460||
751360|NCT00590395||
751361|NCT00590369|Jan 2006-March 2008; study recruitment; study stopped due to slow enrollment rate|
751362|NCT00590317|Patients were recruited at one site (Hospital Emergency Department)over a period of March 2005 to September 2008|Patients were excluded if they chose to not participate after being enrolled and receiving medication but did not want to wait be observed for the 120 minute evaluation period.
751363|NCT00590226|This study was conducted at Grady Memorial Hospital in Atlanta, GA and at Rush University Medical Center, Chicago, IL. IRB approval was given at each center and consent was obtained from all subjects. Patients with a h/o T2DM were recruited in 2007.|
751364|NCT00590161|Patients were recruited between December 2006 and February 2009 at the Liver Clinics of both participating institutions.|Patients were randomized in a double-blind fashion. Double blinding was maintained until study completion by all subjects.
751365|NCT00590135||
751366|NCT00590044|This study was conducted at Grady Memorial Hospital, Atlanta, Georgia, and at Hennepin County Medical Center, Minneapolis, Minnesota|A total of 74 patients with DKA were randomly assigned. Of them, 6 were excluded because 4 withdrew consent before or shortly after initiation of insulin therapy, one patient received glargine insulin before resolution of DKA, and one patient was treated with IV aspart insulin instead of regular insulin. The remaining 68 were included in analysis
751367|NCT00590031||
751368|NCT00590018||
751369|NCT00590005|Children were recruited from January 2003 to June 2011 from the Emory Children's Center asthma clinic.|Children with physician diagnosed asthma were enrolled and underwent comprehensive phenotypic characterization consisting of pulmonary function measures, biomarker assessment, and allergy assessment.
751370|NCT00589979|This exploratory, Phase IIb study was initiated on March 6, 2007 at 21 study centers in the United States and completed on June 24, 2008.|During the active Run-in Period, eligible patients applied Lidoderm patches every 24 hours for 28 days. During the 12-week Double-blind Treatment Period, patients were randomized to apply Lidoderm patches or matching placebo patches every 24 hours for 4 weeks and then crossed over to the other treatment for the next two 4-week treatment periods.
751371|NCT00589914|This is a 13 week double-blind study to assess safety and efficacy of flexible dose of Paliperidone Palmitate (50, 100 or 150 mg equivalent) in patients aged 18 years or older with schizophrenia.|In this study 1221 patients were enrolled of which 1220 patients were randomized as 1 patient was enrolled twice. Only the first patient number was included in the all randomized patients, safety, and intent to treat analysis sets. Out of 1220 patients 1214 patients received at least 1 dose of study medication.
751372|NCT00589888||For this study, same 13 subjects were admitted to the General Clinical Research Center at Grady Memorial Hospital in random order on five different occasions to receive either 8-h iv or oral fat loads in either low or high doses or normal saline.
751373|NCT00589849||
751374|NCT00589836||Consecutive patients with clinically indicated MRI and previous satisfactory echocardiographic images on a previously performed study had a research echocardiographic study on the same day as the MRI
751375|NCT00589797|Subjects were screened and enrolled at 19 US health care center sites|
751376|NCT00589784||
751377|NCT00589693|274 enrolled patients were randomnly assigned to the 127 study centers. 524 patients were to be enrolled, however as the study was terminated early only 274 patients were actually enrolled.|Out of 274 randomized patients, 41 patients were excluded (as their sites were GCP Non-Compliant) and 6 patients were not treated. Treated patients=227 (115 doripenem and 112 imipenem-cilastatin).
751378|NCT00589667|Protocol Open to Accrual 09/08/1998 Protocol Closed to Accrual 07/22/2008 Primary Completion Date 07/13/2010 Recruitment Location is the medical clinic.|
751379|NCT00589628||
751385|NCT00589303|Subjects were recruited from 5 sites: (Mayo Clinic in Scottsdale, Arizona; Mayo Clinic in Rochester, Minnesota; Oregon Health and Science University in Portland, Oregon; University of Calgary in Calgary, Alberta, Canada; and The Heart Group in Evansville, Indiana.|
751386|NCT00589290|This study plans to accrue 1.85 patients per month. The expected accrual is 41 patients (25 thymoma and 16 thymic).|
751387|NCT00589277||
751388|NCT00589121||
751389|NCT00589108|Enrollment in the study began on March 1, 2001, and continued through March 1, 2003.|397 subjects were assessed for eligibility and 157 were excluded prior to randomization because they either declined to participate (n=53), or did not meet inclusion criteria (n=104).
751390|NCT00589056||
751391|NCT00588965||
751392|NCT00588952||
751393|NCT00588900|Between March 2008 and May 2010, 5 participants were registered.|
751394|NCT00588861|Patients were recruited by the investigator based on the FDA cleared inclusion/exclusion criteria in the protocol.|The patients were assigned to each group according to the bone cement used with the implant.
751395|NCT00588848|Only 11 subjects were recruited but only 8 successfully completed the study (3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep). This resulted in early termination of the study.|No significant events to report.
751396|NCT00588822|Subjects were enroll from January 2005 to June 2008 at the Mayo Clinic in Arizona, Florida, and Minnesota.|
751397|NCT00588809||A Simon, optimal two-stage design was employed for subjects without FLT3 ITD mutations. The study also included a second cohort of subjects with FLT3 ITD mutations.
751398|NCT00588770|E1305 was activated on August 8, 2008 and closed on February 11,2015, with final accrual of 403 patients.|
751399|NCT00588731||
751400|NCT00588692||
751401|NCT00588666||
751402|NCT00588640||
751403|NCT00588536|Protocol Open to Accrual: 01/10/1995 Protocol Closed to Accrual: 07/25/2006 Primary Completion Date (if applicable): 06/09/2009 Recruitment Location is the medical clinic|
751404|NCT00588471|Subjects were enrolled at the Mayo Clinic in Rochester, MN from 2002 until 2008.|66 subjects signed informed consent, but 9 subjects had to have the PCI procedure too quickly, and could not participate in the study.
751405|NCT00588445||
751406|NCT00588406||
751407|NCT00588380|Healthy volunteers recruited from Olmsted County, MN.|
751408|NCT00588354|Of the 33 patients screened and randomized, 26 enrolled.|Target enrollment was not reached
751409|NCT00588341||
751410|NCT00588237||
751411|NCT00588159||
751412|NCT00588146|Subjects were recruited from Mayo Clinic, Rochester, Minnesota from January 2007 through September 2010.|
751413|NCT00588094||
751414|NCT00587990||This trial, which originally was designed to enroll 45 patients, was suspended after 9 patients were enrolled because of slow accrual.
751415|NCT00587964||
751416|NCT00587860|Participants were identified through community, institutional advertisement, clinicaltrials.gov, through the IFFGD webpage as well as through the outpatient clinics beginning in February 2006. Participants who participated in previous IBS studies were also mailed a recruitment letter to ask if they would be interested in participating.|For this study, there was a 2-week screening and enrollment phase. During this period, participants were screened, a symptom questionnaire was completed, and there was a physician exam. After the in-person screening visit, a phone call was made prior to mailing the study materials to ensure the participant was still willing to participate.
751417|NCT00587847|The study was originally designed to recruit 20 patients but only 12 subjects were accrued to the trial before it was stopped due to poor recruitment. Subjects were entered between August 2005 and July 2007. All subjects had Chronic Lymphocytic Leukemia that was previously treated with chemotherapy.|
751418|NCT00587834||
751419|NCT00587795|One subject was recruited from the Mayo Clinic in Rochester, Minnesota in 2007.|
751420|NCT00587769|Patient's were recruited between 10 September, 2007 and 25 October, 2007 in the community surrounding the Mayo Clinic in Rochester Minnesota.|Patients were excluded for not meeting entry criteria
751421|NCT00587678||
751422|NCT00587639|Subjects were recruited from clinical and community referrals at 3 participating sites. The study took place from May 2007 to October 2009.|
751423|NCT00587587||
751424|NCT00587483|Adult patients presenting for cardiac surgery in which aortic cross clamping was anticipated were recruited between 11/2007 and 6/2010|
751425|NCT00587457||A total of 11 participants were enrolled, of which all participants discontinued from the treatment.
751426|NCT00587431|"Protocol Open to Accrual: 07/08/2003
~Protocol Closed to Accrual: 02/28/2006
~Primary Completion Date: 02/26/2008
~Recruitment Location is the Medical Clinic"|
751427|NCT00587288||
751428|NCT00587223|Subjects were recruited from US hospital-based clinics. Recruitment was from December 2007 to December 2008.|A screening period of 1 week was utilized in the study design prior to randomization of study lesions to Apligraf or control at Day 0.
751429|NCT00587171|Nineteen subjects were recruited by 7 community based or institutional based sites between April 2008 and March 2009.|At enrollment, subjects were required to have been treated with at least 16 weeks of single vision spectacles (if needed) or until visual acuity was documented to be stable. The child must have had access to a computer on a daily basis.
751430|NCT00587158|Patients to undergo kidney transplantation at Mayo Clinic facilities in Rochester, Minnesota and in Scottsdale, Arizona and scheduled to receive corticosteroid avoidance anti-rejection therapy were screened for enrollment into the study.|112 patients were approached for enrollment. Of those, 4 patient's treating physicians did not think corticosteroid free immunosuppression was appropriate, 3 had their transplants cancelled, 3 were found to be vitamin D deficient, 1 withdrew consent prior to randomization & 1 had a positive final crossmatch and hence were excluded from the study.
751431|NCT00587132|Subjects were recruited from the Mayo Clinic in Rochester, Minnesota from November 2006 until April 2009.|
751432|NCT00587067|Protocol Open to Accrual 6/24/2003, Protocol Closed to Accrual 7/24/2007, Primary Completion Date 5/19/2016, Recruitment location is the medical clinic|
751441|NCT00586703|21 Patients were recruited through the Adult Bone Marrow Transplant Program at Duke University Medical Center. Recruitment began in April, 2005 and ended in March, 2011. Patients who met the eligibility criteria were approached about the study and informed consent was conducted for those who agreed.|"Prior to donor lymphocyte infusion (DLI), disease state was documented:
~Complete history Physical exam Performance status Routine lab tests Radiographic tests Subjects didn't continue with treatment with disease progression. 2 subjects withdrew consent; 1 had graft versus host disease; 1 died; 1 subject's donor didn't yield enough cells."
751442|NCT00586690|Twenty five participants were recruited through the Adult Bone Marrow Transplant Program at Duke University Medical Center. Recruitment began in May, 2005 and ended in April, 2010. Patients who met the eligibility criteria were approached about the study and informed consent was conducted for those who agreed.|Prior to initiating therapy, donors and subjects will have complete history, physical exam, routine laboratory tests, and/or radiographic tests. Recipients may have Bone marrow aspirate/biopsy repeated to check for prior abnormalities. If disease progression present, patient didn't continue with treatment.
751443|NCT00586664||
751444|NCT00586625||
751445|NCT00586612||
751446|NCT00586573||
751447|NCT00586521|Patients were recruited at Haemophilia treatment centers|All subjects who met eligibility criteria on screening were enrolled into the study and began the on-demand treatment period.
751448|NCT00586508||The reasons for discontinuation listed in the participant flow are the reasons the participants discontinued treatment.
751449|NCT00586495|This was an extension study of Study 11515 (NCT00661375), in which the first subject was enrolled on 10 Nov 2004. This extension study was started in December 2005, and the last subject completed the study on 11 Jul 2008. The study was conducted in 41 centers in Japan.|95 subjects were enrolled in this extension study; 95 were valid for the safety analysis and 94 were valid for the intent-to treat (ITT) analysis. 92 subjects entered Follow-up period which started 30 days after last dose. 3 subjects did not enter the Follow-up period because they died within 30 days after last dose.
751450|NCT00586482|Subjects were recruited from patients evaluated at the Mayo Clinic Pre-Operative Evaluation Center located in Rochester, Minnesota, in preparation for elective surgery.|
751451|NCT00586469||
751452|NCT00586339|HIV+ subjects were randomised to receive either Cervarix or Aluminium Hydroxide vaccines; HIV- subjects were not randomised and all received Cervarix vaccine.|Enrollment was staggered as follows: 1) Enrollment of Human immunodeficiency virus positive (HIV+) subjects with cluster of differentiation 4 (CD4+) cell count >200 cells per cubic millimeter (cells/mm^3) and HIV negative (HIV-) subjects (up to 30 subjects) for blinded safety evaluation; 2) Enrollment of remaining HIV+/HIV- subjects.
751453|NCT00586326|Per the protocol, a total of 125 subjects were to be enrolled at 10-15 nationwide centers. A total of 133 subjects were enrolled at 12 nationwide centers. Patients with DCIS electing to undergo breast conserving therapy with radiation therapy were screened for enrollment.|Consented patients who were willing to enroll were evaluated prior to surgery. The lumpectomy was performed per the usual standard of care. The MammoSite applicator could be placed at the time of lumpectomy surgery or post-surgery in a separate procedure if adequate evacuated cavity was available as assessed by ultrasound.
751454|NCT00586313|Consecutive subjects undergoing EUS with suspected hepatic parenchymal disease|
751455|NCT00586261|Patients were recruited from the Mayo Clinic, Rochester, Minnesota.|
751456|NCT00586196||
751457|NCT00586170||
751458|NCT00586157||36 subjects signed consent, and 6 discontinued/withdrew consent prior to completing one week of treatment. The remaining 30 subjects were included in data analyses and thus reported.
751459|NCT00586105|Subjects were outpatients with histologically or cytologically confirmed, unresectable and/or metastatic, measurable clear Renal Cell Carcinoma (RCC) who had received not more than one prior systemic therapy. They were enrolled between 29 Dec 2005 and 29 Sep 2006 at 4 centers in China and 4 in Taiwan.|A total of 51 Asian subjects were enrolled in the trial. Twelve failed screening (11 protocol violations, 1 adverse event); the remaining 39 received at least 1 dose of study drug.
751460|NCT00586066|Recruitment began in November 2005 and closed in December 2009.|
751461|NCT00586001||
751462|NCT00585975||
751463|NCT00585923|Recruitment was done through the population of Dr. Nunley's practice. Once Dr. Nunley decided that the patient was a candidate for cervical fusion, he discussed the study with the patient. After subject signed the informed consent subject was randomized to the Slotted Hole or the Fixed Hole C Tek™ Anterior Cervical Plate.|Patients were included in this study if the answer to all of the inclusion criteria was yes and the answer to all of the exclusion questions was no.
751464|NCT00585910|Subjects were recruited for this study from Outpatient Psychiatry Clinics, the Clinical Pediatric Psychopharmacology Unit of the MGH, and the MGH's extensive network of partnered institutions. Subjects were recruited from 2004 through 2007.|Some reasons as to why subjects were excluded from the trial before baselining include: being found ineligible, withdrawing consent, and being lost to follow-up.
751465|NCT00585780||
751466|NCT00585715||
751467|NCT00585689||
751468|NCT00585650|Subjects were recruited from the dermatology clinics.|
751469|NCT00585637|This study recruited community-based African American (www.clinicaltrials.gov; NCT00585637). Participants were drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|
751470|NCT00585611||While the record documents 1 participant enrolled in this study, there are no data available to report.
751471|NCT00585585|enrollment began 7/1/2007|7 patients signed consent & 6 patients screen-failed
751472|NCT00585546||Of 19 consented, 1 was a screen fail and did not enter the study protocol.
751473|NCT00585533||
751474|NCT00585494||
751475|NCT00585468||
751476|NCT00585377||
751477|NCT00585351|The recruitment period for this study was from January 2007 to January 2008. Subjects recruited for this study were patients with presumed ischemic stroke or intracranial hemorrhage that were transferred to the University of Iowa Hospitals and Clinics via Air Care helicopter transport.|
751478|NCT00585325|A total of 15 patients were enrolled with 41 VAC dressing changes. Patients could be enrolled into more than one arm.|
751479|NCT00585312|A total of 305 participants were screened, whereof 106 were randomized into the study, and of whom 101 took at least 1 dose of study drug. The clinical study was conducted in 18 centers across 13 countries: Belgium, Czech Republic, Hong Kong, Hungary, Israel, Italy, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, and United States.|The randomization was to be stratified by center, age (≥12 years old versus <12 years old), and familial adenomatous polyposis (FAP) phenotype (negative versus positive). The participants were randomized 1:1 to one of the 2 treatments celecoxib or placebo.
751480|NCT00585286|30 total patients with moderate to severe acne scarring were recruited from 3/2007-5/2008 between two locations. Of these, 15 patients received treatment and 14 patients completed the full course of the study at the University of California, Irvine General Clinical Research Center.|Subjects must not have been treated with other lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 12 months of enrollment.
751481|NCT00585247||
751482|NCT00585221||
751483|NCT00585182|28 patients met eligibility criteria and completed the protocol enrolled from the University of Utah Hospital Inpatient Medical Service|
751484|NCT00585169|Men and women with a primary diagnosis of Pathological Gambling (PG) were recruited between April 2008 through February 2010|Twenty-eight of the 29 enrolled subjects completed the study with only one subject withdrawing due to time constraints
751485|NCT00585104||
751486|NCT00585078|Participants were enrolled from May 2004 to March 2010.|
751487|NCT00585052||
751488|NCT00585039|Children 6 to 17 years who presented to ED with asthma exacerbation of moderate to severe nature.|2 children were excluded from levalbuterol group after enrollment, 1 because the study medication spilled and another because they had received the medication outside protocol timeline. All other enrolled patients completed study.
751489|NCT00585013|Patients were randomized by the research perfusionist using sequentially ordered randomization codes. The randomization codes were generated using a computerized random number generator. The entire care team was blinded to the delivery device and drug delivery. Only the study perfusionist was aware of randomization and delivery.|Seventeen patients consented and were enrolled in the study. There were eight consent failures. One patient was disqualified after consent and randomization due to intraoperative findings of a lesion inconsistent with preoperative diagnosis and change in operative plan.
751490|NCT00584987||
751491|NCT00584948||
751492|NCT00584935|Three patients were recruited from the investigator's practice.|Subjects must meet inclusion/exclusion criteria.
751493|NCT00584922||
751494|NCT00584909||
751495|NCT00584857||
751496|NCT00584844|Enrollment at the Special Immunizations Clinic at USAMRIID is expected to last 5 years and include up to 1,000 subjects who were at risk of occupational exposure to F tularensis.|
751497|NCT00584831||
751498|NCT00584805|138 subjects were enrolled at Special Immunizations Clinic, Division of Medicine, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD|
751499|NCT00584740||
751500|NCT00584727||
751501|NCT00584701|Participants recruitment at the UCDavis MIND Institute from the local community.|
751502|NCT00584558||
751503|NCT00584480|Enrollment took place between October 1, 2007 to April 24, 2009. Children between the ages of 3 and 8 with a diagnosis of Autism Spectrum Disorders (ASD) were recruited from the outpatient autism clinic at the MIND Institute (University of California, Davis).|
751504|NCT00584454|10 subject with negative skin test antigen were enrolled in this study|Patients were excluded from this study if after the skin test antigen erythema (> 30mm) or induration (> 20 mm) occured
751505|NCT00584415||
751506|NCT00584402|Closed to enrollment|Closed to enrollment
751507|NCT00584285||
751508|NCT00584220||Of those 96 enrolled subjects in the study, 7 did not meet the study eligibility criteria and 1 did not receive the study lenses. One enrolled subject was discontinued from the study leaving n=87 who completed the study.
751509|NCT00584194|278 subjects were enrolled at USAMRIID to participate|
751510|NCT00584077|Subjects scheduled to undergo surveillance bronchoscopy were enrolled|
751511|NCT00584012||
751512|NCT00583947||86 subjects were screened: 23 subjects aged 2-5 years and 63 subjects aged 6-11 years.
751513|NCT00583908||
751514|NCT00583804||
751515|NCT00583791||
751516|NCT00583713||
751517|NCT00583700|Between April 2003 and July 2009, 53 breast cancer patients were recruited from the University of Iowa Radiation Oncology clinic and randomized to one of two arms.|
751518|NCT00583661|Subject were recruited at pediatric transplant centers by the implanting physicians.|
751519|NCT00583622|Recruitment Period: December 19, 2007 to January 11, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|One participant of the 13 enrolled did not receive treatment and was excluded from the study.
751520|NCT00583596|Subjects were recruited in medical clinics. The first subject enrolled was September 10, 1999. The last follow-up occurred in the Post Market Surveillance Study on August 29, 2008.|Subjects meeting the inclusion/exclusion criteria of the protocol were included in the original clinical trial.
751521|NCT00583557||
751522|NCT00583492||
751523|NCT00583466|No data on how participants were randomized, and no further baseline data (other than categorical age and sex) are available for this record. The PI has left the institution and has been contacted. Per the PI the data are no longer available and the study has not been published.|
751524|NCT00583453||
751525|NCT00583414||
751526|NCT00583375||17 subjects excluded post-operatively
751527|NCT00583362|Participants who completed the parent study LBSL02 (NCT00071487) through the 24-week extension period, who received belimumab 1 milligram (mg)/kilogram (kg), 4 mg/kg, 10 mg/kg or placebo in the parent study and achieved a satisfactory response were enrolled in the study.|
751528|NCT00583219|Subjects were recruited from November 2006 to March 2009 at Mayo Clinic in Jacksonville, Florida.|
751529|NCT00583115||
751530|NCT00583102||
751531|NCT00583050||
751532|NCT00582998||Some of the participants had multiple fractures (there were a total of 263 fractures and 249 participants). The numbers reflected in the Participant Flow, Baseline Characteristics, and Adverse Events sections reflect participants and not fractures.
751533|NCT00582972|At least 5 years past onset of menopause; not taking proton pump inhibitors|subjects completed a food diary
751534|NCT00582946||
751535|NCT00582933||
751536|NCT00582907|Participants were recruited from October 2008 until February 2010. The study was conducted in 6 clinics in the United States in FMF clinics or clinics in regions where a higher prevalence of FMF is expected based on local population ethnicity.|Participants had an estimated mean ≥1 FMF attack/month for 3 months before screening, and ≥1 attack/month during screening/run-in period. There was a wash-out period of other biologic medications for those using them at screening. 2 subjects withdrew consent, one lacked mutations and one had insufficient attacks and were excluded before baseline.
751537|NCT00582894|Recruitment began February 2005 and concluded around March 2007|
751538|NCT00582816|This study enrolled patients with relapsed acute leukemia and very high-risk solid tumors. The last subject was enrolled in October 2013.|
751539|NCT00582790|The study opened to accrual on 09/30/2003 and closed to accrual on 08/05/2008. Recruitment occured in a medical clinic.|
751540|NCT00582738||
751541|NCT00582712|This study recruited participants from a large cancer research institution in Wisconsin from December 2007 through May 2008.|
751542|NCT00582660||
751543|NCT00582608||
751544|NCT00582556|Subjects were screened and enrolled at the University of Wisconsin Carbone Cancer Center from April 2003 until March 2011.|Of the 44 subjects enrolled, one withdrew from the study prior to receiving any study treatment. As a result there were 43 subjects who received at least one dose of study medication.
751545|NCT00582517||
751546|NCT00582491||44 participants with self-identified cocaine problems responded to newspaper advertisements and passed initial telephone screening. Of those who passed the telephone screening, 29 were found to be qualified for participation after in-person screening. 21 participants entered the study and were subsequently randomized.
751547|NCT00582426||
751548|NCT00582400|Nine patients were enrolled from 10/13/04 to 09/05/07 from the outpatient clinics (both free-world and prisoners). The median age of patients was 57 years (range 50-62) and included 8 males and 1 female.|No patients had previous systemic therapy.
751549|NCT00582361|Patients admitted through the emergency department that met the criteria for the study were approached.|
751550|NCT00582309||
751551|NCT00582205||
751552|NCT00582166||
751553|NCT00582114||
751554|NCT00582075||
751555|NCT00582036|Recruitment was not satisfactory to study completion; study terminated early.|
751556|NCT00582010||
751557|NCT00581971||
751558|NCT00581945||
751559|NCT00581919|Participants were recruited from University of Wisconsin Hospital and Clinics and the Wisconsin Oncology Network between April 2004 and September 2010.|No events between enrollment and group assignment. All subjects are enrolled are assigned to the same group.
751560|NCT00581867||
751561|NCT00581854||
751562|NCT00581828||
751563|NCT00581776||
751564|NCT00581581|Individuals who participated in the parent study (CoolCap) were invited to participate in this follow-up study when they were 7-8 years old. Site investigators contacted prior participants' families by phone for consent. Contact information for the families who consented was provided to a central examiner.|Observational study - determination of outcome at 7-8 years after prior randomization in parent study to therapeutic hypothermia vs standard of care for infants with hypoxic-ischemic encephalopathy who met eligibility requirements.
751565|NCT00581555||
751566|NCT00581542||
751567|NCT00581529||
751568|NCT00581399|Subjects admitted to UCI Medical Center and scheduled for cardiac surgery (Coronary Artery Bypass Graft [CABG] with or without Heart valve repair, Heart valve repair alone without CABG) were randomized to one of two study arms: High Vacuum Chest Tubes or Standard of Care Chest Tubes. The enrollment period was from July 2006 through May 2010.|Only subjects that met specific study inclusion/exclusion criteria were enrolled into the study.
751569|NCT00581386|Patients were recruited from the Memorial Hermann Hospital between 05/30/2007 and 04/15/2009. The patients enrolled were undergoing general anesthesia.|There were no enrolled participants excluded from trial before assignment to groups.
751570|NCT00581360||
751571|NCT00581347|The target population was teens with birthdates between 7/1/92 & 6/30/97 at 8 practices in Rochester, NY. 2 methods were used to identify eligible adolescents;(1)2 insurance plans in the region provided a list of all their pts at these practices. (2)2 practices added to the list all teens who made a visit within 2 years of the study start date.|We preformed a stratified random sample, allocating all adolescents to either an intervention or standard of care group (using SAS 9.1). We stratified by practice, age and gender. For families with 2 or more eligible siblings, we assigned all siblings to the same group. Healthcare providers were unaware of group assignment.
751572|NCT00581308|Data was combined from the following sources: (1) Continued Access Study of the GORE® HELEX® Septal Occluder (PMA Subjects HLX 03-01 - last 87 non-training subjects) and (2) subjects implanted with the HELEX device enrolled in the Post-Approval Study of the GORE® HELEX® Septal Occluder (n=128). The total number of subjects enrolled is 215.|Only subjects with a successful implant of the device were included from each study.
751573|NCT00581256||
751574|NCT00581230|The patients who presented to surgery and met inclusion criteria were enrolled in the study|
751575|NCT00581113|Patients were recruited from 08/2007 through 07/2008 in Radiation Oncology clinic|
751576|NCT00581100||Eighty-five participants were screened for the study; 13 participants were screening failures, and 72 participants were randomized to treatment.
751577|NCT00581061||
751578|NCT00581048||
751579|NCT00580983||90 participants were enrolled however only 80 started treatment. Only 73 participants completed treatment. 7 did not complete the 12 month post radiation therapy (RT)swallowing studies.
751580|NCT00580970|Recruitment period was between between 2007 to 2013 at Virginia Commonwealth University, Stony Point, Hanover Medical Center, Southside Regional Medical Center, and Hunter Holmes McGuire Veterans Affairs Medical Center (VAMC).|Enrollment period was between April 12, 2007 and May 30, 2013. During that time 73 consecutive subjects enrolled in the study, 72 started treatment. A total of 20 subjects were ineligible for analysis because they did not reach 6 months of Lovastatin treatment, resulting in a total of 53 evaluable subjects.
751581|NCT00580957||
751582|NCT00580866||
751583|NCT00580853||
751584|NCT00580840|The study started in December 2007 with subjects from Canada, France, and United States. The primary completion date occurred in December 2010, with study completion in March 2011.|
751585|NCT00580801||
751586|NCT00580788|24 subjects were screened and 14 were randomized in the study. Data from 2 subjects was not included in the analysis as there were not enough subjects in that group for analysis. 12 subjects were analyzed.|
751587|NCT00580723||
751588|NCT00580671|Recruitment opened in November 2007 and closed in February 2011. Participants were referred to the study for substance abuse treatment by school administrators, the juvenile justice system, community therapists, physicians or were self-referred. The study took place at an outpatient psychiatry clinic.|Clients were enrolled into the study and assessed for eligibility, if eligible they were given the choice to proceed. Reasons for ineligibility included no marijuana (MJ) use in past 30 days, failure to meet MJ abuse/dependence criteria, met dependence for another substance, no parent participant, plans to move away, low IQ
751589|NCT00580645||
751590|NCT00580606|Recruitment took place at five university-based medical centers in the United States (Mt. Sinai School of Medicine, Johns Hopkins University, Duke University, National Jewish Medical Center, University of Arkansas Children's Hospital from April 2008 to January 2010.|
751591|NCT00580502||
751592|NCT00580398|This study used a non-randomized design, which began with a usual care control group enrollment period (January 2008-June 2008) that was followed by an intervention group (June 2008-August 2009)enrollment period. We recruited patients referred to thoracic surgery and oncology clinics at the Massachusetts General Hospital (MGH) in Boston, MA.|A patient had to be willing to take varenicline in order to be eligible for the intervention group; if a patient who was otherwise eligible for the intervention group was taking nicotine replacement therapy or bupropion, he/she had to be willing switch to varenicline.
751593|NCT00580372||
751594|NCT00580333||
751595|NCT00580294|study conducted at Mount Sinai School of Medicine, Department of Anesthesiology, Clinical Research Center (CRC), New York, NY, and enrolled patients from August 10, 2007 to August 9, 2008|
751596|NCT00580229|From February 2008 to January 2011 in the medical clinic.|All study participants were treated with open-label standard dose and the recommended infusions of rituximab for rheumatoid arthritis.
751597|NCT00580151|Patients recruited in the medical clinic. Recruitment occured between 11/10/04-7/16/05.|All participants were eligible to participate in the study.
751598|NCT00580138||
751599|NCT00580073|Participants were enrolled between 4/08 and 11/09 from a large cancer research institution.|
751600|NCT00580047|All patients from the Kidney Pancreas Transplant clinic at the University of Nebraska Medical Center who underwent a kidney, pancreas, or kidney-pancreas transplant from 2003 to 2009 were invited to participate.|Participants were recruited during the transplant hospitalization or within 30 days of transplantation. They were excluded if they had an esophageal abnormality, bone density T-score of -3 or lower, fracture in the last 2 years, Cr Cl of 35 or less, inability to sit upright for 30 minutes after swallowing a medication.
751601|NCT00580034|Recruitment began in February, 2003 and ended in February, 2008. Recruitment took place at Duke and Florida hospitals in the Bone Marrow Transplant clinics during time of clinical appointments in a private location.|Prior to selecting a donor: donor and subjects had history and physical exam, labs and chest x-ray performed per program and FACT requirements. Female donors should have a negative pregnancy test. Subjects also had bone marrow. Prior to treatment, disease progression and insurance denial led to removal from the study.
751602|NCT00579982||
751603|NCT00579878||No events occurred prior to assignment of study arm treatments.
751604|NCT00579826||
751605|NCT00579813||
751606|NCT00579670||The use and dosage of ziprasidone for this Non-interventional Post-Marketing Surveillance study was based on the approved summary of product characteristics (SmPC) document and adjusted solely according to medical and therapeutic necessity.
751607|NCT00579527||The goal of this study is survival of subjects after cultured thymus tissue implantation (CTTI) regardless of the immunosuppressive regimen or of parathyroid co-transplantation.
751608|NCT00579501||
751609|NCT00579436|Non-diabetic subjects with either impaired glucose tolerance, impaired fasting glucose, or at least three features of metabolic syndrome were recruited at the University of Kentucky or the University of Arkansas. Exclusion criteria included history of coronary heart disease, inflammatory disease or chronic anti-inflammatory use|
751610|NCT00579345|Study was conducted during the period of October 2007 to June 2008 at five sites in Poland.|All subjects enrolled were included in the trial. The data entered is for overall study.
751611|NCT00579280||
751612|NCT00579254||This was a phase 4, observational, open-label study conducted in patients who were prescribed singlepill Caduet by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.
751613|NCT00579137||
751614|NCT00579111||
751615|NCT00579098|Patients were enrolled in this trial between January 2008 and December 2009 at Mayo Clinic in Rochester, Minnesota (USA).|847 patients were screened and of those, 567 were excluded, primarily because they were already receiving statin therapy (68%) and/or had known inflammatory disease (16%). 280 met entry criteria but 155 were not willing to participate. 125 were enrolled in the study.
751616|NCT00579059|Patients were recruited by the investigator.|There were no pre-assignment details to report.
751617|NCT00578968|Participants were recruited at the Mayo Clinic, Rochester, Minnesota from October 2006 to August 2008. The first period compared cardiovascular response in COPD patients to healthy controls prior to the intervention. In the second period the COPD patients were randomized to drug or placebo; the controls did not take part in this period.|
751618|NCT00578942|This study was opened and first consent obtained on 9/11/2002 and was closed to accrual on 2/18/2008 as enrollment goal was met. Recruitment took place at Duke hospital in the Bone Marrow Transplant clinic during time of clinical appointments in a private location. Follow up for survival was discontinued in April 2013.|Prior to selecting a donor: donor and subjects had history and physical exam, labs and chest x-ray performed per program and FACT requirements. Female donors should have a negative pregnancy test. Subjects also had bone marrow aspirate/biopsy. Subjects were premedicated with Benadryl and acetaminophen.
751619|NCT00578929|The first subject was enrolled in the study on September 8, 2007 and the last subject exited the study on November 24, 2008. The study was conducted at medical clinics throughout the USA.|Subjects completed a 4-16 day run-in period on vehicle prior to randomization.
751620|NCT00578903|Diagnosis SAA, failure to respond to immunosuppressive therapy, lack of HLA identical family member, A 6/6 or 5/6 HLA matched unrelated donor or a 5/6 matched related donor available after high resolution typing, age<60 years|Pirour to initicating the SCT preparatory regimen, patients require a double lumen Hickman catheter and completion of the pretransplant evaluation.
751621|NCT00578877||
751622|NCT00578864||
751623|NCT00578812||Each clinical site could treat up to two (2) non-randomized investigational training patients prior to entering the randomized phase of the clinical trial.
751624|NCT00578786|Participants completing Week 12 of NCT00423748 or NCT00423202 could enroll in extension (E) study. Participants on placebo in parent study and d/c treatment due to >/=2 early escape criteria were eligible. Total randomized: 361 (completed/early escape in prior study), 19 (d/c prior study), and 3 (completed prior study, did not enroll in E study).|Participants on active treatment in NCT00423748 or NCT00423202 continued to receive their last assigned blinded ambrisentan (AMB) dose from the prior study. Those on placebo in NCT00423748 were randomized to receive either 5 or 10 mg of AMB in the extension study. Those on placebo in NCT00423202 were randomized to either 2.5 or 5 mg of AMB.
751625|NCT00578734|Subjects were enrolled at 24 hospitals in the United States and Chile from 04 June, 2007 to 23 March, 2010. Last subject's last visit occurred on 05 April, 2010.|
751626|NCT00578669||
751627|NCT00578643||
751628|NCT00578617||
751629|NCT00578565|Participants were recruited from Mayo Clinic and Brigham and Women's rheumatology outpatient clinics.|
751630|NCT00578552|Recruitment began on 08/07/2007 and completed on 12/10/2008. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, MN and Franciscan Skemp Medical Center in Lacrosse, WI) for consenting and additional study procedures to determine eligibility.|
751631|NCT00578539||
751632|NCT00578461||
751633|NCT00578448|First participant, first visit: 3 March 2008. Last subject, last visit 6 September 2012. Participants had received a renal transplant from a living or deceased donor with an anticipated cold ischemia time of less than (<) 24 hours (h)|14 participants enrolled; 12 received study drug; 2 not treated due to: kidney damage (1) and prolonged cold ischemia (1). Study continued for up to 3 years until drug approval in participant's country. Participants continued in a 1 year extension after conclusion of the 3rd year.
751634|NCT00578383|Subjects were recruited from March 2008 though February 2011. They were recruited through flyers distributed around McLean Hospital (Belmont, MA), referral by clinic doctors and direct recruitment on the hospital's units.|Enrolled participants are excluded from statistical results if they had baseline Hamilton Depression Rating scores under 17 or co-morbid disorders.
751635|NCT00578344||
751636|NCT00578331|Patients were recruited between December 2006 and January 2007 at medical offices in the United States.|Patients were randomized at Visit 1 upon meeting inclusion/exclusion.
751637|NCT00578318|Study patients were recruited from the local community using tested, strategic community engagement procedures.|
751638|NCT00578305||
751639|NCT00578292||
751640|NCT00578279||
751641|NCT00578227||Although the total number of enrolled subjects for this study was 814, one subject did not receive any study vaccine and was therefore not considered as started in the 'Participant Flow' section.
751642|NCT00578214|Patients undergoing outpatient Mohs surgery at the Mayo Clinic in Rochester, MN were included in either the randomized arms (midazolam vs placebo) or in the prospective midazolam arm. The study was performed between March 2007 and June 2008.|
751643|NCT00578175||While the total numbers of subjects enrolled in the study was of 1851, the total number of subjects that entered the study was 1783. The remaining 67 subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.
751644|NCT00578136|52 patients completed the study, having hernia repair as a day-surgery procedure.|We screened 120 subjects and excluded 66, 35 patients did not fit the criteria and 31 patients declined to participate. 54 subjects were randomized to receive either a rectus sheath block or local anesthetic infiltration. Two randomized subjects did not get the intervention. 52 subjects did get the intervention - 26 in each arm.
751645|NCT00578071||
751646|NCT00577993|Recruitment period: March 1998 to May 2002|35 participants without Bcl Gene rearrangement were not randomized to the study
751647|NCT00577889|A total of 21 patients were accrued from May 30, 2008 to September 2, 2010.|A total of 21 patients were accrued and randomized onto one of 3 parallel arms (Arm I: 9 patients; Arm II: 6 patients; Arm III: 6 patients). One patient from Arm I canceled and was not used in baseline analysis nor endpoint analysis.
751648|NCT00577863||Results are reported for participants who received at least one injection of study drug.
751649|NCT00577824||
751650|NCT00577772||
751651|NCT00577720|Screening began 14-Jul-2006|
751652|NCT00577707||
751653|NCT00577655||208 individual subjects were screened; ten subjects failed the initial screening but were later re-screened and successfully enrolled.
751654|NCT00577642||
751655|NCT00577629|Subjects were recruited between September 2005 and March 2011 at Duke University Medical Center.|
751656|NCT00577590||
751657|NCT00577512||
751658|NCT00577473|Screening began 9 Feb 2001|
751659|NCT00577460||
751660|NCT00577408||
751661|NCT00577395|Beginning with the first patient screened on June 18th, 2008, a total of 51 patients were screened for inclusion into the study, of which 38 were excluded from further participation.|The Screening visit was conducted within 45 days of randomization. After obtaining written informed consent, patients underwent a preliminary screening, including Dual Energy X-ray Absorptiometry (DXA) of the lumbar spine and proximal femur. The most frequent reason for screening failure was DXA results.
751662|NCT00577382|The study, conducted at 7 medical centers, was activated on August 8, 2007 and closed on August 1, 2014. Patient enrollment to Cohort A occurred from September 2007 to January 2009 and Cohort B from March 2009 to June 2013.|The trial was amended in 2009 to revise sunitinib dosing due to difficulty with tolerability and evidence of progressive disease following treatment breaks. As such, there are two study cohorts: the first employing intermittent dosing of Sunitinib (Cohort A) and the second with continuous dosing (Cohort B).
751663|NCT00577356|Recruitment from Feb. 08 through September 08 at Virginia Mason Medical Center|Eligible patients had histologically confirmed adenocarcinoma of the prostate with clinical stage 1-3, no evidence of metastatic disease, and were appropriate candidates for radical prostatectomy with an estimated life expectancy >10 years.
751664|NCT00577135||
751665|NCT00577122|Since there was not enough evidence of clinical benefit, this study did not go beyond the first stage in the two stage design. A total of 30 patients (14 in the MPA alone cohort and 16 in the MPA+ ldoCM cohort) were in the study before the study ended.|
751666|NCT00577096|Study conducted at multiple myeloma international referral center included patients newly diagnosed & eligible for treatment with aggressive treatment. Protocol included tandem peripheral blood stem cell transplants.|
751667|NCT00577083||
751668|NCT00577031||
751669|NCT00577005|Thirty three cocaine and opioid dependent treatment seeking individuals were recruited by newspaper advertising, word-of -mouth and referrals from community-based substance abuse clinics. Research staff obtained informed consent and subjects were evaluated for study eligibility.|Twenty eight subjects were assigned to treatment groups while concurrently receiving treatment with methadone. Randomization was balanced with urn procedure on gender and severity of cocaine use score.
751670|NCT00576927|Subjects were long-stay residents of NHs in the Atlanta area who were > age 65. Potential subjects were initially screened using administrative data and medical record review. Potential subjects who do not meet any of the exclusion criteria after initial screening were approached for informed consent or proxy consent was obtained when applicable.|Those for whom consent was obtained underwent a clinical assessment and baseline measures . Only subjects with 5-night average sleep latency > 20 minutes and/or sleep efficiency <80% were included . Subjects with severe sleep apnea were excluded and referred to their primary physician. Subjects unable to tolerate the actiwatches were excluded.
751671|NCT00576901||
751672|NCT00576836||The goal of this study is survival of subjects after cultured thymus tissue implantation (CTTI) regardless of parathyroid co-transplantation. No subject underwent CTTI with parathyroid transplant.
751673|NCT00576823|This study was conducted at 19 sites in 12 countries. A total of 42 patients were screened between December 2007 and September 2008.|"18 of the 42 screened patients were not included in the study. The reasons were the following:
~Inclusion/Exclusion criteria not respected (16 patients),
~Subject's request (1 patient),
~Other (2 patients).
~Patients could have several reasons for not being included."
751674|NCT00576758||
751675|NCT00576732||
751676|NCT00576693||
751677|NCT00576680||
751678|NCT00576628|A total of 133 eligible participants were enrolled in the study conducted from 8 May 2008 to 31 March 2010 across 19 centers in Russia.|Out of total 133 enrolled participants who met the eligibility criteria, eight participants did not receive active study drug and were not included in any analysis population.
751679|NCT00576576|27 subjects enrolled and followed up for 6 months All subjects were recruited between 2007 and 2009 at Emory University Hospital|
751680|NCT00576524|The study recruited subjects from September 2007 to February 2011. The study will be performed in the Dialysis Unit of the Division of Nephrology, Department of Pediatrics at the Children's Hospital of Philadelphia (CHOP) with informed consent.|"The study design will consist of a run-in phase, followed by a randomized, cross-over, clinical intervention phase with application of the ITD (sham or -7 cm H2O) in 20 pediatric subjects undergoing regular hemodialysis."
751681|NCT00576472|505 patients were enrolled from 3 institutions between January, 2000 and February, 2009. 91 siblings were enrolled as a control group.|Of 505 patients enrolled on the study, 36 were never assessed, and 469 participated in the initial screening. Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day MPH In-Lab Phase.
751682|NCT00576420|Participants were enrolled at 12 clinical sites in the United States, beginning December 2007. The last participant completed the study in December 2008|101 participants were enrolled and screened. 26 were screen failures; 1 was excluded due to study issue; and 1 was withdrawn by investigator. Therefore, 73 of the 101 enrolled were randomized and treated.
751683|NCT00576407||
751684|NCT00576381|All subjects were recruited from inpatient cardiac intensive care unit prior to open heart surgery.|
751685|NCT00576316|201 patients were recruited from 10 government hospital based outpatient clinics from Dec 2007 until May 2008|
751686|NCT00576303|A total of 241 participants were recruited across 19 centers in Russia. The study was conducted from 29 Apr 2008 to 09 Jun 2010.|Of the 241 screened participants, 200 participants received the study drug and 41 participants were early withdrawals during the stability verification period (SVP)
751687|NCT00576251|20 enrolling sites (private ophthalmology clinical offices) with first subject enrolled 10/29/07 and last subject enrolled 2/14/08)|Parallel, 1:1 ratio; double-masked
751688|NCT00576199||The Participant Flow data are discontinuations from bevacizumab treatment. Data for discontinuations from the study are not available.
751689|NCT00576147|Near-Infrared examinations performed on all patients within 30 minutes before the CT scan of the head and within 12 hours of their head injury|
751690|NCT00576056||
751691|NCT00575965|Outpatient Clinic at Dana Farber Cancer Institute|Patients with progressive nonsymptomatic disease on watch and wait were enrolled.
751692|NCT00575887||
751693|NCT00575666|Subjects were recruited from the Freedom Trail Clinic at the Erich Lindemann Mental Health Center and were studied at the Massachusetts General Hospital Clinical Research Center (MGH CRC), Boston.|After providing written informed consent, subjects underwent a diagnostic evaluation by a research psychiatrist using the Structured Clinical Interview for DSM-IV (SCID). All subjects were screened and enrolled based on eligibility criteria. Baseline study assessments were completed prior to intervention.
751694|NCT00575588||891 participants were enrolled in the study; 33 participants did not enter the treatment period; 858 participants were randomized and treated.
751695|NCT00575510|Face-to-face recruitment of women 18-55 years of age occurred in 6 University of Texas Medical Branch (UTMB) Regional and Maternal Child Health Program clinics from June 1, 2006-November 30, 2010. Recruitment was interrupted for a period ranging from 2 weeks to 6 months in several clinic sites due to landfall of hurricane Ike on September 13, 2008.|6,179 women were eligible during the recruitment period. Of these, 876 declined participation, 4,671 had a normal Pap test result, 254 did not have a Pap test performed at their clinic visit, and 378 had an abnormal Pap test result and could be randomized. Of these, 90% (341/378)were randomized into the 3-arm trial.
751696|NCT00575380||
751697|NCT00575367||
751698|NCT00575328|Female subjects with remitted bipolar disorder and sexual dysfunction associated with their bipolar medication treatment regimens were recruited from 2/26/2008 to 4/26/2010, all at the Massachusetts General Hospital Depression Clinical and Research Program.|Subjects underwent a screening visit to determine eligibility. Those subjects deemed eligible returned a week later for a baseline visit, where eligibility was confirmed prior to treatment assignment. Subjects who for any reason no longer met entry criteria were discontinued and offered alternative treatment options.
751699|NCT00575185|University of Minnesota students that contracted Mono and wsere seen at the student health center|
751700|NCT00575159|A total of 10 participants with type 1 diabetes mellitus (T1DM) were randomized in this study. Study was conducted between 31 Mach 2008 to 19 January 2009 at a single center in the United States (US).|Participants were screened within 28 days of the first dose and a total of 10 participants were randomized to receive the study drug. The participants were admitted on Day -2 and were analyzed of all Baseline safety and glucose control on Day -1.
751701|NCT00575146||
751702|NCT00575094|Subjects were recruited in Japan from November 2007 to February 2008.|Subjects were screened up to 24 hours.
751703|NCT00575042|Patients were recruited from the liver clinics at University of Florida and Mayo Clinic Rochester.|
751704|NCT00575029|Recruitment 4/04 to 7/04.|
751705|NCT00575016||Of the 74 patients enrolled into the study, 73 patients received study medication and are included in the analyses. One patient was enrolled but did not receive study medication.
751706|NCT00574990||
751707|NCT00574951|The study was activated on 12/10/2007 and closed to accrual on 4/22/2008.|
751708|NCT00574912|12 individuals will be their own controls completing 5 separate 24 hour protocol studies. If a participant does not complete all protocols, another person will be recruited to complete the protocols until there are 12 completed studies in each arm/group.|
751709|NCT00574873||
751710|NCT00574847|We screened all patients with Coronary Heart Disease (CHD) who visited Duke cardiology clinics. Patients 21 years or older were eligible to participate if they had CHD, as documented by angiographic findings of coronary artery stenosis of 70% or greater, history of MI, or history of cardiac revascularization.|25527 underwent initial screening. 22833 excluded due to reasons including no CHD, atrial fibrillation/arrhythmia, psychiatric disorder, and LVEF less than 30%. 2294 did not provide consent. 65 excluded due to medical conditions. 203 excluded due to no MSIMI or inability to undergo mental stress testing. 5 more declined to undergo randomization.
751711|NCT00574834|Individuals with pre-diabetes (metabolic syndrome) are recruited for a 6 month study intervention.|
751712|NCT00574795|Participants were recruited in Japan from September 2007 to February 2008.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
751713|NCT00574704||
751714|NCT00574587|Dates of recruitment: April 2008 - September 2013|Patients with HER2 positive disease also received trastuzumab.
751715|NCT00574548||
751716|NCT00574405|104 children with T1D were screened between 04/05-02/09; 64 declined to participate; 16 did not meet inclusion/exclusion criteria. 24 subjects (12 per group) were enrolled. 1 subject in each group withdrew after initial randomization. Of the remaining 22, 1 completed the 9-mo visit, 1 completed the 6-mo visit, and 1 completed the 1-mo visit.|One subject in each group withdrew from further participation after initial randomization, possibly because of dissatisfaction with the assigned mode of treatment.
751717|NCT00574340|Individuals were recruited to participate in a cross-over design coming in for a 2 day study with an 8 week wash out period and then returning for another 2 day study. Individuals were randomized in the order of completing the control group (day 1 euglycemia, day 2 hypoglycemia) or antecedent hypo group (day 1 hypoglycemia, day 2 hypoglycemia).|All participants completed both studies (either the control study (day 1 euglycemia, day 2 hypoglycemia) or the antecedent hypoglycemia study (day 1 hypoglycemia, day 2 hypoglycemia) in a random order with each study separated by an 8 week wash out period.
751718|NCT00574288||
751719|NCT00574275|Between December 2007 and September 2009, a total of 546 participants were randomized in the study: 275 to the placebo group and 271 to the aflibercept group. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.|
751720|NCT00574249||
751721|NCT00574236|This study enrolled subjects with metastatic breast cancer from the Wisconsin Oncology Network (WON), which is driven by investigators at the University of Wisconsin Carbone Cancer Center, from August of 2006 through February of 2008.|
751722|NCT00574197||
751723|NCT00574171||
751724|NCT00574145|This study enrolled February 2007 to March 2009.|Forty-four patients signed consent, all were eligible.
751725|NCT00574119||
751726|NCT00574080|Participants are myeloma patients who have already received one or more treatment regimens and are seen at our facility|
751727|NCT00574067||
751728|NCT00573989||
751909|NCT00564876|Due to poor enrollment, this trial was closed to accrual and thus no results came from this trial.|
751729|NCT00573937|Patients were recruited from the outpatient hematology/oncology clinic, inpatient cancer service, and palliative care unit, at a tertiary medical center from September 2007 to April 2009.|One subjects was assigned to standard control treatment. No subjects received the experimental treatment. No subject data were analyzed.
751730|NCT00573872||
751731|NCT00573859||
751732|NCT00573833||
751733|NCT00573794||A total of 592 subjects were randomized and received at least 1 dose of study drug (safety population); 7 subjects enrolled at 3 noncompliant sites were excluded from the analyses (Intent-to-treat 1 [ITT-1] population; N=585).
751734|NCT00573768|Recruitment start 27 Nov 2007 Recruitment end 26 Jun 2007 Private Practices|
751735|NCT00573755|Four (4) participants were recruited at Mayo Clinic between January 2008 and August 2008. This trial was terminated early due to lack of participant accrual.|
751736|NCT00573534|Subjects were recruited from March 2008 until January 2010 from parents with adolescent children in adolescent substance use treatment center and with parents of children with ADHD whether there were older children who might have substance use problems. Community pediatricians and child psychiatrists supplemented this approach.|This was an open-label study, hence no group assignment. Thirteen families were offered study participation, 8 accepted. The five families that declined participation cited the impracticality of weekly visits and/or the adolescent's oppositional behavior as primary reasons for nonparticipation.
751737|NCT00573508||
751738|NCT00573469|"First participant enrolled on 16 October 2006. Last participant completed on 4 March 2008.
~Out of 90 screened participants, 77 participants (target was 75) were enrolled and included in Full Analysis set and safety analysis set. The numbers of participants in each set were 26 in D9421-C 9 mg, 25 in D9421-C 15 mg and 26 in Placebo, respectively."|Patients who had a CDAI score of less than 200 were excluded before randomisation.
751739|NCT00573443|Subjects diagnosed with pseudobulbar affect (PBA) secondary to amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).|
751740|NCT00573430|155 enrolled, 27 screening failure, 128 randomized. Eligibility criteria not fulfilled meant subjects who were not fulfilled at Visit 1 or Enrolment, but screening failure subjects were who fulfilled at Visit 1, but not at Visit 2 after screening period.|Total 128 patient enrolled, but among of them, 9 subjects excluded from analysis because of Withdrawal by Subject, Protocol violation, Eligibility criteria not fullfiled. You can see these number in above table. This analysis was conducted based on Intend to treat. Therefore, total analyzed number is 119, and 39, 44, 36 per arm respectively.
751741|NCT00573391||
751742|NCT00573313|Subjects were recruited between July 1, 2005 and June 30, 2009 through the emergency room and clinics of the University of California Davis Health System.|Three (3) participants with alcoholic liver disease dropped out before randomization. Participants (128) excluded because did not meet recruitment criteria, (105) because had not telephone or other means of contact, or (24) declined to participate.
751743|NCT00573287|Recruitment was conducted through Dartmouth Hitchcock Medical Center, the state psychiatric hospital, local community mental health centers and mailing to schools and primary care providers.|
751744|NCT00573261|Subjects were recruited from the outpatient endocrine clinics of a tertiary academic center and locally via advertisement between March 3, 2006 and April 1, 2008.|There were 4 subjects who provided study consent but did not complete the baseline assessment because of unwillingness to wear the LifeShirt monitor (n=2 in placebo arm) and inability of keeping baseline assessment appointment due to job reassignment (n=2 in pregabalin arm).
751745|NCT00573248||
751746|NCT00573183||
751747|NCT00573170|Results for the TRX109011 (NCT00573170) and TRX109013 (NCT00599157) studies were pooled for analysis. Individual studies were not analyzed or reported separately. The individual protocols were amended while ongoing to allow for pooling of study data for analysis.|"Randomized participants were treated for three separate migraine attacks with three different investigational products, assigned in randomized order, as one of six possible treatment sequences. Not all participants enrolled in the study were randomized for treatment; those participants who were randomized are said to have started the study"
751748|NCT00573157||
751749|NCT00573144|Subjects were recruited at the Mayo Clinic Cardiac Care Units in Rochester, Minnesota and Jacksonville, Florida.|One subject withdrew consent before randomization.
751750|NCT00573131|Patients were enrolled from 21 Jan 2008 through 05 Nov 2010 at 20 centers in 5 countries (United States, India, Poland, Czech Republic and Belgium).|
751751|NCT00573066|Recruitment occurred in the CHOP cardiac center during preoperative evaluation.|All patients were evaluated postoperative to establish appropriateness for inclusion in the study.
751752|NCT00572936||One patient who was taking latanoprost for ocular hypertension did not have an IOP rise greater than 20mmHg after discontinuing treatment for up to 12 weeks. A second patient who initially expressed interest chose to withdraw from the study.
751753|NCT00572910||
751754|NCT00572897|Patients were recruited from 2007 to 2011 at 11 centers affiliated with the Myeloproliferative Disorders Research Consortium (MPD-RC)|
751755|NCT00572832|Two hundred young women from the university community who met the eligibility criteria were recruited at the Student Health Service.|
751756|NCT00572728||
751757|NCT00572624|Gastric bypass surgery participants were recruited from the Barnes-Jewish Hospital bariatric surgery center. Diet and exercise participants were recruited from the Volunteer for Health office of Washington University School of Medicine.|
751758|NCT00572572||
751759|NCT00572533||
751760|NCT00572468||
751761|NCT00572260|Between 1/17/2008 and 9/15/2008, 124 subjects were identified as qualifying, 56 were referred and approached, 44 refused to participate, and 12 signed the ICF at Duke University Hospital inpatient care units.|Between 1/17/2008 and 9/15/2008, among the 12 study subjects that signed the ICF, 11 subjects met the eligibility criteria and were enrolled in the study. One subject was disqualified due to weight > 150kg and was withdrawn from the study
751762|NCT00572234|Dates of recruitment: August 31, 2007 - April 6, 2010 Recruitment from residential substance use disorder treatment programs in Omaha and Lincoln, Nebraska.|Initially participants were assigned to one of two randomization pools: one group with and one group without psychoses. However as of January 30, 2009 no participants met criteria for randomization to the psychosis arm of the study and the protocol was changed to remove the psychosis randomization pool.
751764|NCT00572156|Date of first enrolment: December 2007. Date of last completed: March 2012. This was a Phase II, multicenter, randomized, open-label, parallel-group, active treatment controlled, dose selection study conducted at 27 centers in the US.|Study screened 155 subjects. Due to failure in screening 49 subjects were excluded from the trial before assignment to groups.
751765|NCT00572117||
751766|NCT00572039||
751767|NCT00571987|The first subject was consented to the study in September 2004. The final subject was consented in March 2010. A total of 107 subjects were consented.|As part of this non-blinded and non-randomized study all participants receive ablation.
751768|NCT00571974|Subjects were identified in the head and neck oncology clinic and enrolled into the study within the time period of January 1, 2007 to November 18, 2009.|Screen failure did meet incl./excl. criteria
751769|NCT00571961|HIV negative subjects currently enrolled in a long-term buprenorphine maintenance therapy program for at least 3 months who have been on stable dose of buprenorphine/naloxone (BUP/NLX) for at least 3 weeks will be admitted to the General Clinical Research Center (GCRC) for pharmacokinetic (PK) blood draws at intervals over a 24-hour period.|Once admitted to the GCRC, subjects were maintained on 16 mg of BUP/NLX daily, except for 1 patient on 24 mg. As baseline, subjects on steady-state BUP/NLX were hospitalized and underwent pharmacokinetic investigation over a 24-hr period. Subjects served as their own controls.
751770|NCT00571948|Mothers were first contacted in the hospital 1-3 days after delivery. Of 832 contacted families 132 agreed to participate in the study up to the baby's age of 8 weeks.|All of the 132 participants were randomly assigned to one of the two study groups.
751771|NCT00571922||
751772|NCT00571701|Patients were recruited from 7 participating sites throughout the U.S. (locations in NY, VA, SD, AL, CA, IA and TN) that had investigators experienced in the treatment of this disease.|Patients initially entered a 6 month pre-treatment observation period prior to randomization into the 2 treatment arms. 9 subjects did not start the treatment period and are therefore not included in demographics or the results sections.
751773|NCT00571688|Referred by treating provider|Diagnostic review prior to randomization
751774|NCT00571662|Between November 2001 and February 2007 sixty eight patients were treated on this protocol and have been included in the analysis|
751775|NCT00571649|First patient first visit date: 04 DEC 2007; last patient last visit date 24 NOV 2010. Primary completion date: 12 AUG 2010. Participants were aged ≥40 years, hospitalized for an acute medical illness, and at risk of Venous Thromboembolism (VTE) (with heart failure, cancer, ischemic stroke, infection or inflammation, or respiratory insufficiency)|A total of 8428 participants were screened; 327 failed. 8101 were randomized. 7998 (98.7%) were in the Safety Analysis Set (SAF), i.e. received study medication. 6024 (74.4%) were in the modified Intent to Treat (at Day 35) group (valid for SAF with adequate assessment of venous thromboembolism). A total of 6005 (74.1%) completed study.
751776|NCT00571493|Subjects were screened and enrolled at an academic medical center in the United States.|
751777|NCT00571428||
751778|NCT00571324|Subjects with confirmed genetic and clinical diagnosis of Adenosine triphosphate (ATP)-sensitive potassium channels (KATP) hyperinsulinism were recruited from the Hyperinsulinism Center at the Children's Hospital of Philadelphia|
751779|NCT00571194||
751780|NCT00571103|Subjects were recruited through newspaper advertising, word of mouth, and lab registries. Subjects were seen in each doctor's clinic respectively.|Two subjects failed to meet study criteria (their severity of gambling was too low)and 6 subjects were lost to follow-up after the screening visit (Visit One).
751781|NCT00571064||
751782|NCT00571038|We wrote letters to posts located within 60 miles of the study hospital and followed up with a phone call to arrange for an in-person presentation. Before and after the presentation, we measured blood pressures and asked about diagnoses of hypertension. We scheduled individual appointments with potential subjects to confirm eligibility and consent.|Posts had to identify two potential peer leaders to be eligible for the trial. The post membership voted on whether to participate, even though many would not be followed as study members. All enrollment activities occurred before posts were assigned to an intervention. All participants within a post received the assigned intervention.
751783|NCT00570960|Hospitalized cirrhosis patients with SBP between September 2007 and July 2009|
751784|NCT00570921|Patients were recruited at a single location, University of Kentucky Markey Cancer Center, between March 2008 and October 2012.|
751785|NCT00570908||
751786|NCT00570778||This was 4 arm crossover study. There was a 7 day washout period between each treatment period. 154 patients were randomized, 153 participants received study drug. 5 patients were excluded from the Modified Intent-to-treat population (MITT). 4 patients for protocol violations and 1 patient was randomized but did not receive study drug.
751787|NCT00570765|Recruitment started Dec. 2007 and completed June 2010. Due to positive Phase 2 data in another study (747-202), power calculations were revised and recruitment ended early.|Screening interim allowed for pre-randomization eligibility assessment of 1 to 4 weeks. Other than 3-month (pre-Screening) washout for ursodeoxycholic acid (UDCA) and other medications, no washout or run-in period was defined between Screening and randomization.
751788|NCT00570739|Two cohorts of participants, type 2 diabetics (T2DM) and pre-diabetics, were recruited from 07 Jan 2008 to 15 Dec 2008. The sites were located in Colombia, India, Mexico, and the USA. The sites included private physician offices, group practices, clinics, hospitals, institutes, and university centers.|"Due to the different metabolic nature of the two groups the Total column under Baseline Characteristics is populated with data for the diabetic group, except where the total could be obtained by just adding the number of participants. Please note: in the outcomes section, LOCF=Last Observation carried forward"
751789|NCT00570713|Participants were recruited from a population of pancreatic cancer patients treated at investigational centers.|
751790|NCT00570700||
751791|NCT00570687|"This single-center study was conducted at:
~Profil Institut fur Stoffwechselforschung GmbH Hellersbergstrasse 9 D-41460 Neuss, Germany Principal Investigator: Dr. Klaus Rave
~First subjects first visit: 20 September 2007 Last subject last visit: 30 January 2009"|This randomized, open-label crossover study was conducted in 2 phases: original protocol (TI 45 U, Exubera 4mg and Lispro 12 U) and amendment 1 (TI 60U or TI 90 U, and Lispro 10 U). Both original protocol and amendment 1 had screening visits, meal challenge and glucose clamp visits (with a blood-loss recovery period between them) and final visits.
751794|NCT00570505||155 Subjects were enrolled per protocol (defined as signing the informed consent). After enrollment, 4 subjects withdrew consent prior to treatment, and 2 subjects were not implanted due to ineligibility discovered during screening. This resulted in 149 subjects starting the study and receiving treatment with the LAP-BAND System.
751795|NCT00570492||After screening and a 16-week Baseline Period (Pd.), participants (par.) were randomized 1:1 to each treatment arm during the 52-week Treatment Pd. After the Treatment Pd., par. entered an 8-week Follow-up (FU) Pd. during which all par. received placebo nasal spray. Par. completing at least 12 weeks of treatment were to complete the FU Pd.
751796|NCT00570401||
751797|NCT00570362|Patients with normal tension glaucoma attending the glaucoma clinic of the Catholic Eye Center at the St. Mary' Hospital (Seoul, Korea) between June 2008 and October 2008, were recruited for this study. The control group was recruited from other age-gender-matched volunteers.|Only subjects who voluntarily wanted to participate in this study were recruited.
751798|NCT00570349||
751799|NCT00570323||
751800|NCT00570310|"Last Patient Entered: 06-Dec-07
~Last Patient Last Visit: 11-Sep-08
~# Sites: 20 sites randomized at least 1 patient.
~21 sites screened at least 1 patient"|All patients were titrated up to the maximum tolerated dose of active treatment (pregabalin) over approximately 12 days. Patient were treated at the maximum tolerated dose until randomization at which time patient were either continued on active treatment or withdrawn from active treatment (i.e. placebo) in a double-blind fashion.
751801|NCT00570258||
751802|NCT00570232||
751803|NCT00570141||
751804|NCT00570089|20 subjects were recruited at Cedars-Sinai Medical Center Cardiology outpatient clinic.|This is a cross-over study. 20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
751805|NCT00570063||
751806|NCT00570037|October 2007 through February 2008 Post partum units of two Durham, North Carolina hospitals|
751807|NCT00569946||
751808|NCT00569868||
751809|NCT00569855|The patient population eligible for enrollment included those pediatric patients 20 kilograms or less in weight undergoing open-heart surgery requiring extracorporeal circulation (cardiopulmonary bypass) at Arkansas Children's Hospital, regardless of their gender or ethnic background|
751810|NCT00569803||153 participants were enrolled, with 106 discontinuing prior to study drug administration because they no longer met study criteria or they withdrew consent. 47 participants met all eligibility criteria and received study medication. 1 subject, who received an incomplete dose due to an injection syringe leak, was replaced.
751811|NCT00569777||
751812|NCT00569673||
751813|NCT00569660|Recruitment Period 6/7/05 to 4/4/08. All patients registered at The University of Texas M.D. Anderson Cancer Center.|The maximum accrual of 34 was met.
751814|NCT00569582|24 week multicenter, open-label trial after failed multimodality therapy at 14 U.S. academic medical centers and three private research centers.|Adults with endogenous Cushing's Syndrome associated with either type 2 diabetes mellitus/impaired glucose tolerance or a diagnosis of hypertension.
751815|NCT00569530||
751816|NCT00569374||
751817|NCT00569309||
751818|NCT00569270|Patients with COPD (chronic obstructive pulmonary disease), GOLD (Global Initiative for Chronic Obstructive Lung Disease)Stage 2 were recruited from pulmonary out-patient offices at Mt. Sinai Hosp. Toronto and from Arthur F Gelb MD Lakewood, Calif from June 2009 thru January 2010|We recruited 30 patients with smoking history >20 pack yr with documented GOLD Stage 2 moderate COPD who were clinically stable for at least 6 weeks prior to the present study and were not on oxygen or oral corticosteroids.
751819|NCT00569231|Patients for this study were recruited during the period between February 2007 and May 2009 from the outpatient Dermatology Clinic.|
751820|NCT00569192||
751821|NCT00569166|One-hundred and five (105) participants were recruited at Mayo Clinic Rochester between 3/08/2007 and 12/8/2009. There were 13 cancelled participants and were excluded from baseline characteristics table.|Participants were evaluated by telephone, or in person, according to the eligibility criteria and educated about the requirements of the study. Eligible and willing women were registered onto the study.
751822|NCT00569127||
751823|NCT00569010|Recruitment Period 12/28/2005 to 8/25/2008. All participants were registered at The University of Texas M.D. Anderson Cancer Center.|Of the 36 enrolled, only 34 evaluable participants were included in this study and started study drug.
751824|NCT00568958|Recruitment occurred primarily through Facebook advertisements and fliers. Following initial screening by phone or online surveys, individuals were invited for intake conducted by the research assistant at an outpatient university research clinic where written informed consent was obtained.|
751825|NCT00568854||
751826|NCT00568802||Data are presented for all participants because data relating to arm assignment are no longer accessible; the Principal Investigator (PI) has left institution and all efforts to locate the data have been exhausted.
751827|NCT00568776||
751828|NCT00568698||Data are presented for all participants because data relating to arm assignment are no longer accessible; the Principal Investigator (PI) has left institution and all efforts to locate the data have been exhausted.
751829|NCT00568685||
751830|NCT00568633||
751831|NCT00568555|325 women completed an online web survey|"Individuals were assessed for eligibility via web screening and phone screening prior to enrollment.
~Further eligibility (blood tests, questionnaires) assessed after enrollment; ineligible consented participants were withdrawn prior to assignment to groups."
751832|NCT00568451|Twelve (12) participants with un-resectable stage IV malignant melanoma were enrolled in the study between June 2006 and November 2008 at Mayo Clinic Rochester.|One patient canceled participation in the trial prior to starting Temozolomide therapy. This patient was excluded from all analysis.
751867|NCT00566930|chripractic clinic|117 participants were initially recruited. Following the initial clinical assessment, 98 met all inclusion criteria and were assigned to one of the three groups. 19 participants were excluded because they did not met all inclusion criteria (most common reason was that their neck pain could not be diagnosed as a common non specific neck pain).
751833|NCT00568399|Patients treated with chronic hemodialysis for ESRD at 2 Washington University units were recruited to undergo a battery of cardiovascular tests including CT quantitation (MDCT) of vascular calcification and possible treatment with sodium thiosulfate (see Am J Nephrol 2011;33:131-138)|All patients with a coronary artery calcium score of greater than 50 Angstrom scores were begun on treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.
751834|NCT00568386|Medical Clinic Nov. 2007|24 hr. wash out between treatment periods
751835|NCT00568334||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
751836|NCT00568178|"As of March 2011, the study was completed.
~Phase III First Patient In: 21Jun07; Last Patient Last Visit (double-blind base study): 16Sep08; and (open-label extension): 31Mar11. The study included 52 centers (USA, Europe, Latin America, and Asia) and participants included children aged 6-17 (hypertensive) or 1-17 (normotensive) with proteinuria."|During a 4-week, single-blind run-in participants received losartan placebo (normotensive) or amlodipine (hypertensive) and underwent wash-out of anti-hypertensive agents. To qualify for randomization, participants had to have a mean urine Pr/Cr ratio of ≥0.3 gram/gram (gm/gm) derived from baseline urine samples.
751837|NCT00568126|This study screened 57 and included 45 remitted depressed female outpatients aged 18-65. The patients were recruited from December of 2007 through June of 2010 through the Depression Clinical and Research Program in Boston, MA.|Patients were excluded if: diagnosed with a past sexual disorder, currently receiving other treatment for sexual dysfunction, experiencing sexual dysfunction due to underlying medical condition, had recent relationship changes or turmoil unrelated to the sexual dysfunction, or other health or social problems that might influence sexual dysfunction.
751838|NCT00568087||
751839|NCT00568061|7 medical centers enrolled subjects. A total of 29 subjects were enrolled in the study.|
751840|NCT00568022|Participants were recruited from 4 sites in Japan.|
751841|NCT00567996||1002 participants were randomized. 3 randomized participants in the Indacaterol group and 1 randomized participant in the Salmeterol group did not receive study medication and were not included in the intent-to-treat milestone.
751842|NCT00567892|Enrollment period: August, 2008 to June, 2010|Screen failure reasons included: Screening for clinical depression or other significant psychiatric conditions, history of significant head injury, inability to obtain motor threshold with repetitive transcranial magnetic stimulation (rTMS), MRI claustrophobia, and two patients elected not to participate.
751843|NCT00567879|Eligible participants were allocated to dose escalation arm 1 (i.v. panobinostat) or arm 2 (oral panobinostat) according to a pre-determined sequence in the ratio 1:1. Each cohort consisted of newly enrolled participants. This study included a dose escalation phase to establish the maximum tolerated dose (MTD) and a dose expansion phase.|
751844|NCT00567840||
751845|NCT00567593||
751846|NCT00567567||
751847|NCT00567541||
751848|NCT00567502|Participants who were newly diagnosed (received no treatment at the time of study registration) or previously diagnosed with essential thrombocythemia (ET), receiving or continuing previous cytoreductive therapy were recruited in the study|Due to the non-interventional nature of the study, participants could be receiving XAGRID, XAGRID+Other (Cytoreductives), other (cytoreductives) and no essential thrombocythemia (ET) therapy. During the study participants could change the treatments.
751849|NCT00567489|The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.|
751850|NCT00567476||
751851|NCT00567398|The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.|
751852|NCT00567359||
751853|NCT00567320||
751854|NCT00567307||
751855|NCT00567268||
751856|NCT00567255||
751857|NCT00567242|Subjects were recruited from December 2006 through August 2009. Fourteen subjects with minimally nonfluent aphasia, anomia, and at least some degree of frontal lesion participated in the study.|Prior to trial assignment, subjects underwent a functional MRI scan to determine degree of lateralization of frontal activity during word generation. Subjects with a high degree of right frontal lateralization of activity were excluded. Further, patients whose naming scores indicated that they were no more than minimally anomic were excluded.
751858|NCT00567229||
751859|NCT00567190||A total of 1196 patients were screened for the study, of whom a total of 808 participants were randomized to one of the two treatment arms.
751860|NCT00567164|The date of first subject, first visit was 22 Oct 2007. The date of last subject, last visit was 11 Nov 2009.|A total of 2450 subjects were screened ; 563 failed screening. The remaining 1887 subjects were assigned to treatment. Of these, 1864 (98.8%) were in the Full Analysis Set (FAS), ie, study medication was dispensed to them and they had at least 1 post-baseline observation. A total of 1196 (63.4%) subjects completed the study.
751861|NCT00567112||
751862|NCT00567008|Thirty-seven treatment-seeking participants from the greater metropolitan Philadelphia area were randomized to participate in this trial.|
751863|NCT00566995||
751864|NCT00566982|This was a multicenter study conducted at 23 centers in Belgium, Denmark, Finland, and Sweden. First subject was screened on Nov. 26, 2007 and last subjected completed the study on June 26, 2009|
751865|NCT00566969||
751866|NCT00566943|Subjects were recruited at one surgical site in the US from approximately March 2006 through May 2008. One hundred one subjects were entered into the study.|Subjects were excluded from the study if their Body Mass Index was less than or equal to 35 or greater than or equal to 65. Subjects could not have a life expectancy of less than 12 months nor a known sensitivity to bovine material.
751868|NCT00566852||
752253|NCT00546754|"First patient in: MAY-04-2007
~Last patient out: APRIL-16-2009
~Total number of sites: 163 sites in Canada"|
751869|NCT00566813|Recruitment of adults ages 18-65 occurred from 10/22/2004 to 2/21/2006 when the 10th eligible participant was confirmed. Potential participants were recruited from physician referrals at University of Illinois (UIC) or private practice, from information posted on the UIC Transplant Division website, and from diabetes chat groups.|88 individuals completed phone screenings; 15 withdrew, 58 excluded mainly for high weight, kidney disease, high insulin use, lack of hypoglycemia unawareness, previous transplant. 36 enrolled to be screened for eligibility. Of the 36, 5 withdrew, 21 were excluded for not meeting eligibility requirements. Remaining 10 subjects received transplants.
751870|NCT00566735||
751871|NCT00566722|Patients who were previously treated with etanercept, methotrexate (MTX), or narrow-band ultraviolet-B (NB-UVB) and had a sub-optimal response were recruited for participation in the study.|Participants who were receiving more than 1 of the treatments (etanercept, MTX, NB-UVB) at the time of screening must have discontinued 1 therapy (e.g., MTX) at least 30 days before first dose of adalimumab and must have discontinued the other therapy (e.g., NB-UVB) during a specified time before first dose of adalimumab. See Detailed Description.
751872|NCT00566709||
751873|NCT00566696|There were 73 enrollments at St. Jude Children's Research Hospital between 12/2007 and 12/2013. Of the 73, 37 were non-patient donors who did not receive therapeutic intervention, and therefore, no outcome data was collected.|
751874|NCT00566631||
751875|NCT00566579|During December 2007 to March 2009, 103 subjects who had been documented as LSIL from cervical biopsy histopathology were recruited from three colposcopic clinics.|3 of them declined to participate in this study. Only 60 of these 100 cases had positive results for HPV testing. Among women who had positive HPV testing results, 29 were randomly allocated to receive cryotherapy and 31 were allocated to observation.
751876|NCT00566527|Pediatric participants from 9 to 12 months of age at the start of the study were recruited at 48 study centers in Finland, France, and Germany.|
751877|NCT00566501|This study was recruited at 179 centers in Asia, Europe, North America, Oceania, South Africa, and South America during the period of 14 December 2007 to 01 April 2010.|This study (E2020-G000-328) was a 12-month, open-label extension of study E2020-G000-326. Subjects who had received donepezil 10 mg IR or donepezil 23 mg IR during Study 326 were eligible for enrollment into this study.
751878|NCT00566462||
751879|NCT00566254||
751880|NCT00566228||
751881|NCT00566150|Subjects were recruited from 2005-2008 from New Haven, CT and surrounding areas.|
751882|NCT00566111||
751883|NCT00566098||There was one screen failure.
751884|NCT00566020||
751885|NCT00565916||
751886|NCT00565864||
751887|NCT00565851|At the beginning of the study participants could be randomized to chemotherapy. On August 29, 2011 randomization to chemotherapy ended and participants could only be randomized to surgery.|
751888|NCT00565812||A total of 5077 participants were screened in the study, out of which only 1457 participants were randomized.
751889|NCT00565773|Enrollment began in December 2007 and all study activities completed on July 1, 2017 Participants were enrolled from patients of Emory University Hospital and the Emory Clinic in Atlanta, Georgia.|
751890|NCT00565747|Overall recruitment period: October 2007 until August 2010. Patients were recruited at both public and private IVF clinics|Patients with informed consent but where it turned out that the inclusion/exclusion criteria were not fulfilled before assignment to groups, were excluded from the per-protocol (PP) analysis.
751891|NCT00565721|A total of 33 subjects enrolled in this study. 16 subjects completed the study and 17 subjects did not.|33 subjects enrolled,16 subjects completed and 17 did not complete. The reasons why 17 subjects that did not complete the study: 2 subjects failed screening, 6 subjects were lost to followup, 1 subject the procedure had technical problems, 2 subjects discontinued due to Physician decision, and 6 subjects had other reasons for not completing.
751892|NCT00565669||
751893|NCT00565643||
751894|NCT00565617||
751895|NCT00565604|Subjects who had the presence of incompetent perforator veins were recruited from a medical clinic.|Two subjects were withdrawn from the study immediately after the index procedure due to failure to treat any incompetent perforator veins.
751896|NCT00565461||
751897|NCT00565448|Participants were enrolled from November 2007 until October 2008. The study was conducted at 26 centers in 14 countries.|
751898|NCT00565409||
751899|NCT00565370||
751900|NCT00565266||
751901|NCT00565136|Subjects enrolled at 5 U.S. study centers (medical clinics) from September 2007 to August 2008. The maximum allowed enrollment number from one site is 12.|After signing informed consent and prior to implant, subjects completed a 3-week bowel diary to describe the FI episodes, Fecal Incontinence Quality of Life scale, Wexner Score, Symptom Severity Scale in Fecal Incontinence, pain intensity scale, and dynamic MRI or defecography.
751902|NCT00565110||
751903|NCT00565084|"First Patient Entered 16 Mar 2007
~Multicenter, 3 sites"|This study is a single dose, multi-center, randomized, placebo controlled, cross-over study using the Walking Model of Osteoarthritis (OA) knee pain. The efficacy and tolerability of a single dose of Ibuprofen 800 mg in the setting of standardized walks will be compared with placebo.
751904|NCT00565058|A total of 27 acute myeloid leukemia (AML) patients with either relapse (> 6 months) after First complete remission (CR1) or refractory/early relapse CR1 duration < 6 months were enrolled into the study from 6 sites. In total, 25 patients were treated with GTI-2040.|"Patients were enrolled in one of two treatment arms: Pilot Arm (Pilot PD Group) using delayed administration of GTI-2040, or a Phase 2 Arm (Phase II Group) using early administration of GTI-2040 with respect to High Dose Cytarabine (HiDAC)."
751905|NCT00565045||
751906|NCT00564954||
751907|NCT00564902|Subjects were patients in the Ophthalmology/Optometry Clinic North Chicago DVA Medical Center (now the James A. Lovell Federal Health Center)with early and moderate AMD retinopathy up to, but not including,high risk NEI AREDS retinopathy.|No enrolled participant was excluded before assignment to groups. Patients were asked to continue with their normal diet and were asked not to take any dietary supplement containing lutein (or zeaxanthin) beyond the 250 ug (1/4mg) commonly found in pabulum Centrum® type vitamins.
751908|NCT00564889|Thirty-five(35) participants were recruited between December 2007 and November 2008 at Mayo Clinic.|
751910|NCT00564850|62 participants were screened, of which 37 met the study's entry criteria and received at least one dose of investigational medicinal product. 25 participants failed screening. Participants were recruited from October 2007 at 18 Hospital clinics across France.|
751911|NCT00564733||
751912|NCT00564681||
751913|NCT00564629|Healthy Adult males at one site in the United States|Eligible subjects were given intravenous (IV) endotoxin 1 ng/kg as a test dose and observed for 1 hour. Next, subjects were administered a 4 ng/kg pyrogenic IV endotoxin dose and monitored until a core temperature of at least 38.6 ºC was reached. Subjects achieving a sufficient fever response were then randomly assigned to study treatments.
751914|NCT00564486|The study was conducted at 17 sites across the US from 27 Nov 2007 to 12 September 2008.|On the morning of Post Operative Day 1, the subject was to have a pain intensity (PI) categorical score of moderate or severe and a visual analog scale (VAS) >= 40 mm, but <= 70 mm at rest on a 100 mm VAS.
751915|NCT00564447|December 2007|Normal volunteers
751916|NCT00564395|Eighteen participants were recruited for this trial. However, only 14 participants completed both study visits. Subjects were recruited from the clinics through fliers and online postings|"One male subject dropped out because of a very active sports schedule and could not continue participation.
~Three subjects (two males and one female) had trouble with the Continuous Glucose Monitoring (CGM) tracing and, therefore, were excluded from the final analysis."
751917|NCT00564278|The recruitment period extended from June 3, 2008 to Aug 14, 2013. Advertising was placed in local newspapers recruiting Hispanic adults to the trial, which took place in the Hispanic Treatment Program at the Psychiatric Institute, a research and clinical institute in Upper Manhattan affiliated with Columbia University.|Of N=109 patients enrolled in SADT, 12 were pre-treatment drops (signed consent but did not return for a medication visit) and N=97 came to 1+ medication visit. Of N=108 patients enrolled in MADT, 10 were pre-treatment drops (signed consent but did not return for a medication visit) and N=98 participated in at least one medication visit.
751918|NCT00564265|Hospital patients operated on for Gastrointestinal stromal tumor (GIST)|The intention was to include all consecutive patients with GIST who presented during the study period. All consecutive patients with GIST were included during the study period
751919|NCT00564070||
751920|NCT00564018||
751921|NCT00563797||284 subjects were assessed for eligibility, but 263 were excluded because they did not meet inclusion criteria or did not want to participate.
751922|NCT00563784|The recruitment period: Nov 20, 2007 to June 18,2010. Total 68 stage IIIA/IIIB Non-Small Cell Lung Cancer (NSCLC) patients registered in the study. Eligible criteria: stage III NSCLC, inoperable, Karnofsky score ≥ 80, weight loss ≤5% in 3 months, forced expiratory volume in 1 second ≥ 1.0 L, and adequate hematologic, hepatic, and renal function.|There were 20 patients off-study after enrollment due to screen failure. Two patients were taken off protocol: 1 for diarrhea unrelated to treatment and the other for chemotherapy-induced chest pain. Only 46 patients are evaluable for this study.
751923|NCT00563706||A total of 204 participants were randomized, of which 202 participants received at least 1 dose of double-blind test article.
751924|NCT00563576|Participants were recruited from a Title X Family Planning Clinic in New York City.|Women seeking DMPA eligible to participate it 18 years old, English or Spanish speaking, had not used DMPA or Levonorgestrel intrauterine system in the preceeding 120 days. Women reporting oligomenorrheas (defined as fewer that 4 periods in the last 6 months), amenorrhea, or contraindications to either DMPA or estrogen were excluded.
751925|NCT00563381||There were 8 patients (4:4 on Tiotropium and Salmeterol respectively) randomized but not treated
751926|NCT00563368|Subject recruitment occurred at investigative sites in the US between November 2007 through January 2008|
751927|NCT00563316|This study was conducted at 6 sites in the United States and Canada. The first patient enrolled on 28 March 2008 and the last patient enrolled on 30 January 2009. Results are reported up until the data cut-off date of 16 July 2009.|
751928|NCT00563290||
751929|NCT00563186|Between June 2007 and February 2010 all patients admitted to the General Internal Medicine Service at Foothills Medical Centre from the emergency room, urgent assessment clinic or the community were assessed for eligibility into the study.|Exclusions: admitted from another health care facility or another hospital ward or to a non-study unit, required telemetry, < 18 years of age, or were preferentially admitted to the novel or the traditional design ward. Once pre-assigned, excluded if LOS <48 hours (Novel ward=97, Historic ward=74); or data incomplete (Novel ward=1; Historic ward=1)
751930|NCT00562965|Enrollment of participants started on 15 November 2007 and completed on 16 January 2009. The trial was terminated (07 April 2011) due to poor accrual of 29 out of 978 planned participants.|
751931|NCT00562861||
751932|NCT00562718||
751933|NCT00562627||
751934|NCT00562588|551 patients enrolled, 548 randomized, 543 treated; analysis is based on treated patients|
751935|NCT00562484||
751936|NCT00562354||271 participants were enrolled; 270 were vaccinated with study vaccine.
751937|NCT00562328|Thirty-three (33) participants were recruited at Mayo Clinic (Rochester and Arizona) between January 2008 and February 2010.|All patients were deemed eligible.
751938|NCT00562315|The study was completed November 28,2007 through July 10, 2012.|Of the 128 participants consented, 93 participants met the criteria to receive the ProstaScint (In-capromab pendetide) and the FACBC (anti-3-[18F]) scans. 115 participants had FACBC scans, with 13 receiving repeat scans. Therefore, excluding 13 participants. 93 participants had one FACBC scan and one ProstaScint scan and did not have repeat scans.
751939|NCT00562302||
751940|NCT00562159|A total of 439 participants were randomized at a total of 62 sites (53 sites from US; 9 sites from Canada) to treatment assignment, and 438 participants received at least one dose of study medication: 213 participants received SCH 697243 and 225 received placebo.|Thirty five participants from the observation year did not continue on to the treatment year; 14 participants were not eligible and 21 participants were screen failures.
751941|NCT00562120||
751942|NCT00562094||
751978|NCT00560417||Intention to Treat (ITT) Population consisted of all randomized participants who received at least one dose of study drug and had at least one post-baseline measurement.
752254|NCT00546728|Patients were recruited from medical clinics|
751943|NCT00561977|Of 78 patients responding to advertisements at UMass Medical School intranet, 36 (41%) eligible overweight and obese patients were consented to participate in the study. Dates of recruitment were May-August 2007.|23 ineligible, 5 refused screening, 12 patients put on waiting list, 2 patients dropped prior to randomization due to pregnancy. 2 patients added from waiting list to active participation.
751944|NCT00561951||Eligible subjects who underwent screening were enrolled into the run-in period at visit 1 and received single-blind placebo for 2 weeks. At Visit 2, Only subjects with overactive bladder who met the criteria were randomized to one of three treatment arms (fesoterodine 4 mg, fesoterodine 8 mg or placebo) in a 1:1:1 ratio.
751945|NCT00561925||
751946|NCT00561912|There were 2 patients registered to the trial between the dates 31 October 2007 and 29 July 2008.|The trial was terminated early due to slow accrual and unavailable treatment agent.
751947|NCT00561834||
751948|NCT00561821||
751949|NCT00561795|Enrollment was to occur in Arm B (Arm A6-1 or A6-2) if <2 subjects experienced dose-limiting toxicities (DLTs) while on Arm A5-1 or A5-2. After review of data (pre-specified in protocol) ≥2 subjects in Arms A5-1 and A5-2 experienced DLTs; the study was closed and no subjects were enrolled into Arm B. Three ongoing subjects were taken off regimen.|
751950|NCT00561730||
751951|NCT00561678|Trial was conducted at 10 sites from February 2008 to May 2014. The lead site was The Mount Sinai Hospital in New York City.|
751952|NCT00561652|Veterans were recruited between 1/2008 & 3/2009 at the Minneapolis VA, with flyers given to patients presenting to Primary Care, Physical Therapy & Orthopedics clinics with low back pain; recruitment posters; & mailings to patients previously diagnosed with back pain.|1075 were offered initial phone screening, 71 completed further in-clinic screening, & 30 were randomized. Participants were randomly assigned to treatment groups at the time of enrollment with no wash out, run-in, or transition between enrollment and group assignment. No enrolled participants were excluded from the trial before group assignment.
751953|NCT00561600|Recruitment at orthopaedic clinics began Nov 2006 and ended Dec 2009|
751954|NCT00561574||
751955|NCT00561470|Between 19 November 2007 and 16 March 2010, 614 participants were randomized to the placebo arm and 612 participants were randomized to the aflibercept arm.|
751956|NCT00561457|Subject enrollment was completed November 1, 2004 with a total of 134 patients from 9 study sites.|
751957|NCT00561431||
751958|NCT00561418||
751959|NCT00561392||
751960|NCT00561353|The study was conducted at 25 sites in 6 countries: Belgium, France, Germany, Poland, the Netherlands, and the United Kingdom.|A total of 121 participants infected with Hepatitis C virus (HCV) were randomized of whom 116 were treated. Reasons for not receiving treatment were withdrawal of consent (4 participants) and sponsor's decision (1 participant).
751961|NCT00561340|33 subjects total were eligible for participation in this study. 29 were enrolled and are included in the analysis. All patients had previously completed an 8-week double-blind placebo-controlled study of atomoxetine for the treatment of ADHD in 5 and 6 year olds.|25 subjects were randomized to one of the 2 treatment groups. An additional 4 subjects for whom randomization to caloric supplementation was inappropriate were included in the nutritional counseling only arm for purposes of analysis as they did enroll in this study.
751962|NCT00561145|Subjects will be recruited by publishing advertisements in local newspapers and by sending out general e-mails to an e-mail list of persons who had indicated their interest in participating in studies of our university|
751963|NCT00561080|A total of 779 participants were screened. Twenty participants were not randomized.|
751964|NCT00561015||Out of 26 participants infected with genotype 2 hepatitis C virus (HCV) who were randomly assigned to treatment, only 23 participants received treatment. 2 participants withdrew and 1 participant was infected with HCV genotype 4. All the 26 participants infected with genotype 3 HCV received treatment.
751965|NCT00561002|The study participants were enrolled from 29 October 2007 through 27 November 2007 at 1 US site.|A total of 34 participants who met the inclusion and exclusion criteria were enrolled, 2 were not vaccinated and excluded from the analysis.
751966|NCT00560950|This was a Phase III study. The first patient was enrolled (FPE) on 13-Jul-2007. The last patient last visit (LPLV) was on 30-May-2008. A total of 5 US study centers were involved in the recruitment.|Base trial 4/97-4/98 Prior to results posted Initial: subjects received 1st or 2nd dose of PN23 Persistence: followed immune response 5 yrs; ended 4/03 Extension 7/07-4/08: enrolled 9-10 yrs after base. 1dose of PN23 Blood drawn Days 1&30, immune response to 8 serotypes measured 143 of 400 enrolled: difficulty enrolling eligible/interested subjects
751967|NCT00560937|Patient recruitment occurred between 8-05 and 4-06 for this single-site study at the Durham VAMC, Durham, NC.|Following the screening visit, patients were withdrawn during the placebo lead-in phase and were not randomized for the following reasons: 1. hyponatremia, 2. hospitalization, 3.pneumonia, 4.no show for follow-up study visit, 5.chest pain, 6. elevated prolactin at baseline, 7.prolonged QTc at baseline
751968|NCT00560885|Treatment subjects were recruited from the routine clinical referral base of one or more surgeons at each investigational site.|Subjects were screened for enrollment and consented prior to being brought to the OR with the potential that they may not be eligible based on some criteria evaluated in OR (i.e. left atrial size assessed by TEE). 1 subject was found to have LA size that excluded them from the trial.
751969|NCT00560859|Children were recruited at 7 academic sleep centers. Early in the trial the investigator at one center relocated and that center was withdrawn.|
751970|NCT00560833||942 participants were randomly assigned to treatment in this study, however, one screened participant was given placebo treatment without a randomization assignment. This participant is included in the study placebo population.
751971|NCT00560794||
751972|NCT00560755|Healthy pediatric participants were enrolled at 84 study centers in 7 European countries.|
751973|NCT00560703|Recruitment time was approximately 6 months in 8 US clinics.|Subjects were screened for eligibility within 6 weeks prior to the baseline visit. This 12-week study employed a two-treatment, parallel-group design with subjects randomized in a 2:1 ratio to active drug or placebo.
751974|NCT00560612|Patient enrollment at the Durham VA Medical Center occurred from February 2006 until July 2008.|
751975|NCT00560573||
751976|NCT00560560||
751977|NCT00560508||
751979|NCT00560404|A total of 457 participants were enrolled across 24 centers in Brazil from period April 02, 2008 to July 02, 2009.|All participants received epoetin alpha during a four-week safety verification period. Of 457 participants, 233 eligible participants entered the treatment period.
751980|NCT00560391||Of 39 participants were enrolled in this study, 4 never received treatment due to screening failure. A total of 35 participants received treatment.
751981|NCT00560352||A total of 16 participants were enrolled, and 14 participants received treatment. The study was terminated due to an unexpectedly low recruitment rate, and no participants were enrolled in a planned dose-expansion phase.
751982|NCT00560313|Participants were enrolled at one site in Italy and one site in Germany.|Approximately 250 adults were planned to be enrolled in this study but only a total of 54 subjects were enrolled after the screening for the inclusion and exclusion criteria.
751983|NCT00560235|Participants were recruited separately for Phase 1 and Phase 2. A total of 138 participants were assigned to received study treatment (31 participants for Phase 1 and 107 participants for Phase 2).|
751984|NCT00560105|We recruited 45 subjects, of which 5 subjects either did not meet the initial inclusion/exclusion criteria (n=3) or did not meet the compliance criteria between the recruitment and randomization visit (n=2).|Of the 40 subjects who were randomized, 20 each were randomized to the 2 devices. Of these 40 subjects, 37 completed the study.
751985|NCT00560066|Subjects were enrolled at 17 centres in Germany.|All enrolled subjects were included in the trial.
751986|NCT00559988||
751987|NCT00559962|The study was performed from 06 Sept 2007 to 05 Sept 2008. A total of 16 medical clinics participated in the study.|Subjects underwent a 5- to 9-week screening washout period to determine study eligibility and to wash-out patients of all lipid-lowering therapies; patients were required to have low-density lipoprotein cholesterol (LDL-C) between 100 and 190 mg/dL (average of 2 visits during screening) and hepatic fat less than 6.2% for randomization.
751988|NCT00559949|Between December 11, 2007 and June 30, 2009, 39 patients were enrolled at 5 cancer centers in the United States and one cancer center in Canada.|
751989|NCT00559936|Participants were recruited from the Cornea Service at Massachusetts Eye and Ear Infirmary from February 2007 through October 2010.|Only patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.
751990|NCT00559897||
751991|NCT00559845||56 participants were enrolled in 8 centers in Italy.
751992|NCT00559754||
751993|NCT00559637||
751994|NCT00559585|During the double blind short term (ST) period of the Main study, a sub-study in RA participants was initiated to evaluate anti-tumor necrosis factor (TNF) failure population. The sub-study was terminated early due to slow recruitment and participants from the sub-study were allowed to roll into the Main study during the LT Open Label Period.|2492 enrolled: 2472 in Main Study:1008 not randomized: 918 no longer met criteria, 61 withdrew consent, 7 lost to follow-up, 22 other reasons. Randomized, not treated: 4 no longer met criteria, 2 withdrew consent, and 1 randomization error; 20 enrolled in Anti-TNF sub-study; 2 not randomized as no longer met criteria; 18 randomized in substudy.
751995|NCT00559507|Protocol Open to Accrual 10/25/2007 Primary Compeltion Date 02/22/2011 Recruitment Location is medical clinic|
751996|NCT00559468|Participants who had a surgical procedure using a general anesthesia (with sevoflurane or propofol) and rocuronium for endotracheal intubation and maintenance of neuromuscular block (NMB) were enrolled in this study.|Out of 52 randomized participants, 51 received treatment.
751997|NCT00559377||
751998|NCT00559364||Patients underwent screening phase (up to 10 days) and wash-out phase (6 to 7 days, where baseline coefficient of fat absorption [CFA] was determined) before entering randomization phase. Out of 218 patients, who entered screening and washout phases, 168 discontinued due to screen failure; 50 patients were randomized to treatment phase.
751999|NCT00559273||
752000|NCT00559104||
752001|NCT00559013|38 subjects were recruited from two principal investigators and their respective surgical hospitals in the US from approximately February 2007 through October 2008.|Subjects were excluded from the study if the met any of the exclusion criteria including having a a body mass index greater than 35, a history of Chron's Disease, or stage IV cancer. There was no washout, run-in or transition period to this study.
752002|NCT00558896|Between November 2007 and March 2012, 7 sequential phase 2 trials (reported as separate arms) were conducted. A total of 378 participants were recruited at Mayo Clinic (Arizona, Florida or Arizona).|One patient was deemed ineligible and excluded from all analyses.
752003|NCT00558870|Recruitment period: November 13, 2007 to August 26, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Study was halted early due to slow accrual. One participant of the five enrolled did not get randomized therefore did not receive treatment and is excluded.
752004|NCT00558844||
752005|NCT00558831|Participants in this study were patients clinically diagnosed with acne vulgaris. Participants will be recruited from the clinic. Patients were 18 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face.|
752006|NCT00558792|Patients were enrolled from December 2007 to December 2009 in 17 investigational sites across the United States of America (USA), 2 investigational sites in Canada and 2 investigational sites in Italy. A blinded read of the images obtained during the study was performed in May 2010.|This was a Phase II, multicenter, prospective, double-blind, randomized, parallel-group comparison of 3 doses of iopamidol injection 370 when used for coronary MDCTA.
752007|NCT00558753|From August 2006 to August 2007, 350 consecutive patients scheduled to undergo elective primary Total knee arthroplasty (TKA) were contacted and assessed for study eligibility. There were 110 Screen Failures (31 Not meeting inclusion criteria, 79 eligible but did not give consent), resulting in 240 enrolled subjects.|There were 110 Screen Failures (31 Not meeting inclusion criteria, 79 eligible but did not give consent), resulting in 240 enrolled subjects.
752008|NCT00558701||
752049|NCT00556543|10 Study subjects were enrolled to the study over a 10 month period in 2007 (February to November and underwent surgical repair of their rib fracture injury. All subjects were recruited from the OHSU Hospital and Outpatient Clinic.Study approval was granted on 11/18/2006 by the OHSU Research Integrity Office.|6 of the consented study participants had acute rib fractures, 4 had chronic rib fracture non-unions.
752050|NCT00556504|recruitment period: 12 Months location: CGMH clinical ceters|
752009|NCT00558636|Subjects were recruited from 23 Sep 2007 to 12 May 2008 (first subject's first visit to last subject's last visit) at 15 centers in 4 countries: China (9), Singapore (2), Thailand (2), and Taiwan (2). The study was terminated prematurely after about 5 months of recruitment and before the planned 230 progression free survival (PFS) events occurred.|At the time of study termination, 91 (out of 108 screened subjects) of the planned 294 subjects had been screened and randomized. All 91 randomized subjects received at least 1 dose of study drug and were included in both the intent-to-treat (ITT) and safety analysis populations.
752010|NCT00558571||
752011|NCT00558558|Recruitment Period: 10/22/07 to 07/24/08. All patients recruited at UT MD Anderson Cancer Center.|Of the six patients registered, two patients were ineligible and not included in any group assignment. Four patients were not eligible for analysis.
752012|NCT00558519||
752013|NCT00558467||
752014|NCT00558428||1487 were enrolled, 1098 entered but 1 patient not treated.
752015|NCT00558363||
752016|NCT00558285||
752017|NCT00558272|Randomised=full analysis set: AZD0530 175mg=69, Zoledronic acid 4mg=70; safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69|
752018|NCT00558259||There were 3 patients randomised to placebo who received Dabigatran only. For all analyses of efficacy, these patients are analysed as randomised. For all analyses of safety, these patients are analysed as treated.
752019|NCT00558246|Subjects were recruited from the genreal popluation of those undergoing elective, bilateral breast surgery.|
752020|NCT00558103|This study consisted of an initial randomized treatment phase; participants were randomized to receive lapatinib, pazopanib, or combination therapy. Participants who received pazopanib monotherapy in this initial phase and experienced disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.|Enrollment in Cohort 1 was halted after 76 participants had been randomized based on safety data from Study VEG20007 (NCT00347919). The protocol was amended (Amendment 2) to change the combination therapy dose (Cohort 2); in addition, an open-label pazopanib arm (pazopanib 800 milligrams) was added (Cohort 2).
752021|NCT00558064||
752022|NCT00558025||
752023|NCT00558012||
752024|NCT00557947|Subjects were recruited from the general population undergoing elective surgical procedures for body contouring.|
752025|NCT00557882||
752026|NCT00557856||
752027|NCT00557830|13 community oncology sites across the US associated with the ACORN network participated in this study. Enrollment started in January 2008 and was closed in August 2008 due to the low rate of accrual and lack of funds beyond the current level of support from Bayer.|Informed consent was obtained from all subjects. All subjects underwent a screening phase that could last up to 4 weeks during which pre-study assessments were completed. Eligible subjects then underwent a screening treatment phase in which they received commercial sorafenib for 4 weeks.
752028|NCT00557622||Prior to assignment to the 12-week treatment phase, all participants received placebo in a single-blind manner in a 4-week run-in phase. Participants completing the run-in phase were then randomized to receive either placebo or paroxetine for the remainder of the study. Two participants were withdrawn from the study before randomization.
752029|NCT00557505||
752030|NCT00557492||
752031|NCT00557466||
752032|NCT00557440||
752033|NCT00557362|From November 27, 2007 to May 12, 2008, all patients with a corneal ulcer presenting to Aravind Eye Hospital's cornea clinics in Madurai and Pondicherry, India, were evaluated for eligibility. The Aravind Eye Care System is both a primary and tertiary care eye hospital in South India with a well-established cornea subspecialty clinic.|All patients with a corneal ulcer had corneal scrapings using a Kimura spatula for Gram stain and potassium hydroxide wet mount and had cultures plated on blood, chocolate, and potato dextrose agar. If all inclusion criteria and no exclusion criteria were met, the patient was enrolled in the study.
752034|NCT00557349|Study participants were recruited from patients preparing for Roux-en-Y gastric bypass (RYGB) at Missouri Bariatric Services, the bariatric clinic associated with University of Missouri. Patients were recruited from November 2006 through November 2007.|While study participants were enrolled prior to their RYGB, they did not begin the study drug until after discharge from the hospital post-RYGB. During that time some patients were excluded, whether it was because the patient's surgery was cancelled or because the patient no longer met the inclusion/exclusion criteria.
752035|NCT00557323|Followed subjects from study SPD405-309 (NCT00150540) for 5 years.|
752036|NCT00557310||Participants who completed the 18 month main study had an option to continue treatment for an additional 6 months (Extension Phase).
752037|NCT00557284|The study was conducted at 2 outpatient clinics in the Denver, Colorado, metropolitan area between February 2008 and March 2009. Individual subject participation lasted for approximately 9 weeks.|Thirty-three subjects were screened for the trial; 20 subjects met all inclusion and exclusion criteria; 13 failed to meet all inclusion criteria.
752038|NCT00557245||
752039|NCT00557193|Infants with Acute Lymphoblastic Leukemia (ALL)|MLL-germline [G] to SR (Arm A/Group 1), MLL-rearranged [R] randomized/assigned to Arm B (Group2; chemo) or Arm C (Group3; chemo+lestaurtinib) with dose determined by age at dx (>=90 days is IR and <90 days is HR)
752040|NCT00557076|Subjects were recruited from a large urban community population and two acute rehabilitation hospitals. Community participants included patients not treated at the two acute rehabilitation hospitals. Acute rehabilitation programs included one U.S.|All patients with possible impairment in sound conduction were withdrawn prior to randomization. In total, 5 participants were withdrawn prior to randomization: 1 participant failed the auditory pathway screen, 2 participants recovered full consciousness, and 2 participants were placed in hospice by LAR. Therefore 16 participants were randomized.
752041|NCT00556998||
752042|NCT00556972||
752043|NCT00556946||
752044|NCT00556933||
752045|NCT00556894||
752046|NCT00556842||
752047|NCT00556712||
752048|NCT00556673||
752051|NCT00556491||
752052|NCT00556478||
752177|NCT00550550|A total of 345 subjects were randomized at a total of 68 sites (58 sites from United States; 10 sites from Canada) to treatment assignment, and 344 subjects received at least one dose of study medication.|
752053|NCT00556452|Patients with relapsed or refractory hematologic malignancies not in remission received unmanipulated HSCT with CloBu4 conditioning from October 2007 to November 2009 at the University of Michigan. Patients received a clofarabine dose of 20mg/m^2, 30 mg/m^2 or 40 mg/m^2.|
752054|NCT00556439|Participants with giant cell arteritis or Takayasu arteritis were recruited at 11 academic medical centers. For giant cell arteritis, the first participant was enrolled 2/2009 and the last participant was enrolled 1/2014. For Takayasu arteritis, the first participant was enrolled 2/2009 and the last participant was enrolled 11/2013.|
752055|NCT00556426|Eleven Investigators at 11 sites enrolled a total of 100 study subjects between December 7, 2005 and July 24, 2006.|
752056|NCT00556400||
752057|NCT00556374|The first patient was enrolled on 18 December 2006 and the last patient was enrolled on 22 July 2013. 5 patients randomized withdrew full consent and are not included in any analyses. Results data are reported as of 06 October 2014 (the date of last end of treatment visit).|Randomization was stratified by type of hospital (major academic centers or other centers), prior aromatase inhibitor usage (Yes/No) and total lumbar spine bone mineral density (BMD) score at baseline (T-score < -1.0 or ≥ -1.0).
752058|NCT00556322||
752059|NCT00556166||
752060|NCT00556140|Recruitment ran from Sept. 13, 2004 to Aug. 9, 2006 from the Massachusetts General Psychiatry Inpatient and Outpatient clinics.|All participants enrolled in the study were given aripiprazole and escitalopram.
752061|NCT00556075||
752062|NCT00556049||
752063|NCT00555997||
752064|NCT00555971|Patients seen for evaluation and management for suspected AERD|16 subjects signed consent but only 13 were randomized 2 were screen fails and 1 lost to follow up
752065|NCT00555906||
752066|NCT00555893||One participant in the 194 enrolled was negative for influenza by polymerase chain reaction at randomization and was therefore excluded leaving 193 individuals started in the study.
752067|NCT00555880||
752068|NCT00555750||
752069|NCT00555672||
752070|NCT00555620||
752071|NCT00555581||
752072|NCT00555568|Three cohorts of veterans were recruited from each of two sites. Those assigned to a peer-led group participated in the Vet-to-Vet program. Those assigned to a clinician-led group participated in a recovery-oriented group led by a clinician. Those assigned to 'treatment-as-usual' continued with their usual treatment.|
752073|NCT00555477|Subjects were recruited at the University of Michigan, the Dana-Farber Cancer Institute, and Johns Hopkins University from 2008 until 2010.|69 patients were enrolled however only 59 patients began treatment with anastrozole. Patients that were enrolled and found to have estradiol concentrations greater than 20 pg/ml were not treated.
752074|NCT00555464|Study participants were recruited from the Pediatric Dermatology clinic at Children's Hospital of Wisconsin between. Study enrollment period extended from 2008-2009.|Subjects meeting eligibility criteria including diagnosis and lesional size criteria were enrolled in the study. Subjects who had received topical or intralesional corticosteroids were eligible following a 1 week wash-out period.
752075|NCT00555438|patients have been included between june 2007 and june 2008 in public and private French hospitals|Nine patients received no study drug due to immediate postoperative death (n=1), consent withdrawal (n=2), use of another thromboprophylactic agent (n=2), surgery change or cancellation (n=2), and CrCl >50 mL/min just before surgery (n=2)
752076|NCT00555425||289 Patients underwent assessment for eligibility, 29 did not meet inclusion criteria, 132 lost contact or chose other treatment, and 15 did not complete induction
752077|NCT00555360||
752078|NCT00555321||
752079|NCT00555217||
752080|NCT00555152|Activated 1/17/2008 at Baylor College of Medicine (BCM), MD Anderson Cancer Center, Dana-Farber Cancer Institute, Mayo Clinic, Georgetown University & Walter Reed Army Medical Center; closed at BCM 3/8/2010, re-activated 9/19/2011 at MD Anderson, Dana-Farber Cancer Institute, Mayo Clinic & University of Alabama, Birmingham, closed 8/28/2014.|A total of 22 participants were enrolled and randomized to 3 of 4 treatment arms; Two of the 4 initial arms were removed in the second period with one of those having no enrollment. Three participants were enrolled while the study was open at BCM, the other 19 were enrolled after the study was transferred to MD Anderson (second study period).
752081|NCT00555061||
752082|NCT00555048||
752083|NCT00555009|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|
752084|NCT00554996||
752085|NCT00554970||This is a 4-treatment, 2-period crossover study. Subjects were randomized to receive either Treatments 1 (MAP0010 low dose) and 2 (Pulmicort Respules® 0.25mg) or 3 (MAP0010 high dose) and 4 (Pulmicort Respules® 0.5mg). Subjects were randomized to the following sequences: Tx 1 then Tx 2, Tx 2 then Tx 1, Tx 3 then Tx 4, or Tx 4 then Tx 3
752086|NCT00554853|Participant came into University of Michigan Rheumatology clinic learned about the study and then came in for baseline to sign consent or signed consent at screening visit and then came in for baseline visit at a latter date.|Out of the 144 individuals screened, one was not randomized to either arm.
752087|NCT00554840|Stable outpatients who received their regular treatment at the Outpatient Research Program of the MPRC were invited to participate.|"After the enrollment of 16 participants, a total of 7 participants were withdrawn from the study prior to assignment to a treatment group (n=9). Two subjects met exclusion criteria before any study procedures were started, and 5 subjects were withdrawn during either the evaluation or pre-med phases of the study."
752088|NCT00554801|Active duty military who were exposed to a blast while deployed and were patients at Walter Reed Army Medical Center; only mild or no traumatic brain injury|
752089|NCT00554788||
752090|NCT00554749|November, 2007 to July, 2008.Location: medical clinic|
752091|NCT00554671||
752092|NCT00554619||Study AMB107818 was an extension study of Study AMB107816 (NCT00540436).
752093|NCT00554515|Participants enrolled from 13 institutions between November 2006 and November 2008.|
752094|NCT00554463||
752095|NCT00554372||Subjects were randomized 1:1 to a treatment arm (dosage group). Randomization into the dosing groups was stratified by whether the Hepatocellular carcinoma was virally associated (hepatitis B virus or hepatitis C virus) or not virally associated.
752207|NCT00549172||
752097|NCT00554229|896 patients with hormone-resistant prostate cancer patients and bone metastasis were recruited between 20th November 2007 and 13th February 2009.|302 of the 896 enrolled patients were not randomised to treatments groups as they failed screening.
752098|NCT00554216|Subject recruitment occurred at investigative sites in the US between November 2007 through May 2008|
752099|NCT00554190|First subject treatment: May 2007. Last subject treatment: December 2007.|A total of 29 subjects were treated. Nineteen subjects were followed through 60 days post-treatment.
752100|NCT00554099|First patient screened 6 Dec 2007|Randomization 1:1:1 ratio with subsequent stratification based on number of prior episodes (1 attack vs. more than 1 attack).
752101|NCT00553969||
752102|NCT00553839||
752103|NCT00553787|Subject recruitment occurred at investigative sites in the US between November 2007 through May 2008|
752104|NCT00553735||
752105|NCT00553696||Three to 6 participants at each dose regimen were to be initially assessed for dose limiting toxicity (dose escalation cohort) and 10 participants were added to the maximum tolerated dose (MTD) group after MTD was determined at Sunitinib 25 mg once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2) regimen (MTD expansion cohort).
752106|NCT00553644|Between November 2007 and July 2011, 54 participants were recruited to this study.|One participant was deemed ineligible and removed for all analyses; therefore, 53 participants were analyzed.
752107|NCT00553631|The study was conducted in multiple sites from 29 January 2008 (first participant first enrolled) to 05 May 2009 (last participant completed).|Participants at least 2 years of age with type 1 Gaucher disease.Gaucher-disease-related anemia and at least 1 of the following: moderate splenomegaly, Gaucher-disease-related thrombocytopenia, readily palpable enlarged liver. Participants had not received treatment for Gaucher disease within 12 months prior to study entry.
752108|NCT00553605||
752109|NCT00553540||
752110|NCT00553514||
752111|NCT00553501|Between March 2008 and July 2009, 60 participants were recruited.|One participant was deemed ineligible and excluded from all analyses per study design.
752112|NCT00553475||After a 1-week baseline phase, subjects were classified into 2 strata based on creatinine clearance (CLcr) values (Low: 30 <CLcr <=60 mL/minute; Normal: CLcr > 60 mL/minute) and were each randomly assigned to 1 of 3 treatment groups.
752113|NCT00553462|Between March 2008 and October 2011, 78 participants were recruited to this study.|Three participants did not receive any protocol treatment and were excluded from all analyses.
752114|NCT00553436|Single Center, hospital based surgical suite. Enrollment from 20 August 2007 to 09 April 2009.|Non-randomized. Patients were considered for enrollment based on inclusion / exclusion criteria and were offered the opportunity for enrollment. Those that signed informed consent were enrolled.
752115|NCT00553410||
752116|NCT00553358||
752117|NCT00553332|Patients were enrolled to the trial between December 2007 and January 2009|
752118|NCT00553319||Study consisted of a one week single blind placebo run-in prior to group assignment. 139 participants were enrolled and 126 were randomized following the placebo run-up
752119|NCT00553280|Thirty-six (36) centers in Japan|Patients with pain associated with diabetic peripheral neuropathy who had completed the 13-week treatment phase in the preceding study (Study A0081163: NCT00553475), without any treatment-related serious adverse events or any compliance problems were eligible for the study.
752120|NCT00553267||
752121|NCT00553254||
752122|NCT00553202||
752123|NCT00553163|We aimed to recruit 66 patients from across London, but after >3 years could recruit only 26. Reasons for failure to complete recruitment included the relative rarity of this patient-group (ie with inactive ulcerative colitis (UC) for some years while on thiopurine, willing to stop the drug, and with time to complete the intensive programme).|
752124|NCT00553150||
752125|NCT00553098||
752126|NCT00553059|Recruitment Period: May 13, 2008 to October 26, 2011. Recruitment done in various medical clinics.|
752127|NCT00552929|The trial was conducted in seven centers in Europe: one center in Belgium, one center in Denmark, three centers in France, and two centers in The Netherlands.|
752128|NCT00552812|Recruitment opened February, 2008 and ended December, 2010|Patients were consented as outpatients, but final selection criteria were assessed in the catheterization laboratory
752129|NCT00552786|Participants recruited between November 2007 and January 2008.|A total of 60 workers voluntarily participated in this study. However, 6 workers had preexisting hearing loss of >50 dBA at high frequency and 1 worker accidentally turned off the noise monitoring device. These 7 participants were excluded from the analysis. The 53 workers who satisfactorily completed the study.
752130|NCT00552760|Recruitment began in October 2007 and was completed by August 2009. Participants, who at the time were receiving outpatient psychiatric services through Lehigh Valley Hospital, were recruited via referral through the department of psychiatry, and also through print advertisement. Participants received a $20 travel stipend for each appointment.|90 participants signed the informed consent document, 7 were screen failures, and 83 were randomized to receive either Ramelteon or placebo. During the study, both groups were maintained on their usual medications for bipolar disorder and were not allowed to have any meds changed, as this would signify a manic or depressed event.
752131|NCT00552695||
752132|NCT00552669|Between January 2006 to September 2007 we enrolled 200 patients in the trial.|From 1274 patients with coronary angiography, 789 met clinical inclusion criteria, from whom 102 have angiographic exclusion criteria. 487 were excluded for inability for percutaneous coronary intervention (PCI) with drug eluting stent (DES) deployment or refuse to participate in the study; thus 200 patients were included in this randomized trial.
752133|NCT00552617|Caucasian participants who had a surgical procedure using a general anesthesia of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block were enrolled in this study.|
752134|NCT00552578|12 participants recruited Dec 2007 to Apr 2008|
752135|NCT00552513||
752136|NCT00552448||
752137|NCT00552422||
752208|NCT00549055||
752209|NCT00549042||
752210|NCT00548886|Subjects recruited from Children's Healthcare of Atlanta (CHOA) February 2008 through January 2012|
752211|NCT00548860|Hospitals and medical clinics|
752138|NCT00552409|Ninety-three participants from medical clinics associated from the University of Washington (Seattle, WA) provided informed consent for this study between February, 2008 through June, 2009.|Of the 93 participants who provided informed consent, 63 were ineligible, 8 withdrew prior to randomization, and 22 were randomized to treatment.
752139|NCT00552396|32 subjects were enrolled and 21 subjects were screen failures|
752140|NCT00552344|The study started to enroll patients in May 2008 and concluded in Dec 2014. Participant Flow refers to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.|406 subjects were screened: 3 subjects were considered as screen failures and were not enrolled. 403 subjects entered the study from C87085. 1 subject was enrolled in this study, but did not receive any open-label study medication and was withdrawn from the study; this subject was, therefore, not included in any of the analyses.
752141|NCT00552305|The study was started in August of 2001 with recruitment occurring in the United States, Germany, Hungary, Lithuania, Poland, Sweden, Switzerland, and the United Kingdom. The study had last patient last visit in February of 2010.|
752142|NCT00552279||A total of 805 subjects were enrolled and 804 subjects were vaccinated and included in the analyses.
752143|NCT00552240|Patients were recruited from 28 Sep 2007 through 23 Mar 2009 at 18 sites throughout the US. The sites were comprised of medical centers or private practice physicians.|There was a 28 day screening period where a genotype report was run. If patients were resistant to any of the study medication, they were not to be randomized into the study. Patients also needed to meet all inclusion/exclusion criteria in order to be eligible. 154 patients were enrolled but 2 were not treated, leaving 152 in full analysis set.
752144|NCT00552188|Patients were screened between November 2007 and April 2009|Subjects had Acute Coronory Syndrome (ACS) 1-3 months prior to randomization and must have received concomitant statin therapy for a minimum of 4 weeks and had a stable statin dose regimen for 2 weeks prior to randomization.
752145|NCT00552175||Full Analysis Set Population consisted of all randomized patients who had at least one post-baseline measure of the primary efficacy variable.
752146|NCT00552110||
752147|NCT00552084|Participants were recruited at 4 medical centers in Nashville Tennessee, and at the Marsh field Clinic in Madison, Wisconsin. Between December 2007 and December 2012, 241 patients were enrolled and 190 (178 at Vanderbilt, 12 at other sites) were randomized to fish oil (126) or placebo (64). Of 190 enrolled, 173 (91%) completed the study.|Patients were >= 21 years old with a history of at least 2 occurrences of atrial fibrillation or atrial flutter, and in sinus rhythm at randomization. Randomization was performed according to a computer-generated block scheme according to anti-arrhythmic therapy: 1. no therapy, 2. amiodarone, 3. class 1 anti-arrhythmic drugs, 4.sotalol/dofetilide.
752148|NCT00552071|This study recruited subjects with active acromegaly. Equal numbers of men and women were to be recruited, but the recruitment plan was adjusted during the course of the trial to account for the high number of women withdrawn from the study. 12 women and 9 men were recruited; 8 men and 7 women completed the study and were included in the analysis.|Subjects who had not received 3 monthly injections of a stable dose of octreotide LAR prior to enrollment were given 3 monthly injections of octreotide LAR at a stable dose of 30 mg every 28 days or at a dose determined by historical dosing. Nine of the 15 subjects participated in this run-in period.
752149|NCT00552058||Participants flow shows all subjects randomized. Safety analyses are based on actual treatment received; 1 subject randomized to placebo did not receive any treatment thus would be excluded due to the definition of the safety population.
752150|NCT00552032||135 participants were screened, a total of 132 participants were randomized to receive either Mometasone furoate nasal spray (MFNS) (n=66) or placebo nasal spray (n=66).
752151|NCT00551759|Participants were recruited from ECOG member institutions between June 10, 2008 and January 8, 2010.|
752152|NCT00551746|Recruitment period: August, 2007 to June, 2009|
752153|NCT00551707||
752154|NCT00551642|Thirty-five Medical Centers participated and enrolled a total of 800 subjects (Intent to treat population). The study allowed for a 2 year recruitment and intervention period followed by 7 years of clinical follow up.|
752155|NCT00551525||
752156|NCT00551460||
752157|NCT00551421|3 patients were enrolled into the original protocol between 11/07 and 05/08. 1 subject developed Grade 3 diarrhea, all 3 subjects experienced significant skin toxicity. The protocol was therefore amended to recruit cetuximab-refractory mCRC patients only. 14 patients were enrolled in this part of the study between 03/09 and 07/10 at 6 US centers.|One patient enrolled into the amended part of the protocol withdrew consent prior to receiving any study drug.
752158|NCT00551369||
752159|NCT00551291||
752160|NCT00551213||
752161|NCT00551200||
752162|NCT00551174|Study enrollment was to occur at centers that had participated in BM16550 (NCT00048074) in North America, Mexico, Europe, Australia, and South Africa.|Postmenopausal osteoporosis. Patients having completed study BM16550 (NCT00048074) and who had complied with the intravenous (IV) regimen during the second year of study BM16550 (NCT00048074) for 75% or more.
752163|NCT00551161|August, 2007 through May, 2010, at the Litwin-Zucker Research Center|
752164|NCT00551135|Male subjects were enrolled at 34 centers and participated in the study between 18 January 2008 and 14 September 2009.|
752165|NCT00551070|The study was activated on 9/22/2008 and closed to accrual on 1/31/2011 (suspended from 1/4/2010 to 8/9/2010).|
752166|NCT00551031|Participants were enrolled from 24 October to 31 October 2007 in 31 medical centers in the US.|A total of 2095 of the 2098 enrolled participants who met the inclusion and exclusion criteria were vaccinated.
752167|NCT00550953||
752168|NCT00550862|Recruitment for the 747-202 study began in November 2008. This was an international, multi-center, randomized, double-blind, placebo-controlled, multi-dose study with the majority of the sites being academic centers.|Patients were required to meet the Inclusion and Exclusion requirements as per protocol. Patients were screened and those who met the required criteria were randomized to the trial.
752169|NCT00550836||
752170|NCT00550771||
752171|NCT00550745|"Phase IV
~First subject enrolled on 17-Sep-2007.
~Last subject enrolled on 19-Jun-2008.
~The last subject's last visit was 15-Jan-2009.
~The study was conducted at 46 study centers throughout the United States, Canada, Germany,
~Spain, and United Kingdom."|
752178|NCT00550537|The recruitment period for this trial was October 2007 to July 2011. Participants were recruited at Vanderbilt Medical Center, Emory University, M.D. Anderson Cancer Center, University of Florida - Gainesville.|10 participants were consented to participate in this trial, but were determined to be ineligible; 3 participants withdrew from the study prior to beginning treatment; 1 participant progressed before beginning treatment.
752179|NCT00550459|16 United States (US) sites/clinics; first subject signed informed consent on 9/11/07; last subject's final visit on 12/16/08|
752180|NCT00550446||
752181|NCT00550420|A total of 331 participants who had completed the double-blind treatment phase in AVA105640 were enrolled. Only 26 participants completed the study as it was early terminated, 206 participants were still enrolled at the time of study termination while 97 participants withdrew prematurely. The study completion status of 2 participants was missing.|The enrolled participants had successfully completed Visit 8 of AVA105640 without safety/tolerability issues. For safety endpoints, 'baseline' referred to the current study baseline assessment, (AVA102677 Visit 1). For efficacy endpoints, the term 'baseline' referred to the baseline assessment of the parent study (AVA105640), Visit 3.
752182|NCT00550407||Participants whose symptoms of mood episodes were stabilized with lamotrigine in the Preliminary Phase (Clinical Global Impressions of Severity score of 3 [mild] or less for at least 4 consecutive weeks, and lamotrigine given as monotherapy for at least 1 week before the start of the Randomized Phase) were randomized to placebo or lamotrigine.
752183|NCT00550394|56 study participants were consented for study participation, of which 17 were screen fails.|56 study participants were consented for study participation, of which 17 were screen fails.
752184|NCT00550368|Patients were recruited for the study from 2005 to 2008. Enrollment began 6/2005 and ended 5/2008. Healthy individuals were sought with no chronic medical conditions or symptoms.|Participants were assigned to one of two groups: Helicobacter pylori positive, or Helicobacter pylori negative. Assignment was based on results of H. pylori serology and Urea Breath Test. Test results had to be concordant for group assignment.
752185|NCT00550290|From July, 2007 through December, 2008, all patients undergoing surgical treatment for vulvar cancer at a single tertiary care center were offered enrollment and randomization.|
752186|NCT00550277||
752187|NCT00550238|"Eligible patients were adult males or females with Parkinson's Disease Psychosis who had completed a prior double blind study with pimavanserin and were determined by the treating physician (Investigator) to benefit from continued treatment. This study did not have a fixed duration. Thus, no patients were considered to have completed the study."|Patients could be enrolled in this study as early as the final visit of the previous double-blind study, or up to 28 days following completion of the treatment period of the previous double-blind study.
752188|NCT00550173||
752189|NCT00550147|Subjects were recruited during the time period 2004-2005, using flyers and letters sent to local schools, clinics, and community agencies, as well as from referrals to the site at which the study was conducted.|All eligible subjects were assigned to the first phase of treatment (Oros MPH alone).
752190|NCT00550043||
752191|NCT00549939|The study was conducted at 55 sites in 18 countries. A total of 261 patients were screened between September 2007 and November 2008.|"172/261 patients were randomized in the 12-week double blind phase.
~89/261 patients were not randomized for the following reasons:
~Adverse event (1 patient*),
~Inclusion/Exclusion criteria not met (69 patients*),
~Subject's request (11 patients*),
~Other (13 patients*).
~'*' Patients could have several reasons."
752192|NCT00549900||
752193|NCT00549822|Postmenopausal patients with ER-positive (ER+) metastatic breast cancer (MBC) that were enrolled on an institutional review board (IRB) approved, phase II, multicenter clinical trial protocol (NCT00549822) evaluating intermittent AI (Aromatase Inhibitor) therapy. The study opened to accrual August 29, 2006 and closed to accrual on May 17, 2010.|
752194|NCT00549783||
752195|NCT00549770|The study comprised 3 periods: a 4-week washout and placebo run-in period (pre-randomization), an 8-week randomized, double-blind monotherapy period, and 1-week randomized, placebo-controlled withdrawal period. In the randomized withdrawal, participants were either randomized to placebo or continued their original assigned treatment.|After successful completion of the pre-randomization period, participants were randomized 1:1:1:1:1:1:1:1 ratio to one of 8 treatment groups.
752196|NCT00549757||Per data monitoring committee (DMC) recommendation all patients were required to permanently stop study medication by 06Jan2012. A follow-up period (actual duration, 9 months in average) post study drug discontinuation on 7590 patients was implemented upon request of Health Authority following the recommendation of DMC to cease study treatment.
752197|NCT00549718||
752198|NCT00549640|Recruitment for this study began on 03/10/08 and the final subject was randomized to study drug on 11/4/08. All subjects were recruited at Mayo Clinic in Rochester, MN.|After obtaining consent, subjects were screened for study inclusion. If they passed study entry criteria, they were randomized to study. All randomized subjects were included in the analysis.
752199|NCT00549601||
752200|NCT00549562||
752201|NCT00549549||A total of 443 participants were screened, of which 402 participants were assigned to treatment and 400 received treatment. One participant (indomethacin 50 mg) was not treated as they were no longer willing to participate in the study, and one participant (celecoxib 800/400 mg) was not treated due to due to insufficient drug quantity at site.
752202|NCT00549445|Protocol Open to Accrual: August 2007, Primary Completion Date: July 2011 and Study Completion Date: July 2012. Recruitment location: University of Alabama at Birmingham and the Mayo Clinic.|This research was conducted as an ancillary study to a multicenter trial (NCT00325897) of the efficacy of azithromycin treatment for 1 year in preventing chronic obstructive pulmonary disease (COPD) exacerbations to test whether sputum levels of proline-glycine-proline (PGP) were altered by treatment or associated with exacerbation frequency.
752203|NCT00549393|The hospital ICU units underwent a crossover study design, so the ICUs recruited participants in the assigned treatment or control group, then the unit had a washout period, then the unit switched to the alternative assignment of intervention or control for a separate population of participants that were admitted into the ICU.|5659 enrolled visits in the study, but 712 were excluded from analysis as they did not meet the eligibility criteria
752204|NCT00549328||
752205|NCT00549302||Participants were previously enrolled in H6D-MC-LVGY (NCT00125918), a placebo-controlled double-blind study.
752206|NCT00549198||
752212|NCT00548847|All patients were enrolled at the Winship Cancer Institute of Emory University. The study closed to accrual in May 2011.|
752213|NCT00548808||3 patients randomized but did not receive study drug: 1 withdrew, 1 did not want to use insulin, 1 lost to follow-up. Full Analysis Set: randomized, received at least 1 dose of study drug. Per-Protocol Set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.
752214|NCT00548717|Participants were recruited at Dana Farber Cancer Institute. The first participant was enrolled in November 2007. Enrollment was halted May 2008 due to an unacceptable rate of acute GVHD. The study reopened in November 2012 with addition of bortezomib. The last participant enrolled May 2013. The study was permanently closed to accural August 2013.|
752215|NCT00548691|Hospitals and medical clinics|
752216|NCT00548652||
752217|NCT00548548||
752218|NCT00548470||
752219|NCT00548431|38 patients were recruited in 3 different countries. Recruitment period 12/01/2007 - 12/21/2008. All recruitments were done in departments of Pediatric Hematology/oncology|
752220|NCT00548418|Enrollment to the study opened to participants on 02/20/07 and enrollment to the study was closed to participants on 11/07/11.|
752221|NCT00548405|Participants were screened at 192 investigational sites between October 10, 2007 and September 15, 2011.|
752222|NCT00548340||
752223|NCT00548327|Normal volunteers or patients with schizophrenia will be initially recruited from among individuals who have volunteered for previous genetic studies and for whom genetic data is already available. Power calculations set target accrual at 30 participants per genotype for 3 COMT genotypes per cohort (i.e., 90 patients and 90 healthy volunteers).|Subjects need to satisfy the inclusion/exclusion criteria for the genetic studies protocol before participating. Normal volunteers will be enrolled as outpatients and patients as inpatients. Females do both arms during the same phase of the menstrual cycle. Patients with Schizophrenia are stabilized for at least 6 weeks before the protocol.
752224|NCT00548262||The planned sample size for this study was 210 subjects; however, due to slow enrollment, only 54 subjects were screened and randomized.
752225|NCT00548249|131 patients randomized and dosed between 27 Aug 2007 and 28 Apr 2009, across 29 study sites in U.S. and Canada.|No run-in or transition.
752226|NCT00548197||
752227|NCT00548184||
752228|NCT00548171||
752229|NCT00548145||Hyperlipidemia patients with mild to moderate Alzheimer's disease(MMSE15～23)
752230|NCT00548132|The patients were recruited from two ICUs at BJH. The nurse was asked to page the research coordinators on patients who were scheduled to have a central venous catheter placed for IV access.|Patients or family member authorized to consent for the patient (if the patient was not competent to consent to the study) were approached by study personnel for inclusion into the study. Written informed consent was obtained for all subjects and randomization group was assigned in blocks of 4.
752231|NCT00548093||
752232|NCT00548041||
752233|NCT00547911||
752234|NCT00547898||
752235|NCT00547703||
752236|NCT00547638|Study subjects were recruited from the general population ≥1 year of age who were treated in an Emergency Department/Urgent Care Setting.|
752237|NCT00547586||
752238|NCT00547534|Recruitment at the University of Rochester Medical Center, Weill Cornell Medical Center and the University of Nebraska began in October 2007 and ended in March 2009. Patients were recruited in a medial clinic setting.|
752239|NCT00547521|Short term (ST) Study results (2 arms) were released in 2010. Final long term extension (LTE) results (1 arm with pooled data), up to 2014, are now included. During the LTE Study, 125 mg abatacept, was continued to be self-administered weekly and adjustments to RA medications including MTX were permitted at investigators discretion.|119 participants enrolled;100 treated in the ST Study. Reasons not treated: 17 no longer met criteria, 2 withdrew consent. 96 completed ST treatment but only 95 completed Primary endpoint evaluation. 90 enrolled in LTE Study. Reasons why participants did not enroll in LTE Study: 2 lack of efficacy, 2 had adverse events, 1 no longer met criteria.
752240|NCT00547456|recruitment details occurred as outlined in protocol|
752241|NCT00547378|Thirty-eight centers were activated to enroll subjects. In total, 571 subjects were enrolled: 243 randomized cohort (96 excluded due to eligibility failure); 328 non-randomized cohort (102 excluded due to declined to participate; did not meet inclusion criteria and other). Subjects were enrolled between November 2007 and March 10, 2011.|The study has 2 cohorts. The randomized cohort included subjects who were randomized 1:1 to either InterStim Therapy (IST) or Standard Medical Therapy (SMT) and were followed for 6 months. The all implanted cohort include implanted subjects from the randomized cohort plus additional subjects enrolled after randomized cohort enrollment completion.
752242|NCT00547365|Overall study length - 2007-2011; Location - medical clinic|Patients with primary light-chain (AL)-associated amyloidosis that caused heart dysfunction were on study.
752243|NCT00547300|Patient recruitment occurred over a four month period from October 2007 to January 2008 at 39 US sites.|All patients went through a 4 week hydrochlorothiazide (HCTZ) run-in phase before randomization.
752244|NCT00547248||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
752245|NCT00547157|152 subjects were enrolled with 90 subjects randomized to panitumumab plus radiotherapy arm, and 62 subjects randomized to chemoradiotherapy arm.|
752246|NCT00547118||18 participants signed consent for the study. 1 participant was withdrawn prior to randomization, 2 participants (one from each group) withdrawn after randomization but prior to drug initiation. n=15 participants included in data analysis for aims 1, 2, 8, 9, 10, and n=14 analyzed for aims 3-7 due withdrawal prior to EOS neruopsych testing.
752247|NCT00547105||
752248|NCT00546910||
752249|NCT00546897|The study opened to participant enrollment on 02/02/2007 and closed to participant enrollment on 03/04/2009.|
752250|NCT00546884||
752251|NCT00546871|Recruitment was conducted in the United States at 9 study sites.|53 participants who enrolled were screened. Of these, 4 withdrew before treatment (1 death, 1 screen failure, 2 requested withdrawal)
752252|NCT00546819||
752255|NCT00546715|The study was conducted at 7 centers in United States.|A total of 95 participants were enrolled, of which 18 received treatment. Remaining 77 participants were not randomized (participants either no longer met study criteria by the time of randomization or were no longer needed as an adequate number of study participants had already been dosed in each dose panel).
752256|NCT00546637||
752257|NCT00546572||
752258|NCT00546481|A total of 80 participants were enrolled in this study conducted from 05 November 2007 to 23 December 2009 at 7 centers in Korea.|
752259|NCT00546429|Between September 2006 & September 2009, 62 subjects were recruited and enrolled at 6 US clinics by orthopaedic surgeons. Each study site could enroll up to 20 subjects (cohorts were re-assigned as necessary to complete enrollment in a timely manner). Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.|This was a non-randomized study so all subjects that met the inclusion/exclusion criteria received the ATN Trochanteric Nail. Consented subjects could be excluded from the trial based on results of pre-operative clinical and/or radiographic evaluations, as per the exclusion criteria in the clinical investigation plan.
752260|NCT00546390||2 patients were withdrawn for logistical reasons
752261|NCT00546377||
752262|NCT00546364||Of 62 participants enrolled, 62 were randomized and received treatment. Investigators had to terminate the study because an adequate number of participants could not be enrolled.
752263|NCT00546351|The study started in May 2004 with subjects from Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, and United Kingdom. The primary completion date occurred in January 2011, with study completion in January 2011.|Participant Flow and Baseline Characteristics refer to the Safety Set (SS).
752264|NCT00546273|Four RUTI doses were tested, in a sequencial way (n=6 each). 14 days before starting each level of treatment, subjects, after signing the informed consent, were screened in the Phase 1 Unit (Hospital Germans Trias i Pujol) in order to decide if they were elegible to be part of the study.|24 volunteers were enrolled and distributed in 4 groups, one group for every period (each period: 6 new volunteers). There was one period per dose tested, and doses were tested increasingly, not beginning to test one dose until clinically ensured the safety of the previous dose. The double blind was opened at the end of the study.
752265|NCT00546260||
752266|NCT00546156|Study was activated on 10/17/2007 and Closed to accrual on 7/1/2011.|
752267|NCT00546117||
752268|NCT00546104|Subjects will be identified in cancer center outpatient clinics multi-site. The study will be introduced by a physician or caregiver known to the patient. We will need to review protected health information in order to identify subjects, and information resulting from this activity will be used only to assess eligibility of a subject.|Meds which inhibit platelet function/coagulation,potent inhibitors of cytochrome CYP3A, or meds that prolong the QT interval during study require a 7 day wash-out.IV bisphosphonates must be held for 2 wks before/6 wks after trial tx. Subjects must be 3 wks since prior to therapy, 2 wks since surgical bx and 3 wks since major surgery.
752269|NCT00546078||One subject that enrolled into the study was not vaccinated and as such not reported as started in the participant flow.
752270|NCT00546052|First Patient In: 12-Sep-2005 Last Patient In: 29-Dec-2006 Last Patient Last Visit: 31-Jan-08 Total number of Sites (General Practitioners and Family Physicians in Canada): 209|24 patients not included in the Intention to Treat (ITT) analysis because they did not receive study medication and had no follow up visits. Total ITT population = 1714.
752271|NCT00546000||
752272|NCT00545974|We recruited patients from nine US academic dementia research centres with expertise in the diagnosis of FTD. Study visits occurred between December 12, 2007, and May 7, 2012.|100 subjects were assessed for eligibility. 19 were excluded prior to randomization. 81 were randomized. 16 subjects did not meet inclusion criteria and 3 declined to participate.
752273|NCT00545948||A total of 31 patients were registered, but 7 patients were not assigned treatment due to genomic screening failure or study ineligibility. The remaining 24 patients were assigned to the vinorelbine and pemetrexed treatment arms.
752274|NCT00545844|"First 25 asthmatic patients seen consecutively at each site were invited to participate.
~Treatment phase: From the Survey population, blocks of 8 were allowed to participate. All subjects took 1 tablet of montelukast 10 mg once a day at bedtime.
~First patient in: APR-02-2007 Last patient out: JAN-25-2008"|The anticipated Enrollment was 440, with an expected rate of 20% over the 8-week period, thus 369 patients should complete the study.
752275|NCT00545818|"97 subjects were enrolled in the study (singed informed consent).Two of those subjects fulfilled exclusion criteria and were removed from the study population before randomization.
~As a consequence a total of 95 subjects were randomised (assigned to groups) and received study treatment."|
752276|NCT00545792|Recruitment period was between 2008-2010. Patients seen in consultation in a gynecologic oncology or radiation oncology clinic at any of the participating institutions and recommended to undergo radiation for recurrent gynecological cancer were evaluated for eligibility.|Pretreatment evaluations included medical interview, blood pressure check, complete blood count, chemistries, urine analysis and liver function tests. Tumor biopsy was performed at diagnosis. Radiologic imaging (CT, PET-CT, or MR) was performed at diagnosis.
752277|NCT00545779||
752278|NCT00545766||
752279|NCT00545753|The first subject signed an informed consent and enrolled into the study on 25 September 2007; the last follow-up visit occurred on 22 April 2008.|After admission to the study, subjects could have withdrawn at any time for any reason such as they no longer met the eligibility criteria, personal reasons, etc.
752280|NCT00545740||
752281|NCT00545714||A total of 86 participants were enrolled in 29 centers in Spain in this two-phase study (Induction Phase and Maintenance Phase).
752282|NCT00545688|A total of 107, 107, 107, and 96 participants (total 417) were randomized to Arms Trastuzumab plus (+) Docetaxel (T+ D) , Trastuzumab+Pertuzumab+Docetaxel (T+Ptz+D), Trastuzumab+Pertuzumab (T+Ptz), and Pertuzumab+Docetaxel (Ptz+D), respectively and were included in intent-to-treat population (as randomized).|"3 participants did not receive correct treatment, as randomized, and 1 (in Arm Trastuzumab + Docetaxel) did not receive any treatment. Safety population (as treated) included 107, 107, 108, and 94 participants in Arms 'T+D', 'T+Ptz+D', 'T+Ptz', and 'Ptz+D', respectively. Participant flow was available for As Treated participants."
754278|NCT00437034|A total of 6 patients were enrolled at two institutions between January 2007 and April 2010|
752283|NCT00545662|Participant were recruited from eight level I trauma centers: Virginia Commonwealth University; University of Maryland; Temple University; University of Tennessee; University of Alabama (Birmingham); University of Texas Southwestern (Dallas); University of Pittsburgh; University of Washington. Recruitment began on 7/23/2007 and ended on 2/4/2011.|
752284|NCT00545623||
752285|NCT00545584||1512 subjects were selected/screened, 380 subjects failed screening, leaving 1132 subjects who were randomized.
752286|NCT00545571||
752287|NCT00545532||Participant flow is provided for the safety analysis population, which was the primary analysis population for evaluation of safety. Safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization. Participants were reported under the actual treatment received.
752288|NCT00545506|research personnel will screen the patient list one day before surgery to identify eligible patients|
752289|NCT00545441||
752290|NCT00545402||
752291|NCT00545363||
752292|NCT00545298|single site, 4 subjects recruited starting in October, 2007 with the last vist on August 28, 2008|
752293|NCT00545272||
752294|NCT00545233||Patients randomized to the pioglitazone arm participated in a 16-week pioglitazone run-in (Week -16 to Week 0) prior to beginning anti-HCV therapy: PEG-INF alpha-2a [Pegasys] plus ribavarin [Copegus]. Patients randomized to the without pioglitazone arm started anti-HCV therapy immediately.
752295|NCT00545181||
752296|NCT00545168|The first subject signed an informed consent and enrolled into the study on 21 September 2007; the last follow up visit occurred on 8 April 2008.|After admission to the study, subjects could have withdrawn at any time for any reason such as they no longer met the eligibility criteria, personal reasons, etc.
752297|NCT00545155||
752298|NCT00545103||
752299|NCT00545077||
752300|NCT00545064|"First patient in: MAY-23-2007
~Last patient out: OCT-15-2008
~Total number of sites: 28 sites in Canada. (Study performed in Canada only)."|
752301|NCT00545051||
752302|NCT00545025|Subjects enrolled and vaccinated in this NCT00545025 follow-up previously participated in the NCT00374842 study, wherein they were vaccinated with either the GSK1247446A or Fluarix™ vaccines.|Subjects were allocated to study groups based on their vaccination course in the NCT00374842 primary study, so as to receive a re-vaccination dose of the vaccine previously administered.
752303|NCT00544908||
752304|NCT00544882|Female volunteers, aged 18-35 years old who were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) were enrolled at 4 investigative sites in the United States.|67 women were screened for participation in this study; 61 were enrolled and took at least 1 dose of their current regimen of oral contraceptive in Cycle 1 (the Run-in Cycle). Of the 61 enrolled, 3 participants discontinued the study prior to completing the Run-in Cycle and were therefore not randomly assigned to study drug in Cycle 2.
752305|NCT00544869||
752306|NCT00544817|Between April 2007 and July 2008, 47 patients were enrolled|
752307|NCT00544778||
752308|NCT00544713||
752309|NCT00544674||
752310|NCT00544648|Patients were recruited from November 2007 through September 2011|Twenty-two patients signed consent on this study, nine of which were ineligible to receive treatment.
752311|NCT00544557||A total of 1715 participants were enrolled for documentation. Of these 1715 participants enrolled, only 1685 participants were included in analysis.
752312|NCT00544544||
752313|NCT00544440||
752314|NCT00544167||
752315|NCT00544076|"10 patients were not randomized, for the following reasons:
~ineligible upon surgery - 4 patients
~patient withdrew or not returning to COH - 2 patients
~did not have BNS procedure -- 2 patients
~(5) deemed to have sensitivity to MUSE -- 2 patients"|
752316|NCT00543985|Patients were recruited as part of the parent study on Weight Regain (PI Tom Thomas) funded by NIH. These patients were recruited from clinics, volunteers from advertisements. Patients needed to have 2 of 5 criteria for the Metabolic Syndrome (MetS) plus have obesity.|All patients in this study had successfully been screened as part of the parent study. All patients were to exercise (aerobic) and have a 10% weight loss. Echocardiography was performed prior to and immediately following a maximal stress test at the end of 12 weeks of exercise.
752317|NCT00543855||167 participants initiated the Observation period, 140 participants were enrolled in the treatment period, one participant did not receive treatment.
752318|NCT00543803||
752319|NCT00543764|2006-2008. Operating room records|
752320|NCT00543725|A phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects|680 participants were randomized (340 in TMC 278 and 340 in efavirenz) but only 338 participants were treated with efavirenz (2 were randomized but not treated).
752321|NCT00543569|This study enrolled de novo kidney transplant recipients who were at least 18 years of age.|
752322|NCT00543543||A total of 15,334 participants were screened and 14,840 were randomized into the study.
752323|NCT00543439|Participants for 1 of the sites, were excluded from efficacy and safety analysis due to data integrity issues, however were reported in participant flow and baseline analysis.|
752324|NCT00543400|503 patients undergoing elective percutaneous coronary intervention at 43 centers in the United States and Canada were randomized|
752325|NCT00543387||35 participants were enrolled and treated in this study. 14 enrolled into Panel 1 and received MK-5108 monotherapy. An additional 4 enrolled into Panel 1 and received MK-5108 as monotherapy prior to crossing over to Panel 2 and receiving MK-5108 with docetaxel. 17 enrolled into Panel 2 and received only the combination of MK-5108 and docetaxel.
752326|NCT00543309|"Recruitment period: October 2007 - January 2013.
~Location: Cardiac operating rooms and cardiac intensive care unit (CICU) at Boston Children's Hospital"|
752327|NCT00543296|Of these 21 subjects, 14 subjects had recurrence of inflammation and were re-implanted|
752328|NCT00543140||
752358|NCT00541346|16 enrolled Study Start Date: September, 2007 Study Completion Date:May, 2009 Seen at OU Physician's Child Study Center.|
752359|NCT00541307||
752329|NCT00543127|870 patients were recruited, from them, 437 were randomized to Anastrozole (A) and 433 to A plus Fulvestrant (F), but 18 patients (3 in A arm and 15 in arm A+F) never received treatment.|
752330|NCT00543101|Five multicenter sites were used these included medical and research clinics.|
752331|NCT00543062||Eligible subjects reported to the CRU for baseline assessments (Day 1). The subjects were confined to the Clinical Research Unit under continuous medical or paramedical observation until at least 24 hours after each dose of Staccato Prochlorperazine or placebo.
752332|NCT00542997|This multinational study enrolled subjects at 15 of the participating study centers in Europe.|Screening took place 1 to 4 weeks prior to the first IgPro20 infusion.
752333|NCT00542971|Recruitment Period: October 2007 to February 2009. All participants were registered at The University of Texas M.D. Anderson Cancer Center.|Of the 78 participants registered on this study, three (3) were excluded prior to receiving treatment.
752334|NCT00542919||Completers include participants who had progressive disease, died due to any cause or alive and on study at the end of study, but off treatment.
752335|NCT00542880|706 subjects were enrolled; 264 were not randomised: 190 with eligibility not fulfilled, 11 with adverse events, 4 with discontinuation criteria, 40 voluntary discontinuations, 2 lost to follow-ups, 6 non-compliance, 1 for safety reasons, 10 with other reasons not specified. 442 subjects were randomised|
752336|NCT00542828|Enrollment period: 05 November 2007 through 06 May 2009. Study participants were enrolled at 7 study centers in Europe.|Because the study was terminated early due to slow enrollment, only 16 participants were enrolled in the study. Of these, 14 participants went on to receive treatment with Thymoglobulin.
752337|NCT00542815||
752338|NCT00542789|343 randomised participants 341 in Full Analysis set and safety analysis set. Full set used for summaries of baseline char. and efficacy variables. Safety set used for summaries of safety variables. 2 excluded, took no investigational drug or had protocol deviation. 173 Esomeprazole 20 and 168 placebo had baseline information and were summarised.|Out of 1246 enrolled participants, 343 participants were randomised and 903 participants were not randomised. The major reasons of no randomisation were 'Did not meet eligibility criteria' (877 participants) and 'Voluntary discontinuation by participant' (24 participants).
752339|NCT00542750|24 participants were recruited over 9 months in 2008-2009.|After informed consent, an assessment/screening visit was used to determine if prospective participants met criteria for inclusion. Briefly, participants were required to be regular cannabis users meeting current criteria for dependence. Participants with unstable psychiatric or medical issues were excluded.
752340|NCT00542620|Four centres in France|Children with type 1 diabetes currently treated with insulin detemir and insulin aspart and with a good glycaemic control. At trial entry, subjects must be 6-18 years old with a HbA1c (glycosylated haemoglobin) below or equal to 8.6%
752341|NCT00542542|Recruitment Period: September 10, 2007 to February 28, 2011. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 89 participants enrolled, one participant was excluded prior to group assignment.
752342|NCT00542490||
752343|NCT00542425|Recruitment for the study started in the US, in January 2007. For the initial 24-week treatment period, patients were randomized to study treatment at 30 study centers in the US, Argentina, India and the UK . Eleven of the 30 study centers treated patients in the 24-week treatment extension period in the US, Argentina, and India.|After eligibility was established, patients entered a 4-week Pretreatment Period during which they received daily Calcium and Vitamin D supplements, were trained in self-injection with the pen devices, and were assessed for additional evaluations at the end of the Pretreatment Period. Patients who remained eligible were randomized on Day 1.
752344|NCT00542386||
752345|NCT00542321|Recruitment period spanned 8.6 months (between 09/28/07 - 04/30/07 and 05/01/09 - 08/31/09) and was done in 2 ICUs of 2 tertiary hospitals. Recruitment efforts were intermittent due to staffing resources and reconfiguration and testing of automated turn bed angle sensor.|Not applicable. All enrolled patients assigned to group.
752346|NCT00542308||All patients attending Visit 2 were included in the FAS irrespective of their compliance with the planned course of zalutumumab.
752347|NCT00542269||
752348|NCT00542191||
752349|NCT00542178|Recruitment for the ACCORD Eye study was restricted to participants recruited as part of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. The ACCORD Eye study began in October 2003, with 3472 participants enrolled by February 2006.|All participants were enrolled in either the intensive or standard glycemia control arms. In addition to inclusion in the glycemia control part of the trial, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo).
752350|NCT00541970|The study included two phases, an active vaccination phase (Months 0-7) followed by a safety follow-up phase (up to the end of the study at Month 60).|The study was run in an open manner for subjects in the groups receiving the Cervarix vaccine on a 3-dose vaccination schedule. For subjects in the group receiving the Cervarix vaccine on a 2-dose vaccination schedule, the study was run in an observer-blind manner until Month 24, and then in an open manner.
752351|NCT00541931|Healthy female volunteers in the community aged >50 years|
752352|NCT00541866|Conducted in 7 centers in the USA between 2007 and 2010|"Dose-escalation phase Group 1 (Sch A, 10 to 90 mg/m2): 41 patients (39 treated) Group 2 (Sch B, 70 to 90 mg/m2): 18 patients
~Dose-expansion phase Group 3 (Sch A first relapse, 80 mg/m2): 17 patients Group 4 (Sch B first relapse, 90 mg/m2): 16 patients Group 5 (Sch B primary refractory, 90 mg/m2): 18 patients Total: 110. Treated: 108"
752353|NCT00541775|First Patient In: 16-June-2006. Last Patient Last Visit: 2-March-2007. 13 medical clinics in 3 countries in Europe and 23 in 4 countries in the rest of the world|Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) who were taking metformin monotherapy at a stable dose of ≥ 1500 mg/day for at least 10 weeks and had inadequate glycemic control (hemoglobin A1C ≥ 7.0% and ≤11%) were eligible to participate.
752354|NCT00541671||
752355|NCT00541658|923 women with PMO at 43 sites in 8 countries across North America, South America, and the European Union. Patients were randomized within a site to 1 of 3 treatment groups (35 mg delayed-release Risedronate, given once-weekly before/after breakfast, and 5 mg immediate-release Risedronate, administered once-daily before breakfast) in a 1:1:1 ratio.|
752356|NCT00541593||
752357|NCT00541450||
752360|NCT00541242||
752361|NCT00541229|First Patient In: 17-Oct-2007; Last Patient Last Visit: 01-Jul-2008; Seventeen medical clinics worldwide (8 in the United States, 8 in Europe and 1 in Mexico).|Following a 4-week (wk) diet/exercise (and wash-off period for patients on antihyperglycemic agent [AHA]), patients with fasting plasma glucose (FPG) 130-250 mg/dL were eligible to enter a 2-wk placebo run-in period prior to randomization.
752362|NCT00541190|Cystic fibrosis subjects were recruited during normal clinical visits. Healthy control subjects were recruited using posted advertisement.|All enrolled subjects performed a single nuclear medicine imaging study.
752363|NCT00541099||
752364|NCT00541034||
752365|NCT00540982||
752366|NCT00540969||
752367|NCT00540722|Patients were enrolled on this study from Jan 2008 through September 2008. Patients were enrolled in an outpatient setting at 9 oncology clinical sites|
752368|NCT00540644||
752369|NCT00540592||
752370|NCT00540579||
752371|NCT00540514||Eligible patients were randomized on Day 1 in a 1:1 ratio into 1 of 2 treatment arms and were required to start treatment within 7 days of randomization. The data below represent a cut-off of 31 January 2011. One patient was randomized twice and not included in the Intent-to-treat population.
752372|NCT00540449|One hundred and twelve sites in 21 countries randomized participants. In total, 694 participants were randomized: four participants did not start treatment and 690 participants started treatment (346 in the TMC278 group and 344 in the efavirenz [control ] group).|
752373|NCT00540436||
752374|NCT00540423||
752375|NCT00540293|Study was conducted at 20 centers in Korea|Participants who were on antilipidemic medications at the time of screening required a 6-week washout period prior to study treatment
752376|NCT00540228||
752377|NCT00540124||There were three periods to this study. Period 1 was a 4-week Screening/Washout Period. 196 subjects screened (45 failures). Period 2 was a 4-week Placebo Run-in Period. Period 3 was a 12-week Treatment Period (151 subjects randomized).
752378|NCT00540046||
752379|NCT00540007||
752380|NCT00539994||
752381|NCT00539942|Patients were recruited from the UAB Gynecologic Oncology Practice from 4/2007 to 6/2010|Difficulty with recruiting subjects to this trial (subjects were not interested in participating)
752382|NCT00539864|Subjects 50 - <64 years of age were screened in participating outpatient clinics for eligibility within 30 days of randomization during the 2007 influenza season.|Subjects whose laboratory values were exclusionary were not randomized. Women of child-bearing potential were required to have a negative pregnancy test.
752383|NCT00539838|A maximum screening window of 14 days was allowed.|During the screening period, participants received oral prednisone after the physician's evaluation and scoring of a BILAG questionnaire.
752384|NCT00539734||
752385|NCT00539695||
752386|NCT00539656||
752387|NCT00539617|Recruitment is performed in the Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco|This trial has a pre-enrollment phase in which patients have their tissue tested for Kras and EGFR mutations to determine eligibility for the treatment trial. There is also a run-in phase with Erlotinib followed by a post-treatment biopsy. After this, the main treatment phase begins.
752388|NCT00539591|A total of 29 patients were enrolled between May 9, 2008 and August 22, 2012. Of the 29 participants, 21 were enrolled at St. Jude Children's Research Hospital (SJCRH), 7 at MD Anderson, and 1 at Rady Children's Hospital. Twenty-three participants met stratum A eligibility, 2 met stratum B1 eligibility and 4 met stratum B2 eligibility.|
752389|NCT00539539||
752390|NCT00539526||
752391|NCT00539513||
752392|NCT00539500|The study was activated in October of 2007 and, due to slow accrual, was closed in December 2010. All recruitment done at UT MD Anderson Cancer Center.|
752393|NCT00539305||
752394|NCT00539279||
752395|NCT00539253|"January, 2008 to May, 2012
~People with hepatocellular carcinoma who were candidates for TACE who were referred to Johns Hopkins Hospital."|none observed
752396|NCT00539240|Recruitment from GI clinic in VA medical center between 4/19/2006 and 3/31/2010|Eligibility screening occurred prior to randomization. Of 236 patients enrolled, 68 patients were not randomized due to abnormal endoscopy (14 patients), asymptomatic during run-in period (2 patients), lost to follow-up (11 patients), consent withdrawal, protocol deviation and screen failure (32 patients) and other causes (9 patients).
752397|NCT00539188||
752398|NCT00539110||
752399|NCT00539032|Participants were enrolled from 30 September to 03 November 2007, at 4 health centers in Saudi Arabia.|A total of 238 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
752400|NCT00539006||
752401|NCT00538980||
752402|NCT00538915|First subject enrolled: 24 September 2007. Last subject completed: 24 July 2009. 15 investigative sites, hospital clinics and private physician clinics.|This was an open study. All enrolled subjects received study medication.
752403|NCT00538902||
752404|NCT00538863|The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.|Five patients who completed the titration period did not start the maintenance period due to failure to determine a dose in the titration period (n=1), withdrawal from the study (n=3), and adverse event (n=1).
752405|NCT00538850||As there are dozens, if not hundreds, of cross-over sequences during the double-blind period of this study, instead of reporting participant flow for each of the cross-over sequences, participant flow is reported separately for the fentanyl and placebo groups.
752406|NCT00538824||
752407|NCT00538785|A total of 1236 subjects were randomized at 162 sites in 16 countries within the northern hemisphere between 21Oct2005 and 14Dec2005 in Season 1 and 02Oct2007 and 31Dec2007 in Season 2; each subject participated in the study for a single RSV season.|Subjects were randomized 1:1 on Study Day 0 to receive either 15 mg/kg motavizumab or 15 mg/kg palivizumab. A permuted-block randomization method was used and a separate randomization schedule was generated for each site and cyanotic CHD strata combination.
752408|NCT00538759||
752409|NCT00538733||
752410|NCT00538681||
752412|NCT00538629||Subjects enrolled had to have taken at least 1 dose of 40, 60, or 80 milligrams of ziprasidone. The study included subjects with diagnosed Type I or II bipolar disorder with manic and mixed episodes (n=223) and subjects with schizophrenia of up to moderate severity, either first diagnosed or repeated episodes (n=248).
752413|NCT00538616|Subjects approached if they had indwelling Licox catheters and were given sedation.|Study started at onset of shift with 1 hour washout between crossover. One subject taken off sedation prior to enrollment because they were no longer eligible
752414|NCT00538590||
752415|NCT00538512||
752416|NCT00538473||
752417|NCT00538434||
752418|NCT00538304||
752419|NCT00538291||
752420|NCT00538213||
752421|NCT00537979|Participants were enrolled into the study at 12 dialysis centers in Mexico. Recruitment began in September 2007 and ended in January 2010. The study population consisted of patients on hemodialysis or peritoneal dialysis with a diagnosis of secondary hyperparathyroidism.|
752422|NCT00537940|Overall, 561 participants were screened and 482 participants participated in the study; 242 participants were randomized but one participant from the pregabalin group and one participant from the gabapentin group were not treated. Hence 241 participants were treated in each treatment group. Participants were randomized at 56 centers.|One participant from the pregabalin group and one participant from the gabapentin group were randomized but not treated.
752423|NCT00537823|The study opened to participant enrollment on 06/06/2007 and closed to participants enrollment on 11/03/2009.|
752424|NCT00537810||
752425|NCT00537771|Patients were enrolled in 28 centres in the People's Republic of China. FSI: 18Sep2007; LSI: 28 Feb2009;LSLV:20 Dec 2011.|A total of 384 patients were screened (informed consent signed and CRF started) and 353 patients were randomized with 175 patients in the Tamoxifen group and 178 in the Arimidex group.
752426|NCT00537745|Subjects were initially recruited from only two local Ignition Interlock providers. Recruitment was expanded by placing advertisements in local free press venues and flyers at all local Ignition Interlock providers.|
752427|NCT00537680||
752428|NCT00537576|Between November 2007 and January 2008, 12 participants were recruited through advertising in health centers, educational institutions, community bulletin boards and online forums.|All 12 enrolled participants completed the study.
752429|NCT00537511||
752430|NCT00537485||
752431|NCT00537446||
752432|NCT00537407||
752433|NCT00537394|Subjects recruited between February 2008 and May 2011 from participating ACTG, IMPAACT, and ATN network sites located in the continental US and Puerto Rico.|A total of 104 exclusions among 517 enrolled to active screening but prior to assignment and dispensation of study treatment were due to any of the following: no resistance/tropism test results, not willing to accept any ARV study regimens, changes to current PI based ARV regimen or non-adherence, or changes with respect to eligibility criteria.
752434|NCT00537381||
752435|NCT00537329||Approximately 100 eligible subjects from 22 centers were planned to be enrolled. However, due to slow enrollment, 46 subjects were screened and 43 subjects were assigned to treatment.
752436|NCT00537316||2 participants were randomized but not treated. Part 1: 237 participants received ≥1 dose study medication. Part 2: Of 108 enrolled/randomized participants, 95 continued assigned treatment from Part 1 and 13 were randomized and entered into Part 2 of the study (10 participants from Part 1 and 3 participants who were enrolled directly into Part 2).
752437|NCT00537303|A total of 67 centres in 12 countries participated: Denmark (1), Finland (6), France (5), Netherlands (6), Norway (5), Russian Federation (4), Serbia (2), South Africa (3), Spain (5), Sweden (3), United Kingdom (7), United States of America (20)|Eligible subjects were included in a 12-weeks forced titration period with insulin detemir as add-on to current oral anti-diabetic drug (OAD) treatment. Those subjects who did not meet the HbA1c target below 7% were then randomised to one of the two treatment regimens. Any use of sulphonylurea was discontinued at the time of randomisation.
752438|NCT00537290|Patients who were ≥18 years of age, did not have other systemic autoimmune diseases, and fulfilled at least one of the laboratory criteria and one of the clinical criteria were eligible for inclusion in the study.|Laboratory criteria defined as positive results of a LAC test, positive aCL IgG/IgM/IgA isotype (≥40), and/or positive anti-β2GPI IgG/IgM/IgA isotype (≥40) on 2 or more occasions, at least 12 weeks apart. Clinical criteria defined as 1)persistent thrombocytopenia 2)Cardiovascular disease 3)skin ulcer 4)aPL nephropathy 5) cognitive dysfunction.
752439|NCT00537277|One single site in Turkey|Eligible subjects were those with type 2 diabetes inadequately controlled with oral anti-diabetic drugs (OADs) with or without basal insulin therapy.
752440|NCT00537238||
752441|NCT00537199|Recruitment Period: 06/04/07 through 06/22/07. Single participant recruited at UT MD Anderson Cancer Center although multi-center study.|Only 1 patient enrolled prior to sponsor Zila Biotechnology terminating study. Study monitoring done by sponsor; no final data available on part of University of Texas (UT) MD Anderson Cancer Center.
752442|NCT00537095|From September 28th, 2007 to October 16th, 2008, 145 patients were randomized by 16 centers in 7 European countries to receive vandetanib 300 mg once daily oral dose or placebo.|The main reason for non-randomisation was non-respect of eligibility criteria
752443|NCT00537082||
752444|NCT00537056|Seventeen previously untreated adult patients with advanced stage IV renal cell carcinoma (RCC) were prospectively recruited to Stanford Hospital and Clinics for a baseline PET/CT scan followed by a 12-month follow-up PET/CT scan post sunitinib therapy.|
752445|NCT00537030||Confirmation of the patient ineligibility was not confirmed by the COG study team until the patient received their first dose of Erwinia. Patient was removed from the COG frontline study (AALL08P1) prior to enrollment of this study.
752446|NCT00537017|Participants from Study P04501 (NCT00406029) were enrolled into this study (Treatment Phase [TP] and Follow-up Phase [FUP]).|Screening for entry into the TP was performed over an 8 day period.
752447|NCT00536991||
752448|NCT00536978|Recruitment Period: September 26, 2007 to April 24, 2009. All recruitment done at UT MD Anderson Cancer Center.|Of the 22 patients enrolled in the study, none were eligible to receive the adback T-Cell or Natural Killer (NK) cells.
752449|NCT00536939||This study consisted of a safety lead-in prior to randomization. The study was terminated prior to completion of safety lead-in period.
752450|NCT00536913|137 subjects enrolled; 30 non randomised: 26 failed inclusion criteria, 2 voluntary discontinuations, 1 incorrect enrolment, 1 adverse event. 107 subjects were randomised|
752451|NCT00536874||
752452|NCT00536809|This was a Phase I/II study. Enrollment of Phase I was complete; however, Phase II of the study was terminated early due to lake of interest by sites in participating. Only 2 of the 15 planned participants were enrolled prior to termination.|
752453|NCT00536744||
752454|NCT00536731|898 subjects enrolled; 156 not randomised: 94 incorrect enrolment, 9 adverse events, 18 voluntary discontinuations, 1 lost to follow-up, 1use of not allowed medication, 1 non-compliant|
752455|NCT00536575||
752456|NCT00536510|"Phase III
~First Patient In: 10-May-2007
~Last Patient Last Visit: 11-Mar-2008
~42 Outpatient centers in China (21), Hong Kong (2), India (11), and Korea (8)"|Asia-regional lipid study with patients 18-70 yrs, including diabetic patients +/- statin, without ischemic vascular disease and LDL-C<130 mg/dL (3.37 mmol/L), patients on a statin with ≥2 risk factors with LDL-C ≥130 and ≤160 mg/dL (3.37 and 4.14 mmol/L), and patients +/- statin with ≤1 risk factor with ≥130 and ≤190 mg/dL (3.37 and 4.92 mmol/L).
752457|NCT00536484|Participants were screened at 90 centers in the United States; in 88 centers, participants were randomized.|The study consisted of a 2-week no-treatment screening period and a 12-week double-blind treatment period. Participants with bothersome overactive bladder (OAB) symptoms who met all entry criteria at baseline (end of screening) were randomized.
752458|NCT00536471||Study HMFS comprises two identical trials (identified as Group A and Group B). Study Period I was a screening period. Study Period II was a 9-month double-blind treatment period. Study Period III was an optional double-blind 2-week discontinuation/taper period.
752459|NCT00536380||
752460|NCT00536341||
752461|NCT00536263||
752462|NCT00536198|Three-center study; New Haven, CT; New York City, NY; Richmond, VA. Participants recruited via direct mail and advertisements. Assessed initially over phone, then face-to-face screening office visit. Screening took place between September 2007 and February 2012.|
752463|NCT00536172|298 patients were screened for possible study eligibility from January 6, 2008, to December 28, 2011. 160 subjects agreed to participate.|12 of the 160 subjects who agreed to participate were not eligible: 9 QIDS or QIDS-C >/=11; 1 not able/willing to return for follow-up; 1 received antidepressants in the past week; 1 not diagnosed with epidermoid cancer and meets MINI criteria for depression. The remaining 148 subjects were randomized.
752464|NCT00536120|Participants were enrolled in the study at 10 investigational sites in the US. Study enrollment began on 07 January 2008.|
752465|NCT00536107|A total of 14 patients with locally advanced or metastatic non small cell lung cancer of adenocarcinoma histology previously treated with one platinum based chemotherapy were screened and randomized.|
752466|NCT00535938||
752467|NCT00535925||Out of patients originally enrolled in our study cohort, 538 patients with negative history of cardiovascular events were considered eligible and 111 further added from three new centers. 189 patients from 10 clinics were excluded prior to randomization due to their refusal to participate, 65 individuals due to change of either center or residence
752468|NCT00535873|Recruitment Period: 10/3/2007 through 7/10/2009. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.|Sixty-one participants were registered and signed consent for this study. One participant signed consent but never received study medication.
752469|NCT00535847|Subjects randomized to placebo control group in parent studies VX05-950-104 (NCT00336479), VX05-950-104EU (NCT00372385) and VX06-950-106 (NCT00420784) who had discontinued treatment in the parent study due to an inadequate response to treatment or relapsed after treatment were eligible to participate in this study VX06-950-107 (NCT00535847).|
752470|NCT00535821||
752471|NCT00535782||
752472|NCT00535769|participants must be >18 yo, own a cellular telephone with text-message features, and know how to retrieve text messages.|
752473|NCT00535743|Of the N=174 randomized participants, N=173 received treatment. Treated participants are counted as Started in the arm that most accurately describes the treatment received. If no treatment was received (N=1 participant), participants are counted as Started in the arm to which they were randomized.|N=2 participants (randomized to Arm O) received (rec'd) 8 mg/kg Sugammadex, 3 minutes (min) after 1.2 mg/kg Esmeron® and are counted as Started/Treated in Arm P. Further, N=1 participant (randomized to Arm Q) rec'd 12 mg/kg Sugammadex, 29 min after 1.2 mg/kg Esmeron® and is counted as Started/Treated in Arm W.
752474|NCT00535730|"Phase III
~First subject enrolled on 18-Jun-2007.
~Last subject enrolled on 05-Dec-2007.
~The last subject's last visit was 11-Feb-2008.
~The study was conducted at 18 study centers throughout Canada, Australia, and Europe."|
752475|NCT00535652||
752476|NCT00535626||241 patients/245 hips - 51 patients/52 hips censored = 190 patients/193 hips followed
752477|NCT00535613||
752478|NCT00535587||
752479|NCT00535496||
752480|NCT00535405|"Phase III
~First Patient In 08-Nov-2007; Last Patient Last Visit 23-Mar-2009
~Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease 65 years and older."|The study evaluated patients ≥ 65 years of age at moderately high or high risk for Coronary Heart Disease (CHD), with or without atherosclerotic vascular disease. The study was a 3-week single-blind placebo run-in period and a 12-week active treatment period where patients were equally randomized to one of 5 treatment groups for 12 weeks
752481|NCT00535392|Subjects were recruited from sites in the United States, Belgium, Germany, France, Mexico, and Turkey. The study began in September 2007 and continued until February 2010, with the last subject's visit occurring in February of 2010.|
752482|NCT00535301|Subjects were recruited from the Female Pelvic Medicine and Reconstructive Surgery Clinic at Kaiser Permanente Bellflower Medical Center between January 2005 and April 2006.|Exclusion criteria were less than stage II anterior vaginal prolapse, current or future pregnancy, prior grafted anterior prolapse repair, impaired wound healing, known hypersensitivity to polypropylene, unable or unwilling to give valid informed consent or if scheduled to undergo concomitant Burch colposuspension or pubovaginal sling.
752547|NCT00531011|The patient population was comprised of male and female patients derived from the general interventional cardiology population from 9 centers in Italy.|
752483|NCT00535288||946 participants were randomly assigned in this study, however, one participant assigned to placebo never received treatment and one participant assigned to placebo actually received esmirtazapine 18 mg and is included in that group for all study analyses.
752484|NCT00535262|20 patients recruited from DES outpatient population with Bipolar Depression, ages 18-65.|Hypomania/mania requires treatment with mood stabilizer for at least two weeks; must be anti-depressant-free for two weeks (six weeks for fluoxetine.
752485|NCT00535236|Autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants, participants with solid tumor malignancy (STM) and receiving chemotherapy, and participants with hematologic malignancy (HM) were enrolled in the study.|
752486|NCT00535223|170 male, Vietnam era veterans referred for PTSD treatment were informed about the study, 98 consented to participate, 11 dropped out before randomized, 6 were excluded due to (3)psychosis or manic symptoms and 3 did not have PTSD. 40 were assigned to PSGT and 41 to GBET. One assigned to GBET, dropped out during the first week and was replaced.|Participants had been referred to an outpatient PTSD program, were first screened by the staff of that program and if judged to be appropriate for intensive PTSD treatment were informed about the study. They could request to be screened for the study or go directly into one of the treatments provided by the PTSD program.
752487|NCT00535145|One-hundred-twenty-one (121) participants were enrolled but only 114 entered Phase 1 of the study (5 participants enrolled twice and only had their first entrance included and 2 participants did not sign the required HIPAA form).|
752488|NCT00535132||
752489|NCT00535002|Cocaine-dependent and control males and females between the ages of 18 and 65 were recruited between July 2008 and July 2012. Participants were primarily recruited through newspaper advertisements, and study procedures were conducted in the Clinical Neuroscience Division and Clinical and Translational Research Center of MUSC.|A total of 400 people consented to study participation; 171 met study inclusion criteria. 115 people completed study procedures, and the data of 112 subjects was included for analysis. Data from two participants were excluded from analysis because it was discovered later that they did not meet eligibility requirements.
752490|NCT00534976||Of the 364 participants screened for inclusion, 298 participants were excluded during screening and were not randomized. The remaining 66 participants met inclusion criteria and were randomly allocated to one of the two treatment sequences.
752491|NCT00534937|Recruitment occurred at medical clinics. The first subject was enrolled in November 2007. The subjects were recruited from current patient populations and new patients coming to the clinic. Advertisement materials were used to increase enrollment with little success.|
752492|NCT00534833|Participants were randomized and enrolled from 21 September 2007 to 03 December 2007 in 2 clinical centers in the Philippines.|A total of 362 participants who met the inclusion but not the exclusion criteria were enrolled and vaccinated.
752493|NCT00534794||
752494|NCT00534703||
752495|NCT00534638|Immunization phase (Day 0 to Month 12) = adolescents (birth cohorts '92-'95) were vaccinated with Cervarix/Engerix-B. Effectiveness evaluation phase (Visit 5) = the vaccine's impact was assessed on female subjects aged 18.5. At Day 0, Cervarix was not licensed for males;male subjects receiving the vaccine were considered part of a Phase III trial.|34412 subjects were enrolled in the study, out of which 2236 subjects had a subject number allocated, but did not receive a vaccine dose, and 1 subject was excluded due to non-eligibility criteria, hence 32175 subjects were vaccinated and started the study.
752496|NCT00534599|Patient enrollment from 31 August 2007 to 02 September 2008|Wash-out period of up to 35 days for discontinuation of prohibited medications
752497|NCT00534495||71 participants enrolled. 1 participant was erroneously randomized and was not included in the analysis. This patient was not exposed to study drug
752498|NCT00534417|5 community oncology research sites across the US associated with ACORN participated in this study. Enrollment started in February 2008 and was completed in May 2010.|Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
752499|NCT00534404||Interested individuals completed a screening survey to determine eligibility. Following study consent, participants completed two emailed surveys over the next two days and a phone confirmation call before being randomized. These check-ins confirmed the participant had valid contact information and maintained their desire to quit smoking.
752500|NCT00534365||A total of 281 patients were enrolled. Of these, 18 patients withdrew prior to randomization (including for the following reasons- cancelled surgery (6), did not meet inclusion criteria (4), declined further participation (8)).
752501|NCT00534352|The 42-day open-label main treatment phase of this trial was conducted from 10 December 2007 to 27 May 2008. Four investigators from the US participated in this multicenter trial. A total of 35 subjects were screened and of these, 23 subjects entered the trial and started the first treatment phase|
752502|NCT00534313||191 participants were enrolled and 21 were not randomized. Reasons for this included: adverse events (AEs) (2); participant withdrew consent (5); lost to follow up (1); participant no longer meets study criteria (13).
752503|NCT00534248||
752504|NCT00534235||
752505|NCT00534209||
752506|NCT00534118||
752507|NCT00534105|Pregnant patients presenting for gestational diabetes screening|Only uncomplicated obstetrical patients
752508|NCT00534092||
752509|NCT00534001||
752510|NCT00533949||
752511|NCT00533910||
752512|NCT00533897|Participants with Rheumatoid Arthritis (American College of Rheumatology Class I, II or III) were enrolled. Study initiated November 2007. Short Term (ST) results and some long term extension (LTE) results up to a database lock in 2010 were released earlier. Study concluded February 2014. Final LTE results are now included.|270 participants enrolled; 167 were treated in the Short Term (ST) study. 103 were not treated (10 withdrew consent, 2 lost to follow-up, 91 no longer met study criteria). ST study included 3 Periods: Lead-In (LI), Doubleblind Withdrawal (DBW), and Reintroduction (RI).150 participants entered the LTE study.
752513|NCT00533845|1 participant randomized to bupivicaine did not complete the study because the participant had to be returned to surgery prior to commencement of study procedures|
752514|NCT00533702||Participants who completed the study were those who died or were alive but off treatment at the end of the study.
752515|NCT00533546|The recruitment period spanned the following dates: October 2007 through July 2010. Location of recruitment and enrollment was in the emergency department of approved sites for patients presenting with acute ischemic stroke. Of the 9 participating sites, 3 actively enrolled.|No patients were excluded after enrollment.
752516|NCT00533507||
752517|NCT00533442|From September 1, 2000 through December 15, 2009, 170 consecutive patients with type 1 diabetes and ESRD were randomized to receive either Rapamycin (N=84) or MMF (N=86) immediately prior to transplant. Post-transplant clinical follow-up of patients continued through January 15, 2011.|A randomized block design was implemented for the randomization scheme using Proc Plan in SAS. Patients were randomly assigned (allocation ratio of 1:1) to the two treatment arms in blocks of 4 and 6 patients (block sizes were also chosen randomly), ensuring a balance of patients across treatment arms after each block of patients was randomized.
752518|NCT00533351||There were 2 Treatment Periods in this Cross-Over Study. Patients randomized to AGN201781 during Period 1 received Placebo during Period 2. Patients randomized to Placebo during Period 1 received AGN201781 during Period 2. Period 3 was an Observational Period only (No treatment provided).
752519|NCT00533273||
752520|NCT00533117|Participants were recruited from the emergency department, clinician referrals and advertisements. Recruitment period ended 6 months prior to study end date.|91 participants signed consent, 86 were randomized, 11 participants dropped out prior to treatment start. Therefore 75 participants remained, accounting for the discrepancy between the original 91 participants and the final count of 75. Participants were washed out of all psychotropic medications. Benzodiazepine is permitted for sleep.
752521|NCT00532948|All participants in the study were enrolled at Pediatric Brain Tumor Consortium (PBTC) institutions in the United States of America (USA), from 24 May 2007 through 27 October 2009.|The study consisted of two periods of dosing: A dose-finding treatment period of 11 weeks and a post radiation treatment phase that lasted for 9 weeks.
752522|NCT00532935|"First Patient In: 19-Mar-2008
~Last Patient Last Visit: 23-Oct-2009
~Seventy-four medical clinics worldwide (19 sites in the United States, 31 in Eastern Europe, and 24 in the rest of the world)."|"Patients 18-78 years old with Type 2 Diabetes Mellitus (T2DM), drug-naïve (off antihyperglycemic agent
~[AHA] for at least 3 months prior to screening, and a maximum 4 weeks cumulative AHA therapy over the
~previous 3 years), hemoglobin A1C 7.5 to 12% were eligible. Eligible patients underwent a 2-week placebo
~run-in period prior to randomization."
752523|NCT00532883|Subjects were recruited from October 2006 through June 2008 at 10 sites across the United States. Subjects were recruited from sickle cell specific clinics.|Subjects were screened to ensure specific laboratory measurement levels after enrollment but prior to randomization.
752524|NCT00532779||
752525|NCT00532493||
752526|NCT00532480||
752527|NCT00532441||
752528|NCT00532298||Two subjects enrolled in this study were not vaccinated and as such not accounted for under Started.
752529|NCT00532259|22 February 2008 (first patient enrolled) to 02 June 2011 (last patient completed) The study was carried out in medical centers|
752530|NCT00532155||A total of 1130 participants signed an informed consent to enter the study. Amongst these, 913 were randomized to the two arms in this study. 217 participants were screen failures.
752531|NCT00532129||
752532|NCT00531960||
752533|NCT00531947|Male and female adolescent subjects between 12 to 17 years of age diagnosed with moderate to severe major depressive disorder were screened over an approximate two year period at 26 investigative sites in the U.S.|
752534|NCT00531934||
752535|NCT00531882|Subjects were recruited from lab personnel and CF Center employees and UH employees and by word of mouth. Due to the vulnerability of this population every effort was made to avoid coercion. No one was enrolled that was directly supervised by the PI. The recruitment log was kept in a secure location in the CF Team Office.|Inclusion and exclusion criteria were reviewed at screening. Concomitant medications were reviewed prior to randomization. Subjects were excluded if they were on NSAIDS, corticosteroids (including inhaled steroids and statin lowering medications.
752536|NCT00531843|During a 6-month period, consecutive adults presenting to one Level I urban trauma center were screened for eligibility, enrolled and assigned to a treatment category using previously-developed clinical guidelines.|Of 105 enrolled participants, 18 were excluded from analysis (13 discharged or transferred prior to second venous ultrasonography; 4 received non-study DVT prophylaxis; 1 had a known protein-C deficiency).
752537|NCT00531817||
752538|NCT00531752||
752539|NCT00531661||
752540|NCT00531518||
752541|NCT00531479||Participants were stratified at study entry for host and transplant variables known to have an independent impact on the probablity of death due to invasive aspergillosis (IA) (allogenic hematopoietic stem cell transplant versus other, and pulmonary IA).
752542|NCT00531453|98 patients were enrolled between October 2007 and September 2008|All enrolled patients received at least one dose of study drug.
752543|NCT00531427|27-Sep-2007 (first patient first visit) to 28-Apr-2009 (last patient last visit) at 83 medical/research sites in US|Open-label run-in period designed to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). N = 1151 entered the run-in period, and N = 571 completed. One subject was not dosed, therefore N = 570 randomized. N = 3 subjects did not have safety data, therefore N = 567 had double-blind data.
752544|NCT00531284|"Patients with relapsed solid tumors (non-small and small cell lung, ovarian, renal, any other solid tumor type), multiple myeloma or lymphoma were enrolled at 7 sites in the US.
~Under the original protocol patients received a bolus intravenous (IV) infusion of carfilzomib; patients enrolled under Amendments 2 to 4 received a 30-minute IV infusion."|Phase 1b followed a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD). For Phase 2 (bolus), a Simon 2-stage design was planned using the MTD from phase 1b. The first stage of the Simon's 2-stage design was carried out; however, the study did not progress to the second stage.
752545|NCT00531206||
752546|NCT00531050||The study was double blind with regard to the administration of indacaterol and placebo and open label with regard to salmeterol. The study had 2 parts. Each Part of the study consisted of 3 treatment periods separated by a minimum of 7 days. The two parts of the study were separated by a minimum of 7 days.
752548|NCT00530946|Twenty (20) centers in Japan|A total of 301 subjects entered the 6-week diet observation period and the end of diet observation period, 165 subjects who met all the inclusion criteria for the treatment period and had no conflict to exclusion criteria were randomized to 4 CI-1038 groups.
752549|NCT00530920||
752550|NCT00530894||
752551|NCT00530855|This Multicenter, Open-Label Study started to enroll Subjects in February 2008.|Participant Flow refers to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
752552|NCT00530842|All participant flow data are presented by treatment sequence|
752553|NCT00530816|This study enrolled patients with multiple myeloma (MM) who had relapsed or refractory disease after at least 1 but no more than 3 prior therapeutic treatments or regimens. The first patient enrolled on 24 September 2007; the last patient was enrolled and received carfilzomib on 28 May 2009.|"Two groups of patients with MM were initially studied: bortezomib-treated (Part 1) and bortezomib-naïve (Part 2). Following Amendment 2, only bortezomib-naïve patients were enrolled. With Amendment 3, a new cohort of stepped up dosing was added to the trial. Study results were analyzed in 2 parts, based on previous bortezomib treatment."
752554|NCT00530803|Children, ages 4 - 12 , who had outpatient clinic visits between June 2007 and August 2008 at an urban, tertiary care hospital and required venipunctures for medical care were recruited for this study.|
752555|NCT00530790||
752556|NCT00530777|HIV-1 infected pregnant women seeking antenatal care at the Mathare North City Council Clinic in Nairobi Kenya, or referred from neighboring clinics, were recruited for study screening|
752557|NCT00530764||
752558|NCT00530712||
752559|NCT00530634||
752560|NCT00530621||Presented in the participant flow are the reasons participants discontinued from study treatment.
752561|NCT00530504||
752562|NCT00530439||
752563|NCT00530348|Participants were screened at 101 investigational sites in Argentina, Australia, Brazil, Canada, Croatia, the Czech Republic, France, Germany, Mexico, Poland, Russia, Serbia, Sweden, Ukraine, the United Kingdom (UK), and the United States (US) between August 28, 2007 and April 27, 2011.|
752564|NCT00530335||
752565|NCT00530270|Subjects were recruited from October 2006 through June 2008 at 10 sites across the United States. Due to the acute nature of the disease under study, subjects were recruited in a hospital, frequently in the Emergency Department.|No events excluded patients following enrollment, but prior to group assignment. Group assignments were made at enrollment.
752566|NCT00530257|Participants were recruited from an outpatient ADHD evaluation and treatment program at a pediatric academic medical center. Eligible children wer: 1) Age 6-12 years and at least in 1st grade; 2) DSM-IVTR diagnosis of ADHD, Combined Type;3) Parent and teacher ratings on the ADHD Rating Scale-IV > 85th percentile; 5) IQ greater than 75|Parents of 41 patients inquired about participating in the study. Four did not meet eligibility requirements leaving 37 eligible children. Three families elected not to participate leaving 34 children. Three children did not complete the dose finding stage leaving 31 children who entered the double blind placebo controlled crossover study.
752567|NCT00530218||
752568|NCT00530088||
752569|NCT00530075|The study was conducted at 7 sites in 6 European countries from 2003 to 2006|
752570|NCT00530023||
752571|NCT00529958||
752572|NCT00529802|A total of 60 patients started trial between December, 2007 and June, 2010 at 5 clinical sites. . A total of 63 patients signed consent, (1 withdrew consent, 2 failed screening)|This is a single-arm trial.
752573|NCT00529789||Period I was a 2-week Screening/Washout Phase. Period II was a 10-week Dose-Titrating with Pharmacokinetic Sampling Phase. Period III was an 8-week Safety and Tolerability Phase. Period IV was a 3-month Extended Safety and Tolerability Phase. Period V was a 2-week Taper Phase. Results presented are for combined Periods II/III and Period IV.
752574|NCT00529763||A total of 140 participants were enrolled in the study. 121 received at least 1 dose of dasatinib. Of the 19 participants who were enrolled but not treated, 15 withdrew consent, 3 no longer met study criteria, and 1 refused to enter treatment phase.
752575|NCT00529659|Participants were randomized from 28 sites (2 sites in Mexico, 10 sites in South America, 8 sites in Europe, 5 sites in Asia Pacific, and 3 sites in South Africa).|After a 2-week placebo run-in period, patients were randomized in a 1:1 ratio to receive treatment with either oral MK-0773 50 mg twice daily or matching placebo.
752576|NCT00529633|The study has been terminated due to lack of participation. We enrolled 16 subjects according to eligibility. 4 subjects randomized into the study. Two subjects completed the study.|"Subject enrollment into the active study must meet capsule count of >85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program"
752577|NCT00529568||The number of enrolled participants in the protocol record (n=759) reflects the number of participants randomized to double-blind treatment after completing the Open-label Phase.
752578|NCT00529555||
752579|NCT00529542|Participants were recruited through the clinics of the Departments of Medicine and Obstetrics and Gynecology at Penn State Hershey Medical Center from October 20, 2006 to September 8, 2008.|
752580|NCT00529529||
752581|NCT00529516||
752582|NCT00529464|Recruitment Period: 11/08/06 through 05/01/08. All participants recruited at UT MD Anderson Cancer Center.|Two patients were recruited, both ineligible, with no research related procedures performed. Study terminated early due to low enrollment.
752583|NCT00529451||
752584|NCT00529399|The original recruitment goal was to enroll 126 subjects. However, additional eligible subjects were identified during the screening process and 145 subjects were enrolled in the study.|
752585|NCT00529386||
752586|NCT00529373||
752587|NCT00529308||
752588|NCT00529282||
752589|NCT00529243|A multicenter study that enrolled patients from 11 Kaiser Permanente Human Immunodeficiency Virus (HIV) clinics in California. 54 patients were screened. Two patients did not meet protocol inclusion criteria.|
752667|NCT00525876|Recruitment Period:1/27/2005 through 8/31/2010. All participant recruitment attempted at UT MD Anderson Cancer Center.|Out of the 49 participants enrolled, 13 were excluded, not assigned to part of the two intervention study groups.
752590|NCT00529217|Participants were recruited from the Brain Behavior Clinic of Columbia Psychiatry and the Depersonalization and Dissociation Program of Mount Sinai and Beth Israel Medical Centers in New York.|No enrolled participant was excluded from the trial. Twelve outpatients entered the study.
752591|NCT00529204||
752592|NCT00529191|Patients were recruited from medical clinics at CHOP from July 2007- January 2010|
752593|NCT00529152||
752594|NCT00529126||
752595|NCT00529100||A total of 16 participants entered Phase 1 of the study. A total of 39 participants were analyzed in Phase 2, which included data from 6 Phase 1 participants.
752596|NCT00529087|Patients were recruited worldwide from August 2007 to September 2008.|Patients were screened up to 16 days.
752597|NCT00529035||
752598|NCT00528970|Postoperative participants (who had undergone repair of large [at least 10 centimeters] ventral hernias, with or without mesh prosthesis via laparotomy or laparoscopy) were randomized in 1:1:1 ratio to either MOA-728 24 mg, MOA-728 12 mg, or placebo treatment groups.|Participants were prospectively stratified by type of surgery (laparotomy or laparoscopy) and geographic region.
752599|NCT00528957|Participants were enrolled at study sites in the United States, Panama, and the United Kingdom. The first participant was screened on 28 December 2006. The last study visit occurred on 16 August 2017.|127 participants were screened.
752600|NCT00528931||
752601|NCT00528879||Of 915 participants enrolled, 562 completed a qualification period. Of these 562 participants, 546 were randomized and received treatment and 16 were excluded due to adverse events (1), no longer meeting study criteria (7), poor compliance or noncompliance (3), withdrawn consent (4), and lost to follow-up (1).
752602|NCT00528866||
752603|NCT00528840||
752604|NCT00528801|Patients with HB SS/SB0 were recruited from 12 sickle cell centers from Dec 2004 through May 2008. To eliminate selection bias, all eligible patients at these centers were approached. Matched peer controls of African descent were recruited from patients' community-based churches or neighborhoods, and matched for gender, age and education.|The NP Battery and the MRI could be scheduled in either order. A 4 week visit window was set between screening and the first of the two procedures. An additional 4 week window was set between the first procedure and the second.
752605|NCT00528788|We prospectively enrolled 24 hemodialysis patients with secondary hyperparathyroidism into an open-label 30-day observational study.|Participants underwent review of history and meds. Hemodialysis (HD) blood was drawn. seen in vascular laboratory for testing of endothelial cell function and arterial stiffness. Doxercalciferol was initiated at dose of 2 mcg IV 3x/wk or 4 mcg IV 3x/wk. After 30 days of medication, repeat blood drawn and repeat testing in vascular laboratory.
752606|NCT00528775||
752607|NCT00528645|24 patients were enrolled from 13 medical clinics from February 5, 2008 to August 21, 2008.|One patient cancelled prior to treatment initiation and is excluded in the analysis.
752608|NCT00528606||
752609|NCT00528580|Patients enrolled 2008-2009 at University of Chicago and Mercy Hosptial in Chicago, IL|
752610|NCT00528567||
752611|NCT00528541||
752612|NCT00528528||Out of 166 participants who were randomly assigned to treatment, only 161 participants received the study treatment.
752613|NCT00528450||
752614|NCT00528424||
752615|NCT00528411||
752616|NCT00528398||
752617|NCT00528372||Of 1067 participants enrolled, 558 received treatment in the Short-term Period. Of those 558 participants, 469 entered the Long-term Period.
752618|NCT00528268||
752619|NCT00528190||
752620|NCT00528112||
752621|NCT00528021||
752622|NCT00527982|Recruitment Period: September 29, 2005 to December 18, 2007. Patients were recruited at UT MD Anderson Cancer Center.|One patient registered determined to be inevaluable. Trial termination due to poor accrual and study program redesign.
752623|NCT00527943|Prior to the planned study completion, the Data Safety Monitoring Board recommended that all participants stop treatment and that the study be closed-out. The protocol-defined target number of primary efficacy endpoints had been reached by this time. However, follow-up in the study was terminated earlier than planned.|The Intent to Treat (ITT) Population, defined as all enrolled participants who were randomly assigned to a treatment group.
752624|NCT00527904|Multi-center US study, 58 sites recruited between October 2007 and March 2009|Screening for eligibility and wash-out of restricted medications
752625|NCT00527878||16 participants were screened but only 14 participants were randomized. Two individuals decided not to participate.
752626|NCT00527826||
752627|NCT00527787|A multi-center US study in which 59 sites recruited subjects between September 2007 and September 2008|Screening for eligibility and wash-out of restricted medications
752628|NCT00527748|26 participants were enrolled. While we know the number who completed the study (23), we do not know to which group/arm they were assigned. There are no other recruitment details, study results or data available as the PI left the institution without making this information available to the research department.|
752629|NCT00527735||Of 334 participants enrolled in this study, 331 received treatment. One patient with nonsmall-cell lung cancer, randomized to the sequential arm but mistakenly treated with concurrent therapy, is included in the sequential arm for efficacy results and in the concurrent arm for safety results.
752630|NCT00527722|Recruitment Period: September 12, 2005 to February 21, 2008. All recruitment done at UT MD Anderson Cancer Center.|Participants who met the eligibility criteria (77 participants) were consented into study while another set of criteria had to be met for randomization. Only 47 participants met the randomization criteria.
752631|NCT00527644||
752632|NCT00527618|We recruited HIV-1/HSV-2 coinfected patients in Seattle, WA, between January 2008 and June 2010.|Of 49 persons screened, 15 were found to be ineligible for reasons including lack of HSV-2 infection (n=5), plans to initiate ART (n=3), undetectable plasma HIV-1 RNA (n=3), neutropenia (n=2), elevated hepatic transaminases (n=1), and incarceration (n=1). The remaining 34 participants were randomized.
752633|NCT00527605||
752668|NCT00525837||
752815|NCT00517751|Due to early study termination, the final analysis is consistent with the last annual report submission to the FDA and data reported on FDA's post-approval webpage reporting on 162 of 176 enrolled subjects.|
752816|NCT00517699||
752634|NCT00527592|Patients were recruited from two US glaucoma specialty clinics from 6/8/2007 to 8/13/2008. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension in both eyes were enrolled.|54 patients were enrolled in the study. Qualified patients ceased prostaglandin use for 3-5 days (wash-out) prior to Visit 2 (randomization).
752635|NCT00527566||
752636|NCT00527514|Participants were recruited at 18 US sites over 4 months (September 2007 to December 2007) from each physician's clientele base. Approximately 150 eligible participants, men and women at least 18 years of age with hypertension or uncontrolled hypertension on current medication, were to receive active treatment|After placebo treatment, participants with a mean systolic blood pressure (SBP)≥140 mmHg and ≤199 mmHg or a mean diastolic BP (DBP)≥90 and ≤109 mmHg with a difference between mean SBPs ≤15 mmHg and a mean 8-hr daytime SBP of ≥135 mmHg and ≤199 mmHg, and mean 8-hr daytime DBP of <110 mmHg by ambulatory BP monitoring were considered eligible.
752637|NCT00527488||
752638|NCT00527475||
752639|NCT00527423|This study was conducted at 35 sites in the United States that participated in the Phase 1 and Phase 2 studies VGFT OD-0502 (NCT00320775), -0508 (NCT00320788), or -0603 (NCT00383370). The recruitment period occurred between 19 Oct 2007 and 29 Oct 2008.|One hundred fifty seven participants were eligible if they had neovascular Age-related Macular Degeneration (AMD) and completed dosing in the Phase 1 and Phase 2 studies VGFT-OD-0502 (NCT00320775), -0508 (NCT00320788), or -0603 (NCT00383370). For each subject, only one eye was designated as the study eye.
752640|NCT00527397|10 centers in Japan.|As a result of Pfizer's decision (18 Oct 2007) to return the worldwide rights for CP-464,005 (insulin human [rDNA origin] Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study before it had recruited targeted number of subjects.
752641|NCT00527332||
752642|NCT00527319|First patient visit: March 23, 2007 Last patient visit: December 10, 2008|
752643|NCT00527124|Subjects were recruited from the outpatient clinics or inpatient service of Karmanos Cancer Center by physicians in the Department of Hematology and Medical Oncology, between December 2007 and December 2011.|57 subjects went on study; an additional 27 subjects were consented, 23 were not eligible to go on study, 4 withdrew from study.
752644|NCT00527111||
752645|NCT00527098||
752646|NCT00527072|A total of 217 subjects enrolled into the study but 2 subjects did not receive any study medication so they were excluded from analysis.|
752647|NCT00526994|May, 2009-April, 2010 at 10 primary health care clinics in Chicago|8 Unenrolled: 7 because computer did not save baseline data & 1 Withdrew
752648|NCT00526890||
752649|NCT00526799||
752650|NCT00526669|68 participants were enrolled in the study, as reflected by the enrollment number in the protocol record; however, one participant elected to not receive study treatment and was thus not included in the Intent-to-Treat Population.|After an initial tumor biopsy (biop.), participants (par.) received lapatinib monotherapy in a 7-day Run-in Period, followed by a second biop. After the second biop., par. received a 14-day course of capecitabine in combination with lapatinib, which continued in the absence of treatment-related toxicity, until disease progression or withdrawal.
752651|NCT00526656|Eleven patients were entered into the trial between 9/07 and 12/09 from medical clinic. Two patients were considered ineligible and received no treatment.|
752652|NCT00526630|Twenty-three subjects with PD and moderate gait impairment were enrolled for this 6-month placebo-controlled, double-blind study.|
752653|NCT00526591||
752654|NCT00526474|Prior to planned study completion, the Data Safety Monitoring Board (DSMB) recommended discontinuation of study drug in all participants with a pre- or post-randomization history of stroke. A total of 4510 participants had study medication stopped, however these participants were included in the overall population for efficacy and safety analyses.|The Intent to Treat (ITT) Population, defined as all enrolled participants who were randomly assigned to a treatment group.
752655|NCT00526331|Recruitment Period of August 8, 2007 to June 30, 2008 at UT MD Anderson Cancer Center. Study recruitment done at medical clinics.|Study terminated by sponsor responsible for multi-center data collection and reporting. No data collection or analysis completed.
752656|NCT00526292||
752657|NCT00526227||
752658|NCT00526188|The recruitment period was 20 Aug 2007 to 30 Aug 2008.|247 Chinese patients were recruited and screened. Among these, 13 patients were screening failures: withdrawal of consent (7 patients), non-fulfillment of the inclusion and exclusion criteria (3 patients), other reasons (3 patients). The remaining 234 patients received the study drug and were included in the safety analysis set.
752659|NCT00526162||
752660|NCT00526123|Patients with ESRD requiring hemodialysis via a chronic hemodialysis catheter at least 3x weekly for a minimum of 6 weeks were recruited from the clinical study sites. Participating sites included hospitals and private medical clinics. Subjects were enrolled from September 2007 through January 2011|Patients that met all of the eligibility criteria were enrolled and were randomized 1:1 to either the symmetric tip or split-tip catheter group. Enrolled subjects were further stratified via subject ID by new catheter insertion versus catheter exchange.
752661|NCT00526110|Recruitment Period: September 8, 2004 to August 5, 2009. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.|
752662|NCT00526097|Participants were partly recruited by commercial research centers and partly by general practitioners.|Participants were randomised into the treatment period only, when functional constipation and compliance with rescue medication were confirmed by eDiary data in the two-weeks baseline period without study medication.
752663|NCT00526071|An open label, long-term extension study for participants who completed one of 4 preceding Phase 2 studies (FAB-CL-201 [NCT00214500], FAB-CL-202 [NCT00283959], FAB-CL-203 [NCT00283933], or FAB-CL-204 [NCT00304512]). Participants could enter this study directly upon completion of the previous study or at a later point.|This study included a dose escalation period (DEP), in which migalastat was administered at 250 milligrams (mg) for 2 months. If there were no safety concerns the dose was increased to 500 mg for up to 10 months, depending on the date of amendment approval. Before and after the DEP, all but 1 participant (post-DEP 300 mg instead) received 150 mg.
752664|NCT00526058||
752665|NCT00525915|Recruitment Period: April 01, 2005 to June 20, 2011. All recruitment done at UT MD Anderson Cancer Center.|
752666|NCT00525902||
752817|NCT00517634||
752669|NCT00525824|Eight hundred thirty-three patients (with hypercholesterolaemia and CHD or CHD risk equivalent, atherosclerosis or a 10-year CHD risk of >20%) were randomized into the study, from 111 sites located in the United States (56), Peru (13), Netherlands (12), Colombia (8), Argentina (8), Brazil (6), Chile (4) and Lithuania (4).|Patients underwent screening procedures (Week -6; Visit 1), and entered a 6-week dietary lead-in period. Those who fulfilled all eligibility criteria (Week -6; Visit 1) and had qualifying lipid values at Visit 2 were randomly allocated (1:1:1:1) to 1 of 4 treatments for a period of 12 weeks.
752670|NCT00525798|"Patients were enrolled at 16 centers in 12 countries:
~3 centers in the US and 3 centers in Denmark.
~1 center in Brazil, Estonia, Czech Republic, Poland, Lithuania, Romania, Italy, France, Hong Kong, and China.
~First patient randomized: 26 Feb 2007 Last patient visit: 30 Jul 2011"|
752671|NCT00525785|Recruitment Period: January 13, 2004 to October 25, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.|
752672|NCT00525733||
752673|NCT00525629||
752674|NCT00525603|Recruitment Period 6/24/2005 to 6/21/2007. All participants were registered at The University of Texas M.D. Anderson Cancer Center.|Of the 60 enrolled, 60 eligible participants were included in this study and started study drug.
752675|NCT00525590|Participants took part in the study at 12 sites in the United States from 12 December 2007 to 01 December 2010.|A total of 82 participants with metastatic brain cancer were screened, of which 69 participants were enrolled and 59 participants were treated.
752676|NCT00525525||
752677|NCT00525512||
752678|NCT00525499||
752679|NCT00525421|23 patients with symptomatic oral lichen planus (OLP) presenting to the oral medicine clinic at the University of California, San Francisco (UCSF) between October 2007 and November 2008 were screening for this study.|3 patients had elevated liver enzymes at baseline and were excluded prior to randomization
752680|NCT00525265||
752681|NCT00525174|Eligibility criteria included age 3 to <10 years, visual acuity in the amblyopic eye 20/40 to 20/80, fellow eye visual acuity of 20/40 or better, interocular acuity difference of 3 or more lines, and the presence or history of strabismus and/or anisometropia.|At enrollment, subjects were required to have been wearing spectacles with optimal correction for a minimum of 16 weeks or until stability of visual acuity was documented (no improvement in amblyopic visual acuity at 2 consecutive visits at least 4 weeks apart).
752682|NCT00525161|11 patients were recruited from the University of Kentucky Markey Cancer Center from November 2009-November 2011.|
752683|NCT00525148||
752684|NCT00525135||
752685|NCT00525044|Male or female outpatients, 18 to 65 years of age, suffering from acute viral pharyngitis and throat pain of at least severe intensity were to enter the trial.|Double-blind, randomized, placebo-controlled parallel design in comparison of two arms
752686|NCT00525031|Recruitment Period: August 31, 2006 to May 10, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.|Three participants of 55 enrolled were excluded due to ineligibility prior to assignment to groups.
752687|NCT00524940|Participants were recruited from 15 August to 24 September 2007 at one US clinic site.|A total of 124 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
752688|NCT00524771||
752689|NCT00524745|"21 schools were (1) matched according to size, urban/rural location and ethnicity; (2) assigned to one of four groups; and (3) randomized to one of four schedules
~All girls 11-13 years of age in these schools were eligible to participate."|
752690|NCT00524680||Total 148 patients were treated but only 128 patients were eligible for study outcome analysis.
752691|NCT00524589||
752692|NCT00524576||
752693|NCT00524537|A total of 6 participants less than 18 years of age were enrolled in the study. Participants were permitted to re-enroll after discontinuing the study. Of the 2811 participants who discontinued study, 339 re-enrolled in the study; 102 participants discontinued from the study after re-enrollment.|
752694|NCT00524511|September 4, 2007-July 9, 2010 Recruitment occured in the medical clinics and Labor and Delivery unit of an academic medical center|The study design dictates that patients be enrolled upon admission to Labor and Delivery. Subsequently, patients who did not deliver by cesarean delivery would be excluded
752695|NCT00524485|Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.|
752696|NCT00524472||
752697|NCT00524459||
752698|NCT00524420|The study was conducted between January 2008 and November 2010. Subjects were recruited from advertisements, referrals, and from a University of Washington clinic that specializes in Fibromyalgia.|493 subjects were screened over the phone. 31 subjects came into the clinic for an initial screening visit. Subjects were allowed to maintain stable doses of medication and psychotherapy. 12 of the screened subjects did not meet criteria for randomization. The remaining 19 were randomized, and 18 completed the study.
752699|NCT00524394|Recruitment using NICU ADMISSION LIST.|
752700|NCT00524368|One hundred thirteen investigators in 21 countries participated in this study.|In total 1092 participants were screened, of which 590 participants were randomly assigned and treated (294 participants were treated with DRV/rtv 800/100 mg once daily, and 296 participants with DRV/rtv 600/100 mg twice daily.
752701|NCT00524342||
752702|NCT00524316||
752703|NCT00524303||
752704|NCT00524264||
752705|NCT00524225||
752706|NCT00524173||The enrollment number in the Protocol Section (35) conflicts with the number of participants Started in the Participant Flow module (32). Two participants failed screening and one participant declined participation after enrollment and prior to beginning treatment.
752707|NCT00524134|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.|
752708|NCT00524121||
752773|NCT00520351|Study completion date is August 2008|Washout for 2 to 3 days following screening (wear spectacles only).
752774|NCT00520299||
752775|NCT00520286||
752776|NCT00520234||
752709|NCT00524043|The study began on 21 September 2007 when the first patient was enrolled and ended on 20 November 2008 when the last patient left the study. The study was performed at medical clinics in the United States, India, and Taiwan.|Patients who wished to enter the study were screened and, if necessary, had prohibited medications (such as other antipsychotic drugs) washed out for 3 to 5 days before beginning the study. Eligible patients were excluded prior to beginning the study if, for example, they took a prohibited medication.
752710|NCT00524030||
752711|NCT00524017|Study enrolled patients with premalignant lesions of the Head and Neck with mild, moderate or severe dysplasias|16 participants did not have biopsy proven dysplasia as required by protocol and were not randomized to treatment.
752712|NCT00523991||
752713|NCT00523978|Investigators at 26 sites in the United States and Canada, enrolled and randomized a total of 245 study subjects, during the 21 months trial period, between 10 October 2006 and 30 June 2008.|
752714|NCT00523939|Recruitment June 2006 - September 2008. Study stopped early due to poor accrual.|
752715|NCT00523848||
752716|NCT00523809|Recruitment Period: August 30. 2007 through November 2, 2010. All recruitment was done at UT MD Anderson Cancer Center.|
752717|NCT00523744||
752718|NCT00523718|Subjects with selective serotonin reuptake inhibitor(SSRI)-refractory OCD were recruited through the Yale OCD Research Clinic between November 2006 and December 2012 using print and internet advertisements, community outreach, and physician referrals.|Forty subjects with treatment-refractory OCD were consented; 1 dropped out after consent, and one was excluded after it was revealed they were not taking an SSRI. These individuals were not randomized.
752719|NCT00523705|The recruitment period was from 01/25/08 to 07/07/09. The study was conducted in an academic research unit. 54 females signed consent for the study at visit 1. 43 were ineligible during the screen period and 11 were randomized to double-blind treatment.|During the screen period of 2 menstrual cycles, subjects rated daily symptom diaries to indicate the presence and severity of premenstrual symptoms. A total premenstrual score >80 in each cycle was required for randomization.
752720|NCT00523640|30 patients were enrolled in the trial between March 2005 and May 2008|
752721|NCT00523614|Identification started in spring 2007 and ended in January 2008. Cases (VTE=venous thromboembolism diagnosed in Germany between 01/2002 and 01/2008) were identified by primary care physicians. For each case 4 community-based controls (no VTE between 01/2002 and 01/2008) were selected.The controls were identified from randomly selected households.|
752722|NCT00523549||
752723|NCT00523419||
752724|NCT00523367|A flyer was posted in the pulmonary clinic which provides basic information about the trial and instructs the reader to ask their doctor for more information. Interested patients were referred to the Gastroenterology Clinic where they were consented and screened.|Eligible patients with a known diagnosis of COPD and pulmonary function testing meeting criteria were asked to complete a validated GERD and quality of life questionnaire. These questionnaires are queried for GERD symptoms and an assessment of overall health during the previous year.
752725|NCT00523341|This was an extension study open to participants who had completed core study 20030216 (NCT00089791). The study was conducted at 178 centers in North America, South America, Europe, Australia, and New Zealand. Participants were enrolled from 7 August 2007 to 20 June 2008.|All participants received open-label denosumab during this study. Results are reported by the Study 20030216 randomized treatment groups (placebo versus denosumab).
752726|NCT00523302||
752727|NCT00523237|Fourteen patients, all men, were enrolled.|All screened patients were enrolled into the study
752728|NCT00522951||A total of 175 participants were enrolled into the study. 10 were withdrawn from the study before entering Study Period 1. Safety Analysis Set included 164 participants; gadobutrol=161, ProHance=162. Per Protocol Set (PPS) included 151 participants.
752729|NCT00522925||
752730|NCT00522873|Only non-hysterectomized, postmenopausal women could take part in this study. The women had to have symptoms requiring hormone therapy in the opinion of the investigator. An endometrial biopsy at screening was to show no evidence of endometrial hyperplasia or cancer.|944 women screened, 661 treated. 282 failed screening: consent withdrawn (55), in-/exclusion criteria not met (209), lost to follow-up (3), other (15). 1 woman was randomized but not treated (own decision). 5 women completed the study but not study medication, i.e. they stopped medication early but remained in the study for final assessments.
752731|NCT00522795|Accrual closed in August 2009, 40 patients were enrolled|
752732|NCT00522626|Enrollment occured between May 2006 and May 2009 from a drug treatment facility treating pregnant and postpartum drug dependent women|
752733|NCT00522548|Recruitment occured at the Hospital of the University of Pennsylvania March 2007-June 2010. Living donor kidney recipients were approached in clinic at pre-transplant visit (within 30 days or less of transplant. Recipients of deceased donor kidney transplants were approached inpatient at transplant or 2 days thereafter.|Patients were not randomized until they were transplanted.
752734|NCT00522457|Open-label phase 2 study evaluating the efficacy and safety of ertumaxomab for the treatment of metastatic breast cancer tumors. Ertumaxomab will be administered 3 times at 7 day intervals by constant rate 3 hour intravenous (IV) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day 7±1)and 100 µg(day14±1)(flat doses).|Patients were required to complete screening procedures and up to five treatment visits.
752735|NCT00522431||Of 406 participants screened, 149 met the inclusion/exclusion criteria and entered the study.
752736|NCT00522418|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. There were 9 screen failures out of 131 screened patients, leaving 122 patients who started the study and are described in the Participant Flow.|Patients were randomized in a 1:1 ratio to the Best Medical Practice With Adjunctive VNS Therapy study group or to the Best Medical Practice Without VNS Therapy study group. VNS Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.
752737|NCT00522392|Participants were recruited from ECOG member institutions between September 6, 2007 and May 7, 2010.|
752812|NCT00517933||
752813|NCT00517881||
752814|NCT00517829||
752856|NCT00515177|Participants were recruited through newspaper, radio advertisements and Internet.|
752857|NCT00515112||
752738|NCT00522379|"This Phase III study started in July 2007 with subjects from the United States, Mexico, Peru, Chile, and India. The primary completion date and study completion date occurred in July 2011.
~The Participant Flow and Baseline Characteristics are represenative of the Safety Set (SS), which is 514 subjects."|"The study outcome measures are representative of the Full Analysis Set (FAS), which is 502 subjects.
~The Full Analysis Set (FAS) consisted of all subjects who were randomized, received at least 1 dose of study medication, and had a valid Baseline primary efficacy measurement and at least 1 valid post-Baseline primary efficacy measurement."
752739|NCT00522301||
752740|NCT00522275||
752741|NCT00522171||
752742|NCT00522041||
752743|NCT00521989||
752744|NCT00521976|Consecutive recruitment at Stavanger University Hospital.|
752745|NCT00521924|Due to poor enrollment rate, this trial was terminated prematurely. Eight patients had been enrolled from June 2007 to April 2008: 4 in each arm.|
752746|NCT00521885|Unable to recruit suitable subjects is the reason this study was terminated early|one patient was a screened failure- after consent found to have an exclusion criteria during screening
752747|NCT00521599||
752748|NCT00521586||Initially 1060 participants were reported to complete the 6 month follow up at Year 0, however 6 additional participants who were reported to have withdrawn initially, actually completed the 6 month follow up at Year 0.
752749|NCT00521456||
752750|NCT00521404|A total of 65 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 12 clinic sites in the United States of America. Three (3) of the participants were not treated with the study drug. The data on the 62 treated participants are presented in this report.|Three participants were enrolled but later failed entry criteria. They did not receive treatment and were not included in this analysis.
752751|NCT00521365|Type I Bipolar Disorder in manic phase with a YMRS (Young Mania Rating Scale) score ≥12 at study entry. Patients of both genders, 18 - 65 years old, with bipolar disorder I according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria.|
752752|NCT00521352|Patients were recruited between January 2008 and December 2010 from the Brain Behavior Clinic and the Anxiety Disorders Clinic of New York State Psychiatric Institute/Columbia University.|No enrolled participant was excluded from the trial. Twenty-five patients were recruited.
752753|NCT00521339|Participants must have had a diagnosis of plaque-type psoriasis for at least 6 months and had an insufficient response, were unresponsive, intolerant of, or had medical contraindications to standard systemic therapy or biological treatment for plaque-type psoriasis. The study was conducted at 4 sites in the U.S. from 20 August 2007 to 12 May 2009.|The study consisted of a 12-week treatment phase, a 12-week treatment extension phase and a 4-week observational follow-up phase. Participants could enter the follow-up phase at any time during the study. Some participants had completed the study before the extension phase was added and therefore never had the opportunity to participate.
752754|NCT00521144|Protocol Open to Accrual 8/7/2007 Primary Completion Date 8/10/2010 Recruitment Location at medical clinic|
752755|NCT00521079||
752756|NCT00521053||
752757|NCT00521014||
752758|NCT00521001||
752759|NCT00520975|Ninety-six patients were randomized between November 9, 2007 and October 28, 2009 when the trial closed due to slow accrual.|
752760|NCT00520936||
752761|NCT00520910||
752762|NCT00520884||Seventeen women were screened. Ten qualified - five had unintentional weight loss of >5% in the prior year plus at least 2 out of the 4 remaining Fried criteria for frailty and five healthy women without any frailty criteria. Women with conditions that can cause weight loss or taking an appetite stimulant or corticosteroids were excluded.
752763|NCT00520845|This study opened October 2007 and ran to December 2013. All patients were recruited from Vanderbilt-Ingram Cancer Center.|"This study included a run-in phase of celecoxib 600 mg BID x 5-7 day, following patient enrollment. Patients with ≥70% decrease in PGE-M level, were considered COX dependent and protocol eligible making them eligible for protocol treatment. Patients with <70% decrease in PGE-M level were not eligible."
752764|NCT00520767||
752765|NCT00520741|"The study was conducted at 160 sites in the United States of America (USA), Canada, Europe, and Australia.The maximum duration of a subject's trial participation is 30 weeks.
~The Participant Flow refers to the Safety Set (SS) population which consists of all patients who received at least one dose of study medication."|Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
752766|NCT00520676||Analyses were conducted on the qualified intent-to-treat population (Q-ITT) unless otherwise specified. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
752767|NCT00520572|The first participant enrolled on 01 August 2007, the last participant completed the study on 08 April 2009. Participants were recruited from 59 centres in 12 countries in Australia, Canada, Europe, Russia, South America, and the USA.|Male/female participants with active rheumatoid arthritis (and on background methotrexate or sulphasalazine) were randomly assigned to receive AZD9056 at 50, 100, 200 or 400 mg once daily, placebo or etanercept. It was planned to randomise approximately 360 participants, 60 to the open-label etanercept arm and 300 to the AZD9056 or placebo arms
752768|NCT00520546|Enrollment of first patient: 18th. December, 2007 Completion by last patient: 12th. January, 2011 Single Center Study at Federal Armed Forces Hospital Ulm|44 patients were enrolled, 38 patients completed the study. 1 patient decided not to choose prostatectomy after Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI), although it was planned at point of enrollment. 5 patients did not get a PET/MRI-can because of failed radiopharmaceutical synthesis of [18F]fluoroethylcholine (FEC).
752769|NCT00520494||
752770|NCT00520481||Participants who had results for the primary outcome measures were considered to have completed the study. The primary outcome measure is: Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab.
752771|NCT00520468|Recruitment Period 6/15/04 - 6/1/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.|Of fifteen patients enrolled, fourteen patients registered were evaluable and one patient taken off study never having received study drug.
752772|NCT00520403||
752777|NCT00520130||There were 89 participants in the study. 3 patients enrolled and their cancers progressed prior to randomization so they were taken off study. 3 of these participants went back into remission with additional chemo and were re-enrolled on the protocol and randomized. They are counted twice in the enrolment (e.g. 92) but only once in the Started row.
752778|NCT00520039|Recruitment dates: September 2007 through May 2009 Site: medical clinics of 2 colleges of osteopathic medicine Location: mid-Atlantic and Northeast areas of the United States|52 subjects were enrolled and randomized into the two study groups. 5 subjects in the SCO group and 7 subjects in the SC+OMM group were excluded from the study due to having a normal tympanogram on the first study visit.
752779|NCT00520013|Sixty patients were enrolled between Aug 3, 2007 and Jan 6, 2010.|Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.
752780|NCT00519896||
752781|NCT00519831||18 patients were enrolled, 2 patients were consented but not enrolled. 1 patient withdrew and 1 patient was taken off the study due to decline in performance status.
752782|NCT00519818||
752783|NCT00519779||
752784|NCT00519649|"One additional subject, enrolled but not vaccinated, was not included in the number of subjects under STARTED"|
752785|NCT00519636||
752786|NCT00519623|Subjects for the IN2007001 study were recruited between August 2007 and November 2007 by the Phase 1 Clinical Research Unit.|Subjects stopped intermediate/long-acting insulin 48 hours prior to treatment or discontinued use of their insulin pump when they arrived for the treatment. There was a run-in period in which IV insulin lispro was administered to achieve a glucose clamp target of 100 mg/dL prior to application of the patch.
752787|NCT00519584||
752788|NCT00519532|A total of 84 subjects belong to the Enrolled Set (ES) and all of them received at least 1 dose of trial medication, so they all belong to the Safety Set (SS). 83 subjects belong to the Full Analysis Set (FAS).|Participant Flow information belong to the Enrolled Set (ES). Baseline Characteristics are described for the Full Analysis Set (FAS).
752789|NCT00519428|Recruitment dates: August, 2007 to August 2011 Locations: 4 outpatient research clinics in two countries (US and Canada)|All patients had to be psychoactive drug-free for at least two weeks (five weeks for fluoxetine) prior to randomization and had to continue to meet study entry criteria at point of randomization
752790|NCT00519376||Participants meeting eligibility criteria at screening were randomized and entered a treatment period. Participants were then randomized to 4 treatment periods in one of 16 sequences (seq) each lasting 1 day and separated by a 7 - 14 day washout period.
752791|NCT00519285|Between August 2007 and February 2010, a total of 1548 patients gave informed consent for this study.|Amongst these patients, a total of 324 were screening failures (primarily due to non-compliance with exclusion criteria) and did not get randomized.
752792|NCT00519194||
752793|NCT00519090||
752794|NCT00519077||
752795|NCT00518986|55 centers in the US. First participant enrolled: October 2007/ Last participant last visit: March 2009|The study consisted of a 1-week single-blind, placebo run-in screening period followed by a 12-week double blind treatment period. Of the 249 patients enrolled, 248 patients received at least 1 dose of study drug and were evaluated for safety; 1 patient who was assigned to receive armodafinil was lost to follow-up before taking any study drug.
752796|NCT00518973||Of these 21, 15 were randomized and began the drug; the other six participants failed the in-person screening phase.
752797|NCT00518882|A total of 133 centres in 15 countries: Austria (4), Denmark (6), Finland (5), France (5), Germany (14), Ireland (4), Macedonia (1), Norway (4), Poland (9), Romania (3), Slovenia (3), Spain (4), Sweden (2), Switzerland (4) and United States (65).|Eligible subjects were subjects with type 2 diabetes being treated with oral anti-diabetic (OAD) therapy(ies) for at least 3 months prior to the study. Three subjects were exposed to study drug prior to randomisation, and thus only included in safety analysis set.
752798|NCT00518713||
752799|NCT00518687||
752800|NCT00518622|"This study was conducted at 11 sites in the US and 1 site in Germany.
~Date of first patient visit: 6-Jul-2007; Date of last patient visit: 5-Sep-2008."|To be eligible for enrollment into this study, all patients must have met a number of laboratory criteria including, but not limited to, the presence of hepatitis C virus (HCV) ribonucleic acid (RNA) and HCV genotyping.
752801|NCT00518531|First subject enrolled 03-Oct-07, last subject enrolled 25-Jun-08; First subject crossovered 22-May-08, last subject crossovered 25-Jun-09;|
752802|NCT00518349|120 patients, routinely referred for outpatients colonosciopy, were randomized 1:1 to examination with protototype or standard colonoscope.|Exclusion criteria were pregnancy, age younger than 18 years, previous resection for colorectal disease and inability to comprehend the information given.
752803|NCT00518336||Out of the five subjects withdraw at Year 7, three subjects came back during Year 8 and are therefore not longer considered as withdraw subjects. At Year 9, one subject, who did not participate to Year 7 and Year 8 visits, came back for one of the visits and was added to Total cohort.
752804|NCT00518323|Recruitment started 8 August 2007 in medical clinics located around the world. The study ended on 30 March 2009.|Subjects who were eligible for the study had their current disallowed psychotropic medications washed out prior to assignment to treatment groups. Subjects who violated inclusion criteria before assignment (eg, because they continued to take a disallowed medication) were to be removed from the study.
752805|NCT00518284||
752806|NCT00518206||
752807|NCT00518180|Participants were enrolled at a single center in Costa Rica.|All enrolled subjects were randomized at a 1:1:1 ratio to receive the MenACWY vaccine when given alone and concomitantly with the Tdap vaccine and the HPV vaccine at different schedules.
752808|NCT00518154||
752809|NCT00518115||A total of 361 participants were randomized into the study; however, only 356 of these participants received at least one dose of study drug.
752810|NCT00518089||
752811|NCT00518011|A total of 17 chemo-naïve participants with Non-Small Cell Lung Cancer (NSCLC) Stage IIIB with pleural effusion or stage IV and a Eastern Cooperative Oncology Group performance status 2 (PS 2) were recruited. The study was conducted from 24 August 2007 to 14 February 2009 at 14 Centers in Australia.|Total 17 participants were enrolled; however the data was available for 16 participants. One participant in the gemcitabine arm withdrew consent before receiving treatment.
752818|NCT00517595|9 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in August 2007 and was completed in September 2009.|Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
752819|NCT00517556||
752820|NCT00517530|Different patients were recruited into Phase I and Phase II, and analyzed separately based on their disease. In this adaptive trial design, some of those same patients were included in follow-up even if they did not complete treatment, and 13 who had initially responded to treatment but subsequently progressed were retreated.|
752821|NCT00517413|A total of 261 participants were screened and 163 participants were enrolled from 26 centers in 9 countries (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay, Venezuela) from 08 October 2007 to 15 May 2010.|
752822|NCT00517361||
752823|NCT00517296||
752824|NCT00517192||
752825|NCT00517075|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|
752826|NCT00517010||
752827|NCT00516919|The study enrolled participants from August 2007 through October 2009. Participants were a consecutive series of 79 monolingual (Spanish-speaking-only) obese Latino/as recruited from clinical teams and referrals at a community mental health center serving economically disadvantaged persons with mental health needs.|
752828|NCT00516906|The study population included adult males and female patients with an existing, or newly inserted, catheter that was to remain in place for at least 3 days, who were willing to participate in the study, and who would provide informed consent and sign a consent form. First patient enrolled 10 October 2007. Last patient enrolled 20 December 2007|No Wash out. No run-in
752829|NCT00516893||
752830|NCT00516737|Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany)|Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.
752831|NCT00516503||Two-hundred eight patients were enrolled to this study. Five patients cancelled prior to initiating protocol treatment and were therefore this study was analyzed using 203 remaining patients.
752832|NCT00516386|Sixteen anorexia nervosa patients between the ages of 12-18 years were recruited. Patients were determined by their psychiatrists to meet criteria for AN as described in the Diagnostic and Statistical Manual of Mental Disorders (a).|Four subjects were not interested in the study after the screen, and two were lost to follow-up.
752833|NCT00516321||
752834|NCT00516295||
752835|NCT00516269|Recruitment Period: 03/11/2005 to 03/23/2011. All participants were recruited at UT MD Anderson Cancer Center.|Participants were randomized to receive methylphenidate-placebo or placebo-methylphenidate. Of the 42 enrolled: 33 completed the study + 4 completed partial visits + 1 randomized to placebo twice (38 total), excluded were three who did not meet criteria (not randomized), and one who withdrew consent.
752836|NCT00516217|Between June 2008 and January 2009, 30 patients were recruited.|One patient never received treatment and is excluded from all analyses.
752837|NCT00516165||
752838|NCT00516139||The study consisted of 4 phases (Ph): 7-week (w) Dose-escalation Ph, 8-w Adjunctive Maintenance (AM) Ph, 13-w Adj. Optimization (AO) Ph or 13-w Conversion/Monotherapy (C/M) Ph, and a 2-5 w Taper/Follow up (T/F) Ph.
752839|NCT00516074||
752840|NCT00516048|Following a period of treatment interruption of at least 2 months, patients for this study were recruited from among patients who were previously exposed to exenatide for at least 3 months in Amylin/Lilly studies GWAO, GWAP, GWAT, and GWBA.|
752841|NCT00515879|Prospective participants were recruited between September 2007 and June 2011 through referrals to the three study sites (Boston University [BU], Massachusetts General Hospital [MGH], and Southern Methodist University [SMU]), from other area clinical facilities and programs, and from advertisements.|Study participants underwent a two-step screening evaluation, consisting of 1) telephone screening, and 2) psychiatric assessment and medical history taking with physical examination.
752842|NCT00515827||
752843|NCT00515723|Participants were recruited from wide range of sites in the St. Louis community. Some advertising with flyers was used however the majority of the recruitment was done using community outreach,doctor-to-doctor or self-referrals, and referrals from board and care and community support programs. All recruitment materials were approved by the IRB.|Participants were enrolled in the study once they signed consent. After enrollment, participants were brought in for a screening visit consisting of a diagnostic interview, screening labs, a review of records and a discussion with their primary psychiatrist. If the patient met all inclusion criteria after screening, study visits were scheduled.
752844|NCT00515697||This study comprised 3 study periods: pretreatment, treatment, and (posttreatment) follow-up. 40 participants signed the informed consent.
752845|NCT00515671||
752846|NCT00515619|The study was started in December of 2004 with recruitment occurring in Australia, Croatia, Czech Republic, Finland, France, Germany, Hungary, Lithuania, Poland, Russia, Spain, Sweden, and the United Kingdom. The study had last patient last visit in August of 2010.|Safety Set consists of all subjects who received at least 1 dose of Lacosamide.
752847|NCT00515541|The study was conducted at the Carolina Center for Clinical Trials at the University of North Carolina at Chapel Hill campus. Enrollment period: 9/24/07 through 10/13/08.|
752848|NCT00515528||
752849|NCT00515502||Participants were randomized to receive a sequence of 4 of 5 possible treatments over 4 treatment periods each separated by a washout period of at least 14 days. Participants were randomized to receive treatments in 12 possible sequences.
752850|NCT00515463|"Patients who successfully completed Study 20050141 (NCT00330460) were eligible to participate in this study.
~First Subject Enrolled: 30-May-2007 Last Subject Enrolled: 10-Sep-2007"|
752851|NCT00515437|24 centers were initiated to screen and enroll subjects. Enrollment began in July 2007 and completed in March 2008. 54 subjects were enrolled at 17 centers|
752852|NCT00515411||
752853|NCT00515294|Recruited via newspaper ads and social media.|
752854|NCT00515216|This study opened to participant enrollment in June 2008 and closed to participant enrollment in October 2010.|
752855|NCT00515203|Participants were enrolled from 19 Jul 2007 through 11 November 2008|
752858|NCT00515099|Subjects were recruited during an approximate 40-month accrual period. Initially 66 subjects were planned, however enrollment closed early at 58 subjects on June 30, 2011 secondary to slow accrual (planned 30-month accrual period).|Subjects ages 12 to 35 years who were first diagnosed with type 1 diabetes mellitus (T1DM) within 100 days of enrollment.
752859|NCT00515086||Eligible participants were separated into 2 Groups: Group 1 (Surgery Group) patients were scheduled for salvage surgery and randomly assigned to one of 3 pre-surgery treatment groups: 0, 5 or 10 mg/day Everolimus for 7 days. Group 2 (No Surgery Group) patients were not scheduled for salvage surgery and received 10 mg/day Everolimus.
752860|NCT00515073|Recruitment Period: April 30, 2001 to November 18, 2009 with actual enrollment occuring October 2001 through July 2009 at University of Texas (UT) MD Anderson Cancer Center and MD Anderson Cancer Center Orlando.|Two participants of 32 were enrolled but not included in group assignment due to ineligibility.
752861|NCT00515034||
752862|NCT00515021||1 participant withdrew prior to randomization
752863|NCT00515008|We conducted the trial from July 2007 through May 2009 at Tufts Medical Center, a tertiary care academic hospital in Boston.|"90 Underwent baseline evaluation. 24 Were excluded:
~1 Did not have fibromyalgia 4 Were physically unable to participate 17 Had scheduling conflicts
~1 Was currently practicing tai chi
~1 Had preexisting medical condition"
752864|NCT00514943||Open-label randomized, cross-over study. 124 patients were randomised. 3 patients were not treated, 1 in Afatinib arm and 2 in Cetuximab arm.
752865|NCT00514917|Participants were enrolled from 53 sites in North America (the United States of America and Canada) and Europe. Study was terminated after all participants had completed treatment with docetaxel, but before all participants had completed 18 months follow-up. The termination was not due to any safety or efficacy concerns.|
752866|NCT00514904||A total of 1504 subjects were enrolled into the study, and 1501 of them were vaccinated.
752867|NCT00514852||
752868|NCT00514813|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) at a dose that is appropriate for them and not to exceed 20,000 IU at any one time.
752869|NCT00514735|The first subject was enrolled on November 28, 2007. The very last ablation procedure was a retreatment ablation procedure for a Medical Management Crossover subject that occurred on May 7, 2010 with the final follow-up on November 1, 2010.|"32 subjects signed Informed Consent forms but withdrew from the study prior to randomization.
~24 failed to meet inclusion/exclusion criteria
~6 elected to withdraw
~1 subject was withdrawn by the Sponsor after being consented.
~1 subject was withdrawn as screening was incomplete prior to closing enrollment for the study"
752870|NCT00514709|Participants were randomized and enrolled from 06 August 2007 to 29 July 2008 in 2 clinic centers in the Philippines.|A total of 1843 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
752871|NCT00514683||
752872|NCT00514592||
752873|NCT00514540|All participants were enrolled between June 2006 and October 2010 at The University of Texas (UT) MD Anderson Cancer Center (MDACC).|Of the 121 participants enrolled, seven were ineligible and excluded. Another participant was eligible but withdrew before treatment.
752874|NCT00514514|.817 patients were screened and 802 were enrolled on Day of transplant which served as Baseline Visit 1. For three months post transplantation, in the pre-phase period, all patients received induction therapy (Simulect®) and immunosuppressive therapy consisting of Myfortic, Sandimmun Optoral and corticosteroids.|At month 3 post transplant, Baseline Visit 2, additional eligibility was assessed and patients randomized to one of 3 treatment arms and stratified according to kidney donor (living or cadaveric).
752875|NCT00514501||
752876|NCT00514449|Subjects were recruited between 7/2007 and 8/2009 at two separate sites, Pittsburgh and Detroit. Recruitment took place through the local hospital and community mental health and school counseling centers, as well as other research studies and area mental health conferences.|Patients first had a placebo run-in for two weeks along with the psychiatric medications they were on and then randomized at Week 2 to either VAV or placebo group. Enrolled subjects were excluded due to cannabis abuse, claustrophobia, and a duration of illness that was too long.
752877|NCT00514215||
752878|NCT00514137|Thirteen participants were accrued from September 2007 to December 2008.|All 13 participants were analyzed.
752879|NCT00514046||
752880|NCT00514020|This study was conducted from August 2007 to March 2011.|Forty-two patients signed consent, 9 of which were found to be ineligible to participate in the study.
752881|NCT00513799||
752882|NCT00513747||The Enrollment number in the Protocol Section does not match the number of participants who started in the Participant Flow due to limited data on one participant (i.e. the participant was registered but was not randomized or classified (high vs. low risk) because the participant withdrew consent for all follow-up the same day of registration).
752883|NCT00513708||
752884|NCT00513695||
752885|NCT00513682||
752886|NCT00513617|Enrolled subjects at participating sites from May 2004 through July 2007. Sites consisted of sickle cell treatment centers from across the United States.|All subjects were to be without hydroxyurea, transfusion, and arginine for 90 days prior to enrollment. Prior to randomization, blood was drawn for baseline efficacy and safety measurements.
752887|NCT00513604||"Note with amendment K patients cohorts 1-3 were closed and patients were randomized between cohorts 4 and 5.
~The difference in the cohorts is NOT aldesleukin. The aldesleukin, cyclophosphamide and fludarabine are the same for each cohort. The difference is in the TIL and in cohort 3, the addition of radiation."
752888|NCT00513526||
752889|NCT00513500||
752890|NCT00513474||
752891|NCT00513461||
752892|NCT00513435|Protocol Open to Accrual 08/22/2006 Protocol Closed to Accrual 07/14/2009 Primary Completion Date 03/08/2011 Recruitment Location is the medical clinic|
752893|NCT00513409||
752894|NCT00513370||
752977|NCT00509002|Recruitment Period: May 2004 to October 2006. All recruitment done at The University of Texas MD Anderson Cancer Center.|
752978|NCT00508924||
752895|NCT00513357|Recruitment Period: 07/21/2006 -04/08/2011. All participants recruited at UT MD Anderson Cancer Center.|Of the 125 participants, there were 52 participants excluded (43 did not meet inclusion criteria; and 9 declined to participate).
752896|NCT00513344|5 healthy subjects, 2 females and 3 males, were recruited within the staff of the Nestlé Research Center in June-July 2008.|From 3 days before the first test session no foods containing epicatechin or catechin or procyanidins should be ingested. The subjects received a single dose of the 3 products in a randomised order with a minimum of 3 days washout in between (crossover design). The duration of the study was a minimum of 15 days.
752897|NCT00513305|Seven centers in the United States and one center in Canada. First patient enrolled 12 October 2007; last patient completed protocol-specified treatment 5 July 2009; last patient completed survival follow-up contact 16 December 2009.|
752898|NCT00513292|Total Enrolled: 282, 2 patients withdrew consent before starting treatment, 280 patients started the treatment and are eligible for primary analysis.|
752899|NCT00513240|Subjects recruited from September 2006 to February 2011 in the Texas Children's Hospital Heart Center NICU and CVICU.|357 assessed for eligibility; 253 did not meet inclusion criteria. 42 subjects that eligible but consent not obtained (24 declined, 2 enrolled in another study, 16 investigator not available for consent or patient lived too far away). 62 consented, enrolled, received 1 dose EPO, but intended surgery not done on 3 subjects (no CPB); leaving 59.
752900|NCT00513071||
752901|NCT00513019|August 2007 - July 2009|
752902|NCT00512902|University setting convenience samples.|1-year, Phase I/IIa, Open-label trial
752903|NCT00512876|Participants were recruited from the Ophthalmology Service at Walter Reed Army Medical Center, Washington DC from August 2007 to January 2011|
752904|NCT00512798|This study remained open to accrual from 6/3/03 to 3/11/08.|19 participants were enrolled to the phase I portion of this trial and 28 were enrolled to the phase II portion of this trial. There were also 3 participants that were consented to take part in this trial, but were determined to be ineligible.
752905|NCT00512707||
752906|NCT00512278|"Enrollment 2007-2011 Data Lock Nov 22, 2012 Sites
~The Cleveland Clinic
~University Hospitals of Cleveland
~Cedar Sinai Medical Center, Los Angeles,
~The Liver Institute at Methodist Dallas
~Brooke Army Medical Center, San Antonio
~Advanced Medical Research Center, Daytona Beach.
~University of Louisville, Louisville"|220 subjects screened and 149 randomized Reasons for exclusion were multiple including malignancy, liver failure, negative HCV RNA, abnormal lab values, poorly controlled diabetes, psych disorders, positive tuberculosis skin test, seizure disorder, inability to get labs or liver biopsy, pregnancy, patient declining, other (cardiomypathy, MS, etc.)
752907|NCT00512252|Recruitment occurred from 07/12/2007 until 01/14/2010.|
752908|NCT00512148|7 patients were recruited between September 2007 and October 2008. Patients were recruited from 4 academic centers across the US. 1 patient withdrew consent prior to bladder biopsy and is included in the safety analysis but not in the efficacy analysis. Due to recruitment challenges, only 6 patients were implanted.|This was an open label, single arm study.
752909|NCT00512096|Recruitment period 17-AUG-99 to 15-OCT-08; all participants were recruited at MD Anderson Cancer Center|
752910|NCT00511992||
752911|NCT00511914||
752912|NCT00511901|Subjects recruited at two subacute rehabilitation facilities in Central New Jersey between October 2005 and March 2008|
752913|NCT00511875||
752914|NCT00511862|151 patients recruited from January 19, 2007 to October 7, 2009|Patients were assigned to groups on the basis of type of primary cancer - colorectal cancer; neuroendocrine cancer or non-colorectal/non-neuroendocrine. Subjects who unable to receive TheraSphere (target dose 120 Gy) due to vascular shunting to the lungs or GI tract were not enrolled in the study and did not receive yttrium 90 glass microspheres.
752915|NCT00511836|Subjects were enrolled at a single clinical study center. The first subject was enrolled in July 2007. The last subject was enrolled in May 2009.|Screening evaluations were conducted during a 1-week period. All screening evaluations were to be completed at least 2 days before randomization and dosing.
752916|NCT00511810|Recruitment started in August, 2007 at the University of Cincinnati, Medical Sciences Building.|A total of 24 patients were screened and 20 patients met inclusion criteria.
752917|NCT00511797||"Full Analysis Set (FAS) consisted of all patients who received at least one dose of study drug. Patients were analyzed as treated.
~FAS was the primary analysis set for all efficacy endpoints and safety analyses. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS who did not have major protocol deviations."
752918|NCT00511706||
752919|NCT00511667||
752920|NCT00511472||
752921|NCT00511433||
752922|NCT00511355||
752923|NCT00511342||
752924|NCT00511329||PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
752925|NCT00511238|Results of this study are reported in 2 parts, depending on whether a patient was enrolled and treated under the original protocol (referred to as 'A0') or under Amendment 1 and subsequent amendments (referred to as 'A1').|
752926|NCT00511199|This study recruited participants from Europe, Asia and Australia.|In total, 2152 subjects were randomized, of which 1613 subjects to NOMAC-E2 and 539 subjects to DRSP-EE. A total of 2126 subjects were randomized and treated, of which 1591 subjects on NOMAC-E2 and 535 subjects on DRSP-EE.
752927|NCT00511173|Subjects will be recruited from the warfarin clinic at the Creighton Cardiac Center from 7/06-6/07.|
752928|NCT00511147||
752929|NCT00511134|Participants were recruited from the Greater New Haven area and surrounding communities through targeted television, radio, and newspaper ads, fliers, and referrals from clinicians. Recruitment occurred between July of 2007 and October of 2008. Approximately 900 phone screens and 12 in-person screens were completed during the course of the study.|Major reasons for exclusion at phone screen were report of no sleep problems, use of illegal substances, psychiatric or medical exclusions, and low smoking. Major reasons for exclusion during the in-person screening process included withdrawal of informed consent, alcohol or illicit drug use, and low smoking.
752976|NCT00509028|241 Japanese paediatric patients were enrolled into the study|This was an open-label, multi-centre, long-term study in Japanese children with bronchial asthma aged 5 to 15 years, and conducted as an extension of the Phase III study D5254C00769.
752930|NCT00511108|"First Patient In: 12-Sep-2007; Last Patient Last Visit: 24-Feb-2009
~Forty-four medical clinics worldwide (17 in the United States, 20 in Europe, 4 in Australia, and 3 in Israel)."|Patients 30-65 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (fasting plasma glucose [FPG] 130-260 mg/dL [7.2-14.4 mmol/L]) on diet and exercise alone were eligible for randomization.
752931|NCT00511095||
752932|NCT00511004|Adults living in Kerala, India with Brugia malayi microfilaremia were recruited from field sites around the city of Alleppey and the study performed in the outpatient department of the TD Medical College.|
752933|NCT00510952||
752934|NCT00510887||Of the 14 subjects consented, 2 were screen failures so only 12 subjects received the study drug.
752935|NCT00510874||
752936|NCT00510835||
752937|NCT00510809||
752938|NCT00510783|Study completed|study completed
752939|NCT00510744||
752940|NCT00510718||
752941|NCT00510692|Single centre study (Polyposis Registry).|
752942|NCT00510653|Recruitment Period: March 7, 2002 to September 30, 2009. All registration was done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 73 enrolled, 27 were excluded as not eligible and one inevaluable for the study. Another four (4) participants were found to be not eligible following screening.
752943|NCT00510510||
752944|NCT00510497||
752945|NCT00510484|Subjects were recruited in 10 centers in US between November 2007 and January 2008. Before the randomization, subjects were evaluated for eligibility. They underwent a short period of up to 14 days on their usual pancreatic enzyme supplementation. Subjects were to take 4000 lipase units/g fat intake during both cross-over periods.|Two subjects prematurely withdrew before the randomization (1 withdrew consent and 1 for protocol violation). 32 subjects were randomly allocated to pancrelipase/placebo or placebo/pancrelipase. 1 subject did not complete the second period of the treatment. 1 subject was randomized twice and only the second randomization was used for analyses.
752946|NCT00510458||89 patients/96 hips - 15 patients/18 hips censored = 74 patients/78 hips
752947|NCT00510289|Patients 18 years or older with an ECOG performance status of 0-2, and adequate renal and hepatic function with a diagnosis of primary or therapy-related MDS were eligible for this study. Patients were enrolled from 2006 to 2011 at Duke and Duke Oncology Network sites. The study was closed prematurely due to poor response and patient withdrawals.|Three patients were ineligible due to the presence of AML in the BM done at the time of screening.
752948|NCT00510276|The recruitment period was from 16 August 2007 until 19 August 2008 in medical clinics.|Study Period 1 was a screening/washout period. Subjects who did not meet enrollment criteria were excluded from the trial before randomization. 584 participants entered the screening phase, 139 were screen failures. There was an optional 12-week open-label atomoxetine extension phase after the 12-week acute double-blind phase.
752949|NCT00510224|Men with prostate adenocarcinoma that had progressed despite androgen deprivation therapy were recruited for participation at one U.S. clinical site (UCSF)|
752950|NCT00510198||120 subjects were enrolled but 3 were not randomized into the study for not meeting the inclusion/exclusion criteria.
752951|NCT00510146||Study Period I (2-28 days) included screening and lead-in period for discontinuation of excluded medications at least 25 hours before day of randomization. Study Period II was 6-week, double-blind (Acute Phase) of treatment. Study Period III was 18-week, open-label extension for those who completed Study Period II.
752952|NCT00510068||
752953|NCT00509925|One single site in United Kingdom.|Eligible subjects were those with type 1 diabetes treated with insulin for at least 3 months having a body mass index (BMI) of 40.0 kg/m2 at most and a glycosylated haemoglobin A1c (HbA1c) between 7-11% qualifying for an intensified insulin treatment based on the treat-to-target concept. The randomisation target for this study was 30 subjects.
752954|NCT00509899||This was a non-randomized dose-ranging study. Participants were enrolled into the currently available cohort based on the timeframe when they entered the study.
752955|NCT00509873||
752956|NCT00509821||Completers were defined as participants who had failure event(progressive disease, death), or were off treatment or censored due to study completion. Participants completed follow-up after receiving 1 dose of study drug and a post dose efficacy evaluation.
752957|NCT00509795|The study was conducted at 164 sites in the United States and Canada. Recruitment period: 02 Aug 2007 to 15 Sep 2009.|2063 patients were screened, 1217 randomized, and 1215 included in the Safety Analysis Set (SAF). The Full Analysis Set (FAS) included 1210 patients with at least 1 post-baseline assessment. The Per Protocol Set (PPS) included 1089 patients who received ≥ 9 doses of study drug and attended ≥ 9 scheduled visits during the first year.
752958|NCT00509769||
752959|NCT00509665||
752960|NCT00509600|Recruitment Period: 05/19/04 through 03/05/09. All participants recruited at UT MD Anderson Cancer Center.|Study was terminated due to low accrual.
752961|NCT00509587||
752962|NCT00509496||
752963|NCT00509392|Recruitment from March - December 2007. Medical offices/clinics and university hospital.|
752964|NCT00509366||
752965|NCT00509288||
752966|NCT00509262||One site was identified as non-compliant with some of the requirements of Good Clinical Practice. For this reason, data from the 3 participants randomized at this site were deemed unreliable and were removed from all analyses.
752967|NCT00509249||
752968|NCT00509236||
752969|NCT00509223|Subjects for this study were recruited from 15 medical clinics located in the United States and Australia.|Subjects were presented with an Informed Consent Form (and HIPAA in USA) and assessed for eligibility based on inclusion /exclusion criteria. If all IEC met, subjects randomized 1:1. 118 subjects not included in endpoint analysis due to reanalysis of Obstructive Sleep Apnea (OSA) inclusion criteria. 298 of the 416 were included for final analysis.
752970|NCT00509197||
752971|NCT00509171||
752972|NCT00509106|Patients were recruited worldwide from July 2007 to August 2008|Patients were screened for up to 24 hours
752973|NCT00509093||
752974|NCT00509067||
752975|NCT00509041|Between September 2007 to August 2009, 46 participants were recruited.|Three (3) participants withdrew from the study before treatment initiation; therefore 43 participants were eligible for evaluation
752979|NCT00508872|Recruitment Period: 11/16/05 through 08/24/07. All participants recruited at UT MD Anderson Cancer Center.|Study terminated early due to slow accrual. Two patients recruited, both were taken off study (one at surgery and the second prior to adjuvant care).
752980|NCT00508820|First Subject Enrolled: 24Feb2005 Last Subject Enrolled: 05Jan2010|
752981|NCT00508755|Subjects were recruited through use of advertisement and by word of mouth to enter this feasibility study.|
752982|NCT00508742||
752983|NCT00508716|Recruited from inpatients at a small community Hospital March 1, 2007-July 31 2010.|
752984|NCT00508651|Participants 6 to < 12 months of age were screened prior to randomization at 8 sites in the USA. The first and last days of informed consent were 07Nov2007 and 30Jun2008, respectively. No participants were screened for Cohort 2 (1 to < 3 months of age) because the study was closed prior to enrollment into Cohort 2 for reasons other than safety.|Thirty participants were randomized into Cohort 1 between 12Nov2007 and 07Jul2008. Participants were randomized in a 2:1 ratio to receive MEDI-560 or placebo, and randomization into Cohort 1 was not stratified.
752985|NCT00508521|Subjects were recruited through the use of study flier and by word of mouth.|All subjects enrolled in the study were entered into the same arm of this pilot study
752986|NCT00508482|Recruitment ot this trial started in April 2008 and finished in Dec. 2010. Patients were recruited from clinics in each center by posters and advertisements in newspapers.|
752987|NCT00508469|Patients were recruited from 5 hospitals in Spain.|Baseline characteristics are presented for the per-protocol population.
752988|NCT00508404|"A total of 169 patients were screened, of whom 154 were enrolled into this study at 36 study centers in Austria, Belgium, France, Germany, and Sweden from 9 May 2007 through 18 June 2008.
~Results are reported through the primary analysis data cut-off date of 18 June 2009 (12 months after the last patient was enrolled)."|Participants received a FOLFIRI regimen in combination with panitumumab once every 14 days until diagnosed with radiographic disease progression, at which time the participant was withdrawn from the treatment phase. Participants were to complete a safety follow-up visit 8 weeks after the treatment phase.
752989|NCT00508391|Subjects were recruited from each investigator's general patient population at the medical clinic and selected according to the study inclusion/exclusion criteria.|All subjects enrolled in the study were previously implanted with a Lumax HF-T heart failure device. The study utilized an intention-to-treat analysis where subjects were analyzed according to the randomized treatment order, regardless of whether they received the treatment in the order stipulated by the protocol.
752990|NCT00508300||
752991|NCT00508274||
752992|NCT00508261||During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
752993|NCT00508196|Subjects previously implanted with a dual-chamber pacemaker for SND were recruited from the Ninewells Hospital and Medical School pacemaker clinic. No subject was pacemaker dependent and the indication for pacing was intermittent sinus arrest or sinus bradycardia.|Prior to randomization, as pre-study right ventricular pacing was variable among the subjects, pacing was programmed to produce minimal right ventricular pacing (using single-chamber atrial pacing or dual-chamber mode with long AV delay) for a minimal washout period of ≥1 week.
752994|NCT00508183|Enrollment occurred from June 2007 to June 2009 at The Ottawa Hospital in Ottawa,Ontario, and the PanAm Clinic in Winnipeg, Manitoba. The target population was men and women of any age with a diagnosis of a full-thickness tear of the rotator cuff according to clinical criteria.|Nine patients were never randomized because they either postponed or canceled the surgery, and nineteen patients were excluded prior to randomization for other reasons.
752995|NCT00508157||125 participants were enrolled in this study; 73 were considered baseline failures and were not randomized.
752996|NCT00508144|Recruitment Period: September 1, 2005 to June 30, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the 64 participants registered, fifty-eight (58) were eligible, four (4) were invaluable, and six (6) were not eligible to participate in this trial.
752997|NCT00508118||
752998|NCT00508105||
752999|NCT00508027|"During the study period (05/2006-09/2010), eligible adult and adolescent SCD subjects followed at the CHRCO Sickle Cell Center were approached about participation in this trial. Subjects were enrolled at steady-state (i.e., no acute illness or acute SCD-related complications) during a routine clinic visit."|There were no significant events following enrollment after inclusion and exclusion criteria were met.
753000|NCT00508001|78 patients were recruited at medical clinic|11 patients were screening failure due to inclusion criteria or exclusion criteria is not fulfilled
753001|NCT00507819|Of 125 eligible subjects contacted by the study team, 28 (22%) participated in the study.|
753002|NCT00507767|Recruitment period: July 24, 2007 to February 26, 2009. Al recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
753003|NCT00507689|Participants were enrolled at 7 sites in the United States. The first participant was screened on 12 September 2007. The last participant observation was on 03 May 2011.|51 participants were screened; 40 received emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)+HBIg in the pre-randomization period; 37 received FTC/TDF+HBIg or FTC/TDF in the randomized period.
753004|NCT00507559||
753005|NCT00507546|Subjects recruited from community|Subjects excluded if baseline measure detected the presence of melatonin metabolite in their urine.
753006|NCT00507507|Participants were enrolled at 34 sites in the North America, Europe, Asia, Australia, and New Zealand. The first participant was screened on 04 September 2007. The last participant observation for the Week 192 analysis was on 03 February 2012.|309 participants were screened and 129 were randomized; 126 randomized participants received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
753007|NCT00507455||
753008|NCT00507442||
753009|NCT00507429|Study truncated from 180 to 80 subjects. Subjects were enrolled from August 2007 through March 2010 at 40 worldwide, academic and local-regional clinical sites.|During screening, the diagnosis of anaplastic thyroid cancer was centrally confirmed often leading to enrollment and randomization delays.
753153|NCT00499460|Recruitment period was between November 2006 and August 2008. Healthy subjects were recruited from the University of Washington and Fred Hutchinson Cancer Research Center campuses through public notices.|
753010|NCT00507416|Participants took part in the study at 158 investigative sites in the United States from 26 June 2007 to 28 March 2013|Participants with previously untreated multiple myeloma were randomized in a 1:1:1 ratio to one of three treatment groups: VD: Velcade (bortezomib) and dexamethasone; VTD: Velcade, thalidomide, and dexamethasone; VMP: Velcade, melphalan, and prednisone.
753011|NCT00507208||
753012|NCT00507130|A total of 36 subjects were entered into the study between 28Jun2007 and 17Jul2008 at 8 sites in the United States of America (5 sites) and Canada (3 sites).|Treatment assignments were determined using a block randomization procedure at a 3:1 active treatment-to-placebo ratio through an interactive voice response system (IVRS). When a subject was assigned a Participant Identification Number by the IVRS, the subject was considered randomized into the study.
753013|NCT00506948|Recruitment Period: September 08, 2006 to October 27, 2009. All recruitment done in a medical clinic setting.|Of the 13 participants enrolled, three participants were ineligible and excluded from the study before treatment.
753014|NCT00506922|Recruitment Period: September 15, 2000 to July 26, 2007; All recruitment done at UT MD Anderson Cancer Center|A total of 150 patients were enrolled, and 147 were available for analysis. Two patients assigned to the 1.5 mg/m^2 arm were removed without receiving treatment (due to ineligibility, and poor donor cell collection). A patient assigned to arm 2.0 mg/m^2 withdrew consent before being treated.
753015|NCT00506909||The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
753016|NCT00506883|In 2007 between 4 April and 3 December 813 patients were screened at 74 US treatment centers. 72 centers randomized a total 575 patients. 185 patients at 54 centers had a qualifying gout flare and 184 are included in the ITT population. The remaining, 390 patients had no flare or had a flare that failed to qualify for study medication use|813 patients with confirmed diagnosis of gout based on American College of Rheumatology criteria were screened. 575 patients qualified and were randomized within 28 days of screening. 238 patients failed screening. The vast majority, 235 (98.7%) failed to meet inclusion/exclusion criteria.
753017|NCT00506857|Recruitment period: November 2003 to August 2011. All recruitment was done at UT MD Anderson Cancer Center.|Of the 82 participants enrolled, two (2) participants were excluded from the trial before starting treatment.
753018|NCT00506831||
753019|NCT00506779|Recruitment Period: December 29, 2003 to October 27, 2009. Recruitment was done at The University of Texas MD Anderson Cancer Center.|The study was terminated early due to poor enrollment .
753020|NCT00506753||6 participants withdrew or could not be located prior to treatment assignment.
753021|NCT00506714||
753022|NCT00506675|Between October 2007 and March 2009, 27 subjects were randomized to the intensive group and 28 randomized to the weaning group.|Eligible subjects were aged 3-<10 with strabismic and/or anisometropic amblyopia, best-corrected amblyopic eye acuity of 20/32 to 20/63, interocular acuity difference greater than or equal to 2 lines, and no improvement in amblyopic eye acuity between 2 consecutive visits at least 6 weeks apart.
753023|NCT00506662|A total of 57 centres in 2 countries: France (35) and United Kingdom (22)|Subjects in the trial were patients with type 2 diabetes being treated with oral anti-diabetic drug (OAD) therapy(ies) for at least 3 months prior to the trial and considered to benefit from insulin treatment. The randomisation target for this trial was 286.
753024|NCT00506597|The University of Texas (UT) MD Anderson Cancer Center Recruitment Period: May 07, 2007 to November 29, 2011. Recruitment site specifically at MD Anderson Cancer Center medical clinics.|This trial was part of a multi institutional effort by the drug company to make Erwinase available for use. The participants reported were recruited and treated as part of the trial site participation at MD Anderson Cancer Center.
753025|NCT00506493|A total of 90 subjects were consented into the study, of which 75 subjects received study treatment at 13 of the 15 investigational centers in the United States. The first subject was enrolled on September 18, 2007 and last patient enrolled on October 27, 2010.|No additional wash out, run-in, or transition was utilized during this study. A subject was considered enrolled once treatment occurred.
753026|NCT00506454||
753027|NCT00506441||
753028|NCT00506415||1,584 participants were enrolled, 1582 received study drug during the initial open label period; of these, 567 were qualified to enter a double blind randomized period.
753029|NCT00506389||
753030|NCT00506350||
753031|NCT00506285|Subjects (n=92) were recruited from 4-16-2007 through 10-24-2008. They were seen at the Psychiatry Research Clinic at the University of Utah School of Medicine.|There were 3 screening visits. Subjects met DSM-IV &/or Utah criteria for adult ADHD, experiencing at least moderate impairment. Most DSM-IV axis-I disorders were excluded. Of 92 subjects enrolled, 65 were randomized and produced double-blind data. The assessment procedure was more extensive than normal, leading to a high dropout rate.
753032|NCT00506155|Recruitment Period: June 1, 2007 to December 13, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer.|
753033|NCT00506142||
753034|NCT00506129|Recruitment Period: September 26, 2003 to November 05, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.|
753035|NCT00506077|First Patient Dosed: 11 February 2008; Last Patient Last Treatment: 08 October 2008. Six ex-U.S. study centers (3 Russia, 3 India).|At visit 1, patients were assessed using the protocol eligibility criteria. Eligible patients continued into an 8 day single-blind placebo washout/run-in period, and then were randomized at visit 3 to 1 of 2 cross-over treatment sequences.
753036|NCT00506064|Recruitment Period: 01/26/07 through 10/10/07. All participants recruited at UT MD Anderson Cancer Center.|Protocol terminated early as unable to accrue cases. There were four patients accrued of which three were not assigned, therefore data available for only one case.
753037|NCT00506025|Twenty-seven pregnant women who were enrolled were randomly selected for recruitment into this investigation.|
753038|NCT00505934|Subjects were recruited from sites in the United States, Belgium, Germany, France, Mexico, and Turkey. The study began in May 2008 and continued until March 2010, with the last subject's visit occurring in March of 2010.|Participant Flow refers to the Intent-to-treat (ITT) Population, consisting of all subjects who received at least 1 dose of study medication.
753039|NCT00505921|Recruitment period: 3/11/2003 to 10/27/2009. All participants were registered at UT MD Anderson Cancer Center|Eight patients of those twenty-seven registered failed to mobilize an adequate number of stem cells for an autologous transplant and were taken off the study.
753040|NCT00505895|Recruitment Period: January 18, 2002 to July 27, 2011. All recruitment done in a medical clinical setting.|Of the 52 participants enrolled, two were not included due to one patient experiencing pulmonary complication and another not completing the study follow up requirement.
753041|NCT00505778|Enrollment began 9 Aug 2007|
753042|NCT00505765||6 of 69 randomized participants were excluded prior to starting medication
753043|NCT00505752||
753044|NCT00505687|An Open-Label Extension Trial to Assess the Safety and Tolerability of Long-term Treatment of Rotigotine in Subjects with Idiopathic Parkinson's Disease in 26 locations from February 2005 to December 2008.|
753045|NCT00505661|Recruitment Period: 09/24/03 through 01/30/08. All participants recruited at UT MD Anderson Cancer Center.|Study terminated early due to slow patient accrual.
753046|NCT00505635|Recruitment Period: March 14, 2007 through July 9, 2009. All participants recruited at UT MD Anderson Cancer Center.|
753047|NCT00505622||
753048|NCT00505518|The study was conducted from September 2006 to November 2007 as a collaborative project between Massachusetts General Hospital and South Cove Manor Nursing Home, which is located in Boston's Chinatown.|
753049|NCT00505414|First participant in was enrolled on 29 June 2007 and the Last participant out was on the 02 February 2009. In general this was an out-patient study subject to country specific regulations.|Eligible participants were required to stop their previous analgesic [pain treatment] therapy at randomization. 136 participants consented. 43 participants were not eligible for randomization to tapentadol extended release or morphine controlled release at baseline. 93 participants started the titration period.
753050|NCT00505375||
753051|NCT00505362||
753052|NCT00505284||
753053|NCT00505076|Patients were recruited between June 2007 and July 2009.|46 subjects were excluded during screening.
753054|NCT00504985|Recruitment Period: 07/19/06 through 10/18/06. All participants recruited at UT MD Anderson Cancer Center.|Study terminated early due to low accrual.
753055|NCT00504894||
753056|NCT00504881|This multicenter study was conducted in 15 countries. It started in October 2007 and concluded in December 2008.|The Participant Flow refers to the Randomized Set (RS).
753057|NCT00504829|Subjects will be recruited from a combination of sources: advertising, clinical databases, clinical referrals, and the general subject population.|The washout period for subjects on lipid-lowering therapy will be 4 to 8 weeks, depending on their regimen.
753058|NCT00504777||
753059|NCT00504751||
753060|NCT00504725||
753061|NCT00504660|Recruitment period: September 23, 2003 to June 15, 2009. All patients recruited at UT MD Anderson Cancer Center.|Of the 75 enrolled participants, one was excluded prior to assignment to groups. The Anaplastic Tumors Arms (Arm 1 and Arm 2) were combined for recruitment demographics and data collection.
753062|NCT00504595||
753063|NCT00504556||
753064|NCT00504504|Recruitment Period: March 09, 2001 to August 29, 2007. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 85 participants enrolled, three participants were excluded prior to assignment to groups as ineligible.
753065|NCT00504426||
753066|NCT00504348||
753067|NCT00504309||
753068|NCT00504257|Between March 2007 and February 2011, 45 patients were screened.|
753069|NCT00504231||
753070|NCT00504166|Recruitment period: Feb 2006-March 2007. Recruitment ads were posted at different UCSF campuses, senior centers, churches, train stations. We also utilized mass mailing lists, newspaper ad and radio broadcasts|
753071|NCT00504153||
753072|NCT00504075|First enrollment: 04 September 2007. Last Subject completed: 05 August 2011. Thirty-five sites in the United States, India and Argentina, all hospital clinics.|This was an open label study. All enrolled subjects received study medication.
753073|NCT00504023||
753074|NCT00503997|The trial was open to accrual from 12/13/2006 to 4/9/2008.|This study consented 42 patients. One patient was found ineligible.
753075|NCT00503984||
753076|NCT00503906||
753077|NCT00503880||
753078|NCT00503867|Three medical centers in the US enrolled 10 patients from July 18, 2007 to March 9, 2010.|
753079|NCT00503841|"44 participants signed consent starting 1-9-08 and recruitment ending with the last participant signing on 1-19-10. All participants enrolled onto screening portion of study, but none were ever put onto the treatment portion of the study."|All participants that signed consent were screen failures.
753080|NCT00503776|This study was open to accrual from 01/01/2006 through 03/05/2008.|43 patients consented, one was ineligible for a total of 42 patients on study.
753081|NCT00503750||
753082|NCT00503698|A total of 202 sites in 17 countries: United States, Canada, United Kingdom, Sweden, Denmark, France, Germany, Poland, Hungary, Spain, Portugal, Turkey, Israel, Argentina, Brazil, Russia, South Africa. Italy planned to participate but never randomised any subjects.|Subjects who were malnourished (based on serum albumin value below 40 g/L, assessed centrally) and had received adequate haemodialysis treatment for more than three months at time of trial entry, were eligible.
753083|NCT00503685||Participants with progressive disease (PD) or death are considered having completed study.
753084|NCT00503581||
753085|NCT00503425||
753086|NCT00503399||Of the 174 participants who were enrolled into the study, 92 were eligible and randomly assigned to the treatment arms.
753087|NCT00503308|A randomized-controlled, non-inferiority trial was conducted from October 2006 through February 2008 at San Francisco General Hospital (SFGH), the public teaching hospital of the City and County of San Francisco.|A total of 278 English- and Spanish-speaking pregnant women were randomized to receive either abbreviated or standard nurse-performed HIV test counseling at the initial prenatal visit.
753088|NCT00503139||
753089|NCT00503113||Total 801 participants randomized. Of the randomized patients, 263 who received at least one dose of ibandronate as an injection, 263 who received at least one dose of ibandronate as an infusion and 267 patients who received at least one dose of alendronate had at least one post-baseline assessment and were included in the safety analysis.
753154|NCT00499447|Participants were recruited from the Radiation Oncology Clinic at the Comprehensive Cancer Center of Wake Forest University.|
753090|NCT00503009||Eligible subjects were randomized to one of two sputum induction groups (sputum induction, no sputum induction) and then stratified at a second randomization to one of three treatment groups (Fluticasone Propionate/Salmeterol [FSC 250/50] mcg twice a day [BID], Fluticasone Propionate [FP] 250 mcg BID, or Placebo BID).
753091|NCT00502996|A total of 246 participants were enrolled in study conducted from 20 February 2006 to 05 December 2008 across 56 study centers in 10 Latin American countries.|Out of 246 participants, fourteen did not receive study drug and were not included in analysis population.
753092|NCT00502944|Recruitment took place from February 7, 2007 to July 9, 2008 at Brigham and Women's Hospital emergency department. Oral HIV testing was offered to eligible patients by either HIV counselors or emergency service assistants (existing members of emergency department personnel).|
753093|NCT00502905|Recruitment Period: April 12, 2001 through July 14, 2005. All participants recruited at UT MD Anderson Cancer Center.|Of the 200 participants enrolled, four participants were excluded from the trial and did not receive treatment.
753094|NCT00502853||
753095|NCT00502840||
753096|NCT00502801||Two enrolled subjects didn't take study medication and weren't qualified for safety population.
753097|NCT00502775||
753098|NCT00502697|The sample consisted of pregnant women receiving prenatal care with a (physician or nurse-midwife) at a large regional medical center in the Southeastern U.S. from April, 2007 through January, 2010.|
753099|NCT00502671||
753100|NCT00502593|138 subjects were enrolled as part of the first 107066/Phase A part of this NCT00502593 study. This first part was then followed by a second and third part (Phases B [study 108498] and C [study 108500] during which 134 and 133 subjects were enrolled, respectively. Duration of the study was of 24 months for all subjects.|For safety reasons, subjects in each group were enrolled in a staggered manner, with enrolment taking place sequentially into 2 age strata, '6-9 years' 1st, and '3-5 years' next.
753101|NCT00502320|Recruitment began in August 2006 and was completed by October 2007. Participants, who at the time were receiving outpatient psychiatric services through Lehigh Valley Hospital, were recruited via referral through the department of psychiatry, and also through print advertisement. Participants received no compensation for participating in the study.|50 individuals signed the informed consent document, one was a screen failure, so 49 participants started study medication. During the study, both treatment groups were maintained on their usual medications for depression and allowed treatment as usual, including medication adjustments.
753102|NCT00502307|Participants who met all the inclusion and none of the exclusion criteria were enrolled|"All participants underwent inclusion and exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures.
~All the study assessments were performed as per the schedule of assessment."
753103|NCT00502242|A Randomized, Placebo Controlled, Double-Blind Comparative Study Evaluating the Effect of Ramipril on Urinary Protein Excretion in Maintenance Renal Transplant Patients Converted to Sirolimus.|Eligible participants were randomly assigned in a Double-Blind fashion to the Ramipril treatment group or the Placebo control group.
753104|NCT00502216||
753105|NCT00502203|Recruitment period: August 29, 2001 to May 08, 2009. All recruitment was done at medical clinics.|
753106|NCT00501995||
753107|NCT00501969|An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Advanced-Stage Idiopathic Parkinson's Disease who are not well controlled on L-Dopa from August 2004 to December 2008|
753108|NCT00501943|Patients with diagnosis of early Relapsing Remitting MS were invited to participate in the study at 2 US sites- UCSF and OHSU during the period between Dec 2007 and May 2010|
753109|NCT00501891||
753110|NCT00501852||
753111|NCT00501644|Recruitment period 01/07/03 to 07/25/07. All patients were recruited at UT MD Anderson Cancer Center.|
753112|NCT00501631||
753113|NCT00501592|Sixty four subjects were enrolled in the study at 4 sites. Of the randomized subjects, 20 were randomized to INT-747 25 mg, 21 subjects to INT-747 50 mg, and 23 subjects to placebo. Study enrollment by center ranged from 4 to 31 subjects.|A protocol amendment allowed for the enrollment of 14 replacement subjects (to enroll up to 56 subjects meeting eligibility requirements). The amendment pre-specified that the original 14 subjects being replaced would not be included in the efficacy analysis since they did not meet the protocol requirements.
753114|NCT00501540|This study enrolled participants with low grade neuroendocrine tumors (NETs) from July 2007 through May 2009.|
753115|NCT00501345|Recruitment Period: 02/28/02 through 04/22/04. All participants recruited at UT MD Anderson Cancer Center.|Study terminated as a result of difficulty in accrual of candidate patients for enrollment. Six patients were enrolled but one patient did not meet eligibility criteria.
753116|NCT00501293|Open-label, extension study of Methylphenidate Transdermal System (MTS) in subjects who had previously received study medication (MTS or placebo) in the antecedent study, SPD485-409 (NCT00499863). Upon entry into this study (SPD485-410), all subjects received MTS treatment regardless of the study treatment they had received in study SPD485-409.|The study consisted of a dose optimization period (approx. 5 weeks) and a maintenance period (5 months). Methylphenidate Transdermal System (MTS)(10, 15, 20 or 30 mg / 9 hour dose patch) was applied once-daily on the alternating hip for a 9-hour wear time. One subject in the MTS group was enrolled in error and was removed prior to receiving drug.
753117|NCT00501228|Recruitment Period: 06/15/2005 through 05/03/2006. All participants enrolled at U.T. M.D. Anderson Cancer Center.|Study terminated early due to lack of accrual.
753118|NCT00501085||521 Subjects were enrolled (defined as signing the informed consent). 515 Subjects started treatment and underwent LAP-BAND implantation. 6 Subjects did not have the LAP-BAND implanted after enrolling and signing the informed consent.
753119|NCT00501059|Overall, 15823 subjects were screened. Of these, 3277 subjects were screening failures. The remaining 12546 subjects were randomized to treatment.|
753120|NCT00501046||
753155|NCT00499408||
753156|NCT00499369||
753157|NCT00499343|Recruitment period: 02/12/2004 through 07/13/2007. All participants recruited at U.T. M.D. Anderson Cancer Center and participating institutions.|
753158|NCT00499252|The study was activated on 6/4/2007 and closed to accrual on 1/29/2009.|
753159|NCT00499122||
753121|NCT00501007|A total of 203 smokers were recruited from New Jersey state funded tobacco dependence treatment clinics, called QuitCenters, through clinician referrals or responses to recruitment flyers.|Reasons for exclusion included the following: Failed diagnostic screen, passed quit date/already using smoking cessation medications, changed mind about participating, smoked fewer than 10 cigarettes per day, did not have a goal to quit smoking, transportation issues, lost contact before baseline appointment, and low mini Mental Status Exam score.
753122|NCT00500903|Participants took part in the study at 3 investigative sites in the United States from 15 May 2007 to 23 February 2011.|Participants with a diagnosis of advanced malignancies were enrolled in 1 of 3 treatment groups, alisertib 5 to 150 mg Powder-in-Capsule (PIC) dose escalation cohort, alisertib 10 or 20 mg Enteric-coated Tablet (ECT) dose escalation cohort, or alisertib 40 mg PIC/ECT in a crossover design followed by alisertib 50 mg relative bioavailability cohort.
753123|NCT00500890|This study received IRB approval August 3, 2005 and was opened to recruitment September 2, 2005. The study remained open to recruitment until December 9, 2009. The study was terminated by the local IRB on December 14, 2017.|
753124|NCT00500760|153 patients were enrolled with 89 patients on panitumumab plus chemoradiation arm, and 64 patients on chemoradiotherapy alone arm.|
753125|NCT00500682||
753126|NCT00500656||85 patients participated in the study(36 in the icatibant group and 38 in the tranexamic acid group)3 patients with laryngeal symptoms at Baseline.8 Patients were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing
753127|NCT00500578|Fifty patients were enrolled between October 2003 and March 2008, either from the outpatient settings or inpatients. Eligible patients were randomized to either Arm 1 (Standard regimen: 6gm over 18 hours every 24 hours) or Arm 2 (Modified regimen: 6gm over 3 hours every 8 hours).|Only one patient was excluded from the trial after enrollment and before starting the intervention because his Chest X-Ray was read later on as positive for infiltrates.
753128|NCT00500539||
753129|NCT00500448||
753130|NCT00500370|Subject recruitment occurred between July 2007 and August 2007 at medical clinics in the United States.|Prior to randomization, subjects participated in a 1-week, single-blind placebo lead-in period.
753131|NCT00500357|915 participants were enrolled in core study NCT00269672 (6115A1-500); 914 participants received 13-valent pneumococcal conjugate vaccine plus or minus aluminum phosphate (13vPnC+AlPO4 or 13vPnC-AlPO4) or 23-valent pneumococcal polysaccharide vaccine (23vPS) in Year 0 (Vaccination 1 [Vax 1]) followed by 13vPnC+AlPO4 or 23vPS in Year 1 (Vax 2).|105 participants from the core study NCT00269672 (6115A1-500) who had received 13vPnC+AlPO4 (13vPnC) followed by 23vPS enrolled in the follow-up study NCT00500357 (6115A1-3009) 1 year after completion of the core study and received a subsequent 13vPnC dose at Year 2 (Vax 3).
753132|NCT00500331|This study was conducted at 121 centers of which 95 randomized participants, in 18 countries (9 European, 8 International, and the United States) from 23 January 2007 to 14 February 2008.|The Screening period was of 2 weeks. A glucose meter and detailed instructions for use were provided to all participants at the Screening visit for self- monitoring of fasting blood glucose levels and a Daily Glucose Monitoring Log for recording blood glucose information. Dietary and exercise advice was provided at randomization.
753133|NCT00500318|Patient recruitment occurred from July to October of 2007 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)|All demographic and baseline characteristics were analyzed descriptively just for the Safety population.
753134|NCT00500292|First patient randomised 19 March 2007, last patient randomised 11 Nov 2007, data cut off date 8 March 2008. 109 patients were enrolled in the study.|109 patients were enrolled/screened to the study but only 104 patients were entered treatment/randomized.
753135|NCT00500240|Recruitment Period: 04/27/2004 through 7/1/2008. All participants recruited at the University of Texas (UT) MD Anderson Cancer Center.|Fifty-two participants were randomized to a conventional treatment arm or an intensive insulin intervention arm. One participant on the conventional control arm was excluded and did not receive allocated intervention.
753136|NCT00500149|129 subjects were enrolled for dose optimization phase, 12 discontinued, and 117 were randomized to the cross-over phase.|The study consisted of an open-label dose-optimization phase (4 weeks), followed by a randomized, placebo-controlled, 2-way crossover phase (1 week each).
753137|NCT00500110|Recruitment at Medical Clinic from 6/13/03 to 11/29/04.|
753138|NCT00500071||The study had three phases; 1)screening and wash-out; 2) dose-optimization (5 weeks) and maintenance (2 weeks); 3) 30-day safety follow-up. Dosing ranged from 20-70 mg once daily of Vyvanse.
753139|NCT00500045||
753140|NCT00499915||
753141|NCT00499889|Recruitment Period: 02/12/03 to 01/15/09. All patients were recruited at UT MD Anderson Cancer Center.|One patient registered for transplant became ineligible before any treatment due to infection and was taken off study; 41 patients received the transplant regimen and an Allogeneic transplant.
753142|NCT00499863||217 subjects were enrolled and randomized. The study included a screening/washout period, a 5 week dose optimization period, a 2 week maintenance period, and a follow-up period.
753143|NCT00500266||
753144|NCT00499746||
753145|NCT00499694||
753146|NCT00499681|This study was open from 07/12/2007 through 12/09/2010.|This is a two-part study. Part I consists of two arms: investigational drug plus Letrozole or placebo and Letrozole. Part II is Letrozole plus Lapatinib. Six patients signed consent. Two patients had toxicity or relapse, thus withdrew from the study.
753147|NCT00499655||
753148|NCT00499616||
753149|NCT00499603|Participants with triple negative breast cancer who were seen in the Breast Medical Oncology clinic of the MD Anderson Cancer Center were enrolled in the study prior to surgery from August 16, 2007 to September 14, 2010.|Sixty-two (62) participants were registered but only fifty (50) were randomized. Nine patients failed the screening process, two patients withdrew consent, and one patient was discontinued due to therapy interruption for greater than 21 days.
753150|NCT00499590||
753151|NCT00499486||During baseline evaluation (approximately 72 hours prior to treatment with rapamycin), patients will receive a single dose of 3 mg oral midazolam as phenotypic evaluation of CYP3A4 activity.
753152|NCT00499473||
754427|NCT00429104|Recruitment Period of November 2002 to April 2007, all recruited at University of Texas MD Anderson Cancer Center.|
753160|NCT00499109|Participants were registered onto the trial between May 8, 2007 and December 23, 2010. Study sites included Moffitt Cancer Center and 8 other institutions with locations in the United States, Puerto Rico and Germany.|
753161|NCT00499096||
753162|NCT00499083||
753163|NCT00499031||
753164|NCT00498940|Enrollment began on April 1, 2007 and ended March 1, 2012. The trial was conducted at Columbia University and University of California, Lost Angeles.|Enrolled patients not meeting study criteria just prior to the start of study, withdrawn at surgeon's discretion, or change in surgery type were not randomized. 61 out of the 111 enrolled subjects were randomized, received study intervention and had data analyzed.
753165|NCT00498927||
753166|NCT00498797|First patient randomised 24 January 2006, last patient randomised 24 Nov 2006, data cut off data 21 July 2007|
753167|NCT00498706|Participants were recruited from November 2007 to December 2010 from general internal medicine clinics in Northwestern Medical Faculty Foundation and Northwestern Memorial Physician's Group, and from 4 primary care clinic members of Northwestern's Practice-Based Research Network.|
753168|NCT00498628|Interested candidates responded by telephone to advertisements at 5 academic centers in the United States between December 2007 and May 2009.|218 comprises the Modified Intent To Treat group (MITT)
753169|NCT00498615||
753170|NCT00498602|Planned duration was approximately 110 weeks (including 6 week screening period, 52 weeks of dosing, and 52 weeks of follow-up). Participants who completed the NCT00498602 study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol extension protocol NCT00960531.|The Basic Results disclose pooled data from studies NCT00479557 and NCT00498602.
753171|NCT00498550||
753172|NCT00498485||
753173|NCT00498433||Total 46 patients entered into the study; 10 patients in part 1 received study drug. 36 patients enrolled into part 2 and and 16 patients received study drug.
753174|NCT00498368||
753175|NCT00498355|Patients were recruited from the F.I. Proctor Foundation Uveitis Clinica at University of California San Francisco.|
753176|NCT00498186|A total of 295 subjects belong to the Enrolled Set (ES) and all of them received at least one dose of trial medication, so they all belong to the Safety Set (SS).|Participant Flow information and Baseline Characteristics belong to the Safety Set (SS).
753177|NCT00498173||
753178|NCT00497874|A total of 902 primary care patients were recruited from the 17 clinics of a large multi-specialty medical group practice in Eastern Massachusetts (N=791) and a large health center in Chicago (N=111).|
753179|NCT00497796||
753180|NCT00497770|Target goals for recruitment were not met due to slow enrollment.|
753181|NCT00497198||
753182|NCT00497146|Participants were enrolled in the study at US and ex-US investigative sites. Recruitment began in March 2008 and ended in December 2009. The study population consisted of participants with Stage 3/4 chronic kidney disease who had a diagnosis of left ventricular hypertrophy confirmed by echocardiogram and cardiac magnetic resonance imaging.|
753183|NCT00497081||
753184|NCT00497055||
753185|NCT00496964||
753186|NCT00496873|Recruitment Period: June 29, 2005 to July 26, 2007. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 100 participants recruited, fifteen were excluded as screen failures prior to study assignment leaving an enrollment of 85 for the study.
753187|NCT00496860|Between 08-2007 and 05-2009, 118 patients were consented and screened, 56 were Human leukocyte antigen (HLA)-A2 positive and had tumor specimens that were positive for target p53 (aa 264-272)/HLA-A*0201 complex. Thirty HLA-A2-positive patients with p53/HLA-A*0201 tumors either withdrew consent or did not meet other inclusion/exclusion criteria.|
753188|NCT00496834|"7 centers participated in this study (7 medical centers of university).
~FPE (First patient enrolled): Feb-2008, FPI (First patient in): Feb-2008, LPO (Last patient out): Sep-2009"|
753189|NCT00496808|Recruitment Period: March 2005 - November 2010. All recruitment was at UT MD Anderson Cancer Center.|
753190|NCT00496782||
753191|NCT00496769||A total 6421 patients were enrolled in the study. Of these, 5598 were randomized (2807 to apixaban and 2791 to acetylsalicylic acid). Most (435) of the patients who were not randomized (823) no longer met study criteria. Of those randomized, 5578 received treatment (2798 with apixaban, and 2780 with acetylsalicylic acid).
753192|NCT00496756||
753193|NCT00496730|Patients were recruited between June 2007 and May 2008.|Patients who have Metabolic syndrome and Hypercholesterolemia had 4 weeks wash-out period were enrolled in this study. The eligible patients was allocated to one of Vytorin 10/20 mg or Atorvastatin 10 mg group.
753194|NCT00496626||
753195|NCT00496587|Recruitment Period: July 2, 2007 to February 24, 2012. All recruitment done at The University of Texas Cancer Center.|
753196|NCT00496483||
753197|NCT00496470||
753198|NCT00496379|Patients were enrolled at Dana-Farber/Harvard Cancer Center between 8/1/2007-10/29/2009.|
753199|NCT00496366|We are reporting results on 11 subjects enrolled, who were recruited from July 2007 through December 2009. Subjects were recruited through the Cancer Institute of New Jersey's Oncology Group and this study was closed pre-maturely due to slow accrual.|
753200|NCT00496340|Participants were enrolled at H. Lee Moffitt Cancer Center between February 2008 and March 2011.|
753201|NCT00496262|Subjects were enrolled at study sites in the USA and Italy.|
753202|NCT00496197||
753203|NCT00496080|Recruitment took place from June 2007 through May 2009. Sites included hospitals, surgical centers and private practices in North America.|
753204|NCT00496054|"Phase III
~First Patient In (FPI): 09-May-2008
~Last Patient Out (LPO): 20-Nov-2008
~Multi-center study
~Department of Paediatrics, Kashyap Nursing Home, Mumbai.
~Department of Paediatrics, KEM Hospital, Pune
~Department of Paediatrics, J.K.Lon, SMS Hospital, Jaipur
~Panchsheel Hospital, Delhi"|Open-label, single-arm study. Healthy infants between the ages of 6 weeks through exactly 12 weeks (≥42 to ≤84 days) at entry who did not have clinical evidence of active gastrointestinal illness; who did not have fever, with a rectal temperature of greater than and equal to 38 degrees Celsius at first vaccination were enrolled in the study.
754424|NCT00429182|Recruitment Period: February 27, 2007 to July 25, 2011. All Recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
753205|NCT00496015|This was a multicenter study with the same centers as the primary vaccination study 10PN-PD-DIT-010 (107017/NCT00370318) and all subjects enrolled in the primary vaccination study and having received Synflorix vaccine were invited to participate in the study. In addition, an age-matched pneumococcal vaccine unprimed control group has been enrolled.|
753206|NCT00495820|60 subjects meeting the inclusion and exclusion criteria were recruited from outpatient clinics at the Nebraska Western Iowa Health Care System between 2006-2009.|
753207|NCT00495794||
753208|NCT00495755||
753209|NCT00495716||
753210|NCT00495677||
753211|NCT00495625|All patients with unresectable or metastatic hepatocellular cancer (HCC) seen at the Moffitt Cancer Center Gastrointestinal (GI) Clinic were screened for eligibility to be enrolled in the study.|
753212|NCT00495612||
753213|NCT00495586|353 patients invited to participate in this trial, 32 did not fulfill the inclusion criteria (14 presented a forced expiratory volume in one second [FEV1]/forced vital capacity [FVC] ratio > 70% and 18 a FEV1<50%). Three more had a positive X-ray for pneumonia and were therefore excluded.|
753214|NCT00495521|The study was open to eligible patients under the care of or referred to investigators at 5 different academic medical centers from July 2007 through October 2008.|Recruitment was slow with only 2 patients entered.
753215|NCT00495495||
753216|NCT00495469|The study was conducted at 130 centers in 14 countries (9 European, 3 International countries, Canada, and the United States) during the period from 17 August 2007 to 5 June 2008.|A total of 822 participants with Type 2 Diabetes Mellitus who were treatment naïve, entered the 2-week screening period. Of these, 570 were screen failures. The primary reason for screening failure was the participant not meeting eligibility criteria. Out of 252 randomized participants, 250 participants received study drug.
753217|NCT00495391|This study recruited patients from 10 study sites in the United States, including a Veterans Administrations hospital.|
753218|NCT00495222||
753219|NCT00495170|Inoperable stage III NSCLC with KPS of 70-100, medically fit to receive concurrent and/or induction chemotherapy, weight loss ≤ 10% in the 6 months before diagnosis, provide informed consent. Patients were not enrolled in cases of prior chest radiation therapy and/or pregnancy, with prior and/or concomitant malignant neoplasms.|
753220|NCT00495157||
753221|NCT00495131|Recruitment period: 2006 June to September Location: academic centers|No wash out period in the study; all were treatment-naive All the patients who were eligible in the study were assigned to either groups without exclusion.
753222|NCT00495079|Subjects were enrolled and treated at 22 sites in United States, Canada, Germany, Israel and United Kingdom. The first subject was infused on August 2, 2007. The last subject completed study on August 8, 2010.|2.25 mg/m^2 Marqibo administered intravenously via peripheral or central venous access over 60 minutes (+-10 minutes)
753223|NCT00495040|(1)Inoperable NSCLC;(2)T1N0M0 (stage IA) that was centrally or superiorly located ≤ 2 cm in all directions of any critical mediastinal structure; T2N0M0 in any location (stage IB, tumor size>3 cm, with no upper size limit), or selected T3N0M0 (stage II,chest wall, mediastinal pleura, or parietal pericardium involvement) in any location (3)ECOG≤2|
753224|NCT00494975||
753225|NCT00494871|The first participant entered the study on 08 Jun 2007, and the last participant completed the study on 19 Jan 2010. The study was conducted at 167 centers in Japan. 164 study centers enrolled at least 1 participant.|In total, 1439 participants were screened for study eligibility; 159 participants were screening failures and were not randomized. Therefore, 1280 participants (640 in each group) were randomized.
753226|NCT00494806|Recruitment Period: 11/18/05 through 03/05/07. All participants recruited at UT MD Anderson Cancer Center, prior to surgery during their preoperative evaluation in the Anesthesia Assessment and Preoperative centers.|There were no enrolled participates excluded from the trial prior to assignment to groups. All patients approached accepted participation into the study.
753227|NCT00494780||
753228|NCT00494676|Participants were recruited at 13 study sites, including Dr. Peli's lab at Schepens, 11 vision rehabilitation clinics in the US, and one in the UK. The clinics included university, hospital and private-practice clinics. Each site recruited a median of 7 participants (range 3 to 12). Data were collected in the period October 2007 to January 2010.|97 subjects were screened for eligibility of which 73 met the study criteria and were enrolled. The main reasons for not meeting the inclusion criteria were incomplete hemianopia and spatial neglect.
753229|NCT00494585|Recruitment Period: 6/28/2007 through 10/25/2007. All participants recruited at UT MD Anderson Cancer Center.|Of the 27 participants registered, 5 participants were ineligible to participate.
753230|NCT00494507||The original trial design included an Acetazolamide (ACZ) drug arm which was subsequently removed. Five participants randomized to ACZ and one ineligible participant are not included in the trial results reported here.
753231|NCT00494494||
753232|NCT00494481|First patient randomised 03 February 2006, last patient randomised 25 April 2007, data cut off data 23 June 2007|
753233|NCT00494442|The first patient was enrolled on June 11, 2007 and efficacy and safety data were collected up to the data cut-off of March 17, 2009. Patients were enrolled at 12 centres in 5 countries: Australia, Germany, Spain, Sweden and the USA.|Two cohorts of women with Breast Cancer gene 1 (BRCA1)- or BRCA2-associated ovarian cancer who had failed at least one prior chemotherapy in the advanced/metastatic setting, were planned to receive olaparib 100 mg bd (n= up to 24) or 400 mg bd (n= up to 40). Enrolment to 2 cohorts was sequential with the 400 mg bd cohort being recruited first.
753234|NCT00494299|The first subject was enrolled on 27 Aug 2006. The final data collection date for the primary endpoint analysis was 10 Jul 2009. The study was conducted at 77 centers from 2 countries: Korea (7 centers) and Japan (70). 76 centers enrolled at least 1 subject (7 centers in Korea and 69 in Japan). The last subject's last visit occurred on 19 Nov 2010.|Of 552 subjects screened, 458 were randomized and were valid for the efficacy analyses (intent to treat [ITT] population), and 456 received at least 1 dose of study drug and were valid for the safety analyses. 229 subjects were randomized to each group (sorafenib or placebo).
753270|NCT00492336|Subjects were recruited between May 2007-October 2011 from mental health clinics throughout the community.|Participants were excluded before assignment to treatment groups if they met any of the exclusion criteria, if they became clinically unstable, or they decided that the demands of the study were too great. 84 participants were enrolled into active participation; 57 started study treatment.
753235|NCT00494234|The first patient was enrolled on June 15, 2007 and efficacy and safety data were collected up to the data cut-off of February 27, 2009. Patients were enrolled at 16 centres in 6 countries: Australia, Germany, Spain, Sweden, UK and the USA.|Two cohorts of up to 27 women with BRCA1- or BRCA2-associated breast cancer who had failed at least one prior chemotherapy and/or endocrine therapy in the advanced/metastatic setting, were assigned to receive olaparib 100 mg bd or 400 mg bd. Enrolment into the 2 cohorts was sequential with the 400 mg bd cohort being recruited first.
753236|NCT00494221|Randomised=ITT=Safety: Cediranib 20mg=58, Cediranib 30mg=56, Placebo=58|PFS & OS: median based on Kaplan Meier analysis (i.e. adjusted for censored observations) but full range based on raw data (i.e. not adjusted for censored observations). OS: median non-estimable due to censored observations
753237|NCT00494143|subjects were recruited through bulletin board ads and through a local VA amputee clinic. Subjects were included if between the ages of 18 and 80 years, had used a prosthesis for grtr than 2 years, wore the prosthesis grtr than 8 hours per day, did not ambulate with u/e aids and had no falls in the prior 6 mo or known neuro or msk deficits.|Subjects were provided with suitable acclimatization prior to testing with their initial randomized prosthetic foot type.
753238|NCT00494091||
753239|NCT00494026||
753240|NCT00494013||"789 patients were screened; 347 patients failed screening or discontinued before randomization. Demographics and outcomes are reported on the Full Analysis Set: all randomized patients who received at least one dose of study drug and had at least one post-baseline measurement for the dependent variable, according to Intent to Treat principles."
753241|NCT00493974|Participants were recruited from ER's and inpatient units from 10 main clinical sites (and their affiliated hospitals) between September 2007 and October 2008.|Participants were screened using the eligibility criteria before randomization.
753242|NCT00493805||
753243|NCT00493779||103 subjects who were enrolled and treated with clopidogrel, were enrolled, of which 98 subjects had discontinued clopidogrel treatment and entered follow-up phase (study phase).
753244|NCT00493649||
753245|NCT00493636|The period of study was 28 Jun 2007 (first subject randomized) to 29 Feb 2012 (overall survival data cutoff date). There were 40 centers in the United States that participated in this trial.|181 patients were assessed for eligiblity. Of these, 21 patients were excluded from the trial due to not meeting the eligibility criteria, leaving 160 patients who were randomized.
753246|NCT00493467|Recruitment Period: June 12, 2006 to May 08, 2009. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.|
753247|NCT00493454|Recruitment Period: April 13, 2006 to November 8, 2007. All participants recruited in medical clinic at UT MD Anderson Cancer Center.|
753248|NCT00493311|Subjects were recruited at a single clinical research facility in the United States during July to September 2007.|Eligible subjects received intravenous endotoxin to induce fever and were then randomized to receive either 1 g acetaminophen in 100 ml intravenous solution or 100 ml placebo solution.
753249|NCT00493285|Participants 6 to < 24 months of age were screened prior to randomization at 13 sites in the USA. The first subject entered the study on 02Jul2007 and the last subject completed the study on 20Apr2010.|A total of 49 participants were entered into the study between 02Jul2007 and 25Jun2009. Participants were RSV and PIV3 seronegative at screening, and randomized in a 2:1 ratio to receive MEDI-534 or placebo, and randomization was stratified by age (≤ 12 months vs > 12 months).
753250|NCT00493246|The study was conducted at 5 sites in the US from 27 June 2007 to 01Sep 2008.|
753251|NCT00493220|Healthy volunteers recruited via subject-initiated telephone or internet contacts or visits to Phase I unit. Those considered potentially eligible were, after obtaining consent, screened in detail to determine eligibility against protocol eligibility criteria.|
753252|NCT00493181|Recruitment Period 10/15/05 to 9/17/07. All participants registered at The University of Texas M.D. Anderson Cancer Center.|
753253|NCT00493064||
753254|NCT00493038|Enrollment started on 13 Feb 2006 and the last study visit occurred on 20 Jan 2008. The study was conducted at 34 active otorhinolaryngology centers in Italy.|Number of patients screened: 293 Number of patients having at least one observation under study medication: 287 (intention-to-treat population = ITT population) Number of patients adhered to major predefined aspects of the study protocol: 251 (per-protocol population = PP population). Primary population for efficacy was PP.
753255|NCT00493025||
753256|NCT00493012||
753257|NCT00492973|Between 5/1/2006 and 5/1/2008, a total of 101 patients were recruited to participate in the study during a regularly-scheduled office visit at an orthopedic clinic.|Of the 101 patients that were consented, 11 patients opted to cancel surgery, 11 patients asked to be removed from the study prior to surgery, and 3 patients were excluded as they were found to have existing allergies to study medications. The remaining sample of 76 patients were randomly assigned to one of the two study groups.
753258|NCT00492921||
753259|NCT00492856||
753260|NCT00492752|Subjects with advanced hepatocellular carcinoma were enrolled from 12 Oct 2005 to 26 Jan 2007 at 23 centers in China (15 centers), Taiwan (5 centers), and Korea (3 centers).|271 subjects were enrolled in a 28-day screening period; 226 subjects were randomized either to Sorafenib or placebo (2:1 ratio) (intent-to-treat [ITT] population: for efficacy analysis); 224 subjects received at least one dose of study drug (safety population: for safety analysis). Majority of screen failures did not meet the inclusion criteria.
753261|NCT00492726|Subjects were enrolled from 02 July 2006 to 31 December 2008 at 52 centers in 14 countries: Argentina (9), Belgium (3), Bulgaria (4), Estonia (3), France (2 ), Germany (5), Greece (1), Israel (2), Latvia (6), Lithuania (4), Romania (5), Russia (3), South Africa (3), and Spain (2).|830 subjects screened, 804 randomized. 6 not treated. Safety/Intent to treat population = 798 subjects with at least 1 dose taken and 1 observation after intake (Moxifloxacin 408; Ertapenem 390). Per protocol population = 699 subjects with no major protocol deviations that would have influenced the primary outcome (Moxifloxacin 352; Ertapenem 347).
753262|NCT00492648||
753263|NCT00492622||
753264|NCT00492583||
753265|NCT00492557||A total of 1185 participants were enrolled, of which 1160 were randomized.
753266|NCT00492544||
753267|NCT00492531|Subjects with Sickle cell hemoglobinopathy were recruited from 10 centers(9 in United States and 1 in United Kingdom)|
753268|NCT00492401||
753269|NCT00492349||
753271|NCT00492297|This study had a 2-stage Simon optimal design consisting of 30 subjects in the first stage and 52 subjects in the second stage for a planned total of 82 subjects. Actually a total of 96 subjects were enrolled and 83 were treated; 32 in the 1st stage and 51 in the second stage. The study was conducted at 8 centers in the UK and 4 centers in France.|Of the 96 enrolled subjects, 13 were screening failures. The reasons for screening failure were violation of inclusion/exclusion criteria (12) and death due to Progressive Disease (PD) (1). The remaining 83 subjects all received at least one dose of sorafenib and dacarbazine.
753272|NCT00492284||
753273|NCT00492232|Subjects were enrolled at 38 investigative sites in the United States from 26 April 2007 to 28 May 2008.|Subjects completed a 4-week single-blind placebo run-in period prior to randomization in the double-blind treatment period (DBTP). During this time they took placebo-matching tablets once-daily (QD) with concomitant current zolpidem therapy. Subjects used a daily subject diary to record zolpidem dose reduction, daily activities, and sleep quality.
753274|NCT00492206|Subjects recruited from the surgically unresectable stage IIIA or IIIB NSCLC patient populations|Non-Small Cell Lung Cancer, unresectable limited to Stage IIIA/B.
753275|NCT00492115|Patients were referred to UCSD by community neurologists or volunteered after hearing a talk about the study at PD support group meetings.|"183 contacted; 144 screened/phone; 106 consented, 5 dropped/12 excluded; 89 screened for apnea with sleep study (2 dropped during night study), 44 had no sleep apnea. 5 declined treatment.
~19 participants randomized to each arm"
753276|NCT00492089|Recruitment Period: June 20, 2007 to December 07, 2009. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 15 patients enrolled, four participants were excluded from the study.
753277|NCT00492063|Subjects were enrolled at 5 sites in Poland.|All enrolled subjects were included in the trial.
753278|NCT00492024|The study was conducted at 37 investigative centers in the United States from January 2005 to March 2008.|Modified Intent-to-Treat (MITT): Subjects who received at least 1 dose of study drug with a baseline sinus culture positive for at least 1 of 5 common bacteria that cause sinusitis (73 moxifloxacin [M], 45 placebo [P]). Per protocol (PP): Subjects with a positive baseline culture (as above) meeting a long list of additional criteria (62 M, 42 P).
753279|NCT00491894|First patient was enrolled on April 03, 2007 and last patient completed on May 30, 2008|After a washout and screening period, and 2-day baseline period, patients were enrolled in a 4-week dose titration period which commenced with the goal of identifying an optimal 3 times daily maintenance dose for each patient. The resulting individualized optimal maintenance dose was to be administered for the remainder of the 24-week study
753280|NCT00491829||
753281|NCT00491764||A total of 690 subjects were enrolled in the study and screened for eligibility. A total of 472 were screen-failures, leaving 218 subjects randomized to treatment.
753282|NCT00491751|Recruitment: May 2004 to June 2010.|
753283|NCT00491738||
753284|NCT00491608||Of 234 participants enrolled, 209 received study drug. Of those who received study drug, 200 had both baseline and post-baseline immunogenicity evaluations.
753285|NCT00491556|This research was conducted at 23 clinical sites. Accrual was open between August 2007 and June 2010.|
753286|NCT00491530|Subjects who had completed ABT-335/statin therapy in the preceding open-label year 1 study at a subset of sites were eligible for recruitment in this open-label year 2 extension study. Subjects continued to receive the treatment they had received in the preceding open-label year 1 study.|
753287|NCT00491504||
753288|NCT00491491||
753289|NCT00491400|Patients meeting the entry criteria were recruited at Boston Medical Center.|101 patients were consented and underwent screening. 73 were excluded because testing demonstrated that they were ineligible. 28 Entered the study 9 withdrew from the study
753290|NCT00491387|The study was stopped early due to concerns resulting from a publication reporting an increased in mortality in cardiac deaths in patients treated with beta-blockers as the primary drug for hypertension. Although no adverse reactions were observed in the present study, it was decided by the PI that beta-blockers could not ethically be continued.|
753291|NCT00491374||No subject fulfilled the requirements for randomized assignment of treatment; thus, no subject was assigned an intervention, and no subject was treated. The trial was terminated.
753292|NCT00491322|Subjects were enrolled from 2006-2008. Subjects were healthy volunteers recruited from the community|
753293|NCT00491244|Recruitment from 1 June, 2007 to 9 May, 2012 Location: 8 academic centers in Taiwan|
753294|NCT00491179|Recruitment period: June 2006- June 2007 Location: 5 academic centers|Wash out period: 6 months after last interferon intervention
753295|NCT00491075|Recruitment Period: December 13, 2005 through January 02, 2009. Participants were recruited from the UT MD Anderson's Genitourinary (GU) Cancer Center medical clinic.|
753296|NCT00490971||The double-blind (ie, niether physician nor patient knows the treatment that the patient receives) study has 15-week acute/continuation phase followed by variable-duration maintenance phase (lasting until patient had recurrence or discontinued treatment) to assess effect of paliperidone on maintenance of remission of Bipolar I Disorder
753297|NCT00490945||Number of Enrolled Subjects = 45 Number of Enrollment Failures = 6
753298|NCT00490919|Study dates: 27-Jun-2007 (first patient first visit) to 24-Jul-2008 (last patient last visit), at 86 medical/research sites in the USA.|The open-label run-in period (N = 1024 started) was designed to select subjects for randomization in the double-blind phase who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).
753299|NCT00490841|All subjects admitted for percutaneous renal artery revascularization were considered for enrollment at sites throughout the USA. Dates of enrollment: August 31, 2007 through October 02, 2009.|Subjects required to have documented uncontrolled hypertension (SBP at least 140 mmHg or DBP at least 90 mmHg, or both) in the presence of at least two (2) or more antihypertensive medications, all clinical eligibility criteria had to have been met and sujects had to sign the informed consent form. Intent to treat (ITT) population.
753300|NCT00490815||
753336|NCT00489255|Patients were recruited at 24 investigational sites in the United States (US).|"Number of participants STARTED does not match Enrollment, Actual (in protocol section) due to re-randomization design of the study & phased withdrawal of subjects from Tigan to placebo. Some subjects were included on one treatment in one period and re-randomized to a different treatment in a later period."
754648|NCT00418093||
753301|NCT00490802|Participants were recruited through advertisements in local media. Diagnosis was established using the Diagnostic and Statistical Manual, Fourth Edition criteria for an Autism Spectrum Disorder supported by the Autism Diagnostic Observation Schedule and the Autism Diagnostic Interview - Revised performed by research-reliable administrators.|This was a randomized, double-blind, placebo-controlled, parallel design trial of intranasal oxytocin versus placebo in adults with Autism Spectrum Disorder. As such, there were no participants excluded after enrollment but prior to assignment to groups.
753302|NCT00490724||67 participants provided consent, out of these 61 participants were assigned to the study treatment.
753303|NCT00490698|Recruitment Period: October 1, 2006 to January 31, 2008. All recruitment done at UT MD Anderson Cancer Center.|
753304|NCT00490646||
753305|NCT00490568|A open-label extension study to evaluate the long-term safety and tolerability of rosiglitazone extended-release (RSG XR) tablets in participants with mild-to moderate Alzheimer's Disease conducted in a total of 29 countries across 267 centers from 08 August 2007 to 30 May 2009.|Approximately 1800 participants were planned to be enrolled however a total of 1461 participants (after completing parent studies AVA102670/AVA102672) were enrolled and received open-label RSG-XR tablets.
753306|NCT00490555|Healthy male volunteers, 25-55 yr old, were recruited via advertisement: flyers on University campus and newspaper ads.|
753307|NCT00490542||
753308|NCT00490529|Some participants started study procedures, but did not receive the intended study treatment.|
753309|NCT00490490||
753310|NCT00490477||
753311|NCT00490451||
753312|NCT00490282|Recruitment Period: June 20, 2007 to November 09, 2010. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.|
753313|NCT00490269|Recruitment was from October 31, 2006 to December 5, 2007. The study was conducted at the NIDA funded clinical pharmacology unit (CPU) at Uniformed Services University for the Health Sciences (USUHS).|Volunteers meeting the maximum 28-day screening assessment period and eligibility criteria were enrolled into the Phase-1 clinical trial. The subjects had to meet the following criteria to be eligible: be non-treatment seeking, experienced marijuana users with dependence for the past year, and subjects that were in good general health.
753314|NCT00490256||
753315|NCT00490139||Treatments administered differed per timing/type of adjuvant chemotherapy. Design (D) 1: (neo) adjuvant anthracycline-based chemotherapy (AABC) prior to targeted therapy (TT); Design 2: TT concurrently with paclitaxel or docetaxel, after completion of a (neo) AABC; Design 2B: TT concurrently with chemotherapy with docetaxel and carboplatin.
753316|NCT00490100||
753317|NCT00490061|Recruitment took place in a radiation oncology clinic, in a private room. The recruitment period spanned from 7/26/2007-11/18/2011.|# of subjects were screened.
753318|NCT00490035|This study started to enroll subjects in September 2007 and concluded in February 2009.|Participant Flow refers to the Randomized Set.
753319|NCT00490022|Up to 55 normal, healthy men between the ages of 35-55 will be recruited for this study. All subject activities will occur at the University of Washington in Seattle Washington.|Subjects must meet all study protocol inclusion criteria such as informed consent, normal lab values, normal physical examination and normal prostate ultrasound, and not have exclusion criteria such as a first degree relative with or personal history of prostate cancer, PSA >2.0 or a history of a bleeding disorder or need for anticoagulation.
753320|NCT00490009||
753321|NCT00489970|A total of 1592 participants were enrolled in the study at Year 1 (in the Boostrix and Adacel groups). As per advice from the Centre for Biologics and Research Evaluation (CBER), an additional treatment group acting as control was also added at Year 9, therefore the total number of subjects analyzed was 1592 (Year 1) + 362 (Year 9) = 1954.|Subjects who received a single dose of Boostrix or Adacel vaccines, in the primary study (NCT00346073) were included in this study.
753322|NCT00489918||
753323|NCT00489866|Subjects were recruited for participation from 4/07 through 12/08. The study was closed to enrollment on 12/08.|This was a randomized, placebo-controlled study.
753324|NCT00489853|Patients were recruited in 12 centers in Germany and 12 centers in Switzerland.|Among 137 enrolled patients, 26 patients were not randomised (14 due to violation of inclusion/exclusion criteria, 2 due to adverse events, 1 due to development of study-specific discontinuation criteria, 7 due to voluntary discontinuation, 1 due to lost to follow-up, and 1 due to other reason.)
753325|NCT00489827|4 patients, 2 in each group were excluded because of intraoperative exclusion criteria|
753326|NCT00489736|Enrollment of patients started on June 12, 2007 and was completed on October 3, 2008. The study was conducted in 112 centers in 23 countries. Minimum duration of treatment was 6 months. Minimum duration of observation was last patient's randomization plus 190 days.|Planned sample size was 472. Six hundred and eighteen patients (618) were screened of which 113 did not verify one or more selection criteria. One eligible patient received a placebo capsule (morning intake in the amiodarone group) but was not randomized in the trial. This patient did not report any adverse event and was excluded from all analyses.
753327|NCT00489554||
753328|NCT00489541|Eligible subjects were enrolled at 28 United States centers between July 13, 2007 and August 27, 2008. All subjects were required to undergo angiographic assessment at 9 months. The historic control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522), including 108 with 9-month QCA follow-up.|
753329|NCT00489489|The recruitment initiated in May 2007 was completed in August 2008. A total of 159 patients were screened at 29 sites in 5 countries.|"Randomization was stratified by country and dose level of interferon-β (high/low).
~Assignment to groups was done centrally using an Interactive Voice Response System (IVRS] in a 1:1:1 ratio after confirmation of the selection criteria.
~118 participants were randomized."
753330|NCT00489476||
753331|NCT00489424||
753332|NCT00489411||The number of screened and the number offered participation but declined was not captured.
753333|NCT00489359||Phase 1 and Phase 2 were conducted in different participants (i.e., Phase 1 participants did not also participate in Phase 2).
753334|NCT00489281||One participant was a screen failure.
753335|NCT00489268||
753701|NCT00467831|Participants were recruited from April 2007 to November 2012 at the NIH Clinical Center.|
758025|NCT00177970|Enrollment number retrieved from old IRB database and not from study records and cannot be verified.|
753337|NCT00489216||Patients with evidence of an inflammatory, erythematous rash and skin biopsy consistent with cutaneous Graft-Versus-Host disease who had failed to improve after at least 4 weeks of methylprednisolone at 0.5mg/kg were eligible for enrollment.
753338|NCT00489086||
753339|NCT00488982||Patients had to complete 6 cycles of induction chemotherapy and have a ≥ 50% decline in prostate-specific antigen to be eligible for randomization.
753340|NCT00488865||
753341|NCT00488826|Subjects were recruited in China from September 2006 to May 2007.|Subjects were enrolled into study according to inclusion/exclusion criteria without a screening period.
753342|NCT00488774||
753343|NCT00488683|Subjects were enrolled at one study center in the UK.|All enrolled subjects were included in the trial.
753344|NCT00488644|Recruitment Period: February 16, 2006 to September 10, 2008. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.|
753345|NCT00488631||Efficacy results are based on participants who were Golimumab induction responders (GLM-I-Rsp) and were randomly assigned to GLM-I-Rsp-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg and GLM-I-Rsp-Golimumab 100 mg as per planned analysis.
753346|NCT00488618||
753347|NCT00488592||
753348|NCT00488514||
753349|NCT00488488|Non-interventional study; participants were selected and treated according to the usual clinical practice of their physician.|A total of 1,028 participants were documented at 137 observational sites. Three participants were excluded from analysis due to retrospective documentation.
753350|NCT00488475||
753351|NCT00488345||Fifty-nine participants were screened and enrolled in the study, and 58 participants received at least 1 dose of tigecycline.
753352|NCT00488319|This study evaluated the long-term (2 year) safety and tolerability of paliperidone extended release (ER) in adolescent patients with schizophrenia. This study was conducted from 27 June 2007 to 18 July 2012 at 55 centers in 10 countries. A total of 400 patients received at least 1 dose of the study drug and were included in the safety analysis.|Patients enrolled in this study came from 3 different sources: patients who enrolled directly, patients who were randomly assigned to placebo in the R076477PSZ3001 (NCT00518323) study, and patients who were randomly assigned to paliperidone ER in the R076477PSZ3001 (NCT00518323) study.
753353|NCT00488293|Recruitment occurred between 2008 and 2011.|
753354|NCT00488059||Phase I of the study was a single group. In Phase II of the study, the remaining patients were randomized to either the enfuvirtide (90 mg) BID group or the enfuvirtide (180 mg) QD group.
753355|NCT00488033||
753356|NCT00487981||
753357|NCT00487942|Eleven centers in the United States (US). First participant enrolled: July 2007 / Last participant last visit: December 2007|The study consisted of a screening period of at least 1 week, a 4 week double blind treatment period, and a 1 week follow up period. Of the 60 patients enrolled, 59 patients received at least 1 dose of study drug and were evaluated for safety; 1 patient who was assigned to receive placebo withdrew before taking any study drug.
753358|NCT00487825|A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment and to determine a biomarker profile in responders to Canakinumab plus MTX as com-pared to MTX alone in early rheumatoid arthritis patients. Study starting 16-Mar 2007 and ending 19 Dec 2008.|
753359|NCT00487747|The study was conducted at 7 centers in Russia.|Out of 20 participants, 18 were included in the study. (4 were Hepatitis B Early Antigen [HBeAg] positive and 14 were HBeAg-negative).
753360|NCT00487721|Twelve patients were recruited from the urologic oncology clinic at the University of Colorado Hospital between October of 2006 and October of 2007.|All patients were newly diagnosed with prostate cancer and planning to pursue surgical radical prostatectomy. Patients were excluded from participation if they had received previous treatment for prostate cancer or if their surgery was scheduled within 14 days.
753361|NCT00487695|Recruited from April 2007 to May 2008 from the gastroenterology clinics at Johns Hopkins University.|None of the patients enrolled were excluded prior to group assignment. 1 patient dropped out prior to the first procedure.
753362|NCT00487669||
753363|NCT00487578|Subject enrollment started in 2006 at Site 1 (headache specialty clinic). Subjects were never enrolled at 2nd site (hospital rehabilitation center). Sites 3 (pain clinic) and 4 (hospital rehabilitation center) were added in 2008. Enrollment continued until study termination October 2009.|19 participants were screened. 7 were Screen Failures.
753364|NCT00487565|Between September 2006 and February 2011, 210 subjects were recruited and enrolled at 4 clinics by orthopaedic surgeons. Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.|This was a non-randomized study so all subjects that met the inclusion/exclusion criteria received the LCS Complete Posterior Stabilized implant. Consented subjects could be excluded from the trial based on results of pre-operative clinical and/or radiographic evaluations, as per the exclusion criteria in the clinical investigation plan.
753365|NCT00487552||
753366|NCT00487539||Participants were assigned to Placebo, Golimumab 100 mg->50 mg, Golimumab 200 mg->100 mg and Golimumab 400 mg->200 mg groups for dose selection. Efficacy results were reported for only newly enrolled participants assigned to Placebo, Golimumab 200 mg->100 mg and Golimumab 400 mg->200 mg groups after dose-selection as per planned analysis.
753367|NCT00487461||
753368|NCT00487435|The recruitment period for this out-patient, multicenter study occurred between 4 June 2007 and 29 June 2009.|
753369|NCT00487396|Study started on September 2007 and data collection completed on October 2010. Study conducted in 10 clinical sites (hospitals and private clinics) in the USA, Sweden, Canada and Israel|"98 patients enrolled in this study. 18 cases excluded due to the following: 15 cases were excluded due to noncompliance with the protocol.
~1 patient withdrew consent before any study procedure.
~1 patient could not ingest the capsule.
~1 patient refused to undergo the ileocolonoscopy and SBFT. Therefore 80 patients were included in the analysis"
753370|NCT00487279||
753371|NCT00487240||First 4 weeks (Titration Period): acclimate patients to insulin regimen and optimize insulin dose. Final 28 weeks (Maintenance Period): Minimum of 6 months' stable insulin dosage. 456 patients were screened; 69 did not meet entry criteria and 387 were randomized; 6 patients were excluded from the 387 randomized to create the Full Analysis Set.
753743|NCT00465595|Participants were recruited through flyers, internet, and physician referral.|
753372|NCT00487188|A total of 47 patients were enrolled into the study at 20 investigational sites in France, Italy, Spain, Mexico, Germany and the US. Study starting 15NOV2005 and ending 5NOV2007.|In the Induction Phase participants were randomized (2:1 ratio) to receive ENF + HAART or HAART. In the Maintenance Phase participants in the HAART group who responded (viral load < 50 copies/mL) continued to receive HAART; those who responded in the ENF + HAART group were re-randomized (1:1 ratio) to receive ENF + HAART or HAART (ENF removed).
753373|NCT00487162|enrollment period 6/07-3/09. potential subjects were recruited from the pre-operative admission unit and were screened if there ages were 18-90,undergoing general anesthesia for surgical procedures greater than 2 hours.|Subjects were randomized to a specific study arm based on a computer generated randomization table. 49 participants are included in the baseline characteristic module because although 56 signed consent, some subjects withdrew the consent prior to study procedures and several withdrawn by attending anesthesiologist.
753374|NCT00487084|136 subjects approached and assessed for eligibility|Excluded from randomization (n=37), 26 refused to participate, 11 did not meet exclusion criteria
753375|NCT00486954|This study consisted of a Pilot part and a Randomized part. The Pilot part and the Randomized part had two separate participant (par.) populations. The study period of the Randomized part was from 31 March 2008 to 5 January 2012 (cut-off date for efficacy). Follow-up was conducted until 30 October 2012 (cut-off date for safety analysis).|In the Pilot part, par. were enrolled in this study based on their gastrectomy status: non-gastrectomy (intact stomach), partial gastrectomy (gastrectomy with pylorus preserved), and gastrectomy (pylorus removed). However, no par. with partial gastrectomy were enrolled. In the Randomized part, par. were randomized to two treatment arms.
753376|NCT00486902|The trial was conducted at Prentice Women's Hospital between August 2006 and November 2006.|188 subjects were recruited for the study. 5 subjects in the ketamine group and 3 in the saline group were excluded after randomization but before study drug administration.
753377|NCT00486863|Participants were otherwise healthy schistosomiasis-infected women at 12-16 weeks gestation, recruited from approximately 50 schistosomiasis-endemic villages served by 6 municipal health centers in Leyte, The Phillipines. Participants were enrolled between 13Aug2007 and 5Nov2012.|
753378|NCT00486837|This study was performed in 8 study centers in Germany.|Subjects inhaled saline once daily for 2 weeks during the Run-in Period.
753379|NCT00486824|A total of 29 patients were initially consented and enrolled. Patients were enrolled through December 2012 but protocol remained open until 2018. Due to patient privacy regulations, the data were accessible for only 10 patients.|
753380|NCT00486811|First participant was enrolled on 04 June 2007 and the last participant out was on 18 July 2008.|
753381|NCT00486759||
753382|NCT00486720|Date of first patient in was 26-Jun-2007. The date of last patient last visit for the study was 16-Jul-2009.|"Vorinostat was studied in patients who were first stratified by their International Prognostic Scoring System
~for myelodysplastic syndrome (low versus intermediate-1) and than randomized into one of two dose schedules."
753383|NCT00486642||
753384|NCT00486603|This study was conducted by the Adult Brain Tumor Consortium (ABTC) and patients were recruited from the consortium members outpatient centers.|
753385|NCT00486525|We enrolled a sample of 200 breast cancer survivors with respect to age, stage of cancer, and treatment modalities between October 2007 and April 2012 in the Ohio State University Medical Center. Women were recruited through oncologists' referrals, community print and web-based announcements, and breast cancer groups and events.|We assessed functional limitations during the screening session. Those who had mobility/functional limitations were dropped out before randomization.
753386|NCT00486447||
753387|NCT00486434||
753388|NCT00486330|Subjects were recruited from buprenorphine maintenance treatment in New Haven over a year period. Subjects were hospitalized at baseline to be stabilized on buprenorphine/naloxone (BUP/NLX) therapy.|There were no pre-assignment exclusion criteria.
753389|NCT00486291|Subject recruitment occurred in 10 investigative sites in the U.S. between May 2007 and July 2007|
753390|NCT00486278|A total of 40 sites were initiated globally in 18 countries, including Argentina, Brazil, Canada, Croatia, France, Hungary, Israel, Italy, Japan, Malaysia, Poland, South Africa, Spain, Turkey, Taiwan, Thailand, the United Kingdom and the United States|A subject could be included in more than one dose escalation cohort with up to one bleeding per cohort, randomised by 4:1 to receive either vatreptacog alfa or rFVIIa 90 (mcg/kg) in a blinded manner.
753391|NCT00486265|Participants were recruited at 4 study sites in the United States and 1 study site in Canada between July 2007 and February 2009 [Part A] and between March 2009 and July 2009 [Part B].|Following enrolment there was screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with AZD4877
753392|NCT00486252||
753393|NCT00486226||
753394|NCT00486044|Middle-aged adults with parental history of Alzheimer's disease were recruited for this single-site trial (Madison, Wisconsin) from the Wisconsin Registry for Alzheimer's Prevention (WRAP) or the community through newsletters, websites, educational talks, health fairs, local clinics, and newspaper and magazine advertisements.|103 participants enrolled in the trial and 100 were randomized to treatment (1 no longer met inclusion criteria, 2 declined participation).
753395|NCT00486031||
753396|NCT00486018|"Please note that although the table below is titled Overall Study, the completion rates are for the 6-month Treatment Period only (i.e., does not include the 6-month Observation Period data)."|
753397|NCT00485953||
753398|NCT00485836|"Please note that although the table below is titled Overall Study, the completion rates are for the 6-month Treatment Period only (i.e., does not include the 6-month Observation Period data)."|
753399|NCT00485758|"First Patient In:13-Aug-2007, Last Patient Last Visit:15-Jan-2009
~Ninety-four (94) sites participated: Australia 2 sites; Belgium 7 sites; Canada 6 sites; Ecuador 2 sites; Finland 2 sites; Germany 8 sites; Israel 4 sites; Italy 3 sites; Malaysia 5 sites; New Zealand 4 sites; Portugal 4 sites; Sweden 10 sites; Taiwan 5 sites; United States 32 sites"|Patients with Type 2 Diabetes who were not at protocol specified low-density lipoprotein cholesterol goal of <115 milligrams/deciliter at screening, had a 4-week run-in period of lipid modifying therapy. In order to advance to randomization, patients had to meet the low-density lipoprotein cholesterol goal.
753400|NCT00485732||
753401|NCT00485693||
753817|NCT00461786||
753402|NCT00485589||The study population comprised adult patients with active rheumatoid arthritis (RA) of at least 3 months' but less than 5 years' duration who were naïve to methotrexate. Additionally, patients were required to be naïve to any biologic therapy for RA prior to enrollment.
753403|NCT00485485|Overall Study Recruitment: 1/18/2007 - 3/18/2008. All recruitment done at UT MD Anderson Cancer Center.|Patient has received any other investigational agents within 30 days of first day of study drug dosing; Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing.
753404|NCT00485472|Trial utilized an adaptive 3-stage group sequential design. The Data Monitoring Committee had recommended to stop the trial after the first stage due to lack of efficacy. Results refer to the entire population randomized until discontinuation of study (including overrun).|Of the 194 enrolled subjects, 149 subjects have been randomized until trial termination. The Participants flow refers to the randomized population. Of the 149 randomized subjects, 148 subjects have been treated and are included in the safety population, 145 have been included in the ITT population (Full Analysis Set).
753405|NCT00485433||
753406|NCT00485303||
753407|NCT00485264||
753408|NCT00485173|Five subjects in investigational group and 4 subjects in control group died within 24 months postoperatively. Among them, however, one investigational subject who died at 20 months and one control subject who died at 23 months reported some data that were included as the 24-month evaluation. Thus, they were counted as evaluated at 24 months.|
753409|NCT00485134||
753410|NCT00485069||52 weeks of Treatment Phase, consisting of 4 weeks of Fixed Titration Phase and 48 weeks of Flexible Titration and Maintenance Phase, was started after 1 to 4 weeks of Screening Phase. Although the results are presented by participants with and without L-dopa, this study was a single-arm design, and L-dopa was not the investigational product.
753411|NCT00484939||
753412|NCT00484874||
753413|NCT00484679||
753414|NCT00484419|Subjects were recruited from 18 May 2007 to 14 December 2007 at 6 sites in Colombia, 7 sites in Mexico, and 20 sites in the United States of America.|Subjects on metformin-combination therapy entered a 4-week washout period from non-metformin antidiabetic drug. Population is type 2 diabetes mellitus subjects on stable metformin regimen, who discontinued other antidiabetic drugs, glycemia not controlled, and low-density lipoprotein-C (LDL-C) >=60 mg/dL and triglycerides <500 mg/dL
753415|NCT00484393||
753416|NCT00484354||
753417|NCT00484315|Enrollment of 1264 subjects was planned; 1262 (942 TAXUS Element and 320 TAXUS Express) were enrolled and randomized at 90 centers by October 1, 2008. A total of 330 subjects were randomly assigned to protocol-mandated 9-month angiographic follow-up (angiographic subset).|
753418|NCT00484289||
753419|NCT00484185||
753420|NCT00484159|151 patients with axial low back pain and suspected lumbar facet arthropathy were recruited from pain clinics at Johns Hopkins and Walter Reed between January 2007 and April 2009 for lumbar facet interventions.|Subjects had to be candidate for facet blocks or radiofrequency denervation. They had to have no neurological symptoms, failed conservative treatment and not had spinal fusion.
753421|NCT00484094|Participants were enrolled between July 2011 and June 2015 from Korean health care centers.|
753422|NCT00483938||
753423|NCT00483756||Initially 7 participants were enrolled and randomized under original protocol but enrollment was terminated because 2 participants developed Grade 2B rejection. Protocol amendment 1 was implemented to increase aggregate level of immunosuppression and 331 participants were enrolled. Results of participants enrolled under amendment 1 are reported.
753424|NCT00483717|5 months and 3 weeks; Medical Centers and Hospitals|
753425|NCT00483704||
753426|NCT00483652|Patients with Multiple Sclerosis, enrolled at medical and MS clinics in USA and Canada; enrollment started 22 May 2007; last patient completed on 27 Feb 2008|Two weeks of single-blind placebo run-in to establish baseline walking speeds
753427|NCT00483574|Participants were enrolled from 30 May 2007 to 28 March 2008 at 82 US clinical centers.|A total of 1378 participants met inclusion and exclusion criteria, of which 1374 were vaccinated and included in this analysis.
753428|NCT00483561||
753429|NCT00483548||
753430|NCT00483509|Study period: February 14th, 2007 (first enrolment), April 23rd, 2010(last enrolment); May 17th, 2011(LPLV) 5 clinical sites in Italy|Planned sample size n.: 27 patients; Patient screened n.:28; Patient screening failure n.: 0
753431|NCT00483496||
753432|NCT00483405||Of the 33 enrolled; 2 patients withdrew or refused prior to the beginning of protocol therapy, 2 patients were found to be ineligible, and 1 patient was withdrawn when diagnosis changed to sarcoma.
753433|NCT00483379||Fourteen participants were screened and enrolled; however, one withdrew before receiving any study infusions due to the burden of weekly trips to the medical center.
753434|NCT00483327|From May 2007 to April 2012, total 31 patients were recruited to the study from New York University medical center and its affiliated hospitals.|One patient withdrew before the start of the treatment; ony 30 patients started the treatment.
753435|NCT00483262|Between June, 2007, and December, 2009, we enrolled patients into our open-label, dose-escalation study at three centres in the USA (Dana-Farber Cancer Institute, Boston, MA; Washington University, St Louis, MO; and the University of Michigan, Ann Arbor, MI).|
753436|NCT00483223||
753437|NCT00483184|Eighty four Behcet's Disease patients were followed at the rheumatology or dedicated BS outpatient clinics of 4 medical schools in Turkey.|Consecutive patients aged 18-75 fulfilling Behçet's disease International Study Group criteria (16) with the presence of active oral ulcers (OU) within the previous year were included. A further requirement was the presence of at least 2 OU accessible to measurement and with a total diameter of at least 4 mm.
753438|NCT00483119||
753439|NCT00483041|A total of 11 adult participants participated in the study between 19Jul2007 and 15Oct2008 at 2 sites in the United States of America.|Treatment assignments were determined using a block randomization procedure with a 1:1 ratio through an interactive voice response system. Only participants who had detectable levels of interleukin-9 in the Baseline Visit 2' bronchioalveolar lavage sample will be randomized.
753440|NCT00483002||
753441|NCT00482911||
753442|NCT00482729|First Patient In: 26-Jun-2007; Last Patient Last Visit for end of study: 28-Apr-2009; Two-hundred four medical clinics in the United States (US) and 5 in Puerto Rico.|Patients 18-78 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (hemoglobin A1c [A1C] >7.5% at screening visit) who were appropriate for treatment with oral antihyperglycemic therapy and had not been on an anti-hyperglycemic agent (AHA) in the last 4 months were eligible to participate.
753443|NCT00482703||
753444|NCT00482677||
753445|NCT00482625||
753446|NCT00482612||
753447|NCT00482547|Twenty Investigators at 20 Investigative Sites enrolled a total of 1188 study subjects between June 28, 2007 and June 23, 2008.|Subjects judged by site personnel to require a urinary catheter for at least 48-72 hours were screened against the study inclusion/exclusion criteria. Those subjects meeting these criteria were offered participation in the study.
753448|NCT00482391||
753449|NCT00482274|Three subjects were enrolled between 11/08 and 4/09 from the oncology clinic at OHSU. Enrollment was terminated on 11/30/09, when the sponsor withdrew funding for this study.|
753450|NCT00482170||
753451|NCT00482053||
753452|NCT00482014||
753453|NCT00482001||
753454|NCT00481988|Dates of recruitment period: 2006-2009 Location: community Approved sample size: 23 Total number of participants enrolled: 19|One patient was dropped by the investigator when he had a Hamilton Depression Rating Scale (HDRS) of 8 prior to baseline ratings (DRSS 20 is the minimum for inclusion in the study).
753455|NCT00481871|Patients were enrolled between May 2007 and July 2010 across 16 study sites, all in the United States.|12 patients were enrolled but not treated. Of these, 9 patients had events after enrollment that rendered them ineligible; 2 patients had progressive disease (PD); 1 patient withdrew consent. Since they were never dosed, these 12 patients were not included in efficacy or safety assessments.
753456|NCT00481845||
753457|NCT00481832||
753458|NCT00481767||
753459|NCT00481676||
753460|NCT00481507||
753461|NCT00481351||
753462|NCT00481247||Of the 547 patients enrolled, 519 were randomized and 516 received treatment. Of the 28 who were enrolled but not randomized, 20 no longer met study criteria, 3 withdrew consent, 1 was lost to follow-up, and 4 withdrew for other reasons.
753463|NCT00481195|42 centers in the US, Romania, Bulgaria, and Hungary. First participant enrolled: June 2007/ Last participant last visit: December 2008|The study consisted of a 1 to 2 week screening period, an 8 week double blind treatment period, and a 1 week follow up period.
753464|NCT00481078||
753465|NCT00481065|Participants were enrolled at 1 center in Colombia.|All subjects enrolled were included in the trial. A total of 405 subjects was enrolled and randomized into 8 groups in this study. The participant flow data are from the all randomized set.
753466|NCT00480987|Recruitment Period 1/15/08 - 11/3/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.|There were 27 participants registered and all were included in the analysis. The trial terminated early.
753467|NCT00480857||
753468|NCT00480779|Patients meeting the criteria for participation were referred by their health care provider, who also provided approval for moderate intensity physical activity. After completing informed consent, participants chose which mode of delivery they preferred, GLB-DVD or GLB-GROUP.|
753469|NCT00480740|Patients were recruited from cardiology outpatient clinic. The study is anticipating to enroll 104 patients.|74 subjects assessed for eligibility, 9 were excluded; 12 did not meet inclusion criteria; 12 refused to enroll; resulting in 41 subjects enrolled
753470|NCT00480636||
753471|NCT00480532|Recruitment at Oregon Health and Science University (OHSU) and University of Hawaii (UH|
753472|NCT00480493|Mothers recruited from 2 pediatric diabetes clinics in NE US,randomized 1:1 to either E or C. Of 118 mothers approached, 30 declined due to hectic schedules or had enough support; 28 (24%) passive no. 60 mothers completed the consent and baseline data, randomized to either E (32) or C (28).|
753473|NCT00480441|All recruitment was conducted in West Philadelphia, PA, at the University of Pennsylvania Treatment Research Center, a facility providing treatment to study participants, between the years of 2007 and 2009.|All participants were screened with a number of medical and psychiatric evaluations prior to randomization to determine if they met study criteria.
753474|NCT00480324||
753475|NCT00480077||
753476|NCT00480025|A total of 2315 patients were screened towards participation in the study. For 3 of these subjects informed consent forms issues were reported, and thus only 2312 subjects were considered for analyses/results Out of these 2312 subjects, 2278 were enrolled in the study.|Out of the 2278 patients initially enrolled into the study, only 2272 patients received at least one dose of study treatment (1515 received GSK1572932 and 757 received placebo).
753477|NCT00479882||Participants completed a 6-8 week washout then completed a 2-week placebo run-in prior to the start of active treatment. Includes 6 participants who had an adverse event that began during the placebo run-in but did not lead to discontinuation until after randomization in Period I or II.
753478|NCT00479856||
753479|NCT00479765||
753480|NCT00479713|"Phase IV
~First Participant In: 31-Mar-2007; Last Participant Last Visit 11-Mar-2008
~85 centers worldwide (EX US)
~Eligible participants include those on a stable dose of one of the following: rosuvastatin 5 mg; simvastatin 20 mg, 40 mg; atorvastatin 10, 20 mg; pravastatin 40 mg; fluvastatin 80 mg."|Eligible participants were randomized at Visit 2 (Week 6) to either a combination tablet of ezetimibe/simvastatin (10 mg/20 mg) plus a matching placebo for rosuvastatin 10 mg (Group 1) or rosuvastatin 10 mg plus a matching placebo for the combination tablet (Group 2) for a 6-week treatment period.
753481|NCT00479674||
753482|NCT00479557|Planned duration was approximately 110 weeks (including 6 week screening period, 52 weeks of dosing, and 52 weeks of follow-up). Participants who completed the 3134K1-200-EU (B2571004) study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol 3134K1-2203-EU (B2571007).|The Basic Results disclose pooled data from studies NCT00479557 and NCT00498602.
753483|NCT00479466||
753484|NCT00479401||
753485|NCT00479388|"First Patient In: 30-Jul-2007 Last Patient Last Visit: 10-Jul-2008
~Investigators: 161 sites participated: Australia-5; Austria-4; Canada-11; Czech Republic-5; Denmark-4; France-10; Germany-24; Hungary-6; Israel-4; Italy-11; Netherlands-2; Norway-10; Poland-11; Russian Federation-7; South Africa-9; Spain-4; Sweden-17; United States-17"|Patients on atorvastatin (10mg) or simvastatin (10mg or 20mg) had a 2 week run-in of their statin. Naïve patients or patients on other statins were started on simvastatin (10 or 20mg) or atorvastatin (10mg) for a 6 week run-in. Patients were eligible to be randomized if their Visit 1 low density lipoprotein cholesterol values were above goal.
753486|NCT00479336||
753487|NCT00479258|Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. Location = UNITED STATES.|Pfizer announced in Oct 2007 that it would stop marketing Exubera. At that time recruitment was placed on hold. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171083 was terminated and no further recruitment took place.
753488|NCT00479232||
753489|NCT00479154||
753490|NCT00479115||
753491|NCT00479089|Recruitment Period: From April of 2004 to November of 2007, fifty patients with metastatic or surgically unresectable urothelial cancer were enrolled at The University of Texas MD Anderson Cancer Center.|
753492|NCT00479037||82 subjects were randomized. Of these, one subject was randomized, but consent was withdrawn during the screening period; the subject did not receive any treatment. Therefore, the Intention to treat set (ITT) consisted of 81 subjects.
753493|NCT00478933||
753494|NCT00478881|Enrollment started on 31 August 2007 and the last study visit occurred on 13 November 2008. The study was conducted at 56 centers in 13 countries: 45 centers in Europe, 4 centers in Canada, 4 centers in Russia, and 3 centers in Israel.|Number of participants screened: 635. Number of participants enrolled and randomized (started Overall study): 397. Number of participants who had taken at least one dose (Safety population): 396.
753495|NCT00478777|A total of 150 participants in 37 sites in Germany were enrolled when lenalidomide became commercially available in Germany. Study completion (end of study) was the time point when participants discontinued study drug and could switch to commercial lenalidomide.|
753496|NCT00478673|Enrollment began on May 23, 2007. Enrollment was suspended on June 6, 2008, due to a voluntary recall of the NexStent Carotid Stent System. On June 17, 2008, enrollment was terminated and the NexStent Carotid Stent System was withdrawn from the market.|
753497|NCT00478647|The first participant was enrolled on 25 July 2007 and the last participant completed on 26 June 2009. Participants received the same dose of velaglucerase alfa (GA-GCB) as their previous dose of imiglucerase (range- </= 60 Unit per kilogram (U/kg) - >/=15 U/kg) every other week via intravenous infusion.|Participant at least 2 years old with documented diagnosis of type 1 Gaucher disease.Consistent treatment(every other week at a dose ≤/= 60 U/kg and ≥/= 15 U/kg) with imiglucerase for a minimum of 30 consecutive months;same dose during the 6 months prior to study enrollment.Minor dosing interval variance was allowed per standard clinical practice.
753498|NCT00478608|Patients were recruited in Korea from March 2007 to November 2007.|Patients were screened up to 7 days.
753499|NCT00478569|Participants took part in the study at 120 investigative sites in Austria, Denmark, Germany, Greece, Ireland, the Netherlands, Spain, and the United Kingdom from 1 April 2007 to 6 March 2013.|Participants with a diagnosis of osteoporosis and prescribed parathyroid hormone (PTH)(1-84) in a normal clinical setting were enrolled in this non-interventional study for 24 months observation. 1179 participants were enrolled however for 9 patients the data was missing.
753500|NCT00478556|Patients will be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally. The two agents will be prepared to have nearly equivalent iodine concentration.|
753501|NCT00478426||
753502|NCT00478361|Recruitment period: April 24, 2007 to November 10, 2011. All recruitment done within Community Clinical Oncology Programs (CCOP) medical clinics, specifically The University of Texas MD Anderson Cancer Center and the Ozarks Regional CCOP.|One patient withdrew from the study without receiving treatment.
753503|NCT00478335||
753504|NCT00478257||
753505|NCT00478244||All subjects were registered with the BMT Biostatistical Support Group at the University of Minnesota.
753506|NCT00478231||A total of 638 participants were screened, out of which 429 participants were screen failures and 209 were assigned to the study treatment.
753507|NCT00478218|Fifty-three (53) participants were recruited between July 2006 and August 2008 at Mayo Clinic.|
753508|NCT00478205||
753509|NCT00478192||One patient in the Placebo arm discontinued prior to dosing and therefore was not included in the Full Analysis Set (FAS) or the Safety Analysis Set (SAF).
753510|NCT00478140|Recruitment Period: May 30, 2007 to June 15, 2009. All recruitment done in medical clinics.|Of the 53 participants pre-screened only four participants were enrolled in the study.
753511|NCT00478062||
753512|NCT00478036|Prospective study participants will be identified by a routine clinic visit at Rocky Mountain Lions Eye Institute, University of Colorado, and need to undergo selective laser trabeculoplasty treatment for their glaucoma. A study investigator will make the initial patient contact for recruitment.|The patients enrolled in this study will follow standard of care practice in regards to selective laser trabeculoplasty with the exception that the patients will be randomized 1:1:1 (Acular LS: Pred Forte: Refresh Tears) to the inflammation treatment given after the procedure.
753513|NCT00478023|The recruitment period for this in-patient, multicenter study occurred between 19 May 2007 and 11 Mar 2008.|This trial consisted of 5 periods: a Screening (Day -28 to Day -4 to the Pre-operative Visit) a Surgical (Day -1 to 1), a Postoperative Qualification, a Double-blind Treatment(Day 1-4) and a Follow-up Period (4-14 days after the double-blind treatment). The results refer to randomized subjects.
753514|NCT00477971|From October 2005 to August 2012, 89 participants were recruited.|This study was originally designed as a randomized Phase III clinical trial; however the unwillingness of participants to be randomized to treatment led to changes. The protocol was amended to allow participants to choose between the two regimens.
754425|NCT00429169|Recruitment dates were 2/2005-7/2009 with follow-up completed in January 2010.|N=101 subjects enrolled, but N=23 did not return after enrollment, so N=78 were randomized.
753515|NCT00477750||This was as Phase I/II trial. There were 7 patients recruited to the Phase I portion; no patients qualified for the Phase II portion. Twenty-six (26) patients were recruited for the Phase II portion. Results presented here are on the 26 Phase II patients.
753516|NCT00477685||
753517|NCT00477672||
753518|NCT00477633|Recruitment began 21 Jun 2007|
753519|NCT00477607||
753520|NCT00477594|Patients who completed dosing in study 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) at a site in the U.S. with an acceptable safety profile, per Investigator judgment, were eligible to enroll in this study.|Patients who participated in Cohorts A, B, or C in study 301012-CS9 were randomized in a 1:1 ratio to mipomersen 200 mg once a week (QW) or 200 mg mipomersen every other week (QOW). Patients who participated in study 301012-CS8 or Cohort D of study 301012-CS9 received 200 mg mipomersen QW.
753521|NCT00477490|"Eighty-eight (88) sites were initiated in the United States and Canada, and 81 of these sites screened subjects; 78 sites enrolled and randomized subjects.
~A total of 1412 subjects were screened for Part I of the study; 613 subjects were screening failures."|"Potential subjects were given a sleep/voiding diary and urine collection device to record the time and volume of each void for 3 consecutive 24-hour periods.
~Randomization was stratified by age (<65, ≥65 years) and by the absence/presence of nocturnal polyuria, defined as a ratio of nighttime urine volume/24-hour urine volume ≥33%."
753522|NCT00477464||
753523|NCT00477451||
753524|NCT00477386|Eleven patients were enrolled in the dosing finding Phase I part of the study. The Phase II dose treatment phase had 17 patients enrolled. This was in line with what had been planned.|
753525|NCT00477334||
753526|NCT00477295||
753527|NCT00477269|Of the 42 participants that completed the Core Study only 22 Participants continued into the Open Label Extension. Not all participants were required to continue into the extension from the core.|
753528|NCT00477230|The study was terminated early by the decision of the Sponsor after 64 participants were enrolled and 25 were treated.|None outside of the protocol.
753529|NCT00477204|Dates of recruitment: baseline 12/20/07-2/9/10; all participants completed 6-month trial by 8/3/10. All study participants seen at a medical clinic in an area designated for clinical research.|We identified 105 potential subjects. Of these, 42 patients proved to be ineligible, 26 declined invitation to a screening visit, 16 were not able to be scheduled, and 3 were interested but ineligible for the study. Therefore, 18 agreed to be in the study and 17 subjects attended a study screening visit of which 9 were enrolled in the study.
753530|NCT00477191||
753531|NCT00477165||A total of 234 potentially eligible subjects were identified. Of these, 180 were excluded and 54 enrolled in the study, with 27 each randomized to citalopram and placebo.
753532|NCT00477152|Subjects recruited in emergency department after presenting with signs of mild to moderate dehydration|
753533|NCT00477087||
753534|NCT00476996|Participants were recruited across 25 countries.|The study population comprised of adult participants with active RA of >/= 3 months duration who had an inadequate clinical response due to toxicity or inadequate efficacy to previous or current treatment with one or more anti-TNF-alpha therapies.
753535|NCT00476957|8709 patients were randomized from May 2007 until December 2008 in 196 participating hospitals in 36 countries across five continents.|80 patients were excluded because there was no validly signed consent available during monitoring and 2 patients retracted their consent before the procedure, resulting in a total of 8709 patients randomised.
753536|NCT00476827|Subjects will be identified in cancer center outpatient clinics multi-site. The study will be introduced by a physician or caregiver known to the patient. We will need to review protected health information in order to identify subjects, and information resulting from this activity will be used only to assess eligibility of a subject.|to meet inclusion must be 2 wks from prior hormonal chemotherapy and radio-static surgery, 4 weeks since major surgery and 8 weeks from neuro surgery. excluded for prior tx with avastin or other anti-angiogenic therapy. Central Nervous system hemorrhage
753537|NCT00476788||
753538|NCT00476645||
753539|NCT00476593|Healthy subjects were recruited from students and staff at St. Olavs University Hospital and NTU for ophthalmic examination at the Department of Ophthalmology and mfERG testing at NTU, May 05- Sept. 07. From Sept.07 -sept.08 patients with uveitis were recruited from the Dep. of Opthalmology, healthy volunteers- both for OCT examination at the Dep.|We chose to focus primary on the OCT results because mfERG equipement was moved and its software was updated. MfERG results will be analyzed later. The main reason for participant exclusion in this study was either bad OCT scan quality or participant withdrawal because examinations turned out to be more time consuming then they thought.
753540|NCT00476476|Patients enrolled from February 2007 through July 2011.|
753541|NCT00476242||27 participants dropped during the inpatient detoxification, therefore only 55 participants were randomized out of the 82 total enrolled.
753542|NCT00476229|Recruitment period: July 14, 2006 to October 15, 2008. All patients were registered at UT MD Anderson Cancer Center.|
753543|NCT00476151||
753544|NCT00476086|20 participants were enrolled between May 2007 and August 2011.|
753545|NCT00476047||
753546|NCT00476021||
753547|NCT00476008|Recruitment dates July 2007 - September 2011 Newspaper print ads, physician referral, subject referral, press releases|Prior to randomization, subjects completed a screening visit to discuss/sign informed consent and determine study eligibility. Of the 60 subjects screened, 17 were excluded due to not passing the screening visit driving test, scoring out of the inclusion criteria range on screening visit assessments or meeting an exclusion criteria.
753548|NCT00475982||
753549|NCT00475904||
753550|NCT00475878||
753551|NCT00475865|"The recruitment initiated in April 2007 was completed in December 2008.
~A total of 148 patients were screened at 24 sites in 6 countries."|"Randomization was stratified by country.
~Assignment to groups was done centrally using an Interactive Voice Response System (IVRS] in a 1:1:1 ratio after confirmation of the selection criteria.
~123 participants were randomized."
753552|NCT00475852||Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)
753553|NCT00475787||
753554|NCT00475735|First Patient Dosed: 16 AUG 2007; Last Patient Last Treatment: 04 APR 2008. Six U.S. study centers.|Pre-Treatment consisted of 2 visits: Screening Visit1 & Baseline Randomization Visit2. Patients continuing after Visit1 entered a 1-wk placebo Run-in period. At Visit2, patients were assessed using the protocol eligibility criteria. Then, if deemed eligible, patients were randomized at Visit2 to one of six 2-period cross-over treatment sequences.
753555|NCT00475722||
753556|NCT00475709||
753557|NCT00475670||
753558|NCT00475657||
753559|NCT00475644||Participants who were considered to have completed the study who received at least 1 dose of study drug, did not have any protocol violations, and from whom a valid assay result was obtained.
753560|NCT00475501|Subjects were recruited between 7/2/2007 and 10/13/2010. Subjects responded to letters mailed to male patients aged 60 years or more who were seen at VA clinics.|Subjects were excluded if they failed brief cognitive testing (MiniCog), if serum testosterone > 300 ng/dL or less and bio-testosterone > 70 ng/dL, congestive heart failure, sleep apnea, hematocrit (HCT) > 49%, prostate specific antigen (PSA) > 2.6 ng/ml, were taking coumadin or had orthopedic limitations.
753561|NCT00475423||
753562|NCT00475332|This study was opened through UF's IRB-01 3/21/07 and closed 6/11/09 when the PI left UF. Two patients were enrolled in UF's Dept. of Radiation Oncology clinic.|
753563|NCT00475319|Subjects were recruited in Japan between 2007 and 2008|Participant flow results are based on the safety set.
753564|NCT00475306|Patients who presented to one ED with nausea were eligible for participation|
753565|NCT00475241||
753566|NCT00475228||Women undergoing D&E at 15 to 23 weeks of gestation were approached for enrollment. After completion of the D&E, women who consented were enrolled as long as there no contraindications to immediate IUD insertion. 88 out of the 93 subjects were randomized to either Arm I (immediate) or Arm 2 (delayed, 3 to 6 weeks later LNG-IUD insertion).
753567|NCT00475215|Participants were enrolled at 9 study sites in the United States.|
753568|NCT00475176|Twenty-four patients were enrolled at National Institutes of Health Clinic Center between October 2007 and April 2009.|
753569|NCT00475150|Between June 2008 and June 2011, 39 participants were accrued to this study.|A total of 23 AML (7 at 45 mg; 16 at 30 mg) and 16 MDS (all at 30 mg) were enrolled. The AML and MDS groups were analyzed for the primary endpoint separately.
753570|NCT00475085|Patients from 15 private-practice oncology groups in the USA affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program (URCC CCOP)were enrolled by research personnel from May 2007 to September 2010.|
753571|NCT00475033|Subjects were recruited in Canada from June 2007 through November 2007.|
753572|NCT00475020||
753573|NCT00474994||
753574|NCT00474968|Patients presenting for a previously scheduled colposcopy subsequent to an abnormal Pap result were recruited for this study.|
753575|NCT00474955|A total of 27 participants were enrolled in this study conducted from 2006 to 2011 at 5 centers in Russian Federation.|
753576|NCT00474929||
753577|NCT00474903|In total, 122 patients were randomized. Two patients withdrew due to an inadequate number of biopsies and a finding of high-grade dysplasia. Six participants were not evaluable for the primary endpoint due to sample-related issues (e.g., improper temperature, lost or delayed samples), leaving 114 evaluable participants for the primary endpoint.|Of the 120 participants in the intervention cohort, 114 were evaluable for the primary endpoint (n = 29, 42, and 43 in Arm I, Arm II, and Arm III, respectively).
753578|NCT00474851||
753579|NCT00474812|Patients were recruited from Cleveland, Ohio area hospitals, Case Medical Center University Hospitals and MetroHealth Medical Center.|
753580|NCT00474786||
753581|NCT00474760||
753582|NCT00474708|Participants were recruited in China from March 2007 to January 2008.|There was no screening period for this study. Screening was done by the investigator.
753583|NCT00474630||
753584|NCT00474617||
753585|NCT00474539|Participants were recruited in Spain from 4 July 2007 to 23 July 2007.|Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.
753586|NCT00474526||
753587|NCT00474487|Subjects were enrolled at 3 centers in Argentina and Colombia.|All subjects enrolled were included in the trial.
753588|NCT00474383|The 5 participants in the Extension Study received treatment until they experienced progressive disease.|
753589|NCT00474266||During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
753590|NCT00474253||
753591|NCT00474240|The study was performed from 05 November 2007 to 04 August 2008 at 17 medical clinics within the United States.|Subjects who were previously on a lipid lowering therapy underwent a 5-week washout period. All subjects were on a low-fat diet (<30% calories from fat) starting 5 weeks prior to study drug treatment and continuing for the duration of the study.
753592|NCT00474201|Up to 30 healthy volunteers will be screened to enroll a total of 15 healthy volunteers. We will actively encourage participation of all ethnic groups and females. Recruitment of HIV-negative volunteers will be done through the normal volunteer office at NIH.|Subjects who meet inclusion criteria and do not meet any exclusion criteria will be invited to participate in the study.
753593|NCT00474188||
753594|NCT00474175||
753595|NCT00474123|From July 2006 to January 2009, we randomized 78 patients with stable coronary artery disease (CAD) with LDL-C > 70 mg/dl, Angiographically documented CAD, stable angina, and age between 18 and 80 years. Patients were assigned randomly to two groups. The one group received Ezetimibe 10 mg/Simvastatin 20 mg the one other received Simvastatin 80 mg.|No wash-out period.
753596|NCT00474058|A total of 333 subjects were enrolled in this trial and comprised the Enrolled Set (ES). 287 subjects were randomized and all of them received at least 1 dose of trial medication, so they all belong to the Safety Set (SS). 267 subjects belong to the Full Analysis Set (FAS).|Participant Flow shows all 287 subjects who has been enrolled and randomized. Baseline Characteristics are described for the Full Analysis Set (FAS).
753898|NCT00457301|The recruitment started July 2005. Patients were recruited at the out patient clinic University of Alberta Hospital.|Pre-transplant patients were censored out of the study once they had the lung transplant.
753597|NCT00474045|Trial was conducted at 79 sites in 17 countries: Denmark, Finland, France, Ireland, United Kingdom, Norway, Croatia, Poland, Austria, Spain, Canada, Argentina, Brazil, South Africa, Russia, Israel and Australia.|Non-pregnant women were randomised immediately after it was established that they fulfilled the eligibility criteria. Thus, they were exposed to insulin detemir (IDet) throughout organogenesis. Pregnant subjects were to be randomised after completion of the 8th gestational week (GW) and before the completion of 12th GW
753598|NCT00473889|This study was conducted at 99 investigative sites worldwide. The first patient's first visit was 16 May 07 and the last patient's last visit was 12 Dec 2008.|Randomized participants were stratified by Stage (IIIB versus IV), geographic region and eligibility for treatment with bevacizumab prior to treatment assignment.
753599|NCT00473876|Patients with symptomatic CHF were recruited from out patient cardiology clinics and local echocardiography database. Eligible patients were approached to have a fasting blood test to determine their fasting insulin resistance index (FIRI). CHF patients with a FIRI >2.7 were considered to have IR and invited to participate in the study.|127 patients were invited for screening.53 patients were excluded based on exclusion criteria.12 patients decided not to continue with the study after screening.62 patients were randomised using a computer generated sequence.Metformin was started at lower dose of 500mg bd for 2 weeks. Doses were up titrated if well tolerated to the target dose.
753600|NCT00473837||
753601|NCT00473824|First enrollment: 14 May 2007 Last Subject completed: 16 February 2009 Three investigative sites, all Mayo Clinics|This was an open label, randomized study.
753602|NCT00473746|The study was conducted between 10 July 2006 and 22 December 2012.|66 participants participated in the study, including 33 participants enrolled in Phase 1 of the study, and 33 participants enrolled in Phase 2 of the study.
753603|NCT00473694|The trial was conducted in 8 trial sites in the United States. A total of 182 participants were randomized with 157 participants treated.|
753604|NCT00473668||Out of 300 subjects enrolled in the study, one did not receive any vaccination.
753605|NCT00473655|All participants where outpatients recruited from clinical centers. Recruitment began on August 2007 and ends on October 2008|Participants with informed consent signed, and all inclusion criteria with no exclusion criteria, entered the lead in period, where they received a low fat diet. After 4 weeks if they still had TGs above 200 mg/dl they entered the randomization phase.
753606|NCT00473642||
753607|NCT00473590|Phase II, randomized, blinded, placebo-controlled, multicenter study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patients with relapsed or refractory multiple myeloma starting 11 July 2007 and completing 9 November 2009.|
753608|NCT00473564||
753609|NCT00473512||
753610|NCT00473434||
753611|NCT00473382|Patients were recruited from study sites in the United States, Argentina, Peru, Columbia, Chile, and Peru. There were 47 patients from the Latin American countries.|
753612|NCT00473330|Patients were recruited from study sites in the United States and Argentina. There were 10 patients from Argentina.|
753613|NCT00473265|68 subjects were enrolled from 05/12/2004 to 06/19/2014 at Columbia University Medical Center.|The first 6 participants in the study were randomly assigned to PTH1-84 100mcg daily, 100mcg every other day, and 100mcg every three days as a pilot project to determine the correct dosing regimen.
753614|NCT00473083|Eligible patients had a histological or cytologic documented diagnosis of metastatic NSCLC, with and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. The study was initiated on November 7, 2008, and concluded with the last patient in December 2012.|
753615|NCT00472849|Recruitment Period 5/31/2007- 2/1/2012; All participants were registered at The University of Texas MD Anderson Cancer Center.|Of the 92 participants enrolled on this study, two participants were excluded as having failed screening and never received study medication.
753616|NCT00472797|232 subjects were recruited from 25 Multiple Sclerosis (MS) Clinics in the US from April 2007 through November 2007.|Run-in period (up to 30 days) on Rebif® 44 mcg tiw: The run-in period included a Screening Visit; assessments consisted of informed consent, medical/disease history, physical exam and laboratory assessments which were performed in the two-week period prior to Study Day 1, (prior to the first dose of a new formulation of rebif)
753617|NCT00472732||
753618|NCT00472641||
753619|NCT00472576|Patients were recruited to participate at the Clinical Center on the campus of the National Institutes of Health in Bethesda, Maryland.|24 patients were screened, 19 subjects were excluded as they did not meet criteria (total n=13) or refused to participate (n=6).
753620|NCT00472446||
753621|NCT00472420||
753622|NCT00472303|The trial started on 13 Jun 2007 with the enrollment of the first participant and was completed on 04 Jun 2012 with the last follow-up examination. 622 participants signed informed consent. 505 participants were randomized and 504 had at least one dose of trial medication. 496 participants were part of the safety analysis set.|"One site was excluded from all analysis sets (efficacy and safety) due to GCP non-compliance. Thus 8 participants who were randomized and treated are not reported in the tables below.
~The participants in the tapentadol titration phase were re-randomized to tapentadol or placebo in the maintenance phase."
753623|NCT00472290|This study was available to subjects who completed a previous romiplostim study for the treatment of thrombocytopenia in subjects with low or intermediate-1 risk MDS. First Subject Enrolled: 17-Jul-2007; Last Subject Enrolled: 15-Feb-2011|
753624|NCT00472199||Of 331 patients enrolled, 329 were treated with study drug. Two patients were randomized, but before their first intake of trial medication they decided to not participate in the study.
753625|NCT00472082|Subjects were recruited from population of stable renal transplant recipients being followed at the Emory Transplant Center|
753626|NCT00472056|Recruitment Period: March 03, 2005 to June 19, 2009. All recruitment done at UT MD Anderson Cancer Center.|
753627|NCT00472030||
753628|NCT00471887||
753629|NCT00471822||
753630|NCT00471718|This study began enrolling October 2004 through December 2007.|A total of 34 patients were consented in Phase I and Phase II, 7 of which were not eligible.
753899|NCT00457249|Participants were enrolled from 28 March to 30 October 2007, at 19 clinic centers in United States.|A total of 1563 participants were enrolled; 1561 were vaccinated with data analyzed and presented in this report.
753631|NCT00471705|The study was carried out between June 2006 and April 2008. The subjects of the study were adult males serving in the Colombian Army. The study was carried out in five military health establishments located in central, northeast and southern Colombia.|Screening was performed to 486 volunteers, of whom 49 were excluded for several reasons, as follows: Failure to meet inclusion criteria (n=12), unwillingness to participate (n=14) and completion of military service within 6 months (n=23)
753632|NCT00471536|Nineteen participants were accrued between October 2008 and December 2009.|Of the 19 participants accrued, one participant canceled prior to treatment evaluation, and therefore was excluded from toxicity analysis. This participant was included in the primary endpoint analysis.
753633|NCT00471497|The study over-enrolled, and 846 patients (283 in the imatinib 400 mg arm, 282 in the nilotinib 300 mg arm and 281 in the nilotinib 400 mg arm) were randomized. DP = disease progression, SOR/TF = Suboptimal response or treatment failure|Randomization was planned for a total of 771 patients.
753634|NCT00471445||
753635|NCT00471380|46 patients suffering from POAG or ocular hypertension, with an intraocular pressure that was insufficiently controlled were recruited.|Subjects meeting the inclusion/exclusion criteria were enrolled.
753636|NCT00471354||
753637|NCT00471328|Patients ongoing on treatment at primary analysis had option to enter extension. Patients in control arm were allowed cross over to Nilotinib arm at disease progression and considered as part of extension. Patients entering the extension part on control arm were permitted to cross over to the nilotinib only upon documented disease progression.|
753638|NCT00471315||
753639|NCT00471276||
753640|NCT00471237|The study was conducted between 14-May-2007and 26-December-2008 at 45 centres in 14 countries.|Of the 1609 participants screened, 1040 were screen failures, remaining 569 were randomized to the treatment arms. One participant from each of the 4 ronacaleret groups and alendronate group were excluded from Intent-to-Treat population and 564 participants were included in Intent-to-Treat population.
753641|NCT00471146||
753642|NCT00471107|Healthy subjects were recruited through the NIH Clinical Research Volunteer Program|Nothing to report
753643|NCT00471081|A total of 196 subjects were enrolled and randomized in the GSK 134612 1 dose Group at the study start but 36 subjects were not vaccinated, due to the 3-month period between enrollment and vaccination.|The majority of subjects withdrawn in the active Phase were still contacted for the safety follow-up, therefore the subjects listed as withdrawn were not necessarily the same individuals in the two phases (Active Phase and Extended Safety Follow-Up).
753644|NCT00471068|Recruitment period: from 13-03-2007 to 30-11-2007 Recruitment restarted on 27-03-2008 to 27-05-2008 First patient first visit: 19-03-2007 Last patient last visit: 29-05-2008|After completing the run-in, 8 patients were not randomized: 7 patients did not meet entry criteria and 1 patient was excluded by sponsor's decision.
753645|NCT00470847|Participants were recruited between May 2007 and December 2009.|
753646|NCT00470834||
753647|NCT00470626||
753648|NCT00470600||
753649|NCT00470574||
753650|NCT00470548||
753651|NCT00470535||
753652|NCT00470470|"Protocol Open to Accrual: 04/05/2007
~Protocol Closed to Accrual: 11/23/2010
~Recruitment Location is the medical clinic"|
753653|NCT00470418||5 subjects did not meet entry criteria and were not baselined
753654|NCT00470392|Subjects were recruited from the Dermatology clinics at University Hospitals Case Medical Center and the Louis Stokes Cleveland VAMC.|Subjects with moderate to severe psoriasis were recruited from May 2007 to July 2012. 23 subjects were screened but only 9 were assigned to a study arm and received treatment. Per protocol, subjects underwent a washout period of 1 week for topical treatments and 1 month for systemic treatments prior to pre-treatment with Imiquimod or Clobetasol.
753655|NCT00470366|Protocol Open to Accrual 03/27/2007 Protocol Closed to Accrual 8/13/2013 Primary Completion Date 06-13-2016 Recruitment Location is the medical clinic|
753656|NCT00470301||
753657|NCT00470275||
753658|NCT00470262||
753659|NCT00470184||
753660|NCT00470158|All 6-18 month old permanent residents of selected villages near Kumudini Hospital were enrolled from May 8, 2007-August 31, 2007.|If one family had two eligible children, one was randomly selected for enrollment. Children with severe malnutrition (weight for height z-score -3 s.d.), severe anemia (hemoglobin <70 g/l), chronic illnesses that would impair feeding ability, planned move during the study period, or active fever (>38.5 C) were excluded from the study.
753661|NCT00470106|Participants were recruited from outpatient clinics at VA Greater Los Angeles Health care system and local mental health facilities. All patients met Diagnostic and Statistical Manual-IV criteria for schizophrenia, schizoaffective disorder, delusional disorder, or psychosis not otherwise specified (not secondary to substance use disorder)|This is not a drug study so there is no wash out or run in. Participants were excluded if they did not meet diagnostic criteria.
753662|NCT00470093||One participant was a screen failure.
753663|NCT00470067||
753664|NCT00470054|Between July 2007 and December 2008, 45 participants were recruited.|One(1) participant cancelled before receiving any protocol related therapy and 1 participant was deemed ineligible. All participants receiving treatment were analyzed for adverse events and only eligible (43) participants were analyzed for al other endpoints.
753665|NCT00469911||
753666|NCT00469898|Recruitment Period = 2/18/2004 through 1/23/2007|A total of 54 people signed consent to take part in the study. Of those, 3 were found to be ineligible and 1 withdrew before beginning the study.
753667|NCT00469859||
753668|NCT00469833|Recruited from VAMC from 2010-2012|No subjects excluded
753669|NCT00469612|Two subjects were recruited when study began, but before data were collected the study was terminated due to lack of resources.|
753670|NCT00469508|Study participants were 71 MA-dependent outpatients seeking treatment in the Los Angeles area recruitment from 4/07-9/08. Potential study participants were recruited from the community using advertisements for a study of experimental medications for MA dependence.|Subjects completed medical and psychiatric screening (to exclude any non-drug related Axis I disorder) and baseline assessments over a two-week/six-visit lead in.
753900|NCT00457197||
753901|NCT00457015||Patients were screened in advance of presenting with an HAE attack but were randomized only upon attack.
753671|NCT00469456|The recruitment period was from May 24, 2007 to July 29, 2008 at 25 centers in three countries [14 in Australia, 3 in New Zealand, 8 in South Africa].|Study consisted of up to 2 weeks single-blind placebo treatment followed by 12 weeks double-blind treatment. At end of single-blind placebo treatment, patients (pts) meeting entry criteria were randomized (1:1) to 1 of 2 double-blind treatment groups receiving memantine or placebo. Pts not meeting inclusion/exclusion criteria were not randomized.
753672|NCT00469391||
753673|NCT00469274|Between May 2007 and October 2009, all HCWs working at a 206-bed, tertiary care pediatric acute care hospital were recruited for enrollment. Inclusion criteria were age 18 - 64 years; self-report of direct patient contact; planning to work at least one year from enrollment; and willing to cooperate with surveillance.|Subjects were excluded from randomization if they had a previous pertussis exposure within the past 4 weeks; fever, cough, sore throat, or rhinorrhea; received PEP outside of the study; had been vaccinated with Tdap <7 days prior to the exposure; or were recognized as exposed ≥5 days after identification of the infected patient.
753674|NCT00469209|Recruitment period June 2006 to December 2008. All participants recruited at UT MD Anderson Cancer Center.|
753675|NCT00469092|Subjects were enrolled 64 sites in 15 countries in Africa, Europe, Asia, North America and South America.|A screening period of 1-2 weeks was followed by a run-in period of 4 weeks during which metformin was titrated to maximum 2550 mg and glimepiride to 4 mg, at the discretion of the investigator. Subjects who were already taking 4, 6 or 8 mg glimepiride continued on this dose. Doses were kept constant during the last week prior to randomisation.
753676|NCT00469079|Healthy smokers were recruited from the Twin Cities, MN metro area from November of 2006 through October of 2008.|
753677|NCT00468910|The study opened to accrual 02/22/2007 and closed to accrual 08/10/2009. Subjects were recruited at Northwestern University and University of Chicago.|A total of 110 subjects met the clinical definition of high risk for colorectal cancer, were entered onto the trial, and underwent initial spectral analysis. Of these, 81 had a cancer-associated spectral signature in histologically normal colonic mucosa.79 of these 81 subjects were randomized and began the study intervention
753678|NCT00468858||
753679|NCT00468845||
753680|NCT00468819||
753681|NCT00468728|Subjects were enrolled from April 2007 to November 2009 by centers in the United States, Canada, France, Spain, Belgium, Germany, United Kingdom, Italy, and Sweden.|
753682|NCT00468676|Participants were recruited from may 2007 to october 2009 from 14 primary care clinics of Group Health Cooperative in Washington State|Exclusion criteria: terminal illness, residence in long-term care facility, bipolar/schizophrenia, mental confusion suggesting dementia, pregnancy/breast-feeding, use of antipsychotic/mood stabilizer med, severe hearing loss, planned bariatric surgery within 3 months, ongoing psychiatric care
753683|NCT00468650||Eligible subjects had to have at least 2 attempts at sexual intercourse during the 2 week screening phase to begin the sildenafil citrate 50mg treatment at baseline.
753684|NCT00468585||
753685|NCT00468559|Participants aged 1 to 11 months inclusive with a clinical diagnosis of suspected Gastroesophageal Reflux Disease (GERD), symptomatic GERD, or endoscopically proven GERD were enrolled across the USA France Germany and Poland. All patients were symptomatic at study entry.|All participants received 2-weeks open label esomeprazole (Open-label phase) according to baseline weight (3 to 5kg: 2.5mg; >5 to 7.5kg:5mg; >7.5-12kg:10mg). Following the open-label phase, those with symptom improvement of at least one category in the physician global assessment were eligible to be randomized into the withdrawal phase.
753686|NCT00468546|A total of 520 participants were enrolled in the study conducted from 02 May 2003 and 12 July 2012 in 11 countries.|Of the total randomized 520 participants who met the eligibility criteria, four did not receive the study treatment and were not included in any analysis population.
753687|NCT00468481||572 subjects screened; 187 subjects screen failed; 385 subjects randomized
753688|NCT00468312||
753689|NCT00468299||
753690|NCT00468286||
753691|NCT00468208|Recruitment began in February 2008 and the final subject was enrolled in June 2010. Subjects were recruited through the clinical practices of each site investigator.|At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then signed the informed consent form.
753692|NCT00468169||
753693|NCT00468143|Men or women, aged 18 to 55 years, who met the DSM-IV criteria for ADHD, as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) version 1.2, were eligible to participate. Participants were recruited from local advertising or from the pool of participants at the MHADRP at NYU School of Medicine and VA NY Harbor Healthcare System.|Individuals who were currently receiving amphetamine or methylphenidate treatment underwent a 7-day washout period before the baseline visit; those receiving atomoxetine or other medications for ADHD were required to undergo a 28-day washout period before the baseline visit. While 62 subjects started the study, only 49 finished the full study.
753694|NCT00468104|Patients with loculated pleural effusions that failed to respond to chest tube placement and standard medical treatment and were considered for surgery were given the option to enter into a double blind cross over trial|108 patients were evaluated but only 100 entered the trial. 2 patients refused, 2 patients admitting physicians opted out of the trial, 3 patients chest tube removed inadvertently, 1 patient for coagulopathy
753695|NCT00468052|Recruitment period April 2007 to June 2009.Children recruited from the practice of the same pediatric otolaryngologist at UH in Newark. The study was introduced to the parent/legal guardian during the preoperative visit. Consent was obtained on the morning of surgery by a member of the pediatric anesthesiology study team.|None as long as the subject fit the inclusion criteria
753696|NCT00467961||
753697|NCT00467896|Patients were enrolled across 12 U.S. centers.|Adults with symptomatic pulmonary arterial hypertension (PAH) who were using Ventavis (Iloprost) Inhalation Solution Delivered by I-Neb Utilizing Power Disc-6 (PD-6) were enrolled
753698|NCT00467870||Of 531 subjects who were enrolled, 524 subjects received study treatment (at least 1 injection). The 7 enrolled subjects who did not receive treatment (2 in Part A and 5 in Part C) were excluded from all analyses.
753699|NCT00467857|Patients were enrolled between April 2006 and February 2009 at 5 centers in the United States, Europe, Asia, and Latin America.|Of 300 patients assessed for eligibility, 7 were not allocated to treatment due to inclusion or exclusion criteria.
753700|NCT00467844||
753702|NCT00467818|Recruitment was difficult for this study due to multiple disruptions in the flow of the study due to issues with the IRB process. Additionally, there were periods of time when there was not a research coordinator to assist with recruitment and pt flow.|Participants were required to undergo diagnostic testing and intelligence testing prior to starting the study. Individuals who were unable to participate in these processes were not allowed to enter into the active phase of the study.
753703|NCT00467779||Study included following stages: Stage 1, Stage 1A, Stage 2, Stage 2A, and Stage 3. Different participants were recruited in each stage.
753704|NCT00467753|Recruitment for this study was ineffective resulting in only 5 patients recruited, and 0 completers.|
753705|NCT00467740||
753706|NCT00467649||
753707|NCT00467610|Between 5/2007 and 10/2008, 6 patients were enrolled on trial and were treated at Rush university medical center.|
753708|NCT00467597||
753709|NCT00467584|Participants with Multiple Sclerosis were recruited from three Mayo Clinic sites (Arizona, Minnesota and Florida) beginning in July, 2007.|
753710|NCT00467558||
753711|NCT00467519|Participants were enrolled from 13 April 2007 to 16 October 2009 in 42 clinical centers in the US and 1 clinical center in Canada.|A total of 1042 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
753712|NCT00467389||
753713|NCT00467363|Study participants were recruited using community-based advertisements and physician referral to four university medical centres in the US (2006-12).|Out of the 1397 women with confirmed eligibility, consented, and expressed initial interest in the study, 60 (4.3%) chose to discontinue the enrolment process. An additional 109 (7.8%) tested positive for pregnancy at the baseline visit or became pregnant before their randomisation visit.
753714|NCT00467350|A convenience sample of patients aged 1 to 17 years was recruited between December 2006 and May 2009 from a pediatric emergency department.|There were no significant events that occurred after enrollment and before study arm assignment.
753715|NCT00467298||
753716|NCT00467285|Endo-Research clinic|Young male veterans with type 2 diabetes with creatinine less than 1.4, aged less than 55 years
753717|NCT00467259|Screening began 14 May 2007|Randomized 1127 women not using concomitant estrogen & progestin (E&P) therapy. An additional 134 women using concomitant estrogen & progestin therapy were randomized. Subjects were stratified by using or not using E&P by site and then randomized 4:1 300 mcg/d TTS or placebo.
753718|NCT00467077||
753719|NCT00467051||
753720|NCT00467038||
753721|NCT00466960||
753722|NCT00466947|Analysis on the primary outcome was performed when at least 535 first bacterial CAP episodes were reported from 2 weeks after vaccine Dose 3 (31 August 2010) with 23738 subjects (11875 and 11863 in Synflorix and Control groups) and analysis at study end was performed on 23597 subjects.|
753723|NCT00466921|The study opened February 24, 2004 to accrual with the first patient being treated on study April 19 2005. the study closed to further accrual February 7, 2011 after the last patient initiated study treatment.|
753724|NCT00466817||All 109 subjects started on valganciclovir. At the end of 6 weeks, subjects were randomized to valganciclovir or placebo. of the 109 subject that started, 12 dropped out before randomization and 1 subject was randomized but never received any blinded study drug.
753725|NCT00466752|Subjects were screened and enrolled at a single site in Seattle, Washington, United States.|Five subjects were screened for this study, deemed eligible and enrolled.
753726|NCT00466726||
753727|NCT00466687|This study remained open from 09/15/2004 to 1/27/2006.|36 patients consented to be in the study, two were determined not eligible.
753728|NCT00466661|Recruitment by clinical referral|Two week lead-in (Screening, Baseline)
753729|NCT00466505|Study recruitment period was May 2005 through January 2007.|A total of 18 people signed consent to participate in this study. One was determined ineligible, for a total of 17 patients on study.
753730|NCT00466440||
753731|NCT00466323||We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.
753732|NCT00466310|"Unmedicated patients treated for a first psychotic episode (n = 20), and patients treated for psychotic relapse of schizophrenia or schizoaffective disorder(n = 20).
~Controls who had no personal history of psychotic illness or relatives with psychotic illnesses,(n = 31). Individuals receiving treatment for diabetes or hyperlipidemia were excluded."|
753733|NCT00466206|Physician- or self-referral to the Chest Wall Deformity Clinic at UCSF for evaluation of pectus excavatum. Active recruitment from 2007-2009 to accrue ten subjects.|
753734|NCT00466193||Seven hundred and three (703) subjects were screened. Three hundred (300) subjects were randomized, but 5 subjects never took drug.
753735|NCT00466167||
753736|NCT00465998||
753737|NCT00465985||
753738|NCT00465972|Subjects were recruited from an HIV clinic in the Department of Internal Medicine, Duke University Medical Center|"We initially planned to have 3 arms: placebo, temazepam, and doxepin. However, based on the rate of recruitment, we limited the study to 2 arms: placebo and temazepam.
~Screening was carried out which included medical, and psychiatric, and sleep assessments."
753739|NCT00465894||
753740|NCT00465816||During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected.
753741|NCT00465738|216 female and male subjects with upper limb spasticity caused by either stroke, brain injury, spinal cord injury, multiple sclerosis or cerebral palsy were screened starting February 2007. Recruitment advertisements according to local law and approved by the responsible IEC were published as needed.|The protocol contained a screening period of 7 days to allow evaluation of laboratory and ECGs in order to determine eligibility. 24 subjects were screening failures due to violation of selection or protocol criteria.
753742|NCT00465647|23-Apr-2007 (first subject, first visit) to 03-May-2009 (last subject, last visit). Multicenter study conducted at 18 sites in the United States (US).|Subjects who were anticipated to have acute, postoperative pain requiring oral opioid analgesics for at least 24 to 48 hours following postoperative parenteral analgesia.
753744|NCT00465569|Children between the ages of 6 and 21 years with a known history of IgE-mediated milk allergy were recruited from the pediatric allergy clinics at the Johns Hopkins University Hospital, Baltimore, Maryland, and Duke University Medical Center, Durham, North Carolina.|Eligibility criteria were a positive skin prick test (SPT) response to milk extract (wheal ≥ histamine control) or milk immunoglobulin E (IgE) level of > 0.35 kilounits per liter (kU/L) and a positive milk challenge result at baseline defined as reacting with clear signs, symptoms, or both to a cumulative dose of 2.5 g or less of milk protein.
753745|NCT00465530||
753746|NCT00465361|Recruitment Period: August 2007-July 2008 Location: Academic medical center|Seven participants were enrolled. Four participants did not complete the study due to personal issues.
753747|NCT00465270||
753748|NCT00465179|All participants were enrolled between March 2007 and August 2010 at The University of Texas (UT) MD Anderson Cancer Center (MDACC).|61 participants were enrolled to the study. 4 participants did not receive any treatment, resulting in 57 participants available for evaluation.
753749|NCT00465101|This study enrolled patients at least 45 years of age with symptomatic/obstructive BPH for at least 3 months and requiring surgical intervention. Enrollment occurred at 10 academic and private medical centers in the US. The last patient follow up visit was completed in August 2012. The last site close-out visit was completed January 2013.|
753750|NCT00465088||Of the 199 subjects randomized, 6 did not receive study drug: 2 withdrew consent, 1 had a protocol violation, and 3 had randomization errors. 193 subjects were treated.
753751|NCT00464945|Participants were recruited in Poland from June 2007 to August 2007.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
753752|NCT00464815||The target sample size was 1024 enrolled subjects, but a total of 1025 subjects (in all age strata) were actually enrolled and vaccinated in seven study centres in India, Taiwan and the Philippines.
753753|NCT00464737|The Full Analysis Set (FAS) contains all randomized subjects who received at least 1 dose of trial medication, and had at least 1 post-Baseline Likert pain score. The Per Protocol Set contains all subjects in the FAS who completed at least 2 weeks of the Maintenance Phase and had no major protocol deviations.|Participant flow is based on the 230 randomized subjects however 1 subject randomized to Rotigotine 4 mg/24 hrs did not receive study medication and was excluded from the Safety Set. Thus 229 subjects are included in summaries of baseline characteristics and adverse events. The excluded subject was a 47-year old female enrolled in the United States
753754|NCT00464711||
753755|NCT00464698||
753756|NCT00464685||
753757|NCT00464672|Approximately 6 weeks for enrollment with date of first enrolment on April 2007|All enrolled subjects were included in the trial.
753758|NCT00464646||
753759|NCT00464620|50 patients with GIST were enrolled between June 2008 and December 2009 and 48 were evaluable for response. Between May 2007 and May 2009, 200 patients with advanced, high-grade sarcoma were enrolled into the aggressive subtype for this study. 116 patients were registered beginning in July 2007 to the indolent subtype for this study.|
753760|NCT00464568|A total of 32 healthy adult females and males aged 18 to 50 years and having a positive history of seasonal allergic rhinitis (SAR) were enrolled. The study was conducted at a single center in Germany from 28-March-2007 to 16-May-2007.|Participants who were positive for grass pollen on radioallergosorbent and skin prick testing were enrolled. Participants underwent Screening 7 to 28 days prior to study start.
753761|NCT00464542|Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. Two of these women were lost to follow-up within 2 weeks of enrollment. A third woman was lost to follow-up after initiating metronidazole therapy at study midpoint.|
753762|NCT00464490|Total accrual reached 42 of the planned 60; unanticipated common usage of Dexmedetomidine led to difficulty recruiting intubated/sedated patients who had not used it within protocol-specified period prior to enrollment. Also, some providers were not willing to allow patient assignment to the control arm given the popular usage of the drug.|
753763|NCT00464464||
753764|NCT00464438||
753765|NCT00464334|Participants were recruited from 51 sites in Europe, South America and the United States. The primary treatment period was from June 2007 to August 2010, with follow up through January 2012.|
753766|NCT00464308||
753767|NCT00464269|This study started to enroll subjects in September 2007 and concluded in January 2009. 400 subjects were randomized of which 396 are included in the Safety Population.|Participant Flow refers to the Randomized Set (RS).
753768|NCT00464204|Participants were recruited in 24 intensive care units of hospitals in France and Germany from July 2007 until February 2010 and were followed up until May 2010.|Participants were screened in intensive care units of the participating study sites in France and Germany.
753769|NCT00464087||Patients who were enrolled and received fondaparinux and who did not have sufficient disease requiring any revascularization procedure will be followed through the duration of the hospitalization. Patients will have a complete blood count (CBC) prior to discharge. These patients are enrolled, but considered screen failures.
753770|NCT00463866|This was a 6-month, randomised, open label, parallel-group, active controlled, multinational study, in participants with uncontrolled/partly controlled asthma, who were symptomatic despite daily use of inhaled glucocorticosteroid (IGCS) with or without Long-Acting β2 agonist (LABA).|
753771|NCT00463840|Total 24 patients were enrolled to this Ph I/II study between June 2004 and December 2009 at New York University Medical Center.|The efficacy and toxicity data were based on both Ph I and II.
753772|NCT00463801||
753773|NCT00463788||Following a mandate of the Spanish health authority, data from all participants at site 0904 (Spain) were excluded from analyses due to evidence of misconduct, with significant deviations from Good Clinical Practice guidelines. Therefore, 173 of the 181 randomized participants were considered in the full analysis set (FAS).
753774|NCT00463684|Potential subject children were identified through Ministry of Health (MOH) birth and immunization registries of selected vaccination clinics.|
753775|NCT00463606|760 participants were randomized at 144 sites in the United States, and 758 participants were treated between 07 June 2007 and 10 February 2008. Two participants were randomized but not treated: 1 was lost to follow-up and 1 was withdrawn at the investigator's discretion.|A total of 168 study sites screened participants, wtih 144 of these sites randomizing participants.
753776|NCT00463580|Participants were enrolled at Emory University in Atlanta, Georgia. Enrollment began in December 2008 and all participation ended in June 2011.|Group assignment was stratified based on sex and screening values of C-reactive protein (CRP) concentration (less than 2mg/L or 2mg/L and greater).
753777|NCT00463567||This study consisted of two stages: a dose selection stage (Stage 1, 2 weeks) from which 2 out of 4 Indacaterol doses were selected following interim analysis to continue into Stage 2 for comparisons of efficacy, safety, and tolerability for total treatment of up to 26 weeks.
753778|NCT00463476|Healthy children 2 and 5 years of age who had previously received two and three doses of inactivated mouse brain-derived vaccine (IMBV), respectively, were enrolled in the Colombo District of Sri Lanka between July and October 2007.|
753779|NCT00463437||
753780|NCT00463385||
753781|NCT00463346||
753782|NCT00463229||
753783|NCT00463060|Recruitment period began January 2007 and was open for recruitment through July 2014 with 47 patients enrolled in the study between February 2007 and September 2010.|"One patient withdrew prior to starting treatment and was excluded from analysis.
~Phase 1: 21 patients in Phase 1 in dose-escalating study to find maximum-tolerated dose Phase 2: 25 patients on the recommended phase II dose, 37.5mg"
753784|NCT00463047|Subjects 18 to 80 years of age with chronic pain for at least 3 months, were opioid tolerant, on around-the-clock opioid therapy, with 1-4 breakthrough pain episodes a day were recruited from 46 centers in the United States. First participant screened: June 2007. Last participant last visit: February 2009.|"Prior to the double-blind treatment period, subjects participated in two titration periods to identify a successful and tolerated dose of Fentanyl Buccal Tablets (FBT) and immediate-release oxycodone. Subjects who did not titrate successfully were excluded from further participation in the study."
753785|NCT00462982||
753786|NCT00462943||
753787|NCT00462917||
753788|NCT00462904||
753789|NCT00462865|18 women enrolled from 3 hospitals, 17 treated|
753790|NCT00462839|The study was conducted on two separate dates at Prentice Women's Hospital. Eight stations were set up in 8-12 hour periods in an empty labor and delivery room. Participants were randomized in blocks by provider type. The order of the volumes was randomized. Subjects were not informed that the volumes in the two groups were the same.|
753791|NCT00462826|Patients were accrued to the first stage of accrual from 11/5/2007 to 6/2/2008. Patients were accrued to the second stage between 4/6/2009 and 7/13/2009. They received 4 mg/kg IV of VEGF-Trap every two weeks. One cycle was 28 days.|Patients were required to have had one prior chemotherapeutic regimen for the treatment of endometrial carcinoma. Patients entering the study therefore were required to have either persistent or recurrent cancer that was measurable by RECIST.
753792|NCT00462761|A total of 76 participants who met all inclusion and no exclusion criteria were enrolled and treated in the study at 4 clinical sites in the United States and 2 sites in the Republic of Georgia.|
753793|NCT00462748|"Patients with diabetes, cardiovascular disease (CVD) or a high risk of developing CVD and a fasting LDL-C level of ≥2mmol/l, having been on simvastatin 40mg for 6 weeks were assigned to 10/40 mg ezetimibe/simvastatin; 40 mg atorvastatin; 10 mg rosuvastatin (5 mg in elderly/Asian patients (in line with UK SPC)) between 27/03/2007 and 31/03/2008"|All patients were subjected to a 6 week run-in period on open label 40 mg simvastatin to stabilise their LDL-C levels. Patients whose LDL-C at the end of this period was below 2.0 mmol/l or who were <75% compliant with run-in medication, were excluded from the study
753794|NCT00462735|Recruitment period January 2007 through April 2008. All cases were reviewed at a multidisciplinary conference, which was attended by representatives from the Departments of Head and Neck Surgery, Radiation Oncology, Medical Oncology, Palliative Care, Social Work, and Nutrition at Icahn School of Medicine at Mount Sinai.|
753795|NCT00462722||
753796|NCT00462709||
753797|NCT00462670||
753798|NCT00462644|Adult trauma patients admitted to Erlanger Health System's Level I trauma center requiring rapid sequence induction were randomized to one of two approved drug treatment regimens.|72 hour waiver of consent granted by the Institutional Review Board (IRB)
753799|NCT00462605||
753800|NCT00462501||
753801|NCT00462488||
753802|NCT00462462||32 patients were enrolled in the study, but 31 received the study product (1 patient not treated; inclusion mistake).
753803|NCT00462449|Recruitment period from 11/15/2007 through 10/05/2009. Subjects were recruited primarily from the PI's clinical patient pool with unilateral, upper extremity spasticity. All subjects were required to be at least 6 months post insult.|
753804|NCT00462423||
753805|NCT00462384||
753806|NCT00462345||
753807|NCT00462332||
753808|NCT00462306|We compared Berlin Questionnaire scores between pregnant and nonpregnant females between October 2005 through September 2007. The study group consisted of pregnant women presenting to Prentice Women's Hospital and non-pregnant females (control group) presenting to Northwestern Memorial Hospital for ambulatory surgery.|An anesthesia team member used a standard verbal consent script to obtain verbal consent for study participation. 4074 parturients and 503 non-pregnant women completed the Berlin Questionnaire. 13 of the non-pregnant patient questionnaires were excluded due to insufficient data.
753809|NCT00462280||
753810|NCT00462228|Subjects were recruited by contacting patients of the principal investigator (PI) when they presented for regularly scheduled clinic appointments or by referrals from colleagues. The recruitment period was from was from July 2007 through December 2010.|
753811|NCT00462124||
753812|NCT00462072|A total of 31 subjects were enrolled from our clinic between April 4th, 2007 and June 8th, 2009.|Subjects were enrolled based on protocol inclusion / exclusion criteria. Subjects were required to be starting Infliximab as a requirement for entry into the study.
753813|NCT00462020|All patients with perforated appendicitis were recruited for this study.|
753814|NCT00461981|A total of 101 subjects were entered and randomized into the study at 15 sites in the United States of America between 07 May 2007 and 28 Jun 2007.|
753815|NCT00461851|19 patients were screened, 17 enrolled in the study.|
753816|NCT00461812||33 participants were consented for this study. However, there were 23 pre-randomization screening failures. Only 10 were enrolled. The number of participants assigned/randomized to each Arm/Group is unknown.
753818|NCT00461734||"Partecipants initially assessed for eligibility were 248 of whom 8 were excluded before the randomization due to the following causes:
~4 failed inclusion/exclusion criteria
~2 cheanged medical condition resulting no longer eligible
~1 had a non-pacemaker procedure
~1 the site was aware of his/her randomization code in the envelope"
753819|NCT00461708||
753820|NCT00461682|This study was conducted from 26 January 2007 till 18 September 2007. A total of 21 participants with irritable bowel syndrome (IBS) were planned to be enrolled.|Due to difficulties with recruitment, only one participant was enrolled in the study; however the participant received only Placebo and not the study drug.
753821|NCT00461630|245 sites January 2007 to July 2010|Prior to randomization, each participant received simvastatin 40mg daily; if this dose was not as effective as their prior statin treatment or their total cholesterol was ≥135 mg/dl after 4 weeks on simvastatin alone, ezetimibe 10mg daily was added. Participants then received ERN/LRPT 1g/20mg daily for 4 weeks followed by 2g/40mg daily for 4 weeks.
753822|NCT00461591||
753823|NCT00461552||
753824|NCT00461513||
753825|NCT00461500||
753826|NCT00461331|Patients with Type I diabetes mellitus using an insulin pump were recruited from the outpatient clinics.|There was no run -in or transition before starting the test period. However, there was a wash out period of up to 2 weeks between the 2 test periods.
753827|NCT00461305||Full Analysis Set (FAS) consisted of all patients randomized who received at least one dose of study drug. Patients were analyzed as treated. FAS was the primary analysis set for the efficacy and safety. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS without major protocol deviations reported by Cycle 6.
753828|NCT00461292||
753829|NCT00461253||
753830|NCT00461175|Overall, 63,194 patients were recruited for the EURAS-IUD study, and 1,746 patients were excluded due to protocol violations. Of these, information on the IUD inserted at baseline is missing for 859 women. Therefore, 859 recruited patients could not be assigned to one of the cohorts and are not counted in the table displaying the participant flow.|
753831|NCT00461123|Enrollment started on 19 March 2007 and the last study visit occurred on 02 June 2008. The study was conducted at one center, a university clinic in Germany.|Number of subjects enrolled, randomized and exposed to at least one dose (safety population): 50. Number of subjects who had undergone surgery, whose type of surgery (Greenlight(TM) laser-ablation) had not changed, energy consumption during surgery reported and who had taken the second dose on the day of surgery (intent-to-treat population): 44
753832|NCT00461097|Recruitment took place at five university-based medical centers in the United States (Mt. Sinai School of Medicine, Johns Hopkins University, Duke University, National Jewish Medical Center, University of Arkansas Children's Hospital) from July 2007 to December 2008.|
753833|NCT00461045||
753834|NCT00461032|"Participants were randomized at 165 sites in the US and Canada.
~Therapy period: June to November 2006 (including screening period)."|Participants who were hospitalized for asthma in the 4 weeks prior to randomization or who required excluded medications were excluded from randomization.
753835|NCT00460993||
753836|NCT00460811|Patient recruitment occurred over a 12 month period from March 2007 to February 2008 at 92 US study sites.|Patients went through a 14 to 17 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS).
753837|NCT00460798||A total of 448 subjects were enrolled. Subjects were eligible for treatment analysis if complete dosing data were available. Of the total 448 subjects enrolled, 421 were eligible for treatment analysis and were recorded as treated. Three subjects who were included in analysis had missing demographic data.
753838|NCT00460746||
753839|NCT00460655||
753840|NCT00460603||
753841|NCT00460577||
753842|NCT00460564||
753843|NCT00460551||
753844|NCT00460525|Subjects were recruited from the population of healthy children aged 1-6 years residing in the town of Bandiagara.|
753845|NCT00460434|All women presenting to the participating PFDN clinical centers with the complaint of prolapse, as defined by the inclusion criteria, will be screened for the subjective complaint of SUI using items on the PFDI. Eligible individuals will be offered RCT participation.|Participants consisted of women who were being considered for an apical and/or anterior vaginal prolapse repair via a vaginal approach without subjective complaints of SUI. They must have had vaginal bulge symptoms (defined as positive responses to the PFDI), and anterior vaginal prolapse with point Aa at -1cm or greater (determined by POP-Q).
753846|NCT00460421|This phase 1 dose-escalation study to evaluate the safety and pharmacokinetics (PK) of palifermin in pediatric subjects with acute leukemias undergoing myeloblative therapy and allogeneic hematopoietic stem cell transplant (HSCT) was performed in 7 centers in USA between 2006 and 2011.|
753847|NCT00460408||
753848|NCT00460265|Subjects were enrolled from 25 May 2007 to 10 March 2009.|
753849|NCT00460239||
753850|NCT00460109||
753851|NCT00460031|Thirty seven (37) patients were screened from Cleveland Clinic and University Hospitals in the Cleveland area from February 2007 to April 2009.Three patients were not eligible.|
753852|NCT00459979||
753853|NCT00459953||The enrollment number in the protocol section (141) differs from the number of participants started in the participant flow module (143) because 2 of those originally enrolled were discovered to be living in the same household and assigned to different treatments. Thus, they were excluded from analyses.
753854|NCT00459875||
753855|NCT00459862|Thirty-four participants were accrued between May 2007 and October 2008.|All 34 participants were evaluable for the primary endpoint.
753856|NCT00459810|Twenty-one patients enrolled in the trial between March 2007 and May 2008 in the medical clinics at Oregon Health & Science University and the University of California at San Francisco.|
753857|NCT00459732|Subjects were recruited from 3 hematology clinics in the US between April, 2006 and May, 2008. 114 potentially eligible patients were screened, 43 were considered eligible and consented to participation.|Following enrollment, prior to group assignment, subjects were screened for copper and vitamin D status. If serum copper was <70ug/dL and/or 25OH vitamin D <20ng/mL, they were placed on daily supplementation, 2 mg Cu/day and/or 1000 IU vitamin D/day.
753858|NCT00459706||
753859|NCT00459667|Eligible patients for this study included only those who completed the preceding BEYOND study. Patients were enrolled at the conclusion of the preceding study from 03 May 2007 until 14 March 2008. Patients who interrupted study medication in accordance with the investigator were eligible, provided it did not result in premature End of Study.|All enrolled patients who had been randomized during the predecessor study to IFNB 1b (Interferon 1b) continued on previously double-blinded medication in the BEYOND-FU study; all patients who had been previously randomized to Copaxone and all patients with premature end of study medication received open-label IFNB 1b 250 µg (IFNB 1b 250 µg*).
753860|NCT00459537||
753861|NCT00459381|Subjects accrued between June 2007 to January 2008 at 4 NABTC Cancer Centers using their outpatient facilities. Survival follow-up extended to June 2009|
753862|NCT00459368|Health system primary care providers (i.e., in the areas of family practice, internal medicine, and pediatrics) were invited to participate. Physicians who consented to participate were grouped according to practice.|One hundred ninety-two (92%) of the 207 primary care staff clinicians, representing 34 pre-defined primary care practices within the health system, agreed to participate. One clinic was not included a priori since it functioned as the primary resident clinic for internal medicine trainees.
753863|NCT00459355||
753864|NCT00459342|Recruitment Period: March 22, 2007 to April 20, 2009. All recruitment done at UT MD Anderson Cancer Center.|
753865|NCT00459316||
753866|NCT00459303|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye. All cases were enrolled from October 2005 to April 2006 and were followed up for at least three months at the department of ophthalmology.|Patients with diabetes or other systemic disease, such as dysthyroid related orbitopathy or drug related optic neuropathy, that may potentially affect contrast sensitivity and visual quality were excluded.
753867|NCT00459290|The study was activated on 5/7/2007 and closed to accrual on 10/29/2007.|
753868|NCT00459186|Patients were recruited from the Genitourinary Oncology clinics of Dana-Farber Cancer Institute and the Knight Cancer Institute at Oregon Health and Science University between November, 2005 and October, 2008|
753869|NCT00459134||
753870|NCT00459121|Unable to enroll patients in a timely fashion. The decision was made to close the study after consulting with AstraZeneca.|Feasibility and safety.
753871|NCT00459108||
753872|NCT00459056|patients were recruited from medical clinics|Patients using anti-hypertensive medication(s) at baseline were allowed to undergo a 1-month washout prior to randomization.
753873|NCT00459043|From March 2007 to October 2009, 30 patients were enrolled from four different sites in United States.|Patients were randomized in a 1:1 ratio to receive docetaxel alone or docetaxel and vandetanib as combination therapy. No stratification at randomization was made for the study
753874|NCT00458952|24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in the trial at 3 US sites. 21 patients received Ultratrace Iobenguane I 131 while 3 patients failed to meet all inclusion/exclusion criteria and were therefore not dosed.|Planned Doses: 6, 7, 8 & 9 mCi/kg. Dose reductions in 7, 8 & 9 mCi/kg cohorts were made so total activity administered to pts would not greatly exceed allowed total activity of 525, 600, & 675 mCi for these groups, respectively. Thus, pts were subsequently analyzed in 2 groups of ≤500 mCi and >500mCi, consisting of 7 & 14 patients, respectively.
753875|NCT00458848||We are reporting on the subset of patients that was treated according to amendment three, in which Imatinib was given only at induction.
753876|NCT00458822||
753877|NCT00458705||
753878|NCT00458536||
753879|NCT00458484|Participants were recruited local hospital from 2/2007 to 5/2017.|
753880|NCT00458406|N=60 families were enrolled; N=4 of these were excluded due to various medical conditions. Of the remaining N=56, N=43 were enrolled into the Bi-Flex arm and N=13 were enrolled into the CPAP arm.|Sixty-nine consecutive families were approached for the study. Nine families declined the study. N=60 families were enrolled; N=4 of these were excluded due to various medical conditions. Of the remaining N=56, N=43 were enrolled into the Bi-Flex arm and N=13 were enrolled into the CPAP arm.
753881|NCT00458393|The study recruited HIV uninfected participants whose sexual practices put them at risk for HIV infection. They were recruited from community clinics.|
753882|NCT00458341||Participants were randomized so that half received the lower-dose level in Cycle 1 and then the higher-dose level in Cycle 2 (low-to-high dose sequence) and half received the higher-dose level in Cycle 1 and then the lower-dose level in Cycle 2 (high-to-low dose sequence).
753883|NCT00458302|xxxxx|
753884|NCT00458237|Patients enrolled from July 2007 through May 2009.|
753885|NCT00458211|40 subjects from three State Hospitals were recruited and participated between 2005 and 2008: four in-patients from Rochester Psychiatric Center, 17 out-patients from Buffalo Psychiatric Center and 19 in-patients from Bronx Psychiatric Center|
753886|NCT00457977|Participant's were recruited from 10 medical centers across the US from April 9, 2007 to May 7, 2009.|
753887|NCT00457951||
753888|NCT00457821|Part 1 started on 10 May 2007 (signing of first informed consent). After obtaining consent, Part 1 screening evaluations were completed during Day -28 to Day -2. Part 2 started on 28 May 2008 (signing of first informed consent). Part 2 screening evaluations were also completed during Day -28 to Day -2 before the first dose of study drug.|In Part 1, 21 subjects were randomized but 1 subject was excluded prior to dosing because the subject needed a protocol-prohibited medication. In Part 2, 20 subjects were randomized but 1 subject withdrew consent to the study prior to dosing.
753889|NCT00457795||
753890|NCT00457743||Phase 1 only included Cycle 1 for subjects enrolled in Phase 1. Phase 2 was comprised of either Cycle 2 and beyond for subjects who were enrolled in Phase 1, or all cycles for newly enrolled subjects. Additional subjects were enrolled to make a total of 30 in the recommended dose level (50-mg).
753891|NCT00457730||
753892|NCT00457691||
753893|NCT00457665||
753894|NCT00457639|Recruitment December 2006 through April 2010. A total of 37 subjects were screened for this trial.|
753895|NCT00457418||
753896|NCT00457392||
753897|NCT00457366||
754649|NCT00418028|Between November 2004 and August 2010, 195 patients were randomly assigned to Cint (97) and Ccont (98) in 13 GEICAM sites in Spain.|
753902|NCT00457002|First patient, first visit was June 2007 and last patient, last visit was May 2011. Acutely ill patients who had been hospitalized and had an expected hospitalization of an additional 3 or more days after randomization were enrolled.|6758 enrolled; 6528 randomized to treatment. Reasons for non-randomization: 2 Adverse event (AE); 34 withdrew consent; 1 death; 3 poor/non-compliance; 162 no longer met study criteria; 2 administrative reason by Sponsor; 26 other reasons.
753903|NCT00456989||
753904|NCT00456885|Flyers, Craig's list, posters used for recruitment.Recruitment occurred between 2007 and 2010. After telephone screen subjects were evaluated at the BIDMC clinical research center.|
753905|NCT00456846||
753906|NCT00456807|Subjects enrolled at pre-selected sites in the primary study HPV-015 (NCT00294047) who were in the immunogenicity subset and have received all three doses of vaccine/control were asked to participate in the present ancillary study.|This ancillary study will consist of supplemental testing of serological and cervical samples obtained at Visit 5 (Month 12) and Visit 6 (Month 18) of the primary study HPV-015 (NCT00294047) from pre-selected sites.
753907|NCT00456755|Recruitment started at Jan 2004. Patients were recruited as volunteers from the Prince of Wales hospital, the Yan Chai hospital and the Alice Ho Mui Ling Nethersole Hospital specialist clinics.|Confirmed perennial allergic rhinitis and have a positive skin test to house-dust mite, mold antigens and/or animal dander was required. Enter 1-week run-in-period, during which symptom diary was given to each subject for the evaluation of symptoms. Eligible case with total score higher than 4.
753908|NCT00456625||
753909|NCT00456612||
753910|NCT00456599||
753911|NCT00456547||
753912|NCT00456521||
753913|NCT00456508||
753914|NCT00456495|Five consecutive subjects were enrolled over an 18-month period in a single ophthalmic oncology center.|There was a single ARM in this study. Subconjunctival 0.5 mg ranibizumab was given as intervention every 2-4 weeks.
753915|NCT00456365||
753916|NCT00456300|11 subjects were enrolled into the study. Of these, 9 subjects were randomized and only 8 subjects completed this three part study. These subjects were recruited from the diabetes clinics.|Two subjects failed screening and could not be randomized to particiapate.
753917|NCT00456261||
753918|NCT00456092|Participants were enrolled across 38 sites in Canada, Belgium, Germany, the Netherlands, and the United Kingdom.|Participants were randomized 1:1:1 to either apremilast 40 mg once daily, 20 mg twice daily, or placebo. On Day 85 participants originally randomized to placebo were re-randomized to receive apremilast; participants randomized to apremilast continued on the same dose regimen. Randomization was stratified based on methotrexate use at baseline.
753919|NCT00456014|From September 2006 to May 2012, participants were recruited through online or print advertisements, and through referrals from neighboring outpatient clinics.|MDD subjects who were currently on ineffective medication trial only enrolled if they were able to tolerate a medication washout.
753920|NCT00455975||
753921|NCT00455962||
753922|NCT00455923|This study was conducted at a single center with two sites in Sweden from May 2005 to July 2007. Seretide Diskus®, Flixotide® and Ventoline Diskus® are the registered products of GlaxoSmithKline.|
753923|NCT00455858|A total of eight study sites in South Korea.|Between screening and treatment with study drug, subjects were assessed for eligibility. After start of treatment, all subjects were to have their dosage titrated individually based on SMPG (self-monitored plasma glucose) values during the 20-week titration and treatment period to reach and maintain pre-breakfast SMPG below 6.0 mmol/L (108 mg/dL).
753924|NCT00455741|36 subjects consented; 6 failed screening, 2 decided not to participate.|1 subject terminated during study (hemoglobin drop) for a total of 24 completed.
753925|NCT00455702|Participants were stable adult outpatients at an urban community mental health center, ages 18-65 years, with a diagnosis of schizophrenia .|
753926|NCT00455689||
753927|NCT00455663|Subjects were outpatients recruited in 2 streams. Ninety-nine were recruited at the time of discharge from an inpatient psychiatric facility and followed for 3 months after discharge prior to baseline assessments and randomization|Of the 99 recruited at hospital Discharge:11 rehospitalized,9 not located,8 withdrew consent,4 incarcerated,3 unable to complete assessments,2 aggressive behavior,2 medication,1 deceased Of 57 outpatient recruits;4 withdrew consent,1 unable to complete assessments,1 medication, 1 unsafe,1 aggression, 1 substance abuse, 1 deceased, 1 moved
753928|NCT00455650|Participants were stable, outpatient, non-smokers with schizophrenia on a stable dose of antipsychotic medication for at least 4 wks, from an urban community mental health clinic in Boston. Controls were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID|89 participants were enrolled, 71 participants (30 patients, 41 controls) completed at least one medication visit and were included in the analyses. 4 participants (3 with schizophrenia, 1 control) missed one and 5 participants (3 with schizophrenia, 2 controls) missed 2 of the 3 medication visits.
753929|NCT00455533||A total of 384 participants were enrolled in this study; 71 did not receive any study medication.
753930|NCT00455520|The recruitment period for this out-patient, multicenter study occurred between 15 March 2007 and 20 August 2008.|The study consisted of a 2-week screening period followed by a 3-week open-label phase where all subjects received tapentadol extended release (ER) and were titrated to an optimal dose, and a 12-week double-blind phase where subjects were randomly assigned to receive tapentadol ER or placebo.
753931|NCT00455455|Participants recruited from local communities in Kitchener-Waterloo, Canada between May 2007 and Feb 2008.|64 participants recruited and screened; 14 withdrawn prior to the group assignment due to loss of interest, relocation and inconvenience.
753932|NCT00455429||
753933|NCT00455312||
753934|NCT00455195||81 of the 90 participants enrolled in the double-blind placebo controlled AGLU02704 (NCT00158600) study continued on to the open-label extension study AGLU03206.
753935|NCT00455143|Recruitment period from September 2006 to March 2008|
753977|NCT00452673|28 Jan 2007 to 30 Oct 2012. Women with advanced breast cancer (ABC) were enrolled.|57 enrolled and 52 treated. Reasons for not being treated: 4 no longer met criteria; 1 administrative reason by sponsor. Drug was administered at a reduced dose (gradually escalating at each dose level) during the escalation period and then once a dose for the expansion cohort was identified, additional participants were treated with this dose.
753936|NCT00455013|First 6 months (July 2007 to October 2008) assessed acute rejection of the renal transplant up to that time. All outcome measures were also assessed at 12 months post transplantation. Participants who wished to continue into the long term extension (LTE) signed a new consent form and were evaluated at 24, 36, and 48 Months post transplantation.|Epstein-Barr virus positive recipients of renal allograft from living or deceased donor. Excluded if panel reactive antibodies greater than, equal to (>=) 50 % or prior graft loss due to acute rejection. 93 participants randomized; 89 transplanted/treated: (1) fever on the day of surgery, (1) problem with allograft, and (2) withdrawal of consent.
753937|NCT00454987|Study participant flow also includes data from the booster phase (NCT00258700), as SAEs were collected on all the subjects enrolled in the booster phase, which included subjects enrolled in the current NCT00454987 study.|Only subjects from booster phase who volunteered to participate in the long term follow up at year 1,2&4 were enrolled at the respective years,leading to higher enrolled subjects at year 2 (386) compared to year 1 (288)
753938|NCT00454909|Out of the 873 subjects enrolled in the study, only 872 subjects received the vaccination course and started the study.|
753939|NCT00454857||
753940|NCT00454818||
753941|NCT00454805|Randomised=ITT=Safety: Cediranib 31, Placebo 31|In this study, 75 patients were enrolled and 62 randomised.
753942|NCT00454779|Subjects were enrolled from 29 January 2007 to 1 September 2010.|The planned number of subjects to enroll was 110. The actual number of subjects enrolled was 113.
753943|NCT00454649||A total of 102 participants were enrolled for the study. Out of those, 4 participants were screen failure and were not included in results analysis.
753944|NCT00454636||
753945|NCT00454584|903 partcipants received either ustekinumab (CNTO 1275) or etanercept at 67 sites in North America and Europe.|
753946|NCT00454571||
753947|NCT00454532||
753948|NCT00454363|Open recruitment period: March 2007 to December 2009. All recruitment done at University of Texas (UT) and Dana Farber Cancer Institute.|Of the 52 enrolled, one participant was excluded from the study prior to study treatment.
753949|NCT00454324||30 patients consented to participate in the study. 3 patients were consented but not treated; 2 were found ineligible, and 1 withdrew before treatment.
753950|NCT00454246||
753951|NCT00454207|Eight centers in Japan|Twenty-one pulmonary arterial hypertension patients who have never received sildenafil therapy entered the study from Part I period and could continue to study part II period. Twenty-three patients who were continuously using sildenafil entered the study from Part II period.
753952|NCT00454194|One-hundred and ten (110) participants were enrolled between October 2007 and April 2010.|Twelve participants were excluded from all analyses due to five participants had squamous-cell histology, 1 never received treatment and 1 withdrew consent in pemetrexed+sorafenib group; and three participants had squamous-cell histology and 2 never received treatment in pemetrexed alone group.
753953|NCT00454181|Enrollment took place between January 2007 and March 2009 at 10 university-affiliated dental clinics across the US.|All 59 enrolled subjects were randomized to treatment and took at least 1 dose of assigned study drug.
753954|NCT00454142|Subjects were screened and enrolled from 2 sites in Singapore, 27 were enrolled from National Cancer Centre Singapore and 6 were enrolled from National University Hospital.|Once a subject signed the informed consent form, the required screening procedures would be performed.Eligible subjects would undergo 2 times of DCE-CT scan before study drug administration.
753955|NCT00454116|First patient randomised 14 March 2007, last patient randomised 21 Jan 2008, data cut off data 31 March 2008|
753956|NCT00454051||
753957|NCT00453999||
753958|NCT00453986||"All subjects were included in 1 of the 2 cohorts:
~Flu vaccine cohort: in the 5 groups, subjects received Nimenrix vaccine (lots A, B or C) or Mencevax ACWY vaccine or Nimenrix lot A and Fluarix vaccines.
~Non-Flu vaccine cohort: in the 4 groups, subjects received Nimenrix vaccine (lots A, B or C) or Mencevax ACWY vaccine."
753959|NCT00453973||
753960|NCT00453921||
753961|NCT00453895|The first patient was included in the study on July 17, 2007, the last patient enrolled on September 18, 2009. The last patient stopped the study drug on November 20, 2009.|
753962|NCT00453479|From 29 March 2007 to 11 October 2007, total of 23 participants with chronic obstructive pulmonary disease (COPD) were randomized at four centres in the Netherlands. DISKUS™ is registered product of GlaxoSmithKline.|
753963|NCT00453388||
753964|NCT00453362|A single-arm, open-label, multicenter, international pilot study. The study was expected to enroll approximately 100 evaluable patients at approximately eight sites in Australia and the United States. The study was initiated on 6 DEC 2006 and completed on 23 APR 2010.|
753965|NCT00453349|A total of 463 females with uncomplicated PID were enrolled on the basis of a complete evaluation (interview, medical history and physical examination and laboratory tests). 460 subjects were randomized, 412 completed study treatment (whole medication), and 384 subjects were valid for the primary efficacy analysis.|The efficacy results in ITT are consistent with those in PP, supporting that this is a non-inferiority study and the primary efficacy population was PP not ITT. 76 subjects were excluded from primary efficacy analysis mainly due to essential data missing or invalid, violation of inclusion/exclusion criteria and insufficient duration of therapy.
753966|NCT00453336||
753967|NCT00453310||
753968|NCT00453206||
753969|NCT00453193|Recruitment Period: 8/241/2004 to 5/12/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.|Of the 26 enrolled, only 24 patients were included in this study.
753970|NCT00453180||
753971|NCT00453154|Between March 2007 and December 2011, 156 participants were recruited.|
753972|NCT00453102||
753973|NCT00453063||
753974|NCT00452868|patients were registered from 9/11/2006 to 5/14/2009|13 unique patients were recruited, one patient twice after failing to start therapy the first time, two patients were not evaluable, leaving 11 patients for analysis.
753975|NCT00452790||708 participants were enrolled and 709 were randomized into the study. One infant in the 13vPnC group was randomly assigned twice because of technical difficulties with the first random assignment. Though this infant participated in the study only once, both random assignments were included in the 354 participants in the 13vPnC group.
753976|NCT00452699||
753979|NCT00452530||Of 3221 patients enrolled, 3057 were randomized. Primary participants=those who were randomized and had an adjudicated evaluable bilateral venogram or an adjudicated venous thromboembolic event or died. Evaluable participants=those with significant protocol deviations expected to affect the primary endpoint.
753980|NCT00452452|Participants were recruited in Poland from July 2007 to September 2007.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
753981|NCT00452439|Recruitment Period: February 06, 2004 to March 10, 2010. All participants were recruited at University of Texas (UT) MD Anderson Cancer Center.|
753982|NCT00452426||
753983|NCT00452400||409 patients were enrolled to the study, however 4 patients were assigned incorrect medication, so these patients were re-randomised, so only 405 patients actually started the study.
753984|NCT00452387|10 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in May 2007 and was closed in July 2008 after the interim analysis was completed.|Informed consent was obtained from all subjects. All subjects underwent a screening period that could last up to 4 weeks during which pre-study assessments were completed.
753985|NCT00452374|Recruitment Period: 11/15/04 to 4/24/07. All patients registered at the University of Texas MD Anderson Cancer Center.|
753986|NCT00452361|Patients were recruited in Taiwan from April 2007 to May 2008.|After consent and eligibility criteria patients needed to be receiving: triple therapy with a Calcineurin Inhibitor (CI) (tacrolimus or cyclosporine) that began at the time of transplantation or ≤2 weeks thereafter and corticosteroids plus either mycophenolate mofetil (MMF)/mycophenolate sodium (MPS) or azathioprine (AZA) for at least 12 weeks.
753987|NCT00452348||
753988|NCT00452335||127 participants were randomized to study treatment, however only 124 participants received study drug
753989|NCT00452114||
753990|NCT00451958|All participants who completed the CS21 study (NCT00295750) were eligible to enrol into the CS21A extension study. Since the number of participants who completed this long-term study was low, no firm conclusions can be drawn from the results.|Initially, participants treated with degarelix during CS21 continued to treatment and patients who received treatment with leuprolide during CS21 were re-randomised to one of the two degarelix treatment regimens. Following a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg for the rest of the study.
753991|NCT00451906|This study was conducted at 384 sites in 39 countries from 21 August 2006 to 30 June 2009.|A total of 2252 participants were enrolled into the study, of which 2172 received the study drug. A total of 80 randomized participants did not receive study drug.
753992|NCT00451698||
753993|NCT00451555||Completers include participants who had died from any cause, who discontinued due to progressive disease or were alive and on study but no longer receiving treatment at end of the study.
753994|NCT00451451|Subjects were randomized at 205 investigational sites in 28 countries.|From screening, 1430 eligible subjects were equally randomized. Of these, 1417 subjects received at least one dose of study treatment and comprised the intent-to-treat (ITT) and safety populations.
753995|NCT00451321|The study was conducted at 17 centers from United States and Canada during the period 31 July 2006 to 1 December 2011.|Participants from all 7 cohorts who had received a total dose <3.0 milligrams (mg) were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
753996|NCT00451282|Potentially eligible injured patients were identified from patient census and administration lists (n=1330; April 2007 - October 2008). Of 845 eligible children, 149 refused participation, 406 were not approached, usually due to limited parent availability.|290 children were enrolled for risk screening, of these 85 (29%) scored positive on one or more screening measures for PTSD and were randomly assigned to receive usual care or the intervention (n=39 and n=46 respectively). 5 intervention subjects did not end up receiving the allocated intervention.
753997|NCT00451217|Participants who had a surgical procedure using a general anesthesia of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block were enrolled in this study.|
753998|NCT00451204||
753999|NCT00451191|Patients were recruited at the 7 clinical centers (Baylor College of Medicine, Houston TX; Cornell University, New York NY; Mayo Clinic, Rochester MN; Medical College of Wisconsin, Milwaukee WI; Northwestern University, Chicago IL; University of Colorado Denver, Aurora CO; University of Texas Southwestern Medical Center, Dallas TX).|Screening for eligibility: male, 50+ years old, signed informed consent, no prior surgical treatment for BPH and no prior use of botulinum toxin, appropriate washout period for medical therapy, American Urological Association Symptom Index (AUASI) >=8, voided volume >=125 ml, maximum urinary flow rate <15 ml/sec.
754000|NCT00451178||Study included chemotherapy, maintenance therapy (only R-CHOP and enzastaurin treatment arm) and follow-up post treatment for long-term efficacy.
754001|NCT00451048||
754002|NCT00450983||
754003|NCT00450866|This was a multicenter conducted at the Cleveland Clinic, University Hospitals Case Medical Center, Massachusetts General Hospital, Memorial Sloan Kettering Cancer Center, and the University of Michigan.Fifty five patients were treated on this study between February 2007 and May 2010, all of whom are considered eligible.|
754004|NCT00450814||Phase I: INITIALLY CLOSED ON 12/17/2009 AND STAGE 2 BEGUN; HOWEVER, DUE TO NEW MANUFACTURING CAPABILITIES, STAGE 1 RE-OPENED ON October 13, 2011, FOR DOSE LEVELS 5 AND 6. Phase II: Accrual to Cohort A closed due to failed interim analysis. Cohort B closed due to lack of accrual.
754005|NCT00450801||
754006|NCT00450749|Recruitment Period: April 11, 2008 to April 15, 2009. All recruitment was done in a medical clinic setting, and all participants enrolled at Memorial Sloan-Kettering Cancer Center.|There were eleven participants registered, one participant was excluded from the trial before assignment to groups making only ten randomized.
754007|NCT00450723|Between 2001 and 2007 a prospective database was obtained of all patients undergoing internal mammary sentinel lymph node biopsies using an open or thoracoscopic approach. Radiotracer injection was peritumoral.|
754008|NCT00450658|A multi-center US study in which 80 sites recruited subjects between March 2007 and February 2008.|Following screening for eligibility and wash-out of restricted medications, subjects were assigned according to the treatment to which they were randomized in a 2:1 ratio (HZT-501:ibuprofen).
754009|NCT00450619||
754010|NCT00450580||
754011|NCT00450463||Primary focus of this study compares flutamide with/without vaccine. While patients could get vaccine alone after flutamide progression, this was not a primary focus of the study. With only 11 patients, this group was an exploratory endeavor and there was no statistical plan for comparison to the primary groups.
754012|NCT00450450||
754013|NCT00450437|Participants were enrolled at 44 centers in the US.|All subjects enrolled were included in the trial. All enrolled subjects were randomized at a 1:1:1:1 ratio to receive one of the four vaccine groups.
754014|NCT00450424||
754015|NCT00450411||
754016|NCT00450385|A total of 60 patients were consented, however, only 57 of these patients were found to be eligible for enrollment per the protocol.|
754017|NCT00450372||
754018|NCT00450333|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|Erythropoietin (EPO)-naive subjects were randomized to receive Dynepo (Epoetin delta) once weekly (QW) or twice weekly (BIW) and subjects who were already stable on EPO (doses < or equal to 10,000 IU/week) were randomized to receive Dynepo once every 2 weeks (Q2W) or once weekly.
754019|NCT00450294|Ten patients were recruited into the study after informed consent at the preoperative anesthetic clinic during a twelve month period.|Because this is a purely OBSERVATIONAL STUDY, there was no group assignment. All patients enrolled in the study were assigned to one group, that is, all patients had intraocular pressure measurements performed.
754020|NCT00450255||
754021|NCT00450242|A total of 14 subjects were recruited via advertisement and clinical referrals from within the medical center and from the community of referring physicians.|
754022|NCT00450216||
754023|NCT00450190||
754024|NCT00450177||
754025|NCT00450112||A total of 202 patients were entered.
754026|NCT00450073|Please see full manuscript|Please see full manuscript
754027|NCT00449956|"Phase III.
~Studied period: April 9, 2007 (date study therapy started for the first subject) to February 16, 2008 (the last subject's last visit stipulated in study protocol). Study was conducted at 67 clinical sites."|Outpatients with primary open angle glaucoma (broad definition) and/or ocular hypertension received 4-week timolol 0.5% monotherapy in the wash-out period before the study randomization.
754028|NCT00449930|"First patient In: 04-Apr-2007
~Last Patient Last Visit: 25-Jul-2008
~113 study centers worldwide"|Patients 18-78 years of age with Type 2 diabetes mellitus (T2DM) who were not on anti-hyperglycemic agents for at least 4 months (16 weeks) and with a hemoglobin A1c (HbA1c) of ≥ 6.5 and ≤9.0%
754029|NCT00449865||
754030|NCT00449787||
754031|NCT00449748|Recruitment Period 4/11/2007 to 4/15/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.|
754032|NCT00449696||A total of 598 patients were screened.
754033|NCT00449670||
754034|NCT00449644|This trial consisted of an exploratory stage (Stage 1) and a proof-of-efficacy stage (Stage 2). Different participants were enrolled in each stage. Participants in Stage 2 who met protocol-specified criteria were offered open-label treatment with TMC207 after Week 24 (ie, rollover arm).|A total of 208 participants were randomized and 207 (47 participants in Stage 1 and 160 participants in Stage 2) started treatment with placebo or TMC207 (1 participant did not receive study drug). One placebo participant in Stage 2 rolled-over to treatment with TMC207 after Week 24.
754035|NCT00449540||267 participants enrolled in the 30 day Lead-In phase as described. 66 participants did not experience migraine in the 30 days allotted and therefore were not moved to the treatment phase. 201 participants were moved to the treatment phase
754036|NCT00449176|The recruitment period for this out-patient, multicenter study occurred between 21 February 2007 and 12 March 2008.|The study consisted of a screening period (duration up to 14 days), a washout period (duration 3 to 7 days), a double-blind active treatment period with titration period (duration 3 weeks) and maintenance period (duration 12 weeks).
754037|NCT00449163||A total of 25 subjects were enrolled however; data were analyzed for only 22 of the subjects enrolled.
754038|NCT00449150||
754039|NCT00449072|The study was conducted between 14 March 2007 (first subject enrolled) and 12 October 2011 (last subject last visit) at 69 active centers located in the US.|299 participants were randomized, 298 were treated.
754040|NCT00449046||
754041|NCT00449033|This study was conducted at 93 centers across 16 countries, which enrolled and randomized at least one patient. From a total of 1011 patients who were screened, 904 patients were randomized between 23 FEB 2007 and 03 MAR 2009.|All 904 randomized patients were included in the intent to treat (ITT) population. A total of 901 patients received at least one dose of study medication and were included in the safety population. Study medication included administration of any one of the following treatments: gemcitabine, cisplatin, sorafenib or placebo.
754042|NCT00448916|This study was a dose extension study of pediatric participants with refractory partial-onset seizures who had completed study A0081074 (NCT00437281). Participants were enrolled in 3 countries at 13 study centers with 13 investigators: Republic of Korea (1 center), Mexico (1 center), and the United States (11 centers).|Each participant was restricted to the dose levels that they had previously tolerated, or that had shown acceptable safety and tolerability in study A0081074 (NCT00437281) for the participant's age group.
754043|NCT00448864||
754044|NCT00448760||
754045|NCT00448747|"Overall, 53 AGHD patients and 48 matched control subjects were enrolled at 11 centers across the United States, and all subjects, with the exception of 1 AGHD patient, received macimorelin and completed the study.
~In Amendment No. 4, the objective of the study was changed to delete the comparison with L-ARG + GHRH."|
754046|NCT00448708||
754047|NCT00448682||
754048|NCT00448669||
754049|NCT00448630|Subjects diagnosed with schizophrenia who have been using or recommended to use atypical antipsychotic drugs.|
754050|NCT00448591||
754077|NCT00447057||This is a 2-arm study; however, results for participant disposition and baseline characteristics are presented for 4 groups including each study arm (Pemetrexed and Pemetrexed + Erlotinib) by histology (Nonsquamous and Squamous). Efficacy results are presented for participants with nonsquamous histology only.
754051|NCT00448539|Participants who completed double-blind study E2080-A001-301 were allowed to enter in open-label extension Study 302. Participants completed a 12-day Transition Phase in Study 301 and received the same rufinamide maintenance dose that they achieved in Study 301 (Arm1), or transitioned from placebo to 3200 mg/day, beginning at 800 mg/day (Arm2).|Four participants who intended to enroll from Study 301 to 302 did not enroll and were considered screening failures.
754052|NCT00448448|Subjects were recruited from 25 centers in the US and Canada (see list of participating centers). The first subject was enrolled in April 2007 and the last in February 2011.|
754053|NCT00448435||
754054|NCT00448357|Patients with advanced, refractory, or high-risk hematologic cancers who were deemed suitable for myeloablative conditioning were recruited from one institution.|A total of 55 subjects were consented, but one subject was not enrolled due to disease progression or death prior to protocol therapy.
754055|NCT00448344||
754056|NCT00448279||
754057|NCT00448227||
754058|NCT00448201|Patients with histologically confirmed hematologic malignancies, who were over the age of 55, or otherwise ineligible for more intensive busulfan-based therapy were enrolled on protocol Lineberger Comprehensive Cancer Center (LCCC) 0306 at the University of North Carolina.|
754059|NCT00448175|Subjects were recruited by investigator sites with limited advertising|"After 12 weekly PTNS treatments, 35 patients were considered responders (reporting of Moderately or Markedly improved on the Global Response Assessment (GRA))and allowed to continue in the trial through 12 months."
754060|NCT00448136||
754061|NCT00448123|127 subjects were enrolled in the study and 100 completed the study. Of the 27 that were excluded from analysis, 15 were excluded due to 'lost to follow-up', and another 12 had their stone removed surgically (physician decision) by the 7th day.|
754062|NCT00448019|Recruitment Period: February 23, 2007 to November 17, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.|
754063|NCT00447902|With FDA and EMEA agreement, the trial was prematurely discontinued before reaching the target number of patients to be entered due to poor recruitment. For this reason analyzing and reporting data as planned for primary and secondary endpoints have not been performed. No objectives were reached and no conclusion can be drawn from this study.|One patient has been randomised by mistake in Brasil and so he was not treated
754064|NCT00447876|The study was a double-blind, placebo-controlled, randomized, prospective study where patients were recruited to 5 study centres in Germany. Patients were enrolled to the study from 08 July 2005 (first patent enrolled) until 23 April 2009 (last patient completed).|40 patients were enrolled. Patients were assigned to treatment if they met all inclusion and none of the exclusion criteria. All patients enrolled were randomized and received study treatment.
754065|NCT00447772|First patient enrolled (signed informed consent) 28 Oct 2004, last patient completed 4 April 2008. 516 patients were recruited to this prospective, open, multicentre study at 77 study centres in Germany and 4 study centres in Austria.|To be eligible patients had to have 2 of the most frequent forms of cervical dystonia (CD): rotatory torticollis or laterocollis.
754066|NCT00447603|The study was discontinued early due to limited availability of sites and readiness of sites to enroll participants within the predefined time. Although some participants were screened and entered Filter Period, none were randomly assigned to a treatment arm and none entered double-blind treatment period.|Enrolled participants entered screening. If initial criteria were met, eligible participants were separated into 2 strata based on weight and administered either 25-50mg or 50-100mg Losartan during Filter Period. Participant's whose blood pressure did not respond were eligible to be randomly assigned to the Treatment period of the study.
754067|NCT00447590||"174 participants were enrolled in the study, where enrollment was defined as signing the informed consent form.
~21 participants were not implanted after signing the informed consent. 153 participants were treated with the LAP-BAND."
754068|NCT00447499|First patient enrolled on 6/28/2007 and last patient completed on 12/11/2008. The study enrolled patients with a diagnosis of acromegaly due to a pituitary tumor. patients were recruited from the patient populations of participating investigators and from referrals from other clinics and private practices. A competitive recruitment was used.|Patient had been treated with a long-acting somatostatin analog for at least 3 months prior to Screening, must have had IGF-1 levels < 10% above the upper limit of normal range, OR the patient was somatostatin analog-naïve (if the patient was treated with a dopamine agonist, he/she must have been on the dose for >= 3 months prior to Screening)
754069|NCT00447421||This was a Phase 1/2 trial that was terminated during Phase 1 and never progressed to Phase 2. The number of patients enrolled is for the Phase 1 portion.
754070|NCT00447382|Twenty four sites in five countries: Germany (12), The Republic of Macedonia (1), Russian Federation (4), Serbia (3) and South Africa (4)|Eligible subjects were adults with type 1 diabetes treated with a basal-bolus regimen for at least 3 months prior to the study, who had a BMI (Body Mass Index) no greater than 35.0 kg/m^2 and HbA1c no greater than 12.0%.
754071|NCT00447330||81 subjects consented, 21 were screen failures, 60 subjects were considered enrolled.
754072|NCT00447278||Study consisted of a 1 week screening (Period I); 6 months open-label (Period II); Optional additional 6 month open-label extension (Period III).
754073|NCT00447265|Participant recruitment occurred at 6 sites. All sites were affiliated with a university and utilized a lupus clinic and outside referrals for recruitment. The first site (UCSF) was activated on 1 Feb 2008. The remaining 5 sites (Feinstein, Rochester, Colorado, Duke, and UAB) were activated over the next year.|The participant signed an informed consent before study screening procedures commenced to assess eligibility criteria (lupus diagnosis with active nephritis, positive ANA, presence of dsDNA antibodies, and stable medication regimens of either mycophenolate mofetil (MMF, CellCept®, Myfortic®) or azathioprine at the screening visit.
754074|NCT00447226||"Participants maintaining stable disease (SD) in Stage 1 (open label) were randomized to double-blind lapatinib 1500 milligrams (mg)/day or placebo (Stage 2). Of 32 participants in Stage 1, 7 maintained SD and were randomized into Stage 2. These 7 participants are represented as completed in the Open-label Phase participant flow table."
754075|NCT00447122|31 patients were enrolled, 29 were evaluable|
754076|NCT00447083||
754104|NCT00445692||32 patients were enrolled. 31 patients started therapy. 1 patient was consented but was deemed ineligible prior to therapy initiation.
754078|NCT00447005||Six participants initially received a single dose of AG-013736 5 mg followed by 5 mg twice daily (BID) multiple dosing. They were monitored for dose limiting toxicity (DLT) up to multiple dosing Cycle 1. Since no more than 1 of the first 6 participants had a DLT, 6 additional participants initiated AG-013736 from multiple dosing per the protocol.
754079|NCT00446992|Hospital Clinic of Barcelona|
754080|NCT00446966|The recruitment period was from February 2007 to December 2009. Patients were recruited from cardiothoracic clinic.|
754081|NCT00446849||A total of 290 subjects were enrolled in the study (138 in the acute phase and 152 that went directly into the maintenance phase). The 56 subjects that completed the acute phase entered the maintenance phase making a total of 208 subjects in the maintenance phase of the study.
754082|NCT00446797|Locations used were emergency rooms at orthopedic hospitals, general hospitals or private doctor's offices|Subjects sustained ankle sprain with a pain rating of greater than or equal to 45mm on a visual analog scale on full weight bearing, no more than 48 hours prior to the first dose of study medication
754083|NCT00446654|The recruitment period spanned 05 February 2007 to 10 July 2007. Patients were randomised to one of the two treatment groups. Treatment group assignment for each patient was made centrally.|
754084|NCT00446641|244 patients with subacute or chronic ischemic stroke were recruited from outpatient clinics of 5 comprehensive stroke centers of Korea|"Patients with aspirin therapy were recruited due to subacute or chronic ischemic stroke.
~The patients should have taken aspirin 100mg per day at least 2 weeks before randomization"
754085|NCT00446563||
754086|NCT00446550||Confirmatory β-glucosidase (GBA) genotype testing was done at screening to confirm reported genotype (with the exception of participants enrolled in Israel).19 participants received at least 1 dose of study drug. All participants were eligible for inclusion in both the safety and the pharmacodynamics (PD) populations.
754087|NCT00446511||
754088|NCT00446459|All study subjects were recruited from University of Washington Medical Center's kidney transplant wait list. Patients with a Panel of Reactive Antibodies (PRA)over 50% for 6 months or longer between 18 and 75 year of age were contacted by letter and then by phone to schedule screening visit. Enrollment occured from 4/24/06 to 9/06/07.|Subjects were consented, given a physical exan and laboratory tests including serum virologies current Hepatitis B immunization and Tuberculosis (TB) testing initially. Abnormalities in white or red blood cells, platelets, TB test or signs of infection or evidence of cancer were grounds for exclusion.
754089|NCT00446446|A total of 65 patients with metastatic or recurrent squamous cell carcinoma of the head and neck were screened of whom 52 were enrolled at 22 study centers in North America (20 study centers) and Australia (2 study centers) between October 2007 and December 2009.|Results are reported for the primary analysis with a data cut-off date of 16 December 2010.
754090|NCT00446290||
754091|NCT00446264|Recruitment period: 2003-2006 University Lille Hospital|
754092|NCT00446251|"Subjects were recruited from the parent study: Highly Sensitized Patients: effects of mycophenolate mofetil (MMF) on anti-human lymphocyte antibody levels in patients awaiting renal transplant study at 8 months if the subject had not experienced a 10% or greater reduction in Panel of Reactive Anti-bodies(PRA."|Single arm study: all subjects received 2 Rituximab infusions of 1,000 mg. Subjects were kept at their highest tolerated dose of mycophenolate mofetil(MMF)from parent study.
754093|NCT00446199|The study was conducted at 79 centers in the United States from 26 Mar 2007 (date of first participant's first visit) to 03 Nov 2008 (date of last participant's last visit)|2457 Screened; 1722 Screen Failures; 735 randomized; 726 treated (Safety Analysis Set, SAF); 710 Full Analysis Set (FAS, randomized subjects with Baseline vasomotor symptom (VMS) data, took ≥1 study dose plus ≥1 VMS data day postdose); 569 Per Protocol Set (PPS, all subjects in FAS with ≥75% study drug compliance and no major protocol violations).
754094|NCT00446147||
754095|NCT00446134|Patients who met all entry criteria and signed an informed consent were randomized in a 1:1:1:1 ratio to one of the 4 arms by a central randomization schedule. A total of 51 clinical centers in the United States participated in the study. 278 patients were randomized; 275 patients who receive one dose of study drug were included in all analyses.|Randomization was stratified by screening HCV RNA viral load less than or = to 2 or greater than (>) 2 million copies/mL and body weight (BW) (less than or = 75 or >75 kg). A cap of 70% was set for patients with BWs >75 kg so that at least 30% of the patients in each group have BWs less than or = to 75 kg.
754096|NCT00446095|A total of 81 patients with lymphoid malignancy were enrolled from 22 March 2007 until 31 January 2008, of which 13 were in Phase I and 68 in Phase II. This study was conducted by 11 investigators at 11 sites in U.S. Primary efficacy analysis was based on Phase II patients so only results from Phase II are posted.|There was screening period of up to 21 days, after which if all inclusion/exclusion criteria were met, patients were dosed with fostamatinib treatment for a treatment period of 8 weeks. Patients could then continue treatment until disease progression, toxicity or withdrawal from the study
754097|NCT00446030|A total of 127 participants were registered for this study, and stratified for treatment based on their HER2 status. 93 participants were in Stratum 1 (HER2 negative) and 34 were in Stratum 2 (HER2 positive). One participant in Stratum 1 discontinued at her own request prior to receiving any treatment, but was allowed to enter follow-up.|
754098|NCT00445939|Subjects with moderate to severe Crohn's Disease (Crohn's Disease Activity Index [CDAI] >= 220 and <= 450) were enrolled into study. The period from the first dose of study drug to the evaluation at Week 4 is Period A. The period from the study drug injection at Week 4 to the evaluation at Week 8 is Period B.|All subjects were evaluated at Week 4. If responders (CDAI decrease >= 70 points compared to Baseline), rolled over to a maintenance study. If non-responders (CDAI decrease of < 70 points compared to Baseline), continued in study and received: adalimumab 160/80 mg + 40/40 mg, or adalimumab 80/40 mg + 40/40 mg or placebo + adalimumab 160/80 mg.
754099|NCT00445887|The protocol opened to accrual 03/10/2008 and closed 11/26/2012Women who were are at increased risk for ovarian cancer and were intending to undergo prophylactic salpingo-oopherectomy were randomized to Levenorgestrel (0.15 mg/day) or Placebo for 4 to 6 weeks.|
754100|NCT00445848|89 patients were enrolled. Four patients were excluded from the analysis: two patients were ineligible due to incorrect histology; two were no analyzable due to their not receiving any treatment on protocol.|
754101|NCT00445770||
754102|NCT00445744||
754103|NCT00445705||
754105|NCT00445679|Subjects were recruited in China, India, South Korea and Taiwan from July 2007 to December 2008.|After a 4 to 21 day screening period, eligible subjects were treated for up to 8 weeks.
754106|NCT00445601||
754107|NCT00445588|"Adult pts accured in an outpatient clinic between Jan 2007 and October 2007.
~pts had to have measurable , histologically proven GBM, that had progressed following radiation therapy and 0-2 prior chemotherapies."|
754108|NCT00445549|If 2-3 patients per month enroll onto this trial, it is expected that approximately one and a half years will be required to enroll the 35 evaluable patients required for evaluation in this study. To make an allowance for a small drop-out of patients from the study and still preserve the intended accrual goal, the total accrual will be38 patients.|
754109|NCT00445484||
754110|NCT00445458||
754111|NCT00445432||
754112|NCT00445341||
754113|NCT00445328||
754114|NCT00445315||
754115|NCT00445302||Cohort enrollment into the study was staged based on baseline creatinine clearance levels, with moderate renal impairment and control participants enrolled first. Severe renal impairment were enrolled following completion of the moderate renal impairment. Participants with mild renal impairment were enrolled last.
754116|NCT00445263||
754117|NCT00445224|33 females with anterior knee pain (PFPS) volunteered to participate in this study. Enrollment began August 2007 and last subject was enrolled in August 2009.|Subjects were evaluated for PFPS using the following:(1)anterior knee pain reported during at least 2 activities: stair climbing, running, squatting, kneeling, and prolonged sitting;(2)insidious onset of symptoms ;(3)pain with compression of the patella; and(4)pain on palpation of patellar facets. Only three patients were excluded during study.
754118|NCT00445211||
754119|NCT00445146|Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 26 February 2007. The last study visit occurred on 24 March 2015.|Participants must have been enrolled in other Gilead-sponsored studies of elvitegravir (EVG) + ritonavir (RTV) to be eligible to receive continued access to EVG+RTV in this study.
754120|NCT00445003|Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield >=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.|Participants with 2 study eyes enrolled each eye in a different arm. Each treatment arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
754121|NCT00444951|Participants were enrolled from 17 February 2007, to 01 July 2007, in 7 clinic centers in Saudi Arabia.|A total of 450 participants who met the inclusion and exclusion criteria were enrolled, and 446 were vaccinated.
754122|NCT00444925|Participants with urgency incontinence Overactive Bladder (OAB) symptoms who met all entrance criteria were randomized to the double-blind treatment period.|
754123|NCT00444912||
754124|NCT00444821||
754125|NCT00444795|This post marketing surveillance (PMS) study enrolled 520 participants between December 2007 and March 2015. Data from 100 participants were obtained from a previously completed study (A6181037).|
754126|NCT00444678||
754127|NCT00444626||166 subjects screened, 26 subjects were never randomized.
754128|NCT00444600|Fifty two academic and community based sites across the United States recruited 691 study participants from March 2007 to December 2008.|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
754129|NCT00444587|A total of 114 participants were enrolled in this study conducted from March 2007 to August 2011 at 30 centers in 8 countries.|Of 114 participants screened, 3 participants were screening failures. The reasons for screening failure were violation of inclusion criteria, refused to take part in the study and bacterial infection. Therefore, 111 participants were randomized to receive study treatment. Two participants were randomized but never started study treatment.
754130|NCT00444535||
754131|NCT00444457||
754132|NCT00444275|Patients were recruited by general practitioner between March 1, 2007 and July 21, 2008|"The study included 2 phases (maximum treatment duration = 16 weeks):
~one initial treatment phase of 4 weeks
~one randomized maintenance treatment phase of 12 weeks only for patients whose initial treatment is considered to be successful at the end of the initial phase.
~Only maintenance phase data were reported in the Baseline module measures."
754133|NCT00444145||
754134|NCT00444106||
754135|NCT00444080||
754136|NCT00444067|The first subject was consented on May 15, 2007. The last subject visit occurred on August 12, 2009.|Washout study, no run-in or wash-out periods.
754137|NCT00444028|Fifty subjects were recruited by and studied in the clinical researech unit (CRU). Study dates: 30 September 2005 through 22 November 2005|To obtain 50 enrolled subjects, screening procedures and inclusion/exclusion criteria were evaluated for 126 subjects during a variable screening period of up to 21 days. No enrolled participants were excluded from the trial.
754138|NCT00443898||
754139|NCT00443872|Parkinson's disease (PD) patients with levodopa-induced motor fluctuations were enrolled at 12 sites in the United States. The first subject was enrolled in March 2007, and the last subject completed in September 2008.|Excessive daytime sleepiness was defined by an Epworth Sleepiness Scale (ESS) score greater than 10; pedal edema was bothersome to the subject; hallucinations were bothersome, but insight was maintained; and impulse control disorders (ICDs) included behaviors not requiring immediate medical attention and not harmful to the patient or to others.
754140|NCT00443846|A total of 249 participants were screened and 247 were randomized.|
754141|NCT00443820|This randomized, double -blind, vehicle -controlled, multicenter, parallel group study was designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine hydrogen chloride 10% topical solution (TTS10%) applied daily in patients with toenail onychomycosis. Started 07 DEC 2006 and ending 27 JUN 2008.|
754142|NCT00443781||
754143|NCT00443755|The study was conducted between 8/19/2005 and 8/24/2010 at the Mayo Clinic in Rochester, Minnesota.|48 Northern European Americans were assessed for eligibility and of those, 20 did not meet inclusion criteria.
754144|NCT00443729|"Phase III; First Patient In: 11-Jun-2007; Last Patient Last Visit for Week 24 (primary endpoint): 17-Oct-
~2008
~34 Sites (US, Peru, Brazil, Colombia, Mexico, South Africa, Thailand, India, and Australia)."|HIV-seropositive patients who were ≥18 years old, had documented HIV RNA <50 copies/mL for at least 3 months, had been on a KALETRA™-based regimen for at least 3 months without a change in background antiretroviral therapy, and had no documentation of HIV RNA >50 copies/mL for at least 3 months.
754145|NCT00443703|"Phase III; First Patient In: 20-Jun-2007; Last Patient Last Visit for Week 24 (primary endpoint): 31-Oct-2008
~47 Sites (US, Canada, Denmark, Germany, Italy, Portugal, Spain, United Kingdom, and Australia)."|HIV-seropositive patients who were ≥18 years old, had documented HIV RNA <50 copies/mL for at least 3 months, had been on a KALETRA™-based regimen for at least 3 months without a change in background antiretroviral therapy, and had no documentation of HIV RNA >50 copies/mL for at least 3 months.
754146|NCT00443651|The study was conducted in 2 stages. Stage I: Patients with an inadequate response to non-biological disease-modifying antirheumatic drugs (DMARDS) were treated with rituximab 1000 mg. Stage II: Patients with an inadequate response to a biological DMARD were treated with rituximab 500 mg. Both groups continued to receive DMARDs.|One Stage 1 patient was enrolled but did not receive treatment with rituximab, is not included in the Participant Flow data, and was not included in any of the analyses.
754147|NCT00443599|Enrollment began in September 2006 and ended in May 2012. All subjects received the study intervention in the Cardiac ICUs at Boston Children's Hospital (Boston, MA) and C.S. Mott Children's Hospital (Ann Arbor, MI).|Participants gave consent prior to cardiopulmonary bypass (CPB) surgery, randomization occurred perioperatively and initiation of the protocol occurred postoperatively. 9 subjects were removed from the study between the time of randomization and initiation of the protocol (4 for cancellation of CPB , 3 for physician decision, 2 for death).
754148|NCT00443560|The Obstetric Anesthesiology Database was used to identify parturients from the Labor and Delivery Unit of Prentice Women's Hospital of Northwestern Memorial Hospital who qualified for the study between January 2004 and October 2005.|
754149|NCT00443547||
754150|NCT00443534|All participants were recruited from following previous sunitinib trials: NCT00798889, NCT00092001, NCT00137449, A6181049, A6181051, NCT00113516, NCT00265317, NCT00137423, NCT00267748, NCT00243503, NCT00471276, NCT00174434, NCT00528619, NCT00372775, NCT00417885, NCT00428597, and NCT00372567.|
754151|NCT00443456||Among subjects who had completed the preceding study (A0531085, NCT00415623), where either Amlodipine 5 mg or 10 mg was administered for 8 weeks, those who were considered to be eligible for enrollment in this long-term study, based on safety and efficacy of the preceding study and who had a treatment compliance rate of at least 80% were enrolled.
754152|NCT00443430|85 children with poly JIA within 12 months of onset recruited from pediatric rheumatology clinics at 15 sites|Eligible patients were permitted to have received up to 2 intra-articular corticosteroid injections before or up to 2 weeks after baseline; and oral prednisolone for up to 4 weeks, but must have been off corticosteroids for at least 1 week prior to enrollment. Patients with past or current JIA-associated uveitis were excluded.
754153|NCT00443352||
754154|NCT00443261||
754155|NCT00443209||The trial was considered to have achieved completion as defined by the treatment of 100 participants for 12 months.
754156|NCT00443118||
754157|NCT00443053||
754158|NCT00443040||
754159|NCT00442962|Study participants were recruited at 8 sites from 3 countries: 6 in the US, 1 in Brazil, 1 in Peru, between May 2007 to December 2009.|HIV-infected women, at least 16 years of age, whose only prior exposure to anti-retrovirals (ARVs) was for the purpose of prevention of mother-to-child transmission, who now qualify to start ARVs for their own health.
754160|NCT00442936||
754161|NCT00442897|Patient were recruited between September 2006 and May 2008.|Patients who were naïve to lipid-lowering agent or patients who were treated with lipid-lowering agent and had 4 week' wash-out period were enrolled in the study. The eligible patients will be allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio.
754162|NCT00442767|Eight study subjects were screened and all subjects completed both study visits.|
754163|NCT00442702||
754164|NCT00442689||97 total subjects enrolled. Prior to randomization, 16 subjects were excluded or dropped out, leaving 81 active subjects. Early in the study, 2 of the 5 study arms were discontinued: participants receiving Metformin only (8 subjects) and those receiving Metformin + Flutamide (6 subjects) - leaving 67 subjects whose data were analyzed
754165|NCT00442611||
754166|NCT00442598||
754167|NCT00442572|All participants in this study were enrolled at one centre in Bulgaria from 03 July 2006 to 23 April 2012. Of the 21 participants enrolled, 17 participants were randomized to PEGASYS arm and 4 participants were randomized to no intervention arm.|
754168|NCT00442559|Conducted at 5 sites in Korea, Jan2005~ Oct2007 in pediatric participants with comorbid mild asthma and allergic rhinitis. Participant's caregiver understands the study procedures and agrees to participate, signing the informed consent form.|Up to 1 week for wash-out - prior to baseline randomization.
754169|NCT00442546||
754170|NCT00442507|The study opened to participant accrual on 03/16/2007 and closed to participant accrual on 01/21/2009.|
754171|NCT00442468||
754172|NCT00442416|This study was conducted in the United States from 27 February 2007 to 01 January 2008. The study was prematurely terminated during enrolment due to legal reasons.|A total of 80 participants were randomized, of which 78 participants received the study drug and 2 participants did not receive the study drug nor had post baseline safety assessments.
754173|NCT00442364||
754174|NCT00442351||
754175|NCT00442338|"Phase III.
~Studied period: March 12, 2007 (date study drug was first administered to first participant) to August 1, 2007 (date study drug was last administered to last participant). Study was conducted at 31 clinical sites."|Participants with acute exacerbation of bronchial asthma received standard treatments of inhaled β-agonist or oxygen inhalation to treat the acute exacerbations during the 60 minutes in the screening period before the study randomization.
754176|NCT00442286||Of the 591 patients enrolled, 78 withdrew prior to implant and 187 screen-failed. 4 implants were unsuccessful, and 2 randomized patients were terminated prior to the randomization visit. 55 patients were roll-in patients that were not randomized. A total of 265 patients were both randomized and implanted.
754177|NCT00442169|Participants were enrolled from 09 December 2005 to 27 March 2006 in 5 clinical centers in the US.|A total of 208 participants (Part 1 = 112; Part 2 = 96) who met the inclusion and exclusion criteria were enrolled, randomized, and vaccinated in the study. Report on Part 1 and Part 2 participants with valid data are presented in this report.
754178|NCT00442117||A total of 180 participants were enrolled and randomized. There were 8 participants who had taken at least one dose of study medication, but were not eligible for the study and therefore were withdrawn, resulting in the Intent-to-Treat (ITT) population of 172 participants.
754179|NCT00442013|Conducted from April 2007 to April 2011|
754180|NCT00441974||
754181|NCT00441883||
754182|NCT00441792|Patients eligible for this study were enrolled from November 2007 until May 2009. Patients were eligible if they were older than 18 years, were intubated in the ED, and had a suspected infectious cause for their illness.|
754183|NCT00441766||
754184|NCT00441727|The first subject was randomized 22 February 2007 and last subject completed 28 August 2008. Cardiologists, primary care physicians and gastroenterologists were the primary target investigators.|
754185|NCT00441701||
754186|NCT00441584||The majority of subjects who discontinued due to treatment failure were withdrawn from the study as non-responders according to protocol requirements.
754187|NCT00441558||
754188|NCT00441545|Following Washout 1, eligible subjects with serum phosphorus levels greater than or equal to 6.0mg/dL (greater than or equal to 1.94mmol/L) and calcium levels greater than or equal to 8.4mg/dL (greater than or equal to 2.10mmol/L) were randomized in a 1:1 ratio to receive either Fosrenol or sevelamer hydrochloride (HCl) for 4 weeks.|The study consisted of the following phases: screening (1 week), washout 1 (2 weeks), treatment (4 weeks), Washout 2 (2 weeks), crossover treatment (4 weeks), and a 30-day follow-up
754189|NCT00441480|Recruitment period:r May 2007-Jan 2008 (8 months) Medical center|10 -14 days run-in phase during which they received placebo capsules. Run-in phase enabled to exclude subjects who had an unstable weight (gained or lost more than 3 kg) during this period or who didn't meet entry criteria of LDL-c and TG at screening visit and at baseline visit.
754190|NCT00441467||
754191|NCT00441441|A total of 351 participants were enrolled in the study. However, only 350 of these 351 participants comprised the Intent-to-Treat Population, defined as all participants who were randomly assigned to treatment and received >=1 dose of Double-Blind study treatment.|
754192|NCT00441363|The study was originally designed to enroll 326 subjects in order to randomize 225 subjects. Due to a strategic business decision of the former sponsor (PLIVA), enrollment into the study was prematurely terminated.|
754193|NCT00441337|Study from 25 October 2006 to 27 November 2009. After completion of a single dose (cycle 1), those meeting criteria could be re-treated with 2 additional doses (cycle 2); and additional cycles. Participants who had a complete response (CR) or partial response (PR) at end of re-treatment were followed-up until disease progression for 2 years.|39 participants were enrolled and 39 were treated with at least 1 dose or a partial dose of study drug.
754194|NCT00441285|This protocol (2 groups, n=180) was modified by the DSMB to add a pharmacokinetics / safety substudy (two groups, n=32). After the substudy results were available, we were approved to proceed with a modified study design (3 groups, n=240). This second study was terminated after enroling patient 124 because of early efficacy (total n= 132+24, 156)|
754195|NCT00441272|Recruitment will occur in Clinic 8 of the Clinical Center. We anticipate needing to screen 100 subjects to identify a sufficient number to enroll in the study. Recruitment will be over approximately 1 year.|
754196|NCT00441259|Participants were enrolled and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India.|A total of 96 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
754197|NCT00441168|Subjects were recruited from 05 December 2006 to 04 July 2007 at 2 sites in Germany, 1 site in Hungary, 3 sites in Lithuania, 3 sites in Poland and 3 sites in Russia|Subjects who qualified were screened. Subjects were considered for eligibility when the investigator would treat the subject with a combination therapy of vincristine, adriamycin and dexamethasone (VAD) standard therapy. One subject was not randomised because the subject was a screening failure.
754198|NCT00441142||Although 119 pts were registered & enrolled to trial, only 111 began study tx (8 enrolled pts did not receive tx on study). 7 pts randomized to Ph II Arm A removed their consent before starting study tx, and 1 Ph II Arm B pt was removed from study before starting tx, as pt clinically declined immediately following registration/randomization.
754199|NCT00441129||
754200|NCT00441116||
754201|NCT00441103|Date of first participant first visit: 15 Dec 2006. Date of last participant last visit: 28 Nov 2008. Twenty five trial centers enrolled participants in the following countries: Bulgaria (7), Canada(2), Estonia (2), Germany (1), Italy(2), Lithuania (1), Romania (1), Russian Federation (4), Serbia (2), and Spain (3).|Participants meeting the eligibility criteria during screening period of up to 14 days were randomly assigned in a 2:1 ratio to receive either Rebif® New Formulation or matching placebo for 16 weeks. There were 33 screening failures: participants who did not meet all eligibility criteria (n=29), withdrawal of consent (n=3), and lost of view (n=1).
754202|NCT00441090||
754203|NCT00441064|A total of 132 patients were randomly assigned to one of the two diet sequences: 69 in the low/high and 63 in the high/low diet sequence. After 4 wks on the assigned diet, patients were then crossed over to the other diet. Patients who were on a high sodium diet for the first 4 wks started on a low sodium diet for the next 4 wks vice versa.|Safety Population (SP) -Included all randomized patients who received at least 1 dose of study medication. Intent-to-treat population (ITT) -All randomized patients who received at least 1 dose of study medication and had at least 1 valid post baseline assessment of primary efficacy variable.
754204|NCT00441012|"06-Dec-2006 (First Participant Enrolled in Study) to 03-Jun-2008 (Last Participant had their Last Visit).
~This study was conducted at 27 sites: 17 in Canada (16 of which were active sites) and 10 in Finland."|Participants excluded for history of or prior vaccination for hepatitis B (Hep B) or Haemophilus influenzae Type B (Hib) disease and for administration of blood products. Participants also excluded if mother received Hep B, Hib vaccine, or blood products 6 months prior to participant birth.
754271|NCT00437398|Subjects were recruited from the Mayo Clinic in Rochester, Minnesota.|Three subjects were screened for islet transplantation; one subject was ineligible, being Epstein-Barr virus (EBV) seronegative.
754205|NCT00440947|Participants (PAR) were recruited at 66 centers in the United States of America and Canada. HIV-RNA, human immunodeficiency virus-ribonucleic acid; ml, milliliters.|The study had a 36-week Non-randomized Induction Phase, followed by an 84-week Randomized Phase. All PAR completing 84 weeks were eligible to enter an optional 60-week extension phase (EP); some PAR chose not to continue in the EP. PAR whose HIV-RNA wasn't <50 copies/ml before Week 36 weren't allowed to randomize at Week 36 and were withdrawn.
754206|NCT00440830|This prospective, double-blind trial was approved by the IRB at Columbia University Medical Center. All patients signed written informed consent before surgery.|
754207|NCT00440726|31 unique individual participants were enrolled into the study collectively for both Phase 1 and 2. The breakdown is as follows: 10 in the Phase I study and 21 in the Phase II study. There was, however, one patient that started on Phase I, Cohort 2 that was later eligible and rolled into the Phase II study.|
754208|NCT00440700||
754209|NCT00440596|248 Assessed for eligibility 192 excluded|181 did not meet inclusion criteria 11 did not consent to participate
754210|NCT00440557|The study was initiated 29 August 2006 and completed on 21 February 2008. Subjects were screened for eligibility at 64 investigative sites within the U.S. Three hundred seventy-five subjects (intent to treat) were randomly assigned to a treatment group by 52 investigators from 56 sites. Safety population consisted of 373 subjects.|
754211|NCT00440531|27-Nov-2006 (First Participant Enrolled in Study) to 26-Nov-2007 (Last Participant had their Last Visit). This study was conducted at 22 sites: 10 in Canada, 2 in Denmark, 5 in Sweden, and 5 in the United Kingdom.|In the Modified Process group, 2 participants were randomized but not vaccinated: 1 participant withdrew consent, and 1 participant had an SAE (Serious Adverse Experience) of hypertension prior to vaccination.
754212|NCT00440518|A multicenter trial with 24 sites with enrolled subjects and 23 sites with randomized subjects from 15 Feb 2007 to 17 Jul 2008.|Subjects on stable dose of prophylactic medication entered a 2-week Wash-Out Period followed by a 4-week Baseline Period without any prophylactic medication. Subjects not taking prophylactic medication entered the Baseline Period directly for 6 weeks. Subjects entered a 3-week Titration Period and if completed entered a 14-week Maintenance Period.
754213|NCT00440505|This double-blind prospective study was approved by the Institutional Review Board of Columbia University Medical Center. Written consent was obtained from all subjects. Women presenting with chronic pelvic pain to a gynecologist or to the pain clinic at New York Presbyterian Hospital were eligible for inclusion.|Twenty-six women were recruited for the study. Six women declined to participate after consenting but before commencing treatment; these women are not included in the analysis.
754214|NCT00440466||
754215|NCT00440401||From the total of 120 enrolled subjects, data are presented for 119 randomised subjects that received trial treatment (= Intention to Treat (ITT) population).
754216|NCT00440310||
754217|NCT00440297|22-Dec-2006 (First Patient Enrolled in Study) to 05-May-2008 (Last Participant had their Last Visit). This study was conducted at 23 sites: 7 in Canada, 8 in the United Kingdom, 5 in Italy, and 3 in Spain. In the Modified Process group, one participant was randomized by mistake, and therefore was not vaccinated.|A screening serum sample was obtained prior to study entry and assayed for hepatitis B serologic markers. Only patients that were seronegative were considered for enrollment.
754218|NCT00440271||
754219|NCT00440232|Eligible participants were recruited from our office practice or surrounding community from 7/16/07 through 3/18/09|
754220|NCT00440193|Participants with confirmed acute proximal symptomatic deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE) were recruited at specialized study sites.|Out of 3459 participants screened, 10 failed screening due to protocol violations, and 3449 participants were randomized (1731 to rivaroxaban and 1718 to enoxaparin/VKA).
754221|NCT00440180||
754222|NCT00440115||"Smokers screened for eligibility (n=1827)
~Ineligible (n=714)
~Invited to participate (n=1113)
~Declined to participate (n=305) Unable to contact (n=58)
~Randomly assigned (n=750)"
754223|NCT00440050|Subjects were recruited at 51 sites in the United States between February and November 2007.|Out of 555 subjects screened, 402 met the study criteria and were randomized.
754224|NCT00440037|Subjects who had completed any previous romiplostim ITP study in Japan (Studies 20050162/NCT00305435 or 20060216/NCT00603642) were eligible to screen for this study. The study began in October 2006 and continued until romiplostim was commercially available in Japan.|
754225|NCT00440011||
754226|NCT00439946|Screening was initiated by investigators at participating study sites 7 to 28 days prior to the Baseline visit. The first subject was enrolled on February 20, 2007 and the last subject completed the study on September 30, 2009. After an extended recruitment period during which no new subjects were enrolled, the study was closed in 2011.|A total of ten subjects were screened. Eight were enrolled and completed the study. One subject withdrew their consent prior to enrolling. The second subject failed screening due to low hemoglobin levels. Once enrolled, baseline assessments were completed, and patients underwent rapid switch from epoprostenol to treprostinil infusion.
754227|NCT00439777|Participants with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT) were recruited at specialized study sites.|Out of 4843 participants screened, 10 failed screening (6 due to protocol violations, 2 due to investigator decision and another 2 subjects due to technical problems [interactive voice response system did not work properly]). 4833 participants were randomized (2420 to rivaroxaban and 2413 to enoxaparin/VKA).
754228|NCT00439738||
754229|NCT00439725|Participants with confirmed symptomatic deep vein thrombosis or pulmonary embolism, who either had been treated for 6 or 12 months with warfarin or acenocoumarol or rivaroxaban in study NCT00440193, or who had been treated for 6 to 14 months with warfarin or acenocoumarol outside study NCT00440193, were recruited at specialized study sites.|Out of 1200 participants screened, 3 failed screening (2 due to withdrawal of consent and 1 due to a protocol violation), and 1197 participants were randomized (602 to rivaroxaban and 595 to placebo).
754230|NCT00439673||
754231|NCT00439647||
754232|NCT00439608|60 patients were enrolled at multiple hospitals and medical clinics|
754272|NCT00437294||Participant flow reports those participants who discontinued from study drug.
754273|NCT00437281||Participants who completed this study and who tolerated study medication were eligible to enroll in study A0081075 (NCT00448916), a 12-month open-label extension study of pregabalin.
754233|NCT00439569|The protocol was open for recruitment between January 31, 2007 and September 23, 2008 at neurology clinics affiliated with university hospitals.|Pre-specified dosage levels of sodium phenylbutyrate (NaPB) were calculated using the modified Fibonacci rule yielding dosage levels of 500, 675, 900 and 1200 mg /kg/day. The selection of 500 mg/kg/day as the initial dosage was based on the recommended dosage of 450 -600 mg/kg/day for the approved indication for urea cycle disorders in children.
754234|NCT00439556|Patients enrolled at MD Anderson clinic from February 2007 through May 2011.|
754235|NCT00439517|First subject randomised 12 February 2007, last subject randomised 30 June 2008. Cut off date was 30th June 2009|A total of 329 participants were screened and 302 participants were included in the Intent to Treat (ITT) Population. One patient included in the ITT population received no study medication and was not included in the Safety Population which comprised 301 participants (151 received UFOX plus cetuximab and 150 FOLFOX4 plus cetuximab).
754236|NCT00439465||
754237|NCT00439413||
754238|NCT00439374|From April 2007 through May 2011, the fourteen centers of the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development participated in this randomized double-blind placebo-controlled trial. Eligible women were offered participation.|"Women who signed informed consent received a compliance injection of the placebo and were asked to return at least 3 days later for randomization. If a woman did not return for a randomization visit before 23 weeks 0 days of gestation, she was excluded."
754239|NCT00439335|Healthy ambulatory adults were recruited from the surrounding community of the research clinic from March 14, 2007 to June 20, 2007.|
754240|NCT00439309|Subjects enrolled between 6APR07 & 20MAY08 at: U. Hospitals of Cleveland; Cleveland Clinic; Medical U. of Ohio Toledo; Boston Medical Center; OHSU; Southern Illinois U.; Washington Hospital Center; Penn State Heart & Vascular Inst., Georgetown U.; Brigham & Women's; Methodist Hospital; Vascular & Transplant Specialists; St. Vincent's East|
754241|NCT00439296||
754242|NCT00439270||A total of 49 participants were enrolled in the study, and 46 entered the treatment period and received at least 1 dose of dasatinib.
754243|NCT00439244||
754244|NCT00439231||
754245|NCT00439218|The protocol was open for recruitment between January 31, 2007 and April 2, 2009 at neurology clinics affiliated with university hospitals.|Pre-specified dosage levels of sodium phenylbutyrate(NaPB) were calculated using the modified Fibonacci rule yielding the dosage levels of 500, 675, 900 and 1200 mg /kg/day. The selection of 500 mg/kg/day as the initial dosage was based on the recommended dosage of 450 -600 mg/kg/day for the approved indication for urea cycle disorders in children.
754246|NCT00439179|Patients with both pancreatic and bilary cancer were enrolled|
754247|NCT00439140||Botulinum toxin Type A 300U was discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) received botulinum toxin Type A 200U instead.
754248|NCT00438971|Outpatients 18-75 years of age with a current DSM-IV diagnosis of panic disorder with or without agoraphobia were recruited through hospital and media advertisement between August 2006 and April 2008.|Subjects were required to be free of all psychiatric medications except for benzodiazepines initiated at least 2 weeks prior to study initiation and with the dose held stable during the trial. Of the 17 individuals initially enrolled, 2 completed the screening procedure but did not initiate pharmacotherapy and are not included in analyses.
754249|NCT00438932|16 patients completed the full study. Patients were recruited from renal clinics.|There was no wash-out, run in or transition.
754250|NCT00438880|Phase I of this study opened 10/20/2004 and accrued 30 patients before closing 10/29/2007. Eight patients were accrued to the Phase II portion at the maximum tolerated dose established in Phase I.|
754251|NCT00438854|Started recruitment 12/2006 and ended recruitment 12/2008. Patients were recruited from the clinics of the Massachusetts General Hospital and the Dana Farber Cancer Institute.|Patients signing the consent form were screened for eligibility. If eligible, they were started on protocol. This is a single-arm protocol.
754252|NCT00438815||
754253|NCT00438802||
754254|NCT00438750||
754255|NCT00438672||
754256|NCT00438659|Total of 176 patients were enrolled on this trial between 9/21/07 and 12/07/2007. There were 7 cancels (5 in Arm A and 2 in Arm B) and 3 patients discontinued treatment (1 in Arm A and 2 in Arm B). In total 84 in Arm A and 82 in Arm B were evaluable for the primary endpoint.|
754257|NCT00438633||
754258|NCT00438490||
754259|NCT00438464|Recruitment period: From 2007 to 2012 recruitment was done at various medical clinic locations.|Of the 210 participants recruited, 204 were randomized to the study.
754260|NCT00438451|"43 study centres in three countries participated in this study (31 in Germany, 5 in Austria, 7 in Switzerland). The number of patients recruited in each country (242 Germany, 55 Austria, 29 Switzerland) and per centre (range from 1 to 53) was heterogeneous.
~Therefore, centre effects were explored by pooling the centres with less than 20 subjects."|In total, 361 patients were randomized. 359 patients were analysed ITT (patient 0213 did not suffer from epilepsy, patient 3604 should not have been asked for informed consent, because of his legal guardianship).
754261|NCT00438399|Patients were enrolled in 18 centres in Italy, Spain, United Kingdom and Germany between 19 February 2007 until 22 January 2008|219 participants recruited.
754262|NCT00438360||
754263|NCT00438256||
754264|NCT00438204||
754265|NCT00438191||
754266|NCT00438100||
754267|NCT00437983|Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.|
754268|NCT00437658|Participants were randomized at 58 centers in the United States.|This study consisted of a 24-week treatment period and a 24-week post-treatment period. Participants were randomized in a 1:1:1 ratio to one of three treatment groups.
754269|NCT00437645||
754270|NCT00437489|Five centers in the Philippines, 2 centers in Singapore, 1 center in Hong Kong, and 1 center in Pakistan enrolled subjects.|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study before it had recruited targeted number of subjects and followed them for the per protocol specified period.
754279|NCT00436982|The recruitment period was from February to November 2006. In a single centre patients were prospectively randomised to receive either a cemented Triathlon total knee system or a Duracon total knee system. Randomisation with envelopes, 30 patients in each group. Only one knee per participant was enrolled for the study.|
754280|NCT00436969|Enrollment occurred between January 2007 and February 2010 at 13 sites based in the US.|Four subjects were randomized; however due to required imaging inclusion/exclusion criteria was not met. Hence, these 4 subjects were not treated.
754281|NCT00436956||
754282|NCT00436917|Sixty participants were recruited between June 2006 and July 2007 at 6 individual sites participating in the Mayo Clinic Cancer Research Consortium (MCCRC).|
754283|NCT00436904||
754284|NCT00436852||
754285|NCT00436826||Initially 42 participants randomized under original protocol but enrollment terminated because of hematological toxicities. Protocol amendment 1 and 2 were implemented and enrolled 172 participants. Protocol amendment 5 was generated, resulting in discontinuation of Cladribine and reduction of Extension period and Safety Follow up to 48 weeks.
754286|NCT00436748|This trial enrolled pediatric patients with chronic kidney disease (CKD) who were anemic and not treated with an erythropoiesis-stimulating agent (ESA). The study was conducted at 43 centers in the US, Europe and Mexico. The first participant was enrolled on 16 September 2008 and the last participant was enrolled on 02 December 2013.|A total of 189 participants were screened, 116 participants were enrolled, and 73 screen failed. The primary reasons for screen failure were hemoglobin concentration > 10 g/dL or transferrin saturation < 20%. Randomization was stratified by age and dialysis status.
754287|NCT00436644|Eighteen patients were enrolled in stage 1 from February 2, 2007 to May 9, 2008.|
754288|NCT00436618|277 patients were accrued from 4 medical clinics in the United States between August 2005 and May 2010. One patient withdrew before starting treatment and thus excluded from the results.|
754289|NCT00436605||
754290|NCT00436566|One-hundred and twenty-two (122) participants were recruited between April 2007 and October 2008 at Mayo Clinic. Ten (10) participants were deemed ineligible due to HER-2+ not corroborated by the central laboratory evaluation. These 10 participants and 3 participants (those who did not completed the treatment) were excluded from all analysis.|
754291|NCT00436553||
754292|NCT00436501|Recruitment Period: January 18, 2007 to September 27, 2010. All recruitment done in medical clinic settings.|Of 58 total participants enrolled at multiple sites, three in the Phase II portion of the study were excluded from the trial.
754293|NCT00436475||
754294|NCT00436436||
754295|NCT00436345||
754296|NCT00436332||
754297|NCT00436280||Reasons reported are for discontinuation from study treatment.
754298|NCT00436215||
754299|NCT00436163||
754300|NCT00436046|Healthy ambulatory adults were recruited from the surrounding community of the research clinic from March 16, 2007 through March 21, 2007.|
754301|NCT00436007||The study comprised a vaccination phase (Months 0-8) and a follow-up phase (Months 8-19). The Stamaril™ vaccine was not part of the EPI Tanzanian vaccination schedule at study planning. Hence this vaccine was not administered to subjects from Tanzania.
754302|NCT00435994||
754303|NCT00435942|Subjects screened and enrolled at 29 sites in the United States|
754304|NCT00435929|The study was conducted from 12 September 2006 to 09 April 2009 at 3 sites in US and 2 in Canada.|Total 19 participants were screened. A total 9 participants with HIV infection with moderate liver disease (Group 2) and 7 participants with HIV infection with normal liver function (Group 1) were enrolled in the study. Participants in Group 1 were matched with those in Group 2 on the basis of age, gender, weight, and tobacco use.
754305|NCT00435825||
754306|NCT00435812||
754307|NCT00435591||
754308|NCT00435539|The first patient was enrolled on 2 March 2007 and the last patient completed the last visit on 8 January 2009. All patients were selected in medical clinics|All subjects in all cohorts had a similar follow-up schedule to the day 28 post-injection visit. After day 28, non-responders in cohort 4 received up to 2 repeated injections and thus had a different study follow-up schedule than all other subjects.
754309|NCT00435487|Subjects participated in the study between 22 June 2007 and 30 December 2008.|
754310|NCT00435461|The study included 5-21 days of screening period followed by two weeks of treatment period and a Follow-up. Participants had to meet five symptom assessment criteria before randomization. Two of these were based on average Nasal Symptom Score assessment and three criteria's were based on the Daytime reflective Nasal Symptom Score (D-rTNSS).|Total of 1360 participants were planned for enrollment so as to have 951 evaluable participants. A total of 1338 participants were screened and 936 were randomized.
754311|NCT00435409||
754312|NCT00435370|The recruitment period began in May 2006 and ended in April 2011. Participants were approached for participation in this study after being hospitalized for at least 2 weeks if they were schizophrenic and capable of providing written informed consent.|After signing informed consent for participation in the study, subjects were interviewed by study doctor and all medical and psychiatric data were reviewed prior to admitting the subject and beginning medication.
754313|NCT00435188||
754314|NCT00435162|At period 1, participants were randomized (2:1:2) to Valsartan 0.25 mg/kg, 1.0 mg/kg or 4.0 mg/kg. At period 2, participants were randomized (1:1) to either stay on Valsartan or switch to placebo.|
754315|NCT00435045||
754316|NCT00435019|A total of 35 centres in 11 countries.|
754317|NCT00434993|The trial was conducted with a combined Phase II/III design to enroll 1000 patients with a safety review performed after 100 subjects were enrolled and interim analysis looks at 250, 500, and 700 subjects. The first subject was entered in August 2007 and the last subject in July of 2008 when the study was stopped for futility at 282 enrolled.|
754318|NCT00434967|Following a screening evaluation, patients underwent a 4-week, single-blind treatment with placebo, after which eligible patients were randomly allocated in a 5:5:5:1 ratio to receive 8 weeks of double-blind treatment either with candesartan/Hydrochlorothiazide (HCT) 32/25 mg or candesartan 32 mg or HCT 25 mg or placebo, respectively.|In total, 2207 patients were enrolled in the study at 128 centres in 10 countries, 1772 patients received run in medication and 1524 patients were subsequently randomised to double-blind treatment.
754319|NCT00434954||Patients treated with metformin (MET only;confirmatory population used for primary analysis) and additional patients treated with metformin plus either sulfonylurea or meglitinide (MET+SU; exploratory population) were enrolled at a 3:1 ratio; metformin was continued.Within each population, patients were then randomly assigned 1:1 to study treatment
754320|NCT00434876|Addiction psychiatry clinic, behavioral health laboratory, and self referrals solicited through flyers.|
754321|NCT00434759||
754322|NCT00434642||
754323|NCT00434590||
754324|NCT00434577||Out of 715 subjects enrolled, only 714 were vaccinated.
754325|NCT00434512||A total of 229 subjects were enrolled and screened in this study, and 49 of these were excluded before vaccination.
754326|NCT00434434||
754327|NCT00434421|The result tables represent the safety population: all subjects that initiated the 1-day, 8-dose escalation, otherwise referred to as the Preliminary Dosing Visit. One subject in the 8-17 age group withdrew from the study after this timepoint and was replaced with another participant.|
754328|NCT00434356||
754329|NCT00434330||
754330|NCT00434304||
754331|NCT00434278||
754332|NCT00434252||
754333|NCT00434226||
754334|NCT00434213||
754335|NCT00434161||
754336|NCT00434148|The enrollment number reflects the participants who were randomized and received at least one dose of drug.|A total of 165 participants were randomized, but 1 participant from the 600ug group and 2 participants from the 900ug group were not treated. Participants who completed month 12 and did not enter the extension phase were not counted as discontinuations.
754337|NCT00434122||
754338|NCT00434109|All patients seen at Moffitt Cancer Center with hepatic metastases from gastrointestinal neuroendocrine tumors were screened for eligibility to be enrolled in the study.|
754339|NCT00434057||
754340|NCT00434018|Recruitment intervals at each site were as follows: 4/08-8/10 at Tampa, 6/08-8/10 at Boston, and 11/08-10/09 at Augusta. Recruitment efforts included posters in VA elevators and in clinic waiting rooms, study brochures, and/or referral of subject by primary care physicians.|
754341|NCT00433992||
754342|NCT00433966|Between March 25, 2005, and May 7, 2007, 3602 patients with STEMI undergoing primary percutaneous coronary intervention were enrolled at 123 academic or community-based medical centers in 11 countries.|Random, open-label assignment (1:1 ratio) to unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor or bivalirudin alone. After emergency angiography and triage to PCI, CABG, or GDMT, eligible patients were randomly assigned (3:1 ratio) to either paclitaxel-eluting stents or uncoated, bare-metal stents.
754343|NCT00433914|Subjects were enrolled at one study center in the United Kingdom (UK).|All enrolled subjects were included in the trial.
754344|NCT00433836||
754345|NCT00433771|Enrollment complete|
754346|NCT00433745||
754347|NCT00433654|The first implant occurred 5 February 2007. A total of 484 subjects were enrolled, including 113 enrollments at 13 centers in the US and 371 enrollments at 29 centers outside of the US.|Implant procedure included EnRhythm MRI SureScan pacemaker and 2 CapsureFix MRI 5086MRI leads. Pacemaker function and adverse events were assessed. 17 subjects did not have an implant attempt. 3 subjects received a subset of the 3 system components and were followed for safety. All other subjects were randomized after successful implant.
754348|NCT00433550||Prior to registration, patients were tested for UGT1A1 TA indel genotype of 6/6, 6/7, or 7/7. Patients were grouped into one of three treatment groups depending on UGT1A1 genotype. All other genotypes were ineligible. The endpoints of this study are not to compare results between the UGT1A1 types, but to analyze as one combined cohort.
754349|NCT00433537||
754350|NCT00433511|Accrual to Step 1 of E5103 was activated November 2, 2007 and closed February 28, 2011; 4994 patients were entered. Upon unblinding of Step 1 treatment assignment, only patients treated on Arm C during Step 1 who had not ended protocol treatment early were eligible to register to Step 2 (Arm D) and 1316 patients were enrolled to Step 2.|
754351|NCT00433446||
754352|NCT00433381||
754353|NCT00433329|The study was conducted at 23 centers in the United States. First patient, first visit: 25 April 2007; last patient, last visit: 23 April 2010|The study included a screening phase of 2 weeks.
754354|NCT00433290||
754355|NCT00433199|Subjects were recruited in 63 centers in US from February 2007 to April 2007 in clinics. The study was designed with a double-blind period of 182 days on Placebo or Androgel 1.62% followed by an 182 days open-label period on Androgel 1.62%.|All subjects started at a daily dose of 2.50 g testosterone gel 1.62% or matching placebo on Day 1. Within 2 days of each of visits (D14, D28 and D42), the dose was titrated up or down in 1.25 g steps if necessary, based on pre-specified normal range criteria, by an unblinded reviewer. The minimum and maximum daily doses were 1.25 g and 5.0 g.
754356|NCT00433160||Results from 4 patients aren't included in baseline and outcomes: 3 (2 placebo and 1 teriparatide) didn't receive study drug; 1 (placebo) had a significant good clinical practice issue of receiving study drug assigned to another patient.
754357|NCT00433147||Participants were screened for evaluation of eligibility to participate in the study. Confirmatory β-glucosidase genotype testing was done at screening to confirm reported genotype. Thirty participants received at least 1 dose of study drug. All participants were eligible for inclusion in the safety and 29 in the pharmacodynamics (PD) populations.
754358|NCT00433017||
754359|NCT00433004||
754360|NCT00432991||
754361|NCT00432965||
754362|NCT00432835|Patients seeking temporary gastric electric stimulator devices for drug-refractory gastroparesis between August 2005 and October 2006 who met the inclusion criteria and did not have any of the exclusion criteria were offered access to the research protocol.|No significant events or approaches for the overall study following participant enrollment were performed prior to group assignment.
754363|NCT00432809|Study recruitment began December 2006 and the last patient was enrolled January 2011. Patients were recruited from the Bariatric and Diabetes Outpatient clinic.|68 patients screened fail prior to randomization due to not meeting inclusion criteria.
754364|NCT00432744||
754724|NCT00413582|Patients were recruited from patients undergoing pectus excavatum repair.|All patients who consented were enrolled
754365|NCT00432679|From 19 April 2006 to 28 March 2007, total of 149 participants were randomized at 22 centers in Japan.|Out of 172 participants given consent to participate in the study, 23 participants were withdrawn from the study before randomization.
754366|NCT00432666||
754367|NCT00432601||
754368|NCT00432562|"STUDIED PERIOD:
~First Patient Enrolled: 22 March 2007 Last Patient Completed: 02 November 2007 Study patients were enrolled at seven study sites in Argentina."|Pre-screening data was not collected for this study
754369|NCT00432458|Sixty-eight (68) participants were recruited at Mayo Clinic (Rochester) and Memorial Sloan-Kettering between July 2003 and March 2009.|All 68 participants were randomized.
754370|NCT00432445|Recruitment Period: All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Study closed early due to low accrual, few eligible participants.
754371|NCT00432380||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
754372|NCT00432341||
754373|NCT00432276|Participants took part in the study at 235 investigative sites in 16 countries worldwide from 30 January 2007 to 5 June 2009.|Participants with a diagnosis of type 2 diabetes who were experiencing inadequate glycemic control on their existing treatment regimen of metformin HCl plus pioglitazone were randomized in a 1:1 ratio to 1 of 2 treatment arms: addition of alogliptin 25 mg versus titration of pioglitazone 30 mg to 45 mg.
754374|NCT00432237|There were 83 centers worldwide that participated: United States (36), Latin America (9), and Europe (38). First Patient Treated = 25 March 2007, and Last Patient Last Treatment = 29 November 2007.|Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.
754375|NCT00432172||
754376|NCT00432159|First subject was enrolled on July 10, 2006. The final study subjects were enrolled on March 22, 2011 and all study sites were informed that enrollment was closed effective March 31, 2011.|
754377|NCT00432042|A total of 963 participants were screened at study centers in Italy and Germany.|
754378|NCT00431964||
754379|NCT00431951|This study was conducted at one site, Orlando Clinical Research Center, Orlando, FL. The study was conducted in healthy volunteers from the site's database.|After a 28-day screening and 1-day enrollment period, study drug was administered on Day 1. Ten participants (8 drug:2 placebo) were randomized in each of three dosing groups (250, 400, and 800 mg ST-246). Each group was divided into 2 cohorts of 5 subjects (4 drug:1 placebo), with one cohort receiving drug 4-8 weeks before the other cohort.
754380|NCT00431847|Six hundred eighty-seven (687) combat-injured military service members hospitalized with at least one major limb injury were assessed for eligibility as an inpatient at one of two military treatment facilities. Three hundred one (301) of these patients did not meet criteria for study enrollment.|Three hundred eighty-six (386) participants provided study data. Twenty-Eight (28) of these participants were excluded from group observation due to completion of less than two study visits.
754381|NCT00431834|A total of 91 subjects were consented to the study, of which 75 subjects received study treatment at 14 of the 15 investigational centers in the United States. The first subject was enrolled on May 22, 2007 and last patient enrolled on February 19, 2010.|No additional wash out, run-in, or transition was utilized during this study.
754382|NCT00431626||
754383|NCT00431496|Participants were enrolled from 27 October 2006 through 31 December 2008|
754384|NCT00431444||
754385|NCT00431184||
754386|NCT00431132|40 sites in Czech Republic, Denmark, Finland, France, Hungary, Norway, and Sweden|
754387|NCT00431067||
754388|NCT00431041||
754389|NCT00430989||
754390|NCT00430950|"92 principal investigators screened patients at clinical sites in Europe (8 in Belgium, 17 in Germany, 12 in the Netherlands, 17 in Poland, 19 in Russia, 10 in Slovakia, and 9 in the Ukraine).Sites were either hospitals or general practitioners.
~First patient in: 05 December 2006 Last patient out: 07 May 2008"|Trial is 2 week taper-off phase and 2 treatment periods. Period I - 8-week open-label OM 40mg. Only non-responders eligible to randomise into Period II. Period II - 8-week double-blind patients assigned into one of two arms. Results provided for Period II only.
754391|NCT00430937|194 participants were randomized; 5 participants were not exposed to study drug by mistake; therefore, only 189 participants received study drug.|
754392|NCT00430781|Participants (par.) continued to be enrolled into all three treatment arms after clinical data cutoff for the interim analysis, but before the results were evaluated. Final total enrollment was 228 participants: 76 in the combination arm, 78 in the lapatinib monotherapy arm, and 74 in the pazopanib monotherapy arm.|Study was initially designed and started as a randomized, three-arm, controlled trial. Participants were randomized to the combination of pazopanib plus lapatinib, pazopanib monotherapy, or lapatinib monotherapy. Based on results from a planned interim analysis, the combination group was terminated, but the monotherapy groups continued as planned.
754393|NCT00430768|Subjects were recruited to the University of Florida, Clinical Research Center for the active study; long term follow up was completed at the University of Massachusetts, Medical School.|Subjects on alpha-1 antitrypsin (AAT) protein replacement product prior to study, discontinued treatment 4 weeks (Group 1) and 8 weeks (Groups 2 and 3) prior to study agent administration and were able to resume treatment 11 weeks after study agent had been administered. The group was determined by when the subject joined the study.
754394|NCT00430755|Patients who were interviewed had been admitted emergently. Patient charts were not consulted prior to any interview; and the study nurse, who picked patients randomly for interview, had no knowledge of these patients before an interview and carried on no discussions with floor staff about a patient's clinical state.|Acquisition of clinical data in the history-taking program is based on the principles of pathophysiology formalized as software algorithms representing medical knowledge as branched chain decision trees.
754395|NCT00430716||
754396|NCT00430677||423 participants were enrolled and screened; 300 were randomized. Of the 228 participants who completed the short-term period, 211 received treatment in the long-term extension period. A total of 166 participants (78.7%) remained in the study at the time of study termination by the sponsor.
754426|NCT00429143|Patients presenting to Thomas Jefferson University with hematological malignancies requiring hematopoeitic stem cell transplantation without matched related donors. Opened January, 2006 through August, 2009|
754397|NCT00430638|Subjects were recruited at 29 US sites (private medical practices and small clinics) over 5 months from December 2006 to May 2007 from each physician's clientele base. About 450 potential subjects were to be screened so that about 250 eligible subjects, men and women at least 18 years of age with stage I or II hypertension, were randomized.|After 3-4 weeks of placebo treatment, eligible subjects were randomized. 140 were randomized to drug; 138 to placebo. 2 active drug participants were given the wrong dose at entry. Because only 138 participants received Olmesartan 20 mg, any demography data totals are equal to 276 instead of 278. The subgroup analyses are similarly affected.
754398|NCT00430625|Type 1 Gaucher disease patients (pts) >2 years. The first patient (pt) consented to participate in the study on 11 January 2007 and the last patient enrolled on 04 April 2008.|Gaucher disease-related anemia and at least 1 of the following: moderate splenomegaly, thrombocytopenia or palpable enlarged liver. Patients were not to have received any treatment for Gaucher disease within 30 months of study entry. Patients randomized to receive VPRIV®(45 or 60 U/kg)every other week by intravenous (IV) infusion.
754399|NCT00430573|This pilot study was terminated due to inadequate recruitment. The primary reason was unwillingness to take a study drug (a parent study that did not require randomized drug was likely a factor in this decision).|15 people consented to this study but 4 did not meet entry criteria and 1 was loss to follow-up before completing baseline evaluations. 10 participants were randomized and 5 dropped out before taking study drug.
754400|NCT00430521||
754401|NCT00430508|"78 investigative sites screened patients in Europe (19 in Czech Republic, 11 in Germany, 8 in Bulgaria, 5 in Spain, 20 in Ukraine, 1 in France and 14 in Poland).
~Sites were either hospitals or general practitioners. First patient in: 17 January 2007 Last patient out: 30 March 2008"|Trial is 2-week taper-off phase and 2 treatment periods. Period I-8-week open-label, OM 40mg. End of Period I, only non-responders randomised to Period II. Blood Pressure controlled patients discontinued. Period II-8-week double-blind four randomized treatment arms. Participant flow is Period II. 972 completed period I, 971 started period II.
754402|NCT00430495||A total of 456 subjects were screened, of whom 256 were enrolled and randomized of which 254 received the trial medication and included in Intention to Treat (ITT) population.
754403|NCT00430482|Participants were recruited via study flyers and postings or were referred to study staff by their substance abuse counselor.|133 individuals were consented. Eleven dropped out prior to SCID administration. At the intake visit, 27 individuals were deemed ineligible. Of the 95 individuals who were eligible, 17 dropped out prior to randomization (7 were discharged, 2 declined treatment, and 8 were lost to contact). A total of 78 individuals were randomized to treatment.
754404|NCT00430352||
754405|NCT00430300||
754406|NCT00430248|Subjects were enrolled at 324 sites in the United States from 16 February 2007 to 12 March 2008.|Subjects who were currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollemnt in once daily (QD) treatment groups.
754407|NCT00430183||
754408|NCT00430092|First subject enrolled January 24, 2007 and last subject completed September 20, 2007 at 11 sites in the United States.|"Subjects enrolled if, 24 hours after ocular surgery, they had an anterior chamber cell grade of ≥ 2 and met the protocol inclusion and exclusion criteria."
754409|NCT00430027|Between November 2006 and August 2008, 8 patients were enrolled in the study from the Radiation Oncology clinic.|This was to be a pilot/feasibility trial with a maximum of 15 patients enrolled, with the intent to propose a phase II trial. The study stopped before enrolling 15 patients, therefore the phase II trial was not pursued.
754410|NCT00429949||
754411|NCT00429923|First subject enrolled February 6, 2007 and last subject completed September 17, 2007 at 13 sites in the United States.|"Subjects enrolled if, 24 hours after ocular surgery, they had an anterior chamber cell grade of ≥ 2 and met the protocol inclusion and exclusion criteria."
754412|NCT00429858||
754413|NCT00429793|Patients were accrued to the first stage of accrual from 2/5/07 to 9/4/07. Patients were accrued to the second stage of accrual between 5/7/08 to 8/25/08. They received 25 mg IV of CCI-779 weekly. One cycle was 28 days.|Patients were required to have had one regimen of a platinum agent for the treatment of ovarian cancer. Patients entering the study therefore were required to have either persistent or recurrent cancer that was measurable by RECIST.
754414|NCT00429702|Recruitment took place at participating SunCoast CCOP Research Base affiliated CCOPs and MB-CCOP institutions. Potential subjects may be provided with a paper study brochure that included a brief study overview by study staff. No recruitment or dissemination of any study brochures or materials occured prior to each site obtaining IRB approval.|
754415|NCT00429663|Although 160 participants were enrolled into the study, only 156 were included in the participant flow because 2 were found ineligible after consent and 2 withdrew before fixation.|
754416|NCT00429572|Recruitment Period of January 1999 to December 2006. All participants were recruited at University of Texas MD Anderson Cancer Center.|
754417|NCT00429507|Recruitment period: March 7, 2007 to February 4, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
754418|NCT00429494|Recruitment period: November 18, 2002 to November 21, 2008. All participants were recruited in medical clinics.|Of the 60 participants enrolled, one participant was excluded prior to treatment due to ineligibility.
754419|NCT00429416||
754420|NCT00429403|Period of Recruitment: August 30, 2006 to August 25, 2009. All patient recruitment made at UT MD Anderson Cancer Center.|Study terminated early due to slow accrual.
754421|NCT00429364|From January 2007 through February 2011, a total of 21 clinical centers enrolled 608 participants into the study.|For subjects on prophylactic therapy with atenolol or other BB, ARB, ACEi, or calcium-channel blocker, before the study, the drug will be weaned over a 14-day period. After that, a drug washout period of 14-21 days will take place before baseline assessment and randomization.
754422|NCT00429299||Participants underwent core biopsy of the primary tumor, for the histological diagnosis and the biological characterization of the tumor. Radiological investigations were performed to rule out the metastatic disease. After diagnostic confirmation of the infiltrating carcinoma, participants were randomized to one of the three treatment arms.
754423|NCT00429273||"212 randomized (deemed eligible and enrolled). 71 randomized to Group 1: 3 dropped prior to receiving drug; thus 68 started drug.
~70 randomized to Group 2: 1 dropped before receiving drug; thus 69 started drug.
~71 randomized to Group 3:1 dropped before receiving drug; thus 70 started drug."
754428|NCT00429026|Enrollment Period: January 16, 2004 through March 29, 2006. All participants recruited at U.T. M.D. Anderson Cancer Center.|Only 5 patients received allogeneic stem cell transplantation while 35 received standard chemotherapy. Study terminated due to low patient accrual. This population was not analyzed by treatment arm on this study.
754429|NCT00428974||
754430|NCT00428948||Intent-to-treat population: All randomized participants.
754431|NCT00428922|September 2007 and November 2012|
754432|NCT00428844||
754433|NCT00428792||
754434|NCT00428714||Table presents reason for treatment discontinuation.
754435|NCT00428610||"The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have completed the trial if they experienced progressive disease or an adverse event."
754436|NCT00428597||
754437|NCT00428584|129 subjects were recruited from 27 Multiple Sclerosis (MS) Clinics in the US from December 2006 through August 2007.|Subjects had a pre-study evaluation period (screening) within 14 days of Study Day 1 which consisted of informed consent, medical/disease history, physical exam and laboratory assessments.
754438|NCT00428441|recruitment period 2007-2009 location Thrombosis centers|
754439|NCT00428389||
754440|NCT00428298||
754441|NCT00428246|169 patients screened from renal speciality clinics from November 2006 to June 2007|
754442|NCT00428220|In this open-label extension study, access to sunitinib was provided to participants who had participated in a previous parent study and who had been judged by the Investigator to have likely clinical benefit from continuing sunitinib dosing.|Participants receiving sunitinib in previous studies began treatment in this study with the last dose they were taking in the parent or extension study. Participants were to continue to access sunitinib on this protocol as long as there was evidence of disease control and/or clinical benefit in the judgment of the Investigator.
754443|NCT00428207|Around November 2006, patients were recruited through physician recommendations and also patient lists from clinic. Patients were sent letters asking them to be in the study. Study visits took place in the clinic.|This was a crossover study, so patients all began in one arm and were then switched to the other arm.
754444|NCT00428116|Infants were identified from Nairobi City Council clinics, the Kenyatta National Hospital (KNH) wards, and the HIV treatment clinic. Recruitment occurred from 2007-2009.|Of 140 infants enrolled, 37 infants died, 11 were lost, and 7 were withdrawn. Of 75 infants who completed 2 years ART pre-randomization, 33 were ineligible for randomization and 42 were randomized.
754445|NCT00428090|Participants (par.) were enrolled across 134 centres Austria, Bulgaria, Chile, China, Crotia, Estonia, Germany, Greece, Hungry, Korea, Mexico, New Zealand, Pakistan, Peru, Philippines, Puerto Rico, Russia, the United Kingdom and the United States from February 2007 to September 2008. The total study duration was 30 weeks (W).|Total of 639 par. were screened out of which 581 were randomized and 58 were placebo run-in failures. Analysis population included 579 par. of 581 randomized participants as 2 par. did not take study drug: 1 from placebo and 1 from donepezil arm.
754446|NCT00428077|Recruited from patient database in medical clinic.|
754447|NCT00427999|In 15 centers 72 patients were screened, 67 enrolled, of which 65 were treated and 33 completed the treatment phase. Intent to Treat (ITT) population included 61 patients. For the extension follow-up phase 19 patients were included in the safety analysis.|
754448|NCT00427973|The study enrolled the targeted 17 patients for the first stage between May 2009 and January 2010. Patients were recruited in the outpatient clinics.|
754449|NCT00427960|Participants were recruited from 25 primary and secondary care centres in the United Kingdom. The first participant was enrolled on 20th December 2006 and the last participant entered the study on 16th November 2007.|Participants entered an initial 6-week dietary run-in/ wash-out period, after which those with a fasting low density lipoprotein cholesterol (LDL-C) of greater than or equal to 4.00 mmol/L and triglycerides (TG) less than 4.52 mmol/L, were randomised to receive treatment with either rosuvastatin 5 mg plus atorvatstatin , or atorvastatin 10mg
754450|NCT00427934||
754451|NCT00427921||
754452|NCT00427908||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
754453|NCT00427895||Participants in Cohort 1 and 2 participated for 1 year in the study. Vaccination 2 (3 to 4 years after vaccination 1) was administered to participants in Cohort 1 and 2. Participants in Cohort 3 enrolled as part of amendment 3 participated for 6 months and participants in Cohort 3 enrolled as part of amendment 4 participated for 1 year in study.
754454|NCT00427804|Recruitment was conducted July 2007 to August 2008 at the Atlanta VA Medical Center.|Subjects included those with Crohn's disease and healthy controls.
754455|NCT00427791|Recruitment Period: July 05, 2005 to August 08, 2008. All participants were enrolled at UT MD Anderson Cancer Center.|
754456|NCT00427778|87 women were screened for eligibility between June 2006 and February 2008, at an academic specialty center|29 out of 87 were randomised. of those not randomized, 52 declined to participate and 6 did not meet inclusion criteria.
754457|NCT00427765|Recruitment Period: 2/4/2005 through 10/29/2010. All participant recruitment attempted at UT MD Anderson Cancer Center.|Among the participants enrolled, two were excluded from the trial before starting any treatment. There are two participants who were enrolled on the study twice (having to temporarily leave then re-enter the study).
754458|NCT00427700|Recruitment occurred between September 2008 and October 2009 at Hospital de Clínicas de Porto Alegre, a tertiary teaching hospital.|Women were excluded if they had elevated levels of thyroid-stimulating hormone, prolactin, or 17α-hydroxyprogesterone, if they had used oral contraceptives in the previous 2 months, or if they had a history of endometriosis.
754459|NCT00427661||
754460|NCT00427648|Two medical clinic sites were used between January 2007 and March 2011, initially the Evanston Continence Center (Evanston, IL), and subsequently to augment recruitment, North Shore Urogynecology (Lake Forest, IL, added July 2009).|no wash out, no run-in
754461|NCT00427635|Participants either full term or those with a gestational age or post-conceptual age ³28 to 44 weeks, and who were inpatients suspected of having the following clinical findings: any 2 (either individually or in any combination) of (1) apnea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second|
754462|NCT00427557|Recruitment Period: January 05, 2007 to November 05, 2010. All recruitment done at UT MD Anderson Cancer Center.|One participant of the 31 was enrolled but did not receive treatment.
754463|NCT00427349|This study was activated on September 16, 2008 and closed on March 18, 2010 with 46 patients registered to the study from 10 ECOG-ACRIN affiliated institutions.|
754464|NCT00427336|Recruitment Period: December 2000 to August 2009. All participants recruited at UT MD Anderson Cancer Center.|
754465|NCT00427297||
754466|NCT00427193||238 Participants were eligible, 18 participants withdrew prior to randomization, 220 participants were randomized to the study, and 2 participants withdrew prior to initiating the intervention.
754467|NCT00427037|Study subjects were recruited from Nephrology and Endocrinology clinics at Emory University School of Medicine|
754468|NCT00427011||
754469|NCT00426855|Twelve consecutive patients of a medical clinic were included in the trial.|
754470|NCT00426842|2008-2010|no subject was excluded from study participate prior to group assignment.
754471|NCT00426764||
754472|NCT00426751||
754473|NCT00426660||Of 2584 participants screened, 1047 participants were enrolled in the study.
754474|NCT00426556||Based on the results of the Phase I portion of this study, in addition to all available information on daily and weekly everolimus regimen in breast cancer and other tumors, all patients in the Phase II portion of the study were allocated to one arm to receive the recommended everolimus dose of 10 mg daily in combination with PT.
754475|NCT00426361||
754476|NCT00426283||
754477|NCT00426270||One participant was incorrectly enrolled in the study and was not included in the efficacy analyses but was included in the safety population.
754478|NCT00426231|This trial recruited lower income and lower educational level Black and white American patients identified at the time of hospitalization of the Johns Hopkins Medical Institutions for a myocardial infarction, coronary artery bypass graft, or percutaneous intervention.|Participants were enrolled during their hospitalization. Participants had their randomization visit at 1 month.
754479|NCT00426153|42 participants were enrolled at Mayo Clinic in Rochester, Minnesota from 1/1/2007 to 5/19/2008.|Following consent a tolerability test dose of 100 micrograms of short-acting octreotide was administered subcutaneously to subjects, followed by 4 hours of observation/vital signs. Randomized intramuscular dosing began the next day.
754480|NCT00426127||
754481|NCT00425945|Participants were recruited from the local community through the use of radio and print advertisements between January 31, 2007 and May 31, 2008.|Prior to randomization, participants were scheduled to complete two baseline visits three to seven days apart at the Stanford GCRC. Only those who successfully completed both baseline visits were randomized into the study.
754482|NCT00425854||
754483|NCT00425802|Protocol Open to Accrual 11/28/2006 Protocol Closed to Accrual 4/22/2014 Primary Completion Date 10/28/2016 Recruitment Location is the medical clinic|
754484|NCT00425750|This study was open to accrual from 8/25/2005 through 5/20/2008.|Twenty-seven patients consented, two of which were ineligible.
754485|NCT00425698|February 2007 until May 2009. Single recruitment site was the Hannover Medical School in Hannover, Germany|420 patients screened, 88 patients finally enrolled, other patients not enrolled because of age<18 years, living-related kidney transplantation, high pre-immunisation, multiple transplantation, participation in other studies, no interest for participation or withdraw of consent
754486|NCT00425672||
754487|NCT00425607|26 patients with classic HGPS from 16 countries were enrolled from May through October 2007 at Boston Children's Hospital. 2 additional patients had nonclassic mutations and are not included in the analyses.|One additional patient signed consent but withdrew from the protocol before receiving therapy.
754488|NCT00425503|Patients were recruited to participate in the study from 2004 to 2007 from oncology clinics associated with Baylor College of Medicine and affiliated hospitals in Houston, TX.|
754489|NCT00425477||
754490|NCT00425438||
754491|NCT00425386||The discrepancy between the number of participants enrolled (60) and the number of participants Started in the Participant Flow module (46) is due to screen failures and consent withdrawals.
754492|NCT00425373||
754493|NCT00425308|This is a prospective, national, multicenter, randomized, open label study, 12 months duration. Ten centers have been included with a study start October 2006 and end date May 2009.|
754494|NCT00425269|A multi-recruitment strategy included visits to mosques and other formal and informal gatherings in the local community, as well as word of mouth. Interested women came to an appointment at the local mother and baby health care centre where the intervention took place. An Urdu-speaking research assistant was in charge of the recruitment|
754495|NCT00425113|Pulmonary multidrug-resistant tuberculosis subjects were recruited from the National Masan Hospital, Masan, South Korea from 2009-2010.|
754496|NCT00425100|Subjects were enrolled at 59 centers (Belgium 5 centers, Costa Rica 2, Czech Republic 4, Germany 7, Republic of Korea 6, Poland 2, Slovakia 5, Ukraine 5, United States 23). Two centers in the United States did not randomize subjects.|595 subjects were screened. Responses to a 5-day bladder diary (during a 2-week screening period) identified subjects who met all other entry criteria for enrollment for study treatment.
754497|NCT00425061||This study had adaptive study design wherein participants were treated in 3 stages with higher number of participants enrolled in subsequent stages. As the treatment regimen was same for participants who received IMA-638 200 mg or placebo in Stage 2 and 3, participants were summarized together for these arms.
754498|NCT00424840||Treatment q21 day cycle, maximum of 6 cycles. Patients with CR, PR, SD continued on single agent bevacizumab 15 mb/kg q 3 weeks.
754499|NCT00424827|Between 2006 and 2011, twenty-six patients were screened and eleven of them were enrolled in the study. Most common reasons for screen failures were having resectable disease, metastatic disease or co-morbidity. Ten patients were able to tolerate and complete cycle 1 of chemoradiotherapy.|Most common reasons for screen failures were having resectable disease, metastatic disease or co-morbidity. A minority of patients present with localized disease. Surgical resection only hope for long-term survival. Locally advanced pancreatic cancer is defined as surgically unresectable, but has no evidence of distant metastases.
754500|NCT00424775|Date of first participant in: 26 January 2007. Data of last participant's last visit in study protocol: 7 March 2007. The study was conducted at single center in Japan.|"Vorinostat with Carboplatin and Paclitaxel were investigated in participants with chemotherapy-naive non-small cell lung cancer.
~Enroll 3 participants to dose level 1 of vorinostat and decide whether to enroll additional participants based on the Dose Limited Toxicity (DLT) manifestation.
~The starting dose of vorinostat was 300 mg once daily."
754501|NCT00424762|recruitment 2/05-10/06|
754502|NCT00424749|This study was done between June 2007 and July 2009. Participants were enrolled at the Mayo Clinic in Rochester, MN.|
754503|NCT00424645|Recruitment Period: 01/09/07 through 01/31/08. All participants recruited at UT MD Anderson Cancer Center.|Study closed early by sponsor due to low accrual. Of three patients enrolled, only two patients received blinded study drug. Study terminated prior to other randomization.
754504|NCT00424632||59 participants enrolled and 57 sequentially assigned to treatment in Schedule A or B of study treatment. Schedule A: starting dose was 5 milligrams per day (mg/day) and dose was escalated up to 100 mg/day. Schedule B: starting dose determined based on occurrence of dose limiting toxicities and maximum tolerated dose in Schedule A.
754505|NCT00424619||
754506|NCT00424593||
754507|NCT00424554||
754508|NCT00424528|Multicenter (34 sites) study.|Started: consists of all subjects who were randomized to treatment and received at least one dose of randomized study drug (Intent to treat population). One patient was randomized to the arformoterol/tiotropium group but discontinued before receiving any study medication and is therefore not included.
754509|NCT00424515|The study was activated on July 6, 2006 and closed March 1, 2011. Patients enrolled from 9 medical centers beginning April 2007 through December 2010.|
754510|NCT00424502||
754511|NCT00424489||
754512|NCT00424476||
754513|NCT00424463||
754514|NCT00424398||
754515|NCT00424385|17 patients were enrolled from our practice.|Patients enrolled failed previous chemotherapy.
754516|NCT00424372||A total of 126 subjects who completed the 13-week treatment regimen in the preceding double-blind Study A0081120 and had no serious adverse events or issues with compliance were enrolled to this study.
754517|NCT00424346|277 patients were randomized in core (CACZ885A2201): 71 were assigned to ACZ885 600 mg intravenous(iv) + 300 mg subcutaneous each 2 weeks(sc q2wk), 66 to ACZ885 300 mg sc q2wk, 69 to ACZ885 150 mg sc q4wk, 71 to placebo. 3 were randomized but not treated. All other 274 (98.9%) were treated and had post-baseline efficacy data.|Enrollment in core & CACZ885A2201E2 was determined by how many entered first extension study. Study protocols did not mandate that patients continue treatment in the extension phase and furthermore the reason for not continuing from the Core to the Extension phase was not capture. A total of 6.6% completed extensions.
754518|NCT00424294||
754519|NCT00424268||
754520|NCT00424255||
754521|NCT00424190|Patients were recruited worldwide from February 2007 to November 2007|Patients were screened for up to 24 hours
754522|NCT00424177||
754523|NCT00424047|The study was conducted at 55 sites in Australia, Europe, and Israel. Eligible participants were randomized in a 1:1 ratio to: lenalidomide plus oral pulse high-dose dexamethasone or Placebo plus oral pulse high-dose dexamethasone.|A pre-specified interim analysis revealed a highly significant benefit favoring the lenalidomide/dexamethasone regimen, crossing the pre-specified O'Brien-Fleming superiority boundary. A decision was made to unblind the study allowing those receiving Placebo/dexamethasone to receive the lenalidomide/dexamethasone regimen.
754524|NCT00424021|Participants who completed Week 24 of NCT00046319 and responded to ambrisentan were eligible for enrollment. Response to ambrisentan treatment was determined by the investigator at Week 24 of NCT00046319 based on improvement in efficacy, acceptable safety profile, and >= 4 weeks of stable, conventional pulmonary arterial hypertension (PAH) therapy.|No subjects failed screening. Subjects who completed an optional down-titration period at the end of NCT00046319 were re-titrated if their final dose was 5 mg or 10 mg.
754525|NCT00424008||In order to standardize treatment prior to randomization, participants entered a 2- to 4-week open-label Run-in period where they received MF MDI 200 mcg BID. Participants who continued to meet eligibility criteria at the completion of the Run-in Period were randomized into the study.
754526|NCT00423943||
754527|NCT00423930||
754528|NCT00423917||
754529|NCT00423891||64 enrolled. 48 treated. Participants received a minimum of 48 weeks study drug but depending on response to drug, could remain on treatment for up to a total of 120 weeks. Participants were to receive post dosing follow up after last dose, for a total of 5 years on-study (on and off study drug).
754530|NCT00423878||
754531|NCT00423852||
754532|NCT00423813||
754533|NCT00423800||56 participants were enrolled. 51 participants were screening failures, were not randomized and are not included in the study. Of the 5 participants randomized, 2 did not meet inclusion/exclusion criteria. All 5 are included in the intent-to-treat (ITT) population.
754534|NCT00423735||Per protocol criteria, the study did not continue to Stage 2 and therefore no patients were accrued to this arm.
754535|NCT00423722|Recruitment Period: 01/07/2007 - 05/02/2011. Participating sites included Silverado Hospice, Odyssey Hospice, Vitas Hospice, Houston Hospice and Christus Visiting Nurse Association (VNA) Hospice in the Greater Houston area.|
754536|NCT00423683|recruitment was slowed due to newly approved medications so study was stopped early.|
754537|NCT00423670|"765 participants were screened in the study, 598 were randomized of which 3 participants were not
~treated (Arm 1-7). Participants were assigned to Part I (with standard dosing for ribavirin) or Part II (to explore low-dose ribavirin). All participants that completed or discontinued treatment were scheduled to enter follow-up phase per protocol."|Participants in Arm 1 (Part I) who had detectable Hepatitis C Virus-ribonucleic acid (HCV-RNA) at Treatment Week (TW) 24 were offered boceprevir in addition to PegIntron and ribavirin for an additional 24 weeks of treatment, and switched to a new arm, Arm 8.
754538|NCT00423657|Patients were recruited worldwide from March 2007 to December 2007|Patients were screened for up to 24 hours
754539|NCT00423605||
754540|NCT00423592||
754541|NCT00423579||Visits 1 and 2 were for screening, combined if wash-out not required. One ineligible subject mistakenly received assignment at Visit 2 and was removed. The subject did not receive treatment. Actual enrollment: 120 subjects. Intent-to-treat (ITT) population included only evaluable subjects; as such analysis based on 112 subjects.
754542|NCT00423488||
754543|NCT00423449||
754544|NCT00423436|Recruitment Period: 04/30/03 to 12/10/08. All participants recruited at UT MD Anderson Cancer Center.|Of 84 enrolled, 16 participants dropped out before baseline assessment, prior to group assignment. Baseline data analysis was done on the remaining 68 patients (35 in the intervention and 33 in the control group).
754545|NCT00423358||
754546|NCT00423332|Seventy-one patients were randomised to study treatment: 53 to cediranib 45 mg and 18 to placebo. Following unblinding for the primary analysis, all patients, except those who had progressed on cediranib, then had the option of receiving open-label treatment with cediranib. Randomised=ITT=Safety set: Cediranib 45mg 53, Placebo 18.|
754547|NCT00423319||A total of 5765 subjects were enrolled, and 5407 were randomized to double-blind study drug.
754548|NCT00423293||
754549|NCT00423267||
754550|NCT00423189|7 patients, over a 12 month period were followed after receiving treatment of either decreased fluence(2 different fluences) and 0.5mg ranibizumab, as compared to monotherapy of 0.5mg ranibizumab at a single site|patients that were considered to have recalcitrant wet age related macular degeneration were recruited for this trial
754551|NCT00423176||
754552|NCT00423150||
754553|NCT00423098||
754554|NCT00423085||Participants were randomly assigned in a double-blind manner to one of the 3 treatment arms (placebo, rivastigmine 5 cm^2 and rivastigmine 10 cm^2) in a ratio of 1:1:1. Following the 24-week double-blind treatment phase, participants could enroll in the open-label extension phase, where all participants were titrated up to the 10 cm^2 patch dose.
754555|NCT00423046||Subjects who missed Month 7 visit and/or one or more follow-up visits were permitted to attend the next scheduled follow-up visits.
754556|NCT00422942||
754557|NCT00422903||
754558|NCT00422812||
754559|NCT00422799||
754560|NCT00422734||
754561|NCT00422695||
754562|NCT00422669|Enrollments in the Optimize RV trial began in March of 2007. The study was terminated early on March 26, 2009 after 205 subjects had been enrolled.|Seven subjects did not meet inclusion/exclusion criteria.
754563|NCT00422656|From October 2006 through November 2007, patients enrolled from the Dana-Farber Cancer Institute in Boston, MA as well as at the Community Hospital of Monterey Peninsula in Monterey, CA.|
754564|NCT00422591|Recruitment Period: 12/2006 to 01/2017|Of the 175 participants registered, six were never treated.
754565|NCT00422513||
754566|NCT00422448|Pigmented lesion clinic from October 2006 to March 2009|Insufficient prospective accrual of patients during the 1st year of enrollment lead to additional retrospective inclusion of a dataset of 21 paraffin-embedded tissue specimens from excised nevi .
754567|NCT00422422|The N01263 study began recruitment in July 2011, with subjects enrolled in the European Union, Mexico, and the United States. The study concluded in March 2013.|
754568|NCT00422383||
754569|NCT00422292|Participants were enrolled from 15 January 2007 to 16 March 2008 in 92 clinical centers in the US.|"A total of 2289 participants who met the inclusion and exclusion criteria were enrolled and vaccinated; 1643 were included in the final analyses presented.
~625 participants that got ActHIB as part of their 12 month study vaccinations prior to Protocol Amendment 2 approval were excluded from all analyses and presented in a separate report."
754570|NCT00422279|Four patients have been recruited to participate in this study after they met the inclusion criteria, all patients have been recruited at the Medical college of Georgia, Augusta, GA, USA|all the four study patients met the inclusion criteria no run in's have been encountered, all the patients completed this study at the scheduled follow up visits
754571|NCT00422227|Subjects were recruited in the Asia-Pacific Region from June 2007 to October 2008.|Screening of subjects occurred up to 2 weeks before randomization followed by a treatment phase of 16 weeks and a 2-week safety follow up.
754572|NCT00422201|18 patients recruited. Recruitment terminated.|
754573|NCT00422162||Of the 392 patients who signed informed consent, 339 were randomized.
754574|NCT00422097||Of 58 enrolled, 44 received treatment: 10 no longer met enrollment criteria (2 brain metastases, 2 bowel obstruction, 1 high aspartame aminotransferase [AST], 1 high AST/alanine transaminase, 2 low platelets, 1 hospitalized, 1 gastric adverse event [AE]); 2 withdrew consent/changed mind; 1 AE; 1 sponsor administrative reason.
754575|NCT00422058|19 sites in 8 countries: Denmark (3), Sweden (2), Finland (3), UK (3), Netherlands (1), Belgium (1), Spain (4) and Czech Republic (2)|Between screening and randomisation, eligible subjects were included in a 2-week single-blind run-in period in which all subjects were placed on a hypocaloric diet. The dose of liraglutide and placebo was increased during the first 4 weeks after randomisation until maintenance dose was reached. Orlistat dose was fixed from randomisation.
754576|NCT00422032|Recruitment Period 1/31/06 - 9/21/09. All patients were registered at The University of Texas M.D. Anderson Cancer Center.|Of the 60 participants registered on this study, two (2) were excluded prior to receiving treatment.
754577|NCT00421993|"Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007.
~Types of locations: Dermatology Clinics, Dermatology Research Centers."|The specified washout period up to Baseline for TOPICAL facial treatments was 1 week (light therapy/exfoliation/blackhead removal) or 2 weeks (anti-inflammatory drugs/salicylic acid/steroids/antibiotics/laser) and for SYSTEMIC medications was 2 weeks (anti-inflammatory drugs), 4 Weeks (steroids/antibiotics), or 6 months (anti-acne/contraceptives).
754578|NCT00421954|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|
754579|NCT00421928|The recruitment period for this out-patient, multicenter study occurred between 07 February 2007 and 15 July 08.|The study consisted of a screening period (duration up to 14 days), a washout period (duration 3 to 7 days), a double-blind active treatment period with titration period (duration 3 weeks) and maintenance period (duration 12 weeks)
754580|NCT00421889||
754581|NCT00421733||
754582|NCT00421707|A total of 132 participants with irritable bowel syndrome (IBS), as classified by the Rome II criteria for IBS, but otherwise healthy, were randomized in this study. Study was conducted at 20 centers (14 centers in united states, six centers in Canada) from 14 October 2006 to 25 June 2008|
754583|NCT00421603|Participants were recruited by local advertising (internet, print, radio, television, and subway) or by clinical referrals in the New York City metropolitan area between January 2007 and February 2010.|Prior to group assignment patients participated in a one week placebo lead-in.
754584|NCT00421408|Recruitment started in June 2007 and the last participant was screened in October 2010. Subjects were recruited to the Yale Center for Clinical Investigation in New Haven, CT or the University of Connecticut Health Center in Farmington, CT.|Subjects were randomized 1 month after screening if they were found eligible after screening. Between screening and randomization their calcium and vitamin D intake was stabilized for baseline measurements.
754585|NCT00421343||
754586|NCT00421174|Patients were enrolled from September 2007 to August 2011 from 12 different sites.|
754587|NCT00421148|Recruited participants were stratified between Infants (28 days-23 months of age), Children (2-11 years of age), Adolescents (12-17 years of age) and Adults (18-65 years of age). For Participant Flow, participants are included in the treatment group to which they were randomized.|One adolescent participant was inadvertently randomized to Children: Sugammadex 4 mg/kg, but was included in Adolescents: Sugammadex 4 mg/kg for safety analyses. One participant was randomized to Adolescents: Sugammadex 0.5 mg/kg, but received sugammadex 5.0 mg/kg & was included in the Adolescents: Sugammadex 4 mg/kg for safety analyses.
754588|NCT00420992||
754589|NCT00420927||
754590|NCT00420849||
754591|NCT00420784||A total of 465 subjects were enrolled, of which 12 subjects discontinued the study prior to study drug administration. A total of 453 subjects started treatment.
754592|NCT00420771||
754593|NCT00420745||
754594|NCT00420641|The study was conducted on male and female participants, aged 18 to 64, with major depressive episodes associated with major depressive disorder (MDD), from 19 December 2006 to 24 June 2008 at 35 centers in 10 countries of Canada (4), Bulgaria (2), Croatia (5), France (4), Germany (4), Italy (2), Poland (3), Chile (3), Costa Rica (3) and India (5).|A total of 504 participants were randomized in ratio of 1:1:1 to receive placebo or GSK372475 (1.0 milligram per day [mg/day] to 1.5 mg/day) or paroxetine (20 mg/day to 30 mg/day) for 10 week double blind treatment phase.
754595|NCT00420628|108 subjects aged 0-6 years with lid inflammation were recruited from 15 clinic locations in the US. First subject was enrolled on 11/07/2006, last subject visit was 1/5/2009.|108 subjects were randomized to receive loteprednol/tobramycin or its vehicle in a 2:1 ratio. Subjects will receive warm compress lid treatment 2 times daily, before administration of study medication (as applicable) for the 14-day treatment duration.
754596|NCT00420511|Participants were recruited from outpatient clinics at the Leadership Sinai Centre for Diabetes between February 2007 and October 2008.|Participants underwent prerandomization phase of 4-8 weeks of intensive insulin therapy (IIT) consisting of basal detemir and premeal insulin aspart. Only participants who achieved fasting glucose <7.0 mmol/L 1 day after completing IIT were randomized to either sitagliptin 100 mg once daily or matching placebo.
754597|NCT00420459||
754598|NCT00420420|First Patient Dosed: 13 JAN 2007; Last Patient Last Treatment: 14 AUG 2008. 15 U.S. outpatient centers.|At Visit 1, patients were assessed using the protocol inclusion and exclusion criteria, then, if deemed eligible, patients were randomized at Visit 3.
754599|NCT00420407|recruitment location - Emergency room Feb 2007- Feb 2009|clinical indication prohibiting potential use of vasopressin.
754600|NCT00420381||Completers are defined as receiving at least one dose of study drug and treated until progressive disease.
754601|NCT00420342|Subject enrollment began on 16-Jan-2007 and lasted over a period of 6 months at 10 study centers in the U.S. There was no enrollment at 2 sites (108 and 110). Site 102 enrolled 14 subjects and site 105 enrolled 56 subjects (28 of whom consented to the sodium sensitivity analysis). All other sites enrolled 7 or fewer subjects.|Screening involved office cuff BP measurements at 3 visits to evaluate prehypertension. Of the 178 enrolled, 86 subjects were screen failures. The full analysis and safety sets had 90 subjects who took at least 1 dose of study medication (2 subjects did not confirm if they ever took the study medication).
754602|NCT00420316||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
754603|NCT00420303|Patients were recruited worldwide from February 2007 to June 2008.|Patients were screened up to 6 weeks.
754604|NCT00420290|This study was conducted at the Vanderbilt University Medical Center and Nashville Veterans Affairs Outpatient Dialysis units between January 2008 and May 2010.|There is a 3-month screening period following enrollment to determine level of inflammation. To be eligible to participate in the intervention phase of the study and be assigned to a group, participants must have three consecutive CRP levels > 5 mg/L. Although 31 subjects were enrolled, only 22 were eligible to be assigned to a group.
754605|NCT00420238|Subjects with advanced ankylosing spondylitis (AS) by Modified New York criteria, advanced and severe disease with intervertebral bridges, and an axial defined by a score of ≥30 for overall level of AS neck, back, or hip pain on the BASDAI were eligible to participate in the study and were randomized at 19 study sites.|Subjects completed a screening period of up to 6 weeks duration prior to entering the treatment period; 95 subjects were screened, and 82 subjects were randomized.
754606|NCT00420212|Subjects were screened and enrolled at 198 investigational sites in 28 countries.|From screening, 1237 eligible subjects were equally randomized. Of these, 1234 subjects received at least one dose of study treatment and comprised the intent-to-treat (ITT) and safety populations.
754607|NCT00420199||
754608|NCT00420147||
754609|NCT00420095||
754610|NCT00420056||
754611|NCT00420017|Between September 2004 and November 2008, 80 patients were enrolled in the study, with 40 patients randomized to each arm. Patients were recruited from an academic medical center prior to undergoing esophageal surgery|133 patients were screened for eligibility. 39 were excluded prior to consent d/t presence of exclusion criteria or declined participation. 94 were consented. 14 did not participate: 3 had pre-op exclusion criteria; 4 were withdrawn because the study protocol was delayed; 7 were excluded because they developed intra-operative atrial fibrillation
754612|NCT00420004||A total of 701 participants were included in a screening/washout period (from 3 to 30 days in duration) prior to group assignments; 232 participants discontinued during this period, and 469 participants were randomized. There was an 8-week Double-blind Phase followed by a 1-week Discontinuation Phase after abrupt discontinuation of treatment.
754613|NCT00419952|First patient enrolled on 8 February 2007, the last patient completed the study on 30 November 2009. The study randomized participants only in the United States.|The study included a run-in period of 2 weeks when all patients were prescribed budesonide HFA pMDI 160 μg times 2 actuations BID at individual daily doses and rescue medication, as needed. To be randomized to treatment the patients needed to show pre-dose FEV1 of ≥50%. One patient in the budesonide group did not receive any dose.
754614|NCT00419926||
754615|NCT00419770||
754616|NCT00419757|39 centres in United States enrolled 558 patients with asthma into this study. 308 patients were excluded: 279 for incorrect enrollment/eligibility criteria not fulfilled, 14 for voluntary discontinuations, 2 for development of study specific discontinuation criteria, 2 for adverse events, 10 were lost to follow-up|Male or female, Hispanic (self-reported), ≥12 years
754617|NCT00419744|First patient randomized on 02 January 2007. The last patient completed study on 27 August 2009. The study randomized patients in the United States and Mexico (93 investigational sites), South America (48 investigational sites), and South Africa (20 investigational sites).|The study consisted of an initial screening visit (Visit 1) and 2-week run-in enrollment visits (Visits 2 and 3) prior to being randomized to 1 of 3 treatment groups
754618|NCT00419666|The study was conducted in 7 sites (5 in United States and 2 in Canada) between 01 Aug 2006 (first participant enrolled) to 24 Sep 2009 (last participant completed).|A total of 25 participants were enrolled and completed the study.
754619|NCT00419562||
754620|NCT00419445||
754621|NCT00419393|The study began December 2007 recruiting in the United States, Poland, Mexico, and the Russian Federation. The study completed March 2010.|
754622|NCT00419380||
754623|NCT00419341|A total of 12 centers in the United States enrolled subjects for this study.|
754624|NCT00419315||
754625|NCT00419263||
754626|NCT00419159||
754627|NCT00419120|11 patients were recruited between Dec 2006 and July 2007. Patients were recruited from 4 academic centers across the US. One patient withdrew from the study prior to implantation of the Neo-bladder construct and is included in the safety analysis, but not in the efficacy analysis (all implanted population).|This was an open label single arm study.
754628|NCT00419094|The Efficacy (EFF) population is defined as all subjects in the Intent to Treat (ITT) population who enter into the Previous Antiepileptic (AED) Discontinuation (D/C) Phase. The Per Protocol (PP) population consists of all subjects in the EFF population who have no important protocol deviations related to efficacy.|Subjects are to be randomized into treatment with either Keppra XR 2000 mg/day or Keppra XR 1000 mg/day in a 3:1 ratio.
754629|NCT00419003|The intent-to-treat sample (n=26) was recruited from media/internet advertising (14), psychiatrist referral (8), or self-referral from the New York Mood Disorders Support Group (4). Patients had marked depressive severity, chronicity, and anxiety comorbidity, and were highly pharmacotherapy-resistant.|2-wk psychotropic medication washout period (4 wk for fluoxetine)
754630|NCT00418977|Recruitment period Oct 2007 to Feb 2011 primarily via physicians and other clinicians/centers evaluating or treating children and adolescents with eating disorder symptoms.|
754631|NCT00418964||
754632|NCT00418951|Recruitment Period: 11/3/2006 to 8/4/09. All patients registered at The University of Texas M.D. Anderson Cancer Center.|Eight of 120 patients registered never received study drug, therefore were excluded from the study.
754633|NCT00418938||We enrolled 266 subjects, but we only perform analyses on the Full Analysis Set, defined as all randomized subjects who provide informed consent before the initiation of any study specific procedures and who receive at least one dose of panitumumab or bevacizumab. There are 264 patients in this Full Analysis Set.
754634|NCT00418886|First patient enrolled 09 january 2007, last patient enrolled 29 February 2008, cut off date 05 September 2008|
754635|NCT00418834|"Phase III
~First Patient In: 28-Feb-2007; Last Patient Last Visit: 01-Oct-2008
~143 centers worldwide (United States, Canada, Poland, Romania, Ukraine and Russia)"|"Patients were stratified based on baseline LDL-C levels and presence or absence of atherosclerotic vascular
~disease to achieve balance across treatment groups."
754636|NCT00418717|Subjects were recruited in Japan from January 2007 to September 2007.|Subjects were screened up to 4 weeks and received 25 mg etanercept (as test article) BW for 4 weeks during treatment period A. At the end of the period A, the same cohort of subjects entered period B and received etanercept 50 mg (as test article) QW for 8 weeks to assess the efficacy and safety of a QW regimen.
754637|NCT00418691|Recruitment Period: March 2004 - April 2009. All recruiting done at UT MD Anderson Cancer Center, Neuro-Oncology Clinic.|Of the 34 registered patients, one enrolled patient did not join study and therefore was never included in any group assignment.
754638|NCT00418665|Participants were enrolled from 14 March 2007 through 24 July 2008|
754639|NCT00418574|"Study population was recruited in 139 sites (Hospitals/University Clinics) distributed in Europe (Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland and Spain) and US.
~Date of first patient randomised: 08 December 2006 Date of last patient randomised: 26 December 2008"|
754640|NCT00418561||
754641|NCT00418522||
754642|NCT00418457||
754643|NCT00418379|First Patient First Visit 08 DEC 2006, Last Patient Last Visit 07 SEP 2011|
754644|NCT00418314||
754645|NCT00418262|The study the recruited 29 (21 male/8 female) children between 10/18/2006 and 9/21/2011. The children were recruited from a prior efficacy trial. Participants for the efficacy trial were drawn from physician referral resources, self-referral, and a pool of subjects identified for a study sponsored by the Center for Disease Control and Prevention.|Two recruits declined particicpation in this open-label study. Participants continued to take atomoxetine/placeblo (depending on prior RCT assignment) until entry into this open label study.
754646|NCT00418184|"Children at the age of 6-13 years were screened at the Geha mental health center, Israel, for participation in the study. Recruitment of participants was achieved by vast advertisement in newspapers, internet and in practitioners clinics. Participants enrollment period March 2007 to March 2008"|
754647|NCT00418145||
754650|NCT00418015|Laboring subject recruited from 10/2005 to 9/2006 Post cesarean delivery subjects recruited from 10/2005 to 5/2007|Subjects were excluded from the labor analgesia group if they had received an opioid analgesic before initiation of intrathecal analgesia or if they received neuraxial analgesia before 2cm of cervical dilation.
754651|NCT00417989||
754652|NCT00417976||
754653|NCT00417963|Enrollment commenced on October 7, 2005 and was completed on November 6, 2007. A total of 486 patients from 34 investigative sites within the United States were enrolled, including 79 in the roll-in cohort and 407 in the pivotal cohort. The Roll-in cohort is intended to provide initial training and verification of procedure technique|Each site was required to enroll at least one roll-in patient prior to commencing the pivotal phase to demonstrate appropriate training and technique. Each roll-in patient was required to meet the same eligibility criteria and follow the same follow-up schedule as the pivotal cohort. The pivotal cohort represents the intent-to-treat population.
754654|NCT00417885||
754655|NCT00417859||8 patients were excluded
754656|NCT00417612||
754657|NCT00417482|Patients were recruited from memory clinics including Alzheimer Research Centers, geriatric psychiatry clinics, VA clinics, physician referrals and advertising.|"180 Patients with Alzheimer's disease (AD) & psychosis or agitation-aggression received open treatment with risperidone for 16 weeks in Phase A. Of 180 patients, 112 were responders and 110 were randomized in Phase B.
~Phase B: 110 responders were randomized, double-blind, to one of three arms in Phase B."
754658|NCT00417417|Patients with coronary artery disease were recruited from the Clinical Center outpatient clinic, and began in January, 2007.|
754659|NCT00417274||
754660|NCT00417248||
754661|NCT00417170|Screening for eligibility took place up to 6 weeks prior to study start. Participants stopped taking all medications during the 6 week screening period and washed out of all medications, including antihypertensive medication prior to randomization and start of study dosing.|
754662|NCT00417079|Multicenter study: 146 actives sites from 26 countries in Europe, USA, South America and Asia Pacific region. Study initiation date: January 2nd, 2007; study completion date/study cut off date: September 25th, 2009.|"165 patients signed informed consent but were not randomized and considered as screen failure.
~Intention to Treat Population (ITT or randomized patients): 755 patients (377 mitoxantrone, 378 cabazitaxel).
~Safety population (treated patients): 742 patients (371 mitoxantrone, 371 cabazitaxel) (Patients not treated: 6 mitoxantrone, 7 cabazitaxel)."
754663|NCT00417027|Nulliparous women in spontaneous labor were asked to participate shortly after admission to the Labor and Delivery Unit at Prentice Women's Hospital. Immediately following the routine preanesthetic interview, subjects were approached and informed, written consent was obtained.|
754664|NCT00416949||
754665|NCT00416884||
754666|NCT00416793|Recruitment period: December 7, 2006 to August 26, 2008. All recruitment was done at UT MD Anderson Cancer Center.|The study was terminated early since the protocol met prospective criteria for early stopping.
754667|NCT00416715||
754668|NCT00416624|Two hundred and thirty-nine (239) participants were enrolled at 10 Mayo Clinic Cancer Research Consortium (MCCRC) sites between February 2007 and December 2008.|There were two canceled participants and 1 ineligible participants prior to study medication begins. These three participants were excluded from all analysis.
754669|NCT00416598|Between November 2006 and July 2010, 546 participants were recruited.|
754670|NCT00416572|Potential participants were identified through nurse referrals of consecutive and potentially eligible patients from hospital medical oncology clinics and physicians' offices in southwestern Pennsylvania.|
754671|NCT00416520||
754672|NCT00416494|Patients were recruited between September 2003 and July 2005 in the Duke Cancer Center and Duke Oncology Network sites.|
754673|NCT00416455|The study was activated on 9/24/2007. Combidex MRI was discontinued on 11/09/2009 due to lack of study drug. GOG 0233 (NCT 00416455) closed to accrual on 6/21/2013.|
754674|NCT00416312|All NHL patients treated by either Bexxar or Zevalin|
754675|NCT00416195||
754676|NCT00416182|Patients undergoing sinus surgery meeting inclusion criteria were approached in the outpatient or hospital setting|upon providing informed consent, subjects were randomized and blinded to treatment or placebo groups
754677|NCT00416078||
754678|NCT00415909|Recruitment Period: December 21, 2006 to June 27, 2008.|
754679|NCT00415870||
754680|NCT00415857|Recruitment period: December 20, 2006 to March 13, 2009. All recruitment done at the University of Texas (UT) MD Anderson Center.|Due to the unavailability of the study drug (vaccine) enrollment was halted and the study eventually terminated when additional attempts were unsuccessful to obtain a supply of vaccine.
754681|NCT00415636||
754682|NCT00415623|Twenty-four (24) centers in Japan|Consent was taken from 414 patients, 356 patients who met the screening criteria received amlodipine 5 mg. After the 8 weeks of screening treatment, patients who met the entry criteria for double-blind period were randomized to either the amlodipine 10 mg group or the amlodipine 5 mg group at a ratio of 1:1.
754683|NCT00415610|Patients 18 years and older presenting to site hospital ED and ICU areas within 6 hours of symptom onset for ≤ 60 cc volume intracerebral hemorrhage, with GCS ≥ 8, systolic blood pressure ≥ 170 mmHg and meeting all inclusion/exclusion criteria were enrolled following consent by themselves or a family member/legally authorized representative.|A progressive, three-tiered approach to lowering systolic blood pressure with DSMB review after enrollment in each successive SBP range was completed. Safety was determined at each level before progressing to the next. Subjects meeting criteria and consenting to participate were considered enrolled and have been included in the data analysis.
754684|NCT00415597||
754685|NCT00415532|First Subject Enrolled: 20-Dec-2006 Last Subject Enrolled: 01-Nov-2007|
754686|NCT00415519||
754687|NCT00415506|Subjects were recruited from January 2007 through March of 2010. Subjects were recruited from the investigator's medical clinic.|Of the 20 subjects enrolled, two subjects had both orbital disease and scleritis. These two subjects were followed for both indications.
754688|NCT00415493||
754689|NCT00415363||
754690|NCT00415194||
754691|NCT00415168||56 participants signed informed consent and 3 participants were screen failures.
754692|NCT00415051|Twenty subjects were planned; 31 were screened, 11 did not meet the inclusion/exclusion criteria, 20 satisfied inclusion/exclusion criteria, 20 were enrolled, 1 was excluded (received another vaccine within 30 days of intended MP-12 vaccination), and 19 received vaccine and completed the study.|
754693|NCT00414973||364 participants were randomized, but 2 females did not receive study drug and are not included in any of the analyses.
754694|NCT00414960||
754695|NCT00414908|Subjects were recruited in centers in Bulgaria, Poland, Russia, Serbia, Ukraine and US between April 2007 and August 2008. This report presents the double-blind (DB) period of the study as well as the Open Label (OL) results.|There was a run-in with a 5-day of single-blind placebo treatment. One hundred and eighty subjects were consented and 179 entered the run-in. A total of 54 subjects were randomly allocated to treatment. Only two subjects did not complete the DB period of the treatment because of protocol violation. Fifty one patients entered the OL period.
754696|NCT00414817|Recruitment occurred, starting in October 2007 via electronic medical record query. Calling campaigns ended in April 2009.|14,064 adults taking medication for asthma were pre-randomized to intervention or usual care (UC). However, only those individuals who ever qualified for an intervention call were included in the analysis sample. This included 6905 pre-existing inhaled corticosteroid (ICS) users (our primary analysis sample) and 1612 new ICS users.
754697|NCT00414726|February 2007-June 2009|
754698|NCT00414700|Recruitment by orthopaedic surgeons (medical clinic). Recruitment period: 21 February 2002 to 23 November 2004.|Enrolled patients excluded: Not fulfilling inclusion criteria. Withdrawal of consent.
754699|NCT00414661|Participants who received at least 1 dose of CP-690,550, placebo or adalimumab for the treatment of Rheumatoid Arthritis (RA) in previous studies and had ceased participation in other Phase 2B or 3 randomized, controlled or open-label study of CP-690,550 were eligible for this study.|
754700|NCT00414635|Recruitment took place between August 21, 2006 and November 9, 2007. Recruitment occured at multiple site locations (research clinics and private practice).|
754701|NCT00414609||
754702|NCT00414596||
754703|NCT00414544||
754704|NCT00414518||
754705|NCT00414466|A total of 254 subjects were enrolled into the study between December 2006 and October 2009.|During a 2-week screening period subjects were required to meet eligibility criteria including maintaining stable pain medications and demonstrating a numerical pain rating score of 6 or greater averaged over the last 7 days of screening. A total of 170 subjects met eligibility criteria, were implanted with an infusion system and were randomized.
754706|NCT00414453|7-6-2006 to 9-23-2008 at the medical center|19 subjects were enrolled in this study however the study was terminated due to not reaching enrollment goals in a timely manner. Therefore there was no data analysis completed for this study. We do not have randomization data for these participants because the data is not available and is locked.
754707|NCT00414440||
754708|NCT00414388|Recruitment was from our clinic population.|Eligible patients were those who progressed while receiving chemotherapy (docetaxel or mitoxantrone)or within 12 weeks of stopping chemo.
754709|NCT00414310|Recruitment Period: 12/13/2006 to 07/05/2010. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the 153 participants registered on the study for Decitabine (DAC) with or without Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML), three were screen failures therefore 150 patients were randomized with 149 participants treated.
754710|NCT00414271||
754711|NCT00414206||
754712|NCT00414167|Sixty-one overweight and obese women with BED were recruited from the community via advertisements. Participants were enrolled from November 2006 to December 2010. Assessments and clinic appointments were held in a medical school research clinic.|
754713|NCT00414076|Randomized (adaptive), open-label phase II of Letrozole (experimental) vs. observation (control) in patients with clinical stage I or stage II leiomyosarcoma|physical exam, vital signs, ECG, laboratory tests, chest x-ray, CT or MRI
754714|NCT00414050|15-Nov-2006 (First Participant Enrolled in Study) to 24-Oct-2007 (Last Participant had their Last Visit). Last participant completed follow-up: 16-Oct-2007.This study was conducted at 15 sites; 14 in Finland and 1 in Norway.|
754715|NCT00414011||
754716|NCT00413972||
754717|NCT00413959|Rituximab (R) are alone or R based chemo programs are front line approach LG-NHL pts requiring therapy. Identifying programs that are effective in the elderly pts is challenging. These pts were recruited in our private practice.|Eligible pts had LG-NHL requiring treatment. Mantel cell NHL pts who were'nt transplant eligible and MALToma pts who failed RT and antibiotics were allowed.
754718|NCT00413920||
754719|NCT00413894||A total of 661 participants with renal anemia due to chronic kidney disease (CKD) were enrolled; of which, 424 participants were treated with methoxy polyethylene glycol-epoetin beta (C.E.R.A) and are included in results.
754720|NCT00413777|A phase 2, multi-center, open-label trial, to determine the safety, tolerability, and efficacy study of split-dose oral regimens of tolvaptan tablets in a range of 30 to 120 mg/d in autosomal dominant polycystic kidney disease (ADPKD) participants.|This was an open-label study with a 30-day Screening period, Titration period (Day 1 to Month 2), Fixed-dose period (Month 2 to Month 36), and Extension period (12 Months).
754721|NCT00413699|"Initial period (IP): conducted at multiple sites, participants were assigned to Tofacitinib 5 mg and 10 mg BID. Extension period (EP): participants who took part initially in IP, completed 2 years of lymphocyte assessment in IP, given consent, were enrolled in EP and assigned to Extension Period: Tofacitinib 5 mg. EP was conducted in 2 countries."|Participants had previously participated in qualifying studies (A3921019, A3921025, A3921032, A3921035, A3921044, A3921045, A3921046, A3921064, A3921068, A3921069, A3921073, A3921109, A3921129, A3921130, A3921152, A3921237) prior to enrollment in initial period.
754722|NCT00413660||
754723|NCT00413634|Patients were between 18-50 years (young) and 65 or older (elderly) with a diagnosis of essential thrombocythemia (ET) and receiving a stable dose of anagrelide <=5mg/day for at least 4 weeks.|The study comprised four phases: Screening (patients take their normal regimen of anagrelide), a run-in period (patients divided their normal anagrelide daily dose equally into two daily doses), Pharmacokinetics (PK) sampling day (patients take normal morning dose), and follow-up (patients were contacted by phone 30 days after PK visit).
754725|NCT00413478|Recruitment Period: 09/21/2006 to 12/01/2010. All recruitment done at The University of Texas MD Anderson Cancer Center.|The study was discontinued after 9 participants enrolled because of lack of efficacy and slow accrual.
754726|NCT00413413|A total of 1134 patients were enrolled into the single-blind period of the study, and 216 (19%) were discontinued. In total, 918 patients were randomized to the three treatment groups.|
754727|NCT00413400|Recruitment period 12/2006 to 3/2009|
754728|NCT00413374|"Enrollment began in September 2006 and was completed in March 2008. Of 473 patients screened, 40 were enrolled.
~Patients with newly diagnosed acute DVT or PE were screened in the Emergency Department or Vascular Laboratory at Brigham and Women's Hospital."|
754729|NCT00413335|Subjects were recruited from a multi-ethnic cohort of obese children and adolescents drawn from the Pediatric Obesity Clinic at Yale-New Haven Hospital.|Obese children and adolescents with positive risk factors for Type 2 Diabetes (T2DM) were screened by using a standard oral glucose tolerance test (OCTT).
754730|NCT00413283|Participants were enrolled from 28 December 2006 through 11 August 2008.|
754731|NCT00413244|Subjects recruited for the study were male patients with stable cardiac status at least 3 months after Percutaneous Coronary Intervention (PCI) at the Cardiac Catheterization Lab of Mount Sinai Hospital from July 2007 to August 2013.|
754732|NCT00413231||
754733|NCT00413218|Consenting male and female participants ≥ 18 with candidemia or an invasive Candida infection who had a positive blood or tissue culture obtained within 96 hours prior to randomization and meeting the inclusion/exclusion criteria were enrolled in the study.|Participants were stratified at randomization by geographical region and baseline neutropenic status.
754734|NCT00413192||A total of 128 participants were enrolled. Of these 128 participants115 were eligible to continue in the study following reassessment of study eligibility in which 12 participants previously found eligible and began treatment, were then assessed as ineligible. One participant was not treated.
754735|NCT00413166|Recruitment Period: December 5, 2006 to April 3, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.|Pfizer withdrew gemtuzumab ozogamycin (GO) from market based Food & Drug Administration recommendation. As such, protocol modified to Idarubicin Day 1 of induction in high-risk participants & in low risk participants with rising white blood count (WBC), Idarubicin administered to low-risk patients in whom WBC >10,000 after initiation of ATRA + ATO.
754736|NCT00413153|Subjects were recruited through information given to HIV-care providers, postings in HIV-community organizations, newspaper advertisements, and the Massachusetts General Hospital research patient data registry. Recruitment began in March, 2006, and continued through May, 2008.|After screening visit to determine eligibility, subjects were asked to continue their current antiretroviral medications until the baseline visit, immediately after which they were randomized to continue lopinavir/ritonavir or switch to atazanavir/ritonavir.
754737|NCT00413062|This study recruited participants from North America and South America|In total, 2281 participants were randomized (NOMAC-E2 n=1710; DRSP-EE n=571) but 2220 participants were treated (NOMAC-E2 n=1666; DRSP-EE n=554).
754738|NCT00413049||Two patients in the valsartan/amlodipine group were excluded from the intent-to-treat population used for the efficacy analyses for having no post-baseline efficacy assessment.
754739|NCT00413036||217 participants were enrolled and received at least one dose of study medication.
754740|NCT00413010|The study was conducted in 55 centers in 8 countries (United States, Russian Federation, Czech Republic, Ukraine, Serbia, Hungary, Finland, and Estonia).|After a screening phase (Period 1), subjects entered an 8-week open-label treatment optimzation phase (Period 2). Only those subjects who partially responded to background Generalized Anxiety Disorder (GAD) treatment (escitalopram, paroxetine, or venlafaxine XR) and met all inclusion/exclusion criteria were eligible for randomization (Period 3).
754741|NCT00412984||20998 participants were enrolled, and 18201 were randomized.
754742|NCT00412971||
754743|NCT00412958|The first patient was recruited on 29 Mar 2007 and the last patient completed the study on 02 Oct 2008.|
754744|NCT00412932|Participants were recruited at 37 US sites (private medical practices and small clinics) over 13 months (Nov 29,06 to Dec 28,07) from each physician's clientele base. Approximately 200 eligible participants, men and women at least 65 years of age with hypertension or uncontrolled hypertension on current medication, were to receive active treatment|After 3-4 weeks of placebo, patients with a systolic pressure (SBP) ≥150 ≤199mmHg and diastolic pressure (DBP) ≤109 mmHg at the last 2 visits, and 8-hr daytime SBP >140 and ≤199 mmHg and DBP ≤109 mmHg by ambulatory blood pressure monitoring were entered.All started with Olmesartan 20 mg and were titrated if their blood pressure was not controlled
754745|NCT00412893|Consenting adult patients with proven, probable or possible invasive fungal disease (IFD) caused by Aspergillus species or other filamentous fungi, meeting the inclusion/exclusion criteria, were enrolled in the study.|Participants were stratified by geographic location (North America; Western Europe plus Australia and New Zealand; and Other Regions), whether or not they underwent an allogeneic bone marrow transplant (BMT) and whether or not they had uncontrolled malignancy.
754746|NCT00412867||
754747|NCT00412854||
754748|NCT00412841||
754749|NCT00412750|This is a randomized, open-label, controlled, multi-center two-year study enrolling male and female subjects starting December 2006 and ending February 2009.|
754750|NCT00412737|Out of total 477 participants who were randomized to receive study treatments, 2 participants were not included in the study population due to lack of efficacy data. Thus, results are reported only for 475 participants.|One participant was randomized to placebo group but received oseltamivir for the first 9 weeks of the study. This participant was included in the placebo group in the Intention-to-treat (ITT) analysis population, but in the oseltamivir group in the safety analysis population.
754751|NCT00412607|The first subject was enrolled on April 3, 2007. Subject enrollment was completed on May 19, 2009 after reaching the minimum enrollment criteria of two hundred forty-nine (249) subjects. Subject follow-up was completed on June 8, 2012.|
754752|NCT00412542|Recruitment Period: October 13, 2003 to October 22, 2008. All participants were recruited at UT MD Anderson Cancer Center.|Of the 78 participants enrolled, three (3) were considered not evaluable.
754753|NCT00412529||
754754|NCT00412516||
755029|NCT00396318||Five patients were randomized but not treated, therefore the modified intent to treat (MITT) analysis population was 246.
754755|NCT00412464|Subjects were recruited between September, 2006 and June, 2009 at 4 sites (Children's Hospital Los Angeles, Children's Hospital of Orange County, Texas Children's Hospital and Nationwide Children's Hospital). All subjects were in the inpatient units of these hospitals for the duration of their study participation.|All recruited subjects entered and completed the study.
754756|NCT00412451|The first patient was enrolled on 15 December 2006 and the last patient completed the last visit on 19 January 2010. All patients were selected in medical clinics|The trial investigated 3 doses: 25, 75 and 125µg in 3 consecutive cohorts. Patients in each cohort were to be randomized to active treatment or sham injection in a 3:1 ratio. Enrolment into the high dose microplasmin groups was to start only after acceptable safety had been achieved with the previous doses as determined by a Study Safety Committee.
754757|NCT00412425|Recruitment period: 11/17/2006 - 8/1/2008. All recruitment done at UT MD Anderson Cancer Center.|
754758|NCT00412373||391 subjects were enrolled in the study. There were 80 screen fails (did not meet inclusion/exclusion criteria). 311 subjects were randomized. 309 subjects were included in the Safety Analysis Set (randomized and took at least one dose of study drug). 304 subjects were included in the Intent-to-Treat analysis set (had baseline/postbase PANSS).
754759|NCT00412360||
754760|NCT00412243|Recruitment Period 3/21/2006 - 3/3/2011; all patients were registered at The University of Texas M.D. Anderson Cancer Center.|One enrolled participant was excluded.
754761|NCT00412217||
754762|NCT00412113||The study enrolled 244 evaluable subjects. Drug treatments were used prior to the start of the study in all subjects in the Caduet and therapeutic lifestyle changes (TLC) group and the Norvasc and TLC group. Amlodipine was used by all subjects prior to entry. The study's four arms are two groups, each with drug group and matching placebo.
754763|NCT00412087||564 women consented to participate in Aim 1 of the study (collection of cross-sectional baseline measures only). Of those 564 women, 265 were enrolled in Aim 2 of the study; only the Aim 2 cohort were randomized to intervention groups and followed through delivery.
754764|NCT00412074||
754765|NCT00412061||Total 429 patients were randomized to double blind phase of treatment. 170 patients moved to the Open Label Phase.
754766|NCT00411788||
754767|NCT00411762||
754768|NCT00411749|Study was conducted at 8 sites in Japan from 2006 to 2009.|
754769|NCT00411671|Recruitment period: November 2006 to February 2010. All participants recruited at The University of Texas MD Anderson Cancer Center.|
754770|NCT00411645||
754771|NCT00411632|Thirty-seven (37) patients were registered into this trial. All thirty-seven (37) patients were eligible to participate in this trial.|Participants enrolling in this study must first be enrolled in the BATTLE umbrella protocol and must meet all of the BATTLE eligibility criteria. Participants enrolled in the BATTLE program will be assigned to a specific biomarker-integrated study based on the adaptive randomization model.
754772|NCT00411619||
754773|NCT00411554|"Phase III.
~First patient in: 6 January 2007. Last patient, last visit: 15 August 2007.
~The study was conducted at 71 centers in Japan."|Patients at least 20 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and <10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.
754774|NCT00411463||
754775|NCT00411450|This study was conducted at 56 sites in the United States. The first patient enrolled on 30 November 2006 and the last patient enrolled on 07 January 2008.|Participants recived second-line therapy until disease progression, intolerability, death, or study withdrawal. Participants completed a safety visit 4 weeks after the last dose. Participants were followed for survival every 12 weeks from the safety visit until the end of the study; the data cut-off date for results is 2 January 2009.
754776|NCT00411411|Patients recruited from Jan. 2008 to Dec 2009 through out-patient clinic and advertisement|
754777|NCT00411398|subjects were recruited easily by radio and newspaper advertisements|
754778|NCT00411216||
754779|NCT00411151|First patient in (FPI): 15.02.2007 Last patient out (LPO): 20.08.2009|
754780|NCT00411086|Recruitment period: December 2006 and May 2009. All recruitment was done in medical clinics in participating Community Clinical Oncology Program sites.|
754781|NCT00410904|Cancer center clinic.|
754782|NCT00410891||
754783|NCT00410826|Patients were randomized between December 2006 and October 2011.|
754784|NCT00410813||
754785|NCT00410761|First patient enrolled 23 November 2006, last patient enrolled 19 October 2007, cut off date 31 July 2009. 437 patients were enrolled.|
754786|NCT00410605|Participants were recruited from the University of Wisconsin (UW) Hospital and Clinics, the UW 1 South Park Clinic, and the Wisconsin Oncology Network (WON) clinics between November 2006 and March 2011.|"No events between enrollment and group assignment. All subjects enrolled are immediately assigned to Arm 1, Bevacizumab, Dexamethasone, and Lenalidomide."
754787|NCT00410514||
754788|NCT00410488|Recruitment period: November 27, 2006 to March 22, 2011. All recruitment done in medical clinic at UT MD Anderson Cancer Center.|One participant of the 51 participants recruited withdrew from the trial before assignment to groups and therefore was excluded.
754789|NCT00410423||
754790|NCT00410410|In this study, a first cohort (Induction Period First Cohort, IP1C) of 490 participants was randomized and used for analysis of the primary endpoint. Following randomization of IP1C, a second cohort (IP2C) of 146 participants was randomized to provide a sufficient number of participants for the Maintenance Period.|
754791|NCT00410384||
754792|NCT00410280||
754793|NCT00410202|A total of 629 participants were enrolled at 60 sites.|Of the 629 participants enrolled, 416 were randomized (195 no longer met study criteria, 9 withdrew consent, and 9 had other reason). One participant randomized to entecavir + adefovir (ADV+LVD) Arm withdrew consent before treatment.
754794|NCT00410189|Recruitment period: November 2006 to February 2010. All participants recruited at The University of Texas MD Anderson Cancer Center.|
754911|NCT00403117|A total of 15 males and 14 females completed this study, which used a within-subject design such that each participant received 10 different drug treatments/interventions in total.|
754912|NCT00402987|1 center in the United States.|
754795|NCT00410163||Participants received up to 6 courses (22 weeks) of treatment. After treatment, participants were evaluated for up to 18 months in a follow-up (FU) period and then entered an extended FU phase (up to Month 60). The overall study period reported is from 09 January 2007 to 05 June 2013, when all phases of the study were completed.
754796|NCT00410150||
754797|NCT00410124||Core period was terminated due to early achievements of efficacy targets and patients who were receiving study drug and patients receiving placebo in double blind phase had option to continue into the extension phase to receive open label RAD001.
754798|NCT00410072||669 participants were enrolled; 384 were randomized. Among 285 who were not randomized, 266 did not meet the study criteria, 11 other, 1 poor compliance/noncompliance, 4 lost to follow-up, 1 withdrew consent, and 2 for administrative reasons.
754799|NCT00410059|Recruitment Period: November 29, 2006 to February 4, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.|
754800|NCT00410046|Patients were recruited in Europe from November 2006 to January 2008.|Patients in 0881A3-402 (NCT00247962) were randomized to receive etanercept (ETN) or sulphasalazine (SSZ). After completion, they were eligible for enrollment into this extension study and all patients received ETN. Outcome measure analysis kept the 0881A3-402 assignment of ETN or SSZ. This enabled an analysis of changes from the original baseline.
754801|NCT00409838||
754802|NCT00409825||
754803|NCT00409786||
754804|NCT00409773|"Phase III
~First Patient In 06-Feb-2007:; Last Patient Last Visit 16-Jul-2008
~110 centers worldwide (International, 12 countries)
~Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease."|Patients were randomized to 1 of 5 treatment groups: ezetimibe/simvastatin combination tablet or atorvastatin alone for 6 weeks stratified according to their baseline risk category stratum (high risk patients with atherosclerotic vascular disease or high risk patients without atherosclerotic vascular disease and moderately high risk patients).
754805|NCT00409747|Referrals accepted from community physicians and self(parent) referrals.|Three subjects did not start the drug due to abnormal MRI,initial elevated liver enzymes, and and initial elevated amylase. 11 subjects began taking drug. One subject withdrew after starting drug.
754806|NCT00409708||
754807|NCT00409682|Subjects were enrolled at 45 investigative sites in the US, Canada, and Europe. A total of 192 subjects received at least one dose of adalimumab and participated in the 4-week Open-label induction period of the study. Of these, 4 discontinued and 188 subjects participated in the DB Maintenance period.|Enrolled pediatric subjects were given an induction regimen of 160/80 mg adalimumab at Baseline/Week 2 or 80/40 mg at Baseline/Week 2 according to the subjects' Baseline body weight (BW) and were randomized at Week 4 to receive one of two maintenance regimens of adalimumab every other week (eow).
754808|NCT00409617||
754809|NCT00409578||
754810|NCT00409565||We report results in 46 eligible patients. Two patients were deemed ineligible, one because subsequent biopsy showed that measurable disease was actually steoradionecrosis and not recurrent laryngeal cancer. The other patient required surgery for cholecystitis before starting treatment; this patient never initiated protocol treatment.
754811|NCT00409539||550 subjects were enrolled into the 2 week placebo run-in phase prior to randomization.
754812|NCT00409409|First Patient First Visit 16 DEC 2006, Last Patient Last Visit 12 SEP 2007|
754813|NCT00409344|Recruitment period 10/10/2006 to 1/1/2008 from a surgical intensive care unit in a tertiary hospital.|Unable to enroll participants due to hepatic impairment and many patients taking tricyclic antidepressants.
754814|NCT00409331|Recruitment Period: 06/12/07 through 01/14/08. All participants recruited at UT MD Anderson Cancer Center.|Study terminated due to slow accrual and change in sponsor. Three patients registered, two removed prior to study beginning as not eligible.
754815|NCT00409292||
754816|NCT00409240|Veterans of the Providence VA Medical Center were eligible for the study. Dates of recruitment period were 2007-2009.|
754817|NCT00409188|First/last participant (informed consent): 25 January 2007/31 October 2011. Data cut-off for primary endpoint analysis: 08 August 2012. Participants randomized at 264 centers in 33 countries worldwide.|A total of 1908 participants were screened for eligibility and 1513 participants were enrolled and randomized.
754818|NCT00409175||
754819|NCT00409006||86 participants entered study. 13 participants were screen failures. 73 participants (40 pemetrexed/cisplatin/gefitinib and 33 pemetrexed/cisplatin) were assigned to treatment. 3 participants did not receive study drug. These 16 participants (13 screen failures and 3 that did not receive drug) were not included in the analyses.
754820|NCT00408993||
754821|NCT00408928||
754822|NCT00408902|Patients were recruited from Cleveland Clinic between November 2006 and August 2007.|
754823|NCT00408876||
754824|NCT00408694||
754825|NCT00408681|Patients with severe gastrointestinal acute graft-versus-host disease with or without mucosal denudation identified by endoscopy were recruited from a hospitalized population of patients who had recent allogeneic hematopoietic cell transplantation.|Patients were enrolled according to eligibility criteria in the protocol.
754826|NCT00408629||
754827|NCT00408603||
754828|NCT00408590||
754829|NCT00408564||
754830|NCT00408499||
754831|NCT00408460|Patients that were aged 70 years and above that had never received treatment for metastatic NSCLC were approached for study participation.|
754832|NCT00408434|A total of 32 participants who met all inclusion criteria and no exclusion criteria were enrolled in study from 20 November 2006 to 03 April 2009 at 2 clinic sites in the United States. Of the 32 participants enrolled, 31 participants were dosed and received treatment.|Participants received CS-7017 (0.10 mg to 1.15 mg) every 12 hours. At least 3 participants were treated at each dose level. Dose escalation occurred after at least 3 participants in the current dosing cohort completed 1 cycle of treatment (3 weeks).
754833|NCT00408421||
754834|NCT00408408||
754835|NCT00408317|Participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI) were recruited from centers with CF specialists.|Out of 36 participants who entered the screening period (11 days), and treated with Ultrase® MT20, 31 were randomized to first intervention period.
754836|NCT00408200|Recruitment period: 12/06 to 3/08.|Following consent/enrollment, subject and investigator were blinded to treatment arm until after the ablation procedure. Subjects were later withdrawn if the procedure was not completed, or if a disqualifying medication history or other protocol exclusion was identified.
754837|NCT00408070||
754838|NCT00408005||Patients were stratified between the 2 disease groups (T-ALL and T-LLy) for Induction and then risk assigned treatment based upon the patient's response.
754839|NCT00407966|From December 2006 through June 2008|
754840|NCT00407888||
754841|NCT00407797||A total of 152 subjects were screened and 136 subjects were assigned to study treatment.
754842|NCT00407758|This trial was opened to patient entry on November 6, 2006 and was closed to accrual on May 7, 2007.|
754843|NCT00407745||1 participant was randomized after the first dose of study drug was taken; the participant was randomized to placebo, but the actual drug taken was pregabalin. This partcipant was included in the placebo group for all baseline characteristics and efficacy outcome measures; and in the pregabalin group for overall study and adverse events reporting.
754844|NCT00407654||
754845|NCT00407563|9 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in January 2007 and was completed in December 2008.|Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
754846|NCT00407550|19 patients were enrolled from 9 medical clinics between November 3, 2006 and August 10, 2007.|
754847|NCT00407537|This was a cluster randomized study: the unit of randomization was the investigator, ie, participants were screened before the investigator was randomized. A total of 136 sites were cluster randomized.|Prior to group assignment of investigators (who were the unit of randomization), participants were consented and screened for enrollment eligibility; participant selection for enrollment took place before investigator assignment. A total of 1,531 participants were enrolled and attended baseline visit; 1,461 participants received treatment.
754848|NCT00407511|Subjects were recruited at 13 medical centers in Latin America and participated between January 2007 and July 2008.|160 subjects were screened and evaluated for inclusion/exclusion criteria; 121 were assigned to open-label treatment.
754849|NCT00407485||
754850|NCT00407420||
754851|NCT00407381||
754852|NCT00407355|20 patients with central retinal vein occlusion(CRVO) and 20 patients with branch retinal vein occlusion (BRVO) were enrolled at the Wilmer Eye Institute|
754853|NCT00407030||
754854|NCT00406848||This study had a double-blind one-week placebo lead-in period before randomization, so baseline is defined as Week 1. 370 total patients were randomized and make up the safety analysis population. 299 of these patients were randomized under protocol amendments c, d and e, and make up the efficacy analysis population.
754855|NCT00406783||
754856|NCT00406718||197 signed consents, but only 142 were randomized. 24 no longer wanted to participate, 15 were lost to follow up and could not be contacted, 11 did not meet inclusion criteria once documentation was reviewed, 2 moved out of the area and 3 individuals had family who did not want the individual to participate, leading them to withdraw consent.
754857|NCT00406692|The recruitment period for this study was from May 2007 to April 2008. The primary forms of recruitment were newspaper advertisement and radio advertisement.|
754858|NCT00406653||
754859|NCT00406640|Subjects were recruited in Argentina, Chile, Colombia, Mexico and the United States from December 2006 to January 2008.|Subjects were screened up to 4 weeks.
754860|NCT00406419||
754861|NCT00406393|Participants were enrolled from 2006 to 2011 from 24 different transplant centers.|
754862|NCT00406367||
754863|NCT00406354||
754864|NCT00406315||An additional 14 subjects had a baseline visit but were never treated.
754865|NCT00406276||
754866|NCT00406133|Participants were recruited from within the patient population of the study clinical centers.|Participants completed a run-in phase wearing a blinded continuous glucose monitoring (CGM) device. Eligibility required that a sensor be worn for six out of seven days prior to randomization, with a minimum of 96 hours of glucose values with at least 24 hours overnight, and home blood glucose monitoring be performed at least three times daily.
754867|NCT00406107||
754868|NCT00406029||
754869|NCT00405964||
754870|NCT00405938||
754871|NCT00405912|Recruitment began on 06/01/2006 and completed on 11/08/2007. Interested subjects who passed a phone prescreen were seen at a medical clinic (Mayo Clinic in Rochester, MN and Franciscan Skemp Medical Center in Lacrosse, WI) for consenting and additional study procedures to determine eligibility.|
754872|NCT00405821|440 HIV+ subjects recruited in rural Rakai, Uganda within the Rakai Health Sciences Program mobile medical clinic during May 2007 thru November 2008|All subjects were randomized to study arm, and initiated study treatment at the time of enrollment.
754873|NCT00405756|Data represents a May 11, 2010 data cut-off. The study is ongoing.|Of the 606 subjects screened for this study, 147 failed screening. Reasons for screen failures included: laboratory values not met (45 subjects); diagnostic criteria for measurable multiple myeloma not met (30 subjects); other inclusion/exclusion criteria not met (30 subjects); subject withdrawal of consent (14 subjects); and other (28 subjects).
754874|NCT00405704||
754875|NCT00405652||
754876|NCT00405639|All subjects were recruited from the Mayo Clinic in Rochester, Minnesota.|
754877|NCT00405587||"Enrollment to Dose Escalation: Original Formulation was halted based on bioavailability results and the drug was reformulated as microprecipitated bulk powder (MBP) and then the enrollment was resumed in Dose Escalation: MBP Formulation arm"
754878|NCT00405548|Participants were recruited at the Mayo Clinic in Rochester, Minnesota.|49 participants signed written informed consent to enroll in the study. Of these 8 were withdrawn prior to randomization for varying reasons.
754879|NCT00405522||
754880|NCT00405509|Subjects were recruited from private practice pediatric and family practice offices. Some subjects were recruited via Institutional Review Board (IRB)-approved advertisement.|
755158|NCT00390689||
755159|NCT00390611||
754881|NCT00405392|A total of 365 korean female participants with postmenopausal osteoporosis were enrolled in this study, conducted for 6 months at 15 centers in South Korea.|A total of 365 participants were randomized in the study. Out of the randomized participants 13 were dropped out before administration of drug, remaining 352 participants were included in safety population, 314 participants were included in modified intent to treat population and 308 participants were included in the per-protocol population.
754882|NCT00405353||
754883|NCT00405288|In this multicentre study we recruited pregnant women who were prescribed Proctofoam-HC for hemorrhoids by their physicians and who completed two telephone interviews using two specially designed questionnaires.|There were no significant events that occur before assignment of the enrolled patients to groups.
754884|NCT00405275|Bi-national, multi-center 3.5 year recruitment at 16 VA, 12 RAIN and 8 Canadian medical centers.|
754885|NCT00405067|The study was performed from 30 Jun 2006 to 27 Dec 2006. A total of 6 medical clinics participated in the study.|Patients who were previously on a lipid lowering therapy underwent a 4-week washout period.
754886|NCT00404924|First patient enrolled 08 November 2006, last patient enrolled 09 October 2008, cut off date 19 October 2009. 1168 patients were enrolled in the study.|
754887|NCT00404820|The study was conducted in Germany; first patient enrolled October 2006 and completed December 2008.|
754888|NCT00404768|This study was conducted at multiple centers in the United States, United Kingdom, Singapore, France, Bulgaria, Spain, Argentina, South Korea, and Colombia from 03-December-2007 to 22-June-2011.|
754889|NCT00404755|Recruitment Period: 7/24/2006 - 4/7/2008 Recruitment Location: outpatient research clinic|Patients had to have not taken psychotropic medication for at least two weeks (no fluoxetine for at least 5 weeks) and had to produce a urine negative for commonly abused substances. Current use of psychotropic medication or a positive urine toxicology screen would abort further study participation.
754890|NCT00404651|Participants were enrolled from 14 November 2006 to 13 July 2007 in 6 clinical centers in Mexico.|A total of 1189 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
754891|NCT00404547||The number of subjects STARTED is related to the number of randomized subjects (= subjects who were eligible for treatment period). It differs from the number of subjects of the Intention to Treat (ITT) population in Baseline Characteristics and Outcome Measures. The statistical analyses of the Outcome Measures is based on the ITT population.
754892|NCT00404495||
754893|NCT00404352|The participants were recruited in 78 centers across 28 countries for REFLEX study. REFLEX 12 months open label extension (OLE) was conducted at 11 active centers in 9 countries.|
754894|NCT00404248|subjects were accrued 2007-2008 in outpatient clinic|
754895|NCT00404235||
754896|NCT00404092||
754897|NCT00404079|The trial was conducted at Oslo University Hospital Outpatient Clinic. Recruitment occurred between December 2006 and July 2008 in Oslo Norway, mostly via referrals by general practitioners, physiotherapists, and chiropractors.|Trial participation required no wash out, run-in or transtion phase. Patients were excluded if they fulfilled any of the exclusion criteria.
754898|NCT00404066||
754899|NCT00403845||
754900|NCT00403767|This study, an efficacy and safety study of Rivaroxaban with Warfarin for the prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation, was conducted from 18 December 2006 to 07 September 2010. Patients were recruited at 1,170 study centers located in 45 countries worldwide.|A total of 14,269 patients were randomized in the study. Five patients were randomized twice bringing the number of randomized unique patients to 14,264. A total of 14,236 (7111 and 7125 patients in the rivaroxaban and warfarin groups, respectively) unique patients took at least 1 dose of study medication and were included in the Safety Population.
754901|NCT00403754||A 14 day eligibility screening period insured all participants were stable on their permissible asthma treatment before proceeding onto core study drug treatment.
754902|NCT00403585|Study ADF108005 (NCT00403585; 80 subjects enrolled) is an extension of Study ADF103814 (104 subjects enrolled). For several outcome measures, baseline is defined as the first day of Study 103814; thus, baseline data for 104 subjects are provided, even though 80 subjects were enrolled in Study 108005.|
754903|NCT00403546||Upon signing informed consent participants not already taking ziprasidone were instructed to start open-label ziprasidone for 3 weeks. Of 131 participants who signed informed consent 75 started ziprasidone and 56 were already on ziprasidone. Those completing open-label and those on ziprasidone were then screened.
754904|NCT00403481|Subjects were recruited at 24 US sites over 10 months from November 2006 to August 2007 from each physician's clientele base. Approximately 200 eligible subjects, men and women at least 18 years of age with stage I/II hypertension and stable type 2 diabetes mellitus, were to be enrolled on active treatment.|192 participants started this single arm titration study. Participants remained in their group or were titrated at 3-week intervals depending on achievement their blood pressure goals.
754905|NCT00403455||
754906|NCT00403403||
754907|NCT00403390|Subjects were recruited through flyers in the endocrine clinic and letters with opt-out cards to contact. Recruitment started November 2006 and completed ended March 2010.|Subjects' ages had to be between 3-18 years and had a diagnosis of hypothyroidism, either congenital or acquired with an initial TSH of >100 uIU/mL.
754908|NCT00403273|Of the 194 TKAs (188 patients) screened, 60 TKAs (54 patients) were recruited in the 6-month study. Main analyses were performed only on 49 TKAs, after excluding bilateral TKAs, to meet the assumption of independence of observations.|No enrolled participants were excluded from analyses. Main analyses were done for Single TKA per patient, since 6 were bilateral TKAs; sensitivity analyses were done on all, regardless of unilateral or bilateral
754909|NCT00403234|"Study start date: 02-Nov-2006 (first patient first visit) to 20-Apr-2007 (last patient last visit) at 5 medical/research centers in the US.
~The study was terminated early due to reasons unrelated to efficacy or safety."|"Enrolled: N = 14. Following surgery and recovery from anesthesia, subjects had to demonstrate moderate to severe pain within 6 hours postsurgery (Pain Right Now rating of ≥ 2 on a 4-point scale where 0 = no pain and 3 = severe pain), then their intravenous patient-controlled analgesia morphine device was activated. N = 10 were randomized."
754910|NCT00403130||
755499|NCT00371397|Women were recruited through online ads and notices posted in yoga studios. All women participated in some form of hatha yoga.|
754913|NCT00402896|Recruitment Period: October 2006 to July 2010 at UT MD Anderson Cancer Center included NSCLC participants diagnosed with proven metastatic disease to the pleural space by pleural fluid cytology or pleural biopsy and required IPC placement because of symptomatic recurrent pleural effusions between May 2007 and February 2010.|The clinical trial was terminated before reaching the target patient accrual due to ZD6474 unavailability and of the 28 enrolled but only 20 received treatment. Slow accrual was a contributing factor to early termination.
754914|NCT00402883||
754915|NCT00402831|A total of 411 male and female participants (12 to 18 months of age) were selected for study entry at 33 sites in France. A total of 405 participants were randomized and received 2 doses of study drug.|
754916|NCT00402779|Patients seen at the following sites exhibiting oral leukoplakia we approached and enrolled if interested. These include MD Anderson Cancer Center, Memorial Sloan-Kettering, Emory University,the University of Chicago, and the University of Maryland.|Patients with leukoplakia were screened and, once eligibility was confirmed, patients willing to proceed were randomized to erlotinib or placebo in a double-blinded manner.
754917|NCT00402740|A total of 322 subjects were enrolled in the PROTECT study at 38 clinical sites in the United States. The first subject was enrolled on November 29, 2006, and enrollment was completed on June 18, 2008.|
754918|NCT00402727||834 subjects with complicated skin and skin structure infections (cSSSI) enrolled based on evaluation (by interview, medical history, physical examination, and laboratory tests); 21 subjects not randomized, 668 subjects (361 on moxifloxacin, 307 on pipercillin/tazobactam plus amoxicillin/clavulanic acid) included in primary efficacy analysis.
754919|NCT00402714||
754920|NCT00402688||
754921|NCT00402649|Recruitment was offered to the 23 subjects (aged 2-10 years) who were previously enrolled and assigned to placebo at the three clinical sites in the DMID 04-077 study (NCT00133536), along with up to 32 subjects from a single site who were incorrectly dosed in that study.|
754922|NCT00402597|NCT00402597: Study 39039039ACS2001 (ATLAS ACS TIMI 46 Trial) was conducted at 297 centers in 27 countries between 17 November 2006 and 19 September 2008. A total of 3576 patients were screened for study and 3491 patients were randomly assigned to treatment.|Of the 3576 patients screened for study, 85 patients were screening failures and 3491 patients were randomly assigned to treatment. All randomized patients were included in the intent-to-treat (ITT) analysis set and were eligible for efficacy analyses. Of the 3491 patients, 29 never took study drug, leaving 3462 patients valid for safety analysis.
754923|NCT00402363||
754924|NCT00402337|Patient recruitment occurred over a 13 month period from November 2006 to December 2007 at 57 US study sites.|Patients went through a 14 to 17 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS).
754925|NCT00402324||Study Period 1 was a 2-28 day day period allowing for screening, divalproex treatment initiation (if appropriate) and washout. Patients meeting diagnostic criteria and having therapeutic serum levels of divalproex in target range of 75 to 125 µg/mL (≥80 µg/mL recommended) during Study Period I, will be randomized into either placebo or olanzapine.
754926|NCT00402285|Potentially eligible men identified at Urologic Oncology clinic at Helen Diller Family Comprehensive Cancer Center San Francisco starting in 2003.|
754927|NCT00402246|The first enrollment occurred 29 November 2006. A total of 1997 subjects were enrolled (i.e. consented, implanted, and randomized) in the study from a total of 136 activated clinical study centers.|There were an additional 12 patients (for a total of 2009 patients) consented for whom proper permission to use their data could not be obtained. Any data obtained for these patients was excluded from all reporting.
754928|NCT00402233||There were 312 patients enrolled and 311 patients entered
754929|NCT00402194|Subjects were recruited by word of mouth and flyers posted in key locations on campus.|
754930|NCT00402168||173 participants were enrolled, 2 participants discontinued the study following randomization, without receiving any study drug.
754931|NCT00402116||A total of 12 participants entered Phase 1 of the study. A total of 60 participants were analyzed in Phase 2 for a total of 72 participants for both phases.
754932|NCT00402103||
754933|NCT00402051||136 patients signed informed consent. Of these, 3 patients were discontinued prior to randomization (1x protocol entry criteria not met, 2x patient decision); 133 patients were randomized, 130 patients started study drug.
754934|NCT00402025|Participants were enrolled sequentially into each dose cohort.|
754935|NCT00401973||
754936|NCT00401960||
754937|NCT00401882|Patients in the ventricular tacchycardia refractory to shock with beta blocker|After the patient was refractory to treatment of the Epinephrine the patient would receive medication called Metroprolol
754938|NCT00401843||144 participants were randomized to bortezomib plus placebo group; of which, 3 participants received incorrect treatment (bortezomib plus siltuximab).
754939|NCT00401830||
754940|NCT00401817||
754941|NCT00401778|All enrolled patients were recruited through the multidisciplinary thoracic oncology clinics of Emory Clinic of Emory University.|Eligible patients were enrolled concurrently on the active and control arms. Patient preference for a specific arm was entertained until the control cohort was completely filled after which all patients were competitively enrolled on the active treatment arm of the study.
754942|NCT00401752|Total 219 patients from 18 centers in China who had been receiving a stable daily dose of 1 or more NSAIDs for at least 2 weeks and who had an NSAID-associated GU verified by EGD at baseline were randomized. The first patient was enrolled on 31 Mar 2006, the last patient was completed on 17 Nov 2008.|Total 397 patients from 24 centers in China were enrolled. 178 patients were not randomised due to unwillingness to continue the study or development of any exclusion criteria, etc. Total 219 patients were randomised, 217 patients were included in ITT population.
754943|NCT00401726|Subjects were recruited in the United States from June 2006 to March 2007.|Subjects were enrolled according to the inclusion / exclusion criteria. There was not a screening period.
754944|NCT00401622|Recruitment was conducted at 18 study sites at various locations in the UK (6 Sites), US (10 Sites) and Canada (2 Sites). The first subject was enrolled on 10th October 2006 and the last Subject completed the study on 28th December 2008. Participating sites included family practice centres (US and UK) and hospital based clinical sites in the US.|
754945|NCT00401544|Participants were enrolled from 18 December 2006 through 27 August 2007.|A total of 243 patients were randomizd and 238 received study drug (4 participants in the Darbepoetin alfa 300 μg plus Iron group and 1 in the Darbepoetin alfa 500 μg plus Iron group were not treated)
754946|NCT00401531|Participants were enrolled from 22 October 2006 to 19 November 2007 in 4 clinical centers in Thailand.|A total of 412 participants who met all the inclusion, but none of the exclusion criteria were enrolled and vaccinated.
754947|NCT00401518||
754948|NCT00401414|Warfarin naïve patients undergoing initiation of warfarin anticoagulation at participating Partners anticoagulation clinics, including Brigham and Women's Hospital, Massachusetts General Hospital, North Shore Medical Center, Faulkner Hospital, Spaulding Rehabilitation Hospital, and Newton Wellesley Hospital.|We enrolled patients over 9 months, following each patient for 3 months with twice weekly coagulation testing of the prothrombin time standardized to the International Normalized Ratio, and adjusted monthly the nomogram (if necessary) to improve the fit with emerging data from the cohort.
754949|NCT00401401||
754950|NCT00401375||Postoperative participants (who underwent segmental colectomy via open laparotomy) were randomized in 1:1:1 ratio to MNTX 12 mg, MNTX 24 mg, or placebo treatment groups. Randomization was based on regional stratification.
754951|NCT00401258|Participants were recruited through advertisements|
754952|NCT00401245||A total of 500 participants were randomized to the study, of which 7 were not treated due to other unspecified reasons. A second randomization occurred for the taper phase.
754953|NCT00401193||
754954|NCT00401102||
754955|NCT00400985|501 patients from 41 medical clinics in 13 countries were enrolled between March 4, 2005 and September 9, 2008.|
754956|NCT00400946|Patients enrolled from April 22, 2005 to Dec 13, 2011.|
754957|NCT00400881||
754958|NCT00400829||
754959|NCT00400803|38 Patients with stage IIIb/IV non-small cell lung cancer were recruited at two institutions in Minnesota: Masonic Cancer Center at University of Minnesota and North Memorial Research Center (Hubert H. Humphrey Cancer Center).|Outcome data analysis is only available for 35 of 38 patients in database. Three patients are excluded: 1 never enrolled, 1 has no record of treatment and fup, 1 has no treatment fup.
754960|NCT00400764|The Phase Ib part of this study was completed prior to the start of Phase II. Phase Ib participants were not eligible for participation in Phase II.|
754961|NCT00400712||
754962|NCT00400686|From 9/2003 to 6/2008, a total of 31 patients were enrolled.|
754963|NCT00400634|58 subjects were recruited over a 10.5 month period at 11 centers in the US|
754964|NCT00400569|From September 2006 to August 2007, a total of 48 patients were enrolled on the study by the Moffitt Cancer Center Sarcoma Program. In general, the patients had been heavily pretreated previously, with a significant number receiving more than one prior chemotherapy regimen and most with multiple metastatic sites.|
754965|NCT00400517||
754966|NCT00400439||
754967|NCT00400400||
754968|NCT00400205|Accrual period is from Aug 2006 through Jul 2009. Accrual of 14 patients.|A total of 14 patients with squamous carcinoma were enrolled. All patients had stage 4a or 4b disease and had a performance status of 0-2 then all had measurable lesions on imaging. The study closed prematurely due to slow accrual and increased observed complications.
754969|NCT00400179|This multicenter study was conducted between May 18, 2005 and March 7, 2008 in 24 countries including the United States. Study centers were also located in Canada, Eastern and Western Europe, South America, Australia, and ex-Soviet Union block of nations.|
754970|NCT00400153||
754971|NCT00399893|Participants for the study were recruited over a period of 2.5 years. Participants were identified from the medical clinics or from IRB approved advertisements.|Participants were eligible to enroll into the study with a diagnosis of PWS proven by chromosome analysis and thyroid function tests within normal ranges. Participants could not have used the study drug within the past year and could not have been on steroids within the past 30 days. These items would exclude participation.
754972|NCT00399880||
754973|NCT00399841||
754974|NCT00399802||
754975|NCT00399763||
754976|NCT00399568|Gynecologists and/or anesthesiologists were selected to participate as Principal Investigators.|Subjects were required to meet eligibility criteria prior to surgery and then again had to meet post surgical inclusion criteria.Subjects had to achieve a sufficient pain intensity score prior to entering the study.
754977|NCT00399542|First subject enrolled 05/19/05; last subject observed 08/02/06, at 65 centers across the US|Subjects were enrolled after an up to 4 week screening period to meet inclusion/exclusion criteria and randomized on Day 0
754978|NCT00399529||
754979|NCT00399516||
754980|NCT00399360||
754981|NCT00399308|An enrollment of 55 patients was planned to produce an expected yield of approximately 45 evaluable patients at up to nine study centers.|"72 patients were consented in this study. Eighteen failed screening: eight had HbA1c > 7%; six failed wound size criteria; one was positive for HIV; one had a normal venous ultrasound; and two withdrew consent.
~Of the remaining 54 patients, 14 were not randomized: 11 healed > 50% during screening; one had a severe AE; and two more withdrew."
754982|NCT00399035|Randomised=full analysis set: Cediranib 20mg=502, Placebo=358; Safety set: Cediranib 20mg=500, Cediranib 30mg=214, Placebo=358|"Cediranib 30 mg discontinued following Phase II, Cediranib 20 mg chosen dose for comparing with Placebo.
~1254 patients enrolled to the study, 1076 recieved study treatment; 2 patients lost for Cediranib 20 mg/day, and 2 patients lost for Cediranib 30 mg/day.The 4 patients that didn't receive drug are intentionally included."
754983|NCT00398983|Recruitment Period: 8/28/2006 to 10/15/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.|Of the fifty participants registered, forty-five participants were evaluable. Twenty were randomized to Decitabine 20 mg/m^2, and twenty-five were randomized to no study drug. Five participants withdrew consent or developed complications before assignment of treatment.
754984|NCT00398918||
755028|NCT00396331||Four participants were enrolled in the study but never received plerixafor treatment so are not included below. Reasons for not receiving plerixafor included disease progression (2), infection (1) and insurance issues (1).
754985|NCT00398866|Patients were recruited from the practices of Hospital for Special Surgery (HSS) physicians or were or self-referred. Study information was posted on the HSS website, clinicaltrials.gov, Craig's List and local newspapers. Recruitment occurred between 05/25/2007 and 07/15/2009.|396 subjects screened 169 did not meet eligibility criteria 27 declined injection 200 subjects randomized
754986|NCT00398632||
754987|NCT00398567||
754988|NCT00398476|A total of 127 male or eligible female participants with a diagnosis of allergic rhinitis were enrolled in the study. This study was conducted at 12 investigator sites in the United States. Study duration was '01 December 2006 - 04 December 2006'. Participants included in PP population were 121.|
754989|NCT00398411|First patient in: Oct 10, 2006; Last patient, last visit: Dec 08, 2008|68 patients were intended for inclusion in the trial. Two patients were excluded due to violation of inclusion/exclusion criteria; both received no study drug and they were excluded from the analysis. The remaining 66 participants were evaluable for response analysis in the intention to treat (ITT) set.
754990|NCT00398398||
754991|NCT00398320|Patients were enrolled at one site in the US over a three-year period.|
754992|NCT00398216||
754993|NCT00398138||
754994|NCT00398112|Between August 2007 and December 2008, 18 participants were recruited.|All participants were eligible and included in all analyses.
754995|NCT00398086|Enrollment was initiated in November 2006 and completed in September 2008. Sixty-seven patients were enrolled at four sites in the US.|In Phase 1, patients were assigned sequentially to one of the three potential dose levels based on the dose cohort currently enrolling patients (a total of 30 patients). After the maximum tolerated dose (MTD) was determined, all subsequent patients were enrolled at that dose level in Phase 2 (37 patients).
754996|NCT00398073||
754997|NCT00398047|Three patients were enrolled between 09/14/06 and 01/07/2008. The study was closed for slow accrual on 09/02/2009.|
754998|NCT00397982|Enrollment from Jan 2008 - Feb 2011 at the University of Virginia Cancer Center and Fox Chase Cancer Center.|
754999|NCT00397943||
755000|NCT00397930||
755001|NCT00397904||
755002|NCT00397891||
755003|NCT00397878|Recruitment Period: November 16, 2006 to April 08, 2008. Recruitment done at University of Texas (UT) MD Anderson Cancer Center.|
755004|NCT00397839||
755005|NCT00397813||
755006|NCT00397631|First Patient In: 01-Feb-2007; Last Patient Last Visit: 28-Jun-2008; 60 study sites worldwide.|"Patients ≥18 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (HbA1C
~≥8% and ≤12%) on diet and exercise alone were eligible for randomization."
755007|NCT00397579||
755008|NCT00397540||
755009|NCT00397514|34 patients were recruited between October 1, 2006 and May 31, 2008.|One patient was excluded due to pacing wire malfunction. Four consented but we were not able to adequately capture and pace their left ventricle intraoperatively. Two consented, but underwent early extubation, and we were not able to perform the study in time. One family withdrew from the study. One patient had poor echocardiographic windows.
755010|NCT00397488||
755011|NCT00397462||
755012|NCT00397254||3-month Baseline Period occurred prior to randomization to Clinical Limit or Formulary Limit groups. 42 subjects discontinued from total enrollment of 197: (2) Adverse Event (AE), (10) Lost to Follow Up (LFU), (11) Withdrew consent, (1) Pregnancy, (16) Failed to meet Inclusion/Exclusion at Visit 4 Randomization, (2) Other
755013|NCT00397215||Subjects not previously vaccinated with an influenza vaccine for the 2006-2007 season were administered FluarixTM vaccine intramuscularly at least 3 weeks before administration of the first dose(s) of the GSK1562902A vaccine.
755014|NCT00397189|The first patient entered the study on 24 October 2006 and the last patient completed the study (safety follow up) on 2 December 2008 (last patient completed the last visit on 24 October 2008).|930 patients were enrolled into the study and entered the run-in period; 139 of these patients were discontinued during the run-in period. The main reasons for discontinuation from the run-in were unwillingness to continue and ineligible to continue. Treatment periods were 3 weeks double-blind (DB) (1:1) and extension period 26 weeks DB (3:1)
755015|NCT00397150|Pregnant women are recruited in their communities.|
755016|NCT00397046||
755017|NCT00397033||
755018|NCT00397020||
755019|NCT00396981|Enrollment in the study occurred over 31 months at 26 sites in the US and 17 International. Each site was allowed to enroll up to 60 consecutive subjects; recruitment for the study was competitive. The first subject was enrolled on 29 March 2007 and the enrollment completed on 21 October 2009. A total of 626 subjects were enrolled.|
755020|NCT00396877|Recruitment was initially planned with a minimum of 490 participants anticipating that it would continue until a total of 172 participants reaching primary endpoint criteria is achieved. Finally 906 participants were enrolled and randomized between November 2006 and October 2009 in 134 sites in 31 countries. Actual median follow-up was 5.8 months.|A participant was considered randomized when informed consent had been obtained and there was confirmation of successful allocation of a randomization number through the study treatment allocation system (Interactive Voice Response System).
755021|NCT00396812|10 subjects were to be enrolled into the open label early Rheumatoid Arthritis trial at one site in the US. Enrollment occurred in 2008 but the study was terminated early due to Genentech's announcement regarding rituximab's risk-benefit ratio for individuals with early active Rheumatoid Arthritis.|
755022|NCT00396656||
755023|NCT00396630||Within each pair of twins enrolled in the study, one subject was assigned to the Rotarix Group and one to the Placebo Group.
755024|NCT00396591|17 participants were screened for this study, of which 16 participants were enrolled.|
755025|NCT00396565||Informed Consent was obtained from 394 patients. The actual number of patients randomized in the study was 321. 2 subjects discontinued before treatment. 319 subjects were treated and analyzed for safety. 318 subjects were analyzed for baseline characteristics and efficacy.
755026|NCT00396409||
755027|NCT00396383|Study enrollment began in November 2004 and the study was terminated in May 2007. A total of 20 participants were planned for this study, however the study was terminated early because of insufficient mobilization of CD34+ cells after treatment with plerixafor alone for use in tandem transplants.|
755030|NCT00396292|Hospitals and medical clinics|8 subjects randomized to VIT-45 were discontinued prior to dosing due to subject request (3 subjects), lost to follow-up (2 subjects), 'other reasons' (2 subjects), and physician decision (1 subject). The 1 subject that was randomized to oral iron was lost to follow-up.
755031|NCT00396279|First patient enrolled 10 July 2006; Last patient enrolled 25 January 2008. Results data are reported as of the data cut-off date of 07 April 2008.|
755032|NCT00396266||
755033|NCT00396253||
755034|NCT00396201||
755035|NCT00396162|82 participants were screened . 77 enrolled.|
755036|NCT00396136||
755037|NCT00396097|This was a 4-year, open-label, randomized study conducted at 40 centers across United States of America (USA). The first 2-years of the study constituted core phase and the last 2 years constituted the maintenance phase.|The participants were randomized in 2:1 manner to formula-based dosing arm and standard dosing arm for initial 2 years of treatment, following which the participants in formula-based dosing arm were re-randomized in a 1:1 manner to one of two physiological doses, for next 2 years, to identify the minimum genotropin dosage to maintain the growth.
755038|NCT00396084|Screening for the trial began in February 2004 in Vitória, Brazil. Non-HIV infected adults aged 18-65 years with suspected pulmonary tuberculosis (TB) were recruited at local TB posts and the Hospital Universitario Cassiano Antonio de Moraes of the Universidade Federal do Espírito Santo (UFES) in Vitória. Enrollment was completed in October 2007.|A total of 113 adults with suspected pulmonary TB were evaluated for study participation. Forty-three were excluded because they did not meet the eligibility criteria, leaving a total of 70 patients.
755039|NCT00396032||One participant was randomized but not treated, therefore the modified intent-to-treat (MITT) analysis population was 149.
755040|NCT00396019||
755041|NCT00396006|Participants were recruited at 5 hospital sites in New Zealand and Australia. The period studied was 1 year and 2 months.|21 participants enrolled: 4 were screen failures (i.e., did not meet inclusion/exclusion criteria), 3 were discontinued due to unevaluable baseline bronchoalveolar lavage (BAL) samples, and 1 subject withdrew consent prior to receiving investigational product.
755042|NCT00395993|Hospitals and medical clinics|
755043|NCT00395967|Study enrollment began in April 2005 and the study was terminated in August 2006. Target enrollment was 15 patients, however the trial was terminated early after five patients were enrolled.|
755044|NCT00395876||Three patients were randomized but not treated, therefore the modified intent to treat (MITT) analysis population was 97.
755045|NCT00395863|A total of 47 patients were recruited from March 2007 through February 2008 at 8 clinical trial sites. from Feb/18/2008 to Feb/22/2008, an off-site assessment of the images was performed by 3 board-certified radiologists who were blinded to which contrast agent was used, any patient's clinical information & any results from other imaging studies.|47 patients enrolled (signed informed consent); 46 were randomized and dosed.
755046|NCT00395850|Recruitment occurred between April 2006 and September 2011. Opioid- or nonopioid dependent treatment seekers recruited via newspaper ads, radio ads, flyer, word-of-mouth and referrals and attended the Treatment Research Unit, initially located in an off-campus facility and then relocated to the the Psychiatric Research Institute (12/08).|Participants underwent either a two-week induction onto methadone (if opioid dependent) or a two-week baseline period prior to randomization to the treatment arms and receiving medication starting in week 3. Those receiving at >1 dose of medication and completing assessments at at least 2 time points during week 3 were include in the analyses.
755047|NCT00395746|49 sites in Japan|Subjects included were patients with type 2 diabetes treated with diet therapy and one sulphonylurea (SU) agent (glibenclamide, gliclazide or glimepiride). Subjects continued their current SU therapy with, as a rule, no change in the dose and dosage in the study. A total of 267 subjects were randomised, 3 subjects were not exposed to study drug.
755048|NCT00395733|Participants were recruited at specialized study centers if they satisfied the inclusion and exclusion criteria. All had known or suspected stenosis of arterial vessels in different vascular body regions with an indication for contrast-enhanced magnetic resonance angiography for diagnosis and further treatment.|Of 87 screened participants, 4 were not randomized (2 due to withdrawal of consent, 1 due to entering another clinical study and 1 was lost to follow-up). Thus, 83 participants were randomized to either the sequence Gadobutrol/Gadopentate dimeglumine (41 participants) or Gadopentate dimeglumine/Gadobutrol (42 participants).
755049|NCT00395694||
755050|NCT00395642||
755051|NCT00395629||
755052|NCT00395538|Individuals with hypoparathyroidism were enrolled at the NIH clinical center, beginning in October 2006. The protocol was redesigned and amended in February 2010. Some of the previously enrolled participants were re-enrolled in the new study. New participants were also enrolled on the new study through October 2014.|All participants were put on conventional care therapy for 2-6 months prior to HPTH therapy. Previously enrolled participants had their baseline bone biopsy prior to the study's conventional care period. Newly enrolled participants had their baseline bone biopsy performed at the started of HPTH therapy.
755053|NCT00395512|Participants took part in the study at 268 investigative sites in 23 countries from 02 November 2006 to 13 February 2008.|Participants with a diagnosis of type 2 diabetes who were inadequately controlled with diet and exercise were randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio as follows: Alogliptin alone, pioglitazone alone, alogliptin 25 mg + pioglitazone 30 mg and alogliptin 12.5 mg + pioglitazone 30 mg.
755054|NCT00395486|A total of 613 subjects were enrolled in the study at 13 centres, of whom 258 were randomized to treatment with rosuvastatin (n=132) or atorvastatin (n=126). Subjects were recruited throughout South Korea from September 2006 to June 2008.|Enrolled patients to be randomized should complete 6-week dietary run-in periods. Also, LDL level should be ≥ 130mg/dl & < 220mg/dl and triglyceride should be < 500mg/dl.
755055|NCT00395460|Participants were recruited at specialized study centers if they satisfied the inclusion and exclusion criteria. All had known or suspected central nervous system lesions (including cranial and spinal lesions) with an indication for contrast enhanced magnetic resonance imaging for diagnosis and further treatment.|Of 150 screened participants, 3 were not randomized (2 due to withdrawal of consent, and 1 due to poor physical condition). 147 participants were randomized to either Gadobutrol 0.1 mmol/kg body weight (BW) (72 participants) or Gadopentetate dimeglumine 0.1 mmol/kg BW (75 participants).
755056|NCT00395447||
755057|NCT00395343|"Phase III
~First Patient In: 29-Jan-2007 Last Patient Last Visit: 13-Oct-2008; 100 study centers worldwide"|Patients at least 21 years of age with type 2 diabetes mellitus with inadequate glycemic control (A1C ≥7.5 and ≤11.0%) on stable-dose insulin (alone or in combination with stable-dose metformin) were eligible to enter the 24 week study. 1-week screening, followed by a 2-week single-blind placebo run-in.
755058|NCT00395304||
755059|NCT00395291|We recruited our subjects from 3 clinics at the University of Virginia. Our clinics were located at the Dialysis Units in Charlottesville, VA, Fisherville, VA, and Zion Crossroads, VA. Subjects were recruited into this study between March 2007 and August 2008.|49 Subjects were recruited; 26 Subjects started intervention (4 Subjects started study intervention and then were dropped from the study), 22 Subjects Completed this trial. 1 Subject withdrew their consent prior to study intervention. 22 Subjects did not meet inclusion/exclusion criteria.
755060|NCT00395226|65 participants were recruited between August 2006 and April 2008|"65 participants were assessed for eligibility. 12 did not meet inclusion criteria (severity of facial rosacea greater than mild at the time of enrollment, at least 5 of 12 on the Modified Rosacea Severity Scoring System)."
755061|NCT00395161|Dates of recruitment period: April 2007 - November 2009; Location: Pediatric Intensive Care Unit (PICU)|Patients were stratified according to immunocompromised status prior to randomization.
755062|NCT00395135||
755063|NCT00395083|The pilot study began in July 2006, and trial recruitment began in January 2007 with 6 sites, later expanding to 20. Recruitment ended early in March 2009 due to DMC recommendations.|
755064|NCT00395057||
755065|NCT00395044|50 subjects were recruited. An initial phone screen was conducted followed by an in-person clinical screening and interview in the research laboratory.|Subjects were excluded from enrollment if they did not meet Inclusion criteria or if they met one or more of the Exclusion criteria.
755066|NCT00395018|A total of 109 participants were enrolled at 27 investigative sites.|Of the 109 participants enrolled, 65 were treated and 61 received therapy for at least 1 month. Of the 44 participants who were never treated, 23 no longer met study criteria, 9 due to administrative reason by sponsor, 6 withdrew consent, 3 due to other reasons, 2 died, 1 due to poor/non-compliance.
755067|NCT00394953|The study was conducted from 20 December 2006 to 27 November 2008 in Europe along with Canada and Australia. A total of 490 eligible participants were enrolled.|Out of 490 participants, one did not receive the study drug and was excluded from the safety population.
755068|NCT00394914||All enrolled participants were screened. After the screening visit and before randomization, participants received weekly phone calls and revisited the site once per month during a Pre-exposure Period until exposed to a household member with a cold (index case).
755069|NCT00394901|Fifty (50) centers in Japan|After a 1-week baseline phase, subjects were stratified into 1 of 2 strata based on their creatinine clearance (CLcr) values (Low, 30 <CLcr <=60 mL/min or Normal, CLcr > 60 mL/min) and then equally randomized into 1 of 4 treatment groups.
755070|NCT00394888||
755071|NCT00394836||Participants were randomized to one of two ofatumumab dose arms. Disease progression and treatment refusal resulted in some participants entering early follow up after early withdrawal from study treatment. They are being followed for overall survival.
755072|NCT00394771||A total of 988 subjects were screened for participation in this study, and 567 took at least one dose of investigational product (Safety population).
755073|NCT00394706|Clinical sites enrolled patients during a run-in period with the first patient enrolled on June 7, 2007. The run-in period ranged from from 2 to 6 months across the sites. The last patient was enrolled in the evaluable phase on November 6, 2009. All patients were enrolled in the pre-hospital EMS setting.|
755074|NCT00394654|Thirty patients were entered into the study between 16Oct2006 and 15Aug2007 at 2 sites in Canada.|Treatment assignments were determined using a block randomization procedure with a 1:1 ratio through an interactive Web response system (IWRS). Patients who were randomized into the study but did not complete the second allergen challenge on Day 7 were replaced, unless the patient withdrew for safety reasons.
755075|NCT00394589||
755076|NCT00394524|4 hospital centers between April 2006 and August 2008.|Of 160 enrolled, 80 were randomized to each group. Among the 80 subjects in glucommander group, 1 died prior to starting infusion and 2 were excluded because of meeting exclusion criteria for the protocol. Among 80 subject in standard group 1 withdrew consent prior to starting infusion and 3 met exclusion criteria. 153 were analyzed
755077|NCT00394472||
755078|NCT00394433|Patients (n=38) were enrolled between September 2006 and March 2008.|
755079|NCT00394355||
755080|NCT00394329||
755081|NCT00394277||
755082|NCT00394251|Multicenter study|Two hundred three patients were randomized and one hundred ninety-seven were treated.
755083|NCT00394212|Subjects were recruited at bariatric centers of excellence with screening initiated on 25Oct2006. The first randomized procedure was performed on 3Apr2007. The last subject follow-up was performed 8May2009.|Prior to enrollment, prospective candidates having provided informed consent were screened for eligibility during a formal 6 week screening period. Screening performed by a multidisciplinary team including surgeon and/or endoscopist, psychiatric professional and registered dietician.
755084|NCT00394095|Thirty one bipolar adolescents with a manic or mixed episode (ages 12-18 years) were recruited from the inpatient units and outpatient clinics at the University of Cincinnati and Cincinnati Children's Hospital Medical Center.|Subjects meeting the entry criteria were randomized to treatment with topiramate or placebo in combination with olanzapine for this 12-week study.
755085|NCT00394082||
755086|NCT00393978||
755087|NCT00393939||594 participants enrolled in study; 1 participant withdrew consent prior to treatment. In accordance with French law, that participant's data was not used in the analyses.
755088|NCT00393913|Normal volunteers and patients with symptoms of sleep apnea evaluated at the NYU sleep disorders center.|Subjects with sleep disorders other than sleep apnea were not included for initial assessment of the effect of sleep apnea severity to daytime function.
755089|NCT00393887||
755090|NCT00393874||
755091|NCT00393861||This protocol was based on getting at least 18 evaluable patients. Since the response data had looked promising, an additional 11 patients were added to obtain more accurate estimates of response.
755092|NCT00393848||
755093|NCT00393796|Participants were originally randomized to SUTENT or Placebo (Double Blind Period). 26 participants were randomized to SUTENT. Of the 28 participants randomized to Placebo, those that progressed were offered SUTENT if they were eligible.|
755094|NCT00393718|75 sites in Japan.|Subjects included in the study were patients with type 2 diabetes treated with diet therapy only or diet therapy and one OAD (Oral Anti-Diabetic Drug). Subjects on OAD therapy discontinued their current treatment during the run-in period (Weeks 4-6 before dosing). A total of 411 subjects were randomised, 11 subjects were not exposed to study drug.
755095|NCT00393705||
755096|NCT00393523|"This study was conducted at 77 primary study sites in Spain and 1 study site in Canada.
~Date of first subject visit: 26-Sep-2006; Date of last subject visit: 23-June-2008"|To be eligible for enrollment in the study, participants were to have received a primary series of 3 doses of the same type of hepatitis B vaccine (either RECOMBIVAX HB or ENGERIX-B) during the first year of life.
755097|NCT00393510|Apr 2002 to Apr 2006, Orthopaedic Department, Prince of Wales Hospital, HK Apr 2002 to Apr 2006, Orthopaedic Department, Kwong Wah Hospital, HK|Liver Function and Renal Function test normal. Patients suffering from serious cardiac and renal deficiencies were excluded from the study because of safety measure.
755098|NCT00393484||A total of 122 participants were enrolled in this study; 2 did not receive treatment.
755099|NCT00393458||
755100|NCT00393380|Thirteen patients were enrolled on the study between October 25, 2006 and March 27, 2008 from three centers. Dana Farber Cancer Institute enrolled 10 patients, University of Florida enrolled 2 patients and Massachusetts General Hospital enrolled 1 patient.|Thirteen patients who were enrolled proceeded to the cord blood transplant.
755101|NCT00393367||
755102|NCT00393094||
755103|NCT00393068||
755104|NCT00393042|Eligible participants were recruited from the investigators' practices, clinic referrals, and radio advertisements. Participants were enrolled between January 2007 and January 2009.|7 participants didn't want to participate after screening, 1 didn't meet criteria, 1 ADHD was not the primary condition, 1 showed an abnormal lab/physical/EKG, 1 was unable to swallow pills, 1 had an exclusionary medical condition, 1 was removed due to protocol violations.
755105|NCT00393029|Expect to enroll 4-5 patients of each allowed histology up to a total of 82 patients. Approximately two years may be needed to accrue the maximum number of required patients.|
755106|NCT00392990|The study opened for accrual on October 4, 2006 with the first patient enrolling and starting treatment on February 6, 2007 and an accrual goal of up to 25 patients. The study was closed permanently on April 26, 2011 to further accrual with 25 patients enrolled on the study.|"Patients were stratified as either high-risk or low-risk.
~Low Risk= patients with normal Lactic acid dehydrogenase (LDH) level, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, Ann Arbor stage as I or II and no tumor mass over 10 cm in greatest diameter.
~High Risk = All other patients"
755107|NCT00392951||
755108|NCT00392925|30 October 2006 started Lead-in Period. 20 September 2007 final visit. Study conducted at clinics with obese patients (body mass index [BMI]greater than, equal to [≥]30 to less than, equal to [≤]35 kg/m^2) or overweight patients (BMI ≥27 to <30 kg/m^2) and abdominal obesity = waist circumference >102 centimeters (cm) for males; >88 cm for females.|177 participants enrolled into single blind lead-in period with pramlintide treatment and a diet, 38 withdrew before double blind randomization into 1 of 3 treatment arms. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups.
755109|NCT00392860|Subjects were recruited from November 7, 2008 to April 8, 2009.|The manufacturer of the PalmRim decided not to pursue the design and development of the product. As a result, the PalmRim experiment arm did not enroll any participants.
755110|NCT00392834||
755111|NCT00392821||
755112|NCT00392808|Recruitment was done in primary care pediatric clinics, between january and may 2007.|
755113|NCT00392782||
755114|NCT00392769|Recruitment Period: October 10, 2006 to January 25, 2010. All recruitment done in a medical clinical setting.|
755115|NCT00392704||
755116|NCT00392678|3 private practices and 14 universities. First patient recruited February 2007; last patient end of study visit, May 2008|Screening, followed by 4-week single mask placebo lead-in. 277 participants signed screening consent. Some participants were ineligible, some withdrew consent, and some had treatment side effects during placebo lead-in.
755117|NCT00392665||
755118|NCT00392496|This trial was centrally activated on November 8, 2006 and closed to accrual on March 24, 2009. Patients were recruited from 5 cancer centres in Canada|
755119|NCT00392444|This study was centrally activated on November 10, 2006 and the study was closed to accrual on September 10, 2010. Patients were recruited from 9 cancer clinics in Canada|
755120|NCT00392392||
755121|NCT00392379|The study was conducted at the Mayo Clinic in Rochester, MN, and the Oregon Research Institute (ORI) in Eugene, OR. Enrollment took place between January, 2007 and April, 2008. Smokeless tobacco (ST) users were recruited through press releases and advertising from the surrounding communities.|
755122|NCT00392327|Patients (Pts) 3-21 yrs were recruited at COG institutions.The first pt was enrolled 5/23/2007, and the last pt was enrolled 4/9/2018.The study was initially open to medulloblastoma and supratentorial primitive neuroectodermal tumor (SPNET) pts, but closed for SPNET pts as of amendment #2.All pts were off treatment at the time of results reporting.|Participants received standard therapy consisting of surgery, radiation and chemotherapy. A subset of patients was randomly assigned to receive carboplatin. A second randomization was used to randomly assign patients to receive isotretinoin. Of note, the isotretinoin randomization was stopped early due to futility.
755123|NCT00392288|Screening period 7-14 days, randomization with subsequent treatment period over 12 weeks|The number of subjects in section Participant Flow is related to the number of randomized subjects (= subject who were eligible for treatment period). This number is different to the number of subjects of the Intention to Treat (ITT) population in Outcome Measures. The statistical analyses of the Outcome Measures is related to the ITT population.
755160|NCT00390572||A total of 156 subjects were consented and enrolled in the study, but 15 were excluded before randomization for not meeting entry criteria and 4 withdrew because they found study procedures too demanding. The remaining 137 continued in the study and were randomly assigned.
755124|NCT00392236|The study had 2 phases. Phase 1 was devoted to testing the Electronically Assisted Medication Adherence (EAMA) system. All subjects received the EAMA system during Phase 1. Phase 2 was a randomized trial comparing EAMA with treatment as usual. The main focus of this report is Phase 2.|The open label phase 1 of the study was designed to refine the pager intervention . Seventeen subjects completed baseline assessments, pager training and phase 1 study procedures. Data presented under Participant Flow are for the group of subjects who participated in the the randomized phase 2 of the study.
755125|NCT00392223||
755126|NCT00392210|271 potential subjects were identified. 192 declined participation so 79 were enrolled.|10 subjects were withdrawn prior to randomization
755127|NCT00392197||
755128|NCT00392171||
755129|NCT00392054|Eligible consenting patients from 16 sites in Canada and Europe were randomly assigned 1:1 to the Catheter Ablation arm or Antiarrythmic Drug Therapy arm. The randomization schedule was computer generated and stratified by site with variable block size.|
755130|NCT00391989||
755131|NCT00391976||123 patients were enrolled and received tobramycin 300 mg twice a day for 28 days. Patients who received treatment but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into one of the two treatment groups but were followed-up during routine clinic visits.
755132|NCT00391898||
755133|NCT00391872|The first participant was enrolled on 11 October 2006 and the last participant completed the study on 27 February 2009. Study participants were randomized from 855 centers in 43 countries.|Participants will already be hospitalized due to their acute condition, and must be enrolled and randomized within 24 hours of the onset of their most recent cardiac ischemic symptoms. Randomization should take place as soon as possible after presentation.
755134|NCT00391846|This was a randomised, parallel group, single blind, multicentre, 9-month study in chronic heart failure in patients with New York Heart Association classification of heart failure (NYHA) class II-IV, left ventricular systolic dysfunction and elevated NT-proBNP levels in the primary care setting.|"At visit 1 was the NT-proBNP value measured at this value should be above 800 (females) or 1000 (males) before randomisation at visit 2. One patient from each group are excluded from the full analysis set (FAS) due to total unavailability of efficacy data after randomisation."
755135|NCT00391807|Recruitment period 01 Nov '06 thru 24 Aug '08|
755136|NCT00391768|Patients were recruited from the emergency department, hospital, physician's office or clinical care unit. Children of both sexes and all races were included. The recruitment period was January 2007 through May 2010.|
755137|NCT00391716||
755138|NCT00391625|The first patient was enrolled on 3 February 2005.|Recruitment of patients was limited to those patient who completed first in man, Phase I/II study TKT025, elected to continue to receive treatment with velaglucerase alfa and met the study inclusion criteria.
755139|NCT00391599|The inclusion criteria were elective cesarean section and no history of previous abdominal operations except for cesarean delivery.|
755140|NCT00391586|Recruitment began 07/13/2006 and ended 02/09/2009. All patients were recruited through medical clinics in New Mexico, USA.|
755141|NCT00391469||
755142|NCT00391443||
755143|NCT00391391|Study participants ere enrolled from 19 October to 12 December 2006 in 20 clinical centers in the US.|A total of 517 of the 520 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
755144|NCT00391365|"474 patients were assessed for eligibility with 368 consenting to participate in the study.
~95 subjects were excluded for various reasons (no surgery, non-compliant, etc.) resulting in 273 subjects actively participating.
~229 subjects successively completed the Year 3 follow-up assessment."|
755145|NCT00391274||
755146|NCT00391222|This study was run from 14 November 2006 to 13 April 2009. Patients were recruited at 70 investigational sites located in 14 countries across Europe, Asia, Latin-America, and Africa.|Patients were treated appropriately or continued previous treatment. At baseline, treatment with Risperidone Long Acting Injectable (LAI) was started. During 12 weeks patients were stabilized on risperidone LAI and treatment with antipsychotics, mood stabilizers and other psychotropics was titrated off unless otherwise specified in the protocol.
755147|NCT00391118||Part 1: Unblinded, single cohort safety lead-in of enzastaurin (enz) with paclitaxel (pac)/carboplatin (carb). Part 2: Randomized, double-blind, placebo-controlled trial consisting of: Baseline, Chemotherapy (start of study drug to discontinuation of pac and carb), Maintenance (day chemotherapy ends to study completion), Follow-up (up to 3 years).
755148|NCT00391092||The participants were randomized 1:1 using a block design randomization procedure with stratification (for prior adjuvant/neo-adjuvant taxane, trastuzumab as part of adjuvant treatment versus no trastuzumab, estrogen/progesterone receptor hormone receptor status and measurable disease) to avoid an imbalance of important prognostic factors.
755149|NCT00391079||
755150|NCT00391053|Participants were enrolled from 09 October 2006 to 21 December 2006 at 30 US sites.|A total of 3851 participants who met the inclusion and exclusion criteria were randomized and vaccinated. The vaccine received by 14 participants could not be verified, they were excluded from all analyses except immunogenicity analysis. 4 participants that started the study, but had no post-vaccination assessment were also excluded from analysis.
755151|NCT00391027||Number of subjects randomized = 261; number of subjects treated (out of 261 randomized) = 257.
755152|NCT00390949|Study participants were recruited from six pairs of sub-communities matched on socio-economic criteria|
755153|NCT00390910|For each subject the study duration was approximately 5 months for the active phase (Month 0 untill one month after last vaccination) and 10 months, including the 5 months extended safety follow-up.|During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
755154|NCT00390884|Participants were enrolled into this study from 03 October 2006 to 04 January 2007 at 5 US clinical centers.|A total of 173 participants were enrolled, vaccinated, and analyzed.
755155|NCT00390858||
755156|NCT00390806||
755157|NCT00390780|Recruitment from 25 July 06 to 27 December 07 A total of 30 clinical sites (private practice and hospitals) in US, Canada and South Africa screened patients for this study, and 28 sites randomized patients|There were no significant events or approaches following participant enrollment and prior to group assignment
755161|NCT00390559|Recruitment via media advertisement and flyer. Recruitment began 9/14/2005 and ended 1/30/2008.|Enrolled (i.e., consented) participants were excluded if they failed to meet safety criteria (e.g., blood pressure) measured after the informed consent was given.
755162|NCT00390546|Patients were enrolled between December 2006 and August 2010. 14 centers enrolled study participants. Only 72 of the desired 220 subjects enrolled. Enrolment closed early as an independent, unblinded verification of the results determined that a much larger sample size than estimated was necessary to demonstrate the primary outcome existed.|
755163|NCT00390468|Recruitment at UT MD Anderson Cancer Medical Clinic from October 24, 2006 to January 8, 2008.|Participants must have had at least one prior taxane based regimen but no prior known Platelet Derived Growth Factor Receptor (PDGFR) inhibitor therapy was permitted.
755164|NCT00390455|Between September 2006 and July 2010, 295 participants were recruited.|
755165|NCT00390429||
755166|NCT00390416||
755167|NCT00390364||
755168|NCT00390325|November 2006 and January 2008|
755169|NCT00390299||
755170|NCT00390234||
755171|NCT00390221||
755172|NCT00390182|All patients with cancer are seen by a multi-discipline clinic (medical, surgical, radiotherapy, etc). The PI or Co-PI identifies eligible candidates and initiates the discussion of research participation.|
755173|NCT00390013||"Study has 2 phases:
~first was a placebo controlled randomized study (4 participants) second was a cross-over study (5 participants - 2 did not cross over)"
755174|NCT00389974||
755175|NCT00389857|Subjects were recruited from 13 October to 13 December 2006, at a single site in the US.|A total of 31 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated.
755176|NCT00389831||
755177|NCT00389818||
755178|NCT00389805||
755179|NCT00389597|One Level TDR Arm: 169 subjects randomized (5 not operated) One Level ACDF Arm: 87 subjects randomized (6 not operated) Two level TDR arm: 232 subjects randomized (7 not operated). Two Level ACDF Arm: 115 subjects randomized (10 not operated)|1 level TDR enrolled 184 incl15 training cases (2 withdrew consent, 1 AE, 2 other). 1 level ACDF enrolled 87 with no training cases (4 withdrew consent, 2 other) for 245 randomized subjects. 2 level TDR enrolled 241 incl. 9 training cases (1 withdrew consent, 6 other); 2 Level ACDF enrolled 115 with no training cases (4 withdrew consent, 6 other)
755180|NCT00389532|Study participants were enrolled from October through December 2006 in 1 medical clinic in the US|A total of 116 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
755181|NCT00389519|Study was conducted from October 2006 to November 2007 at 56 international sites|Subjects entered placebo run-in prior to randomization
755182|NCT00389493|A randomized clinical trial (conducted January 2007-August 2012) at 2 academic outpatient research clinics that specialize in OCD and anxiety disorders. Patients (aged 18-70 years) were eligible if they had OCD of at least moderate severity despite a therapeutic SRI dose for at least 12 weeks prior to entry.|
755183|NCT00389467|From 2004 to 2011, participants were enrolled at 22 sites with expertise in acute stroke care, imaging and interventional neuroradiological procedures. Eligible patients presenting within 8 hours of symptom onset were enrolled. The study website generated a randomized treatment assignment using a penumbral pattern code based on brain imaging.|Randomization was stratified by favorable penumbral or non-penumbral pattern based on on-site analysis of baseline multimodal MRI or multimodal CT. While 127 subjects were enrolled, only 118 of these subjects qualified for the primary analysis per discussion with the DSMB as 9 subjects enrolled did not actually meet full eligibility criteria.
755184|NCT00389441||
755185|NCT00389324|First Patient, First Visit: Nov. 21, 2006, Last patient, Last visit: Aug. 26, 2008. This study was performed at medical clinics.|
755186|NCT00389207||
755187|NCT00389168|Multicenter Swedish study. Patients with primary hypertension and left ventricular (LV) hypertrophy.|"All participants received a placebo washout period during 4 weeks at the beginning of the study.
~One patient of the 115 included was during the course of the study diagnosed with Mb Conn (adrenal tumor causing endocrine secondary hypertension). This patient was excluded from all analyses. Thus, there are 114 patients included in the dataset."
755188|NCT00389064|International multi-center study, 47 sites recruited between Sept 2006 and Apr 2008|Screening for eligibility and wash-out of restriced medications
755189|NCT00388973|International multi-center study, 53 sites recruited between Sept 2006 and Dec 2007|Screening for eligibility and wash-out of restricted medications. At least moderate depression symptoms assessed by the Hamilton Rating Scale for Depression
755190|NCT00388947|The first patient was registered in September 2006, The last patient data were entered in May 2010.|Patients had to met all of the inclusion criteria and none of the exclusion criteria.
755191|NCT00388804|Recruitment period: 02/16/2005 to 09/08/2010. All recruitment was at UT MD Anderson Cancer Center.|Of the 39 enrolled participants, one participant was excluded from the trial before assignment to groups.
755192|NCT00388726|This study was recruited at 135 centers in 19 countries during the period of Nov 2006 to May 2009.|
755193|NCT00388674||Overall, 12,522 participants were enrolled;12,485 participants were randomized; and12,378 participants received treatment. 100 participants were never treated with the study medication; 3 participants were at participant's request; 2 participants were not reported; 1 participant was administrative reason by sponsor; and 1 was other.
755194|NCT00388583|Participants were enrolled from 28 September 2006 through 30 May 2007 in 16 clinics in the US|A total of 816 of the 817 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on the 807 participants that completed the study are presented.
755195|NCT00388505||
755196|NCT00388453|Volunteers for all three groups were recruited from the Vanderbilt Medical Center|
755197|NCT00388414||
755198|NCT00388362||
755199|NCT00388349||
755243|NCT00385944||A total of 56 patients received a clopidogrel loading dose (LD) of 900 mg and were then randomized to receive a maintenance dose (MD) of either 10-mg prasugrel or 150-mg clopidogrel. Two patients withdrew from the study after randomization but prior to receiving a MD, one due to subject decision and one due to physician decision.
755200|NCT00388297|This study enrolled women with a singleton pregnancy before 20 weeks gestation who met the criteria for either subclinical hypothyroidism or hypothyroxinemia based on serum thyrotropin and free T4 values. The study was conducted as two multicenter, randomized, placebo-controlled trials at 15 NICHD MFMU network centers.|97,228 patients were screened during the recruitment period October 2006 to October 2009, Of the 800 eligible based on subclinical hypothyroidism, 677 completed the 7-day placebo adherence run-in and were randomized. Of the 632 eligible based on hypothyroxinemia, 526 completed the run-in phase and were randomized.
755201|NCT00388154|Recruitment Period: August 20, 2004 to December 19, 2008. All recruitment done within medical clinic settings at MD Anderson Cancer Center, St. Luke's Episcopal Hospital and The Woman's Hospital of Texas.|
755202|NCT00388037||
755203|NCT00387959||
755204|NCT00387894||
755205|NCT00387881||
755206|NCT00387829||A total of 343 patients were randomized in the study (Intent-to-treat population). Four patients received treatment (1 Duragen Plus; 3 Surgery alone), but were not randomized correctly, and were followed-up for safety only. Hence the total patients in the Safety Population is 347.
755207|NCT00387790||
755208|NCT00387764||
755209|NCT00387751||
755210|NCT00387725||
755211|NCT00387712|Veterans with chronic hemiparetic stroke (latency > 6 months) were recruited from the Baltimore VA and University of Maryland Neurology and Primary care clinics, as well as through Institutional Review Board approved flyers and ads.|Reasons for participant exclusion were not meeting eligibility criteria, screen failures (ischemia on stress test or serious lab abnormalities) new medical conditions, study time requirements, return to work, lost to follow-up, lack of transportation.
755212|NCT00387673||
755213|NCT00387660|The recruitment period was 6 years. Subjects were recruited at 4 large medical centers.|
755214|NCT00387647|Researchers consented 29 potential participants between 08/02/0206 and 11/01/2011. 24 eligible participants began treatment, one at Duke University Medical Center and 23 at Moffitt Cancer Center.|
755215|NCT00387621|The study took place between February 2006 and August 2009. All subjects were consented and were seen at the Mayo Clinic in Rochester, MN.|63 participants were enrolled in the study, but 5 participants were excluded because they did not meet inclusion criteria. Participants included normal controls, Preclinical Systolic Dysfunction, and Preclinical Diastolic Dysfunction subjects, who were randomized into Placebo First, then Nesiritide (Arm A) and Nesiritide First, then Placebo (Arm B)
755216|NCT00387465||49 subjects did not start the study due to screen failure or PI decision.
755217|NCT00387426|Recruitment Period: September 14, 2006 to December 17, 2007. All recruitment done at UT MD Anderson Cancer Center.|
755218|NCT00387348|Participants were recruited from the ambulatory thoracic and GI cancer clinics at MGH. Recruitment was open from 11/1/06 until 4/1/11.|After enrollment, participants completed an assessment for major depressive disorder. 90 participants consented for study evaluation. In order to be randomized to a group, participants had to meet criteria for major depressive disorder. Of the 90 evaluated on study, only 24 were randomized.
755219|NCT00387335||
755220|NCT00387244||
755221|NCT00387153||
755222|NCT00387127||
755223|NCT00387088||
755224|NCT00387036|"Patients were recruited from 1 center in Canada.
~Patient screening began 14-Dec-2006 and the first patient was randomized on 16-Feb-2007.
~Last patient last visit for the study was 31-Jul-2009."|Patients must have met the following criteria: FEV1 (Forced expiratory volume in 1 second) less than or equal to (≤) 70% and FEV1/ FVC (forced vital capacity) ≤ to 0.7; FRC (functional residual capacity) greater than or equal to (≥)120% of the predicted value, and moderate to severe chronic activity-related dyspnea ≥ 120% of the predicted value.
755225|NCT00387023|All recruitment done at The University of Texas (UT) MD Anderson Cancer Center between August 2004 and November 2007.|
755226|NCT00387010|A total of 327 patients with chronic pain and breakthrough pain (BTP) were screened for enrollment into this study. Of the 327 patients screened, 218 patients at 31 centers in the US met entry criteria and were considered eligible for enrollment into the study.|
755227|NCT00386880||
755228|NCT00386776|We recruited patients from the Healthcare Associates (HCA)and the Affiliated Physicians Group (APG) clinics of Beth Israel Deaconess Medical Center who were to see their primary care physician for the first time.|Forty-five patients enrolled in the Computer-based medical history study. Forty of these patients started the medical history and 32 of these patients completed the program.
755229|NCT00386724||
755230|NCT00386607||
755231|NCT00386477||
755232|NCT00386425||Efficacy results are only provided for the intent-to-treat (ITT) population (patients who actually received the randomized treatment after the 24 hour pretreatment period).
755233|NCT00386360|Screening started 3 April 2006|
755234|NCT00386334||823 participants were screened. Two participants in each arm completed all assessments for the double blind period but discontinued before starting the follow up period (withdrew consent; did not take any single blind medication in follow up period).
755235|NCT00386308||
755236|NCT00386256|Subjects were recruited from both the inpatient and outpatient settings of a large urban academic VA hospital. Potential participants were recruited through referrals from physicians, case managers, and social workers, participant recruitment fairs, and flyers posted around the hospital.|
755237|NCT00386243|Enrollment began December 2007 and concluded June 2011. The final assessment was completed by May 2012. All subjects were recruited from the Roudebush VA Medical Center.|
755238|NCT00386152||Number of participants randomized:- epoetin alfa (80,000 Units): 77, epoetin alfa (120,000 Units): 80, darbepoetin alfa (500 mcg): 78; Number of participants treated:- epoetin alfa (80,000 Units): 75, epoetin alfa (120,000 Units): 77, darbepoetin alfa (500 mcg): 75.
755239|NCT00386100||
755240|NCT00386022||
755241|NCT00386009||
755242|NCT00385996|The recruitment period was from 10/13/06 to 10/8/08. Patients were recruited from the Weill Cornell Medical College Thoracic Surgery outpatient office.|
755349|NCT00380718||Thirty-seven participants were screened; 3 did not meet inclusion/exclusion criteria and one withdrew.
755244|NCT00385918|Dates of recruitment: April 2007 through 2010. Location of recruitment: Kernan Hospital Spinal Cord Injury Clinic and Baltimore VAMC Spinal Cord Support Clinic.|Participants all underwent baseline and feasibility testing prior to randomization in either of the two arms.
755245|NCT00385840||
755246|NCT00385827||
755247|NCT00385801|Participants were recruited from October 2005 to September 2006 via advertisement in local press|After baseline evaluation participants began treatment with oral risperidone, 1 mg per day the first week and 2 mg per day for the next 3 weeks. Electrocardiograms were repeated after 1 and 2 weeks of risperidone use. Participants with corrected QT interval (QTc) prolongation greater than 470 milliseconds at either of these occasions were excluded
755248|NCT00385788|Recruitment Period: July 14, 2005 to June 26, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.|First cohort (n=12) was treated before addition of Gemcitabine in the preparative regimen.
755249|NCT00385762||
755250|NCT00385736||
755251|NCT00385723|Data collection for this double-blind placebo-controlled four month randomized clinical trial began in September, 2006 and ended in February, 2011. Ohio State University campus and community print and web-based announcements were used for recruitment.|We used participants' ability to follow the regimen as a criterion for study entry. Participants received a 7-day supply of placebo capsules (single blind) at the subsequent in-person screening session, and those who had taken less than 80% of the capsules a week later were dropped before randomization.
755252|NCT00385684||
755253|NCT00385671||
755254|NCT00385593|654|
755255|NCT00385580||130 participants were enrolled in the study; 95 participants entered the treatment period. 67 discontinued due to disease progression, 13 for study drug toxicity, 5 for other reasons, 4 withdrew consent, 2 for adverse events unrelated to the study, 2 requested discontinuation, 1 due to death, and 1 due to maximum clinical benefit.
755256|NCT00385541|Adults having general surgery at Columbia University Medical Center (CUMC) were randomly assigned to receive Patient-Controlled Analgesia (PCA) with morphine or hydromorphone|Double blind randomized controlled trial. Patients under 18, with chronic pain or on pain medication before surgery were excluded.
755257|NCT00385515||533 subjects were screened during a chemotherapy cycle and those that developed ulcerative oral mucositis and fully recovered were randomized to treatment with study drug during the next chemotherapy cycle
755258|NCT00385268||
755259|NCT00385255||Out of the 1726 subjects originally enrolled in this study, 8 subjects (7 subjects from the 19-64 years of age cohort and 1 subject from the 65 years of age cohort) did not receive the study vaccine and hence were not included in the Total Vaccinated Cohort.
755260|NCT00385216||
755261|NCT00385203|Enrolled: 45mg GIST=26, 45mg STS=10; Full analysis set: 45mg GIST=25, 45mg STS=10; Safety set: 45mg GIST=24, 45mg STS=10. 36 patients were enrolled and 35 patients were randomized. One GIST patient consented but had an adverse event and was withdrawn from the study before they were randomised.|
755262|NCT00385138|"Patients were selected for randomization based on the need for percutaneous coronary intervention (PCI).
~Randomization could only occur after the need for PCI was confirm by angiography."|
755263|NCT00385008|This study was conducted at a single site in the United States during 13 September 2006 to 24 November 2006. TREXIMA® tablet was a fixed dose combination of sumatriptan succinate 119 milligrams (mg) (equivalent to 85 mg of sumatriptan) and naproxen sodium 500 mg.|First ten participants enrolled received TREXIMA and the next ten enrolled received Relpax. In each group, the first 5 participants who had a migraine and who were able to attend the clinic received the extra dose of the respective treatment.
755264|NCT00384956|Enrollment to the study started on 08/17/2006 and enrollment to the study closed on 06/10/2008.|
755265|NCT00384930||Prior to randomization, participants had a 1-4 week Screening/Wash-out Period, followed by a 4 week Placebo Run-In Period. 1813 participants were screened with 755 screen failures, and 1058 participants randomized. The two participants who did not receive study drug were not included in the baseline demographics table.
755266|NCT00384865||
755267|NCT00384839||
755268|NCT00384813|Families were recruited from an urban hospital and a residential camp for children with asthma. Initial eligibility criteria : (a) residence in one of two urban counties, (b) child age 8 to 13, (c) Medicaid or State Children's Health Insurance Program, (d) current prescription of a daily controller agent, and (e) poorly controlled asthma.|Caregivers of children meeting initial eligibility criteria were interviewed briefly by phone; those answering affirmatively to either of two stress questions were invited to participate in a Screening Assessment. Caregivers with an elevated score on a stress measure were invited to participate in the trial.
755269|NCT00384774||
755270|NCT00384748||
755271|NCT00384670||
755272|NCT00384449||
755273|NCT00384397|Participants were enrolled from 20 September 2006 to 29 September 2007 at 71 US clinical centers.|A total of 1118 participants were enrolled, vaccinated, and included in data analysis.
755274|NCT00384332|Participants referred by treatment providers.|
755275|NCT00384293||There was an MK0524A active run-in period prior to randomization. Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, for an additional 4 weeks prior to randomization.
755276|NCT00384241|A study record search was completed on 500 youth for inflammatory marker Interleukin 6 (IL-6), genetic polymorphism and stress induced urinary sodium secretion data. 599 parents of identified subjects were asked to submit Buccal swabs for the analysis of IL-6 genes.|
755277|NCT00384189|Participants took part in the study at 110 investigative sites in Bulgaria, Germany, Hungary, Poland, Romania, Russia, South Africa, Spain, and Ukraine from 29 September 2006 to 17 August 2007.|Children with a diagnosis of asthma were enrolled equally in 1 of 4 treatment groups, once a day placebo, 40 µg, 80 µg or 160 µg ciclesonide.
755278|NCT00384176|Enrolled = 1814 though not all patient randomised. Randomised= Intent to treat (ITT): Cediranib 20mg 709, Cediranib 30mg 192 Bevacizumab 713; Safety: Cediranib 20mg 705, Cediranib 30mg 191 Bevacizumab 704|"Cediranib 30mg discontinued following Phase II, Cediranib 20mg chosen dose for comparing with Bevacizumab.
~200 patients dropped prior to treatment. Study was set up as a phase II/III study. Participants were enrolled into both phases if they participated in both Phase II/III, but are only counted once in the Enrollment Number and in the Results."
755279|NCT00384085|A total of 123 study sites were activated in the United States; 99 sites enrolled and randomized 588 patients from May 2006 to March 2010. 582 patients out of 588 patients were treated. Three sites (which included 26 patients) were found to be non Good Clinical Practices (GCP) compliant.|Patient were considered enrolled after informed consent were obtained, and randomized after completion of the 4-week run-in phase and assessment of the randomization criteria.
755280|NCT00384059|Participants were recruited in the United Kingdom (UK) from October 2006 to June 2007.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
755281|NCT00384033|Study was conducted from 27 September 2006 to 28 September 2007 in United States (US) only.|A total of 925 participants were screened for this study and 638 participants were randomized. The remaining 287 participants were not randomized due to screen failures.
755282|NCT00383942|Recruitment for the trial opened at Loyola University Medical Center (Maywood, IL) on 08/31/2006 and closed on 06/05/2008.|There are no pre-assignment details
755283|NCT00383786|Patients (aged 18-65) were recruited from media advertisement (86%) or clinician referral (14%). Diagnoses were made with the SCID-IV performed by an experienced research clinician, along with an independent interview by a psychiatrist. A primary diagnosis of chronic PTSD, signifying an illness duration.|Of 235 potential participants screened for eligibility, 171 (73%) were excluded prior to placebo lead-in. 128 did not meet eligibility criteria, 24 were lost to follow-up, and 19 withdrew consent. Sixty-four patients began placebo lead-in, of whom 47 patients (73%) were randomized (11 were ineligible and 6 withdrew consent).
755284|NCT00383760||
755285|NCT00383747|Non-smoking adults with a DSM IV diagnosis of schizophrenia or schizoaffective disorder, depressed type, were recruited from an urban community mental health clinic. Non-smoking adults without psychiatric illness were recruited using advertising in local press and internet sites. All study procedures took place between January 2005 and July 2006.|Once enrolled, participants attended a baseline visit followed by 2 study days. At the first visit, subjects underwent a training session in the Cognitive Drug Research battery and subjects with schizophrenia completed baseline clinical scales including the Scale for Assessment of Negative Symptoms (SANS) and Positive and Negative Syndrome Scale
755286|NCT00383721||At Week 26, all participants randomized to placebo were to be discontinued, while 75% of participants randomized to an active treatment were randomly selected to participate in the 26-week Treatment Safety Extension. Several placebo-treated participants continued in error into the Treatment Safety Extension.
755287|NCT00383708|The study was a multicentre, open, single arm, sequential study where subjects were recruited to 25 study centres across 10 European countries. Subjects were enrolled to the study from 02 October 2006 (first subject enrolled) until 27 October 2008 (last subject completed).|A total of 125 patients were screened. Subjects were assigned to treatment if they met all inclusion and none of the exclusion criteria. 92 subjects received treatment during the run-in period and 57 subjects received treatment during the co-administration period.
755288|NCT00383643|Subjects were recruited through local newspaper ads and from the Stanford Sleep Disorders Clinic. A general description of the study was provided. Preliminary screening was conducted by telephone. Interested and qualified persons were scheduled for an in-person screening visit.|
755289|NCT00383630||
755290|NCT00383565|Recruitment Period: September 20, 2006 to May 08, 2009. All recruitment done at UT MD Anderson Cancer Center.|
755291|NCT00383552||
755292|NCT00383500|Enrollment commenced in May 2005 and concluded 13 March 2012. Subjects were recruited from the medical clinics and Stanford University Hospital and Clinics.|
755293|NCT00383448||
755294|NCT00383435||"At Week 26, all participants randomized to placebo were to be discontinued, while 75% of participants randomized to an
~active treatment were randomly selected to participate in the 26-week Treatment Safety Extension. Several placebo-treated participants continued in error into the Treatment Safety Extension."
755295|NCT00383331||
755296|NCT00383292|Interim analyses of pharmacokinetic (PK) data resulted in adjusted dosing populations to achieve desired concentrations of study drug within the targeted range.|Study completion was defined as a participant completing 2 cycles of treatment and end of Cycle 2 radiographic assessment of response.
755297|NCT00383266|The study opened to participant enrollment on 10/11/2006 and closed to participant enrollment on 11/12/2009.|
755298|NCT00383240||
755299|NCT00383162||
755300|NCT00383149||Of the 58 participants enrolled, 4 were never treated.
755301|NCT00383123||"Two subjects, enrolled in the Fluzone Group, were not vaccinated; therefore, they were not included in the number of subjects included under STARTED."
755302|NCT00383110|Patients were recruited from the Charleston VAMC. Veterans with Type 2 Diabetes identified through the VA electronic medical resources system (CPRS) were consented and enrolled between November 2004 and February 2006.|
755303|NCT00383084||
755304|NCT00383071||
755305|NCT00383019|55 centers in Japan|300 subjects were treated with Xalatan in Run-in period. (Run-in period: subjects treated with Xalatan (0.005% latanoprost eye drop), one drop, once daily in the evening (20:00-23:00).) Of these, 289 subjects were assigned to groups (144 in KP2035 group and 145 in Xalatan group).
755306|NCT00382993||
755307|NCT00382967||
755308|NCT00382928|One hundred and ninety two patients were recruited in the time period between 10/10/2006 to 7/20/2007 to the telemetry ward of the Atlanta VA Medical Center.|
755309|NCT00382863|Subjects were recruited from 29 investigational sites in the US and 6 investigational sites in Canada, between November, 2006 to September, 2009|3 subjects were considered Roll-in (not randomized) and received treatment. Data from these subjects are not included in the results. Seven (7) subjects were randomized to the Treatment group but were not treated due to suspension of the study. These subjects are excluded from the data.
755310|NCT00382824||
755311|NCT00382785|Subjects were recruited via flyers, word of mouth, at clinics, and via university electronic news. Participants were recruited from August 2005 through December 2008.|
755350|NCT00380692||Study Period I was a screening and wash-out period. Study Period II (visits 2-6) was an 8-week double-blind period. Patients were randomized at Visit 2. Study Period III (visits 6-11) was a 20-week open-label extension period. Treatment groups in Study Period III refer to treatment group assignment during Double-Blind Period.
755351|NCT00380588||
755312|NCT00382733|The study was open to enrollment at one community oncology clinic from November 2006 to May 2009.|Informed consent was obtained from all subjects. All subjects underwent a screening period that could last up to 4 weeks during which pre-study assessments were completed. During the dose finding portion of the study, subjects were assigned to a Dose Level during enrollment. Once the MTD was determined, additional subjects were treated at the MTD.
755313|NCT00382720|A total 275 participants from 12 countries were randomized in the part I/II study. 64 participants were enrolled in Part I. 211 new participants were enrolled specifically for Part II.|The intent-to-treat (ITT) population, included 254 participants randomized to the optimal dose of study medication from Parts I (43) and II (211), and excluded 21 participants administered the non-optimal dose in Part I.
755314|NCT00382590|Recruitment Period: 09/20/05 through 11/01/06. All participants recruited at UT MD Anderson Cancer Center.|Eleven (11) patients were registered, one (1) patient was not eligible and was taken off study prior to receiving study drug.
755315|NCT00382408|The study was conducted in subjects undergoing military basic training.|Participants were randomized to either the vaccine group or the matching placebo group in a 3:1 ratio.
755316|NCT00382291|The study was performed at two child and adolescent psychiatric clinics within university medical centers: Gainesville, Florida (FL) (UF) and Tampa, FL (USF). Recruitment started in early 2009 and ended in late 2010.|Fifteen participants were excluded after screening: 7/15 did not meet inclusion/exclusion criteria and 8/15 withdrew consent.
755317|NCT00382265||
755318|NCT00382174|Recruitment started in 2005 and ended in 2008 using 13 sites: Medical Center Clinics, Wound Care Center, Veteran Administration Centers, and Clinical Research Centers.|Prior to randomization, patients needed to meet specific inclusion and exclusion criteria: results of pregnancy tests needed to be negative; glycosylated hemoglobin tests needed to be less or equal to 8.5% of the total hemoglobin.
755319|NCT00382148||
755320|NCT00382109||
755321|NCT00382031||
755322|NCT00382018||624 patients were registered for screening. 29 patients were excluded due to initial CTC test not completed(17) and ineligible(12). 276 did not have increased CTC levels (Arm A). 319 patients had increased CTC levels. Additional 31 patients were excluded from 319 due to no CTC values on Day 21. Thus total 288 patients in ArmB, ArmC2 and ArmC2.
755323|NCT00381966||
755324|NCT00381940||
755325|NCT00381888||
755326|NCT00381862||
755327|NCT00381849|Patients with recurring and analytically confirmed kidney stones were recruited from the Mayo Stone Clinic in Rochester, MN.|
755328|NCT00381810||
755329|NCT00381797||
755330|NCT00381706|Between September 2006 and May 2009, 245 participants were enrolled and randomized.|Twenty three (23) participants had squamous cell carcinoma were excluded from the analysis.
755331|NCT00381693|Ten patients were recruited from August 2006 to December 2007 at Mayo Clinic. This trial was permanently closed in December 2007 due to lack of accrual and it demonstrated too little clinical benefit.|
755332|NCT00381680||
755333|NCT00381641||
755334|NCT00381628||
755335|NCT00381615|Subjects were enrolled at three study centers in the United Kingdom (UK).|All enrolled subjects were included in the trial.
755336|NCT00381563|Subjects will be recruited through: public media including the Boston Metro, Community News, Baystate Banner and Tab, Craigslist; patients referred from BMC rheumatology, primary care, physical therapy, and orthopedics & from Baptist Hospital orthopedic clinics, and persons already recruited from studies whose consent forms allow contact|
755337|NCT00381550|Patient's presenting for treatment of a myeloproliferative disease were considered for participation.|Once patient consented to treatment, treatment began shortly there after.
755338|NCT00381485||834 participants enrolled in the open-label Run-In Period, of which 728 participants were randomized into 1 of 3 arms. Of 728 randomized participants, 643 participants overall completed the Treatment Period, while 85 participants overall discontinued investigational treatment early. All randomized participants received ≥1 dose of study medication.
755339|NCT00381381|This study was recruited at 15 centers in Korea during the period of June 2006 to August 2008.|
755340|NCT00381303||
755341|NCT00381238|The study was conducted from 20 June 2006 to 03 February 2009, at seven centers in Canada and United States. This was an extension study, with a total of 33 participants with mild to moderate Alzheimer's disease, recruited in the study, who had completed 12-months of treatment in 49653/461 study.|
755342|NCT00381095|A0081128 terminated on 01-SEP-2010 due to slow enrollment, analysis at 50 percent (%) enrollment determined that increasing the sample size would require significant extension of enrollment period.|
755343|NCT00381043||
755344|NCT00381004|Recruitment Period: September 20, 2006 to June 5, 2008. All recruitment done at The University of Texas MD Anderson Cancer Center.|
755345|NCT00380978|Between October 2001 and December 2006, women presenting at Prentice Women's Hospital for induction of labor and who desired neuraxial analgesia were eligible to participate. Patients were asked to participate by study personnel after admission to the Labor and Delivery Unit and gave written informed consent before request for analgesia.|A total of 1,026 women consented to participate. 208 women were excluded because cervical dilation was 4 cm or more at the first analgesia request. Twelve participants were excluded after randomization because they did not receive the allocated intervention and outcome data were not available. The remaining 806 women were included in the analysis.
755346|NCT00380874||Of the 69 subjects screened, 64 were randomized, and 61 received treatment. Of the 8 subjects screened but not treated, 1 was ineligible due to an abnormal laboratory test result, 6 were ineligible due to a reason categorized as other, and 1 was no longer willing to continue in the study.
755347|NCT00380861|There were eight clinical investigators participating in the investigation. Subjects who were to receive simultaneous bilateral knee replacement were recruited for this study, where one knee was to receive the PFC Sigma Rotating Platform high flexion (RP-F) device and the other knee was to receive the PFC Sigma Rotating Platform (RP) device.|The randomization was a two stage scheme in order to minimize bias that could potentially be introduced due to differences in preoperative range of motion (ROM) between a subject's right and left legs.
755348|NCT00380744||Participant Flow reports participants who discontinued from the study.
755352|NCT00380393||
755353|NCT00380367|"First Patient In (FPI): 03 May 2007 Last Patient Out (LPO): 04 Feb 2008
~Multi-center study. Seven sites participated in the study. All sites were medical centers located in Bangalore, Mumbai and Pune."|Open-label, single-arm, nonrandomized study. Females >9 to 15 years of age, who have not had coitarche and did not plan on becoming sexually active through the course of the study, who did not have a feverish feeling within 24 hours prior to the first injection, were included in the study.
755354|NCT00380250|First subject entered 5/12/05; Last subject observation 7/18/08; Multicenter study performed at 65 study sites/centers across the US|Subjects were enrolled after an up to 4 week screening period to meet inclusion/exclusion criteria and randomized on Day 0
755355|NCT00380081||A total of 83 patient volunteers were enrolled and of these, 82 patients were randomized, received at least 1 dose of study drug during the double-blind treatment period and were included in safety and efficacy analyses.
755356|NCT00380068|Enrollment occurred between September 2006 and January 2008 and the study was conducted between August 2006 and May 2009 in 39 centers in the United States, Australia and Canada|The screening period was 4 weeks. Participants who received bosentan or sitaxsentan within 4 weeks prior to the screening visit were excluded.
755357|NCT00380029||27 patients were screened, 23 patients were consented to the study; three of these patients were not subsequently enrolled due to ineligibility (1) and patient decision not to enroll in the trial (2).
755358|NCT00379912||
755359|NCT00379899|Participants were enrolled from 27 October 2006 through 2 May 2008|
755360|NCT00379834|10 subjects enrolled from WVU Eye Institute between April 2006 and April 2008|No patients excluded at any time
755361|NCT00379821|Children who were brought to the Ndirande Health Centre with symptoms suggestive of malaria were recruited from February 19, 2007 to August 13, 2008.|
755362|NCT00379808|Patients were recruited based on flyers posted in public places, through recontact of patients in previous studies, and patients cared for in a family medicine clinic|
755363|NCT00379795|This is an open label multicenter extension study for participants who have completed one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823). Cohort 1 includes patients with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD).|Participants were classified according to ranibizumab exposure in the previous study and in the extension study. 63 participants (Untreated Group) did not receive study drug in this extension study or in the previous studies and are not included in the safety analyses.
755364|NCT00379769|The RECORD study ran from April 2001 through December 2008. Results are presented in the non-re-adjudicated outcome measures (OMs). An independent patient-level re-adjudication of mortality, non-fatal myocardial infarction, and non-fatal stroke began on January 2011 and ran through March 2012. The results are presented in the re-adjudicated OMs.|The RECORD observational follow-up (OFU) started at the end of the RECORD study and ran through December 2012. OFU was designed to collect cancer and bone fracture data. Participants were not provided with study medication in the OFU. Data are presented for the entire study (RECORD + OBF) and for OFU alone in the observational OMs.
755365|NCT00379639||"Patients were assigned to 1 of 2 dose schedules concurrently on an every-other-patient basis using a 3+3 dosing scheme: Patients in Schedule A received study treatment Days 1, 8, and 15 and those in Schedule B on Days 1 and 15 of every 28-day cycle. Patients were observed for 28 days before enrollment at the next dose level, based on toxicities."
755366|NCT00379587||
755367|NCT00379574|Duration of patient enrollment: From 15-Dec-2006 to 02-May-2009|
755368|NCT00379353|Recruitment Period: 10/18/2006 through 10/27/2008. All participants recruited from UTMD Anderson Cancer Center.|The trial is now closed to new participant entry due to low accrual. Of the 31 participants recruited, 4 were not eligible for evaluation.
755369|NCT00379340||The 15 discrepant patients were ineligible to the study. They were excluded in the Participant Flow table because none of them were treated by the protocol and their group designations were unknown.
755370|NCT00379288||Subjects starting study are those subjects who completed screening procedures and randomized.
755371|NCT00379236||A total of 821 patients were screened.
755372|NCT00379210|PI Laboratory at the University of Pennsylvania Round 1 of recruitment February 1-15, 2007 Round 2 of recruitment September 7-21, 2008|Participants ages and gender were matched across groups. Significant prior experience with meditation or current or past neurological disorder or metal in body (for FMRI safety) were used as exclusion criteria
755373|NCT00379197||
755374|NCT00379145|This trial was opened to patient entry on June 4, 2007 and was closed to accrual on November 3, 2008.|
755375|NCT00379080|Patients enrolled from 4/2007 through 6/2010. Patients accrued in the outpatient clinical setting. The first part of study was for patients who required surgery. Hence these patients were treated in-patient.|
755376|NCT00378898|Subjects were 18 years of age or older and scheduled for esophagogastroduodenoscopy (EGD) and wireless pH testing for physiologic assessment of esophageal acid exposure for typical gastroesophageal reflux disease (GERD) symptoms such as heartburn and regurgitation or for extra-esophageal reflux symptoms such as cough or asthma at Vanderbilt.|
755377|NCT00378703|Participants were recruited from ECOG member institutions between September 14, 2007 and December 10, 2010 with a final accrual of 361 patients.|
755378|NCT00378599||
755379|NCT00378573||
755380|NCT00378560|Study was conducted at 14 sites in Japan from 2006 to 2009.|There were no specific criteria.
755381|NCT00378534||
755382|NCT00378508|Subjects were recruited from 4 clinical sites and were eligible if they were between the ages of 8-30 and diagnosed with Type 1 Diabetes for at least 4 months, but not more than 12 months prior to enrollment.|
755383|NCT00378378||
755384|NCT00378352|Conducted at 28 US sites between October 2006 and February 2010 and included 222 patients with STEMI who underwent successful percutaneous coronary intervention (PCI) as a primary or rescue reperfusion strategy|
755385|NCT00378326||
755386|NCT00378209|65 eligible participants were enrolled from the 6 institutions in the United States between September 2006 and April 2008 and 64 out of 65 received protocol treatment.|Participants screened over a 3 week period.
755536|NCT00369343|Patients were recruited in the United States from September 2006 to September 2007.|Patients were screened over 4 weeks.
755537|NCT00369317||
755538|NCT00369278||
755387|NCT00378105|A total of 68 patients were enrolled in the United States. For the phase I part, this study enrolled 33 eligible patients between Sep13, 2006 and Aug16, 2007. For the phase II part, this study enrolled 35 eligible patients between Aug 20, 2007 and Feb18, 2008.|Participants were screened over a two-week period.
755388|NCT00378079|See publication in Journal of Substance Abuse Treatment (2009), 37, 277-285.In summary, participants were recruited between September 2003 and June 2005 from male prisoners in a Baltimore pre-release facility. They had to have met criteria for methadone maintenance treatment in the year prior to incarceration.|See above
755389|NCT00378014|The core study consisted of 2 periods: 1) during the first one-month period, 276 eligible participants received the same CNI-based immunosuppressive therapy prior to randomization; 2) during the second 11-month study period, 203 participants eligible participants were randomized in a 1:1 ratio to one of the two treatment arms.|
755390|NCT00377962|This was a 12-month study in maintenance heart and lung transplant patients with a follow-up period of an additional 12 months. Results to 24 months are presented. Patients were randomized to continue their current calcineurin inhibitors (CNI) based regimen or to start everolimus with reduction of CNI blood levels.|
755391|NCT00377858||636 patients were screened; 128 were screen failures; 24 discontinued prior to randomization; 484 patients were randomized. Baseline Characteristics are provided for the Intent to Treat Population, which was defined as patients with baseline and at least one post-baseline value.
755392|NCT00377832|Dates of recruitment 9/2006 until 12/2010 13 patients recruited No funding|All participants included in assigned groups
755393|NCT00377819|First Subject Enrolled: 02-Oct-2006 Last Subject Enrolled: 07-Mar-2007|
755394|NCT00377741|A total of 31 participants were included from 5 centers in the United States of America. This study was conducted between 01 December 2004 and 30 June 2006.|Participants were received 900 mg of commercial medication of valganciclovir tablet daily for >= 4 days prior to study Day 1 so as to achieve steady-state kinetics of ganciclovir.
755395|NCT00377676|Patients were recruited from 74 centers across the United States and Puerto Rico, including 19 Veterans Affairs (VA) hospitals. First patient enrolled: 23 August 2004 Last patient completed: 25 January 2007|4,074 subjects were screened, 3,095 randomized 2:1 to Cycloset or placebo. 3,095 were analyzed for safety and 3,070 for all other analyses.The most common reason given for screen failure due to protocol ineligibility was an elevated creatinine (24.7% of all screen failures).
755396|NCT00377637|The induction phase was a prospective, randomized, open-label, active controlled, parallel group, international multicenter, 2-arm comparison study of MMF versus IVC in inducing a response in patients with Lupus nephritis. Responders in the induction phase were re-randomized into a double-blind, double-dummy, active controlled Maintenance Phase.|
755397|NCT00377611||
755398|NCT00377572||
755399|NCT00377520||
755400|NCT00377455||
755401|NCT00377429||
755402|NCT00377403||
755403|NCT00377364|This randomized, double-blind, placebo-controlled study was conducted at asthma and allergy clinics on the UT Southwestern Medical Center campus.|Those with prior psychiatric symptoms during corticosteroid therapy were not excluded.
755404|NCT00377312|Starting in October 2006, 19 Healthy caucasian males & females between 24 - 35 yrs were screened. By November 2007 11 subjects were randomized and 10 completed the one week infusion study which was done on the Clinical and Translational Research Clinic (CTRC) at the University of Pittsburgh Medical Center (UPMC).|Candidates were non-smokers and females had negative pregnancy tests. Those on chronic medications with the exception of oral contraceptives or stable thyroid hormone replacement were excluded. Body mass index had to be less than 30, and all had normal screening labs.
755405|NCT00377299|Sixty depressed outpatients with methamphetamine dependence were enrolled and randomized for 12 weeks of acute treatment after completing an IRB-approved written informed consent The study was conducted at the UT Southwestern Medical Center in Dallas. The first participant was enrolled on 10/11/06 and the final assessment was on 4/7/09.|
755406|NCT00377260|Children were recruited over 3 respiratory seasons, beginning on 11/31/2006 with the last enrollment on 3/31/2009. There were 2 enrollment sites, as well as referrals from private pediatricians. One site was a large private practice; the other was a large hospital based practice. This was for generalizability.|There were 2 children who signed consents but were not randomized. One parent withdrew consent and one child, referred from an outside practice, was found to not be eligible.
755407|NCT00377234|Of the 488 patients who were screened, 356 patients were enrolled into the study at 44 centers in the USA and randomized to treatment with ibandronate and risedronate. One hundred eighty patients were randomized to Sequence A (Period 1 ibandronate, Period 2 risedronate), and 176 patients to Sequence B (Period 1 risedronate, Period 2 ibandronate).|
755408|NCT00377156|At 34 institutions in North America, patients with 1 to 3 brain metastases were randomized to receive SRS or SRS plus WBRT between February 2002 and December 2013. 70 patients accrued by ACOSOG Z0300 were included in the power calculation and also included for this study.|
755409|NCT00376961||
755410|NCT00376948||
755411|NCT00376935|Study participants were recruited at 22 sites around the States, between February 2007 to April 2008.|All randomized participants got at least one injection on each of three consecutive days.
755412|NCT00376805||
755413|NCT00376688||
755414|NCT00376675|One-hundred and forty-eight (148) participants were recruited between February 2008 and August 2008 from 20 North Central Treatment Group (NCCTG) member sites.|There were a total of 8 cancellations (5 Methylphenidate, 3 Placebo) and 1 ineligible participant on Placebo. These 9 participants were excluded from all analysis.
755415|NCT00376597||
755416|NCT00376558||
755417|NCT00376532|Subjects with Implanted Cardiac Defibrillators were enrolled from the Heart Institute Outpatient Clinic or from the inpatient Electrophysiology Lab at Thomas Jefferson University Hospital|
755418|NCT00376506||
755419|NCT00376363|A total of 276 patients were enrolled between November 2005 and April 2008: 143 in the Ahmed group and 133 in the Baerveldt group at 16 clinical centers worldwide.|
755491|NCT00371683||3608 patients enrolled and 3195 were randomized to double blind (DB) Treatment Period: 413 not randomized due to: 227 no longer met criteria, 109 withdrew consent, 60 other reasons, 11 administrative reason by sponsor, 5 adverse event, 1 poor, non-compliance.
755492|NCT00371644||
755493|NCT00371631||
755420|NCT00376259|Planned enrollment was 150 patients. At the time of study termination, 43 patients had been enrolled and randomized to study treatment and 42 patients received study drug (21 patients in the combination group and 21 in the monotherapy group).|One patient was randomized but never received study drug treatment because he was discontinued on the randomization day due to sponsor request.
755421|NCT00376246||
755422|NCT00376220||
755423|NCT00376168||
755424|NCT00375999||
755425|NCT00375973||
755426|NCT00375934||
755427|NCT00375830||
755428|NCT00375752||
755429|NCT00375713|506 patients were screened and 466 randomized. Due to a packaging error 99 patients were excluded from the efficacy analysis according to the advice of the Korean FDA. The Reported Adverse Events section refers to the Safety Population (N= 423) defined as all patients treated with at least one safety evaluation without entry criteria violation.|Participant workflow refers to all randomized subjects whereas in Baseline Characteristics numbers and statistics for the modified Intent To Treat (m-ITT) population are presented (see definition of m-ITT population in the Outcome Measure section).
755430|NCT00375674|Of 674 enrolled participants (615 in global cohort and 59 in china cohort), the results presented refers to the study conducted on 615 (intent-to-treat population) in 21 countries and were randomized to sunitinib and placebo for 9 cycles (1 cycle=42 days).|Screening: From Week 0 (nephrectomy surgery) to Week 11; in this period, echocardiogram/multi-gated acquisition, post-surgery imaging, histopathology, physical examination, laboratory tests, electrocardiogram and concomitant treatment were assessed. Randomization occurred not before 3 weeks post-nephrectomy & not after 12 weeks post-nephrectomy.
755431|NCT00375609|Between 10 May 2006 and 12 February 2007, 215 patients were enrolled. After undergoing unilateral total knee replacement surgery, patients were randomized to 1 of 3 treatment groups (2:2:1 allocation). The study was open-label for randomization to enoxaparin versus betrixaban, but the 15 mg versus 40 mg dose of betrixaban was double-blind.|Patients scheduled to undergo elective primary unilateral total knee replacement (TKR) surgery were evaluated for eligibility 1 to 30 days before surgery (Screening). Consenting subjects who remained eligible for the study after TKR were randomized. 215 patients were randomized and all but 1 received at least 1 dose of study drug.
755432|NCT00375518||
755433|NCT00375505||
755434|NCT00375492||"One randomized patient per group discontinued before receiving study drug. These patients are not included in the started category below."
755435|NCT00375427|Total enrollment was 430; five participants were screened but not treated.|
755436|NCT00375219||
755437|NCT00375167|Managers of 2 ACT teams reviewed all clients to identify those eligible for study between August and October 2006. Eighty-one identified and informed about the study, with 34 people providing informed consent. Clients were grouped by team and then randomized to one of the two arms. One person dropped out at time of randomization|Participants were grouped according to team prior to randomization because the group intervention was administered by team
755438|NCT00374907||156 participants were enrolled in the study; 110 participants failed screening; 10 subjects entered lead-in and discontinued prior to randomization.
755439|NCT00374868||A total of 59 participants entered the trial (21 in Phase 1 and 38 in Phase 2). Phase 1 determined the dose for Phase 2 to be 400 mg/m^2. Phase 2 results are reported.
755440|NCT00374842|A total of 300 subjects were enrolled in the study. Study duration was of approximately 1 month (30 days) for all subjects.|
755441|NCT00374803|Single center, 45 patients consecutively enrolled. Patients were randomized into two groups: (group 1) will be receive 2160 mg/day for two weeks, followed by 1440 mg/day thereafter, and (group 2) will receive 1440 mg/day for the duration of the study.|
755442|NCT00374556||105 were assessed for eligibility. 75 were excluded based on not meeting inclusion criteria. 30 were randomized to one of 2 arms. One subject after randomization ( to placebo condition) was determined to be ineligible due to failing sleep apnea entry criteria. They were removed from the study and did not contribute to baseline data.
755443|NCT00374543|Numerous attempts were made to increase enrollment since study inception. Researchers made use of Radio, Internet and print ads, as well as weekly Internet postings. Researchers also circulated an IRB-approved GAD checklist in a Bipolar Clinic waiting area in order to increase enrollment and recruit a clinically relevant sample.|A total of thirteen individuals signed consent, but only three were randomized to the study arms. The other ten participants were excluded from the study for meeting various exclusion criteria.
755444|NCT00374452||The study initially involved 5 medical centers with 103 participants across the medical centers. One of the 5 medical centers completed installation of ATHENA-HTN system, but did not continue with the intervention period, so the intervention included 4 medical centers with 82 participants.
755445|NCT00374335||
755446|NCT00374322|Women with early-stage ErbB2-overexpressing breast cancer who had not been previously treated with trastuzumab were enrolled in this Phase III study. Women who subsequently had no clinical or radiologic evidence of disease were enrolled after completion of primary neoadjuvant/adjuvant chemotherapy.|The study consisted of a Screening Period, a 1-year Treatment Period, and a Follow-up (FU) Period of up to 5 years after the date of study drug withdrawal/completion, for disease status/survival. A total of 3161 eligible participants (par.) (of the 3166 enrolled) were randomized, out of which 3147 par. received at least one dose of study treatment.
755447|NCT00374244|This clinical trial was conducted at the outpatient clinics of the West Haven VA, Connecticut Mental Health Center of Yale Department of Psychiatry, and the Zucker-Hillside Hospital of Long Island Jewish Health Care System, and approved by the respective Institutional Review Boards.|Prior to randomization, a stable dose of clozapine for the past 2 weeks with a blood level of at least 350 ng/ml was targeted. Subjects were stratified as to whether they were receiving psychoactive medications such as mood stabilizers, to ensure that about equal numbers of subjects were randomized based on this treatment profile.
755448|NCT00374231|From 3/2003 to 11/2005 forty adult deceased donor liver transplant recipients were enrolled. Subjects were eligible once they were greater than 90 days post liver transplant provided they had a 30 day rejection free period prior to enrollment.|
755449|NCT00374140||
755494|NCT00371566||
755495|NCT00371540||
755496|NCT00371462||
755497|NCT00371449||
755498|NCT00371436||
755450|NCT00374127|Normal, healthy volunteers ages 21-45 were recruited through newspaper advertisements and those who met inclusion/exclusion criteria after an initial phone screen were invited to the laboratory for further screening.|Prior to enrollment, participants gave written informed consent, received a psychiatric and medical evaluation, and provided a detailed drug use and medical history.
755451|NCT00374088||
755452|NCT00373958|Participants were recruited in the United States from September 2006 to January 2008.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
755453|NCT00373880||
755454|NCT00373698||
755455|NCT00373685||A total of 8140 participants were randomized into the trial, however the final analysis was on 8067 participants because 35 participants were randomized twice and 1 participant was randomized 3 times, totaling 73.
755456|NCT00373529||129 patients were screened and 116 participants enrolled/treated at 20 sites.
755457|NCT00373490|Phase I. First participant started on study therapy on 18-Jul-2006. Study was multicenter (total of 3 sites).|Study of 2 doses of vorinostat (MK-0683) in participants with solid tumors who failed standard therapy. >= 3 participants were enrolled at each dose. In the case of a dose level toxicity, a maximum of 6 participants were enrolled per level. If no safety problems, a total of 10 participants were evaluated for pharmacokinetics.
755458|NCT00373425|Patients with stage IB to IIIA epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC) were enrolled globally. 1252 patients were enrolled however 2 patients did not have adequate Health Insurance Portability and Accountability Act (HIPAA) documentation and were removed from the database.|Participants randomized prior to 7 November 2007 comprise the Breached-Protocol Cohort (BPC); those who had not discontinued were offered open-label erlotinib for up to 2 years. Participants randomized subsequently are referred to as the Randomized Cohort.
755459|NCT00373399|A total of 36 healthy research volunteers completed this three-session, within-subject outpatient study. Drug treatment was randomized.|
755460|NCT00373386||
755461|NCT00373360|Subject participated in this study between July 2007 and January 2008.|All subjects were required to be receiving continuous intravenous epoprostenol therapy for at least three months and at a stable dose for at least thirty days prior to enrollment in this study.
755462|NCT00373334||
755463|NCT00373295||13 participants were enrolled, but 10 participants were randomized. Three volunteers (1 female, 2 male) dropped out of the study during the marijuana abstinence phase (two were on baclofen and one was on placebo).
755464|NCT00373269||
755465|NCT00373256||
755466|NCT00373113||
755467|NCT00372996||
755468|NCT00372970|Patients all recruited at Temple University Hospital from 7/1/2005 to 9/1/2007|
755469|NCT00372957|This study was conducted across two centers in Japan from 22 March 2006 to 28 June 2006.|A total of 30 participants were randomized in the study. After screening, participants were washed off of diabetes medications for two weeks prior to the first dose of study medication.
755470|NCT00372905|The study opened for accrual on August 11, 2006 with an accrual goal of up to 24 patients. Accrual was suspended on September 9 2009 and reopened on November 30, 2009. The study was closed permanently on August 15, 2013 due to slow accrual with 18 patients enrolled and 17 patients treated on study.|
755471|NCT00372775||
755472|NCT00372697||
755473|NCT00372619||
755474|NCT00372593||
755475|NCT00372567||12 participants were enrolled in a lead-in Phase 1 safety sub-study, all of whom received Sunitinib 37.5 milligram (mg) 24 hours after the last dose of imatinib. No efficacy evaluations were planned/conducted for this sub-study.
755476|NCT00372528||
755477|NCT00372489||
755478|NCT00372424||
755479|NCT00372411|Between 11-8-06 and 10-31-08, 200 were screened and 127 randomized from 4 VA medical centers: Gainesville, West Haven, Baltimore, and Seattle. Usual care enrollment was stopped after 15 months when target information was attained per protocol. Recruitment to the robot-assisted and intensive comparison groups continued for 24 months.|
755480|NCT00372385||A total of 334 subjects were enrolled, of which 11 subjects discontinued the study prior to study drug administration. A total of 323 subjects started treatment.
755481|NCT00372255|This study was conducted by a principal investigator and 22 investigators in 18 centers in Germany.|
755482|NCT00372229||342 participants were screened, and 43 participants were not randomized. Central randomization stratified by study center and by induction immunosuppression with polyclonal antibodies, such as such as antithymocyte globuline (ATG), anti-lymphocyte globulin (ALG), or Muromonab-CD3 was performed.
755483|NCT00372190||
755484|NCT00372112|The study was planned on 80 male or female participants with moderate chronic obstructive pulmonary disease (COPD), aged 40 years or older from 03 November 2006 to 10 May 2007, across 14 centers of 6 countries (10 centers in Europe, 2 centers in Australia and 2 centers in New Zealand).|Out of 145 participants screened, 77 were screen failures and remaining 68 participants were randomized in the study to receive placebo, GW642444H (100 microgram [mcg] or 400 mcg once daily or Salmeterol 50 mcg twice daily (BD) via the DISKUS® dry powder inhaler (DPI).
755485|NCT00372060|"Phase III.
~Date of first patient in: 22 August 2006. Date of last patient's last visit for Period I: 1 May 2007.
~Date of last patient's last visit for Period II: 5 February 2008. Number of randomized patients: 134.
~The study was conducted at 32 centers in Japan."|"Following a screening period of at least 4 weeks and a 2 or 8-week observation period, patients who were on pioglitazone monotherapy for at least 8 weeks and met all other entry criteria were randomized to receive: sitagliptin/sitagliptin or placebo/sitagliptin.
~The starting dose of sitagliptin was 50 mg for all patients."
755486|NCT00371865||
755487|NCT00371839|Veterans from 50 to 75 years of age with hearing loss, not hearing aid wearers|"After audiometric thresholds were tested, subjects were assigned to one of three groups based on their pure tone averages (PTA) of thresholds at 500, 1000, 2000, and 4000 Hz. The groups were:
~Mild (PTAs of 20-39 decibels (dB) hearing level (HL) Moderate (PTAs of 40-49 dB HL) Moderate-Severe (PTAs over 50 dB HL)"
755488|NCT00371826||
755489|NCT00371787|Participants recruited from local communities in Kitchener-Waterloo, Canada between July 2006 and Feb 2007|38 participants recruited and screened; 4 withdrew by subject
755490|NCT00371761||
755500|NCT00371345||A total of 92 participants were enrolled in the study. Twenty-two participants did not enter the treatment phase, 13 because they did not meet entry criteria and 9 for other reasons. The 70 participants treated in the single-arm were stratified by tumor type into Her2-amplified and ER/PgR positive tumors.
755501|NCT00371293||
755502|NCT00371267||
755503|NCT00371254||55 participants were enrolled in the study; 11 discontinued prior to study drug administration (8 no longer met study criteria, 2 other reasons and 1 administrative reason by the sponsor)
755504|NCT00371176|The recruitment period was 2007 to 2011. Participants were recruited through VA clinician referrals and public advertising (e.g., flyers and radio ads).|
755505|NCT00371150|A total of 131 participants were enrolled at 27 sites.|Of the 131 participants enrolled, 85 were never treated (82 no longer met study criteria, 2 withdrew consent, and 1 had other reason).
755506|NCT00371137||
755507|NCT00370994|An interventional pain management practice, a specialty referral center, a private practice setting in the United States|
755508|NCT00370838||12 participants signed informed consent, but 2 participants were never randomized to treatment arm.
755509|NCT00370695||
755510|NCT00370682|A total of 120 subjects were enrolled in study|
755511|NCT00370552||Of the 136 participants enrolled in this study, 123 were randomized. Of the 13 not randomized, 11 no longer met study criteria, 1 withdrew, and 1 was found to have extensive disease. Of the 123 randomized, 122 were treated, and 1 no longer met study criteria and was never treated.
755512|NCT00370396|This study consisted of approximately 1200 subjects who were previously enrolled and had been vaccinated with either the 10Pn or 7Pn vaccine as part of the 10PN-PD-DIT-001 (105553) study (EudraCTnumber: 2005-003300-11).|During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected. Prior to vaccination, subjects' pre-vaccination body temperature was evaluated.
755513|NCT00370331||
755514|NCT00370292||Of the 19 enrolled patients, 12 were enrolled before the protocol amendment was made effective (i.e. 2-weekly administration) and 7 were enrolled after the amendment (i.e. 3-weekly administration).
755515|NCT00370149|Participants were recruited and consented during pre-operative visits at Riley Hospital between September 2006 and May 2010. Study catheters were assigned a random identification number by Cook Critical Care, Bloomington, IN. The clinical and infection control teams were blinded to which arm a patient was assigned.|Patients <18 years of age who had cardiovascular surgery with a case complexity warranting a central venous catheter received either an antibiotic impregnated catheter or a conventional non-impregnated catheter on a randomized, blinded 1:1 ratio.
755516|NCT00370071|The study was conducted in China between 08 November 2006 (first subject first visit) and 26 September 2008 (last subject last visit).|After a 3-month pre-treatment period with no MS-specific treatment, 39 subjects entered the 6-month treatment period. Of the 84 subjects screened, 40 subjects did not meet the inclusion/exclusion criteria, 3 subjects withdrew their consent, and 2 subjects died during pre-treatment.
755517|NCT00370032||
755518|NCT00369967||
755519|NCT00369941|"Primary therapy period: 14-Sep-2006 to 06-May-2009
~Multicenter (67) in the United States (18) and Ex-US (49)"|
755520|NCT00369928||
755521|NCT00369915||
755522|NCT00369824||
755523|NCT00369785|Patients were accrued between 2/2008 and 12/2011 at NCI CCOP sites across the nation.|
755524|NCT00369746|Participants were recruited from all participants entering the Sequenced Treatment Alternatives to Relieve Depression clinical trial.|
755525|NCT00369707|The study opened for accrual on August 8, 2006 with an accrual goal of up to 43 patients. The study was designed to enroll 15 patients initially to do an interim efficacy assessment. Accrual was suspended on November 14 2007 for this analysis and reopened on December 20, 2007. The study was closed on August 10, 2012 after 42 patients were enrolled.|
755526|NCT00369681||One subject withdrew consent prior to initiating the study.
755527|NCT00369668|Started August 2006 and ended June 2009|Inability to voluntarily execute 10 degrees of wrist/finger extension from a 60-65 degrees flexed position.
755528|NCT00369655|Twenty-one women were enrolled during the first stage of the study between January 2007 and March 2008.|
755529|NCT00369629|The study opened for accrual on June 6, 2006 in phase I with a 3+3 cohort design to find the recommended phase II dose. Phase II would expand to enroll a total of 20 evaluable patients at the recommended dose. The study was closed permanently on September 12, 2012 after 14 patients had been enrolled in the phase I part.|
755530|NCT00369590|Patients (pts) were enrolled from Feb 2007 - Nov 2008. pts were from seven different cancer centers and were recruited from their outpatient cancer centers.|
755531|NCT00369577|The study was conducted at 19 centers between Sep-2006 and Jan-2007. Patients recruited for screening were: 1) admitted to a hospital or research unit with acute agitation, 2) inpatients being treated for chronic underlying conditions who presented with acute agitation, and 3) patients with agitation treated in a psychiatric ED.|Pre-Treatment Period was defined as the period immediately prior to dosing in which screening procedures and inclusion/exclusion criteria were used to evaluate all patients for eligibility to participate in the study.
755532|NCT00369564||
755533|NCT00369512|Period of recruitment was December 2006 to June 2009. Patients were screened from radiation and head/neck clinics at UAB Hospital.|Single Arm study
755534|NCT00369486|Thirty-two clinical sites across the United States recruited 129 eyes of 109 subjects between December 2004 and September 2005. 113 subjects were randomized, but 4 were not included in any of the analysis because they were ineligible.|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
755535|NCT00369382|Actual number of participants randomized was 121; however 5 participants randomized in error. They were withdrawn from study as screen failures, not administered study drug. Participants randomized (121) lower than planned (200); more sites added, time period to enroll extended twice up to 2.5 years. Despite this, final enrollment below planned.|
755539|NCT00369265|Inadequate recruitment during this study; therefore, the study was terminated.|
755541|NCT00369161|Centers in 13 countries screened at least 1 patient: Argentina, Brazil, Chile, Czech Republic, France, Hungary, Mexico, The Netherlands, Poland, Portugal, South Africa, Spain,Turkey. Starting 27 June 2006 and ending 29 Dec 2008.|
755542|NCT00369122||
755543|NCT00368992||
755544|NCT00368979||
755545|NCT00368966|Participants were recruited in Spain from October 2006 to December 2006.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
755546|NCT00368940||
755547|NCT00368927|409 subjects were pre-registered through 6 Cancer Prevention Network (CPN) member organizations from 2006 to 2009.|346 subjects were excluded pre-assignment: 256 ineligible via sputum cytology/bronchoscopy, 37 patient/treating physician reasons, 12 comorbidities, 9 concomitant medications, 24 unable to adhere to the study timelines for tests/procedures, 8 other eligibility criteria. 2 subjects did not receive study intervention, were excluded from all analyses.
755548|NCT00368875|Between July 2006 and December 2009 a total of 54 patients were registered on the study.|
755549|NCT00368849|Participants (number = 20) were recruited using advertisements and through the University of Iowa Huntington Disease (HD) Registry at a rate of 1.40 individuals per month from September 2006 through November 2007 (i.e., 14.3 months).|Participants were screened before baseline for the presence of attentional problems through interview, medical status (including safety laboratories and electrocardiogram), and history for inclusion/exclusion criteria.
755550|NCT00368745||Prior to randomization, subjects were stabilized on a therapeutic dose of open-label alprazolam (minimum of 2 weeks) if they entered the study on a stable alprazolam dose or for up to 4 weeks if entered on a different benzodiazepine. Alprazolam dose range during 2-4 week stabilization phase was 1-4 milligrams (mg) by mouth (PO) twice a day (BID).
755551|NCT00368654||
755552|NCT00368641|12 sites were active to enroll subjects from March 2, 2007 through February 29, 2008|Subjects were required to meet all inclusion and no exclusion criteria for study participation
755553|NCT00368550|Recruitment from Feb. 2004 to March 2009 through advertisements and referrals by area clinicians.|All patients underwent physical examination and routine laboratory testing during screening. 143 prospective patients were screened, of which 4 did not meet study criteria and 5 chose not to participate.
755554|NCT00368537|Patients were recruited worldwide from September 2006 to August 2008.|Patients were screened according to the inclusion/exclusion criteria. Once informed consent was obtained, the patient was enrolled into the study and assigned a randomization number and a treatment regimen.
755555|NCT00368472||
755556|NCT00368459||
755557|NCT00368355||
755558|NCT00368316|Enrollment period: May 1, 2003 to January 31 3006. Surveillance period: May 1, 2003 to January 31 2008. Children were recruited from day care centers and health clinics in Israel|
755559|NCT00368290||
755560|NCT00368277||
755561|NCT00368251|72 subjects were screened, 56 subjects were randomized. Participant Flow refers to all subjects randomized who are identical with the Intent-To-Treat (ITT) Population, which consists of all randomized subjects who took at least one dose of study medication.|
755562|NCT00368108||
755563|NCT00368069|The N01235 study began recruitment in August 2006 with study completion occurring in May 2007.|Baseline and Participant Flow data consists of the Intent-to-Treat (ITT) analysis group. The ITT group consists of all randomized subjects.
755564|NCT00367991||
755565|NCT00367835||217 subjects were randomized (138 to SPD503 and 79 to placebo). However, only 214 subjects received at least one dose of study medication (136 for SPD503 and 78 for placebo). Therefore, 214 subjects constitute the safety population.
755566|NCT00367770|"Eight centers in six countries: Germany (1), Italy (2), the Netherlands (1), Spain (1), U.K. (2), U.S.A. (1)
~Patients with stable PAH upon completion of the BREATHE-5 randomized, double-blind, placebocontrolled 16-week study were given option to enter into the open-label extension study."|
755567|NCT00367744|Recruited at Case Western Reserve University and Cleveland Clinic. Recruitment occurred between from July 2006 (first subject was randomized) to December 2007 (last subject was randomized).|A total of 71 subjects were randomized. Results are reported for 71 subjects.
755568|NCT00367679||
755569|NCT00367640|First Patient First Visit 30 NOV 2004, Last Patient Last Visit 05 SEP 2005|
755570|NCT00367601||
755571|NCT00367484|Subjects were screened for enrollment from 27 May 2004 and attended the last visit on 30 January 2006. Four hundred and eighty four subjects were screened for enrollment and 460 were enrolled. Two subjects (0.4%) were excluded from the ITT Population since they had no post-Baseline NAb assessment due to withdrawing from the study prematurely.|"At Week -4 (to Week -1), subjects provided written informed consent and underwent screening procedures. Twenty four subjects were not included in the study: the reasons were Not met all eligibility criteria (18 subjects) and Other (6 subjects)"
755572|NCT00367458||
755573|NCT00367432|The Full Analysis Set (FAS) includes all subjects to whom the investigational products are assigned after registration, excluding those with serious Good Clinical Practice violations , subjects not administered the investigational products and subjects for whom no data is available after assignment of the investigational products.|"Eligible subjects from preceding study N01221 [NCT00280696] entered the First Period of this study and those subjects from N01221 [NCT00280696] who completed the First Period and subjects from the study N01020 [NCT00160615] entered the Second Period.
~Participant Flow and Baseline Characteristics refer to the FAS."
755574|NCT00367380||
755575|NCT00367341||
755576|NCT00367237|115 subjects (57 infliximab (IFX) + MTX and 58 MTX), but only 110 subjects (56 and 54) were considered intent to treat (ITT). Furthermore, 99 subjects (51 + 48) were in a treatment group at Week 16 for Primary Endpoint evaluation.|
755577|NCT00367133|Eighty-eight academic and community based sites across the United States recruited 693 subjects from May 2004 to July 2006.|
755578|NCT00367055||
755579|NCT00367003||37 participants were consented but only 28 participants underwent Subcallosal Cingulate Deep Brain Stimulation (DBS) between January 2007 and June 2013.
755580|NCT00366899|Participants were recruited in Italy from October 2006 to March 2007.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period. One subject was prerandomized and counted twice.
755581|NCT00366678|Participants were recruited in France from October 2006 to July 2007.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
755582|NCT00366626||
755583|NCT00366548|Participants were recruited in Poland from November 2006 to December 2006.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
755584|NCT00366535|Most patients were recruited by direct physician referral or through the Patient Recruitment and Public Liaison (PRPL) office. Potential subjects were screened for study eligibility at the NIH Clinical Center.|Patients with abnormal screening laboratory tests or had positive HIV test were excluded from study participation. Women who had positive urine pregnancy test were also excluded. Also patients with traumatic or non-traumatic pain disorders or had neurocognitive impairment making it challenging to obtain informed consent, were also excluded.
755585|NCT00366457||
755586|NCT00366444||
755587|NCT00366340|Participants were recruited in Germany from October 2006 to April 2007.|Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
755588|NCT00366301|Recruitment occurred at 73 US office-based practices between October 2006 and December 2008.|Preenrollment evaluation comprised local laboratory testing of hsCRP,HbA1c, and safety parameters (ALT or AST and creatinine). Eligible participants were enrolled in a 2-week run-in. Ability to self-monitor fingerstick blood glucose and perform insulin injection was determined and evaluation for evidence of marked hyperglycemia was undertaken.
755589|NCT00366275|Between January 2002 and September 2007, 64 patients with relapsed or refractory follicular lymphoma were enrolled in the trial|
755590|NCT00366249|Patients were recruited worldwide from January 2007 to February 2009.|Patients were screened for up to 24 hours.
755591|NCT00366106|15 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in July 2006 but was stopped in December 2008 at the point when it became clear that enrollment was too slow to complete the planned enrollment target of 45 patients within the time frame allowed.|Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
755592|NCT00366028||
755593|NCT00365989||Out of the 83 subjects signing consent, 33 subjects failed additional study requirements and did not participate. Fifty (50) subjects were treated; 48 received enhanced sonications, 2 received only nominal sonications.
755594|NCT00365976|Seventy adult volunteers with low back pain who met diagnostic criteria for insomnia were recruited through newspaper advertisements, posted announcements and physician referrals. Of those 70, 10 did not meet inclusion criteria, and 2 chose not to participate. The remaining 58 were randomized.|Qualifying subjects were switched from their current pain regimen to naproxen and lansoprazole. We excluded those with: significant medical or neurological illness other than LBP; psychiatric disease impacting sleep; substance abuse; history of hypersensitivity or contraindication to NAP/LAN or ESZ; abnormalities on baseline laboratory tests.
755595|NCT00365872|Patients with histologically confirmed large high grade soft-tissue sarcomas (STS) of the extremity/trunk/chest wall were enrolled to the study from 5/18/2006 to 2/19/2009. These patients had clinical stage T2N0M0 with a significant (>50%) risk of progressing to distant metastases.|
755596|NCT00365859||"109 participants were enrolled in the De Novo arm, 70 in the Rollover Placebo arm, and 174 in the Rollover Aripiprazole arm. 23 participants in the De Novo arm were considered baseline failures, and did not enter the treatment phase."
755597|NCT00365846||
755598|NCT00365794|Potential subjects were primarily recruited from 2011 to 2013 and were evaluated and studied at the University of Southern California CTSI Clinical Trials Unit. 22 subjects met all eligibility requirements and begun study therapy with testosterone gel. Two did not complete treatment. Thus, 20 completed all evaluations as planned.|"Consenting subjects were evaluated for eligibility and had to be:
~Men 60 years-or-older, with morning testosterone <400ng/dL, waist circumference ≥102cm, and evidence of insulin resistance; HgbA1c of 5.7-6.4% [20] or HOMA-IR ≥4.0. Exclusion criteria included diabetes, PSA ≥4.0μg/L, hct ≥50%, AST ≥2X ULN, concurrent inflammatory condition."
755599|NCT00365768|All subjects were consented according to Institutional Review Board approved guidelines during out routine outpatient or inpatient stay. The period of recruitment was from January 2007 to July 2011.|Fifty-six patients were enrolled and 49 were evaluable, with the reasons for removal from study after randomization due to: change in clinical status (N=3), family withdrew (N=2), family relocation (N=1) and other (N=1). 49 patients were randomized to the glutamine or placebo arm.
755600|NCT00365716||
755601|NCT00365599|Estrogen or progesterone receptor positive advanced breast cancer: Postmenopausal, failed first-line therapy with aromatase inhibitor or recurred within 12 months of adjuvant treatments with aromatase inhibitors; Premenopausal, recurred >12 months after adjuvant tamoxifen or never treated with tamoxifen; Not candidate for aromatase inhibitor|
755602|NCT00365547||46 patients were enrolled, only 43 patients received study medication
755603|NCT00365508|Participants were recruited through ads/physician referral at: FCCC, Geisinger Medical Center, Hematology Oncology Associates of Central NY, Howard University, LSU, Main Line Health System, Medical College of GA, Meharry Medical College, Mount Sinai Medical Center (Miami), North Shore University, SUNY Downstate Medical Center, and Virtua Health.|1299 individuals were screened for this trial over 4 years; 454 individuals were ineligible, 194 refused enrollment, and 651 were randomized. Nine individuals either withdrew from the study prior to treatment or were found to be ineligible after randomization and were removed from the intent-to-treat sample. The final ITT sample was 642 (321/arm).
755604|NCT00365456|"The trial was divided into 3 consecutive open-label treatment phases of 12 months with randomisation after Trial Period II.
~From 407 enrolled patients in total, 2 patients were enrolled but were never exposed to trial treatment. Thus, 405 patients in total received trial treatment."|"Period I: total number of 405 patients were included and all received PTH(1-84) treatment for 1 year
~Period II: of those 405 patients, 282 continued into the 2. year and all received risedronate
~Period III: during the 3. year, the remaining 268 patients were randomised to either PTH(1-84) (=136 patients) or risedronate (=132 patients)"
755605|NCT00365417||
755606|NCT00365391|Between October 2006 and March 2008, 27 patients with advanced hepatocellular carcinoma (HCC) were accrued onto the study.|
755607|NCT00365378||
755608|NCT00365365|239 participants were screened in this study. 214 were considered eligible for enrollment and 25 were screen failures. Of the 214 eligible participants, 155 were HER2-negative and 59 were HER2-positive.|
755609|NCT00365352||
755610|NCT00365300|Patients were recruited worldwide from September 2006 to August 2007.|Patients were screened for 2 weeks and provided non-pharmacologic conservative therapy including hypoallergenic formula thickened with rice cereal. Patients who improved on this treatment were not eligible for enrollment.
755611|NCT00365274|Recruitment Period: August 9, 2006 to February 26, 2009. All recruitment was done in medical clinics.|The six participants were registered at UT MD Anderson Cancer Center prior to early study termination although recruitment was open to multi-centers.
755612|NCT00365261||
755613|NCT00365209||This is a 2-stage study. In Stage1, there are 23 enrolled participants who received 2 g curcumin. In Stage2, there are addictional 21 enrolled participants who received 4 g curcumin.
755614|NCT00365144|Patients were recruited at a single U.S. clinical site between March 2006 and December 2008|
755615|NCT00365105||
755616|NCT00365053||
755617|NCT00364949|letters to participants from other studies and patients from Ob/Gyn at Northwestern|Exclusion based on personal/family history of diabetes or pre-existing medical condition
755618|NCT00364923|Patients were enrolled between 24 August 2006 and 14 April 2008 across 25 study sites, 15 sites in the United States (US), 8 in Europe, and 2 in Canada.|Patients (pts) were required to have at least 10 days of vitamin supplementation during the up to 12 days between enrollment & dosing. Four of the 115 pts enrolled were excluded during this period: 2 did not have an eligible PTCL subtype per central review, 1 had the presence of B-cell lymphoma per the investigator, 1 had progressive disease.
755619|NCT00364858|Eligible patients were randomized 2:1 to receive Cerezyme either once every 4 weeks (Q4) or once every 2 weeks (Q2) for 24 months. The studied period was from 14 December 2001 through 01 February 2007. There were 26 centers worldwide (18 United States, 1 Canada, 6 Europe, and 1 Brazil); 25 centers randomized patients to treatment.|
755620|NCT00364845|Participants were enrolled from 21 September 2006 through 6 November 2007|
755621|NCT00364832|A total of 137 participants were enrolled in this study conducted from 15 October 2001 to 7 July 2003 (core study period) and 19 September 2002 to 7 July 2005 (extension study period) at 22 centers (8 in Italy, 6 in the US, 4 in Germany, and 4 in Spain).|
755622|NCT00364819||
755623|NCT00364793|This study initiated February 2007 and completed July 2013. All participants enrolled in countries where efavirenz (EFV) oral solution was not commercially available could remain on study until their 7th birthday or until they were able to swallow EFV capsules (whichever occurred first).|56 participants were enrolled but 19 were never treated. Reasons for not treating: 2 deaths, 1 lost to follow up, 6 other (not specified), 9 no longer met study criteria, 1 withdrew consent.
755624|NCT00364689||The number of participants that were assigned to each Arm/Group is not known due to the data for this study no longer being available as the retention period has passed.
755625|NCT00364611||103 participants signed the informed consent for this study. Of these, 73 were determined to be eligible for inclusion. One participant did not receive any study treatment.
755626|NCT00364533||
755627|NCT00364377|Impaired Fasting Glucose (IFG) not on treatment with glucose-lowering medication|
755628|NCT00364351|First patient enrolled 24 August 2006, last patient enrolled 31 October 2007, cut off date 26 September 2008. 1574 patients were enrolled in the study.|1574 patients were enrolled/screened to the study but only 1240 patients were entered treatment/randomized.
755629|NCT00364286|Recruitment Period: 8/14/2006 through 11/28/2012. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.|
755630|NCT00364182||3 participants who enrolled in the study were not randomized to either prophylaxis treatment regimen, but participated in the study during the first on demand treatment period
755631|NCT00364156|Participants were recruited using mass media advertising from the the Greater Philadelphia area from June 2004 to April 2008.|Once participants were enrolled and were eligible at the medical screening visit they were randomized to receiving either 8 weeks of 21 mg nicotine patch or 6 months of 21 mg nicotine patch treatment
755632|NCT00364130|The recruitment period began May 17, 2007 and ended June 25, 2010. Participants were recruited from the Center for Inflammatory Bowel Disease at CHOP and through referrals from physicians outside CHOP. The study was also advertised on the Crohn's and Colitis Foundation Website.|Patients between the ages of 8-21 years with a diagnosis of Crohn disease for at least 6 months were eligible for a screening visit. Patients meeting the entry criteria (pQCT trabecular volumetric BMD z-score below the 25th percentile)were randomly allocated 1:1 to an active LMMS device or a placebo device.
755633|NCT00364013|"First patient enrolled 23 August 2006 and last patient enrolled 01 February 2008.
~Participant flow data are reported as of the data cut-off date of 28 August 2009."|
755634|NCT00363896|The study was conducted in 132 sites: 1 in Andorra, 5 in Austria, 4 in Belgium, 10 in Bulgaria, 8 in the Czech Republic, 3 in Denmark, 9 in France, 10 in Germany, 8 in Hungary, 6 in Italy, 4 in Netherlands, 9 in Poland, 9 in Romania, 25 in Russia, 8 in Spain, 13 in the UK. First patient was screened in Aug 2006 and last patient visit was May 2008.|"Following a screening visit, patients entered a 14-day run-in period during which they used inhaled salbutamol administered via a pressurised metered dose inhaler (pMDI) as rescue medication on an as needed basis. The 14-day run-in period was used to assess the stability of each patient's disease and baseline characteristics."
755635|NCT00363883||
755636|NCT00363805||
755637|NCT00363779||
755638|NCT00363766||
755639|NCT00363675||
755640|NCT00363649||Two participants were screen failures.
755641|NCT00363545||
755642|NCT00363480|Study was conducted at 27 centers in Germany from 17 May 2006 to 6 September 2007 on participants diagnosed with perennial bronchial asthma.|A total of 261 participants were screened, of which 40 were screen failure, remaining 221 participants entered the treatment period.
755643|NCT00363467|Recruitment period May 15, 2006 through May 20, 2009; H. Lee Moffitt Cancer Center.|The study did not involve a wash-out period or group assignment.
755644|NCT00363415||Participants who received at least one dose of study drug were, per protocol, the patient population used for the summary of safety data (eg, Serious Adverse Events).
755645|NCT00363311||A completed participant is defined as one who completed the 36-month treatment phase of the study and the 4-month safety follow-up phase.
755646|NCT00363298||
755647|NCT00363246|Recruitment began 06/01/2007; recruitment ended 11/30/2008. Data collection ended in December 2009. Subjects were approached in a VA medical clinic and given list of qualifying criteria on our flyer. After consent, a Mini-Mental State Examination (MMSE) is administered to all potential subjects; a score of at least 24 is required to participate.|
755648|NCT00363168||
755649|NCT00363142||Participants were stratified prior to randomization according to baseline regimen (700 milligrams [mg]/100 mg twice a day [BID] or 1400 mg/200 mg once a day [QD]) and previous regimen (no other prior protease inhibitor [PI], non-boosted PI, or boosted PI). Results are reported for the 209 participants (out of 211 enrolled) receiving study drug.
755650|NCT00363129|Two-hundred and seven (207) participants were recruited between December 2006 and December 2007 from 23 North Central Cancer Treatment Group (NCCTG) member sites.|There were a total of 11 cancellations (4 Vitamin E, 7 Placebo), 1 major violation on Placebo and 7 ineligible (3 Vitamin E and 4 Placebo) participants. Of these, 18 participants of cancellations/ineligible were excluded from all analysis.
755651|NCT00363077||
755652|NCT00363051||
755653|NCT00363038|Subjects were recruited at a university-based dermatology department in an urban center.|
755654|NCT00362882||
755655|NCT00362817||All patients had received prior systemic chemotherapy for the primary tumor
755656|NCT00362648|"The study was conducted at 5 international sites - Ghana, Kenya, Mali, Bangladesh, and Vietnam from 29 March 2007 (first patient in) to 13 October 2008 (last dose given).
~Last subject completed follow-up: 31 March 2009
~All data corrections applied (Frozen File): 20 July 2009"|Excluded from the trial before assignment to groups were subjects: with history of active gastrointestinal illness (vomiting, diarrhea, elevated temperature); who were participating in (or expected to participate in) other investigational-product studies; who could not be followed adequately for safety.
755657|NCT00362609|Patients were recruited in multiple countries worldwide from July 2006 to December 2007.|Patients were screened for up to 5 days.
755658|NCT00362466|A total of 156 subjects were to be enrolled; however, the attempts were unsuccessful and the study was closed after 3 subjects were enrolled. A fourth subject underwent screening, but was not randomized since the subject did not meet the inclusion criteria.|
755659|NCT00362453|During the 5-month recruitment period, we screened 366 patients from the Greater Boston area using telephone interviews. 62 potential patients visited the Clinical and Translational Research Center at Tufts Medical Center for further eligibility screening; 40 were eligible after baseline evaluation and randomized to Tai Chi or attention control.|We excluded individuals with: prior Tai Chi training or similar alternative medicine types like Qi Gong or yoga; serious medical conditions; intra-articular steroid injections in the last 3 months, reconstructive surgery on the affected knee, and intra-articular hyaluronate injections in the previous 6 months; failed the Mini-Mental examination.
755660|NCT00362440||
755661|NCT00362414|Subjects were consented and enrolled from September 2006 to February 2008 in accordance with local Institutional Review Boards at 3 North American sites: University of California Irvine Medical Center (n=11), Hoag Memorial Hospital Presbyterian (n=1), and the Foothills Hospital at University of Calgary (n=3).|
755662|NCT00362401|All 84 included patients were recruited from the same out patient clinic at the Heart Center, Bad Oeynhausen, Germany. They have been recruited between november 2005 and april 2006.|3 previously included patients were excluded from the analysis due to double mechanical heart valve prosthesis (in both mitral and aortic position).
755663|NCT00362375|Information about the study was disseminated through print media, public service announcements on local radio stations, electronic communication and informational mailings to local AIDS service organizations, county health departments, medical clinics, and community centers.|28 groups did not participate for logistical reasons, including lack of follow-up by group contact (10 groups), failure of women to arrive for the workshop (7 groups), and too few women to meet minimum workshop size (6 groups). Five groups did not participate because of insufficient interest by their members in receiving either workshop.
755664|NCT00362336|Participants were enrolled from 28 August 2006 to 11 February 2007 in 2 clinical centers in South Africa.|A total of 622 of the 715 recruited participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
755665|NCT00362297|Dates of recruitment: November 2006-August 2008 Site: University of Washington Virology Research Clinic, Seattle, WA|
755666|NCT00362232|The recruitment period was from 16 Jun 2006 to 31 Jan 2008.|3418 subjects were screened; 270 subjects were screening failures and were not randomized; 3148 subjects were randomized; 114 subjects did not receive medication; 3034 subjects received medication and were included in the safety population
755667|NCT00362180||
755668|NCT00362128||
755669|NCT00362115|Participants enrolled at 76 investigative sites in Argentina, Mexico, Peru and the United States from 16 May 2006 to 07 December 2006.|Participants with mild to moderate uncomplicated essential hypertension were enrolled in one of seven, once-daily (QD) treatment groups.
755670|NCT00361972|in clinics over 18 month period|washout after lansoprazole or placebo given
755671|NCT00361712|Women in labor were recruited for the study at entry to the triage area of the delivery room of a major tertiary medical center from January to May 2006.|
755672|NCT00361634|Participants were enrolled from 13 December 2006 through 27 April 2009|
755673|NCT00361595|Enrollment, 35 Subjects Start date: August, 2006 Completion date: April, 2008 Study took place at an academic medical center, recruiting subjects from investigator's practice.|
755674|NCT00361569||
755675|NCT00361504|The recruitment period for this out-patient, multicenter study occurred between 14 November 2006 & 25 July 2008.|In this study 1123 participants passed screening, 1121 participants were randomized (2 participants were not randomized in error) & 1117 participants received at least 1 dose of study medication (4 participants did not receive study medication)
755676|NCT00361439|Subjects were enrolled during relevant allergy seasons in Chicago, IL, from 2006 to 2008.|
755677|NCT00361374|196 adults with MDD were recruited from 05/18/06 to 06/30/11 at Massachusetts General Hospital and Cedars-Sinai Medical Center.|
755678|NCT00361335|The study was conducted at 86 investigational sites. The study population included 643 randomized participants from 15 countries.|A total of 643 participants were randomized in the IV Period (Main Study). A total of 508 participants were randomized in the SC Period (Extension Study); participation in the SC Period was optional.
755679|NCT00361296||2 participants were screen failures. 2 additional participants were removed from study by physician decision prior to receiving protocol intervention, so they never started the study.
755680|NCT00361283|University of Florida Clinical Research Center. Study started June 2004 and ended January 9, 2009.|
755681|NCT00361270||
755682|NCT00361257||
755683|NCT00361231||
755684|NCT00361218|Subjects were recruited from Boston/Salem Metropolitan Area via advertising on newspapers, television and radio, referrals from other clinicians, and patients who came into the Depression Research Program to participate in other studies|After consenting to participate, subjects were screened for the study and, if found to be eligible, returned for their baseline visit after one week, during which no psychotropic medication was allowed.
755685|NCT00361140|BMT population recruited from 08/01/2005 through 09/09/2012|candidates not meeting eligibility criteria excluded.
755686|NCT00360971||
755687|NCT00360828||A total of 12 consented, 2 were not eligible after the screening process.
755688|NCT00360724|Subjects were recruited by advertisements, website postings, and from the hospital's telephone referral service. Conducted between August 2006 and December 2011. Potential participants provided informed consent for study participation. A physical examination was performed and blood and urine samples were collected, including urine toxicology.|For patients on current ineffective psychotropic medication, washout was required, with >=7 days medication-free (>=28 days for fluoxetine). Concurrent sleep medication (zolpidem) was allowed for a maximum of 5 days during the study.
755689|NCT00360698||During Run-In period patients were not assigned to a treatment group. They were all treated with Insulin Glargine + Metformin + Glimepiride.
755690|NCT00360685||
755691|NCT00360672|Recruitment Period: 08/03/2006 through 05/10/2012. All participants recruited at UT MD Anderson Cancer Center.|
755692|NCT00360568||
755693|NCT00360555||
755694|NCT00360529||
755695|NCT00360490||807 subjects screened; 165 subjects randomized to either Levonorgestrel Intrauterine System (LNG IUS) or Medroxyprogesterone acetate (MPA) for treatment of idiopathic menorrhagia; 145 subjects completed study.
755696|NCT00360412||
755697|NCT00360399|Participants were recruited through the Emory University Mood and Anxiety Disorders Program. Men and women, aged 18-65, meeting DSM-IV criteria for a current major depressive disorder, and who had not received prior treatment for a mood disorder were eligible. 515 consented to participate in the trial and 344 were randomized to a treatment arm.|"A total of 344 participants were randomized as follows:
~114 randomized to the Escitalopram arm 115 randomized to the Duloxetine arm 115 randomized to the Cognitive behavioral therapy (CBT) arm
~28 participants did not return for a post-randomization assessment, resulting in 316 participants with data to analyze."
755698|NCT00360360||
755699|NCT00360334|This study was conducted at 35 study centers in the United Kingdom. Recruitment occurred from June 2006 to October 2007.|One patient assigned to the Insulin Glargine group withdrew from the study prior to receiving study drug. This patient is not included in the analysis set.
755700|NCT00360308||
755701|NCT00360282|Subjects were recruited from the general public in Pittsburgh, PA from October 2006 until November 2008.|36 subjects recruited; 9 were not assigned to a group (3 did not not meet migraine inclusion criteria, 1 was excluded on vestibular screening results, 1 withdrew, 4 were lost to follow up)
755702|NCT00360269|Participants recruited between November 2005 and June 2008 primarily through media advertisements and fliers|
755703|NCT00360243||
755704|NCT00360230||
755705|NCT00360126|A total of 11 participants were enrolled and randomized from 13 October 2005 to 12 February 2007.|Participants who had completed 32 weeks treatment period in study SCA101469 were enrolled in this extension study.
755706|NCT00360009||
755707|NCT00359983||
755708|NCT00359944||17 patients were excluded from analysis because of QA issues at a study site.
755709|NCT00359801|Subjects were recruited from primary care centers, diabetes and endocrinology clinics, and academic centers, and participated in the study between 22 July 2006 and 29 April 2009.|
755710|NCT00359788||
755711|NCT00359762||Patients meeting defined failure of HbA1c control (primary endpoint) in Study Period II were eligible for entry to Study Period III
755712|NCT00359736|2006-2009; U Miami and VA IPF clinics|Some were excluded after enrollment, because they did not meet entry criteria.
755713|NCT00359632|Nine centers (2 centers in Italy, 1 center in Sweden, and 6 centers in the US) enrolled subjects for inclusion in the study. Sites were selected based on their capability to perform the comprehensive testing and to treat types of infections that might require therapy with linezolid for 6 weeks or longer.|There were separate selection criteria for subjects in the treated and control groups. At the Screening/Baseline visit (Day 1), subjects were eligible for the study after verification that they met the relevant inclusion/exclusion criteria and the study had been explained to them.
755714|NCT00359619|The study is a safety follow-up of the primary study NCT00231413, starting from Month 18 post-vaccination.|A total number of 383 subjects were enrolled in the primary study. A total of 193, 216, 182 and 166 subjects attended Month 18, Month 24, Month 36 and Month 48 visits, respectively. No separate demography data was tabulated for these intermediate timepoints, as statistics were computed only after the last study visit at Month 48.
755715|NCT00359424|"A total of 656 participants underwent randomization
~participants to endovascular therapy >> and 222 to intravenous t-PA alone) at 58 study >> centers between August 25, 2006, and April 17, >> 2012 in the United States (41 sites), Canada (7), >> Australia (4), and Europe (6)"|
755716|NCT00359281|The study was performed from 19 May 2006 to 20 November 2007 at 1 medical clinic within the United States.|
755717|NCT00359216||There was a screening period followed by a 7-day run-in period, followed by the treatment period.
756115|NCT00330551||Of the 126 eligible and enrolled participants, 43 dropped out prior to the start of randomized treatment, resulting in 83 randomized.
755718|NCT00359203|From April 2007 to April 2011, 89 out of 511 patients (pts) implanted with implantable loop recorder (ILR) documented an asystolic syncope of >=3 sec or a non-syncopal asystole of >= 6 sec, inclusion criteria to be implanted with a dual chamber pacemaker (PM) and randomized to PM on or PM off. 77 pts out of 89 eligible pts were randomized.|12 out of 89 eligible pts refused randomization
755719|NCT00359138||
755720|NCT00359073||
755721|NCT00359021||Participants with human immunodeficiency virus - type 1 (HIV-1) infection were enrolled in this study from DUET Study TMC125-C206 or TMC125-C216 and met the definition of virologic failure at Week 24 or later in these studies, or who completed one of the DUET studies after 96 weeks of treatment.
755722|NCT00358956|From 29 August 2006 to 31 January 2008, 19 participants in 9 centers in 8 global countries received 100 mg vandetanib.|22 participants were screened; 19 participants received treatment.
755723|NCT00358917||
755724|NCT00358826|Patients had an Acute Coronary Syndrome (ACS) within 3 weeks prior to randomization|Subset of patients agreed to participate in a Multi-Detector Computed Tomography (MDCT) substudy for an additional 12 weeks of treatment for a total of 24 weeks
755725|NCT00358735|Multi-center study. Recruitment began June 2006 and ended September 2008|"Per protocol:. The pre-randomization evaluation (within 3 days of surgery, may be completed on admission) includes the following:
~Review of inclusion/exclusion criteria (including evaluation for clinical signs and symptoms of DVT or PE)
~Demographic parameters
~Medical history"
755726|NCT00358670||
755727|NCT00358644||
755728|NCT00358579|The recruitment period was from 9 March 2006 to 19 January 2009. Location of recruitment was in emergency departments.|The exclusion criteria included traumatic cardiac arrest or when cardiopulmonary resuscitation was contraindicated; for example those 'obviously dead' as defined by the presence of decomposition, rigor mortis or dependant lividity. Participants below the age of 16 years old were not included in the study
755729|NCT00358527||
755730|NCT00358501||
755731|NCT00358462|Men were recruited from a sexually transmitted diseases clinic in Seattle, Washington from January 2007 to July 2011|
755732|NCT00358449|Participants (par.) who met the eligibility criteria were randomized in to Treatment Cohort (TC) that consisted of a 2-week Screening Phase, a 12-week Treatment Phase, a 12-week Follow-up Phase and a 10-week Long term Follow-up Phase. Eligible par. who chose not to enter TC could be enrolled in an Observational Cohort to be followed for 24 weeks.|A total of 77 subjects participated in this study. Of this total, 59 par. were randomized into the TC to receive blinded study medication. An additional 18 subjects elected not to participate in the TC and were enrolled in the Observational Cohort. A total of 113 par. were screened for eligibility, of which 36 were screen failures.
755733|NCT00358436|This study was conducted in a total of 119 enrolling sites: 72 sites in the United States, 13 sites in Argentina, 13 sites in Australia, 7 sites in Canada, 2 sites in Mexico, 3 sites in New Zealand and 9 sites in South Africa. The first patient was screened in August 2006 and the last patient visit was in June 2008.|Following a screening visit, patients entered a 14-day run-in period during which they used inhaled salbutamol on an as needed basis. Patients also stopped taking any other COPD medications prohibited by the study protocol. The 14-day run-in period was used to assess the stability of disease and established the patient's baseline characteristics.
755734|NCT00358332|Parents in Bandiagara Mali were made aware of the study by a radio announcement and voluntarily brought their children to the Bandiagara Malaria Project (BMP) clinic on the campus of the Bandiagara District Hospital in Bandiagara, Mali. The first subject was enrolled on November 3, 2006 and the final subject was enrolled on December 12, 2006.|
755735|NCT00358215|First patient enrolled 13 June 2006; Last patient enrolled 4 May 2012|
755736|NCT00358150||A total of 50 participants were screened of which 24 participants were screen failure. A total of 26 participants were enrolled in this study.
755737|NCT00358007||
755738|NCT00357994||Studies S187.3.001 (NCT00357994) and S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. All study information and results presented reflect the study data and analyses for the two studies combined.
755739|NCT00357968||
755740|NCT00357955|Eligible patients were identified by a combination of the review of the VA Medical Center's electronic medical record system and referral by primary care providers. Recruitment started July 2004 and enrollment was completed by May 2007.|Once eligibility confirmed and consent signed, participants were randomized. There were no wash-out or run-in period.
755741|NCT00357903|Participants were enrolled from 31 July 1997 through 12 Oct 1999|
755742|NCT00357877||
755743|NCT00357760|The study was activated on 12/21/2007 and closed to accrual on 12/6/2013 with a total accrual of 94 patients.|
755744|NCT00357734|First subject enrolled: 16 June 2005, Last subject last visit: 18 May 2015. The study was conducted in Germany.|
755745|NCT00357656|Enrollment was conducted at 22 clinical sites in 12 countries (US, Austria, Norway, France, Portugal, Netherlands, Spain, Russia, Romania, Hungary, Italy, Poland). Of 85 participants enrolled, 72 participants participated in a PK study in the preoperative period; 63 participants were then randomized to treatment by continuous or bolus infusion.|Of 85 participants enrolled,15 were screen failures (2 after PK), 4 discontinued on the basis of the PK study in the preoperative period, 1 died, 1 was discontinued by physician decision (imprisonment), and 1 was discontinued per sponsor decision. Eventually, 63 participants were randomized to treatment by continuous (n=32) or bolus infusion (n=31)
755746|NCT00357552||
755747|NCT00357500|The study was open for patient accrual at 11 different pediatric oncology centers from January 7, 2005 through March 6, 2009.|Patients must have recovered or stabalized the toxicity from prior therapy.
755748|NCT00357396||
755749|NCT00357370|Of 163 participants enrolled, Of these 163 participants, 71 were randomized and received treatment. Of these 71 participants, 60 completed double-blind treatment period|
755750|NCT00357331||
755751|NCT00357214||
755752|NCT00357162|Twenty-one patients were accrued, and all were eligible and> evaluable.|
755753|NCT00357110||
755754|NCT00357097||
755755|NCT00357032||
756116|NCT00330460|First Subject Enrolled: 26-Apr-2006 Last Subject Enrolled: 17-Nov-2006|
755756|NCT00357006|Between 2006 and 2011, a total of 1858 women were assessed for eligibility, of which 204 were screened from inpatient and outpatient settings across three Australian sites (Alfred, a tertiary referral centre; Barwon, a rural centre; and Dandenong, an outer metropolitan centre) over a 5-year period and completed a 56-day trial.|
755757|NCT00356993||
755758|NCT00356915|Subjects were recruited from clinics in the US, Canada, South America, Ecuador, Dominican Republic, Panama, and Honduras.|Subjects were screened prior to randomization and had to have a positive result from a mycological culture of their toe nail (ie, culture that was positive for dermatophytes). If the culture was negative, they were not randomized to receive treatment and were discontinued from the study.
755759|NCT00356889|Fifty-six patients were enrolled between August 2006 and April 2008 at eight sites in the Phase II Consortium. The data are reported as of November 2009.|Three patients were ineligible after starting treatment (brain metastases, alteration in diagnosis, colitis). Two of these participants reported adverse events. Therefore, 56 participants were used for baseline, 53 patients were used for endpoint analyses, and 55 participants were used to report toxicity.
755760|NCT00356863|All cardiac patients hospitalized in 5 cardiothoracic clinics for coronary artery bypass grafting (CABG) surgery (with or without valve replacement) were offered to participate in the study based on inclusion criteria. Recruitment started on January 2004 and ended on November 2006.|All first 520 recruited participants from the 5 cardiothoracic units belonged to the control arm of the study and received usual care. The following 504 patients recruited in the 5 cardiothoracic units belonged to the intervention arm and received the educational intervention materials of the study regarding cardiac rehabilitation treatment.
755761|NCT00356811||
755762|NCT00356759||
755763|NCT00356603|This study was conducted from 20 June 2006 to 07 August 2006 across four centers in Japan.|A total of 75 participants with history of migraine or cluster headache persisting for at least 6 months had entered into the study.
755764|NCT00356590|Participants were enrolled from 3 March 1999 through 17 Mar 2000|
755765|NCT00356525||
755766|NCT00356434||
755767|NCT00356421|A total of 340 subjects were planned to be randomized; 87 were screened and 58 were randomized to study treatment prior to study termination.|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study.
755768|NCT00356408|The study was started in January 2007 with recruitment occurring in the United States, Germany, and Canada. The study had last patient last visit in February of 2010.|
755769|NCT00356369||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
755770|NCT00356304||
755771|NCT00356278|Participants were self-referred or referred by professionals. Some patients were referred from both VA personnel and non-VA sources between January 2007-May 2013.|
755772|NCT00356265|Three screen failures|
755773|NCT00356200||
755774|NCT00356187||Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention.
755775|NCT00356148|Patients were recruited at a tertiary university teaching hospital between October 2003 and March 2010.|Patients having male gender, diagnosis of Stage 0, locally advanced or bilateral breast cancer, receiving neoadjuvant treatment, planning to undergo reconstructive surgery, having immunodeficiency, receiving antibiotics during previous one month, undergoing breast / axilla operation before randomization, denying to provide consent were excluded.
755776|NCT00356135||30-330 days after acute coronary syndrome event, patients participated in 2 week open-label clopidogrel phase. Patients were then randomized to either 22-26 hour loading doses of: 60-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, then continued 2-week maintenance phase of 10-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, respectively.
755777|NCT00356122|The study was initiated in 18 sites in the United States, of which 14 sites enrolled a total of 85 participants.|"Of the 85 participants screened for this study, 32 were screen-failures. 53 participants were registered to receive treatment in this study, however, one participant did not receive any study medication.
~All 53 participants entered the follow-up period, even if they discontinued treatment."
755778|NCT00356057|A total of 153 patients were enrolled at 22 clinical sites from December 9, 2004 (the first implant of the study) through May 12, 2008.|No patients were excluded before assigment to groups. A total of 27 patients did not receive a device implant due to withdrawal of consent, inelegibility after randomization and unability to implant the LV lead.
755779|NCT00356031|Subjects were recruited from the multidisciplinary sarcoma clinic, surgical oncology, radiation oncology, and medical oncology clinics at the Massachusetts General Hospital, Brigham and Women's Hospital, or Dana-Farber Cancer Institute.|
755780|NCT00355914|The recruitment period lasted from November 2003 to July 2006.|
755781|NCT00355797||
755782|NCT00355784|All subjects were admitted to the Michigan Clinical Research Unit at the University of Michigan Hospital. Subjects were recruited from February 2006-February 2011.|Before the overeating intervention all subjects were admitted to the hospital for a 2-day experiment to assess their plasma growth hormone and insulin profiles.
755783|NCT00355706||
755784|NCT00355615|One-hundred male and female (Tanner stages II to V, at least 1 year post-menarche) children and adolescents (aged 10 to 17 years with Heterozygous familial hypercholesterolemia were randomized into the study, from 20 sites located in The United States (3 sites), The Netherlands (7 sites), Norway (1 site), Spain (3 sites), and Canada (6 sites).|Patients entered a 6 week dietary lead-in/drug washout period. Eligible patients were then randomly assigned to double-blind treatment with rosuvastatin 5 mg, 10 mg, 20 mg, or matching placebo, administered orally once daily for 12 weeks.
755785|NCT00355472|Participants were enrolled from 6 February 2007 through 22 October 2008|
755786|NCT00355394|Subjects recruited from tertiary care emergency department (ED). N=31.|
755787|NCT00355368||
755867|NCT00350532|Subjects were recruited from 9/1/2004-6/2/2006. Subjects were recruited from a pain clinic and the control group were healthy subjects.|No significant events or abnormal approaches noted.
756260|NCT00322231|"Patients were recruited at 9 sites in the United States.
~First patient enrolled: May-2006; Last patient last visit: July - 2007"|
755788|NCT00355342|Total 186 participants, with chronic obstructive pulmonary disease (COPD) were randomized at 31 centers in the United States. Study duration was 14-21 day Single-Blind Run-In period, 156-week treatment period and follow-up phone contact within 2 weeks of treatment stop.|A total of 247 participants were screened for this study, of whom 61 were screen failures and 186 participants were randomized in the study.
755789|NCT00355264|This study was a multicenter study, conducted at 8 sites in the United States of America and one site in Germany|A sample size planned of 10 to 15 subjects considered adequate based on clinical considerations. Actual enrolled and treated are 12 subjects.
755790|NCT00355199||
755791|NCT00355147||
755792|NCT00355134||Patients were randomized to receive fingolimod 0.5 mg, 1.25 mg or placebo for up to 24 months. Upon entry into the Extension phase, patients treated with fingolimod 0.5 mg or 1.25 mg during the Core phase continued treatment at the same dose, those previously treated with placebo were re-randomized in to receive one of the two doses of fingolimod.
755793|NCT00355121|Participants were enrolled from 16 October 2006 to 21 June 2007 in 45 medical centers in the US.|A total of 881 participants who met the inclusion and exclusion criteria were enrolled. Data on 879 that were vaccinated are presented in this reported.
755794|NCT00355082|All participants in the Treatment phase and all Baseline Failure participants are eligible to enter the Continuation phase. The Continuation phase is for long-term safety exposure to lamotrigine extended release (LTG XR) at 300 mg/day; it is not a cross-over phase.|The number of participants (par.) starting the Continuation phase (CP) does not equal the number completing the Treatment phase (TP), as 1) the CP was optional, 2) not everyone from the TP was eligible to enter the CP, and 3) par. who failed to qualify for the TP (Baseline Failures) were allowed to enter the CP. All par. start the TP at 300 mg/day.
755795|NCT00355056||60 day baseline diary completion prior to randomization.
755796|NCT00355030||
755797|NCT00354978|Recruitment Period: January 13, 2005 through January 31, 2007. All recruitment done at UT MD Anderson Cancer Center.|Forty nine (49) patients were enrolled onto the study, and 6 patients did not meet inclusion criteria and were excluded.
755798|NCT00354913||
755799|NCT00354887|Recruitment Period: November 1, 2004 and July 31, 2007. All participants recruited at UT MD Anderson Cancer Center.|Thirty-one patients were enrolled onto the study, and 30 patients received study treatment. One patient did not meet eligibility criteria and did not receive any study treatment. One additional patient was removed from the study after one treatment cycle.
755800|NCT00354835||481 excludes 33 ineligible cases (declared by the Study Chair) .
755801|NCT00354770||
755802|NCT00354744||
755803|NCT00354679||
755804|NCT00354640|Eleven women were enrolled from December 2006 to September 2008.|Women were required to be taking anastrozole as adjuvant treatment for breast cancer.
755805|NCT00354614||
755806|NCT00354601|Patients enrolled 01/23/2006 to 03/16/2007 at which time the protocol was suspended for lack of funding|
755807|NCT00354484|Hospitals and medical clinics|1 subject in each group were discontinued from the study prior to dosing due to subject request.
755808|NCT00354432||
755809|NCT00354341||
755810|NCT00354224||
755811|NCT00354172||
755812|NCT00354159|Recruitment began on April 28, 2006 and ended on January 14, 2011. All subjects were exited from the study on January 14, 2011. Fifty-three US clinical centers participated in the REDUCEhf study.|Enrolled subjects were required to have a successful implant of the Chronicle® device prior to randomization. 407 subjects had an attempted implant of the Chronicle® ICD (Implantable Cardioverter Defibrillator) (406) or Chronicle IHM (Implantable Hemodynamic Monitor) (1 subject). Of these 407 subjects, 400 were randomized.
755813|NCT00354107||
755814|NCT00354029||
755815|NCT00353977|"Hematopoietic stem cell transplant (sibling) donors and normal volunteers at a quaternary hospital.
~Recruitment: 3/05 to 11/06"|
755816|NCT00353873|The study was conducted at 46 sites in 12 countries: Belgium (4), Denmark (1), France (8), Italy (3), Latvia (3), Lithuania (3), the Netherlands (6), Norway (1), Poland (4), Russian Federation (9), Spain (3) and Sweden (1) from 18 November 2005 to 26 October 2006.|A total of 584 participants were screened and entered into a 4-week run-in period receiving fluticasone propionate (FP) 100 microgram (mcg) dry powder inhaler (DISKUS) twice-daily (BD) and inhaled salbutamol as required. The number of participants randomized was 321 and 303 participants received investigational product post randomization.
755817|NCT00353834|"Subjects were recruited from the Joslin Diabetes Center Clinic, Boston, MA, from July 2006-0ctober 2009. Subjects had Type 2 diabetes, treated with either Metformin, SU, Metformin/SU, TZD, or Metformin/TZD, on stable therapy and weight for 3 months.
~The healthy controls in the Extension Study, were recruited from the Joslin Diabetes Center."|Baseline fasting studies on all subjects included anthropometrics, blood pressure, HbA1c, glucose, insulin, c-peptide, lipids, free fatty acids (FFA), hsCRP, TNFa, IL-6, siCAM, sVCAM, PAI-1 antigen, and oxidized LDL. PWA and FMD were measured fasting and after a standardized meal with repeat PWA and FMD at 2 and 4 hours, and TNG at 4 hours.
755818|NCT00353795||
755819|NCT00353704|recruitment period november 2005 until june 2008|
755820|NCT00353652||119 subjects failed screening. 30 patients undergo 2-phase crossover study (chlorthalidone vs. spironolactone). 7 patients dropped out, 23 subjects completed study#1. 17 subjects undergo 3-phase study (chlorthalidone+placebo, chlorthalidone+spironolactone, and chlorthalidone+ irbesartan). 1 patients dropped out. 16 subjects completed study#2.
755821|NCT00353522||
755822|NCT00353496|264 subjects were screened at 48 investigational sites in 14 countries (Austria, Belgium, Czech Republic, Denmark, France, Germany, India, Italy, Poland, Slovakia, Spain, Sweden, United Kingdom and the United States of America). 204 subjects were randomised to receive study treatment in the Intent to treat (ITT) population.|
755823|NCT00353431|Recruitment Basel 22.01.2007 until 31.08.2008 Recruitment Solothurn 30.12.2006-29.04.2010|
755824|NCT00353418||
755825|NCT00353366||
755868|NCT00350519||37 participants were enrolled in the study. 18 participants were randomly assigned to the epoetin alfa group and 19 were randomly assigned to the Standard therapy group.
756295|NCT00320593|Between April 2005 and March 2007, 118 subjects age 8 to <12 years were enrolled in the study at 8 clinical centers.|
755826|NCT00353301|This was a phase II, single-arm, single-institution trial. A total of 25 patients were enrolled between July 2006 and March 2008 from University of Colorado Cancer Center.|Patients with previous treatment with erlotinib, gefitinib, sirolimus, temsirolimus or everolimus, untreated central nervous system metastasis, renal failure requiring dialysis or significant liver dysfunction were excluded from the trial.
755827|NCT00353275||
755828|NCT00353262|A total of 36 participants were enrolled in this study at three sites in Canada between 8 August 2005 and 24 April 2008.|
755829|NCT00353119||
755830|NCT00352911||
755831|NCT00352885|Participants were recruited from the Winship Cancer Institute in Atlanta, Georgia. Participant enrollment began in October 2006 and all study participation ended in May 2010.|Of 67 approached about the study, 26 met eligibility criteria and consented to participate in the trial. Two individuals did not come to the screening visit leaving 24 that were randomized evenly between the study arms. An additional 4 participants were discontinued prior to beginning IL-2 therapy, resulting in 20 participants who began the study.
755832|NCT00352846|Recruitment Period: 01/27/2006 to 08/13/2009. All recruitments done at UT MD Anderson Cancer Center.|Of 135 enrolled participants, 61 were excluded from the trial before assignment to groups due to screen failures.
755833|NCT00352794|Recruitment Period: July 2006 - April 2007|
755834|NCT00352781|Participants were recruited by their local public health unit.|
755835|NCT00352755||
755836|NCT00352690|Enrollment to the study was opened on 04/05/2006 and enrollment to the study closed 06/30/2008.|
755837|NCT00352664|Patient Recruitment: 12/10/03 for first patient through 09/14/05 for last patient. All participants recruited at UT MD Anderson Cancer Center.|27 patients were enrolled, 7 dropped out prior to assessment and were excluded from the overall study. Due to early termination, patients were not randomized.
755838|NCT00352612||
755839|NCT00352534||
755840|NCT00352417|Patients recruited from three Italian Medical Centers|
755841|NCT00352365||
755842|NCT00352118|Patients were recruited from the Masonic Cancer Center physicians' clinics.|
755843|NCT00352105|Patients accrued between April 2003 and December 2007 from clinical facility|
755844|NCT00352053|There were 17 sites in Brazil and 1 site in Panama. First participant was screened on 13 June 2006. The last study visit occurred on 19 December 2013.|123 participants were screened.
755845|NCT00352027|Participants were enrolled between July 2006 and March 2012.|One participant was determined to be ineligible after enrollment and prior to start of therapy.
755846|NCT00352001||
755847|NCT00351936|Potential subjects will be identified by their clinicians at the Freedom Trail Clinic. Targeted enrollment will include 20 stable outpatients with schizophrenia or schizoaffective disorder treated with olanzapine for at least one year. Patients will be excluded for significant medical illness, and substance abuse.|Sixteen subjects consented to participate. One subject was found ineligible for the study due to recent changes in medications and did not reach baseline/group assignment. Available data from the remaining 15 subjects are included in all analyses.
755848|NCT00351819||
755849|NCT00351741|After 3 yrs of enrollment, interim analysis revealed a significant number of subjects in the LTV arm required rescue, which served as the trigger to close the study to further enrollment. Between April 2006 and May 2009, 387 patients were screened for eligibility. 155 patients met criteria of which 62 were randomized, 31 in each arm.|
755850|NCT00351533||
755851|NCT00351468|Subjects were previously enrolled in a study of eltrombopag: TRA100773A, TRA100773B, TRA102537/RAISE, or TRA108057/REPEAT. Eligibility of consenting subjects was assessed during the screening period of up to 28 days prior to Day 1 of treatment.|
755852|NCT00351416||Four subjects did not meet inclusion criteria (2 had increased prolactin, 2 had abnormal cycles) and were excluded after screening and before assignment to treatment.
755853|NCT00351377||
755854|NCT00351351|Patients undergoing percutaneous nephrolithotomy with a target stone size greater than 2cm|
755855|NCT00351299|Patients admitted to ICU from 2005-2008|Patients enrolled and randomized upon admission to ICU but treated with dexmedetomidine or standard of caremodalities only if they developed delirium.
755856|NCT00351273||
755857|NCT00351039|July 2006 through September 2008 at Moffitt Cancer Center|Phase I run-in. One participant was excluded due to screen failure, showing that they should not have been included to start.
755858|NCT00351000|Subjects will include 40 outpatients with schizophrenia or schizoaffective disorder treated with clozapine or olanzapine for at least one year. Twenty clozapine-treated subjects and twenty olanzapine-treated subjects with type 2 diabetes mellitus, impaired fasting glucose or insulin resistance will be recruited.|24 subjects consented for the study. Two subjects consented but were lost to follow-up, and one subject withdrew consent after receiving one dose of ziprasidone.
755859|NCT00350870||181 patients were assessed for eligibility. 40 were found to be ineligible, and 42 did not complete the screening. 99 were randomized, but only 80 started (defined as having at least 1 day of study medication).
755860|NCT00350844|This study is currently closed to patient accrual at all sites due to poor enrollment, including Children's Memorial Hospital, Washington University, Johns Hopkins and the Medical College of Wisconsin. The FDA was notified in 2010, and the IND was removed for this study.|
755861|NCT00350792||
755862|NCT00350779|"Phase III
~First Patient In: 29-Aug-06. Last Patient Enrolled: 23-Mar-07. Last Patient Last Visit: 27-May-08; 41 study centers worldwide"|Patients 18-78 years of age with T2DM and inadequate glycemic control (HbA1c ≥7.5 and ≤11.0%) who were on stable doses of rosiglitazone (≥4 mg/day) and metformin (≥1500 mg/day) after an up to 20-week dose-titration and stabilization period were eligible to enter the 54-week study.
755863|NCT00350727|Phase I and Phase II had two separate participant populations. Enrollment in Phase II was not dependent on the number of participants completing Phase I.|
755864|NCT00350636||
755865|NCT00350623|Phase IIa; First Patient In: 24-Oct-2006; Last Patient Last Visit 30-May-2008. 21 sites, all in the United States of America.|All patients had to demonstrate good health, be at low risk of acquiring HIV infection, and met a number of laboratory criteria. They could not have previously received an investigational HIV vaccine, had a contraindication to intramuscular injection, or weighed less than 105 pounds.
755866|NCT00350545||
755869|NCT00350402|Parkinson participants were recruited from the University of Florida Center for Movement Disorders and Neurorestoration. Recruitment began in 2004 and ended in 2009.|"Several participants were enrolled, but subsequently excluded (prior to randomization) when it was learned that they had medical conditions that had not initially been divulged or detected (i.e., seizure disorder, booster ECT for treatment of depression)."
755870|NCT00350363||
755871|NCT00350337||
755872|NCT00350272|HIV-1-infected, treatment-naïve adults with no AIDS-defining events in the 3 months prior to Screening and with plasma HIV-1 RNA levels greater than or equal to 5000 copies/mL and CD4 counts greater than or equal to 200 cells/μL and less than 500 cells/μL and HIV-1 strains absent the M184V, M184I, D237E, K103, Y188L, and K65R mutations at Screen.|A total of 78 were given a treatment assignment. One subject assigned to treatment was ineligible for randomization and did not receive any study drug. An additional subject did not take any of the dispensed study drug. Therefore 76 subjects were treated.
755873|NCT00350220||
755874|NCT00350207||
755875|NCT00350142||
755876|NCT00350025||
755877|NCT00349973||Four participants were excluded prior to randomization (1:positive urine tox screen; 1:participant uncooperative with clinical interview; 1:withdrew consent; 1:history of cardiovascular disease).
755878|NCT00349921|24 Subjects with chronic pain were recruited from the Center for Clinical Research. Each subject was scheduled for a study visit and randomized to receive spinal clonidine, spinal adenosine or placebo. The subject was scheduled for a second study visit and received the opposite treatment from the first visit.|24 subjects consented and enrolled 2 subjects withdrawn prior to group assignment because they did not meet inclusion / exclusion criteria on second review
755879|NCT00349908|Patients were recruited at 1 hospital in Argentina in 2006 and 2007 and treated with Codman Neurovascular Self-Expanding Stent System.|This is a device study, there was no wash out or run-in phase for transition.
755880|NCT00349778||
755881|NCT00349752|A Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Subjects With Moderate to Severe Crohn's Disease from November 2006 to July 2009|
755882|NCT00349713|175 participants were screened; 115 were excluded; 60 subjects were randomized in a 2:1 ratio into 2 cohorts|
755883|NCT00349622|Ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. Subjects with ALS were enrolled in 58 institutions across in the US and Canada.|Participants were randomly assigned to receive treatment with ceftriaxone or placebo for at least 12 months. Two thirds of participants received ceftriaxone and one third received placebo. This is a blinded study, so neither participants nor study staff knew which treatment a participant is receiving.
755884|NCT00349466||
755885|NCT00349388||
755886|NCT00349349||
755887|NCT00349336|A total of 64 patients in 7 centers were enrolled between 01 August 2006 to 28 May 2008. 37 were included in the pharmacokinetic (PK) analyses.|
755888|NCT00348933||
755889|NCT00348881|Participants were enrolled and treated from 17 May 2006 to 26 September 2006 in 1 clinic center in the Philippines.|A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
755890|NCT00348816|Enrollment opened on 21 Mar 2006 and closed on 15 Apr 2009. The first subject was consented on 18 May 2007 and the final subject on 14 Apr 2009. Subjects were all enrolled in outpatient clinics and received treatment as outpatients.|Subjects must have histologic diagnosis of prostate cancer and be post prostatectomy. They must have a PSA > 0.2 ng/ml (verified on 2 separate tests, at least 2 weeks apart). CT abdomen/pelvis and bone scan must be negative. One subject was a screen failure due to CT showed lung mass (not related to prostate cancer).
755891|NCT00348790||
755892|NCT00348686|Milestone date: 15 June 2006 (FSI) ~ 05 June 2008 (LSLV) Type of location: General Hospital; 333 subjects enrolled, but 18 subjects failed to be randomized, 315 subjects were randomized to study.|Screening period: Laboratory test (Creatinine, potassium, ALT, etc)
755893|NCT00348673||
755894|NCT00348595||17 subjects were screen failures
755895|NCT00348556|Subjects were recruited from the Mayo Clinic in Rochester, MN.|
755896|NCT00348374|Participants were recruited from 62 centers between June 2006 and August 2008.|
755897|NCT00348348|This study was conducted at 84 sites in the US and Asia. First subject was enrolled 6/6/06, and last subject visit was 7/13/07.|1161 participants were randomized of which 533 had culture confirmed bacterial conjunctivitis.
755898|NCT00348309|The study was conducted on participants with mild to moderate Alzheimer's disease(AD), who received donepezil for at least 6 months and who received a stable dose of donepezil for at least 2 months immediately before study entry from 06 July 2006 to 28 January 2009 across 228 centers of 19 countries.|A total of 1496 participants were randomized for the study, out of which seventeen participants did not receive study medication. A total of 1479 were included in the Safety population.
755899|NCT00348283|Subjects were to be enrolled in 9 countries. Subjects were enrolled at 19 sites in 8 countries. No subjects were enrolled in Sweden.|All subjects (135 subjects) enrolled in the study received an open-label dose of 160 mg adalimumab subcutaneously (SC) at Baseline (Week 0) followed by 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC every other week (eow) or placebo SC eow(129 subjects).
755900|NCT00348205||
755901|NCT00348140|A total of 1485 participants with Alzheimer's disease (AD) who were being treated with an approved Acetylcholinesterase inhibitor (AChEI) were randomized in the study and stratified by Apolipoprotein E gene (APOE) ε4 allele status. Total of 1468 were included in safety population and 1429 in the intent-to-treat population (ITT).|
755902|NCT00347958|Participants were enrolled from 21 August 2006, to 12 April 2007, in 6 clinical centers in the US and 6 clinical centers in Canada.|A total of 545 participants were enrolled and vaccinated in the study. Data on 544 participants that met the inclusion and exclusion criteria were analyzed and reported. One participant who did not receive Adacel® vaccine in one of the previous studies was excluded from the Safety Analysis Set.
755903|NCT00347932|First subject enrolled 6/5/2006, last patient exited on 11/7/2007. This study was conducted at multiple sites in the US.|957 Subjects with bacterial conjunctivitis were randomized to receive besifloxacin ophthalmic suspension or its vehicle, 11 subjects were discontinued due to failure to meet enrollment criteria or used disallowed medications.
755904|NCT00347919|Participants (par.) were enrolled into two cohorts. Cohort 1: Par. were randomized 1:1 to lapatinib 1500 mg or lapatinib 1000 mg/pazopanib 400 mg. Cohort 2: After enrollment was complete for Cohort 1, par. were enrolled to lapatinib 1500 mg/pazopanib 800 mg. All par. who received study drug are accounted for in the Participant Flow module.|Female par. with >=18 years of age with histologically confirmed invasive breast cancer were enrolled in the study. Total 189 par. (Cohort 1, combination n = 76, lapatinib n = 73; Cohort 2, n = 40) received study drug.
755905|NCT00347776|Patients were randomly assigned initially to receive single dose of oral azithromycin to subject or single dose of azithromycin to subject & immediate family members or topical tetracycline ointment to subject groups.1 yr data suggested no difference in outcome between 2 azithromycin arms.These 2 groups were combined into 1 group in final analysis.|
755906|NCT00347438||
755907|NCT00347360||
755908|NCT00347308||
755909|NCT00347269||
755910|NCT00347022|First patient first visit = 30/05/2006 Last patient last visit = 14/04/2009 Location = radiological department (Hospitals)|Any patient having a creatinine clearance < 60ml/min/1.73m² at time of baseline blood sample and/or positive beta HCG (Human Chorionic Gonadotropin) within 48h before contrast medium administration was considered as immediate withdrawal from trial
755911|NCT00347009||
755912|NCT00346905|Referral patients experiencing moderate to severe GERD|Those not meeting inclusion/exclustion criteria were not included
755913|NCT00346775|The study was planned on 90 participants, male or female aged 18 years or older, diagnosed with seasonal allergic rhinitis (SAR) across 8 investigational sites in the United States (US) from 01 May 2006 to 29 June 2006.|A total of 97 participants were randomized for the study in a crossover manner in a ratio of 1:1 to one of two blinded treatment groups of 116 microgram (µg) Nasarel or 168 µg Beconase AQ® metered dose nasal spray to be administered twice daily for 1 week. The study consisted of 2 treatment periods of 1 week each and 1 washout period of 7 days.
755914|NCT00346697|Recruitment took plave between November 2006 and September 2010 at 3 sites (Johns Hopkins University, Baltimore, MD;Veteran's Administration Greater Los Angeles Healthcare System (Los Angeles, CA), and the Georgetown University Hospital (Washington, DC). Participants were recruited from the HIV Clinics at these institutions.|
755915|NCT00346632|Four study centers in the US|
755916|NCT00346476||
755917|NCT00346398|Subject recruitment occurred between June 2006 and July 2007 at 2 sites in Australia and 1 site in the United States|At a screening visit, subjects underwent procedures to establish that all inclusion criteria were met and none of the exclusion criteria were met. All guardians provided written informed consent
755918|NCT00346333|We performed screening examinations in the Berman-Gund Laboratory at the Massachusetts Eye & Ear Infirmary, Boston Massachusetts from July 15, 2003 to October 28, 2004.|We screened patients for eligibility according to ocular, dietary, and medical criteria & performed a baseline examination on eligible patients within 8 weeks. At the baseline visit patients were randomized to 1 of 2 groups taking into account genetic type and initial serum lutein level (<= 6.4 micrograms/deciliter (mg/dL) or > 6.4 mg/dL).
755919|NCT00346268|This study was terminated prematurely due to slow recruitment.|
755920|NCT00346216|The study was conducted at 950 centers in Australia (11), Brazil (30), Canada (64), Colombia (7), Costa Rica (12), Hong Kong (4), Mexico (11), Panama (2), Peru (5), Philippines (8), Taiwan (10), Ukraine 19), and United States (767); a total of 24 sites were activated but did not randomized any subject.|All eligible participants were enrolled in to the study.
755921|NCT00346164||
755922|NCT00346151|Two centers in the United States enrolled five recipients of non-human leukocyte antigen (HLA)-identical living-donor-related renal transplants between January 2007 and January 2009.|At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and sign the informed consent form.
755923|NCT00346073||A total of 2337 subjects were enrolled into the study. Of these, 53 subjects were allocated subject numbers, but did not receive study vaccination.
755924|NCT00346034|The study was planned to include all eligible subjects continuing from the preceding double-blind study A0081100 NCT00333866 (Subjects had to be at least 18 years old and have met the American College of Rheumatology criteria for fibromyalgia).|Following the termination visit in study A0081100, subjects had an option of starting pregabalin under open-label conditions the day after the termination visit.
755925|NCT00345969|Participants were recruited from orthopedic units of local hospitals, rehabilitation facilities (both acute rehabilitation units and SNFs), home care programs, and the community-at-large.|Participants were carefully screened for exclusion criteria prior to randomization.
755926|NCT00345878||
755927|NCT00345865||
755928|NCT00345839|Participants were recruited from dialysis clinics and hospitals between August 2006 to Jan 2008 from 22 countries.|Participants were screened over a 30 day period.
755929|NCT00345683|This summary presents results for the booster/fourth dose vaccination phase up to the end of the 6-month safety follow-up. Subjects received 3-vaccine doses in the study NCT00345579 and were followed up to, but excluding, the fourth dose vaccination. This study begins 10 months after the first vaccination in the primary phase.|Of the 4021 subjects enrolled, 4020 received a booster vaccination and 3986 completed the booster phase (2985 in the Menhibrix Group and 1001 in the ActHIB Group)
755930|NCT00345631||
755931|NCT00345605|12 subjects with argininosuccinic aciduria were recruited at Baylor College of Medicine from May 2008 to December 2010.|patients were randomly assigned to one of the two arms HDA or LDA after treatment and an interval the same patients returned and received the crossover treatment LD or HDA depending.
755932|NCT00345592|First patient was enrolled on the 3rd of October, 2006. Last patient was enrolled on the 29th of July 2009, for a total of 420 patients.|"24 subjects were not randomized:
~7 died before randomization (causes: 3 cardiac, 2 non-cardiac, 2 unknown);
~7 voluntarily withdrew;
~5 withdrawn due to AF.
~2 had device explanted before randomization;
~1 had biventricular pacing turned OFF
~1 was withdrawn from the study for inclusion criteria violation;
~1 lost to follow up."
755933|NCT00345579|This summary presents results for the primary vaccination phase up to the end of the extended safety follow-up (until, but excluding, the booster dose at 12-15 months of age). For results about the booster/fourth dose phase, see study NCT00345683.|Of the 4432 subjects enrolled, 4391 were vaccinated and 4162 completed the primary vaccination phase of the study (3114 in the MenHibrix Group and 1048 in the ActHIB Group).
755934|NCT00345540|The trials opened to enrollment July 2006 and the study was closed out June 2008. Recruitment locations were: Dana Farber Cancer/Partners Cancer Care, Boston, MA and Massachusetts General Hospital, Boston, MA|Patients were platinum refractory/resistant, with measurable disease and ≤ 3 prior lines.
755935|NCT00345397||
755936|NCT00345384|Participants will be recruited from the from the BUMC Operating Room schedule prior to their procedure. Informed consent will be obtained in a secure area. Recruitment will continue until goal reached.|Participants were required to be between the ages of 18-85 and receiving general anesthesia with an AMerican Society of Anesthesiologists score of three or less, and undergoing thoracotomy surgery. Liver and renal failure patients were excluded.
755937|NCT00345371||
755938|NCT00345358|The study included a primary (PRI) phase (all groups) and a booster (BST) phase (only 10Pn <6M and Synflorix 7-11M Groups).|At screening the following was performed: informed consent was obtained from & signed by subjects' parents/guardians, check for inclusion/exclusion criteria and precautions was performed as regards contraindications to vaccination, and medical history of subjects was collected. Subjects' pre-vaccination body temperature was evaluated.
755939|NCT00345345||
755940|NCT00345332||
755941|NCT00345293||
755942|NCT00345254||
755943|NCT00345176|Between October 2006 and September 2008 a total of 4,203 participants aged 50 - 85 years were randomized at 82 clinical sites.|Prior to randomization, participants had to complete the Qualification phase. They could only be randomized if they took at least 75% of the run-in medication.
755944|NCT00345046|Recruitment period Feb 2005 - Jun 2008 Subjects were recruited from surgical schedule.|One subject was disqualified due to previous laser treatment. One subject did not receive study medication therefore was discontinued from study participation.
755945|NCT00345033|Subjects were recruited from the Freedom Trail Clinic at the Erich Lindemann Mental Health Center and were studied at the General Clinical Research Center (GCRC) at the Massachusetts General Hospital (MGH), Boston and the Freedom Trail Clinic.|After providing written informed consent, subjects underwent a diagnostic evaluation by a research psychiatrist using the Structured Clinical Interview for DSM-IV (SCID). All subjects were screened and enrolled based on eligibility criteria. Baseline study assessments were completed prior to intervention.
755946|NCT00344968||
755947|NCT00344773|147 patients were screened for epidermal growth factor receptor (EGFR) mutation and 46 patients were enrolled in this study. Subjects were recruited by 7 investigational centers throughout South Korea from Mar 2006 to May 2007|
755948|NCT00344682|Study participants were recruited through clinician referral and posted and radio advertising with the majority of patients recruited through clinician referral within our single-site, tertiary-care medical center.|Participants continued on their previously prescribed antidepressant at the same dose throughout the study.
755949|NCT00344500|225 volunteers were screened November 2005 to August 2008 from Veterans Hospital psychiatric clinics in West Los Angeles, USA.|122 volunteers met the inclusion criteria, signed the informed consent document, and completed the baseline screening assessments prior to randomization to study groups.
755950|NCT00344487|This study received IRb approval on 12/7/05. Recruitment was difficult and the inclusion criteria was amended in November 2007 to help increase enrollment.|
755951|NCT00344461||
755952|NCT00344448||
755953|NCT00344370||
755954|NCT00344318||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
755955|NCT00344305|A total of 200 participants were enrolled in the study from 15-May-2006 through 22-Jun-2006 at 16 sites in the United States of America.|A total of 200 participants were stratified on the basis of their age into two cohorts: Cohort 1 (participants aged between 6 to less than [<] 24 months) and Cohort 2 (participants aged between 24 to < 60 months).
755956|NCT00344175|Patients with primary hypercholesterolemia or combined dyslipidemia, who have satisfied the inclusion/exclusion criteria of the core study, and completed the core study were eligible for this study.|
755957|NCT00344032||
755958|NCT00344019|Patients presenting to cath lab for angiogram with unstable angina were approached for participation. If patients agreed to participate, blood was drawn for laboratory evaluation of cardiac enzymes. If enzymes elevated, patient unable to continue participation. Patients proceeded to angiogram as planned. If no PCI performed, patient excluded.|97 patients were consented to participate but 74 of them were screen failed afterward due to not meeting angiographic, laboratory or other inclusion criteria. Hence, patients who were screened, but did not complete the study, were not considered enrolled
755959|NCT00343915|All subjects who participated in the primary vaccination study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up were contacted by the investigators. No additional subjects were recruited during this long-term follow-up study.|
755960|NCT00343889|Participants were enrolled and treated from 07 July 2006 to 26 September 2006 in 2 clinical centers in the Philippines.|A total of 379 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
755961|NCT00343863||
755962|NCT00343785||
755963|NCT00343564||
755964|NCT00343512|This study enrolled patients from February 2004 to September 2007.|A total of 39 people were consented, one of which was ineligible. Four patients withdrew from the study before beginning treatment.
755965|NCT00343460||
755966|NCT00343382|Two-hundred and one (201) participants were recruited between December 2006 and May 2009 from 22 North Central Cancer Treatment Group (NCCTG) member sites.|Five participants (2 collective placebo, 2 Pilocarpine 2 times per day, 1 Pilocarpine 4 times per day) canceled prior to study medication begins and one Pilocarpine 2 times per day participant was ineligible. These six participants were excluded from all analysis.
755967|NCT00343291||
755968|NCT00343252||712 participants were randomized: 361 to teriparatide; 351 to risedronate. 2 participants did not receive drug. Only randomized participants who received at least 1 dose of drug were analyzed. At 18 months, reason for discontinuation was corrected from sponsor decision to entry criteria not met (1) and protocol violation (1) for 2 participants.
755969|NCT00343083||
755970|NCT00343044|Subjects enrolled from August 2006 to November 2008, in the medical oncoogy practices at Virginia Mason Medical Center and the Puget Sound Oncology Consortium in Seattle, WA.|Women had advanced or recurrent epithelial ovarian, peritoneal, or fallopian tube cancer. Enrollment was restricted to women who had received a maximum of two prior chemotherapy regimens, with at least one prior primary taxane and platinum-based therapy.
755971|NCT00342628|Informed consent was obtained from expectant women during prenatal visits in Thanh Thuy District, Phu-Tho Province, Vietnam. Mothers and newborns were enrolled during labor at commune/district health centers from July 26, 2006 to March 8, 2007. Only fullterm newborns with birth weights of >=2500 grams were enrolled.|
755972|NCT00342563||
755973|NCT00342355||
755974|NCT00340834|Patients randomized in the Core Phase (CP) to receive 0.5 mg or 1.25 mg fingolimod received the same dose in the Extension Phase (EP). Patients randomized to receive interferon-β-1a in the CP were re-randomized to receive either 0.5 mg or 1.25 mg fingolimod in a 1:1 ratio in the EP. Upon protocol amendment, all patients received 0.5 mg fingolimod.|
755975|NCT00340704|This trial has 3 different Data base locks (DBLs) based on 3 separate populations PK/PD, Group D-Denovo & Group D-527.51 Rollover. For population PK/PD the DBL date was 18July2007, Group D-Denovo the DBL date was 23Jan2009 & Group D-527.51 Rollover the DBL date was 11Sep2009.|Three different Clinical trial reports were prepared based on 3 separate populations (PK/PD, Group D-Denovo & Group D-527.51). Group D-Denovo includes patients from PK Phase & additional subjects & Group D-527.51 Rollover includes patients who successfully completed tamsulosin HCl Study 527.51
755976|NCT00340678|Subjects were enrolled between 1996 and 2001, the last biopsy was performed in 2007, and morphometric evaluation was completed in 2012.|Of 313 patients with type 2 diabetes who were screened, 79 were ineligible, 50 declined to participate, and 14 had other reasons that prevented participation despite meeting eligibility requirements.
755977|NCT00340379||
755978|NCT00339833|Recruitment location: clinical research unit at the NIDKK (Phoenix, AZ, USA)|Upon admission, all participants were placed on a weight maintaining diet (containing 50% of energy as carbohydrate, 30% as fat and 20% as protein). Body composition was measured by dual-energy x-ray absorptiometry. At least 3 days after admission and after a 12 h overnight fast a 2-h 75 g OGTT was performed to exclude diabetes.
755979|NCT00339183|First patient enrolled 30 June 2006; Last patient enrolled 13 March 2008.|
755980|NCT00339144||
755981|NCT00339079|The recruitment period was from October 2003 to July 2008. Participants were recruited via advertisements to the general public (e.g., newspaper ads).|
755982|NCT00339040|Between October 11, 2006 and November 22, 2006 130 participants were enrolled at 34 clinical sites from US & Puerto Rico.|Participants were stratified by CD4% criteria. Four participants were randomized but did not receive the study treatment. The study analyses were based on 126 participants who received the study treatment.
755983|NCT00338988|The recruitment period: August 28, 2003 to July 31, 2006. All participants were recruited at UT MD Anderson Cancer Center.|Following enrollment, one of the forty-four participants was found to be ineligible and never assigned to a group.
755984|NCT00338962||
755985|NCT00338949|Recruitment started 06/01/2006. Eligibility: nondiabetic, overweight/obese psychiatrically stable adult outpatients in San Diego with schizophrenia/schizoaffective disorder, on risperidone or olanzapine. Recruitment ended: 12/31/2009|Exclusions: unstable housing, psychiatric hospitalization in the past 90 days, ongoing substance abuse (except nicotine), history of diabetes mellitus, pregnancy, refractory schizophrenia, prior failure of or intolerance to ziprasidone, oral glucose tolerance test indicative of diabetes mellitus, or corrected QT interval ≥ 500 msec on EKG.
755986|NCT00338884||
755987|NCT00338806|Recruitment dates:10/06-5/10 Location: New York State Psychiatric Institute (mental health research and patient care)|Enrolled subjects were excluded from the trial because they were found to be either too symptomatic or asymptomatic
755988|NCT00338741|35 physicians in clinical practice in the United States participated in the Registry. Physicians were practicing obstetricians and neurologists who evaluated the subjects as part of their clinical practices.Between 30 Sep 2002 to 15 Feb 2008, 207 subjects were contacted about the Registry. Enrollment was terminated on 07 Dec 2007.|
755989|NCT00338728|Participants were recruited from November 2003 to October 2008. The participating subjects must sign the consent document pertaining to the study and meet all the eligibility criteria as mentioned in the protocol, before initiating on the study treatment.|The study start date is the activation date which is October 2, 2003, but the first patient consented was on November 3, 2003.
755990|NCT00338598|Participants were recruited from the VA hospital in West Haven, CT and the Community Mental Health Center in New Haven, CT through word of mouth, advertisement and clinician referrals.|Twenty men, who met DSM IV criteria for schizophrenia or schizoaffective disorder, who also met DSM IV diagnosis of alcohol dependence with at least one recent episode of heavy drinking (defined as more than 5 drinks/drinking episode) over the past 14 days participated in the study. The participants were in stable treatment for at least 2 weeks.
755991|NCT00338455|Of the 16 participants randomized in the study, 1 participant randomized to receive nesiritide was not administered study drug due to investigator decision.Summaries of baseline characteristics are based on the 16 participants who were randomized in the study. Safety and efficacy analyses were based on the 15 participantswho received study drug.|
755992|NCT00338286||Participants in safety data were grouped as treatment actually received (3 were assigned to SOC but received epoetin alfa; 2 were assigned to EPO, but received SOC) so, 1 more to EPO (1051) 1 less in SOC (1045) actually received treatment. Efficacy, safety were analyzed by 1050 (EPO), 1048 (SOC), 1051 (EPO), 1045 (SOC) respectively.
755993|NCT00338104|75 patients with hyperglycemia were recruited from the inpatient service at Northwestern Memorial Hospital between August, 2004 and May, 2005.|Patients had to be on a continuous insulin infusion to treat hyperglycemia prior to randomization
755994|NCT00338039|Recruitment Period: September 15, 2005 to June 29, 2009. All recruitment done at hospital and medical clinics.|
755995|NCT00337987||
755996|NCT00337935||
755997|NCT00337818||Only 8 subjects came to Month 18 whereas most of the subjects came to Month 24. Therefore, no separate analysis at Month 18 was prepared; data for Month 18 outcome variables were incorporated into Month 24 analyses.
756296|NCT00320541||219 patients were screened; 28 patients were screen failures and were not assigned treatment.
755998|NCT00337779|Study was conducted according to laws, regulations and administrative provisions related to implementation of Good Clinical Practice as applicable by legislation directives and Standard Operating Procedures. Subjects entered study after being informed and given time to contemplate consent. Enrollment began September 2006 and completed May 2007|All subjects underwent evaluations including vital signs (blood pressure, pulse, and temperature,) adverse events, concomitant medications and neurological evaluation prior to study entry.
755999|NCT00337727|"This study was conducted at 58 investigative sites worldwide. The first patient entered the study on 16-Jan-
~2007 and the last patient's last visit was on 28-Oct-2008."|Cancer patients naïve to both moderately and highly emetogenic chemotherapy (MEC and HEC, respectively) scheduled to receive an initial course of MEC for confirmed malignant disease. The study focused on patients receiving an initial cycle of MEC (Cycle 1).
756000|NCT00337675|"Patients were recruited from 111 centers worldwide.
~Patient screening began 16-Oct-2006 and the first patient was randomized on 3-Nov-2006.
~The last patient's last visit was completed on 12-Aug-2009."|"1979 screened; 208 excluded.
~Randomized patients met the following criteria: age 6-71 months, a history of episodic asthma symptoms that ranged between 2 and 6 episodes, depending on age, that were separated in time by periods without asthma symptoms. Patients had at least 1 corticosteroid treatment or were hospitalized for asthma at least 1 time."
756001|NCT00337662||Study Period I was the screening period prior to enrollment. Study Period II was a 2-week open-label lead-in period of risperidone 2-6mg/day, at which time determination of early onset status was determined. Study Period III was a 10-week, double-blind therapy period.
756002|NCT00337610|First Patient In: 21-Aug-2006; Last Patient Last Visit: 15-Aug-2007; Twenty-four medical clinics worldwide (12 in the United States, 2 in Israel, 3 in Mexico, 3 in Peru, and 4 in Austria).|Patients 18-78 years on oral single antihyperglycemic agent (AHA) (hemoglobin A1C [A1C] ≥8%) or metformin-based dual combination therapy (A1C 7.5-10.5%) were eligible to participate. Eligible patients underwent an up to 12-week metformin dose-titration/dose-stable period followed by a 2-week placebo run-in period prior to randomization.
756003|NCT00337571||
756004|NCT00337467||63 participants were enrolled in this study; 2 were never treated (1 no longer met study criteria and 1 concomitant medication not permitted).
756005|NCT00337428||The study enrolled healthy participants, 11-17 years old, with 0 lifetime sexual partners, vaccinated against diphtheria, tetanus, pertussis and polio but had not received the vaccine in the past 5 years or any prior human papillomavirus (HPV) vaccine. Additional inclusion and exclusion criteria applied.
756006|NCT00337350|Subjects were recruited from the Freedom Trial Clinic at the Erich Lindemann Mental Health Center and were studied at the Mallinckrodt General Clinical Research Center (GCRC) at Massachusetts General Hospital (MGH), Boston.|
756007|NCT00337285||Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse for up to 1 year.
756008|NCT00337272|10 community oncology research sites across the United States within Accelerated Community Oncology Research Network (ACORN) participated in this study. Enrollment started in August 2006 and closed in August 2008.|After consent, subjects underwent a 2 week screening period to see if they met the criteria for insomnia and to assess compliance with daily Interactive Voice Recognition System (IVRS) calls.
756009|NCT00337207|Patients were recruited from the Neuro-Oncology outpatient clinic and inpatient services between the dates of March 16, 2006 and June 5, 2008.|
756010|NCT00337194|From April 2006 to December 2007 10 institutions recruited 30 participants to this trial.|
756011|NCT00337181||
756012|NCT00337168||
756013|NCT00337129|From June 2006 to December, 2007 a total of 42 patients were enrolled from SWOG institutions|2 patients are not eligible before assignment.
756014|NCT00337103||A total of 1276 participants were enrolled and screened, of which 174 were screen failures and 1102 were randomized in the study. Of the randomized participants, 1090 participants received the study treatment.
756015|NCT00337077|Participants were recruited from ECOG member institutions between November 29, 2006 and August 5, 2009.|
756016|NCT00336973||
756017|NCT00336895||30 participants were screened only 29 participants were enrolled
756018|NCT00336856||
756019|NCT00336817||
756020|NCT00336700||
756021|NCT00336583|A total of 27 patients were enrolled between April and December 2006 from eight institutions in South Korea.|Patients with symptomatic central nervous system involvement and pregnant or breastfeeding women were excluded. Patients with grade 2 or more peripheral neuropathy at the time of study entry were also excluded.
756022|NCT00336544|Subjects were recruited globally from July 2006 through May 2007.|In the clarithromycin treatment arm, one subject was enrolled and randomized to a blinded treatment but discontinued from study prior to administration of the first dose of drug. Thus, while official enrollment totaled 522 subjects, only 521 were randomized and dosed with blinded study drug.
756023|NCT00336505|Subjects were recruited globally from January 2006 through October 2007.|In each treatment arm, one subject was enrolled and randomized to a blinded treatment but discontinued from study prior to administration of the first dose of drug. Thus, while official enrollment totalled 584 subjects, only 582 were randomized and dosed with blinded study drug.
756024|NCT00336492||
756025|NCT00336479||A total of 263 subjects were enrolled, of which 13 subjects discontinued the study prior to study drug administration. A total of 250 subjects started treatment.
756026|NCT00336323|Thirty-six clinical sites across the United States recruited 121 subjects (109 met criteria for inclusion in the analyses) between June 2006 and August 2006.|Unless otherwise noted, differences in number of Participants at different visits reflect a missed visit, not a drop-out.
756027|NCT00336284||
756028|NCT00336232||
756029|NCT00336024|Children less than 36 months with high risk medulloblastoma/PNET were enrolled in the study. The first eligible patient was enrolled on October 22, 2007 and the last patient was enrolled on April 23, 2014.|This is a Phase 3 randomized trial designed to determine whether or not the addition of high dose Methotrexate will achieve a higher complete response rate.
756030|NCT00335972||
756031|NCT00335959||
756073|NCT00333437|8 patients were screened at one clinical site (UCSF) in the United States|One patient screened for enrollment did not meet eligibility criteria
756032|NCT00335829|Patients with a diagnosis of unresectable hepatocellular carcinoma (HCC) were enrolled on this protocol to receive a combination of intravenous bevacizumab and transarterial chemoembolization (TACE) therapy. A total of 26 patients were enrolled on protocol; 10 patients at Northwestern University and 16 at Johns Hopkins University.|
756033|NCT00335777|Participants were recruited from our office practice or surrounding community and screened at the Jefferson Headache Center between 8/21/06 and 6/18/08.|Eligible subjects were enrolled in the study and dispensed open label study medication at the end of the screening visit.
756034|NCT00335764|patients enrolled from 2006 - 2009 Patients accrued from comprehensive outpatient cancer centers|
756035|NCT00335738||
756036|NCT00335725||
756037|NCT00335556||
756038|NCT00335517||
756039|NCT00335504|142 subjects were pre-registered through 10 Cancer Prevention Network (CPN) member organizations from April 2006 to August 2008.|57 subjects were excluded from the trial before assignment to groups: 13 did not have baseline Magnification chromoendoscopy (MCE), 33 had < 5 rectal ACF, 8 did not meet eligibility criteria, and 3 were withdrawn.
756040|NCT00335478||
756041|NCT00335452|25086 patients were enrolled and randomized between June 2006 and August 2009 in 597 sites in 39 countries. Because the observed overall blinded event rate was substantially lower than expected, the number of patients to be enrolled was increased from 18000 to 20000, then to 25000.|Treatment assignment was performed through an automated voice randomization service (AreS). At the same time, the AReS provided allocation to a Clopidogrel treatment regimen according to a pre-defined randomization list and to a ASA dose according to a factorial design.
756042|NCT00335322||
756043|NCT00335283|The PI and/or study coordinator or other GI research nurses will meet with the patients referred by Vanderbilt's Asthma, Sinus and Allergy Program. The patients will be given the consent form to read, the document will be reviewed, and all questions will be answered.|
756044|NCT00335257|Overall, 91,474 patients were recruited for the INAS-OC study. Of these, 6,365 participants were excluded due to protocol violations.|
756045|NCT00335153||
756046|NCT00335140|Participants were recruited from ECOG-ACRIN member institutions starting 12/21/2006. The study was suspended 2/24/2010 for interim analysis. After the interim analysis, it was determined that the goals of the study had been met and the study was closed on 4/12/2013.|
756047|NCT00334958||
756048|NCT00334893|Protocol Open to Accrual 4/17/2006 Primary Completion Date 3/13/2012 Recruitment Location at medical clinic|
756049|NCT00334815||
756050|NCT00334802||
756051|NCT00334737||
756052|NCT00334633|women attending a sexually transmitted disease (STD) clinic with symptomatic bacterial vaginosis (BV)|
756053|NCT00334542|Participants were required to have good performance status, intact contralateral breast, and be at least 3 months from planned local and systemic adjuvant treatment.|
756054|NCT00334295||
756055|NCT00334282||
756056|NCT00334204|58 parcicipant recruited, 2 excluded due to missing data from analysis|
756057|NCT00334113||Of the 89 participants were enrolled in this study, only 66 participants were randomized. Of the difference, 18 were determined to be ineligible (17 for medical reasons, 1 for other reasons), and 5 participants dropped out before randomization.
756058|NCT00334074|Patients were recruited after the initial IRB approval in september 2004 at Baylor University Medical Center. Enrollment was closed in october 2006. The study was completed Including follow up in February 2007.|
756059|NCT00334061|From June 19, 2006 to June 5, 2007 a total of 856 patients were screened of which 125 patients were enrolled at 24 centers in Europe and the United States.|
756060|NCT00333983|147 community-dwelling adults with a diagnosis of chronic stroke were referred for study criteria screening by local VA stroke clinics and PT/OT clinicians. Community study advertisements and flyers were also utulized during this recruitment period that started October 2006 and ended December 2009.|Participants were excluded prior to randomization if they did not meet inclusion/exclusion criteria. Some candidates declined after learning of the study length and schedule committment.
756061|NCT00333970||103 participants were enrolled. Of those, 75 were found eligible, completed baseline assessments and were then randomized to either Arm 1 (n=50) or Arm 2 (n=25). The remaining 28 participants were either discontinued from the study by the PI or chose to withdraw prior to randomization.
756062|NCT00333879|The 4 totally blind Participants were recruited over three months (April - June) 2009 from the Atlanta Center for Visual Impairment.|All 4 subjects were accepted for the study. None were excluded.
756063|NCT00333866|Recruitment from 73 centers in North America [Canada (12) and Mexico (4)], South America [Venezuela (3)], Europe [Denmark (2), France (5), Germany (5), Italy (6), Netherlands (5), Portugal (4), Spain (4), Sweden (4), Switzerland (3) and United Kingdom(5)] and Asia [India (4) and Korea (3)] and Australia (4).|
756064|NCT00333840||
756065|NCT00333814||
756066|NCT00333801|From 2006 to 2010 Veterans with PTSD at the Tuscaloosa VA Medical Center were enrolled in a 12-month, prospective randomized comparison of IPS Supported Employment and treatment-as-usual Vocational Rehabilitation Program (VRP).|100 Veterans were enrolled; 85 were randomized to IPS-SE (n=42) or VRP (n=43) and followed 12-months. 15 participants were excluded: 2 did not have PTSD, 2 lived >100 miles away, 3 withdrew consent, 4 had exclusionary diagnosis, and 4 were not eligible to be enrolled in the VRP. Participants were allowed to continue all other treatments for PTSD.
756067|NCT00333788|This study started in October 2006, with recruitment in the United States, Austria, Belgium, Canada, France, Germany, Italy, Spain, Sweden, Switzerland, the United Kingdom and the Netherlands. This study completed in April 2010.|The summary of Participant Flow is based on the All Subjects Population.
756068|NCT00333775||21 participants randomized to the placebo group received bevacizumab 7.5 mg/kg (n=5) or 15.0 mg/kg (n=16). Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.
756069|NCT00333762||
756070|NCT00333710||
756071|NCT00333619||
756072|NCT00333606||This was the crossover study with 60 participants. Each participant underwent 2 conditions: verum and sham acupuncture within an interval of at least one week.
756074|NCT00333359|Participants completing one of four parent studies (110963 [NCT00298623], 111460 [NCT00365352], 111462 [NCT01332305], and 111463 [NCT01332318]) were eligible to enroll in Study 111490 (NCT00333359) if eligibility criteria were met.|
756075|NCT00333229||
756076|NCT00333177||32 patients who were enrolled in the study dropped out during the initial medication stabilization period prior to the start of randomized treatment resulting in 60 being assigned to the randomized treatments.
756077|NCT00333138||
756078|NCT00332839|Renal transplant recipients at least 6 months post transplantation were randomized to the CNI group or Certican group. Post 12 months, participants entered a follow-up phase for an additional 48 months. Thirty-three participants in the CNI group and 34 participants in the Certican group had a month 60 follow-up status.|
756079|NCT00332722|Consecutive new patients presenting to interventional pain management practice with neck pain without suspected disc herniation or radiculitis.|
756080|NCT00332709||Total Randomized participants were 83. 2 patients were enrolled but never received study medication. Hence, 81 were included in the safety population.
756081|NCT00332696||
756082|NCT00332644||
756083|NCT00332605|July 2006 - September 2009|
756084|NCT00332579||
756085|NCT00332488|31 May 2006 (first subject enrolled) to 03 Mar 2008 (last subject completed. Multi-national trial conducted in Argentina, Brazil, Canada, Chile, Czech Republic, Mexico, Poland, Russian Federation, Spain, Ukraine, and USA.|2 week screening period prior to randomization. 1512 patients screened with 528 patients randomized. 977 patients failed screening criteria, 9 subjects passed screening but were not randomized, 2 subjects failed screening but were randomized.
756086|NCT00332462||
756087|NCT00332332|Participants were enrolled from 17 March 2006 through 30 June 2008|
756088|NCT00332241||
756089|NCT00332202||
756090|NCT00332189|Subjects had to have previously participated in study PKU-004 (NCT00225615) or PKU-006 (NCT00272792)|The last assessment obtained in PKU-004 or PKU-006 could be used to determine eligibility for this study provided assessment was conducted fewer than six weeks prior to PKU-008 Day 1.
756091|NCT00332163|Participants enrolled at 36 sites in the United States between 17 April 2006 and 28 September 2007.|Participants were stratified to receive either a FOLFIRI and panitumumab regimen or an irinotecan and panitumumab regimen based on the investigator's discretion according to local standard of care. Participants were then randomized to receive either a pre-emptive skin treatment or reactive skin treatment regimen for a 6-week skin treatment period.
756092|NCT00331864|"The study population consisted of two groups, one group being naïve to ranibizumab (Non-ANCHOR patients) and the other group were those patients who previously were treated with ranibizumab in the ANCHOR study (NCT00061594; ANCHOR patients)."|
756093|NCT00331799||
756094|NCT00331773||
756095|NCT00331760||
756096|NCT00331682||
756097|NCT00331630|The study was opened to accrual May 4th 2006 with the first patient being treated on November 10th 2006. 30 patients were enrolled and treated on the study with the study being closed to new enrollment on June 10th 2009 having reached its accrual goal.|
756098|NCT00331552||
756099|NCT00331422||
756100|NCT00331409|Initial recruitment began in Feb 2006 and ended in Dec 2007. 19 patients were put on study during that time frame. These patients came from OHSU oncology clinics or referrals to OHSU.|During the first stage, patients not assessable for progression-free status at 3 months due to study discontinuation for any reason except death or progression were replaced only for purposes of determining continuation to the second stage.A total of 19 patients were enrolled in the first stage 15 evaluable patients and 4 patients who were not.
756101|NCT00331344|Patients (incl. currently followed in these practices, as well as those referred from outside providers) will be screened for interest and eligibility by medical oncologists from UCSF Urologic Oncology Practice CCC, UCSF-VA Medical Cntr, OHSU Cancer Inst., MD Anderson Cancer Cntr, UMich Comprehensive Cancer Cntr and the Portland VA Medical Cntr.|
756102|NCT00331162||
756103|NCT00331006|Subjects were recruited at clinical sites and Hemophilia Treatment Centers participating in the study. The recruitment period began in August 2006 and continued through November 2011.|
756104|NCT00330967||
756105|NCT00330928|Subjects were recruited from patients presenting to the cardiac catheterization laboratory for scheduled elective percutaneous coronary intervention. Subject's medical history and angiographic coronary anatomy were used to evaluate eligibility.|
756106|NCT00330915||
756107|NCT00330876||
756108|NCT00330863||357 individuals consented to participation. However, 52 were either ineligible, withdrew consent, or lost to followup. Therefore, 305 individuals were randomized.
756109|NCT00330759|Participants were enrolled from 21 June 2006 through 16 May 2008|A total of 1779 participants were enrolled in the study. Three participants from one site were excluded from all analyses because Institutional Review Board (IRB) review activities and oversight were not ensured.
756110|NCT00330733|Participants were veterans aged 21-75 years with impaired fasting glucose (i.e. ≥5.6 but <7 mmol/l) or impaired glucose tolerance (2 h glucose values ≥7.8 but <11.1 mmol/l) during a standard 2 h 75 g OGTT. Study participants were recruited from clinics and hospitals throughout the Phoenix and Boston VA Health Care systems.|After enrolment there were 1 week screening, 3 week single-masked placebo run-in (to assess compliance) and 12 week randomised, double-masked treatment periods, with participants randomised 1:1 to receive salsalate or placebo. 78 individuals entered the run-in phase.
756111|NCT00330681||
756112|NCT00330668|All subjects that completed study MS301 (NCT00125164) were eligible to enter this Phase 3b, open-label, extension study in prepubertal and pubertal male and female subjects with growth failure associated with primary insulin-like growth factor-1 deficiency (IGFD). This study (MS306) was terminated early by the sponsor on 01 December 2009.|As subjects entered MS306 whilst MS301 was continuing, dosages were adjusted in MS306 after MS301 data became available. Baseline study data for MS306 were taken from the data collected for Visit 9 (Month 12) of study MS301.
756113|NCT00330616||
756114|NCT00330564|Recruitment Period: 5/19/2006 to 3/17/2010. Participants recruited from routine appointments at a Comprehensive Cancer Center.|Study terminated early due to slow accrual.
756117|NCT00330421|This phase II study enrolled pts with metastatic or inoperable sarcomas. Additional eligibility criteria: at least one site of measurable disease, at least one superficial palpable tumor (>1cm) amenable to biopsy, age ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and no prior sorafenib therapy.|Additional eligibility criteria included: at least one site of measurable disease by radiologic imaging, at least one superficial palpable tumor (>1cm) with no overlying viscera amenable to biopsy, age ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and no prior sorafenib therapy.
756118|NCT00330382|A total of 513 people were screened for participation across all 8 performance sites, of which 188 (37%) were ineligible and 325 were consented.|Of 325 consented, 157 (48%) completed the run-in period but 25 declined to continue, resulting in 132 randomized patients.
756119|NCT00330343|75 participants were consented, but only 64 participants participated in this study and were placed in the experimental arm.|
756120|NCT00330187||
756121|NCT00330174|Participants were recruited from May 2006 to June 2008. The study was conducted at three sites including a rural community treatment program in South Carolina, an urban community treatment program in New York City, and at an academic setting at McLean Hospital in Belmont, MA|
756122|NCT00330161|Participants were recruited at 5 medical centers between May 2006 and February 2007.|
756123|NCT00329901|Subjects were recruited from 14 centers in Italy.|All enrolled subjects participated in the trial.
756124|NCT00329849|Subjects were enrolled at 3 study centers in Argentina.|All enrolled subjects were included in the trial.
756125|NCT00329836|Subjects with cluster headache recruited from Jefferson Headache Center office practice or community. First subject enrolled 7/5/05. Last subject enrolled 6/9/06.|
756126|NCT00329797||
756127|NCT00329784|Participants between 4 and 11 months of age with pre-existing allergy to egg and/or severe eczema were recruited in the United Kingdom between December 2006 and May 2009.|Participants were stratified into cohorts based on a skin prick test for peanut allergen. Participants were either negative (no measureable wheal after test) or positive (a wheal measuring between 1 and 4 mm in diameter). Participants were then randomized into treatment groups.
756128|NCT00329771||
756129|NCT00329745||
756130|NCT00329732||
756131|NCT00329719||
756132|NCT00329641||
756133|NCT00329602|Participants (par.) could enter the Open-Label (OL) phase at the end of the Double-Blind (DB) phase. If a par. did not complete the DB phase due to lack of efficacy, he/she could also be considered for entry into the OL phase if the investigator considered it appropriate and the par. met the protocol-defined criteria in describing lack of efficacy.|
756134|NCT00329550|Recruitment into this extension study was between March 2006 and April 2008. Of the 26 hospitals and medical centers throughout Japan in the main study, 16 sites went on to enter subjects in this extension study.|To enter this single-group extension study, C87047 (NCT00329550), subjects had to have responded at Week 6 of the double-blind main study, C87037 (NCT00291668). Recruitment details are provided for the 40 subjects who entered this extension study by the three possible treatment sequences received across both studies.
756135|NCT00329524||
756136|NCT00329433||
756137|NCT00329420|Non-responders at Week 6 of the double-blind main study, C87037 (NCT00291668) could enter this single-group open-label extension study, C87048 (NCT00329420). Recruitment into this extension study was between May 2006 and May 2008. Of the 26 hospitals in the main study (NCT00291668), 16 sites went on to enter subjects into this extension study.|Subjects who responded to re-induction (Week 14 visit) in this extension study could enter the 4-weekly dosing phase. Efficacy data are based on these 26 subjects. However, adverse event data are based on all 46 subjects who entered this extension study. Data are presented by the three possible treatment sequences received across both studies.
756138|NCT00329407||
756139|NCT00329303|The study started to enroll patients in April 2006 and concluded in May 2007.|Participant Flow refers to the Intention-to-treat population.
756140|NCT00329238||
756141|NCT00329160||Observation Period :Prior to study-related activities, all subjects will sign an informed consent form. IVUS and CAG is performed prior Treatment Treatment Period: Eligible patients started treatment; rosuvastatin 2.5 mg once daily; those whose LDL-C remained >80 mg/dl after 4 wks of treatment, the dose can be titrated to a maximum of 20 mg/day
756142|NCT00329108|47 centers in Europe.|After a wash out period of at least 24 hours, patients were randomized to ziprasidone or olanzapine.
756143|NCT00329030||
756144|NCT00328926||
756145|NCT00328861||
756146|NCT00328783||
756147|NCT00328770|All adults receiving a liver transplant between December 1996 and March 2006 who had hepatocellular carcinoma and were treated with sirolimus as part of their immunosuppression after their transplant were included in this trial.|
756148|NCT00328627|Participants took part in the study at 327 investigative sites in 20 countries from 31 May 2006 to 17 March 2008.|Participants with a diagnosis of type 2 diabetes who were inadequately controlled on a regimen of metformin alone were equally randomized to 1 of 12 double-blind treatment groups.
756149|NCT00328614||
756150|NCT00328562||
756151|NCT00328510||
756152|NCT00328263|2151 patients were screened for eligibility. 437 patients were randomized for the study between March 2006 and October 2006.|Inclusion & exclusion criterias were used to randomized patients. Patients were followed for an additionnal 21 days after treatment ended.
756153|NCT00328198||109 patients screened and 86 enrolled and treated.
756154|NCT00328172||
756155|NCT00328094|Perioperative period in Beth Israel Deaconess Medical Center, West Campus was the only location for the recruitment.|252 were assessed for eligibility. 10 did not meet inclusion criterion.
756156|NCT00328042||
756157|NCT00328016|102 Subjects responded to advertising and were assessed for eligibility. Forty-four were enrolled and randomized. 23 were randomized to guided breathing and 21 were on the Control arm.|
756158|NCT00327717||
756159|NCT00327470||
756191|NCT00325442|354 subjects were randomized with 350 subjects receiving a dose of study drug and subsequently analyzed from 20 October 2006 to 17 September 2008 at 70 sites across the United States, Canada, Europe, Israel, and Australia.|
756160|NCT00327444|Fifty-eight (58) participants from a total of 23 sites in 7 countries were enrolled in the study.|55 were randomized (started population). 3 participants were not randomized but they were treated, and permanently withdrawn from the study due to disease progression (1 participant), fatal disease progression (1 participant) and a treatment emergent adverse event (1 participant).
756161|NCT00327392|This study recruited at 12 study centers in the US during the period of 22-Jun-2006 to 01 Mar 2007.|All subjects received fentanyl at an initial dose of 50 μg as an analgesic pretreatment 5 minutes prior to the administration of the initial dose of fospropofol disodium (also referred to as LUSEDRA and formerly known as AQUAVAN). After fentanyl administration, the venous catheter was flushed with 2 mL of sterile saline solution.
756162|NCT00327340|Participants were recruited at 10 institutions with a primary focus in oncology and located in Canada. The first subject was randomized on July 25, 2006. The last subject completed treatment on August 6, 2008 and the last survival follow-up visit was on August 13, 2010|A total of 70 subjects were enrolled. 45 subjects were randomly assigned to treatment (21 to OGX-011/ docetaxel and 24 OGX-011/ mitoxantrone). An additional 25 subjects were enrolled under Amendment 2 and assigned to OGX-011/docetaxel retreatment. One subject was found to be ineligible and was not treated.
756163|NCT00327171|218 participants were randomized in this study. Three participants in the 2 mg/kg treatment group did not receive any study medication.|
756164|NCT00327015||
756165|NCT00326963|A total of 142 participants were enrolled in this study conducted from 6 March 2006 to 20 April 2007 at 33 centers to be investigated in the United States.|A total of 142 participants were randomized, of which 140 received the study drug. A total of 2 randomized participants did not receive study drug.
756166|NCT00326950|This study was recruited at 1 center in Japan during the period of May 2006 to Jan 2008|
756167|NCT00326924||
756168|NCT00326911|Patients were recruited from a population of pancreatic cancer patients treated at investigational centers.|Prior chemotherapy, hormonal therapy, radiation therapy in the adjuvant setting were allowed, provided that the last date of therapy was at least 6 months prior to randomization.
756169|NCT00326898|The study was activated on April 24, 2006 and closed to accrual on September 1, 2010, after accrual of 1943 patients.|
756170|NCT00326885|40 patients were recruited and 32 patients were treated and evaluable. For analyses, there were 32 patients in the Full Analysis Set (FAS), 14 patients in the Per-Protocol (PP) population, and 32 patients in the Safety population.|Eligible patients must have undergone at least 1 therapeutic paracentesis (the most recent paracentesis) within 4 weeks prior to the baseline paracentesis.
756171|NCT00326872|From 8/29/2006 until 7/31/2009, 26 patients were accrued.|All 26 patients accrued were evaluable for the primary endpoint.
756172|NCT00326781|Recruitment occurred between December 1999 and July 2003.|
756173|NCT00326716|Pregnant participants were enrolled at 6 sites: United States (2), South Africa (3), and Puerto Rico (1).|Of the 69 enrolled participants, 28 mothers were not treated. Failure to continue to meet enrollment criteria resulting in discontinuation in 24/28 participants and 4 were not treated: 1 poor/no compliance, 1 met exclusion criteria, 1 was ARV naive subject with HIV RNA < 400 c/mL, and 1 was unable to comply with study procedures.
756174|NCT00326612|Recruited from a pediatric Neurology clinic.|
756175|NCT00326599|One hundred-and one (101) participants were enrolled between June 15, 2007 and December 5, 2008. Data for this report were frozen on September 13, 2011.|Five participants were excluded from all analyses due to withdrew consent or never received study treatment: 1 lead-in arm I; 2 phase II arm I; and 2 phase II arm II. The starting cediranib dose of 45 mg was not tolerable and was reduced to 30 mg once daily on a continuous schedule for the phase II portion of the study.
756176|NCT00326495||
756177|NCT00326417|Participants were enrolled from February 2006 to August 2007 for Phase I of the trial. Phase II opened in November 2007 and closed to accrual on December 2, 2013.|
756178|NCT00326209|Enrolled participants were rolled over from a double-blind lead-in study (MPUC3003 [NCT00744016 ] or MPUC3004 [NCT00767728 ]), or were new participants with demonstrated remission of ulcerative colitis (UC) were enrolled in this study.|A total of 393 participants were enrolled into the study. Of the participants included in the study, 280 participants were rolled over from a lead-in study (MPUC3003 or MPUC3004) and 113 were new participants.
756179|NCT00326196|The study recruitment occured at 23 VA medical centers and thestudy recruitment lasted from 8/25/2006 thru 3/24/2010.|Study participants were were pre-screened by Cath lab. The remaining participants were consented and screened for study eligibility.
756180|NCT00326183|"18 investigators in the United States; Date of first subject visit: 26-Mar-2007.
~Date of last subject visit: 14-Nov-2007."|
756181|NCT00326170|Recruitment Period: 06/10/05 through 11/17/06. All participants recruited at UT MD Anderson Cancer Center.|
756182|NCT00326118||Total of subjects completed in the previous period does not necessarily correspond to the amount of subjects who came back for the follow-up. These subjects were considered lost-to-follow-up.
756183|NCT00326001|A total of 463 patients were enrolled in the AURUM 8 study from June 2004 to March 2007 in 19 clinical centers in Germany and the Czech Republic.|No exclusion before assignment
756184|NCT00325897||
756185|NCT00325819|Recruitment and enrollment took place between May 2006 and September 2009. Children potentially eligible for study participation were identified from the Group Health data systems and parents were mailed a letter providing information on the study.|No significant events followed participant enrollment prior to group assignment.
756186|NCT00325780||
756187|NCT00325754||
756188|NCT00325598|The study opened to participant enrollment on 02/14/2006 and closed to participant enrollment on 04/11/2012.|
756189|NCT00325572|Recruitment was begun in January, 2006. The participants were recruited from a developmental pediatrics outpatient clinic and comparison patients were recruited from a general pediatrics clinic and an allergy clinic.|The Modified Checklist for Autism in Toddlers and the Social Responsiveness Scale were used as screens. 3 children were excluded from the comparison group because of scores outside the typical range. 4 children were excluded from the autism study group because they failed to meet criteria for autism using the Autism Diagnostic Interview-Revised.
756190|NCT00325468|Subjects who successfully completed the double-blind, randomized, 4-year dose-ranging parent study 20010223|
756352|NCT00316862|Between February 2006 and August 2011, 82 participants were recruited to this study.|
756192|NCT00325416|"Phase I: 129 (70 Group A and 60 Group B) participants were enrolled during the Phase I portion.
~Phase II: 48 (40 Group A and 8 Group B) participants were enrolled during the Phase II portion.
~Both Phases: 72 Phase I participants were still on study when Phase II began."|
756193|NCT00325403|349 subjects participated in the study from 24 October 2006 to 29 April 2011 at 52 of 77 sites across the United States, Puerto Rico, Canada, Europe, Israel, India, Mexico, and China. The primary endpoint was analyzed using the primary analysis population which included 228 subjects who had access to 0.25 mg tablets at the time of randomization.|
756194|NCT00325234||
756195|NCT00325195|Rheumatology practices across the US, Canada and Mexico|13 subjects were randomized but withdrew before intervention. These subjects were not part of the modified Intent to Treat Population, which included only subjects who received at least one dose of study drug.
756196|NCT00325156||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
756197|NCT00325143||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
756198|NCT00325130||
756199|NCT00325078||
756200|NCT00325039|Recruitment took place between April 2006 and June 2008. Patients were recruited from nine clinical sites. TOMUS (Trial Of Mid-Urethral Slings) was conducted by the Urinary Incontinence Treatment Network (UITN), a cooperative network consisting of urologists and urogynecologists at 9 clinical centers and a biostatistical coordinating center.|3521 women were screened for eligibility. 1513 did not meet inclusion criteria; 1259 were eligible for inclusion in the study but were excluded (1001 declined to participate, 258 excluded for administrative reasons). 749 women provided written consent; of these 152 were excluded (63 ineligible, 66 withdrew consent, 23 administrative reasons).
756201|NCT00324987||
756202|NCT00324961||
756203|NCT00324896|Patients were recruited between 2006 and 2009, from the RWJMS movement disorder clinic and advertising to local support groups.|Patients who met inclusion and exclusion criteria were enrolled.
756204|NCT00324870||
756205|NCT00324857||
756206|NCT00324805|Patients were recruited between June 1, 2007 and September 20, 2013 from ECOG-ACRIN, SWOG, RTOG, CALGB, NCCTG, NCIC-CTG, NSABP, ACOSOG, and CTSU sites.|
756207|NCT00324753||
756208|NCT00324740|A total of 14 patients were enrolled between June 2006 and September 2010|
756209|NCT00324701||
756210|NCT00324675|recruitment at medical clinic and outpatient department|2 enrolled patients were excluded: one withdrew infromed consent, one developed anaphylactic reaction to sinistrin (used for renal function test)
756211|NCT00324649||
756212|NCT00324415||
756213|NCT00324350|The ACCORD trial has been described previously (Buse JB,et al. Am J Cardiol 99:21i-33i, 2007). Five of the 7 clinical center networks agreed to participate in the BONE ancillary study, including 54 of 77 clinical sites and 7,287 participants. The BONE ancillary study was initiated during the main recruitment for ACCORD (beginning in 2006).|
756214|NCT00324272|Patient recruitment occurred between 1.1.2003 and 31.12.2006. A total of 74 patients were recruited. All patients were followed up until 1.6.2010.|All 74 patients who were enrolled in the trial were followed up until 1.6.10 (unless they died prior to this date).
756215|NCT00324259|The study opened to participant enrollment on 08/03/2004 and closed to participant enrollment on 02/19/2008.|
756216|NCT00324233||
756217|NCT00324168|Between September 1, 2006 and February 22, 2010, 1,769 patients were screened for the trial and 500 patients were enrolled.|Common reasons for ineligibility include impending perforation (n=316, 25%), history of a corneal scar in the affected eye (n=123, 10%) and vision worse than 6/60 in the fellow eye (n=119, 9%).
756218|NCT00324155|The study was initiated on August 8, 2006. Primary endpoint (Survival) was evaluated on February 7, 2011 and again at completion of follow-up period, October 13, 2013. Participants with a histologic diagnosis of untreated, measurable, and unresectable Stage III or Stage IV malignant melanoma were eligible.|Of 681 patients enrolled, 502 were randomized, and 498 received treatment. Reasons for not starting treatment: 147 no longer met study criteria (including 3 who were randomized but did not receive treatment), 25 withdrew consent, 3 died, 2 had adverse events, 2 lost to follow-up, 2 poor compliance or noncompliance, 1 not reported, and 1 other.
756219|NCT00324116||
756220|NCT00324038|Primary care. March 2006 to Aug 2007|Screening for patient eligibility
756221|NCT00323882|Study initiated January 2006; Primary endpoint last visit September 2009; follow up period last visit July 2013 with data cut off September 2013. Male patients with castrate-resistant prostate cancer (CRPC) who met study criteria were enrolled.|75 participants enrolled and were assigned to treatment; 71 were treated. Reasons for the 4 participants not receiving treatment were not specified by the investigators. Ipilimumab was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose.
756222|NCT00323869||
756223|NCT00323739|Eighty-four patients with advanced kidney cancer were assessed for participation at multiple US clinics between August 2006 and November 2008.|Four patients did not meet eligibility criteria and were not treated.
756224|NCT00323635|Women 45 to 65 years old were mailed post-cards with the study telephone number and e-mail address. Subjects were assessed for eligibility. The PI determined eligibility based on the study criteria. Eligible subjects were informed about the study requirements, risks and benefits, and then required to read and sign a consent form.|Placebo responders were excluded after one week.
756225|NCT00323622|This current study NCT00323622, a follow-up (FU) study to the primary study NCT00197041, is aimed at vaccine safety assessment, and took place from Months 21 to 45 (Month 0 = Dose 1 administration of RTS,S/AS02A (GSK 257049) or comparator vaccine in the primary study).|Once re-enrolled, subjects in this study were allocated to the same groups as in the NCT00197041 study, as well as the same cohorts, e. a. Cohorts 1 and 2 whose subjects were followed for analysis of, respectively, malaria infection and disease.
756226|NCT00323609||
756258|NCT00322335|The follow-up timepoints include all subjects who came back for that timepoint. Therefore the amount of subjects who completed the previous timepoint does not correspond with the amount of subjects starting the following time-point per se.|
756353|NCT00316719||
756227|NCT00323557|Recruitment Period: December 9, 2004 to July 16, 2009. All participants were recruited at UT MD Anderson Cancer Center.|Of the 39 enrolled participants, four (4) participants withdrew consent and three (3) were ineligible thus all seven (7) were excluded from the trial before assignment to Pneumococcal Vaccine and Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) related treatment groups.
756228|NCT00323492||
756229|NCT00323479|Patients were included by an investigator-oncologist between 15 June 2006 and 31 December 2007|Patients were included by an investigator-oncologist who followed them up every 3 months over a period of one year (i.e., 5 visits). An investigator rheumatologist carried out the rheumatological evaluations at inclusion and then every 6 months over a period of one year (i.e., 3 visits)
756230|NCT00323453||
756231|NCT00323427||
756232|NCT00323414||
756233|NCT00323362|Seventeen patients were enrolled from April 2006 through October 2007 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer cancert, and two of its affiliate hospitals within the CINJ Oncology Group.|
756234|NCT00323310|Patients were recruited from April 2006 to July 2008 at 17 investigational sites. The blinded read was conducted from September 12, 2008 to September 26, 2008.|94 patients enrolled; 92 patients dosed.
756235|NCT00323297|This study was conducted at 29 active centers in 10 countries (10 centers in Germany, 5 centers in the United States of America [USA], 3 centers in France, 2 centers in Australia, Czech Republic, Italy, and Israel, and 1 center in Greece, Taiwan and United Kingdom [UK])|Participants were on bosentan therapy for 3 months prior. Participants were randomized to sildenafil or placebo. Part A study was double-blind phase (12 weeks) and Part B was 12 months open-label phase. 53 and 51 participants were randomized to placebo and sildenafil arm respectively. One participant in sildenafil arm did not receive any treatment
756236|NCT00323284|The study recruited subjects between April 2005 and February 2008. The main part of the study consisted of a randomized portion where subjects were randomized 1:1 to either iStent plus Cataract Surgery, or Cataract Surgery only. Following the randomized portion, addtional subjects were enrolled in a non-randomized portion.|Following screening, eligible subjects underwent a wash out of topical hypotensive medication prior to the baseline exam.
756237|NCT00323271|"Recruitment occured during April 2007 through September 2009.
~Participants were Veterans and nonVeterans recruited primarily through their providers in one of three treatment settings, namely the MS Clinics at the VA Connecticut Healthcare System and VA Boston Healthcare System and at the Yale MS Center."|1 subject enrolled into the study but was found to be ineligible before randomization.
756238|NCT00323258|Patients hospitalized at Duke University Hospital (Durham, NC) were screened for study enrollment from July 5, 2006, through July 2, 2009. To increase enrollment, the study was opened to enrollment at Southeastern Regional Medical Center (Lumberton, NC) on May 27, 2008.|After patients provided written informed consent, the study pharmacist collected baseline demographics, medical history, medication history, potential barriers to medication adherence, pharmacy name, physicians' contact information, and the Beliefs about Medicines Questionnaire (BMQ).
756239|NCT00323193||
756240|NCT00323115|Between May 2006 and February 2008, 60 patients were diagnosed with GBM at our institution. Of 11 patients who entered the study, 1 had a seizure with neurologic deterioration several weeks after leukapheresis and did not receive any DC vaccinations.|
756241|NCT00323063|This study was opened to accural on 5/1/2006 and was closed to accrual on 4/15/2011 due to slow accrual. Subjects were recruited through the Cancer Institute of New Jersey Oncology Group. We are reporting results on 49 eligible patients. One was not eligible for participation.|
756242|NCT00323037|The recruitment period was from April 2006 until August 2007.|
756243|NCT00322881|12 patients were enrolled between March 26, 2006 and January 2, 2008.|
756244|NCT00322868|All patients who will be approached for participation in this trial will first be identified using either Port CF (CFF Registry) or CF Center database. Once potentials are identified a chart review will be conducted to determine eligibility. Patients will approached at clinic for possible participation in the study.|Washout: A 4 week washout from chronic use of NSAIDs, corticosteroids and oral meds to treat diabetes will be required. Subjects will be excluded if they take these medication within 72 hours of Visit 1. Subjects using alternate month tobramycin for inhalation (TOBI) will need to be on an off cycle to participate in this study.
756245|NCT00322855||
756246|NCT00322842||
756247|NCT00322777||
756248|NCT00322712||
756249|NCT00322621||Study Period I was a 5-9 day Screening Phase. Study Period II was an 8 week Acute Therapy Phase. Study Period III was a 26 week Maintenance and Rescue Therapy Phase. Study Period IV was a 2 week Taper Phase.
756250|NCT00322556||
756251|NCT00322491||
756252|NCT00322465||
756253|NCT00322452|Males or females that had never smoked or were light ex-smokers, who had Stage IIIB or Stage IV adenocarcinoma of the lung and had not received any previous chemotherapy excluding non-platinum based adjuvant chemotherapy were randomised between 30 March 2006 and 9 October 2007. The study was carried out in Asian countries (including Japan & China).|112 patients (out of 1329) failed screening and were not randomized, the majority of patients who failed screening did not comply with inclusion / exclusion criteria. Other reasons were: patient withdrew informed consent; patient lost to follow up. One patient was not randomized for 'other' (non-specified) reason.
756254|NCT00322439||
756255|NCT00322387|Patients with NHL or MM eligible for the study were recruited from 5 centers in the United States. The first patient was enrolled (signed informed consent) in April 2004 and the last patient's last study visit was July 2006.|Forty-four participants were enrolled; four participants never received plerixafor treatment so are excluded from summary tables.
756256|NCT00322374||
756257|NCT00322348|Pre-menopausal women with Oestrogen Receptor Positive Advanced Breast Cancer were recruited between 25th April 2006 and 24th December 2007. 49 participants were randomised to ZOLADEX 10.8 mg and 49 participants were randomised to ZOLADEX 3.6 mg. One participant was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg.|53 of the151 screened participants were not randomised to treatment groups for the following reasons : 50 participants were incorrectly enrolled (i.e. did not comply with inclusions/exclusion criteria) and a bone scan was not performed for 3 participants.
756259|NCT00322309|Subjects were recruited at the Boston University Psychiatry Associates Clinical Studies Unit|
756261|NCT00322153|The recruitment period was from May 20, 2005 to April 18th, 2007 at 83 study centers in four countries (23 in Argentina, 11 in Chile, 11 in Mexico, and 38 in the US)|Study consisted of 1-2 weeks single-blind placebo treatment followed by 24 weeks double-blind treatment. At the end of single-blind placebo treatment, patients meeting entry criteria were randomized (1:1) to 1 of 2 double-blind treatment groups receiving memantine or placebo.
756262|NCT00322101|Patients were recruited from medical clinics while being evaluated for stem cell transplantation|
756263|NCT00322049|51 infants enrolled and vaccinated for safety cohort, all received dose 1 and 50 completed the study. 49 vaccinated for ATP immunogenicity cohort.|
756264|NCT00322023|Nathan Kline Institute, Yale University, Zucker Hillside|
756265|NCT00321984|Subjects enrolled at 154 sites in the United States (US); date of first dose: 08 June 2006; date of last procedure: 11 December 2006.|Subjects with endoscopically documented normal esophageal mucosa were enrolled in Dexlansoprazole Modified Release (MR) or Placebo once daily (QD) treatment group; subjects were instructed that lifestyle or behavioral modifications designed to treat their symptoms of gastroesophageal reflux disease (GERD) should not be altered throughout the study.
756266|NCT00321971|The University of Pittsburgh ADRC patient registry was searched for all cases diagnosed with MCI in the 6 months before the start of data collection and new cases of MCI or early dementia (any type) diagnosed at the ADRC during the subsequent 46-month time frame. Participants had to live with the person with MCI or early dementia|
756267|NCT00321932|Patients undergoing allogeneic hematopoietic stem cell transplantation (HCT) at participating institutions were offered this trial. If the patient met study requirements, the patient was registered and randomized.|
756268|NCT00321919|This study was conducted from 26 July 2000 to 13 December 2004 at 94 centers in 21 countries.|Of the 605 participants, 603 started the study; 2 were withdrawn from the study due to non-compliance with good clinical practice and were excluded from the analysis.
756269|NCT00321906||
756270|NCT00321893|Recruitment Period: April 2006 to July 2007. Participants were recruited in Milan, Italy at the European Institute of Oncology.|Of 225 participants registered, 23 participants were excluded from the trial before assignment to groups.
756271|NCT00321854||
756272|NCT00321828||
756273|NCT00321789||
756274|NCT00321763||
756275|NCT00321737|Subjects were enrolled at a total of 94 sites: 75 sites in the United States and 19 sites in Australia, Canada, the Czech Republic, Estonia, India, Latvia, Lithuania, Poland, and the Slovak Republic (date of first dose: 19 May 2006; date of last procedure: 21 May 2007).|Subjects had to have endoscopically proven healed erosive esophagitis (EE) after 4 to 8 weeks of treatment with lansoprazole 30 mg once-daily (QD), dexlansoprazole modified release (MR) 60 mg QD, or dexlansoprazole MR 90 mg QD in the EE healing studies, T-EE04-084 (NCT00251693) and T-EE04-085 (NCT00251719).
756276|NCT00321711|Participants in Part A were enrolled from 9 November 2006 through 31 August 2007; participants in Part B were enrolled from 26 March 2008 through 3 November 2008. Participants who enrolled in Part A were not eligible for enrollment in Part B.|
756277|NCT00321698|Subject accrual from Urology clinics started in April 2006; annual follow-up of 22 VA, 3 Oregon Health & Science University (OHSU) (25 total) subjects who completed ended in 2011; 10 year follow-up of these patients will be completed in 2021.|Our 1 screen failure was excluded as a result of having a different type of cancer, other than non-melanoma skin cancer, within the past 5 years.
756278|NCT00321685|This study was activated on July 25, 2006 and terminated on May 26, 2010 with a final accrual of 57 patients from 11 participating sites.|
756279|NCT00321672||
756280|NCT00321646|42 subjects were consented, screened, registered and enrolled between 7/27/06 and 3/24/09 in the relevant clinics at Duke University (5 subjects) and DF/HCC (37 subjects).|No subjects were found to be ineligible after signing the informed consent form and registering with the QACT.
756281|NCT00321620|Participants were enrolled from 12 May 2006 through 18 December 2008.|1904 participants were enrolled, however 3 were excluded from all analyses as Institutional Review Board review activities and oversight were not ensured.
756282|NCT00321594||
756283|NCT00321555||
756284|NCT00321464|Participants were enrolled from 27 April 2006 through 31 December 2007|2049 patients were enrolled in the study, but 3 patients were excluded from all analyses because properly documented informed consent was not obtained.
756285|NCT00321373|A total of 1220 subjects were enrolled in the study. Study duration was of approximately 6 months (180 days) for all subjects.|
756286|NCT00321321|May 2006 - March 2007, Outpatient clinic and advertisement|
756287|NCT00321269||
756288|NCT00321048||
756289|NCT00320801|07-Jan-2004 (First subject first visit); 09-Mar-2005 (last subject last visit of extension [subjects went directly into the extension upon completion of the double-blind phase]) at 42 sites in the United States (US).|Adult subjects (≥ 40 years), with osteoarthritis (OA) of the hip, knee or spine for longer than 1 year, controlled on oral opioid therapy, who met the inclusion/exclusion criteria specified in the protocol. The open-label run-in period (N = 188) selected subjects who tolerated BTDS 20 mcg/h and showed stable pain control (N = 96 completed).
756290|NCT00320788|The study was conducted at 29 study sites in the United States. Recruitment period: May 2006 to April 2007.|A total of 301 participants were screened; 159 participants were randomized; 157 participants were included in both the Safety Analysis Set (SAF) and the Full Analysis Set (FAS) as all received study treatment, had baseline assessments and at least 1 post-baseline assessment.
756291|NCT00320749|Patients were enrolled into the study between December 2005 and February 2008.|Patients had histologically or cytologically confirmed metastatic pancreatic adenocarcinoma and measurable disease per RECIST criteria.
756292|NCT00320710|The initial study design contained 3 arms: zoledronic acid q4 weeks, zoledronic acid q12 weeks and placebo q4 weeks. Due to a study amendment, the placebo arm was discontinued and participants in this treatment group were switched to the zoledronic acid q4 week group. These participants were not included in the efficacy analysis.|
756293|NCT00320671||
756294|NCT00320606|Three centers in the United States enrolled 20 pediatric recipients of parental living-donor liver allografts between June 2006 and August 2008.|Informed consent was obtained from eligible individuals prior to screening assessments. Participants then underwent procedures at screening to determine eligibility according to the study's inclusion/exclusion criteria.
756297|NCT00320528||Study Period I was a 3-day screening period. Study Period II was 12 weeks long. Study Period III was an optional additional 12 week open-label extension. Results are presented for Period II (patients who received at least one dose of study drug).
756298|NCT00320515||This was a Phase 1/2 trial. There were 16 participants in Phase 1. None of them qualified for the Phase 2 portion of the trial. There were 73 participants in Phase 2; however, 4 were excluded from all analyses due to data quality issues at one site. Results presented here are for the 69 participants in Phase 2.
756299|NCT00320489||
756300|NCT00320424|Total of 48 participants undergoing major orthopedic surgery of the lower limb such as hip fracture surgery, knee replacement surgery and hip replacement surgery were enrolled from 16 February 2006 to 26 October 2006 at 9 centers in Japan. The safety population consisted of 48 participants and full analysis set consisted of 37 participants.|
756301|NCT00320411||
756302|NCT00320398|A total of 115 participants who had undergone total Hip replacement surgery were randomized to the study. The study was conducted from 30 January 2006 to 18 July 2006 at eight centers in Japan. A total of 114 and 94 participants were included in Safety and Full analysis set population respectively.|
756303|NCT00320385||
756304|NCT00320372|The TRD Registry was to enroll over a maximum period of 6 years & patients were to be followed for at least 60 months. All sites were to first recruit patients who had agreed to have adjunctive VNS Therapy. Sites were also asked to enroll patients with TRD who would not be implanted with VNS Therapy and would act as a concurrent control group.|A total of 878 subjects were screened in the TRD Registry Study. Thirty-seven were not eligible and 46 were eligible but not treated for various reasons. This left a total of 795 patients in the Safety Population (SP).
756305|NCT00320281|Participants that met eligibility criteria were enrolled from April 2006 through August 2008. All participants were enrolled while undergoing inpatient rehabilitation at Craig Hospital. 19 individuals were enrolled and randomized into the study.|
756306|NCT00320255||A total of 130 participants were enrolled and randomized; however, 1 withdrew consent and 2 no longer met study criteria. Therefore, 127 participants were treated. Reasons Not Completed listed in the data table below were summarized for 127 participants who received treatment.
756307|NCT00320242|All subjects were recruited by movement disorders specialists seen during their clinic visits at either of the 2 participating hospitals|6 of the original 32 subjects who had agreed to participate in the study dropped out before any exposure to the laserlight visual cue. Therefore, data are presented only for the 26 subjects who actually participated in the study, includign exposure to this laserlight visual cue.
756308|NCT00320216|320 participants from 45 sites in North America were randomized to receive either Ustekinumab or placebo.|
756309|NCT00320190||Of 52 participants enrolled, 32 were randomized to treatment. Of the 20 not randomized, 17 no longer met study criteria, 1 participant had an adverse event prior to randomization, 1 participant was enrolled after the sponsor stopped recruitment, and 1 participant was stopped due to administrative reasons.
756310|NCT00320112||
756311|NCT00319982|Participants were recruited from the HCM clinics at Brigham and Women's Hospital (Boston, MA), Boston Children's Hospital (Boston, MA), and Royal Prince Alfred Hospital (Sydney, Australia). Participants were recruited from 2006 through 2010.|
756312|NCT00319956|The study recruitment started 9/04 ended 8/08. All subjects were enrolled after admission to NICU. Randomized treatment started within 12 hrs of beginning ventilatory support. If outborn, consent was obtained from parent(s) after phone discussion by the research staff. The consents were faxed, witnessed and brought back by the Transport Team.|
756313|NCT00319839|Study start date: March 2006 Primary completion date: May 2009 Study completion date: June 2010|
756314|NCT00319748||15 patients were originally consented to enter the study; however 1 patient died before participating in study and 1 patient made the decision to withdraw before being treated.
756315|NCT00319735||
756316|NCT00319696|Patients were enrolled at 33 centers in 7 countries (Canada, France, Germany, Italy, Switzerland, UK, and USA. The first patient enrolled and started treatment on 8 July 2004 and the last patient enrolled and started treatment on 20 October 2005.|Patients who completed RAPIDS-2 and who still had digital ulcers (DUs) or developed a new digital ulcer (DU) after the last follow-up visit were eligible. After release of the RAPIDS-2 results, patients who were prematurely discontinued from RAPIDS-2 for treatment failure or, if on placebo, for an adverse event and had DUs were also eligible.
756317|NCT00319644|Study was a randomized, controlled trial of adult patients admitted to the trauma/surgical intensive care unit of San Francisco General Hospital and was conducted from 5/1/2005 to August 15, 2008|Adult patients with suspected VAP were randomized to the mini-BAL (MB) diagnostic group or the tracheal aspirate (TA) diagnostic group.
756318|NCT00319592|Participants were enrolled from 18 May 2005 to 07 September 2005 at 1clinical center in the United States.|A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
756319|NCT00319553|Participants were enrolled from 09 May 2006 to 02 October 2006 in 12 clinical centers in the US.|A total of 647 participants who met the inclusion and exclusion criteria were enrolled, 644 were vaccinated and included in the analysis.
756320|NCT00319501||Of 234 participants randomized, 71 (29 placebo, 42 diazepam) did not receive/attempt to receive treatment. Discontinuation prior to treatment due to: 3,0 protocol violations; 6,5 sponsor's request; 4,8 Principal Investigator request; 5,11 other; 0,2 lost to follow-up, and 9,10 withdrawn consent.
756321|NCT00319449||
756322|NCT00319436|All mothers enrolled in outpatient substance use treatment and caring for a child between birth and 36 months of age were eligible. Mothers were recruited via clinician referrals and self-referral. Mothers who were actively suicidal, homicidal, severely cognitively impaired, disengaged from their treatment or not fluent in English were excluded.|Mothers were informed that after completing a baseline assessment they would be randomly assigned to one of two parenting programs. Mothers were asked permission to access their clinic attendance records and urinary toxicity results over the course of the study.
756323|NCT00319254||
756354|NCT00316706||Subjects from the Cervarix group continued the long-term follow-up study until Month 48 while subjects from the Havrix group completed the study at Month 24.
756355|NCT00316693||Six subjects enrolled in this study were not vaccinated and hence not reported as started in the participant flow table below.
756356|NCT00316602||
756324|NCT00319111|Patients were enrolled at 26 centers in 13 countries (Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, The Netherlands, Poland, Spain, UK, and USA. The first patient started treatment on 26 January 2006 and the last patient received their last dose of study treatment on 23 February 2009.|In total, 148 of the patients who received randomized treatment in BENEFIT (NCT00313222) rolled over into the BENEFIT OL extension. In addition, 3 patients on bosentan who were prematurely discontinued from BENEFIT (NCT00313222) were also included in the analysis, providing a total of 151 patients
756325|NCT00319098||Out of the 5075 subjects enrolled in this study, 4 subjects did not receive any study vaccine and were hence excluded from study start.
756326|NCT00319046|Patients were enrolled at 16 centers in 10 countries (Australia, Brazil, Canada, Czech Republic, France, Netherlands , Spain, Taiwan, UK, and USA. The first patient, first visit was 21 February 2006 and the last patient, last visit was 22 June 2010.|
756327|NCT00319020|36 Children ( >= 2 years and < 12 years) with idiopathic or familial pulmonary arterial hypertension were recruited from 11 centers across Europe and USA and enrolled in the FUTURE 1 trial (baseline). Only patients who completed FUTURE 1 (n=34) could be enrolled in FUTURE 2. Enrollment in FUTURE 2 started August 23, 2005.|The actual number of patients enrolled in FUTURE 2 (F-2) was 33 because 2 patients did not complete FUTURE 1 (F-1) and one patient completed F-1 but was not enrolled in F-2.
756328|NCT00318929|Recruitment began April 2006 and completed January 2008. Subjects were seen in an outpatient clinic|Subjects recruited had either inadequately controlled seizures or were taking Depakote twice a day.
756329|NCT00318812|May 2007 - February 2011, 55 Chronic Kidney Disease patients >18years,with an estimated Glomerular Filtration Rate (eGFR) <30mls/minute and Hemoglobin (Hgb) of 90-110 were recruited. Recruitment was expanded to eGFR ≤60 and Hgb of 90-120g/L (females)and 90-135 g/L (males) with serum ferritin < 100 mcg /L or Transferrin Saturation (TSAT) < 20%)|15 of the 55 patients were screen failures due to; Hgb too high/low, ferritin level too high, Vitamin B level too low,one had bypass surgery
756330|NCT00318708||
756331|NCT00318656||
756332|NCT00318591||
756333|NCT00318565|First subject enrollment on June 7, 2006 Last subject enrolled August 14, 2007. Enrollment rate was 20.5 subjects per month across 21 hospitals|
756334|NCT00318474|184 subjects were enrolled. 146 subjects completed entry evaluation. 97 subjects fulfilled entry criteria and were started on 3 month course of Omacor and lisinopril. 94 subjects completed the 3 months of treatment.|After the 3 months, 58 subjects fulfilled criteria for going into the MMF vs. placebo phase. Six of the 58 subjects were not randomized because the External Advisory Committee/Data Safety Monitoring Board recommended stopping the trial because of lack of effect.
756335|NCT00318461|A total of 170 centres in 21 countries: Argentina (4), Australia (19), Belgium (6), Bulgaria (1), Germany (33), Denmark (9), Spain (14), United Kingdom (11), Croatia (2), Hungary (5), Ireland (4), India (5), Italy (10), The Netherlands (5), New Zealand (3), Norway (8), Romania (3), Russia (6), Sweden (8), Slovakia (7) and South Africa (7)|Eligible subjects discontinued their oral anti-diabetic drug treatment and commenced a 3-week period of forced titration of metformin followed by a 3-week maintenance period. Subjects on current metformin therapy could go through a modified titration period or advance directly to the 3-week maintenance period at the discretion of the investigator.
756336|NCT00318409|Participants were actively recruited at the municipal STD and HIV clinics, and by street outreach. Recruitment flyers were posted at locations of active recruitment, in local newspapers and in print media and on social networking websites.|After informed consent, participants were screened in two screening visits, with lab and HIV testing, medical history and physical exam, and urine meth testing.
756337|NCT00318370|The first 6 participants enrolled in this study were dosed at farletuzumab, 37.5 mg/m2. The next 6 participants were dosed at farletuzumab, 62.5 mg/m2. The remaining participants received farletuzumab, 100 mg/m2.|
756338|NCT00318357|Patient alive from original CARE-HF study consented for long term follow-up|
756339|NCT00318292|Patients undergoing vaginal hysterectomy with McCall culdoplasty at the Mayo Clinic Hospital were recruited from 17 May 2006 to 14 February 2008. We screened 146 patients who were scheduled for vaginal surgery, and 142 were eligible to participate.|95 of the eligible patients consented to participate. 3 were excluded prior to treatment because they converted to abdominal hysterectomy. 2 were excluded because the study treatment was unintentionally missed by the operating staff.
756340|NCT00318149||
756341|NCT00318136||
756342|NCT00317941||
756343|NCT00317720|This is a a pooled analysis, stemming from two Phase I/II trials that occurred concurrently under separate investigational new drug applications (INDs) at The University of Texas MD Anderson Cancer Center (MDACC; IND 69277); and Beth Israel Deaconess Medical Center (BIDMC, IND 76179) with Dana-Farber Cancer Institute (DFCI), May 2006 to May 2009.|Results data for the two aforementioned BIDMC/DFCI and MDACC trials were combined in order to statistically complete the clinical trials. There were forty participants registered at MDACC, and eleven participants registered at BIDMC/DFCI. Of the eleven participants recruited at BIDMC/DFCI, four were ineligible.
756344|NCT00317642||352 patients screened and 326 randomized, 163 to each treatment group. One participant withdrew after being randomized to the Placebo and Cytarabine Group and was excluded from efficacy analysis.
756345|NCT00317473|Subject were randomized in a 2:1 ratio between the FMP1/AS02A and Imovax vaccine groups.|
756346|NCT00317239|Hospitals and medical clinics|
756347|NCT00317226|Hospitals and medical clinics|no treatment with FCM in the trial excluded 18 subjects from the Safety population
756348|NCT00317109||
756349|NCT00317044||Four randomized patients were excluded from the ITT analysis due to missing efficacy data (2 patients), no investigational product given (1 patient), and being unblinded by the investigator (1 patient). The patient who received no investigational product was excluded from the safety analysis and is not included in the Baseline Characteristics.
756350|NCT00316914|One-hundred and four (104) participants were recruited between January 2006 and June 2007 from 20 North Central Cancer Treatment Group (NCCTG) member sites.|Two participants in Calcium/Magnesium arm canceled prior to study medication begins. These two participants were excluded from all analysis.
756351|NCT00316888|This study was activated on January 19, 2007, 28 patients were enrolled to arm I (closed to accrual on 11/3/2008) and 35 patients were enrolled to arm II (open to accrual on 8/18/2009).|
756357|NCT00316589||
756358|NCT00316524||
756360|NCT00316303|Patients with co-occuring mental illness and substance use disorders who were receiving services from 2 publicly funded community mental health programs in Baltimore, MD.|
756361|NCT00316277|653 treatment-seeking outpatients dependent on prescription opioids across 10 U.S. sites.|
756362|NCT00316264|It was anticipated that approximately 240 children (80 in each group) would be enrolled from the southern hemisphere during the upcoming RSV season (2006).|Children were randomized into one of three regimens in a 1:1:1 ratio; the first group received 2 doses of motavizumab followed by 3 doses of palivizumab; the second group received 2 doses of palivizumab followed by 3 doses of motavizumab; and the third group received 5 doses of motavizumab.
756363|NCT00316225||
756364|NCT00316199||
756365|NCT00316186||
756366|NCT00316173||The run-in phase was conducted to find a safe dose of drug, before the treatment phase of the study began. Different doses were given to 22 participants (enrolled a few at a time) to find the safest dose. Once the safe dose was found, 55 new participants were enrolled in the treatment phase, and all were to start their treatment at this safe dose.
756367|NCT00316121|Subjects were enrolled from 3Apr06 to 31Dec07. Subjects were seen at medical clinics/hospitals, usually by their regular doctor and not found through ads. Subjects were asked to enroll if they were having back surgery for back pain. Enrollment was stopped for administrative reasons at 138 subjects; the per protocol plan was at least 350 subjects.|220 subjects were screened and 82 were excluded (59 did not meet criteria and 23 refused participation).Use of non-steroidal anti-inflammatory medications or cyclooxygenase-II (COX-2) inhibitors (a non-steroidal anti-inflammatory drug that directly targets COX-2, an enzyme responsible for inflammation and pain) at time of surgery were exclusionary.
756368|NCT00316082||
756369|NCT00316017|Subjects were enrolled by Emergency Medicine Services (EMS) personnel in the pre-hospital setting based on pre-defined inclusion/exclusion criteria. The first subject was enrolled on May 9, 2006 and the last subject was enrolled on August 25, 2008.|895 subjects were randomized. 852 subjects completed the study. Randomization was performed when the outer study fluid bag wrapper was removed in the presence of a patient. To ensure there was no bias, a secondary intention to treat analysis was also performed which included all randomized patients even if the fluid was not administered.
756370|NCT00316004|Subjects were enrolled by Emergency Medicine Services (EMS) personnel in the prehospital setting based on pre-defined inclusion/exclusion criteria. The first subject was enrolled in May 2006. The last subject was enrolled in May 2009.|1331 subjects were randomized. 1282 were included in primary imputation analysis. 49 were randomized with study fluid package opened but no study fluid was given. Reasons given were: Did not meet inclusion criteria; Met an exclusion criterion; No intravenous access; Fluid bag sterility broken; EMS responder unsure of inclusion/exclusion criteria.
756371|NCT00315939|A total of 120 adults with type 1 diabetes were recruited through regional advertising. Inclusion criteria were age ≥18 years, type 1 diabetes defined by the American Diabetes Association criteria or physician judgment, and willingness to participate in the study for up to 12 months performing finger sticks four to five times per day.|
756372|NCT00315822||
756373|NCT00315731||Blood pharmacokinetics (the primary objective), biodistribution, and organ dosimetry following a dosimetric dose of tositumomab and fission-derived iodine I-131 tositumomab in this study were compared with results following a dosimetric dose of tositumomab and tellurium-derived iodine I-131 tositumomab in a historical control group (NCT00996996).
756374|NCT00315705||
756375|NCT00315627||
756376|NCT00315614||
756377|NCT00315588||
756378|NCT00315458|12-Dec-2003 (First Patient First Visit) 02-Mar-2005 (Last Patient Last Visit of Extension). At the time of early termination, 39 centers had screened subjects, 22 centers had randomized subjects to the double-blind phase.|All subjects (N = 159) in the run-in period received BTDS 5 for the first 3 days, titrated to BTDS 10 or 20, continued stable nonopioid analgesic regimen for osteoarthritis (OA) pain, and took oxycodone immediate-release 5-mg capsules as supplemental analgesic therapy for primary OA pain site. N = 107 completed the run-in and were randomized.
756379|NCT00315445|10-Dec-1997 (first subject, first visit) to 08-May-1998 (last subject last visit) in 13 centers in the United States|This study was designed to evaluate the efficacy and safety of BTDS in comparison with current pharmacotherapeutic pain management practice and placebo in opioid-naïve or opioid-experienced adult subjects with chronic back pain not manageable with nonopioid analgesics alone (range, 19-85 years).
756380|NCT00315341|Methadone clinics in California, Oregon, Washington, Pennsylvania, New York, and Connecticut|
756381|NCT00315328|Between August 2005 and July 2007, 233 subjects were randomized at 39 certified sites (193 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 40 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).|Subjects must have been wearing optimal spectacle correction for a minimum of 16 weeks or until stability of visual acuity was documented (no improvement in amblyopic eye visual acuity at 2 consecutive visits at least 4 weeks apart) before enrollment and randomization.
756382|NCT00315302|Between Feb 2005 and May 2007, 240 subjects were randomized at 30 sites (180 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 60 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).|Subjects must have had stable visual acuity in glasses (if applicable) before enrollment and randomization.
756383|NCT00315146|Starting in April 2006,144 participants underwent a medical screening. After further exclusion (n = 47) and declining to participate (n = 9), 88 participants (48 men, 40 women) were randomized to one of the four treatment groups.|
756384|NCT00315120|A total of 455 participants were recruited from the Dallas-Fort Worth, Texas metroplex from August 2006 to September 2010 through newspaper advertisements, community agencies, and medical clinics, excluding OMT specialty clinics.|Participants were randomized after their study eligibility was confirmed by both telephonic and clinical screening examinations.
756385|NCT00315055|Participants were enrolled and treated from 01 June 2006 to 18 June 2007 in 1 clinical center in Turkey.|A total of 310 participants who met the inclusion but non of the exclusion criteria were enrolled and vaccinated.
756386|NCT00314951|Subjects were enrolled from May 2006 to August 2008 by centers in the United States and Canada.|
756387|NCT00314808|Patients were accrued between May 2006 and June 2009 within the clinic at Duke Comprehensive Cancer Center.|
756388|NCT00314795|Participants took part in the study at 5 investigative sites in Europe from 06-Apr-2006 to 31-Oct-2016.|Participants with a diagnosis of chronic renal failure (CRF) with confirmed antibody-mediated pure red cell aplasia (PRCA) were enrolled to receive peginesatide subcutaneous injection up to 0.3 mg/kg, once every 4 weeks for up to 60 months.
756389|NCT00314574||
756390|NCT00314366|Twenty one patients were recruited between 9/1/06 and 8/6/08 from outpatient Cardiology clinics.|
756391|NCT00314353||
756392|NCT00314340|Participants were recruited from the UC Davis Medical Center Pain and VA Northern California Pain Clinics in 2007-8. They had to have had chronic pain for more than 3 months and to have self-escalated their dose of a short-acting opioid (i.e., a combination product containing hydrocodone, codeine, or oxycodone)prescribed to treat their pain.|Of 55 patients approached, 18 were evaluated, and 14 met entry criteria and were enrolled. Two withdrew before starting the study. One subject withdrew after starting the study because of insufficient pain relief from the study medications leaving 35 visits by 12 patients for analysis.
756393|NCT00314327||
756394|NCT00314262|Between October 24, 2006, and June 28, 2012, 36 subjects with documented premalignant lesions, including mild (mild-D), moderate, or severe oral leukoplakia, and carcinoma in situ (CIS) were screened. Lesion sites included oral cavity oropharynx, and the larynx.|Seventeen subjects were enrolled on the study, 3 of whom withdrew consent (one male of 69 years of age, and two females of 43 and 42 years of age). Two patients who signed informed consent were deemed to be screen failures, one secondary to prior history of oral squamous cell carcinoma and the other secondary to a history of cardiac arrhythmias.
756395|NCT00314249|Recruitment period was from 4/28/06 through 12/27/07 with last patient last visit on 6/30/08 at 65 centers in the US and 3 centers in Canada|Upon completion of the washout period, a two-week baseline period was completed prior to randomization. Patients were then randomized in a 1:1 ratio to either placebo or milnacipran 100 mg/day (50 mg BID [twice a day])
756396|NCT00314236|Subjects were recruited from May 04, 2006 to January 2009 from orthopaedic surgeon referrals across 24 centers across Canada, Europe, and South Korea.|Subjects were stratified by site and lesion type (acute/chronic) to address possible repair differences. Final eligibility and lesion type were determined during diagnostic arthroscopy at treatment visit, subjects were randomized to BST-CarGel or MFX treatment using a computer-generated randomization schedule to ensure a 1:1 ratio within each site.
756397|NCT00314145|Participants were enrolled and treated from 07 November 2005 to 15 November 2006 at 5 clinical centers in Australia and 5 clinical centers in the US.|A total of 820 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
756398|NCT00314132|Participants were enrolled and vaccinated from 10 October 2005 to 30 March 2006 at 6 clinical centers in Australia and 16 clinical centers in the US.|A total of 2004 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
756399|NCT00314106||
756400|NCT00314093||Enrollment reflects the anticipated enrollment. Actual enrollment is unknown due to no longer having access to the data as records were destroyed.
756401|NCT00313911|Participants were enrolled and treated from 17 July 2006 to 02 January 2008 in 1 clinical center in Mexico and 1 clinical center in Peru.|A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
756402|NCT00313846|"25-Apr-2003 (first patient first visit) to 01-Jun-2004 (last patient last visit).
~This study was conducted at 41 medical/research sites in the United States."|529 subjects began the run-in period with buprenorphine transdermal system (BTDS) 5 and their dose was titrated to BTDS 10 or 20 to achieve effective pain control. Subjects meeting criteria for adequate analgesia within 21 days were randomized into the double-blind phase (the number of subjects [N] = 328 completed run-in period).
756403|NCT00313820||Two-week screening and washout phase prior to randomization.
756404|NCT00313781||
756405|NCT00313729||
756406|NCT00313716||
756407|NCT00313703|We enrolled adult patients who presented to one urban emergency department (ED) with a chief complaint of headache.Patients were assigned a headache diagnosis based on criteria established by the International Headache Society (These are available at http://217.174.249.183/upload/CT_Clas/ICHD-IIR1final.pdf)|477 patients underwent a detailed interview in the ED. 309 of these patients were determined to have a primary headache disorder (a benign recurrent headache disease) and were entered into the post-ED follow-up portion of this cohort study.
756408|NCT00313612|A total of 39 patients were enrolled from 3 institutions between January 2006 and October 2009|1 patient never received treatment
756409|NCT00313586|Participants were recruited from ECOG member institutions between August 18, 2006 and April 29, 2011. One hundred and fifty non-treatment-induced patients and forty-seven treatment-induced patients were enrolled.|
756410|NCT00313560|All patients enrolled at Johns Hopkins|
756411|NCT00313443|Recruitment at a teaching hospital, from July 2006 to October 2007.|67 consecutive patients were evaluated and 30 patients included. Reasons for non inclusion were: impossible to retrace history of amiodarone administration: 19 patients; less than 3 months on amiodarone treatment: 10 patients; unable to give informed consent: 4 patients; refused to participate: 4 patients.
756412|NCT00313313||
756413|NCT00313300||1741 enrolled; 1715 randomized. Non-randomization reasons: 6 withdrew consent, 1 death, 1 poor/non-compliance, 18 no longer met study criteria. Phase A: placebo and 2 low doses of apixaban; Phase B: placebo, 2 low doses and 2 high doses of apixaban. High dose arms terminated, Phase B continued to enroll participants into placebo and low dose arms.
756414|NCT00313209||
756415|NCT00313170|Postmenopausal women with oestrogen receptor positive advanced breast cancer progressing or relapsing after previous endocrine therapy were randomised between 30th May 2006 and 30th November 2007|
756416|NCT00313144|This was a surveillance study conducted by Coram, Inc., in locations throughout the United States, and supervised by Baxter. Enrollment began in June 2006 and the study was terminated early, in December 2008, due to Aralast being phased out of the market.|127 participants enrolled in the study, of these 126 participated in the health related quality of life (HRQoL) and healthcare resource utilization (HCRU) portion, 61 consented to the blood draw portion, and 66 only consented to the Quality of Life portion
756509|NCT00306592||Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
756417|NCT00313014|The study began with first patient first visit (FPFV) on 25-Feb-2004 to last patient last visit (LPLV) on 23-Sep-2005, at 75 medical/research sites in the United States.|Prerandomization: screening period [Prospective assessment: subjects were assessed to ensure compliance with all inclusion/exclusion criteria]. Opioid taper segment: assessed the severity of the subject's low back pain upon analgesic medication discontinuation. Open-label run-in period: identified subjects whose pain was controlled with BTDS 20.
756418|NCT00312923|The study was conducted between April, 2006 and July, 2009 at three inner-city outpatient HIV/AIDS clinics located in a Chicago neighborhood that has been designated as medically underserved by the Health Resources Service Administration (HRSA).|A total of 176 participants were screened for eligibility and 54 were randomized and entered into the intent-to-treat analyses. Most of the ineligible participants did not meet the study's lipid criteria
756419|NCT00312897|Recruitment began in December 2005, with enrollment from January 2006 to June 2013|57 were consented, 6 did not meet eligibility and were not randomized. 3 participants enrolled in Omega-3 Fatty Acids arm but discontinued prior to receiving treatment and not included in analysis.
756420|NCT00312884||
756421|NCT00312858|"39 clinical sites in the United States
~Date first participant visit: 14-Apr-2006
~Date last participant visit: 25-Mar-2008"|
756422|NCT00312845||
756423|NCT00312728|Approximately 110 subjects were to be enrolled at approximately 40 sites to obtain 100 bevacizumab-treated evaluable subjects. Study started 28 NOV 2005 and completed 5 JUN 2009.|This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated CNS metastases.
756424|NCT00312702|18 immunized, 12 IC's from high dose group and 6 control subject|18 subjects were randomly assigned to the immunization phase for each of the 2 vaccine formulations. 12 IC's from high does group and 1 non immunized infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.
756425|NCT00312663|18 immunized subjects|18 subjects were randomly assigned to the immunization phase for each of the 2 vaccine formulations.
756426|NCT00312572|Study dates: 26-Jun-2003 (first patient first visit) to 21-Jul-2004 (last patient last visit) in 29 medical/research centers in the United States.|"N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily average pain over the last 24 hours score of 0=none or 1=mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in."
756427|NCT00312494||
756428|NCT00312377|First patient enrolled 08 May 2006, last patient enrolled 14 March 2008, cut off date 22 August 2008|
756429|NCT00312338|Study recruitment started in June 2006 and ran until January 29 2008. The study sites included three sites (AZ, CA and IL)|No specific pre-assignment activities.
756430|NCT00312221|Study Dates: 02-Apr-2004 (first subject first visit) to 18 Jul-2005 (last subject last visit); 15-Jun-2005 (first site notified of study termination). The study took place in 82 medical/research sites in the US; 59 sites randomized at least 1 subject.|Men and women aged 40 years or older with OA of the hip, knee, or spine, on 30 to 80 mg/day morphine sulfate (MSO4) or equivalent, with or without nonopioid analgesic medication. (652 subjects entered the run-in period; 418 completed.) Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
756431|NCT00312208||
756432|NCT00312195|(First patient first visit) 19-Mar-2001 to (last patient last visit) 22-Jul-2001 at 42 centers: 21 in the UK and 21 in the US.|The Run-in period (N = 588 subjects started) consisted of titration from buprenorphine transdermal patch (BTDS) 5 to BTDS 10, or 20 mcg/h for tolerability. If BTDS was not tolerated or pain increased, the subject was discontinued. N = 267 subjects were randomized.
756433|NCT00311766|First Patient In:22 February 2006; Last Patient In: 6 July 2010 Locations: Medical Centers|No wash out or run-in periods in this study
756434|NCT00311623||
756435|NCT00311584||
756436|NCT00311402|Patient recruitment initiated from June 2006 and completed in December 2007.|
756437|NCT00311376||
756438|NCT00311363||There were 27 participants who completed the Single-blind Treatment Period who either elected not to enroll into the Double-blind Treatment Period or were considered non-responders and were not randomized.
756439|NCT00311311||
756440|NCT00311246||
756441|NCT00311181||
756442|NCT00311155|The trial was conducted between April 2006 and April 2008 in 9 European countries at 58 investigational sites. The countries participating were: Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Switzerland, and United Kingdom.|
756443|NCT00310856|Subjects were enrolled at three sites in Canada.|All enrolled subjects were included in the study.
756444|NCT00310817|Subjects were enrolled at one center in Finland and in two centers in Poland.|All enrolled subjects were included in the trial.
756445|NCT00310804|1200 subjects were enrolled from 2 sites in Lithuania. Of the 1200 subjects enrolled, 700 (58%) were randomized in site 1 and 500 (42%) in site 2. Baseline characteristics, outcome measures, and adverse event summary are based on retrospective analysis which excluded data from site 2.|All participants enrolled were included in the trial.
756446|NCT00310791||
756447|NCT00310466|First patient first visit: 13 June 2005|
756448|NCT00310440||
756449|NCT00310427||66 subjects were initially screened for the study by undergoing a baseline alcohol cue reactivity test. Eight subjects were assessed as non-reactive and excluded from the study. In addition, 2 subjects refused to participate, and 3 subjects were excluded for other reasons. Thus, 53 subjects were randomized to the two treatment arms.
756450|NCT00310401||
756451|NCT00310388|This was a multi-center, open-label, long-term, safety, tolerability and efficacy study involving 57 study sites in 13 countries (Australia, Belgium, France, Germany, Hungary, Israel, Poland, Russia, South Africa, Spain, Ukraine, the United Kingdom and the United States).|A total of 376 adult epilepsy participants with partial-onset seizures who completed the parent study (VRX-RET-E22-302 [NCT00235755]) entered this open label extension (OLE) study.
756510|NCT00306527|Subjects were enrolled from 5 study centers in Poland.|All subjects enrolled were included in the trial.
756511|NCT00306488||
756452|NCT00310375|Eligible Participants (Par) who completed the Maintenance and Transition Phases of the parent study were enrolled in this open-label extension study. Par received 600-1200 mg/day retigabine as an adjunct therapy to current antiepileptic medication or vagal nerve stimulation until Par was withdrawn or withdrew consent or until study was terminated.|All participants who completed Study VRX-RET-E22-301(parent study) and did not have an ongoing serious adverse event (SAE) were eligible to participate in the study.
756453|NCT00310362||
756454|NCT00310310|Participants were recruited and screened from the Pulmonary Sleep/CPAP Clinic at the Veterans Affairs San Diego Healthcare System (VASDHS). Project offices were based at the VASDHS HSR&D unit.|
756455|NCT00310180|This study was activated on April 7, 2006 and closed to registrations on October 6, 2010. A total of 11,232 patients were preregistered for Recurrence Score evaluation and 10,273 proceeded to register on the study.|Patients needed to be preregistered to the trial for ONCOTYPE recurrence score test, patients then were assigned or randomized to one of the four arms based on the recurrence score.
756456|NCT00310076||
756457|NCT00310050||
756458|NCT00310037|From June 2006 to June 2010, 151 participants were enrolled at 14 sites and 147 participants received protocol treatment.|Of the 147 participants who began treatment, 102 participants were randomized. Participants who were not randomized are excluded from all analyses per study design.
756459|NCT00309985|This study was activated on July 28, 2006 and closed to accrual on November 21, 2012, after accrual of 790 patients.|
756460|NCT00309959|This trial was opened to patient entry on November 6, 2006 and was closed to accrual on February 1, 2011.|
756461|NCT00309946||
756462|NCT00309907||
756463|NCT00309842||
756464|NCT00309777|Subjects were randomized to one of 4 treatment arms based on inclusion/exclusion criteria.|After a 6-8 week run in period when no lipid lowering therapy was allowed, subjects were randomized to one of 4 treatment arms.
756465|NCT00309751||
756466|NCT00309738|Subjects were enrolled from September 2005 to October 2006 at 43 investigator sites.|Patients who qualified entered a 6-8 week wash-out/dietary lead-in period followed by a 12- week treatment period. Patients were randomly assigned to one of the two treatment groups: pitavastatin 4 mg QD, or simvastatin 40 mg QD in a ratio of 2:1.
756467|NCT00309608||
756468|NCT00309465|Recruitment at William Beaumont Heath System Royal Oak and Troy campuses commenced in October 2005 and was completed in September 2008.|Subjects were stratified into groups (insulin glargine only group and insulin glargine plus bolus group) by the absence or presence of daily rapid-acting (or short-acting) insulin in regimen. The two groups were then randomized into Take 80%, Call Physician or Dose Table strategies. One subject was excluded from analysis due to eligibility error.
756469|NCT00309452||There were 512 requests for information, of which 491 were screened by phone for eligibility. 284 were excluded. Of the 207 who completed a full in-person eligibility assessment, 2 were deemed ineligible and 29 were provided STEP care without randomization in an initial pilot (data not included). 120 of the remaining 176 patients were enrolled.
756470|NCT00309387|1020 participants were enrolled from January 8, 1996 through April 10, 1998 at the Institute of Ophthalmology of the University of Parma, Parma, Italy|Potential participants had to complete a 1-month placebo run-in period (use of > 75% of the run-in tablets) before randomization
756471|NCT00309244|First subject enrolled Feb. 23, 2006 Multi-national trial conducted in US, Canada, Mexico, Brazil, Argentina, Chile, Spain, UK, Poland, Russia|"3 week Screening period prior to randomization - 2064 Screened / 673 Eligible . 677 subjects were randomized. ( 4 ineligible subjects were randomized in error) 1391 screen failures.
~23 Subjects randomized but never dosed."
756472|NCT00309166||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
756473|NCT00309140||Eligible participants must have completed other enzastaurin clinical pharmacology studies to meet the enrollment criteria for the study.
756474|NCT00308997||
756475|NCT00308737|First subject enrolled July 25, 2005 Multi-national trial conducted in Canada, Czech Republic, Poland, Russia, Spain, Ukraine, UK, and US|"Subjects were required to meet all inclusion/exclusion criteria 3741 screened/2053 eligible of which all were randomized, including 164 non-diabetics - 1688 screen failures
~17 diabetics randomized but not dosed
~1 non-diabetic elected not to participate"
756476|NCT00308711|First subject entered 26 April 2006; last subject completed 07 August 2007; 49 hospitals entered subjects requiring cervical ripening prior to induction of labor.|
756477|NCT00308620|2006-2008 recruitment of volunteers in HIV care but electing to not receive ART.|
756478|NCT00308581||Of the 539 subjects that have been enrolled in the induction phase, 373 have been included in the randomized maintenance phase. The Baseline Characteristics module only includes the Intent-to-treat (ITTI) population of the induction phase.
756479|NCT00308555|315 participants were screened, via phone and e-mail, between January 2007 and February 2009. 24 subjects were enrolled, 13 taking morphine and 11 taking oxycodone.|
756480|NCT00308516||
756481|NCT00308308|First Patient enrolled Feb, 2006 Multi-national trial conducted in US, Canada, Mexico, Brazil, Argentina, Chile, Spain, UK, Poland, Russia|3 week Screening Period prior to randomization - 1420 Screened / 598 Eligible of which 589 were randomized - 822 screen failures 24 Subjects randomized but never dosed
756482|NCT00308282|Study populations are based on randomized treatment groups. Safety and Pharmacokinetic (PK) populations were adjusted due to dosing errors and account for actual treatment received.|Completers were defined as having completed 3 infusions and required follow-up visits.
756483|NCT00308230|medical specialty clinic|"No washout or run-in period. Participants were stable Ambulatory outpatients with no changes in their medical regimen for prior to enrollment.
~Exclusions included inability to complete a six minute walk, inability to cooperate with instructions, congenital diagnosis other than the three listed in the CHD group (TOF, DTGA, CCTGA)"
756484|NCT00308139||
756485|NCT00308113|Recruitment started in April 2007 at two participating centers of the Cooperative International Neuromuscular Research Group (CINRG): University of Pittsburgh and University of Puerto Rico. Enrollment closed in December 2008 by the CINRG Data and Safety Monitoring Board (DSMB) due to changes in standard of care.|
756650|NCT00297037||
756486|NCT00308087|One hundred ninety-six (196) patients were planned and 44 centers were open for enrollment. Eighty-two (82) patients were screened from 22 investigator sites across the United States and Puerto Rico.|82 patients screened
756487|NCT00308074|Recruitment will take place from mainly the Cambridge Health Alliance clinics, and the McLean Hospital affiliated service site for children and adolescents with an autism spectrum disorder (ASD), but also from other healthcare facilities in the vicinity.|All individuals enrolled will have Diagnostic and Statistical Manual Fourth Edition (DSM-IV) diagnoses of Autism, Asperger's Disorder or Pervasive Developmental Disorder, not otherwise specified (PDD NOS) and will be enrolled in this 12-week open-label study
756488|NCT00308061|40 subjects were randomized at 1:1 ratio to receive either FMP1/AS02A or Imovax Rabies vaccine. All 40 subjects received all 3 immunizations and were followed for 12 months|
756489|NCT00307931|This study screened 17 subjects in 7 sites in Greece. The first subject was screened in March 2007 and the last subject was screened in February 2008. Of the 17 subjects screened, 16 were included in the Intention-to-treat population, i.e., were enrolled in the study and received at least one dose of study medication.|
756490|NCT00307801|The date of first subject first visit was 16 Feb 2006. The date of last visit last subject was 27 May 2008.|A total of 575 subjects were screened for inclusion into the study. 344 failed screening. The remaining 231 were randomized.
756491|NCT00307736|This is a single center (institutions comprising Dana Farber Partners/Harvard Cancer Center) trial. Subjects were selected upon referral to the respective clinics of the investigators' institution. Patients Patients were enrolled on to the study between May 2006 and December 2009.|
756492|NCT00307684|Subjects were recruited by Psychiatrists both at medical clinics and private practices between 13-Jan-2006 and 14-Nov-2006|Subjects who participated in the 42603ATT3002 study and still met all eligibility criteria could enter open-label (OL) phase of this study. Subjects who had received at least 52 weeks of uninterrupted treatment with PR OROS methylphenidate (MPH) and provided informed consent could enter the double-blind phase (DB).45 subjects consented for DB.
756493|NCT00307489|A total of 106 subjects were randomized (105 of which were subsequently treated) across 28 study centers in the US, Germany, France and Spain between 24 April 2006 and 07 March 2007.|
756494|NCT00307437|In this trial, 1230 participants were randomized to either placebo or ustekinumab (CNTO 1275). There were 70 sites in North America and Europe.|2 participants from placebo group (in controlled period [CP]) after completing the CP did not crossover to the Placebo -> Ustekinumab 90 mg (after CP) treatment group and they are not included in this group (after CP). Thus, 1199 participants completed the 1st period (CP); however, only 1197 participants started the 2nd period (after CP).
756495|NCT00307333||
756496|NCT00307294||
756497|NCT00307164|Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between October 5, 2006 (date first subject was randomized) and January 7, 2008 (date last subject was randomized).|A total of 167 subjects were randomized, and results are reported for 165 eligible participants; two subjects never started study medication and were excluded from all analyses. The subjects were stratified by antiretroviral therapy use, stavudine (d4T) or zidovudine (AZT/ZDV).
756498|NCT00307151|Study participants were recruited at 10 study sites, 4 in South Africa and 1 each in Uganda, Zimbabwe, Zambia, Malawi, Tanzania and India between November 9, 2006 and March 19, 2010.|Infants and children 6 - 36 months of age (lower age limit changed to 2 months in Protocol Version 4.0) were stratified by age (2-<6 months, 6-<12 months and >=12 months) and randomly assigned to receive either AZT/3TC/NVP or AZT/3TC/LPV/r. One subject was randomized but never started study treatment.
756499|NCT00307125|N=757 subjects were enrolled in the screening phase (Stage 1: Screening) of the study and followed for development of de novo anti-HLA antibodies for up to 60 months post-kidney (renal) transplant.N=22 subjects from the screening cohort were enrolled in the treatment phase. Refer to Detailed Description and Eligibility Sections for more details.|From the screening cohort, N=22 subjects were enrolled in the treatment phase of the study (Stage 2: Pilot Study). Refer to Detailed Description and Eligibility Sections for more details.
756500|NCT00307086|Participants recruited from the Blood and Marrow Transplant (BMT) program at H. Lee Moffitt Cancer Center.|
756501|NCT00307047|Subjects enrolled into this trial were comprised of male and female subjects from the general interventional cardiology population. Recruitment may have, but was not limited to a hospital or an interventional cardiology clinic. The enrollment period was August 10, 2006 through July 30, 2008.|Patients who met inclusion/exclusion criteria were offered participation in the study, and randomized until the total trial population was reached.
756502|NCT00307034||
756503|NCT00306995||After Part I, the core study (study period from Visit 1 on Day 0 up to the phone contact on Day 51), the enrolled subjects were stratified into Subset 1 (Part II - Visit 5 on Day 189 to study conclusion, i.e ., Visit 7 on Day 365) or Subset 2 (Part II - Visit 6 on Day 365 to study conclusion, i.e ., phone contact on Day 395).
756504|NCT00306917|Recruitment began in September 2002 and ended June 2006. Study subjects were recruited and enrolled in medical clinics by orthopaedic surgeons at eight investigational sites. Each site could enroll a maximum of 50 subjects. Recruitment was based on the inclusion and exclusion criteria as indicated in the study protocol.|Immediately before surgery, the implant type was determined according to the randomization schedule. Enrolled subjects may have been excluded from the trial before assignment to the study arm based upon results of pre-operative clinical evaluations and radiographs that would exclude a subject based on exclusion criteria in the study protocol.
756505|NCT00306891|This was a two part study.Part A had two arms, fed/fasted and fasted/fed. Part B had two arms, a fixed dose arm and a dose escalation arm.Patients(pts)in Part A were allowed to go in to Part B. Pts who chose not to go in to Part B discontinued the study.Additionally new pts were recruited to Part B. In Parts A/B, there was a total of 60 pts.|"60 patients were enrolled though only 45 patients were randomized to Part A and 47 to Part B.
~Completion of Part B means completed at least 16 weeks of treatment."
756506|NCT00306852||
756507|NCT00306787||A total of 1179 patients were randomized in the study and followed to their first genital herpes recurrence. A total of 423 patients did not experience a recurrence within 4 months of randomization therefore, no treatment was initiated and study drug was not taken. A total of 756 patients were randomized and took study drug (safety population).
756508|NCT00306670||
756512|NCT00306384|Patients who completed 1 of the following 7 studies took part in the study at 423 investigative sites worldwide: SYR-322-PLC-010 (NCT00286455); SYR-322-SULF-007 (NCT00286468); SYR-322-MET-008 (NCT00286442); SYR-322-TZD-009 (NCT00286494); SYR-322-INS-011 (NCT00286429); 01-05-TL-322OPI-001 (NCT00328627); 01-06-TL-322OPI-002 (NCT00395512).|Patients who had previously completed 1 of 7 double-blind alogliptin studies were randomized (1:1) to either 12.5 or 25 mg once daily alogliptin. Patients who were rescued during their previous double-blind study in response to protocol-defined hyperglycemic rescue criteria were assigned to alogliptin 25 mg.
756513|NCT00306293|Seventy participants were enrolled at 14 centers in the United States. The study was conducted between 20 February 2006 and 28 November 2006.|Out of the 70 participants 35 participants were randomized to the VALTREX 1 g First then Placebo treatment sequence (VAL-PBO) and 35 participants were randomized to the Placebo first then VALTREX 1 g treatment sequence (PBO-VAL).
756514|NCT00306202||
756515|NCT00306189||
756516|NCT00306163||A total of 101 subjects gave Informed Consent. 64 subjects did not enter or discontinued the study due to various reasons.
756517|NCT00305942||
756518|NCT00305877|This study was activated on February 17, 2006 and terminated on January 9, 2008 with final accrual of 137 patients.|
756519|NCT00305864||In multicenter clinical trials the accrual closure date must be predicted so that sites can be notified weeks in advance. As expected, this process often results in a final number of patients differing from the planned accrual.
756520|NCT00305773|A total of 37 participants were enrolled into this trial between January 2006 and August 2007. One patient on Arm A was ineligible; this participant was included in all analyses.|
756521|NCT00305760||
756522|NCT00305695|GOG 0215 accrued 160 patients from November 2005 to April 2010.|
756523|NCT00305682|7 patients were excluded from receiving the treatment as they were not eligible. 4 patients were removed from the study because the participating site withdrew the participation from the study|
756524|NCT00305643|Recruitment Period: February 27, 2006 to October 06, 2008 from various medical clinics and institutions representing the Community Clinical Oncology Program (CCOP).|Study terminated due to slow accrual.
756525|NCT00305604|"First Patient In: 30-MAR-2006
~Last Patient Last Visit: 12-MAR-2008
~60 medical clinics in the United States."|Community dwelling patients ≥ 65 years of age with a diagnosis of type 2 diabetes with hemoglobin A1c (HbA1c) ≥ 7% and ≤ 10% on diet and exercise were eligible to participate. Following a variable duration screening period, patients were randomized in a 1:1 ratio to sitagliptin 100 mg q.d. (or 50 mg q.d. based on creatinine clearance) and placebo.
756526|NCT00305578||
756527|NCT00305565||A total of 331 subjects at 29 sites were actually enrolled and implanted with the Vagus Nerve Stimulation (VNS) Therapy System, and were included in the safety dataset. Twenty-one subjects were excluded from the intent-to-treat (ITT) dataset, leaving 310 in the ITT population.
756528|NCT00305448|Postmenopausal women with oestrogen receptor positive advanced breast cancer progressing or relapsing after previousendocrine therapy were randomized between 7th March 2006 and 4th September 2007. The trial was conducted in Japan only. One patient randomised to Fulvestrant 500mg was not dosed, so the Safety population has 46 patients for that arm.|8 of the 151 enrolled patients were not randomized to treatment groups for the following reasons - 8 patients were incorrectly enrolled (ie did not comply with one or more inclusion / exclusion criteria).
756529|NCT00305344|23 total subjects were enrolled.|Patients with autologous cord blood in private storage facilities were eligible. No eligible patients were excluded.
756530|NCT00305253||
756531|NCT00305227|February 2006 ~ February 2009 University of Washington student health center|
756532|NCT00305162|Patients were selected for randomization based on the need for percutaneous coronary intervention (PCI). Randomization could only occur after the need for PCI was confirmed by angiography, with the exception of ST-segment elevation myocardial infarction (STEMI) patients, who could be enrolled upon confirmation of STEMI by electrocardiogram (ECG).|
756533|NCT00305110||
756534|NCT00305084|Study Period: 28 February 2006 (first enrollment); 8 May 2007 (last completed). 3 investigational centres in Italy and 1 in Netherlands.|"Screening details:
~Planned sample size: 20-25 patients; Patients screened n.: 15; Patients screening failure n.: 0."
756535|NCT00305058||
756536|NCT00304954|The study was conducted at the Clinical Center, NIH. A total of 13 participants met the eligibility criteria for the study and were enrolled from September 2006 to May 2008.|
756537|NCT00304915||
756538|NCT00304746|The study was conducted at two sites - McLean Hospital in Belmont Massachusetts, USA and the Chaim Sheba Medical Center in Tel Hashomer, Israel. Using advertisements at each site, we recruited men age 30-65 with major depressive disorder incompletely responsive to a serotonergic antidepressant, and showing a total testosterone level ≤ 350 ng/dL.|At baseline, participants began a 1-week, single-blind placebo lead-in of one packet of placebo gel daily. Men exhibiting ≥ 50% improvement on either the Hamilton Depression Rating Scale (HAM-D) or Montgomery-Asberg Depression Rating Scale (MADRS) after placebo lead-in were withdrawn; all others were randomized to study medication.
756539|NCT00304707||
756540|NCT00304512||Before randomization, participants were stratified into 2 groups (high or low) by their baseline α-galactosidase A (α-Gal A) activity. High was defined as activity greater than 40% of normal; low was defined as activity less than or equal to 40% of normal.
756541|NCT00304356|Chart review at the Houston VA for patients treated with Nitazoxanide who have failed previous therapy.|This is a retrospective chart review.
756542|NCT00304278|Recruitment open between May 2006 and October 2009 at a small academic center outpatient otolaryngology/ oncology clinic.|
756543|NCT00304265|Participants were enrolled from February 2006 to July 2006 at 17 clinical sites in Germany.|A total of 214 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. One over aged participant was also vaccinated and included in the safety analysis.
756544|NCT00304187|Eating Disorders Research Clinic at New York State Psychiatric Institute|
756545|NCT00304161|Patients were recruited from The Parkinson's Disease and Movement Disorders Center at Pennsylvania Hospital and the Parkinson's Disease Research, Education, and Clinical Center at the Philadelphia Veterans Affairs Medical Center between 2004-2009.|
756546|NCT00304096|University of Virginia Dec 13, 2005 to May 6, 2008|12 participants were registered to the study and 11 received vaccines. One participant was not compliant and did not receive vaccine.
756547|NCT00304083||
756548|NCT00304070||
756549|NCT00304031||Sites were required to submit participant tumor tissue for central histologic review and MGMT (O-6-methylguanine-DNA methyltransferase) status determination in order for registered participants to continue on the study. Of 1173 participants initially registered, 1125 participants met these requirements and started protocol treatment.
756550|NCT00303979|The study sites included outpatient cardiology practices in the United States. Patients diagnosed with heart failure or prior myocardial infarction or developed moderate-severe left ventricular dysfunction were included. Each cardiology practice had five chart reviews and an educational workshop as a part of the process improvement intervention.|The study included 3 mutually exclusive patient cohorts. Patients in cohort A were reviewed at baseline, 12 and 24 months. This is also called the longitudinal cohort. Patients in cohort B and C were reviewed at 6 and 18 months, respectively. These two cohorts are referred to as the single time point cohorts.
756551|NCT00303966||
756552|NCT00303953||
756553|NCT00303901||
756554|NCT00303862|Patients were enrolled between December, 2006 and July, 2007 at three institutions. The trial was terminated after 10 patients were enrolled due to insufficent accrual rate.|
756555|NCT00303823||
756556|NCT00303719||
756557|NCT00303667||50 patients were originally enrolled; only 47 patients were treated. 4 patients received a natural killer cell (NK) infusion but did not get a transplant because of an early death.
756558|NCT00303628|The study was activated on February 17, 2006. Due to slow accrual, it was terminated on April 29, 2009 before reaching its accrual goal with final accrual of 355 patients.|
756559|NCT00303602||
756560|NCT00303511|retrospective chart review|
756561|NCT00303485|A total of 67 participants were enrolled across 9 study centers in the United States. This study was conducted between 06 February 2006 and 21 June 2007. Out of 67 participants enrolled, 66 participants received at least 1 dose of trial medication (49 participants received Ibandronate and 17 participants received placebo).|
756562|NCT00303472|First Subject Enrolled: 15-Feb-2006 Last Subject Enrolled: 29-Feb-2008|The study had 3 parts: Part A (4 weeks), Part B (8 weeks), and a treatment extension phase (up to 1 year). Subjects could participate in either Part A or Part B, and then could choose to enter the treatment extension phase. Subjects participating in Part A were not eligible for participation in Part B.
756563|NCT00303459|First subject, first visit was17 May 2006 and last subject, last visit was 05 Dec 2013.|There was a screening period of up to 14 days to assess eligibility. A total of 377 patients were screened.
756564|NCT00303446|57 subjects were evaluated at the National Institutes of Health (NIH) Clinical Center.|7 subjects were excluded on the basis of screening blood test abnormalities. 50 subjects were randomized.
756565|NCT00303329||
756566|NCT00303316|Participants were enrolled from 15 February 2006 to 03 October 2006 at 1 clinical center in Argentina.|A total of 458 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
756567|NCT00303186||
756568|NCT00303108||
756569|NCT00303069|Phase I; First Subject In: 06-Dec-2005; Last Subject Out: 31-Jul-2006. Enrollment occurred at 6 investigative sites in the United States.|Subject was 18 to 55 years old; in good physical health based upon medical history, physical exam, and screening tests; able to understand study procedures and provided written consent; willing and able to complete entire study; and (if female) provided negative urine pregnancy test before vaccination and using an accepted method of birth control.
756570|NCT00302952|Fifteen sites in the United States participated. The first site was activated in August 2006. The first participant was randomized in November 2007 and the last participant was randomized in February 2012.|
756571|NCT00302848||A total of 59510 women were enrolled. Thereof 836 were excluded as they did not sign the informed consent form, were enrolled two or more times, continued their old OC or did not start OC use. In addition 371 used non oral hormonal contraception at study entry. These women were only used for the comparison of baseline risks.
756572|NCT00302731|Double blind single site pilot clinical trial conducted at academic medical center. Participants randomized to one of 4 arms by computer assignment conducted at independent site not enrolling subjects.|If participants were on hormone replacement at enrollment, needed to have 3 month washout period before randomization. Participants were required to be nonsmokers, have intact uterus, and be menopausal. Screening ultrasound of the uterus, bone density, screening metabolic panel, and baseline mammogram were required.
756573|NCT00302718|We enrolled non-physician primary care personnel at the hospitals randomized to the two study arms that tested the effect of practice-level incentives. Only data from physicians were used to assess both physician-level and practice-level performances. This participant enrollment table does not include data on the non-physician participants.|
756574|NCT00302458|Subjects were enrolled from 2005 to 2007 at Massachusetts General Hospital and were recruited using IRB approved postings through web and email.|Based on a comprehensive screening, subjects who did not meet eligibility criteria for the study were excluded. Others withdrew or were lost to follow-up before randomization.
756575|NCT00302328|3 years|
756576|NCT00302211|Due to slow participant enrollment, the study was prematurely terminated, and recruitment was stopped after 67 subjects had been recruited instead of 180 initially planned (37% of the originally-planned sample size)|
756577|NCT00302159||
756578|NCT00302133|Sample drawn from University-based mental health services, community treatment programs and advertisement|"Total telephone screened included 696 inquiries: 517 excluded for not meeting initial screen criteria; 91 excluded for lost to follow-up with continuing screening; 88 enrolled into the study.
~Of the 88 enrolled, 35 excluded for not meeting the inclusion criteria; 35 were lost to follow-up before group assignment."
756579|NCT00302107|Participants were recruited from the Tuscaloosa and Birmingham VA Medical Centers between April 2006 and November 2010.|Prior to randomization, participants signed informed consent, were assessed to have met eligibility criteria including free of psychotropic medications for the previous two weeks (4 weeks for fluoxetine) prior to randomization.
756580|NCT00302081||696 subjects were randomized. 14 subjects never received any study drug and, therefore, were excluded from the Intent to Treat (ITT) population. ITT population consisted of 682 subjects.
756581|NCT00302068|Enrollment began in June 2006 and ended in September 2010. Participants were recruited from physician referrals, community-based screenings, and mass media advertisements.|
756582|NCT00302055||
756583|NCT00302042||
756584|NCT00302003||
756585|NCT00301964||
756586|NCT00301873|Patients were accrued between February 2006 and January 2008 within the clinic at Duke Comprehensive Cancer Center.|
756587|NCT00301834|Subjects recruited from 9/2005 through 9/2010. Patients identified by the Pediatric BMT (Bone Marrow Transplant) Program and consented by study investigators as outpatients in the BMT clinic.|Patients were ineligible if a cord blood was being used for the transplant or if they met any of the other ineligibility criteria in the protocol or did not meet eligibility criteria such as having Fanconi's Anemia.
756588|NCT00301821|For this study 107 patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) were enrolled. Twenty-six (24%) patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment.|
756589|NCT00301808||
756590|NCT00301756||
756591|NCT00301418||
756592|NCT00301366|First-subject-first-dose was 12 June 2006, last-subject-last-visit was 20 March 2007. The study was performed in 10 clinical sites, 8 sites in the United States and 2 sites in the United Kingdom.|
756593|NCT00301262|31 centers in Canada|183 subjects entered the study, and 176 subjects were treated in the Double Blind (DB) phase. One subject completed DB phase and continued into the open-label (OL) phase but had no events of sexual activity and therefore, did not take study drug and was excluded from the number of treated subjects, the safety analysis set, and PP population.
756594|NCT00301080|Opened in 02/2006 (2-arm design with a 4 week treatment period). The 1st patient enrolled in 05/2006; 7 patients enrolled before it was suspended in 04/2007 pending revision (new 3-arm design & 12 week treatment period). Re-opened in 09/2007, but drug manufacturing & funding issues forced it to terminate with no further accrual in 05/2008.|
756595|NCT00301067|The study opened for accrual on January 13, 2005 with an accrual goal of between 19-28 patients. Accrual was suspended on March 22 2007, reopening May 7 2007, suspended again January 4, 2008, reopening February 14 2008 both times for toxicity evaluations. The study closed permanently on October 28, 2011 with 20 patients enrolled on the study.|
756596|NCT00301028|Recruitment Period: January 31, 2005 to September 16, 2011|Of the forty-eight (48) participants registered, forty-seven (47) were eligible to participate in this trial
756597|NCT00300885|This study was conducted at 150 centers across 20 countries, which enrolled and randomized at least one subject. From a total of 1043 subjects who were screened, 926 subjects were randomized between 15 February 2006 and 9 May 2007 in 20 countries.|Of the 926 subjects who were randomized, 922 received at least one dose of study drug. All 926 subjects were included in the ITT population (intent-to-treat; defined as all randomized patients), all but four subjects did receive study drug. They were not included in the safety population.
756598|NCT00300781||
756599|NCT00300755|Patients were recruited in the United States and Canada from May 2006 to February 2008.|Patients were screened for up to four weeks.
756600|NCT00300742|Participants were recruited in Charlottesville and Richmond between September 2006 to February 2007.|
756601|NCT00300677|Healthy male volunteers were recruited by 1 hospital center in the U.S. between March 2007 and August 2008.|
756602|NCT00300495||One patient in the control group was excluded because, after patient was enrolled, patient had mediastinoscopy that showed more advanced disease. Thus, patient did not undergo lung resection. Therefore this patient was excluded from the study.
756603|NCT00300482||Six subjects were randomized but not treated: 1 was lost to follow-up, 1 was randomized but deemed ineligible, 1 was withdrawn at the investigator's discretion, and 3 withdrew consent.
756604|NCT00300469||Four subjects were randomized but never treated: 2 were randomized but were deemed ineligible, 1 had a history of allergic reactions to statins, and 1 was noncompliant and never received study drug.
756605|NCT00300456||Seven subjects were randomized but never treated: 2 were taking a prohibited concomitant medication, 1 did not meet the entry criteria for lipid levels, 1 had an abnormal baseline electrocardiogram, 1 was unable to swallow pills, and 2 withdrew consent.
756606|NCT00300430||1895 subjects were treated in this study. 306 others who did not enroll in this study but were treated with combo therapy in preceding double-blind studies are included in analyses of adverse events. Six subjects were enrolled, but never received study drug. An additional 10 subjects from a site that was closed were not included in any analysis.
756607|NCT00300391|This study was pre-maturely terminated and although sincere efforts were made to locate the relevant (and accurate) data for results reporting, limited data could be obtained and are reported in the Results section. Some data were either missing or were conflicting and were therefore, excluded.|7 of 40 enrolled subjects never developed delirium, while 2 of 40 had persistent coma and died without ever opening eyes. Subjects were randomized to groups once the delirium was diagnosed. 31 subjects developed delirium and were eligible to randomized. 1 withdrew before starting/being randomized, as a result, 30 subjects were randomized.
756608|NCT00300365|Subjects were recruited and participated in the study from December 2005 and July 2007. Subjects were recruited from the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center.|4 weeks prior to randomization, subjects titrated to 2.0 g/day of niacin extended release. Subjects who could not tolerate niacin were excluded from the study.
756609|NCT00300274||
756610|NCT00300235||
756611|NCT00299988||
756612|NCT00299975|All constipated patients (aged 18-65) who presented to the Chinese Medicine Clinics of School of Chinese Medicine, Hong Kong Baptist University from October 2006 to May 2007 were refered.|177 patients were screened; of these 80 patients were excluded due to not meeting inclusion criteria (68 cases), refused to participate (6 cases) and lost to follow up (6 cases).
756613|NCT00299741|Patients identified from routine care in oncology clinic|
756651|NCT00296816|152 participants were screened for the study. 20 were screen failures. 132 participants met eligibity criteria and were treated with study medication.|
756614|NCT00299702|The first patient in was on February 28, 2006; last patient out was on January 26, 2009. Enrollment occurred across multiple sites in the United States, Argentina, Chile, and India and patients were enrolled from outpatient psychiatric clinics associated with private medical practices, private clinical trial sites, and academic medical centers.|A Screening Visit (maximum of 14 days) prior to the Treatment Phase. Baseline included psychiatric exam, lab, ECG, and schizophrenia symptom rating scale. Subjects were permitted to remain on previous psychotropic medications (i.e., antipsychotic, antidepressant, mood stabilizer, anxiolytics) up to the first 4 weeks of the Treatment Phase.
756615|NCT00299689||
756616|NCT00299546|A total of 461 participants were enrolled at 86 sites in North America, Europe, Australia and New Zealand.|
756617|NCT00299494|A Open-Label, Phase 1/2 Study of CMC-544 (Inotuzumab Ozogamicin) in Combination With Rituximab in Subjects|Eligible Subjects were Randomly Assigned to Study Treatments
756618|NCT00299416|Patient/& or family was approached by one of the investigators in the Emergency Department in order to obtain informed consent.|Open label pilot trial; Caffeinol Arm
756619|NCT00299221|Pts recruited from April 2004-Aug 2008|Consent often obtained after transplant
756620|NCT00299195||
756621|NCT00299156|Recruitment Period: March 2006 to July 2012. All patients registered at The University of Texas M.D. Anderson Cancer Center.|Sixty-five participants were registered, one participant did not receive study treatment. The study consisted of two parts, Phase 1 and a randomized Phase 2 portion.
756622|NCT00299130|A total of 511 participants were recruited and randomized between 27 Oct 2005 and 15 Nov 2006. Of these, 2 participants were randomized but received no infusions (one violated inclusion criteria and the other was randomized to rituximab 2 x 1.0 gram [g] + methotrexate [MTX] but failed to return). A total of 509 participants were treated.|Of the 509 participants, one participant was randomized first to rituximab 2 x 1.0 g + MTX and then to rituximab 2 x 0.5 g + MTX. No assessments were recorded or medication given after first randomization and all data used in analyses was following the second randomization; hence, participant is included only in rituximab 2 x 0.5 g + MTX arm.
756623|NCT00299104||
756624|NCT00299000|"Global study sites were hospitals.
~First Enrollment: 08MAY2006
~Last Dose: 30APR2009"|
756625|NCT00298896||
756626|NCT00298831|The trial was conducted in 19 trial sites in the United States.|
756627|NCT00298766||
756628|NCT00298740||
756629|NCT00298610|Thirty adult subjects with uncomplicated malaria were recruited from the endemic malarious region of Nyanza province in Kenya came to the New Nyanza Medical Center or sub-location recruitment sites.|
756630|NCT00298558|Recruitment occurred from March 1998 through October 1999 at six metropolitan field centers: University of Alabama at Birmingham, Boston Hebrew Rehabilitation Center for Aged (now Hebrew Senior Life), Indiana University School of Medicine, Johns Hopkins University, Pennsylvania State University, and Wayne State University.|Eligibility and demographics were gathered at telephone screening.Health history, physical status, functional status, mental status, cognitive and function measures were gathered via in-person exams in individual and small-group formats at baseline.Eligible subjects were randomly assigned to one of three interventions or no-contact control group.
756631|NCT00298389||
756632|NCT00298363|Of the 112 participants randomized, 43 were in Taiwan or Singapore, 43 were in Europe (Turkey, Spain, Germany, Greece, Poland, Italy, or France), and 26 were in the US or Canada. The first participant was screened on 04 April 2006, and the last participant was randomized on 03 January 2008. Last participant observation date was 12 April 2011.|196 participants screened; 112 randomized and treated (full analysis set; randomized analysis set). Subjects without adequate decrease in HBV DNA at Week 8 could start open-label FTC/TDF. Subjects with virologic breakthrough or HBV DNA levels > 400 copies/mL at ≥ 24 weeks could have received other therapy that may have included open-label FTC/TDF.
756633|NCT00298272|Participants were enrolled at 17 sites in the United States.|"After 24 weeks, participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule prior to the 48-week SFU."
756634|NCT00298233||
756635|NCT00298155||
756636|NCT00298090|Subjects were recruited from inpatients at a local hospital's Intensive Care Unit (ICU)|
756637|NCT00298038||Participants were to be withdrawn from the study after experiencing a breakthrough overt hepatic encephalopathy (HE) episode.
756638|NCT00297830|Men and women, aged 20 to 70 yr, who had undergone heart or liver transplantation at CUMC were eligible. Of 495 patients transplanted between 3/2006 and 7/2009, 235 were ineligible. 149 patients declined or were not approached. 84 were randomized, 43 to alendronate and 41 to zoledronate. 27 were the reference group since they refused randomization.|Serum creatinine levels above 2.0 mg/dl, or enrollment in another clinical trial
756639|NCT00297778||
756640|NCT00297648|Patients were recruited in sites from Germany, France and Belgium between February 2006 and October 2007. The last patient attended their Week 54 visit in December 2009.|
756641|NCT00297596||
756642|NCT00297492|Participants were recruited using advertisements targeting smokers who wanted to quit smoking gradually. Advertisements were placed in newspapers in two cities in South Carolina and one city in New Mexico.|Enrolled sample size of 750; 4 were excluded because found to be ineligible after enrollment.
756643|NCT00297479|Participants were recruited from the Houston metropolitan area via local print media. All data collected between January 2007 to February 2010.|Out of the 650 participants, 412 were on the formal clinical trial and 238 were registered under the pilot phase which were not included in the formal clinical trial and no data collected for those 238 participants.
756644|NCT00297427||
756645|NCT00297258||
756646|NCT00297232||"Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined final data.
~Note: In the Participant Flow table, 'progressive multifocal leukoencephalopathy' is abbreviated to 'PML'. and John Cunningham virus is abbreviated to 'JCV'."
756647|NCT00297167||Out of 34 participants who were enrolled and treated during open-label dose titration and stabilization period, 1 participant withdrew from the study before randomization to first double-blind intervention period.
756648|NCT00297115||
756649|NCT00297102||
756652|NCT00296725|25 Screened. 4 did not return, 2 withdrew consent. Period 1 started with 17 participants available and eligible to participate in period I were treated with fluoxetine; 2 fluoxetine non-responders, 3 non-remiiters and 3/5 dropouts (n=8) continued to Period 2.|17 participants available and eligible to participate in period I
756653|NCT00296647|Participants were 1346 smokers recruited in 12 Aurora Health Care primary care clinics in eastern Wisconsin from October 2005 through May 2007.|Primary inclusion criteria included (1) 18 years or older; (2) 10 or more cigarettes per day (CPD) for the past 6 months; (3) motivated to quit smoking; and (4) if female, willing to use an acceptable contraception while using the study medication.
756654|NCT00296517||"Pre-treatment period: Paroxetine 40 mg/day was administered for four weeks in subjects treated with marketed paroxetine between doses of 20 and 40 mg/day for four weeks or more prior to tapering pretreatment period.
~Tapering pretreatment period: Paroxetine was tapered down weekly by 10 mg/day in subjects who were progressed to treatment period."
756655|NCT00296504|APV30005 enabled Human Immunodeficiency Virus (HIV)-infected participants who had received a Fosamprenavir (FPV)-containing or other regimen in a number of studies, including APV30001, APV30002, and APV30003, to receive FPV until 31 January 2006 (Interim Analysis) or until commercial supplies of FPV were available locally, whichever was later.|Participants are divided into arms depending on the regimen they received in Studies APV30001, APV30002, and APV30003 or whether they were PI-naïve or PI-experienced at the time they enrolled into other studies. For the final analysis, 111 participants are included who continued in APV30005 after 31 January 2006 until study completion.
756656|NCT00296491||
756657|NCT00296400|797 patients entered the study with moderate proteinuria and hypercholesterolemia and were receiving stable treatment with angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blockers (ARBs) for 3 or more months prior to Visit 1. The study was conducted at 114 participating centers in 11 countries.|237 patients [pts] completed the 8-week lead-in period and were randomized. The most common reasons for discontinuation during the lead in period included incorrect enrollment (466 pts), development of study-specific discontinuation criteria (41 pts), and voluntary discontinuation (29 pts). 189 patients completed the study.
756658|NCT00296374|353 patients entered the study with Type 1 or 2 diabetes and were receiving current treatment with angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blockers (ARBs). The study was conducted at 147 centers in 11 countries.|Patients requiring an adjustment of the ACE inhibitor and/or ARBs after Visit 1 were excluded. All 353 patients were randomized and 276 patients completed the study.
756659|NCT00296335|AMC0201 was an open-label, prospective randomised phase 3 clinical trial conducted at three centres (Asan medical center, Hallym University medical center, and Ulsan university hospital) in Korea. Patients were enrolled between February 2002 and August 2006|All enrolled patients received study treatments
756660|NCT00296322||Although this study was originally designed to include 528 patients, a total 521 patients could be enrolled.
756661|NCT00296296||
756662|NCT00296244|Between February 2006 and November 2007,at Thomas Jefferson University, 40 adult orthotopic liver transplantation recipients were enrolled in the study and 20 recipients were randomized in each group.|One recipient in the Steroid free group required re-transplantation and died within 1 month after the 2nd OLT, and was subsequently excluded from analysis.
756663|NCT00296231||
756664|NCT00296192||Participants flow shows all subjects randomized. Safety analyses are based on actual treatment received; 4 subjects randomized to placebo were mistreated (1 subject each in the rotigotine 1 puff, rotigotine 2 puffs, rotigotine 3 puffs, and rotigotine 4 puffs treatment arms).
756665|NCT00296140||
756666|NCT00296036||This trial was originally designed as a two-by-two factorial trial to test if urea/lactic acid-based cream and/or oral pyridoxine (B6) could decrease capecitabine-caused HFS. After results from another study found B6 and capecitabine combination ineffective in preventing HFS, the study was amended to a two-arm, randomized clinical trial.
756667|NCT00295932||
756668|NCT00295880|Patients are recruited from within the Department of Blood and Marrow Transplant Program. (Patients will be co-enrolled on study MT2005-10 (NCT00309842). Eligibility for this study are identical to MT2005-10.)|
756669|NCT00295867|Patients were enrolled between October 2004 and October 2007. Patients were recruited in a medical clinic at the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center.|
756670|NCT00295854|Patients were screened for study eligibility within 7-9 days of randomization. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments prior to randomization at Visit 2 (Baseline Visit, Day 0).|Eligible patients were randomized in a 1:1:1 ratio to receive 500 mg MN-001 twice daily (BID), 500 mg MN-001 once daily (QD), or placebo. Patients returned to the study center at Visit 3 (Day 28) and at Visit 4 (Week 8, Day 64) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3.
756671|NCT00295750||
756672|NCT00295633||
756673|NCT00295620|The first patient was randomized Feb 26, 2004, the last patient was randomized June 30, 2010. Randomization took place in 75 Austrian clinical sites. In total, 3,484 patients were enrolled.|Fourteen patients did not sign the Informed Consent, resulting in 3,470 patients who started the trial.
756674|NCT00295503|Patients recruited from investigators clinics|
756675|NCT00295490|Recruited during 2004 to 2007 Recruitment location: From GP clinics and from adverts in the media|Patients attended screening clinic to confirm diagnosis of osteoarthritis of the knee (grade 2-4) by clinical examination and X ray and ensure other entry criteria met i.e.baseline pain (at least 20mm on 100mm scale over 6 of 7 days between screening and baseline)and exclude any other condition causing knee pain.
756676|NCT00295061|First-subject-first-dose was on 22 May 2006, Last-subject-last-visit was on 28 Feb 2007. The trial was performed at 6 clinical sites in the United States.|
756677|NCT00295022||Participant Flow refers to the Randomized Set.
756678|NCT00295009||
756679|NCT00294762|The first patient was treated 28 March 2006 and the analysis database locked 20 March 2009|All enrolled patients were randomly assigned to 1 of 2 treatment groups.
756738|NCT00290693||
756846|NCT00284089||In total, 88 patients were enrolled in the study, 12 in Group A and 76 in Group B. The single dose phase of the study (Group A patients only) was completed prior to initiation of the multiple dose phase (Groups A and B).
756847|NCT00284050||
756680|NCT00294723|A total of 138 centres in two countries: United States of America (USA) (126) and Mexico (12).|Subjects with type 2 diabetes treated with diet/exercise or OAD (Oral Anti-Diabetic Drug) monotherapy for at least 2 months were eligible. One subject randomised to the liraglutide 1.8 mg group was withdrawn from the study prior to dosing due to protocol non compliance, subject was not included in the intent-to-treat (ITT) or safety analysis sets.
756681|NCT00294684||One patient was enrolled but not randomized. Therefore, the overall number enrolled is 141, while the number randomized and starting participant flow is 140.
756682|NCT00294671|Participants were recruited between May 2006 and December 2010 from amyloid centers of excellence in Sweden (Umea), Italy (Pavia), United Kingdom (London), Japan (Matsumoto and Kumamoto), and the United States (New York, Minnesota, and Massachusetts).|All enrolled participants were randomized to treatment groups.
756683|NCT00294658|The first enrollment of two patients started with July 26, 2006 and the last patient was recruited on November 28, 2012. Of the 126 randomized patients, 96 were from centers outside the US and 30 were from US centers.|After informed consent signed, 66 patients were randomized to extended transsternal thymectomy with prednisone treatment and 60 patients were assigned to take prednisone without surgery. Within the 126 subject that started, 15 dropped out before 3 year follow-up.
756684|NCT00294645|Patients were enrolled from May 24, 2004 through March 30, 2007 at cardiology and electrophysiology clinics in the United States.|Of the 980 patients enrolled, 83 were excluded from analysis: incomplete informed consent forms (n=8), devices incompatible with the Medtronic CareLink® Network (n=7), from research centers that closed prior to cleaning data to the extent necessary for inclusion in cohort (n=67), and exited prior to Baseline assessment (n=1).
756685|NCT00294632|Recruitment Period: February 7, 2006 to February 21, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.|There were 112 participants recruited for registration, 58 were screen failures prior to study inclusion
756686|NCT00294554|Men and women with idiopathic Parkinson's disease (PD) and dementia due to PD recruited from outpatient clinics at Johns Hopkins and outreach to the Baltimore-Washington community through the Johns Hopkins Morris K. Udall Parkinson's Disease Research Center. Recruitment period was 2006 to 2008.|Enrolled participants were excluded if screening assessment showed MMSE>10 and Clinical Dementia Rating (CDR) scale score >1, or diagnostic criteria for dementia with Lewy bodies or DSM-IV-TR substance abuse/dependence or major depressive episode, Hamilton Depression Rating Scale score>17, or severe cardiac, vascular or renal disease.
756687|NCT00294515||
756688|NCT00294398|Patients were screened for enrollment at the Children's Hospital of Philadelphia Emergency Department (ED) between 2006 to 2009. Of the 75,000 annual ED visits in the Children's Hospital of Philadelphia ED per year, more than 6,000 of these visit represent patients with acute asthma.|152 participants were enrolled and randomized between 2006 and 2009 in the Children's Hospital of Philadelphia Emergency Department.
756689|NCT00294060|Patients were enrolled in the study from March 2004 through April 2006.|Only patients who received an approved study device were enrolled in the registry.
756690|NCT00294047|Some subjects completed the study at Months 36 and 48 as they did not want to participate to the extensions up to Month 84, but they were included in the safety analysis for these subsequent timepoints.|Enrolment was stratified by (1) age, with the majority of subjects in age strata 26 - 35 years and 36 - 45 years (about 45% each) and about 10% in the age stratum 46+ years, and (2) previous HPV history (in each age stratum, the number of women with a history of HPV infection/treatment was limited to approximately 15%).
756691|NCT00293813||
756692|NCT00293722||
756693|NCT00293709||
756694|NCT00293579|Patients were enrolled to the study from March 2006 to January 2008|
756695|NCT00293540||
756696|NCT00293462|Adult (> 18 years of age) with confirmed histopathological diagnosis of head and neck carcinoma were recruited at the UCSF Radiation Oncology Clinic, the Helen Diller Comprehensive Cancer Center, Saint Francis Medical Center in San Francisco, and Temple University Radiation Oncology Clinic in Philadelphia from May, 2005 to Dec, 2009.|
756697|NCT00293397|20 patients with unresectable hepatocellular carcinoma (HCC) were enrolled at Johns Hopkins Hospital to undergo treatment with drug-eluting beads (DEBs) infused with doxorubicin. The last patient was enrolled in Dec 2007.|
756698|NCT00293384||
756699|NCT00293293|Eligible patients made informed consent and were randomized to chemotherapy alone or chemotherapy with complementary alternative medicine (hypnosis, massage, healing touch). Patients received either intravenous paclitaxel and carboplatin on an every 3 week basis, or a combination of intravenous and intraperitoneal paclitaxel and cisplatin.|Analysis was conducted as intent-to-treat. All randomized patients were included, regardless of number of courses of chemotherapy, CAM therapy or survival. All women in the CAM arm of the trial received all prescribed CAM interventions. No investigational drugs were administered as a part of this protocol.
756700|NCT00293267|Phase 3; First Patient In: Mar 2006; Last Patient Last Visit (LPLV) Week 48: Aug 2007; 61 of 63 sites in Australia, Belgium, Denmark, France, Germany, Italy, Peru, Portugal, Spain, Switzerland, Taiwan, Thailand randomized patients. Extension Study LPLV Week 240: June 2011|Patients failed prior antiretroviral therapy (HIV RNA >1000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase inhibitors and Protease Inhibitors). All patients must have met laboratory criteria.
756701|NCT00293254|"Phase 3; First Patient In: 08-Mar-2006; Last Patient Last Visit (LPLV) for Week 48: 31-Jul-2007; Extension Study LPLV Week 240: May 2011
~53 sites (US, Brazil, Canada, Colombia, Mexico, and Puerto Rico)."|Patients failed prior antiretroviral therapy (HIV RNA >1000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase Inhibitors, and Protease Inhibitors). All patients must have met laboratory criteria.
756702|NCT00293241|Study start February 2006; last patient enrolled in August 2009.|Patients were electronically randomized. 25 patients were excluded from analysis due to double entry (7) or no evidence of Patient Informed Consent Form (PIC) signed (18).
756703|NCT00293215||
756838|NCT00284934||
756839|NCT00284856||Of the 1640 participants enrolled in the study, 621 participants were excluded during screening and not randomized. The remaining 1019 participants were randomized.
756848|NCT00283959||
756849|NCT00283933||
756704|NCT00293059|The date of first participant, first visit was 14 Dec 2005. The date of last participant, last visit was 21 May 2008.|A total of 1077 participants were screened for inclusion into the study; 887 participants failed screening. The remaining 190 participants were randomized; 120 participants were randomized to the estradiol valerate/dienogest group and 70 participants to the placebo group.
756705|NCT00293033|24FEB2006 to 14MAR2007|During the open-label titration period, subjects were treated with Onsolis at escalating doses (200, 400, 600, 800, and 1200 μg) over a period of up to two weeks until subjects identified a dose that produced satisfactory pain relief for at least two episodes.
756706|NCT00293020|The enrollment period was 3/14/06 - 6/13/08. Subjects were recruited from academic & private clinics in the US. Two groups of subjects were eligible for enrollment in this study. Subjects were eligible to enter this study following completion of the placebo-controlled study, FEN-201 or they were enrolled directly into this study.|
756707|NCT00292981|This was a multicenter, open-label extension study enrolling subjects at 15 sites in North America that had participated in study CE1145_3001 (NCT00168103). Enrollment occurred between August 2005 and January 2008.|
756708|NCT00292942|A total of 47 subjects were screened over the 3 dose escalation cohorts of the study. Twenty-six subjects were enrolled and received IV AS at the USUHS, Clinical Pharmacology Unit (CPU), Bethesda, MD|
756709|NCT00292591||
756710|NCT00292461||
756711|NCT00292370||
756712|NCT00292318||
756713|NCT00292227||Within the placebo patch group, subjects were randomized to the sequence of receiving either placebo saline iv solution or moxifloxacin iv solution on Days 32 and 39 in a cross-over design. This treatment was in addition to treatment with the placebo patch. Subjects in the rotigotine patch group received placebo iv solution on Day 32 and Day 39.
756714|NCT00292188||2-week screening period and single-blind washout and placebo run-in phase followed by a 4-week randomized, dose adjustment, double-blind treatment phase
756715|NCT00292162||
756716|NCT00291876|Participant Flow and Baseline Measures are given for each of the follow-up time points- Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246. Note that not all subjects returned and participated in each of the intermediate follow-up time points.|"The Long-Term (LT) Total Cohort included all subjects who returned for the follow-up and who belonged to the Total Cohort in the primary study.
~The Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity included subjects who returned for the follow-up and who were included in the ATP cohort for immunogenicity of the primary study."
756717|NCT00291694||
756718|NCT00291668|This study started to enroll subjects in March 2006 and conluded in November 2007.|Participant Flow refers to the Safety Set, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).
756719|NCT00291655|Participants Flow describes all subjects treated at least once during open-label monotherapy with Levetiracetam.|
756720|NCT00291642|Participant Flow refers to the Randomized Set.|
756721|NCT00291577||First 12 subjects evaluable for pharmacokinetic (PK) analysis had full PK profile on Cycle 1, Day 1 (C1D1) and C2D1.
756722|NCT00291551|12 investigational sites enrolled 39 subjects between January 2005 and October 2006.|
756723|NCT00291343||
756724|NCT00291330|There were 2564 patients enrolled/randomised in this trial but only 2539 started treatment|
756725|NCT00291317|Difficult to recruit because of transportation limitations|
756726|NCT00291226|Subjects were enrolled between March 2006 and May 2008. Potential subjects or their families or providers were informed about the symptoms of the risk syndrome for psychosis through a variety of ongoing community education efforts and were invited to call our research clinic if concerned.|Exclusions: 1) past or current DSM IV criteria for any lifetime psychotic disorder, 2) alcohol or drug abuse or dependence in the past three months, 3) use of antipsychotic medication in the previous three months, 4) change in dosage of any antidepressant, anxiolytic, psychostimulant, or mood stabilizer medication within eight weeks.
756727|NCT00291187|Recruitment took place at 20 US sites. The first subject was screened on February 9th 2006, the first subject enrolled on March 10th, 2006, and the last subject completed on August 21st 2006.|"Prior to treatment assignment, subjects were instructed to start a sleep schedule that required staying in bed and trying to sleep for at least 8 hours per night.
~One subject randomized to VEC-162 50 mg was non-compliant for sleep schedule. Subject was discontinued on Day 1 prior to study drug administration."
756728|NCT00291161||
756729|NCT00291135||
756730|NCT00291018||
756731|NCT00290888|A total of 86 patients were randomized to either ACR-A or ACR|
756732|NCT00290810|Thirteen patients were accrued to the bevacizumab trial between December 2005 and March 2009.|One patient never received protocol treatment due to a high protein:creatinine ratio and high 24-hour urine protein excretion. Accordingly, 12 eligible patients were included in the outcome analysis.
756733|NCT00290771||
756734|NCT00290758|Study opened to accrual January 6, 2006. Study closed to accrual August 27, 2008. Subjects were recruited from the Lynn Sage Comprehensive Breast Center of Northwestern University, through ads on public transportation, through website and flyer distributions.|Potential subjects underwent a 2 week washout period of soy products, vitamins, and daily aspirin prior to a screening random fine need aspiration (rFNA) of the breast(s). Subjects for which 4,000 or more epithelial cells were obtained the first or second rFNA were considered eligible for study participation.
756735|NCT00290745|Patients seeking treatment at the University of California, San Francisco (UCSF) Breast Care Center and Kaiser Permanente for a diagnosis of DCIS were approached by their physicians at their discretion, and if fitting the eligibility criteria were asked to participate in the study.|
756736|NCT00290732|From February 2006 to October 2009, 19 women signed consent, and 17 women were enrolled in the intraductal portion of the study. An addition 3 women receiving standard intravenous PLD were enrolled in a pharmacokinetic contract portion.|Participants were not included after consent if eligibility criteria were not met (eg, lab values, performance status); an additional 2 subjects were consented but not included in the study population.
756737|NCT00290706|The study opened for accrual to phase I on September 26, 2005 with first patient treated April 7 2006.The study was closed on October 17 2007 to phase I and opened to phase II on December 18 2007. The study closed permanently March 9 2011 with a total accrual of 32 patients treated on the study before reaching the total accrual goal.|
756739|NCT00290654|Eligible patients wereinvited to participate in the study by their physician, who explained the details of the trial and obtained informed consent. Patients who met the eligibility criteria and signed the appropriate consent were entered into the study before the MammoSite device was inserted.|A total of 45 subjects were enrolled. Four subjects did not receive accelerated partial breast irradiation because the minimum distance from the skin to the internal radiation device was <5mm and is associated with poor cosmetic results.
756740|NCT00290615|Patients were recruited between October 2005 and June 2007 in the Duke Cancer Center, Duke Oncology Network, and Wake Forest University.|
756741|NCT00290589||
756742|NCT00290537|Recruitment Period: 01/19/2006 through 11/03/2006. All participants recruited at University of Texas (UT) MD Anderson Cancer Center.|
756743|NCT00290498|Patient eligibility:>/16 -</60 years old and untreated Diffuse Large B-cell Lymphoma,stage II >/10cm mass or stage III/IV),Eastern Cooperative Oncology Group 0-2,age-adjusted Integrated Pulmonary Index of .2, and adequate organ function. Excluded:if they were pregnant,breast-feeding,or evidenced central nervous system lymphoma or active infections.|Three participants were screen failures. Eight participants were removed
756744|NCT00290472||One patient never received protocol treatment and was excluded from analysis.
756745|NCT00290433|Recruitment period: September 17, 2003 to May 8, 2009. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the 55 participants registered, two participants were found not to be eligible prior to start of study therefore are excluded from trial details.
756746|NCT00290407||
756747|NCT00290355||
756748|NCT00290342||Of the 458 subjects enrolled in the study, 6 subjects (5 from Infanrix-IPV Group and 1 from Infanrix + IMOVAX Polio Group) were not administered the study vaccine due to consent withdrawal from parents/guardians and received an elimination code.
756749|NCT00290329||
756750|NCT00290290|Patients 18 years or older undergoing clean-contaminated surgery preformed without substantial spillage or unusual contamination were eligible for enrollment. Patients were excluded if they were allergic to chlorhexidine, alcohol, or iodophors, or had infection at or adjacent to operative site, & if there was a perceived inability for a 30 days F/U|There were no significant events prior to group assignment. Enrolled patients were immediately and randomly assigned in a 1:1 ratio to a study arm. To help match the two groups and address potential inter-hospital differences, randomization was stratified by hospital with the use of computer-generated randomization numbers without blocking
756751|NCT00290251||Seventy-two women were screened for eligibility before being randomized to treatment 1. Of these only 42 were eligible to continue in the study.
756752|NCT00290238||
756753|NCT00290199||
756754|NCT00290186||
756755|NCT00290147|22 healthy adult volunteers enrolled to participate at the Naval Medical Research Center site|
756756|NCT00289991||Subjects were stratified at the time of randomization by the following factors: conditioning regimen (myeloablative or non-myeloablative); relatedness of donor (matched/related or mismatched/unrelated).
756757|NCT00289978||
756758|NCT00289913|In Stage I, a total of 620 participants were randomized to receive study vaccinations. However for 3 participants, the Health Insurance Portability and Accountability Act (HIPAA) and/or Informed Consent Form was not signed by the parents in error. Therefore a total of 617 participants were included in Stage I. 654 participants started Stage II.|For this study: Visit 1 was on Day 1 (for Stage I and Stage II). Visit 2 was at Week 4 (Stage I) and Week 2 (Stage II). Visit 3 was at Week 24/Week 28 (Stage I) and Week 24 (Stage II). Visit 4 was at Week 28/Week 32 (Stage I) and Week 26 (Stage II). For safety, participants were followed for 14 days after each vaccination (safety follow-up [F/U]).
756759|NCT00289900||
756760|NCT00289887|"Patients were recruited at 51 sites in the United States.
~Prime Therapy Period: April 2006 to February 2007"|Prior antihypertensive medications were withdrawn/ tapered before patients entered the 4-week placebo run-in period.
756761|NCT00289874|"One hundred three sites in US;
~Prime Therapy: March 2006 to July 2007"|Patients who had unresolved symptoms and signs of an upper respiratory tract infection between Visits 1 and 2, or had evidence of active, clinically significant sinus infection within 1 week of Visit 1 or between Visits 1 and 2, or failed to meet minimum requirement for daytime asthma symptoms and daily β-agonist use were excluded.
756762|NCT00289848|First Patient In: 27-Apr-2006; Last Patient Last Visit: 30-Mar-2007; Twenty-eight medical clinics (9 in China, 9 in India, and 10 in Korea).|Patients not on an antihyperglycemic agent (AHA) or on oral single AHA or low dose dual combination therapy could participate. After an up to 6-week diet/exercise (and wash-off period for patients on AHA), patients with hemoglobin A1C 7.5-11% and fasting plasma glucose 130-280 mg/dL entered a 2-week placebo run-in period prior to randomization.
756763|NCT00289783|Subjects were randomized at the beginning of the primary phase and kept their group assignment during the fourth dose vaccination phase. The study protocol identified 3 different study cohorts : United States (US) Safety and Immunogenicity (Cohort 1), Safety Only (Cohort 2: from all investigation sites), Non-US Safety and Immunogenicity (Cohort 3).|The data for 261 subjects from one study center in the US were not included in the analyses as vaccine accountability could not be fully reconciled (i.e. treatment group assignment for the different subjects could not be verified).
756764|NCT00289770||Subjects who came back at a follow-up, did not necessarily come back at an earlier timepoint. Therefore amount of subjects who completed the previous timepoint does not always correspond with amount of subjects who entered follow-up. As Year 15 has enrolled the most subjects, baseline measures are given for Year 15, to be as complete as possible.
756765|NCT00289757|Participant Flow and Baseline measures are given for the Month 192 (Year 16) time point in order to account for all subjects participating in this long-term follow-up study. Note that not all subjects returned and participated in each of the intermediate follow-up time points.|The Long-Term (LT) Total Cohort included all subjects who returned for the follow-up and who belonged to the Total Cohort in the primary study.The Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity included subjects who returned for the follow-up and who were included in the ATP cohort for immunogenicity of the primary study.
756840|NCT00284739|Hospitalized patients with loculated abscess were enrolled|All patients had undergone percutaneous drainage for abscess and loculation documented by residual fluid surrounding the catheter after initial drainage
756841|NCT00284557||
756842|NCT00284518||
756766|NCT00289744|All subjects enrolled in the primary study (208127/076) were invited to come back for the long-term follow-up visits at Year 6 to 10. The enrollment in the protocol section reflects the amount of subjects who came back at year 6. At follow up timepoints less subjects came back.|25 subjects lost seroprotective concentrations for anti-HBs antibodies at blood sampling time-points Years 6 to 10 and were offered an additional dose of Engerix™-B after Year 10 (additional dose phase). These subjects are presented in separate sub-groups for analysis purposes while as per study protocol, the single experimental group is Twinrix.
756767|NCT00289731||A total of 596 subjects (199 in Twinrix Group, 200 in Engerix-B+Havrix Group and 197 in HB VAX PRO+Vaqta Group) were enrolled and vaccinated in the study.
756768|NCT00289718||
756769|NCT00289653||
756770|NCT00289536|Recruitment was conducted in the United States at 8 study sites.|Participants were screened for a maximum of 30 days. Participants were randomized to a single sequence of the 3 doses of Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM). Before each pharmacokinetic evaluation, at least a 3 day washout period and negative factor VIII inhibitor titer was required.
756771|NCT00289471||
756772|NCT00289458|Recruitment Sept 2005 to 2006, posters in physician offices, senior housing, recreational facilities and advertisements in local newspaper|
756773|NCT00289341||
756774|NCT00289315||
756775|NCT00289289|The first study implant occurred on 13 February 2004 and the last study visit occurred on 10 November 2010|At the 3-month post-implant follow-up visit, all implanted subjects with documented Atrial tachycardia/Atrial fibrillation episode(s) during the 3-month observation period were eligible for randomization. Subjects with no documented Atrial tachycardia/Atrial fibrillation episodes were followed as part of the non-randomized group.
756776|NCT00289276|There were two parts to the FAST study. The first part was called FAST Pivotal and the second part was called FAST Expansion. Subjects were enrolled in the FAST study from November 2003 through September 2007. Subject follow-ups were complete and all subjects were exited by April 2008.|None of the subjects in FAST Pivotal were included in FAST Expansion.
756777|NCT00289211||
756778|NCT00289198|This study was conducted from 07 February 2006 till 23 June 2006 at 40 centers across the globe. A total of 288 participants with perennial allergic rhinitis (PAR) were planned to be enrolled.|Following a 7 to 14 day screening period, participants who met randomisation criteria were randomised to 6 weeks of treatment with fluticasone furoate or placebo nasal spray once daily. A total of 302 participants were randomised, 151 in each of the treatment groups.
756779|NCT00289185|A total of 340 subjects were enrolled for this study. The study comprised 2 phases, a double-blind phase, from Week 0 to Month 9 (2 months after the administration of the last vaccine dose), followed by a single-blind safety phase, from Month 9 to study end at Month 20.|
756780|NCT00289133||
756781|NCT00289120|Recruited patients of Emory University Department of Urology|Normal subjects and calcium oxalate stone-formers were included.
756782|NCT00289107|Between April 2001 and October 2002, 106 subjects were recruited and enrolled at 3 US clinics by orthopaedic surgeons. Each study site could enroll up to 50 subjects (cohorts were re-assigned as necessary to complete enrollment in a timely manner). Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.|Immediately before surgery, the implant type was determined according to the randomization schedule. Before treatment assignment, consented subjects could be excluded from the trial based on results of pre-operative clinical evaluations and/or radiographs, as per the exclusion criteria in the clinical investigation plan.
756783|NCT00289094|Two US clinical centers performed 99 primary knee replacements in 86 subjects. Recruitment was based on the inclusion and exclusion criteria as specified in the clinical investigation plan.|Immediately before surgery, the implant type was determined according to the randomization schedule. Before treatment assignment, consented subjects could be excluded from the trial based on results of pre-operative clinical evaluations and/or radiographs, as per the exclusion criteria in the CIP.
756784|NCT00289016||
756785|NCT00288912|Recruitment began on Oct 3, 2006 and ended on June 30, 2008. We used VA medical records to identify patients with hip and knee OA and no exclusionary diagnoses. We mailed introductory letters to these individuals and followed up with a screening phone call. Eligible patients were asked to come to the Durham VA for a baseline visit.|
756786|NCT00288886|426 Consecutive Graduates Screened for Eligibility, 243 (57%) of those were excluded. [203 (48%) not within a 60-minute drive of aftercare; 15 (4%) no transportation, or aftercare not available due to work schedule; 24 (6%) did not consent; 1 excluded for unknown reason(s)]|
756787|NCT00288860|Veterans entering treatment in five 30-to-90 day residential treatment programs for posttraumatic stress disorder|926 patients were initially consented into the study. 6 withdrew prior to randomization, and 83 met exclusion criteria after being consent (usually because they were discharged to another inpatient program, not to outpatient care). This left 837 subjects to be randomized.
756788|NCT00288704|47 subjects were randomized into Part A. 44 of these subjects continued into the open label extension (OLE). 57 subjects were enrolled directly into the OLE without completing parts A and B of the study. 104 total subjects were in the entire study. 101 were in the OLE.|The study population included male or female adult subjects (Parts A and B), and adult and pediatric subjects (OLE phase), with confirmed NLRP-3 (Cold Induced Autoinflammatory Syndrome-1 or CIAS1) gene mutation. Only one person per household was enrolled into Parts A and B of the study. However, multiple family members went into the OLE.
756789|NCT00288639|Planned to enroll approximately 100 subjects with partial seizures at up to 10 study centers in Greece.|Single arm open label study without randomization. The study included the following 3 main phases with a total study treatment duration of up to 21 weeks: Treatment dose-optimization phase = 9 weeks. Treatment observation phase = 12 weeks.
756790|NCT00288626|36 participants were screened and 25 of those participants were enrolled at 3 sites in the US between August 2006 and August 2009. 24 participants were transplanted with the cellular product between February 2007 and April 2010|
756791|NCT00288600|"Assessed for eligibility 125
~Excluded (n= 33) Not meeting inclusion criteria (n= 26) Declined to participate (n= 4) Other reasons (n= 3)"|
756792|NCT00288587||
756793|NCT00288574||
756843|NCT00284180||
756844|NCT00284154||
756845|NCT00284141|98 participants were registered into the study, of whom, 96 were exposed to study treatment.|
756794|NCT00288509|Patients who completed study NCT00257660 (Y-47-52120-051)were recruited in 15 centres in US and 4 centres in Russia from February 2006 to January 2008 to participate in this study NCT00288509 (Y-47-52120-731).|Of the 116 subjects treated in study NCT00257660, 108 subjects enrolled in this extension study NCT00288509 (Y-47-52120-731). Eight subjects completed study NCT00257660 but elected not to enroll in this extension study.
756795|NCT00288366||
756796|NCT00288080||
756797|NCT00288067||
756798|NCT00288054||
756799|NCT00288015|The study opened for accrual on June 1, 2005 with an accrual goal of up to 31 patients. The study was designed to enroll 12 patients initially and do an interim efficacy assessment. Accrual was suspended on February 28, 2007 for this analysis and reopened on May 15, 2007. Study was closed to accrual permanently on April 19, 2010.|
756800|NCT00287989||
756801|NCT00287872||
756802|NCT00287729||
756803|NCT00287716||
756804|NCT00287690||
756805|NCT00287586||
756806|NCT00287469|2000 subject were recruited by Royal Nepalese Army investigators at the Shree Birendra Hospital, Kathmandu from a well characterized population of Royal Nepalese Army military personnel stationed in the Kathmandu Valley and their family members and up to 5 US citizens residing in the Nepal.|
756807|NCT00287365||None. All subjects who successfully screened were enrolled.
756808|NCT00287339|recruited from hospital clinics - subjects with chronic cough.|. After initial eligibility screening, all consenting participants entered a 7-day run-in period, during which all subjects took a placebo pill twice a day, for the purpose of ensuring compliance with study medication and assessment of cough severity under baseline conditions.
756809|NCT00287287||
756810|NCT00287222|Recruitment Period was from 7/08/2005 to 12/17/2008. Recruitment occurred at the University of Arkansas for Medical Sciences medical oncology clinic and Kansas University Cancer Center.|
756811|NCT00287118||
756812|NCT00287079||
756813|NCT00287053||
756814|NCT00286949|Parkinson's disease (PD) outpatients (recruited 2005-2008 via Johns Hopkins clinics and community) had clinically significant Executive Dysfunction, defined as moderately severe problems with disorganization, distractibility, task completion, planning or problem solving that impaired function, were a decline from pre-PD, and verified by informant.|All enrolled subjects were assigned to and received open label atomoxetine.
756815|NCT00286754||
756816|NCT00286741||
756817|NCT00286728||
756818|NCT00286494|Participants enrolled at 125 investigative sites in 13 countries from 24 February 2006 to 02 August 2007.|Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of 3, once-daily (QD) treatment groups.
756819|NCT00286468|Participants enrolled at 125 investigative sites in Argentina, Australia, Brazil, Chile, Dominican Republic, Germany, Guatemala, India, Mexico, New Zealand, The Netherlands, Poland, South Africa, Spain, and the United States from 04 April 2006 to 20 June 2007.|Participants with a historical diagnosis of type 2 diabetes mellitus who were inadequately controlled while receiving a stable dose of glyburide monotherapy were enrolled in one of 3, once-daily (QD) treatment groups.
756820|NCT00286455|Participants enrolled at 117 investigative sites in 16 countries from 24 February 2006 to 05 July 2007.|Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of 3, once-daily (QD) treatment groups.
756821|NCT00286442|Participants enrolled at 115 investigative sites in Australia, Brazil, Chile, Germany, Guatemala, Hungary, India, Mexico, New Zealand, The Netherlands, Poland, South Africa, Spain, and the United States from 10 March 2006 to 12 June 2007.|Participants with a historical diagnosis of type 2 diabetes mellitus who were inadequately controlled while receiving a stable dose of metformin monotherapy were enrolled in one of 3, once-daily (QD) treatment groups.
756822|NCT00286429|Participants enrolled at 110 investigative sites in Australia, Brazil, Chile, Guatemala, Germany, Hungary, India, Mexico, New Zealand, the Netherlands, Poland, South Africa, and the United States from 16 March 2006 to 18 September 2006|Participants with a historical diagnosis of type 2 diabetes mellitus who were inadequately controlled while being treated with insulin with or without metformin were enrolled in one of three, once-daily (QD) treatment groups.
756823|NCT00286325|Patients with bullous pemphigoid were recruited in dermatology clinics from 2005 - 2009.|Patient were screened for appropriate diagnosis, disease activity, prednisone dosage before entry into the study
756824|NCT00286221||
756825|NCT00286182||
756826|NCT00286156||
756827|NCT00286091|Eligible subjects were men ≥ 18 years old with histologically-confirmed, castrate-resistant prostate cancer who were chemically or surgically castrated. The first patient was enrolled into the study on 03 February 2006 and the last patient was enrolled on 23 July 2008.|Participants were randomized to denosumab or placebo in the double-blind treatment phase. All participants undergoing scheduled assessments were offered open-label denosumab for up to 3 years in the open-label extension phase. Three enrolled patients were excluded from all datasets per ethics committee's instructions due to eligibility violations.
756828|NCT00286078||179 subjects signed consent, 39 subjects screen failed, and 140 eligible subjects were randomized (1 subject was later excluded).
756829|NCT00285857||
756830|NCT00285818||
756831|NCT00285779|This is a randomized, multi-center interventional trial in which patients were recruited at 11 sites in the United States (10 academic and one private practice). Enrollment was between June, 2006 and December, 2008. The first subject was enrolled in August, 2006 and the last patient was enrolled in November, 2008.|
756832|NCT00285649|Participants were recruited primarily through direct mail and local media services.|
756833|NCT00285584|Recruitment: Sept. 2002 - March 2004. High-risk, HIV-seronegative, New York City men who have sex with men (MSM) were informed of the study by field workers at MSM-oriented bars, clubs and community events; advertisements in magazines distributed at such venues; and e-mails to persons offering sexual services for MSM on the Internet.|
756834|NCT00285467||
756835|NCT00285246||
756836|NCT00285207||
756837|NCT00285012||Subjects were current cigarette smokers 35 years of age or older with mild to moderate Chronic Obstructive Pulmonary Disease (COPD) as defined by Global Initiative for Chronic Obstructive Lung Diseases (GOLD) criteria.
756850|NCT00283868|Recruitment completed in 4/07|"There were 11 initial run-in patients used to validate the system but these patients were excluded from the final analysis. There was also 1 patient removed from analysis because of a protocol violation (age < 18) so this patient was excluded rom any analysis (Initial patients=234. 11 Run in=223. 1 removed=222. This accounts for final numbers)"
756851|NCT00283842|Participants were recruited January 2006 to February 2008|Participants were screened during a 7- to 28-day period, a treatment period.
756852|NCT00283816||
756853|NCT00283803|Study enrolled 32 subjects who had developed biochemical progression of prostate cancer, shown by the rising prostate specific antigen level (PSA) after curative therapy (either a radical prostatectomy or external beam irradiation). Trial was open to enrollment 2002 through 2004.|Approximately 40 patients were considered. A total of 32 were accrued between 12Mar2002 and 29Oct2004. Patients not enrolled either failed to meet eligibility criteria or withdrew consent prior to treatment. 19 patients completed study and were evaluable for study endpoints.
756854|NCT00283712|Four study centers in the United States enrolled 20 subjects with pemphigus vulgaris (PV) who met entry criteria between August 2005 and December 2010.|Each participant signed an informed consent before undergoing any screening procedures to assess eligibility. Refer to the Eligibility Section for further details.
756855|NCT00283686|Participants were enrolled at seven clinical sites between February 2006 and June 2009.|
756856|NCT00283595|Subjects were referred from by local eating disorders providers and were recruited from on-line advertisements. Recruitment period: April 2006 through November 2008.|
756857|NCT00283504||
756858|NCT00283439|Participants were enrolled from 15 March 2006 through 28 April 2008|
756859|NCT00283400|The National Institutes of Health funded the Albumin in Subarachnoid Hemorrhage (ALISAH) pilot study, initiated in May 2006 and terminated in May 2010. The study was originally planned for 3 years but mostly due to the principal investigators transferring institutions and initiation of 2 non-US sites, 1 extra year was needed.|
756860|NCT00283387|Subjects were recruited from Mayo Clinic, Rochester between October 2006 and September 2008.|Fifteen subjects were enrolled, but 2 subjects withdrew prior to group assignment.
756861|NCT00283296|All recruitment and data collection occured in 2008 at the Human Engineering Research Laboratories.|
756862|NCT00283283|Study participants were recruited at the Walter Reed Army Medical Center Allergy-Immunization Clinic, the Fort Belvoir DeWitt Allergy-Immunization Clinic and the Pentagon Health Clinic during the annual influenza immunization program.|Enrollment was expanded to include subs with a history of flu vacs. From the originally enrolled subjects (1316), the final data analysis includes only members of the baseline re-vaccination population (1114).
756863|NCT00283244|Subjects were recruited for this study between March 2006 and May 2010|Of the 160 patients who signed informed consent, 13 didn't start treatment for the following reasons: withdrew informed consent (5), referred to hospice (4), ineligible (3), and death before treatment (1). A patient received treatment on trial, but was determined to be ineligible due to incorrect diagnosis, and was thus not included in results.
756864|NCT00283075|Fifty-six subjects provided informed consent to participate in this study; of these 31 subjects underwent the implantation of macrobeads that contain mouse renal adenocarcinoma cells (RENCA macrobeads). The first subject was implanted on 6 April 2005 and the last subject was implanted on 1 November 2011.|
756865|NCT00283062|Originally, the study was planned for 1696 participants to be randomized. However, enrollment was not met and in September 2007, the Steering Committee decided to stop recruitment. Only participants who had signed Informed Consent by then and met eligibility criteria were randomized. 228 participants were randomized to this study.|
756866|NCT00283049||
756867|NCT00282984|The study was conducted in outpatients. The target population was cigarette smokers with cardiovascular disease drawn from the communities surrounding the participating clinics.|714 smokers were randomized (ie, assigned to study treatment), 11 participants were randomized, but not treated. The reasons for participants being randomized, not treated included no longer willing to participate in the study (5 participants), protocol violation (3 participants), lost to follow-up (1 participant), and other (2 participants).
756868|NCT00282971||Total subjects enrolled=354. Total subjects given study drug=351. (ie, 3 subjects withdrew after enrollment/randomization, but prior to receiving study drug)
756869|NCT00282919||
756870|NCT00282867||
756871|NCT00282841||
756872|NCT00282828|Recruitment for this study began in 2006 at the Massachusetts General Hospital, the University of California San Diego, and the Anxiety Disorders Clinic, McMaster University Medical Centre. Through approved recruitment methods, 397 patients with Generalized Social Anxiety Disorder (GSAD) were enrolled in Phase I of the study (open sertraline).|Among the 397 patients enrolled in Phase I of the study, 295 patients entered Phase II. A total of 181 (61%) of the patients who began Phase II were non-responders at week 10 (LSAS>50), and were therefore randomized to receive 12 weeks of treatment in one of three treatment arms (sertraline plus clonazepam, venlafaxine, or sertraline plus placebo).
756873|NCT00282815|Patients enrolled from inpatient neurology service.|
756874|NCT00282672||
756875|NCT00282568|Stable, adult kidney transplant recipients being treated with tacrolimus (Prograf)-based immunosuppressive regimen.|Pharmacokinetic (PK) treatment period was from Day 1 - 35. Participants who completed the PK period were eligible to continue receiving tacrolimus MR in the extended treatment period, from Day 36 up to 60 months.
756876|NCT00282464||7 day washout: psychotropic drugs and lithium. 4 week washout: monoamine oxidase inhibitors. Depot neuroleptic DC'd 6 months before study entry.11 subjects assigned to but not treated with drug: 9 lost to follow up, 1 no longer willing to participate, 1 DC'd due to protocol violation
756877|NCT00282438||
756878|NCT00282412||
756879|NCT00282347||
756880|NCT00282334||
756881|NCT00282308||
756882|NCT00282295||Out of 1344 subjects enrolled, only 1341 were vaccinated.
756883|NCT00282282|Patients with hematologic malignancies who were at high risk of complications after conventional transplantation, with 6/6 HLA matched-related donors were approached with information about participating in the study. Participants were approached at either inpatient or outpatient clinics by physicians between 2006 and 2007.|
756956|NCT00276614|Recruitment period from April 2006 through May 2009 at outpatient oncology clinic.|
756884|NCT00282256|Stable liver transplant recipients aged 12 years or younger receiving tacrolimus based immunosuppression regimen.|Pharmacokinetic (PK) treatment period was 14 days. Participants who completed the PK period were eligible to continue receiving tacrolimus MR in the extended treatment period, from Day 15 through Month 54.
756885|NCT00282243|Stable liver transplant recipients aged 18 to 65 years who were on a stable dose of tacrolimus based immunosuppressive regimen.|Pharmacokinetic (PK) treatment period was 56 days. Participants who completed the PK period were eligible to continue receiving tacrolimus MR in the extended treatment period, from Day 57 up to 60 months.
756886|NCT00282152||7 participants excluded prior to treatment ( 1 withdrew consent and 6 failed screening)
756887|NCT00282113|Premature infants were enrolled from October 2004 to Aug 2006 at the University of California Davis Medical Center Neonatal Intensive Care Unit in Sacramento, California.|
756888|NCT00282087|This was multi-center study open at 11 major medical centers across the United States.|
756889|NCT00282048||
756890|NCT00281957||
756891|NCT00281918||
756892|NCT00281879||
756893|NCT00281840|Patients recruited from University Hospitals (Cleveland OH) and University of Pittsburgh (Pittsburgh PA) from September 2005 through September 2008.|
756894|NCT00281827|Patients were recruited from 3 participating study centers.|
756895|NCT00281697||
756896|NCT00281684|This study was conducted at 3 centers in the United Kingdom, 1 center in Korea, Republic of and 1 center in Italy from 07 December 2005 to 03 October 2007. A total of 145 participants were enrolled into the study.|Participants already scheduled for 3rd molar tooth extraction, who were otherwise healthy, were recruited for this study. As soon as reasonably possible after completion of tooth extraction (but within 1 hour), participants were randomized to treatment and dosed with the study medication whilst local anesthetic was still active.
756897|NCT00281671|"Recruitment: April 2006- June 2007.
~Location: Cardiac ICU in a large children's hospital."|
756898|NCT00281658||At the time of disease progression, participants had the option to be unblinded. Participants (pts) who were on placebo+paclitaxel could continue in an open-label lapatinib monotherapy extension phase until further progression or an unacceptable toxicity. All participants were followed for survival. The unblinding was performed by a third party.
756899|NCT00281632||
756900|NCT00281580||
756901|NCT00281528||
756902|NCT00281463||
756903|NCT00281320||
756904|NCT00281099||2051 subjects were screened for the study. Of the 2051 subjects screened, 1037 were enrolled in the study. 6 of 1037 subjects later failed to meet other qualifying inclusion criteria and were not randomized and assigned to a study arm.
756905|NCT00281021|Patient accrual lasted from March 2006 until August 2008 and was stopped early at the time of interim analysis. 24 who completed at least 6 weeks of therapy are presented here.|
756906|NCT00280917||
756907|NCT00280904||
756908|NCT00280826|"Six participants were enrolled from October 2006 through December 2007.
~Participants were recruited from the National Eye Institute's (NEI) uveitis clinic. In addition, the study was posted on Clinical Trials.gov, the NEI and the Clinical Center's (CC) websites. Self referral and referral from outside physicians was also permitted."|
756909|NCT00280748|Subjects were recruited from 2 institutions between May 2005 and April 2008.|
756910|NCT00280735||Of the 75 participants screened for eligibility, 72 went on to treatment and 3 participants withdrew consent prior to treatment.
756911|NCT00280683|Between 2006-2008, moderate to severe persistent asthma patients, as defined by the NAEPP Expert Panel Reports, were eligible for enrollment [10]. Most subjects were recruited from the UC Davis Asthma Network clinics, which are referral clinics for patients with difficult to control asthma.|The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service.Eligible subjects had documented moderate to severe persistent asthma, were at least 18 years of age, not pregnant, and able to give consent.
756912|NCT00280566|Trial intended to be outpatient trial. Patients hospitalized at the screening visit due to disease under study were to be stable enough for outpatient status within approximately 5 days.|Period 1:open label stabilization (ziprasidone plus lithium or valproic acid mood stabilizer). Period 2:subjects stabilized for 8 weeks randomized to blinded treatment (ziprasidone plus mood stabilizer or placebo plus mood stabilizer). 241 completed Period 1, 238 summarized in Period 2: 1 subject not randomized to Period 2, 2 excluded as per note.
756913|NCT00280397||
756914|NCT00280384||Of the 94 participants screened (60 Japanese, 34 Caucasian), 57 (29 Japanese and 28 Caucasian) participants were admitted to the hospital. 9 (5 Japanese and 4 Caucasian) participants did not receive the study drug. 48 participants received the study drug (24 Japanese and 24 Caucasian) and were considered the treated population.
756915|NCT00280293|112 participants with at least one post-baseline visit were recruited between 2006 and 2010 at our research clinic in Dallas, TX and included for analysis.|Participants with a diagnosis of bipolar I, II or NOS disorders currently depressed or mixed mood with current cocaine dependence and self-reported use within 14 days were included. The study drug was added to existing psychiatric medications or given as monotherapy when participants were not taking other medications at baseline.
756916|NCT00280241||
756917|NCT00280150|Participants were recruited from four institutions between February 2006 and April 2010.|Of the 48 participants screened for eligibility, 46 were deemed eligible and went on to treatment, 1 was ineligible, and 1 was initially ruled eligible but the liver functioning tests (LFTs) continued to increase so the PI felt the participant should not be treated.
756918|NCT00280059||
756919|NCT00279955|1024 subjects were enrolled in the study from 21 JUN 2004 through 14 FEB 2007 from 100 centers in US. Follow-up data collection ended on 06 MAR 2008.|23 of 1024 subjects exited prior to successful implant due to not meeting in/exclusion criteria, unsucessful implants, missing informed consent form etc. Of the remaining 1001 subjects, 643 subjects had been followed longer than 6 months and had the OptiVol feature save-to-disk data available. Those 643 subjects were used for analyzing objectives.
756920|NCT00279916|Study participants were recruited from the patients seen at the Mayo Clinic Department of Otorhinolaryngology (Ears, Nose and Throat) in Rochester, Minnesota. Enrollment occurred from 09/01/2005 through 12/31/2008.|
756921|NCT00279812|Recruitment ran from May until the following February in 2005, 2006, and 2007. Study completed in June 2008. 272 volunteers completed a screening questionnaire,182 volunteers had blood samples screened, total of 133 were recruited and 119 completed the study.|
756922|NCT00279708|Subjects were recruited by national advertising (self-referrals), physician referrals, and through a medical clinic sponsored by the NIH, from March 2006 through March 2015.|Subjects were screened by telephone and later during clinical testing a evaluation at the NIH Clinical Center. During this time subjects were evaluated to determine if they met the enrollment criteria, including that of treatment requiring disease, and relatively stable dosing prior to entry.
756923|NCT00279591|Pediatric interfacility helicopter transport patients between May 2006 and June 2007.|
756924|NCT00279500|Recruitment began in February 2002. The last subject of 6 was enrolled in June 2004.|
756925|NCT00279409||
756926|NCT00279305|Participants with newly diagnosed type 1 diabetes recruited from 12 TrialNet Clinical Centers between|126 patients were assessed; 39 were excluded; 87 underwent randomization (57 were assigned to receive rituximab and 30 were assigned to receive placebo)
756927|NCT00279214||Although 22 and 21 patients were randomized to drotrecogin alfa (activated) [DrotA(a)] and control, respectively, 3 patients in DrotA(a) and 2 patients in control did not receive the per-protocol treatment, and as such, they have been excluded from the baseline demographics and the per-protocol efficacy analyses.
756928|NCT00279201||Initiation: Glargine or Lispro LM - 24 weeks. Maintenance: Up to 2 more years treatment if HbA1c <=7.0 at 24 weeks. After Initiation, if HbA1c >7.0 after 24 weeks, instead of entering Maintenance, those from Lispro LM could receive Basal bolus or Mid Mix; glargine could receive Basal bolus or Lispro LM for 24 weeks in Intensification Addendum.
756929|NCT00278993|This study was recruited at 22 centers in U.S, UK, Spain and Hungary during the period of Feb 2006 to May 2009.|
756930|NCT00278954|First enrollment: 06 February 2006 Last subject completed: 06 November 2007 Seven investigative sites, all hospital clinics|This was an open study. All enrolled subjects received study medication.
756931|NCT00278915||
756932|NCT00278889||
756933|NCT00278876|Forty-eight patients were enrolled at four centers in South Korea between August 2005 and June 2007.|One patient was excluded from the study before treatment initiation because of metastatic disease.
756934|NCT00278863||
756935|NCT00278655|Between January 2003 and February 2005 in Northwestern Memorial Hospital 21 patients with relapsing-remitting multiple sclerosis (MS) underwent autologous hematopoietic stem cell transplantation in order to evaluate the safety and clinical outcome of autologous non-myeloablative hematopoetic stem cell transplantation in MS.|21 eligible patients had relapsing remitting MS not responding to interferon and had had two corticosteroid -treated relapses within the previous 12 months or one relapse and gadolinium-enhancing lesions seen on MRI and separate from the relapse.
756936|NCT00278629||
756937|NCT00278564||
756938|NCT00278538||
756939|NCT00278525|"Eligible (n=19) Randomized (n=19)
~Allocated to Hematopoietic Stem Cell Transplantation (HSCT (n=10) + crossed over to HSCT(n=7)
~• Received HSCT (n=17); Lost to follow-up (n=0); Analysed (n=17)
~Allocated to cyclophosphamide (n=9) • Received allocated intervention (n=9) Lost to follow-up (n=0); Crossed over (n=7); Analysed (n=9)"|
756940|NCT00278512||
756941|NCT00278473|Prospective participants were referred from New York area medical and psychiatric clinics, ADHD advocacy and self-help groups, community psychiatrists and primary care physicians, university health services, and postings on clinical trials web sites.|
756942|NCT00278395|Open to recruitment on 12/5/2005, closed to recruitment on 3/3/09 at The University of Texas Health Science Center San Antonio at Cancer and Therapy Research Center|
756943|NCT00278343||
756944|NCT00278200||"One subject on the EBV seronegative arm was a screen failure. One EBV seronegative subject was not assigned to intervention arm due to physician decision.
~Seven EBV seropositive subjects were not assigned to intervention arm: three due to physician decision; one due to loss of follow-up; one due to death; and two due to subject withdrawal."
756945|NCT00278161||16 participants were screen failures. IRB allowed 3 of those participants to be analyzed along with the 78 who were treated as part of the study. Because the 3 additional participants received the exact same protocol intervention, the total population for analysis purposes is 81.
756946|NCT00278148||9 participants completed the phase I portion of the study. 3 of those subjects continued onto the phase II portion of the study and are included within the 26 participants.
756947|NCT00278109||Two patients did not initiate study procedures: one was found to have residual gross disease during treatment planning, and another withdrew consent.
756948|NCT00277524|The study included 147 outpatient cardiology practices in the United States. Inclusion criteria were(1) implant of an implantable pulse generator (IPG), implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D); and (2) age 18 years or older. Enrollment period was from Aug 2005 to Jun 2006.|This is a post-market prospective study. No group assignment is given. Subjects implanted with IPGs were enrolled and followed at 6 and 12 months. Subjects implanted with ICDs or CRT-Ds were enrolled and followed at six, 12, 24, 36, 48, and 60 months.
756949|NCT00277446|Patients with asthma were recruited from Northwestern's medical clinics and by advertisements in the community.|Patients with asthma were included in the study if they had mild-to-moderate disease not fully controlled on their current treatment.
756950|NCT00277394|Recruitment took place between Dec 2005 and May 2008|2 patients were not randomized
756951|NCT00277355|Between April 2006 and June 2007 , 134 patients were screened and 114 subjects were randomized at 12 Huntington Study Group clinical sites.|20 subjects were excluded from group assignment after screening: 14 failed inclusion criteria and 6 withdrew consent. Minocycline 90 days prior to baseline and open-label during trial not permitted. Other tetracyclines, investigational drugs, lithium, digoxin, methoflurane anesthesia, theophylline and lupus-symptom causing drugs not permitted.
756952|NCT00277212||A total of 1169 patients were enrolled in the study; 382 participants were considered baseline failures and did not enter Phase 1.
756953|NCT00277095||
756954|NCT00276861||
756955|NCT00276744||249 participants were enrolled however 240 received intervention in the study. Reason unknown and data is not accessible for the 9 remaining participants who were not assigned to intervention
756958|NCT00276484|"Phase III
~First Patient In: 4/6/2006; Last Patient Last Visit 2/26/2008
~96 centers worldwide (US, Canada)
~Eligible patients include those on a stable dose of atorvastatin 40 mg; or patients with adjusted LDLC
~pre-screen ranges who were treated with other lipid modifying therapy, or were statin and/or ezetimibe naïve."|"Patients received and were blinded to atorvastatin 40 mg for a 4/5- week run-in period.
~Patients needed an LDL-C ≥ 70 mg/dL and ≤ 160 mg/dL at Visit 2 (week -1). Eligible patients were randomized at Visit 3 (Week 0) to either atorvastatin 80 mg or addition of ezetimibe 10 mg to their 40 mg dose of atorvastatin for a 6-week treatment period."
756959|NCT00276458|"Phase III
~First Patient In: 4/5/2006; Last Patient Last Visit 1/17/2008
~72 centers worldwide (US, Canada, Austria, Costa Rica)
~Eligible patients include those on a stable dose of atorvastatin 20 mg; or patients with adjusted LDL-C pre-screen ranges who were treated with other lipid modifying therapy, or were statin and/or ezetimibe naïve."|"Patients received and were blinded to atorvastatin 20 mg for a 4/5- week run-in period.
~Patients needed an LDL-C ≥ 100 mg/dL and ≤ 160 mg/dL at Visit 2 (week -1). Eligible patients were randomized at Visit 3 (Week 0) to either atorvastatin 40 mg or addition of ezetimibe 10 mg to their 20 mg dose of atorvastatin for a 6-week treatment period."
756960|NCT00276419|25 Participants were recruited at the Mayo Clinic in Rochester Minnesota from June 2005 to May 2009. Seven subjects withdrew after randomization, prior to treatment, 6 in arm A, and 1 in arm B.|
756961|NCT00276406|Participants were recruited from Mayo Clinic in Rochester, Minnesota and the study was conducted at between May 2006 and October 2010.|68 patients were assessed for eligibility. 24 were ineligible. 13 were eligible but declined to participate in the study. One patient consented but was withdrawn because of severe hyperglycemia during the baseline period. 30 were enrolled and completed all study procedures.
756962|NCT00276380|This was a multicentre, international, randomised, double-blind, placebo-controlled study in which 204 subjects were enrolled in 8 centres, distributed in 4 countries: Romania, Poland, Czech Republic and Russian Federation, from 20 February 2003 to 25 February 2009.|The inclusion (baseline) visit on Day 0 was to take place within 3-8 days following an ischaemic stroke.
756963|NCT00276250||Nine subjects signed informed consent. During evaluation, four participants were found ineligible for study inclusion. Five participants completed the evaluation process and were listed for an islet transplant
756964|NCT00276159||
756965|NCT00276094||
756966|NCT00276016||1 subject discontinued for reasons unrelated to treatment with study drug after the first dose (Intervention 1) of study drug Pseudoephedrine(PSE)
756967|NCT00275834|The study was conducted at Duke University Medical Center between 2006 and 2011.|Participants are considered to have completed the study if they returned for final study visit. The number completed represents participants who stayed on study drug during the trial plus participants who discontinued study drug during the trial but continued to be followed by study team and completed the final visit assessments.
756968|NCT00275821||
756969|NCT00275561|Adult patients with a new diagnosis of eosinophilic esophagitis were recruited at the Mayo Clinic Rochester between 10/2005 and 12/2009.|
756970|NCT00275509|A total of 207 participant were assessed for eligibility. Excluded (n=151) Not meeting inclusion criteria (n=115) Declined to participate (n=2) Did not reach transplant prior to end of study (n=34). A total of 56 were randomized.|
756971|NCT00275392||
756972|NCT00275340|Patients (n=106) were recruited between April-February 2007. Patients having elective coronary artery bypass graft surgery were recruited at the outpatient preadmission class; those having urgent/semi-urgent surgery were recruited in hospital. Peers (n=20) were recruited from the region of Southeastern Ontario during February-March 2006.|One hundred and one patients were randomized at hospital discharge to either usual care or peer support. Five patients who were recruited preoperatively did not meet the eligibility criteria postoperatively for randomization. Of the 20 peers recruited, 6 were unable to participate in one of the training sessions offered in April 2006.
756973|NCT00275301|All subjects were symptomatic volunteers from the community.|19 subjects were enrolled. 5 early withdrawals. 14 subjects completed the entire study.
756974|NCT00275275|Patients were enrolled at the University of Kansas Medical Center. Enrollment started in January 2006 and ended in February 2008.|
756975|NCT00275262||
756976|NCT00275028||
756977|NCT00275002|Participants from PBTC member institutions were enrolled between October 2005 and February 2008.|
756978|NCT00274937||No patients were enrolled to Stratum 1.
756979|NCT00274924|Participants were recruited from Eastern Cooperative Oncology Group (ECOG) member institutions between 4/7/2006 and 8/5/2009.|
756980|NCT00274846||
756981|NCT00274781|Patients were enrolled at Cleveland Clinic and the University of Michigan from February 2004 through June 2006.|
756982|NCT00274768|Thirty patients with metastatic breast cancer were consented between August 2005 and December 2008. Twenty six patients were eligible and initiated treatment on-study.|Women (≥ 18 or older) with a histologically confirmed metastatic (stage 4) adenocarcinoma of the breast were eligible. Several inclusion and exclusion applied to confirm that women were appropriate to take part in the study intervention.
756983|NCT00274742|Participants were enrolled from 22 June 2004 through 18 July 2011|"Participants were enrolled into 20 different cohorts representing different dose levels, modes of administration (ramp, single-step, double-step, flat), or populations. To facilitate the analysis of the study, the different cohorts were grouped into six dose groups based on the dose that was intended to be given to a participant."
756984|NCT00274716||Enrolled participants were divided into 2 strata: higher body mass index (BMI) (27 kg/m^2≤BMI<41 kg/m^2) and lower BMI (20 kg/m^2≤BMI<27 kg/m^2) prior to being randomly assigned study treatment. Data from High BMI groups were to be utilized in the primary and secondary analyses; data from low BMI groups were to be utilized in exploratory analyses.
756985|NCT00274651||
756986|NCT00274625||
756987|NCT00274469|Postmenopausal women presenting with advanced breast cancer who had either never received endocrine therapy for advanced disease or had not received endocrine therapy in the previous 12 months in the adjuvant setting were recruited between 6th Feb 2006 and 11th July 2007.|28 of the 233 enrolled patients were not randomized to treatment groups for the following reasons - 20 patients were incorrectly enrolled (ie did not comply with inclusion / exclusion criteria), 1 died, 1 had an adverse event, 4 voluntarily discontinued, 2 patients were not randomized for other non-specified reasons.
756988|NCT00274456||Three hundred and two patients were enrolled and randomized between November 2005 and June 2006, of which 300 received study drug and were evaluated for response and safety. Data below represents data cut-off 31 March 2008.
756989|NCT00274287||
756990|NCT00274261|Female subjects were screened and enrolled at 15 sites in the US.|
756991|NCT00273910|104 subjects were enrolled in this trial.|
756992|NCT00273858||
756993|NCT00273793|Individuals smoking at least 15 cigarettes per day that are at least 18 years old, and deliver a breath CO level greater than or equal to 15 ppm were recruited in a University setting from the general community.|Five weekdaily visits that took about 5 minutes occurred before randomization. 328 individuals consented and of these 239 completed baseline and were randomized. Which set of three study arms individuals were randomly assigned to depended on whether they successfully delivered a C) < 3 ppm during this baseline for which they earned an incentive.
756994|NCT00273754||
756995|NCT00273364||
756996|NCT00273182|The InSync Registry commenced subject enrollment on February 27, 2002. A total of 1999 subjects were enrolled in the study during the time period of February 2002 through February 2008. 1014 subjects completed the study through 36 month follow up. Follow-up of 1000 subjects was required by the FDA to satisfy the conditions of approval.|1999 subjects were enrolled in the study. Of them 1738 had successful post market implants of InSync Model 8040 (n=601), InSync III Model 8042 (n=512) and CRT-D devices (n=625). The rest 262 subjects came from two pre-market studies: MIRACLE study added 141 subjects to InSync Model 8040, InSync III study added 121 to InSync III Model 8042.
756997|NCT00273052||
756998|NCT00272987|Female participants (par.) with histologically confirmed invasive breast cancer (Stage IV disease) whose tumors overexpressed the ErbB2 protein, documented by either Immunohistochemistry (IHC) or fluorescence in situ hybridisation (FISH), were eligible for inclusion in this study.|Participants who met inclusion criteria were sequentially enrolled into three cohorts and received the open-label triple combination of paclitaxel, trastuzumab and lapatinib. The planned randomized phase of the study was terminated following the poor recruitment rate in the Open-label Phase.
756999|NCT00272961||
757000|NCT00272844|Patients newly diagnosed with Smith-Lemli-Opitz syndrome at Boston Children's Hospital were offered enrollment in the study from 1998 until it's completion. The study was completed and closed to enrollment here in June, 2010 and the IND was withdrawn in July, 2011.|
757001|NCT00272792||In Part 1, subjects received Phenoptin for 8 days as part of their evaluation for Phenoptin responsiveness. Subjects who met response criteria were randomized 3:1 to Phenoptin or placebo for additional 10 weeks in Part 2, following a minimum 1-week wash-out period.
757002|NCT00272779||Of 1057 HIV-infected participants, 174 participants were not randomized to receive study drug, the main reason being that they did not meet the study criteria (133/174; 76%). 441 randomized to ATV received any drug and 437 randomized to LPV received any drug. 438 and 440 participants randomized to ATV and LPV, respectively, received correct drug.
757003|NCT00272337|37 subjects were enrolled. Recruitment began in November 2006 and completed in July 2007 in two cardiology office practices directed by Ricky Schneider M.D. and Steven Borzak M.D.|This trial did not include a wash-out or run-in period.
757004|NCT00272311|From Dec 2006 through May 2007, 70 eligible subjects were randomized from a primary care clinical site under the direction of Alex Pokov, MD.|In this trial there was no wash-out or run-in period, as all eligible subjects were not taking aspirin.
757005|NCT00272168||
757006|NCT00272038|Eligible patients were those who met the criteria of Castration Resistant Prostate Cancer (CRPC)who had not yet received chemotherapy.|Patients must have had adquate bone marrow function and, Eastern Cooperative Oncology Group (ECOG) <3, and measurable disease.
757007|NCT00271947|enrolled (n=1)|
757008|NCT00271856|Participants were recruited between July 2005 to August 2008 through newspaper advertisements, electronic bulletin boards, community postings and fliers in clinics.|Enrolled participants were screened to determine if inclusion criteria were met. This process included structured phone interviews, medical history review, and laboratory results.
757009|NCT00271817||
757010|NCT00271739||
757011|NCT00271609|88 participants were accrued to this study.|Minimum washout period of 2-4 weeks required after molecularly targeted or cytotoxic agents.
757012|NCT00271596|Thirty-six individuals were screened and 33 participants were randomized between May 2007 and April 2011 Participants were recruited using advertisements, by speaking at HD events, through local clinics and through two HD registries: The University of Iowa HD registry and the National HD Research Roster (Indiana).|Following the baseline visit, participants completed a study visit (i.e., Visit 01) after 2 weeks in order to wash-out practice effects on primary outcome measures. To further control for practice effects, participants received placebo for 14 days prior to randomization (i.e., using a placebo run-in design).
757013|NCT00271570||
757014|NCT00271544||Total number of patients enrolled after meeting inclusion/exclusion criteria was 190. Total number of patients that received an implant attempt was 186. Total number of patients with a 4196 lead attempt was 177. Total number of patients successfully implanted with a 4196 lead was 170. Some data was not reported and deviations were recorded.
757015|NCT00271505||The trial was interrupted before the planned 50 patients were enrolled because of slow accrual after bevacizumab became commercially available in the United States for NSCLC treatment.
757016|NCT00271375||
757017|NCT00271219|1074 Patients were screened for eligibility. 175 underwent randomization. 86 were assigned to receive buprenorphine. 58 of the patients assigned to buprenorphine completed the study. 89 were assigned to receive methadone. 73 of the patients assigned to methadone completed the study.|Of the 1074 screened: 243 did not give consent. 656 were excluded for a variety of reasons ranging from an estimated gestation age outside the range, to impending legal issues, to multiple-fetus pregnancy.
757018|NCT00271154|Patients were enrolled from September 2004 through September 2006 at 73 sites located in the United States, Canada, and Europe.|A total of 684 patients were enrolled in the study. Of these, 642 patients were attempted for cardiac resynchronization therapy (CRT) device implant. 21 were unsuccessful, leaving 621 patients successfully implanted with a CRT device. Of these 621 patients, 610 were randomized.
758433|NCT00131508|27 participants were recruited from July, 2004 through October, 2007.|25 of the 27 participants were randomized to either the Glutamine or Placebo arm.
757019|NCT00271102|Dates of recruitment were between 2006 and 2010. Patients were recruited from the urogynecology outpatient clinic at Geisinger.|90 patients were screened for eligibility and 70 were recruited. The remaining 20 either declined participation or were not eligible.
757020|NCT00271024|Enrollment for this study lasted from August 2006-March 2009 with study visits taking place in 3 sites (The University of Chicago, Howard Brown Health Clinic, and the Respiratory Health Association). Follow-up interviews for the study concluded in April 2010.|"N=707 screened for participation (320 met exclusion criteria, 54/387 who passed chose not to participate)
~333 participants were randomized into the trial"
757021|NCT00271011||
757022|NCT00270998|740 women were screened for symptoms of stress only or mixed incontinence symptoms and age of at least 18 years old. 294 did not meet inclusion criteria, one refused to participate and 445 were enrolled.|
757023|NCT00270894|5 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in November 2005 and was completed in June 2008.|Informed consent was obtained from all subjects, and all subjects underwent screening procedures to verify eligibility.
757024|NCT00270855||
757025|NCT00270842||
757026|NCT00270790||
757027|NCT00270634|A total of 334 de novo renal transplant patients were recruited in 36 US and 4 Canadian transplant centres between January 2006 and December 2007.|PROMISE was open to adult recipients of a first deceased or living donor renal transplant. Patients with established renal function (as demonstrated by urine output of at least 40 mL/h and a decline of creatinine of at least 15% from baseline during the first 24 h post-transplant) were randomized.
757028|NCT00270296||
757029|NCT00270257|"The sites were selected based on prior HIV incidence rates among opiate injectors.
~At the first scheduled interim analyses, when 25% of the participants had completed 104 weeks on study, the Data Safety Monitoring Board (DSMB) halted the study due to futility as a result of lower than anticipated HIV incidence rates."|The study represented the first use of buprenorphine-naloxone as a treatment for opiate dependence in each community, thus implementation of the study and recruitment of participants included a significant effort devoted to community engagement and education. Each site had an active community advisory board (CAB).
757030|NCT00270231|Recruitment occurred from March 2004 to August 2005. All subject sessions occurred at the Tobacco Use Research Center's lab, the Biobehavioral Lab (BBL), at the University of Pennsylvania.|The primary genotype of interest was the functional mu opioid receptor (OPRM1). Smokers with the Asp40 variant (A/G or G/G genotypes; about 27% of smokers) were oversampled, relative to those with the more common Asn40 variant (A/A genotype; 73% of smokers), in order to have an equal number of participants in each genotype group.
757031|NCT00270205|Participants were enrolled from February 2006 to October 2008 in 5 different U.S. sites. Enrollment was done by cohort with each cohort enrolling six participants for LC002 vaccine and 2 participants for its corresponding placebo. Cohorts were enrolled sequentially, with later cohorts receiving higher dose of the LC002 vaccine.|Study participants were HIV-1-infected men and women 18-50 years of age with CD4 count >350 cells/mm^3 and plasma HIV-1 RNA <50 copies/ml (on an ultrasensitive assay) and who were on a stable HAART regimen. One enrolled participant never started study treatment/vaccination.
757032|NCT00269919||
757033|NCT00269633||
757034|NCT00269477|Participants were recruited from 20 December 2005 to 31 May 2006, in 8 United States clinical sites.|A total of 145 participants who participated in a previous study MTA02 and other meningococcal-vaccine naive participants were enrolled.
757035|NCT00269399||
757036|NCT00269152||
757037|NCT00269113||
757038|NCT00269087|A study was conducted at 20 centers in Japan from 28 December 2004 to 25 October 2006.|The study period consisted of 2-week run-in period (could be extended up to 4 weeks). Total 174 participants entered into the study, of which 127 participants were screened and entered into run-in phase. Five participants withdrew from the study during run-in phase and total 122 participants received study medication.
757039|NCT00268996|The study was conducted in participants with angiographically documented coronary artery disease (CHD) at 23 sites in 10 countries. The study was initiated on 10 November 2005 and completed on 28 August 2007.|There were 451 participants screened for enrollment of whom 121 failed screening. A total of 330 participants were randomized to receive treatment. Among the randomized participants, 4 from placebo arm and 3 from darapladib arm did not receive study drug. The remaining 323 participants received at least one dose of study drug.
757040|NCT00268983||The study intended to recruit 506 participants to be randomized (1:1) to one of two treatment arms. However, due to feasibility issues, the study was stopped after only 15 participants were enrolled. Of these, 1 participant withdrew prior to receiving the first dose of study treatment; therefore, only 14 comprised the study population.
757041|NCT00268905||
757042|NCT00268892|Participants who completed the main FE200486 CS15(NCT00113753) study (except those in US and Canada) were asked to continue into the FE200486 CS15A extension study.|447 participants started and 374 participants completed the main CS15 study. Of these, 278 participants were recruited into the extension study CS15A and 203 participants signed the informed consent for dose shift.
757043|NCT00268762|Date of first enrollment: May 6, 2003 Date of last enrollment: August 20, 2010 All patients enrolled through hospital emergency departments|
757044|NCT00268463||
757045|NCT00268450||
757046|NCT00268437|This trial closed early because, during an interim analysis, the primary endpoint fell short. However, 26 eligible patients were accrued. Due to early closure not all the endpoints were analyzed.|
757047|NCT00268346|Subjects recruited from April 2003 to January 2010 from medical clinic|
757048|NCT00268242|Patients were treated at the Cleveland Clinic or Duke University Medical Center during the years 2005-2008.|If </= 5 of the initial 18 patients enrolled achieved a CR, the study would be stopped. Accrual was not halted while follow-up of the first 18 evaluable patients was under way. Therefore, 24 patients were enrolled. Only 5 patients (21%) achieved a CR and therefore, the study was terminated.
757049|NCT00268203||NHL=Non-Hodgkin's Lymphoma.
757050|NCT00267969|In this study, 766 patients were randomized in North America and Europe to receive either placebo or ustekinumab (CNTO 1275).|
757051|NCT00267956|146 participants were randomly assigned to receive either placebo or ustekinumab (CNTO 1275) at 24 sites in North America and Europe.|
757052|NCT00267865||
757056|NCT00267670|From March 2005 to March 2008 patients were recruited through the Northwestern Memorial Faculty Foundation Hepatology Clinic.|Subjects were excluded from the study if they had evidence of another form of liver disease or if they were HIV positive, pregnant or had evidence of ongoing alcohol consumption exceeding 20g(males) and 10g(females)daily. Furthermore, subjects were excluded if they were taking drugs known to cause steatohepatitis.
757057|NCT00267644|Patients were recruited from the Pediatric ED from|NO patient was excluded from the trial
757058|NCT00267631|Pediatric Emergency Department|No significant events
757059|NCT00267488||
757060|NCT00267293||
757061|NCT00267202||
757062|NCT00267189||
757063|NCT00267150||
757064|NCT00267111|The study was conducted between July 2003 and December 2004 in the Labour and Delivery Unit of Mount Sinai Hospital.|
757065|NCT00267098||
757066|NCT00267085|Recruitment Period 12/2/05 to 7/1/08. All participants registered at The University of Texas M.D. Anderson Cancer Center.|Eleven participants were registered, one was excluded from study enrollment and did not receive the Chronic Myeloid Leukemia (CML) Vaccine.
757067|NCT00267059|Recruitment Period 12/7/05 - 8/7/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.|Forty five patients were registered on this study. Forty four were evaluable. One patient never received treatment.
757068|NCT00267046|Recruitment Period: 12/2005 to 02/2008. All recruitment done at UT MD Anderson Cancer Center.|Of the 49 enrolled, one participant withdrew before assignment to groups.
757069|NCT00267020||Participant flow reports those participants who discontinued from study drug.
757070|NCT00267007||
757071|NCT00266877||
757072|NCT00266864||
757073|NCT00266851||
757074|NCT00266825|Participants recruited from the Kansas City metro area. Enrollment occurred between January 2006 and November 2009.|
757075|NCT00266812||
757076|NCT00266799|210 participants were enrolled with 105 participants randomized for treatment with PLD and 105 participants randomized for treatment with Capecitabine, of which 7 participants in the PLD group and 3 participants in the Capecitabine group were not treated.|
757077|NCT00266708|Transplant candidates from Montefiore Medical Centre were recruited for the study.|117 transplant candidates were identified as potentially eligible for the study. 57 of the 117 refused to participate and 60 of the candidates signed consent forms. Of the 60 who signed, 18 were either not transplanted or lost to follow-up so only 42 were randomized.
757078|NCT00266695|This study, B7A-MC-MBDV (MBDV), was an open-label extension of Study B7A-MC-MBCM (MBCM; NCT00604383), and was only open to participants who completed Study MBCM. Unless otherwise stated, the time frames refer to this study, MBDV.|
757079|NCT00266656|To be included in this study, participants had to be females with karyotype-proven Turner syndrome who were previously randomized in Study B9R-US-GDFG (NCT00406926).|
757080|NCT00266630||
757081|NCT00266409|Participants Flow shows 418 subjects that have been enrolled and randomized. The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.|Baseline Characteristics are only available for the Intent-to-treat population (subjects who received one dose of SSRI/SNRI and/or Niravam and have an assessment beyond the Baseline assessment)
757082|NCT00266279||
757083|NCT00266227||559 participants received initial treatment open label rituximab. 84 of these participants were not randomized to Retreatment.
757084|NCT00266110|Participants were recruited from University of North Carolina (UNC) at Chapel Hill.|105 patients were consented for this study, 103 were on-study, and 17 began treatment.
757085|NCT00266032|Randomization scheme in the subgroups was 1:1:1 for the 2 centers performing biopsies and measurements of Bone Mineral Density and metabolic parameters (82 subjects per treatment group). The remaining subjects were randomized according to the ratio 4:1:1.|"146 subjects failed screening, 96 of these 146 (65.8%) because inclusion or exclusion criteria were not met, 21 (14.4%) due to withdrawal of consent, 17 (11.6%) because of other reasons, 11 (7.5%) due to protocol deviations, 1 (0.7%) was lost to follow-up. 32 randomized subjects never took medication."
757086|NCT00265980||
757087|NCT00265941||
757088|NCT00265889|Patients recruited from medical clinic from August 2002 thru October 2010.|Only Poor Risk Patients were enrolled.
757089|NCT00265850||From 5/2005 to 9/2009, patients were randomized 1:1:1 to Arms A, B and C. Study was amended in 2009 to include only KRAS wild type patients; then Arm C was closed based on data showing no benefit from chemo with the combination of Bevacizumab and an EGFR antibody. Thereafter, only KRAS wild type patients were randomized 1:1 to Arm A and B.
757090|NCT00265798|Patients were enrolled from 6 centers between 2006 and 2009|
757091|NCT00265785||
757092|NCT00265759|Z1031A enrolled postmenopausal women with stage II/III ER+ (Allred 6 to 8) breast cancer (BC) whose treatment was randomized to neoadjuvant AI therapy with anastrozole, exemestane or letrozole. For Z1031B the protocol was amended to include a tumor Ki67 determination after 2-4 weeks of AI.|
757093|NCT00265616|Rcruitment in participating centers took part between 2006 and 2010.|
757094|NCT00265564||
757095|NCT00265538|An intervention study was implemented. Both the Iowa City VA and associated outpatient clinics as well as the Minneapolis VA and associated clinics were sites chosen for this intervention study. Subjects with a diagnosis of uncontrolled Hypertension or Hypertension controlled by a CCB were recruited.|61,019 potential subjects from the 13 clinics were screened using an automated protocol to identify 2,910 potentially eligible subjects
757096|NCT00265512||
757097|NCT00265473||
757098|NCT00265395||1428 patients enrolled; 159 patients qualified as slow responders per treatment week 12 and 24 protocol-specified eligibility criteria; 159 patients were randomized
757099|NCT00265382|This study enrolled adolescent subjects with schizophrenia, ages 13-17 years, who participated in the double-blind placebo controlled Study A1281134 (NCT00257192) who met qualification criteria and wished to receive treatment with open-label ziprasidone.|
757100|NCT00265343||
757163|NCT00260962|Eligible participants were recruited from patients referred to the eating disorders program at The Ottawa Hospital by a family physician or psychiatrist between September 2000 and April 2006.|
757101|NCT00265330|The number of subjects entering this trial was determined by the number of subjects electing to continue treatment after completing or withdrawing from the preceding double-blind study (A1281132: NCT00257166).|A total of 169 subjects from the parent study were assigned to the extension study and 162 continued on and received study treatment in the extension study.
757102|NCT00265317||
757103|NCT00265239||
757104|NCT00265200||
757105|NCT00265148|This study was conducted from 18 May 2004 to 10 July 2008 at centers across Canada, the United States (US), and the United Kingdom (UK). A total of 80 participants with mild to moderate Alzheimer's disease were planned to be enrolled.|A total of 135 participants were screened of which 80 participants were randomized, during which they received oral Rosiglitazone-extended (RSG-XR) release 4 milligrams (mg) once daily. Intent- to-treat (ITT) population included 78 participants who had more than or equal to 1 efficacy, pharmacokinetic, pharmacodynamics, or genetic assessment.
757106|NCT00265122|A total of 131 participants (104 in Population 1 and 27 in Population 2) were enrolled among 42 study centers (35 centers in the US, 6 in Canada, and 1 in Belgium) to receive treatment with placebo or ustekinumab (CNTO 1275) administered subcutaeously (injected under the skin [SC]) or intravenously (infused in a vein [IV]).|Participants with moderate to severe active Crohn's Disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents were enrolled and referred to as Population 1 and those with active disease who failed to respond to infliximab were enrolled and referred to as Population 2.
757107|NCT00265109||
757108|NCT00265096|405 patients were randomized at 57 centers: 35 in North America (17 in the United States and 18 in Canada) and 22 in Europe (5 in Belgium, 10 in Poland, 3 in Spain, and 4 in the United Kingdom). The first patient was enrolled on 12 Dec 2005. The date of the last patient visit for the week (Wk) 24 reporting period was 14 May 2007.|
757109|NCT00265083|356 patients were randomly assigned to treatment groups at 42 sites (17 in North America, 16 in Europe and 9 in Asia). Consent was obtained from the first patient on 13 Dec 2005. The last patient completed the final visit of the 24-week reporting period on 15 May 2007. The last patient completed the final visit of the 5-year period on 17 Jan 2012.|
757110|NCT00264875|With completion of A0081066 (NCT00232141), subjects had option of initiating treatment with pregabalin under open-label conditions for 3 months in A0081095, an open-label extension trial. Treatment in A0081095 was initiated on the evening of the subjects' Visit 7/Termination Visit in A0081066. A0081095 was conducted in the United States.|
757111|NCT00264849||
757112|NCT00264810|Subjects were recruited at Level 4 epilepsy centers, as categorized by the National Association of Epilepsy Centers (NAEC), through the United States.|Besides continuing to meet all I/E criteria, in order to undergo initial implant and be assigned to a group (randomized), subjects were required to maintain an average of 3 or more disabling partial seizures per month and remain on the same AED regimen (except for acute, intermittent use of benzodiazepines), for 3 consecutive months (12 weeks).
757113|NCT00264797|This trial was conducted by the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) between March 2006 and October 2008. Eleven community based treatment programs recruited participants.|
757114|NCT00264641||
757115|NCT00264576||
757116|NCT00264550|A total of 444 participants were enrolled at 60 sites in 12 countries.|
757117|NCT00264537|A total of 637 participants were enrolled at 90 centers: 25 sites in Asia, 34 sites in Europe/Australia/New Zealand, 10 sites in Latin America and 21 sites in North America.|
757118|NCT00264498|Patients were recruited at 2 Canadian cancer clinics between October 2004 and October 2007.|"Following enrolment there was a 7 - 28 day screening period, after which if all inclusion/exclusion criteria were met, patients were randomized to treatment.
~Following objective disease progression on randomized treatment (Period 1), subjects were encouraged to crossover to the other treatment (Period 2)."
757119|NCT00264381|Consecutive patients, inpatient and outpatient, with ultrasound confirmed superficial thrombophlebitis of the upper or lower extremity|Exclusion criteria: receiving anticoagulant therapy for more than 24 hours, concurrent DVT, active bleeding, hypersensitivity to NSAIDS, pregnant or <1 week post-partum, history of bleeding gastric ulcers, hemorrhagic CVA in last year, platelet count<100K, bleeding disorder, serum creatine > 2mg/dl, BP > 180/110, weight <40kg or >135kg
757120|NCT00264303||976 patients have been screened for this study. Ninety patients were ineligible for randomization, 886 have been randomized and treated. Participants flow and Baseline Characteristics refer to all patients randomized and treated.
757121|NCT00264290|Cytomegalovirus (CMV)-seropositive adults with chronic HIV infection were recruited at one US clinical site.|Of 60 screened subjects, 3 refused participation and 27 did not meet eligibility criteria. The most common reason for exclusion was <10% activated Cluster of differentiation * (CD8)+ T cells.
757122|NCT00264238|From February 2006 to February 2008, participants recruited from the Stanford School of Medicine Department of Psychiatry and Behavioral Sciences OCD clinic and through online adds. Subjects had to have had failed to respond to at least 12 weeks of treatment at an adequate and stable dose of an serotonin reuptake inhibitor (SRI) (YBOCS of GE 18)|
757123|NCT00264147|90 multicenter rheumatologists: US (71), Canada (14), Colombia (3), Switzerland (2), recruited 761 study patients from their patient pool and through advertising. First Patient In 04-Jan-2006, Last Patient Last Visit 26-Mar-2008.|"Patients must have taken Non Steroidal Anti-inflammatory Drugs (NSAIDs) at a therapeutic labeled dose on a regular basis and demonstrated a clinical response in the past and at screening. Following a protocol-specified washout, patients must have demonstrated disease activity and worsening in symptoms of Rheumatoid Arthritis from the screening."
757124|NCT00264004||
757125|NCT00263887|Multicenter study with 3 sites in Denmark, Sweden, and the United Kingdom.|
757126|NCT00263757||
757127|NCT00263666||In case of discrepancy between the HIV results (DNA PCR positive, viral load negative), performed at the Screening Visit (one week prior to first vaccination) the infants were not enrolled in the study.
757160|NCT00261495|Study conducted in 11 countries (Czech Republic, Denmark, France, Germany, Italy, Norway, Poland, Slovakia, Slovenia, Sweden, and Switzerland). 63 study centres randomized subjects and 1 centre screened 1 subject but did not randomize. Recruitment period: 15 March 2006 (first patient in) to 31 March 2007 (last patient in).|
757161|NCT00261443||
757341|NCT00247273|Screening period began 17 Oct '05|
757128|NCT00263588|"The Intent-to-Treat (ITT) Population: all subjects who received at least one dose of study medication
~Modified ITT (MITT) Population: all subjects who received at least four doses (750 mg lapatinib twice daily for two days) of study medication and who had measurable brain metastases (≥1 cm in diameter) at baseline assessment"|Main phase: ITT 95 in Cohort A, 147 in Cohort B. MITT, 94 in Cohort A, and 143 subjects in Cohort B Optional open-label extension phase: 51 subjects. Long-term follow up (LTFU) Protocol amendment added on 15-Apr-2013
757129|NCT00263575|"Recruitment period was first patient screened in December 2005 to last patient screened in November 2008.
~Patients were recruited from Medical Institutions in the US."|Patients with stable cancer-related pain receiving stable, fixed-schedule oral opioid regimen. Patients were not permitted to have 2 consecutive days without at least 1 episode of BTcP. This regimen was for 14 days prior to screening and was expected to remain unchanged for the titration period. Patients with ulcerative mucositis were permitted.
757130|NCT00263562||
757131|NCT00263328||
757132|NCT00263211|This study opened for enrollment in January 6, 2006 and closed enrollment in May 25, 2010|
757133|NCT00262964|Beginning and ending recruitment dates: Beginning - 10/20/04; Ending - 09/24/07. Recruitment occurred only at Washington University in St. Louis.|We screened 138 subjects. 80 would-be participants failed the screening. This was often due to not having Non-alcoholic Fatty Liver Disease. Other subjects were excluded due to use of various medications or the presence of some excluded disease such as type 2 diabetes. Of the 58 that passed screening 51 chose to enroll in the study.
757134|NCT00262951|All patients participated in Part 1 of the study only.|
757135|NCT00262925||
757136|NCT00262873|23 patients were screened for the study.|15 patients did not meet study eligibility criteria.
757137|NCT00262860||
757138|NCT00262847|Between October 2005 and June 2009, 1873 women were enrolled from 336 institutions in the United States, Canada, South Korea, and Japan.|
757139|NCT00262834|Women enrolled from two sites, Johns Hopkins Medical Institutes and Anne Arundel Medical Center. Informed consent was obtained from all participants in the vorinostat and control groups.|Women must have adequate performance status and blood counts/organ function; no hormones within 30 days of diagnostic biopsy, prior or concomitant treatment for the current cancer, or uncontrolled intercurrent illness that could limit compliance were allowed.
757140|NCT00262821||Eligible and evaluable patients.
757141|NCT00262743|A total of 73 participants were enrolled at the Mayo Clinic from August 2005 - October 2009.|Thirty-six (36) and 37 patients recruited to the phase I and phase II portions, respectively. Three phase I patients were replaced and one patient was ineligible for evaluation. Per study design, the 36 eligible phase II participants along with the 6 phase I participants treated at the phase II dose level were evaluated (n=42).
757142|NCT00262730|outpatient clinic|
757143|NCT00262639||
757144|NCT00262600||
757145|NCT00262522|Subjects were enrolled at 131 sites in 19 countries.|Of the 672 subjects randomized, 8 discontinued from the study prior to receiving study drug due to withdrawal of consent (3), acute illness (2), lost to follow-up (1), other (1), and required prohibited medication (1).
757146|NCT00262509|Subjects were recruited from July through September, 2009. They were recruited from the VA Medical Center Eye Clinic and the Atlanta Center for Visual Impairment.|17 participants recruited after 23 potential participants contacted by phone from our VA subject registry. Of the 23 contacted, 3 screened out as not meeting inclusion criteria, and 3 chose not to participate.
757147|NCT00262314|Trial Initiation Date: 17 October 2000 (date of first subject first visit). Trial Completion Date 15 July 2008 (date of last subject last visit). 46 centers enrolled at least one subject.|
757148|NCT00262301|"During the double-blind phase of the study, patients were randomized once to receive 100 IU/kg rhC1INH or Saline in a ratio of 1:1. After conclusion of the double-blind phase, patients with subsequent eligible attacks could be treated with open-label 1 vial (2100 IU) of rhC1INH."|Patients could be enrolled into the open-label phase of the study after conclusion of the double-blind phase.
757149|NCT00262223|Participants in the metropolitan New York area were recruited through newspaper and radio advertisements, flyers, and referrals from outpatient mental health centers between April 2006 and March 2012.|Individuals were screened through a brief telephone interview and then completed a baseline interview. After baseline assessment and medical clearance, eligible participants began a one-week, single-blind placebo lead-in phase. Those who completed the lead in phase were accepted into the study.
757150|NCT00262119|The recruitment period was between February 2006 and April 2010. Patients were enrolled in cardiology departments.|A total of 1300 patients were enrolled in the study. Enrollment was followed by a 1-month run-in period. Patients with ventricular pacing ≥ 95% on device check in the run-in period were excluded from the study. At the end of the run-in period, randomization was performed. In all, 1166 patients were randomized and followed up.
757151|NCT00262080||Patients were screened in advance of presenting with an Hereditary Angioedema (HAE) attack but were randomized only upon attack.
757152|NCT00262067||
757153|NCT00262041|Subjects were enrolled at Seattle, Washington; Pittsburgh, Pennsylvania; Rochester, Minnesota.|All enrolled subjects were included in the trial.
757154|NCT00262028|Subjects were recruited from a single center.|All enrolled subjects participated in this study.
757155|NCT00262002|Participants were enrolled at two centers in Canada and one in UK.|The two selected countries provided data on different infant vaccination schedules (at 2 and 4 months of age; at 2, 3, and 4 months of age: and at 2, 4, and 6 months of age), and on different recommended concomitant vaccinations.
757156|NCT00261950|May 22 2006 is study initiation date and 13 May 2011 is study completion date.|
757157|NCT00261846||
757158|NCT00261833|This multicenter, multinational study enrolled participants at 28 study centers in Europe, North America, and Australia.|Screening took place 1 to 4 weeks prior to the first dose of randomized investigational product (ie, either Zemaira® or placebo). A total of 208 participants were screened; 28 of these did not fulfill all eligibility criteria and were therefore screening failures.
757159|NCT00261716||
757162|NCT00261040||Patient recruitment occurred at the Ottawa Hospital (General Campus) by one of two co-investigator surgeons trained in MIS of the hip. Randomization occurred on the day of surgery in order to minimize the potential number of dropouts.
757164|NCT00260832|This study was recruited at 65 centers in 12 countries during the period of 2006 to 2009.|Prior to randomization, subjects indicated their preference for treatment, with physician's advice, or either cytarabine or supportive care in the event they were randomized to Arm A.
757165|NCT00260689||
757166|NCT00260533|Outpatient recruitment.|
757167|NCT00260429||
757168|NCT00260208||361 patients were randomized, 185 to the cyclosporin A arm and 176 to tacrolimus. Five patients (1 cyclosporine A, 4 tacrolimus) did not receive any dose of study medication and were therefore excluded from the safety population.
757169|NCT00260195|We recruited and screened 6th and 7th grade students in two schools over two school years (2005-2006 and 2006-2007) in Los Angeles Unified School District.|There are 3 steps in enrollment: consent for screening, screening, consent for participation for those who screened positive. 383 students were screened, 193 screened positive, 78 consented for the project (active parental consent and child assent). 2 students withdrew from the school prior groups and thus did not participate further.
757170|NCT00260065||
757171|NCT00259857|Dates of recruitment period:O5/27/2004 to 02/01/2006. Types of location:outpatient clinic, Clinical and Translational Research Center (CTRC), Medical University of South Carolina, Charleston, South Carolina.|
757172|NCT00259740|Participants were enrolled from 13 February 2006 through 8 December 2006|
757173|NCT00259649||
757174|NCT00259610|Recruitment began in May 2004 and concluded in January 2007.|This study had a screening period of 1-3 days, Patients were excluded for various reasons, including, laboratory exclusions, Positive TB test, and Cataract/visual defect.
757175|NCT00259298||
757176|NCT00259285||
757177|NCT00259272||All participants received olanzapine and were grouped according to their most recent type of episode.
757178|NCT00259090|Postmenopausal women with oestrogen receptor positive breast cancer, awaiting curative-intent surgery were recruited to 4 medical centres within the UK.|121 patients had baseline biopsy and were randomised 1:1:1. 120 patients received 14 to 21 days therapy. Surgery was actually performed between day 13 and 28 and a tumour sample was taken. Safety data is presented for all 120 patients who received therapy. The demography data are summarized for the population who had a usable tumour sample.
757179|NCT00259012|Patients were recruited February 2006 to January 2008.|Patients were screened for seven days.
757180|NCT00258960|Between February 2006 and June 2008, 49 patients were enrolled at 12 Spanish sites. One patient never received treatment due to early death from progressive disease and was not included in this analysis.|
757181|NCT00258908|Study participants were enrolled from 01 November through 07 December 2005 in 1 medical clinic in Taiwan|A total of 115 participants that met the inclusion and exclusion criteria were recruited for the study; 112 were vaccinated and included in the final analysis and this report.
757182|NCT00258895|Participants were enrolled from 30 March 2005 to 02 March 2006 at 22 US sites.|A total of 649 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
757183|NCT00258882|Study participant accrual occurred from 02 September 2005 through 16 October 2006 using 3 Kaiser Permanente databases.|Databases were reviewed to identify persons who received Adacel vaccine and Td vaccinated historical controls. Two statistical analysis methods were used, risk interval and historic cohort method. Adacel-exposed pregnancy cases were matched to non-exposed pregnant controls (3:1 ratio).
757184|NCT00258856|Participants were recruited in 18 US clinic sites from 14 January 2006 through 05 June 2006.|A total of 234 participants that met the inclusion but none of the exclusion criteria were enrolled and vaccinated.
757185|NCT00258830|Study participants were enrolled from 09 September to 18 October 2005 in one medical clinic in the US|A total of 120 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated.
757186|NCT00258817|Subjects were enrolled from October to December 2005|A total of 30 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated
757187|NCT00258674||
757188|NCT00258440|Subjects were adults age >=18yrs, with solid tumors, and who received treatment. A total of 25 subjects were recruited. Potential study subjects were seen in a routine clinical setting or referred for study purposes. The PI, physician or the research nurse approached subject and to get informed consent, as well as screen for eligibility.|
757189|NCT00258362|42 patients consented originally, but 1 patient withdrew consent before receiving any treatment.|
757190|NCT00258349|The phase I portion of the study was activated on August 23, 2006, and completed on June 28, 2007. The phase II portion of the study then was activated, and suspended on October 4, 2007, terminated on August 27, 2009, with a final accrual of 16 patients by ECOG institutes.|
757191|NCT00258310||
757192|NCT00258206||
757193|NCT00258180||1 subject was not assigned intervention due to PI decision.
757194|NCT00258154|Enrollment occurred at 26 sites in Austria, Belgium, and Germany from 22Feb2006 (first subject in) to 13Nov2006 (last subject out). Cutoff date for all clinical and laboratory data from the Case Report Forms in-house was 08Jun2007. Access to the clinical database was granted on 15Jun2007.|Excluded from randomization were patients with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive, clinical evidence of active gastrointestinal illness and those with fever, a rectal temperature >38.1°C (>100.5°F) at time of immunization.
757195|NCT00258128|This study was active between 2000-2008. The location was an accademic clinic setting in the USA.|Subjects were instructed to monitor fasting blood glucose levels and with symptoms of hyperglycemia or hypoglycemia, and to avoid changing dietary or exercise habits.
757196|NCT00258011||
757197|NCT00257933||
757198|NCT00257920||Subjects assigned randomly in a 1:1 manner to Sequence Group I or II. Group I received Drug A (6 mcg Zemplar Injection QOD for 6 doses) in Period 1 and Drug B (3.6 mcg Hectorol Injection QOD for 6 doses) in Period 2. Each treatment period was 14 days and a 14 day washout separated the treatment periods.
757199|NCT00257894|Participants were veterans recruited from the Veterans Affairs Medical Center, Veterans Affairs Medical Center staff, visitors, and smokers recruited from the community.|Nine people washed out or failed to return before assignment to groups, or were assessed with an invalid informed consent so the IRB required their data to be excluded from all analyses, and no demographic information is available on these people, leaving n = 32 with at least age and gender.
757200|NCT00257725|Participants were recruited through the NYSPI Child and Adolescent Evaluation Service (CAPES), physician referrals, local and web advertising, and flyers. Recruitment took place between March 2005 and August 2007|The study included screening and one-week washout (if needed). All participants were entered into the study without incident.
757201|NCT00257686||
757202|NCT00257660|Patients were recruited at 16 centres in the USA and 4 centres in Russia from October 2005 until September 2006|
757203|NCT00257608|This study was conducted in 14 countries between 10 January 2006 and 19 June 2009.|
757204|NCT00257556||Ninety (90) participants were screened and 80 participants randomized.
757205|NCT00257322|20 subjects enrolled between Jun 2003 and Jan 2007 in UCIMC location. All subjects undergoing treatment are presented with all options for their care - research or non-research.|Subjects with known allergic or other adverse reaction to GM-CSF are excluded from study. Also pregnant and lactating women were excluded from study.
757206|NCT00257309||
757207|NCT00257192|A planned interim analysis resulted in recommendation from Data Safety Monitoring Board (DSMB) to terminate study due to futility per the interim analysis charter (p-value = 0.9840). Only one active subject in the study was affected by this decision.|Screening visit followed by a 1 to 10 day period to allow for wash-out of exclusionary medications.
757208|NCT00257166||
757209|NCT00257010|This study was conducted at 55 sites in the United States.|Of the 447 participants enrolled, 420 participants took at least one dose of study drug according to the Headache Record and were included in the analysis.
757210|NCT00256997||
757211|NCT00256984||
757212|NCT00256867|The study was conducted between 17 April 2005 and 21 December 2006 at 68 centers in five countries including United States, Canada, Australia, Mexico, and the Philippines. A total of 370 participants were randomized of which 1 participant did not received study medication remaining 369 participants were included in safety population.|Out of the 369 participants from safety population, 12 participants received at least one dose but did not have at least one On-Therapy value for any efficacy assessment, the remaining 357 participants were included in Intent- to-Treat population.
757213|NCT00256854|This study was conducted from 14 November 2005 till 21 September 2006 across 27 centers in the United States (US).|Participants with RLS were screened for 1 week; however, it could had been extended maximum up to 4 weeks. During screening period, participants received Ropinirole immediate release (IR) 1 milligrams (mg), 2 mg, or 4 mg across Cohorts A, B, and C. A total of 135 participants were randomized in the study.
757214|NCT00256750||738 participants enrolled, 686 randomized. Reasons for non-randomization include 5 participants withdrew consent, 1 lost to follow-up, 34 no longer met study criteria, and 12 for other non-listed reasons. 666 participants randomized, but not transplanted. 20 not transplanted; 10, 4, 6 in the CsA, Belatacept LI, Belatacept MI, respectively.
757215|NCT00256724|Patients were recruited from the emergency department based on age (18-85)and systolic blood pressure ≤95mmHg who were conscious and presumed to have hypotension due to hypoivolemia or relative hypovolemia (blood loss, dehydration, or sepsis).|
757216|NCT00256698|258 patients were randomised to Fulvestrant + Anastrozole and 256 patients were randomised to Anastrozole. In each treatment group, there were 2 patients who did not receive any trial therapy and so have been excluded from the safety summaries.|
757217|NCT00256451||Participants were only randomized to 4 sequences and not to all 12 possible sequences.
757218|NCT00256308|Study start date: February 2005 Primary completion date: May 2010 Study completion date: October 2011|
757219|NCT00256295|Study start date: April 2005 Primary completion date: February 2008 Study completion date: October 2011|
757220|NCT00256282||
757221|NCT00256243|Subjects recruited At University of California Irvine Medical Center (UCIMC) are recruited by referral for UCIMC inpatients or outpatients.|
757222|NCT00256204||
757223|NCT00256126|First informed consent date: May 2005. Clinical data cutoff date: Oct 2007, Study completion date: Sep 2007.|A total of 319 subjects were screened for this trial. Only 1 subject withdrew from the study prior to receiving the treatment due to personal reasons. Overall, 318 subjects were enrolled into the study.
757224|NCT00255970|Recruitment was done through the investigators clinics.|The was no wash out or run-in events in this study.
757225|NCT00255944||
757226|NCT00255840|HIV-positive adult participants were recruited from February 2005 to December 2007 from two primary health care clinics, one in Masiphumelele, Cape Town and the other in Soweto, Johannesburg.|
757227|NCT00255801||
757228|NCT00255723||
757229|NCT00255684||
757230|NCT00255346|Sixty-Seven participants were registered and received the study medication for this study.|
757231|NCT00255190|Subjects were enrolled at 104 sites in the United States from 07 January 2006 to 25 June 2008.|At screening, subjects completed a Patient Assessment of Upper Gastrointestinal Disorders Quality-of-Life Index (PAGI-QOL) and Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaires before enrollment in Dexlansoprazole Modified Release (MR) 60 mg or 90 mg once daily (QD) treatment groups.
757232|NCT00255177||
757233|NCT00255164|Subjects were enrolled at 105 sites in the United States; date of first dose (04 January 2006; date of last procedure: 14 November 2006).|Subjects had to have endoscopically proven healed erosive esophagitis (EE) after 4 to 8 weeks of treatment with Lansoprazole 30 mg once-daily (QD), Dexlansoprazole Modified Release (MR) 60 mg QD, or Dexlansoprazole MR 90 mg QD in the EE healing studies, T-EE04-084 (NCT00251693) and T-EE04-085 (NCT00251719).
757234|NCT00255151|Subjects were enrolled at 105 sites in the United States; date of first dose (04 January 2006; date of last procedure: 14 November 2006).|Subjects had to have endoscopically proven healed erosive esophagitis (EE) after 4 to 8 weeks of treatment with lansoprazole 30 mg once-daily (QD), dexlansoprazole modified release (MR) 60 mg QD, or dexlansoprazole MR 90 mg QD in the EE healing studies, T-EE04-084 (NCT00251693) and T-EE04-085 (NCT00251719).
757235|NCT00255125||
757236|NCT00255086|17 subjects were randomized. All subjects had completed all participation by October, 2008. All were recruited at VA Palo Alto Health Care System.|
757237|NCT00255047|Participants were enrolled from 10 November 2005 through 21 September 2006 in 38 Clinics in the Untied States.|A total of 2167 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on Stage I, up to the 3rd dose are presented.
757238|NCT00255034|The target recruitment was not attained within the anticipated study time-frame and so study recruitment was ceased on 24 November 2006; however those patients already enrolled in the study continued in the study until completion.|Enrolled 146 subjects; 143 subjects were treated; 3 subjects were withdrawn at Baseline and never received study medication: 1 subject in the 24 weeks group due to consent issues; and 2 subjects in the 48 weeks group (1 subject was ineligible and 1 subject was randomized in error).
757239|NCT00255008||
757240|NCT00254995|Study participant accrual occurred from 15 July 2005 through 14 April 2006.|Databases were reviewed to identify persons who received Menactra vaccine within Kaiser Permanente and to identify all medical care events for the 6-month period following vaccination or, if applicable, through the end of pregnancy. Subjects served as their own control for 0-30 days surveillance, age-matched control served for the 6-month period.
757241|NCT00254982||
757242|NCT00254592|Subjects were recruited at UCIMC by the following methods: referral for University of California Irvine Medical Center (UCIMC) inpatients or outpatients.|
757243|NCT00254566||398 subjects were enrolled and 396 subjects received treatment. Two subjects who were assigned to moxifloxacin did not receive at least one dose of treatment.
757244|NCT00254540||
757245|NCT00254501||
757246|NCT00254488||
757247|NCT00254462|Subjects were recruited in outpatient child psychiatry clinics at 3 academic institutions between October, 2005 and June 2008.|The ADHD diagnosis was confirmed using standardized measures and cases were reviewed on conference calls by professionals from all 3 sites.
757248|NCT00254410|Recruitment Period: March 2005 to April 2006. All recruitment done at The University of Texas MD Anderson Cancer Center.|
757249|NCT00254397|Dates of Recruitment Period: November 8, 2005 to August 11, 2009. All participants recruited the University of Texas (UT) MD Anderson Cancer Center.|
757250|NCT00254293|Short term (12 week) randomized Period: started January 2006/completed May 2007. Long term extension (LTE): started April 2006/completed July 2012. During LTE: variable dose period and fixed dose period. Patients with active Rheumatoid Arthritis (RA) and receiving disease modifying anti-rheumatic drugs (DMARDS) were eligible to participate.|Enrolled/not treated (19): prior treatment not washed out; no longer met study criteria; withdrew consent before treatment. To enter LTE, participant completed the short term period, and was assigned to a variable SC dose group (75, 125, 200 mg SC abatacept) based on body weight; completers of variable dose LTE rolled over into fixed dose LTE.
757251|NCT00254163||
757252|NCT00254072|Patients were recruited within bariatric surgery clinic at each institution|
757253|NCT00253981|The recruitment took place between 2006-2007 at a military treatment facility.|Some participants were excluded due to deployment, military training that required them to leave the post.
757254|NCT00253890|Participants were recruited from 8 methadone maintenance clinics in the Providence, RI area.|
757255|NCT00253747|This trial was conducted by the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) between December 2005 and January 2008. Six study sites recruited participants: 2 substance abuse community treatment programs, 2 Attention Deficit Hyperactivity Disorder (ADHD) clinics and 2 smoking cessation clinics.|
757256|NCT00253708|Using oncology clinic electronic database, eligible patients were selected based on their clinical diagnosis (solid cancer with evidence of metastases) and whether they lived within 25 miles of the hospital. Patients were told that the authors were conducting a study of nonpharmacologic treatments intended to improve symptom management.|
757257|NCT00253643||
757258|NCT00253630||
757259|NCT00253513|Patients recruited at OHSU Knight Cancer Institute clinics in Portland, Oregon and Fred Hutchinson Cancer Research Center or University of Washington Medical Center clinics, Seattle, Washington.|
757260|NCT00253448|Subjects recruited from 12/31/2002 to 5/8/2008 from medical clinic|One patient was not eligible for unknown reason
757261|NCT00253435|"Opened to accrual on 12/10/04 & closed to accrual on 07/21/10; suspended 6 times for amendments. Opened at 12 NANT institutions.
~1st patient started on treatment on 03/11/05. 50 patients enrolled; all eligible & evaluable for toxicity. 49 patients were evaluable for response."|
757262|NCT00253370|Participants were recruited from ECOG member institutions between October 28, 2005 and July 2, 2007. The final accrual was 44 patients.|
757263|NCT00253019|Participants were recruited from a medical clinic beginning in 10/2004 through 11/2005.|All patients were invited to participate.
757264|NCT00252967||
757265|NCT00252733|First subject enrolled in the DIRECT Programme 8 June 2001 and last subject completed the DIRECT Programme 16 April 2008 mainly in hospital based clinics. 4514 patients type 1 diabetes were enrolled of whom 1421 proceeded to randomization, 711 to the candesartan arm and 710 to the placebo arm.|The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.
757266|NCT00252720|First subject enrolled in the DIRECT programme 8 June 2001 and last subject completed the DIRECT programme 16 April 2008 mainly in hospital based clinics. The study investigators enrolled 4514 patients with type 1 diabetes to either Study 45 or 46, of whom 1905 proceeded to randomization into Study 46 (1421 into Study 45).|The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.
757267|NCT00252694|First subject enrolled in the DIRECT Programme 8 June 2001 and last subject completed the DIRECT Programme 16 April 2008 mainly in hospital based clinics. A total of 4717 patients enrolled into the programme of whom 1905 patients proceeded to randomization into Study 47.|The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.
757268|NCT00252629|"18 male veterans with GWI and Sleep Disordered Breathing recruited by advertisement, they were splitter into a matched two groups: 9 veterans received active nasal CPAP and 9 veterans received sham nasal CPAP.
~Additionally, we recruited asymptomatic 11 male veterans of Gulf war."|
757269|NCT00252590||
757270|NCT00252577|Subjects with bipolar disorder were recruited through the San Diego VA Mood Clinic|
757271|NCT00252564|A total of 247 patients were recruited from multiple research sites and were randomly assigned to either Arm A or Arm B between December 2005 to June 2007.|The patients were required to be in screening for up to 3 weeks prior to registering the patient for randomization
757272|NCT00252538|A total of 133 participants from non- VA and VA sites were included for the genetic analysis. Patients from VA sites were recruited through/ referred by the local hepatology clinics. Recruitment occured from 4/6/2006 to 9/1/2009. A second manuscript included VA participants only.|"Exclusion Criteria:
~Diagnosis of active: depression, psychotic symptoms, or bipolar disorder (or history of bipolar disorder) during the previous 3 months
~On antidepressant medications for any reason
~Currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months."
757273|NCT00252512||Two participants withdrew from participation after random assignment to the placebo condition and did not start the intervention.
757274|NCT00252499|Subjects were recruited between 2006 and 2011 through referral from local gastroenterologists.|Subjects underwent a screening visit prior to randomization to ensure that they qualified for the study.
757275|NCT00252382||
757276|NCT00252239||
757277|NCT00252187|Participants were recruited from May 2003 to May 2008 at the Mayo Clinic in Rochester, Minnesota.|
757278|NCT00252174||
757279|NCT00252057|All participants were recruited between January 1, 2006 and October 16, 2007, from the general medical floors at Boston Medical Center.|The baseline interview was conducted after enrollment and prior to group assignment, but it did not affect this assignment or lead to exclusion from the study for any participant. All participants who gave consent and agreed to be in the study were assigned to a group
757280|NCT00251979||
757281|NCT00251927|The first patient was enrolled on 16 October 2001. Last patient completed the last visit on 07 April 2009.|The study started with a 12-week run-in period. Patients had either been treated or untreated with a proton pump inhibitor (PPI) prior to entering this phase of the study.
757282|NCT00251862||
757283|NCT00251758|Subjects enrolled at 157 sites in the United States (75 in Study T-GD04-082 [NCT00251745] and 82 in Study T-GD04-083 [this posting, NCT00251758]; date of first dose: 07 December 2005; date of last procedure: 23 May 2006).|Subjects with endoscopically documented normal esophageal mucosa were enrolled in Dexlansoprazole Modified Release (MR) or Placebo once daily (QD) treatment group; subjects were instructed that lifestyle or behavioral modifications designed to treat their symptoms of Gastroesophageal Reflux Disease (GERD) should not be altered throughout the study.
757284|NCT00251745|Subjects enrolled at 157 sites in the United States (75 in Study T-GD04-082 [this posting, NCT00251745] and 82 in Study T-GD04-083 [NCT00251758]; date of first dose: 07 December 2005; date of last procedure: 23 May 2006).|Subjects with endoscopically documented normal esophageal mucosa were enrolled in Dexlansoprazole Modified Release (MR) or Placebo once daily (QD) treatment group; subjects were instructed that lifestyle or behavioral modifications designed to treat their symptoms of Gastroesophageal Reflux Disease (GERD) should not be altered throughout the study.
757285|NCT00251719|Subjects were enrolled at 93 sites in the US and 63 ex-US sites from 16 December 2005 to 22 January 2007.|Subjects recorded day and nighttime heartburn symptoms and rescue medications for a screening period of up to 21 days. Subjects with endoscopically-proven erosive esophagitis (EE) at screening were enrolled in Dexlansoprazole Modified Release (MR) or Lansoprazole once daily (QD) treatment group.
757286|NCT00251693|Subjects were enrolled at 95 sites in the United States (US) and 55 ex-US sites from 02 December 2005 to 30 January 2007.|Subjects recorded day and nighttime heartburn symptoms and rescue medications for a screening period of up to 21 days. Subjects with endoscopically-proven erosive esophagitis (EE) at screening were enrolled in Dexlansoprazole Modified Release (MR) or Lansoprazole once daily (QD) treatment group.
757287|NCT00251641||
757288|NCT00251589|This study was conducted at 12 investigative sites in the United States. The first patient's first visit was 30 March 2006. The study was terminated early on 12 Oct 2007 and the last patient's last visit was 30 Oct 2007.|Enrolled patients were assigned to 1 of 2 dose escalating cohorts (A and B) in the Phase I portion of the study to determine the maximum tolerated dose (MTD). Once determined, new patients were assigned to the Phase II portion of the study and treated with the MTD. Active Phase I patients continued into Phase II.
757289|NCT00251316|87 patients were screened for the eligibility for this study. Total of 34 patients were enrolled into the study|The sample size for the trial is 100 patients and the goal for the number of patients to be randomized by November 2010 is 74 patients.
757290|NCT00251303||Subjects had to be symptomatic for at least 6 weeks, with a score of at least 20 CY-BOCS; had to have had at least one standard-of-care treatment for childhood OCD for adequate periods of time; had to have been stable for at least 6 weeks on any medicine; had to meet entrance criteria at a screening and 2 weeks later.
757291|NCT00251238||
757292|NCT00251225||
757293|NCT00251004||
757294|NCT00250926|Outpatient clinic at DFCI|Symptomatic patients with Waldenstrom's requiring therapy, previously untreated.
757295|NCT00250835|Subjects were recruited from participating cancer clinics across the state of New Mexico|
757296|NCT00250718||
757297|NCT00250705|Subjects were recruited through the child psychiatric clinic after being identified as diagnosed with DSM 4 conduct disorder. Subjects and their parents were approached about participation in the study. Recruitment time was November 2004 through March 2009|The study was an open label study with no separate treatment groups, i.e., different doses or placebo. All subjects that were enrolled into participation were entered into active treatment.
757298|NCT00250679||Two patients were each issued two randomization numbers; both subjects are included only once in the intent-to-treat (ITT) population. One additional subject was randomized in error and did not receive study drug. This subject is excluded from the ITT population.
757299|NCT00250588|Participants were recruited between June 11, 2004 and January 15, 2007. The final T3 follow up was completed on October 16, 2007.|
757300|NCT00250497||
757301|NCT00250484||Although 23 participants were recruited for the study, only 17 participated. This discrepancy is a result of 6 participants consenting for a realized exclusion criteria including a history of substance abuse or inability to commit.
757302|NCT00250458|"Twenty-Four (24) investigators in the United States
~Primary Therapy Period: MAR06 to OCT06."|Each patient was to treat one migraine attack of moderate or severe intensity with accompanying nausea. Rescue medication was allowed for headache non-response or recurrence after 2 hours postdose. Patients were to treat a qualifying migraine attack within 3 months after randomization.
757342|NCT00246805|enrollment period: from january 2006 till november 2008|
757303|NCT00250432|This was a Phase III study. The first patient was enrolled (FPE) on 13-Jan-2006. The last patient's last visit (LPLV) was on 13-Mar-2008. A total of 38 inpatient centers were involved in the recruitment worldwide (14 in the United States, 13 in the European Union, 7 in Central or South America, and 4 in Asia)|
757304|NCT00250276||
757305|NCT00249873|Patients were enrolled from June 2003 until May 2006. The study was conducted at 580 centers in 33 countries. The planned final follow-up visit date ensuring a median follow-up of three years was November 2008. The follow-up of the study was actually completed on March 2009 corresponding to an actual median follow-up of 3.5 years.|
757306|NCT00249834||A total of 166 subjects received at least 1 dose of recombinant human follicle stimulating hormone (r-hFSH). Of these, 161 subjects received r-hFSH in a dose group of 5 or more subjects. As per statistical analysis plan, only dose groups having 5 or more subjects were to be analyzed for efficacy and safety analysis in this study.
757307|NCT00249821||
757308|NCT00249808||
757309|NCT00249795|Patients were enrolled in 567 centers in 33 countries. They were initially to be followed until November 2008. After a blinded reassessment of the event rate in May 2008, the planned follow-up end date was postponed and was actually completed on August 2009 corresponding to an actual median follow-up of 4.5 years.|
757310|NCT00249769||
757311|NCT00249613|425 Potential subjects approached at community drug treatment clinics and drug courts 291 Completed baseline intake interview|At baseline, we had 51 Refusals, 30 Ineligible for study 27 No show to baseline interview, and 26 who did not complete baseline intake interview.
757312|NCT00249496||Participants (N=128) were enrolled in Phase 1 of the therapeutic workplace. Participants (N=51) who became abstinent and skilled were randomly assigned to an Abstinence & Employment (Contingency Management), or an Employment Only group.
757313|NCT00249470||56 completed the induction period and were randomly assigned to the two study groups.
757314|NCT00249444||There was a 2 week (no medication) lead-in period prior to randomization. To be randomized, patients had to attend at least 4 of 6 clinic visits, and submit at least 4 of 6 urine samples for toxicology during these two weeks. 86 participants were randomized.
757315|NCT00249379||
757316|NCT00249288|Forty six participants were enrolled; 38 completed screening and 32 received study drug.|
757317|NCT00249249|First Patient In: 4 October 2005 Last Patient Out: 8 November 2006 A total of 39 investigators at 39 sites in India, Russia, Spain and Denmark received IRB approval to participate in this study and screened and randomized patients.|Patients with major protocol violations were identified programmatically prior to unblinding to determine who should be excluded from the per protocol population.
757318|NCT00249002||
757319|NCT00248833|34 subjects were enrolled to be randomized into 1 of 3 cohorts at the WRAIR CTC.|
757320|NCT00248807|Recruitment has been completed.|All subjects recruited completed all testing procedures.
757321|NCT00248794|Veterans with schizophrenia or schizoaffective disorder who met the following inclusion were recruited between 2004 and 2008.|
757322|NCT00248781||
757323|NCT00248651|Study enrollment was during October 27, 2006 to February 11, 2013.|
757324|NCT00248638||
757325|NCT00248625|Participants were from an established registry of children with acute liver failure. Entry criteria: children <18 years, absence of a known chronic liver disease, biochemical evidence of acute liver injury, and a liver-based coagulopathy. Evidence of hepatic encephalopathy was required if the prothrombin time (PT) was between 15-19.9 seconds|
757326|NCT00248612|Following telephone screening (n=950), 162 eligible subjects completed an in-clinic baseline assessment #1 to determine eligibility for inclusion in the study.|Once subjects achieved the four day period of abstinence they completed a second baseline assessment in which eligibility was re-assessed. 81 Eligible subjects were then randomized into the four study arms.
757327|NCT00248560||
757328|NCT00248547|Inpatients receiving allogeneic bone marrow transplants who were to get either Busulfan/Cytoxan or Cytoxan/Total Body Radiation as conditioning regimen.|
757329|NCT00248534|patients enrolled from 2005 through 2008. Patients enrolled in an outpatient multi-institutional clinics|
757330|NCT00248495||
757331|NCT00248287||
757332|NCT00248170|Participants, who had recently undergone surgery, were randomly assigned in 1:1 ratio to letrozole or anastrozole. Participants received daily treatment until disease recurrence/relapse or for a maximum of 5 years. Participants underwent post-treatment long term follow-up for disease-free survival and overall survival.|
757333|NCT00248040|74 pt. (25 & 23 in reparixin continuous and intermittent infusion, and 26 in the pooled placebo) received the drug and were included in the safety population; 73 pt. (24, 23, 26) received both the study drug and the transplant and were included in the ITT. 1 started study drug but did not receive a kidney transplant, so was excluded from the ITT.|Six patients (2 in the reparixin continuous infusion group; 3 in the reparixin intermittent infusion group; 1 in the placebo intermittent infusion group) did not receive Investigational Product(s) or kidney transplants and hence they were excluded from both the Safety and ITT populations.
757334|NCT00247962|Subjects were recruited in multiple countries from December 2005 to September 2007.|Subjects were screened up to 4 weeks in a 2:1 randomization ratio.
757335|NCT00247728|215 patients were screened between June 2004 and December 2006. Patients were randomized in balanced blocks per center.|
757336|NCT00247676|This study was designed using a Simon 2-stage design with the objective response rate as the primary efficacy endpoint. Enrollment was halted after the first stage because the minimum number of responders by Response Evaluation Criteria in Solid Tumors (RECIST) needed to continue into Stage 2 was not reached.|
757337|NCT00247624||
757338|NCT00247611|HIV + patients were recruited via provider referral and notices about the study posted in five large HIV care clinics in Connecticut, USA.|
757339|NCT00247416||Total number of patients enrolled is 60. However, 1 patient enrolled to trial was discontinued from trial prior to receipt of any study therapies; patient was randomized to arm 1 (control, no dexamethasone pretreatment) but received no study therapies or procedures.
757340|NCT00247377|recruitment between 2002 and 2007 in our bariatric surgery clinic|Patients were excluded because they did not want to undergo the randomized assignment or inability to obtain insurance coverage for the operation
757343|NCT00246753|Men with castration-resistant prostate cancer were recruited from 3 local institutions from 11/11/2005 to 8/29/2007.|Of the 35 patients initially recruited, 4 were not eligible. One patient was removed in order to receive more aggressive treatment and another patient was removed due to disease progression or death prior to protocol therapy. 29 patients were enrolled.
757344|NCT00246740||
757345|NCT00246571||
757346|NCT00246519|Subjects were recruited to 3 sites, the University of Florida, Mayo Clinic in Rochester Minnesota, and Emory University. Subjects were seen in medical clinics by physicians and/or nurse coordinators. Patients were recruited from 2005-2010.|After enrollment subjects were currently on medication for blood pressure were required to wash out for a minimum of 2-4 weeks, at which point the blood pressure was reassessed for eligibility into the study. Of the 1701 subjects who enrolled in the study, 888 subjects met eligibility requirements to continue the study while 813 subjects did not.
757347|NCT00246441||
757348|NCT00246376|Subjects were recruited mainly from the Legacy Community Health Center and Thomas Street Clinic of the Harris County Hospital District and from Houston Area Community Services and private clinics. Recruitment period: January 2004 to September 2009.|If potential subjects were taking nutritional supplements or lipid-lowering drugs, these were discontinued for washout for 6 weeks - baseline fasting lipid levels were then measured to determine eligibility prior to randomization.
757349|NCT00246337|20 centers from the United States participated. First Patient treated on 01 December 2005; Last Patient Last Treatment was on 01 May 2006.|Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.
757350|NCT00246324||
757351|NCT00246259||
757352|NCT00246090|This study was recruited at 42 centers in US and 36 centers in EU during the period of Oct 2005 to Sep 2007.|
757353|NCT00246025||
757354|NCT00246012||
757355|NCT00245960|Subjects were recruited worldwide from December 2005 to September 2007.|Subjects were screened up to 4 weeks.
757356|NCT00245856|Recruitment period November 2002 to December 2008 OUHSC hospital and clinics: OU Medical Center and VA Medical Center|Consecutive patients, both inpatient and outpatient, who had objectively confirmed upper extremity DVT found on standardized comprehensive duplex imaging or venogram. Ineligibility : predefined ineligibility criteria including high risk of bleeding.
757357|NCT00245765|The study started to enroll patients in October 2005 and concluded in November 2006.|The study included a 12-week Treatment Period and a 12 to 24-week Follow-up Period. Participant Flow refers to the Intention-to-treat Set.
757358|NCT00245635||
757359|NCT00245583|Subjects were recruited primarily through community advertisements such as newspapers and targeted advertisements in casinos. Eligible participants were enrolled between October 26, 2005 and May 23, 2008.|Subjects were randomized in a 1:1 ratio to topiramate or placebo treatment. Following the baseline visit, participants underwent a 6-week titration period to 300mg/day or the maximum tolerated dose, followed by an 8-week maintenance. At the conclusion of the 14-weeks, study medication was tapered over a 7-day period.
757360|NCT00245570|"Patients were randomized at 5 sites (4 in the US and 1 in Peru).
~Primary therapy period: December 2005 to August 2006"|Patients who required excluded medications, or did not meet FEV1 criteria during the prestudy period were excluded from randomization.
757361|NCT00245557||
757362|NCT00245518||39 participants were enrolled in this study. 3 were not randomized due to failed screening on laboratory assessment, 2 because they withdrew due to personal reasons, and 1 because of dislike of the taste of the compound.
757363|NCT00245466|Participants who responded to degarelix in FE200486 CS02 (NCT00819247) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the UK or until the study was discontinued.|
757364|NCT00245219|Participants were recruited from local oncologists' offices. We contacted 915 eligible patients, of whom 245 provided informed consent and were randomized to an intervention group. The most frequently reported reasons for refusal were unwillingness/inability to drive to group meeting site (37.2%) and being too busy (29.4%).|
757365|NCT00245128||
757366|NCT00245102|Protocol Open to Accrual 09/09/2005 Protocol Closed to Accrual 07/22/2008 Primary Completion Date 03/22/2011 Recruitment Location is the medical clinic|
757367|NCT00245063||
757368|NCT00245050|Patients were recruited from the outpatient gynecologic oncology clinics at University Hospitals from May 2004 to December 2007.|Patients were required to have discontinued corticosteroid therapy at least three weeks prior to enrollment and no corticosteroids were allowed for the duration of the trial. Patients must have discontinued pyridoxine therapy at least three weeks prior to enrollment.
757369|NCT00245037||
757370|NCT00245011||
757371|NCT00244985||
757372|NCT00244933||
757373|NCT00244881|Participants were recruited at Dana-Farber/Harvard Cancer Center|
757374|NCT00244855||
757375|NCT00244764|This study was originally designed as a Phase II, multi-centre study utilizing a randomized discontinuation design. In the original study design, a 12-week Lead-in Phase was an open-label period during which all enrolled participans received pazopanib.|All participants began with 12 weeks of open-label treatment. In the original design, participants with stable disease at Week 12 were to be randomized. After the interim analysis, the study was amended to be treated like a single-arm open-label study. Any participants who had been randomized to placebo were to be crossed back to pazopanib.
757376|NCT00244751|The study was conducted in North America, Europe, and the International region. There were 22 study sites in Europe, 9 study sites in the International region and 45 study sites in North America. The study was conducted duration 02-November-2005 to 03-March-2008.|The study consisted of a pre-screening visit (within 60 days of first dose) and a screen visit. For this study, 110 sites screened 863 participants. Of these participants, 265 were randomized.
757377|NCT00244725|Male or female participants >=35 years of age with scheduled for primary elective unilateral total knee arthroplasty were recruited at 82 centers from 13 countries. The study was conducted between 28 September 2005 and 27 September 2006.|A total of 958 participants were randomized into the study. Two participants each from the treatment arm Odiparcil 250 milligram (mg), and Odiparcil 375 mg did not receive the study medication. Therefore, the intent to treat (ITT) population was comprised of 954 participants.
757378|NCT00244712|Participants were recruited at 76 study sites in the US and 2 study sites in Puerto Rico between 26 July 2005 and 16 June 2006.|After screening, participants who had never received treatment for HIV-1 infection and had a viral load greater than or equal to 1,000 copies per milliliter of blood and any amount of CD4+ T-cells were equally randomized to 1 of 2 treatment groups.
757379|NCT00244621|The study population included male and female participants 1 to <6 years of age with mild to moderate hypertension. The participants were recruited during the time period from 04 November 2004 to 07 August 2008 at pediatric clinics in the USA, Puerto Rico and Europe.|One to 2 weeks following a screening evaluation, participants underwent a 1-week, single-blind, placebo run-in period to reduce the variability in the baseline blood pressure measurements and to stabilize any concurrent antihypertensive medications.
757380|NCT00244374|Between 08/31/2004 and 11/30/2007, street-based outreach workers distributed study invitation cards to potential subjects in neighborhoods of San Francisco where young injection drug users (IDU) are known to congregate. Initial Contact form included self-reported age, IDU in last 30 days, hepatitis B immunization and HIV-positive status.|1304 persons completed initial contact form; 645 were eligible and 546 opted to participate in the cross-sectional study. The vaccine adherence cohort (n=167) included participants enrolled prior to 3/31/2007 who met additional eligibility criteria.
757381|NCT00244140|The recruitment period was 21 Oct 2005 to 11 Apr 2008.|437 subjects were screened; 2 subjects were screen failures because of not meeting inclusion criteria and/or meeting exclusion criteria; 435 subjects were enrolled; 1 enrolled subject withdrew consent before receiving study drug; 434 subjects received study drug and were included in the safety analysis set.
757382|NCT00244101||
757383|NCT00244010|Two patients and two donors were enrolled between 10/24/2005 and 2/24/2009 when the study was closed. The study was terminated due to the PI leaving St. Jude.|
757384|NCT00243932|Subjects were randomized between April, 2005 and May, 2007. The last participant completed the trial March 2008.|Exclusion criteria were forced vital capacity (FVC) of less than 60%, severe medical illness, or disease onset more than 5 years before study entry.
757385|NCT00243919|Participants were recruited from 6 inpatient rehabilitation centers in California and Florida from April 2006 through June 2009.|Participants admitted for inpatient rehabilitation were screened by chart review. Eligible participants with first-time stroke received a comprehensive medical record review and physical and cognitive screening. At 2-months, those who maintained eligibility and successfully completed an exercise tolerance test were enrolled.
757386|NCT00243841||This is a Phase I/II study. Phase I is a dose finding study, and Phase II will use the doses determined by the Phase I portion to further look at efficacy. During Phase I, it was determined to look at Childs A patients separately from Childs B patients. Patients who were Childs B required a dose reduction during Phase I.
757387|NCT00243659|Patients were recruited worldwide from April 2006 to April 2008.|Patients were screened for a maximum of 42 days.
757388|NCT00243503||
757389|NCT00243412|Approximately 40 subjects with moderately to severely active rheumatoid arthritis were to be enrolled at six to eight study centers in the United States and were randomly assigned in a 1:1 ratio to Arm A or B. Starting 15 August 2005 to 4 February 2009 (first subject enrolled to database lock).|All subjects were to receive rituximab 1000 mg * 2 on Days 1 and 15. Subsequently, subjects in Arm A received rituximab 500 mg * 2 every 6 months (Months 6, 12, and 18) and those in Arm B received rituximab 1000 mg * 2 at 12 months. To maintain the blind, subjects in Arm B received placebo infusions at Months 6 and 18.
757390|NCT00243386|Participants were enrolled at 21 European and 9 United States clinical sites beginning January 2006 and completing in June 2010|82 participants were enrolled and screened. 7 were screen failures, 1 was withdrawn for non-compliance, and 1 requested withdrawal. Therefore, 73 of the 82 enrolled were exposed to investigational product in the first part of the study (on-demand treatment).
757391|NCT00243347||
757392|NCT00243269|Patients were recruited at three cancer clinics from Feb. 6, 2006 to April 23, 2009|
757393|NCT00243243|Patients with greater than 20% TBSA burn scheduled for excision and grafting will be randomized in the operating room.|If the excision and grafting was not the first for the patient.
757394|NCT00243191|Recruitment period began May 1, 2006 and was completed July 22, 2009. There were 5 SARC sites participating. SARC sites are primarily academic institutions with Sarcoma programs.|
757395|NCT00243152|This study recruited adult males and females ages 18 to 60 with diagnosed facial neuropathic pain.|
757396|NCT00243074||
757397|NCT00243061||
757398|NCT00243022|Patients recruited from September 2004-September 2010 from local medical clinic.|
757399|NCT00242710||This main study also included osteoporosis substudy only for the purpose of the assessment of relevant parameters.
757400|NCT00242684|Of the 540 study eligible patients admitted to the TCU between March 2006 and March 2011, 446 (83%) entered the study.|
757401|NCT00242658||
757402|NCT00242632||
757403|NCT00242619||
757404|NCT00242580|The protocol was amended to limit the sample size from 339 to 100. 111 entered the study and and were part of the 12 mo analysis. The study was subsequently terminated. The patients did not receive study drug during the second year of the study.|
757405|NCT00242567|552 patients enrolled, but 30 patients were excluded due to GCP issues in one country.|
757406|NCT00242502|Recruitment Period: September 30, 2005 to May 12, 2009. All recruitment done at UT MD Anderson Cancer Center.|Of the 62 participants, three (3) were excluded prior to treatment and are excluded from the trial.
757407|NCT00242385|Enrollment was conducted at seven clinical sites in Australia (4 sites) and New Zealand (3 sites) beginning in December 2005.|All 25 enrolled subjects were assigned to groups.
757408|NCT00242216|Patients enrolled at a county clinic|
757409|NCT00241969||
757410|NCT00241904||
757438|NCT00239226|Enrollment: november 2005 - may 2008 Sites:Ospedale P. Cosma Camposampiero-Ospedale Civile ULSS 13 Mirano-Ospdale Civile,Como-Ospedale Cisanello,Pisa-CRN,Pisa-Ospedale civile, Livorno-Ospedale Molinette, Torino-Presidi Ospedalieri Riuniti,Borgomanero-Ospedale San Pietro Igneo, Fucecchio-Azienda Ospedaliera di Desenzano del Garda Desenzano|
757439|NCT00239005|In total, 135 patients were screened. One patient was not randomized due to an SAE prior to the randomization visit. Out of 134 randomized patients, 5 withdrew before taking study drug. Analysis population: 68 in EC-MPS, 61 in MMF.|
757411|NCT00241839|Recruitment was through flyers and voluntary blood pressure checks and hypertension lectures throughout the county in churches, health fairs, community art festivals, new business openings and celebrations, and in hospital lobbies, business employee lounges, store front spaces at grocery stores and super stores. Individuals also self-refered.|150 subjects signed consents;8 were withdrawn prior to randomization. All participants were placed on chlorthalidone 25mg daily for blood pressure stabilization along with potassium chloride (KCL) 40meq daily. Potassium chloride was increased to 50meq daily for those subjects whose serum potassium was less than 3.5 before baseline visit.
757412|NCT00241644|Only subjects from Malawi and from Cohort 2 South Africa were asked to continue the study for a second follow-up period (Year 2).|"Of the total of 4941 subjects enrolled in this study, 2 subjects were allocated a subject number but did not get any study vaccine administered. Hence, only 4939 subjects were considered as 'started'.
~For the second follow-up period, as mentioned in the protocol the results are presented for Rotarix Pooled and Placebo Groups only."
757413|NCT00241631||
757414|NCT00241358|The study was opened to participant enrollment on 05/14/2004 and closed to participant enrollment on 01/26/2009.|
757415|NCT00241280||504 Subjects were enrolled in this study. 1 subject did not meet the eligibility. 2 subjects were randomized to the control lens group, but were not dispensed lenses. 247 subjects were randomized to the Control lens and 254 subjects were randomized to the Test lens.
757416|NCT00241176||
757417|NCT00240994|Four centers in the United States recruited 35 subjects between January 2005 and October 2007 who were less than 21 years of age and first time living-donor kidney allograft recipients.|At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form.
757418|NCT00240981|All participants provided written, informed consent. Recruitment took place at VAHCS, NERI, and BUMC. Outcome assessments were performed at BUMC. The study consisted of a 24- week intervention followed by a 12-week observation period. Enrollment took place between September 2005 and December 2009.|The participants were community-dwelling men, aged 65 years and older, with total testosterone between 100 and 350 ng/dL or free testosterone less than 50 pg/mL, and mobility limitation.
757419|NCT00240539||"Participant Flow and Baseline measures are given for the year 20 time point in order to account for all subjects participating in this long-term follow-up study.
~Note that not all subjects returned and participated in each of the intermediate follow-up time points."
757420|NCT00240526||The baseline characteristics are given for the Year 15 time point. Therefore the number of participants in the Engerix-3D Group is 21, as in the Year 15 participant flow data.
757421|NCT00240500||
757422|NCT00240487|Patients were recruited from the Pediatric Intensive Care Unit from 2000-2008.|
757423|NCT00240331|Recruited patients were male or female with end-stage renal failure aged 50 to 80 years, who had received regular chronic haemodialysis treatment (including haemofiltration and hemodiafiltration ) for at least 3 months. They were recruited from 280 sites in 25 countries; recruitment started on 16 January 2003 and finished on 24 November 2004.|After a two week screening period, eligible patients were randomly assigned to either rosuvastatin treatment (10mg/day) or placebo with a 1:1 randomisation ratio. Follow-up was planned to continue until the accrual of 805 major cardiovascular events
757424|NCT00240227||Participants were randomized to one of two sequences, either placebo first or prazosin first. However, the precise numbers of which sequence participants were randomized to are no longer available considering the time (7 years) since the study was completed.
757425|NCT00240162|The study opened to participant enrollment on 09/21/2005 and closed to participant enrollment on 06/17/2008.|
757426|NCT00240110||High screen failure for not meeting inclusion/exclusion criteria and for lost to follow-up during screening
757427|NCT00240097||
757428|NCT00240071|Recruitment started October 2005 - until March 2009. Kirklin Clinic at University of Alabama at Birmingham (UAB), Birmingham, Alabama (AL) and Georgia Cancer Center, Atlanta, Georgia (GA)|The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin.
757429|NCT00239928||All subjects received a 0.3 mg or 1 mg/eye EYE001 (pegaptanib sodium) intravitreal injection every 6 weeks for 48 weeks in the preceding study A5751010 (NCT00150202)
757430|NCT00239837|Child welfare staff members referred girls to the study between 2003-2006, by searching their database to gather information on all girls who were 10-12 years old, in their final year of elementary school, currently in foster care, and living in the targeted counties in Oregon.|
757431|NCT00239733||
757432|NCT00239720|Two centers in the United States enrolled four participants between March 2006 and September 2006 who had psoriatic arthritis with three or more active joints despite ongoing therapy with methotrexate or azathioprine|At screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form
757433|NCT00239681|The first subject was enrolled on 05 February 2003. The last subject completed on 20 August 2008. Study subjects were randomized at 1348 centers in 26 countries. Enrolled subjects participated in an initial 4-week, run-in phase and received placebo therapy.|If found eligible for the main study on the basis of appropriate levels of baseline Low Density Lipoprotein (LDL), High-sensitivity C-Reactive Protein (hsCRP), and run-in phase compliance (>80% of pills taken), subjects were randomized to either rosuvastatin 20 mg or placebo once daily
757434|NCT00239642|Hospitals and Medical Clinics; Study Period - October 24, 2005 through January 23, 2009|Stable erythropoietin (EPO) dose (±25% of current dose) for 8 weeks prior to the qualifying screening visit.
757435|NCT00239590|Outpatients at a tertiary referral NHS hospital in London, UK. Eligible patients were invited to participate by post. Interested participants returned an eligibility questionnaire. Those fulfilling the inclusion/exclusion criteria were invited to attend for a screening/consent appointment.|Blood was taken at a screening visit. Those not fulfulling the inclusion/exclusion criterial were excluded.
757436|NCT00239577||
757437|NCT00239356|This study continued to provide aripiprazole post-study to schizophrenic and bipolar I disorder outpatients who had received aripiprazole on other Bristol-Myers Squibb Company (BMS)-sponsored clinical trials.|119 enrolled, 117 treated. Reason(s) for not treated: 2 participants withdrew consent prior to treatment.
757440|NCT00238615||
757441|NCT00238433||
757442|NCT00238420||After patient registration, sites submitted tissue to central her2/neu evaluation. If tissue was evaluable and a patient continued on study, then treatment arm was assigned. Seventy-six patients were registered and 6 did not continue to treatment assignment: 2 patient withdrawal, 2 protocol violation, 1 progressive disease, 1 institutional error.
757443|NCT00238355||
757444|NCT00238303|Participants were recruited from 24 medical clinics in the United States between September 2005 to May 2008.|
757445|NCT00238264||
757446|NCT00238238|Between October 2006 and April 2011, 97 participants were accrued to the study.|Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.
757447|NCT00238121|The study population consisted of patients at least 18 years old with advanced or recurrent carcinoma, or uterine carcinosarcoma. Both cohorts received a starting dose of 400 mg sorafenib orally twice daily on a continuous basis.|A Simon optimal two-stage design was used with objective response rate as the primary efficacy endpoint.
757448|NCT00238108||
757449|NCT00237809|Subjects were enrolled between 2003 and 2008, with enrollment of subjects in India starting later (2005) and ending in 2008.|132 subjects were screened for eligibility. After screening, eligible subjects were randomized to receive: D-serine+CRT, placebo D-serine+CRT, D-serine + control CRT, or placebo D-serine + control CRT. Randomization was stratified by screening performance IQ. Separate randomization schedules (block size= 4) were generated within IQ stratum.
757450|NCT00237796|Participants included 79 middle age and older community dwelling Veteran and non-veterans. Inclusion criteria: diagnosis of schizophrenia or schizoaffective, age 45 or older, and fluency in English. Exclusion criteria: prior exposure to CBT during the previous five years.|"Baseline data were collected before randomization. N=116 participants enrolled in the study and N=79 started.
~Total of 37 excluded for reasons: n=20 lost interest; n=6 wrong diagnosis, n=3 not psychiatrically stable; n=3 not medically stable, and n=5 lost contact/moved."
757451|NCT00237770|Recruitment occured from January 2006 through May 2009; participants were recruited from the James J Peters VA Medical Center and the surrounding community.|No subject was excluded after enrollment prior to participation.
757452|NCT00237744|Subjects were recruited by word of mouth and from an advertisement flyer.|
757453|NCT00237718|This study was conducted at the Vanderbilt University Medical Center and at Fresenius Medical Care North America Dialysis clinics between April 2006 and September 2010.|There is a 1-month period between enrollment and assignment to a treatment group. Although 385 subjects were enrolled, only 356 were randomized (29 subjects withdrew consent prior to randomization). Also, 31 subjects were administratively withdrawn (due to widespread protocol non-compliance at one site) leaving 325 subjects assigned to a group.
757454|NCT00237692||
757455|NCT00237666|The trial was conducted at three research centers, located in: New York, NY; Plano, TX; and Seattle, WA. Subjects were recruited over a 37 month period.|The planned and actual study population was 30 patients, 18 years of age or older, who met DSM-IV criteria for bipolar II disorder with a history of at least one hypomanic episode.
757456|NCT00237458|The study started in May 2001 with subjects from Germany. The primary completion date and study completion date occurred in March 2011.|One subject was discontinued on the study due to the Adverse Event of Vertigo. However, the Termination page of the Case Report Form reflected that the subject withdrew consent. Therefore, the Participant Flow will reflect 3 subjects did not complete the study, while the subjects withdrawing from Adverse Events will reflect 2.
757457|NCT00237185||
757458|NCT00237042|Recruited 10/05-06/09. Study participants were recruited from patients seeking care at the University of Washington Orofacial Pain Clinic and by advertising.|Run-in period: Study participants completed daily diaries of pain and other symptoms for one menstrual cycle prior to randomization. Only participants who returned completed diaries for at least 85% of the requested days were eligible for randomization. 191/252 enrolled subjects were randomized.
757459|NCT00236977|Recruitment period: August 2003 to October 2004. Locations: Hospitals, Medical Clinics|Eligibility requirements: Serum Transferrin Saturation (TSAT) <= to 25%, Ferritin <= to 300 ng/mL, and no iron following enrollment. At randomization subjects were stratified by gender, hemoglobin (Hgb) levels (< or = to 9.0 g/dL, 9.1 - 10.0 g/dL, 10.1 - 11.0 g/dL), and erythropoietin use.
757460|NCT00236951|July 18, 2003 - October 27, 2005 Locations: Hospitals and Medical Clinics (33 total sites)|Anemia defined as a hemoglobin level < or = to 10.0 g/dL.
757461|NCT00236938|Recruitment Period: July 29, 2002 - September 6, 2004 Locations: Hospitals and Medical Clinics|
757462|NCT00236899||
757463|NCT00236197|This study was recruited at 38 centers in the US during the period of 13-Oct-2005 and 21-Mar-2006.|The screening phase (1 to 2 weeks) included a 1-week single-blind placebo run-in phase in order to determine baseline heartburn frequency and diary compliance. At the end of the run-in phase, subjects continued the study and entered the randomized treatment phase if they meet the study criteria.
757464|NCT00236184|This study was recruited at 39 centers in the US during the period of 10-Oct-2005 and 16-Mar-2006.|The screening phase (1 to 2 weeks) included a 1-week single-blind placebo run-in phase in order to determine baseline heartburn frequency and diary compliance. At the end of the run-in phase, subjects continued the study and entered the randomized treatment phase if they meet the study criteria.
757465|NCT00236080|16 centers in the US. First participant enrolled: 7 September 2005/ Last participant last visit: 1 December 2005|2 male participants withdrew after randomization but prior to receiving study drug (1 for noncompliance and 1 at the request of the sponsor)
757466|NCT00235989|Eligible patients for this multi-center study included only those who completed in a predecessor study. Patients were enrolled at the end of the preceding study, from 03 Jun 2003 until 06 Jun 2003. Patients who interrupted study medication in accordance with the investigator were eligible, provided it did not result in premature End of Study (EOS).|For the first 10 weeks of this extension study, patients remained on the IFNB-1b dosage assigned in Study 307000A (Core Treatment). At the Week 10 visit, patients were unblinded by the sponsor and given a choice of drug dosage. They could continue on the original doses, 250 or 500 micrograms, or could change to the other dose (Extension Treatment).
757467|NCT00235872||
757468|NCT00235833|Japanese subjects with moderate to severe rheumatoid arthritis (RA) in relatively good physical health excluding RA symptoms and who completed a preceding continuous repeated administration study of adalimumab (DE035X/D2E7-J081-003) who wished to continue treatment until approval of adalimumab in Japan.|
757469|NCT00235755||Participants who completed the Double-blind Phase (Titration plus Maintenance Phases) who elected to continue in the Open-Label Extension Study (OLE-S) entered the Transition Phase, for titration, if on placebo, or to maintain the blind if on retigabine. Participants who did not enter the Titration Phase entered a Taper Phase.
757470|NCT00235716|Recruitment initiated in August, 2007 and concluded in March, 2012. Enrollment took place at 14 VA medical centers.|
757471|NCT00235573|Subjects were recruited from the Gainesville/Alachua county area through newspaper ads, email, and flyers posted on the UF campus. Flyers also were given to individuals or groups. Respondents were interviewed by telephone and asked questions to ascertain if they met inclusion criteria. Individuals meeting criteria were screened for B12 status.|Individuals with a normal general blood chemistry profile, no history of chronic disease and normal CBC and vitamin B12 status were eligible to participate in the study. Those with deficient serum B12 levels were instructed to follow up with their personal physician. Subjects who met all inclusion criteria received the same treatment.
757472|NCT00235547||
757473|NCT00235495||
757474|NCT00235456||
757475|NCT00235443|Trial SP745 (NCT00235443) was conducted in 93 sites in the US and 89 of these sites screened at least 1 subject. The first subject was enrolled on 13Sep2004 and the last subject completed on 25Jul2008.|
757476|NCT00235391||
757477|NCT00235326|Residents of Walkerton in may 2000|Age less than 16, non-residents of walkerton, premorbid Inflammatory Bowel disease(IBD) /Irritable bowel syndrome(IBS)
757478|NCT00234884||
757479|NCT00234832||Of the 10777 subjects enrolled into the study, 33 were not treated with Lead-in Period sibutramine. Of the 10744 subjects who took at least 1 dose of Lead-in Period sibutramine, 939 were not randomized. One of the remaining 9805 subjects was not dispensed randomized study drug and was not included in the intent-to-treat population (N = 9804).
757480|NCT00234533|251 children presenting growth failure associated with Growth Hormone Deficiency (GHD), Turner Syndrome (TS) or Chronic Renal Insufficiency (CRI) were screened (with informed consent) in 46 study centers across Europe. First patient enrolled: 7 June 2004; last subject completed: 22 July 2008|Of the 251 children screened 3 did not receive study medication, 1 due to withdrawal of consent, 1 did not meet screening criteria for height and 1 was not included due to the investigator's decision.
757481|NCT00234494||
757482|NCT00234286|The BEACON trial implemented an intervention to improve quality of care at end of life. Six Veterans Administration Hospitals received the intervention in a pre-post design. Outcomes were abstracted for 6066 individuals who died either pre or post intervention. 78 next-of-kin were enrolled under protocol to conduct qualitative interviews.|The BEACON trial implemented an intervention to improve quality of care at end of life. Six Veterans Administration Hospitals received the intervention in a pre-post design. Outcomes were abstracted for 6066 individuals who died either pre or post intervention. 78 next-of-kin were enrolled under protocol to conduct qualitative interviews.
757483|NCT00234104||
757484|NCT00234078||
757485|NCT00234065|Patients with non-cardioembolic ischemic stroke have been recruited at 278 study sites in Japan between December, 2003, and October, 2006.|No screening period
757486|NCT00234052|The study opened for accrual on June 1, 2005 with an accrual goal of 50 patients. The first patient enrolled started treatment on July 28, 2005. The study was closed permanently on July 10, 2007 when accrual had been met with 51 patients registered and 50 patients treated on study.|
757487|NCT00234039||
757488|NCT00233987||
757489|NCT00233948||
757490|NCT00233519||
757491|NCT00233480||
757492|NCT00233454||
757493|NCT00233402|A total of 814 patients were included in the study at 28 medical centers in the USA, Canada and Europe between January 2005 and September 2007.|
757494|NCT00233324|3546 infants assessed for eligibility from 3127 pregnancies. 2230 were excluded for not meeting eligibility criteria or parental permission was not granted or other reasons.|235 did not meet eligiblity criteria 125 did not have personnel or equipment available 699 were eligible did not have consent sought 344 were eligible but parent or guardian was not available 748 were eligible but parent or guardian denied permission to enroll 68 were eligible and had permission but were not randomized 11 had other reasons
757495|NCT00233103|Participants were recruited through physician referrals and flyers posted in outpatient rehabilitation treatment areas and distributed at TBI-survivor groups. Participants from past research projects who had agreed to be contacted for future studies were contacted.|
757496|NCT00233090||
757497|NCT00233064|A total of 417 subjects were randomized into the study at 51 sites in the United States between 20 October 2005 and 02 October 2007.|A total of 4 subjects at site #1022 who received all 5 doses of study drug (per drug accountability records) had no further information including case report form that could be obtained. These 4 subjects were excluded from all data analyses.
757498|NCT00232739||
757499|NCT00232596||Participants who completed the Double-blind Phase (Titration plus Maintenance Phases) who elected to continue in the Open-Label Extension Study (OLE-S) entered the Transition Phase, for titration, if on placebo, or to maintain the blind if on retigabine. Participants who did not enter the Titration Phase entered a Taper Phase.
757500|NCT00232583|Patients recruited at UT Southwestern Clinical Diabetes Research Office|A 3-months run-in period preceeded randomization. During this period all patients were treated with insulin and metformin.
757501|NCT00232557||
757502|NCT00232544||
757503|NCT00232505|Subjects were recruited between December 2005 and October 2007 from thirteen cancer centers throughout the US.|Four patients declined participation for personal reasons, three were screen failures, three had death or progression during the screening period.
757504|NCT00232479||
757505|NCT00232180||A total of 1597 participants who completed the double-blind phase, 1246 entered into the open-label phase and 351 participants were ineligible to participate the open-label phase.
757506|NCT00232141|43 centers in the United States; Study Initiation and Completion Dates: 6 October 2005 to 27 November 2007|A total of 472 subjects were screened for the study, and 302 subjects were randomized to study treatment.
757507|NCT00231894|Recruitment at 6 U.S. sites and one site in Shanghai, China|
757508|NCT00231868||
757548|NCT00227721||
757509|NCT00231842|Eligible participants with surgically staged I-IV uterine carcinosarcoma (CS) without evidence of gross residual disease after primary surgery were recruited from 1999 to 2009 . Eligible participants underwent surgical staging when clinically indicated.|30 participants were enrolled and 3 participants withdrew prior to therapy. Twenty-seven participants received the first three cycles of chemotherapy and Radiation Therapy and were included in the analysis.
757510|NCT00231816|"Participants were recruited at 13 sites in the United States and 7 sites in Europe.
~First Patient In (FPI): 23-SEP-2005; Last Patient Last Visit (LPLV): 08-MAR-2006"|
757511|NCT00231777|First Patient In: 02-Aug-2005; Last Patient Out: 29-Nov-2005; 15 study centers in the US|Patient is at least 18 years of age and is scheduled to undergo open abdominal surgery or vaginal hysterectomy requiring overnight hospital stay (24-hour hospital stay after end of surgery).
757512|NCT00231478||
757513|NCT00231465||
757514|NCT00231413||
757515|NCT00231309|10 patients were enrolled between July 2003 and March 2006. Patients were enrolled during consent visits for upcoming bone marrow transplants.|Patients were not excluded before assignment to groups.
757516|NCT00231283|First patient enrolled was Apr 2004 and last patient enrolled was Jul 2004.|
757517|NCT00231179|Participants were recruited from the Hospital of the University of Pennsylvania after giving birth to a healthy singleton newborn infant, if they lived in pre-identified ZIP Code areas of Philadelphia. Participants were recruited from July 6, 2001 through January 7, 2002. 302 mothers were enrolled and 254 completed the 5-year follow-up visit.|Randomization occurred at enrollment. At the time of follow-up, participants continued to remain in the originally assigned group of either control or intervention.
757518|NCT00231153|A total of 1859 hospitalized patients in the US and EU who required new insertion of short-term central venous catheter were enrolled. Study recruitment began in August 2005 and was completed in April 2008.|Patients were randomized within 4 hours of insertion of the first study CVC. There were a total of 44 patients who were randomized but never received insertion of CVC or exposure to assigned treatment, who were excluded from the evaluable population and were not reviewed by the Evaluation Committee.
757519|NCT00231114||
757520|NCT00231062|Recruited from 3/2005 to 12/2005 in physician practice|
757521|NCT00230971|Patients were recruited worldwide from November 2005 to July 2008.|Patients were screened according to the inclusion/exclusion criteria. Once informed consent was obtained, the patient was enrolled into the study and assigned a randomization number and a treatment regimen.
757522|NCT00230802||
757523|NCT00230737||
757524|NCT00230282||
757525|NCT00230178||
757526|NCT00230126||
757527|NCT00230100|Patients with current substance dependence were recruited from McLean Hospital programs, advertisements, flyers, and clinician referrals. Advertisements were for investigational group therapy for substance abuse but did not specify the Women's Recovery Group in order to minimize selection bias for women only interested in women's treatment.|Groups were conducted in an semi-open format where enrollment continued until a maximum of 6-8 subjects were entered per group and then enrollment was closed until the end of the sequence.
757528|NCT00230048||
757529|NCT00230022||
757530|NCT00230009|Participants for this phase were recruited from a large prenatal care clinic affiliated with Wayne State University. Participants were either (a) approached while in the waiting area, or (b) identified via a participant database as being willing to be contacted regarding research studies.|
757531|NCT00229970|"Phase III.
~Studied period: September 12, 2005 (date study drug was first administered to first patient) to October 23, 2006 (date study drug was last administered to last patient). Study was conducted at 64 clinical sites."|Patients with acute exacerbation of bronchial asthma received standard treatments of inhaled β-agonist or oxygen inhalation to treat the acute exacerbations during the 60 minutes in the screening period before the study randomization.
757532|NCT00229957|All participants recruited from a family health practice.|
757533|NCT00229931||
757534|NCT00229723|In total, 226 patients from 26 centres in 8 countries were randomized to receive study medication, the first patient was enrolled into the study on 13 November 2004 and the last patient completed the study on 27 June 2008. Patients were to be followed up for a maximum of two years (± 12 weeks) after randomization.|
757535|NCT00229658||
757536|NCT00229619||
757537|NCT00229203|Patients were recruited in 10 centers in Spain and USA between June 2004 and June 2008.|
757538|NCT00228943|Subjects were recruited from a Midwestern outpatient cancer clinic from 2005 to 2007.|260 women were screened, 39 of whom were not interested, 162 were found ineligible.
757539|NCT00228917||
757540|NCT00228813|Participants were recruited from Children's Healthcare of Atlanta between January 2005 and December 2013.|
757541|NCT00228566|40 centers in the US. First participant enrolled: 5 October 2005. Last participant last visit: 27 July 2006|1 female participant withdrew for noncompliance after randomization but prior to receiving study drug. The number of participants then analyzed (241) by a PGI-C rating was defined to be those participants who took at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment (5 patients did not meet this requirement).
757542|NCT00228553|99 centers in the US, Canada, France, Germany, Russia, and Australia. First participant enrolled: 15 May 2004/ Last participant last visit: 19 July 2006|12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug
757543|NCT00228384||
757544|NCT00227994|40 participants received study medication|
757545|NCT00227903|Recruitment occurred between June 2006 and September 2009, with follow-up concluding in July 2010. Women were screened and recruited while attending obstetrical appointments in two hospital-based reproductive health clinics in New Haven and Bridgeport, CT.|13 women who were consented to the trial and provisionally were found to be eligible either declined or failed to complete intake, 1 had an incomplete intake and 1 was found to be ineligible at intake
757546|NCT00227877|Quasi-experimental, asynchronous study design with each site as its own control. From 2005 to 2008, 12- to 18-year-olds arriving for routine care at 9 medical offices in New England (n= 2096, 58% females) and 10 in Prague, Czech Republic (n = 589, 47% females) were recruited. Medically/emotionally stable, able to read, and available for follow-ups.|
757547|NCT00227760||
757549|NCT00227617||Simon 2-stage design: 13 patients in stage 1. If at least 2 objective tumor responses were observed by 12 cycles of therapy, the cohort was to be expanded to enroll a total of 39 treated patients.
757550|NCT00227591|This study accrued 48 cases between December 2, 2005 and March 9, 2007. Per two-stage design, the study was suspended on May 31, 2006 for a toxicity and response analysis. Since more than 4 patients achieved a response, the study was reactivated on December 5, 2006. Accrual continued to a total of 48 patients and terminated on March 9, 2007.|
757551|NCT00227539||
757552|NCT00227370|Prospective subjects were screened and enrolled from July 2003 - January 2007 at 11 US lung transplant centers. 189 subjects were screened and 157 met inclusion criteria and were therefore enrolled in the study.|Upon receipt of a lung transplant, enrolled subjects received 90 days of valganciclovir for CMV prophylaxis, per standard of care, and then were randomly assigned, 1:1, in a double blind fashion, to either the extended prophylaxis group (9 additional months of standard of care dosing Valganciclovir, adjusted for renal function) or placebo group.
757553|NCT00227344|One hundred twenty-nine (129) subjects were enrolled in the study at the time of termination. Ten of 13 study sites were in Italy, thus the majority of subjects were recruited from Italian sites. The sponsor's decision at study termination was to report primary and secondary endpoints for which meaningful data analysis was possible.|
757554|NCT00227305|Enrollment was contingent on completing one of 2 short term efficacy studies, recruitment period August 2004 through July 2007 at 59 international clinical research sites|Required to have completed one feeder study, either bipolar mania study D1441C00149 or schizophrenia study D1441C00112 and be willing to participate in a 26 week open label study and be between the ages of 10 and 18 years at the time of consent for this study, initial titration to maintain blind in feeder study
757555|NCT00227266|Subject's were recruited during the periods of September 2005 to September 2006 across the United States.|
757556|NCT00227019||
757557|NCT00226941||
757558|NCT00226811||This study used a Simon 2-stage design with objective response rate (ORR) as the primary efficacy endpoint. Enrollment was halted after Part 1 Stage 2 because the minimum number of responding subjects required to proceed to Part 2 was not reached. Further subject enrollment therefore ended after 78 subjects had been enrolled and treated on Part 1.
757559|NCT00226655|Recruitment started February 2005;|Patients rolled-over from previous placebo controlled studies; open label study so no group assignment
757560|NCT00226590||
757561|NCT00226577||
757562|NCT00226499||
757563|NCT00226239||
757564|NCT00225784|This was a single-institution study of weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with pancreatic ductal adenocarcinoma conducted at Dartmouth-Hitchcock.|
757565|NCT00225758||Subjects will continue on the same endocrine therapy they had been taking at the time of disease progression.
757566|NCT00225732|Participants were recruited from the medical practices and/or clinics of the investigator/sub-investigators.|A total of 319 participants were randomized into two treatment groups. Randomized participants were additionally stratified by age and weight; three participants were randomized to incorrect stratification categories. All 319 participants received at least one dose of clinical trial material.
757567|NCT00225498|10 schizophrenia patients who met nonresponse criteria|The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.
757568|NCT00225420|Subjects with high-risk or locally advanced prostate cancer were recruited from 2 institutions between December 2005 and January 2010.|Two patients were taken off the study due illness, two were removed because they were too large for the equipment, and one was removed due to CT screen failure.18 men with high-risk or locally advanced prostate cancer were enrolled. All 18 patients completed their radiation therapy and 16 completed all planned chemotherapy doses.
757569|NCT00225277|Subjects were enrolled at 97 sites in the United States, Canada, Argentina and Chile from 21 July 2003 to 18 October 2007.|The participant flow results below do not include 4 subjects who were randomized but did not receive drug. Subjects participating in this study were enrolled in Pioglitazone or Glimepiride once daily (QD) treatment group.
757570|NCT00225251||
757571|NCT00225212||
757572|NCT00225147|"During the double-blind phase of the study, patients were randomized once to receive 100 IU/kg rhC1INH, 50 IU/kg rhC1INH or Saline in a ratio of 1:1:1. After treatment in the double-blind phase, patients with subsequent eligible attacks could be treated with open-label 50 IU/kg rhC1INH."|Patients could be enrolled into the open-label phase of the study after treatment in the double-blind phase of the study, including those enrolled but not treated in the double-blind phase.
757573|NCT00225017|Recruitment period June 2005 to November 2007 at four clinics in the United States, one in Italy, and one in Argentina|
757574|NCT00224952||
757575|NCT00224874|Clinic patients were recruited from August 2005 through March 2008.|
757576|NCT00224770|110 patients were randomized to the trial, and 31 were recruited as pilot patients.|Each study center was required to demonstrate proficiency in the technical aspects of enrollment, stabilization, surgery, and drug administration. This proficiency was demonstrated on at least one pilot patient prior to randomization of the first patient in the investigational cohort of 110 randomized patients.
757577|NCT00224484||
757578|NCT00224289||
757579|NCT00224133||
757580|NCT00224120||
757581|NCT00224107||
757582|NCT00224055||
757583|NCT00224042||
757584|NCT00224029||washout of previous anticholinergic therapy during the screening period
757585|NCT00224016||
757586|NCT00224003||
757587|NCT00223990|Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine) at the Walter Reed Project Kombewa Clinic in Kombewa Division, Kisumu District, Nyanze Province, Western Kenya (and 12 small field stations within Kombewa Division).|
757588|NCT00223977||
758434|NCT00131469||One participant was formally enrolled but then dropped out before the first study treatment was administered.
757589|NCT00223821|Participants were community-dwelling women with urge predominant incontinence recruited between July 2003 and January 2008.|Of the 166 women enrolled, 58 were found to be ineligible on clinical evaluation, 44 withdrew, and 64 were randomized.
757590|NCT00223808|Enrollment: November 2002 - December 2004 Enrollment sites: Michael E. DeBakey VA Medical Center, Houston, TX; VA Greater Los Angeles Healthcare System, Los Angeles, CA; and VA Palo Alto Health Care System, Palo Alto, CA. Data analysis site: Central Texas Veterans Health Care System, Temple, TX.|4 subjects excluded from group assignment due to medical conditions that precluded moderate-workload exercise.
757591|NCT00223795|Subjects were recruited 2005-2008from the outpatient clinics of the VA West Los Angeles Healthcare Center, an urban tertiary academic hospital.|
757592|NCT00223704|Patients were enrolled by the research nurse at the time of the preoperative evaluation for surgery. All patients provided written informed consent. The study period was from June 2007 until June 2012.|One hundred and fifty patients consented to participate in the study. Of these patients, 13 were excluded,12 withdrew before randomization, 4 had their surgeries canceled, 3 had their surgery dates changed, and 3 patients did not proceed with the study for other reasons. The remaining 115 patients were randomly assigned to one of three groups.
757593|NCT00223678||
757594|NCT00223665|The target population for this trial was men with localized prostate cancer who had a rising PSA after definitive therapy (radiation therapy, brachytherapy, or radical prostatectomy). Patients were enrolled from Jan 1997 through Sept 2006 at the University of Washington and the Seattle Cancer Care Alliance.|
757595|NCT00223652||
757596|NCT00223496|Recruitment from March 2006 to June 2009 from clinic patients and those responding to public advertisements.|Subjects who entered study in a bipolar depressed state were started on divalproex ER. Those still depressed, according to depression rating scales, after visit 4 were given aripiprazole in addition to divalproex ER.
757597|NCT00223262||
757598|NCT00223236|Patients were recruited from local community behavioral healthcare clinics and through advertising in local publications. The recruitment period was from 5/1/2004 to 4/12/2005.|Participants were randomized to medication assignment after meeting the inclusion and exclusion criteria and completing the Institutional Review Board(IRB)-approved informed consent process.
757599|NCT00223080|16,402 subjects were randomized, 16,395 were infection free and assigned treatment groups|16,402 individuals were randomly assigned to the 2 treatment arms. 7 individuals were identified as having human immunodeficiency virus (HIV) infection that was present pre-vaccination detected by polymerase chain reaction (PCR) amplification. These individuals were removed from the modified intent to treat (MITT) population.
757600|NCT00222729||
757601|NCT00222131||
757602|NCT00222105||
757603|NCT00221403||
757604|NCT00221338||
757605|NCT00221299||
757606|NCT00221195|The study was conducted at 16 hemophilia treatment centers in Europe and the United States.|Patients were randomized to one of two 6 month treatment periods. Following the initial treatment period each subject had a 3 month wash-out period during which time they used on-demand therapy to treat bleeding. Following the 3 month wash-out period each patient was crossed-over to the other 6 month treatment period.
757607|NCT00221117|Subjects were randomized using 2 sets of sealed envelopes. Each unmarked envelope contained a single sheet of paper with a printed number in the range of 1 to 40. A second set of envelopes was marked with numbers from 1 to 40 and contained a single sheet specifying the group allocation.|If participant did not meet inclusion criteria they would be excluded
757608|NCT00221104|Participants were enrolled from March 2004 and February 2009 recruited at 123 clinical sites in Japan|Participants were randomly assigned to the pravastatin group or the control with 1:1 allocation rate. The patient allocation was dynamically balanced with the stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence) between the two groups.
757609|NCT00220961||
757610|NCT00220805|A total of 96 subjects were enrolled (signed the informed consent and screened) in this study at 6 German study centers.|Of the 96 enrolled subjects, 14 subjects withdrew their consent for participation before randomization and an additional 25 subjects were withdrawn before randomization because of violations of inclusion/exclusion criteria or because their angiograms were rejected by the central reading site as not meeting the pre-specified criteria.
757611|NCT00220779|The study was conducted in 31 study centers in Austria, Canada, Czech Republic, Germany, United Kingdom, Greece, Hungary, Israel, Poland, and the United States.|
757612|NCT00220740|The study was conducted at 31 study centers in USA, Poland, Argentina, Czech Republic, Canada, Mexico, Italy, Israel, Germany, and Serbia.|
757613|NCT00220727|Single-center, open label study in patients with a confirmed diagnosis of Idiopathic Thrombocytopenic Purpura (ITP).|
757614|NCT00220701||
757615|NCT00220636||
757616|NCT00219557||
757617|NCT00219544|This study was conducted in Canada.|405 subjects enrolled - 234 completed the single-blind phase. Subjects who responded (≥30% decrease in weekly mean pain score) during single-blind entered double-blind. 158 subjects assigned to study drug in double-blind phase. One subject in placebo group was randomized in error, not treated, not included as discontinuation;157 received treatment.
757618|NCT00219349||
757619|NCT00219284||
757620|NCT00219141||
757621|NCT00218634|First participants from methadone clinics, remainder from MGH or RIH clinics.|Participants had to screen for study inclusion/exclusion criteria before randomization.
757622|NCT00218543|Participants were seeking treatment for problems related to cocaine use and were recruited by local advertising/referrals in the New York City area. Two types of adS were placed: (1) ads for treatment of cocaine dependence, and (2) ads for treatment for cocaine dependence and possible problems with inattention and/or hyperactivity.|
757623|NCT00218491||
757624|NCT00218465||
757625|NCT00218439||
757659|NCT00215683|Participants who completed the main FE200486 CS12 study were asked to continue into the FE200486 CS12A extension study.|189 participants were randomized into the main study CS12 and 147 patients completed CS12. Of these, 137 participants were recruited into the extension study CS12A and 109 participants signed the informed consent for dose shift.
757626|NCT00218426|Subjects (SS) are from Leningrad Regional Alcoholism and Substance Abuse Treatment Center, Leningrad Region; and St. Petersburg City Alcoholism and Substance Abuse Treatment Center, screened for detoxification and if met study criteria and interested were referred to study on day of discharge. First SS admitted on 7/31/06, last visit was 1/4/09.|SS were opioid dependent with physiological features for at least 1 year, negative urine for opioids, had ability to give informed consent, not on psychotropic medication, if female, not pregnant, could provide at least 1 relative contact, no significant lab abnormality, and not major psych disorder.
757627|NCT00218387||
757628|NCT00218335|Recruitment was conducted from March 2004 to March 2006. Two types of participants were recruited: Index and Risk Network Members. Recruitment methods for Index included: street-based outreach, word of mouth, ads and referrals from community agencies. During the Index's baseline interview, a list of Risk Network Members was generated.|Two types of participants were enrolled in the study- index and networks. Networks did not go through the intervention or control condition. Index participants had to refer a network member AND show up for randomization in order to be enrolled in the intervention or control condition.
757629|NCT00218296|Subjects were recruited from 3/2007 through 5/2008.|Subjects who called the clinic were randomized to usual care (immediate cessation) or tobacco reduction to quit. Those who did not meet eligibility criteria at their first clinic visit due to unstable health, tobacco use rate, or other exclusionary criteria were dropped from the study.
757630|NCT00218257||96 participants were consented. 45 participants began the first in-hospital study visit. The remaining 41 participants were lost to follow-up or chose not to participant after consenting. 45 participants completed the first 4-day inpatient study visit. 38 participants began and completed the second inpatient study visit.
757631|NCT00218062||
757632|NCT00218036||54 were enrolled, but only 51 were randomized and started the study.
757633|NCT00218023||101 subjects were enrolled and began phase 1 (in phase 1, all enrolled subjects received the same intervention, motivational interviewing, which is described in the Interventions section). 81 completed phase 1, and 81 started phase 2, as described in the Period below. Subjects were assigned to the 4 arms at phase 2.
757634|NCT00217971|All participants were seeking outpatient treatment for problems related to marijuana use and were recruited by local advertising or by clinical referrals in the New York City metropolitan area. Recruitment ran from 3/05-8/09 and patients participated in the trial at a research clinic at Columbia University.|The trial included a one-week placebo lead-in phase. Individuals who were able to significantly decrease their marijuana use during the first week of the study were not randomized. Participants who reported marijuana use less than twice a week during the placebo lead-in phase were considered placebo responders.
757635|NCT00217724|Participants were recruited from oncology clinics at OHSU.|
757636|NCT00217672|Recruitment period from March 2005 to September 2006 at academic medical clinics and community medical clinics.|
757637|NCT00217620||
757638|NCT00217594||Out of 40 enrolled subjects, only 31 subjects were evaluable.
757639|NCT00217581||
757640|NCT00217490|Women in Kaiser Permanente were identified from the electronic medical record and sent a letter inviting them to participate in the study. Recruitment started in 2003|Women who agreed to come in for the initial visit and randomization were excluded if they were not willing to change diet or physical activity, could not speak and read English.
757641|NCT00217464||
757642|NCT00217438|This trial opened for enrollment September 2005 and completed enrollment in June 2012. Patients were enrolled at 4 centers: University of Washington, Seattle, WA; Veteran's Administration Puget Sound Healthcare Administration, Seattle, WA; Cedars Sinai Medical Center, Los Angeles, CA; and James Wilmot Cancer Center in Rochester, NY.|
757643|NCT00217425||
757644|NCT00217399|Subjects were recruited from 22-Sep-2005 through 01-Jul-2009|
757645|NCT00217087|Patients were recruited from December 1, 2005 thru April 26, 2011 at Mayo Clinic in Rochester, Minnesota.|We intended to recruit 100 patients with early cancer and were able to recruit a total of 124 patients in this single center randomized trial. A total of 73 patients could actually be randomized due to inability to completely remove the cancer, finding evidence of high risk of metastasis, or refusing randomization to photodynamic therapy.
757646|NCT00217022|Participants were recruited from Mayo Clinic, Rochester, Minnesota from June 2003 - February 2008.|
757647|NCT00216736||
757648|NCT00216671||
757649|NCT00216476|Subjects had a diagnosis of schizophrenia or schizoaffective disorder (according to the Diagnostic and Statistical Manual of Mental Disorders - 4th edition [DSM-IV]) and were treated with oral risperidone, olanzapine, or conventional oral neuroleptic monotherapy at screening. They were to be symptomatically stable but not optimally treated.|
757650|NCT00216320|Recruitment took place between May 2005 and December 2008 at 9 Rehabilitation centers in the USA.|
757651|NCT00216203||
757652|NCT00216125||77 patients who started the pre-randomization arm were not randomized due to the following reasons: toxicities, disease progression, ineligibility, patient decision, death, physician decision, and other miscellaneous reasons. Only patients who were randomized to consolidation therapy or observation are included in the study analysis.
757653|NCT00216099||
757654|NCT00216086||
757655|NCT00216060|Target patients were men with castrate resistant prostate cancer for whom androgen-deprivation therapy was planned. Patients were enrolled at multiple outpatient oncology clinics and urological practices in the United States and Canada. Recruitment period was December 2003 and August 2005.|1:1 stratification was based on patient's age, performance status and severity of metastatic disease. Initial clinical evaluation was performed during the 2-week screening period. Both arms received at least 500 mg/day oral calcium carbonate and 400 IU of vitamin D.
757656|NCT00215943|Recruitment began at Moffitt Cancer Center in June of 2003 and ended prematurely in December of 2007.|90 participants were consented. 83 were eligible and randomized to treatment arms. 2 became ineligible after randomization and prior to treatment. 8 withdrew prior to treatment. 73 began treatment.
757657|NCT00215930||Assignments: High ERCC1 expression and High RRM1 Expression - vinorelbine plus docetaxel (DV); High ERCC1 expression but NOT High RRM1 expression - docetaxel plus gemcitabine (GD); High ERCC1 expression, but HAVE High RRM1 - carboplatin plus docetaxel (DC); High ERCC1 expression and do NOT have High RRM1 - carboplatin plus gemcitabine (GC)
757658|NCT00215787||
757660|NCT00215657|Participants who responded to degarelix in FE200486 CS07 (NCT00818623) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS07.|180 participants started the main study CS07 and 172 participants received degarelix treatment (intention-to-treat population). Of these, 131 participants were recruited into the extension study CS07A
757661|NCT00215644||
757662|NCT00215553|Recruitment occurred between May 2001 to February 2006 in hospital ICUs|
757663|NCT00215540||
757664|NCT00215150|Recruitment was from the immediate surrounding area, by use of Institutional Review Board (IRB) approved television and radio advertisements, along with flyers.|
757665|NCT00215137||
757666|NCT00214903|Overall, 31,321 patients were recruited for the EURAS HRT study. 724 patients were excluded due to protocol violations (e.g., patient agreed to participate but never started to use the new HRT preparation or continued to use a previously prescribed preparation).|
757667|NCT00214786|Recruitment period took place between April 2003 thru November 2005. Consent took place in the transplant clinic at Baylor University Medical Center (BUMC).|Patients signed informed consent after a consultation visit with tyhe PI. Then they proceeded through the evaluation phase of the study. During this phase, some patients were excluded based off of clinical findings (i.e. lab reports or procedures that did not meet protocol standards).
757668|NCT00214539||
757669|NCT00214526||
757670|NCT00214500||
757671|NCT00214487||
757672|NCT00214461|Participants were enrolled and treated from 01 November 2005 to 11 October 2006 in 3 medical centers in the US.|A total of 48 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
757673|NCT00214422||6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study.
757674|NCT00214383|The study extended 1,988 invitations, resulting in eligibility screening for 702 cases over the phone. A total of 305, or about 15% of the 1,988 invitations, enrolled. Some of the reasons for non-enrollment include inability of clients to reach phone, not having moderate to severe asthma, or up to 3 no shows for scheduled intake appointments.|After initial eligibility screening, 305 parent/child dyads enrolled for study. However, four dyads dropped out after intake, but prior to randomization. Of the remaining dyads, 153 were assigned to the control group and 148 to the experimental group.
757675|NCT00214201||
757676|NCT00214149||
757677|NCT00214136|This study enrolled patients with high-risk prostate adenocarcinoma or radiographic evidence of pelvic lymph node involvement but absence of distal metastases from the Midwest. The last patient completed in February 2016.|All participants are assigned to the experimental arm.
757678|NCT00214097||
757679|NCT00214045||
757680|NCT00214019|Subjects were recruited at UW Hospital and Clinics, Madison, WI from November 2003 to January 2008.|6 participants completed all four arms of the study. 36 participants were recruited; 17 screen failed prior to randomization, 11 were lost to follow up prior to randomization, and 2 withdrew consent prior to randomization.
757681|NCT00213980|The University of Wisconsin Comprehensive Cancer Center (UWCCC) conducted a clinical trial of adjuvant ZA in postmenopausal women with high-risk breast cancer, open through the Wisconsin Oncology Network (WON). Participants were recruited from 2000 through 2007.|
757682|NCT00213239||
757683|NCT00213148||
757684|NCT00213135||
757685|NCT00212888||
757686|NCT00212758|This is a multicenter trial. Patients were recruited from pediatric nephrology clinics at various centers.|A two month run-in period was implemented to stabilize subjects and correct any metabolic abnormalities that may affect growth. This two month period may be waived per the center PI if patient was deemed stable. Patients were randomized to either a low or standard dose of GH (Nutropin AQ)used in the IGF-I generation.
757687|NCT00212446|The study period was from February 2005 through April 2012 and was performed on the labor and delivery floor of the study sites.|
757688|NCT00212355||
757689|NCT00212264||
757690|NCT00212134|Recruitment 12/23/04 to 01/16/09 at 12 medical clinics.|Final eligibility determined at pre-operative ocular examination under anesthesia.
757691|NCT00211887|The trial enrolled participants from January 2005 through April 2009. The trial was conducted in 68 sites, both private practice and academic, in the USA and Canada.|1129 participants assessed for eligibility. 121 excluded due to recent activity (16), <2 exacerbations (14), other medical exclusions (14), inconclusive for RRMS (12), abnormal lab value (10), cannot have Gd (5), EDSS>5.5 (2), and other reason (46).
757692|NCT00211809|Subjects were recruited by advertising and other media and by referral from outside clinicians.|
757693|NCT00211757||
757694|NCT00211692|Patients with difficult-to-treat characteristics (78% VA) were enrolled at 7 Veterans Affairs (VA) and 2 community medical centers.|All eligible patients were randomized and analysis performed using intention to treat.
757695|NCT00211536|Centers were either university or clinic based endocrinology centers. The centers were required to recruit from their current patient population. This ensured that they had knowledge of the medical and behavioural history prior to enrollment. The experimental pumps were to be implanted and so the study could not be blinded.|All subjects trained on testing for Low Blood Glucose Index (LBGI) and a baseline collection of this data for all subjects was collected prior to a block randomization plan. The randomization visit occured 14 days prior to the study start, to allow for scheduling of the implantation surgery for those randomized to the MIP arm.
757696|NCT00211510||
757697|NCT00211237|Of 134 enrolled subjects, 70 were randomized to Balloon Kyphoplasty and 64 to non-surgical management (NSM). Two of the subjects who were randomized to Balloon Kyphoplasty and 3 of the subjects who were randomized to NSM were excluded from the mITT and PP Populations, because they terminated in a few days of enrolment and had no treatment.|Crossover from the NSM group to Balloon Kyphoplasty group was permitted after completion of the 1-month evaluation.
757698|NCT00211185||
757699|NCT00211172||
757700|NCT00211081||
757897|NCT00190749||Study Period I was a Screening Period. Study Period II was a Inpatient Washout/Diet Stabilization Period. Study Period III (randomization) was the Double-Blind Therapy Period.
757701|NCT00210639|For this study, a total of 2233 participants were enrolled; 1620 participants from 2 otitis media studies (LOFBO-OTMD-001, LOFBO-OTMD-002) and 613 from a community acquired pneumonia study (LOFBIV-PCAP-003).|Only 207 participants out of 2233 participants were required for yearly follow-up during the Musculoskeletal Disorder (MSD) follow-up phase.
757702|NCT00210626||ITT subjects were all randomized subjects. Three subjects were randomized prior to screening and failed screening. These 3 subjects did not receive any study medication or procedure prior to discontinuation and are not included in the 192 subjects that started the study.
757703|NCT00210470|The first subject was enrolled July 2005 and the last subject visit was August 2009.|"Pathologically confirmed (by histology) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
~No prior surgery, radiation therapy, or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care.
~No medical contraindications to surgical resection and reconstruction required."
757704|NCT00210353|Subjects were enrolled from 10 January 2003 to 07 July 2010|
757705|NCT00209560|This study recruited at 18 centers in the US during the period of 29-Oct-2004 to 24 Mar 2005.|After enrollment and before randomization all subjects, irrespective of treatment group assignment,received fentanyl citrate injection 0.5 µg/kg to 1 µg/kg(based on age)as an analgesic pretreatment 5 minutes prior to the administration of either fospropofol disodium (Also known as,LUSEDRA and formerly known as AQUAVAN) or midazolam midazolam HCl).
757706|NCT00209417|"656 subjects enrolled. 8 subjects did not continue on in the study. 7 of the 8 subjects discontinued the study prior to contrast media administration and 1 of the 8 subjects received a contrast media of unknown type and was excluded from the study.
~Subtracting 8 subjects from the total 656, a total of 648 subjects actually completed the study."|
757707|NCT00209339|A total of 55 EVEREST I patients were enrolled at 11 sites.The first EVEREST I patient was enrolled on July 2, 2003 and the last patient was enrolled on February 15, 2006.|Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation determined from a transthoracic echocardiogram (TTE), who were candidates for mitral valve (MV) surgery and cardiopulmonary bypass were considered for enrollment in this study.
757708|NCT00209274|The EVEREST II RCT was conducted in patients who were indicated for and could undergo mitral valve surgery. A total of 279 patients were enrolled at United States & Canada investigational sites between Aug 5,2005 to Sep 17,2008 time period. The subjects were randomized to Device group (n=184; MitraClip) &Control group (n=95;Mitral Valve Surgery).|"The EVEREST II RCT enrolled 279 patients (184 Device and 95 Control), of whom 21 patients (6 Device and 15 Control) did not undergo treatment per their randomized assignment, and are reported as randomized not treated (RNT). All RNT patients except one withdrew from the trial."
757709|NCT00209170||The study consented 20 subjects, but 6 subjects were not randomized into treatment groups because they were lost to follow-up.
757710|NCT00209131|Patient recruitment took place in a medical clinic affiliated with a teaching hospital from May 2005 through February 2009.|
757711|NCT00209092||
757712|NCT00209027||
757713|NCT00208975||
757714|NCT00208949||
757715|NCT00208767|Emory Healthcare sites or by advertisement between March 2005 and October 2008.|60 of the enrolled subjects were already on long-term statin therapy and were stratified for statin use before randomization. Subjects on statin therapy were switched to simvastatin 40 mg daily unless they were already on high dose statin therapy and thus were placed on 80 mg daily of simvastatin for the duration of the study.
757716|NCT00208507|"Patients were selected for recruitment into the study from the general diagnosis population defined as primary total hip arthroplasty (THA) for non-inflammatory degenerative joint disease (NIDJD). The investigation was conducted at 8 centers. Each center randomly assigned patients to both the investigational and control treatment groups."|
757717|NCT00208494|Eleven sites enrolled 392 subjects who were then randomized into two groups. The investigational group, Ceramic-on-Metal (COM) and the control group, Metal-on-Metal (MOM). Two subjects were intraoperatively excluded, resulting in 194 subjects COM subjects and 196 MOM subjects.|
757718|NCT00208325||754 subjects were consented into the study, however only 720 received study treatment.
757719|NCT00208091|The dates of recruitment for this study were from April 2003 to May 2008. Both male and female subjects were included. Each subject must have been diagnosed with a focal, task-specific dystonia which was clinically determined to be the result of a high level of musical skill and intensive performance history to be included in the study.|
757720|NCT00208026|"This was an open-label,single-arm study to investigate the safety profile of topical pimecrolimus cream.
~Patients meeting the criteria for diagnosis of Netherton Syndrome were enrolled over a period of 3 years, from September 2005 through March 2008. The study was conducted in my medical office within The Children's Hospital of Philadelphia."|The eligibility was for male and female patients aged 2 to 18 years.They were required to have normal laboratory values within 3 months prior to enrollment. A 4 week washout period was required for systemic steroid, tacrolimus, immunosuppressives, phototherapy, and inhibitors of Cytochrome. 2 week washout for Isoenzyme,tacrolimus and pimecrolimus.
757721|NCT00207883||
757722|NCT00207740|A total of 309 patients were randomized into 4 parallel treatment groups at 53 sites (134 patients at 27 sites in the US and 175 patients at 26 sites in Europe). The first patient was consented on 31 Aug 2004, and the last patient completed the study on 17 Jul 2007.|
757723|NCT00207727|A total of 249 patients were enrolled in the trial to receive either placebo or ustekinumab (CNTO 1275). There were 38 investigative sites in North America, Europe and Australia.|
757724|NCT00207714|A total of 172 participants were randomly assigned to treatments at 33 sites: 16 in North America (13 in the US and 3 in Canada), 12 in Europe (3 in Belgium, 4 in the UK, 5 in Germany), and 5 in Australia. The study period extended from 01 Dec 2003 to 21 Feb 2006.|
757725|NCT00207142||288 subjects were enrolled, of which 36 did not start Induction Phase Therapy (22 did not meet study criteria, 6 withdrew consent, 4 lost to follow-up, 3 had missing information, and 1 for investigator's decision).
757726|NCT00207090||19 participants were enrolled and 15 were treated with the study drug. 4 participants were not treated (1 participant due to an adverse event [AE] and 3 participants for no longer meeting study criteria)
757772|NCT00201877|From December 2005 until June 2009, 25 patients aged ≥ 18 years with historically confirmed, grade 1 or 2 mantel cell or follicular NHL according to the World Health Organization classification who relapsed or were refractory after at least 1 previous therapy.|
757727|NCT00206726|The study was conducted at 27 centers in the United States from 12 May 2005 (date of first participant's first visit) to 10 April 2008 (date of last participant's last visit)|66 screened, 6 screen failures, 60 enrolled and registered (Intent-to-Treat [ITT] population), 3 withdrew consent prior to receiving therapy = 57 treated (Safety population); 41 received at least 4 therapy cycles with no major protocol deviation or progressed/relapsed or died before completing 4 cycles (Per Protocol [PP] population)
757728|NCT00206518||
757729|NCT00206440||
757730|NCT00206427||
757731|NCT00206375||
757732|NCT00206336||
757733|NCT00206323||
757734|NCT00206102|A 24-month, multi-center, evaluator masked (ophthalmologist), open-label, flexible-dose, parallel-group study, 82 sites recruited Sept 2003 through Oct 2008. In total 1099 participants were randomized by Interactive Voice Response System (IVRS). One excluded participant was randomized before the rand visit, and never returned to any study visits.|Screening for eligibility and must be cross-tapered off of all previous antipsychotic medications
757735|NCT00206076|Participants were current patients from 3 outpatient transplant offices and recruited between July 2006 and May 2008.|Participants were screened over a 2 week period. Three participants withdrew consent after signing the consent form. One participant failed screening (didn't attain threshold MPA level). These subjects were excluded from the trial before assignment to groups.
757736|NCT00205881||
757737|NCT00205855||
757738|NCT00205803|Participants were recruited in the United States from September 2004 to September 2005.|Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.
757739|NCT00205777||
757740|NCT00205712||
757741|NCT00205699||Post-enrollment screening for inclusion and exclusion criteria, e.g. for exclusionary conditions like diabetes mellitus.
757742|NCT00205660|Participants were recruited from wide range of sites in the St. Louis community. Some advertising with flyers was used however the majority of the recruitment was done using community outreach, doctor-to-doctor or self-referrals, and referrals from board and care and community support programs. All recruitment materials were approved by the IRB.|Participants were enrolled in the study once they signed consent. After enrollment, participants were brought in for a screening visit consisting of a diagnostic interview, screening labs, a review of records and a discussion with their primary psychiatrist. If the patient met all inclusion criteria after screening, study visits were scheduled.
757743|NCT00205504||Although 46 completed informed consent, only 36 initiated the study. Among The participants who did not begin the study were lost to follow-up prior to beginning the protocol, were no shows, or withdrew from the study before beginning study procedures.
757744|NCT00205374|The participants in this randomized, double-blind, placebo-controlled clinical trial were 19 consecutive adult or pediatric patients who presented to the University of Wisconsin Otolaryngology-Head and Neck Surgery Clinic with a diagnosis of RRP who met inclusio/exclusion criteria and gave informed consent to participate.|Before inclusion in this study, and 48 hours before each cidofovir injection, laboratory tests confirmed that the (female) participants were not pregnant and that laboratory findings were not exclusionary for study participation.
757745|NCT00205348|Patients undergoing thyroid surgery from May 2002 to December 2004 completed the SWAL-QOL questionnaire before and one year after surgery.|
757746|NCT00205179||4 subjects withdrew consent; 3 subjects ineligible due to abnormal laboratory tests or inability to complete testing
757747|NCT00205049||
757748|NCT00204932||
757749|NCT00204737||
757750|NCT00204373|Patients were recruited from the GI/Hepatology clinic located at The Kirklin Clinic. Patients were referred here from their primary care physician or chose this clinic through self-referral for care for a GI issue. Patients were recruited between early 2003 and early 2010.|The first phase of this study involved a short-term dose determination phase followed by a long-term treatment phase.
757751|NCT00203996||
757752|NCT00203931||
757753|NCT00203892|66 patients screened between August 2004 and September 2009|
757754|NCT00203502|This study recruited patients from September 9, 2005 through January 17, 2008. Patients were recruited from hematology/oncology clinic at the Winthrop P. Rockefeller Cancer Institute of the University of Arkansas for Medical Sciences.|
757755|NCT00203476|Patients were recruited from 2005-2007 from primary care medical clinics.|Patients had to be on max tolerated dose of a statin and need additional LDL lowering.
757756|NCT00203424|Dates of recruitment period: 6/23/2005 - 03/10/2009 Types of location: Academic medical clinics and community medical clinics.|There are no pre-assignment details to describe.
757757|NCT00203411|Dates of recruitment period: October 2005 to February 2009 Types of location: Academic medical oncology clinical and community medical oncology clinics|
757758|NCT00203307||
757759|NCT00203294||
757760|NCT00203268||
757761|NCT00203242||
757762|NCT00203229||
757763|NCT00203216||
757764|NCT00203203|Thirty patients were recruited between 4/14/04 and 2/8/07 from outpatient cardiology clinics.|
757765|NCT00203047||
757766|NCT00203021|Participants who participated in both or either Studies 01-9001 (double-blind [DB] placebo-controlled study) and 01-9001E (DB extension study) were eligible to enter into this open-label extension study. Note that the 01-9001 and 01-9001E studies predate NCT assignments.|A total of 209 participants were screened; 208 participants met entry criteria and were enrolled in this study.
757767|NCT00202878|Adult men and women presenting with non-ST segment elevation myocardial infarction (NSTEMI) , STEMI, or hospitalized, documented unstable angina (UA) whom a percutaneous coronary intervention (PCI) was planned as management for the qualifying acute coronary syndrome (ACS) event were eligible for entry into the trial.|Study continued until a minimum of 5,250 participants had a primary endpoint event and each participant was followed for a minimum of 2.5 years.
757768|NCT00202839||
757769|NCT00202722|Recruited at arrival to the Labour department|
757770|NCT00202644||A total of 183 participants were screened, 149 participants were randomized at 29 sites across 10 countries. Four (4) participants randomized but withdrawn prior to treatment and 1 participant not randomized but treated.
757771|NCT00202449||
757780|NCT00201643|Pregnant women were recruited at 18 private (15) and university (3) medical centers from May 2003 through February 2008.|no washout, run-in or transition events occurred between enrollment and group assignment.
757781|NCT00201448||
757782|NCT00201409||
757783|NCT00201240|Patients were recruited from October2005 through December 2008|
757784|NCT00201201|Participant recruitment brochures and posters with the advanced practice nurses' (APRNs) names/practice contact information were placed in practice waiting and examination rooms. Older adults self-referred for the study by calling the practice and making an appointment with the APRN. Recruitment was rolling during Sept. 2007 - June 2009.|Exclusion criteria were less than age 60; health literacy score below 44 (6th grade); not currently prescribed antihypertensive medication; visual acuity of less than 20/100 (with corrective lenses, if needed); inability to meet independent-living and cognitive-functioning ability.
757785|NCT00201123||
757786|NCT00201006|Study announcements were mailed to households in 6 rural counties in northern Florida designated in whole or in part as health professional shortage areas. Women who responded to the announcements were invited to an orientation/screening session wherein informed consent was obtained. Height and weight were measured by a registered nurse.|298 women participated in a standard 6-month lifestyle modification program for weight loss, delivered in groups at Cooperative Extension Offices. Eligibility for randomization required completion of the 6-month lifestyle program; 234 completed the initial treatment and were assigned randomly to one of the three extended care conditions.
757787|NCT00200967|Recruitment for the LARGE trial began in November 2004 and the final participant visits occurred in February 2008. Seven academic medical centers throughout the US recruited the participants.|474 participants were screened: 78 had B16 Arg/Arg genotype; 166 had B16 Gly/Gly genotype; 230 had Arg/Gly genotype. 47 matched Arg/Arg-Gly/Gly pairs entered the 8-week run-in period. 42 Arg/Arg were randomized (2 withdrew, 2 noncompliant, 1 lost); 45 Gly/Gly were randomized (1 withdrew, 1 noncompliant).
757788|NCT00200902|133 subjects were screened for eligibility and 88 were eligible for enrollment between 8/19/05 - 8/7/08 at the UCLA Laboratory of Brain, Behavior, and Pharmacology. 88 participants were randomized however, n=67 for many of the measures as subjects who did not complete the Week 8 visit were not included in the analysis.|Subjects were required to wash out of any other antidepressant medications for one week (30 days if washing out from fluoxetine).
757789|NCT00200850||"Out of 31 participants enrolled, 6 participants withdrew due to non-treatment-ascribed-event, 4 participants withdrew due to treatment-ascribed-events.
~Only 21 participants completed the study."
757790|NCT00200785|healthy participants were recruited in Utah county, Utah, in early 2006|
757791|NCT00200356||
757792|NCT00200343||
757793|NCT00200161||"85 participants had a Glioblastoma diagnosis.
~The remaining participants consist of an exploratory cohort of Grade 3 tumors."
757794|NCT00200057|The clinical investigation began on January 14, 2002, and the first implant occurred on May 03, 2002. The study was closed to enrollments on June 15, 2006, and the last implant occurred on August 04, 2006.|All patients who signed an informed consent were considered enrolled in the study. Of the 285 subjects who enrolled in the study, 132 subjects underwent acute test stimulation with 129 proceeding to the sub-chronic test stimulation phase. Of these, 120 subjects qualified for permanent implant. All 120 patients were successfully implanted.
757795|NCT00199914|A randomized and double blind placebo controlled equivalence trial was carried out in the out-patient clinic, Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University from January to June 2004.|All patients had primary knee OA and without the following conditions: inability to walk, severe joint instability, history of previous SWD treatment, intra-articular injection within 3 months, metallic implant around knee joint, suspicious of malignancy around knee joint, significant cardiovascular disease.
757796|NCT00199875||
757797|NCT00199381|73 study centers in the US and Canada recruited subjects from the initiation date (28 October 2005). Patients who had previously participated in Study 6002-INT-001 were eligible to participate in this follow-on safety study,and hence had been taking istradefylline for at least a year.|Subjects completing 6002-INT-001 immediately before entering the study had an interruption of study drug of 30 days or less. Qualifying subjects with an interruption of more than 30 days had their baseline visit after laboratory tests results were reviewed by the Investigator.
757798|NCT00198822|Women were recruited into the trial from August 2001 to January 2007. As this was a community trial, we identified pregnant women by conducting a urine test on women reporting to be amenstrual from the last visit during 5 weekly visit cycles to their homes in rural communities of the districts of Rangpur and Gaibandha, Bangladesh.|
757799|NCT00198133|This protocol was based on getting 27 evaluable patients through a two-stage design|
757800|NCT00198107||
757801|NCT00198081||
757802|NCT00198042|Patients were recruited from one surgeons practice.|
757803|NCT00198029|Patients with painful CMC OA and radiographic changes of Kellgren and Lawrence (K+L) Grade 2-4 were recruited from rheumatology and hand surgery practices at the Hospital for Special Surgery from 2004-2005|Exclusion criteria included: age < 45, systemic rheumatic disease, self-reported comorbid hand conditions, history of gout or pseudogout, bleeding diatheses, previous surgery to the involved thumb, and no evidence of CMC joint space narrowing. Patients must have failed some form of conservative therapy, such as NSAIDS, acetaminophen or splinting.
757804|NCT00197496|Patients treated for a hip fracture by orthopedic surgeons and admitted to the inpatient rehabilitation floor of a teaching hospital between September 2006 and November 2007 were considered for participation. A break in recruitment was implemented from November to early January to avoid variation in physiotherapy care related to holidays.|
757805|NCT00197392||
757806|NCT00197236||Of the total of 468 subjects enrolled, only 394 were vaccinated and as such considered as 'started'.
757807|NCT00197184||
757808|NCT00197145|The study was planned on 406 male or female participants infected with Human immunodeficiency type 1 (HIV-1) virus, aged 18 years or older, across 15 centres in the United States and at 1 site in Canada from 21 July 2005 to 11 September 2007. Study was early terminated prior to the completion of enrollment.|A total of 24 participants comprised All Randomized Subject Population who were randomized in a ratio of 1:1 to GW873140 (aplaviroc [APL])+optimized background therapy (OBT) and placebo+OBT. Intent-to Treat (ITT) Population was n=24, used for all analysis.
757809|NCT00197119|At the time of initiation of the long-term follow-up study, the investigators contacted the subjects who had consented to participate in the long-term follow-up studies. At each subsequent visit, subjects who were present at the previous long-term blood sampling time points were contacted again.|
757810|NCT00197106|Participants were eligible to enter the run-in period if they had a documented clinical history of asthma with hyperresponsiveness. Only participants who were symptomatic after this period were eligible to be enrolled into the study and were randomized into either the Salmeterol/Fluticasone propionate (FP) 50/100 mcg plus placebo or FP groups.|257 participants started the run-in phase of the study, and 99 of these did not meet the inclusion criteria to be entered into the treatment phase. Only baseline characteristics for the 158 participants meeting the inclusion criteria and randomized to either salmeterol/fluticasone propionate 50/100 mcg BID or fluticasone 200 mcg BID are provided.
757811|NCT00197054|255 subjects were enrolled and randomized 1:1:1 into each arm at Kombewa Clinic, US Army Medical Research Unit, Kisumu Kenya.|
757812|NCT00197028||The study comprised 2 phases, a double-blind vaccination phase from Month 0 to Month 6, and a single-blind phase (Month 7 to Month 14).
757813|NCT00197015||While the total numbers of subjects enrolled in the study was 1474, the total number of subjects that entered the study was 1241. The remaining subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.
757814|NCT00197002||Out of a total of 521 subjects enrolled, 88 subjects were not administered a study vaccine dose and thus were not considered to have started the study.
757815|NCT00196976||During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
757816|NCT00196937||Out of the 667 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 666.
757817|NCT00196716||
757818|NCT00196326||A total of 2968 subjects were screened and 2235 subjects were enrolled in the study. Of those enrolled, 2185 took at least one dose of study medication.
757819|NCT00196313||A total of 123 subjects were screened, of which 95 subjects were randomized. Of those randomized, 95 subjects took at lease 1 dose of study medication.
757820|NCT00196196|Subjects were enrolled between September 29, 2004 and October 13, 2006. Twelve (12) investigational sites within the US enrolled 274 Subjects.|Of the 274 Subjects enrolled, 5 were determined to be ineligible - did not have hydrocephalus, a required condition per inclusion/exclusion criteria. Two (2) Subjects withdrew early. Overall, 267 Subjects were eligible for analysis.
757821|NCT00196105||
757822|NCT00195819|The placebo group included subjects who were randomized to placebo even if they received early escape open label adalimumab. The adalimumab exposure group included subjects who were randomized to blinded adalimumab.|
757823|NCT00195715||
757824|NCT00195702|Subjects were enrolled at 95 sites in the United States and Canada between February 2000 and August 2001.|Eligible subjects who were taking disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) entered a 4- to 6-week washout period, during which previous DMARDs (except MTX) were discontinued. Subjects who were not taking DMARDs, other than MTX, entered directly into the 52-week double-blind treatment period of the study.
757825|NCT00195676||
757826|NCT00195663|Patients were enrolled at 94 sites in 15 countries between January 2001 and April 2004.|Patients who had been receiving a previous disease-modifying anti-rheumatic drug (DMARD) participated in a 4-week washout period during which the DMARD was withdrawn. Otherwise, there was a one-week washout period after the Screening visit.
757827|NCT00195650||
757828|NCT00195624||
757829|NCT00195507|Subjects were recruited in multiple countries worldwide from to.|Subjects were screened up to 4 weeks.
757830|NCT00195494|Participants were recruited worldwide from November 2004 to February 2006.|Participants were randomly assigned equally to 1 of 4 blinded treatment groups: Group (G) 1a received the combination of etanercept (E) and methotrexate (M) in year Y1 and Y2. G1b received the combination of E and M in Y1 and E alone in Y2. G2a received M alone in Y1 and the combination of E and M in Y2. G2b received M alone in Y1 and Y2.
757831|NCT00195442|A total of 288 participants were observed during the study in 48 centers (44 Germany and 4 Austria) from time of First subject first visit May 1999 to Last subject last visit January 2010.|The study was terminated January 2010 due to the introduction of a successor product ReFacto® AF.
757832|NCT00195429|Subjects were recruited in Brazil from August 2005 to September 2006.|After renal transplantation subjects were immediately randomized into day 1.
757833|NCT00195403|Results for three unique protocols 0881A-101575 (NCT00195403), 0881A-102018 (NCT00195416), and 0881A-102212 (protocol not registered) were summarized in a single clinical study report.|Total of 1016 case report forms were retrieved, of these 2 were double registered. Out of 1014 participants, 16 were enrolled prior to the agreement date of the study and therefore excluded from the safety analysis population (998). Three participants had missing efficacy assessments (efficacy population = 995).
757834|NCT00195351|Subjects were recruited worldwide from September 2005 to February 2008.|Subjects were screened up to two days.
757835|NCT00195338||
757836|NCT00195273|Patients were recruited in Sweden from November 2004 to September 2007.|Prior to enrollment in study, patients were screened for eligibility. If eligibility criteria were met, patients were enrolled and randomized.
757837|NCT00195260||
757838|NCT00195039||
757839|NCT00195013||
757840|NCT00194987|pregnant women with a fetus affected by FNAIT were enrolled at multiple sites with local IRB permission and local consents fetuses were tracked in utero and after birth for 2 weeks|
757841|NCT00194896|Recruited through endocrinology physicians.|
757842|NCT00194792||
757843|NCT00194779||
757844|NCT00194675|Subjects were recruited from the VA Puget Sound Health Care System, Seattle, WA. 102 men were screened and 53 were randomized.|49 were excluded. 4 withdrew consent, 3 lost to follow-up, 42 for inclusion/exclusion criteria: 3 could not tolerate MRI, 3 were previously on testosterone therapy, 21 had prostate volume <30cc, 12 had repeat serum testosterone >280 ng/mL, and 3 had prostate cancer or prostate intraepithelial neoplasia at pre-treatment prostate biopsy.
757898|NCT00190684||
757845|NCT00194610|20 subjects were recruited to a double blind study comparing Botulinum toxin A to normal saline. Each subject received either 50 units of Botulinum Toxin A or normal saline in the periurethral tissue in the Urology Clinic of the University of Washington.|No pre-assignment criteria were used.
757846|NCT00194532||
757847|NCT00194129|The study was conducted at the outpatient Mood Disorders Program of Case Western Reserve University/University Hospitals Case Medical Center between October 1997 and October 2006.|Patients meeting stabilization criteria for a minimum of 4 consecutive weeks were eligible for random assignment to double-blind maintenance treatment. Patients not meeting these criteria by 24 weeks were discontinued from the study.
757848|NCT00194116||
757849|NCT00194077|Recruitment University Hospitals, Case Medical Center|Open stabilization was initiated with aripiprazole at~0.1mg/kg upon phase 1, open stabilization entry, n+96. Of these, 60 subjects met priori response to advance to phase 2.
757850|NCT00194025|The study was conducted at an academic psychiatry clinic in the mid-western United States. Data was collected from participants from February 2004 to November 2006. Participants were recruited in response to self-referrals from advertisements and by referrals from mental health practitioners.|
757851|NCT00194012|Patients were recruited beginning 8/2004 with follow up interviews completed 5/2012. Families were recruited from an outpatient child/adolescent psychiatric research center and an adult mood disorders program at University Hospitals, Case Medical Center.|After screening and baseline assessments study participants were assigned to aripiprazole or placebo. Treatment was initiated at a dose of 0.1mg/kg/d. The dose could be increased by approximately 0.05 mg/kg/d at each study visit if patient experienced residual symptomology with no intolerable side effect to maximum dose 15mg/d.
757852|NCT00193609||
757853|NCT00193596||
757854|NCT00193492||
757855|NCT00193479||
757856|NCT00193453||
757857|NCT00193427||
757858|NCT00193414||
757859|NCT00193375||
757860|NCT00193258||
757861|NCT00193219||
757862|NCT00193206||
757863|NCT00193180||
757864|NCT00193128||
757865|NCT00193063||
757866|NCT00193050||
757867|NCT00193037||
757868|NCT00192647|Out of total 896 randomized participants, 25 participants (15 in the induction group and 10 in the standard group) did not receive study drug.|
757869|NCT00192296|A total of 24 participants provided written informed consent and participated in the study between 13Aug2004 and 12Nov2004 at one site in New Orleans, Louisiana.|Eligible participants received MEDI-528 in an open-label manner.
757870|NCT00192114||Participant flow reports those who discontinued from study drug.
757871|NCT00192075||
757872|NCT00192036||
757873|NCT00192023||Study Period I=Screening. Study Period II=Standardized behavioral management program for parents (156 entered, 17 discontinued). Study Period III=Double-Blind (randomization). Two patients did not have post-baseline values for the primary endpoint and were not included in Baseline or efficacy analyses. Study Period IV=Optional open-label phase.
757874|NCT00191984||Two participants discontinued the trial before receiving study treatment. One due to entry criteria exclusion and one due to withdrawal by subject. Therefore, 44 participants received at least one dose of chemotherapy and are included in the efficacy and safety analyses.
757875|NCT00191945||158 patients enrolled during the Screening Period (Visits 1 and 2), but 7 did not receive study drug and are not included in the 151 patients randomized in the Double-Blind Period.
757876|NCT00191906||Period I: screening/washout (89 patients screened, 13 screen-failures;45 controls screened). Period II (Visits 2-5): patients received treatment for 4 weeks and then underwent 2-week washout period after which they crossed over to receive the alternate treatment for 4 additional weeks. Period III (Visits 6-12): optional open-label (1 country only).
757877|NCT00191854||
757878|NCT00191815||
757879|NCT00191789||
757880|NCT00191724||
757881|NCT00191646||919 patients were randomized, only 831 randomized patients were included in any analyses. 85 randomized patients were excluded due to significant noncompliant issues and 3 patients were excluded due to unavailable data.
757882|NCT00191477||355 participants were enrolled and randomized (included here in disposition); however, due to study design, only 328 (N=166 Gemcitabine and N=162 Placebo) actually received study drug (Full Analysis Set).
757883|NCT00191451||
757884|NCT00191386|This ongoing study is being conducted as a follow-up investigation of ADHD pediatric patients who completed Study LYBC (NCT00191295).|
757885|NCT00191334||
757886|NCT00191308||
757887|NCT00191282||One patient was randomized but discontinued prior to treatment and is not included in any of the analyses. In the Participant Flow table, the term study outcome is used to differentiate it from serious adverse events (SAEs). By definition, the study outcomes were all SAEs as it was a cardiovascular outcome trial.
757888|NCT00191269||At Step 1, 6 participants each were assigned at Dose Level 1 (gemcitabine:1000 mg/ m2) and Dose Level 2 (gemcitabine:1250 mg/ m2) to determine the recommended dose for Step 2. At Step 2, an additional 56 participants received the recommended dose (Dose Level 2).
757889|NCT00191191||Baseline demographics and efficacy outcome measures are provided for the Full Analysis Set population (all randomized participants who met all inclusion and no exclusion criteria and received at least one dose of study drug).
757890|NCT00191165||
757891|NCT00191152||Not all participants who completed initial treatment went on to crossover treatment. Per protocol, participants had the option to go off study without receiving crossover treatment.
757892|NCT00191139||
757893|NCT00191113|Addenda 1, 2, and 3 are not sequential, and they differ in eligibility criteria. Depending on individual eligibility and choices made, a patient might have participated in none, 1, 2, or all 3 of these addenda.|Addendum 1: provided option of Humatrope treatment to patients who had been randomized to control in Core Study. Addendum 2: extended period of follow-up for 5 years after discontinuation from Core Study. Addendum 3: evaluated possible genomic imprinting effects (published: Hamelin et al. 2006).
757894|NCT00191100||
757895|NCT00190983||
757899|NCT00190671||This was a Phase 1/2 study. Phase 1 determined the doses to use in the Phase 2 portion. In this 2-stage Simon's optimal design study, enrollment in the 600 mg/m2 arm was stopped at the end of Stage 1 because of lack of efficacy; ongoing patients were allowed to continue treatment. Secondary efficacy endpoints were evaluated for 1800 mg/m2 arm only.
757900|NCT00189540||Screening was up to 30 days
757901|NCT00189488||
757902|NCT00189475||
757903|NCT00189462||
757904|NCT00189436||
757905|NCT00189423|The study was conducted under a waiver of informed consent for emergency research that was approved by the U.S. Food and Drug Administration and by the Institutional Review Boards at participating study sites. All adults with out-of-hospital cardiac arrest were eligible for the study.|All sites were required to complete a run-in phase prior to to beginning randomization. A total of 2667 patients (197 run-in, 2470 pivotal) were provisionally enrolled and received randomized CPR treatment. Of these, 1653 pivotal patients met the final selection criteria (non-traumatic arrest due to cardiac cause).
757906|NCT00189306|Study conducted in 18 study centers: 13 in Australia and 5 in New Zealand. The first subject entered this study on 27 March 2001; the last clinic visit was on 20 April 2007 and the last subject status determination (subject lost to follow-up) was on 27 April 2007.|There were 169 subjects enrolled at 18 study centers in Australia and New Zealand.
757907|NCT00189228|Recruitment from the University community|No events prior to the study
757908|NCT00189202||
757909|NCT00189137|84 patients were enrolled and randomized at the University of Michigan, however 4 patients withdrew consent prior to treatment. 80 patients began study treatment.|
757910|NCT00189098|Patients were recruited between February 2003 and June 2006. Otorhinolaryngologists and paediatricians from all over the Netherlands referred potential participants, i.e. children with COM that had failed conventional management with topical medications and/or short term systemic antibiotics|
757911|NCT00187889|The participants was recruited into the study by using flyers, and asked about interest in the medical clinics.|A total of 70 participants were screened for the study. Out of the 70 participants a total of 18 screened failed, 1 patient was withdrawn due to developing a spasm during the provocative testing screening which was believed to represent thrombosis and was not randomized to the study.
757912|NCT00187876||
757913|NCT00187720|Dates of recruitment were 5/2003 through 4/10/2007. Location was General Clinical Research Center (GCRC) at San Francisco General Hospital.|
757914|NCT00187681||
757915|NCT00187655|Enrollment concluded with 24 subjects and study is in analysis phase. Recruitment of subjects were At the CRC at SFGH. Dates of recruitment 2004-9/2011.|No wash-out as these were healthy control subjects not currently on any medications.
757916|NCT00187486|66 patients enrolled from 10/2004 - 2/2006. Patients were enrolled at the UCSF Neuro-Oncology clinic.|
757917|NCT00187369||
757918|NCT00187226|202 patients were enrolled between July 11, 1997 and January 14, 2003 for the therapeutic phase of the trial. Among those patients, 167 were treated with a 1cm clinical target volume (CTV) margin and 35 were treated with a 2cm CTV margin. Local tumor progression was determined by MR imaging.|
757919|NCT00187200|816 patients were enrolled in the trial. Of the patients screened at the 3-month follow up, 572 patients were classified as responders and 102 patients as non-responders.|102 of the patients were non-responders, but only 93 were randomized of which 57 completed the study and had data available for analysis. of the 816 participants screened only 93 wre randomized to treatment. This statement is accurate and appropriate.
757920|NCT00187135|A total of 168 participants were enrolled between March, 2002 and August, 2007.|168 participants were enrolled and were expected to receive 3 Bone Marrow Aspirations/Lumbar Puncture Intrathecal Chemotherapy procedures; 6 patients withdrew (eg: medical withdrawal, withdrawal of consent and other). 162 were randomized, of which 77 completed all 3 treatments.
757921|NCT00187096|49 participants were recruited between October 2005 and October 2011.|49 participants were enrolled on the study. This report is based on results for 25 patients. 24 were donors and were excluded. All analyses are based on the intent-to-treat principle and therefore include all recipients with data available for the reported endpoint.
757922|NCT00186901|429 patients were recruited at St. Jude Children's Research Hospital between August 7, 2000 and July 27, 2006. 4 patients were found to be ineligible and 1 patient was taken off study per the PI's request. 424 patients were available at baseline.|424 total patients were enrolled on the study. 149 patients were ineligible for randomization. 275 patients were identified with Bone Mineral Density (BMD) Z-scores > 0 and thus were eligible for intervention and were randomized to receive either Calcium and Vitamin D supplementation or placebo.
757923|NCT00186888|107 patients were recruited between February, 2005 and June, 2010 (stratum B) and between February, 2005 and November, 2010 (strata A & C).The primary objective was designed only for stratum B patients who had advanced bilateral retinoblastoma and received the investigational window therapy.|107 patients were enrolled on the study. Two patients were excluded as they were deemed to be ineligible after study enrollment. One patient was found to have retinal dysplasia rather than retinoblastoma and the other patient had retinoblastoma but did not fit into any of the defined treatment strata for this study.
757924|NCT00186875|Between May 2004 and August 2012, this study enrolled 47 participants with relapsed or refractory acute lymphoblastic leukemia (ALL): 40 were enrolled at St. Jude and 7 at Rady Children's Hospital.|Seven participants were excluded from analysis: 6 who enrolled and received treatment prior to a therapy change in amendment 1.0 and one who was incorrectly enrolled on this study. Forty participants were included in the analysis.
757925|NCT00186628||
757926|NCT00186537||
757927|NCT00186498|"Patients over age 18 who are referred for ECT for unipolar or bipolar depression were screened and enrolled. All patients receive right unilateral lead placements, and otherwise the entire procedure would be delivered as per usual clinical care at our institution.
~Patients who sign an informed consent for this study were screened for eligibility."|
757928|NCT00186485||
757929|NCT00186446||
757930|NCT00186186|Eligible patients were recruited from the Bipolar Disorders Clinic at the Stanford University School of Medicine in Stanford, California. Patients met DSM-IV criteria for bipolar II disorder, with a current major depressive episode, as determined by the Systematic Treatment Enhancement for Bipolar Disorder (STEP-BD)|
757931|NCT00186121||
757932|NCT00186069||
757944|NCT00185458|Only the subjects who reached menopause within max. of 4 years of the contraception phase were eligible for the Hormone-Replacement Therapy (HRT) phase. 58 subjects discontinued the study during the contraception phase before starting the HRT, and 168 subjects who started treatment did not reach menopause.|489 subjects were screened: 394 subjects started treatment and 95 subjects failed screening. Intent-to-treat (ITT) population included all subjects (N=394) who had the LNG IUS inserted, or for whom the insertion was attempted. 322 subjects without major protocol deviations were included in the Per protocol set (PPS).
757945|NCT00185380|Parous or nulliparous women in good general health and in need of contraception were recruited from medical clinics between April and Nov 2005.|Most screening failures were in-/exclusion criteria not met and over-screening. Randomized: 742 women, Treated: 738 women. Full analysis set (FAS), safety analysis set (SAF) and per protocol analysis set (PPS) were identical (738 subjects).
757946|NCT00185211||The full analysis set includes all 468 participants (particip.) with at least one administration of study drug in the placebo-controlled original study 92012, using treatment groups as randomized according to the minimization procedure regardless of the kind of study treatment (IFNB-1b/placebo) received. 19 subjects did not consent to the Follow-up
757947|NCT00184717|44 sites in Japan|Subjects completed the main period and were offered to continue in the extension period.
757948|NCT00184600|58 sites across the United Kingdom and Ireland. Recruitment period: November 2004-August 2006|Eligible subjects continued their current oral anti-diabetic drug (OAD) treatment (metformin and/or sulphonylurea) without changing the dose throughout the trial. Subjects were asked not to alter their current diet and activities throughout the trial unless clinically necessary. Subjects fasted from 22:00 the evening prior to randomisation.
757949|NCT00184548|150 trial sites globally.|Eligible subjects were those with either blunt and/or penetrating trauma injuries and confirmed clinical indicators for active haemorrhage refractory to standard treatment (including blood component therapy and surgical haemostatic procedures).
757950|NCT00184093|The study began recruiting in July 1999 and recruitment ended in May 2008. All participants were seen and treated at USC Norris Comprehensive Cancer Center and/or at LAC+USC Medical Center.|The study had no pre-assignment criteria. This was an open label study and all participants were given the same treatment.
757951|NCT00184054|Recruitment for this study opened in April 2002 and closed in May 2008. All subjects were seen at USC.|The study has no pre-assignment. All subjects were given the same treatment.
757952|NCT00184028|Participants were recruited at USC/Los Angeles County General Hospital and the USC/Norris Cancer Hopital between March 2005 and October 2007.|The trial had no pre-assignment criteria. All subjects were given the same treatment.
757953|NCT00184002|The study began recruiting in January 2003 and ended in December 2007. All subjects were seen and treated either at USC Norris Comprehensive Cancer Center or at LAC+USC Medical Center.|There were no pre-assignment criteria. All subjects were given the same treatment.
757954|NCT00183963|Participants were recruited from the USC+LAC General Hospital between August 2006 to April 2008.|The study had no pre-assignment criteria.
757955|NCT00183872|Participants were recruited at the University of Southern California cancer center facilities between April 14, 2005 and January 11, 2012.|There are no pre-assignment requirements for this study.
757956|NCT00183794|Participants were recruited from the USC+LAC Women's Hospital and the USC/Norris Cancer Hospital between December 2002 and April 2008.|
757957|NCT00183729|35 subjects were randomized|No significant events. Please see Lenze et al, Int J of Geriatric Psychiatry 2012 article for details.
757958|NCT00183677||
757959|NCT00183625|Patients recruited at the Manchester Mental Health Center, Greater Los Angeles VA, and UCLA Semel Institute|
757960|NCT00183469|Recruitment from October 2004 to September 2007 took place in Univ of Texas Health Science Center San Antonio and Center for Healthcare services and television advertisements.|1st 8 weeks is Open Label phase. Subjects are either in a depressed episode or have been depressed in last 6 mos. In this phase subjects will take lamotrigine and divalproex ER. Those who remained depressed, or developed an episode, during 2 consecutive visits, were terminated at, or by, week 8.
757961|NCT00183456|The sample consisted of women and their social network members. Index participants were recruited through street outreach as well as at health clinics, and other local community agencies. Social network members were recruited by index participants after completion of the index's baseline visit. Recruitment took place from September 2005-July 2007|Those index participants that did not recruit a network member or did not show up to be randomized into a study condition were not assigned to a study condition. Network participants completed study interviews but were not assigned to a study condition and did not participate in the intervention.
757962|NCT00183443||
757963|NCT00183430|Recruitment was conducted from April 2002 through July 2008. Participants were recruited from VA outpatient clinics and flyers in the community.|no significant events.
757964|NCT00183391||
757965|NCT00183339||
757966|NCT00183274|Most patients (n=239) were recruited and seen by Penn research psychiatrists in 4 primary care practices; others (n=95) responded to media advertising (radio & print ads) at the central clinic at the University of Pennsylvania|7-day washout period of any psychoactive medication;other antidepressants and herbal products. Subject on certain medications, such as monamine oxidase inhibitor, investigational and antipsychotic drugs had to be off these medications for at least 30 days.
757967|NCT00183248|One center in the United States enrolled nine subjects who were recipients of living-related (1-haplotype-matched) donor kidney transplants between September 2004 and November 2006.|Participants underwent procedures at screening to establish inclusion/exclusion criteria.
757968|NCT00183196||
757969|NCT00183170||239 participants were enrolled but 27 dropped out prior to randomization into the study arms so a total of 212 were randomized.
757970|NCT00183092|Enrollment began in April 2005 and ended in January 2009. Subjects came from across the USA, as well as Canada, with a plurality from California, and enrolled at one U.S. clinical site (University of California, San Francisco).|425 patients referred; 69 subjects consented/enrolled; 54 subjects eligible/randomized; 3 randomized subjects identified as carriers of PrP (prion protein) gene mutations as determined by analysis of sequence variability of the bovine prion protein gene (PRNP) and excluded from analyses.
757971|NCT00182793||
757972|NCT00182767|A total of 45 patients were enrolled and treated between January 2006 and May 2011|
757974|NCT00182728|March 2003 to July 2007|89 patients consented. Of those 89, 18 were not treated for the following reasons: tumor not seen on ultrasound (2), tumor too close to chest wall (7), tumor too large (1), ineligible pathology (1), ineligible nodal status (1), operating room logistical errors (3), patients withdrew (2), not eligible for anesthesia (1).
757975|NCT00182689||
757976|NCT00182637||
757977|NCT00182325||
757978|NCT00182091||
757979|NCT00182078|Participants and their guardians were recruited from a major pediatric burn center for an acute burn or for reconstructive surgery for a burn.|One participant withdrew consent prior to starting the study medication.
757980|NCT00182000||33 participants enrolled in the study. However, 4 participants decided not to participate in between consenting and starting treatment.
757981|NCT00181961||
757982|NCT00181883||
757983|NCT00181844||
757984|NCT00181766|"Subjects were from referrals to the Adult ADHD Program at the MGH and through advertisements in the local media. The majority of subjects referred to our program first participate in our general screening protocol entitled, A Screening Protocol for Adults with Attention Deficit Hyperactivity Disorder (Protocol # 2002-P-001856)."|
757985|NCT00181714||
757986|NCT00181623|2005-2008 Academic Hospital, clinical research center|
757987|NCT00181610|2004-2008 Academic Hospital, clinical research center|
757988|NCT00181363||
757989|NCT00181285||
757990|NCT00181207||
757991|NCT00181168||
757992|NCT00181155|Participants with Non-Ischemic Cardiomyopathy were recruited as approved by the Johns Hopkins Institutional Review Board for Human Investigation.|The study drug allocation was randomized in a 4:1 fashion by the research pharmacy. Participants were randomized to Placebo only for the purposes of blinding; Adverse Events were collected for the Placebo arm.
757993|NCT00180713||
757994|NCT00180687||
757995|NCT00180674||A total of 14 patients were enrolled in the study. Ten patients completed the study. Four patients withdrew from the study, all during the Phase 1 Observation Period due to personal reasons. These 4 patients did not participate in Phase 2, Treatment Period and they are not included in the analyses.
757996|NCT00180661||
757997|NCT00180479|1002 subjects were recruited at 65 sites. Eligible subjects invited to participate either in-hospital or in-clinic prior to first procedure and required to provide signed informed consent prior to enrollment. Final eligibility based on angiogram before the intended procedure. Dates of recruitment: 6/22/05 through 3/15/06.|Subjects were randomized via telephone randomization and stratified by single and dual lesion/vessel treatment, diabetes mellitus status, and study sites. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.
757998|NCT00180323||
757999|NCT00180271|The study enrolled 1820 patients from 110 hospital centers (88 in the United States, 2 in Canada, and 20 in Europe) between December 22, 2004 and April 23, 2008. Follow-up continued thereafter until trial termination.|Data from all patients enrolled were analyzed on an intention-to-treat basis.
758000|NCT00179998||
758001|NCT00179959|Patients were recruited from Children's Memorial Hospital's pediatric dermatology clinic.|
758002|NCT00179673||
758003|NCT00179660||
758004|NCT00179647||
758005|NCT00179621||A total of 263 potential participants were screened. Potentially protocol-eligible participants were then entered into the Pre-Randomization Phase (up to 56 days) to ensure eligibility criteria were met prior to entering the Double-Blind Phase. A total of 205 participants were randomized into the study.
758006|NCT00179517||
758007|NCT00179478|Participants in the CHAMPIONS 5 year extension study were offered participation in the 10 year extension if their study site participated in the 10 year extension. Study arms were already establish at the onset of CHAMPIONS 10 extension|
758008|NCT00179413||
758009|NCT00179309||Crossover was allowed so that patients randomized to B could receive the vaccine upon progression.
758010|NCT00179127||Original data cannot be found. PI has left Vanderbilt and does not know where records are located. Total enrollment and completion date was obtained from Institutional Review Board records.
758011|NCT00179010|Subjects were recruited through mass e-mails and flyers posted in campus|Subjects were randomly assigned to each treatment arm, after being screened for any medical problem that would be considered a contraindication for the study according to the physician performing the initial evaluation. Once subjects completed one arm, they were crossed to the other arm and studied at lest one month after.
758012|NCT00178919||
758013|NCT00178841||
758014|NCT00178711|Patients were enrolled in hospitals of University of Texas Health Science Center at Houston, University of Calgary, University of Pittsburgh, St. Louis University, Charleston Area Medical Center, and University of New Mexico.Enrollment occurred from December 2005 to June 2009 with follow-up from June 2006 through December 2009|Enrollment criteria at the first eligibility assessment were ages 16-45, non-penetrating brain injury, and not responsive to instructions. 232 participants met these criteria and also had none of a first set of exclusion criteria. At the second eligibility assessment, 97 patients had none of a second set of exclusion criteria.
758015|NCT00178685|Recruitment began in August 2004 and completed in September 2008. Subjects were consented in the research office.|
758016|NCT00178633|IRB Approved to begin recruitment, 5.20.2004. Enrollment ended June 2006. All patients recruited from University of Texas Houston, Bariatric Surgery Center.|
758017|NCT00178503|Participants were recruited from January of 2006 to March of 2010. Sources of recruitment included our UT Department of Psychiatry Clinics, research registry, along with community referrals from local agencies, parent groups, and schools.|129 children completed the initial psychological/screening assessment to confirm study eligibility. Of those 129 children, 94 children met full inclusion/exclusion criteria for the initial phase project. Of these, 28 were invited to participate in the MPH trial and 24 of these children were randomized into the trial.
758018|NCT00178477|Subjects will be identified from patients seen in the Department of Radiation Oncology and who have previously consented to participate in URCC 8700 or URCC 9700.|
758019|NCT00178464||
758020|NCT00178399||
758026|NCT00177866|No results or publication, data destroyed due to age of study. Enrollment number retrieved from old IRB database and not from study records and cannot be verified.|No results or publication, data destroyed due to age of study.
758027|NCT00177671|220 signed consent; 158 participants completed pre-randomization testing; 130 participants were randomized. Of these 130, 67 randomized to donepezil augmentation and 63 to placebo.|28 enrolled participants were not randomized due to the following reasons: dementia (19), consent withdrawal (4), con-compliance with research procedures (3), supervening medical problems that precluded participation (2).
758028|NCT00177307||A total of 40 patients were enrolled, but one subject withdrew before starting therapy.
758029|NCT00177294|Participants were recruited from primary care and specialty mental-health clinics. 377 participants signed consent; 319 started study treatment; 124 were randomized. Of the 124 participants, 60 were randomized to Interpersonal Psychotherapy (IPT) and 59 randomized to Depression Care Management(DCM) without IPT.|67 enrolled participants were not randomized due to the following reasons: consent withdrawal (41); did not meet eligibility criteria (16); supervening medical problems that precluded participation (4); past history of non-reponse to escitalopram (1); side effects (1).
758030|NCT00177255||
758031|NCT00177216|Recruitment period lasted from 1/1/2002 to 12/1/2007. Subjects were recruited from the general public via tv, newspaper, and radio advertisements and via mass mailings.|Subjects who did not meet DSM-IV criteria for primary insomnia, had apnea or periodic limb movement disorder, or had an exclusionary psychiatric diagnosis (generalized anxiety disorder, major depressive disorder, substance abuse) were excluded.
758032|NCT00177164||
758033|NCT00176917||
758034|NCT00176904||
758035|NCT00176891||
758036|NCT00176878||
758037|NCT00176865||
758038|NCT00176852||
758039|NCT00176839|The study was offered to patients at the time different treatment options were being discussed in the clinic or in the hospital.|
758040|NCT00176826|Subjects were recruited from the clinic or hospital where they were being seen for their disease. The study was discussed with them at the time that treatment options were being presented.|Patients had to have a suitable donor identified prior to the subject starting the conditioning regimen.
758041|NCT00176800||
758042|NCT00176644|Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and 4 community hospitals within the Cancer Institute of New Jersey Oncology Group from May 2005 through April 2008.|
758043|NCT00176631|Ten subjects were enrolled from April 2004 through November 2006 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center, and one of its affiliate hospitals within the CINJ Oncology Group.|
758044|NCT00176605|Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center at an academic institution) and Robert Wood Johnson University Hospital at Hamilton (a community hospital) from August 2005 through May 2008.|
758045|NCT00176501|Three subjects were enrolled from March 2005 through February 2006 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center.|
758046|NCT00176488|Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) from June 2003 through May 2009.|
758047|NCT00176462|59 patients with ALL were enrolled between March, 2001 and September, 2005 at the Cancer Institute of New Jersey (outpatient clinical research facility) and 1 patient was enrolled at Jersey Shore University Medical Center (a community hospital).|
758048|NCT00176436|Recruitment took place from 2004 until March, 2008. Participants were recruited from the Maryland Psychiatric Research Center Outpatient Research Program and local community mental health centers.|There was a 2-week evaluation period during which time a diet and exercise program was implemented. All participants then began the double-blind treatment phase of the study. No participants were excluded unless the were taking an excluded medication. 40 participants were enrolled into active participation; 37 participants started treatment.
758049|NCT00176423||"The number of people who signed informed consent was 117. Thirty-one participants who signed informed consent did not complete the Evaluation Phase of the study and were not randomized. Eight-six (86) participants completed the Evaluation Phase of the study and were randomized."
758050|NCT00176306||
758051|NCT00176254|Dates of Recruitment: July 2000-May 2002. All patients were recruited from University of Kentucky Markey Cancer Center|
758052|NCT00176228|In the University of Illinois. The duration of the trial is 14 weeks, with initial 8 weeks of dose titration, followed by 6 weeks of administering the full dose.|To participate, subjects were required to consent to being washed out of their current medications at study entry. The washout period consisted of tapering their previous medications over one week prior to study entry except for those who received aripiprazole or fluoxetine who required a 4-week washout period.
758053|NCT00176202|Dates of recruitment :From Sep2005 - Jan 2008.in Clinic Subjects enrolled:65|"Exclusion Criteria:
~Children with general medical condition such as head injury, epilepsy, endocrine disorders
~Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings."
758054|NCT00175916|The study started to enroll patients in September 2005 and concluded in May 2019.|Participants Flow refers to the Safety Set (SS).
758055|NCT00175877|"Enrollment of subjects started in June 2005. 121 centers in 22 countries enrolled subjects.
~Participant Flow refers to the Safety Set consisting of all enrolled subjects who received at least 1 dose of study medication.
~Of the 857 enrolled subjects, 846 subjects are included in the Safety Set. There was 1 enrolled subject who was never dosed."|"The study consists of 2 populations: of subjects who failed to achieve predefined criteria in preceding study NCT00152386 who entered C87028 on Week 16 of preceding study and of those who completed Week 52 of preceding study.
~Due to findings of fraud at one site, data of the 10 subjects of the site were not analyzed with data from other sites."
758056|NCT00175825|The study started to enroll patients in November 2005 and concluded in June 2006.|Participant Flow refers to the Intention-to-treat (ITT) Set. 210 subjects were initially randomized, 2 subjects discontinued due to Lost to Follow-Up before first study drug intake.
758135|NCT00163189||The reason 'Study Terminated by Sponsor' mentioned in the participant flow indicates the termination of study at a site (due to Good Clinical Practice [GCP] compliance issues) and does not reflect the overall status of study.
758057|NCT00175019|Subjects were enrolled at 174 investigative sites, including 168 in the United States and 6 in Canada, from 28 July 2003 to 26 February 2007.|Subjects were to have completed either 28 weeks or 52 weeks of double-blind dosing in Study C02-009 (NCT00174915) or C02-010 (NCT00102440), respectively before enrollment.
758058|NCT00175006|Subjects were enrolled at 2 study sites in the United States from 19 November 2002 to 09 January 2003.|
758059|NCT00174967|Subjects were enrolled at 24 investigative sites from 31 January 2001 to 9 July 2001|Participants currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollemnt in once daily (QD) treatment groups. All other subjects also initiated prophylactic medications.
758060|NCT00174954|Subjects were enrolled at 6 study centers from 07 March 2002 to 28 January 2003.|Subjects with palpable gouty tophi in select anatomical sites underwent pre- and post-contrast Magnetic Resonance Imaging (MRI)
758061|NCT00174941|Subjects were enrolled at 23 investigational sites in the United States from 21 March 2001 to 29 December 2006|Subjects were to have completed 4 weeks of double-blind dosing in Study TMX-00-004 (NCT00174967) before enrollment in once daily (QD) treatment groups. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.
758062|NCT00174915|Subjects were enrolled at 167 investigative sites in the United States from 21 February 2003 to 07 April 2004.|Subjects currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollment in once daily (QD) treatment groups.
758063|NCT00174785|Enrollment of patients started on June 29, 2005 and was completed on December 30, 2006. The study was conducted at 551 centers in 37 countries. The common study end date ensuring a minimum planned follow-up of one year was December 30th, 2007.|
758064|NCT00174460||
758065|NCT00174447||
758066|NCT00174382|Study was conducted in Canada in 30 centres.|
758067|NCT00174291|Participants included in previous study CTN 97-8129-016 were eligible for this study.|
758068|NCT00174265||
758069|NCT00174252||
758070|NCT00174187||
758071|NCT00172185|10Jan2005 - First Subject Enrolled 24Jan2008 - Last Subject Completed|This was a 28-week study of the safety and efficacy of teduglutide in subjects with parenteral nutrition-dependent short bowel syndrome who completed protocol CL0600-004
758072|NCT00172042||
758073|NCT00171925||
758074|NCT00171873||
758075|NCT00171834||
758076|NCT00171704||
758077|NCT00171340||
758078|NCT00171314||
758079|NCT00171301|This is an Extension to Core Study CICL670A2402 (NCT00171171). 233 participants completed the core study and entered this extension study.|2 participants from the 16 and older group did not receive deferasirox. Thus, the 16 and older group comprises of 69 treated participants.
758080|NCT00171210|This study is an extension of core study (NCT0061750). 555 participants were treated with Deferasirox (ICL670) in the core and/or extension study. In the core study, 296 participants were treated with ICL670 and 259 participants were treated with Deferoxamine(DFO).|
758081|NCT00171054||
758082|NCT00170950||
758083|NCT00170846||
758084|NCT00170625|Recruitment period: 2.6.2004 - 30.8.2005|2 patients missed the inclusion criteria
758085|NCT00170157|112 participants were recruited between June 2004 and June 2009 at Mayo Clinic.|All participants were initially randomized to either arm.
758086|NCT00169442||
758087|NCT00169104|Patients were enrolled between July 12, 2002 and November 2, 2007 from the Comprehensive Breast Program at the Norris Cotton Cancer Center.|There was no run-in prior to randomization and the start of treatment.
758088|NCT00168844|Feb 2003 - Jun 2004, hospital and primary care clinics|
758089|NCT00168831||
758090|NCT00168818|The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 28 - 35 days. The study period is from first administration of study medication until day 84 - 91.|Whilst 3494 patients were enrolled/randomised to treatment prior to surgery in this trial, only 3463 started treatment. Therefore, 31 patients were randomised but not treated (treatment was planned to start post surgery).
758091|NCT00168805|The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 8 days. The study period is from first administration of study medication until day 84 - 91.|Whilst 2101 patients were enrolled/randomised to treatment prior to surgery in this trial, only 2076 started treatment. Therefore, 25 patients were randomised but not treated (treatment was planned to start post surgery).
758092|NCT00168454||
758093|NCT00168428||
758094|NCT00168389||
758095|NCT00168337||
758096|NCT00168324||Patients were randomly assigned during the double-blind period of the study to treatment with 700 µg dexamethasone, 350 µg dexamethasone, or sham injection on Day 0. Patients who qualified to continue in the open-label period of the study received 700 µg dexamethasone on Day 180.
758097|NCT00168311|A total of 20 patients were randomly assigned. Patients were recruited from the outpatient department of two public area mental health services and by referral from a number of private psychiatrists between January 2003 and July 2007.|
758098|NCT00168298||Patients were randomly assigned during the double-blind period of the study to treatment with 700 µg dexamethasone, 350 µg dexamethasone, or sham injection on Day 0. Patients who qualified to continue in the open-label period of the study received 700 µg dexamethasone on Day 180.
758099|NCT00168103|This was a multinational study enrolling subjects at 36 study centers in 15 countries.|"A screening visit was performed before the subject presented with an hereditary angioedema (HAE) attack at the study center. Study entry was defined to occur with administration of study treatment.
~One subject enrolled received study treatment without being randomized and is listed separately in the participant flow."
758100|NCT00168064||
758101|NCT00168038|The study was performed as a multicenter study at 17 centers, 6 in Poland, 4 in the Ukraine, 4 in Russia, 1 in Germany, 1 in Italy and 1 in the United Kingdom (UK).|One enrolled subject was withdrawn prior to receiving treatment due to a non-fatal adverse event. This subject was not included in the analyses.
758102|NCT00167934||
758103|NCT00167778|"Recruitment for this study was conducted at the VA Puget Sound Health Care System (Seattle VA hospital). Recruitment began on May 18, 2006. The study was closed to enrollment on April 24, 2008.
~Data was not collected on the order in which participants received each study intervention."|The prostheses used in this study were built and aligned by a certified and licensed prosthetist prior to beginning starting the protocol. 12 individuals provided informed consent. 1 withdrew prior to starting for personal reasons. 1 withdrew due to unrelated back pain after being fit with both study prostheses and starting with the rigid pylon.
758104|NCT00167661||
758105|NCT00167544|All extremely low birth weight infants (ELBW; birth weight <=1000g) that were mechanically ventilated between day of life 10 to 21 were screened for eligibility in the neonatal intensive care unit at Children's Memorial Hermann Hospital during the period of October 11, 2005 and September 8, 2008.|Parent/guardian was approached if infant's respiratory index score (mean airway pressure x FiO2) was ≥ 2.0 and stable or increasing or if the respiratory index score was ≥ 3.0 when improvement was noted in the previous 24 hour period.
758106|NCT00167414||
758107|NCT00167388|recruitment is completed|
758108|NCT00167310||
758109|NCT00167245|Recruitment for this study began on 11/1/2004 and ended five years later in November 2009. Participants were treatment-seeking cocaine and alcohol users recruited at the UPenn Treatment Research Center.|
758110|NCT00167206||
758111|NCT00167180||During the recruitment period of the study, the donor lymphocyte infusion (DLI) was reduced from 1.0 x 10^8 CD3+ T-cells/kg to 0.5 x 10^8 CD3+ T-cells/kg due to an excess rate and intensity of graft vs. host disease.
758112|NCT00167102||
758113|NCT00166712|All patients were approached in the transplant clinic a Northwestern Memorial Hospital. Recruitment began April 2005 and ended April 2009.|Before being randomized (assigned to group) into Group 1 or Group 2, patients were screened based on inclusion/exclusion criteria (see Eligibility Criteria section). Randomization was decided before transplant surgery. Before re-randomization could begin (6 months after surgery), subjects could not be showing signs of organ rejection.
758114|NCT00166517|"The study was conducted at 8 sites.in Korea from 02-Aug-2005 (first patient in) to 25-May-2006 (last dose
~given). Last subject completed follow-up: 05-Jul-2006. All data corrections applied (Frozen File) on 18-
~Aug-2006"|"Subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of
~known prior rotavirus disease; ongoing chronic diarrhea or failure to thrive and those with clinical evidence
~of active gastrointestinal illness were excluded."
758115|NCT00166504||After a 4-week diet/wash-out period, patients still at or above drug treatment thresholds established by National Cholesterol Education Program Adult Treatment Panel III Guidelines were randomized. Randomization was stratified according to LDL-C levels obtained 1 week pre-randomization: ≥130 to <160 mg/dL; ≥160 to <190 mg/dL; ≥190 mg/dL.
758116|NCT00166439||
758117|NCT00166361|Patients were recruited from Oncologic practice of the Mayo Clinic, Rochester, Minnesota from February 2004 to May 2011.|29 subjects were enrolled, 4 subjects were screen failures, and were not treated, one subject was treated as a compassionate use patient with a smaller memokath stent.
758118|NCT00166296|Participants were recruited among chronic hepatitis C patients between 18 and 65 years old, referred by general practitioners between March 2005 and July 2006 to gastroenterology outpatient units in 15 academic general hospitals in Spain, who were suitable to initiate treatment with pegylated interferonalfa-2a and ribavirin.|
758119|NCT00166205|This study was conducted at twelve U.S. sites representative of the intended use of the SAGB in terms of both the subject population and the medical community. Subjects were recruited from a wide, heterogeneous subject population. Dates of recruitment June, 2003 to November, 2003.|405 Subjects were consented. 129 did not meet screening criteria. 276 subjects were enrolled and received the SAGB device.
758120|NCT00166166||
758121|NCT00166114|Subjects recruited from Emory Psychiatry Clinic outpatient population|
758122|NCT00166036||Previous statin or other lipid lowering medications will be discontinued for 2 months. Subjects will be on stable medical therapy for at least 2 months before recruitment.
758123|NCT00165984||
758124|NCT00165958|subjects older than 18 years of age with 1-3 cm truncal EICs were selected via serial recruitment from the Atlanta Veterans Affairs Medical Center Dermatology clinic|Patients were excluded if the cysts were inflamed, infected, or ruptured based on characteristic physical examination findings.
758125|NCT00165841|This study was recruited at 47 centers in the US during the period of 7-Oct-2004 and 12-Dec-2005.|After enrollment and before randomization (treatment assignment), there was a 2-week placebo run-in phase followed by a 4-week open-label Acute Phase during which subjects were treated with rabeprazole 20 mg once daily for the treatment of heartburn. Note the below participant flow is based on Safety Population (total 200 subjects).
758126|NCT00165789||
758127|NCT00165776|130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.|
758128|NCT00165698||
758129|NCT00165672|This study was recruited at 13 centers in Japan during the period of May-2005 to Oct-2005.|Antacid was administered 1-2 weeks for observational period (non-blind). Patients showing the resistance to antacid and patients for whom percent time with pH <4.0 >0% during the 24 hour esophageal pH monitoring at the end of the observation period.
758130|NCT00165646|This study was recruited at 35 centers in Japan during the period of Sep-2004 to Oct-2005.|Antacid was administered 1-2 weeks for observational period (non-blind). Patients showing the resistance to antacid were transferred to treatment period (randomized double-blind) of placebo, E3810 5 or 10 mg/day for four weeks.
758131|NCT00165503||
758132|NCT00163657|Recruitment period August 15, 2002-March 29, 2004 Recruitment of liver transplant receipeints from centers transplant program|Subjects must be receiving a liver transplant for end stage chronic HCV
758133|NCT00163293|Participants took part in the study at 30 investigative sites in Canada, Hungary and South Africa from 24 January 2005 to 25 June 2009.|Children who experienced symptoms consistent with mild asthma for at least 12 months were enrolled in 1 of 3 treatment groups: once a day placebo, 100 µg or 200 µg ciclesonide.
758134|NCT00163215||
758136|NCT00163020|Potential women carrying a twin or triplet pregnancy meeting defined inclusion and exclusion criteria were recruited from participating outpatient medical clinics from November, 2004 to August 2009.|During the pre-assignment period, subjects were consented to participate, giving a compliance injection of Castor Oil and brought back 5 to 9 days later for re-evaluation. Exclusions were made based on the presence of a reaction to the injection, not meeting inclusion/exclusion criteria or the participates desire not to participate.
758137|NCT00162981||
758138|NCT00162942||
758139|NCT00162773||The arms/groups were combined for the study due to the study's early termination and the PI's departure from the institution. Data obtained were from the IRB and are therefore not separated by arm. This is all that is available.
758140|NCT00162370||
758141|NCT00162266||Of 524 subjects who were enrolled in this study, 185 were not randomized (1 reason unknown; 2 adverse event; 9 withdrawal of consent; 160 failure to meet inclusion and/or exclusion criteria; 1 death; 12 for other reasons).
758142|NCT00162136||A total of 39 participants enrolled and 4 participants were never treated (2 reported serious adverse events [SAEs] prior to the first dose of study medication and were never treated; 1 had rapid decline in performance status and died prior to the first dose of study medication; no reason was given for the remaining participant).
758143|NCT00162123||Of 248 enrolled, 6 failed screening; 28 from study CA184-004 (NCT00261365), 42 from CA184-007 (NCT00135408), 67 from CA184-008 (NCT00289627), and 103 from CA184-022 (NCT00289640) entered CA184-025 (NCT00162123). Of enrollees, 2 from study MDX010-08 (NCT00050102) and 6 from MDX010-15 (NCT00729950) entered maintenance as Tumor Assessment Only.
758144|NCT00162097||21 participants were enrolled in the study; 5 discontinued prior to study drug administration (1 adverse event, 1 enrollment completed, 1 screen failure, 1 no longer met study criteria and 1 withdrew consent).
758145|NCT00162032||
758146|NCT00161616|Patients were recruited worldwide from September 2003 to July 2007.|Assessment of the fractured limb was performed 24 hours before surgical fixation. Patients were stratified by severity of fracture (using Gustilo-Anderson Classification).
758147|NCT00161473||
758148|NCT00161382||Of the 3,007 participants who were recruited for the study, 371 were excluded because of limited English proficiency and 1,191 were excluded because they did not obtain parental affirmative consent. Thus, 1,445 participants were randomized to either the comparison (n = 847) or the intervention (n = 598) condition.
758149|NCT00161213|The recruitment period spanned from October 2005 through July 2009. The trial was opened at a single regional cancer center and then expanded to other centers to reach accrual goals within the target period. These included hospitals in the CINJ Oncology Group and Northwestern University's Robert H. Lurie Comprehensive Cancer Center.|
758150|NCT00160706|"This multicenter study started to enroll subjects in February 2004 in order to end up with 141 centers in 24 countries with enrolled subjects.
~Participant Flow refers to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425]."|Subjects who withdrew from feeder studies for worsening of Crohn's Disease entered study C87034. Subjects in study C87031 were eligible for entry into C87034 at any time after completing the Week 2 assessment, subjects in study C87032 at any time after completing the Week 6 randomisation.
758151|NCT00160693|"Subjects must have participated in CZP trial C87011 [NCT00548834] or C87014 [NCT00544154] for at least 12 weeks to be eligible to enter the study.
~All enrolled subjects who received at least one dose of study medication are included in the Safety Set (SS)."|Participant Flow and Baseline Characteristics refer to the Safety Set (SS). Baseline Characteristics were measured at Baseline of the respective feeder study.
758152|NCT00160680|The study started to enroll patients in March 2005 and concluded in June 2006.|Participant Flow refers to the Randomized Set.
758153|NCT00160667|The study started to enroll patients in October 2004 and concluded in January 2006.|Participant Flow refers to the Randomized Set.
758154|NCT00160654|The study started to enroll patients in November 2003 and concluded in May 2006.|Participant Flow refers to the Intend-to-treat (ITT) Set.
758155|NCT00160641|Enrollment started in December 2005. 67 centers in 13 countries enrolled subjects. Participant Flow refers to the Safety Set (SS) consisting of all enrolled subjects who received at least 1 dose of study medication. Due to fraud findings at 1 site, data of the 15 subjects of site were not analyzed with data from all other sites and not part of SS.|"This Open-label Study consists of two different populations:
~of those subjects who failed to achieve predefined criteria in preceding study C87050 [NCT00160602] who entered C87051 on Week 16 of the preceding study and of those who completed the Week 24 assessment of the preceding study."
758156|NCT00160615|The study started to enroll patients in September 2001 and concluded in January 2007.|Participant Flow refers to the Full Analysis Set (FAS). Of the 154 subjects who enrolled in the study, 151 subjects were included in the FAS population and 3 subjects were identified with major protocol deviations leading to exclusion from FAS.
758157|NCT00160563|This study is a 18-month prolongation study to study A00309 (EPAAC study - NCT00152464) and was prematurely terminated due to the fact that the primary endpoint in study A00309 - NCT00152464 was not met.|In total, 207 subjects from study A00309 - NCT00152464 entered this prolongation study. Participants Flow and Baseline Characteristics sections show patients as randomized. One patient (016/1709) received LCTZ instead of PLC in the PLC-PLC arm erroneously and is described separately in the Adverse Event section.
758158|NCT00160524|"This multicenter study started to enroll subjects in July 2004 in order to end up with 206 centers in 29 countries with enrolled subjects.
~Participant Flow refers to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425]."|All subjects who completed the Week 26 assessment in feeder studies C87031 and C87032 were eligible to enter this open-label follow-on study C87033.
758159|NCT00160251||
758160|NCT00160199|Subjects were recruited in 42 centers in US between November 2004 and February 2009. Before the randomization, subjects were evaluated for eligibility. In total 240 subjects were randomized.|The Baseline characteristics are presented using the Full Analysis Sample (FAS) to be online with the Efficacy analysis results.
758221|NCT00152464|The study started to enroll patients in March 2002 and concluded in March 2006.|Participant Flow refers to the Intent-to-treat (ITT) population. 514 subjects were initially randomized, 4 subjects withdrew consent before first study drug intake.
758161|NCT00159965|Patients were referred to the Rhode Island Hospital (RIH) neuropsychiatry/behavioral neurology clinic between July 2002 and June 2008, after being diagnosed with psychogenic nonepileptic seizures (PNES). PNES diagnosis was established by capturing at least one of the patient's typical PNES on video electroencephalogram (vEEG).|
758162|NCT00159913|The study was conducted at 32 centers in North, Latin and South America, Europe and Asia.|Of the 324 subjects screened, 235 subjects were randomized. 234 received treatment. One subject(sildenafil medium dose group) withdrew prior to taking any study treatment as the hemodynamic entrance criteria were not met.
758163|NCT00159874|This extension study included 220 participants at 31 sites. 14 participants did not go from A1481131 (NCT00159913) to A1481156. Participants from one center in Canada participated in base study A1481131 (NCT00159913) but not in this extension study.|Participants remained in the same dose group as in study A1481131 (NCT00159913). Participants randomized to placebo in NCT00159913 were rerandomized to sildenafil in A1481156. Placebo participants in low weight category were rerandomized to medium or high dose (1:2) and other weight categories were rerandomized to low, medium or high dose (1:1:1).
758164|NCT00159861||Subjects were entered into the open-label extension study portion upon completion of the preceding 16-week, placebo controlled core study portion or, for subjects who required a change in epoprostenol dose due to clinical deterioration, after at least 4 weeks in the core study portion.
758165|NCT00159822|18 active centers in France; planned recruitment of 48 minimally immunocompromised or non-immunocompromised subjects with chronic bronchopulmonary aspergillosis.|56 subjects were screened; 48 subjects included; 8 subjects did not meet criteria and were not included.
758166|NCT00159783||
758167|NCT00159432|Recruitment for this trial opened in February 2005 and closed in May 2009. All subjects were seen at USC.|This trial has no pre-assignment. All subjects were given the same treatment.
758168|NCT00159419|Recruited from clinics|
758169|NCT00159263|10patient recruited mild asthma|
758170|NCT00159250||
758171|NCT00158925||
758172|NCT00158860|The study was conducted in 74 centers in the Unites States, Canada, Argentina, Brazil, and Chile.|A total of 384 participants with first recognized episode of genital herpes (GH) were randomized in this study, out of which one participant did not take the study medication, hence, the Intent-to-treat (ITT) population consisted of 383 participants.
758173|NCT00158756||
758174|NCT00158743||
758175|NCT00158600||One hundred patients screened and 90 enrolled.
758176|NCT00158379|recruitment period: July 2003 - December 2004|
758177|NCT00158262||Participants who experienced a qualifying acute psychological trauma were randomized to receive up to 240 mg/day of propranolol or placebo.
758178|NCT00158249||
758179|NCT00158223|Subjects recruited from inpatient and outpatient treatment settings at Mount Sinai Hospital, Pilgrim Psychiatric Center and Manhattan Psychiatric Center in New York.|16 subjects were excluded during the 4-week symptom stability-screening period before randomization because of withdrawal of consent or a failure to meet inclusion and exclusion criteria. Seven additional subjects were randomized to a haloperidol adjunctive pilot study.
758180|NCT00158197|Recruitment and enrollment began in January 2005 and ended . Individuals were recruited from the community via radio and newspaper ads, flyers, and word of mouth.|The main reasons individuals were excluded from the trial prior to group assignment was not meeting inclusion criteria and discontinuing treatment prior to randomization.
758181|NCT00158184||
758182|NCT00158054|Participants were recruited at 5 hospital sites (Mount Sinai Hospital and New York Presbyterian Hospital, New York, New York; and New Haven Hospital, Hospital of St Raphael, and Veterans Affairs Connecticut Healthcare System-West Haven, New Haven, Connecticut) from January 1, 2005, through February 29, 2008.|
758183|NCT00157950|"Patients were recruited at 10 medical sites in Korea.
~First Patient Treated: 20-Oct-2005
~Last Patient Treated: 24-Jun-2006"|A serum or urine pregnancy test was performed prior to each injection on all subjects. Results were available prior to vaccination. Any subject with a positive pregnancy test at Day 1 was not randomized or vaccinated, and was not eligible to continue in the study.
758184|NCT00157820|Patients were eligible if they met a standard Class I indication for a Single Chamber-Implantable Cardioverter Defibrillator (ICD) according to the 1998 ACC/AHA guidelines. Every patient eligible for ICD was screened at each study centre. Follow-up started immediately after randomization.|"The Dual chamber true (DC true) and Single chamber simulated (SC sim) arms crossed over after 8 months. All other crossovers were considered 'premature crossovers' and had to be authorized by an independent Adverse Events Advisory Committee.
~A 1-month wash out period was implemented after programmed crossover."
758185|NCT00157755||
758186|NCT00157573|Granulocyte macrophage colony-stimulating factor (GM-CSF) Phase II recruitment from oncology clinic.|Phase II
758187|NCT00157248|This was a non-randomized open-label extension study of study 1160.20. Patients initially continued Dabigatran treatment of 1160.20; per protocol amendment, most patients moved to 150 mg bid. All events were assigned to the Dabigatran regimen that a patient received prior to the event and patients may be counted in multiple regimens|In this non-randomized follow-up study, events are displayed cumulatively that occurred in the initial study (1160.20) or in the present study.
758188|NCT00157209|First/Last participant (informed consent): 08 August 2000/02 December 2002. Clinical data cut-off: 15 March 2006. Participants randomized at 17 centers in Canada and United Kingdom.|A total of 437 participants were screened for eligibility and 171 participants were randomized.
758189|NCT00157196|First/last participant (informed consent): April 2005/September 2005. Last participant completed: April 2012; Clinical data cut-off: 17 September 2007. The study was conducted at 8 centers in Canada.|Enrolled: 22 participants.
758190|NCT00157157|Recruitment was conducted in the U.S., Canada, and Europe at 24 study sites.|Participants screened for maximum 21 days. Study was not randomized; it was an open-label evaluation. Prior to initial infusion, a minimum washout period of 3 days was required. 11 participants who enrolled did not receive any rAHF-PFM infusions (3 withdrew consent, 6 screen failures, 1 non-compliance with screening, 1 pre-existing low hemoglobin)
758191|NCT00157014|"3 patients randomized to cyclosporine actually received tacrolimus and were included in the Treatment Exposure Population for tacrolimus.
~2 patients randomized for tacrolimus were excluded from Treatment Exposure Population - 1 never received drug; 1 received incorrect drug without a waiver."|
758192|NCT00156936|Recruitment was conducted at 17 clinical trial study centers in the United States.|Investigators ensured subjects were opioid-free (ie, had opioid-free urine screening results) prior to initiation of study therapy. For subjects diagnosed with opioid dependence or in whom clinically significant opioid use was suspected, a naloxone challenge test was performed.
758193|NCT00156923|Subjects who successfully completed Alkermes' Study ALK21-003EXT (NCT01218971) and who continued to meet eligibility criteria were given the option to enroll into this extension study.|
758194|NCT00156910||
758195|NCT00156819||
758196|NCT00156715|Participants were recruited from two urban study sites, one in New England, the other in the Southeast, primarily through clinician referral, over two years. All participants gave informed consent.|Prior to starting quetiapine, all participants first completed a screening assessment to establish diagnosis, amount of alcohol (and other drugs) consumed, and current medications and medical status. This data was used to characterize the group and assess whether they met eligibility criteria for the study.
758197|NCT00156533|Subjects recruited from television and newspaper ads. After a telephone or web based screening, subjects brought into the lab to read the Informed Consent Form (ICF). After the ICF has been signed, an initial medical and psychiatric evaluation completed. If the subjects remain eligible they are required to keep two weeks of sleep diaries.|
758198|NCT00156390||
758199|NCT00156247||
758200|NCT00156065||Note that one participant in each of the Placebo/Asenapine and Asenapine/Asenapine groups was enrolled but did not receive treatment. Thus, the numbers who started the period will be greater than the numbers presented at baseline and for analysis.
758201|NCT00156013||
758202|NCT00154466|This prospective randomised controlled study was approved by the ethics committee of the National Taiwan University Hospital. Between August 2004 and December 2005, 91 postinfarction patients were informed about the trial. Thirty-seven refused to participate and 15 did not meet the inclusion criteria.|Inclusion criteria:a successful primary stenting, a clinically stable course after MI, and no ischemia on exercise testing. Exclusion criteria: effort angina, Af, sustained ventricular arrhythmia, NYHA functional class IV, exercise-limiting diseases, severe pulmonary or renal disease, an implanted pacemaker, or claustrophobia.
758203|NCT00154375||
758204|NCT00154310|This study was an open-label, randomized, parallel-group, multi-center study with two treatment groups, cyclosporine continuation and cyclosporine withdrawal starting from Month 4.5 post-transplant. Study started in June 2005 and ended in September 2008.|
758205|NCT00154297||
758206|NCT00154284|Subjects were recruited from Spain from July 2005 to July 2008. As per protocol amendment, data were analyzed together with data from study CRAD001A2423 (NCT00154284) and CRAD001A2423 (NCT00170807).|
758207|NCT00154102|"First/Last subject in: 10 Aug 2004/4 Nov 2005. Clinical cut-off efficacy analyses except survival: 27 Jul 2006, Cut off date IRC data: 14 Dec 2006; cut-off safety analyses: 30 Nov 2007; cut-off survival analyses: 31 May 2009; cut-off KRAS analyses: 28 Aug 2009.
~1221 subjects were randomised or treated, of whom 1198 were randomised and treated."|"At the prescreening visit the subject completed the first informed consent form, and a sample of tumor tissue for determination of EGFR expression was to be obtained.
~The screening (baseline) visit was performed no more than 21 days before randomization. EGFR-expressing subjects completed a second informed consent form to participate in the study."
758208|NCT00154063||
758209|NCT00153985|Activated for enrollment 3/4/2004. Closed to enrollment 4/25/2008. Participating institutions included: Dana-Farber Cancer Institute, Boston, Massachusetts, Feist-Weiller Cancer Center, LSU Health Sciences Center, Shreveport, Louisiana and Winship Cancer Institute, Emory University, Atlanta, Georgia|All enrolled patients received a stem cell transplant.
758210|NCT00153920|66 participants were enrolled between December 2003 and September 2005.|
758211|NCT00153842||
758212|NCT00153816|Subjects were enrolled between July 2004 and July 2008 at 11 academic medical centers and associated gastroenterology practices in the U.S.|19,083 subjects were screened and 2,813 were enrolled into a run-in period of 56-84 days. 554 subjects were not randomized: 174 were ineligible due to out of range baseline lab values, 66 were ineligible for other reasons, 211 had <80% tablet adherence, and 103 refused to participate.
758213|NCT00153803|Period 1: 245 patients were registered & randomized. Of those, 10 patients were ineligible due to incorrect stage, withdrawal of consent, inability to meet radiation therapy parameters, and inadequate functional status. The number of participants for each specific reason for ineligibility is unknown. They did not receive any study intervention.|Period 2:Study drug dispensed to only chemoradiation patients who did not experience disease progression, consent withdrawal, death, investigators discretion, or toxicity.
758214|NCT00153179||
758215|NCT00153166||
758216|NCT00153101|At the randomization visit, patients who have adhered to the medication regimen (consumed > 75% of ramipril + telmisartan during run-in phase) and were Angiotensin Converting Enzyme (ACE) tolerant were randomized into the main study (ONTARGET). ACE intolerant patients were randomized into the parallel trial (TRANSCEND).|
758217|NCT00153062|Sept 2003 - July 2006; 695 centres in 35 countries|No screening period
758218|NCT00152971|The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 12 - 15 days. The study period is from first administration of study medication until day 84 - 91.|Whilst 2615 patients were enrolled/randomised to treatment post surgery in this trial, only 2596 started treatment. Therefore, 19 patients were randomised but not treated (treatment was planned to start post surgery).
758219|NCT00152763|Recruitment commenced in October 2003 at Toronto General Hospital and St. Michael's Hospital in Toronto, Ontario, Canada and concluded in August 2006.|Upon recruitment, participants completed baseline psychological assessment prior to being randomized to the experimental intervention arm (cognitive behaviour therapy) or usual care.
758220|NCT00152516|102 sites in 17 countries participated in the study, of which 85 sites in 16 countries enrolled subjects in the study. First subject enrolled: 23 October 2004, Last subject last visit: 24 June 2008|Protocol amendment C2 (August 7, 2006) allowed direct enrollment from India, Australia, and New Zealand bypassing the blinded feeder studies N01009 and N01103.
758222|NCT00152009||Subjects were randomized to receive either 2, 3, or 4 mg SPD503 (Guanfacine hydrochloride) or placebo once-daily.
758223|NCT00151996||Dose titration of SPD503 (Guanfacine HCl) for 3 weeks starting at 1 mg/day and increased in 1 mg weekly increments up to 4 mg/day (or to the highest tolerated dose); then dose maintenance for 3 weeks; then downward titration of SPD503 at 1 mg weekly decrements for 3 weeks while maintaining the subject's current psychostimulant dose and frequency.
758224|NCT00151892||
758225|NCT00151814|The recruitment period was from September 2005 to February 2008. This period lasted for this length of time because of difficulties in recruiting participants. Children from 12 months old to 16 years old were to be enrolled.|The 2-5 years old cohort had only 4 participants and their data were not sufficient for meaningful analysis. No participants in the 12-23 month old category were enrolled.
758226|NCT00151775||Period 1 was a screening, wash-out period of approximately two weeks. All participants were included in the screening, wash-out period and during this period no intervention was administered.
758227|NCT00151476|Study prematurely discontinued in May 2008 prior to reaching planned enrollment target; Last subject last visit November 2008.|Familial Adenomatous Polyposis (FAP) identified subjects=celecoxib-treated and matched control subjects eligible for inclusion in study identified from 4 registry sites; FAP analyzed=celecoxib-treated and matched control subjects eligible for matching and analysis in study. 1 subject excluded from analysis; took celecoxib without a prescription.
758228|NCT00151411||
758229|NCT00151372|All subjects were recruited from the Inpatient Pulmonary Rehabilitation Units of the Burke Rehabilitation Hospital and Helen Hayes Rehabilitation Hospital. Recruitment began in March 2002 and ended in January 2008.|
758230|NCT00151320||
758231|NCT00151281||
758232|NCT00150969|recruitment from January 2002 to September 2006 through health fairs, community posters and advertisements.|453 participants signed consent. 13 were not included in analysis(10 screen failure,3 drop out at baseline)
758233|NCT00150813|The study started to enroll patients in August 2005 and concluded in May 2007.|Participant Flow refers to the Intention-to-Treat (ITT) Set.
758234|NCT00150800|The study started to enroll patients in January 2006 and concluded in September 2017. 668 subjects were included in the Enrolled Set but 1 subject from India lost to follow up and was excluded from the Safety Analysis Set due to lack of medical data.|The Participant Flow refers to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug.
758235|NCT00150618||Although 324 subjects were randomized, 2 never received drug and therefore were not included in the Baseline Characteristics. Subjects received either 1, 2, 3, or 4 mg of SPD503 (Guanfacine hydrochloride) or placebo once daily.
758236|NCT00150592||A total of 182 subjects were enrolled. Four (4) subjects were terminated prior to receiving study medication. Thus, 178 were randomized and received study medication.
758237|NCT00150462|Adults with with multiple myeloma (MM)-both secretory and nonsecretory, non-Hodgkin's lymphoma (NHL), Hodgkin's disease (HD), or Waldenström's macroglobulinemia (WM) were eligible for enrollment in this study.|The study was divided into a sequential Dose Escalation phase (Part 1; Arms 1-9), followed by a Dose Expansion phase (Part 2; Arms 10-11) consisting of a carfilzomib-only cohort and a carfilzomib-plus dexamethasone cohort.
758238|NCT00150345|810 participants screened; 81 assigned to immediate voriconazole treatment and 66 to deferred voriconazole treatment. Study should be considered a pilot study; planned sample size (n=200) was not based on statistical power considerations.|Screening phase started with cytoreductive treatment; screening phase ended at onset of fever or if reconstitution of leukocytes to >1000 per microliter (1000/uL) or neutrophils to >500/uL. Randomization occurred within 18 hours after onset of fever (if febrile or had positive polymerase chain reaction (PCR) assay prior to onset of fever).
758239|NCT00150176||Prior to randomization, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). Only subjects who had continued stable presentation of symptoms during this phase were randomized into the double-blind phase.
758240|NCT00149994||
758241|NCT00149890||
758242|NCT00149838||
758243|NCT00149825|Participants were recruited between June 2004 and August 2006 through newspaper advertisements, electronic bulletin boards, community postings, and brochures in clinics.|Enrolled participants were screened to determine if inclusion exclusion criteria were met. This process included structured clinical interviews, completion of sleep logs, and an ambulatory screening sleep study to rule out other sleep disorders.
758244|NCT00149799||A total of 100 participants received open-label escitalopram in Phase I. Only those who completed Phase I, met criteria for response, and were willing to continue on in the study were subsequently randomized in Phase II (n=58).
758245|NCT00149747|Participants recruited through radio and newspaper advertisement, direct mailings to local addresses.|Overnight pulse oximetry for 1 night to rule out sleep apnea
758246|NCT00149669||
758247|NCT00149643|This study was conducted at the Western Psychiatric Institute and Clinic (WPIC) of the University of Pittsburgh Medical Center (UPMC). Subjects were recruited for participation in the treatment study through referrals from any of the WPIC treatment programs and by responding to newspaper, radio, and bus advertisements.|
758248|NCT00149630|The 74 opioid and cocaine dependent subjects were drawn from a sample of 93 candidates who entered into a 2-week screening period for stabilization on methadone maintenance between 2005 and 2006 at Yale University (n=40) and then from between 2006 and 2008 at Baylor College of Medicine (n=53).|Eleven subjects were excluded prior to randomization because they did not have at least one urine toxicology positive for opiates or cocaine metabolites during the two-week screening. Another eight subjects were lost to follow-up prior to randomization.
758249|NCT00149396||
758250|NCT00149227|We recruited patients between January 2004 and June 2007. Participating centres included 31 associated hospitals led by physicians (cardiology specialists) from Kyoto Prefectural University School of Medicine.|Among 3042 patients eligible, 4 patients were withdrawn due to refusal of informed consent, 7 were withdrawn due to incompatible object. Finally, 3031 patients were assigned to the treatment groups.
758251|NCT00149214||The one participant who was randomized to pemetrexed but treated with cyclophosphamide is included in the as randomized group (pemetrexed) for the purposes of the participant flow, excluded from the efficacy analyses (per the protocol), but in the as treated group (cyclophosphamide) for safety analyses.
758252|NCT00148954||
758253|NCT00148941|This study was conducted at 24 centers in the United States.|All 4209 subjects enrolled in the study, received the study vaccination and were included in the Total vaccination cohort (TVC).
758254|NCT00148798|First/last subject (informed consent): October 2004/January 2006. Clinical data cut-off: 18 July 2007. Last subject completed 16 May 2012. Subjects randomized at 155 centers; Asia/Australia: 21; Europe: 120; South America: 14.|Enrolled: 1,861 after consent to epidermal growth factor receptor (EGFR) assessment; 603 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 1,258 screened for eligibility after consent for study procedures; 143 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 1,125 subjects randomized.
758255|NCT00148759|Subjects were recruited from the Grady Infectious Diseases Clinic in Atlanta, Georgia between June 2005 and January 2007. All subjects provided written informed consent before undergoing any study procedures.|Of the 23 subjects enrolled, 20 completed the study including the PK sampling. Three subjects (2 males and 1 female) dropped out. Two subjects were unavailable for the 24-hour PK sampling because of changes in their work schedules, and the third subject was lost to follow-up after the initial study visit.
758256|NCT00148733||
758257|NCT00148668|A total of 81 patients were enrolled on the study between 12/2003 and 8/2008.|
758258|NCT00148343|Subjects screened over 5-yr study period: 469. Subjects completing informed consent and eligibility eval: 158. Subjects enrolled: 110. Last date of enrollment:10/27/2009. Final date subject study completion: 8/2/2010. All subject screening, enrollment, and study participation took place at an academic medical center.|Enrolled subjects (n=110) were stratified by presence or absence of dorsiflexion, based on clinical exam, prior to randomization into treatment and control groups. No enrolled subjects were excluded from the trial prior to assignment to groups.
758259|NCT00148317||
758260|NCT00148122||
758261|NCT00148109|36 subjects were recruited between June of 2005 and June of 2008 in the Comprehensive Cancer Center outpatient Oncology Clinics at the University of Michigan Health Systems|Potential participants who appeared to meet study criteria were approached with a brief discussion of the study. If interested, a more in - depth detail discussion of the risks and benefits of potentially participating in the study took place with the subject as well as any family members that may have been present.
758262|NCT00147966||
758263|NCT00147823|Subjects seen by Dr. Damron in his clinical office were asked to participate, if they met the inclusion/exclusion criteria. Dates of recruitment February 2005, through August 2007|
758264|NCT00147745|Subjects were recruited from 21 June 2005 to 22 January 2008 at 3 clinical research sites in the United States of America.|Subjects were taken off any non-sulfonylurea oral anti-diabetic agents for a period of time appropriate to the drug. Qualified subjects were randomized to colesevelam hydrochloride, placebo, or open-label insulin glargine for 12 weeks. Difficulties enrolling into the insulin group caused the size of this group to decrease from 15 to 6 subjects.
758265|NCT00147537||
758266|NCT00147498||
758267|NCT00147446|Participants were enrolled at MS specialty clinics at three sites in the United States (University of California San Francisco California (UCSF), Evergreen Hospital Medical Center in Seattle Washington and the Feinberg School of Medicine at Northwestern University in Chicago Illinois) and through local chapters of the National MS Society.|
758268|NCT00147316||
758269|NCT00147290||
758270|NCT00147277||
758271|NCT00147238|Recruitment Period: 08/24/05 through 06/12/06. All participants recruited at UT MD Anderson Cancer Center.|A total of 10 patients enrolled prior to sponsor's request for early termination. Only 2 patients were evaluable for response therefore data will not be analyzed due to too small sample size.
758272|NCT00147225|Recruitment Period: 08/04/05 to 04/09/12. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|Of the 55 participants enrolled, one participant was enrolled but was a screen failure and another three withdrew without receiving any study drug thus were excluded from the trial demographics.
758273|NCT00147212|Completed|
758274|NCT00147199|The first subject was enrolled on 7 June 2005 and the last subject exited the study on 12 Oct 2007.|
758275|NCT00147082||
758276|NCT00147069||
758277|NCT00147043|Participants were sequentially recruited to the study from January 2005 to June 2005|
758278|NCT00147030|Infants who met trial entry criteria were recruited at 40 Neonatal Intensive Care Units mainly in the United Kingdom and also in Europe. Recruitment took place over 4 years, from December 2006 to November 2006.|494 infants were assessed for eligibility; 94 did not meet inclusion criteria, 30 declined to participate 45 were not enrolled for other reasons. 325 underwent randomization.
758279|NCT00147017||
758280|NCT00146848|Enrollment began on November 8, 2004, was completed on December 21, 2007, with study follow-up commencing January 30, 2009. This trial was conducted at institutional settings throughout the United States and Australia.|All patients with successful system implants were programmed to DDD-40 (atrial rate support above 40 bpm; limited atrial pacing) for the first 6-weeks of the trial. Randomization (1:1:1 allocation) occurred after patients had reached the 6-week visit and continued to meet all of the eligibility criteria for the trial.
758281|NCT00146770||
758282|NCT00146757||
758283|NCT00146640||
758284|NCT00146328||
758285|NCT00146172||
758286|NCT00145977||
758287|NCT00145795|Patients were enrolled from the outpatient clinics at the University of Chicago and the University of Illinois, with approval from the Institutional Review Board at each institution.|
758288|NCT00145704|Adult pts from Upstate Med Univ who have known growth hormone deficiency as a complication of treatment for pediatric malignancy will be selected after chart review from their Kids Not on Treatment(KNOT)Clinic records prior to their routine follow up appt.Pts will receive info about this study on their routine f/w up appts at the KNOT Clinic.|
758326|NCT00142298|An open-label trial of telbivudine in adults with chronic hepatitis B previously treated in Idenix-sponsored telbivudine studies. Study start March 2005 and completed November 2009.|
758327|NCT00142168|Outpatient clinic at DFCI|Symptomatic WM patients requiring therapy
758328|NCT00142116|Patients with Waldenstrom's Macroglobulinemia|A phase II study using thalidomide and rituximab in symptomatic Waldenstrom's macroglobulinemia (WM) patients naïve to either agent.
758289|NCT00145626|19 participants and 21 stem cell donors were enrolled between October 2006 and June 2011. The study was temporarily closed to accrual in June 2011 due to unavailability of study drug. The study was formally closed March 2015 because of continued unavailability of study drug. The 21 donors are excluded from this report.|19 stem cell recipients were enrolled, and 5 were excluded. Two participants did not have natural killer cell infusions due to donor was unable to donate enough CD34+ cells or CD56+ cells for infusion, 1 participant became ineligible because they turned 2 years old prior to start of therapy, 1 withdrew and 1 expired.
758290|NCT00145600|296 patients were enrolled from 5 institutions between March 2000 and May 2011.|
758291|NCT00145587|OPBMT2 was activated, July 2004. From September, 2004 through February, 2008, six transplant participants, five donors, and four genetic testing participants were recruited and enrolled on the study.|Of the fifteen enrollments, the donors and genetic-testing participants did not receive transplants. Of the six transplant participants, five where eligible for and received a haploidentical hematopoietic stem cell transplant (HSCT) and one received a sibling donor HSCT.
758292|NCT00145574|Study was conducted at 41 clinical sites; Australia (1 site), Austria (1 site), Canada (5 sites), Hungary (1 site), Israel (5 sites), New Zealand (1 site), Norway (2 sites), Slovakia (3 sites), South Africa (4 sites), Czech Republic (3 sites), Netherlands (2 sites), and USA (13 sites). Study initiated November 5, 2005 completed December 18, 2007.|Period I Run-In (4 weeks): Period I was a single-blind stabilization period prior to randomization. All subjects received 6 placebo tablets daily. Objective was to evaluate dosing compliance and tolerability to the tablets prior to randomization. Subjects could be on stable pediatric approved statin regimen and low cholesterol diet for 6 weeks.
758293|NCT00145509||
758294|NCT00145496||
758295|NCT00145470||
758296|NCT00145418|patients recruited from clinical practice.|patients were screened to see if they met eligibility criteria. If criteria met, enrolled into study. Otherwise listed as screen failures.
758297|NCT00145327|This was an international, multicenter, randomized, double-blind 3-year extension study in postmenopausal women with osteoporosis who had completed participation in the CZOL446H2301 (NCT00049829) core study. The extension study started 17 May 2005 (First patient enrolled) and ended 24 Nov 2009 (Last patient completed).|"Patients who were receiving zoledronic acid in the core study were randomized in a 1:1 fashion to receive either zoledronic acid or placebo in the extension study.
~Patients who were receiving placebo in the core study were assigned to zoledronic acid in the extension study in order to retain the core study blind."
758298|NCT00145249|Subjects were screened and enrolled at 10 sites in the US and 5 sites in Thailand.|
758299|NCT00145119||
758300|NCT00145041|This was a single-center, open-label, single-arm, Phase 1 study to assess the PK of VSLI in subjects with malignant melanoma and hepatic dysfunction secondary to liver metastases.|Eligible subjects were to have liver metastases confirmed by computed tomography (CT) scan at screening. Categorization of hepatic dysfunction at screening included Child-Pugh System.
758301|NCT00144963||
758302|NCT00144781||
758303|NCT00144391||
758304|NCT00144339|09 Jan 2003 - 22 Feb 2008; 490 centers in 37 countries|
758305|NCT00144300||
758306|NCT00144170|The discrepancy with enrollment number in the protocol section is due to 16 patients not treated. (7 from TPV/r and 9 from CPI/r). These patients were not included in any analyses or results.|
758307|NCT00144027||
758308|NCT00143845||
758309|NCT00143819||
758310|NCT00143598|Between June, 2004, and February, 2010, we enrolled patients in 24 centres in Canada and the USA.|Patients were excluded if they had a contraindication to the use of compression stockings, an expected life span of <6 months, geographical inaccessibility, were unable to apply stockings, or received thrombolytic therapy for the initial treatment of acute deep vein thrombosis (DVT).
758311|NCT00143507|Eligible participants were men and women, with documented history of coronary artery disease, associated with left ventricular systolic dysfunction. Angina and/or heart failure symptoms should have been stable for ≥ 3 months, with optimal conventional cardiovascular medication on appropriate stable doses for at least 1 month.|Following a run-in period of two weeks during which no study treatment was dispensed, the participants were randomised to receive ivabradine or placebo in addition to their usual cardiovascular treatment in double-blind treatment period.
758312|NCT00143455|Enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory. The amendment reduced Irinotecan dose from 80 to 65 mg/m2. With the study powered for Overall Survival in subjects recruited thereafter (Cohort 2) efficacy analysis is reported.|
758313|NCT00143403|study was conducted at 66 centers.|Eligible subjects (subjects who underwent complete liver metastasis resection within 8 weeks of study drug administration) were randomly assigned. Of the 321 subjects randomized in the study, all but 15 were treated.
758314|NCT00143390||
758315|NCT00143312||Subjects with proven or probable Invasive Fungal Infection (IFI) in the previous 12 months, who were receiving an allogeneic Stem Cell Transplant (SCT) for any hematologic disease, were enrolled into the study if all other inclusion/exclusion criteria were met.
758316|NCT00143247|Subjects with type 1 or 2 diabetes in 1 of parent Phase 2 protocols (217-102,103,or 104)& received EXUBERA® (EXU)were enrolled. 173 subjects were screened,assigned to treatment,and treated for at least 1 day.For each subject,data from controlled and extension studies were combined to represent each subject's entire EXU exposure experience.|The objective of the study was to observe,in subjects with long-term exposure to EXUBERA®,pulmonary function over time.For each subject,data from the controlled study (217-102,103,and 104) were combined with data from the respective extension studies as well as the A2171036 extension study to represent each subject's entire EXU exposure experience.
758317|NCT00142935|All recruitment occurred at the Rhode Island Department of Corrections. Screening began on 9/15/2006 and the first participant was enrolled on 9/29/2006. The last participant was enrolled on 2/20/2009.|There were no significant events following participant enrollment and prior to group assignment.
758318|NCT00142909||
758319|NCT00142818||
758320|NCT00142792||
758321|NCT00142597||
758322|NCT00142519||
758323|NCT00142506||
758324|NCT00142454||
758325|NCT00142415||
758329|NCT00141921|"This study was designed to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe plaque psoriasis who participated in Study 20030211 (NCT00078819).
~The study was conducted at 38 sites in the United States and Canada."|Results reported below are from the main analysis performed at year 5 (264 weeks).
758330|NCT00141817||
758331|NCT00141778|Patients were recruited between 2005 and 2010 from Vanderbilt University Medical Center and Brigham and Women's Hospital|One week to four days prior to surgery, patients were randomized to treatment with placebo, ramipril or spironolactone. Preexisting ACE inhibitor, angiotensin receptor blocker, or MR antagonist use was stopped at randomization. Four hundred and fifty-eight patients met inclusion and were randomized
758332|NCT00141765||
758333|NCT00141739|The study was conducted with recruitment taking place at the Blood and Marrow Transplantation Programs of the University of Michigan in Ann Arbor, Michigan and at Loyola University Medical Center, in Maywood, Illinois. The patients participating in this study, underwent transplantation, dating from April 2005-November 2009.|Patients >1 year of age who were candidates for a myeloablative allo-hemopoietic cell transplant were eligible for inclusion. Donors and recipients were required to match for 7/8 or 8/8 HLA-A, HLA-B, HLA-C, and HLA-DRB1 loci. Patients with an 8/8 HLA-matched related donor were not eligible.
758334|NCT00141726|Study subjects were recruited from the Blood and Marrow Stem Cell Program at the University of Michigan Medical Center between 2001 and 2008, all subjects having received an allogeneic Stem Cell Transplant (SCT) at least 100 days before study entry.|
758335|NCT00141518||
758336|NCT00141453|The study population was defined by the inclusion criteria. This study was carried out at 74 centers in Japan and 3 centers in Hong Kong. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. First Patient in: 19 May 2003.|During 6-week screening, patients were treated with placebo and assessed for eligibility. Eligible patients were assigned to 10mg of olmesartan or placebo. 857 were screened; 577 were randomized; 566=the full analysis set (11 who completed were excluded for protocol violations). Data are based on the participants in the full analysis set.
758337|NCT00141297||
758338|NCT00141271|56 centers in the US|7-day washout:psychotropic drugs & lithium. 4-week washout: monoamine oxidase inhibitors, fluoxetine alone or in combination with olanzapine. Depot neuroleptic Discontinued (DC'd) 6 mo prior to entry. 536 subjects enrolled: 504 assigned to drug; 32 not assigned:18 lost to follow up, 5 DC'd study, 9 didn't take/receive study drug for other reasons.
758339|NCT00141219|Study Initiation and Completion Dates: 27 December 2005 to 28 December 2007; 10 study centers in Korea|241 subjects were assigned to study treatment; one subject was randomized but did not receive any study treatment with the reason 'Did not meet entrance criteria'.
758340|NCT00141115|Three participants were enrolled into this clinical trial at the New York State Psychiatric Insitute/Columbia University Medical Center.|Participants were enrolled under open-label conditions.
758341|NCT00141102||
758342|NCT00141037|Twelve pediatric kidney transplantation centers in the United States enrolled 130 subjects (less than 21 years of age) who received a primary kidney transplant from a deceased or living donor. Subject enrollment occurred between March 2004 and July 2006.|
758343|NCT00140842|17 obese and 30 normal-weight adolescents (12-18 yr old) were screened for study eligibility.15 obese adolescents completed the study visit. These subjects were matched for race, ethnicity, and bone age to normal-weight adolescents from the pool of screened subjects.|
758344|NCT00140621|The study was conducted at 7 centers between July 06, 2005 and August 6, 2012. One participant was treated at 2 study sites because the participant had to be transferred to another site during the study.|
758345|NCT00140556|Participants were recruited from the multidisciplinary ENT or Radiation Oncology Clinics between September 2005 and February 2009.|
758346|NCT00140426||
758347|NCT00140413|Participants were recruited from an IRB-approved prospective optic nerve hypoplasia (ONH) registry study at Children's Hospital Los Angeles, between January 2005 through March 2011.|39 participants were screened for eligibility: 20 enrolled in the study; 6 failed to meet inclusion criteria; 9 declined participation; and 4 consented to participate but withdrew from the study prior to beginning any study procedures.
758348|NCT00140244||
758349|NCT00140231||
758350|NCT00140205||
758351|NCT00140140||
758352|NCT00139997||
758353|NCT00139776|111 centers in the Americas and Europe enrolled and treated subjects (2 centers in Belgium, 4 centers in Brazil, 20 centers in Canada, 5 centers in Chile, 5 centers in Columbia, 1 center in France, 15 centers in the United Kingdom, and 59 centers in the United States).|17 participants completed Open-label run-in Period II and were randomized to Period III Double Blind but not treated.
758354|NCT00139737|This extension study enrolled eligible subjects with schizophrenia who had successfully completed a previous Phase 3 ziprasidone study (A1281028, A1281044 or A1281045 [NCT00136994]), allowing enrolled subjects to continue treatment with ziprasidone for at least 1 year or until the drug became commercially available.|
758355|NCT00139659|Subjects were recruited at 63 centers and participated in the study between 10 January 2003 and 22 October 2008.|544 subjects were screened for the study. Prior to randomization subjects completed a 3-week run-in period during which all subjects received subcutaneous insulin. Of 288 subjects randomized, only 286 received randomized treatment; one subject assigned to inhaled insulin received subcutaneous insulin, and 1 subject DC'd prior to treatment.
758356|NCT00139477|Participants recruited from pediatric endocrinology clinics, in Jacksonville, USA between November 2003 and April 2008.|375 participants recruited; 177 obese participants screened, 111 excluded (62 did not meet inclusion criteria and 4 refused participation).
758357|NCT00139399||
758358|NCT00138671||
758359|NCT00138658|Participants were recruited at 15 institutions with a primary focus on oncology and located in the United States and Canada. The date of the first screening visit was November 2004 and the last survival followup was February 2010.|Four subjects who were assigned a study ID number were determined to be ineligible (i.e., failed one or more inclusion/exclusion criteria) and were never treated.
758360|NCT00138645||
758361|NCT00138424||
758432|NCT00131573||Although enrollment numbers totaled 118 subjects, the total number of implanted subjects were used for the analysis. Total number of implanted subjects is 85.
758362|NCT00138294|The participants in the intervention cities were enrolled to the study and signed informed consent. The participants in the comparison cities were not enrolled to the study and the relevant data for these participants were obtained from the Scott and White Clinic database.|
758363|NCT00138203|Recruitment will occur at all participating sites from August 2005 - June 2007.|
758364|NCT00138151|Subjects were recruited from 4 sites across New Jersey (2 academic medical centers and 2 community hospitals) from March 2001 through June 2009.|
758365|NCT00138125|recruitment period from June 2005 - August 2008 at academic medical clinics and community medical clinics.|
758366|NCT00138073||
758367|NCT00138034|Patients were included from 1 january 2005 until december 2009|
758368|NCT00137969||
758369|NCT00137839|Participants were enrolled November 2004 to November 2008.|
758370|NCT00137631|From August 2005 through November 2006, People of Color in Crisis Inc. recruited potential participants from venues throughout New York City.|
758371|NCT00137449||Must have failed prior treatment with imatinib mesylate (IM) [defined as progression of disease using Response Evaluation Criteria in Solid Tumors(RECIST) or World Health Organization(WHO) criteria, or significant toxicity during treatment with IM precluding further treatment & Eastern Cooperative Oncology Group(ECOG) performance status of 0-1]
758372|NCT00137436||Once the Optimal Combination Dose of SU011248, Docetaxel, and prednisone was determined in Phase 1, the study proceeded to Phase 2. There were 38 participants in Phase 1; those participants did not continue into Phase 2. Per FDAAA, only Phase 2 data are posted; timeframes are relative to Phase 2.
758373|NCT00137423|Patients must have failed 1 prior cytokine-based therapy for metastatic renal cell carcinoma and had to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.|ECOG performance status definition 0=fully active, able to carry on all pre-disease activities without restriction 1= restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature (eg light house work or office work)
758374|NCT00137280|Patients were selected randomly from the population of individuals with schizophrenia receiving care at VA mental health clinics. All clinicians and managers at mental health clinics were selected.|Patients were excluded if they did not meet inclusion criteria, refused to participate, or were not approached about participation. Staff were excluded if they refused to participate.
758375|NCT00137267||
758376|NCT00137111|501 patients were recruited between June 2000 and October 2007.|501 patients were enrolled on the study. 3 patients were determined to be ineligible shortly after enrollment (wrong diagnosis - AML or CML in blast crisis).498 patients started the study.
758377|NCT00137046|A total of 64 centers took part in the study between 09 May 2002 and 08 December 2008.|At the screening visit and during the 4-week run-in phase all subjects received a subcutaneous insulin regimen consisting of 2 to 3 doses per day of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 doses daily of intermediate-/long-acting insulin (NPH insulin or Ultralente), or insulin glargine once daily at bedtime.
758378|NCT00136955||All 41 subjects had a primary diagnosis of squamous cell carcinoma of the cervix with a mean duration of 2.8 years (range: 0-12.9 years) since first diagnosis. No subject had a history of other cancer.
758379|NCT00136916||At screening visit and during the 4-week run-in phase subjects received subcutaneous insulin regime of 2 to 3 daily doses (QD) of regular insulin-/short-acting insulin analog (lispro or aspart) and 1 or 2 doses QD of intermediate or long-acting insulin (neutral protamine hagedorn [NPH] insulin or Ultralente®) or insulin glargine QD at bedtime.
758380|NCT00136838|Twelve participants were recruited through advertisements in local newspapers and flyers.|
758381|NCT00136812|Adult smokers (N=224) were recruited between July 2006 and December 2008 from the adult inpatient psychiatry unit at the Langley Porter Psychiatric Institute (LPPI) located on the University of California, San Francisco (UCSF) medical school campus.|
758382|NCT00136760|Participants were recruited from the community, using advertisements, and were recruited from an outpatient clinic at a local VA medical Center.|Participants underwent telephone and in-person screening for eligibility criteria.
758383|NCT00136695||
758384|NCT00136604||
758385|NCT00136357||
758386|NCT00136318|A total of 208 of the 300 patients screened were enrolled between August 2004 and September 2008 in different centers in the pre-observation period. Overall 181 patients started the treatment period by taking escitalopram or placebo.|A total of 208 of the 300 patients screened were enrolled between August 2004 and September 2008. 92 patients did not meet the inclusion criteria, had exclusion criteria or did not want to participate in the trial.27 patients stopped the trial during the preobservation period before the trial started by taking antidepressant or placebo therapy.
758387|NCT00136214||
758388|NCT00136084|238 patients were recruited between October, 2002 and June, 2008.|238 patients were enrolled on the study. This report is based on results for 223 patients. 15 patients were excluded for the following reasons: 7 were switched to lymphoid-directed therapy shortly after enrollment, 6 were determined to be ineligible shortly after enrollment (wrong diagnosis), and 2 were not randomized.
758389|NCT00135798|Persons were enrolled from October 2005 to January 2009, and followed through December 2009. Patients were enrolled at 7 clinical transplant centers in the United States.|No pre-assignment events. Randomization occurred immediately after enrollment.
758390|NCT00135707|The trial was conducted from July 2003 through February 2008 at the 16 clinical centers and the independent data coordinating center of the MFMU Network. Gestational age at randomization was between 9 weeks 0 days and 16 weeks 6 days. Women were eligible for inclusion if they had not had a previous pregnancy that lasted beyond 19 weeks 6 days.|Women who were no more than 15 weeks pregnant and who consented to participate in the study were given a supply of placebo and asked to return within 2 weeks. Those who returned, who had taken at least 50% of the placebo they were supposed to have taken, and who still met the eligibility criteria were randomly assigned to receive study drug.
758391|NCT00135694|Participants with liver failure due to hepatitis C infection or non-immune, non-viral causes were enrolled between October 2005 and April 2011.|Participants 12-24 months post-transplant, stable on immunosuppression monotherapy for at least 3 months prior to random assignment, with stage 2 or less fibrosis on the Ishak scale, adequate hepatic and renal function, and no biopsy-proven rejection were randomized between November 2006 and December 2012.
758392|NCT00135512|From 01 December 2004 to 28 May 2007, total of 234 participants with major depressive disorder were randomized at 36 centers in Japan.|During the screening (1 week), participants received Dose Level 1; bupropion sustained release (SR) 100 milligrams (mg) placebo tablet once daily in the morning.
758393|NCT00135356||A total of 219 participants were enrolled and 18 were never randomized (1 poor/noncompliance; 10 no longer met study criteria; 5 withdrew consent). 201 participants were randomized; however, 1 participant was never treated and is not included in the participant flow.
758394|NCT00135330|Enrollment occurred between 18 October 2005 and 14 March 2008.|
758395|NCT00135226|Participants were randomized between June 2005 through July 2011. Follow-up continued until March 2018.|
758396|NCT00135200||
758397|NCT00134901|Individuals who applied for treatment at Columbia University's Substance Treatment and Research Service (STARS) outpatient clinic in New York City, USA, were recruited for this study. The study recruited from March 2003-February 2007.|patients entered a 2-week, single-blind placebo lead-in period. To be eligible for randomization, patients were required to attend at least 2 of 4 scheduled therapy sessions and to submit at least 4 of 6 scheduled urine samples during the two weeks of the lead-in period.
758398|NCT00134784||
758399|NCT00134719|Subjects were randomised at the beginning of the primary vaccination phase and kept their group assignment during the fourth dose vaccination phase. Not all subjects who completed the primary vaccination phase returned for participation in the fourth dose vaccination phase.|One subject who had a subject number allocated, was not vaccinated.
758400|NCT00134563|"The recruitment initiated in September 2004 was completed in February 2008.
~A total of 1338 patients were screened at 127 sites in 21 countries."|"Randomization was stratified by country and baseline disability (Expanded Disability Status Scale [EDSS] score ≤3.5 or >3.5).
~Assignment to groups was done centrally using an Interactive Voice Response System (IVRS] in a 1:1:1 ratio after confirmation of the selection criteria.
~1088 participants were randomized."
758401|NCT00134381||
758402|NCT00134082||One participant was a screen failure.
758403|NCT00134056||
758404|NCT00134043||
758405|NCT00134017||
758406|NCT00134004||
758407|NCT00133991||2 participants were found to be HIV+ after initiating the study and are considered to be screen failures as defined by the protocol.
758408|NCT00133978|This trial was conducted between April 2005 and December 2011 in 40 ICUs in participating countries after local jurisdictional and institutional Research Ethics Board approval.|Written informed consent was obtained from patients or their legal representatives before enrollment.
758409|NCT00133952||
758410|NCT00133809||Ten participants fulfilled entry criteria and were listed for islet transplantation. Prior to receiving the transplant, one of the participants became ineligible while on the organ donor waiting list due to glucose control being stabilized with an insulin pump, and an additional participant was lost to follow up.
758411|NCT00133705|Women were recruited between March 3, 2004 and March 30, 2005 through local media and contacts with community physicians.|38 women were deemed ineligible. Of those exclusion criteria applied to 27 and 11 declined participation.
758412|NCT00133575|Normal healthy vaccinia-naïve young adults who reside in the greater Boston metropolitan area were recruited for this study between September 29, 2005 and April 23, 2007.|
758413|NCT00132964||
758414|NCT00132873||
758415|NCT00132808||Eligible patients were stratified according to their duration of menopause (those less than 5 years from menopause were included in Stratum I, while those 5 or more years from menopause were included in Stratum II), and randomized equally to one of the three treatment groups.
758416|NCT00132769||
758417|NCT00132730||
758418|NCT00132691|Eligible patients were enrolled at 23 uveitis centers in the US, the United Kingdom and Australia from 6 December 2005 to 9 December 2008.|579 patients were assessed for initial eligibility (e.g. through chart review). Patients who were potentially eligible and interested in joining the trial signed an informed consent and underwent a baseline visit to confirm eligibility. Eligible patients (255) were randomly assigned to systemic treatment or implant treatment.
758419|NCT00132678|A total of 559 (440 + 119) subjects received at least one dose of study drug. A total of 440 subjects (acute episode or stable on other antipsychotic) entered period II, 382 subjects completed and entered period III. An additional 119 subjects (stable on risperidone) entered period III directly. Overall 501 (382 + 119) subjects entered period III.|Subjects with an acute episode or who were stable on another antipsychotic entered Period II; Period II responders entered Period III. Subjects stable on RIS at screening entered Period III directly. Subjects who maintained response and had a stable dose of RIS LAI for the last 8 weeks of Period III were randomized to RIS LAI or placebo(Period IV).
758420|NCT00132496|This study was recruited at 25 centers in the US during the period of 18-Aug-2005 and 1-May-2006.|There was a screening period of up to 2 days before treatment assignment
758421|NCT00132314|September 2006 - December 2008; 19 VA medical centers|
758422|NCT00132301||
758423|NCT00132132||
758424|NCT00132041||
758425|NCT00132028||
758426|NCT00132002||
758427|NCT00131937||
758428|NCT00131911|Between June 21, 2005 and September 15, 2006, a total of 93 (51 carcinoid, 42 islet cell) patients initiated treatment on this study.|One carcinoid patient canceled prior to treatment and was excluded from all analyses.
758429|NCT00131885|Eligible participants were recruited via local advertising.|No enrolled participants were excluded
758430|NCT00131677|"Recruitment began in 1/2005 and was completed in 7/2007. Participant follow-up was completed in July 2009.
~Participants were recruited from:
~San Francisco Dept. of Public Health AIDS Research Consortium of Atlanta Fenway Health"|After an initial screening visit, participants were required to meet all enrollment criteria again at the enrollment visit.
758431|NCT00131664|391 patients were randomized from 49 Canadian sites of General Practitioners and Community Endocrinologists during an 8 month recruitment period.|This open-label, prospective, randomized multi-centre study included naïve or recently treated type 2 diabetes mellitus (T2DM) patients. Recently treated patients (up to 3 years on single therapy of a low to moderate dose of Glyburide or Amaryl™ or Metformin) entered the study after a 2-week wash-out period.
758435|NCT00131456|The study was conducted from January 2004 through September 2010. Treatment seekers for problems related to marijuana use were recruited by local advertising or clinical referrals. Participants were treated at Columbia University/New York State Psychiatric Institute or at Columbia University/North Shore-LIJ Medical Center.|The trial included a one-week placebo lead-in. Placebo responders during the placebo lead in (N = 7), defined as a Clinical Global Impression rating of 1 or 2 and a reduction in the Hamilton Depression score > 75% or total score ≤ 7, were not randomized. Additionally, 13 participants were lost to follow-up so a total of 103 were randomized.
758436|NCT00131378||
758437|NCT00131365|The protocol was approved to enroll 20 participants; however, due to the obsolescence of device features the study was closed after enrolling 9 participants.|
758438|NCT00131352||329 participants enrolled and 76 screening failures. One participant was randomised to the Synvisc group but received Saline in error; counted in the Saline group for safety analyses (Safety population) and in the Synvisc group for efficacy analyses (Intent-to-treat population) in both study periods.
758439|NCT00131248|participants = premature infants, <36 weeks gestation at birth, recruited from NICU at a hospital in Houston, Texas,USA, between 2004-2009|
758440|NCT00130923||
758441|NCT00130832|Enrollment occurred at 9 study sites in Mexico, Costa Rica, Guatemala, and Brazil from 19-Oct-2005 (first subject in) to 06-Jan-2006 (last subject randomized).|Excluded from randomization were subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive, clinical evidence of active gastrointestinal illness and those with fever, a rectal temperature ≥38.1°C (≥100.5°F) at time of immunization.
758442|NCT00130793|"Patients were recruited at 14 sites in the United States.
~First patient randomized: 08Aug2005; Last patient last visit: 28Nov2005"|
758443|NCT00130780||
758444|NCT00130728||
758445|NCT00130689|Patients enrolled from September 2005 through November 2008.|
758446|NCT00130637|single center, 6 participants|pilot, non-randomized, open-label trial
758447|NCT00130533|Between October 2006 and September 2011, 876 patients were recruited, across 80 institutions in 8 countries (Spain, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, and Venezuela)|
758448|NCT00130520|The study began recruiting in June of 2005 and ended recruitment in January of 2008. All subjects were seen and treated at the Arizona Cancer Center in Tucson, Arizona.|The study had no pre-assignment criteria. This was an open label study and all subjects were given the same treatment.
758449|NCT00130286||
758450|NCT00130247|HIV-uninfected 18 to 60 year old adults with suspected or newly diagnosed pulmonary tuberculosis were eligible for enrollment at participating sites in Kampala, Uganda; Vitória, Brazil; and Manila/Makati City, the Philippines. Screening began in April 2002 in Uganda, December 2002 in Brazil, and November 2003 in the Philippines.|Subjects who met eligibility criteria were started on standard chemotherapy and routinely followed during anti-TB therapy. Patients with drug-susceptible TB who were sputum culture negative after 2 months of treatment were randomly assigned at 4 months to stop treatment or received an additional 2 months of daily isoniazid (INH) and rifampicin.
758451|NCT00130208||
758452|NCT00130117||
758453|NCT00130039|"507 patients were registered www.toss2.com from 20 centers of 4 countries (Korea, Hongkong, Thailand, Philippines). 50 patients were excluded during case verification process because they did not satisfy patient's eligibility criteria.
~finally 457 patients were randomized into cilostazol or clopidogrel group"|The excluded patients did not satisfy the definition of the symptomatic stenosis of our study protocol.
758454|NCT00129987||
758455|NCT00129974||
758456|NCT00129961|Subjects were recruited in Australia, New Zealand and North America from August 2005 (first subject randomized September 2005) through October 2007.|Screening and baseline evaluations were performed within 4 weeks prior to randomization. Randomization assignments by site were stratified by the number of new NMSC lesions in the 12 months prior to enrollment (0-5 lesions vs 6-20 lesions).
758457|NCT00129935|1,384 patients were recruited in 58 Spanish centers and randomized to receive EC-T (n=669) or ET-X (n=715). 5 patients received no treatment in the ET-X arm. 4 patients were not treated with the study medication to which they were randomized (n=3 EC-T arm; n=1 ET-X arm). 1,378 patients were evaluable for safety (n=667 and 711 respectively).|
758458|NCT00129766|A total of 6,635 children were randomized in a 1:1 ratio at 347 centers in 24 countries within the Northern and Southern hemispheres between 01/Nov/2004 and 09/Dec/2005; each child participated in the study for a single RSV season.|Randomization was blocked by study site and stratified according to presence/absence of CLD of prematurity requiring medical intervention/management.
758459|NCT00129740||
758460|NCT00129727|Recruitment occurred during the planned time frame. Recruitment occurred at Massachusetts General Hospital; Dana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; and Women and Infants Hospital of Rhode Island.|
758461|NCT00129701||
758462|NCT00129649||
758463|NCT00129623|This study was conducted at 10 centers in the United States.|Of the 451 participants who were screened, 160 participants were randomly assigned to the two treatment arms (Placebo and Ibandronate). The major reason for screening failure was participants did not meet the Bone Mineral Density (BMD) entry criteria.
758464|NCT00129545||
758465|NCT00129480||
758466|NCT00129467|Subjects were enrolled from February 2005 through August 2009. Potential subjects were recruited from: a VA Nursing Skilled Care Unit, VA outpatient oncology and palliative care clinics, a community hospice and oncology and radiation clinics at a university hospital affiliated with a VA medical center.|Subjects completed screening scales on depression, cognition, and psychiatric symptoms and their medical records were reviewed to confirm eligibility. 47 subjects were enrolled, 12 did not meet criteria, 1 person declined screening after consenting, 2 subjects were randomized but did not receive the intervention (1 withdrew and 1 became ineligible)
758493|NCT00127803|Participants were enrolled from 13 July 2005 to 27 July 2005 in 2 medical centers in the US.|A total of 50 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
758963|NCT00096122|Recruitment Period: 9/16/2004 to 9/22/2006. All patients registered at The University of Texas M.D. Anderson Cancer Center.|One participant enrolled was excluded from the study.
758964|NCT00096109|Cancer center clinic.|
758965|NCT00096044||
758467|NCT00129441|Participants were recruited through referrals from clinicians in the outpatient clinical services at Western Psychiatric Institute & Clinic and through a Psychosis Registry. 29 males signed consent and 16 were eligible-one subject did not complete the study and is not included in any summary statistics. Recruitment period: 4/05 through 1/07.|To ensure eligibility before randomization, the following were administered: a urine drug screen; diagnostic, medical history and adverse events ratings; Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); electrocardiogram; blood tests (for kidney and liver function); and a complete eye exam, including a slit-lamp exam.
758468|NCT00129402||
758469|NCT00129389|1925 patients from 67 Spanish sites were assigned to receive FAC-wP (n=951) or FAC (n=974). 8 patients received no treatment (5 FAC-wP, 3 FAC), and 17 were not treated with the study medication to which they were randomly assigned (1 FAC, 16 FAC-wP). A total of 1,917 patients were evaluable for safety (931 FAC-wP, 986 FAC).|
758470|NCT00129376||
758471|NCT00129311||
758472|NCT00129285||
758473|NCT00129272|Participants between ages 12 and 25 years who smoked at least 10 cigarettes per day over a period of 6 months were recruited between 2004 and 2010 through advertisements in local newspapers and flyers in local community agencies and primary care clinics.|Participants completed an assessment for nicotine dependence and psychiatric disorders, and a laboratory stress study to assess baseline salivary cortisol over 2 hours and cortisol responses to a psychosocial stressor (public speaking and arithmetic tasks). Those who continued to meet study criteria were then randomized to active drug or placebo.
758474|NCT00129259|Seven centers randomized 83 subjects between September 2005 and March 2009. Seventy-seven subjects are in the intent-to-treat (ITT) population. Those not in the ITT population did not have a baseline visit and were not included in the participant flow portion of the results section.|At a screening visit, subjects underwent procedures to establish that all inclusion criteria were met and none of the exclusion criteria were met. All subjects or guardians provided written informed consent at screening.
758475|NCT00129246||
758476|NCT00129220||Study Period I was a week-long Screening Period. Study Period II was a 3-week-long Early Double-Blind Period. Study Period III was a 3-week-long Last Double-Blind Period.
758477|NCT00129129|In a Primary Phase (study 101858), 3 groups, MenHibrix, ActiHIB and Menomune, were followed from Day 0 to either Month (M) 7 or 10, depending on vaccination. Then, in a Fourth-Dose Phase (study 102015), 3 groups (MenHibrix, ActiHIB/ActHIB and ActiHIB/MenHibrix) were followed from M10-13 to study end (M16-19). Treatment allocation: primary phase:|MenHibrix Group was followed during the entire study period, from Day 0 to M16-19). ActiHIB Group was followed as ActiHIB Group up to M10-13, when it was split into the ActHIB/ActHIB and ActHIB/MenHibrix groups, these latter being followed from M10-13 to study end. Menomune Group was followed up to M7.
758478|NCT00129116||"The study is divided in two phases:
~Primary phase: 3-dose primary vaccination at 2, 3 and 4 months of age = study Months 0, 1, 2. Data were collected up to 1 month after the 3rd dose (study Month 3)
~Booster phase: booster dose at 12-18 months of age = study Month 0. Data were collected up to 1 month after the booster dose (study Month 1)"
758479|NCT00128921|Recruitment was between 4/17/2006 to 11/26/2007. The Recruitment occurred in the Myeloma outpatient clinic.|Enrollment plan was as follows: The first 10 were enrolled in Arm A, the next 10 were enrolled in Arm B and the last 10 were to be enrolled in Arm C. 10 participants were enrolled on Arm A, 8 participants on Arm B and 0 on Arm C. Of the 8 participants in Arm B, only 6 were analyzed because 2 withdrew before receiving bortezomib.
758480|NCT00128830|In this study, 211 participants were enrolled in 12 different countries. The majority of participants (49%) were enrolled in the United States.|In total, 211 participants (93 who rolled over from the etravirine arm of study TMC125-C203 (NCT00412646), 85 who rolled over from the etravirine arm of study TMC125-C223 (NCT00081978), 29 who rolled over from study TMC125-C211 (NCT00111280) and 4 who rolled over from study TMC125-C209) received treatment with etravirine.
758481|NCT00128713||
758482|NCT00128661||Solicited symptoms were collected for 3730 and 3740 subjects instead of the 3727 and 3739 subjects who were randomized in the study in the Cervarix and the Havrix groups, respectively. These 4 subjects received both vaccines and were included in the denominator of both arm based on the actual vaccine type administered.
758483|NCT00128492|Open-label, Phase 3 follow-on study for participants from Studies CP-AI-005 (NCT00104520) and CP-AI-007 (NCT00112359). Participants were enrolled at 71 sites in the United States, Canada, Australia, and New Zealand. The date of first enrollment was 17 August 2005, and the date of database lock was 23 January 2009.|Participants enrolled in this study were required to have previously participated in CP-AI-005 or CP-AI-007. Participants from CP-AI-005 received open-label AZLI (75 mg) in the same regimen (twice daily [BID] or three times daily [TID]) to which they were previously randomized. Participants from CP-AI-007 received open-label AZLI (75 mg) TID.
758484|NCT00128401||9 participants were enrolled, but not assigned to treatment.
758485|NCT00128219|Young (ages 18 through 40), sexually active (sex at least once in the last 4 months), non-pregnant women from the surrounding communities and who were negative for vaginal and rectal colonization with type III group B streptococcus (GBS) were offered enrollment, between July 7, 2003 and August 8, 2006|Participants were screened for vaginal and rectal colonization with type III GBS and only those negative were offered enrollment
758486|NCT00128206|Inmates in the San Francisco City and County Jail diagnosed with latent tuberculosis infection (LTBI) at jail entry were recruited,consented and enrolled between 11/30/2004 and 9/24/2007.|Of 416 inmates with LTBI who consented to be enrolled, 52 were not randomized because of abnormal liver function tests (20), they were released before they could be assigned to a group (30), or they subsequently changed their mind and refused participation (2).
758487|NCT00128193|Stage A (10) and B (90) participants were recruited from Lalitpur Nursing Campus in Kathmandu, Nepal. All participants for stages C1 (80) and C1b (80) were recruited from either Anandaban Hospital in Kathmandu, Nepal or Patan Hospital in Lalitpur, Nepal. Enrollment occurred between 30Apr2002 and 12Aug2009.|
758488|NCT00128180||
758489|NCT00128102||
758490|NCT00127933||
758491|NCT00127855||Of the 409 subjects enrolled, two subjects were determined to be ineligible for enrolment and were actually never vaccinated. Not all subjects that started the primary vaccination course returned for the polysaccharide challenge dose administration.
758492|NCT00127842|Participants were enrolled from 5 August 2005 through 2 February 2007|
758494|NCT00127790|Men and women aged 35-75 experiencing chronic pain and insomnia were recruited from the community through newspaper advertisements and from local pain clinics via recruitment flyers.|Participants completed intake interview, physical exam, clinical chemistries and toxicology screens; completed daily pain-sleep diaries for two weeks; and then underwent polysomnography. Seven subjects were excluded prior to randomization (4 due to sleep apnea, 1 did not meet pain severity criteria, and 2 subsequently declined to participate).
758495|NCT00127712||
758496|NCT00127660||
758497|NCT00127608|"Similar numbers of subjects presenting with different varicella rash intensities were enrolled:
~Severe: more than 150 lesions on multiple parts of the body; rash is mostly vesicular
~Moderate: 51 to 150 lesions; rash is vesicular and/or maculopapular
~Mild: 1-50 lesions; rash is maculopapular rather than vesicular"|"Out of 503 samples collected, 6 were not received from the investigator and 12 were insufficient samples. Hence only 485 samples were tested by Q-PCR.
~All 13 samples from 1 subject were VZV DNA negative, suggesting the subject did not have varicella. Therefore, this subject was not included in the final analyses and hence not completed."
758498|NCT00127530||
758499|NCT00127439|Recruitment occurred through James A. Haley Veterans' Hospital, Tampa, VA; North Florida/South Georgia Veterans Health System, Gainesville, FL; Paralyzed Veterans of America - Central Florida Chapter; Brooks Rehabilitation Hospital, Jacksonville, FL; Shands Rehab Hospital, Gainesville, FL; and the FL Brain and SCI Network.|No significant events relative to enrollment.
758500|NCT00127413||If it was determined during the assessment that a participant did not meet criteria for PTSD or would be excluded based on pre-determined exclusion criteria (e.g., substance use, no pain, psychosis) then the assessment was terminated and additional study related data was not collected. This was done to reduce unnecessary participant burden.
758501|NCT00127231||
758502|NCT00127218|Participants were randomized in a 1:1 ratio to receive niacin or placebo, using a random number schema stratiﬁed to ensure equal numbers between age 65-74 years and 75 years and above. Study took place in a university outpatient center.|Participants were over age 65 years with a history of cardiovascular events or evidence of atherosclerosis at angiography (>50% stenosis) or non-invasive imaging, with baseline LDL<3.24 mmol/L if already on statin therapy and <3.89 mmol/L if untreated. There were no restrictions on HDL level.
758503|NCT00127205||
758504|NCT00127192|"Phase II.
~First patient in: 11 July 2005. Last patient, last visit: 8 March 2006.
~The study was conducted at 97 centers in Japan."|Patients 20-75 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and <10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.
758505|NCT00127166|Multicenter Study (30 Ex-US sites) Study Initiation Date: December 22, 2005 Study Completion Date: November 14, 2008|"For randomization, patients fulfilled the following criteria:
~Forced Expiratory Volume in one second (FEV1) ≥70% predicted while withholding beta (β)-agonist for at least 6 hours
~Exercise-induced bronchoconstriction (EIB) showing FEV1 ≥15% reduction from baseline while on inhaled corticosteroids demonstrated twice during the run-in period."
758506|NCT00127101||
758507|NCT00127062||Healthy volunteers were not recruited. Only asthma patients.
758508|NCT00127036||
758509|NCT00126776|recruited by VA mailing lists July 2004-June 2006|
758510|NCT00126750|Among 66 eligible medical centers, the investigators recruited 48 affiliated with 219 clinics, including 957 providers in 26 states, the VIrgin Islands, and Puerto Rico; of these, 168 clinics were randomized (ie, had >1 provider enroll)|Clinics were randomized when first eligible provider at that clinic logged on to the Web site.
758511|NCT00126737|The study sample was recruited from the general medicine and arthritis clinics of VA Hospital Hines, Illinois, and several non-VA affiliated community-based clinics.|143 subjects were screened for eligibility in the study. 33 subjects were excluded; reasons for exclusion: 7 = cardiovascular (CV) , 3 = hospitalized, 1= knee surgery, 6 = no transport, 5 = impaired cognition, 4 = spouse illness, 4= moved, and 3 = disagree with assignment/not interested. 110 subjects were then randomized.
758512|NCT00126659|Recruitment Period: January 11, 2006 to July 12, 2007. All recruitment done at UT MD Anderson Cancer Center.|This trial was run at the same time as a competing trial and suffered from poor accrual. For that reason it was closed.
758513|NCT00126594|Recruitment Period: June 23, 2005 to June 28, 2007. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
758514|NCT00126581|Between August 2005 and April 2009, 188 participants were enrolled.|Seven participants withdrew consent before initiating study therapy, therefore, 181 participants were randomized to either arm.
758515|NCT00126568|Subjects recruited from June 2005 to April 2011 from medical clinics|
758516|NCT00126555|Recruitment Period: April 08, 2005 to March 13, 2008. All participants were recruited at the University of Texas (UT) MD Anderson Cancer Center.|Of the 23 participants enrolled, one participant who was not evaluable for response withdrew before beginning treatment and is included the study demographics.
758517|NCT00126503|This Phase I/II study was open 5/2005 through 12/2010.|73 patients consented, 4 of whom were determined to be ineligible.
758518|NCT00126490|The recruitment period began 03/23/2005 and accrual was closed 8/21/2007 due to slow accrual.|24 enrolled but 5 were never treated (moved away, creatinine too high, Hospice before starting, lived too far away to come, chromophobe subtype after review of pathology)
758519|NCT00126438|A total of 753 participants were screened, of whom 197 were screen failures due to inclusion/exclusion criteria; 24 withdrawn at participant's request; 2 withdrawn at investigator's request and 15 failed to complete all screening procedures.|A total 515 participants (453 Heart failure [HF] and 62 control) were enrolled in the study and received a single dose of investigational medicinal product (IMP) at 43 investigational centers.
758520|NCT00126425|A total of 712 participants were screened, of whom 587 participants were enrolled.|Of 587 participants, 6 were withdrawn prior to receiving investigational medicinal product (IMP). A total of 581 participants (533 Heart Failure [HF] and 48 control), were dosed at the 54 centers. However, one of these participants was administered 123I-mIBG not manufactured by the sponsor, and therefore excluded from all analyses.
758584|NCT00121667||1462 participants were enrolled, and 787 entered the lead-in period. 45 discontinued the during the lead-in period. 19 subjects no longer met study criteria, 10 subjects withdrew consent, and 2 subjects were randomized but not treated.
758521|NCT00126191|This BL protocl was IRB approved 01/18/05, activated 7/18/05. Participants were identified either in the outpatient clinic at DFCI or while admitted to our partner inpatient hospital, Brigham & Women's Hospital. The study was closed to accrual 6/2/08 due to slow accrual.|Participants with previous chemotherapy or radiation, uncontrolled infection, concomitant malignancy (some exclusions), serious comorbid disease, pregnancy, and HIV+ were excluded. Subjects stratified according to risk: Single focus disease <10cm and normal LGH=low risk, all others high risk.
758522|NCT00126126|Three hundred twenty six Individuals with unilateral lower limb loss were screened. Twenty agreed to participate in the study and completed the consent process.|Twenty individuals who met inclusion criteria completed the consent process. Eighteen were randomized to either intervention (n = 9) or wait list control (n = 9).
758523|NCT00126113|Dissatisfied hearing aid users recruited from Portland VA Medical Center Audiology Clinic. Recruitment dates: 1/1/06 to 9/1/07|"Exclusion criteria were:
~Hearing aid dissatisfaction associated with physical fit of the hearing aids, conductive hearing loss, had not worn hearing aids for at least 3 months prior to participating, had mini mental status examination score below age and educationally-appropriate norms."
758524|NCT00125957||
758525|NCT00125931|Subjects were 18-60 year old male and female individuals who were currently hospitalized.|
758526|NCT00125853||
758527|NCT00125762||
758528|NCT00125658||
758529|NCT00125619||
758530|NCT00125593|SHARP was conducted in 380 centres in 18 countries: Austria, Australia, Canada, China, The Czech Republic, Denmark, Finland, France, Germany, Malaysia, The Netherlands, New Zealand, Norway, Poland, Sweden, Thailand, the United Kingdom and the United States of America. Recruitment occurred between 2003 and 2006.|Run-in period between screening and randomization of ~ 6 weeks duration. 11792 patients screened and 9438 randomized to the initial 3 arms. Overall 9270 patients were randomly assigned to simvastatin plus ezetimibe (4650 patients, 4193 initially plus 457 after first year) versus placebo (4620 patients, 4191 initially plus 429 after first year).
758531|NCT00125528||
758532|NCT00125515|Individuals who applied for treatment at the Columbia University's Substance Treatment and Research Service outpatient clinic in New York City were recruited for this study.|Following consent participants were admitted to an inpatient unti at NYSPI for the purpose od detoxification and naltrexone induction. On the second day of induction they were randomized to a study arm.
758533|NCT00125372||
758534|NCT00125359||
758535|NCT00125268||
758536|NCT00125242||
758537|NCT00125190|This was a open-label, multi-center and single-arm study conducted at 12 investigational sites (11 active) between 12 January 2005 and 14 January 2009. A total of 45 subjects were enrolled in this study.|The screening period consisted of two-staged clinic visits for up to 6 weeks, followed by an open-label treatment period of 86 weeks.
758538|NCT00125164|Study Initiation Date: 14 March 2004. Study completion Date: 02 July 2008. 44 investigators screened subjects; 14 did not enroll any subjects. 137 subjects were enrolled. Consent for one randomized subject was withdrawn prior to any study measurements. This subject was excluded from all analyses.|Subject screening consisted of three staged clinic visits over 6 weeks, including a medical history, complete physical examination, IGF-1 measurements, a Growth Hormone (GH) stimulation test, and an IGF-1 generation test.
758539|NCT00125138|Subjects were recruited from July 2005 to December 2007. Investigator sites were hospitals, research centers, movement disorder centers, and neurology centers.|Subjects entered the Screening/Washout Period (for all previous antipsychotic medications) for a maximum of 2 weeks. On Day 1, the criteria for Randomization were reviewed by the investigator and psychiatric, motor function, and safety assessments were performed. Subjects who qualified on Day 1 were randomized to receive melperone or placebo.
758540|NCT00125034|First & last subject randomized: 27 Jul 2005 & 8 Mar 2006, respectively. Primary outcome and disease control rate cut-off dates 4 Aug 2006, others: 1 Mar 2007; except overall survival, KRAS overall survival and KRAS progression-free survival outcomes, metastatic surgery outcome and adverse events: 30 Nov 2008.|629 subjects were prescreened, of whom 344 subjects were randomised. 338 subjects (Safety Population) received treatment. One subject was erroneously randomized, and was excluded from the ITT population (337 subjects).
758541|NCT00124982||Of 1286 participants enrolled in this study, 240 were not treated.
758542|NCT00124943||122 patients were randomized into the study and 112 received study medication.
758543|NCT00124917||All 6 participants enrolled in this trial received a dose of 7560 cGy and are grouped together in one Arm/Group. An attempt was made to escalate to the next higher dose but we were unable to treat patients and maintain safety standards.
758544|NCT00124748||
758545|NCT00124735||
758546|NCT00124709||
758547|NCT00124657|Overall accrual included 62 unique subjects. Five subjects participated in both Phase I and Phase II. Phase I enrolled 23 (03/2005-06/2007). Phase II enrolled an additional 39 participants (08/2007-11/2010) plus 5 carried over from Phase I for a total of 44. One of the 39 accrued to Phase II was enrolled at Rady Children's Hospital.|Participants had newly diagnosed high-grade glioma (except those originating in the brain stem) and unfavorable low-grade glioma and were ≥ 3 and ≤21 years of age. Participants receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study. Patients with spinal cord tumors were eligible for the Phase II component of this study.
758548|NCT00124618|This study enrolled a total of 58 patients. All patients received study treatment, and one patient was deemed ineligible during an North Central Cancer Treatment Group (NCCTG) audit. This analysis includes all 58 patients, with the exception of Overall Survival (OS), Time to Progression (TTP), and response which remove the ineligible patient.|
758549|NCT00124579||
758550|NCT00124462|Subjects will be recruited from: 1) various different forms of public media including Boston Globe, Baystate Banner. 2) BMC patients referred from colleagues in the rheumatology and orthopedic sections. 3) individuals already recruited for other clinical trials with consent forms that included permission to call subjects for other studies)|
758551|NCT00124449||184 participants were screened, 127 were enrolled but not randomized (5 withdrew consent; 120 no longer met study criteria; 2 other reasons). 57 participants were randomized, 1 participant was randomized but not treated.
758552|NCT00124176||
758966|NCT00096031||
758967|NCT00096018|Study Activated: 3/21/2002. Study Closed: 11/19/2010|
758553|NCT00124072|First Patient In: 28-SEP-1998, Last Patient Last Visit: 22-May-2008 Eighty-eight (88) sites in 3 countries: England 72, Scotland 12 and Wales 4.|Patients entered a run-in period during which they received simvastatin 20 mg daily and placebo-vitamin tablets for 2 months. Eligible patients who completed run-in were then randomized in a 2x2 factorial blinded design between simvastatin 80 mg daily versus simvastatin 20 mg daily and folic acid 2 mg + vitamin B12 1 mg daily versus placebo.
758554|NCT00124020|Enrollment Period: 23 January 2005 to 02 May 2007|14 patients (9 telavancin and 5 vancomycin) enrolled in the study but never started study treatment
758555|NCT00123955||
758556|NCT00123734|94 participants were enrolled into the study. The first participant was enrolled on 4 March 2005, and the last participant was enrolled on 6 February 2006. All participants were enrolled in hosptial.|12 participants did not recieve study drug (6 had no venography, 3 withdrew consent, 2 had an alternate diagnosis and 1 was a dropout).
758557|NCT00123682||
758558|NCT00123643|recruitment was performed at medical clinics|patients taking thiazolidinediones or sulfonylureas were allowed to washout of these medications 30 days prior to randomization
758559|NCT00123630||
758560|NCT00123604|Recruitment occured at medical clinics.|
758561|NCT00123487|Study started June 2005; recruitment completed March 2006; study ended June 2013 (Year 7) when the study closed and all participants were off study treatment. Those participants who were resistant or intolerant to prior imatinib were enrolled.|638 participants were enrolled; 27 were not randomized due to: adverse event (1), death (5), other (5), poor/noncompliance (1), no longer met criteria (13), withdrew consent (2). A total of 611 were randomized to treatment; 609 were treated: 2 randomized but not treated due to death (1) and serious adverse event (1).
758562|NCT00123474|Study initiated July 2005 and completed July 2014.|724 participants were enrolled, 670 were randomized, and 662 were treated with study drug. Reasons for non-randomization: 38 no longer met criteria, 8 other reasons, 7 withdrew consent, and 1 death.
758563|NCT00123422|192 patients were screened for eligibility in the study. 103 patients were randomly assigned to the one of the 3 groups. Patients were not randomized for the following reasons: PFT did not qualify (n=47), cardiac problems (n=13), changed mind (n=9), non-compliant (n=6), time constraints (n=5), too debilitated (n=3), other (n=6).|
758564|NCT00123409||
758565|NCT00123162||
758566|NCT00123123|Subjects were recruited from 1 March, 2004 until 30 November, 2007. Subjects were recruited from patients admitted to the ICU of the Erie County Medical Center (ECMC) who were mechanically ventilated. This ICU provides trauma, burn care, and rehabilitation and is an affiliated teaching facility for the State University of New York at Buffalo.|
758567|NCT00123110|The participants were recruited beginning 8/11/05 and continued until the last patient was consented on 4/8/08.|
758568|NCT00122980|Phase III First Patient In: 31-October-2006; Last Patient Last Visit: 15-December-2010; 25 medical clinics in the United States of America.|Participant qualification was initially evaluated by medical chart review and interview. Subsequent to subject consent, subjects were further screened to confirm eligibility. Screening included, in part, expert verification of initial stroke and of liver biopsy results prior to randomization.
758569|NCT00122954||
758570|NCT00122681||Of the 18729 subjects enrolled in the study, 64 subjects were not vaccinated. Within the 18665 subjects vaccinated, 21 subjects from 1 center were excluded from all analyses because of potential data discrepancies identified at this center. As a result, a total of 18644 subjects are reported as started in the participant flow.
758571|NCT00122460|First/last subject(informed consent): 14Dec 2004/28 Dec2005. Clinical cut-off: 12 Mar 2007. 80 centers in Europe: Austria (3), Belgium (5), Czech Republic (2), France (12),Germany (8), Hungary (4), Italy (5), Netherlands (4), Poland (5), Portugal (3), Russia (4), Slovakia (2), Spain (9), Sweden (3), Switzerland (3), UK (4), and Ukraine (4).|477 subjects screened. 41 ineligible for treatment at end of screening (inclusion/exclusion criteria not fulfilled (30),death (3),consent withdrawal(3), symptomatic deterioration(2),non-compliance with timelines(1),refusal to continue study procedures (1), missing (1).436 eligible for treatment; however 6 of the ineligible patients were randomized
758572|NCT00122447|"266 subjects with IGT were contacted: 121 refused, 63 ineligible, 84 screened/enrolled.
~Among the 84 enrolled subjects:
~1 was withdrawn, 13 dropped out before randomization, 70 were randomized (17 alpha lipoic acid, 18 aspirin, 18 olmesartan, 17 placebo).
~After randomization, 10 dropped out, and 3 were withdrawn."|
758573|NCT00122382||1052 participants were enrolled, 541 were not randomized (2 for adverse events, 32 subjects withdrew consent, 1 pregnancy, 6 lost to follow-up, 470 no longer met study criteria, 30 for other reasons).
758574|NCT00122369|Between February 2002 and March 2004, 240 eligible patients were recruited and randomly assigned to treatments. Four patients (including the only male) withdrew after entering the biopsy suite before starting with the intervention in the Intervention Groups or data collection in the Standard Care Group.|
758575|NCT00122317||
758576|NCT00122278||
758577|NCT00122187|We recruited 8 Veterans Affairs medical centers (VAMCs) to be involved with this trial evaluating a new method of processing positive colorectal cancer screening tests compared with usual care. 4 VAMCs (2 control and 2 intervention sites) dropped out of the study and 4 completed it.|Participating VAMCs were chosen that had electronic registries for gastroenterology (GI) endoscopic procedures available.
758578|NCT00122135||
758579|NCT00122109|Recruitment took place between 2005-2008. Participants were recruited across three VA Pacific Island Healthcare System clinical sites and Vet Centers across the Hawaiian Islands, Maui, and Oahu. Attempts were made to recruit 16 participants for each of 9 cohorts with 10 participants randomized into each conditon (VTC vs NP) within a cohort.|Of the 125 veterans who entered treatment, 112 attended at least 9 of 12 treatment sessions and were included in our completer sample (NP = 57 and VTC = 55).
758580|NCT00121992|"For the different subsets (Hormone-receptor Positive and HER2 PositiveStatus Subjects, Hormonal Receptor Positive and HER2 Negative Subjects, etc.), were assessed by central determination, and no all patients had tumor sample available."|
758581|NCT00121836||
758582|NCT00121810||
758583|NCT00121719|Participants took part in the study at 1 site in United Kingdom and 1 site in Netherlands from 01 July 2005 to 01 March 2019.|A total of 82 participants with solid tumors or lymphomas were enrolled and received study treatment.
758585|NCT00121641||1035 subjects were enrolled; 422 entered the 2-week dietary/exercise placebo lead-in. 21 did not enter double-blind treatment period (19 discontinued, 2 randomized but did not receive study drug). 68 with screening hemoglobin A1c (A1C) >10.0% and ≤12.0% entered directly in the open-label cohort; 66 received at least 1 dose of saxagliptin 10mg.
758586|NCT00121485||
758587|NCT00121472|486 patients were recruited at 36 cardiac transplantation hospitals between 8 Mar 2005 and 21 Apr 2008. After enrolling the initial 133 patients prespecified by the study protocol, an additional 353 patients were enrolled under a Continued Access Protocol(CAP) and in a concurrent Canadian study.|194 patients were followed to at least 1 year after implantation of the device, all 133 of the Pivotal Study Cohort patients and 61 of the US CAP patients, results of which are summarized below and in the final FDA-approved labeling for the HeartMate II LVAS. The remaining 292 patients followed for less than 1 year are not included.
758588|NCT00121238|16 patients were registered to the protocol at 6 centers between January 2005 and May 2007.|1 patient progressed clinically before any treatment and was not included in toxicity or efficacy endpoint analysis. Two patients who received drug were deemed ineligible because of PSA rise requirement and withdrawn for analysis for efficacy but their data was entered into toxicity analysis
758589|NCT00121225||
758590|NCT00121199||
758591|NCT00121186||
758592|NCT00121173||
758593|NCT00121134|This sequential cohort phase II study was performed in the outpatient setting at four institutions between 2005 and 2008.|A total of 164 participants were registered to enroll in the trial , but only 162 participants initiated treatment. So the evaluable population is 162 participants.
758594|NCT00120874||
758595|NCT00120627|Recruitment began in January 2006 and ended in December 2009. Participants were recruited from PTSD outpatient clinics and other primary care clinics in the VA system in southern California.|There were 4 subjects who dropped after random assignment and before entering the interventions. Two had scheduling conflicts and could not attend the groups at the time they were offered. One was too ill. The other did not have a reason.
758596|NCT00120523|First patient was enrolled into the study on 05 Apr 2004, last patient completed on 04 Oct 2010.|
758597|NCT00120406||
758598|NCT00120289||
758599|NCT00120250||
758600|NCT00120042||
758601|NCT00119847||
758602|NCT00119678||263 participants were enrolled in this study and 80 were excluded from the trial due to screening failure. Of the 183 randomized, 3 were not treated and 5 were treated but excluded due to site closure.
758603|NCT00119405|Recruitment occurred from 6/2005 to 11/2008. Participants were recruited from 3 HIV clinics in Cleveland, with the majority from the clinic at University Hospitals Case Medical Center.|Participants had to be HIV+ and naive to ARVs.
758604|NCT00119392||
758605|NCT00119379||
758606|NCT00119262|E2104 was opened on October 6,2005, and closed on November 6, 2006 with the final accrual of 226 patients.Study participants included Eastern Cooperative Oncology Group (ECOG) entire group, North Central Cancer Treatment Group (NCCTG) entire group and Cancer and Leukemia Group B (CALGB) entire group.|
758607|NCT00119158|Medical clinics at academic centers|Patients are self controls. Equivalent areas of eczema were compared
758608|NCT00119041||
758609|NCT00119015|Subjects were seen at the Nasal Physiology Laboratory at the University of Chicago.|"Those having residual symptoms (total nasal symptom score of 4+) after the open-label phase were randomized to montelukast or placebo for another two weeks in addition to fluticasone propionate. Of the 102 subjects in open-label phase, 54 with residual symptoms were randomized and are listed as completed in open-label period of participant flow."
758610|NCT00118911|Subjects were recruited via clinics associated with Massachusetts General Hospital, local radio advertisements, advertisements posted throughout the hospital, as well as through referrals from other mental health professionals. The study was conducted between November, 2004 and June, 2008 (follow-up was conducted through July, 2009).|A total of 138 individuals were consented and assessed for eligibility. Of these, 52 individuals were excluded prior to randomization (36 didn't meet inclusion criteria, 8 declined to participate, 6 were excluded for unknown reasons, and 2 were excluded for other reasons).
758611|NCT00118898|Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between September 21, 2005 (date first subject was randomized) and November 20, 2007 (date last subject was randomized).|1864 were randomized. Results reported for 1857 eligible participants; 7 were subsequently found ineligible and excluded from all analyses.
758612|NCT00118755||
758613|NCT00118742|Patients were recruited from 43 study centers in the US and Canada over a period of 3 years (24-Aug-05 to 03-Jul-08)|Eligible for the study were adult patients (18 to 74 years) who had received a single primary orthotopic liver transplant and were receiving or were scheduled to receive treatment with CellCept® + calcineurin inhibitor (CNI)
758614|NCT00118716|The study was conducted from 23 December 2003 to 23 April 2006 across 51 sites in the United States (US) and a total of 248 participants were randomized.|Out of 789 participants screened, 389 participants were screen failures and 152 participants were Baseline failures.
758615|NCT00118703|The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.|Males and females >=12 years of age, diagnosed with vasomotor rhinitis (VMR) and meeting the symptom requirements entered a 7 to 14 days screening period. Following screening period, participants meeting specified symptom criteria received treatment of either fluticasone furoate or placebo in 1:1 ratio up to 4 weeks.
758616|NCT00118534|Recruitment occurred between November 2004 and December 2007, with follow-up continuing until July 2009.943 patients were recruited from outpatient PTSD clinics at 10 VA medical centers and followed up for a minimum of 18 months.|Patients gave written informed consent before enrollment.
758617|NCT00118482|Patients were recruited between October 1998 and April 2003 from university hospitals in Canada, Columbia, the United States and Poland.|
758618|NCT00118430||
758968|NCT00095979|The study was activated on 5/2/2005 and closed to accrual on 1/3/2008 (suspended from 4/3/2006 to 4/1/2007).|
758619|NCT00118417|Participants were recruited by advertisement and referral to research at the Center for Anxiety and Traumatic Stress Related Disorders at Massachusetts General Hospital.|46 participants enrolled, but four participants were lost prior to Phase 1, two due to alcohol abuse and two due to follow-up. Participants were not randomized until the start of Phase 2.
758620|NCT00118404|Adult outpatients diagnosed with recurrent major depressive disorder (MDD) using the Structured Clinical Interview for Diagnostic and Statistical Manual-IV were recruited from January 2000-July 2008. The first diagnostic evaluation was completed in March 2000.|Eligible patients (n=523) entered 12-14 weeks of acute phase cognitive therapy. Responders (no MDD & Hamilton Rating Scale for Depression [HRSD] ≤12) were divided by lower & higher risk based on the final 7 HRSD scores. Only consenting, higher risk patients (N=241) were randomized into the 3 arms below. See Jarrett &Thase (2010) for design details.
758621|NCT00118378|Patients were enrolled from January 2005 until December 2008.|
758622|NCT00118365||
758623|NCT00118352||
758624|NCT00118287||
758625|NCT00118248|"From February 2005 thru April 2009, 41 participants were accrued to the this study.
~The study was closed to enrollment in July, 2009 due to a slow accrual rate."|From February 2005 thru February 2009, 17 participants were accrued to the Advanced Medullary Thyroid Carcinoma group. From February 2008 thru April 2009, 24 participants were accrued to the Differentiated Thyroid Carcinoma group.
758626|NCT00118209||
758627|NCT00118157||
758628|NCT00118144||
758629|NCT00118131|Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and 4 affiliate community hospitals part of the Cancer Institute of New Jersey Oncology Group from December 2003 through February 2008.|
758630|NCT00118092||
758631|NCT00118053|Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and 3 community hospitals within NJ from March 2005 through January 2007.|
758632|NCT00118040|Participants were recruited during a 3 year period by staff at 7 participating institutions (both University hospitals and community clinics).|
758633|NCT00117988|Recruitment Period: 02/08/2005 through 05/08/2009. All participant recruitment attempted at UT MD Anderson Cancer Center.|
758634|NCT00117962|Between September 2005 and January 2008, 109 participants were recruited.|Six (6) participants cancelled before receiving any protocol related therapy and 2 participants were deemed ineligible; therefore, 101 participants were analyzed.
758635|NCT00117949|The patients were followed until they met a pre-defined criterion for insufficient testosterone or prostate-specific antigen (PSA).|
758636|NCT00117845||
758637|NCT00117806||Two-hundred forty-nine subjects were enrolled in the study which, 48 were excluded for various reasons including benefits (n=19), age >65 (n=10), currently employed (n=6), and other (n=13), leaving 201 subjects. For the purposes of reporting the 44 veterans in the observational site were not included, therefore there are only 157 subjects included.
758638|NCT00117793|Recruitment for this study was conducted at the VA Puget Sound Health Care System (Seattle VA hospital). Recruitment began on March 28, 2007. The study was closed to enrollment on March 30, 2012.|The prostheses used in this study were built and aligned by a certified and licensed prosthetist prior to beginning starting the protocol. 20 individuals gave informed consent but 3 withdrew prior to starting: 1 had contralateral knee surgery, 1 became a bi-lateral amputee, and 1 was withdrawn by the participant's physician.
758639|NCT00117715||
758640|NCT00117676|Participants were enrolled at study sites in North America, Europe, and Australia/New Zealand. The first participant was screened on 07 June 2005. The last study visit occurred on 19 January 2016.|846 participants were screened.
758641|NCT00117637|The start of enrollment was 14 June 2005 and the last day of enrollment was 12 September 2005.|All 189 (97 Sorafenib/92 Interferon) randomized subjects were included in the intent to treat (ITT) population, and 187 (97 Sorafenib/90 Interferon) were included in the safety population according to the protocol, which defined eligibility for safety analyses by the prerequisite that a patient had received at least one dose of study medication.
758642|NCT00117598||September 5, 2007: Sponsor conducted primary analysis of progression free survival. As a result of these preliminary data, participants receiving investigator choice therapy and those receiving 175/25 mg temsirolimus could cross over to receive treatment with 175/75 mg temsirolimus (Protocol Amendment 5).
758643|NCT00117585|341 subjects were recruited. These subjects were recruited from all admits to the rehabilitation unit.|Exclusion criteria included subjects who: couldn't stand, were admitted for respite, and were anticipated to only be on station for less than 7 days.
758644|NCT00117572||
758645|NCT00117559||
758646|NCT00117338|Phase III World Wide (U.S., Europe, Asia, South America, and Lithuania) Multicenter Study. Study Start Date: July 2005 Primary Completion Date: March 2008 Study Completion Date: March 2008|
758647|NCT00117325|The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.|Out of 901 participants screened, 549 participants were screen failures and hence were not randomized into the study. Out of 901 participants screened, 352 participants were randomized from 11 July 2005 to 16 January 2006.
758648|NCT00117312|Participants who responded to degarelix in FE200486 CS06 (NCT00117949) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the US or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS06.|
758649|NCT00117286|Participants who completed the main FE200486 CS14 study were asked to continue into the FE200486 CS14A extension study.|127 participants started and 87 participants completed the main CS14 study. Of these, 57 participants were recruited into the extension study CS14A and 34 participants signed the informed consent for dose shift.
758650|NCT00117156||
758651|NCT00117143|This was a multicenter study conducted in 6 centers in France, the Netherlands, and the United Kingdom.|Participants were enrolled sequentially into one of four dose cohorts. When the platelet count of the first participant who received the 500 μg dose increased above 650 × 10⁹ cells/L following the first dose, this cohort was discontinued, and subsequent participants were assigned to the 300 μg cohort.
758652|NCT00116857||
758653|NCT00116844|From March-2005 to January-2006, 73 participants from 13 centers in the United States were randomized into the study (36 in VALTREX™-Placebo, and 37 in Placebo-VALTEX treatment sequence). One participant in each treatment sequence did not receive study medication and intent-to-treat exposed (ITTE) population was comprised of 71 participants.|Eligible male or female immunocompetent participants in general good health were enrolled. Additionally, participants must be Herpes Simplex Virus Type 2 (HSV-2) seropositive at screening. VALTREX (valacyclovir hydrochloride) is registered trademark of GlaxoSmithKline.
758654|NCT00116831||
758655|NCT00116805|Participants were enrolled at study sites in North America, Europe, and Australia/New Zealand. The first participant was screened on 09 June 2005. The last study visit occurred on 28 January 2016.|603 participants were screened.
758656|NCT00116779||One hundred and seventy-six patients were screened to identify the one hundred and twenty-seven patients who were eligible for randomization.
758657|NCT00116753||
758658|NCT00116688|Participants were enrolled from 2 August 2004 through 15 April 2009|
758659|NCT00116649|Study start - 14 July 2005 at 31 study centers 500 subjects were planned, with up to 15 subjects enrolled at each study center; however, some study centers were unable to enroll 15 subjects, so active centers were asked to enroll additional subjects.|Open-label study - subjects were required to be at least 18 years of age and to have greater than 25 centimeters squared total treatment area(s) containing at least 4 clinically typical, visible, discrete, nonhypertrophic Actinic Keratosis lesions without any dermatological disease and/or condition in the treatment or surrounding area.
758660|NCT00116584|This study was conducted from October 1, 2004 through May 31, 2008 in the emergency department of an urban, tertiary care children's hospital.|
758661|NCT00116558||
758662|NCT00116428|This pivotal study was closed to enrollment on October 12, 2007 with a total of 167 subjects enrolled at 19 investigational sites (15 US and 4 outside US).|
758663|NCT00116337|Subjects were well informed of the details of the study, with particular interest to risks/benefits, and asked to review the Informed Consent before signing.They were given an opportunity to ask questions. Consent was obtained only after all questions and concerns have been addressed.|
758664|NCT00116272|"Participants were recruited concurrently from callers to Organization of Teratology Information Specialists (OTIS) centers, from health care providers and through direct to consumer marketing efforts.
~A third cohort of historical controls including 296 women was also included in the study but are not included in the results of this report."|The first participant was recruited in April, 2005 and recruitment continued through March 19, 2012.
758665|NCT00116207||
758666|NCT00116168|A total of 29 participants provided written informed consent and participated in the study at 2 sites in the United States of America between 10Jun2005 and 18Apr2006.|Eligible participants received MEDI-528 in an open-label manner.
758667|NCT00115934|Subjects undergoing a Norwood were randomized to MBTS or RVPAS at 15 North American centers.|There were no pre-assignment requirements beyond the initial screening criteria.
758668|NCT00115869|Study participants were recruited as 3rd graders in the consecutive years from 40 collaborating school districts in Washington State. The study participants were recruited in 3 waves: Wave I, 6 school districts (1984 and 1985); Wave II, 14 school districts (1985 and 1986); and Wave III, 20 school districts (1986 and 1987).|Forty-two (42) children were not eligible for the study because they were considered by their schools to be developmentally unable to learn.
758669|NCT00115804|Female or male patients from Children's Hospital pediatric outpatient rheumatology clinic were eligible for the trial if they were 13 to 17 years and met study criteria.|Patients who met entry criteria for juvenile fibromyalgia but did not meet any exclusion criteria.
758670|NCT00115778||Eleven subjects were eligible and randomized, and 10 completed all study assessments. One subject discontinued the interventions because of inability to comply with the schedule of study visits. 10 subjects are needed to detect a reduction in the mean number of bacterial infections/patient by one standard deviation over three months with 80% power.
758671|NCT00115765|Participants were enrolled from 10 March 2005 through 19 October 2006.|
758672|NCT00115739|Potential participants at the Comprehensive Cancer Center outpatient Oncology Clinics at the University of Michigan Health Systems were approached with a brief discussion of the study. If interested, a more detailed discussion of the risks & benefits of the study took place with the subject as well as any family members that may have been present.|
758673|NCT00115349|First patient enrolled in August, 2005 and study closed due to low enrollment in June, 2008. 8 participating sites.|Patients were evaluated for eligibility based on the following criterial. If not eligible, they were not randomized to a treatment arm.
758674|NCT00115336|Planned enrollment for the trial was 120 subjects. Accrual was extremely slow; only 10 participants were randomized before the trial was closed in 2008 due to lack of accrual. Less than 10% of planned enrollment was achieved.|
758675|NCT00115297|Recruited from University hospital clinics and inpatient services|Specialist physician confirmed new onset wheezing and completion of study data gathering instruments.
758676|NCT00115063||
758677|NCT00115037|Study participants were recruited through advertisements in the local media, referrals from physicians, or self referrals.|All participants were offered medically monitored outpatient detox as needed.
758678|NCT00114972||
758679|NCT00114959||
758680|NCT00114777||595 participants enrolled, 578 randomized. Reasons for non-randomization included 13 subjects no longer met study criteria; 3 discontinued on sponsor's discretion; 1 due to other reason. Of those randomized, 543 were treated. Reasons for non-treatment were not specified.
758681|NCT00114738||
758682|NCT00114634|October to July 2008|no exclusions
758683|NCT00114530||
758684|NCT00114517||
758685|NCT00114504||
758686|NCT00114244||
758687|NCT00114231||
758688|NCT00114218|This trial was opened to patient entry on March 7, 2005 and was closed to accrual on October 29, 2007|
758689|NCT00114166|Regimen 1 (Topotecan 1.25 mg/m2) recruitment ended early due to lack of interest by institutions.|
758690|NCT00114140||
759061|NCT00003224|patients were enrolled at the University of Virginia|no enrolled patients were excluded.
758691|NCT00114127|Treatment seeking outpatients aged 18 years and older with a primary diagnosis of Generalized Social Anxiety Disorder (GSAD) were recruited by media advertisement.|"Of the 39 participants who completed Phase I of this study, 28 moved on to Phase II.
~1 subject was lost to follow up between baseline and week 1."
758692|NCT00114114||
758693|NCT00114101|From December 2004 and July 2009, a total of 568 participants were recruited to this study.|After registration, participants underwent a peripheral blood stem cell transplant. Of the 568 participants, 460 were randomized to either arm, stratified by beta2 microglobulin, prior thalidomide use and prior lenalidomide use. (108 participants dropped out prior to randomization, most common reasons include: progression, ineligible, refusal)
758694|NCT00113919|This study was conducted at a medical facility. The subjects were recruited from the physician's patient base.|
758695|NCT00113880|Subjects 5 to 49 years of age who were members of the Kaiser Permanente (KP) Health Care Plan at health care centers in Northern California, Colorado, and Hawaii. The first subject vaccinated with FluMist was on 15Oct2003 and the date of the last subject/last assessment was 30Sep2008.|Of 197,502 subjects, 189,174 unique subjects were included in this study, representing the total number of subjects who were defined exclusively within each season. FluMist recipients who received an additional 7,570 FluMist doses were excluded from the analysis based on the presence of high risk underlying medical conditions and other factors.
758696|NCT00113841|Recruitment period: 11/2004 to 1/2008. All participants were recruited at UT MD Anderson Cancer Center.|Of 42 patients enrolled, 9 were excluded from the trial prior to group assignment because of screen failure.
758697|NCT00113763|Participants were enrolled from 16 January 2004 through 16 March 2005. Data are up until the data cutoff of 15 March 2007.|
758698|NCT00113607|This study was conducted in a total of 21 countries at 124 sites worldwide.|672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm) and out of which 9 participants were not treated. 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL.
758699|NCT00113568||
758700|NCT00113555|A total of 10 investigational sites in US and 2 in Canada which were clinics,University hospitals or Research centers implanted patients in this study from the period 2001-2006.A total of 221 patients have been enrolled(218 with enrollment data) and 163 of those patients underwent an implant procedure.|One patient was implanted and was considered a compassionate use patient that did not meet the enrollment criteria.This patient was not included in the efficacy and safety summaries and her adverse vents are recorded.Therefore the total number of implants for the analyses is 162.
758701|NCT00113529||There were 11 subjects enrolled in Phase 1. Phase 2 included 4 subjects from Phase 1 (37.5 mg sunitinib Cohort) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib Cohort), for a total of 35 subjects.
758702|NCT00113516||During Part 1, subjects received carboplatin plus paclitaxel 172-225 mg/m2. Those same subjects were eligible for continuation in Part 2 where they received sunitinib 50 mg. 66 subjects continued in Part 2.
758703|NCT00113490|Children who received at least 3 doses of motavizumab in Study MI-CP104 during the 2004-2005 RSV season were eligible for enrollment in this study. It was anticipated that approximately 150 children would be enrolled.|Motavizumab or palivizumab was administered to children, using a 1:1 randomization, at 15 mg/kg of study drug by IM injection every 30 days, for a total of 4-5 doses (determined by when in the RSV season a child was enrolled) during the 2005-2006 RSV season.
758704|NCT00113425||
758705|NCT00113399||
758706|NCT00113386||
758707|NCT00113373|The study was activated on 5/2/2005 and closed to accrual on 5/1/2006.|
758708|NCT00113360|Recruitment Period: 02/2005 to 07/2006. All participants were enrolled at UT M. D. Anderson Cancer Center.|Three subjects enrolled in the screening portion of the trial did not meet eligibility requirements based on laboratory measurements.
758709|NCT00113334|Recruitment Period: 06/10/05 through 03/02/07. All participants recruited at University of Texas (UT) MD Anderson Cancer Center.|
758710|NCT00113321|Recruitment Period 3/28/05 - 11/7/08; all patients were registered at The University of Texas M.D. Anderson Cancer Center.|Study was terminated due to low accrual.
758711|NCT00113295|One hundred and one individuals were recruited through advertisement and clinical referral from February 2004 to June 2007, signed consent, and participated in a screening visit. Fifty-four individuals (53.5%) with GAD met the study entry criteria and initiated paroxetine CR in phase 1 of the trial.|"Seven patients did not complete phase 1. Of phase 1 completers, 21 were not randomized. Twenty-two patients were randomized, 11 to quetiapine and 11 to placebo augmentation.
~*Note that the data reported throughout the results section are from Phase 2 only."
758712|NCT00113269||
758713|NCT00113230|Recruitment Period: 4/21/05 through 8/31/07. All participants recruited at UT MD Anderson Cancer Center.|
758714|NCT00113217|Recruitment Period: February 22, 2005 to April 4, 2008. All participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.|Of the fifty-two (52), two enrolled participants did not receive treatment and were excluded from the trial.
758715|NCT00113087||
758716|NCT00113022|Patient with major depression who do not have a serious, unstable medical illness and are 21 to 55 years of age may be eligible. Candidates are screened with a psychiatric and medical history, diagnostic interview, physical examination, electrocardiogram, blood tests and, for women, a pregnancy test.|Participants are tapered off anti-depression drugs (and any other medications not allowed) over a 3-week period and then begin a 2-week drug-free period. During these 2 weeks they have an electroencephalogram (EEG) with light stimulation, and those whose EEG indicates a seizure disorder are excluded from the study.
758717|NCT00112957||
758718|NCT00112918||Randomization was stratified according to geographic region and disease stage (high-risk stage II or stage III N1 or stage III N2). The primary analysis population consisted of patients with Stage III disease.
758719|NCT00112905|The study was activated on 10/26/2005. The TCC (transitional cell carcinoma) cohort was suspended for an efficacy evaluation on 10/30/2006 after reaching its first stage accrual goal. A total of 27 patients entered the TCC cohort, and no patient entered the non-TCC cohort. The study was terminated on March 10th, 2008.|
758720|NCT00112866|Patients were enrolled from March 2005 through October 2006. Patients were recruited in the outpatient setting, however patients did need surgery for this study.|
758721|NCT00112840|From 5/11/2005 to 7/19/2006, 14 participants were registered to the Phase I portion of the study (8 at Dose Level 1 and 6 at Dose Level 2). Phase II opened 02/09/2007 at Dose Level 2 and registered 46 patients before closing with full accrual on 6/15/2010.|In Phase I, Dose Level 2, 2 subjects were unevaluable because they were removed from the study before completing cycle 1 of treatment for reasons other than toxicity. In Phase II, 5/46 patients were ineligible and one patient cancelled.
758722|NCT00112736|Patients were enrolled between 2005 and 2008. Patients were recruited from outpatient medical clinics and referrals.|
758723|NCT00112723|Patients were accrued to the study between April 2006 and September 2010.|Patients with confirmed diagnosis of NHL (Non-Hodgkin's lymphoma) were accrued to one of the four cohorts defined by the World Health Organization criteria: indolent B-cell, mantle cell, intermediate-grade B-cell including transformed lymphoma and T-/NK-cell excluding primary cutaneous disease.
758724|NCT00112671||
758725|NCT00112593||
758726|NCT00112489||
758727|NCT00112463||
758728|NCT00112437|Approximately 375 participants were recruited from June 2005 to December 2005. Investigators used one or more of the following recruitment methods: Investigator Patient/Subject Database or Medical Records, Investigator's Local Recruitment/Advertising, Other Health Professional and, Physician Referral (Primary/Specialist/Family Doctor).|Participants entered screening followed by a 3-week placebo run-in. All took vitamin D3, 5600 IU once weekly, those with average daily calcium intakes <1000 mg took calcium 500 mg/day as calcium carbonate. Participants were excluded from the active treatment based on predetermined exclusion criteria (Bone Mineral Density and laboratory results).
758729|NCT00112385|"153 patients were screened and we enrolled and randomized 16 subjects (F 10, M 6) from until February 2006 to May 2009. Of these, 5 were new DM patients and 11 were refractory dermatomyositis patients.
~Etanercept: 11 subjects (New 3, Refractory 8) Placebo: 5 subjects (New 2, Refractory 3)"|"Most patient were initially ineligible because they were not new dermatomyositis patients.
~Due to slow recruitment, we modified the protocol. We allowed enrollment of refractory dermatomyositis patients receiving prednisone for greater than 2 months. These subjects could also receive second line agents, as long as they were on a stable dose."
758730|NCT00112359|Phase 3, double-blind, multicenter, multinational, randomized, placebo-controlled trial evaluating AZLI in patients with CF and PA. Participants were enrolled at 53 sites total: 40 in United States, 5 in Canada, 7 in Australia, and 1 in New Zealand. Date of first enrollment was 10 Jun 2005, and date of last participant follow-up was 3 Apr 2007.|Planned study size was 140 participants to be randomized in a 1:1 ratio to AZLI or placebo TID, with 166 actually randomized (83 AZLI, 83 placebo). However, two participants did not receive a dose of drug, and one participant randomized to receive AZLI received placebo in error. Thus, 80 participants received AZLI and 84 received placebo.
758731|NCT00112294||755 participants were enrolled and 676 were randomized into the study. 79 participants were not randomized (6 deaths; 1 lost to follow up; 1 poor/non-compliance; 49 no longer met study criteria; 17 participant request; 2 required concurrent radiation; 1 insurance issue; 1 doctor discretion; 1 unknown).
758732|NCT00112242|Subjects were screened and enrolled at 2 sites in Switzerland, the CHUV in Lausanne and the HUG in Geneva.|The assignment to a group was done according to tumor antigen (i.e., Melan-A, MAGE-A10, NY-ESO-1b[A]) and HLA expression (HLA-A2).
758733|NCT00112151|Recruitment from January 2005 through August 2009 of community dwelling men >=60 years of age in the Denver metropolitan area with active attempts to recruit men from all ethnic populations.|see eligibility criteria
758734|NCT00112125||
758735|NCT00112112|A total of 20 participants, 10 in the FluMist group and 10 in the placebo group, were enrolled in the study between 08Aug2005 and 31Mar2008 at 4 sites in the USA.|A total of 20 participants were randomized in a 1:1 ratio to the FluMist or placebo group. Participants were enrolled on a staggered schedule to assess safety. Four participants were enrolled and treated in 2005, 8 in 2006, and 8 in 2007; each subset was assessed for vaccine-related serious adverse events prior to enrollment of the next subset.
758736|NCT00112047|Participants were enrolled at 70 study sites in the United States and Europe. The first participant was screened on 29 July 2003; the last participant was randomized on 16 January 2004; the last participant observation for the primary endpoint analysis was 11 February 2005; the last participant last visit for end of study analysis was 10 June 2009.|Of the 517 enrolled participants, 6 received no study drug (the safety analysis set was therefore 511 participants: 257 [efavirenz+emtricitabine+tenofovir disoproxil fumarate group] and 254 [efavirenz+combivir group], respectively).
758737|NCT00111917|We aimed to enroll 20 CBD subjects on stable doses of corticosteroids and/or methotrexate, with no evidence of active or chronic infection, malignancy, other chronic disease, or past treatment with another biologic with a 3:1 infliximab:placebo ratio|the sponsor stopped the study due to slow recruitment
758738|NCT00111839||
758739|NCT00111813||
758740|NCT00111800|The study was conducted from 28 April 2005 to 21 July 2006 across 94 centres from 9 countries.|A total of 375 participants received denagliptin ([DEN] 2.5, 7.5, 15, 30 or 45 milligram [mg]) or placebo which constituted the Safety Population. A total of 318 entered extension phase of study; 3 participants completed main phase but did not enter extension phase.
758741|NCT00111761|Participants were enrolled from 19 Jul 2002 through 20 April 2004|
758742|NCT00111657||
758743|NCT00111475|"This study consisted of 2 parts. Part A (conducted from July 1, 2002 to October 13, 2003) was an open-label, dose-escalation trial with sequential cohorts of participants.
~Part B (conducted from October 6, 2003 to June 17, 2004) was a double-blind, placebo-controlled, parallel design study."|In Part A participants were sequentially assigned to escalating dose cohorts. In Part B, participants were randomized to each dose cohort; within each cohort 2 of 10 participants were randomly assigned to receive placebo. The 6.0 µg/kg dose cohort was discontinued in protocol amendment 4.
758744|NCT00111241||
758745|NCT00111228||
758746|NCT00111007|The study was conducted from May 4 2005 to Jan 08 2009 (first subject's first visit to last subject's last visit) at 54 centers in 7 countries: Australia (6), Canada (6), France (6), Germany (10), Netherlands (2), United Kingdom (8), and United States (16).|Of 315 screened subjects, 270 were randomized (45 failed screening) and were valid for Intent-To-Treat (ITT) analyses (135 in each treatment group). One subject in each group did not receive treatment: 1 died and 1 withdrew consent. Thus, 268 subjects received treatment (134 in each group) and were valid for the safety analyses.
758747|NCT00110994|A total of 121 subjects were enrolled at 17 centers in the United States. There were 20 screening failures; 12 subjects did not meet 1 or more entry criteria, 4 subjects withdrew consent before randomization, and 4 subjects were not randomized for other reasons. 101 subjects were randomized between 21 Mar 2005 and 27 Apr 2006.|A total of 101 subjects were randomized (50 to Placebo + Dacarbazine (DTIC) and 51 to Sorafenib + DTIC) and were included in the population valid for intent to treat (ITT) analyses. All randomized subjects received study drug and were included in the population valid for safety analyses.
758748|NCT00110890|Participants were enrolled from 28 May 2004 through 12 November 2004|
758749|NCT00110812|Participants were enrolled by HIV care providers between December 2005 and June 2008. When the main study ended in February 2009, patients who consented to a study extension were followed another 2 years, during which study drug was not given.|
758750|NCT00110617||212 participants were enrolled in the study; however, 9 participants from Site 512 were excluded due to severe Good Clinical Practice (GCP) violations. 203 participants are included in the Full Analysis Set 1.
758751|NCT00110513|The study population included non pregnant patients who were scheduled for surgery and pregnant patients who were scheduled for caesarean section or delivery induction or were hospitalized in active labor.|Eighteen patients were treated with recombinant human antithrombin (rhAT) and analyzed for safety.
758752|NCT00110461|Participants were recruited from 59 centers in the United States between March 2005 and February 2007. A total of 413 subjects were screened for enrollment, with 296 subjects assigned to double-blind treatment.|Participants were screened over a 28-day period.
758753|NCT00110396|Participants were enrolled from 25 Jan 2005 and attended the last visit on 16 April 2007. Two hundred and eighty two participants were screened for enrollment and 260 were enrolled.|Screening phase of up to 28 days before the start of interferon-beta-1a treatment. There were 47 centres in: Argentina (5), Australia (4),Canada (1), Denmark (1),Ireland (2), Israel (2), Lithuania(2), Russia (10), Spain (4), Sweden (1), UK (5) and US (10). 1 additional centre in Australia screened 1 participant who was not enrolled into the trial.
758754|NCT00110357||48 subjects were enrolled; 1 additional subject withdrew informed consent before any measurements or treatment. 46 subjects (27 in the 1- to 12-yrs-old group and 19 subjects in the 13- to 18-yrs-old group) were treated; 2 subjects in the 13-18 yrs group were not treated, and are NOT included in Participant Flow or Baseline Characteristics tables.
758755|NCT00110305|368 participants were enrolled at multiple centers in different countries.|368 participants were randomly assigned to 4 treatment groups (TMC278 25 mg: 93; TMC278 75 mg: 95; TMC278 150 mg: 91; and Efavirenz: 89). Participant flow through Week 240 was reported for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.
758756|NCT00110214|Between May 2005 and December 2007, 1,050 participants were recruited and randomized|
758757|NCT00110149||12 patients were recruited and signed consent. 3 patient were ineligible and were not treated. The total number treated is nine
758758|NCT00110136|Study was open between 3/16/2006 and 4/1/2008. The nine patients were accrued between 11/06 and 2/08.|
758759|NCT00110084|Participants were recruited from 22 medical clinics in the United States between November 2005 to May 2006|
758760|NCT00110019|This study was activated on June 23, 2005, and terminated on April 22, 2008 with the final accrual of 823 patients. Most of patients were accrued through Eastern Cooperative Oncology Group (ECOG), Cancer and Leukemia Group B (CALGB), and Southwest Oncology Group (SWOG). Other Clinical Trials Cooperative Groups also participated.|
758761|NCT00109967|Seventy-one patients seen at 35 sites were enrolled on this trial between May 6, 2005 and March 6, 2009. Two patients canceled before receiving treatment and 69 patients were therefore included in the analysis. There were 48 patients in group 1 (rituximab-sensitive) and 21 (rituximab-refractory) in group 2.|The patients were stratified by their previous response to rituximab into rituximab sensitive (group 1) or rituximab refractory (group 2) groups. Rituximab refractory was defined as no response (stable disease or progression) or a response that lasted <6 months the last time the patient received rituximab alone or rituximab with chemotherapy.
758762|NCT00109928||
758763|NCT00109876|Fifty-four (54) participants were enrolled from 16 institutions from December 2006 to November 2010.|Two participants had pre-RFA positron emission tomography (PET) not within 60 days before study preregistration and one participant did not had non-small cell lung cancer, which were deemed ineligible for the studies, and were excluded from all analyses.
758764|NCT00109850||
758765|NCT00109837||
758766|NCT00109772||A total of 184 participants were randomized to the study and 180 participants received at least 1 dose of study drug.
758767|NCT00109733|Study Initiation Date: 06 Jan 2005 (date of first subject, first dose) Study Completion Date 11 Jun 2006 (date of last subject, last visit) 19 study centres in the United States received IRB approval to participate in this study; 13 of the centres enrolled at least one subject into the study.|All study screening assessments were to be performed within a 30-day period prior to study entry. A total of 40 subjects were screened for the study and 31 of them (77.5%) were randomised and received study drug.
758768|NCT00109590|Study participants were enrolled at seven IMPAACT affiliated sites in Thailand. Between June 9, 2006 and June 30, 2008, 175 participants enrolled in the study.|The study recruited HIV infected pregnant women who were >= 18 years of age,>=28 to <38 weeks gestation, who did not plan to start antiretroviral treatment within eight weeks following delivery, not planning to breastfeed and had CD4+ count >250 cells/mm3. Women were randomized in approximately equal numbers to one of three treatment arms.
758769|NCT00109577||
758770|NCT00109473|98 subjects were assessed for eligibility, 76 did not meet inclusion criteria, 21 refused to participate|21 subjects enrolled, one withdrew consent prior to randomization.
758771|NCT00109343|"24 clinical sites in the United States
~Date first participant visit: 06-Mar-2006
~Date last participant visit: 14-Sep-2007"|
758772|NCT00109031||
758773|NCT00109005||
758845|NCT00104572||The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
759363|NCT00068822|Participants were enrolled at five centers in the U.S., five centers in the United Kingdom and one center in Australia.|
758774|NCT00108953|Enrollment started on 13 Apr 2005 and the last study contact occurred on 11 Apr 2008. The study was conducted at 25 active centers in 6 countries (Argentina, Canada, Hong Kong, Russia, United Kingdom, and United States.)|140 patients were screened, with 44 screen failures. The intent-to-treat (ITT) population (primary efficacy analysis) includes all randomized patients (96). The Safety population includes all patients who received at least 1 dose of study drug (95). The study consists of 2 periods: treatment period (not fixed but ended by any event) and follow-up.
758775|NCT00108862|Study participants were recruited at 26 sites from 13 countries: 4 each from U.S. and South Africa; 3 from Brazil; 2 each from Peru, Botswana, Kenya, Malawi, and India; and 1 each from Haiti, Uganda, Zambia, Zimbabwe, and Thailand, between September 2006 and August 2009.|HIV-infected persons at least 13 years of age, naive to antiretroviral therapy, who had received 1-14 cumulative days of a rifamycin-based TB regimen within 28 days prior to study entry, and had a CD4 count <250 cells/mm3. Randomization was stratified by screening CD4 (<50 vs =>50). Three participants were deemed ineligible and taken off study.
758776|NCT00108732|"The study was activated on February 3, 2006 and terminated on December 11, 2007 after reaching its accrual goal. A total of 50 patients were recruited from ECOG member institutions.
~Patients with biochemical or clinical progression during Step 1 were eligible to receive androgen blockade in Step 2. To date, 31 patients have registered to Step 2."|
758777|NCT00108628||Ten participants dropped out prior to randomization.
758778|NCT00108550|Dates of recruitment were January 2005 to June 2009 by newsprint advertisements to the general community, by word-of-mouth, and posting of flyers at primary care clinics at two performance sites (VA San Diego Healthcare System and University of Califonia Medical Center, San Diego).|
758779|NCT00108524|Participants were recruited from outpatient clinics affiliated with the Department of Veterans Affairs Medical Center in Durham, North Carolina, between April 2005 and October 2006.|18-70yo,BMI 27-30+obesity-related disease or BMI>30 regardless of comorbidity. Excluded:weight loss in <30 days;pregnant,breastfeeding,DM-1;unstable heart disease or psych illness,dementia,substance abuse;HTN >160/100; creatinine>1.5men,>1.3women; HemA1c>11%; triglyceride>600; LDL-C>190. Not considered enrolled if not told group assignment (n=14).
758780|NCT00108485||
758781|NCT00108433||
758782|NCT00108355|Between October 2003 and June 2010, about 200 patients with cirrhosis and ascites were screened, of which, only 29 met inclusion criteria. Twenty five patients (13 control, 12 study group) were included in the analysis.|
758783|NCT00108342||25 enrollees gave their signed consent and were then screened for participation; a total of 17 participated in testing.
758784|NCT00108303||
758785|NCT00108277|Participants were recruited from October 2005 to September 2008 from the local VA medical center and surrounding community. Participants were primarily recruited via posted flyers and other public advertisements (e.g., ads in local newspapers).|
758786|NCT00108160|Patients with a history of documented infection with Staphylococcus aureus cared for at Veterans Affairs Ann Arbor Healthcare System, University of Michigan Medical Center, St. Joseph Mercy Hospital (Ypsilanti, MI), and Pittsburgh VA Medical Center from April 2005-August 2012.|Patients who met study criteria and signed an informed consent were enrolled and randomized to treatment with mupirocin 2% in polyethylene glycol (PEG) ointment or treatment with a placebo (polyethylene glycol) ointment
758787|NCT00108082||Following screening, 413 participants were enrolled into the study to begin an open-label run-in phase with lisinopril 10 mg once daily (OD) for 1 week and then lisinopril 20 mg OD for 1 week. Of these participants, 287 were randomized to 1 of the 3 treatment regimens.
758788|NCT00108069||
758789|NCT00107991||
758790|NCT00107978|Enrollment Period: 18 February 2005 to 31 May 2006|
758791|NCT00107952|Enrollment Period: 08Feb05 to 11Jul07|
758792|NCT00107900||
758793|NCT00107783|Patients were enrolled at the NIH Clinical Center between April 2005 and March 2006.|
758794|NCT00107744||
758795|NCT00107653|A total of 569 participants were recruited at 52 centers in the United States in the study conducted from 26 October 2004 and 07 September 2007.|Out of 1038 screened participants, 569 were enrolled and 469 were screen failures because of eligibility criteria was not met. Of the 569 enrolled participants, 269 participants were assigned to Latino and 300 participants were assigned to non-Latino White group.
758796|NCT00107614||
758797|NCT00107575||
758798|NCT00107536|Patients were enrolled between the dates of March 3, 2006-May 14, 2007.|
758799|NCT00107380||
758800|NCT00107315||
758801|NCT00107276|Between 8/15/2005 and 9/1/2007, 112 patients were registered from 26 SWOG institutions who obtained Institutional Review Board (IRB) approval for the study.|
758802|NCT00107198||
758803|NCT00107172|Two hundred twenty-four (224) participants were accrued between January 2006 and January 2010.|One participant on SR arm was enrolled from a site with a regulatory violation and 1 participant on SR+BX arm had no surgery. These two participants were excluded from all analyses.
758804|NCT00107120|Recruitment period was from April 1, 2005 through March, 2007 at 40 centers in the US.|2 week screening with one-week single-blind placebo. Patients meeting selection criteria at baseline were randomized to once daily escitalopram 10-20mg/day or placebo (1:1).
758805|NCT00107042|The study was started in February 2004 and was completed in July 2008. A total of 11 sites, all in the United States and Puerto Rico, participated in the study.|
758806|NCT00106964|This is a multi-site study. Accrual was open between April 2006 and January 2008. Participants were enrolled in the United States, South Africa, Brazil, and the Bahamas.|Subjects were randomized into one of three arms using blocks of six and stratified by absolute CD4 count (less than 500 and 500 cells/mL or greater) and previous hepatitis B virus (HBV) vaccination (0,1). The randomization was restricted so that the percentage of subjects with CD4 count < = 200 cells/mL would not exceed 15% of subjects on any arm.
758846|NCT00104520|Participants were enrolled at 56 sites in the United States. Date of first enrollment was 24 February 2005, and date of last participant follow-up was 07 September 2006.|Subjects were randomized in 1:1:2:2 ratio to placebo twice a day (BID) or three times a day (TID) and AZLI BID or TID, respectively. A total of 211 subjects were included in the ITT analyses: 38 placebo BID, 38 placebo TID, 69 AZLI BID, and 66 AZLI TID. All analyses were conducted on pooled placebo (n = 76) versus pooled AZLI (n = 135) groups.
758807|NCT00106938|Asymptomatic subjects with extracranial internal carotid stenosis which was ≥70% & ≤99% by duplex ultrasound or ≥70% & ≤99% by angiography (visual estimate) with or without involvement of the contiguous common carotid artery, who could undergo carotid artery stenting/carotid endarterectomy and all follow-ups, were recruited starting from April 2005|1453 patients were randomized to support the primary analysis; an additional 210 lead-in subjects were enrolled to allow investigators to gain experience with the study devices prior to randomizing subjects and were not part of the primary analysis.
758808|NCT00106704|First Patient In: 27-Apr-2005. Last Patient Last Visit: 09-Jan-2007. 27 medical clinics in the United States (US), 25 in 11 countries in Europe, and 22 in 11 countries in the rest of the world.|Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (hemoglobin A1c [A1C] ≥7.5% and ≤10.5%) at screening or after treatment with glimepiride (≥4 mg) alone or in combination with metformin (≥1500 mg) for a dose stable period of up to 10 weeks were eligible to participate.
758809|NCT00106639||
758810|NCT00106626|First Patient In = 29-Aug-05. Last Patient Last Visit = 03-Dec-07. Multicenter (4 Outpatient Clinics) in US.|"Post-group assignment information: For all cohorts doses were administered in repeated 21-day cycles.
~Determination of the Maximum Tolerated Dose (MTD), by using dose-escalating design and measured by Dose Limiting Toxicity (DLT) is a standard procedure in the development of chemotherapeutic combinations."
758811|NCT00106535||This study was divided into two phases: a 2-year core placebo controlled treatment phase and an optional 3-year extension phase.
758812|NCT00106431|Patients were enrolled between January 2005 and July 2007. Patients were enrolled at academic centers in the US and Europe that had experience in treating CTCL patients|Eligible patients were required to have failed at least 1 prior systemic therapy, e.g., interferon, chemotherapy, Ontak® (denileukin diftitox), or Targretin® (bexarotene).
758813|NCT00106392||
758814|NCT00106353||
758815|NCT00106249||
758816|NCT00106184|Subject were screened and enrolled at 26 US and 4 international sites.|In an effort to exclude IBM (Inclusion Body Myositis) and other myositis mimics, the medical records and muscle biopsy results (if available) of adults with PM were reviewed by a 3-member Adjudication Committee before enrollment.
758817|NCT00106119|Participants recruited from NIH Clinical Center, Bethesda, Maryland, USA between June 2005 and November 2007.|110 participants inquired through phone; 24 screened, 10 excluded 8 did not meet inclusion criteria and 2 refused participation).
758818|NCT00106106||
758819|NCT00106080||Patients gave written informed consent before enrollment.
758820|NCT00106028|147 children > or = 4 and < 16 years of age with Osteogenesis Imperfecta (OI) enrolled at 20 North American and international study centers starting 16NOV2004. Patients weighing 10-30 kg received risedronate 2.5 mg or placebo daily and patients weighing more than 30 kg received risedronate 5 mg or placebo daily.|
758821|NCT00106002||
758822|NCT00105989||The Acute - Open Label (Week 0-10) participants were reported in the Baseline Characteristics section of this results record.
758823|NCT00105586|257 subjects consented (177 randomized and received treatment)|78 excluded from randomization due to ineligibility and/or refusal; 2 excluded after randomization but did not start treatment
758824|NCT00105560||
758825|NCT00105534||
758826|NCT00105521||
758827|NCT00105508||
758828|NCT00105482||
758829|NCT00105469||
758830|NCT00105443|Subjects with advanced hepatocellular carcinoma (HCC) were enrolled from Mar 10, 2005 to Apr 11, 2006 at 121 study centers in 21 countries around the Globe.|After a 28 day screening period (902 subjects), 602 were randomized to Sorafenib (400 mg) twice daily (bid), or matching placebo. Majority of screen failures did not meet inclusion criteria. Efficacy population (intent-to-treat, ITT) was all randomized subjects (602), safety population was all subjects receiving at least 1 dose of study drug (599).
758831|NCT00105235|Recruitment details: Eight centers in the United States and one center in Canada enrolled 27 participants with end-stage liver disease who met entry criteria between February 2005 and May 2006.|
758832|NCT00105196||After initial screening period (7-28 days), subjects enrolled into an 8-wk prospective treatment phase (single-blind placebo plus an investigator-assigned, open-label, marketed antidepressant therapy [ADT]). Patients who met criteria for incomplete response at the end of this phase were randomized into the 6-wk double-blind phase in a 1:1 ratio.
758833|NCT00105183||
758834|NCT00105157|"Primary therapy period: 22-Apr-2005 to 09-Nov-2006
~Multicenter (31) in the United States (15) and outside the United States (16)"|Patients failed prior antiretroviral therapy (HIV RNA >5000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase inhibitors and Protease Inhibitors). All patients must have met laboratory criteria.
758835|NCT00105079|This study was conducted between 28 April 2005 and 24 August 2007 at 38 study centers in the United States, Canada, France and Thailand. Patients were randomized to receive saquinavir/ritonavir 1000/100 mg PO BID plus emtricitabine/tenofovir 200/300 mg PO QD or lopinavir/ritonavir 400/100 mg PO BID plus emtricitabine/tenofovir 200/300 mg PO QD .|
758836|NCT00105066||
758837|NCT00105027|"Between November 8, 2004, and February 29, 2008, 271 patients with central retinal vein occlusion (CRVO) were enrolled from 66 clinical sites and 411 patients with branch retinal vein occlusion (BRVO) were enrolled from 75 clinical sites across the United States.
~Participant flow data are reported for the primary outcome measure (12 months)."|
758838|NCT00105001||
758839|NCT00104884|The study was activated on January 11, 2005, and terminated on May 17, 2006 due to slow accrual. Four patients were enrolled.|
758840|NCT00104871|Recruitment Period: December 2004 to April 2010. Recruitment done in medical clinics.|Of the 24 participants enrolled, two participants were not eligible and excluded from the study.
758841|NCT00104858||
758842|NCT00104728||
758843|NCT00104650|Participants were enrolled from 2 December 2004 through 30 March 2007|
758844|NCT00104637|The recruitment period began in February 2005 and ended by November 2008.|
758955|NCT00096356|Recruitment period: Opened 08-27-04, Closed 03-09-09. Recruitment occurred in medical clinics|There was no run-in period. Everyone enrolled was randomized.
758956|NCT00096278||
758847|NCT00104416|All participants (par.) that complete the Treatment Phase (TP) and all Baseline Failures (par. who did not meet randomization seizure criteria necessary to qualify for the TP) are eligible to enter the Continuation Phase (CP). The CP is for long-term safety exposure to lamotrigine (LTG) extended release (XR); it is not a cross-over phase.|"The number of par. starting the CP does not equal the number completing the TP, as 1) the CP was optional, 2) not everyone from the TP was eligible to enter the CP, and 3) Baseline Failures were allowed to enter the CP, however they were not included in the started count for the TP."
758848|NCT00104299|Eight centers in the United States and one center in the Netherlands (Groningen) enrolled 197 Antineutrophil cytoplasmic antibodies (ANCA)-positive patients with either Wegener's granulomatosis or microscopic polyangiitis between December 30, 2004 and June 30, 2008.|At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form.
758849|NCT00104247||
758850|NCT00104234|"Global study sites were hospitals and medical clinics.
~First Enrollment: 05FEB04
~Last Dose: 28SEP06"|
758851|NCT00104104||
758852|NCT00104052||
758853|NCT00103857|"First Patient In: 01-Apr-2005
~Last Patient Last Visit: 29-Feb-2008
~140 study centers worldwide"|Patients 18-78 years with T2DM and an HbA1c 7.5-11% on diet/exercise were eligible for randomization into the 54-week (wk) base study. Patients with an HbA1c >11% or glucose >280 mg/dL were eligible to participate in the Open-label Cohort through Wk 24. Randomized patients who completed the base study were eligible to enter a 50-wk extension study.
758854|NCT00103844||166 subjects enrolled; 16 failed screening and were not treated (2 subjects were double-randomizations, 13 subjects failed inclusion criteria, 1 subject withdrew consent during screening.)
758855|NCT00103740||371 patients were screened. 185 patients were randomized.
758856|NCT00103662|Participants with multiple myeloma (MM) eligible for autologous hematopoietic stem cell transplant were recruited from 40 centers (38 in the U.S., 1 in Germany, 1 in Canada). The first participant was randomized on 04 February 2005 and the last participant's last study visit occurred on 22 January 2008. A total of 302 participants were randomized.|
758857|NCT00103610|Participants with non-Hodgkin's lymphoma (NHL) eligible for autologous hematopoietic stem cell transplant were recruited from 31 centers in the U.S. and 1 in Canada. The first participant was randomized on 18 January 2005 and the last participant's last study visit occurred on 20 December 2007. A total of 298 participants were randomized.|
758858|NCT00103506||
758859|NCT00103402||
758860|NCT00103376||
758861|NCT00103311||
758862|NCT00103285||
758863|NCT00103259|E1304 was open to accrual on July 20, 2005 and was suspended on September 29, 2006. The trial was reactivated on October 18, 2006 with dose reduction for irinotecan. Arm I was closed with 27 patients after stage I. Arm B proceeded to the second stage of accrual without suspension and closed on September 24, 2008 after enrolling 44 patients.|
758864|NCT00103207|The study opened to accrual on August 10, 2005 and closed to accrual on December 12, 2008 with final accrual of 72 patients.|
758865|NCT00103194|Participants were recruited from ECOG member institutions between September 29, 2005 and July 5, 2006.|
758866|NCT00103142|This was a 7 site study where patients were recruited from medical clinics and the patient's primary oncologist and study team approached the patient about the study. Patients were recruited for this study from January 2005 and September 2009.|The study was designed to treat 72 subjects. Total number of enrollment is 74 because enrollment reflects the number of subjects that signed consent and were randomized to the study but did not necessarily receive study drug or complete study drug.
758867|NCT00103116|Non-randomized open label; stage I-IIIB NSCLC. Closed to accrual in 2006 when defined phase I immunological endpoints were reached.|None excluded; all completed.
758868|NCT00103012|Healthy human volunteers were recruited to participate in this study throughout the course of the investigation (2005-2010).|
758869|NCT00102960||The results are presented for only 377 participants that were enrolled into the three arms (ART-Def 125, ART-40W 126 and ART-96W 126).
758870|NCT00102804||Participants who signed the informed consent form (ICF) and completed the randomized process are presented in the participant flow by the treatment arm to which they were randomized. Participants who did not sign the ICF or complete the randomization process were removed from the database and excluded from all analyses.
758871|NCT00102687||One hundred and eighty-four patients were screened.
758872|NCT00102596||
758873|NCT00102531||
758874|NCT00102518|Participants were recruited from 157 centers in Argentina, Bulgaria, Croatia, India, Jamaica, Mexico, Romania, Russia, Serbia, South Africa, South Korea, Ukraine, and the United States between September 2004 and February 2007. A total of 325 subjects were screened for enrollment and all 325 subjects were enrolled.|All participants had previously completed NCT00102063 (OPDC 31-03-239, adolescents with schizophrenia) or had withdrawn from the double-blind extension phase of NCT00110461 (OPDC 31-03-240, children and adolescents with bipolar 1 disorder), both clinical studies of aripiprazole.
758875|NCT00102440|Subjects were enrolled at 112 investigative sites, 106 in the United States and 6 in Canada, from 11 July 2002 to 20 February 2004.|Subjects currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollment in once daily (QD) treatment groups.
758876|NCT00102063|Participants were recruited from 101 centers in the United States, Europe, South America, the Caribbean, and South Africa between August 2004 and August 2006.|Participants were screened over a 4-week period.
758877|NCT00101933|157 subjects were enrolled in the study from 11 DEC 2003 through 23 FEB 2007 from 17 centers in US.|47 of 157 subjects exited prior to implant due to not meeting in/exclusion criteria, withdrawal of consent to participate, etc. Of the remaining 110 subjects, 109 subjects were randomized. Those 109 subjects were used for objectives between randomization groups while all 110 implanted subjects were used for long term safety objectives.
758878|NCT00101907|Participants were enrolled from 2 December 2004 through 7 March 2007. This study was designed with two parts. However, Part 2 was not conducted due to safety issues found in Part 1. Thus Part 1 is referenced as the overall study here.|
758957|NCT00096265||
758958|NCT00096226||
758959|NCT00096200|Patients accrued from medical clinic from August 2004 through June 2011|
758879|NCT00101868|127 hospital physicians assessed for eligibility: 49 excluded for insufficient assignment time on inpatient service, 6 declined informed consent, 2 for other reasons. 6884 inpatients screened between November 2004 and January 2007. 6253 patients were not eligible by protocol exclusion criteria.|
758880|NCT00101816||A total of 124 participants were enrolled in this study; 15 were never treated (11 participants did not meet inclusion criteria; 3 participants died; 1 participant failed screening).
758881|NCT00101686||
758882|NCT00101660||
758883|NCT00101647||197 participants were enrolled into the study; 23 participants were not treated (3 participants died, 13 participants no longer met study criteria, 3 participants switched into other studies, 2 participants had adverse events, 1 participant excluded for administrative reasons, and 1 participant withdrew consent).
758884|NCT00101582|This study was conducted from 03 August 2005 (first participant enrolled) to 11 September 2007 (last participant's last visit at 4 months of follow-up) at 46 study centers in the United States, Canada, and Europe At the time of this report, the long-term safety follow-up period is ongoing.|
758885|NCT00101452|Participants were recruited through general advertising at both the Depression Clinical and Research Program of MGH in Boston, MA and Butler Hospital in Providence, RI. Recruitment also took place at Family Doctors, LLC, in Swampscott, MA. We began recruiting participants in April 2005 and closed the study in December of 2009.|Only five participants completed the allowed wash-out period prior to randomization. Participants screened at Day 0-7 and were asked to return for a baseline visit at Day 0. Subjects not randomized were excluded for being ineligible at the baseline or for being lost to follow-up between screen and baseline.
758886|NCT00101439||
758887|NCT00101413|Study conducted in Germany and USA (1 center each) from Apr 2004 to Jun 2005. Recruitment in 2 phases: Interim analysis (IA) to be performed after treatment of 29 patients; final analysis planned after additional 21 patients. Final analysis data cut-off date 30 Jun 2005; safety data collected for the 4 ongoing subjects until 11 Apr 2008.|52 of 54 enrolled patients started treatment. The analysis population consisted of 52 subjects for the intent to treat (ITT) and safety analyses and 51 subjects in the evaluable subject analysis (1 had lung metastases from pancreatic cancer).
758888|NCT00101400|Subjects were enrolled from 03 Feb 2004 to 29 Jul 2004 by 3 centers in Germany and 4 centers in Italy.|2 subjects were excluded during screening phase: 1 withdrawal of consent and 1 protocol violation.
758889|NCT00101361|enrollment started 08/01/2005 and ended 10/10/2008 at 15 VA Medical Centers. Subjects were randomized only after a four week screening phase.|Potential participants were screened for four weeks to determine eligibility based on documentation of a difficult-to-heal or worsening status of the pressure ulcer as an inpatient.
758890|NCT00101283|The study was activated on November 1, 2005, suspended to accrual on July 12, 2007 for response evaluation, and closed to accrual on April 1, 2008.|
758891|NCT00101192||
758892|NCT00101166|43 patients with Stage IV melanoma were enrolled between November 2004 and May 2007. Fifteen of these patients did not receive any vaccine.|
758893|NCT00101101|Forty three patients with stage II-IV histologically confirmed mantle cell lymphoma (MCL) in need of systemic chemotherapy were enrolled at the H. Lee Moffitt Cancer Center between February 2004 and July 2008.|
758894|NCT00101036||
758895|NCT00101010||
758896|NCT00100932|This study was recruited at 29 centers in the US during the period of Dec 2004 to Apr 2006.|
758897|NCT00100841|A total of 67 patients were enrolled from between December 2004 and November 2006|One patient was enrolled but never started treatment
758898|NCT00100828||
758899|NCT00100815||
758900|NCT00100802||
758901|NCT00100789||
758902|NCT00100698|Patients with HIV and lipodystrophy were recruited between November 2003 and March 2006 via community advertisement, HIV support and advocacy groups, and infectious disease or primary care physician referral.|Patients who do not meet growth hormone inclusion criteria were excluded from the trial before assignment to groups.
758903|NCT00100659|December 2004 to May 2006 at 11 US medical centers|Failure to meet inclusion criteria
758904|NCT00100230||
758905|NCT00100178|Thirteen Clinical Centers at academic institutions recruited and enrolled 126 subjects ages 8 to 45 years with autoimmune T1D for less than 3 months.|Subjects were screened for evidence of autoantibodies and c-peptide >0.2 pmol on a stimulated 2 hr Mixed Meal Tolerance Test to determine eligibility for the study.The MMTT must be conducted at least 21 days from the diagnosis of diabetes and no more than one month (37 days) prior to the date of randomization.
758906|NCT00100165|Thirty-four subjects were screened. Two were excluded because of abnormal laboratory values and one was excluded for a recent hospitalization. Thirty-one subjects were enrolled at two sites: The University of Colorado, Denver/Denver VA Medical Center (25 subjects) and The Maryland Psychiatric Research Center 6 subjects.|Subjects were administered 1 week of placebo to assess their ability to comply with BID dosing prior to administration of drug or placebo. There was a 1 week washout period between arms.
758907|NCT00100048|"Primary therapy period:
~For Part I (10 day monotherapy): 24-Jan-2005 to 04-May-2005
~Part II (Dose Ranging): 14-Jun-2005 to 04-Oct-2006 (48 weeks); 14-Jun-2005 to 12-Jul-2010 (240 weeks)
~Multicenter (29) in the United States (14) and Ex-US (15)"|"Patients with Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) of at least 5000 copies/mL and cluster of differentiation 4 (CD4) cell counts of at least 100 cells/mm3. All patients must have met laboratory criteria.
~206 enrolled; 5 from Cohort I did not continue to the combination phase. Therefore 201 entered the combination phase."
758908|NCT00099983|Patients were recruited initially from 20 VA Medical Centers over a 2-year period. To address low recruitment rates and other issues, 8 sites were discontinued and 6 sites were added during the course of the study.|
758909|NCT00099632|Study participants were recruited at 8 sites: 2 from South Africa, 2 from India, and 1 each from Haiti, Uganda, Tanzania, and Malawi, between January 2007 to October 2009.|"62 participants who randomized but did not start study treatment were excluded from the analysis. These 62 participants were either off study prior to delivery or delivered on study but did not take any dose of study treatment.
~All the analyses were restricted to the 422 women who received study treatment."
758910|NCT00099437||
758911|NCT00099359|The first subject was enrolled on 02/27/2004 and the study ended 02/28/2011. A total of 17 sites in Brazil, South Africa, Argentina and the U.S. participated in the study.|
758912|NCT00099268||
758913|NCT00099047|23 asymptomatic adult patients with a serum monoclonal protein >1g/dL from Cleveland Clinic, Mayo Clinic, or University of Arkansas Medical Center were randomized between August 2005 and April 2008|There were no significant events or approaches utilized following enrollment but prior to group assignment.
758914|NCT00099021||
758915|NCT00098956||
758916|NCT00098865|15 patients were enrolled between 2002 to 2007 at the Dana-Farber Cancer Institute.|For pediatric patients with relapsed or progressive brain tumors and neuroblastoma.
758917|NCT00098839||The phase I part of the study was completed as of August 2006. The study was amended on 11/10/2006 and Part B (phase 2 pilot) was opened on 01/08/2007 which consisted of two dosing schedules for epratuzumab: weekly for four doses during Block 1 and twice weekly for eight doses during Block 1. This report is limited to Part B (116 enrollments).
758918|NCT00098813|Protocol Open to Accrual 10/12/2004 Protocol Closed to Accrual 04/22/2008 Primary Completion Date 08/11/2009 Recruitment Location is the medical clinic|
758919|NCT00098787|This study was activated on July 14, 2005 and terminated on April 20, 2012, with 247 patients from 25 institutions enrolled to the study.|Only 211 patients were registered to the treatment phase of the study, while the other 36 did not proceed because of ineligibility (n=9), patient withdrawal (n=6), unknown thymidylate synthase (TS)/insufficient sample (n=3), disease progression/decline in TS (n=2), Arm C suspended could not enter Step 2 (n =15), and no insurance (n =1).
758920|NCT00098774|Between October 2004 and November 2009, 47 participants were recruited at 12 CALGB sites.|Three participants were excluded from analysis because of failure to meet eligibility criteria or to receive protocol therapy.
758921|NCT00098748||
758922|NCT00098722||
758923|NCT00098670|Between January 2005 and December 2006, 103 participants were recruited.|One participant was deemed ineligible and is excluded from all analyses per study design.
758924|NCT00098475|The study opened on October 26, 2004 and was closed on June 1, 2007 with a total accrual of 452 patients enrolled from 6 groups and 77 institutions.|
758925|NCT00098371||
758926|NCT00098345|First patient enrolled 12 November 2004, last patient enrolled 15 August 2006, cut off date 22 February 2008. 40 patients were enrolled in the study.|40 patients were enrolled/screened to the study but only 30 patients were entered treatment/randomized.
758927|NCT00098306||
758928|NCT00098293||Data Safety Monitoring Board (DSMB) recommended termination of maraviroc once daily treatment after interim analysis at nominal week 16, 130 participants of 177 randomized were switched to open-label (OL) maraviroc twice daily.
758929|NCT00098254||
758930|NCT00098059||
758931|NCT00098020||
758932|NCT00097981||A total of 225 participants were randomnly assigned to treatment, 113 participants to the thal/dex group and 112 participants to the DOXIL/thal/dex group.
758933|NCT00097786|Initially enrolled 9518, 212 excluded.|
758934|NCT00097773|Recruitment was conducted from December 2004 to June 2009 from 55 Cystic Fibrosis Foundation accredited clinical centers throughout the US|
758935|NCT00097721|This study was recruited at 23 centers in U.S. during the period of Nov 2004 to Nov 2006.|
758936|NCT00097708||
758937|NCT00097695||Patients must have an eligible HAE attack to be randomized.64 patients were in the controlled phase(27icatibant,29 placebo,8subjects with laryngeal attacks were treated with open label icatibant).A total of 72 were treated in the open label phase(20 entered directly into the OLE phase+ 52 from the controlled phase).
758938|NCT00097669||
758939|NCT00097591|Acute Coronary Syndromes (ACS) includes subjects presenting with unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).|
758940|NCT00097539||All participants were assigned to a growth failure etiology group. Assignment was determined from etiology and medical history data and comments from all participant forms. Etiology groups were mutually exclusive. Participants with multiple etiologies were prioritized as follows: Turner, Renal, Other, Organic GHD, IGHD, ISS, and Undefined.
758941|NCT00097500||
758942|NCT00097448|Consecutive consenting adults with SSNHL from 16 academic medical centers around the United States.|All subject presenting within 14 days of SSNHL onset.
758943|NCT00097370|Participants (par.) who completed 9 months of treatment or withdrew from Study MHE100185 after receiving >=2 infusions of study medication were enrolled in this open label extension study. Par. with daily dose of prednisone >10 milligrams (mg) or <=10 mg at the end of Study MHE100185 were enrolled in Stage 1 or Stage 2 of this study, respectively.|This study was open-label extension to previous Study MHE100185 (NCT00086658). A total of seventy-eight participants participated in this study. Of these, 38 participants previously received placebo in Study MHE100185 and 40 participants previously received mepolizumab in Study MHE100185.
758944|NCT00097253|Participants were recruited through ads posted in the Columbus, Ohio area.|We excluded individuals taking cardiovascular medications or medications with obvious immunological or endocrinological consequences. Additional exclusion criteria included perfume allergies, smoking, problems with smell/taste, respiratory problems, asthma, excessive alcohol/caffeine use.
758945|NCT00096993||One subject in the placebo + gemcitabine arm did not receive any study treatment as the subject died of a cerebrovascular accident prior to the first scheduled dose. This subject was excluded from both the efficacy and safety analyses, per protocol.
758946|NCT00096954||
758947|NCT00096941||
758948|NCT00096785||132 enrolled; 63 not randomized (59 did not meet study criteria, 3 withdrew consent, 1 lost to follow-up). 1 randomized to adefovir (ADV) received entecavir (ETV) throughout treatment, & is counted in the ADV group for primary efficacy analysis, not included in the secondary efficacy analyses, & counted in the ETV group in safety analyses.
758949|NCT00096681||
758950|NCT00096538||
758951|NCT00096486||
758952|NCT00096460||
758953|NCT00096447|The study was activated on 11/1/2004 and closed to accrual on 9/26/2005.|
758954|NCT00096382||Of the 34 participants who were enrolled, 8 patients were not assigned to treatment since their TIL did not grow. Of the 26 assigned to treatment, 1 patient was not actually treated therefore only 25 patients were evaluable.
758960|NCT00096174|The study was open to accrual on 12/21/2004, and was closed on 07/20/2006. The final accrual was 69 patients.|
758969|NCT00095940|Participants from institutions in the Pediatric Brain Tumor Consortium were enrolled between November 2006 and October 2008.|Participants with tumors for whom surgical resection was indicated enrolled on the molecular biology phase and randomized to 1) receive lapatinib for 7-14 days pre-surgery or 2) no lapatinib pre-surgery. Those in group 2 who had measurable disease post-surgery would be included in the phase II part as well, but no participant met this criteria.
758970|NCT00095875|Between August 24, 2004 and December 29, 2008 145 patients were enrolled across 16 sites.|Patients were randomly assigned in a 1:1 ratio to recieve either induction chemotherapy with 3 cycles of TPF followed by concurrent chemoradiotherapy with either docetaxel or carboplatin or concurrent chemoradiotherapy alone with 2 cycles of bolus cisplatin.
758971|NCT00095836|Patients were enrolled from Massachusetts General Hospital and the Dana-Farber Cancer Institute|
758972|NCT00095784||
758973|NCT00095628||
758974|NCT00095576|"3000 participants were enrolled and randomized in the study. However, only 2979 received study vaccination, and are included in the started population.
~V520-023 was terminated early based on findings at a planned interim analysis and subjects were encouraged to participate in the V520-030 rollover study for additional long term follow up."|
758975|NCT00095563||1 enrolled patient was a screen failure.
758976|NCT00095498|First Subject Enrolled: 11-Aug-2004 Last Subject Enrolled: 07-Apr-2005|
758977|NCT00095303|Main Study: Adolescents who self-reported illicit drug use in the 30-days before baseline assessment or had to be referred from an institution for the treatment of drug abuse. Extended Follow Up Study: Participants from the Main Study who agreed to be contacted in the future, regardless of Main completion, were recruited to complete the assessment.|
758978|NCT00095238||
758979|NCT00095212|Recruitment began in August, 2004 and continued through October, 2006. Subjects were recruited via poster advertisement at community health centers, hospitals, and AIDS Service Organizations, as well as newspaper advertisement and provider referral.|Prior to randomization at the baseline visit, each subject's doctor was contacted to confirm safety of study enrollment. Subjects age 40 and older were required to have a mammogram performed within one year of study enrollment and provide results. Eligible subjects completed a pregnancy test at each visit and were excluded for a positive test.
758980|NCT00095199||Although 939 participants were initially randomized, 1 participant's data was inadvertently lost by a site prior to being entered into the database. As a result, we are reporting 938 as randomized.
758981|NCT00095173||214 enrolled; in Per A, 190 treated; 24 not treated due to screening failures.170 completed Per A, 123 responders qualified to enter Per B. One subject did not enter Per B; 122 responders were randomized, 60 abatacept and 62 placebo. 36 of 47 Per A non-responders re-entered at Per C. Protocol violation occurred; 5yr old participant.
758982|NCT00095147||748 participants enrolled in this study; 317 participants were not randomized or treated. 384 participants completed the double-blind period; 12 participants did not enter the open-label period.
758983|NCT00095121|First participant screened on 17 May 2004; first participant randomized on 21 June 2004. Participants from Gilead pharmacokinetics Study GS-02-517 were allowed to enroll regardless of screening serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) or alanine aminotransferase (ALT) concentration if they met all other entry criteria.|
758984|NCT00095056|"First Patient In: 14-Dec-04
~Last Patient Last Visit: 27-Jul-06
~75 study centers worldwide"|"Patients ≥18 years of age with chronic renal insufficiency and type 2 diabetes mellitus who had an A1C of 6.5-10% (not on baseline insulin therapy) or 7.5-10% (on baseline insulin therapy) after an antihyperglycemic agent (AHA) wash-off period of up to 12 weeks, were eligible to enter the 54-week
~study."
758985|NCT00094900||
758986|NCT00094887|Participants were recruited from 11 study centers in the United States|Of the 150 participants recruited, 150 were randomized (1:1) into treatment groups.
758987|NCT00094861|This study was conducted from 06 January 2005 until 20 December 2007 (last participant's last visit for the acute dysphagia evaluation phase). At the time of this report, the long-term safety follow-up period is ongoing.|100 patients were initially enrolled at 25 sites, however, data from one site could not be used and is excluded from this results analysis.
758988|NCT00094835|Participants were enrolled from 18 January 2005 through 25 September 2006|
758989|NCT00094809|Participants were enrolled from 12 February 2003 through 13 January 2006|
758990|NCT00094770|"Phase III
~First Patient In: 26-Oct-2004; Last Patient Last Visit: 17-May-2007; 173 medical clinics worldwide."|Participants 18-78 years of age with type 2 diabetes mellitus (T2DM) and inadequate glycemic control (Hemoglobin A1c >6.5% and < 10%) on metformin at a dose of >1500mg/day.
758991|NCT00094757|First Patient In: 15-Oct-2004. Last Patient Last Visit: 28-Apr-2006. 60 medical clinics in the United States (US), 37 in 4 countries in Europe, and 17 in 5 countries in the rest of the world.|Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (Hemoglobin A1C ≥7% and ≤10.0%) on diet and exercise alone were eligible to enter the study.
758992|NCT00094653||Of the 1783 participants who enrolled and were screened for study participation, a total of 676 subjects were randomized.
758993|NCT00094575||
758994|NCT00094536|Enrollment commenced 8/13/04, and was completed 1/20/06, with final 3-year follow-up occurring on 3/17/09. Assessments occurred at gynecologic offices. The majority of procedures occurred in the office setting, and the remainder in the ASC setting.|"Subjects were consented and assessed for inclusion/exclusion; qualified subjects underwent treatment and are considered the intent-to-treat group.
~Sample size was targeted for 76 subjects, however FDA granted the request for additional subjects to undergo treatment if consented at the time of completion of enrollment."
758995|NCT00094497||
758996|NCT00094458||
758997|NCT00094445|Recruitment Period: November 12, 2004 to November 11, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|1 participant did not receive treatment due to screen failure, patient withdrew the consent
758998|NCT00094328|The first patient was enrolled on 22 November 2004 and the last patient completed the 12 months visit on 7 May 2008. Patients were allocated treatment at 9 centres in 3 countries: India, the UK and the USA. Care for two patients, transferred from one US to a new approved US centre, therefore, patients were treated at 10 centres in total|Of the 24 patients enrolled, 10 failed eligibility criteria and were classed as screening failures while the remaining 14 patients were allocated treatment.
758999|NCT00094302|TOPCAT enrolled 3445 patients with heart failure and preserved ejection fraction at 233 academic and community medical centers in 6 countries between August 2006 and January 2012. Trial follow-up ended in June 2013.|Trial randomization was stratified by whether patients were enrolled into the study on the basis of having a hospitalization for heart failure within the past year (N=2,464) or having an elevated natriuretic peptide level within 60 days before randomization (N=981). The second criterion was considered only for those who did not meet the first.
759000|NCT00094211||896 participants were enrolled in the the study, but 34 dropped out after receiving the study materials and before completing the measures. Therefore, 862 participants provided data for this study.
759001|NCT00094172|Fourteen centers enrolled 83 participants and randomized 82 participants(one participant voluntarily withdrew prior to randomization) who had experienced clinically isolated syndrome and were at risk for developing Multiple Sclerosis (MS) (two or more lesions on Magnetic Resonance Image (MRI) scans) between February 14, 2005 and July 24, 2007.|At a screening visit, participants underwent procedures to establish that all inclusion criteria were met and none of the exclusion criteria were met. Participants then signed an informed consent form.
759002|NCT00094107||
759003|NCT00094094||
759004|NCT00094055||
759005|NCT00093964|First/Last subject in: 13 October 2004/28 October 2005. Data analysis cut-off: 21 October 2010|
759006|NCT00093847|73 outpatients with major depressive disorder who were partial- or non-responders to SSRI/SNRI therapy were enrolled in this trial conducted at Massachusetts General Hospital.|This was a randomzized (1:1) double-blind, placebo-controlled adjunct study of oral SAMe tosylate (target doses of 800mg PO BiD) to standard SSRI and SNRI antidepressants for patients with MDD.
759007|NCT00093808||
759008|NCT00093795||
759009|NCT00093782||
759010|NCT00093756||Fifty two (52) patients were accrued, out of which 4 were cancels. Twenty one (21) patients were accrued for phase I portion of the study. Twenty Seven (27) patients are accrued for phase II portion of the study. Twenty Seven (27) Phase II patients are evaluable for primary outcome measure.
759011|NCT00093496|Twenty-nine patients were enrolled between November 15, 2007 and October 29, 2009. Two participants were found to be ineligible and two participants had major protocol violations. Therefore, we summarize baseline characteristics and adverse events using all 29 patients, but report endpoint analyses using 25 participants.|Participants were divided into two groups according to their prior gemcitabine exposure. Cohort 1 participants had no prior exposure to gemcitabine. Cohort 2 was comprised of participants with prior exposure to gemcitabine as a single agent or had experienced disease progression while on gemcitabine therapy.
759012|NCT00093470|This study was activated on August 18, 2004, suspended between August 8, 2007 and February 6, 2008 for toxicity and safety evaluation, and closed on December 7, 2009 with a total of 144 patients accrued.|
759013|NCT00093379|The recruitment period: April 16, 2004 to May 12, 2009. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
759014|NCT00093145|Due to slow patient accrual, only 32 patients of the planned 50 patients were enrolled. Patients were enrolled between June 2004 and July 2007.|
759015|NCT00093041||
759016|NCT00093015|First Subject Enrolled: 25 Aug 2004 Last Subject Enrolled: 04 Dec 2007|
759017|NCT00092677|Phase III. Study Initiation Date (FPI) was 06-Jan-2003 and Study Completion Date (LPO) was 17-Apr-2008. Primary therapy period 02-Mar-2001 to 31-Mar-2008 includes start date of therapy from the Simvastatin in Aortic Stenosis (SAS) study. 173 study centers worldwide (Denmark, Finland, Germany, Great Britain, Ireland, Norway, and Sweden)|Included patients with asymptomatic aortic stenosis as assessed on echocardiography, not requiring lipid-lowering therapy, and without known coronary heart disease or diabetes mellitus. 4 week placebo/diet run-in period was followed by treatment period lasting until 4 years after the last patient was randomized.
759018|NCT00092547|1781 participants were randomized to receive qHPV or Placebo in the Base Study. At month 30, participants who received Placebo in the Base Study were eligible to receive qHPV, and formed the Extension Group. Participants were to be followed for safety and efficacy for up to 10 years.|
759019|NCT00092534|Female participants were randomized to receive quadrivalent human papillomavirus (qHPV) vaccine (GARDASIL™) or placebo in the Base Study (V501-015, NCT00092534), and were followed for 4 years. Participants who received placebo in the Base Study were eligible to receive the 3-dose qHPV vaccine series during the Base Study Extension (EXT).|"Participants who received 3 doses of qHPV vaccine either during the Base Study or Base Study EXT were eligible for enrollment in the Long-Term Follow-Up (LTFU) Study (V501-015-21).
~The 10-year-long registry-based LTFU was conducted at 4 National Registry Study Centers (NRSC) in Denmark, Iceland, Norway, and Sweden."
759020|NCT00092521|The study Protocol 013 (NCT00092521) (N =5759 total randomized) was comprised of two sub-studies: Protocol 011 (NCT00517309) (N=1877 total randomized) and Protocol 012 (NCT00092482) (N=3882 total randomized). Final safety data are presented in the results for Protocol 013 (NCT00092521): the final participant visit took place on 19 January 2009.|
759021|NCT00092495||
759022|NCT00092456|"The study was conducted at 10 sites in the United States from 09-May-2003 (first patient in) to 02-Jul-2004
~(last dose given).
~Last subject completed follow-up: 13-Aug-2004.
~All data corrections applied (Frozen File) date: 30-Sep-2004"|"Subjects with prior rotavirus disease, chronic diarrhea, and fever at time of immunization were excluded
~from the trial."
759023|NCT00092443|"The study was conducted at 30 sites - 27 in the United States, and 3 in Finland from 24-Sep-2002 (first
~patient in) to 11-Feb-2004 (last dose given).
~Last subject completed follow-up: 08-Jun-2004.
~All data corrections applied (Frozen File): 07-Sep-2004"|"Excluded from the trial before assignment to groups were patients with: history of congenital abdominal
~disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea,
~or failure to thrive."
759024|NCT00092417|"Participants were recruited at 18 sites in the United States, Canada, and Europe
~Prime Therapy Period: 30-Oct-2003 to 07-Jun-2004
~Cutoff date for in-house data: 24-Aug-2004"|
759025|NCT00092131|"Patients were randomized at 9 sites.
~Primary therapy period: July to November 2003"|Patients who required excluded medications, or did not meet forced expiratory volume in 1 second (FEV1) criteria during the prestudy period were excluded from randomization. Patients who required a β-agonist after the exercise challenge and did not meet FEV1 criteria within 30 minutes of treatment were also excluded.
759026|NCT00092118|"Patients were screened at 122 sites worldwide.
~Primary therapy period: Oct 2003 to May 2004"|Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime nasal symptoms score during the run-in period were excluded from randomization.
759027|NCT00091962||
759028|NCT00091949||
759029|NCT00091832|Participants were enrolled from 8 September 2004 through 9 May 2005|
759030|NCT00091819|Enrollment Period: 19 January 2005 to 12 June 2006|
759031|NCT00091793||
759032|NCT00091572||
759033|NCT00091507||
759034|NCT00091442|A total of 751 participants were enrolled and randomized at 143 sites in 19 countries.|751 participants were randomly assigned to 2 treatment groups (Docetaxel: 373 ; DOXIL+docetaxel: 378). 750 participants received treatment (Docetaxel: 373; DOXIL+docetaxel: 377). 1 participant in DOXIL+docetaxel treatment group did not receive treatment.
759035|NCT00091390||
759036|NCT00091273||
759037|NCT00091260||
759038|NCT00091169|This study was activated on 11/3/2005, suspended on 5/4/2006 after reaching its original accrual goal (160 eligible patients), reactivated on 9/6/2006 after the accrual target amendment (286 eligible patients) was approved, and closed on 1/23/2007 with a total accrual of 376 patients.|
759039|NCT00091026|Patients were enrolled at sixteen sites between September 2004 and February 2007.|
759040|NCT00090987|Date of Recruitment: August 4, 2005 to August 29, 2007 at 12 AMC clinical centers|Three patients withdrew from the study before receiving treatment.
759041|NCT00090870||
759042|NCT00090857|Patients enrolled from February 2002 through August 2007.|In this chemoprevention trial, postmenopausal women were screened and eligible based on serum estradiol levels. Of 405 women screened, 381 were eligible for blood draw. Of these 381 women eligible for blood draw, 87 were eligible for randomization based on serum estradiol level (>/=0.9 ng/dL). There were 38 women who declined to be randomized.
759043|NCT00090844|49 female patients were enrolled between July 2003 and January 2007.|
759044|NCT00090779|Participants were recruited across 27 study sites (25 in the US and 2 in Peru) in the AIDS Clinical Trials Group system between February 2005 and June 2009.|
759045|NCT00090766|A total of 63 participants were enrolled in this study conducted from 28 May 2004 to 13 May 2005. The study was conducted at 18 centers in 7 countries.|Participants were screened within 48 hours prior to transplant surgery (Day 1) and received valganciclovir from Day 1.
759046|NCT00090753|Participants were enrolled in one of the following Phase II or Phase III studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] or BA17284[NCT00081484]|
759047|NCT00090610|Between January 2004 and March 2007, 150 participants were enrolled at this multicenter study.|All patients were assigned
759048|NCT00090584|Between July, 2004 and January, 2006 4,043 women were screened for eligibility and 561 provided written consent. After further screening, 134 were found to be ineligible, 119 withdrew consent and 1 was excluded erroneously. The remaining 307 were randomized to one of the treatment arms.|Of the 134 found to be ineligible after consent, for 77 their urinary incontinence (UI) was not urge predominant, 19 had fewer than 7 episodes of incontinence per week and the other 38 were excluded for a variety of reasons.
759049|NCT00090519||
759050|NCT00090493|"All patients of the Myeloma Institute who have high-risk multiple myeloma because of abnormalities in their cytogenetics, could participate in this study at UAMS only. Final IRB approval was 6/14/04. The 1st participant was enrolled 4/4/05."|Pre-study: hemogram, blood chemistry, Helper/Suppressor Panel, Immunoknow count, serum protein electrophoresis and immunofixation , serum freelites, 24-hr urine (protein and immunofixation), quantitation of immunoglobulins, B2M, IL6, bone marrow aspiration and biopsy, MRI, bone marrow collection for gene-array.
759051|NCT00090363|447 patients with prostate cancer who had bone metastases with no pain or mild symptoms of pain and a rising serum Prostate Specific Antigen (PSA), despite a serum testosterone of <= 2.4 nmol/L (70 ng/dL), were recruited between 14th July 2004 and 10th January 2006.|135 of the 447 enrolled patients were not randomised to treatments groups: 126 failed screening and 9 did not meet one or more of the study inclusion or exclusion criteria.
759052|NCT00090545||
759053|NCT00090285||A total of 4164 participants were screened and 4065 were randomized
759054|NCT00090259|First patient in: Nov-2001. Last patient out: May-2009. 255 sites in 30 countries participated (Peru , Chile, Columbia, Mexico, Brazil, Belgium, Croatia, France, Germany, Greece, Holland, Italy, Norway, Poland, Russia, Slovenia, Spain, Turkey, UK, Egypt, Lebanon, Morocco, S. Africa, China, Hong Kong, Korea, Malaysia, Philippines, Singapore, Taiwan)|Patients who were on a Angiotensin II Antagonist (AIIA) had the option to begin losartan treatment with open-label losartan 12.5 mg for one week followed by losartan 25 mg for one week and were subsequently randomized to losartan 50 mg or losartan 150 mg.
759055|NCT00090233|Participants were recruited at 356 sites in Belgium, Costa Rica, Finland, Germany, Guatemala, Italy, Jamaica, Mexico, Puerto Rico, Sweden, Taiwan, and the United States from 12 Jan 2001 first patient in (FPI) to 06 Oct 2004 last patient in (LPI).|"Participants with: history of congenital abdominal disorders, intussusception, or abdominal surgery; history of
~known prior rotavirus disease, chronic diarrhea, or failure to thrive were excluded from the trial before
~assignment to groups."
759056|NCT00090220|Base Study Vaccination Period covers Day 1 to Month 7; Base Study Follow-up Period covers Month 7 up to approximately Month 48; Extension 1 (EXT1) Period covers approximately Month 60 to Month 67; Long-term Follow-up (LTFU, EXT2) covers approximately Month 72 up to Month 120|
759057|NCT00090402||
759058|NCT00090142|"Patients were randomized at 8 sites (7 in the US and 1 in Peru).
~Primary therapy period: May to October 2004."|"Patients who required excluded medications, or did not meet FEV1 criteria during the prestudy period were
~excluded from randomization. Patients who required a β-agonist after the exercise challenge and did not
~meet FEV1 criteria within 30 minutes of treatment were also excluded."
759059|NCT00090103||In a 4-week, single-blind placebo run-in period, all participants (par.) took two capsules consisting of one dutasteride-matched placebo capsule and one tamsulosin-matched placebo capsule once daily for 4 weeks. A safety follow-up was performed for all participants 16 weeks after the last dose of study drug.
759060|NCT00090051||
759062|NCT00089999|Participants (par.) with histologically confirmed invasive breast cancer with incurable stage IIIb, stage IIIc with T4 lesion, or stage IV disease at primary diagnosis or at relapse after curative-intent surgery and whose tumors overexpressed ErbB2 protein, documented by FISH were eligible for inclusion in this phase II study.|
759063|NCT00089986|The study was planned on 1845 participants, hospitalized with suspected or confirmed gram-negative severe sepsis, male or female >=18 years of age at 235 centers across 31 countries from 02 September 2004 to 25 June 2007.|A total of 1415 participant numbers were assigned during randomization process, five were duplicate randomization numbers and for other two, the participants did not provide informed consent, precluding them from enrollment. Out of 1408 participants, 29 did not receive study medication, remaining 1379 included in Intent-to-Treat (ITT) Population.
759064|NCT00089973|The study was conducted in females with advanced or metastatic breast cancer. The study was conducted from 30 January 2004 to 25 August 2006, with a total of 50 female participants enrolled in the study.|
759065|NCT00089895||Patients in both treatment groups who were undergoing PCI could receive unblinded eptifibatide provisionally immediately before or during percutaneous coronary intervention (PCI) at the discretion of the investigator.
759066|NCT00089843||
759067|NCT00089791|First Subject Enrolled: 03-Aug-2004 Last Subject Enrolled: 01-Jun-2005|
759068|NCT00089752|Participants were recruited from the sleep disorders clinic from each of the 5 participating centers. Potential participants were approached by study staff at each site once their medical record indicated that they may be candidates for the study. Recruitment commenced 1-11-05 and ended 4-18-2008.|
759069|NCT00089778||
759070|NCT00089674|First Subject Enrolled: 15-Apr-2004 Last Subject Enrolled: 29-Apr-2005|
759071|NCT00089661||
759072|NCT00089648||
759073|NCT00089635|Participants were enrolled from 11 August 2004 through 2 August 2006|
759074|NCT00089583|A total of 110 participants (par.) were enrolled in the study; however, 1 par. withdrew from the study prior to the first dose of study drug and was not included in the Intent-to-Treat Exposed or Safety Populations. Therefore, 109 par. received >=1 dose of study drug and are thus categorized as starting the study in the Participant Flow module.|
759075|NCT00089609||
759076|NCT00089544||
759077|NCT00089505|Study participants were recruited at 10 sites from 7 African countries: 3 from South Africa, 2 from Kenya, and 1 each in Botswana, Malawi, Uganda, Zambia and Zimbabwe, between November 2006 to July 2008. The Botswana site enrolled participants from two locations.|HIV-infected, treatment-naive women, at least 13 years of age with CD4+ count<200 cells/mm^3. Four participants were randomized but did not start treatment.
759078|NCT00089479||
759079|NCT00089414||
759080|NCT00089297|The study was activated on December 15, 2004 and was closed to accrual on February 6, 2006 after accruing 74 patients.|
759081|NCT00089284|The study was open to accrual between the dates of September 10, 2003 and October 31, 2007 with the first patient enrolled on study October 28, 2003. Patients were recruited from the outpatient Hematology-Oncology clinic at Northwestern Medical Faculty Foundation, and the in-patient Hematology-Oncology service of Northwestern Memorial Hospital.|For phase I, patients were allocated according to the amount of bone marrow involvement they expressed (either ≤ 5% or ≤ 6-24% involvement). Initially, patients were accrued to the first cohort of the ≤ 5% involvement group. After that group moved to the second cohort, patients in the ≤ 6-24% involvement group were enrolled to the first cohort.
759082|NCT00089141|Clinic patients were recruited from May 2004 through June 2008.|
759083|NCT00089128||
759084|NCT00089102||
759085|NCT00089076|"Participants were recruited from 2 medical clinics in the United States between August
~> 2004 and September 2007."|This was a phase I/II trial. A total of 18 participants were accrued, all to the phase I portion. This trial was terminated due to study design during the phase I; therefore, the phase II portion will never open. No results from the phase II portion are available.
759086|NCT00089024||
759087|NCT00089011||
759088|NCT00088985||56 patients enrolled; 23 were human leukocyte antigen (HLA:A2) negative, 11 withdrew/refused treatment prior to start, 4 consented/not treated due to study closure, 3 went to a different study, 2 died before treatment, 2 were human epidermal growth factor receptor 2 (HER-2/neu) not detectable, and 4 patients ineligible. 7 patients were evaluable.
759089|NCT00088972||
759090|NCT00088907|The study was activated on August 6,2004 and terminated on November 13,2008. A total of 270 patients (136 on arm I and 134 on arm II) was enrolled to first step of the study. In July 2007, registration to step 2 (single ZD1839 therapy) was suspended because other study indicated lack of good benefit/risk profile of single agent ZD1839.|
759091|NCT00088881||
759092|NCT00088829||
759093|NCT00088699||
759094|NCT00088634||
759095|NCT00088621||
759096|NCT00088595||
759097|NCT00088530|Patients were enrolled from 66 sites: 6 in the U.S, 4 in France, 3 in Bulgaria, 4 sites in Hungary, 3 in Ukraine, 11 in Italy, 2 in Romania, 3 in United Kingdom, 2 in Poland, 2 in Germany, 3 in Peru, 6 in Argentina, 1 in Colombia, 2 in Ecuador, 1 in Uruguay, 5 in Russia and 8 in India.|
759098|NCT00088465||
759099|NCT00088452|Enrollment occurred from July 2004 through October 2007|
759100|NCT00088413||
759101|NCT00088374|The accrual ceiling for this study is 25 patients. With an expected accrual of 10-12 patients per year, we expect to complete the accrual within 2-3 years.|
759102|NCT00088218|Recruitment Period 7/21/04 - 2/15/08; all patients were registered at The University of Texas M.D. Anderson Cancer Center.|
759103|NCT00088205||Participant flow reports those participants who discontinued from study drug. Only participants without confirmed progressive disease at the 30-day post-therapy visit were assessed for progression by radiological method every 3 months until disease progression.
759104|NCT00088166||
759132|NCT00086450|All trial-eligible patients must have multivessel disease suitable for either approach as determined by both an interventional cardiologist and a surgical investigator. The interventionalist and surgeon at each site will document their intentions of which vessels are targets for revascularization.|
759133|NCT00086346|Patients were recruited October 2002 to November 2006.|Patients were screened up to 30 days.
759105|NCT00088153|"Period of recruitment: 2003-2009. Location: Massachusetts General Hospital (Boston) and Hospital for Sick Children (Toronto).
~We screened 150 girls with anorexia nervosa (AN) (110 at MGH and 40 at SickKids) and 88 normal-weight controls 12-18 years. Following the screen, 110 AN and 40 controls were enrolled for the prospective study."|Reasons for enrolled participants being excluded from the trial before assignment to groups primarily included identification of exclusion criteria, loss of interest on the part of the participant, and loss to follow-up.
759106|NCT00087698||
759107|NCT00087685|Recruitment Period: June 18, 2004 to March 20, 2008. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.|
759108|NCT00087672|Recruitment Period: 7/8/04 to 2/27/09. All patients registered at the University of Texas MD Anderson Cancer Center.|The maximum accrual of 41 was met.
759109|NCT00087646|The study was conducted from 16 September 2003 to 27 February 2007. Participants were recruited over a total of 106 centers [(United States (37), Germany (19), Spain (10), France (9), Italy (7), Greece (5), Turkey (4), Belgium (3), Canada (3), Portugal (3), Sweden (3), Brazil (1), Switzerland (1), and UK (1)] in the study.|A total of 950 participants were randomized (318, 158, 158, and 316 in groups A, B, C, and D, respectively), 942 received the study medication. A total of 8 randomized participants did not receive study drug for various reasons which includes withdrew consent (5), violated the study entry criteria (1), and two had other protocol violations.
759110|NCT00087633|Patients were recruited from 24 study centers in the US over a period of 4 years (12-Oct-04 - 17-Oct-08)|Eligible for the study were male or female patients ≥18 years of age with HCV infection who underwent orthotopic liver transplantation (OLT) because of liver cirrhosis attributed to HCV infection
759111|NCT00087607|This study was conducted from January 2004 to April 2006 at 41 centers in the United States.|This study planned to enroll 344 participants (172 in each group). Of the total randomized 385 participants who met the eligibility criteria, five did not receive study treatment and were not included in any analysis population.
759112|NCT00087594|A total of 48 participants were screened at 6 study sites in the United States (U.S) between 20 November 2003 and 25 September 2006.|
759113|NCT00087568|This study was conducted from 29 Jan 2003 to 24 Mar 2006 across 14 centers in the United States.|A total of 80 participants (40 non-tolerators and 40 non-responders) were planned; however, 57 participants were enrolled only after receiving 12 weeks of PEG-Intron plus ribavirin therapy and received the study medication (25 non-tolerators and 32 non-responders).
759114|NCT00087555||
759115|NCT00087529||
759116|NCT00087516|First Patient In: 08-Jul-2004; Last Patient Last Visit: 07-Feb-2007; One hundred eleven medical clinics worldwide (56 in the United States and Puerto Rico, 16 in 6 countries in Europe and 39 in 11 countries in the rest of the world).|Patients 18-75 years not on an antihyperglycemic agent (AHA) or on oral single AHA or low-dose combination therapy were eligible to participate. Following a screening diet/exercise period of variable duration, patients with hemoglobin A1c (A1C) 7-10% were eligible to enter a 2-week placebo run-in/wash-off period prior to randomization.
759117|NCT00087490||
759118|NCT00087438||
759119|NCT00087152|The study was activated June 15, 2004. It was open to SWOG institutions who obtained Institutional Review Board (IRB) approval for this study. 27 patients were enrolled at 16 institutions. The study was temporarily closed to accrual April 19, 2005 to allow assessment of response in the first stage. It was closed permanently on December 15, 2005.|
759120|NCT00087139|The study was activated on September 16, 2004 and terminated on February 4, 2009 after reaching its accrual goal. A total of 124 patients were recruited from ECOG member institutions.|
759121|NCT00087126|This trial was opened to patient entry on January 3, 2005 and was closed to accrual on October 29, 2007.|
759122|NCT00087022||
759123|NCT00086996||
759124|NCT00086957||
759125|NCT00086684||Three hundred and sixty-nine patients enrolled in this study. One patient did not take any study drug. Therefore, only 368 patients were included in the primary analysis dataset.
759126|NCT00086619|Postmenopausal women with low bone density were recruited from 2004-2007 to participate in this study at a single academic medical center. Recruitment letters were sent to women in the Greater Boston area and the trial was also posted on clinicaltrials.gov.|Must satisfy inclusion and exclusion criteria.
759127|NCT00086580||Treatment was from initiation of study drug(s) to 4 weeks after last administration of study drug. Follow-up was for those without disease progression and ended upon disease progression or primary endpoint analysis whichever came first. Observation included those with disease progression who were observed for alternative rx and overall survival.
759128|NCT00086411|The sample consists of 260 self-referred lighter smokers to an urban university setting. The first participant was enrolled in February 2005, and the last follow-up was completed in March 2008. A total of 302 met confirmatory screening criteria, and 260 were enrolled.|An in-person confirmatory screening interview consisted of a medical examination, structured psychological interview (Mini International Neuropsychiatric Interview; Sheenan et al., 1997), and biochemical testing (i.e., carbon monoxide reading of expired air [CO], blood alcohol concentration,and urine drug test).
759129|NCT00086385|Subjects will be men and women, 50 years and older who smoke at least 10 cigarettes a day. They will respond to requests in the public media for individuals who are interested in quitting smoking, and will be referred from sources like UCSF Ambulatory Care Clinics, California Pacific General Medical Practice, and Jewish Family and Community Center.|One participant died at week 5 before randomization.
759130|NCT00086515|Primary therapy Period: 13-Jul-2004 through 02-Feb-2007 (for the 2-year Phase A and B periods); 100 study centers worldwide. (46 sites in the United States, 25 sites in 11 countries in Europe, and 29 sites in 13 countries in the rest of the world).|Patients 18-78 years of age with type 2 diabetes mellitus with inadequate glycemic control (hemoglobin A1C [A1C] ≥7% and ≤10%) on stable doses of metformin (≥1500 mg/day) were eligible to enter the 104-week study.
759131|NCT00086502|"First Patient In: 15-Jul-2004.
~Last Patient Last Visit: 28-Sep-2005
~71 study centers worldwide"|"Patients ≥18 years of age with type 2 diabetes mellitus and inadequate glycemic control [hemoglobin A1C
~(HbA1c) ≥7.0 and ≤10.0%] who were on a stable dose of pioglitazone (≥30 mg/day) after a variable
~screening period were eligible to enter the 24-week study."
759134|NCT00086281||
759135|NCT00086307||
759136|NCT00086190|SAD-PD enrolled 115 participants from 20 centers in the US, Canada, and Puerto Rico from June 2005 through March 2009. Participants were recruited from movement disorder clinics. Eligible participants included men and women 30 years and older who were diagnosed with idiopathic PD, without dementia and who met depression criteria.|
759137|NCT00086138|Participants were recruited from memory clinics at five academic centers in the United States.|
759138|NCT00086047|Patients diagnosed with juvenile fibromyalgia (ages 11-18 years)were recruited from four pediatric rheumatology clinics in the Midwestern United States.|Patients were screened to determine eligibility for the study. if they met eligibility criteria, they were enrolled in the study and immediately randomized to one of the treatment arms.
759139|NCT00085917|Recruitment period was over a period of 3 yrs from 2004 - 2007. Participants were recruited and screened through the OP8 clinic of the NIAID.|"There were no significant events or approaches following participant enrollment prior to group assignments.
~However if enrolled participants subsequently developed exclusion criteria such as active alcohol or drug abuse, they were excluded from the study."
759140|NCT00085839|The first patient was treated 17 March 2004 and the last patient completed 19 March 2007.|
759141|NCT00085735|Participants 3-21 years of age were recruited at Children's Oncology Group institutions worldwide and at sites affiliated with the Dutch Childhood Oncology Group. The first patient was enrolled on April 30, 2004 and the last patient was enrolled on January 6, 2014.|Patients were randomized to receive a smaller volume boost (radiation to tumor bed)(IFRT) or standard volume boost (radiation to the entire posterior fossa) (PFRT).Patients 3-7 years of age were also randomized to receive reduced-dose craniospinal radiation (LDCSI) or standard-dose craniospinal radiation (SDCSI).Patients 8 and older received SDCSI.
759142|NCT00085709||
759143|NCT00085644|Subjects diagnosed with active ankylosing spondylitis (AS) who have an inadequate response or intolerance to 1 or more nonsteroidal antiinflammatory drugs and who may have also failed 1 or more therapies with disease-modifying antirheumatic drugs.|Subjects were randomized 2:1 to receive either 40 mg adalimumab subcutaneous (sc) every other week (eow) or matched placebo for the 24-week double-blind placebo-controlled period of the study. After 12 weeks, subjects without a reduction of signs and symptoms in ankylosing spondylitis (ASAS 20) were considered for open-label adalimumab treatment.
759144|NCT00085631|Patients were recruited between 2003 and 2008 from seven different university hospitals and medical centers internationally. A total of 101 patients were enrolled from these institutions and randomized by institution, disease stage and age.|Participant flow includes patients who were enrolled and randomized into the study. A third group of patients (Unavailable) was added in this participant flow to account for patients who were randomized, but whose treatment assignment was not documented in the current data.
759145|NCT00085566||
759146|NCT00085540||
759147|NCT00085436|Eligible patients were 18 and older, had measurable disease and newly progressive metastatic or new metastatic disease, tumor tissue for vaccine preparation, and signed consent. Eighteen mRCC patients were enrolled between January 2004 and August 2006.|
759148|NCT00085423|recruitment was open from February 2004 to December 2008.|
759149|NCT00085410|Participants were recruited through physician referral at: Fox Chase Cancer Center. The trial was discontinued early due to no confirmed partial responses.|Twenty individuals were enrolled in this study over a four year period.
759150|NCT00085293|Participants were consented at the University of Texas (UT) MD Anderson Cancer Center between 8/20/2004 and 4/28/2008. The trial was closed to new patient entry on 8/15/2008.|
759151|NCT00085254|Study sponsored by CTEP and conducted by New Approaches to Brain Tumor Therapy (NABTT). Pts accrued between April 2005 and December 2007. Pts were accrued from 11 Cancer Centers nation wide, in an outpatient setting. All pts had undergone previous surgery and had diagnosis of glioblastoma|
759152|NCT00085202|416 participants were enrolled between 9/9/2003 and 3/7/2013.|Of the 416 participants enrolled, three were ineligible and taken off study.
759153|NCT00085098||
759154|NCT00084929|2600 asymptomatic, out-patients, 50 years or older and prescheduled for screening colonoscopy were recruited for CTC between February 2005 and December 2006.|Of the 2607 registration events, 7 were registration errors [duplicate registrations due to system errors] and were cancelled. Therefore, a total of 2600 unique participants were enrolled to the study.
759155|NCT00084864||
759156|NCT00084838|Enrollment Sep 2004 to Sep 2006 at 9 institutions.|
759157|NCT00084747||
759158|NCT00084682|A total of 14 patients were enrolled from one institution between June 2005 and October 2008|
759159|NCT00084617|This was a multi-center single treatment arm study involving four sites. Patients were recruited February 2004 through February 2007.|
759160|NCT00084487|Patients were recruited for Cleveland area medical hospitals between November 2004 and November 2007.|
759161|NCT00084409|The majority of patients were recruited between November 2002 and July 2008 from from pulmonary medicine clinics.|Patients were excluded from randomization according to the exclusion criteria which included prior history of cancer, significant comorbid disease or inability to undergo 2 bronchoscopies, hypoxemia with the required use of supplemental oxygen, use of inhaled steroids within 6 weeks of enrollment, and carcinoma in situ or invasive cancer on bronch.
759162|NCT00084383||
759163|NCT00084318||
759164|NCT00084266||
759165|NCT00084149||
759166|NCT00084136|Study participants were recruited at 43 sites from 9 countries: 28 in the US, 4 in India, 2 each in Brazil, Malawi, Peru and South Africa, and 1 each in Haiti, Thailand and Zimbabwe, between May 2005 to August 2007.|HIV-infected, treatment-naive men and women, at least 18 years of age with CD4+ count <300 cells/mm^3.
759167|NCT00084084||No patient was enrolled in Cohort 2 (ie, no treatment-naive patients were enrolled).
759168|NCT00083915||
759169|NCT00083889|A total of 101 medical centers took part in the study between 10 August 2004 and 19 September 2008.|Subjects were to be followed until survival data was mature (median duration of follow-up: 123 weeks).
759170|NCT00004146|Between March and October of 2000 55 patients(pts) were accrued from outpatient clinics throughout ABTC(Adult Brain Tumor Consortium) consortium clinics|pts had to have confirmed GBM (Glioblastoma) and be untreated except for biopsy or surgery and corticosteroids.
759171|NCT00083759|First patient entered 24 May 2004, study terminated 28 February 2005. A total of 299 patients were evaluable for safety and 273 patients for efficacy. Study conducted in Argentina, Australia, Canada, Czech Republic, Poland, Slovakia, and the United States.|Patients who met these criteria were randomized to natalizumab or placebo: aged 18-75 with a diagnosis of rheumatoid arthritis (RA) Functional Class 1-3 for ≥ 6 months, on a stable dose of methotrexate (MTX), having ≥ 10 painful/tender joints, and with elevated C-reactive protein. Stratification based on baseline number of painful/tender joints.
759172|NCT00083720|A total of 87 patients were enrolled between 22 Oct 2004 and 20 Aug 2007 at nine sites in the USA and four sites in Canada.|
759173|NCT00083616|Participants were enrolled from 1 March 2004 through 19 Jul 2006. Patient disposition is reported up until the data cut-off date of 22 December 2006. Completed study is defined as participants who either died on study or completed the safety follow-up visit (30 days after the last dose of panitumumab).|
759174|NCT00083551||
759175|NCT00083382||
759176|NCT00082888|Participants were recruited from 2 medical clinics in the United States between March 2004 to November 2008.|
759177|NCT00082810|A total of 33 patients were enrolled from 3 institutions between March 2004 and August 2006. Two patients were ineligible; one had a performance status of three and elevated liver function tests that exceeded inclusion criteria, whereas the other received prior chemotherapy for metatstatic disease.|
759178|NCT00082758||
759179|NCT00082641||One subject consented to the study voluntarily withdrew consent prior to assignment to an arm, thus only 23 subjects placed in the study arms and are included in the data analysis.
759180|NCT00083226|This study was activated on March 19, 2004 and terminated on February 12,2007 after meeting its accrual goal of 40 patients. The final accrual of the study was 42 patients, enrolled through 4 ECOG member institutions.|
759181|NCT00083174|Between February 11, 2004, and March 23, 2010, 4560 women were recruited in medical clinics.|Eligibility of women was first checked before the randomization to the trial.
759182|NCT00083122|Forty-five patients were enrolled between December 23, 2004 and February 25, 2010: 40 patients to Group 1 (platin resistant; 14 evaluable, 26 measurable) and 5 patients to Group 2 (platin sensitive; 1 evaluable, 4 measurable). Group 2 was closed on 03/10/2006 due to poor accrual.|"Participants who progressed or relapsed during or within 6 months of primary platinum-based therapy constituted Group 1 (Platin Resistant). Participants who relapsed > 6 months following completion of platinum-based therapy, and who had received only a single prior chemotherapy regimen constituted Group 2 (Platin Sensitive)."
759183|NCT00082628||
759184|NCT00082433||PLEASE NOTE: Completed=number of participants completing ≥18 cycles of treatment; not completed=number of subjects coming off study treatment prior to completing at least 18 cycles, with specified reasons for coming off study treatment. Participants continued to be followed for overall survival.
759185|NCT00082381||Two patients were lost to follow-up after receiving study drug, and it is not known if they took at least one dose of the drug. For purposes of data analysis, these patients were classified as untreated.
759186|NCT00082407||Four patients withdrew from the study prior to receiving study drug.
759187|NCT00082368||
759188|NCT00082355|Recruitment began in 2004 and was completed by 2009. All patients were treated at NIH Clinical Center.|2 patients who were incorrectly diagnosed with Deep Vein Thrombosis (DVT) were excluded from the protocol after a preliminary ultrasound exam at NIH indicated they did not have DVT.
759189|NCT00082342||
759190|NCT00082329||
759191|NCT00082173|Subjects with respiratory symptoms suggestive of TB were recruited from the HUCFF outpatient TB clinic as well as other local TB clinics.|Patients who did not meet enrollment criteria or who did not want to participate in the study were excluded.
759192|NCT00003726|One participant was enrolled to the trial and started on 10mg and increased to 20mg. However developed progression of disease and was removed from the trial.|Funding was pulled and therefore the trial was not completed.
759193|NCT00081939||
759194|NCT00082017||
759195|NCT00081861|Recruitment Period: April 2004 through November 2006. All participants recruited at U.T. M.D. Anderson Cancer Center.|
759196|NCT00003270||
759197|NCT00081770||Enrolled 4469 subjects; Randomized 3083; Treated 3070
759198|NCT00081731||
759199|NCT00081653|Patients were recruited from 31 centers over the period of 18 May 2004 to 28 November 2007.|Eligible for the study were patients having completed Study BM16549 (NCT00081653) and who had complied with the monthly regimen for 75 percent (%) or more.
759200|NCT00081497|Only those patients who successfully completed the AGAL-008-00 (NCT00074984) trial were eligible for participation in the AGAL02503 (NCT00081497) extension study.|
759201|NCT00081458|First subject was screened 25May2004 and last subject evaluations were completed on 06Jul2007.|Patients underwent stabilization period for parenteral nutrition prior to randomization
759202|NCT00081328|Participants were recruited from July 2004 to February 2009. Participants were recruited from the patient populations of pediatric endocrine clinics at the participating study clinical centers, including satellite clinics. Posters announced the study. Study staff approached youth and their families during medical visits.|Prior to randomization, eligible subjects entered a 2-6 month run-in period, with goals of weaning from non-study diabetes medications, tolerating metformin at 1000 mg bid but no less than 500 mg bid, attaining glycemic control on metformin alone, mastering standard diabetes education, and adhering to study medication and visit attendance.
759203|NCT00081289||
759204|NCT00081263||
759205|NCT00081159|Recruitment period: July 6, 2004 to July 5, 2007. Recruitment done in medical clinic settings.|One participant of 80 male participants withdrew consent after the screening procedures therefore was not randomized nor treated and is excluded from the trial.
759206|NCT00080938|Study Activated on 10/18/2005, terminated on 3/13/2007. Institutes include Mayo Clinic Rochester, Northwestern University, Wisconsin, University of, Stanford University, Lankenau Hospital,Toledo Community Hosp Onc Prog CCOP,Sanford Cancer Ctr-Oncology Clinic,Carle Cancer Center CCOP|
759207|NCT00080912||
759208|NCT00080899||
759209|NCT00080535||
759285|NCT00075504|A total of 35 patients were enrolled from 7 institutions between December 2003 and August 2007|A total of 2 patients did not receive treatment
759286|NCT00075478||
759210|NCT00080483|This study was initiated in December, 2004 and enrollment ended in September 2008. Forty nine subjects were screened; 14 were screen failures and 35 subjects were randomized. Four subjects were withdrawn and 31 subjects completed the study.|
759211|NCT00002525|This study was activated on August 20, 1993 and was terminated on May 19, 2000 before reaching its accrual goal due slow accrual. The final accrual for the study was 859 patients.|
759212|NCT00080470||Although enrollment numbers totaled 148 subjects, the total number of implanted subjects were used for the analysis. Total number of implanted subjects is 87.
759213|NCT00080301||
759214|NCT00080288|42 centers (37 in US, 5 in Canada). First patient enrolled: 2 April 2004/ Last patient last visit: 23 December 2004|9 participants (3 female ; 6 male) withdrew after randomization but prior to receiving study drug. These 9 patients are included in the Participant Flow table below.
759215|NCT00080223||Participants could enroll from Study PIPF-001 (a double-blind comparison of pirfenidone and prednisone in pulmonary fibrosis); individual-patient protocols (IPPs); investigator-sponsored Investigational New Drug applications (INDs) in idiopathic pulmonary fibrosis (IPF); and via an early access program (EAP) for participants with IPF.
759216|NCT00002540|Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).|Participants signed a study informed consent prior to being randomized to a study arm.
759217|NCT00080119|Study participants were recruited at four study sites, three in South Africa and one in Botswana, between December 13, 2004 and June 26, 2008|Infants perinatally exposed to HIV 91-120 days with documented receipt of Bacille Calmette-Guerin (BCG) vaccine by 30 days (>=90 days since receipt), no previous diagnosis or treatment of TB or contact with known TB case, stratified by HIV and randomized to receive blinded INH or INH placebo. 3 participants randomized but did not start treatment.
759218|NCT00079937||
759219|NCT00009737|A total of 1987 participants were recruited into the study across 164 centers in 25 countries. This study was conducted from 12 Nov 1998 to 01 Apr 2004.|
759220|NCT00079781|Subjects were recruited at Level 4 epilepsy centers, as categorized by the National Association of Epilepsy Centers (NAEC), through the United States.|In order to undergo initial implant, subjects were required to have successfully completed the non-significant risk Prospective Seizure Frequency (PSF) study, which gathered baseline characteristics and data including (pre-implant) seizure frequency. Subjects were required to maintain a minimum seizure frequency and remain on the same AED regimen.
759221|NCT00079677|36 centers in the United States, France, Germany, Russia, and Australia. First participant enrolled: 26 March 2004/ Last participant last visit: 23 October 2004|
759222|NCT00002601||
759223|NCT00079417||
759224|NCT00079391||
759225|NCT00079339|Participants from PBTC member institutions were enrolled on the phase I component between 01/30/2004 and 01/19/2006. The phase II component of the study opened on 06/02/2006 and completed accrual on 12/26/2007.|
759226|NCT00079326|Patients were recruited from February 2004 to May 2008 from Dana-Farber Cancer Institute/Partners Cancer Center and Memorial Sloane-Kettering Cancer Center|
759227|NCT00079274||
759228|NCT00079183||
759229|NCT00079040|Participants were recruited from ECOG member institutions between June 8, 2004 and August 18, 2006.|
759230|NCT00079001|Between January 2004 and May 2012, 645 participants were registered and randomized.|
759231|NCT00078949|619 patients in the first randomization. Only a selected subset of patient (N = 230) were randomized in period 2 of this study. Total sample size N = 849|
759232|NCT00078897|Participants were recruited through clinical centers in Arizona, Colorado, Texas, and New York following ambulatory colonoscopies. Eligible participants were between age 40 and 80 years and had undergone colonoscopic removal of one or more colorectal adenomas 3 mm or larger within six months prior to random assignment.|
759233|NCT00078819|This 48-week study was conducted at 42 sites in the United States and Canada. The first participant was enrolled on September 8, 2004, and the last participant on November 29, 2005.|On enrollment, participants underwent randomization at a 1:1 ratio by an interactive voice-response system.
759234|NCT00078806|Participants with systemic onset juvenile rheumatoid arthritis (SOJRA) were enrolled at 7 sites in the United States and 4 sites in Canada.|Participants who responded in Part 1A or 1B were randomized into Part 2, stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they received in Part 1. Participants entered Part 3 only if they had either flared in Part 2 or had completed 3 months of treatment in Part 2. Participants who did not respond in Part 1A or 1B were withdrawn.
759235|NCT00078767||
759236|NCT00078754||
759237|NCT00078728||
759238|NCT00078715|Patients with major depression were recruited to participate in the study at the Clinical Center on the main campus of the National Institutes of Health in Bethesda, Maryland. Recruiting began in 2004.|11 participants were run through a sleep deprivation procedure and 6 of those had a significant improvement in depression. These 6 sleep deprivation responders were randomized in the crossover yohimbine study.
759239|NCT00005947|Participants were randomized between January 2000 and September 2004 across 16 clinical trial sites.|Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
759240|NCT00078559|For this trial, one center in the United States enrolled ten eligible adult recipients of first kidney transplants (0-3 human leukocyte antigen (HLA)-antigen mismatch) from February 2005 to February 2006|At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form. Refer to inclusion and exclusion criteria section for more details
759241|NCT00002597||
759242|NCT00078377|47 centers in the US, Canada, France, Germany, Russia, and Australia. First patient enrolled (treatment): 23 March 2004/ Last patient last visit: 10 January 2005|2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up)
759243|NCT00078338||
759244|NCT00076687||
759287|NCT00075400|The study was activated on 1/5/2004 and closed to accrual on 8/1/2005.|
759288|NCT00075335||
759364|NCT00068770|pts were enrolled on this study from October 2003 to September 2004. Pts were enrolled in an outpatient clinical setting|pts were assigned to an arm at the time of enrollment
759365|NCT00068718||
759245|NCT00078403|People with hepatitis C virus (HCV)/HIV coinfection were recruited for participation in this study.|330 participants were to receive 12 weeks of PEG+RBV to determine EVR status. Of the 330, 33 discontinued prior to week 12; 113 were non-EVRs, 80 of whom were randomized between Arms A and B; and 184 achieved EVR, 170 of whom were eligible to continue. 169 of the 170 were assigned to Arm C and one was inadvertently randomized between Arms A and B.
759246|NCT00078325|37 centers in the US and Canada. First patient enrolled: 19 February 2004/ Last patient last visit: 6 November 2004|3 female patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)
759247|NCT00078312|41 centers (US 34, Russia 7). First patient enrolled: 30 January 2004/ Last patient last visit: 19 July 2006|5 male participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant). These 5 patients are in the participant flow, but not in the safety data set since they did not receive study drug.
759248|NCT00078286|Recruitment began in November, 2003 and concluded in March, 2008. Subjects were recruited from cardiology inpatient units as well as outpatient cardiology clinics.|
759249|NCT00077974||
759250|NCT00077857||
759251|NCT00077766|A total of 313 participants were randomized in this study conducted from 10 March 2004 to 31 August 2005 in 12 countries.|
759252|NCT00077922||
759253|NCT00077675|Enrollment Period: 20Feb2004 to 09SEP2004|
759254|NCT00077649|A total of 188 participants were enrolled in the study which was conducted at 23 centers in the United States from 13 January 2004 to 06 December 2005|Number of participants who completed and did not complete the 48 weeks of treatment are presented in the table .
759255|NCT00077636|The study was conducted in 8 countries from 20 November 2003 to 13 September 2005.|A total of 1400 participants were planned for the study; 1469 were randomized (736 were assigned to the 16-week treatment group and 733 were assigned to the 24-week treatment group) and 1465 received the study treatment.
759256|NCT00077623|A total of 817 participants were enrolled in this study conducted from 03 March 2004 to 23 September 2005 at 92 centers worldwide.|A total of 572 participants were randomized, of which 1 participant did not received the study drug.
759257|NCT00077610|A total of 673 participants were recruited at 91 centers in 8 countries with chronic renal anemia and dialysis therapy for at least 12 weeks before screening and during the screening/baseline period. This study was conducted between February 25, 2004 and August 17, 2005|
759258|NCT00077376|The study was activated on March 19th, 2004. Accrual was suspended on December 16th, 2004 after reaching the first stage accrual goal. After a pre-planned toxicity analysis, accrual resumed on March 4th, 2005. The study was completed on March 24th, 2006, after accruing 61 patients.|
759259|NCT00077207||
759260|NCT00077064||Patients were registered within 7 days prior to start of radiation therapy(RT) or during RT up to 48 hours prior completion of RT. They were randomized to captopril or observation within 48 hours prior to completion of RT. Eighty-one patients were registered, 48 did not continue to treatment assignment, 33 were randomized.
759261|NCT00076999||
759262|NCT00003222||13 participants were assigned to each arm in Stage I. 14 additional participants were assigned in Stage II to study arm 2. Data are reported for stage I. Reporting is planned for stage II when data are available.
759263|NCT00076804|The study site was a public sector ART clinic at the GF Jooste Hospital, a secondary level facility in Cape Town, Western Cape province of South Africa, serving several peri-urban townships. Enrollment began February 13, 2005, and ended on July 7, 2007, with the last follow-up occurring on July 25, 2008.|
759264|NCT00076752||
759265|NCT00076622||
759266|NCT00076570|Totally 31 patients were enrolled during August 2002 to October 2006 at NIH clinical center.|The enrolled patients were pretreated with Thymoglobulin and methylprednisolone induction followed by combination therapy with both sirolimus (Rapa) and tacrolimus (FK) for 6 months. At 6 months, those without rejection on protocol biopsy with good tolerance to both drugs were randomized either Rapa or FK monotherapy and followed up for 48 months.
759267|NCT00003298|E7296 was activated on February 25, 1999 and terminated on March 18, 2002 with a final accrual of 39 patients (accrual goal: 42 patients) enrolled by 13 ECOG affiliated institutions.|
759268|NCT00076336||232 patients randomized. One randomized patient in the telbivudine treatment group discontinued prior to commencing treatment and was excluded from the intent to treat (ITT) population. Three randomized patients (two in lamivudine group and one in telbivudine group) had no HBV DNA assessments after baseline and were excluded from ITT population.
759269|NCT00076258||
759270|NCT00076245||
759271|NCT00076219||
759272|NCT00076102|36 participants were enrolled in this study|
759273|NCT00076050||
759274|NCT00076024||Participants who progressed in Docetaxel + Placebo (Phase 2, Double-blind) after consent were eligible to continue to open-label phase. 16 participants crossed-over to open-label phase.
759275|NCT00076011||
759276|NCT00075946|The study was opened on Nov 21, 2003, and closed on Sept 12, 2008, with final accrual of 545 patients.|Patients received induction rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms, stratified on histology (follicular vs other), age, and time from diagnosis.
759277|NCT00075881|The study was activated on January 16, 2004 and terminated on March 7, 2005 after 44 patients had enrolled. Accrual rate was 3 patients per month, slower than expected rate (6 patients per month)|
759278|NCT00075829|Participants were enrolled between December 2003 and March 2007 from 37 different transplant centers.|
759279|NCT00075816||
759280|NCT00075803|Participants were enrolled from November 2003 through September 2006|
759281|NCT00075764|"707 Patients underwent randomization. 12 were excluded: 9 did not have metastatic disease, 1 had previous chemotherapy, 1 was estrogen-receptor and progesterone-receptor negative, 1 did not undergo chest imaging. In addition, 1 patient withdrew consent.
~694 patients were included in the analysis."|
759282|NCT00075725||
759283|NCT00075608|Participants were recruited from March 2003 through July 2008 through the transplant clinic and amyloid clinic.|
759284|NCT00075582||
759362|NCT00069160||
759289|NCT00075270||A total of 580 participants were enrolled and randomized to treatment; however one participant withdrew from the study before taking any medication. Thus, only 579 participants were included in the Intent-to-Treat Population (comprised of all randomized participants who had received at least one dose of randomized therapy [lapatinib or placebo]).
759290|NCT00075218|Enrollment began (medical clinic) in December 2003. Study was unblinded on 27 January 2005 (end of Double-blind treatment). Subjects experiencing disease progression could crossover to Open-label treatment. Open-label data collection ended May 2008.|"361 subjects randomized to double-blind treatment in 2:1 ratio (sunitinib vs. Placebo).
~255 subjects continued on or crossed over to Open-label treatment."
759291|NCT00075088|For 5-years, paramedics responding to 911 calls for symptoms suggestive of Acute Coronary Syndrome (ACS) in one U.S. county transmitted an electrocardiogram (ECG) to the target emergency department (ED) for all patients meeting eligibility criteria. A central computer received the transmission and randomized to an experimental or control group.|4,219 calls to 911 for ACS symptoms were made over the study period; 3,103 pre-hospital ECGs were transmitted by paramedics; 2,353 ECGs were successfully received by the target emergency department (ED); 794 patients consented. If patient consent was not obtained, data were not used.
759292|NCT00075023||
759293|NCT00074984|A total of 252 patients were screened for entry into the study and of these, 82 patients were eligible to be enrolled.|
759294|NCT00074958||
759295|NCT00074815||
759296|NCT00074802|Recruitment began in 2003 at the Adult Anxiety Clinic of Temple University and the Anxiety Disorders Clinic of the New York State Psychiatric Institute. 150 patients with Generalized Social Anxiety Disorder were enrolled in Phase I of the study (open treatment with the selective serotonin reuptake inhibitor paroxetine).|Among the 150 patients enrolled in Phase I, a total of 61 patients began Phase II These patients were classified as partial responders at week 12 (LSAS>29 but at least 10% improvement in LSAS score), and were therefore randomized to receive 16 weeks of continued treatment with paroxetine with or without CBT.
759297|NCT00074711||
759298|NCT00074581||
759299|NCT00074490||Enrollment was 442 (221 donors; 221 patients). 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
759300|NCT00074412|HIV-infected pregnant women were recruited from antenatal clinics at DAIDS Clinical Trials Sites in Zimbabwe, South Africa, Uganda & Tanzania between May 14, 2008 & January 20th 2010. 1700 mother/infant pairs were enrolled & infants were given daily doses of Nevirapine for 6 weeks at which point there were randomized to placebo or extended NVP.|Infants were excluded from randomization if in first 42 days: had a positive HIV-1 DNA PCR, breastfeeding was discontinued, never initiated or permanently discontinued open-label NVP, certain graded abnormal labs, skin rash grade2B or higher, clinical hepatitis, serious illness/condition that prevented compliance, or use of rifampin/ketoconazole.
759301|NCT00074308||
759302|NCT00074282|Patients were recruited from ECOG-ACRIN institutions between 12/16/04 and 5/6/13.|
759303|NCT00074269|The protocol recruited patients with Metastatic breast cancer for transplant after ATG, high-dose Melphalan and Fludarabine.This was a non-randomized, single arm pilot study. Patients received fludarabine IV days -8 to -4, ATG IV on days -7 to -4 and High dose Melphalan days -3 to -2. This protocol is closed to accrual as of March 2008|
759304|NCT00074165||
759305|NCT00074152||
759306|NCT00074035|Between December 2003 and March 2008, 39 participants were recruited to this study.|1 participant cancelled prior to receiving treatment and is excluded from all analyses.
759307|NCT00073983|Recruitment period began October 4, 2006 and was completed May 12, 2009. There were 11 SARC (Sarcoma Alliance for Research through Collaboration) sites participating. SARC sites are primarily academic institutions with Sarcoma programs.|
759308|NCT00073957||
759309|NCT00073918||
759310|NCT00073749||The study was conducted in 2 parts. Part 1: Dose escalation cohorts of inotuzumab ozogamicin to determine the maximum tolerated dose (MTD) included 21 days and 28 days dose administration cycles. Part 2: Expanded cohort using the MTD regimen identified in Part 1.
759311|NCT00073528||At the time of data cut off for this analysis there were still participants on study (ongoing). The maximum treatment period was up to 46 months at the time of the analyses of data presented in this results summary.
759312|NCT00073333||There were two studies contained in this grant. Study 1 was an assessment study and consisted of 379 participants - 200 normal controls and 179 participants with social phobia. Study 2 was a treatment study that consisted of 106 participants with social phobia. That is the study described below.
759313|NCT00073307|From randomization start on 01 Dec 2003 to 31 May 2005 [last subject randomized]. One subject randomized in Placebo did not receive treatment. This study was conducted at 120 centers from 19 countries.|Enrollment included outpatients with documented unresectable and/or metastatic RCC (Renal Cell Carcinoma), and subjects who had 1 prior systemic therapy for advanced disease on which the subject progressed, at least 1 unidimensional measurable lesion, intermediate or low Motzer risk score, life expectancy of 12 weeks.
759314|NCT00073073||
759315|NCT00073021|Recruitment began Feb. 28, 2001. Randomized 386 patients of which 117 had mild disease and 268 had moderate disease at baseline. Analysis only includes patients with moderate disease at baseline.|
759316|NCT00073008||
759317|NCT00072761|Recruitment began in December, 2004 and ended May, 2010. Among the 1074 children screened with a MRI of the brain, 1.9% (20 of 1074) had strokes and 35.2% (379 of 1074) had infarct-like lesions. 196 participants completed all pre-randomization procedures and were successfully randomly allocated.|
759318|NCT00072475|A total of 155 participants were enrolled between December 2003 and April 2008.|Of the 155 participants recruited, 2 participants cancelled prior to starting treatment; 7 were determined to have AML at registration and 4 had diagnosis other than MDS. Thus 142 participants were evaluable for response and 153 for adverse events.
759319|NCT00072449||
759320|NCT00072384||
759321|NCT00072293|Accrual began April 1, 2001 and closed February 28, 2010, after 934 patients from 27 centers in Europe, South America and Australia were randomized.|
759322|NCT00072280||
759323|NCT00072189||
759324|NCT00072176|Patients were recruited from 10 participating centers across Canada between May 2004 and June 2007.|
759325|NCT00071981|This study was activated on March 21, 2005, and terminated on January 12, 2009 with the final accrual of 175 patients.22 ECOG institutions participated in the study.|This study involved a pre-registration before randomization. For patients with locally-typed HLA status, randomization immediately followed pre-registration. For central evaluation of HLA status, samples were submitted after pre-registration, and results of the evaluation must have been received from the central laboratory prior to randomization
759326|NCT00072566||
759327|NCT00072514||
759328|NCT00071812||
759329|NCT00071799||738 patients screened from 98 investigator sites. Randomized patients contributed by 79 investigator sites.
759330|NCT00071890|From November 2003 to July 2006, 148 patients were randomized (81 in the IL-2 arm and 67 in the control arm in one centre of the NIH (USA) and 21 centres of the ANRS network (France).|31 patients were not included because : CD4 below 500 (n=8), patient decision (n=6), HIV RNA < 50 copies/ml (n=5), neutropenia or high bilirubin(n=3), CD4 nadir below 200 (n=2),other diseases (n=2), AIDS (n=1), other reason (n=4)
759331|NCT00071760|59 unique participants (par.) received >=1 investigational product (IP) dose; however, 1 par. was not given a randomization number and therefore was not enrolled into the study. Thus, the number of par. enrolled in the protocol record=58. 5/59 par. receiving only single doses of IP are not included in the Intent-to-Treat Exposed Population (N=54).|Per protocol, the initial intention was to enroll par. to receive fosamprenavir; however, ultimately, no par. were enrolled into cohorts to receive repeat dosing of fosamprenavir without ritonavir boosting. The 59 par. who received >=1 IP dose were included in the Safety Population.
759332|NCT00071721||
759333|NCT00071513|8th graders in 6 middle schools completed the screening battery; those with 15+ on the Moods and Feelings Questionnaire and below the clinical cutoff on the Youth Self Report, Aggressive subscale were eligible. 716 met criteria; 497 were randomized. 123 families or youth declined; the rest could not be contacted.|Participants recruited across 4 annual cohorts, included 241 youth randomized to HSTS and 256 to the Brief Intervention (BI). There were no significant differences between the 2 groups at baseline in terms of gender, race, and socioeconomic status (SES) as well as baseline comparisons of target variables (depression, hopelessness, anxiety, anger).
759334|NCT00071487||
759335|NCT00071396|Recruitment Period 10/21/02 - 3/27/09; all patients were registered at the University of Texas MD Anderson Cancer Center.|Of 48 patients enrolled, 41 patients were evaluable for response (2 patients withdrew before starting treatment and 2 were ineligible).
759336|NCT00071110|57 Participants were recruited from March 2004 - May 2007 at the UPMC Shadyside Center for Complementary Medicine.|Twenty-nine subjects were randomized to Sham and 28 to Electroacupuncture.
759337|NCT00071032||
759338|NCT00071006||
759339|NCT00070941|The recruitment dates 01NOV2006-31OCT2008 locations: James Godbold, PH.D. Mount Sinai School of Medicine Steven Ferrando, MD - Weill Medical College of Cornell University Teodoro Bottiglieri, Ph.D. - Baylor College of Medicine Dr. Peter Werner - Albert Einstein College of Medicine|
759340|NCT00071058||
759341|NCT00070707||
759342|NCT00003907|Participants were recruited from ECOG membership institution between August 6, 1999 and September 15, 2006.|
759343|NCT00070564||
759344|NCT00070499|Note that 403 patients were registered to the study. Three patients were registered to standard dose imatinib while concurrent randomization was occurring between standard dose imatinib, high dose imatinib, and dasatinib. Those three patients are included in both the standard dose imatinib A and B cohorts.|
759345|NCT00070317|This trial was opened to patient entry on June 21, 2004 and was closed to entry July 21, 2008.|
759346|NCT00070291|Participants were recruited from ECOG member institutions between September 2, 2005 and March 24, 2009. The study was terminated due to slow accrual.|
759347|NCT00070135|Between November 2004 and 2011, 121 participants were registered and received transplants at 21 centers.|Seven (7) participants were excluded from the all analyses after they were deemed ineligible.
759348|NCT00070109||
759349|NCT00070018||
759350|NCT00069953||
759351|NCT00069784|This study was conducted at 575 sites in 40 countries between August 22, 2003 and December 19, 2011. Three sites were closed and data from these sites were not analyzed following site audits and in compliance with rulings from national health authorities.|The purpose of the factorial design was to efficiently answer two independent scientifically worthwhile questions regarding insulin glargine and omega-3 fatty acids within the context of a single clinical trial. Sample size was determined based on the insulin glargine study objective. Results reported below are those of the insulin glargine study.
759352|NCT00069823|The planned enrollment was for 400 participants, 403 participants actually were enrolled and randomized in the trial. It is not uncommon for clinical trials not to exactly meet the sample size stated in the protocol.|
759353|NCT00069641||
759354|NCT00069576|19,665 pregnant women between 24 weeks 0 days and 30 weeks 6 days gestation with glucose levels greater than or equal to 135mg/dl and less than 200 mg/dl after a 1-hour 50-g glucose loading test were assessed for eligibility in the trial. 500 of the eligible patients consented for teh follow-up study.|Of the women screened, 7,381 consented to participate but 83 did not complete an oral glucose tolerance test. Of the 7,298 women who completed an oral glucose tolerance test, 54 were ineligible, 1,938 were referred for treatment and 4,348 had normal tolerance tests. Thus 958 with abnormal tolerance tests had mild GDM and were randomized.
759355|NCT00069277|This study was recruited at 2 centers in U.S.during the period of Aug 2003 to Apr 2005.|
759356|NCT00069264||
759357|NCT00069329||
759358|NCT00069238||
759359|NCT00069121||
759360|NCT00069108|The study was conducted from 09 Jul 2003 to 31 Aug 2006 at 87 centers in 19 countries.|
759361|NCT00069095|This study was conducted in 32 countries - Australia, Austria, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Mexico, New Zealand, Norway, Panama, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and USA.|A total of 2035 participants were randomized to any one of the treatment groups in the study (634 participants in the initial 2-arm part and 1401 participants in the 2x2 factorial part of the study), but only 2034 received study treatment as 1 participant was enrolled twice in the study at 2 study centers.
759366|NCT00068692|This study was activated on October 15, 2003. Accrual was suspended on November 26, 2004 and subsequently closed on October 25, 2005 with total accrual of 225 patients to step 1 and 179 patients to step 2.|
759367|NCT00068601||
759368|NCT00068588||1st 3 pts treated on arm 2. If 0/3 DLTs, escalate to arm 3. If 1/3 DLTs on arm 2, 3 more pts on arm 2. If 1/6 DLTs on arm 2, escalate to arm 3.If at most 1/6 DLTs on arm 3, MTD declared. If more than 1/6 DLTs on arm 3, then de-escalated to arm 2. If at most 1/6 DLTs on arm 2, MTD declared. If more than 1/6 DLTs on arm 2, then de-escalate to arm 1.
759369|NCT00068575|Recruitment Period: May 31, 2002 to January 14, 2010. All recruitment was done at UT MD Anderson Cancer Center.|Of the 29 participants who were enrolled, one patient dropped out prior to receiving study treatment.
759370|NCT00068445||
759371|NCT00068419||
759372|NCT00068406||
759373|NCT00068393|The study was activated on December 9, 2003 and was closed to accrual on April 19, 2007. A total of 39 patients were registered to the study.|
759374|NCT00068380||
759375|NCT00068367||Four patients enrolled to study were found to be ineligible. One patient did not have measurable disease, one patient had radiotherapy 19 days prior to registration and two patients were found ineligible upon pathology review.
759376|NCT00068341|Dates of recruitment period: 2002-2007 Types of location: oncology outpatient clinics|
759377|NCT00068250||
759378|NCT00068237||
759379|NCT00068107|13 participants were recruited; 1 participant was excluded because of stable kidney function; 12 started treatment|
759380|NCT00067990||
759381|NCT00067808|Recruitment Period 6/4/03 - 5/18/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.|Enrollment of 128 patients: 1 patient withdrew consent prior to treatment; 3 did not meet eligibility requirement for a total of 124 evaluable patients.
759382|NCT00067470|"Study Locations:Oakland, CA, USA Mainz, Germany Manchester, England Porto Alegre, Brazil Lyon, France Porto, Portugal
~Study Duration: 24 weeks
~First enrollment: 21 July 2003
~Last Dose Given: 1 April 2004
~Last Assessment: 8 April 2004"|
759383|NCT00067236||
759384|NCT00067028|Recruitment Period: December 2003 to October 2009. All participants were recruited at the University of Texas (UT) MD Anderson Cancer Center.|
759385|NCT00067002|Recruitment Period: April 10, 2003 to October 3, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.|Of the 110 participants registered, five were excluded prior to assignment to groups.
759386|NCT00066963|January 2001 - July 2002. Supplemental Nutrition Program for Women, Infants & Children (WICs); Womens resource center; medical clinics; pre-schools; dental clinics|Cleft lip or palate, developmental or learning disabilities, older than 36 mos; younger than 6 mos,immuno-compromised, born outside SF Bay Area where water is non-fluoridated, lack parental consent; lack 4 maxillary incisors, have caries, other family member in study, transient parents, ineligible to use SF Health Dept service
759387|NCT00066937||
759388|NCT00066807|Enrollment opened 4Aug03; the first patient was randomized on 1Jun04. The accrual goal for the study was 1750 patients. A total of 29 patients were randomized as of 31Dec06 when the trial was terminated. 25 of these 29 patients were also enrolled in the TEXT trial (IBCSG 25-02).|
759389|NCT00066781||
759390|NCT00066742|Between 9/2003 and 7/2006, 72 of planned 85 limited smal-cell lung cancer patients were enrolled by SWOG institutions. The study was closed early due to a report of excess toxicity for Tirapazamine in a head and neck cancer trial elsewhere.|
759391|NCT00066703|2672 patients were randomized between 7Nov03 and 7Apr11 at 182 centers in 15 countries.|
759392|NCT00066690|3066 patients were randomized between 17Dec03 and 27Jan11 at 426 centers in 25 countries.|
759393|NCT00066573||
759394|NCT00066469||
759395|NCT00066365||
759396|NCT00066222||
759397|NCT00066170||
759398|NCT00066066|Subjects with moderate to advanced chronic periodontitis were recruited to the clinical center at The Forsyth Institute. Subjects were recruited from the Boston area, subjects of any racial / ethnic group were accepted for study.|Only 5 subjects dropped prior to randomization due to conflicts in scheduling or unable to adhere to the monitoring plan.
759399|NCT00065806||
759400|NCT00014560||
759401|NCT00065611|8 patients were enrolled in the study, 4 of them are randomized to 2 dose every 2 week arm and 4 of them are randomized to 4 dose every 4 week arm.|
759402|NCT00065507||A total of 431 participants were enrolled into the study. 236 were never randomized (213 no longer met study criteria; 6 withdrew consent; 3 died; 1 for administrative reasons by sponsor; 1 for adverse events; 1 lost to follow-up; 11 for other reasons).
759403|NCT00065468||
759404|NCT00065442|Participants were randomized between August 2003 and November 2007 across 75 clinical trial sites.|Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
759405|NCT00065429|In Phase I, 32 patients were treated with doses ranging from 5 mg/m2/week to 75 mg/m2/week, with 9 patients treated at the MTD dose of 60 mg/m2/week. In Phase II, 32 advanced cancer patients were treated with BB-10901 at a dose of 60 mg/m2/week. (Total N=64)|This study was an open-label study. All patients that consented to the trial and met inclusion/exclusion criteria were enrolled.
759406|NCT00065260||
759407|NCT00065182|This was a multicenter study conducted at 62 centers: 11 in Canada, 5 in Poland, and 46 in the United States from 14 August 2003 to 30 August 2007. A total of 399 participants with advanced non-small cell lung cancer (NSCLC) were enrolled in the study and randomized to treatment.|Based on the interim analysis results, the independent data monitoring committee (IDMC) recommended termination of the combination group due to increased toxicity as well as a low likelihood of demonstrating an overall survival benefit at the final analysis.
759408|NCT00065156||
759409|NCT00065065|Patients were recruited from 15 clinical centers between September 6, 2002 and January 11, 2006.|
759410|NCT00003895||
759411|NCT00064987||Two subjects were deemed ineligible for the study. One subject was lost to follow up before being assigned to Group 1 or Group 2.
759412|NCT00064844|96 men and women were randomized to treatment at the Newington and West Haven campuses of the Veterans Affairs (VA) Connecticut Healthcare System.|
759413|NCT00064753|Trial enrolled 4110 participants from August 2002 through January 2007 at 20 clinical sites in the US, Canada, and Brazil.|
759414|NCT00003645||The study terminated early with low accrual with insufficient data for analysis.
759415|NCT00064792|23 subjects were consented and enrolled. 18 of 23 completed both arms of the study.|Each arm of the trial (placebo then simvastatin or simvastatin then placebo) was 12 months in length. The wash out period between phases was 2 months. Each subject served as own control.
759416|NCT00064701|De novo kidney transplant recipients 12 years of age and older were randomized in a 1:1:1 ratio to 1 of 3 treatment arms.|This study was a 1-year safety and efficacy study followed by a clinical continuation phase that continued until the sponsor discontinued the study in March 2009.
759417|NCT00064662|Between February 2002 and June 2004 at nine study sites, 2,405 women were screened: 556 were ineligible, 1,193 declined or withdrew consent and one died.|
759418|NCT00064350||
759419|NCT00064337||
759420|NCT00064298|Participants are recruited from NCI CCOP sites.|
759421|NCT00064259||
759422|NCT00064077|From May 2003 through April 2007, 513 patients were enrolled. Interim analysis recommended early closure for futility in January 2004.|Until January 2004, the study consisted of only two arms. Interim analysis recommended early closure for futility. 41 patients were enrolled until that point. These 41 patients were excluded from analysis. Two more arms were added and the study re-opened with 4 arms. The 472 patients enrolled after 1/26/2004 were included in analysis.
759423|NCT00064038|Between October 15, 2004 and April 2, 2007, 198 patients were enrolled at 41 cooperative medical institutions.|
759424|NCT00064025|The study was activated on 4/12/2004 and closed to accrual on 9/2/2008.|
759425|NCT00063999|GOG 0209 accrued 1381 patients from August 2003 to April 2009. 1312 of these patients were eligible.|
759426|NCT00063986|This study was activated on March 3, 2004 and closed on August 15, 2008. A total of 110 patients were accrued for this study.|
759427|NCT00063934|Recruitment Period: May 16, 2003 to August 25, 2005; All recruited at UT MD Anderson Cancer Center.|Of the 31 participants enrolled, one participant was ineligible for treatment.
759428|NCT00063882||
759429|NCT00063635|Between September 2005 and September 2007, 173 children were enrolled into TONIC at 10 clinical centers in the United States.|
759430|NCT00063622|PIVENS enrollment started in January 2005 and ended in January 2007.|A total of 339 patients were registered and screened for PIVENS trial, 92 of whom (27%) were found ineligible. The failure to meet histological entry criteria and fasting blood glucose >125 mg/dL were the most frequent reasons for ineligibility.
759431|NCT00063570||At completion of the first stage of the trial, toxicities associated with the Day 8 dosing of gemcitabine were observed, and the protocol was amended to a bi-weekly schedule. Patients were analyzed separately according to the study drug schedule received.
759432|NCT00063362|The study was conducted by the Mood Disorders Program at Case Western Reserve University/University Hospitals Case Medical Center (Cleveland, OH, USA) from August 2002 to June 2007.|
759433|NCT00063258|Recruitment Period: 10/13/2003 to 03/18/2008; All patients recruited at University of Texas M.D. Anderson Cancer Center|Study terminated due to low accrual; No evaluable patients were assigned to Chemotherapy Alone group (anticipated randomization to have been 10 of 40 patients treated with 3 courses of chemotherapy).
759434|NCT00063154||
759435|NCT00063232|28 adult patients with biopsy-proven NASH were enrolled in the study and 26 completed the 48 weeks of therapy and underwent follow-up metabolic testing, imaging and repeat liver biopsy. 2 patients dropped out were not included in analyses.|The two drop-outs included a 26-year-old woman who stopped therapy after 12 weeks because she had moved and her employment did not allow time for travel for outpatient visits and a 53-year-old woman who stopped therapy after 24 weeks because of desire to pursue other treatments.
759436|NCT00062868||
759437|NCT00062764|Between March 2001 and April 2002, 25 patients suspected of having NASH were evaluated, and 18 were enrolled in the study after screening.|
759438|NCT00062751||In the initial protocol, doses of CCI-779 were 25 mg daily and 75 mg intermittent; per protocol amendment, dosing was modified to 10 mg daily and 30 mg intermittent. All dose levels are included in the reporting groups.
759439|NCT00062738|Patients were recruited between 10/2003 and 7/2007, from the RWJMS movement disorder clinic and advertising to local support groups.|Patients who met inclusion and not exclusion criteria were enrolled.
759440|NCT00062647|Enrollment period: 14 Aug 2003 to 02 Aug 2006|
759441|NCT00062439||
759442|NCT00062374|Date Opened to Accrual: 6/5/2003 Date Closed to Accrual: 8/8/2006 Date Closed: 6/28/2011 Recruitment location is the medical clinic|
759443|NCT00062166||
759444|NCT00062010|Participants were recruited from ECOG member institutions between February 24, 2004 and August 22, 2007.|
759445|NCT00061945|From June 2003 to May 2007, a total of 302 participants were recruited.|Two (2) participants cancelled prior to receiving any treatment and were removed from all analyses.
759446|NCT00061932|A total of 41 patients were enrolled from 6 institutions between April 2003 and September 2006|
759447|NCT00061893||
759448|NCT00061633|Enrollment Period: 05Jun03 to 20Jan04|
759449|NCT00061373|Recruitment for this clinical trial opened in 2004 and closed in 2009. Patients who presented to one of two metropolitan Washington, DC hospitals with acute ischemic stroke and who treated with standard iv tPA were screened for study enrollment.|Enrollment into the MRI was preferential. If patients had contraindications to MRI or acquisition of MRI delayed treatment with iv tPA, they were enrolled in the non-MRI arm of the study.
759450|NCT00061048|Anticipate enrolling 10-12 patients per year into the Campath-1H trial. Thus, if the trial goes to completion (2nd stage)we anticipate enrolling the 29 patients in approximately 2.5 years.|
759451|NCT00060944|This study evaluated the efficacy and safety of of trabectedin in participants with locally advanced or metastatic L-sarcoma whose disease had relapsed or become refractory after treatment with an anthracycline and ifosfamide. The study was conducted between 12 May 2003 and 23 April 2008 and recruited participants from 9 countries worldwide.|In this study 271 participants were enrolled of which 270 participants (134 in the Trabectedin 1.5 mg/m2 group and 136 in the Trabectedin 0.58 mg/m2 group) were randomized as 1 participant was enrolled twice. Of these, 260 participants were treated with trabectedin including 130 participants in each treatment group.
759452|NCT00060840|There were 8 study medical centers that participated and enrolled subjects; 6 centers in the United States and 2 centers in Germany. There were 150 subjects enrolled in the study.|
759453|NCT00060606||
759454|NCT00060528|32 patients were accrued to the phase II portion of the study|
759455|NCT00060424||
759456|NCT00060346|The study was activated on June 15, 2004, and closed due to slow accrual on April 26, 2007. Sixteen patients were accrued in this trial from Eastern Cooperative Oncology Group (ECOG) and Southwest Oncology Group (SWOG) institutions.|
759457|NCT00060333||
759458|NCT00060008||
759459|NCT00059839|This is a multi-center, phase III, randomized trial for newly diagnosed children with advanced-stage anaplastic large cell lymphoma (ALCL). The study was activated on November 3, 2003 and the first date of enrollment was January 13, 2004.|Randomization occurs at the time of enrollment with all participants receiving Standard Induction of Doxorubicin, Prednisone and Vincristine (APO) and are evaluated at week 6 for continuation therapy.
759460|NCT00059787|A total of 56 patients were enrolled between June 2003 and December 2006.|
759461|NCT00059475|subjects were accrued to this trial.|
759462|NCT00059332||
759463|NCT00059215||
759464|NCT00059228||
759465|NCT00058825||
759466|NCT00058552||
759467|NCT00058539||
759468|NCT00058422||
759469|NCT00058370||
759470|NCT00058240|Patients with relapsed, symptomatic Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) were enrolled and received treatment between May 2003 and February 2006|
759471|NCT00058214||
759472|NCT00058188|PIs departure from the institution was sudden and due unforeseen serious circumstances. Due to this, no data was collected for this study nor can be reported on.|
759473|NCT00058123|55 patients enrolled between 7/14/2003 and 12/192005 at Outpatient Clinical Centers|
759474|NCT00058058|The data includes information on 1007 participants enrolled between April 1, 2003 and June 10, 2004 at 25 centers for data collected through August 8, 2006.|Patients were not imaged by MRI if they did not meet eligibility criteria, withdrew, or were otherwise unable to be scanned (claustrophobic, too large for scanner, illness, etc.)
759475|NCT00058019||One patient never received treatment and was excluded from analysis.
759476|NCT00057954|Participants were recruited from ECOG member institutions between June 1, 2005 and October 10, 2007.|
759477|NCT00057941|The study opened on September 16, 2003 and closed on May 29, 2007, with final accrual of 148 patients, 74 on each arm. Patients were accrued through ECOG group.|
759478|NCT00057876|The study was activated on April 10,2003, and terminated on December 15, 2005 as a result of slow accrual. The final accrual of the study was 74 patients. This was an intergroup study and coordinated by Eastern Cooperative Oncology Group with 9 participating groups.|
759479|NCT00057863|A total of 35 patients were enrolled in the study from April 2003 until August 2008.|
759480|NCT00057837|The study opened to accrual on March 24, 2004 and was closed on April 14, 2008 with final accrual of 140 patients.|
759481|NCT00057811||
759482|NCT00057785||
759483|NCT00057746||
759484|NCT00023673||
759485|NCT00057681|Recruitment was from media advertisements and clinical referrals from 2003 to 2008. There were a total of N=379 subjects randomized to 1 of the 3 group strata. The strata were (1) medication-naive strategy, (2) add-on strategy, and (3) cross-taper strategy. Analyses have only been conducted on the N=279 subjects in the first stratum.|
759486|NCT00057577|Recruitment into the study started in October 2002 and the last of the 452 patients randomized completed up to three years of treatment and a subsequent three your maintenance/follow-up in July 2012|
759487|NCT00057551||
759488|NCT00057330|8323 subjects were enrolled and vaccinated (4577 in the Herpes Simplex Virus Group and 3746 in the Havrix Group). Out of these, 7850 subjects were followed throughout the entire study, e. a. for safety and adverse event assessment (4488 in the Herpes Simplex Virus Group and 3662 in the Havrix Group).|
759489|NCT00056862|Between Dec 2003 and Dec 2004, 31 patients were enrolled into the low-dose group and were treated with peginterferon alfa-2a 90ug/week and ribavirin 400 mg/twice daily for 24 week. From Feb 2005, all subsequent patients were enrolled into a standard-dose group and treated for 24 weeks with the doses of the approved regimen.|
759490|NCT00056563|Patient recruitment begun in May 2002 and the discontinuation of randomization to the BMT arm was approved in August 2005 and participating sites received their IRB approval of this change through October 2005. A total of 255 patients were randomized to either BMT or DBS from 7 VA medical centers and 6 affiliated university sites.|An additional 23 patients were screened after signing the informed consent form but not randomized. 11 of them weren't willing to participate in the follow-up visits after intervention, 7 of them had neuropsychological dysfunction, 2 of them were not responsive to levodopa, and 3 had medical contraindication to surgery and/or DBS stimulation.
759491|NCT00056550|GTC Biotherapeutics (GTC) established clinical trials sites in hospitals located in the United States and Europe. GTC provided an international clinical team to support site registration requirements once a patient was identified for treatment. The clinical trial started in December 2002 and completed in February 2004.|Fourteen hereditary antithrombin (AT) deficient patients were enrolled into the trial. The patients included surgical (N = 5) and delivery patients (N = 9) who were treated with recombinant human antithrombin (rhAT) replacement therapy.
759492|NCT00056498|Though funding was in place beginning in 2001, recruitment took place from 2003 to 2008. Subjects were recruited from the Maryland Psychiatric Research Center Outpatient Reseach clinic, the Treatment Research Program, and community mental health centers.|86 Participants signed informed consent. 15 were ineligible or excluded. 71 Participants entered the evaluation phase. Two were withdrawn prior to randomization. Four people withdrew after randomization but prior to starting study medications.
759493|NCT00056472|Subjects were recruited from the inpatient and outpatient services of four academic sites between December of 2002 and June of 2007.|Antidepressant and antipsychotic medications being taken at entry were tapered and discontinued prior to randomization. Consented subjects were required to meet criteria for unipolar major depression and have at least one delusion. Subjects were also excluded if an unstable medical condition or evidence of recent substance abuse were present.
759494|NCT00056407||
759495|NCT00056316|Recruitment took place from 10/2001 to 3/2004. Project information was distributed to Alzheimers Association Chapters and Area Agencies on Aging (AAA's) in Midwestern USA (IO, IL,IN, KS, MI, MO, MN, NB,WI).|All enrolled participants who completed consent procedures were randomly assigned to groups.
759496|NCT00056160|"Subjects in the Placebo/Dex treatment group did not continue participation beyond the period Up To Unblinding (07 Jun 2005). Only subjects in the CC-5013/Dex treatment group participated in the period Extended Follow-up Cutoff (23 Jul 2008)."|"Only subjects in the CC-5013/Dex treatment group participated in the period Extended Follow-up Cutoff (23 Jul 2008). Data for the period Extended Follow-up Cutoff (23 Jul 2008) subsumes data for the period Up To Unblinding (07 Jun 2005)."
759497|NCT00055692|A total of 46 patients were enrolled between February 2003 and September 2006|
759498|NCT00055601||
759499|NCT00055497|276 participants were enrolled in the present study from 53 sites in the United States (US), Canada, Poland, Belgium, the Netherlands, and Czech Republic. The first visit in the present study for the first participant was 28 August 2002 and the final visit for the last participant occurred on 12 January 2005.|Study was rollover of NCT00055523; screening done in NCT00055523. At Week 4 of NCT00055497, 55 remitters at Week 0 and Week 4 of Study NCT00055497 were randomized to DB therapy; 204 non-remitters were assigned to OL adalimumab. 17 discontinued before/at Week 4, included in OL group for Participant Flow and AEs because they were not randomized.
759500|NCT00055471|22 male patients with metastatic prostate cancer and rising Prostate Specific Antigen (PSA) levels were recruited from 11th June 2003 (last subject completed on 31st October 2005). This study was conducted in 2 centres in the United States.|6 of the 22 screened patients were not entered into the study as they did not fulfill the study eligibility criteria.
759501|NCT00055237||
759502|NCT00054847|Multicenter, randomized controlled trial conducted from February 2003 to February 2009 at 11 Veterans Affairs medical centers among 757 participants (99% men) undergoing first-time elective coronary artery bypass graft surgery.|The left internal mammary artery was used to preferentially graft the left anterior descending coronary artery whenever possible; the best remaining recipient vessel was randomized to radial artery vs saphenous vein graft.
759503|NCT00054756||
759504|NCT00054717||In the study there were 630 patients entered as stated in the protocol section. There were 10 patients not treated and are not included within the Participant Flow Module or any other analysis.
759505|NCT00054704||
759506|NCT00054691|Recruitment period: July 2004 to September 2007. All participants recruited at The University of Texas MD Anderson Cancer Center.|
759507|NCT00054665||1 patient was deemed ineligible and did not receive any treatment. In addition, per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators (e.g. participants can skip A)
759508|NCT00054639|Recruitment Period: January 07, 2003 to October 01, 2005. Recruitment was done at UT MD Anderson Cancer Center Clinics.|Two participants enrolled but not assigned were not included in baseline measures. Of the total 48 participants enrolled, 42 were evaluable for response and 46 for toxicity.
759509|NCT00054353||
759510|NCT00054327|Thirty-five patients were recruited from local medical clinic from November 2000 through November 2009.One patient relapsed and never received a transplant.|
759511|NCT00054275|Patients recruited from University Hospitals and its satellite hospitals from 12/4/2002 through 9/22/2006.|
759512|NCT00054132||
759513|NCT00054028|Phase I trial was performed at Ohio State University(OSU). Phase II, OSU was the coordinating center with other participating centers.|Women with metastatic breast cancer
759514|NCT00053989||
759515|NCT00053898||
759516|NCT00053846||
759517|NCT00053703|From February 2002 to May 2006, youth were screened at four academic sites: University of North Carolina at Chapel Hill, McLean Hospital and Cambridge Health Alliance at Harvard Medical School, University of Washington, and Case Western Reserve University.|
759518|NCT00053677||83 participants began the placebo lead-in phase. 6 of those were placebo responders. The remaining 77 were randomized to Naltrexone or placebo.
759519|NCT00053495|Participants were enrolled from 10 January 2003 to 14 April 2003 in 4 medical centers in the US.|A total of 353 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
759520|NCT00053482|Participants were enrolled from 07 January 2003 to 31 March 2003 in 3 medical centers in the US.|A total of 357 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
759521|NCT00053417|Patients with clinically definite MS were recruited at clinics within the US and Canada|2-week placebo run-in
759522|NCT00053365|Stage I of the study accrued patients from 6/2/2003 through 10/31/2005. Stage II of the study accrued patients from 1/3/2006 through 4/7/2008.|
759523|NCT00053352||
759524|NCT00053014||
759525|NCT00003830||
759526|NCT00052962||
759527|NCT00052910||
759528|NCT00052715|Patients enrolled from 7/14/2003 through 12/19/2005. Patients recruited from outpatient clinic centers.|
759529|NCT00052429||
759530|NCT00049673||
759531|NCT00049543||
759532|NCT00049530|This study was activated on September 5, 2003, and patient accrual was terminated on June 15, 2011. A total of 32 patients were enrolled through ECOG member institutions. The study was suspended three times during the accrual period (February 2005, November 2006, January 2009) due to unavailability of ELISA kits to measure fibroblast growth factor.|This study involves a pre-registration and a registration. In the pre-registration phase, plasma samples must be submitted for determinations of b-FGF status by central analysis. Only patients determined to have an elevated b-FGF level (>15 pg/mL) by central review are eligible for registration.
759533|NCT00049517|From December 2002 through November 2008, a total of 657 patients were enrolled in the study.|
759534|NCT00049504||
759535|NCT00049322|date of recruitment period August 2003- October 2008. Types of location: Academic medical clinics and community medical clinics.|
759677|NCT00003472|Thirteen patients were recruited between May 1996 and August 2007. All study subjects were seen at the Burzynski Clinic in Houston TX|
759536|NCT00049257|Date of recruitment period: 10/02/2002- 5/25/2006. Types of location: Academic Medical clinics and community medical clinics. This study has 1 treatment arm; therefore randomization procedures were not utilized and all participants were enrolled to the same treatment regimen.|
759537|NCT00049127||
759538|NCT00049036||
759539|NCT00048997||
759540|NCT00047385|Recruitment was from August 2002 through April 2004 at 33 NLST sites.|Participants signed a study informed consent prior to being randomized to a study arm.
759541|NCT00047320||
759542|NCT00047060||
759543|NCT00047008||
759544|NCT00046930||
759545|NCT00046891|226 patients were enrolled to this study between October 2002 and October 2006. There were 14 cancellations and 2 ineligible patients removed from the analysis; these participants were randomized but withdrew before beginning any study interventions. Efficacy analyses use all patients that reported baseline and one value after baseline.|
759546|NCT00046839||
759547|NCT00045734|patients enrolled between June 2003 ad August 2005 in an outpatient clinic setting.|
759548|NCT00045708|Fifty-seven subjects were enrolled in the Phase 1 and Phase 2 between October 2002 and November 2005. Subjects were enrolled from outpatient medical clinics|Please note that 4 subjects in Arm B (non-P450- 6.8mg/m2) were used in the analysis and total n for the Phase 2. Hence, 19 new subjects were accrued to the Phase 2 portion of the study at the 6.8mg/m2 dose level, but the 4 subjects already treated at 6.8gmg/m2 were included in Phase 2 analysis.
759549|NCT00045630||
759550|NCT00045487|Open to accrual on 6/25/2002, closed to accrual on 4/22/2004 at The University of Texas Health Science Center at the Cancer and Therapy Research Center|
759551|NCT00045435||
759552|NCT00045305|This trial was open to accrual on May 18, 2005. By September 23, 2009, 17 patients were enrolled to the trial and the first 15 patients were included in the interim analysis. This trial did not meet pre-defined criteria to continue to the second stage. In the end, a total of 17 patients were enrolled to the trial from 7 participating institutions.|
759553|NCT00045162||
759554|NCT00045110|Subjects enrolled between August 15, 2002 and August 18, 2005. Patient recruited from outpatient oncology centers.|
759555|NCT00045032||After the release of initial study results, participants in the Observation Arm without disease recurrence were given the opportunity to cross over to receive 1 or 2 years of adjuvant Herceptin. Efficacy analyses were still performed according to original randomization.
759556|NCT00042991|Accrual to this study started with the first patient who enrolled on 07/01/2002 and ended with the last patient who enrolled on 05/31/2006. Nine institutions enrolled patients on the study.|There was no randomization to the three strata, which were distinct based on diagnosis and the use of enzyme inducing anti-convulsants (EIACD).
759557|NCT00042939|E8200 opened to accrual on 7/31/2003 and was suspended on 12/2/2004 for evaluation of response and toxicity. Arm B was reactivated on 7/12/2005 after meeting the response criteria; Arm A was reactivated on 11/23/2005. Arm B and Arm A closed to accrual on 4/17/2006 and 8/23/2006, respectively, after meeting the accrual goal.|
759558|NCT00041132||
759559|NCT00041119||
759560|NCT00041080|Enrollment began Feb 3, 2003 and completed Jan 30, 2011. All patients were enrolled from GOG member institutions in the United States.|Eligible patients had histologically confirmed ovarian, fallopian tube or primary peritoneal cancer. They had rising CA-125 that exceeded twice the upper-limit of normal, but no radiographic or physical evidence of disease following first-line chemotherapy.
759561|NCT00041067|During the period February 2003 to December 2006, 76 patients were enrolled at 28 SWOG institutions.|
759562|NCT00040937|Patients were recruited at participating cooperative group institutions.|
759563|NCT00040846||
759564|NCT00040742||
759565|NCT00039377|58 participants were recruited.|One participant was deemed ineligible and is excluded from all analyses per study design.
759566|NCT00039195||
759567|NCT00039130||
759568|NCT00036738||
759569|NCT00033657|E1201 opened to accrual on May 21, 2002 and accrued its first patient on August 15, 2002. A total of 97 patients were accrued from 19 different participating sites.|
759570|NCT00033631||
759571|NCT00033540||
759572|NCT00033514||
759573|NCT00033371|Recruitment Period: December 13, 2001 to October 21, 2008. All recruitment done in medical clinics, with the trial conducted at the University of Texas MD Anderson Cancer, the Cleveland Clinic in Cleveland and St. Mark's Hospital in Harrow, UK.|Of the 205 participants with familial adenomatous polyposis (FAP) recruited, 112 were randomized. The study was closed due to slow recruitment with enrollment target almost met.
759574|NCT00033293||
759575|NCT00031694|A total of 19 patients were enrolled from 5 centers between March 2002 and October 2003.|
759576|NCT00031590|Subjects were enrolled at three participating institutions namely Childrens Hospital of Philadelphia, Stanford University and Emory University.|Thirty subjects signed consent. One subject was deemed ineligible due to positive cerebrospinal fluid (CSF) and second subject was declared ineligible due to delayed start of radiation therapy (RT). Remaining 28 subjects continued on study.
759577|NCT00030901||
759578|NCT00030823||
759579|NCT00030264|23 eligible subjects were enrolled at the Children's Hospital of Philadelphia and Texas Children's Hospital between March 2001 and June 2011|
759580|NCT00028769||
759581|NCT00028002||
759582|NCT00027846||
759583|NCT00027560|Protocol Open to Accrual 07/31/2001 Protocol Closed to Accrual 05/23/2006 Primary Completion Date 04/14/2009 Recruitment Location is medical clinic|Enrolled participants receive preparative cytoreduction prior to transplant.
759584|NCT00026494||
759585|NCT00026312||
759586|NCT00026221||
759587|NCT00026208||
759588|NCT00025662|Recruitment dates: 9/21/01 to 11/14/05 Location: Quaternary referral institute|2 enrolled patients were not transplanted: one, because of donor refusal and the other because she was transplanted elsewhere
759589|NCT00025506|The study was activated on 9/4/2001 and closed to accrual on 3/3/2008 (suspended from 6/30/2003 to 8/1/2005).|
759590|NCT00025259||
759591|NCT00025233|The study was activated on 4/29/2002 and closed to accrual on 11/6/2006 (suspended from 2/7/2005 to 10/30/2005).|Patients must have persistent or recurrent squamous cell carcinoma of the cervix with documented disease progression. Patients were required to have measurable disease at time of study entry. They were required to have had a prior cytotoxic regimen.
759592|NCT00025155||
759593|NCT00024258||
759594|NCT00024167|Recruitment Period: April 16, 2002 to October 20, 2010 from various hospitals and institutions representing the Community Clinical Oncology Program (CCOP).|Of the 265 participants enrolled - 127 were randomized to either the Sr-89 treatment arm or the no Sr-89 treatment arm and the rest (138 participants) did not qualify for randomization. Of the 138 participants, 5 did not receive any treatment and the rest received only induction treatment. Study was closed prematurely due to issues with accrual.
759595|NCT00024102|This was an intergroup study led by the CALGB. Between September 2001 and December 2006, 633 participants were recruited.|All participants recruited were randomized with equal probability to one of two treatment arms. Randomization was initially stratified by age and performance score. In 2006 tumoral HER2 status was added as a third stratification factor.
759596|NCT00023764|Protocol Open to Accrual 06/21/2001 Protocol Closed to Accrual 03/11/2008 Primary Completion Date 03/10/2009 Recruitment Location is the medical clinic|
759597|NCT00023712|Accrual was broken down into two cohorts. Cohort 1 enrolled 28 participants from 11/5/2001 through 1/6/2003. Cohort 2 enrolled 30 participants from 4/5/2004 through 9/6/2005.|
759598|NCT00022698|A total of 67 participants were enrolled in the study, which was conducted from 18 May 2001 to 9 December 2004 at 18 study centers in the United States.|Data for participants who completed 12 cycles of the study treatment is presented.
759599|NCT00022672||208 participants were randomized. 1 participant did not receive study drug. After the completion of the 24 month Main Phase or disease progression, participants in the anastrozole-alone treatment arm entered the Extension Phase where they received trastuzumab + anastrozole.
759600|NCT00022659|The study was activated on 4/29/2002 and closed to accrual on 8/25/2004 (suspended from 10/6/2003 to 12/1/2003).|
759601|NCT00022633|The purpose of the subset of patients who aged 60 years or younger was to serve as a younger reference group for the pharmacokinetic parameter estimation. Therefore, this younger cohort is not included in analyses of adverse event, efficacy, and feasibility assessment of patient-reported outcome measures.|
759602|NCT00022516|1086 patients were randomized between November 2000 and December 2012.|
759603|NCT00022490||
759604|NCT00021255|The study was conducted at 433 centers in 43 countries. A total of 3222 participants randomized between 05 April 2001 and 30 March 2004. Participants stratified according to institution, nodal status(negative, positive 1-3 nodes, positive 4 or more nodes) and hormonal receptor status (estrogen and/or progesterone receptor positive versus negative).|Participants were randomized in 1:1:1 ratio to receive adjuvant therapy with either AC→ T, AC→ TH or TCH. During the course of the study, some participants received treatment different from the arm in which they were randomized. The safety analyses was conducted as per the treatment received.
759605|NCT00021229|Participants from PBTC member institutions were enrolled on the phase I component between 09May2001 and 28MAY2004 (stratum I), 15AUG2003 (stratum IIA), and 15AUG2004 (stratum IIB). The phase II component of the study opened on 28MAY2004 and was terminated on 13APR2005 due to poor accrual.|The intent of the phase I part of the study was to estimate the maximum tolerated dose (MTD) independently in stratum I, in stratum IIA, and in stratum IIB. The estimated MTD from stratum I was the recommended dose for the phase II part. Phase I participants in stratum I who received study drug at the MTD contributed to the phase II objectives.
759606|NCT00020722||
759607|NCT00019747||
759608|NCT00019682||
759609|NCT00019604||
759610|NCT00017563||
759611|NCT00016913|Between May 15, 2001 and June 30, 2006, a total of 34 patients were enrolled in the study. All CALGB institutions, comprised of 29 major university medical centers and their affiliates, were approved to participate in this study, of which 10 CALGB sites enrolled patients.|Of these 34 patients, 4 patients did not have radiotherapy, 2 patients were ineligible, and 1 case had limited follow-up data after radiotherapy. Final analyses were performed on 27 patients.
759612|NCT00016354|Nineteen patients were enrolled between August 2001 and July 2004 at Johns Hopkins.|Patients were excluded if they had known brain metastases, active infections, chronic diarrhoea, malabsorption, peripheral neuropathy >grade 1 (NCI CTC v2), pregnancy, HIV infection, or serious concurrent medical conditions.
759613|NCT00015847||
759614|NCT00014495||
759615|NCT00014222||
759616|NCT00012298||Phase I is a series of three single-arm trials: Trial 1 will determine the Y2B8 MTD without growth factors, Trial 2 will test the regimen with G-CSF and IL-11 added to the treatment, and Trial 3 tests different levels of IL-11 in the regimen.
759617|NCT00012012||
759618|NCT00011986|Received began 1/29/2001 and ended 1/28/2003. This was an interventional trial involving patients enrolled from the United States (US), Canada, United Kingdom (UK), Italy, Australia, and New Zealand.|This study involved patients enrolled from two cooperative groups with the plan to combine data. 3882 patients were enrolled from one cooperative group and 430 from the other. This report includes those patients from both groups.
759619|NCT00010257|The study was activated on February 21, 2001. The thymoma stratum closed to accrual on March 27, 2007. The thymic carcinoma stratum closed to accrual on January 18, 2008.|
759620|NCT00009945||
759621|NCT00008385|The study was activated on 10/6/2000 and terminated early on 11/5/2009 due to futility analysis with a total accrual of 1772 patients to step 1. Of the 1772 patients, 1561 were randomized on step 2.|The study had a 4-week run-in period to select patients with good compliance with the protocol therapy, defined as consuming at least 75% of prescribed placebo tablets. These patients were then randomized.
759622|NCT00008138||Of 62 enrolled participants, 4 were deemed ineligible.
759623|NCT00006916||
759624|NCT00006903||
759625|NCT00006721||
759626|NCT00006478||
759678|NCT00003471|Seven patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX|
759679|NCT00003470|Twenty-seven patients were recruited between March 1996 and November 2007. All study subjects were seen at the Burzynski Clinic in Houston TX|
759627|NCT00006392|Men were randomized at 427 study sites in the US, Puerto Rico and Canada between August 22, 2001 and June 24, 2004.|Prior to randomization, there was a three month formal pre-randomization period with no placebo run-in capsules to give potential participants to decide if they would agree to stop disallowed over-the-counter supplements of selenium or vitamin E. By returning for randomization, they exhibited their willingness to adhere to the trial.
759628|NCT00006389|From October 2000 through March 2002, a total of 12 patients signed a consent form and were enrolled on this study: 2 from COH, 8 from USC and 2 from UCD. All patients received treatment.|
759629|NCT00006244||
759630|NCT00006237||
759631|NCT00006227||
759632|NCT00006110|Participants were recruited from University of North Carolina (UNC) at Chapel Hill and Wake Forest University School of Medicine.|85 patients consented to treatment. 3 patients were consented but not treated.
759633|NCT00006101||
759634|NCT00006011|All patients were initially registered and initiated radiation treatment. Following succsessful completion of radiation treatment, participants with no evidence of disease received a random treatment allocation.|
759635|NCT00005957||
759636|NCT00005879|Screen by random periareolar fine needle aspiration for presence of hyperplasia or hyperplasia with atypia.|
759637|NCT00005803||
759638|NCT00005047||Patients with stage pT1/T2N0M0 urothelial cancer who had undergone a radical cystectomy within the prior 9 weeks were eligible for enrollment. Twenty-two patients who were registered were never assigned to a group after enrolling due to: missing baseline documentation (5), incorrect disease stage (13), and patient withdrawal (4).
759639|NCT00005044||
759640|NCT00004888|The study was activated on Oct 19, 2000 and closed on Sept 7, 2004. Accrual to Arm II was suspended on April 23, 2002 for a pre-planned interim analysis regarding cardiac safety and resumed on Nov 6, 2002. Study participants all came from ECOG institutions.|Entry on the study requires determination by the Eastern Cooperative Group Pathology Coordinating Office of HER2 expression status in primary breast tissue or site of metastasis. Patients with PS 2 were excluded from further enrollment in both arms as they were found to experience more severe toxicities and more frequent dose reductions.
759641|NCT00004859|The study was activated on January 27, 2000, and was terminated on October 26, 2006. 589 patients were enrolled to the study.|
759642|NCT00004259||
759643|NCT00004228||
759644|NCT00004143|The protocol was reopened in 2003 for non-malignant conditions only. Enrollment closed in 2008 due to lack of enrollment.|
759645|NCT00004124|983 patients consented and were enrolled to the trial. 22 patients were found to be ineligible per eligibility criteria, and were thus excluded from final analysis.|
759646|NCT00004092||
759647|NCT00004088||
759648|NCT00004054||
759649|NCT00003910|This study accrued 59 patients between July 16, 1999 and March 24, 2009. The study terminated with 59 patients on March 24, 2009 due to slower than expected accrual.|
759650|NCT00003901|One thousand-three hundred and ten participants were enrolled between July 1999 and March 2004. Data was analyzed in June 2009 when all eligible participants could have been observed for at least 5 years.|Two-hundred and sixty-three participants were ultimately removed from the study for various reasons (e.g. initially ineligible, final histology other than non-small-cell lung cancer), leaving 1047 participants evaluable for study endpoints.
759651|NCT00003896||
759652|NCT00003875||
759653|NCT00003869|Between April 1999 and January 2004, 194 patients were accrued to this study. This trial was closed to accrual prior to meeting the protocol projected 360 randomized patients due to slow accrual.|186 patients were randomized to either arm
759654|NCT00003820||
759655|NCT00003782||
759656|NCT00003702|This trial opened to patient accrual on 6/14/1999 and closed to accrual on 2/26/2007.|
759657|NCT00003659|Protocol Open to Accrual 09/08/1998 Protocol Closed to Accrual 06/14/2005 Primary Completion Date 05/12/2009 Recruitment Location is the medical clinic|
759658|NCT00003644|GOG 0175 accrued 571 patients from September 1998 to December 2006.|
759659|NCT00003641|The study was activated on December 22, 1998, and closed to accrual on October 26, 2010 with final accrual of 1150 patients|
759660|NCT00003631||
759661|NCT00003590|This study was activated on November 15, 1998 and closed to accrual on June 1, 2005. This was open to all SWOG institutions with IRB approval. Eastern Cooperative Oncology Group (ECOG) joined this trial on May 14, 2004.|All registered patients were to have eligibility assessed and sign informed consent prior to registration and receipt of protocol therapy.
759662|NCT00003537|Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX|
759663|NCT00003535|Nine patients were recruited between April 1994 and August 1997. All study subjects were seen at the Burzynski Clinic in Houston TX|
759664|NCT00003531||
759665|NCT00003526||
759666|NCT00003509||
759667|NCT00003499|Thirty-one patients were recruited between March 1996 and November 2002. All study subjects were seen at the Burzynski Clinic in Houston TX|
759668|NCT00003498||
759669|NCT00003492||
759670|NCT00003483|Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX|
759671|NCT00003479|Nine patients were recruited between July 1996 and October 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.|
759672|NCT00003477|Twelve patients were recruited between June1996 and May 2004. All study subjects were seen at the Burzynski Clinic in Houston TX|
759673|NCT00003476|Eight patients were recruited between March 1966 and November 2011. All study subjects were seen at the Burzynski Clinic in Houston TX|
759674|NCT00003475|Fourty patients were recruited between February 1996 and February 2011. All study subjects were seen at the Burzynski Clinic in Houston TX|
759675|NCT00003474|Forty patients were recruited between March 1996 and April 2003. All study subjects were seen at the Burzynski Clinic in Houston TX|
759676|NCT00003473|Twenty patients were recruited between March 1996 and May 2008. All study subjects were seen at the Burzynski Clinic in Houston TX|
759680|NCT00003469|Four patients were recruited between February 1996 and May 2003. All study subjects were seen at the Burzynski Clinic in Houston TX|
759681|NCT00003468|Eleven patients were recruited between July 1996 and November 2005. All study subjects were seen at the Burzynski Clinic in Houston TX|
759682|NCT00003460|Thirteen patients were recruited between April 1996 and January 2005. All study subjects were seen at the Burzynski Clinic in Houston TX|
759683|NCT00003459|Fourty patients were recruited between March 1996 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston, TX|
759684|NCT00003458|Thirty-four patients were recruited between September 1996 and July 2012. All study subjects were seen at the Burzynski Clinic in Houston TX|
759685|NCT00003457|Fourty patients were recruited between July 1996 and March 2011. All study subjects were seen at the Burzynski Clinic in Houston TX|
759686|NCT00003456|Forty patients were recruited between March 1995 and June 2004. All study subjects were seen at the Burzynski Clinic in Houston TX|
759687|NCT00003453|Six patients were recruited between August 1996 and February 2007. All study subjects were seen at the Burzynski Clinic in Houston, TX|
759688|NCT00003404|Patients were enrolled from a total of 30 different institutions. Half of the patients were treated at community-based treatment centers, and half were treated at academic medical centers.|
759689|NCT00003389|Between April 22, 1999 and June 15, 2006, 854 participants were enrolled.|
759690|NCT00003377|In Period I 12 patients were treated with weekly cisplatin(30-40 mg/m2) and paclitaxel(30-50 mg/m2) concurrent with extended field radiation. In Period II an additional 17 patients were treated with cisplatin 40 mg/m2 and paclitaxel 40 mg/m2 concurrent with radiation.|All patients received whole pelvic and extended field radiation at 150 centigray per day for 30 days to the para-aortics, and 180 centigray per day for 25 days to the pelvis.
759691|NCT00003199||
759692|NCT00003138|This study was activated on December 9, 1997 and closed on June 1, 2004. A total of 118 patients were enrolled (110 ECOG patients and 8 Canadian Leukemia Study Group [CLSG] patients).|
759693|NCT00002975|Study was activated in February, 1997, which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry was done by PI's staff. PI died and left incomplete data, and study was terminated in April, 2009.|
759694|NCT00002931||
759695|NCT00002874||
759696|NCT00002850||
759697|NCT00002842||
759698|NCT00002766||
759699|NCT00002651||
759700|NCT00002558||
759701|NCT00052078||
759702|NCT00051636||172 participants entered period 1; of these, 127 were identified as treatment responders and entered the extended observation period 2. Responders defined as patient who had ≥75% decrease from baseline in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint of normal range) or SAP within normal range at 6 months.
759703|NCT00051558||
759704|NCT00051363||
759705|NCT00051168|Patients were recruited in ophthalmic clinics, academic and civil hospitals from September 24, 2002. Last patient completed the study on March 23, 2009.|
759706|NCT00051025|This study was recruited at 6 centers in U.S. during the period of 18-May-2000 to 12-May-2001|
759707|NCT00050986|Total of 55 participants recruited in between 12/30/2002 and 11/30/2005, all at M. D. Anderson Cancer Center.|5 patients were not evaluated for response because of the following: 1 early, non-treatment related death; 3 withdrew consent; 1 discontinued for intercurrent illness (pneumonia).
759708|NCT00050960||
759709|NCT00050778|The study was conducted at 49 investigational sites in the United States, United Kingdom, and Eastern Europe between December 04, 2002 and January 12, 2010.|
759710|NCT00050622||
759711|NCT00050167|Recruitment period from November 20, 2002 to July 2, 2008. All recruitment done at UT MD Anderson Cancer Center.|Planned accrual was 930 participants, only 601 were found eligible.
759712|NCT00050089|A total of 368 participants were enrolled in the trial: 41 in Canada, 39 in the UK and 288 in the US-VA.|339 participants were randomized to factorial design(Canada=41;UK=10;US-VA=288). 29 participants in the UK were enrolled in a protocol-approved option, where they were allowed to select one of the factors and be randomized to the other. All 29 selected the ARDFP vs No ARDFP factor and were randomized to the Standard-ART vs Mega-ART factor.
759713|NCT00050011||Overall, 602 participants (301 in the upfront arm and 301 in the delayed-start arm) were randomized. Of these, 600 participants (300 in each arm) were treated. One participant in the upfront arm withdrew before taking any study drug and one participant in the delayed-start arm withdrew for administrative reasons prior to taking any study drug.
759714|NCT00049842||
759715|NCT00048932||1795 enrolled in study and 339 were not randomized due to no longer meeting study criteria (n=214), withdraw of consent (n=83), other reasons (n=32), participant was lost to follow-up (n=5), administrative reason by sponsor (n=2), adverse event (n=2), and poor/non-compliance (n=1). Of 1456 randomized, 15 were not treated.
759716|NCT00048815||
759717|NCT00048581||738 participants were enrolled and 393 participants were randomized. Two participants were randomized in error and were not treated.
759718|NCT00048568|Participants in this evaluation were enrolled 116 sites worldwide: 31 sites in the United States; 32 sites in Europe, 13 sites in Canada; 4 sites in Australia; 7 sites in Argentina; 7 sites in Brazil; 7 sites in Mexico; 3 sites in Peru; 5 sites in South Africa; 3 sites in Taiwan; and 4 sites in Turkey.|Of 1250 participants enrolled, 594 participants were not randomized (519 no longer met study criteria, 37 for unknown reasons, 33 withdrew consent, 3 lost to follow-up, 1 administrative reason by sponsor, and 1 adverse event). Four participants (2 per group) were randomized but never treated; 2 no longer met study criteria and 2 withdrew consent.
759719|NCT00048893||
759720|NCT00048737|Recruitment Period: October 30, 2002 to September 21, 2010. All participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.|
759721|NCT00048724||Analysis population is modified intent to treat (MITT), comprising 626 randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from analyses.
759722|NCT00048542|Subjects were enrolled at 31 sites between 19 September 2002 and 13 January 2005.|A total of 171 participants entered the Open-Label Lead-In (OL-LI) phase and received adalimumab. Of these 171 participants, 160 participants completed the OL-LI phase, and 133 participants entered the 32-week Double-Blind Phase (75 in the MTX stratum; 58 in the non-MTX stratum) and were randomized to adalimumab or placebo.
759723|NCT00048347||
759724|NCT00048165|The study was conducted across 31 centers in four countries from 28 Aug 1999 to 19 Aug 2002.|
759725|NCT00048074|A total of 1804 participants were screened for the study, from which 1395 participants were enrolled and randomized into treatment with ibandronate. The trial was conducted at 58 centers in 16 countries from June 2002 to May 2005.|Out of the 1395 participants who were randomized into the study, only 1382 participants received at least one dose of trial treatment and had at least one follow-up assessment as 4 participants did not have safety follow-up and 9 participants did not receive trial treatment.
759726|NCT00048061|The study was conducted from 26 April 2002 to 08 Dec 2004 across 65 centers in the world.|A total of 1609 participants were randomized, of which 1602 received the study drug.
759727|NCT00048048|The study was conducted across 15 centers in 5 countries from 07 March 2002 until 23 November 2004 (last date of extension Year 2)|
759728|NCT00048035|A total of 91 participants were enrolled in this study conducted from 19 March 2002 to 08 June 2005 at 14 Sites in United States.|
759729|NCT00047879|"We planned to accrue 32 patients to the GBM stratum and 32 patients to the AG stratum.
~The accrual ceiling was 64 patients on this trial. We anticipated accruing these patients within one year of opening this study."|
759730|NCT00047697||
759731|NCT00047619||
759732|NCT00047463|This pilot clinical trial was conducted between September 2002 and July 2005 at University of Michigan, Cleveland Clinic, University of North Carolina at Chapel Hill, and Vanderbilt University, with a Data Coordinating Center at the University of Michigan. 68 participants were enrolled and 35 were randomized.|Epilepsy clinic patients initially meeting trial eligibility on the basis of chart review completed a validated instrument that assesses the likelihood of having obstructive sleep apnea, and underwent a sleep and epilepsy evaluation by the site investigator. 68 patients consented, 33 not randomized due to not meeting criteria or declined.
759733|NCT00046475||Patients who completed the Titration Period were then randomized to receive either Midodrine/Placebo or Placebo/Midodrine during Treatment Periods 1 and 2. Some patients did not meet the criteria for randomization, had an AE, or withdrew from the study after completing the Titration Period prior to entering Treatment Period 1.
759734|NCT00046566||
759735|NCT00046228|The study was conducted in 20 countries. The FINESSE (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events) study began enrollment in August 2002. It was planned that approximately 3,000 subjects would be enrolled. Because of enrollment difficulty, subject enrollment was stopped on 30 Dec 2006.|A total of 2,461 subjects were enrolled in the study according to the sponsor's clinical trial management system. Out of 2461 subjects, 2,452 subjects were randomly assigned to the 3 treatment groups.
759736|NCT00045942|In PKC412A2104 (Core), FLT3 mutated participants with AML or MDS received open-label PKC412. In PKC412A2104E1, FLT3 mutated participants and FLT3 wild type participants were randomized to receive either PKC412 50 mg bid or PKC412 100 mg bid.|In PKC412A2104E2, participants were alternately assigned to the regimens, beginning with the first enrolled into the intra-patient dose escalation arm and the next enrolled into the PKC412 + itraconazole arm. Of the 16 participants enrolled in the PKC412 dose escalation arm, 14 were newly enrolled, and 2 were transitioned from PKC412A2104E1.
759737|NCT00044655||
759738|NCT00044512|Only subjects with measurable, histologically or cytologically documented hepatocellur carcinoma (HCC) which was inoperable or who had refused surgery could participate in this study.|Of 147 enrolled patients, 137 received treatment. 10 patients failed screening; reasons were: target lesions identified at baseline (3), liver function tests too high for inclusion (2), prior systemic anticancer treatment (2), creatinine too high for inclusion (1), platelets too low for inclusion (1), diagnosis of HCC not confirmed (1)
759739|NCT00044213|The primary analysis of the trial included 1708 patients who had been enrolled from September 2003 through October 2011 (median, 55 months)Participants were recruited at 134 sites in the US and Canada.|
759740|NCT00044044||
759741|NCT00044005||
759742|NCT00044083|Patients with schizophrenia were recruited through families, physicians and community organizations. Healthy volunteers were recruited through the NIH Normal Volunteers Office. Subjects first participated in Protocol # 95-M-0150 to obtain genotype data. If eligible after the study, they were invited to participate in the Tolcapone protocol.|
759743|NCT00043979||
759744|NCT00043550|374 individuals, ages 18 to 70 years, were recruited through advertisements on public transportation, free news publications, area physicians, and outpatient clinics during the period of 2001-2006.|Individuals not meeting MDD diagnostic criteria11 using the Structured Clinical Interviews for DSM-IV12 or scoring less than 14 on the 17-item Hamilton Rating Scale for Depression (HRSD)13,14 at two evaluations one week apart were excluded (n=88).
759745|NCT00043186|First Subject Enrolled: 11-May-2002 Last Subject Enrolled: 30-Apr-2003|
759746|NCT00042666||Participant Flow is reporting participants who discontinued from study drug. Per the protocol, a participant completed the study if the planned duration of treatment (6 cycles) was completed in the absence of disease progression or other reasons for discontinuation.
759747|NCT00042432|Participants were enrolled from 28 June 2002 through 14 November 2002|
759748|NCT00042224|participants were recruited from the inpatient units of the Zucker Hillside Hospital at Glen Oaks, N.Y., and the Pilgrim State Psychiatric Center in Long Island, N.Y.|In an 8-week random-assignment study incorporating nonblinded treatment and blinded assessments, patients with antipsychotic and clozapine-resistant schizophrenia were assigned to two treatment groups.
759749|NCT00041938|Recruited 2305 patients at 176 sites in 11 countries, between 10/1/2002 and 1/31/2010.|Intent-to-treat trial - all randomized patients followed and analyzed.
759750|NCT00041756||
759808|NCT00010374|This study enrolled patients who have suffered from high-level spinal cord injury, are full-time dependent on positive pressure mechanical ventilation and have intact bilateral phrenic nerves.|One participant had a false positive phrenic nerve test after consent
759751|NCT00041717|The target population consists of patients with chronic incomplete spinal cord injury (SCI) whose injury occurred at least 18 months prior to screening, and whose neurological status has been stable for at least 6 months.|One patient did not take any investigational drug and was excluded from the safety and ITT populations. The remaining 212 patients were included in the ITT and safety populations: 98 in the placebo and 114 in the Fampridine-SR 25 mg b.i.d. group.
759752|NCT00041470||
759753|NCT00040664|Cohorts were recruited in parallel. All Age Cohorts were given the same treatment.|"The overall study population consisted of 69 participants presented as Overall Fosamprenavir (FPV)/ritonavir (RTV) in the Participant Flow section. Furthermore, the Overall FPV/RTV participants are stratified by age cohorts (Arms 2-4)."
759754|NCT00041392|Hospital and preoperative clinic|
759755|NCT00040443||
759756|NCT00040365|This trial accrued 30 participants.|
759757|NCT00039871||Enrolled 2333; 21 subjects excluded due to Good Clinical Practice (GCP) non-compliance.
759758|NCT00039741|Recruited at Pediatric AIDS Clinical Trials Group (PACTG) units in the U.S. and Puerto Rico, and Paediatric European Network for Treatment of AIDS (PENTA) units in Argentina, Austria, the Bahamas, Brazil, France, Germany, Italy, Romania, Spain, the United Kingdom and Ireland. Enrollment started 9/25/02 and ended 9/7/05.|Participants were stratified by age (<3 years versus 3+ years), origin (PACTG site or PENTA site), and exposure versus no exposure to antiretroviral therapy perinatally. 266 children were randomized, of whom 3 are excluded from all analyses (2 had consent withdrawn by parents after randomization, 1 was ineligible).
759759|NCT00038948|Patients were recruited worldwide from January 2002 to September 2003.|Patients were screened for two weeks.
759760|NCT00038857|Recruitment Period:October 1, 2001 to November 1, 2008. All participants recruited at UT MD Anderson Cancer Center.|Of the 29 participants enrolled, one participant was excluded from the trial and did not receive any treatment.
759761|NCT00038727|All surviving Diabetes Prevention Program (DPP) participants with consent were invited to enroll into DPPOS throughout the follow-up period. The majority of DPPOS participants were enrolled in 2002-2003.|DPPOS covers 3 funding phases for the 3 study phases: DPPOS-1 (2002-2008), DPPOS-2 (2009-2014), DPPOS-3 (2015-2021). The groups are defined using the original randomized groups from DPP with recruitment period of 1996-1998.
759762|NCT00038649|Recruitment Period: June 11, 2001 to April 25, 2003. All recruitment done in medical settings at University of Texas (UT) MD Anderson Cancer Center.|Of the 117 participants enrolled, three were excluded before starting: two (2) withdrew from the study prior to initiation of treatment and one (1) was ineligible.
759763|NCT00038610|Recruitment Period: March 28, 2001 to October 04, 2006. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.|
759764|NCT00038467|The publication describing study results (Coombes RC et al; N Engl J Med 350; 1119) stated that 4742 participants were enrolled in study. It was later discovered that 2 participants were randomized twice. Hence, 4740 participants were enrolled in this study.|Main study also included 3 sub-studies only for the purpose of tolerability assessment: endometrial status, bone metabolism and quality of life (QoL). Out of 4740 enrolled participants, data for 16 participants from a center were excluded since it was considered unreliable. Results are reported for remaining 4724 participants.
759765|NCT00038142|Recruitment Period: November 13, 1997 to December 7, 2009. Recruitment was done within medical clinic settings.|Study closed early with low recruitment due to the sponsor going out of business therefore drug no longer manufactured.
759766|NCT00038103||2 subjects in the exemestane arm were never treated. One subject refused to be treated having originally consented to participate in this study and the other, reason for not starting treatment was unknown
759767|NCT00037830|Seventy-seven PD patients were recruited from all across the US for this single center, double-blind, delayed start trial of GM1. Seventeen subjects participated in the comparison group. Enrollment for the study began Nov 1999 and was completed in Jan 2006. Subjects were seen at the Parkinson's Disease Research Unit at Thomas Jefferson University.|
759768|NCT00036569||
759769|NCT00036270||
759770|NCT00035932||571 human immunodeficiency virus (HIV)-infected participants were enrolled; 358 (63%) were randomized to treatment. Of the 213 not randomized, 194 did not meet eligibility criteria; other reasons include duplicate enrollment (4), accrual closed (1), noncompliance (1), serious adverse event (2), patient request (11), missing information (4).
759771|NCT00035815|Subjects recruited from 20 medical centers from June 2003 to August 2005.|Patients were randomized and initiated on treatment at the time of enrollment.
759772|NCT00035555||A total of 230 participants who had undergone transplantation were enrolled
759773|NCT00033917|Preterm neonates of 600 - 1250 g birth weight were enrolled between 6 and 12 postnatal hours at Yale New Haven Hospital (New Haven, CT), Maine Medical Center (Portland, ME) and Women and Infants' Hospital (Providence, RI).|Cranial ultrasounds were performed on all study participants between 6 - 12 hours of age for group assignment. Subjects with major congenital cerebral malformations were excluded.
759774|NCT00032630|From February 2002 to May 2007, a total of 9663 patients who were scheduled for urgent or elective Coronary Artery Bypass Graft (CABG) were screened for enrollment. Of these, 7460 patients were excluded, mostly because of diffusely diseased or small coronary arteries. Overall,1099 patients were randomized to on-pump and 1104 randomized to off-pump|
759775|NCT00032591|Recruitment started in August 2003 and ended at the end of May 2006. Participating sites were VA Medical Centers with anticoagulation services with active rosters of more than 400 patients.|A total of 3745 participants were consented and screened. Out of this total, 823 were excluded from the study. The majority of those excluded is due to participants not doing or passing the competency assessment.
759776|NCT00032487|Twenty Veterans Affairs Medical Centers (VAMCs) were selected to participate in this cooperative study. The recruitment period was from 12/01/00 to 05/31/03.|A patient had to meet all the screening criteria for eligibility and had to sign a consent form with blood samples and meet all entry criteria for pre-randomization testing. Once the patient was deemed appropriate for the study, Hines completed the randomization assignment.
759777|NCT00031551||
759778|NCT00031486|Subjects enrolled in the study presented with findings of HSE.|Patients considered for enrollment are those who are receiving and will have completed IV Acyclovir for a minimum duration of 14 days to a maximum of 21 days at a minimum dose of 30 mg/kg/day to a maximum dose of 60 mg/kg/day.
759846|NCT00001586||
759779|NCT00031460|Neonates diagnosed with HSV-1 or HSV-2 <= 28 days of age with evidence of CNS HSV disease (with or without evidence of viral dissemination to other organs, such as the skin, liver, and lungs) then treated with intravenous acyclovir therapy. Subject has negative CSF PCR results within 48 hours prior to completion of intravenous acyclovir therapy.|Subjects enrolled while on 2 - 3 weeks of IV acyclovir therapy who have positive cerebrospinal Fluid (CSF) herpes simplex virus (HSV) PCR results within 48 hours prior to IV therapy completion, are not randomized.
759780|NCT00031447|Neonates diagnosed with HSV-1 or HSV-2 at least than or equal to 28 days of age as evidenced by infections limited to the skin, eye and mouth with normal CNS and treated with intravenous acyclovir therapy.|Participants enrolled while on 2 weeks of IV acyclovir therapy who have positive CSF HSV PCR results within 48 hours prior to IV therapy completion, are not randomized.
759781|NCT00030992|102 participants were enrolled in this study.|
759782|NCT00030147||Two participants signed the consent but were not started (did not meet inclusion criteria.)
759783|NCT00029536||
759784|NCT00029172|Subjects were recruited from 4 Indianapolis based hospitals. Depression enrollment and screening occurred between 1 and 2 months post stroke.|
759785|NCT00029146||
759786|NCT00029107|Between June 2002 and April 2010, a total of 24 patients were enrolled in the study. Twelve patients randomized to the rituximab group and 12 patients to the control group.|A total of 47 patients were screened for randomization into this study. Eighteen patients did not meet one or more of the above eligibility criteria. Five eligible patients elected not to enroll in the study because of concerns about potential rituximab toxicity. The remaining 24 patients were enrolled in the study and underwent randomization
759787|NCT00028262||
759788|NCT00028093||
759789|NCT00027378|This study was conducted at the Western Psychiatric Institute and Clinic (WPIC) of the University of Pittsburgh Medical Center (UPMC). Subjects were recruited for participation in the treatment study through referrals from any of the WPIC treatment programs and by responding to newspaper, radio and bus advertisements.|Exclusion: bipolar disorder, schizoaffective disorder, schizophrenia, hyper-or hypothyroidism, cardiac, neurological, renal impairment, significant liver disease, received antipsychotic or antidepressant medication, substance abuse or dependence, intravenous drug use, pregnancy, inability or unwillingness to use contraceptive methods, illiteracy.
759790|NCT00027027||
759791|NCT00026793||
759792|NCT00025883||
759793|NCT00023595|Pts were assigned to 1 of 3 strata before randomization. All pts in stratum C and some pts in stratum B were randomly assigned to med therapy + CABG or med therapy + CABG + SVR (Hypothesis 2 component of the trial-HO2). 76 of stratum B pts who were randomized to med therapy + CABG group belong to both H01 and H02.|Stratum A: eligible for med. therapy alone or med therapy + CABG; Stratum C: eligible for med therapy + CABG or med therapy + CABG + SVR; Stratum B: eligible for all 3 treatment options. All pts in stratum A and some of the pts in stratum B were randomized to either med therapy alone or med therapy + CABG (Hypothesis 1 of the STICH trial--H01).
759794|NCT00023452||The protocol design allowed enrollment of participants identified as members of the same household or group setting (such as group homes, settings) in clusters. The same treatment regimen to which a first participant was randomized could be assigned to other cluster members. All other participants enrolled were randomized individually.
759795|NCT00023322|Between October 2002 and June 2006, 13 patients were recruited into the study. The location is NIH clinical center.|
759796|NCT00023309|Forty-one patients were enrolled, twenty-two were randomized to receive the combination lamivudine and adefovir and nineteen to receive adefovir alone.|
759797|NCT00022763|Overall, 52 participants were enrolled in this study conducted at 16 centers in Spain and United States between 23 August 2001 and 09 December 2004.|
759798|NCT00016718||
759799|NCT00014911|Nine centers recruited participants 18 to 65 years of age who had Type 1 diabetes mellitus for more than five years, recurrent neuroglycopenia that included reduced awareness of their hypoglycemic episodes or severe glycemic lability, and fulfilled all eligibility criteria. Refer to the Eligibility section for more details.|
759800|NCT00006604|Date of First Enrollment: 16 November 2000; Date of Last Enrollment: 22 December 2009|
759801|NCT00004978|Patients were enrolled to ESPRIT between 2000 and 2003. As per the ESPRIT protocol, patients from previous Vanguard studies (in Thailand, Argentina, and the U.S., enrolled 1997-1999) were followed and included in the analysis cohort of this study if at least 90% of patients from that site consented to ESPRIT.|
759802|NCT00021541||
759803|NCT00018031|Patients were all recruited from other NIAID HIV clinical trials and from the nearby Maryland, Virginia and the District of Columbia HIV clinics|Open label study. The participants were only excluded if they did not meet eligibility criteria, such as pregnancy, availability to make frequent clinic visits and able to meet laboratory safety criteria as described in the clinical protocol.
759804|NCT00015457|Patients recruited from a medical clinic providing botulinum toxin treatment for cervical dystonia. Patients recruited between 6/21/01 and 10/19/06|Patients were excluded if response to previous btx injections were not stable, serious medical conditions, pregnancy, abnormal medical screening
759805|NCT00013611|1971 participants were randomized at 139 sites in 11 countries. The first randomization was on 30 April 1999 and the last randomization was on 28 September 2002. Sites who re-consented 2/3 or more of their participants to Version 3 of the protocol were included in the analysis cohort. There are 1695 participants in the analysis cohort.|
759806|NCT00010803|Recruitment occured between September 2000 through June 2002 primarily using mass mailings from targeted lists such as voter's registration and commercially available lists. Some sites chose to supplement this approach with newspaper, radio and television ads plus newsletter articles, posters and community presentations.|After mailing brochures to potential participants, we conducted a telephone screening followed by an in-person clinic visit to finalize eligibility. Randomization was done at a second visit within close proximity to the screening visit.
759807|NCT00010439|Dates of the recruitment period: 5/3/2001 to 7/23/2002. Types of location: Out-patient clinic, Clinical and Translational Research Center (CTRC, formerly General Clinical Research Center), Medical University of South Carolina.|
759809|NCT00007644|Enrollment begain in November 1994 and ended in January 2002 with follow-up through January 2010. We recruited men from 44 Department of Veterans Affairs sites and 8 National Cancer Institute sites.|A total of 13,022 men were entered into study logs as potentially eligible. Based upon further chart review, 6707 met age, comorbidity and prostate cancer specific criteria and received detailed information about the study. From these, 5023 were considered likely to be eligible and a total of 731 men agreed to participate.
759810|NCT00007475||Enrollment of subjects occurred at fraction of the anticipated rate despite over a decade of study conduct; the discrepancy between actual (15) and projected (100) enrollment is due to (a) lack of revising the registry entry with revisions of the protocol (n=50, excluding historical controls) and (b) lower referral rates by external nephrologists.
759811|NCT00007345||Although 7 cohorts were written in the protocol, the cohorts were consolidated for submission to the Food and Drug Administration (FDA) into the peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) groups, thus they are presented in this format.
759812|NCT00007020|A total of 85 patients were enrolled.|Of the patients diagnosed with a defect in bile acid synthesis during routine diagnostic procedures at the Cincinnati Children's Hospital Medical Center (CCHMC) Mass Spectrometry Laboratory, 85 patients were invited to participate in the study.
759813|NCT00006489||
759814|NCT00006411||
759815|NCT00006409||
759816|NCT00006400|200 patients planned; 233 patients screened; 197 patients eligible for study participation; 193 patients randomized to study treatment; 191 patients initiated study treatment|
759817|NCT00006305|A total of 2,368 patients were enrolled at 49 clinical centers from United States, Canada, Brazil, Mexico, Czech Republic, and Austria between January 1, 2001 and March 31, 2005. Each of the 2368 patients was simultaneously assigned to initial revascularization or medical therapy and assigned to insulin providing or insulin sensitizing therapy.|
759818|NCT00006289|Most patients are recruited by direct physician referral or through the Patient Recruitment and Public Liaison (PRPL) office. Potential subjects are determined to be qualified by screening at Clinical Center, NIH in the US.|Patients who have abnormal results from routine laboratory test or are positive for HIV are excluded. Women who are pregnant or positive for pregnancy test are excluded. Also patients who have non-traumatic pain disorders or are obviously have impaired mental capacity are excluded.
759819|NCT00006184||
759820|NCT00006178||
759821|NCT00006170|Women were recruited between September 1999 and October 2005.|Potential participants were excluded for current MDD, suicidality, drug or alcohol dependence within the past year, psychotic disorders, conditions associated with lowered seizure threshold, use of medications contraindicated with bupropion, uncontrolled hypertension, recent use of bupropion, pregnancy or use of other smoking or weight treatments.
759822|NCT00006156||
759823|NCT00006164||
759824|NCT00006151|Participants were recruited to a university based center for the study of addictions in 2002.|The study used a real world design meaning that participants were randomized on the same day as their study eligibility evaluation.
759825|NCT00005937||
759826|NCT00005908||
759827|NCT00005906||
759828|NCT00005901||
759829|NCT00005669|We recruited subjects from 2000 through 2008. Obese children (BMI 95th percentile or greater), aged 6-12y, were recruited through newspaper advertisements and letters to physicians, and were eligible if they had fasting hyperinsulinemia, (insulin at least 15mU/mL. Following an outpatient screen, participants were admitted for assessments.|Children were excluded if they had impaired fasting glucose or were diabetic, had significant renal, hepatic, cardiac or pulmonary disease, or presence of other endocrinologic disorders leading to obesity, had used prescription or non-prescription weight loss agents, or reported >2% body weight loss in the preceding 6 months.
759830|NCT00004980||
759831|NCT00004732||
759832|NCT00004635|With nine institutions participating (NCI intramural, Columbia in NY, LSU in New Orleans, Wayne State Univ., Univ. of Washington, Univ. of Minnesota, Univ. of Pittsburgh, Holy Cross and Portsmouth Naval Hosp.)it is expected that 16 pts per mo (190 per year) can be entered onto the trial with an estimated completion of accrual expected in 18 months.|While patients are crossed-over to the other therapy, because the time until crossover is dependent on time until progression, this differs from a classic crossover study in which patients are followed on both arms for a fixed period of time, evaluated, given a wash-out period, and then followed identically on the other agent.
759833|NCT00004563||
759834|NCT00004562|The primary analysis of the trial included 2166 patients who had been enrolled through December 2005 with an average follow-up of 2.9 years. An additional 35 patients were enrolled through June 2006 during an extended period of enrollment in the nuclear viability ancillary study. All 2201 patients are included here.|
759835|NCT00004547|A total accrual of 203 was expected within approximately 5-6 years (59 patients for adenocarcinoma of gastrointestinal origin, other than low grade mucinous; 48 patients with low grade mucinous adenocarcinoma; and 96 patients with primary peritoneal mesothelioma).|
759836|NCT00001984|Five patients aged 28-54 years scheduled to receive their first live-donor kidney transplant were enrolled after informed consent for study participation was obtained.|Patients were excluded if they were: HLA identical with their donor; on immunosuppression within 6 months of enrollment; or medically unsuitable for transplantation. Cytomegalovirus negative recipients of cytomegalovirus positive grafts were excluded.
759837|NCT00001962||
759838|NCT00001959|21 adults patients were enrolled between 2000-2004 at the clinical center of NIH|
759839|NCT00001941||
759840|NCT00000392||Of 457 persons screened for cognitive impairment, 205 men and 10 women were randomized (106 to peptide T and 109 to placebo).
759841|NCT00001832||
759842|NCT00001723|Accrual for RCT began in 1999 and ended in 2008. All subjects were screened at the NIH Clinical Center.|Most subjects screened but not enrolled (101) did not have an obesity-related comorbid condition (i.e., hypertension or dyslipidemia). 16 met a medical exclusion, and 13 declined participation after undergoing initial evaluation.
759843|NCT00001703|"Between 40-60 total patients may be required for this protocol.
~Between 2-3 years would be required to enter all necessary patients."|
759844|NCT00001656||
759845|NCT00001596|Patients were enrolled at the NIH Clinical Center between September 2005 to March 2009.|
759847|NCT00001575||All ph I pts who received an initial bone marrow transplantation received an initial dose of 10mCi followed by 15mCi. At the discretion of the PI on the basis of persistent reduced hematopoietic values, a subsequent dose may have been reduced from 15mCi to 10mCi or 5mCi. All ph II pts received at least one dose of 10mCi and/or 15mCi, or 20mCi.
759848|NCT00001566|42 patients were enrolled in this study.|
759849|NCT00001305||
759850|NCT00001304||
759851|NCT00001262||
759852|NCT00001213||
759853|NCT00001151||
759854|NCT00000378||
759855|NCT00000371|Subjects were adult outpatients recruited from three urban community health centers and two Veteran's Affairs medical centers in the greater Boston area. All eligible participants at these sites were invited to participate by their clinicians.|Sixty subjects met eligibility criteria and provided informed consent, but just 55 completed baseline assessments and were randomized to d-cycloserine or placebo.
759856|NCT00000620|All participants had established type 2 diabetes and were recruited from 77 clinical centers in the United States (64 sites) and Canada (13 sites). Recruitment occurred in two phases, from January to June 2001 and from February 2003 to October 2005.|Eligible participants provided evidence of ability to routinely monitor capillary blood sugars from written records or electronic downloads from a self-monitoring blood glucose device (SMBG), or (in cases where such records could not be provided) underwent a 2 to 4-week pre-randomization run-in period to evaluate compliance with SMBG monitoring.
759857|NCT00000575|Between December 1993 and September 1995, 1041 children from 5 through 12 years of age with mild to moderate asthma at eight clinical centers (two HMOs associated with academic or research institutions and six located in specialty practices within academic or research institutions) were enrolled.|Patients were required to stop all asthma medications except as needed albuterol (prednisone could be used for asthma exacerbations) at the close of the second screening visit. Also at this time, patients began keeping a daily diary of asthma signs and symptoms, medications, school absences, and physician contacts.
759858|NCT00000479||
759859|NCT00004500|Recruitment occurred between March 2000 and October 2002. Infants were enrolled from neonatal intensive care units and were randomized to open-label study treatment.|
759860|NCT00004445|Recruitment of participants is based on evaluation of past medical history and in person evaluation including strength, ROM, and response to stimulation to determine eligibility.|Participants will go through a screening process that will determine eligibility for the study. If they don't meet the inclusion or exclusion criteria they will not be invited to continue to the second phase of the study.
759861|NCT00004418|An open trial of Lorenzo's oil spanning decades (1998-2013). Centered at the Kennedy Krieger.|
759862|NCT00004412|Study began 1998, contacted physicians at several medical centers with patients under their care for SCD with refractory leg ulcers. Electronic materials describing the study and its sponsor were transmitted to medical centers.|
759863|NCT00000143|June 1997|
759864|NCT00000142|April 1994|
759865|NCT00000136||
759866|NCT00000135|Randomization was stratified on the basis of whether patients had untreated or relapsed retinitis. Primary drug therapy for CMV retinitis was determined by the treating physician.|Two hundred and nine patients with acquired immunodeficiency syndrome and active CMV retinitis were enrolled in a multicenter, phase 2/3, randomized, placebo controlled clinical trial. Patients received adjuvant treatment with MSL-109, 60mg intravenously every 2 weeks, or placebo,.
759867|NCT00000134|December 1992|
759868|NCT00000125||
