apoorvasrinivasan/scibert_finetune_rct_consort
Text Classification • 0.1B • Updated • 4
Unnamed: 0 int64 0 2.46k | PMCID stringlengths 10 10 | sentence_id stringlengths 3 4 | CONSORT_Item stringlengths 5 30 | labels stringlengths 54 54 | section stringlengths 6 61 | text stringlengths 7 1.12k |
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0 | PMC3002766 | S45 | ['3a'] | [0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study design | this double-blind, randomised, parallel-group, placebo-controlled study consisted of a ≤2-week screening period, a 24-week treatment period and an 8-week post-treatment follow-up period. |
1 | PMC3002766 | S46 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study design | the study was approved by local ethics committees and conducted in accordance with the amended declaration of helsinki. |
2 | PMC3002766 | S47 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study design | all patients gave written informed consent. |
3 | PMC3002766 | S49 | ['4b'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0] | Settings and participants | the study was conducted from october 2003 to may 2005 at 41 centres in europe and north america. |
4 | PMC3002766 | S50 | ['4a'] | [0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Settings and participants | recruited patients were ≥18 years old, with ssc as defined by the preliminary classification criteria of the american college of rheumatology (acr)17 and at least one active du (onset between 1 week and 3 months prior to randomisation) that was selected by the investigator and termed the ‘cardinal ulcer’ (painful area,... |
5 | PMC3002766 | S51 | ['4a'] | [0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Settings and participants | patients were excluded if they had received intravenous prostanoids within the previous 3 months, had used phosphodiesterase inhibitors other than for intermittent treatment of male erectile dysfunction, or had received inhaled or oral prostanoids or injected botulinum toxin in an affected finger within 1 month. |
6 | PMC3002766 | S52 | ['4a'] | [0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Settings and participants | patients were also excluded if they received systemic antibiotics to treat infected dus within 2 weeks prior to randomisation. |
7 | PMC3002766 | S53 | ['4a'] | [0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Settings and participants | also excluded were patients with body weight <40 kg, severe pah (who class iii/iv), moderate to severe hepatic impairment or serum aminotransferase levels >3 times the upper limit of the normal range (uln). |
8 | PMC3002766 | S54 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Settings and participants | contraceptive measures and monthly pregnancy testing were required during and for 3 months after the end of study treatment. |
9 | PMC3002766 | S56 | ['8a', '8b'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 1, 0] | Randomisation and interventions | after screening, patients were randomised to bosentan or placebo (1:1 ratio) by sequential allocation of randomisation numbers distributed to each centre in blocks of four. |
10 | PMC3002766 | S57 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Randomisation and interventions | patients received bosentan 62.5 mg twice daily for 4 weeks and then 125 mg twice daily for the remainder of the treatment period or matching placebo. |
11 | PMC3002766 | S58 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Randomisation and interventions | the dose could remain at or be decreased to the starting dose due to intolerance, with possible subsequent increase to the target dose. |
12 | PMC3002766 | S59 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Randomisation and interventions | concomitant use of systemic antibiotics, analgaesics and topical treatments for wound care were allowed, and randomised treatment was administered in addition to the usual, stable (over the previous month) treatment for raynaud's phenomenon. |
13 | PMC3002766 | S60 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Randomisation and interventions | patients who required parenteral, oral or inhaled prostanoid treatment during the study were first discontinued from study treatment. |
14 | PMC3002766 | S61 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Randomisation and interventions | use of glibenclamide, fluconazole, calcineurin inhibitors or ciclosporin a was not allowed due to potential drug interactions. |
15 | PMC3002766 | S63 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outcomes | the two primary end points were (1) the mean number of new dus per patient assessed by the investigator up to week 24 and (2) the time to healing of the cardinal ulcer up to week 24 in patients with cardinal ulcer healing maintained for 12 or more weeks. |
16 | PMC3002766 | S64 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outcomes | healing was defined as complete epithelialisation, regardless of residual pain. |
17 | PMC3002766 | S65 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outcomes | maintenance of cardinal ulcer healing required no recurrence at or contiguous to the original location at week 24 (if healing occurred before or at week 12) or during 12 weeks of observation with permissible extension of the treatment period (if healing occurred after week 12). |
18 | PMC3002766 | S66 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outcomes | to verify that the effect of treatment would not vary substantially across relevant baseline subgroups, the number of new dus up to week 24 was additionally analysed in subgroups based on predefined baseline factors associated with disease severity. |
19 | PMC3002766 | S67 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outcomes | secondary and exploratory end points included: (1) reduction of new dus and overall du number (proportions of patients with no new dus and with each number of new dus up to week 24, time to onset of each number of new dus up to week 24 and change from baseline to week 24 in total number of all dus), (2) healing (time t... |
20 | PMC3002766 | S68 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outcomes | post hoc analyses included: (1) the number of new dus up to week 12 in the overall patient population and in subgroups defined by randomisation month (october–february or autumn–winter and march–september or spring–summer) and (2) number of new dus, time to each successive new du and total number of dus through week 24... |
21 | PMC3002766 | S69 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Outcomes | patients were evaluated at randomisation/baseline and every 4 weeks during treatment (or premature withdrawal, week 24 and, if applicable, 12 weeks after healing of the cardinal ulcer), with dus assessed at each study visit. |
22 | PMC3002766 | S70 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Outcomes | safety was continually monitored. |
23 | PMC3002766 | S72 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | efficacy analyses were performed on all treated patients using sas software (sas institute, cary, north carolina, usa). |
24 | PMC3002766 | S73 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | means±ses are presented for numerical variables and kaplan–meier estimates for time-to-event variables. |
25 | PMC3002766 | S74 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | treatment effects for the primary end points were evaluated using the pitman permutation (new dus) and log-rank test with asymptotic approximation (time to healing of the cardinal ulcer). |
26 | PMC3002766 | S75 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | missing data on new dus were imputed using extrapolation, with the incidence rate of new dus at the last assessment corrected for the missing time period. |
27 | PMC3002766 | S76 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | the worst of either the calculated number or observed values at week 24 was used for patients who prematurely discontinued study treatment. |
28 | PMC3002766 | S77 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | patients with no valid assessment post baseline (three patients on bosentan, one on placebo) were excluded from the main analysis. |
29 | PMC3002766 | S78 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | treatment effects for new dus in predefined subgroups were presented as point estimates and 95% two-sided cis. |
30 | PMC3002766 | S79 | ['12a', '12b'] | [0, 0, 0, 0, 1, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | for exploratory purposes, statistical tests of treatment difference were provided for planned secondary/exploratory and unplanned post hoc efficacy analyses and included the pitman permutation (for changes from baseline), the fisher exact test (for proportions) and the log-rank test (for times to event), each performed... |
31 | PMC3002766 | S80 | ['12a', '12b'] | [0, 0, 0, 0, 1, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | placebo-corrected changes from baseline, rr and hrs from cox modelling were each reported with 95% cis where appropriate. |
32 | PMC3002766 | S81 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical methods | safety and baseline data were summarised descriptively, with no statistical testing planned or given. |
33 | PMC3002834 | S49 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study subjects | we studied a subgroup of crs patients from the epocares trial (clinicaltrials.gov, nct00356733), and healthy controls of comparable age and gender. |
34 | PMC3002834 | S50 | ['4a'] | [0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study subjects | a detailed description with inclusion and exclusion criteria of the study has previously been published.14 |
35 | PMC3002834 | S51 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study subjects | the protocol was approved by the medical ethics committee and all patients gave informed consent. |
36 | PMC3002834 | S52 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study subjects | procedures were in accordance with the helsinki declaration. |
37 | PMC3002834 | S53 | ['4a'] | [0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study subjects | patients with mild anaemia (women: 6.4–7.4 mmol/l; men: 6.4–7.8 mmol/l), moderate ckd (estimated creatinine clearance 20–70 ml/min, cockcroft–gault formula) and chf (functional nyha class ii–iv, based on symptoms, signs and objective abnormality on echocardiography,15 reduced ejection fraction (<50%) or left ventricula... |
38 | PMC3002834 | S55 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Study design | epc levels and function were compared between 45 crs patients at baseline and 20 healthy controls. |
39 | PMC3002834 | S56 | ['3a'] | [0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study design | the effects of epo treatment were evaluated in an open-label, randomised design. |
40 | PMC3002834 | S57 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study design | patients received epo treatment (50 iu/kg/week; neorecormon, roche pharmaceuticals, woerden, netherlands) or standard treatment without epo for one year. |
41 | PMC3002834 | S58 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Study design | short-term effects of epo (n =30) versus no epo (n =15) were evaluated after 18 days (3 days after third epo injection), when epo treatment was not yet expected to result in a haematopoietic response. |
42 | PMC3002834 | S59 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Study design | long-term (52 week) effects of epo were assessed in a subgroup of epo-treated patients, who were allowed to increase haemoglobin (hb) levels up to 8.5 mmol/l for men and 8.3 mmol/l for women (n =13), and a non epo-treated group (n =13). |
43 | PMC3002834 | S61 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Plasma measurements | serum epo levels were measured by sandwich chemiluminescent immunoassay (immulite 2000 platform, siemens healthcare diagnostics, breda, netherlands). |
44 | PMC3002834 | S62 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Plasma measurements | endothelial dysfunction, epc mobilising factors and inflammation markers were measured using elisa (e-selectin, vascular cell adhesion molecule-1 (vcam-1), interleukin (il)-6, vegf, sdf-1α (r&d systems, minneapolis, minnesota, usa) and thrombomodulin (diaclone, stamford, connecticut, usa)) or multiplex immunoassay17 (i... |
45 | PMC3002834 | S63 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Plasma measurements | high sensitivity c reactive protein (hscrp) was determined by particle-enhanced immunonephelometry (standard cardio-phase hscrp for bnii, dade behring holding, liederbach, germany). |
46 | PMC3002834 | S64 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Plasma measurements | n-terminal prohormone of brain natriuretic peptide (nt-probnp) was measured using electrochemiluminescense immunoassay (cobas ca6000, roche, mannheim, germany). |
47 | PMC3002834 | S65 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Plasma measurements | samples were measured in duplicate and averaged for analysis. |
48 | PMC3002834 | S67 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Circulating EPC levels | circulating epc were defined as cells positive for haematopoietic stem cell marker cd34 and endothelial marker kinase insert domain receptor (kdr; ie, vegf receptor-2). |
49 | PMC3002834 | S68 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Circulating EPC levels | this cd34+kdr+-epc has previously shown clinical importance by predicting cardiovascular events and death in cardiovascular risk populations.18 19 |
50 | PMC3002834 | S69 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Circulating EPC levels | blood (100 μl) was incubated with anti-cd34-fitc (bd pharmingen, california, usa), anti-kdr-pe (r&d systems) and anti-cd45-pe-cy7 (bd pharmingen) antibodies for 45 min. erythrocytes were lysed and analysed by flow cytometry (beckman coulter, california, usa). |
51 | PMC3002834 | S70 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Circulating EPC levels | circulating hsc and epc were identified as cd34+ and cd34+kdr+ cells in the lymphocyte region of the forward/sideward scatter plot. |
52 | PMC3002834 | S71 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Circulating EPC levels | cell numbers were quantified relative to 105 granulocytes, identified as cd45+ cells with a typical granulocyte distribution. |
53 | PMC3002834 | S72 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Circulating EPC levels | measurements were performed in duplicate and results were averaged. |
54 | PMC3002834 | S73 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Circulating EPC levels | isotype-stained samples served as negative controls. |
55 | PMC3002834 | S75 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outgrowth of EPC in culture | epc outgrowth from mononuclear cells (mnc) was assessed as described previously.3 |
56 | PMC3002834 | S76 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outgrowth of EPC in culture | in brief, mnc were isolated from blood using ficoll density gradient separation (histopaque 1077, sigma, st louis, missouri, usa). |
57 | PMC3002834 | S77 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outgrowth of EPC in culture | to evaluate epc outgrowth in culture, 107 mnc/well were seeded on a human fibronectin (sigma) coated 6-well plate in egm-2 (cambrex, baltimore, maryland, usa), supplemented with accompanying aliquots, 20% fetal calf serum (invitrogen, carlsbad, california, usa), 100 ng/ml recombinant vegf-165 (r&d systems) and antibiot... |
58 | PMC3002834 | S78 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outgrowth of EPC in culture | medium was changed after 4 days to wash non-adherent cells away. |
59 | PMC3002834 | S79 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outgrowth of EPC in culture | after 7 days, cultured epc in selected wells were placed on serum free medium (ebm-2 with hegf, hydrocortisone, ga-1000, r3-igf-1, ascorbic acid, heparin and antibiotics) overnight. |
60 | PMC3002834 | S80 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outgrowth of EPC in culture | conditioned medium was stored for functional experiments and cultured epc were detached by trypsin and cell scraping, and automatically counted using a haemocytometer. |
61 | PMC3002834 | S82 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | In vitro scratch wound assay | the potential of epc outgrowth to excrete paracrine factors that stimulate endothelial cell migration was assessed by in vitro scratch wound assay.20 |
62 | PMC3002834 | S83 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | In vitro scratch wound assay | in brief, epc outgrowth medium was placed on a mechanically scratched confluent human microvascular endothelial cell layer. |
63 | PMC3002834 | S84 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | In vitro scratch wound assay | after 6 h, the extent of scratch closure relative to the starting width was compared between study groups using light photography. |
64 | PMC3002834 | S85 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | In vitro scratch wound assay | each sample was measured in two separate wells and two picture fields per well were examined. |
65 | PMC3002834 | S86 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | In vitro scratch wound assay | results were averaged for data analysis. |
66 | PMC3002834 | S88 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical analysis | data analysis was performed using spss v.15.0 for windows. |
67 | PMC3002834 | S89 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical analysis | data distribution was tested by the kolmogorov–smirnov test. |
68 | PMC3002834 | S90 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical analysis | data are expressed as mean ± sd for parametric data and as median (iqr) for non-parametric data. |
69 | PMC3002834 | S91 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical analysis | differences between groups were analysed using student's t test or the mann–whitney test. |
70 | PMC3002834 | S92 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical analysis | fisher's exact test was used to analyse whether proportions of categories varied by group. |
71 | PMC3002834 | S93 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical analysis | multiple group comparisons were performed using anova with lsd post-hoc testing for which non-parametric data were log-transformed. |
72 | PMC3002834 | S94 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical analysis | correlations were measured by pearson's or spearman's correlation coefficient where appropriate. |
73 | PMC3002834 | S95 | ['12a'] | [0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical analysis | multivariate determinants of log-transformed progenitor cell counts were identified by stepwise multiple linear regression analysis. |
74 | PMC3002834 | S96 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Statistical analysis | a value of p <0.05 was considered statistically significant. |
75 | PMC3016167 | S100 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study treatments | mesobuthus tamulus is not the only venomous scorpion in the state of western maharashtra, but it may be the only dangerously venomous scorpion in the mahad area.24 25 |
76 | PMC3016167 | S101 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study treatments | haffkine biopharma (mumbai) has been manufacturing monovalent anti-scorpion venom serum f(ab)2 against mesobuthus tamulus since 1997 and it has been available for clinical use in a rural setting since 2002. |
77 | PMC3016167 | S102 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study treatments | studies conducted at different times show that the antivenom is potent; 1 ml of reconstituted anti-scorpion venom serum neutralised 1.2 mg of indian red scorpion venom by intravenous route in an in vivo study in mice.35 |
78 | PMC3016167 | S103 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Study treatments | the maximum volume of venom injected in one sting by the indian red scorpion is 1.5 mg, and each ml of antivenom is capable of neutralising 1.2 to 1.5 mg of venom.36 |
79 | PMC3016167 | S104 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study treatments | a single 30 ml dose of haffkine biopharma monovalent antivenom (batch no ss811001, manufacturing date november 2008, expiry date april 2013) was added to 100 ml of normal saline, which was infused intravenously over 30 minutes irrespective of patient’s age. |
80 | PMC3016167 | S105 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study treatments | during infusion the patient was closely observed for reaction to the serum in the form of sudden onset of vomiting, urticaria, hypotension, tachycardia, bronchospasm, angioneurotic oedema, or anaphylaxis. |
81 | PMC3016167 | S106 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study treatments | oral prazosin (batch no ml.nh 138 batch no gk 60372 manufactured 04/2006, expiry 03/2011, and ml.nh 138 batch no gk 80282 manufactured 02/2008, expiry 01/2013) was given at a dose of 250 µg in children up age 18 years and 500 µg in adults. |
82 | PMC3016167 | S107 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study treatments | the same dose was repeated at intervals of 3 hours until the extremities were cold. |
83 | PMC3016167 | S108 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study treatments | similar doses were administered in both randomisation groups. |
84 | PMC3016167 | S109 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study treatments | dehydration owing to vomiting and sweating was corrected by intravenous crystalloid solution. |
85 | PMC3016167 | S110 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study treatments | the prazosin treated group required longer duration and larger volumes of intravenous crystalloid solution than the antivenom plus prazosin group. |
86 | PMC3016167 | S111 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study treatments | patients who developed grade 3 and 4 symptoms were transferred to the intensive care unit. |
87 | PMC3016167 | S112 | ['5'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0] | Study treatments | before discharge all participants were immunised for tetanus. |
88 | PMC3016167 | S114 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outcomes | the primary end point was the proportion of patients achieving resolution of the grade 2 clinical syndrome at the end of 10 hours after administration of the study drugs and prevention of deterioration to grade 3 and 4.18 21 37 |
89 | PMC3016167 | S115 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Outcomes | secondary end points were time required for complete resolution of clinical syndrome, prevention of deterioration to higher grade, doses of prazosin required within 10 hours and overall, and adverse events. |
90 | PMC3016167 | S46 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Trial design | this study and trial were done without the help of any funding agency. |
91 | PMC3016167 | S47 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Trial design | anti-scorpion antivenom was purchased from haffkine biopharma mumbai and given to participants in this trial. |
92 | PMC3016167 | S48 | ['4a'] | [0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Trial design | we proposed to include people admitted with scorpion sting over one year, between march 2009 and february 2010. |
93 | PMC3016167 | S49 | ['3a', '4b'] | [0, 0, 0, 0, 0, 0, 1, 0, 0, 1, 0, 0, 0, 0, 0, 0, 0, 0] | Trial design | this was a randomised (1:1 allocation ratio), parallel group, open label, controlled trial conducted at bawaskar hospital in mahad, a region of india with a population of 20 000, situated 180 km south of mumbai on the mumbai-goa highway. |
94 | PMC3016167 | S50 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Trial design | an independent data and safety monitoring board monitored the trial and had access to the all data. |
95 | PMC3016167 | S51 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Trial design | statistical analysis was done by a statistician in collaboration with the investigators. |
96 | PMC3016167 | S52 | ['0'] | [1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0] | Trial design | the study design was approved by the independent ethics committee of byl medical college mumbai (iec/08/39) and all participants provided written informed consent. |
97 | PMC3016167 | S54 | ['6a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0, 0, 0] | Sample size | the primary efficacy variable was the time required for recovery after venomous scorpion sting. |
98 | PMC3016167 | S55 | ['7a'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0] | Sample size | we estimated that 35 patients in each group would be required to achieve 80% power; α=0.05 to detect a mean difference of four hours in the recovery time between the groups, assuming a mean recovery time of 10 hours (sd 2.5 hours) in the antivenom plus prazosin group and 14 (sd 3) hours for the prazosin alone group. |
99 | PMC3016167 | S57 | ['8a', '8b'] | [0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 1, 1, 0] | Randomisation | a statistician generated the sequentially numbered randomisation list with random block sizes of 4 4 2 4 4 6 2 4 6 6 6 8 4 8 2 using www.randomisation.com. |
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