{"component": "clause", "props": {"groups": [{"snippet": "Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).", "size": 5, "snippet_links": [{"key": "the-study", "type": "clause", "offset": [170, 179]}, {"key": "duration-of", "type": "definition", "offset": [213, 224]}, {"key": "intervention-group", "type": "definition", "offset": [257, 275]}, {"key": "study-duration", "type": "definition", "offset": [589, 603]}], "samples": [{"hash": "lWYnkxVEhDA", "uri": "/contracts/lWYnkxVEhDA#study-population", "label": "Study Protocol", "score": 27.3900318146, "published": true}], "hash": "039ce61bda119759eaf8a71205fd455d", "id": 1}, {"snippet": "All patients who underwent elective surgery with primary anastomosis creation for a first primary colon carcinoma between January the 1, 2013 and December the 31, 2019, and registered in the DCRA were potentially eligible. Data extracted from the DCRA comprised characteristics concerning patient, tumor, surgical and follow\u2212up information. The 30\u2212day follow\u2212up was registered until December 31, 2017, and from January 1, 2018, the 90\u2212day follow\u2212up was registered. Index surgical procedures were divided into right hemicolectomy, transversectomy, left hemicolectomy, sigmoid resection, and subtotal colectomy. AL was defined as a defect of the intestinal wall or abscess at the site of the colorectal anastomosis, for which a reintervention was required within 30 to 90\u2212days from primary resection. Since the date of AL diagnosis is not available in the DCRA, the present study reports the follow\u2212up from index colectomy to reintervention. Reinterventions were divided into two categories: (1) surgical reinterventions including laparoscopic and open surgical reinterventions, and (2) non\u2212surgical reinterventions including radiologic\u2212, endoscopic\u2212, and other unspecified reinterventions. For each type of index colectomy, the occurrence of AL, type of reintervention, and timing of reintervention were determined. Primary outcomes after reoperation were mortality, ICU admission, and stoma construction. Secondary outcomes were prolonged hospital stay (primary admission of >14 days after index procedure), readmission, stoma creation per type (defunctioning ileo or colostomy, end ileo or colostomy), and mortality for patients with and without stoma creation during reoperation. Baseline study population characteristics are reported for patients with and without AL. Outcomes after reoperation were reported for the total study population and for each type of index colectomy. Sub\u2212analyses were performed to assess differences in outcomes for reoperation performed during the weekend vs. week and for different annual hospital volumes. Since the Dutch standard states that hospitals should perform at least 50 colonic resections per year,19 volumes were categorized into low\u2212 (<50), low\u2212intermediate (50\u221275), intermediate\u2212high (76\u2212100), and high (>100 ) volume hospitals. Categorical and dichotomous variables are reported as absolute numbers with percentages and were compared using the \u2587\u2587\u2587\u2587\u2587\u2587\u2587 \u2587\u2587\u2587\u2212square test or \u2587\u2587\u2587\u2587\u2587\u2587\u2212Exact test. Continuous variables are reported as median with interquartile range (IQR), and a Kruskal Wallis rank\u2212sum test was used to assess statistical significance. The time interval between surgery and reoperation was calculated using the date of surgery and the date of reintervention. To visualize the timing of reoperation, the number of reoperations per two days was plotted for each type of resection separately. Statistical significance was defined as a p-value <0.05. RStudio version 1.4.1106 (2021) was used for statistical analyses.", "size": 4, "snippet_links": [{"key": "all-patients", "type": "definition", "offset": [0, 12]}, {"key": "elective-surgery", "type": "definition", "offset": [27, 43]}, {"key": "potentially-eligible", "type": "definition", "offset": [201, 221]}, {"key": "until-december", "type": "clause", "offset": [377, 391]}, {"key": "surgical-procedures", "type": "definition", "offset": [471, 490]}, {"key": "a-defect", "type": "definition", "offset": [628, 636]}, {"key": "the-site", "type": "clause", "offset": [674, 682]}, {"key": "date-of", "type": "clause", "offset": [809, 816]}, {"key": "not-available", "type": "definition", "offset": [833, 846]}, {"key": "study-reports", "type": "clause", "offset": [872, 885]}, {"key": "type-of", "type": "definition", "offset": [1198, 1205]}, {"key": "timing-of", "type": "clause", "offset": [1273, 1282]}, {"key": "hospital-stay", "type": "clause", "offset": [1439, 1452]}, {"key": "days-after", "type": "definition", "offset": [1479, 1489]}, {"key": "baseline-study", "type": "definition", "offset": [1682, 1696]}, {"key": "population-characteristics", "type": "clause", "offset": [1697, 1723]}, {"key": "the-total", "type": "clause", "offset": [1816, 1825]}, {"key": "the-\u2587", "type": "clause", "offset": [2388, 2393]}, {"key": "statistical-significance", "type": "definition", "offset": [2568, 2592]}, {"key": "number-of", "type": "clause", "offset": [2761, 2770]}, {"key": "a-p", "type": "clause", "offset": [2888, 2891]}, {"key": "statistical-analyses", "type": "clause", "offset": [2950, 2970]}], "samples": [{"hash": "hEwjvvnigPf", "uri": "/contracts/hEwjvvnigPf#study-population", "label": "License Agreement Concerning Inclusion of Doctoral Thesis in the Institutional Repository of the University of Leiden", "score": 23.1423683167, "published": true}, {"hash": "7qk4Z06HQds", "uri": "/contracts/7qk4Z06HQds#study-population", "label": "Monitoring Outcomes in Colorectal Cancer Surgery", "score": 23.1423683167, "published": true}, {"hash": "79W3GHV4Q6Y", "uri": "/contracts/79W3GHV4Q6Y#study-population", "label": "License Agreement Concerning Inclusion of Doctoral Thesis in the Institutional Repository of the University of Leiden", "score": 23.1423683167, "published": true}], "hash": "d3887d566eeeefbab2fa67d82b487821", "id": 2}, {"snippet": "All patients who underwent surgery for first primary colon cancer between January the 1, 2013 and December the 31, 2019, and registered in the DCRA were potentially eligible for this study (N=52,035) (Figure 1). For the purpose of this study, the following patients were excluded: patients with a synchronous colorectal carcinoma (N=1,770), patients who underwent emergency surgery (N=6,806), underwent a local excision (N=39), patients in whom no primary anastomosis was constructed (N=2,659), patients with a prior stoma of any type as bridge to surgery which was not reversed during the elective colectomy or patients with a stoma of any type constructed during elective colectomy (N=1,178), patients with missing data on AL (N=3), and proctocolectomy (N=15) were excluded. After exclusion, a total of 39,565 patients were included in the study. E l e c t i v ec ca on lco enr s u r g p r i m a r y a n a s t o m o s i s N = 3 9 , 5 6 5 T o tnau lm b ecor loocfna n c e r p a t i who u n d e r swu re gnet r y -(202 10 91 )3 N = 5 2 , 0 3 5 E x c l u s i o n : - S y n c h r o n o u s C R C , N = 1 , 7 7 0 - E m e r g e n c y s e t t i n g , N = 6 , 8 0 6 - L o c a l e x c i s i o n , N = 3 9 - N o p r i m a r y a n a s t o m o s i s , N = 2 , 6 5 9 - M i s s i n g c a s e s f o r A L , N = 3 - P r o c t o c o l e c t o m y , N = 1 5 Figure 1 presents the flowchart of the present study. Synchronous CRC: synchronous colorectal cancer, AL: anastomotic leakage. The overall AL rate was 4.8% and baseline characteristics are displayed in Table 1. Compared to patients without AL, thosewith ALwere more frequently male (62.5% vs. 52.2%, p<0.001), obese (BMI \u226530 kg/m2 22.7% vs. 19.9%, p=0.009), less healthy (ASA III+ 31.7% vs. 24.8%, p<0.001; CCI II+ 32.7% vs. 28.0%, p<0.001), more often presented with tumor\u2212related complications such as anemia or peritumoral abscess (32.7% vs. 27.4%, p=0.006) and had a more advanced tumor stage (T4 13.5% vs. 10.0%, p<0.001 and M1 11.0% vs. 7.4%, p<0.001). Regarding treatment characteristics, these patients more often received neoadjuvant chemotherapy (3.1% vs.1.6%, p<0.001), more often underwent an open resection (23.8% vs. 16.5%, p<0.001), a multivisceral resection (11.5% vs. 6.5%, p<0.001) or an additional resection for metastasis (5.5% vs. 2.8%, p<0.001). The total number of patients treated at low\u2212volume hospitals was 5,564, which was 7,454 for low-intermediate volume hospitals, 8,163 for intermediate-high volume hospitals, and 18,384 for high volume hospitals. The highest AL rate was found for low volume hospitals (6.0%), which was significantly higher if compared to the other volume categories (low\u2212intermediate volume hospitals 4.3%, intermediate\u2212high volume hospitals 4.7%, high\u2212volume hospitals 4.7%, p<0.001). Age \u226575 13,526 (35.9) 698 (36.6) 0.565 Missing 6 0 Sex Male 19,642 (52.2) 1,191 (62.5) <0.001 Missing 11 0 BMI <18.5 1,103 (2.9) 51 (2.7) 0.009 18.5\u221230.0 29,054 (77.2) 1,421 (74.5) \u226530 7,484 (19.9) 433 (22.7) Missing 17 2 ASA score III+ 9,348 (24.8) 604 (31.7) <0.001 Missing 9 0 CCI II+ 10,619 (28.0) 626 (32.7) <0.001 Tumor complicationA 10,316 (27.4) 579 (32.7) 0.006 Missing 64 1 Neoadjuvant chemotherapy 610 (1.6) 60 (3.1) <0.001 Missing 848 45 Approach Open 6,209 (16.5) 456 (23.8) <0.001 LaparoscopicB 31,008 (82.3) 1,432 (75.1) Missing 441 23 Type of resection Right hemicolectomy 19,507 (51.8) 823 (43.2) <0.001 Transversectomy 813 (2.2) 65 (3.4) Left hemicolectomy 4,106 (10.9) 295 (15.5) Subtotal colectomy 318 (0.8) 58 (3.0) Sigmoid resection 12,729 (33.8) 650 (34.1) Missing 185 16 Stoma as bridge to surgery No, stoma created as bridge to surgery 37,325 (99.1) 1,884 (98.8) 0.184 Yes, reversed during elective colectomy 333 (0.9) 23 (1.2) Multivisceral resection 2,461 (6.5) 219 (11.5) <0.001 Missing 15 0 Additional resection for 1,041 (2.8) 105 (5.5) <0.001 metastases Missing 28 1 T stage T1\u22122 13,980 (37.1) 599 (31.4) <0.001 T3 19,726 (52.4) 1,046 (54.9) T4 3,766 (10.0) 257 (13.5) Missing 186 5 N stage N0 25,307 (67.2) 1,261 (66.1) 0.326 N1\u22122 12,235 (32.5) 641 (33.6) Missing 116 5 M stage M- 34,859 (92.6) 1,698 (89.0) <0.001 M1 2,799 (7.4) 209 (11.0) Table 1: Study population characteristics of patients who underwent colon cancer resection, stratified for anastomotic leakage (non\u2212anastomotic leakage (non\u2212AL) versus anastomotic leakage (AL)). A: tumor complications are preoperative complications caused by the tumor, including peri\u2212tumoral abscess, anemia, perforation, obstruction/ileus. B: laparoscopic procedures include conventional and robot\u2212 assisted laparoscopic procedures. Missing values less than 10% are only presented as absolute numbers. A \u2587\u2587\u2587\u2587\u2587\u2587\u2587 \u2587\u2587\u2587-square test was used to calculate the p value. The AL rate differed significantly among the different index procedures. The lowest AL rate was found for patients who underwent a right hemicolectomy (4.0%), followed by sigmoid resection (4.9%), left hemicolectomy (6.7%), transversectomy (7.4%), and a subtotal colectomy (15.4%) (p<0.001) (Figure 2A). Reinterventions were predominantly surgical, ranging from 81.2% for transversectomy to 92.4% for sigmoid resection (p<0.001) (Figure 2B). The median time to reoperation differed significantly among the index colectomies with the shortest time interval to reoperation for sigmoid resection (4 days, IQR 3\u22126), followed by hemicolectomy (both left and right: 6 days, IQR 4\u22129) and transversectomy (6 days, IQR 3\u22129), and the longest for subtotal colectomy (8 days, IQR 4\u221211) (p<0.001). Figure 3 demonstrates that most reoperations were performed on postoperative day 3\u22124 (N=156 for right hemicolectomy, N=65 for left hemicolectomy, N=240 for sigmoid resection, and N=10 for subtotal colectomy).", "size": 4, "snippet_links": [{"key": "all-patients", "type": "definition", "offset": [0, 12]}, {"key": "potentially-eligible", "type": "definition", "offset": [153, 173]}, {"key": "figure-1", "type": "definition", "offset": [201, 209]}, {"key": "for-the-purpose-of-this", "type": "clause", "offset": [212, 235]}, {"key": "emergency-surgery", "type": "definition", "offset": [364, 381]}, {"key": "missing-data", "type": "definition", "offset": [709, 721]}, {"key": "in-the-study", "type": "clause", "offset": [835, 847]}, {"key": "p-r", "type": "definition", "offset": [888, 891]}, {"key": "s-t", "type": "clause", "offset": [908, 911]}, {"key": "i-s", "type": "clause", "offset": [920, 923]}, {"key": "a-t", "type": "clause", "offset": [977, 980]}, {"key": "s-s", "type": "clause", "offset": [1262, 1265]}, {"key": "a-s-e", "type": "clause", "offset": [1274, 1279]}, {"key": "present-study", "type": "clause", "offset": [1381, 1394]}, {"key": "colorectal-cancer", "type": "clause", "offset": [1425, 1442]}, {"key": "baseline-characteristics", "type": "clause", "offset": [1502, 1526]}, {"key": "table-1", "type": "definition", "offset": [1544, 1551]}, {"key": "an-open", "type": "clause", "offset": [2144, 2151]}, {"key": "an-additional", "type": "clause", "offset": [2245, 2258]}, {"key": "number-of-patients", "type": "clause", "offset": [2320, 2338]}, {"key": "high-volume", "type": "clause", "offset": [2460, 2471]}, {"key": "low-volume", "type": "definition", "offset": [2555, 2565]}, {"key": "significantly-higher", "type": "definition", "offset": [2594, 2614]}, {"key": "type-of", "type": "definition", "offset": [3329, 3336]}, {"key": "characteristics-of", "type": "definition", "offset": [4177, 4195]}, {"key": "caused-by", "type": "clause", "offset": [4400, 4409]}, {"key": "a-\u2587", "type": "clause", "offset": [4655, 4658]}, {"key": "calculate-the", "type": "clause", "offset": [4693, 4706]}, {"key": "p-value", "type": "clause", "offset": [4707, 4714]}, {"key": "figure-3", "type": "clause", "offset": [5501, 5509]}], "samples": [{"hash": "hEwjvvnigPf", "uri": "/contracts/hEwjvvnigPf#study-population", "label": "License Agreement Concerning Inclusion of Doctoral Thesis in the Institutional Repository of the University of Leiden", "score": 23.1423683167, "published": true}, {"hash": "7qk4Z06HQds", "uri": "/contracts/7qk4Z06HQds#study-population", "label": "Monitoring Outcomes in Colorectal Cancer Surgery", "score": 23.1423683167, "published": true}, {"hash": "79W3GHV4Q6Y", "uri": "/contracts/79W3GHV4Q6Y#study-population", "label": "License Agreement Concerning Inclusion of Doctoral Thesis in the Institutional Repository of the University of Leiden", "score": 23.1423683167, "published": true}], "hash": "4def3083d5f46f4e56fcd596012de246", "id": 3}, {"snippet": "This retrospective, single-center study was conducted in accordance with the Declaration of Helsinki (as revised in 2013) and was approved by the Ethics Committee of Fudan University Shanghai Cancer Center. Informed consent was obtained from all individual participants. From March 2017 to June 2022, 147 patients who underwent RP after neoadjuvant ADT and presurgical MRI examinations were retrieved from our picture archiving and communication system according to the following criteria 147 PCa patients undergoing ADT before RP Inclusion \u2022 Clinically significant PCa as confirmed by biopsy before ADT \u2022 With post-ADT pathology confirmed by RP \u2022 Mp-MRI scans within 2 weeks before RP \u2022 More than 3 months with a complete androgen blockade with bicalutamide plus ADT Final study population (n=119) Exclusion \u2022 Any type of chemotherapy or RT before RP (n=18) \u2022 Inadequate image quality (n=10) (Figure 1).", "size": 4, "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [54, 72]}, {"key": "declaration-of-helsinki", "type": "definition", "offset": [77, 100]}, {"key": "approved-by", "type": "clause", "offset": [130, 141]}, {"key": "ethics-committee", "type": "definition", "offset": [146, 162]}, {"key": "informed-consent", "type": "definition", "offset": [207, 223]}, {"key": "individual-participants", "type": "definition", "offset": [246, 269]}, {"key": "march-2017", "type": "clause", "offset": [276, 286]}, {"key": "communication-system", "type": "definition", "offset": [432, 452]}, {"key": "according-to", "type": "definition", "offset": [453, 465]}, {"key": "type-of", "type": "definition", "offset": [815, 822]}, {"key": "image-quality", "type": "clause", "offset": [872, 885]}, {"key": "figure-1", "type": "definition", "offset": [894, 902]}], "samples": [{"hash": "c6wJiG2JxZu", "uri": "/contracts/c6wJiG2JxZu#study-population", "label": "Research Article", "score": 33.2698974609, "published": true}, {"hash": "kdfwXN2qQ8", "uri": "/contracts/kdfwXN2qQ8#study-population", "label": "Diagnostic Efficacy and Interobserver Agreement Study", "score": 33.2616844177, "published": true}, {"hash": "bn9SNj1JNiy", "uri": "/contracts/bn9SNj1JNiy#study-population", "label": "Diagnostic Efficacy and Interobserver Agreement Study", "score": 33.2479972839, "published": true}], "hash": "7e6be39b487d7f84585ee9e112d87fca", "id": 4}, {"snippet": "Subjects with postmenopausal osteoporosis who completed the End-of-Treatment Visit (Visit 9) for Study BA058-05-003 and were previously randomized to either blinded Abaloparatide-SC or blinded Placebo are eligible for inclusion into this Extension Study provided that they fulfill the Inclusion/Exclusion criteria described below.", "size": 4, "snippet_links": [{"key": "treatment-visit", "type": "definition", "offset": [67, 82]}, {"key": "provided-that", "type": "clause", "offset": [254, 267]}, {"key": "exclusion-criteria", "type": "clause", "offset": [295, 313]}], "samples": [{"hash": "b8Xw4kE7XvU", "uri": "/contracts/b8Xw4kE7XvU#study-population", "label": "Clinical Trial Services Agreement (Radius Health, Inc.)", "score": 25.1492137909, "published": true}, {"hash": "9GjiQ2386lL", "uri": "/contracts/9GjiQ2386lL#study-population", "label": "Clinical Trial Services Agreement (Radius Health, Inc.)", "score": 24.3415470123, "published": true}], "hash": "cdad899983bd7b3fc60bb69799c14e29", "id": 5}, {"snippet": "The study population in this protocol is comprised of otherwise healthy ambulatory postmenopausal women who:\n1. have participated in Study BA058-05-003,\n2. were randomized to either BA058 Injection 80 \u00b5g/Placebo,\n3. have completed the End-of-Treatment Visit (Visit 9 in Study BA058-05-003), and\n4. have provided a new written informed consent for this protocol. Subjects will not be enrolled if they experienced treatment-related SAE or were withdrawn from Study BA058-05-003 for any reason.", "size": 4, "snippet_links": [{"key": "the-study", "type": "clause", "offset": [0, 9]}, {"key": "comprised-of", "type": "definition", "offset": [41, 53]}, {"key": "treatment-visit", "type": "definition", "offset": [242, 257]}, {"key": "written-informed-consent", "type": "clause", "offset": [318, 342]}, {"key": "for-any-reason", "type": "clause", "offset": [476, 490]}], "samples": [{"hash": "eUgAqC1R4st", "uri": "/contracts/eUgAqC1R4st#study-population", "label": "Clinical Trial Services Agreement (Radius Health, Inc.)", "score": 22.9452438354, "published": true}], "hash": "db01efe83f5b5b9c2889215153250407", "id": 6}, {"snippet": "\u200c People with a diagnosis of CF who meet all eligibility criteria will be eligible for participation in this protocol. Study A will enroll approximately 400 subjects (approximately 200 randomized to discontinue hypertonic saline and 200 to continue hypertonic saline). Study B will enroll approximately 400 subjects (approximately 200 randomized to discontinue dornase alfa and 200 to continue dornase alfa). It is estimated that approximately 920 unique people with CF will be randomized in this master protocol, and that a subset of people with CF on both hypertonic saline and dornase alfa will enroll in both Study A and Study B. \u25aa MBW Assessment: We anticipate that up to 400 subjects will provide data for the MBW assessment.", "size": 3, "snippet_links": [{"key": "eligibility-criteria", "type": "clause", "offset": [45, 65]}, {"key": "will-provide", "type": "clause", "offset": [690, 702]}], "samples": [{"hash": "b3LKoLHYxAg", "uri": "/contracts/b3LKoLHYxAg#study-population", "label": "Protocol Agreement", "score": 28.953004837, "published": true}, {"hash": "kg1IxPHbimp", "uri": "/contracts/kg1IxPHbimp#study-population", "label": "Protocol Agreement", "score": 28.9038925171, "published": true}, {"hash": "cRBREr2pyYU", "uri": "/contracts/cRBREr2pyYU#study-population", "label": "Protocol Agreement", "score": 28.9038925171, "published": true}], "hash": "933d07c16de2c5c918b40033ef358fd9", "id": 7}, {"snippet": "490 schools from the canton of Zurich were invited and 37 participated. 3870 children aged 6-17 years took part. For 3079 we had questionnaires with information on wheeze and exertional wheeze from both parents and children (Table 1). FeNO results were available for 2762 children (median 12ppb, interquartile range [IQR] 7-21) and FVC measurements for 2217 (median 87%, IQR 82-91). Most questionnaires were completed by the mothers (n=1765, 57%). 667 children (22%) helped their parents to complete the questionnaire. Parents of 425 children (14%) had a history of asthma. Table 1: Sociodemographic characteristics of schoolchildren in the \u2587\u2587\u2587\u2587 study (N=3079). n (%) Male sex 1519 (49) Age in years, median (range) 12.3 (6.0-17.2) Who answered the parental questionnaire Mother alone 1765 (57) Father alone 406 (13) Mother and father 202 (7) One or both parents and the child 667 (22) Other 28 (1) Child born in Switzerland 2726 (89) Mother born in Switzerland 1764 (58) Father born in Switzerland 1859 (60) Number of children per household One or two 2073 (67) More than two 926 (30) Urbanisation degree Large urban area 1338 (44)", "size": 3, "snippet_links": [{"key": "information-on", "type": "clause", "offset": [149, 163]}, {"key": "table-1", "type": "definition", "offset": [225, 232]}, {"key": "completed-by", "type": "clause", "offset": [408, 420]}, {"key": "complete-the", "type": "clause", "offset": [491, 503]}, {"key": "characteristics-of", "type": "definition", "offset": [600, 618]}, {"key": "the-\u2587", "type": "clause", "offset": [637, 642]}, {"key": "the-parental", "type": "clause", "offset": [745, 757]}, {"key": "the-child", "type": "clause", "offset": [867, 876]}, {"key": "number-of-children", "type": "clause", "offset": [1009, 1027]}, {"key": "large-urban-area", "type": "definition", "offset": [1106, 1122]}], "samples": [{"hash": "j8yKn9F2jQ", "uri": "/contracts/j8yKn9F2jQ#study-population", "label": "Research Agreement", "score": 24.6057491302, "published": true}, {"hash": "KVuaw9FMN", "uri": "/contracts/KVuaw9FMN#study-population", "label": "Research Agreement", "score": 24.6057491302, "published": true}, {"hash": "3Qv64rnxsrv", "uri": "/contracts/3Qv64rnxsrv#study-population", "label": "Research Study", "score": 24.6057491302, "published": true}], "hash": "4c06077f948294955efaaf9be0c17789", "id": 8}, {"snippet": "This study was performed in a single university center and was approved by our institutional review board. Written informed consent was obtained from all patients. All patients with clinical suspicion of CAD and after a cardiological evaluation were prospectively included.", "size": 3, "snippet_links": [{"key": "university-center", "type": "definition", "offset": [37, 54]}, {"key": "approved-by", "type": "clause", "offset": [63, 74]}, {"key": "institutional-review-board", "type": "clause", "offset": [79, 105]}, {"key": "written-informed-consent", "type": "clause", "offset": [107, 131]}, {"key": "all-patients", "type": "definition", "offset": [150, 162]}], "samples": [{"hash": "9gnofseVkdf", "uri": "/contracts/9gnofseVkdf#study-population", "label": "Research Article", "score": 23.9000682831, "published": true}, {"hash": "jBDctIHcclh", "uri": "/contracts/jBDctIHcclh#study-population", "label": "Research Article", "score": 23.8548946381, "published": true}, {"hash": "aY69o2uxjtZ", "uri": "/contracts/aY69o2uxjtZ#study-population", "label": "Research Article", "score": 23.7973995209, "published": true}], "hash": "8859b34a38ded9154c2ab5316c6ef532", "id": 9}, {"snippet": "The study population in this protocol is the population recommended by Regulatory Authorities (17-19) for the clinical evaluation of PTH and PTH-like drugs in this indication: postmenopausal women (50 to 85 years of age) who are more than 5 years post menopause and whose menopause has been confirmed by an elevated serum FSH and a BMD T-score of <-2.5 (2.5 SD below the population norm) and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. However, postmenopausal women older than 65 who meet the above fracture criteria but have a T-score < -2.0 and > -5.0 may be enrolled. In addition, women older than 65 who do not meet the fracture criteria may also be enrolled if their T-score is <-3.0 and > -5.0. Women who are intolerant of bisphosphonates as outlined in exclusion criterion # 17 (Section 0) and meet the above criteria will also be allowed to enroll. Based on midpoint demographics of the proposed study population, the anticipated 10-year fracture rate in Study BA058-05-003 is estimated to fall within the recommended ranges in the relevant guideline (CPMP/EWP/552/95 Rev.2) when calculated using the FRAX assessment tool (\u2587\u2587\u2587\u2587://\u2587\u2587\u2587.\u2587\u2587\u2587\u2587.\u2587\u2587.\u2587\u2587/FRAX/). A sample size of 622 patients per treatment arm provides 90% power at a two-sided alpha of 0.05 to detect a difference of 4% between treatments, assuming a vertebral fracture rate of 7% in placebo patients and 3% in BA058 80 \u00b5g for injection-treated patients when the large scale approximation of the binomial method is employed. This superiority assessment infers a relative risk reduction of 57% and presupposes the availability of a pretreatment and post-treatment radiological assessment. To ensure a per protocol population of 622 patients, an overall sample size of 800 patients per treatment arm will be recruited, anticipating that approximately 20% of patients may not have a second evaluable X-ray film available for analysis. Prior studies have demonstrated that approximately 20% of enrolled patients drop out over the lengthy period of the study and a further proportion (10%) fail to provide an evaluable End-of-Treatment X-ray, therefore a sample size of 800 patients per arm is proposed.", "size": 3, "snippet_links": [{"key": "the-study", "type": "clause", "offset": [0, 9]}, {"key": "by-regulatory-authorities", "type": "clause", "offset": [68, 93]}, {"key": "clinical-evaluation", "type": "definition", "offset": [110, 129]}, {"key": "years-of-age", "type": "clause", "offset": [207, 219]}, {"key": "lumbar-spine", "type": "clause", "offset": [406, 418]}, {"key": "dual-energy", "type": "definition", "offset": [444, 455]}, {"key": "evidence-of", "type": "definition", "offset": [500, 511]}, {"key": "a-t", "type": "clause", "offset": [798, 801]}, {"key": "in-addition", "type": "clause", "offset": [843, 854]}, {"key": "based-on", "type": "definition", "offset": [1129, 1137]}, {"key": "proposed-study", "type": "definition", "offset": [1167, 1181]}, {"key": "the-relevant", "type": "clause", "offset": [1308, 1320]}, {"key": "assessment-tool", "type": "definition", "offset": [1386, 1401]}, {"key": "sample-size", "type": "clause", "offset": [1435, 1446]}, {"key": "rate-of", "type": "clause", "offset": [1608, 1615]}, {"key": "large-scale", "type": "definition", "offset": [1701, 1712]}, {"key": "reduction-of", "type": "clause", "offset": [1814, 1826]}, {"key": "availability-of", "type": "clause", "offset": [1851, 1866]}, {"key": "to-ensure", "type": "clause", "offset": [1926, 1935]}, {"key": "per-protocol-population", "type": "clause", "offset": [1938, 1961]}, {"key": "period-of", "type": "clause", "offset": [2272, 2281]}, {"key": "to-provide", "type": "clause", "offset": [2328, 2338]}], "samples": [{"hash": "f21WLmDgie4", "uri": "/contracts/f21WLmDgie4#study-population", "label": "Work Statement (Radius Health, Inc.)", "score": 26.1854896545, "published": true}, {"hash": "7aqotpZoR95", "uri": "/contracts/7aqotpZoR95#study-population", "label": "Clinical Trial Services Agreement (Radius Health, Inc.)", "score": 22.8097190857, "published": true}, {"hash": "fhKhN0k6qG0", "uri": "/contracts/fhKhN0k6qG0#study-population", "label": "Clinical Trial Services Agreement (Radius Health, Inc.)", "score": 22.7440109253, "published": true}], "hash": "89fda6f5845568b0c77d823a2597d0d7", "id": 10}], "next_curs": "ClkSU2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjULEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhlzdHVkeS1wb3B1bGF0aW9uIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"children": [["exclusion-criteria", "Exclusion Criteria"], ["inclusion-criteria", "Inclusion Criteria"], ["definition-of-udca-failure", "Definition of UDCA Failure"], ["prohibitions-and-restrictions", "Prohibitions and Restrictions"], ["withdrawal-of-subjects-from-the-study", "Withdrawal of Subjects From the Study"]], "title": "Study Population", "parents": [["methods", "Methods"], ["study-duration", "Study Duration"], ["miscellaneous", "Miscellaneous"], ["exploratory", "Exploratory"], ["study-design", "Study Design"]], "size": 270, "id": "study-population", "related": [["population", "Population", "Population"], ["target-population", "Target Population", "Target Population"], ["study", "Study", "Study"], ["screening", "Screening", "Screening"], ["protocol", "Protocol", "Protocol"]], "related_snippets": [], "updated": "2025-07-23T06:00:56+00:00", "also_ask": [], "drafting_tip": null, "explanation": "The Study Population clause defines the specific group of individuals who are eligible to participate in a research study. It typically outlines inclusion and exclusion criteria, such as age range, medical condition, or other demographic and clinical characteristics that participants must meet. By clearly specifying who can and cannot be enrolled, this clause ensures that the study results are relevant to the intended population and helps maintain the integrity and validity of the research."}, "json": true, "cursor": ""}}