Study Population. The study was based at the San Francisco KPNC Anal Cancer Screening Clinic. We enrolled men who were identified as positive for HIV through the Kaiser HIV registry, who were aged ≥ 18 years, who were not diag- nosed with anal cancer before enrollment, and who pro- vided informed consent. In total, 363 men were enrolled between August 2009 and June 2010. The study was reviewed and approved by the institutional review boards at KPNC and at the National Cancer Institute. All partici- pants were asked to complete a self-administered ques- tionnaire to collect risk factor information. Additional information regarding HIV status and medication, sexu- ally transmitted diseases, and histopathology results were abstracted from the KPNC clinical database. For 87 of the 271 subjects without biopsy-proven AIN2 or AIN3 at the time of enrollment, follow-up infor- mation concerning outcomes from additional clinic visits up to December 2011 was available and included in the analysis to correct for the possible imperfect sensitivity of high-resolution anoscopy (HRA).13,15 Clinical Examination, Evaluation, and Results During the clinical examination, 2 specimens were col- lected by inserting a wet flocked nylon swab16 into the anal canal up to the distal rectal vault and withdrawing with rotation and lateral pressure. Both specimens were trans- ferred to PreservCyt medium (Hologic, Bedford, Mass). A third specimen was collected for routine testing for Chla- mydia trachomatis and Neisseria gonorrhea. After specimen collection, participants underwent a digital anorectal ex- amination followed by HRA. All lesions that appeared sus- picious on HRA were biopsied and sent for routine histopathological review by KPNC pathologists, and were subsequently graded as condyloma or AIN1 through AIN3. No cancers were observed in this study population. From the first specimen, a ThinPrep slide (Hologic) was prepared for routine Xxxxxxxxxxxx staining and xxxxx- xxxxx. Two pathologists (T.D. and D.T.) reviewed the slides independently. Cytology results were reported anal- ogous to the Bethesda classification17 for cervical cytology except when otherwise noted. The following categories were used: negative for intraepithelial lesion or malig- xxxxx (NILM); ASC-US; atypical squamous cells cannot rule out high-grade squamous intraepithelial lesion (HSIL) (ASC-H); low-grade squamous intraepithelial lesion (LSIL); HSIL, favor AIN2 (HSIL-AIN2); and HSIL-AIN3. ASC-H, HSIL-AIN2, and HSIL-AIN3 were co...
Study Population. Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 230 to be assigned to the study: n = 120 to be analysed: n = 120 Duration of intervention per patient of the intervention group: minimum 21 days/3 weeks until patient’s weight >2000g, averaged 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months following enterostomy closure (12- month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 months of overall study duration).
Study Population. 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−up information. The 30−day follow−up was registered until December 31, 2017, and from January 1, 2018, the 90−day follow−up was registered. Outcomes and definitions 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−days from primary resection. Since the date of AL diagnosis is not available in the DCRA, the present study reports the follow−up from index colectomy to reintervention. Reinterventions were divided into two categories: (1) surgical reinterventions including laparoscopic and open surgical reinterventions, and (2) non−surgical reinterventions including radiologic−, endoscopic−, 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. Statistical analyses 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−analyses 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− (<50), low−intermediate (50−75), intermediate−high (76−100), and high (>100 ) volume hospitals. Categorical and dichotomous variables are reported as absolute numbers with percentages and were compared using the Xxxxxxx Xxx−square test or Xxxxxx−Exact test. Continuous varia...
Study Population. 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. FIGURE 1: Study Flowchart 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 n t s 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 ≥30 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−related 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−volume hospitals was 5,564, which was 7,454 for low-intermediate volume hospitals, 8,163 for intermediate-high v...
Study Population. The study population in this protocol is comprised of otherwise healthy ambulatory postmenopausal women who:
Study Population. It is a cross-sectional study involving patients referred for the Pulmonary Circulation Unit of Hospital das Clínicas of the Federal University of Minas Gerais (HC/UFMG), a local PH reference center, in Belo Horizonte, Minas Gerais, in the period from September, 2004 to April, 2015. It includes all 18-year-old or older patients, who were evaluated in an ambulatory basis, and had a clinical and laboratory suspicion of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH), a high or intermediate probability by TTE of pulmonary hypertension and who underwent RHC to confirm diagnosis. A maximum 6-month interval was established between the TTE and the RHC. Patients with diagnosis of PH due to left heart disease (group 2), associated with pulmonary diseases and/or hypoxemia (group 3) and with unclear and/or multifactorial mechanisms (group 5) were not eligible for this study, since RHC is not usually indicated for the diagnosis of patients with pre-defined criteria for these PH groups [1, 3]. Echocardiography and right heart catheterization This study was approved by UFMG’s Research Ethics Committee (ETIC nr. 1.057.219/2015), and all participants who agreed to participate signed the Term of Informed Consent. TTE and RHC examinations were requested according to the protocol and performed in health care units authorized by SUS’s municipal public system. The evaluation by TTE took into consideration echocardiographic variables suggestive of PH, the peak of TRV, the RAP and the sPAP, estimated by the modified form of Bernoulli’s equation: sPAP = 4TRV² + RAP. The RAP was estimated during the inspiratory maneuver as follows: for diameter of the inferior vena cava (IVC) smaller than 2.1cm associated with its collapse > 50%, estimated RAP = 3mmHg (0-5mmHg); for diameter of the IVC larger than 2.1cm with its collapse < 50%, RAP = 15mmHg (10-20mmHg). An intermediate value of 8mmHg (5-10mmHg) was used when these criteria were not met [4, 10]. Other echocardiographic parameters suggestive of PH were the presence in at least two of the following three categories: the ventricles (right ventricle/left ventricle basal diameter ratio > 1 and/or flattening of the interventricular septum); the pulmonary artery (acceleration time in the pulmonary artery < 105ms and/or increased pulmonary regurgitation velocity > 2.2m/sec and/or increased diameter of pulmonary artery > 25mm); and the IVC and right atrium (diameter of the IVC larger than 2.1cm...
Study Population. 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.
Study Population. 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 XXXX 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)
Study Population. All subjects will have a histologically-confirmed diagnosis of GBM (WHO Grade IV), and an unmethylated MGMT status, as confirmed by PCR or alternative genomic analysis. Prior to study entry, subjects will have had optimal surgical resection and subsequent treatment with radiotherapy and temozolomide, in accordance with the ‘Xxxxx regimen’. Subjects who have had disease progression or recurrence subsequent to radiotherapy treatment will not be eligible. Other eligibility criteria will be as commonly deployed for oncology studies. Both male and female subjects will be recruited.
Study Population. 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 (xxxx://xxx.xxxx.xx.xx/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 µg 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 Attachment 2, Attachment E-19 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.
