Number of Patients. The maximum number of patients enrolled in this study will be 30.
Number of Patients. A total of 2400 patients are planned to be enrolled in the study in 11 medical centers.
Number of Patients. 20 Cost per patient:..................................................... 112 # of payments to investigator:........................................ 2
Number of Patients. Up to *** patients will be enrolled; approximately *** patients in the dose escalation phase; approximately *** in the dose expansion. Study Design This is a open-label, safety, *** study with standard 3+3 dose escalation design.
Number of Patients. The Institution and Investigator intend to enrol approximately 100 patients in accordance with the Protocol and in compliance with all applicable laws. The study is being conducted under a policy of managed enrolment. Terumo, in its sole discretion, may either (i) limit or (ii) suspend further recruitment at the Study Site. Počet pacientů: Zdravotnické zařízení a zkoušející plánují registrovat přibližně 100 pacientů v souladu s protokolem a podle platných zákonů. Studie se provádí podle zásady řízené registrace. Společnost Terumo může dle svého výhradního uvážení buď (i) omezit nebo (ii) pozdržet další nábor na pracovišti. Milestones per patient: Milestone 1: eCRF completion of Enrolment including 3 months follow up Milestone 2: eCRF completion of 1 Year Follow up Milestone 3: eCRF completion of OFDI specific questions and CD imaging successfully sent to Terumo. (only applicable to selected sites) Cíle na pacienta: Cíl 1: vyplnění registračních formulářů eCRF včetně 3měsíčního následného sledování Cíl 2: vyplnění formulářů eCRF po 1 roce následného sledování Cíl 3: vyplnění formulářů eCRF s konkrétními otázkami OFDI a zobrazování CD a úspěšné odeslání společnosti Terumo. (vztahuje se pouze na vybraná pracoviště) Number of hours: NA Počet hodin: není k dispozici Reporting: Investigator and Institution undertakes to ensure that Terumo is kept informed about the status and results from the Services, whether patentable or not. Reporting will be done through an electronic database (eCRF) and upon request, through reporting of anonymized source documents for clinical event committee. Hlášení: Zkoušející a zdravotnické zařízení se zavazují, že zajistí, aby společnost Terumo byla informována o stavu a výsledcích služeb, ať už mají potenciál pro patentní řízení či nikoli. Hlášení bude prováděno prostřednictvím elektronické databáze (eCRF) a na základě vyžádání, hlášením dokumentů anonymního zdroje pro komisi klinického hodnocení. Annex II: Payment of Fees Příloha II: Úhrada poplatků Fees Poplatky For the Services performed by the Provider to the satisfaction of TE, the Provider is entitled to the following compensation, including Tax/VAT, upon receipt of a proper invoice: Za služby prováděné poskytovatelem ke spokojenosti společnosti Terumo má poskytovatel nárok na následující odměnu, včetně daně/DPH, na základě přijetí faktury se všemi náležitostmi: TE or its assigned agent shall pay to the Provider the following fixed and invariable amounts upon the successful da...
Number of Patients. The frequency of concurrent (HHV-6+HHV-7) infection activation was significantly higher after then before PBSCT (9.5% and 57.1%, respectively (Fig. 3). 48,1 57,1 0,0 0,0 HHV-6 PBL load in patients with latent/persistent and active HHV-6 infection Fig. 4. HHV-6 PBL load in patients with latent/persistent and active HHV-6 infection 80000 70000 60000 50000 40000 30000 20000 10000 0 Latent/persistent Active The significant increase of mean HHV-6 load in DNA of peripheral blood leukocytes was detected in the period active faze of viral infection 54676 (range: 26867 - 71163) copies/µg DNA then in the period of latent/persistent faze of infection 4781 (range:1548 – 8963) copies/µg DNA. copies/μg DNA HHV-6B genomic sequence only was found in all peripheral blood leukocytes and plasma DNA samples from the donors and recipients. The mean number of days before detecting HHV-7 and HHV-6 reactivation was 11 days (range: 8 -14 days) and 27 days (range: 12-34 days), respectively. Plasma/serum expression levels of cytokines in patients with PBSCT Fig. 5 Significant increase in mean expression levels of pro-inflammatory cytokines XXX-x, XX-0, XX-0x was detected in the plasma/serum samples from the auto- and allo-PBSCT recipients with active viral infection in comparison to the expression levels in patients with latent infection. None of the transplant patients had detectable value of IL-4 and IL-2 in the serums/plasma samples. Plasma/serum expression levels of cytokines in patients with PBSCT IL-1beta 21,86 83,45 IL-6 TNF-alpha XX-0 XX-0 0,00 13,23 5,28 11,69 <2,00 <2,00 <2,00 <2,00 20,00 59,88 40,00 60,00 80,00 100,00 pg/ml Active Latent/persistent Relationship between active beta-herpesviruses infection and the clinical complications development in early period after PBSCT Complication Auto-PBSCT (n=12) Allo-PBSCT (n=5) Active viral infection HHV-7 HHV- 6 + HHV-7 HHV-7 HHV-6 +HHV-7
Number of Patients. Approximately 130 patients will be enrolled; this number may be increased up to approximately 200 patients based upon a blinded sample size re-calculation.
Number of Patients. Below are the corresponding histograms and cumulative frequencies for all appointments, appointments with resident physicians and appointments with medical specialists and for new and return patients, respectively. Service time (resident physician appointments) 180 160 140 120 100 80 60 40 20 0 100.00% 90.00% 80.00% 70.00% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% Service time (minutes) Frequentie Figure 25: Histogram and cumulative frequency of service time for all appointments Figure 26: Histogram and cumulative frequency of service time for resident physicians 120 100 80 60 40 20 0 Service time (medical specialist appointments) 100.00% 90.00% 80.00% 70.00% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% Service time (minutes) Service time (new patients) 160 140 120 100 80 60 40 20 0 100.00% 90.00% 80.00% 70.00% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% Service time (minutes) Number of patients Number of patients Figure 27: Histogram and cumulative frequency of service time for medical specialists Figure 28: Histogram and cumulative frequency of service time for new patients Service time (return patients) 160 140 120 100 80 60 40 20 0 100.00% 90.00% 80.00% 70.00% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% Service time (minutes) Number of patients Figure 29: Histogram and cumulative frequency of service time for return patients Distribution analysis of service time led us to conclude that a Gamma distribution best fits the data (see attachment 3). Statistical analysis (see attachment 9) shows that there is a significant difference between the service times for resident physicians and medical specialists, the former having higher service times. More specifically, as can be seen from table 4, resident physicians have a mean service time of 24.37 minutes (00:24:22) with a standard deviation of 10.285 minutes (00:10:17) and medical specialists have a mean service time of 19.76 minutes (00:19:46) with a standard deviation of 9.035 minutes (00:09:02). Moreover, statistical analysis also led us to conclude that new patients have a significantly higher service time than return patients. New patients have a mean service time of 28.33 minutes (00:23:17) with a standard deviation of 10.47 minutes (00:10:28). Return patients have a mean service time of 22.17 minutes (00:22:10) with a standard deviation of 9.67 minutes (00:09:40). The tables below give the means and standard deviations for all possible combinations of doctor types and patient types. S...
Number of Patients. Approximately 20 patients will be enrolled in this study.
Number of Patients. Barcelona Breast Cancer Survivors Dataset 203 CareAcross Breast Cancer Patients with QoL Questionnaires Filled Out 1,700 Quality on life in patients treated with aromatase inhibitors as adjuvant therapy (Breast cancer – Sörmland) 232 Quality of life depending on type of surgery (Breast cancer – Uppsala) 250 BcBaSe (static database for research purposes based on National Quality Registry for breast cancer) 15,000 Table 1 Breast Cancer Retrospective Datasets For prostate cancer, two retrospective datasets from two partners are available. CareAcross brings a dataset of n = 250 prostate cancer patients with localised or metastatic prostate cancer treated with different treatment approaches. The dataset includes data about tumour- characteristics, treatment strategies, and side effects based on patients’ answers through an online platform as well as data from validated questionnaires (GAD7 for anxiety, PHQ9 for depression). Örebro prostate cancer dataset is a real-world database including patients (n=2340) with localised prostate cancer treated with radiotherapy with curative intention in the Örebro healthcare region and has as aim to be used as a tool to improve the follow- up of those patients. It includes data on patient- and tumour characteristics, treatment approaches, dosimetric parameters regarding radiotherapy, side effects based on direct questions or validated questionnaires (IPSS, IIEF-5) and QoL issues based on a validated questionnaire (LISAT-11).
