Latest database descriptions

Case-Control Study Based on Childhood Cancer Geolocalisation

January 19 2022

To study the influence of several environmental exposures on the risk of childhood cancer - proximity to power lines and exposure to electric and magnetic fields at extremely low frequency - proximity to traffic lanes and environmental exposure to benzene and other pollutants - exposure to living spaces with natural ionising radiation, especially radon and gamma radiation - proximity to industrial sites

Identification of factors allowing a therapeutic anemia management optimization in CKD patients treated with C.E.R.A.

November 26 2021

Primary Objective: To identify the potential factors of optimizing the therapeutic management of renal anemia with C.E.R.A.
Secondary Objectives:
- Analysis of the therapeutic response to C.E.R.A., according to 4 definitions (reach or maintenance of the Hb concentration within the therapeutic target range of [10-12] g/dL, limitation of Hb variability at +/- 1 g/dL from the baseline value, both above criteria, or at least one of the above criteria, after a 3-month treatment period)
- Description of patient and disease characteristics at first C.E.R.A. injection
- Description of the evolution of CKD management (physical examination, laboratory parameters including Hb values and renal function, prior and ongoing concomitant treatments for anemia, as well as concomitant diseases and treatments) under C.E.R.A. treatment
- Search for any associations/correlations between variables and detection of particular profiles.

Prospective pharmaco-epidemiological study aiming to describe the management of relapsed or refractory chronic lymphocytic leukemia (CLL) patients retreated with MabThera®

November 26 2021

Primary Objective: To describe the chemotherapy regimens combined with MabThera® in relapsed or refractory CLL patients having previously received a first or second-line
treatment containing MabThera®
Secondary Objectives:
- Describe efficacy of treatment: overall response (OR), complete response (CR), partial response (PR), progression-free survival (PFS), time to next treatment (TTNT), overall survival (OS) in the total cohort and in the following subgroups: refractory (Yes/No), age (< or >= 70 years), 17p deletion (Yes/No), 11q deletion (Yes/No).
- Describe the choice of chemotherapy regimen in patient subgroups defined as: refractory (Yes/No), age (< or >= 70 years), 17p deletion (Yes/No), 11q deletion (Yes/No)
- Describe MabThera® treatment regimens (dose, number of cycles),
- Describe safety of treatment: all adverse events occurring during the study,
- Describe hospitalizations related to an adverse event throughout the study period.
Exploratory Objectives:
-Analysis of maximal response duration at last line before inclusion will be performed quantitatively and by classes, overall and by age, in all patients and according to number of previous lines of treatment.
- Primary criterion will be also described according to the following subgroups:
- last previous treatment before current relapse included the same/not the same chemotherapy treatment as first induction treatment
- report of Normalized creatinine clearance result < 60 (ml/min/1.73 m²) at baseline (yes/no) (renal insufficiency).
- In patients with HBs antigen positive or anti-HBc antibody positive, analysis of HBV prophylaxis and HBV treatment will be performed by visit
- Multinomial regression on choice of chemotherapy given at first cycle
- Logistic model on response

Therapeutic management of adult or child patients with hemophilia A : A retrospective observational study - HEMONIS study

November 26 2021

Primary Objective: To describe the current therapeutic regimen for moderate and severe HA patients (ITI / on-demand / short-term prophylaxis / long-term prophylaxis) in the MS population.
Secondary Objectives:
- To describe the current therapeutic regimen (ITI / on-demand / short-term prophylaxis / long-term prophylaxis) in severe HA patients in the Sev population.
In both Moderate or Severe (MS) population and Severe (Sev) population :
- To describe the profile of patients with HA
- To describe the current treatment type according to therapeutic regimen, inhibitors status and severity
- To describe patient status regarding medical conditions and disease characteristics (severity, presence of inhibitors)
- To describe the patient’s musculoskeletal complications
In Severe (Sev) population:
- To describe medical history and related conditions
- To describe thrombosis events
- To describe therapeutic management administered to patients with severe HA from January 1, 2000 to the last visit (therapeutic regimens in the 2 years preceding the index date , therapeutic regimen from January 1, 2000 until 2 years preceeding the last visit)
- To describe ITI prescribed treatment from initial diagnosis
- To describe significant events (bleeding) or prevention of physical activities and their management occurring in the 2 years preceeding the last visit.
- To describe all surgeries occurring in the 2 years preceeding the last visit.
Exploratory Objectives:
- To identify factors associated with choice of therapeutic regimen (on-demand vs prophylaxis) in the Sev population with inhibitors status at last visit: “Never inhibitor” or “Tolerized inhibitor”.
- To identify factors associated with choice of therapeutic regimen (Prophylaxis vs on-demand, ITI vs on-demand) in the Sev population with inhibitors status at last visit: “Current inhibitor” .
- To identify factors associated with choice of ITI regimen (no ITI vs ITI) in the Sev population among patients with inhibitors.

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