Search results for "Clinical Protocols"
showing 10 items of 48 documents
SOLTI-1503 PROMETEO TRIAL: combination of talimogene laherparepvec with atezolizumab in early breast cancer
2020
New treatment strategies such as immune checkpoint inhibitors and oncolytic viruses are opening new possibilities in cancer therapy. Preliminary results in melanoma and other tumors showed that the combination of talimogene laherparepvec with an anti-PD-1/PD-L1 or anti-CTLA4 has greater efficacy than either therapy alone, without additional safety concerns beyond those expected for each agent. The presence of residual cancer after neoadjuvant chemotherapy in early breast cancer patients is an unmet medical need. SOLTI-1503 PROMETEO is a window of opportunity trial, which evaluates the combination of talimogene laherparepvec in combination with atezolizumab in women with operable HER2-negati…
Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific …
2013
Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depress…
Mandibular trauma treatment: a comparison of two protocols
2014
Objectives: The aim of this study was to evaluate the treatment of mandibular fractures treated in two European centre in 10 years. Study Design: This study is based on 2 systematic computer-assisted databases that have continuously recorded patients hospitalized with maxillofacial fractures in two centers in Turin, Italy and in Amsterdam, the Netherlands for ten years. Only patients who were admitted for mandibular fractures were considered for this study. Results: Between 2001 and 2010, a total of 752 patients were admitted at Turin hospital with a total of 1167 mandibular fractures not associated with further maxillofacial fractures, whereas 245 patients were admitted at Amsterdam hospit…
Evaluation of satisfaction among relatives of mentally disabled patients who were users of a dental care protocol under general anaesthesia.
2010
Objectives: In the field of action of disease associated with dependence the Third Health Plan of Castilla y Leon aims specifically at promoting the adjustment of health assistance to the needs of disabled people, according to their situation. Our objectives were: General: To know the satisfaction level among relatives or caregivers of people who were treated according to a protocol of dental care for mentally disabled people. Specific: To know if satisfaction is related to any sociodemographic characteristics of patients or to their pathology. Study design: Cross-sectional study by telephone survey, set in the Primary Health Area of Salamanca. The target population includes relatives or ca…
Quantitative sensory testing: a comprehensive protocol for clinical trials.
2004
We have compiled a comprehensive QST protocol as part of the German Research Network on Neuropathic Pain (DFNS) using well established tests for nearly all aspects of somatosensation. This protocol encompasses thermal as well as mechanical testing procedures. Our rationale was to test for patterns of sensory loss (small and large nerve fiber functions) or gain (hyperalgesia, allodynia, hyperpathia), and to assess both cutaneous and deep pain sensitivity. The practicality of the QST protocol was tested in 18 healthy subjects, 21-58 years, half of them female. All subjects were tested bilaterally over face, hand and foot. We determined thermal detection and pain thresholds including a test fo…
First-line cisplatin with docetaxel or vinorelbine in patients with advanced non-small-cell lung cancer: A quality of life directed phase II randomiz…
2009
Abstract Background Quality of life (QoL) has gained greater importance in the management of metastatic non-small-cell lung cancer due to the palliative nature of treatment. Docetaxel (DCT) and cisplatin (CDDP) doublet has been reported to be associated to a better QoL than the weekly vinorelbine (VNR) and CDDP regimen. Recently a newer more tolerated schedule of the VNR/CDDP regimen has been published and is widely employed in medical practice. The impact of these regimens on patients' QoL as well as symptoms control and type and grading chemo-related side-effects has been compared prospectically. Methods Patients received CDDP 75mg/m 2 plus DCT 75mg/m 2 on day 1 every weeks (arm A) or CDD…
Use of topical tranexamic acid in primary total hip arthroplasty. Efficiency and safety. Our experience.
2019
Abstract Background and aim Intravenous tranexamic acid has been shown to reduce bleeding and the need for transfusions in total hip arthroplasty, although it has a theoretical risk of producing thromboembolic phenomena. Recently some papers have been published using the topical application of tranexamic acid, but the ideal administration protocol has not yet been clearly defined. The aim of this paper was to demonstrate that our protocol of topical tranexamic acid is effective and safe. Methods Prospective data collection from a case series of 80 primary hip arthroplasties, in which the following topical tranexamic acid protocol is used: 1.5 g diluted to a total volume of 60 ml were admini…
Job absenteeism and arterial hypertension: results of a hypertension control program.
1992
This study reports the findings of one of the stages of a programme for the detection and control of arterial hypertension, started in I980 in an automobile company with a workforce of 9,782. In the initial screening, 522 hypertensive males were found using epidemiological criteria and 206 of these fulfilled the criteria of definite hypertension. The objective of this study consisted of evaluating, 9 years after the start of the program, the indirect cost in terms of the reduction in the morbidity indicator-temporary work incapacity (TWI). Analysis is based on a comparison of the prevalence of hypertension in the population when the program was begun (6%) and in 1989 (9.8%). It can be obser…
Laboratory control of minimal heparinization during haemodialysis in patients with a risk of haemorrhage
1994
Abstract For patients undergoing dialysis with a high risk of haemorrhage there is no standardized procedure for anticoagulation during extracorporeal circulation. Minimal heparinization with a dose equivalent to half that used for chronic haemodialysis was employed in 49 patients (125 haemodialyses) performed after operative interventions (83.3%), after haemorrhagic events (5.2%) and after invasive investigations (11.5%). Using a biocompatible membrane and a low molecular weight heparin (bolus dose 500-1300 U; continuous infusion 100-400 U) it was possible to complete haemodialysis in 74 cases (Group 0) without clots appearing in the venous bubble trap of the tubing system. In 30 cases (Gr…
Case series of 589 tooth extractions in patients under bisphosphonates therapy. Proposal of a clinical protocol supported by Nd: YAG low-level laser …
2013
Objective: Trauma during dental surgery is a predisposing factor for bisphosphonates (BP)-related osteonecrosis of the jaws (BRONJ). However, about 40% of cases of BRONJ are not related to dental invasive procedures, being probably associated to endodontic or periodontal infections. Extraction of non-treatable teeth is considered a reliable choice, to improve symptoms and to reduce the risk of BRONJ. Here we report our experience of tooth extractions in patients under oral or intravenous BP therapy. Study Design: Two-hundred and seventeen patients (38 males, 179 females; mean age 68.72 ± 11.26 years, range 30 to 83 years) under BP therapy received 589 tooth extractions at the Unit of Oral M…