There are about 9403 clinical studies being (or have been) conducted in Switzerland. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This randomised, double-blind, placebo-controlled clinical trial investigates the neuroprotective effect of rasagiline in patients suffering from a retinal detachment affecting central vision. Based on results from a study in mice suffering from retinal degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a second-generation propargylamine with neuroprotective properties modulating the caspase-dependent pathway of programmed cell death.
Preterm birth is the leading cause of perinatal mortality and morbidity. According to WHO, 15 million children are born prematurely (gestational age < 37 weeks) in the world each year while 7% of them die because of complications associated with prematurity. Despite constant improvement of obstetrical care, the number of preterm births has increased over the last decades and prematurity is still the most frequent cause of prenatal hospitalization in industrialized countries. The American College of Obstetricians and Gynecologists as well as the Royal College of Obstetricians and Gynaecologists recommend nifedipine as a first-line tocolytic in case of acute threatened preterm labour. Clinical experience show however an important variability in treatment response among pregnant women. In spite of its large use in obstetrics as a tocolytic agent, nifedipine is prescribed off-label. As a consequence no international consensus on optimal dose schedule has so far been proposed. Small sample size and heterogeneousness of tocolysis administration protocols make it difficult to compare the little data available on the pharmacokinetics of nifedipine in pregnant women. Nevertheless an important interindividual variability in concentrations has been identified (CV=12-76%) but very few studies have investigated the possible reasons of this variability in pregnant women. Genetic and environmental factors involved in drug distribution and metabolism (e.g. enzymatic activity, CYP 3A5 genotype) might partially explain variability in drug levels and therefore differences in treatment response. The goal of this study is to quantify the variability in nifedipine pharmacokinetics and identify potential genetic and non-genetic sources of variability in nifedipine pharmacokinetics in pregnant women. The relationship between concentration and treatment response will be evaluated and will serve to propose optimal dosage regimen to improve efficacy and reduce side effects associated with this treatment.
Opioids are an effective instrument for patients with acute and chronic pain. Their route of administration ranges from transdermal to subcutaneous application through to Intravenous Patient-Controlled Analgesia (IV-PCA). The use of IV-PCA-pumps has considerable advantages including decreased delay in the administration of opioids from the time requested, individual dose intervals, self -control of their therapy, rapidity and ease of dose titration . These potential benefits, however are balanced by the need for careful assessment of adverse effects, including decreased quality of life because of the patient's sedation, constipation and possible episodes of bradypnoea and desaturation, eventually leading to respiratory depression (RD) requiring treatment. Often described safety features that help prevent overdosing are PCA bolus dose, delay, and lockout interval. Even though the risk of serious, potentially life threatening complications by using IV-PCA without a background infusion was described to be very low (0.24%) compared to other methods of opioid delivery , adverse effects like worrying degrees of hypoxemia and bradypnoea do occur and often remain undetected due to the lack of continuous monitoring. One of the possible causes of patient harm are medication errors associated with PCA administration, a common form of PCA errors, which is a significant source of preventable patient morbidity and hospital resource utilization. The individual patient response to a particular dose of opioids depends on diagnosed or unrecognized comorbidities. Clinical experience has shown that it is not possible to prospectively identify all patients who may be at increased risk. Conventional opioid monitoring protocol may fail to detect frequent episodes of bradypnoea and desaturation measured by the respiratory rate (RR) and Saturation of Peripheral Oxygen (SpO2) because even at a low respiratory rate SpO2 is usually maintained, so that pulse oxymetry might fail to detect respiratory deterioration, particularly if a patient is receiving supplemental oxygen. Therefore, continuous monitoring could be considered more sensitive, especially if it contains the measurement of Partial Pressure of Carbon dioxide (PCO2), which is a good parameter for monitoring ventilatory function. The 'gold standard' method to measure the arterial partial pressure of carbon dioxide (PaCO2) is still the arterial blood gas analysis. But arterial sampling including catheterization or intermittent arterial puncture is invasive and expensive and associated with pain and discomfort for the patient. Therefore cutaneous carbon dioxide tension (PcCO2) measurement was suggested to be used as a non-invasive surrogate measure of PaCO2. SpO2, and tcPCO2, are important clinical parameters that should be used in conjunction with each other. SpO2 reflects oxygenation, while tcPCO2 reflects ventilation; the first can still be normal while the second may herald early changes in respiratory status. Capnography may provide the earliest indication of opioid-induced respiratory depression. It is important to monitor changes from a baseline tcPCO2 level. As the tcPCO2 level starts to increase, early intervention and changes in medication can be made. The present study aims to examine combined oxymetry and transcutaneous capnography using a single earlobe sensor (V-Sign™, Sentec AG, Therwil, Switzerland) in chronic pain patients treated with opioids where non-invasive monitoring of ventilation is needed because ventilatory disturbances are suspected. This may, potentially, improve patient's quality of life.
Background: Physical activity is defined as any bodily movement produced by skeletal muscles resulting in energy expenditure (Caspersen, 1985). According to classical work physiology, energy expenditure was considered as basis for assessing the severity of manual work (Grandjean 1991). Steele et. al. found blue collar workers to report significantly more walking activity, daily step counts and MET min/week than professionals and white collar workers. However, the energy cost of physical activity may not necessarily be equivalent to body movement. Therefore, modern concepts include also other aspects reflecting the amount of workload. Soer et. al. applied an evaluation system consisting 12 work-related tests to establish functional capacity in healthy employees. The assessment included various lifting and energetic tasks as well as coordination exercises. In occupational rehabilitation a balance between workload and work capacity is necessary for professional reintegration. Thus, it is of great value to evaluate a wide range of work requirements across occupational groups in terms of energy expenditure, physical activity and aerobic capacity. Aim: The aim of this study is to examine the amount of physical activity and energy expenditure during a normal working day with focus on differences between occupational groups. Method: To analyze the situation in Switzerland, 300 healthy and full-time employed adults between 18-65 years will be investigated in the Basel region. Participants will be stratified by occupational category according to the ISCO-88 and will then be merged into 3 groups with low-, moderate- and high-intensity occupational activity. By wearing the SenseWear Mini Armband on 7 consecutive days, average daily energy expenditure, activity duration at different intensities and step counts will be assessed during work-time. In addition, individual's aerobic capacity will be determined by the 20-meter shuttle run test. Outlook: This study is expected to provide detailed information about physical work requirements with regard to professional reintegration. For developing adequate intervention and treatment strategies, it is of great value to evaluate performance criteria across occupational groups.
SAKK 21/12 is a stratified, multicenter Phase II first in-human trial with transdermal CR1447 (4-OH-testosterone) and is directed to patients with endocrine responsive-HER2neg and TN-ARpos metastatic or locally advanced breast cancer. The trial will be conducted in Switzerland with max. 90 patients. CR1447 has a very good safety and tolerability profile and combines two mechanisms of action, interaction with the AR and the aromatase enzyme may have a higher activity than drugs with a single mechanism and might offer the possibility of non-chemotherapy based endocrine therapy to the limited treatment options in TN-ARpos BC. Transdermal application of CR1447 might have the advantage to continuously release of 4-OHT into the blood stream, thus omitting a first pass effect. In Phase II the main objective is to assess activity and to determine the efficacy and tolerability of CR1447. Phase II will consist of two strata, into which patients will be stratified according to their hormonal receptor status: Stratum A for patients with endocrine responsive-HER2neg disease, regardless of their AR status and Stratum B for patients with triple-negative and determined ARpos disease. Patients with triple-negative disease tested negative for AR will be excluded from the trial. In both strata patients will be treated with 400 mg of CR1447 until disease progression, patients' wish or physicians' decision to end treatment. Biopsies of one defined metastatic lesion in those patients who gave informed consent will be performed at baseline and within the third week of treatment with CR1447. Measurement of AR expression, expression of downstream targets of ERα, ERβ, PR, AR, angiogenesis and other translational studies as described in this protocol should help confirming the hypothesis of an increased benefit of CR1447 due to its dual action, efficacy of topical application, tolerability and in deciding whether one should proceed to a large randomized trial.
The purpose of this study is to generate detailed insight into which therapies of giant intracranial aneurysms are being conducted, to document the natural history and the outcome of treatment over 5 years after inclusion into the Registry and to follow imaging data of giant aneurysms over years after diagnosis.
The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting. It is a prospective, non-randomized, observational multicenter study evaluating standard of care. For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant. Study endpoints: Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.
The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for study entry are the same for both treatment arms. With the amendment for version 12 of the protocol, patients who have a WNT-activated medulloblastoma with clinically high-risk features can be included in the PNET 5 MB WNT-HR study, and patients with a high-risk SHH medulloblastoma with TP53 mutation (both somatic or germline including mosaicism) can be included in the PNET5 MB SHH-TP53 study. Data on patients with pathogenic germline alteration or cancer predisposition syndrome, who cannot be included in any prospective trial due to unavailability or due to physician or family decision, can be documented within the observational PNET 5 MB registry.
1. Background Chronic Obstructive Pulmonary Disease (COPD) is an inflammatory disease of the lungs, which is most commonly caused by smoking. It is characterized as not fully reversible airflow limitation, chronic cough and dyspnoea. Being the fourth leading cause of death worldwide, COPD is an important public health challenge and can be prevented and treated. It is estimated that at least 400,000 individuals in Switzerland are affected by COPD. This number may increase in the coming years due to increasing nicotine consumption. In response to the rising trend, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) has established new guidelines on the global strategy for diagnosis, management and prevention of COPD. Systematic diagnosis and stratification are crucial for effective treatment measures. As COPD is an irreversible and progressive disease, its treatment aims an early detection and better management, which leads preventing progression. Disease management programs have shown that only patients who understand their exacerbation symptoms can benefit. Moreover, it is a major goal to improve health-related quality of life by reducing symptoms and decelerating disease progression. Spirometry is the golden standard for the diagnosis of COPD, to assess the severity of the obstruction, and as a guide for optimal therapeutic measures. 2. Aim of the study The objective of this project is to establish a COPD cohort database to allow high quality research on diagnosis, treatment, complication and progression of COPD on long-term course. Spirometry should be used consistently for the diagnosis and the monitoring of the development of the disease. Using collected information such as spirometric data, disease progression's data and therapeutic measures should help improve the management and self-management of the patients. 3. Methods 3.1 Study design We are conducting a prospective cohort study, based on COPD patients from northern and western Switzerland, who are managed under primary care setting. Patients with mild to very severe COPD (GLOD stages I-IV) are enrolled in the study. Currently, 67 General practitioners (GPs) are participating in our Study. Each GP recruits 1-20 patients with presumed mild to very severe COPD according to criteria of the Global Initiative for Chronic Obstructive Lung disease [GOLD]. Patients' follow-up-visits occurs at 6-month intervals; their history, symptoms and examination status is recorded. Data is entered into an online database either by the physicians or by study team after receiving the collected data questionnaires by facsimile. Data collection includes demographic data, physical examination, spirometric parameters, medical treatment and exacerbation history besides death. A spirometer (EasyOne™, ndd Medizintechnik AG, Zürich, Switzerland) is used to assess lung function. All participating physicians were instructed on the usage of the spirometer and on how to complete spirometry according to the guidelines. For the assessment of the severity of COPD, we use the spirometric data provided by the GPs. The COPD severity is interpreted according to criteria of the GOLD committee. 3.2 Patient population Patients with newly diagnosed or existing COPD, who are managed in primary-care practices. 3.3 Inclusion criteria - Tiffenau (FEV17FVC) < 70 without reversibility (Increase in FEV1 after inhalation of a bronchodilator <200 ml and <12%). - Age: > 40 years - Both genders - Smokers or ex-smokers of at least 20 pack years. - Informed consent. 3.4 Archiving and Data Retention All study-related records such as medical records, informed consent documents, information regarding participants who discontinued, and other pertinent data will be maintained and therefore retained as long as required by the applicable Swiss regulatory requirements (10 Years). 3.5 Data security The complete data of the study will be entered anonymously into a database. The data is password-protected and can only be accessed by investigators and study members. 4. Publication and authorship 4.1 Publication policy Authorship credit is based on: 1. Substantial contribution to conception and design, acquisition of data, or analysis and interpretation of data. 2. Drafting the article or revising it critically for important intellectual content. 3. Final approval of the version to be published. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.