In 2007, leading international experts in the field of inflammatory bowel disease recommended intravenous iron supplements over oral iron supplements because they were more effective and easier to tolerate.

The Helsana insurance database provided data from adults (aged 18 or older) living in Switzerland, who suffered from Crohn's disease. Helsana is a Swiss health insurance company that covers 18% of the Swiss population (1.2 million individuals). Helsana anonymised data (stripping names, date of birth and address). Data were automatically generated at Helsana quarters, and required no additional manipulation. We analysed the data to determine what percentage of patients with inflammatory bowel disease were prescribed iron therapy, and described the dynamics of intravenous versus oral iron prescription.

This project was based on a study protocol that defines the exact procedures to be used. It included a relatively large number of persons and was not based on individual cases ("method-driven search for generalizable knowledge", defined as research by HRA). The goal was to determine what percentage of patients with inflammatory bowel disease was prescribed iron therapy, and to describe the dynamics of intravenous versus oral iron prescription. The Helsana insurance database provided data from adults who lived in Switzerland and suffered from Crohn's disease ("health-related personal data"). Helsana’s database was automatically generated, and required no additional manipulation. Data were anonymized by an independent institution (Helsana), not involved in the project and separated in time and space. The anonymised database did not include personal identifiers (insurance number, name, date of birth or address). This "research that involves anonymised health-related data" fell outside the scope of HRA.

Physical activity is defined as bodily movements produced by skeletal muscles that result in energy expenditure. This study measured the amount of physical activity, based energy expenditure and other performance criteria that people use during a normal working day. The study focused on differences between occupational categories. The results of this study were used to develope a campaign to prevent sedentary behaviour.

300 healthy adults (aged 18-65 years), employed full-time in Canton Basel in Switzerland, were enrolled in the study. Participants were stratified by occupational category according to the ISCO-88, and were then grouped into 3 classes (low, middle and high occupational activity). Data on duration of average daily activity, total and active energy expenditure, and daily step counts were collected over 7 consecutive days, using a Sense Wear Mini bracelet (no CE-marking). Participants were asked to wear the Sense Wear Mini bracelet during working hours. The primary outcome was difference in average daily active energy expenditure during working time between the occupational categories.

This project was based on a study protocol that defines the exact procedures to be used. It included a relatively large number of persons and was not based on individual cases ("method-driven search for generalizable knowledge", defined as research by HRA). 300 healthy adults ("persons") employed full-time employed Canton Basel, Switzerland, were asked to register their energy expenditure during working time by wearing a Sense Wear Mini bracelet (no CE-marking). The investigator measured the difference in average daily active energy expenditure during working hours for the different occupational categories, defined according to ISCO-88 ("research concerning the structure and function of the human body").

Somatoform disorders are characterised by physical symptoms that are not fully explained by a general medical condition. Somatoform disorders are common, but many healthcare workers are confused by the diagnostic terminology and are reluctant to use these diagnostic labels.

Child psychiatrists, forensic psychiatrists, gastroenterologists, and other physicians from different practice settings were identified through professional societies, like the Academy of Psychosomatic Medicine, American Psychiatric Association, and the American College of Physicians. They were invited to respond to an anonymous Internet survey. By eliciting the views of physicians who see patients with somatoform disorders, we explored their confusion about diagnostic terminology and their reluctance to use these diagnostic labels.

This project was based on a study protocol, in which the exact procedures used to generate generalizable data (method-driven search for generalizable knowledge) were defined. Researchers used a web-based survey to anonymously collect (“anonymously collected data”) data from physicians. The survey contained questions that elicited physicians’ views on disorders that may include physical symptoms not fully explained by a general medical condition. The aim of the study was to explore confusion about diagnostic terminology, and physicians’ reluctance to use these diagnostic labels.

Human metapneumovirus is a relatively new addition to the many viruses that cause respiratory illness in infants and children. Data on the association of human metapneumovirus with neurologic complications is limited.

In this report, we described two toddlers with human metapneumovirus infection who presented in status epilepticus and went on to develop respiratory failure. Data was collected from the routine hospital health record.

This project was not based on a study protocol, and did not define the exact procedures used to identify and describe the cases. Instead it described two cases identified during routine clinical practice. Thus, it was not "method-driven search for generalizable knowledge". It is not classified as research by the HRA.

In literature there is general consensus that using a mirror improves proprioception. During rehabilitation, a mirror is very useful for improving stability. In some sports, such as dancing, mirrors are widely used in training. This study evaluated the effectiveness of physiotherapy with mirror on balance in young dancers.

This study included young dancers (aged 19-25) suffering from chronic knee pain. They were randomly assigned to receive physiotherapy, one to one, with a mirror (mirror- group) or without a mirror (non-mirror group). Their balance was evaluated by BESS (Balance Error Scoring System), which consists of three stances (double limb, single limb, and tandem) on two surfaces (firm and foam). Errors were assessed at each stance and summed to create the two subtotal scores (firm and foam surface) and the final total score (BESS). The BESS was measured at recruitment (T0) and again after 6 months of dance lessons (T1). Primary outcome was difference in total BESS between the groups.

This project was based on a study protocol that defined the exact procedures to be used. It included a relatively large number of persons and was not based on individual cases ("method-driven search for generalizable knowledge", defined as research by HRA). Female dancers ("persons"), between 19-25 years old, suffering from chronic knee pain, were randomly assigned to take ballet lessons with or without a mirror. This study investigated the effect of using a mirror on the dancers’ balance ("research concerning function of the human body").

Migraine and other acute primary headaches are treated with a variety of parenteral medications in the emergency department. It is not clear which medication is best to prescribe to primary headache patients when they are discharged. This study compared the efficacy of oral sumatriptan to naproxen for treatment of post-ED recurrent primary headache.

Adults aged 18 years or older who suffered from headache recurrence after discharge from an emergency department were randomized to either naproxen (Trade®) 500 mg or sumatriptan (Sumatriptan Spirig HC®) 100 mg. This was an open trial: patients and physicians knew who was given which medication. Both products were provided in the original package. The packages had trial-specific labels and were handed out by a hospital pharmacist. Patients were followed-up by telephone 48 hours after emergency department discharge. The primary outcome was change in pain intensity, measured during a two-hour period after ingestion. The change in the group that received 500 mg naproxen (Trade®) was compared to the change in the group that received 100 mg sumatriptan (Sumatriptan Spirig HC®). This difference was measured on a validated 11-point (0–10) verbal Numerical Rating Scale (NRS).

This project was based on a study protocol which defined the exact procedures to be used. The study is designed to answer a disease related research question. It includes a relatively large number of persons and is not based on individual cases ("method-driven search for generalizable knowledge"); thus, it is classified as research according to HRA). Adults (“persons”) who suffered from headache ("research concerning human diseases") after discharge from an emergency department were treated with either 500 mg naproxen (Trade®) or 100 mg sumatriptan (Sumatriptan Spirig HC®).

Needle thoracotomy is an emergent procedure designed to relieve tension pneumothorax. The procedure often fails because the needle does not penetrate into the thoracic cavity. Advanced Trauma Life Support guidelines recommend placement in the second intercostal space, midclavicular line, using a 5-cm needle. This study was evaluated placement in the fifth intercostal space, midaxillary line, where tube thoracotomy is routinely performed.

Twenty unpreserved adult cadavers were evaluated. A standard 14-gauge 5-cm needle was placed in both the fifth intercostal space at the midaxillary line and the traditional second intercostal space at the midclavicular line, in both the right and left chest walls. The needles were secured and thoracotomy was then performed to assess penetration into the pleural cavity. The rate of successful needle placement between fifth intercostal space at the midaxillary line, and the traditional second intercostal space at the midclavicular line on the right and left sites, was compared.

Unpreserved adult cadavers ("deceased persons") were used in this research project.

Migraine and other acute primary headaches are treated with a variety of parenteral medications in the emergency department. It is not clear which medication is best to prescribe to primary headache patients when they are discharged. This study compared the efficacy of oral sumatriptan to naproxen for treatment of post-ED recurrent primary headache.

Adults aged 18 years or older who suffered from headache recurrence after discharge from an emergency department were randomized to either naproxen (Trade®) 500 mg or sumatriptan (Sumatriptan Spirig HC®) 100 mg. This was an open trial: patients and physicians knew who was given which medication. Both products were provided in the original package. The packages had trial-specific labels and were handed out by a hospital pharmacist. Patients were followed-up by telephone 48 hours after emergency department discharge. The primary outcome was change in pain intensity, measured during a two-hour period after ingestion. The change in the group that received 500 mg naproxen (Trade®) was compared to the change in the group that received 100 mg sumatriptan (Sumatriptan Spirig HC®). This difference was measured on a validated 11-point (0–10) verbal Numerical Rating Scale (NRS).

Adults ("persons") who suffered from headache after discharge from an emergency department were included in this research project.

Obesity is highly heritable, and researchers are identifying the specific genes involved. Discovering the mechanisms through which obesity-related genes influence weight will help pinpoint novel targets for intervention. This study tested the hypothesis that satiety responsiveness is an intermediate behavioural phenotype associated with genetic predisposition to obesity in children.

We used genetic data that was collected previously in a population-based twin birth cohort, with twins born in 1996 (National Twins Cohort). In the original cohort study children made up the cohort; one child was randomly selected from each twin pair. Buccal swabs were used to extract DNA. Genome-wide genotyping was done with SNP array, using standard experimental protocols. Children were assigned a unique ID number and the data did not include their names or addresses. We created a polygenic risk score (PRS) comprising 28 common obesity-related single-nucleotide polymorphisms that had been identified in a meta-analysis of obesity-related genome-wide association studies. The primary outcome was the association between the PRS, adiposity, and satiety responsiveness.

We analysed existing genetic data from children, which we collected during a population-based twin birth cohort ("genetic data").

Subclinical hypothyroidism is a common condition (81,8%) among older men and women. Thyroid hormone affects many physiological systems, including the vascular tree, heart, skeletal muscle, and brain. Thyroxin is substituted to overcome thyroid hormone deficiency, and may offer multisystem benefits to older people with subclinical hypothyroidism. This multicentre randomised placebo controlled trial aimed to assess the effects of thyroxin replacement in older adults who have persistent subclinical hypothyroidism.

Men aged ≥65 years, who suffered from subclinical hypothyroidism, were randomized to either a thyroxin (Eltroxin-LF®) starting dose of 50 μg daily p.o. (reduced to 25 μg daily in subjects <50 kg body weight, or if known coronary heart disease) or a matching placebo p.o. Eltroxin-LF®. (The manufacturer of Eltroxin-LF® provided placebo tablets that looked identical.) Subjects were reviewed face-to-face by study nurses at recruitment, study baseline, 6-8 weeks after baseline, after each dose change, 12 months, and annually thereafter. Study nurses made interim telephone contact at 6, 18, 30, and 42 months; possible cardiovascular and serious adverse events were recorded. The primary outcome included fatal and non-fatal cardiovascular events (fatal and non-fatal acute myocardial infarction and stroke; amputations for peripheral vascular disease; revascularisations for atherosclerotic vascular disease, including for acute coronary syndrome; heart failure hospitalisations).

The investigator randomly allocated ("prospectively assigned") men ("persons") who suffered from subclinical hypothyroidism to receive either thyroxin (Eltroxin-LF®) or placebo ("health-related intervention (therapeutic measure)"). The purpose of the study was to compare the number of fatal and non-fatal cardiovascular events ("to investigate its effect on health").

Migraine and other acute primary headaches are treated with a variety of parenteral medications in the emergency department. It is not clear which medication is best to prescribe to primary headache patients when they are discharged. This study compared the efficacy of oral sumatriptan to naproxen for treatment of post-ED recurrent primary headache.

Adults aged 18 years or older who suffered from headache recurrence after discharge from an emergency department were randomized to either naproxen (Trade®) 500 mg or sumatriptan (Sumatriptan Spirig HC®) 100 mg. This was an open trial: patients and physicians knew who was given which medication. Both products were provided in the original package. The packages had trial-specific labels and were handed out by a hospital pharmacist. Patients were followed-up by telephone 48 hours after emergency department discharge. The primary outcome was change in pain intensity, measured during a two-hour period after ingestion. The change in the group that received 500 mg naproxen (Trade®) was compared to the change in the group that received 100 mg sumatriptan (Sumatriptan Spirig HC®). This difference was measured on a validated 11-point (0–10) verbal Numerical Rating Scale (NRS).

In this research project, the investigator randomly assigned ("prospectively assigned") adults ("persons") who suffered from headache after discharge from an emergency department to receive either 500 mg naproxen (Trade®) or 100 mg sumatriptan (Sumatriptan Spirig HC®) ("health related intervention (therapeutic measure)"). The project assessed between-group difference in change in in pain intensity over the 2-hour period after they took the drugs ("to investigate its effect on health").

Venous thromboembolism is common and significantly increases morbidity, mortality, and costs of care. Although most patients with venous thromboembolism are ≥65 years, there is little data on medical outcomes in older patients. We conducted a prospective multicentre cohort study of in- and outpatients ≥65 years, who have acute venous thromboembolism. All five Swiss university and four high-volume non-university hospitals participate in the study. Their goal is to determine the clinical and biological factors and processes of care that drive short- and long-term medical outcomes, health-related quality of life, and use of medical resources in elderly patients with acute venous thromboembolism.

Elderly patients (≥65 years) with venous thromboembolism were enrolled in the cohort. We followed-up participants from October, 2012, to December, 2013. Follow-up included a telephone interview, two surveillance face-to-face evaluations during the first year, semi-annual contacts, and periodic review of patients' hospital charts. We collected blood samples from all participants at baseline and at 12 months follow-up and established a biobank. We extracted serum, plasma RNA and DNA from the blood. Blood samples were assayed with a standard haematology panel. They were processed and vialed within 1 h of collection and transported in batches to a central laboratory where they were stored at -80°C. The same laboratory analysed all the samples we collected. The primary medical outcome was recurrence of symptomatic, objectively confirmed venous thromboembolism during the follow-up period, defined as new or recurrent pulmonary embolism or deep vein thrombosis (proximal and/or distal).

Researchers used telephone interviews, clinical exams and face-to-face visits to follow up adults ("persons") who suffered from venous thromboembolism. Researchers established a biobank with the blood samples they collected from all participants at enrolment and at 12 months. The study determined the recurrence of symptomatic, objectively confirmed venous thromboembolism during the follow-up period, defined as new or recurrent pulmonary embolism or deep vein thrombosis (proximal and/or distal). This project involved no health-related interventions (according to OClin).

In literature there is general consensus that using a mirror improves proprioception. During rehabilitation, a mirror is very useful for improving stability. In some sports, such as dancing, mirrors are widely used in training. This study evaluated the effectiveness of physiotherapy with mirror on balance in young dancers.

This study included young dancers (aged 19-25) suffering from chronic knee pain. They were randomly assigned to receive physiotherapy, one to one, with a mirror (mirror- group) or without a mirror (non-mirror group). Their balance was evaluated by BESS (Balance Error Scoring System), which consists of three stances (double limb, single limb, and tandem) on two surfaces (firm and foam). Errors were assessed at each stance and summed to create the two subtotal scores (firm and foam surface) and the final total score (BESS). The BESS was measured at recruitment (T0) and again after 6 months of dance lessons (T1). Primary outcome was difference in total BESS between the groups.

The investigator randomly assigned ("prospectively assigned") female dancers suffering from chronic knee pain to receive physiotherapy either with or without a mirror. The study assessed between-groups difference via the Balance Error Scoring System ("to investigate its effect on health"). The purpose was to increase our understanding of the use of mirrors during rehabilitation, as a tool to improve stability ("therapeutic measure").

This study investigated the effectiveness of a school-based intervention to increase physical activity, reduce sedentary behaviour, and increase children’s consumption of fruit and vegetables.

Participants were children in school year 4 (age 8-9 years) at recruitment and baseline assessment, and in year 5 during the intervention and follow-up assessments. Schools were randomly allocated to receive either the Active for Life intervention or standard teaching. The Active for Life intervention provided teacher training, lessons, and child-parent interactive homework plans, the materials required for lessons and homework, and written materials for school newsletters and parents. Schools in the control group received standard teaching. Pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day, accelerometer assessed minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables.

The investigator randomly assigned ("prospectively assigned") primary schools to receive either standard teaching or the Active for Life intervention to increase physical activity, reduce sedentary behaviour, and increase children’s consumption of fruit and vegetables. The study assessed the between-group difference in minutes of moderate to vigorous physical activity per day, minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables ("to investigate its effect on health").

Dyslipidaemia, characterized by raised triglyceride and low-density lipoprotein cholesterol and reduced high-density lipoprotein cholesterol levels, is common in HIV-infected individuals. Dyslipidaemia has been associated with HIV infection and antiretroviral therapy. This study evaluated the frequency with which the replacement of Lopinavir/Ritonavir, Atazanavir/Nitonavir, Darunavir/Ritonavir or Efavirenz by Etravirin (Intelence®) in dyslipidemic patients with suppressed viremia made it unnecessary to administer statins.

The study included HIV-infected patients, aged 18-70 years, on statin treatment for at least 3 months, and on a stable (> 3 months) antiretroviral therapy treatment that included at least one of the following drugs: Lopinavir/Ritonavir, Atazanavir/Nitonavir, Darunavir/Ritonavir or Efavirenz. Statin treatment of dyslipidemic HIV patients on antiretroviral drugs was interrupted during 4 weeks. At week 4, patients who qualified for a lipid lowering drug (calculated LDL-C≥ 3mmol/L) replaced lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir or efavirenz with Etravirine (Intelence®), 400 mg/day, once daily. The primary outcome was the proportion of patients that no longer qualified for statin treatment at 12 weeks (after 8 weeks of Etravirine treatment).

The investigator asked HIV infected adults on statin treatment for at least 3 months, and on a stable antiretroviral therapy treatment, to interrupt their statin treatment for 4 weeks. At week 4, patients who qualified for a lipid lowering drug replaced their antiretroviral treatment with Etravirine (Intelence®), 400 mg/day, once daily ("prospectively assigned"). The study assessed the proportion of patients who no longer qualified for statin treatment after 8 weeks of Etravirine (Intelence®) treatment ("to investigate its effects on health or on the structure and function of the human body").

This study evaluated the test characteristics of clinical examinations of paediatric patients, supplemented with bedside emergency ultrasound, and compared them to clinical examination alone, to identify skin and soft tissue infections that require drainage. The ultrasound device bears a CE mark, but is not used as intended. Since the bedside emergency ultrasound was added to clinical practice and the investigation of the clinical performance of adding bedside ultrasound was the goal of the study, the study qualifies as a clinical trial (and not as an observational study according to HRO chapter 2). - The study is conducted by an academic sponsor, who does not intend to use the data generated in the study to establish or demonstrate the conformity of the device for the new purpose investigated in the study.

This was a prospective study of clinical examinations, supplemented with bedside emergency ultrasound, as a diagnostic test to evaluate patients 2 months to 19 years old. These patients were evaluated for skin and soft tissue infections in a paediatric emergency department. Each patient was clinically examined by the responsible physician (standard) and by an independent radiologist, who performed a bedside emergency ultrasound (result not communicated to the responsible physician). The reference standard that determined if a lesion required drainage was defined as "pus expressed at the time of the emergency department visit or within 2 days by follow-up assessment". The primary outcome was the degree of agreement between clinical exam alone, and clinical exam supplemented with ultrasound, on the number of lesions that required drainage within 2 weeks after clinical examination. No other study-related procedures were performed except for the ultrasound.

The performance of an ultrasound device (“medical device”) was systematically tested in children ("persons") aged 2 months to 19 years, who suffered from skin and soft tissue lesions. The goal was to examine how consistent two examination techniques were in diagnosing lesions that require drainage.

Obesity is highly heritable, and researchers are identifying the specific genes involved. Discovering the mechanisms through which obesity-related genes influence weight will help pinpoint novel targets for intervention. This study tested the hypothesis that satiety responsiveness is an intermediate behavioural phenotype associated with genetic predisposition to obesity in children.

We used genetic data that was collected previously in a population-based twin birth cohort, with twins born in 1996 (National Twins Cohort). In the original cohort study children made up the cohort; one child was randomly selected from each twin pair. Buccal swabs were used to extract DNA. Genome-wide genotyping was done with SNP array, using standard experimental protocols. Children were assigned a unique ID number and the data did not include their names or addresses. We created a polygenic risk score (PRS) comprising 28 common obesity-related single-nucleotide polymorphisms that had been identified in a meta-analysis of obesity-related genome-wide association studies. The primary outcome was the association between the PRS, adiposity, and satiety responsiveness.

We analysed existing genetic data from children, which we collected during a population-based twin birth cohort ("genetic data").

Obesity is highly heritable, and researchers are identifying the specific genes involved. Discovering the mechanisms through which obesity-related genes influence weight will help pinpoint novel targets for intervention. This study tested the hypothesis that satiety responsiveness is an intermediate behavioural phenotype associated with genetic predisposition to obesity in children.

We used genetic data that was collected previously in a population-based twin birth cohort, with twins born in 1996 (National Twins Cohort). In the original cohort study children made up the cohort; one child was randomly selected from each twin pair. Buccal swabs were used to extract DNA. Genome-wide genotyping was done with SNP array, using standard experimental protocols. Children were assigned a unique ID number and the data did not include their names or addresses. We created a polygenic risk score (PRS) comprising 28 common obesity-related single-nucleotide polymorphisms that had been identified in a meta-analysis of obesity-related genome-wide association studies. The primary outcome was the association between the PRS, adiposity, and satiety responsiveness.

We analysed existing genetic data from children, which we collected during a population-based twin birth cohort ("genetic data"). Children were assigned a unique ID number ("existing encoded genetic data") and the data did not include their names or addresses.

This study determined the prevalence and characteristics of employed adults with depression, who attended an external employee assistance program.

We obtained data from 9,105 of 10,794 employees suffering from depression who self-referred to an external employee assistance program. The data manager of the assistance program, who was not involved in our project, prepared and provided us with the data. Employees attending the assistance program were coded using a unique identifying number. Data included employees’ age (but not exact date of birth) and language region. Outcome measures included the self-rated nine-item Patient Health Questionnaire (PHQ-9), filled out routinely prior the first counselling visit as part of the assistance program.

Researchers analysed existing data from employed adults who suffered from a first episode of depression and who self-referred to an external employee assistance program. The assistance program collected the data for purposes other than our research project (it was routinely collected in the standard assistance program ["existing health-related data"]).

This study determined the prevalence and characteristics of employed adults with depression, who attended an external employee assistance program.

We obtained data from 9,105 of 10,794 employees suffering from depression who self-referred to an external employee assistance program. The data manager of the assistance program, who was not involved in our project, prepared and provided us with the data. Employees attending the assistance program were coded using a unique identifying number. Data included employees’ age (but not exact date of birth) and language region. Outcome measures included the self-rated nine-item Patient Health Questionnaire (PHQ-9), filled out routinely prior the first counselling visit as part of the assistance program.

Researchers analysed existing data from employed adults who suffered from a first episode of depression and who self-referred to an external employee assistance program ("existing health-related data"). Participants’ names or other identifying information were not included in the data. Participants were coded with a unique identifying number ("encoded non-genetic data"). The key that linked a subject’s unique identifying number with their personal data was held by the data manager of the assistance program, who was not involved in the research project.

Needle thoracotomy is an emergent procedure designed to relieve tension pneumothorax. The procedure often fails because the needle does not penetrate into the thoracic cavity. Advanced Trauma Life Support guidelines recommend placement in the second intercostal space, midclavicular line, using a 5-cm needle. This study was evaluated placement in the fifth intercostal space, midaxillary line, where tube thoracotomy is routinely performed.

Twenty unpreserved adult cadavers were evaluated. A standard 14-gauge 5-cm needle was placed in both the fifth intercostal space at the midaxillary line and the traditional second intercostal space at the midclavicular line, in both the right and left chest walls. The needles were secured and thoracotomy was then performed to assess penetration into the pleural cavity. The rate of successful needle placement between fifth intercostal space at the midaxillary line, and the traditional second intercostal space at the midclavicular line on the right and left sites, was compared.

Unpreserved adult cadavers ("deceased persons") were used in this research project.

This study investigated whether rituximab, a drug commonly prescribed to patients with rheumatoid arthritis or inflammatory myositis, was associated with subclinical interstitial lung disease. We measured surrogate markers (by spirometry) of interstitial lung disease before, during and after treatment with rituximab, in patients with rheumatoid arthritis or inflammatory myositis for whom a de novo rituximab treatment was indicated.

Subjects aged ≥18 years with established diagnosis of rheumatoid arthritis or inflammatory myositis, for whom a de novo rituximab treatment was indicated, were evaluated by spirometry for surrogate markers of interstitial lung disease (forced vital capacity and diffusing capacity of the lung for carbon monoxide). We measured surrogate markers (by spirometry) immediately before initiation of rituximab therapy and 2, 4, 8 weeks and 6 months after initiation of rituximab therapy. We defined a reduction in forced vital capacity of ≥10% or a fall of ≥15% in diffusing capacity of the lung for carbon monoxide as indicative for subclinical interstitial lung disease. The primary outcome was the rate of interstitial lung disease 6 months after treatment with rituximab.

Spirometry is a common test that measures body function. It is non-invasive test; patients blow into a tube. Spirometry poses minimal risk to patients.

Femoroacetabular impingement may cause early osteoarthritis (OA) in the non-dysplastic hip. This study determined the prevalence of both femoral and acetabular types of impingement in young females.

We conducted a population-based cross-sectional study of asymptomatic young females. All participants completed a set of questionnaires and had their hips clinically examined. A random sample of women was subsequently invited for contrast enhanced magnetic resonance images (MRI) of the hip (contrast media injected intra-articularly). MRIs were read to detect cam-type deformities, increased acetabular depths, labral lesions, and impingement pits. We estimated the prevalence of cam-type deformities and increased acetabular depth, and the relationships between deformities and signs of joint damage.

Healthy women completed a questionnaire and had their hips clinically examined. We used magnetic resonance images (MRI) of the hip and contrast agent to determine the prevalence of cam-type deformities in a random sample of participants. Magnetic resonance image and contrast agent are invasive procedures and are more than minimally risky and burdensome for participants.

Patients receiving a coronary stent during a percutaneous corornary intervention need to take dual antiplatelet therapy after the procedure. The aim of the antiplatelet therapy is to prevent patients from stent-related blood clots and other major adverse cardiovascular events following the implantation. Dual antiplatelet therapy consists of regular intake of oral aspirin and a second anti clotting drug. The aim of the study was to evaulate the optimal duration of such a dual antiplatelet therapy.

Patients undergoing stent placement for the treatment of coronary artery lesions were randomized to receive a prescription for clopidogrel for 12 months or 24 months. In addition, all patients received a prescription for aspirin life-long. Patients were responsible to obtain the prescribed treatment with the prescription at their local pharmacy. Randomized prescriptions specified the International Nonproprietary Name (INN) and therefore left the descision on which specific preparation (proprietary medicinal product) to be handed to the patient at the discretion of the pharmacist. Patients were assessed every 6 months. Patients in the 12-month arm were reminded to stop treatment of clopidogrel at the 12-month visit and patients in the 24-month arm at the 24-month visit. Patients were followed-up for 5 years. The trial had two primary outcomes: 1) the composite of all-cause death and major cardiovasular events at 24-month follow-up; 2) major bleeding events at 24-month follow-up.

Although the effects of different length of clopidogrel treatment are investigated ("medicinal products") in this clinical trial the allocation actually randomized prescriptions. Drugs were not provided by investigators. The choice of the specific preparation (proprietary medicinal product) was left at the discretion of the pharmacist and not documented. Therefore, the trial took a pragmatic, real-world approach and had no direct control on the actual preparation used.

Those diagnosed with depression are overwhelmed by sadness that lasts for at least two weeks. Other symptoms include changes in appetite or sleep patterns, lack of energy or motivation, and even thoughts of suicide. Those diagnosed with depressions often need medication, therapy, or a combination of the two to relieve their symptoms and regain their normal function. This study sought to determine if behavioural activation therapy (a psychological intervention) was as effective as antidepressant medication (fluoxetine) for adolescents diagnosed with depression.

This study randomly allocated adolescents between 12-16 years old, who met criteria for Major Depressive Disorder, to receive behavioural activation therapy or fluoxetine (Fluoxetin-Mepha®) over the course of 18 weeks. Those randomized to fluoxetine visited their psychiatrist regularly but did not receive psychotherapy. Those who received behavioural activation therapy received between 18-20 one-hour sessions of individual therapy that focused on increasing enjoying and rewarding behaviours. The primary outcome was the difference in mean change of depressive symptoms as measured with the Children's Depression Rating Scale - Revised (CDRS-R).

The effects of behavioural therapy and fluoxetine (Fluoxetin-Mepha®) were investigated (Fluoxetin-Mepha® is a "medicinal product") in this randomised-controlled trial.

Migraine and other acute primary headaches are treated with a variety of parenteral medications in the emergency department. It is not clear which medication is best to prescribe to primary headache patients when they are discharged. This study compared the efficacy of oral sumatriptan to naproxen for treatment of post-ED recurrent primary headache.

Adults aged 18 years or older who suffered from headache recurrence after discharge from an emergency department were randomized to either naproxen (Trade®) 500 mg or sumatriptan (Sumatriptan Spirig HC®) 100 mg. This was an open trial: patients and physicians knew who was given which medication. Both products were provided in the original package. The packages had trial-specific labels and were handed out by a hospital pharmacist. Patients were followed-up by telephone 48 hours after emergency department discharge. The primary outcome was change in pain intensity, measured during a two-hour period after ingestion. The change in the group that received 500 mg naproxen (Trade®) was compared to the change in the group that received 100 mg sumatriptan (Sumatriptan Spirig HC®). This difference was measured on a validated 11-point (0–10) verbal Numerical Rating Scale (NRS).

This clinical trial investigated the effects of naproxen (Trade®) 500 mg and sumatriptan (Sumatriptan Spirig HC®) 100 mg. (Both are "medicinal products").

Drug-eluting coronary artery stents that release therapeutic agents locally, in a controlled fashion, have improved the safety and efficacy of percutaneous coronary interventions. This study compares the safety and efficacy of a sirolimus-eluting stent with a biodegradable polymer with that of an everolimus-eluting stent with a durable polymer. This is a prospective multicentre randomized controlled non-inferiority trial in patients who underwent percutaneous coronary intervention during routine clinical practice.

Subjects aged ≥18 years, who have a symptomatic coronary artery disease (including chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS), are randomized for treatment either with the CE-marked Orsiro® stent system (sirolimus-eluting stent with a biodegradable polymer) or a CE-marked Xience PRIME® stent system (everolimus-eluting stent with a durable polymer). Primary endpoints are target lesion failure (defined as the composite of cardiac death, as well as target vessel myocardial infarction, and clinically driven target-lesion revascularization). No off-label use and no additional invasive or burdensome procedures in addition to those performed under the normal conditions of use of the two devices are described in the study protocol.

The effects of the Orsiro® stent system and the Xience PRIME® stent system were investigated (both "medical devices") in this clinical trial.

This study evaluated the test characteristics of clinical examinations of paediatric patients, supplemented with bedside emergency ultrasound, and compared them to clinical examination alone, to identify skin and soft tissue infections that require drainage. The ultrasound device bears a CE mark, but is not used as intended. Since the bedside emergency ultrasound was added to clinical practice and the investigation of the clinical performance of adding bedside ultrasound was the goal of the study, the study qualifies as a clinical trial (and not as an observational study according to HRO chapter 2). - The study is conducted by an academic sponsor, who does not intend to use the data generated in the study to establish or demonstrate the conformity of the device for the new purpose investigated in the study.

This was a prospective study of clinical examinations, supplemented with bedside emergency ultrasound, as a diagnostic test to evaluate patients 2 months to 19 years old. These patients were evaluated for skin and soft tissue infections in a paediatric emergency department. Each patient was clinically examined by the responsible physician (standard) and by an independent radiologist, who performed a bedside emergency ultrasound (result not communicated to the responsible physician). The reference standard that determined if a lesion required drainage was defined as "pus expressed at the time of the emergency department visit or within 2 days by follow-up assessment". The primary outcome was the degree of agreement between clinical exam alone, and clinical exam supplemented with ultrasound, on the number of lesions that required drainage within 2 weeks after clinical examination. No other study-related procedures were performed except for the ultrasound.

The performance of an ultrasound device (“medical device”) was systematically tested in children ("persons").

Patients receiving a coronary stent during a percutaneous corornary intervention need to take dual antiplatelet therapy after the procedure. The aim of the antiplatelet therapy is to prevent patients from stent-related blood clots and other major adverse cardiovascular events following the implantation. Dual antiplatelet therapy consists of regular intake of oral aspirin and a second anti clotting drug. The aim of the study was to evaulate the optimal duration of such a dual antiplatelet therapy.

Patients undergoing stent placement for the treatment of coronary artery lesions were randomized to receive a prescription for clopidogrel for 12 months or 24 months. In addition, all patients received a prescription for aspirin life-long. Patients were responsible to obtain the prescribed treatment with the prescription at their local pharmacy. Randomized prescriptions specified the International Nonproprietary Name (INN) and therefore left the descision on which specific preparation (proprietary medicinal product) to be handed to the patient at the discretion of the pharmacist. Patients were assessed every 6 months. Patients in the 12-month arm were reminded to stop treatment of clopidogrel at the 12-month visit and patients in the 24-month arm at the 24-month visit. Patients were followed-up for 5 years. The trial had two primary outcomes: 1) the composite of all-cause death and major cardiovasular events at 24-month follow-up; 2) major bleeding events at 24-month follow-up.

Although the effects of different length of clopidogrel treatment are investigated ("medicinal products") in this clinical trial the allocation actually randomized prescriptions. Drugs were not provided by investigators. The choice of the specific preparation (proprietary medicinal product) was left at the discretion of the pharmacist and not documented. Therefore, the trial took a pragmatic, real-world approach and had no direct control on the actual preparation used.

Those diagnosed with depression are overwhelmed by sadness that lasts for at least two weeks. Other symptoms include changes in appetite or sleep patterns, lack of energy or motivation, and even thoughts of suicide. Those diagnosed with depressions often need medication, therapy, or a combination of the two to relieve their symptoms and regain their normal function. This study sought to determine if behavioural activation therapy (a psychological intervention) was as effective as antidepressant medication (fluoxetine) for adolescents diagnosed with depression.

This study randomly allocated adolescents between 12-16 years old, who met criteria for Major Depressive Disorder, to receive behavioural activation therapy or fluoxetine (Fluoxetin-Mepha®) over the course of 18 weeks. Those randomized to fluoxetine visited their psychiatrist regularly but did not receive psychotherapy. Those who received behavioural activation therapy received between 18-20 one-hour sessions of individual therapy that focused on increasing enjoying and rewarding behaviours. The primary outcome was the difference in mean change of depressive symptoms as measured with the Children's Depression Rating Scale - Revised (CDRS-R).

The effects of behavioural therapy and fluoxetine (Fluoxetin-Mepha®) were investigated (Fluoxetin-Mepha® is a "medicinal product") in this randomised-controlled trial. Behavioural therapy (psychotherapy) is not a medicinal product/device, a transplant or transplant product, a gene therapy, or a pathogenic organism.

This study investigated the effectiveness of a school-based intervention to increase physical activity, reduce sedentary behaviour, and increase children’s consumption of fruit and vegetables.

Participants were children in school year 4 (age 8-9 years) at recruitment and baseline assessment, and in year 5 during the intervention and follow-up assessments. Schools were randomly allocated to receive either the Active for Life intervention or standard teaching. The Active for Life intervention provided teacher training, lessons, and child-parent interactive homework plans, the materials required for lessons and homework, and written materials for school newsletters and parents. Schools in the control group received standard teaching. Pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day, accelerometer assessed minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables.

The study asked if the Active for Life intervention increased physical activity, reduced sedentary behaviour, and increased children’s fruit and vegetable more than standard teaching did. A teaching intervention is not a medicinal product or device, a transplant or transplant product, a gene therapy, or a pathogenic organism.

Most urinary tract infections are uncomplicated. The disease is benign and self-limited, and the primary goal of treatment is symptom relief rather than cure. The study was designed to determine if initial symptomatic treatment, followed by optional delayed antibiotic treatment, was non-inferior to immediate antibiotic treatment, followed by optional delayed antibiotic treatment, in resolving symptoms.

Women 18-70 years old, who had acute uncomplicated urinary tract infections, were randomly allocated to receive symptomatic treatment (diclofenac [Olfen®] 75 mg twice daily, followed by optional, delayed antibiotic treatment with a single dose of 3 g fosfomycin, if the patient thought it was necessary) or to receive immediate antibiotic treatment (norfloxacin [Norfloxacin-Teva®] 400 mg twice daily, for three days, followed by optional, delayed antibiotic treatment with single dose of 3 g fosfomycin if the patient thought it was necessary). To ensure blinding, Olfen® and Norfloxacin-Teva® were encapsulated in a GMP-facility by a pharmacist. Patients kept a diary for 10 days, in which they described symptoms. The researchers followed up with a telephone interview on days 10 and 30. The primary outcome of the trial was the proportion of patients whose symptoms resolved on day 4.

This randomized-controlled, double-blind trial investigated the effects of diclofenac (Olfen®) and norfloxacin (Norfloxacin-Teva®), which are "medicinal products"). Both are "authorised" for the Swiss market (approval number for Olfen®: 55164 (Swissmedic) and Norfloxacin-Teva®: 55602 (Swissmedic)).

This study compared the efficacy of secukinumab to ustekinumab (Stelara®) in patients that have plaque-type psoriasis.

Adults, aged 18 or older, who suffered from moderate to severe plaque type psoriasis for at least 6 months before randomization, were randomly allocated to receive secukinumab 300 mg once every weeks (at weeks 0, 1, 2, 3), followed by monthly dosing starting at week 4 and continuing through week 48, or to receive ustekinumab (Stelara®) 45mg once a week (at weeks 0, 4, 8 and 12). Severity and extent of psoriasis was measured using the PASI score (Psoriasis Area and Severity Index). Primary outcome was the difference in the proportion of PASI 90 responders after 16 weeks.

The effects of secukinumab and ustekinumab (Stelara®) were investigated in this clinical trial. Ustekinumab (Stelara®) is "authorised" for the Swiss market (approval number Stelara®: 61267 [Swissmedic]). However, secukinumab does not have a marketing authorisation in Switzerland.

Migraine and other acute primary headaches are treated with a variety of parenteral medications in the emergency department. It is not clear which medication is best to prescribe to primary headache patients when they are discharged. This study compared the efficacy of oral sumatriptan to naproxen for treatment of post-ED recurrent primary headache.

Adults aged 18 years or older who suffered from headache recurrence after discharge from an emergency department were randomized to either naproxen (Trade®) 500 mg or sumatriptan (Sumatriptan Spirig HC®) 100 mg. This was an open trial: patients and physicians knew who was given which medication. Both products were provided in the original package. The packages had trial-specific labels and were handed out by a hospital pharmacist. Patients were followed-up by telephone 48 hours after emergency department discharge. The primary outcome was change in pain intensity, measured during a two-hour period after ingestion. The change in the group that received 500 mg naproxen (Trade®) was compared to the change in the group that received 100 mg sumatriptan (Sumatriptan Spirig HC®). This difference was measured on a validated 11-point (0–10) verbal Numerical Rating Scale (NRS).

This clinical trial investigated the effects of naproxen (Trade®) 500 mg and sumatriptan (Sumatriptan Spirig HC®) 100 mg. Both are “authorised” for the market in Switzerland, and are provided “as is”, unchanged except for their labels. (Approval numbers for sumatriptan/[Sumatriptan Spirig HC®]: 58466, 58512, 58513 [Swissmedic]; and, for naproxen/[Trade®]: 51480 [Swissmedic]).

The androgen receptor inhibitor enzalutamide (Xtandi®) was approved to treat metastatic castration-resistant prostate cancer that has progressed on docetaxel. This study assessed the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer.

Men at least 18 years old, with hormone-naive prostate cancer, for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide (Xtandi®) 160 mg/day. The primary outcome, measured at week 25, was the proportion of patients in whom a prostate-specific antigen had declined 80% or more.

This clinical trial investigated the effects of enzalutamide (Xtandi®) 160 mg/day. Xtandi® is “authorised” for the market in Switzerland, and is provided “as is”. The medicinal product was provided in its original package but labelled with a trial-specific sticker (label). However, the label did not cover any pharmaceutically relevant information.

Most urinary tract infections are uncomplicated. The disease is benign and self-limited, and the primary goal of treatment is symptom relief rather than cure. The study was designed to determine if initial symptomatic treatment, followed by optional delayed antibiotic treatment, was non-inferior to immediate antibiotic treatment, followed by optional delayed antibiotic treatment, in resolving symptoms.

Women 18-70 years old, who had acute uncomplicated urinary tract infections, were randomly allocated to receive symptomatic treatment (diclofenac [Olfen®] 75 mg twice daily, followed by optional, delayed antibiotic treatment with a single dose of 3 g fosfomycin, if the patient thought it was necessary) or to receive immediate antibiotic treatment (norfloxacin [Norfloxacin-Teva®] 400 mg twice daily, for three days, followed by optional, delayed antibiotic treatment with single dose of 3 g fosfomycin if the patient thought it was necessary). To ensure blinding, Olfen® and Norfloxacin-Teva® were encapsulated in a GMP-facility by a pharmacist. Patients kept a diary for 10 days, in which they described symptoms. The researchers followed up with a telephone interview on days 10 and 30. The primary outcome of the trial was the proportion of patients whose symptoms resolved on day 4.

This randomized-controlled, double-blind trial investigated the effects of diclofenac (Olfen®) and norfloxacin (Norfloxacin-Teva®), which are "medicinal products"). Both are "authorised" for the Swiss market. Neither product was provided in the original state (authorised), but were encapsulated instead.

Subclinical hypothyroidism is a common condition (81,8%) among older men and women. Thyroid hormone affects many physiological systems, including the vascular tree, heart, skeletal muscle, and brain. Thyroxin is substituted to overcome thyroid hormone deficiency, and may offer multisystem benefits to older people with subclinical hypothyroidism. This multicentre randomised placebo controlled trial aimed to assess the effects of thyroxin replacement in older adults who have persistent subclinical hypothyroidism.

Men aged ≥65 years, who suffered from subclinical hypothyroidism, were randomized to either a thyroxin (Eltroxin-LF®) starting dose of 50 μg daily p.o. (reduced to 25 μg daily in subjects <50 kg body weight, or if known coronary heart disease) or a matching placebo p.o. Eltroxin-LF®. (The manufacturer of Eltroxin-LF® provided placebo tablets that looked identical.) Subjects were reviewed face-to-face by study nurses at recruitment, study baseline, 6-8 weeks after baseline, after each dose change, 12 months, and annually thereafter. Study nurses made interim telephone contact at 6, 18, 30, and 42 months; possible cardiovascular and serious adverse events were recorded. The primary outcome included fatal and non-fatal cardiovascular events (fatal and non-fatal acute myocardial infarction and stroke; amputations for peripheral vascular disease; revascularisations for atherosclerotic vascular disease, including for acute coronary syndrome; heart failure hospitalisations).

The effects of thyroxin (Eltroxin-LF®) and placebo were investigated in this clinical trial. Eltroxin-LF® is "authorised" for the Swiss market. The placebo was manufactured specifically for this research project. Aspects related to good manufacturing practice need to be checked by Swissmedic.

Migraine and other acute primary headaches are treated with a variety of parenteral medications in the emergency department. It is not clear which medication is best to prescribe to primary headache patients when they are discharged. This study compared the efficacy of oral sumatriptan to naproxen for treatment of post-ED recurrent primary headache.

Adults aged 18 years or older who suffered from headache recurrence after discharge from an emergency department were randomized to either naproxen (Trade®) 500 mg or sumatriptan (Sumatriptan Spirig HC®) 100 mg. This was an open trial: patients and physicians knew who was given which medication. Both products were provided in the original package. The packages had trial-specific labels and were handed out by a hospital pharmacist. Patients were followed-up by telephone 48 hours after emergency department discharge. The primary outcome was change in pain intensity, measured during a two-hour period after ingestion. The change in the group that received 500 mg naproxen (Trade®) was compared to the change in the group that received 100 mg sumatriptan (Sumatriptan Spirig HC®). This difference was measured on a validated 11-point (0–10) verbal Numerical Rating Scale (NRS).

This clinical trial investigated the effects of naproxen (Trade®) 500 mg and sumatriptan (Sumatriptan Spirig HC®) 100 mg. Both are “authorised” for the market in Switzerland, and are provided “as is”. The medicinal product was provided in its original package but labelled with a trial-specific sticker (label). However, the label did not cover any pharmaceutically relevant information. This modification is not manufactering according to the Therapeutics Product Act (TPA).

The androgen receptor inhibitor enzalutamide (Xtandi®) was approved to treat metastatic castration-resistant prostate cancer that has progressed on docetaxel. This study assessed the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer.

Men at least 18 years old, with hormone-naive prostate cancer, for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide (Xtandi®) 160 mg/day. The primary outcome, measured at week 25, was the proportion of patients in whom a prostate-specific antigen had declined 80% or more.

This clinical trial investigated the effects of enzalutamide (Xtandi®) 160 mg/day in men aged 18 or older with hormone-naive prostate cancer, for whom hormone therapy was indicated and who had non-castration levels of testosterone. Enzalutamide (Xtandi®) was not given in combination with hormone therapy. Enzalutamide (Xtandi®) is approved in combination with luteinising hormone-releasing hormone analogues to treat patients with metastatic castration-resistant prostate cancer, who already received docetaxel therapy. Use of enzalutamide (Xtandi®) within this clinical trial does not correspond with approved uses.

The androgen receptor inhibitor enzalutamide (Xtandi®) was approved to treat metastatic castration-resistant prostate cancer that has progressed on docetaxel. This study assessed the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer.

Men at least 18 years old, with hormone-naive prostate cancer, for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide (Xtandi®) 160 mg/day. The primary outcome, measured at week 25, was the proportion of patients in whom a prostate-specific antigen had declined 80% or more.

This clinical trial investigates the effects of enzalutamide (Xtandi®) 160 mg/day in men aged 18 or older with hormone-naive prostate cancer, for whom hormone therapy was indicated and who had non-castration levels of testosterone. Xtandi® is approved in combination with luteinising hormone-releasing hormone analogues to treat patients with metastatic castration-resistant prostate cancer, who have already received docetaxel therapy. Hormone-naive prostate cancer falls within the same ICD-10 group as the approved indication (metastatic castration-resistant prostate cancer, for those who have previously received docetaxel therapy C61: Malignant neoplasm of prostate).

The androgen receptor inhibitor enzalutamide (Xtandi®) was approved to treat metastatic castration-resistant prostate cancer that has progressed on docetaxel. This study assessed the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer.

Men at least 18 years old, with hormone-naive prostate cancer, for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide (Xtandi®) 160 mg/day. The primary outcome, measured at week 25, was the proportion of patients in whom a prostate-specific antigen had declined 80% or more.

This clinical trial investigates the effects of enzalutamide (Xtandi®) 160 mg/day in men aged 18 or older with hormone-naive prostate cancer, for whom hormone therapy was indicated and who had non-castration levels of testosterone. Self-limiting diseases resolve spontaneously, with or without treatment. Untreated hormone-naive prostate cancer does not resolve spontaneously.

Those diagnosed with depression are overwhelmed by sadness that lasts for at least two weeks. Other symptoms include changes in appetite or sleep patterns, lack of energy or motivation, and even thoughts of suicide. Those diagnosed with depressions often need medication, therapy, or a combination of the two to relieve their symptoms and regain their normal function. This study sought to determine if behavioural activation therapy (a psychological intervention) was as effective as antidepressant medication (fluoxetine) for adolescents diagnosed with depression.

This study randomly allocated adolescents between 12-16 years old, who met criteria for Major Depressive Disorder, to receive behavioural activation therapy or fluoxetine (Fluoxetin-Mepha®) over the course of 18 weeks. Those randomized to fluoxetine visited their psychiatrist regularly but did not receive psychotherapy. Those who received behavioural activation therapy received between 18-20 one-hour sessions of individual therapy that focused on increasing enjoying and rewarding behaviours. The primary outcome was the difference in mean change of depressive symptoms as measured with the Children's Depression Rating Scale - Revised (CDRS-R).

The effects of behavioural therapy and fluoxetine (Fluoxetin-Mepha®) were investigated in this randomized-controlled trial, which included adolescents between 12-16 years old, who suffered from major depressive disorder. A self-limiting disease is one that resolves spontaneously, with or without specific treatment. Major depression disorder is not considered a self-limiting disease. (The estimated remission rate of untreated major depression within 12 months is about 50%, though the rates may be higher in adolescents [Whiteford HA et al. Psychol Med 2013; 43: 1569-85]).

The androgen receptor inhibitor enzalutamide (Xtandi®) was approved to treat metastatic castration-resistant prostate cancer that has progressed on docetaxel. This study assessed the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer.

Men at least 18 years old, with hormone-naive prostate cancer, for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide (Xtandi®) 160 mg/day. The primary outcome, measured at week 25, was the proportion of patients in whom a prostate-specific antigen had declined 80% or more.

This clinical trial investigates the effects of enzalutamide (Xtandi®) 160 mg/day in men aged 18 or older with hormone-naive prostate cancer, for whom hormone therapy was indicated and who had non-castration levels of testosterone. Xtandi® was not be given in combination with hormone therapy. Thus it does not comply with the intended use recommended by the European Association of Urology guidelines on prostate cancer (treatment guideline developed in accordance with international quality criteria).

Those diagnosed with depression are overwhelmed by sadness that lasts for at least two weeks. Other symptoms include changes in appetite or sleep patterns, lack of energy or motivation, and even thoughts of suicide. Those diagnosed with depressions often need medication, therapy, or a combination of the two to relieve their symptoms and regain their normal function. This study sought to determine if behavioural activation therapy (a psychological intervention) was as effective as antidepressant medication (fluoxetine) for adolescents diagnosed with depression.

This study randomly allocated adolescents between 12-16 years old, who met criteria for Major Depressive Disorder, to receive behavioural activation therapy or fluoxetine (Fluoxetin-Mepha®) over the course of 18 weeks. Those randomized to fluoxetine visited their psychiatrist regularly but did not receive psychotherapy. Those who received behavioural activation therapy received between 18-20 one-hour sessions of individual therapy that focused on increasing enjoying and rewarding behaviours. The primary outcome was the difference in mean change of depressive symptoms as measured with the Children's Depression Rating Scale - Revised (CDRS-R).

The effects of behavioural therapy and fluoxetine (Fluoxetin-Mepha®) were investigated in this randomized-controlled trial, which included adolescents between 12-16 years old, who suffered from major depressive disorder. There is no treatment guideline that recommends prescribing antidepressants to this population without also prescribing psychotherapy.

Drug-eluting coronary artery stents that release therapeutic agents locally, in a controlled fashion, have improved the safety and efficacy of percutaneous coronary interventions. This study compares the safety and efficacy of a sirolimus-eluting stent with a biodegradable polymer with that of an everolimus-eluting stent with a durable polymer. This is a prospective multicentre randomized controlled non-inferiority trial in patients who underwent percutaneous coronary intervention during routine clinical practice.

Subjects aged ≥18 years, who have a symptomatic coronary artery disease (including chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS), are randomized for treatment either with the CE-marked Orsiro® stent system (sirolimus-eluting stent with a biodegradable polymer) or a CE-marked Xience PRIME® stent system (everolimus-eluting stent with a durable polymer). Primary endpoints are target lesion failure (defined as the composite of cardiac death, as well as target vessel myocardial infarction, and clinically driven target-lesion revascularization). No off-label use and no additional invasive or burdensome procedures in addition to those performed under the normal conditions of use of the two devices are described in the study protocol.

The effects of the Orsiro® stent system and the Xience PRIME® stent system were investigated in this trial. Both passed the required conformity assessment procedure, and so both stent systems bear a CE mark (conformity mark).

Routine treatment with left ventricular assist devices (LVADs) bridges transplantation for patients with advanced heart failure. We aim to determine the safety and effectiveness of the HeartWare® Ventricular Assist System in patients with chronic advanced stage left ventricular ineligible for cardiac transplantation. The HeartWare® Ventricular Assist System is marketed in several countries, but the use of the System in Switzerland has been prohibited by Swissmedic.

We include patients with advanced heart failure symptoms (Stage D/NYHA Class IIIB or IV, ≥18 years old) who have received and failed optimal medical therapy, and are ineligible for cardiac transplantation. All patients receive the HeartWare® Ventricular Assist System. The primary endpoint of the trial is survival and freedom of re-interventions until cardiac transplantation.

This trial investigated the effects of the HeartWare® Ventricular Assist System ("medical device"). The device passed the required conformity assessment procedure and bears a CE mark.

Routine treatment with left ventricular assist devices (LVADs) bridges transplantation for patients with advanced heart failure. We aim to determine the safety and effectiveness of the HeartWare® Ventricular Assist System in patients with chronic advanced stage left ventricular ineligible for cardiac transplantation. The HeartWare® Ventricular Assist System is marketed in several countries, but the use of the System in Switzerland has been prohibited by Swissmedic.

We include patients with advanced heart failure symptoms (Stage D/NYHA Class IIIB or IV, ≥18 years old) who have received and failed optimal medical therapy, and are ineligible for cardiac transplantation. All patients receive the HeartWare® Ventricular Assist System. The primary endpoint of the trial is survival and freedom of re-interventions until cardiac transplantation.

This trial investigated the effects of the HeartWare® Ventricular Assist System ("medical device"). The device passed the required conformity assessment procedure and bears a CE mark. However, use of the HeartWare® Ventricular Assist System was prohibited in Switzerland during conduct of the trial.

Patients receiving a coronary stent during a percutaneous corornary intervention need to take dual antiplatelet therapy after the procedure. The aim of the antiplatelet therapy is to prevent patients from stent-related blood clots and other major adverse cardiovascular events following the implantation. Dual antiplatelet therapy consists of regular intake of oral aspirin and a second anti clotting drug. The aim of the study was to evaulate the optimal duration of such a dual antiplatelet therapy.

Patients undergoing stent placement for the treatment of coronary artery lesions were randomized to receive a prescription for clopidogrel for 12 months or 24 months. In addition, all patients received a prescription for aspirin life-long. Patients were responsible to obtain the prescribed treatment with the prescription at their local pharmacy. Randomized prescriptions specified the International Nonproprietary Name (INN) and therefore left the descision on which specific preparation (proprietary medicinal product) to be handed to the patient at the discretion of the pharmacist. Patients were assessed every 6 months. Patients in the 12-month arm were reminded to stop treatment of clopidogrel at the 12-month visit and patients in the 24-month arm at the 24-month visit. Patients were followed-up for 5 years. The trial had two primary outcomes: 1) the composite of all-cause death and major cardiovasular events at 24-month follow-up; 2) major bleeding events at 24-month follow-up.

This randomized-controlled, open trial investigates the effects of different lengths of clopidogrel treatment. Clopidogrel is a drug and various proprietary medicinal products are "authorised" for the Swiss market (e.g. approval number for Plavix®: 54509 (Swissmedic)). It is reasonable to assume that pharmacies will only provide authorised products to the patients. All authorised clopidogrel preparations are approved for prevention of atherothrombotic events in patients who received a coronary stent. The recommended dosing schedule is corresponds to dosing schedule in the protocol. Length of treatment is not explicitly mentioned in the package insert but only mentioned as long-term.Therefore, indication and dosage of clopidogrel in this research project corresponds with the approved indication.

This study investigated the effectiveness of a school-based intervention to increase physical activity, reduce sedentary behaviour, and increase children’s consumption of fruit and vegetables.

Participants were children in school year 4 (age 8-9 years) at recruitment and baseline assessment, and in year 5 during the intervention and follow-up assessments. Schools were randomly allocated to receive either the Active for Life intervention or standard teaching. The Active for Life intervention provided teacher training, lessons, and child-parent interactive homework plans, the materials required for lessons and homework, and written materials for school newsletters and parents. Schools in the control group received standard teaching. Pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day, accelerometer assessed minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables.

The study asked if the Active for Life intervention increased physical activity, reduced sedentary behaviour, and increased children’s fruit and vegetable more than standard teaching did. Teaching interventions do not create more than minimal risk or stress to participants.

In literature there is general consensus that using a mirror improves proprioception. During rehabilitation, a mirror is very useful for improving stability. In some sports, such as dancing, mirrors are widely used in training. This study evaluated the effectiveness of physiotherapy with mirror on balance in young dancers.

This study included young dancers (aged 19-25) suffering from chronic knee pain. They were randomly assigned to receive physiotherapy, one to one, with a mirror (mirror- group) or without a mirror (non-mirror group). Their balance was evaluated by BESS (Balance Error Scoring System), which consists of three stances (double limb, single limb, and tandem) on two surfaces (firm and foam). Errors were assessed at each stance and summed to create the two subtotal scores (firm and foam surface) and the final total score (BESS). The BESS was measured at recruitment (T0) and again after 6 months of dance lessons (T1). Primary outcome was difference in total BESS between the groups.

The investigator randomly assigned ("prospectively assigned") female dancers suffering from chronic knee pain to receive physiotherapy either with or without a mirror. The study assessed between-groups difference via the Balance Error Scoring System ("to investigate structure and function on the human body"). Dancing in front of a mirror creates minimal risk or stress in participants.