There are about 13332 clinical studies being (or have been) conducted in Netherlands. 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.
Background of the study: With a prevalence up to 15%, polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. Women with PCOS present with diverse features, including reproductive features such as irregular menstrual cycles, subfertility, hirsutism and pregnancy complications, metabolic features such as obesity, insulin resistance, metabolic syndrome, pre-diabetes, type 2 diabetes and cardiovascular factors, and psychological features such as anxiety and depression. Because of the reproductive, metabolic and cardiovascular risk factors it is important to screen and inform these women. However, up to 70% of the affected women remain undiagnosed. In academic hospitals (tertiary care) the diagnosis PCOS will rarely be missed by gynecologists. However, in peripheral hospitals or for internal medicine physicians, PCOS and its criteria are less well known. Therefore, the PCOS risk algorithm (PriskA), a digital tool to use in the assessment of PCOS in patients with signs and symptoms of PCOS, is developed. To exclude patients with a WHO I status, the tool exclude women with low Luteinizing Hormone (LH) and low Follicle-Stimulating Hormone (FSH) in advance. Women with LH and FSH within the normal range will be used in the algorithm for further assessment. The algorithm uses clinical data including age, BMI and information about irregular menstrual cycle in combination with anti-Mullerian hormone (AMH), testosterone and Sex Hormone Binding Globulin (SHBG) to generate a risk score ranging from 0-1. Women having a risk score below 0.2 are considered having a low risk of having PCOS, women with a risk score 0.2-0.8 are considered having a moderate risk of having PCOS and women with a risk score above 0.8 have a high risk of having PCOS. Objective of the study: In this study we aim to assess the validity of the PriskA algorithm to diagnose PCOS in a pilot study with patients presenting with signs and symptoms of PCOS. The study also aims to collect information on the user experience from the clinicians and to provide useful information to support the design of a validation study. Study design: This study will be a prospective, mono-center observational pilot study and it will be conducted at the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, the Netherlands. We estimate that the study will be completed within one year. Study population: Women with symptoms of PCOS who are referred to the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam, and are undergoing a standardized screening (COLA screening, which stands for: (menstrual) Cycle problems, Oligomenorrhea and Amenorrhea). The COLA screening is part of standard clinical care. Women with one or more symptoms of PCOS will be included in the study. Women who eventually getting the diagnosis PCOS by standard screening will be labelled as cases and women who have one PCOS symptom and did not get the diagnosis PCOS will be labelled as controls. Primary study parameters/outcome of the study: The validity of the PriskA tool to diagnose PCOS, by assessing the sensitivity and specificity of the risk probabilities of 0.2 and 0.8.Parameters that will be used: - Testosterone level in serum (using Elecsys using Cobas 6000) - SHBG level in serum (using Elecsys using Cobas 6000). - AMH level in serum (using Elecsys using Cobas 6000). - LH level in serum (using Elecsys using Cobas 6000) - FSH level in serum (using Elecsys using Cobas 6000) - Cycle information - Age - BMI Secondary study parameters/outcome of the study: A secondary study parameter is to assess the number (percentage) and characteristics of patients with a PriskA score between 0.2-0.8. Characteristics will include: menstrual cycle information, age, BMI, serum LH, serum FSH, serum AMH, serum testosterone, serum SHBG, serum progesterone, serum estradiol, total follicle count, PCOS phenotype (if applicable), WHO diagnosis or other endocrinological diagnosis. Another secondary parameter is the user experience of the PriskA tool. This will be collected from every user by a questionnaire. Questionnaires will be collected from every used when he/she completed 20 patients during the study.
The main objective of the FLAIR-i study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obesity, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo.
There are a lot of parents who believe that their child may not tolerate cow's milk because they develop symptoms such as redness of the skin or they may vomit. It is not always easy to find out if these infants should indeed avoid drinking cow's milk or that the symptoms are caused by something else, for instance because they have a viral illness. The goal of the investigators is to find out if cow's milk should be introduced in the hospital or if it can also be advised to perform the introduction at home to determine if an infant can drink cow's milk without developing symptoms. Half of the participants will drink cow's milk in the hospital. This test is performed on two days. On one of the days cow's milk will be offered. On the other day a look-alike substance is offered. The other half of the participants will drink cow's milk at home by starting to drink a little bit of milk and in a few steps drink a normal bottle of cow's milk. The main question is whether both tests can be used to find out if an infant can drink cow's milk without developing symptoms.
The goal of this multicenter randomized controlled trial is to evaluate the additional value of pre-emptive antibiotic treatment on clinically relevant organ/space surgical site infections (OSIs) in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile. The main objectives it aims to answer are: - To evaluate the effect of pre-emptive antibiotic prophylaxis on clinically relevant OSIs in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile - To evaluate the effect of pre-emptive antibiotic prophylaxis on other postoperative outcomes (e.g. OSIs, superficial SSIs, POPF, PPH, major morbidity, ICU admission, readmission, length of hospital stay, and mortality). - To evaluate concordance between perioperatively obtained bile cultures and postoperative cultures from infectious sites, and to evaluate antibiotic sensitivity patterns of the cultured microorganisms. Participants will be randomized with a 1:1 allocation before surgery into the intervention or control group: - Patients in the intervention group will receive perioperative prophylaxis (similar to the control group) followed by five days of 1500mg IV cefuroxime and 500mg IV metronidazole thrice daily. - Patients in the control group will only receive perioperative prophylaxis (a single dose of 5-7mg/kg gentamicin followed by 2gr IV cefazolin and 500mg IV metronidazole every 4h of surgery), which will be discontinued after surgery.
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
The purpose of this study is to compare AI performance to doctor's performance in the evaluation of IPF/UIP and ILDs without UIP(proven by biopsy).
This study evaluates whether plaques in young patients with familial hypercholesterolemia (aged below 50 years) are susceptible to significant plaque regression with early, intensive lipid lowering therapy.
Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.
Postoperative pain is common, can be severe, has a negative impact on outcomes after surgery and brings along major economic costs for society. A substantial part of patients may develop persistent post-surgical pain. Severity and duration of pain after surgery appear to have a role in this process but the transition from acute postoperative pain to chronic pain is only partially understood. Effective treatment of postoperative pain is hampered by several barriers, including the way measurement of pain and registration of pain-scores are carried out by nurses in clinical practice. Modern technology offers new opportunities for pain measurement and direct patient feedback on postoperative pain, during and also after clinical admission. We developed a smartphone application that allows clinical patients to report pain scores and other pain related outcomes on postoperative pain with their own telephone device. Patient reported pain scores > 3 on a Numeric Rating Scale (NRS) 0-10 are immediately passed on to the nurse who receives a message of the reported pain score. This can lead to earlier detection of pain and a more timely treatment resulting in improved patient reported outcomes on postoperative pain
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.