[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Reinier de Graaf Groep\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100598875","effects-of-permissive-lung-protective-ventilation-on-outcome-in-critically-ill-invasively-ventilated-patients-100598875",false,"NCT07077174","Effects of PERMISSive Lung-protective Ventilation on Outcome in Critically Ill Invasively Ventilated Patients","Effects of PERMISSive Lung-protective Ventilation on Outcome in Critically Ill Invasively Ventilated Patients (PERMISS) - a Feasibility and Safety Pilot Study for a Randomized Clinical Trial","PERMISS pilot","Inclusion Criteria:\n\n* admission to one of the participating ICUs;\n* intubated and receiving invasive ventilation with an expected duration of ventilation of at least 24 hours.\n\nExclusion Criteria:\n\n* age below 18 years;\n* receiving invasive ventilation \\> 1 hour in the ICU, or receiving invasive ventilation \\> 6 hours directly preceding the current ICU admission (i.e., in the operating room or in the emergency department);\n* receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO);\n* having COPD GOLD III and IV;\n* contra-indication for hypercapnia, such as ongoing cardiac ischemia (as defined in the guideline of the European Society of Cardiology), or having suspected or confirmed increased intracranial pressure due to brain injury, judged by the attending physician;\n* any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., Guillain-Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis;\n* suspected or confirmed pregnancy;\n* participation in another interventional trial using similar endpoints;\n* previously randomized in this study;\n* no informed consent; or\n* admitted for terminal care","ALL","18 Years",{"count":20,"type":21},56,"ESTIMATED","INTERVENTIONAL",[24],"NA","RATIONALE Lung-protective ventilation using a lower respiratory rate (RR) is an appealing strategy to reduce ventilation intensity, which may require permissive hypercapnia. However, the feasibility and safety of this so-called 'permissive lung-protective ventilation' must be investigated, before conducting a large randomized clinical trial to evaluate its effectiveness on patient-centered outcomes.\n\nOBJECTIVE To study the feasibility and safety of permissive lung-protective ventilation in adult critically ill patients receiving invasive ventilation for acute hypoxemic respiratory failure, and to inform the design of a future randomized clinical trial in this patient population.\n\nHYPOTHESIS Permissive lung-protective ventilation is a feasible and safe ventilation strategy.\n\nSTUDY DESIGN Multicenter, randomized clinical pilot trial. STUDY POPULATION Critically ill patients, aged \\> 18 years, intubated for acute hypoxemic respiratory failure, and expected to receive ventilation for \\> 24 hours.\n\nMETHODS Patients are randomized to permissive lung-protective ventilation wherein RR is stepwise reduced, or to conventional lung-protective ventilation.\n\nOUTCOME MEASURES The primary endpoint is feasibility, assessed by the difference in respiratory rate (RR) between the two groups, from the start of mechanical ventilation until first extubation. Secondary endpoints include protocol compliance and feasibility of collecting data, and safety, assessed by the occurrence of unacceptable hypercapnia and hypoxemia and the incidence of ventilator-associated complications SAMPLE SIZE To estimate the appropriate sample size for this pilot study, we considered the primary feasibility endpoint of detecting a difference in the respiratory rate (RR). Assuming an expected mean difference in RR of 7.5, based on previous studies \\[1, 2\\], with an SD of 10, a power of 90% and an alpha of 0.05, with a drop-out rate estimated at 10%, a two-tailed t-test was used. The required sample size is 84 patients (42 patients per group).\n\nNATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS Ventilation with a lower RR may require permissive hypercapnia, which, when kept within safe limits, is safe. In current daily practice, there is no guidance in setting RR; consequently, RR varies widely across patients and is often set high. This pilot study compares two forms of lung-protective ventilation, both considered standard care in current ICU practice. The control group receives conventional ventilation with low tidal volumes and high RR to maintain normal PaCO₂ and pH. The intervention group, permissive ventilation, uses a lower RR to reduce mechanical power, accepting mild hypercapnia and acidosis. Permissive ventilation is most often reserved for patients with severe lung conditions, where ventilator settings are more complex and ventilation intensity is high. In these patients, permissive ventilation is considered safe, and may even be beneficial. We aim to evaluate this strategy more broadly in critically ill patients. The collection of demographic, ventilation and outcome data causes no harm to patients. Blood is drawn for arterial blood gas analysis, but this is also part of standard care.",[27,28],"Mechanical Ventilation","Intensive Care (ICU)",[30,31,32,33],"mechanical ventilation","intensive care unit","mechanical power","respiratory rate","RECRUITING","2026-06-19",{"date":37,"type":38},"2026-06-23","ACTUAL",{"date":40,"type":38},"2025-08-31",{"date":42,"type":21},"2026-08-31",{"name":44,"class":45},"Reinier de Graaf Groep","OTHER",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100528517","phase-3-esketamine-as-treatment-for-chronic-pain-due-to-endometriosis-a-rct-study-100528517","NCT06161805","Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study","EASYlight","Inclusion Criteria:\n\n* Women\n* All pre-menopausal women aged above 18 years\n* Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and\u002For diagnostic surgery) according to the #Enzian classification \\[52\\]. This means that endometriosis is present in the following compartments:\n\n  * Rectovaginal space (minimal A1) and\u002For\n  * Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and\u002For\n  * Rectum (minimal C1) and\u002For\n  * Endometriosis of the intestines, diaphragm and\u002For\n  * Adenomyosis (according to the morphological uterus sonographic assessment (MUSA) or evident adenomyosis on the MRI) \\[53, 54\\] and\u002For\n  * Peritoneal \u002F superficial endometriosis (diagnosed laparoscopically and not treated during surgery).\n* Mild to severe chronic pelvic pain (NRS scale \\>= 6). The 11-point NRS scale ranges from '0' representing no pain to '10' representing the worst pain imaginable.\n* Resistant to current recommended lines of analgesics (paracetamol, NSAIDs)\n* Usage of strong opioids must not have been prescribed or otherwise have been discontinued for more than 1 week.\n* An indication for endometriosis resection surgery or on the waiting list for surgical treatment\n* Ability to understand the patient information letter and to give oral and written informed consent\n* No alteration in the utilization of hormonal therapy ≤1 months prior to inclusion.\n\nExclusion Criteria:\n\n* Pain score \\\u003C6 out of 10 (NRS) for chronic pelvic pain\n* Endometriosis affecting the bladder and ureter\n* Increased intracranial pressure\n* Poorly regulated hypertension, \\>180\u002F100mmHg at rest\n* Patients with thyroid disease\n* Patients with cancer\n* History of psychiatric illness (schizophrenia, psychosis, delirium, manic depression)\n* Serious medical disease (e.g., cardiovascular, renal , pulmonary or liver disease)\n* Severe liver disease\n* Patients with glaucoma\n* Usage of strong opioid medication\n* Usage of xanthine derivatives or ergometrine\n* Unstable angina, heart failure, history of cerebral vascular accident (CVA)\n* Patients suffering from an active infection\n* Patients with epilepsy\n* Patients trying to achieve pregnancy and or patients who are breastfeeding\n* Not being able to answer questionnaires (in Dutch)\n* Mentally incompetent (patients not able to make decisions that are in their best interests, this will be evaluated by their treating physician (e.g. patients with an intellectual disability or mental retardation))\n* Alcohol or drug abuse\n* Patient with a known (es)ketamine allergy\n* Abnormal liver enzyme levels at baseline (ASAT, ALAT, GGT, AF, Bilirubin total)\n\nPatients are allowed to continue the following pain medications: paracetamol, non-steroidal anti-inflammatory drugs as described previously by Sigtermans et al. (Trial NL466 (NTR507))\\* according to their stable use in dose and frequency.\n\n\\*in case of tramadol, amitriptylin, selective serotonin reuptake-inhibitors, gabapentin and pregabalin, the usage may also be continued during this study.","FEMALE","50 Years",{"count":20,"type":21},[58],"PHASE3","The goal of this randomized controlled trial is to investigate the effect of esketamine versus placebo on the NRS score for chronic pelvic pain. Secondary endpoints are to assess pain scores, side-effects, quality of life, depressive symptoms and pain coping.",[61,62],"Endometriosis","Chronic Pelvic Pain Syndrome","2025-04-08",{"date":65,"type":38},"2025-04-11",{"date":67,"type":38},"2024-03-01",{"date":69,"type":21},"2026-06-01",{"name":44,"class":45},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":71},"100524269","phase-3-reducing-hot-flashes-in-women-using-endocrine-therapy-100524269","NCT06106529","REDucing Hot FLASHes in Women Using Endocrine Therapy.","A Randomized Intrapatient Cross-over Study to Assess the Efficacy of Oxybutynin Versus Venlafaxine in Reducing Hot Flashes in Women Using Endocrine Therapy After Breast Cancer.","REDFLASH","Inclusion Criteria:\n\n* Pre-, peri- or postmenopausal women of 18 years or above;\n* Indication for endocrine therapy and already started with tamoxifen, aromatase inhibitors or luteinizing hormone-releasing hormone analogues for at least 4 weeks and planning to continue for the duration of the study;\n* Experiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention.\n\nExclusion Criteria:\n\n* Pregnant;\n* Breast feeding;\n* Patients who receive chemotherapy or immunotherapy\u002FHER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period;\n* Palliative setting;\n* Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year;\n* Creatinine clearance \\\u003C 30 ml\u002Fmin;\n* Liver cirrhosis;\n* Use of gabapentin and\u002For calcium channel antagonists within 2 weeks of study entry;\n* Use of oxybutynin before study entry;\n* Use of any other substances or therapies for the treatment of hot flashes, for instance acupuncture.",{"count":81,"type":21},260,[58],"The goal of this randomized intrapatient cross-over study is to assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer.\n\nThe objectives it aims to answer are:\n\n* To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer\n* To assess side effects of oxybutynin versus venlafaxine.\n* To assess the personal preference of women for oxybutynin versus venlafaxine in reducing hot flashes.\n* To assess quality of life of women when reducing hot flashes in women using endocrine therapy after breast cancer.\n\nParticipants will fill-out a patient diary during 15 weeks total on a daily basis and receive an (online) questionnaire three times total.\n\nResearchers will compare two groups (venlafaxine group versus oxubutynine group) to assess its efficacy concerning hot flashes.",[85,86],"Breast Cancer","Hot Flash Due to Medication","2025-01-31",{"date":89,"type":38},"2025-02-04",{"date":91,"type":38},"2024-10-03",{"date":93,"type":21},"2029-01-01",{"name":44,"class":45},""]