[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Philipps University Marburg\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":333},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,50,81,113,142,164,184,201,225,250,276,308],{"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":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100629543","improved-management-of-patients-with-recent-onset-stable-chest-pain-100629543",false,"NCT07476040","Improved Management of Patients With Recent-Onset Stable Chest Pain","A Pragmatic, Cluster-randomised Stepped-wedge Trial to Evaluate the Effectiveness of a New Cross-sectoral Form of Care (NVF) in Patients With New-onset Stable Chest Pain and Suspected Coronary Artery Disease (CAD).","IMPRO","Inclusion Criteria:\n\n* Age ≥30 years\n* Suspected CAD with stable chest pain\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Known or previously treated (with PCI or CABG) obstructive CAD (defined as at least one coronary diameter stenosis ≥50%)\n* Acute coronary syndrome\n* Negative invasive coronary angiography or coronary CT within the last 5 years\n* Already enrolled in the study\n* Not covered by statutory health insurance\n* Unable to give consent","ALL","30 Years",{"count":20,"type":21},3369,"ESTIMATED","INTERVENTIONAL",[24],"NA","In Germany, coronary CT offers an accurate and less burdensome alternative to cardiac catheterisation for evaluating suspected coronary artery disease, but it is still underused. The IMPRO stepped-wedge trial tests a new, nationwide care model (NVF) in 16 regions to improve guideline-based intersectoral implementation of coronary CT and assess its impact on cardiovascular outcomes and healthcare costs. If effective, the model of care (NVF) could be adopted across Germany to enhance care quality while reducing unnecessary procedures and expenses.",[27],"Coronary Artery Disease (CAD)",[29,30,31,32,33,34,27,35,36,37],"Coronary Heart Disease","Coronary Angiography","Percutaneous Coronary Intervention","Evidence-Based Practice","Shared Decision Making","Health Care Quality Assurance","computed tomography","stepped-wedge trial","health services research","RECRUITING","2026-04-01",{"date":41,"type":42},"2026-04-07","ACTUAL",{"date":39,"type":42},{"date":45,"type":21},"2028-03",{"name":47,"class":48},"Philipps University Marburg","OTHER",39,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100631294","phase-2-sota-es---sotatercept-in-patients-with-congenital-heart-disease-and-eisenmengers-syndrome-100631294","NCT07498803","Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome","Sota-ES - A Prospective, Non-randomized, Open-label, Multi-center Study of the Activin Signaling Inhibitor Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome","CHASE","Inclusion Criteria:\n\n* Age ≥18 years\n* Congenital heart disease with Eisenmenger syndrome (known unrepaired atrial septal defect, and\u002For ventricular septal defect, and\u002For patent ductus arteriosus; patients with anomalous pulmonary venous drainage will not be considered)\n* Eisenmenger syndrome defined as right-to-left or bi-directional shunt with a mPAP \\>25 mmHg, PAWP \\\u003C 15 mmHg, and PVR \\>5 WU\n* In patients with pre-tricuspid shunt, the consideration of Eisenmenger syndrome requires one of the following: Systemic arterial O2 saturation (SaO2) at rest \\\u003C88% and more than 70%, and\u002For SaO2 \\\u003C80% during 6MWT, and secondary erythrocytosis (Hb \\> 15.0 g\u002Fdl for females and 16.0 g\u002Fdl for males)\n* On stable doses of background PAH therapy\\* and diuretics (i.e., patient-individual dose goal for each therapy achieved) for ≥30 days\n* 6-minute walking distance \\>100 m\n* WHO-FC II or III\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n\n  * Diagnosis of pulmonary hypertension groups 2, 3, 4, or 5\n  * Hospitalization or change in PAH background therapies within 30 days prior to screening (changes in dose of diuretics or parenteral prostanoids \\[\\\u003C10% change in infusion rate over the preceding 3 months\\] are allowed)\n  * Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \\>160 mmHg or sitting diastolic blood pressure \\>100 mmHg during screening visit after a period of rest\n  * Baseline systolic blood pressure \\\u003C90 mmHg at screening\n  * Left ventricular systolic dysfunction (LVEF 40%)\n  * Restrictive lung disease with a TLC \\\u003C 60% AND demonstration of more than mild fibrosis on chest CT prior to enrolment (note that patients with congenital heart disease may have thoracic cage deformities \\[e.g. pectus\\] that may lead to thoracic cage restriction in the absence of parenchymal lung disease).\n  * Obstructive lung disease (FEV1 \\\u003C 60% pred. and FEV1\u002FFVC \\\u003C60%)\n  * Chronic thromboembolic disease (intermediate or high probability) on V\u002FQ scan and evidence of distal thromboembolism on CT angiography (note that proximal in-situ thrombosis is a known complication of Eisenmenger's and will not be considered an exclusion criterion - such patients may be reviewed centrally for inclusion)\n  * Significant liver disease (Child II or III)\n  * Any of the following clinical laboratory values at the screening visit:\n\n    * Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002Fm2 (as defined by the Modification of Diet in Renal Disease \\[MDRD\\] equation)\n    * Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels \\>3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome)\n  * Baseline platelet count \\\u003C50,000\u002Fµl (\\\u003C50.0 x 109\u002FL) at screening\n  * Documented episodes of previous repetitive hyperviscosity syndrome\n  * History of haemoptysis within 12 months prior to screening, and\u002For repeated severe epistaxis (≥ 1 episode per month)\n  * Uncorrected iron deficiency (iron stores must be normal defined as a Ferritin \\> 100 and transferrin saturation \\[TSAT\\] ≥ 20%)\n  * Recent (\\\u003C 3 months) enrolment into a rehabilitation program\n  * Untreated sleep disordered breathing with an AHI \\> 10. Patients with sleep apnea will need to have been on CPAP or BiPAP for 3 months prior to enrolment.\n  * Prior or current exposure to sotatercept or luspatercept\n  * Treatment by phlebotomy within 1 month prior to screening\n  * Participation in another interventional study\n  * Pregnant (serum B-HCG) or lactating women","18 Years",{"count":60,"type":21},40,[62],"PHASE2","The present study seeks to provide pilot data on the safety and efficacy of medical therapy with sotatercept in patients with an established diagnosis of congenital heart disease and Eisenmenger syndrome.\n\nCHASE is an interventional, single-arm, open-label study, that will enroll 40 patients with an established diagnosis of CHD and Eisenmenger syndrome. PAH background therapy may be present at the discretion of the investigators at the time of enrolment. CHASE will be performed only in countries where standard PAH therapies are available and reimbursed. At the end of the 24-week patient period, PAH treatment is left to the investigator's discretion.",[65,66,67],"Congenital Heart Disease (CHD)","Eisenmenger Syndrome","PAH",[69,70,71],"Congenital heart disease with Eisenmenger syndrome","WHO-FC II or III","PAH therapy","NOT_YET_RECRUITING","2026-03-23",{"date":75,"type":42},"2026-03-27",{"date":77,"type":21},"2026-09-01",{"date":79,"type":21},"2028-12-31",{"name":47,"class":48},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100622775","group-therapy-for-major-depression-comparing-expectation-focused-and-reward-focused-psychotherapy-approaches-100622775","NCT07388004","Group Therapy for Major Depression: Comparing Expectation-Focused and Reward-Focused Psychotherapy Approaches","Rewiring Expectations and Amplifying Rewards: A Study Protocol for a Randomized Controlled Trial of Mechanism-Based Group Psychotherapy for Major Depressive Disorder","PERSPECT","Inclusion Criteria:\n\n* Age: 18-80 years\n* Current diagnosis of major depressive disorder (MDD) according to DSM-5, confirmed by structured clinical interview (e.g., DIPS)\n* Hamilton Depression Rating Scale (HAMD-21) score ≥ 9\n* Ability to attend group therapy sessions (2×\u002Fweek for 5 weeks)\n* Ability to undergo MRI scanning (for participants in the fMRI component) Written informed consent\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of bipolar disorder, psychotic disorder, or primary substance use disorder\n* High acute suicide risk requiring immediate intervention\n* Severe neurological disorder, brain injury, or contraindications for MRI (e.g., metal implants, claustrophobia)\n* Ongoing psychotherapy or initiation of a new antidepressant medication within the past 4 weeks\n* Insufficient German language proficiency to participate in therapy and complete study assessments\n* Cognitive impairment or other conditions interfering with informed consent or study participation","80 Years",{"count":91,"type":21},150,[24],"Major depressive disorder (MDD) is one of the most common psychiatric conditions and often remains difficult to treat effectively. Many patients continue to experience residual symptoms or relapse even after receiving established forms of psychotherapy. This study tests whether targeting specific psychological mechanisms can improve outcomes for people with depression. We compare two novel group therapies: (1) Expectation-Focused Psychotherapeutic Intervention (EFPI), which aims to modify rigid, negative expectations that maintain depressive symptoms, and (2) Reward Enhancement and Activation Therapy (REACT), which focuses on increasing sensitivity to positive experiences and strengthening reward-related learning. Both are delivered in a group format to foster peer support and shared learning.\n\nA total of 150 adults with a current MDD diagnosis will be randomly assigned to EFPI, REACT, or a waiting-list control. Participants in the intervention groups receive 10 group sessions over five weeks. Waiting-list participants complete baseline and 3-month follow-up assessments before being offered standard treatment options.\n\nClinical outcomes are assessed at baseline, immediately after treatment, and at 3- and 6-month follow-ups (for the intervention groups). Primary outcomes are reductions in depressive symptoms measured by clinician ratings and self-report questionnaires. Secondary outcomes include changes in expectation processes and reward sensitivity.\n\nIn addition, functional MRI (fMRI) tasks examine brain mechanisms related to expectation updating and reward processing pre- and post-intervention, to help identify neural changes that may underlie symptom improvement.\n\nBy directly addressing dysfunctional expectations and reduced reward sensitivity, this study seeks to provide evidence for more targeted psychotherapeutic approaches. If successful, the results may support more personalized treatments and better long-term outcomes in MDD.",[95],"Major Depressive Disorder (MDD)",[97,98,99,100,101,102,103],"Major Depressive Disorder","Psychotherapy","Group Therapy","Expectation Violation","Reward Sensitivity","Mechanism-Based Intervention","Randomized Clinical Trial","2026-02-05",{"date":106,"type":42},"2026-02-10",{"date":108,"type":42},"2025-10-13",{"date":110,"type":21},"2028-06-30",{"name":47,"class":48},1,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":112},"100617813","enhancing-generalization-of-virtual-reality-exposure-for-public-speaking-anxiety-100617813","NCT07323498","Enhancing Generalization of Virtual Reality Exposure for Public Speaking Anxiety","Enhancing Generalization of Virtual Reality Exposure for Public Speaking Anxiety Via Imagery-Based Extinction Memory Updating: A Randomized Controlled Trial","VREX2","Inclusion Criteria:\n\n* speech anxiety scale score of ≥ 18 on the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)\n* Self-report of 18 - 70 years of age\n\nExclusion Criteria:\n\n\\-","70 Years",{"count":123,"type":21},48,[24],"This randomized controlled trial examines whether imagery-based extinction memory updating following a standardized virtual reality (VR) exposure session improves the generalization of exposure effects to novel public speaking contexts. Individuals with elevated public speaking anxiety will complete a single-session VR speech exposure. Participants are randomized to (a) standard mental rehearsal of the exposure experience or (b) mental rehearsal plus guided imagery that updates the extinction memory with novel, non-exposed contexts. Generalization is assessed 7-14 days later using a multi-context behavioral approach test (BAT) in vivo and in VR.",[127,128],"Public Speaking Anxiety","Public Speaking Fear",[130,131,132,133],"virtual reality exposure","extinction generalization","fear extinction","exposure therapy","2026-01-07",{"date":136,"type":42},"2026-01-09",{"date":138,"type":42},"2025-11-26",{"date":140,"type":21},"2026-12",{"name":47,"class":48},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":112},"100604932","ecological-momentary-intervention-for-reward-in-anhedonia-100604932","NCT07155941","Ecological Momentary Intervention for Reward in Anhedonia","EMIRA","Inclusion Criteria:\n\n* German speaking\n* Smartphone available and willingness to participate in repeated training units and questions delivered via app\n* Clinically elevated anhedonia (SHAPS \\>= 25) and elevated depression (DASS-21-Depression \\>= 10), elevated anxiey (DASS-21-Anxiety \\>= 6) or elevated stress (DASS-21-Stress \\>= 10)\n\nExclusion Criteria:\n\n* Psychotropic medication\n* Psychotherapy currently ongoing or planned during participation\n* Suicidality, lifetime diagnosis of bipolar disorders or psychotic episodes",{"count":150,"type":21},60,[24],"The present study evaluates a two week ecological momentary intervention (EMI) in reducing anhedonia and psychological distress (i.e. elevated depression, stress and anxiety). Participants in the experimental group complete three daily exercises targeting reward-related processes, including positive mental imagery, savoring, gratitude, taking ownership for positive experience, and silver lining. These components were selected to improve reward anticipation as well as reward consumption and reward learning as the underlying mechanisms of anhedonia. An active control group receives progressive muscle relaxation training, matched in format and frequency. Exercise units are presented using audio recordings via smartphone app.",[154,155,156,157],"Anhedonia","Anxiety","Stress","Depression",{"date":136,"type":42},{"date":160,"type":42},"2025-06-18",{"date":162,"type":21},"2026-01",{"name":47,"class":48},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":171,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":183,"locationsCount":112},"100591181","the-efficacy-of-prospective-mental-imagery-in-enhancing-approach-motivation-among-socially-anxious-individuals-100591181","NCT06977087","The Efficacy of Prospective Mental Imagery in Enhancing Approach Motivation Among Socially Anxious Individuals","The Efficacy of Prospective Mental Imagery in Enhancing Approach Motivation Among Socially Anxious Individuals: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Elevated score on Mini-Social Phobia Inventory (Mini-SPIN) \\> 6\n* Moderate fear and avoidance of two specified social situations (i.e., giving a stranger a compliment and asking for a restaurant recommendation), each rated above 5 on a Likert scale ranging from 0 (not at all) to 10 (extremely), respectively\n* Avoidance of the two specified social situations (i.e., giving a stranger a compliment and asking for a restaurant recommendation), indicated by not having engaged in either behaviors in the past 7 days",true,{"count":173,"type":21},58,[24],"The efficacy of an online intervention aimed at enhancing approach motivation and behavioral engagement in confronting anxiety-inducing social situations is examined among individuals with elevated social anxiety. Participants will receive psychoeducation, followed by either a prospective mental-imagery task or a verbal reasoning task. Efficacy of the intervention is measured by ratings of experienced and anticipated pleasure, approach motivation and self-reported engagement with feared situations one week later.",[177,178],"Social Anxiety","Social Phobia",{"date":136,"type":42},{"date":181,"type":42},"2025-03-04",{"date":162,"type":21},{"name":47,"class":48},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":171,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":112},"100559459","augmentation-of-exposure-using-positive-mental-rehearsal-in-individuals-with-increased-social-anxiety-100559459","NCT06564402","Augmentation of Exposure Using Positive Mental Rehearsal in Individuals With Increased Social Anxiety","APEX","Inclusion Criteria:\n\n* Elevated score on Social Interactions Anxiety Scale (SIAS) \\> 26\n\nExclusion Criteria:\n\n* Current psychotherapeutic\u002Fpsychiatric treatment\n* Plans to start psychotherapeutic\u002Fpsychiatric treatment in upcoming weeks\n* Current suicidal intent\n* Severe cardiovascular, respiratory or neurological diseases",{"count":60,"type":21},[24],"Efficacy of an optimized exposure therapy training is investigated in individuals with heightened social anxiety. Participants will undergo a one-session standardized exposure training, followed by either standard or positive mental rehearsal of the exposure experience. The efficacy is measured by symptom improvement according to subjective ratings one week later.",[177,178],{"date":136,"type":42},{"date":197,"type":42},"2024-05-28",{"date":199,"type":21},"2026-03-01",{"name":47,"class":48},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":112},"100483059","phase-1-enoxolone-in-major-depression---biomarker-outcome-relationship-100483059","NCT05570110","Enoxolone in Major Depression - Biomarker-outcome Relationship","Double-blind Randomized Placebo Controlled Study on the Effect of Enoxolone ( 11-beta Hydroxysteroid-dehydrogenase Type 2 Inhibitor) on the RAAS, Autonomic and Imaging Biomarkers and the Outcome of Depression","Inclusion Criteria:\n\n* Unipolar Depression\n* in women: Contraceptive means\n\nExclusion Criteria:\n\n* Schizophrenic and delusional disorders\n* Neurological diseases in which central nervous system involvement is known, such as epilepsies, storage diseases; severe mental retardation\n* Internistic diseases of moderate or higher severity, which may make participation in the study risky from a clinical point of view. In particular, multiple systolic blood pressure (measured after at least 5 min supine position) of \\> 145 mm Hg as well as hypokalemia (\\\u003C 3.5 mmol\u002Fl) and clinically relevant ECG changes\n* Poorly controlled diabetes mellitus (HbA1c \\> 10)\n* Pregnancy or active desire for pregnancy for the duration of the study\n* Non-consent or inability to consent to the study\n* Treatment with the following substances: spironolactone or eplerenone; systemic glucocorticoids\n* Treatment with ketamine or electroconvulsive therapy in the last 3 months before randomization\n* Acute suicidality\n* Intolerance to licorice preparations or licorice contents.",{"count":209,"type":21},80,[211,62],"PHASE1","Many different forms of depression exist. It is difficult to predict to what treatment a given patient with depression responds. Studies demonstrate that biomarkers can help to distinguish different forms of depression. Simple markers, like aldosterone\u002Fcortisol in body fluids, blood pressure and inflammation markers , have been identified as predictors of therapy resistance in depression. Enoxolone is a molecule derived from the licorice plant and has demonstrated an effect on these biomarkers, which may imply an improved response. The current randomized placebo controlled study is assessing whether the presence of markers of therapy resistance can predict a preferential effect of enoxolone vs. placebo on clinical outcome. Secondarily, it is tested whether these markers change differentially in the treatment groups. Finally, the relationship between the change of the markers and clinical change will be assessed.",[214],"Unipolar Depression",[216],"Atypical depression;","2025-12-01",{"date":219,"type":42},"2025-12-08",{"date":221,"type":42},"2022-09-23",{"date":223,"type":21},"2026-06",{"name":47,"class":48},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":121,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":4},"100613432","phase-2-sirius---initial-combination-therapy-with-an-endothelin-receptor-antagonist-a-phosphodiesterase-5-inhibitor-and-sotatercept-in-patients-with-newly-diagnosed-pulmonary-arterial-hypertension-100613432","NCT07266519","SIRIUS - Initial Combination Therapy With an Endothelin Receptor Antagonist, a Phosphodiesterase-5 Inhibitor and Sotatercept in Patients With Newly Diagnosed Pulmonary Arterial Hypertension","SIRIUS - A Prospective, Non-randomized, Open-label, Proof-of-concept Study of Initial Combination Therapy With an Endothelin Receptor Antagonist, a Phosphodiesterase-5 Inhibitor and Sotatercept in Patients With Newly Diagnosed Pulmonary Arterial Hypertension A Single-arm, Multi-center, Interventional Phase II Study","SIRIUS","Inclusion Criteria:\n\n* Age 18- 70 years\n* Treatment-naïve patients diagnosed within 12 weeks prior to screening with I\u002FH\u002FD-PAH or PAH associated with corrected congenital heart disease (disease (≥12 months after correction). Patients who have received treatment with PDE5is and\u002For ERAs for up to 6 weeks after diagnosis are eligible provided that state-of-the-art right heart catheterization has been performed at PAH diagnosis.\n* PVR \\>5 WU, mPAP ≥35 mmHg and PAWP or LVEDP ≤15 mmHg at PAH diagnosis.\n* Signed written informed consent\n* Normal blood counts for platelets and erythrocytes\n* Women of childbearing potential must be willing to remain abstinent or use adequate and reliable contraception throughout the study and for at least 4 months after the last dose of study medication has been received.\n\n  * WOCBP must use one of the following highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly - according to recommendations by the European Heads of Medicines Agencies - from at least 14 days before the first administration of study medication until 4 month after the last administration of study medication:\n  * combined (estrogen and progestogen containing) hor-monal contraception associated with inhibition of ovulation:\n\n    * oral\n    * intravaginal\n    * transdermal\n  * progestogen-only hormonal contraception associatedwith inhibition of ovulation:\n\n    * oral\n    * injectable\n    * implantable\n  * intrauterine device (IUD)\n  * intrauterine hormone-releasing system (IUS)\n  * bilateral tubal occlusion\n  * vasectomized partner\n  * sexual abstinence\n* Male participants with female partner(s) of childbearing potential are eligible to participate in the study if they agree to the following during treatment and until 304 daysmonths after the last administration of study medication:\n\n  * Inform any and all partner(s) of their participation in a clinical drug study and the need to comply with contraception instructions as directed by the investigator.\n  * Male participants are required to use a condom during treatment and until 30 days4 months after the last administration of study medication.\n  * Female partners of male participants who have not undergone a vasectomy with the absence of sperm confirmed or a bilateral orchiectomy should consider use of effective methods of contraception during treatment and until 30 days4 months after the last administration of study medication.\n* Sperm donation is not allowed during treatment and until 4 months after the last administration of study medication.\n\nExclusion Criteria:\n\n* Other Forms of PH or PAH\n* Use of PAH medications for more than 6 weeks prior to screening\n* Symptoms or signs of clinically relevant lung disease, including TLC \\\u003C 70%, FEV1\u002FFVC \\\u003C60%, and DLCO \\\u003C45%, respectively\n* Signs of left heart failure with reduced or preserved ejection fraction, including LVEF \\\u003C50%, LAVI \\>34 ml\u002Fm2, E\u002Fé ≥15, or permanent atrial fibrillation, respectively.\n* History of severe bleeding\u002Fhaemorrhage\n* Therapy with prostacyclin and\u002For antithrombotic agents\n* eGFR \\\u003C30 ml\u002Fmin\u002Fm2.\n* Pregnancy or breastfeeding\n* Hypersensitivity to the active substance or to any of the excipients",{"count":234,"type":21},25,[62],"The study aims to see how 24 weeks of triple therapy-an endothelin receptor antagonist (ERA), a phosphodiesterase-5 inhibitor (PDE5i), and sotatercept-affects pulmonary vascular resistance (PVR) in patients with newly diagnosed pulmonary arterial hypertension (PAH). SIRIUS is a 24-week, single-arm, open-label study with up to 42 days of screening and a 28-day safety follow-up. It will enroll 25 patients and will be conducted only in countries where all treatments are available and covered. After 24 weeks, PAH treatment is decided by the doctor.",[238],"Pulmonary Arterial Hypertension (PAH)",[240,67,241],"triple therapy","treatment-naiive","2025-11-24",{"date":244,"type":42},"2025-12-05",{"date":246,"type":21},"2026-07-01",{"date":248,"type":21},"2028-10",{"name":47,"class":48},{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":171,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":112},"100582609","large-language-models-to-aid-gynecological-oncology-treatment-100582609","NCT06865534","Large Language Models to Aid Gynecological Oncology Treatment","Medical Students and Their Perception of Large Language Models (LLMs) in Gynecologic Oncology","EASING","Inclusion Criteria:\n\n\\- Medical students having started with clinical subjects\n\nExclusion Criteria:\n\n\\- Not being a medical student",{"count":259,"type":21},68,[24],"This trial aims to assess the impact of providing medical students with access to large language models, in comparison to treatment guideline pdfs, on treatment concordance with a conventional multidisciplinary tumor board",[263],"Breast Cancer",[265,266,267],"large language models","clinical decision support","gynecological oncology","2025-08-25",{"date":270,"type":42},"2025-08-26",{"date":272,"type":42},"2025-06-02",{"date":274,"type":21},"2025-09-01",{"name":47,"class":48},{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":283,"maxAge":284,"enrollmentInfo":285,"targetDuration":287,"studyType":288,"phases":4,"briefSummary":289,"conditions":290,"keywords":294,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},"100598343","pediatric-intensive-care-transport-registry-100598343","NCT07070258","Pediatric Intensive Care Transport Registry","PIT Registry","Inclusion Criteria:\n\n* Critically ill children aged at least 27 days and a corrected gestational age of over 41 weeks AND\n* Maximum age of 17 years AND\n* Interhospital transport AND\n* Critical care transport by a dedicated critical care transport team using an intensive care ambulance (Type C vehicle) or an air ambulance OR\n* The transport was accompanied by a specialist in intensive care or emergency medicine. OR\n* The in-hospital destination of the transport is a critical care area, such as an intensive care unit, a trauma room, a resuscitation area, an operating theatre, an emergency imaging procedure or an emergency intervention.","27 Days","17 Years",{"count":286,"type":21},1000,"1 Day","OBSERVATIONAL","The aim is to establish a nationwide registry for pediatric intensive care transports in Germany. The project aims to describe and analyse the need for, and current practice of, specialised transports. These data could then be used for future demand planning.",[291,292,293],"Critical Care Medicine","Transportation of Patients","Pediatrics",[295,296,297,298],"intensive care transport","critical care transport","pediatrics","registry","2025-07-16",{"date":301,"type":42},"2025-07-20",{"date":303,"type":42},"2024-11-25",{"date":305,"type":21},"2029-12-31",{"name":47,"class":48},2,{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":316,"minAge":58,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100319416","endometrial-cancer-lymphadenectomy-trial-100319416","NCT03438474","Endometrial Cancer Lymphadenectomy Trial","Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence","ECLAT","Inclusion Criteria:\n\n1. histologically confirmed EC of clinical stages T1b and T2 (all histological types) and stage T1a G3 type 1 (endometrioid, endometriod with squamous differentiation, mucinous) or type 2 tumors (any percentage of serous or clear cell component) or carcinosarcoma\n2. a) no previous surgery concerning EC (primary surgery) or b) surgery after hysterectomy (e.g. for presumed low risk endometrial cancer) is allowed within 8 weeks after hysterectomy if no LNE was performed (secondary surgery)\n3. absence of bulky lymph nodes\n4. performance status ECOG 0-1\n5. age 18 - 75 years\n6. written informed consent\n7. adequate compliance\n\nExclusion Criteria:\n\n1. stage pT1a, G1 or G2 tumors of type 1 histology\n2. sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)\n3. EC of FIGO stages III or IV (except for microscopical lymph node metastases)\n4. evidence of extrauterine disease by visual inspection\n5. recurrent EC\n6. preceding chemo-, radio, or endocrine therapy for EC\n7. any concomitant disease not allowing surgery including lymphadenectomy and\u002For chemotherapy\n8. any medical history indicating excessive peri-operative risk\n9. any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents)\n10. any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected.\n11. patients with second malignancies if disease or treatment might have an impact on the patient's prognosis\n12. known HIV-infection or AIDS\n13. simultaneous participation in other clinical trials if not permitted by the steering committee (translational or QoL studies not interfering with the objectives of ECLAT are allowed)","FEMALE","75 Years",{"count":319,"type":21},640,[24],"The primary aim of this trial is to ascertain whether or not systematic pelvic and para-aortic lymphadenectomy (LNE) does have a significant impact on overall survival (OS) in patients with endometrial cancer (EC) FIGO Stages I or II and high risk of recurrence. Secondary aims will be to evaluate the effect of LNE on disease free survival (DFS) and quality of life, as well as the complications and side effects of LNE and the number of resected lymphnodes. 640 patients with histologically confirmed EC with high risk of recurrence (stage pT1b - pT2, all histological subtypes; pT1a, G3 endometrioid or serous or clear cell EC or carcinosarcomas) will be randomized. In Arm A, a total hysterectomy and bilateral salpingo-oophorectomy and in case of serous or clear cell EC additionally an omentectomy will be performed. In arm B in addition a systematic pelvic and para-aortic LNE up to the level of the left renal vein will be performed.",[323,324],"Cancer of Endometrium Stage I","Cancer of Endometrium Stage II","2024-11-22",{"date":303,"type":42},{"date":328,"type":42},"2018-03-28",{"date":330,"type":21},"2029-02-15",{"name":47,"class":48},61,""]