Inowroc?aw, Poland
Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
The scientific aim of the study is to conduct a multicenter, blinded, randomized and actively controlled trial to test the hypothesis that maintenance ECT (mECT) plus clozapine is superior to treatment with clozapine alone in CRS. Prior to the start of mECT (phase II), an acute ECT series (phase I) should have already led to a significant clinical improvement in CRS patients. The superiority of mECT will be proven by a longer time to relapse and secondarily by a lower number of patients with relapse compared to the control group. Secondary objectives are to test the hypotheses that the global level of functioning and quality of life will increase, and that depression, overall symptoms of the schizophrenic syndrome, concomitant catatonic symptoms, stress and self-stigmatization will decrease compared to the control group. It is also expected that cognitive performance will not only not deteriorate, but will improve over the course of the mECT. Once the positive ethics votes have been obtained, the first patients will be included at the individual centers following successful center initiation. In month 12 at the latest, the first patient should leave phase I after 6 weeks as a responder and will be randomized in phase II (clozapine versus clozapine plus mECT). At month 30 the last patient (total n = 84) should have been randomized as a responder from phase I and been included in phase II. At month 36 the last planned patient completes phase II of the study with his/her last study visit. Accordingly, he/she is the last patient to start the 12-month follow-up phase. In month 46 investigators will start final data evaluation and analysis. Investigators will complete the primary publication of the study this time point. After 4 years the last patient completes the 12-month follow-up phase. At study end final data evaluation and analysis regarding the primary endpoint of the follow-up phase takes place as well as the completion and submission of the primary publication of the follow-up.
Phase
N/ASpan
181 weeksSponsor
Central Institute of Mental Health, MannheimIngolstadt
Recruiting
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Within the current trial, two novel strategies are tested in a randomized fashion in patients with atrial fibrillation and status post intracranial bleeding. Patients with ICH were usually excluded from the large NOAC trials and were also not representatively included in the large Watchman device trials. On the other hand, registries show that there is a significant proportion of patients with status post ICH that were implanted with a LAA closure device in clinical routine, and also there are those patients treated with NOAC due to their high stroke risk, despite the risk of recurrent ICH. Both therapies, NOAC and LAA closure are effective in preventing stroke in patients with AF at high risk for stroke. Also, for both therapies there is evidence for prevention of bleedings, especially intracranial bleeding events. Patients within the LAA closure group will have the chance after successful closure of the LAA to quit oral anticoagulation medication and therefore reduce their lifetime risk for bleeding and recurrent bleeding. Patients in the NOAC group are provided with an excellent protection against stroke and a significant reduced bleeding risk compared to Vitamin K antagonist therapy. The trial will help to develop data and hopefully guidelines for management of patients with AF and status post intracranial bleedings. It may help to give physicians data to therapy patients post ICH adequately and help to reduce mortality rates in those patients.
Phase
N/ASpan
368 weeksSponsor
Jena University HospitalIngolstadt
Recruiting
Ingolstadt
Recruiting
Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)
The trial will consist of both a clinical and translational part. During the study, re-assessments (radiologic assessment, blood and QoL) will be conducted for all trial subject of the trial every 3 months. Tumor biopsies will be collected at screening (baseline sample) and in case of relapse of disease if a new tumor sample is obtained. The objective of the re-assessments is detection of relapse either radiologically or within the translational material (blood samples with ctDNA dynamics and tumor - if available from relapses). CT scans of thorax/abdomen and/or MRI scans will be performed every 3 months within the 2 years after randomization. After the first two relapse-free years, intervals should be stretched to 6 months in the third and following years after study start. Structured follow-up for up to 60 months after randomization should be maintained for both arms. Patients in Arm A receive additive study drug intervention (mFOLFOXIRI or mFOLFOX-6) for up to six months (12 cycles) after randomization with additional clinical and safety assessments.
Phase
3Span
469 weeksSponsor
Dominik Paul ModestIngolstadt
Recruiting
BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction
Summary: The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria. Subjects must be enrolled within 30 days from implant but prior to therapy activation. Up to 70 subjects will be enrolled at up to 10 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3 and 6 months after the device was implanted, at which time each subject will be exited from the registry. Eligibility Criteria: The CE-Mark approved indications and contraindications for the BAROSTIM NEO system in the treatment of resistant hypertension include: - Indications - Systolic blood pressure greater than or equal to 140 mmHg, and - Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications - Contraindications - Bilateral carotid bifurcations located above the level of the mandible - Baroreflex failure or autonomic neuropathy - Uncontrolled, symptomatic cardiac bradyarrhythmias - Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50% - Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
Phase
N/ASpan
384 weeksSponsor
CVRx, Inc.Ingolstadt
Recruiting
BAROSTIM THERAPY™ In Resistant Hypertension
Summary: The CVRx BAROSTIM THERAPY in Resistant Hypertension Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted. After 12 months, data may be obtained in six month intervals for up to three years after implant, at which time each subject will be exited from the registry. Eligibility: Subjects must sign an Ethics Committee (EC) approved informed consent form for the registry to participate. Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension. These include: - Indications - Systolic blood pressure greater than or equal to 140 mmHg, and - Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications - Contraindications - Bilateral carotid bifurcations located above the level of the mandible - Baroreflex failure or autonomic neuropathy - Uncontrolled, symptomatic cardiac bradyarrhythmias - Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50% - Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
Phase
N/ASpan
399 weeksSponsor
CVRx, Inc.Ingolstadt
Recruiting
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
Summary: The CVRx BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction (HFrEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for heart failure. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted, at which time each subject will be exited from the registry. Eligibility: Subjects can be included in the Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure. The BAROSTIM NEO System is indicated for subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy. The contraindications are: - Bilateral carotid bifurcations located above the level of the mandible - Baroreflex failure or autonomic neuropathy - Uncontrolled, symptomatic cardiac bradyarrhythmias - Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50% - Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation Objectives: To describe change in the following measures at 3, 6 and 12 months compared to pre-implant baseline: - New York Heart Association (NYHA) Class - Six Minute Hall Walk - Echocardiogram measures - Biomarkers (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C). Evaluate health care utilization over follow-up, such as heart failure hospitalizations. Describe device programming and utilization
Phase
N/ASpan
399 weeksSponsor
CVRx, Inc.Ingolstadt
Recruiting
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
This study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. Enrollment caps will be implemented to ensure patients from approved indications are represented. Individuals who are scheduled to receive an implantable Abbott neurostimulation system are eligible for study consideration. The study will enroll up to 2,000 subjects from up to 100 participating centers. Subject enrollment is expected to be completed within 7 years; subjects will be followed for 5 years. The total duration of the study is expected to be 13 years, including enrollment, data collection from all subjects, and study close out.
Phase
N/ASpan
564 weeksSponsor
Abbott Medical DevicesIngolstadt, Bavaria
Recruiting
AcandiS Stenting of Intracranial STENosis - regisTry
ASSISTENT is subdivided into two components. The first part only requires recording of data acquired in routine clinical practice during the treatment of patients with intracranial stenosis with the self-expandable Credo® stent until discharge. This comprises demographic data, data concerning the qualifying clinical event, limited data on medical history and medication, information about the intervention including technical success and periprocedural complications or events, and information about events and clinical status during the in-hospital treatment until hospital discharge. The second part of the registry consists of a follow-up visit 30 days after the interventional procedure which will be conducted outside of clinical practice.
Phase
N/ASpan
496 weeksSponsor
Acandis GmbHIngolstadt
Recruiting
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers.
Phase
N/ASpan
242 weeksSponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIngolstadt
Recruiting