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NCT ID: NCT05300204 Completed - Depressive Disorder Clinical Trials

Evaluation of a Website to Improve Depression Literacy in Adolescents With Depression

Start date: January 4, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the efficacy and acceptability of the website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy (knowledge about depression, which aid the recognition, treatment or prevention of depression) in adolescents with acute or remitted depressive disorder. The investigators will examine whether the website improves depression literacy in adolescents aged 12 to 18 years with a history of depression. The investigators will also assess the acceptability of the website among the adolescents.

NCT ID: NCT05296733 Completed - Healthy Clinical Trials

A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906

Start date: April 27, 2022
Phase: Phase 1
Study type: Interventional

This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part. This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems influences how BI 456906 is taken up in the body. The purpose of Part 2 is to find out whether having liver problems influences how people with overweight and obesity tolerate different doses of BI 456906. In Part 1, participants get a single injection of BI 456906 under their skin and stay at the study site for 2 nights afterwards. They are in the study for about a month. During this time, they visit the study site about 8 more times. The doctors compare the amount of BI 456906 in the blood of healthy people and people with liver problems. In Part 2, participants get 1 or 2 injections of BI 456906 once a week under their skin for 28 weeks. At the beginning, they get lower doses of BI 456906. Over time, they get higher doses until they reach a certain dose of BI 456906. This dose is then maintained until the end of the treatment. Participants in Part 2 are in the study for about 7 months. During this time, they visit the study site about 16 times and get about 15 phone calls from the site staff. The doctors record the number of people with health problems that could have been caused by treatment with BI 456906. They compare the results between participants with liver problems and those without liver problems. In both parts, doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05295485 Completed - Emergencies Clinical Trials

Evaluation of the Course Format "NASIM25"

Start date: March 25, 2022
Phase:
Study type: Observational

The investigators intend to evauate the development and professional safety of aspiring prehospital emergency pyhsicians in a cross sectional and longitudinal modality. This compass objecitve and subjective evaluable professional skills essential in prehospital emergency medicine.

NCT ID: NCT05295160 Completed - Obesity Clinical Trials

Fasting-Associated Immune-metabolic Remission of Diabetes

FAIR
Start date: September 25, 2020
Phase: N/A
Study type: Interventional

People with a body mass index above 28 kg/m² and an onset of type 2 diabetes within the last 4 years had a remission (HbA1c <6.5% without medication) of diabetes in over 80% upon weight loss of 15 kg. Longer duration of diabetes reduced the chance of remission. The investigators will test whether there is a difference in remission upon weight loss of 15 kg using formula low calorie diets between subjects with a diabetes duration of <4 years vs. >8 years and oral treatment as primary end points. The immune metabolic programming of circulating monocytes will be investigated in detail regarding trained innate immunity and the endocrine responses will be determined using meal challenge tests.

NCT ID: NCT05294094 Completed - Clinical trials for Diagnosis, Psychiatric

Learning Diagnostic Skills Online (German: Diagnostik Skills Online Lernen)

DiSkO
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

Clinical psychologists give diagnoses to their patients everyday and these diagnoses determine if and how these patients will be treated. Misdiagnoses can have severely adverse effects. Therefore, teaching diagnostic skills to clinical psychologists is very important during their undergraduate, graduate and postgraduate training. One major problem in teaching diagnostics is that there are too few opportunities to practice with real patients due to legal and ethical restrictions. The aim of the DiSkO-project is, therefore, the development and evaluation of a blended learning course to teach diagnostic skills to (future) clinical psychologists. In order to make the diagnostic training more practical a series of video files of simulated diagnostic interviews will be presented in an online course. These video files will be divided in different segments and presented with questions and automatic feedback. In a second step, learners will make a transfer to a real face-to-face diagnostic situation with an actor simulating a patient. The DiSkO- course will be evaluated in a randomized-controlled trial at three universities in Germany (Ruhr-University of Bochum, Philipps University of Marburg, University of Cologne). To test whether students are equally good in administering a diagnostic interview after taking the DiSkO-course compared to students who took part in a traditional face-to-face university course a noninferiority-analysis will be conducted. Furthermore, diagnostic knowledge and attitudes toward evidence-based assessment after taking part in DiSkO vs. the face-to-face course will be compared. The investigators aim at disseminating the open source DiSkO-course to other universities or institutions of tertiary education in Germany with the aim of improving the diagnostic training for students, better prepare them for their clinical practice and thus improve patients' health care in Germany.

NCT ID: NCT05293288 Completed - Hypotension Clinical Trials

Effect of EEG-guided General Anesthesia on Cumulative Dose of Norepinephrine

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Intraoperative hypotension is common in patients having non-cardiac surgery under general anesthesia and is associated with major postoperative complications including myocardial injury, AKI, and death. Intraoperative hypotension is also common in patients having vascular surgery. To treat intraoperative hypotension, vasopressors - such as norepinephrine - and fluids are used. However, high-dose vasopressor and excessive fluid therapy are also associated with postoperative complications. The depth of general anesthesia may be a modifiable cause of intraoperative hypotension. Deep levels of general anesthesia may cause cardiovascular depression with intraoperative hypotension and higher vasopressor requirements. Optimal depth of general anesthesia is defined as a state in which the patient is at low risk of recall of intraoperative events while maintaining blood pressure stability with minimal intervention. Depth of anesthesia can be confirmed using clinical signs, the concentration of inhaled or intravenous anesthetics, or neuromonitoring such as processed electroencephalography (pEEG). pEEG presents an opportunity to monitor changes in human brain electrical activity and to help estimating the patients' level of (un)consciousness and the optimal depth of anesthesia. EEG-guided general anesthesia may thus decrease norepinephrine doses needed to treat intraoperative hypotension in patients having surgery.

NCT ID: NCT05292131 Completed - Clinical trials for Healthy Study Participants

A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

Start date: March 17, 2022
Phase: Phase 1
Study type: Interventional

The purpose of the study is to compare the pharmacokinetics (PK), safety and tolerability of a single subcutaneous (sc) dose of bimekizumab (BKZ) when administered using bimekizumab-autoinjector (AI)-2mL presentation versus bimekizumab-AI-2x1mL presentation in healthy study participants.

NCT ID: NCT05291637 Completed - Clinical trials for Stroke, Acute Ischemic

Posterior cerebraL ArTery Occlusion Study

PLATO
Start date: January 5, 2022
Phase:
Study type: Observational

For this retrospective study, the investigators will collect and analyze data of patients who presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular stroke treatment). The electronic health records will be queried for the demographic, medical history, and outcomes data of all patients with posterior cerebral artery occlusion who underwent mechanical thrombectomy, intravenous thrombolysis (IVT), or medical management.

NCT ID: NCT05291611 Completed - Clinical trials for Obsessive-Compulsive Disorder

Smart Sensory Technology in Psychotherapy for Pediatric OCD

SSTeP-KiZ
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Telemedicine interventions enable the improvement of behavioral state-of-the-art treatment of OCD, as therapy can be delivered in the patients' immediate home environment, allowing for more valid symptom actualization. In addition, access to experts is made possible even in rural areas, and the inhibition to seek therapy can be reduced. In a preliminary study, our research group was able to demonstrate the efficiency of using telemedical access. SSTeP-KiZ aims at the further development of telemedical treatment of children with OCD by using sensor technology in the home setting, where most symptoms occur. In this context, relevant emotional states of the patients such as anxiety and stress reactions shall be quantified reliably during the therapy session with exposures by combining different sensor modalities. As a result, the therapy procedure can be immediately and individually adapted to the patient and the situation, thus optimizing the success of the treatment. Methods: It is planned to establish the therapy system on a sample of 10 healthy children and 5-10 patients with OCD treated at University Hospital of Tübingen. Afterwards we will recruit 26 children with obsessive-compulsive disorder aged 12-18 years to conduct therapy with them. There are 14 weekly therapy sessions via teleconferencing with the children and parents. During the sessions and exposures, patients' field of view is recorded via eye trackers, measures of stress responses via heart rate and pupillometry, and movement measures for approach-avoidance behaviors. Using an AI approach, these indicators are integrated and reported back to the therapist online to optimize the therapy process. Accompanying app-based daily symptoms will also be collected by the children and parents and processed for use in the therapy process. We expect a good feasibility and significant symptom reduction by this therapeutic approach and the chance to make this system usable for broad clinical application.

NCT ID: NCT05291546 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants

Start date: April 13, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to: • Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially. The secondary objectives of the study are to: - Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of REGN5381 - Evaluate the hemodynamic effects of single IV doses of REGN5381 - Evaluate the persistence of the hemodynamic effects of single IV doses of REGN5381 and the reversal of REGN5381 effects by REGN9035 (compared to placebo) - Evaluate the pharmacokinetics of single IV doses of REGN5381 and REGN9035 administered alone or sequentially