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NCT ID: NCT05211505 Completed - Vaginal Atrophy Clinical Trials

Investigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness

Start date: January 31, 2022
Phase: Phase 4
Study type: Interventional

The objective of the clinical investigation is to evaluate the efficacy and tolerability of WO 2707, a MoistCream Cremolum, with respect to the application in postmenopausal women with symptoms of vaginal dryness.

NCT ID: NCT05209828 Completed - Clinical trials for Patient Satisfaction

Post-market Clinical Follow-up of Pfmmedical Ports

Start date: April 13, 2022
Phase:
Study type: Observational

Prospective, monocentric, non-randomised, observational post-market clinical follow-up study in Germany to obtain post-market information on the pfmmedical ports with a follow-up (FU) of 6 months. The focus is on patient reported satisfaction, clinical application, and complication rates.

NCT ID: NCT05208788 Completed - Clinical trials for Renal Transplantation

Urinary Biomarkers in Paediatric Kidney Transplantation (pKTx)

Start date: June 1, 2021
Phase:
Study type: Observational

This study aims to test and validate the panel of study urinary biomarker to assess whether (1) reference values differ between paediatric renal transplant patients, patients with chronic kidney disease stage IV and V (CKD IV-V) and children without any disease, (2) characteristic changes in concentration profile may be observed after event-specific injury, (3) differences between paediatric renal transplant patients with AR and other causes of AKI can be detected, and (4) stratification of renal transplant patients to different histological types of AR is possible.

NCT ID: NCT05208346 Completed - Clinical trials for Cardiovascular Diseases

Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk

Start date: March 9, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the postprandial effects of fat content and fatty acid composition of mixed meals on parameters associated with cardiometabolic diseases. Therefore, older subjects with increased risk of cardiometabolic diseases consume 4 mixed meals with 25 or 50 g of either canola or coconut oil. In a postprandial period of 6 hours, outcomes associated with cardiometabolic risk (e.g., triglycerides) are analyzed.

NCT ID: NCT05208294 Completed - Clinical trials for Placebo Effect on Mood Improvement

The Role of Dopamine, Reward Learning and Prefrontal Activity in Expectation-induced Mood Enhancement

CRC289A07
Start date: December 9, 2021
Phase: N/A
Study type: Interventional

Although placebo effects on depressive symptoms are well documented, the underlying mechanisms and moderating factors of expectation effects on mood and depression are poorly understood. Various studies show reduced reward processing in clinical and subclinical depression, presumably due to abnormalities in the dopamine (DA) system. Here, the investigators will test whether expectation-induced mood enhancement is mediated by endogenous DA activity and reward learning, and moderated by individual differences in depression-related personality traits. Healthy participants (N=296) will be tested for potentially relevant personality traits and given an inactive substance (placebo) or a DA D2-receptor antagonist sulpiride (400 mg) in combination with a low vs. high expectation manipulation (fully crossed 2x2 placebo design) before performing a probabilistic reinforcement learning task, an effort expenditure task, and undergo a depressed mood induction procedure. Further, EEG indices will be assessed throughout the tasks. The investigators expect that positive expectation improves participants' reinforcement learning, increases participants' willingness to make effort in order to obtain reward, and leads to less depressive symptoms as indicated by mood ratings upon depressive mood induction. If the overall effect of positive expectations is mediated by DA, high-dose sulpiride should block expectation-induced effects, i.e., the anticipated enhanced reinforcement learning and effort expenditure as well as mood improvement in the high vs. low expectation group.

NCT ID: NCT05205889 Completed - Clinical trials for Chronic Pain Syndrome

A Mobile Intervention on Values in Chronic Pain Patients.

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

The study aims to test a mobile intervention on values and goals in chronic pain patients. The cognitive behavioral intervention is a 10-day course in which participants complete a brief intervention each day (about 10-20 minutes a day). The content of the intervention includes the definition of values; development of individualized values and personal value-oriented goals; and implementation of personal goals in every day life. To assess the effectiveness of the intervention, we use a multiple baseline single case design. Baseline measurements will be assessed daily between 10 and 17 days (the exact number will be randomized). Daily measurements will continue during the intervention. After the intervention, another post measurement will be collected.

NCT ID: NCT05203822 Completed - Healthy Clinical Trials

Tepotinib Drug-Drug Interaction Study With Itraconazole in Healthy Participants

Start date: January 21, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study was to assess the effect of multiple doses of itraconazole on single dose tepotinib pharmacokinetics in healthy participants. Study details include: Study Duration: up to 48 days Treatment Duration: single dose of tepotinib on Days 1 and 12, 11 days of treatment with itraconazole (Days 8 to 18) Visit Frequency: residence in the Clinical Research Unit from Days -1 to 4 and Days 11 to 15, ambulatory daily visits from Days 5 to 10 and 16 to 20

NCT ID: NCT05200871 Completed - Clinical trials for Focal Segmental Glomerulosclerosis

Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)

HONUS
Start date: February 5, 2022
Phase:
Study type: Observational

The aim of this observational study is to assess humanistic burden among adults and children/adolescents with FSGS and IgAN as well as the burden and impact for patient care-partners in six countries (United States [US], United Kingdom [UK], France, Germany, Italy and Spain).

NCT ID: NCT05200416 Completed - Ileostomy - Stoma Clinical Trials

Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product

Start date: January 13, 2022
Phase: N/A
Study type: Interventional

People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively. To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status. The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.

NCT ID: NCT05199805 Completed - Chronic Pain Clinical Trials

Mindfulness-Based Pain Management (MBPM) for Patients With Chronic Musculoskeletal Pain

Start date: January 21, 2022
Phase: N/A
Study type: Interventional

Mindfulness-Based Pain Management (MBPM) is an eight-week behavioral medicine program. Based on the well-known Mindfulness-Based Stress Reduction (MBSR) program, it was specifically developed as an intervention for chronic pain. During the program, mindfulness exercises, gentle body exercises and body awareness and breathing exercises, as well as pain regulation methods are taught. Initial studies suggest efficacy of the program with regard to chronic pain, however, the effect of the standardized program in patients with chronic musculoskeletal pain has not yet been investigated in a clinical study. Therefore, the aim of this study is to investigate the MBPM program on pain acceptance in patients with chronic musculoskeletal pain. To this end, 40 patients with chronic (specific and non-specific) musculoskeletal pain will be randomly assigned to two study conditions. The intervention group will receive MBPM sessions of 150 minutes once a week over the course of 8 weeks, while the control group will receive standard therapy (waiting list). We hypothesize that patients will indicate a significantly higher pain acceptance after completing the program compared to patients not participating in the program.