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NCT ID: NCT05915728 Completed - Clinical trials for Contrast Enhancement in Magnetic Resonance Imaging

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)

Quanti OBR
Start date: July 24, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation. The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI. The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent. The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein. Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits. At the start or during the study, the doctors and their study team will: - take blood and urine samples - do physical examinations - check blood pressure and heart rate - review the MRI scans obtained in the study and decide on the diagnosis - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

NCT ID: NCT05915702 Completed - Clinical trials for Contrast Enhancement in Magnetic Resonance Imaging

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems

Quanti CNS
Start date: July 24, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation. The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI. The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent. The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein. Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits. At the start or during the study, the doctors and their study team will: - take blood and urine samples - do physical examinations - check blood pressure and heart rate - review the MRI scans obtained in the study and decide on the diagnosis - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

NCT ID: NCT05912868 Completed - Hernia, Ventral Clinical Trials

Endoscopic Mini/Less Open Sublay(EMILOS) Repair

EMILOS
Start date: June 25, 2015
Phase:
Study type: Observational

Ventral hernias in the midline of the abdominal wall are one of the most frequent diseases in general and visceral surgery worldwide. The optimal operative technique is still in discussion. The traditional techniques are open sublay or transabdominal intraperitoneal onlay mesh (IPOM) repair. In order to avoid the risks -large trauma to the abdominal wall with pain and infection, lesion of intraabdominal organs - a new hybrid technique - small skin incision, wide endoscopic dissection of the retrorectus space with implantation of a large mesh - was developed (EMILOS -Endoscopic Mini/Less Open Sublay).

NCT ID: NCT05905809 Completed - Clinical trials for Osteoarthritis, Knee

Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

UNIBRACE
Start date: June 7, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.

NCT ID: NCT05897853 Completed - Vertigo Clinical Trials

Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness

HealVertigo
Start date: November 29, 2021
Phase:
Study type: Observational

In this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product Vertigoheel©. Adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (BVP) or functional dizziness (FD) and assigned to Vertigoheel treatment. Participating patients receive an examination at study start and after 2 months of Vertigoheel treatment. The study focuses on patient reported outcomes assessed by questionnaires. Vertigo symptoms are assessed by the Dizziness Handicap Inventory questionnaire. Patients' quality of life is assessed by a questionnaire. Body sway is assessed by static posturography. FD patients are additionally tested for depressive and anxiety symptoms by questionnaires. BVP patients are additionally tested for vestibular function by video head impulse test and caloric testing. Adverse events and other observations related to safety (physical examination and vital signs) are evaluated. Vertigo is a common symptom with significant adverse effects on patients' quality of life. Regardless of the exact cause of vertigo attacks, it is important to reduce the frequency, intensity, and duration of vertigo attacks with an effective medication that has no or minimal adverse effect. Vertigoheel®, a natural medicinal product consisting of four ponderable active ingredients, is approved in Germany as treatment for vertigo of various origins. However, no systematic data are available for Vertigoheel® regarding patient-reported outcomes in BVP and FD as the most accepted endpoint in vertigo studies.

NCT ID: NCT05896761 Completed - Clinical trials for Human Immunodeficiency Virus Type 1 (HIV-1)

A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

This sub-study will assess the pharmacokinetics (PK), safety, tolerability, virologic efficacy and health outcomes of CAB (GSK1265744) and RPV long acting (LA) in HIV-infected adult participants currently enrolled in the Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS2M [A2M]) study (NCT03299049).

NCT ID: NCT05892341 Completed - Diabetic Foot Clinical Trials

AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period

Start date: December 5, 2022
Phase: N/A
Study type: Interventional

Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing

NCT ID: NCT05890794 Completed - Hypophosphatasia Clinical Trials

Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia

Start date: May 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to compare the effectiveness of two doses of ilofotase alfa, an enzyme replacement treatment, in patients with hypophosphatasia (HPP). The main question it aims to answer is if the harmful accumulating levels of extracellular inorganic pyrophosphate (PPi) and pyridoxal 5'-phosphate (PLP) can be reduced with ilofotase alfa. Researchers will compare the two doses of ilofotase alfa to see if treatment effects differ between the doses.

NCT ID: NCT05885620 Completed - Alzheimer Disease Clinical Trials

SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia

SAIN_UMR
Start date: November 10, 2020
Phase: N/A
Study type: Interventional

Assistive Technologies (ATs) can help people living with dementia (PwD) maintain their everyday activity. Still, there is a gap between potential and supply. Involving future users can close the gap. But the value of participation from PwD is unclear. The study examined smartwatch interactions from people with dementia or with mild cognitive impairment. Participants received "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts on a customized smartwatch to perform everyday tasks. Participants' reactions were observed via cameras. Users' feedback was captured with questionnaires.

NCT ID: NCT05883124 Completed - Bioequivalence Clinical Trials

Rivastigmine Bioequivalence Trial With Multiple Applications of Transdermal Patches (9.5 mg/24 h)

Start date: April 17, 2023
Phase: Phase 1
Study type: Interventional

The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the marketed Test product Rivastigmine twice-weekly 9,5 mg/24 h transdermal patch (Manufacturer: Luye Pharma AG, Germany) and the marketed Reference product Exelon® 9.5 mg/24 h transdermal patch (Manufacturer: LTS Lohmann Therapie-Systeme AG, Germany) after multiple patch applications. Each of both treatments will last for 11 days with a washout period of at least 14 treatment-free days between the treatments.