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NCT ID: NCT05233553 Completed - COVID-19 Clinical Trials

SSC-COVID in Patients After COVID-19

Start date: March 1, 2020
Phase:
Study type: Observational

Analysis of occurrence of SSC-COVID in SARS-CoV-2-patients after the first wave of COVID-pandemic

NCT ID: NCT05233306 Completed - Tourette Syndrome Clinical Trials

Investigations of the Pathophysiology of Gilles de la Tourette Syndrome. Part 2: 7T MRI

Start date: January 27, 2022
Phase:
Study type: Observational

Gilles de la Tourette syndrome (GTS; also known as Tourette syndrome) is a congenital neuropsychiatric disorder. Characteristic symptoms are so-called tics-rapid, repetitive movements (motor tics) or vocalizations (vocal tics) that start suddenly without any apparent purpose. Previous research supports the hypothesis of defective regulation (dysregulation) of the dopaminergic system, with particular discussion of dysfunction of tonic/phasic dopamine release or dopaminergic hyperinnervation. Moreover, given the complex interaction of different neurotransmitters, especially in the basal ganglia, it can be assumed that abnormal dopaminergic transmission also affects other transmitter systems, such as glutamate (Glu) or γ-aminobutyrate (GABA). Furthermore, recent results suggest an abnormality in cerebral iron metabolism in GTS. Since iron is accumulated in dopamine vesicles and plays a central role in dopamine synthesis, this observation may also be related to dysfunction of the dopaminergic system. Therefore, in this multimodal study, the investigators aim to combine positron emission tomography (PET), magnetic resonance imaging (MRI), and magnetic resonance spectroscopy (MRS) methods comparing patients with GTS and a control cohort. In Part 2 of this study, MRI and MRS at 7 Tesla are employed to investigate (i) the concentrations of Glu, glutamine and GABA in the corpus striatum and the cortex cingularis anterior and (ii) the subcortical iron concentration.

NCT ID: NCT05232955 Completed - Tourette Syndrome Clinical Trials

Investigations of the Pathophysiology of Gilles de la Tourette Syndrome. Part 1: Simultaneous PET and 3T MRI

Start date: May 4, 2022
Phase:
Study type: Observational

Gilles de la Tourette syndrome (GTS; also known as Tourette syndrome) is a congenital neuropsychiatric disorder. Characteristic symptoms are so-called tics-rapid, repetitive movements (motor tics) or vocalizations (vocal tics) that start suddenly without any apparent purpose. Previous research supports the hypothesis of defective regulation (dysregulation) of the dopaminergic system, with particular discussion of dysfunction of tonic/phasic dopamine release or dopaminergic hyperinnervation. Moreover, given the complex interaction of different neurotransmitters, especially in the basal ganglia, it can be assumed that abnormal dopaminergic transmission also affects other transmitter systems, such as glutamate (Glu) or γ-aminobutyrate (GABA). Furthermore, recent results suggest an abnormality in cerebral iron metabolism in GTS. Since iron is accumulated in dopamine vesicles and plays a central role in dopamine synthesis, this observation may also be related to dysfunction of the dopaminergic system. Therefore, in this multimodal study, the investigators aim to combine positron emission tomography (PET), magnetic resonance imaging (MRI), and magnetic resonance spectroscopy (MRS) methods comparing patients with GTS and a control cohort. In Part 1 of this study, MRI and MRS at 3 Tesla are employed to investigate (i) the binding potential of D1 dopamine receptors, (ii) the concentrations of Glu, glutamine and GABA in the corpus striatum and the cortex cingularis anterior and (iii) the subcortical iron concentration.

NCT ID: NCT05227365 Completed - Tinnitus Clinical Trials

Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3

TENT-A3
Start date: March 21, 2022
Phase: N/A
Study type: Interventional

TENT-A3 is a single arm repeated measures prospective investigation evaluating the safety and efficacy of the Lenire device for tinnitus treatment. The Lenire device provides non-invasive bimodal (sound and tongue) stimulation to alleviate the symptoms of chronic, subjective tinnitus. Participants presenting to one of the several study sites with a diagnosis of chronic subjective tinnitus who meet the inclusion criteria are enrolled in the investigation while the study site is active. The objective of TENT-A3 is to determine whether the addition of tongue stimulation to sound-only stimulation provides additional clinically significant improvements in tinnitus symptoms beyond that of the sound-only stimulation component of the bimodal treatment.

NCT ID: NCT05223868 Completed - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis

FRONTIER 1
Start date: February 3, 2022
Phase: Phase 2
Study type: Interventional

Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

NCT ID: NCT05222152 Completed - Clinical trials for Primary Adrenal Insufficiency

Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency

CHAMPAIN
Start date: November 23, 2021
Phase: Phase 2
Study type: Interventional

This study is a double-blind, double-dummy, two-way cross-over, randomised, Phase II study to be conducted at approximately 6 investigational sites in 2 countries. The study will compare the efficacy, safety and tolerability of twice daily Chronocort, a modified-release hydrocortisone, with once daily Plenadren, a modified-release hydrocortisone, over a treatment period of up to 2 months in participants aged 18 years and over, diagnosed with primary Adrenal Insufficiency (AI).

NCT ID: NCT05219812 Completed - Diabetes Mellitus Clinical Trials

A Study to Learn How Safe BAY2395840 is and How Well it Works in Participants Who Have Diabetic Nerve Pain

Start date: February 16, 2022
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP), a condition in which diabetes results in pain due to nerve damage. People with diabetes have high blood sugar levels. Over the time, high blood sugar levels can cause damage to the nerves in the body, which results in DNP. The nerve damage in this condition is localized in a stocking and glove like pattern and starts in the feet and can move upwards on your legs. Some patients also progress having pain in their fingers/hands. People with DNP have pain in these areas as well as reduction/loss of feeling, and at times light touch can feel like pain. In this study, the researchers want to learn more about a new study treatment called BAY 2395840. BAY 2395840 works by blocking a receptor called the bradykinin B1 receptor, or B1R. This receptor is has been shown to play a role in pain perception. The researchers also want to learn how well BAY 2395840 helps to reduce pain in the study participants. To answer this question, the researchers will measure how the participants' pain changes after taking BAY 2395840 compared to a placebo. A placebo looks like a treatment but does not have any medicine in it. The researchers also want to learn how safe BAY 2395840 is for the participants to take. The study will include adults. This will be a "crossover" study. In a crossover study, all the participants will receive both treatments (BAY 2395840 and placebo), but in a different order. All participants in this study will take BAY 2395840 and a placebo as tablets by mouth. There will be 2 periods in the study. Participants taking BAY 2395840 during period 1 will switch to placebo during period 2 and vice versa. There will some time for the switch from one period to another to make sure that whatever tablet you received in period 1 is gone from your system before period 2 starts to allow for the best possible evaluation of each tablet without any confusing effects. The study is double blinded meaning that neither you nor your doctor will know which drug you are on. The sequence of double-blind placebo and BAY treatment will be determined randomly by a computerized system. During the study, the participants will visit their study site 13 times. Each participant will be in the study for about 16 weeks. The treatment duration will be about 11 weeks. During the study, the study team will: - take blood and urine samples - do physical examinations - check the participants' overall health - check the participants' heart health using an electrocardiogram (ECG) - ask the participants about any medications they have been taking, 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 that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05219526 Completed - Diabetes Mellitus Clinical Trials

System Accuracy of 12 Bloog Glucose Monitoring Systems

Start date: January 3, 2022
Phase: N/A
Study type: Interventional

The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.

NCT ID: NCT05214560 Completed - Anesthesia Clinical Trials

Prospective Clinical Evaluation of BD Spinal Needles

Start date: February 10, 2022
Phase:
Study type: Observational

Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.

NCT ID: NCT05213481 Completed - Healthy Clinical Trials

Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants

Start date: December 15, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study was to assess the effect of multiple doses of carbamazepine on single- dose tepotinib pharmacokinetics in healthy participants. Study details include: Study Duration: up to about 10 weeks; Treatment Duration: single dose of tepotinib on Days 1 and 26, 25 days of treatment with carbamazepine (Days 8 to 32); Visit Frequency: residence in the Clinical Research Unit from Days -1 to 4 and Days 25 to 29, ambulatory daily visits from Days 5 to 24 and 30 to 33, and one ambulatory visit on Day 39.