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NCT ID: NCT04453475 Completed - Anxiety Clinical Trials

Feasibility and Benefits of Digital Services During the COVID19 Pandemic

AnhandCOV19
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time. How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care? What are support measures to encourage social participation and return to work?

NCT ID: NCT04451772 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide. Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study. Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04451187 Completed - Clinical trials for Depressive Disorder, Major

A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressive Disorder

Start date: July 16, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the effect of seltorexant, compared to placebo, as an add-on medication to an antidepressant, on next-day driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test in participants with major depressive disorder (MDD).

NCT ID: NCT04450407 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Study of LY3209590 in Participants With Type 1 Diabetes

Start date: July 6, 2020
Phase: Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.

NCT ID: NCT04450394 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Start date: July 1, 2020
Phase: Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.

NCT ID: NCT04450290 Completed - Clinical trials for Hearing Loss, Sensorineural

Dexamethasone-Eluting Cochlear Implant Electrode

CIDEX
Start date: June 30, 2020
Phase: N/A
Study type: Interventional

A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma. The aim of this clinical investigation is to obtain a first experience in use of the investigational device in the adult clinical population, and to initially assess tools, techniques and performance outcome measures that may be considered in future clinical studies of similar devices.

NCT ID: NCT04450238 Completed - Depression Clinical Trials

The Dual Factor Model of Mental Health in Inpatients

Start date: July 18, 2017
Phase:
Study type: Observational

The Dual Factor Model of mental health (DFM; Greensporn & Saklofske, 2001) postulates that mental health consists of two at least partially unrelated factors, the experience or absence of psycho-pathological symptoms (i.e. depressive symptoms) and the experience or absence of positive mental health (i.e. life satisfaction, meaningfulness). Both factors contribute to an individual's well-being and mental health.The DFM has been used as a framework to describe and evaluate participants' mental health in different settings in cross-sectional and longitudinal designs mostly outside of clinical settings. Psychological Interventions, such as cognitive-behavioral therapy are widely studied concerning their reduction of psycho-pathological symptoms. However, little is known about the effect of psychological interventions on the second factor (positive mental health) of the DFM. This is especially important, because the latter has been shown to contribute significantly to subjective well-being and to reduce the risk of suicidal intentions and behavior. Primary, the authors aim to investigate the DFM in an inpatient sample over the course of time (pre-treatment, post-treatment, 6 and 12 months after discharge). Secondly, they aim to investigate the relationship between positive mental health and suicidal ideation over the course of time.

NCT ID: NCT04449276 Completed - COVID-19 Clinical Trials

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19

Start date: June 18, 2020
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.

NCT ID: NCT04449029 Completed - Hepatitis B Clinical Trials

A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)

B-Clear
Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B virus surface antigen (HBsAg) less than (<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) <LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In addition, the study will also evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB; participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be randomized into one of the 4 different parallel arms to receive treatment. The study will consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440 participants will be enrolled in the study.

NCT ID: NCT04448574 Completed - Funnel Chest Clinical Trials

Chest Wall Deformities in Children - Epidemiological Data

Start date: September 1, 2019
Phase:
Study type: Observational

Pectus excavatum (PE) or funnel breast is the most common congenital deformity of the chest wall, which occurs in about 1 in 400 births with a boy to girl ratio of 4: 1 to 3: 1. The etiology of PE is largely undefined, but there are numerous indications that genetic factors play a role in the development of PE. Up to 40% of patients report affected family members with similar congenital deformities. In many families, PE follows a pattern that would be compatible with an autosomal dominant or recessive pattern of inheritance. The data on the frequent occurrence of PE in family members fluctuate greatly and only a few genes associated with a PE have been identified so far.