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NCT ID: NCT05051995 Not yet recruiting - Depressive Symptoms Clinical Trials

Combined N-of-1 Trials to Assess Open-Label Placebo Treatment for Antidepressant Discontinuation Symptoms

FAB
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

It has been widely recognized that the placebo effect has a profound impact on treatment outcome in many different conditions. Recent studies imply that this effect appears even if placebos are openly administered; so called "open-label placebos" (OLP). Compelling evidence suggests the efficacy of OLP in the treatment of pain disorders, neuropsychological syndromes, menopausal hot flushes, depression and allergic rhinitis. Research on the underlying mechanisms of OLP is scarce, yet studies indicate that psychological mechanisms as well as neurobiological processes related to expectation- and prediction mechanisms may play a role. While these effects have been linked to OLP as additional treatment, to date, it has not been examined whether OLP could support discontinuation of drug treatments. Antidepressant discontinuation has been frequently associated with negative side effects, interfering with the discontinuation process and generally discouraging discontinuation. Patients frequently report negative expectations towards the discontinuation process, such as fear of experiencing a relapse and negative side effects. Interestingly, OLP may support antidepressant discontinuation, not only through the generation of (positive) expectations, but also mechanisms related to habituation (i.e. taking pills). The objective of this study is to investigate whether OLP is efficacious in reducing negative side effects caused by discontinuation of antidepressant medication.

NCT ID: NCT05051904 Not yet recruiting - Clinical trials for Coronary Artery Disease

A Study Based on Japanese Medical Records That Looks at Bleeding Events in People With Atrial Fibrillation and Coronary Artery Disease Who Start Taking Either Dabigatran, Rivaroxaban, or Warfarin

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

The study aims to evaluate the safety and effectiveness comparisons between warfarin, dabigatran, and rivaroxaban in routine clinical practice among Japanese non-valvular atrial fibrillation (NVAF) patients with concomitant coronary artery disease (CAD).

NCT ID: NCT05051098 Recruiting - Clinical trials for Hepatitis B Virus Infection

A Non-interventional Registry for Patients With Hepatitis B Virus Infection

Start date: May 6, 2021
Phase:
Study type: Observational [Patient Registry]

In order to tackle the unmet needs in chronic HBV infection, a consortium of clinical partners has gathered to establish a registry for patients with hepatitis B mono- and co-infections. The partners will build up a European-wide registry to be able to stratify patients for upcoming clinical trials. Extensive analyses of virus and host-specific parameters are to be carried out from these patients. The knowledge gained thereby should contribute to a better understanding of the HBV control and enable patient stratification with regard to immunomodulatory therapies. Furthermore, hepatitis B patients are to be identified who are willing to participate in future studies to investigate immunotherapies to cure HBV infections (e.g. therapeutic vaccines).

NCT ID: NCT05049915 Recruiting - Clinical trials for Pseudoarthrosis of Bone

Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Tibia and Femur Non-unions

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Abstract Background: Treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. Therefore, artificial bone graft substitutes that might replace autologous bone are needed. S53P4-type bioactive glass (BaG) is a promising material which might be used as bone graft substitute due to its osteostimulative, conductive and antimicrobial properties. In this study, the investigators plan to examine the clinical effectiveness of BaG as a bone graft substitute in Masquelet therapy in comparison with present standard Masquelet therapy using an ABG with tricalciumphosphate to fill the bone defect. Methods/design: This randomized controlled, clinical non-inferiority trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University. Patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2-5 cm and who are receiving Masquelet treatment will be included in the study. The resulting bone defect will either be filled with autologous bone and tricalciumphosphate (control group, N = 25) or BaG (S53P4) (study group, N = 25). Subsequent to operative therapy, all patients will receive the same standardized follow-up procedures. The primary endpoint of the study is union achieved 1year after surgery. Discussion: The results from the current study will help evaluate the clinical effectiveness of this promising biomaterial in non-union therapy. In addition, this randomized trial will help to identify potential benefits and limitations regarding the use of BaG in Masquelet therapy. Data from the study will increase the knowledge about BaG as a bone graft substitute as well as identify patients possibly benefiting from Masquelet therapy using BaG and those who are more likely to fail, thereby improving the quality of non-union treatment.

NCT ID: NCT05049798 Recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

PsABIOnd
Start date: August 25, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

NCT ID: NCT05048758 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Adverse Childhood Experiences in Alcohol Use Disorder

Start date: September 2021
Phase:
Study type: Observational

Adverse childhood experiences (ACE) and their relation to the development of an alcohol use disorder (AUD) will be measured with fMRI.

NCT ID: NCT05048355 Completed - Amputation Clinical Trials

Metabolic Cost of Walking With Passive vs. Powered Microprocessor Controlled Knees

Start date: May 26, 2021
Phase: N/A
Study type: Interventional

This study is conducted to evaluate the efficacy of the Power Knee Mainstream Dynamic compared to passive microprocessor-controlled knees (MPKs) regarding metabolic cost for high active transfemoral amputees.The test is of a single group repeated measures crossover design. The primary endpoint is the difference in MET/HRI-VO2 index between conditions. Subjects are measured on their prescribed device at visit 1, be fitted to the PKM which they wear as their primary prosthesis for one week before coming for visit 2 and being measured again on the PKM.

NCT ID: NCT05048004 Not yet recruiting - Atrial Fibrillation Clinical Trials

Cerebral Embolization During Pulmonary Vein Isolation

TCD-CA
Start date: September 2021
Phase:
Study type: Observational

The goal of the TCD-CA study is to determine the frequency of cerebral embolization during pulmonary vein isolation using continuous transcranial Doppler examination. Different parts of the procedure, different ablation techniques and periprocedural anticoagulation regimes will be compared.

NCT ID: NCT05047029 Completed - Portal Hypertension Clinical Trials

Myocardial Fibrosis and Inflammation in Liver Cirrhosis

Start date: November 2, 2018
Phase:
Study type: Observational

The aim of this clinical prospective study is to assess structural and functional myocardial changes in patients with liver cirrhosis after implantation of transjugular intrahepatic portosystemic shunt (TIPS).

NCT ID: NCT05046873 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People

Start date: September 6, 2021
Phase: Phase 1
Study type: Interventional

In this study, participants will receive semaglutide and NNC0480-0389 together at the same time. Semaglutide is a medicine that can already be prescribed, whereas NNC0480-0389 is a new potential medicine. Giving the medicines at the same time will be investigated once by using two separate syringes and once by using only one syringe containing both medicines ("co-formulation"). The co-formulation will be given together with an injection of placebo. Both medicines are tested for the treatment of type 2 diabetes. Giving the two complementary medicines at the same time is intended to lower blood sugar in people with type 2 diabetes. NNC0480-0389, in combination with semaglutide, is already being investigated in an ongoing human clinical study. The aim of this study is to compare the amount of medicine (semaglutide and NNC0480-0389) in the blood: after participants received the medicines at the same time (0.5 mg semaglutide and 5 mg NNC0480-0389) using only one syringe (co-formulation)after participants received the medicines separately using two syringes. For this purpose, the amount of semaglutide and NNC0480-0389 in the blood will be measured after participants received the medicines in co-formulation and after participants received the medicines using separate syringes. There will be two treatment periods: One period where participants receive the two medicines as two separate injections and another period where participants receive the two medicines in one injection (co-formulation), together with an injection of placebo. It will be randomly determined in which order participants will receive the 2 treatments (separate injections first or co-formulation first). For both treatments the study medicines will be injected into a skin fold in the left and right stomach using a thin needle.Giving the medicines in the two treatment periods will take place at an interval of at least 8 weeks. The study can last for up to 19 weeks for each participant. This includes a screening period (up to 4 weeks), two treatment periods (5 weeks each) and a washout period (3 - 5 weeks). The washout period ensures that the given treatments and their effects have disappeared from the body. Participants will not receive any study medicines during this time. Participants will have 21 clinic visits. Some of the visits include overnight stays. Participants will have blood tests at every clinic visit. For 4 visits (Visits 2, 11, 12 and 21; Day 1 and 36 of each period) participants must not have had any food or drink (water is allowed) for up to 8 hours before participantsr body weight is measured. Participants must be healthy and have a body mass index (BMI) between 20.0 and 29.9 kg/m2. If participants are a woman participants can only take part in this clinical study, if participants cannot get pregnant, for example, after menopause. A hormone test will be done to confirm this.