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NCT ID: NCT06314841 Terminated - Wounds and Injuries Clinical Trials

Polytrauma and Resuscitation Impact on Innate Immunity

PRIME
Start date: June 1, 2017
Phase:
Study type: Observational

Major trauma can lead to a dysregulated response to secondary infection. Severe injuries are accompanied by pro- and antiinflammatory changes that affect both adaptive and innate immunity. In this study we aim to assess cellular immuno-competence early during treatment in an attempt to identify signs of immuno-suppression.

NCT ID: NCT05895253 Terminated - Unilateral Clinical Trials

Safety and Efficacy of Vibro-tactile Feedback for Patients Who Underwent Lower Limb Amputation

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

Prosthetics research has grown recently, focusing on bionic approaches that restore bodily functions with technical aids. One method involves using prostheses with feedback systems, which measure physical parameters and provide additional information to the user. Saphenus has developed a feedback system called Suralis© that transfers pressure signals from the prosthetic sole to another body region. This clinical investigation aimed to determine if this system improves gait stability and walking. The study analyzed changes in gait and functional balance and gathered patient-reported measures to evaluate the quality of life. This research was open to individuals who have undergone below-knee amputation but no targeted re-innervation surgery and use prosthetics. Participants received the Suralis© feedback system, and the investigators assessed their walking activities. The system measures prosthetic foot sole pressure and converts it into digital signals, triggering vibration stimuli during the stance phase of walking. The investigators collected gait analyses and patient feedback to assess the impact of the feedback system on prosthetic management. The results will help us understand the benefits and effectiveness of this technology for people with amputation.

NCT ID: NCT05643573 Terminated - Atrial Fibrillation Clinical Trials

A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

OCEANIC-AF
Start date: December 5, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: - how long asundexian works well and - how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: - stroke and/or - systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health. The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months. Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected locations. The location name contains the abbreviation - DCT in such cases. During the study, the study team will: - take blood samples - do physical examinations - examine heart health using an electrocardiogram (ECG) - check vital signs such as blood pressure and heart rate - do pregnancy tests - ask the participants questions about their quality of life - 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 that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05639192 Terminated - COVID-19 Clinical Trials

Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease

ASUCOV
Start date: November 3, 2022
Phase: Phase 3
Study type: Interventional

This clincial trial is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial in hospitalized patients with moderate to severe COVID-19 corresponding to score 5 or 6 on the WHO 10-point clinical progression scale (Grade 0-10). The investigational drug (APG101; International Nonproprietary Name: asunercept) will be given at a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1 dose each on d1, d8, d15, and d22) in addition to the treatment recommended by international, national, or local treatment guidelines (SoC) and will be compared with the control arm (i.e., SoC + placebo).

NCT ID: NCT05142540 Terminated - Clinical trials for Anti-SARS-CoV-2 Antibody Response

Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines

CoVVacBoost
Start date: December 1, 2021
Phase:
Study type: Observational

The investigators aim to evaluate the ability of a COVID-19 (Coronavirus disease) booster vaccine to induce a salivary antibody response and investigate a possible correlation with the serum antibody response and the cellular response. The investigators will conduct a prospective single center cohort study including fully vaccinated probands.

NCT ID: NCT05116228 Terminated - Clinical trials for Rheumatoid Arthritis

Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission

REDOREM
Start date: September 1, 2015
Phase: Phase 4
Study type: Interventional

To investigate whether a reduced-dose dosing regimen (1x500mg semiannually) of rituximab (RTX) (Mabthera®) is non-inferior in patients with rheumatoid arthritis (RA) whose disease is in persistent low disease activity (LDA) or clinical remission (REM) (pLDA/pREM) as compared to the standard dosing regimen of 1x1000mg semi-annual infusions.

NCT ID: NCT05083078 Terminated - Healthy Clinical Trials

A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis

Start date: November 4, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2 and Part 3).

NCT ID: NCT05079230 Terminated - Clinical trials for Acute Myeloid Leukemia

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

ENHANCE-3
Start date: July 7, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.

NCT ID: NCT05068284 Terminated - Crohn's Disease Clinical Trials

A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease

AIM-CD
Start date: January 31, 2022
Phase: Phase 2
Study type: Interventional

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide. The study is compromised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during 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: NCT05053789 Terminated - Eye Diseases Clinical Trials

Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine in Moderate-to-severe Dry Eye Disease

Start date: May 12, 2021
Phase: N/A
Study type: Interventional

Aim of this pilot study is to evaluate the best treatment regime of Chitosan-N-Acetylcysteine (Lacrimera®) compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).