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NCT ID: NCT04165668 Terminated - Clinical trials for Stress, Psychological

Wellbeing and Stress Among Mobile Phone Dispatched Lay Responders

Start date: January 9, 2019
Phase:
Study type: Observational

The aim of this study is to provide detailed information on state of mind, psychological wellbeing and stress for lay responders dispatched to suspected OHCA via a mobile phone application. The Heartunner system is a mobile phone positioning system for dispatch of CPR-trained lay volunteers to nearby suspected out-of-hospital cardiac arrests (OHCAs). After downloading of a mobile phone application (The Heartrunner application), and given consent of participation, the lay responders are dispatched to nearby suspected OHCA. The lay responders are either dispatched directly to the scene of the suspected OHCA to perform CPR, or to fetch the nearest AED. The location of the OHCA and available AEDs are displayed on a map, facilitated by the Heartrunner application. The Heartrunner system is studied through "The SAMBA-trial" on clinical outcomes for OHCA patients (ClinicalTrials.gov Identifier: NCT02992873). The psychological effects among the lay responders will be evaluated with an online survey adjacent to dispatch and after 4-6 weeks. The results of the survey will be compared both intra-individual, and to a control group of not dispatched lay responders within the Heartrunner system. Descriptive statistics regarding interventions, age, gender and former experience will also be presented.

NCT ID: NCT04149574 Terminated - Clinical trials for Urinary Bladder Neoplasms

A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

CheckMate 7G8
Start date: January 15, 2020
Phase: Phase 3
Study type: Interventional

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

NCT ID: NCT04147000 Terminated - Depression Clinical Trials

Pharmacokinetics and Pharmacodynamics of Oral Sertraline Before and After Bariatric Surgery

ANTILOP
Start date: January 1, 2020
Phase:
Study type: Observational

Volunteers with a prescription of oral sertraline who have been scheduled to bariatric surgery in either Norrköping/Sweden or Lindesberg/Sweden will be asked to participate in a observational study. The aim of this study is to evaluate the absorption and the effect and side effects of sertraline in volunteers 8 weeks before and 1, 6 and 12 months after bariatric surgery.

NCT ID: NCT04117568 Terminated - Sepsis Clinical Trials

The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients

Start date: September 4, 2019
Phase:
Study type: Observational

Surgical trauma elicits an immune response aiming to initiate healing and remove debris and damaged tissue locally at the wound site (1). This local reaction includes a considerable production of cytokines and chemokines that enters the circulation and initiate a systemic inflammatory response mediated by circulating cytokines and chemokines. This response is called systemic inflammatory immune response (SIRS) and is an aseptic systemic inflammation. Postoperative inflammation produces proinflammatory cytokines, mainly IL-6, IL1 beta, and tumor necrosis factor alfa (2). Neutrophils and emergency granulopoesis Polymorphonuclear neutrophils constitute the most abundant population of white blood cells. Their main task is to provide innate immune protection of the host from microbial attack, migrating to the site of infection, engulfing the microbes by phagocytosis, and killing the prey through attack by reactive oxygen species (ROS) and antimicrobial granule pro¬teins (22). Upon systemic infection or inflammation, e.g., sepsis or trauma, the bone marrow enters a state of emergency granulopoiesis, drenched in cytokines that augment production and survival of neutrophils for rapid delivery to the blood (23-25). Recently, advanced techniques have evolved that al¬low the isolation of different developmental stages of steady-state and emergency neutrophils, and characterization of these has just begun (26). Glycans Glycans (polysaccharides) attached to proteins and lipids on the surfaces on immune cells serve as ligands for glycan-binding proteins, lectins. Several neutrophil processes are directed by gly¬can - lectin interactions; selectin-directed rolling on the endothelium, siglec-mediated in¬hibitory signals, and activation of effector function by galectins. Many of the proteins that end up in neutrophil intra-cellular granules are highly glycosylated, but not much is known about if and how the neutrophil glycome evolves during the 'targeting-by-timing' process of differentiation and how this is affected by emergency granulopoiesis during systemic infection and inflammation. Here is a clear knowledge gap.

NCT ID: NCT04099888 Terminated - Cholangiocarcinoma Clinical Trials

PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer

RELEASE
Start date: May 23, 2019
Phase: Phase 2
Study type: Interventional

This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable.

NCT ID: NCT04079491 Terminated - Oral Lichen Planus Clinical Trials

Intra and Extra Oral Inspection of Oral Mucosa

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

Dental health professionals have a responsibility to perform routine intra- and extraoral inspection on their patients for detecting abnormalities. As dental hygienists (DH) and dentist (D) often see their patients on a regular basis, they have the opportunity to provide this screening, and at an early stage detect abnormalities.

NCT ID: NCT04067180 Terminated - Clinical trials for Acute Myeloid Leukemia

Randomized Clinical Study Assessing Haplo vs. URD in AML

Start date: November 12, 2019
Phase: N/A
Study type: Interventional

This study compares haplo-identical family donor stem cell transplantation (haplo SCT) to matched unrelated donor transplantation (URD SCT) in adult patients with acute myeloid leukemia (AML) with the hypothesis that haplo SCT is as good as URD SCT. Background: A haplo-identical family donor is a relative sharing 50% of the human leukocyte antigens (HLA) of the patient. SCT with this type of donor is increasing, and a number of retrospective studies have demonstrated its feasibility, but prospective randomized studies are still lacking. Such studies are necessary to establish the benefits of haplo SCT. For the ≈70% of the patients that lack the 1st choice donor, an HLA-matched sibling, the 2nd choice is an URD at most centers. However, if haplo-identical donors are as good as URDs, this could change. Haplo-identical donors have several advantages. Almost all patients have at least one available haplo-identical donor, while URDs can be difficult to find. It also eliminates the need for time-consuming donor searches, and is considerably less costly. The Study: Patients can be included in the study if they have AML and require SCT, ≥18 years, DO NOT have an HLA-matched sibling donor, and DO have potential haplo-identical family donors AND URDs. After enrollment in the study, the patients are assigned randomly to either haplo SCT or URD SCT. The treatment surrounding the transplantation differs according to the donor type. Patients receiving haplo-identical transplantation are treated with a specified chemotherapy protocol before transplantation and a chemotherapy combined with immunosuppressive drugs after the transplantation to prevent graft-vs. host disease (GVHD). The patients receiving URD SCT will be treated according to the standard protocol at their center. Thus, haplo SCT will be compared to what is currently used in patients without an HLA-identical sibling today. The primary endpoint of this study is graft-vs.-host disease- and relapse free survival two years after study inclusion. This measurement takes into account the side effect that causes the most long-term suffering, graft-vs-host disease, as well as leukemia relapse and thus indicates to what extent the treated patients remain relapse-free and without significant side effects. Secondary end points include relapse-free survival, frequencies of graft-versus-host disease and of infections, and the patients will be followed in the study for five years.

NCT ID: NCT04065568 Terminated - Clinical trials for Stroke Rehabilitation

An Interactive Distance Solution for Stroke Rehabilitation in the Home Setting

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Equal access to evidence based rehabilitation in the stroke population is a challenge. Home based solutions including telerehabilitation is a promising strategy to meet these needs. However, the tools must be customized for persons with stroke and the technologies developed to serve rehabilitation purposes. The DISKO-tool was developed to enable efficient, continuous training in the home setting with health professional follow ups of training and training results after stroke via video link. The tool has in a preliminary study proved feasible and safe in different phases after stroke. The functional effect of using the DISKO-tool added to conventional rehabilitation in the home setting is yet to be explored. Thus, the aim of this study is to explore the added value of using the DISKO-tool during rehabilitation in the home setting.

NCT ID: NCT04059094 Terminated - Cystic Fibrosis Clinical Trials

A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1

Start date: September 16, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic fibrosis.

NCT ID: NCT04056611 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

FREESIA
Start date: December 26, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.