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NCT ID: NCT06363786 Not yet recruiting - Clinical trials for Incontinence-associated Dermatitis

Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and qPCR. In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of pathces. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with approproate statistical tests on 5% level for varaibles. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed.

NCT ID: NCT06363435 Recruiting - Prostate Cancer Clinical Trials

AI-based Measurements of Tumour Burden in PSMA PET-CT

Start date: March 29, 2024
Phase:
Study type: Observational

The primary aim of the present study is to evaluate how automatically calculated (by an AI-based method) tumour burden, measured as tumour volume (TV) and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence).

NCT ID: NCT06363396 Recruiting - Fatigue Clinical Trials

Fatigue and Cognitive Dysfunction After Allogeneic Stemcell Transplantation, Prospective PET Study

Start date: February 22, 2024
Phase:
Study type: Observational

This study is the academic study and continuation and further development of a prior project under the leadership of Professor LeBlanc. Patients undergoing allogenic stem cell transplantation are followed up in the outpatient clinic. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Previous study by Boberg et al suggested distinct mRNA and proteomic profiles segregating fatigued from non-fatigued patients as well as patients with or without cognitive impairment. A larger well-defined patient cohort is necessary to confirm these results. Investigators aim to identify specific sets of proteins in the CSF that can serve as potential biomarkers of cognitive dysfunction and/or fatigue. This will be performed with two methods: - by using mass spectrometry-based proteomics approaches - Olink technology PET examinations will be performed on both fatigued and non-fatigued. We will utilize the second generation TSPO radioligand [ 11C]PBR28 as well as the SV2A radioligand [ 11C]UCB-J, both showing high signal-to-noise ratio and adequate test-retest properties.

NCT ID: NCT06360640 Not yet recruiting - Healthy Subjects Clinical Trials

A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults

Start date: June 2024
Phase: Phase 1
Study type: Interventional

The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults.

NCT ID: NCT06356129 Not yet recruiting - Clinical trials for Large B-cell Lymphoma

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

GOLSEEK-1
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

NCT ID: NCT06355245 Recruiting - Cancer Clinical Trials

MEDECA - Markers in Early Detection of Cancer

MEDECA
Start date: March 1, 2018
Phase:
Study type: Observational

Early diagnosis of cancer is key for improving patient outcomes, but cancers are difficult to diagnose if patients present with unspecific symptoms. The principal objective of the MEDECA (Markers in Early Detection of Cancer) study is to identify a multi-analyte blood test that can detect and map occult cancer within a mixed population of patients presenting with serious but unspecific symptoms. The study will include 1500 patients referred to the Diagnostic Center at Danderyd Hospital (DC DS), a multidisciplinary diagnostic center referral pathway for patients with radiological findings suggestive of metastasis without known primary tumor or suspicion of serious but unspecific symptoms. Blood samples are collected prior to a standardized and extensive cancer diagnostic work-up, including an expanded panel of biochemical analyses and extensive imaging such as computed tomography or magnetic resonance investigations. In collaboration with world-leading international scientists, the blood samples will be analyzed for a panel of novel and established blood biomarkers predictive of an underlying cancer, including markers of neutrophil extracellular traps, circulating tumor DNA, platelet mRNA profiling, affinity-based proteomics and nuclear magnetic resonance metabolomics. The diagnostic accuracy of the blood biomarkers with respect to cancer detection during the diagnostic work-up will be analyzed through machine learning.

NCT ID: NCT06352983 Completed - Missing Teeth Clinical Trials

Zirconium Dioxide Fixed Dental Prosthesis.

Start date: December 20, 2017
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to evaluate and compare bridges to replace one or two missing teeth in the mouth. The bridges will be made of two variants of ceramic material. We will evaluate the bridges for up to five years regarding technical and biological complications.

NCT ID: NCT06351618 Recruiting - Sport Injury Clinical Trials

Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking

Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions.

NCT ID: NCT06349668 Recruiting - Renal Cancer Clinical Trials

Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery

SMILe
Start date: April 9, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to learn whether the addition of spinal analgesia leads to superior recovery in patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. The main questions it aims to answer are: - Is the decrease in wellbeing as quantified by the patient-centered outcome scale "Quality of Recovery 15" (QoR-15), from baseline to the first day after surgery (POD 1), at least 8.0 points less in patients receiving spinal analgesia in addition to general anesthesia? - Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications? - Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery? - Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery? Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively. QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary. In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction.

NCT ID: NCT06348355 Recruiting - Healthy Volunteers Clinical Trials

A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers

Start date: April 12, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to measure brain exposure of [11C]savolitinib in healthy volunteers. This study will determine brain exposure of [11C]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when the BBB is intact. The study design allows up to 3 site visits. Two PET examinations will be performed for each healthy volunteer. The first PET examination will use IV administration of [11C]savolitinib. The second PET examination using [11C]savolitinib will occur after a single oral dose of 300 mg of savolitinib. PET image analysis will include kinetic compartment modelling using arterial input function, and will generate a set of brain exposure parameters (eg, maximum %ID, maximum [11C]savolitinib concentration in brain, partition coefficients between brain and plasma).