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NCT ID: NCT04705389 Not yet recruiting - Clinical trials for Merkel Cell Carcinoma

SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines

SUMMERTIME
Start date: September 2021
Phase: N/A
Study type: Interventional

Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion from baseline diagnosis, in a cohort of 150 European MCC patients

NCT ID: NCT04702425 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma)

Start date: June 23, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the study is to identify doses and schedules of VOB560 and MIK665 that can be safely given and to learn if the combination can have possible benefits for patients with Non-Hodgkin lymphoma (NHL), Multiple Myeloma (MM) or Acute Myeloid Leukemia (AML). VOB560 and MIK665 are selective and potent blockers respectively of the B-cell lymphoma 2 (BCL2) protein and of the myeloid cell leukaemia 1 (MCL1) protein, proteins that may protect tumor cells from undergoing cell death. VOB560 and MIK665 are designed to block the functions of the BCL2 and MCL1 proteins, so that the tumor cells that rely on these proteins undergo cell death. Preclinical data suggest that concomitant treatment with VOB560 in combination with MIK665 induces robust anti-tumor activity.

NCT ID: NCT04698200 Active, not recruiting - Type 2 Diabetes Clinical Trials

Type 2 Diabetes, Cardiovascular Comorbidity and Environmental Temperature

DiabColdHeat
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Both high and low environmental temperatures are associated worldwide with higher morbidity and mortality and an estimated 8% of the mortality is estimated to relate to non-optimum temperatures. The majority of the adverse health effects occur at to low, and not high temperatures, and already with a modest change in temperature. Persons with type 2 diabetes can be sensitive to the effect of temperature due to their altered neural, metabolic and circulatory functions. The pathophysiological responses of type 2 diabetes in a cold and hot environment are not known. The aim of the study is to examine how advanced type 2 diabetes (disease progression >10 years) alone, an in conjunction with coronary artery diseases and hypertension affect neural, cardiovascular and metabolic responses in a cold and hot environment. Type 2 diabetes is associated with altered neural regulation, weakened cardiovascular function, structural changes in blood vessels, altered blood constitution and metabolic disturbances. These affect thermoregulation and result in increased susceptibility to cold (lesser heat production, increased heat loss) and heat (lesser sweating and heat loss). The patients are exposed under controlled conditions in a random order to both cold (+10°C) and heat (+44°C) while resting and lightly clothed for 90 min at a time. The exposure itself is preceded by baseline measurements of the parameters of interest, and followed by repeating the same measurements after the exposure. The topic of the research is very relevant due to the worldwide epidemic of type 2 diabetes. Simultaneously, the comorbid conditions associated with diabetes become more common and are related to a higher occurrence of cardiac events. The research information is useful for all individuals with type 2 diabetes in their protection and self-management of the disease, and enabling to maintain functional ability in a cold or hot environment. The research knowledge can be utilized when developing weather warning systems for the identification of susceptible populations. Health care personnel may utilize the research information while advising their patients and for proper care. An increased awareness of the health effects of both low and high temperatures improve the functional ability of individuals and reduced help reducing morbidity and mortality from weather conditions.

NCT ID: NCT04697628 Active, not recruiting - Cervical Cancer Clinical Trials

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

innovaTV 301
Start date: February 22, 2021
Phase: Phase 3
Study type: Interventional

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

NCT ID: NCT04696523 Not yet recruiting - Cerebral Infarction Clinical Trials

Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage

Xe-SAH
Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

An investigator-initiated clinical drug study Main Objective: To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH). Primary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging (DTI). Hypothesis: White matter damage is less severe in xenon treated patients, i.e. global fractional anisotropy is significantly higher in the xenon group than in the control group as assessed with the 1st magnetic resonance imaging (MRI). After confirmation of aSAH and obtaining a signed assent subjects will be randomized to the following groups: Control group: Standard of Care (SOC) group: Air/oxygen and Normothermia 36.5-37.5°C; Xenon group: Normothermia 36.5-37.5°C +Xenon inhalation in air/oxygen for 24 hours. Brain magnetic resonance imaging techniques will be undertaken to evaluate the effects of the intervention on white and grey matter damage and neuronal loss. Neurological outcome will be evaluated at 3, 12 and 24 months after onset of aSAH symptoms Investigational drug/treatment, dose and mode of administration: 50±2 % end tidal concentration of inhaled xenon in oxygen/air. Comparative drug(s)/placebo/treatment, dose and mode of administration: Standard of care treatment according to local and international consensus reports. Duration of treatment: 24 hours Assessments: Baseline data Information that characterizes the participant's condition prior to initiation of experimental treatment is obtained as soon as is clinically reasonable. These include participant demographics, medical history, vital signs, oxygen saturation, and concentration of oxygen administered. Acute data The collected information will contain quantitative and qualitative data of aSAH patients, as recommended by recent recommendations of the working group on subject characteristics, and including all relevant Common Data Elements (CDE) can be applied. Specific definitions, measurements tools, and references regarding each SAH CDE can be found on the weblink here: https://www.commondataelements.ninds.nih.gov/SAH.aspx#tab=Data_Standards.

NCT ID: NCT04695327 Recruiting - Solid Tumor Clinical Trials

TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 Monotherapy

TUNIMO
Start date: January 11, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, phase 1, dose-escalation, multicenter trial evaluating the safety of oncolytic adenovirus TILT-123 as monotherapy in advanced solid tumor patients.

NCT ID: NCT04692259 Recruiting - MRI Clinical Trials

May the Risk of PHLF be Predicted With Preoperative Liver Gadoxetate MRI

MR-Predict
Start date: December 29, 2020
Phase: N/A
Study type: Interventional

Post hepatectomy liver failure (PHLF) is one of the most severe complications after liver re-section. Preoperative evaluation of liver function is complicated and imprecise. The volume and function needed for each individual patient is unknown and the methods used for evaluation are uncertain. Preoperative MRI with Gadolinium may give dynamic information regarding liver function correlating with postoperative liver failure. A retrospective analysis will be performed regarding this topic.

NCT ID: NCT04690907 Completed - Obesity Clinical Trials

Intervention, Dietary, Diabetes, Pregnancy

IDDP
Start date: December 3, 2020
Phase: N/A
Study type: Interventional

The aim of this rct -study is to explore the effect of a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women on gestational weight gain and the prevalence of gestational diabetes.

NCT ID: NCT04690673 Completed - Healthy Clinical Trials

Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

The main objective is to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples. We will recruit 12 healthy volunteers aged 18-45. They will get 1 g oral paracetamol. Paracetamol concentration will be detected from abovementioned samples at timely intervals for 24 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis. Despite of extensive use, the mechanism of action of parasetamol is not completely understood. The central serotonergic system may play a role. Endocannabinoid system is a group of lipid mediators, that possibly is involved in mediating paracetamol effect to the serotonergic system. Serum lipidomic assessment can be used to study endocannabinoid metabolics. In this study we will try to assess changes in endocannabinoid system by looking into serum lipidomics in order to understand the mechanism of action of paracetamol.

NCT ID: NCT04690426 Completed - Clinical trials for Viral; Infection, Coxsackie(Virus)

PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers

PROVENT
Start date: December 14, 2020
Phase: Phase 1
Study type: Interventional

Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.