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NCT ID: NCT05695638 Recruiting - Clinical trials for Haematological Malignancy

Proseq Cancer: Genomic Profiling in Patients With Incurable Cancer in Search for Targeted Treatment

Start date: July 1, 2020
Phase:
Study type: Observational [Patient Registry]

Proseq Cancer is a precision medicine program based on in-house whole exome sequencing (WES) and RNA sequencing. The approved protocol allows for biobanking, registration of clinical and laboratory data, and sharing of genomic data with the purpose of research, while fulfilling the Danish General Data Protection Regulation (GDPR) requirements. Patients are recruited from the North Denmark Region. Treatment can be offered on site if a targeted drug of a nationally approved indication is suggested by the national tumor board (NTB). If not, the patient may be treated in an available clinical protocol. If no approved drug or relevant protocol is available or feasible, treatment with a targeted drug used outside a clinical protocol is pursued.

NCT ID: NCT05694351 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Family-based Prevention of Diabetes Through Eating Habits and Physical Activity

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

Introduction: Type 2 diabetes represents a growing health risk for the society. An easy-access and low-cost intervention for the whole family will be developed to help families with (at risk of) type 2 diabetes maintain diabetes-frendly everyday life. The intervention will be tested for feasibility. Methods: Following the framework for developing and conduct of complex interventions, the intervention will be developed on the basis of current evidence on family-based diabetes treatment and opinions of families with type 2 diabetes. The feasibility test will have embedded mixed methods one-group study design. Participants: Families will answer a brief screening questionnaire. Families (n=25) that consist of at least one adult with (in risk of) type 2 diabetes living in the same household with at least one 5-18 yeard old child, and at least one family member living sedentary lifestyle, will participate. Intervention: The 3-months long hybrid telehealth/face-to-face intervention with weekly 1-hour contacts with health professionals will deliver diabetes education and tailored support to implement more physical activity and healthy meals in the family everyday life. A 3-months long supervised maintenance phase with monthly professional contacts will be included. Outcomes: Feasibility evaluation will be conducted using quantitative (quantifiable) and qualitative research methods. The feasibility data will be the primary outcomes of the study, collected and evaluated using the predefined research progression criteria applied the green-amber-red method. Sociodemography and secondary outcomes, such as physical activity, dieting habits, daily occupations, occupational balance, health and quality of life will be assessed at baseline and 3 and 6-months follow-ups. The quantitative results will be comprehended through qualitative data from participant interviews which will nuance the feasibility evaluation. Analysis: Relevant statistical methods and qualitative analysis method will be applied. Expected results: The intervention will help families achieve sustainable lifestyle changes, e.g., diabetes stabilized blood glucose in adults with type 2 diabetes, increased physical activity time and improved dieting habits, for better family health and well-being. Ethics and dissemination: The trial does not have any obvious health risks for the participants. All the results - significant, non-significant and/ or inconclusive - will be reported.

NCT ID: NCT05694260 Recruiting - Clinical trials for Hypercholesterolemia

A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing

CLEAR Path 1
Start date: January 12, 2023
Phase: Phase 2
Study type: Interventional

Multiple-dose study to measure PK, PD and safety of bempedoic acid in pediatric patients 6 to 17 years of age with HeFH.

NCT ID: NCT05693909 Recruiting - Clinical trials for Beta Thalassemia Major Anemia

A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia

Start date: September 4, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about SP-420 ability to remove iron from organs in subjects with transfusion-dependent β-thalassemia. The main questions it aims to answer are: - How efficient is SP-420 in cleaning iron from the liver? - How is the safety and tolerability of ascending doses of SP-420? Participants will: - Take medication three time weekly - Attend up to 20 site visits - Undergo MRI scans

NCT ID: NCT05692856 Recruiting - Clinical trials for Skeletal Muscle Physiology

Muscle Memory After Treatment With Anabolic Substance Clenbuterol and Resistance Training in Humans

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The purpose of the project is investigate muscle memory and underlying mechanisms in humans following resistance training and use of the anabolic substance clenbuterol.

NCT ID: NCT05691192 Recruiting - Multiple Sclerosis Clinical Trials

Cognitive Reserve-building Activities in Multiple Sclerosis

CRAMS
Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

The study is a crossover randomized controlled trial investigating the effect of increasing engagement in cognitive leisure activities for individuals with multiple sclerosis.

NCT ID: NCT05687266 Recruiting - NSCLC Clinical Trials

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

AVANZAR
Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

NCT ID: NCT05686551 Recruiting - Huntington Disease Clinical Trials

GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease.

Start date: February 3, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease.

NCT ID: NCT05686538 Recruiting - AML/MDS Clinical Trials

Innate Donor Effector Allogeneic Lymphocyte Infusion After Stem Cell Transplantation: the IDEAL Trial

IDEAL
Start date: January 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The curative principle behind allogeneic hematopoietic stem cell transplantation (HSCT) is eradication of the malignant cells of the patient (recipient) by donor graft cells, a process termed graft-versus-leukemia (GVL) effect. GVL is traditionally mediated by donor αβ T cells in an immunological process driven by genetical differences between individuals, i.e. an allogeneic response. For this reason, αβ T cells also cause an unwanted and dangerous complication of HSCT called graft-versus-host disease (GVHD) in which healthy recipient cells are targeted by donor cells with great risk of morbidity and mortality to the patient. In addition to αβ T cells, other cells from the donor stem cell graft, termed innate effector lymphocytes, can contribute to the GVL effect. These are termed natural killer (NK) cells and T-cell receptor (TCR) γδ cells, the latter being a subset of T cells. NK and TCR γδ cells can recognize and eliminate leukemic cells in a direct tumor response independent of conventional allogeneicity. Therefore, opposite αβ T cells, innate effector lymphocytes cells can mediate GVL but are not likely to cause GVHD. The main indications for HSCT in adults are acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Approximately 50% of AML/MDS transplant patients experience significant acute GVHD and 30% experience relapse of the malignant disease. Prospective clinical studies from the research group of the investigators have shown that patients with high doses of innate lymphocytes in stem cell grafts and during early immune reconstitution after HSCT have a reduced risk of both GVHD and relapse. The aim of this clinical trial is therefore to administer innate donor lymphocyte infusion (iDLI) enriched in NK and TCR γδ cells and depleted of αβ T cells in patients early after HSCT. By improving the HSCT procedure with iDLI cell therapy the scope is less GVHD and less relapse of the malignant disease and thereby improved survival and life quality in AML/MDS patients.

NCT ID: NCT05686525 Recruiting - Clinical trials for Lower Urinary Tract Symptoms

Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men With BPH

TUMT-PAE-1
Start date: October 27, 2022
Phase: N/A
Study type: Interventional

The TUMT-PAE-1 trial is a randomised clinical trial aiming to compare the effectiveness of transurethral microwave thermotherapy (TUMT) with prostatic artery embolisation (PAE) in reducing urinary symptoms caused by prostate gland enlargement. The assessment will be done by patient reported and functional outcome measures. The primary purpose is to evaluate the urinary symptoms six months after the procedure, measured by the International Prostate Symptom Score (IPSS).