There are about 11304 clinical studies being (or have been) conducted in Denmark. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib versus asciminib 80mg in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)
Type 2 diabetes (DM2) I may be associated with low level of Quality of Life (QOL), depression, persistent stress and autonomic nervous system dysfunction (ANSD). A new biological measure measuring the Pressure Pain Sensitivity (PPS) of the chest bone has been found to be a marker for persistent stress and ANS function, and linked to depression, QOL, chronic inflammation and HbA1c. An intervention which uses the PPS measure as a biological feedback marker for stress reduces the level of persistent stress (PPS) and depression, reduces blood pressure, serum lipids, restores ANSD and increases quality of life. Objectives: primary: if a simple individualized self-care based intervention, using the PPS of the chest bone as a biofeedback marker for stress, reduces PPS and with concomitant reduction in HbA1c. Secondly, if changes in PPS and HbA1c correlate, if the level of depression and number of clinical stress symptoms are reduced, and QOL and personal empowerment increased. Thirdly, if use of glucose-lowering medication, blood pressure, heart rate, work of the heart, autonomic nervous system dysfunction measured by PPS and cardiovascular response to tilt table test and heart rate variability, serum lipids and low-grade inflammation are reduced. As a separate part of the study, the implementation aspects of the PPS guided intervention are studied. Design:RCT,single-blinded, 1:1 randomization, in which diabetic treatment as usual (TAU) is compared to TAU plus a self-care based intervention program based on daily PPS measurements at home over a 6 months period and daily 2 times nervestimulation as mandatory. The study will be open to the patient and the treating professionals but blinded towards the evaluating researchers. The implementation part of the study will be conducted according to WHO guidelines. Patients: 160 patients with DM2 from primary health care. Effect variables: Primary: HbA1c. Secondary : PPS, depression, QOL, personal empowerment, and the correlation between changes in PPS and HbA1c. Treatment: All patients receive diabetes care as usual. The active group receives in addition the self-care based, non-pharmacological PPS guided intervention program, which focuses on daily PPS measurement for cognitive reflection and cutaneous sensory nerve stimulation for reduction of PPS with the aim to reduce the elevated PPS.
This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a liver-specific promoter. The pharmaceutical form of AMT-061 is a solution for intravenous infusion administered at a dose of 2 x 10^13 gc/kg.
The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
The purpose of this study: In a prospective randomized study with 2 years of follow-up we want to compare the migration of the uncemented trabecular metal (TM) versus the cemented tibial and femoral components of the new Persona® total knee arthroplasty (TKA) assessed by model based radiostereometric analysis (MB-RSA). Also, we want to compare the adaptive bone remodeling induced by the uncemented TM versus the cemented tibial and femoral components of the new Persona® TKA assessed by dual energy-X-ray (DEXA). Data generated for both above mentioned, will be also compared with historical RSA and DEXA data for the NexGen TKA using TM tibia modular and monoblock.
2X-121 is a small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The PARP inhibitor demonstrated clinical activity in a prior Phase 1 study in a number of solid tumors. 2X-121 has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2. The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome some of the PARP inhibitor resistance. The Phase 2 study is using 2x-121 DRP® biomarker in metastatic breast cancer patients to identify patients likely to respond to and benefit from treatment with 2X-121.
The aim of the project is to evaluate the use of the caregiver-led 'CSNAT intervention' to identify, prioritize and address support needs among caregivers of cancer patients who are starting in basic palliative care at home in Denmark
This study investigates repetitive cold-water exposure on brown fat activity assessed by PET/CT scanning. Furthermore we will assess glucose control upon winter-swimming. Obese prediabetic men and women will be randomized to winter-swimming or control conditions for 4 months.
Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is needed. Immunotherapy represents the largest advance in cancer therapy in recent years and has demonstrated promising activity in SCLC. In this study we will investigate whether atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy.
A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.