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NCT ID: NCT05431946 Enrolling by invitation - Quality of Life Clinical Trials

Palliative Care for Patients With Liver Cirrhosis

LiverCare
Start date: August 1, 2022
Phase:
Study type: Observational

Background: Patients with liver cirrhosis rarely receive palliative care although the Danish Health Authorities and WHO recommend it. The lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative care, which is perceived by many as exclusively for cancer patients and something that marks the end of active treatment. Study aim: Measure the effect of palliative care on the patient burden, caregiver burden, and the utilization of healthcare services. Study design: Prospective multi-center intervention study with end of study at the patients' death. We will use a 3-faceted endpoint 1) Patient burden measured by change in Hospital Anxiety and Depression Scale, 2) caregiver burden by a change in Zarit Caregiver Burden Questionnaire, and 1) health care system burden as the difference in number, length, and indication for hospital admissions and need for outpatient services. Patients: We will prospectively include 200 patients with liver cirrhosis (approx. 50 from each of 4-5 sites: Esbjerg, Herlev, Hvidovre, Århus) who have 2 or more items checked on the Supportive and Palliative Care Indicators Tool. Control groups will be identified from two non-participating hospitals and matched regarding age, gender, number of comorbidities, and alcohol and caregiver status. Methods: The intervention will be advanced care planning with conversations and actions built around a standardized symptom identification tool (EORTC QLQ-C15-PAL). Advance care planning is the collaborative process between patients and health care professionals of planning future health care. The assignment of a contact nurse to each participant is a key part of the intervention. Results: We will measure patient and caregiver burden at inclusion, after 4-6 weeks, 4-6 months, and every 6 months until the patient dies. All use of health care services will be registered. The use of health care services during the terminal 2 years will be compared that of control patients.

NCT ID: NCT05431257 Recruiting - Clinical trials for Acute Myeloid Leukemia

Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling

LD-VenEx
Start date: May 24, 2022
Phase: Phase 2
Study type: Interventional

Multi-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia. AZA and LD-VEN treatment is combined with exploratory AML profiling using established platforms for OMICs analyses and ex vivo drug sensitivity and resistance testing. This will validate the feasibility of AML profiling in a clinical setting to predict responders and non-responders to AZA/LD-VEN therapy. The exploratory AML profiling program will also identify biomarkers as well as novel drugs and drug combinations applicable for treatment of AML patients in future clinical trial initiatives.

NCT ID: NCT05428358 Not yet recruiting - Pancreatic Cancer Clinical Trials

Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery

MAGIPAC
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients.

NCT ID: NCT05426447 Recruiting - Diet, Healthy Clinical Trials

Protein and Performance (PROPER) in Endurance Athletes

PROPER
Start date: February 23, 2021
Phase: N/A
Study type: Interventional

The present study is a parallel group design with randomised allocation to either a 1) reduced protein diet (RP) or a 2) normal protein diet (NP). The two groups will be pair-matched based on habitual dietary protein intake, endurance training, endurance performance, and sex. The aim of the study is to investigate the effects of reducing dietary protein (~1g protein/kg body mass) compared to an eucaloric normal protein diet (~2g protein/kg body mass) for 6 weeks in well-trained endurance athletes on endurance performance, body composition, skeletal muscle protein synthesis, and health-related outcomes. The hypothesis is that endurance performance will maintain or even be improved in well-trained endurance athletes after a 6-week dietary intervention of an eucaloric, protein reduced diet compared to a normal protein rich diet.

NCT ID: NCT05425953 Recruiting - Clinical trials for Cardiovascular Diseases

Endocrine, Metabolic, Cardiovascular and Immunological Aspects of Sex Chromosome Abnormalities in Relation to Genotype

EMKISCA
Start date: June 13, 2022
Phase:
Study type: Observational

Observational study of 160 patients with sex-chromosome abnormalities and 160 matched controls. Blood, fat, muscle, skin, buccal swaps, urine will be collected and analized for DNA, RNA and methylation patterns. The goal is to associated genotype and epigenetic changes with the phenotype of patients with sex-chromosome abnormalities. Patients participate in questionnaries, dexa-scan of bones, fibroscans of liver, ultra sound of testicles and blood will be analysed for organ specific bloodsampels aswell as immunological and koagulation components.

NCT ID: NCT05425537 Active, not recruiting - Drowning Clinical Trials

Drowning in Denmark: A Six-year Registry-based Study of Fatal and Non-fatal Drowning

Start date: March 1, 2022
Phase:
Study type: Observational

Within a six-year period from 2016-2021, this retrospective cohort study aims to report: 1) the national incidence of non-fatal drowning accidents attended by the Danish Emergency Medical Services (EMS), 2) 48-hours and 30-day mortality, 3) Duration of hospitalization, 4) Neurological outcome at hospital discharge Furthermore, the investigators will follow the recommended guidelines for uniform reporting of data from drowning the "Utstein style" and investigate aspects associated with better outcome. Finally, the investigators wish to report spatial distribution of non-fatal drowning accidents. This can potentially result in recommendations towards certain educative, preventative, rescue, or treatment strategies to reduce OHCA from drowning.

NCT ID: NCT05423704 Active, not recruiting - Clinical trials for Head-and-neck Cancer

Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark

Start date: May 20, 2019
Phase: N/A
Study type: Interventional

A study to investigate feasibility of local selection of patients with squamous cell carcinoma of the pharynx or larynx using anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia.

NCT ID: NCT05422001 Recruiting - Opioid Use Clinical Trials

Low-dose KETamine as an Adjunct to MOrphine for Acute Pain in the ED

KetMo
Start date: May 31, 2022
Phase: Phase 4
Study type: Interventional

The KetMo study is an investigator-initiated, randomized, parallel group, double blinded trial investigating if ketamine as an adjunct to morphine improves pain treatment in the ED. Patients in pain (assessed on NRS, 5 or more) will be randomized to low-dose ketamine or placebo as an adjunct to morphine. Patients with or without prior use of opioids will be randomized separately. The primary outcome will be pain reduction, assessed on NRS, after 10 minutes. Secondary outcomes include pain reduction until 120 minutes after injection of study medicine, need for rescue opioid, side effects and patient- and provider satisfaction.

NCT ID: NCT05421286 Not yet recruiting - Inflammation Clinical Trials

The MISTRAL Study: Gut Microbiome Correlates of Serious AIDS and Non-AIDS Events

MISTRAL
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

MISTRAL (Microbiome-based stratification of individuals at risk of HIV-1 acquisition, chronic clinical complications, antimicrobial drug resistance, and unresponsiveness to therapeutic HIV-1 vaccination) is a 5-year EU Horizon 2020 project, running from 1/1/2020 - 31/12/2024. The project is led by Fundacio Privada Institut de Recerca de la Sida-Caixa CAIXA in Barcelona and aims to explore the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies. If successful, MISTRAL will benefit millions of human beings living with, or at risk of acquiring HIV-1 infection, and will produce novel concepts and technical innovations applicable to other human diseases. By doing that, MISTRAL will help to unlock the full clinical potential of the human microbiome to stratify patient outcomes and will irreversibly bring microbiome science closer to clinical practice

NCT ID: NCT05420233 Recruiting - Crohn Disease Clinical Trials

The CROCO Study: CROhn's Disease COhort Study

CROCO
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

The investigators propose to create a prospective Crohn Disease cohort, where patients receiving the most up-to-date therapies with a treat-to-target strategy, will be closely followed to characterize the progression of Crohn Disease by measuring the Lémann Index over time. The goal of the CROCO Study - "Crohn's Disease Cohort Study" is to promote a greater understanding of the long-term evolution of Crohn Disease , to describe prospectively the impact of different therapeutic strategies and develop accurate predictors of bowel disease damage and disability.