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NCT ID: NCT06421597 Not yet recruiting - Clinical trials for Osteoporosis Secondary

Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease

RIGID
Start date: May 2024
Phase: Phase 2
Study type: Interventional

Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients' bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and a mixed meal test is performed.

NCT ID: NCT06416618 Not yet recruiting - Clinical trials for Proximal Humeral Fracture

Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years

PHF50-65
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture. The main questions it aims to answer are: • Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up? Aim is also to characterize the patient group aged 50-65 regarding fracture morphology, osteoporosis, and clinical frailty scale. The study compare operation with either plate or nail fixation to non-surgical treatment. Participants will: - Receive either surgical treatment or non-surgical treatment. - At 6 months, 1 year, and 2 years, the patient will answer two short questionnaires (Oxford Shoulder Score and Eq-5D-3L). The primary outcome will be Oxford Shoulder Score at 12 months. The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points. Adverse events and conversion to surgery will be registered. OSS and EQ-5D-3L will be completed just before the 6 months visit.

NCT ID: NCT06413706 Not yet recruiting - Glioma Clinical Trials

A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.

NCT ID: NCT06409260 Not yet recruiting - Clinical trials for Neuromuscular Blockade

Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to compare AMG and EMG (Philips IntelliVue NMT module and Senzime TetraGraph) in the objective monitoring of neuromuscular blocking in children between the age of 6 months and 2 years.The monitoring will be done bilaterally either on n.ulnaris or n. tibialis. The hypothesis of the study is that AMG will indicate faster recovery time (time to return to TOF 90%) from neuromuscular block than EMG.

NCT ID: NCT06407570 Not yet recruiting - Quality of Life Clinical Trials

Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment

Start date: June 1, 2024
Phase:
Study type: Observational [Patient Registry]

While the group of oral cavity cancer (OCC) survivors continue to increase, surgeons and oncologist intensify their search for improved treatment and rehabilitation methods to reduce the morbidity of management without compromising the oncological safety. The predominant problem after treatment of OCC is dysphagia, which is associated with malnutrition, aspiration pneumonia, hospital re-admission, and reduced quality of life (QoL) and survival. In a pilot study, the investigators found that 45% of OCC patients reported significant eating disabilities two years after surgical treatment. However, the international literature is limited on the dysphagia and QoL of OCC survivors. With an overall goal to improve the QoL and health status in patients treated for OCC, the present study aims to 1. systematically evaluate the swallowing function before and after treatment, 2. investigate the impact of swallowing function on QoL, 3. identify risk factors for dysphagia, 4. investigate if swallowing function is an independent factor for the number of ´days alive and out of hospital´ 5. evaluate the rehabilitation offered to OCC patients in Danish municipalities and the effect on swallowing outcomes. One hundred patients treated for OCC will be included prospectively during a 2-year period. Data on type and location of tumour, treatment modality, complications, patient weight, dietary intake, rehabilitation program, hospital admissions, recurrences, and survival will be collected. Questionnaires and Modified Barium Swallow Study (MBSS) will be performed before and 2 and 12 months after treatment.

NCT ID: NCT06406010 Not yet recruiting - Anesthesia, Local Clinical Trials

Investigating the Effect of Pericapsular Nerve Group (PENG) Block on Postoperative Pain After Peri-acetabular Osteotomy

Start date: June 1, 2024
Phase: Phase 4
Study type: Interventional

The aim of this study is to determine the effect of PENG blockade on postoperative pain after either ropivacaine 5 mg/mL or saline (placebo) in patients undergoing PAO. The hypothesis of this study is that PENG block with ropivacaine reduces postoperative pain compared to placebo (saline).

NCT ID: NCT06399978 Not yet recruiting - Clinical trials for Mild Cognitive Impairment

The Feasibility and Effect of Digital Cognitive Training in Mild Cognitive Impairment

Start date: May 6, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to assess the feasibility and effect of digital cognitive training based on the principles of Differential Outcome Training (DOT) in patients with Mild Cognitive Impairment. In DOT training, each stimulus-response pair to be learnt is followed by a unique reinforcer, as opposed to non-DOT (NDOT) training, where the stimulus-response pairs are all followed by a random reinforcer. DOT training is believed to boost learning more than NDOT training through associations. The main questions the study aims to answer are: - Whether at-home, tablet-based digital cognitive training is feasible in elderly patients with Mild Cognitive Impairment - Whether regularly digital cognitive DOT training has a positive effect on patients' cognitive functioning and quality of life - Whether any potential effects that the cognitive DOT training may have on the patients' cognitive functioning are transferable to the patients' daily life. Participation in the study includes: - A pre-training session at the site with the primary project coordinator, where the patient will complete a number of self-report questionnaires about their health, cognition, and quality of life as well as a neuropsychological assessment. - Training with the digital cognitive DOT training program at home for 20 min. per day 3-4 times a week for 6-8 weeks. - A post-training session at the site with the primary project coordinator after the 6-8 weeks have passed, where the patient will complete a usability questionnaire about the training programme, some of the same self-report questionnaires about their health, cognition, and quality of life as well as some of the neuropsychological assessments. - A 1-month follow-up session where the patients will complete some of the same self-report questionnaires again about their cognition and quality of life plus a questionnaire aimed the transferability of any positive cognitive effects of the training.

NCT ID: NCT06399354 Not yet recruiting - Heart Failure Clinical Trials

The Effect of Medium-chain Fatty Acids on Cardiac Function

MediHeart
Start date: May 20, 2024
Phase: N/A
Study type: Interventional

The effect of an acute intake of medium-chain fatty acids on heart function measured by cardiac magnetic resonance imaging (CMR) will be measured in individuals with heart failure with reduced ejection fraction (HFrEF) and in matched healthy controls with normal heart function. This aim will be investigated in a cross-over study including two visits: acute intake of medium-chain fatty acid or long-chain fatty acid as control. In addition, the effect of acute medium-chain fatty acid compared with long-chain fatty acid intake on whole-body lipid and glucose metabolism will be investigated.. The hypothesis is that acute consumption of medium-chain fatty acid will improve cardiac function in patients with heart failure.

NCT ID: NCT06398379 Not yet recruiting - Clinical trials for Clostridium Difficile Infections

Virus as Treatment of C. Difficile Infection (VISION)

VISION
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Fecal Virome Transplantation (FVT) has in small studies shown benefit in the treatment of recurrent C. difficile infection. In the VISION study we will treat patients with recurrent C. difficile infection with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Both will be following af standard treatment of antibiotics (Vancomycin)

NCT ID: NCT06396520 Not yet recruiting - Cerebral Palsy Clinical Trials

Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy

NIBS-CP
Start date: May 6, 2024
Phase:
Study type: Observational

Background: Early diagnosis of cerebral palsy (CP) is crucial, enabling intervention when neuroplasticity is at its highest. Magnetic resonance imaging (MRI) plays a vital role in CP diagnosis. Currently, diagnostic MRI of newborns and infants with suspected brain damage relies heavily on structural MR images. The current study aims to i) establish procedures for clinical infant and toddler MRI during natural sleep, ii) use advanced MRI sequences, such as advanced diffusion-weighted imaging (DWI), that may be more sensitive in detecting early brain damage, and iii) map relationships between early brain development, and motor function and development. Methods: The NIBS-CP study will enroll approximately 200 infants either at risk for CP or typically developing. Infants will be followed longitudinally (for three waves) between 3 months and 2 years of age with cerebral MRI at 3 Tesla and comprehensive assessments of motor and cognitive functioning. The MRI protocol includes advanced diffusion-weighted imaging, high-resolution structural MRI, and MR spectroscopy. The motor and cognitive assessments include Hand Assessment in Infants, Alberta Infant Motor Scales, Hammersmith Infant Neurological Examination, Peabody Developmental Motor Scales, Bayley Scales of Infant Development, and Ages and Stages Questionnaires. NIBS-CP aims to establish normative material on early brain development of Danish children and conduct normative modeling of typical and atypical development to identify deviations in brain development at the level of the single child. Discussion: Identifying predictive brain structural features of motor function and motor development is key to the future use of early MRI in the clinical work-up, as this promotes early diagnosis and (clinical) intervention strategies tailored to the individual child.