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NCT ID: NCT05025098 Recruiting - MDS Clinical Trials

Precision Therapy Versus Standard Therapy in AML and MDS in Elderly

PALM
Start date: June 22, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized clinical trial that randomizes between treatment principles. The study will investigate if precision therapy determined by a tumour board is better than standard treatment for acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) in elderly. The tumour board will decide the precision therapy based on identified genetic changes that can guide customized therapy. There are currently 40-50 targeted therapies approved for various cancers in Norway. The precision therapy will be given in addition to the standard treatment. The primary study objective will be to evaluate the cost-effectiveness of a precision therapy strategy compared with standard treatment. Other objectives will mesaure efficacy and satety of the treatment, and impact on life quality of the patients.

NCT ID: NCT05021198 Recruiting - Clinical trials for Cerebral Venous Sinus Thrombosis

The Norwegian Cerebral Venous Thrombosis Study

NoCVT
Start date: January 1, 2014
Phase:
Study type: Observational

The NoCVT study will investigate CVT (2014-2023) in a large Norwegian population (> 3 millions) using several approaches combining existing health registries, clinical databases and new prospectively collected clinical data to explore epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of CVT.

NCT ID: NCT05020236 Recruiting - Multiple Myeloma Clinical Trials

MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

MAGNETISMM-5
Start date: October 4, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

NCT ID: NCT05018286 Active, not recruiting - Clinical trials for Short Bowel Syndrome

Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

STARS extend
Start date: July 13, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

NCT ID: NCT05012332 Completed - Postoperative Pain Clinical Trials

Local Anesthesia Spread After an Erector Spinae Plane Block.

Start date: September 17, 2021
Phase: N/A
Study type: Interventional

This a single-center prospective spread-evaluation study where the primary objective is to assess the spread of local anesthesia in an ESPB using magnetic resonance imaging (MRI). The investigators will include 10 healthy volunteers from the hospitals internal website. All volunteers will receive a one-sided Erector Spinae Plane (ESP) block. 30 min after the block sensitivity to cold and pinprick will be assessed before an MRI is performed after 60 min postblock. An radiology specialist will evaluate the MR images pertaining to the spread of the local anesthesia.

NCT ID: NCT05011682 Completed - Obesity, Morbid Clinical Trials

The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery

Start date: August 27, 2021
Phase: N/A
Study type: Interventional

This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.

NCT ID: NCT05008133 Completed - Healthy Volunteers Clinical Trials

Mapping of Cardiac Power in Healthy Humans and Testing of a New Blood Pressure Sensor

Start date: May 14, 2021
Phase:
Study type: Observational

Brief Summary: The study will record hemodynamic data from 20 healthy volunteers at rest and during moderate bicycle exercise in the recumbent and half sitting position for the following purposes: Sub-study 1 Testing the overall accuracy and the dependence on changes in posture and exercise of a new non-invasive blood pressure sensor against simultaneous invasive measurements. Sub-study 2 Exploration of the effect of exercise and position on cardiac energy delivery to the circulation. The interplay between heart and vasculature (Ventriculo-arterial coupling) will be characterized based on simultaneous blood pressure and ultrasound blood flow measurements. Sub-study 3 Evaluation and possible improvement of an individualized mechanistic model predicting the hemodynamic response to exercise based on hemodynamic profile at rest. Sub-study 4 Testing of a machine learning based system for evaluation of dynamic autoregulation of renal blood flow from simultaneous continuous blood pressure and ultrasound blood flow measurements.

NCT ID: NCT05006976 Active, not recruiting - Depression Clinical Trials

A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study

NSAC
Start date: September 6, 2021
Phase: N/A
Study type: Interventional

The Norwegian Sickness Absence Clinic (NSAC) Nudge Study is a naturalistic randomized controlled multicentre trial which aim is to measure the efficacy of nudging clinicians' attention towards patients' motivation for work, barriers for return to work and work environment challenges, on functional recovery as primary outcome, and health outcomes as secondary outcome. Patients will be recruited in five different NSACs across northern Norway. In total 1100 patients will be randomized to two equal probability treatment arms: 1) NSAC with the nudge, and 2) NSAC without the nudge. The nudge is tailored to the individual patient's needs using survey, and the clinicians are presented with a summary of this patient survey prior to consultations highlighting health problems and challenges as reported by the patient in the survey.

NCT ID: NCT05006924 Recruiting - Clinical trials for Myotonic Dystrophy 1

Symptoms and Outcome Measures for Upper- Limb Function in Myotonic Dystrophy Type 1

SOUL-DM1
Start date: October 2021
Phase:
Study type: Observational

Myotonic Dystrophy type 1 (DM1) is a multisystem disease that causes muscle weakness and myotonia. As a result upper limb function might become impaired. In this study we will examine patients with DM1 and record their upper limb function. We will will use a battery of patient reported outcomes (PROs) and Outcome measures (OMs) in order to evalute which ones are suitable for use in clinical practise and research studies.

NCT ID: NCT05005975 Active, not recruiting - XLP Clinical Trials

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

Start date: August 10, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the long-term safety and tolerability of oral dersimelagon.