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NCT ID: NCT05839418 Recruiting - Status Epilepticus Clinical Trials

Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

SENSEII/AROUSE
Start date: March 1, 2023
Phase:
Study type: Observational [Patient Registry]

SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.

NCT ID: NCT05839080 Recruiting - Physical Inactivity Clinical Trials

FoodACT: Investigating the Impact of a School Garden Intervention on Children's Food Literacy, Climate Literacy, School Motivation and Physical Activity

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

The purpose of this study is to investigate the efficacy of a schoolgarden intervention on pupils food literacy, climate literacy, schoolmotivation and physical activity. The study will also investigate the contextual characteristics in the garden using systematic observations and the pupil´s experience of the intervention with focus-groups interviews.

NCT ID: NCT05838079 Recruiting - Clinical trials for Congenital Heart Disease

Copenhagen Baby Heart Study - Impact

CBHS-I
Start date: November 1, 2018
Phase:
Study type: Observational

Copenhagen Baby Heart Study - Impact (CBHS-I) is an extension to Copenhagen Baby Heart (CBH) which included over 25.000 new-borns in the Copenhagen area between 2016-2018. Based on clinical and subclinical deviations in the examinations in CBH, subgroups of participants will be invited to clinical examinations (echocardiography and electrocardiogram) in early childhood. There will also be a new, targeted inclusion based on certain exposures during pregnancy. The main objectives are to assess the prevalence of congenital and inherited heart disease and, and the development of these during early childhood; examining the association between pre- and postnatal exposure, disease, lifestyle, environmental and genetic factors; continue to establish reference values for echocardiography in Danish neonates and children.

NCT ID: NCT05836324 Recruiting - Solid Tumors Clinical Trials

A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Start date: July 24, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

NCT ID: NCT05835674 Recruiting - Cerebral Palsy Clinical Trials

CP-EDIT: Cerebral Palsy - Early Diagnosis and Intervention Trial

CP-EDIT
Start date: April 1, 2023
Phase:
Study type: Observational

Background. Early diagnosis of cerebral palsy is important as intervention becomes possible at a time where neuroplasticity is at the highest. Current mean age at diagnosis is 13 months in Denmark. Recent research has documented that implementation of an early-diagnosis set-up can lower diagnostic age of cerebral palsy. The aim of the current study is to show that the response to the early intervention program added to standard care is superior to standard care alone in a Danish multi-site setting in children from both a newborn and infant detectable risk pathway. Methods The current study CP-EDIT (Early Diagnosis and Intervention Trial) with the GO-PLAY intervention included (Goal Oriented ParentaL supported home ActivitY program), aims at testing feasibility of an early diagnosis and intervention set-up in four paediatric centers. In a prospective cohort study design, we will consecutively include a total of 500 infants. We will systematically collect data at inclusion and follow a subset of participants with definite cerebral palsy or high risk of cerebral palsy until they are two years of age. The focus is on eight areas related to implementation and the perspective of the families: Early MRI; early genetic testing; implementation of the General Movements Assessment method; early prediction of cerebral palsy; comparative analysis of the Hand Assessment for Infants method and evaluation by Hammersmith Infant Neurological Examination, MRI, and the General Movements method; analysis of the GO-PLAY early intervention; parental perspective of early intervention; and parental perspective of having an early diagnosis. Discussion Early screening for CP is increasingly possible and an interim diagnosis of "high risk of CP" is recommended but not currently used in our clinical care. There is a need to accelerate identification in mild or ambiguous cases to facilitate appropriate therapy early. The majority of studies on early diagnosis focus on identifying CP in infants below five months corrected age. Little is known about early diagnosis in the 50% of all CP cases that are discernible later in infancy, which is also addressed in this study. The study aims at improving care of patients with cerebral palsy even before they have the diagnosis established.

NCT ID: NCT05834803 Recruiting - Heart Failure Clinical Trials

Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.

DAN-PTRAII
Start date: June 26, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to document a beneficial effect of percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic renal artery stenosis in high-risk patients selected according to the criteria used in the DAN-PTRA study. The main questions the trial aims to answer are if renal artery stenting compared with optimal medical treatment alone has beneficial effects on: - Blood pressure - Kidney function - Hospitalizations for heart failure

NCT ID: NCT05834452 Recruiting - Clinical trials for Benign Paroxysmal Positional Vertigo

Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair.

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

Comparison of treatment efficacy of Epley maneuver and 360 maneuver in a mechanical rotational chair (TRV chair) in patient with posterior benign paroxysmal positional vertigo (BPPV).

NCT ID: NCT05834010 Recruiting - Anorexia Nervosa Clinical Trials

Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa

ReBoot
Start date: March 18, 2023
Phase: Early Phase 1
Study type: Interventional

The investigators hypothesize that prolonged undernutrition in anorexia nervosa alters the microbiome to a different steady-state (dysbiotic) composition that sustains the disease, even after returning to normal diet. The investigators propose that transplanting a fully ecologically functioning GM from a healthy donor, through a FMT, can reboot the gut-brain-axis, ameliorate symptoms and improve clinical outcomes. To approach this, in the challenging AN patient group, the investigators want to conduct a FMT feasibility/pilot study.

NCT ID: NCT05833087 Recruiting - Clinical trials for Treatment Resistant Depression

Schema Therapy for Patients With Chronic Treatment Resistant Depression

DEPRE-ST
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical study is to test a particular form of psychotherapy, called schema therapy, for people with difficult-to-treat depression (when depression is very lengthy or difficult to cure with antidepressive medication). Researchers will compare the group of participants receiving schema therapy to a group receiving standard psychotherapeutic treatment to see if schema therapy is more effective on depression symptoms and other important issues for the participant. The main question the study aims to answer is: - Can schema therapy be a more effective treatment for difficult-to-treat depression than other forms of psychotherapy offered in psychiatry today? People who have difficult-to-treat depression are a special group of patients who are more strained in a wide range of areas of life than other people with depression. They also more often have childhood trauma, as well as simultaneous personality disorder or personality traits that brings challenges in everyday life. Currently we can not offer a sufficiently effective psychiatric treatment for this group of people. Schema therapy was developed to help patients who do not have sufficient effect of the usual psychotherapeutic treatments. It also addresses personality disorders or problematic traits and childhood trauma directly in the therapy. The project will include 129 participants in total, of which half will receive schema therapy. Treatment is provided at four psychiatric centers at both the Southern and the Capital Region of Denmark. Participants receiving schema therapy will be given 30 sessions of weekly therapy, as well as the opportunity for the rest of the standard care package in the Danish secondary mental health system, that is, treatment with psychopharmacological medicine and meetings with next-to-kin and other parts of the participant's support system. Participants receiving the standard treatment will receive 6-16 sessions of individual or group therapy with a range of other psychotherapies that are not schema therapy, as well as the other parts of the standard care package as listed above. If schema therapy proves to be more effective for treatment of difficult-to-treat depression than the treatment offered today, it may give rise to more extended use of schema therapy in and outside psychiatry. This means that the toolbox for the treatment of difficult-to-treat depression is expanded with a new specialized and effective psychotherapeutic tool.

NCT ID: NCT05830994 Recruiting - Clinical trials for Gastroparesis With Diabetes Mellitus

Trial Investigating Efficacy of G-POEM

G-POEM
Start date: April 12, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized sham-controlled trial is to ivestigate efficacy and safety of G-POEM in treatment of diabetic gastroparesis and explore impact of G-POEM on glucose metabolism and incretine hormones.