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NCT ID: NCT05584410 Recruiting - Clinical trials for Osteoarthritis, Knee

Digitalization of Osteoarthritis Care

Start date: December 5, 2022
Phase: N/A
Study type: Interventional

The overall aim of this study is to compare three different care models for patients with hip- and knee osteoarthritis. The primary aim is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis

NCT ID: NCT05584280 Recruiting - Myocardial Ischemia Clinical Trials

Systematic Post-Implementation Evaluation of Stents

SPECS
Start date: December 7, 2022
Phase:
Study type: Observational

To conduct a quality assurance project to establish the differences in health care processes and cost effectiveness of having the thin-strut Orsiro stent versus the thicker strut Promus stent on the shelf (i.e. as the most accessible stent).

NCT ID: NCT05583227 Recruiting - Clinical trials for Eosinophilic Esophagitis

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

CROSSING
Start date: November 10, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).

NCT ID: NCT05583097 Recruiting - Thyroid Cancer Clinical Trials

The Ultracyt Study - is EU-TIRADS Useful in Selecting Nodules for Fine Needle Aspiration Cytology?

Ultracyt
Start date: February 15, 2022
Phase: N/A
Study type: Interventional

This is a randomized study evaluating selective fine-needle aspiration cytology based on structured ultrasound using EU-TIRADS versus non-selective ultrasound guided cytology. Primary outcome is frequency of suspicious cytology (Bethesda III-VI) which is expected to be higher in the selective group compared to the non-selective group. Secondary outcome is the frequency of malignancy which is expected to be equal in both groups. However, the investigators do not expect to reach statistical significance for the secondary outcome according to power calculations.

NCT ID: NCT05581199 Recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

Start date: December 15, 2022
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin [Ig] or plasma exchange [PLEX]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.

NCT ID: NCT05580549 Recruiting - Hypertension Clinical Trials

Prevalence of Hazardous Alcohol Use in a Population With Hypertension in Primary Care

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

The goal of this observational cross-sectional study is to map the prevalence of hazardous alcohol use in 270 adult patients with hypertension in Primary Health Care (PHC). The main question it aims to answer is: What is the prevalence of hazardous alcohol use in a population with hypertension in primary care detected with PEth and AUDIT, analysed in relation to patients with controlled, uncontrolled and treatment resistant hypertension? Participants will, in conjunction with annual control of hypertension with a General Practitioner (GP) at their Primary Health Care Centre (PHCC), visit a study nurse. The study nurse will collect following data: • Physical measurements• Lifestyle habits• Quality of life and demographic data • Drugs for hypertension and comorbidity • Laboratory tests including Phosphatidylethanol (PEth).

NCT ID: NCT05578976 Recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

EPCORE DLBCL-2
Start date: February 8, 2023
Phase: Phase 3
Study type: Interventional

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

NCT ID: NCT05578716 Recruiting - Infant Formula Clinical Trials

Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula

GRANDIOSA
Start date: October 3, 2022
Phase: N/A
Study type: Interventional

Breastfeeding is the recommended diet for all infants during the first half of infancy and is associated with numerous health benefits. However, when breastfeeding is not possible, an infant formula is the only nutritive alternative. Formula-fed infants have a different growth pattern compared to breastfed infants. Studies have shown that the higher protein content in infant formula compared to breastmilk results in a more rapid weight gain and an increased risk of overweight and obesity in childhood. For this reason, both quantity and quality of protein in infant formulae have been optimized during the last decade, to better meet the needs of infants and to support growth close to that of breastfed infants. Protein hydrolysis, a common modification of infant formulae, has originally been developed for treatment of cow's milk protein allergy. Certain hydrolysed formulae have been suggested to prevent atopic eczema when given to infants with a family history of allergic disease but as of yet, the allergy preventive effect in infants without increased risk of allergic disease has been little studied. Partially hydrolysed infant formulae have also been suggested to reduce common functional gastrointestinal symptoms in infants. New protein hydrolysates are continually developed for use in infant formulae, with the aim of reducing allergenicity, while ensuring optimal growth and development of infants. It is important to study the effects on growth and health outcomes in infants who are fed formulae based on these newly developed hydrolysates as compared to those fed standard intact protein formulae or breastmilk. The overall aims of the current study are to evaluate the effects of two new hydrolysates on growth, immunological biomarkers, neurodevelopment, protein metabolism and gut microbiota in a randomized, controlled clinical trial of healthy infants. In compliance with European Food Safety Authority (EFSA) regulations for novel infant formulas based on hydrolysed protein, the primary outcome is change in weight standard deviation score (SDS) from baseline until 5 months of age.

NCT ID: NCT05576285 Recruiting - Clinical trials for Retinal Hemorrhage, Left Eye

Retinal Imaging Study of Children That Might be at Risk of Having Retinal Hemorrhages

RISC
Start date: February 8, 2023
Phase:
Study type: Observational

This is a clinical trial in which we will learn about the retinal findings in three clinical groups of children, who might be at risk of having retinal hemorrhages (RH). The aim of the study is to explore the occurrence of moderate to severe retinal hemorrhages in critically ill children, children with intracranial hemorrhages, hydrocephalus or signs of elevated intracranial pressure and in children with benign enlargement of subarachnoid spaces (BESS). 1. Are RHs associated with BESS? 2. What is the prevalence, distribution and extent of RHs in critically ill children? 3. What is the prevalence, distribution and extent of RHs in children with traumatic brain injury? 4. Does the prevalence, distribution and extent of RHs differ in children with witnessed traumatic brain injury from children with traumatic brain injury of unknown origin? 5. To what extent do the causes of RHs affect visual acuity, initially and during recovery? A retinal ophthalmoscopy through dilated pupils will be conducted and a fundus photograph will be taken by a handheld, non-touch camera.

NCT ID: NCT05575960 Recruiting - Major Depression Clinical Trials

Interpersonal Psychotherapy for Adolescents and Young Adults

Start date: October 3, 2022
Phase: N/A
Study type: Interventional

The purpose of the project is to study the effectiveness of Interpersonal Psychotherapy (IPT) for adolescents with depression. Specific aims are to analyze the effects, change mechanisms, predictors, and implementation of IPT for youth. In this four-year project we will include 60 patients with depression. Outcome will be studied using a quasi-experimental multiple-baseline design. Change mechanisms will be studied in the form of mentalizing, emotion regulation, social support, and working alliance session-by-session, and with post-treatment qualitative interviews about the participants' experiences of change. Predictors of effectiveness of IPT for adolescents will be explored by measuring severity of symptoms, anxiety symptoms, presence and severity of parent-child conflicts, quality of interpersonal relationships, experiences of bullying, and school functioning. The implementation process of IPT for youth will be studied through interviews with adolescents, parents, therapists, co-workers, and local managers. The study is conducted within child and adolescent psychiatric services in Norrköping using a practice-oriented research strategy which emphasizes close collaboration with clinicians. The project is a collaboration between researchers at Linnaeus University and Linköping University, and clinicians at BUP Norrköping.