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NCT ID: NCT05628701 Recruiting - Ulcerative Colitis Clinical Trials

Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.

CRUISE
Start date: April 4, 2017
Phase: N/A
Study type: Interventional

Background There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. An attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves. Methods Adult Ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. Patients not declining reconstruction or not considered eligible for both methods will be followed as controls. The CRUISE study is a prospective, non-randomized, multi-center, controlled trial on satisfaction, QoL, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis. Discussion Reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, Quality of Life and patient satisfaction. The aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.

NCT ID: NCT05628285 Active, not recruiting - Clinical trials for Conductive Hearing Loss

Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear

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

A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and self-evaluation questionnaires.

NCT ID: NCT05625698 Completed - Breast Cancer Clinical Trials

Premarking of Axillary Nodes Before Start of Neoadjuvant Chemotherapy Using Magnetic Approach

SENTINEO
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy, radiotherapy and chemotherapy. During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit. Historically, all armpit lymph nodes were surgically removed but this approach is associated long term problems of arm swelling. In more recent times, an increasingly more selective approach is used to treat the armpit nodes. In the presence of cancer spreads in the nodes, an axillary clearance surgery is done otherwise, only the first node(s) also called sentinel node(s) that drain fluids from the cancer, is surgically removed. The identification of nodes using the latter approach is helped by injecting a tracer in the breast and via the lymphatic channels, the tracer is then concentrated in the sentinel nodes. Over recent years, neoadjuvant (preoperative) chemotherapy is being increasingly used to treat breast cancers. This treatment approach can lead up to a large of number of complete cancer response. This in turn can cause difficulties in locating the breast cancer / armpit nodes during surgery after the chemotherapy. New developments like superparamagnetic iron oxide nanoparticles (SPIO or MagTrace®) has been used as an alternate liquid tracer to mark sentinel nodes to facilitate armpit surgery. In addition, small magnetic clip called Magseed® has also been developed which can be inserted into the relevant lymph nodes thereby marking their anatomical position to facilitate surgery. Both MagTrace and Magseed can be used to pre-mark the cancer and armpit nodes before the start of neoadjuvant chemotherapy. In theory, premarking armpit nodes using a magnetic approach is associated with better surgical accuracy in the armpit but there is limited supporting data. Therefore, this study aims to investigate the feasibility of premarking armpit nodes, with or without cancer spread, using magtrace and magseed respectively before patients undergo neoadjuvant chemotherapy.

NCT ID: NCT05625399 Recruiting - Melanoma Clinical Trials

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

RELATIVITY-127
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

NCT ID: NCT05624450 Recruiting - Clinical trials for Viral Lung Infection and Acute Respiratory Failure

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

TILIA
Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

NCT ID: NCT05622201 Recruiting - Clinical trials for Schizophrenia Spectrum and Other Psychotic Disorders

A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults

RCT-RITS
Start date: March 21, 2023
Phase: Phase 2
Study type: Interventional

Immunological factors are assumed to be determinants for some psychiatric disorders, thus anti-inflammatory drugs may be helpful. However, studies on such treatments are scarce. An inflammatory modulating drug rituximab, cluster of differentiation antigen 20 antibodies (anti-CD20 antibodies), is a standard treatment for e.g. multiple sclerosis. The investigators aim to test rituximab in a randomised placebo-controlled double-blinded, add-on treatment trial in 120 participants (18-55 years) with schizophrenia spectrum disorder. Sampling from blood for analyses of inflammatory mediators are investigated at gene and protein levels and resting state functional magnetic resonance imaging (rsfMRI) and lumbar puncture are optional. Biomarkers will be investigated in relation to treatment response. Family member(s) to the patient and the patient (separate) will be asked to participate in a qualitative interview by an independent researcher after 3 months.

NCT ID: NCT05621343 Recruiting - Latent Tuberculosis Clinical Trials

New Strategies for Assessment of the Persistence of Viable Bacilli in Latent and Active Tuberculosis

TB-LIVE
Start date: December 21, 2021
Phase:
Study type: Observational [Patient Registry]

Current diagnostic tools such as interferon gamma release assay (IGRA) and purified protein derivative (PPD) can not distinguish patients with latent tuberculosis infection (LTBI) and persistence of live mycobacteria. This inability to rule out living mycobacteria in patients investigated for LTBI leads to unnecessary and potentially harmful treatment regimes all around the globe. The goal of this observational study is to identify candidate biomarkers for viable bacilli in latent tuberculosis in order to decrease the use of unnecessary and ineffective antibiotic treatment.

NCT ID: NCT05620875 Recruiting - Clinical trials for Aortic Valve Disease

The Association Between Delivered Oxygen and Cerebral Impact During the Use of Cardiopulmonary Bypass.

Start date: January 2, 2023
Phase:
Study type: Observational [Patient Registry]

Investigating the connection between delivered oxygen index and cerebral impact with COx (cerebral oximetry index) och cerebral injury markers during the routine use of cardiopulmonary bypass.

NCT ID: NCT05619783 Enrolling by invitation - Clinical trials for Amyotrophic Lateral Sclerosis

Extension Study Evaluating The Safety And Tolerability of AMX0035

Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the safety and tolerability of AMX0035 over 108 weeks of open label treatment for participants previously enrolled in Study A35-004 (PHOENIX).

NCT ID: NCT05619016 Recruiting - Breast Cancer Clinical Trials

[68Ga]Ga-ABY-025 PET for Quantification of HER2-status in Solid Tumors

Start date: November 23, 2022
Phase: Phase 2
Study type: Interventional

The goal of this phase II clinical trial is to improve the selection of patients with solid tumors who would benefit from effective treatment with HER2 targeted drugs. This will be achieved by examining patients with HER2 positive tumors in the esophagus or stomach or patients with advanced breast cancer with low HER2 expression (HER2low) with the HER2 specific positron emission tomography (PET) tracer ABY-025 (HER2-PET) and compare the imaging results with HER2 expression in tumor tissue derived from biopsies (reference standard).