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NCT ID: NCT04903899 Recruiting - Neuroblastoma Clinical Trials

177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma

LuDO-N
Start date: May 19, 2021
Phase: Phase 2
Study type: Interventional

The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to achieve a maximal effect on the often rapidly progressing disease. This strategy requires a readiness for autologous stem cell transplantation in all patients, but is not anticipated to increase the risk of long-term sequelae, since the cumulative radiation dose remains unchanged. The primary aim of the study is to assess the response to 177Lu-DOTATATE treatment at 1 and 4 months after ende of treatment. Secondary aims are to assess survival and treatment-related toxicity. Additional aim are to correlate tumour dosimetry with response, correlate SSTR-2 expression with 68Ga-DOTATATE uptake and to correlate the uptake with the treatment response.

NCT ID: NCT04902768 Completed - Clinical trials for Congenital Heart Disease

Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

APPROACH-IS II
Start date: August 1, 2019
Phase:
Study type: Observational

This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

NCT ID: NCT04900506 Recruiting - Clinical trials for Femoral Neck Fractures

Surgical Approach in Hemiarthroplasty. A Randomized Clinical Trial Comparing Posterior and Anterior Approach

Start date: January 21, 2022
Phase: N/A
Study type: Interventional

Dislocated femoral neck fractures are routinely treated with cemented hemiartroplasty and the direct lateral approach (Hardinge) has commonly been used in Norway. The investigators have lately witnessed a significant change in the prefered surgical approaches in total hip arthroplasty (THA) in favor of the posterior and anterior approaches. The direct lateral approach has in THA, more or less, been abandoned in Norway. Numerous studies have reported superior results using the posterior and anterior approahes compared to the lateral approach.

NCT ID: NCT04898504 Recruiting - Colorectal Cancer Clinical Trials

HAI-Floxuridine, or Liver-Tx, Combined With 2nd Line Chemotherapy Versus 2nd Line Chemotherapy Alone for Patients With Colorectal Liver Metastases and Heavy Tumour Burden.

EXCALIBUR1+2
Start date: August 23, 2021
Phase: Phase 2
Study type: Interventional

Patients with colorectal livermetasteses and heavy tumour burden and progression on 1st line chemotherapy have no other available treatment in Norway today other than 2nd line chemotherapy. The Investigators will randomize patients to HAI-floxuridine (FUDR), or liver-Tx, in addition to 2nd line chemotherapy versus 2nd line chemotherapy alone (Excalibur 1) or systemic chemotherapy with HAI/FUDR versus systemic chemotherapy alone (Excalibur 2). Primary endpoint is overall survival at 2yrs.

NCT ID: NCT04898452 Recruiting - Infection Clinical Trials

Intravenous Antibiotic Treatment at Home

Hosp@Home
Start date: July 2, 2020
Phase:
Study type: Observational

The purpose of the study is to develop and evaluate a new model for across services interaction with the use of welfare technology and telemedicine. The model includes innovative and new routines for the exchange of patient information, quality systems and procedures between the municipality and the hospital. This model will first be tested for use in intravenous antibiotic therapy. The results of the study will be used to further develop the service. In the larger context, it is desirable to provide knowledge that is transferable to other diagnostic groups, treatment methods and geographical areas.

NCT ID: NCT04898335 Recruiting - Clinical trials for Mitral Regurgitation

Tendyne European Experience Registry

TENDER
Start date: April 15, 2021
Phase:
Study type: Observational [Patient Registry]

TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

NCT ID: NCT04893551 Terminated - Ovarian Neoplasms Clinical Trials

A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants

Start date: February 25, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose is to assess the safety and tolerability of tilvestamab following IV administration of multiple doses to participants with HGSOC who have been treated with at least 1 complete course of platinum-based chemotherapy and whose disease has relapsed with platinum resistance ([PRR]-HGSOC) and to determine the plasma pharmacokinetics (PK) exposure by comprehensive profiling (at single dose and steady-state) of multiple ascending doses of tilvestamab.

NCT ID: NCT04893473 Withdrawn - Ischemia Clinical Trials

New Method for Real-time Detection of Tissue Ischemia

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

This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlertâ„¢ device in patients scheduled for limb (arm/leg) surgery with tourniquet. IscAlert is measuring carbon dioxide in muscular and subcutaneous tissue. IscAlert is inserted into normal muscle and subcutaneous tissue in ischemic (operated limb with a tourniquet) and non-ischemic limb (non-operated limb).After the tourniquet is inflated, ischemia develops in the muscles and subcutaneous tissue. This will result in an increase in carbon dioxide, which will be detected by the sensor on the operated extremity, while the sensor on the non-operated will show normal values. After releasing the tourniquet cuff, the muscle will be reperfused and the carbon dioxide level is expected to decrease into normal levels. 50 number of patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the operating room, but in 25 of the patients, IscAlertâ„¢ will be inserted for 72 hours in the operated extremity after the end of surgery. After this, the sensors are removed.250 Devices is planned to be used in this clinical study.

NCT ID: NCT04891380 Completed - Clinical trials for Cardiac Arrest, Out-Of-Hospital

BCG Biosensor and Non- and Invasive Monitoring During Emergency Medicine Cases, a Prospective Feasibility Study

Start date: May 18, 2021
Phase: N/A
Study type: Interventional

In a out of hospital emergency medicine study the investigators will measure hemodynamic effects of implemented treatments for patients with cardiac arrest, hypotension, and intensive care transports. The investigators will use both non-invasive and invasive measuring technology to measure this. Ballistocardiographic biosensors are introduced together with more advanced non-invasive and invasive measurements such as invasive arterial blood pressure with cardiac output calculation and saturation cerebral tissue oxygenation (SctO2). During treatment of cardiac arrest patients the investigators will use a new LUCAS 2 Active Decompression device (LUCAS 2 AD2) and measure different hemodynamic variables.

NCT ID: NCT04891133 Terminated - COVID-19 Clinical Trials

EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial

Bari-SolidAct
Start date: June 3, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

EU SolidAct is a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to hospital with COVID-19. The platform is designed for running phase 2 and phase 3 trials, and with modular data capture (end point/safety data, biobanking, add-on studies) depending on the capacity of participating sites. The study consists of two parts with different primary end points depending on disease stage: EU SolidAct part A includes hospitalized patients with moderate disease, whereas EU SolidAct part B includes hospitalized patients with severe and critical disease.