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NCT ID: NCT05992038 Recruiting - Clinical trials for Osteo Arthritis Knee

Use of a Putty as Gap Filler in Open-wedge Osteotomy

AXOS
Start date: September 20, 2023
Phase: N/A
Study type: Interventional

Rationale: Realignment osteotomies around the knee are a proven surgical treatment for unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in the early postoperative phase. This is probably due to a combination of bony cut (bone pain) and postoperative hematoma (bleeding and leakage of the bone marrow) in the surrounding soft tissue. The AttraX® Putty can be used as a gap filler in open wedge osteotomies to potentially reduce postoperative pain by reducing the bleeding from the bone gap. Objective: The main aim of this study is to determine whether early postoperative pain is decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open wedge osteotomy without filling the gap. The secondary aims are faster accelerated rehabilitation/regaining function, reduction of local blood loss, accelerated bone union, comparable surgical accuracy, and the occurrence of (serious) adverse events. Study design: Single-blinded, prospective, randomized controlled trial. Study population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double level osteotomy. Intervention: According to a randomization scheme, the osteotomy gap will be filled with either the synthetic ceramic material AttraX® Putty or without a gap filler (conventional method). Main study parameters/endpoints: The main study endpoint is the Numeric Rating Scale (NRS) pain during the first week postoperative. The secondary study endpoints are faster rehabilitation/regaining function, reduction of local blood loss, accelerated bone union, comparable surgical accuracy, and (serious) adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients may have the advantage of experiencing less pain postoperatively if they are treated with the AttraX® Putty, which can contribute to a faster rehabilitation. Risks to the AttraX® Putty group may include an allergic reaction, failure to promote bone fusion and excessive bone growth. However, the preclinical studies and clinical studies show that the use of AttraX® Putty is safe for use in humans.

NCT ID: NCT05990725 Recruiting - Atopic Dermatitis Clinical Trials

Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

ADhope
Start date: November 20, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the effectiveness of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT05989022 Recruiting - Clinical trials for Breast Cancer Diagnosis

Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics

Start date: November 24, 2023
Phase: N/A
Study type: Interventional

Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems

NCT ID: NCT05988060 Recruiting - Clinical trials for Head and Neck Cancer

Physical Exercise for Patients With Head and Neck Cancer

VITAL
Start date: November 9, 2022
Phase: N/A
Study type: Interventional

The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT). Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).

NCT ID: NCT05987631 Recruiting - Clinical trials for Bariatric Surgery Candidate

Predictors of Weight Loss and Metabolic Health After Bariatric Surgery

Start date: January 19, 2023
Phase:
Study type: Observational

In this prospective study the investigators aim to identify preoperative predictors of improvement of metabolic health and weight loss after bariatric surgery focusing on inflammation, insulin sensitivity (in a subgroup of patients), glucoregulatory determinants, psychological traits, feeding behavior characteristics and cardiorespiratory fitness

NCT ID: NCT05987332 Recruiting - Clinical trials for Metastatic Uveal Melanoma

IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

Start date: October 31, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

NCT ID: NCT05986968 Recruiting - Clinical trials for ST Elevation Myocardial Infarction

The Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage

STOP-IMH
Start date: July 6, 2023
Phase: N/A
Study type: Interventional

The main goal of this clinical trial is to assess the safety of direct omission of aspirin after Percutaneous Coronary Intervention (PCI) in patients with ST elevation myocardial infarction (STEMI). The secondary objectives are to demonstrate the reduction of intramyocardial haemorrhage and infarct size, which will be measured after 1 week; to compare clinical bleeding outcomes and to compare platelet reactivity and inflammatory response in STEMI patients receiving ticagrelor monotherapy versus dual antiplatelet therapy. Patients will be treated with either ticagrelor monotherapy or dual antiplatelet therapy (aspirin plus ticagrelor) after PCI. They will be compared to see if the omission of aspirin is safe in terms of major adverse cardiac and cerebral events at 13 months follow-up.

NCT ID: NCT05986032 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia

REACT
Start date: July 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the correlation between respiratory system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation. The main question it aims to answer is if the reactance z-score at 7 postnatal days adds to relevant clinical factors in the prediction of bronchopulmonary dysplasia. Participants will receive respiratory oscillometry measurements at 7 ± 2 postnatal days.

NCT ID: NCT05984810 Recruiting - Clinical trials for Pancreas Adenocarcinoma

NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101

FLUOPANC-II
Start date: March 18, 2024
Phase: Phase 2
Study type: Interventional

Pancreatic carcinoma has a dismal prognosis at time of diagnosis, due to late onset of clinical symptoms, patients present with advance disease. Complete surgical resection is the only potential curative treatment, however only a small percentage is eligible for upfront total surgical resection due to extension into anatomical related important vascular structures. Neoadjuvant chemo(radio)therapy has become the standard treatment modality for non-primary resectable disease (borderline resectable and locally advanced pancreatic cancer (LAPC)), where subsequent downstaging can make identification of the primary tumor more challenging during surgery. Near-infrared (NIR) fluorescence imaging can aid surgeons by providing real-time visualization of tumors, suspect lymph nodes and vital structures during surgery. Additional intra-operative feedback could possibly reduce the frequency of positive resection margins and increase complete removal of locally spread tumor and involved lymph nodes and could thereby improve patient outcomes as well as overall survival. SGM-101 is a targeted NIR-fluorophore, with specific binding capacity for Carcino Embryonic Antigen (CEA) which is overexpressed on tumor cells in the gastro-intestinal tract, including pancreatic cancer.

NCT ID: NCT05984277 Recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

eVOLVE-Lung02
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.