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NCT ID: NCT05067660 Not yet recruiting - Clinical trials for Prostate Cancer Recurrence After Radical Prostatectomy

Targeted Radiotherapy for Recurrent Prostate Cancer

TASTEPRO
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The TASTEPRO pilot trial evaluates the feasibility of PSMA PET-CT (Computer tomography) targeted stereotactic radiation therapy (SABR) in management of lymph node positive prostate cancer recurrence after radical prostatectomy. Targeted SABR is compared to current standard; template-based salvage radiation therapy. The investigators expect SABR to be of equal or better oncological outcome compared to the standard therapy with less radiation-induced side-effects. Results of the pilot trial will be used when designing larger trials on oncological efficacy and safety of PSMA PET-CT targeted SABR.

NCT ID: NCT04774939 Not yet recruiting - Venous Reflux Clinical Trials

EVLA and Optimal Timing of Sclerotherapy

FinnTrunk
Start date: March 15, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.

NCT ID: NCT04727957 Not yet recruiting - Clinical trials for Ventilator-Associated Event

Predictive Analytics in Lower Respiratory Tract Infections (VA-LRTIs)

PA in VA-LRTIs
Start date: June 1, 2021
Phase:
Study type: Observational

To determine the accuracy and generalizability of VA-LRTI algorithm to detect and predict three high-incidence and high-impact VAEs from electronic health records data: 1) ventilator-associated event, 2) ventilator-associated pneumonia, and 3) ventilator-associated tracheobronchitis.

NCT ID: NCT04724811 Not yet recruiting - Acetabular Fracture Clinical Trials

Weight-bearing of Surgically Treated Acetabular Fractures.

Start date: May 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively. Both study groups are stratified according to - Type of fracture (anterior approach vs anterior + additional posterior approach) - Dislocated dome vs non-dislocated/ non existing separate dome fragment Patients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. This is to examine a potential participation bias in the RCT groups. These patients will not be counted into the target amount of 50 RCT patients.

NCT ID: NCT04705389 Not yet recruiting - Clinical trials for Merkel Cell Carcinoma

SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines

SUMMERTIME
Start date: September 2021
Phase: N/A
Study type: Interventional

Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion from baseline diagnosis, in a cohort of 150 European MCC patients

NCT ID: NCT04696523 Not yet recruiting - Cerebral Infarction Clinical Trials

Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage

Xe-SAH
Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

An investigator-initiated clinical drug study Main Objective: To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH). Primary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging (DTI). Hypothesis: White matter damage is less severe in xenon treated patients, i.e. global fractional anisotropy is significantly higher in the xenon group than in the control group as assessed with the 1st magnetic resonance imaging (MRI). After confirmation of aSAH and obtaining a signed assent subjects will be randomized to the following groups: Control group: Standard of Care (SOC) group: Air/oxygen and Normothermia 36.5-37.5°C; Xenon group: Normothermia 36.5-37.5°C +Xenon inhalation in air/oxygen for 24 hours. Brain magnetic resonance imaging techniques will be undertaken to evaluate the effects of the intervention on white and grey matter damage and neuronal loss. Neurological outcome will be evaluated at 3, 12 and 24 months after onset of aSAH symptoms Investigational drug/treatment, dose and mode of administration: 50±2 % end tidal concentration of inhaled xenon in oxygen/air. Comparative drug(s)/placebo/treatment, dose and mode of administration: Standard of care treatment according to local and international consensus reports. Duration of treatment: 24 hours Assessments: Baseline data Information that characterizes the participant's condition prior to initiation of experimental treatment is obtained as soon as is clinically reasonable. These include participant demographics, medical history, vital signs, oxygen saturation, and concentration of oxygen administered. Acute data The collected information will contain quantitative and qualitative data of aSAH patients, as recommended by recent recommendations of the working group on subject characteristics, and including all relevant Common Data Elements (CDE) can be applied. Specific definitions, measurements tools, and references regarding each SAH CDE can be found on the weblink here: https://www.commondataelements.ninds.nih.gov/SAH.aspx#tab=Data_Standards.

NCT ID: NCT04533178 Not yet recruiting - Back Pain Clinical Trials

Posterior Lumbar Stress Reaction in Pediatric Patients. Treatment With or Without Soft Spinal Brace?

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

A clinical trial will be conducted comparing healing of a posterior lumbar vertebra stress reaction in children treated either with cessation of sports activities for a period of six weeks and wearing a soft spinal brace 16 hours per day or cessation of sports activities only. Primary outcome is the change in stress reaction on MRI at 6 weeks compared to pre-treatment MRI.

NCT ID: NCT04510870 Not yet recruiting - Infertility Clinical Trials

Iron Deficiency as an Ignored Cause of Infertility

IDI
Start date: August 17, 2020
Phase: Phase 4
Study type: Interventional

Iron deficiency may play a critical role in human infertility, oocyte quality and may even play a role in endometrial receptivity. By correcting iron deficiency, low ferritin values, in infertile women with intravenous iron supplementation, embryo quality and pregnancy rates may improve. The main objective is to evaluate the effect of intravenous iron supplementation on embryo quality (number of good quality blastocysts). Randomized, double blind, parallel group, cross-over study of ferric carboxymaltose compared to placebo (NaCl infusion).

NCT ID: NCT04001699 Not yet recruiting - Multimorbidity Clinical Trials

Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity

IPPGA-RCT
Start date: August 19, 2019
Phase: N/A
Study type: Interventional

The objective of this randomized control trial is to investigate effects and cost effectiveness of interprofessional preoperative assessment among older knee or hip arthroplasty patients. The main hypothesis is that preoperative assessment and optimization have a positive impact on the patents' quality of life and expenditure of social and health care services.

NCT ID: NCT03926468 Not yet recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Liquid Biopsy in Head and Neck Cancer

Start date: August 1, 2019
Phase:
Study type: Observational

Overall survival of patients with head and neck squamous cell carcinoma (HNSCC) remains unsatisfactory due to often advanced clinical stage at diagnosis and high rate of recurrence and second primaries. About 75 % of patients with localized HNSCC are expected to show circulating tumor DNA (ctDNA) pre-treatment. ctDNA reflects tumor genome and disease burden and is termed 'liquid biopsy' (LB) when collected through venous bloodstream. LB has potential to assist in early diagnosis of recurrence and progression, and prediction of response to targeted therapeutic agents. Increased metabolic activity measured in positron emission tomography-computed tomography (PET-CT) is currently the most sensitive technique to detect residual cancer or progression of HNSCC after curative treatment. High metabolically active tumor volume (MTV) is associated with treatment resistance and shows independent prognostic significance. The objective is (i) to investigate whether MTV detected with PET-CT correlates to the pattern and amount of genetic alterations in ctDNA of patients with HNSCC referred to radio- (chemo)therapy (RT/CRT). Another objective is (ii) to determine sensitivity of LB compared to PET/CT in detecting residual tumor 3 months after completion of RT/CRT. Third (iii), genetic landscape in LB and fresh tumor samples will be evaluated to detect resistance genes and targets for immunotherapy and surveillance post-treatment. This prospective study includes 30 patients with stage III/IV HNSCC. Before onset and 3 months from RT/CRT, LB is obtained for next-generation DNA sequencing using a commercial platform. ctDNA and digital droplet PCR will be quantified and compared to MTV in simultaneously acquired PET-CT. The investigators hypothesize that LB could assist or replace PET/CT in response monitoring and detection of recurrence after RT/CRT.