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NCT ID: NCT05581238 Completed - Blood Transfusion Clinical Trials

Validation of a Red Blood Cell Transfusion Prediction Model in a Low Transfusion Rate Population.

TRACK-TCT
Start date: November 1, 2022
Phase:
Study type: Observational

The transfusion risk and clinical knowledge (TRACK) allogeneic blood transfusion prediction model was developed more than ten years ago and demonstrated good discriminative ability in patients with increased risk for allogeneic blood transfusion in an all Italian population. At the time of derivation, dual anti-platelet medication was suggested in the treatment of acute coronary syndrome, but not yet fully implemented. The aim of this study is to externally validate the TRACK blood transfusion prediction model in the cardiac surgery population of Medisch Spectrum Twente Thoraxcentrum Twente. Additionally, the impact of adding the preoperative use of dual anti-platelet medication, as additional predictive factor, to the TRACK blood transfusion prediction model will be investigated.

NCT ID: NCT05581004 Recruiting - Gastric Cancer Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: October 20, 2022
Phase: Phase 1
Study type: Interventional

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

NCT ID: NCT05580562 Recruiting - Glioma Clinical Trials

ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)

ACTION
Start date: January 23, 2023
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.

NCT ID: NCT05579483 Not yet recruiting - Ulcerative Colitis Clinical Trials

Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures

PREDUCTOME
Start date: December 2023
Phase: N/A
Study type: Interventional

A double-blind randomized placebo-controlled parallel trial with two intervention arms and two placebo arms and a period of eight intervention weeks to validate the prediction that prebiotics could induce a higher response in mild UC patients with certain fecal microbiome signatures.

NCT ID: NCT05579327 Recruiting - Clinical trials for Allan-Herndon-Dudley Syndrome

Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)

ReTRIACt
Start date: July 21, 2023
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized phase 3 multicenter placebo-controlled study in at least 16 evaluable male participants diagnosed with MCT8 deficiency. Male participants, from 4 years of age (at randomization) and having demonstrated stable maintenance treatment with tiratricol, will be randomized to receive placebo or tiratricol for 30 days or until reaching rescue criterion (serum total triiodothyronine [T3] > upper limit of normal [ULN] of the participant's normal range, for a sample collected during the 30-day Randomized Treatment Period). The research hypothesis to be tested is that, for participants in the placebo group, removal of tiratricol will lead to an increase of serum total T3 concentration, measured by liquid chromatography with tandem mass spectrometry (LC/MS/MS), above the ULN and requirement of rescue treatment with tiratricol, compared to those who continue to receive tiratricol.

NCT ID: NCT05579106 Completed - Nociceptive Pain Clinical Trials

Nociception and BIS Level Monitoring in COVID-19 Patients in the Intensive Care Unit

NEMO
Start date: November 8, 2022
Phase:
Study type: Observational

Pain (nociception), stress and discomfort are difficult to detect in sedated and intubated patients during mechanical ventilation. In order to improve this several nociception level monitors (NOL) were developed that objectively track nociception in sedated or anesthetized patients. Earlier studies showed that for sedated and intubated patients in the operating room, using such monitors is beneficial in reducing stress hormones and post operative pain scores. In this study the investigators aim to observe whether the NOL could be equally beneficial in managing nociception in sedated and intubated ICU patients.

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: NCT05578768 Recruiting - IBD Clinical Trials

Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data

PrePro
Start date: October 3, 2022
Phase:
Study type: Observational

The proposed study will use a PROM (Patient report Outcome Measurement)-tool in combination with clinical and biochemical data to train and validate a Relapse Prediction Model for individual patients.

NCT ID: NCT05578755 Completed - Clinical trials for Future Self-identification

Evaluation of a Novel Intervention Aimed at Instilling Future-oriented Mindsets and Behaviors Using a Smartphone Application and Immersive Virtual Reality

Start date: October 19, 2022
Phase: N/A
Study type: Interventional

Short-term thinking, or the inability to make informed tradeoffs between immediate benefits and longer-term costs, has been related to a variety of negative or self-defeating behaviors, such as substance use, impulsive decision making, and delinquency, whereas future-oriented thinking tends to be positively associated with positive behaviors, such as self-esteem, planning, and goal-directed behaviors. To bolster people's psychosocial development, the investigators are developing an intervention, FutureU, aimed at instilling future-oriented mindsets and behaviors by strengthening people's identification with who they may be in the future, i.e., their 'future self'. Through the use of a smartphone application (app) and immersive virtual reality (VR), participants interact with a visual representation of their future self. In the present study, the investigators will evaluate the current iteration of this intervention and compare the FutureU app and FutureU VR with each other and with a goal-setting control group. Knowledge and insights gained from this study will be used to further develop the FutureU intervention program and can provide insights for intervention theory building and implementation strategies.

NCT ID: NCT05578677 Active, not recruiting - Barrett Esophagus Clinical Trials

Endoscopic Biopsy Techniques in Barrett's Esophagus Patients

BITE
Start date: June 23, 2021
Phase: N/A
Study type: Interventional

Barrett's esophagus (BE) is a premalignant condition of the distal esophagus, predisposing to dysplasia and esophageal adenocarcinoma. Therefore, in BE patients, current guidelines recommend endoscopic surveillance with four-quadrant biopsies every 2 centimeters of the Barrett's length. These biopsies need to be of optimal quality for adequate histopathological assessment. Larger biopsies can facilitate adequate histopathological assessment because (1) more tissue is available, (2) larger biopsies usually result in less superficial biopsies, with all mucosal layers present in the biopsy specimen, and (3) larger biopsies will ease orientation of the specimen. In a pilot study, the investigators found a median increase of nearly 30% in surface area when the biopsies were obtained by BE-expert endoscopists in comparison with non BE-expert endoscopists. A possible explanation for this difference can be biopsy method or technique. BE-expert endoscopists use the single biopsy method and turn-and-suction technique, whereas the double biopsy method and the advance-and-close technique are the more generally used biopsy techniques within non BE-expert endoscopists. The BITE study is therefore designed to identify the preferred biopsy technique and method in BE patients in order to optimise biopsy quality and histopathological assessment.