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NCT ID: NCT06082427 Completed - Chronic Pain Clinical Trials

Impact of Virtual Reality Hypnosis Before an Invasive Medical Procedure for Patients With Chronic Pain

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

Management of chronic pain involves an array of tools, such as radiofrequency thermocoagulation (Rf-Tc). Like many other invasive procedures, Rf-Tc can generate an increase in pain perception and anxiety levels. Virtual reality hypnosis (VRH) is a promising tool in managing anxiety and pain. Nevertheless, its effectiveness has not been investigated in patients with chronic pain goig througha Rf-Tc procedure. The goal of this study is to evaluate the effectiveness of VRH on self-assessed anxiety in patients with chronic pain having to undergo an act of Tf-Rc. Patients were randomly assigned into two groups: VRH or Control (usual care). Assessment were carried-out at 4 periods of time: T0 (the week before the Rf-Tc); T1 (pre-intervention the day of the Rf-Tc); T2 (post-intervention the day of the Rf-Tc); and T3 (post-Rf-Tc). Medical and socio-demographic data, immersive tendencies pain, anxiety, and satisfaction were assessed at each time points.

NCT ID: NCT06082167 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

STELLAR-305
Start date: November 30, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.

NCT ID: NCT06082037 Recruiting - Clinical trials for Lung Transplant Rejection

A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction

ROCKaspire
Start date: October 10, 2023
Phase: Phase 3
Study type: Interventional

This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.

NCT ID: NCT06081530 Recruiting - Healthy Clinical Trials

A Study in Healthy Men to Test How Well Different Doses of BI 3802876 Are Tolerated

Start date: October 24, 2023
Phase: Phase 1
Study type: Interventional

The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers. The primary objective is to descriptively assess the frequency of drug-related adverse events (AEs) in subjects treated with BI 3802876, as compared to placebo. The secondary objective is to descriptively assess pharmacokinetic parameters.

NCT ID: NCT06080633 Recruiting - Edentulous Jaw Clinical Trials

Facial Prediction Technology for Edentulous Patients

Start date: June 1, 2023
Phase:
Study type: Observational

According to data from the World Health Organization, approximately 160 million people worldwide are edentulous. The incidence increases with age, and the proportion of edentulous patients is higher in the population aged 60 and above. Loss of teeth or edentulism can affect facial appearance, causing people to feel self-conscious and loss confidence in social situations, and even lead to psychological illnesses. Therefore, edentulous patients not only pay close attention to the recovery of oral function but also attach great importance to facial contour improvement. For a long time, due to technological limitations, clinicians have been unable to depict the changes in facial contour after implant placement for patients before surgery. However, with the development of artificial intelligence technology, deep learning-based methods for predicting soft tissue facial deformation have made this mission a possibility. This study established a multi-modal dataset for edentulous patients before and after implant restoration to lay the foundation for predicting facial contour changes after implant treatment. A graph generative adversarial network based on multi-modal data was proposed to achieve fast and high-precision facial contour prediction. To address the common challenges of slow computation and excessive computational resource consumption in current triangular mesh deformation simulation methods, this project innovatively proposed a graph generative adversarial network that uses multi-modal data and incorporates self-attention mechanisms to achieve fast and high-precision facial contour prediction for edentulous patients after implant restoration.

NCT ID: NCT06080178 Recruiting - Clinical trials for Hypotension During Surgery

Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction

GDFT DIEP-flap
Start date: November 23, 2023
Phase: Phase 4
Study type: Interventional

Adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery requires maintaining blood pressure above 100 mmHg and avoiding excessive fluid administration. This study aims to determine whether the use of a measurement of preload dependency (Pulse Pressure Variation = PPV), can guide fluid therapy and if it decreases the risk of flap oedema. For this purpose, two fluid management strategies will be compared: - Static intraoperative fluid management: Administration of crystalloid fluids is limited to 5ml/kg/h - Dynamic intraoperative fluid management: Crystalloid fluids are only administered if PPV exceeds 12% The purpose of this study is to compare the static and dynamic (= targeted) fluid strategy and to evaluate the effect on flap oedema and flap perfusion.

NCT ID: NCT06079359 Recruiting - Hypophosphatasia Clinical Trials

Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP

MULBERRY
Start date: May 14, 2024
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.

NCT ID: NCT06079281 Recruiting - Hypophosphatasia Clinical Trials

Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa

HICKORY
Start date: January 3, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.

NCT ID: NCT06079021 Not yet recruiting - Sarcopenia Clinical Trials

COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device

COOLEY
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

A Prospective, Single-Center trial, in Patients With Acute on Chronic Liver Failure. Study of Standard Medical Care Plus CytoSorb® Compared to Standard Medical Care Alone in a historical group.

NCT ID: NCT06077864 Recruiting - Obesity Clinical Trials

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

Start date: November 17, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have a body mass index (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.