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NCT ID: NCT05661578 Recruiting - Clinical trials for PD-L1-selected Solid Tumors

A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors

SKYSCRAPER-11
Start date: May 4, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected solid tumors whose disease is locally advanced, recurrent, or metastatic and for whom an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.

NCT ID: NCT05571085 Recruiting - Obesity Clinical Trials

Core Stabilization and PNF Exercises on Cor Muscle Activation in Obese Children

Start date: October 28, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to examine the effects of core stabilization and PNF exercises on core muscle activation in obese children.In the study, the initial sample size was calculated as 66 people, under the assumptions that the comparisons between groups would be made with one-way analysis of variance (ANOVA), 3 groups would be included in the study, α= 0.05, β= 0.20 and the effect size would be f= 0.40. The study will be conducted on children between the ages of 10-13 who have a BMI value above the 95% percentile according to age and gender.After recording the sociodemographic information of the individuals, body composition, core muscle activation level, lumbar region muscle endurance, lumbar joint position sense, body image, static and dynamic balances, level of enjoyment of physical activity, physical activity level and pediatric quality of life scale before treatment, 8 weeks of treatment will be measured by the evaluator at the end of the 12-week follow-up period. The level of core muscle activation will be used as the primary outcome measure in the study.

NCT ID: NCT05543200 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

BPH Global Registry

Start date: March 13, 2023
Phase:
Study type: Observational [Patient Registry]

Benign prostatic hyperplasia (BPH) is one of the most common performed surgical procedures in urology. Over the past few decades there have been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been standardized. While data are available for the initial pivotal studies, post-market release data are lacking. Under the umbrella of uCARE, we have started a prospective, ongoing international registry for recording demographics and outcomes for patients undergoing surgical treatments for BPH.

NCT ID: NCT05525897 Recruiting - Soft Skills Clinical Trials

Life Skills 101 Feasibility Study

LEVELUP1
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

In the present study, the investigators aim to examine the feasibility of embedding a classroom-based soft skills intervention within a tertiary curriculum. The primary objective of this study is to assess the acceptability and feasibility of the "Life Skills 101", a novel psychoeducational course for students in higher education. The secondary objective of this study is to evaluate potential effectiveness of the course by measuring students' acquired knowledge and improvement on self-insight. Different methodologies will be used as part of the stage model for behavioral intervention development. In specific, three universities (CY, GR, SP) will run a single-arm study, while the fourth university (NL) will run an RCT pilot study.

NCT ID: NCT05523167 Recruiting - Dermatomyositis Clinical Trials

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

ALKIVIA
Start date: October 12, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

NCT ID: NCT05490524 Recruiting - Cancer Clinical Trials

Smart Living Homes: GATEKEEPER System With Patients With Cancer and Dementia in Cyprus

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

The main objective of the Project is to create a GATEKEEPER, that connects healthcare providers, businesses, entrepreneurs, elderly citizens and the communities they live in, in order to originate an open, trust-based arena for matching ideas, technologies, user needs and processes, aimed at ensuring healthier independent lives for the ageing populations. By 2022, GATEKEEPER will be embodied in an open source, European, standard-based, interoperable and secure framework available to all developers, for creating combined digital solutions for personalised early detection and interventions that (i) harness the next generation of healthcare and wellness innovations; (ii) cover the whole care continuum for elderly citizens, including primary, secondary and tertiary prevention, chronic diseases and co-morbidities; (iii) straightforwardly fit "by design" with European regulations, on data protection, consumer protection and patient protection (iv) are subjected to trustable certification processes; (iv) support value generation through the deployment of advanced business models based on the VBHC paradigm. GATEKEEPER will demonstrate its value by scaling up, during a 42-month work plan, towards the deployment of solutions that will involve ca 40.000 elderly citizens, supply and demand side (authorities, institutions, companies, associations, academies) in 8 regional communities, from 7 EU member states. Recently 3 Asian pilots have been added as a result of the Open Calls. The achievement of the overall objective is supported by the following, among others, specific objective: To execute a series of PILOTS to demonstrate the effect, benefit, value and scalability of the GATEKEEPER solutions around REFERENCE USE CASES COVERING PRIMARY, SECONDARY and TERTIARY PREVENTION, initially deployed in 8 regions of 7 European countries. The Cyprus pilot mainly focuses on the early detection of the condition worsening of cancer and dementia patients by monitoring whether the use of technology can trigger appropriate management, thereby reducing the need for higher acuity care, and even, at times, improving survival by supporting demand-driven solutions through high-quality health mobile systems.

NCT ID: NCT05430971 Recruiting - Clinical trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry

Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare hematologic malignancy. Despite recent advances, at present there is no consensus on the optimal treatment of BPDCN. The optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on BPDCN clinical presentations, diagnostics, treatment regimens and outcomes. Therefore, the objectives of this study are: (1) to build a large database of patients with BPDCN, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.

NCT ID: NCT05420233 Recruiting - Crohn Disease Clinical Trials

The CROCO Study: CROhn's Disease COhort Study

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

The investigators propose to create a prospective Crohn Disease cohort, where patients receiving the most up-to-date therapies with a treat-to-target strategy, will be closely followed to characterize the progression of Crohn Disease by measuring the Lémann Index over time. The goal of the CROCO Study - "Crohn's Disease Cohort Study" is to promote a greater understanding of the long-term evolution of Crohn Disease , to describe prospectively the impact of different therapeutic strategies and develop accurate predictors of bowel disease damage and disability.

NCT ID: NCT05374161 Recruiting - Depression Clinical Trials

An Intervention for Female Breast CANcer: Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain

I-CAN-ACT
Start date: January 20, 2022
Phase: N/A
Study type: Interventional

As a result of the cancer diagnosis and medical therapies, women with breast cancer often encounter debilitating cooccurring psychological and physical symptoms. While pain constitutes one of the most common adverse physical side effects of medical treatment reported by breast cancer patients, the most prevalent psychological symptom they seek psychological help for is depressive symptoms. Acceptance and Commitment Therapy (ACT) in psychosocial oncology care may be particularly beneficial in targeting depression and cancer-related pain. The aim of the I-CAN-ACT project is to examine in a RCT the efficacy of a brief ACT-based intervention for both depression and physical pain (6 online sessions) compared to a waitlist control on various outcomes in women with breast cancer. Outcomes will include quality of life, physical pain intensity and interference, depression, and anxiety in women with breast cancer. These will be assessed at post-treatment and at the 1-month, 3-month, 6-month and 1 year follow-ups (for Marianna Zacharia's PhD thesis, results will be presented until the 3-month follow-up). Also, the Acceptability and Feasibility of the intervention will be assessed. That is, participants' treatment acceptability and adherence to the brief ACT intervention in terms of retention, treatment engagement and satisfaction with each session and with the overall treatment will be assessed. Participants' reasons for dropout will be recorded.

NCT ID: NCT05337631 Recruiting - Oropharynx Cancer Clinical Trials

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

SENIOR
Start date: June 1, 2021
Phase:
Study type: Observational

The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.