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NCT ID: NCT05155332 Recruiting - Solid Tumors Clinical Trials

A Study to Test Different Doses of BI 1831169 Alone and in Combination With Ezabenlimab in People With Different Types of Advanced Cancer (Solid Tumors)

Start date: March 11, 2022
Phase: Phase 1
Study type: Interventional

This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This study is for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without ezabenlimab. Another purpose is to see whether BI 1831169 can fight cancer. BI 1831169 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1831169 is given to people for the first time. This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with ezabenlimab. Participants who take the combination treatment get BI 1831169 for up to 3 months and ezabenlimab for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Ezabenlimab is given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by BI 1831169 or ezabenlimab.

NCT ID: NCT05155254 Active, not recruiting - Metastatic Melanoma Clinical Trials

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

Start date: May 17, 2022
Phase: Phase 3
Study type: Interventional

Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.

NCT ID: NCT05155007 Completed - Healthy Clinical Trials

A Study in Healthy Adult Participants to Assess the Effects of Ciclosporin Administration on Rilematovir

Start date: December 10, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetic (PK) of a single-dose of rilematovir co-administered with a single-dose of ciclosporin compared to a single-dose administration of rilematovir alone.

NCT ID: NCT05154305 Recruiting - Rehabilitation Clinical Trials

Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

Start date: April 2, 2019
Phase: N/A
Study type: Interventional

Recent numbers display a 85% survival-rate in children after a very harmful disease such as cancer. However, the survivors still experience mild to severe side effects of the primary disease or treatment. A long time follow-up in the University Hospital of Ghent in children with cancer displays important long term side effects such as: reduced muscle strength; reduced endurance capacity; reduced exercise tolerance; fatigue; disturbed body composition with increased risk for obesity and/or diabetes and osteoporosis; and neuropathic damage and myopathy. These physical complaints have a significant impact on the activities and participation in daily living. The purpose of this interventional study is to create a rehabilitation program for children after acute cancer treatment. The goal is to minimalize the previous described long term side effects of the disease. The current study should allow us to determine the effects of the intervention at the level of functioning, activities and participation. In addition, we account for the environment and personal factors as described by the International Classification of Functioning, disability and health (ICF-criteria). The study population consists of children between 8 and 11 years and adolescents of 12 to 21 years old. All participants receive a multidisciplinary treatment for 4 months, guided by a team which includes: oncologist, rehabilitation doctor, physical therapist, dietitian, psychologist, and occupational therapist. At the beginning of the multidisciplinary program, the participants receive psychoeducation, diet advice, tips for participation, fatigue, and psychological well-being. In general, the rehabilitation program focusses on reintegration at school and leisure activity. After the first assessment, an individually adjusted physical program consisting of strength and endurance training will be made. This physical program will be executed 3 times a week, 2 times guided by a physical therapist at the University Hospital or at a private practice, and ones a week by themselves at home recorded by an activity tracker. Follow-up is foreseen on monthly basis. Participants will undergo assessment 3 times: 1) baseline (T0); 2) after 4 months treatment (T1); 3) after 1 year follow-up (T2). The purpose of this program is to encourage patients at risk for increasing their healthy habits, exercise and participation in order to decrease long-term (side) effects.

NCT ID: NCT05153993 Completed - Rehabilitation Clinical Trials

Effect of Stretching on Visco-elastic Behaviour of the Fascia Plantaris in a Healthy Population

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

RCT with two arms: (1) stretch fascia plantaris (6 weeks, n=30) (2) control (n=30); Outcome parameters: ROM ankle and first toe; visco-elastic behaviour of the fascia plantaris determined by means of myotonometry Study protocol: Outcome parameters were evaluated before and after the intervention/control with a 6 weeks interval. All participants were screened bilaterally and for the participants assigned to the intervention group stretching was only performed on the dominant side

NCT ID: NCT05153980 Completed - Healthy Clinical Trials

The Impact of Blood Flow Restriction Within Warm-up.

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

Sixty athletes will be randomized in two groups; (1) an experimental group and (2) a control group. Both groups will undergo the following procedure: Moment 1: 1. Baseline testing: countermovement jump, 25m sprint and strength assessment of the Hamstrings and Quadriceps muscle. 2. Short warm-up (approximately 4 minutes), which will be completed with blood flow restriction cuffs (experimental group) or without (control group) 3. Post testing: same tests as performed in baseline. Moment 2: 1. Baseline testing: stiffness measurements of the Biceps Femoris Long Head via Shear Wave Elastography. 2. Short warm-up (approximately 4 minutes), which will be completed with blood flow restriction cuffs (experimental group) or without (control group) 3. Post testing: same tests as performed in baseline. Both moments of testing as well as the order in which the performance tests take place are randomized.

NCT ID: NCT05153876 Completed - Migraine Disorders Clinical Trials

An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients

NLPH-OPEN
Start date: October 11, 2021
Phase:
Study type: Observational

Headache disorders are among the most prevalent medical conditions worldwide. The diagnosis of headache disorders is based on medical history taking. Digital solutions such as natural language processing (NLP) may be of aid to understand the linguistic aspects of headache attack and headache related disability descriptions by patients. Participants will provide a written description of their headache disorder. The results will hopefully lead to a better understanding of the potential use of NLP in headache disorders.

NCT ID: NCT05153239 Recruiting - Clinical trials for Relapsed Small Cell Lung Cancer

Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)

Start date: July 22, 2022
Phase: Phase 3
Study type: Interventional

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

NCT ID: NCT05152524 Recruiting - Ischemic Stroke Clinical Trials

Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

DISTALS
Start date: March 25, 2022
Phase: N/A
Study type: Interventional

The objective of the DISTALS Study is to evaluate the safety and effectiveness of the Tigertriever 13 Revascularization Device in restoring blood flow in the neurovasculature by removing thrombus in patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO), as compared to medical management.

NCT ID: NCT05152147 Recruiting - Clinical trials for Esophageal Adenocarcinoma

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

HERIZON-GEA-01
Start date: December 2, 2021
Phase: Phase 3
Study type: Interventional

This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).