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NCT ID: NCT06016920 Recruiting - HNSCC Clinical Trials

Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma

Start date: December 19, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC). The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: a phase 1, dose escalation part, testing 3 different doses of VB10.16 in combination with a standard fixed dose of pembrolizumab. The goal of this part is to evaluate the safety and tolerability of the combined treatment and to decide on the dose of VB10.16 to be used in the second part of the trial. In the second part of the trial, a phase 2a, dose expansion part, participants will receive either the highest safe dose of VB10.16 from part 1 or the 3 mg dose both in combination with pembrolizumab. The dose given to each participant will be decided in random. The trial is designed to define the optimal dose of VB10.16 in combination with pembrolizumab for future clinical studies based on the safety, tolerability and anti-tumor effect data generated.

NCT ID: NCT06015451 Recruiting - Brain Concussion Clinical Trials

Exercise in Postconcussion Symptoms and Posttraumatic Headache

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

The goal of this clinical trial is to compare two models of delivery of guided exercise in patients with exercise intolerance after mild head injury. The main question it aims to answer is: • Is a program that includes elements of in-house exercise and follow-up sessions, and repeated treadmill testing, superior to a program with telephone-based follow-up only? Participants will undergo a treadmill test to determine eligibility for the study, and to determine at what intensity level their symptoms worsen (symptom threshold). Thereafter they will exercise 15-20 minutes, 3-5 times per week at 80-90% of the heart rate that was found to be the symptom threshold. One group will receive face-to-face folllow-up and repeated testing, one group will receive telephone-based follow-up only . Researchers will compare these two groups to see if closer follow-up is superior when it comes to recovery from exercise intolerance after 12 weeks of exercise.

NCT ID: NCT06012942 Recruiting - Critical Illness Clinical Trials

Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients

SkrInt
Start date: July 7, 2022
Phase:
Study type: Observational

The primary aim is to study change of critical frailty scale (CFS) and health related quality of life (EQ-5D-5L) in a long-term follow-up of ICU survivors. We aim to identify important ICU related predictors for change in CFS and EQ-5D-5L in long term follow up (1 yr). Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment intensity level, severity score and mortality.

NCT ID: NCT06012435 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer

Start date: February 21, 2024
Phase: Phase 3
Study type: Interventional

This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called sigvotatug vedotin (SGN-B6A), which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

NCT ID: NCT06008756 Recruiting - Arteriosclerosis Clinical Trials

MK-0616 (Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Start date: October 9, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.

NCT ID: NCT06003660 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Brain Neuronal Networks, Chemosensory and Trigeminal Functions in Allo-HSCT

Start date: August 10, 2023
Phase:
Study type: Observational

The goal of this prospective, cohort study is to learn about smell, taste and trigeminal dysfunction in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). The research team hypothesizes that treatment with allo-HSCT will induce: - Distortion of taste and smell and trigeminal functions like cooling, tingling, and burning sensations. - Reduced saliva production leading to oral dryness and dental caries. - Changes in the connectivity of the taste-, smell- and pain-cortical brain regions.

NCT ID: NCT06000384 Recruiting - Clinical trials for Intensive Care Patient

Is Ultrasound Comparable to Chest X-ray in Verification of Intensive Care Patients Enteral Feeding Tube Positioning.

Start date: September 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to investigate methodological if ultrasound is comparable to chest X-ray in verification of intensive care patients enteral feeding tube positioning. The main question to answer is: Is ultrasound a comparable method to chest X-ray in verification of intensive care patients enteral feeding tube positioning.

NCT ID: NCT06000046 Recruiting - Clinical trials for Prostate Cancer Diagnosis

PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients

Start date: December 20, 2023
Phase: N/A
Study type: Interventional

To perform a traditional feasibility clinical investigation, as defined in ISO 14155:2020, to investigate preliminary feasibility, safety, and clinical performance information of a near-final design of the investigational software. This will be performed through a prospective clinical study on biopsy naïve men with suspected prostate cancer examined with MRI at St. Olavs Hospital, Trondheim, Norway, in order to adequately plan an appropriate pivotal clinical investigation.

NCT ID: NCT05993728 Recruiting - Eating Disorders Clinical Trials

Virtual Body Project Groups Led by Peers Versus Clinicians

v-BP
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Eating disorders (EDs) are a group of illnesses associated with significant psychological and physiological consequences. Overall, only 20% of individuals with EDs receive treatment and treatment is effective for only about 25-35% for those who receive care. The development and implementation of effective prevention approaches for those at risk is therefore pivotal. The Body Project is the most effective ED prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. Further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. With this application, the investigators therefore propose to examine the effectiveness of the Body Project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered Body Project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).

NCT ID: NCT05984797 Recruiting - Cancer Clinical Trials

Integrated Short-Term Palliative Rehabilitation in Incurable Cancer

INSPIRE
Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The goal of this intervention trial is to determine if palliative rehabilitation in addition to usual care is more effective than usual care at improving health-related quality of life in patients with incurable solid cancer.