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NCT ID: NCT06468527 Recruiting - Cystic Fibrosis Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Adults With CF

CHOICES
Start date: June 3, 2024
Phase: Phase 2
Study type: Interventional

CF is caused by mutations in the gene that encodes the 'Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)' channel. To re-establish the function of this complex chloride channel, typically two to three drug modes of action are needed. To date, clinical studies of CFTR modulators have focused on patients carrying the F508del CFTR mutation, which is present in approximately 80% of CF patients, or gating mutations which are present in 5% of CF patients (gating mutations result in a reduced opening of the CFTR-channel at the cell surface which limits the flow of chloride ions through the CFTR channel). Although CF is a monogenetic disease, the 15% remaining patients represent more than 2000 different rare and mostly uncharacterized CFTR mutations. Multiple pharma companies have one or more CF drugs in their developmental pipeline. However, it is not known which patients may respond to the drugs in the pipeline. It is hypothesized that by using individual patient's intestinal organoids to screen for drug response, a subset of patients with rare CFTR mutations can be identified who will clinically respond to drugs in the developmental pipeline. The Human Individualized Therapy of CF (HIT-CF) project has been designed to further evaluate this hypothesis. The project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 755021. The core of the project consists of a two-step approach to identify patients outside the existing drug label who may also benefit from CFTR-modulator treatment. In the first step of the project (HIT-CF Organoid Study, NTR7520), novel CFTR modulators and their combinations were tested on organoids from over 500 European and Israeli CF patients with rare CFTR mutations to identify patients who are predicted to clinically benefit from these treatments. The second step will evaluate the predicted clinical effect of the CFTR modulators in subjects identified by their organoid response to investigational products. CFTR modulators from the HIT-CF participating pharmaceutical company, FAIR Therapeutics, will be evaluated in the CHOICES clinical study described in this protocol. Data from this clinical study will be compared with the HIT-CF Organoid Study results to validate the organoid model.

NCT ID: NCT06459011 Not yet recruiting - Clinical trials for Chronic Respiratory Disease

Shedding Light on a Forgotten Workforce: Loved Ones of People With Chronic Respiratory Diseases

Start date: June 24, 2024
Phase:
Study type: Observational

This study aims to: i) develop an instrument that assesses the needs of informal carers of people with chronic respiratory diseases (CRD), along diseases' trajectory, and evaluate its measurement properties; ii) identify existing instruments that assess the needs of informal/family carers and their measurement properties, iii) characterize the needs of informal carers of people with CRD and iv) characterize the health literacy of informal carers of people with CRD. The first task will be a systematic review. For the second and third tasks, people with CRD, their informal carers and health professionals will be recruited via the pulmonology services from the hospitals:Unidade Local de Saúde de Gaia/Espinho, Unidade Local de Saúde da Região de Aveiro, and Unidade Local de Saúde de Entre o Douro e Vouga. On task 2, a mixed-methods study will be conducted to characterize the needs of informal carers of people with CRD, as well as their health literacy. On task 3, an instrument that assesses the needs of informal carers of people with CRD will be developed and its measurement properties will be studied. This study is urgently needed to provide meaningful support to this hidden workforce who provides most of the care to people with DRC contributing to guide meaningful supportive care to this population and their loved ones.

NCT ID: NCT06458166 Recruiting - Fatigue Clinical Trials

Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery

Start date: July 1, 2024
Phase:
Study type: Observational

Over the recent years, the increased competitive demands in elite competitive athletes has sparked a heightened interest in monitoring fatigue. Given the nature of the soccer game, athletes may experience low-frequency fatigue. Until recently, this assessment was restricted to in-lab. However, the emergence of new instruments aiming to allow low-frequency assessment to be carried out on a daily basis, in the context of professional teams. This study aimed to analyze the recovery of low-frequency fatigue, jump height and perceptual responses following competition and investigate possible associations between the objective and subjective parameters.

NCT ID: NCT06457698 Active, not recruiting - Clinical trials for Temporomandibular Joint Disorders

Temporomandibular Bioviscosuplementation (Platelet-Rich Plasma Combined With Hyaluronic Acid) After Double-Puncture Arthrocentesis: a Randomized Controlled Trial

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

Intra-articular injections of hyaluronic acid (HA) or platelet-rich plasma (PRP) have been used with temporomandibular joint (TMJ) arthrocentesis to improve lubricative properties and influence regenerative processes. A randomized, controlled clinical trial investigated the benefits of complementary bioviscosuplementation (HA+PRP) in patients submitted to double-portal TMJ arthrocentesis.

NCT ID: NCT06455306 Recruiting - Clinical trials for Peri-implant Mucositis

Erythritol Air Polishing in Mucositis Treatment

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

This study aimed to evaluate the effectiveness of air polishing systems compared to the exclusive use of oral hygiene instruction in the treatment of peri-implant mucositis

NCT ID: NCT06453837 Completed - Wrinkle Clinical Trials

Clinical Study for the Efficacy Evaluation of a Food Supplement

Start date: June 21, 2023
Phase: N/A
Study type: Interventional

The primary aim of this in vivo clinical study is to evaluate the depigmenting effect of an active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter, assessed with the equipment Antera 3D (Miravex, Ireland), after 28 consecutive days of food supplement's once-daily intake, in comparison with the baseline and a placebo. The secondary objective of this study is to evaluate in vivo the depigmenting effect of the same active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter, assessed with the equipment Antera 3D (Miravex, Ireland), after 56 and 84 consecutive days of food supplement's once-daily intake. Other goals of this clinical study are to evaluate in vivo the effect of the same active ingredient incorporated into a food supplement, after 28, 56 and 84 consecutive days of a once-daily intake, in comparison with the baseline and a placebo (1) on skin whitening/brightening through the evaluation of the L* parameter, assessed with the equipment Antera 3D (Miravex, Ireland), (2) on the skin colour homogeneity through the measurement of the ITAº (Individual Typology Angle) parameter, assessed with the equipment Colorimeter® CL400, (3) on the skin tone evenness through the measurement of the standard deviation of the skin colour, assessed with the equipment Colorimeter® CL400, (4) on the skin density of the dermis, measured with the equipment Episcan 35 MHz (Longport Inc, United States), (5) on skin hydration assessed through capacitance measurements with the equipment Corneometer® CM825, (6) on the skin firmness, skin overall elasticity and skin total deformation measured with the equipment Cutometer® SEM 575 (Courage+Khazaka electronic GmbH, Germany), and (7) on skin radiance through clinical evaluation performed by an expert. It is also objective of this clinical study to evaluate (8) subjects' tolerance, acceptability, perception of efficacy and future use/purchase intention towards the food supplements by filling out a subjective evaluation questionnaire after 28, 56 and 84 consecutive days of food supplement's once-daily intake.

NCT ID: NCT06452875 Completed - Pancreatitis Clinical Trials

PRIMARY NEEDLE KNIFE FISTULOTOMY

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Evaluate the outcomes of NKF as an initial method for biliary access.

NCT ID: NCT06452277 Not yet recruiting - Clinical trials for Advanced Non-small Cell Lung Cancer

A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)

SOHO-02
Start date: June 24, 2024
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: - BAY 2927088 twice every day as a tablet by mouth, or - Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment. During the study, the doctors and their study team will: - take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer - check the overall health of the participants by performing tests such as blood and urine tests, and checking - heart health using an electrocardiogram (ECG) - perform pregnancy tests for women - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

NCT ID: NCT06444490 Completed - Oral Health Clinical Trials

Oral Hygiene Among Portuguese Older Adults

Start date: January 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial was to compare two different oral hygiene instruction methods on oral hygiene behavior in older adults. We also wanted to evaluate the self-perception of oral health changes with each instruction method. The main questions we aim to answer were: - Which method has better results in changing oral hygiene habits? - Which method has better results in reducing bacterial plaque? Participants: - Completed a questionnaire about socioeconomic aspects and oral hygiene habits; - Were examined to assess their oral hygiene status; - Completed a questionnaire about self-perception of oral health; - Received oral hygiene instruction (depending on the group: Generalised Approach or Personalised Technique). Two months later, they were assessed again on oral hygiene habits, oral hygiene status, and self-perception of oral health.

NCT ID: NCT06442878 Active, not recruiting - Adult Women Clinical Trials

Benefits of a Belly Dance Psychomotor Intervention

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

The aim of the present study is to analyze the effects of a psychomotor intervention program mediated by belly dance in adult women. This Quasi-experimental study is a controlled trial with one arm. Participants will be allocated to one group which will be i) control and ii) experimental. That is at first i) will attend a control period without intervention (6 weeks) and at second ii) will attend an intervention period participating on the intervention program mediated by belly dance (12 weeks). Participants will be accessed at a baseline, at post control and at post intervention.