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NCT ID: NCT06164951 Enrolling by invitation - Achondroplasia Clinical Trials

A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia

PROPEL3
Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of participation in the QED-sponsored study PROPEL (QBGJ398-001).

NCT ID: NCT06150859 Enrolling by invitation - Bereavement Clinical Trials

Ayahuasca Assisted Psychotherapy for Grief

PSICODUELAYA
Start date: October 15, 2021
Phase: Phase 2
Study type: Interventional

The aim of this study is to compare the effectiveness of an ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment to decrease the severity of grief. A secondary purpose is to assess the effectiveness to prevent Persistent Complex Bereavement Disorder and Prolonged Grief Disorder, and to assess potential changes in avoidance, meaning-making and self-clarity. Subjective effects and Acceptance promoting effects of psychedelic drug are assessed after ayahuasca administration. A non-randomized controlled trial is proposed with three arms involving an experimental group (ayahuasca in concert with psychotherapy) and two control groups (psychotherapy and no treatment) with pretest, posttest and 3 months follow-up.

NCT ID: NCT06138808 Enrolling by invitation - Clinical trials for Epilepsy Intractable

5-SENSE Score Validation Study

Start date: January 9, 2024
Phase:
Study type: Observational

The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.

NCT ID: NCT06127888 Enrolling by invitation - Migraine Clinical Trials

Impementation of the Exercise Recommendations for the Treatment of Primary Headaches: A Qualitative Approach to the Headache Units in Catalonia

RECEPTA
Start date: March 20, 2024
Phase:
Study type: Observational [Patient Registry]

Therapeutic exercise, including aerobic activity and strength training, has shown promise in treating primary headaches with a moderate effect size, despite limited evidence. Implementation requires specialized professionals, infrastructure, and defined care pathways. These strategies are cost-effective for similar chronic pain conditions. More research is needed to better understand the varying effects on headache frequency, duration, and intensity in larger patient samples.

NCT ID: NCT06124222 Enrolling by invitation - Quality of Life Clinical Trials

Prosthetic Rehabilitation and Its Influence on Masticatory Performance and QoL in Patients Treated for HNC

Start date: November 17, 2021
Phase: N/A
Study type: Interventional

The main goal of this clinical trial (pilot study) is to evaluate whether prosthetic rehabilitation modifies objective masticatory performance, subjective masticatory performance, quality of life, salivary flow and pH in patients treated for head and neck cancer before and after the placement of fixed and/or removable prostheses. Hypothesis Prosthetic rehabilitation with fixed and/or removable prostheses modifies objective masticatory performance, subjective masticatory performance, quality of life, salivary flow and pH in non-irradiated patients treated for head and neck cancer compared to irradiated patients. Study population The study population will consist of patients treated for head and neck cancer who are candidates for prosthetic rehabilitation. The type of prosthetic treatment recommended will be determined by a dental expert in the treatment of these patients. Interventions 1. - First session and recruitment: - Oral health status. - Sialometry and salivary pH. - Subjective masticatory performance. - Objective masticatory performance. - Quality of life. 2. - Prosthodontic treatment. 3. - Second session (after insertion of the prosthesis) After an adaptation period of ± 15-30 days from the insertion of the prosthesis, the recordings carried out in the first session will be performed again: - Oral health status. - Sialometry and salivary pH. - Subjective masticatory performance. - Objective masticatory performance. - Quality of life. 4. - Third session (follow-up 6 months) After a period of time of 3 months ± 7 days after the second session, the recordings carried out in the first and second sessions will be performed again: - Oral health status. - Sialometry and salivary pH. - Subjective masticatory performance. - Objective masticatory performance. - Quality of life.

NCT ID: NCT06122636 Enrolling by invitation - Quality of Life Clinical Trials

Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC

Start date: October 3, 2022
Phase: N/A
Study type: Interventional

The study is a Clinical Trial and the main objective is to Evaluate the effects of probiotics on oral complications induced by antineoplastic therapies in patients with head and neck cancer, attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), Faculty of Medicine and Health Sciences Bellvitge campus during the period 2022- 2024. Research question: Is the use of probiotics compared to placebo effective in reducing oral complications produced by antineoplastic therapies in patients with head and neck cancer attended in the radiotherapy service at the Catalan Institute of Oncology (ICO) Hospitalet and the Dental Hospital of the University of Barcelona, Faculty of Medicine and Health Sciences campus Bellvitge during the period 2022- 2024? Study population: Patients attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), (Master of Dentistry in Oncology and Immunocompromised Patients) diagnosed by histological confirmation of head and neck cancer and treated in the last year.Intervention: Patients who agree to participate in the study will be randomized to the intervention or control group. Two visits will be made, the first as a baseline measurement and the second after the end of the intervention. In the first visit they will be given the products either probiotic or placebo, with presentation of a box with 10 sachets. The probiotics contain: Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus. 1 x 10e10 Colony Forming Units (CFU). And the placebo composed of excipients. They are gluten free. Each patient will be given 1 sachet dissolved in water, to take 2-3 minutes of mouthfuls then swallow, after brushing, once a day, for 30 days.

NCT ID: NCT06111014 Enrolling by invitation - Clinical trials for Neurodegenerative Diseases

Continuation Study for Latozinemab

Start date: December 8, 2023
Phase: Phase 3
Study type: Interventional

Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study

NCT ID: NCT06070415 Enrolling by invitation - Treatment Adherence Clinical Trials

Adherence to Exercises for Low Back Pain.

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

This project focuses on the effectiveness of a Chatbot in promoting adherence to home physiotherapy treatment for patients with lumbar musculoskeletal injuries. The use of digital technologies and media are an important option to complement in-person treatment and promote adherence to treatment at home. The research aims to verify whether the use of a Chatbot as a means of communication can produce improvements in patient adherence and clinical results.

NCT ID: NCT06061744 Enrolling by invitation - Gallbladder Cancer Clinical Trials

Robot-assisted vs Laparoscopic vs Open Radical Cholecystectomy for Gallbladder Cancer

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

The gallbladder is the most common primary cancer site among the biliary tracts and its incidence is increasing. Its prognosis is still poor with a 5-year survival of almost 20%. Cholecystectomy is curative in patients with Tis and T1a. For patients with resectable T1b and above disease, radical cholecystectomy is advocated consisting of en bloc resection of the gallbladder, wedge resection of the liver or segment 4b, extrahepatic bile duct, and the regional lymph nodes. The aim of this study is to compare patients who have undergone Robotic, Laparoscopic and Open liver resection with lymphadenectomy for >T1b gallbladder cancers in a case-matched analysis using propensity scores. The primary endpoints are intra- and postoperative outcomes, and the secondary endpoints long-term oncologic outcomes and feasibility and adequacy of minimally invasive versus traditional open approach.

NCT ID: NCT06057324 Enrolling by invitation - Healthy Subjects Clinical Trials

Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The population from Mediterranean countries is abandoning the Mediterranean diet (MD) traditional dietary and lifestyle pattern moving to unhealthier habits because of profound cultural and socio-economic driven lifestyle changes. Families, particularly parents, are responsible for structuring children's early experiences with food and eating as well as for transmitting knowledge of the MD. Educational family approaches can not only lead to more solid food literacy and healthy habits for children in the family but can also improve dietary profiles for adults, thus preventing future health-related problems. There is a lack of adequate study protocol for inducing a positive dietary, environmental and lifestyle behaviour in the family setting. SWITCHtoHEALTHY study aims to evaluate the effects of a multi-component nutritional intervention deployed at family level on the adherence to the MD pattern in families from three Mediterranean countries. A parallel, randomized, single blind controlled multicentric nutritional intervention study will be conducted in 480 families with children and adolescents among 3-17 years from Spain, Morocco, and Turkey over 13 months. Specifically, 160 families per country will be enrolled in a multi-component intervention and allocated to use digital interactive tools, hands-on educational materials and activities for adolescents, easy-to-eat healthy plant-based snacks for children, or a combination of two or three of the components. There will also be a control group that will receive general advice on healthy eating. The intervention study is scheduled to begin in November 2023. Through the digital tools the parents will use an interactive App through which they will receive personalized weekly meal plans while the engagement of all the family will be prompted by using a life simulation game. A set of activities for adolescents based on a learning-through-play approach to be carried out within the family and at school will be developed by adolescents and voluntary schoolteachers through co-creation sessions. The innovative and sustainable plant-based snacks will be produced by local food companies and introduced in the children dietary plan as healthy alternatives for between meals. By using a full-factorial design, the independent and combined effects of each intervention component will be tested by comparing the 7 intervention groups with the control group.