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NCT ID: NCT05720871 Recruiting - Stroke Clinical Trials

Treatment of Chronic Post-stroke Oropharyngeal Dysphagia With Paired Stimulation

ICI20/00117
Start date: November 28, 2022
Phase: N/A
Study type: Interventional

According WHO, oropharyngeal dysphagia (OD) is a prevalent post-stroke (PS) condition involving the digestive system (ICD-10: I69.391) and an independent risk factor for malnutrition and pulmonary infection; and leads to greater morbimortality and healthcare costs and poorer quality of life (QoL). Currently, OD therapy is mainly compensatory, with low rates of compliance and small benefit, and there is no pharmacological treatment, so new treatments that improve patients' condition are crucial. PS-OD patients present both oropharyngeal sensory and motor deficits, so neurorehabilitation treatments which target both could be optimum. Benefits of paired peripheral sensory stimulation with oral capsaicin and of central motor noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) will be studied. Pairing pharmacological peripheral and central stimulation may produce greater benefits. The main aim of the project is to study the efficacy of two novel protocols of paired stimulation on PS-OD patients. The investigators will assess whether 5-day application of tDCS/capsaicin or rTMS/capsaicin in the chronic phase of stroke, will improve PS-OD. One RCT (200 patients in the chronic stroke phase divided in 4 study arms) will assess changes in swallow safety, biomechanics and neurophysiology of the swallow response, hospital stay, respiratory and nutritional complications, mortality and QoL.

NCT ID: NCT05720429 Recruiting - Mental Health Issue Clinical Trials

A Psychoeducational Intervention to Prevent the Psychological Impact of COVID-19 Pandemic in Primary Care Workers

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

The goal of this quasi-experimental pragmatic study is to design, implement and evaluate a psychoeducational group intervention aimed at preventing the negative consequences of the COVID-19 pandemic on the psychological wellbeing and mental health of primary care healthcare workers. The experience will be carried out in real clinical practice conditions and our purpose is to evaluate it not only in terms of clinical effectiveness but, especially, the terms of feasibility, usefulness, and possibility of this intervention being integrated into the usual practice in primary care centers. There will be two types of participation and a mixed quantitative-qualitative methodology. On one hand, the healthcare workers that will receive the intervention and participate in the study by responding to various before and after online surveys with standardized scales. On the other hand, the community psychologists in charge of implementing the intervention, having received guidelines and training, will help gather the participants' data and will provide their perceptions, assessments, and opinions on the program through other questionnaires. After the intervention, a selection of both healthcare workers and psychologists will participate in qualitative in-depth, or group interviews to explore the nuances of their perceptions of the program. The results will allow the investigators to know the usefulness and effectiveness of the intervention and, above all, to model and improve its design and implementation strategy, and promote its generalization beyond the framework of this project.

NCT ID: NCT05720117 Recruiting - Solid Tumor Clinical Trials

Study of PYX-201 in Solid Tumors

Start date: March 14, 2023
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the recommended dose(s) of PYX-201 for participants with relapsed/refractory (R/R) solid tumors.

NCT ID: NCT05719493 Recruiting - Fibromyalgia Clinical Trials

Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)

SYNCHRONIZE +
Start date: October 4, 2021
Phase: N/A
Study type: Interventional

Chronic pain, fatigue and insomnia are classical symptoms of Fibromyalgia and Chronic Fatigue Syndrome, affecting seriously life quality. Non-pharmacological multicomponent approach is gaining relevance in Fibromyalgia treatment. However, nutrition and chronobiology are often not approached in-depth despite their potential. Furthermore, programs addressed to Chronic Fatigue Syndrome are still scare. This study aims to evaluate the effectiveness of a compact multidisciplinary group intervention based on nutrition, chronobiology and physical exercise in the improvement of lifestyle and life quality in Fibromyalgia and Chronic Fatigue syndrome.

NCT ID: NCT05719259 Recruiting - Clinical trials for Ventilator Associated Pneumonia

Perpetual Observational Study - Ventilator Associated Pneumonia

POS-VAP
Start date: August 3, 2022
Phase:
Study type: Observational [Patient Registry]

Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. It is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics. Options to help prevent or treat this disease are in development and will require evaluation in future clinical trials. The goal of POS-VAP is to build and continuously train a network of ICUs to be prepared for doing these trials, to facilitate their execution.

NCT ID: NCT05718700 Recruiting - Clinical trials for Chronic Hepatitis D Infection

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Start date: February 7, 2023
Phase:
Study type: Observational [Patient Registry]

The main goal of this study is to collect post marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide.

NCT ID: NCT05718557 Recruiting - Solid Tumor Clinical Trials

Study of PYX-106 in Solid Tumors

Start date: May 23, 2023
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.

NCT ID: NCT05718323 Recruiting - Clinical trials for SCLC,Extensive Stage

Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC

RAISE
Start date: December 20, 2023
Phase: Phase 2
Study type: Interventional

RAISE is an international, multicentre, single-arm phase II trial. The trial treatment consists of the addition of niraparib, 200 mg orally once daily to anti-PD-L1 antibody maintenance. The primary objective of this trial is to assess the clinical efficacy of the addition of niraparib to anti-PD-L1 monoclonal antibody maintenance treatment in patients with SLFN11-positive ED-SCLC which has not progressed following standard first-line chemo-immunotherapy.

NCT ID: NCT05718297 Recruiting - NSCLC, Stage III Clinical Trials

Brigatinib Post Definitive Chemo-radiotherapy in Patients With ALK-fusion Non-small Cell Lung Cancer

BOUNCE
Start date: June 7, 2024
Phase: Phase 2
Study type: Interventional

BOUNCE is an international multicentre randomised phase II trial. The trial treatment consists of brigatinib 180 mg once daily p.o., with seven day lead-in at 90 mg once daily, for 3 years or until progression of disease. The primary objective of this trial is to evaluate the efficacy in terms of progression-free survival (PFS) for brigatinib consolidation, compared to observation/durvalumab, in patients with unresectable stage III NSCLC and ALK-rearrangement who completed definitive chemo-radiotherapy without disease progression.

NCT ID: NCT05717478 Recruiting - Alveolar Bone Loss Clinical Trials

Regeneration of Alveolar Sockets With rhBMP-2-loaded Bovine Bone Mineral

PROTEOGRAFT
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Aim of the present investigation will be to evaluate the efficacy and safety of a granulate of rhBMP-2- loaded bovine bone mineral (rhBMP-2-BBM) as alveolar bone regeneration procedure following tooth extraction. Forty (40) patients (both sex; age 18 years and older) requiring extraction of one (1) hopeless tooth (incisor, canine or premolar with loss of bone height of 5 mm or more in buccal alveolar wall), followed by alveolar bone regeneration (ABR) and placement of an endosteal implant will be enrolled into the study. After exodontia, participants will be randomized and divided into two groups: in Experimental Group the socket will be grafted with rhBMP-2-BBM granules (1.0-0.25 mm); in Control Group the sockets will be grafted with Bio-Oss granules (1.0-0.25 mm) and covered with porcine collagen barrier membrane (Bio-Gide). The end of the study will be fixed at the implantation surgery, seventeen (17) weeks after exodontia an ABR. Cone beam computed tomography (CBCT) scans will be made, immediately after (0), and sixteen (16) weeks after exodontia an ABR and the gain in alveolar bone height will be estimated and used as the primary outcome for comparison of both groups. As secondary efficacy outcomes the change in alveolar bone width estimated from the CBCT scans; initial (0) and at seventeenth (17th) week after tooth extraction; the change in dental arch dimensions estimated from tridimensional models obtained from intraoral scans at one week before (-1) and sixteen (16) weeks exodontia an ABR; and the amounts of new bone, remnant material and connective tissue histomorphometrically measured in a bone biopsy collected during the implantation surgery at seventeenth (17th) week, will be considered. Healing of gingival tissues at first (1st) and second (2nd) week and incidence of adverse reactions at first (1st), second (2nd) and sixteenth (16th) week, are used as secondary safety outcomes.