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NCT ID: NCT05362370 Enrolling by invitation - Clinical trials for Craniofacial Abnormalities

Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness

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

The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-center trial with a long-term follow-up (24 months) of study participants.

NCT ID: NCT05352919 Enrolling by invitation - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus

EMERALD
Start date: June 10, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

NCT ID: NCT05350033 Enrolling by invitation - Clinical trials for Substance-Related Disorders

Transcranial Direct Current Stimulation on Inhibitory Control in Addictions.

Start date: April 5, 2021
Phase: N/A
Study type: Interventional

The research in neuroscience of the last 20 years is defined, in addition to continuing to advance in the field of behavioral and pharmacological therapy, by the birth and development of a new therapeutic category, called neuromodulation. Neuromodulation offers the possibility of producing changes in the Nervous System (SN) and therefore, in behavior, in addition to lasting over time. One of the most used non-invasive neuromodulation techniques is transcranial direct current stimulation (tDCS). The benefits of tDCS are promising and varied, so it is a potential neurorehabilitation tool, which has also shown its greatest effectiveness when accompanied by complementary rehabilitation treatment. The present study focuses on the effect of tDCS on addiction. Specifically, there is a great problem with the high rates of relapse presented by those individuals who try to abandon addictive behavior. Therefore, the maintenance of the abstinence period is the central theme of addiction research and the main challenge of rehabilitation at present. For that aim, the intervention will be carried out in a sample in the intermediate phase (internal) in the NOESSO (No EstáS Sólo) therapeutic community (Almería, Spain), between day 15 after arrival and the first day to leave on leave (day 45-60). The research will be made up of a previous period of selection and collection of data related to addiction, together with two phases or moments of correlative intervention and evaluation. Users will receive a bilateral (F3/F4) and repeated stimulation of 2 mA intensity for 20 min each, that is, every 24h for 5 consecutive days in each phase. Through this procedure, the aim is to seek to increase adherence to treatment in the early intervention phase and decrease the dropout rate due to the enhancement of inhibitory control. On the other hand, in the second phase, advanced intervention is sought to reduce craving, through an improvement in inhibitory and emotional control at the time of returning to the context of real consumption. In order to increase the knowledge about intra-individual differences in the effect of tDCS, researchers will compare the early intervention (Phase 1, at the begging of the rehabilitation process) with the advanced intervention (Phase 2, right before the first leave).

NCT ID: NCT05327959 Enrolling by invitation - Clavicle Fracture Clinical Trials

A.L.P.S. Clavicle Plating System PMCF

Start date: May 13, 2022
Phase: N/A
Study type: Interventional

A commercially available product clinical study which aims to confirm the safety, performance, and clinical benefits to the patient of the ALPS Clavicle Plating system for both the implant itself and the instrumentation used during surgery.

NCT ID: NCT05320354 Enrolling by invitation - Clinical trials for Periprosthetic Joint Infection

Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID

MID
Start date: April 25, 2022
Phase:
Study type: Observational

The primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity.

NCT ID: NCT05319145 Enrolling by invitation - Prostate Cancer Clinical Trials

PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study)

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

The PROFIT study has two complementary aims. The first aim is to compare, in a cohort study enrolling N=257 older adults (>65 years) with lung, gastrointestinal and prostate cancer, different easy measures of frailty (Geriatric 8 questionnaire (G8), Short physical Performance Battery (SPPB) and the IF-VIG), testing their ability to predict survival, functional status (ECOG, Barthel Index), quality of life (EuroQol5D) and resources utilization (visits, hospital admissions, treatments) at 3, 6 and 12 months. The second aim, which motivates the registration in ClinicalTrials.gov, is to conduct a randomized controlled trial (RCT) enrolling N=134 patients per group, with similar characteristics to those enrolled for aim 1, but with mild-moderate frailty (G8≤14 points); we will compare a multi-component CGA-based intervention including physical exercise and nutritional recommendations with usual care, measuring the impact on the same outcomes as for aim 1, at 3 and 6 months. The use of ad hoc eHealth solutions (App/platform for exercise) will foster patients' empowerment and sustainability of the intervention. We will also assess patients, caregivers, and professionals' experience with the intervention through focus groups. Participants will be recruited from outpatients and from post-acute care units.

NCT ID: NCT05303532 Enrolling by invitation - Cancer Clinical Trials

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab

ROSY-D
Start date: April 19, 2022
Phase: Phase 3
Study type: Interventional

The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

NCT ID: NCT05301894 Enrolling by invitation - Clinical trials for Epileptic Encephalopathy

Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Steamboat 2
Start date: June 7, 2022
Phase: Phase 2
Study type: Interventional

The primary objective for this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS).

NCT ID: NCT05277649 Enrolling by invitation - Clinical trials for Cervical and Mandibular Pain and Disorders in Wind Players

Prevention of Musculoskeletal Injuries in Musicians

Start date: February 23, 2022
Phase: N/A
Study type: Interventional

Musicians are a group with a high prevalence of musculoskeletal injuries. In particular, wind musicians, due to their playing requirements, are prone to suffer from cervical and mandibular alterations. For this reason, a specific exercise programme has been designed with the aim of analysing its effectiveness in improving these regions.

NCT ID: NCT05268146 Enrolling by invitation - Physical Activity Clinical Trials

Earlier Elderly People in Urban Areas

Start date: February 1, 2022
Phase:
Study type: Observational [Patient Registry]

Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050. The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in urban areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions. To achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition, and sarcopenia), and conduct focus groups including young seniors from urban areas, and stakeholders, to determine their needs, interests, and barriers for pursuing healthy lifestyles. Based on the information obtained in the diagnosis and focus groups, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment.