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NCT ID: NCT03737305 Recruiting - TMJ Disc Disorder Clinical Trials

RCT of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis

TMJ_Dist
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Articular Disc Displacements are the most common TMJ arthropathy and the articular distraction technique is one of the most common therapeutic resources. It is a technique almost exclusively performed by the physiotherapist and / or dentist, with repeated applications over an extended period of treatment, that can reach several weeks or months, difficult to perform manualy by the patient on an ambulatory basis. Currently there are no ambulatory mandibular exercise devices that aim to execute articular distraction. Thus, the objective of this work was to study, design and develop a device capable of performing and / or assisting patients in the articular distraction maneuver.

NCT ID: NCT03726281 Recruiting - Germ Cell Tumors Clinical Trials

Nivolumab in Platinum Recurrent or Refractory Metastatic Germ Cell Tumors

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

To assess the clinical activity of nivolumab monotherapy, as measured by the investigator-assessed clinical benefit rate (CBR), in patients with platinum-recurrent or platinum-refractory metastatic germ cell tumors (GCT). CBR is defined by sum of complete responses (CR), partial responses (PR) and stable disease (SD) for at least 3 months, with stable or declining tumor markers (αFP and HCG), using Response Evaluation Criteria In Solid Tumors (RECIST 1.1).

NCT ID: NCT03725202 Not yet recruiting - Clinical trials for Giant Cell Arteritis (GCA)

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

Start date: December 12, 2018
Phase: Phase 3
Study type: Interventional

This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved remission in Period 1.

NCT ID: NCT03724019 Recruiting - Quality of Recovery Clinical Trials

Impact of the Use of Ketamine in Laparoscopic Surgery.

Start date: October 1, 2018
Phase:
Study type: Observational [Patient Registry]

In order to improve the postoperative period (namely pain control), several drugs can be used. For instance, ketamine is a general anesthetic that holds strong analgesic properties, yet also owns undesirable effects, in which hallucination phenomena is one the most common indicator. However, slight information is available about the real implication in the quality of the recovery on the use of ketamine for postoperative pain treatment. The quality of the recovery includes several health conditions, such as pain, physical comfort, physical independence, psychological support and emotional state. In recent years, investigations in this field has been attracted the attention by the health professionals, since is an indicator of the quality of post-operative care. To evaluate these parameters, questionnaires have been developed, in which the Portuguese version of Quality of Recovery 15 (QoR-15) is include. This questionnaire evaluates five psychometric dimensions. Therefore, the present study has the main goal, the evaluation of the effect of using ketamine in laparoscopic surgery and the quality of the recovery using the QoR-15 questionnaire.

NCT ID: NCT03724006 Not yet recruiting - Clinical trials for Congenital Heart Defects

Impact of Psychoeducation in Quality of Life of Parents With Children With Congenital Heart Defects

Start date: November 2018
Phase: N/A
Study type: Interventional

Congenital heart defects (CHD) are the most common congenital malformations. Despite the progress made in the last decades in diagnosis and treatment, CHD continues to be associated with significant morbidity and mortality. Several studies have shown a reduction in the quality of life (QoL) of parents of children with CHD, which may affect children too. The main research aim is to assess and to understand the impact of a psychoeducational intervention in QoL of parents with newborns with CHD. We will include parents of inpatient newborns in Hospital Pediátrico Integrado - Centro Hospitalar de São João (HPI - CHSJ) with the diagnosis of CHD, between November 2018 and October 2019. The inclusion criteria considered will be: I) parents of newborns (up to 28 days) with the diagnosis of CHD; II) newborns hospitalized in HPI-CHSJ; III) parents aged ≥ 18 years. Parents of newborns with other co-morbidities associated with CHD and those who do not have good understanding and expression in Portuguese will be excluded. Parents will be divided in 2 study groups: INTERVENTION group (I) and CONTROL group (C). Group I will receive a psychoeducational intervention in addition to the usual routines of the Service. Group C will receive the usual routines of the Service. The psychoeducational intervention, which consists of 2 sessions lasting 90 minutes each one, will be performed as soon as possible after inclusion in the study. Participants will be evaluated in three moments: M1 beginning of the study; M2 4 weeks after the intervention (I) or after enrollment (C) and M3 16 weeks after intervention/enrollment. The primary outcome will be parental QoL, which will be evaluated through the SF36v2 Health Survey. The family impact and the perception of positive contributions will be secondary outcomes. These outcome variables will be assessed by the Impact on Family Scale and the Positive Contributions Scale - Kansas Inventory of Parental Perceptions, respectively. A semi-structured interview will be performed after all quantitative data have been collected. The authors expect to find an increase of QoL and positive contributions and a decrease of family impact in the intervention group comparatively to the control group.

NCT ID: NCT03715166 Recruiting - Clinical trials for Autism Spectrum Disorder (ASD)

Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.

NCT ID: NCT03715153 Recruiting - Clinical trials for Autism Spectrum Disorder (ASD)

Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.

Start date: October 4, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.

NCT ID: NCT03704077 Not yet recruiting - Gastric Cancer Clinical Trials

An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Start date: November 20, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

NCT ID: NCT03701945 Recruiting - COPD Clinical Trials

Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD

PRIME
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

PRIME goal is to early detect and treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD). This is important since COPD accelerates aging and represents major burden worldwide and in Portugal, mainly due to its frequent AECOPD. Pulmonary rehabilitation (PR) is an effective strategy of its management but it is scarce. When AECOPD are early detected and treated, it optimizes patients' outcomes and reduces the burden of COPD, especially if PR is used. However, up to date, there is no model to predict AECOPD for clinical practice. The lung microbiota shows promise to overcome this barrier and inform on COPD trajectory and will be investigated. In addition, despite of most AECOPD being managed in the community, PR is mainly available in hospitals and less than 1% of patients are having access. Thus, community-based PR will be implemented and a clinical decision tool developed for prioritizing who will most benefit from PR, enhancing evidence-based access to PR.

NCT ID: NCT03696810 Recruiting - Clinical trials for NPDR - Non Proliferative Diabetic Retinopathy

Characterization of Retinal Vascular Disease in Eyes With Mild to Moderate NPDR in Diabetes Type 2

CORDIS
Start date: October 17, 2018
Phase: N/A
Study type: Interventional

Characterization of Retinal vascular disease in eyes with mild to moderate NPDR in Diabetes type 2, using novel non-invasive Imaging methods, in a longitudinal, prospective and interventional clinical Study with 2 years of duration (CORDIS).