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NCT ID: NCT04635410 Recruiting - NO CONDITIONS Clinical Trials

Improving Ultrasound Based Prediction of Delivery Mode

Start date: February 3, 2020
Phase:
Study type: Observational [Patient Registry]

The progress of labour is traditionally determined by regular vaginal examinations (VEs) to assess the cervix (neck of the womb) and the baby's head position. Such examinations can be uncomfortable and risk causing infection to the baby or mother's womb. The findings are subjective, can be unreliable and cannot be recorded for later review and analysis. The novel, non-intrusive "transperineal ultrasound" technique has been developed utilising existing scanning machines normally found on a delivery unit, with the ultrasound probe placed outside the woman's vagina. This allows objective, recordable measurements creating images that can be captured and stored electronically. This is a prospective longitudinal observational cohort study in nulliparous term (37-42 weeks) labouring women. This study aims to improve the prediction of intrapartum Caesarean Delivery (ICD). The study contains ultrasound and clinical assessments: Transabdominal Ultrasound to measure: Umbilical and Middle Cerebral Artery Doppler, fetal head position and Amniotic Fluid Index (AFI). Transperineal Ultrasound to assess: Head Perineum Distance (HPD), Caput Succedaneum and moulding. Digital vaginal examination by a caregiver: to measure cervical dilatation. Primary outcome: • Mode of delivery Secondary outcome: • Time to delivery Neonatal outcomes: • Apgar score, cord pH level, gender, fetal birth weight, neonatal unit admission within 24 hours, neonatal morbidity.

NCT ID: NCT04635163 Completed - Mental Disorders Clinical Trials

Ideation Trajectories and Suicide Attempts in Adolescents With Psychiatric Disorders in Chile

Start date: March 19, 2018
Phase:
Study type: Observational

This project seeks to evaluate the trajectories of suicidal ideation and attempts in adolescent patients with psychiatric disorders in secondary care controls in the Maule region, in relation to clinical factors (depressive symptoms, anxiety, stress, psychiatric comorbidity, mistreatment or abuse, history of psychiatric disorders and pharmacological treatments); psychological (parenting styles, impulsivity, barriers in seeking help and emotional regulation), and neuropsychological (executive function-decision making).

NCT ID: NCT04634006 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Home-Based tDCS in Children With ADHD: A Randomized, Sham-Controlled tDCS and fNIRS Study

Start date: November 5, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy of twenty daily sessions of home-based tDCS over the left DLPFC, right IFG on attention and response inhibition in children with ADHD. Investigators hypothesize that multiple sessions of tDCS will induce a greater and long-term effect on attentional and/or inhibitory response in children with ADHD. In addition, this study seeks to get a better understanding of the mechanisms of tDCS using fNIRS.

NCT ID: NCT04631939 Recruiting - Psychotic Disorders Clinical Trials

Metacognitive Training as a Serious Game

Macu'ta
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The project aims to evaluate the efficacy of a therapeutic video game that incorporates elements from metacognitive training on delusions and jumping-to-conclusions in patients with psychotic disorders.

NCT ID: NCT04618250 Completed - Schizophrenia Clinical Trials

Improving Physical Health in Patients With Psychiatric Disorders in General Practice (SOFIA)

SOFIA
Start date: November 6, 2020
Phase: N/A
Study type: Interventional

People with a severe mental illness (SMI) have an increased risk for premature mortality, predominantly due somatic health conditions. Evidence indicates that prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (SOFIA model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The primary outcomes are description of study feasibility (recruitment and retention) and acceptability. The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period. If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.

NCT ID: NCT04616157 Completed - Inflammation Clinical Trials

Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial

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

The primary objective of this study is to test the feasibility and efficacy of Internet-delivered Cognitive Behavioral Therapy (CBT) for adolescents (13 - 17 years) with sleep problems (ICBT-I). All participants will receive ICBT-I for six weeks. The investigators will also evaluate the effect of the intervention on comorbid psychiatric symptoms and function.

NCT ID: NCT04612777 Completed - Bipolar Disorder Clinical Trials

A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses

ODR
Start date: June 15, 2014
Phase: N/A
Study type: Interventional

Insufficient community-based support after inpatient discharge for persons with serious mental illnesses (SMI) may lead to re-hospitalization, excessive criminal justice involvement, homelessness, and an inability to embrace recovery. In fact, many of these especially vulnerable persons find themselves in a cycle of repeated hospital stays, arrests, and even homelessness, with little support for real recovery. Public mental health systems are struggling to address these problems. Evidence-based, comparatively inexpensive, time-limited community support models are needed to reduce institutional recidivism and facilitate recovery. The Georgia chapter of the National Alliance on Mental Illness (NAMI-GA) developed Opening Doors to Recovery (ODR), and we have collected extensive preliminary data on it. ODR is now being tested in a randomized controlled trial (RCT) taking place in southeast Georgia where ODR was first developed. The primary goals of ODR are to prevent institutional recidivism (i.e., going back into the hospital) and to promote recovery among persons with SMI like schizophrenia and bipolar disorder. The ODR intervention is comprised of several components that work together to address barriers to successful integration into the community among individuals with SMI and repeated inpatient hospitalizations. A team of 3 specially trained "Community Navigation Specialists" (CNSs, also called Navigators) provides intensive, mobile, community support to persons with SMI with a defined history of inpatient recidivism (i.e., repeated hospital stays). We are carrying out a fully powered trial of ODR in a 7-county catchment area in southeast Georgia, which is an ideal real-world location to carry out the study. During the 5-year study period, we will randomize 240 persons with SMI and a history of ≥2 inpatient stays in the past 12 months to ODR (n=120, followed for 12 months, with a maximum CNS caseload of 40) versus community care in traditional intensive case management or case management (ICM/CM, n=120). Assessments are conducted at baseline (just before hospital discharge), and at 4, 8, 12, and 18 months.

NCT ID: NCT04612192 Recruiting - Sleep Disorder Clinical Trials

Light Therapy for Chronic Insomnia in General Practice

Insolux
Start date: April 13, 2021
Phase: N/A
Study type: Interventional

- Sleep disorders, especially insomnia - Attention deficits (or disorders), daytime somnolence and drug dependence - The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice

NCT ID: NCT04608123 Completed - Clinical trials for Parkinson's Disease (Disorder)

Effect of Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease

PSYCHOSTIM
Start date: May 1, 2020
Phase:
Study type: Observational

Retrospective, monocentric, observational study designed to evaluate the effects of Bilateral Subthalamic Nucleus Deep Brain Stimulation (DBS STN) on Neuropsychiatric fluctuations in Patients with Parkinson's Disease (PD)

NCT ID: NCT04604574 Completed - Clinical trials for Substance Use Disorders

Evaluating the Integration of Indigenous Healing With Principals of Seeking Safety for Treatment of Indigenous Patients With a History of Trauma and Active Substance Use Disorder.

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

Background: The negative health outcomes experienced by Indigenous peoples may be understood as direct consequences of colonization. One of the key consequences of the colonial influence on Canada's Indigenous peoples has been intergenerational trauma (IGT). Indigenous communities in Canada face significant challenges with IGT, which often manifest in substance use disorders (SUD). Indigenous communities have identified SUD as one of their greatest health challenges(Maté 2009), with some Northern Ontario First Nations communities experiencing SUD rates of 70% (Calveson 2010). Most Elders, traditional healers, and Indigenous scholars agree that connecting treatment to culture, land, community, and spiritual practices is a pathway to healing trauma and SUD for Indigenous peoples. Recent work by Dr. Teresa Naseba Marsh has demonstrated that Indigenous Healing and Seeking Safety (IHSS) model for trauma therapy can be effectively combined for the treatment of Indigenous patients with a history of trauma and SUD. Seeking Safety incorporates the inclusion of the mind, body, spirit, and self-awareness during treatment, and the perspective of Seeking Safety is convergent with traditional Indigenous healing methods. Benbowopka Treatment Centre is a residential treatment site operated by Mamaweswen, located in the North Shore Tribal Council in Blind River, Ontario. Benbowopka's mandate is to provide treatment for Indigenous clients with trauma and SUD. They are also implementing a culturally sensitive program grounded in IHSS methodology for the treatment of Indigenous patients' trauma and SUD. Through our current collaboration with Benbowopka and Mamaweswen the applicants have collected baseline data from client files to establish historical outcomes going back three years. In 2016, we began the collaborative implementation of the Indigenous Healing and Seeking Safety (IHSS) model for trauma therapy for clients at Benbowopka. Objective: The purpose of this proposal is to evaluate the effectiveness of the IHSS intervention which blends Indigenous Healing Practices and a mainstream treatment model, Seeking Safety for the treatment of Indigenous patients with a history of trauma and SUD. Methodology: In collaboration with the North Shore Tribal Council and the Benbowopka Treatment Center, we propose a prospective evaluation of IHSS treatment for Indigenous patients with a history of trauma and SUD. Benbowopka treats approximately 90 patients per year in a residential treatment program, and the program has high quality retrospective data on their programming and outcomes. We propose to benchmark anonymized historical program outcomes by evaluating program outcomes and the impact of program completion on health systems usage. Impact of treatment on health system usage will be determined by linking anonymized patient records with records at the Institute for Clinical and Evaluative Sciences (ICES). ICES linkage will provide further insight into hospitalizations, interaction with emergency, mental health, and primary care usage before and following the implementation of the IHSS intervention. We will respect the Tricouncil Policy Statement, Chapter 9, which highlights the importance of engaging with First Nations throughout all phases of the research process. In addition, we will honour Indigenous knowledge by engaging with Elders and the North Shore Tribal council. Through the data governance protocols established at ICES, we will respect the First Nations principles of ownership, control, access and possession of data (OCAP™). Dr. Jennifer Walker Canada Research Chair in Indigenous Health at the Center for Rural and Northern Health Research and ICES Scientist will oversee the process of data sharing and linking de-identified Benbowopka treatment data to anonymized health system data at ICES. Benbowopka and the North Shore Tribal council will maintain complete ownership over the study data and its subsequent dissemination. Anticipated Outcome: We expect that patients who are treated in the IHSS treatment model will have improved outcomes as compared to previous patients of Benbowopka treated under the abstinence based model of therapy. Objectives measures will include treatment completion, substance use at program completion, substance use at follow-up, ED visits, hospitalization, and death. Patient satisfaction will be tracked using surveys administered at treatment completion and is expected to improve with implementation of IHSS. Impact: We expect to demonstrate that the IHSS is a culturally sensitive and effective treatment model for Indigenous patients who are affected by trauma and substance use disorder.