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NCT ID: NCT04323566 Enrolling by invitation - Schizophrenia Clinical Trials

Rituximab Treatment for Psychosis and/or Obsessive Compulsive Disorder With Probable Immune System Involvement

Ra-P-OCD
Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

The primary objective for this study is to evaluate whether Rituximab as compared to placebo is a clinically effective treatment for a subgroup of patients suffering from psychosis and/or obsessive-compulsive disorder (OCD) or -behavior (OCB) where there is an indication of immune system involvement. The secondary objectives of this study are 1. To assess whether Rituximab treatment (with the doses and timing described below) as compared to placebo is associated with amelioration in psychiatric symptomatology 2. To assess whether Rituximab treatment as compared to placebo is associated with improvement in executive functions 3. To assess whether Rituximab treatment as compared to placebo is associated with amelioration in neurological symptoms 4. To evaluate the longevity of psychiatric, neurological and executive improvements associated with Rituximab treatment for up to 16 months after the first infusion (i.e. 12 months after the last infusion) 5. To evaluate whether Rituximab treatment as described is safe for these patients. The exploratory objectives of this study are 1. To assess changes in blood and cerebrospinal fluid (CSF) markers for immune activity associated with Rituximab treatment compared to placebo 2. To assess statistical associations between biological markers in blood or CSF and clinical response 3. To describe changes in somatic symptoms associated with treatment with Rituximab vs placebo for patients with initial symptoms in the questionnaires 4. To describe changes on MR and EEG associated with treatment with Rituximab vs placebo for patients with initial pathology in these examination 5. To study immune mechanisms coupled with psychiatric symptoms, possibly identifying novel biomarkers with potential for subtyping encephalopathies with immune engagement, using biobank cells, blood and CSF samples collected from the participants.

NCT ID: NCT04101058 Enrolling by invitation - Clinical trials for Neuromyelitis Optica Spectrum Disorders

Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders

Momentum
Start date: January 21, 2019
Phase:
Study type: Observational

Neuromyelitis Optica (NMO)/ Neuromyelitis Optica Spectrum Disorders (NMOSD) is an immune-mediated inflammatory demyelinating disease of the central nervous system mainly involving optic nerve and spinal cord. It is clinically characterized by simultaneous or sequential involvement of the optic nerve and spinal cord, presenting a progressive or remission and relapse course, which can lead to paralysis and blindness. The objective of this study is to provide evidence regarding treat effects and factors related to prognosis which will help physicians better evaluable risk-benefit in NMOSD management and improve patients' outcome.

NCT ID: NCT04024553 Enrolling by invitation - Bipolar Disorder Clinical Trials

A Genetic Family Cohort Study of Bipolar Disorder in Chinese Han Population

Start date: March 28, 2019
Phase:
Study type: Observational

This study intends to find out the pathogenic genes of bipolar disorder by collecting the two-phase family of Chinese Han population with the large sample using a family cohort study design, combined with the new generation of high-throughput sequencing technology and Genome-Wide Association Studies (GWAS), Proteomics, bioinformatics analysis, etc., which is expected to be clarified at the genetic level. The pathogenesis of bipolar disorder. At the same time, the investigators will conduct a five-year follow-up of cognitive function, brain function imaging and other major clinical symptoms in patients with bipolar disorder in the core family, and to explore familial bipolar disorder and sporadic biphasic. Differences in the clinical features of the disorder, in order to explore sensitive and specific biomarkers from a multidimensional perspective (cognitive function, brain imaging, genetic features, clinical features, etc.), which may contribute to bipolar disorder in the future. Accurate diagnosis and early identification and prevention have important scientific significance and clinical diagnosis and treatment significance.

NCT ID: NCT03828656 Enrolling by invitation - Clinical trials for PostTraumatic Stress Disorder

NightWare Open Enrollment Study

NWOES
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

This study will provide measures of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.

NCT ID: NCT03655223 Enrolling by invitation - Diabetes Mellitus Clinical Trials

Early Check: Expanded Screening in Newborns

Start date: October 15, 2018
Phase:
Study type: Observational

Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health conditions in addition to providing important data on the implementation of this model program. Early diagnosis may result in health and development benefits for the newborns. Infants who have newborn screening in North Carolina will be eligible to participate, equating to over 120,000 eligible infants a year. Over 95% of participants are expected to screen negative. Newborns who screen positive and their parents are invited to additional research activities and services. Parents can enroll eligible newborns on the Early Check electronic Research Portal. Screening tests are conducted on residual blood from existing newborn screening dried blood spots. Confirmatory testing is provided free-of-charge for infants who screen positive, and carrier testing is provided to mothers of infants with fragile X. Affected newborns have a physical and developmental evaluation. Their parents have genetic counseling and are invited to participate in surveys and interviews. Ongoing evaluation of the program includes additional parent interviews.

NCT ID: NCT03603301 Enrolling by invitation - Strabismus Clinical Trials

Vision in Children Born to Opioid-dependent Methadone-maintained Mothers

VINCH
Start date: July 1, 2017
Phase:
Study type: Observational

The investigators will re-investigate 150 children studied extensively in the past. 100 of these children were born to mothers prescribed methadone during their pregnancy because of opiate dependency, and 50 were comparison children who were not exposed to drugs. These children were investigated when they were newborn babies, and again when they were six months old, and a quarter of the drug-exposed babies had problems with their eyesight, whilst very few of the comparison children has eyesight problems. The investigators would like to see whether the eyesight problems are still present in the children now that they are older. Because they are older, more detailed testing can be undertaken which will help to understand how drug exposure in the womb may have affected their eyesight. The investigators will recruit new, comparison children to the study to match the number of comparison children with the number of drug-exposed children. The findings will be relevant and important when advising mothers on drug use - both prescribed and illicit - when they are pregnant.

NCT ID: NCT03602378 Enrolling by invitation - Asthma Clinical Trials

QoL and Stress in Parents of Children With Developmental Disabilities and Chronic Disease

Start date: April 2, 2018
Phase:
Study type: Observational

The aim of this cross-sectional study is to investigate the level of stress and quality of life in parents of children with developmental disabilities (Down syndrome, autism spectrum disorder, pervasive developmental disorder, cerebral palsy) and parents of children chronic diseases (diabetes mellitus type 1, epilepsy, asthma) compared to parents of healthy children. The investigators will analyze the level of stress, quality of life, self-esteem, optimism, resilience, happiness, stigmatization, depression, anxiety, sleep quality, parenting challenges and some physiological indicators of the stress such as level of cortisol and heart rate variability. Also, the investigators will measure Advanced Glycation End products (AGEs) in the skin. The investigators assume that parents of children with developmental disabilities and chronic diseases have higher level of stress and lower quality of life compared to the parents of healthy children.

NCT ID: NCT03521609 Enrolling by invitation - Clinical trials for Substance Use Disorders

Emotional Intelligence in Patients With Addictive Disorder

Start date: May 25, 2018
Phase: N/A
Study type: Interventional

The study aims to evaluate the level of emotional intelligence in patients diagnosed with substance use disorder and to evaluate the benefits in emotional skills after a brief intervention based on emotional intelligence.

NCT ID: NCT03430180 Enrolling by invitation - Clinical trials for Pathological Gambling

Effects of Intranasal Naloxone on Gambling Urges and Craving in Gambling Disorder

NalGamb
Start date: February 22, 2018
Phase: Phase 2
Study type: Interventional

Primary objective: *To determine whether treatment with naloxone hydrochloride nasal spray reduces gambling urge symptoms in patients with gambling disorder The secondary objectives of the study are: - To determine the effects of naloxone hydrochloride nasal spray on gambling severity, frequency and time, internet use, self-efficacy, quality of life, alcohol consumption, depression - To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of gambling disorder

NCT ID: NCT03337893 Enrolling by invitation - Breast Feeding Clinical Trials

Investigation of Breastfeeding Protection Against Infant Infections and Childhood Diseases

Start date: October 1, 2017
Phase: N/A
Study type: Observational

Objective: It is widely accepted that breastfeeding (AS) is superior to other forms of nutrition in the first six months of life. Breastmilk contains nutrient items in appropriate quantities and a high bioavailability according to the needs of each baby. The United Nations Children's Fund (UNICEF) and the World Health Organization (WHO) recommend that babies take AS alone and then continue to feed on AS with up to two years of age, with appropriate supplementary nutrition, during the first six months of life. Even in the hottest climates, breastfeeding babies have been shown to have no additional nutrient or fluid requirements for the first six months, including water. In the first 6 months of breastfeeding with breast milk alone (YAS), the incidence of many diseases, especially infectious diseases, decreases and the brain development is better. Despite its numerous benefits, mother milk is not utilized in our country sufficiently. According to the Turkish Demographic and Health Survey (TNSA), the rate of breastfeeding in Turkey was 91.8% in Turkey, while the proportion of babies fed only breast milk in the first 6 months was 30.1%. Infants related deaths, otitis media, lower respiratory tract infections, gastroenteritis, obesity were more common in children who were fed formula milk compared to children who were fed breast milk during the first year of life. Obesity can reduce insulin resistance and hypertension risks later in life. According to the research done by Kramer and his colleagues on 13889 children, no effect of breastfeeding on physical development, obesity and hypertension was found. In this study, whether breast feeding was associated with otitis media in the first year, lower respiratory tract infection, gastroenteritis; in the first 5 years of age, obesity and hypertension.