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NCT ID: NCT06183788 Recruiting - Clinical trials for Anti-NMDA Receptor Encephalitis

Antibody-mediated NMDA Receptor Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Prolonged Recovery Stage

AMENDS
Start date: January 16, 2023
Phase: N/A
Study type: Interventional

The encephalitis mediated by antibodies against the NMDA receptor (NMDARe) predominantly affects young adults and children resulting in severe neurologic and psychiatric deficits. After overcoming the acute stage, patients are left with long-lasting behavioral, cognitive, and psychiatric alterations with important socio-family-economical implications. Here investigators postulate that a better knowledge of this stage will improve treatment decisions and outcome. In Aim 1, the post-acute stage will be clinically characterized, tools to remotely follow cognitive, behavioral and psychiatric deficits will be provided, and the impact of cognitive rehabilitation will be assessed. In Aim 2, biomarkers (autoimmune, inflammatory, neuronal injury) will be identified as signatures of the acute and post-acute stages. In Aim 3, a mouse model of NMDARe will be used to determine the underlying mechanisms and treatment of the postacute stage.

NCT ID: NCT06183086 Recruiting - Pressure Ulcer Clinical Trials

PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries

TRELINOIL
Start date: November 14, 2023
Phase:
Study type: Observational

To assess the safety and performance of Linovera® in the treatment of Category- I pressure ulcers/injuries.

NCT ID: NCT06182085 Recruiting - Clinical trials for Mild Cognitive Impairment Due to Alzheimer's Disease

Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD)

PRImus-AD
Start date: December 1, 2023
Phase: Phase 2
Study type: Interventional

Alzheimer's disease (AD) is the most common form of dementia. In the brains of people with AD, certain small substances stick together. This leads to changes in thinking and behaviour. The company PRInnovation is developing a new treatment for Alzheimer's disease, called PRI-002. It is thought that PRI-002 can cut the sticked substances back into small pieces. That would reduce the effects of Alzheimer's disease. In the current study the investigators examine whether PRI-002 is safe and effective in participants with mild cognitive impairment (MCI) or mild dementia due to AD.

NCT ID: NCT06181435 Recruiting - Dermatitis Atopic Clinical Trials

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).

NCT ID: NCT06180993 Recruiting - RSV Infection Clinical Trials

Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization

NIRSE-GAL
Start date: September 25, 2023
Phase:
Study type: Observational

A longitudinal observational study based on routinely collected data on hospital and health care use for RSV infections will be undertaken. The Galician public health registries will be used for data collection including baseline information and follow-up data. Historical data will be retrieved for comparison purposes. The study aims to observe and analyze data from all the eligible children in Galicia for nirsevimab treatment. The number of eligible children is expected to be approximately 14,000 per each RSV season.

NCT ID: NCT06179511 Recruiting - Clinical trials for Hematological Malignancies

Study of AZD9829 in CD123+ Hematological Malignancies

Start date: January 31, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in participants with CD123 positive hematological malignancies.

NCT ID: NCT06179160 Recruiting - Solid Tumors Clinical Trials

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Start date: January 4, 2024
Phase: Phase 1
Study type: Interventional

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

NCT ID: NCT06178614 Recruiting - Clinical trials for Advanced Solid Tumors

A Study of JNJ-87890387 for Advanced Solid Tumors

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

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).

NCT ID: NCT06177912 Recruiting - Clinical trials for Pneumococcal Infection

A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

STRIDE-13
Start date: January 18, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

NCT ID: NCT06177262 Recruiting - Insight Impaired Clinical Trials

Characteristics of Illness Awareness in Anorexia Nervosa

Start date: December 1, 2022
Phase:
Study type: Observational

Objective: To study the characteristics of illness awareness, its dimensions and its evolution in relation to clinical, cognitive and psychosocial variables in patients with anorexia nervosa. Design: observational longitudinal design. Method: First, the process of translating and culturally adapting the Schedule for the Assessment of Insight in Eating Disorders (SAI-ED) to Spanish will be carried out and, over 9 months, patients who are admitted to the Eating Disorders Unit of the Hospital de la Santa Creu I Sant Pau (HSCSP) and the Eating Disorders Unit of the H. Mutua de Terrassa will be offered to participate in the study. Through individual clinical interviews and self-reports, a first sample will be collected to allow the validation study of the scale in the Spanish population. The sample will include patients with Anorexia Nervosa and Bulimia Nervosa who understand and speak Spanish or Catalan and sign the informed consent for participation. Participants will be recruited consecutively until N=80 is reached. From a subsample of patients with anorexia nervosa, data related to illness awareness and other clinical, cognitive and psychosocial variables will be collected longitudinally in the 3 and 6 months after. Finally, a quantitative analysis of the results obtained will be carried out.