Clinical Trials Logo

Filter by:
NCT ID: NCT05184569 Recruiting - Semantic Dementia Clinical Trials

Veri-T: A Trial of Verdiperstat in Patients With svPPA Due to TDP-43 Pathology

Veri-T-001
Start date: April 19, 2022
Phase: Phase 1
Study type: Interventional

The purpose of the study is to test the safety and tolerability of twice daily Verdiperstat in patients with semantic variant primary progressive aphasia (svPPA) due to frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP). Three-fourths of the participants will receive Verdiperstat and one-fourth will receive Placebo during the 24-week treatment duration.

NCT ID: NCT05197192 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL

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

This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation or complex karyotype).

NCT ID: NCT05198726 Recruiting - Clinical trials for Mild Cognitive Impairment

Speed of Processing (SoP) Training Plus α-tACS

aMCIUp
Start date: April 19, 2022
Phase: N/A
Study type: Interventional

The current proposal aims to assess if the combination of Speed of Processing (SoP) training with alpha tACS (α-tACS) is able to increase brain speed of processing as assessed by the Useful Field of View (UFOV) when comparing to SoP training plus sham α-tACS. Moreover, a second aim is to assess if those changes in speed of processing transfer to other cognitive domains, such as memory, language and executive functioning. Furthermore, the mechanisms underlying these interventions will be tested, namely to assess brain connectivity and coherence as assessed by EEG. To that purpose, the aim of the current proposal is to conduct a double-blind, parallel randomized trial assessing the effects of combining SoP with alpha endogenous tACS (either active or sham) in participants with Mild Cognitive impairment (MCI).

NCT ID: NCT05218772 Recruiting - Clinical trials for Moderate or Serious Haemophilia

Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry

SENIORHEMO
Start date: April 19, 2022
Phase:
Study type: Observational [Patient Registry]

Background: Elderly people with serious haemophilia (PwSH), i.e., with moderate or severe haemophilia, have major comorbidities due to consequences of haemophilia. Also, the comorbidities related to age are added. Despite the existence of numerous studies on the objective health status of elderly PwSH, some limitations may be stated (need to update the results in a more contemporary context, no studies conducted in France, highlighted determinants focused on demographic and clinical factors). On the contrary, the perceived health status of elderly PwSH has been little described. Only two studies specifically addressed the quality of life (QoL) of elderly PwSH. These studies reported an altered QoL in some domains, in comparison with reference values from the general population. However, some limitations may also be stated (need to bring results in a more contemporary context, no studies conducted in France, highlighted determinants focused on clinical factors). Since serious haemophilia is a rare disease, studies are often performed on a small number of subjects. The present project relies on the FranceCoag registry, a unique exhaustive national cohort of PwSH followed over time among whom 612 are elderly PwSH. Objectives: Main objective: to describe the objective and perceived health status of elderly (≥60 y.o.) PwSH from of a French exhaustive national registry, and to compare their health status with that of the French general elderly population. Secondary objective: to identify individual (demographic, clinical, social, psycho-cognitive) and collective characteristics (related to healthcare organisation), associated with the objective and perceived health status of elderly PwSH in France. Materials and Methods: A national, multicentric, observational, cross-sectional study will be conducted. It will be based on the participation of elderly PwSH already included in the FranceCoag registry. Each eligible participant will receive a questionnaire to complete concerning: objective health status; perceived health status (QoL assessed by the WHOQOL-Old questionnaire); demographic data; social data; psycho-cognitive data (anxious symptoms, depressive symptoms, use of coping strategies, time perspective). Therapeutic and clinical data related to haemophilia will be collected via the FranceCoag registry database. Data concerning healthcare organisation will be collected directly from investigators of Haemophilia Treatment Centres. The main analysis will consist in the description and comparison of the health status with reference data from the French general elderly population. Standardisation methods will be used to take into account a potential imbalance between the study population and the reference population, related to age and especially to sex, as haemophilia is a predominantly male disease. The secondary analysis will consist in the identification of potential determinants of the health status. Structural equation models will be performed to take into account the complexity of the relationships between the determinants. Impact of the proposal Better understanding the impact of the disease on patients' experience is essential in a systematic global perspective of health, that aims to care and support the individual not only as a patient but also as a person in his/her environment. This study based on a registry will allow to improve the knowledge by updating literature data on the health status of elderly PwSH, adding elements to the rare literature data on the perceived health status, providing data in the French specific context, and identifying both classical and more original determinants of health status of elderly PwSH. These results will be used to better identify elderly PwSH at high risk of poor health status, to propose recommendations and to set up actions to offer them an adapted support, and to elaborate new versions of public health plans dedicated to haemophilia or to rare diseases.

NCT ID: NCT05259059 Recruiting - Breastfeeding Clinical Trials

Feeding Mom Feeding Infant's Microbiota: Nutritional Strategies for Improving Breast Milk Composition and Infant Health

Start date: April 19, 2022
Phase:
Study type: Observational

The first 1000 days, i.e., the earliest stage of life, is a unique period of opportunity to establish the foundations of human growth and health through the lifespan. In the recent decades, multiple studies have explored nutritional strategies for improving infant health through improving the nutritive and bioactive compositions in breast milk. For example, dietary fiber intake has been increasingly reported to benefit the health of the mother-infant dyad. However, the complex interplays among maternal diet, breast milk composition, infant gut microbiota and infant development are yet to be elucidated in a prospective cohort. In addition, the investigators' previous work has revealed unsatisfactory dietary patterns in Hong Kong lactating women, with clear inadequacy in fruit and vegetable intake. In this prospective cohort study, the investigators aim to recruit 100 healthy Chinese mother-child pairs. Data on maternal and infant dietary intake, breast milk composition, gut microbiota profile will be collected and the investigators will examine their associations with the health outcomes in infants. In addition, the influence of dietary factors and genetic predisposition on breast milk components and its associated benefits in the child will be interrogated. With the employment of multidisciplinary research approaches, cutting-edge biotechnologies and the omics platforms, this project will provide novel insights into the dietary factors and breastfeeding practices that are beneficial to the infant developmental trajectory, and the potential roles of breast milk composition in shaping infant's gut microbiota and the associated health impact in the long term. More importantly, the investigators hope to generate more solid scientific data to inform the public of the importance of maternal diet and the practical nutritional strategies to improve breast milk composition for the sake of the child.

NCT ID: NCT05281809 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia

Start date: April 19, 2022
Phase: Phase 2
Study type: Interventional

This trial aims to demonstrate the feasibility of this approach to reliably generate product and to safely administer the product to patients who have B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia.

NCT ID: NCT05285839 Recruiting - Atopic Dermatitis Clinical Trials

Dupixent and Narrowband UVB for Atopic Dermatitis

Start date: April 19, 2022
Phase: Phase 4
Study type: Interventional

24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.

NCT ID: NCT05289050 Recruiting - Clinical trials for Postoperative Pain, Acute

Analgesic Effect of Intraoperative Intravenous S-Ketamine During Total Knee Arthroplasty Surgery

Start date: April 19, 2022
Phase: Phase 4
Study type: Interventional

Severe acute pain after total knee arthroplasty surgery has multiple implications for hospitals and patients, monopolising resources and affecting the quality of life. S-ketamine inhibits N-methyl-d-aspartate (NMDA) receptor activation and attenuates central sensitization associated with hyperalgesia, opioid tolerance.Therefore, the primary aim of this trial was to investigate whether s-ketamine decreases pain and opioid consumption postoperatively in adult individuals undergoing total knee arthroplasty surgery.

NCT ID: NCT05293496 Recruiting - Clinical trials for Advanced Solid Tumor

A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors

Start date: April 19, 2022
Phase: Phase 1
Study type: Interventional

Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab (MGD019). The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, metastatic castration-resistant prostate cancer (mCRPC), melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled. Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years. Tumor assessments are performed every 8 weeks (± 7 days) for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD). Participants will be followed for safety throughout the study. .

NCT ID: NCT05296187 Recruiting - Injection Site Clinical Trials

Efficacy of TEAS On Prevention of Propofol Injection Pain in Children

Start date: April 19, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the efficacy of transcutaneous electrical acupoint stimulation for the prevention of propofol injection pain in children.