Clinical Research Directory

Treatment of Mandibular Overjet in Children With Maxillary Retrognathism

The project involves a 10-year prospective longitudinal cohort multicentre study where orthodontic treatment and treatment effect is followed in children with Cl III due to maxillary retrognathia who undergo standardized orthodontic interceptive treatment. Standard clinical procedures are followed as usual at each clinic where standard diagnostic and follow up materials are taken before treatment, after treatment and follow ups after 5 and 10 years. The project will not introduce or test new treatment modalities, additional procedures or behavioural regulation in relation to normal clinical practice or new medical devices. The standard diagnostic and follow up materials in each clinic include examination of the dentition, occlusion, craniofacial morphology, and orofacial function. The analyses are based on the following standardized registration methods which are carried out on all the patients. Information from the patient record is included. The patient related outcome measurements will be assessed by five different questionnaires. No biological material is collected for the project.

Evaluating the Effectiveness of an Adapted-Dialectical Behavior Therapy (A-DBT)

Adapted-Dialectical Behavioral Therapy (A-DBT) Adolescence Manual (Urdu version) An A-DBT Adolescence Urdu version Manual was used consisted of techniques related to mindfulness, emotion regulation, interpersonal effectiveness and distress tolerance skills. These skills were drawn from the first edition of the Dialectical Behavioral Therapy (DBT) training manual, and were administered on Juvenile delinquents for 6-weeks.

Evaluation of the Effectiveness of Arthrocentesis Using Catheter in the Treatment of Temporamandibular Joint Disorders

The study focused on arthrocentesis performed using a catheter, aiming to assess its effects on pain perception and mouth opening in patients with TMJ disorders.

Chongqing Adrenogenic Autonomic Cortisol Secretion Cohort Study

To investige the etiology, pathogenesis, diagnosis and treatment of adrenogenic autonomic cortisol secretion in Chinese adults.

The Relationship Between Novel Virological Indicators and Treatment With Different Nucleotide Analogues and the Prognosis of HBV-ACLF Patients

This is an observational study. This study mainly explores the dynamic changes of HBV RNA and HBcrAg during the treatment of HBV-ACLF, as well as the safety of entecavir (ETV), tenofovir alafenamide (TAF) and tenofovir amibufenamide (TMF) during the treatment process, and evaluates the differences in patient prognosis among the three drugs.

Treatment Response in Patients With Medication-Overuse Headache

The aim of this study to evaluate pre-injection patient-related factors that may influence treatment response in patients with medication-overuse headache who underwent ultrasound-guided greater occipital nerve block.

Modulating Exercise Dosage to Improve Concussion Recovery

Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 21 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.

First in Human Study of TLC-ART 101 (ACTU 2001)

This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study is designed to learn whether the formulation can be used as a platform for other drugs for treatment of HIV. The formulation is a drug combination nanoparticle (DCNP). The study will be conducted by UW Positive Research. The sample size for this study is 12-16. The study population consists of healthy adults without HIV. The study duration is 57 days per participant at the start of the study.

A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each. All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.

Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients

The aim of the current study is to evaluate the effect of melatonin administration on circulating levels of inflammatory mediators, oxidative stress, sleep quality, fatigue and quality of life in patients with SLE. To the best of our knowledge, this is the first randomized-controlled trial to evaluate the impact of melatonin on sleep quality and assess fatigue and quality of life in SLE adult patients. Moreover, the impact of melatonin on serum concentrations of Interleukin-6 and superoxide dismutase SOD will be evaluated.

Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal

TUA-VelCo is a single-center randomized controlled superiority trial with blinded methodological assessment. Adult patients hospitalized for alcohol withdrawal and meeting the criteria for Alcohol Use Disorder (AUD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition will be eligible for inclusion. Participants will be randomly assigned to either a cognitive cycling intervention group or a control group. Participants in the experimental group will receive, in addition to standard addiction care, 12 cognitive cycling sessions (three sessions per week over four weeks). The control group will receive standard care combined with 12 scheduled telephone interviews conducted in parallel with the cognitive cycling sessions. Assessments will be conducted at baseline, 1 month (M1), and 3 months (M3) following hospital discharge. The primary outcome will be the proportion of participants maintaining abstinence at M1. Secondary outcomes include maintenance of abstinence at M3 and within-group and between-group changes in craving, cognitive functioning, insight, psychiatric symptoms, and motivation to maintain abstinent. These outcomes will be assessed using validated scales, including the Obsessive Compulsive Drinking Scale, Montreal Cognitive Assessment, Hanil Alcohol Insight Scale, Hamilton Depression Rating Scale, and Hamilton Anxiety Rating Scale. Biomarkers related to alcohol consumption and neuroplasticity will also be evaluated.

Multidimensional Sleep Health Intervention to Optimize Concussion Recovery

Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.

A Real-world Study: Analysis of the Efficacy of Antiviral Therapy in CHB Patients Over 30 Years Old, HBV DNA Positive and ALT Normal

This is a prospective observational study of CHB patients who have not received antiviral treatment but HBV DNA are positive.Investigators aim to explore the antiviral effect and influencing factors of patients over 30 years old with normal ALT level after receiving antiviral treatment.

Surgical Approach to Uterine Septum

The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.

Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML

Venetoclax can bind to the BCL-2 protein, thereby initiating the apoptosis program and exerting anti-AML effects. The induction regimen combining venetoclax with hypomethylating agents (HMA) significantly improves the remission rate (over 60%) in elderly unfit AML patients and markedly prolongs survival in those achieving complete remission. Isocitrate dehydrogenase (IDH) 1 and 2 are involved in the citric acid cycle. Approximately 20% of AML patients carry IDH1 or IDH2 mutations, which lead to the reduction of α-ketoglutarate to 2-hydroxyglutarate (2-HG). 2-HG can cause histone methylation and inhibit TET2 activity, resulting in DNA hypermethylation, thereby affecting gene expression and cell differentiation. IDH mutations are more common in elderly patients and are often associated with cytogenetic abnormalities; they may also co-occur with FLT3-ITD, NPM1, or DNMT3A mutations. Ivosidenib is an IDH1 inhibitor, and previous studies have confirmed its safety and efficacy in AML treatment. According to adult AML treatment guidelines, IDH-mutated patients eligible for intensive chemotherapy may receive IDH inhibitors during induction therapy. Based on the study by Montesinos et al. on the role of ivosidenib and azacitidine in IDH-mutated AML, for patients ineligible for intensive chemotherapy, a new treatment option has been added: IDH1-mutated AML patients may receive ivosidenib (500 mg, days 1-28) combined with azacitidine (75 mg/m²/day for 7 days) in 28-day cycles, or ivosidenib monotherapy. Recent studies have shown that a triple-drug regimen comprising ivosidenib, venetoclax, and azacitidine demonstrates excellent efficacy and safety. In chemotherapy-ineligible patients, the triple regimen achieved a composite complete remission rate (CRc) of 86% and an overall response rate (ORR) of 92%. At a median follow-up of 27.4 months, the 2-year overall survival (OS) was 72%, and the 2-year event-free survival (EFS) was 72%. Therefore, this study aims to conduct a multicenter, single-arm clinical trial to preliminarily evaluate the long-term efficacy of this combination in adult AML.

The Role of Platelet-rich Plasma Local Injection as Treatment in Improvement of Pilonidal Sinus Surgery Outcomes

The aim of the present study is to find How Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease.

Intrastromal Injection of Fluconazole in Treatment of Fungal Keratitis

This study aimed to evaluate the Safety and the Effectiveness of Intrastromal Injection of Fluconazole in The Treatment of Fungal Keratitis.

Facilitators and Barriers to Eptinezumab Administration in Thailand

This research study is designed as a longitudinal prospective descriptive study using mixed-method data collection. Eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody (anti-CGRP mAb), is administered by intravenous (IV) infusion every 3 months as preventive medication for individuals with migraine who have been diagnosed based on theInternational Classification of Headache Disorders, 3rd edition (ICHD-3) by headache specialist neurologists. The goal of this study is to understand the real-life experiences of people with migraine who receive eptinezumab in a hospital setting in Thailand, a middle-income country. The researchers want to learn about what makes it easier or harder for patients and healthcare workers to use this treatment. The main questions it aims to answer are: * What are the barriers and facilitators to using eptinezumab from the perspectives of patients and healthcare providers? * Does eptinezumab reduce monthly migraine days and improve quality of life over time? Participants will: * (For migraine patients) Take part in an in-depth interview (IDI) within 24 hours after receiving an eptinezumab infusion * (For migraine patients) Complete questionnaires about migraine symptoms, disability, and quality of life at baseline, 3 months, and 6 months * (For healthcare providers) Take part in a one-time interview about their experiences administering eptinezumab The study will also look at how well eptinezumab works by measuring changes in monthly migraine days and other health scores over a 6-month period. The information from this study may help improve migraine care in Thailand and support better access to new treatments like eptinezumab.

A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor

This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.

Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment

Generally, pediatric patients tolerate acute toxicities but are vulnerable to late effects. Thus, increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing. In this CCCG-HL-2024 study, Brentuximab vedotin (Bv) was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study, respectively, to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma (cHL) in children, adolescents and young adults. On the premise of maintaining a 4-year event free survival (EFS)\>90% in the low-, intermediate-and high-risk groups, increase the early assessment complete response rate (the overall early complete response rate increased by 20%, that is, from 54.0% to 74.0%) to further reduce the proportion of children receiving radiotherapy to benefit them.

A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty

A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells

Rituximab Combining Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)

This randomized, open-label study aim to compare the efficacy and safety of rituximab combining anti-CD38 monoclonal antibody with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.

Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)

This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.