Search trials – HealthDB

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Recruiting Phase 1

Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118

Psoriasis

The study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a single oral dose in healthy participants. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis .

Начало: 02.05.2025 Край: 28.02.2027 Възраст: 18–65 г. Treatment

New Zealand, United States Jiangsu Hansoh Pharmaceutical Co., Ltd. NCT06846710

Recruiting Phase 1

Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients

Moderate-to-severe Atopic Dermatitis

This Phase 1a/1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). The number of dosing cohorts may be increased or decreased in Part 1 or Part 2. Part 1 (SAD): Healthy participants receiving single doses of TRB-061 or placebo. Part 2 (MAD): Healthy participants receiving multiple doses (3 doses over 8 weeks) of TRB-061 or placebo. Part 3 (Phase 1b): Participants with moderate-to-severe AD receiving repeated doses (4 doses over 12 weeks) of TRB-061 or placebo.

Начало: 02.05.2025 Край: 29.02.2028 Възраст: 18–70 г. Treatment

Australia, New Zealand TRex Bio, Inc. NCT06934252

Recruiting Phase 4

Tirbanibulin for Pediatric Warts

Warts Hand

Warts are common, benign skin lesions caused by the human papillomavirus (HPV). Treatment is challenging, particularly in the pediatric population, where standard modalities such as cryotherapy and intralesional immunotherapy are poorly tolerated. Existing topical treatments, such as imiquimod and 5-fluorouracil, have low efficacy and require prolonged use. Case reports suggest tirbanibulin ointment may provide an effective and well-tolerated alternative for pediatric warts. This study will evaluate the efficacy and safety of tirbanibulin ointment in treating pediatric hand warts.

Начало: 01.05.2025 Край: 30.12.2026 Възраст: 8–18 г.

United States The Skin Center Dermatology Group NCT06791525

Recruiting

Effectiveness of Exercise After an ICD

Heart Arrest Implantable Defibrillator User Physical Activity

This study will test an exercise intervention (E-ICD) following an implantable cardioverter defibrillator.

Начало: 01.05.2025 Край: 30.06.2029 Възраст: от 18 г.

United States University of Washington NCT03544489

Recruiting

Nutrition OUtReach In Systems of Healthcare

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION Autologous Haemopoietic Stem Cell Transplant CAR-T Cell Therapy Food Insecurity

Many children and adults receiving medical treatments have higher costs, which can make it harder for them to afford groceries. When someone can't afford enough food, and they do not receive proper nutrition it can make treatment more difficult. By doing this study investigators hope to learn more about whether addressing food insecurity by giving patients bags of food in clinic can help improve nutrition, reduce costs, and improve transplant and cellular therapy outcomes.

Начало: 01.05.2025 Край: 01.05.2029 Възраст: 8–80 г.

United States University of Kansas Medical Center NCT06802406

Recruiting

SPYRAL GEMINI Pilot Study

Hypertension Vascular Diseases Cardiovascular Diseases Chronic Kidney Diseases +1

The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.

Начало: 01.05.2025 Край: 22.12.2029 Възраст: 18–80 г. Treatment

Australia, Greece, Ireland +2 Medtronic Vascular NCT06907147

Recruiting

Mirror Speech Entrainment: A Novel Technique for Voice Personalized Speech Entrainment for Nonfluent Aphasia

Aphasia Non Fluent Stroke Aphasia

The goal of this clinical trial is to test the use of voice personalization through artificial intelligence (AI) voice cloning on speech entrainment tasks to improve language production of persons with aphasia (PWA). The main question the study aims to answer is: \- What is the impact of personalized voice on speech entrainment in PWA compared to traditional speech entrainment? Speech entrainment is a technique used by speech-language pathologists to improve the speech production of PWA. Traditionally, speech therapists act as the model for participants to speak along with to improve their speech production. This study proposes the use of one's own voice (digitally altered) to improve speech production. The study uses a mobile health approach to administer speech entrainment treatment through a mobile app. * Smartphones with the mobile app pre-installed will be mailed to participants at no cost. * Participants will complete treatment in the comfort of their homes. * The experimental treatments involve: mirror speech entrainment (speaking along to one's own voice) and traditional speech entrainment (speaking along to someone else's voice).

Начало: 01.05.2025 Край: 01.08.2027 Възраст: 18–70 г.

United States University of South Florida NCT06829420

Recruiting Phase 2

Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema

Macular Edema

This is a multi-center, open label study to assess the safety, tolerability, and efficacy of KIO-104 administered by IVT injection to the study eye of eligible participants with macular edema.

Начало: 01.05.2025 Край: 01.12.2026 Възраст: 18–85 г. Treatment

Australia Kiora Pharmaceuticals, Inc. NCT06825702

Recruiting

PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Progressive Pulmonary Fibrosis Interstitial Lung Disease

This is a prospective, observational cohort study. Participants with non-idiopatic pulmonary fibrosis, interstitial lung disease (ILD) will be followed for 24 months to systematically collect clinical, imaging, and biospecimen data. The primary objective is to optimize progressive pulmonary fibrosis (PPF) classification and establish PPF incidence for key ILD subtypes. Additional exploratory objectives are to 1) Prospectively validate a novel PPF classifier and assess performance durability over time, and 2) Determine whether multi-dimensional PPF prediction outperforms component approaches.

Начало: 01.05.2025 Край: 01.12.2029 Възраст: 18–80 г.

Australia, Canada, Ireland +2 University of Massachusetts, Worcester NCT06855329

Recruiting

Evaluation of a Residential In-Reach Program in Regional and Rural Australia

Aged Acute Disease

Residential In-Reach (RIR) programs are designed to provide responsive care for residents in residential aged care homes (RACH) with the aim of avoiding unnecessary hospital transfers. The evidence for their clinical and cost-effectiveness and implementation has been established in urban settings, but there is a small amount of low-quality evidence for rural and regional settings. The Grampians Region Health Service Partnership Resi-In-Reach Redesign Committee will be implementing a new RIR program to be offered to all RACHs in the Grampians region, this project aims to evaluate the clinical and cost-effectiveness of this program, and its implementation in the rural and regional setting. A stepped-wedge trial will be conducted so that as the RIR program is gradually rolled-out across the region, outcomes can be compared in the same facilities across time and between different facilities. The primary outcome measure will be presentation to emergency departments and urgent care centres, and data will also be collected on other clinical outcomes and barriers and enablers of implementing the program. It is anticipated that there will be a reduction in hospital presentations, and a range of barriers and enablers unique to the rural and regional setting will emerge.

Начало: 01.05.2025 Край: 30.06.2026 Възраст: от 65 г. Health services research

Australia Monash University NCT06901167

Recruiting

TEEM-GIFTS: A Gamified mHealth to Reduce Post-Discharge Suicide Risk

Suicide

Patients with mental disorders are at significantly higher risk of suicide after discharge compared to the general population and patients with other diseases. Currently, there is a lack of post-discharge community suicide risk management services in China. The research team's preliminary research suggests that mHealth interventions are well-accepted and feasible for reducing the suicide risk in patients with mental disorders. Furthermore, the inclusion of gamification elements can enhance treatment adherence and user engagement. However, determining the appropriate combination of gamification elements and evaluating the implementation effectiveness of gamified mHealth interventions for suicide risk are challenges in transforming these into regular community mental health services. This study will leverage gamification theory and community-based participatory research to design a gamified mHealth intervention model aimed at reducing suicide risk among discharged patients with mental disorders, and to develop a corresponding management strategy. Using the multi-phase optimization strategy (MOST), the study will identify the optimal combination of gamification elements to reduce suicide risk and increase the outpatient follow-up rate. Through an implementation science framework, the investigators will evaluate the process, outcomes, cost, and feasibility of this management strategy with the goal of reducing suicide risk among these patients. The findings from this study will provide a scientific basis for innovative suicide risk management models for discharged patients with mental disorders in China, thereby paving the way for the application of implementation science in mental health.

Начало: 01.05.2025 Край: 31.12.2027 Възраст: от 18 г.

China Shenzhen Kangning Hospital NCT06358339

Recruiting Phase 3

A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2

Hypertension

GZL2 is an independent study conducted under the GZPL master protocol. GZL2 study will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.

Начало: 30.04.2025 Край: 01.09.2027 Възраст: от 18 г.

Argentina, China, Czechia +8 Eli Lilly and Company NCT06952530

Recruiting

An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies

Vasomotor Symptoms (VMS) Associated With Menopause

This is an observational study to learn more about vasomotor symptoms (VSM) burden and treatment patterns in menopausal women before and after participating in OASIS studies. In this study, data from women with VMS associated with menopause who took part in any of the three OASIS studies and were treated with elizanetant or a placebo, are collected and studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. VMS associated with menopause is a condition in which women who have been through the menopause have hot flashes caused by hormonal changes. Menopause is the stage when a woman stops having menstrual cycles or periods. No investigational products will be administered in this study. The participants in this study already received the standard of care (SOC) treatment for VMS before and after their participation in the study, as part of their regular care from their doctors. The SOC is the treatment that medical experts consider most appropriate currently. OASIS is a set of clinical studies. In this study data will be collected from participants who took part in OASIS 1, 2 or 3 . These three studies assessed the safety and effects of elizanetant compared to a placebo for VMS associated with the menopause. Based on the results of these three studies, Bayer filed a New Drug Application for elizanetant. To better understand the impact of elizanetant on VMS, more knowledge is needed about treatment patterns that were followed for VMS before and after the OASIS studies. The main purpose of this study is to gather real-world data on participants' prescription trends, whether they continued or stopped taking treatments, and healthcare resource utilization, before and after their participation. This study will include participants from OASIS 1,2 or 3 from the United States of America, who have agreed to be contacted to share information regarding their treatment. This study will have 2 parts: Part A - researchers will invite participants to complete an online survey about the treatments given in the year before starting the OASIS study. Part B - researchers will use tokens (an anonymized number to ensure participants' privacy) to learn about the treatments given to them 6 months after the completion of the OASIS study through their anonymized medical records. Researchers will collect the following information: Part A: * the prescription and over-the-counter medicines used by the participants for VMS in the year before the OASIS start * whether they continued or stopped taking them, and * the reason for doing so Part B: * the prescription medicines used by the participants for VMS in 6 months after the OASIS ended * whether they continued or stopped taking them For Part A the data will be collected from the participant survey between March 2025 and June 2025, and for Part B the data will be collected using participants' medical records between April 2025 to May 2025. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.

Начало: 30.04.2025 Край: 15.02.2029 Възраст: 40–65 г.

United States Bayer NCT06949553

Recruiting Phase 4

Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?

Torsion Testis Scrotum Disease

Testicular torsion is a time critical condition for children and young people (CYP). It is difficult to diagnose without an operation. Missing it means the child will lose a testicle. There are no good diagnostic tests, only tests that delay the child's journey to theatre, which puts them at further risk of losing the testicle. Most boys with a painful testicle get a surgical exploration to see if it is torsion and to twist and fix it. Up to 85% of children having surgery will not have torsion. They will have something they didn't need surgery for. We want to see whether a new, low risk, fast investigation could be used to diagnose the problem, meaning no torsions are missed and less children have unnecessary surgery.

Начало: 30.04.2025 Край: 30.06.2026 Възраст: до 19 г.

United Kingdom Sheffield Children's NHS Foundation Trust NCT07545278

Recruiting Phase 1/2

A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer

Triple Negative Breast Cancer

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC). The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).

Начало: 30.04.2025 Край: 01.06.2028 Възраст: от 18 г. Treatment

Australia, South Korea, United States Gilead Sciences NCT06926920

Recruiting Phase 1/2

A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.

Advanced Solid Tumors

This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer (mCRPC) and pancreatic cancer with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes. Condition or disease Intervention/treatment Phase Advanced Solid Tumors Drug: EIK1004 (IMP1707) Phase 1/Phase 2

Начало: 30.04.2025 Край: 01.12.2028 Възраст: 18–89 г. Treatment

Australia, China, United States Eikon Therapeutics NCT06907043

Recruiting Phase 3

A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)

Hypertension

The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the treatment of hypertension in participants with obesity or overweight.

Начало: 30.04.2025 Край: 01.09.2027 Възраст: от 18 г.

Argentina, China, Czechia +8 Eli Lilly and Company NCT06948422

Recruiting Phase 3

A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1

Hypertension Overweight or Obesity

GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.

Начало: 30.04.2025 Край: 01.09.2027 Възраст: от 18 г.

Argentina, China, Czechia +8 Eli Lilly and Company NCT06948435

Recruiting Phase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)

Neoplasms

This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s). This study consists of two stages: Stage 1 (Dose Escalation) and Stage 2 (Dose Expansion). Stage 1 will define the recommended dose(s) for expansion (RDEs) of RO7673396. Stage 2 will evaluate preliminary anti-tumor activity of the RDE(s) defined in Stage 1 and of other doses of interest for future development in selected solid tumor indications.

Начало: 30.04.2025 Край: 25.05.2029 Възраст: от 18 г. Treatment

Australia, Canada, China +7 Hoffmann-La Roche NCT06884618

Recruiting Phase 1/2

Study for AZD4360 in Participants With Advanced Solid Tumours

Gastric Cancer Gastroesophageal Junction Cancer Biliary Tract Cancer Pancreatic Ductal Adenocarcinoma

The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.

Начало: 29.04.2025 Край: 16.12.2027 Възраст: 18–130 г.

China, Germany, Japan +2 AstraZeneca NCT06921928

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